diff --git a/Criterion_eval.ipynb b/Criterion_eval.ipynb new file mode 100644 index 0000000..7f0f0bd --- /dev/null +++ b/Criterion_eval.ipynb @@ -0,0 +1,4907 @@ +{ + "cells": [ + { + "cell_type": "markdown", + "id": "d73de630-162c-4e86-a049-9e4090a6b59a", + "metadata": {}, + "source": [ + "The notebook is a comprehensive data analysis script that processes and merges multiple datasets related to patient trials, preparing the data for further modeling or evaluation. It begins by reading a Parquet file 'TrialGPT-Criterion-Annotations/data/train-00000-of-00001.parquet' into a DataFrame df_parquet, and a TSV file 'TrialGPT/dataset/sigir/qrels/test.tsv' into df_tsv. To facilitate merging, the TSV file's columns are renamed to match those in df_parquet (renaming 'query-id' to 'patient_id' and 'corpus-id' to 'trial_id'). The notebook performs data cleaning by trimming whitespace from string columns and examines unique values and distributions within columns to understand the data's structure. An inner merge on ['patient_id', 'trial_id'] results in df_joined, and the script identifies unmatched records to assess the completeness and integrity of the merge.\n", + "\n", + "Subsequently, the notebook reads a JSON Lines file 'TrialGPT/dataset/sigir/queries.jsonl', which contains patient query data, and filters it to include only those patient IDs present in df_joined. This filtered dataset is saved for future use. A further merge combines the filtered queries with df_joined, producing df_final, which consolidates patient information, trial data, and associated scores. The notebook conducts statistical analyses on df_final, such as calculating the distribution of matching scores, aggregating statistics on the number of trials per patient, and examining the distinct criteria texts associated with patients. Visualizations, including histograms and bar plots, depict distributions of trials per patient and criteria per patient, aiding in identifying patterns or anomalies in the data.\n", + "\n", + "In the later sections, the focus shifts to data sampling and preparation for detailed analysis. The script filters patients who have exactly two trials and a specific range of distinct criteria (between 15 and 25), randomly selecting five patients for an in-depth examination. Corresponding query data for these patients is saved to 'TrialGPT/dataset/sigir/mini_filtered_queries.jsonl'. Finally, the notebook reads and processes a JSON file containing trial rankings ('TrialGPT/results/trial_rankings/all_rankings.json'), flattens the nested JSON structure into a DataFrame, and provides summary statistics on the number of patients and trials. This prepares the data for subsequent analysis or modeling steps, ensuring that the dataset is well-understood and ready for advanced processing." + ] + }, + { + "cell_type": "markdown", + "id": "0b8131a5-a6f2-4d97-8866-f3958873da29", + "metadata": {}, + "source": [ + "## Summary of the current work:\n", + "\n", + "This notebook focuses on analyzing and comparing different eligibility assessments for clinical trials, involving patient data, trial information, and various eligibility labels. The main steps and analyses include:\n", + "\n", + "1. Data Loading and Preprocessing:\n", + " - Loaded multiple datasets: trial annotations, patient queries, trial corpus, and matching results.\n", + " - Performed data cleaning, merging, and filtering operations to create comprehensive datasets.\n", + "\n", + "2. Data Analysis:\n", + " - Analyzed distributions of trials per patient and criteria per patient.\n", + " - Examined the structure and content of various datasets, including patient summaries and trial criteria.\n", + "\n", + "3. Eligibility Label Comparison:\n", + " - Created a merged dataset combining information from multiple sources.\n", + " - Compared three types of eligibility labels: expert-annotated, GPT-4 generated, and algorithm-predicted.\n", + " - Used confusion matrices, F1 scores, and classification reports to evaluate the performance of different labeling methods.\n", + "\n", + "4. Visualization:\n", + " - Created various plots to visualize the distribution of scores, criteria, and performance metrics.\n", + "\n", + "5. Detailed Comparison:\n", + " - Generated tables highlighting discrepancies between different eligibility assessments.\n", + " - Analyzed cases where predictions differed from expert annotations or GPT-4 assessments.\n", + "\n", + "Contrast with the initial summary:\n", + "\n", + "The initial summary at the top of the notebook described a data processing pipeline focused on merging and preparing datasets for modeling. It mentioned:\n", + "- Reading and processing Parquet and TSV files.\n", + "- Merging datasets based on patient and trial IDs.\n", + "- Basic statistical analyses and visualizations of the merged data.\n", + "- Sampling and filtering operations to create a subset of data for detailed analysis.\n", + "\n", + "The current work goes significantly beyond this initial scope:\n", + "1. Depth of Analysis: While the initial summary focused on data preparation, the current work delves deep into comparing and analyzing different eligibility assessments.\n", + "2. Multiple Data Sources: The current analysis incorporates more data sources, including GPT-4 generated labels and algorithm predictions, which weren't mentioned in the initial summary.\n", + "3. Advanced Analytical Techniques: The notebook employs more sophisticated analytical methods, such as confusion matrices, F1 scores, and detailed classification reports.\n", + "4. Focus on Eligibility Assessment: The current work specifically targets the comparison of different methods for determining trial eligibility, which wasn't a focus in the initial summary.\n", + "5. Visualization and Interpretation: The notebook includes more advanced visualizations and interpretations of the results, providing deeper insights into the performance of different eligibility assessment methods.\n", + "\n", + "In essence, while the initial summary described a data preparation process, the current work represents a comprehensive analysis of clinical trial eligibility assessments, comparing expert annotations with AI-generated predictions and exploring the nuances and discrepancies between these different approaches." + ] + }, + { + "cell_type": "code", + "execution_count": 1, + "id": "6dc689cf-e9a2-4224-8d74-118129ba9f0e", + "metadata": {}, + "outputs": [], + "source": [ + "import os\n", + "import glob\n", + "import json\n", + "import random\n", + "import numpy as np\n", + "import pandas as pd\n", + "import seaborn as sns\n", + "import matplotlib.pyplot as plt\n", + "from sklearn.metrics import confusion_matrix, f1_score, classification_report\n", + "\n", + "# Set pandas display options \n", + "pd.set_option('display.max_rows', 1)\n", + "pd.set_option('display.max_columns', None)\n", + "pd.set_option('display.width', None)\n", + "pd.set_option('display.max_colwidth', 300)" + ] + }, + { + "cell_type": "code", + "execution_count": 2, + "id": "4d9775c8-d319-4116-9599-ee4452a81c96", + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "import os\n", + "import glob\n", + "import json\n", + "import random\n", + "import numpy as np\n", + "import pandas as pd\n", + "import seaborn as sns\n", + "import matplotlib.pyplot as plt\n", + "from sklearn.metrics import confusion_matrix, f1_score, classification_report\n" + ] + } + ], + "source": [ + "def clean_and_sort_imports(import_list):\n", + " # Split each import statement into lines\n", + " imports = import_list.split('\\n')\n", + " \n", + " # Remove empty lines, strip whitespace, and remove duplicates\n", + " unique_imports = list(dict.fromkeys(line.strip() for line in imports if line.strip()))\n", + " \n", + " # Sort imports by length, then alphabetically for imports of the same length\n", + " sorted_imports = sorted(unique_imports, key=lambda x: (len(x), x))\n", + " \n", + " return sorted_imports\n", + "\n", + "# Example usage:\n", + "imports = \"\"\"\n", + "import pandas as pd\n", + "import pandas as pd\n", + "import pandas as pd\n", + "import pandas as pd\n", + "import json\n", + "import os\n", + "import glob\n", + "import json\n", + "import random\n", + "import numpy as np\n", + "import pandas as pd\n", + "import seaborn as sns\n", + "import matplotlib.pyplot as plt\n", + "from sklearn.metrics import confusion_matrix, f1_score, classification_report\n", + "import matplotlib.pyplot as plt\n", + "\"\"\"\n", + "\n", + "cleaned_sorted_imports = clean_and_sort_imports(imports)\n", + "\n", + "# Print the cleaned and sorted imports\n", + "for imp in cleaned_sorted_imports:\n", + " print(imp)" + ] + }, + { + "cell_type": "code", + "execution_count": 3, + "id": "9ccfa219-6894-4ab1-9ae2-a87076e1b55f", + "metadata": {}, + "outputs": [], + "source": [ + "# Read the Parquet file\n", + "parquet_file = '../TrialGPT-Criterion-Annotations/data/train-00000-of-00001.parquet'\n", + "df_parquet = pd.read_parquet(parquet_file)" + ] + }, + { + "cell_type": "code", + "execution_count": 4, + "id": "681e9162-4d85-4907-842d-62f8ff1079eb", + "metadata": {}, + "outputs": [], + "source": [ + "# if not pre downloaded use this below, or download from hf \n", + "# df_parquet = pd.read_parquet(\"hf://datasets/ncbi/TrialGPT-Criterion-Annotations/data/train-00000-of-00001.parquet\")\n", + "# https://huggingface.co/datasets/ncbi/TrialGPT-Criterion-Annotations" + ] + }, + { + "cell_type": "code", + "execution_count": 5, + "id": "32bd9a35-cecc-4c27-8773-80e898d51e12", + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "Parquet DataFrame:\n" + ] + }, + { + "data": { + "text/html": [ + "
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annotation_idpatient_idnotetrial_idtrial_titlecriterion_typecriterion_textgpt4_explanationexplanation_correctnessgpt4_sentencesexpert_sentencesgpt4_eligibilityexpert_eligibilitytraining
00sigir-201410. A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life.\\n1. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, ...NCT01397994Study to Assess Efficacy of Nicorandil+Atenolol vs Atenolol in Treatment of Chronic Stable Angina.inclusionPatients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes.The patient note does not provide direct evidence of the patient having chronic stable angina or having undergone an Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. However, the patient does present with symptoms of chest pain, which could be i...Correct[0, 1, 2][0, 1, 2]not enough informationnot enough informationTrue
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" + ], + "text/plain": [ + " annotation_id patient_id \\\n", + "0 0 sigir-20141 \n", + ".. ... ... \n", + "\n", + " note \\\n", + "0 0. A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life.\\n1. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, ... \n", + ".. ... \n", + "\n", + " trial_id \\\n", + "0 NCT01397994 \n", + ".. ... \n", + "\n", + " trial_title \\\n", + "0 Study to Assess Efficacy of Nicorandil+Atenolol vs Atenolol in Treatment of Chronic Stable Angina. \n", + ".. ... \n", + "\n", + " criterion_type \\\n", + "0 inclusion \n", + ".. ... \n", + "\n", + " criterion_text \\\n", + "0 Patients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. \n", + ".. ... \n", + "\n", + " gpt4_explanation \\\n", + "0 The patient note does not provide direct evidence of the patient having chronic stable angina or having undergone an Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. However, the patient does present with symptoms of chest pain, which could be i... \n", + ".. ... \n", + "\n", + " explanation_correctness gpt4_sentences expert_sentences \\\n", + "0 Correct [0, 1, 2] [0, 1, 2] \n", + ".. ... ... ... \n", + "\n", + " gpt4_eligibility expert_eligibility training \n", + "0 not enough information not enough information True \n", + ".. ... ... ... \n", + "\n", + "[1015 rows x 14 columns]" + ] + }, + "execution_count": 5, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "# Print both DataFrames\n", + "print(\"Parquet DataFrame:\")\n", + "df_parquet" + ] + }, + { + "cell_type": "code", + "execution_count": 6, + "id": "b44c2c8b-f61d-40d1-b264-e9ec78f5a37f", + "metadata": {}, + "outputs": [], + "source": [ + "# Load the TSV file\n", + "tsv_file = 'dataset/sigir/qrels/test.tsv'\n", + "df_tsv = pd.read_csv(tsv_file, sep='\\t', names=['query-id', 'corpus-id', 'score'])" + ] + }, + { + "cell_type": "code", + "execution_count": 7, + "id": "eb03d212-b88e-4cc4-bd6d-b1718a3c2d73", + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "\n", + "DataFrame Info:\n", + "\n", + "RangeIndex: 3836 entries, 0 to 3835\n", + "Data columns (total 3 columns):\n", + " # Column Non-Null Count Dtype \n", + "--- ------ -------------- ----- \n", + " 0 query-id 3836 non-null object\n", + " 1 corpus-id 3836 non-null object\n", + " 2 score 3836 non-null object\n", + "dtypes: object(3)\n", + "memory usage: 90.0+ KB\n", + "None\n", + "\n", + "DataFrame Description:\n", + " query-id corpus-id score\n", + "count 3836 3836 3836\n", + "... ... ... ...\n", + "\n", + "[4 rows x 3 columns]\n", + "\n", + "Value counts for query-id:\n", + "query-id\n", + "sigir-20147 153\n", + " ... \n", + "Name: count, Length: 5, dtype: int64\n", + "\n", + "Value counts for corpus-id:\n", + "corpus-id\n", + "NCT00455468 5\n", + " ..\n", + "Name: count, Length: 5, dtype: int64\n", + "\n", + "Value counts for score:\n", + "score\n", + "0 2733\n", + " ... \n", + "Name: count, Length: 4, dtype: int64\n", + "First few rows of the DataFrame:\n" + ] + }, + { + "data": { + "text/html": [ + "
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" + ], + "text/plain": [ + " query-id corpus-id score\n", + "0 query-id corpus-id score\n", + ".. ... ... ...\n", + "\n", + "[5 rows x 3 columns]" + ] + }, + "execution_count": 7, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "# Display info about the DataFrame\n", + "print(\"\\nDataFrame Info:\")\n", + "print(df_tsv.info())\n", + "\n", + "# Display basic statistics of the DataFrame\n", + "print(\"\\nDataFrame Description:\")\n", + "print(df_tsv.describe())\n", + "\n", + "# Display value counts for each column\n", + "for column in df_tsv.columns:\n", + " print(f\"\\nValue counts for {column}:\")\n", + " print(df_tsv[column].value_counts().head())\n", + "\n", + "# # Optional: Save to CSV for easy viewing in spreadsheet software\n", + "# df_tsv.to_csv('test_tsv_data.csv', index=False)\n", + "# print(\"\\nDataFrame saved to 'test_tsv_data.csv'\")# Display the first few rows of the DataFrame\n", + "\n", + "# Display the first few rows of the DataFrame\n", + "print(\"First few rows of the DataFrame:\")\n", + "df_tsv.head()" + ] + }, + { + "cell_type": "code", + "execution_count": 8, + "id": "d1967460-59e8-4d03-a42f-80d39462d464", + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "annotation_id:\n", + " Number of unique values: 1015\n", + " First few unique values: [0, 1, 2, 3, 4]\n", + "\n", + "patient_id:\n", + " Number of unique values: 53\n", + " First few unique values: ['sigir-20141', 'sigir-201410', 'sigir-201411', 'sigir-201412', 'sigir-201413']\n", + "\n", + "note:\n", + " Number of unique values: 53\n", + " First few unique values: ['0. 64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c.\\n1. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise.\\n2. She complains of a painful skin lesion on the left lower leg.\\n3. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.\\n4. The patient will provide informed consent, and will comply with the trial protocol without any practical issues.', '0. A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath.\\n1. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications.\\n2. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption.\\n3. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min.\\n4. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema.\\n5. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.\\n6. The patient will provide informed consent, and will comply with the trial protocol without any practical issues.', \"0. A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings.\\n1. No history of headache or night terrors.\\n2. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.\\n3. The patient will provide informed consent, and will comply with the trial protocol without any practical issues.\", '0. A 15-year-old girl presents to the ER with abdominal pain.\\n1. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours.\\n2. She has had no appetite since yesterday but denies diarrhea.\\n3. She has had no sexual partners and her menses are regular.\\n4. On examination, she has localized rebound tenderness over the right lower quadrant.\\n5. On an abdominal ultrasound, a markedly edematous appendix is seen.\\n6. The patient will provide informed consent, and will comply with the trial protocol without any practical issues.', '0. A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability.\\n1. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm.\\n2. The abdominal exam demonstrates tenderness and enlarged liver.\\n3. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified.\\n4. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.\\n5. The patient will provide informed consent, and will comply with the trial protocol without any practical issues.']\n", + "\n", + "trial_id:\n", + " Number of unique values: 103\n", + " First few unique values: ['NCT00015626', 'NCT00034437', 'NCT00084240', 'NCT00149227', 'NCT00163709']\n", + "\n", + "trial_title:\n", + " Number of unique values: 103\n", + " First few unique values: ['A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients', 'A Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)', 'A Prospective Randomized Study Evaluating the Recurrence Rate of Chronic Subdural Hematoma After Placing a Subperiosteal Drainage Compared to a Subdural Drainage', 'A Single-Center, Exploratory Study to Analyze the Dynamics of Skin Microflora Following Exposure to Surfactants', 'A Study Comparing Safety and Efficacy of Levofloxacin and Metronidazole Versus Piperacillin/Tazobactam in Treating Complicated Appendicitis']\n", + "\n", + "criterion_type:\n", + " Number of unique values: 2\n", + " First few unique values: ['exclusion', 'inclusion']\n", + "\n", + "criterion_text:\n", + " Number of unique values: 1002\n", + " First few unique values: ['Patients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes.', 'Male and female', 'Age 25 to 65 years', 'Patient must understand and be willing, able and likely to comply with all study procedures and restrictions and comprehends the diary cards.', 'Patient must be able to give voluntary written informed consent.']\n", + "\n", + "gpt4_explanation:\n", + " Number of unique values: 982\n", + " First few unique values: ['First, the criterion is applicable as the patient is presenting with shortness of breath. However, the patient is 30 years old, which does not meet the age requirement of the criterion. There is no information about the emergency department triage category of the patient. Therefore, the patient does not meet the criterion due to age, and there is not enough information about the triage category.', 'First, the criterion is applicable because the patient is not explicitly excluded from it. The patient note does not provide direct evidence of the patient using any drugs other than LT4 or having a known pathology that may affect GIS absorption. However, the patient note does not mention any medication use at all, which makes it difficult to infer whether the patient is using LT4 or any other drugs. Furthermore, there is no mention of any known pathology that may affect GIS absorption. If such conditions were present, it is likely they would be mentioned in the patient note. Therefore, it can be inferred that the patient does not meet this exclusion criterion.', 'First, this criterion is applicable because the patient has a condition (wheezing) that could potentially be treated with steroids. However, there is no direct evidence in the patient note indicating that the patient has inhaled or ingested steroids. If the patient had been using steroids, it would likely be mentioned in the patient note due to its medical importance. Therefore, we can infer that the patient has not used steroids.', 'Since there are no exclusion criteria listed for this clinical trial, the patient is not excluded based on any criteria.', 'The chest x-ray is mentioned in sentence 6, but it only shows hyperinflation with no consolidation, which does not indicate progression or new abnormalities.']\n", + "\n", + "explanation_correctness:\n", + " Number of unique values: 3\n", + " First few unique values: ['Correct', 'Incorrect', 'Partially Correct']\n", + "\n", + "gpt4_sentences:\n", + " Number of unique values: 47\n", + " First few unique values: ['[0, 1, 2, 3, 4]', '[0, 1, 2, 3, 6]', '[0, 1, 2, 3]', '[0, 1, 2, 4, 6, 8]', '[0, 1, 2, 4, 7, 8, 9]']\n", + "\n", + "expert_sentences:\n", + " Number of unique values: 53\n", + " First few unique values: ['[0, 1, 2, 3, 4, 5, 6]', '[0, 1, 2, 3, 4]', '[0, 1, 2, 3, 6]', '[0, 1, 2, 3]', '[0, 1, 2, 4, 5, 6, 7, 8, 9]']\n", + "\n", + "gpt4_eligibility:\n", + " Number of unique values: 6\n", + " First few unique values: ['excluded', 'included', 'not applicable', 'not enough information', 'not excluded']\n", + "\n", + "expert_eligibility:\n", + " Number of unique values: 6\n", + " First few unique values: ['excluded', 'included', 'not applicable', 'not enough information', 'not excluded']\n", + "\n", + "training:\n", + " Number of unique values: 2\n", + " First few unique values: [False, True]\n", + "\n" + ] + } + ], + "source": [ + "# Dictionary to store the results\n", + "column_stats = {}\n", + "\n", + "# Loop through each column\n", + "for column in df_parquet.columns:\n", + " # Get unique values\n", + " unique_values = df_parquet[column].unique()\n", + " \n", + " # Convert to list and sort (if possible)\n", + " try:\n", + " unique_list = sorted(unique_values.tolist())\n", + " except TypeError:\n", + " # If sorting fails (e.g., for mixed types), just convert to list without sorting\n", + " unique_list = unique_values.tolist()\n", + " \n", + " # Store in dictionary\n", + " column_stats[f\"{column}_list\"] = unique_list\n", + " \n", + " # Print summary\n", + " print(f\"{column}:\")\n", + " print(f\" Number of unique values: {len(unique_list)}\")\n", + " print(f\" First few unique values: {unique_list[:5]}\") # Show first 5 values\n", + " print()\n", + "\n", + "# Now column_stats dictionary contains lists for each column\n", + "# You can access them like this: column_stats['patient_id_list']\n", + "\n", + "# # Optional: Save to file\n", + "# import json\n", + "# with open('column_stats.json', 'w') as f:\n", + "# json.dump(column_stats, f, indent=2)\n", + "# print(\"Results saved to column_stats.json\")" + ] + }, + { + "cell_type": "code", + "execution_count": 9, + "id": "995e89c2-9d38-45bf-a0aa-d2a739956510", + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "\n", + "Joined DataFrame Info:\n", + "\n", + "RangeIndex: 1015 entries, 0 to 1014\n", + "Data columns (total 15 columns):\n", + " # Column Non-Null Count Dtype \n", + "--- ------ -------------- ----- \n", + " 0 patient_id 1015 non-null object\n", + " 1 trial_id 1015 non-null object\n", + " 2 score 997 non-null object\n", + " 3 annotation_id 1015 non-null int64 \n", + " 4 note 1015 non-null object\n", + " 5 trial_title 1015 non-null object\n", + " 6 criterion_type 1015 non-null object\n", + " 7 criterion_text 1014 non-null object\n", + " 8 gpt4_explanation 1015 non-null object\n", + " 9 explanation_correctness 1015 non-null object\n", + " 10 gpt4_sentences 1015 non-null object\n", + " 11 expert_sentences 1015 non-null object\n", + " 12 gpt4_eligibility 1015 non-null object\n", + " 13 expert_eligibility 1015 non-null object\n", + " 14 training 1015 non-null bool \n", + "dtypes: bool(1), int64(1), object(13)\n", + "memory usage: 112.1+ KB\n", + "None\n", + "\n", + "Joined DataFrame Description:\n", + " annotation_id\n", + "count 1015.0\n", + "... ...\n", + "\n", + "[8 rows x 1 columns]\n", + "\n", + "Number of rows in df_tsv: 3836\n", + "Number of rows in df_parquet: 1015\n", + "Number of rows in joined DataFrame: 1015\n", + "Number of distinct patient_ids: 53\n", + "\n", + "Distinct patient_ids as a list:\n", + "['sigir-20141', 'sigir-20142', 'sigir-20143', 'sigir-20144', 'sigir-20145', 'sigir-20146', 'sigir-20147', 'sigir-20148', 'sigir-20149', 'sigir-201410', 'sigir-201411', 'sigir-201412', 'sigir-201413', 'sigir-201414', 'sigir-201415', 'sigir-201416', 'sigir-201417', 'sigir-201418', 'sigir-201419', 'sigir-201420', 'sigir-201421', 'sigir-201422', 'sigir-201423', 'sigir-201424', 'sigir-201425', 'sigir-201426', 'sigir-201427', 'sigir-201429', 'sigir-201430', 'sigir-20151', 'sigir-20152', 'sigir-20153', 'sigir-20154', 'sigir-20155', 'sigir-20156', 'sigir-20157', 'sigir-20158', 'sigir-20159', 'sigir-201510', 'sigir-201511', 'sigir-201512', 'sigir-201513', 'sigir-201514', 'sigir-201515', 'sigir-201516', 'sigir-201517', 'sigir-201518', 'sigir-201519', 'sigir-201520', 'sigir-201521', 'sigir-201522', 'sigir-201523', 'sigir-201524']\n" + ] + }, + { + "data": { + "text/html": [ + "
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patient_idtrial_idscoreannotation_idnotetrial_titlecriterion_typecriterion_textgpt4_explanationexplanation_correctnessgpt4_sentencesexpert_sentencesgpt4_eligibilityexpert_eligibilitytraining
0sigir-20141NCT01397994100. A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life.\\n1. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, ...Study to Assess Efficacy of Nicorandil+Atenolol vs Atenolol in Treatment of Chronic Stable Angina.inclusionPatients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes.The patient note does not provide direct evidence of the patient having chronic stable angina or having undergone an Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. However, the patient does present with symptoms of chest pain, which could be i...Correct[0, 1, 2][0, 1, 2]not enough informationnot enough informationTrue
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" + ], + "text/plain": [ + " patient_id trial_id score annotation_id \\\n", + "0 sigir-20141 NCT01397994 1 0 \n", + ".. ... ... ... ... \n", + "\n", + " note \\\n", + "0 0. A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life.\\n1. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, ... \n", + ".. ... \n", + "\n", + " trial_title \\\n", + "0 Study to Assess Efficacy of Nicorandil+Atenolol vs Atenolol in Treatment of Chronic Stable Angina. \n", + ".. ... \n", + "\n", + " criterion_type \\\n", + "0 inclusion \n", + ".. ... \n", + "\n", + " criterion_text \\\n", + "0 Patients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. \n", + ".. ... \n", + "\n", + " gpt4_explanation \\\n", + "0 The patient note does not provide direct evidence of the patient having chronic stable angina or having undergone an Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. However, the patient does present with symptoms of chest pain, which could be i... \n", + ".. ... \n", + "\n", + " explanation_correctness gpt4_sentences expert_sentences \\\n", + "0 Correct [0, 1, 2] [0, 1, 2] \n", + ".. ... ... ... \n", + "\n", + " gpt4_eligibility expert_eligibility training \n", + "0 not enough information not enough information True \n", + ".. ... ... ... \n", + "\n", + "[1015 rows x 15 columns]" + ] + }, + "execution_count": 9, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "# Rename columns in df_tsv to match df_parquet\n", + "# This step ensures that the column names used for merging are consistent across both dataframes\n", + "df_tsv = df_tsv.rename(columns={'query-id': 'patient_id', 'corpus-id': 'trial_id'})\n", + "\n", + "# Perform the join\n", + "# We're using a right join here, which keeps all rows from df_parquet and matching rows from df_tsv\n", + "# This is important because it ensures we don't lose any data from df_parquet, contains our main dataset\n", + "df_joined = pd.merge(df_tsv, df_parquet, on=['patient_id', 'trial_id'], how='right') \n", + "\n", + "# Display info about the joined DataFrame\n", + "# This gives us an overview of the resulting dataframe, including column names and data types\n", + "print(\"\\nJoined DataFrame Info:\")\n", + "print(df_joined.info())\n", + "\n", + "# Display basic statistics of the joined DataFrame\n", + "# This provides summary statistics for numerical columns, helping us understand the data distribution\n", + "print(\"\\nJoined DataFrame Description:\")\n", + "print(df_joined.describe())\n", + "\n", + "# Display the number of rows in each DataFrame\n", + "# This helps us verify if we've lost or gained any rows during the merge operation\n", + "print(f\"\\nNumber of rows in df_tsv: {len(df_tsv)}\")\n", + "print(f\"Number of rows in df_parquet: {len(df_parquet)}\")\n", + "print(f\"Number of rows in joined DataFrame: {len(df_joined)}\")\n", + "\n", + "# Extract unique patient IDs from the joined DataFrame\n", + "# This helps us understand how many distinct patients are in our dataset\n", + "distinct_patient_ids = df_joined['patient_id'].unique()\n", + "\n", + "# Calculate and print the number of distinct patients\n", + "# This gives us a quick count of how many unique patients we're dealing with\n", + "num_distinct_patients = len(distinct_patient_ids)\n", + "print(f\"Number of distinct patient_ids: {num_distinct_patients}\")\n", + "\n", + "# Convert unique patient IDs to a list and print them\n", + "# This allows us to see all unique patient IDs, which can be useful for debugging or further analysis\n", + "distinct_patient_ids_list = distinct_patient_ids.tolist()\n", + "print(\"\\nDistinct patient_ids as a list:\")\n", + "print(distinct_patient_ids_list)\n", + "\n", + "# Display the entire joined DataFrame\n", + "# This allows us to see the structure and content of our merged data\n", + "df_joined" + ] + }, + { + "cell_type": "code", + "execution_count": 10, + "id": "61fe2d9d-a53d-4cc7-938f-3c31e9295311", + "metadata": {}, + "outputs": [ + { + "data": { + "text/html": [ + "
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0sigir-20141A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is ...
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59 rows × 2 columns

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" + ], + "text/plain": [ + " _id \\\n", + "0 sigir-20141 \n", + ".. ... \n", + "\n", + " text \n", + "0 A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is ... \n", + ".. ... \n", + "\n", + "[59 rows x 2 columns]" + ] + }, + "execution_count": 10, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "# Read the JSONL file from the dataset\n", + "# This file is part of the TrialGPT dataset and contains query information\n", + "# The 'queries.jsonl' file likely includes patient information\n", + "jsonl_file = 'dataset/sigir/queries.jsonl'\n", + "queries = []\n", + "\n", + "# Open the file and read it line by line\n", + "with open(jsonl_file, 'r') as file:\n", + " for line in file:\n", + " # Parse each line as a JSON object and append it to the queries list\n", + " # This approach is memory-efficient for large files as it processes one line at a time\n", + " queries.append(json.loads(line))\n", + "\n", + "# Convert the list of dictionaries (parsed JSON objects) to a pandas DataFrame\n", + "# This transformation allows for easier data manipulation and analysis using pandas functions\n", + "df_queries = pd.DataFrame(queries)\n", + "\n", + "# Display the entire DataFrame\n", + "# This allows us to inspect the structure and content of the queries data from the dataset\n", + "df_queries" + ] + }, + { + "cell_type": "code", + "execution_count": 11, + "id": "f35a0263-0277-4ce9-90df-c289bc20cae9", + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "Total number of queries: 59\n", + "Number of queries after filtering: 52\n", + "Number of queries removed: 7\n", + "\n", + "First few rows of filtered queries:\n", + " _id \\\n", + "0 sigir-20141 \n", + ".. ... \n", + "\n", + " text \n", + "0 A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is ... \n", + ".. ... \n", + "\n", + "[5 rows x 2 columns]\n" + ] + } + ], + "source": [ + "# Filter df_queries to keep only the _ids present in df_joined's patient_id\n", + "# This step ensures we only work with queries that have corresponding data in our joined dataset\n", + "df_queries_filtered = df_queries[df_queries['_id'].isin(df_joined['patient_id'])]\n", + "\n", + "# Display information about the filtering process\n", + "# This helps us understand how many queries were kept and how many were removed\n", + "print(f\"Total number of queries: {len(df_queries)}\")\n", + "print(f\"Number of queries after filtering: {len(df_queries_filtered)}\")\n", + "print(f\"Number of queries removed: {len(df_queries) - len(df_queries_filtered)}\")\n", + "\n", + "# Display the first few rows of the filtered queries DataFrame\n", + "# This allows us to inspect the structure and content of the filtered data\n", + "print(\"\\nFirst few rows of filtered queries:\")\n", + "print(df_queries_filtered.head())\n", + "\n", + "\n", + "# Total number of queries: 59\n", + "# Number of queries after filtering: 52\n", + "# # Number of queries removed: 7\n", + "# What this means:\n", + "\n", + "# The original queries.jsonl file contained information for 59 patients.\n", + "# After filtering, we're left with 52 patients that have corresponding data in the df_joined DataFrame.\n", + "# 7 patients were removed during the filtering process.\n", + "\n", + "# A \"removed query\" in this context refers to a patient entry that exists in the queries.jsonl file (which is part of the TrialGPT dataset for testing) but does not have a corresponding entry in the TrialGPT-Criterion-Annotations set (represented by df_joined).\n", + "\n", + "# These removed queries are significant because:\n", + "\n", + "# They represent patients that are part of the testing dataset but not part of the annotation set.\n", + "# This discrepancy could be intentional, possibly to test the model's performance on unseen data.\n", + "# It highlights the difference between the full testing dataset and the subset that has detailed annotations.\n", + "\n", + "# The filtering step ensures that we're working with a consistent set of patients across our different data sources. However, it's important to note that by removing these 7 queries, we might be excluding some test cases that were intended to evaluate the model's performance on patients not seen in the training data.\n", + "\n", + "# This observation is crucial for understanding the scope of our analysis and any potential limitations in our evaluation process. It also underscores the importance of carefully considering how we handle data that appears in one dataset but not another when working with multiple related datasets." + ] + }, + { + "cell_type": "markdown", + "id": "532d3ebe-3f12-41bf-a598-b87501268974", + "metadata": {}, + "source": [ + "# Importance of this step:" + ] + }, + { + "cell_type": "markdown", + "id": "8c41553c-1483-42a0-938c-062876dbf30f", + "metadata": {}, + "source": [ + "### don't run with min_to_run openAI branch need full queries.jsonl for qrels = GenericDataLoader" + ] + }, + { + "cell_type": "code", + "execution_count": 12, + "id": "d275ad43-30ae-47a9-b375-5df01bb5295a", + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "\n", + "Filtered queries saved to dataset/sigir/filtered_queries.jsonl\n" + ] + } + ], + "source": [ + "# Optional: Save filtered queries to a new JSONL file\n", + "# This step creates a new dataset that only includes patients with corresponding annotations\n", + "output_file = 'dataset/sigir/filtered_queries.jsonl'\n", + "with open(output_file, 'w') as file:\n", + " for _, row in df_queries_filtered.iterrows():\n", + " json.dump(row.to_dict(), file)\n", + " file.write('\\n')\n", + "print(f\"\\nFiltered queries saved to {output_file}\")\n", + "\n", + "# # Optional: Save filtered queries to CSV for easy viewing\n", + "# df_queries_filtered.to_csv('filtered_queries.csv', index=False)\n", + "# print(\"Filtered queries also saved to filtered_queries.csv\")\n", + "\n", + "# Importance of this step:\n", + "# Data Consistency: By saving only the filtered queries, we ensure that our dataset aligns perfectly with the annotation data. This consistency is crucial for accurate model evaluation.\n", + "# Resource Efficiency: As you correctly pointed out, we're avoiding unnecessary processing of data for which we don't have annotations. This saves computational resources and time.\n", + "# Replication Focus: By using just the annotation data, we're focusing on replicating the results based on the subset of data that has been expertly annotated. This allows for a more direct comparison with the reported results.\n", + "# Reducing Noise: Excluding patients without annotations eliminates potential noise or inconsistencies that could arise from trying to process or predict outcomes for patients lacking expert-labeled data.\n", + "# Why this approach is safe:\n", + "# Data Integrity: We're not altering or manipulating the content of the queries, just selecting a subset. This preserves the integrity of the individual patient data.\n", + "# Traceability: By creating a new file, we maintain a clear record of which queries were used in our analysis, making our process transparent and reproducible.\n", + "# Original Data Preservation: The original dataset remains untouched, allowing us to always refer back to it if needed.\n", + "# Controlled Environment: This approach creates a controlled dataset that matches exactly with our annotation data, reducing variables that could affect our ability to replicate the reported results.\n", + "# Alignment with Best Practices: In machine learning and data science, it's common and often recommended to work with a clearly defined and consistent dataset, especially when trying to replicate results.\n", + "# By taking this approach, you're creating a more controlled environment for your analysis, which is crucial when attempting to replicate and verify reported results. It allows you to focus on the core task of eligibility assessment based on expert-annotated data, without introducing potential confounding factors from unannotated cases." + ] + }, + { + "cell_type": "code", + "execution_count": 13, + "id": "29aa689d-a28b-450c-a656-5696c237770e", + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "\n", + "Number of unique _ids in filtered queries: 52\n", + "Number of unique patient_ids in df_joined: 53\n", + "\n", + "Number of patient_ids in df_joined not present in filtered queries: 1\n", + "\n", + "Number of _ids in filtered queries not present in df_joined: 0\n", + "Extra patient_ids in df_joined:\n", + "sigir-201426\n", + "\n", + "Full rows for extra IDs in df_joined:\n", + " patient_id trial_id score annotation_id \\\n", + "481 sigir-201426 NCT00373048 NaN 481 \n", + ".. ... ... ... ... \n", + "\n", + " note \\\n", + "481 0. A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil.\\n1. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates.\\n2. Malaria Chemoprophylaxis is indicated but three of the women are in diff... \n", + ".. ... \n", + "\n", + " trial_title \\\n", + "481 Mefloquine Prophylaxis in HIV-1 Individuals: a Randomized Placebo-controlled Trial \n", + ".. ... \n", + "\n", + " criterion_type criterion_text \\\n", + "481 inclusion Permanent residents of the Luanshya district \n", + ".. ... ... \n", + "\n", + " gpt4_explanation \\\n", + "481 The patient note does not provide any information about the patient's residence. However, it is mentioned that the patient is preparing for a trip to the Amazon Rainforest region in Brazil, which does not suggest that the patient is a resident of the Luanshya district in Zambia. Therefore, it is... \n", + ".. ... \n", + "\n", + " explanation_correctness gpt4_sentences expert_sentences gpt4_eligibility \\\n", + "481 Partially Correct [0] [0] not included \n", + ".. ... ... ... ... \n", + "\n", + " expert_eligibility training \n", + "481 not enough information False \n", + ".. ... ... \n", + "\n", + "[18 rows x 15 columns]\n", + "\n", + "Confirming counts:\n", + "df_queries_filtered '_id' count: 52\n", + "df_joined 'patient_id' count: 1015\n" + ] + } + ], + "source": [ + "# Display the number of unique _ids in the filtered queries\n", + "# This helps us understand how many distinct patients we have in our filtered query dataset\n", + "print(f\"\\nNumber of unique _ids in filtered queries: {df_queries_filtered['_id'].nunique()}\")\n", + "\n", + "# Display the number of unique patient_ids in df_joined\n", + "# This shows how many distinct patients we have in our joined dataset\n", + "print(f\"Number of unique patient_ids in df_joined: {df_joined['patient_id'].nunique()}\")\n", + "\n", + "# Find patient_ids in df_joined that are not in df_queries_filtered\n", + "# This identifies any patients in the joined dataset that don't have corresponding queries\n", + "extra_ids = set(df_joined['patient_id']) - set(df_queries_filtered['_id'])\n", + "print(f\"\\nNumber of patient_ids in df_joined not present in filtered queries: {len(extra_ids)}\")\n", + "\n", + "# Check for any _ids in filtered queries not present in df_joined's patient_id\n", + "# This identifies any queries that don't have corresponding patient data in the joined dataset\n", + "missing_ids = set(df_queries_filtered['_id']) - set(df_joined['patient_id'])\n", + "print(f\"\\nNumber of _ids in filtered queries not present in df_joined: {len(missing_ids)}\")\n", + "if missing_ids:\n", + " print(\"Sample of missing _ids:\", list(missing_ids)[:5])\n", + "\n", + "# If there are extra IDs in df_joined, print them and their corresponding rows\n", + "if extra_ids:\n", + " print(\"Extra patient_ids in df_joined:\")\n", + " for id in extra_ids:\n", + " print(id)\n", + " \n", + " # Retrieve and print the full rows for these extra IDs in df_joined\n", + " extra_rows = df_joined[df_joined['patient_id'].isin(extra_ids)]\n", + " print(\"\\nFull rows for extra IDs in df_joined:\")\n", + " print(extra_rows)\n", + "else:\n", + " print(\"No extra patient_ids found in df_joined.\")\n", + "\n", + "# Double-check the counts to ensure consistency\n", + "print(f\"\\nConfirming counts:\")\n", + "print(f\"df_queries_filtered '_id' count: {df_queries_filtered['_id'].count()}\")\n", + "print(f\"df_joined 'patient_id' count: {df_joined['patient_id'].count()}\")\n", + "\n", + "\n", + "# Number of unique _ids in filtered queries: 52\n", + "# Number of unique patient_ids in df_joined: 53\n", + "\n", + "# Number of patient_ids in df_joined not present in filtered queries: 1\n", + "\n", + "# Number of _ids in filtered queries not present in df_joined: 0\n", + "# Extra patient_ids in df_joined:\n", + "# sigir-201426\n", + "# Confirming counts:\n", + "# df_queries_filtered '_id' count: 52\n", + "# df_joined 'patient_id' count: 1015\n", + "# ```\n", + "\n", + "# These counts indeed indicate that we have one more annotated patient in the TrialGPT-Criterion-Annotations dataset than we do in the filtered queries.jsonl file. Here's the detailed explanation:\n", + "\n", + "# 1. Unique Patients Discrepancy:\n", + "# - We have 52 unique patients in the filtered queries dataset.\n", + "# - We have 53 unique patients in the joined dataset (df_joined).\n", + "# - This immediately shows us that there's one extra patient in the annotations.\n", + "\n", + "# 2. Extra Patient Identification:\n", + "# - The code identified one patient ID (sigir-201426) that exists in df_joined but not in the filtered queries.\n", + "# - This confirms that we have an additional annotated patient that doesn't have a corresponding query in the queries.jsonl file.\n", + "\n", + "# 3. No Missing Queries:\n", + "# - There are 0 query IDs that exist in the filtered queries but not in df_joined.\n", + "# - This means all the patients in our queries dataset have corresponding annotations.\n", + "\n", + "# 4. Total Annotation Count:\n", + "# - The df_joined 'patient_id' count is 1015, which likely represents the total number of annotations (not unique patients).\n", + "# - This suggests that on average, we have about 19 annotations per patient (1015 / 53 ≈ 19).\n", + "\n", + "# 5. Consistency in Filtered Queries:\n", + "# - The filtered queries dataset has 52 entries, matching the number of unique IDs.\n", + "# - This indicates that each patient in the queries dataset has exactly one query entry.\n", + "\n", + "# Implications:\n", + "\n", + "# 1. Data Completeness: We have more annotated data than query data.\n", + "\n", + "# 2. Potential for Analysis: The extra patient (sigir-201426) in the annotations dataset provides an opportunity to examine why this discrepancy exists. It could be due to:\n", + "# - An intentional addition for testing purposes.\n", + "# - A data collection or processing error.\n", + "# - A patient that was annotated but whose query was later removed for some reason.\n", + "\n", + "# 3. Data Integrity: The fact that all filtered queries have corresponding annotations is a positive sign for data integrity.\n", + "\n", + "# 4. Comprehensive Annotations: With an average of 19 annotations per patient, we have a rich dataset for analysis, likely covering multiple criteria or trials per patient.\n", + "\n", + "# This discrepancy, while small, is important to note for several reasons:\n", + "# - It ensures transparency in your data processing pipeline.\n", + "# - It may affect how you calculate certain statistics or perform your analysis.\n", + "# - It provides an opportunity to investigate why this extra patient exists in the annotations and whether it should be included or excluded in further analysis.\n", + "\n", + "# Understanding these nuances in your dataset is crucial for accurate analysis and interpretation of results, especially when trying to replicate or validate previous findings." + ] + }, + { + "cell_type": "code", + "execution_count": 14, + "id": "33b3de50-59d9-4ef1-9b90-2c71c70683c1", + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "Number of rows in final joined DataFrame: 997\n", + "Number of unique patients: 52\n", + "Number of unique trials: 101\n", + "\n", + "Count of scores:\n", + "score\n", + "1 598\n", + " ... \n", + "Name: count, Length: 2, dtype: int64\n", + "\n", + "Percentage of each score:\n", + "score\n", + "1 59.97994\n", + " ... \n", + "Name: count, Length: 2, dtype: float64\n", + "\n", + "Basic statistics of scores:\n", + "count 997\n", + " ... \n", + "Name: score, Length: 4, dtype: object\n", + "\n", + "Score distribution plot saved as 'score_distribution.png'\n" + ] + }, + { + "data": { + "text/html": [ + "
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patient_idtexttrial_idscoreannotation_idnotetrial_titlecriterion_typecriterion_textgpt4_explanationexplanation_correctnessgpt4_sentencesexpert_sentencesgpt4_eligibilityexpert_eligibilitytraining
0sigir-20141A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is ...NCT01397994100. A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life.\\n1. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, ...Study to Assess Efficacy of Nicorandil+Atenolol vs Atenolol in Treatment of Chronic Stable Angina.inclusionPatients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes.The patient note does not provide direct evidence of the patient having chronic stable angina or having undergone an Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. However, the patient does present with symptoms of chest pain, which could be i...Correct[0, 1, 2][0, 1, 2]not enough informationnot enough informationTrue
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997 rows × 16 columns

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" + ], + "text/plain": [ + " patient_id \\\n", + "0 sigir-20141 \n", + ".. ... \n", + "\n", + " text \\\n", + "0 A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is ... \n", + ".. ... \n", + "\n", + " trial_id score annotation_id \\\n", + "0 NCT01397994 1 0 \n", + ".. ... ... ... \n", + "\n", + " note \\\n", + "0 0. A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life.\\n1. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, ... \n", + ".. ... \n", + "\n", + " trial_title \\\n", + "0 Study to Assess Efficacy of Nicorandil+Atenolol vs Atenolol in Treatment of Chronic Stable Angina. \n", + ".. ... \n", + "\n", + " criterion_type \\\n", + "0 inclusion \n", + ".. ... \n", + "\n", + " criterion_text \\\n", + "0 Patients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. \n", + ".. ... \n", + "\n", + " gpt4_explanation \\\n", + "0 The patient note does not provide direct evidence of the patient having chronic stable angina or having undergone an Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. However, the patient does present with symptoms of chest pain, which could be i... \n", + ".. ... \n", + "\n", + " explanation_correctness gpt4_sentences expert_sentences \\\n", + "0 Correct [0, 1, 2] [0, 1, 2] \n", + ".. ... ... ... \n", + "\n", + " gpt4_eligibility expert_eligibility training \n", + "0 not enough information not enough information True \n", + ".. ... ... ... \n", + "\n", + "[997 rows x 16 columns]" + ] + }, + "execution_count": 14, + "metadata": {}, + "output_type": "execute_result" + }, + { + "data": { + "image/png": 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", + "text/plain": [ + "
" + ] + }, + "metadata": {}, + "output_type": "display_data" + } + ], + "source": [ + "# Rename the '_id' column in df_queries_filtered to 'patient_id' for consistency in the join operation\n", + "df_queries_filtered = df_queries_filtered.rename(columns={'_id': 'patient_id'})\n", + "\n", + "# Perform an inner join between df_queries_filtered and df_joined on the 'patient_id' column\n", + "# This ensures we only keep rows where patient_id exists in both dataframes\n", + "df_final = pd.merge(df_queries_filtered, df_joined, on='patient_id', how='inner')\n", + "\n", + "# Display basic information about the joined DataFrame\n", + "print(f\"Number of rows in final joined DataFrame: {len(df_final)}\")\n", + "print(f\"Number of unique patients: {df_final['patient_id'].nunique()}\")\n", + "print(f\"Number of unique trials: {df_final['trial_id'].nunique()}\")\n", + "\n", + "# Count the occurrences of each score value\n", + "score_counts = df_final['score'].value_counts().sort_index()\n", + "print(\"\\nCount of scores:\")\n", + "print(score_counts)\n", + "\n", + "# Calculate the percentage distribution of scores\n", + "score_percentages = (score_counts / len(df_final)) * 100\n", + "print(\"\\nPercentage of each score:\")\n", + "print(score_percentages)\n", + "\n", + "# Compute and display basic statistical measures of the scores\n", + "print(\"\\nBasic statistics of scores:\")\n", + "print(df_final['score'].describe())\n", + "\n", + "# Visualize the distribution of scores\n", + "plt.figure(figsize=(10, 6))\n", + "score_counts.plot(kind='bar')\n", + "plt.title('Distribution of Scores')\n", + "plt.xlabel('Score')\n", + "plt.ylabel('Count')\n", + "plt.tight_layout()\n", + "# plt.savefig('score_distribution.png') # Uncomment to save the plot\n", + "print(\"\\nScore distribution plot saved as 'score_distribution.png'\")\n", + "\n", + "# Display the entire final joined DataFrame\n", + "df_final\n", + "\n", + "\n", + "# Number of rows in final joined DataFrame: 997\n", + "# Number of unique patients: 52\n", + "# Number of unique trials: 101\n", + "\n", + "# Count of scores:\n", + "# score\n", + "# 1 598\n", + "# 2 399\n", + "# Name: count, dtype: int64\n", + "\n", + "# Percentage of each score:\n", + "# score\n", + "# 1 59.97994\n", + "# 2 40.02006\n", + "# Name: count, dtype: float64\n", + "\n", + "# Basic statistics of scores:\n", + "# count 997\n", + "# unique 2\n", + "# top 1\n", + "# freq 598\n", + "# Name: score, dtype: object\n", + "\n", + "\n", + "# 1. 997 rows: This number represents the total patient-trial combinations in our final dataset. It's less than the 1015 we saw earlier because:\n", + "# - We filtered out the one patient (sigir-201426) that was in the annotations but not in the queries.\n", + "# - The inner join operation only kept rows where patient IDs existed in both the filtered queries and the joined dataset.\n", + "\n", + "# 2. 52 unique patients: This matches exactly with the number of unique patients we had in our filtered queries dataset. It confirms that we've successfully maintained all the patients from our queries in the final dataset.\n", + "\n", + "# 3. 101 unique trials: This shows how many different clinical trials are represented in our dataset. Each patient might be evaluated for multiple trials.\n", + "\n", + "# 4. Score distribution:\n", + "# - We only have two score values: 1 and 2.\n", + "# - Score 1 appears 598 times (59.98% of the cases)\n", + "# - Score 2 appears 399 times (40.02% of the cases)\n", + "\n", + "# This distribution tells us that our dataset is slightly imbalanced, with more instances of score 1 than score 2. In the context of clinical trial eligibility, these scores likely represent different levels of eligibility or relevance.\n", + "\n", + "# The fact that we have 997 rows (patient-trial combinations) for 52 patients means that, on average, each patient is evaluated for about 19 trials (997 / 52 ≈ 19.17). This aligns with our earlier observation about the number of annotations per patient." + ] + }, + { + "cell_type": "code", + "execution_count": 15, + "id": "472f0eaf-0f14-4ea2-92f7-cbe281fcc435", + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "\n", + "Distribution of trials per patient:\n", + "trial_id\n", + "1 1\n", + " ..\n", + "Name: count, Length: 2, dtype: int64\n", + "\n", + "Patients with the most trials (2):\n", + "['sigir-20141', 'sigir-201410', 'sigir-201411', 'sigir-201412', 'sigir-201413', 'sigir-201414', 'sigir-201415', 'sigir-201416', 'sigir-201417', 'sigir-201418', 'sigir-201419', 'sigir-20142', 'sigir-201420', 'sigir-201421', 'sigir-201422', 'sigir-201423', 'sigir-201424', 'sigir-201425', 'sigir-201427', 'sigir-201429', 'sigir-20143', 'sigir-201430', 'sigir-20144', 'sigir-20145', 'sigir-20146', 'sigir-20147', 'sigir-20148', 'sigir-20149', 'sigir-20151', 'sigir-201510', 'sigir-201511', 'sigir-201512', 'sigir-201513', 'sigir-201514', 'sigir-201515', 'sigir-201516', 'sigir-201517', 'sigir-201518', 'sigir-201519', 'sigir-20152', 'sigir-201520', 'sigir-201521', 'sigir-201522', 'sigir-201523', 'sigir-201524', 'sigir-20153', 'sigir-20154', 'sigir-20155', 'sigir-20156', 'sigir-20157', 'sigir-20158']\n", + "\n", + "Patients with the least trials (1):\n", + "['sigir-20159']\n", + "Statistics of distinct criteria per patient:\n", + "count 52.0\n", + " ... \n", + "Name: criterion_text, Length: 8, dtype: float64\n", + "\n", + "Distribution of distinct criteria per patient:\n", + "criterion_text\n", + "4 1\n", + " ..\n", + "Name: count, Length: 27, dtype: int64\n", + "\n", + "Percentage distribution of distinct criteria per patient:\n", + "criterion_text\n", + "4 1.923077\n", + " ... \n", + "Name: count, Length: 27, dtype: float64\n", + "\n", + "Distribution plot saved as 'criteria_per_patient_distribution.png'\n" + ] + }, + { + "data": { + "image/png": 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" + ] + }, + "metadata": {}, + "output_type": "display_data" + } + ], + "source": [ + "# Count the number of unique trials for each patient\n", + "trials_per_patient = df_final.groupby('patient_id')['trial_id'].nunique().sort_values(ascending=False)\n", + "\n", + "# Display the distribution of trials per patient\n", + "print(\"\\nDistribution of trials per patient:\")\n", + "print(trials_per_patient.value_counts().sort_index())\n", + "\n", + "# Identify patients with the most and least trials\n", + "max_trials = trials_per_patient.max()\n", + "min_trials = trials_per_patient.min()\n", + "\n", + "# Display patients with the maximum number of trials\n", + "print(f\"\\nPatients with the most trials ({max_trials}):\")\n", + "print(trials_per_patient[trials_per_patient == max_trials].index.tolist())\n", + "\n", + "# Display patients with the minimum number of trials\n", + "print(f\"\\nPatients with the least trials ({min_trials}):\")\n", + "print(trials_per_patient[trials_per_patient == min_trials].index.tolist())\n", + "\n", + "# Add the number of trials for each patient back to df_final\n", + "df_final['num_trials'] = df_final['patient_id'].map(trials_per_patient)\n", + "\n", + "# Count the number of distinct criteria texts for each patient\n", + "criteria_per_patient = df_final.groupby('patient_id')['criterion_text'].nunique().sort_values(ascending=False)\n", + "\n", + "# Display basic statistics of the number of distinct criteria per patient\n", + "print(\"Statistics of distinct criteria per patient:\")\n", + "print(criteria_per_patient.describe())\n", + "\n", + "# Display the distribution of distinct criteria per patient\n", + "print(\"\\nDistribution of distinct criteria per patient:\")\n", + "print(criteria_per_patient.value_counts().sort_index())\n", + "\n", + "# Calculate and display the percentage distribution of distinct criteria per patient\n", + "percentage_distribution = (criteria_per_patient.value_counts().sort_index() / len(criteria_per_patient)) * 100\n", + "print(\"\\nPercentage distribution of distinct criteria per patient:\")\n", + "print(percentage_distribution)\n", + "\n", + "# Visualize the distribution of distinct criteria per patient\n", + "plt.figure(figsize=(12, 6))\n", + "sns.histplot(criteria_per_patient, kde=True, bins=30)\n", + "plt.title('Distribution of Distinct Criteria per Patient')\n", + "plt.xlabel('Number of Distinct Criteria')\n", + "plt.ylabel('Number of Patients')\n", + "# plt.savefig('criteria_per_patient_distribution.png')\n", + "# plt.close()\n", + "print(\"\\nDistribution plot saved as 'criteria_per_patient_distribution.png'\")" + ] + }, + { + "cell_type": "code", + "execution_count": 16, + "id": "1f663543-d6e3-4535-bab4-d5c135217929", + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "\n", + "Summary of distinct criteria per patient:\n", + " num_criteria num_patients percentage\n", + "0 4 1 1.923077\n", + ".. ... ... ...\n", + "\n", + "[27 rows x 3 columns]\n", + "\n", + "Patients with the most distinct criteria (43):\n", + "['sigir-20144']\n", + "\n", + "Patients with the least distinct criteria (4):\n", + "['sigir-20149']\n", + "\n", + "First few rows of df_final with num_distinct_criteria added:\n", + " patient_id \\\n", + "0 sigir-20141 \n", + ".. ... \n", + "\n", + " text \\\n", + "0 A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is ... \n", + ".. ... \n", + "\n", + " trial_id score annotation_id \\\n", + "0 NCT01397994 1 0 \n", + ".. ... ... ... \n", + "\n", + " note \\\n", + "0 0. A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life.\\n1. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, ... \n", + ".. ... \n", + "\n", + " trial_title \\\n", + "0 Study to Assess Efficacy of Nicorandil+Atenolol vs Atenolol in Treatment of Chronic Stable Angina. \n", + ".. ... \n", + "\n", + " criterion_type \\\n", + "0 inclusion \n", + ".. ... \n", + "\n", + " criterion_text \\\n", + "0 Patients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. \n", + ".. ... \n", + "\n", + " gpt4_explanation \\\n", + "0 The patient note does not provide direct evidence of the patient having chronic stable angina or having undergone an Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. However, the patient does present with symptoms of chest pain, which could be i... \n", + ".. ... \n", + "\n", + " explanation_correctness gpt4_sentences expert_sentences \\\n", + "0 Correct [0, 1, 2] [0, 1, 2] \n", + ".. ... ... ... \n", + "\n", + " gpt4_eligibility expert_eligibility training num_trials \\\n", + "0 not enough information not enough information True 2 \n", + ".. ... ... ... ... \n", + "\n", + " num_distinct_criteria \n", + "0 31 \n", + ".. ... \n", + "\n", + "[5 rows x 18 columns]\n", + "\n", + "Top 10 most common criteria texts:\n", + "criterion_text\n", + "Pregnancy 3\n", + " ..\n", + "Name: count, Length: 10, dtype: int64\n" + ] + } + ], + "source": [ + "# Create a summary DataFrame\n", + "summary_df = pd.DataFrame({\n", + " 'num_criteria': criteria_per_patient.value_counts().sort_index().index,\n", + " 'num_patients': criteria_per_patient.value_counts().sort_index().values,\n", + " 'percentage': percentage_distribution.values\n", + "})\n", + "\n", + "# Display the summary DataFrame\n", + "print(\"\\nSummary of distinct criteria per patient:\")\n", + "print(summary_df)\n", + "\n", + "# # Save the summary to a CSV file\n", + "# summary_df.to_csv('criteria_per_patient_summary.csv', index=False)\n", + "# print(\"\\nSummary saved to 'criteria_per_patient_summary.csv'\")\n", + "\n", + "# Identify patients with the most and least distinct criteria\n", + "max_criteria = criteria_per_patient.max()\n", + "min_criteria = criteria_per_patient.min()\n", + "\n", + "print(f\"\\nPatients with the most distinct criteria ({max_criteria}):\")\n", + "print(criteria_per_patient[criteria_per_patient == max_criteria].index.tolist())\n", + "\n", + "print(f\"\\nPatients with the least distinct criteria ({min_criteria}):\")\n", + "print(criteria_per_patient[criteria_per_patient == min_criteria].index.tolist())\n", + "\n", + "# Optional: If you want to add this information back to df_final\n", + "df_final['num_distinct_criteria'] = df_final['patient_id'].map(criteria_per_patient)\n", + "\n", + "# Display the first few rows of the updated df_final\n", + "print(\"\\nFirst few rows of df_final with num_distinct_criteria added:\")\n", + "print(df_final.head())\n", + "\n", + "# # Save the updated df_final\n", + "# df_final.to_csv('df_final_with_criteria_counts.csv', index=False)\n", + "# print(\"\\nUpdated df_final saved to 'df_final_with_criteria_counts.csv'\")\n", + "\n", + "# Additional analysis: Most common criteria texts\n", + "top_criteria = df_final['criterion_text'].value_counts().head(10)\n", + "print(\"\\nTop 10 most common criteria texts:\")\n", + "print(top_criteria)" + ] + }, + { + "cell_type": "code", + "execution_count": 17, + "id": "c7c66f15-c251-4b4b-99c6-ad35f5f0ce0d", + "metadata": {}, + "outputs": [ + { + "data": { + "text/html": [ + "
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0sigir-20141A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is ...NCT01397994100. A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life.\\n1. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, ...Study to Assess Efficacy of Nicorandil+Atenolol vs Atenolol in Treatment of Chronic Stable Angina.inclusionPatients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes.The patient note does not provide direct evidence of the patient having chronic stable angina or having undergone an Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. However, the patient does present with symptoms of chest pain, which could be i...Correct[0, 1, 2][0, 1, 2]not enough informationnot enough informationTrue231
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" + ], + "text/plain": [ + " patient_id \\\n", + "0 sigir-20141 \n", + ".. ... \n", + "\n", + " text \\\n", + "0 A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is ... \n", + ".. ... \n", + "\n", + " trial_id score annotation_id \\\n", + "0 NCT01397994 1 0 \n", + ".. ... ... ... \n", + "\n", + " note \\\n", + "0 0. A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life.\\n1. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, ... \n", + ".. ... \n", + "\n", + " trial_title \\\n", + "0 Study to Assess Efficacy of Nicorandil+Atenolol vs Atenolol in Treatment of Chronic Stable Angina. \n", + ".. ... \n", + "\n", + " criterion_type \\\n", + "0 inclusion \n", + ".. ... \n", + "\n", + " criterion_text \\\n", + "0 Patients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. \n", + ".. ... \n", + "\n", + " gpt4_explanation \\\n", + "0 The patient note does not provide direct evidence of the patient having chronic stable angina or having undergone an Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. However, the patient does present with symptoms of chest pain, which could be i... \n", + ".. ... \n", + "\n", + " explanation_correctness gpt4_sentences expert_sentences \\\n", + "0 Correct [0, 1, 2] [0, 1, 2] \n", + ".. ... ... ... \n", + "\n", + " gpt4_eligibility expert_eligibility training num_trials \\\n", + "0 not enough information not enough information True 2 \n", + ".. ... ... ... ... \n", + "\n", + " num_distinct_criteria \n", + "0 31 \n", + ".. ... \n", + "\n", + "[997 rows x 18 columns]" + ] + }, + "execution_count": 17, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "df_final" + ] + }, + { + "cell_type": "code", + "execution_count": 18, + "id": "47d447be-d7e4-4e9c-8467-5e8badad5f6a", + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "Number of patients meeting the criteria: 21\n", + "\n", + "Randomly selected patient_ids:\n", + "1. patient_id: sigir-20158\n", + " num_trials: 2\n", + " num_distinct_criteria: 22\n", + "\n", + "2. patient_id: sigir-20147\n", + " num_trials: 2\n", + " num_distinct_criteria: 17\n", + "\n", + "3. patient_id: sigir-20153\n", + " num_trials: 2\n", + " num_distinct_criteria: 16\n", + "\n", + "4. patient_id: sigir-201510\n", + " num_trials: 2\n", + " num_distinct_criteria: 15\n", + "\n", + "5. patient_id: sigir-201411\n", + " num_trials: 2\n", + " num_distinct_criteria: 15\n", + "\n", + "Total number of queries: 59\n", + "Number of queries after filtering: 5\n", + "Number of queries removed: 54\n", + "\n", + "Filtered queries saved to dataset/sigir/mini_filtered_queries.jsonl\n", + "\n", + "Number of queries in the JSONL file: 5\n" + ] + } + ], + "source": [ + "# Filter the DataFrame to select patients with exactly 2 trials and between 15-25 distinct criteria\n", + "filtered_df = df_final[\n", + " (df_final['num_trials'] == 2) & \n", + " (df_final['num_distinct_criteria'].between(15, 25))\n", + "].drop_duplicates('patient_id')\n", + "\n", + "# Count how many patients meet these criteria\n", + "num_matching_patients = filtered_df['patient_id'].nunique()\n", + "print(f\"Number of patients meeting the criteria: {num_matching_patients}\")\n", + "\n", + "sampsto = 5 # Number of patients to sample\n", + "\n", + "# If we have at least 'sampsto' patients meeting the criteria, randomly select that many\n", + "if num_matching_patients >= sampsto:\n", + " # Randomly select 'sampsto' patients\n", + " selected_patients = random.sample(filtered_df['patient_id'].unique().tolist(), sampsto)\n", + " \n", + " # Print details of the selected patients\n", + " print(\"\\nRandomly selected patient_ids:\")\n", + " for i, patient_id in enumerate(selected_patients, 1):\n", + " patient_data = filtered_df[filtered_df['patient_id'] == patient_id].iloc[0]\n", + " print(f\"{i}. patient_id: {patient_id}\")\n", + " print(f\" num_trials: {patient_data['num_trials']}\")\n", + " print(f\" num_distinct_criteria: {patient_data['num_distinct_criteria']}\")\n", + " print()\n", + "\n", + " # Create a new DataFrame with all data for these selected patients\n", + " selected_df = df_final[df_final['patient_id'].isin(selected_patients)]\n", + "\n", + "else:\n", + " print(\"Not enough patients meet the criteria. Please adjust the filter conditions.\")\n", + "\n", + "# Filter df_queries to keep only the _ids present in selected_df's patient_id\n", + "df_queries_filtered = df_queries[df_queries['_id'].isin(selected_df['patient_id'])]\n", + "\n", + "# Display information about the filtering process\n", + "print(f\"Total number of queries: {len(df_queries)}\")\n", + "print(f\"Number of queries after filtering: {len(df_queries_filtered)}\")\n", + "print(f\"Number of queries removed: {len(df_queries) - len(df_queries_filtered)}\")\n", + "\n", + "# Save filtered queries to a new JSONL file\n", + "output_file = 'dataset/sigir/mini_filtered_queries.jsonl'\n", + "with open(output_file, 'w') as file:\n", + " for _, row in df_queries_filtered.iterrows():\n", + " json.dump(row.to_dict(), file)\n", + " file.write('\\n')\n", + "print(f\"\\nFiltered queries saved to {output_file}\")\n", + "\n", + "# Verify the number of queries in the saved file\n", + "print(f\"\\nNumber of queries in the JSONL file: {sum(1 for line in open(output_file))}\")\n", + "\n", + "\n", + "# 1. Patient Selection:\n", + "# - Filters patients based on specific criteria (2 trials and 15-25 distinct criteria).\n", + "# - Randomly selects a subset of these patients for further analysis.\n", + "\n", + "# 2. Data Extraction:\n", + "# - Creates a new DataFrame (selected_df) containing all data for the selected patients.\n", + "\n", + "# 3. Query Filtering:\n", + "# - Filters the original queries dataset to include only the selected patients.\n", + "\n", + "# 4. Data Saving:\n", + "# - Saves the filtered queries to a new JSONL file.\n", + "\n", + "# 5. Verification:\n", + "# - Checks the number of queries in the saved file to ensure data integrity.\n", + "\n", + "# This process is crucial for several reasons:\n", + "# - It creates a manageable subset of data for detailed analysis or testing.\n", + "# - The selection criteria ensure that the chosen patients have a similar level of complexity (in terms of trials and criteria), which can be important for fair comparisons or model testing.\n", + "# - Saving this subset as a separate file allows for easier replication of analyses or tests.\n", + "# - The random selection helps to avoid bias that might come from manually selecting patients.\n", + "\n", + "# The verification steps throughout (counting patients, queries, etc.) are essential for ensuring that the data manipulation processes have worked as expected and that the resulting dataset matches our intentions.\n", + "\n", + "# This approach of creating a smaller, well-defined subset of the data is often used in machine learning and data analysis to create test sets, perform detailed case studies, or to create manageable datasets for initial model development and testing." + ] + }, + { + "cell_type": "code", + "execution_count": 19, + "id": "bffd1b2b-ae7f-4f42-9493-22fb02921350", + "metadata": {}, + "outputs": [ + { + "data": { + "text/html": [ + "
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0NCT00995306Evaluating the Safety and Efficacy Civamide in Osteoarthritis (OA) of the Knee(s)Summary: To evaluate the safety and efficacy of Civamide Cream 0.075% as a treatment of the signs and symptoms associated with osteoarthritis of the knee.\\nInclusion criteria: inclusion criteria: \\n\\n Subject voluntarily agrees to participate in this study and signs an IRB-approved informed cons...{'brief_title': 'Evaluating the Safety and Efficacy Civamide in Osteoarthritis (OA) of the Knee(s)', 'phase': 'Phase 3', 'drugs': '['Civamide (Zucapsaicin)']', 'drugs_list': ['Civamide (Zucapsaicin)'], 'diseases': '['Osteoarthritis of the Knee']', 'diseases_list': ['Osteoarthritis of the Knee'],...
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" + ], + "text/plain": [ + " _id \\\n", + "0 NCT00995306 \n", + ".. ... \n", + "\n", + " title \\\n", + "0 Evaluating the Safety and Efficacy Civamide in Osteoarthritis (OA) of the Knee(s) \n", + ".. ... \n", + "\n", + " text \\\n", + "0 Summary: To evaluate the safety and efficacy of Civamide Cream 0.075% as a treatment of the signs and symptoms associated with osteoarthritis of the knee.\\nInclusion criteria: inclusion criteria: \\n\\n Subject voluntarily agrees to participate in this study and signs an IRB-approved informed cons... \n", + ".. ... \n", + "\n", + " metadata \n", + "0 {'brief_title': 'Evaluating the Safety and Efficacy Civamide in Osteoarthritis (OA) of the Knee(s)', 'phase': 'Phase 3', 'drugs': '['Civamide (Zucapsaicin)']', 'drugs_list': ['Civamide (Zucapsaicin)'], 'diseases': '['Osteoarthritis of the Knee']', 'diseases_list': ['Osteoarthritis of the Knee'],... \n", + ".. ... \n", + "\n", + "[3621 rows x 4 columns]" + ] + }, + "execution_count": 19, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "# Read the corpus.jsonl file\n", + "# corpus.jsonl contains detailed information about clinical trials\n", + "# Each line in this file is a JSON object representing a single trial\n", + "# The structure includes fields like '_id' (trial ID), 'title', 'text', and 'metadata'\n", + "corpus_file = 'dataset/sigir/corpus.jsonl'\n", + "\n", + "# Use pandas to read the JSONL file\n", + "# The 'lines=True' parameter tells pandas to read the file as JSON Lines format\n", + "# where each line is a separate JSON object\n", + "df_corpus = pd.read_json(corpus_file, lines=True)\n", + "\n", + "# Display the entire DataFrame\n", + "df_corpus\n", + "\n", + "# Note on corpus.jsonl structure:\n", + "# Each entry in corpus.jsonl looks like this:\n", + "# {\n", + "# \"_id\": \"NCT01520155\",\n", + "# \"title\": \"CArdiovascular Risk Assessment STudy in Lupus Erythemathodes (CASTLE)\",\n", + "# \"text\": \"Summary: The key of this prospective study is to identify...\",\n", + "# \"metadata\": {\n", + "# \"brief_title\": \"CArdiovascular Risk Assessment STudy in Lupus Erythemathodes (CASTLE)\",\n", + "# \"phase\": \"\",\n", + "# \"drugs\": \"\",\n", + "# \"drugs_list\": [],\n", + "# \"diseases\": \"['Systemic Lupus Erythematosus']\",\n", + "# \"diseases_list\": [\"Systemic Lupus Erythematosus\"],\n", + "# \"enrollment\": \"90.0\",\n", + "# \"inclusion_criteria\": \"inclusion criteria: \\n\\n Patients with systemic Lupus erythematosus \\n\\n \",\n", + "# \"exclusion_criteria\": \": \\n\\n Patients without systemic Lupus erythematosus\",\n", + "# \"brief_summary\": \"The key of this prospective study is to identify...\"\n", + "# }\n", + "# }" + ] + }, + { + "cell_type": "code", + "execution_count": 20, + "id": "81c0509e-c8ec-45fa-8f99-a88d1e5febf4", + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "Filtered corpus saved to dataset/sigir/corpus_mini.jsonl\n" + ] + } + ], + "source": [ + "\n", + "# Filter the corpus to include only the trials present in df_final\n", + "# This step ensures we only keep trials that are relevant to our analysis\n", + "df_corpus_filtered = df_corpus[df_corpus['_id'].isin(df_final['trial_id'])]\n", + "\n", + "# Display the filtered corpus DataFrame\n", + "df_corpus_filtered\n", + "\n", + "# Save the filtered corpus to 'corpus_mini.jsonl'\n", + "# This creates a smaller, focused dataset for further analysis\n", + "output_file = 'dataset/sigir/corpus_mini.jsonl'\n", + "df_corpus_filtered.to_json(output_file, orient='records', lines=True)\n", + "\n", + "print(f\"Filtered corpus saved to {output_file}\")\n", + "\n", + "\n", + "# Why this filtering is safe and prevents unnecessary calculation:\n", + "\n", + "# 1. Data Relevance:\n", + "# - By filtering the corpus to include only trials present in df_final, we ensure that we're working with only the relevant trials for our analysis.\n", + "# - This aligns the corpus data with the TrialGPT-Criterion-Annotations dataset, maintaining consistency across our datasets.\n", + "\n", + "# 2. Computational Efficiency:\n", + "# - Reducing the size of the corpus eliminates the need to process trials that are not part of our analysis scope.\n", + "# - This can significantly reduce computation time and resource usage in subsequent steps, especially if the original corpus is large.\n", + "\n", + "# 3. Focus on Annotated Data:\n", + "# - By keeping only the trials that correspond to the TrialGPT-Criterion-Annotations dataset, we ensure that all trials in our filtered corpus have associated annotations.\n", + "# - This alignment is crucial for accurate analysis and model training, as we have expert-annotated data for these trials.\n", + "\n", + "# 4. Preventing Noise:\n", + "# - Removing trials not present in the annotation dataset eliminates potential noise or irrelevant data that could skew our analysis or model performance.\n", + "\n", + "# 5. Consistency in Replication:\n", + "# - This filtering step ensures that we're working with the exact set of trials that were part of the original study's annotated dataset.\n", + "# - This is crucial for accurately replicating and validating the results of the original study.\n", + "\n", + "# 6. Storage Efficiency:\n", + "# - Saving a smaller, filtered corpus (corpus_mini.jsonl) reduces storage requirements and makes the dataset more manageable for sharing or further processing.\n", + "\n", + "# 7. Ethical Considerations:\n", + "# - By focusing only on trials with associated annotations, we're ensuring that all data used in our analysis has been properly vetted and annotated by experts.\n", + "\n", + "# 8. Reproducibility:\n", + "# - This filtered corpus, along with the other filtered datasets, creates a well-defined, reproducible dataset for your analysis.\n", + "\n", + "# In essence, this filtering step is not just safe but also highly beneficial. It streamlines your dataset, focuses on the most relevant information, and aligns perfectly with the annotated data you're working with. \n", + "# This approach ensures that your analysis is based on a consistent, well-defined set of trials, which is crucial for the integrity and reliability of your results in the clinical trial eligibility assessment task." + ] + }, + { + "cell_type": "raw", + "id": "28206a12-3a28-4e64-a72f-5de67abed8c6", + "metadata": {}, + "source": [ + "# filter pre made retrieved_trials to just those in annotation " + ] + }, + { + "cell_type": "raw", + "id": "58e727b2-af91-49ff-9a9c-ae68751a4f64", + "metadata": {}, + "source": [ + "# Read the JSON file containing pre-compiled retrieved trials\n", + "# This file is part of the original repo and represents their data\n", + "with open('dataset/sigir/retrieved_trials.json', 'r') as file:\n", + " data = json.load(file)\n", + "\n", + "# Create a set of filtered NCTIDs from our previously filtered corpus\n", + "# This set will be used to filter the retrieved trials\n", + "filtered_nctids = set(df_corpus_filtered['_id'].tolist())\n", + "\n", + "# Define a function to filter trials based on the filtered NCTIDs\n", + "def filter_trials(trials):\n", + " return [trial for trial in trials if trial['NCTID'] in filtered_nctids]\n", + "\n", + "# Filter the data while maintaining the original structure\n", + "filtered_data = []\n", + "for entry in data:\n", + " filtered_entry = entry.copy()\n", + " for key in ['0', '1', '2']: # These keys likely represent different retrieval methods or rankings\n", + " if key in filtered_entry:\n", + " filtered_entry[key] = filter_trials(filtered_entry[key])\n", + " \n", + " # Keep the entry even if all lists are empty to maintain patient records\n", + " filtered_data.append(filtered_entry)\n", + "\n", + "# Save the filtered data to a new JSON file\n", + "with open('dataset/sigir/retrieved_trials_mini.json', 'w') as file:\n", + " json.dump(filtered_data, file, indent=2)\n", + "\n", + "# Define a function to flatten the hierarchical data structure for easier processing\n", + "def flatten_data(entry):\n", + " flattened = []\n", + " for key in ['0', '1', '2']:\n", + " if key in entry and isinstance(entry[key], list):\n", + " for item in entry[key]:\n", + " item['patient_id'] = entry['patient_id']\n", + " item['patient'] = entry['patient']\n", + " flattened.append(item)\n", + " return flattened\n", + "\n", + "# Flatten the filtered data and convert it to a DataFrame for further analysis\n", + "flattened_data = [item for entry in filtered_data for item in flatten_data(entry)]\n", + "df_filtered = pd.DataFrame(flattened_data)\n", + "df_filtered\n", + "\n", + "# This code block is crucial for several reasons:\n", + "\n", + "# 1. Data Alignment: It aligns the pre-compiled retrieved trials from the original repository with our filtered dataset, ensuring we're working with a consistent set of trials.\n", + "\n", + "# 2. Focused Analysis: By filtering the retrieved trials to include only those with annotations, we're creating a direct comparison set that should match their test set. This is essential for validating their results and understanding their methodology.\n", + "\n", + "# 3. Structural Preservation: The code maintains the original structure of the data (with keys '0', '1', '2'), which likely represent different retrieval methods or ranking systems used in the original study.\n", + "\n", + "# 4. Comprehensive Comparison: By keeping entries even if all lists are empty, we maintain a record of all patients, allowing us to identify any discrepancies or gaps in the retrieval process.\n", + "\n", + "# 5. Data Transformation: The flattening process transforms the hierarchical JSON structure into a tabular format (DataFrame), making it easier to perform detailed analyses and comparisons.\n", + "\n", + "# 6. Reproducibility: This step is crucial for reproducing and validating the original study's results. By using their pre-compiled data and filtering it to match our annotated set, we're creating a fair basis for comparison.\n", + "\n", + "# 7. Insight into Methodology: This process might reveal insights into how the original study selected or processed their test set, which could be valuable for understanding their approach and results.\n", + "\n", + "# The significance of this step cannot be overstated. It allows us to:\n", + "# - Directly compare our results with theirs using the same set of trials.\n", + "# - Identify any discrepancies between the retrieved trials and the annotated set.\n", + "# - Potentially uncover reasons for any performance differences we might observe.\n", + "# - Ensure that our evaluation is based on the same foundation as the original study, making our comparisons and conclusions more robust and valid.\n" + ] + }, + { + "cell_type": "code", + "execution_count": 22, + "id": "94c470e9-fd03-4606-8c2c-5675548da3a6", + "metadata": { + "scrolled": true + }, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "Total entries in filtered data: 52\n", + "Total flattened rows: 103\n", + "Unique patient_ids: 52\n", + "Unique NCTIDs: 101\n" + ] + }, + { + "data": { + "text/plain": [ + "103" + ] + }, + "execution_count": 22, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "# for the new one filter an include all \n", + "### after \n", + "# Step 1 completed at 2025-01-26 20:54:55 (Duration: 197s)\n", + "# Step 2 completed at 2025-01-26 20:58:10 (Duration: 5s)\n", + "\n", + "# This code is executed after Steps 1 and 2 in the new project(comprehensive overhaul)\n", + "# It filters and processes the retrieved trials to match the annotated dataset\n", + "\n", + "# Read the JSON file containing retrieved trials from the new project\n", + "with open('results/retrieved_trials.json', 'r') as file:\n", + " data = json.load(file)\n", + "\n", + "# Create a set of valid (patient_id, trial_id) combinations from df_joined\n", + "# This ensures we only keep trials that have annotations in our dataset\n", + "valid_combinations = set(df_joined[['patient_id', 'trial_id']].itertuples(index=False, name=None))\n", + "\n", + "# Function to filter trials based on patient_id and valid combinations\n", + "def filter_trials(trials, patient_id):\n", + " return [trial for trial in trials if (patient_id, trial['NCTID']) in valid_combinations]\n", + "\n", + "# Filter the data while maintaining the original structure\n", + "filtered_data = []\n", + "for entry in data:\n", + " filtered_entry = entry.copy()\n", + " patient_id = entry['patient_id']\n", + " for key in ['0', '1', '2']: # These likely represent different retrieval methods or rankings\n", + " if key in filtered_entry:\n", + " filtered_entry[key] = filter_trials(filtered_entry[key], patient_id)\n", + " \n", + " # Keep the entry even if all lists are empty to maintain patient records\n", + " filtered_data.append(filtered_entry)\n", + "\n", + "# Save the filtered data back to the same JSON file\n", + "with open('results/retrieved_trials.json', 'w') as file:\n", + " json.dump(filtered_data, file, indent=2)\n", + "\n", + "# Function to flatten the hierarchical data structure for easier processing\n", + "def flatten_data(entry):\n", + " flattened = []\n", + " for key in ['0', '1', '2']:\n", + " if key in entry and isinstance(entry[key], list):\n", + " for item in entry[key]:\n", + " item['patient_id'] = entry['patient_id']\n", + " item['patient'] = entry['patient']\n", + " flattened.append(item)\n", + " return flattened\n", + "\n", + "# Flatten the filtered data and convert it to a DataFrame for further analysis\n", + "flattened_data = [item for entry in filtered_data for item in flatten_data(entry)]\n", + "df_filtered = pd.DataFrame(flattened_data)\n", + "\n", + "# Print statistics about the filtered and flattened data\n", + "print(f\"Total entries in filtered data: {len(filtered_data)}\")\n", + "print(f\"Total flattened rows: {len(df_filtered)}\")\n", + "print(f\"Unique patient_ids: {df_filtered['patient_id'].nunique()}\")\n", + "print(f\"Unique NCTIDs: {df_filtered['NCTID'].nunique()}\")\n", + "\n", + "# Display the total number of rows in the filtered DataFrame\n", + "len(df_filtered)\n", + "\n", + "# Note: This filtering allows for setting TOP_K=100 in processing\n", + "# With 101 trials in corpus_mini.jsonl, this approach ensures all annotated cases are included\n", + "# while significantly reducing the number of results to process (from potential 52k to a more manageable subset)\n", + "\n", + "# 1. Data Alignment: It aligns the retrieved trials from your new project with the annotated dataset, ensuring consistency and relevance.\n", + "# 2. Efficiency: By filtering the retrieved trials to match only the annotated cases, you're significantly reducing the computational load for subsequent steps.\n", + "# 3. Comprehensive Coverage: This approach ensures that all annotated cases are included in the analysis, providing a complete picture of the annotated dataset.\n", + "# 4. Flexibility: Setting TOP_K=100 allows for a thorough analysis of retrieved trials per patient while keeping the dataset manageable.\n", + "# 5. Reproducibility: This filtering step creates a well-defined subset of data that can be consistently used across different analyses or model runs.\n", + "# 6. Performance Optimization: By reducing the dataset from a potential 52k results to a more focused subset, you're optimizing for both performance and relevance.\n", + "# 7. Quality Control: This process helps in identifying any discrepancies between retrieved trials and annotated data, which is crucial for maintaining data quality.\n", + "# 8. Scalability: While currently working with 101 trials, this approach scales well if you decide to expand the corpus in the future.\n" + ] + }, + { + "cell_type": "markdown", + "id": "f72a5ccb-11cb-4912-9fdf-424b7c370100", + "metadata": {}, + "source": [ + "# up to here to filter dataset to just annotated data trials" + ] + }, + { + "cell_type": "code", + "execution_count": 23, + "id": "40481a95-f456-4a30-a605-97e88db2b42a", + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "\n", + "Total number of rows: 103\n", + "Number of unique patients: 52\n", + "Number of unique trials: 101\n" + ] + }, + { + "data": { + "text/html": [ + "
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patient_idpatient_summarytrial_idmatching_scoreagg_scoretrial_scoreqrels_scorebrief_summaryrelevance_explanationeligibility_explanation
0sigir-20141A 58-year-old African-American woman presents with episodic anterior chest pain radiating to the back, accompanied by nausea, diaphoresis, and mild dyspnea. She has a history of hypertension and obesity but denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. The...NCT001492271.00.81.82The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients in Japan with hypertension in terms of the morbidity and mortality.The patient is relevant to the clinical trial as she has a clinical diagnosis of hypertension, which is a target condition of the trial. Additionally, she has obesity and ECG abnormalities, which are considered risk factors for the trial. These factors align with the trial's focus on high-risk p...The patient meets the inclusion criteria due to her hypertension and additional risk factors such as obesity and ECG abnormalities. She is not excluded by any of the exclusion criteria, as there is no evidence of ARB use, recent PCI or CABG, severe hypertension, pregnancy, arrhythmia, or severe ...
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" + ], + "text/plain": [ + " patient_id \\\n", + "0 sigir-20141 \n", + ".. ... \n", + "\n", + " patient_summary \\\n", + "0 A 58-year-old African-American woman presents with episodic anterior chest pain radiating to the back, accompanied by nausea, diaphoresis, and mild dyspnea. She has a history of hypertension and obesity but denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. The... \n", + ".. ... \n", + "\n", + " trial_id matching_score agg_score trial_score qrels_score \\\n", + "0 NCT00149227 1.0 0.8 1.8 2 \n", + ".. ... ... ... ... ... \n", + "\n", + " brief_summary \\\n", + "0 The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients in Japan with hypertension in terms of the morbidity and mortality. \n", + ".. ... \n", + "\n", + " relevance_explanation \\\n", + "0 The patient is relevant to the clinical trial as she has a clinical diagnosis of hypertension, which is a target condition of the trial. Additionally, she has obesity and ECG abnormalities, which are considered risk factors for the trial. These factors align with the trial's focus on high-risk p... \n", + ".. ... \n", + "\n", + " eligibility_explanation \n", + "0 The patient meets the inclusion criteria due to her hypertension and additional risk factors such as obesity and ECG abnormalities. She is not excluded by any of the exclusion criteria, as there is no evidence of ARB use, recent PCI or CABG, severe hypertension, pregnancy, arrhythmia, or severe ... \n", + ".. ... \n", + "\n", + "[5 rows x 10 columns]" + ] + }, + "execution_count": 23, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "# Define the directory containing the results to be analyzed\n", + "# Uncomment the appropriate line based on which results set you're working with\n", + "# results_to_workwith = 'TrialGPT/results_gpt4o'\n", + "# results_to_workwith = 'TrialGPT/results_gpt4o_perf103'\n", + "results_to_workwith = 'results'\n", + "# results_to_workwith = 'TrialGPT_working_raw/TrialGPT/results'\n", + "\n", + "# Read the JSON file containing all rankings data\n", + "with open(f'{results_to_workwith}/trial_rankings/all_rankings.json', 'r') as f:\n", + " data = json.load(f)\n", + "\n", + "# Prepare a list to store the flattened data\n", + "rows = []\n", + "\n", + "# Iterate through each patient in the data\n", + "for patient_id, patient_data in data.items():\n", + " patient_summary = patient_data['patient_summary']\n", + " \n", + " # Iterate through each trial for this patient\n", + " for trial_id, trial_data in patient_data['trials'].items():\n", + " # Create a dictionary for each patient-trial combination\n", + " row = {\n", + " 'patient_id': patient_id,\n", + " 'patient_summary': patient_summary,\n", + " 'trial_id': trial_id,\n", + " 'matching_score': trial_data['matching_score'],\n", + " 'agg_score': trial_data['agg_score'],\n", + " 'trial_score': trial_data['trial_score'],\n", + " 'qrels_score': trial_data['qrels_score'],\n", + " 'brief_summary': trial_data['brief_summary'],\n", + " 'relevance_explanation': trial_data['relevance_explanation'],\n", + " 'eligibility_explanation': trial_data['eligibility_explanation']\n", + " }\n", + " rows.append(row)\n", + "\n", + "# Create a DataFrame from the flattened data\n", + "all_rankings = pd.DataFrame(rows)\n", + "\n", + "# Optional: Save the DataFrame to a CSV file\n", + "# df.to_csv('flattened_trial_rankings.csv', index=False)\n", + "# print(\"\\nDataFrame saved to 'flattened_trial_rankings.csv'\")\n", + "\n", + "# Print summary statistics about the DataFrame\n", + "print(f\"\\nTotal number of rows: {len(all_rankings)}\")\n", + "print(f\"Number of unique patients: {all_rankings['patient_id'].nunique()}\")\n", + "print(f\"Number of unique trials: {all_rankings['trial_id'].nunique()}\")\n", + "\n", + "# Display the first few rows of the DataFrame\n", + "all_rankings.head()\n", + "\n", + "# 1. Data Source Selection: It allows flexibility in choosing which set of results to analyze by uncommenting the appropriate `results_to_workwith` line.\n", + "# 2. Data Loading: It reads the comprehensive rankings data from a JSON file, which likely contains the results of the trial matching process.\n", + "# 3. Data Flattening: The nested JSON structure is flattened into a list of dictionaries, each representing a patient-trial combination. This makes the data more suitable for tabular analysis.\n", + "# 4. Comprehensive Data Capture: For each patient-trial pair, it captures various scores (matching, aggregate, trial, and qrels scores) as well as summaries and explanations. This provides a rich dataset for analysis.\n", + "# 5. DataFrame Creation: By converting the flattened data into a pandas DataFrame, it enables powerful data manipulation and analysis capabilities.\n", + "# 7. Summary Statistics: It provides a quick overview of the dataset size and diversity by counting total rows, unique patients, and unique trials.\n", + "# 8. Data Preview: The `head()` function allows for a quick inspection of the first few rows of the DataFrame." + ] + }, + { + "cell_type": "code", + "execution_count": 24, + "id": "ea0ae4f5-021f-499d-be24-1a82b986cc36", + "metadata": {}, + "outputs": [ + { + "data": { + "text/html": [ + "
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patient_idtrial_idscorepatient_summarymatching_scoreagg_scoretrial_scoreqrels_scorebrief_summaryrelevance_explanationeligibility_explanation
0sigir-20141NCT001492271A 58-year-old African-American woman presents with episodic anterior chest pain radiating to the back, accompanied by nausea, diaphoresis, and mild dyspnea. She has a history of hypertension and obesity but denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. The...1.00.81.82The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients in Japan with hypertension in terms of the morbidity and mortality.The patient is relevant to the clinical trial as she has a clinical diagnosis of hypertension, which is a target condition of the trial. Additionally, she has obesity and ECG abnormalities, which are considered risk factors for the trial. These factors align with the trial's focus on high-risk p...The patient meets the inclusion criteria due to her hypertension and additional risk factors such as obesity and ECG abnormalities. She is not excluded by any of the exclusion criteria, as there is no evidence of ARB use, recent PCI or CABG, severe hypertension, pregnancy, arrhythmia, or severe ...
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" + ], + "text/plain": [ + " patient_id trial_id score \\\n", + "0 sigir-20141 NCT00149227 1 \n", + ".. ... ... ... \n", + "\n", + " patient_summary \\\n", + "0 A 58-year-old African-American woman presents with episodic anterior chest pain radiating to the back, accompanied by nausea, diaphoresis, and mild dyspnea. She has a history of hypertension and obesity but denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. The... \n", + ".. ... \n", + "\n", + " matching_score agg_score trial_score qrels_score \\\n", + "0 1.0 0.8 1.8 2 \n", + ".. ... ... ... ... \n", + "\n", + " brief_summary \\\n", + "0 The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients in Japan with hypertension in terms of the morbidity and mortality. \n", + ".. ... \n", + "\n", + " relevance_explanation \\\n", + "0 The patient is relevant to the clinical trial as she has a clinical diagnosis of hypertension, which is a target condition of the trial. Additionally, she has obesity and ECG abnormalities, which are considered risk factors for the trial. These factors align with the trial's focus on high-risk p... \n", + ".. ... \n", + "\n", + " eligibility_explanation \n", + "0 The patient meets the inclusion criteria due to her hypertension and additional risk factors such as obesity and ECG abnormalities. She is not excluded by any of the exclusion criteria, as there is no evidence of ARB use, recent PCI or CABG, severe hypertension, pregnancy, arrhythmia, or severe ... \n", + ".. ... \n", + "\n", + "[103 rows x 11 columns]" + ] + }, + "execution_count": 25, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "# Perform an inner join between df_tsv and all_rankings\n", + "# df_tsv contains the ground truth labels from 'TrialGPT/dataset/sigir/qrels/test.tsv'\n", + "# The labels in df_tsv represent:\n", + "# 2: Eligible - The patient is eligible to enroll in the trial\n", + "# 1: Excluded - The patient has the condition, but is ineligible due to exclusion criteria\n", + "# 0: Not Relevant - The patient is not relevant for the trial in any way\n", + "df_all_rankings_score = pd.merge(df_tsv, all_rankings, on=['patient_id', 'trial_id'], how='inner')\n", + "\n", + "# Display the number of rows in the resulting DataFrame\n", + "len(df_all_rankings_score)\n", + "\n", + "# Display the entire DataFrame\n", + "df_all_rankings_score\n", + "\n", + "\n", + "# 1. Ground Truth Integration: \n", + "# - It merges the ground truth labels (df_tsv) with the model's rankings and scores (all_rankings).\n", + "# - This integration is essential for evaluating the performance of your trial matching system.\n", + "\n", + "# 2. Label Context:\n", + "# - The labels from df_tsv provide a standardized assessment of patient eligibility for each trial.\n", + "# - Understanding these labels (2, 1, 0) is crucial for interpreting the results and evaluating the model's performance.\n", + "\n", + "# 3. Data Alignment:\n", + "# - The inner join ensures that we're only working with patient-trial pairs that have both ground truth labels and model predictions.\n", + "# - This alignment is necessary for fair and accurate evaluation.\n", + "\n", + "# 4. Comprehensive Analysis:\n", + "# - The resulting DataFrame (df_all_rankings_score) combines ground truth labels with various scores and explanations from the model.\n", + "# - This allows for a multi-faceted analysis of the model's performance, including accuracy, explanation quality, and potential biases.\n", + "\n", + "# 5. Performance Metrics:\n", + "# - With both true labels and predicted scores in one DataFrame, it's easier to calculate performance metrics like accuracy, precision, recall, and F1-score.\n", + "\n", + "# 6. Error Analysis:\n", + "# - This merged dataset facilitates detailed error analysis by allowing easy comparison between true labels and model predictions.\n", + "\n", + "# 7. Model Insight:\n", + "# - The inclusion of model-generated explanations alongside true labels can provide insights into why the model made certain predictions, especially in cases of disagreement with ground truth.\n", + "\n", + "# 8. Dataset Verification:\n", + "# - Displaying the length of the resulting DataFrame helps verify that the merge operation didn't unexpectedly lose or duplicate data.\n" + ] + }, + { + "cell_type": "code", + "execution_count": 26, + "id": "a206debf-510a-4b6f-84dd-4c438c37419a", + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "Unique values in 'score_mapped': ['Excluded' 'Eligible']\n", + "Unique values in 'qrels_score_mapped': ['Eligible' 'Excluded' 'Not Relevant']\n", + "\n", + "NaN values in 'score_mapped': 0\n", + "NaN values in 'qrels_score_mapped': 0\n" + ] + }, + { + "data": { + "image/png": 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+ "text/plain": [ + "
" + ] + }, + "metadata": {}, + "output_type": "display_data" + }, + { + "name": "stdout", + "output_type": "stream", + "text": [ + "\n", + "Classification Report:\n", + " precision recall f1-score support\n", + "\n", + " Eligible 0.57 0.51 0.54 49\n", + " Excluded 0.61 0.35 0.45 54\n", + "Not Relevant 0.00 0.00 0.00 0\n", + "\n", + " accuracy 0.43 103\n", + " macro avg 0.39 0.29 0.33 103\n", + "weighted avg 0.59 0.43 0.49 103\n", + "\n", + "\n", + "Overall F1 Score (weighted): 0.4901\n", + "\n", + "Actual Score Distribution:\n", + "score_mapped\n", + "Excluded 0.524272\n", + " ... \n", + "Name: proportion, Length: 2, dtype: float64\n", + "\n", + "Predicted Score Distribution:\n", + "qrels_score_mapped\n", + "Eligible 0.427184\n", + " ... \n", + "Name: proportion, Length: 3, dtype: float64\n" + ] + }, + { + "name": "stderr", + "output_type": "stream", + "text": [ + "/home/mikenet/.conda/envs/trialgpt_env/lib/python3.12/site-packages/sklearn/metrics/_classification.py:1531: UndefinedMetricWarning: Recall is ill-defined and being set to 0.0 in labels with no true samples. Use `zero_division` parameter to control this behavior.\n", + " _warn_prf(average, modifier, f\"{metric.capitalize()} is\", len(result))\n", + "/home/mikenet/.conda/envs/trialgpt_env/lib/python3.12/site-packages/sklearn/metrics/_classification.py:1531: UndefinedMetricWarning: Recall is ill-defined and being set to 0.0 in labels with no true samples. Use `zero_division` parameter to control this behavior.\n", + " _warn_prf(average, modifier, f\"{metric.capitalize()} is\", len(result))\n", + "/home/mikenet/.conda/envs/trialgpt_env/lib/python3.12/site-packages/sklearn/metrics/_classification.py:1531: UndefinedMetricWarning: Recall is ill-defined and being set to 0.0 in labels with no true samples. Use `zero_division` parameter to control this behavior.\n", + " _warn_prf(average, modifier, f\"{metric.capitalize()} is\", len(result))\n" + ] + } + ], + "source": [ + "# Convert 'score' and 'qrels_score' to string type for consistent mapping\n", + "df_all_rankings_score['score'] = df_all_rankings_score['score'].astype(str)\n", + "df_all_rankings_score['qrels_score'] = df_all_rankings_score['qrels_score'].astype(str)\n", + "\n", + "# Define the mapping from numeric scores to categorical labels\n", + "score_mapping = {\n", + " \"2\": \"Eligible\",\n", + " \"1\": \"Excluded\",\n", + " \"0\": \"Not Relevant\"\n", + "}\n", + "\n", + "# Apply the mapping to create new columns with categorical labels\n", + "df_all_rankings_score['score_mapped'] = df_all_rankings_score['score'].map(score_mapping)\n", + "df_all_rankings_score['qrels_score_mapped'] = df_all_rankings_score['qrels_score'].map(score_mapping)\n", + "\n", + "# Define the order of labels for consistent analysis\n", + "labels = [\"Not Relevant\", \"Excluded\", \"Eligible\"] # Ensure correct order\n", + "\n", + "# Print unique values to verify successful mapping\n", + "print(\"Unique values in 'score_mapped':\", df_all_rankings_score['score_mapped'].unique())\n", + "print(\"Unique values in 'qrels_score_mapped':\", df_all_rankings_score['qrels_score_mapped'].unique())\n", + "\n", + "# Check for NaN values which could indicate mapping issues\n", + "print(\"\\nNaN values in 'score_mapped':\", df_all_rankings_score['score_mapped'].isna().sum())\n", + "print(\"NaN values in 'qrels_score_mapped':\", df_all_rankings_score['qrels_score_mapped'].isna().sum())\n", + "\n", + "# Remove rows with NaN values to ensure clean data for analysis\n", + "df_clean = df_all_rankings_score.dropna(subset=['score_mapped', 'qrels_score_mapped'])\n", + "\n", + "# Generate the confusion matrix and performance metrics\n", + "try:\n", + " # Create confusion matrix\n", + " cm = confusion_matrix(df_clean['score_mapped'], df_clean['qrels_score_mapped'], labels=labels)\n", + " cm_df = pd.DataFrame(cm, index=labels, columns=labels)\n", + "\n", + " # Calculate F1 scores for each class\n", + " f1_scores = f1_score(df_clean['score_mapped'], df_clean['qrels_score_mapped'], average=None, labels=labels)\n", + " f1_df = pd.DataFrame({'Score Category': labels, 'F1 Score': f1_scores})\n", + "\n", + " # Plot confusion matrix and F1 scores\n", + " fig, (ax1, ax2) = plt.subplots(1, 2, figsize=(20, 8), gridspec_kw={'width_ratios': [3, 1]})\n", + "\n", + " # Confusion Matrix plot\n", + " sns.heatmap(cm_df, annot=True, fmt='d', cmap='Blues', ax=ax1)\n", + " ax1.set_title('Confusion Matrix: Actual vs. Predicted Scores')\n", + " ax1.set_ylabel('Actual Score')\n", + " ax1.set_xlabel('Predicted qrels_score')\n", + "\n", + " # F1 Scores plot\n", + " sns.barplot(x='F1 Score', y='Score Category', data=f1_df, ax=ax2, order=labels)\n", + " ax2.set_title('F1 Scores by Score Category')\n", + " ax2.set_xlabel('F1 Score')\n", + " ax2.set_ylabel('Score Category')\n", + "\n", + " plt.tight_layout()\n", + " plt.show()\n", + "\n", + " # Print detailed classification report\n", + " print(\"\\nClassification Report:\")\n", + " print(classification_report(df_clean['score_mapped'], df_clean['qrels_score_mapped']))\n", + "\n", + " # Calculate and print overall weighted F1 score\n", + " overall_f1 = f1_score(df_clean['score_mapped'], df_clean['qrels_score_mapped'], average='weighted')\n", + " print(f\"\\nOverall F1 Score (weighted): {overall_f1:.4f}\")\n", + "\n", + "except ValueError as e:\n", + " print(f\"An error occurred: {e}\")\n", + " print(\"Please check the unique values in both columns and ensure they match the expected labels.\")\n", + "\n", + "# Print label distribution for both actual and predicted scores\n", + "print(\"\\nActual Score Distribution:\")\n", + "print(df_clean['score_mapped'].value_counts(normalize=True))\n", + "print(\"\\nPredicted Score Distribution:\")\n", + "print(df_clean['qrels_score_mapped'].value_counts(normalize=True))\n", + "\n", + "\n", + "\n", + "\n", + "# 1. Data Preparation:\n", + "# - Converts scores to a consistent string format and maps them to meaningful categories.\n", + "# - Ensures data cleanliness by removing any rows with NaN values.\n", + "\n", + "# 2. Comprehensive Evaluation:\n", + "# - Generates a confusion matrix to visualize the model's performance across all categories.\n", + "# - Calculates F1 scores for each category, providing a balanced measure of precision and recall.\n", + "\n", + "# 3. Visualization:\n", + "# - Creates intuitive visualizations of the confusion matrix and F1 scores, making it easy to identify strengths and weaknesses in the model's performance.\n", + "\n", + "# 4. Detailed Reporting:\n", + "# - Prints a comprehensive classification report, including precision, recall, and F1-score for each category.\n", + "# - Calculates an overall weighted F1 score, giving a single metric for overall performance.\n", + "\n", + "# 5. Error Handling:\n", + "# - Includes try-except block to catch and report any issues with label mismatches or unexpected values.\n", + "\n", + "# 6. Distribution Analysis:\n", + "# - Compares the distribution of actual vs. predicted scores, which can reveal biases in the model's predictions.\n", + "\n", + "# This analysis provides a thorough evaluation of your clinical trial eligibility assessment model:\n", + "# - It allows you to see where the model performs well and where it struggles.\n", + "# - The confusion matrix helps identify common misclassifications.\n", + "# - F1 scores provide a balanced view of performance for each category.\n", + "# - The overall F1 score gives a single metric to track improvements over time.\n", + "# - Comparing actual and predicted distributions can reveal systemic biases in the model.\n", + "\n", + "\n", + "# 1. Classification Report:\n", + "\n", + "# Eligible:\n", + "# - Precision: 0.58 (58% of patients predicted as eligible were actually eligible)\n", + "# - Recall: 0.51 (51% of actually eligible patients were correctly identified)\n", + "# - F1-score: 0.54 (harmonic mean of precision and recall)\n", + "\n", + "# Excluded:\n", + "# - Precision: 0.59 (59% of patients predicted as excluded were actually excluded)\n", + "# - Recall: 0.37 (only 37% of actually excluded patients were correctly identified)\n", + "# - F1-score: 0.45 (lower than Eligible, indicating poorer performance)\n", + "\n", + "# Not Relevant:\n", + "# - All zeros, indicating that the model never predicted this category or there were no actual cases in this category\n", + "\n", + "# 2. Overall Metrics:\n", + "# - Accuracy: 0.44 (the model is correct only 44% of the time)\n", + "# - Weighted F1 Score: 0.4969 (less than 0.5, indicating poor overall performance)\n", + "\n", + "# 3. Distribution Comparison:\n", + "# Actual Distribution:\n", + "# - Excluded: 52.4%\n", + "# - Eligible: 47.6%\n", + "# - Not Relevant: 0%\n", + "\n", + "# Predicted Distribution:\n", + "# - Eligible: 41.7%\n", + "# - Excluded: 33.0%\n", + "# - Not Relevant: 25.2%\n", + "\n", + "# Interpretation:\n", + "# 1. Poor Overall Performance: The weighted F1 score of 0.4969 is quite low, suggesting that the model's performance is barely better than random guessing (which would be 0.33 for a three-class problem).\n", + "# 2. Imbalanced Predictions: The model is overpredicting \"Not Relevant\" cases (25.2%) when there are actually none in the true labels. This indicates a significant misalignment between the model's understanding and the actual data.\n", + "# 3. Low Recall for Excluded: The model is particularly bad at identifying excluded patients, catching only 37% of them. This could lead to inappropriately including patients in trials they should be excluded from, which is a serious issue in clinical settings.\n", + "# 4. Absence of \"Not Relevant\" in Actual Data: The actual data doesn't contain any \"Not Relevant\" cases, which is unusual and might indicate an issue with the dataset or the labeling process.\n", + "# 6. Clinical Implications: The poor performance, especially in distinguishing between eligible and excluded patients, could lead to serious issues in real-world application, potentially putting patients at risk or compromising trial integrity." + ] + }, + { + "cell_type": "raw", + "id": "52d9f288-2ce2-44bb-8a72-1016c4c8a244", + "metadata": {}, + "source": [ + "# new input here for classic " + ] + }, + { + "cell_type": "raw", + "id": "eabc9275-098c-46ee-9035-7de863b6b7b2", + "metadata": {}, + "source": [ + "# results_to_workwith = 'TrialGPT_working_wtf/TrialGPT/results_gpt4o' #TrialGPT_working_wtf/TrialGPT/results_gpt4o\n", + "# results_to_workwith = 'TrialGPT_working_wtf/TrialGPT/results'\n", + "# results_to_workwith = 'TrialGPT/results'\n", + "results_to_workwith = 'results'" + ] + }, + { + "cell_type": "code", + "execution_count": 27, + "id": "7b31cc5d-1563-470d-b48c-903040d6eccc", + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "\n", + "Number of rows excluded due to unexpected structure: 0\n", + "\n", + "RangeIndex: 1060 entries, 0 to 1059\n", + "Data columns (total 8 columns):\n", + " # Column Non-Null Count Dtype \n", + "--- ------ -------------- ----- \n", + " 0 patient_id 1060 non-null object\n", + " 1 TODOremove 1060 non-null object\n", + " 2 trial_id 1060 non-null object\n", + " 3 criterion_type 1060 non-null object\n", + " 4 criterion_number 1060 non-null object\n", + " 5 brief_reasoning 1060 non-null object\n", + " 6 sentence_ids 1060 non-null object\n", + " 7 eligibility_label 1060 non-null object\n", + "dtypes: object(8)\n", + "memory usage: 66.4+ KB\n", + "None\n", + "\n", + "Distribution of eligibility labels:\n", + "eligibility_label\n", + "not enough information 0.464151\n", + " ... \n", + "Name: proportion, Length: 6, dtype: float64\n", + "\n", + "Number of unique patients: 52\n", + "Number of unique trials: 101\n", + "\n", + "Average number of criteria per trial: 10.50\n", + "\n", + "Distribution of inclusion vs exclusion criteria:\n", + "criterion_type\n", + "exclusion 0.640566\n", + " ... \n", + "Name: proportion, Length: 2, dtype: float64\n" + ] + } + ], + "source": [ + "# Find the JSON file containing matching results\n", + "json_files = glob.glob(os.path.join(results_to_workwith, 'matching_results_*.json'))\n", + "\n", + "# Raise an error if no matching file is found\n", + "if not json_files:\n", + " raise FileNotFoundError(f\"No matching JSON file found in {results_to_workwith}\")\n", + "\n", + "# Use the first file found (assuming there's only one matching file)\n", + "json_file = json_files[0]\n", + "\n", + "# Load the JSON data\n", + "with open(json_file, 'r') as f:\n", + " data = json.load(f)\n", + "\n", + "# Prepare a list to store the flattened data\n", + "rows = []\n", + "\n", + "# Counter for excluded rows\n", + "excluded_count = 0\n", + "\n", + "# Iterate through each patient in the data\n", + "for patient_id, patient_data in data.items():\n", + " # Iterate through each trial for this patient\n", + " for trial_id, trial_data in patient_data.items():\n", + " # Iterate through each trial's data (NCT IDs)\n", + " for nct_id, nct_data in trial_data.items():\n", + " # Process both inclusion and exclusion criteria\n", + " for inc_exc in [\"inclusion\", \"exclusion\"]:\n", + " if isinstance(nct_data[inc_exc], dict):\n", + " for criterion_number, criterion_info in nct_data[inc_exc].items():\n", + " # Append flattened data to rows list\n", + " rows.append({\n", + " 'patient_id': patient_id,\n", + " 'TODOremove': trial_id,\n", + " 'trial_id': nct_id,\n", + " 'criterion_type': inc_exc,\n", + " 'criterion_number': criterion_number,\n", + " 'brief_reasoning': criterion_info[0] if isinstance(criterion_info, list) and len(criterion_info) > 0 else None,\n", + " 'sentence_ids': criterion_info[1] if isinstance(criterion_info, list) and len(criterion_info) > 1 else None,\n", + " 'eligibility_label': criterion_info[2] if isinstance(criterion_info, list) and len(criterion_info) > 2 else None\n", + " })\n", + " else:\n", + " excluded_count += 1\n", + " print(f\"Unexpected data structure for patient {patient_id}, trial {trial_id}, NCT {nct_id}, {inc_exc}\")\n", + "\n", + "# Create a DataFrame from the flattened data\n", + "df_matching_results = pd.DataFrame(rows)\n", + "\n", + "# Display the number of excluded rows\n", + "print(f\"\\nNumber of rows excluded due to unexpected structure: {excluded_count}\")\n", + "\n", + "# Display basic information about the DataFrame\n", + "print(df_matching_results.info())\n", + "\n", + "# Optional: Display the first few rows of the DataFrame\n", + "# print(df_matching_results.head())\n", + "\n", + "# Optional: Save to CSV\n", + "# df_matching_results.to_csv('flattened_matching_results.csv', index=False)\n", + "# print(\"DataFrame saved to 'flattened_matching_results.csv'\")\n", + "\n", + "# Display distribution of eligibility labels\n", + "print(\"\\nDistribution of eligibility labels:\")\n", + "print(df_matching_results['eligibility_label'].value_counts(normalize=True))\n", + "\n", + "# Display the number of unique patients and trials\n", + "print(f\"\\nNumber of unique patients: {df_matching_results['patient_id'].nunique()}\")\n", + "print(f\"Number of unique trials: {df_matching_results['trial_id'].nunique()}\")\n", + "\n", + "# Calculate and display the average number of criteria per trial\n", + "criteria_per_trial = df_matching_results.groupby('trial_id').size()\n", + "print(f\"\\nAverage number of criteria per trial: {criteria_per_trial.mean():.2f}\")\n", + "\n", + "# Display distribution of inclusion vs exclusion criteria\n", + "print(\"\\nDistribution of inclusion vs exclusion criteria:\")\n", + "print(df_matching_results['criterion_type'].value_counts(normalize=True))\n", + "\n", + "\n", + "\n", + "\n", + "# 1. Data Loading: It dynamically finds and loads the JSON file containing detailed matching results, which is essential for in-depth analysis of the model's performance.\n", + "# 2. Data Flattening: The nested JSON structure is flattened into a tabular format, making it easier to analyze using pandas.\n", + "# 3. Comprehensive Data Capture: For each patient-trial-criterion combination, it captures detailed information including the reasoning and eligibility label.\n", + "# 4. Flexibility: The code can handle multiple trials per patient and both inclusion and exclusion criteria.\n", + "# 5. Data Integrity Check: It provides summary statistics that help verify the integrity and structure of the data (e.g., number of unique patients and trials).\n", + "# 6. Performance Insights: The distribution of eligibility labels gives a quick overview of the model's decisions.\n", + "# 7. Dataset Characteristics: Information like average criteria per trial and distribution of inclusion vs exclusion criteria provides insights into the complexity of the eligibility assessment task.\n" + ] + }, + { + "cell_type": "code", + "execution_count": 28, + "id": "6c4779b9-6dfd-4925-83db-ef99dc922d79", + "metadata": {}, + "outputs": [ + { + "data": { + "text/html": [ + "
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patient_idTODOremovetrial_idcriterion_typecriterion_numberbrief_reasoningsentence_idseligibility_label
0sigir-201410NCT01397994inclusion0The patient has episodic chest pain but no evidence of chronic stable angina or abnormal Exercise Myocardial Perfusion Spect Scan.[0, 1]not included
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1060 rows × 8 columns

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" + ], + "text/plain": [ + " patient_id TODOremove trial_id criterion_type criterion_number \\\n", + "0 sigir-20141 0 NCT01397994 inclusion 0 \n", + ".. ... ... ... ... ... \n", + "\n", + " brief_reasoning \\\n", + "0 The patient has episodic chest pain but no evidence of chronic stable angina or abnormal Exercise Myocardial Perfusion Spect Scan. \n", + ".. ... \n", + "\n", + " sentence_ids eligibility_label \n", + "0 [0, 1] not included \n", + ".. ... ... \n", + "\n", + "[1060 rows x 8 columns]" + ] + }, + "execution_count": 28, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "df_matching_results" + ] + }, + { + "cell_type": "code", + "execution_count": 29, + "id": "3152ee4e-a6eb-4936-8368-b6bce2fabda8", + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "\n", + "RangeIndex: 1068 entries, 0 to 1067\n", + "Data columns (total 4 columns):\n", + " # Column Non-Null Count Dtype \n", + "--- ------ -------------- ----- \n", + " 0 trial_id 1068 non-null object\n", + " 1 criterion_type 1068 non-null object\n", + " 2 criterion_number 1068 non-null object\n", + " 3 criterion_text 1068 non-null object\n", + "dtypes: object(4)\n", + "memory usage: 33.5+ KB\n", + "None\n", + "\n", + "Number of unique trials: 101\n", + "\n", + "Average number of criteria per trial: 10.57\n", + "\n", + "Distribution of inclusion vs exclusion criteria:\n", + "criterion_type\n", + "exclusion 0.636704\n", + " ... \n", + "Name: proportion, Length: 2, dtype: float64\n" + ] + } + ], + "source": [ + "def parse_criteria(criteria: str) -> str:\n", + " \"\"\"\n", + " Parse and format a specific set of clinical trial criteria (either inclusion or exclusion).\n", + " This function cleans and numbers each criterion.\n", + " \"\"\"\n", + " output = \"\"\n", + " criteria_lines = criteria.split(\"\\n\")\n", + " idx = 0\n", + " for line in criteria_lines:\n", + " line = line.strip()\n", + " # Skip lines that are headers or too short\n", + " if \"inclusion criteria\" in line.lower() or \"exclusion criteria\" in line.lower():\n", + " continue\n", + " if len(line) < 5:\n", + " continue\n", + " # Add numbered criterion to output\n", + " output += f\"{idx}. {line}\\n\"\n", + " idx += 1\n", + " return output\n", + "\n", + "# Set the path to the corpus file\n", + "corpus_file = 'dataset/sigir/corpus.jsonl'\n", + "\n", + "# Prepare a list to store the flattened data\n", + "rows = []\n", + "\n", + "# Read and process the JSONL file\n", + "with open(corpus_file, 'r') as f:\n", + " for line in f:\n", + " trial_data = json.loads(line)\n", + " trial_id = trial_data['_id']\n", + " \n", + " # Process inclusion criteria\n", + " inclusion_criteria = parse_criteria(trial_data['metadata']['inclusion_criteria'])\n", + " for idx, criterion in enumerate(inclusion_criteria.strip().split('\\n')):\n", + " if criterion: # Skip empty lines\n", + " criterion_number, criterion_text = criterion.split('. ', 1)\n", + " rows.append({\n", + " 'trial_id': trial_id,\n", + " 'criterion_type': 'inclusion',\n", + " 'criterion_number': criterion_number,\n", + " 'criterion_text': criterion_text\n", + " })\n", + " \n", + " # Process exclusion criteria\n", + " exclusion_criteria = parse_criteria(trial_data['metadata']['exclusion_criteria'])\n", + " for idx, criterion in enumerate(exclusion_criteria.strip().split('\\n')):\n", + " if criterion: # Skip empty lines\n", + " criterion_number, criterion_text = criterion.split('. ', 1)\n", + " rows.append({\n", + " 'trial_id': trial_id,\n", + " 'criterion_type': 'exclusion',\n", + " 'criterion_number': criterion_number,\n", + " 'criterion_text': criterion_text\n", + " })\n", + "\n", + "# Create a DataFrame from the flattened data\n", + "df_corpus = pd.DataFrame(rows)\n", + "\n", + "# Display basic information about the DataFrame\n", + "print(df_corpus.info())\n", + "\n", + "# Optional: Display the first few rows of the DataFrame\n", + "# print(df_corpus.head())\n", + "\n", + "# Display the number of unique trials\n", + "print(f\"\\nNumber of unique trials: {df_corpus['trial_id'].nunique()}\")\n", + "\n", + "# Calculate and display the average number of criteria per trial\n", + "criteria_per_trial = df_corpus.groupby('trial_id').size()\n", + "print(f\"\\nAverage number of criteria per trial: {criteria_per_trial.mean():.2f}\")\n", + "\n", + "# Display distribution of inclusion vs exclusion criteria\n", + "print(\"\\nDistribution of inclusion vs exclusion criteria:\")\n", + "print(df_corpus['criterion_type'].value_counts(normalize=True))\n", + "\n", + "# Optional: Save to CSV\n", + "# df_corpus.to_csv('corpus_criteria.csv', index=False)\n", + "# print(\"DataFrame saved to 'corpus_criteria.csv'\")\n", + "\n", + "\n", + "# 1. Data Extraction: It extracts and structures the inclusion and exclusion criteria from the clinical trial corpus, which is essential for detailed analysis of trial eligibility requirements.\n", + "# 2. Data Cleaning: The `parse_criteria` function cleans and formats the criteria text, removing headers and short lines, and adding consistent numbering.\n", + "# 3. Standardization: By processing both inclusion and exclusion criteria in the same way, it creates a standardized format for all criteria across different trials.\n", + "# 4. Granular Data Structure: Each criterion is stored as a separate row, allowing for detailed analysis at the individual criterion level.\n", + "# 5. Data Integrity: The code maintains the association between criteria and their respective trials through the 'trial_id' field.\n", + "# 6. Comprehensive Coverage: It processes both inclusion and exclusion criteria, providing a complete picture of each trial's eligibility requirements.\n", + "# 7. Dataset Insights: The summary statistics (number of trials, average criteria per trial, distribution of inclusion vs exclusion criteria) provide valuable insights into the structure and complexity of the trial corpus.\n", + "\n", + "# The resulting `df_corpus` DataFrame serves as a comprehensive resource for understanding the landscape of clinical trial eligibility criteria in your dataset. This structured data is essential for developing and evaluating automated systems for trial matching and eligibility assessment." + ] + }, + { + "cell_type": "code", + "execution_count": 30, + "id": "f770f598-d819-4193-b44f-3a0b5d627711", + "metadata": {}, + "outputs": [ + { + "data": { + "text/html": [ + "
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trial_idcriterion_typecriterion_numbercriterion_text
0NCT01520155inclusion0Patients with systemic Lupus erythematosus
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1068 rows × 4 columns

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" + ], + "text/plain": [ + " trial_id criterion_type criterion_number \\\n", + "0 NCT01520155 inclusion 0 \n", + ".. ... ... ... \n", + "\n", + " criterion_text \n", + "0 Patients with systemic Lupus erythematosus \n", + ".. ... \n", + "\n", + "[1068 rows x 4 columns]" + ] + }, + "execution_count": 30, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "df_corpus" + ] + }, + { + "cell_type": "code", + "execution_count": 31, + "id": "f7efa96c-f819-4c59-b378-aeba2cda7b77", + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "\n", + "RangeIndex: 1060 entries, 0 to 1059\n", + "Data columns (total 9 columns):\n", + " # Column Non-Null Count Dtype \n", + "--- ------ -------------- ----- \n", + " 0 patient_id 1060 non-null object\n", + " 1 TODOremove 1060 non-null object\n", + " 2 trial_id 1060 non-null object\n", + " 3 criterion_type 1060 non-null object\n", + " 4 criterion_number 1060 non-null object\n", + " 5 brief_reasoning 1060 non-null object\n", + " 6 sentence_ids 1060 non-null object\n", + " 7 eligibility_label 1060 non-null object\n", + " 8 criterion_text 1058 non-null object\n", + "dtypes: object(9)\n", + "memory usage: 74.7+ KB\n", + "None\n", + "\n", + "Number of rows without matching criterion_text: 2\n", + "\n", + "Total rows: 1060\n", + "Matched rows: 1058\n", + "Match percentage: 99.81%\n", + "\n", + "Sample of unmatched rows:\n", + " trial_id criterion_type criterion_number \\\n", + "398 NCT00997100 inclusion 12 \n", + ".. ... ... ... \n", + "\n", + " brief_reasoning \n", + "398 The patient is willing and able to comply with the protocol. \n", + ".. ... \n", + "\n", + "[2 rows x 4 columns]\n" + ] + } + ], + "source": [ + "# Perform a left join between df_matching_results and df_corpus\n", + "# df_matching_results is the output of the model prediction \n", + "# This combines the model's predictions with the actual criterion text\n", + "df_joined = pd.merge(df_matching_results, \n", + " df_corpus[['trial_id', 'criterion_type', 'criterion_number', 'criterion_text']], \n", + " on=['trial_id', 'criterion_type', 'criterion_number'], \n", + " how='left')\n", + "\n", + "# Display basic information about the joined DataFrame\n", + "print(df_joined.info())\n", + "\n", + "# Optional: Display the first few rows of the joined DataFrame\n", + "# print(df_joined.head())\n", + "\n", + "# Check for any unmatched rows (rows where criterion_text is NaN)\n", + "unmatched = df_joined[df_joined['criterion_text'].isna()]\n", + "print(f\"\\nNumber of rows without matching criterion_text: {len(unmatched)}\")\n", + "\n", + "# Calculate the percentage of matched rows\n", + "total_rows = len(df_joined)\n", + "matched_rows = total_rows - len(unmatched)\n", + "match_percentage = (matched_rows / total_rows) * 100\n", + "\n", + "# Print matching statistics\n", + "print(f\"\\nTotal rows: {total_rows}\")\n", + "print(f\"Matched rows: {matched_rows}\")\n", + "print(f\"Match percentage: {match_percentage:.2f}%\")\n", + "\n", + "# Display a sample of unmatched rows if any exist\n", + "if len(unmatched) > 0:\n", + " print(\"\\nSample of unmatched rows:\")\n", + " print(unmatched[['trial_id', 'criterion_type', 'criterion_number', 'brief_reasoning']].head())\n", + "\n", + "# Rename 'eligibility_label' to 'eligibility_label_predicted' for clarity\n", + "df_joined = df_joined.rename(columns={'eligibility_label': 'eligibility_label_predicted'})\n", + "\n", + "# Optional: Save the joined DataFrame to CSV\n", + "# df_joined.to_csv('matching_results_with_criterion_text.csv', index=False)\n", + "# print(\"\\nJoined DataFrame saved to 'matching_results_with_criterion_text.csv'\")\n", + "\n", + "\n", + "# 1. Data Integration: It combines the model's predictions (df_matching_results) with the actual criterion text (df_corpus), creating a comprehensive dataset for analysis.\n", + "# 2. Completeness Check: By using a left join, it ensures that all rows from df_matching_results are retained, even if there's no matching criterion text in df_corpus.\n", + "# 3. Data Quality Assessment: The code checks for unmatched rows, which could indicate discrepancies between the model's input and the corpus data.\n", + "# 4. Match Rate Calculation: It calculates and displays the percentage of successfully matched rows, providing a quick measure of data alignment.\n", + "# 5. Error Analysis: By displaying samples of unmatched rows, it allows for investigation of specific cases where data misalignment occurs.\n", + "# 6. Clear Labeling: Renaming 'eligibility_label' to 'eligibility_label_predicted' clearly distinguishes the model's predictions from any ground truth labels.\n", + "\n", + "# This process is essential for:\n", + "# - Validating the consistency between the model's input data and the corpus.\n", + "# - Identifying any discrepancies that could affect the model's performance or the validity of the analysis.\n", + "# - Preparing a comprehensive dataset that includes both the model's predictions and the full text of the criteria, enabling more detailed analysis.\n", + "\n", + "# The resulting df_joined DataFrame is a powerful tool for:\n", + "# - Analyzing the model's performance in the context of specific criterion texts.\n", + "# - Investigating cases where the model's predictions might be inconsistent with the actual criteria.\n", + "# - Performing qualitative analysis of the model's reasoning (brief_reasoning) in relation to the full criterion text.\n", + "\n", + "# The high match percentage (assuming it's close to 100%) would indicate good alignment between the model's input data and the corpus, which is crucial for the validity of your analysis. Any unmatched rows should be carefully examined as they might represent edge cases or data inconsistencies that could affect the model's performance." + ] + }, + { + "cell_type": "code", + "execution_count": 32, + "id": "cbc8c4c2-2383-4279-99e8-b5e3de4afeb9", + "metadata": {}, + "outputs": [ + { + "data": { + "text/html": [ + "
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patient_idTODOremovetrial_idcriterion_typecriterion_numberbrief_reasoningsentence_idseligibility_label_predictedcriterion_text
0sigir-201410NCT01397994inclusion0The patient has episodic chest pain but no evidence of chronic stable angina or abnormal Exercise Myocardial Perfusion Spect Scan.[0, 1]not includedPatients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes.
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1060 rows × 9 columns

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" + ], + "text/plain": [ + " patient_id TODOremove trial_id criterion_type criterion_number \\\n", + "0 sigir-20141 0 NCT01397994 inclusion 0 \n", + ".. ... ... ... ... ... \n", + "\n", + " brief_reasoning \\\n", + "0 The patient has episodic chest pain but no evidence of chronic stable angina or abnormal Exercise Myocardial Perfusion Spect Scan. \n", + ".. ... \n", + "\n", + " sentence_ids eligibility_label_predicted \\\n", + "0 [0, 1] not included \n", + ".. ... ... \n", + "\n", + " criterion_text \n", + "0 Patients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. \n", + ".. ... \n", + "\n", + "[1060 rows x 9 columns]" + ] + }, + "execution_count": 32, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "df_joined" + ] + }, + { + "cell_type": "code", + "execution_count": 33, + "id": "fb2d81da-02d7-4bb3-975e-b90fe75d6865", + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "Before merging:\n", + "Unique patient-trial combinations in df_joined: 103\n", + "Unique patient-trial combinations in df_final: 103\n", + "\n", + "After merging:\n", + "Unique patient-trial combinations in merged DataFrame: 99\n", + "\n", + "Total rows in original df_joined: 1060\n", + "Rows kept after inner join: 882\n", + "Percentage of rows kept: 83.21%\n", + "\n", + "Percentage of patient-trial combinations kept: 96.12%\n", + "\n", + "Number of patient-trial combinations lost in merge: 4\n", + "Sample of patient-trial combinations lost (up to 10):\n", + "[('sigir-201422', 'NCT00723788'), ('sigir-201413', 'NCT00163709'), ('sigir-20154', 'NCT00844987'), ('sigir-20145', 'NCT00163709')]\n", + "\n", + "Analyzing why patient-trial combinations were lost:\n", + "\n", + "Patient ID: sigir-201422, Trial ID: NCT00723788\n", + "Criteria in df_joined: 2\n", + "Criteria in df_final: 5\n", + "Matching criteria: 0\n", + "Sample of non-matching criteria:\n", + "From df_joined:\n", + "424 age 8-18 years, referred from emergency department for suspected appendicitis and receiving either ct scan or ultrasound of the abdomen for diagnosis\n", + " ... \n", + "Name: criterion_text_clean, Length: 2, dtype: object\n", + "From df_final:\n", + "415 age 8-18 years\n", + " ... \n", + "Name: criterion_text_clean, Length: 5, dtype: object\n", + "\n", + "Patient ID: sigir-201413, Trial ID: NCT00163709\n", + "Criteria in df_joined: 2\n", + "Criteria in df_final: 5\n", + "Matching criteria: 0\n", + "Sample of non-matching criteria:\n", + "From df_joined:\n", + "213 we plan to include all patients presenting to the ed with shortness of breath that are over 40 years old and present with an emergency department triage category of 3 or higher.\n", + " ... \n", + "Name: criterion_text_clean, Length: 2, dtype: object\n", + "From df_final:\n", + "216 all patients presenting to the ed with shortness of breath that are over 40 years old and present with an emergency department triage category of 3 or higher\n", + " ... \n", + "Name: criterion_text_clean, Length: 5, dtype: object\n", + "\n", + "Patient ID: sigir-20154, Trial ID: NCT00844987\n", + "Criteria in df_joined: 6\n", + "Criteria in df_final: 6\n", + "Matching criteria: 0\n", + "Sample of non-matching criteria:\n", + "From df_joined:\n", + "639 typical chest pain;\n", + " ... \n", + "Name: criterion_text_clean, Length: 5, dtype: object\n", + "From df_final:\n", + "622 typical chest pain\n", + " ... \n", + "Name: criterion_text_clean, Length: 5, dtype: object\n", + "\n", + "Patient ID: sigir-20145, Trial ID: NCT00163709\n", + "Criteria in df_joined: 2\n", + "Criteria in df_final: 5\n", + "Matching criteria: 0\n", + "Sample of non-matching criteria:\n", + "From df_joined:\n", + "92 we plan to include all patients presenting to the ed with shortness of breath that are over 40 years old and present with an emergency department triage category of 3 or higher.\n", + " ... \n", + "Name: criterion_text_clean, Length: 2, dtype: object\n", + "From df_final:\n", + "98 all patients presenting to the ed with shortness of breath that are over 40 years old and present with an emergency department triage category of 3 or higher\n", + " ... \n", + "Name: criterion_text_clean, Length: 5, dtype: object\n" + ] + } + ], + "source": [ + "# Function to clean text by stripping whitespace and converting to lowercase\n", + "def clean_text(text):\n", + " if pd.isna(text):\n", + " return text\n", + " return str(text).strip().lower()\n", + "\n", + "# Clean the criterion_text in both DataFrames\n", + "df_joined['criterion_text_clean'] = df_joined['criterion_text'].apply(clean_text)\n", + "df_final['criterion_text_clean'] = df_final['criterion_text'].apply(clean_text)\n", + "\n", + "# Count unique patient-trial combinations before merging\n", + "patient_trials_in_joined = df_joined.groupby(['patient_id', 'trial_id']).size().reset_index(name='count')\n", + "patient_trials_in_final = df_final.groupby(['patient_id', 'trial_id']).size().reset_index(name='count')\n", + "\n", + "print(\"Before merging:\")\n", + "print(f\"Unique patient-trial combinations in df_joined: {len(patient_trials_in_joined)}\")\n", + "print(f\"Unique patient-trial combinations in df_final: {len(patient_trials_in_final)}\")\n", + "\n", + "# Perform the inner join with cleaned text\n", + "df_merged = pd.merge(df_joined, \n", + " df_final, \n", + " on=['patient_id', 'trial_id', 'criterion_type', 'criterion_text_clean'], \n", + " how='inner',\n", + " suffixes=('', '_final'))\n", + "\n", + "# Count unique patient-trial combinations after merging\n", + "patient_trials_after_merge = df_merged.groupby(['patient_id', 'trial_id']).size().reset_index(name='count')\n", + "\n", + "print(\"\\nAfter merging:\")\n", + "print(f\"Unique patient-trial combinations in merged DataFrame: {len(patient_trials_after_merge)}\")\n", + "\n", + "# Calculate the number and percentage of rows kept after the merge\n", + "rows_kept = len(df_merged)\n", + "rows_original = len(df_joined)\n", + "percentage_kept = (rows_kept / rows_original) * 100\n", + "\n", + "print(f\"\\nTotal rows in original df_joined: {rows_original}\")\n", + "print(f\"Rows kept after inner join: {rows_kept}\")\n", + "print(f\"Percentage of rows kept: {percentage_kept:.2f}%\")\n", + "\n", + "# Calculate percentage of patient-trial combinations kept\n", + "percentage_combinations_kept = (len(patient_trials_after_merge) / len(patient_trials_in_joined)) * 100\n", + "print(f\"\\nPercentage of patient-trial combinations kept: {percentage_combinations_kept:.2f}%\")\n", + "\n", + "# Find patient-trial combinations that were lost in the merge\n", + "combinations_lost = set(zip(patient_trials_in_joined['patient_id'], patient_trials_in_joined['trial_id'])) - \\\n", + " set(zip(patient_trials_after_merge['patient_id'], patient_trials_after_merge['trial_id']))\n", + "print(f\"\\nNumber of patient-trial combinations lost in merge: {len(combinations_lost)}\")\n", + "\n", + "if combinations_lost:\n", + " print(\"Sample of patient-trial combinations lost (up to 10):\")\n", + " print(list(combinations_lost)[:10])\n", + "\n", + "# Analyze why patient-trial combinations were lost\n", + "if combinations_lost:\n", + " print(\"\\nAnalyzing why patient-trial combinations were lost:\")\n", + " for patient_id, trial_id in list(combinations_lost)[:5]: # Analyze first 5 lost combinations\n", + " joined_criteria = df_joined[(df_joined['patient_id'] == patient_id) & (df_joined['trial_id'] == trial_id)]\n", + " final_criteria = df_final[(df_final['patient_id'] == patient_id) & (df_final['trial_id'] == trial_id)]\n", + " \n", + " print(f\"\\nPatient ID: {patient_id}, Trial ID: {trial_id}\")\n", + " print(f\"Criteria in df_joined: {len(joined_criteria)}\")\n", + " print(f\"Criteria in df_final: {len(final_criteria)}\")\n", + " \n", + " if len(final_criteria) == 0:\n", + " print(\"This patient-trial combination does not exist in df_final\")\n", + " else:\n", + " merged_criteria = pd.merge(joined_criteria, final_criteria, \n", + " on=['patient_id', 'trial_id', 'criterion_type', 'criterion_text_clean'],\n", + " how='inner')\n", + " print(f\"Matching criteria: {len(merged_criteria)}\")\n", + " \n", + " if len(merged_criteria) == 0:\n", + " print(\"Sample of non-matching criteria:\")\n", + " print(\"From df_joined:\")\n", + " print(joined_criteria['criterion_text_clean'].head())\n", + " print(\"From df_final:\")\n", + " print(final_criteria['criterion_text_clean'].head())\n", + "\n", + "\n", + "# 1. Data Cleaning: It standardizes the criterion text across both dataframes, ensuring consistent comparison.\n", + "# 2. Merge Quality Assessment: It thoroughly analyzes the merge operation between df_joined and df_final, providing detailed statistics on data retention and loss.\n", + "# 3. Combination Tracking: By tracking patient-trial combinations before and after the merge, it helps identify any specific cases that might be lost in the process.\n", + "# 4. Data Loss Investigation: For combinations that didn't make it through the merge, it provides a detailed analysis to understand why, which is crucial for data integrity.\n", + "# 5. Merge Validation: The code verifies that the merge operation maintains the integrity of the data and identifies any discrepancies.\n", + " \n", + "# Key aspects of this process:\n", + "# - Text Cleaning: Ensures that minor differences in text formatting don't cause mismatches.\n", + "# - Inner Join: Only keeps rows where there's a match in both dataframes, which could lead to data loss but ensures high-quality matches.\n", + "# - Detailed Statistics: Provides percentages of rows and combinations kept, giving a clear picture of data retention.\n", + "# - Loss Analysis: Investigates specific cases of data loss, which is crucial for understanding any systematic issues in the data or merge process.\n", + "\n", + "# This thorough approach to data merging and validation is essential for:\n", + "# - Ensuring the reliability of your final dataset.\n", + "# - Identifying any systematic issues in data collection or processing.\n", + "# - Providing a clear understanding of what data is included in your final analysis.\n", + "# - Enabling informed decisions about how to handle any data discrepancies or losses.\n", + "\n", + "\n", + "# These results provide valuable insights into the data merging process and the quality of your datasets. Let's break down what these results mean:\n", + "\n", + "# 1. Overall Retention:\n", + "# - 83.49% of rows were kept after the merge, which is a good retention rate.\n", + "# - 96.12% of patient-trial combinations were retained, which is excellent.\n", + "\n", + "# 2. Data Loss:\n", + "# - Only 4 out of 103 patient-trial combinations were lost (3.88% loss).\n", + "# - This small loss suggests generally good alignment between df_joined and df_final.\n", + "\n", + "# 3. Specific Cases of Data Loss:\n", + "# The analysis of lost combinations reveals interesting patterns:\n", + "\n", + "# a) Criterion Splitting:\n", + "# - In most cases, criteria in df_final are split into separate rows, while in df_joined they are combined.\n", + "# - Example: For 'sigir-201422', df_joined has 2 criteria, while df_final has 5.\n", + "\n", + "# b) Text Formatting:\n", + "# - Despite cleaning, there are still differences in how criteria are formatted.\n", + "# - Example: \"age 8-18 years\" vs. \"age 8-18 years, referred from emergency department...\"\n", + "\n", + "# c) Consistent Pattern:\n", + "# - This splitting pattern is consistent across all analyzed lost combinations.\n", + "\n", + "# d) Missing Data:\n", + "# - One NaN value in df_joined for 'sigir-20154', which could contribute to the mismatch.\n", + "\n", + "# 4. Implications:\n", + "# a) Data Processing Differences:\n", + "# - There seems to be a systematic difference in how criteria are processed or stored between df_joined and df_final.\n", + "# - df_final consistently has more granular (split) criteria compared to df_joined.\n", + "\n", + "# b) Text Matching Challenges:\n", + "# - Even with cleaning, exact text matching is challenging due to differences in criterion grouping.\n", + "\n", + "# c) Potential for Improvement:\n", + "# - The consistent pattern suggests that adjusting the merging strategy could potentially recover these lost combinations.\n", + "\n", + "# 5. Recommendations:\n", + "# a) Criterion Splitting:\n", + "# - Consider splitting the criteria in df_joined to match the granularity in df_final before merging.\n", + "\n", + "# b) Fuzzy Matching:\n", + "# - Implement a fuzzy matching algorithm to account for minor text differences.\n", + "\n", + "# c) Manual Review:\n", + "# - Given the small number of lost combinations, a manual review and correction might be feasible.\n", + "\n", + "# d) Standardization:\n", + "# - Develop a standardized process for criterion formatting to ensure consistency across datasets in future.\n", + "\n", + "# 6. Overall Assessment:\n", + "# - The merge process has been largely successful, retaining over 96% of patient-trial combinations.\n", + "# - The lost combinations appear to be due to systematic differences in data formatting rather than data quality issues.\n", + "# - With some refinement in the merging process, it's likely that even higher retention rates could be achieved.\n" + ] + }, + { + "cell_type": "code", + "execution_count": 34, + "id": "bd270f6c-46f9-4084-96e1-97df52287f33", + "metadata": { + "scrolled": true + }, + "outputs": [ + { + "data": { + "text/html": [ + "
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patient_idTODOremovetrial_idcriterion_typecriterion_numberbrief_reasoningsentence_idseligibility_label_predictedcriterion_textcriterion_text_cleantextscoreannotation_idnotetrial_titlecriterion_text_finalgpt4_explanationexplanation_correctnessgpt4_sentencesexpert_sentencesgpt4_eligibilityexpert_eligibilitytrainingnum_trialsnum_distinct_criteria
0sigir-201410NCT01397994inclusion0The patient has episodic chest pain but no evidence of chronic stable angina or abnormal Exercise Myocardial Perfusion Spect Scan.[0, 1]not includedPatients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes.patients of chronic stable angina with abnormal exercise myocardial perfusion spect scan with reversible and partially reversible ischemic changes.A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is ...100. A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life.\\n1. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, ...Study to Assess Efficacy of Nicorandil+Atenolol vs Atenolol in Treatment of Chronic Stable Angina.Patients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes.The patient note does not provide direct evidence of the patient having chronic stable angina or having undergone an Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. However, the patient does present with symptoms of chest pain, which could be i...Correct[0, 1, 2][0, 1, 2]not enough informationnot enough informationTrue231
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882 rows × 25 columns

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" + ], + "text/plain": [ + " patient_id TODOremove trial_id criterion_type criterion_number \\\n", + "0 sigir-20141 0 NCT01397994 inclusion 0 \n", + ".. ... ... ... ... ... \n", + "\n", + " brief_reasoning \\\n", + "0 The patient has episodic chest pain but no evidence of chronic stable angina or abnormal Exercise Myocardial Perfusion Spect Scan. \n", + ".. ... \n", + "\n", + " sentence_ids eligibility_label_predicted \\\n", + "0 [0, 1] not included \n", + ".. ... ... \n", + "\n", + " criterion_text \\\n", + "0 Patients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. \n", + ".. ... \n", + "\n", + " criterion_text_clean \\\n", + "0 patients of chronic stable angina with abnormal exercise myocardial perfusion spect scan with reversible and partially reversible ischemic changes. \n", + ".. ... \n", + "\n", + " text \\\n", + "0 A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is ... \n", + ".. ... \n", + "\n", + " score annotation_id \\\n", + "0 1 0 \n", + ".. ... ... \n", + "\n", + " note \\\n", + "0 0. A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life.\\n1. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, ... \n", + ".. ... \n", + "\n", + " trial_title \\\n", + "0 Study to Assess Efficacy of Nicorandil+Atenolol vs Atenolol in Treatment of Chronic Stable Angina. \n", + ".. ... \n", + "\n", + " criterion_text_final \\\n", + "0 Patients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. \n", + ".. ... \n", + "\n", + " gpt4_explanation \\\n", + "0 The patient note does not provide direct evidence of the patient having chronic stable angina or having undergone an Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. However, the patient does present with symptoms of chest pain, which could be i... \n", + ".. ... \n", + "\n", + " explanation_correctness gpt4_sentences expert_sentences \\\n", + "0 Correct [0, 1, 2] [0, 1, 2] \n", + ".. ... ... ... \n", + "\n", + " gpt4_eligibility expert_eligibility training num_trials \\\n", + "0 not enough information not enough information True 2 \n", + ".. ... ... ... ... \n", + "\n", + " num_distinct_criteria \n", + "0 31 \n", + ".. ... \n", + "\n", + "[882 rows x 25 columns]" + ] + }, + "execution_count": 34, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "df_merged" + ] + }, + { + "cell_type": "code", + "execution_count": 35, + "id": "a3118c17-640d-4036-a29f-1e7375965fef", + "metadata": {}, + "outputs": [ + { + "data": { + "image/png": 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", + "text/plain": [ + "
" + ] + }, + "metadata": {}, + "output_type": "display_data" + }, + { + "name": "stdout", + "output_type": "stream", + "text": [ + "\n", + "df_final Classification Report:\n", + " precision recall f1-score support\n", + "\n", + " excluded 0.60 1.00 0.75 9\n", + " included 0.97 0.90 0.93 149\n", + " not applicable 0.48 0.98 0.65 55\n", + "not enough information 0.88 0.88 0.88 285\n", + " not excluded 0.97 0.86 0.91 476\n", + " not included 0.72 0.78 0.75 23\n", + "\n", + " accuracy 0.88 997\n", + " macro avg 0.77 0.90 0.81 997\n", + " weighted avg 0.91 0.88 0.89 997\n", + "\n", + "\n", + "df_final Overall F1 Score (weighted): 0.8870\n", + "\n", + "df_final True Label Distribution:\n", + "expert_eligibility\n", + "not excluded 0.477432\n", + " ... \n", + "Name: proportion, Length: 6, dtype: float64\n", + "\n", + "df_final Prediction Distribution:\n", + "gpt4_eligibility\n", + "not excluded 0.424273\n", + " ... \n", + "Name: proportion, Length: 6, dtype: float64\n" + ] + }, + { + "data": { + "image/png": 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", + "text/plain": [ + "
" + ] + }, + "metadata": {}, + "output_type": "display_data" + }, + { + "name": "stdout", + "output_type": "stream", + "text": [ + "\n", + "df_merged (predicted) Classification Report:\n", + " precision recall f1-score support\n", + "\n", + " excluded 0.35 0.75 0.48 8\n", + " included 0.81 0.83 0.82 124\n", + " not applicable 0.71 0.51 0.59 53\n", + "not enough information 0.44 0.71 0.55 255\n", + " not excluded 0.84 0.52 0.65 426\n", + " not included 0.25 0.38 0.30 16\n", + "\n", + " accuracy 0.62 882\n", + " macro avg 0.57 0.62 0.56 882\n", + " weighted avg 0.70 0.62 0.63 882\n", + "\n", + "\n", + "df_merged (predicted) Overall F1 Score (weighted): 0.6308\n", + "\n", + "df_merged (predicted) True Label Distribution:\n", + "expert_eligibility\n", + "not excluded 0.482993\n", + " ... \n", + "Name: proportion, Length: 6, dtype: float64\n", + "\n", + "df_merged (predicted) Prediction Distribution:\n", + "eligibility_label_predicted\n", + "not enough information 0.46712\n", + " ... \n", + "Name: proportion, Length: 6, dtype: float64\n" + ] + }, + { + "data": { + "image/png": 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nTp109uxZi8uyPEhGj5O747vzWMsO7Ol3pXbt2ho0aJBGjhypgQMHqm7duuZlj+IzacWKFS2uKZ/eZ9I1a9ZYxHz72nmHDh3SoUOHlJycnO5rKawjq97fH3bbsbGxeuyxxyz+bvo3MnIsbd++XYZhKDg42OKYjI6O5nMpAOCRuPPcnXSrW8vdYw+an954TvSwz+VtixYtUmRkpJYsWaJChQo9qvCynYw+nykpKerQocP/tXfvcTXl+//AX6X2titF0V1CUjEl9+pLM0g4p5P7nNEZRYaOu2jwGCpijFsGucygFOXhYeQcd5owyCVRbu2EcpuRy5nGfRjtz+8Pj9av3c3eSMrr+XjsP9b6fNZnvdfan7X22uuzPp+FWbNmvbPrttpIm/qpUqmgo6ODxMREdOzYEX369EF0dDTWr1//0fcaB7Tbl9nZ2Rg/fjzCw8Nx+vRp7N27F/n5+QgJCXkfodZ6etUdABFVn+Jhpnft2gUbGxu1NLlcDgB4+vQpTp8+jTp16kjD8BVTKBQar6v4BnXxhS+AMsMllUyrLOZRo0Zh/PjxZdLs7Oyk95jywrr20dfXV5vW0dGR6rA2dRF4VR9L17eS9VGTP2gqlQpWVlblvvuZD2J8WCqrOxVdhGr6R7SkoKAg3Lt3D99//z2aNGkCuVwODw8PvHjx4rXLarIuTeOp7Hh48uQJevbsiZ49e2Ljxo1o1KgRbty4AV9f37eKU6VSYdasWWrvMi9WsjH2Q/E+6kRxeWvWrEGnTp3U0koPp1synuJ1VBZP6fOXjo7Oa89prytDk1g09SZlaPIH0dDQsNJ1FZdT2fd7/fp19OnTByEhIYiKioKpqSmOHj2K4OBgrYZx1LSeVBZLTfAhHSsqlQppaWlvfU0KaHbMaBK3n58f5s+fXybNysqqTIz07r2v33dt111V16WVUalUqFOnjvS/rSQjIyONyyEiInqdhg0bok6dOigoKFCbf/fuXVhYWJS7jKWlZbn59fT0YGZmVmWxfujeZF8W27x5M4KDg7Flyxb06NGjKsOsMbTdn48ePUJGRgYyMzOlV3SqVCoIIaCnp4f9+/ejW7du7yX2D9Gb1E8rKyvY2NjAxMREmufs7AwhBG7duoUWLVpUacwfqjfZl/PmzYOXlxfCwsIAvHow19DQEF26dMGcOXOkTgj0ZthjnOgj5uLiArlcjhs3bsDBwUHtU9y7YvLkydDV1cWePXuwbNkyHDhwQFre1dUVqampGq2rUaNGAF69j7FYVlZWmXhKvgMUQJnptm3b4uLFi2XidXBwgEwmg7OzM16+fImMjAxpmUuXLuGPP/7QKE6qmVxdXZGVlSW92/t1GjVqpFYXi4qKcOHCBWlak3rUtm1bFBQUQE9Pr0xdbNiwoVTO6+o0VS8XFxfcuHEDN2/elOZlZ2fjwYMHcHZ2BgDIZDKNeuYeOXIE48ePR58+fdCqVSvI5XLcv3+/TL7y6kRxL8Py8rx8+RKnT58uk6cilZ2bc3JycP/+fXz33Xfo0qULnJycKuy9WjKGwsJC5ObmVhhD27ZtcenSpXLPzSV77tYE76pOWFhYwMbGBnl5eWX2SdOmTbWK5+jRo2rzjh07BkdHR6nxo/Q57fLly2o99Z2cnHDu3Dk8f/5cmlfy/FbdnJ2dy93G4v39LmVkZODly5dYvHgxOnfuDEdHR/z2229qeTT5fjWpJ7Xd+z5WFi5cCKVSiV9++QX79u1DXFyclKbNNSnw+mPGxcUFZ8+eVevVUNE1qb29fZm4DQ0N4eDgAH19/XLPpVT13uXvu7ZcXV1x69Ytjb/r0vURUP+fpEldcnd3R1FREe7evVumPlpaWgLQ7L8WERHR68hkMrRr1w4pKSlq81NSUuDp6VnuMh4eHmXy79+/H+3bty/zsNnH5E32JfCqp3hQUBCSkpL4vuEStN2fxsbGOH/+PLKysqRPSEgIWrZsiaysrDIP7X5s3qR+enl54bfffsPjx4+lebm5udDV1YWtrW2Vxvshe5N9+fTp0zL304rvAfGB17dXs+5UEtE7Va9ePUyZMgWTJk1CfHw8rl69iszMTKxYsQLx8fHYtWsXYmNjkZiYCB8fH0ybNg2BgYEoLCwEAERERGDTpk2IiIiAUqnE+fPnsWDBgnLXpVAo0LlzZ3z33XfIzs7G4cOHMWPGDLU8ISEhuHr1KkJDQ3Hp0iUkJSVh/fr1anmmTp2K48ePY8yYMcjKysLly5exfft2jBs3DgDQsmVL9OrVC1999RVOnjyJ06dPY8SIEVr33KCa5YsvvoClpSX69u2LtLQ05OXlYevWrTh+/Hi5+bt164Zdu3Zh165dyMnJwejRo9UavTWpRz169ICHhwf69u2Lffv24dq1azh27BhmzJghNThNmDABsbGxiI2NRW5uLiIiInDx4sUq3ReknR49esDV1RUBAQE4c+YM0tPTMXToUHh7e0vDNtvb2yM/Px9ZWVm4f/++WuNiSQ4ODtiwYQOUSiVOnjyJgICAcs89W7ZsUasT6enp0tPJxVasWIFt27YhJycHY8aMQWFhIYYPH67RNlV2brazs4NMJsPy5cuRl5eH7du3IyoqqtxyZs+ejdTUVFy4cAFBQUFo2LAh+vbtW27e8PBwJCQkIDIyEhcvXoRSqcTmzZvLnOdrgndZJyIjIzFv3jwsXboUubm5OH/+POLi4hAdHa1xPJMnT0ZqaiqioqKQm5uL+Ph4xMTEYMqUKVKebt26ISYmBmfOnEFGRgZCQkLUbjANGTIEKpUKI0eOhFKpxL59+7Bo0SIAH8YIK2FhYVi/fj1Wr16Ny5cvIzo6GsnJyWrb+K40b94cL1++lI6BDRs2YPXq1Wp57O3t8fjxY6SmpuL+/fvlvg5Ak3pS273PYyUrKwvh4eFYt24dvLy8sHTpUkyYMAF5eXkAgOnTp+PUqVMYPXo0zp07h5ycHKxatarch5MAzY4ZXV1dBAcHIzs7G7t375aOmWJjxozB77//ji+++ALp6enIy8vD/v37MXz4cBQVFcHIyAjBwcEICwtTO5fWtIeFaqp3WT+15e3tja5du2LAgAFISUlBfn4+9uzZg71795abv1u3bsjIyEBCQgIuX76MiIgItQc2NalLjo6OCAgIwNChQ5GcnIz8/HycOnUK8+fPx+7duwEA48ePx969e7FgwQLk5uYiJiamwpiIiIgqExoairVr1yI2NhZKpRKTJk3CjRs3pCF+p0+fjqFDh0r5Q0JCcP36dYSGhkKpVCI2Nhbr1q2rkuv9mkbbfblp0yYMHTpUetC3oKAABQUFePDgQXVtwgdFm/2pq6uL1q1bq33Mzc1Rt25dtG7dutwRyz422tbPIUOGwMzMDMOGDZPu/4eFhWH48OEf/b15bfeln58fkpOTsWrVKuTl5SEtLQ3jx49Hx44dYW1tXV2bUXtU8TvMiegDp1KpxNKlS0XLli2Fvr6+aNSokfD19RWHDh0SFhYW4ttvv5Xy/vXXX6Jjx45i8ODB0rytW7eKNm3aCJlMJho2bCj69+8vpTVp0kQsWbJEms7OzhadO3cWCoVCtGnTRuzfv18AEAcPHpTy7NixQzg4OAi5XC66dOkiYmNjBQBRWFgo5UlPTxc+Pj7CyMhIGBoaCldXVzF37lwp/fbt2+Jvf/ubkMvlws7OTiQkJJSJhT583t7eYsKECUKIsnVJCCHc3NxERESENH3t2jUxYMAAYWxsLAwMDET79u3FyZMnhRBCRERECDc3NynvixcvxL///W9hamoqzM3Nxbx584S/v78IDAyU8mhSjx4+fCjGjRsnrK2thb6+vmjcuLEICAgQN27ckPLMnTtXNGzYUBgZGYnAwEDx9ddfq8VCVatkPSpW+ru+fv26+Mc//iEMDQ1FvXr1xKBBg0RBQYGU/ueff4oBAwaI+vXrCwAiLi6u3HWdOXNGtG/fXsjlctGiRQuxZcuWMnUGgFixYoXw8fERcrlcNGnSRGzatElKz8/PFwBEUlKS6NSpk5DJZMLZ2VmkpqZKeQ4ePKh2XoyLixMmJiZqsVR2bk5KShL29vZCLpcLDw8PsX37dgFAZGZmqpW/Y8cO0apVKyGTyUSHDh1EVlaWVEZ569y7d6/w9PQUCoVCGBsbi44dO4off/yx3H1Vnd5nnRBCiMTEROm7aNCggejatatITk4WQvz/77t43wshRGFhYZnfxp9++km4uLgIfX19YWdnJxYuXKi2jl9//VX07NlTGBoaihYtWojdu3cLExMTtbjS0tKEq6urkMlkol27diIpKUkAEDk5OUKIsvVKCCEyMzMFAJGfn1/utpWOX5MyKipz5cqVolmzZkJfX184OjqKhIQEtXQAYtu2bWrzSp/bhRAiMDBQ+Pv7q80r/Z1HR0cLKysroVAohK+vr0hISCgTd0hIiDAzMxMApN+a0sfz6+pJefEtWbJENGnSRNQEH8qx8uzZM+Hi4iJGjhyplr9fv37C09NTvHz5UgghxKFDh4Snp6eQy+Wifv36wtfXV/pOS2+LJsfM8ePHhZubm5DJZKJNmzZi69atZY7X3Nxc0a9fP1G/fn2hUCiEk5OTmDhxolCpVEIIIR49eiT+9a9/CQMDA2FhYSEWLFhQ7n4l7b3P+ln6vKLJuv/3v/+JYcOGCTMzM1G3bl3RunVrsXPnTiFE+b+h4eHhwsLCQpiYmIhJkyaJsWPHCm9vbyldk7r04sULER4eLuzt7YW+vr6wtLQU/fr1E+fOnZPyrFu3Ttja2gqFQiH8/PzEokWLysRCRESkiRUrVogmTZoImUwm2rZtK3755RcpLTAwUO13TIhX12ru7u5CJpMJe3t7sWrVqvcc8YdLm33p7e0tAJT5lLwO+dhpWzdLKu8/3MdO2/2pVCpFjx49hEKhELa2tiI0NFQ8ffr0PUf9YdJ2Xy5btky4uLgIhUIhrKysREBAgLh169Z7jrp20hGC/e6JiIiI3gcdHR1s27atwp7X165dQ9OmTZGZmYk2bdq819jo45KYmIhhw4bhwYMHH/2T20RERERERERE9HHQq+4AiIiIiIioaiUkJKBZs2awsbHB2bNnMXXqVAwePJiN4kRERERERERE9NFgwzgRERERUS1XUFCA8PBwFBQUwMrKCoMGDcLcuXOrOywiIiIiIiIiIqL3hkOpExERERERERERERERERFRraZb3QEQERERERERERERERERERFVJTaMExERERERERERERERERFRrcaGcSIiIiIiIiIiIiIiIiIiqtXYME5ERERERERERERERERERLUaG8aJiIiIiIiIiIiIiIiIiKhWY8M4EREREdVK165dg46ODrKysgAAhw4dgo6ODv744w+Ny4iMjESbNm2k6aCgIPTt27fSZT799FNMnDhRmra3t8f3338vTevo6OA///mPxjEQERERERERERHR22PDOBERERFVudc1BqelpUFPT0+tEfpd8/T0xO3bt2FiYqLxMlOmTEFqaqpW60lOTkZUVFSF6bdv30bv3r0BlG28JyIiIiIiIqLqFxQUBB0dnTKfK1euAAAOHz4MPz8/WFtba/wAfFFREebNmwcnJycoFAqYmpqic+fOiIuLq+KtIaJietUdABERERF93B48eIChQ4eie/fuuHPnTpWtRyaTwdLSUqtljIyMYGRkpNUypqamlaZrGwMRERERERERvX+9evUq02jdqFEjAMCTJ0/g5uaGYcOGYcCAARqVFxkZiR9//BExMTFo3749Hj58iIyMDBQWFr7z2Iu9ePECMpmsysonqmnYY5yIiIiIKvXo0SMEBATA0NAQVlZWWLJkidpw4fb29oiKisKQIUNgZGQEa2trLF++XFre3t4eANCvXz/o6OhI08VGjRqFIUOGwMPDQ+vY4uLi4OzsjLp168LJyQkrV66sMG95Q6mvWbMGjRs3hoGBAfr164fo6GjUr19fSi89lHqxWbNmwdzcHMbGxhg1ahRevHghpZUeSr20kk+SN23aFADg7u4OHR0dfPrppzh8+DD09fVRUFCgttzkyZPRtWvXincGEREREREREb0zcrkclpaWap86deoAAHr37o05c+agf//+Gpe3Y8cOjB49GoMGDULTpk3h5uaG4OBghIaGSnlUKhXmz58PBwcHyOVy2NnZYe7cuVL6+fPn0a1bNygUCpiZmWHkyJF4/PixlF78Crh58+bB2toajo6OAIBff/0Vn3/+ORo0aAAzMzP4+/vj2rVrb7mHiGoeNowTERERUaVCQ0ORlpaG7du3IyUlBUeOHMGZM2fU8ixcuBCurq44c+YMpk+fjkmTJiElJQUAcOrUKQCvGrFv374tTRfPu3r1KiIiIrSOa82aNfjmm28wd+5cKJVKfPvtt5g5cybi4+M1Wj4tLQ0hISGYMGECsrKy4OPjo/ZnsyKpqalQKpU4ePAgNm3ahG3btmHWrFlaxw8A6enpAICff/4Zt2/fRnJyMrp27YpmzZphw4YNUr6XL19i48aNGDZs2Buth4iIiIiIiIiql6WlJQ4cOIB79+5VmGf69OmYP38+Zs6ciezsbCQlJcHCwgIA8PTpU/Tq1QsNGjTAqVOnsGXLFvz8888YO3asWhnF9y1SUlKwc+dOPH36FJ999hmMjIxw+PBhHD16FEZGRujVq5fag/5EHwMOpU5EREREFXr06BHi4+ORlJSE7t27A3jVmG1tba2Wz8vLC9OmTQMAODo6Ii0tDUuWLIGPj480zFj9+vXVhhG/fPkypk2bhiNHjkBPT/vL0qioKCxevFh6Ortp06bIzs7GDz/8gMDAwNcuv3z5cvTu3RtTpkyR4j527Bh27txZ6XIymQyxsbEwMDBAq1atMHv2bISFhSEqKgq6uto9d1q8b8zMzNT2TXBwMOLi4hAWFgYA2LVrF54+fYrBgwdrVT4RERERERERvZmdO3eqvV6td+/e2LJlyxuXFx0djYEDB8LS0hKtWrWCp6cn/P390bt3bwCv7sEsXboUMTEx0n2N5s2b4//+7/8AAImJiXj27BkSEhJgaGgIAIiJiYGfnx/mz58vNaAbGhpi7dq10hDqsbGx0NXVxdq1a6GjowPg1b2d+vXr49ChQ+jZs+cbbxNRTcMe40RERERUoby8PPz111/o2LGjNM/ExAQtW7ZUy1d6GHQPDw8olcoKyy0qKsKQIUMwa9YsaVgvbdy7dw83b95EcHCw9B5wIyMjzJkzB1evXtWojEuXLqltF4Ay0+Vxc3ODgYGBNO3h4YHHjx/j5s2b2m1EJYKCgnDlyhWcOHECwKs/sYMHD5b++BIRERERERFR1frss8+QlZUlfZYtW/ZW5bm4uODChQs4ceIEhg0bhjt37sDPzw8jRowAACiVSjx//lzqmFCaUqmEm5ub2r0BLy8vqFQqXLp0SZr3ySefqL1X/PTp07hy5Qrq1asn3T8xNTXFn3/+qfE9FKLagj3GiYiIiKhCQggAkJ4oLj2/MqWXKenRo0fIyMhAZmamNOSXSqWCEAJ6enrYv38/unXrVuHyKpUKwKvh1Dt16qSWVvy+r9cRQrzRdlWksu3Vlrm5Ob2GddMAAAXYSURBVPz8/BAXF4dmzZph9+7dOHTo0Dsrn4iIiIiIiIgqZ2hoCAcHh3dapq6uLjp06IAOHTpg0qRJ2LhxI7788kt88803UCgUlS5b3n2MYiXnl36oXqVSoV27dkhMTCyzXPFIdkQfCzaMExEREVGFmjdvDn19faSnp6Nx48YAgIcPH+Ly5cvw9vaW8hX3bC457eTkJE3r6+ujqKhImjY2Nsb58+fVllm5ciUOHDiAn376CU2bNq00LgsLC9jY2CAvLw8BAQFvtG1OTk7SO76LZWRkvHa5s2fP4tmzZ9If1hMnTsDIyAi2trZax1D8BHfJfVNsxIgR+Oc//wlbW1s0b94cXl5eWpdPRERERERERB8uFxcXAMCTJ0/QokULKBQKpKamSr3IS+eNj4/HkydPpMbvtLQ06OrqVjoaX9u2bbF582aYm5vD2Ni4ajaEqIZgwzgRERERVahevXoIDAxEWFgYTE1NYW5ujoiICOjq6qo9jZyWloYFCxagb9++SElJwZYtW7Br1y4p3d7eHqmpqfDy8oJcLkeDBg3QunVrtXWZm5ujbt26ZeZXJDIyEuPHj4exsTF69+6N58+fIyMjA4WFhQgNDX3t8uPGjUPXrl0RHR0NPz8/HDhwAHv27Hltz+8XL14gODgYM2bMwPXr1xEREYGxY8dq/X5x4NU2KxQK7N27F7a2tqhbty5MTEwAAL6+vjAxMcGcOXMwe/ZsrcsmIiIiIiIioqrx+PFjXLlyRZrOz89HVlYWTE1NYWdnV+4yAwcOhJeXFzw9PWFpaYn8/HxMnz4djo6OcHJygp6eHqZOnYqvv/4aMpkMXl5euHfvHi5evIjg4GAEBAQgIiICgYGBiIyMxL179zBu3Dh8+eWX0vvFyxMQEICFCxfC398fs2fPhq2tLW7cuIHk5GSEhYW90YP+RDUV3zFORERERJWKjo6Gh4cH/v73v6NHjx7w8vKCs7Mz6tatK+WZPHkyTp8+DXd3d0RFRWHx4sXw9fWV0hcvXoyUlBQ0btwY7u7u7ySuESNGYO3atVi/fj0++eQTeHt7Y/369a/tbV7My8sLq1evRnR0NNzc3LB3715MmjRJbbvK0717d7Ro0QJdu3bF4MGD4efnh8jIyDfaBj09PSxbtgw//PADrK2t4e/vL6Xp6uoiKCgIRUVFGDp06BuVT0RERERERETvXkZGBtzd3aV7HKGhoXB3d0d4eHiFy/j6+mLHjh3w8/ODo6MjAgMD4eTkhP3790NP71U/1pkzZ2Ly5MkIDw+Hs7MzPv/8c9y9excAYGBggH379uH3339Hhw4dMHDgQHTv3h0xMTGVxmpgYIDDhw/Dzs4O/fv3h7OzM4YPH45nz56xBzl9dHTE27xIkYiIiIg+Ok+ePIGNjQ0WL16M4OBg2NvbY+LEiZg4cWJ1h/bWvvrqK+Tk5ODIkSPVHQqAV/HcuXMH27dvr+5QiIiIiIiIiIiIajQOpU5ERERElcrMzEROTg46duyIBw8eSMN6l+zdXFMtWrQIPj4+MDQ0xJ49exAfH4+VK1dWd1h48OABTp06hcTERPz3v/+t7nCIiIiIiIiIiIhqPDaMExEREdFrLVq0CJcuXYJMJkO7du1w5MgRNGzYsErXaWRkVGHanj170KVLl7deR3p6OhYsWIBHjx6hWbNmWLZsGUaMGPHW5b4tf39/pKenY9SoUfDx8anucIiIiIiIiIiIiGo8DqVORERERB+kK1euVJhmY2MDhULxHqMhIiIiIiIiIiKimowN40REREREREREREREREREVKvpVncAREREREREREREREREREREVYkN40REREREREREREREREREVKuxYZyIiIiIiIiIiIiIiIiIiGo1NowTEREREREREREREREREVGtxoZxIiIiIiIiIiIiIiIiIiKq1dgwTkREREREREREREREREREtRobxomIiIiIiIiIiIiIiIiIqFZjwzgREREREREREREREREREdVq/w+IScrgFZBecgAAAABJRU5ErkJggg==", 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" + ] + }, + "metadata": {}, + "output_type": "display_data" + }, + { + "name": "stdout", + "output_type": "stream", + "text": [ + "\n", + "df_merged (GPT-4) Classification Report:\n", + " precision recall f1-score support\n", + "\n", + " excluded 0.62 1.00 0.76 8\n", + " included 0.97 0.92 0.95 124\n", + " not applicable 0.51 0.98 0.67 53\n", + "not enough information 0.89 0.88 0.88 255\n", + " not excluded 0.97 0.87 0.92 426\n", + " not included 0.65 0.69 0.67 16\n", + "\n", + " accuracy 0.88 882\n", + " macro avg 0.77 0.89 0.81 882\n", + " weighted avg 0.91 0.88 0.89 882\n", + "\n", + "\n", + "df_merged (GPT-4) Overall F1 Score (weighted): 0.8907\n", + "\n", + "df_merged (GPT-4) True Label Distribution:\n", + "expert_eligibility\n", + "not excluded 0.482993\n", + " ... \n", + "Name: proportion, Length: 6, dtype: float64\n", + "\n", + "df_merged (GPT-4) Prediction Distribution:\n", + "gpt4_eligibility\n", + "not excluded 0.429705\n", + " ... \n", + "Name: proportion, Length: 6, dtype: float64\n" + ] + } + ], + "source": [ + "def analyze_eligibility(df, true_col, pred_col, title_prefix):\n", + " # Get distinct labels from both true and predicted columns\n", + " labels = sorted(set(df[true_col].unique()) | set(df[pred_col].unique()))\n", + "\n", + " # Create a mapping of labels to numeric indices\n", + " label_to_index = {label: index for index, label in enumerate(labels)}\n", + "\n", + " # Convert string labels to numeric indices for sklearn compatibility\n", + " y_true = df[true_col].map(label_to_index)\n", + " y_pred = df[pred_col].map(label_to_index)\n", + "\n", + " # Generate the confusion matrix\n", + " cm = confusion_matrix(y_true, y_pred)\n", + "\n", + " # Create a DataFrame from the confusion matrix for better visualization\n", + " cm_df = pd.DataFrame(cm, index=labels, columns=labels)\n", + "\n", + " # Calculate F1 scores for each class\n", + " f1_scores = f1_score(y_true, y_pred, average=None, labels=range(len(labels)))\n", + "\n", + " # Create a DataFrame for F1 scores\n", + " f1_df = pd.DataFrame({'Eligibility': labels, 'F1 Score': f1_scores})\n", + "\n", + " # Plot the confusion matrix and F1 scores\n", + " fig, (ax1, ax2) = plt.subplots(1, 2, figsize=(20, 8), gridspec_kw={'width_ratios': [3, 1]})\n", + "\n", + " # Confusion Matrix plot\n", + " sns.heatmap(cm_df, annot=True, fmt='d', cmap='Blues', ax=ax1)\n", + " ax1.set_title(f'{title_prefix} Confusion Matrix: {true_col} vs. {pred_col}')\n", + " ax1.set_ylabel(true_col)\n", + " ax1.set_xlabel(pred_col)\n", + "\n", + " # F1 Scores plot\n", + " sns.barplot(x='F1 Score', y='Eligibility', data=f1_df, ax=ax2)\n", + " ax2.set_title(f'{title_prefix} F1 Scores by Eligibility Class')\n", + " ax2.set_xlabel('F1 Score')\n", + " ax2.set_ylabel('Eligibility')\n", + "\n", + " plt.tight_layout()\n", + " plt.show()\n", + "\n", + " # Print detailed classification report\n", + " print(f\"\\n{title_prefix} Classification Report:\")\n", + " print(classification_report(y_true, y_pred, target_names=labels))\n", + "\n", + " # Calculate and print overall weighted F1 score\n", + " overall_f1 = f1_score(y_true, y_pred, average='weighted')\n", + " print(f\"\\n{title_prefix} Overall F1 Score (weighted): {overall_f1:.4f}\")\n", + "\n", + " # Print label distribution for both true and predicted labels\n", + " print(f\"\\n{title_prefix} True Label Distribution:\")\n", + " print(df[true_col].value_counts(normalize=True))\n", + " print(f\"\\n{title_prefix} Prediction Distribution:\")\n", + " print(df[pred_col].value_counts(normalize=True))\n", + "\n", + "# Apply the analysis function to different datasets and comparisons\n", + "\n", + "# Compare GPT-4 predictions to expert labels in df_final\n", + "analyze_eligibility(df_final, 'expert_eligibility', 'gpt4_eligibility', 'df_final')\n", + "\n", + "# Compare model predictions to expert labels in df_merged\n", + "analyze_eligibility(df_merged, 'expert_eligibility', 'eligibility_label_predicted', 'df_merged (predicted)')\n", + "\n", + "# Compare GPT-4 predictions to expert labels in df_merged\n", + "analyze_eligibility(df_merged, 'expert_eligibility', 'gpt4_eligibility', 'df_merged (GPT-4)')\n", + "\n", + "# This code is crucial for several reasons:\n", + "# 1. Comprehensive Analysis: It provides a thorough evaluation of eligibility predictions, including confusion matrices, F1 scores, and label distributions.\n", + "# 2. Visualization: The function creates clear visual representations of the confusion matrix and F1 scores, making it easier to interpret the results.\n", + "# 3. Flexibility: The function is designed to work with different datasets and column names, allowing for easy comparison across different models or datasets.\n", + "# 4. Detailed Metrics: It calculates and displays various performance metrics, giving a nuanced view of the model's strengths and weaknesses.\n", + "# 5. Comparative Analysis: By applying the function to different datasets and prediction sources (GPT-4, model predictions), it enables direct comparison of performance across different approaches.\n" + ] + }, + { + "cell_type": "markdown", + "id": "6d98779b-ff8f-4ec6-b22f-d05b52a6397c", + "metadata": {}, + "source": [ + "# =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-" + ] + }, + { + "cell_type": "markdown", + "id": "c892d5c0-fb04-43c6-9c78-5c5d6b859818", + "metadata": {}, + "source": [ + "\n", + "\n", + "```markdown\n", + "## df_final TrialGPT-Criterion-Annotations Classification Report\n", + "\n", + "```\n", + " precision recall f1-score support\n", + "\n", + " excluded 0.60 1.00 0.75 9\n", + " included 0.97 0.90 0.93 149\n", + " not applicable 0.48 0.98 0.65 55\n", + "not enough information 0.88 0.88 0.88 285\n", + " not excluded 0.97 0.86 0.91 476\n", + " not included 0.72 0.78 0.75 23\n", + "\n", + " accuracy 0.88 997\n", + " macro avg 0.77 0.90 0.81 997\n", + " weighted avg 0.91 0.88 0.89 997\n", + "```\n", + "\n", + "## Overall Performance\n", + "\n", + "df_final Overall F1 Score (weighted): 0.8870\n", + "\n", + "## True Label Distribution\n", + "\n", + "| expert_eligibility | proportion |\n", + "|------------------------|------------|\n", + "| not excluded | 0.477432 |\n", + "| not enough information | 0.285858 |\n", + "| included | 0.149448 |\n", + "| not applicable | 0.055165 |\n", + "| not included | 0.023069 |\n", + "| excluded | 0.009027 |\n", + "\n", + "## Prediction Distribution\n", + "\n", + "| gpt4_eligibility | proportion |\n", + "|------------------------|------------|\n", + "| not excluded | 0.424273 |\n", + "| not enough information | 0.284855 |\n", + "| included | 0.138415 |\n", + "| not applicable | 0.112337 |\n", + "| not included | 0.025075 |\n", + "| excluded | 0.015045 |\n", + "```\n", + "\n", + "\n", + "\n", + "Absolutely. This analysis is comparing the GPT-4-Turbo predictions (which were baked into the TrialGPT-Criterion-Annotations dataset) against the expert annotations in the same dataset. Let's break down what these results mean in detail:\n", + "\n", + "1. Dataset Context:\n", + " - This is analyzing df_final, which contains the TrialGPT-Criterion-Annotations data.\n", + " - The comparison is between 'expert_eligibility' (true labels) and 'gpt4_eligibility' (GPT-4-Turbo predictions that were included in the original dataset).\n", + "\n", + "2. Classification Report:\n", + "\n", + " a) Excluded:\n", + " - Perfect recall (1.00) but lower precision (0.60), indicating GPT-4-Turbo correctly identified all truly excluded cases but also incorrectly labeled some non-excluded cases as excluded.\n", + " - Only 9 cases, so this high performance might not be representative.\n", + "\n", + " b) Included:\n", + " - Very high precision (0.97) and recall (0.90), showing strong performance in identifying included cases.\n", + "\n", + " c) Not Applicable:\n", + " - High recall (0.98) but low precision (0.48), suggesting GPT-4-Turbo overclassified cases as not applicable.\n", + "\n", + " d) Not Enough Information:\n", + " - Balanced performance with both precision and recall at 0.88.\n", + "\n", + " e) Not Excluded:\n", + " - High precision (0.97) but slightly lower recall (0.86), indicating some not excluded cases were misclassified.\n", + "\n", + " f) Not Included:\n", + " - Moderate performance with precision at 0.72 and recall at 0.78.\n", + "\n", + "3. Overall Metrics:\n", + " - Accuracy: 0.88 (88% of all predictions were correct)\n", + " - Weighted F1 Score: 0.8870 (a strong overall performance)\n", + "\n", + "4. Label Distribution:\n", + " - True Distribution:\n", + " * 'not excluded' is the most common label (47.7%)\n", + " * 'excluded' is the least common (0.9%)\n", + " - Predicted Distribution:\n", + " * Generally aligns well with the true distribution\n", + " * Slight overestimation of 'not applicable' cases (11.2% predicted vs 5.5% true)\n", + "\n", + "5. Key Observations:\n", + " - The high overall F1 score (0.8870) suggests very strong performance by GPT-4-Turbo.\n", + " - Performance is particularly good for the most common classes ('not excluded', 'not enough information', 'included').\n", + " - There's a tendency to overpredict 'not applicable' cases.\n", + " - The model performs well even on less common classes like 'not included'.\n", + "\n", + "6. Important Considerations:\n", + " - These results are for GPT-4-Turbo predictions that were already part of the annotation set, which could potentially lead to an overly optimistic assessment.\n", + " - The close alignment between predicted and true distributions might be partly due to this integration of GPT-4-Turbo predictions into the dataset.\n", + " - The very high performance on the 'excluded' class, despite its rarity, is particularly noteworthy and might warrant further investigation.\n", + "\n", + "7. Potential Implications:\n", + " - While the performance appears excellent, it's crucial to remember that these GPT-4-Turbo predictions were already part of the dataset, which could inflate the apparent performance.\n", + " - This high performance sets a benchmark against which other models or versions can be compared.\n", + " - The slight discrepancies in label distribution provide insights into where GPT-4-Turbo might be biased or where human experts might disagree with the model.\n", + "\n", + "In conclusion, while these results show exceptional performance by GPT-4-Turbo, it's important to approach them with some caution given that the GPT-4-Turbo predictions were already integrated into the annotation set. This integration could lead to an artificially high alignment between predictions and expert labels. For a more robust evaluation, it would be valuable to test GPT-4-Turbo on a completely independent dataset or to compare these results with those from other models or annotation sources." + ] + }, + { + "attachments": {}, + "cell_type": "markdown", + "id": "499a1264-9b55-41ef-b61d-06fea22d4628", + "metadata": {}, + "source": [ + "```markdown\n", + "## df_merged (predicted) gpt-4o Classification Report:\n", + "\n", + "```\n", + " precision recall f1-score support\n", + "\n", + " excluded 0.33 0.75 0.46 8\n", + " included 0.83 0.85 0.84 123\n", + " not applicable 0.77 0.51 0.61 53\n", + "not enough information 0.46 0.71 0.56 254\n", + " not excluded 0.84 0.56 0.67 426\n", + " not included 0.23 0.38 0.29 16\n", + "\n", + " accuracy 0.64 880\n", + " macro avg 0.58 0.62 0.57 880\n", + " weighted avg 0.71 0.64 0.65 880\n", + "```\n", + "\n", + "## Overall Performance\n", + "\n", + "df_merged (predicted) Overall F1 Score (weighted): 0.6503\n", + "\n", + "## True Label Distribution\n", + "\n", + "| expert_eligibility | proportion |\n", + "|------------------------|------------|\n", + "| not excluded | 0.484091 |\n", + "| not enough information | 0.288636 |\n", + "| included | 0.139773 |\n", + "| not applicable | 0.060227 |\n", + "| not included | 0.018182 |\n", + "| excluded | 0.009091 |\n", + "\n", + "## Prediction Distribution\n", + "\n", + "| eligibility_label_predicted | proportion |\n", + "|-----------------------------|------------|\n", + "| not enough information | 0.445455 |\n", + "| not excluded | 0.321591 |\n", + "| included | 0.143182 |\n", + "| not applicable | 0.039773 |\n", + "| not included | 0.029545 |\n", + "| excluded | 0.020455 |\n", + "```\n", + "\n", + "\n", + "Certainly. These results are from your custom GPT-4o model (released in May 2024), which is an improved version over GPT-4-Turbo (OpenAI announced GPT-4 Turbo in November 2023), along with enhanced prompting techniques you developed. Let's break down these results in detail:\n", + "\n", + "1. Dataset Context:\n", + " - This analysis is on df_merged, comparing 'expert_eligibility' (true labels) with 'eligibility_label_predicted' (predictions from your GPT-4o model).\n", + "\n", + "2. Classification Report:\n", + "\n", + " a) Excluded:\n", + " - Low precision (0.33) but high recall (0.75), indicating the model tends to overpredict this category.\n", + " - Only 8 cases, so these metrics might not be very reliable.\n", + "\n", + " b) Included:\n", + " - Strong performance with precision at 0.83 and recall at 0.85.\n", + "\n", + " c) Not Applicable:\n", + " - Good precision (0.77) but lower recall (0.51), suggesting the model misses some 'not applicable' cases.\n", + "\n", + " d) Not Enough Information:\n", + " - Low precision (0.46) but higher recall (0.71), indicating a tendency to overuse this label.\n", + "\n", + " e) Not Excluded:\n", + " - High precision (0.84) but lower recall (0.56), suggesting the model misses many 'not excluded' cases.\n", + "\n", + " f) Not Included:\n", + " - Poor performance with low precision (0.23) and recall (0.38).\n", + "\n", + "3. Overall Metrics:\n", + " - Accuracy: 0.64 (64% of all predictions were correct)\n", + " - Weighted F1 Score: 0.6503\n", + "\n", + "4. Label Distribution:\n", + " - True Distribution:\n", + " * Similar to the previous analysis, with 'not excluded' being most common (48.4%)\n", + " - Predicted Distribution:\n", + " * Overestimates 'not enough information' (44.5% predicted vs 28.9% true)\n", + " * Underestimates 'not excluded' (32.2% predicted vs 48.4% true)\n", + "\n", + "5. Key Observations:\n", + " - The overall performance (F1 score of 0.6503) is notably lower than the GPT-4-turbo results in the previous analysis.\n", + " - The model performs best on 'included' cases, which is crucial for clinical trial recruitment.\n", + " - There's a significant tendency to overpredict 'not enough information' cases.\n", + " - Performance on rare classes ('excluded', 'not included') is poor, likely due to class imbalance.\n", + "\n", + "6. Comparison to Previous Results:\n", + " - This model's performance is more modest compared to the GPT-4 results in the TrialGPT-Criterion-Annotations dataset.\n", + " - The distribution of predictions differs more from the true distribution, especially for 'not enough information' and 'not excluded' categories.\n", + "\n", + "7. Implications and Insights:\n", + " - The lower performance compared to the previous results suggests that:\n", + " a) The task is genuinely challenging, and the high performance in the annotation set might have been optimistic.\n", + " b) There might be differences in how your model and the original GPT-4 approach the task.\n", + " - The tendency to predict 'not enough information' could indicate a more cautious approach by your model.\n", + " - The model struggles with less common categories, which is a common challenge in imbalanced datasets.\n", + "\n", + "8. Potential Areas for Improvement:\n", + " - Addressing class imbalance, particularly for 'excluded' and 'not included' categories.\n", + " - Refining the model's ability to distinguish between 'not enough information' and other categories.\n", + " - Improving recall for 'not excluded' cases, which form a large portion of the dataset.\n", + "\n", + "9. Strengths of Your Approach:\n", + " - Despite lower overall metrics, your model shows strong performance on 'included' cases, which is crucial for clinical trial recruitment.\n", + " - The more balanced performance across categories (compared to the extreme high performance on 'excluded' in the previous results) might indicate a more realistic and generalizable model." + ] + }, + { + "cell_type": "markdown", + "id": "5c4b7028-d1a7-4e7f-8abc-f1edcfaa6c6d", + "metadata": {}, + "source": [ + "Here's the properly formatted markdown for the provided data:\n", + "\n", + "```markdown\n", + "## df_merged (predicted) llama70b Classification Report\n", + "\n", + "```\n", + " precision recall f1-score support\n", + "\n", + " excluded 0.19 0.75 0.31 8\n", + " included 0.65 0.88 0.75 115\n", + " not applicable 0.54 0.27 0.36 52\n", + "not enough information 0.65 0.38 0.48 224\n", + " not excluded 0.81 0.88 0.84 427\n", + " not included 0.14 0.31 0.20 16\n", + "\n", + " accuracy 0.70 842\n", + " macro avg 0.50 0.58 0.49 842\n", + " weighted avg 0.71 0.70 0.69 842\n", + "```\n", + "\n", + "## Overall Performance\n", + "\n", + "df_merged (predicted) Overall F1 Score (weighted): 0.6869\n", + "\n", + "## True Label Distribution\n", + "\n", + "| expert_eligibility | proportion |\n", + "|------------------------|------------|\n", + "| not excluded | 0.507126 |\n", + "| not enough information | 0.266033 |\n", + "| included | 0.136580 |\n", + "| not applicable | 0.061758 |\n", + "| not included | 0.019002 |\n", + "| excluded | 0.009501 |\n", + "\n", + "## Prediction Distribution\n", + "\n", + "| eligibility_label_predicted | proportion |\n", + "|-----------------------------|------------|\n", + "| not excluded | 0.549881 |\n", + "| included | 0.184086 |\n", + "| not enough information | 0.156770 |\n", + "| not included | 0.041568 |\n", + "| excluded | 0.036817 |\n", + "| not applicable | 0.030879 |\n", + "```\n", + "\n", + "Certainly! Let's analyze these results for the llama70b model in detail:\n", + "\n", + "Key observations and analysis:\n", + "\n", + "1. Overall Performance:\n", + " - Weighted F1 Score: 0.6869, which is better than your GPT-4o model (0.6503) but still significantly lower than the GPT-4 results (0.8905).\n", + "\n", + "2. Classification Report:\n", + " a) Excluded:\n", + " - Low precision (0.19) but high recall (0.75), indicating overclassification of this rare category.\n", + " b) Included:\n", + " - Good performance with precision 0.65 and high recall 0.88.\n", + " c) Not Applicable:\n", + " - Moderate precision (0.54) but low recall (0.27), suggesting underclassification.\n", + " d) Not Enough Information:\n", + " - Moderate precision (0.65) and low recall (0.38), indicating underuse of this label.\n", + " e) Not Excluded:\n", + " - Strong performance with high precision (0.81) and recall (0.88).\n", + " f) Not Included:\n", + " - Poor performance with very low precision (0.14) and low recall (0.31).\n", + "\n", + "3. Label Distribution:\n", + " - True Distribution: Dominated by 'not excluded' (50.7%) and 'not enough information' (26.6%).\n", + " - Predicted Distribution: Overpredicts 'not excluded' (55.0%) and underpredicts 'not enough information' (15.7%).\n", + "\n", + "4. Key Insights:\n", + " - The model performs best on the most common category ('not excluded') and struggles with rare categories.\n", + " - There's a tendency to overpredict 'not excluded' and underpredict 'not enough information'.\n", + " - Performance on 'included' cases is good, which is crucial for clinical trial recruitment.\n", + "\n", + "5. Comparison to Other Models:\n", + " - llama70b outperforms your GPT-4o model but falls short of the GPT-4 results in the original dataset.\n", + " - It shows a different error pattern compared to GPT-4o, with better performance on 'not excluded' but worse on 'not enough information'.\n", + "\n", + "6. Potential Areas for Improvement:\n", + " - Addressing class imbalance, especially for rare categories like 'excluded' and 'not included'.\n", + " - Improving the model's ability to identify 'not enough information' cases.\n", + " - Refining the classification of 'not applicable' cases to improve recall.\n", + "\n", + "7. Strengths of llama70b:\n", + " - Strong performance on the most common category ('not excluded').\n", + " - Good recall for 'included' cases, which is important for not missing potential trial participants.\n", + "\n", + "8. Limitations:\n", + " - Struggles with rare categories, which could lead to misclassifications in important edge cases.\n", + " - Tendency to overuse the 'not excluded' label, which might result in false positives.\n", + "\n", + "In conclusion, the llama70b model shows promising performance, particularly in its ability to handle the most common categories and identify included cases. However, it still faces challenges with rare categories and balancing between different labels. This performance suggests that while large language models like llama70b have strong potential in clinical trial eligibility assessment, there's still room for improvement, particularly in handling the nuances of less common cases and distinguishing between subtle categories like 'not enough information' and 'not excluded'." + ] + }, + { + "cell_type": "markdown", + "id": "4e5d3677-5751-4b30-963d-daeb8bb5d1e2", + "metadata": {}, + "source": [ + "\n", + "```markdown\n", + "## df_merged (GPT-4-turbo) Classification Report\n", + "\n", + "```\n", + " precision recall f1-score support\n", + "\n", + " excluded 0.62 1.00 0.76 8\n", + " included 0.97 0.92 0.95 123\n", + " not applicable 0.51 0.98 0.67 53\n", + "not enough information 0.89 0.88 0.88 254\n", + " not excluded 0.97 0.87 0.92 426\n", + " not included 0.65 0.69 0.67 16\n", + "\n", + " accuracy 0.88 880\n", + " macro avg 0.77 0.89 0.81 880\n", + " weighted avg 0.91 0.88 0.89 880\n", + "```\n", + "\n", + "## Overall Performance\n", + "\n", + "df_merged (GPT-4) Overall F1 Score (weighted): 0.8905\n", + "\n", + "## True Label Distribution\n", + "\n", + "| expert_eligibility | proportion |\n", + "|------------------------|------------|\n", + "| not excluded | 0.484091 |\n", + "| not enough information | 0.288636 |\n", + "| included | 0.139773 |\n", + "| not applicable | 0.060227 |\n", + "| not included | 0.018182 |\n", + "| excluded | 0.009091 |\n", + "\n", + "## Prediction Distribution\n", + "\n", + "| gpt4_eligibility | proportion |\n", + "|------------------------|------------|\n", + "| not excluded | 0.430682 |\n", + "| not enough information | 0.287500 |\n", + "| included | 0.131818 |\n", + "| not applicable | 0.115909 |\n", + "| not included | 0.019318 |\n", + "| excluded | 0.014773 |\n", + "```\n", + "\n", + "You've made an excellent observation here. Let's break this down and discuss its significance:\n", + "\n", + "1. Dataset Context:\n", + " - This analysis is on df_merged, comparing 'expert_eligibility' (true labels) with 'gpt4_eligibility' (GPT-4 predictions).\n", + " - Importantly, this is on the subset of 880 rows that remained after the inner join, down from the original 1054 rows.\n", + "\n", + "2. Performance Metrics:\n", + " - Overall F1 Score: 0.8905, which is slightly higher than the 0.8870 seen in the full df_final dataset.\n", + " - Accuracy: 0.88, matching the accuracy in the full dataset.\n", + "\n", + "3. Classification Report:\n", + " - The performance across all categories is very similar to what we saw in the full dataset.\n", + " - Notably high precision and recall for 'included', 'not excluded', and 'not enough information' categories.\n", + " - Perfect recall (1.00) for 'excluded', but with only 8 cases.\n", + "\n", + "4. Label Distributions:\n", + " - True label distribution is nearly identical to what we saw in the full dataset.\n", + " - Predicted distribution is also very close, with slight variations.\n", + "\n", + "5. Key Observations:\n", + " - Despite losing about 16.5% of the rows in the merging process, the performance metrics have slightly improved.\n", + " - The consistency in performance and distribution suggests that the lost rows were not significantly different in terms of difficulty or distribution from the retained rows.\n", + "\n", + "6. Implications:\n", + " - The improved performance on this subset indicates that the rows lost in the merge were not \"easy\" cases that artificially inflated the scores.\n", + " - If anything, the lost rows might have included some of the more challenging cases, as removing them led to a slight improvement in performance.\n", + "\n", + "7. Data Quality Insights:\n", + " - This result suggests that the data merging process, while reducing the dataset size, did not introduce a bias that favored easier cases.\n", + " - It provides confidence that the merged dataset is representative of the full dataset in terms of difficulty and distribution of cases.\n", + "\n", + "8. Comparison with Your Model:\n", + " - The stark difference in performance between this GPT-4 result (F1: 0.8905) and your GPT-4o model (F1: 0.6503) on the same subset of data becomes even more intriguing.\n", + " - It reinforces the notion that the high performance of GPT-4 in this dataset might be due to factors beyond just model capability, possibly including how it was integrated into the annotation process.\n", + "\n", + "9. Methodological Considerations:\n", + " - This result highlights the importance of careful data handling and analysis in machine learning projects.\n", + " - It demonstrates how data merging and filtering steps can impact results, and the importance of checking for unintended consequences of these processes.\n", + "\n", + "10. Future Directions:\n", + " - It might be worth investigating the characteristics of the ~174 rows that were lost in the merge. While they didn't negatively impact the GPT-4 performance, understanding why they were lost could provide insights into data quality or processing issues.\n", + " - The consistent high performance of GPT-4 across different subsets of the data suggests that it might be worthwhile to examine individual cases where your model disagrees with GPT-4, to understand the reasoning behind these differences.\n", + "\n", + "In conclusion, this analysis provides a valuable sanity check on your data processing steps and offers reassurance about the representativeness of your merged dataset. It also further emphasizes the exceptionally high performance of GPT-4 on this task, which contrasts sharply with your model's performance. This discrepancy continues to suggest that there might be some inherent bias or integration effect in how GPT-4's predictions were incorporated into the original dataset, making it a challenging benchmark to compare against directly." + ] + }, + { + "cell_type": "code", + "execution_count": 36, + "id": "03ea3b6e-d146-4bf1-8457-74eb3db2844e", + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "Columns in the slimmed-down dataframe: ['patient_id', 'TODOremove', 'trial_id', 'criterion_type', 'criterion_number', 'brief_reasoning', 'sentence_ids', 'eligibility_label_predicted', 'criterion_text', 'annotation_id', 'note', 'gpt4_explanation', 'explanation_correctness', 'gpt4_sentences', 'expert_sentences', 'gpt4_eligibility', 'expert_eligibility', 'training']\n", + "Rows where predicted != expert: 335\n", + "Rows where predicted != GPT-4: 365\n", + "Rows where expert != GPT-4: 103\n" + ] + } + ], + "source": [ + "# Remove specified columns from df_merged to create a slimmed-down version\n", + "columns_to_drop = ['criterion_text_clean', 'text', 'score', 'trial_title', \n", + " 'criterion_text_final', 'num_trials', 'num_distinct_criteria']\n", + "\n", + "df_merged_slim = df_merged.drop(columns=columns_to_drop)\n", + "\n", + "# Create three comparison tables using the slimmed-down df_merged_slim\n", + "\n", + "# Table 1: Identify rows where the model's predictions differ from expert labels\n", + "df_pred_vs_expert = df_merged_slim[df_merged_slim['eligibility_label_predicted'] != df_merged_slim['expert_eligibility']]\n", + "\n", + "# Table 2: Identify rows where the model's predictions differ from GPT-4 predictions\n", + "df_pred_vs_gpt4 = df_merged_slim[df_merged_slim['eligibility_label_predicted'] != df_merged_slim['gpt4_eligibility']]\n", + "\n", + "# Table 3: Identify rows where expert labels differ from GPT-4 predictions\n", + "df_expert_vs_gpt4 = df_merged_slim[df_merged_slim['expert_eligibility'] != df_merged_slim['gpt4_eligibility']]\n", + "\n", + "# Print summary information about the resulting dataframes\n", + "print(f\"Columns in the slimmed-down dataframe: {df_merged_slim.columns.tolist()}\")\n", + "print(f\"Rows where predicted != expert: {len(df_pred_vs_expert)}\")\n", + "print(f\"Rows where predicted != GPT-4: {len(df_pred_vs_gpt4)}\")\n", + "print(f\"Rows where expert != GPT-4: {len(df_expert_vs_gpt4)}\")\n", + "\n", + "# This final section of code is crucial for several reasons:\n", + "\n", + "# 1. Data Simplification:\n", + "# - It removes unnecessary columns, focusing the analysis on the most relevant information.\n", + "# - This simplification can improve processing speed and make the data easier to work with.\n", + "\n", + "# 2. Comparative Analysis:\n", + "# - It creates three distinct dataframes, each highlighting a different type of disagreement:\n", + "# a) Your model vs. expert labels\n", + "# b) Your model vs. GPT-4 predictions\n", + "# c) Expert labels vs. GPT-4 predictions\n", + "# - This allows for a nuanced understanding of where and how the different assessments diverge.\n", + "\n", + "# 3. Error Analysis Preparation:\n", + "# - By isolating the cases where there are disagreements, it sets the stage for detailed error analysis.\n", + "# - This is crucial for understanding the strengths and weaknesses of each approach (your model, GPT-4, and expert labeling).\n", + "\n", + "# 4. Quantification of Disagreements:\n", + "# - Printing the number of rows in each comparison dataframe provides a quick quantitative measure of how often each type of disagreement occurs.\n", + "\n", + "# 5. Model Evaluation:\n", + "# - Comparing your model's predictions against both expert labels and GPT-4 predictions allows for a multi-faceted evaluation of its performance.\n", + "\n", + "# 6. Expert vs. AI Comparison:\n", + "# - The comparison between expert labels and GPT-4 predictions (df_expert_vs_gpt4) is particularly interesting, as it highlights cases where human expertise and advanced AI disagree.\n", + "\n", + "# 7. Data Integrity Check:\n", + "# - This process can also serve as a final check on data integrity, ensuring that all expected columns are present and contain the anticipated types of data.\n", + "\n", + "# 8. Foundation for Further Analysis:\n", + "# - These comparison dataframes form the basis for more detailed investigations, such as:\n", + "# - Analyzing patterns in the types of criteria where disagreements occur\n", + "# - Identifying potential biases in any of the labeling methods\n", + "# - Pinpointing areas where your model might need improvement\n" + ] + }, + { + "cell_type": "code", + "execution_count": 37, + "id": "24dc1449-9199-42d9-87b2-eee71aed4762", + "metadata": {}, + "outputs": [ + { + "data": { + "text/html": [ + "
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20sigir-201410NCT01397994exclusion15The patient has no geographical inaccessibility for treatment or follow-up.[8]not excludedGeographical inaccessibility for treatment or follow-up evaluations200. A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life.\\n1. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, ...The patient note does not provide information about the patient's geographical accessibility for treatment or follow-up evaluations.Incorrect[][8]not enough informationnot excludedFalse
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0sigir-201410NCT01397994inclusion0The patient has episodic chest pain but no evidence of chronic stable angina or abnormal Exercise Myocardial Perfusion Spect Scan.[0, 1]not includedPatients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes.00. A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life.\\n1. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, ...The patient note does not provide direct evidence of the patient having chronic stable angina or having undergone an Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. However, the patient does present with symptoms of chest pain, which could be i...Correct[0, 1, 2][0, 1, 2]not enough informationnot enough informationTrue
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" + ], + "text/plain": [ + " patient_id TODOremove trial_id criterion_type criterion_number \\\n", + "0 sigir-20141 0 NCT01397994 inclusion 0 \n", + ".. ... ... ... ... ... \n", + "\n", + " brief_reasoning \\\n", + "0 The patient has episodic chest pain but no evidence of chronic stable angina or abnormal Exercise Myocardial Perfusion Spect Scan. \n", + ".. ... \n", + "\n", + " sentence_ids eligibility_label_predicted \\\n", + "0 [0, 1] not included \n", + ".. ... ... \n", + "\n", + " criterion_text \\\n", + "0 Patients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. \n", + ".. ... \n", + "\n", + " annotation_id \\\n", + "0 0 \n", + ".. ... \n", + "\n", + " note \\\n", + "0 0. A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life.\\n1. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, ... \n", + ".. ... \n", + "\n", + " gpt4_explanation \\\n", + "0 The patient note does not provide direct evidence of the patient having chronic stable angina or having undergone an Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. However, the patient does present with symptoms of chest pain, which could be i... \n", + ".. ... \n", + "\n", + " explanation_correctness gpt4_sentences expert_sentences \\\n", + "0 Correct [0, 1, 2] [0, 1, 2] \n", + ".. ... ... ... \n", + "\n", + " gpt4_eligibility expert_eligibility training \n", + "0 not enough information not enough information True \n", + ".. ... ... ... \n", + "\n", + "[335 rows x 18 columns]" + ] + }, + "execution_count": 38, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "df_pred_vs_expert" + ] + }, + { + "cell_type": "code", + "execution_count": 39, + "id": "c5d297f4-60e6-46f0-a2a2-a0d2f96f46c1", + "metadata": {}, + "outputs": [ + { + "data": { + "text/html": [ + "
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0sigir-201410NCT01397994inclusion0The patient has episodic chest pain but no evidence of chronic stable angina or abnormal Exercise Myocardial Perfusion Spect Scan.[0, 1]not includedPatients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes.00. A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life.\\n1. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, ...The patient note does not provide direct evidence of the patient having chronic stable angina or having undergone an Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. However, the patient does present with symptoms of chest pain, which could be i...Correct[0, 1, 2][0, 1, 2]not enough informationnot enough informationTrue
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" + ], + "text/plain": [ + " patient_id TODOremove trial_id criterion_type criterion_number \\\n", + "0 sigir-20141 0 NCT01397994 inclusion 0 \n", + ".. ... ... ... ... ... \n", + "\n", + " brief_reasoning \\\n", + "0 The patient has episodic chest pain but no evidence of chronic stable angina or abnormal Exercise Myocardial Perfusion Spect Scan. \n", + ".. ... \n", + "\n", + " sentence_ids eligibility_label_predicted \\\n", + "0 [0, 1] not included \n", + ".. ... ... \n", + "\n", + " criterion_text \\\n", + "0 Patients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. \n", + ".. ... \n", + "\n", + " annotation_id \\\n", + "0 0 \n", + ".. ... \n", + "\n", + " note \\\n", + "0 0. A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life.\\n1. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, ... \n", + ".. ... \n", + "\n", + " gpt4_explanation \\\n", + "0 The patient note does not provide direct evidence of the patient having chronic stable angina or having undergone an Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. However, the patient does present with symptoms of chest pain, which could be i... \n", + ".. ... \n", + "\n", + " explanation_correctness gpt4_sentences expert_sentences \\\n", + "0 Correct [0, 1, 2] [0, 1, 2] \n", + ".. ... ... ... \n", + "\n", + " gpt4_eligibility expert_eligibility training \n", + "0 not enough information not enough information True \n", + ".. ... ... ... \n", + "\n", + "[365 rows x 18 columns]" + ] + }, + "execution_count": 39, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "df_pred_vs_gpt4" + ] + } + ], + "metadata": { + "kernelspec": { + "display_name": "Python 3 (ipykernel)", + "language": "python", + "name": "python3" + }, + "language_info": { + "codemirror_mode": { + "name": "ipython", + "version": 3 + }, + "file_extension": ".py", + "mimetype": "text/x-python", + "name": "python", + "nbconvert_exporter": "python", + "pygments_lexer": "ipython3", + "version": "3.12.8" + } + }, + "nbformat": 4, + "nbformat_minor": 5 +} diff --git a/clean.sh b/clean.sh new file mode 100644 index 0000000..f48d3a8 --- /dev/null +++ b/clean.sh @@ -0,0 +1,10 @@ +#!/bin/bash + +# Remove the 'results' directory and its contents, verbosely +rm -rfv results + +# Create a new 'results' directory +mkdir results + +# Copy __init__.py from results_cuwtf to results, verbosely +touch results/__init__.py \ No newline at end of file diff --git a/common/__init__.py b/common/__init__.py new file mode 100644 index 0000000..ac30b45 --- /dev/null +++ b/common/__init__.py @@ -0,0 +1,18 @@ +# common/__init__.py + +from .utils import ( + load_corpus_details, + generate_keywords_gpt, + generate_keywords_llama, + setup_llama_pipeline, + setup_model, + generate_response +) + +__all__ = ['load_corpus_details', + 'generate_keywords_gpt', + 'generate_keywords_llama', + 'setup_llama_pipeline', + 'setup_model', + 'generate_response' + ] \ No newline at end of file diff --git a/common/utils.py b/common/utils.py new file mode 100644 index 0000000..08859a8 --- /dev/null +++ b/common/utils.py @@ -0,0 +1,228 @@ +import json +import torch +from transformers import AutoModelForCausalLM, AutoTokenizer, BitsAndBytesConfig, pipeline as hf_pipeline +from openai import OpenAI + +def load_corpus_details(corpus_path: str) -> dict: + """ + Load corpus details into a dictionary for quick lookup. + + Args: + corpus_path (str): Path to the corpus JSONL file. + + Returns: + dict: A dictionary containing corpus details, keyed by NCT ID. + """ + corpus_details = {} + with open(corpus_path, "r") as f: + for line in f: + entry = json.loads(line) + nct_id = entry["_id"] + metadata = entry.get("metadata", {}) + corpus_details[nct_id] = { + "brief_title": metadata.get("brief_title", entry.get("title", "")), + "phase": metadata.get("phase", ""), + "drugs": metadata.get("drugs", ""), + "drugs_list": metadata.get("drugs_list", []), + "diseases": metadata.get("diseases", ""), + "diseases_list": metadata.get("diseases_list", []), + "enrollment": metadata.get("enrollment", ""), + "inclusion_criteria": metadata.get("inclusion_criteria", ""), + "exclusion_criteria": metadata.get("exclusion_criteria", ""), + "brief_summary": metadata.get("brief_summary", entry.get("text", "")), + "NCTID": nct_id + } + return corpus_details + +def generate_keywords_gpt(client, model, messages): + """ + Generate keywords using GPT models. + + Args: + client (OpenAI): The OpenAI client. + model (str): The GPT model to use. + messages (list): The input messages for the model. + + Returns: + str: The generated keywords as a JSON string. + """ + response = client.chat.completions.create( + model=model, + messages=messages, + temperature=0, + ) + return response.choices[0].message.content.strip("`").strip("json") + +def generate_keywords_llama(pipeline, messages): + """ + Generate keywords using Llama models. + + Args: + pipeline (transformers.Pipeline): The Llama model pipeline. + messages (list): The input messages for the model. + + Returns: + str: The generated keywords as a JSON string. + """ + response = pipeline(messages, + max_new_tokens=2856, + do_sample=False, + temperature=None, + top_p=None) + return response[0]['generated_text'].strip("`") + +def create_llama_device_map(num_gpus, first_weight=1.0, last_weight=1.0): + """ + Create a device map for distributing Llama model layers across multiple GPUs. + + This function calculates how to distribute the model layers across the available GPUs, + with the option to assign different weights to the first and last GPUs. + + Args: + num_gpus (int): The number of GPUs to use. Must be at least 2. + first_weight (float, optional): Weight for the first GPU. Defaults to 1.0. + last_weight (float, optional): Weight for the last GPU. Defaults to 1.0. + + Returns: + dict: A device map specifying which GPU each model component should be assigned to. + + Raises: + ValueError: If the number of GPUs is less than 2. + + Note: + The function assumes a total of 80 layers in the Llama model, with special handling + for the first and last layers, as well as additional components like embeddings and norms. + """ + if num_gpus < 2: + raise ValueError("Number of GPUs must be at least 2") + + # Calculate the number of layers to distribute + distributable_layers = 77 # 79 total layers minus the first and last layers + + # Calculate weights for middle GPUs + middle_gpus = num_gpus - 2 + middle_weight = (num_gpus - first_weight - last_weight) / middle_gpus if middle_gpus > 0 else 0 + + # Calculate layers per GPU + layers_per_gpu = [ + max(1, round(first_weight * distributable_layers / num_gpus)), # First GPU + *[max(1, round(middle_weight * distributable_layers / num_gpus)) for _ in range(middle_gpus)], # Middle GPUs + max(1, round(last_weight * distributable_layers / num_gpus)) # Last GPU + ] + + # Adjust to ensure total is correct + while sum(layers_per_gpu) < distributable_layers: + layers_per_gpu[layers_per_gpu.index(min(layers_per_gpu))] += 1 + while sum(layers_per_gpu) > distributable_layers: + layers_per_gpu[layers_per_gpu.index(max(layers_per_gpu))] -= 1 + + # Create the device map + device_map = { + "model.embed_tokens": 0, + "model.layers.0": 0, + "model.layers.1": 0, + } + + current_layer = 2 + for gpu, layer_count in enumerate(layers_per_gpu): + for _ in range(layer_count): + if current_layer < 78: + device_map[f"model.layers.{current_layer}"] = gpu + current_layer += 1 + + # Assign the last layers and components to the last GPU + last_gpu = num_gpus - 1 + device_map.update({ + "model.layers.78": last_gpu, + "model.layers.79": last_gpu, + "model.norm": last_gpu, + "model.rotary_emb": last_gpu, + "lm_head": last_gpu + }) + + return device_map + + +def setup_llama_pipeline(checkpoint_dir, use_quantization, num_gpus): + """ + Set up the Llama model pipeline for text generation. + + This function configures and initializes a Llama model pipeline, optionally with + quantization and distributed across multiple GPUs. + + Args: + checkpoint_dir (str): The directory containing the model checkpoint. + use_quantization (bool): Whether to use 8-bit quantization. + num_gpus (int, optional): The number of GPUs to use for model distribution. + + Returns: + transformers.Pipeline: The configured Llama model pipeline for text generation. + + Note: + This function uses custom weights for the first and last GPUs in the device map + to optimize the distribution of model components. + """ + if use_quantization: + quantization_config = BitsAndBytesConfig(load_in_8bit=True) + else: + quantization_config = None + + #TODO: should expose these to argparse + first_weight = .85 #0.8 + last_weight = .93# 0.6 + + device_map = create_llama_device_map(int(num_gpus), first_weight, last_weight) + + llm_model = AutoModelForCausalLM.from_pretrained( + checkpoint_dir, + device_map=device_map, + torch_dtype=torch.bfloat16, + quantization_config=quantization_config + ) + tokenizer = AutoTokenizer.from_pretrained(checkpoint_dir) + pipeline = hf_pipeline( + "text-generation", + model=llm_model, + tokenizer=tokenizer, + device_map=device_map, + return_full_text=False + ) + return pipeline + +def setup_model(model_name, num_gpus, checkpoint_dir=None, use_quantization=False): + """ + Set up the model based on the model name. + + Args: + model_name (str): The name of the model to use. + checkpoint_dir (str, optional): The directory for Llama model checkpoints. + use_quantization (bool): Whether to use quantization for Llama models. + num_gpus (int, optional): The number of GPUs to use for model distribution. + + Returns: + tuple: (model_type, model_instance) + model_type is either 'gpt' or 'llama' + model_instance is either an OpenAI client or a Llama pipeline + """ + if model_name.startswith('gpt'): + return 'gpt', OpenAI() + else: + return 'llama', setup_llama_pipeline(checkpoint_dir, use_quantization, num_gpus) + +def generate_response(model_type, model_instance, messages, model_name=None): + """ + Generate a response using either GPT or Llama models. + + Args: + model_type (str): Either 'gpt' or 'llama'. + model_instance: Either an OpenAI client or a Llama pipeline. + messages (list): The input messages for the model. + model_name (str, optional): The specific GPT model name (for OpenAI models). + + Returns: + str: The generated response. + """ + if model_type == 'gpt': + return generate_keywords_gpt(model_instance, model_name, messages) + else: + return generate_keywords_llama(model_instance, messages) \ No newline at end of file diff --git a/dataset/sigir/id2queries.json b/dataset/sigir/id2queries.json deleted file mode 100644 index 2431c74..0000000 --- a/dataset/sigir/id2queries.json +++ /dev/null @@ -1,5306 +0,0 @@ -{ - "sigir-20141": { - "raw": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", - "gpt-4-turbo": { - "summary": "A 58-year-old African-American woman with a history of hypertension and obesity presents with episodic pressing/burning anterior chest pain radiating to the back, accompanied by nausea, diaphoresis, and mild dyspnea. The pain is not increased on inspiration and started while walking. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. Physical examination is normal, and the EKG shows nonspecific changes.", - "conditions": [ - "Chest pain", - "Hypertension", - "Obesity", - "Nausea", - "Diaphoresis", - "Dyspnea", - "Non-specific EKG changes", - "Coronary artery disease", - "Angina", - "Acute coronary syndrome", - "Myocardial infarction", - "Cardiovascular disease risk factors", - "Exercise-induced angina", - "Radiating chest pain", - "Stable angina", - "Unstable angina", - "Heart disease", - "Stress-induced cardiomyopathy", - "Coronary heart disease", - "Cardiomyopathy", - "Heart failure", - "Peripheral artery disease", - "Atherosclerosis", - "Metabolic syndrome", - "Chronic obstructive pulmonary disease (COPD)", - "Pulmonary embolism", - "Gastroesophageal reflux disease (GERD)", - "Peptic ulcer disease", - "Panic disorder", - "Anxiety", - "Depression", - "Health disparities in African-American women" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 58-year-old African-American woman presenting with episodic chest pain, radiating to the back, accompanied by nausea, diaphoresis, and mild dyspnea. She has a history of hypertension and obesity. The EKG shows nonspecific changes.", - "conditions": [ - "Chest pain", - "Episodic chest pain", - "Radiating chest pain", - "Nausea", - "Diaphoresis", - "Mild dyspnea", - "Hypertension", - "Obesity", - "Nonspecific EKG changes", - "Angina", - "Coronary artery disease", - "Myocardial infarction", - "Heart disease", - "African-American", - "Pressing chest pain", - "Burning chest pain", - "Walking-induced chest pain", - "Chest pain radiating to the back", - "Chest pain with nausea", - "Chest pain with diaphoresis", - "Chest pain with mild dyspnea", - "Hypertensive patient with chest pain", - "Obese patient with chest pain", - "Chest pain in a non-smoker", - "Chest pain without diabetes", - "Chest pain without hypercholesterolemia", - "Chest pain without family history of heart disease", - "Chest pain with normal physical examination", - "Chest pain with nonspecific EKG changes", - "Episodic chest pain in a 58-year-old woman", - "Chest pain in an African-American woman", - "Chest pain with no medication use" - ] - }, - "human_summary": "58-year-old woman with hypertension and obesity presents with exercise-related episodic chest pain radiating to the back.", - "Clinician_A": [ - "Firstline management of new onset ACS in African-American Women", - "Firstline management of new onset ACS in Women", - "Firstline management of new onset ACS", - "Firstline management of new onset ACS in the obese" - ], - "Clinician_B": [ - "Obesity ACS", - "Obesity IHD", - "ACS", - "chest pain trial", - "hypertension ACS", - "Hypertension IHD" - ], - "Clinician_C": [ - "Clinical Trial Chest Pain Hypertension Obesity", - "Clinical Trial Chest Pain Burning Back pain nausea sweating" - ], - "Clinician_D": [ - "angina beta blocker trial", - "angina calcium channel blocker trial", - "angina nitrate trial", - "stable angina beta blocker trial", - "stable angina calcium channel blocker trial", - "stable angina nitrate trial" - ] - }, - "sigir-201410": { - "raw": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", - "gpt-4-turbo": { - "summary": "A 67-year-old woman is experiencing complications following cardiac catheterization via the right femoral artery, presenting with a cool right foot, a pulsatile mass in her right groin, loss of distal pulses, and a bruit over the catheterization site.", - "conditions": [ - "Cardiac catheterization complications", - "Femoral artery pseudoaneurysm", - "Loss of distal pulses", - "Peripheral artery disease", - "Cool extremities", - "Groin mass", - "Vascular bruit", - "Femoral artery occlusion", - "Ischemia", - "Peripheral vascular disorders", - "Arterial insufficiency", - "Atherosclerosis", - "Vascular surgery", - "Interventional radiology", - "Cardiovascular diseases", - "Vascular graft occlusion", - "Endovascular procedures complications", - "Angioplasty", - "Stent placement", - "Vascular stenosis", - "Vascular interventions", - "Critical limb ischemia", - "Acute limb ischemia", - "Peripheral arterial disease", - "Vascular ultrasound", - "Computed tomography angiography (CTA)", - "Magnetic resonance angiography (MRA)", - "Anticoagulation therapy", - "Antiplatelet therapy", - "Thrombolytic therapy", - "Vasodilator therapy", - "Blood flow restoration" - ] - }, - "gpt-35-turbo": { - "summary": "The main medical problems of the patient are a cool right foot, pulsatile mass in the right groin with loss of distal pulses, and a bruit over the point of femoral artery entry.", - "conditions": [ - "Peripheral arterial disease", - "Femoral artery occlusion", - "Arterial embolism", - "Arterial thrombosis", - "Atherosclerosis", - "Vascular insufficiency", - "Peripheral vascular disease", - "Arterial occlusion", - "Arterial stenosis", - "Arterial blockage", - "Vascular occlusion", - "Vascular blockage", - "Vascular thrombosis", - "Vascular embolism", - "Vascular insufficiency of lower extremity", - "Lower extremity ischemia", - "Lower limb ischemia", - "Peripheral artery occlusion", - "Peripheral artery stenosis", - "Peripheral artery blockage", - "Peripheral vascular occlusion", - "Peripheral vascular blockage", - "Peripheral vascular thrombosis", - "Peripheral vascular embolism", - "Peripheral vascular insufficiency", - "Femoral artery occlusion with ischemia", - "Femoral artery stenosis with ischemia", - "Femoral artery blockage with ischemia", - "Femoral vascular occlusion with ischemia", - "Femoral vascular blockage with ischemia", - "Femoral vascular thrombosis with ischemia", - "Femoral vascular embolism with ischemia", - "Femoral vascular insufficiency with ischemia" - ] - }, - "human_summary": "67-year-old woman status post cardiac catheterization via right femoral artery, now with a cool, pulseless right foot and right femoral bruit.", - "Clinician_B": [ - "femoral catheterization", - "femoral catheterisation ischemic" - ], - "Clinician_C": [ - "Clinical Trial Cardiac catherisation Femoral artery cool foot", - "Cinical Trial Cardiac catherisation Femoral Pulsing mass groin no pulses" - ], - "Clinician_A": [ - "Prognositc factors for ischaemic events of the lower limb post femoral artery catheterisation", - "Surgical complications associated with femroal artery catherterisation" - ], - "Clinician_D": [ - "arterial thrombosis clinical trial" - ] - }, - "sigir-201411": { - "raw": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", - "gpt-4-turbo": { - "summary": "A 40-year-old woman presents with excruciating pain in her right arm without prior trauma, exhibiting symptoms of paleness, moderate discomfort, tachypnea, tachycardia, normal body temperature, and hypotension. There is no discoloration or movement limitation in the affected arm.", - "conditions": [ - "Acute arm pain", - "Tachypnea", - "Tachycardia", - "Hypotension", - "Non-traumatic arm pain", - "Acute pain management", - "Pain in right arm", - "Paleness", - "Moderate discomfort", - "Systemic response to pain", - "Vital signs abnormality", - "Acute onset of arm pain", - "Cardiovascular symptoms", - "Respiratory symptoms", - "Pain assessment", - "Pain control", - "Emergency care", - "Acute care", - "Non-traumatic pain management", - "Stress response", - "Hemodynamic instability", - "Analgesia", - "Unexplained pain", - "Acute non-traumatic pain", - "Emergency room care", - "Observational studies on acute pain", - "Clinical trials on pain management", - "Interventional studies on non-traumatic pain", - "Tachycardia management", - "Tachypnea management", - "Hypotension treatment", - "Acute pain in adults" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 40-year-old woman presenting with excruciating pain in her right arm, pale appearance, tachypnea, tachycardia, and hypotension.", - "conditions": [ - "Acute limb ischemia", - "Compartment syndrome", - "Thromboembolism", - "Peripheral artery disease", - "Arterial dissection", - "Vascular injury", - "Thrombosis", - "Deep vein thrombosis", - "Radial artery occlusion", - "Brachial artery occlusion", - "Raynaud's phenomenon", - "Thoracic outlet syndrome", - "Vasculitis", - "Thrombangiitis obliterans", - "Arterial embolism", - "Arterial thrombosis", - "Arterial occlusion", - "Arterial insufficiency", - "Arterial stenosis", - "Arterial aneurysm", - "Arterial rupture", - "Arterial inflammation", - "Arterial obstruction", - "Arterial spasm", - "Arterial injury", - "Arterial calcification", - "Arterial malformation", - "Arterial bleeding", - "Arterial infection", - "Arterial abnormality", - "Arterial disorder", - "Arterial pain", - "Arterial swelling" - ] - }, - "human_summary": "40-year-old woman with severe right arm pain and hypotension. She has no history of trauma and right arm exam reveals no significant findings.", - "Clinician_C": [ - "Clinical Trial Arm Pain Right" - ], - "Clinician_A": [ - "Silent signs of myocardial infarction in women", - "Signs of stress in the Emergency department" - ], - "Clinician_D": [ - "arm pain hemodynamic shock clinical trial" - ] - }, - "sigir-201412": { - "raw": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", - "gpt-4-turbo": { - "summary": "A 25-year-old woman with prolonged fatigue, hair loss, voice change, weight gain, cold intolerance, and a prominent, soft, uniform anterior cervical mass at the midline.", - "conditions": [ - "Hypothyroidism", - "Thyroiditis", - "Goiter", - "Hashimoto's thyroiditis", - "Fatigue", - "Hair loss", - "Voice disorders", - "Weight gain", - "Cold intolerance", - "Thyroid nodule", - "Thyroid cancer", - "Autoimmune thyroiditis", - "Endocrine disorders", - "Metabolic disorders", - "Thyroid dysfunction", - "Chronic fatigue syndrome", - "Alopecia", - "Dysphonia", - "Obesity", - "Hormonal imbalance", - "Thyroid hormone resistance", - "Subclinical hypothyroidism", - "Euthyroid sick syndrome", - "Lymphocytic thyroiditis", - "Thyroid goiter", - "Non-toxic goiter", - "Toxic nodular goiter", - "Graves' disease", - "Papillary thyroid carcinoma", - "Follicular thyroid carcinoma", - "Medullary thyroid carcinoma", - "Anaplastic thyroid carcinoma" - ] - }, - "gpt-35-turbo": { - "summary": "The main medical problems of the patient include prolonged fatigue, hair loss, change in voice, weight gain, cold intolerance, and a prominent anterior cervical mass.", - "conditions": [ - "Thyroid cancer", - "Hypothyroidism", - "Goiter", - "Hashimoto's thyroiditis", - "Thyroid nodules", - "Thyroiditis", - "Thyroid dysfunction", - "Thyroid hormone resistance", - "Thyroid storm", - "Thyroid hormone deficiency", - "Thyroid hormone excess", - "Thyroid hormone resistance syndrome", - "Thyroid hormone receptor beta gene mutation", - "Thyroid hormone receptor alpha gene mutation", - "Thyroid hormone receptor beta gene defect", - "Thyroid hormone receptor alpha gene defect", - "Thyroid hormone receptor beta gene variant", - "Thyroid hormone receptor alpha gene variant", - "Thyroid hormone receptor beta gene abnormality", - "Thyroid hormone receptor alpha gene abnormality", - "Thyroid hormone receptor beta gene disorder", - "Thyroid hormone receptor alpha gene disorder", - "Thyroid hormone receptor beta gene dysfunction", - "Thyroid hormone receptor alpha gene dysfunction", - "Thyroid hormone receptor beta gene deficiency", - "Thyroid hormone receptor alpha gene deficiency", - "Thyroid hormone receptor beta gene excess", - "Thyroid hormone receptor alpha gene excess", - "Thyroid hormone receptor beta gene mutation syndrome", - "Thyroid hormone receptor alpha gene mutation syndrome", - "Thyroid hormone receptor beta gene defect syndrome", - "Thyroid hormone receptor alpha gene defect syndrome" - ] - }, - "human_summary": "25-year-old woman with fatigue, hair loss, weight gain, and cold intolerance for 6 months.", - "Clinician_B": [ - "Hashimoto's thyroiditis" - ], - "Clinician_C": [ - "Clinical Trial Fatigue Difficult Sleep hair loss voice change weight gain" - ], - "Clinician_A": [ - "First line treatment for hypothyrodisim", - "Genetic counselling for patients with Hashimoto's thyroiditis" - ], - "Clinician_D": [ - "hypothyroidism clinical trial", - "hashimoto's thyroiditis clinical trial", - "thyroxine clinical trial" - ] - }, - "sigir-201413": { - "raw": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", - "gpt-4-turbo": { - "summary": "A 30-year-old woman presents with shortness of breath, tachypnea, and tachycardia 3 weeks postpartum. She has a history of 2 natural abortions, but no other health problems. Her blood pressure is 110/70, oxygen saturation is 92%, and her chest x-ray and CBC are normal.", - "conditions": [ - "Postpartum period", - "Shortness of breath", - "Tachypnea", - "Tachycardia", - "History of natural abortions", - "Recent childbirth", - "Oxygen saturation decreased", - "Anxiety", - "Postpartum complications", - "Respiratory distress", - "Cardiac complications postpartum", - "Pulmonary embolism", - "Postpartum cardiomyopathy", - "Peripartum cardiomyopathy", - "Venous thromboembolism", - "Deep vein thrombosis", - "Heart failure", - "Arrhythmias", - "Hypoxia", - "Pulmonary hypertension", - "Anemia", - "Thyroid disorders", - "Preeclampsia", - "Eclampsia", - "Postpartum depression", - "Postpartum anxiety", - "Postpartum hemorrhage", - "Sepsis", - "Endometritis", - "Mastitis", - "Breastfeeding complications", - "Postpartum thyroiditis" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 30-year-old woman who presents with shortness of breath that started 2 hours before admission. She is generally healthy with no significant medical history besides 2 natural abortions. She recently gave birth to a healthy child 3 weeks ago. On examination, she is apprehensive, tachypneic, and tachycardic, with a blood pressure of 110/70 and oxygen saturation of 92%. Chest x-ray and CBC are normal.", - "conditions": [ - "Shortness of breath", - "Tachypnea", - "Tachycardia", - "Hypoxemia", - "Postpartum period", - "Pulmonary embolism", - "Anxiety", - "Respiratory distress", - "Pregnancy-related complications", - "Thromboembolism", - "Venous thromboembolism", - "Pulmonary hypertension", - "Pulmonary edema", - "Cardiac dysfunction", - "Hypertension", - "Hypotension", - "Hyperventilation", - "Hypoxia", - "Anemia", - "Infection", - "Pulmonary infection", - "Respiratory infection", - "Pulmonary embolism in pregnancy", - "Pulmonary embolism in postpartum period", - "Pulmonary embolism in women", - "Pulmonary embolism in young adults", - "Pulmonary embolism in otherwise healthy individuals", - "Pulmonary embolism in the absence of risk factors", - "Pulmonary embolism in the absence of deep vein thrombosis", - "Pulmonary embolism in the absence of cancer", - "Pulmonary embolism in the absence of surgery", - "Pulmonary embolism in the absence of trauma", - "Pulmonary embolism in the absence of immobilization" - ] - }, - "human_summary": "30-year-old woman who is 3 weeks post-partum, presents with shortness of breath, tachypnea, and hypoxia.", - "Clinician_B": [ - "Postpartum shortness of breath", - "postpartum VTEe" - ], - "Clinician_C": [ - "Clinical Trial Shortness of breath Low oxygen saturation" - ], - "Clinician_A": [ - "post-pregnancy shock in new mothers" - ], - "Clinician_D": [ - "postpartum VTE", - "postpartum embolus", - "postpartum pulmonary embolus" - ] - }, - "sigir-201414": { - "raw": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", - "gpt-4-turbo": { - "summary": "An 85-year-old man presents with a gradual decrease in consciousness, cessation of walking and eating by himself, with no fever, cough, rash, or diarrhea. This follows a car accident 3 weeks prior, after which a head CT was normal.", - "conditions": [ - "Decreased level of consciousness", - "Acute encephalopathy", - "Post-traumatic sequelae", - "Cerebral contusion", - "Traumatic brain injury", - "Subdural hematoma", - "Elderly", - "Nutritional deficiency", - "Dehydration", - "Sedentary lifestyle complications", - "Cognitive decline", - "Dementia", - "Stroke", - "Brain neoplasms", - "Intracranial hemorrhage", - "Subarachnoid hemorrhage", - "Electrolyte imbalance", - "Hypoglycemia", - "Hypoxia", - "Sepsis", - "Urinary tract infection", - "Pneumonia", - "Chronic kidney disease", - "Liver disease", - "Heart failure", - "Atrial fibrillation", - "Venous thromboembolism", - "Peripheral artery disease", - "Depression", - "Anxiety", - "Sleep disorders", - "Substance abuse" - ] - }, - "gpt-35-turbo": { - "summary": "An 85-year-old man with gradual decrease in level of consciousness, inability to walk and eat independently, and history of car accident", - "conditions": [ - "Decreased level of consciousness", - "Inability to walk", - "Inability to eat independently", - "Car accident", - "Head injury", - "Altered mental status", - "Cognitive decline", - "Neurological symptoms", - "Traumatic brain injury", - "Subdural hematoma", - "Brain hemorrhage", - "Brain contusion", - "Brain edema", - "Brain swelling", - "Concussion", - "Brain trauma", - "Brain damage", - "Brain dysfunction", - "Brain impairment", - "Brain disorder", - "Brain pathology", - "Brain abnormality", - "Brain lesion", - "Brain mass", - "Brain tumor", - "Brain metastasis", - "Brain infection", - "Brain inflammation", - "Brain abscess", - "Brain cyst", - "Brain malformation", - "Brain degeneration", - "Brain atrophy" - ] - }, - "human_summary": "85-year-old man who was in a car accident 3 weeks ago, now with 3 days of progressively decreasing level of consciousness and impaired ability to perform activities of daily living.", - "Clinician_B": [ - "Subdural haemorrhage", - "Elderly trauma" - ], - "Clinician_C": [ - "Clinical Trial Elderly Decreased cognition decreased functioning" - ], - "Clinician_A": [ - "Post traumatic imaging in the elderly", - "Follow up post trauma for elderly patients suspected of having subdural haematomas" - ], - "Clinician_D": [ - "delirium clinical trial", - "delirium in elderly patient clinical trial", - "hypoactive delirium" - ] - }, - "sigir-201415": { - "raw": "A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.", - "gpt-4-turbo": { - "summary": "A 36-year-old woman with 12 weeks of amenorrhea, vaginal spotting, lower abdominal tenderness, nausea, vomiting, an 18-week sized uterus, cervical dilation of 2 cm, and a negative pregnancy test. Ultrasound shows an enlarged uterus with multiple cystic areas. Differential diagnosis includes vesicular mole vs fibroid degeneration.", - "conditions": [ - "Vesicular mole", - "Fibroid degeneration", - "Amenorrhea", - "Vaginal spotting", - "Lower abdominal tenderness", - "Nausea", - "Vomiting", - "Cervical dilation", - "Negative pregnancy test", - "Enlarged uterus", - "Cystic areas in uterus", - "Uterine fibroids", - "Gestational trophoblastic disease", - "Abdominal pain", - "Uterine abnormalities", - "Molar pregnancy", - "Hydatidiform mole", - "Uterine bleeding", - "Pelvic pain", - "Gynecological ultrasound", - "HCG negative pregnancy", - "Abnormal uterine bleeding", - "Miscarriage", - "Early pregnancy complications", - "Gynecologic oncology", - "Reproductive endocrinology", - "Pelvic inflammatory disease", - "Endometriosis", - "Polycystic ovary syndrome", - "Infertility", - "Emergency gynecology", - "Gynecological emergency" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 36-year-old woman presenting with 12 weeks of amenorrhea, vaginal spotting, lower abdominal tenderness, nausea, and vomiting. Physical exam reveals an overall tender abdomen, an 18-week sized uterus, and cervical dilation of 2 cm. The ultrasound reports an enlarged uterus with multiple cystic areas in the interior. The main differential diagnosis includes vesicular mole vs fibroid degeneration.", - "conditions": [ - "Amenorrhea", - "Vaginal spotting", - "Lower abdominal tenderness", - "Nausea", - "Vomiting", - "Tender abdomen", - "Enlarged uterus", - "Cervical dilation", - "Cystic areas in uterus", - "Vesicular mole", - "Fibroid degeneration", - "Uterine fibroids", - "Gestational trophoblastic disease", - "Molar pregnancy", - "Uterine cysts", - "Uterine abnormalities", - "Uterine neoplasms", - "Uterine tumors", - "Uterine growths", - "Uterine masses", - "Uterine enlargement", - "Uterine bleeding", - "Abnormal uterine bleeding", - "Pelvic pain", - "Abdominal pain", - "Gynecological disorders", - "Reproductive system diseases", - "Pregnancy complications", - "Gynecologic neoplasms", - "Gynecologic abnormalities", - "Gynecologic tumors", - "Gynecologic masses", - "Gynecologic bleeding" - ] - }, - "human_summary": "36-year-old woman with amenorrhea, abdominal tenderness, enlarged uterus, and cervical dilation. Urine pregnancy test is negative. Ultrasound reveals an enlarged uterus with multiple cystic areas, which could be consistent with vesicular mole and fibroid degeneration.", - "Clinician_B": [ - "vesicular mole", - "uterine fibroids" - ], - "Clinician_C": [ - "Clinical Trial Amenorrhea spotting cysts Nausea vomiting vesicular mole", - "Clinical Trial Amenorrhea spotting cysts Nausea vomiting fibroid" - ], - "Clinician_A": [ - "Beneftis of D&C of vesicular moles", - "Side effects of total hysterectomy due to mole growth or degeneratin of fibroids" - ], - "Clinician_D": [ - "molar pregnancy clinical trial", - "vesicular mole trial", - "hydatidiform mole trial", - "uterine fibroid degeneration trial", - "fibroid degeneration trial" - ] - }, - "sigir-201416": { - "raw": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", - "gpt-4-turbo": { - "summary": "A 28-year-old female experiencing neck and shoulder pain, left hand and arm paresthesias, slight tremors, almost imperceptible spasticity, spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficulty swallowing, and marked hydrophobia three weeks after attending a stray animal recovery campaign in California. Initially prescribed NSAIDs and a topical muscle relaxant, her condition worsened, leading to hospitalization.", - "conditions": [ - "Rabies", - "Paresthesia", - "Neck pain", - "Shoulder pain", - "Tremors", - "Spasticity", - "Sweating", - "Agitation", - "Anxiety", - "Malaise", - "Dysphagia", - "Hydrophobia", - "Spastic movements", - "Muscle relaxant use", - "NSAID use", - "Animal bite exposure", - "Infectious diseases", - "Neurological disorders", - "Pain management", - "Emergency care", - "Psychological distress", - "Involuntary movements", - "Muscle stiffness", - "Fever", - "Infection control", - "Public health", - "Travel-related health issues", - "Vaccination", - "Antiviral drugs", - "Immunoglobulin therapy", - "Critical care", - "Supportive care" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 28-year-old female who presented with neck and shoulder pain, left hand and arm paresthesias, tremors, spasticity, spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficulty swallowing, marked hydrophobia, and was immediately hospitalized.", - "conditions": [ - "Neck pain", - "Shoulder pain", - "Paresthesias", - "Tremors", - "Spasticity", - "Spastic arm movements", - "Sweating", - "Increasing agitation", - "Anxiety", - "Malaise", - "Difficulty swallowing", - "Hydrophobia" - ] - }, - "human_summary": "28-year-old female with neck pain and left arm numbness 3 weeks after working with stray animals. Physical exam initially remarkable for slight left arm tremor and spasticity. Three days later she presented with significant arm spasticity, diaphoresis, agitation, difficulty swallowing, and hydrophobia.", - "Clinician_B": [ - "rabies" - ], - "Clinician_C": [ - "Clinical Trial Parathesis arm stray animal tremors", - "Clinical Trial increasing paralysis swallowing, malaise spastic arm movements" - ], - "Clinician_A": [ - "Rabies vaccination for travellers and workers in endemic countries", - "First line treatment for rabies virus", - "Prognostic factors for unindentified rabies virus" - ], - "Clinician_D": [ - "rabies trial" - ] - }, - "sigir-201417": { - "raw": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", - "gpt-4-turbo": { - "summary": "A 48-year-old male with common variable immunodeficiency (CVID) presented with acute abdominal pain, fever, dehydration, tachycardia, hypotension, and signs of a ruptured liver abscess, which was surgically drained and required ICU care.", - "conditions": [ - "Common Variable Immunodeficiency", - "Ruptured liver abscess", - "Acute abdominal pain", - "Fever", - "Dehydration", - "Tachycardia", - "Hypotension", - "Hepatomegaly", - "Intraperitoneal fluid", - "Surgical drainage complications", - "Intensive care unit care", - "Infectious complications in immunodeficiency", - "Liver abscess", - "Abdominal infection", - "Sepsis", - "Shock", - "Immunodeficiency disorders", - "Autoimmune disorders", - "Infection control in immunocompromised patients", - "Postoperative care", - "Antibiotic therapy", - "Fluid resuscitation", - "Critical care", - "Invasive procedures in immunocompromised patients", - "Pain management", - "Nutritional support in critical illness", - "Monitoring and management of tachycardia", - "Blood pressure management", - "Liver diseases", - "Abdominal surgery", - "Emergency surgery", - "Peritonitis" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 48-year-old white male with a history of common variable immunodeficiency (CVID) presenting with acute abdominal pain, fever, dehydration, tachycardia, and hypotension. Physical examination reveals tenderness and a positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is surgically drained. The patient is subsequently admitted to the ICU.", - "conditions": [ - "Common variable immunodeficiency (CVID)", - "Acute abdominal pain", - "Fever", - "Dehydration", - "Tachycardia", - "Hypotension", - "Tenderness", - "Positive Murphy sign", - "Hepatomegaly", - "Intraperitoneal fluid", - "Ruptured liver abscess", - "Surgical drainage", - "ICU admission" - ] - }, - "human_summary": "48-year-old man with common variable immunodeficiency presents with abdominal pain and fever. Ultrasound reveals hepatomegaly and free intraperitoneal fluid. A ruptured liver abscess is found and drained during exploratory laparotomy.", - "Clinician_B": [ - "ruptured liver abscess", - "CVID" - ], - "Clinician_C": [ - "Clinical Trial CVID abdo pain fever Tenderness enlarged liver" - ], - "Clinician_A": [ - "Prognostic factors after abundant free fluid in the peritoneum", - "Hydatid cyst in the liver" - ], - "Clinician_D": [ - "liver abcscess in CVID trial" - ] - }, - "sigir-201418": { - "raw": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", - "gpt-4-turbo": { - "summary": "A 6-month-old male infant is experiencing acute kidney injury (AKI) characterized by oliguria (urine output of less than 0.2 mL/kg/hr) following major surgery, generalized edema, elevated blood pressure, tachycardia, and abnormal laboratory findings including elevated blood urea nitrogen and serum creatinine levels, as well as abnormal urinalysis results indicating renal impairment.", - "conditions": [ - "Acute kidney injury", - "Oliguria", - "Pediatric surgery complications", - "Generalized edema", - "Hypertension in infants", - "Tachycardia in infants", - "Elevated blood urea nitrogen", - "Elevated serum creatinine", - "Abnormal urinalysis", - "Renal impairment", - "Postoperative complications", - "Fluid and electrolyte imbalances", - "Renal function tests", - "Acute renal failure", - "Renal tubular dysfunction", - "Intravenous fluid therapy", - "Renal ultrasound", - "Kidney diseases in children", - "Nephrology", - "Pediatric nephrology", - "Renal biopsy", - "Renal replacement therapy", - "Dialysis in infants", - "Acute tubular necrosis", - "Renal vascular disorders", - "Electrolyte management", - "Blood pressure management", - "Critical care nephrology", - "Pediatric intensive care", - "Renal protective strategies", - "Fluid management in infants", - "Renal recovery" - ] - }, - "gpt-35-turbo": { - "summary": "The main medical problems of the patient are decreased urine output, generalized edema, and abnormal urinalysis findings.", - "conditions": [ - "Decreased urine output", - "Generalized edema", - "Abnormal urinalysis", - "Postoperative complications", - "Renal dysfunction", - "Acute kidney injury", - "Fluid overload", - "Hypovolemia", - "Renal tubular dysfunction", - "Glomerular injury", - "Renal ischemia", - "Renal inflammation", - "Renal tubular necrosis", - "Renal vasoconstriction", - "Renal hypoperfusion", - "Renal parenchymal damage", - "Renal impairment", - "Renal insufficiency", - "Renal failure", - "Nephrotoxicity", - "Renal artery stenosis", - "Renal artery thrombosis", - "Renal vein thrombosis", - "Renal cysts", - "Renal calculi", - "Renal cell carcinoma", - "Renal hypertension", - "Renal dysplasia", - "Renal agenesis", - "Renal tubular acidosis", - "Renal osteodystrophy", - "Renal transplantation", - "Renal biopsy" - ] - }, - "human_summary": "6-month-old male with decreased urine output and edema several hours after surgery. He is hypertensive and tachycardic, has a high BUN and creatinine, and urine microscopy reveals red blood cells and granular casts.", - "Clinician_B": [ - "Nephritic syndrome infant", - "postoperative haematuria infant", - "postoperative reduced urine output infant" - ], - "Clinician_C": [ - "Clinical Trial infant low urine output" - ], - "Clinician_A": [ - "oliguric renal failure post surgery in an infant" - ], - "Clinician_D": [ - "post op acute kidney injury", - "acute kidney injury after pediatric surgery", - "acute kidney injury in infants" - ] - }, - "sigir-201419": { - "raw": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", - "gpt-4-turbo": { - "summary": "A 52-year-old African American man with a history of heavy smoking and drinking presents with progressive dysphagia, initially with solids and progressing to liquids, weight loss of 25 pounds, and sensation of food obstruction at the lower end of his sternum.", - "conditions": [ - "Esophageal cancer", - "Dysphagia", - "Esophageal obstruction", - "Weight loss", - "Smoking", - "Alcohol use disorder", - "Esophageal stricture", - "Esophageal adenocarcinoma", - "Esophageal squamous cell carcinoma", - "Barrett's esophagus", - "Gastroesophageal reflux disease (GERD)", - "Esophagitis", - "Achalasia", - "Esophageal motility disorders", - "Nutritional deficiency", - "Esophageal ulcer", - "Esophageal varices", - "Esophageal perforation", - "Esophageal diverticula", - "Plummer-Vinson syndrome", - "Esophageal web", - "Esophageal ring", - "Zenker's diverticulum", - "Esophageal leiomyoma", - "Esophageal candidiasis", - "Esophageal tuberculosis", - "Esophageal lymphoma", - "Esophageal foreign body", - "Esophageal trauma", - "Radiation esophagitis", - "Chemotherapy-induced esophagitis", - "Esophageal sarcoidosis" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 52-year-old African American man with a history of heavy smoking and drinking. He presents with progressive dysphagia, starting with difficulty swallowing meat and progressing to include other solid foods, soft foods, and liquids. He has lost 25 pounds and can locate the point of obstruction at the lower end of his sternum.", - "conditions": [ - "Dysphagia", - "Obstruction of the esophagus", - "Weight loss", - "Heavy smoking", - "Heavy drinking", - "Esophageal cancer", - "Esophageal stricture", - "Esophageal motility disorders", - "Gastroesophageal reflux disease (GERD)", - "Barrett's esophagus", - "Achalasia", - "Esophageal diverticulum", - "Esophageal spasm", - "Esophageal ulcer", - "Esophageal varices", - "Esophageal perforation", - "Esophageal candidiasis", - "Esophageal foreign body", - "Esophageal dysmotility", - "Esophageal stenosis", - "Esophageal web", - "Esophageal ring", - "Esophageal stricture", - "Esophageal tumor", - "Esophageal obstruction", - "Esophageal inflammation", - "Esophageal infection", - "Esophageal injury", - "Esophageal pain", - "Esophageal reflux", - "Esophageal sphincter dysfunction", - "Esophageal swelling", - "Esophageal narrowing" - ] - }, - "human_summary": "52-year-old man with history of smoking and heavy drinking, now with progressive dysphagia and 25-pound weight loss.", - "Clinician_B": [ - "smoking malignancy", - "smoking throat cancer", - "alcoholism throat cancer", - "progressive dysphagia" - ], - "Clinician_C": [ - "Clinical Trial Dysphagia Smoker difficulty smoking weight loss", - "Clinical Trial Dysphagia Smoker difficulty smoking weight loss cancer" - ], - "Clinician_A": [ - "adenocarcinoma of the throat", - "first line treatment of oesophageal adenocarcinomas" - ], - "Clinician_D": [ - "esophageal cancer trial", - "esophageal cancer radiotherapy trial", - "esophageal cancer chemotherapy trial" - ] - }, - "sigir-20142": { - "raw": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", - "gpt-4-turbo": { - "summary": "An 8-year-old male with fever, dyspnea, cough, recent travel history to Colorado, loose stools prior to respiratory symptoms, respiratory distress, bronchial respiratory sounds on the left, and bilateral lung infiltrates on chest x-ray.", - "conditions": [ - "Pneumonia", - "Pediatric pneumonia", - "Respiratory distress", - "Fever in children", - "Cough in children", - "Travel-related illness", - "Bilateral lung infiltrates", - "Bronchial breathing", - "Dyspnea in children", - "Infectious diseases", - "Viral pneumonia", - "Bacterial pneumonia", - "Gastrointestinal symptoms in children", - "Loose stools in children", - "Acute respiratory distress syndrome (ARDS)", - "Lower respiratory tract infection", - "Community-acquired pneumonia", - "Pediatric infectious diseases", - "Pediatric emergency medicine", - "Respiratory infections", - "Respiratory syncytial virus (RSV)", - "Influenza", - "Mycoplasma pneumoniae", - "Legionnaires' disease", - "Hypoxia in children", - "Pneumocystis pneumonia (PCP)", - "Tuberculosis (TB)", - "Histoplasmosis", - "Cryptogenic organizing pneumonia", - "SARS-CoV-2 (COVID-19)", - "Aspiration pneumonia", - "Environmental lung diseases" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is an 8-year-old male who presents with fever, dyspnea, and cough after returning from a vacation in Colorado. He also had loose stools prior to the onset of symptoms. On examination, he is in respiratory distress and has bilateral lung infiltrates on chest x-ray.", - "conditions": [ - "Fever", - "Dyspnea", - "Cough", - "Loose stools", - "Respiratory distress", - "Bronchial respiratory sounds", - "Bilateral lung infiltrates", - "Pneumonia", - "Respiratory infection", - "Travel-related illness", - "Colorado", - "Influenza", - "Viral infection", - "Bacterial infection", - "Respiratory syncytial virus (RSV)", - "Bronchitis", - "Asthma exacerbation", - "Pulmonary edema", - "Pulmonary embolism", - "Acute respiratory distress syndrome (ARDS)", - "Pneumocystis pneumonia", - "Tuberculosis", - "Pertussis", - "Measles", - "Mycoplasma pneumonia", - "Legionnaires' disease", - "Hantavirus pulmonary syndrome", - "Histoplasmosis", - "Coccidioidomycosis", - "Q fever", - "Psittacosis", - "Chlamydia pneumoniae infection", - "Adenovirus infection" - ] - }, - "human_summary": "8-year-old boy with 2 days of loose stools, fever, and cough after returning from a trip to Colorado. Chest x-ray shows bilateral lung infiltrates.", - "Clinician_A": [ - "First line treatment of Colorado Tick Fever in children", - "Analgesic and Antipyretic options for treatment of Colorado Tick Fever in children" - ], - "Clinician_B": [ - "Colorado infectious disease", - "Travel fever trial", - "Travel diarrhoea trial", - "Travel gastroenteritis" - ], - "Clinician_D": [ - "pnuemonia antibiotic trial" - ], - "Clinician_C": [ - "Clinical Trial Fever Cough Short of Breathe Children" - ] - }, - "sigir-201420": { - "raw": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", - "gpt-4-turbo": { - "summary": "A 32-year-old woman admitted to the ER after a car accident with multiple upper and lower extremity fractures, tender abdomen with guarding and rebound, and absence of bowel sounds, indicating potential internal injuries.", - "conditions": [ - "Multiple fractures", - "Car accident injuries", - "Abdominal trauma", - "Blunt abdominal trauma", - "Internal injuries", - "Absence of bowel sounds", - "Guarding and rebound tenderness", - "Upper extremity fractures", - "Lower extremity fractures", - "Non-use of seat belt", - "Traumatic injuries", - "Emergency care", - "Acute pain", - "Shock", - "Hemorrhage", - "Injury of abdomen", - "Injury of upper extremity", - "Injury of lower extremity", - "Fracture healing", - "Orthopedic injuries", - "Physical trauma", - "Abdominal guarding", - "Abdominal pain", - "Trauma surgery", - "Critical care", - "Traumatic shock", - "Post-traumatic stress disorder", - "Pain management", - "Rehabilitation", - "Surgical intervention", - "Emergency surgery", - "Traumatic injury recovery" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 32-year-old woman who was admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", - "conditions": [ - "Abdominal trauma", - "Fractures", - "Seat belt non-use", - "Tender abdomen", - "Guarding", - "Rebound tenderness", - "Bowel sounds absence", - "Upper extremity fractures", - "Lower extremity fractures", - "Car accident", - "Hypertension", - "Tachycardia", - "Abdominal pain", - "Abdominal guarding", - "Abdominal rebound tenderness", - "Bowel obstruction", - "Abdominal trauma evaluation", - "Orthopedic trauma", - "Traumatic injuries", - "Emergency room admission", - "Seat belt injury", - "Abdominal examination", - "Abdominal injuries", - "Abdominal trauma management", - "Fracture management", - "Extremity fractures evaluation", - "Car accident injuries", - "Hypertension evaluation", - "Tachycardia evaluation", - "Abdominal pain evaluation", - "Orthopedic trauma management", - "Traumatic injuries evaluation" - ] - }, - "human_summary": "32-year-old unbelted driver status post car accident. Has multiple extremity fractures and severe abdominal pain with rebound and guarding.", - "Clinician_B": [ - "car accident", - "motor vehicle accident", - "multiple traumatic fractures", - "tender abdomen car accident", - "tender abdomen absent bowel sounds" - ], - "Clinician_C": [ - "Clinical Trial Post Car accident tender abdomen without seatbelt" - ], - "Clinician_A": [ - "Incidence of Internal haemorrhage post-vehicular collisions.", - "Benefits of wearing a seat belt in MVA" - ], - "Clinician_D": [ - "traumatic acute abdomen trial", - "ischemic abdomen post trauma trial" - ] - }, - "sigir-201421": { - "raw": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", - "gpt-4-turbo": { - "summary": "A 21-year-old female presents with progressive arthralgias, malaise, alopecia, a facial rash, non-palpable purpura on her calves, swelling and tenderness of her wrists and ankles, normocytic anemia, thrombocytopenia, positive ANA and anti-dsDNA, and urine positive for protein and RBC casts.", - "conditions": [ - "Systemic Lupus Erythematosus", - "Arthralgia", - "Malaise", - "Alopecia", - "Malar Rash", - "Purpura", - "Joint Swelling", - "Joint Tenderness", - "Normocytic Anemia", - "Thrombocytopenia", - "Antinuclear Antibody Positive", - "Anti-dsDNA Positive", - "Proteinuria", - "Hematuria", - "Autoimmune Diseases", - "Connective Tissue Diseases", - "Rheumatologic Disorders", - "Kidney Diseases", - "Glomerulonephritis", - "Lupus Nephritis", - "Chronic Fatigue Syndrome", - "Skin Manifestations", - "Blood Disorders", - "Immune System Diseases", - "Inflammatory Disorders", - "Musculoskeletal Pain", - "Renal Insufficiency", - "Chronic Kidney Disease" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 21-year-old female presenting with progressive arthralgias, malaise, alopecia, rash on the bridge of her nose and cheeks, non-palpable purpura on her calves, swelling and tenderness of wrists and ankles, normocytic anemia, thrombocytopenia, positive ANA and anti-dsDNA, and positive protein and RBC casts in urine.", - "conditions": [ - "Systemic lupus erythematosus", - "Lupus nephritis", - "Arthralgias", - "Malaise", - "Alopecia", - "Rash", - "Purpura", - "Swelling", - "Tenderness", - "Normocytic anemia", - "Thrombocytopenia", - "Positive ANA", - "Positive anti-dsDNA", - "Proteinuria", - "RBC casts", - "Autoimmune disease", - "Connective tissue disease", - "Kidney involvement", - "Joint pain", - "Fatigue", - "Hair loss", - "Skin rash", - "Blood disorder", - "Immunologic disorder", - "Renal disorder", - "Inflammatory disorder", - "Autoantibodies", - "Glomerulonephritis", - "Vasculitis", - "Systemic disease", - "Immune system dysfunction", - "Kidney damage", - "Joint inflammation" - ] - }, - "human_summary": "21-year-old female with progressive arthralgias, fatigue, and butterfly-shaped facial rash. Labs are significant for positive ANA and anti-double-stranded DNA, as well as proteinuria and RBC casts.", - "Clinician_B": [ - "lupus", - "SLE" - ], - "Clinician_C": [ - "Clinical Trial arthritis fatigue loss of hair face rash swelling", - "Clinical Trial arthritis fatigue loss of hair face rash swelling Female" - ], - "Clinician_A": [ - "First line treatment for SLE", - "Life long side effects of ftreatment for SLE" - ], - "Clinician_D": [ - "SLE clinical trial", - "systemic lupus erythematosus trial", - "SLE hydroxychloroquine trial", - "SLE corticosteroids trial", - "SLE NSAIDs trial" - ] - }, - "sigir-201422": { - "raw": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", - "gpt-4-turbo": { - "summary": "A 15-year-old girl presents with gradual abdominal pain, initially periumbilical then localizing to the right lower quadrant, with no appetite, no diarrhea, regular menses, and no sexual partners. Examination reveals localized rebound tenderness in the right lower quadrant and an abdominal ultrasound shows a markedly edematous appendix.", - "conditions": [ - "Acute appendicitis", - "Appendiceal edema", - "Right lower quadrant pain", - "Abdominal pain in adolescents", - "Loss of appetite", - "Rebound tenderness", - "Pediatric emergency medicine", - "Non-sexually active female adolescent", - "Regular menses", - "Abdominal ultrasound findings in appendicitis", - "Periumbilical pain", - "Localized abdominal pain", - "Appendicitis without diarrhea", - "Pediatric surgery", - "Pediatric gastroenterology", - "Abdominal pain", - "Pediatric appendicitis", - "Emergency surgery", - "Appendectomy", - "Minimally invasive surgical techniques for appendicitis", - "Postoperative care in pediatric surgery", - "Pain management in pediatric patients", - "Diagnostic imaging in appendicitis", - "Pediatric radiology", - "Non-operative management of appendicitis", - "Antibiotic therapy for appendicitis", - "Complications of appendicitis", - "Follow-up care after appendicitis", - "Healthcare in adolescents", - "Surgical outcomes in pediatric appendicitis", - "Inflammatory markers in appendicitis", - "Pediatric pain assessment" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 15-year-old girl presenting with abdominal pain and localized rebound tenderness over the right lower quadrant. An abdominal ultrasound reveals a markedly edematous appendix.", - "conditions": [ - "Appendicitis", - "Abdominal pain", - "Rebound tenderness", - "Right lower quadrant pain", - "Edematous appendix", - "Periumbilical pain", - "Loss of appetite", - "Regular menses", - "Abdominal ultrasound" - ] - }, - "human_summary": "15-year-old girl with right lower quadrant abdominal pain, decreased appetite, and enlarged appendix on abdominal ultrasound.", - "Clinician_B": [ - "appendicitis", - "appendicitis adolescent" - ], - "Clinician_A": [ - "Appendicitis medical imaging - What's good?", - "Appendicitis vs mesentric adenitis" - ], - "Clinician_D": [ - "appendicitis trial", - "appendicectomy trial" - ] - }, - "sigir-201423": { - "raw": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", - "gpt-4-turbo": { - "summary": "A 63-year-old man with a history of heavy smoking, spinal stenosis, diabetes, hypothyroidism, and mild psoriasis presents with cough, shortness of breath, productive cough with purulent sputum, and difficulty breathing. He has been using home oxygen for the past 24 hours. Examination reveals cyanosis, tachypnea, a barrel-shaped chest, and diffuse rales over his lungs. Chest x-ray shows hyperinflation without consolidation. He also has a family history of early onset dementia.", - "conditions": [ - "Chronic obstructive pulmonary disease (COPD)", - "Bronchitis", - "Emphysema", - "Smoking", - "Spinal stenosis", - "Diabetes", - "Hypothyroidism", - "Psoriasis", - "Dementia", - "Respiratory infection", - "Chronic respiratory failure", - "Oxygen therapy", - "Cyanosis", - "Tachypnea", - "Hyperinflation of lungs", - "Shortness of breath", - "Cough", - "Purulent sputum", - "Family history of dementia", - "Barrel chest", - "Diffuse rales", - "Home oxygen use", - "Productive cough", - "Difficulty breathing", - "No fever", - "Lung hyperinflation", - "Early onset dementia", - "Heavy smoking history", - "Respiratory distress", - "Chronic cough", - "Breathlessness", - "Airway obstruction" - ] - }, - "gpt-35-turbo": { - "summary": "A 63-year-old man with cough, shortness of breath, heavy smoking history, spinal stenosis, diabetes, hypothyroidism, mild psoriasis, and family history of early onset dementia.", - "conditions": [ - "Chronic obstructive pulmonary disease", - "Emphysema", - "COPD exacerbation", - "Respiratory infection", - "Bronchitis", - "Pneumonia", - "Lung inflammation", - "Lung infection", - "Cyanosis", - "Tachypnea", - "Barrel chest", - "Rales", - "Hyperinflation", - "Productive cough", - "Purulent sputum", - "Difficulty breathing", - "Home oxygen use", - "Smoking-related lung disease", - "Spinal stenosis", - "Diabetes", - "Hypothyroidism", - "Psoriasis", - "Family history of early onset dementia", - "Chest X-ray abnormalities", - "Lung function impairment", - "Respiratory distress", - "Chronic respiratory symptoms", - "Lung disease exacerbation", - "Inflammatory lung condition", - "Respiratory failure", - "Lung function decline", - "Airway obstruction", - "Chronic lung disease" - ] - }, - "human_summary": "63-year-old heavy smoker with productive cough, shortness of breath, tachypnea, and oxygen requirement. Chest x-ray shows hyperinflation with no consolidation.", - "Clinician_B": [ - "acute exacerbation of COPD", - "COPD smoking" - ], - "Clinician_C": [ - "Clinical Trial Cough Smoker Diabetes X-ray hyperinflation" - ], - "Clinician_A": [ - "Viral infective exacerbation of COPD", - "Treating multiple diseases at once in the setting of an infective exacerbation" - ], - "Clinician_D": [ - "COPD exacerbation trial", - "COPD infective exacerbation trial", - "COPD antibiotics trial", - "COPD corticosteroids trial" - ] - }, - "sigir-201424": { - "raw": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", - "gpt-4-turbo": { - "summary": "A 33-year-old male athlete with acute abdominal pain due to spleen rupture following a blunt trauma from a bike fall. The patient has extended intraperitoneal hemorrhage, hypotension (BP: 60/30 mmHg), and tachycardia (HR: 140/min).", - "conditions": [ - "Spleen rupture", - "Intraperitoneal hemorrhage", - "Blunt abdominal trauma", - "Acute abdominal pain", - "Hypotension", - "Tachycardia", - "Non-smoker", - "Non-drug user", - "Non-alcoholic", - "Traumatic injury", - "Emergency care", - "Abdominal trauma", - "Athlete health", - "Physical trauma", - "Abdominal pain", - "Muscle contraction", - "Muscle resistance", - "Hemodynamic instability", - "Critical care", - "Emergency ultrasound", - "CT scan abdomen", - "Trauma surgery", - "Splenectomy", - "Blood transfusion", - "Hemorrhagic shock", - "Traumatic splenic injury", - "Abdominal surgery", - "Post-traumatic recovery", - "Pain management", - "Injury prevention", - "Athletic injuries", - "Fall injuries" - ] - }, - "gpt-35-turbo": { - "summary": "The main medical problems of the patient include acute abdominal pain, blunt trauma to the left hemi-abdomen, extended intraperitoneal hemorrhage, and spleen rupture.", - "conditions": [ - "Acute abdominal pain", - "Blunt trauma", - "Left hemi-abdomen", - "Intraperitoneal hemorrhage", - "Spleen rupture", - "Hypotension", - "Tachycardia", - "Pale appearance", - "Muscle contraction", - "Abdominal resistance", - "Emergency ultrasound", - "CT scan", - "Hemorrhage", - "Spleen injury", - "Abdominal trauma", - "Abdominal injuries", - "Abdominal bleeding", - "Abdominal trauma management", - "Spleen trauma", - "Spleen injuries", - "Intraperitoneal bleeding", - "Intraperitoneal hemorrhage management", - "Hypovolemic shock", - "Traumatic shock", - "Abdominal pain management", - "Emergency medicine", - "Trauma surgery", - "Surgical intervention", - "Blood transfusion", - "Hemostasis", - "Splenectomy", - "Spleen-preserving surgery", - "Recovery after spleen injury" - ] - }, - "human_summary": "33-year-old male presents with severe abdominal pain one week after a bike accident in which he sustained abdominal trauma. He is hypotensive and tachycardic, and imaging reveals a ruptured spleen and intraperitoneal hemorrhage.", - "Clinician_B": [ - "acute abdomen delayed diagnosis", - "blunt trauma delayed diagnosis", - "intraperitoneal haemorrhage" - ], - "Clinician_C": [ - "Clinical Trial Abdo Pain left side nonsmoker", - "Clinical Trial 7 day Post injury Spleen Rupture Abdo Pain" - ], - "Clinician_A": [ - "Prognostic factors associated with prolonged exposure to internal haemorrhage", - "Ongoing medical treatment required post splenectomy" - ], - "Clinician_D": [ - "splenic injury trial", - "ruptured spleen trial", - "traumatic spleen rupture trial", - "splenic rupture surgery trial" - ] - }, - "sigir-201425": { - "raw": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", - "gpt-4-turbo": { - "summary": "An 8-year-old boy experienced a fall from his bike, striking his left temple on the pavement. Initially, he showed no signs of severe injury but later became drowsy, pale, and vomited. Upon emergency department arrival, he presented with a low heart rate, high blood pressure, a low Glasgow Coma Scale score, asymmetrical pupils, and impaired movement in the right extremities, indicating a serious head injury.", - "conditions": [ - "Head injury", - "Traumatic brain injury", - "Concussion", - "Intracranial hemorrhage", - "Pediatric trauma", - "Skull fracture", - "Cerebral contusion", - "Brain edema", - "Increased intracranial pressure", - "Vomiting", - "Bradycardia", - "Hypertension", - "Neurological trauma", - "Loss of consciousness", - "Pupil asymmetry", - "Motor impairment", - "Emergency care", - "Post-traumatic symptoms", - "Drowsiness", - "Pallor", - "Glasgow Coma Scale", - "Pediatric emergency medicine", - "Head trauma", - "Cerebral concussion", - "Subdural hematoma", - "Epidural hematoma", - "Cerebral hemorrhage", - "Brain injury", - "Neurosurgery", - "Pediatric neurosurgery", - "Pediatric neurology", - "Trauma surgery" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is an 8-year-old boy who fell from his bike and experienced symptoms such as drowsiness, pale skin, vomiting, asymmetrical pupils, impaired movement in the right extremities, and a decreased Glasgow Coma Scale (GCS) score. The neurosurgical team recommended immediate treatment instead of a CT scan.", - "conditions": [ - "Head injury", - "Traumatic brain injury", - "Intracranial hemorrhage", - "Concussion", - "Cerebral contusion", - "Skull fracture", - "Epidural hematoma", - "Subdural hematoma", - "Intracerebral hemorrhage", - "Brain swelling", - "Cerebral edema", - "Increased intracranial pressure", - "Neurological impairment", - "Altered mental status", - "Impaired consciousness", - "Vomiting", - "Drowsiness", - "Pale skin", - "Asymmetrical pupils", - "Impaired movement", - "Decreased Glasgow Coma Scale (GCS) score", - "Emergency department", - "Neurosurgical treatment", - "CT scan", - "Immediate treatment", - "Pediatric head injury", - "Pediatric traumatic brain injury", - "Pediatric intracranial hemorrhage", - "Pediatric concussion", - "Pediatric cerebral contusion", - "Pediatric skull fracture", - "Pediatric epidural hematoma", - "Pediatric subdural hematoma" - ] - }, - "human_summary": "8-year-old boy with decreased level of consciousness 30 minutes after falling from his bike and hitting his head. He was not wearing a helmet. In the ER he was bradycardic and hypertensive, and the neurosurgeon strongly advised immediate treatment.", - "Clinician_B": [ - "paediatric head injury", - "paediatric head trauma" - ], - "Clinician_A": [ - "TBI in children" - ], - "Clinician_C": [ - "Clinical Trial Injury to head drowsy vomitting asymettrical pupils" - ], - "Clinician_D": [ - "subdural hematoma trial", - "subdural hematoma surgery trial", - "subdural hemorrhage trial" - ] - }, - "sigir-201427": { - "raw": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", - "gpt-4-turbo": { - "summary": "A 21-year-old college student with a family history of multiple colonic polyps and siblings who underwent total proctocolectomies due to hundreds of colonic adenomas. The patient has dozens of small colonic polyps within the rectosigmoid, all biopsied and found to be benign adenomas.", - "conditions": [ - "Familial adenomatous polyposis", - "Colonic polyps", - "Adenomatous polyps", - "Rectosigmoid polyps", - "Genetic predisposition to cancer", - "Colonoscopy", - "Sigmoidoscopy", - "Benign colonic neoplasms", - "Proctocolectomy", - "Hereditary cancer syndromes", - "Colorectal cancer screening", - "Colorectal adenomas", - "Preventive surgery for colorectal cancer", - "Gastrointestinal neoplasms", - "Cancer risk assessment", - "Genetic testing for hereditary cancer", - "Surveillance of individuals at risk for colorectal cancer", - "Endoscopic surveillance", - "Colorectal surgery", - "Minimally invasive surgery for colorectal disease", - "Hereditary colorectal cancer", - "Polyposis syndromes", - "Colonic neoplasia", - "Early detection of cancer", - "Cancer prevention", - "Genetic counseling for cancer", - "High-risk cancer screening", - "Colorectal neoplasms, hereditary nonpolyposis", - "Lynch syndrome", - "Peutz-Jeghers syndrome", - "Juvenile polyposis syndrome", - "MUTYH-associated polyposis" - ] - }, - "gpt-35-turbo": { - "summary": "The main medical problems of the patient include a family history of multiple polyps in older siblings, small colonic polyps within rectosigmoid, and benign adenomas.", - "conditions": [ - "Family history of multiple polyps", - "Small colonic polyps", - "Benign adenomas", - "Colonoscopy", - "Total proctocolectomy", - "Neoplasms", - "Sigmoidoscopy", - "Rectosigmoid" - ] - }, - "human_summary": "21-year-old male with dozens of small polyps found on colonoscopy. Family history significant for both older siblings having total colectomies after colonoscopy revealed hundreds of adenomas.", - "Clinician_B": [ - "FAP" - ], - "Clinician_C": [ - "Clinical Trial Family Colonic Adenomas" - ], - "Clinician_D": [ - "familial adenomatous polyposis trial", - "FAP syndrome trial", - "familial adenomatous polyposis proctocolectomy trial" - ] - }, - "sigir-201429": { - "raw": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", - "gpt-4-turbo": { - "summary": "A 51-year-old woman with a history of significant hypertension, diet-controlled diabetes mellitus, current smoking habit, and recent menopause is seeking advice on osteoporosis prevention to reduce the risk of hip fractures as she ages.", - "conditions": [ - "Osteoporosis", - "Hypertension", - "Diabetes Mellitus", - "Menopause", - "Smoking", - "Osteoporosis Prevention", - "Hip Fractures", - "Bone Density", - "Fracture Risk", - "Postmenopausal Osteoporosis", - "Cardiovascular Risk Factors", - "Nicotine Dependence", - "Dietary Management of Diabetes", - "Bone Health", - "Calcium Metabolism Disorders", - "Vitamin D Deficiency", - "Exercise for Osteoporosis", - "Hormone Replacement Therapy", - "Risk Reduction Behavior", - "Lifestyle Modification", - "Metabolic Syndrome", - "Insulin Resistance", - "Aging", - "Women's Health", - "Preventive Health Care", - "Bone Mineral Density", - "Secondary Osteoporosis", - "Endocrine Disorders", - "Smoking Cessation", - "Pharmacotherapy for Osteoporosis", - "Bisphosphonates", - "Selective Estrogen Receptor Modulators (SERMs)" - ] - }, - "gpt-35-turbo": { - "summary": "The main medical problems of the patient include osteoporosis, hypertension, diet-controlled diabetes mellitus, smoking, and menopause.", - "conditions": [ - "Osteoporosis", - "Hypertension", - "Diabetes mellitus", - "Smoking", - "Menopause", - "Hip fracture", - "Osteoporosis prevention", - "Postmenopausal osteoporosis", - "Hypertension management", - "Diabetes management", - "Smoking cessation", - "Bone health", - "Osteoporosis screening", - "Osteoporosis treatment", - "Osteoporosis risk factors", - "Osteoporosis prevention strategies", - "Osteoporosis medications", - "Lifestyle modifications for osteoporosis", - "Hormone replacement therapy for menopause", - "Cardiovascular risk in menopause", - "Effects of smoking on bone health", - "Effects of smoking on osteoporosis", - "Effects of smoking on cardiovascular health", - "Effects of menopause on bone health", - "Effects of menopause on cardiovascular health", - "Effects of hypertension on bone health", - "Effects of hypertension on osteoporosis", - "Effects of diabetes on bone health", - "Effects of diabetes on osteoporosis", - "Effects of diabetes on cardiovascular health", - "Osteoporosis prevention in menopause", - "Osteoporosis prevention in hypertension", - "Osteoporosis prevention in diabetes", - "Osteoporosis prevention in smokers" - ] - }, - "human_summary": "51-year-old smoker with hypertension and diabetes, in menopause, needs recommendations for preventing osteoporosis.", - "Clinician_B": [ - "osteoporosis diabetes", - "osteoporosis hypertension", - "osteoporosis menopause", - "osteoporosis smoking", - "osteoporosis 50 female" - ], - "Clinician_A": [ - "Bone densitiy after treatment of different forms of osteoporosis treatment" - ], - "Clinician_C": [ - "Osteoporosis Women", - "Osteoporosis Women Hypertension Diabetes Smoker" - ], - "Clinician_D": [ - "osteoporosis in menopausal women", - "osteoporosis prevention trial" - ] - }, - "sigir-20143": { - "raw": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", - "gpt-4-turbo": { - "summary": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough has a left lung mass and a solitary mass in the right frontal lobe.", - "conditions": [ - "Lung Neoplasms", - "Brain Neoplasms", - "Exertional Dyspnea", - "Cough", - "Solitary Pulmonary Nodule", - "Frontal Lobe Neoplasms", - "Metastatic Lung Cancer", - "Primary Lung Cancer", - "Metastatic Brain Cancer", - "Primary Brain Cancer", - "Non-Small Cell Lung Cancer", - "Small Cell Lung Cancer", - "Lung Cancer Suspected", - "Brain Metastasis", - "Non-smoker Lung Cancer", - "Pulmonary Mass", - "Cerebral Neoplasm", - "Asymptomatic Diseases", - "Thoracic Neoplasms", - "Cranial Neoplasms", - "Respiratory Tract Diseases", - "Neurologic Manifestations", - "Chest Pain", - "Shortness of Breath", - "Cancer Screening", - "Cancer Diagnosis", - "Oncology Patients", - "Radiation Therapy", - "Chemotherapy", - "Surgical Oncology", - "Targeted Therapy", - "Immunotherapy" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough. She has a left lung mass on chest x-ray and a solitary mass in the right frontal lobe on CT scan of the head.", - "conditions": [ - "Lung cancer", - "Brain metastasis", - "Exertional dyspnea", - "Cough", - "Solitary lung mass", - "Frontal lobe mass", - "Nonsmoker", - "White female", - "CT scan abnormalities", - "Asymptomatic", - "Neurologic examination", - "Chest x-ray abnormalities", - "Mild exertional dyspnea", - "Occasional cough", - "Solitary mass in frontal lobe", - "CT scan of head abnormalities", - "Metastatic lung cancer", - "Primary lung cancer", - "Brain tumor", - "Pulmonary mass", - "Respiratory symptoms", - "Pulmonary neoplasm", - "Chest imaging abnormalities", - "Brain imaging abnormalities", - "Lung mass on imaging", - "Solitary brain lesion", - "Metastatic brain tumor", - "Pulmonary malignancy", - "Respiratory distress", - "Coughing", - "Lung nodule", - "Brain lesion", - "Pulmonary lesion" - ] - }, - "human_summary": "58-year-old female non-smoker with left lung mass on x-ray. Head CT shows a solitary right frontal lobe mass.", - "Clinician_A": [ - "Metastatic brain tumours: Best Approach", - "Use of surgery, radiation or chemotherapy for metastatic brain tumours", - "Watchful waiting in brain tumours with unremarkable neurologic examinations" - ], - "Clinician_B": [ - "frontal lobe met trial", - "lung cancer", - "undifferentiated lung mass", - "ng mass CXR", - "Lung mass CXR" - ], - "Clinician_D": [ - "pulmonary nodule trial", - "solitary pulmonary nodule trial", - "undifferentiated lung mass trial" - ], - "Clinician_C": [ - "Clinical Trial CT Lung Mass", - "Clinical Trial CT Lung Mass solitary, cough and short of breath" - ] - }, - "sigir-201430": { - "raw": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", - "gpt-4-turbo": { - "summary": "A 72-year-old man with a history of myocardial infarction and transient ischemic attack presents with increasing calf pain when walking uphill, worsening blood pressure, a right carotid bruit, and diminished pulses in the lower extremities.", - "conditions": [ - "Peripheral arterial disease", - "Hypertension", - "Myocardial infarction history", - "Transient ischemic attack history", - "Carotid artery disease", - "Intermittent claudication", - "Blood pressure management", - "Ischemic heart disease", - "Stroke prevention", - "Carotid bruit", - "Lower extremity arterial disease", - "Cardiovascular risk factor management", - "Antihypertensive drug therapy", - "Aspirin therapy", - "Nitrate therapy", - "Antiplatelet therapy", - "Vascular insufficiency of the extremities", - "Chronic ischemia of the lower extremities", - "Walking impairment", - "Exercise-induced leg pain", - "Atherosclerosis", - "Coronary artery disease", - "Heart disease", - "Vascular health", - "Blood flow restriction", - "Lifestyle modification for cardiovascular health", - "Secondary prevention of myocardial infarction", - "Secondary prevention of stroke", - "Management of peripheral vascular diseases", - "Cool extremities", - "Diminished pedal pulses", - "Hypertensive heart disease" - ] - }, - "gpt-35-turbo": { - "summary": "The main medical problems of the patient include increasing calf pain when walking uphill, previous myocardial infarction, transient ischemic attack, worsening blood pressure, and diminished pulses in the lower extremities.", - "conditions": [ - "Peripheral artery disease", - "Atherosclerosis", - "Hypertension", - "Ischemic heart disease", - "Carotid artery stenosis", - "Intermittent claudication", - "Vascular insufficiency", - "Coronary artery disease", - "Angina", - "Stroke", - "Heart failure", - "Myocardial infarction", - "Transient ischemic attack", - "Vascular disease", - "Arterial occlusion", - "Aortic stenosis", - "Aortic valve disease", - "Cardiovascular disease", - "Cerebrovascular disease", - "Thrombosis", - "Embolism", - "Vascular occlusion", - "Vascular disorder", - "Ischemia", - "Aneurysm", - "Arteriosclerosis", - "Vascular blockage", - "Vascular obstruction", - "Vascular insufficiency", - "Vascular injury", - "Vascular inflammation", - "Vascular abnormality", - "Vascular disorder" - ] - }, - "human_summary": "72-year-old man with calf pain while walking uphill. History of ischemic heart disease and worsening hypertension despite medication compliance. On physical exam he has a right carotid bruit and his lower extremities are cool, with diminished dorsalis pedis pulses.", - "Clinician_B": [ - "peripheral arterial disease", - "cardiovascular disease" - ], - "Clinician_A": [ - "Peripheral vascular disease and possible therapies to prevent ischaemic limb" - ], - "Clinician_C": [ - "Calf Pain Excercise History of Myocardial infarct Hypertension polypharmacy" - ], - "Clinician_D": [ - "peripheral vascular disease trial", - "lower limb claudication trial", - "peripheral arterial disease trial" - ] - }, - "sigir-20144": { - "raw": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", - "gpt-4-turbo": { - "summary": "A 2-year-old boy presents with high fever, irritability, conjunctivitis, strawberry tongue, inflammation of the hands and feet, skin desquamation, cervical lymphadenopathy, abdominal tenderness with enlarged liver, elevated alanine aminotransferase, high white blood cell count, low albumin, high C-reactive protein, high erythrocyte sedimentation rate, mild normochromic normocytic anemia, leukocytes in urine without bacteria, and moderate dilation of the coronary arteries with possible coronary artery aneurysm.", - "conditions": [ - "Kawasaki disease", - "Coronary artery aneurysm", - "Conjunctivitis", - "Strawberry tongue", - "Skin desquamation", - "Cervical lymphadenopathy", - "High fever in children", - "Irritability in children", - "Inflammation of hands and feet", - "Elevated alanine aminotransferase", - "Leukocytosis", - "Hypoalbuminemia", - "Elevated C-reactive protein", - "Elevated erythrocyte sedimentation rate", - "Normochromic normocytic anemia", - "Leukocytes in urine", - "Abdominal tenderness", - "Hepatomegaly", - "Coronary artery dilation", - "Infectious diseases in children", - "Systemic inflammatory response", - "Pediatric emergency care", - "Pediatric cardiology", - "Vasculitis in children", - "Autoimmune diseases in children", - "Pediatric rheumatology", - "Fever of unknown origin in children", - "Acute phase reactants", - "Liver function tests", - "Pediatric infectious disease", - "Pediatric gastroenterology", - "Pediatric nephrology" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 2-year-old boy presenting with high fever, irritability, conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin, cervical lymphadenopathy, tenderness and enlarged liver, elevated liver enzymes, elevated white blood cell count, low albumin, elevated C-reactive protein, elevated erythrocyte sedimentation rate, mild anemia, leukocytes in urine, and moderate dilation of the coronary arteries with possible coronary artery aneurysm.", - "conditions": [ - "Kawasaki disease", - "High fever", - "Irritability", - "Conjunctivitis", - "Strawberry tongue", - "Inflammation of hands", - "Inflammation of feet", - "Desquamation of skin", - "Cervical lymphadenopathy", - "Tenderness", - "Enlarged liver", - "Elevated liver enzymes", - "Elevated white blood cell count", - "Low albumin", - "Elevated C-reactive protein", - "Elevated erythrocyte sedimentation rate", - "Mild anemia", - "Leukocytes in urine", - "Moderate dilation of coronary arteries", - "Coronary artery aneurysm", - "Fever", - "Abdominal pain", - "Skin rash", - "Joint pain", - "Fatigue", - "Headache", - "Vomiting", - "Diarrhea", - "Chest pain", - "Shortness of breath", - "Heart murmur", - "Myocarditis", - "Pericarditis" - ] - }, - "human_summary": "2-year-old boy with fever and irritability for 5 days. Physical exam findings include conjunctivitis, strawberry tongue, and desquamation of the fingers and toes. Lab results include low albumin, elevated white blood cell count and C-reactive protein, and urine leukocytes. Echo shows moderate dilation of the coronary arteries.", - "Clinician_B": [ - "Scarlet Fever Child Trial" - ], - "Clinician_A": [ - "First-line treatment for Scarlet fever in a child" - ], - "Clinician_D": [ - "kawasaki disease clinical trial", - "kawasaki clinical trial", - "kawasaki syndrome clinical trial", - "kawasaki IV IG clinical trial" - ], - "Clinician_C": [ - "Clinical Trial Child Fever conjunctivitis, Strawberry tongue, Infammed Hands Feet enlarged liver", - "Clinical Trial Fever conjunctivitis, Strawberry tongue, Infammed Hands Feet enlarged liver corpnary artery aneurysm" - ] - }, - "sigir-20145": { - "raw": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", - "gpt-4-turbo": { - "summary": "A 56-year-old female, 20 days post-left mastectomy, presents with shortness of breath, malaise, tenderness on the left upper thoracic wall and right calf, bilateral decreased breath sounds, especially at the right base, and an elevated D-dimer.", - "conditions": [ - "Post-mastectomy complications", - "Shortness of breath", - "Malaise", - "Tenderness in left upper thoracic wall", - "Tenderness in right calf", - "Decreased breath sounds", - "Elevated D-dimer", - "Risk of deep vein thrombosis", - "Risk of pulmonary embolism", - "Postoperative recovery", - "Venous thromboembolism", - "Pulmonary embolism", - "Deep vein thrombosis", - "Post-surgical complications", - "Breathlessness", - "Thrombosis", - "Postoperative venous thromboembolism", - "Immobility complications", - "Chest pain", - "Leg pain", - "Thromboembolic disease", - "Surgical recovery", - "Physical inactivity complications", - "Postoperative care", - "Anticoagulation therapy", - "Pulmonary function", - "Thromboprophylaxis", - "Breathing exercises", - "Physical rehabilitation", - "Pain management", - "Oxygen therapy", - "Anticoagulant treatment" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 56-year-old female who is 20 days post-left mastectomy and presents with shortness of breath and malaise. Physical examination reveals tenderness on the left upper thoracic wall and right calf. Pulmonary auscultation shows decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", - "conditions": [ - "Pulmonary embolism", - "Deep vein thrombosis", - "Postoperative complications", - "Thrombosis", - "Shortness of breath", - "Malaise", - "Tenderness on the left upper thoracic wall", - "Tenderness on the right calf", - "Decreased breath sounds", - "Elevated D-dimer", - "Mastectomy", - "Left mastectomy", - "Emergency department visit", - "Bed rest", - "Surgical incision", - "Bleeding", - "Infection", - "Physical examination", - "Pulmonary auscultation", - "Laboratory tests", - "D-dimer", - "Female", - "56 years old", - "Shortness of breath post-mastectomy", - "Malaise post-mastectomy", - "Tenderness on thoracic wall post-mastectomy", - "Tenderness on calf post-mastectomy", - "Decreased breath sounds post-mastectomy", - "Elevated D-dimer post-mastectomy", - "Postoperative complications post-mastectomy", - "Thrombosis post-mastectomy", - "Pulmonary embolism post-mastectomy", - "Deep vein thrombosis post-mastectomy" - ] - }, - "human_summary": "56-year-old woman presents with shortness of breath 3 weeks after surgical mastectomy. Physical exam is significant for right calf tenderness and decreased breath sounds at the right base. Her D-dimer level is elevated.", - "Clinician_B": [ - "DVT trial", - "Pulmonary Embolism Trial", - "Post-operative VTE trial" - ], - "Clinician_A": [ - "DVT occurence post surgery" - ], - "Clinician_D": [ - "pulmonary embolus clinical trial", - "post operative pulmonary embolus clinical trial", - "DVTPE clinical trial", - "pulmonary embolus heparin clinical trial", - "LMWH clinical trial" - ], - "Clinician_C": [ - "Clinical Trial post mastectomy Shortness of breath decreased breath sounds" - ] - }, - "sigir-20146": { - "raw": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", - "gpt-4-turbo": { - "summary": "64-year-old obese female with diabetes mellitus, persistently elevated HbA1c, non-compliance with diabetes medication and exercise, and a painful, oozing skin lesion on the left lower leg.", - "conditions": [ - "Diabetes Mellitus", - "Obesity", - "Elevated HbA1c", - "Medication Noncompliance", - "Exercise Noncompliance", - "Skin Lesions", - "Leg Ulcers", - "Diabetic Ulcers", - "Skin Infection", - "Chronic Ulcers", - "Wound Infection", - "Diabetic Dermopathy", - "Infection Control", - "Wound Healing", - "Pain Management", - "Diabetic Complications", - "Nutritional Management in Diabetes", - "Behavioral Interventions in Diabetes", - "Patient Education as Topic", - "Adherence to Treatment", - "Physical Activity", - "Weight Loss", - "Glycemic Control", - "Topical Antimicrobial Therapy", - "Topical Anti-Inflammatory Agents", - "Skin Care", - "Wound Care Management", - "Antibiotics", - "Anti-Infective Agents", - "Diabetes Education", - "Lifestyle Modification", - "Self-Management of Diabetes" - ] - }, - "gpt-35-turbo": { - "summary": "The main medical problems of the patient include obesity, diabetes mellitus with persistently elevated HbA1c, non-compliance with medication and exercise, and a painful skin lesion on the left lower leg.", - "conditions": [ - "Obesity", - "Diabetes mellitus", - "Elevated HbA1c", - "Non-compliance with medication", - "Non-compliance with exercise", - "Painful skin lesion", - "Leg ulcer", - "Oozing skin lesion", - "Skin infection", - "Cellulitis", - "Diabetic foot ulcer", - "Poor wound healing", - "Skin abscess", - "Diabetic neuropathy", - "Diabetic dermopathy", - "Diabetic foot infection", - "Diabetic foot pain", - "Diabetic foot care", - "Diabetic foot complications", - "Diabetic foot management", - "Diabetic foot ulcer treatment", - "Diabetic foot ulcer prevention", - "Diabetic foot ulcer management", - "Diabetic foot ulcer healing", - "Diabetic foot ulcer assessment", - "Diabetic foot ulcer dressing", - "Diabetic foot ulcer debridement", - "Diabetic foot ulcer antibiotics", - "Diabetic foot ulcer surgery", - "Diabetic foot ulcer offloading", - "Diabetic foot ulcer amputation", - "Diabetic foot ulcer clinical trial" - ] - }, - "human_summary": "64-year-old woman with uncontrolled diabetes, now with an oozing, painful skin lesion on her left lower leg.", - "Clinician_B": [ - "type two diabetes trial", - "diabetes poor adherence trial", - "diabetes poor compliance trial", - "diabetic ulcer trial" - ], - "Clinician_D": [ - "diabetic ulcer clinical trial", - "lower limb ulcer clinical trial", - "neuropathic ulcer clinical trial", - "ulcer dressing clinical trial", - "ulcer debridement clinical trial", - "ulcer antibiotics clinical trial", - "hyperbaric chamber clinical trial" - ], - "Clinician_C": [ - "Clinical Trial Diabetes Wound oozing not healing" - ], - "Clinician_A": [ - "Neurogenic ulcerations in non-compliant diabetes paitents" - ] - }, - "sigir-20147": { - "raw": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", - "gpt-4-turbo": { - "summary": "A 26-year-old obese woman with a history of bipolar disorder experiencing depression, anxiety, agitation, suicidal thoughts, sleep difficulties, and irritability. She is currently on lithium carbonate and zolpidem.", - "conditions": [ - "Bipolar Disorder", - "Obesity", - "Depression", - "Anxiety", - "Agitation", - "Suicidal Ideation", - "Sleep Disorders", - "Irritability", - "Restlessness", - "Mood Disorders", - "Mental Health Disorders", - "Weight Management", - "Eating Disorders", - "Psychiatric Disorder Comorbidity", - "Medication Management", - "Lithium Therapy", - "Zolpidem Therapy", - "Behavioral Symptoms", - "Stress", - "Emotional Disturbance", - "Cognitive Behavioral Therapy", - "Psychotherapy", - "Diet and Exercise", - "Lifestyle Modification", - "Sleep Hygiene", - "Anxiety Disorders", - "Depressive Disorder", - "Mood Stabilizers", - "Antidepressant Therapy", - "Sedative Therapy", - "Physical Activity", - "Psychological Support" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 26-year-old obese woman with a history of bipolar disorder. She is experiencing weight and eating struggles, depression, difficulty sleeping, excessive anxiety and agitation, thoughts of suicide, fidgetiness, and irritability. Her current medications include lithium carbonate and zolpidem.", - "conditions": [ - "Bipolar disorder", - "Obesity", - "Depression", - "Insomnia", - "Anxiety", - "Agitation", - "Suicidal ideation", - "Restlessness", - "Irritability", - "Weight management", - "Eating disorders", - "Mood disorders", - "Sleep disorders", - "Mental health", - "Psychiatric disorders", - "Bipolar depression", - "Bipolar disorder treatment", - "Obesity management", - "Depression treatment", - "Insomnia treatment", - "Anxiety treatment", - "Agitation treatment", - "Suicidal ideation treatment", - "Restlessness treatment", - "Irritability treatment", - "Lithium carbonate", - "Zolpidem", - "Pharmacotherapy for bipolar disorder", - "Psychiatric medication", - "Weight loss interventions", - "Cognitive-behavioral therapy for depression", - "Sleep disorder interventions", - "Mental health interventions" - ] - }, - "human_summary": "26-year-old obese woman with bipolar disorder, on zolpidem and lithium, with recent difficulty sleeping, agitation, suicidal ideation, and irritability.", - "Clinician_B": [ - "bipolar weight gain", - "mood stabilisers weight gain", - "insomnia bipolar", - "anxiety bipolar", - "suicide bipolar", - "lithium carbonate weight gain", - "zolpidem weight gain", - "lithium carbonate adverse effects", - "zolpidem adverse effects", - "lithium carbonate anxiety", - "zolpidem anxiety" - ], - "Clinician_D": [ - "bipolar disorder trial", - "lithium carbonate trial", - "zolpidem trial" - ], - "Clinician_C": [ - "Clinical Trial Bipolar Disorder Weight agitation", - "Clinical Trial Bipolar Lithium Zolpidem Agitation Depression Suicide" - ], - "Clinician_A": [ - "Drug interactions with lithium and zolpidem", - "Issues starting a new anti-depressants with lithiuim treatment", - "Lithium toxicity" - ] - }, - "sigir-20148": { - "raw": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", - "gpt-4-turbo": { - "summary": "A 62-year-old man with progressive memory loss, jerking movements of the lower extremities, severe cognitive deficits, generalized periodic sharp waves on EEG, moderately advanced cerebral atrophy, and cortical biopsy showing diffuse vacuolar changes of the gray matter with reactive astrocytosis.", - "conditions": [ - "Progressive memory loss", - "Cognitive deficits", - "Jerking movements", - "Generalized periodic sharp waves", - "Cerebral atrophy", - "Diffuse vacuolar changes", - "Reactive astrocytosis", - "Memory dysfunction", - "Neurodegenerative diseases", - "Cortical biopsy findings", - "Astrocytosis", - "Lower extremity movement disorder", - "EEG abnormalities", - "Vacuolar myelopathy", - "Gray matter diseases", - "Neurological movement disorders", - "Cognitive impairment", - "Brain atrophy", - "Neurological disorders", - "Dementia", - "Alzheimer's disease", - "Creutzfeldt-Jakob disease", - "Parkinson's disease", - "Huntington's disease", - "Prion diseases", - "Lewy body dementia", - "Frontotemporal dementia", - "Vascular dementia", - "Memory disorders", - "Neuropsychiatric symptoms", - "Neuroinflammation", - "Neuroimaging abnormalities" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 62-year-old man with progressive memory loss, jerking movements of the lower extremities, severe cognitive deficits, memory dysfunction, generalized periodic sharp waves on electroencephalogram, moderately advanced cerebral atrophy on neuroimaging studies, and diffuse vacuolar changes of the gray matter with reactive astrocytosis on cortical biopsy.", - "conditions": [ - "Progressive memory loss", - "Jerking movements of the lower extremities", - "Severe cognitive deficits", - "Memory dysfunction", - "Generalized periodic sharp waves on electroencephalogram", - "Moderately advanced cerebral atrophy on neuroimaging studies", - "Diffuse vacuolar changes of the gray matter with reactive astrocytosis on cortical biopsy" - ] - }, - "human_summary": "62-year-old man with progressive memory loss and involuntary leg movements. Brain MRI reveals cortical atrophy, and cortical biopsy shows vacuolar gray matter changes with reactive astrocytosis.", - "Clinician_B": [ - "Creutzfeldt-Jakob disease" - ], - "Clinician_D": [ - "dementia memory and motor symptoms trial", - "atrophic dementia motor symptoms trial", - "lower limb spasticity dementia" - ], - "Clinician_C": [ - "Clinical Trial Elderly Memory Loss Jerking Movements Lower limbs cerebral atrophy" - ], - "Clinician_A": [ - "Positive and negative prognostic factors associated with ALS", - "New technologies for treatment of ALS" - ] - }, - "sigir-20149": { - "raw": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", - "gpt-4-turbo": { - "summary": "A 43-year-old woman with multiple small, soft, pedunculated lesions on her neck, varying in color from flesh-colored to slightly hyperpigmented.", - "conditions": [ - "Skin lesions", - "Dermatologic lesions", - "Neck lesions", - "Soft tissue lesions", - "Hyperpigmentation", - "Skin neoplasms", - "Benign skin neoplasms", - "Cutaneous conditions", - "Papilloma", - "Acrochordon", - "Skin tags", - "Fibroepithelial polyps", - "Pedunculated lesions", - "Dermatology", - "Skin pigmentation disorders", - "Melanocytic nevi", - "Seborrheic keratosis", - "Human papillomavirus (HPV) related skin conditions", - "Benign neoplasms", - "Cutaneous papilloma", - "Fibroma", - "Skin tumor", - "Epidermal nevus", - "Dermatofibroma", - "Lipoma", - "Mole", - "Warts", - "Skin health", - "Skin examination", - "Skin biopsy", - "Dermatoscopy", - "Cosmetic dermatology" - ] - }, - "gpt-35-turbo": { - "summary": "The patient presents with multiple small soft and pedunculated lesions on her neck, varying in color from flesh colored to slightly hyperpigmented.", - "conditions": [ - "Skin lesions", - "Neck lesions", - "Pedunculated lesions", - "Flesh colored lesions", - "Hyperpigmented lesions", - "Dermatological conditions", - "Skin abnormalities", - "Skin growths", - "Skin tumors", - "Skin neoplasms", - "Skin nodules", - "Skin tags", - "Benign skin lesions", - "Benign skin tumors", - "Benign skin growths", - "Benign skin neoplasms", - "Benign skin nodules", - "Benign skin tags", - "Skin abnormalities on the neck", - "Soft skin lesions", - "Small skin lesions", - "Dermatological abnormalities", - "Dermatological growths", - "Dermatological tumors", - "Dermatological neoplasms", - "Dermatological nodules", - "Dermatological tags", - "Lesions on the neck", - "Soft lesions on the neck", - "Small lesions on the neck", - "Flesh colored lesions on the neck", - "Hyperpigmented lesions on the neck" - ] - }, - "human_summary": "43-year-old woman with soft, flesh-colored, pedunculated lesions on her neck.", - "Clinician_B": [ - "pedunculate lesion", - "pedunculated lesion" - ], - "Clinician_D": [ - "skin tag clinical trial", - "skin tag cryotherapy clinical trial" - ], - "Clinician_C": [ - "Clinical Trial Lesion Neck 4mm hyperpigmented multiple lesions" - ], - "Clinician_A": [ - "Benign vs Malignant skin lesions" - ] - }, - "sigir-20151": { - "raw": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", - "gpt-4-turbo": { - "summary": "A 44-year-old male presented to the emergency room with multiple bouts of vomiting with a 'coffee ground' appearance, tachycardia (heart rate of 135 bpm), hypotension (blood pressure of 70/40 mmHg), decreased mental status, and cool extremities. He received initial treatment with rapid crystalloid solution infusion and packed red blood cell transfusion and was admitted to the ICU.", - "conditions": [ - "Upper gastrointestinal bleeding", - "Hypovolemic shock", - "Tachycardia", - "Hypotension", - "Altered mental status", - "Acute blood loss anemia", - "Gastrointestinal hemorrhage", - "Peptic ulcer disease", - "Esophageal varices", - "Gastritis", - "Mallory-Weiss tear", - "Cool extremities", - "Vomiting", - "Emergency care", - "Intensive care unit admission", - "Fluid resuscitation", - "Blood transfusion", - "Critical care", - "Hemodynamic instability", - "Acid-base imbalance", - "Electrolyte imbalance", - "Shock", - "Acute kidney injury", - "Liver disease", - "Coagulopathy", - "Endoscopy", - "Helicobacter pylori infection", - "Non-steroidal anti-inflammatory drug use", - "Alcohol use disorder", - "Portal hypertension", - "Stress-related mucosal disease", - "Zollinger-Ellison syndrome" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 44-year-old male presenting with vomiting, coffee ground appearance, tachycardia, hypotension, decreased mental status, and cool extremities. He received crystalloid solution and packed red blood cell transfusion and was admitted to the ICU.", - "conditions": [ - "Gastrointestinal bleeding", - "Hypovolemic shock", - "Upper gastrointestinal bleeding", - "Peptic ulcer disease", - "Esophageal varices", - "Gastritis", - "Mallory-Weiss tear", - "Gastric ulcer", - "Duodenal ulcer", - "Gastroesophageal reflux disease", - "Gastric cancer", - "Esophageal cancer", - "Gastric volvulus", - "Gastric polyps", - "Gastric lymphoma", - "Gastric bezoar", - "Gastric outlet obstruction", - "Gastric volvulus", - "Gastric diverticulum", - "Gastric leiomyoma", - "Gastric leiomyosarcoma", - "Gastric neuroendocrine tumor", - "Gastric adenocarcinoma", - "Gastric lymphoma", - "Gastric carcinoid tumor", - "Gastric stromal tumor", - "Gastric duplication cyst", - "Gastric lipoma", - "Gastric teratoma", - "Gastric schwannoma", - "Gastric leiomyoblastoma", - "Gastric leiomyomatosis" - ] - }, - "human_summary": "A 44-year-old man with coffee-ground emesis, tachycardia, hypoxia, hypotension and cool, clammy extremities.", - "Clinician_B": [ - "haematemesis treatment", - "peptic ulcer treatment", - "peptic ulcer male actue treatment" - ], - "Clinician_A": [ - "PPI usage and the prevntion of further Peptic ulcer haemorrhage", - "First line treatment of peptic ulcer haemorrhage" - ], - "Clinician_C": [ - "Vomiting Coffe Ground", - "Vomiting Blood" - ], - "Clinician_D": [ - "peptic ulcer bleed trial", - "perforated peptic ulcer trial" - ] - }, - "sigir-201510": { - "raw": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", - "gpt-4-turbo": { - "summary": "A 38 year old woman with severe premenstrual and menstrual pelvic pain, heavy, irregular periods, occasional spotting between periods, history of infertility treatment for two years, and an ectopic pregnancy at age 26.", - "conditions": [ - "Premenstrual syndrome", - "Menstrual cramps", - "Heavy menstrual bleeding", - "Irregular menstruation", - "Spotting between periods", - "Infertility", - "Ectopic pregnancy", - "Pelvic pain", - "Dysmenorrhea", - "Menorrhagia", - "Menstrual disorders", - "Chronic pelvic pain", - "Endometriosis", - "Polycystic ovary syndrome", - "Uterine fibroids", - "Adenomyosis", - "Hormonal imbalance", - "Reproductive health", - "Gynecologic hemorrhage", - "Ovulatory dysfunction", - "Fallopian tube diseases", - "Pelvic inflammatory disease", - "Infertility treatments", - "Assisted reproductive technology", - "In vitro fertilization", - "Hysteroscopy", - "Laparoscopy", - "Menstrual cycle monitoring", - "Pain management", - "Hormone therapy", - "Gynecological surgery", - "Psychological aspects of infertility" - ] - }, - "gpt-35-turbo": { - "summary": "The main medical problems of the patient include severe premenstrual and menstrual pelvic pain, heavy, irregular periods, and occasional spotting between periods. The patient also has a history of infertility treatment and an ectopic pregnancy at age 26.", - "conditions": [ - "Pelvic pain", - "Premenstrual syndrome", - "Menstrual pain", - "Heavy periods", - "Irregular periods", - "Spotting between periods", - "Infertility", - "Ectopic pregnancy" - ] - }, - "human_summary": "A 38 year old woman with severe dysmenorrhea, menorrhagia, and menometrorrhagia. PMH of infertility treatment and ectopic pregnancy", - "Clinician_B": [ - "Endometriosis middle aged female" - ], - "Clinician_A": [ - "Early onset menopause" - ], - "Clinician_C": [ - "Premenstrual menstrual pelvic pain", - "Menstration severe pain irregular spotting" - ], - "Clinician_D": [ - "fibroids clinicial trial" - ] - }, - "sigir-201511": { - "raw": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", - "gpt-4-turbo": { - "summary": "A 56-year old Caucasian female presents with increased cold sensitivity, fatigue, decreased appetite, constipation, hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She exhibits slow movement and speech.", - "conditions": [ - "Hypothyroidism", - "Cold intolerance", - "Fatigue", - "Decreased appetite", - "Constipation", - "Hyporeflexia", - "Dry skin", - "Slow movement", - "Slow speech", - "Thyroid dysfunction", - "Autoimmune thyroiditis", - "Hashimoto's thyroiditis", - "Bradycardia", - "Myxedema", - "Peripheral neuropathy", - "Depression", - "Anemia", - "High cholesterol", - "Weight gain", - "Menopause", - "Vitamin D deficiency", - "Iron deficiency", - "Electrolyte imbalance", - "Sleep apnea", - "Chronic fatigue syndrome", - "Fibromyalgia", - "Hypogonadism", - "Adrenal insufficiency", - "Pituitary disorders", - "Celiac disease", - "Irritable bowel syndrome", - "Hypertension" - ] - }, - "gpt-35-turbo": { - "summary": "The main medical problems of the patient include sensitivity to cold, fatigue, decreased appetite, constipation, hyporeflexia, delayed relaxation of knee and ankle reflexes, dry skin, and slow movement and speech.", - "conditions": [ - "Hypothyroidism", - "Peripheral neuropathy", - "Dry skin", - "Constipation", - "Fatigue", - "Cold sensitivity", - "Hyporeflexia", - "Delayed relaxation of knee reflexes", - "Delayed relaxation of ankle reflexes", - "Slow movement", - "Slow speech", - "Thyroid dysfunction", - "Thyroid disorder", - "Thyroid hormone deficiency", - "Thyroid hormone imbalance", - "Thyroid gland dysfunction", - "Thyroid gland disorder", - "Thyroid hormone disorder", - "Thyroid hormone abnormality", - "Peripheral nerve disorder", - "Peripheral nerve dysfunction", - "Peripheral nerve damage", - "Dry skin condition", - "Dry skin disorder", - "Chronic constipation", - "Appetite loss", - "Cold intolerance", - "Reflex abnormality", - "Motor dysfunction", - "Speech impairment", - "Thyroid dysfunction symptoms", - "Peripheral neuropathy symptoms", - "Dry skin symptoms" - ] - }, - "human_summary": "A 56-year old Caucasian female presents with sensitivity to cold, fatigue, and constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin.", - "Clinician_B": [ - "Hypothyroidism", - "Hypothyroidism elderly", - "Hypothyroidism female" - ], - "Clinician_A": [ - "Experimental treatment for Guillian-Barre Syndrome", - "infection modalities for GBS" - ], - "Clinician_C": [ - "cold sesitivity fatigue decreased appetite constipation moves slowly" - ], - "Clinician_D": [ - "hypothyroidism clinical trial", - "thyroxine trial" - ] - }, - "sigir-201512": { - "raw": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", - "gpt-4-turbo": { - "summary": "A 44-year-old man sustained a skull fracture from an automobile accident, experienced clear fluid dripping from his nose, and later developed severe headache, fever, and nuchal rigidity.", - "conditions": [ - "Skull fracture", - "Cerebrospinal fluid leak", - "Severe headache", - "Fever", - "Nuchal rigidity", - "Traumatic brain injury", - "Meningitis", - "Post-traumatic headache", - "Basilar skull fracture", - "Intracranial infection", - "Post-traumatic meningitis", - "Head injury", - "Brain injury", - "Cranial nerve injuries", - "Encephalitis", - "Subarachnoid hemorrhage", - "Intracranial hemorrhage", - "Neurological infection", - "Craniofacial trauma", - "Neck pain", - "Brain abscess", - "Epidural hematoma", - "Subdural hematoma", - "Cranial neuropathy", - "Traumatic cerebrospinal fluid leak", - "Post-traumatic seizures", - "Cranial fracture", - "Neurosurgical emergency", - "Intracranial pressure increase", - "Brain edema", - "Neuroinflammation", - "Cranial surgery" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 44-year-old man who sustained a skull fracture in an automobile accident. He presented with clear fluid dripping from his nose, severe headache, fever, and nuchal rigidity.", - "conditions": [ - "Skull fracture", - "Cerebrospinal fluid leak", - "Headache", - "Fever", - "Nuchal rigidity" - ] - }, - "human_summary": "A 44-year-old man complains of severe headache and fever. Nuchal rigidity was found on physical examination.", - "Clinician_B": [ - "CSF rhinorrhea", - "CSF rhinorrhea trauma", - "CSF rhinorrhea trauma acute", - "CSF leak trauma acute" - ], - "Clinician_A": [ - "Emergency treatment Infective encephalitis from base of skull fracture" - ], - "Clinician_C": [ - "Skull Injury CSF Leaking Headache Fever" - ], - "Clinician_D": [ - "posttraumatic meningitis trial", - "bacterial meningitis trial", - "meningitis in head trauma trial", - "posttraumatic meningitis antibiotics trial" - ] - }, - "sigir-201513": { - "raw": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", - "gpt-4-turbo": { - "summary": "A 5-year-old boy with progressively worsening dysphagia, drooling, fever, vocal changes, toxic appearance, and a 'hot potato' voice. No history of foreign body ingestion or trauma. Vaccinations are delayed.", - "conditions": [ - "Dysphagia", - "Drooling", - "Fever", - "Vocal changes", - "Toxic appearance", - "Hot potato voice", - "Pediatric emergency", - "Vaccine delay", - "Infectious diseases in children", - "Upper respiratory infection", - "Epiglottitis", - "Airway obstruction", - "Pediatric otolaryngology", - "Retropharyngeal abscess", - "Peritonsillar abscess", - "Voice disorders in children", - "Pediatric infectious disease", - "Delayed vaccination effects", - "Pediatric fever of unknown origin", - "Acute infectious pharyngitis", - "Pediatric airway management", - "Bacterial infections in children", - "Viral infections in children", - "Pediatric emergency medicine", - "Pediatric intensive care", - "Sore throat in children", - "Emergency airway management", - "Pediatric sepsis", - "Pediatric inflammation", - "Pediatric immunization", - "Pediatric health", - "Childhood diseases" - ] - }, - "gpt-35-turbo": { - "summary": "The main medical problems of the patient include progressively worsening dysphagia, drooling, fever, vocal changes, toxic appearance, and delayed vaccines.", - "conditions": [ - "Epiglottitis", - "Retropharyngeal abscess", - "Peritonsillar abscess", - "Ludwig's angina", - "Bacterial tracheitis", - "Foreign body aspiration", - "Tonsillitis", - "Pharyngitis", - "Streptococcal infection", - "Viral infection", - "Mononucleosis", - "Diphtheria", - "Measles", - "Mumps", - "Rubella", - "Epstein-Barr virus infection", - "Herpangina", - "Hand, foot, and mouth disease", - "Scarlet fever", - "Kawasaki disease", - "Tuberculosis", - "Laryngitis", - "Croup", - "Vocal cord dysfunction", - "Gastroesophageal reflux disease (GERD)", - "Esophageal stricture", - "Esophageal foreign body", - "Esophageal tumor", - "Esophageal web", - "Esophagitis", - "Esophageal candidiasis", - "Esophageal varices", - "Esophageal diverticulum" - ] - }, - "human_summary": "A 5-year-old boy presents with difficulty in breathing, stridor, drooling, fever, dysphagia and voice change.", - "Clinician_B": [ - "Haemophilus influenzae", - "Haemophilus influenzae Child epiglottis" - ], - "Clinician_A": [ - "First line treatment of peritonsillar abscesses" - ], - "Clinician_C": [ - "Children Dysphagia Drooling vocal changes", - "Children Dysphagia Drooling vocal changes hot potato voice" - ], - "Clinician_D": [ - "epiglottitis clinical trial", - "epiglottitis antibiotic trial", - "epiglottitis in unvaccinated children" - ] - }, - "sigir-201514": { - "raw": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", - "gpt-4-turbo": { - "summary": "A 27-year-old pregnant woman with a history of mild iron deficiency, currently at 11 weeks gestation in her second pregnancy, presents with anemia (Hb of 9.0 g/dL initially, decreasing to 8.9 g/dL), thrombocytopenia (platelet count initially 119 x 109/L, decreasing to 108 x 109/L), elevated reticulocyte count (180 x 109/L), difficulty swallowing, elevated LDH (2000 IU/L), anisocytosis, poikilocytosis, polychromasia, and presence of hemosiderin in the urine. The direct antiglobulin test (DAT) is negative, and clotting screen, urea, electrolytes, and ALT are normal.", - "conditions": [ - "Pregnancy associated anemia", - "Iron deficiency anemia in pregnancy", - "Thrombocytopenia in pregnancy", - "Elevated reticulocyte count", - "Elevated lactate dehydrogenase (LDH)", - "Anisocytosis", - "Poikilocytosis", - "Polychromasia", - "Hemosiderinuria", - "Difficulty swallowing", - "Mild iron deficiency", - "Anemia in pregnancy", - "Second trimester pregnancy", - "Hemolytic anemia indicators", - "Negative direct antiglobulin test (DAT)", - "Normal clotting screen", - "Normal urea and electrolytes", - "Normal alanine aminotransferase (ALT)", - "Gestational thrombocytopenia", - "Maternal health in pregnancy", - "Nutritional deficiencies in pregnancy", - "Hematological changes in pregnancy", - "Reticulocytosis", - "Investigation of anemia in pregnancy", - "Investigation of thrombocytopenia in pregnancy", - "Management of iron deficiency in pregnancy", - "Elevated LDH in pregnancy", - "Anemia management in pregnancy", - "Thrombocytopenia management in pregnancy", - "Dysphagia in pregnancy", - "Pregnancy complications", - "Blood disorders in pregnancy" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 27-year-old pregnant woman with a hemoglobin level of 9.0 g/dL, mild iron deficiency, and elevated reticulocyte count. She also experiences difficulty swallowing and has elevated LDH levels.", - "conditions": [ - "Iron deficiency", - "Anemia", - "Thrombocytopenia", - "Difficulty swallowing", - "Elevated reticulocyte count", - "Elevated LDH levels", - "Anisocytosis", - "Poikilocytosis", - "Hemosiderin in urine", - "Pregnancy", - "Hemoglobin level", - "White blood cell count", - "Platelet count", - "Mean corpuscular volume", - "Negative DAT", - "Clotting screen", - "Urea and electrolytes", - "Alanine aminotransferase", - "Fragments", - "Agglutination", - "Polychromasia", - "Hemoglobinopathy", - "Thalassemia", - "Sickle cell disease", - "Autoimmune hemolytic anemia", - "Hemolytic uremic syndrome", - "Thrombotic thrombocytopenic purpura", - "Disseminated intravascular coagulation", - "Gastroesophageal reflux disease", - "Esophageal motility disorders", - "Esophageal stricture", - "Esophageal cancer", - "Gastrointestinal bleeding" - ] - }, - "human_summary": "A young woman in her second gestation presenting with anemia resistant to improvement by iron supplementation, elevated LDH, anisocytosis, poikilocytosis, hemosiderinuria and normal clotting screen.", - "Clinician_A": [ - "Autoimmune haemolytic anaemia in pregnancy" - ], - "Clinician_C": [ - "Pregnancy Iron defeciency", - "Pregnancy Iron defeciency resistant to iron supplementation" - ], - "Clinician_D": [ - "hemolytic anemia in pregnancy trial" - ] - }, - "sigir-201515": { - "raw": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", - "gpt-4-turbo": { - "summary": "Karen is a 72-year-old woman with a medical history of hypertension, type 2 diabetes, and a recent cryptogenic stroke. She has experienced occasional palpitations, shortness of breath, and chest pain. Her diagnostic tests including computed tomography, transesophageal echocardiogram, and magnetic resonance angiogram have shown no abnormalities.", - "conditions": [ - "Cryptogenic stroke", - "Hypertension", - "Type 2 diabetes", - "Palpitations", - "Shortness of breath", - "Chest pain", - "Stroke prevention", - "Post-stroke rehabilitation", - "Blood pressure management", - "Glucose level management", - "Cardiovascular disease", - "Atrial fibrillation", - "Transient ischemic attack", - "Stroke risk factors", - "Diabetes complications", - "Heart disease", - "Coronary artery disease", - "Peripheral artery disease", - "Vascular health", - "Heart rhythm disorders", - "Electrocardiogram abnormalities", - "Thrombolytic therapy", - "Anticoagulation therapy", - "Lifestyle modification for stroke prevention", - "Diet and diabetes management", - "Exercise for cardiovascular health", - "Stress management for heart health", - "Blood glucose monitoring", - "Hypoglycemia management", - "Hyperglycemia management", - "Insulin therapy", - "Oral hypoglycemic agents" - ] - }, - "gpt-35-turbo": { - "summary": "Karen is a 72-year-old woman with hypertension, type 2 diabetes, and a history of cryptogenic stroke. She currently presents with normal blood pressure, glucose, and sinus rhythm, but reports occasional palpitations, shortness of breath, and chest pain.", - "conditions": [ - "Cryptogenic stroke", - "Hypertension", - "Type 2 diabetes", - "Palpitations", - "Shortness of breath", - "Chest pain", - "Thrombolytic therapy", - "Computed tomography", - "Transesophageal echocardiogram", - "Magnetic resonance angiogram", - "Brain hemorrhage", - "Great vessel abnormalities", - "Sinus rhythm", - "Occasional symptoms" - ] - }, - "human_summary": "A 72-year-old woman with history of hypertension, type 2 diabetes, cryptogenic stroke, normal EKG, normal echocardiogram, normal angiograms, and complaints of occasional shortness of breath and palpitations.", - "Clinician_B": [ - "cryptogenic stroke elderly woman", - "hypertension stroke elderly woman", - "type two diabetes elderly woman", - "cryptogenic stroke thrombolytic therapy" - ], - "Clinician_A": [ - "Angina in patients with previous history of CVA" - ], - "Clinician_C": [ - "Stroke Hypertension Diabetes Thrombolytic", - "Stroke Hypertension Diabetes" - ], - "Clinician_D": [ - "atrial fibrillation trial", - "AF in cryptogenic stroke trial", - "AF stroke trial" - ] - }, - "sigir-201516": { - "raw": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", - "gpt-4-turbo": { - "summary": "A 4 year old boy with a history of allergic rhinitis presents with wheezing after playing in a sandbox. No prior history of wheezing. Wheezing is localized to the mid-right chest area, with O2 sats at 100% on room air.", - "conditions": [ - "Wheezing", - "Allergic rhinitis", - "Foreign body aspiration", - "Asthma", - "Respiratory distress", - "Bronchial obstruction", - "Pediatric emergency", - "Airway obstruction", - "Respiratory infection", - "Bronchospasm", - "Environmental allergy", - "Childhood asthma", - "Reactive airway disease", - "Pulmonary aspiration", - "Anaphylaxis", - "Allergy", - "Bronchitis", - "Pneumonia", - "Upper respiratory tract infection", - "Viral respiratory infections", - "Breathing difficulty", - "Cough", - "Inhalation injury", - "Air pollution exposure", - "Outdoor air quality", - "Sand exposure", - "Playground injuries", - "Pediatric respiratory diseases", - "Pediatric allergies", - "Emergency care", - "Oxygen therapy", - "Pulmonary function tests" - ] - }, - "gpt-35-turbo": { - "summary": "A 4 year old boy with wheezing and a history of allergic rhinitis", - "conditions": [ - "Wheezing", - "Allergic rhinitis", - "Coughing", - "Respiratory distress", - "Asthma", - "Bronchospasm", - "Airway obstruction", - "Allergies", - "Atopy", - "Inflammatory airway disease", - "Bronchial hyperresponsiveness", - "Respiratory infection", - "Viral infection", - "Exercise-induced bronchoconstriction", - "Environmental triggers", - "Allergen exposure", - "Atopic dermatitis", - "Eczema", - "Food allergies", - "Nasal congestion", - "Nasal itching", - "Sneezing", - "Nasal discharge", - "Nasal polyps", - "Sinusitis", - "Rhinosinusitis", - "Nasal obstruction", - "Nasal inflammation", - "Nasal swelling", - "Nasal congestion", - "Nasal itching", - "Sneezing", - "Nasal discharge" - ] - }, - "human_summary": "A 4 year old boy presents with wheezing after playing in the backyard unobserved.", - "Clinician_B": [ - "child asthma", - "allergic rhinitis asthma" - ], - "Clinician_A": [ - "Medical imaging for children with possible foreign body inhalation" - ], - "Clinician_C": [ - "Children Wheeze allergic rhinitis" - ], - "Clinician_D": [ - "asthma clinical trial", - "mild asthma clinical trial", - "salbutamol trial" - ] - }, - "sigir-201517": { - "raw": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", - "gpt-4-turbo": { - "summary": "A 32 year old female with no previous medical history, in general good health, presents with lab results from her most recent pap smear showing cytology negative but HPV positive.", - "conditions": [ - "HPV positive", - "Human Papillomavirus", - "Cervical HPV", - "HPV Infection", - "Asymptomatic HPV", - "Pap smear", - "Cervical screening", - "Women's health", - "Viral infections", - "Sexually transmitted diseases", - "HPV vaccination", - "Cervical cancer prevention", - "HPV management", - "HPV treatment", - "HPV screening", - "Preventive health care", - "Gynecological infection", - "Sexual health", - "Immunization for HPV", - "HPV-related diseases", - "Cervical dysplasia", - "Cervical health", - "HPV education", - "Public health", - "Infectious disease control", - "Vaccine research", - "Epidemiology of HPV", - "HPV transmission", - "HPV and pregnancy", - "Reproductive health", - "Women's reproductive health", - "HPV and fertility" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 32 year old female with no previous medical history. She presents with cytology negative, HPV positive results from her most recent pap smear.", - "conditions": [ - "HPV infection", - "Cervical dysplasia", - "Cervical cancer", - "Pap smear abnormalities", - "Cervical intraepithelial neoplasia", - "Human papillomavirus", - "Cervical screening", - "Cervical lesions", - "Cervical precancer", - "Cervical abnormalities", - "Cervical HPV infection", - "Cervical dysplasia screening", - "Cervical cancer screening", - "Pap smear screening", - "HPV testing", - "Cervical cancer prevention", - "Cervical cancer risk", - "Cervical cancer detection", - "Cervical cancer treatment", - "Cervical cancer management", - "Cervical cancer surveillance", - "Cervical cancer prognosis", - "Cervical cancer follow-up", - "Cervical cancer prevention strategies", - "Cervical cancer prevention methods", - "Cervical cancer prevention interventions", - "Cervical cancer prevention options", - "Cervical cancer prevention guidelines", - "Cervical cancer prevention recommendations", - "Cervical cancer prevention measures", - "Cervical cancer prevention approaches", - "Cervical cancer prevention programs", - "Cervical cancer prevention initiatives" - ] - }, - "human_summary": "A 32 year old female with screening that was positive for human papilloma virus with normal Pap smears.", - "Clinician_B": [ - "human papillomavirus" - ], - "Clinician_A": [ - "Risks of future cervical cancer with patients who are HPV positive" - ], - "Clinician_C": [ - "Papsmear HPV positive" - ], - "Clinician_D": [ - "HPV infection trial", - "hpv positive pap smear trial" - ] - }, - "sigir-201518": { - "raw": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", - "gpt-4-turbo": { - "summary": "A 65-year-old African-American male experiencing worsening exertional shortness of breath, orthopnea, bibasilar lung crackles, pitting ankle edema, and jugular venous distension over the past three weeks.", - "conditions": [ - "Heart failure", - "Exertional dyspnea", - "Orthopnea", - "Bibasilar lung crackles", - "Pitting ankle edema", - "Jugular venous distension", - "Chronic heart failure", - "Acute heart failure", - "Left ventricular dysfunction", - "Cardiomyopathy", - "Pulmonary edema", - "Congestive heart failure", - "Cardiac dysfunction", - "Hypertension", - "Coronary artery disease", - "African-American health disparities", - "Sleep-disordered breathing", - "Cardiovascular disease", - "Chronic obstructive pulmonary disease (COPD)", - "Atrial fibrillation", - "Valvular heart disease", - "Myocardial infarction history", - "Diabetes mellitus", - "Chronic kidney disease", - "Obesity", - "Hyperlipidemia", - "Smoking", - "Alcohol use", - "Physical inactivity", - "Diet and nutrition", - "Stress management", - "Medication adherence" - ] - }, - "gpt-35-turbo": { - "summary": "The main medical problems of the patient include shortness of breath related to exertion, difficulty breathing when lying flat, bibasilar lung crackles, pitting ankle edema, and jugular venous distension.", - "conditions": [ - "Heart failure", - "Pulmonary edema", - "Coronary artery disease", - "Hypertension", - "Asthma", - "Chronic obstructive pulmonary disease", - "Pulmonary hypertension", - "Valvular heart disease", - "Arrhythmia", - "Obstructive sleep apnea", - "Pulmonary embolism", - "Cardiomyopathy", - "Myocardial infarction", - "Pericardial effusion", - "Pleural effusion", - "Pneumonia", - "Pulmonary fibrosis", - "Lung cancer", - "Anemia", - "Renal failure", - "Liver disease", - "Thyroid disease", - "Diabetes", - "Obesity", - "Smoking", - "Alcohol abuse", - "Drug abuse", - "HIV/AIDS", - "Sarcoidosis", - "Systemic lupus erythematosus", - "Rheumatoid arthritis", - "Amyloidosis", - "Hemochromatosis" - ] - }, - "human_summary": "A 65-year-old African-American male with progressive dyspnea on exertion and while lying flat; bilateral pitting lower-extremity edema. The lungs revealed bilateral basilar crackles.", - "Clinician_B": [ - "congestive heart failure African-American", - "congestive heart failure elderly male", - "new diagnosis congestive heart failure" - ], - "Clinician_A": [ - "First line treatment for right sided heart failure in African-Americans" - ], - "Clinician_C": [ - "Shortness of breath on exertion sleep apnoea lung crackles pitting oedema", - "elderly Male Chronic heart failure" - ], - "Clinician_D": [ - "CHF trial", - "CCF trial", - "heart failure trial", - "diuretics heart failure trial", - "ACEi heart failure trial", - "ARBs heart failure trial", - "beta blockers heart failure trial" - ] - }, - "sigir-201519": { - "raw": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", - "gpt-4-turbo": { - "summary": "A 66-year-old female with a significant smoking history, chronic cough for the past two years, recent progressive shortness of breath, moderate respiratory distress after minimal exertion, mildly distended neck veins, barrel-shaped chest, and moderate inspiratory and expiratory wheezes.", - "conditions": [ - "Chronic Obstructive Pulmonary Disease (COPD)", - "Chronic Bronchitis", - "Emphysema", - "Tobacco Use Disorder", - "Respiratory Distress", - "Shortness of Breath", - "Chronic Cough", - "Smoking Cessation", - "Pulmonary Rehabilitation", - "Respiratory Failure", - "Lung Function Decline", - "Airway Obstruction", - "Bronchodilator Therapy", - "Inhaled Corticosteroids", - "Oxygen Therapy", - "Pulmonary Hypertension", - "Cardiovascular Risk", - "Exercise Intolerance", - "Quality of Life in COPD Patients", - "Anxiety in Chronic Illness", - "Depression in Chronic Illness", - "Sleep Disorders in COPD", - "Nutritional Status in COPD", - "Pulmonary Rehabilitation", - "Vaccination in COPD Patients", - "Systemic Inflammation in COPD", - "Acute Exacerbation of COPD", - "Noninvasive Ventilation", - "Long-term Oxygen Therapy", - "Palliative Care in COPD", - "End-of-Life Care in COPD", - "Telehealth for COPD Management" - ] - }, - "gpt-35-turbo": { - "summary": "The main medical problems of the patient include significant smoking history, chronic cough, recent progressive shortness of breath, moderate respiratory distress, mildly distended neck veins, barrel-shaped chest, and moderate inspiratory and expiratory wheezes.", - "conditions": [ - "Chronic obstructive pulmonary disease (COPD)", - "Emphysema", - "Chronic bronchitis", - "Asthma", - "Lung cancer", - "Pulmonary hypertension", - "Cor pulmonale", - "Chronic respiratory failure", - "Chronic cough", - "Shortness of breath", - "Respiratory distress", - "Smoking-related lung diseases", - "Barrel chest", - "Wheezing", - "Tobacco dependence", - "Nicotine addiction", - "Cigarette smoking", - "Tobacco use disorder", - "Pulmonary function impairment", - "Airway obstruction", - "Bronchial hyperresponsiveness", - "Chronic inflammation of the airways", - "Chronic mucus production", - "Chronic airflow limitation", - "Chronic respiratory symptoms", - "Chronic lung disease", - "Respiratory exacerbations", - "Lung function decline", - "Respiratory infections", - "Cough variant asthma", - "Smoking cessation", - "Pulmonary rehabilitation", - "Bronchodilator therapy" - ] - }, - "human_summary": "A 66-year-old female smoker presents with worsening dyspnea, productive chronic cough, moderate respiratory distress and unintentional weight loss.", - "Clinician_B": [ - "COPD", - "Acute Exacerbation of COPD", - "Smoking COPD" - ], - "Clinician_A": [ - "Treatment for moderate to severe COPD" - ], - "Clinician_C": [ - "Shortness of breath Smoker Chronic Cough Wheeze" - ], - "Clinician_D": [ - "cor pulmonale trial", - "COPD trial" - ] - }, - "sigir-20152": { - "raw": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", - "gpt-4-turbo": { - "summary": "A 62-year-old male with a history of being on immunosuppressive medications, including prednisone, presents with four days of non-productive cough and one day of fever. He is admitted to the hospital, and bronchoscopy with bronchoalveolar lavage (BAL) reveals owl's eye inclusion bodies in the nuclei of infected cells.", - "conditions": [ - "Immunosuppression", - "Non-productive cough", - "Fever", - "Prednisone use", - "Bronchoscopy", - "Bronchoalveolar lavage", - "Owl's eye inclusion bodies", - "Cytomegalovirus infection", - "Pneumonia", - "Viral infections", - "Infectious diseases", - "Lung infections", - "Respiratory infections", - "CMV pneumonia", - "Immunocompromised host", - "Antiviral agents", - "Ganciclovir", - "Valganciclovir", - "Foscarnet", - "Cidofovir", - "Leflunomide", - "Immunotherapy", - "Viral pneumonia", - "Respiratory failure", - "Acute respiratory distress syndrome", - "Pulmonary diseases", - "Infection control", - "Hospital-acquired infections", - "Nosocomial infections", - "Infectious disease management", - "Critical care", - "Respiratory therapy" - ] - }, - "gpt-35-turbo": { - "summary": "The main medical problems of the patient include a non-productive cough, fever, and the presence of owl's eye inclusion bodies in the nuclei of infection cells.", - "conditions": [ - "Respiratory infection", - "Immunosuppression", - "Non-productive cough", - "Fever", - "Owl's eye inclusion bodies", - "Bronchoscopy", - "Bronchoalveolar lavage", - "Prednisone", - "Viral infection", - "Pneumonia", - "Immunocompromised", - "Respiratory symptoms", - "Infection", - "Viral pneumonia", - "Immunosuppressive medications", - "Respiratory tract infection", - "Inclusion body", - "Respiratory distress", - "Respiratory failure", - "Pulmonary infection", - "Opportunistic infection", - "Viral respiratory infection", - "Respiratory virus", - "Lower respiratory tract infection", - "Severe respiratory infection", - "Viral bronchitis", - "Pulmonary infiltrates", - "Respiratory syncytial virus", - "Respiratory pathology", - "Respiratory illness", - "Respiratory complications", - "Respiratory distress syndrome", - "Respiratory virus infection" - ] - }, - "human_summary": "A 62-year-old immunosuppressed male with fever, cough and intranuclear inclusion bodies in bronchoalveolar lavage", - "Clinician_B": [ - "CMV" - ], - "Clinician_A": [ - "CMV treatment" - ], - "Clinician_C": [ - "Cough Fever Immunosupression Therapy", - "Cough Fever Immunosupression Therapy Reed-stenberg Cell" - ], - "Clinician_D": [ - "CMV pneumonia trial", - "CMV infection in immunosuppressed patient", - "CMV infection in immunocompromised patient", - "CMV pneumonia antiviral therapy trial", - "cytomegalovirus pneumonia trial" - ] - }, - "sigir-201520": { - "raw": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", - "gpt-4-turbo": { - "summary": "An 89-year-old man with six months of progressive cognitive and personality changes, including poor memory, difficulty expressing himself, unusual behaviors, inability to perform daily activities independently, irregular heart rhythm, difficulty with attention and following commands, speech issues with word substitutions, immediate recall present but no delayed recall, paratonic rigidity, myoclonic jerks, and brisk reflexes in arms.", - "conditions": [ - "Dementia", - "Cognitive decline", - "Personality changes", - "Memory impairment", - "Expressive language disorder", - "Behavioral changes", - "Dependence in daily activities", - "Irregular heart rhythm", - "Attention deficit", - "Speech disorder", - "Immediate recall", - "Delayed recall impairment", - "Paratonic rigidity", - "Myoclonic jerks", - "Brisk reflexes", - "Atrial fibrillation", - "Neurodegenerative disorders", - "Alzheimer's disease", - "Vascular dementia", - "Frontotemporal dementia", - "Lewy body dementia", - "Parkinson's disease", - "Geriatric psychiatry", - "Cerebrovascular accident (stroke)", - "Elderly care", - "Cognitive therapy", - "Speech therapy", - "Physical therapy", - "Occupational therapy", - "Psychogeriatrics", - "Neuropsychiatric symptoms", - "Movement disorders" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is an 89-year-old man with progressive changes in cognition and personality. He has poor memory, difficulty expressing himself, and exhibits unusual behaviors. He is unable to perform daily activities independently. On examination, he has an irregular heart rhythm, paratonic rigidity, and myoclonic jerks in the arms.", - "conditions": [ - "Cognitive impairment", - "Personality changes", - "Memory loss", - "Behavioral changes", - "Impaired activities of daily living", - "Irregular heart rhythm", - "Paratonic rigidity", - "Myoclonic jerks", - "Dementia", - "Alzheimer's disease", - "Frontotemporal dementia", - "Lewy body dementia", - "Vascular dementia", - "Parkinson's disease dementia", - "Creutzfeldt-Jakob disease", - "Normal pressure hydrocephalus", - "Huntington's disease", - "Progressive supranuclear palsy", - "Corticobasal degeneration", - "Multiple system atrophy", - "Posterior cortical atrophy", - "Mixed dementia", - "Mild cognitive impairment", - "Delirium", - "Depression", - "Anxiety", - "Stroke", - "Brain tumor", - "Infection", - "Metabolic disorder", - "Medication side effects", - "Vitamin deficiency", - "Thyroid dysfunction" - ] - }, - "human_summary": "An 89-year-old man with progressive change in personality, poor memory, and myoclonic jerks.", - "Clinician_B": [ - "dementia trial" - ], - "Clinician_A": [ - "Palliative care for end-stage Dementia", - "Experimental pharmacological treatment for Alzheimers" - ], - "Clinician_C": [ - "Geriatric Change in cognition Personality Poor memory" - ], - "Clinician_D": [ - "dementia trial" - ] - }, - "sigir-201521": { - "raw": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", - "gpt-4-turbo": { - "summary": "A 32-year-old male presents with diarrhea, abdominal cramping, flatulence, greasy and foul-smelling stools, loss of appetite, and malaise after drinking water from natural sources during a hiking trip. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", - "conditions": [ - "Giardiasis", - "Waterborne diseases", - "Parasitic infections", - "Diarrhea", - "Abdominal cramping", - "Flatulence", - "Steatorrhea", - "Malaise", - "Appetite loss", - "Intestinal protozoan infections", - "Gastrointestinal infections", - "Travel-related illnesses", - "Protozoal intestinal diseases", - "Gastrointestinal symptoms", - "Infectious diarrhea", - "Cryptosporidiosis", - "Amebiasis", - "Intestinal diseases", - "Gastroenteritis", - "Food and water related diseases", - "Hydration", - "Nutritional deficiencies", - "Immune response to infection", - "Environmental health", - "Public health", - "Infectious diseases", - "Parasitology", - "Microbiology", - "Epidemiology of parasitic diseases", - "Water purification", - "Outdoor health risks", - "Preventive medicine" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 32-year-old male presenting with diarrhea, abdominal cramping, flatulence, loss of appetite, malaise, and greasy, foul-smelling stools. He recently returned from a hiking trip where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", - "conditions": [ - "Giardiasis", - "Parasitic infection", - "Intestinal infection", - "Diarrhea", - "Abdominal cramping", - "Flatulence", - "Loss of appetite", - "Malaise", - "Greasy stools", - "Foul-smelling stools", - "Waterborne infection", - "Hiking-related infection", - "Iodine-stained stool smear", - "Ellipsoidal cysts", - "Smooth-walled cysts", - "Multiple nuclei in cysts", - "Protozoal infection", - "Intestinal parasite", - "Gastrointestinal symptoms", - "Water contamination", - "Travel-related infection", - "Infectious diarrhea", - "Gastrointestinal infection", - "Intestinal protozoa", - "Waterborne illness", - "Hiking-associated illness", - "Parasitic cysts", - "Intestinal cysts", - "Protozoal cysts", - "Waterborne parasite", - "Hiking-related parasite", - "Intestinal pathogen", - "Protozoal pathogen" - ] - }, - "human_summary": "A 32-year-old male presents with diarrhea and foul-smelling stools. Stool smear reveals protozoan parasites.", - "Clinician_B": [ - "Hydatid disease", - "Hydatid disease travel" - ], - "Clinician_A": [ - "Giardia prophylaxis", - "Giardia treatment", - "Usage of fenbendazole in humans for the treeatment of Giardia" - ], - "Clinician_C": [ - "Diarrhea abdominal Crampign Flatulence Greasy stool loss of appetite", - "Gastrointestinal untreated water" - ], - "Clinician_D": [ - "giardiasis trial", - "giardia trial", - "metronidazole trial" - ] - }, - "sigir-201522": { - "raw": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", - "gpt-4-turbo": { - "summary": "A 65-year-old male with a history of tuberculosis now presents with a productive cough with blood, a round opaque mass within a cavity in his left upper lobe that moves with position changes, and a sputum culture showing septated, low-angle branching hyphae with straight, parallel walls.", - "conditions": [ - "Aspergilloma", - "Pulmonary aspergillosis", - "Tuberculosis", - "Chronic pulmonary aspergillosis", - "Hemoptysis", - "Lung mass", - "Fungal lung infection", - "Aspergillosis", - "Pulmonary tuberculosis", - "Post-tuberculosis sequelae", - "Invasive aspergillosis", - "Chronic cough", - "Pulmonary fungal infection", - "Respiratory infection", - "Mycetoma", - "Fungal infection", - "Cavitary lung disease", - "Pulmonary hemorrhage", - "Respiratory tract infection", - "Chronic respiratory disease", - "Infectious lung disease", - "Mold infection", - "Pulmonary disease", - "Lung infection", - "Chronic lung disease", - "Pulmonary cavity", - "Respiratory fungal infection", - "Pulmonary nodule", - "Bronchopulmonary aspergillosis", - "Secondary pulmonary infection", - "Pulmonary complications", - "Cough with hemoptysis" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 65-year-old male with a history of tuberculosis presenting with a productive cough with tinges of blood. Chest X-ray shows a round opaque mass within a cavity in the left upper lobe. The spherical mass moves in the cavity during supine and prone CT imaging. Sputum culture reveals an organism with septated, low-angle branching hyphae and straight, parallel walls.", - "conditions": [ - "Cavitary lung lesion", - "Hemoptysis", - "Tuberculosis", - "Fungal infection", - "Pulmonary aspergillosis", - "Invasive aspergillosis", - "Pulmonary mycosis", - "Pulmonary nodule", - "Lung mass", - "Pulmonary cavity", - "Pulmonary infiltrate", - "Pulmonary tuberculosis", - "Pulmonary fungal infection", - "Pulmonary aspergilloma", - "Pulmonary aspergillosis", - "Pulmonary mycotic infection", - "Pulmonary mycosis", - "Pulmonary hyphae", - "Pulmonary septated hyphae", - "Pulmonary low-angle branching hyphae", - "Pulmonary straight-walled hyphae", - "Pulmonary mass with cavity", - "Pulmonary mass with moving spherical component", - "Pulmonary mass with mobile component", - "Pulmonary mass with mobile spherical component", - "Pulmonary mass with mobile spherical mass", - "Pulmonary mass with mobile mass", - "Pulmonary mass with mobile lesion", - "Pulmonary mass with mobile nodule", - "Pulmonary mass with mobile opacity", - "Pulmonary mass with mobile spot", - "Pulmonary mass with mobile growth" - ] - }, - "human_summary": "A 65-year-old male complains of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his lung. Culture of the sputum revealed fungal elements.", - "Clinician_B": [ - "Aspergillus trial" - ], - "Clinician_A": [ - "First line anti-fungals in the treatment of Aspergillosis" - ], - "Clinician_C": [ - "Tuberculosis X-ray Opaque mass" - ], - "Clinician_D": [ - "aspergillosis trial", - "aspergillus lung infection triak", - "aspergillosis tb patient trial" - ] - }, - "sigir-201523": { - "raw": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", - "gpt-4-turbo": { - "summary": "An 18-year-old male with sudden onset of high fever, chills, facial flushing, epistaxis, severe headache, joint pain, leukopenia, increased hematocrit concentration, and thrombocytopenia after returning from a vacation in Asia.", - "conditions": [ - "Dengue fever", - "Leukopenia", - "Thrombocytopenia", - "Increased hematocrit concentration", - "High fever", - "Chills", - "Facial flushing", - "Epistaxis", - "Severe headache", - "Joint pain", - "Travel-related infections", - "Viral hemorrhagic fevers", - "Infectious diseases", - "Tropical diseases", - "Arbovirus infections", - "Flavivirus infections", - "Mosquito-borne diseases", - "Acute febrile illness", - "Hematologic abnormalities", - "Systemic inflammatory response", - "Immune response in viral infections", - "Dehydration", - "Shock due to infection", - "Pain management in viral diseases", - "Fever of unknown origin", - "Emergency care in infectious diseases", - "Post-viral syndrome", - "Vector-borne diseases", - "Public health response to viral outbreaks", - "Epidemiology of infectious diseases", - "Preventive medicine in travel health", - "Global health issues" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is an 18-year-old male presenting with high fever, chills, facial flushing, epistaxis, severe headache, joint pain, leukopenia, increased hematocrit concentration, and thrombocytopenia.", - "conditions": [ - "Fever", - "Chills", - "Facial flushing", - "Epistaxis", - "Severe headache", - "Joint pain", - "Leukopenia", - "Increased hematocrit concentration", - "Thrombocytopenia", - "Infectious diseases", - "Viral infection", - "Bacterial infection", - "Dengue fever", - "Malaria", - "Typhoid fever", - "Japanese encephalitis", - "Chikungunya", - "Zika virus infection", - "Hemorrhagic fever", - "Meningitis", - "Encephalitis", - "Septicemia", - "Hemolytic anemia", - "Thrombocytopenic purpura", - "Leukemia", - "Lymphoma", - "Autoimmune disorders", - "Systemic lupus erythematosus", - "Rheumatoid arthritis", - "Hematological disorders", - "Thrombocytosis", - "Polycythemia", - "Leukocytosis" - ] - }, - "human_summary": "An 18-year-old male returned from Asia a week ago. He presents with high fever, severe headache and joint pain. His blood analysis reveals leukopenia, increased hematocrit and thrombocytopenia.", - "Clinician_B": [ - "Leptorpirosis", - "Leptorpirosis adolescent" - ], - "Clinician_A": [ - "Treatment in dengue fever of travellers" - ], - "Clinician_C": [ - "Travel Fever Chills epistaxis Joint pain Asia" - ], - "Clinician_D": [ - "dengue fever trial" - ] - }, - "sigir-201524": { - "raw": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", - "gpt-4-turbo": { - "summary": "A 31-year-old male with a recent history of cold symptoms, now presenting with productive cough, chest pain, fever, chills, and worsening cough. Physical examination reveals right-sided chest pain exacerbated by coughing, expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", - "conditions": [ - "Pneumonia", - "Acute bronchitis", - "Respiratory infection", - "Chest pain", - "Fever", - "Chills", - "Productive cough", - "Expiratory wheezing", - "Decreased breath sounds", - "Egophany", - "Viral respiratory infection", - "Bacterial pneumonia", - "Infectious disease", - "Pleuritic chest pain", - "Pleurisy", - "Community-acquired pneumonia", - "Influenza", - "COVID-19", - "Respiratory distress", - "Pulmonary infection", - "Bronchopneumonia", - "Lobar pneumonia", - "Respiratory failure", - "Sepsis", - "Acute respiratory distress syndrome (ARDS)", - "Pulmonary embolism", - "Respiratory syncytial virus (RSV) infection", - "Mycoplasma pneumoniae infection", - "Legionnaires' disease", - "Pneumocystis pneumonia (PCP)", - "Tuberculosis", - "Fungal pneumonia" - ] - }, - "gpt-35-turbo": { - "summary": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", - "conditions": [ - "Pneumonia", - "Bronchitis", - "Respiratory infection", - "Chest pain", - "Productive cough", - "Fever", - "Chills", - "Worsening cough", - "Right-sided chest pain", - "Expiratory wheezing", - "Decreased breath sounds", - "Egophany", - "Cold symptoms", - "Influenza", - "Upper respiratory tract infection", - "Lower respiratory tract infection", - "Viral infection", - "Bacterial infection", - "Lung infection", - "Pulmonary infection", - "Chest infection", - "Acute respiratory infection", - "Infectious disease", - "Respiratory distress", - "Respiratory symptoms", - "Cough", - "Feverish", - "Chills and fever", - "Chest discomfort", - "Pleuritic chest pain", - "Pulmonary consolidation", - "Lung consolidation", - "Respiratory distress syndrome" - ] - }, - "human_summary": "A 31 year old male presents with productive cough, chest pain, fever and chills. On exam he has audible wheezing with decreased breath sounds and dullness to percussion.", - "Clinician_B": [ - "Lung Consolidation Diagnosis", - "Lobar Pneumonia Middle Aged Male Trial" - ], - "Clinician_A": [ - "New antimicrobial treatment of pneumonias" - ], - "Clinician_C": [ - "Cough Chest pain on coughing Post viral" - ], - "Clinician_D": [ - "pneumonia trial", - "secondary bacterial pneumonia trial", - "community acquired pneumonia trial", - "pneumonia antibiotics trial" - ] - }, - "sigir-201525": { - "raw": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", - "gpt-4-turbo": { - "summary": "A 10-year-old boy presents with progressive right knee pain, fever, lethargy, edema and tenderness of the right thigh and knee, effusion, limited range of motion, and an osteolytic lesion on imaging.", - "conditions": [ - "Osteolytic lesions", - "Knee pain in children", - "Fever in children", - "Lethargy in children", - "Joint effusion", - "Limited range of motion", - "Pediatric osteomyelitis", - "Non-traumatic knee pain", - "Edema", - "Pediatric infectious diseases", - "Bone lesions in children", - "Pediatric rheumatology", - "Pediatric orthopedic disorders", - "Osteolysis", - "Pediatric fever of unknown origin", - "Acute lymphoblastic leukemia (ALL)", - "Ewing sarcoma", - "Osteosarcoma", - "Bone cancer in children", - "Pediatric emergency medicine", - "Pediatric pain management", - "Inflammatory diseases in children", - "Pediatric autoimmune diseases", - "Pediatric septic arthritis", - "Pediatric leukemia", - "Pediatric bone tumors", - "Pediatric sarcomas", - "Pediatric hematology", - "Pediatric oncology", - "Pediatric infectious arthritis", - "Pediatric critical care", - "Pediatric immunology" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 10-year-old boy presenting with right knee pain, fever, lethargy, edema, tenderness, effusion, and limited range of motion. Radiography and CT revealed an osteolytic lesion.", - "conditions": [ - "Osteolytic lesion", - "Knee pain", - "Fever", - "Lethargy", - "Edema", - "Tenderness", - "Effusion", - "Limited range of motion", - "Osteosarcoma", - "Osteomyelitis", - "Septic arthritis", - "Juvenile idiopathic arthritis", - "Leukemia", - "Lymphoma", - "Ewing sarcoma", - "Rheumatic fever", - "Lyme disease", - "Reactive arthritis", - "Hemophilia", - "Hemarthrosis", - "Synovial sarcoma", - "Gout", - "Pseudogout", - "Rheumatoid arthritis", - "Systemic lupus erythematosus", - "Osgood-Schlatter disease", - "Patellofemoral pain syndrome", - "Bursitis", - "Cellulitis", - "Deep vein thrombosis", - "Hypothyroidism", - "Sickle cell disease", - "Hemophilia A", - "Hemophilia B" - ] - }, - "human_summary": "10-year-old boy with progressive right knee and left leg pain and edema, lethargy and an osteolytic lesion. No history of trauma, fever, tachycardia, or urinary incontinence.", - "Clinician_B": [ - "osteomyeloma knee child" - ], - "Clinician_A": [ - "Osteosarcoma treatment modalities in the young", - "Osteosarcoma vaccination in humans" - ], - "Clinician_C": [ - "Childran Knee Pain atraumatic Fever Lethargy" - ], - "Clinician_D": [ - "septic arthritis trial" - ] - }, - "sigir-201526": { - "raw": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", - "gpt-4-turbo": { - "summary": "A 28-year-old female with a non-ruptured ectopic pregnancy, obesity, history of infertility treatment, past appendectomy, and pelvic laparoscopy for Fallopian tube adhesions. Her last menstrual period was 8 weeks prior to admission, and her Beta HCG level is 100 mIU.", - "conditions": [ - "Ectopic pregnancy", - "Obesity", - "Infertility", - "Fallopian tube adhesions", - "History of appendectomy", - "Laparoscopic surgery complications", - "Non-ruptured ectopic pregnancy management", - "Pelvic laparoscopy", - "Beta HCG level", - "Gynecologic surgical procedures", - "Adhesions", - "Pregnancy complications", - "Reproductive endocrinology", - "Minimally invasive surgery", - "Surgical outcomes in obese patients", - "Laparoscopy and obesity", - "Fertility preservation", - "Pregnancy after infertility treatment", - "Early pregnancy", - "Pregnancy management", - "Gynecologic conditions in obese patients", - "Surgical adhesions", - "Tubal pregnancy", - "Pregnancy diagnosis", - "Treatment options for ectopic pregnancy", - "Obesity and surgical risk", - "Laparoscopic adhesiolysis", - "Reproductive health", - "Women's health", - "Obstetrics", - "Gynecology", - "Surgical complications" - ] - }, - "gpt-35-turbo": { - "summary": "The main medical problems of the patient include non-ruptured ectopic pregnancy, obesity, history of appendectomy, infertility treatment, and pelvic laparoscopy with cauterization of right Fallopian tube adhesions.", - "conditions": [ - "Non-ruptured ectopic pregnancy", - "Obesity", - "History of appendectomy", - "Infertility treatment", - "Pelvic laparoscopy", - "Right Fallopian tube adhesions", - "Laparoscopic treatment", - "Beta HCG levels", - "Obese patients with ectopic pregnancy", - "Adhesions in obese patients", - "Laparoscopic surgery in obese patients", - "Management of non-ruptured ectopic pregnancy", - "Treatment options for ectopic pregnancy", - "Obesity and ectopic pregnancy", - "Complications of ectopic pregnancy", - "Surgical interventions for ectopic pregnancy", - "Adhesion formation after pelvic laparoscopy", - "Effect of obesity on ectopic pregnancy outcomes", - "Infertility treatment and ectopic pregnancy risk", - "Management of adhesions in obese patients", - "Laparoscopic techniques for obese patients", - "Preoperative evaluation in obese patients", - "Postoperative care for obese patients", - "Follow-up care for non-ruptured ectopic pregnancy", - "Role of beta HCG levels in ectopic pregnancy", - "Diagnostic methods for ectopic pregnancy", - "Risk factors for ectopic pregnancy", - "Prevention of ectopic pregnancy", - "Cauterization of Fallopian tube adhesions", - "Effectiveness of cauterization in adhesion prevention", - "Long-term outcomes of cauterization in adhesion prevention", - "Complications of cauterization in adhesion prevention", - "Evaluation of laparoscopic techniques in obese patients", - "Comparison of laparoscopic and open surgery for ectopic pregnancy", - "Effect of obesity on laparoscopic surgery outcomes" - ] - }, - "human_summary": "An obese 28 yo female with non-ruptured ectopic pregnancy and history of adhesions.", - "Clinician_B": [ - "non-ruptured ectopic pregnancy intervention", - "non-ruptured ectopic pregnancy adhesions", - "non-ruptured ectopic pregnancy infertility" - ], - "Clinician_A": [ - "Surgical alternatives for obese patietns requiring laparoscopic investigations and procedures" - ], - "Clinician_C": [ - "Ectopic Pregnancy management Laproscopic Obesity Adhesions" - ], - "Clinician_D": [ - "ectopic pregnancy nonsurgical management", - "ectopic pregnancy noninvasive management" - ] - }, - "sigir-201527": { - "raw": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", - "gpt-4-turbo": { - "summary": "A 15-year-old girl presents with excessive school absences, constant tiredness, easy fatigability, extremely pale skin and mucosae, a grade 3/6 systolic murmur, and abnormal lab findings including severe anemia (Hb: 4.2 g/dL), microcytic anemia (MCV 61.8 fL), and iron deficiency (serum iron < 1.8 umol/L, ferritin 2 ng/mL). Fecal occult blood test is negative.", - "conditions": [ - "Iron deficiency anemia", - "Microcytic anemia", - "Severe anemia", - "Fatigue", - "Systolic murmur", - "Pale skin", - "Tachycardia", - "Hypotension", - "Iron deficiency", - "Adolescent health", - "Nutritional deficiencies", - "Cardiovascular examination abnormal", - "Hemoglobin low", - "Ferritin low", - "Serum iron low", - "MCV low", - "Exercise intolerance", - "Sleepiness", - "School absenteeism", - "Easy fatigability", - "Anemia management", - "Iron supplementation", - "Blood transfusion", - "Dietary management", - "Physical activity impact on health", - "Chronic fatigue syndrome", - "Heart murmur", - "Pediatric anemia", - "Adolescent nutrition", - "Anemia in adolescents", - "Cardiac examination in anemia", - "Management of severe anemia in adolescents" - ] - }, - "gpt-35-turbo": { - "summary": "The main medical problems of the patient include excessive absences, constant tiredness and sleepiness, pale skin and mucosae, grade 3/6 systolic murmur, and low levels of hemoglobin, MCV, serum iron, and ferritin.", - "conditions": [ - "Anemia", - "Iron deficiency", - "Hemoglobinopathy", - "Systolic murmur", - "Pale skin", - "Fatigue", - "Sleepiness", - "Excessive absences", - "Low hemoglobin", - "Low MCV", - "Low serum iron", - "Low ferritin", - "Iron deficiency anemia", - "Microcytic anemia", - "Hypochromic anemia", - "Cardiac murmur", - "Tiredness", - "Weakness", - "Pallor", - "Iron metabolism disorder", - "Blood disorder", - "Iron deficiency in adolescent", - "Iron deficiency in teenager", - "Iron deficiency in young girl", - "Iron deficiency in female", - "Iron deficiency in child", - "Iron deficiency in pediatric patient", - "Iron deficiency in adolescent girl", - "Iron deficiency in teenager girl", - "Iron deficiency in young female", - "Iron deficiency in child girl", - "Iron deficiency in pediatric female" - ] - }, - "human_summary": "A 15 yo girl with fatigue, pale skin, low hemoglobin and ferritin.", - "Clinician_B": [ - "anemia adolescent" - ], - "Clinician_A": [ - "Haemic murmurs - How low is too low?", - "Severe anaemia in children - First line treatment" - ], - "Clinician_C": [ - "Teenage Female Fatigue Pale skin" - ], - "Clinician_D": [ - "hemolytic anemia trial" - ] - }, - "sigir-201528": { - "raw": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", - "gpt-4-turbo": { - "summary": "An 8-year-old boy presents with right lower extremity pain, fever, and limping for two days, with a history of a tick bite several months ago in Maryland. There is no history of trauma. Examination reveals a tender and swollen right knee. Laboratory tests show slightly elevated peripheral WBC count and SRP.", - "conditions": [ - "Lyme disease", - "Arthritis", - "Pediatric Lyme disease", - "Infectious Arthritis", - "Knee pain", - "Fever", - "Limping in children", - "Tick-borne diseases", - "Joint swelling", - "Elevated white blood cell count", - "Elevated sedimentation rate", - "Borrelia Infections", - "Right lower extremity pain", - "Knee injuries and disorders", - "Inflammation", - "Bacterial infections", - "Pediatric infectious diseases", - "Pediatric rheumatology", - "Autoimmune diseases", - "Vector-borne diseases", - "Knee osteoarthritis", - "Rheumatic diseases", - "Pain management", - "Orthopedic disorders", - "Pediatric orthopedics", - "Infectious disease medicine", - "Rheumatology", - "Pediatrics", - "Immunology", - "Public health", - "Epidemiology", - "Preventive medicine" - ] - }, - "gpt-35-turbo": { - "summary": "The main medical problems of the patient include right lower extremity pain, fever, limping, tender and swollen right knee, tick bite history, and slightly elevated peripheral WBC count and SRP.", - "conditions": [ - "Lyme disease", - "Tick-borne infection", - "Arthritis", - "Joint pain", - "Fever", - "Limping", - "Swollen knee", - "Tick bite", - "Erythema migrans", - "Peripheral WBC count elevation", - "SRP elevation", - "Infectious disease", - "Pediatric rheumatology", - "Inflammatory arthritis", - "Infectious arthritis", - "Septic arthritis", - "Osteomyelitis", - "Musculoskeletal infection", - "Bacterial infection", - "Viral infection", - "Autoimmune disease", - "Rheumatic disease", - "Inflammatory disorder", - "Pediatric orthopedics", - "Pediatric infectious diseases", - "Pediatric rheumatology", - "Pediatric orthopedic infections", - "Pediatric musculoskeletal infections", - "Pediatric bacterial infections", - "Pediatric viral infections", - "Pediatric autoimmune diseases", - "Pediatric rheumatic diseases" - ] - }, - "human_summary": "An 8-year-old boy presents with a swollen right knee, lower extremity pain and fever. The parents report no history of trauma. The parents noticed a tick bite several months earlier.", - "Clinician_A": [ - "Is lyme disease real is Australia?" - ], - "Clinician_C": [ - "Limb Pain Tick Bite" - ], - "Clinician_D": [ - "lyme disease trial" - ] - }, - "sigir-201529": { - "raw": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", - "gpt-4-turbo": { - "summary": "A 4-year-old girl with a week-long persistent fever peaking at 104F, erythematous rash on the trunk, strawberry red tongue, red and cracked lips, swollen red hands, and bilateral conjunctival injection without discharge.", - "conditions": [ - "Kawasaki disease", - "Fever of unknown origin", - "Pediatric fever", - "Erythematous rash", - "Strawberry tongue", - "Cracked lips", - "Hand swelling", - "Conjunctivitis", - "Vasculitis", - "Mucocutaneous lymph node syndrome", - "Infectious diseases", - "Systemic inflammatory response", - "Pediatric infectious diseases", - "Pediatric rheumatology", - "Autoimmune diseases", - "Inflammation", - "Pediatric emergency medicine", - "Rash", - "Fever in children", - "Pediatric dermatology", - "Pediatric cardiology", - "Coronary artery aneurysm", - "Immunology", - "Pediatric immunology", - "Acute febrile illness", - "Pediatric intensive care", - "Pediatric vasculitis", - "High fever", - "Pediatric acute care", - "Pediatric medicine", - "Emergency pediatrics", - "Pediatric infectious disease" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 4-year-old girl presenting with persistent fever, erythematous rash, strawberry red tongue, red and cracked lips, swollen red hands, and red eyes.", - "conditions": [ - "Fever", - "Erythematous rash", - "Strawberry red tongue", - "Red and cracked lips", - "Swollen red hands", - "Red eyes", - "Kawasaki disease", - "Fever of unknown origin", - "Viral infection", - "Bacterial infection", - "Autoimmune disease", - "Inflammatory disorder", - "Infectious disease", - "Pediatric fever", - "Pediatric rash", - "Pediatric infectious disease", - "Pediatric inflammatory disorder", - "Pediatric autoimmune disease", - "Pediatric Kawasaki disease", - "Pediatric fever of unknown origin", - "Pediatric viral infection", - "Pediatric bacterial infection", - "Pediatric rheumatology", - "Pediatric cardiology", - "Pediatric dermatology", - "Pediatric immunology", - "Pediatric infectious disease", - "Pediatric rheumatic fever", - "Pediatric vasculitis", - "Pediatric mucocutaneous lymph node syndrome", - "Pediatric coronary artery aneurysm", - "Pediatric systemic vasculitis" - ] - }, - "human_summary": "A 4-year-old girl with persistent high fever, skin rash, strawberry tongue, swollen red hands, and bilateral nonexudative conjunctivitis.", - "Clinician_B": [ - "Streptococcus pyogenes" - ], - "Clinician_A": [ - "Scarlet fever treatment in the very young", - "vaccination trials for scarlet fever" - ], - "Clinician_C": [ - "Persistent Fever strawberry tongue red lips" - ], - "Clinician_D": [ - "scarlet fever trial" - ] - }, - "sigir-20153": { - "raw": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", - "gpt-4-turbo": { - "summary": "A 65-year-old male with acute onset of shortness of breath, tachypnea, and left-sided chest pain worsening with inspiration, post right total hip replacement. Notable for delayed physical therapy and rehabilitation due to poor pain management, presenting with a high respiratory rate and right calf pain.", - "conditions": [ - "Pulmonary embolism", - "Deep vein thrombosis", - "Postoperative complications", - "Chest pain", - "Shortness of breath", - "Tachypnea", - "Hip replacement", - "Pain management", - "Rehabilitation", - "Physical therapy", - "Venous thromboembolism", - "Acute respiratory distress", - "Post-surgical pain", - "Delayed physical therapy", - "Orthopedic surgery complications", - "Anticoagulation therapy", - "Thrombolytic therapy", - "Respiratory failure", - "Venous thrombosis", - "Pulmonary rehabilitation", - "Mobility issues post-surgery", - "Postoperative pain control", - "Leg pain", - "Cardiopulmonary assessment", - "Risk factors for deep vein thrombosis", - "Risk factors for pulmonary embolism", - "Postoperative mobility", - "Anticoagulant prophylaxis", - "Surgical recovery", - "Physical inactivity post-surgery", - "Breathing exercises", - "Calf pain" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 65-year-old male with no significant history of cardiovascular disease. He presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. He recently underwent a right total hip replacement and experienced delayed initiation of physical therapy and rehabilitation due to poor pain management. Physical exam findings include a respiratory rate of 35 and right calf pain.", - "conditions": [ - "Pulmonary embolism", - "Deep vein thrombosis", - "Postoperative complications", - "Acute respiratory distress syndrome", - "Pneumonia", - "Pleurisy", - "Pulmonary edema", - "Pulmonary hypertension", - "Pulmonary embolism prophylaxis", - "Venous thromboembolism", - "Hip replacement complications", - "Thrombosis", - "Respiratory distress", - "Chest pain", - "Tachypnea", - "Shortness of breath", - "Pain management", - "Physical therapy", - "Rehabilitation", - "Respiratory rate abnormalities", - "Calf pain", - "Cardiovascular disease", - "Right total hip replacement", - "Delayed initiation of physical therapy", - "Poor pain management", - "Respiratory symptoms", - "Chest symptoms", - "Orthopedic surgery complications", - "Postoperative pain", - "Postoperative rehabilitation", - "Postoperative complications", - "Postoperative respiratory distress", - "Postoperative calf pain" - ] - }, - "human_summary": "A 65-year-old male presents with dyspnea, tachypnea, chest pain on inspiration, and swelling and pain in the right calf.", - "Clinician_B": [ - "post orthopaedic surgery chest pain", - "postoperative chest pain", - "postoperative hip replacement chest pain" - ], - "Clinician_A": [ - "Emergency treatment of pulmonary embolisms" - ], - "Clinician_C": [ - "Acute Shortness of breathe Left-sided chest pain Inspiration post op", - "Acute Shortness of breathe Left-sided chest pain Inspiration post op calf pain" - ], - "Clinician_D": [ - "pulmonary embolus trial", - "VTE trial", - "DVTPE trial", - "pulmonary thromboembolus trial", - "PE anticoagulation therapy trial", - "PE low molecular weight heparin trial", - "PE LMWH trial" - ] - }, - "sigir-201530": { - "raw": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", - "gpt-4-turbo": { - "summary": "A 47 year old male presents with pain, bruising, swelling, and inability to bend the arm after falling on it. X-ray shows posterior dislocation of the ulna from the trochlea of the humerus and dislocation of the radius from the capitulum of the humerus.", - "conditions": [ - "Elbow dislocation", - "Ulnar dislocation", - "Radial dislocation", - "Posterior elbow dislocation", - "Arm pain", - "Bruising", - "Swelling", - "Limited range of motion", - "Elbow injury", - "Traumatic injury", - "Orthopedic injuries", - "Joint dislocation", - "Elbow trauma", - "Soft tissue injury", - "Bone dislocation", - "Elbow swelling", - "Arm injury", - "Physical rehabilitation", - "Pain management", - "Orthopedic rehabilitation", - "Sports injury", - "Fall injuries", - "Upper extremity injuries", - "Elbow joint dislocation", - "Non-surgical treatment of elbow dislocation", - "Surgical treatment of elbow dislocation", - "Physical therapy for elbow dislocation", - "Occupational therapy for arm injuries", - "Pain relief for elbow injuries", - "Recovery from elbow dislocation", - "Elbow function restoration", - "Elbow ligament injury" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 47 year old male who fell on his outstretched left arm and presents with pain, bruising, swelling, and inability to bend the arm. X-ray shows dislocation of the ulna from the trochlea of the humerus and dislocation of the radius from the capitulum of the humerus.", - "conditions": [ - "Elbow dislocation", - "Ulna dislocation", - "Radius dislocation", - "Posterior ulna dislocation", - "Dislocated elbow", - "Elbow joint dislocation", - "Elbow trauma", - "Elbow injury", - "Elbow pain", - "Elbow swelling", - "Elbow bruising", - "Inability to bend arm", - "Ulna trochlea dislocation", - "Radius capitulum dislocation", - "Posterior ulna dislocation from trochlea", - "Dislocated ulna from humerus", - "Dislocated radius from humerus", - "Elbow joint instability", - "Elbow joint misalignment", - "Elbow joint subluxation", - "Elbow joint malalignment", - "Elbow joint dislocation treatment", - "Elbow joint dislocation management", - "Elbow joint dislocation therapy", - "Elbow joint dislocation rehabilitation", - "Elbow joint dislocation surgery", - "Elbow joint dislocation clinical trial", - "Elbow joint dislocation research", - "Elbow joint dislocation study", - "Elbow joint dislocation intervention", - "Elbow joint dislocation prevention", - "Elbow joint dislocation prognosis" - ] - }, - "human_summary": "A 47 year old male who fell on his outstretched left arm presents with pain, swelling, and inability to bend the arm. The x-ray, shows posterior elbow dislocation.", - "Clinician_B": [ - "traumatic proximal ulna and radial dislocation" - ], - "Clinician_A": [ - "Relocation efficacy of elbow dislocation", - "Arthritic changes after time post-dislocations" - ], - "Clinician_C": [ - "Trauma Upper limb Ulna Radius dislocation" - ], - "Clinician_D": [ - "elbow dislocation FOOSH trial" - ] - }, - "sigir-20154": { - "raw": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", - "gpt-4-turbo": { - "summary": "An 82-year-old woman with a history of hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis, and dementia presented with chest pain, shortness of breath, and elevated cardiac markers. Imaging and tests revealed severe segmental left ventricular dysfunction, mild mitral regurgitation, and no coronary artery stenosis.", - "conditions": [ - "Acute coronary syndrome", - "Hypertension", - "Renal artery stenosis", - "Chronic renal insufficiency", - "Hypercholesterolemia", - "Osteoporosis", - "Dementia", - "Chest pain", - "Shortness of breath", - "Substernal chest pain", - "Radiating chest pain", - "Elevated CK-MB", - "Elevated Troponin T", - "Sinus tachycardia", - "ST-segment elevation", - "Right basilar subsegmental atelectasis", - "Severe segmental left ventricular dysfunction", - "Mild mitral regurgitation", - "Left ventricular systolic dysfunction", - "Akinesis of the anterior wall", - "Hypokinesis of the apical and distal inferior walls", - "Compensatory hyperkinesis", - "Mildly impaired left ventricular systolic function", - "Anteroseptal territory dysfunction", - "Apex dysfunction", - "No coronary artery stenosis", - "High blood pressure", - "Rapid heart rate", - "Low lung volumes", - "Elevated cardiac enzymes", - "Cardiac imaging abnormalities", - "Mitral valve dysfunction" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is an 82-year-old woman with chest pain and shortness of breath. She has a history of hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis, and dementia. Physical examination and diagnostic tests reveal elevated blood pressure, rapid heart rate, ST-segment elevations on EKG, akinesis and hypokinesis of the ventricular walls on ventriculography, and severe segmental left ventricular dysfunction on echocardiogram.", - "conditions": [ - "Chest pain", - "Shortness of breath", - "Hypertension", - "Renal-artery stenosis", - "Chronic renal insufficiency", - "Hypercholesterolemia", - "Osteoporosis", - "Dementia", - "Elevated blood pressure", - "Rapid heart rate", - "ST-segment elevations on EKG", - "Akinesis of ventricular walls", - "Hypokinesis of ventricular walls", - "Severe segmental left ventricular dysfunction", - "Mildly impaired left ventricular systolic function", - "Mild mitral regurgitation", - "Substernal chest pain", - "Radiating chest pain", - "Left shoulder pain", - "Jaw pain", - "Respiratory rate", - "Oxygen saturation", - "Sinus regular tachycardia", - "ST-segment elevations in V1", - "ST-segment elevations in V2", - "ST-segment elevations in V3", - "Low lung volumes", - "Right basilar subsegmental atelectasis", - "Coronary angiography", - "Ventriculography", - "Transthoracic echocardiogram" - ] - }, - "human_summary": "82-year-old woman awakened by acute stabbing chest pain, with ST-segment elevation, hypertension, sinus tachycardia, no diseases on coronary angiography and left ventricular dysfunction on ventriculography.", - "Clinician_B": [ - "renal artery stenosis STEMI", - "renal-artery stenosis", - "hypercholesterolemia", - "osteoporosis elderly woman", - "dementia elderly woman", - "renal artery stenosis MI", - "Type 2 MI" - ], - "Clinician_A": [ - "Rehabilition modalities for severe IHD" - ], - "Clinician_C": [ - "Chest Pain SOB Hypertension renal insuffeciency" - ], - "Clinician_D": [ - "anterior MI trial" - ] - }, - "sigir-20155": { - "raw": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", - "gpt-4-turbo": { - "summary": "A 31-year-old woman presents with a 2-week history of joint pain, fatigue, intermittent fevers, and chest pain. Initially, she experienced right ankle swelling and difficulty standing and walking, which resolved after a few days. Recently, she has had pain, swelling, and stiffness in her knees, hips, and right elbow.", - "conditions": [ - "Joint pain", - "Fatigue", - "Intermittent fevers", - "Chest pain", - "Ankle swelling", - "Difficulty standing", - "Difficulty walking", - "Knee pain", - "Hip pain", - "Elbow pain", - "Joint swelling", - "Joint stiffness", - "Systemic inflammatory response", - "Rheumatoid arthritis", - "Systemic lupus erythematosus", - "Psoriatic arthritis", - "Ankylosing spondylitis", - "Infectious arthritis", - "Lyme disease", - "Reactive arthritis", - "Viral arthritis", - "Autoimmune diseases", - "Fever of unknown origin", - "Costochondritis", - "Pericarditis", - "Myocarditis", - "Polyarthritis", - "Spondyloarthritis", - "Inflammatory arthritis", - "Connective tissue disease", - "Septic arthritis", - "Vasculitis" - ] - }, - "gpt-35-turbo": { - "summary": "A 31-year-old woman with joint pain, fatigue, ankle swelling, difficulty standing up and walking, pain, swelling and stiffness in knees, hips and right elbow, intermittent fevers, and chest pain.", - "conditions": [ - "Joint pain", - "Fatigue", - "Ankle swelling", - "Difficulty standing up", - "Difficulty walking", - "Knee pain", - "Hip pain", - "Elbow pain", - "Fever", - "Chest pain", - "Arthritis", - "Rheumatoid arthritis", - "Systemic lupus erythematosus", - "Lyme disease", - "Gout", - "Osteoarthritis", - "Septic arthritis", - "Reactive arthritis", - "Psoriatic arthritis", - "Inflammatory arthritis", - "Viral arthritis", - "Autoimmune disease", - "Infection", - "Connective tissue disease", - "Vasculitis", - "Spondyloarthritis", - "Rheumatic fever", - "Fibromyalgia", - "Bursitis", - "Tendinitis", - "Osteomyelitis", - "Osteoporosis" - ] - }, - "human_summary": "Young adult woman with 2 weeks of fever and migrating joint inflammation.", - "Clinician_B": [ - "polyarthritis" - ], - "Clinician_A": [ - "polymyalgia treatment in the setting of viral infection" - ], - "Clinician_C": [ - "Joint Pain Fatigue Fever Stiffness" - ], - "Clinician_D": [ - "migratory arthritis trial", - "migratory polyarthritis trial", - "acute polyarthritis trial", - "rheumatic fever trial" - ] - }, - "sigir-20156": { - "raw": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", - "gpt-4-turbo": { - "summary": "A 46-year-old woman with a 9-month history of weight loss, sweating, insomnia, diarrhea, increased appetite, tachycardia, warm and sweaty hands, hyperreflexia, and mild exophthalmos.", - "conditions": [ - "Hyperthyroidism", - "Graves' Disease", - "Weight Loss", - "Sweating", - "Insomnia", - "Diarrhea", - "Increased Appetite", - "Tachycardia", - "Hyperreflexia", - "Exophthalmos", - "Thyroid Disorder", - "Autoimmune Thyroid Disease", - "Thyrotoxicosis", - "Irregular Heartbeat", - "Endocrine Disorders", - "Metabolic Syndrome", - "Anxiety", - "Palpitations", - "Thyroid Eye Disease", - "Thyroid Nodule", - "Goiter", - "Thyroiditis", - "Heart Disease", - "Gastrointestinal Disorders", - "Nutritional and Metabolic Diseases", - "Sleep Disorders", - "Autonomic Nervous System Disorders", - "Eye Diseases", - "Nervous System Diseases", - "Cardiovascular Diseases", - "Immune System Diseases", - "Hormonal Imbalances" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 46-year-old woman presenting with weight loss, sweating, insomnia, diarrhea, increased appetite, palpitations, warm and sweaty hands, irregular pulse, hyperreflexia, and mild exophthalmia.", - "conditions": [ - "Hyperthyroidism", - "Graves' disease", - "Thyrotoxicosis", - "Thyroid storm", - "Autoimmune thyroid disease", - "Thyroid dysfunction", - "Thyroid hormone excess", - "Thyroid hormone imbalance", - "Thyroid disorder", - "Endocrine disorder", - "Metabolic disorder", - "Weight loss", - "Sweating", - "Insomnia", - "Diarrhea", - "Increased appetite", - "Palpitations", - "Warm and sweaty hands", - "Irregular pulse", - "Hyperreflexia", - "Exophthalmia", - "Tachycardia", - "Cardiac arrhythmia", - "Nervousness", - "Restlessness", - "Fatigue", - "Muscle weakness", - "Heat intolerance", - "Tremor", - "Goiter", - "Thyroid enlargement", - "Thyroid nodules", - "Thyroid antibodies" - ] - }, - "human_summary": "A 46-year-old woman with sweaty hands, exophthalmia, and weight loss despite increased eating.", - "Clinician_B": [ - "Hyperthyroidism", - "hyperthyroidism middle aged female" - ], - "Clinician_A": [ - "First line treatment of thyrotoxicosis", - "reversablity of graves exophthalmus" - ], - "Clinician_C": [ - "Weight loss Sweating insomnia diarrhoe long term increased appetite" - ], - "Clinician_D": [ - "hyperthyroidism trial", - "graves disease trial", - "radioiodine therapy trial", - "radioactive iodine therapy trial", - "graves disease thyroidectomy trial" - ] - }, - "sigir-20157": { - "raw": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", - "gpt-4-turbo": { - "summary": "A 20-year-old female college student presents with fatigue, increased sleep and appetite, difficulty concentrating, loss of interest in social activities, and feelings of guilt. Her physical exam and laboratory tests, including hemoglobin, hematocrit, and thyroid stimulating hormone, are within normal limits.", - "conditions": [ - "Depression", - "Major Depressive Disorder", - "Fatigue", - "Sleep Disorders", - "Appetite Disorders", - "Concentration Impairment", - "Social Withdrawal", - "Guilt", - "Mood Disorders", - "Anxiety", - "Stress", - "Adjustment Disorders", - "Psychological Distress", - "Emotional Disturbance", - "Behavioral Symptoms", - "Cognitive Symptoms", - "Affective Symptoms", - "Seasonal Affective Disorder", - "Dysthymia", - "Bipolar Disorder", - "Mental Health Wellness 1", - "Psychosocial Issues", - "Quality of Life", - "Sleep Disturbance", - "Eating Disorders", - "Anhedonia", - "Academic Concerns", - "Family Relationship Issues", - "Peer Relationship Issues", - "Self Esteem Issues", - "Life Satisfaction", - "Resilience" - ] - }, - "gpt-35-turbo": { - "summary": "The main medical problems of the patient include fatigue, increased sleep and appetite, difficulty concentrating, loss of interest in activities, and feelings of guilt.", - "conditions": [ - "Fatigue", - "Increased sleep", - "Increased appetite", - "Difficulty concentrating", - "Loss of interest in activities", - "Feelings of guilt", - "Depression", - "Major depressive disorder", - "Mood disorder", - "Anxiety", - "Generalized anxiety disorder", - "Stress", - "Chronic fatigue syndrome", - "Sleep disorders", - "Insomnia", - "Hypothyroidism", - "Thyroid dysfunction", - "Iron deficiency", - "Anemia", - "Vitamin deficiency", - "Eating disorders", - "Bipolar disorder", - "Attention deficit hyperactivity disorder", - "Chronic illness", - "Autoimmune disease", - "Inflammatory condition", - "Chronic pain", - "Fibromyalgia", - "Chronic stress", - "Post-traumatic stress disorder", - "Substance abuse", - "Medication side effects", - "Hormonal imbalance" - ] - }, - "human_summary": "A 22 year old female presents with changes in appetite and sleeping, fatigue, diminished ability to think or concentrate, anhedonia and feelings of guilt.", - "Clinician_B": [ - "Major depression young female", - "Major depression female", - "Major depression student" - ], - "Clinician_A": [ - "Atypical depression treatment modalities" - ], - "Clinician_C": [ - "Fatigue increased sleep appetite", - "College student Depression" - ], - "Clinician_D": [ - "depressive disorder trial", - "depression clinical trial", - "MDD trial", - "antidepressant therapy trial", - "SSRI clinical trial", - "depression CBT clinical trial" - ] - }, - "sigir-20158": { - "raw": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", - "gpt-4-turbo": { - "summary": "A 10-year-old boy experiencing nighttime snoring, pauses in breathing, restlessness with nighttime awakenings, declining grades, lack of attention, and excessive sleepiness during class.", - "conditions": [ - "Sleep Apnea, Pediatric", - "Snoring", - "Sleep Disordered Breathing", - "Obstructive Sleep Apnea", - "Restlessness", - "Sleep Disturbance", - "Attention Deficit Hyperactivity Disorder (ADHD)", - "Excessive Daytime Sleepiness", - "Pediatric Sleep Disorders", - "Nocturnal Awakenings", - "Behavioral Symptoms", - "Cognitive Dysfunction", - "Attention Deficit Disorders", - "Sleep Disorders", - "Hypersomnia", - "Fatigue", - "Respiratory Disturbances", - "Attention Problems", - "Behavioral Problems", - "Educational Problems", - "Child Development Disorders", - "Child Behavior", - "Child Psychology", - "Sleep Apnea Syndromes", - "Airway Obstruction", - "Breathing-Related Sleep Disorder", - "Sleep Initiation and Maintenance Disorders", - "Sleep Wake Disorders" - ] - }, - "gpt-35-turbo": { - "summary": "The main medical problems of the patient include nighttime snoring, pauses in breathing, restlessness with nighttime awakenings, declining grades, lack of attention, and excessive sleepiness during class.", - "conditions": [ - "Obstructive sleep apnea", - "Sleep-disordered breathing", - "Sleep disturbances", - "Sleep-related breathing disorders", - "Sleep-related movement disorders", - "Sleep-related disorders", - "Sleep disorders", - "Sleep apnea", - "Sleep disturbances in children", - "Sleep-related breathing disorders in children", - "Sleep-related movement disorders in children", - "Sleep-related disorders in children", - "Sleep disorders in children", - "Pediatric obstructive sleep apnea", - "Pediatric sleep-disordered breathing", - "Pediatric sleep disturbances", - "Pediatric sleep-related breathing disorders", - "Pediatric sleep-related movement disorders", - "Pediatric sleep-related disorders", - "Pediatric sleep disorders", - "Childhood obstructive sleep apnea", - "Childhood sleep-disordered breathing", - "Childhood sleep disturbances", - "Childhood sleep-related breathing disorders", - "Childhood sleep-related movement disorders", - "Childhood sleep-related disorders", - "Childhood sleep disorders", - "Pediatric sleep apnea", - "Childhood sleep apnea", - "Sleep problems in children", - "Pediatric sleep problems", - "Childhood sleep problems" - ] - }, - "human_summary": "A 10-year-old boy with difficulty concentrating, daytime sleepiness, and failure to thrive. The boy sleeps restlessly, snores, sweats, breathes heavily through his mouth and gasps in his sleep.", - "Clinician_B": [ - "Sleep cycle disorder child" - ], - "Clinician_A": [ - "Sleep apnoea in the young" - ], - "Clinician_C": [ - "Children Snoring Apnoeoa" - ], - "Clinician_D": [ - "sleep apnea clinical trial" - ] - }, - "sigir-20159": { - "raw": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", - "gpt-4-turbo": { - "summary": "A 10-year-old child presents with myalgia, cough, shortness of breath, low-grade fever, abdominal pain, diarrhea, cyanosis, slight stiffness of the neck, and marked periorbital edema. The child was previously diagnosed with a viral illness. The family had recently stayed on a farm with domestic pigs. Vital signs indicate fever, hypotension, tachycardia, and tachypnea. Lab results show leukocytosis with eosinophilia.", - "conditions": [ - "Viral infections", - "Eosinophilia", - "Myalgia", - "Cough", - "Shortness of breath", - "Fever", - "Abdominal pain", - "Diarrhea", - "Cyanosis", - "Neck stiffness", - "Periorbital edema", - "Leukocytosis", - "Hypotension", - "Tachycardia", - "Tachypnea", - "Pediatric infectious diseases", - "Zoonotic infections", - "Respiratory infections", - "Gastrointestinal infections", - "Systemic infections", - "Inflammatory response", - "Immune response", - "Pediatric emergency care", - "Viral pneumonia", - "Bacterial infections", - "Meningitis", - "Sepsis", - "Exposure to domestic pigs", - "Animal-borne diseases", - "Environmental exposure", - "Pediatric critical care", - "Infectious disease management" - ] - }, - "gpt-35-turbo": { - "summary": "The patient is a 10-year-old child presenting with myalgia, cough, and shortness of breath. They had a recent viral illness and a history of exposure to pigs on a farm. Physical exam findings include cyanosis, stiffness of the neck, and periorbital edema. Lab results show elevated WBC count with eosinophilia.", - "conditions": [ - "Respiratory distress", - "Eosinophilia", - "Cough", - "Shortness of breath", - "Myalgia", - "Fever", - "Abdominal pain", - "Diarrhea", - "Viral illness", - "Exposure to pigs", - "Cyanosis", - "Stiff neck", - "Periorbital edema", - "Elevated WBC count", - "Farm exposure", - "Pulmonary symptoms", - "Inflammatory response", - "Respiratory infection", - "Parasitic infection", - "Allergic reaction", - "Zoonotic disease", - "Eosinophilic pneumonia", - "Infectious disease", - "Pulmonary eosinophilia", - "Respiratory distress syndrome", - "Pulmonary edema", - "Pulmonary infiltrates", - "Pulmonary hypertension", - "Pulmonary fibrosis", - "Pulmonary embolism", - "Pulmonary hemorrhage", - "Pulmonary function impairment" - ] - }, - "human_summary": "A 10 year old child with recent history of pork consumption presents with fever, myalgia, facial edema and eosinophilia", - "Clinician_B": [ - "Trichinosis", - "Trichinosis child" - ], - "Clinician_A": [ - "First line treatment of leptospirosis", - "Common zoonotic pathogens from pigs and prevention" - ], - "Clinician_C": [ - "Children Myalgia cough fever farm pig exposure" - ], - "Clinician_D": [ - "trichinosis trial", - "trichinosis antiparasiticis trial" - ] - } -} \ No newline at end of file diff --git a/dataset/sigir/retrieved_trials.json b/dataset/sigir/retrieved_trials.json deleted file mode 100644 index 2da41c0..0000000 --- a/dataset/sigir/retrieved_trials.json +++ /dev/null @@ -1,57673 +0,0 @@ -[ - { - "patient_id": "sigir-20141", - "patient": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", - "0": [ - { - "brief_title": "Usefulness of Chest Wall Tenderness as Bedside Test to Exclude Acute Coronary Syndrome in Different Demographic Groups", - "phase": "", - "drugs": "['Clinical examination: chest wall tenderness']", - "drugs_list": [ - "Clinical examination: chest wall tenderness" - ], - "diseases": "['Chest Pain']", - "diseases_list": [ - "Chest Pain" - ], - "enrollment": "110.0", - "inclusion_criteria": "inclusion criteria: All patients over the age of 18 years presenting with the leading symptom of first time or recurrent acute chest pain in the emergency room of the Department of Internal Medicine, University Hospital of Zurich. \n\n ", - "exclusion_criteria": ": \n\n Missing informed consent. \n\n Cardiopulmonary unstable patients. \n\n No self reported chest pain. \n\n Recent thoracic surgery within1 year, inflammatory joint disease, fibromyalgia, cardiogenic shock.", - "brief_summary": "To determine the significance of a simple bedside clinical test (chest wall tenderness) to exclude myocardial ischemia in different demographic groups.", - "NCTID": "NCT01724996" - }, - { - "brief_title": "Understanding Pediatric Chest Pain and Other Symptoms", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chest Pain']", - "diseases_list": [ - "Chest Pain" - ], - "enrollment": "156.0", - "inclusion_criteria": "inclusion criteria: \n\n 8-18 years of age \n\n Pediatric patients with referrals for innocent heart murmurs \n\n Pediatric patients experiencing chest pain \n\n English speaking \n\n ", - "exclusion_criteria": ": \n\n Non English speaking patients", - "brief_summary": "The causes of pediatric pain are often not the same for every child. Most children who visit a cardiology specialist with complaints of chest or other somatic pain have no known medical diagnosis to explain their symptoms. These children and their families often leave with no explanation for the child's distress.~This early study will ask parents and children specific questions related to the stress in their lives, their emotional well-being and the children's physical functioning. The investigators want children who experience chest and other somatic pain, and those who do not, to be in their study so that they can look at both groups.~The investigators hope to use these answers to better inform cardiologists who often work with children with non-cardiac pain and, in turn, help them to better serve their patients. Ultimately, the investigators hope that the answers they get will provide answers to these families. They also hope to use the results of this study to put together a short screener for the cardiologist to give to pediatric patients with complaints of chest or other somatic pain to help the cardiologists better understand their patients' symptoms.", - "NCTID": "NCT00166231" - }, - { - "brief_title": "Treatment Study Comparing Manual Treatment or Advice in Acute, Musculoskeletal Chest Pain", - "phase": "", - "drugs": "['chiropractic treatment', 'Self-management']", - "drugs_list": [ - "chiropractic treatment", - "Self-management" - ], - "diseases": "['Musculoskeletal Chest Pain', 'Non-cardiac Chest Pain', 'Undiagnosed Chest Pain']", - "diseases_list": [ - "Musculoskeletal Chest Pain", - "Non-cardiac Chest Pain", - "Undiagnosed Chest Pain" - ], - "enrollment": "115.0", - "inclusion_criteria": "inclusion criteria: \n\n To be included in the project the participant must \n\n Have chest pain as their primary complaint. \n\n Have an acute episode of pain of less than 7 days duration before admission. \n\n Consent to the standardized evaluation program at the chest pain clinic. \n\n Have pain the in the thorax and/or neck. \n\n Be able to read and understand Danish. Be between 18 and 75 year of age. \n\n Be a resident of the Funen County. \n\n Patients will not be included if any of the following conditions are present \n\n ACS. \n\n Have had Percutaneous Coronary Intervention (PCI) or Coronary Artery By-pass Grafting (CABG). \n\n Have a condition that is likely to results in the episode of chest pain. The condition must be verified clinically during admission (i.e. pulmonary embolism, pneumonia, dissection of the aorta, \u2026). \n\n Inflammatory joint disease. \n\n Insulin dependent diabetes. \n\n Fibromyalgia. \n\n Malignant disease. \n\n Apoplexy, dementia, or unable to cooperate. \n\n Major osseous anomaly. \n\n Osteoporosis. \n\n Pregnancy. \n\n Does not want to participate. \n\n Other - the reason for non-inclusion will be registered. \n\n ", - "exclusion_criteria": ": \n\n Participants will be excluded following baseline evaluation if any of the following conditions are present \n\n Pain not related to the joints and muscles of the neck and/or thorax (CTA negative, see below). \n\n New incidence of any of the above mentioned conditions/pathologies.", - "brief_summary": "Acute chest pain is a common cause of hospital admission. Active approaches are directed towards diagnosis and treatment of potentially life threatening conditions, especially acute coronary syndrome and coronary artery disease. However, a considerable number of patients may have chest pain caused by biomechanical dysfunction of muscles and joints of the chest wall or the cervical and thoracic spine (20%). The diagnostic approaches and treatment options for this group of patients are scarce and there is a lack of formal clinical studies and validated outcome measures addressing the effect of manual treatment approaches.~Objective: This single blind randomized clinical trial investigates whether chiropractic treatment can reduce pain and improve function in a population of patients with acute, musculoskeletal chest pain when compared to advice directed towards promoting self-management.~Methods: Among patients admitted to a chest pain clinic in a university hospital under suspicion of acute coronary syndrome, 120 patients with an episode of acute chest pain of musculoskeletal origin are included in the study. All patients have completed the chest pain clinic diagnostic procedures, and acute coronary syndrome and other obvious reasons for chest pain have been excluded. After completion of the study evaluation program, the patients are randomized into one of two groups: A) advice promoting self-management and individual instructions focusing on posture and muscle stretch; B) a course of chiropractic therapy of up to ten treatment sessions focusing on high velocity, low amplitude manipulation of the cervical and thoracic spine together with a choice of mobilisation and soft tissue techniques. In order to establish suitable outcome measures, two pilot studies were conducted. Outcome measures are pain, function, overall health, and patient-rated treatment effect measured at 4, 12, and 52 weeks following treatment.", - "NCTID": "NCT00462241" - }, - { - "brief_title": "Chest Pain Observation Unit Risk Reduction Trial", - "phase": "", - "drugs": "['Full counseling', 'Minimal counseling']", - "drugs_list": [ - "Full counseling", - "Minimal counseling" - ], - "diseases": "['Chest Pain']", - "diseases_list": [ - "Chest Pain" - ], - "enrollment": "140.0", - "inclusion_criteria": "inclusion criteria: \n\n At least one modifiable cardiovascular risk factor (smoking, hyperlipidemia, hypertension, diabetes mellitus, obesity) \n\n ", - "exclusion_criteria": ": \n\n Patients who rule-in for myocardial ischemia at initial testing \n\n Terminally ill (expected to survive less than 3 months) \n\n Unavailable for 6-month follow-up \n\n Cannot be contacted by telephone \n\n Institutionalized persons (prisoners, nursing home residents) \n\n Unable to provide informed consent (impaired mental status, unable to speak English)", - "brief_summary": "The purpose of this study is to determine whether a brief counseling intervention initiated in the chest pain observation unit has a significant impact upon the health attitudes (readiness to change) and cardiovascular risk-related behaviors (diet, exercise, and smoking) of emergency department patients.", - "NCTID": "NCT00536224" - }, - { - "brief_title": "Non Cardiac Chest Pain and Benign Palpitations", - "phase": "Phase 4", - "drugs": "['Cognitive behaviour therapy']", - "drugs_list": [ - "Cognitive behaviour therapy" - ], - "diseases": "['Anxiety/Depression in Cardiological Unit']", - "diseases_list": [ - "Anxiety/Depression in Cardiological Unit" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n investigated for chest pain or palpitation 6 month ago at Cardiological Out-patient Clinic, Molde Hospital \n\n suffer of chest pain or palpitations \n\n ", - "exclusion_criteria": ": \n\n do not speak norwegian properly \n\n mentally retarded \n\n psychosis last 6 month \n\n current alcohol or drug misuse", - "brief_summary": "All Patients between 18 and 65 years are asked 6 month after investigation for chest pain or palpitation at Cardiological Out-patient Clinic, Molde Hospital, about if they still have symptoms of chest pain or palpitation. If they still have some of the symptoms they are invited to participate in a coping course to learn a better way to deal with their symptoms.~The coping course consist of three sessions of cognitive behaviour therapy.", - "NCTID": "NCT00623454" - }, - { - "brief_title": "Pain During Chest Tube Withdrawal: Evaluation Using Pan Monitor", - "phase": "", - "drugs": "['Chest drain withdrawal', 'Pain Monitor']", - "drugs_list": [ - "Chest drain withdrawal", - "Pain Monitor" - ], - "diseases": "['Chest Pain']", - "diseases_list": [ - "Chest Pain" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n patients undergoing removal of a chest tube after lung surgery, \n\n patients able to indicate the pain score. \n\n ", - "exclusion_criteria": ": \n\n pregnancy, lactation , \n\n insulin-dependent diabetes with dysautonomia, \n\n central or peripheral neurological disease, agitation, \n\n inability to understand the protocol, \n\n inability to use the Pain Monitor: skin abnormalities at the site of measurement, pacemaker or implantable defibrillator, condition affecting the sympathetic nervous system, tremor of the extremities, \n\n contra-indication to oral morphine , \n\n respiratory failure, severe hepatic insufficiency, intracranial hypertension, epilepsy associations \n\n recent administration of neostigmine or of atropine.", - "brief_summary": "Pain evaluation remains a clinical problem. Pain Monitor allows pain evaluation using the measurement of skin conductance.~Withdrawal of chest tube can be painful and the purpose of the study was to compare auto-evaluation of pain (visual analogic scale) and the index measured by the Pain Monitor.", - "NCTID": "NCT02015858" - }, - { - "brief_title": "Home Hypnotherapy for Refractory Functional Chest Pain: A Pilot Study", - "phase": "", - "drugs": "['Home Hypnotherapy', 'Educational']", - "drugs_list": [ - "Home Hypnotherapy", - "Educational" - ], - "diseases": "['Functional Chest Pain']", - "diseases_list": [ - "Functional Chest Pain" - ], - "enrollment": "8.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 to 80, male or female. \n\n Patients must fulfill the Rome III criteria for Functional Chest Pain of Presumed Esophageal Origin for the previous 3 months (with symptom onset at least 6 months before diagnosis), including all of the following: \n\n Midline chest pain or discomfort that is not of burning quality \n\n Absence of evidence that gastroesophageal reflux is the cause of the symptom \n\n Absence of histopathology-based esophageal motility disorders \n\n Persistent symptoms despite a trial of antidepressant therapy, as defined by either: \n\n chest pain despite at least a continuous 4-week trial of at least one antidepressant within the last 6 months; or \n\n intolerance of at least one antidepressant within the last 6 months. \n\n Negative cardiac evaluation (negative cardiac stress test or negative coronary angiogram) \n\n Negative gastrointestinal evaluation for cause of the pain, defined by absence of Los Angeles grade C or D erosive esophagitis on endoscopy, persistent chest pain on PPI therapy, and no association of chest pain with reflux episodes on an ambulatory pH or pH-impedance study, defined as a symptom index <50% or symptom association probability <95% for chest pain . \n\n ", - "exclusion_criteria": ": \n\n Severe co-morbid illness (cardiac, pulmonary, renal, hematologic, hepatic) \n\n Prior treatment with hypnosis/hypnotherapy for a medical condition \n\n Prior major thoracic surgery \n\n Prior diagnosis of or treatment for dissociative disorders, post-traumatic stress disorder, borderline personality disorder, or other psychiatric disorders that include psychotic features \n\n Pregnancy or planned pregnancy within the upcoming 3 months \n\n Inability or unwillingness to give informed consent", - "brief_summary": "The primary aim is to develop and test the feasibility of a standardized digital audio home-hypnotherapy (HHT) program for patients with refractory functional chest pain (FCP).~The secondary aims of this study are:~To obtain pilot data to assess the magnitude of the treatment effect of self-hypnosis in refractory FCP for an anticipated future, larger treatment trial;~To determine the stability of the treatment effect of HHT in refractory FCP;~To assess the relationship between response to HHT and psychological factors; and~To assess the relationship between response to HHT and symptomatic dimensions of chest pain (severity, frequency, and duration).~To assess the difference", - "NCTID": "NCT01284179" - }, - { - "brief_title": "Management of Acute Myocardial Infarction in the Presence of Left Bundle Branch Block", - "phase": "", - "drugs": "['PCI']", - "drugs_list": [ - "PCI" - ], - "diseases": "['Acute Coronary Syndrome']", - "diseases_list": [ - "Acute Coronary Syndrome" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 - 75 years \n\n Ischemic discomfort (ie, ischemic chest pain or equivalent) at rest \u226520 minutes within previous 24 hours. \n\n Any (new, presumably new, or old) LBBB on the prehospital (ambulance) or admission ECG. \n\n Urgent coronary angiography (followed, when indicated, by PCI), ideally within 90 minutes after admission \n\n ", - "exclusion_criteria": ": \n\n all-comers design", - "brief_summary": "The primary objective of this study is to propose new treatment algorithm (strategy) for patients with Acute Coronary Syndrome (ACS) and left bundle-branch block (LBBB).", - "NCTID": "NCT01494870" - }, - { - "brief_title": "Search a Correlation Between Lp(a) Rate and TFPI Activity in Obese Patients With Chest Pain Like Angina", - "phase": "", - "drugs": "['blood sample']", - "drugs_list": [ - "blood sample" - ], - "diseases": "['Atherosclerosis']", - "diseases_list": [ - "Atherosclerosis" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Major \n\n Men \n\n Obese BMI>30 \n\n No aspirin treatment before inclusion \n\n Coronary exploration: coronary angiography or tomography coronary angiography \n\n Chest pain like stable angina \n\n ", - "exclusion_criteria": ": \n\n Women \n\n Severe hepatic insufficiency \n\n Inflammatory disease \n\n Neoplasia \n\n Protein S deficiency \n\n Aspirin treatment 10 days before inclusion \n\n Oral anticoagulant treatment at inclusion \n\n Heparin or low molecular weight heparin treatment at inclusion", - "brief_summary": "Atherosclerotic cardiovascular disease is a leading cause of mortality in our countries. Clinically, symptoms could be chest pain suggesting stable angina. Atherosclerosis is influenced by cardiovascular risk factors which obesity (Body Mass Index>30). Obesity is associated with an increase risk of cardiovascular complications.~Lipoprotein(a) is regarded as an independent risk factor for premature cardiovascular disease. Lp(a) is composed of low-density lipoprotein - like particle bound to glycoprotein molecule: apolipoprotein(a). Plasma levels are determinated to more than 90% by genetic factors (no significant influence of statin, weight, lifestyle factor: diet, exercise). Two study with few patients have found that aspirin lowers serum Lp(a) levels. Elevated Lp(a) is a risk factor for recurrent coronary events in obese patient.~Atherosclerosis is associated with imbalance of coagulation. TFPI (tissue factor pathway inhibitor) is the earliest inhibitor of the blood coagulation process, natural direct inhibitor of tissue factor. In-vitro, TFPI activity is inhibited by high Lp(a) .~The aim of this study is to research reverse association between Lp(a) and TFPI activity in obese patient with chest pain like stable angina suggesting atherosclerotic heart disease and effect of aspirin.", - "NCTID": "NCT01290770" - }, - { - "brief_title": "Intravenous Isosorbide Dinitrate Versus Sublingual Isosorbide Dinitrate for the Relief of Acute Anginal Episodes in Acute Coronary Syndrome (ACS) Patients", - "phase": "Phase 4", - "drugs": "['iso sorbide dinitrate iv bolus or s/l']", - "drugs_list": [ - "iso sorbide dinitrate iv bolus or s/l" - ], - "diseases": "['Unstable Angina', 'Myocardial Infarction']", - "diseases_list": [ - "Unstable Angina", - "Myocardial Infarction" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 18 years or older. \n\n Admission to the ICCU with ACS (non-ST elevation acute coronary syndrome or 24 hours after ST elevation myocardial infarction) . \n\n Presence of ischemic symptoms (\u22655 minutes) during hospitalization. \n\n Pain assessment of 3 out of 10 on Visual Analog Scale (VAS) 1 or dynamic ECG findings (ST segment deviation \u22650.05 mV or T wave inversion \u2265 0.3 mV) \n\n Willing and able to provide written informed consent according to the regulations of the Ministry of Health and the Helsinki committee instructions. \n\n - \n\n ", - "exclusion_criteria": ": \n\n Patient who meet any of the following criteria are excluded from the study: \n\n Persistent ST-segment elevation \u2265 1 mV in 2 or more contiguous leads or new LBBB. \n\n Acute pulmonary edema \n\n Sepsis \n\n Sustained systolic blood pressure < 90 mm Hg or evidence of cardiogenic shock \n\n Pregnant women \n\n Use at randomization of agents known to enhance the efficacy of nitrates. \n\n Clinically significant aortic stenosis \n\n Cr > 2 mg/dL \n\n Participation in another trial of an investigational drug or device on randomization. \n\n Allergy or sensitivity to nitatrate compounds \n\n Acute episode of cerebrovascular attack \n\n Inability to comply with the protocol and follow-up \n\n -", - "brief_summary": "This is a randomized, double blind, placebo-controlled study, clinical trail designed to evaluate the efficacy safety and superiority of intravenous boluses of isosorbide dinitrate for the relief of acute anginal pain episodes in acute coronary syndrome patients in comparison with the usual manner of S/L isosorbide dinitrate .", - "NCTID": "NCT00337116" - }, - { - "brief_title": "Hypertension Prevention Trial (HPT) Feasibility Study", - "phase": "Phase 2", - "drugs": "['diet, sodium-restricted', 'diet, reducing', 'potassium']", - "drugs_list": [ - "diet", - "sodium-restricted", - "diet", - "reducing", - "potassium" - ], - "diseases": "['Cardiovascular Diseases', 'Heart Diseases', 'Hypertension', 'Obesity', 'Vascular Diseases']", - "diseases_list": [ - "Cardiovascular Diseases", - "Heart Diseases", - "Hypertension", - "Obesity", - "Vascular Diseases" - ], - "enrollment": "", - "inclusion_criteria": "Men and women, ages 25 to 49. Diastolic blood pressure between 78 and 89 mm Hg. Free of major disease. Not on a special diet or antihypertensive medication at entry. Some mild to moderately obese subjects.", - "exclusion_criteria": "", - "brief_summary": "To test the feasibility and the efficacy of nutritional interventions in the primary prevention of hypertension in individuals predisposed to the development of hypertension; specifically, to test the hypothesis that reduction of weight and/or decreased sodium intake in obese individuals, or decreased sodium intake with or without increased potassium intake (in men and women, regardless of weight) would prevent the elevation of blood pressure and the incidence of hypertension.", - "NCTID": "NCT00000501" - }, - { - "brief_title": "Causal Inference Research of Resistant Hypertension Treatment With Chinese Approach in a Cohort Study", - "phase": "Phase 1", - "drugs": "['Herbs', 'Antihypertensive drugs']", - "drugs_list": [ - "Herbs", - "Antihypertensive drugs" - ], - "diseases": "['Primary Hypertension', 'Hypertension, Resistant to Conventional Therapy']", - "diseases_list": [ - "Primary Hypertension", - "Hypertension", - "Resistant to Conventional Therapy" - ], - "enrollment": "192.0", - "inclusion_criteria": "inclusion criteria: \n\n Essential hypertension subjects, aged 18-70 years, blood pressure > 140/90 mm Hg even used to be on 3 or more medications for a month and diagnosed as Phlegm and Stasis Syndrome will be included. \n\n ", - "exclusion_criteria": ": \n\n Patients will be excluded for the following conditions: with secondary resistant hypertension because of other disease like renal disease or pheochromocytoma; included in other clinical trial in one month; pregnant or breast-feed or preparing for pregnancy female; combined with disease like stroke, coronary atherosclerotic heart disease, diabetes, chronic renal failure or mental disease.", - "brief_summary": "The research of clinical effectiveness assessment is to explore the causal relationship between treatment and outcome.Accordingly, based on the effectiveness of tan-yu treatment, the research takes the Resistant Hypertension (RH) as example to study the causal inference methods under real world.", - "NCTID": "NCT01904695" - }, - { - "brief_title": "Efficacy and Safety of Ivabradine on Top of Atenolol in Stable Angina Pectoris", - "phase": "Phase 3", - "drugs": "['Ivabradine']", - "drugs_list": [ - "Ivabradine" - ], - "diseases": "['Angina Pectoris']", - "diseases_list": [ - "Angina Pectoris" - ], - "enrollment": "750.0", - "inclusion_criteria": "inclusion criteria: \n\n Chronic stable angina pectoris \n\n Documented coronary artery disease \n\n Previous treatment with atenolol or other beta-blocker agent \n\n Exercise tolerance test positivity and stability \n\n ", - "exclusion_criteria": ": \n\n Heart rate < 60 bpm \n\n Congestive heart failure", - "brief_summary": "To test whether ivabradine when given in combination with atenolol is able to improve the exercise tolerance of patients with stable angina pectoris", - "NCTID": "NCT00202566" - }, - { - "brief_title": "A Study on the Effects of Ranolazine on Exercise Duration in Subjects With Chronic Stable Angina and Coronary Artery Disease (CAD) With Type 2 Diabetes Mellitus (T2DM)", - "phase": "Phase 4", - "drugs": "['Ranolazine']", - "drugs_list": [ - "Ranolazine" - ], - "diseases": "['Type 2 Diabetes Mellitus', 'Angina Pectoris', 'Coronary Artery Disease']", - "diseases_list": [ - "Type 2 Diabetes Mellitus", - "Angina Pectoris", - "Coronary Artery Disease" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Written informed consent \n\n Males and females aged 18 to 79 years \n\n Able to perform a Sheffield Modified Bruce Treadmill Exercise Protocol \n\n At least a 3-months history of chronic stable angina triggered by physical effort and relieved by rest and/or sublingual nitroglycerin \n\n Coronary artery disease documented by one or more of the following: \n\n Angiographic evidence of \u2265 50% stenosis of one or more major coronary arteries \n\n History of myocardial infarction (MI) documented by positive CK-MB enzymes, troponins, or ECG changes \n\n Cardiac nuclear scan studies diagnostic of CAD, e.g., thallium scan or ECHO with stress or pharmacologic interventions (adenosine, dipyridamole, etc.) \n\n Stable treatment with one of the following antianginal medications for at least 4 weeks prior to Screening: \n\n beta-blocker (atenolol up to 50 mg daily or metoprolol up to 100 mg daily) \n\n dihydropyridine calcium-channel blocker (amlodipine up to 5 mg daily or nifedipine up to 30 mg daily) \n\n non-dihydropyridine calcium-channel blocker (diltiazem 180 to 360 mg daily or verapamil 180 to 360 mg daily) \n\n Willingness to discontinue other antianginals and be treated with one of the allowed antianginal therapies \n\n Documented history of type 2 diabetes mellitus \n\n Females of childbearing potential must agree to utilize highly effective contraception methods from Screening throughout the duration of study treatment and for 14 days following the last dose of study drug. \n\n ", - "exclusion_criteria": ": \n\n Inability to exercise or having exercise limitation due to other co-morbidities that may interfere with ability to perform required ETT (e.g., morbid obesity, significant chronic lung disease, prior hospitalization for acute exacerbation of chronic lung disease or home oxygen use, chronic oral steroid therapy that can limit exercise capacity, osteoarthritis, peripheral artery disease, etc.) \n\n Any absolute contraindication to ETT \n\n Presence of electrocardiographic or other abnormalities that interfere with ECG interpretation or may cause a false positive stress test (e.g., \u2265 1 mm horizontal or down-sloping ST segment depression at rest in any standard ECG lead, Lown-Ganong-Levine syndrome, Wolff-Parkinson-White syndrome, left bundle branch block, left ventricular hypertrophy with repolarization abnormality, ventricular pacemaker, etc.) \n\n Decompensated heart failure \n\n Clinically significant valvular heart disease or congenital cardiac defects \n\n Acute coronary syndrome in the prior 2 months or coronary revascularization within the prior 6 months or planned coronary revascularization during the study period \n\n Stroke or transient ischemic attack within 6 months prior to Screening \n\n History of serious ventricular dysrhythmias or a history of life-threatening ventricular arrhythmia \n\n Atrial fibrillation \n\n QTc > 0.5 seconds \n\n Hypertrophic cardiomyopathy \n\n Uncontrolled hypertension (seated systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg) \n\n Systolic blood pressure < 90 mm Hg \n\n Inability to discontinue current antianginal medications and remain on one allowed antianginal therapy \n\n Clinically significant hepatic impairment \n\n Creatinine clearance (CLCr) < 30 ml/min \n\n Prior treatment with ranolazine \n\n Participation in another investigational drug or device study within 1 month prior to Screening \n\n Females who are breastfeeding \n\n Positive serum pregnancy test \n\n Current treatment with potent inhibitors of CYP3A (e.g., ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir) \n\n Current treatment with CYP3A and P glycoprotein (Pgp) inducers (e.g., rifampicin/rifampin, carbamazepine, St. John's wort) \n\n History of illicit drug use or alcohol abuse within one year of screening \n\n Any other conditions that, in the opinion of the investigator, are likely to prevent compliance with the study protocol or pose a safety concern if the subject participates in the study", - "brief_summary": "This study will evaluate the efficacy of ranolazine compared to placebo on duration of exercise assessed by exercise tolerance testing (ETT) at anticipated peak ranolazine plasma concentration after 12 weeks of treatment in subjects with chronic stable angina and coronary artery disease (CAD) who have a history of type 2 diabetes mellitus (T2DM).", - "NCTID": "NCT01334203" - }, - { - "brief_title": "Efficacy and Safety of Lacidipine in Chronic Stable Angina", - "phase": "Phase 2", - "drugs": "['Lacidipine, low dose', 'Lacidipine, medium dose', 'Lacidipine, high dose', 'Placebo']", - "drugs_list": [ - "Lacidipine", - "low dose", - "Lacidipine", - "medium dose", - "Lacidipine", - "high dose", - "Placebo" - ], - "diseases": "['Angina Pectoris']", - "diseases_list": [ - "Angina Pectoris" - ], - "enrollment": "283.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 to 80 years \n\n History of stable, exertional angina pectoris (Canadian Cardiovascular Society functional class II to III) for at least 3 months duration prior to enrolment in the study \n\n Patients not currently receiving treatment with antianginal medication (other than short-acting nitrates) \n\n Between visits 2 and 3 two treadmill exercise tests, demonstrating \u2265 0.1 mV of horizontal or down sloping ST-segment depression, must be carried out. The difference in symptom-limited exercise duration between these two tests must not exceed 20% \n\n Total treadmill exercise duration > 3 minutes (i.e. stage 2 or above on a standard Bruce protocol) \n\n Coronary artery disease, preferably (not mandatory) documented by a history of proven myocardial infarction and/or coronary angiography indicating \u2265 50% reduction in luminal diameter of one or more coronary arteries or their primary branches \n\n ", - "exclusion_criteria": ": \n\n Myocardial infarction within 3 months prior to enrolment in the study \n\n Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass surgery within 6 months \n\n Other types of angina (variant, unstable) \n\n Uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg) \n\n Resting heart rate < 50 bpm or > 100 bpm \n\n Significant valvular heart disease \n\n Heart failure New York Heart Association Class III or IV \n\n Chronic obstructive pulmonary disease and/or asthma with clinical symptoms requiring regular medication \n\n Significant arrhythmia (since this may interfere with the interpretation of the electrocardiogram) including Wolff Parkinson-White syndrome, atrial fibrillation, atrial flutter, sick sinus syndrome, significant Atrio-Ventricular heart block, intraventricular conduction defect (QRS > 0.12 seconds) ventricular pre-excitation, bundle branch block, the presence of a pace-maker, the presence of an implanted automatic defibrillator, uncorrected hypokalaemia (potassium < 3.5 mmol/litre) \n\n Insulin dependent diabetes mellitus \n\n Significant liver disease (Aspartate Aminotransferase or Alanine Aminotransferase > twice the upper limit of reference range) \n\n Significant renal disease (creatinine > 1.5 x upper limit of reference range) \n\n Any clinical condition which in the opinion of the investigator, would preclude the safe fulfilment of the protocol and the safe administration of trial medication \n\n Inability to perform repeated exercise testing due to extra-cardiac reasons \n\n Concomitant treatment with any other anti-anginal medication, whether or not prescribed for this indication (e.g. calcium channel blockers, \u03b2-blockers or long-acting nitrates) \n\n Concomitant treatment with anti-arrhythmic medication, digitalis or tricyclic anti-depressants or other agents known to affect ST-segment morphology \n\n Known hypersensitivity to any of the components of the investigational drug \n\n Pregnant or nursing women or women of child bearing potential \n\n Participation in any other clinical trial within 2 months of enrolment \n\n History of drug or alcohol abuse", - "brief_summary": "The aim of this study was to explore whether lacidipine at doses of 2 mg, 4 mg and 6 mg decreased the symptoms of angina, compared to placebo in patients with chronic stable angina", - "NCTID": "NCT02232607" - }, - { - "brief_title": "Resistant Hypertension in Patients With Type-II-Diabetes Mellitus", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Resistant Hypertension', 'NIDDM']", - "diseases_list": [ - "Resistant Hypertension", - "NIDDM" - ], - "enrollment": "180.0", - "inclusion_criteria": "inclusion criteria: \n\n 18-80 years, informed consent, hypertension, type-II-diabetes mellitus \n\n ", - "exclusion_criteria": ": \n\n Non-compliance, s-creatinin above 200, AFli", - "brief_summary": "The risk of cardiovascular disease (CVD) in patients with type-II-diabetes mellitus (type-II-DM)is more than doubled and CVD accounts for 70% of deaths in this group of patients.~Hypertension is a major risk factor for CVD in patients with type-II-DM and a major contributor cardiovascular mortality. Uncontrolled- (UH) and resistant hypertension (RH)are more common in patients with type-II-DM, why further bloodpressure (BP) control is needed.~The prevalence of UH and RH has not been examined in a consecutive Danish outpatient population with type-II-DM.~The purpose of this study is to examine the prevalence of resistant hypertension in patients with type-II-diabetes and to examine the characteristics of patients with resistant hypertension as compared to patients with controlled hypertension with regards to arterial stiffness.", - "NCTID": "NCT01056367" - }, - { - "brief_title": "Phase II Study of STA-2 in Patients With Chronic Stable Angina", - "phase": "Phase 2", - "drugs": "['STA-2', 'Placebo']", - "drugs_list": [ - "STA-2", - "Placebo" - ], - "diseases": "['Chronic Stable Angina']", - "diseases_list": [ - "Chronic Stable Angina" - ], - "enrollment": "79.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female aged > 20; \n\n Patients who had effort-induced angina which was relieved by rest or nitroglycerin, or who had catheterization-documented coronary artery disease or previous myocardial infarction \u2265 3 months before screening; \n\n Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression \u2265 1 mm compared with at rest, with or without limiting angina) at screening (Day -7); \n\n Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression \u2265 1 mm compared with at rest, with or without limiting angina) on the day of enrollment (Day 0). ETT performance between Day -7 and Day 0 were required not differ by >20% in total exercise time; \n\n Female patient who was in the post-menopausal stage or of childbearing potential who: \n\n used adequate contraception since last menstruation and no plan for conception during the study; \n\n was non-lactating; \n\n had negative pregnancy test (urine) within 14 days prior to the study; \n\n Able to provide written informed consent. \n\n ", - "exclusion_criteria": ": \n\n Patients with pre-excitation, conduction abnormalities, pacemaker rhythm, unstable angina or myocardial infarction within the preceding 3 months; \n\n Patients with heart failure (New York Heart Association class III or IV), uncorrected valvular or congenital heart disease, patients who needed digoxin, isosorbide mononitrate, nitroglycerin sustained release preparation, theophylline, class I antiarrhythmic agents, digitalis, or monoamine oxidase inhibitors, as judged by the investigator; \n\n Patients with any EKG abnormalities preventing the interpretation of ischemia (complete left bundle branch block); \n\n Patients with Chronic Obstructive Pulmonary Disease (COPD) requiring bronchodilators; \n\n Patients with hepatic failure (defined as aspartate transaminase (AST) and/or alanine transaminase (ALT) > 3X the upper limit of normal values), and/or renal failure (defined as serum creatinine > 3 mg/dL); \n\n Patients with severe gastrointestinal illness as judged by the investigator; \n\n Patient with any conditions that interfered the performance of exercise tolerance test as judged by investigator (e.g., knee/ankle arthropathy, Parkinsonism, stroke).", - "brief_summary": "The objectives of this study are to evaluate the efficacy, pharmacological activities and safety of STA-2 in the treatment of chronic stable angina.", - "NCTID": "NCT01484912" - }, - { - "brief_title": "Osteopathic Treatment in Adult Patients With Cystic Fibrosis", - "phase": "Phase 3", - "drugs": "['Osteopathic treatment', 'Sham Placebo', 'Usual care']", - "drugs_list": [ - "Osteopathic treatment", - "Sham Placebo", - "Usual care" - ], - "diseases": "['Cystic Fibrosis', 'Back Pain', 'Neck Pain', 'Chest Pain']", - "diseases_list": [ - "Cystic Fibrosis", - "Back Pain", - "Neck Pain", - "Chest Pain" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria : \n\n Diagnosis of cystic fibrosis ( positive sweat test and / or presence of 2 disease causing mutations in the CFTR gene \n\n Age > 18 years \n\n Patient with chronic chest , neck or back pain \n\n Written Informed Consent \n\n with health insurance \n\n ", - "exclusion_criteria": " : \n\n regular follow-up by an osteopathic physician in the previous 3 months \n\n patients awaiting lung transplantation \n\n history of lung transplantation \n\n pregnancy \n\n understanding disorders preventing the patient to apply the study \n\n participation in another clinical interventional study protocol", - "brief_summary": "To study the contribution of osteopathy on the reduction of pain in adult patients with cystic fibrosis", - "NCTID": "NCT01293019" - }, - { - "brief_title": "Examining Genetic Influence on Response to Beta-Blocker Medications in People With Type 2 Diabetes", - "phase": "Phase 4", - "drugs": "['Atenolol']", - "drugs_list": [ - "Atenolol" - ], - "diseases": "['Diabetes Mellitus, Type 2']", - "diseases_list": [ - "Diabetes Mellitus", - "Type 2" - ], - "enrollment": "31.0", - "inclusion_criteria": "inclusion criteria: \n\n Type 2 diabetes \n\n Pre-Diabetes \n\n ", - "exclusion_criteria": ": \n\n Insulin therapy \n\n Treatment with any beta-blocker in the 30 days before study entry \n\n Asthma \n\n Chronic obstructive pulmonary disease (COPD) \n\n Greater than first degree heart block \n\n Heart rate less than 60 bpm \n\n Systolic blood pressure less than 90 mm Hg \n\n Raynaud's phenomenon \n\n Known history of angina, heart attack, heart failure, coronary revascularization, or automatic implantable cardioverter defibrillators \n\n Pregnant \n\n Creatinine clearance less than 35 ml/min \n\n Hematologic dysfunction (white blood cell [WBC] count less than 3000 or hematocrit less than 28%) \n\n Allergy to amide anesthetics", - "brief_summary": "Beta-blockers are medications used to treat cardiovascular disease (CVD) symptoms, including high blood pressure and chest pain. People with diabetes who receive beta-blockers may experience adverse health effects, but the exact cause of why this happens remains unknown. This study will examine the genetic factors that may influence how atenolol, a beta-blocker medication, affects fat breakdown, blood sugar levels, and heart function in people with type 2 diabetes.", - "NCTID": "NCT00925119" - }, - { - "brief_title": "Preventing Acute Chest Syndrome by Transfusion Feasibility Study", - "phase": "", - "drugs": "['Single blood transfusion', 'Standard care']", - "drugs_list": [ - "Single blood transfusion", - "Standard care" - ], - "diseases": "['Sickle Cell Disease']", - "diseases_list": [ - "Sickle Cell Disease" - ], - "enrollment": "237.0", - "inclusion_criteria": "inclusion criteria for the Observational and Trial Cohorts: \n\n Hemoglobin diagnosis of SS (two copies of the hemoglobin S gene), SC (one copy of the hemoglobin S gene and one copy of the hemoglobin C gene), or S-\u03b2 thalassemia (\u03b2+ or \u03b20) \n\n No clinically apparent ACS \n\n No prior participation in either part of the study \n\n inclusion criteria for the Trial Cohort, in addition to the above criteria: \n\n sPLA2 level greater than 100 ng/mL within the same 24-hour window that coincides with fever and chest radiograph negative for new pulmonary infiltrate within the last 12 hours of the 24-hour window \n\n Fever greater than 38.0\u00ba C within the same 24-hour window that coincides with elevated sPLA2 level (greater than 100 ng/mL) and chest radiograph negative for new pulmonary infiltrate within the last 12 hours of the 24-hour window \n\n Chest radiograph negative for new pulmonary infiltrate within the last 12 hours of the 24-hour window of an abnormal sPLA2 level and fever \n\n Hemoglobin levels equal or less than 10 g/dL at time of study entry \n\n Informed consent of parent(s) or legal guardian; informed consent or assent of participant as applicable \n\n ", - "exclusion_criteria": " for Observational and Trial Cohorts: \n\n Existing diagnosis of a new pulmonary infiltrate diagnosed by chest radiography (pleural effusion not obscuring lung parenchyma will not exclude the person from the study) \n\n Any coexisting medical condition for which the physician feels that a transfusion may be needed within 24 hours (e.g., severe anemia, stroke) \n\n Red Blood Cell (RBC) transfusion in the 60 days before study entry \n\n Unwillingness to sign consent form, or if a minor, unwillingness of parent/guardian to sign consent form \n\n Treatment with any investigational drug or device in the 30 days before study entry (hydroxyurea is allowable) \n\n History of alloimmunization that would prevent the participant from receiving blood within 8 hours of eligibility for study entry or history of a life-threatening transfusion reaction \n\n Objection to transfusion for religious or other reasons from either the participant or guardian \n\n History of treatment with systemic steroids within 1 week of study entry (inhaled steroids are acceptable) \n\n Pregnant", - "brief_summary": "Acute chest syndrome (ACS) is similar to severe pneumonia and is a common cause of hospitalizations for people with sickle cell disease (SCD). Blood transfusions are one treatment option for ACS. High levels of an enzyme called secretory phospholipase A2 (sPLA2) may be present in people before they develop ACS. This study will determine how well sPLA2 levels can predict the onset of ACS and whether identifying high sPLA2 levels allows enough time to prevent ACS with blood transfusions. Results from this study will help to determine the feasibility of conducting a larger study that would further examine the use of sPLA2 levels and blood transfusions to prevent ACS in people with SCD.", - "NCTID": "NCT00951808" - }, - { - "brief_title": "Gene Mutations in Secondary Pulmonary Hypertension", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Thromboembolic Pulmonary Hypertension']", - "diseases_list": [ - "Chronic Thromboembolic Pulmonary Hypertension" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of CTEPH and patient consent \n\n ", - "exclusion_criteria": ": \n\n No patient consent", - "brief_summary": "As a pulmonary hypertension center, we have created a database that prospectively tracks patients with different forms of secondary pulmonary hypertension. Records include genetic analysis, and clinical and hemodynamic profiles.", - "NCTID": "NCT00348803" - }, - { - "brief_title": "The First Therapeutic Intervention in Malignant Pleural Effusion Trial", - "phase": "", - "drugs": "['Large bore chest drain + NSAID based analgesic regimen', 'Small bore chest drain + NSAID based analgesic regimen', 'Large bore chest drain + opiate based analgesic regimen', 'Small bore chest drain + opiate based analgesic regimen']", - "drugs_list": [ - "Large bore chest drain + NSAID based analgesic regimen", - "Small bore chest drain + NSAID based analgesic regimen", - "Large bore chest drain + opiate based analgesic regimen", - "Small bore chest drain + opiate based analgesic regimen" - ], - "diseases": "['Malignant Pleural Effusion', 'Pleural Effusion']", - "diseases_list": [ - "Malignant Pleural Effusion", - "Pleural Effusion" - ], - "enrollment": "4.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis. The diagnosis may be established by one of: \n\n Histologically proven pleural malignancy OR \n\n Typical features of pleural malignancy seen on direct vision during thoracoscopy OR \n\n Pleural effusion in the context of histologically proven cancer elsewhere \n\n Expected survival more than 1 month \n\n Written informed consent \n\n ", - "exclusion_criteria": ": \n\n Age < 18 years \n\n Primary lymphoma or small cell lung carcinoma \n\n Patients who are pregnant or lactating \n\n Inability to give informed consent \n\n History of GI bleeding or of untreated peptic ulceration \n\n Known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs)/opiates/acetaminophen \n\n Hypercapnic respiratory failure \n\n Known intravenous drug abuse \n\n Severe renal or liver disease \n\n Known bleeding diathesis \n\n Warfarin therapy \n\n Current or recent (within 2 weeks) corticosteroid steroid therapy", - "brief_summary": "Fluid caused by cancer cells may accumulate in the lining of the lung. Draining the fluid with a chest tube may relieve pain and shortness of breath. To stop the fluid from coming back again, patients are given a medicine (talc) into the chest drain to seal up the space around the lung. This procedure is known as pleurodesis. This sometimes causes pain and discomfort, and the investigators do not know the best way of preventing this.~The investigators hope to find the best way to prevent pain during pleurodesis.", - "NCTID": "NCT00896285" - }, - { - "brief_title": "Surveillance of Efficacy and Safety of Drug PRITOR in patieNts With Arterial Hypertension, Who do Not Tolerate ACE inhibitoR Treatment", - "phase": "", - "drugs": "['Kinzal/Pritor (Telmisartan, BAY68-9291)']", - "drugs_list": [ - "Kinzal/Pritor (Telmisartan", - "BAY68-9291)" - ], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "3114.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients over 18 years of age \n\n Arterial hypertension (SBP < 160 mmHg and DBP < 100 mmHg) \n\n Patients, who do not tolerate ACE inhibitors (must be documented in the official ambulant documentation) \n\n inclusion criteria for the control arm (treated by ACEi): \n\n Patients over 18 years of age \n\n Arterial hypertension (SBP < 160 mmHg and DBP < 100 mmHg) \n\n Patients, who tolerate ACEi treatment \n\n ", - "exclusion_criteria": ": \n\n Cholestasis, severe hepatic insufficiency \n\n Allergy to telmisartan \n\n Gravidity or lactation \n\n ", - "brief_summary": "Surveillance of efficacy and safety of drug PRITOR in patieNts with arterial hypertension, who do not tolerate ACE inhibitoR treatment", - "NCTID": "NCT00932867" - }, - { - "brief_title": "Effects of Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea (OSA)", - "phase": "", - "drugs": "['Olmesartan and Azelnidipine']", - "drugs_list": [ - "Olmesartan and Azelnidipine" - ], - "diseases": "['Obstructive Sleep Apnea', 'Hypertension']", - "diseases_list": [ - "Obstructive Sleep Apnea", - "Hypertension" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Apnea and hypopnea index of more than 20 /hr, and treated with CPAP \n\n Uncontrolled hypertension (defined as systolic blood pressure of more than 130 mmHg or diastolic blood pressure of more than 80 mmHg \n\n ", - "exclusion_criteria": ": \n\n Cerebrovascular diseases, myocardial infarction, angina pectoris or heart failure within 6 months \n\n Uncontrolled arrhythmia \n\n Severe hepatic or renal disorders \n\n Having poor prognosis disorders such as malignant disorders", - "brief_summary": "The aim of the present study is to compare the effects of different types of antihypertensive drugs (angiotensin II receptor blockers and long-acting calcium channel blockers) in patients with hypertension and obstructive sleep apnea who are not controlled well with their hypertension after continuous positive airway pressure therapy.", - "NCTID": "NCT01028534" - }, - { - "brief_title": "Treatment of High Blood Pressure Using Olmesartan With Hydrochlorothiazide Compared to an ACE Inhibitor With a Calcium Channel Blocker", - "phase": "Phase 4", - "drugs": "['Olmesartan medoxomil', 'Hydroclorothiazide', 'Benazepril', 'Amlodipine']", - "drugs_list": [ - "Olmesartan medoxomil", - "Hydroclorothiazide", - "Benazepril", - "Amlodipine" - ], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "152.0", - "inclusion_criteria": "inclusion criteria: \n\n Greater than 18 years of age \n\n Patients with high blood pressure \n\n ", - "exclusion_criteria": ": \n\n Hypertensive encephalopathy, stroke or transient ischemic attack within the past 6 months \n\n History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months \n\n Type 1 diabetes mellitus", - "brief_summary": "A comparison of 2 different combinations of high blood pressure medications to treat hypertension", - "NCTID": "NCT00185120" - }, - { - "brief_title": "The Effects of Inorganic Nitrate on Cardiac Muscle in Angina", - "phase": "Phase 2", - "drugs": "['Sodium Nitrate', 'Placebo']", - "drugs_list": [ - "Sodium Nitrate", - "Placebo" - ], - "diseases": "['Chronic Stable Angina']", - "diseases_list": [ - "Chronic Stable Angina" - ], - "enrollment": "70.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients aged 18 and over with chronic stable angina (\u22652 months duration). \n\n inclusion criteria Following screening visit: \n\n A positive exercise ECG (1mmSTD at J+0.08 seconds) on a modified Bruce protocol treadmill exercise test. \n\n A positive dobutamine stress echocardiogram, \n\n and/or a positive myocardial perfusion scan (MPI), \n\n and/or a positive coronary angiogram. \n\n ", - "exclusion_criteria": ": \n\n Unable to do exercise test \n\n Women of child bearing potential \n\n If of a racial origin at risk of glucose-6-phosphate dehydrogenase (G6PD) deficiency, G6PD will be excluded prior to inclusion in the study \n\n Resting STD>=1mm \n\n NYHA 3 or 4 HF or LVEF<45% \n\n Myocardial infarction or revascularisation within the last two months \n\n Left bundle branch block (LBBB)", - "brief_summary": "Previous studies have shown that interventions which modestly increase blood nitrite_ improve skeletal muscle function on exercise while sparing oxygen, and have been also shown to open up the blood flow during periods of oxygen deprivation. Inorganic nitrate in the diet is absorbed into the bloodstream, concentrated and reduced by bacteria in the mouth to nitrite, which is then absorbed into the bloodstream. .~The purpose of this study is to look at the effects of oral inorganic nitrate supplementation on clinical markers of heart ischaemia and the frequency of angina.", - "NCTID": "NCT02078921" - }, - { - "brief_title": "European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial", - "phase": "Phase 3", - "drugs": "['Bivalirudin', 'Heparin']", - "drugs_list": [ - "Bivalirudin", - "Heparin" - ], - "diseases": "['Acute Coronary Syndrome']", - "diseases_list": [ - "Acute Coronary Syndrome" - ], - "enrollment": "2198.0", - "inclusion_criteria": "inclusion criteria: \n\n The decision to randomize participants was made by a qualified physician or paramedic who was present at the time. \n\n Participants were included in the study if they presented either via ambulance or to a center where PCI was not performed and met all of the following criteria: \n\n Provided written informed consent before initiation of any study related procedures. Participants randomized in the ambulance may initially have signed an abridged version. \n\n Aged \u226518 years at the time of randomization. \n\n Had a presumed diagnosis of STE-ACS with onset of symptoms of >20 minutes and <12 hours with one or more of the following: \n\n ST segment elevation of \u22651 millimeters (mm) in \u22652 contiguous leads \n\n Presumably new left bundle branch block \n\n An infero-lateral myocardial infarction with ST segment depression of \u22651 mm in \u22652 of leads V1-3 with a positive terminal T wave \n\n All participants would proceed with emergent angiography and primary PCI if indicated <2 hours after first medical contact \n\n ", - "exclusion_criteria": ": \n\n Participants were excluded from the study if any of the following ", - "brief_summary": "To show that the early administration of bivalirudin improves 30 day outcomes when compared to the current standard of care in participants with ST segment elevation acute coronary syndrome (STE-ACS), intended for a primary percutaneous coronary intervention (PCI) management strategy, presenting either via ambulance or to centers where PCI is not performed.", - "NCTID": "NCT01087723" - }, - { - "brief_title": "Genetic Mapping for Cardiac Risk Assessment", - "phase": "", - "drugs": "['MULTIGENE SCREENING FOR SINGLE SNPS']", - "drugs_list": [ - "MULTIGENE SCREENING FOR SINGLE SNPS" - ], - "diseases": "['Angina Pectoris', 'Myocardial Infarction', 'Coronary Disease', 'Myocardial Ischemia', 'Acute Coronary Syndrome']", - "diseases_list": [ - "Angina Pectoris", - "Myocardial Infarction", - "Coronary Disease", - "Myocardial Ischemia", - "Acute Coronary Syndrome" - ], - "enrollment": "2000.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients affected by history of IHD with a non-fatal evolution(angina or AMI as first manifestation),age at the onset of the disease (<50 o >60 years. \n\n Patients with acute coronary syndrome as first manifestation of coronary disease, admitted to the coronary unit within 6 hours from the onset of symptoms. \n\n ", - "exclusion_criteria": ": \n\n Age>75 \n\n Pregnancy \n\n Recent(< 6 months) cerebral ischemic attack \n\n Active cancer \n\n Inability to provide an informed consent.", - "brief_summary": "The main objective of the GENOCOR project (Genetic mapping for cardiac risk assessment) is the setting up of a joint public/private laboratory (GENOCOR-LAB) dedicated to the development and testing of new cost-effective technologies exploiting the growing knowledge in the genomic correlates of cardiovascular diseases (CVD) and of their evolution; the data obtained by the GENOCOR-Lab should especially orient secondary prevention and specific treatment of ischemic heart diseases (IHD).", - "NCTID": "NCT01506999" - }, - { - "brief_title": "Ibuprofen or Morphine in Treating Pain in Patients Undergoing Pleurodesis for Malignant Pleural Effusion", - "phase": "Phase 2", - "drugs": "['ibuprofen', 'morphine sulfate', 'management of therapy complications', 'pleurodesis']", - "drugs_list": [ - "ibuprofen", - "morphine sulfate", - "management of therapy complications", - "pleurodesis" - ], - "diseases": "['Metastatic Cancer']", - "diseases_list": [ - "Metastatic Cancer" - ], - "enrollment": "320.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Diagnosis of malignant pleural effusion requiring pleurodesis confirmed by 1 of the following: \n\n Histologically proven pleural malignancy \n\n Typical features of pleural malignancy seen on direct vision during thoracoscopy \n\n Pleural effusion in the context of histologically proven cancer elsewhere \n\n No primary lymphoma or small cell lung carcinoma \n\n All patients undergoing thoracoscopy for suspected malignant pleural effusion are eligible \n\n PATIENT CHARACTERISTICS: \n\n Life expectancy > 1 month \n\n Not pregnant or nursing \n\n No history of GI bleeding or untreated peptic ulceration \n\n No known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), opiates, or paracetamol \n\n No hypercapnic respiratory failure \n\n No known intravenous drug abuse \n\n No severe renal or liver disease \n\n No known bleeding diathesis \n\n Able to give informed consent \n\n PRIOR CONCURRENT THERAPY: \n\n More than 2 weeks since prior and no concurrent corticosteroid therapy \n\n No concurrent warfarin therapy \n\n No other concurrent analgesics \n\n Analgesics used as a breakthrough regimen are allowed from trial entry to tube withdrawal at day 3 post-pleurodesis (i.e., regular paracetamol, assigned study analgesia, and breakthrough medication only, including opiate slow release patches) \n\n No concurrent enrollment on another clinical study \n\n Patients may participate in other trials immediately after completion of current trial, excluding those involving further pleural procedures or analgesia trials in which patients must wait at least 3 months after completion of current trial", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Morphine and ibuprofen help lessen pain caused by pleurodesis. It is not yet known whether one drug is more effective than the other in lessening pleurodesis-related pain or whether the size of the chest drain tube affects pain.~PURPOSE: This randomized clinical trial is studying ibuprofen to see how well it works compared with morphine in treating pain in patients undergoing pleurodesis for malignant pleural effusion.", - "NCTID": "NCT00644319" - }, - { - "brief_title": "Cerebral Blood Flow Changes in People With Obesity After Glucose Consumption", - "phase": "", - "drugs": "['75 grams of glucose plus water solution', 'Pure water']", - "drugs_list": [ - "75 grams of glucose plus water solution", - "Pure water" - ], - "diseases": "['Obesity']", - "diseases_list": [ - "Obesity" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Live in Ribeir\u00e3o Preto, S\u00e3o Paulo - Brazil. \n\n Age between 18 and 40 years old. \n\n Female gender. \n\n Regular menses. \n\n Weight inferior than 120 Kg and body mass index (BMI) between 30 and 40 kg/m2, for the group with obesity. \n\n BMI between 18,5 and 24,9 kg/m2, for the group without obesity. \n\n ", - "exclusion_criteria": ": \n\n High blood pressure, diabetes, glucose intolerance or impaired fasting glycemia, metabolic syndrome, hypothyroidism and any kidney, liver, heart or neurologic disease. \n\n Psychiatric disorders, alcoholism, smoking or illicit drug abuse. \n\n Pregnancy or desire to be pregnant \n\n Use of medications, excluding contraceptives. \n\n Contraindication for magnetic resonance imaging. \n\n Be in treatment for obesity.", - "brief_summary": "This study evaluates the hypothesis that a meal constituted of only glucose produces differences in the brain blood flow in people with obesity that are not observed in people without obesity. These changes, at least in part, could explain the mechanisms involved in maintenance or development of obesity.", - "NCTID": "NCT02072694" - }, - { - "brief_title": "Evaluating the Link Between Neighborhood Environments and Obesity Among African American Women", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Obesity']", - "diseases_list": [ - "Obesity" - ], - "enrollment": "23000.0", - "inclusion_criteria": "inclusion criteria: \n\n Participating in the BWHS study \n\n Residing in New York, Los Angeles, or Chicago", - "exclusion_criteria": "", - "brief_summary": "African American women have higher rates of obesity than women of any other racial or ethnic group in the United States. Obesity can have many causes, including genetic and environmental factors. This study will examine how neighborhood environments influence the occurrence of obesity among African American women.", - "NCTID": "NCT00356707" - }, - { - "brief_title": "Efficacy of Euminz\u00ae for Tension-Type Headache", - "phase": "Phase 4", - "drugs": "['Euminz\u00ae', 'Placebo']", - "drugs_list": [ - "Euminz\u00ae", - "Placebo" - ], - "diseases": "['Episodic Tension-Type Headache']", - "diseases_list": [ - "Episodic Tension-Type Headache" - ], - "enrollment": "211.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female patients from 18 years onwards \n\n History of ETTH for at least one year. The number of days with such a headache is \u22652 per month \n\n Onset of TTH below 65 years of age \n\n At least 10 previous headache attacks fulfilling the following four inclusion criteria: \n\n Patients with headache attacks lasting from 30 minutes to 7 days \n\n At least two of the following pain characteristics are present: \n\n - Pressing or tightening (non-pulsating) quality \n\n - Intensity of pain: moderate = unable to ignore (pain may inhibit, but does not prohibit activities) \n\n - Bilateral location \n\n - No aggravation by walking stairs or similar routine physical activity \n\n Headache is not accompanied by nausea or vomiting (anorexia may occur) \n\n Headache is not accompanied by a combination of the following symptoms: photophobia and phonophobia (only one may be present) \n\n 3 months retrospective history \n\n Willingness and ability to keep the patient's diary and to comply with the procedures of the study \n\n Written informed consent \n\n ", - "exclusion_criteria": ": \n\n Headaches other than TTH: (e.g. migraine, cluster headache, hypertension headache, drug-related headache,analgesic-induced headache,post-traumatic headache; associated migraine attacks are permitted if they are well recognized by the patient and if their frequency during the preceding year has not exceeded one per month) \n\n Presence of oromandibular dysfunction \n\n History of facial or cranial surgery \n\n Use of prophylactic drugs for headache within one month prior to enrolment \n\n Use of drugs for acute TTH treatment for \u2265 10 days of headache per month \n\n Anticipated problems in adhering to the self-observation procedure (e.g. because of work) \n\n Abuse of alcohol, narcotics or other drugs \n\n Serious illnesses within the last 3 months (e.g. myocardial infarction, cardiac insufficiency NYHA III and IV, low blood pressure, cerebral insult, diabetes mellitus, neuropathy, changes in the skin or neoplasms in the head) \n\n Epilepsy \n\n Intake of anti-psychotic, anti-depressant or anti-epileptic medication during the previous month \n\n Intake of long-acting non-steroidal anti-inflammatory drugs within the last month \n\n Planned start of new pharmacological or non-pharmacological therapies \n\n Any significant skin condition affecting face or neck \n\n Known hypersensitivity towards peppermint oil \n\n Previous use of Euminz\u00ae or any other essential oil solutions for headache in the last three months \n\n Participation in another clinical trial within the last month \n\n Accommodation in an institution at judicial or official request", - "brief_summary": "Efficacy and safety of Euminz\u00ae (10% ethanolic solution of peppermint oil for topical use) compared to placebo in patients with episodic tension-type headache (ETTH).~Prospective, double-blind, placebo-controlled, phase IV clinical trial; Parallel-groups design; Randomisation 1:1; First attack per patient will be evaluated for primary objectives, following attacks during study duration will be observed and documented.~Study duration per patient: 10 weeks", - "NCTID": "NCT01770080" - }, - { - "brief_title": "Ivabradine and Post-revascularisation Microcirculatory Dysfunction", - "phase": "Phase 4", - "drugs": "['Ivabradine']", - "drugs_list": [ - "Ivabradine" - ], - "diseases": "['Coronary Artery Disease', 'Angina']", - "diseases_list": [ - "Coronary Artery Disease", - "Angina" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Symptoms of Angina Pectoris \n\n Angiographic evidence of epicardial coronary artery stenosis referred for PCI \n\n Flow limiting lesion (Fractional Flow Reserve \u22640.80) in one of following locations (as defined in SYNTAX trial89): \n\n Proximal or mid left anterior descending artery (LAD) \n\n Proximal or mid dominant right coronary artery (RCA) \n\n Proximal left circumflex artery (LCx) or 1ST Obtuse marginal Vessel \n\n Existing beta blocker prescription \n\n Echocardiogram performed within preceding 12 months \n\n Patient consent \n\n ", - "exclusion_criteria": ": \n\n Previous myocardial infarction (MI) in target vessel myocardial territory or any MI in preceding 12 months (defined by patient history, ECG changes and evidence of regional wall motion abnormalities on echocardiography) \n\n FFR>0.80 in target vessel at time of procedure \n\n Requirement for Multi-vessel intervention in a single procedure \n\n Any chronic total occlusion (100% epicardial occlusion) on angiography \n\n Distal coronary artery stenosis or that affecting non-dominant RCA \n\n Heart Rate <60 bpm at inclusion (assessed by 12 lead ECG after minimum 10 minutes rest period) \n\n Any rhythm other than sinus rhythm \n\n Sick sinus syndrome or high grade atrio-ventricular block \n\n Permanent Pacemaker in situ \n\n Congenital QT Syndrome \n\n Intolerance or allergy to beta-blockers \n\n Intolerance to Ivabradine \n\n Additional (other than angina pectoris) indication for beta-blocker treatment e.g. ventricular tachycardia \n\n Concurrent required use of rate-limiting drugs other than beta-blockers \n\n The necessity of combination therapy with Ivabradine and bisoprolol to achieve heart rate control \n\n Contraindication to Magnetic Resonance Imaging or IV adenosine \n\n Severe impairment of renal function (eGFR<30ml/min) \n\n Severe Liver Disease (Any worse than Grade A by Child-Pugh Classification)", - "brief_summary": "The aim of the study is to test whether, in patients with angina and flow limiting epicardial coronary artery disease, pre-treatment with Ivabradine, as opposed to beta blockers, will reduce post percutaneous coronary intervention induced microvascular dysfunction.", - "NCTID": "NCT02507050" - }, - { - "brief_title": "Comparison of Intravenous Injection of Calcium Antagonist and Beta-blockade on Endothelial Shear Stress of Coronary Artery", - "phase": "Phase 4", - "drugs": "['Nicardipine , Esmolol']", - "drugs_list": [ - "Nicardipine ", - "Esmolol" - ], - "diseases": "['Acute Coronary Syndrome', 'Coronary Artery Disease']", - "diseases_list": [ - "Acute Coronary Syndrome", - "Coronary Artery Disease" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of unstable angina and non-Q wave myocardial infarction \n\n Age 18-75 yr. \n\n Diameter stenosis of coronary artery<70% diameter stenosis by visual estimation \n\n Blood pressure >110/70 mmHg \n\n Heart rate 60- \n\n 100 bpm, No cardiac arrhythmias \n\n ", - "exclusion_criteria": ": \n\n St-elevation myocardial infarction \n\n Lower blood pressure(<100/70mmHg) \n\n Heart rate <60 or >100 bpm, The presence of cardiac arrhythmias \n\n Allergy to study drugs \n\n Women in pregnancy \n\n Liver dysfunction \n\n Creatinine >2.5mg/dl \n\n Bleeding stroke within 6 months \n\n Left ventricular ejection fraction<30% before maximal medication", - "brief_summary": "Both calcium channel antagonist and beta-blocker have cardioprotective effect. Endothelial shear stress is predictive factor of clinical outcomes in patients with obstructive stenosis.~The present study aims at comparing the re-distribution of shear stress and blood velocity during whole cardiac cycle after trans-coronary injection of Nicardipine and esmolol.", - "NCTID": "NCT01171911" - }, - { - "brief_title": "Chest Wall Influence on Respiratory System Mechanics in Morbidly Obese Patients", - "phase": "", - "drugs": "['Respiratory mechanics assessment']", - "drugs_list": [ - "Respiratory mechanics assessment" - ], - "diseases": "['Obesity', 'Intra-Abdominal Hypertension']", - "diseases_list": [ - "Obesity", - "Intra-Abdominal Hypertension" - ], - "enrollment": "14.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years or older \n\n Requiring intubation and mechanical ventilation \n\n BMI\u226540 kg/m2 or IAP\u226512 mmHg \n\n ", - "exclusion_criteria": ": \n\n Known presence esophageal varices \n\n Recent esophageal trauma or surgery \n\n Severe thrombocytopenia (PTL\u226410,000/mm3) \n\n Severe coagulopathy (INR\u22652) \n\n Presence of pneumothorax \n\n Pregnancy \n\n Patients with diagnosed moderate to severe ARDS or with poor oxygenation index (PaO2/FiO2 < 200 mmHg)", - "brief_summary": "The goal of this study is to describe the influence of the chest wall on the respiratory system mechanics in morbidly obese patients and in patients with high intra-abdominal pressure.~The effects of increasing and decreasing positive end-expiratory pressure (PEEP) on chest wall and total respiratory system mechanics, lung volumes and gas exchange will be evaluated, both during controlled and assisted mechanical ventilation.~Patients will be studied, first, during the acute phase of respiratory failure, when requiring intubation and controlled mechanical ventilation. Then, patients will be evaluated again during weaning from the ventilator to assess the influence of PEEP in assisted ventilation prior to extubation.", - "NCTID": "NCT02105220" - }, - { - "brief_title": "Intrapleural Minocycline After Simple Aspiration for the Prevention of Primary Spontaneous Pneumothorax", - "phase": "Phase 3", - "drugs": "['Simple aspiration with minocycline pleurodesis', 'simple aspiration']", - "drugs_list": [ - "Simple aspiration with minocycline pleurodesis", - "simple aspiration" - ], - "diseases": "['Pneumothorax']", - "diseases_list": [ - "Pneumothorax" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female. \n\n Age between 15 and 40 years old. \n\n First episode of spontaneous pneumothorax. \n\n Symptomatic (dyspnea or chest pain) or the rim of air is > 2cm on CXR requiring simple aspiration \n\n Complete or nearly complete and persistent lung expansion immediately following manual aspiration \n\n Organ Function Requirements: \n\n Adequate hematological function (Hb > 10 g/dl, ANC > 1.5 x 109/L, platelets > 100 x 109/L) \n\n Normal renal and hepatic functions: serum creatinine < 1 x ULN, SGPT and SGOT< 2.5 x ULN, alkaline phosphatase < 5 x ULN \n\n Written inform consent \n\n ", - "exclusion_criteria": ": \n\n With underlying pulmonary disease (asthma, chronic obstructive pulmonary disease, bronchiectasis, etc) \n\n With hemothorax or tension pneumothorax requiring chest tube insertion or operation \n\n A history of previous pneumothorax \n\n A history of previous ipsilateral thoracic operation \n\n Allergy to tetracycline or minocycline \n\n Pregnant or lactating patients. \n\n Other serious concomitant illness or medical conditions: \n\n Congestive heart failure or unstable angina pectoris. \n\n History of myocardial infarction within 1 year prior to the study entry. \n\n Uncontrolled hypertension or arrhythmia. \n\n History of significant neurologic or psychiatric disorders, including dementia or seizure. \n\n Active infection requiring i.v. antibiotics.", - "brief_summary": "The estimated recurrence rate of primary spontaneous pneumothorax is 23-50% after the first episode, and the optimal treatment remains unknown. In the recently published British Thoracic Society (BTS) guidelines, simple aspiration is recommended as first line treatment for all primary pneumothoraces requiring intervention. However, the 1 year recurrence rate of this procedure was as high as 25-30%, making it inappropriate as a standard of care.~Intrapleural instillation of a chemical irritant (chemical pleurodesis) is an effective way to shorten the duration of air leaks and reduce the rates of recurrent spontaneous pneumothorax in surgical and non-surgical patients. Many chemical irritants (tetracycline, talc, and minocycline) have been used to decrease the rate of recurrence in spontaneous pneumothorax. Tetracycline, which was the most commonly used irritant, is no longer available. Talc insufflation of the pleural cavity is safe and effective for primary spontaneous pneumothorax. However, it should be applied either with surgical or medical thoracoscopy. Minocycline, a derivative of tetracycline, is as effective as tetracycline in inducing pleural fibrosis in rabbits. In the previous studies, we have shown that additional minocycline pleurodesis is a safe and convenient procedure to decrease the rates of ipsilateral recurrence after thoracoscopic treatment of primary spontaneous pneumothorax. In the present study, additional minocycline pleurodesis will be randomly administered in patients with first episode of primary spontaneous pneumothorax after simple aspiration to test if it can reduce the rate of recurrence.", - "NCTID": "NCT00418392" - }, - { - "brief_title": "Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension", - "phase": "Phase 2", - "drugs": "['ambrisentan']", - "drugs_list": [ - "ambrisentan" - ], - "diseases": "['Pulmonary Hypertension']", - "diseases_list": [ - "Pulmonary Hypertension" - ], - "enrollment": "54.0", - "inclusion_criteria": "inclusion criteria: \n\n Must have completed Visit 14/Week 24 of the NCT00046319 study. \n\n Women of childbearing potential must have a negative urine pregnancy test at the Screening/Enrollment Visit and agree to use a reliable double barrier method of contraception until study completion and for >=4 weeks following their final study visit. \n\n Must have completed the Down-titration Period of NCT00046319 prior to enrollment in AMB-220-E and will meet the following additional criteria: \n\n Subjects with a diagnosis of HIV must have stable disease status at the time of Screening/Enrollment. \n\n Must be stable on conventional therapy for PAH for >=4 weeks prior to the Screening Visit. \n\n ", - "exclusion_criteria": ": \n\n Chronic prostanoid therapy, or other investigational prostacyclin derivative within 4 weeks prior to the Screening Visit. \n\n Intravenous inotrope use within 2 weeks prior to the Screening Visit. \n\n Females who are pregnant or breastfeeding. \n\n Contraindication to treatment with an endothelin receptor antagonist (ERA).", - "brief_summary": "AMB-220-E is an international, multicenter, open-label study examining the long-term safety of ambrisentan (BSF 208075) in subjects who have previously completed Myogen study NCT00046319, A Phase II, Randomized, Double-Blind, Dose-Controlled, Dose-Ranging, Multicenter Study of BSF 208075 Evaluating Exercise Capacity in Subjects with Moderate to Severe Pulmonary Arterial Hypertension.", - "NCTID": "NCT00424021" - }, - { - "brief_title": "MetfoRmin and Its Effects on Left Ventricular Hypertrophy in Normotensive Patients With Coronary Artery Disease", - "phase": "Phase 4", - "drugs": "['Metformin XL', 'Placebo']", - "drugs_list": [ - "Metformin XL", - "Placebo" - ], - "diseases": "['Left Ventricular Hypertrophy', 'Insulin Resistance', 'Coronary Artery Disease', 'PreDiabetes']", - "diseases_list": [ - "Left Ventricular Hypertrophy", - "Insulin Resistance", - "Coronary Artery Disease", - "PreDiabetes" - ], - "enrollment": "68.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged 18 years or over \n\n Participant willing and able to give informed consent. \n\n Documented Ischaemic Heart Disease: either angio-graphically documented coronary artery disease or a previous history of myocardial infarction/angina. \n\n Screening echocardiography based diagnosis of LVH (LV mass indexed to height to the allometric power of 1.7; males > 81g/h1.7, females >60g/h1.7) \n\n Fasting insulin resistance index \u2265 2.7 AND/OR HbA1c >5.6 and less than 6.5 at screening \n\n Blood pressure < 140/85 mm Hg or 24hr BP <135/85 daytime average in screening \n\n Able (in the Investigators opinion) and willing to comply with all study requirements. \n\n ", - "exclusion_criteria": ": \n\n Cognitive impairment \n\n Type 1 or 2 Diabetes mellitus \n\n Chronic Heart Failure as evidenced by echocardiogram or documented diagnosis of CHF \n\n Left Ventricular Ejection Fraction <45% on screening echocardiography \n\n Contraindications to cardiac MRI (pacemakers, claustrophobia, metal implants, history of penetrative eye injury or exposure to metal fragments in eye requiring medical attention) \n\n Malignancy (receiving active treatment) or other life threatening disease, renal disease (CKD class 3B or worse) \n\n Pregnancy/lactating females \n\n Any other reason considered inappropriate by a study physician \n\n Participants who have participated in any other clinical trial within the previous 30 days.", - "brief_summary": "Thickening of the heart muscle (left ventricle) known medically as Left Ventricular Hypertrophy (LVH) is very common in patients with heart disease. This increases risk of cerebrovascular/cardiovascular event.~LVH is asymptomatic and managed by the use of medication to control blood pressure, however LVH may be seen in normotensive patients where factors such as obesity and insulin resistance are present.~Insulin resistance is a condition where although the body produces insulin it is unable to utilize it effectively. Metformin, a drug used to treat diabetes, can reduce insulin resistance and cause weight loss, it may therefore improve LVH. This study will investigate the ability of metformin to reduce LVH in patients with heart disease, this may be a novel way forward in the risk reduction of cerebrovascular/cardiovascular events. Participants will be identified throughout NHS Tayside, those eligible will be randomly allocated to either metformin or a dummy medication (placebo) and will receive one year of treatment. At the beginning of the study, the thickness of the heart muscle will be measured by ultrasound scan and cardiac Magnetic Resonance Imaging (cMRI). We will also perform non-invasive tests to measure blood vessel function. These tests will be repeated after one year. At the end of the study, we will investigate the difference between placebo treatment and metformin treatment.~This study is funded by the British Heart Foundation.", - "NCTID": "NCT02226510" - }, - { - "brief_title": "Characteristics of Prader-Willi Syndrome and Early-onset Morbid Obesity", - "phase": "", - "drugs": "['Group 1', 'Group 2']", - "drugs_list": [ - "Group 1", - "Group 2" - ], - "diseases": "['Prader-Willi Syndrome', 'Obesity']", - "diseases_list": [ - "Prader-Willi Syndrome", - "Obesity" - ], - "enrollment": "392.0", - "inclusion_criteria": "inclusion criteria: \n\n Individuals enrolling in the Prader-Willi syndrome group will have a confirmed diagnosis of Prader-Willi syndrome, as confirmed by molecular and cytogenetic testing \n\n Individuals enrolling in the Early-onset Morbid Obesity group will have a documented medical history of their weight exceeding 150% of the ideal body weight or a body mass index greater than 97% before the age of 4 years; they will also be under the age of 30 years. \n\n ", - "exclusion_criteria": ": \n\n Known genetic, chromosomal, or hormonal cause of cognitive impairment other than Prader-Willi syndrome", - "brief_summary": "Prader-Willi syndrome (PWS) is a rare genetic disorder that affects about 1 in 14,000 people in the United States. As the most commonly identified genetic cause of obesity, PWS is often confused with Early-onset Morbid Obesity (EMO). Individuals with EMO show some signs of PWS, but clinically do not have PWS. The purpose of this study is to evaluate the clinical features and genetic basis of PWS and EMO, and to determine how these conditions affect a person throughout a lifetime.", - "NCTID": "NCT00375089" - }, - { - "brief_title": "Beta-Blocker in Chronic Obstructive Pulmonary Disease (COPD) Study", - "phase": "", - "drugs": "['bronchodilator response']", - "drugs_list": [ - "bronchodilator response" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "11.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of COPD \n\n > 40 years of age \n\n > 15 pack year smoking history \n\n ", - "exclusion_criteria": ": \n\n Contra-indication to beta-blocker use \n\n Severe COPD FEV1 < 30% or 1 L \n\n Not responsive the methacholine", - "brief_summary": "Smoking causes both smoking related lung disease (COPD) and ischaemic heart disease. These are very common conditions and many patients have both diseases. Beta-blocker drugs are extensively used in the treatment of angina, high blood pressure and after heart attacks to decrease symptoms and prolong life. Beta-agonists are used in COPD to decrease breathlessness and improve exercise tolerance. It used to be thought that beta-blockers cannot be used in COPD patients as they may make the breathlessness worse, but it has now been established that they can be used safely. Beta-blocker drugs and beta-agonists have 'opposite' effects on the body and the investigators do not know if they can work together or if they would cancel each other out. The investigators also do not know which of the different types of beta-blockers now available are better for COPD patients. This study will investigate what happens to the airways of people taking both of these drugs.", - "NCTID": "NCT00745043" - }, - { - "brief_title": "Effect of a Meal Replacement on Weight Loss Obesity Patients With Metabolic Syndrome", - "phase": "Phase 3", - "drugs": "['meal replacement group', 'control group']", - "drugs_list": [ - "meal replacement group", - "control group" - ], - "diseases": "['Abdominal Obesity-Metabolic Syndrome']", - "diseases_list": [ - "Abdominal Obesity-Metabolic Syndrome" - ], - "enrollment": "138.0", - "inclusion_criteria": "inclusion criteria: \n\n Body mass index more than or equal to 25 kg/m2 \n\n Patients with metabolic syndrome \n\n Patients who are on anti-hypertensive drugs, oral hypoglycemic drugs and lipid lowering drugs. \n\n ", - "exclusion_criteria": ": \n\n Uncontrolled diabetes patients \n\n Patients with gastrointestinal abnormalities \n\n Patients with cardiovascular diseases \n\n Patients with hematologic disorders \n\n Patients with Glomerular filtration rate less than 60 ml/min/1.73m2 \n\n Patients with drug or alcohol abuse \n\n Pregnancy and lactation", - "brief_summary": "The purpose of this study is to determine whether meal replacement, SlimWell \u00ae, is effective in the treatment of obesity patients with metabolic syndrome.", - "NCTID": "NCT02626741" - }, - { - "brief_title": "Abdominal Compression Elastic Support (ACES)", - "phase": "", - "drugs": "['Abdominal Compression Elastic Support']", - "drugs_list": [ - "Abdominal Compression Elastic Support" - ], - "diseases": "['Intradialytic Hypotension']", - "diseases_list": [ - "Intradialytic Hypotension" - ], - "enrollment": "13.0", - "inclusion_criteria": "inclusion criteria: \n\n Must be able to give informed consent for participation in this study \n\n Age \u2265 18 years \n\n A body weight > 100 lb or a body mass index > 18.5. \n\n End-stage renal disease with hemodialysis in-center three times per week \n\n Not missing any treatments in the preceding two weeks and in compliance with instructions from the health care provider. \n\n In the last month had at least two episodes of IDH (defined as having hypotensive symptoms such as dizziness, fainting, headache, nausea, vomiting, cramping, weakness, blurry vision and/or a decrease in systolic blood pressure (SBP) of more than 20 mmHg). \n\n Hemoglobin greater than or equal to 9.0 g/dL (hematocrit 27%) to hemoglobin of 15.0 g/dL (hematocrit 45%). \n\n ", - "exclusion_criteria": ": \n\n \u2022 Pregnancy (self-reported) \n\n Allergic to nylon, polyesters and latex. \n\n Not able to understand the English language \n\n Not able to disengage the ACES from compression \n\n Having an excessively low systolic blood pressure (SBP which is less than 90 mmHg) \n\n Hemoglobin less than 9.0 g/dL or greater than 15 g/dL \n\n Excessive intra-abdominal fluid pressure \n\n Respiratory distress \n\n Bleeding in the chest and abdomen \n\n Bleeding dyscrasia causing serious coagulation problem \n\n Raised intra-abdominal pressure \n\n Having the following cardiovascular, pulmonary and abdominal complications: \n\n Systolic congestive heart failure, defined as a systolic ejection fraction of less than 25% \n\n Coronary artery disease defined as having a history of myocardial infarction or hemo-dynamically significant stenosis on cardiac catheterization or acute or chronic angina \n\n Circulatory shock \n\n Head trauma and/or abdominal trauma in the past three months \n\n Mesenteric ischemia \n\n Active foot ulcer \n\n Pulmonary edema \n\n Uncontrolled Hypertension (defined as systolic pressure of 180 mm Hg or a diastolic pressure of 110 mm Hg or higher) - using the average blood pressures obtained at one prior recent dialysis session and the average blood pressures obtained at the screening trial session for ACES. \n\n Liver disease as defined as an elevated ALT, AST, and Alkaline Phosphatase 2.5 times the upper limit of normal on a prior lab from medical records. \n\n INR > 1.5 or use of coumadin \n\n Platelets < 100 \n\n Active infection \n\n The need to use anti-hypotensive drugs on the days the ACES belt is applied. \n\n If the average systolic blood pressure with anti-hypotensive drugs or without and made before hemodialysis treatment is less than 90 mmHg, then the ACES session will be postponed to the next treatment. If similar hypotension situation occurs in the next ACES/hemodialysis treatment, then the subject will be taken out of the ACES trial and be considered a screen fail.", - "brief_summary": "Hemodialysis (HD) patients with end stage renal disease (ESRD) experience higher rates of cardiovascular (CV) morbidity and mortality than do the general population and many populations with other chronic diseases. This exceptional risk is explained in part by known risk factors, such as diabetes, hypertension, and other uremia-related factors, including vascular calcification and stiffness, autonomic dysfunction, and a high burden of circulating inflammatory mediators. Recent studies suggest that blood pressure variability, especially intra-dialytic hypotension (IDH) is the most significant risk factor for these CV events. Studies have also shown that the use of IAB is capable of improving cardiovascular function for avoiding or minimizing the development of an orthostatic hypotensive episode (OHE) in patients with autonomic dysfunction, orthostatic hypotension (OH) in diabetes patients and children with orthostatic intolerance, and post-dialytic orthostatic hypotension (PDOH).~The investigators propose a study to examine the use of an abdominal compression elastic support (ACES) to prevent the development of IDH in patients who are known to be prone to these episodes. The ultimate goal is to facilitate more effective and safer dialysis therapy. The ACES has a configuration that is similar to a back-support work belt or an inflatable abdominal band (IAB). All of these devices are wrapped around to compress the abdomen at the waist.", - "NCTID": "NCT02159625" - }, - { - "brief_title": "Diabetes and Heart Disease Risk in Blacks", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cardiovascular Diseases', 'Diabetes', 'Obesity', 'Hypertension']", - "diseases_list": [ - "Cardiovascular Diseases", - "Diabetes", - "Obesity", - "Hypertension" - ], - "enrollment": "2000.0", - "inclusion_criteria": "IINCLUSION AND ", - "exclusion_criteria": " \n\n CRITERIA FOR INCLUSION: \n\n Ethnicity: Black \n\n This is a study of adult African Americans and Blacks that were born in Africa but are now living in the United States. As African American people are multi-ethnic, we will in this initial investigation, study two different groups of African American. To enroll participants must self-identify as African Americans and be born in the United States, with American born parents or be born in Africa with African born parents. In both groups we will study sex differences in the role of obesity and TG levels on cardiovascular disease. In the future, we plan to expand the study to include other groups which self-identify as African Americans (i.e.AfroCarribeans and Hispanic blacks). \n\n Only blacks are included in this study because the focus of this study is on gender differences in blacks in risk factors for CAD, specifically obesity, TG levels and TG related CAD risk factors. Unlike Caucasian women, premenopausal black women do not appear to be as protected from heart disease as a result of their gender. One model to study this apparent decrease in gender \n\n related cardioprotection in black women is to compare black men to black women. An alternative model would be to compare black women to Caucasian women. However, since the primary focus of this work is on gender differences rather than racial differences comparing black women to men is a superior model. Other racial groups do not share the loss of gender-related cardioprotection found in blacks, and have been excluded. Further the advantage of comparing black men and women is that this comparison provides a better control of dietary, cultural and genetic factors. \n\n Age: The age range of the participants will be between 18 and 70 years. As stated in the original protocol on page 14: Future investigations are planned which will involve similar comparisons between premenopausal and postmenopausal black women and between whites and blacks. To investigate risk for glucose intolerance, diabetes and cardiovascular risk factors, it is no longer sufficient to maintain the age range between 18 and 50 years. We need to expand to an age range with an increased prevalence of these risk factors. \n\n Medical History: To participate in the study subjects should identify themselves as healthy. This is important so the broadest possible sample of people will enroll. The fact that people are healthy will be confirmed by the history, physical and laboratory tests done as part of the screening visit. People with established coronary artery as evidenced by history of myocardial infarction, coronary artery bypass surgery or PTCA will be allowed to participate if they are not currently having angina. \n\n CRITERIA FOR EXCLUSION: \n\n Black Ethnicity other than American or African. \n\n As stated in the inclusion criteria black people are a multi-ethnic group. In this initial investigation we are focusing on African Americans who are American born and Africans living in the United States who are African born. In the future, we will expand the study to include other groups of blacks such as individuals of Afro-Caribbean and Hispanic blacks. \n\n Medications: People who take medications that are known to alter the parameters which are under investigation in this study will be excluded. People taking medications to treat hyperlipidemia will be included but analyses will be adjusted to take this into account. Subjects on thyroid hormone replacement will be included if their TSH is normal. \n\n Diabetes: Because diabetes affects insulin sensitivity and TG levels all people with diabetes even if the diabetes is controlled with diet alone will not be enrolled in the study. \n\n Pregnant or Breastfeeding: Women who are pregnant, breastfeeding, or have an infant that is less than four months of age will be excluded. This is because the physiologic changes associated with pregnancy, breastfeeding or recent childbirth affect the parameters under study. \n\n Menstrual History: Now that postmenopausal women are included, menstrual history will be taken but women with irregular menses and hysterectomy will not be excluded. Women between the ages of 40 and 55 years will have FSH checked for proper characterization. Women 56 years of age and older will be assumed to be postmenopausal. However, women on any type of injectable hormonal contraception will be excluded because hormonal contraception affects both TG levels and glucose metabolism.", - "brief_summary": "It is unknown if obesity contributes to the development of heart disease in African American men and women.~This study was created to determine whether there is a relationship between sex and body size and the incidence of heart disease in African American men and women. Researchers will attempt to associate obesity with the presence of heart disease risk factors. Risk factors that will be studied include; total body fat, body fat distribution, fat content of the blood (triglyceride concentration, low density lipoproteins [LDL], and high density lipoproteins [HDL]), how fast fat is removed from the blood, and how well insulin works in the body.~Scientific studies have shown that obesity and increased levels of fat content in the blood are important risk factors for heart disease in Caucasian women. However, similar studies in African American women have failed to show the same correlation. In fact, it appears that African American women in all three body weight groupings, nonobese, overweight, and obese experience high death rates due to heart disease. In addition, prior research has shown that obese African American men tend to have elevated levels of fat in the blood while African American women have normal blood fat levels. Therefore, if high levels of triglycerides (fat found in the blood) are not seen in non-diabetic obese African American women, it cannot be considered a risk factor in this population. This suggests that studies conducted on Caucasian women may not provide insight into heart disease risk factors in African American women.~The study will take 2000 healthy non-diabetic African American men and women (ages 18-70) and body mass index 3 subgroups; nonobese, overweight and obese. Diabetes undeniably increases the risk of heart disease. Therefore patients suffering from diabetes will not be included in the study. Candidates for the study will undergo a series of tests and examinations over 2 outpatient visits. Subjects will have body fat analyses, resting energy expenditure measurements, an EKG (electrocardiogram), and specific blood tests.~Researchers believe this study will provide significant insight into the causes of obesity and heart disease in African Americans.", - "NCTID": "NCT00001853" - }, - { - "brief_title": "Osteopathic Treatment of Low Back Pain", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Low Back Pain']", - "diseases_list": [ - "Low Back Pain" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n between the age of 19 and 55 years old, \n\n able to walk without assistance and /or assistive devices at least 4.7 meters. \n\n have adequate hearing acuity to detect verbal instructions. \n\n have adequate visual acuity to walk safely in usual ambient lighting without holding onto objects. \n\n be able to speak and comprehend English, \n\n have sufficient cognitive ability to follow instructions, and to provide informed consent, as defined by a Mini Mental Status Examination score of greater than 23 out of 30, performed by the research coordinator. \n\n ", - "exclusion_criteria": ": \n\n have had neurological signs and symptoms, or complications such as tumor or infection. \n\n are active in a claim pertaining to a motor vehicle accident or work injury or under any litigation for their pain. \n\n have had previous osteopathic treatment in the last year. \n\n had more than one abdominal surgery, or spinal fracture, or structural deformity such as scoliosis or spondylolithesis (Hubley-Kozey, 2002) \n\n have severe cardiopulmonary disease as determined by a health questionnaire with symptoms such as shortness of breath or chest pain on mild exertion or at rest, \n\n history of severe neurological disorder that impairs balance and mobility eg stroke, Parkinson's disease, peripheral neuropathy \n\n have pain that leads to severe discomfort with minimal movement, \n\n have significant musculoskeletal impairment e.g. arthritis that leads to severe discomfort with walking that could lead to an abnormal gait, \n\n have cognitive compromise impairing ability to care for oneself, and ability to provide informed consent, \n\n have dizziness while standing, \n\n have a history of falls in previous month that might make it unsafe to participate in a gait study", - "brief_summary": "Eighty percent of Canadians experience low back pain (LBP) at some point in their life (Waddell, 1987), with a point prevalence of up to 30 percent (O'Sullivan, 2005; Waddell, 1987). Low back pain has severe economic ramifications. Most incidents of low back pain occur during the prime working years of life, with an estimated cost to the economy at $14,744 Canadian dollars per person per year (Health Canada, 1998). Indirect costs in the form of long-term disability were highest for disorders of arthritis and chronic back pain (Health Canada, 1998). It has been estimated that 12 percent of patients will experience disability within one year after their first episode of low back pain (Banner, 2006). Evidence based diagnosis and treatment is important for desirable outcomes.~The investigators predict that there will be changes in A) trunk muscle electromyographic patterns and in temporo-spatial gait patterns following osteopathic treatment.", - "NCTID": "NCT00883987" - }, - { - "brief_title": "Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease", - "phase": "Phase 4", - "drugs": "['Metformin', 'placebo']", - "drugs_list": [ - "Metformin", - "placebo" - ], - "diseases": "['Left Ventriclar Mass']", - "diseases_list": [ - "Left Ventriclar Mass" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n They had to have normal glucose tolerance. \n\n They had to have either angiographically documented coronary artery disease or a previous history of myocardial infarction. \n\n They were required to have an office BP < 130/80 mm Hg \n\n The presence of LVH on echocardiography (American Society of Echocardiography criteria LVM index [LVMI] > 115 g/m2 for men and > 95 g/m2 for women). \n\n ", - "exclusion_criteria": ": \n\n They were currently prescribed metformin. \n\n They had renal and liver dysfunction, heart failure, or malignancy, or were unable to give informed consent. \n\n Patients with contraindications to cardiac magnetic resonance (CMR) (pacemakers, claustrophobia) were also excluded, as were pregnant or lactating women.", - "brief_summary": "Cardiovascular disease is the most common cause of death in the world. Most of the attention in treating ischemic heart disease (IHD) is understandably directed toward treating coronary artery disease. However there are other treatable culprits in these patients.~Left ventricular hypertrophy (LVH) is widespread in IHD patients, even in the absence of hypertension. It is a strong predictor of cardiovascular events and all-cause mortality. In one study, the presence of LVH was a stronger predictor of mortality than either multivessel cor-onary disease or impaired LV function.~Metformin is an antihyperglycemic agent with a history of successful use in type 2 diabetes. In the UKPDS (United Kingdom Prospective Diabetes Study), metformin was associated with a 39% lower risk of myocardial infarction compared with conventional therapy. Metformin also offered dual benefits of improving vascular function and lessening ischemia in nondiabetic patients.~Hence, the main aim of this study was to assess whether metformin could regress LVM in patients with IHD. The secondary aim was to assess the effect of metformin on LV volumes and endothelial function in this patient group.", - "NCTID": "NCT01879293" - }, - { - "brief_title": "Enoximone Plus Extended-Release Metoprolol Succinate in Subjects With Advanced Chronic Heart Failure", - "phase": "Phase 3", - "drugs": "['Enoximone', 'Metoprolol succinate', 'Placebo to match enoximone', 'Placebo to match metoprolol succinate']", - "drugs_list": [ - "Enoximone", - "Metoprolol succinate", - "Placebo to match enoximone", - "Placebo to match metoprolol succinate" - ], - "diseases": "['Heart Failure, Congestive']", - "diseases_list": [ - "Heart Failure", - "Congestive" - ], - "enrollment": "175.0", - "inclusion_criteria": "inclusion criteria \n\n In order to be considered an eligible subject, all of the following entry criteria must be met: \n\n Subjects must be competent to provide informed written consent. Subjects must sign an IRB/IEC approved informed consent form prior to the initiation of any study procedures. \n\n Subjects must be 18 years of age or older. \n\n Subjects must have ischemic or nonischemic cardiomyopathy with symptoms of NYHA Class III or IV chronic heart failure. \n\n Subjects must have a LVEF of less than or equal to 35%, measured within 60 days of the Screening Visit. LVEF must be assessed by radionuclide ventriculography (MUGA). If the subject has experienced any cardiovascular events, has undergone any interventions, or received any changes in treatment that may have affected LV function since the most recent EF measurement, an LVEF measurement must be completed prior to the subject being randomized. \n\n Subjects must have a left ventricular end diastolic dimension (LVEDD) of >2.7 cm/m2 as measured by 2-D ECHO within 12 months of the Screening Visit. \n\n Subjects must be on optimal conventional heart failure therapy (with the exception of a beta-blocker), including an ACEI for at least 30 days prior to the Screening Visit, or the subject must have had a trial of an ACEI and proven to be intolerant, or the subject must be taking an ARB for at least 30 days prior to the Screening Visit or proved to be intolerant. Optimal conventional therapy may also include spironolactone, digitalis glycosides, diuretics, or other vasodilators. \n\n Subjects must have failed the initiation, or the up-titration, of a beta-blocker drug due to hemodynamic intolerance within 12 months prior to the Screening Visit. Failure to tolerate beta-blockade for hemodynamic reasons is defined as worsening signs and symptoms of chronic heart failure, hypotension accompanied with symptoms, or evidence of organ hypoperfusion, which in the judgment of the treating physician precluded further treatment with the beta-blocker. This beta-blocker intolerance must have been documented prior to Screening, and a narrative description of the intolerance must be approved by Myogen prior to Randomization. \n\n ", - "exclusion_criteria": " \n\n Subjects who meet any one of the following criteria will be deemed ineligible for participation in the study: \n\n Subjects with CHF due to or associated with uncorrected primary valvular disease, uncorrected thyroid disease, obstructive/hypertrophic cardiomyopathy, pericardial disease, amyloidosis, active myocarditis, malfunctioning artificial heart valve, uncorrected congenital heart disease, isolated right-sided heart failure, or primary pulmonary hypertension. \n\n Subjects who have undergone a cardiac revascularization, valvular surgery, or bi-ventricular resynchronization procedure within 60 days prior to the Screening Visit. \n\n Subjects listed for heart transplantation who are expected to be transplanted within 6 months of randomization. \n\n Subjects who have had a myocardial infarction within 90 days prior to the Screening Visit. \n\n Subjects with an ECG recorded at the Screening Visit showing any of the following: 1) evidence of transmural ischemia (dynamic ST elevation or ST elevation associated with ischemic symptoms), or 2) ventricular tachycardia (VT) or premature ventricular complexes (PVCs) associated with symptoms, or 3) VT of greater than or equal to 6 beats \n\n Subjects with sustained (>15 seconds) VT, unless precipitated by an event such as an acute myocardial infarction, induction by catheter placement, or by an electrophysiology procedure, or addressed by AICD placement. \n\n Subjects with an AICD that has fired for any ventricular arrhythmia within 90 days of the Randomization Visit. \n\n Subjects with a documented diagnosis of angina that meets either of the following criteria: 1) angina diagnosed as unstable at any time within the 60 days prior to the Screening Visit or 2) angina is the primary symptom that limits daily physical activity \n\n Subjects who have had ventricular reduction surgery or cardiac myoplasty. \n\n Subjects on a mechanical assist device. \n\n Subjects with evidence of a concomitant disease that may interfere with the natural course of the subject's underlying heart failure for the duration of the trial. \n\n Subjects having a concomitant life-threatening disease for which their life expectancy is estimated to be less than one year. \n\n Subjects with uncontrolled insulin-dependent diabetes mellitus with a history of frequent hypoglycemic episodes or frequent hospitalizations for hyperglycemia. \n\n Subjects on the following concomitant medications at the time of Screening are excluded from participating in the study: 1) Calcium antagonists other than amlodipine or felodipine; 2) Flecainide, encainide, propafenone, sotalol, dofetilide or disopyramide; 3) Subjects receiving i.v. positive inotropic agents within seven days of the Screening Visit or Randomization Visit; 4) Subjects receiving a human BNP, including nesiritide, within seven days of the Screening Visit or Randomization Visit; 5) Subjects receiving oral or i.v. type-III PDE inhibitors within seven days of the Screening Visit or Randomization Visit. \n\n Subjects with a contraindication to treatment with a positive inotropic agent (defined as a serious adverse event attributed to previous treatment with a positive inotrope). \n\n Subjects with a known contraindication to beta-blocker therapy. This may include beta-agonist-dependent chronic obstructive pulmonary disease or asthma, a heart rate <55 BPM, the presence of second- or third-degree heart block without an implanted pacemaker, and first-degree heart block with a PR interval >220 milliseconds. \n\n Subjects with active hepatic (screening serum total bilirubin greater than or equal to 3.0 mg/dL), renal (screening serum creatinine greater than or equal to 2.0 mg/dL), hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease, which in the opinion of the Investigator, may adversely affect the safety and efficacy of the study drug or the life span of the subject. \n\n Subjects known to abuse or actively abusing alcohol or illicit drugs. Abuse of alcohol is defined as the usual daily intake of more than 100 grams of ethanol per day, or more than approximately 6 twelve-ounce bottles of beer, one 750 mL bottle of wine or 250 mL of 80 proof spirits. \n\n Subjects with a serum potassium <4.0 mEq/L or >5.5 mEq/L at Screening. \n\n Subjects with a serum digoxin of >1.2 ng/mL at Screening are excluded. \n\n Pregnant women and women at risk of becoming pregnant (i.e., not using effective methods of birth control). \n\n Subjects who have participated in a clinical trial involving another investigational drug or device within 30 days of the Screening Visit or at any time during the study. \n\n Subjects who have demonstrated noncompliance with previous medical regimens. \n\n Subjects who are hospitalized at the time of the Randomization Visit and are not hemodynamically stable, or for whom there is an acute cardiac or non-cardiac illness that requires further hospitalization.", - "brief_summary": "Beta-blocker medications have been shown to improve heart function and prolong the lives of patients with chronic heart failure (CHF). Some people with advanced CHF have difficulty taking beta-blocker medications due to troublesome side effects, such as low blood pressure and/or low heart rate, severe tiredness, dizziness, or shortness of breath. In other words, they have difficulty tolerating beta-blocker medications. The purpose of this study is to determine if enoximone can improve a patient's ability to tolerate a beta-blocker medication.", - "NCTID": "NCT00077948" - }, - { - "brief_title": "Trial of the MEND Childhood Obesity Treatment Program", - "phase": "", - "drugs": "['MEND Childhood Obesity Program', 'Control Group']", - "drugs_list": [ - "MEND Childhood Obesity Program", - "Control Group" - ], - "diseases": "['Obesity']", - "diseases_list": [ - "Obesity" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Children enrolled in the MEND Programme who are yet to be given a start date for the programme. \n\n Aged between 7-13 years old. \n\n Overweight or obese as defined by a BMI which falls above the 91st centile on the boys/girls BMI chart UK cross-sectional reference data:1997/1). \n\n Clinically well with no known chronic illness. \n\n ", - "exclusion_criteria": ": \n\n Age less than 7 years or older than 13. \n\n Known chronic illness.", - "brief_summary": "The number of children who are obese in the UK is steadily increasing with both short and long term consequences for health. The aim of this study is to determine whether the MEND Programme (a new national initiative for the treatment of childhood obesity) is a successful and sustainable treatment for childhood obesity and obesity related health problems.~300 overweight and obese children will be randomly assigned to start immediately on the MEND Programme for 6 months or join a waiting-list control group for 6 months. Measurements of health outcomes will be taken at baseline, and at 6, 12 and 24 months after the Programme. After 6 months of waiting-list time, the control group will follow the same protocol as the immediate starters. The researchers will be unaware (blinded) to which group each child has been assigned to. The study will examine the effects of the MEND Programme on body composition, cardiovascular health and psychological health.", - "NCTID": "NCT00974116" - }, - { - "brief_title": "Combination of OLMesartan and CCB or Low Dose Diuretics in High Risk Elderly Hypertensive Patients Study (COLM-Study)", - "phase": "Phase 4", - "drugs": "['olmesartan medoxomil / amlodipine or azelnidipine', 'olmesartan medoxomil / low dose thiazide type drug']", - "drugs_list": [ - "olmesartan medoxomil / amlodipine or azelnidipine", - "olmesartan medoxomil / low dose thiazide type drug" - ], - "diseases": "['Hypertension', 'Cardiovascular Disease', 'Diabetes']", - "diseases_list": [ - "Hypertension", - "Cardiovascular Disease", - "Diabetes" - ], - "enrollment": "5141.0", - "inclusion_criteria": "inclusion criteria: \n\n Outpatients aged 65 years or older, and less than 85 years (at the time of informed consent), regardless of sex \n\n Systolic blood pressure (SBP) \u2265140 mmHg or diastolic blood pressure (DBP) \u226590 mmHg in a sitting position on two consecutive measurements at clinic during use of 1 or more antihypertensive medications. \n\n Systolic blood pressure (SBP) \u2265160 mmHg or diastolic blood pressure (DBP) \u2265100 mmHg in a sitting position on two consecutive measurements at clinic without antihypertensive medication. \n\n Require at least one of the following medical history or risk factors \n\n Medical history \n\n Cerebrovascular accident: cerebral infarction, brain hemorrhage, subarachnoid hemorrhage\uff086 months or more prior to registration\uff09 \n\n Myocardial infarction, coronary revascularization (PCI or CABG) \uff086 months or more prior to registration\uff09 \n\n Angina pectoris (except for the patients having history of hospitalization within 6 months prior to registration) \n\n Risk factors \n\n Male \n\n Current diabetes mellitus, fasting glucose \u2265 110mg/dL or postprandial glucose \u2265 140mg/dl \n\n Hypercholesterolemia (Total cholesterol \u2265 260mg/dL) \n\n Low HDL cholesterolemia (HDL-C <40mg/dL) \n\n Microalbuminuria (albumin/cr \u2265 30mg/gCr) or proteinuria (protein \u2265 1\uff0b) \n\n Left ventricular hypertrophy (ST-T change in the ECG and SV1\uff0bRV5 \u2265 35mm, or left ventricular mass index: male \u2265 125 g/m2, female \u2265 110 g/m2) \n\n ", - "exclusion_criteria": ": \n\n Secondary hypertension or malignant hypertension \n\n History of cerebrovascular accident (including TIA) or myocardial infarction within 6 months before registration \n\n Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) done within 6 months before registration or scheduled \n\n History of hospitalization for angina pectoris or heart failure within 6 months before registration \n\n Severe heart failure (New York Heart Association [NYHA] functional class III or more severe) \n\n Complications of atrial fibrillation, atrial flutter or severe arrhythmia \n\n Severe hepatic or renal dysfunction (including current treatment of dialysis or renal dysfunction with serum creatinine \u2265 2.0mg/dL) \n\n Not appropriate for change to the study drugs from current therapy for concurrent disease including coronary diseases (i.e. calcium channel blockers, diuretics, etc) \n\n History of serious side effect from study drugs (AT1 subtype angiotensin II receptor antagonist, calcium channel blocker, diuretic) \n\n Life threatening condition (malignant tumor, etc) \n\n Not suited to be study subject judged by a study physician", - "brief_summary": "The purpose of this study is to investigate which combination therapy is more effective in reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive patients: AT1 subtype angiotensin II receptor antagonist/calcium channel blocker or AT1 subtype angiotensin II receptor antagonist/low dose diuretic.", - "NCTID": "NCT00454662" - }, - { - "brief_title": "OlmeSartan and Calcium Antagonists Randomized (OSCAR) Study", - "phase": "Phase 4", - "drugs": "['Olmesartan medoxomil', 'Calcium channel blockers (amlodipine, azelnidipine)']", - "drugs_list": [ - "Olmesartan medoxomil", - "Calcium channel blockers (amlodipine", - "azelnidipine)" - ], - "diseases": "['Hypertension', 'Cardiovascular Diseases']", - "diseases_list": [ - "Hypertension", - "Cardiovascular Diseases" - ], - "enrollment": "1000.0", - "inclusion_criteria": "inclusion criteria: \n\n Outpatients aged 65 years or older, and less than 85 years (at the time of informed consent), regardless of sex \n\n Current antihypertensive treatment with monotherapy \n\n SBP \u2265 140mmHg or DBP \u2265 90mmHg in a sitting position on two measurements on two clinic visits \n\n At least one of the following risk factors: \n\n Diabetes mellitus Type 2; \n\n History of cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemic attack (more than 6 months before giving informed consent); \n\n Diagnosis of asymptomatic cerebrovascular disease; \n\n History of myocardial infarction (more than 6 months before giving informed consent); \n\n Diagnosis of angina pectoris or heart failure (New York Heart Association [NYHA] functional classification I or II); \n\n Diagnosis of left ventricular hypertrophy (thickness of the wall of interventricular septum \u2265 12mm on echocardiography or Sv1+Rv5 \u2265 35mm on electrocardiography before informed consent); \n\n Diagnosis of aortic aneurysm; \n\n History of aortic dissection (more than 6 months before giving informed consent); \n\n Diagnosis of arteriosclerotic peripheral arterial obstruction (Fontaine classification from 2 to 4); \n\n Serum creatinine: 1.2-2.5mg/dL (male); 1.0-2.5mg/dL (female); \n\n Proteinuria: \u2265 +1 (or \u2265 0.3g/g\uff65Cr. estimated from 24-hour urine collection or random urinary protein corrected by urine creatinine). \n\n ", - "exclusion_criteria": ": \n\n Secondary hypertension or malignant hypertension \n\n Heart failure (NYHA functional classification III or IV) \n\n Required treatment for malignant tumor \n\n Serious liver or renal dysfunction (serum creatinine > 2.5mg/dL or with dialysis treatment) \n\n Not appropriate for change to the test drugs from current therapy for hypertension or coronary diseases (i.e. calcium channel blockers, \u03b2-blockers, thiazide diuretics, etc.) \n\n History of serious adverse drug reactions to angiotensin II receptor blockers or calcium channel blockers \n\n Patients with other serious reasons (i.e. illness, significant abnormalities, etc.) that investigators judge inappropriate for the study", - "brief_summary": "The purpose of this study is to investigate whether high-dose angiotensin II receptor blocker (ARB) monotherapy or combination therapy with ARB and calcium channel blockers is more effective in reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive patients not adequately controlled by standard dose ARB alone.", - "NCTID": "NCT00134160" - }, - { - "brief_title": "The Nitrate and Bone Study: Effects of Nitrates on Osteoporosis", - "phase": "Phase 3", - "drugs": "['Nitroglycerin ointment 15 mg/day daily for 24 month', 'Placebo ointment daily for 24 month']", - "drugs_list": [ - "Nitroglycerin ointment 15 mg/day daily for 24 month", - "Placebo ointment daily for 24 month" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "243.0", - "inclusion_criteria": "inclusion criteria: \n\n Women aged 50 and older \n\n Lumbar spine BMD (L1 to L4) T score between 0 and -2.0 \n\n At least 3 years postmenopausal \n\n ", - "exclusion_criteria": ": \n\n Prior low trauma hip or vertebral fracture \n\n Total hip or femoral neck T score of <-2.0 \n\n Bone disorders other than osteopenia (e.g., hyperparathyroidism or Paget's disease) \n\n Treatment within six months of study entry with androgen, calcitonin, estrogen, progesterone, fluoride in a tablet form, raloxifene, tamoxifen, etidronate, prednisone or an equivalent at 5 mg/d for 12 months or greater, lithium or anticonvulsants \n\n Alendronate or risedronate use for at least four weeks, within the last three years \n\n Current treatment with nitrates \n\n Systolic blood pressure of =<100 mm Hg or diastolic blood pressure >=100 mm Hg at the baseline screening examination \n\n Abnormal electrocardiogram (ECG) at the baseline screening examination \n\n history of myocardial infarction, angina, valvular or congenital heart disease \n\n Disabling conditions that may interfere with follow-up visits \n\n Inability to give informed consent \n\n Migraine headaches \n\n Hypersensitivity to nitrates", - "brief_summary": "Osteoporosis or thinning of the bones affects in 1 in 4 Canadian women and 1 in 8 Canadian men. Moreover, while the rates of osteoporosis among Canadians are stabilizing, worldwide the number of people afflicted with osteoporosis continues to rise. The most serious complication of osteoporosis is a broken bone or fracture. Fractures due to osteoporosis can result in long hospital stays, dependence on others, and premature death. While there are several medications that prevent osteoporosis they all have side effects. For example, postmenopausal women who take hormone replacement therapy (HRT) are at increased risk of breast cancer and heart disease. In addition, drugs to prevent osteoporosis are expensive and not available worldwide. Therefore, it is essential that researchers continue to identify and test new medications for the prevention of osteoporosis.~The purpose of the research is to determine if nitrates, a group of drugs that are widely available, inexpensive, and commonly used to treat chest pain or angina, can prevent osteoporosis in women. If the researchers find that nitrates prevent osteoporosis, a widely available, inexpensive treatment for osteoporosis prevention that does not have any long term side effects would have been identified. This will improve the health of patients with osteoporosis worldwide.", - "NCTID": "NCT00252421" - }, - { - "brief_title": "Healthy Body Study", - "phase": "", - "drugs": "['Healthy Weight', 'Controlled Intervention']", - "drugs_list": [ - "Healthy Weight", - "Controlled Intervention" - ], - "diseases": "['Obesity']", - "diseases_list": [ - "Obesity" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n \u2265 12 years old \n\n Body image concerns \n\n Sub-threshold Eating disorder symptomatology \n\n Overweight but not obese (BMI between the 85th and 95th percentile for children/adolescents and BMI between 25 and 30 kg/m2 for adults 21-24) \n\n Be able to commit to weekly 1-hour sessions for six weeks and 3 separate assessment visits to the MSAHC \n\n ", - "exclusion_criteria": ": \n\n Current eating disorder (anorexia nervosa, bulimia nervosa or binge eating disorder) \n\n absence of body image concerns \n\n normal or obese body weight (< 85th or \u2265 95th BMI percentile)", - "brief_summary": "Few obesity prevention programs have produced weight gain prevention effects that persist over long-term follow-up and those that have are extremely lengthy, averaging 52 hr in duration, making implementation difficult and costly. The 2010 US Preventative Services Task Force (USPSTF) recommendations for treating child & adolescent obesity state that programs should have \u2265 25 hr of comprehensive treatment including dietary, physical activity and behavioral counseling, and that programs with < 25 hr usually do not produce improvements. The implication is that, if centers cannot provide this level of service (as most cannot), it is not worth providing any kind of treatment at all. In extreme exception to this, an intensive 3-hr non-restrictive obesity prevention program involving participant-driven healthy lifestyle improvement plans designed to bring caloric intake and output into balance (Healthy Weight) has been found to significantly reduce increases in BMI and obesity onset relative to alternative interventions and assessment-only controls through 3-yr follow-up. We propose to test an extended 6-hr version of the Healthy Weight intervention in a sample of primarily low SES, minority adolescents and young adults who are overweight and report body dissatisfaction and subthreshold eating disorder symptoms, as these are prevalent risk factors for obesity. We will test the hypothesis that participants assigned to the Healthy Weight vs. control intervention will have significantly lower BMI and % body fat during follow-up. Secondary outcomes will include body dissatisfaction, depressive symptoms, and eating disorder symptoms. 300 adolescents and young adults at high risk for future weight gain by virtue of their age, BMI percentile, body dissatisfaction and eating disorder symptomatology will be randomized to Healthy Weight or weight control educational video. Participants will complete assessments of BMI, body composition, potential mediators, and other outcomes at pretest, posttest and 6--mo follow-ups (in yr 1). Thus, to refute the USPSTF recommendations statement, we propose to show that a 6-hr intervention led by graduate students can produce significant reductions in risk for both obesity and eating disorders, suggesting this inexpensive and brief intervention could and should be rolled out nationwide.~Primary Aim: To test the hypothesis that Healthy Weight will significantly reduce increases in BMI, % body fat, and risk for onset of obesity during follow-up.~Secondary Aim: To test the hypothesis that Healthy Weight will significantly reduce body dissatisfaction, depressive symptoms, and eating disorder symptoms.~NOTE: THIS STUDY IS ONLY OPEN TO PATIENTS AT THE MOUNT SINAI ADOLESCENT HEALTH CENTER", - "NCTID": "NCT02011646" - }, - { - "brief_title": "Influence of Amlodipine on the Mortality of Patients With End-Stage Renal Failure", - "phase": "Phase 4", - "drugs": "['Amlodipine', 'Placebo']", - "drugs_list": [ - "Amlodipine", - "Placebo" - ], - "diseases": "['Kidney Failure, Chronic']", - "diseases_list": [ - "Kidney Failure", - "Chronic" - ], - "enrollment": "356.0", - "inclusion_criteria": "inclusion criteria: \n\n End-stage renal disease \n\n Hemodialysis \n\n Hypertension \n\n Written informed consent \n\n ", - "exclusion_criteria": ": \n\n Hypotension of less than 90 mmHg systolic \n\n High-grade aortic stenosis \n\n Heart failure of NYHA stage III and IV \n\n Acute myocardial infarction (within the last 4 weeks) \n\n Acute heart failure \n\n Known allergy to the medicament amlodipine or other constituents of the medicament \n\n Severe disorders of liver function \n\n Pregnancy and breast-feeding", - "brief_summary": "Patients with end-stage renal failure have a markedly higher mortality because of cardiovascular events in comparison with the normal population. Disorders in the calcium metabolism, such as calcification of the vessel walls, occur very frequently. There are indications that calcium channel blockers are capable of lowering the cardiovascular mortality in patients with end-stage renal failure.~It is intended to carry out a prospective, randomized, double-blind, placebo-controlled, multicenter study in order to find out if the calcium channel blocker amlodipine is able to reduce the mortality of patients with end-stage renal failure.~The investigation will be carried out after suitable explanation and written informed consent in 356 patients aged between 18 and 90 years with end-stage renal failure and chronic haemodialysis treatment. The patients will be randomized to either treatment with amlodipine 10 mg/day or placebo. The occurrence of events will be documented and evaluated prospectively over a period of 30 months.", - "NCTID": "NCT00124969" - }, - { - "brief_title": "Resistance Exercise Effects on Fear Avoidance and Physical Function in Obese Older Adults With Low Back Pain", - "phase": "", - "drugs": "['normal medical care and follow up', 'Isolated Lumbar Resistance Exercise Program', 'Total Body Resistance Exercise Program']", - "drugs_list": [ - "normal medical care and follow up", - "Isolated Lumbar Resistance Exercise Program", - "Total Body Resistance Exercise Program" - ], - "diseases": "['Low Back Pain', 'Obesity']", - "diseases_list": [ - "Low Back Pain", - "Obesity" - ], - "enrollment": "72.0", - "inclusion_criteria": "inclusion criteria: \n\n chronic low back pain for >6 months \n\n >3 pain episodes per week \n\n waist circumferences \u2265102 cm for men \n\n waist circumferences \u2265 88 cm for women \n\n willing and able to participate in regular exercise for 14 weeks \n\n using pain medications to control low back pain \n\n free of abnormal cardiovascular responses during a screening graded maximal walk test \n\n ", - "exclusion_criteria": ": \n\n unable to walk \n\n participating in regular resistance exercise training (>3X week) in the past 6 months \n\n pain symptoms are too severe and prevent strength testing or walking \n\n acute back injury \n\n spinal stenosis that precludes walking one block due to neurogenic claudication \n\n back surgery within the past 2 years \n\n current use of weight loss interventions (drugs; exercise interventions)", - "brief_summary": "The purpose of this study is to determine if a 4 month resistance exercise program reduces the severity of low back pain, pain-related fear avoidance and improves mobility compared to standard care.", - "NCTID": "NCT01250262" - }, - { - "brief_title": "Dietary Nitrate in COPD", - "phase": "", - "drugs": "['Nitrate rich beverage', 'Nitrate free beverage']", - "drugs_list": [ - "Nitrate rich beverage", - "Nitrate free beverage" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria: \n\n Information consenting out-patients with a previous physician diagnosis of COPD \n\n Clinically stable \n\n Ambulatory \n\n ", - "exclusion_criteria": ": \n\n Subjects who required supplemental oxygen for exercise \n\n Subjects with pulmonary hypertension and angina \n\n Intolerant to beetroot \n\n Insulin dependent diabetes \n\n Thyroid disease", - "brief_summary": "The acute consumption of dietary nitrate has been shown to improve exercise capacity in athletes, healthy adults and subjects with peripheral vascular disease. Many COPD patients have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption, in the form of beetroot juice, might increase incremental shuttle walk test (ISWT) distance in COPD subjects.", - "NCTID": "NCT02148289" - }, - { - "brief_title": "Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument", - "phase": "Phase 3", - "drugs": "['Macitentan']", - "drugs_list": [ - "Macitentan" - ], - "diseases": "['Pulmonary Arterial Hypertension']", - "diseases_list": [ - "Pulmonary Arterial Hypertension" - ], - "enrollment": "4.0", - "inclusion_criteria": "inclusion criteria: \n\n Signed informed consent prior to any study-mandated procedure. \n\n Patients with PAH who completed study AC-055-401 \n\n Women of childbearing potential must: \n\n Have a negative urine pregnancy test at Visit 1 and agree to perform monthly serum pregnancy tests. \n\n Agree to use two methods of contraception from Visit 1 until 1 month after study drug discontinuation. \n\n ", - "exclusion_criteria": ": \n\n Patients who prematurely discontinued study drug in study AC-055-401 \n\n Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to become pregnant during the study \n\n Known hypersensitivity to macitentan or its excipients or drugs of the same class", - "brief_summary": "SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401 study.", - "NCTID": "NCT01847014" - }, - { - "brief_title": "Effectiveness of the Compression Belt for Patients With Sacroiliac Joint Pain", - "phase": "", - "drugs": "['Lumbopelvic stabilization exercise', 'Sacroiliac joint belt']", - "drugs_list": [ - "Lumbopelvic stabilization exercise", - "Sacroiliac joint belt" - ], - "diseases": "['Low Back Pain']", - "diseases_list": [ - "Low Back Pain" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n unilateral pain near the sacroiliac joint that does not extend pass the knee \n\n positive result on 2 of 6 sacroiliac joint provocation tests: \n\n compression test \n\n distraction test \n\n posterior shear test \n\n Gaenslens' test (left and right) \n\n sacral thrust test \n\n ", - "exclusion_criteria": ": \n\n current pregnancy or pregnancy in the last 6 months \n\n history of surgery to lumbar spine, pelvis, chest, abdomen \n\n history of congenital lumbar or pelvic anomalies \n\n any neurological signs in the lower extremity", - "brief_summary": "The purpose of this randomized clinical trial is to examine the usefulness of the addition of a pelvic compression belt to a lumbopelvic stabilization program for patients with sacroiliac joint pain by comparing lumbopelvic stabilization exercises with a pelvic compression belt to lumbopelvic stabilization exercises alone. Outcome measures including the Modified Oswestry Low Back Pain Disability Index (OSW), the percentage change of TrA and IO muscle thickness (i.e. muscle contraction from rest to contract) utilizing ultrasound imaging, the Numeric Pain Rating Scale (NPRS) for pain, and a subjective rating of overall perceived improvement using the Global Rating of Change (GROC) scale will be collected. Hypothesis: The OSW scores and NPRS scores will be lower for those who receive the compression belt in addition to the lumbopelvic stabilization program as compared to those who receive the lumbopelvic stabilization alone. The percent change of muscle thickness for the deep abdominals as well as the GROC scores will be higher for those who receive the compression belt in addition to the lumbopelvic stabilization program as compared to those who receive the lumbopelvic stabilization alone.", - "NCTID": "NCT01559948" - }, - { - "brief_title": "PACIFIC: Providing Adults Collaborative Interventions For Ideal Changes", - "phase": "", - "drugs": "['Regulation of Cues (ROC)', 'Behavioral Weight Loss (BWL)', 'BWL + ROC', 'Nutrition Education, Stress Management and Social Support']", - "drugs_list": [ - "Regulation of Cues (ROC)", - "Behavioral Weight Loss (BWL)", - "BWL + ROC", - "Nutrition Education", - "Stress Management and Social Support" - ], - "diseases": "['Overweight', 'Obesity']", - "diseases_list": [ - "Overweight", - "Obesity" - ], - "enrollment": "271.0", - "inclusion_criteria": "All participants will be between the ages of 18-65 meeting criteria for overweight, with a BMI between 25 and 45. \n\n Participants will provide written informed consent for study participation. \n\n Participants will possess English language skills at the 5th grade reading level. \n\n Participants will be free of major medical conditions such as a recent history of coronary heart disease; recent history of myocardial infarction; recent symptoms of angina, diabetes, recent stroke, orthopedic problems that would limit activity during the following twelve months; or any other serious medical condition that would make physical activity unsafe. \n\n Participants will not have bulimia or anorexia, significant cognitive impairment, a known psychotic disorder, or unstable psychiatric illness (e.g., recent psychiatric hospitalization, acute suicidal ideation) as derived from their intake interview and questionnaires. \n\n Participants will not be moving out of the San Diego area for the duration of their study enrollment (24 months). \n\n Participants will not be pregnant, planning to get pregnant in the 2 year study period or lactating. \n\n Participants will not be taking medication for weight loss or that may impair physical activity tolerance or performance. \n\n Participants with medical or psychological problems, or taking medications that could make adherence with the study protocol difficult or dangerous will not be included. \n\n Participants cannot have a history of bariatric surgery \n\n Participants cannot currently be enrolled in an organized weight control program.", - "exclusion_criteria": "", - "brief_summary": "The objective of this proposed study is to collect initial efficacy data on ROC and ROC + BWL compared to an active comparator (AC) and to BWL.", - "NCTID": "NCT02516839" - }, - { - "brief_title": "Changes in Skin Conductance Measurement as an Endpoint Monitor for Sympathetic Blocks", - "phase": "", - "drugs": "['Lumbar Sympathetic Block', 'Skin conductance algesimeter']", - "drugs_list": [ - "Lumbar Sympathetic Block", - "Skin conductance algesimeter" - ], - "diseases": "['Nerve; Disorder, Sympathetic']", - "diseases_list": [ - "Nerve; Disorder", - "Sympathetic" - ], - "enrollment": "13.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients presenting for sympathetic block of the lower extremity (lumbar sympathetic block) \n\n Ages 18-99 \n\n ", - "exclusion_criteria": ": \n\n Patients with pacemakers or cardiac defibrillators \n\n Age <18 \n\n IV sedation for anxiolysis or analgesia \n\n Burn patients or patients with severe dermatologic conditions (as defined by skin conditions causing further pain to patients that actively has to be treated) \n\n Allergy to adhesive tape \n\n Patient with diagnosis of: Dysautonomia, Sympathetic dysfunction (e.g.,Raynaud disease, Buerger disease) or Disorders of sweating (e.g.,Acquired idiopathic generalized anhidrosis) \n\n Patients on vasoactive drugs", - "brief_summary": "This study is intended to evaluate a monitor that will facilitate ascertainment of an effective sympathetic blockade following Lumbar Sympathetic blocks. Utilization of a monitor with a rapid response and easy clinical applicability which can demonstrate effective sympathetic block would increase efficiency within the procedure suite and also serve to function as an objective endpoint for the evaluation of sympathetic blockade in future research.In current clinical practice, the most commonly used monitoring methods are clinical observations of sympathetic blockade, skin temperature monitoring, pulse pressure monitoring and any combination of these monitoring methods. The skin temperature and pulse pressure may increase after sympathetic block. However, changes in the skin temperature and pulse pressure often demonstrate an unpredictable or delayed response. Confounding variables, such as ambient temperature, coexisting vascular disease, use of other vasoactive medications may contribute to inconsistencies in the temperature or pulse pressure responses.~Normal sympathetic activity stimulates muscarinic receptors in the periphery that subsequently stimulate the sweat glands to secrete and fill with sweat containing sodium and other electrolytes. The electrolytes present in the sweat increase the electrical conductance while decreasing the electrical resistance at the skin level.~The real-time changes in skin conductance indices can be monitored at the skin level, by use of non-invasive electrodes attached to the skin (similar to EKG electrodes). A computer program analyzes the data and produces a real-time graphic and numeric data demonstrating the skin conductance response. The initiation of successful sympathetic blockade can cause rapid cessation of the skin sympathetic activity that leads to a decrease in skin conductance within seconds.", - "NCTID": "NCT02390323" - }, - { - "brief_title": "COugh Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop previoUs ACE-I Treatment Due to couGH in Poland", - "phase": "", - "drugs": "['Telmisartan (Kinzal/Pritor, BAY68-9291)']", - "drugs_list": [ - "Telmisartan (Kinzal/Pritor", - "BAY68-9291)" - ], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "2498.0", - "inclusion_criteria": "inclusion criteria: - hypertension \n\n age > 18 \n\n ACE-I related cough ", - "exclusion_criteria": ": - Current treatment with telmisartan \n\n Cholestatic disorders and severe hepatic failure \n\n Allergy to telmisartan \n\n Pregnancy and lactation period", - "brief_summary": "In the light of ONTARGET and TRANSCEND studies results, it would be interesting to investigate the real-life telmisartan treatment tolerability. It is well known and accepted that the Real-life setting is much more adequate to reflect the antihypertensive and safety properties of the drug in comparison to the organized and scheduled setting of the clinical trial. Because there are not much data on the cough in relation to telmisartan, therefore it would we worth to observe the cough frequency and general treatment tolerance in patients treated with telmisartan, who had to stop their previous ACE-I treatment due to cough.", - "NCTID": "NCT01211171" - }, - { - "brief_title": "REalWorld Insights on the INitiation and Treatment Duration of ticagrEloR & Other Oral Antiplatelets (OAP) in Patients With Acute Coronary Syndrome (ACS) in Be/Lux.", - "phase": "", - "drugs": "['ACS patients treated with OAP']", - "drugs_list": [ - "ACS patients treated with OAP" - ], - "diseases": "['Treatment of Acute Coronary Syndrome (ACS).']", - "diseases_list": [ - "Treatment of Acute Coronary Syndrome (ACS)." - ], - "enrollment": "430.0", - "inclusion_criteria": "inclusion criteria: \n\n The patient population that will be observed in the NIS must fulfil all of the following criteria: \n\n Female or male aged \u226518 years \n\n A patient information letter has been sent by the Investigator to the patient \n\n Patient discharged alive from this hospital to home following ACS (diagnosed with STEMI, NSTEMI or UA) \n\n ACS is either UA or myocardial infarction of Type 1 (spontaneous myocardial infarction related to ischemia due to a primary coronary event such as plaque erosion and/or rupture, fissuring, or dissection) \n\n ACS after 1st July 2012 and before 1st June 2013 \n\n Patient on ticagrelor, prasugrel or clopidogrel treatment at discharge following an ACS \n\n ", - "exclusion_criteria": ": \n\n Patients will not be eligible to participate if any of the following ", - "brief_summary": "REWINDER is a multinational, multicentre, non-interventional, retrospective study of patients treated with an oral antiplatelet (ticagrelor, prasugrel or clopidogrel) while in hospital after an acute coronary syndrome (ACS) event, to be conducted in Belgium and Luxembourg.~Primary objective is to evaluate the actual treatment persistence with oral antiplatelets (OAP) after an ACS in the clinical practice in Belgium and Luxembourg.~The main secondary objectives are to describe the most frequent reasons for OAP treatment switch, discontinuation or reinitiation; to identify the decisionmakers in the OAP treatment changes and to characterize the patient profile in terms of demographics, diagnosis, management strategies, comorbidities and concomitant medications to identify any association between patient profile and treatment duration.", - "NCTID": "NCT02190123" - }, - { - "brief_title": "Sildenafil for Treatment of Digital Ulcers in Patients With Systemic Sclerosis", - "phase": "Phase 2", - "drugs": "['Sildenafil therapy']", - "drugs_list": [ - "Sildenafil therapy" - ], - "diseases": "['Active Digital Ulcers']", - "diseases_list": [ - "Active Digital Ulcers" - ], - "enrollment": "17.0", - "inclusion_criteria": "inclusion criteria: \n\n Digital gangrene, ulcers in patients with severe secondary Raynaud's phenomenon \n\n Stable therapy with vasoactive drugs, such as calcium channel blockers, angiotensin inhibitors/AT II receptor antagonists or pentoxifyllin 4 weeks before and during the treatment with sildenafil. \n\n Unchanged immunosuppressive therapy 3 months before treatment with sildenafil \n\n No effect of prostacyclin treatment, contraindications for prostacyclins, or other reasons excluding this therapy \n\n ", - "exclusion_criteria": ": \n\n Therapy with iloprost during the last 4 weeks \n\n Sympathectomy during the last 4 weeks \n\n TIA, stroke, myocardial infarction during the last 6 months \n\n Instable angina pectoris \n\n Hemorrhagic diathesis, thrombocytic dysfunction, fibromuscular dysplasia \n\n Microangiopathic hemolytic anaemia \n\n Azotaemia \n\n Hypertonus not adjustable with diuretic, clonidine, ACE inhibitors/AT II antagonists, calcium channel blockers) \n\n Left ventricular ejection fraction< 20% \n\n Hypotonus < 80/40 mm Hg \n\n Positive pregnancy test \n\n History of cancer \n\n History of gastric/duodenic ulcers without endoscopic proof of complete healing \n\n Participation in other studies (currently or during the last 4 weeks) \n\n Abuse of alcohol or other drugs, smoker \n\n Cardiac failure, use of nitrates", - "brief_summary": "This is a pilot study analyzing the effect of sildenafil therapy on digital ulcers in systemic sclerosis. We want to analyze ulcer healing by measuring the size of digital ulcers and their count and analyze the effect of sildenafil on angiography.", - "NCTID": "NCT00624273" - }, - { - "brief_title": "Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin", - "phase": "", - "drugs": "['Carbetocin', 'Oxytocin']", - "drugs_list": [ - "Carbetocin", - "Oxytocin" - ], - "diseases": "['Pregnancy Related', 'Anaesthesia']", - "diseases_list": [ - "Pregnancy Related", - "Anaesthesia" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Viable, singleton pregnancy \u2265 37 weeks gestation undergoing EL LSCS. \n\n Low risk for post-partum hemorrhage, such as no proven abruptio placentae, placenta previa, multiple pregnancy, pre-eclampsia / gestational hypertension, previous PPH, obesity (based on BMI pre pregnancy which is \u2265 30 kg/m2), big baby. \n\n Ability to provide informed consent. \n\n ", - "exclusion_criteria": ": \n\n Emergency caesarean section \n\n Preterm Labour \n\n Grandmultipara \n\n Multiple Pregnancy \n\n Placenta Previa \n\n Previous PPH \n\n Maternal Obesity ( BMI pre pregnancy \u2265 30 kg/m2)) \n\n Have co-morbidity illness such as hypertension/pre-eclampsia, established cardiac diseases, history or evidence of liver, renal, vascular, or endocrine disease and bleeding disorder. \n\n Contraindication to carbetocin and oxytocin \n\n Language Barrier \n\n Women undergoing general anaesthesia \n\n Women who has abnormal baseline ECG that suggestive myocardial ischemia", - "brief_summary": "A double-blinded randomised control trial conducted in the Department of Obstetrics and Gynaecology of a tertiary hospital, Universiti Kebangsaan Malaysia Medical Centre (UKMMC) for two years duration from January 1st, 2012 till December 31st, 2013.~The aim of the study is to compare the haemodynamic and cardiovascular effects between intravenous carbetocin 100 \u03bcg and intravenous oxytocin 5 IU in women undergoing elective Lower Segment Caesarean Section (EL LSCS).~Study hypothesis: A single injection of carbetocin is haemodynamically and cardiovascularly safe and has similar efficacy in comparison to a single injection of oxytocin.", - "NCTID": "NCT01719952" - }, - { - "brief_title": "Low Back Pain Patient Education Evaluation", - "phase": "", - "drugs": "['Patient education evaluation']", - "drugs_list": [ - "Patient education evaluation" - ], - "diseases": "['Low Back Pain']", - "diseases_list": [ - "Low Back Pain" - ], - "enrollment": "580.0", - "inclusion_criteria": "inclusion criteria: \n\n Must live in the United States \n\n Must understand and write English \n\n Must have access to a computer with e-mail and expect to have this access for at least 3 years \n\n Must be 18 years old \n\n Must have seen a doctor for back pain at least once in the past year \n\n ", - "exclusion_criteria": ": \n\n Pregnancy \n\n Back surgery in the past 6 months \n\n Expectation of having back surgery in the next 6 months \n\n Back pain due to a car accident or other major injury within the last 6 months \n\n Back pain or sciatica due to systemic disease (inflammatory rheumatic diseases, tumor, or other) \n\n Major physical or mental health condition for which one is currently being treated that severely limits daily activities \n\n Terminal illness \n\n Receiving disability or workers compensation insurance payments for back pain or sciatica \n\n Presently involved in legal proceedings because of back pain or sciatica \n\n Difficulty with bladder or bowel control that began with back pain or sciatica \n\n No visits to a doctor in the past year for back pain or sciatica \n\n Numbness in crotch area that began with back pain or sciatica \n\n Age under 18", - "brief_summary": "Back pain is one of the most common of all symptoms. It is also a great cause of days lost from work and visits to health care providers. This study will develop and evaluate an approach to low back pain that allows subjects to talk with each other and with health professionals via an Internet discussion group. Results we will look at include health behaviors, such as exercise; health status, such as pain and disability; and health care use, such as number of visits to doctors and other health care providers. Anyone 18 years old or older who lives in the United States and has ongoing Internet access can take part in the study. All subjects must have back pain and meet the eligibility criteria listed below.", - "NCTID": "NCT00000408" - } - ], - "1": [ - { - "brief_title": "CT Calcium Scoring in Suspected Stable Angina", - "phase": "", - "drugs": "['CT calcium scoring']", - "drugs_list": [ - "CT calcium scoring" - ], - "diseases": "['Coronary Disease']", - "diseases_list": [ - "Coronary Disease" - ], - "enrollment": "705.0", - "inclusion_criteria": "inclusion criteria: \n\n non-acute chest pain \n\n those who underwent CT calcium scoring \n\n availability of all relevant risk factor information \n\n ", - "exclusion_criteria": ": \n\n previous coronary disease i.e., myocardial infarction or revascularization", - "brief_summary": "Patients with stable chest pain presenting to general practitioners in UK are routinely referred to the chest pain clinics in the hospitals. They are assessed by clinical history including risk factors, cardiovascular exam, resting ECG, chest x-ray, and exercise ECG. CT calcium scoring (CTCS) is a technique that is very sensitive in identifying and quantifying calcified atherosclerotic plaques. Recent guidance from the National Institute of Clinical Excellence (NICE, citation 1) proposes the use of CTCS in patients with stable chest pain who have low likelihood of coronary artery disease (CAD). They recommend that patients with low likelihood (10-30%) have a CTCS and if the score is 0, they can be considered to have non-cardiac chest pain. However, there is controversy regarding relationship of absent calcification with significant CAD and its prognostic value.~At our institution, we have been performing CTCS in this patient cohort since 2003. We plan to retrospectively review the usefulness in CTCS in patients with different likelihood for significant CAD, particularly in patients with absent calcium and compare with the traditional assessment. We also plan to follow-up these patients for any myocardial infarction and death from any cause.", - "NCTID": "NCT01660594" - }, - { - "brief_title": "A Prospective Pilot Study to Evaluate a New Marker of Ischemia in Chest Pain Triage", - "phase": "", - "drugs": "['blood samples']", - "drugs_list": [ - "blood samples" - ], - "diseases": "['Acute Coronary Syndrome']", - "diseases_list": [ - "Acute Coronary Syndrome" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject with compatible symptoms with an acute coronary syndrome, for at least 15 minutes and not older than 3 hours (eg discomfort, tightness or chest pain, pain radiating to the left arm or two arms, pain in the jaw, pain in the back / neck / stomach, breathlessness , cold sweats, nausea / vomiting , dizziness ) \n\n Man or woman, \n\n Patient Did not receive heparin or low molecular weight heparin (LMWH ) before the initial blood sample , \n\n Patient Agreeing to participate in the study and who signed an informed consent \n\n ", - "exclusion_criteria": ": \n\n Minor or major patient trust \n\n Patient Not having signed informed consent (refusal , physical or mental disability ... ) \n\n Patient Who received anticoagulation before carrying blood samples \n\n Patient With a progressive septic processes , neoplasia undergoing treatment, dialyzed kidney failure, a history of surgery or coronary angioplasty less than six months. \n\n Transplanted heart, renal or hepatic \n\n heart attack \n\n Subject Whose symptoms clearly eliminates acute coronary syndrome ( penetrating trauma, traumatic injury by crushing ... ) \n\n Patient Died between the time of inclusion and arrival in the cardiology intensive care ( SIC ) \n\n Patient Withdrawing consent under study", - "brief_summary": "A Single-center prospective pilot study enrolling chest pain patients. CD 26 measurement will be performed and compared to troponin \u00b5s for early triage of these patients. This novel biomarker of myocardial ischemia (CD26) will be measured at the time of first medical contact (T0) and after 30 min simultaneously o troponin Ic.~All patients aged over 18 years with chest pain which may be related to acute coronary syndrome requiring pre hospital medical contact through the Emergency Medical Service.", - "NCTID": "NCT02608255" - }, - { - "brief_title": "A Study of Stress Heart Imaging in Patients With Diabetes at Risk for Coronary Disease.", - "phase": "Phase 4", - "drugs": "['Technetium Tc99m Sestamibi']", - "drugs_list": [ - "Technetium Tc99m Sestamibi" - ], - "diseases": "['Diabetes']", - "diseases_list": [ - "Diabetes" - ], - "enrollment": "205.0", - "inclusion_criteria": "inclusion criteria: \n\n History of diabetes for at least 5 years, with a least 2 risk factors (i.e. hypertension, elevated cholesterol levels, history of or current smoker, obese, family history of heart disease) & atypical chest pain. \n\n ", - "exclusion_criteria": ": \n\n Typical chest pain being treated with medication, unable to exercise, previous confirmed heart disease", - "brief_summary": "The study is designed to see if stress heart imaging can be used as a screening exam in patients with diabetes and risk factors of developing of coronary artery disease and experiencing future cardiac events.", - "NCTID": "NCT00162344" - }, - { - "brief_title": "Evaluation of Integrated Cardiac Imaging in Ischemic Heart Disease", - "phase": "Phase 4", - "drugs": "['Non invasive cardiac imaging']", - "drugs_list": [ - "Non invasive cardiac imaging" - ], - "diseases": "['Ischemic Heart Disease']", - "diseases_list": [ - "Ischemic Heart Disease" - ], - "enrollment": "697.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with intermediate (>20%, <90%) risk of IHD based on age,gender,symptoms and exercise stress test results \n\n ", - "exclusion_criteria": ": \n\n Age < 30 Yrs or > 75 yrs \n\n Pregnancy (suspected or ascertained) \n\n LV Dysfunction (LVEF < 35% by Echo or other method) \n\n Low (< =20%) or high (>=90%) probability of CAD \n\n Acute Coronary Syndrome \n\n Prolonged (> 20 minutes) chest pain \n\n De novo or accelerated angina \n\n Hemodynamic or electrical instability \n\n Recent ST-T segment or T wave changes of ischemic nature \n\n Acute myocardial infarction with or without ST segment elevation \n\n Elevated serum cardiac markers of necrosis \n\n Known diagnosis of CAD \n\n Previously known myocardial infarction \n\n Previous PCI \n\n Previous CABG \n\n Persistent atrial fibrillation or advanced AV Block \n\n Asthma or chronic treatment with aminophylline \n\n Recent (<6 months) cerebral ischemic attack \n\n Known significant carotid stenosis or vascular aneurisms \n\n Asthma or chronic treatment with aminophylline \n\n Active cancer \n\n Severe hypertension. Patients cannot withdraw therapy for 12 hours. \n\n Congenital heart disease \n\n Significant valvular disease \n\n Cardiomyopathy (e.g. DCM, HCM, ARVC, Amyloidosis) \n\n Inability to provide an informed consent", - "brief_summary": "Main purpose of the study:~To comparatively assess the diagnostic performance of non invasive anatomical and functional imaging modalities to detect significant obstructive coronary artery disease as demonstrated at invasive coronary angiography and functional evaluation of coronary lesions (fractional flow reserve).", - "NCTID": "NCT00979199" - }, - { - "brief_title": "Acute Coronary Syndrome and Care-Seeking Delay: A Web Based Behavioral Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Acute Myocardial Infarction', 'Heart Attack', 'Acute Coronary Syndrome', 'Unstable Angina']", - "diseases_list": [ - "Acute Myocardial Infarction", - "Heart Attack", - "Acute Coronary Syndrome", - "Unstable Angina" - ], - "enrollment": "2381.0", - "inclusion_criteria": "inclusion criteria: Acute myocardial infarction, acute coronary syndrome, unstable angina, men & women, all races & ethnicities \n\n - \n\n ", - "exclusion_criteria": ": age < 21 years", - "brief_summary": "The primary aim of this study is to increase our understanding of care-seeking behavior surrounding heart attacks or acute coronary syndromes [ACS]. This study uses an internet based survey to ask individuals how they obtained medical care in the midst of a heart attack. At present, care-seeking delay among individuals stricken with a heart attack prevents them from obtaining the full therapeutic benefit of hospital based medical care in a timely manner to reduce the long term health consequences of a heart attack. By using a self-tailoring survey instrument the study attempts to take into consideration the complex social processes by which the individual and their family make decisions to seek medical care for symptoms of a heart attack. The study is designed to obtain a national sample of ACS care-seeking behavior in the United States.", - "NCTID": "NCT01407146" - }, - { - "brief_title": "Phase II Multi-Center Study of T89 to Treat Chronic Stable Angina", - "phase": "Phase 2", - "drugs": "['T89']", - "drugs_list": [ - "T89" - ], - "diseases": "['Angina Pectoris']", - "diseases_list": [ - "Angina Pectoris" - ], - "enrollment": "124.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient must be between the ages of 18 and 80 years. \n\n Females of childbearing potential must have a negative pregnancy test, not be breast feeding and established on a method of contraception that in the investigator's opinion is acceptable. Females must agree to remain on their established method of contraception through their participation in the study. \n\n Evidence of coronary artery disease that consists of a well-documented medical history (over 3 months prior to the enrollment) of myocardial infarction or significant coronary artery disease with noninvasive or angiographic confirmation. \n\n Symptoms that support the diagnosis of chronic angina and/or a history of an abnormal exercise response limited by angina and/or electrocardiograph (ECG) changes. \n\n Moderate angina pectoris (Class II or Class III, Grading of Angina Pectoris by the Canadian Cardiovascular Society Classification System) \n\n Naive patient or patient who's Total Exercise Duration (TED) is between 3 to 7 minutes in ETT on Standard Bruce Protocol, and the difference in TED must be no more than 15% between the two screen examinations on day -7 and day 0 \n\n All anti-angina regimen (except short-acting nitroglycerin, and one beta-blocker or calcium channel blocker), warfarin or other oral anticoagulants which were used prior to this initial visit can be discontinued. \n\n Patient must understand and be willing, able and likely to comply with all study procedures and restrictions and comprehends the verbal rating scales and diary cards. \n\n Patient must be able to give voluntary written informed consent. \n\n ", - "exclusion_criteria": ": \n\n With contraindication to perform treadmill Exercise Tolerance Test (ETT). \n\n Pre-exercise ST-segment depression of at least 1 mm in any lead, left bundle branch block, digoxin therapy, Left Ventricular Hypertrophy (LVH) and Wolff-Parkinson-White (WPW) syndrome or other factors that could interfere with exercise electrocardiograph interpretation. \n\n Clinically significant arrhythmias or atrioventricular conduction block greater than first degree. \n\n Clinically significant co-morbidities, including hepatic or renal dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, history of cerebral hemorrhage, or seizure disorders that required anticonvulsant medication. \n\n History of congestive heart failure, unstable angina, severe valvular disease, severe hypertension, severe anemia, suspected or known dissecting aneurysm, acute myocarditis or pericarditis, thrombophlebitis or pulmonary embolism or recent myocardial infarction within three months of study entry. \n\n History of bleeding diathesis, or is on warfarin. \n\n Implanted pacemaker. \n\n Aspirin and/or statins started less than 14 days prior to the signing of informed consent. \n\n Pregnancy or lactation. \n\n Inability to discontinue existing chronic nitrate regimen (e.g. long acting nitroglycerin) and allow only short-acting nitroglycerin and one beta-blocker or calcium channel blocker. \n\n Clinical trials/experimental medication: \n\n Participation in any other clinical trial or receipt of an investigational drug within 90 days prior to initial visit. \n\n Those patients unable, in the opinion of the investigator, to comply fully with the trial requirements. \n\n Previous participation in this study. \n\n Substance abuse. Patients with a recent history (within the last 2 years) of alcoholism or known drug dependence. \n\n Patient is a family member or relative of the study site staff.", - "brief_summary": "The purpose of this study is to determine the anti-angina effect and dose response of T89, a 2-herb botanical drug product, in patients with chronic stable angina pectoris in the United States.", - "NCTID": "NCT00797953" - }, - { - "brief_title": "Study to Assess Efficacy of Nicorandil+Atenolol vs Atenolol in Treatment of Chronic Stable Angina.", - "phase": "Phase 4", - "drugs": "['Nicorandil', 'Atenolol']", - "drugs_list": [ - "Nicorandil", - "Atenolol" - ], - "diseases": "['Chronic Stable Angina']", - "diseases_list": [ - "Chronic Stable Angina" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. \n\n Male and female \n\n Age 25 to 65 years \n\n Patient must understand and be willing, able and likely to comply with all study procedures and restrictions and comprehends the diary cards. \n\n Patient must be able to give voluntary written informed consent. \n\n ", - "exclusion_criteria": ": \n\n Hypertension of > 170/100 mm of Hg \n\n Valvular heart disease and cardiomyopathy \n\n Myocardial infarction in < 6 months \n\n Unstable angina \n\n Congestive cardiac failure \n\n Severe anemia (Hb 7G/dl) \n\n Cardiac arrhythmias or II or III degree AV block \n\n Significant liver or renal dysfunction \n\n IDDM (Type-1 diabetes mellitus) \n\n Systolic blood pressure < 100 mm Hg \n\n Pregnant and nursing women \n\n Known hypersensitivity to nicorandil \n\n On calcium channel blockers \n\n Patients not eligible for Tc 99m SPECT \n\n Patients in whom beta blockers are contraindicated \n\n Geographical inaccessibility for treatment or follow-up evaluations", - "brief_summary": "This study is to determine the anti-anginal and anti-ischemic effect of k-channel opener, nicorandil in patients of chronic stable angina.", - "NCTID": "NCT01397994" - }, - { - "brief_title": "The Renin-Angiotensin System in Essential Hypertension", - "phase": "", - "drugs": "['Enalapril 20 mg bd', 'Candesartan 8 mg bd']", - "drugs_list": [ - "Enalapril 20 mg bd", - "Candesartan 8 mg bd" - ], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "11.0", - "inclusion_criteria": "inclusion criteria: \n\n Essential Hypertension \n\n SBP 140-159 mmHg \n\n DBP 90-99 mmHg \n\n ", - "exclusion_criteria": ": \n\n Intolerance of or allergy to ACE Inhibitors or ARBS \n\n Pregnant or Breastfeeding \n\n Pre-menopausal women \n\n Uncontrolled cardiac or renal failure \n\n Diabetes mellitus", - "brief_summary": "Although ACE Inhibitors and Angiotensin Receptor Blockers are effective blood pressure lowering agents, the exact mechanisms by which these agents lower BP are still not fully understood. This study aims to compare the blood pressure and hormonal responses (plasma renin activity and aldosterone) to the ACE inhibitor enalapril and ARB candesartan in individuals with mild essential hypertension.", - "NCTID": "NCT00141583" - }, - { - "brief_title": "Treatment of Coronary Heart Disease With Amiloride", - "phase": "Phase 2; Phase 3", - "drugs": "['Amiloride', 'Nitrates, clopidogrel, aspirin, statins']", - "drugs_list": [ - "Amiloride", - "Nitrates", - "clopidogrel", - "aspirin", - "statins" - ], - "diseases": "['Coronary Heart Disease']", - "diseases_list": [ - "Coronary Heart Disease" - ], - "enrollment": "70.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female; age 35-75 years having angina (Canada Cardiovascular Society Class II-IV) \n\n Essential Hypertension defined as taking at least 1 anti-hypertensive medication, or average systolic blood pressure \u2265140 mm Hg, or diastolic blood pressure \u226590 mmHg \n\n ST-T changes of LVH (Romhilt-Estes or Framingham Heart Study criteria, with typical LV strain pattern, or isoelectric, inverted or biphasic T waves) \n\n ST-T changes of ischemia in resting ECG (ST depression, isoelectric, biphasic, negative or inverted T-waves) \n\n Serum potassium < 5.0 mmol/L prior to randomization \n\n Negative pregnancy test in child-bearing potential women \n\n Willing to comply with scheduled visits \n\n Informed consent form signed by the subject \n\n ", - "exclusion_criteria": ": \n\n Resistance hypertension despite 3-drugs treatment \n\n Myocardial infarction in past 90 days \n\n Coronary artery bypass graft surgery in past 90 days \n\n Atrial fibrillation with a resting heart rate > 90 bpm \n\n Percutaneous coronary intervention in past 30 days \n\n Implanted Pacemaker \n\n Stroke in past 90 days \n\n Left or Right Ventricular Branch Block \n\n Aldosterone antagonist or K sparing drug in last 7 days \n\n Intolerance to amiloride \n\n Lithium use \n\n Current participation in any other therapeutic trial \n\n Any condition that may prevent the subject from adhering to the trial protocol \n\n History of hyperkalemia (K \u22655.5 mmol/L) in the past six months or K >5.0 mmol/L within 2 weeks \n\n Chronic renal dysfunction \n\n Liver disease \n\n Chronic pulmonary disease \n\n Significant uncorrected valvular heart disease", - "brief_summary": "Treatment of coronary artery disease is a major health care problem across the entire word, and the United States. Unfortunately, despite a number of medical advances, diagnostic procedure, or epidemiological studies, the treatment of these patients remain complex, and and at times frustrating. In fact, the COURAGE trial conducted in 50 centers across United States and Canada documented that drug treatment, coronary interventions or both were not effective solution in coronary artery diseases.~A novel approach has recently been developed, based on the critical role of the potassium (K) content in red-blood-cell in myocardial oxygenation, since oxygen and K binding by hemoglobin (red-blood-cell) occurs simultaneously in blood passing through the lungs, whereas in the organs as the heart, the hemoglobin release both Oxygen and K ions.~This apparently simple mechanisms occurs in human blood in all individuals but could be altered in subjects with acquired or hereditable defect in red-blood-cell K content. The purpose of this trial, thus, will be to evaluate the pharmacological effects of Amiloride on RBC K-uptake and transport and its impact on reversion of angina, electrocardiographic changes of myocardial ischemia and electrical regeneration of the heart in subjects with coronary artery diseases.", - "NCTID": "NCT01231165" - }, - { - "brief_title": "Rosiglitazone Versus Placebo in Chronic Stable Angina", - "phase": "Phase 4", - "drugs": "['Rosiglitazone']", - "drugs_list": [ - "Rosiglitazone" - ], - "diseases": "['Angina Pectoris', 'Metabolic Syndrome X']", - "diseases_list": [ - "Angina Pectoris", - "Metabolic Syndrome X" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n Chronic stable angina - to see if this improves \n\n Previous positive exercise tolerance test - to ensure that repeating it yields a result \n\n Disease not suitable for coronary intervention (Coronary artery bypass grafting or angioplasty) - so that best routine care is not withheld \n\n Do not have overt diabetes - work on this is being undertaken elsewhere \n\n Body mass index (BMI) greater than 25 \n\n ", - "exclusion_criteria": ": \n\n Diabetes mellitus - see above \n\n Liver failure (ALT>70U/l, AST>80U/l) \n\n Renal failure (creatinine > 130mmol/l) \n\n Cardiac failure - rosiglitazone is contraindicated in those with NYHA 3 and 4 cardiac failure \n\n Physical disability - if it precludes treadmill testing \n\n Women of child bearing capacity \n\n Breast feeding mothers", - "brief_summary": "We wish to see if the drug rosiglitazone, currently used in the treatment of type 2 diabetes, could be used as a new treatment for angina when compared with placebo in overweight subjects who do not have overt diabetes. The drug will be given for 3 months and the subjects will be have their angina tested, by way of exercise testing, angina quality of life questionnaire and 24-hour ECG monitoring before and after using the drug.", - "NCTID": "NCT00225355" - }, - { - "brief_title": "Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation", - "phase": "Phase 4", - "drugs": "['Diltiazem treated group', 'Bisoprolol treated group', 'Candesartan treated group']", - "drugs_list": [ - "Diltiazem treated group", - "Bisoprolol treated group", - "Candesartan treated group" - ], - "diseases": "['Stable Angina']", - "diseases_list": [ - "Stable Angina" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Stable angina patients whose coronary lesions is confirmed by angiography or receives PCI \n\n Unstable Angina/NSTEMI patients who completed PCI for main lesions \n\n Either systolic > 130mmHg or diastolic > 80mmHg, or patients with anti-hypertensive drugs \n\n ", - "exclusion_criteria": ": \n\n STEMI patients within one month \n\n Variant Angina \n\n Liver function abnormality or renal failure \n\n History of Hypersensitivity to testing drugs \n\n Severe heart failure(NYHA class>3) or uncorrectable hematologic disease \n\n Woman possible to be pregnant \n\n Uncontrolled diabetes \n\n Expected life span < one year", - "brief_summary": "Treatments for stable angina includes drug therapy such as calcium-channel blocker, beta blocker, and ACEI/ARB. To obtain good prognosis in patients with coronary artery disease,preventing or correcting the progression of atherosclerosis and dyslipidemia is more important than relieving angina symptom. Dysfunction of microvessel is one of the most important factor in patients with coronary artery disease. Recently, we developed the new non-invasive method of evaluating the microvessel in fundus. With this methods, we will compare the effect of each drug (beta blocker, CCB, ARB).", - "NCTID": "NCT01162902" - }, - { - "brief_title": "Early Invasive Versus Conservative Therapy in Women With an Acute Coronary Syndrome", - "phase": "", - "drugs": "['coronary angiography', 'adenosine stress test']", - "drugs_list": [ - "coronary angiography", - "adenosine stress test" - ], - "diseases": "['Acute Coronary Syndrome']", - "diseases_list": [ - "Acute Coronary Syndrome" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Women age 18 years or older \n\n Non-ST-elevation acute coronary syndrome (defined as new onset chest discomfort that occurs at rest or with low levels of activity/or emotion within the preceding 48 hours) with either: \n\n elevated troponin T (\u2265 0.03 ng per milliliter), \n\n elevated creatinine kinase MB-isoenzyme (\u2265 5.0 ng per milliliter) \n\n elevated NT-pro-BNP (\u2265 450 pg per milliliter), \n\n ST-segment depression (\u2265 0.5 mm) \n\n or TIMI risk score (> 2) \n\n women who have elevated cardiac enzymes after non-cardiac surgery will also be considered. \n\n ", - "exclusion_criteria": ": \n\n ST-elevation myocardial infarction, \n\n cardiogenic shock, \n\n congestive heart failure, \n\n hemodynamic instability, \n\n use of fibrinolytic therapy in the last 96 hours, \n\n current bleeding or bleeding disorder within the last 3 months that required transfusion, \n\n pregnancy, \n\n contraindication to any study medication. i.e.heparin, clopidogrel, or glycoprotein IIb/III inhibitor, \n\n PCI in the last 6 months, \n\n prior CABG, \n\n inability to provide written informed consent.", - "brief_summary": "The aim of this research is to evaluate the effect of early invasive therapy and appropriate revascularization compared with conservative management and selective revascularization among women with an acute coronary syndrome.", - "NCTID": "NCT02357212" - }, - { - "brief_title": "Add-on Effects of Valsartan on Morbi- Mortality (KYOTO HEART Study)", - "phase": "Phase 4", - "drugs": "['Valsartan', 'Non-ARB']", - "drugs_list": [ - "Valsartan", - "Non-ARB" - ], - "diseases": "['Hypertension', 'Ischemic Heart Disease', 'Congestive Heart Failure', 'Stroke']", - "diseases_list": [ - "Hypertension", - "Ischemic Heart Disease", - "Congestive Heart Failure", - "Stroke" - ], - "enrollment": "3031.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of hypertension \n\n Clinical diagnosis of one or more risk factors, such as diabetes, smoking habit, lipid metabolism abnormality, history of ischemic heart disease (IHD) or cerebrovascular disease, obesity (BMI>25), chronic heart failure (NYHA II-III), and electrocardiogram (ECG) abnormality (LVH) \n\n ", - "exclusion_criteria": ": \n\n Patients who have already been administered ARB \n\n Patients with IHD within 6 months after percutaneous coronary intervention(PCI), and who are stable but are going to implement PCI or coronary artery bypass grafting(CABG) \n\n Severe/malignant/secondary hypertensive patients \n\n Pregnant women and women of childbearing potential \n\n History of heart failure, unstable angina, myocardial infarction, PTCA, or CABG within the preceding 6 months \n\n Arrhythmia needed to be treated or accompanied with symptoms, second or third degree AV block \n\n Severe renal impairment (Serum creatinine >3.0 mg/dl) \n\n Severe hepatic impairment (Hepatic failure, Cirrhosis, etc.)", - "brief_summary": "The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients in Japan with hypertension in terms of the morbidity and mortality.", - "NCTID": "NCT00149227" - }, - { - "brief_title": "A Multicenter Study to Evaluate the ROX Anastomotic Coupler System (ACS) In Patients With Severe Hypertension", - "phase": "Phase 2", - "drugs": "['ROX ANASTOMOTIC COUPLER SYSTEM (ACS)', 'ROX Anastomotic Coupler System (ACS)']", - "drugs_list": [ - "ROX ANASTOMOTIC COUPLER SYSTEM (ACS)", - "ROX Anastomotic Coupler System (ACS)" - ], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "8.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of severe hypertension must be made on the basis of current findings, medical history, and physical examination \n\n ", - "exclusion_criteria": ": \n\n Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.", - "brief_summary": "The purpose of this study is to evaluate the safety and performance of the ROX Anastomotic Coupler System (ACS) in patients with severe hypertension.", - "NCTID": "NCT01682057" - }, - { - "brief_title": "Prospective Cohort Study of the Effect of Bariatric/Metabolic Surgery on Morbid Obesity Patients With Metabolic Syndrome", - "phase": "", - "drugs": "['Bariatric surgery', 'Intensive medical therapy']", - "drugs_list": [ - "Bariatric surgery", - "Intensive medical therapy" - ], - "diseases": "['Obesity', 'Metabolic Syndrome']", - "diseases_list": [ - "Obesity", - "Metabolic Syndrome" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Morbid obesity (BMI>30) patients with one of comorbidity (type 2 diabetes, dyslipidemia, or hypertension) \n\n Morbid obese patients (BMI>35) \n\n ", - "exclusion_criteria": ": \n\n Prior bariatric surgery \n\n Malignancy (any type) \n\n End stage renal disease", - "brief_summary": "The purpose of this study is to determine the change in kidney function and blood pressure after gastric bypass versus conventional medical therapy in morbid obesity. The study mainly focus on glomerular filtration rate(GFR) with known relation to the renal function and 24 hours ambulatory blood pressure monitoring after intervention of gastric bypass or medical treatment.", - "NCTID": "NCT02271568" - }, - { - "brief_title": "PCI and Renal Denervation in Hypertensive Patients With Acute Coronary Syndromes", - "phase": "Phase 2", - "drugs": "['Renal denervation']", - "drugs_list": [ - "Renal denervation" - ], - "diseases": "['Hypertension', 'Acute Myocardial Infarction']", - "diseases_list": [ - "Hypertension", - "Acute Myocardial Infarction" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Provision of informed consent prior to any study specific procedures \n\n Female and/or male aged 18-80 years \n\n Patients with ACS, i.e. STEMI, non-STEMI, treated with PCI \n\n Medical history of treated (ongoing) hypertension, or hypertension discovered at the time of ACS, and office SBP >140 despite treatment with three antihypertensive drugs. \n\n Ejection fraction >40%. \n\n ", - "exclusion_criteria": ": \n\n Increased risk of pathological bleedings \n\n Office systolic blood pressure <120 \n\n Renal artery abnormalities. \n\n eGFR <30 mL/min \n\n ICD or pacemaker, or any other metallic implant not compatible with MRI \n\n Estimated survival time <1 year \n\n Not oriented to person, place and time \n\n Inability to understand given information about the study \n\n Fertile female", - "brief_summary": "Research hypothesis:~Is the treatment with renal denervation (RDN) early post ACS safe and effective and does it leads to improved cardiac function and attenuation of pathologic left ventricular remodelling? In a following study, the hypothesis will be tested in a larger ACS population with major adverse cardiovascular events (MACE) after ACS as the endpoint.~Rationale for conducting this study:~ACS i.e. ST-elevation myocardial infarction (STEMI) and non- ST-elevation myocardial infarction (non-STEMI) are the most important causes of morbidity and mortality in western societies. Hypertension is a major risk factor for development of ACS and heart failure but it also worsens the prognosis in patients after ACS. Our research highlights the combination therapy of PCI and RDN in an ACS patient population with simultaneous hypertension.~Primary objective:~The primary objective of this study is to establish safety and efficacy of combined treatment with PCI and renal denervation (RDN) in hypertensive patients with acute coronary syndromes (STEMI and non-STEMI ) having ventricular mass after 4 months as the primary variable.~Endpoints:~The primary end point is change in left ventricular mass (LVM) at 4 months evaluated by magnetic resonance imaging (MRI).~Secondary endpoints:, blood pressure (office and 24-h ABPM), and left ventricular volumes and ejection fraction.", - "NCTID": "NCT02272920" - }, - { - "brief_title": "The ACE Follow-up Study", - "phase": "", - "drugs": "['ACE Stapler']", - "drugs_list": [ - "ACE Stapler" - ], - "diseases": "['Obesity']", - "diseases_list": [ - "Obesity" - ], - "enrollment": "69.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject, male or female, is age 18 to 50 years of age. \n\n Subject must be able to understand and be willing to sign an informed consent document. \n\n Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits. \n\n Subject has a BMI of 40 - 45 or 30 to 39.9 plus one or more co-morbid diseases expected to improve with weight loss, including but not limited to hypertension, dyslipidemia, obstructive sleep apnea, or diabetes mellitus. \n\n Subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair. \n\n Subject must be of sufficient and stable medical health, as evaluated by the Principal Investigator. \n\n Subject must have a primary care physician that will manage the subject for any co-morbid conditions throughout the study. \n\n Subject must have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination, as assessed by an interview with a member of the study team at baseline. \n\n Subject agrees to refrain from any type of reconstructive surgery that may affect body weight such as mammoplasty or abdominal lipoplasty or liposuction, during the trial. \n\n ", - "exclusion_criteria": ": \n\n Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease. \n\n Subject has poorly controlled diabetes as indicated by the lack of stable diabetes medications and doses over the last month, or has a history of diabetes for greater than 10 years. \n\n Subject has had significant weight loss in the last 3 months, or between baseline and the study procedure. \n\n Subject has a history or is diagnosed with eating disorders. \n\n Subject has history of peptic ulcer and tests positive for H. pylori, unless treated before the procedure. \n\n Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease. \n\n Subject has pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer. \n\n Subject has significant esophageal disease including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility. \n\n Subject is observed during EGD to have heavily scarred, malignant or poor quality/friable tissue in areas of the stomach where plications are to be placed.", - "brief_summary": "The Articulating Circular Endoscopic (ACE) Stapler is an investigational system using endoscopic guidance to trans-orally place plications in the stomach in obese subjects to reduce volume and expansion of the fundus and greater curve to abate hunger as part of a supervised weight reduction program.~The primary objective of this study is to perform an evaluation of the safety of the plication procedure.~The secondary objective of this study is to evaluate the preliminary efficacy of the ACE Stapler for the treatment of obesity over a 24 month follow-up period.", - "NCTID": "NCT01429194" - }, - { - "brief_title": "Blood Pressure Interaction Between Sildenafil and Sublingual Glyceryl Trinitrate (GTN) in Men With Angina", - "phase": "Phase 4", - "drugs": "['Sildenafil citrate', 'Glyceryl trinitrate']", - "drugs_list": [ - "Sildenafil citrate", - "Glyceryl trinitrate" - ], - "diseases": "['Angina Pectoris']", - "diseases_list": [ - "Angina Pectoris" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Male \n\n Stable angina with one of: \n\n Classical history of exertional angina pectoris \n\n Previous diagnostic exercise test \n\n Angiographic evidence of CAD \n\n Aged 30 to 80 years \n\n Weight between 60 and 100 Kg \n\n ", - "exclusion_criteria": ": \n\n Regular treatment with long-acting nitrates or nicorandil where these cannot be withdrawn 72 hours prior to the study \n\n Myocardial infarction, unstable angina, stroke or transient cerebral ischaemia within 3 months \n\n Systolic BP > 170 mmHg or diastolic BP > 100 mmHg \n\n Systolic BP < 100 mmHg or diastolic BP < 60 mmHg \n\n Orthostatic hypotension (> 20 mmHg fall in systolic BP on standing) \n\n Diabetes treated with oral hypoglycaemic agents or insulin \n\n Any clinically significant disease other than stable angina, excepting other cardiovascular disease risk factors, e.g. smoking, hypercholesterolaemia and diet-controlled diabetes \n\n Taking any drug that interacts with sildenafil \n\n Evidence of drug abuse", - "brief_summary": "The purpose of the study is to determine for how long sildenafil potentiates the blood pressure reduction that occurs with glyceryl trinitrate in men with angina.", - "NCTID": "NCT00479908" - }, - { - "brief_title": "REal World Information on Cardiovascular Drug Management Patterns in Acute Coronary Syndrome paTients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Acute Coronary Syndrome']", - "diseases_list": [ - "Acute Coronary Syndrome" - ], - "enrollment": "814.0", - "inclusion_criteria": "inclusion criteria: \n\n Provision of subject informed consent \n\n Patients hospitalized and diagnosed with STEMI or NSTEMI \n\n Hospitalized within 24 hours of onset of symptoms or transferred from another hospital within 24 hours of the onset of symptoms \n\n ", - "exclusion_criteria": ": \n\n STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or GI bleeding or post-PCI. \n\n STEMI and NSTEMI occurring in patients already hospitalized for other reasons. \n\n Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances).", - "brief_summary": "RE-ACT is a national, multi-centre, observational, prospective, longitudinal cohort study which will include patients hospitalized for ACS within 24 hours of symptom onset and who have a final diagnosis of ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI). This study aims to describe the short-term (at the end of the first month after index event) antithrombotic management patterns in a real-life setting for patients hospitalized with an acute coronary syndrome.", - "NCTID": "NCT02001545" - }, - { - "brief_title": "The ACS Ethnicity Platelet Function Study", - "phase": "", - "drugs": "['Ticagrelor']", - "drugs_list": [ - "Ticagrelor" - ], - "diseases": "['Acute Coronary Syndrome']", - "diseases_list": [ - "Acute Coronary Syndrome" - ], - "enrollment": "4.0", - "inclusion_criteria": "inclusion criteria: \n\n Female (post menopausal or surgically sterile) and/or male aged 18 years or older \n\n Presenting with ACS fulfilling the following: \n\n Symptoms or new ECG changes (ST segment elevation or depression of at least 1 mm in 2 or more contiguous leads on EKG) \n\n Elevation of biomarkers (CK-MB \u22652 ULN or troponin \u2265 ULN) \n\n Self-identified as African-American \n\n Treatment with 75-100mg ASA daily \n\n ", - "exclusion_criteria": ": \n\n Any indication (atrial fibrillation, mitral stenosis or prosthetic heart valve, PE, DVT) for antithrombotic treatment during study period. \n\n Fibrinolytic therapy within 48 hours before randomization \n\n Concomitant therapy with a drug having possible interaction with ticagrelor. (concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer) \n\n Increased bleeding risk including: recent (<30 days) GI bleeding, any history of intracranial, intraocular, retroperitoneal, or spinal bleeding, recent (<30 days of dosing) major trauma, sustained uncontrolled hypertension (systolic blood pressure [SBP]>180mmHg or diastolic blood pressure [DBP]>100mmHg), history of hemorrhagic disorders that can increase the risk of bleeding, platelet count less than 100,000 mm3 or hemoglobin <10 g/dL. \n\n Any history of hemorrhagic stroke. \n\n Contraindication or other reason that ASA or ticagrelor should not be administered (e.g., hypersensitivity, active bleeding, major surgery within 30 days of dosing). \n\n Severe renal failure (creatinine clearance <30mL/min or patient requires dialysis) \n\n History of moderate or severe hepatic impairment with aspartate amino transferace, alanine amino transferase or total bilirubin > 1.5 x upper limit of the reference range. \n\n Pregnant or lactating women. \n\n Patients receiving any glycoprotein IIb/IIIa inhibitors <8 hours before platelet reactivity testing.", - "brief_summary": "This study is being done to assess the effects of the CTP inhibitor on the function of your platelets (cells within your blood that are involved in the formation of blood clots) and to assess whether you have responded to the ticagrelor well enough to prevent the formation of blood clots within the stent or site in which angioplasty was performed.~Recent studies have looked at how racial differences can affect platelet reactivity, the way blood clots. But these studies have not looked at the way different racial backgrounds can affect the way the blood forms clots. Minorities, such as African-Americans are underrepresented. Therefore, we are conducting this platelet reactivity study to better understand if there are differences in how this drug affects African-Americans from how they affect Caucasian patients undergoing percutaneous coronary intervention and receiving ticagrelor. These data will be compared to a historical control of Caucasian patients who underwent similar platelet function testing.", - "NCTID": "NCT01829659" - }, - { - "brief_title": "Effect of Amlodipine on Anti-platelet Drug Effect in Patients With Coronary Artery Disease", - "phase": "Phase 4", - "drugs": "['Amlodipine', 'Amlodipine']", - "drugs_list": [ - "Amlodipine", - "Amlodipine" - ], - "diseases": "['Ischemic Heart Disease']", - "diseases_list": [ - "Ischemic Heart Disease" - ], - "enrollment": "97.0", - "inclusion_criteria": "inclusion criteria: \n\n ischemic heart disease patient, and \n\n given loading or maintenance dose of clopidogrel and in need of it for 1 or more month \n\n and in need of additional drug for optimal BP control (aim blood pressure <130/90) or angina control. \n\n ", - "exclusion_criteria": ": \n\n existing use of amlodipine \n\n thrombocytopenia \n\n end stage renal failure \n\n allergy to clopidogrel/ amlodipine \n\n pregnancy/ lactation \n\n strong inhibitor or inducer of cytochrome P450 3A4 enzyme within 7 days before start of the study.", - "brief_summary": "Clopidogrel can reduce risk of cardiovascular disease by inhibiting platelet aggregation. It is metabolized to an active drug by a liver enzyme. Its efficacy may be measured by blood sampling for platelet activity, analyzed by VerifyNow device. Calcium Channel blocker (CCB) is also commonly used for blood pressure and anginal control in these patients. Dihydropyridine group of calcium channel blocker (e.g. amlodipine) inhibits this enzyme. There are observational studies reporting dihydropyridine CCB reducing clopidogrel effect, but the clinical implication is unclear.~This study test the hypothesis that there is no significant effect of dihydropyridines CCB on clopidogrel response compared with control. After giving consent, patients with suboptimal blood pressure or anginal control will be randomized to receive either dihydropyridine CCB or non-CCB as placebo. These patient will be follow-up in 1 month.", - "NCTID": "NCT01203696" - }, - { - "brief_title": "Diet and Prevention of Ischemic Heart Disease: a Translational Approach", - "phase": "", - "drugs": "['DIPI']", - "drugs_list": [ - "DIPI" - ], - "diseases": "['Ischemic Heart Disease']", - "diseases_list": [ - "Ischemic Heart Disease" - ], - "enrollment": "222.0", - "inclusion_criteria": "inclusion criteria: \n\n healthy men and women aged 30 to 65 years who has one or more self-assessed ischemic heart disease risk factors at screening: physical inactivity, overweight or obese (BMI \u2265 25/m2 ), waist circumference (\u2265 80 cm for women, \u2265 94 cm for men). In addition, the participants should have the motivation and willingness to be randomized to any of the three groups, and to do their best to follow the given protocol . \n\n ", - "exclusion_criteria": ": \n\n no internet access or no access to a computer, smoking, pregnancy, or breast-feeding or planning to become pregnant within the next 12 months, a history of cardiovascular disease, type 2 diabetes, chronic disease / disorders that may affect the results of the study, substance abuse within the past 12 months, regular alcohol consumption > 21 units / week for men or > 14 units/ week for women, allergy or intolerance to food groups in the dietary guidelines, supplements with mega doses of nutrients that can have potential impact on ischemic heart disease risk markers (eg . fish oils).", - "brief_summary": "The objective of this study is to test the effect of substitution dietary guidelines that are specifically aimed at the prevention of ischemic heart disease (IHD) on the dietary intake in the general Danish population.", - "NCTID": "NCT02062424" - }, - { - "brief_title": "Pharmacodynamic Study of Carvedilol Versus Metoprolol in Heart Failure", - "phase": "Phase 4", - "drugs": "['Terbutaline Infusion']", - "drugs_list": [ - "Terbutaline Infusion" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients eligible for the study had objective evidence of systolic dysfunction (ejection fraction \u226440%), were >18 years of age, and were on stable optimal medical heart failure therapy excluding the use of beta-blockers within the previous 30 days. \n\n ", - "exclusion_criteria": ": \n\n . Patients were excluded for active viral myocarditis; hemodynamically significant valvular heart disease; hypertrophic cardiomyopathy, peripartum cardiomyopathy; contra-indications to beta-blockers (asthma or obstructive airway disease requiring scheduled bronchodilators or inhaled steroids), resting heart rate <55; supine blood pressure <85/50; second or third degree heart block); concomitant use of beta-agonists, beta-antagonists, or anti-arrhythmics; unstable angina; myocardial infarction or bypass surgery within 3 months; or significant renal insufficiency (creatinine >2.5 mg/dL), liver disease (transaminase levels > 3 fold above laboratory normal), or anemia.", - "brief_summary": "Metoprolol succinate is a beta1-selective beta-blocker, becoming non-selective at higher doses, while carvedilol is non-selective. We examined whether metoprolol remained beta1-selective compared to carvedilol during dose up-titration in Class C heart failure (HF) Beta-blocker na\u00efve patients.~METHODS: Twenty-five NYHA FC II-III HF patients were randomized to carvedilol or metoprolol. Patients were studied at baseline and after 2 weeks of up-titration (metoprolol at 25, 50, 100, and 200 mg daily; carvedilol IR at 3.125, 6.25, 12.5, 25 mg and 50mg twice daily). Beta2- blockade was determined by an infusion of terbutaline at 6 mg/kg over 1 hour. Glucose and potassium levels were serially measured at baseline, every 15 minutes for the 1st hour and 30 minutes for 2nd hour post-infusion. The median area under the curve (AUC) for glucose and potassium changes were calculated.", - "NCTID": "NCT00802230" - }, - { - "brief_title": "Protein Supplementation and Weight Loss", - "phase": "", - "drugs": "['herbalife protein shake']", - "drugs_list": [ - "herbalife protein shake" - ], - "diseases": "['Obesity']", - "diseases_list": [ - "Obesity" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects aged between 21 -65 years \n\n Subjects with BMI > 23 Kg/m2 \n\n ", - "exclusion_criteria": ": \n\n inclusion criteria: \n\n Subjects aged between 21 -65 years \n\n Subjects with BMI > 23 Kg/m2 \n\n ", - "brief_summary": "This randomized control trial of diet with protein supplementation is being conducted to test the hypothesis that in overweight/obese subjects high protein diet may lead to weight loss and improvement in cardio-metabolic profile.", - "NCTID": "NCT02144636" - }, - { - "brief_title": "Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance", - "phase": "Phase 4", - "drugs": "['Valsartan', 'Amlodipine']", - "drugs_list": [ - "Valsartan", - "Amlodipine" - ], - "diseases": "['Hypertension', 'Type 2 Diabetes Mellitus']", - "diseases_list": [ - "Hypertension", - "Type 2 Diabetes Mellitus" - ], - "enrollment": "1150.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of hypertension \n\n Clinical diagnosis of type 2 diabetes or impaired glucose tolerance \n\n ", - "exclusion_criteria": ": \n\n History of congestive heart failure, myocardial infarction, or coronary revascularization in the recent 6 months. \n\n Taking calcium channel blocker for the purpose of angina pectoris \n\n Reduced ejection fraction (< 40%) \n\n Second- or third-degree of atrioventricular block \n\n Severe hypertension (> 200/110 mmHg) or secondary hypertension \n\n History of stroke in the recent 6 months \n\n Serum creatinine > 2.5 mg/dl \n\n Estimated survival duration less than 3 years due to other conditions \n\n Pregnant woman or possibly pregnant woman", - "brief_summary": "Various guidelines recommended angiotensin converting enzyme (ACE) inhibitors or angiotensin \u2161 receptor-1 blockers (ARBs) for hypertensive patients with diabetes on the basis of the cardiac- and reno-protective effects of these drugs. However, these recommendations could not be extrapolated to Japanese patients, because Japan has been known as a country with a low incidence of coronary artery disease and a high incidence of cerebrovascular disease. Furthermore, calcium channel blockers (CCBs) also were protective against renal function as well as ACE inhibitors in Japanese diabetic hypertensive patients. This study will test whether ARBs or CCBs are superior in treating Japanese diabetic hypertensive patients.", - "NCTID": "NCT00129233" - }, - { - "brief_title": "Beta-Blocker Heart Attack Trial (BHAT)", - "phase": "Phase 3", - "drugs": "['propranolol']", - "drugs_list": [ - "propranolol" - ], - "diseases": "['Arrhythmia', 'Cardiovascular Diseases', 'Coronary Disease', 'Death, Sudden, Cardiac', 'Heart Diseases', 'Myocardial Infarction', 'Myocardial Ischemia', 'Ventricular Fibrillation']", - "diseases_list": [ - "Arrhythmia", - "Cardiovascular Diseases", - "Coronary Disease", - "Death", - "Sudden", - "Cardiac", - "Heart Diseases", - "Myocardial Infarction", - "Myocardial Ischemia", - "Ventricular Fibrillation" - ], - "enrollment": "", - "inclusion_criteria": "Men and women, ages 30 to 69. Documented myocardial infarction.", - "exclusion_criteria": "", - "brief_summary": "To determine whether the regular administration of the beta-blocker drug propranolol to people who had had at least one documented myocardial infarction would result in a significant reduction of mortality from all causes over the follow-up period. Eligible volunteer patients were recruited to participate in a double-blind clinical trial within 21 days after the onset of the acute event. One-half of the patients were randomly assigned to a beta-blocking drug (propranolol) and one-half to a placebo. The trial also evaluated the effect of propranolol on incidences of coronary heart disease mortality, sudden cardiac death, and nonfatal myocardial infarction plus coronary heart disease mortality in persons with documented previous myocardial infarction.", - "NCTID": "NCT00000492" - }, - { - "brief_title": "Prevalence and Outcome of Brachial Artery Endothelial Function in Morbidly Obese Patients Undergoing Bariatric Surgery", - "phase": "", - "drugs": "['Measurement of flow mediated dilation of brachial artery.']", - "drugs_list": [ - "Measurement of flow mediated dilation of brachial artery." - ], - "diseases": "['Obesity, Morbid', 'Ischemic Heart Disease']", - "diseases_list": [ - "Obesity", - "Morbid", - "Ischemic Heart Disease" - ], - "enrollment": "13.0", - "inclusion_criteria": "inclusion criteria: \n\n Morbidly obese patients who fulfill the NIH criteria for surgical intervention. \n\n ", - "exclusion_criteria": ": \n\n Patients deemed unfit for surgery \n\n Pregnant women, or who are attempting conception. \n\n Subjects with any history of myocardial infarction, coronary artery bypass grafting surgery, coronary angiography with angioplasty and/or stenting, or any lesion > 50% of the coronary artery luminal diameter, cerebrovascular accident, or peripheral vascular disease with abnormal electrocardiograms and/or echocardiography. \n\n History of drug or alcohol abuse. \n\n Chronic liver disease.", - "brief_summary": "The relation between obesity and ischemic heart disease (IHD) is under considerable debate. The reduction in all-cause mortality and, more specifically, the reduction in cardiac-related mortality seen after weight-loss surgery, may be due to regression or slowing developement of subclinical IHD. Function of cells lining the arteries (endothelium) is closely related to the state of IHD and its measurement can serve as a surrogate marker for the existence and severity of IHD. The investigators hypothesize that the prevalence of undiagnosed IHD in the morbidly obese population is high and that following surgery for weight reduction there is a halt in the progression, or even a regression in its severity.~The study includes measurement of endothelial function before and after weight-reducing surgery.", - "NCTID": "NCT00808652" - } - ], - "2": [ - { - "brief_title": "Non-cardiac Chest Pain Evaluation and Treatment Study (CARPA) - Part 1: Diagnosis.", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Non-Cardiac Chest Pain', 'Undiagnosed Chest Pain', 'Musculoskeletal Chest Pain', 'Ischemic Heart Disease']", - "diseases_list": [ - "Non-Cardiac Chest Pain", - "Undiagnosed Chest Pain", - "Musculoskeletal Chest Pain", - "Ischemic Heart Disease" - ], - "enrollment": "302.0", - "inclusion_criteria": "inclusion criteria: \n\n Acute episode of chest pain of less than 7 days duration as primary reason for admission to a chest pain clinic. \n\n Admitted to a chest pain clinic, suspected of acute coronary infarction, but with a negative diagnosis confirmed by normal coronary enzymes and normal ECG. \n\n Pain arising from the thorax and/or neck. \n\n Able to read and understand Danish. \n\n ", - "exclusion_criteria": ": \n\n Acute coronary syndrome. \n\n Percutaneous Coronary Intervention. \n\n Coronary Artery Bypass Grafting. \n\n Other disease, diagnosed during this admission, which is likely to have caused the acute episode of chest pain. \n\n No written consent. \n\n Inflammatory joint disease. \n\n Diabetes mellitus, type I. \n\n Fibromyalgia. \n\n Sharp trauma to the chest. \n\n Malignant disease. \n\n Apoplexy. \n\n Gross osseous anomalies, such as pronounced scoliosis. \n\n Known or suspected osteoporosis. \n\n Pregnancy. \n\n Dementia/unable to cooperate. \n\n Not residing in the County of Funen. \n\n Does not want to participate. \n\n Other - reason for exclusion will be noted.", - "brief_summary": "The overall aim of the project is to evaluate diagnosis and treatment of chest pain originating from the musculoskeletal system. Specifically, we wish to investigate prevalence and character of such chest pain in a population of patients with acute chest pain, admitted to a university hospital based acute chest pain clinic, and undergoing evaluation of acute coronary syndrome (Part 1). Then, to test a manually-based treatment protocol to patients with diagnosed musculoskeletal chest pain in a randomized clinical trial (Part 2).~The specific purpose of this study (Part 1) is to determine the exact number of patients with acute chest pain origination from the musculoskeletal system, and to describe their cardiac status with respect to ischemic heart disease. Further, we wish to evaluate the decision making process of the chiropractor.", - "NCTID": "NCT00373828" - }, - { - "brief_title": "Investigation of the Biomarker Copeptin in Patients With Acute Myocardial Infarction", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Acute Coronary Syndromes']", - "diseases_list": [ - "Acute Coronary Syndromes" - ], - "enrollment": "2071.0", - "inclusion_criteria": "inclusion criteria: \n\n The subject must be 18 years of age or older. \n\n The subject must present to the Emergency Department with symptoms consistent with acute coronary syndromes (e.g., chest discomfort/pain, squeezing/fullness in the chest, pain radiating to left or both arms, jaw pain, pain in the back/neck/stomach, shortness of breath, cold sweat, nausea/vomiting, lightheadedness). \n\n The subject must present to the Emergency Department within 6 hours of the onset of the most recent symptoms that prompted the subject to seek medical attention in the Emergency Department. \n\n The patient agrees to abide by all aspects of the protocol, including all telephone follow-up. \n\n ", - "exclusion_criteria": ": \n\n The patient is unable to provide consent or understand the consent form. \n\n The ACS symptoms are clearly not the result of ACS (i.e., penetrating wounds, crush injury, etc.)", - "brief_summary": "While troponin is not detectable until several hours after an Acute Myocardial Infarction (AMI), copeptin is expected to be elevated very early after an AMI. A combination of both markers for the diagnosis of AMI early after the event is therefore expected to be advantageous.", - "NCTID": "NCT00952744" - }, - { - "brief_title": "Muscatine Heart Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cardiovascular Diseases', 'Coronary Disease', 'Hypertension', 'Heart Diseases']", - "diseases_list": [ - "Cardiovascular Diseases", - "Coronary Disease", - "Hypertension", - "Heart Diseases" - ], - "enrollment": "", - "inclusion_criteria": "No eligibility criteria", - "exclusion_criteria": "", - "brief_summary": "To conduct longitudinal and cross-sectional studies of risk factors for coronary heart disease and hypertension in school age children and adults who had been examined in previous screens.", - "NCTID": "NCT00005127" - }, - { - "brief_title": "Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina", - "phase": "Phase 4", - "drugs": "['Amlodipine', 'iso- 5 - mononitrate', 'Blood tests', 'Exercise Stress Test']", - "drugs_list": [ - "Amlodipine", - "iso- 5 - mononitrate", - "Blood tests", - "Exercise Stress Test" - ], - "diseases": "['Myocardial Ischemia']", - "diseases_list": [ - "Myocardial Ischemia" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Outpatients > =18 years of age with diagnosed clinically stable angina pectoris \n\n ", - "exclusion_criteria": ": \n\n Patients with congestive heart failure, clinically significant cardiovascular disease, standing systolic blood pressure of less than 100mmHg, concomitant anti-anginal therapies similar to sublingual NTG", - "brief_summary": "The objective of study is to compare the anti-ischemic efficacy and safety profiles of once daily amlodipine or isosorbide-5-mononitrate in the treatment of stable asymptomatic and symptomatic myocardial ischemia", - "NCTID": "NCT00143195" - }, - { - "brief_title": "The Jackson Heart Study of Cardiovascular Disease Among African Americans", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cardiovascular Diseases', 'Heart Diseases', 'Atherosclerosis', 'Coronary Disease', 'Hypertension', 'Cerebrovascular Disorders']", - "diseases_list": [ - "Cardiovascular Diseases", - "Heart Diseases", - "Atherosclerosis", - "Coronary Disease", - "Hypertension", - "Cerebrovascular Disorders" - ], - "enrollment": "3000.0", - "inclusion_criteria": "inclusion criteria: \n\n African American \n\n Residents of Jackson, Mississippi \n\n ", - "exclusion_criteria": ": \n\n Institutionalization", - "brief_summary": "This is a prospective study of the environmental and genetic factors that influence the development of cardiovascular disease (CVD) in African American men and women. The cohort is a collaboration among multiple institutions (Jackson State University, Mississippi State Department of Health, Tougaloo College, and the University of Mississippi Medical Center), the National Institute on Minority Health and Health Disparities (NIMHD), and the National Heart, Lung, and Blood Institute (NHLBI).", - "NCTID": "NCT00005485" - }, - { - "brief_title": "Anti-hypertensive Effect of Mycelia of Antrodia Cinnamomea", - "phase": "", - "drugs": "['AC mycelia', 'Placebo']", - "drugs_list": [ - "AC mycelia", - "Placebo" - ], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "41.0", - "inclusion_criteria": "inclusion criteria: \n\n Eligible subjects were untreated hypertensive men or women aged between 20 and 80 years old with SBP between 130 and 179 mmHg and/or DBP between 85 and 109 mmHg as measured in a sitting position \n\n ", - "exclusion_criteria": ": \n\n Subjects were excluded if they had a history of major cardiovascular disease, severe liver dysfunction, insulin-dependent diabetes mellitus or stroke. They were also excluded if they routinely consumed alcohol, were pregnant or unable to comprehend study instructions.", - "brief_summary": "This the first report undertaken to assess the effect of supplementation with oral gamma-aminobutyric acid (GABA), adenosine and antrosterol-containing AC mycelia on blood pressure among people with mild hypertension. Overall, AC mycelia consumption for 8 weeks could successfully reduce mean diastolic and systolic BP through the suppression of PRA that is linked to downstream suppresion of angiotensin II formation, which further decreases the sympathetic outflow that leads to hypertension. In addition to blood pressure lowering properties, AC mycelia also has beneficial effect in reducing oxidative stress, significantly. No adverse events were noted, suggesting that AC mycelia deserve its consideration as a candidate for safe alternative treatment to conventional anti-hypertensive medications.", - "NCTID": "NCT02532699" - }, - { - "brief_title": "Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training", - "phase": "", - "drugs": "['Interval Training', 'Weight Loss']", - "drugs_list": [ - "Interval Training", - "Weight Loss" - ], - "diseases": "['Ischemic Heart Disease', 'Obesity']", - "diseases_list": [ - "Ischemic Heart Disease", - "Obesity" - ], - "enrollment": "70.0", - "inclusion_criteria": "inclusion criteria: \n\n Stable Ischemic Heart Disease \n\n BMI 28 - 40 kg/m2 \n\n ", - "exclusion_criteria": ": \n\n Known Diabetes Mellitus \n\n Repeated Fasting plasma glucose \u2265 7 mmol/L or Hba1c > 7 % \n\n Severe or moderate valve disease \n\n Main stem stenosis \n\n Severe heart failure, Ejection Fraction < 35 % \n\n Physical or mental disability which are expected to prevent completion of intervention \n\n Severe Chronic obstructive Pulmonary Disease (COPD) (FEV1 < 50 % of expected) or asthma \n\n Active cancer \n\n Severe kidney (GFR < 40 ml/hour) or severe liver disease \n\n Severe ischemia or arrhythmias during exercise test \n\n 2. or 3. degree atrio-ventricular (AV) block, not protected by pacemaker \n\n Organised training more than 2 times a week prior to inclusion \n\n Significant weight loss or weight gain (> 5 %)3 month prior to inclusion \n\n Not able to comprehend written and oral informed consent \n\n Hormone treatment", - "brief_summary": "The purpose of the study is to make a head-to-head comparison of weight loss and interval training as methods of secondary prevention in overweight patients with ischemic heart disease.", - "NCTID": "NCT01724567" - }, - { - "brief_title": "Expressive Writing for Heart Healing", - "phase": "", - "drugs": "['Disease-related Expressive writing', 'Active Comparator: Traditional expressive writing', 'Sham Comparator: Neutral writing']", - "drugs_list": [ - "Disease-related Expressive writing", - "Active Comparator: Traditional expressive writing", - "Sham Comparator: Neutral writing" - ], - "diseases": "['Ischemic Heart Disease', 'Obesity']", - "diseases_list": [ - "Ischemic Heart Disease", - "Obesity" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n obesity \n\n Ischemic Heart disease \n\n Signed informed consent \n\n ", - "exclusion_criteria": ": \n\n Visual or manual limitations that preclude reading and writing \n\n Unwilling to participate", - "brief_summary": "This study will determine whether the psychological and physical benefits of expressive writing extend to obese in-patients with Ischemic Heart Disease (IHD)referred to cardiac rehabilitation", - "NCTID": "NCT01253486" - }, - { - "brief_title": "ACE Stapler Sub Study", - "phase": "", - "drugs": "['ACE stapling procedure']", - "drugs_list": [ - "ACE stapling procedure" - ], - "diseases": "['Obesity']", - "diseases_list": [ - "Obesity" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Criteria for inclusion in main ACE stapling study: \n\n Subject must be able to understand and be willing to sign an informed consent document. \n\n Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits. \n\n Subject has a BMI of 40 - 45 or 30 to 39.9 plus one or more co-morbid diseases expected to improve with weight loss, including but not limited to hypertension, dyslipidemia, obstructive sleep apnea, or diabetes mellitus. \n\n Subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair. \n\n Subject must be of sufficient and stable medical health, as evaluated by the Principal Investigator. \n\n Subject must have a primary care physician that will manage the subject for any co-morbid conditions throughout the study. \n\n Subject must have failed standard obesity therapy of diet, exercise, behaviour modification, and pharmacologic agents either alone or in combination, as assessed by an interview with a member of the study team at baseline. \n\n Subject agrees to refrain from any type of reconstructive surgery that may affect body weight such as mammoplasty or abdominal lipoplasty or liposuction, during the trial. \n\n inclusion criteria sub study \n\n \u2022 Patient must be included in the main study \n\n ", - "exclusion_criteria": ": \n\n Main study \n\n Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease. \n\n Subject has poorly controlled diabetes as indicated by the lack of stable diabetes medications and doses over the last month, or has a history of diabetes for greater than 10 years. \n\n Subject has had significant weight loss in the last 3 months, or between baseline and the study procedure. \n\n Subject has a history or is diagnosed with eating disorders. \n\n Subject has history of peptic ulcer and tests positive for H. pylori, unless treated before the procedure. \n\n Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease. \n\n Subject has pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer. \n\n Subject has significant esophageal disease including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility. \n\n Subject is observed during EGD to have heavily scarred, malignant or poor quality/friable tissue in areas of the stomach where plications are to be placed. \n\n Subject has renal and/or hepatic insufficiency. \n\n Subject has thyroid disease which is not controlled with medication. \n\n Subject has a history of intestinal strictures or adhesions. \n\n Subject has systemic infection in the body at the time of the plication procedure. \n\n Female subject who is pregnant (i.e., has a positive urine or blood pregnancy test prior to the procedure), is suspected to be pregnant, is lactating or is of childbearing potential but refuses to use adequate contraception during the study. \n\n Female subject who started birth control pills less than 3 months before enrollment, or who plans to start taking birth control pills during the study. \n\n Subject has had previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy; gastrointestinal tumors; esophageal or gastric varices, or gastroparesis. \n\n Subject has severe coagulopathy (prothrombin time > 3 seconds over control or platelet count < 100,000) or is presently taking heparin, coumadin, warfarin, or other anticoagulants or other medications which impede coagulation or platelet aggregation. \n\n Subject has chronic/acute upper GI bleeding conditions. \n\n Subjects who are unable to discontinue use of aspirin and/or non-steroidal anti-inflammatory agents (NSAIDs) at least 14 days prior to a plication procedure and continuing for 14 days post-procedure. \n\n Subjects undergoing chronic steroid therapy. \n\n Subjects undergoing immunosuppressive therapy. \n\n Subjects who cannot discontinue either prescription or over the counter weight loss medications for at least 30 days prior to the procedure as well as during the trial period. \n\n Subjects who have started medications within the last 3 months that are known to cause weight gain. \n\n Subjects who have cardiac pacemakers or other electronic implantable devices. \n\n Subjects who have hiatal hernias greater than 2 cm. \n\n Subjects who have current or potential neck masses that in the opinion of the investigator, may interfere with study-related procedures, or has a Mallampati (intubation) score greater than 3. \n\n Subjects who have poorly controlled psychiatric disease including but not limited to manic-depressive disorder, schizophrenia, borderline personality disorder, depression or suicidal tendencies. \n\n Subject has Crohn's disease or Ulcerative Colitis. \n\n Subject currently uses or has a history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day). \n\n Subject has participated in a clinical study with an investigational new drug, biological, or therapeutic device within \u2264 28 days prior to enrollment in this study, and does not agree to abstain from participation in other clinical trials of any kind during this study. \n\n ", - "brief_summary": "Obesity and its associated conditions have reached epidemic proportions. Estimates are that about one third of the adults in the United States have obesity. At this moment there are many therapeutic approaches for the treatment of obesity. But, efficacy of most treatment options are limited and so far surgical intervention has been proven to be the only strategy to overcome severe obesity. However, bariatric surgery has limitations and risks, which might be minimized by non-incisional endoscopic procedures.~BaroSense developed a new device, called the Articulating Circular Endoscopic (ACETM) Stapler, which can be used in the treatment of obesity. It is a trans-oral procedure, which intends to reduce the ability of the stomach to expand by creating plications in the region of the fundus and greater curvature. In contrast with other bariatric surgery it is endoscopically performed, reversible and if it fails most future surgical options are still open.~The main study ('Open, prospective study to evaluate the safety and preliminary effectiveness of the BaroSense ACE\u2122 Stapler for the treatment of obesity', multicenter study (MUMC+, AMC and St. Antonius), accepted by MEC AMC) seeks to determine the safety and efficacy of this plicating system for patients with severe obesity.~In this sub-study the investogators want to unravel the exact mechanism and provide more information about the efficacy of the BaroSense ACE\u2122 Stapler. Therefore the authors will measure changes in various parameters that are known to affect weight loss and metabolism, before and after gastric plication (by using the BaroSense ACE\u2122 Stapler) in overweight subjects (these parameters will only be measured in patients at MUMC+). These parameters are post-prandial satiety, food-reward and related brain signalling, gastric emptying, behaviour towards food, food intake, satiety hormone release, microbiota composition and inflammatory markers.~Objectives:~Aim of the present study will be to assess the effect of the BaroSense ACE\u2122 stapler on postprandial satiety, food-reward and related brain signalling, gastric emptying, behaviour towards food, food intake, hormone release, microbiota composition and inflammatory markers.", - "NCTID": "NCT02381340" - }, - { - "brief_title": "Trial of a Cardiac Rehabilitation Program Delivered Remotely Through the Internet", - "phase": "", - "drugs": "['vCRP']", - "drugs_list": [ - "vCRP" - ], - "diseases": "['Cardiovascular Disease']", - "diseases_list": [ - "Cardiovascular Disease" - ], - "enrollment": "79.0", - "inclusion_criteria": "inclusion criteria: \n\n Men and women admitted for an IHD event (acute coronary syndrome or revascularization procedure) who are at low or moderate risk.91 \n\n Regular Internet access (home, work or other environment). \n\n Over 18 years of age. \n\n Permission of the attending physician. \n\n Able to read, write and understand English without difficulty. \n\n No physical limitations to regular activity. \n\n ", - "exclusion_criteria": ": \n\n Previous experience with a cardiac rehabilitation program. \n\n Patients with depression, uncontrolled diabetes and other significant co-morbidities that may interfere with effective IHD management. \n\n Those patients, who in the mind of the attending physician, are unsuitable for participation. \n\n Those unable to provide informed consent. \n\n Pregnant women. \n\n High-risk patients for safety considerations (future studies will include high-risk patients).", - "brief_summary": "Cardiac rehabilitation programs (CRP) are a proven treatment for those with ischemic heart disease (IHD). These programs have been demonstrated to improve adherence to regular physical activity, a healthy diet and smoking cessation, as well as modify risk factors for IHD such as hypercholesterolemia, hypertension, obesity and type 2 diabetes. In addition, CRP are cost effective and can result in a 25% reduction in reoccurrence of mortality. Despite the known benefits of CRP, as little as 10% to 25% of eligible patients attend these programs. One of the main barriers to attendance is proximity to a CRP, as the majority of these programs are limited to hospitals in large urban areas. However, cardiovascular diseases do not discriminate by geography, resulting in a geographic inequity of care for patients living in rural, remote and smaller urban/sub-urban centres. Currently there are no CRP specifically designed for patients in rural and remote areas. The use of the Internet may present itself as a viable alternative. We have recently completed a pilot study of a virtual CRP (vCRP) that demonstrated significant improvements in exercise capacity and risk factors. This investigation will study the vCRP in a group of IHD patients who do not have access to hospital-based CRP.~Hypotheses A. Participation in a 4 month Internet-based cardiac rehabilitation program will result in significant improvements in exercise capacity compared to usual care, in patients with diagnosed IHD.~B. Participation in a 4 month Internet-based cardiac rehabilitation program will result in significant improvements in exercise capacity after one year compared to usual care, in patients with diagnosed IHD.~Study Population Men and women over 18 years will be identified from consecutive in-patients of the British Columbia Provincial Heart Centre at St. Paul's Hospital in Vancouver who reside in either the Northern Interior or Coast Garibaldi health areas. Patients will be eligible if they have IHD, Internet access, no previous experience with cardiac rehabilitation and no physical limitations to exercise. A total of 74 patients (37 per group) will be recruited and randomized to either usual care, or a 4 month 'virtual' cardiac rehabilitation program delivered via the Internet.~Usual Care Group Patients randomized to usual care will be provided with simple guidelines for safe exercising and healthy eating habits, and return to the care of their primary care physician. Patients will return at 4 and 16 months later for outcome assessment. There will be no contact between the study personnel and usual care patients for the duration of the study, nor will there be any attempt to control the level of patient care.~Intervention The vCRP has been developed to mimic hospital-based CRP and includes online intake forms, one-on-one chat sessions with vCRP nurse, dietitian and exercise specialist, data collection (exercise heart rate, blood pressure, glucose- if diabetic), peer-support group chat sessions, ask-an-expert chat sessions, education, progress reports and online resources. Upon randomization to the intervention, patients will receive access to the website, a heart rate monitor and a blood pressure monitor and trained in their use. The heart rate monitors allow for exercise heart rate data to be stored and downloaded to their home computer and then uploaded to the vCRP webserver. The exercise data will be reviewed weekly. A letter to the patient's primary care physician will be sent to outline the vCRP intervention, the treatment algorithms to be used and indicate under what circumstances the vCRP nurse and/or patient may contact them with regards to their management. Patients will receive one-on-one counselling by the nurse, dietitian and exercise specialist via chat sessions at 3 to 4 week intervals. After the 4 month intervention, patients will be discharged into the care of their primary care physician.~Outcomes Participants will be assessed at baseline, 4 and 16 months for risk factors and lifestyle behaviours. The primary outcomes will be the change in exercise capacity as between the two groups from baseline to 4 months, and from baseline to 16 months. Exercise capacity will be assessed as total time on a symptom-limited exercise stress test.", - "NCTID": "NCT00683813" - }, - { - "brief_title": "A Cluster Randomized Trial to Assess the Impact of Opinion Leader Endorsed Evidence Summaries on Improving Quality of Prescribing for Patients With Chronic Cardiovascular Disease", - "phase": "", - "drugs": "['Opinion leader generated and endorsed evidence summaries']", - "drugs_list": [ - "Opinion leader generated and endorsed evidence summaries" - ], - "diseases": "['Coronary Disease', 'Ischemic Heart Disease', 'Heart Failure']", - "diseases_list": [ - "Coronary Disease", - "Ischemic Heart Disease", - "Heart Failure" - ], - "enrollment": "160.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with HF or IHD who are not currently taking the study medications of interest (ACE inhibitors/angiotensin receptor blockers for HF or statins for IHD) and whose primary care physicians are part of the study population \n\n ", - "exclusion_criteria": ": \n\n Patients who are unable or unwilling to give informed consent, \n\n previously taken the study medications according to dispensing records \n\n allergy or intolerance to study medications \n\n residents of long-term care facilities \n\n unable to confirm a diagnosis of either HF or IHD \n\n primary care physician has already contributed 5 patients to the study", - "brief_summary": "BACKGROUND: Although much has been written about the influence of local opinion leaders on clinical practice, there have been few controlled studies of their effect, and almost none have attempted to change prescribing in the community for chronic conditions such as congestive heart failure (CHF) or ischemic heart disease (IHD). These two conditions are common and there is very good evidence about how to best prevent morbidity and mortality - and very good evidence that quality of care is, in general, suboptimal. Practice audits have demonstrated that about half of eligible CHF patients are prescribed ACE inhibitors (and fewer still reaching appropriate target doses) and less than one-third of patients with established IHD are prescribed statins (with many fewer reaching recommended cholesterol targets). It is apparent that interventions to improve quality of prescribing are urgently needed.~HYPOTHESIS: An intervention that consists of patient-specific one-page evidence summaries, generated and then endorsed by local opinion leaders, will be able to change prescribing practices of community-based primary care physicians.~DESIGN: A single centre randomized controlled trial comparing an opinion leader intervention to usual care. Based on random allocation of all physicians in one large Canadian health region, patients with CHF or IHD (not receiving ACE inhibitors or statins, respectively) recruited from community pharmacies will be allocated to intervention or usual care. The primary outcome is improvement in prescription of proven efficacious therapies for CHF (ACE inhibitors) or IHD (statins) within 6 months of the intervention.", - "NCTID": "NCT00175279" - } - ] - }, - { - "patient_id": "sigir-20142", - "patient": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", - "0": [ - { - "brief_title": "Randomized Controlled Trial (RCT) in Children With Severe Pneumonia", - "phase": "", - "drugs": "['Day-care treatment vs. hospital care']", - "drugs_list": [ - "Day-care treatment vs. hospital care" - ], - "diseases": "['Severe Pneumonia']", - "diseases_list": [ - "Severe Pneumonia" - ], - "enrollment": "368.0", - "inclusion_criteria": "inclusion criteria: \n\n Age: 2 to 59 months \n\n Sex: Both boys and girls \n\n Severe pneumonia according to WHO criteria (Severe pneumonia is defined as cough or difficult breathing with lower chest wall in drawing with or without fast breathing which is defined as the respiratory rate \u2265 50 breaths per minute for children aged 2-11 months and \u2265 40 breaths per minute for children aged 12-59 months) \n\n Attend the Radda Clinic and ICHSH between 8:00 am to 4:00 pm (Sunday through Saturday) \n\n Written informed consent by respective parents/guardians \n\n ", - "exclusion_criteria": ": \n\n Very severe and non-severe pneumonia \n\n Nosocomial pneumonia \n\n History of taking antibiotics for pneumonia within 48 hour prior to enrollment \n\n Chronic illnesses like tuberculosis, cystic fibrosis \n\n Congenital deformities/anomalies e.g. Down's Syndrome, congenital heart disease \n\n Immunodeficiency \n\n Trauma/burn \n\n Bronchiolitis \n\n Bronchial asthma \n\n Lives far away from the Radda Clinic and ICHSH (outside 5 km radius from the respective study site) \n\n Parents/guardians not consenting for inclusion of their children in the study", - "brief_summary": "Pneumonia is the leading cause of childhood morbidity and death in many developing countries including Bangladesh, causing about 2 million deaths worldwide each year. Pneumonia is an infection of the lungs, most commonly caused by viruses or bacteria like Streptococcus pneumoniae and Haemophilus influenzae. Depending on the clinical presentation, pneumonia can be classified as very severe, severe or non-severe, with specific treatment for each of them except for antibiotic therapy. Severe and very severe pneumonia require hospitalization for additional supportive treatment such as suction, oxygen therapy and administration of bronchodilator. In Bangladesh, the number of hospital beds is inadequate for admission of all pneumonia cases that require hospitalization; however, it is also important to provide institutional care to those children who cannot be hospitalized due to bed constraints. Provision of appropriate antibiotics and supportive cares during the period of stay at established day-care centres could be an effective alternative. The impetus for this study came from the findings of our recently completed study titled Daycare-based management of severe pneumonia in under-5 children when hospitalization is not possible due to the lack of beds. This study successfully managed children (n=251), but it was not a randomized trial and thus direct comparison of the efficacy of management of severe pneumonia at the day-care centre, essential for building confidence for implementing this management policy, is not possible. We, the researchers at the International Centre for Diarrhoeal Disease Research, Bangladesh, could not plan a randomized, controlled trial (RCT) because of ethical reasons. Now that we have data suggesting effectiveness as well as safety of the day-care based treatment for management of children with severe pneumonia, a RCT should be possible. Two hundred fifty-one children with severe pneumonia were enrolled at the Radda Clinic from June 2003 to May 2005. The mean age was 7\u00b17 (2-55) months, 86% infants, 63% boys and 91% breast-fed. History of cough was present in 99% cases, fever in 89% and rapid breathing in 67% cases. Forty-four percent of children were febrile (\u226538\u00b0C), 93% children had vesicular breath sound and 99% bilateral rales. Fifty-seven percent of children were hypoxic with mean oxygen saturation of (93\u00b14)%, which was corrected by oxygen therapy (98\u00b13)%. Eighty percent of children had severe pneumonia and 20% had very severe pneumonia. The mean duration of clinic stay was (7\u00b12) days. Two hundred thirty-four (93%) children completed the study successfully, 11 (4.4%) referred to hospitals (only one participant had to visit hospital at night due to deterioration of his condition, 9 were referred to hospital at the time of clinic closure i.e., at 5 pm and one participant was referred to hospital during the morning hours) and 6 (2.4%) left against medical advice (LAMA). There was no death during the period of clinic stay but only four (1.6%) deaths occurred during the 3 months follow-up. The study indicated that treatment of severe pneumonia in children at the day-care centre is effective and safe and thus it is comparable to the hospital care. If the day-care based management is found to have comparable efficacy to that of hospitalized management of severe pneumonia in children then they could be managed at outpatient, day-care set ups reducing hospitalization and thus freeing beds for management of other children who need hospitalized care. Additionally, availability of the treatment facility in community set-ups will be cost and time saving for the population. Children of either sex, aged 2-59 months, attending the Radda Clinic and Institute of Child Health and Shishu Hospital (ICHSH) with severe pneumonia will be randomized to receive either the day-care management at the clinic or hospitalized management at the ICHSH. Children randomized to receive day-care treatment will stay at the clinic from 8 am-5 pm and will receive antibiotics and other supportive cares. At 5 pm, they would be send to respective homes with advice to bring back their children to the clinic next morning, and advised to provide other supports at home. The same management would be continued till improvement and discharged and followed up every 2 weeks for 3 months. Children randomized to receive hospitalized management would be admitted at ICHSH and receive standard treatment like antibiotics and other supportive cares. The same treatment would be continued for 24 hours/day (rather than 9 hours/day at the day-care clinic) till improvement and discharged and followed-up at the ICHSH every 2 weeks for 3 months. About 3000 children with pneumonia visit Radda Clinic each year and about 200 of them will have severe pneumonia requiring hospitalization. Thus, we hope to enroll 368 (184 in each site) children with severe pneumonia during a 2-year study period.", - "NCTID": "NCT00455468" - }, - { - "brief_title": "Trial of Amoxicillin Compared With Placebo for Pneumonia in Children Aged 2-59 Months", - "phase": "", - "drugs": "['Amoxicillin', 'Placebo']", - "drugs_list": [ - "Amoxicillin", - "Placebo" - ], - "diseases": "['Acute Respiratory Infections', 'Pneumonia']", - "diseases_list": [ - "Acute Respiratory Infections", - "Pneumonia" - ], - "enrollment": "900.0", - "inclusion_criteria": "inclusion criteria: \n\n Children aged 2 to 59 months attending the outpatient's clinics of participating sites \n\n WHO defined non-severe pneumonia \n\n Accessibility for follow-up \n\n Written informed consent by a parent or legal guardian \n\n ", - "exclusion_criteria": ": \n\n WHO signs of severe pneumonia recognised by lower chest wall retraction. Children who present with wheezing will be evaluated for lower chest wall indrawing after treatments with nebulised salbutamol. WHO signs of very severe disease/pneumonia defined as any of the following: \n\n Cyanosis \n\n Inability to drink \n\n Convulsions \n\n Abnormally sleepy or difficult to wake \n\n Severe malnutrition recognised by weight for age less than third percentile by the NCHS (National Child Health Statistics) growth chart and/or oedema (see chart). \n\n All patients with a previous history of 3 or more episodes of wheeze or diagnosed to have asthma. \n\n Known or clinically recognisable congenital heart disease with cyanosis or, congestive heart failure or cardiomegaly. \n\n Known or clinically recognisable acute/chronic organ system disorders including jaundice, nephrotic syndrome, severe anaemia manifested as extreme pallor etc. \n\n Other infectious conditions requiring antibiotic therapy at the day of contact including meningitis, tuberculosis, dysentery, osteomyelitis, septic arthritis etc. \n\n Children who have taken the appropriate doses of WHO-recommended dose of anti microbial drug for 48 hours prior to presentation. \n\n A history of hospitalization in the past 2 weeks \n\n Measles or a history of measles within the last month: Measles recognized by presence of fever with rash, and conjunctivitis. \n\n Prior enrolment in the current trial. \n\n Known penicillin allergy, including a history of rash, urticaria, or anaphylactic symptoms. \n\n The children living outside the municipal limits of the city who cannot be followed up.", - "brief_summary": "Many children with non-severe pneumonia (cough and fast breathing) have neither clinical pneumonia as assessed by physicians nor pneumonia on chest radiographs. Inappropriate use of antibiotics for these cases is leading to resistant strains of bacteria in the community. Evidence shows that almost 50% of antibiotic prescription is unnecessary.As over half of antibiotic prescription for ARI are not necessary since most of these infections are viral and do not respond to antibiotic therapy which will be source of resistance in the community.~To address this issue the investigators conducted this randomized, double blind placebo controlled clinical trial of oral Amoxicillin versus placebo in children with non-severe pneumonia taking into account all the necessary safety precautions for their well being.~The study hypothesis was that the clinical outcome of children 2 to 59 months of age with cough and fast breathing (WHO defined non-severe pneumonia) with or without wheezing is equivalent, whether they are treated with amoxicillin or placebo.", - "NCTID": "NCT00851487" - }, - { - "brief_title": "Epidemiological Study on Community Acquired Pneumonia", - "phase": "", - "drugs": "['Cohort Study']", - "drugs_list": [ - "Cohort Study" - ], - "diseases": "['Community Acquired Pneumonia']", - "diseases_list": [ - "Community Acquired Pneumonia" - ], - "enrollment": "10150.0", - "inclusion_criteria": "inclusion criteria: \n\n age \u2265 18 \n\n infiltrate on chest X-ray \n\n further inclusion criteria: cough or production of purulent sputum or pathologic lung auscultation (crackles) or fever \n\n ", - "exclusion_criteria": ": \n\n hospital inpatient treatment within the last 28 days \n\n Immune suppressed patients", - "brief_summary": "Long-term objectives of the basic research part are improvement of CAP-management with respect to therapy, diagnosis and prevention to contribute to a better care of patients with pneumonia.", - "NCTID": "NCT02139163" - }, - { - "brief_title": "Zambia Integrated Management of Malaria and Pneumonia Study", - "phase": "", - "drugs": "['Coartem and amoxicillin', 'Coartem']", - "drugs_list": [ - "Coartem and amoxicillin", - "Coartem" - ], - "diseases": "['Pneumonia', 'Malaria']", - "diseases_list": [ - "Pneumonia", - "Malaria" - ], - "enrollment": "3125.0", - "inclusion_criteria": "inclusion criteria: \n\n Age between 6 months and 5 years \n\n Present with history of fever or reported fever \n\n Present with cough or difficult breathing \n\n ", - "exclusion_criteria": ": \n\n Age below 6 months and above 5 years \n\n Presence of signs and symptoms of severe illness", - "brief_summary": "The purpose of the study is to demonstrate the effectiveness and feasibility of community-based management of pneumonia and malaria by community health workers (CHWs) in a rural district of Zambia.", - "NCTID": "NCT00513500" - }, - { - "brief_title": "Transmission and the Respiratory Tract in Cryptosporidiosis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cryptosporidiosis']", - "diseases_list": [ - "Cryptosporidiosis" - ], - "enrollment": "480.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female children aged 9-36 months at the time of enrollment \n\n Presence of acute or persistent diarrhea (diarrhea defined as 3 or more loose stool in the previous 24 hours AND not considered normal for that child if the child is exclusively breast fed OR any number of bloody stools in the previous 24 hours; less than or equal to 14 days duration for acute diarrhea; >14 days duration for persistent diarrhea) \n\n Child's parent/guardian speaks English or Luganda \n\n Parent/guardian provides full and free informed consent for child to participate in study \n\n ", - "exclusion_criteria": ": \n\n Unknown age \n\n Known cardiac, CNS, metabolic or endocrine disorders \n\n Moribund children \n\n Children with recent history of choking or sudden onset of symptoms with suspected foreign body inhalation", - "brief_summary": "Cryptosporidium is an intestinal parasite that causes diarrhea in children and adults. In addition to infection of the stomach, this parasite can infect the respiratory system causing a cough and/or problems breathing. This study will enroll 480 children between the ages of 9 and 36 months who come to Mulago Hospital for treatment of diarrhea. Researchers believe a large number of children with diarrhea and cough will have the parasite present in their sputum (mucus coughed up). Researchers also believe that children who have respiratory tract cryptosporidiosis may have a cough, increased number of breaths per minute, and/or a lower oxygen level. Blood, stool, saliva, and sputum samples will be collected from all children in the study and tested for Cryptosporidium. Children too young to provide a sputum sample will have a tube placed to collect a mucus sample from the lungs. Study participation may be as short as 4 hours or as long as 2 days depending on each child's health.", - "NCTID": "NCT00507871" - }, - { - "brief_title": "KEYS: Study Comparing Clinical Health Outcomes of Telithromycin Versus Azithromycin in Outpatients With Community-acquired Lower Respiratory Tract Infections", - "phase": "Phase 4", - "drugs": "['Telithromycin', 'Azithromycin']", - "drugs_list": [ - "Telithromycin", - "Azithromycin" - ], - "diseases": "['Respiratory Tract Infections', 'Chronic Bronchitis', 'Pneumonia']", - "diseases_list": [ - "Respiratory Tract Infections", - "Chronic Bronchitis", - "Pneumonia" - ], - "enrollment": "2051.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects meeting all of the following criteria will be considered for enrollment into the study: \n\n Male and female adult outpatient subjects diagnosed with AECB or CAP \n\n Female subjects must be either postmenopausal for \u2265 1 year or surgically incapable of bearing children. Women of childbearing potential must have a normal menstrual flow \u2264 1 month before study entry, a negative serum pregnancy test immediately prior to study entry, and meet the criteria for acceptable birth control. \n\n Informed consent must be obtained in writing for all subjects upon enrollment. \n\n Subjects will have a diagnosis of AECB or CAP, as defined below. \n\n AECB-Specific inclusion criteria: \n\n Subjects greater than or equal to 35 years of age \n\n Subjects with a documented history of chronic bronchitis: with a basal forced expiratory volume in one second (FEV1) < 70% and > 35%; who have had at least one or more AECB in the previous year; and with FEV1/forced vital capacity (FVC) < 70%. \n\n Subjects with a clinical diagnosis of AECB, presumed to be due to bacterial infection based on increased sputum purulence with either increased dyspnea or sputum volume \n\n Subjects producing spontaneous sputum \n\n Subjects with a \u2265 10 pack-year history of cigarette smoking \n\n CAP-Specific inclusion criteria: \n\n Fever (oral temperature > 38\u00b0C [100.4\u00b0F] or tympanic temperature > 38.5\u00b0C [101.2\u00b0F] or rectal temperature > 39\u00b0C [102.2\u00b0F]) \n\n Chills \n\n Pleuritic chest pain \n\n Cough \n\n Spontaneous production of purulent sputum or a change in sputum character \n\n Auscultatory findings (such as rales [also known as crepitations] and/or evidence of pulmonary consolidation [ie, dullness on percussion, bronchial breath sounds, egophony]) \n\n Subjects greater than or equal to 18 years of age \n\n Chest x-ray findings that support a clinical diagnosis of bacterial pneumonia (eg, presence of presumably new infiltrate[s]) \n\n Subjects with a clinical diagnosis of mild to moderate CAP due to bacterial infection based on at least 1 of the following signs and symptoms of CAP: \n\n In addition, subjects with a clinical diagnosis of CAP will have at least 1 of the following signs and symptoms of CAP: \n\n Dyspnea or tachypnea (particularly if progressive in nature) \n\n ", - "exclusion_criteria": ": \n\n Subjects presenting with any of the following will not be included in the study: \n\n Subjects with a known history of congenital long-QTc syndrome \n\n Subjects who are pregnant or breast-feeding \n\n Subjects who have hypersensitivity to telithromycin, azithromycin, or the macrolide classes of antibiotics \n\n Subjects who require or receive treatment with rifampin (Rifadin), phenytoin (Dilantin), carbamazepine (Carbatrol, Tegretol), phenobarbital, or St. John's wort (herbal supplement) within 2 weeks prior to Visit 1 or during the study \n\n Subjects who require treatment during the study with ergot alkaloid derivatives, cisapride (Propulsid), pimozide (Orap), bromocriptine, cabergoline (Dostinex), or pergolide (Permax) \n\n Subjects who have previously participated in this study \n\n Subjects with a previous history of myasthenia gravis \n\n Subjects with current acute respiratory failure or subjects who require aggressive airway management \n\n Hospitalized subjects and subjects from institutional care facilities \n\n Subjects who have been treated with oral or parenteral antibiotics within 14 days prior to enrollment or who plan to take antibiotics other than study drug during the treatment period \n\n Subjects who are receiving other medications, including systemic antimicrobial agents, or who have other disease conditions or infections that could interfere with the evaluation of drug efficacy or safety \n\n Subjects with a concomitant condition (including clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease) that makes either implementation of the protocol or interpretation of the study results difficult \n\n Subjects with a progressively fatal disease or life expectancy of < 3 months \n\n Subjects who have received any other investigational drug or device within 1 month prior to study entry, or who have such treatment planned during the study period \n\n Subjects with a recent (within 3 months) history of drug or alcohol abuse \n\n Immunocompromised subjects, including but not limited to subjects with: known human immunodeficiency virus infection (CD4 count < 200/mm3); known neutropenia (< 1500 neutrophils/mm3); chronic corticosteroid therapy (\u2265 10 mg/day prednisolone therapy or equivalent for at least the past 3 months); immunosuppressant treatment, other than corticosteroids, within the previous 6 months; splenectomized subjects or subjects with known hyposplenia or asplenia. \n\n Subjects with mental conditions that render them unable to understand the nature, scope, and possible consequences of the study \n\n Subjects who are unlikely to comply with the protocol (eg, have an uncooperative attitude, an inability to return for follow-up visits, or are unlikely to complete the study) \n\n Subjects who have known impaired hepatic function \n\n Subjects who have known impaired renal function \n\n AECB-Specific ", - "brief_summary": "The purpose of this study is to determine if 1 course of antibiotic treatment with telithromycin is superior to azithromycin in the treatment of lower respiratory tract infections (LRTIs), acute exacerbations of chronic bronchitis (AECBs) and community-acquired pneumonia (CAP) in the community setting.", - "NCTID": "NCT00132951" - }, - { - "brief_title": "Bi-Level Positive Airway Ventilation for Acute Chest Syndrome", - "phase": "", - "drugs": "['Bi-level positive airway pressure device', 'Sham CPAP']", - "drugs_list": [ - "Bi-level positive airway pressure device", - "Sham CPAP" - ], - "diseases": "['Sickle Cell Anemia', 'Acute Chest Syndrome']", - "diseases_list": [ - "Sickle Cell Anemia", - "Acute Chest Syndrome" - ], - "enrollment": "3.0", - "inclusion_criteria": "inclusion criteria: \n\n patients diagnosed with Hemoglobin SS (HB SS), the most common type of sickle cell disease \n\n patients diagnosed with Hemoglobin SC (HB SC), the second most common type of sickle cell disease. \n\n patients diagnosed with Hemoglobin sickle beta-zero thalassemia ( HB SB0thal) or Hemoglobin sickle thalassemia (HB SBthal) \n\n Must meet clinical criteria for ACS- an infiltrate on Chest X-ray and one of the following: \n\n Respiratory symptoms/signs (patients pulse oximetry < 92% or oxygen saturation < 2% below their baseline, tachypnea, cough, and increased work of breathing) \n\n Fever \n\n Chest pain AND \n\n Patients' eligible for a simple transfusion based on one of the following criteria: \n\n Hypoxemia (patients pulse oximetry < 92% or oxygen saturation < 2% below their baseline) \n\n Hemoglobin < 5 gm/dl \n\n Increased work of breathing \n\n ", - "exclusion_criteria": ": \n\n Patient requires exchange transfusion within first 24 hours of admission \n\n Patient requires PCCU transfer within first 24 hours of admission \n\n Hemoglobin > 9gm/dl secondary to these patients requiring an exchange transfusion", - "brief_summary": "Acute chest syndrome (ACS) is a frequent complication of sickle cell disease and is diagnosed by having findings on a chest x-ray and one of the following: chest pain, fever, or trouble breathing. Patients with Acute Chest Syndrome can get very sick and require an exchange transfusion (special large blood transfusion) and mechanical ventilation. Bi-level Positive Airway Pressure (also known as BLPAP or BiPAP) is a device that blows air into a patients lungs via a mask that covers the nose. The goal of this study is to determine whether giving children BiPAP when they have ACS, in addition to providing standard clinical care for ACS, alters the clinical course of these patients. The investigators hypothesize that patients receiving effective BiPAP will have milder clinical courses resulting in shorter hospital stays and fewer transfers to the intensive care unit and exchange transfusions.", - "NCTID": "NCT01589926" - }, - { - "brief_title": "Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)", - "phase": "", - "drugs": "['clarithromycin modified release 500 mg']", - "drugs_list": [ - "clarithromycin modified release 500 mg" - ], - "diseases": "['Respiratory Tract Infection']", - "diseases_list": [ - "Respiratory Tract Infection" - ], - "enrollment": "335.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults, equal to or more than 18 years years of age \n\n Patients with respiratory tract infections, including any of the following: \n\n Acute tracheitis, acute tracheobronchitis \n\n Acute sinusitis \n\n Chronic sinusitis \n\n Acute tonsillopharyngitis \n\n Acute bronchitis \n\n Mild community-acquired pneumonia \n\n Acute exacerbation of chronic bronchitis \n\n ", - "exclusion_criteria": ": \n\n Known hypersensitivity to or previously intolerant of macrolides. \n\n Illness severe enough to warrant hospitalization or parenteral therapy. \n\n Concomitant use of any of the following medications: \n\n Drugs metabolized by CYP3A isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine. \n\n Drugs metabolized by other isozymes within CYP450 system: phenytoin, theophylline and valproate. \n\n Colchicine, Digoxin, Some antiretrovirals: zidovudine and ritonavir. \n\n Severe immunodeficiency and chronic disease conditions. \n\n Renal or hepatic impairment (creatinine clearance under 30 mL/min, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyltransferase (GGT) equal or more than 3x higher level in comparison with the norm). \n\n Mental condition rendering the subject unable to understand the nature of the study.", - "brief_summary": "The objective is to describe the time to recovery of symptoms (cough, mucus, fever, sore throat, and others), tolerability and compliance of treatment with clarithromycin once daily in patients with upper or lower respiratory tract infections in the routine clinical practice.", - "NCTID": "NCT01075204" - }, - { - "brief_title": "Chest Imaging, Breath, and Biomarkers in a Screening Trial", - "phase": "", - "drugs": "['chest x-ray with or without CAD, lose dose CT scan']", - "drugs_list": [ - "chest x-ray with or without CAD", - "lose dose CT scan" - ], - "diseases": "['Lung Cancer']", - "diseases_list": [ - "Lung Cancer" - ], - "enrollment": "1424.0", - "inclusion_criteria": "inclusion criteria: \n\n ages 40-75 years \n\n If ages 40-59, then one of the following criteria needs to be met: \n\n Current or ex-smoker with >25 pack years and a family history of lung cancer(parent or sibling) OR \n\n current or ex-smoker with > 25 pack years and COPD OR \n\n current or ex-smoker with a > 35 pack year history \n\n If ages 60-75, then one of the following additional criteria needs to be met: \n\n Current or ex-smoker with >25 pack years and a family history of lung cancer (parent or sibling) OR \n\n Current or ex-smoker with >25 pack years and COPD OR \n\n Current or ex-smoker with a >30 pack year history \n\n Subject is able to return to Cleveland Clinic for annual follow-up screening \n\n Subject is willing to sign a medical release form \n\n ", - "exclusion_criteria": ": \n\n Current health requires oxygen \n\n Have had a chest x-ray or CT of the chest within the last 6 months \n\n Previous pneumonectomy \n\n Lobectomy of the lung within the last 5 years \n\n Diagnosed malignancy within the last 5 years, excluding non-melanoma skin cancer, carcinoma in situ of the cervix and localized prostate cancer \n\n A medical condition that would prevent treatment for lung cancer \n\n Within the last 6 weeks, one of the following has occured: \n\n A new cough or chronic cough that has gotten worse \n\n Either new shortness of breath, or any worsening of shortness of breath \n\n A cough producing blood \n\n Constant chest pain \n\n Respiratory infection, pneumonia, or cold \n\n Unintentional and unexplained weight loss greater than 5% of total body weight", - "brief_summary": "The investigators would like to see if lung cancer screening with chest x-rays,computer aided detection (CAD)and a lose dose CT scan can detect lung cancer in early stages when it is more responsive to treatment. The investigators would also like to see if early detection will reduce the incidence of symptomatic advanced lung cancer compared to no screening in former and current smokers with or without a family history of lung cancer who are 40-75 years old.", - "NCTID": "NCT01663155" - }, - { - "brief_title": "Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children", - "phase": "Phase 4", - "drugs": "['ibuprofen, dipyrone, acetaminophen']", - "drugs_list": [ - "ibuprofen", - "dipyrone", - "acetaminophen" - ], - "diseases": "['Fever']", - "diseases_list": [ - "Fever" - ], - "enrollment": "396.0", - "inclusion_criteria": "inclusion criteria: \n\n male and female children aged 06 months to 06 years old, weight above 5 kilo and axillary temperature above 37,5 celsius degree. \n\n ", - "exclusion_criteria": ": \n\n patients with a bad general heath state \n\n patients with neoplasia, pepic ulcer, gastrointestinal bleeding,history of fever convulsion; \n\n intolerant to dypirone, ibuprofen, acetaminophen or any other nonsteroidal antiinflammatory drug; \n\n moderated or severe dehydration; \n\n conscience state alteration; \n\n not capable of ingest oral drugs; \n\n patients being treated with steroids; \n\n patients treated with antiinflammatory, analgesic and antipyretic drugs in the last 06 hours before the study.", - "brief_summary": "The purpose of this study was to compare the efficacy and tolerability of acetaminophen, dipyrone and ibuprofen to fever control in children.~For the efficacy asses were compared:~the time to start the action;~the action duration;~the difference between the basal temperature and the lower temperature in the study period.~For the tolerability asses all adverse events were recorded, as well as your intensity and the relation to the treatment.", - "NCTID": "NCT01359020" - }, - { - "brief_title": "Human Immune Responses to Yellow Fever Vaccination", - "phase": "Phase 4", - "drugs": "['Yellow Fever Virus Vaccine']", - "drugs_list": [ - "Yellow Fever Virus Vaccine" - ], - "diseases": "['Yellow Fever']", - "diseases_list": [ - "Yellow Fever" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Able to understand and give informed consent \n\n Age 18-45 years \n\n If possible, participants agree not to take any vaccines within 30 days before or 30 days after yellow fever vaccination \n\n Women of child bearing potential must agree to use effective birth control throughout the duration of the study. A negative urine pregnancy test must be documented prior to vaccination. \n\n ", - "exclusion_criteria": ": \n\n Lived in a country/area which is endemic for yellow fever \n\n History of previous yellow fever, West Nile, Dengue, St. Louis encephalitis, Japanese encephalitis vaccination or infection \n\n Any history of allergy to eggs, chicken or gelatin or to any previous vaccine \n\n A history of a medical condition resulting in impaired immunity (such as HIV infection, cancer, particularly leukemia, lymphoma, use of immunosuppressive or antineoplastic drugs or X-ray treatment). Persons with previous skin cancers or cured non-lymphatic tumors are not excluded from the study. \n\n History of HIV infection, Hepatitis B or Hepatitis C infection \n\n History of any chronic medical conditions that are considered progressive (ex, diabetes, heart disease, lung disease, liver disease, kidney disease, gastrointestinal diseases and uncontrolled hypertension). Use of systemic immunosuppressive medications (ex, prednisone) for 2 weeks or more in the past 3 months \n\n History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the trial \n\n Thymus gland problems (such as myasthenia gravis, DiGeorge syndrome, thymoma) or removal of thymus gland or history of autoimmune disorder \n\n Recipient of a blood products or immune globulin product within 42 days of the vaccination visit \n\n Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration \n\n Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial \n\n Received the second coronavirus disease 2019 (COVID-19) vaccine less than 21 days before receiving the Yellow Fever Vaccine. \n\n COVID-19 infection in the last 60 days. Symptoms of COVID-19 symptoms must be completely resolved before yellow fever vaccine receipt.", - "brief_summary": "The goal of this study is to use the live attenuated yellow fever vaccine, YFV-17D (YF-VAX\u00ae, Sanofi-Pasteur) as a safe and effective model for viral infection to understand human immune response to viral antigens. Study participants will receive the yellow fever vaccine and participation in the study may be as short as one month or as long as one year, depending on immune responses.", - "NCTID": "NCT00694655" - }, - { - "brief_title": "Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years", - "phase": "Phase 3", - "drugs": "['FSME-IMMUN NEW 0.25 ml']", - "drugs_list": [ - "FSME-IMMUN NEW 0.25 ml" - ], - "diseases": "['Tick-borne Encephalitis']", - "diseases_list": [ - "Tick-borne Encephalitis" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Male and female children and adolescents will be eligible for participation in this study if: \n\n they are aged 1 year (from the 1st birthday) to < 16 years (to the last day before the 16th birthday); \n\n they are clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial); \n\n their parents/legal guardians understand the nature of the study and agree to its provisions; \n\n written informed consent is available from both parents/legal guardians, \n\n for Germany/Austria: additional written informed consent is available for children older than 8 years \n\n they or their parents/legal guardians agree to keep a volunteer diary. \n\n For safety reasons, female volunteers who have reached sexual maturity at study start have to meet the following additional inclusion criteria: \n\n - negative pregnancy test at study entry; \n\n ", - "exclusion_criteria": ": \n\n Children and adolescents will be excluded from participation in this study if they: \n\n have a history of any TBE vaccination; \n\n have a history of TBE infection; \n\n have a history of allergic reactions to one of the components of the vaccine; \n\n suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions; \n\n are known to be HIV positive (a special HIV test is not required for the purpose of the study); \n\n have received banked blood or immunoglobulins within one month of study entry; \n\n have a history of vaccination against yellow fever and/or Japanese B-encephalitis; \n\n suffer from hemorrhagic diathesis; \n\n are participating simultaneously in another clinical trial; \n\n if female: are pregnant or breastfeeding. \n\n Volunteers who meet the inclusion/", - "brief_summary": "The purpose of this study is to investigate the safety of five consecutive lots of FSME-IMMUN NEW in healthy volunteers. The main criterion for investigation is the fever rate after the first vaccination in three different age classes. The immunogenicity of 0.25 ml FSME-IMMUN NEW has been demonstrated in previous clinical studies in children; therefore, in the present study, immunogenicity was investigated in a subgroup only.", - "NCTID": "NCT00161863" - }, - { - "brief_title": "Nitric Oxide Inhalation to Treat Sickle Cell Pain Crises", - "phase": "Phase 2", - "drugs": "['Nitric Oxide', 'Placebo']", - "drugs_list": [ - "Nitric Oxide", - "Placebo" - ], - "diseases": "['Anemia, Sickle Cell']", - "diseases_list": [ - "Anemia", - "Sickle Cell" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Each subject must meet all of the following inclusion criteria during the screening process in order to participate in the study: \n\n Patient must have a diagnosis of SCD (known SS, S-Beta-thalassemia or other hemoglobinopathies causing sickle cell disease). Patients with disease due to Hgb SC are not permitted. \n\n Must present to the ED/EC or other appropriate unit in VOC. \n\n Greater than or equal to 10 years old. \n\n Written informed consent/assent has been obtained. \n\n ", - "exclusion_criteria": ": \n\n Subjects meeting any of the following criteria during baseline evaluation will be excluded from entry into the study: \n\n Exposure to therapeutic nitric oxide within the past 12 hours. \n\n Patient has received sildenafil or other phosphodiesterase 5 inhibitors, therapeutic L-arginine, nitroprusside or nitroglycerine within the past 12 hours. \n\n Patient has received previous ED/EC or other appropriate unit treatment for a vaso-occlusive crisis less than 48 hours or hospitalization less than 14 days ago (patients transferred directly from another ED or clinic may be enrolled). \n\n Patient has visited the ED/EC or other appropriate unit greater than 10 times in the past year having a vaso-occlusive crisis. \n\n Patients presenting with clinically diagnosed bacterial infection (e.g., osteomyelitis, pneumonia, sepsis or meningitis). \n\n Patients who are currently enrolled in any other investigational drug study except for hydroxyurea studies. \n\n Pregnant women (urine HCG + )/ nursing mothers. \n\n Patients who have received an exchange transfusion (not simple transfusion) in the last 30 days or are on a chronic simple or exchange transfusion program. \n\n Suspected splenic sequestration. \n\n Acute chest syndrome or pneumonia: Abnormal new pulmonary infiltrate (alveolar infiltration and not atelectasis) and one or more pulmonary signs and/or symptoms (fever, rales, wheezing, cough, shortness of breath, retractions). \n\n Previous participation in this study.", - "brief_summary": "This study will examine whether nitric oxide (NO) gas can reduce the time it takes for pain to go away in patients who are in sickle cell crisis. NO is important in regulating blood vessel dilation, and consequently, blood flow. The gas is continuously produced by cells that line the blood vessels. It is also transported from the lungs by hemoglobin in red blood cells.~Patients 10 years of age or older with sickle cell disease (known SS, S-beta-thalassemia or other blood problems causing sickle cell disease) may be eligible for this study. Patients whose disease is due to hemoglobin (Hgb) SC are excluded. Candidates are screened with blood tests and a chest x-ray to look at the lungs and heart.~Participants are admitted to the hospital in a pain crisis. They are evaluated and then randomly assigned to receive one of two treatments: 1) standard treatment plus NO, or 2) standard treatment plus placebo. The placebo used in this study is nitrogen, a gas that makes up most of the air we breathe and is not known to help in sickle cell disease.~For the first 8 hours of the study, patients receive placebo or NO through a facemask. The mask may be taken off for 5 minutes every hour and for not more than 20 minutes to eat a meal. After the first 8 hours, the gas is delivered through a nasal cannula (small plastic tubing that rests under the nose) that may be taken off only while showering or using the restroom. Patients are questioned about the severity of their pain when they start the study and then every few hours while they are in the hospital. Their vital signs (temperature, breathing rate, and blood pressure) and medicines are checked. Patients will breathe the gas for a maximum of 3 days, but will stay hospitalized until the patient feels well enough to go home. Patients are followed up about 1 month after starting the study by a return visit to the hospital or by a phone call.", - "NCTID": "NCT00094887" - }, - { - "brief_title": "Study to Evaluate the Effectiveness of Rotarix\u2122 Against Severe Gastroenteritis Among Hospitalized Children in Brazil", - "phase": "", - "drugs": "['Stool sampling']", - "drugs_list": [ - "Stool sampling" - ], - "diseases": "['Rotavirus Gastroenteritis']", - "diseases_list": [ - "Rotavirus Gastroenteritis" - ], - "enrollment": "1944.0", - "inclusion_criteria": "inclusion criteria: \n\n For cases: \n\n A male or female child born after 6 March 2006 and at least 12 weeks of age. \n\n Subject admitted to the study clinics/hospitals for severe gastroenteritis during the study period. \n\n Onset of severe gastroenteritis \u2264 14 days prior to admission. \n\n Laboratory confirmed rotavirus positive stool sample at hospital admission or during the first 48 hours of hospitalization. \n\n Written informed consent obtained from the parent or guardian of the subject. \n\n For controls: \n\n Admitted for non-gastroenteritis causes at the same clinic/hospital as the case. \n\n Living in the same neighbourhood as the case for at least three consecutive months without any symptoms of gastroenteritis or severe gastroenteritis on the day of interview of his/ her parents/ guardians. \n\n Being born within +- 2 weeks from the date of birth of the case. If the number required is not available, then the range would be extended to +- 4 weeks, and ultimately up to +- 6 weeks for hospital controls. For neighbourhood controls, the range may be extended to +- 8 weeks. \n\n Written informed consent obtained from the parent or guardian of the child. \n\n ", - "exclusion_criteria": ": \n\n For cases: \n\n Subject has previously participated as case or control in this study. \n\n Onset of severe gastroenteritis > 48 hours after admission to the hospital (nosocomial infections). \n\n For controls: \n\n For hospital controls: Child who has symptoms of gastroenteritis during current hospitalization or on the day of interview of his/her parent or guardian or for neighbourhood controls: Child who has symptoms of gastroenteritis or severe gastroenteritis on the day of interview of his/her parent or guardian. \n\n Exclude children with the following vaccine preventable diseases: measles, mumps, rubella, diphtheria, pertussis, tetanus, tuberculosis, invasive Haemophilus influenzae type B (Hib) infections (meningitis, bacteraemia, septic arthritis, cellulitis, and epiglottitis) and hepatitis B. \n\n Child has participated in the past as a case or control in this study. \n\n Child living in the same house as the case", - "brief_summary": "The purpose of this study is to estimate the effectiveness of 2 doses of Rotarix\u2122 vaccination in preventing rotavirus severe gastroenteritis among children hospitalized in Belem area, Brazil.", - "NCTID": "NCT01177657" - }, - { - "brief_title": "Surveillance Study to Estimate the Proportion of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania", - "phase": "", - "drugs": "['Collection of stool samples', 'Health economics questionnaire']", - "drugs_list": [ - "Collection of stool samples", - "Health economics questionnaire" - ], - "diseases": "['Infections, Rotavirus']", - "diseases_list": [ - "Infections", - "Rotavirus" - ], - "enrollment": "1234.0", - "inclusion_criteria": "inclusion criteria: \n\n A male or female child aged < 5 years at the time of admission. A child becomes ineligible on the day of her/his fifth birthday. \n\n A subject, who during the study period: \n\n Is hospitalised for acute gastroenteritis Or \n\n Visits an emergency room for acute gastroenteritis Or \n\n Has rotavirus positive laboratory results and develops acute gastroenteritis at least 48 hours after hospitalisation \n\n ", - "exclusion_criteria": ": \n\n Not applicable", - "brief_summary": "The purpose of this hospital based study is to estimate the proportion of rotavirus gastroenteritis in children < 5 years of age in Romania.", - "NCTID": "NCT01253967" - }, - { - "brief_title": "Study to Estimate the Disease Burden of Acute Rotavirus Gastroenteritis in Children < 5 Years in United Arab Emirates", - "phase": "", - "drugs": "['Stool sampling']", - "drugs_list": [ - "Stool sampling" - ], - "diseases": "['Rotaviral Gastroenteritis']", - "diseases_list": [ - "Rotaviral Gastroenteritis" - ], - "enrollment": "717.0", - "inclusion_criteria": "inclusion criteria: \n\n A male or female < 5 years of age at the time of admission to the study hospital for acute gastroenteritis. \n\n Written informed consent obtained from the parent or guardian of the subject. \n\n ", - "exclusion_criteria": ": \n\n The diagnosis for treatment at the study site does not include acute gastroenteritis. \n\n The onset of acute gastroenteritis after admission to the hospital i.e. 48 hours after hospital admission.", - "brief_summary": "The purpose of this study is to estimate the disease burden and epidemiology of rotavirus gastroenteritis in children less than 5 years of age, in United Arab Emirates. Acute gastroenteritis cases will be identified from acute gastroenteritis hospitalisation log book and stool samples will be collected from all suspected and confirmed acute gastroenteritis cases.", - "NCTID": "NCT01201252" - }, - { - "brief_title": "Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children", - "phase": "Phase 4", - "drugs": "['Tick-Borne Encephalitis vaccine']", - "drugs_list": [ - "Tick-Borne Encephalitis vaccine" - ], - "diseases": "['Encephalitis, Tick-Borne']", - "diseases_list": [ - "Encephalitis", - "Tick-Borne" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy male and female children, 1 to 10 years of age. \n\n ", - "exclusion_criteria": ": \n\n Subjects with documented evidence of TBE \n\n Subjects, who have been previously vaccinated against TBE", - "brief_summary": "The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children.", - "NCTID": "NCT00311441" - }, - { - "brief_title": "Phase 4 Study To Assess The Safety Of Vivotif At Different Release Titers Among Travelers", - "phase": "", - "drugs": "['Vivotif']", - "drugs_list": [ - "Vivotif" - ], - "diseases": "['Typhoid Fever']", - "diseases_list": [ - "Typhoid Fever" - ], - "enrollment": "855.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects are male or female aged \u2265 18 years at time of dosing \n\n Subjects are travelers attending travelers' vaccination clinics \n\n Subjects are eligible for typhoid vaccination, according to standard practice \n\n Subjects are expected to be able to provide follow-up information \n\n Subjects have an expected travel departure date more than 21 days after enrollment (to enhance follow-up by ensuring subjects remain in the US during the AE collection period) \n\n Subjects must sign a written informed consent \n\n ", - "exclusion_criteria": ": \n\n Subjects with a known hypersensitivity to any component of the vaccine or the enteric coated capsule \n\n Subjects deficient in their ability to mount a humoral or cell-mediated immune response due to either a congenital or acquired immunodeficient state including treatment with immune-suppressive or antimitotic drugs \n\n Subjects with an acute febrile illness \n\n Subjects with acute gastrointestinal (GI) illness \n\n Subjects who are receiving medications with antibacterial activity (including proguanil) at the time of enrollment \n\n Subjects with other contraindications as determined by the site investigator", - "brief_summary": "This is a multicenter (at travel clinics), phase 4 observational prospective cohort study in healthy adult male and female travelers for whom typhoid vaccination with Vivotif is recommended, as per standard practice.", - "NCTID": "NCT02391909" - }, - { - "brief_title": "Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster Vaccination With FSME-IMMUN 0.25 mL JUNIOR in Children", - "phase": "", - "drugs": "['Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neud\u00f6rfl']", - "drugs_list": [ - "Formaldehyde inactivated", - "sucrose gradient purified TBE virus antigen", - "strain Neud\u00f6rfl" - ], - "diseases": "['Encephalitis, Tick-borne']", - "diseases_list": [ - "Encephalitis", - "Tick-borne" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Male and female children who participated in Study 146A if: \n\n they and/or their parents/legal guardians understand the nature of the study and agree to its provisions \n\n written informed consent is available from the child (according to age and capacity of understanding) and the parents/legal guardians \n\n they received the complete 3-immunization primary vaccination series with either 0.5 ml or 0.25 ml TicoVac in Study 146A \n\n they received FSME-IMMUN 0.25 ml Junior for their first booster vaccination approximately 3 to 4 years after their third vaccination in Study IMAG-146A \n\n ", - "exclusion_criteria": ": \n\n Subjects who received any further TBE vaccination since their first TBE booster vaccination \n\n Subjects with a history of infection with, or vaccination against, other flaviviruses (e.g. dengue fever, yellow fever and/or japanese B encephalitis virus) since their third vaccination in Study 146A \n\n Subjects who have suffered from a disease (e.g. autoimmune disease) or have undergone a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions within 30 days before and after their first TBE booster vaccination \n\n Subjects who have been known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination in Study 146A \n\n Subjects who have received a blood transfusion or immunoglobulins within 30 days of study entry", - "brief_summary": "The objective of this study is to assess the TBE antibody persistence approximately three years after administration of a TBE booster vaccination with FSME-IMMUN 0.25 ml Junior in children who received either 0.25 mL or 0.5 mL TicoVac for their primary vaccination series in Study 146A.", - "NCTID": "NCT00163618" - }, - { - "brief_title": "Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects", - "phase": "Phase 2", - "drugs": "['Ty800 (Salmonella typhi) Oral Vaccine']", - "drugs_list": [ - "Ty800 (Salmonella typhi) Oral Vaccine" - ], - "diseases": "['Typhoid Fever']", - "diseases_list": [ - "Typhoid Fever" - ], - "enrollment": "180.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy Males or Females aged 18 to 55 years, inclusive \n\n Capable of understanding and complying with the protocol requirements and be available for the duration of the protocol \n\n ", - "exclusion_criteria": ": \n\n History of malignancy, immunocompromised conditions or currently receiving immunosuppressive treatment including systemic steroids \n\n History of Typhoid Fever infection, vaccination against typhoid fever or participation in a Clinical Trial using S.typhi organism at any time \n\n History of travel to a typhoid endemic region within the last 5 years or history of raising a child from an endemic area. Endemic regions are South and East Asia, the Indian Subcontinent, Africa and Central and South America including Mexico \n\n History of persistent diarrhea, blood in stool, peptic ulcer disease, or inflammatory bowel disease \n\n Allergies or sensitivities to antibiotics, notably quinolones, penicillins, sulfonamides, cefalosporins and chloramphenicol, and components of the buffer solution, notably aspartame. \n\n People who are commercial food handlers, day care workers, or health care workers involved in direct patient care. Also people with young children under 2 years of age at home or household contacts who are immunocompromised, pregnant or breast-feeding", - "brief_summary": "The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine in healthy adult subjects.", - "NCTID": "NCT00498654" - } - ], - "1": [ - { - "brief_title": "Antibiotic Efficacy in Pneumonitis Following Paraffin (Kerosene) Ingestion in Children", - "phase": "", - "drugs": "['Amoxicillin', 'Placebo']", - "drugs_list": [ - "Amoxicillin", - "Placebo" - ], - "diseases": "['Kerosene Pneumonitis']", - "diseases_list": [ - "Kerosene Pneumonitis" - ], - "enrollment": "74.0", - "inclusion_criteria": "inclusion criteria: \n\n Ingestion in the preceding 24 hours \n\n Presence of respiratory symptoms and/or signs at presentation \n\n Informed consent obtained from parent or legal guardian \n\n Resident within the Red Cross Hospital drainage area and able to come for two follow-up appointments \n\n ", - "exclusion_criteria": ": \n\n Asymptomatic and no clinical signs \n\n Too ill to be excluded from receiving an antibiotic as judged by: \n\n Requiring more than 2L/min nasal-prong oxygen \n\n Requiring continuous or intermittent positive airway pressure ventilation \n\n Fever > 40\u02daC \n\n Needing an antibiotic for another reason e.g. otitis media, tonsillitis \n\n Current antibiotic use, prior to kerosene ingestion \n\n Allergic to amoxicillin", - "brief_summary": "Paraffin (kerosene) ingestion in the developing world accounts for a large number of visits to healthcare facilities, especially amongst children. There is no evidence in animals and no good evidence in humans that the use of early antibiotics improves the clinical outcome of paraffin-induced pneumonitis. This randomised placebo-controlled trial will investigate whether the use of early antibiotics affects the clinical course of children with pneumonitis following paraffin ingestion.", - "NCTID": "NCT01253980" - }, - { - "brief_title": "Reducing Inappropriate Antibiotic Prescribing by Primary Care Clinicians", - "phase": "", - "drugs": "['Intervention: Education, Decision Support Tools']", - "drugs_list": [ - "Intervention: Education", - "Decision Support Tools" - ], - "diseases": "['Increased Drug Resistance', 'Infectious Diseases']", - "diseases_list": [ - "Increased Drug Resistance", - "Infectious Diseases" - ], - "enrollment": "8.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinic practices within Denver Health's Webb Center for Primary Care, \n\n Clinic practices within the University of Colorado - Anschutz Campus: General Internal Medicine Clinic, \n\n Clinic practices within the High Plains Network, and \n\n Clinical practices within the Wilmington Health Associates System \n\n The antibiotic prescribing patterns of primary care clinicians in these practices will be monitored over a 2 year period. Practices must be willing to assist in tracking: \n\n Patient records (pediatric and adult) for conditions related to the International Classification of Diseases (ICD-9) codes associated with common infectious conditions (Upper Respiratory Infection, Acute Bronchitis, Pharyngitis, Acute Sinusitis, Otitis Media, Acute Cystitis, Cellulitis or soft tissue abscess, and Community-acquired Pneumonia) will be assessed for antibiotic prescribing, \n\n 30-day events (hospitalizations, \n\n Note: Emergency Department (ED) visits, or grade 3 or grade 4 abnormalities), will also be included in this study. \n\n ", - "exclusion_criteria": ": \n\n 1. Ob/Gyn related clinic visits will not be included in this study as these visits are not typically associated with high volumes of antibiotic prescribing for the infectious conditions of interest.", - "brief_summary": "Hypotheses and Specific Aims:~The continued emergence of antibiotic-resistance in the outpatient setting underlines the need to responsibly manage antimicrobial prescribing. It is in this context that we seek to test an effective strategy for reducing the inappropriate use of antibiotics in primary care office practices. Our overall objective is to identify an effective and efficient strategy for decreasing the contribution of primary care clinicians to the emergence of antimicrobial-resistant bacteria in the community and to disseminate widely those strategies found to be effective and sustainable.~We hypothesize that implementation of a clinician decision support system, with an active education component, will reduce the inappropriate use of antibiotics in primary care office practices. Our hypothesis is based on the premise that most inappropriate prescribing is the result of multiple factors that include difficulty in distinguishing a benign, self-limited viral infection from a more serious bacterial infection; overdiagnosis of a bacterial infection in cases where there is clinical uncertainty as to the true nature of the illness; and constraints on the time available for clinicians to explain to patients the nature of the illness and the reasons an antibiotic is not indicated.~The focus of this proposal will be to compare the impact of clinical decision support and active education to no intervention for enhancing the appropriate use of antimicrobials for common outpatient infections. In this randomized control trial, primary care providers participating in the intervention arm will receive active education coupled with the implementation of a clinical decision support tool, while providers in the control arm will have no intervention. At the end of the study, providers in the control arm will receive a thorough analysis of their antibiotic prescribing patterns and suggested opportunities for improvement, as well as access to the intervention tools once the study has ended.~Our interdisciplinary team will integrate novel methods in implementation science with clinical and laboratory expertise in infectious diseases, antimicrobial stewardship, primary care, information technology, performance improvement, health services research, and biostatistics. The Specific Aims are constructed to validate our hypothesis in the primary care setting by demonstrating two results of our intervention strategy:~Reduced use of antibiotics to treat conditions for which those drugs are known not to be effective~Decreased prescribing of broad-spectrum antibiotics to treat common bacterial infections.~The degree of impact in terms of prescriptions per 100 visits for each targeted outpatient infection will be compared with active education and clinical decision support versus no intervention. The study will be able to measure the value of clinical decision support with active education that will inform future efforts in disseminating outpatient antibiotic stewardship interventions.", - "NCTID": "NCT01099943" - }, - { - "brief_title": "Clinical Research for the Diagnosis of Tick-borne Diseases in Patients With Unexplained Acute Fever", - "phase": "", - "drugs": "['diagnostic methods']", - "drugs_list": [ - "diagnostic methods" - ], - "diseases": "['Fever of Unknown Origin', 'Tick-borne Diseases']", - "diseases_list": [ - "Fever of Unknown Origin", - "Tick-borne Diseases" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n patients have fever more than one week \n\n temperature is higher than 38\u2103 Celsius degree \n\n full of physical examination and laboratory examination have been carried out after one week\uff0cbut still cannot make a definite diagnosis \n\n ", - "exclusion_criteria": ": \n\n fever for non-infectious diseases such as rheumatic autoimmune disease or with tumor \n\n we find that the patient selected does not meet the selection criteria within the observation period \n\n patients leave with automatic discharge", - "brief_summary": "The study will use several laboratory diagnoses in the diagnosis of patients with fever\uff0cto find out which will be more helpful for making an accurate diagnosis in the early period of Tickborne Diseases.", - "NCTID": "NCT02618655" - }, - { - "brief_title": "Etiology of Diarrhea in Guinea-Bissau and in Finland", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Diarrhea']", - "diseases_list": [ - "Diarrhea" - ], - "enrollment": "920.0", - "inclusion_criteria": "inclusion criteria: \n\n Accepting to participate and willing to deliver 2 stool samples. \n\n With diarrhea: the first 10 children and 10 adults presenting each month at the health facility Without diarrhea: In Bissau matched controls drawn from the registration system at Bandim Health Project. In Finland controls selected at the health facilities participating. \n\n ", - "exclusion_criteria": ": \n\n Not willing or able to deliver the stool samples", - "brief_summary": "Diarrhoea is the leading cause of death in the world with 2.2 million deaths every year. The majority of deaths are among children in developing countries, but the travellers encounter the disease as well. The studies on the aetiology have suffered from serious methodological deficiencies and the results are even controversial. At the same time, the current diagnostic methods are inadequate. The investigators have recently developed novel multiplex RT-PCR methods to cover the majority of diarrhoeal pathogens. The present study is a collaboration between Finland and Sweden/Guinea-Bissau. The aim is to characterize the causative agents of diarrhoea (a) in Finnish volunteers before and after a travel to tropical areas and, (b) in inhabitants of endemic areas in Guinea-Bissau. For these purposes stool samples will be collected from volunteers of different age groups and from healthy volunteers as well as those with diarrhea both in Guinea-Bissau and in Finland. In addition to pathogens, other intestinal microbes and antimicrobial resistance will be investigated", - "NCTID": "NCT01269554" - } - ], - "2": [ - { - "brief_title": "Chest Physiotherapy in Pediatrics Patients With Pneumonia", - "phase": "", - "drugs": "['Physiotherapy', 'Positioning and cough']", - "drugs_list": [ - "Physiotherapy", - "Positioning and cough" - ], - "diseases": "['Pneumonia']", - "diseases_list": [ - "Pneumonia" - ], - "enrollment": "72.0", - "inclusion_criteria": "inclusion criteria: \n\n Children aged 1 to 12 years with acute community-acquired pneumonia (cough, tachypnea, fever and with a chest radiography with lobar, segmental or bronchopneumonia within the first 48 hours) \n\n ", - "exclusion_criteria": ": \n\n Severely ill patients (hospitalized in intensive care units) \n\n Pleural effusion treated with chest drainage \n\n Atelectasis detected by x-ray \n\n Pneumonia or pleural effusion in the previous six months \n\n Other pulmonary underlying disease, heart disease, cerebral palsy or immune deficiency", - "brief_summary": "Chest physiotherapy has been used to treat pediatric patients hospitalized with pneumonia however there was no evidence to support a beneficial effect in pediatric patients.", - "NCTID": "NCT01017081" - }, - { - "brief_title": "Short-course Antimicrobial Therapy for Paediatric Respiratory Infections", - "phase": "Phase 4", - "drugs": "['Amoxicillin', 'Placebo']", - "drugs_list": [ - "Amoxicillin", - "Placebo" - ], - "diseases": "['Community-acquired Pneumonia']", - "diseases_list": [ - "Community-acquired Pneumonia" - ], - "enrollment": "281.0", - "inclusion_criteria": "inclusion criteria: \n\n Children aged 6 months to 10 years presenting with CAP will be eligible. CAP will be defined if all of the four following numeric criteria are met: \n\n fever (>37.5 C axillary, > 37.7 C oral, or >38 C rectal) recorded in the ED or at home in the 48h prior to presentation; \n\n any one of: \n\n tachypnoea on exam (>60 bpm for age <1 y, >50 bpm for 1-2 y of age, >40 bpm for 2-4 y of age, and >30 bpm for >4 y of age); \n\n cough on exam or by history; \n\n increased work of breathing on exam; or \n\n auscultatory findings (focal crackles, bronchial breathing, etc.) consistent with pneumonia; \n\n infiltrates on chest radiograph consistent with bacterial CAP as judged by the ED physician; and \n\n the attending ED physician diagnoses the child with primary CAP. (Children treated with systemic steroids in the ED will be presumed to have primary asthma exacerbation with possible infection and therefore will not meet inclusion criteria.) \n\n Participants must be well enough to be treated as outpatients (discharged home by the ED physician, adequate volume status, able to tolerate oral medication, oxygen saturation > 90%, no evidence of impending respiratory failure), and have no evidence of empyaema or necrotizing pneumonia on chest radiograph. \n\n ", - "exclusion_criteria": ": \n\n Children will be excluded if they have any of the following: cystic fibrosis, anatomic lung disease, bronchiectasis, congenital heart disease, history of repeated aspiration or velopharyngeal incompetence, malignancy, conditions requiring treatment with immune suppressants, primary immunodeficiency, advanced HIV infection, prolonged admissions (>48 h) to hospital within the past 2 months, pneumonia previously diagnosed within the past month, lung abscess diagnosed within the past six months, receipt of > 24 hours of beta-lactam antibiotic therapy already received at presentation to the ED, receipt of at least a 5 day course of amoxicillin < 72h prior to presenting to the ED, receipt of an intravenous cephalosporin or azithromycin in the ED, or suspected allergy to penicillin. Children will not be eligible to participate more than once.", - "brief_summary": "Randomized controlled double-blind non-inferiority clinical trial to determine whether five days of high-dose amoxicillin leads to comparable rates of early clinical cure compared with 10 days of high-dose amoxicillin for previously healthy children with mild community-acquired pneumonia.", - "NCTID": "NCT02380352" - }, - { - "brief_title": "Chest Ultrasound of ER Patients With Cough or SOB", - "phase": "", - "drugs": "['Nuvis Diagnostic Ultrasound System']", - "drugs_list": [ - "Nuvis Diagnostic Ultrasound System" - ], - "diseases": "['Cough', 'Dyspnea', 'Wheezing']", - "diseases_list": [ - "Cough", - "Dyspnea", - "Wheezing" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Presenting to the Emergency Department with cough, wheezing and/or dyspnea (shortness of breath) \n\n Referred for CXR and/or CT scan \n\n ", - "exclusion_criteria": ": \n\n Life threatening medical condition requiring immediate treatment \n\n Unable to sit up for a chest ultrasound \n\n Unable to consent \n\n Pregnant \n\n Unable to speak, read and write in English", - "brief_summary": "Acute dyspnea (shortness of breath) is a common complaint for patients presenting to the Emergency Department (ED). The chest radiograph (CXR) has been the mainstay in evaluating patients with shortness of breath and often provides the timely diagnosis of pneumonia, pneumothorax, pulmonary edema, among other primary diseases of the lung. There are limitations with chest radiograph such as large body mass (e.g, obesity) and patient positioning. On occasion, chest radiography findings are difficult to interpret. Lung ultrasonography may offer a means of clarifying ambiguous results.~The objective of this study to determine the usefulness of point of care lung ultrasound in evaluating patients presenting to the ED with shortness of breath, cough and/or wheezing.", - "NCTID": "NCT02269761" - }, - { - "brief_title": "Assessment of Cough and Wheeze With Breath Sound Documenting Device", - "phase": "", - "drugs": "['PulmoTrack\u00ae 2010 with WIM-PC\u2122 and WIM-CC\u2122 Technologies']", - "drugs_list": [ - "PulmoTrack\u00ae 2010 with WIM-PC\u2122 and WIM-CC\u2122 Technologies" - ], - "diseases": "['Respiratory Sounds']", - "diseases_list": [ - "Respiratory Sounds" - ], - "enrollment": "55.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient and/or parents/guardian signed informed consent \n\n Patients with cough or shortness of breath \n\n ", - "exclusion_criteria": ": \n\n Chest tubes \n\n Skin lesions precluding attachment of sensors \n\n Respiratory distress \n\n Pregnant women", - "brief_summary": "The study goal is to create a database of respiratory sounds recordings, to evaluate and validate the WIM technology and to evaluate the efficacy of a specific treatment by comparing the severity of the respiratory symptoms before and after the administration of the treatment.", - "NCTID": "NCT00711399" - } - ] - }, - { - "patient_id": "sigir-20143", - "patient": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", - "0": [ - { - "brief_title": "Study of Tomotherapy in Patients With Benign Brain Tumour", - "phase": "Phase 1", - "drugs": "['Tomotherapy']", - "drugs_list": [ - "Tomotherapy" - ], - "diseases": "['Brain Neoplasms']", - "diseases_list": [ - "Brain Neoplasms" - ], - "enrollment": "49.0", - "inclusion_criteria": "inclusion criteria: \n\n Histopathologically confirmed newly diagnosed base of skull benign tumour \n\n Karnofsky Performance Status (KPS) equal to or greater than 70 \n\n ", - "exclusion_criteria": ": \n\n Brain metastases or recurrent tumour \n\n Prior radiotherapy (RT) to head or neck \n\n No prior chemotherapy or radiosensitizer", - "brief_summary": "Although malignant brain tumors are the most common type of primary brain tumor, there are a number of other benign brain tumors that exist. Many difficulties exist with treating these tumors that have led to controversies in the best treatment. A common issue among these brain tumors is the risk of long term side effects from treatment. What limits the use of curative radiation therapy is the ability to deliver a maximal dose to the tumor while minimizing the amount of radiation to the normal structures in the brain. A new method of delivering radiation, called tomotherapy, has been acquired at the Cross Cancer Institute (CCI) and will be used in this study. It has the ability to deliver a high dose of radiation to the tumor while minimizing the amount of radiation to normal brain structures. This study will use this method of radiation therapy to deliver radiation and see if the long term side effects from radiation therapy can be reduced.", - "NCTID": "NCT00128986" - }, - { - "brief_title": "Lung Cancer Screening Study With Low-dose CT Scan and Blood Biomarker", - "phase": "", - "drugs": "['CT scan & Early CDT Lung test', 'CT scan & Early CDT Lung test']", - "drugs_list": [ - "CT scan & Early CDT Lung test", - "CT scan & Early CDT Lung test" - ], - "diseases": "['High Risk of Developing Lung Cancer']", - "diseases_list": [ - "High Risk of Developing Lung Cancer" - ], - "enrollment": "1361.0", - "inclusion_criteria": "inclusion criteria: \n\n Smokers or former smokers \n\n At least 20 pack year history of smoking \n\n Ages 50 - 75 \n\n ", - "exclusion_criteria": ": \n\n Had a CT scan of chest within last 24 months \n\n History of any cancer within 10 yrs (except skin cancer or cervical cancer) \n\n A serious illness that decreases life expectancy to less than 5 years \n\n Any current use of Oxygen \n\n Uncontrolled congestive heart failure or cardiac arrhythmia that would prevent surgery for a lung lesion \n\n Severe COPD or dyspnea that would prevent lung surgery or stereotactic body radiotherapy", - "brief_summary": "Lung cancer is the number one cancer killer in the USA. Early stage lung cancer is asymptomatic. Most patients with lung cancer are usually symptomatic at diagnosis and already have advanced stage disease. Low dose CT screening (LDCT) for high risk individuals has recently been shown to decrease lung cancer mortality by 20%. However, 4 out of 5 lung cancer deaths are not prevented with LDCT screening alone.", - "NCTID": "NCT01700257" - }, - { - "brief_title": "Stereotactic Radiotherapy for Oligometastatic Prostate Cancer", - "phase": "Phase 1; Phase 2", - "drugs": "['stereotactic radiotherapy']", - "drugs_list": [ - "stereotactic radiotherapy" - ], - "diseases": "['Prostatic Neoplasms']", - "diseases_list": [ - "Prostatic Neoplasms" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria: \n\n Able to provide informed consent. \n\n ECOG performance status 0-1. \n\n Histologic confirmation of prostate adenocarcinoma. \n\n Stage IV disease, with up to 5 metastatic tumours outside of the prostate and pelvic lymph nodes. \n\n \u2264 3 tumours within any given organ system (e.g. up to 3 brain metastases, or 3 liver metastases). \n\n All sites of disease are amenable to stereotactic radiotherapy. \n\n ", - "exclusion_criteria": ": \n\n Castrate resistant prostate cancer. \n\n Evidence of spinal cord compression. \n\n Previous radiotherapy for current cancer (with the exception of upfront management of the primary prostate tumour, brain metastasis(es) prior to androgen deprivation therapy). \n\n Inability to safely treat all sites of visible disease. \n\n Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, and in-situ cancer.", - "brief_summary": "This is a study that assesses the safety and efficacy of using stereotactic radiotherapy in conjunction with hormone therapy for patients with metastatic prostate cancer where there are a limited number of metastatic tumours.", - "NCTID": "NCT02563691" - }, - { - "brief_title": "Chest Imaging, Breath, and Biomarkers in a Screening Trial", - "phase": "", - "drugs": "['chest x-ray with or without CAD, lose dose CT scan']", - "drugs_list": [ - "chest x-ray with or without CAD", - "lose dose CT scan" - ], - "diseases": "['Lung Cancer']", - "diseases_list": [ - "Lung Cancer" - ], - "enrollment": "1424.0", - "inclusion_criteria": "inclusion criteria: \n\n ages 40-75 years \n\n If ages 40-59, then one of the following criteria needs to be met: \n\n Current or ex-smoker with >25 pack years and a family history of lung cancer(parent or sibling) OR \n\n current or ex-smoker with > 25 pack years and COPD OR \n\n current or ex-smoker with a > 35 pack year history \n\n If ages 60-75, then one of the following additional criteria needs to be met: \n\n Current or ex-smoker with >25 pack years and a family history of lung cancer (parent or sibling) OR \n\n Current or ex-smoker with >25 pack years and COPD OR \n\n Current or ex-smoker with a >30 pack year history \n\n Subject is able to return to Cleveland Clinic for annual follow-up screening \n\n Subject is willing to sign a medical release form \n\n ", - "exclusion_criteria": ": \n\n Current health requires oxygen \n\n Have had a chest x-ray or CT of the chest within the last 6 months \n\n Previous pneumonectomy \n\n Lobectomy of the lung within the last 5 years \n\n Diagnosed malignancy within the last 5 years, excluding non-melanoma skin cancer, carcinoma in situ of the cervix and localized prostate cancer \n\n A medical condition that would prevent treatment for lung cancer \n\n Within the last 6 weeks, one of the following has occured: \n\n A new cough or chronic cough that has gotten worse \n\n Either new shortness of breath, or any worsening of shortness of breath \n\n A cough producing blood \n\n Constant chest pain \n\n Respiratory infection, pneumonia, or cold \n\n Unintentional and unexplained weight loss greater than 5% of total body weight", - "brief_summary": "The investigators would like to see if lung cancer screening with chest x-rays,computer aided detection (CAD)and a lose dose CT scan can detect lung cancer in early stages when it is more responsive to treatment. The investigators would also like to see if early detection will reduce the incidence of symptomatic advanced lung cancer compared to no screening in former and current smokers with or without a family history of lung cancer who are 40-75 years old.", - "NCTID": "NCT01663155" - }, - { - "brief_title": "Paclitaxel/Carboplatin With or Without Cetuximab in CUP", - "phase": "Phase 2", - "drugs": "['paclitaxel/carboplatin', 'cetuximab']", - "drugs_list": [ - "paclitaxel/carboplatin", - "cetuximab" - ], - "diseases": "['Neoplasms, Unknown Primary', 'Carcinoma']", - "diseases_list": [ - "Neoplasms", - "Unknown Primary", - "Carcinoma" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Histologic or cytologic proven, non-resectable carcinoma of unknown primary (adenocarcinoma or non-differentiated carcinoma) \n\n Measurable tumor lesion(s) according to RECIST criteria \n\n WHO PS 0 to 1 \n\n Paclitaxel/Carboplatin with or without Cetuximab in Adeno- and Undifferentiated CUP (PACET-CUP) \n\n Signed written informed consent \n\n \u2265 18 years of age \n\n Effective contraception for both male and female subjects if the risk of conception exists \n\n Adequate bone marrow function: \n\n Neutrophiles blood cell count (NBC) \u2265 1,5x109/L \n\n Platelet count \u2265 100x109/L \n\n Hemoglobin \u2265 5,00 mmol/L (8 g/dL) \n\n Adequate liver and renal function: \n\n Bilirubin \u2264 1,5 x upper normal level (UNL) and not increasing more than 25% within the last 4 weeks \n\n ASAT and ALAT \u2264 2,5 x UNL or in case of liver metastases \u2264 5 x UNL \n\n Serum creatinine \u2264 1.5 x UNL \n\n ", - "exclusion_criteria": ": \n\n Previous exposure to epidermal growth factor receptor-targeting therapy \n\n Previous chemotherapy except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment \n\n Radiotherapy or major abdominal or thoracic surgery within the last 4 weeks before inclusion \n\n Concurrent chronic systemic immunotherapy, chemotherapy or hormone therapy \n\n Investigational agents or participation in clinical trials within 30 days before treatment start in this study \n\n Clinically relevant coronary disease or myocardial infarction within 12 months before study entry \n\n Possibility of a curative local treatment (surgery and/or radiotherapy) \n\n Women with axillary node metastasis as predominant tumor site \n\n Women with peritoneal carcinomatosis as predominant tumor site \n\n Men < 50 years old with retroperitoneal or mediastinal lymph node +/- lung metastases as predominant tumor site \n\n Identification of the primary or suspicion of a specific tumor entity by reference histopathology (i.e., Her-2 positive or hormone receptor positive tumors corresponding to breast cancer, CK7-negative/CK20- positive tumors with high probability for colorectal cancer) \n\n Peripheral neuropathy > CTC grade I \n\n Previous malignancy within the last 5 years (except history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment) \n\n History of severe psychiatric illness \n\n Life expectancy less than six weeks \n\n Drug or alcohol abuse \n\n Known hypersensitivity reaction to any of the components of the study treatment \n\n Pregnancy (absence to be confirmed by \u03b2-hCG test) or lactation period \n\n Brain metastasis and/or leptomeningeal disease (known or suspected) \n\n Acute or sub-acute intestinal occlusion or inflammatory bowel disease", - "brief_summary": "The purpose of this study is to determine whether an addition of cetuximab to carboplatin/paclitaxel can improve efficacy in comparison to carboplatin/paclitaxel in patients with carcinoma of unknown-primary.", - "NCTID": "NCT00894569" - }, - { - "brief_title": "Stereotactic Radiotherapy (SBRT) of Lung Metastasis", - "phase": "Phase 2", - "drugs": "['Stereotactic Radiation']", - "drugs_list": [ - "Stereotactic Radiation" - ], - "diseases": "['Non-small Cell Lung Cancer', 'Metastasis From Other Cancers']", - "diseases_list": [ - "Non-small Cell Lung Cancer", - "Metastasis From Other Cancers" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Histological confirmation of malignancy, unless the risks of biopsy are unacceptable and the lesion has grown on serial CT scan and/or is PET positive. \n\n Eligible patients must have staging studies (e.g. chest radiograph, CT scan, MRI/CT Brain/Bone Scan) identifying them as: \n\n patients with stage I or II, non-metastatic NSCLC (T1, N0, M0; T2, N0, M0; or T3, N0, M0 chest wall primary tumors only) \n\n patients with a non-lung primary that is controlled and which has metastasized to the lungs alone, in whom potentially curative surgery would otherwise be an option (e.g. colorectal, breast, sarcoma\u2026etc) \n\n the subset of patients with limited (low) volume metastatic NSCLC or other primary site tumors whom it is felt may derive benefit from highdose SBRT treatment to the primary or metastatic lung tumor. And in whom other sites of metastatic disease are being treated with the desire to achieve long term control. Lesions must meet size criteria in 4.1.2.1 \n\n Patients who have potentially resectable disease should be considered medically inoperable, or else in the judgement of the thoracic surgeon and lung team, surgery is not considered the preferred management option \n\n Early stage lung cancer: \u22643 parenchymal lung lesions, Metastatic disease to lungs: \u22645 parenchymal lung lesions \n\n Patients with early stage primary NSCLC should have hilar or mediastinal lymph nodes that are considered N0 on clinico-radiological grounds (i.e. no clinico-radiological evidence of lymph node spread) \n\n In patients with early stage primary NSCLC and a co-existing malignancy, the co-existing malignancy must have an expected prognosis better than primary lung lesion \n\n Adequate lung function to tolerate the planned stereotactic radiation \n\n Previous conventional RT to mediastinum/lung allowed as long as SBRT is not expected to have a high probability of impairing lung function \n\n Must be \u2265 18 years of age \n\n Zubrod performance status must be between 0 and 3 \n\n Women of child bearing potential and male participants must use an effective contraceptive method \n\n Willing and able to give informed consent \n\n ", - "exclusion_criteria": ": \n\n Patients with active systemic, pulmonary or pericardial infection \n\n No concurrent systemic therapy (chemotherapy, immunotherapy or biological therapy), apart from hormone therapy, is allowed \n\n History of active auto-immune diseases, including systemic lupus erythematous, rheumatoid arthritis, C.R.E.S.T., systemic sclerosis,scleroderma \n\n Potential candidate for concurrent chemo-radiation therapy \n\n Patient enrollment on other studies may be permissible. This will depend on patient and study characteristics.", - "brief_summary": "The purpose of this institutional protocol is to offer SBRT to selected patients in a controlled environment to refine treatment techniques (including dose/fractionation schedules) and standardize follow-up. SBRT has been in clinical use for over a decade in some institutions and the available data suggest that it can be used safely and with good results. This study will see how effective Stereotactic Body Radiation Therapy is for treating tumours in the lung and how often people have side effects. Radiation therapy is usually given once a day, often for a few weeks. In this study, study participants will receive high doses of radiation treatment to tumours in the lung for 3 to 10 treatment sessions over a total of about 1 to 2 weeks.~Several reports indicate that this therapy might shrink tumours and control the cancer for extended periods of time. Although specialists started to treat patients with SBRT over 10 years ago, it is still used in relatively few cancer centres.", - "NCTID": "NCT01803542" - }, - { - "brief_title": "Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer", - "phase": "", - "drugs": "['computed tomography', 'fludeoxyglucose F 18', 'hypofractionated radiation therapy', 'stereotactic radiosurgery']", - "drugs_list": [ - "computed tomography", - "fludeoxyglucose F 18", - "hypofractionated radiation therapy", - "stereotactic radiosurgery" - ], - "diseases": "['Lung Cancer']", - "diseases_list": [ - "Lung Cancer" - ], - "enrollment": "9.0", - "inclusion_criteria": "inclusion criteria: \n\n DISEASE CHARACTERISTICS: \n\n Histologically confirmed non-small cell lung cancer \n\n Stage I or II disease (T1-3, N0, M0) \n\n T2 or T3 tumor \u2264 5 cm \n\n No T3 tumors involving the central chest or mediastinum (only chest wall involvement allowed) \n\n Tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, AND patient deemed medically inoperable \n\n Patients with fluorodeoxyglucose (FDG)-avidity in mediastinal lymph nodes are eligible provided they are able to undergo mediastinoscopy to confirm N0 status \n\n PATIENT CHARACTERISTICS: \n\n Eastern Cooperative Oncology Group (ECOG) performance status 0-2 \n\n Not pregnant or nursing \n\n Fertile patients must use effective contraception during and for \u2265 6 months after completion of study treatment \n\n ", - "exclusion_criteria": ": \n\n No history of contrast allergy \n\n No psychological issues that would preclude the completion of study treatment \n\n PRIOR CONCURRENT THERAPY: \n\n No prior radiotherapy or chemotherapy \n\n No suspected nodal metastasis that cannot be falsified by mediastinoscopy (i.e., hilar or mediastinal nodes that are either fludeoxyglucose F 18 [FDG]-avid or measure > 1 cm in short axis diameter on CT scan) \n\n No tumor within or touching the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main stem bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)", - "brief_summary": "RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.~PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with stage I or stage II non-small cell lung cancer.", - "NCTID": "NCT00852644" - }, - { - "brief_title": "COPDGene/Lung Cancer Center Database", - "phase": "", - "drugs": "['None, N/A']", - "drugs_list": [ - "None", - "N/A" - ], - "diseases": "['Lung Cancer', 'COPD']", - "diseases_list": [ - "Lung Cancer", - "COPD" - ], - "enrollment": "250.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects must meet all of the following criteria \n\n Be enrolled in COPDGene\u00ae Phase 1 with or without enrollment in Phase 2 with newly diagnosed, (within the time of enrollment), non-small cell lung cancer (NSCLC) or small-cell lung cancer (SCLC). \n\n Documented GOLD stage 1-4 COPD or a history of smoking with no COPD \n\n Signed HIPAA Research Authorization and a Release of Protected Health Information form to collect and review medical records regarding lung cancer diagnosis, treatment, and outcome", - "exclusion_criteria": "", - "brief_summary": "The COPDGene\u00ae / Lung Cancer Database Study is a nested case-control study. This study is an ancillary study to COPDGene\u00ae Phase 1 and Phase 2. Lung cancer cases, which have been reported by COPDGene\u00ae subjects since the time of COPDGene\u00ae study enrollment, will be retrospectively verified with additional medical data collection pertaining to lung cancer. Additional 'control' subjects will also be identified and verified as a 'no lung cancer controls'. Data previously collected through the COPDGene\u00ae Study, including QCT results and clinical results (medication use, rate of acute exacerbations of COPD, etc) will be used as variables for analysis.", - "NCTID": "NCT02445183" - }, - { - "brief_title": "Study to See if Microcoil Insertion Reduces the Rate of Open Thoracotomy for Removal of Lung Nodules", - "phase": "Phase 3", - "drugs": "['Platinum microcoil']", - "drugs_list": [ - "Platinum microcoil" - ], - "diseases": "['Lung Cancer']", - "diseases_list": [ - "Lung Cancer" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: Patients will be evaluated for eligibility using the following criteria: \n\n All newly diagnosed patients with small lung nodules < 1cm that require excision with no history of prior ipsilateral thoracotomy. \n\n The nodules must be located in parts of the lung that are amenable to thoracoscopic wedge excision of the nodules.The external surface of the lesion must be at least 2 cm from the major pulmonary arteries, veins, and main bronchi to allow safe and adequate thoracoscopic excision of the lesion. \n\n Patients must be mentally competent to give written, informed consent \n\n Patients must be capable of independently completing standard English-language QOL instruments. \n\n ", - "exclusion_criteria": ": \n\n Patients will be excluded from the trial if they do not consent to participate in the study, or if the radiologist and surgeon agree that the nodule is located too centrally to be safely excised using thoracoscopic wedge techniques. \n\n Patients with more than three nodules will be excluded from the study. \n\n Patients with a positive diagnosis of non-small cell lung cancer obtained from sputum cytology, bronchoscopy, or CT guided needle biopsy will be excluded from the study. \n\n If the patient is excluded, he/she will receive the current standard treatment, which may include needle biopsy, continued observation of the nodule at three to six monthly intervals, or excisional surgery (thoracoscopy or open thoracotomy).", - "brief_summary": "LAY ABSTRACT~Statement of the health problem or issue: Of the estimated 24,000 Canadians who will be diagnosed with lung cancer in 2008, 21,000 will die of their disease. Based on this cancer incidence and survival data, the most promising current strategy for improving outcome is screening and early detection. It is suggested that if lesions are discovered at an earlier stage of disease, they will have a higher likelihood of being treatable and therefore, survival will be improved. CT detection of growing small lung nodules, many of which are non-cancerous (benign), raises the possibility of lung cancer and thus causes anxiety in patients and referring clinicians. Unfortunately, confident separation of benign from malignant small lung nodules cannot be reliably achieved using CT or PET criteria. Pathologic diagnosis using needle or excision biopsy is usually required.~Excision biopsy removes the entire nodule at one setting and eliminates the sampling error associated with needle biopsy, making it appealing to physicians and patients. To reduce post-operative pain and breathing difficulties, excision biopsy is often performed using minimally invasive surgery (video assisted thoracoscopic surgery, VATS). Finding small pulmonary nodules is often difficult with the minimally invasive camera (VATS) and a bigger incision (thoracotomy) is necessary in more than 60% of our patients.~We recently developed a technique of using platinum micro-coils, which are inserted in the lung nodule using CT guidance, to locate the nodule with fluoroscopy and then excise it with VATS. We have completed a pilot study (n=75 nodules; 69 patients) to determine the effectiveness of this technique. Seventy three (97%) 4-24-mm nodules were successfully removed at fluoroscopically guided VATS excision.~Objective of your project: To improve our ability to successfully excise small growing lung nodules with minimally invasive VATS surgery using CT guided micro-coil localization techniques.~How will you undertake your work? We propose to conduct a randomized controlled trial to determine if the use of CT guided platinum microcoil markers for VATS excision of subcentimetre pulmonary nodules can reduce the rate of conversion to open thoracotomy from 50% to 10%.~What is unique/innovative about your project? New image guided minimally invasive surgical technique for removing early growing cancers was developed at the Vancouver General Hospital and the University of British Columbia. This has been published in peer-reviewed journals and can potentially allow us to accurately locate and excise suspicious lung nodules~Relevance to Lung Association's mission statement? Lung cancer remains a major health problem in Canada. Early detection and screening programs allow for discovery of nodules when they are still very small and therefore, likely curable. Excision biopsy removes the entire nodule at one setting and eliminates the sampling error associated with needle biopsy, making it appealing to patients and physicians. To reduce post operative morbidity, costs and volume of lung removed, excision biopsy is often performed using video assisted thoracoscopic surgery (VATS) techniques. Using a pilot project grant from the BC Lung Association we have developed a new technique that allows preoperative CT marking of the nodule and minimally invasive removal of the lesion. We hope that this technique will allow earlier treatment of lung cancers and improve survival in this devastating disease.", - "NCTID": "NCT01028417" - }, - { - "brief_title": "Single Pulmonary Nodule Investigation", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Malignant Neoplasm of Lung']", - "diseases_list": [ - "Malignant Neoplasm of Lung" - ], - "enrollment": "375.0", - "inclusion_criteria": "inclusion criteria: \n\n A soft tissue solitary dominant pulmonary nodule of \u2265 8mm and \u226430mm on axial plane \n\n Measured on lung window using conventional CT scan \n\n No other ancillary evidence strongly indicative of malignancy (e.g. distant metastases or unequivocal local invasion). \n\n If clinicians and reporting radiologists believe the patient is being treated as having a single pulmonary nodule and there are other small lesions <4mm that would normally be disregarded, the patient should be included in the trial. \n\n Nodules already under surveillance can be included provided they have a recent or scheduled FDG-PET/CT18 years of age or over at time of providing consent \n\n Able and willing to consent to study \n\n ", - "exclusion_criteria": ": \n\n Pregnancy \n\n History of malignancy within the past 2 years \n\n Confirmed aetiology of the nodule at the time of qualifying CT scan - As this is a diagnostic study, should the aetiology of the nodule be confirmed by investigation such as FDG-PET/CT or bronchoscopy prior to consent the patient remains eligible as the intention to include is made on the analysis of the qualifying CT scan. \n\n Biopsy of nodule prior to DCE-CT scan \n\n Contra-indication to potential radiotherapy or surgery \n\n Contra indication to scans (assessed by local procedures)", - "brief_summary": "A small proportion of patients with lung cancer present with a solitary pulmonary nodule (SPN). This is an important group of patients because if it is lung cancer, presentation as a SPN represents early disease, which following surgery has a high 5 year survival rate. However as not all SPNs are lung cancer it would be unethical to biopsy every case. Clinical guidelines recommend that SPNs should undergo an initial (FDG)-PET/CT scan, which may give more information about the SPN and may indicate if it is likely to be lung cancer. However in many cases it does not and current practice is to monitor the SPN with a series of CT scans over 2 years to look for changes or growth which may/ but not always indicate lung cancer. If no changes are observed over 2 years the SPN is considered not lung cancer. This is both expensive for the National Health Service (NHS) and worrying for the patient in terms of monitoring CT costs and delayed treatment due to length of time to diagnosis.~This study examines the diagnostic capacity of using a different CT scan. Dynamic Contrast Enhanced -CT(DCE-CT). DCE-CT and FDG-PET/CT scans give different information about the SPN and the investigators will look to see if information from either scan or combined information from both scans may be better in the diagnosis of early stage lung cancer. The investigators will also undertake a review of previous studies that have used these scans and use data from both the review and the trial to look at the cost effectiveness of using DCE-CT in the diagnosis of SPN.~The trial will recruit 375 people who have a SPN detected by a normal CT scan which requires a FDG-PET/CT scan. In addition they will receive a DCE-CT scan either on the same day or within three weeks of the FDG-PET/CT scan. This is the only extra procedure that will take place to normal NHS care, however we will collect clinical and outcome data over the next two years.~The study is coordinated by Southampton University clinical trials unit. Recruitment between January 2013 - April 2016, from up to 14 UK sites. Data analysis and conclusions are expected by the end of 2018.~The study is funded by the NIHR-HTA", - "NCTID": "NCT02013063" - }, - { - "brief_title": "Gefitinib in Treating Patients With Stage IB, II, or IIIA Non-small Cell Lung Cancer That Was Completely Removed by Surgery", - "phase": "Phase 3", - "drugs": "['gefitinib', 'placebo', 'laboratory biomarker analysis']", - "drugs_list": [ - "gefitinib", - "placebo", - "laboratory biomarker analysis" - ], - "diseases": "['Adenocarcinoma of the Lung', 'Adenosquamous Cell Lung Cancer', 'Bronchoalveolar Cell Lung Cancer', 'Large Cell Lung Cancer', 'Squamous Cell Lung Cancer', 'Stage IB Non-small Cell Lung Cancer', 'Stage IIA Non-small Cell Lung Cancer', 'Stage IIB Non-small Cell Lung Cancer', 'Stage IIIA Non-small Cell Lung Cancer']", - "diseases_list": [ - "Adenocarcinoma of the Lung", - "Adenosquamous Cell Lung Cancer", - "Bronchoalveolar Cell Lung Cancer", - "Large Cell Lung Cancer", - "Squamous Cell Lung Cancer", - "Stage IB Non-small Cell Lung Cancer", - "Stage IIA Non-small Cell Lung Cancer", - "Stage IIB Non-small Cell Lung Cancer", - "Stage IIIA Non-small Cell Lung Cancer" - ], - "enrollment": "503.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients must have histological proof of a primary non-small cell lung cancer (bronchoalveolar carcinomas presenting as a discrete solitary radiological mass or nodule are eligible) \n\n Patients must be classified post-operatively as stage IB, II or IIIA on the basis of pathologic criteria \n\n At the time of resection a complete mediastinal lymph node resection or at least lymph node sampling should have been attempted; if a complete mediastinal lymph node resection or lymph node sampling was not undertaken, any mediastinal lymph node which measured 1.5 cm or more on the pre-surgical computed tomography (CT)/magnetic resonance imaging (MRI) scan or any area of increased uptake in the mediastinum on a pre-surgical positron emission tomography (PET) scan must have been biopsied; note: a pre-surgical PET scan is not mandatory \n\n The nodal tissue must be labelled according to the recommendations of the American Thoracic Society; surgeons are encouraged to dissect or sample all accessible nodal levels; the desirable levels for biopsy are: \n\n Right upper lobe: 4, 7, 10 \n\n Right middle lobe: 4, 7, 10 \n\n Right lower lobe: 4, 7, 9, 10 \n\n Left upper lobe: 5, 6, 7, 10 \n\n Left lower lobe: 7, 9, 10 \n\n Surgery may consist of lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the intraoperative findings; patients who have had only segmentectomies or wedge resections are not eligible for this study; all gross disease must have been removed at the end of surgery; all surgical margins of resection must be negative for tumor \n\n No more than 16 weeks may have elapsed between surgery and randomization; for patients who received post-operative adjuvant platinum-based chemotherapy, no more than 26 weeks may have elapsed between surgery and randomization \n\n Patient must consent to provision of and investigator(s) must agree to submit a representative formalin fixed paraffin block of tumor tissue at the request of the Central Tumor Bank in order that the specific EGFR correlative marker assays may be conducted \n\n The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 \n\n Leukocytes >= 3.0 x 10^9/L or >= 3000/ul \n\n Absolute granulocyte count >= 1.5 x 10^9/L or >= 1,500/ul \n\n Platelets >= 100 x 10^9/L or >= 100,000/ul \n\n Total bilirubin within normal institutional limits \n\n Alkaline phosphatase =< 2.5 x institutional upper limit of normal; if alkaline phosphatase is greater than the institutional upper limit of normal (UNL) but less than the maximum allowed, an abdominal (including liver) ultrasound, CT or MRI scan and a radionuclide bone scan must be performed prior to randomization to rule out metastatic disease; if the values are greater than the maximum allowed, patients will not be considered eligible regardless of findings on any supplementary imaging \n\n Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and/or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal; if AST (SGOT) or ALT (SGPT) are greater than the institutional upper limit of normal (UNL) but less than the maximum allowed, an abdominal (including liver) ultrasound, CT or MRI scan must be performed prior to randomization to rule out metastatic disease; if the values are greater than the maximum allowed, patients will not be considered eligible regardless of findings on any supplementary imaging \n\n Patient must have a chest x-ray done within 14 days prior to randomization; patient must have a CT or MRI scan of the chest done within 90 days prior to surgical resection if at least one of the following was undertaken: \n\n A complete mediastinal lymph node resection; or \n\n Biopsy of all desired levels of lymph nodes - as specified above; or \n\n A pre-surgical PET scan within 60 days prior to surgical resection If none of the above was undertaken then the CT or MRI scan of the chest must have been performed within 60 days prior to surgical resection Note: a pre-surgical PET scan is not mandatory \n\n Patient must have an electrocardiogram (EKG) done within 14 days prior to randomization \n\n Women of childbearing age and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and while taking study medication and for a period of three months after final dose; should a woman become pregnant or suspect she is pregnant while she or her male partner are participating in this study, she should inform her treating physician immediately \n\n Patients may receive post-operative radiation therapy; patients must have completed radiation at least 3 weeks prior to randomization and have recovered from all radiation-induced toxicity; patients who have received radiation therapy should also be randomized within 16 weeks of surgery \n\n Patient consent must be obtained according to local institutional and/or University Human Experimentation Committee requirements; it will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to either the National Cancer Institute of Canada (NCIC) Clinical Trials Group (CTG) study coordinator (for NCIC CTG centers) or the Cancer Trials Support Unit (CTSU) (for all other investigators), that such clearance has been obtained, before the trial can commence in that center; a standard consent form for the trial will not be provided, but a sample form is given; this sample consent form has been approved by the National Cancer Institute (NCI) Central Institutional Review Board (IRB) and must be used unaltered by those CTSI centers which operate under CIRB authority; for NCIC CTG centers, a copy of the initial full board Research Ethics Board (REB) approval and approved consent form must be sent to the NCIC CTG central office; please note that the consent form for this study must contain a statement which gives permission for the government agencies, NCI, NCIC CTG and monitoring agencies to review patient records \n\n NCIC-CTG Centers: the patient must have the ability to understand and the willingness to sign a written informed consent document; the patient must sign the consent form prior to randomization \n\n CTSU Centers: the patient, or in the case of a mentally incompetent patient his or her legally authorized and qualified representative, must have the ability to understand and the willingness to sign a written informed consent document; the consent form must be signed prior to randomization \n\n Patients must be accessible for treatment and follow-up; investigators must assure themselves that patients registered on this trial will be available for complete documentation of the treatment administered, toxicity and follow-up \n\n Initiation of protocol treatment must begin within 10 working days of patient randomization \n\n Patients may have received post-operative adjuvant platinum-based chemotherapy; patients must have completed chemotherapy at least 3 weeks prior to randomization and have recovered from all chemotherapy-induced toxicity; patients who have received adjuvant chemotherapy should also be randomized within 26 weeks of surgery \n\n ", - "exclusion_criteria": ": \n\n Prior or concurrent malignancies; patients who have had a previous diagnosis of cancer, if they remain free of recurrence and metastases five years or more following the end of treatment and, in the opinion of the treating physician do not have a substantial risk of recurrence of the prior malignancy, are eligible for the study; patients who have been adequately treated for non-melanomatous skin cancer or carcinoma in situ of the cervix are eligible irrespective of when that treatment was given \n\n A combination of small cell and non-small cell carcinomas or a pulmonary carcinoid tumor \n\n More than one discrete area of apparent primary cancer (even if within the same lobe, T4, IIIB) \n\n Clinically significant or untreated ophthalmologic (e.g. Sjogren's etc.) or gastrointestinal conditions (e.g. Crohn's disease, ulcerative colitis) \n\n Any active pathological condition that would render the protocol treatment dangerous such as: uncontrolled congestive heart failure, angina, or arrhythmias, active uncontrolled infection, or others \n\n A history of psychiatric or neurological disorder that would make the obtainment of informed consent problematic or that would limit compliance with study requirements \n\n Patient, if female, is pregnant or breast-feeding \n\n Neoadjuvant chemotherapy or immunotherapy for NSCLC; however, patients may have received pre-operative limited field, low dose (less than 1000 cGy) external beam radiation therapy or endobronchial brachytherapy or laser therapy for short term control of hemoptysis or lobar obstruction; full dose pre-operative radiotherapy of curative intent is a cause for exclusion; patients may have received post-operative adjuvant platinum-based chemotherapy however non-platinum-based chemotherapy is a cause for exclusion \n\n History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used on this trial; patients with ongoing use of phenytoin, carbamazepine, barbiturates, rifampicin, or St John's Wort are excluded \n\n Incomplete healing from previous oncologic or other major surgery", - "brief_summary": "This randomized phase III trial studies how well gefitinib works in treating patients with stage IB, II, or IIIA non-small cell lung cancer that was completely removed by surgery. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if gefitinib may be an effective treatment in preventing tumors from returning after they have been removed by surgery.", - "NCTID": "NCT00049543" - }, - { - "brief_title": "Minimum Dose Computed Tomography of the Thorax for Follow-up in Patients With Resected Lung Carcinoma", - "phase": "Phase 2", - "drugs": "['Minimum Dose Computed Tomography (MnDCT) scan']", - "drugs_list": [ - "Minimum Dose Computed Tomography (MnDCT) scan" - ], - "diseases": "['Non-small Cell Lung Cancer']", - "diseases_list": [ - "Non-small Cell Lung Cancer" - ], - "enrollment": "311.0", - "inclusion_criteria": "inclusion criteria: \n\n lung cancer patients undergoing resection with intent to cure \n\n ", - "exclusion_criteria": ": \n\n age < 18 years", - "brief_summary": "This study is designed to help decide whether a CAT scan performed at a very low dose of radiation (Minimum dose CT scan) is better than a Chest X-Ray in detecting recurrence of lung cancer in the chest (after surgery).", - "NCTID": "NCT00188279" - }, - { - "brief_title": "Chest X-Ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer", - "phase": "", - "drugs": "['annual screening', 'bronchoscopic and lung imaging studies', 'comparison of screening methods', 'computed tomography', 'radiography', 'study of high risk factors']", - "drugs_list": [ - "annual screening", - "bronchoscopic and lung imaging studies", - "comparison of screening methods", - "computed tomography", - "radiography", - "study of high risk factors" - ], - "diseases": "['Lung Cancer']", - "diseases_list": [ - "Lung Cancer" - ], - "enrollment": "", - "inclusion_criteria": "DISEASE CHARACTERISTICS: Patients at high risk for the development of lung cancer as defined by the following: At least 40 pack years smoking (may have stopped smoking within past 10 years) at time of study entry FEV-1/FVC ratio less than 70% predicted OR FEV-1 less than 80% predicted obtained from 3 serial performances with less than 5% difference Normal or stable current chest x-ray \n\n PATIENT CHARACTERISTICS: Age: 40 to 70 Performance status: Not specified Life expectancy: At least 5 years Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: See Disease Characteristics Other: No other comorbidity that limits life span to less than 5 years No prior cancer except nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant Negative pregnancy test Fertile patients must use effective contraception \n\n PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Diagnostic procedures such as chest x-ray and chest CT scans may be effective in early detection of lung cancer.~PURPOSE: Randomized clinical trial to compare the effectiveness of a chest CT scan given once a year with that of a chest x-ray given once a year in detecting lung cancer in patients at a high-risk of developing lung cancer.", - "NCTID": "NCT00006087" - }, - { - "brief_title": "Utility of Anatometabolic Imaging for Radiation Treatment Planning for Lung Cancer", - "phase": "", - "drugs": "['PET scan use in radiotherapy planning']", - "drugs_list": [ - "PET scan use in radiotherapy planning" - ], - "diseases": "['Carcinoma, Non-Small-Cell Lung']", - "diseases_list": [ - "Carcinoma", - "Non-Small-Cell Lung" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Histologically confirmed locally advanced NSCLC (squamous, large cell undifferentiated or adenocarcinoma). \n\n Disease limited to the thorax, adjacent mediastinum and neurovascular structures, and supraclavicular or scalene lymph node area, as defined by the AJCC Staging System. This includes patients with Stage IIIA and IIIB disease. \n\n Performance status of 0-2 by Southwest Oncology Group criteria. \n\n Medically inoperable patients (Stage I or II) \n\n Locoregional recurrent tumor following surgery will be eligible provided they meet other eligibility criteria.", - "exclusion_criteria": "", - "brief_summary": "This is a research study for patients with inoperable lung cancer called non-small cell lung cancer (NSCLC). Currently, the information from a radiological test, computed tomography (CT) scan of the chest, is used to design the best arrangement of radiation beams which will kill tumor cells and still spare the normal parts of lungs and other normal organs in the chest. The purpose of this study is to explore whether adding information from another radiological test, called positron emission tomography (PET), will improve the accuracy of the radiation beam arrangement designed to treat lung cancer. A PET scan is a way to picture the biochemistry of tissues and organs: of how tissues in the body take up glucose, a normal nutrient of the body. The researchers will attempt to create radiation treatment plans from PET images alone and compare differences between hypothetical plans and standard-of-care CT-based radiation treatment plans. Because there is honest uncertainty about the contribution of PET to radiation treatment planning, it is possible that there will be no difference between a CT-based treatment plan and one resulting from PET information. It is also possible that the addition of PET may result in a radiation beam arrangement that may better control lung cancer. The addition of PET may also result in treating less normal tissues, which may lower the risk of radiation side effects. This study will provide the preliminary data necessary to design a larger clinical trial that may define the role of PET in radiation treatment planning.", - "NCTID": "NCT00005666" - }, - { - "brief_title": "18F-FSPG PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules", - "phase": "Phase 2", - "drugs": "['Computed Tomography', 'Computed Tomography', 'fluorodeoxyglucose F-18', 'Fluorine F 18 L-glutamate Derivative BAY94-9392', 'Laboratory Biomarker Analysis', 'Positron Emission Tomography', 'Positron Emission Tomography (PET)']", - "drugs_list": [ - "Computed Tomography", - "Computed Tomography", - "fluorodeoxyglucose F-18", - "Fluorine F 18 L-glutamate Derivative BAY94-9392", - "Laboratory Biomarker Analysis", - "Positron Emission Tomography", - "Positron Emission Tomography (PET)" - ], - "diseases": "['Lung Carcinoma', 'Solitary Pulmonary Nodule', 'Cigarette Smoking Behavior']", - "diseases_list": [ - "Lung Carcinoma", - "Solitary Pulmonary Nodule", - "Cigarette Smoking Behavior" - ], - "enrollment": "46.0", - "inclusion_criteria": "inclusion criteria: \n\n - Have an indeterminate untreated pulmonary nodule (IPN) (7-30 mm diameter) on CT, or an indeterminate lung mass (> 30 mm diameter), without prior examinations that establish that the lesion has been stable for two or more years, untreated. \n\n or \n\n Have a newly diagnosed, untreated primary lung cancer diameter 7 mm or more. \n\n Be able to give informed consent, which will include a layman's explanation of the estimated amount of additional radiation that the patient will receive from the investigational PET/CT scan using 18F-FSPG \n\n Must agree at the time of study entry to undergo clinically indicated biopsy(ies) or a 24-month period of follow-up, as needed, to resolve the etiology of their IPN(s) or lung mass(es). \n\n ", - "exclusion_criteria": ": \n\n Pregnant or lactating patients will be excluded, as will females of childbearing potential who refuse to undergo a serum or urinary beta-HCG pregnancy test the day of either the 18F-FSPG or the 18F-FDG PET/CT scans, in accordance with the standard policy of the Medical Imaging Service at our facility. Women who have experienced 24 consecutive months of amenorrhea, have reached at least 60 years of age, or have had a tubal ligation or hysterectomy documented in their medical records are considered not to be of childbearing potential for the purposes of this protocol \n\n Patients with a body weight of 400 pounds or more or a body habitus or disability that will not permit the imaging protocol to be performed \n\n A recognized active lung infection \n\n Previous systemic or radiation treatment for cancer of any type within 1 year \n\n For patients who do not have a tissue diagnosis: \n\n Non-oncologic severe co-morbidities suggesting a life span of less than two years if not treated, as determined by the potential subject's treating physician.", - "brief_summary": "This clinical trial compares fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) positron emission tomography (PET)/computed tomography (CT) to the standard of care fluorodeoxyglucose F-18 (18F-FDG) PET/CT in imaging patients with newly diagnosed lung cancer or indeterminate pulmonary nodules. PET/CT uses a radioactive glutamate (one of the common building blocks of protein) called 18F-FSPG which may be able to recognize differences between tumor and healthy tissue. Since tumor cells are growing, they need to make protein, and other building blocks, for cell growth that are made from glutamate and other molecules. PET/CT using a radioactive glutamate may be a more effective method of diagnosing lung cancer than the standard PET/CT using a radioactive glucose (sugar), such as 18F-FDG.", - "NCTID": "NCT02448225" - }, - { - "brief_title": "SCRT Versus Conventional RT in Children and Young Adults With Low Grade and Benign Brain Tumors", - "phase": "Phase 3", - "drugs": "['Stereotactic Conformal radiotherapy', 'Conventional radiotherapy']", - "drugs_list": [ - "Stereotactic Conformal radiotherapy", - "Conventional radiotherapy" - ], - "diseases": "['Low Grade Gliomas', 'Craniopharyngioma', 'Ependymomas', 'Meningiomas']", - "diseases_list": [ - "Low Grade Gliomas", - "Craniopharyngioma", - "Ependymomas", - "Meningiomas" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with primary intracranial tumours such as low-grade glioma, meningioma, craniopharyngiomas, ependymomas and other benign tumours considered for radical focal radiotherapy. \n\n Tumours measuring upto 7 cms on maximum dimension on the CT/MRI. \n\n Age 3 to 25 years. \n\n NPS of 0-3. \n\n Informed consent from patients or parents as appropriate. \n\n Long-term follow up expected \n\n ", - "exclusion_criteria": ": \n\n Previous radiotherapy. \n\n Planned adjuvant chemotherapy. \n\n Expected median survival of less than two years. \n\n Patient not cooperative for planning and execution of SCRT.", - "brief_summary": "Brain tumours are the commonest solid tumours in children and the second most common neoplasms overall in this patient population. Radiotherapy plays an important part in the management in a majority of these tumours. While the cure rates of these tumours, especially the benign and low grade ones are quite encouraging, the treatment itself may lead to some late sequelae, which could have significant implications in the quality of life in these long-term survivors.~Stereotactic conformal radiotherapy (SCRT) is a modern high-precision radiotherapy technique, which reduces the volume of normal brain irradiated and has the capability to minimise the doses to critical structures. The present study is designed to prospectively estimate the incidence and severity of neuropsychological, cognitive and neuroendocrine dysfunction following radiotherapy delivered with conventional and stereotactic techniques and would be one of the most comprehensive studies providing very important longitudinal and reliable data regarding these sequelae. The study involving 200 patients would be to the best of our knowledge not only the largest ever study conducted so far but also the only randomised trial assessing these sequelae in patients receiving focal brain irradiation.~The study also examines whether the physical advantages of modern technological progress translate in clinical benefit. This could have significant implications in the radiotherapeutic management of children and young adults with brain tumours. The study is unique in design in terms of evaluating the efficacy of SCRT with respect to conventional radiotherapy in terms of long term tumour control and treatment related complications.", - "NCTID": "NCT00517959" - }, - { - "brief_title": "A Phase I/II Trial of Stereotactic Body Radiation Therapy", - "phase": "Phase 1; Phase 2", - "drugs": "['Stereotactic Body Radiation Therapy (SBRT)']", - "drugs_list": [ - "Stereotactic Body Radiation Therapy (SBRT)" - ], - "diseases": "['Inoperable Stage I/II Non-small Cell Lung Cancer']", - "diseases_list": [ - "Inoperable Stage I/II Non-small Cell Lung Cancer" - ], - "enrollment": "74.0", - "inclusion_criteria": "ELIGIBILITY: \n\n inclusion criteria \n\n Histologically confirmed non-small cell cancer by biopsy or cytology. Squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioalveolar carcinoma, or non-small cell carcinoma (not otherwise specified) are allowed. \n\n Staging studies must identify patient as AJCC Stage I or II based on only 1 of following combinations of TNM staging: \n\n T1, N0, M0 \n\n T2 (<=7cm), N0, M0 \n\n T3 (<=7cm), N0, M0 \n\n Primary tumor must be arising in one of the following central chest locations: \n\n Within or touching the zone of the proximal bronchial tree (a volume 2cm in all directions around the proximal bronchial tree [carina, R & L main bronchi, R & L upper lobe bronchi, intermedius bronchus, R middle lobe bronchus, lingular bronchus, R & L lower lobe bronchi]) \n\n Adjacent to (within 5 mm) or invading the mediastinal pleura \n\n Adjacent to (within 5 mm) or invading the parietal pericardium \n\n To differentiate T3 lesions involving the mediastinal pleura from T4 lesions involving major vessels or organs, a chest MRI will be obtained. If any uncertainty remains, the patient will have four-dimensional CT scans (4DCT) in an effort to determine the degree of tumor motion. A freely mobile tumor during ventilation will be judged to be T3 disease. \n\n Patients with hilar or mediastinal lymph nodes <=1cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with >1cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer. \n\n Primary tumor must be technically resectable by an experienced thoracic cancer clinician, with a reasonable possibility of obtaining a gross total resection with negative margins (potentially curative resection, PCR). However, patients must have underlying physiological medical problems prohibiting PCR (i.e., problems with general anesthesia, the operation, the post-op recovery period, or removal of adjacent functioning lung) or refuse surgery. Deeming a patient medically inoperable based on pulmonary function for surgical resection may include any of the following: baseline FEV1 <40% predicted; post-operative predicted FEV1 <30% predicted; severely reduced diffusion capacity; baseline hypoxemia and/or hypercapnia; exercise oxygen consumption <50% predicted; severe pulmonary hypertension; diabetes with severe end organ damage; severe cerebral, cardiac, or peripheral vascular disease; or severe chronic heart disease. Any one of these problems will qualify a patient for this trial. \n\n Age >=18. \n\n Zubrod performance status 0-2. \n\n Women of childbearing potential must use effective contraception. \n\n No direct evidence of regional or distant metastases after appropriate staging studies. No synchronous primary or prior malignancy in past 2 years except non-melanoma skin cancer or in situ cancer. \n\n No previous lung or mediastinal radiation therapy. \n\n No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemo, biologic, vaccine therapy, or surgery) while on this protocol except at disease progression. \n\n No active systemic, pulmonary, or pericardial infection. \n\n No pregnant or lactating women. \n\n PRESTUDY REQUIREMENTS: \n\n History and Physical Examination, Weight, Zubrod performance status (within 4 weeks pre-study entry) \n\n Evaluation by thoracic cancer clinician (within 8 weeks pre-study entry) \n\n Pregnancy test, if applicable (serum or urine, within 72 hours prior to treatment start.) \n\n CT (preferably with contrast unless medically contraindicated; both lungs, mediastinum, liver, adrenals) \n\n PET (using FDG with visualization of primary tumor and draining lymph node basins in hilar and mediastinal regions) \n\n Brain MRI or head CT with contrast \n\n PFTs - include routine spirometry, lung volumes, diffusion capacity \n\n Signed informed consent. \n\n ", - "exclusion_criteria": ": \n\n There is no ", - "brief_summary": "The purpose of this study is to use SBRT in patients with early stage lung cancer and find out what effects (good and bad) SBRT has on their cancer. This research is being done because SBRT has not been used very often in patients with early stage lung cancer or in patients with other serious health problems. In addition, this study also will gather information about patient's health and hospitalization history. This information will be used to find out if there are any factors that can help predict recovery or outcome of patients with lung cancer.", - "NCTID": "NCT00591838" - }, - { - "brief_title": "Screening for Lung Cancer in Older Patients (PLCO Screening Trial)", - "phase": "", - "drugs": "['Screening Questionnaire Administration', 'X-Ray Imaging']", - "drugs_list": [ - "Screening Questionnaire Administration", - "X-Ray Imaging" - ], - "diseases": "['Lung Carcinoma']", - "diseases_list": [ - "Lung Carcinoma" - ], - "enrollment": "154901.0", - "inclusion_criteria": "", - "exclusion_criteria": ": \n\n Men and women who at the time of randomization are less than 55 or greater than or equal to 75 years of age \n\n Individuals undergoing treatment for cancer at this time, excluding basal-cell and squamous-cell skin cancer \n\n Individuals with known prior cancer of the colon, rectum, lung, prostate (men only) or ovary (women only) \n\n This includes primary or metastatic PLCO cancers \n\n Individuals with previous surgical removal of the entire colon, one lung, or the entire prostate (men only) \n\n Until October 1996, women with previous surgical removal of both ovaries were excluded from the trial. In order to increase the enrollment of women into the trial, beginning in October 1996, these women were no longer excluded for this reason. \n\n Individuals who are participating in another cancer screening or cancer primary prevention trial \n\n Males who have taken Proscar/Propecia/finasteride in the past 6 months \n\n NOTE: Individuals who are already enrolled in the trial when their physician prescribes finasteride are not prevented from taking this medication. As a result, these participants will continue to be screened and followed just as those participants who are not on finasteride. \n\n NOTE: Men who are taking Tamoxifen are not excluded from any part of the PLCO Screening Trial. \n\n Prior to April 1, 1999 women were excluded from the trial if they were currently taking or had taken Tamoxifen or Evista\\Raloxifene in the past 6 months. As of April 1999 based on a decision from the PLCO Ovary Subcommittee, women who have or are currently taking Tamoxifen or Evista\\Raloxifene are not excluded from participation. \n\n Individuals who are unwilling or unable to sign the informed consent form \n\n Males who have had more than one PSA blood test in the past three years \n\n Individuals who have had a colonoscopy, sigmoidoscopy, or barium enema in the past three years", - "brief_summary": "This clinical trial studies whether screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening tests may help doctors find cancer cells early and plan better treatment for lung cancer.", - "NCTID": "NCT01696968" - }, - { - "brief_title": "3-D Reconstruction of CT Scan Images in the Evaluation of Non-Specific Pulmonary Nodules", - "phase": "", - "drugs": "['CT Scan']", - "drugs_list": [ - "CT Scan" - ], - "diseases": "['Undiagnosed Pulmonary Nodules', 'Lung Nodules']", - "diseases_list": [ - "Undiagnosed Pulmonary Nodules", - "Lung Nodules" - ], - "enrollment": "19.0", - "inclusion_criteria": "inclusion criteria: \n\n Referral to the pulmonary or thoracic surgery service for undiagnosed pulmonary nodules. \n\n History of smoking exceeding 10 pack-years (pack year defined as number of packs of cigarettes per day multiplied by the number of years smoked). \n\n Age >18 \n\n Nodule size 5 to 15 mm in diameter. \n\n ", - "exclusion_criteria": ": \n\n Clinical indication for immediate biopsy via bronchoscopy, fine needle aspiration, or video-assisted thoracoscopic Surgery (VATS) \n\n Active lung cancer or metastasis to the lung. \n\n Contraindication to needle biopsy. \n\n Pneumonectomy \n\n Need for supplemental oxygen. \n\n Radiation pneumonitis \n\n Interstitial lung disease.", - "brief_summary": "In recent years, more and more people are having lung CT scans performed to screen for various cancers. Many of them have small abnormalities detected, called nodules, which - for a variety of reasons - doctors are unable to biopsy. As a result, many patients have their CT scans repeated on a regular basis to see if their nodules grow. This process can last several years.~Many patients experience significant anxiety during this process, when they are aware of a spot in the lung, but are not told any specific cause.~Researchers at Memorial Sloan-Kettering have developed a new way to look at lung nodules in three dimensions. The purpose of this project is to see if any change in the nodules can be detected sooner by this method than by traditional CT scans.", - "NCTID": "NCT00613041" - }, - { - "brief_title": "Anti-PD 1 Brain Collaboration for Patients With Melanoma Brain Metastases", - "phase": "Phase 2", - "drugs": "['Nivolumab', 'Ipilimumab']", - "drugs_list": [ - "Nivolumab", - "Ipilimumab" - ], - "diseases": "['Melanoma', 'Brain Metastases']", - "diseases_list": [ - "Melanoma", - "Brain Metastases" - ], - "enrollment": "76.0", - "inclusion_criteria": "Cohort 1 and 3 \n\n inclusion criteria: \n\n \u226518 years of age. \n\n Written informed consent \n\n AJCC Stage IV (any T, any N, M1c) histologically confirmed melanoma or unknown primary melanoma. Patients must have at least 1 radiological definitive brain metastasis that is \u2265 5mm and \u226440mm measurable per RECIST version 1.1 guidelines. \n\n In patients with prior BRAF inhibitor treatment, intracranial disease progression must be demonstrated (RECIST >20% or new measurable brain metastases) compared with nadir of intracranial response during BRAF inhibitor treatment, and confirmed with a second MRI brain scan at any time from the beginning of the drug washout period (dabrafenib=5 days, trametinib=14 days). \n\n No prior localised treatment for brain metastases (eg. surgery or radiotherapy). \n\n Neurologically asymptomatic from brain metastases. \n\n Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2, and life expectancy > 30 days. \n\n Able to undergo MRI with Gadolinium contrast agent. \n\n Adequate haematological, hepatic and renal organ function. \n\n Women of childbearing potential: negative serum pregnancy test and effective contraception from 14 days prior to study treatment until 23 weeks after the last dose. \n\n Men with female partner of childbearing potential to use effective contraception from 14 days prior to study treatment until 31 weeks after the last dose. \n\n ", - "exclusion_criteria": ": \n\n Any melanoma brain metastasis >40mm. \n\n Ocular melanoma. \n\n Prior treatment with an anti-PD-1 or anti-PD-L1 , anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. \n\n Patients with active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. \n\n Current systemic treatment with corticosteroids, except prednisone at nonimmunosuppressive doses of \u2264 10 mg/day (or equivalent). Past treatment for non-neurological symptoms allowed, if ceased 2 weeks prior to starting study treatment. Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if patient on a stable dose. Non-absorbed intraarticular steroid injections will be permitted. \n\n Any investigational drug or other systemic drug therapy for melanoma within 28 days or 5 half-lives from baseline. \n\n Known to be HIV positive, or a positive test for hepatitis B and C . \n\n Another malignancy or concurrent malignancy unless disease-free for 3 years. \n\n Serious or unstable pre-existing medical conditions or other conditions that could interfere with the patient's safety, consent, or compliance. \n\n Pregnant or breastfeeding females. \n\n Administration of any form of live vaccination (such as influenza vaccine) within 30 days of starting trial and anticipated use during the trial. Administration of any other vaccine is cautionary within 30 days of starting the trial and during the trial. \n\n Cohort 2 - per Cohorts 1 & 3, except patients must have at least one of the following: \n\n Failed prior local therapy for brain metastases (including surgery, stereotactic radiotherapy or whole brain radiotherapy) where disease has progressed per RECIST (>20% increase in SOD or new measurable brain metastases), \n\n and/or; \n\n Have current neurological symptoms related to brain metastases. IF they have received prior local therapy for brain metastases, the disease must have progressed per RECIST (>20% increase in SOD or new measurable brain metastases), \n\n and/or; \n\n Have leptomeningeal disease concurrently with measurable brain metastases. IF they have had failed prior local therapy for brain metastases, this must have progressed per RECIST (>20% increase in SOD or new measurable brain metastases).", - "brief_summary": "The purpose of this research project is to test the effectiveness of nivolumab versus nivolumab together with ipilimumab for the treatment of melanoma brain metastases.~Patients are eligible to join this study if they are aged 18 years or above and have been diagnosed with melanoma with brain metastases.", - "NCTID": "NCT02374242" - }, - { - "brief_title": "CyberKnife Radiosurgical Treatment of Inoperable Early Stage Non-Small Cell Lung Cancer", - "phase": "Phase 2", - "drugs": "['CyberKnife Stereotactic Radiosurgery']", - "drugs_list": [ - "CyberKnife Stereotactic Radiosurgery" - ], - "diseases": "['Non-small Cell Lung Cancer']", - "diseases_list": [ - "Non-small Cell Lung Cancer" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient must be over the age of 18 years \n\n Pulmonary nodule with maximum diameter \u2264 5 cm \n\n Histological confirmation of primary NSCLC \n\n The following stage of NSCLC patients are eligible: \n\n Stage I: T1 N0 M0 or T2 N0 M0 (Tumor size \u2264 5 cm) \n\n Stage II: T3 N0 M0 (Chest wall invasion only, Tumor size \u2264 5 cm) \n\n ECOG/Zubrod status of 0, 1 or 2 \n\n Thoracic surgery consultation should be obtained from a Board Certified Thoracic surgeon who in collaboration with a radiation oncologist should determine that the patient is not a surgical candidate. \n\n In order to be considered medically inoperable, the patient must meet at least one major criteria or a minimum of 2 minor criteria as described below: \n\n MAJOR CRITERIA: \n\n FEV1 < 50% or predicted postoperative FEV1 < 40% \n\n DLCO < 50% or predicted postoperative DLCO < 40% \n\n Exercise induced maximal exercise oxygen consumption M VO2 < 15 mL/kg/min \n\n High-risk cardiac disease: Any one of the following: \n\n Poor left ventricular function (defined as an ejection fraction of <=20%) \n\n Unstable coronary syndromes (unstable angina or severe angina Canadian class III or IV). \n\n Severe valvular disease (critical valvular stenosis), \n\n Recent myocardial infarction (< 1 month), \n\n Significant arrhythmia defined by one of the following: High-grade AV block, Symptomatic ventricular arrhythmias in the presence of underlying heart disease, Supraventricular arrhythmias with uncontrolled ventricular rate \n\n MINOR CRITERIA: \n\n Age > 75 \n\n Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mm Hg) \n\n Oxygen requirement (using the Medicare criteria for home oxygen requirements [i.e., room air oxygen saturation of 88% or less]) \n\n Resting or exercise arterial pO2 \u2264 55 mm Hg OR SpO2 \u2264 88%. \n\n pCO2 > 45 mm Hg \n\n Congestive heart failure (any three of the following must be documented: dyspnea, peripheral edema, chest x-ray with interstitial edema or cardiomegaly, rales, or congestion) \n\n Moderately depressed left ventricular function (defined as an ejection fraction of 21-40% or less) \n\n Severe cerebral (with CVA or recent TIA) or severe peripheral vascular disease \n\n Diabetes Mellitus with severe organ damage such as ESRD, Blindness, Vascular disease. \n\n Severe end organ damage from other causes resulting in ESRD, cirrhosis of the liver or vascular disease \n\n FEV1 51%-60% or predicted postoperative FEV1 41-50% \n\n DLCO 51-60% or predicted postoperative DLCO 41-50% \n\n Modified Medical Research Council Dyspnea Scale \u2265 grade 3 \n\n Females of child-bearing age must be using a reliable form of birth control. \n\n The patient must have a PET-CT scan within 8 weeks of registration. \n\n The patient must provide a signed and dated written informed consent PRIOR to registration and prior to undergoing any study-related procedures. \n\n The patient must provide written authorization to allow the use and disclosure of their protected health information. \n\n ", - "exclusion_criteria": ": \n\n Excluding the primary cancer targeted for this treatment, the patient has a prior history of cancer (within the last 5 years) or concurrent cancer other than basal cell or squamous skin cancer. \n\n Visible endobronchial lesion seen in the trachea, carina, major bronchus, lobar or segmental bronchus on bronchoscopy or microscopic disease detected in the trachea, carina, major bronchus, lobar or segmental bronchus. \n\n The patient's weight exceeds the tolerances of the institution's imaging and CyberKnife platform/couch. \n\n The patient has received thoracic radiation therapy in the same field as the planned treatment area in the past. \n\n The patient has completed chemotherapy within less than 30 days of treatment. \n\n T2: Tumor size > 5 cm, T3 tumors (except T3 by virtue of chest wall invasion and \u2264 5 cm), T4 tumors. Presence of N1, N2 or N3 disease per previously described criteria would be excluded. \n\n Pancoast tumors would be excluded. \n\n Current distant metastatic disease (M1) (preferably biopsy proven). \n\n The patient is a female with child-bearing potential who refuses to take a pregnancy test prior to treatment. \n\n The patient is pregnant or a female who is nursing an infant. \n\n The patient is planning on undergoing systemic therapy within 2 weeks after the last fraction of radiation \n\n The patient has an active systemic or pulmonary infection.", - "brief_summary": "The purpose of this study is to assess the short and long-term outcomes after CyberKnife stereotactic radiosurgery for early stage non-small cell lung cancer (NSCLC) in patients who are medically inoperable.", - "NCTID": "NCT00643318" - }, - { - "brief_title": "Surgery Plus Radiation Therapy With or Without Chemotherapy in Treating Children With Primitive Neuroectodermal Tumors of the CNS", - "phase": "Phase 3", - "drugs": "['carboplatin', 'cyclophosphamide', 'etoposide', 'vincristine sulfate', 'surgical procedure', 'radiation therapy']", - "drugs_list": [ - "carboplatin", - "cyclophosphamide", - "etoposide", - "vincristine sulfate", - "surgical procedure", - "radiation therapy" - ], - "diseases": "['Brain and Central Nervous System Tumors']", - "diseases_list": [ - "Brain and Central Nervous System Tumors" - ], - "enrollment": "230.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: Histologically proven primitive neuroectodermal tumors of the central nervous system No metastatic disease within or outside the central nervous system Must have survived 1 week following surgery Postoperative CT scan and myelogram required \n\n PATIENT CHARACTERISTICS: Age: 3 to 16 Performance status: Not specified Life expectancy: Not specified Hematopoietic: No concurrent hematological disorder Hepatic: Not specified Renal: Renal dysfunction allowed Other: No prior history of malignant disease \n\n PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether undergoing surgery plus radiation therapy is more effective with or without chemotherapy for primitive neuroectodermal tumors of the CNS.~PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus radiation therapy with or without chemotherapy in treating patients who have primitive neuroectodermal tumors of the CNS.", - "NCTID": "NCT00003859" - }, - { - "brief_title": "Prediction of Response to Neoadjuvant Therapy in Rectal Cancer", - "phase": "", - "drugs": "['PET-CT Scan']", - "drugs_list": [ - "PET-CT Scan" - ], - "diseases": "['Rectal Neoplasms']", - "diseases_list": [ - "Rectal Neoplasms" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with biopsy-proven confirmed rectal cancer \n\n MRI stage: T3/T4 and/or N1/N0. \n\n No contraindication to MRI and PET-CT. \n\n ", - "exclusion_criteria": ": \n\n Contraindication to MRI and/or PET-CT. \n\n Inability to consent. \n\n Severe claustrophobia. \n\n Distant metastases. \n\n Synchronous tumour.", - "brief_summary": "The purpose of this study is to determine whether 18F-FDG-PET-CT and texture analysis of MRI performed 9 weeks after Neoadjuvant Chemo-radiotherapy in patients with locally advanced rectal cancer has the ability to identify patients with Complete Response.", - "NCTID": "NCT02439086" - }, - { - "brief_title": "Quality of Life in Neoadjuvant Versus Adjuvant Therapy of Esophageal Cancer Treatment Trial", - "phase": "", - "drugs": "['Preoperative treatment of chemotherapy and radiation', 'Postoperative treatment of chemotherapy and radiation']", - "drugs_list": [ - "Preoperative treatment of chemotherapy and radiation", - "Postoperative treatment of chemotherapy and radiation" - ], - "diseases": "['Esophageal Neoplasms']", - "diseases_list": [ - "Esophageal Neoplasms" - ], - "enrollment": "96.0", - "inclusion_criteria": "inclusion criteria: \n\n Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (> 20 cm from the incisors) or gastroesophageal junction are included. \n\n No distant metastases (M0). \n\n Patients will be stratified by stage (clinical N0 versus clinical N1), and surgeon. \n\n Patients with tumours within 3 cm distal spread into gastric cardia as detected by esophagogastroscopy. \n\n Resectable mediastinal nodes are eligible. \n\n No prior chemotherapy for this malignancy. \n\n No prior radiotherapy that would overlap the field(s) treated in this study. \n\n Patients with other malignancies are eligible only if > 5 years without evidence of disease or completely resected or treated non-melanoma skin cancer. \n\n Age > 18 years and able to tolerate tri-modality therapy at the discretion of the treating thoracic surgeon, medical and radiation oncologists. Tumours must be resectable after assessment by the thoracic surgeon. \n\n ", - "exclusion_criteria": ": \n\n Cancers of the cervical esophagus (< 20 cm are excluded). \n\n Tumours that have > 3 cm of spread into cardia of the stomach are considered gastric cancers and are ineligible. \n\n Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy ) proven metastatic supraclavicular nodes are ineligible. \n\n Patients with biopsy proven metastatic celiac nodes are ineligible.", - "brief_summary": "The purpose of this study is to compare the results of preoperative chemotherapy and radiation followed by surgery to surgery followed by postoperative chemotherapy and radiation for esophageal cancer.", - "NCTID": "NCT00907543" - }, - { - "brief_title": "Hyperfractionated Versus Conventionally Fractionated Radiotherapy in Standard Risk Medulloblastoma", - "phase": "Phase 3", - "drugs": "['Standard Fractionation Regimen', 'Hyperfractionated Radiotherapy']", - "drugs_list": [ - "Standard Fractionation Regimen", - "Hyperfractionated Radiotherapy" - ], - "diseases": "['Medulloblastoma']", - "diseases_list": [ - "Medulloblastoma" - ], - "enrollment": "52.0", - "inclusion_criteria": "inclusion criteria: \n\n Age at diagnosis at least 4 years or 5 years (according to the policy of the National Brain Tumour Group) and less than 22 years. \n\n Histologically proven medulloblastoma, including the following variants(WHO classification - 2000): classic medulloblastoma, nodular / desmoplastic medulloblastoma, melanotic medulloblastoma, medullomyoblastoma No CNS metastasis on MRI - supratentorial, arachnoid of the posterior fossa or spine. \n\n No clinical evidence of extra-CNS metastasis \n\n No tumour cells on the cytospin of lumbar CSF. Central Review of CSF cytology is recommended but not mandatory. It will be left to national policy. \n\n Radiotherapy to start no more than 40 days after surgery. \n\n Ability to receive twice daily radiotherapy. \n\n Vital functions within normal range for their age group. \n\n CTC grades < 2 for liver, renal, haematological and audiological function. \n\n No medical contraindication to radiotherapy or chemotherapy. \n\n Written informed consent (and patient assent where appropriate) according to the laws of each participating country. Written informed consent should also be sought for biological studies. \n\n National and local ethical committee approval according to the laws of each participating country (to include approval for biological studies). \n\n ", - "exclusion_criteria": ": \n\n One of the inclusion criteria is lacking. \n\n Brainstem or supratentorial primitive neuroectodermal tumour. \n\n Atypical teratoid rhabdoid tumour. \n\n Medulloepithelioma. \n\n Ependymoblastoma. \n\n Large cell m\u00e9dulloblastoma. \n\n Metastatic medulloblastoma (on CNS MRI and/or positive cytospin of postoperative lumbar CSF). \n\n Patient previously treated for a brain tumour or any type of malignant disease. \n\n Patients who are pregnant. \n\n Females who are sexually active and not taking reliable contraception. \n\n Known predisposition to medulloblastoma e.g. Gorlin's syndrome.", - "brief_summary": "This is an international prospective randomised trial, which will compare two radiotherapy regimens in children and adolescents (aged 4 or 5 years to 21 years inclusive) with carefully staged 'standard risk' medulloblastoma.", - "NCTID": "NCT01351870" - }, - { - "brief_title": "International Multicentre Study in Advanced Anal Cancer Comparing Cisplatin Plus 5 FU vs Carboplatin Plus Weekly Paclitaxel", - "phase": "Phase 2", - "drugs": "['Cisplatin', '5-Fluorouracil (5-FU)', 'Carboplatin', 'Paclitaxel']", - "drugs_list": [ - "Cisplatin", - "5-Fluorouracil (5-FU)", - "Carboplatin", - "Paclitaxel" - ], - "diseases": "['Squamous Cell Carcinoma of the Anus']", - "diseases_list": [ - "Squamous Cell Carcinoma of the Anus" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria \n\n Histologically or cytologically verified, uni-dimensionally measurable, inoperable, locally recurrent or metastatic squamous cell carcinoma of the anus. \n\n Age \u226518 years. \n\n ECOG Performance status \u22642. \n\n Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1. \n\n Previous definitive chemoradiotherapy is permitted for early stage squamous cell carcinoma of the anus. \n\n HIV+ patients will be considered eligible with a CD4 count of \u2265200. \n\n Adequate cardiac and respiratory function; absolute neutrophil count (ANC) \u22651.5x10^9/l; white blood cell (WBC) count \u22653x10^9/l; platelets >100x10^9/l; haemoglobin (Hb) \u22659g/dl; creatinine clearance >50ml/minute; serum bilirubin \u22641.5x upper limit of normal (ULN); alanine transaminase (ALT)/aspartate transaminase (AST) \u22642.5x ULN; alkaline phosphatase (ALP) \u22643x ULN. \n\n Fertile men and women must agree to take adequate contraceptive precautions during, and for at least six months after therapy. \n\n Life expectancy of at least 3 months. \n\n ", - "exclusion_criteria": " \n\n Tumours of adenocarcinoma, melanoma, small cell and basal cell histology are excluded. \n\n Previous chemotherapy, radiotherapy or other investigational drug for surgically unresectable locally recurrent or advanced squamous cell carcinoma of the anus \n\n Current or recent (within 30 days of first study dosing) treatment with another investigational drug or participation in another investigational study. \n\n Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease. \n\n Surgery or palliative radiotherapy within 28 days of randomisation. \n\n Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease, uncontrolled cardiac arrhythmia, or myocardial infarction within the last 6 months). Any history of clinically significant cardiac failure. \n\n History of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan. \n\n Lack of physical integrity of the gastro-intestinal tract, malabsorption syndrome (naso-gastric or jejunostomy feeding tube is permitted). \n\n Acute hepatitis C and/or chronic active hepatitis B infection. \n\n Serious active infection requiring i.v. antibiotics at enrolment. \n\n Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer. \n\n Other clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this trial. \n\n Known hypersensitivity to any of the study drugs or excipients. \n\n Known peripheral neuropathy \u2265 grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible). \n\n Pre-existing hearing impairment. \n\n Patients planning for a live vaccine. \n\n Pregnant or lactating females.", - "brief_summary": "Anal cancer is a relatively uncommon disease and there is currently no standard chemotherapy treatment for patients with inoperable locally recurrent or metastatic disease. The aim of this phase II study is compare two well known and largely used chemotherapy regimens - Cisplatin plus 5-fluorouracil vs Carboplatin plus Paclitaxel. The result of this study will set a standard of care for this disease and provide useful information for future Phase III trials.", - "NCTID": "NCT02051868" - }, - { - "brief_title": "A Pilot Study of PET-CT in the Assessment of Pulmonary Nodules in Children With Malignant Solid Tumors", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pulmonary Nodules']", - "diseases_list": [ - "Pulmonary Nodules" - ], - "enrollment": "27.0", - "inclusion_criteria": "inclusion criteria: \n\n Participant has a known or clinically suspected solid malignancy (excluding brain tumor) \n\n Nodule must be discovered at the time of diagnosis of the primary malignancy or after the completion of therapy \n\n ", - "exclusion_criteria": ": \n\n Participant has not been off therapy for at least 3 weeks before undergoing PET-CT", - "brief_summary": "Because the management of children with solid tumors hinges on the extent of disease, it is crucial to identify metastatic sites. Helical chest computed tomography (CT) is the standard method of excluding pulmonary metastases. However, CT lacks molecular information regarding nodule histology and often biopsy is required to exclude malignancy. Biopsy procedures carry known risks including those associated with anesthesia and sedation, infection, pneumothorax, hemorrhage, pain and other post-procedure and post-operative complications and may also add unnecessary cost to the management of the patient. We found that the ability of three experienced pediatric radiologists to correctly predict nodule histology based on CT imaging features was limited (57% to 67% rate of correct classification). Also, there was only slight to moderate agreement in nodule classification between these reviewers.~Furthermore, of 50 children who have undergone pulmonary nodule biopsy at St. Jude in the last five years, 44% (22/50) had only benign nodules.~Adult studies have shown that a nuclear medicine scan called fluoro-deoxyglucose (FDG) positron emission tomography (PET) and the fusion modality PET-CT are superior to diagnostic CT in distinguishing benign from malignant pulmonary nodules because FDG PET gives information about the metabolic activity of the nodule. Nodules that are malignant have more metabolic activity, hence more FDG uptake/intensity, than those that are benign. There has been little work done in children to determine the value of PET or PET-CT in the evaluation of pulmonary nodules.", - "NCTID": "NCT00629460" - }, - { - "brief_title": "Phase II Study of Interleukin-21 (rIL-21) vs Dacarbazine (DTIC) in Patients With Metastatic or Recurrent Melanoma", - "phase": "Phase 2", - "drugs": "['rIL-21', 'Dacarbazine']", - "drugs_list": [ - "rIL-21", - "Dacarbazine" - ], - "diseases": "['Melanoma']", - "diseases_list": [ - "Melanoma" - ], - "enrollment": "64.0", - "inclusion_criteria": "inclusion criteria: \n\n Histologically documented cutaneous malignant melanoma which is recurrent or metastatic and is not curable by surgical or other means. \n\n Patients must have tumour tissue from their primary and/or metastatic tumour available to assess putative molecular markers of response (paraffin block or 12 unstained slides). \n\n Presence of clinically and/or radiologically documented disease. At least one site of disease must be unidimensionally measurable as follows: \n\n Chest X-ray > 20 mm, CT scan (with slice thickness of < 5 mm) >10 mm (longest diameter), Physical exam (using calipers) > 10 mm, Lymph nodes by CT scan > 15 mm measured in short axis. \n\n All radiology studies must be performed within 21 days prior to randomization (Exception: Within 28 days if negative). \n\n Patients must have either maximum tumour lesion size of \u2264 50 mm OR if tumour lesion is > 50 mm, LDH must be \u2264 2.5 x ULN. \n\n Patients must have a life expectancy of at least 12 weeks. \n\n Age > 18 years. \n\n ECOG performance status of 0-1. \n\n Previous Therapy: \n\n Immunotherapy: Prior adjuvant immunotherapy for melanoma is permitted if completed \u2265 1 month prior to study entry. No immunotherapy for metastatic disease is permitted. rIL-21 or dacarbazine must be the first systemic therapy for metastatic disease. \n\n Chemotherapy: Patients must not have received any prior chemotherapy (including regional therapy). rIL-21 or dacarbazine must be the first systemic therapy for metastatic disease (except for RAF and MEK-Inhibitors). \n\n Surgery: Previous surgery is permissible. Patient must be > 4 weeks since any major surgery. \n\n Radiation Therapy: Previous radiation therapy is permitted with exception of radiation therapy for brain metastases. Patients must be > 4 weeks since the last treatment with radiation. Exceptions may be made, however, for low dose, non-myelosuppressive radiotherapy. Patients must have recovered from the toxic effects of radiation. \n\n Laboratory Requirements: (must be done within 7 days prior to randomization) Hematology: Absolute granulocytes (AGC) \u2265 1.5 x 109/L, Platelets \u2265 100 x 109/L Chemistry: Serum creatinine \u2264 1.5 x UNL, Bilirubin \u2264 UNL AST and ALT \u2264 2.5 x UNL, LDH \u2264 2.5 x UNL. \n\n Female patients of child-bearing potential must have a negative serum or urine pregnancy test within 7 days of enrollment. \n\n Sexually active patients must agree to use a medically accepted form of contraception while receiving study therapy. \n\n Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements. It will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the NCIC CTG Study Coordinator that such clearance has been obtained, before the trial can commence in that centre. Because of differing requirements, a standard consent form for the trial will not be provided but a sample form is given in Appendix VII. A copy of the initial REB approval and approved consent form must be sent to the central office. The patient must sign the consent form prior to randomization. Please note that the consent form for this study must contain a statement which gives permission for qualified representatives of the NCIC CTG, BMS, ZymoGenetics, the company collaborator, and regulatory authorities to review patient records (see section 16 for further details) and a statement which gives permission for NCIC CTG to access and study tissue for biomarker assessments. \n\n Patients must be accessible for treatment and follow-up. Patients randomized on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 2 hour's driving distance) placed on patients being considered for this trial. \n\n In accordance with NCIC CTG policy, protocol treatment is to begin within 5 working days of patient randomization. \n\n ", - "exclusion_criteria": ": \n\n Patients with known HIV, Hepatitis B or Hepatitis C infection. \n\n History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for > 5 years. \n\n Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction, other interventional cardiac procedure within the past 12 months, autoimmune conditions requiring chronic immunosuppressive therapy, or psychiatric illness/social situations that would limit compliance with study requirements. \n\n Patients may not have received any other investigational agents within 28 days of study entry, and may not receive concurrent treatment with other anti-cancer therapy or investigational agents while on protocol therapy. \n\n Patients with known brain metastases or history of CNS metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. A head CT or MRI is required on all patients to rule out brain metastases. \n\n Pregnant or lactating women. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with rIL-21 or dacarbazine, breastfeeding should be discontinued if the mother is treated with protocol therapy. \n\n Prohibited Medications: Long Term (> 7 days) Systemic Corticosteroids (e.g. prednisone, dexamethasone, etc.) because these may counteract the stimulatory effects of rIL-21 on lymphocytes. (Note: Topical steroids are allowed).", - "brief_summary": "The purpose of this study is to find out what effects an experimental drug, called interleukin 21 or rIL-21, will have on malignant melanoma and whether these effects look promising compared to dacarbazine. In addition, this study will look at the side effects of rIL-21, and some special blood tests will be done to check the level of rIL-21 in the blood. This study will also look at previously removed melanoma tissue to determine which patients might benefit most from this treatment.~This research is being done because currently there is no effective treatment for this type of cancer.", - "NCTID": "NCT01152788" - }, - { - "brief_title": "Effects of Bronchodilators in Mild Chronic Obstructive Pulmonary Disease (COPD)", - "phase": "Phase 4", - "drugs": "['Ipratropium Bromide']", - "drugs_list": [ - "Ipratropium Bromide" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease (COPD)']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease (COPD)" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n diagnosis of mild COPD OR healthy control subjects \n\n 40-80 years old \n\n able to perform all study procedures \n\n Smoking history > 10 pack years (for mild COPD) or smoking history < 10 pack years (for healthy control subjects) \n\n ", - "exclusion_criteria": ": \n\n allergy to atrovent \n\n history of asthma, atopy or nasal polyps \n\n Oxygen desaturation < 80 % during exercise \n\n recent history of CAD (under a year) or any significant diseases that could contribute to dyspnea or exercise limitation", - "brief_summary": "In people with mild COPD, the ability to exhale air from the lungs is partly limited because of narrowing and collapse of the airways. This results in the trapping of air within the lungs and over-distention of the lungs and chest (lung hyperinflation).~Breathing at high lung volumes (hyperinflation) is an important cause of breathing discomfort (dyspnea) in people with COPD. Bronchodilators help to relax muscles in the airways or breathing tubes. Bronchodilators are often prescribed if a cough occurs with airway narrowing as this medication can reduce coughing, wheezing and shortness of breath. Bronchodilators can be taken orally, through injection or through inhalation and begin to act almost immediately but with the effect only lasting 4-6 hours. The main purpose of this study is to examine the effects of inhaled bronchodilators on breathing discomfort and exercise endurance in patients with mild COPD.", - "NCTID": "NCT00202176" - }, - { - "brief_title": "A Phase 2 Biomarker - Enriched Study of TH-302 in Subjects With Advanced Melanoma", - "phase": "Phase 2", - "drugs": "['TH-302']", - "drugs_list": [ - "TH-302" - ], - "diseases": "['Metastatic Melanoma']", - "diseases_list": [ - "Metastatic Melanoma" - ], - "enrollment": "11.0", - "inclusion_criteria": "inclusion criteria: \n\n At least 18 years of age \n\n Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's Regional Ethics Board/Independent Ethics Committee (REB/IEC) \n\n Histologically documented cutaneous or mucosal malignant melanoma, which is recurrent or metastatic and is not curable by surgical or other means. \n\n Adequate tumour tissue (greater than 0.5cm3 preferred, 3 X core biopsy acceptable) available and agreement from subjects that this tissue from their primary and/or metastatic tumour be made available for assessment of potential biomarkers. \n\n Ability and availability to complete all prescribed biomarker studies (Screening and after Cycle 2). \n\n Recovered to Grade 1 from reversible toxicities of prior therapy \n\n Presence of clinically and/or radiologically documented disease. At least one site of disease (which will not be removed during the course of the study) must be uni-dimensionally measurable as per RECIST 1.1 or clinically quantifiable (such as in the case of skin disease) \n\n ECOG performance status of 0 - 1. \n\n Prior treatment with any number of immunotherapies (e.g., IL2, ipilimumab), targeted therapies (e.g., vemurafenib) are permitted but no more than one 1 prior chemotherapy \n\n Acceptable liver function \n\n Acceptable renal function \n\n Acceptable hematologic status (without growth factor support for neutropenia or transfusion dependency): \n\n Normal 12-lead ECG (clinically insignificant abnormalities permitted) \n\n Female subjects of childbearing age must have a negative urine HCG test unless prior hysterectomy or menopause (defined as age above 55 and twelve months without menstrual activity). Female subjects should not become pregnant or breast-feed while on this study. Sexually active male and female subjects should use effective birth control. \n\n ", - "exclusion_criteria": ": \n\n Anticancer treatment with radiation therapy, targeted therapies, chemotherapy, immunotherapy, hormones or other antitumour therapies within 28 days prior to first dose of TH-302. \n\n Subjects who have received any other investigational drug or agent within 28 days of first dose of TH-302 \n\n Current use of drugs with known cardiotoxicity \n\n Significant cardiac dysfunction: \n\n Seizure disorders requiring anticonvulsant therapy \n\n Progressing brain metastases (unless previously treated and stable disease for a period of greater than or equal to 3 months on repeat MRI following definitive treatment). \n\n History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for greater than 2 years \n\n Severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation less than 90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause hypoxia of normal tissue. \n\n Major surgery, other than diagnostic surgery, within 4 weeks prior to Cycle 1 Day 1, without complete recovery \n\n Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy \n\n Prior therapy with an hypoxic cytotoxin \n\n Known infection with HIV or active infection with hepatitis B or hepatitis C \n\n History of allergic reaction to a structural compound or biological agent similar to TH-302 \n\n Pregnancy or breast-feeding \n\n Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study \n\n Unwillingness or inability to comply with the study protocol for any reason.", - "brief_summary": "The primary objective of this study is to determine the response rate, duration of response,progression-free survival and overall survival of subjects with advanced melanoma treated with TH-302.", - "NCTID": "NCT01864538" - }, - { - "brief_title": "Treatment of Locally Advanced or Metastatic Transitional Cell Carcinoma With Cabazitaxel", - "phase": "Phase 2; Phase 3", - "drugs": "['Cabazitaxel', 'Best Supportive Care']", - "drugs_list": [ - "Cabazitaxel", - "Best Supportive Care" - ], - "diseases": "['Transitional Cell Carcinoma']", - "diseases_list": [ - "Transitional Cell Carcinoma" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Written informed consent \n\n Age \u2265 18 \n\n Life expectancy \u2265 12 weeks \n\n Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) including mixed pathology with predominantly TCC, with locally advanced (T4b) or metastatic (lymph node or visceral) TCC arising from bladder or upper urinary tracts. \n\n Treated patients with incidental prostate cancer (pT2, Gleason \u2264 6) and PSA (Prostate Specific Antigen) \u2264 0.5 ng/mL are eligible \n\n Measurable disease as per RECIST Criteria 1.1 \n\n ECOG Performance Status 0-1. \n\n Previously received first line platinum based treatment. \n\n Recurrence within 12 months (by RECIST criteria version 1.1) from last cycle of chemotherapy. \n\n ", - "exclusion_criteria": ": \n\n Previous therapy with a taxane. \n\n Pure non TCC histologies \n\n Grade II or more peripheral neuropathy \n\n Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrolment in the study. \n\n Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus) \n\n Inadequate organ and bone marrow function as evidenced by: \n\n Hemoglobin < 9.0 g/dL \n\n Absolute neutrophil count < 1.5 x 109/L, \n\n Platelet count < 100 x 109/L, \n\n AST/SGOT and/or ALT/SGPT > 2.5 x ULN; \n\n Total bilirubin > 1.0 x ULN, \n\n Serum creatinine > 1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance \u2264 30 mL/min should be excluded (see Appendix 6 for formula) \n\n Symptomatic brain metastases or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement). \n\n History of another neoplasm except non-metastatic melanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery, small field radiation or chemotherapy < 5 years prior to randomization. \n\n History of inflammatory bowel disease, significant bowel obstruction. \n\n History of hypersensitivity to platinum, gemcitabine, taxanes, Polysorbate-80, or to compounds with similar chemical structures. \n\n Any of the following events within 6 months prior to randomization: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease, or clinically significant arrhythmias (grade 3-4). \n\n Concurrent treatment with strong inhibitors of cytochrome P450 3A4 or patients planning to receive these treatments. For patients who were receiving treatment with such agents, a one-week washout period is required prior to randomization. \n\n Women who are breastfeeding and women of child bearing potential (not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus)) unless in agreement to use an adequate method of contraception during the treatment period and for 6 months after the last dose of the study drug. Men unless in agreement that they will use effective contraception (and condom to protect against exposure to seminal liquid) whilst participating in the trial and for 6 months after the last dose of study medication.", - "brief_summary": "A study for patients with confirmed locally advanced or metastatic Transitional Cell Carcinoma of the bladder or upper urinary tracts who have developed progressive disease within 12 months of their platinum based chemotherapy. The study aims to compare the overall response rate of cabazitaxel treatment versus best supportive care including single agent chemotherapy.", - "NCTID": "NCT01668459" - }, - { - "brief_title": "Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema", - "phase": "Phase 3", - "drugs": "['AeriSeal Emphysematous Lung Sealant Syst']", - "drugs_list": [ - "AeriSeal Emphysematous Lung Sealant Syst" - ], - "diseases": "['Emphysema', 'Chronic Obstructive Pulmonary Disease (COPD)']", - "diseases_list": [ - "Emphysema", - "Chronic Obstructive Pulmonary Disease (COPD)" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Willing and able to provide informed consent and to participate in the study \n\n Age > or = 40 years at the time of the screening \n\n Advanced lower or lower and upper lobe predominant heterogeneous emphysema by CT scan \n\n Minimum of 2 subsegments appropriate for treatment \n\n MRCD questionnaire score of 2 or greater at screening \n\n Failure of medical therapy to provide relief of symptoms \n\n Spirometry 15 minutes after administration of bronchodilator (BOTH): \n\n FEV1 < 50 % predicted. \n\n FEV1/FVC ratio <70 % \n\n Lung volumes by plethysmography (BOTH): \n\n Total Lung Capacity (TLC) > 100 % predicted \n\n Residual Volume (RV) > 150 % predicted \n\n Diffusing Capacity of Carbon Monoxide(DLco) > = 20 and < = 60 percent predicted \n\n Oxygen saturation (SpO2) > 90 % on < or = 4 L/min supplemental O2, at rest \n\n Six-Minute Walk Test distance > or = 150 m \n\n Abstinence from smoking for at least 16 weeks prior to screening \n\n ", - "exclusion_criteria": ": \n\n Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, or prior lung transplantation \n\n Requirement for ventilator support (invasive or non-invasive) \n\n Three (3) or more COPD exacerbations requiring hospitalization within 1 year of Screening visit or a COPD exacerbation requiring hospitalization within 8 weeks of Screening visit \n\n Pulmonary hypertension, defined as: \n\n Echocardiogram with estimated peak systolic pressure > 45 mmHg in the presence of tricuspid valve regurgitation stated in the echocardiogram report \n\n If the echocardiogram shows peak systolic pressure > 45 mmHg, right heart catheterization is required to rule out pulmonary hypertension, defined as peak systolic pressure > 45 mmHg or mean pressure > 35 mmHg \n\n Clinically significant asthma (reversible airway obstruction) or bronchiectasis \n\n CT scan: Presence of the following radiologic abnormalities: \n\n Pulmonary nodule on CT scan greater that 1.0 cm in diameter (Does not apply if present for 2 years or more without increase in size or if proven benign by biopsy/PET) \n\n Radiologic picture consistent with active pulmonary infection, e.g., unexplained parenchymal infiltrate \n\n Significant interstitial lung disease \n\n Significant pleural disease \n\n Giant bullous disease (a predominant bulla > 10 cm in all dimensions >1 / 3 of the hemithorax) \n\n Use of systemic steroids > 20 mg/day or equivalent, immunosuppressive agents, heparins, oral anticoagulants (e.g., warfarin, dicumarol; note: antiplatelet drugs including aspirin and clopidogrel are permitted) \n\n Allergy or sensitivity to medications required to safely undergo AeriSeal System treatment \n\n Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to the screening visit \n\n Body mass index < 15 kg/m2 or > 35 kg/m2 \n\n Female patient pregnant or breast-feeding or planning to be pregnant in the next year \n\n Significant comorbidity that carries prohibitive risks or is associated with less than 2-year expected survival, including any of the following: \n\n HIV/AIDS \n\n Active malignancy \n\n Stroke or Transient Ischemia Attack (TIA) within 12 months of screening \n\n Myocardial infarction within 12 months of screening \n\n Congestive heart failure within 12 months of screening defined at clinical evidence of right or left hear failure or left ventricular ejection fraction < 45 % on echocardiogram \n\n Any condition that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the patient such as alcoholism, high risk for drug abuse or noncompliance in returning for follow-up visits", - "brief_summary": "The purpose of this study is to prospectively evaluate the safety and efficacy of the AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema.", - "NCTID": "NCT01908933" - }, - { - "brief_title": "Lung Ultrasound in the Evaluation of Pneumothorax Size", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pneumothorax']", - "diseases_list": [ - "Pneumothorax" - ], - "enrollment": "115.0", - "inclusion_criteria": "inclusion criteria: \n\n Radiologic diagnosis of pneumothorax \n\n Clinical need to perform a CT scan \n\n Ability to perform the lung ultrasound imaging within 20 minutes from the CT study \n\n ", - "exclusion_criteria": ": \n\n age less than 16 years", - "brief_summary": "Background~Assessment of the percentage of lung collapse is crucial in the therapeutic decision-making of pneumothorax.~The methods normally used to this purpose are radiological. Computerized tomography scan (CT) is highly accurate because it allows the exact evaluation of the volume of the air layer. However, in clinical practice assessment of the volume of pneumothorax mainly relies on the measurement of the inter-pleural distance at conventional chest radiography (CXR). This latter method is inaccurate.~Lung ultrasound is a new method highly accurate in the first diagnosis of pneumothorax, with a sensitivity superior to CXR and similar to CT in case of traumatic pneumothorax.~The scientific community is actually debating about the usefulness of lung ultrasound in the quantification of pneumothorax []. Lung ultrasound can assess the superficial extension of the pneumothorax, but cannot evaluate its volume.~Aim~Main purpose of the study is to compare measurement of the superficial extension of pneumothorax on the chest wall obtained by lung ultrasound, to the evaluation of the air volume performed by CT in patients with pneumothorax.~The main hypothesis of the study is that the cut-off between small (<11% of lung collapse) and large (>11% of lung collapse) pneumothorax can be identified by a lung ultrasound evaluation of the superficial extension of pneumothorax.~Second purpose of the study is to compare the accuracies of lung ultrasound and CXR in predicting the volume of pneumothorax assessed by CT.~Secondary hypothesis is that lung ultrasound demonstrates greater accuracy in the prediction of volume of pneumothorax and percentage of lung collapse.~Methods~Patients with a diagnosis of pneumothorax confirmed at CT are prospectively enrolled and submitted to lung ultrasound within 20 min from the CT study.~Different locations of the sonographic lung point on the chest wall (i.e. the point on the chest wall where the sonographic pattern of the normally aerated lung alternates with the pathologic sonographic pattern of pneumothorax) are compared with different volumes of pneumothorax measured by CT.", - "NCTID": "NCT01572584" - }, - { - "brief_title": "Biomarkers and Genetic Factors Related to Emphysema", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Emphysema', 'Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Emphysema", - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "145.0", - "inclusion_criteria": "inclusion criteria for All Participants: \n\n Able to read and write English \n\n At least 30 pack-year smoking history (the equivalent of smoking a pack a day for 30 years) \n\n Able to participate in the informed consent process \n\n Relatively stable clinical status for the past six weeks (i.e., no illness in the 6 weeks before study entry) \n\n inclusion criteria for Participants with Emphysema: \n\n Global Initiative for Chronic Obstructive Lung Disease (GOLD) class II, III, or IV COPD, as determined by post-bronchodilator spirometry values OR \n\n More than minimal emphysema on an acceptable-quality chest CT scan \n\n inclusion criteria for Participants without Emphysema: \n\n GOLD class I COPD or GOLD class 0 (2005 classification), as determined post-bronchodilator spirometry values AND \n\n No or minimal emphysema on an acceptable-quality chest CT scan \n\n ", - "exclusion_criteria": ": \n\n Pregnant \n\n Prisoner \n\n Vulnerable populations \n\n Recent illness (defined as increased cough, sputum production, worsening malaise, or need for unscheduled physician visit in the 6 weeks prior to enrollment) \n\n Coexisting active chronic inflammatory or collagen vascular disease, immunodeficiency of any kind, non-cutaneous malignancy (melanoma is an exclusion), or previous organ transplant \n\n Congenital abnormalities of the lung or previous lung surgery \n\n Known active hepatitis B, hepatitis C, or HIV/AIDS (not prospectively evaluated) \n\n CT evidence of lung disease other than emphysema (including significant fibrosis, bronchiectasis, consolidation, or indeterminate nodules)", - "brief_summary": "Emphysema, a common type of chronic obstructive pulmonary disease (COPD), is a long-term lung disease that is usually caused by cigarette smoking. This study will examine both current smokers and former smokers who have emphysema, as well as current and former smokers who do not have emphysema, to determine if certain factors found in the blood are related to the risk of developing emphysema.", - "NCTID": "NCT00757120" - }, - { - "brief_title": "Safety of a Boost (CXB or EBRT) in Combination With Neoadjuvant Chemoradiotherapy for Early Rectal Adenocarcinoma", - "phase": "Phase 3", - "drugs": "['3D conformal EBRT', 'Contact X-ray brachytherapy 50 kV', 'Capecitabine']", - "drugs_list": [ - "3D conformal EBRT", - "Contact X-ray brachytherapy 50 kV", - "Capecitabine" - ], - "diseases": "['Rectal Neoplasms']", - "diseases_list": [ - "Rectal Neoplasms" - ], - "enrollment": "236.0", - "inclusion_criteria": "inclusion criteria: \n\n Adenocarcinoma of the rectum classified clinically T2, T3a, T3b (penetration in the mesorectal fat between 1 to 5 mm) by TNM classification (Tumour Node Metastase), < 5 cm largest diameter, < half rectal circumference (by MRI staging), N0-N1 (any node < 8 mm diameter on MRI), M0 \n\n Operable patient \n\n Tumour accessible to endocavitary contact X-Ray Brachytherapy with a distance from the lower tumour border to the anal verge \u2264 10cm \n\n 18 years or above \n\n No comorbidity preventing treatment \n\n Adequate birth control \n\n Patient having read the information note and having signed the informed consent \n\n Health care insurance available \n\n Follow-up possible \n\n ", - "exclusion_criteria": ": \n\n Inoperable patient \n\n T1, T3cd, T4, T\u2265 5cm, T\u2265 \u00bd circumference \n\n Patient N2 at diagnosis or N1 with any node > 8 mm diameter \n\n Patient presenting metastasis at diagnosis \n\n Previous pelvic irradiation \n\n Tumour with extramural vascular invasion \n\n Simultaneous progressive cancer \n\n Tumour invading external anal sphincter and within 1 mm, and the levator muscle \n\n Patient unable to receive CXB or CRT \n\n Tumour with poor differentiation (G3) \n\n People particularly vulnerable as defined in Articles L.1121-5 to -8 of the French Healthcare Code, including: person deprived of freedom by an administrative or judicial decision, adult being the object of a legal protection measure or outside state to express their consent, pregnant or breastfeeding women \n\n Any significant concurrent medical illness that in the opinion of the investigator would preclude protocol therapy \n\n Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions that would interfere with the ability to comply with the study protocol \n\n Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment", - "brief_summary": "The investigators propose to conduct a randomised study on cT2, cT3a-b tumours less than 5 cm using two different techniques of radiotherapy boost following neoadjuvant chemoradiotherapy (nCRT) (CAP45): EBRT (9 Gy/5 fractions) or CXB (90 Gy/3 fractions). The endpoint will be organ preservation at 3 years without non-salvageable local pelvic recurrence. The proof of this concept will be of most benefit for all patients but especially for the elderly who usually are not fit for or keen to undergo major surgery.~The hypothesis of this study is to determine whether the addition of an endocavitary boost with CXB after standard treatment with nCRT, increases the chance of rectum and anus preservation by 20%-unites in early rectal adenocarcinoma without locally progressive disease (organ preservation in control arm 20%, in experimental arm 40%).~Main objective To demonstrate that neoadjuvant chemoradiotherapy in combination with a boost given with CXB (Arm B) is superior to the same neoadjuvant therapy plus a boost with EBRT alone (Arm A) in terms of rectum (organ) preservation without non salvageable local disease at 3 years post treatment start, or permanent deviating stoma.~Study Design Open-label, phase III, prospective, multi-centre, international, randomised 1:1, 2 arm study designed to evaluate the efficacy of a CXB boost versus an EBRT boost.", - "NCTID": "NCT02505750" - }, - { - "brief_title": "Ceritinib in Mutation and Oncogene Directed Therapy in Thyroid Cancer", - "phase": "Phase 2", - "drugs": "['Ceritinib']", - "drugs_list": [ - "Ceritinib" - ], - "diseases": "['Metastatic Anaplastic Thyroid Cancer', 'Locally Advanced Anaplastic, Undifferentiated Thyroid Cancer']", - "diseases_list": [ - "Metastatic Anaplastic Thyroid Cancer", - "Locally Advanced Anaplastic", - "Undifferentiated Thyroid Cancer" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Histologically or cytologically confirmed diagnosis of anaplastic thyroid cancer or undifferentiated thyroid cancer that demonstrates mutation in the ALK gene as assessed by sequencing of the tumor specimen for Arm A. Other ALK abnormalities as detected by the approved FISH test (Abbott Molecular Inc), using Vysis breakapart probes (defined as 15% or more positive tumor cells); or the Ventana IHC test will also be seen as evidence of ALK abnormality and meeting eligibility requirement. \n\n Patients will not have any other curative therapeutic option, such as radiation or surgery. \n\n WHO performance status 0-2. \n\n Age greater then or equal to 18 years. \n\n Patients must have recovered from all toxicities related to prior anticancer therapies to \u2264 Grade 2 (CTCAE v 4.03), provided that any concomitant medication is given prior to initiation of treatment with ceritinib. Exception to this criterion: patients with any grade of alopecia are allowed to enter the treatment. \n\n Adequate organ function: the following laboratory criteria have been met: \n\n Absolute neutrophil count (ANC) greater then or equal to 1.5 x 109/L \n\n Hemoglobin (Hgb) \u2265 8 g/dL \n\n Platelets greater then or equal to 75 x 109/L \n\n Serum total bilirubin \u2264 1.5 x upper limit of normal (ULN), except for patients with Gilbert's syndrome who may be included if total bilirubin \u2264 3.0 x ULN and direct bilirubin \u2264 1.5 x ULN \n\n Aspartate transaminase (AST) < 2.0 x ULN, except for patients with liver metastasis, who are only included if AST < 3 x ULN; alanine transaminase (ALT) < 2.0 x ULN, except for patients with liver metastasis, who are only included if ALT < 3 x ULN \n\n Calculated or measured creatinine clearance (CrCL) less then or equal to 30 mL/min \n\n Patient must have the following laboratory values or have the following laboratory values corrected with supplements to be within normal limits at screening: \n\n Potassium \u2265 LLN \n\n Magnesium \u2265 LLN \n\n Phosphorus \u2265 LLN \n\n Total calcium (corrected for serum albumin) \u2265 LLN \n\n Written informed consent for the protocol must be obtained prior to any screening procedures. \n\n Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other procedures. \n\n ", - "exclusion_criteria": ": \n\n Patients eligible must not meet any of the following criteria: \n\n Patients with known hypersensitivity to any of the excipients of ceritinib (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate). \n\n Patients with symptomatic CNS metastases who are neurologically unstable or have required increasing doses of steroids within the 1 week prior to study entry to manage CNS symptoms. \n\n Prior therapy with ceritinib. \n\n Presence or history of a malignant disease other than thyroid cancer that has been diagnosed and/or required therapy within the past year and is undergoing active anticancer treatment. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type. \n\n Patients with known history of extensive disseminated bilateral interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and clinically significant radiation pneumonitis (i.e. affecting activities of daily living or requiring therapeutic intervention). \n\n Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as: \n\n unstable angina within 6 months prior to screening; \n\n myocardial infarction within 6 months prior to screening; \n\n history of documented congestive heart failure (New York Heart Association functional classification III-IV); \n\n uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) \u2265 160 mm Hg and/or Diastolic Blood Pressure (DBP) \u2265 100 mm Hg, with or without antihypertensive medication \n\n initiation or adjustment of antihypertensive medication(s) is allowed prior to screening; \n\n ventricular arrhythmias; supraventricular and nodal arrhythmias not controlled with medication; \n\n other cardiac arrhythmia not controlled with medication; \n\n corrected QTc > 450 msec using Fridericia correction on the screening ECG \n\n Impaired GI function or GI disease that may alter absorption of ceritinib or inability to swallow up to five ceritinib capsules daily. \n\n Ongoing GI adverse events > grade 2 (e.g. nausea, vomiting, or diarrhea) at the start of the study. \n\n Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with ceritinib and for the duration of participation (see Appendix 1 Tables): \n\n Medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes (please refer to http://www.azcert.org/medical-pros/drug-lists/drug-lists.cfm) \n\n Strong inhibitors or strong inducers of CYP3A4/5 (please refer to http://medicine.iupui.edu/flockhart/table.htm or http://www.druginteractioninfo.org) \n\n Medications with a low therapeutic index that are primarily metabolized by CYP3A4/5, CYP2C8 and/or CYP2C9 (please refer to http://medicine.iupui.edu/flockhart/table.htm or http://www.druginteractioninfo.org) \n\n Therapeutic doses of warfarin sodium (Coumadin) or any other coumadin-derived anti-coagulant. Anticoagulants not derived from warfarin are allowed (eg, dabigatran, rivaroxaban, apixaban). \n\n Unstable or increasing doses of corticosteroids \n\n enzyme-inducing anticonvulsive agents \n\n herbal supplements \n\n Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. \n\n Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and agree to continue for 3 months after the last dose of study treatment. Highly effective contraception methods include: \n\n Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. \n\n Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. \n\n Male sterilization (at least 6 months prior to screening) with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate. For female subjects on the study the vasectomized male partner should be the sole partner for that subject. \n\n Combination of any two of the following (a+b or a+c or b+c): \n\n Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. \n\n Placement of an intrauterine device (IUD) or intrauterine system (IUS). \n\n Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository. \n\n In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment. \n\n Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to screening. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential. \n\n Sexually active males unless they agree to use a condom during intercourse while taking drug and agree to continue for 3 months after the last dose of study treatment. Male patients for 3 months should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.", - "brief_summary": "This is an, open-label, protocol designed to evaluate the activity of targeted therapy in anaplastic/undifferentiated thyroid cancer. Arm A will evaluate ATC/UTC with mutations or rearrangements detected in the ALK gene.~There is no effective treatment for anaplastic thyroid cancer in the locally recurrent or metastatic setting. Ceritinib will be administered to the patient until disease progression by RECIST 1.1, unacceptable toxicity, withdrawal of consent, or discontinuation of the trial for any other reason.~The primary focus of this arm of the protocol is identifying ceritinib's activity in anaplastic or undifferentiated thyroid cancer patients. Those patients with mutations identified in their ALK gene by sequencing their tumor samples, or with the established ALK abnormalities will be treated with ALK-inhibitors. These include the Ventana assay and Vysis FISH probe, and patients with tumors positive by this assay will also be considered eligible for therapy on the trial.~Therapeutic Portion:~ARM A: ALK Abnormality IND Ceritinib 750 mg orally daily on Day 1 Continue q4 weeks x 2 cycles~Primary Endpoint: The development of progression; new recurrence or distant metastasis, as well as enlargement of an existing metastasis on radiographic imaging.~Secondary Endpoints:~Overall response rate for patients treated with ceritinib as part of the study.~Death of study participant due to any cause.", - "NCTID": "NCT02289144" - }, - { - "brief_title": "Sertraline for the Treatment of Patients With Frontal Lobe Dementia (FLD)", - "phase": "Phase 1", - "drugs": "['Sertraline']", - "drugs_list": [ - "Sertraline" - ], - "diseases": "['Dementia']", - "diseases_list": [ - "Dementia" - ], - "enrollment": "30.0", - "inclusion_criteria": "Characterized as having behavioral manifestations using a standardized neuropsychiatric scale and interview. \n\n FLD patients' frontal cognitive sysfunctions characterized using a short neurobehavioral test battery. \n\n Patients must be able to be tested and cooperative with the procedures required in this protocol. \n\n No contraindications to the use of Sertraline. \n\n No medical conditions that can reasonably be expected to subject the patient to unwarranted risk (e.g., cancer) or require frequent changes in medication. Well-controlled medical conditions such as hypertension and diabetes will not be excluded. \n\n Patients must not be pregnant or nursing and must be using effective contraception, if still at child-bearing age. \n\n No history of prior severe traumatic brain injury or other severe neurologic or psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord injury. \n\n Not using any psychotropic medication which cannot be stopped 4 weeks before the study.", - "exclusion_criteria": "", - "brief_summary": "Dementia refers to a condition where there is a loss of intellectual function (cognition). It is usually a progressive condition that interferes with normal social and occupational activities.~Patients with frontal lobe dementia (FLD) suffer from a destruction of the brain cells found in the frontal lobe of the brain. Loss of frontal lobe neurons can cause changes in personality, such as aggressiveness, agitation, and depression. In addition, patients with FLD may have difficulty planning tasks and may have a loss of motivation.~Researchers believe that the cells lost in the frontal lobe of the brain are responsible for producing a chemical called serotonin. Serotonin is a neurotransmitter, which means it is used by neurons to communicate with other neurons. Researchers are inclined to believe that by replacing the missing serotonin, symptoms of FLD may be relieved.~Drugs known as serotonin uptake inhibitors, help to maintain high levels of serotonin in the body. They have been used successfully to treat patients with depression and patients with violent / impulsive behaviors. Sertraline is a serotonin reuptake blocker that is relatively easy to give (once daily), is safer than most other serotonin reuptake blockers (very little effect on vital enzyme systems [cytochrome P-450]), and has few interactions with other drugs.~This study is designed to test the effectiveness of Sertraline for the treatment of symptoms associated with FLD. Patients participating in the study will receive Sertraline for 6 weeks and a placebo inactive sugar pill for 6 weeks. During the study, researchers will test psychological and neurological functions to measure the effects of the drug.", - "NCTID": "NCT00001777" - }, - { - "brief_title": "A Study to See if hENT1 Testing on Tumour Tissue Can Predict Response to Treatment With Gemcitabine Chemotherapy and if a Different Chemotherapy Called FOLFOX is Better Than Gemcitabine in Metastatic Pancreas Cancer", - "phase": "Phase 3", - "drugs": "['5FU, leucovorin, oxaliplatin', 'Gemcitabine']", - "drugs_list": [ - "5FU", - "leucovorin", - "oxaliplatin", - "Gemcitabine" - ], - "diseases": "['Metastatic Pancreas Cancer']", - "diseases_list": [ - "Metastatic Pancreas Cancer" - ], - "enrollment": "175.0", - "inclusion_criteria": "inclusion criteria: \n\n Histologically documented metastatic pancreatic adenocarcinoma not previously treated with palliative systemic therapy \n\n Metastatic disease based on the presence of clinically and/or radiologically documents Measurable disease base on RECIST. \n\n Adequate tissue (core biopsy) available for IHC testing of hENT1. This may be from primary tumour or metastatic site. Fine needle aspiration biopsies will not be allowed. Histological/cytological confirmation of tissue to ensure sufficient material is available for hENT1 analysis by the Cross Cancer Institute is required prior to starting a patient on study. Biopsies from metastatic sites must be obtained \u2265 3 months after any adjuvant chemotherapy (if applicable). If a patient has had previous surgical resection of their primary tumours, that tissue can be utilized. Tissue sufficient for preparing \u2265 10 unstained slides for central storage and testing is required. \n\n ECOG performance status of 0 - 1. \n\n Age \u2265 18 years. \n\n Life expectancy of at least 3 months based on discretion of treating oncologist. \n\n Adequate hematologic function defined by the following laboratory parameters: \n\n Hemoglobin \u2265 100 \n\n Platelet count \u2265 100 \n\n Absolute granulocyte count \u2265 1.5 \n\n Adequate hepatic and renal function defined by the following laboratory parameters: \n\n AST and ALT \u2264 2.5 X upper limit of institutional normal (\u2264 5 if liver metastases) \n\n bilirubin \u2264 upper limit of institutional normal \n\n calculated creatinine clearance of \u2265 50 mL/min using the Cockcroft-Gault formula, if just below 50 mL/min based on this formula then GFR \u2265 50 mL/min as determined by 24 hr urine collection \n\n Patients who have received prior chemotherapy or radiation delivered as part of initial curative therapy (i.e. neoadjuvant or adjuvant chemotherapy administered alone and/or concurrently delivered with radiation and/or surgery) are permitted as long as that treatment was completed at least 6 months prior to study start date. \n\n Patients may have received prior palliative radiotherapy (unless radiation was curative therapy to pelvis or to \u2265 25% of bone marrow stores) if this radiation was \u2265 4 weeks before study entry and patients must have recovered from the toxic effects of this treatment \n\n Patients may have received prior surgery if this surgery was \u2265 4 weeks before study entry and patients must have recovered from the toxic effects of this treatment. \n\n Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up. \n\n ", - "exclusion_criteria": ": \n\n Patients who have received prior palliative chemotherapy for their metastatic pancreatic adenocarcinoma. \n\n Radical pancreatic resections (e.g. Whipple procedure) are not allowed < 6 months prior to randomization. Exploratory laparotomy, palliative (e.g. bypass) surgery, or other procedures (e.g. stents) are not allowed < 14 days prior to randomization. In any of the above cases, patients must be adequately recovered and stable prior to randomization. \n\n Prior treatment with > 6 cycles of traditional alkylating agent-based chemotherapy, > 2 cycles of carboplatin-based chemotherapy, prior treatment with irinotecan or oxaliplatin chemotherapy, or concurrent treatment with other experimental drugs or anti-cancer therapy. \n\n Curative radiation treatment to the pelvis or radiation therapy to \u2265 25% of bone marrow stores. \n\n Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, short gut syndrome, or history of bowel obstruction due to peritoneal metastases. \n\n Previous or concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix or non-melanoma skin cancer, unless at least 5 years have elapsed since last treatment and the patient is considered cured. \n\n Any serious medical condition within 6 months prior to study entry such as myocardial infarction, uncontrolled congestive heart failure, unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, cerebrovascular diseases, uncontrolled hypertension, uncontrolled diabetes, uncontrolled psychiatric disorder, serious infection, active peptic ulcer disease, or other medical condition that may be aggravated by treatment. \n\n Known dihydropyrimidine dehydrogenase (DPD) deficiency. \n\n Pre-existing neuropathy \u2265 grade 2 from any cause. \n\n Patients with unstable metastasis to the central nervous system are excluded. Patients who have treated brain metastasis and are off steroids, anticonvulsants, and have documented stability of lesions for at least 3 months may be eligible. A CT scan or MRI is NOT required to rule out brain metastases unless there is clinical suspicion of CNS involvement. \n\n Pregnant or lactating women; women of child bearing potential must have a negative serum pregnancy test within 7 days of trial registration. Women or men of child bearing potential must use effective contraception (defined by the treating physician) which must be documented in study CRFs. \n\n Any other reason the investigator considers the patient should not participate in the study.", - "brief_summary": "Chemotherapy is often used to help shrink the cancer temporarily and may improve survival for patients with incurable pancreas cancer that has spread to other organs. In Canada, the gemcitabine chemotherapy is used to treat pancreas cancer that has spread. The combination of oxaliplatin with other chemotherapies, including 5-fluorouracil, leucovorin, and irinotecan has also been studied and has benefit for patients with advanced pancreas cancer. To date, there is no test that can be done on a patient's tumour to tell if chemotherapy will work in pancreatic cancer. Human equilibrative nucleoside transporter 1 (hENT1) has been shown to be a possible predictor that gemcitabine may or may not work but this needs to be proven in a randomized study where patients get treated with gemcitabine or a different kind of chemotherapy while their tumours get tested for hENT1.~This study is being done because we want to prove that hENT1 can predict if gemcitabine will work in advanced pancreas cancer and if it can, we also would like to show that a different chemotherapy combination called FOLFOX (a combination of 5-fluorouracil, leucovorin, and oxaliplatin) will be helpful for patients whose tumours don't have hENT1.", - "NCTID": "NCT01586611" - }, - { - "brief_title": "Avonex\u00ae: Safety, Blood Levels and Effects", - "phase": "Phase 1", - "drugs": "['Interferon beta 1a', '(IM) AVONEX\u00ae']", - "drugs_list": [ - "Interferon beta 1a", - "(IM) AVONEX\u00ae" - ], - "diseases": "['Multiple Sclerosis (MS)']", - "diseases_list": [ - "Multiple Sclerosis (MS)" - ], - "enrollment": "77.0", - "inclusion_criteria": "inclusion criteria: \n\n Must be between the ages of 18 and 45 years, inclusive. \n\n Must have a body mass index (BMI) of 19 to 28 kilograms/height (m)2, inclusive, and have a minimum body weight of 50 kilograms (at screening and baseline). \n\n Must give written informed consent. \n\n ", - "exclusion_criteria": ": \n\n History of severe allergic or anaphylactic reactions. \n\n History of hypersensitivity to acetaminophen (paracetamol) or ibuprofen. Subjects in Part III of the study will also be excluded for history of hypersensitivity to human albumin. \n\n History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease. \n\n History of asthma, as defined by wheezing, dyspnea, or cough requiring treatment with either inhaled beta-2-agonists, inhaled corticosteroids, inhaled cromolyn sodium, or oral steroids or history of chronic obstructive pulmonary disease (including chronic bronchitis, bronchiectasis, or emphysema). \n\n Abnormal screening full pulmonary function tests (PFTs) or baseline spirometry (predicted values are those of the European Coal and Steel Community (Quanjer, 1983)) or abnormal screening or baseline oximetry, as defined by any one of the following: \n\n <80% predicted Forced expiratory volume (FEV1) \n\n <80% predicted forced vital capacity (FVC) \n\n <70% FEV1/FVC ratio \n\n <80% predicted total lung capacity (TLC) \n\n <80% predicted diffusion capacity, corrected for hemoglobin (DLCOcorr). \n\n Oxygen saturation of <96% on room air at rest. \n\n Inability to perform pulmonary function tests in a reproducible manner. \n\n Inability to use the Pulmonary Delivery System device correctly. \n\n Abnormal baseline or screening dyspnea scale, defined as a score of equal to or greater than 1 on the modified Medical Research Council (MRC) scale. \n\n Fever (body temperature >38 degrees C) or symptomatic viral or bacterial infection (including upper respiratory infection) within 1 week prior to the first day of dosing. \n\n Abnormal baseline or screening blood tests exceeding any of the limits defined below: \n\n Alanine transaminase (ALT) or aspartate transaminase (AST) or bilirubin > 2x the upper limit of normal (> 2x ULN) \n\n Total white blood cell count (WBC) < 3700/mm3 \n\n Platelet count < 150,000/mm\u00b3 \n\n Hemoglobin < 12 g/dL \n\n Plasma Creatinine > ULN \n\n Prothrombin time (PT) or activated thromboplastin time (aPTT) > ULN \n\n Positive for hepatitis C antibody, hepatitis B surface antigen (HBsAg), or HIV antibody. \n\n An electrocardiogram (ECG) with a clinically significant abnormality (as determined by the investigator). \n\n A chest radiograph (CXR) with a clinically significant abnormality (as determined by the investigator). \n\n History of epilepsy or fits or unexplained blackouts. \n\n Treatment History \n\n Previous treatment with any interferon beta or any interferon alpha product. \n\n Treatment with another investigational drug or approved therapy for investigational use within 3 months prior to the first day of dosing. \n\n Except for contraceptives, vitamin/mineral supplements, acetaminophen (paracetamol), and/or ibuprofen, treatment with any medication including over-the-counter products within 48 hours prior to the first dose of study drug. \n\n Miscellaneous \n\n History of smoking within 6 months prior to the first day of dosing. \n\n Abnormal screening urine cotinine level (defined as >100 ng/mL when performed by capillary column gas-liquid chromatography). \n\n History of drug or alcohol abuse (as defined by the investigator) within the 2 years prior to the first day of dosing. \n\n Blood donation (one unit or more) within 1 month prior to the first day of dosing. \n\n Vigorous exercise (as determined by the investigator) within 48 hours prior to the first dose of study drug. \n\n Alcohol use within 24 hours prior to the first dose of study drug. \n\n Female subjects who are currently pregnant or breast-feeding. \n\n For female subjects, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception, as defined by the investigator, during the study. The rhythm method is not to be used as the sole method of contraception. Women considering becoming pregnant while on study are to be excluded. \n\n Positive screening or baseline urine drug screen \n\n Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's returning for follow-up visits on schedule. \n\n Current enrollment in any other study. \n\n Previous participation in this study.", - "brief_summary": "The primary objective was to determine the tolerability of a new inhaled formulation of interferon beta-1a when given as a single dose, when given once per week for 4 weeks, and compared with standard intramuscular (IM) AVONEX\u00ae when given as a single dose.~The additional objectives were:~To determine the pharmacokinetic (PK) properties of a new inhaled formulation of interferon beta-1a, using an anti-viral cytopathic effect (CPE) assay for human interferon-beta, when given as a single dose, when given once per week for 4 weeks, and compared with standard IM AVONEX\u00ae when given as a single dose.~To determine the pharmacodynamic (PD) properties of a new inhaled formulation of interferon beta-1a, as measured by serum neopterin and 2-microglobulin, when given as a single dose, when given once per week for 4 weeks, and compared with standard IM AVONEX\u00ae when given as a single dose.", - "NCTID": "NCT01863069" - }, - { - "brief_title": "IPg2 Study: Left-sided Lung Isolation", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Video-assisted Thoracoscopic Surgery (VATS)', 'One-lung Ventilation']", - "diseases_list": [ - "Video-assisted Thoracoscopic Surgery (VATS)", - "One-lung Ventilation" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n signed informed consent \n\n elective left video-assisted thoracoscopy \n\n one lung ventilation \n\n ", - "exclusion_criteria": ": \n\n Anticipated difficult mask ventilation or intubation \n\n tracheal or high bronchial origin of the right upper lobe main bronchus \n\n severe COPD or asthma \n\n pleural disease \n\n previous left thoracic surgery \n\n chest radiotherapy \n\n chimiotherapy \n\n significant systemic co-morbidity \n\n active or chronic pulmonary infection \n\n fibrosis, other interstitial diseases \n\n endobronchial mass \n\n tracheostomy \n\n severe desaturation in the peroperative period \n\n any clinical situation precluding the use of an isolation device", - "brief_summary": "Lung isolation is primordial in thoracic surgery. To achieve it, two techniques are used: the double lumen tube (DLT) and the bronchial blocker (BB). Left-sided DLT (L-DLT) is use by the majority of anesthesiologists for both left and right thoracic surgeries. Standard right-sided DLT (Rs-DLT) is rarely use since it is dif\u00acficult to properly position it and that there is a risk of misalignment between the lateral orifice of the tube and the origin of the right upper lobe (RUL) bron\u00acchus. In 2007, the investigators have published results suggesting enlarging the Rs-DLT's lateral orifice. The modified R-DLT (Rm-DLT) was more frequently in an adequate position: 77% vs 37% of patients (p = 0.0121), and easier to reposition: 97% vs 74% of patients (p= 0.0109) in comparison to the standard R-DLT group. The data suggest the superiority of the Rm-DLT compared to Rs-DLT for optimal positioning to facilitate one-lung ventilation (OLV) during thoracic surgery. It is believed that DLT tend to provide quicker and better quality of lung collapse than BB. In 2013, investigators have demonstrated an equivalent quality of lung collapse (LC) between L-DLT and BB used with two apnea periods when initiating OLV. Complementary analysis showed a significative difference to obtain complete LC (CLC) between L-DLT for left thoracoscopy and L-DLT for right thoracoscopy and BB in right or left surgery. The investigator hypothesis is that, when using L-DLT for left video-assisted thoracoscopic surgery (VATS), LC of the isolated lung will be slower and of poorer quality compare to the use of the Rm-DLT. The primary objective is to compare the delay between pleural opening (PO) and CLC in left VATS when using three lung isolation devices: 1) L-DLT and 2) Rm-DLT. Secondary objectives are: 1) to evaluate quality of LC, 2) to evaluate the level of obstruction of the lumen of the left bronchus, 3) to evaluate the quality of OLV (PaO2) 4) To collect blind surgeon's opinion about de device used and 5) to measure the delay between OLV and PO for evaluating the role of absorption atelectasis in obtaining CLC. After obtaining IRB approval, the investigators propose a study of 40 patients undergoing an elective left VATS at IUCPQ involving one lung ventilation. They will have to be 21 years or more, to read, understand and sign an informed consent at their pre-operative evaluation. This study will be prospective, randomized, and blind to thoracic surgeons.", - "NCTID": "NCT02137291" - }, - { - "brief_title": "Effect of Direct Current Polarization on Brain Function", - "phase": "", - "drugs": "['0-15 Water']", - "drugs_list": [ - "0-15 Water" - ], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Participants will be right-handed volunteers, aged 20 to 70, without history of any disorder of the central nervous system. \n\n ", - "exclusion_criteria": ": \n\n Current serious medical or psychiatric condition of any kind. \n\n History of any significant trauma or medical condition affecting the brain or skull. \n\n History of epileptic seizure. \n\n Current use of neuroactive medications, medications affecting the cerebral circulation, or recreational drugs. \n\n Presence of metal in the head (other than dental hardware) or body, such as pacemakers, aneurysm clips, metallic prostheses (including heart valves or cochlear implants), patches with metallic foil backing, such as nicotine patches, permanent eyeliner or shrapnel fragments. \n\n History of welding or metal work. \n\n Broken skin in the area of the stimulating electrodes. \n\n Pregnancy/breastfeeding.", - "brief_summary": "This study will test a new electrical technique called direct current (DC) polarization that is able to change brain activity in subtle ways for a short time. A recent study showed that, depending on its direction, the current could make people perform a little better or perhaps slightly worse on a test of the function of the brain's frontal lobe. This study will use positron emission tomography (PET) scanning to examine how DC polarization affects brain activity.~Healthy volunteers between 20 and 70 years of age who are right handed and who are not taking any medications that affect the brain may be eligible for this study. Candidates are screened with a brief medical history and neurological evaluation.~Participants have a PET scan on three different days at least 3 days apart. Each scanning session takes 2-1/2 to 3 hours. For the scan, radioactive water is injected into the body through a vein. Subjects lie on a bed that slides in and out of the doughnut-shaped scanner, with their head held from the back by a padded holder and in front by a custom-molded plastic mask with holes for the eyes, nose, and mouth. DC electrodes made of wet sponges are placed on the right side of the head and over the left eye and are held in place with elastic bandages.~Three kinds of DC polarization are tested. In two tests the current is the same, but in opposite directions. The third is a sham (placebo) condition with no current delivered. Each of the three scans is separated by at least 3 days. On each day, a series of scans is done in a single session. Before each injection of tracer, the DC current is turned on. This may cause a tingling or slight burning on the skin under the electrodes, which disappears when the current is turned off. In each session, the subject receives 16 injections of tracer about 8 minutes apart, with DC polarization turned on for 4 out of the 8 minutes.~During most of the 8-minute periods, subjects are shown a pattern of dots about every 2 seconds. Sometimes the subject just looks at the patterns, and sometimes subjects are asked to push a button corresponding to the pattern they saw just before the current one. Sometimes they will be asked to push a button corresponding to the pattern that came before that one and so on, up to three patterns before the current one. The task lasts for about 2 minutes each time, with time to relax in between.", - "NCTID": "NCT00088569" - }, - { - "brief_title": "Effect of Brain Lesion Severity on Treatment Response in Late-Life Depression", - "phase": "", - "drugs": "['Sertraline']", - "drugs_list": [ - "Sertraline" - ], - "diseases": "['Depression']", - "diseases_list": [ - "Depression" - ], - "enrollment": "131.0", - "inclusion_criteria": "inclusion criteria: \n\n DSM-IV of major depressive disorder (MDD) \n\n Score of greater than 20 on the MADRS (score of greater than 17 for atypical depression) \n\n Score of greater than 20 on the Mini Mental State Examination (MMSE) \n\n ", - "exclusion_criteria": ": \n\n Any condition that may make having an MRI medically inadvisable \n\n Any severe or unstable medical conditions \n\n Any known primary neurological disorders, including history of stroke \n\n Any other simultaneous Axis I disorder \n\n History of substance or alcohol abuse disorder within 6 months prior to study entry \n\n Currently at risk for suicide \n\n History of failed prior adequate trials of two antidepressants for the current depressive episode \n\n History of failed prior adequate trial of sertraline \n\n Current use of any other psychoactive medications (medication washout will be required)", - "brief_summary": "This study will determine the relationship between brain lesion severity, treatment response, and frontal lobe brain function in people with late-life depression (LLD).", - "NCTID": "NCT00339066" - }, - { - "brief_title": "Prospective Study of Children and Adolescents With Craniopharyngioma", - "phase": "", - "drugs": "['Radiation', 'wait and watch']", - "drugs_list": [ - "Radiation", - "wait and watch" - ], - "diseases": "['Obesity', 'Craniopharyngioma']", - "diseases_list": [ - "Obesity", - "Craniopharyngioma" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosed with craniopharyngioma for the first time \n\n Age at diagnosis 18 years or less of age \n\n Agreement from patient's parents or legal guardian as well as the patient \n\n Criteria for inclusion in randomization study \n\n Histological diagnosis of craniopharyngioma \n\n Age at diagnosis 18 years or less of age \n\n Age at primary surgery over 5 years of age \n\n Incomplete primary resection \n\n Reference radiological confirmation of an incomplete resection \n\n Agreement from patient's parents or legal guardian as well as the patient \n\n ", - "exclusion_criteria": ": \n\n Age at diagnosis over 18 years of age No QoL measurement for randomization (3 months after surgery).", - "brief_summary": "The present investigation is a prospective, multicenter study evaluating craniopharyngioma patients' prognoses following the various currently-practiced therapeutic strategies.Primary goals of the study are to establish quality standards and compare the various therapy strategies with respect to their effectiveness and impact on the quality of life of treated patients. A stratified randomization of two treatment arms will be conducted with respect to timing of postoperative irradiation for the subgroup of patients \u22655 years of age whose tumors are incompletely resected. The researchers will investigate whether an immediate, postoperative irradiation is superior to progression-contingent irradiation based on alterations to quality of life (PEDQOL) from the time randomization is initiated (3rd month post op) to 3 years after randomization. Progression-free survival and overall survival will be examined as closely-related subgoals.Postoperative data will be evaluated via a surveillance study for all complete resection patients as well as for those patients under 5 years of age regardless of their resection grade.", - "NCTID": "NCT01272622" - }, - { - "brief_title": "Comparison of CXR and MnDCT", - "phase": "Phase 1", - "drugs": "['Minimum Dose CT']", - "drugs_list": [ - "Minimum Dose CT" - ], - "diseases": "['Acute Dyspnoea']", - "diseases_list": [ - "Acute Dyspnoea" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients admitted for investigation of acute pulmonary embolus \n\n ", - "exclusion_criteria": ": \n\n none", - "brief_summary": "A comparison of chest x-ray (CXR) and Minimum dose CT (MnDCT) in the acutely ill patient. The hypothesis is that MnDCT is more sensitive than CXR in the detection of acute findings in the acutely ill patient.", - "NCTID": "NCT00188435" - }, - { - "brief_title": "Evaluation of Mental Flexibility Through Language Tests in Adolescents With Frontal Brain Damage and in Healthy Children in Ages 8-17", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Persons With Frontal Lobe Damage With no Specific Language Disorder']", - "diseases_list": [ - "Persons With Frontal Lobe Damage With no Specific Language Disorder" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n frontal lobe damage \n\n at least one year after injury \n\n native hebrew speaker \n\n ", - "exclusion_criteria": ": \n\n specific language disorder \n\n premorbid learning disability", - "brief_summary": "This study aims to shed light on the theoretical concept of mental flexibility and its manifestation in adolescents following frontal lobe damage, and to develop a test battery for young Hebrew speakers.", - "NCTID": "NCT01696292" - }, - { - "brief_title": "Co-operative Behavior and Decision-making in Frontal Lobe Epilepsy", - "phase": "", - "drugs": "['functional magnetic resonance imaging exam']", - "drugs_list": [ - "functional magnetic resonance imaging exam" - ], - "diseases": "['Frontal Lobe Epilepsies']", - "diseases_list": [ - "Frontal Lobe Epilepsies" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria (Patients): \n\n Age between 18 and 50 \n\n Diagnosis of frontal lobe epilepsy \n\n Written consent to participate \n\n Right-handed \n\n Hospital Anxiety and Depression Scale Score under 10 \n\n Obsessive Compulsive Inventory Score under 40 \n\n Sufficient language skills \n\n Social insurance \n\n inclusion criteria (controls): \n\n Age between 18 and 50 \n\n Written consent to participate \n\n Right-handed \n\n Hospital Anxiety and Depression Scale Score under 10 \n\n Obsessive Compulsive Inventory Score under 40 \n\n Sufficient language skills \n\n Social insurance \n\n ", - "exclusion_criteria": " (Patients): \n\n Seizures types other than epileptic (psychogenic etc.) \n\n Mental retardation \n\n Epilepsies other than FLE \n\n Other known neurological diseases \n\n Hospital Anxiety and Depression Scale Score over 10 \n\n Obsessive Compulsive Inventory Score over 40 \n\n Pregnancy \n\n non-MRI suitable transplants (cardiac pacemaker etc.), claustrophobia, orthopedic diseases that prevent lying in the scanner \n\n During exclusion period of other studies \n\n No social insurance \n\n ", - "brief_summary": "Epilepsy is a frequent neurological disorder with about a third of patients having seizures despite treatment. At least some of these seizures can be linked to a low compliance and therapy adherence of patients. Compliance is defined as the extent to which a person's behavior (in terms of taking medication, following diets, or executing life style changes) coincides with medical or health advice. Therapy adherence of patients suffering from epilepsy is low with reported rates between 30 and 50%, although adherence to anticonvulsive drug therapy is critical for effective disease management and low therapy adherence is associated to higher mortality in epilepsy. The reasons for low therapy adherence are still a matter of research. Some known factors influencing compliance in epilepsy are related to its chronic nature, but others seem to lie in a complex interaction between psychiatric comorbidity and an impairment of neural systems underlying behavior. Furthermore, therapy adherence rests a variable difficult to measure, especially in epileptic patients where classical tools such as questionnaires and electronic monitoring devices have been shown to be imprecise. It has been argued that the term 'compliance' should be replaced by 'co-operative behavior' and non-compliance can therefore be interpreted as troubled co-operative behavior. This behavioral approach offers the potential of using tools and methods of the latest developments in behavioral neuroscience. Neuroeconomics, a scientific field on the border of psychology, economics and neuroscience, has used economic game paradigms in order to operationalize cooperative behavior and to identify several brain areas by functional brain imaging that have been linked to social co-operative behavior. The majority of these brain areas are located in the frontal cortex [ventromedial frontal/orbitofrontal cortex, and rostral anterior cingulate cortex. Epilepsies originating in the frontal lobe are subsumed under the term frontal lobe epilepsy (FLE) and represent 20-30% of all partial seizures and 25% of all refractory focal epilepsies referred to epilepsy surgery.~The investigator's project plans to study compliance and cooperative behavior of patients suffering from frontal lobe epilepsies through a neuroeconomic approach by (1) comparing the behavior of these patients in the prisoners' dilemma game to the behavior of age-, gender-, and education-matched healthy controls, (2) correlation of game behavior to brain activation measured by functional magnetic resonance imaging in both patients and healthy controls and (3) studying the link between cooperative behavior to compliance captured by pill counts and questionnaires.", - "NCTID": "NCT02441478" - }, - { - "brief_title": "A Randomized Controlled Trial of Lung Ultrasound Compared to Chest X-ray for Diagnosing Pneumonia in the Emergency Department", - "phase": "", - "drugs": "['Lung Ultrasound', 'Chest X-Ray']", - "drugs_list": [ - "Lung Ultrasound", - "Chest X-Ray" - ], - "diseases": "['Pneumonia']", - "diseases_list": [ - "Pneumonia" - ], - "enrollment": "191.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients who present to the ED with respiratory symptoms suspicious for pneumonia \n\n In whom the treating physician believes would benefit from diagnostic imaging \n\n ", - "exclusion_criteria": ": \n\n Patients who arrive at the ED with a previously performed CXR \n\n Unstable patients with life-threatening injuries who require ongoing resuscitation", - "brief_summary": "The primary objective of this study is to determine if lung ultrasound (LUS) can replace chest x-ray (CXR) when evaluating patients with possible pneumonia. Specifically, we are looking for an overall reduction of CXR when LUS is used first. Our null hypothesis is that LUS cannot replace CXR for diagnosing pneumonia. Our alternate hypothesis is that LUS can replace CXR for diagnosing pneumonia. Our secondary objectives include: (1) a comparison of unscheduled healthcare visits after the index Emergency Department (ED) visit between those subjects who undergo CXR first and those who undergo LUS first, (2) an evaluation of the rate of antibiotic use between the two groups, (3) a comparison of the admission rates, and (4) a comparison of the length of stay in the Emergency Department between the two groups.", - "NCTID": "NCT01654887" - }, - { - "brief_title": "Measurement of Extravascular Lung Water to Detect and Predict Primary Graft Dysfunction Following Lung Transplant", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Primary Graft Dysfunction']", - "diseases_list": [ - "Primary Graft Dysfunction" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n All consecutive bilateral lung transplant recipients \n\n ", - "exclusion_criteria": ": \n\n Immediate need for extracorporeal life support following transplant (those requiring ECLS four hours after intensive care admission can be included as the investigators would have obtained some ELWI measurements) \n\n Contraindications to femoral artery catheterization (eg, abdominal aortic aneurysm)", - "brief_summary": "Primary graft dysfunction (PGD) is the most common cause of early morbidity and mortality following lung transplant and is characterized by acute lung injury and capillary leak leading to an increase in extravascular lung water index (ELWI) and impaired graft function. PGD has many features in common with acute respiratory distress syndrome (ARDS). PGD may be life-threatening and can also lead to impaired long term lung function. In ARDS, a restrictive fluid strategy has been associated with an improvement in lung function and outcomes. Accurate methods of evaluating, quantifying and guiding the hemodynamic / fluid management and limiting the extent of ELWI that accumulates in the setting of PGD are lacking. Using transpulmonary thermodilution to estimate ELWI and the pulmonary permeability index (PPI) represents a novel approach to fluid management, which has been used in patients with ARDS, but to date not in the transplant setting. To determine if these measurements may better guide the management of lung transplant patients, the investigators first wish to establish whether these methods are able to predict the onset of clinical pulmonary edema earlier, whether they correlated with traditional markers of PGD, and whether they may be useful for predicting outcomes.~AIM 1: The investigators will evaluate the correlation between ELWI and current surrogates of pulmonary edema in lung transplant patients with and without Primary Graft Dysfunction (PGD)~AIM 2: The investigators will correlate the use of ELWI and PPI to determine the presence and severity of PGD.~AIM 3: a) The investigators will determine whether early measurements of ELWI and PPI can predict the onset of PGD.~b) Across different strata of PGD, the investigators will determine whether ELWI and PPI have a differential effect on duration of mechanical ventilation.~The results of the study will be used for the following:~Provide the rationale for routine monitoring of ELWI to detect PGD if found to be more discriminatory and have a stronger association with outcome compared to the current gold standard.~Provide the means of early identification of those as risk of developing PGD in order to guide management decisions or future therapeutic interventions aimed at preventing or treating PGD.~Provide the requisite groundwork for a clinical trial comparing the effects of an ELWI-driven protocol versus usual care on ICU outcomes in lung transplant recipients.", - "NCTID": "NCT01605214" - }, - { - "brief_title": "Prostate Cancer Genomic Heterogeneity", - "phase": "Phase 1; Phase 2", - "drugs": "['Targeted biopsies of the prostate']", - "drugs_list": [ - "Targeted biopsies of the prostate" - ], - "diseases": "['PROSTATE CANCER']", - "diseases_list": [ - "PROSTATE CANCER" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Treatment na\u00efve group \n\n Men with no prior diagnosis of prostate cancer undergoing prostate biopsy based on identified lesions on imaging \n\n Men with a raised PSA above 15ng/ml \n\n Men giving informed consent \n\n Treated men \n\n Men undergoing tissue biopsy for suspicion of prostate cancer recurrence following previous local or systemic therapy based on identified lesions in multi-parametric MRI, bone-scan, choline PET/CT, or PET/MRI \n\n ", - "exclusion_criteria": ": \n\n 1. Unable to have MRI scan or CT scan, or in whom artefact would reduce scan quality \n\n Unable to have prostate biopsy \n\n Unable to undergo biopsy for metastatic evaluation \n\n On immunosuppression or predefined immunosuppressed state \n\n A coagulopathy predisposing to bleeding \n\n Unable to give informed consent", - "brief_summary": "The purpose of this study is to carry out very detailed genetic testing on prostate cancer cells. The reason to do this is because researchers do not fully understand~How prostate cancer develops~Why some cancer cells spread and others do not~Why some cancer cells respond to treatment and others do not~Researchers and doctors know that 1 in 3 of the male population over the age of 50 has cancer cells in their prostate. However, most of these men will never know they have it and it will not affect their quality of life or their life expectancy. However, some cancers can be aggressive. These are more likely to spread outside of the prostate and cause problems. Doctors do not have an accurate way to tell the difference between aggressive cancer and those which will not cause any problems. Even within one prostate some tumours are aggressive and others do not cause a problem during the lifetime of a patient. In fact, even within one tumour, different cells may behave differently. In other words, one part of the tumour may be aggressive and spread, whilst another part of the same tumour does not. This project will try to find out more about what makes different tumours and different parts of the same tumour aggressive or harmless.~It is important to find out what makes some cancer cells spread and others stay where they are. For the investigators to do this they need to collect fresh samples of cancer tissue from the prostate and from different areas of a tumour within the prostate. This is because biopsies used to diagnose or exclude cancer by the hospital laboratory are not good enough to give investigators detailed genetic information. These biopsies have been put into a chemical called formalin which reduces the quality of the genetic information.~Investigators are therefore asking patients who are undergoing prostate biopsies as part of their normal care to allow them to take additional biopsies for the purpose of this study. This may be the first time patients are having biopsies. Or, patients may be having biopsies after treatment that has been given for the cancer and the doctors are concerned the treatment is not working.", - "NCTID": "NCT02022371" - }, - { - "brief_title": "Cediranib (AZD2171, RECENTIN\u2122) in Metastatic or Recurrent Renal Cell Carcinoma", - "phase": "Phase 2", - "drugs": "['Cediranib', 'Cediranib Placebo']", - "drugs_list": [ - "Cediranib", - "Cediranib Placebo" - ], - "diseases": "['Renal Cell Carcinoma']", - "diseases_list": [ - "Renal Cell Carcinoma" - ], - "enrollment": "105.0", - "inclusion_criteria": "inclusion criteria: \n\n Confirmation of metastatic or recurrent renal cell carcinoma \n\n ", - "exclusion_criteria": ": \n\n Certain types of previous anti-cancer therapy for Renal Cell Carcinoma \n\n Patients with type I insulin-dependent diabetes or poorly-controlled type II insulin-independent diabetes \n\n Patients with a history of poorly controlled high blood pressure", - "brief_summary": "Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours and also how well it is tolerated.", - "NCTID": "NCT00423332" - }, - { - "brief_title": "The Incidence of Nontuberculous Mycobacterial Pulmonary Infection in Bilateral Bronchiectasis and Bronchiolitis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Bronchiectasis', 'Bronchiolitis']", - "diseases_list": [ - "Bronchiectasis", - "Bronchiolitis" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients with bronchiectasis or bronchiolitis \n\n ", - "exclusion_criteria": ": \n\n All patients with severe lung disease other than bronchiectasis \n\n Active lung infection \n\n Active infection other site except the lung", - "brief_summary": "Nontuberculous mycobacteria (NTM) are ubiquitous organisms in the environment and are now increasingly being recognized as significant causes of chronic pulmonary infection in immunocompetent individuals (1). The most frequently encountered NTM lung disease worldwide is caused by Mycobacterium avium-intracellular complex (MAC) (2-4).~In several studies with chest computed tomography (CT), researchers have demonstrated that the presence of bilateral multifocal bronchiolitis (well-defined small nodules and branching centrilobular nodules, or tree-in-bud pattern) and bronchiectasis distributed mainly in the right middle lobe and lingular segment are indicative of NTM pulmonary infection (7-11). Accordingly, it is believed that radiologic findings of bilateral bronchiolitis and bronchiectasis on chest CT scans specifically suggest NTM pulmonary infection (1). These CT findings, however, may not be specific for NTM pulmonary infection. CT patterns of bronchiectasis and bronchiolitis in the pulmonary infections caused by various NTM organisms have been reported, and these organisms include Mycobacterium kansasii, Mycobacterium xenopi, and rapidly growing mycobacteria such as Mycobacterium abscessus, Mycobacterium fortuitum, and Mycobacterium chelonae (12-14). In addition, not all patients with bronchiectasis and bronchiolitis have NTM pulmonary infection. Two recent studies showed that only about 50% of patients with such CT features have MAC pulmonary infection (9,15). To the best of our knowledge, however, there is no report about the incidence of NTM in patients with bronchiectasis or bronchiolitis in countries with low incidence of TB. Thus, the purpose of our study was to determine the frequency of NTM pulmonary infection in patients with bilateral bronchiectasis and bronchiolitis at chest CT and to investigate whether these CT findings are specifically indicative of MAC infection or other specific pathogen.", - "NCTID": "NCT01354912" - }, - { - "brief_title": "Vibration Response Imaging (VRI) in Children With Acute Respiratory Symptoms", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pneumonia']", - "diseases_list": [ - "Pneumonia" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject's parent or legal guardian, is able and willing to read the Informed Consent, understands the Informed Consent, and provides written Informed Consent for the subject; if the minor child is in fact able to give consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian. \n\n Boy or girl in the age range of 3-18 years. \n\n Patient presented with acute respiratory complaints, acute cough, onset of shortness of breath, or fever. \n\n Patient referred by ED physician and presented for CXR. \n\n ", - "exclusion_criteria": ": \n\n Body habitus or skin condition that might prevent the placement of the sound sensors on the back (e.g. severe scoliosis, kyphosis, chest wall deformation, skin lesion on the back or compression fracture); \n\n Potentially contagious skin lesion on the back; \n\n Subject has had lung surgery; \n\n Subject was prescribed the CXR for monitoring or follow up of a lung condition that pre-existed the current, acute symptoms.", - "brief_summary": "The VRI device may provide a complementary diagnostic tool for lung examination and aid the physician in determining whether a chest x-ray should be performed.", - "NCTID": "NCT00992966" - }, - { - "brief_title": "Biomarker Differences in Samples From Patients With Undifferentiated Sarcomas", - "phase": "", - "drugs": "['laboratory biomarker analysis']", - "drugs_list": [ - "laboratory biomarker analysis" - ], - "diseases": "['Soft Tissue Sarcoma']", - "diseases_list": [ - "Soft Tissue Sarcoma" - ], - "enrollment": "49.0", - "inclusion_criteria": "inclusion criteria: \n\n 49 cases of undifferentiated sarcomas from ARST0332 (additional cases may be ascertained as eligible for this current project that also fall under ARST0332 to be requested later if necessary)", - "exclusion_criteria": "", - "brief_summary": "This clinical trial studies biomarker differences in samples from patients with undifferentiated sarcomas. Studying biomarker in tissue samples from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer", - "NCTID": "NCT01802125" - }, - { - "brief_title": "Transcranial Magnetic Stimulation and Anti-epileptic Effect: Optimization and Evaluation With Electrophysiology.", - "phase": "", - "drugs": "['cortical magnetic stimulation provided by an eight-shaped co\u00efl placed upon the skull.']", - "drugs_list": [ - "cortical magnetic stimulation provided by an eight-shaped co\u00efl placed upon the skull." - ], - "diseases": "['Refractory Frontal Lobe Epilepsy']", - "diseases_list": [ - "Refractory Frontal Lobe Epilepsy" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria: \n\n Cryptogenic frontal lobe epilepsy \n\n Normal cerebral MRI", - "exclusion_criteria": "", - "brief_summary": "Epileptic disease is characterised by enhanced brain excitability. Low frequency repetitive transcranial magnetic stimulation (rTMS) can be an effective treatment for refractory frontal epilepsy. Thought, physiological mechanisms of its effectivity are still unknown. It is yet possible to evaluate cortical excitability and inhibition with TMS-coupled electromyography before and after rTMS sessions ; this could provide clues for basic mechanisms of rTMS effects on the epileptic brain. We assume that rTMS decrease brain excitability by improving brain inhibition. Such an information could help for treating patients with both pharmacological and non-pharmacological methods.", - "NCTID": "NCT00382707" - }, - { - "brief_title": "Elective vs Therapeutic Neck Dissection in Treatment of Early Node Negative Squamous Carcinoma of Oral Cavity", - "phase": "", - "drugs": "['Elective neck dissection in early oral cancer', 'Therapeutic Neck Dissection']", - "drugs_list": [ - "Elective neck dissection in early oral cancer", - "Therapeutic Neck Dissection" - ], - "diseases": "['Oral Cancer']", - "diseases_list": [ - "Oral Cancer" - ], - "enrollment": "710.0", - "inclusion_criteria": "inclusion criteria: \n\n Histologically proven T1 or T2 N0 M0 (clinical) squamous cell carcinoma of the buccal mucosa, lower alveolus, oral tongue and floor of mouth. \n\n Surgery is the preferred treatment and the primary tumor can be excised with clear margins via the per-oral route. \n\n No history of a prior malignancy in the head and neck region. \n\n No prior malignancy outside the head and neck region in the preceding 5 years. \n\n Patient will be reliable for follow-up \n\n Age> 18 years and < 75 years. \n\n No significant co-morbid conditions - ASA grade II and I. \n\n Understands the protocol and is able to give informed consent. \n\n ", - "exclusion_criteria": ": \n\n Prior radiotherapy or surgery for malignancy in the head and neck region. \n\n Non squamous cell carcinomas of the oral cavity. \n\n Upper alveolus and palatal lesions where there is a possibility of retropharyngeal node involvement. \n\n Per-oral excision of tumor will compromise margins in the opinion of the treating surgeon. \n\n Significant co-existing pre-malignant conditions like erytho-leucoplakia and oral sub mucous fibrosis that in the opinion of the clinician would interfere in the planned treatment management of the patient.", - "brief_summary": "Cervical nodal metastasis is the single most important prognostic factor in head and neck cancers. Appropriate management of the neck is therefore of paramount importance in the treatment of these cancers. While it is obvious that the positive neck must be treated, controversy has always surrounded the clinically node negative neck with respect to the ideal treatment policy.The situation is difficult with regards to early cancers of the oral cavity (T1/T2). These cancers are usually treated with surgery where excision is through the per-oral route. Elective neck dissection in such a situation is an additional surgical procedure with its associated costs, prolonged hospitalization and may be unnecessary in as high as 80% of patients who finally turn out to be pathologically node negative. Should the neck be electively treated or there be a wait and watch policy? Current practice is that the neck is always addressed whenever there is an increased propensity to cervical metastasis or when patient follow-up is unreliable.~There is clearly a need therefore for a large randomized trial that will resolve the issue either way once and for all.~Primary Objective:~To demonstrate whether elective neck dissection (END) is equal or superior to the wait and watch policy i.e.~therapeutic neck dissection (TND) in the management of the clinically No neck in early T1 /T2 cancers of the oral cavity.~Secondary Objective:~Does Ultrasound examination have any role in the routine initial workup of a node negative patient?~How are patients ideally followed up -does sonography have a role or is clinical examination sufficient.~Is assessment of tumor thickness by the surgeon at the time of initial surgery accurate -Is there a correlation~Identify histological prognostic factors in the primary that may help identify a sub-set of patients at an increased risk for cervical metastasis.", - "NCTID": "NCT00193765" - } - ], - "1": [ - { - "brief_title": "The Watch the Spot Trial", - "phase": "", - "drugs": "['More Frequent Surveillance Strategy', 'Less Frequent Surveillance Strategy']", - "drugs_list": [ - "More Frequent Surveillance Strategy", - "Less Frequent Surveillance Strategy" - ], - "diseases": "['Solitary Pulmonary Nodule', 'Coin Lesion, Pulmonary', 'Lung Neoplasms', 'Carcinoma, Non-small-cell Lung']", - "diseases_list": [ - "Solitary Pulmonary Nodule", - "Coin Lesion", - "Pulmonary", - "Lung Neoplasms", - "Carcinoma", - "Non-small-cell Lung" - ], - "enrollment": "35200.0", - "inclusion_criteria": "inclusion criteria: \n\n The target population includes adults with small lung nodules that may represent a new diagnosis of lung cancer, who typically would be managed by CT surveillance in usual clinical practice. Thus, we will enroll all patients: \n\n aged \u226535 years \n\n at least one nodule measuring \u226415 mm in average diameter on chest CT. \n\n ", - "exclusion_criteria": ": \n\n Pregnant Women \n\n Age <35 years \n\n Known diagnosis of cancer (except non-melanoma skin cancer) within 5 years", - "brief_summary": "This study will compare two clinically accepted protocols for surveillance imaging in individuals who are found to have a small pulmonary nodule on chest computed tomography (CT) scans.", - "NCTID": "NCT02623712" - }, - { - "brief_title": "Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery", - "phase": "", - "drugs": "['cryosurgery', 'positron emission tomography']", - "drugs_list": [ - "cryosurgery", - "positron emission tomography" - ], - "diseases": "['Lung Cancer', 'Metastatic Cancer']", - "diseases_list": [ - "Lung Cancer", - "Metastatic Cancer" - ], - "enrollment": "40.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Histologically or cytologically confirmed malignant pulmonary neoplasm \n\n New lung lesion(s) with definitive clinical and imaging features of primary or metastatic disease allowed \n\n Imaging findings compatible with localized treatment failure after prior cryotherapy allowed \n\n Malignant pleural effusion allowed provided it is associated with a distinct measurable pulmonary mass amenable to cryotherapy \n\n Metastatic disease must meet all of the following criteria: \n\n Primary tumors have been resected or have been deemed controlled by other therapies \n\n No other widespread metastases evident (e.g., multiple hepatic or brain metastases) \n\n Each pulmonary mass must be amenable to CT-guided percutaneous cryotherapy approach \n\n No more than 5 targeted masses for study therapy \n\n Target mass defined as pulmonary, hilar, mediastinal, and/or chest wall mass > 1 cm, but < 10 cm in average diameter \n\n Unresectable disease by surgical consultation OR patient refused surgical options \n\n Nonenhanced and enhanced CT scan required within the past 6 weeks done at 4-5 mm increments with available soft tissue and mediastinal windows to assess size and extent of all thoracic tumors \n\n PET scan required within the past 6 months noting the correlation with the above CT locations, if not already obtained by a combined PET/CT scanner \n\n PATIENT CHARACTERISTICS: \n\n Karnofsky performance status (PS) > 60-100% OR WHO/ECOG/Zubrod PS 0-2 \n\n FEV_1 > 30% of predicted \n\n DLCO > 40% of predicted \n\n Platelet count \u2265 70,000/mm^3 \n\n INR < 1.5 \n\n No uncontrolled coagulopathy or bleeding diathesis \n\n Not pregnant or nursing \n\n Negative pregnancy test \n\n No serious medical illness, including any of the following: \n\n Uncontrolled congestive heart failure \n\n Uncontrolled angina \n\n Myocardial infarction \n\n Cerebrovascular event within 6 months prior to study entry \n\n No medical contraindication or potential problem that would preclude study compliance \n\n PRIOR CONCURRENT THERAPY: \n\n At least 7 days since prior aspirin and aspirin-like medications \n\n At least 3 days since prior warfarin, clopidogrel bisulfate, or similar compounds \n\n No concurrent drugs causing bleeding tendencies (e.g., aspirin, warfarin, or clopidogrel bisulfate) \n\n No concurrent participation in other experimental studies", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Cryotherapy kills tumor cells by freezing them. This may be an effective treatment for primary lung cancer or lung metastases that cannot be removed by surgery.~PURPOSE: This clinical trial is studying how well cryotherapy works in treating patients with primary lung cancer or lung metastases that cannot be removed by surgery.", - "NCTID": "NCT00303901" - }, - { - "brief_title": "Biomarkers for Diagnosis of Lung Nodules", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Lung Abscess']", - "diseases_list": [ - "Lung Abscess" - ], - "enrollment": "468.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult 18-85 years of age \n\n Patients referred to pulmonologists, oncologists, or thoracic surgeons for the evaluation of peripheral lung nodules found on CT scan. \n\n Repeat CT scans, biopsy or surgical excision are clinically indicated to determine the etiology of the nodule. \n\n One or more lung nodules must be between 8 mm and 30 mm in the greatest diameter. \n\n Patients must be fully informed of the investigational nature of the procedure and sign an informed consent. \n\n - \n\n ", - "exclusion_criteria": ": \n\n Lung nodules or masses greater than 30 mm in the greatest dimension. \n\n Lung nodules that have solid calcification. \n\n Lung nodules or masses with CT evidence of partial or complete obstruction of a lobar bronchus, main stem bronchus or the trachea. \n\n No prior cancer with the exception of non-melanoma skin cancer. \n\n Life expectancy of < 6 months \n\n Any individual who does not give oral and written consent for participation -", - "brief_summary": "A need exists for non-invasive testing to aid in clinical decision-making for Computerized Tomography (CT) scan detected lung nodules of indeterminate etiology. The investigators hypothesize that biomarkers detectable in blood, sputum or urine may be useful for guiding clinical decisions in the setting of CT detected lung nodules to determine which nodules are malignant and which are benign. The investigators also hypothesize that these biomarkers will decrease in concentration to the normal range after successful surgical treatment of malignant lung nodules.", - "NCTID": "NCT01085864" - }, - { - "brief_title": "Assess the Variability of Uni-Dimensional, Bi-Dimensional, and Volumetric CT Scan Measurement of Non-Small Cell Lung Cancer Tumors", - "phase": "", - "drugs": "['CT Scan']", - "drugs_list": [ - "CT Scan" - ], - "diseases": "['Lung Cancer', 'Non Small Cell']", - "diseases_list": [ - "Lung Cancer", - "Non Small Cell" - ], - "enrollment": "37.0", - "inclusion_criteria": "inclusion criteria: \n\n Have pathologically confirmed non-small cell lung cancer \n\n Have measurable primary pulmonary tumors \u2265 1cm \n\n Have plans for a clinically indicated non-contrast CT scan of the chest \n\n All patients must be \u2265 18 years old \n\n ", - "exclusion_criteria": ": \n\n Pregnant or lactating women", - "brief_summary": "The purpose of this study is to compare the results of two CT scans of the chest performed within minutes of each other. We will compare several different measurements of lung cancer tumors. This study will help show whether we can get accurate results when we compare measurements on different CT scans. This information is important for patients with cancer, who often have more than one CT scan during their treatment.", - "NCTID": "NCT00579852" - }, - { - "brief_title": "Docetaxel Plus Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer", - "phase": "Phase 2", - "drugs": "['carboplatin', 'docetaxel']", - "drugs_list": [ - "carboplatin", - "docetaxel" - ], - "diseases": "['Lung Cancer']", - "diseases_list": [ - "Lung Cancer" - ], - "enrollment": "38.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: Histologically confirmed stage IIIB with metastatic pleural effusion or metastatic stage IV non-small cell lung cancer Large cell Adenocarcinoma Squamous cell Bronchioalveolar carcinoma Undifferentiated No small cell or carcinoid histologies At least 1 bidimensionally measurable or evaluable indicator lesion Measurable or evaluable indicator lesion(s) must be completely outside the radiation portal or there must be proof of disease progression No current CNS metastases at study entry No meningeal carcinomatosis \n\n PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT and/or SGPT no greater than 2.5 times ULN if alkaline phosphatase less than ULN, OR alkaline phosphatase no greater than 4 times ULN if SGOT and/or SGPT less than ULN Renal: Creatinine clearance at least 50 mL/min Other: No concurrent illness that would effect assessment of this study Not pregnant or nursing Effective contraception required of all fertile patients \n\n PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior radiotherapy for non-small cell lung cancer allowed Radiotherapy for new brain metastases (other than leptomeningeal disease) is allowed during study, but chemotherapy is stopped during and for 2 weeks following radiotherapy Concurrent radiotherapy to other sites allowed if there is no objective criteria for disease progression Surgery: Not specified Other: No other concurrent experimental drug", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in treating patients who have stage IIIB or stage IV non-small cell lung cancer.", - "NCTID": "NCT00003562" - }, - { - "brief_title": "Differentiation of Malig. & Ben. Solitary Pulm. Nodules & Prediction of Clin. Outcome Using Perfus. Analysis of DCEMRI", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Lung Neoplasms']", - "diseases_list": [ - "Lung Neoplasms" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n patients who have solitary pulmonary nodules in CT \n\n ", - "exclusion_criteria": ": \n\n patients who don't fit the above inclusion criteria", - "brief_summary": "The purpose of our study is to determine whether contrast-enhanced dynamic MRI (DCE MRI) analysis of tumor angiogenesis and perfusion can be used as a reliable modality to differentiate benign from malignant solitary pulmonary nodules (SPN) before surgical intervention, using kinetic model derived from DCE MRI, and further correlate if there is any positive correlation between angiogenesis factor (vascular endothelial growth factor VEGF, microvessel density MVD); and if the perfusion parameters from DCE MRI can predict patients' outcomes and survival.", - "NCTID": "NCT00172575" - }, - { - "brief_title": "ThoHSpEkt Thoracoscopic Ectomy of Radioactively Marked Pulmonary Nodules With Free-hand SPECT", - "phase": "Phase 2", - "drugs": "['Radioactive labelling of pulmonary nodules', 'CT guided radioactive labelling', 'Electromagnetic guided bronchoscopic radioactive labelling']", - "drugs_list": [ - "Radioactive labelling of pulmonary nodules", - "CT guided radioactive labelling", - "Electromagnetic guided bronchoscopic radioactive labelling" - ], - "diseases": "['Solitary Pulmonary Nodule', 'Bronchial Neoplasms']", - "diseases_list": [ - "Solitary Pulmonary Nodule", - "Bronchial Neoplasms" - ], - "enrollment": "11.0", - "inclusion_criteria": "inclusion criteria: \n\n age over 18 years \n\n Planed thoracoscopic surgery of a pulmonary nodule \n\n Informed consent \n\n ", - "exclusion_criteria": ": \n\n mental incapacity \n\n contraindications for this treatment \n\n pregnancy", - "brief_summary": "Title ThoHSpEkt~Study Design Pilot Study concerning the technical operative methods and a phase II study concerning the radiopharmaceutical (therapeutic-explorative study with an approved drug in a new indication)~Location Kantonsspital St.Gallen~Aim Proof of feasibility of thoracoscopic ectomy of radioactively marked pulmonary nodules with the help of free-hand SPECT.~Background In the Cantonal Hospital of St.Gallen an average of 30 - 40 patients will be operated with thoracoscopic ectomy for a pulmonary nodule. When localisation of the nodule is not possible a switch to minithoracotomy is performed.~Study intervention Marking of pulmonary nodules with radioactivity. Free-hand SPECT guided surgery~Risks Risks of bronchoscopic or CT-intervention Radiation risk (minimal)~Rational for patient number 10 patients for each group are enough to prove the feasibility, to manage difficulties and to record complications~Duration approximately 24 months.", - "NCTID": "NCT02050724" - }, - { - "brief_title": "Percutaneous Image Guided Video-Assisted Thoracic Surgery (VATS) Resection of Lung Lesions", - "phase": "Phase 2", - "drugs": "['Video-Assisted Thoracic Surgery (VATS) wedge resection']", - "drugs_list": [ - "Video-Assisted Thoracic Surgery (VATS) wedge resection" - ], - "diseases": "['Lung Cancer']", - "diseases_list": [ - "Lung Cancer" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n peripheral lung nodules < 3cm in size \n\n Surgical candidate \n\n ", - "exclusion_criteria": ": \n\n Non surgical candidate", - "brief_summary": "This is a phase II protocol to determine the safety and feasibility of Intraoperative CT fluoroscopy guidance for lung resection for small nodules.", - "NCTID": "NCT01847209" - }, - { - "brief_title": "Early Detection of Lung Tumors by Sniffer Dogs - Evaluation of Sensitivity and Specificity", - "phase": "Phase 1", - "drugs": "['exhalation analysis of breath sample', 'exhalation analysis of breath sample', 'exhalation analysis of breath sample']", - "drugs_list": [ - "exhalation analysis of breath sample", - "exhalation analysis of breath sample", - "exhalation analysis of breath sample" - ], - "diseases": "['Lung Cancer', 'Chronic Obstructive Airway Disease']", - "diseases_list": [ - "Lung Cancer", - "Chronic Obstructive Airway Disease" - ], - "enrollment": "230.0", - "inclusion_criteria": "inclusion criteria: \n\n age 18-80 \n\n competent \n\n confirmed lung cancer \n\n ", - "exclusion_criteria": ": \n\n history of other cancers", - "brief_summary": "Some groups reported that sniffer dogs can be applied to detect lung cancer in the exhaled breath of patients. Therefore, breath samples (BS) of patients are collected. Five sniffer dogs are trained to distinguish between the BS of patients with lung cancer and healthy individuals (controls). In a prospective, randomized blinded study the dog's ability to differentiate between BS of i) patients with lung cancer, ii) patients with inflammatory airway disease, but no evidence of cancer and iii) healthy individuals is tested.", - "NCTID": "NCT01141842" - }, - { - "brief_title": "A Multi-Center Trial of the ProLung Test\u2122", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Solitary Pulmonary Nodule', 'Multiple Pulmonary Nodules']", - "diseases_list": [ - "Solitary Pulmonary Nodule", - "Multiple Pulmonary Nodules" - ], - "enrollment": "420.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects who meet all of the following criteria may be enrolled in this Study: \n\n Subject is male or female, age 18 or older. \n\n Subject has undergone CT scan of the lung(s) that indicates one or more nodules or lesions suspicious for lung cancer. \n\n Subject's pulmonary nodule or lesion is greater than 4mm. Size is determined by the largest nodule or lesion dimension identified from CT imaging. \n\n Subject meets one or more of the following conditions: \n\n indicated for a tissue biopsy \n\n indicated for surgical resection of the lung \n\n Subject must be able to receive a ProLung Test \n\n within 60 days of abnormal CT (Inclusion Criterion 2 & 3) \n\n within 60 days prior to the tissue biopsy or surgical resection (Inclusion Criterion 4). \n\n Subject is capable of understanding and agreeing to fulfill the requirements of this Protocol. \n\n Subject has signed the IRB/IEC approved Informed Consent Form (ICF). \n\n ", - "exclusion_criteria": " \n\n The following criteria will disqualify a subject from enrollment into this Study: \n\n Subject has an implanted electronic device in the chest. \n\n Subject receiving therapy for suspected chest infection such as fungal infection or tuberculosis. \n\n Subject with diagnosed malignancy other than lung cancer, non-melanoma skin cancer or any cancer in which the Principal Investigator does not suspect metastatic disease to the lung, who has 2 or more suspicious pulmonary nodules. \n\n Subject has received an invasive medical or surgical procedure within the thoracic cavity within 30 days prior to the ProLung Test or within the previous 14 days for a bronchoscopic procedure. \n\n Subject presents with an anomalous physical or anatomical condition that precludes ProLung Test measurement. \n\n Subject will have undergone unusually strenuous exercise within 24 hours. \n\n Subject who has significant systemic diseases such as uncontrolled diabetes, advanced heart failure, or a recent myocardial infarction, or other medical condition such as severe morbid obesity that in the judgment of the Principal Investigator would make him/her unsuitable for the Study.", - "brief_summary": "The primary Study hypothesis is that the ProLung Test will demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer. A statistically significant result will indicate that patients with a high ProLung Test result have a greater risk of developing lung cancer than patients with a low test result.~There are three Specific Aims of this study:~Optimize and confirm the stability of the ProLung Test risk-stratification algorithm in patients with a diagnosis.~Externally validate the efficacy of the ProLung Test risk-stratification algorithm by comparing the test result to the conclusive patient diagnosis.~Assess the safety and tolerability of the ProLung Test procedures.~Study Design This Study consists of two distinct phases, Stabilization and Validation. The Study will collect data from multiple sites (3 to 12), and each site may enroll patients and collect data for the Stabilization and Validation Phases with a minimum of three sites for the Validation Phase.", - "NCTID": "NCT01566682" - }, - { - "brief_title": "EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules", - "phase": "", - "drugs": "['Cryo biopsy']", - "drugs_list": [ - "Cryo biopsy" - ], - "diseases": "['Yield of Cryo Biopsy in Lung Cancer', 'Solitary Pulmonary Nodule']", - "diseases_list": [ - "Yield of Cryo Biopsy in Lung Cancer", - "Solitary Pulmonary Nodule" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n solitary pulmonary nodule < 4 cm \n\n no endobronchial lesion \n\n indication for bronchoscopy \n\n ", - "exclusion_criteria": ": \n\n coagulopathy \n\n pulmonary hypertension \n\n pregnancy", - "brief_summary": "To proof the feasibility and safety of EBUS guided transbronchial cryo biopsies in peripheral lung lesions", - "NCTID": "NCT01221493" - }, - { - "brief_title": "Thoracoscopic Localization of Pulmonary Nodules Using Direct Intracavitary Thoracoscopic Ultrasound", - "phase": "", - "drugs": "['intracavitary ultrasound']", - "drugs_list": [ - "intracavitary ultrasound" - ], - "diseases": "['Lung Cancer']", - "diseases_list": [ - "Lung Cancer" - ], - "enrollment": "93.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients with CT identified pulmonary nodules not deemed to be visualizable during VATS who are candidates for VATS resection. \n\n ", - "exclusion_criteria": ": \n\n Inability to consent for the study. \n\n Patients less than 18 years old. \n\n Patients with pulmonary nodules easily located during VATS. \n\n Patients with tumours extending to visceral pleura or chest wall. \n\n Patients who have chest anatomy precluding VATS resection.", - "brief_summary": "Pulmonary nodules are one of the most common thoracic radiographic abnormalities. They are usually found accidentally as discrete well emarginated pulmonary lesions found within the lung parenchyma during a routine chest x-ray. Pulmonary nodules are usually asymptomatic. Most solitary lung nodules are benign; however these nodules can represent early stage lung cancer. The identification of malignant pulmonary nodules is important because they represent a potential form of curable lung malignancy. Every lung nodule should therefore be investigated for the possibility of malignancy.~Ultrasound has been beneficial in almost all medical and surgical specialities. The idea of using ultrasound during VATS has emerged from its use in laparoscopic procedures. Few studies have investigated the use intracavitary ultrasound for localizing pulmonary nodules. The sensitivity of ultrasound detecting pulmonary nodules is high (92%). In some studies, ultrasound could detect all pulmonary nodules detected by high resolution CT. It has also been shown to be able to locate nodules not visualized on spiral CT.~The use of intracavitary ultrasound has been suggested by many authors as a safe and effective method for localizing hard to find nodules. It is a real time technique with no associated complications, low cost, and has the potential to save operative time. Most importantly, it may be able to prevent conversion of VATS to open operations in cases where nodules are not visualizable or locatable using VATS techniques.~The use of intracavitary US as a localization method by surgeons intra-operatively could lead to better identification of nodules. Also, this technique could avoid performing multiple procedures on patients (CT guided targeting followed by surgery) and therefore is more cost-efficient. If proven accurate, surgeon-performed intracavitary ultrasound could be used routinely during VATS procedures, increasing the chances of finding and localizing pulmonary nodules using minimally invasive techniques.", - "NCTID": "NCT01201824" - }, - { - "brief_title": "Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Docetaxel in Platinum-Resistant Non-Small Cell Lung Cancer", - "phase": "Phase 1; Phase 2", - "drugs": "['TLK286 in combination with docetaxel']", - "drugs_list": [ - "TLK286 in combination with docetaxel" - ], - "diseases": "['Carcinoma, Non-small-cell Lung']", - "diseases_list": [ - "Carcinoma", - "Non-small-cell Lung" - ], - "enrollment": "28.0", - "inclusion_criteria": "inclusion criteria include: \n\n Histologically confirmed non-small cell bronchogenic carcinoma, including squamous cell carcinoma, undifferentiated carcinoma, adenocarcinoma, mixed (adenocarcinoma with squamous cell carcinoma), bronchoalveolar carcinoma, or large cell carcinoma \n\n Stage IV or Stage IIIB \n\n Progressed during or after first-line therapies with platinum-containing regimens in the advanced or metastatic treatment regimen \n\n At least 18 years of age \n\n Good performance status (ECOG 0 to 1) \n\n Adequate liver, renal, and bone marrow function \n\n ", - "exclusion_criteria": " include: \n\n Pregnant or lactating women \n\n Treatment with more than one cytotoxic therapy \n\n Prior radiation to the whole pelvis \n\n Unstable medical conditions such as uncontrolled cardiac arrhythmia \n\n Patients with known history of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80", - "brief_summary": "The purpose of this study is to determine the effectiveness and safety of TLK286 given intravenously once every three weeks in combination with docetaxel (Taxotere) in the treatment of patients with non-small cell lung cancer that is resistant to platinum-based chemotherapy.", - "NCTID": "NCT00047801" - }, - { - "brief_title": "Ultrathin Bronchoscopy for Solitary Pulmonary Nodules", - "phase": "Phase 4", - "drugs": "['bronchoscopy']", - "drugs_list": [ - "bronchoscopy" - ], - "diseases": "['Lung Cancer']", - "diseases_list": [ - "Lung Cancer" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Pulmonary nodule on a recent CT \n\n non-visible on standard-size bronchoscopy \n\n ", - "exclusion_criteria": ": \n\n missing informed consent", - "brief_summary": "The evaluation of solitary pulmonary nodules (SPN) requires a balance between procedure-related morbidity and diagnostic yield, particularly in areas where tuberculosis is endemic. Data on ultrathin bronchoscopy (UB) for this purpose is limited. In this prospective randomised trial we compared diagnostic yield and adverse events of UB with standard-size bronchoscopy (SB) in a cohort of patients with SPN located beyond the visible range of SB.", - "NCTID": "NCT02490059" - }, - { - "brief_title": "Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Solitary Pulmonary Nodule']", - "diseases_list": [ - "Solitary Pulmonary Nodule" - ], - "enrollment": "400.0", - "inclusion_criteria": "inclusion criteria: \n\n Age> 18 years \n\n in patients with solitary pulmonary nodule \n\n who had percutaneous needle biopsy for diagnosis of lung nodule \n\n ", - "exclusion_criteria": ": \n\n patients who do not agree the study enrollment", - "brief_summary": "Among the causes of the solitary pulmonary nodule (SPN), benign causes including tuberculosis was noted on 15 to 60 percents in various studies.~Although the characteristics of chest imaging is helpful in diagnosis and percutaneous needle biopsy for pulmonary nodule has been represented high diagnostic yield in many reports, but still surgical biopsy has been needed in definite diagnosis of pulmonary nodules in many cases.~The aim of this study is to evaluate the usefulness of interferon-gamma release assay in addition to the percutaneous needle biopsy, in diagnosis of pulmonary nodules.", - "NCTID": "NCT01149187" - }, - { - "brief_title": "Sonography After Thoracic Surgery (SATS)", - "phase": "", - "drugs": "['thoracic ultrasound']", - "drugs_list": [ - "thoracic ultrasound" - ], - "diseases": "['Lung Cancer']", - "diseases_list": [ - "Lung Cancer" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients undergoing elective, open and thoracoscopic thoracic surgery for any indication \n\n ", - "exclusion_criteria": ": \n\n Age < 18 years old \n\n Inability to consent for the study \n\n Chest wall anatomy precluding SATS \n\n Inability to sit upright", - "brief_summary": "Lung cancer remains the leading cause of mortality from malignant diseases in both men and women worldwide. Following thoracic surgery and pulmonary resection, patients have a surgically induced pneumothorax / hydro-hemothorax and hence tube thoracostomy is necessary to drain the air and effusion. Due to this, patients must undergo post-operative chest x-ray (CXR) evaluations in order to evaluate the chest and make decisions regarding removal of chest tubes (CT) as well as for decisions regarding patient discharge. Thoracic Ultrasound (US) has been shown to be accurate at diagnosing pneumothorax and has been well-studied in the trauma population. To the investigators knowledge, there are currently no centers using thoracic US routinely in the post-operative setting following thoracic surgery.", - "NCTID": "NCT01152463" - }, - { - "brief_title": "To Determine the Maximum Tolerated Dose (MTD) of BIBF 1120 in Patients With Solid Tumours", - "phase": "Phase 1", - "drugs": "['BIBF 1120']", - "drugs_list": [ - "BIBF 1120" - ], - "diseases": "['Malignant Solid Tumour']", - "diseases_list": [ - "Malignant Solid Tumour" - ], - "enrollment": "61.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment \n\n Evaluable tumour deposits by one or more techniques (X-ray, CT, MRI, ultrasound) \n\n Age 18 years or older \n\n Life expectancy of at least three months \n\n Patients had to give written informed consent (which must be consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) and local legislation) \n\n Eastern Cooperative Oncology Group (ECOG) performance score < 2 \n\n Full recovery from all therapy-related toxicities from previous chemo-, hormone-,immuno-, or radiotherapy \n\n ", - "exclusion_criteria": ": \n\n History of relevant surgical procedures during the last four weeks prior to treatment with the trial drug, or active ulcers, or injuries with incomplete wound healing \n\n Pregnancy or breastfeeding \n\n Active infectious disease \n\n Brain metastases requiring therapy \n\n Absolute neutrophil count less than 1500 / mm3 \n\n Platelet count less than 100 000 / mm3 \n\n Bilirubin greater than 1.5 mg / dl (> 26 \u03bcmol / L, International System of Units (SI unit) equivalent) \n\n Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than three times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal) \n\n Serum creatinine greater than 1.5 mg / dl (> 132 \u03bcmol / L, SI unit equivalent) \n\n Uncontrolled, severe hypertension \n\n Gastrointestinal disorders anticipated to interfere with the resorption of the study drug \n\n Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol \n\n Women and men who are sexually active and unwilling to use a medically acceptable method of contraception \n\n Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug) \n\n Patients unable to comply with the protocol \n\n Active alcohol or drug abuse", - "brief_summary": "The primary objective of this study was to determine the maximum tolerated dose (MTD) of BIBF 1120 in patients with solid tumours by the monitoring of drug-related adverse events. Secondary objectives were the evaluation of safety, efficacy, pharmacokinetics, and pharmacodynamics.", - "NCTID": "NCT01951846" - }, - { - "brief_title": "Effects of Brain Stimulation on Learning and Reasoning", - "phase": "", - "drugs": "['Cadwell Rapid Rate Magnetic Stimulator']", - "drugs_list": [ - "Cadwell Rapid Rate Magnetic Stimulator" - ], - "diseases": "['Cerebellar Disease', 'Dementia', 'Healthy', \"Parkinson's Disease\"]", - "diseases_list": [ - "Cerebellar Disease", - "Dementia", - "Healthy", - "Parkinson's Disease" - ], - "enrollment": "122.0", - "inclusion_criteria": "inclusion criteria \n\n Right handed normal volunteers (18-65 years old). \n\n Patients with Parkinson's disease off medication. \n\n Patients with cerebellar deficits. \n\n Patients with frontal lobe lesions. \n\n Patients with frontal lobe dementia. \n\n ", - "exclusion_criteria": " \n\n Subjects with personal or family history of seizures or other neurological disorders. \n\n Pregnant women. \n\n Volunteers or patients with severe coronary artery disease. \n\n Metal in the cranium except mouth. \n\n Intracardiac lines. \n\n Increased intracranial pressure as evaluated by clinical means. \n\n Cardiac pacemakers. \n\n Intake of neuroleptics.", - "brief_summary": "Imaging studies of the brain have revealed the different areas involved in the processes of learning and reasoning. However, the specific role these regions play in these processes, or if stimulating these areas can improve these processes is unknown.~Researchers would like to use repetitive transcranial stimulation (rTMS) to better understand the roles of individual brain regions on the processes of learning and reasoning. Repetitive transcranial magnetic stimulation (rTMS) involves the placement of a cooled electromagnet with a figure-eight coil on the patient's scalp, and rapidly turning on and off the magnetic flux. This permits non-invasive, relatively localized stimulation of the surface of the brain (cerebral cortex). The effect of magnetic stimulation varies, depending upon the location, intensity and frequency of the magnetic pulses.~The purpose of this study is to use rTMS to help determine the roles of different brain regions in the development of implicit learning of motor sequences and analogic reasoning. In addition, researchers hope to evaluate if stimulation of these regions speeds up the process of learning or analogic reasoning.", - "NCTID": "NCT00001776" - }, - { - "brief_title": "Validation of Digital Chest-X-ray (CXR) to Assess Lung Recruitment in ARDS", - "phase": "", - "drugs": "['PEEP of 5 or 15 cm H2O']", - "drugs_list": [ - "PEEP of 5 or 15 cm H2O" - ], - "diseases": "['Acute Respiratory Distress Syndrome (ARDS)']", - "diseases_list": [ - "Acute Respiratory Distress Syndrome (ARDS)" - ], - "enrollment": "38.0", - "inclusion_criteria": "inclusion criteria: \n\n intubation and mechanical ventilation in the ICU \n\n Ramsay score 6 under sedation and analgesia \n\n ICU respirator implemented with pressure-volume curve device \n\n age equal to or greater than 18 years \n\n ARDS defined from the Berlin criteria \n\n absence of pneumothorax on the CXR before the study \n\n Absence of pleural effusion greater than 500 ml estimated from ultrasonography. \n\n no child-bearing woman \n\n written inform consent signed by the next of kin \n\n ", - "exclusion_criteria": ": \n\n Pneumothorax \n\n Pleural effusion greater than 500 ml estimated from ultrasonography \n\n Thoracic surgery in the last 3 months \n\n Contra-indication to CXR \n\n contra-indication to PEEP of 15 cm H2O \n\n contra-indication to PEEP of 15 or PEEP 15 mandated \n\n pressure-volume curve not feasible \n\n refusal to participate \n\n language barrier of the next of kin \n\n child-bearing woman \n\n person under legal protection", - "brief_summary": "Lung recruitability is essential for optimal Positive end-expiratory pressure (PEEP) selection in ARDS patients. It is defined as the potential for the non aerated or poorly aerated lung mass to become aerated due to the increase in airway pressure. PEEP contributes to lung recruitment mostly by maintaining some amount of the end-inspiratory recruitment at the end of expiration. PEEP also stabilizes patency of the small airways and minimizes the repeated opening and closing of them during the breathing cycle, which is implicated in a further lung inflammation. The gold-standard method for assessing lung recruitability is lung CT scan. For economic and feasibility this technique cannot be used in routine. Therefore, techniques that can be used at the bedside to measure lung recruitability are very well known. The measurement of recruited lung volume (Vrec) by using pressure-volume curve generated by the ventilator is another reference method to approach lung recruitment. It can be done at the bedside. Chest-X-Ray (CXR) is an interesting option as done in routine in this setting. Furthermore, it allows quantifying aeration thanks numerical image processing and a regional approach. In a preliminary one-center study we found a significant negative correlation between the amount of Vrec and the reduction in lung density measured by digital CXR between 5 and 15 cm H2O PEEP. In present study we would like to extend this previous result on a larger number of patients in a multicenter investigation.", - "NCTID": "NCT02081105" - }, - { - "brief_title": "Test of A Model of Representational Knowledge Stored in the Human Prefrontal Cortex", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Intracranial Central Nervous System Disorder', 'Mental Disorder', 'Healthy']", - "diseases_list": [ - "Intracranial Central Nervous System Disorder", - "Mental Disorder", - "Healthy" - ], - "enrollment": "949.0", - "inclusion_criteria": "INCLUSION AND ", - "exclusion_criteria": ": \n\n Controls: Healthy normal controls matched to specific patient groups for age, education, gender, and race to be recruited by advertisement from the community or from among friends and relatives of the patient. Individuals with a neurological or psychiatric history or medical condition that would compromise our interpretation of the test results will not be included. \n\n Patients: Patients will be selected from referrals to the Cognitive Neuroscience Section, the NIH Clinical Center, and from referrals recruited through approved advertisement in appropriate media and medical journals. \n\n All patients must have a diagnosed CNS disorder with lesions localization (when suspected) verified by CT or MRI scanning available from the referring physician or completed at the NIH Clinical Center. Subjects without neurological, neuropsychological, and imaging evidence compatible with one of the recruited diagnoses will be excluded from the study as will subjects who cannot cooperate with neuropsychological testing (based on family report and the report of the referring healthcare professional). \n\n The bulk of the patients recruited for this protocol will have focal or degenerative lesions of the HPFC. We also will recruit patients with non-frontal lesions in order to determine the specificity of the deficit we observe in patients with HPFC lesions. These patients will undergo the same testing but are not expected to have marked cognitive deficits on tests of frontal lobe function. \n\n Patients with different basal ganglia disorders or limbic system lesions are included because their lesions involve differing subsets of subcortical structures that are thought to play an important role in the automatic activation of stored plans and social behavior. Another prediction from the SEC model is that patients with basal ganglia disorders will have deficits primarily on over-learned components of tasks that require visuomotor interaction (e.g., a visuomotor serial reaction time task) but have spared performance on higher level cognitive planning tasks that don't require simple visuomotor responses. \n\n The bulk of the patients will be patients with focal penetrating head injuries who will be seen here at the NIH as part of a newly funded study to be conducted primarily, but not solely, at the National Naval Medical Center. Patients with dementing disorders (e.g., frontotemporal dementia) are suitable for assessment of the structure of knowledge, and in particular, the systematic general breakdown of social and non-social SEC knowledge representation. Patients with focal lesions (e.g., dorsolateral frontal) will be studied to assess damage to specific sub-components of the structured event complex model. Occasionally, single cases will be intensively studied due to a unique behavioral presentation (see above for a lengthier description). \n\n A durable power of attorney will be appointed if the patient is unable to make decisions about any or all aspects of this protocol. In the past in our protocols, this has almost always been the spouse. \n\n The age range of the brain-damaged patients will be determined on entrance into the protocol. An equal number of left and right unilateral lesions will be sought for determination of laterality differences. Patients with lesions limited to (rather than simply including) the frontal lobe will also be especially sought. \n\n Minors (ages 6-17) are included in this protocol in order to examine 3 specific questions: (1) What is the distinction in retrievable SEC knowledge (e.g., plans or social rules) learned prior to adolescence from that subsequent to adolescence?; (2) Does learning and development of all aspects of social cognition require an intact prefrontal cortex?; and (3) Will some effects of early prefrontal cortex lesions only appear after the age of 14? The first question will be addressed by studying healthy normal children before the age of 14 on experimental social cognition and planning tasks slightly modified from those used with adults (see the six studies described above). The second question will be addressed by studying single cases and groups of children with prefrontal cortex lesions on social cognition tasks before and after the age of 14. The third question will be addressed by studying children with prefrontal cortex lesions incurred before the age of 14 both before and after the age of 14 on social cognition, meta-cognition, and planning tasks.", - "brief_summary": "This study will examine the underlying mental processes that determine how people understand social behavior, remember information, and think. Language, planning, problem solving, reasoning, social behavior, and memory are the critical parts of cognition that make up daily life. This study will explore the association between performance on various experimental tasks and day-to-day functioning.~Healthy normal volunteers and patients with certain kinds of brain damage (primarily focal or degenerative lesions of the human prefrontal cortex) or psychiatric disorders may be eligible for this study. Candidates with central nervous system trauma, disease or dysfunction will be screened with a routine neurological examination and history.~Participants may be asked to complete written tests, sit in front of a computer monitor and press a key to indicate a decision about what appears on the screen (for example, whether a statement is accurate) and answer questions from a test examiner. A skin conductance response (SCR) test may be done along with some of the cognitive tests. SCR uses electrodes (pieces of metal attached to wires) placed on the fingers to measure the subject's emotional reaction to a test. Participants may also do an evoked response test, in which the subject watches words or scenes on a TV screen while his or her responses are recorded from electrodes placed on the scalp (similar to an electroencephalogram). The tests will be scheduled for an average of one session a week, with each session lasting from 30 minutes to 3 hours. Generally, 15 sessions will be scheduled over a 1-year period. Special arrangements will be made to accommodate participants from out-of-town.~Participants may have a magnetic resonance imaging (MRI) scan of the brain. This test uses radio waves and a strong magnetic field to picture structural and chemical changes in tissue. For the procedure, the subject lies on a table in a space enclosed by a metal cylinder (the scanner) for about 1 hour.~In addition, some study subjects will be invited to participate in a training study designed to improve their planning or social behavior. Participation requires coming to NIH daily over a 1- to 2-month period for 1 to 2 hours each visit.", - "NCTID": "NCT00024908" - } - ], - "2": [ - { - "brief_title": "Lung Cancer Location: a Repository", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Lung Cancer']", - "diseases_list": [ - "Lung Cancer" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects undergoing EUS evaluation of a mediastinal mass, or suspected/known lung cancer \n\n Subjects with a prior history of lung cancer \n\n Subjects referred to thoracic surgery for evaluation of a suspected/known lung cancer \n\n ", - "exclusion_criteria": ": \n\n Altered mental status that would prohibit the giving and understanding of informed consent \n\n Dementia \n\n Psychiatric illness that would preclude adequate compliance with communication for this protocol \n\n Prisoners", - "brief_summary": "The purpose of this repository is to prospectively examine subjects with known or suspected lung cancer to determine the extent of mediastinal lymph node involvement with respect to primary lung cancer location. The data collected in this repository may be used to influence our current standard of care and streamline indications for EUS.", - "NCTID": "NCT00578084" - }, - { - "brief_title": "Low-dose Computed Tomography Screening for Lung Cancer in Relatives With Family History of Lung Cancer", - "phase": "", - "drugs": "['low dose computed tomography']", - "drugs_list": [ - "low dose computed tomography" - ], - "diseases": "['Lung Cancer']", - "diseases_list": [ - "Lung Cancer" - ], - "enrollment": "1102.0", - "inclusion_criteria": "inclusion criteria: \n\n relatives of the lung cancer patients; \n\n age older than 55 years old or age older than the age of onset of lung cancer proband if the family members were less than 55 years old; \n\n compulsory signing the consent agreement after understanding the purpose of study and the exposure of radiation. \n\n ", - "exclusion_criteria": ": \n\n proved lung cancer either with or without treatment, \n\n presence of hemoptysis or history of remarkable lung fibrosis, \n\n any other cancer history or \n\n chest CT examination within one year", - "brief_summary": "Screening with the use of low-dose computed tomography (LDCT) reduces mortality from lung cancer. Relatives with family history of lung cancer are at increased risk of lung cancer compared to those without a family history in pooled analysis. A prospective trial using LDCT of lung to screen the relatives with family history of lung cancer is needed.", - "NCTID": "NCT02519972" - }, - { - "brief_title": "Extracolonic Findings on Computed Tomography (CT) Colonography", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Solitary Pulmonary Nodules', 'Multiple Pulmonary Nodules', 'Renal Neoplasms', 'Adrenal Gland Neoplasms', 'Aortic Aneurysm, Abdominal', 'Liver Neoplasms', 'Adnexal and Skin Appendage Neoplasms', 'Lymphadenopathy', 'Pancreatic Neoplasms']", - "diseases_list": [ - "Solitary Pulmonary Nodules", - "Multiple Pulmonary Nodules", - "Renal Neoplasms", - "Adrenal Gland Neoplasms", - "Aortic Aneurysm", - "Abdominal", - "Liver Neoplasms", - "Adnexal and Skin Appendage Neoplasms", - "Lymphadenopathy", - "Pancreatic Neoplasms" - ], - "enrollment": "520.0", - "inclusion_criteria": "No participant sub-populations will be excluded prior to selection (the E1 population will be matched to the Case Group populations). \n\n Data from the 15 participating sites from the ACRIN 6664 trial provide a study data set of 2531 participants, broken down into a total target study data set of 520 participants. Participants will be distributed into one of three cohorts as follows: \n\n The Case Group will target consenting 141 participants from the cases with indeterminate but potentially significant findings (E3/E4s) other than pulmonary nodules. \n\n The Pulmonary Nodules Case Group will comprise 119 cases with E3/E4 ECFs characterized as pulmonary nodules. \n\n The E1 Control Group will be drawn from the 866 E1 ECF cases to create a cohort of 260 E1ECF cases. The Control Group for comparison with the Case Group and the Pulmonary Nodules Case Group will be selected at the Biostatistics and Data Management Center (BDMC). The BDMC will match E1 141 controls to the 141 case-group participants with indeterminate but potentially significant findings (E3/E4s). The BDMC will also match 119 E1 controls to the 119 E3/E4 pulmonary nodules cases. Controls will be matched by site, age caliper (5 years), and sex where possible. Where an appropriate match cannot be obtained, the matching criteria will be relaxed. If potential participants decline study consent, we will then best-match additional cases for the appropriate group to maintain target populations. Any additional cases beyond the initial 520 participants identified for medical record collection will be matched as feasible.", - "exclusion_criteria": "", - "brief_summary": "The ACRIN 7151 trial will use medical records abstraction data from participants with extracolonic findings (ECFs) reported from the ACRIN 6664 National CT Colonography Trial to: 1) measure incidence of diagnostic imaging, hospitalization, and interventional procedures associated with ECFs reported on computed tomography colonography (CTC), delineated by type of ECF; 2) determine potential predictors of follow-up diagnostic imaging, hospitalization, and interventional procedures, delineated by type of ECF; and 3) evaluate the clinical/pathologic diagnoses associated with indeterminate but potentially significant ECFs. These data can be used to incorporate ECFs into existing models on the cost-effectiveness of CTC in colorectal cancer screening and can potentially be used to develop guidelines for the reporting and management of ECFs.", - "NCTID": "NCT01465425" - }, - { - "brief_title": "A Trial Comparing Radiosurgery With Surgery for Solitary Brain Metastases", - "phase": "Phase 3", - "drugs": "['Surgery + WBRT', 'Radiosurgery + WBRT']", - "drugs_list": [ - "Surgery + WBRT", - "Radiosurgery + WBRT" - ], - "diseases": "['Neoplasm Metastasis', 'Brain Neoplasm']", - "diseases_list": [ - "Neoplasm Metastasis", - "Brain Neoplasm" - ], - "enrollment": "22.0", - "inclusion_criteria": "inclusion criteria: \n\n Single presumed brain metastasis on contrast magnetic resonance imaging (MRI) scan within two weeks before commencement of treatment. \n\n Systemic cancer diagnosed histologically or cytologically synchronous with, or within 5 years of treatment of the presumed brain metastasis (other than non-melanoma skin cancer and cancer in-situ of the cervix, neither of which would be reasonably attributable as the primary site). Exception - melanoma diagnosed > 5 years previously is allowable in view of the extremely variable natural history of melanoma. \n\n Age >= 18 (no upper age limit). \n\n Considered suitable for both S and RS by the neurosurgeon and radiation oncologist (see exclusions). \n\n Patient must agree to adjuvant WBRT. \n\n RTOG RPA Class 1 or 2 (Karnofsky Performance Status [KPS] >= 70 after adequate trial of corticosteroids). \n\n RPA Class 3 patients (KPS < 70) eligible if it is considered that the poor performance status is due primarily to the solitary metastasis, aggressive local treatment of which may be expected to restore good performance status. This would ordinarily be associated with minimal systemic disease burden. \n\n Accessible for treatment and follow-up. \n\n Patient is infertile or is aware of the risk of becoming pregnant or fathering children and will use adequate contraception. \n\n Written informed consent \n\n ", - "exclusion_criteria": ": \n\n Previous history of brain metastasis(es) \n\n Surgery indicated to relieve life-threatening raised intracranial pressure or excision required for tissue diagnosis (no extra-cranial site to biopsy ie unknown primary). However, prior diagnostic (non-excisional) biopsy is allowable - it is acknowledged that the 50% probability of a repeat surgical procedure on subsequent randomisation would not be acceptable to many patients and clinicians. \n\n Surgery contraindicated by site (e.g. thalamus, brain stem) or medical co-morbidities. \n\n Leptomeningeal disease. \n\n Primary is small cell lung cancer, germ cell tumour, lymphoma, leukaemia or myeloma. \n\n Prior cranial RT (including RS). \n\n Patient is pregnant.", - "brief_summary": "This study examines surgery versus radiosurgery (highly focussed radiation) for the treatment of cancer which has spread to one spot in the brain (solitary brain metastasis). For these two treatment options, it will compare patients' survival times, quality of life, control rate of the brain metastases and side effects. It uses the most rigorous scientific method available called randomisation which minimises biases that exist with other types of studies. It will involve 30 - 40 patients.", - "NCTID": "NCT00124761" - }, - { - "brief_title": "Evaluating the Pulmonary Nodule With Imaging and Biomarkers", - "phase": "", - "drugs": "['Olympus Ultrathin Bronchofibervideoscope (XP260F)']", - "drugs_list": [ - "Olympus Ultrathin Bronchofibervideoscope (XP260F)" - ], - "diseases": "['Lung Cancer']", - "diseases_list": [ - "Lung Cancer" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients aged above 21 years, capable of giving consent and suspected of lung cancer with radiological lung nodules and masses. \n\n ", - "exclusion_criteria": ": \n\n Patients with contra-indications to bronchoscopy and CT-TTNA that include active myocardial ischemia, uncorrected coagulopathy, severe respiratory distress, uncontrollable cough, and pregnancy will be excluded. Before females in the reproductive age are recruited, urine pregnancy test will be performed and confirmed negative.", - "brief_summary": "The study aims to determine if there are defining EBUS and confocal endoscopy features as well as exhaled alveolar gas VOC that can discriminate malignant pulmonary nodules or masses from benign etiology, thereby obviating unnecessary thoracotomy. Directly sampled alveolar gas VOC from patients with lung cancer will be compared against exhaled breath VOC for signature compounds that may complement CT in screening the population at risk.", - "NCTID": "NCT01739881" - }, - { - "brief_title": "Protein and RNA Expression Patterns in Predicting Response to Treatment in Patients With Lung Cancer", - "phase": "", - "drugs": "['DNA/RNA sequencing and expression levels', 'Protein expression analysis', 'Lung tumor biopsy', 'Blood sample']", - "drugs_list": [ - "DNA/RNA sequencing and expression levels", - "Protein expression analysis", - "Lung tumor biopsy", - "Blood sample" - ], - "diseases": "['Lung Cancer']", - "diseases_list": [ - "Lung Cancer" - ], - "enrollment": "204.0", - "inclusion_criteria": "inclusion criteria \n\n Diagnosis of suspected lung cancer or lung cancer \n\n ", - "exclusion_criteria": " \n\n Inability to undergo therapy", - "brief_summary": "RATIONALE: Studying samples of tumor tissue and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in genetic material (DNA and RNA) and may also identify protein expression patterns related to cancer. It may also help doctors predict how patients will respond to treatment.~PURPOSE: This research study evaluates changes in DNA, RNA, and proteins with the goal of predicting response to treatment in patients with lung cancer.", - "NCTID": "NCT00897650" - }, - { - "brief_title": "The Prevalence of Lung Cancer in Patients With Interstitial Lung Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Lung Diseases, Interstitial', 'Lung Cancer']", - "diseases_list": [ - "Lung Diseases", - "Interstitial", - "Lung Cancer" - ], - "enrollment": "1375842.0", - "inclusion_criteria": "inclusion criteria: \n\n equal to above 40 years old \n\n ", - "exclusion_criteria": ": \n\n none", - "brief_summary": "The investigators will evaluate the prevalence of lung cancer associated with interstitial lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) utilizing the Korean Health Insurance Review and Assessment Service (HIRA) database, spanning the period from January 2011 to December 2011. The database (HIRA-NPS-2011-0001) was based on random sampling of outpatients from whole population. Patients with ILDs, IPF, connective tissue disorder (CTD), and COPD were identified based on the International Classification of Disease-10 (ICD-10) diagnostic codes.", - "NCTID": "NCT02501668" - }, - { - "brief_title": "A Study of the Interaction Between Tumor Susceptibility Gene Glycine N-methyltransferase (GNMT) and Lung Cancer", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Lung Cancer']", - "diseases_list": [ - "Lung Cancer" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Participant is a lung cancer patient. \n\n ", - "exclusion_criteria": ": \n\n Participant is under 18 years old. \n\n Participant is not a lung cancer patient.", - "brief_summary": "Environmental carcinogens such as polycyclic aromatic hydrocarbons (PAHs) were reviewed as the major risk factors for lung cancer development. In this proposal, the investigators collected fifteen kinds of major PAHs and the investigators would like to perform the following studies:~Study the gene expression and subcellular localization of GNMT in the normal-tumor tissue pairs of lung cancer patients.~Study the associations of the polymorphisms of GNMT in lung cancer patients and the susceptibility to lung cancer;~To assess the allelic loss at GNMT and determined the LOH rate of GNMT in the normal-tumor tissue pairs of lung cancer patients.~Study the associations of the copy number variation (CNV) of GNMT and the susceptibility to lung cancer;~Study the interaction between GNMT and polycyclic aromatic hydrocarbons (PAHs) in lung cancer cell lines.", - "NCTID": "NCT01452971" - }, - { - "brief_title": "Feasibility Study Using Imaging Biomarkers in Lung Cancer", - "phase": "", - "drugs": "['Imaging Biomarkers']", - "drugs_list": [ - "Imaging Biomarkers" - ], - "diseases": "['Lung Cancer']", - "diseases_list": [ - "Lung Cancer" - ], - "enrollment": "225.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects of all races and ethnic origins over 18 years of age will be recruited. \n\n Patients must have suspicious or known to be malignant solitary pulmonary nodule,5cm or less in size. \n\n ", - "exclusion_criteria": ": \n\n Patients with a contraindication to MRI examinations will be excluded from this study. \n\n Contraindications to MRI examinations include: \n\n Medically unstable \n\n Heart failure \n\n Unstable angina \n\n Child bearing \n\n Lactating \n\n Not a surgical candidate \n\n Any contraindication per MRI Screening Form (Appendix A attached). This is the same form used in clinical practice at UT Southwestern. \n\n Titanium implants, pacemakers \n\n Poorly controlled diabetes \n\n Body weight greater than 300 pounds \n\n Claustrophobic \n\n Since each patient is receiving a gadolinium based contrast agent intravenously: \n\n eGFR < 45 mL/min/1.73m2 \n\n Sickle cell disease \n\n Hemolytic anemia", - "brief_summary": "The purpose of this research study is to develop a method of using magnetic resonance imaging (MRI) to evaluate solitary pulmonary nodules (mass in the lung smaller than 3 centimeters). A pulmonary nodule is a mass or growth on the lung. An MRI is a scanning device that uses magnets to make images (pictures) of the body. This study is being done to determine what series of reactions (metabolic pathways) pulmonary nodules use as they burn sugar as fuel for growth. The manner in which the tumor burns (metabolizes) sugar for fuel is being investigated by using a natural, slightly modified, sugar solution (13C-glucose) and studying a small sample of the tumor once it is removed at the time of surgery.", - "NCTID": "NCT02095808" - }, - { - "brief_title": "GE Healthcare VolumeRAD Lung Nodule Detection Study", - "phase": "", - "drugs": "['Chest tomosynthesis and X-ray']", - "drugs_list": [ - "Chest tomosynthesis and X-ray" - ], - "diseases": "['Pulmonary Nodule, Solitary', 'Multiple Pulmonary Nodules']", - "diseases_list": [ - "Pulmonary Nodule", - "Solitary", - "Multiple Pulmonary Nodules" - ], - "enrollment": "187.0", - "inclusion_criteria": "inclusion criteria: \n\n Scheduled for chest CT as part of their needed medical care; \n\n If available, individuals who have had previous imaging to suggest they fulfill the needs of the study; \n\n 18 years of age, or older; \n\n In good enough physical condition to stand motionless and hold their breath during the image acquisition procedures. \n\n ", - "exclusion_criteria": ": \n\n Children under 18 years of age; \n\n Women who are pregnant or who suspect they may be pregnant; \n\n Individuals who on previous imaging are shown to have objects in or around the lungs that might produce substantial artifacts that would obscure pulmonary nodules; \n\n Individuals who on recent imaging had active lung or pleural disease that would obscure pulmonary nodules; \n\n Individuals with more than 5 pulmonary nodules between 5mm and 20mm in diameter in either right or left lung. \n\n Individuals suspected to have more than 15 total nodules between 3mm and 20mm. NOTE that up to 20 nodules between 3mm and 20mm will be allowed in the final study sample.", - "brief_summary": "To perform a multiple reader, multiple case (MRMC) observer study assessing the detection performance of VolumeRAD tomosynthesis of the chest in detecting lung nodules.", - "NCTID": "NCT00963651" - }, - { - "brief_title": "Studies of Temozolomide in Combination With Topotecan in Refractory and Relapsed Paediatric Solid Tumours", - "phase": "Phase 2", - "drugs": "['Temozolomide/Hycamtin (Topotecan)']", - "drugs_list": [ - "Temozolomide/Hycamtin (Topotecan)" - ], - "diseases": "['Neuroblastoma', 'Brain Tumors', 'Solid Tumors']", - "diseases_list": [ - "Neuroblastoma", - "Brain Tumors", - "Solid Tumors" - ], - "enrollment": "129.0", - "inclusion_criteria": "inclusion criteria: \n\n Histologically or cytologically confirmed neuroblastoma, brain tumor or other solid tumor (at diagnosis) \n\n Relapsed or refractory tumors in which correct standard treatment approaches have failed \n\n No more than 2 lines of prior chemotherapy \n\n Measurable primary and/or metastatic disease on CT/MRI at least one bi-dimensionally measurable lesion. \n\n For patients with neuroblastoma, measurable disease will be defined by the modified International Neuroblastoma Staging System (Brodeur et al.1993) completed with MIBG scoring. \n\n Age at inclusion: 6 months to \u2264 20 years \n\n Lansky play score \u2265 70% or ECOG performance status \u2264 1 \n\n Life expectancy \u2265 3 months \n\n Adequate organ function: \n\n Adequate haematological function: haemoglobin \u2265 80 g/l, neutrophil count \u2265 1.0 x 109/L, platelet count \u2265 100 x 109/L; in case of bone marrow disease: neutrophils \u2265 0.5 x 109/l and platelets \u2265 75 x 109/l; \n\n Adequate renal function: normal creatinine related to patient's age: \n\n 0 - 1 year: \u2264 40 \u00b5mol/L \n\n 1 - 15 years: \u2264 65 \u00b5mol/L \n\n 15 - 20 years: \u2264 110 \u00b5mol/L Adequate hepatic function: bilirubin \u2264 1.5 x ULN; AST and ALT \u2264 2.5 x ULN (AST, ALT \u22645xULN in case of liver metastases) \n\n Wash-out of 4 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas, 2 weeks in case of vincristine alone; 6 weeks in case of prior radiotherapy (except palliative radiotherapy on non measurable lesions). Patients must have recovered from the acute toxic effects of all prior therapy before enrolment into the study. \n\n Patients previously treated with only one of the 2 drugs are eligible. \n\n Able to comply with scheduled follow-up and with management of toxicity. \n\n All patients with reproductive potential must practice an effective method of birth control while on study. Female patients aged > 12 years must have a negative pregnancy test within 7 days before study treatment. \n\n Written informed consent from patient, parents or legal guardian. \n\n ", - "exclusion_criteria": ": \n\n Concurrent administration of any other anti-tumour therapy. \n\n Serious concomitant systemic disorder (for example, active infection including HIV or cardiac disease) that in the opinion of the investigator, would compromise the patient's ability to complete the study. \n\n History of allergic reaction to the compounds or their solvents. \n\n History of allergic reaction to Dacarbazine (DITC). \n\n Galactosemia, Glucose-galactose malabsorption or lactase deficiency. \n\n Pregnant or breast feeding young women. \n\n Presence of symptomatic brain metastases in patients with solid non-CNS tumors.", - "brief_summary": "The purpose of the study is to determine whether the combination of Hycamtin (Topotecan) and Temozolomide is effective in the treatment of relapsed and refractory neuroblastoma and other paediatric solid tumors.", - "NCTID": "NCT00918320" - } - ] - }, - { - "patient_id": "sigir-20144", - "patient": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", - "0": [ - { - "brief_title": "Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease", - "phase": "", - "drugs": "['Cardiac evaluation']", - "drugs_list": [ - "Cardiac evaluation" - ], - "diseases": "['Kawasaki Disease']", - "diseases_list": [ - "Kawasaki Disease" - ], - "enrollment": "43.0", - "inclusion_criteria": "inclusion criteria: \n\n History of KD before the age of 18, with or without macroscopic coronary lesions in the childhood phase. (KD group only) \n\n 18 years old or older at the time of the study. \n\n Agree on participating to all explorations of the study. \n\n Accept genotyping. \n\n Absence of cardiovascular risk factors \n\n ", - "exclusion_criteria": ": \n\n Atypical KD (KD group only) \n\n Documented or suspected coronary ischemia, \n\n Refusal to participate to the study or sign the consent \n\n Contra-indication to the injection of iodinated contrast agents (allergy, renal failure) \n\n Hypersensitivity to dobutamine, \n\n No effective contraception method for females with child bearing potential, \n\n Breastfeeding, or pregnant females, \n\n Treatment modifying endothelial reactivity \n\n History of severe intolerance to iodinated contrast agents, \n\n Subjects who can't hold their breath for at least 20 seconds, \n\n Irregular or absence of sinus rhythm, especially atrial or ventricular arrhythmia \n\n Unability to give information to the subject, \n\n No coverage from a Social Security system \n\n Deprivation of civil rights", - "brief_summary": "Kawasaki disease (KD) is an acute systemic vasculitic syndrome with coronary tropism.~It has been reported worldwide, but it is ten times more common in Asian population. The annual incidence in children under 5 years in Europe is estimated at 8 to 100000. It is the second vasculitis of the child by its frequency after rheumatoid purpura. It occurs in 80% of cases between 1 and 5 years, with a maximal incidence around the age of 12 months.~It may results in acquired heart disease in children in developed countries, and may be the cause of premature coronary artery disease in adulthood.~A polymorphism was recently associated with the occurrence of disease in a Japanese and U.S population. (C allele of SNP itpkc_3, with a risk multiplied by 2). However, data are conflicting on this issue and the prevalence of this allel is unknown in North America and Europe populations.~The clinical picture of KD associate a persistent fever and an antipyretics resistance with mucocutaneous signs and bulky cervical lymphadenopathy usually unilateral. Diagnosis is confirmed by the presence of five clinical signs (major criteria). The presence of inconsistent coronary lesions in cardiac ultrasound can confirm the diagnosis.~KD can resolve spontaneously with no treatment. The severity of the disease is primarily related to complications of coronary aneurysms in acute or chronic stages.~Several arguments support the fact that adult patients have diffuse vascular lesions different from aneurysmal lesions initially described in childhood.~Despite abundance of publications on KD, there is no prospective or retrospective study which explored anomalies resulting from KD in adult subjects.~Therefore, this project will describe the patient's vascular evolution, the prevalence of atherosclerotic lesions and to determine the biological and functional abnormalities, markers of accelerated atherosclerosis.~Hypothesis : A history of Kawasaki disease represents a cardiovascular risk factor in adulthood.~The main objective is to evaluate the prevalence of atherosclerotic lesions, their extent and their severity in adults with a history of KD in childhood compared to a control population.", - "NCTID": "NCT01440075" - }, - { - "brief_title": "A Study to Evaluate the Use and Safety of CARDIOLITE\u00ae in Pediatric Patients With Kawasaki Disease", - "phase": "Phase 3", - "drugs": "['Sestamibi']", - "drugs_list": [ - "Sestamibi" - ], - "diseases": "['Kawasaki Disease']", - "diseases_list": [ - "Kawasaki Disease" - ], - "enrollment": "445.0", - "inclusion_criteria": "inclusion criteria: \n\n Males or females between 4 and 16 \n\n Meet the epidemiological definition of Kawasaki Disease or have a diagnosis of incomplete KD, including evidence of coronary artery disease as determined by their physician. \n\n Be able to exercise adequately to achieve 85% age predicted maximum heart rate \n\n ", - "exclusion_criteria": ": \n\n Terminal illness where expected survival is < 6 months", - "brief_summary": "Determine the predictive value of CARDIOLITE\u00ae rest and stress myocardial perfusion imaging (MPI) to define a pediatric population with Kawasaki Disease (KD) at high and low risk of developing cardiac events.", - "NCTID": "NCT00162032" - }, - { - "brief_title": "Cardiovascular Risk Markers and Response to Statins After Kawasaki Disease", - "phase": "Phase 2", - "drugs": "['pravastatin']", - "drugs_list": [ - "pravastatin" - ], - "diseases": "['Kawasaki Disease']", - "diseases_list": [ - "Kawasaki Disease" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n History of Kawasaki disease more than 12 months before enrollment \n\n Present age of 8 years or older \n\n ", - "exclusion_criteria": ": \n\n Diabetes mellitus \n\n Not controlled hypertension \n\n Treatment with drugs thay modify endothelial function such as angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists, and calcium channel blockers \n\n Smokers of more than 5 cigarettes per day \n\n Total cholesterol higher than 250 mg/dl \n\n Triglycerides higher than 300mg/dl \n\n Chronic treatment with statins \n\n Chronic renal insufficiency (creatinine > 1.5 mg/dl)", - "brief_summary": "The purpose of this study is to determine whether Chilean children with history of Kawasaki disease have endothelial dysfunction years after the acute phase of the disease, and if this condition can be modified by treatment with statins.", - "NCTID": "NCT00305201" - }, - { - "brief_title": "An Open Phase 3 Study of IV-Globulin SN Inj.10% to Treat Immune Thrombocytopenia", - "phase": "Phase 3", - "drugs": "['Human immunoglobulin intravenous']", - "drugs_list": [ - "Human immunoglobulin intravenous" - ], - "diseases": "['Immune Thrombocytopenia']", - "diseases_list": [ - "Immune Thrombocytopenia" - ], - "enrollment": "81.0", - "inclusion_criteria": "inclusion criteria: \n\n Given written informed consent \n\n Male or female aged \u2265 19 \n\n Primary immune thrombocytopenia (ITP) \n\n Platelet <20x10^9 /L \n\n Patients who have taken adrenal cortical hormones and/or other immunosuppressive medications should maintain their stable doses before and during this study \n\n ", - "exclusion_criteria": ": \n\n Patients who have participate in other interventional study within 30 days \n\n Inability in written/verbal communication \n\n Engaged with an elective surgery \n\n Pregnant or breast-feeding women \n\n Women of childbearing potential who do not agree with contraception during this study \n\n Patients who had experienced any hypersensitivity or shock with study drug or active ingredient \n\n Refractory to immunoglobulin therapy \n\n Secondary immune thrombocytopenia \n\n HIV-associated ITP \n\n Lupus-associated ITP \n\n Lymphproliferative disease \n\n Hepatitis virus carrier \n\n Other disease- or infection-associated ITP \n\n Drug-Induced ITP \n\n Hereditary thrombopenia (e.g., MYH9 disorders) \n\n Hemolytic anemia (Positive direct Coomb's test) \n\n Clinically significant abnormalities of immunoglobulin \n\n Immunoglobulin A Deficiency \n\n Immune disorders or deficiency \n\n Alcohol or drug abuse within 6 months \n\n Patients who had taken any medications which may effect platelet function or count for at least 2 days prior study entry \n\n Patients who had administrated with IVIg or anti-D immunoglobulin agents within 1 month \n\n Patients who had undergone a splenectomy within 2 months \n\n Clinically significant underlying disease or medical history at investigator's discretion", - "brief_summary": "Human immunoglobulin (Ig) is the most commonly used blood product. It has been well-defined the efficacy in patients with immunodeficiencies, Kawasaki disease, asthma and other immune diseases. It is expected that Ig 10% will improve the usefulness and safety profile compared to Ig 5% because it is expected the reduced hospitalization/treatment duration and less adverse events related to volume overload.", - "NCTID": "NCT02063789" - }, - { - "brief_title": "APC-231 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) in Pediatric Patients With Strep Throat", - "phase": "Phase 3", - "drugs": "['Amoxicillin Pulsatile Release Multiparticluate Sprinkle']", - "drugs_list": [ - "Amoxicillin Pulsatile Release Multiparticluate Sprinkle" - ], - "diseases": "['Pharyngitis']", - "diseases_list": [ - "Pharyngitis" - ], - "enrollment": "500.0", - "inclusion_criteria": "inclusion criteria: \n\n Give informed consent, assent, and documentation of patient authorization for disclosure of study results. \n\n Since all patients are below the legal age of consent, assent from the patient must be obtained (as applicable following state regulations) and written informed consent obtained from the parent or legal guardian. \n\n Age > = 6 months -12 years. \n\n A clinical diagnosis of acute tonsillitis and/or pharyngitis defined as having the clinical signs and symptoms compatible with tonsillitis and/or pharyngitis, including sore throat or difficulty feeding or swallowing or irritability that suggests the presence of a sore throat with at least one of the following: \n\n Tonsillar or pharyngeal exudate \n\n Tender cervical lymph nodes \n\n Fever or history of fever treated with antipyretics \n\n Odynophagia \n\n Uvular edema \n\n Pharyngeal Erythema of moderate or greater intensity \n\n Elevated white blood cell (WBC) >12,000/mm3 or \uf0b310% bands \n\n Red tongue and prominent papillae (Strawberry tongue) \n\n A positive rapid screening test for S. pyogenes (enzyme immunoassay; SiGNIFY\u2122 Strep A Test). \n\n Patient is an appropriate candidate for oral antibiotic therapy and can swallow the study dosage forms. \n\n Females must be non-lactating and: \n\n If of childbearing potential and sexually active, the patient must have a negative prestudy urine pregnancy test and be utilizing acceptable birth control methods throughout the study. \n\n ", - "exclusion_criteria": ": \n\n Chronic or recurrent (two weeks duration two times per year) odynophagia or enlarged tonsils secondary to viral or proven bacterial etiology. \n\n The need for hospitalization or I.V. antimicrobial therapy. \n\n Pharyngitis known or suspected to be due to a pathogen resistant to beta-lactam antimicrobials. \n\n Patients who are known carriers of S. pyogenes. \n\n Previous allergy, serious adverse reaction to, or intolerance to, penicillin or any other member of the beta-lactam class of antimicrobials. \n\n Any serious illness or concomitant condition that the investigator judges would preclude the study evaluations or make it unlikely that the course of study therapy and follow-up could be completed. This would also include: \n\n Any rapidly progressive underlying disease with a shortened life expectancy. \n\n The inability to swallow the study dosage form. \n\n Unable to understand the requirements of the study. \n\n Neutropenia (<1000 PMNs/mm3) or other known immunocompromised state. \n\n Hard chills or rigors. \n\n Seizure disorder or lowered seizure threshold. This does not exclude children with previous febrile seizures. \n\n Psychiatric condition requiring use of major tranquilizers. \n\n Pregnancy or nursing. \n\n Expectation that additional effective systemic antibacterials would be required for any condition during the duration of the study. \n\n Current drug or alcohol abuse. \n\n Receipt of any experimental drug or medical device within the previous 30 days (or are scheduled to receive any other experimental procedures during the study period). \n\n Previous treatment under this protocol. \n\n Systemic antimicrobial therapy with benzathine penicillin within 30 days or azithromycin within 14 days. \n\n Hospitalization within the month prior to study admission, during which antibacterial therapy was administered. \n\n The presence of clinically significant hematologic conditions or cardiac valvular disease. \n\n History of cardiovascular disease, renal disease, or neurological disease secondary to previous infection with S. pyogenes. \n\n Probenecid treatment or systemic steroids during the duration of the study.", - "brief_summary": "The purpose of this study is to evaluate the efficacy and safety of APC-231 QD for 7 days in the bacteriological outcome at the Test of Cure Visit.", - "NCTID": "NCT00100126" - }, - { - "brief_title": "A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children", - "phase": "Phase 3", - "drugs": "['amoxicillin', 'azithromycin SR']", - "drugs_list": [ - "amoxicillin", - "azithromycin SR" - ], - "diseases": "['Tonsillitis']", - "diseases_list": [ - "Tonsillitis" - ], - "enrollment": "693.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who had evidence of acute pharyngitis/tonsillitis based on erythematous pharyngeal mucosa or thick exudate covering the pharynx and tonsillar area, and at least one of the following signs or symptoms were included: sore/scratchy throat; pain on swallowing; chills and/or fever cervical adenopathy; scarlet fever rash on the face and skin folds, or red tongue with prominent papillae (strawberry tongue). Subjects were required to have a positive rapid antigen detection test (RADT) or a positive culture of the pharynx or tonsils for GABHS. \n\n ", - "exclusion_criteria": ": \n\n Patients were excluded if they had previously diagnosed disease(s) of immune function or treatment with any systemic antibiotic within the previous 7 days.", - "brief_summary": "The objective was to determine if a single 60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin (45 mg/kg/day, given in divided doses every 12 hours) when used to treat children with strep throat.", - "NCTID": "NCT00643149" - }, - { - "brief_title": "Intravenous Immunoglobulin for PANDAS", - "phase": "Phase 3", - "drugs": "['Gamunex Intravenous Immunoglobulin', 'Placebo']", - "drugs_list": [ - "Gamunex Intravenous Immunoglobulin", - "Placebo" - ], - "diseases": "['Obsessive-Compulsive Disorder', 'Children', 'Anxiety Disorder', 'Autoimmune Disease', 'PANDAS']", - "diseases_list": [ - "Obsessive-Compulsive Disorder", - "Children", - "Anxiety Disorder", - "Autoimmune Disease", - "PANDAS" - ], - "enrollment": "48.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female children 4-13 years of age. \n\n Presence of (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision) DSM-IV TR OCD with or without a tic disorder. \n\n Moderate or greater severity of symptoms, with a score of greater than or equal to 20 on the Children s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) and greater than or equal to 4 on the Clinical Global Impression Severity scale (CGI-S). \n\n The acute onset within the previous six months of symptoms in a child previously well, or the first acute recurrence within the previous six months, after a period of relatively complete remission of symptoms. The acuity of symptom onset/exacerbation is key and must be severe, dramatic in onset, and proceed from no/minimal symptoms to maximum severity within 24-48 hours. \n\n Symptom onset or first exacerbation preceded within four months by a GAS infection, as documented by positive throat culture, exposure to documented GAS infection (in a close contact, such as a sibling sharing a bedroom), and/or documented two-fold rise in one or more anti-GAS antibody titers such as anti-streptolysin O, anti-streptococcal DNAaseB, anti-carbohydrate antibodies and others. \n\n Onset/exacerbation of OCD is accompanied by at least three of the following 7 clinical signs and symptoms. The acuity of the comorbid symptoms must be similar to the OCD symptoms and occur in the same time interval. \n\n Markedly increased level of anxiety, particularly new onset of separation anxiety. \n\n Emotional lability, irritability, aggressive behavior and/or personality change. \n\n Sudden difficulties with concentration or learning. \n\n Developmental regression (baby-talk, temper tantrums; behaviors atypical for actual chronological age). \n\n Sleep disorder (insomnia, night terrors, refusal to sleep alone). \n\n Handwriting deterioration or other sign of motoric dysfunction (including new onset of motor hyperactivity, or presence of choreiform finger movements). \n\n Urinary frequency or increased urge to urinate; daytime or night-time secondary enuresis. \n\n ", - "exclusion_criteria": ": \n\n History of rheumatic fever, including Sydenham chorea (the neurologic manifestation). \n\n Presence of symptoms consistent with autism, schizophrenia, or other psychotic disorder (unless psychotic symptoms have onset coincident with the possible PANDAS and are attributed to OCD). \n\n Presence of a neurological disorder other than a tic disorder. \n\n IQ <70. Child subjects need to be able to contribute meaningfully to baseline and follow-up ratings, to report adverse effects, and to assent to participation. \n\n Presence of serious or unstable medical illness or psychiatric or behavioral symptoms that would make participation unsafe or study procedures too difficult to tolerate. \n\n IgA deficiency (<20mg/dL). Intravenous immunoglobulin may contain trace IgA, which may very rarely lead to life-threatening anaphylaxis in IgA-deficient participants with anti-IgA antibodies (Misbah 1993). \n\n Hyperviscosity syndromes, which can increase risks associated with IVIG administration. \n\n Need for live virus vaccine within six months after receiving IVIG (which may be 7.5 months from randomization) since IVIG can interfere with effectiveness of such vaccines. IVIG should not be administered sooner than two weeks after administration of a live virus vaccine, for the same reason. \n\n Taking nephrotoxic drugs. Every concomitant medication will be subject to scrutiny and possible consultation with pediatric safety monitors before randomization to study drug. See below as well. \n\n Recent (less than eight weeks) initiation of cognitive-behavior therapy (CBT). \n\n Recent (less than eight weeks) initiation or change in dosage of psychotropic medication for OCD or tic disorder (e.g., serotonin reuptake inhibitors for OCD, alpha-2 agonists or antipsychotics for tic disorders).", - "brief_summary": "Background:~- Some children experience a sudden onset of symptoms similar to those found in obsessive-compulsive disorder that may be caused by the body s reaction to an infection with streptococcal bacteria, most commonly seen as strep throat or scarlet fever. When the body s immune system reacts against brain cells following a streptococcal infection, the condition is known as PANDAS (pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections). The immune system response can be inactivated by treatment with a drug known as intravenous immunoglobulin (IVIG). Because there is insufficient research on IVIG s effects on the immune system of children with PANDAS, including whether IVIG is helpful in treating obsessive-compulsive symptoms related to PANDAS, researchers are interested in examining whether IVIG is an appropriate treatment for PANDAS and its associated symptoms.~Objectives:~- To test the safety and effectiveness of intravenous immunoglobulin for the treatment of obsessive-compulsive disorder in children with PANDAS (pediatric autoimmune neuropsychiatric disorder associated with streptococcal infection).~Eligibility:~- Children between 4 and 12 years of age who have obsessive-compulsive disorder (with or without a tic disorder) with sudden onset of symptoms following Group A streptococcal bacterial infections.~Design:~Participants will be screened by telephone to obtain medical history and other information, followed by in-person screening at the National Institutes of Health Clinical Center.~Participants will be admitted to the hospital to receive 2 days of infusions of either IVIG or a placebo. Frequent blood samples, imaging studies, and other tests will be performed during this visit.~Six weeks after the inpatient stay, participants will return for further blood samples and other tests. Participants who did not receive the study drug, or who received the drug but did not respond to the initial IVIG infusion, will have the option to receive IVIG at this time.~Followup visits will take place 3 months and 6 months after the first evaluation, followed by yearly follow-ups for 5 additional years.", - "NCTID": "NCT01281969" - }, - { - "brief_title": "Effects of Freeze Dried Strawberry Powder Supplementation on Vascular Function and Blood Markers of Cardiovascular Risk", - "phase": "", - "drugs": "['Low Dose Strawberry Powder', 'High Dose Strawberry Powder', 'Placebo Powder']", - "drugs_list": [ - "Low Dose Strawberry Powder", - "High Dose Strawberry Powder", - "Placebo Powder" - ], - "diseases": "['Cardiovascular Disease']", - "diseases_list": [ - "Cardiovascular Disease" - ], - "enrollment": "42.0", - "inclusion_criteria": "inclusion criteria: \n\n Men and women 35-65 years of age \n\n BMI \u2265 25 and \u2264 39 kg/m^2 \n\n LDL-C > 116 mg/dL \n\n Total Cholesterol below 273 mg/dL for men and below 284 mg/dL for women \n\n Triglycerides below 350 mg/d \n\n Non-smokers \n\n Blood pressure < 160/100 mmHg \n\n ", - "exclusion_criteria": ": \n\n History of acute or chronic inflammatory conditions or heart disease, kidney disease, liver disease, autoimmune disorders, or thyroid disease (unless controlled by medication and blood results within the previous 6 months are provided) \n\n History of diabetes mellitus (and/or a fasting glucose > 126 mg/dL at screening) \n\n Stage II hypertension (blood pressure \u2265 160/100 mmHg) \n\n Lactation, pregnancy, or desire to become pregnant during the study \n\n Unwillingness to discontinue nutritional supplements, herbs, or vitamins, unless approved by investigator \n\n Use of medications/supplements for elevated lipids, blood pressure, or glucose \n\n Chronic use of non-steroidal anti-inflammatory or immunosuppressant medication \n\n Conditions requiring the use of steroids \n\n Unwillingness to refrain from blood donation prior to and during the study \n\n Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator \n\n Allergy or sensitivity to strawberries or any ingredient in the study powders", - "brief_summary": "The purpose of this study is to evaluate the effects of freeze dried strawberry powder on LDL cholesterol, central and peripheral blood pressure, indices of arterial stiffness, and other lipid and lipoprotein concentrations. The investigators hypothesize that the bioactive compounds in freeze dried strawberry powder may elicit beneficial effects on LDL cholesterol, as well as blood pressure and arterial health.", - "NCTID": "NCT02557334" - }, - { - "brief_title": "A Prospective Study of Risperdal (Risperidone) for the Treatment of Behavioral Disorder Following Psychological Therapy for Challenging Behavior in Learning Disabled Children", - "phase": "Phase 3", - "drugs": "['risperidone']", - "drugs_list": [ - "risperidone" - ], - "diseases": "['Learning Disorders', 'Child Behavior Disorders']", - "diseases_list": [ - "Learning Disorders", - "Child Behavior Disorders" - ], - "enrollment": "19.0", - "inclusion_criteria": "inclusion criteria: \n\n DSM-IV Axis II diagnosis of mental retardation \n\n behavioural and family therapy tried for 6 months but has failed \n\n in school, at least part time \n\n score of >=8 on hostility scale \n\n subject is otherwise healthy \n\n ", - "exclusion_criteria": ": \n\n Patients with a seizure disorder requiring repeated change of medication \n\n extrapyramidal symptoms not well controlled by medication \n\n abnormal and clinically significant electrocardiogram (ECG) changes \n\n history of tardive dyskinesia (a condition of uncontrollable movements of the tongue, lips, face, trunk, hands and feet that is seen in patients receiving long-term medication with certain types of antipsychotic drugs), or neuroleptic malignant syndrome (a rare condition in patients receiving antipsychotic medication in which patients may develop fever, sweating, unstable blood pressure, rigid muscles, and other symptoms, including changes in their normal mental state) \n\n known hypersensitivity to antipsychotic medications, including risperidone.", - "brief_summary": "The purpose of this study is to assess whether risperidone (an antipsychotic medication) is safe and effective in treating behaviour disorder in learning disabled children, which does not improve with psychological therapy.", - "NCTID": "NCT00254930" - }, - { - "brief_title": "Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Perennial Allergic Rhinitis (PAR)", - "phase": "Phase 2; Phase 3", - "drugs": "['fexofenadine/Allegra (M016455)']", - "drugs_list": [ - "fexofenadine/Allegra (M016455)" - ], - "diseases": "['Rhinitis Perennial']", - "diseases_list": [ - "Rhinitis Perennial" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged 6 months through 11 years \n\n Patients with perennial allergic rhinitis \n\n ", - "exclusion_criteria": ": \n\n Neither serum specific IgE antibody or skin reaction is positive for the antigen of perennial allergy. \n\n Nasal symptom score is 0 for either sneezing or nasal discharge, or sum of these two score is less than 3, or nasal congestion score is 4. \n\n Patients with vasomotor rhinitis or eosinophilic rhinitis. \n\n The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.", - "brief_summary": "Primary Objective:~- To evaluate safety (4 weeks)~Secondary Objectives:~To evaluate the long-term safety (12 weeks)~To evaluate the efficacy~To characterize the pharmacokinetic profile", - "NCTID": "NCT01244217" - }, - { - "brief_title": "Management of Drug Hypersensitivity in Children", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Drug Hypersensitivity']", - "diseases_list": [ - "Drug Hypersensitivity" - ], - "enrollment": "250.0", - "inclusion_criteria": "inclusion criteria: \n\n Participation will be proposed to any children (0 to 16 years) receiving one or several drug(s) and developing one of the following clinical manifestations: urticaria, maculopapular rash, bullous eruption, flush, anaphylaxis, serum sickness-like disease, SJS, TEN, DRESS or fever linked to drug intake. \n\n ", - "exclusion_criteria": ": \n\n Patients will be excluded if the symptoms occur more than 72 hours after any treatment was stopped or if the symptoms are clearly linked to another cause (measles, rubeola, roseola, varicella, fifth disease, Gianotti-Crosti syndrome, scarlet fever, Gibert's pityriasis or food allergy).", - "brief_summary": "The aim of this study is (1) to assess the incidence of suspected drug allergies in a pediatric hospital and the proportion in which these reactions are confirmed to be allergic; (2) to evaluate the diagnostic values of the different allergy tests available; (3) to investigate the pathophysiology of drug allergies, particularly by investigating the role of viruses, and by performing HLA typing and a gene expression profile both in the acute phase of the reaction and 2 months later.", - "NCTID": "NCT02031120" - }, - { - "brief_title": "Impact of Antibiotic Treatment of Group A Streptococcal Blistering Distal Dactylitis in Children", - "phase": "", - "drugs": "['Positive rapid GAS test', 'Negative rapid GAS test']", - "drugs_list": [ - "Positive rapid GAS test", - "Negative rapid GAS test" - ], - "diseases": "['Blistering Distal Dactylitis']", - "diseases_list": [ - "Blistering Distal Dactylitis" - ], - "enrollment": "177.0", - "inclusion_criteria": "inclusion criteria: \n\n Children 0-18 years \n\n Distal blistering dactylitis collected or not collected \n\n Positive rapid Group A Streptococcus test \n\n Informed consent signed by the parents \n\n ", - "exclusion_criteria": ": \n\n Subungual or pulp Whitlow \n\n Children not affiliated to the social security scheme \n\n Refusal by the parents to participate in the study", - "brief_summary": "Single-center prospective study to assess the clinical course of group A streptococcal blistering distal dactylitis in children after antibiotic treatment.", - "NCTID": "NCT02624882" - }, - { - "brief_title": "Sofia Strep A FIA Field Study", - "phase": "", - "drugs": "['In Vitro Diagnositc aid for diagnosis']", - "drugs_list": [ - "In Vitro Diagnositc aid for diagnosis" - ], - "diseases": "['Group A Streptococcus', 'Strep Throat']", - "diseases_list": [ - "Group A Streptococcus", - "Strep Throat" - ], - "enrollment": "2090.0", - "inclusion_criteria": "inclusion criteria: \n\n Presence of sore throat \n\n Redness of the posterior pharyngeal wall \n\n Tonsillar exudate \n\n Tonsillar swelling \n\n Tender anterior cervical adenopathy \n\n Fever, > 38\u00ba C (100.4\u00baF) at presentation or within past 24 hours \n\n Other symptoms that may be present, in addition to above symptoms for GAS: \n\n Rash, typical of scarlet fever \n\n Abnormal tympanic membranes \n\n Palatal petechiae \n\n ", - "exclusion_criteria": ": \n\n Subjects treated with antibiotics currently or within the previous week (7 days) are not to be included in this study. \n\n At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.", - "brief_summary": "The purpose of this study is to demonstrate the ability of the Sofia Strep A FIA test and Sofia Analyzer to accurately detect a throat swab specimen for the presence or absence of Group A Streptococcus when compared to culture.", - "NCTID": "NCT01494792" - }, - { - "brief_title": "The Effect of Omalizumab on Responses to Cat Allergen Challenge", - "phase": "", - "drugs": "['omalizumab', 'placebo']", - "drugs_list": [ - "omalizumab", - "placebo" - ], - "diseases": "['Allergic Rhinitis']", - "diseases_list": [ - "Allergic Rhinitis" - ], - "enrollment": "18.0", - "inclusion_criteria": "inclusion criteria: \n\n Ability to understand and provide informed consent \n\n Male or Female (non-pregnant), age 18-50 \n\n Females must be: Surgically sterile (hysterectomy, bilateral oophorectomy, bilateral tubal ligation), OR postmenopausal (at least 1 year since last menses), OR using a medically acceptable form of birth control throughout the duration of the study. \n\n Clinical history of seasonal or perennial allergic rhinitis for at least two years, with or without mild persistent asthma \n\n Positive puncture skin test greater than or equal to 5 mm diluent control \n\n Positive Immunocap to Fel d 1 > 0.35 kallikrein unit/L \n\n Positive intranasal cat allergen challenge as defined by > 5 sneezes or a tripling of measured nasal lavage mediators \n\n In vitro assay of basophil responsiveness to cat allergen with greater than 20% histamine release \n\n The use of antihistamines, cromolyn, leukotriene modifiers and other non-steroid (astelin and topical decongestants), nasal medications will be allowed, but they will be withheld for 5 days prior to each nasal allergen provocation session. Inhaled corticosteroids for mild asthma will be permissible. \n\n No known contraindications to therapy with omalizumab \n\n ", - "exclusion_criteria": ": \n\n Asthma with forced expiratory volume at one second (FEV1) < 80%, moderate to severe asthma classification per National Asthma Education and Prevention Program Expert Panel (NAEP) Standards (1997 National Asthma Education and Prevention Program Expert Panel Report II guidelines) \n\n Serum IgE levels less than 30 IU/mL or greater than 700 IU/mL at the time of enrollment will be excluded \n\n Unexplained elevation of erythrocyte sedimentation rate (ESR), hematocrit < 32%, white blood cell (WBC) count 2400/microliter lower limit of normal, platelet < 75000/microliter, creatinine > 141.4 micromolar/L, or aspartate aminotransferase (AST) > 100 IU/L \n\n Body weight less than 30 kg or greater than 150 kg will be excluded. \n\n Plans to become pregnant or breastfeed will be excluded from the study \n\n A perforated nasal septum, structural nasal defect, large nasal polyps causing obstruction, evidence of acute or chronic sinusitis \n\n A life expectancy less than 6 months \n\n A terminal illness as determined by the investigator \n\n A history of malignancy, anaphylaxis or bleeding disorder are also exclusion illnesses. \n\n Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements. \n\n Inability or unwillingness of a participant to give written informed consent or comply with study protocol \n\n Use of any investigational drugs within 8 weeks of participation \n\n Contraindications to omalizumab include patients with a previous hypersensitivity to omalizumab \n\n Recent recipient of any licensed or investigational live attenuated vaccine(s) within two months of study initiation such as flu mist. \n\n Prior use of omalizumab \n\n Frequent sinusitis (>2/ documented episodes per year) or active sinusitis within 2 weeks of enrollment \n\n Use of immunotherapy within the last 5 years", - "brief_summary": "This research is being done to study the effects of the drug omalizumab (Xolair) in people with cat allergies. The investigators will use omalizumab to study changes in the cells in the nose, skin and blood that cause allergies. The investigators predict that cells in the blood will be effected before cells in the nose or skin.", - "NCTID": "NCT00604786" - }, - { - "brief_title": "Characterization of Childhood-Onset Obsessive-Compulsive Disorder", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Obsessive-Compulsive Disorder']", - "diseases_list": [ - "Obsessive-Compulsive Disorder" - ], - "enrollment": "49.0", - "inclusion_criteria": "inclusion criteria: \n\n OCD Participants (N = 72) \n\n Aged 4-12 years and living within a four-hour commute from NIH \n\n Currently meet DSM-IV criteria for OCD. \n\n Recent onset of symptoms (less than 6 months.) \n\n Healthy Controls (N = 60-72) \n\n Age and sex matched to ODC participants. \n\n Must be free of current or past psychopathology. \n\n ", - "exclusion_criteria": ": \n\n OCD Participants: \n\n Diagnosis of schizophrenia, schizoaffective, bipolar, delusional, or psychotic disorder; autistic spectrum disorder or pervasive developmental disorder; neurologic disorder other than tics; or rheumatic fever. \n\n Significant or unstable medical illness. \n\n Full scale IQ less than 80. \n\n Healthy Controls: \n\n Full scale IQ less than 80. \n\n Significant or unstable medical illness.", - "brief_summary": "The purpose of this study is to learn more about Obsessive-compulsive Disorder (OCD) in children. OCD usually has a slow onset, and symptoms that may remain at a stable level over time. A subset of children with OCD has a sudden onset and symptoms that fluctuate in severity over time. This study will also compare healthy children to those with OCD. This is an observational study; children who participate will not receive any new or experimental therapies.~OCD affects nearly 1% of the pediatric population. The symptoms of this illness can interrupt development, causing significant psychological distress and producing life-long impairments in social, academic, and occupational functioning. A subgroup of pediatric OCD has been designated by the acronym PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections). This type of OCD is characterized by sudden symptom onset and a relapsing-remitting course of illness; exacerbation of symptoms occurs with scarlet fever or strep. throat infections. This study will identify factors that distinguish children with PANDAS OCD from children with non-PANDAS OCD, and will compare both groups to healthy children.~Children with OCD and their parents are screened with interviews and a review of the child's medical records. Participants have an initial evaluation that includes a psychiatric, physical and neuromotor exam, neuropsychological testing, psychological interviews, and a blood test. Structural magnetic resonance imaging (MRS) scans of the brain are also obtained. The MRS scan does not use radiation.~After the initial evaluation, children with OCD have follow-up visits every 6 weeks for 12 to 24 months. They are seen yearly for 8 years after the study. If they have a significant improvement or worsening of their symptoms, they are asked to make a maximum of two extra visits. Parents of OCD patients are called four times a year to discuss any changes in the child's condition between yearly visits. All participants have a 1-year follow-up visit upon study completion.", - "NCTID": "NCT00044239" - }, - { - "brief_title": "Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion", - "phase": "Phase 3", - "drugs": "['Arterial line', 'Motion']", - "drugs_list": [ - "Arterial line", - "Motion" - ], - "diseases": "['Healthy', 'Hypoxia']", - "diseases_list": [ - "Healthy", - "Hypoxia" - ], - "enrollment": "18.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female of any race \n\n 18-50 years old, inclusive \n\n Females: negative urine pregnancy test on the day of study participation (prior to exposure to hypoxia) \n\n Completed within the last year: physical exam by a licensed physician, physician assistant (PA), or advanced practice nurse; including a 12 lead ECG, a medical history, and blood test (complete blood count and sickle cell trait/disease screening) \n\n Meets specific demographic requirements for the monitoring device under study \n\n Willing and able to provide written informed consent \n\n Able to participate for the duration of the evaluation \n\n ", - "exclusion_criteria": ": \n\n A room-air baseline % modulation < 1.5% on all four fingers on the test hand \n\n Under 18 years or over 50 years of age \n\n Pregnant and/or lactating women \n\n Hypertension: on three consecutive readings, systolic pressure greater than 145 mm Hg or diastolic pressure greater than 90 mm Hg \n\n Ventricular premature complexes (VPC's) that are symptomatic or occur at a rate of more than four per minute \n\n History of seizures (except childhood febrile seizures) or epilepsy \n\n History of unexplained syncope \n\n Daily or more frequent use of anxiolytic drugs (benzodiazepines) for treatment of anxiety disorder \n\n Recent history of frequent migraine headaches: average of two or more per month over the last year \n\n Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.) \n\n History of acute altitude sickness at or below moderate elevation (up to 5,000-10,000 feet) defined as three or more of the following symptoms: moderate to severe headache, general malaise, dizziness/lightheadedness, nausea/vomiting, fatigue/weakness, shortness of breath, nosebleed, persistent rapid pulse, or peripheral edema \n\n History of significant respiratory disease such as severe asthma or emphysema or sleep apnea \n\n Sickle cell disease or trait \n\n Clinically significant abnormal finding on medical history, physical examination, clinical laboratory test or ECG. Clinical significance will be assessed by the principal investigator or study physician as designated. \n\n History of stroke, transient ischemic attack or carotid artery disease \n\n History of myocardial ischemia, angina, myocardial infarction, congestive heart failure or cardiomyopathy \n\n History of chronic renal impairment \n\n Severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors \n\n Unwillingness or inability to remove colored nail polish or artificial nails from test digit(s) \n\n Unwillingness or inability to give informed consent \n\n Prior or known allergies to: lidocaine (or similar pharmacological agents, e.g., Novocain) or heparin \n\n Recent arterial cannulation (i.e., less than 30 days prior to study date) \n\n Six or more arterial cannulations of each (right & left) radial artery \n\n History of clinically significant complications from previous arterial cannulation \n\n Current use of blood thinners: prescription or daily aspirin use \n\n History of bleeding disorders or personal history of prolonged bleeding from injury.", - "brief_summary": "To validate the proposed claims for pulse rate and saturation accuracy in a diverse subject population during motion over a specified saturation range.", - "NCTID": "NCT02247765" - } - ], - "1": [ - { - "brief_title": "Doxycycline Treatment to Prevent Progressive Coronary Artery Dilation in Children With Kawasaki Disease", - "phase": "Phase 2", - "drugs": "['Doxycycline', 'Placebo']", - "drugs_list": [ - "Doxycycline", - "Placebo" - ], - "diseases": "['Kawasaki Disease', 'Coronary Aneurysm']", - "diseases_list": [ - "Kawasaki Disease", - "Coronary Aneurysm" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Treatment arm: Patients aged 1 month to 21 years with confirmed KD will be included in the study if they meet the following criteria: \n\n Patients with dilation of the right or left anterior descending coronary artery beyond a z-score of +2.5 during the acute febrile phase of KD. \n\n Patients with aneurysms of the right or left main coronary arteries during the acute febrile phase of KD. \n\n Patients with refractory KD after initial treatment with IVIG and dilated coronary arteries on an echocardiogram during the first month of KD. \n\n Comparison arm: Patients aged 1 month to 18 years with confirmed KD, who do not meet inclusion criteria to be included in the treatment group. \n\n 1.Patients with right or left anterior descending coronary artery measurements below a z-score of +2.5 during the acute febrile phase of KD. \n\n ", - "exclusion_criteria": ": \n\n The following patients will be excluded from this study: \n\n Patients with clinically incomplete KD. \n\n Patients whose parents refuse to administer doxycycline. \n\n Patients with acute renal failure. \n\n Patients with chronic liver and kidney disease.", - "brief_summary": "Kawasaki disease (KD) affects infants and young children causing inflammation of the skin and blood vessels including the coronary arteries of the heart. Despite the currently available therapy, about one third of children develop enlargement of the coronary arteries that can lead to serious complications such as coronary artery stenosis, heart attack and even death.~Kawasaki disease is the most common heart disease in children in the USA and it is especially common among the children of Hawaii. Every year, 50-90 children are diagnosed with KD in Hawaii and unfortunately there is no medication available to successfully prevent coronary artery damage in a subset of cases.~During the first few weeks of the illness, cells of the immune system attack the coronary arteries and release a special substance (MMP) that is responsible for the coronary artery enlargement. There is a common antibiotic, doxycycline that can specifically block the action of this special substance (MMP). Research done on animals with KD showed that doxycycline was able to block this special substance and prevent enlargement of coronary arteries. Research in adults with enlargement of the main artery in their abdomen also showed that doxycycline may improve the outcome. Based on these studies doxycycline may be a promising therapy for children with KD, who develop enlargement of the coronary arteries.~The investigators' proposed research study will assess the usefulness of doxycycline in preventing the progressive enlargement of coronary arteries in children with KD. The investigators plan to perform a small (pilot) study to evaluate how good is doxycycline in preventing coronary artery enlargement. The investigators will treat 50 children with KD and enlarged coronary arteries for three weeks with doxycycline and assess the change in coronary arteries as well as the blood levels of the special substance (MMP). If doxycycline proves to be beneficial in this small study, the investigators are going to design a large research study involving multiple institutions on Hawaii and the mainland and will recruit more children to be certain about the value of the proposed treatment. The investigators' proposal may change the treatment protocol of KD and could present a possible treatment for children with enlarged coronary arteries preventing potentially devastating consequences.", - "NCTID": "NCT01917721" - }, - { - "brief_title": "Anakinra and Kawasaki Disease", - "phase": "Phase 2", - "drugs": "['Anakinra']", - "drugs_list": [ - "Anakinra" - ], - "diseases": "['Kawasaki Disease', 'Children']", - "diseases_list": [ - "Kawasaki Disease", - "Children" - ], - "enrollment": "16.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients, male and female, at any age \u2265 3 months (5 kg) of life, with KD according to the American Heart Association definition for complete or incomplete KD. fever \u2265 5 days and \u2265 4 of 5 main clinical signs: modification of the extremities, polymorphic exanthema, bilateral bulbar not exudative conjunctivitis, erythema of the lips or oral cavity, and cervical lymph nodes usually unilateral > 1.5 cm in diameter. In the presence of less than 4 clinical criteria and 5 days of fever, the diagnosis of disease KD is proposed in case of coronary abnormalities (at least one dilated coronary artery with internal diameter \u2265 2,5 SD from the mean normalized for body surface area (Z score) as determined by echocardiography. For indicative purpose, in case of incomplete KD, other biological supportive criteria for incomplete KD can help to ensure the diagnosis: leucocytosis, elevated CRP, elevated ESR, anaemia, hyponatremia, elevated ASAT, ALAT and gGT, hyperlipidaemia. \n\n Patients who failed to respond to standard therapy of KD:, e.g. Persistence or recrudescence of fever \u2265 38\u00b0C, 48 hours after the infusion of 2g/kg of IV Ig, \n\n Weight \u22655Kg \n\n Patient, parent or legal guardian's written informed consent is required \n\n Patient with health insurance \n\n Patient agrees to have effective contraception for the duration of participation in the research \n\n ", - "exclusion_criteria": ": \n\n Preterm and neonates, pregnancy \n\n Patients suspected with another diagnosis \n\n Patients with overt concomitant bacterial infection \n\n Patients previously treated with another biotherapy \n\n Patients with any type of immunodeficiency or cancer \n\n Patients with increased risk of TB infection \n\n Recent tuberculosis infection or with active TB \n\n Close contact with a patient with TB \n\n Patients recently arrived less than 3 months from a country with high prevalence of TB \n\n A chest radiograph suggestive of TB \n\n Patients with end stage renal disease: NKF stages \u22654; eGFR\u226429mL/min/1.73 m2 or diabetes mellitus or neutropenia <1500/mm3 or liver failure \n\n Hypersensitivity to the active substance or to any of the excipients (citric acid and anhydrous; sodium chloride disodium edetate dehydrate polysorbate 80; sodium hydroxide; water for injections) \n\n Patient already included in a biomedical research other than observational (e.g.; cohort, registry)", - "brief_summary": "The study is designed to assess the efficacy and safety of anakinra, an interleukin 1 receptor antagonist, in patients with Kawasaki disease who failed to respond to standard treatment:e.g. one infusion of 2g/kg of intravenous immunoglobulins.", - "NCTID": "NCT02390596" - } - ], - "2": [ - { - "brief_title": "Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Kawasaki Disease']", - "diseases_list": [ - "Kawasaki Disease" - ], - "enrollment": "2402.0", - "inclusion_criteria": "inclusion criteria: \n\n The 5th revised edition of diagnostic criteria for KD, issued by the Japan Kawasaki Disease Research Committee at the 7th International Kawasaki Disease Symposium in 2002, was adopted. Cases were included in the study if the patients had at least five of the following six clinical manifestations or at least four signs together with coronary abnormalities documented by echocardiography or coronary angiography: \n\n fever persisting 5 days or longer (inclusive of those cases in whom the fever has subsided before the 5th day in response to therapy) \n\n bilateral conjunctival congestion \n\n changes of lips and oral cavity, such as reddening of lips, strawberry tongue, diffuse congestion of oral and pharyngeal mucosa \n\n polymorphous exanthema \n\n changes of peripheral extremities, such as reddening of palms and soles, indurative edema at initial stage, or membranous desquamation from fingertips at convalescent stage \n\n acute nonpurulent cervical lymphadenopathy. In addition, the cases of incomplete KD, diagnosed with referring to the guidelines for incomplete KD made by American Academy of Pediatrics (AAP) and American Heart Association (AHA) in 2004, were also included in this investigation \n\n ", - "exclusion_criteria": ": \n\n The cases were not in accordance with the recruited criteria", - "brief_summary": "To investigate the epidemiological pictures of Kawasaki disease (KD) in Shanghai from 2008 through 2012, and illustrate the risk factors of coronary arterial lesions .", - "NCTID": "NCT02317913" - }, - { - "brief_title": "Different Doses of IVIG for Kawasaki Disease", - "phase": "Phase 3", - "drugs": "['IVIG (1g/kg,once)', 'IVIG (1g/kg,twice)', 'IVIG (2g/kg.once)']", - "drugs_list": [ - "IVIG (1g/kg,once)", - "IVIG (1g/kg,twice)", - "IVIG (2g/kg.once)" - ], - "diseases": "['Kawasaki Disease']", - "diseases_list": [ - "Kawasaki Disease" - ], - "enrollment": "404.0", - "inclusion_criteria": "inclusion criteria: \n\n Individual patient's medical file data confirmed the diagnosis of KD using the 5th revised edition of diagnostic criteria for KD, issued by the Japan Kawasaki Disease Research Committee at the 7th International Kawasaki Disease Symposium in 2002. \n\n the patients aged from 1 months to 12 years old. \n\n All included patients required to sign an informed consent form. \n\n the patients didn't receive treatment before. \n\n ", - "exclusion_criteria": ": \n\n The patients with the application of hormone or other immunosuppressive agents; \n\n The patients didn't want to signed informed consent.", - "brief_summary": "The objective of this study is to investigate the effect of different doses of intravenous immunoglobulin (IVIG) (1g/kg once, 1g/kg twice, 2g/kg once) for Kawasaki disease (KD) in a multicentre, prospective,randomised trial.", - "NCTID": "NCT02439996" - }, - { - "brief_title": "Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease", - "phase": "Phase 3", - "drugs": "['TA-650', 'Polyethylene Glycol-treated Human Immunoglobulin (VGIH)']", - "drugs_list": [ - "TA-650", - "Polyethylene Glycol-treated Human Immunoglobulin (VGIH)" - ], - "diseases": "['Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin']", - "diseases_list": [ - "Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin" - ], - "enrollment": "31.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients diagnosed with Kawasaki disease (incipient cases only) with 5 or more of the 6 major symptoms of Kawasaki disease. \n\n Patients refractory to initial IVIG therapy (a single administration at 2 g per kg body weight). \n\n Patients with a fever of 37.5\u00baC or higher axillary temperature at the time of enrollment. \n\n Patients to whom the study drug can be administered by day 8 of disease. \n\n ", - "exclusion_criteria": ": \n\n Patients who have received vaccination with Bacille Calmette-Gu\u00e9rin (BCG) vaccine within 6 months before the enrollment. \n\n Patients with a complication, or a history within 6 months before the enrollment of, serious infections requiring hospitalization. \n\n Patients with a complication, or a history within 6 months before the enrollment of, opportunistic infections. \n\n Patients complicated with active tuberculosis, active hepatitis B or C, or patients confirmed to be hepatitis B virus carriers or a history of hepatitis B. \n\n Patients confirmed to have HIV infection, or patients with a family history of HIV infection. \n\n Patients who have a history of receiving treatment with infliximab or other biological products. \n\n Patients who had participated in another clinical study and had received a study drug within 12 weeks before giving consent.", - "brief_summary": "The purpose of this study is to evaluate the efficacy and safety of TA-650 in comparison with a control drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in patients with Kawasaki disease refractory to initial therapy with Intravenous Immunoglobulin (IVIG). The pharmacokinetics of TA-650 is also examined.", - "NCTID": "NCT01596335" - }, - { - "brief_title": "Infliximab (Remicade) for Patients With Acute Kawasaki Disease", - "phase": "Phase 1", - "drugs": "['Infliximab (Remicade)', 'Intravenous immunoglobulin (IVIG)']", - "drugs_list": [ - "Infliximab (Remicade)", - "Intravenous immunoglobulin (IVIG)" - ], - "diseases": "['Kawasaki Disease']", - "diseases_list": [ - "Kawasaki Disease" - ], - "enrollment": "24.0", - "inclusion_criteria": "inclusion criteria \n\n To be eligible for the trial, subjects must meet all of the following criteria: \n\n All eligible subjects, or legal representative, must provide written informed consent/assent, prior to initiation of any study procedure. \n\n Eligible subjects will be infants and children, under 18 years old, with acute KD who remain or become febrile (>/= 38.3\u02da C or 101.0\u02da F) after the end of the 48 h-period after completing their IVIG infusion (2gm/kg). \n\n Patients must have persistent or reoccurrence of fever > 48 hours of observation to be eligible for the trial. \n\n Prior to the initial IVIG treatment, patients must have been febrile for >/= 3 days and have met 4/5 standard clinical criteria (Table 1) - OR - patients with fever and 3/5 clinical criteria will be eligible if echocardiogram demonstrates at least one coronary artery segment with a Z score of > 2. \n\n Patients must present for their initial diagnosis and IVIG treatment within the first 14 days after fever onset (Illness Day 14). \n\n Females of childbearing potential and males must be using adequate contraception (abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) throughout the trial. \n\n All eligible subjects must have a chest radiograph within one week prior to first infusion of study drug with no evidence of malignancy, infection or fibrosis. \n\n ", - "exclusion_criteria": " \n\n If a subject has any of the following criteria, he or she may not be enrolled in the study: \n\n Have been receiving corticosteroids (ie, via any route) at doses > 1 mg/kg prednisone equivalent daily. \n\n Have history of TB or TB exposure. \n\n Have history of histoplasmosis or coccidiomycosis. \n\n Have received anakinra (Kineret\u00ae), etanercept (Enbrel\u00ae), or adalimumab (Humira\u00ae) within 1 month prior to first study drug administration. \n\n Have any chronic disease, except asthma, atopic dermatitis or controlled seizure disorder. \n\n Have documented history of current active hepatitis B or a history of hepatitis C infection. \n\n Have documented history of human immunodeficiency virus (HIV) infection \n\n Have received a transplanted organ (with the exception of a corneal transplant performed > 3 months prior to first study drug administration). \n\n Have a known malignancy or history of malignancy within the 5-year period prior to first study drug administration (with the exception of squamous or basal cell carcinoma of the skin that has been completely excised without evidence of recurrence). \n\n Have a history of prior lymphoproliferative disease including lymphoma. \n\n Have multiple sclerosis or other central demyelinating disorder. \n\n Have received any previous treatment with infliximab or other monoclonal antibodies. \n\n Have used any investigational drug within 1 month prior to first study drug administration or within 5 half-lives of the investigational agent, whichever is longer. \n\n Are participating in another investigative trial, involving investigational agents, during participation in this trial. \n\n Have a history of substance abuse (drug or alcohol) within the previous 3 years. \n\n Are pregnant, nursing, or planning pregnancy (both men and women) during the trial or within the 6-month period thereafter. \n\n Have a known allergy to murine proteins or other chimeric proteins. \n\n Patients with ischemic congestive heart failure.", - "brief_summary": "This study evaluates the safety of infliximab in infants and children with acute Kawasaki Disease.", - "NCTID": "NCT00271570" - }, - { - "brief_title": "Etanercept in Kawasaki Disease", - "phase": "Phase 2", - "drugs": "['Etanercept', 'Placebo']", - "drugs_list": [ - "Etanercept", - "Placebo" - ], - "diseases": "['Mucocutaneous Lymph Node Syndrome', 'Kawasaki Disease']", - "diseases_list": [ - "Mucocutaneous Lymph Node Syndrome", - "Kawasaki Disease" - ], - "enrollment": "196.0", - "inclusion_criteria": "inclusion criteria: \n\n Male Age 2 months to 20 years of age Female Age 2 months to 11 years of age \n\n Provision of Parental Consent \n\n Kawasaki Disease Presentation \n\n ", - "exclusion_criteria": ": \n\n Laboratory Criteria: Any laboratory toxicity, at the time of the screening visit or at any time during the study that in the opinion of the Investigator would preclude participation in the study or: \n\n Platelet count < 100,000/mm3 \n\n WBC count < 3,000 cells/mm3 \n\n Hemoglobin, hematocrit, or red blood cell count outside 30% of the upper or lower limits of normal for the Lab \n\n Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit. \n\n Female subjects diagnosed with KD 12 years of age and older. \n\n Subjects who have known hypersensitivity to Enbrel or any of its components or who is known to have antibodies to etanercept \n\n Prior or concurrent cyclophosphamide therapy \n\n Prior treatment with any TNF alpha antagonist or steroid within 48 hours prior to initiation of IVIG \n\n Concurrent sulfasalazine therapy \n\n Active severe infections within 4 weeks before screening visit, or between the screening and baseline visits. \n\n SLE, history of multiple sclerosis, transverse myelitis, optic neuritis, or chronic seizure disorder \n\n Known HIV-positive status or known history of any other immuno-suppressing disease. \n\n Any mycobacterial disease or high risk factors for tuberculosis, such as family member with TB or taking INH \n\n Untreated Lyme disease \n\n Severe comorbidities (diabetes mellitus requiring insulin, CHF of any severity, MI, CVA or TIA within 3 months of screening visit, unstable angina pectoris, uncontrolled hypertension (sitting systolic BP > 160 or diastolic BP > 100 mm Hg), oxygen-dependent severe pulmonary disease, history of cancer within 5 years [other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer]) \n\n Exposure to hepatitis B or hepatitis C or high risk factors such as intravenous drug abuse in patient's mother, or history of jaundice (other than neonatal jaundice). SLE, history of multiple sclerosis, transverse myelitis, optic neuritis or chronic seizure disorder. \n\n Use of a live vaccine (Measles Mumps Rubella or Varicella) 30 days prior to or during this study. \n\n Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient \n\n History of non-compliance with other therapies \n\n Must not have received immunosuppressive agents for at least three months prior to enrollment.", - "brief_summary": "The purpose of this study is to determine whether Etanercept (Enbrel) when used in conjunction with IVIG and aspirin, improves treatment response to IVIG in patients with Kawasaki Disease. Funding Source- FDA/OOPD", - "NCTID": "NCT00841789" - } - ] - }, - { - "patient_id": "sigir-20145", - "patient": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", - "0": [ - { - "brief_title": "Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer", - "phase": "", - "drugs": "['LEFt clinical decision rule']", - "drugs_list": [ - "LEFt clinical decision rule" - ], - "diseases": "['Pregnancy', 'Deep Vein Thrombosis']", - "diseases_list": [ - "Pregnancy", - "Deep Vein Thrombosis" - ], - "enrollment": "366.0", - "inclusion_criteria": "inclusion criteria: \n\n Unselected pregnant women (as self-reported by patient and/or previously documented positive beta hCG on urine or serum pregnancy tests) with \n\n Suspected acute symptomatic deep vein thrombosis, defined as: \n\n New leg swelling or edema with onset in the last month or, \n\n New leg pain (buttock, groin, thigh or calf) with onset in the last month. \n\n ", - "exclusion_criteria": ": \n\n Below the age of legal consent in jurisdiction of residence (18 years old for Quebec and 16 years old for rest of Canada) \n\n Baseline imaging (imaging done after a minimum of 3 months of treatment for prior proximal DVT) not available if suspected recurrence in the same leg as prior \n\n Unable or unwilling to provide informed consent \n\n Concomitant symptoms of suspected pulmonary embolism (chest pain or shortness of breath or syncope/pre-syncope or unexplained tachycardia) \n\n Therapeutic anticoagulant more than 48 hours.", - "brief_summary": "This is prospective cohort study in pregnant women who present with signs and symptoms of possible deep vein thrombosis (DVT). All patients will have the same method of assessment of their DVT symptoms (the LEFt clinical decision rule will be applied and D-dimer test will be done) to determine if a compression ultrasound is required. All patients will be followed for a period of 3 months.", - "NCTID": "NCT02507180" - }, - { - "brief_title": "Compression Treatment Effects on Complications and Healing of Achilles Tendon Rupture", - "phase": "", - "drugs": "['Intermittent pneumatic compression (IPC)']", - "drugs_list": [ - "Intermittent pneumatic compression (IPC)" - ], - "diseases": "['Rupture', 'Venous Thromboembolism', 'Venous Thrombosis', 'Surgical Wound Infection']", - "diseases_list": [ - "Rupture", - "Venous Thromboembolism", - "Venous Thrombosis", - "Surgical Wound Infection" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Achilles tendon rupture operated on within 96 hours of diagnose. \n\n ", - "exclusion_criteria": ": \n\n Inability or refusal to give informed consent for participation in the study \n\n Ongoing treatment with anticoagulant therapy \n\n Inability to comply with the study instructions \n\n Known kidney disorder \n\n Heart failure with pitting oedema \n\n Thrombophlebitis \n\n Recent thromboembolic event (during the preceding 3 months) \n\n Recent surgery (during the preceding month) \n\n Presence of known malignancy \n\n Current bleeding disorder \n\n Pregnancy", - "brief_summary": "This prospective randomized study aims to determine whether intermittent pneumatic compression (IPC), 75 patients, beneath functional bracing compared to treatment-as-usual in plaster cast, 75 patients, can reduce the Venous Thromboembolism (VTE) incidence and promote healing of sutured acute Achilles tendon ruptures.~At two weeks post surgery, the IPC intervention will be ended and both patient groups will be immobilized in an orthosis until follow-up at six weeks.~The endpoint of the first part of the study is VTE events. The primary outcome will be the DVT-incidence at two weeks, assessed using screening compression duplex ultrasound (CDU) by two ultrasonographers masked to the treatment allocation. Secondary outcome will be the DVT-incidence at 6 weeks.~1) Deep Vein Thrombosis (DVT) detected by CDU , 2) isolated calf muscle vein thrombosis (ICMVT) detected by CDU, 3) symptomatic DVT or ICMVT detected by CDU, 4) symptomatic pulmonary embolism detected by computer tomography.~The endpoint of the second part of the study is tendon healing quantified at 2 weeks by microdialysis followed by quantification of markers for tendon repair.~The endpoint of the third part of the study is the functional outcome of the patients at one year post-operatively using four reliable and valid scores, i.e. the Achilles tendon Total Rupture Score (ATRS), Physical Activity scale (PAS), Foot and Ankle Outcome Score (FAOS) and EuroQol Group's questionnaire (EQ-5D) as well as the validated heel-rise test.", - "NCTID": "NCT01317160" - }, - { - "brief_title": "Natural History of Isolated Deep Vein Thrombosis of the Calf", - "phase": "", - "drugs": "['Ultrasound examination of leg veins']", - "drugs_list": [ - "Ultrasound examination of leg veins" - ], - "diseases": "['Isolated Distal DVT', 'Proximal DVT', 'Pulmonary Embolism']", - "diseases_list": [ - "Isolated Distal DVT", - "Proximal DVT", - "Pulmonary Embolism" - ], - "enrollment": "500.0", - "inclusion_criteria": "inclusion criteria: \n\n suspected deep vein thrombosis of a leg \n\n intermediate/high pre-test clinical probability or high D-dimer levels \n\n ", - "exclusion_criteria": ": \n\n age < 18 years \n\n presence of proximal DVT \n\n suspected isolated iliac DVT \n\n symptoms/signs lasting from > 30 days \n\n presence of symptoms of pulmonary embolism \n\n pregnancy or puerperium \n\n full dose treatment with heparin or derivatives from > 1 day \n\n presence of superficial vein thrombosis \n\n limited life expectancy (< 6 months) \n\n geographically inaccessible location \n\n inability or refusal to give consent \n\n participation in other clinical studies", - "brief_summary": "Whether isolated distal DVT (IDDVT), DVT confined to the calf, should be looked for and diagnosed to allow them to be treated with anticoagulants remains one of the still unsolved issues in vascular medicine, especially because of the insufficient data on clinical risks of untreated distal DVT. Management studies have shown that it is safe to withhold anticoagulation in outpatients with suspected DVT if compression ultrasonography (CUS) limited to the proximal deep veins yields normal results on presentation and on repeated examination after 5 to 7 days. This strategy is based on the premise that IDDVT do not need to be diagnosed and treated, what is necessary when they extend involving the proximal veins. There is no general agreement, however, on the assumption that the non-extending IDDVT do not need to be diagnosed and treated, and many authors recommend to perform a single CUS examination extended to the distal deep veins. All the available studies have treated with anticoagulants the diagnosed IDDVT and no adequate information is available on the risk of IDDVT left untreated.~The present study, performed in outpatients with suspected leg DVT, aims at assessing the clinical consequences of IDDVT diagnosed (by a complete US investigation) but not treated because the results of this investigation remain blind to both the patient and the treating doctor, whereas the diagnostic-therapeutic procedure remains the usual one, based on CUS investigation limited to diagnose proximal DVT, to be repeated after 5-7 days (or earlier) to exclude an extension to proximal veins of an IDDVT potentially present.", - "NCTID": "NCT00816920" - }, - { - "brief_title": "The Efficacy of Breathing Exercise With BreatheMAX Device on Airway Secretion Clearance and Lung Function", - "phase": "", - "drugs": "['BreatheMAX (OPEP)', 'BreatheMAX (OIS and OPEP)', 'BreatheMAX (unload and non-oscillated)']", - "drugs_list": [ - "BreatheMAX (OPEP)", - "BreatheMAX (OIS and OPEP)", - "BreatheMAX (unload and non-oscillated)" - ], - "diseases": "['Bronchial Secretion Retention']", - "diseases_list": [ - "Bronchial Secretion Retention" - ], - "enrollment": "28.0", - "inclusion_criteria": "inclusion criteria: \n\n Intubated patients (with and without mechanical ventilator support) with secretion 1.5 ml/h, If the patients are breathing with mechanical ventilation, the PEEP level must be less than 6 centimeter of water and one of following \n\n Clinical and radiologic diagnosis of pulmonary infection \n\n Acute or chronic airway inflammation disease such as pneumonia, bronchiectasis, chronic obstructive pulmonary disease or chronic bronchitis and at least one sign of secretion accumulation in bronchial such as medium-coarse crackle, wheezing, persistent rhonchi and decrease breath sound \n\n Stable of cardiopulmonary function at least 2 days before the study and the patients don't receive the vasopressors drug within 5 days before collects the data \n\n Stable of hydration status or positive fluid balance at least 2 days before collects the data \n\n Ability to breathe or tolerate spontaneously breathing trial with T-piece at least 2 minutes with fraction of inspired oxygen less than 0.4 and without developing hypoxemia \n\n Good conscious and well cooperation \n\n ", - "exclusion_criteria": ": \n\n Pneumothorax (nontreated) \n\n Massive hemoptysis \n\n Acute myocardial infarction (with angina chest pain) \n\n High intracranial pressure (>20 mm Hg) \n\n Major arrhythmia", - "brief_summary": "The efficacy of breathing exercise with oscillated inspiratory loading and oscillated positive expiratory pressure for airway secretion clearance and lung function in intubated patients, both with and without mechanical ventilation dependence", - "NCTID": "NCT02553200" - }, - { - "brief_title": "A Study of the Efficacy of Preventive Dosing of Fondaparinux Sodium Versus Placebo for the Prevention of Venous Thromboembolism (VTE) in Patients Undergoing Coronary Bypass Surgery Receiving Routine Mechanical Prophylaxis", - "phase": "", - "drugs": "['Fondaparinux', 'Placebo']", - "drugs_list": [ - "Fondaparinux", - "Placebo" - ], - "diseases": "['Deep Vein Thrombosis', 'Coronary Artery Bypass Surgery', 'Venous Thromboembolism']", - "diseases_list": [ - "Deep Vein Thrombosis", - "Coronary Artery Bypass Surgery", - "Venous Thromboembolism" - ], - "enrollment": "78.0", - "inclusion_criteria": "Subject inclusion criteria In order to be enrolled in the study, subjects must meet all of the inclusion criteria as listed below. \n\n Consecutive patients undergoing isolated or redo isolated CABG \n\n Patients must provide written informed consent \n\n Patients must agree to comply with study procedures for the entire length of the study. \n\n Must be 18 years old or greater. \n\n Subject ", - "exclusion_criteria": " Any subject that meets any of the ", - "brief_summary": "This trial is a prospective, single-center Phase II randomized study to demonstrate the superior efficacy of Fondaparinux Sodium subcutaneous injections in patients undergoing CABG surgery (isolated and redo isolated) versus treatment with placebo. All consecutive patients scheduled for CABG surgery that meet the general inclusion and none of the exclusion criteria will be considered for enrollment in the study.~Consecutive patients will be randomized on the day of admission prior to their CABG surgery into one of two groups. One group will be randomized to the placebo while the second group will receive 2.5 mg Fondaparinux Sodium injections. Both groups will receive routine mechanical prophylaxis as determined by the treating physicians. Group randomized to receive Fondaparinux Sodium will receive a 2.5 mg SQ daily drug dose starting 12 +/- 2 hours post-wound closure or the following day in the morning (at the discretion of the cardiothoracic surgeon). The second dose would be administered 24 hours later and the dosing will then be once a day. The group randomized to placebo will receive subcutaneous equivolume isotonic saline at the same time points described above.~Patients randomized will receive a 2.5 mg dose of Fondaparinux Sodium or placebo subcutaneously for a total of 3-9 days post CABG with day 1 being the day of surgery. The drug will be discontinued if the patient is discharged before day 9. If the patient stays for more than 9 days inside hospital, a duplex would be obtained per protocol and further DVT prevention measures would be instituted per the discretion of treating physician.~Patients will be assessed daily while hospitalized for any symptoms and adverse reactions and will undergo laboratory testing (CBC, PT/INR, PTT and UA) as specified in the protocol. Post-op day 3-9(no later than 2 days after the last preventive drug dose) patients will undergo the protocol specific lower limb venous duplex scan and earlier if symptomatic. Patients will also be contacted (phone/office visit) for follow-up 25-35 days post CABG to assess for signs or symptoms of deep venous thrombosis or thromboembolism and for any potential complications.", - "NCTID": "NCT00789399" - }, - { - "brief_title": "Alterations of Blood Clotting With the Use of Sequential Compression Devices on the Lower Limbs", - "phase": "", - "drugs": "['Sequential compression device therapy', 'Dalteparin', 'TEG']", - "drugs_list": [ - "Sequential compression device therapy", - "Dalteparin", - "TEG" - ], - "diseases": "['Coagulation, Blood', 'Compression Devices, Intermittent Pneumatic', 'Postoperative Complications', 'Thrombelastography']", - "diseases_list": [ - "Coagulation", - "Blood", - "Compression Devices", - "Intermittent Pneumatic", - "Postoperative Complications", - "Thrombelastography" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Elective major abdominal surgery for neoplasm \n\n Planned admission to postsurgical ICU due to the patient's meeting one or more of the following: \n\n ASA Physical Status Class 4 \n\n Surgery of modified Johns-Hopkins class \u2265IV \n\n ASA 3 with modified Johns-Hopkins class 3 surgery \n\n Expected duration of surgery \u22658 h \n\n ", - "exclusion_criteria": ": \n\n History of coagulation abnormalities, either congenital or acquired \n\n Ongoing treatment with anticoagulants/antiplatelet agents other than LMWH or hormones \n\n Massive edema of the legs \n\n Severe peripheral arteriopathy or neuropathy \n\n Malformations or recent surgery/trauma to the lower extremities", - "brief_summary": "This study aims to assess possible alteration in coagulation (blood clotting) following treatment with sequential compression devices (SCD) plus low-molecular weight heparin (LMWH) as opposed to LMWH alone.~The investigators will examine coagulation in the early postoperative period of patients undergoing major abdominal surgery during their stay in our Intensive Care Unit.~In addition to common laboratory tests, the investigators will examine coagulation using TEG\u00ae, a device which allows a semi-quantitative examination of all phases of coagulation.", - "NCTID": "NCT00726570" - }, - { - "brief_title": "Usefulness of Chest Wall Tenderness as Bedside Test to Exclude Acute Coronary Syndrome in Different Demographic Groups", - "phase": "", - "drugs": "['Clinical examination: chest wall tenderness']", - "drugs_list": [ - "Clinical examination: chest wall tenderness" - ], - "diseases": "['Chest Pain']", - "diseases_list": [ - "Chest Pain" - ], - "enrollment": "110.0", - "inclusion_criteria": "inclusion criteria: All patients over the age of 18 years presenting with the leading symptom of first time or recurrent acute chest pain in the emergency room of the Department of Internal Medicine, University Hospital of Zurich. \n\n ", - "exclusion_criteria": ": \n\n Missing informed consent. \n\n Cardiopulmonary unstable patients. \n\n No self reported chest pain. \n\n Recent thoracic surgery within1 year, inflammatory joint disease, fibromyalgia, cardiogenic shock.", - "brief_summary": "To determine the significance of a simple bedside clinical test (chest wall tenderness) to exclude myocardial ischemia in different demographic groups.", - "NCTID": "NCT01724996" - }, - { - "brief_title": "Incidence and Outcomes of Venous Thromboembolism", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cardiovascular Diseases', 'Lung Diseases', 'Pulmonary Embolism', 'Venous Thromboembolism']", - "diseases_list": [ - "Cardiovascular Diseases", - "Lung Diseases", - "Pulmonary Embolism", - "Venous Thromboembolism" - ], - "enrollment": "", - "inclusion_criteria": "No eligibility criteria", - "exclusion_criteria": "", - "brief_summary": "To identify the incidence cohort of Olmsted County Minnesota residents with deep venous thrombosis (DVT)/pulmonary embolism (PE) from 1966 through 1990. Episodes of DVT or PE acquired during hospitalization or in the community were identified for future studies.", - "NCTID": "NCT00005351" - }, - { - "brief_title": "Breath Analysis Technique to Diagnose Pulmonary Embolism", - "phase": "Phase 2; Phase 3", - "drugs": "['BreathScreen PE']", - "drugs_list": [ - "BreathScreen PE" - ], - "diseases": "['Pulmonary Embolism']", - "diseases_list": [ - "Pulmonary Embolism" - ], - "enrollment": "475.0", - "inclusion_criteria": "Phase I inclusion criteria: \n\n Experienced or is scheduled for at least one of the following: \n\n Hip or knee replacement surgery \n\n Hip or acetabular fracture surgery \n\n Pelvic fracture \n\n Decompression for spinal stenosis surgery \n\n Scoliosis corrective surgery \n\n Craniotomy surgery for brain tumor \n\n Surgery for any of the following cancers: bladder, colon (including caecum and rectum), kidney, ovary, pancreas, or uterus \n\n Phase I ", - "exclusion_criteria": ": \n\n Currently undergoing treatment for PE or has received treatment for PE in the 4 weeks prior to study entry \n\n Hospitalized for fewer than 2 days \n\n Anatomic abnormality that would prevent use of a mouthpiece \n\n Living situation that makes follow-up difficult (e.g., homeless, incarcerated) \n\n Phase II inclusion criteria: \n\n Clinical suspicion of PE with signs or symptom suggestive of PE within 24 hours of presentation and at least one risk factor for PE, as defined under the criteria as outlined in this protocol \n\n CTA of pulmonary arteries ordered by clinical care providers \n\n 18 years or older or an emancipated 17 year old \n\n Written informed consent \n\n Phase II ", - "brief_summary": "A pulmonary embolism (PE) is a blockage in one of the arteries of the lungs, and is usually caused by a traveling blood clot. The D-dimer blood test is currently used to diagnose PEs, but it is not always accurate for individuals who have recently undergone surgery or who have inflammatory-provoking diseases. The purpose of this study is to evaluate the effectiveness of the Carboximeter, a new PE diagnostic device that measures carbon dioxide (CO2) and oxygen (O2) output, in individuals at risk for developing PEs.", - "NCTID": "NCT00368836" - }, - { - "brief_title": "PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT Pilot)", - "phase": "Phase 3", - "drugs": "['Fragmin (Dalteparin) LMWH verus Unfractionated Heparin (UFH)']", - "drugs_list": [ - "Fragmin (Dalteparin) LMWH verus Unfractionated Heparin (UFH)" - ], - "diseases": "['Critically Ill', 'Deep Venous Thrombosis']", - "diseases_list": [ - "Critically Ill", - "Deep Venous Thrombosis" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Admission to ICU \n\n Men and women greater than 18 years of age or older \n\n Expected to remain in ICU admission greater than 72 hours \n\n ", - "exclusion_criteria": ": \n\n Contraindications to LMWH or blood products \n\n Trauma, post orthopedic surgery, post cardiac surgery or post neurosurgery patients, \n\n Uncontrolled hypertension as defined by a systolic blood pressure > 180 mmHg or a diastolic blood pressure > 110 mmHg, \n\n Hemorrhagic stroke, DVT, PE or major hemorrhage on admission or within 3 months, \n\n Coagulopathy as defined by INR >2 times upper limit of normal [ULN], or PTT >2 times ULN, \n\n Renal insufficiency as defined by a creatinine clearance <30ml/min, \n\n A need for oral or intravenous or subcutaneous therapeutic anticoagulation, \n\n Heparin allergy, proven or suspected heparin-induced thrombocytopenia (HIT), \n\n Receipt of >2 doses of UFH or LMWH in ICU, \n\n Pregnant or lactating, \n\n Withdrawal of life support or limitation of life support, \n\n Prior enrollment in this trial \n\n Prior enrollment into a related RCT \n\n Thrombocytopenia defined platelet count < 100 x 109/L, \n\n Bilateral lower limb amputation, \n\n Allergy to pork or pork products", - "brief_summary": "PROTECT Pilot objective is to assess: 1) the feasibility of timely enrollment and complete, blinded study drug administration, 2) the bioaccumulation of LMWH in patients with acquired renal insufficiency and its association with bleeding, 3) the feasibility of scheduled twice weekly lower limb ultrasounds, and 4) recruitment rates for a future randomized trial.", - "NCTID": "NCT00182364" - }, - { - "brief_title": "Dalteparin's Influence on Renally Compromised: Anti-Ten-A Study (DIRECT)", - "phase": "", - "drugs": "['Fragmin (dalteparin sodium)']", - "drugs_list": [ - "Fragmin (dalteparin sodium)" - ], - "diseases": "['Renal Insufficiency']", - "diseases_list": [ - "Renal Insufficiency" - ], - "enrollment": "140.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult patient aged > 18 years \n\n Admitted to an ICU with an expected ICU length of stay > 72 hours \n\n Severe renal insufficiency, defined by a calculated CrCl < 30 mL/min/1.73m2 \n\n ", - "exclusion_criteria": ": \n\n ICU admission for > 2 weeks at time of screening \n\n ICU admission within 3 months of cardiac surgery or neurosurgery \n\n Active bleeding or at high risk for bleeding complications \n\n Thrombocytopenia (platelet count < 75 x 10^9/L) at time of screening \n\n Coagulopathy (International Normalized Ratio [INR] or activated partial thromboplastin time [aPTT] > 2 times upper limit of normal) at time of screening \n\n Patient had an indwelling epidural catheter for epidural analgesia within the last 12 hours \n\n Receipt of > 2 doses of LMWH (prophylactic- or therapeutic-dose) in the ICU \n\n Receiving or requiring therapeutic-dose anticoagulation (eg., deep vein thrombosis [DVT]) at time of screening \n\n Receiving dialysis that requires anticoagulation (eg., PRISMA, slow continuous ultrafiltration [SCUF]) at time of screening \n\n Weight < 45 kg \n\n Woman who is pregnant or lactating \n\n Bilateral lower limb amputation \n\n Previous adverse reaction to heparin or LMWH (eg., allergy, heparin-induced thrombocytopenia [HIT]) \n\n Contraindication to receiving blood products \n\n Life expectancy < 14 days or receiving palliative care \n\n Prior enrolment in this study or enrolment in a concurrent related clinical trial \n\n Patient or surrogate decision-maker does not provide consent to participate in study", - "brief_summary": "The investigators' primary research objective is:~To determine the safety of dalteparin prophylaxis, 5,000 IU once-daily, in Intensive Care Unit (ICU) patients based on:~the proportion of patients with trough anti-Xa > 0.40 IU/mL during dalteparin prophylaxis after 3 + 1 days, 10 + 1 days, and 17 + 1 days of dalteparin prophylaxis;~the risk of major bleeding during the treatment period.~The investigators' secondary research objectives are:~To determine the pharmacokinetic properties of dalteparin prophylaxis in ICU patients with severe renal insufficiency;~To identify clinical and laboratory factors that predict an excessive anticoagulant effect (anti-Xa > 0.10 IU/mL);~To estimate the relationship between trough anti-Xa levels and bleeding.~The DIRECT Pilot Study:~Before embarking on a large trial of low molecular weight heparin (LMWH) versus standard unfractionated heparin (UFH), the DIRECT Study is needed to observe whether bioaccumulation of LMWH occurs in ICU patients with moderate to severe renal insufficiency, and to address potential problems with protocol implementation.", - "NCTID": "NCT00138099" - }, - { - "brief_title": "ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)", - "phase": "Phase 2", - "drugs": "['SB-424323', 'Placebo']", - "drugs_list": [ - "SB-424323", - "Placebo" - ], - "diseases": "['Arthroplasty']", - "diseases_list": [ - "Arthroplasty" - ], - "enrollment": "343.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients scheduled for primary elective unilateral total hip arthroplasty (i.e. first time the hip is being replaced on the operative side). \n\n Patients who have given written informed consent to participate in this study. \n\n ", - "exclusion_criteria": ": \n\n Patients with a contraindication to contrast venography \n\n Patients with an increased risk of bleeding. \n\n Patients with a predefined risk for prethrombotic episodes or a history of thrombophilia. \n\n Other inclusion or ", - "brief_summary": "The purpose of this study is to gain additional safety information as well as to determine after the study drug has been given to patients who have undergone total hip replacement surgery, whether the study drug is effective in preventing late deep vein thrombosis (blood clots in legs) or pulmonary embolism (blood clots in lungs).", - "NCTID": "NCT00041509" - }, - { - "brief_title": "Study Comparing Desirudin With Heparin to Prevent Vein Clots After Heart and Lung Surgery", - "phase": "Phase 2; Phase 3", - "drugs": "['Desirudin (Iprivask\u2122)', 'Heparin']", - "drugs_list": [ - "Desirudin (Iprivask\u2122)", - "Heparin" - ], - "diseases": "['Deep Venous Thrombosis']", - "diseases_list": [ - "Deep Venous Thrombosis" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who are scheduled for elective Cardiac or Thoracic Surgery. \n\n Age > 18 years of age. \n\n ", - "exclusion_criteria": ": \n\n Patients with a clinical suspicion or a documented history of DVT/PE \n\n Patients who may require anticoagulation during the post-op period. (i.e. Patients with a history of A-fib, scheduled for a MAZE procedure or placement of a mechanical valve, or those on Coumadin/IV heparin preoperatively) \n\n Patients who have a history of HIT or if there is a suspicion of the patient having HIT pre-operatively. \n\n Documented allergy to heparin, desirudin, or lepirudin \n\n Patients with a history of coagulation disorder \n\n Platelet count< 100 X109 /dl \n\n Active bleeding \n\n Serum Creatinine \u2265 1.5 mg/dl or CrCl \u2264 30 ml/min \n\n Patients with a baseline coagulopathy (INR > 1.5 or aPTT > 45 sec) \n\n Patients with liver disease \n\n Pregnancy \n\n Patients who require ventricular assist devices before or after surgery", - "brief_summary": "A blood clot in the veins, also known as deep venous thrombosis (DVT), is one of the most common complications after surgery. This may result in death if a clot breaks off and travel to the lungs; this is referred to as pulmonary embolism (PE). After heart surgery the incidence of DVT ranges from 20-48% and following lung surgery the incidence is 19-26%. In order to decrease the likelihood of this complication, patients receive by injection a blood thinning medicine. Heparin is the usual medicine used for this purpose following heart and lung surgery. Recently there have been reports that other medicines may be more effective than heparin for this purpose. Also there have been reports that some patients develop antibodies to heparin. When this occurs, this may prevent the heparin from being effective and may even promote the formation of blood clots. Antibodies to heparin may be present more often following heart and lung surgery than other types of surgery. There is a new medicine called desirudin (Iprivask), which may be used instead of heparin to prevent blood clots following heart and lung surgery. Desirudin is currently approved by the FDA to prevent blood clots following hip surgery. The purpose of this study is to compare desirudin with heparin for the prevention of vein clots after heart and lung surgery.", - "NCTID": "NCT00329433" - }, - { - "brief_title": "Apixaban Pharmacokinetics in Bariatric Patients (APB)", - "phase": "Phase 4", - "drugs": "['Apixaban']", - "drugs_list": [ - "Apixaban" - ], - "diseases": "['Bariatric Surgery', 'Obesity']", - "diseases_list": [ - "Bariatric Surgery", - "Obesity" - ], - "enrollment": "33.0", - "inclusion_criteria": "inclusion criteria: \n\n Men or women, 18 to 65 years old with a BMI of 35 kg/m2 or greater who will be undergoing bariatric surgery (VSG and RYGB) \n\n Signed written informed consent \n\n Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug \n\n Women must not be breastfeeding \n\n ", - "exclusion_criteria": ": \n\n History of documented clotting/coagulation disorder \n\n History of cancer (within the last year) \n\n Any diagnosis requiring anti-coagulation \n\n History of hypersensitivity reaction to apixaban \n\n Active clinically significant bleeding \n\n Creatinine > 1.5 mg/dL \n\n Participants currently receiving any type of anticoagulation or blood thinning medications, including heparin, low molecular weight heparins, Plavix, aspirin, NSAIDS \n\n Participant who is taking any of the excluded medications \n\n Combined P-glycoprotein and strong cytochrome P450 (CYP) 3A4 inhibitor \n\n Combined P-glycoprotein and moderate CYP 3A4 inhibitor \n\n Combined P-glycoprotein inducer and strong CYP 3A4 inducer \n\n Inducers of p-glycoprotein \n\n Strong inducers of CYP 3A4", - "brief_summary": "The Center for Bariatric Surgery is interested in conducting a pharmacokinetic study of apixaban (an oral anticoagulant with FDA approval for use of venous thrombo embolism (VTE) prophylaxis and treatment) in the obese adult population to determine if bariatric surgery influences apixaban exposure. More interesting would be to see how the dose may need to change pre- vs. post-bariatric surgery (this will be important for physicians as more and more patients undergo this procedure worldwide and many may require anticoagulation in their future healthcare).~Physicians and surgeons are very interested in oral anticoagulants for this special patient population. To date, there is no approved dosing for the obese patient (especially when considering surgical intervention such as bariatric surgery).~Primary outcome variable.~To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater following one of two bariatric surgical procedures (pre-operative versus post-operative vertical sleeve gastrectomy or Roux-en-Y gastric bypass patients).~Secondary outcome variables.~To compare/contrast the pharmacokinetics and pharmacodynamics of apixaban in bariatric surgical patients who have undergone RYGB vs. VSG.~To determine how the pharmacokinetics of the drug may differ when there is significant post-operative surgical weight loss (>40% estimated excess body weight) 12 to 18 months following surgery versus those patients who have suboptimal weight loss following bariatric surgery (< 40% of estimated excess body weight).", - "NCTID": "NCT02406885" - }, - { - "brief_title": "Comparative Analysis of Injectable Anticoagulants for Thromboprophylaxis Post Cancer-related Surgery", - "phase": "", - "drugs": "['dalteparin', 'enoxaparin', 'fondaparinux', 'unfractionated heparin']", - "drugs_list": [ - "dalteparin", - "enoxaparin", - "fondaparinux", - "unfractionated heparin" - ], - "diseases": "['Thrombosis, Venous']", - "diseases_list": [ - "Thrombosis", - "Venous" - ], - "enrollment": "4068.0", - "inclusion_criteria": "inclusion criteria: \n\n age 18 and older \n\n at least one record of a primary inpatient discharge diagnosis of cancer (index hospitalization) \n\n a procedure code for a cancer-related surgery during the index hospitalization \n\n a code for an anticoagulant treatment (dalteparin, enoxaparin, fondaparinux or unfractionated heparin (UFH)) as thromboprophylaxis therapy during the day prior to or two days after cancer-related surgery during the index hospitalization (this is the INDEX EVENT) \n\n ", - "exclusion_criteria": ": \n\n a record that the patient received more than one injectable anticoagulant on Day 1 of anticoagulant therapy \n\n a record that the patient received anticoagulant therapy prior to index anticoagulant \n\n a primary diagnosis code of DVT, PE, or major bleed \n\n evidence of an outpatient emergency department or hospital outpatient clinic visit that included a diagnosis code for DVT or PE during the 6 months prior to the index hospitalization \n\n patient records for patients transferred from another facility outside Premier system on index hospitalization", - "brief_summary": "Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common post-operative complication. The effectiveness of fondaparinux compared with other injectable anticoagulants in VTE following major orthopedic and abdominal surgery has been evaluated in database studies; however, the effectiveness of injectable anticoagulant medications following cancer-related surgeries in the practice setting has not been as well documented.~The objective of this study is to analyze patient records from a national hospital database and compare the outcomes and costs between four types of injectable anticoagulant medications that were prescribed for the prevention of VTE following cancer-related surgery. This analysis will assess and quantify the outcomes, resource utilization, and cost of care for patients receiving fondaparinux, enoxaparin, dalteparin or unfractionated heparin. The outcomes of interest include the occurence of VTE, rates of major bleeds, medical resource utilization, and total costs (medical plus pharmacy).~The source of data for this study is the Premier Perspective Database\u2122. This hospital claims database links de-identified inpatient medical, pharmacy, and billing data from more than 500 hospitals.~This study is a retrospective cohort study that uses propensity score matching to adjust for the differences between the numbers of patients treated with each medication.", - "NCTID": "NCT01444612" - }, - { - "brief_title": "Left Rule, D-Dimer Measurement and Complete Ultrasonography to Rule Out Deep Vein Thrombosis During Pregnancy.", - "phase": "", - "drugs": "['Left rule, D-dimer measurement and complete ultrasonography in pregnant women.']", - "drugs_list": [ - "Left rule", - "D-dimer measurement and complete ultrasonography in pregnant women." - ], - "diseases": "['Pregnancy', 'Deep Vein Thrombosis']", - "diseases_list": [ - "Pregnancy", - "Deep Vein Thrombosis" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Pregnant women with clinically suspected DVT \n\n ", - "exclusion_criteria": ": \n\n Age less than 18 \n\n No available informed consent \n\n Associated suspicion of pulmonary embolism \n\n Ongoing anticoagulant treatment \n\n Planned anticoagulant treatment at therapeutic dosage during pregnancy", - "brief_summary": "In pregnant women with suspected DVT, a sure diagnosis is mandatory. In non-pregnant patients, sequential diagnostic strategies based on 1) the assessment of clinical probability, 2) D-dimer measurement and 3) compression ultrasonography (CUS) have been well validated.~Clinical probability assessment by clinical prediction rules (CPRs) is a crucial step in the management of suspected DVT. However, the most commonly used CPR for DVT, the Wells' score, has never been validated in pregnant women. Recently, the 'LEFt' clinical prediction rule was derived and internally validated. A prospective validation of this rule is now warranted, and we plan to use it in our prospective study.~The second step used in the diagnostic strategy including non-pregnant patients is D-dimer measurement. The test has been widely validated in non-pregnant patients and, in association with a non-high clinical probability, it allows to safely rule out DVT.~As D-dimer level raise steadily during pregnancy, the specificity of the test decreases and it is less useful in pregnant women. Data from the literature clearly suggest that the usual cut-off set a 500 ng/ml would safely rule out DVT in pregnant women [6]. As the usual cut-off has never been prospectively validated in pregnant women with suspected DVT, we would like to use it in our study.~Some studies suggested that complete CUS is safe to rule out DVT in pregnant women. However, this test is not always available. Therefore, a strategy in which the association of clinical probability assessment and D-dimer measurement would allow to safely rule out DVT in a significant proportion of patients without performing a complete CUS, would be of great help in everyday clinical practice and would probably be cost-effective.~Therefore, we plan a prospective study to assess the safety of a sequential diagnostic strategy based on the assessment of clinical probability with the LEFt rule, D-dimer measurement and complete CUS in pregnant women with suspected DVT.", - "NCTID": "NCT01708239" - }, - { - "brief_title": "Pediatric Catheter-related Thrombosis Imaging Study", - "phase": "", - "drugs": "['Ultrasound', 'Magnetic Resonance Imaging with Contrast', 'Magnetic Resonance Imaging without Contrast']", - "drugs_list": [ - "Ultrasound", - "Magnetic Resonance Imaging with Contrast", - "Magnetic Resonance Imaging without Contrast" - ], - "diseases": "['Thrombosis']", - "diseases_list": [ - "Thrombosis" - ], - "enrollment": "151.0", - "inclusion_criteria": "inclusion criteria: \n\n Functioning central venous catheter in the upper or lower venous system \n\n Cohort A: Asymptomatic patients having placement of a new central venous catheter in the last 40\u00b120 days \n\n Cohort B: Subjects who have experienced symptoms for a CVC-related DVT with a CVC in place or subjects who have been incidentally identified by radiographic imaging (imaging modalities to diagnose an incidental CVC-related DVT may include, but is not exclusive of Echocardiogram, CT scan, MRI, or Ultrasound) performed for other clinical reasons, as having a CVC-related DVT in the veins where the current catheter is placed \n\n Males and females from full-term newborns to < 18 years \n\n ", - "exclusion_criteria": ": \n\n For Cohort A subjects only, present therapeutic dosing of a systematic anticoagulant, systemic thromboprophylaxis or antiplatelet therapy. Local thromboprophylaxis [flushes, low dose infusions of heparin of up to 5 u/kg/hr or locks with heparin, urokinase, t-plasminogen activator] according to standard-of-care at the respective center will be allowed \n\n Patients unable to undergo contrast enhanced magnetic resonance imaging \n\n Renal function < 50% of normal for age and size", - "brief_summary": "This protocol will serve as a pilot study to determine the validity and feasibility of contrast enhanced magnetic resonance imaging (MRI) without and with contrast and/or ultrasound (US) for detection of catheter related deep vein thrombosis (DVT) in children", - "NCTID": "NCT01137578" - }, - { - "brief_title": "Preventing the Development of Venous Insufficiency in Pregnant Women Through Use of Compression Stockings", - "phase": "", - "drugs": "['Compression Stockings']", - "drugs_list": [ - "Compression Stockings" - ], - "diseases": "['Venous Insufficiency']", - "diseases_list": [ - "Venous Insufficiency" - ], - "enrollment": "44.0", - "inclusion_criteria": "inclusion criteria: \n\n Pregnant women 18-45 years of age. \n\n Fetal gestation between 8-20 weeks. \n\n Patient is seeking care for the pregnancy at one of the study locations (Johns Hopkins East Baltimore Campus, Johns Hopkins Bayview Medical Center, and Johns Hopkins at White Marsh). \n\n Ability to complete informed consent and willingness to comply with protocol (return for all follow-up visits & participate in phone interviews). \n\n ", - "exclusion_criteria": ": \n\n Inability to wear compression stockings. \n\n Women who currently have been prescribed to wear compression stockings by a medical professional. \n\n Chronic dermatological condition (i.e. psoriasis). \n\n Chronic deep vein thrombus or chronic phlebitis. \n\n In women with varicose veins: Presence of primary outcome (superficial thrombophlebitis or DVT) on first visit ultrasound.", - "brief_summary": "Problem: Approximately 4 million live births occur in the United States each year. Pregnancy causes many physical changes in the mother, including venous distension, increased ability to form blood clots, and hormonal changes. Data suggest that these factors help cause venous insufficiency (when the veins do not adequately return blood from the extremities to the torso). As venous insufficiency progresses, complications follow, the most severe of which include superficial thrombophlebitis and deep venous thrombosis (DVT, or blood clots). Although the fear of DVT has been well publicized, its prevention and prevalence in pregnant women has not been well-studied.~The exact cause of venous insufficiency is not known. However, known risk factors include being female and hormonal changes associated with oral contraceptive use, certain hormone replacement medications, and pregnancy. Being pregnant places the mother at additional risk for developing venous insufficiency.~Compression stockings are used to manage the condition, but this is by no means standard of care despite their easy use and safety. The medical community's understanding of how compression stockings work is largely theoretical; however, it is believed that the compression works by preventing venous hypertension in the lower legs, thereby preventing venous insufficiency and its associated complications.~Research hypothesis: The investigators hypothesize that compression stocking use will be associated with lower incidence of varicose veins and, in those patients who already have varicose veins, lower incidence of complications associated with venous insufficiency. Further, the investigators believe that compression stocking use will be associated with a lower incidence or lessening of symptoms associated with venous insufficiency.~Importance: An undetected DVT can be fatal. Even if detected promptly, DVT is associated with long term health problems. Treatment of a DVT requires anticoagulation which can be risky to both mother and fetus. The prevention or reduction of DVT in pregnant women through use of compression stockings would revolutionize their care. Further, this intervention is safe and noninvasive.~The investigators propose to conduct a randomized, pilot study comparing pregnant women without and with varicose veins randomized to wear compression stockings to a similar group of participants randomized to no compression stocking use.", - "NCTID": "NCT01793194" - }, - { - "brief_title": "Pulmonary Embolism in Exacerbations of Chronic Obstructive Pulmonary Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pulmonary Embolism', 'Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Pulmonary Embolism", - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "38.0", - "inclusion_criteria": "inclusion criteria: \n\n known or suspected COPD \n\n COPD-exacerbation \n\n ", - "exclusion_criteria": ": \n\n other causes of dyspnea \n\n unable to perform CT pulmonary angio (contrast allergy, pregnancy) \n\n already included in the study (each patient included only once) \n\n use of anticoagulants", - "brief_summary": "The purpose of this study is to determine the prevalence of pulmonary embolism in our population of Chronic Obstructive Pulmonary Disease (COPD) patients admitted to hospital with dyspnea. The patients will undergo investigation for pulmonary embolism, according to current guidelines.", - "NCTID": "NCT01318174" - }, - { - "brief_title": "The Incidence of Perioperative Deep Venous Thromboses of the Lower Extremities", - "phase": "", - "drugs": "['Duplex scan of lower extremities']", - "drugs_list": [ - "Duplex scan of lower extremities" - ], - "diseases": "['Perioperative DVTs']", - "diseases_list": [ - "Perioperative DVTs" - ], - "enrollment": "1000.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18+ and consentable \n\n ", - "exclusion_criteria": ": \n\n Anticoagulation therapy or known DVT", - "brief_summary": "The study's hypothesis is that there are some patients who come for surgery who have asymptomatic clots in their lower extremities upon their arrival to the hospital for their surgical admission. We will be performing duplex studies of the subjects' legs before their surgery to determine how often clots are present. We will also perform duplex scans of the legs after the subjects' surgeries to determine what factors (surgical, anesthetic, co-morbidities)are correlated with the development of DVTs.", - "NCTID": "NCT01300832" - }, - { - "brief_title": "Influence of Tourniquet Use and Surgery Duration on the Incidence of Deep Vein Thrombosis in Total Knee Arthroplasty", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Deep Vein Thrombosis']", - "diseases_list": [ - "Deep Vein Thrombosis" - ], - "enrollment": "78.0", - "inclusion_criteria": "inclusion criteria: \n\n patients that underwent cemented total knee arthroplasty \n\n ", - "exclusion_criteria": ": \n\n post-operative infection \n\n inadequate follow-up", - "brief_summary": "This is an observational study to analyze the influence of surgery duration and tourniquet time in the incidence of deep venous thrombosis (DVT) in patients that had undergone total knee arthroplasty (TKA).", - "NCTID": "NCT01559532" - }, - { - "brief_title": "Pot-Cast: Thrombosis Prophylaxis During Plaster Cast Lower Leg Immobilisation", - "phase": "", - "drugs": "['LMWH']", - "drugs_list": [ - "LMWH" - ], - "diseases": "['Deep Venous Thrombosis', 'Pulmonary Embolism']", - "diseases_list": [ - "Deep Venous Thrombosis", - "Pulmonary Embolism" - ], - "enrollment": "1500.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients in need of immobilization of the lower leg with a plaster cast (or equivalent of a cast) for a minimum of one week for the following indications: \n\n Trauma of the lower leg \n\n Surgery of the lower leg followed by lower leg immobilization with a plaster cast \n\n Non-traumatic indications \n\n ", - "exclusion_criteria": ": \n\n Contra-indications for LMWH use (recent major bleeding, bleeding disorder, allergy) \n\n Pregnancy \n\n Pre-existent indication for anticoagulation therapy, either LMWH or vitamin K antagonists. \n\n History of venous thromboembolism (indication for anticoagulation therapy for prophylaxis of recurrence) \n\n Mental of physical disability to fulfill study requirements \n\n Insufficient knowledge of the Dutch language \n\n Previous participation in the Pot-(K)Cast study", - "brief_summary": "Currently, guidelines and clinical practice differ considerably with respect to use of anticoagulant treatment during cast immobilization of the lower leg. Trials that have been carried out were aimed at efficacy only, had small sample sizes and therefore mainly used asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could not be established, hence the current controversy. In the proposed study the investigators will use relevant symptomatic endpoints in a large cohort of patients. Furthermore the investigators will follow subjects with an adverse event for a longer period, during which the investigators will assess the long term sequelae of these events. Lastly, the investigators will determine high risk groups that will benefit most from anticoagulant treatment.~Objective: Comparative effectiveness research to determine cost-effectiveness of two existing policies, i.e. treatment with low molecular weight heparin (LMWH) during lower leg plaster cast immobilization following surgical or conservative treatment. In addition the investigators will investigate personalized prophylaxis based on genetic and acquired risk factors.", - "NCTID": "NCT01542762" - }, - { - "brief_title": "Pot-Kast: Thrombosis Prophylaxis After Knee Arthroscopy", - "phase": "", - "drugs": "['LMWH']", - "drugs_list": [ - "LMWH" - ], - "diseases": "['Deep Venous Thrombosis', 'Pulmonary Embolism']", - "diseases_list": [ - "Deep Venous Thrombosis", - "Pulmonary Embolism" - ], - "enrollment": "1500.0", - "inclusion_criteria": "inclusion criteria: \n\n Meniscectomy \n\n Diagnostic Arthroscopy \n\n Removal of corpora libera \n\n ", - "exclusion_criteria": ": \n\n Contra-indications for LMWH use (recent major bleeding, bleeding disorder, allergy) \n\n Pregnancy \n\n Pre-existent indication for anticoagulation therapy, either LMWH or vitamin K antagonists. \n\n History of venous thromboembolism (indication for anticoagulation therapy for prophylaxis of recurrence) \n\n Mental of physical disability to fulfill study requirements \n\n Insufficient knowledge of the Dutch language \n\n Previous participation in the Pot-(K)Cast study", - "brief_summary": "Currently, guidelines and clinical practice differ considerably with respect to use of anticoagulant treatment after arthroscopy of the knee. Trials that have been carried out were aimed at efficacy only, had small sample sizes and therefore mainly used asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could not be established, hence the current controversy. In the proposed study the investigators will use relevant symptomatic endpoints in a large cohort of patients. Furthermore the investigators will follow subjects with an adverse event for a longer period, during which the investigators will assess the long term sequelae of these events. Lastly, the investigators will determine high risk groups that will benefit most from anticoagulant treatment.~Objective: Comparative effectiveness research to determine cost-effectiveness of two existing policies, i.e. treatment with low molecular weight heparin (LMWH) after arthroscopy of the knee. In addition the investigators will investigate personalized prophylaxis based on genetic and acquired risk factors.", - "NCTID": "NCT01542723" - }, - { - "brief_title": "Physical Fitness and Nutrition Intake in Bariatric Surgery Population", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Obesity']", - "diseases_list": [ - "Obesity" - ], - "enrollment": "73.0", - "inclusion_criteria": "inclusion criteria: \n\n Competent patients enrolled in the pre- or post-operative bariatric surgery program at the Center for Nutrition and Weight Management at GMC, Danville, PA. \n\n Ability to perform a 6 Minute Walk Test. \n\n Aged 18 through 70. \n\n Willingness to receive dietary recall phone calls and accessibility to a telephone. \n\n ", - "exclusion_criteria": ": \n\n Patients with severe lung disease requiring oxygen therapy. \n\n Pulmonary embolus or pulmonary infarction. \n\n Patients with cardiopulmonary disease (e.g., prior myocardial infarction, coronary artery bypass, or vascular stent). \n\n Unstable angina. \n\n Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise. \n\n Patients with any health reason that limits walking. \n\n Patients with a temporary injury that limits walking. \n\n Patients who use a wheelchair, other assistive device for walking, or have difficulty ambulating during activities of daily living. \n\n Patients predetermined to be illiterate or incompetent. \n\n Patients who are currently pregnant or have been pregnant at any time since bariatric surgery. \n\n Tobacco use. \n\n Patients with electronic defibrillators or other embedded electronic medical devices. \n\n Acute systemic infection, accompanied by fever, body aches, or swollen lymph glands \n\n Patients who have undergone revisional bariatric surgery.", - "brief_summary": "The purpose of this research study is to determine how bariatric surgery affects physical activity and nutrient intake.~This research study is being done because the investigators want to determine better recommendations to provide to bariatric surgery patients.", - "NCTID": "NCT02070354" - }, - { - "brief_title": "Atrial Fibrillation Ablation The Hybrid Approach Versus Traditional Management", - "phase": "Phase 1", - "drugs": "['Pulmonary vein isolation ablation procedure for atrial fibrillation', 'Hybrid procedure for ablation of atrial fibrillation', 'The Cox Maze Procedure for Ablation of Atrial Fibrillation', 'Hybrid Procedure for Left Atrium >5 cm but < 6.1 cm']", - "drugs_list": [ - "Pulmonary vein isolation ablation procedure for atrial fibrillation", - "Hybrid procedure for ablation of atrial fibrillation", - "The Cox Maze Procedure for Ablation of Atrial Fibrillation", - "Hybrid Procedure for Left Atrium >5 cm but < 6.1 cm" - ], - "diseases": "['Ablation of Atrial Fibrillation']", - "diseases_list": [ - "Ablation of Atrial Fibrillation" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients will be included if they present for ablation with paroxysmal or persistent atrial fibrillation as defined by the Heart Rhythm Society and their left atrium is < 6.1 cm (volume) \n\n Patients must be symptomatic with their AF as noted by their inability to perform their daily activities due to shortness of breath, fatigue, palpitations or other debilitating symptoms \n\n Paroxysmal atrial fibrillation is defined as atrial fibrillation that resolves on its own within 7 days of onset \n\n Persistent atrial fibrillation is defined as atrial fibrillation that does not resolve on its own and requires medical intervention to include medication therapy and/or electric cardioversion \n\n ", - "exclusion_criteria": ": \n\n Patients will be excluded if they present with long standing persistent atrial fibrillation as defined by the Heart Rhythm Society \n\n All patients with MV +2 mitral regurgitation will be excluded \n\n Require other cardiac surgery procedures will be excluded \n\n Are unable to take anticoagulation \n\n Are unable to take any prescribed anti arrhythmic medication \n\n Have a left atrium measuring greater than 6.0 cm (volume) \n\n Have had previous catheter ablation for atrial fibrillation \n\n Have had previous pace maker implantation \n\n Are less than 18 years of age \n\n Do not speak English and no translation can be provided \n\n Are unable or unwilling to be followed according to set protocol to include obtaining an internally heart monitor 6 weeks prior to their ablation procedure", - "brief_summary": "Rationale: To determine the most beneficial ablation methodology for individual patients with paroxysmal or persistent atrial fibrillation (defined by the Heart Rhythm Society) as surgeons and electrophysiologists work together on a convergent procedure (hybrid) to place the epicardial and endocardial ablation lines.~Objectives: Catheter and surgical ablation are being offered today to patients with drug refractory and symptomatic atrial fibrillation. This study is designed to assess the most efficient ablation approach in patients with paroxysmal and persistent atrial fibrillation. In patients with left atrium size of less than 5.0 cm, a Hybrid approach (pulmonary vein isolation performed surgically will be combined with right and left atrial flutter lines performed using a transcatheter approach) will be compared to percutaneous catheter ablation to isolate the pulmonary veins and apply the left and right atrial flutter lines with removal of LA appendage. In the group of patients with left atrial size 5.0-6.0 cm the Hybrid approach is going to be compared to the minimally invasive Cox-Maze III procedure.~Our hypotheses with regard to the rate of return to sinus rhythm off antiarrhythmic drugs at 6 months will demonstrate that the Hybrid approach is going to be a: superior to percutaneous catheter ablation in the less than 5 cm left atrial group and b: non-inferior when compared to the Cox-Maze III procedure in the 5-6 cm left atrial cm group.~We hypothesize that the safety of all procedures will show no differences and that there will be no differences in clinical complications between groups.", - "NCTID": "NCT01298986" - }, - { - "brief_title": "Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility", - "phase": "Phase 3", - "drugs": "['Semuloparin sodium', 'Enoxaparin sodium']", - "drugs_list": [ - "Semuloparin sodium", - "Enoxaparin sodium" - ], - "diseases": "['Venous Thromboembolism']", - "diseases_list": [ - "Venous Thromboembolism" - ], - "enrollment": "421.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient with an acute medical condition requiring bed rest for at least 3 days, and hospitalized for at least one of the following medical conditions: \n\n Congestive heart failure (New York Heart Association [NYHA] class III/IV); \n\n Acute respiratory failure (not requiring mechanical ventilation); \n\n Acute infection (without septic shock)*; \n\n Acute rheumatic disorder*; \n\n Acute episode of inflammatory bowel disease*. \n\n Patient with one of these conditions should have at least one additional risk factor for venous thromboembolism (VTE) among the following: \n\n Age \u2265 75 years; \n\n Active cancer or myeloproliferative disorders (having received treatment for cancer within the last 6 months); \n\n Previous VTE; \n\n Obesity; \n\n Oral hormone therapy (antiandrogen or estrogen); \n\n Chronic heart failure; \n\n Chronic respiratory failure. \n\n ", - "exclusion_criteria": ": \n\n Previous surgery with general anesthesia within 30 days before inclusion in the study; \n\n Patient requiring a curative anticoagulant or thrombolytic treatment; \n\n Patient at risk of bleeding; \n\n Stroke; \n\n Known hypersensitivity to heparin or enoxaparin sodium; \n\n End stage renal disease or patient on dialysis. \n\n The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.", - "brief_summary": "The primary objective was to compare the efficacy of once daily [q.d] subcutaneous [s.c.] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the primary prevention of Venous Thromboembolic Events [VTE] in patients hospitalized for acute medical illness.~The secondary objectives were to evaluate the safety of AVE5026 and to document AVE5026 exposure in this population.", - "NCTID": "NCT00714597" - }, - { - "brief_title": "Anti Xa Levels Under Two Different Regimens of Enoxaparin VTE Prophylaxis After Sleeve Gastrectomy for Morbid Obesity", - "phase": "Phase 4", - "drugs": "['40mg Enoxaparin', '60mg Enoxaparin', 'Control']", - "drugs_list": [ - "40mg Enoxaparin", - "60mg Enoxaparin", - "Control" - ], - "diseases": "['Obesity']", - "diseases_list": [ - "Obesity" - ], - "enrollment": "55.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult patient undergoing laparoscopic sleeve gastrectomy. \n\n The patient undergoes the surgery in the surgical wing of the Tel-Aviv Sourasky Medical Center. \n\n The patient has received full information regarding the studies nature, has agreed to participate and has given informed consent (documented by a signed informed consent form). \n\n ", - "exclusion_criteria": ": \n\n Patients with a previous Venous Thromboembolic Event. \n\n Patients requiring an IVC filter. \n\n Patients with known thrombophilia due to coagulation factor disorders (i.e factor V leiden). \n\n Patients with a bleeding disorder \n\n Patients with renal failure.", - "brief_summary": "Approximately two thirds of the adult population in developed countries is categorized as over-weight or obese (BMI>30). In spite of worldwide increasing awareness, obesity is a major health concern. In the presence of numerous diets, medical therapies, and robust research, bariatric surgery remains the most effective means of weight reduction in morbidly obese patients (BMI>40, or BMI>35 with co-morbidities). However, bariatric surgery harbors a relatively high risk for postoperative complications; of them, venous thromboembolic events (VTE) are not common, but potentially lethal. Taken together with the propensity of morbidly obese patients to develop VTE, perioperative thromboprophylaxis is mandatory.~To date, low molecular weight heparins (LMWH) are most commonly used for VTE prophylaxis in the aforementioned population. Due to the pharmacologic properties of LMWH and the characteristics of surgically treated obese patients, the optimal dose that is to be utilized for VTE prophylaxis in this population remains unclear. Assessment of anti-FXa levels in the patients' plasma can be used in order to monitor LMWH activity. Levels of 0.2-0.5 U/ml have been proposed by some authors for VTE prophylaxis.~Few studies have compared different dosing regimens of enoxaparin (between 30mg-60mg q/12h) for VTE prophylaxis in the population undergoing bariatric surgery; nevertheless, these were small non- randomized trials, containing numerous methodological weaknesses. Hence, the optimal regimen of enoxaparin to be used for the prevention of VTE in the discussed population remains unclear.~The aim of the present study is to evaluate plasma levels of anti-FXa activity, comparing two most commonly used enoxaparin prophylactic regimens (40mg vs 60mg q/24h) in a large and homogenous cohort of sleeve gastrectomy patients. Although universally used by bariatric surgeons, the pharmacologic efficacy of these regimens has not been evaluated in patients undergoing bariatric surgery.", - "NCTID": "NCT01970202" - }, - { - "brief_title": "Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery", - "phase": "Phase 2", - "drugs": "['TB-402', 'Rivaroxaban', 'TB-402']", - "drugs_list": [ - "TB-402", - "Rivaroxaban", - "TB-402" - ], - "diseases": "['Prophylaxis of Venous Thromboembolic Events']", - "diseases_list": [ - "Prophylaxis of Venous Thromboembolic Events" - ], - "enrollment": "632.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female subjects aged \u2265 18 years. \n\n Written informed consent. \n\n Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures \n\n ", - "exclusion_criteria": ": \n\n Pregnancy at the time of screening. \n\n Indication for anticoagulation other than post-operative thromboprophylaxis. \n\n Active bleeding or high risk of bleeding. \n\n Anticipated continued use of neuraxial catheter after surgery. \n\n Clinical laboratory findings at screening of thrombocytopenia or prolonged aPTT or PT. \n\n Uncontrolled hypertension. \n\n Impaired liver function (transaminase >3 X ULN) or history of hepatic insufficiency. \n\n Creatinine clearance <30 mL/min. \n\n Antiplatelet agents other than low dose aspirin (< 200mg). \n\n The use of intermittent pneumatic compression. \n\n Known hypersensitivity to contrast media or rivaroxaban. \n\n Known drug or alcohol abuse. \n\n Active malignant disease or current cytostatic treatment. \n\n Stroke within the previous month. \n\n Participation in an investigational drug study within the past 30 days or previous participation in this study. \n\n Any condition that in the opinion of the investigator would put the subject at increased risk from participating in the study or expected inability to comply with the protocol.", - "brief_summary": "The purpose of this study is to evaluate the safety and efficacy of two doses of TB-402 administered as a single intravenous infusion for the prevention of VTE in subjects undergoing total hip replacement surgery.", - "NCTID": "NCT01344954" - }, - { - "brief_title": "Frequency of Vascular Events With Short-term Thromboprophylaxis in Fast-track Hip and Knee-arthroplasty.", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Thromboembolic Events', 'Post-operative Bleeding']", - "diseases_list": [ - "Thromboembolic Events", - "Post-operative Bleeding" - ], - "enrollment": "4924.0", - "inclusion_criteria": "inclusion criteria: \n\n primary Uni/bilateral THR/TKR, revision THR/TKR or uni-KR in fast-track setup, Discharged in 3 +-2 days. \n\n ", - "exclusion_criteria": ": \n\n not a danish citizen", - "brief_summary": "There are many different views regarding ideal duration and type of thromboprophylaxis after hip or knee surgery.~An important factor in Fast-track surgery is early mobilization, which in itself is thought to prevent clotting.~The investigators hypothesize that there is no increase with regards to thrombosis in patients receiving fast-track surgery with early mobilization and chemical thrombosis prophylaxis only during hospitalization.", - "NCTID": "NCT01557725" - }, - { - "brief_title": "Standard Therapy With or Without Dalteparin in Treating Patients With Advanced Breast, Lung, Colorectal, or Prostate Cancer", - "phase": "Phase 3", - "drugs": "['dalteparin', 'standard therapy']", - "drugs_list": [ - "dalteparin", - "standard therapy" - ], - "diseases": "['Breast Cancer', 'Colorectal Cancer', 'Lung Cancer', 'Prostate Cancer', 'Veno-occlusive Disease']", - "diseases_list": [ - "Breast Cancer", - "Colorectal Cancer", - "Lung Cancer", - "Prostate Cancer", - "Veno-occlusive Disease" - ], - "enrollment": "141.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: Histologically or cytologically proven breast, lung, colorectal, or prostate cancer that has failed prior chemotherapy or hormone therapy No active CNS metastases Hormone receptor status: Not specified \n\n PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3500/mm3 Platelet count at least 150,000/mm3 Fibrinogen above lower limits of normal Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Prothrombin time no greater than 1.5 times ULN Active partial thromboplastin time no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: No history of heparin associated thrombocytopenia At least 1 year since prior thromboembolic phenomenon such as deep venous thrombosis, pulmonary embolus, or clotted catheter No prior intolerance of unfractionated or low molecular weight heparin \n\n PRIOR CONCURRENT THERAPY: No concurrent anticoagulation therapy No concurrent enrollment on systemic or radiation therapy study (therapy off study allowed)", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Dalteparin may be effective in inhibiting the growth of blood vessels in tumors, decreasing the risk of metastatic cancer, preventing the formation of blood clots, and improving quality of life in treating patients with advanced cancer that has not responded to previous treatment. It is not yet known if standard therapy is more effective with or without dalteparin in treating advanced breast, lung, colorectal, and prostate cancer.~PURPOSE: Randomized double blinded phase III trial to compare the effectiveness of standard therapy with or without dalteparin in treating patients who have advanced breast, lung, colorectal, or prostate cancer that has not responded to previous chemotherapy or hormone therapy.", - "NCTID": "NCT00003674" - }, - { - "brief_title": "Randomized Controlled Trial (RCT) in Children With Severe Pneumonia", - "phase": "", - "drugs": "['Day-care treatment vs. hospital care']", - "drugs_list": [ - "Day-care treatment vs. hospital care" - ], - "diseases": "['Severe Pneumonia']", - "diseases_list": [ - "Severe Pneumonia" - ], - "enrollment": "368.0", - "inclusion_criteria": "inclusion criteria: \n\n Age: 2 to 59 months \n\n Sex: Both boys and girls \n\n Severe pneumonia according to WHO criteria (Severe pneumonia is defined as cough or difficult breathing with lower chest wall in drawing with or without fast breathing which is defined as the respiratory rate \u2265 50 breaths per minute for children aged 2-11 months and \u2265 40 breaths per minute for children aged 12-59 months) \n\n Attend the Radda Clinic and ICHSH between 8:00 am to 4:00 pm (Sunday through Saturday) \n\n Written informed consent by respective parents/guardians \n\n ", - "exclusion_criteria": ": \n\n Very severe and non-severe pneumonia \n\n Nosocomial pneumonia \n\n History of taking antibiotics for pneumonia within 48 hour prior to enrollment \n\n Chronic illnesses like tuberculosis, cystic fibrosis \n\n Congenital deformities/anomalies e.g. Down's Syndrome, congenital heart disease \n\n Immunodeficiency \n\n Trauma/burn \n\n Bronchiolitis \n\n Bronchial asthma \n\n Lives far away from the Radda Clinic and ICHSH (outside 5 km radius from the respective study site) \n\n Parents/guardians not consenting for inclusion of their children in the study", - "brief_summary": "Pneumonia is the leading cause of childhood morbidity and death in many developing countries including Bangladesh, causing about 2 million deaths worldwide each year. Pneumonia is an infection of the lungs, most commonly caused by viruses or bacteria like Streptococcus pneumoniae and Haemophilus influenzae. Depending on the clinical presentation, pneumonia can be classified as very severe, severe or non-severe, with specific treatment for each of them except for antibiotic therapy. Severe and very severe pneumonia require hospitalization for additional supportive treatment such as suction, oxygen therapy and administration of bronchodilator. In Bangladesh, the number of hospital beds is inadequate for admission of all pneumonia cases that require hospitalization; however, it is also important to provide institutional care to those children who cannot be hospitalized due to bed constraints. Provision of appropriate antibiotics and supportive cares during the period of stay at established day-care centres could be an effective alternative. The impetus for this study came from the findings of our recently completed study titled Daycare-based management of severe pneumonia in under-5 children when hospitalization is not possible due to the lack of beds. This study successfully managed children (n=251), but it was not a randomized trial and thus direct comparison of the efficacy of management of severe pneumonia at the day-care centre, essential for building confidence for implementing this management policy, is not possible. We, the researchers at the International Centre for Diarrhoeal Disease Research, Bangladesh, could not plan a randomized, controlled trial (RCT) because of ethical reasons. Now that we have data suggesting effectiveness as well as safety of the day-care based treatment for management of children with severe pneumonia, a RCT should be possible. Two hundred fifty-one children with severe pneumonia were enrolled at the Radda Clinic from June 2003 to May 2005. The mean age was 7\u00b17 (2-55) months, 86% infants, 63% boys and 91% breast-fed. History of cough was present in 99% cases, fever in 89% and rapid breathing in 67% cases. Forty-four percent of children were febrile (\u226538\u00b0C), 93% children had vesicular breath sound and 99% bilateral rales. Fifty-seven percent of children were hypoxic with mean oxygen saturation of (93\u00b14)%, which was corrected by oxygen therapy (98\u00b13)%. Eighty percent of children had severe pneumonia and 20% had very severe pneumonia. The mean duration of clinic stay was (7\u00b12) days. Two hundred thirty-four (93%) children completed the study successfully, 11 (4.4%) referred to hospitals (only one participant had to visit hospital at night due to deterioration of his condition, 9 were referred to hospital at the time of clinic closure i.e., at 5 pm and one participant was referred to hospital during the morning hours) and 6 (2.4%) left against medical advice (LAMA). There was no death during the period of clinic stay but only four (1.6%) deaths occurred during the 3 months follow-up. The study indicated that treatment of severe pneumonia in children at the day-care centre is effective and safe and thus it is comparable to the hospital care. If the day-care based management is found to have comparable efficacy to that of hospitalized management of severe pneumonia in children then they could be managed at outpatient, day-care set ups reducing hospitalization and thus freeing beds for management of other children who need hospitalized care. Additionally, availability of the treatment facility in community set-ups will be cost and time saving for the population. Children of either sex, aged 2-59 months, attending the Radda Clinic and Institute of Child Health and Shishu Hospital (ICHSH) with severe pneumonia will be randomized to receive either the day-care management at the clinic or hospitalized management at the ICHSH. Children randomized to receive day-care treatment will stay at the clinic from 8 am-5 pm and will receive antibiotics and other supportive cares. At 5 pm, they would be send to respective homes with advice to bring back their children to the clinic next morning, and advised to provide other supports at home. The same management would be continued till improvement and discharged and followed up every 2 weeks for 3 months. Children randomized to receive hospitalized management would be admitted at ICHSH and receive standard treatment like antibiotics and other supportive cares. The same treatment would be continued for 24 hours/day (rather than 9 hours/day at the day-care clinic) till improvement and discharged and followed-up at the ICHSH every 2 weeks for 3 months. About 3000 children with pneumonia visit Radda Clinic each year and about 200 of them will have severe pneumonia requiring hospitalization. Thus, we hope to enroll 368 (184 in each site) children with severe pneumonia during a 2-year study period.", - "NCTID": "NCT00455468" - }, - { - "brief_title": "The HIT-TRAP Trial", - "phase": "Phase 4", - "drugs": "['Standard heparin (UFH) versus certoparin (LMWH)']", - "drugs_list": [ - "Standard heparin (UFH) versus certoparin (LMWH)" - ], - "diseases": "['Heparin-Induced Thrombocytopenia']", - "diseases_list": [ - "Heparin-Induced Thrombocytopenia" - ], - "enrollment": "600.0", - "inclusion_criteria": "inclusion criteria: \n\n trauma-surgical patient \n\n consent given \n\n minimum age 18 \n\n expected inpatient period at least 7 days \n\n need for thrombosis prophylaxis with heparin \n\n ", - "exclusion_criteria": ": \n\n intolerance of one of the study drugs \n\n malignancy with life expectancy < 3 months \n\n pregnancy/lactation \n\n drug or alcohol abuse \n\n fibrinolytic therapy \n\n need for extracorporal circulation (e.g. cardiopulm. bypass, hemodialysis) at study entry \n\n participation in another clinical trial within 30 days prior to intended inclusion", - "brief_summary": "Randomised, double blind trial in non-intensive care trauma patients comparing unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH) in heparin-induced thrombocytopenia (HIT).", - "NCTID": "NCT00196417" - }, - { - "brief_title": "Measurements of Doppler Signals Noninvasively From the Lung in Congestive Heart Failure", - "phase": "", - "drugs": "['Transchoracic ultrasound Doppler']", - "drugs_list": [ - "Transchoracic ultrasound Doppler" - ], - "diseases": "['Pulmonary Edema']", - "diseases_list": [ - "Pulmonary Edema" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Age over 18 years \n\n Belongs to one of the following categories: \n\n A. Acute decompensated left HF: patients with acute pulmonary congestion or pulmonary edema diagnosed on the basis of all of the following criteria: \n\n Dyspnea at rest or with minimal activity \n\n Rales on auscultation \n\n Evidence of pulmonary congestion or edema on chest X-ray. \n\n BNP level >400 pg/ml \n\n B. Compensated left HF: patients with significant stable left HF (NYHA II-III) who are on optimal medical treatment for CHF, and are without clinical or laboratory evidence of pulmonary congestion. The following 3 criteria must be met: \n\n No dyspnea at rest \n\n No rales on auscultation \n\n BNP levels < 100 pg/ml \n\n C. Non-CHF controls: patients without CHF and without uncontrolled hypertension. \n\n 3 Signed Informed Consent \n\n ", - "exclusion_criteria": ": \n\n - Decompensated left HF subgroup & Non CHF controls \n\n Pneumonia- currently or in the past 1 month prior to inclusion \n\n Non-cardiogenic pulmonary edema or lung injury (e.g. ARDS) \n\n Interstitial lung disease \n\n Severe kyphosis, scoliosis or chest wall deformity \n\n Pregnant women \n\n Compensated left HF subgroup \n\n Chronic obstructive pulmonary disease (COPD) \n\n Asthma \n\n Interstitial lung disease \n\n Any other obstructive or restrictive lung diseases \n\n Pneumonia- currently or in the past 3 months prior to inclusion \n\n Non-cardiogenic pulmonary edema or lung injury (e.g. ARDS) \n\n Current or past pulmonary embolism \n\n Large right sided pleural effusion \n\n Severe kyphosis, scoliosis or chest wall deformity \n\n Pregnant woman", - "brief_summary": "The purpose of this study is to evaluate the lung Doppler signals in left HF patients with and without pulmonary congestion (i.e. decompensated left HF patients and compensated left HF patients respectively), in comparison to a control group of subjects without CHF (non-CHF controls), in order to determine the diagnostic value of this non-invasive method in CHF. If this method will prove to be of diagnostic value, it could potentially be used to diagnose and monitor CHF patients in both inpatient and outpatient settings.", - "NCTID": "NCT01940328" - }, - { - "brief_title": "The Effects of Sound Energy on Pulmonary Gas Exchange", - "phase": "", - "drugs": "['Induction of sound waves in lungs by sonic oscillator']", - "drugs_list": [ - "Induction of sound waves in lungs by sonic oscillator" - ], - "diseases": "['Respiratory Failure']", - "diseases_list": [ - "Respiratory Failure" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy male or female volunteers in the age group. \n\n ", - "exclusion_criteria": ": \n\n Any acute or chronic cardiopulmonary disorder including a simple common cold.", - "brief_summary": "Study of the effects of sonic pressure oscillations on pulmonary gas exchange with added dead space.", - "NCTID": "NCT02447731" - }, - { - "brief_title": "Multimodal DVT Protocol in Tourniquet-less Total Knee Arthroplasty", - "phase": "", - "drugs": "['extended compression', 'Aspirin']", - "drugs_list": [ - "extended compression", - "Aspirin" - ], - "diseases": "['Deep Vein Thrombosis']", - "diseases_list": [ - "Deep Vein Thrombosis" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n TKA candidacy, osteoarthritis, patients able to understand study intent, and agree to study participation \n\n ", - "exclusion_criteria": ": \n\n Subjects with personal or family history of DVT, currently taking antiplatelet/anticoagulant drugs, genetic risk factor positive for VTE, pronounced thrombocytopenia, GI bleed within 6 months of surgery, NSAID intolerance, orthopaedic and medical co-morbidities that would prevent postoperative rapid mobilization and compliance with MCD such as extra-articular pathology with referred pain to the knee (spinal stenosis, neuropathy, ipsilateral hip disease), severe knee deformity, post-traumatic and inflammatory arthritis, BMI above 40, active knee sepsis, remote sites of active infection, ASA class > lll, cardiac disease failing medical clearance, severe liver disease, peripheral artery disease, seizure disorder, alcohol abuse, smoking abuse", - "brief_summary": "The Cothera VPulse(tm) mechanical compression device (MCD) combines rapid intermittent sequential compression with cold therapy and is designed for single patient use in the home. Additionally, it can track patient compliance. This study will examine if there is a difference in deep vein thrombosis (DVT) occurrence over 3 weeks after tourniquet-less total knee arthroplasty (TKA) and multimodal prophylaxis with or without extended MCD use in a cooling device/MCD system.", - "NCTID": "NCT02102828" - }, - { - "brief_title": "Evaluation of the LMWH Thromboprophylaxis in Pregnancy", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pregnancy']", - "diseases_list": [ - "Pregnancy" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n pregnant women undergoing planned caesarean section \n\n 39th-40th week of pregnancy \n\n age 18-40 years \n\n ", - "exclusion_criteria": ": \n\n disapproval or non-cooperation of the mother \n\n allergy to LMWH \n\n coagulation disorders or the risk of \n\n anticoagulant therapy in the last 3 months \n\n signs of infection \n\n history of cancer \n\n signs of thrombosis or a history of thrombosis \n\n the ongoing non-physiological pregnancy \n\n significant obesity, or other severe comorbidity", - "brief_summary": "The project aims to clarify the effect of the thromboprophylactic LMWH dose on coagulation in pregnant women just before birth, at the period of maximal physiological hypercoagulable state and with high risk of thromboembolism, the most common cause of maternal mortality in developed countries. Although LMWH are now routinely administered as prevention of thromboembolism, their effect on coagulation in pregnant women was not yet studied. The doses of LMWH in pregnancy are only derived in terms of coagulation from totally different groups of patients (surgical, orthopedic). We therefore will map the effect of thromboprophylactic LMWH dose on coagulation in pregnant women using recently available methods, especially a complex examination of coagulation within 24 h after LMWH application using thrombelastography, including examination with heparinase, and monitoring the effect of LMWH by measuring antiXa and TGT (thrombin generation time) activity. Based on these results we will also evaluate the possible influence of LMWH prophylaxis on the risk of spinal haematoma during neuraxial analgesia/anesthesia for delivery/Caesarean section. On the basis of our pilot results we can presume the current dosage of LMWH in pregnant women is inadequate and that it would be appropriate to adjust presently used dosage. At the same time we want to prove that the standard LMWH thromboprophylaxis in pregnant women does not increase the risk of spinal haematoma during neuraxial blockade. In both situations the targeted outcome is to increase the safety of pregnant women.", - "NCTID": "NCT01394107" - }, - { - "brief_title": "The Effect of Fenoldopam in Solitary Partial Nephrectomy Surgery", - "phase": "", - "drugs": "['Fenoldopam', 'Placebo']", - "drugs_list": [ - "Fenoldopam", - "Placebo" - ], - "diseases": "['Partial Nephrectomy']", - "diseases_list": [ - "Partial Nephrectomy" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who have a solitary kidney and present for a partial nephrectomy \n\n Patients who have one atrophic minimally functioning kidney and present for partial nephrectomy on the other kidney \n\n ", - "exclusion_criteria": ": \n\n History of current renal disease beyond the diagnosis of renal malignancy \n\n Insulin dependent diabetes mellitus, myocardial infarction without subsequent coronary artery bypass or angioplasty \n\n History of congestive heart failure, renovascular occlusion greater than 45 minutes or less than 15 minutes, greater than one half of the solitary kidney resected \n\n A major perioperative complication that would potentially affect postoperative renal function (myocardial infarction, congestive heart failure, pulmonary embolus, massive hemorrhage and hypotension, ureteral obstruction or vascular thrombosis), and evidence of nephrotoxicity due to antibiotics", - "brief_summary": "This trial will study the effects of fenoldopam on renal function in patients who have a single kidney undergoing surgery to remove part of that kidney secondary to renal cell carcinoma. The investigators will monitor and evaluate throughout the perioperative course the kidney function. Normally kidney function is predicted to show a worsening followed by an improvement after surgery.~The investigators want to specifically identify if the use of fenoldopam lessens the injury to the kidney with this surgery.", - "NCTID": "NCT00743106" - }, - { - "brief_title": "Alterations of the Uteroplacental and Fetal Pulmonary Circulation Following Amnioinfusion", - "phase": "Phase 1", - "drugs": "['amnioinfusion procedure']", - "drugs_list": [ - "amnioinfusion procedure" - ], - "diseases": "['Severe Oligohydramnios']", - "diseases_list": [ - "Severe Oligohydramnios" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients above 18 years, who are able to consent; \n\n Singleton pregnancy; \n\n Normal structural examination between 16 and 20 weeks of gestation; \n\n Gestation between 18 and 34 weeks (the pregnancy duration determined by ultrasound verification within the 20th week); \n\n At least two US examinations at the presentation for confirmation and for the diagnosis of persistent oligohydramnios; \n\n Follow up ultrasound examinations weekly in both groups. \n\n ", - "exclusion_criteria": ": \n\n 1. pPROM; 2. Fetal structural anomaly detected at prenatal ultrasonography, or fetal chromosomal abnormalities involving autosomes; 3. Symptoms referring incomplete abortion before 24 weeks of gestation; 4. Maternal contraindications to intervention or prolongation of pregnancy, including severe medical conditions in pregnancy that make the intervention riskful; 5. No active premature labor (shortened cervix <15 mm, <3 cm of cervical dilatation; >6/hour uterine contractions) after 24 weeks of gestation; 6. Cervical cerclage in place; 7. Clear signs of maternal or fetal infection (2 or more of the following: maternal tachycardia >100/min, maternal temperature >38\u00b0C, maternal white blood count cells (WBC) >15,000/ml, maternal C-reactive protein (CRP) >20 mg/l, uterine tenderness, foul-smelling vaginal discharge, fetal tachycardia >160 bpm); 8. Suspicion of placental abruption (uterine tenderness and bleeding episodes); 9. Previous invasive procedure in the pregnancy; 10. Fetal condition mandating immediate delivery; 11. Severe bleeding at present; 12. Maternal HIV and HBV/HCV infection; 13. Multiple gestation. \n\n -", - "brief_summary": "The aim of this study is to compare the uteroplacental and pulmonary circulation of the fetuses with severe (AFI<5cm) idiopathic oligohydramnios (with unknown origin) to those in normal controls. Further purpose of the study is to measure the changes of the uteroplacental and fetal pulmonary circulation in patients presenting with severe idiopathic oligohydramnios, managed either with single amnioinfusion or with serial amnioinfusions.", - "NCTID": "NCT01258725" - }, - { - "brief_title": "Use of Nesiritide in the Management of Acute Diastolic Heart Failure", - "phase": "Phase 4", - "drugs": "['Nesiritide']", - "drugs_list": [ - "Nesiritide" - ], - "diseases": "['Heart Failure', 'Cardiovascular Disease', 'Acute Heart Failure', 'Diastolic Heart Failure', 'Congestive Heart Failure', 'Heart Disease']", - "diseases_list": [ - "Heart Failure", - "Cardiovascular Disease", - "Acute Heart Failure", - "Diastolic Heart Failure", - "Congestive Heart Failure", - "Heart Disease" - ], - "enrollment": "9.0", - "inclusion_criteria": "The patient population recruited for this study will include patients being admitted for acute congestive heart failure. Eligible patients include those who have near normal LV systolic function. \n\n inclusion criteria: \n\n Age 18 to 85 years old \n\n Admitted with acute heart failure determined by: symptoms of fatigue; shortness of breath; edema; physical evidence of volume overload; and/or pulmonary edema by CXR \n\n LVEF > or = 40% on recent (< or = 1 month) echo or MUGA \n\n NYHA class III or IV on admission \n\n Baseline systolic blood pressure > 90 mm Hg \n\n Baseline BNP level > 100 pg/ml \n\n Able to sign informed consent and return for follow-up assessments \n\n ", - "exclusion_criteria": ": \n\n Patients with clinically significant hypotension (defined as a systolic blood pressure (SBP) <90 mm Hg) \n\n Active infection/sepsis as defined by fever > 101.5 F, currently on IV antibiotics \n\n Creatinine greater than 3.0 mg/dl \n\n LV ejection fraction < 40% (must be done within the last 30 days prior to signing consent) \n\n Significant valvular disease or constrictive cardiomyopathy \n\n Severe Thrombocytopenia (as defined by platelets less than 20,000) or INR > 1.6 \n\n Hypersensitivity to nesiritide or any of its components. \n\n Pulmonary capillary wedge pressure (PCWP) <16 mmHg \n\n If patient is of child-bearing age, a pregnancy test will be performed, and the patient is excluded if pregnancy test is positive.", - "brief_summary": "Primary objective is to assess the effect of nesiritide in decreasing left ventricular (LV) filling pressure, defined as pulmonary artery capillary wedge pressure (PCWP) in a group of patients admitted with acute diastolic heart failure.~Secondary objectives include: improvement in symptoms, exercise tolerance, improvement in Doppler diastolic filling parameters in patients with diastolic heart failure.", - "NCTID": "NCT00083772" - }, - { - "brief_title": "Reperfusion of Pulmonary Arteriovenous Malformations After Embolotherapy", - "phase": "", - "drugs": "['Angiography and embolotherapy']", - "drugs_list": [ - "Angiography and embolotherapy" - ], - "diseases": "['Pulmonary Arteriovenous Malformations']", - "diseases_list": [ - "Pulmonary Arteriovenous Malformations" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients are eligible for inclusion in the study if all the following criteria are met: \n\n Documented presence of new (untreated) pulmonary AVMs requiring embolization \n\n Definite clinical diagnosis of HHT or genetic diagnosis of HHT \n\n Age \u226518 years \n\n Able to provide informed consent \n\n ", - "exclusion_criteria": ": \n\n Patients will be excluded from the study if, in the opinion or knowledge of the Principal Investigator any of the following criterion is present: \n\n Participants with multiple AVMs within close proximity where identification of the aneurysm seen on CT cannot be precisely isolated for randomization purposes. \n\n Contra-indications to embolotherapy \n\n Severe chronic renal failure, without availability of dialysis \n\n Severe pulmonary hypertension (PA systolic estimated at >60mmHg)", - "brief_summary": "AVMs are abnormal collections of blood vessels which can occur in any part of the body including the lungs. These blood vessels are weakened and can rupture anytime causing bleeding which can be massive, leading to life-threatening conditions.~Pulmonary AVMs occur in about 40% of patients with HHT. Each patient may have an average of 5 AVMs .Rupture of the AVM can lead to massive bleeding in the lung, stroke and infection of the brain. In order to prevent these complications, patients with HHT are routinely examined for pulmonary AVMs and treatment with embolization is recommended.~AVMs have a main blood vessel or artery supplying blood to the collection of blood vessels. The way to treat AVMs is cut off their blood supply through a process called embolization.~Embolization is a standard medical procedure which is done to stop or prevent hemorrhage (bleeding) from an AVM. It involves blocking the artery that supplies blood to the AVM by inserting a foreign body, into the blood vessel supplying blood to the AVM.~Standard devices used for embolization include coils (made of stainless steel or platinum). These devices usually have a good success rate for blocking the artery that supplies blood to the AVM. However, a few AVMs that are embolized by standard devices may reopen over time. This is called reperfusion and will require repeat embolization procedures.~For embolization of pulmonary AVMs at St. Michael's Hospital, the Nester coil is used. In this study, we would like to compare the Nester coil with a new coil device called the Interlock Fibered IDC Occlusion System. Both coils are approved for use in Canada, however the cost of the IDC coil limits its use at this hospital.~Compared to the Nester coil, the IDC coils are made so that they can be removed or repositioned if they are not placed correctly. The coil also allows tighter packing which helps prevent reperfusion.~This study will compare the success rate of embolization between the Interlock\u2122 Fibered IDC\u2122 Occlusion System (IDC coil) and the Nester coil.", - "NCTID": "NCT01856842" - }, - { - "brief_title": "The Visualization of Uncertainty in Clinical Diagnostic Reasoning for Pulmonary Embolism", - "phase": "", - "drugs": "['Visualized pulmonary embolism computer task model', 'Didactic review lecture']", - "drugs_list": [ - "Visualized pulmonary embolism computer task model", - "Didactic review lecture" - ], - "diseases": "['Pulmonary Embolism', 'Diagnostic Uncertainty', 'Clinical Reasoning', 'Evidence Based Medicine', 'Visualization of Uncertainty']", - "diseases_list": [ - "Pulmonary Embolism", - "Diagnostic Uncertainty", - "Clinical Reasoning", - "Evidence Based Medicine", - "Visualization of Uncertainty" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Medical students, University of Calgary, in clerkship who finished at least 4 weeks of a block of medicine rotation at any hospital site. \n\n First year subspecialty or Internal Medicine residents. \n\n Practicing physicians in the subspecialties of Internal Medicine or Emergency Medicine. \n\n ", - "exclusion_criteria": ": \n\n Physicians in the subspecialty of Haematology or Respiratory", - "brief_summary": "Medical reasoning is a form of inquiry that examines the thought processes involved in making medical decisions. When physicians are faced with patients' symptoms or signs, their thought processes follow either direct shortcuts to suspect a diagnosis or go into a deeper and more analytic process to reach a diagnosis. The second pathway is less prone to biases and errors. This study explores whether the use of an interactive visual display of probabilities of pulmonary embolism generated from positive or negative test results will increase the adherence to evidence based guidelines in the diagnosis of pulmonary embolism.", - "NCTID": "NCT01752673" - } - ], - "1": [ - { - "brief_title": "Long-term Treatment for Cancer Patients With Deep Venous Thrombosis or Pulmonary Embolism", - "phase": "Phase 3", - "drugs": "['low molecular weight heparin', 'vitamin K antagonists']", - "drugs_list": [ - "low molecular weight heparin", - "vitamin K antagonists" - ], - "diseases": "['Venous Thromboembolism', 'Neoplasms']", - "diseases_list": [ - "Venous Thromboembolism", - "Neoplasms" - ], - "enrollment": "56.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with cancer and confirmed pulmonary embolism (PE) or deep vein thrombosis (DVT) of the leg who have been treated for minimally 6 and maximally 12 months with therapeutic doses of anticoagulants, i.e. LMWH or VKA or a new anticoagulant in a trial \n\n Written informed consent \n\n Indication for long-term anticoagulant therapy (e.g. because of metastasized disease, chemotherapy) \n\n ", - "exclusion_criteria": ": \n\n Legal age limitations (country specific), minimum age at least 18 years \n\n Indications for anticoagulant therapy other than DVT or PE \n\n Any contraindication listed in the local labeling of LMWH or VKA \n\n Childbearing potential without proper contraceptive measures, pregnancy or breastfeeding \n\n Life expectancy <3 months", - "brief_summary": "Background~Patients with cancer and a first deep venous thrombosis of the leg or pulmonary embolism (venous thromboembolism, VTE) are generally treated with low molecular weight heparin (LMWH)injections for 6 months, since this treatment is associated with a reduced incidence of recurrent VTE compared to vitamin K antagonists (VKA). It is recommended that patients with active malignancy (metastatic cancer and/or ongoing cancer treatment)continue anticoagulant treatment. However, it is unknown whether LMWH is still superior compared to VKA for the long-term anticoagulant treatment.~Aim~The aim of this study is to evaluate whether low-molecular-weight heparin more effectively reduces recurrent VTE compared to vitamin K antagonists in patients with cancer who have already completed 6 to 12 months of anticoagulant treatment because of deep venous thrombosis of the leg or pulmonary embolism.~Hypothesis~The investigators hypothesize that LMWH is more effective compared to VKA in the long-term treatment of VTE in cancer patients who have already been treated for 6-12 months with anticoagulants.~Design~This is a multicenter, multinational, randomized, open label trial.~Patients~Patients with a malignancy (all types, solid and hematological) who have received 6-12 months of anticoagulation for VTE and have an indication for continuing anticoagulation, will be randomly assigned to six additional months of LMWH or VKA. LMWH will be administered in a weight-adjusted scheme, with 65-75% of therapeutic doses. All types of LMWH and VKA are allowed, as long as weight adjusted dosing is possible for LMWH. The target INR will be 2.0-3.0. The primary efficacy outcome is symptomatic recurrent VTE, i.e. deep vein thrombosis and pulmonary embolism. The primary safety outcome is major bleeding.~Sample size~A total of 65 to 87 recurrent VTE events are needed to show a 50% reduction with LMWH as compared to VKA (type I error 0.05, two-sided, power respectively 80 and 90%). To observe 75 events, with a 10% event rate per half year in the VKA arm and 5% in the LMWH arm a total of 1000 patients will need to be included.~Organisation~Outcomes will be adjudicated by a central adjudication committee. A steering committee will be formed, preferably consisting of one member of every participating center. An electronic case report form will be used for data collection. Also, an electronic trial master file will be used.", - "NCTID": "NCT01164046" - }, - { - "brief_title": "Epidemiology of Venous Thromboembolism", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Venous Thromboembolism', 'Pulmonary Embolism', 'Cancer', 'Deep Vein Thrombosis', 'COPD']", - "diseases_list": [ - "Venous Thromboembolism", - "Pulmonary Embolism", - "Cancer", - "Deep Vein Thrombosis", - "COPD" - ], - "enrollment": "5451.0", - "inclusion_criteria": "inclusion criteria: \n\n Ultrasound-confirmed DVT patients from 183 institutions.", - "exclusion_criteria": "", - "brief_summary": "More than 5 years ago the DVT FREE Registry was conceived. Its database consists of 5,451 ultrasound-confirmed DVT patients from 183 institutions. This database is rich in information of critical importance to health care providers. The information contained within the database will be revisited to provide more detailed analyses which will be used for risk factor assessment and for decision-making regarding the implementation of VTE Prophylaxis.", - "NCTID": "NCT00456196" - }, - { - "brief_title": "BNP Testing in Patients With SOB on Presentation to ED", - "phase": "Phase 1", - "drugs": "['BNP test']", - "drugs_list": [ - "BNP test" - ], - "diseases": "['Heart Failure, Congestive']", - "diseases_list": [ - "Heart Failure", - "Congestive" - ], - "enrollment": "600.0", - "inclusion_criteria": "inclusion criteria: \n\n We plan to include all patients presenting to the ED with shortness of breath that are over 40 years old and present with an emergency department triage category of 3 or higher. \n\n ", - "exclusion_criteria": ": \n\n Patients presenting with a traumatic cause of dyspnea, patients with severe renal disease (serum creatinine level of more than 250 micro mmol/L, patients with cardiogenic shock, and patients who have an early transfer to another hospital (within 24 hrs) will be excluded.", - "brief_summary": "A trial to examine whether a new heart failure blood test can improve the outcome of patients presenting to the Emergency Department with shortness of breath.~We hypothesise that a BNP test performed in real-time in patients presenting to the Emergency Department with shortness of breath will help identify additional patients with CHF and consequently to change practice and allow more patients to recieve correct treatment earlier.", - "NCTID": "NCT00163709" - }, - { - "brief_title": "Innohep\u00ae in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis", - "phase": "Phase 4", - "drugs": "['innohep\u00ae', 'Heparin']", - "drugs_list": [ - "innohep\u00ae", - "Heparin" - ], - "diseases": "['Deep Vein Thrombosis']", - "diseases_list": [ - "Deep Vein Thrombosis" - ], - "enrollment": "541.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with a symptomatic and objectively confirmed Venous Thromboembolism (VTE) (lower limb deep venous thrombosis (DVT) or pulmonary embolus (PE)) with mandatory presences of objectively confirmed and treatment requiring DVT, i.e. symptomatic and objectively confirmed distal DVT or objectively confirmed, symptomatic or asymptomatic proximal DVT (confirmation of DVT should be performed by ultrasonography or venography within 48 hous prior to randomisation) \n\n Patients with an indication for DVT treatment with SC Low Molecular Weight Heparin (LMWH) or Unfractionated Heparin (UFH) followed by Oral Anticoagulant (OAC) for at least 90 days \n\n Hospitalized patients who, during SC anticoagulant treatment, will be followed, as specified in the protocol, on a daily basis either in the hospital or in an out-patient setting \n\n Patients at or above 75 years with a creatinine clearance less than or equal to 60 mL/min calculated according to the Cockcroft-Gault formula \n\n Patients at or above 70 years with a creatinine clearance less than or equal to 30 mL/min calculated according to the Cockcroft-Gault formula \n\n ", - "exclusion_criteria": ": \n\n Patients receiving high dose (i.e. equivalent to a dose recommended for treatment of DVT) of UFH or LMWH or thrombolytic agents within the last 4 weeks except for UFH/LMWH during the last 36 hours prior to randomisation \n\n Patients on oral anticoagulant treatment (vitamin K-antagonists) at or within last 1 week prior to randomisation \n\n Patients with a symptomatic venous thromboembolism (VTE) requiring thrombolytic therapy or invasive intervention \n\n End stage renal disease patients requiring dialysis \n\n Surgery within 2 weeks prior to randomisation or planned surgery, epidural anaesthesia and/or spinal anaesthesia during the SC anticoagulant treatment period \n\n Planned use of acetylsalicylic acid in doses above 300 mg/day, NSAID or Dextran 40 at randomisation and during the SC anticoagulant treatment period \n\n Patients with a current overt bleeding or known haemorrhage condition (e.g. active G.I. ulcer) \n\n Patients with a platelet count < 100 x 10 9/L \n\n Patients with a known history of heparin-induced thrombocytopenia \n\n Patients with known severe hepatic insufficiency manifested as international normalized ratio (INR) greater than or equal to 1.5 \n\n Patients with uncontrolled severe hypertension i.e. a systolic blood pressure > 220 mm Hg or diastolic blood pressure > 120 mm Hg during at least 2 measurements within 24 hours prior to randomisation \n\n Patients with ischaemic stroke at or within last 1 week prior to randomisation \n\n Patients with a known haemorrhagic stroke within 3 months prior to randomisation \n\n Patients with known bacterial endocarditis within 3 months prior to randomisation", - "brief_summary": "The objective of the study is to compare the safety of innohep\u00ae and Unfractionated Heparin (UFH) in terms of clinically relevant bleedings in elderly patients with impaired renal function for initial treatment of acute Deep Venous Thrombosis (DVT).~The primary response criterion is the percentage of patients with clinically relevant bleeding events prior to day 90 +/- 5.", - "NCTID": "NCT00277394" - }, - { - "brief_title": "Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With ABC", - "phase": "", - "drugs": "['Active Breathing Coordinator']", - "drugs_list": [ - "Active Breathing Coordinator" - ], - "diseases": "['Breast Neoplasms', 'Carcinoma, Ductal', 'Adenocarcinoma']", - "diseases_list": [ - "Breast Neoplasms", - "Carcinoma", - "Ductal", - "Adenocarcinoma" - ], - "enrollment": "57.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient must be 18 and older \n\n Patients must have histologically confirmed (by routine H&E staining) invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast. \n\n Patients must have undergone a segmental mastectomy (SM) or Mastectomy \n\n Patients must not have received prior radiation therapy to the breast at any time for any reason. \n\n Any patient with active local-regional disease prior to registration is not eligible. \n\n Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing age will be given a serum pregnancy test prior to study entry to ensure they are not pregnant. Women of child-bearing potential must use effective non-hormonal contraception while undergoing radiation therapy. \n\n Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment. \n\n All patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines. \n\n ", - "exclusion_criteria": ": \n\n Patients requiring oxygen \n\n Sarcoma or Squamous Cell pathology \n\n Right-sided breast cancers \n\n Metastatic disease to the breast", - "brief_summary": "Cardiac perfusion changes have been seen after whole breast / chest wall irradiation for breast cancer. The Active Breathing Coordinator (ABC) device theoretically decreases radiation exposure to the heart during radiation for breast cancer. In this trial cardiac perfusion changes or lack thereof will be quantified in women treated with radiation for breast cancer while using the ABC device. The control group of the study will consist of patients randomized to radiation therapy without the ABC device.", - "NCTID": "NCT00321048" - }, - { - "brief_title": "Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED)", - "phase": "Phase 3", - "drugs": "['ventilation-perfusion ratio', 'angiography']", - "drugs_list": [ - "ventilation-perfusion ratio", - "angiography" - ], - "diseases": "['Lung Diseases', 'Pulmonary Embolism']", - "diseases_list": [ - "Lung Diseases", - "Pulmonary Embolism" - ], - "enrollment": "", - "inclusion_criteria": "Men and women suspected of having a pulmonary embolism and who met the criteria to undergo angiography.", - "exclusion_criteria": "", - "brief_summary": "To evaluate the sensitivity and specificity of two major, widely used technologies, radionuclear imaging (ventilation-perfusion scanning) and pulmonary angiography, for the diagnosis of pulmonary embolism.", - "NCTID": "NCT00000566" - }, - { - "brief_title": "Ultrasound Elasticity Imaging of Venous Thrombi", - "phase": "Phase 1", - "drugs": "['Ultrasound', 'Ultrasound']", - "drugs_list": [ - "Ultrasound", - "Ultrasound" - ], - "diseases": "['Thrombosis']", - "diseases_list": [ - "Thrombosis" - ], - "enrollment": "254.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female subjects who have a diagnosis of chronic DVT that is at least 2 weeks old and are free from an acute DVT on top of your chronic DVT. \n\n Male and female patients who have been diagnosed with an acute blood clot by the Diagnostic Vascular Lab and w/symptoms occurring within the previous 2 weeks. \n\n Patients under the age of 18 who give assent (permission) and whose parents give consent. \n\n Adult patients who give consent. \n\n ", - "exclusion_criteria": ": \n\n None", - "brief_summary": "The purpose of this study is to see if the investigators can use ultrasound imaging to determine the type of clots in patients to help better manage their care.", - "NCTID": "NCT00726947" - }, - { - "brief_title": "Long Term Effects of Treating Submassive Pulmonary Embolism With Ultra-sound Accelerated Thrombolysis", - "phase": "", - "drugs": "['submassive PA treatment with Ekosonic endo device']", - "drugs_list": [ - "submassive PA treatment with Ekosonic endo device" - ], - "diseases": "['Submassive Pulmonary Embolism']", - "diseases_list": [ - "Submassive Pulmonary Embolism" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with acute (< or = 14 days)symptomatic pulmonary embolism by CT Angiogram of the thorax with embolus involving at least one main or lower lobe pulmonary artery and RV:LV ratio > 0.9 \n\n ", - "exclusion_criteria": ": \n\n age > 80 \n\n Recent thrombolytic therapy (with in 4 days) \n\n Active bleeding or know bleeding diathesis \n\n Known coagulopathy (including treatment with vitamin K antagonists) INR > 3 and/or PTT > 50 \n\n Thrombocytopenia (PLT cound < 100,000) \n\n History of any intracranial or intraspinal surgery, trauma or bleed \n\n Intracranial neoplasms, AVM, or aneurysm \n\n Recent (< 1 month) GI bleed \n\n Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy \n\n Recent (< 7 days) major surgery, trauma, or obstetrical delivery \n\n Renal insufficiency with eGFR < 45 ml/min \n\n Known allergy, hypersensitivity, or thrombocytopenia from heparin or tPA \n\n Hemodynamic instability defined as need for cardiopulmonay resuscitation, Systolic BP > 90 mm Hg for > 15 min or need for pressor agents to maintain BP > 90. \n\n Severe Hypertension (sustained systolic > 180 mm Hg or diastolic > 90 mm Hg. \n\n Pregnant patients \n\n known right to left shunt \n\n Large (>10 mm)intracardiac thrombus \n\n Use of thrombolytics or glycoprotein IIb/IIIa antangonists within 3 days of inclusion. \n\n Life expectancy < 30 days", - "brief_summary": "Patients with Submassive Pulmonary Embolism treated with ultra-sound therapy will have an improved right ventricular function 72 hours post treatment.", - "NCTID": "NCT01899339" - } - ], - "2": [ - { - "brief_title": "BRIPPED Scan for Evaluation of Emergency Department (ED) Patients With Shortness of Breath", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Dyspnea']", - "diseases_list": [ - "Dyspnea" - ], - "enrollment": "104.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects are included if they are between the ages of 18-89 and present to the Emergency Department with a chief complaint of shortness of breath or dyspnea. \n\n ", - "exclusion_criteria": ": \n\n known history of asthma, \n\n are 20 or more weeks pregnant, or \n\n have had thoraco-abdominal trauma in the past 72 hours.", - "brief_summary": "The B-RIPPED scan is a standardized ultrasound evaluation of pulmonary B-lines, Right ventricle size and strain, Inferior Vena Cava collapsibility, Pleural and Pericardial Effusion, Pneumothorax, Ejection Fraction, and lower extremity Deep Venous Thrombosis. Primary outcomes measured are the magnitude of change in differential diagnoses.", - "NCTID": "NCT01662843" - }, - { - "brief_title": "3 Months' Versus 6 Months' Anticoagulation in Patients With DVT and/or PE", - "phase": "Phase 4", - "drugs": "['Duration of anticoagulation', 'Warfarin duration']", - "drugs_list": [ - "Duration of anticoagulation", - "Warfarin duration" - ], - "diseases": "['Deep Vein Thrombosis', 'Pulmonary Embolism', 'Deep Vein Thrombosis With Pulmonary Embolism']", - "diseases_list": [ - "Deep Vein Thrombosis", - "Pulmonary Embolism", - "Deep Vein Thrombosis With Pulmonary Embolism" - ], - "enrollment": "2400.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients aged 18 years or more with suspected or proven DVT/PE whom the clinician intended to anticoagulate. \n\n ", - "exclusion_criteria": ": \n\n DVT/PE severe enough to require thrombolysis or pulmonary embolectomy. \n\n DVT/PE in the preceding 3 years. \n\n Neoplasia diagnosed/treated within previous 3 years. \n\n Pregnancy. \n\n Known major thrombophilias. \n\n Prolonged or continuous immobility or confinement to bed. \n\n Previous allergy to heparin or warfarin. \n\n Requirement for long-term anticoagulation. \n\n Inability to give informed consent.", - "brief_summary": "To determine whether 3 months' anticoagulation is as good as or better than 6 months' for the treatment of DVT/PE", - "NCTID": "NCT00365950" - }, - { - "brief_title": "Vibration Response Imaging in the Diagnosis of Pulmonary Disease", - "phase": "", - "drugs": "['Vibration Response Imaging']", - "drugs_list": [ - "Vibration Response Imaging" - ], - "diseases": "['Respiratory Diseases', 'Pulmonary Diseases', 'Thoracic Diseases', 'Lung Diseases']", - "diseases_list": [ - "Respiratory Diseases", - "Pulmonary Diseases", - "Thoracic Diseases", - "Lung Diseases" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n All adult ( \u2265 21 years old ) patients (inpatients and outpatients) under the care of the Department of Respiratory and Critical Care Medicine between 1/07/2008 and 31/05/2009 will be considered eligible. \n\n Children may have too small body sizes for the current standard sensors and will not be recruited. \n\n Other inclusion criteria will be ability to provide informed consent. \n\n ", - "exclusion_criteria": ": \n\n Conditions that will prevent the placement of sensors oh the patients back such as bony/chest wall deformity and contagious skin conditions. \n\n The presence of a pacemakers and pregnancy are also considered contraindications because of the yet undefined safety issues associated with these conditions.", - "brief_summary": "Vibration Response Imaging (VRI) is novel technology which records breath sounds via pizo-electric sensors and produces a digital image using a computer algorithm. It is radiation free and is portable to the patient's bedside. Data exists to show that the recordings from normal individuals differs from those who have pulmonary pathology. There is also evidence that recordings have high levels of inter and intra-observer reliability. However, data on specific VRI patterns for specific pathology is still needed before this can be used as a diagnostic tool. We aim to perform an open label feasibility trial on inpatient and outpatient pulmonary patients. Bedside clinical examination and chest auscultation will be used as the reference gold standard. Other diagnostic modalities that have been used as part of the patient's usual standard of care will also be used for comparison. Specifically breath sound progression, the maximal sound energy shape/distribution and the presence of artifactual sounds will be used to search for patterns that may be used for diagnosis. Sensitivity and specificity will be calculated for each disease (eg. asthma, emphysema, bronchiectasis, pneumonia, effusion, pneumothorax, etc)", - "NCTID": "NCT00719784" - }, - { - "brief_title": "Venous Thromboembolic Prophylaxis After Trauma: Three Times a Day Unfractionated Heparin Versus Twice a Day Enoxaparin", - "phase": "Phase 4", - "drugs": "['5000 Units unfractionated Heparin Q 8 hr', '30mg enoxaparin Q12 hr']", - "drugs_list": [ - "5000 Units unfractionated Heparin Q 8 hr", - "30mg enoxaparin Q12 hr" - ], - "diseases": "['Venous Thromboembolic Disease', 'Deep Vein Thrombosis', 'Pulmonary Embolism']", - "diseases_list": [ - "Venous Thromboembolic Disease", - "Deep Vein Thrombosis", - "Pulmonary Embolism" - ], - "enrollment": "495.0", - "inclusion_criteria": "inclusion criteria: \n\n Admitted to Scripps Mercy Trauma Service \n\n \u226518 Years old \n\n Stratified to either Significant or Highest risk of VTE by ACCP guidelines \n\n ", - "exclusion_criteria": ": \n\n Estimated Injury Severity Score (ISS) \u22649 \n\n Likely to be discharged before hospital day 7 \n\n Systemic coagulopathy defined with an International Normalized Ratio (INR) of \u22651.2 \n\n Body Mass Index (BMI) >40 \n\n Likely to Survive for <7 Days \n\n Pregnancy \n\n Evidence of renal insufficiency (Cr \u22651.3) \n\n Delayed transfer to this facility (>24 hrs) \n\n Prisoners", - "brief_summary": "The rate of venous thromboembolic events in trauma patients at high risk for deep vein thrombosis and pulmonary embolism receiving low dose unfractionated heparin every 8 hours will be equivalent or less than a similar group of patients given a standard every 12 hour dose of low molecular weight heparin.", - "NCTID": "NCT01729559" - }, - { - "brief_title": "Clinical Trial to Evaluate the Accuracy of [99mTc] ThromboView in the Detection of Deep Vein Thrombosis", - "phase": "Phase 2", - "drugs": "['ThromboView']", - "drugs_list": [ - "ThromboView" - ], - "diseases": "['Deep Vein Thrombosis']", - "diseases_list": [ - "Deep Vein Thrombosis" - ], - "enrollment": "94.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult man or woman, aged \u226518 years, presenting with suspected lower-limb initial or recurrent DVT. \n\n Moderate or high pre-test probability (PTP) for DVT. \n\n Onset of symptoms occurred within the last 7 days. \n\n Women of childbearing potential to have a negative pregnancy test as determined by measuring serum \u03b2-hCG levels at time of study enrolment. \n\n ", - "exclusion_criteria": ": \n\n Receiving anticoagulant therapy at therapeutic doses for >3 days. \n\n Life expectancy <3 months. \n\n Patient with a renal transplant. \n\n Renal dysfunction: serum creatinine >1.5x upper limit of normal range. \n\n Hepatic dysfunction: serum transaminases >3x upper limit of normal range. \n\n Current pregnancy or lactation; or conception intended within 90 days of enrolment \n\n Of childbearing potential and unwilling to use adequate contraception for 30 days following enrolment \n\n Unable to undergo lower limb ascending venography on symptomatic leg(s). \n\n Allergy or other contraindication to intravenous contrast dye. \n\n Prior exposure to murine or humanized antibodies. \n\n Prior imaging studies with: I131 within the last month; In111 or Ga67 within the last 2 weeks; Tc99m labelled RBCs, WBCs or albumin within the last 48 hours; Tc99m or F18 within the last 24 hours; prior non-imaging, non-therapeutic nuclear medicine studies with I131 (eg., 24-hour RAI uptake) within the last 2 weeks. \n\n Previous participation in the present study. \n\n Geographic inaccessibility that precludes follow-up visits. \n\n Patient is unwilling or unable to provide informed consent. \n\n Patient is unsuitable for the study, at the Study Investigator's discretion.", - "brief_summary": "The assessment of patients with suspected deep vein thrombosis (DVT) is a common clinical scenario that, despite major advances in diagnostic testing, continues to be challenging.~The diagnosis of DVT remains problematic in:~patients with suspected first DVT who have a moderate or high pre-test probability (PTP) for DVT and a normal compression ultrasound (CUS);~patients with suspected recurrent DVT; and~patients in whom CUS or contrast venography is technically difficult or not feasible due to patient characteristics.~In patients with suspected first DVT who have a moderate or high PTP and a normal CUS, DVT occurs in up to 10% of cases. Thus, additional diagnostic testing is required, such as venography or serial CUS, so that DVT is not missed, but these approaches are costly and invasive.~In patients with suspected recurrent DVT, currently used diagnostic approaches are problematic because they all have limitations in differentiating old disease from true recurrent disease.~CUS is technically difficult in selected patients, particularly those who are obese.~Contrast venography is the gold standard diagnostic test for DVT to which all other diagnostic venous imaging modalities for DVT are compared and judged. The Food and Drug Administration (FDA) requires that a new diagnostic test for DVT be assessed against venography.~[99mTc] ThromboView\u00ae is a novel diagnostic test based on a 99mTc-labeled monoclonal antibody specific for D-dimer fragments of cross-linked fibrin that are found in acute DVT. After intravenous injection of [99mTc] ThromboView\u00ae, there is uptake of the monoclonal antibody by acute, D-dimer rich, venous thrombi. This is visualized with nuclear medicine imaging as an area of increased radioisotope activity that corresponds to the location of DVT.~Based on the biologic and imaging characteristics of [99mTc] ThromboView\u00ae, this diagnostic test has the potential to:~identify small non-occlusive proximal DVT or distal DVT in patients with a moderate or high PTP and normal CUS;~differentiate old from new DVT in patients with suspected recurrent DVT;~diagnose or exclude DVT in patients in whom CUS is not technically feasible; and~provide an alternative to venography that is non-invasive, has no contrast-related toxicity and is easily administered.~The present study is the first phase II clinical trial of [99mTc] ThromboView\u00ae in patients with suspected initial or recurrent DVT in whom DVT has been confirmed or excluded by venography. A phase II clinical trial to investigate the diagnostic accuracy of [99mTc] ThromboView\u00ae is justified because:~ThromboView\u00ae was well tolerated, with no significant toxicity in studies involving animals and healthy volunteers; and~it has shown promise in Phase I trials as a non-invasive diagnostic test for acute DVT.", - "NCTID": "NCT00123734" - }, - { - "brief_title": "Sonography Outcomes Assessment Program for Lower Extremity Deep Venous Thrombosis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Deep Venous Thrombosis']", - "diseases_list": [ - "Deep Venous Thrombosis" - ], - "enrollment": "51.0", - "inclusion_criteria": "inclusion criteria: \n\n inclusion criteria: \n\n Presenting signs and symptoms sufficiently suspicious for lower extremity DVT to warrant a formal radiology study in the opinion of the treating physician AND EITHER 2a. Moderate or high pre-test clinical probability of DVT (Wells Criteria) OR 2b. Low pre-test clinical probability of DVT with a positive D-dimer \n\n ", - "exclusion_criteria": ": \n\n ", - "brief_summary": "Currently, most emergency physicians have limited access to obtaining formal radiology ultrasound studies, particularly overnight. Many are forced to adopt risky and expensive strategies in managing their patients with suspected deep venous thrombosis (DVT) who present during off-hours: for low risk patients, discharging without anticoagulation and arranging for outpatient studies; for moderate to high risk patients, empirically anticoagulating and admitting to the hospital to await definitive testing. If emergency physicians could reliably perform an accurate ultrasound exam for DVT, such risks could be obviated.~This is a prospective, observational cohort study assessing the accuracy of emergency physician diagnosis of proximal DVT using compact ultrasound equipment and a simplified compression technique. The value of color flow doppler and augmentation will also be assessed. Outcomes (sensitivity, specificity, positive likelihood ratio and negative likelihood ratio) will be assessed at 30 days.~Prior to enrolling patients in the study, emergency physicians will undertake a 2 hour training course on the performance of the simplified compression technique for the diagnosis of lower extremity DVT. Emergency physicians will perform the DVT ultrasound exam on study subjects with suspected DVT. Clinical management of the study subjects will not be altered; all subjects will proceed to receive a formal DVT ultrasound study by the radiology department which will serve as the criterion reference for the study.", - "NCTID": "NCT00178789" - }, - { - "brief_title": "Diffusion of Use of Low Molecular Weight Heparin for Thrombosis on the Medicine Services", - "phase": "", - "drugs": "['Observation']", - "drugs_list": [ - "Observation" - ], - "diseases": "['Thrombosis']", - "diseases_list": [ - "Thrombosis" - ], - "enrollment": "645.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients admitted to General Medicine Services with a primary or secondary diagnosis related to venous thromboembolism \n\n ", - "exclusion_criteria": ": \n\n Non-General Medicine Services patients", - "brief_summary": "The purpose of this research is to gain insight into the way in which physicians adopt new practice techniques. In particular, we are interested in how medical innovations diffuse throughout social networks. We wish to examine the diffusion of Low Molecular Weight Heparin (LMWH) use for Deep Vein Thrombosis (DVT) throughout the social network of general internal medicine interns, residents, and attendings at the University of Chicago Hospital. In numerous clinical trials, LMWH has been demonstrated to be as effective as unfractionated heparin as a bridge to long-term anticoagulation therapy with Coumadin, with the added benefit of early discharge from the hospital with easy dosing, no need for monitoring, and home therapy. A DVT critical pathway was established at the U of C in 1998, and LMWH was used off-label for that purpose beginning in 1997. However, it is unclear how quickly the use of LMWH was adopted by the physicians on the general medicine services, or whether there exists a pattern for this adoption.", - "NCTID": "NCT00203970" - }, - { - "brief_title": "DVT Ultrasound in the Emergency Department", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Deep Vein Thrombosis', 'DVT']", - "diseases_list": [ - "Deep Vein Thrombosis", - "DVT" - ], - "enrollment": "288.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 or older \n\n Suspect of having DVT \n\n ", - "exclusion_criteria": ": \n\n Known DVT \n\n DVT with in previous 6 months \n\n DVT Ultrasound within the last 6 months", - "brief_summary": "Emergency Medicine (EM) Residents routinely conduct bedside ultrasound exams in the Emergency Department (ED) employing the two point compression method. This study endeavors to investigate the accuracy and utility of bedside ultrasound for Deep Vein Thrombosis (DVT) in the ED by EM Residents by comparing the results of that exam against the gold standard of a DVT ultrasound performed in the Radiology Department and interpreted by a Radiologist.", - "NCTID": "NCT02369263" - }, - { - "brief_title": "Italian Pulmonary Embolism Registry - IPER", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Acute Pulmonary Embolism']", - "diseases_list": [ - "Acute Pulmonary Embolism" - ], - "enrollment": "1700.0", - "inclusion_criteria": "inclusion criteria: \n\n consecutive patients with acute pulmonary embolism \n\n ", - "exclusion_criteria": ": \n\n age <18 years", - "brief_summary": "RAZIONALE~Pulmonary embolism is a complex disease, with a highly variable clincal presentation. Diagnosis starts with clinical probability assessment mainly based on medical history and rapidly available clinical data. Pulmonary embolism can be managed by emergency department, cardiology, pneumology geriatrics or internal medicine physicians. Thus, initial clinical management can varies based on the attitude of the attending physician.~Diagnosis is a crucial point as it can influence short term mortality.~OBJECTIVE~The registry has 3 main objectives:~educational objective,~improvement in the knowledge of epidemiology, management and outcome of acute pulmonary embolism in Italy~scientific objective", - "NCTID": "NCT01604538" - }, - { - "brief_title": "V/Q SPECT for Diagnosis of Pulmonary Embolism", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pulmonary Embolism']", - "diseases_list": [ - "Pulmonary Embolism" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Pulmonary embolism suspicion", - "exclusion_criteria": "", - "brief_summary": "The objective of the study was to assess diagnostic performance of V/Q SPECT for the diagnosis of pulmonary embolism by comparing V/Q SPECT results to a validated diagnostic strategy.", - "NCTID": "NCT01183026" - } - ] - }, - { - "patient_id": "sigir-20146", - "patient": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", - "0": [ - { - "brief_title": "The Diabetes Medication Adherence Promotion Intervention Trial", - "phase": "", - "drugs": "['Diabetes MAP Intervention']", - "drugs_list": [ - "Diabetes MAP Intervention" - ], - "diseases": "['Diabetes Mellitus, Type 2']", - "diseases_list": [ - "Diabetes Mellitus", - "Type 2" - ], - "enrollment": "151.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults 18 years and older (to be confirmed by electronic health record) \n\n Individuals who have received a diagnosis for type 2 diabetes mellitus (T2DM) \n\n Enrolled as a patient in the Vanderbilt APPC or the Eskind Diabetes Clinic \n\n Registered My Health at Vanderbilt user \n\n Recent A1c of 7.0 or greater \n\n Individuals currently being treated with oral and/or injectable diabetes medication (to be confirmed through electronic health record) \n\n ", - "exclusion_criteria": ": \n\n Non-English speakers (determined by a trained research assistant) \n\n Individuals with a severe hearing or visual impairment (determined subjectively by a trained research assistant) \n\n Individuals with delirium or a severe cognitive impairment (determined by a lack of orientation to person, place, and time) \n\n Individuals who report a caregiver administers their diabetes medications \n\n Individuals who report they do not have a mobile phone or computer with internet access \n\n Individuals unwilling and/or unable to provide written informed consent", - "brief_summary": "A significant percentage of persons with diabetes fail to properly take their prescribed oral hypoglycemic agents (OHA) and insulin. Non-adherence to medications among diabetes patients is associated with poor health outcomes including suboptimal glycemic control, diabetes-related complications, elevated health costs and increased risk of hospitalization and mortality. Given the substantial impact of non-compliance on the health of patients, prior studies have sought to draw links between medication adherence and patient factors.~Research shows that web-based interventions that support patients' medication-related knowledge, motivation and skills effectively improve compliance.~The purpose of this study is to evaluate the impact of a patient web portal (PWP)-delivered medication adherence promotion intervention on medication adherence and glycemic control among patients with type 2 diabetes (T2DM). The intervention aims to (1) increase self-reported adherence to glucose lowering agents (GLAs) and (2) improve diabetes health outcomes (decreased HbA1c) by increasing patients' medication adherence-related knowledge, motivation and skills.~This research will greatly enhance the investigators' understanding of medicine compliance and the factors that effectively improve adherence among high-risk patients with diabetes. Knowledge gained from this work may inform future internet-based patient portals that support disease management and medication adherence more broadly.", - "NCTID": "NCT02458495" - }, - { - "brief_title": "Novel Model for South Asian Treatment in Diabetes (NaMaSTe-Diabetes) Trial in Primary Care", - "phase": "", - "drugs": "['Culturally tailored diabetes program']", - "drugs_list": [ - "Culturally tailored diabetes program" - ], - "diseases": "['Type 2 Diabetes Mellitus']", - "diseases_list": [ - "Type 2 Diabetes Mellitus" - ], - "enrollment": "600.0", - "inclusion_criteria": "inclusion criteria: \n\n age >19 years of age \n\n type 2 diabetes mellitus requiring at least one medication (oral hypoglycemic agent and/or insulin) to control diabetes \n\n A1C \u22657% in past 1 year \n\n willingness/ability to attend the Diabetes education, dietician, and peer sessions and follow up assessments \n\n ability to provide informed consent \n\n self identify as South Asian (from India, Pakistan, Sri Lanka, or Bangladesh) regardless of generational status or timing of immigration with ability to speak in English or Punjabi. \n\n ", - "exclusion_criteria": ": \n\n life- limiting illness <12 months \n\n physical inability to exercise \n\n recurrent severe hypoglycemia or hypoglycaemic unawareness \n\n family member of, or living in same household as a participant \n\n pregnancy or gestational diabetes.", - "brief_summary": "South Asians (SA) living in Canada and globally have high rates of type 2 diabetes (diabetes). Despite the burden of diabetes in this population, diabetes management remains poor. SA patients are less likely to exercise, follow a healthy diet (4), participate in exercise programs (5), and are 24% less likely to achieve glucose, blood pressure and lipid targets for diabetes than the general population (6). 55-60% of SA patients were non-adherent to their diabetes life-saving medications, compared to 30-35% non-adherence in the general population (7). This large gap in diabetes care is not surprising given language and communication barriers between primary care providers and SA patients (8-10), lack of knowledge about diabetes (8-11), preference for alternative therapies (12-14) and fundamentally different cultural beliefs on diabetes and diabetes management (15-18). Although there is some preliminary evidence that culturally tailored, chronic disease models may improve outcomes (21-24), the current evidence base is insufficient to justify the system modifications required to provide culturally tailored care across primary care settings in Canada. We propose to conduct a randomized controlled trial to assess the impact of a novel culturally tailored lifestyle and medication adherence intervention in SA patients with poorly controlled diabetes. The study is called the Novel Model for South Asian diabetes Treatment (NaMaSTe-Diabetes) trial in primary care.", - "NCTID": "NCT02136654" - }, - { - "brief_title": "Comparison of Resin Salve and Octenidine in Patients With Neuropathic Diabetic Foot Ulcers", - "phase": "", - "drugs": "['Resin salve treatment', 'Octenidine treatment']", - "drugs_list": [ - "Resin salve treatment", - "Octenidine treatment" - ], - "diseases": "['Diabetes Mellitus', 'Diabetes Complications', 'Diabetic Neuropathies', 'Wound Infection']", - "diseases_list": [ - "Diabetes Mellitus", - "Diabetes Complications", - "Diabetic Neuropathies", - "Wound Infection" - ], - "enrollment": "35.0", - "inclusion_criteria": "inclusion criteria: \n\n an adult patient (18-80 years) suffering from infected neuropathic fore- or mid-foot ulceration originated from type I or II diabetes (PEDIS-classification \u2265 Grade II). \n\n ", - "exclusion_criteria": ": \n\n a patient whose life expectancy is less than 6 months \n\n an ulceration of ischemic or neuroischemic origin \n\n presence of systemic inflammatory response signs \n\n heel ulceration \n\n presence of osteomyelitis \n\n pregnancy \n\n known hypersensitivity to any of the ingredient including in the study or control treatment products \n\n a patient who is unable to give informed consent \n\n a patient who has an advanced malignant disease.", - "brief_summary": "Prevalence of diabetic foot ulcers are reported to be 15% in patients who suffer from diabetes and ulcerations are present in 84% of all diabetes-related amputations. Peripheral neuropathy leading to unperceived trauma seems to be the major cause of diabetic foot ulcers with 45-60% of ulcers to be considered merely neuropathic and 45% of mixed, neuropathic and ischemic etiology. Ulceration of lower limb is one of the most common complications related with diabetes and one of the major causes for hospitalization of diabetic patients. The most significant contributors to diabetic lower limb ulceration are neuropathy, deformity, uncontrolled elevated plantar pressure, poor glycemic status, peripheral vascular disease, male gender and duration of diabetes. Treatment of lower limb ulcers imposes an enormous burden on health care resources worldwide, and at least 33% of all expenses are spent to treat diabetic ulcers manifested as a complication of diabetes.~Although at least 170 topical wound care products are available, evidence of the superiority of one over another is tenuous, well-designed randomized, controlled trials are rare, and the number of case-control or observational studies is limited. In recent years, salve prepared from Norway spruce (Picea abies) resin has successfully been used in medical context to treat both acute and chronic wounds and ulcers of various origins. The objective of this prospective, randomized and controlled clinical trial is to investigate healing rate and healing time of neuropathic diabetic foot ulcer in patients, who are suffering from infected fore- or mid-foot ulceration (PEDIS-classification \u2265 Grade II; 19) originated from Type I or II diabetes, and in patients whose diabetic ulcerations are candidates for topical treatment with resin (Study treatment) or octenidine (Control treatment). In addition, factors contributing with delayed healing of ulceration, antimicrobial properties, safety and cost-effectiveness of the resin salve treatment and control treatment will be analyzed.", - "NCTID": "NCT02169167" - }, - { - "brief_title": "Behavior Therapy for Families of Diabetic Adolescents", - "phase": "Phase 3", - "drugs": "['Behavioral Family Systems Therapy for Diabetes']", - "drugs_list": [ - "Behavioral Family Systems Therapy for Diabetes" - ], - "diseases": "['Type 1 Diabetes Mellitus']", - "diseases_list": [ - "Type 1 Diabetes Mellitus" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Age of adolescent 12-<17 years Type 1 diabetes for >2 years Living in a home environment English reading ability at 5th grade level or above Established diabetes care at participating site Working telephone service Intent to remain living in same region for next 18 months - \n\n ", - "exclusion_criteria": ": \n\n Presence of another chronic systemic disease Inpatient psychiatric treatment of patient or caregiver in prior 6 months Current outpatient treatment of psychosis, major depression or substance use disorder in parent/caregiver \n\n -", - "brief_summary": "Effective adaptation to type 1 diabetes mellitus requires adolescents and their families to work together effectively to solve problems and resolve disagreements in order to achieve acceptable diabetic control and treatment adherence. Many studies show that problematic family communication, insufficient parental involvement in care and parent-adolescent conflict are associated with poor adherence and poor diabetic control. This study tests a family communication and problem solving intervention by randomizing families of adolescent with type 1 diabetes to 6 months' treatment either with the experimental intervention, continuation in standard medical care for diabetes, or participation in a multifamily educational support group. Families are then followed for an additional 12 months to examine the longer-term effects of the interventions on the targeted diabetes outcomes.", - "NCTID": "NCT00358059" - }, - { - "brief_title": "Pet Ownership and Glucose Control in Type 1 Diabetes", - "phase": "", - "drugs": "['Pet Fish', 'Picture of a fish']", - "drugs_list": [ - "Pet Fish", - "Picture of a fish" - ], - "diseases": "['Type 1 Diabetes Mellitus']", - "diseases_list": [ - "Type 1 Diabetes Mellitus" - ], - "enrollment": "29.0", - "inclusion_criteria": "inclusion criteria: \n\n English-speaking patients \n\n 10 to 18 years \n\n diagnosed with type 1 diabetes for at least 12 months \n\n poor diabetes control as defined by having a hemoglobin A1c value > 8% \n\n ", - "exclusion_criteria": ": \n\n type 2 diabetes \n\n developmental delay \n\n current participation in another study that may impact glycemic control", - "brief_summary": "The investigators' long-term goal is to discover novel, inexpensive and feasible strategies to improve the management and well-being of youth with T1DM. The specific objective of this proposal is to quantify the impact of responsible pet ownership on the glycemic control and health related quality of life in youth with T1DM.", - "NCTID": "NCT01733524" - }, - { - "brief_title": "Neurogenic Inflammation in Diabetes", - "phase": "", - "drugs": "['Intracutaneous injection of Candida albicans antigen.', 'Temperature measurement.']", - "drugs_list": [ - "Intracutaneous injection of Candida albicans antigen.", - "Temperature measurement." - ], - "diseases": "['Diabetes Mellitus', 'Polyneuropathies', 'Arthropathy, Neurogenic']", - "diseases_list": [ - "Diabetes Mellitus", - "Polyneuropathies", - "Arthropathy", - "Neurogenic" - ], - "enrollment": "41.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with type 2 diabetes with and without polyneuropathy. \n\n Patients with type 2 diabetes with a history of Charcot's disease. \n\n Healthy controls. \n\n Signed informed consent. \n\n ", - "exclusion_criteria": ": \n\n Peripheral arterial disease: toe pressure < 70 mm Hg and/or transcutaneous oxygen tension < 40 mm Hg and/or claudication. \n\n Renal insufficiency: MDRD creatinin clearance < 30 ml/min. \n\n Systemic disease such as vasculitis or rheumatoid arthritis. \n\n Malignancy. \n\n (Diabetic) foot ulcer. \n\n Gout. \n\n Bacterial infection of an extremity. \n\n Skin condition of the dorsal aspect of the foot or the medial side of the upper arm. \n\n Bleeding disorder such as hemophilia. \n\n Use of medication for asthma. \n\n Impaired immunity such as in HIV/AIDS. \n\n Capillary blood glucose < 3 mmol/l or > 20 mmol/l at the time of the study. \n\n Peripheral oedema. \n\n Vaccination in the two months prior to study inclusion. \n\n Chemotherapy or radiation therapy in the twelve months prior to study inclusion. \n\n Surgery in the two months prior to study inclusion. \n\n Previous adverse reaction to Candida albicans antigen. \n\n Acute infection at the time of the study or in the month prior to study inclusion. \n\n Transfusion in the two months prior to study inclusion. \n\n Use of immunosuppressants in the two months prior to study inclusion. \n\n Pregnancy or breastfeeding.", - "brief_summary": "Polyneuropathy is a complication of diabetes mellitus which leads to decreased sensation in arms and legs. This in turn can lead to the development of (infected) foot ulcers. Charcot's disease can also be a consequence of polyneuropathy. Patients with Charcot's disease suddenly develop a red, warm and swollen foot, like an infection. Charcot's disease leads to foot fractures. After these fractures have healed, the shape of the foot can be dramatically altered. This altered shape of the foot increases the risk of developing foot ulcers. Nerves are important in regulating the inflammatory response. This study aims to investigate whether the inflammatory response is different in patients with polyneuropathy with and without a history of Charcot's disease.", - "NCTID": "NCT01370837" - }, - { - "brief_title": "Identification and Therapy Efficacy of Type 2 Diabetes in Hispanic Patients", - "phase": "", - "drugs": "['Sustacal challenge']", - "drugs_list": [ - "Sustacal challenge" - ], - "diseases": "['Diabetes Mellitus, Non-Insulin-Dependent']", - "diseases_list": [ - "Diabetes Mellitus", - "Non-Insulin-Dependent" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Approximately 30 pediatric patients (ages 10-18) believed to have a diagnosis of type 2Y. Each subject must have been diagnosed for at least one year. \n\n ", - "exclusion_criteria": ": \n\n Patients over the age of 18 or under the age of 10 \n\n Patients in whom intellectual functioning is impaired sufficiently to interfere with the understanding of the protocol.", - "brief_summary": "The two major types of diabetes are type 1 and type 2 diabetes. Although most patients with type 2 diabetes are older than age 40, type 2 diabetes has been reported with increasing frequency among patients under the age of 20. This form of diabetes has been called type 2 diabetes of youth, abbreviated type 2Y. Little is known about the etiology of type 2Y; however, clinicians believe that it occurs most commonly in obese children of particular ethnic groups. A positive family history appears to be one major risk factor for developing type 2Y diabetes. The individual contribution of ethnicity, obesity, and genetics to type 2Y have yet to be elucidated. There is no consensus regarding treatment with type 2Y diabetes. Observation of our Hispanic patients in the Houston area reveals a large number with type 2Y. The major purpose of this study is to examine the genetic and environmental risk factors such as family history, ethnicity, and obesity in Hispanic children with type 2Y diabetes. SPECIFIC AIMS: 1) To examine the genetic and environmental risk factors and clinical signs associated with type 1 diabetes and type 2 diabetes of youth. 2) To compare the efficacy of the treatment modalities, insulin and oral agents, in type 2Y patients. METHODS: We will undertake a retrospective case study, to include a review of hypothesized risk factors in all the medical records of pediatric diabetes patients seen at University of Texas. We anticipate that approximately 200 patients with type 1 diabetes and 30 patients with type 2Y diabetes will be identified. A Sustacal challenge test will be done in patients with a suspected diagnosis of type 2Y in order to confirm the clinical diagnosis. Parents will be contacted by phone for a detailed pedigree intake. Type 1 and type 2Y patients will be compared for each of the studied features. A retrospective review of diabetes type 2 therapies used in type 2Y patients will be undertaken through further examination of the medical records in order to compare insulin treatment to oral agents. We will also test a subset of the patients for the gene identified in adult Hispanics with type 2 diabetes.", - "NCTID": "NCT00004572" - }, - { - "brief_title": "Effect of Local Application of Boron on Diabetic Foot Ulcers", - "phase": "Phase 1", - "drugs": "['boron gel', 'Placebo']", - "drugs_list": [ - "boron gel", - "Placebo" - ], - "diseases": "['Diabetic Foot Ulcer']", - "diseases_list": [ - "Diabetic Foot Ulcer" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n diabetic food ulcer classified byInternational Working Group of the Diabetic Foot (IWGDF) as grade 1 and 2 \n\n ", - "exclusion_criteria": ": \n\n previous vascular surgery on the side that the ulcer is present \n\n uncontrolled diabetes mellitus \n\n presence of osteitis, abscess, osteomyelitis, gangrene on the side that the ulcer is present \n\n diabetic food ulcer classified byInternational Working Group of the Diabetic Foot (IWGDF) as grade 3", - "brief_summary": "Boron as a naturally occurring element has some metabolic and inflammatory actions. The antibacterial activity against gram negative bacteria is also known. Boron deficiency is shown to be related with impaired wound bone healing in rats. Therefore, special wound care formulas containing boron may have some positive effect on wound healing of the patients with diabetic foot ulcers.", - "NCTID": "NCT02087215" - }, - { - "brief_title": "Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers", - "phase": "Phase 3", - "drugs": "['Bi-layered cell therapy (Apligraf)']", - "drugs_list": [ - "Bi-layered cell therapy (Apligraf)" - ], - "diseases": "['Diabetic Foot']", - "diseases_list": [ - "Diabetic Foot" - ], - "enrollment": "82.0", - "inclusion_criteria": "inclusion criteria: \n\n diabetic ulcer of primarily neuropathic origin on the plantar region of the forefoot \n\n ulcer extending through the dermis but without sinus tract, tendon, capsule or bone exposure \n\n ulcer present for at least 2 weeks and measuring 1- 16 cm2 \n\n diminished sensesation on target extremity/foot \n\n ulcer is not infected \n\n Type 1 or 2 diabetes with adequate glycemic control \n\n Adequate vascular supply to the target extremity \n\n ", - "exclusion_criteria": ": \n\n Charcot foot \n\n Non-neuropathic ulcers \n\n Skin cancer within or adjacent to the target ulcer \n\n Osteomyelitis or an infected ulcer \n\n Clinically significant medical condition that would impair wound healing \n\n Females who are pregnant \n\n Received within 4 weeks of study entry systemic corticosteriods, immunosuppresive agents, radiation therapy or chemotherapy", - "brief_summary": "The purpose of this study is to determine the ability of Apligraf to improve the time to and incidence of complete wound closure of diabetic foot ulcers, as compared to diabetic foot ulcers treated with standard therapy.", - "NCTID": "NCT00512538" - }, - { - "brief_title": "Olivamine-containing Products in the Management of Patients With Nonhealing Lower Extremity Ulcers", - "phase": "", - "drugs": "['Olivamine containing wound care products']", - "drugs_list": [ - "Olivamine containing wound care products" - ], - "diseases": "['Ulcer', 'Skin Ulcer', 'Leg Ulcer', 'Diabetic Foot']", - "diseases_list": [ - "Ulcer", - "Skin Ulcer", - "Leg Ulcer", - "Diabetic Foot" - ], - "enrollment": "5.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient is 18 years old or older. \n\n Patient has a diagnosis of arterial, diabetic foot, venous insufficiency, or pressure ulcer or surgical and traumatic wound. \n\n Patient's target study ulcer/wound is a lower extremity full thickness ulcer/wound not involving tendon, capsule, or bone. \n\n Patient's target study ulcer/wound and is \u22651.0 cm2 and \u2264 10.0 cm2 in size at the day of initial consult. \n\n Study ulcer/wound has been present for greater than 6 weeks prior to initial consult. \n\n Patients with Charcot foot deformities can be entered so long as the Charcot disease is not active, and the ulcer can be offloaded by an orthotic device. \n\n The patient has adequate circulation to the lower extremity as evidenced by an ABI (measured by Doppler) of \u2265 0.7. If the patient has non-compressible leg arteries, as documented by an ABI >1.3, then the patient must have a Toe-Brachial Index be > 0.6, or a toe pressure >50 mm Hg. \n\n Patient must have adequate in-home support to comply with all protocol-mandated visits and procedures, offloading or pressure redistribution as required, and proper application of study products and wound care regimen. \n\n Patient or his/her legal representative has read and signed the Institutional Review Board-approved Informed Consent form before Screening. \n\n ", - "exclusion_criteria": ": \n\n An ulcer/wound that is \u226510.0 cm2 and \u2264 1.0 cm2 in size at the day of initial consult is not eligible for this study. \n\n Patient has clinical evidence of gangrene or infection on any part of the affected foot. \n\n The patient is judged by the investigator or study staff to be unable or unlikely to comply with daily wound care instructions, or study visits. \n\n Patient has clinical evidence of active sepsis or invasive infection (e.g., cellulitis, osteomyelitis). \n\n Patient has muscle, tendon, or bone exposure in any ulcer bed. \n\n Patient has known sensitivity or allergy to any component of the study product - Olivamine10. \n\n Patient has one or more medical condition(s), including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the - Investigator would make the patient an inappropriate candidate for this wound healing study. \n\n Patient has a malignant disease (other than squamous or basal cell carcinoma of the skin) not in remission for five years or more. \n\n Patient has known alcohol or drug abuse. \n\n Patient has a hematocrit greater than 60% or less than 27%. \n\n Patient's diabetes is under poor control as manifested by HbA1c of >10.0%. \n\n Patient has clinically significant renal insufficiency or creatinine greater than 2.0 mg/dL. \n\n Patient has chronic liver disease or clinically significant liver enzyme abnormality as evidenced by elevated AST, ALT, or bilirubin greater than 1.5 times upper limit of normal (ULN). \n\n Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, or is anticipated to require such agents during the course of the study. \n\n Patient is using tobacco, or is exposed to a current smoker in their household. Patients may participate in the study if they have not used tobacco for 3 months and have not had a smoker in their household for 3 months. \n\n Patient is using any form of nicotine including nicotine patches, gums, or sprays. \n\n Patient has Acquired Immunodeficiency Syndrome (AIDS) or is known to be infected with Human Immunodeficiency Virus (HIV).", - "brief_summary": "In this study, the investigators hypothesize that the use of olivamine-containing products in the management of patients with compromised nonhealing lower extremity ulcers is feasible in the Philippine setting. It will result in complete ulcer healing or wound closure after 16 weeks.", - "NCTID": "NCT01657318" - }, - { - "brief_title": "A Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes", - "phase": "Phase 1", - "drugs": "['NN1952', 'insulin aspart', 'placebo', 'NN1952', 'insulin aspart', 'placebo']", - "drugs_list": [ - "NN1952", - "insulin aspart", - "placebo", - "NN1952", - "insulin aspart", - "placebo" - ], - "diseases": "['Diabetes', 'Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2', 'Healthy']", - "diseases_list": [ - "Diabetes", - "Diabetes Mellitus", - "Type 1", - "Diabetes Mellitus", - "Type 2", - "Healthy" - ], - "enrollment": "84.0", - "inclusion_criteria": "inclusion criteria: \n\n FOR TRIAL PART 1, THE FOLLOWING APPLIES: \n\n Gender: male \n\n Age: 18-55 years \n\n BMI (body mass index): 18-28 kg/m2 \n\n Study participants considered to be healthy \n\n FOR TRIAL PART 2, THE FOLLOWING APPLIES: \n\n Gender: male or female of no childbearing potential \n\n Age: 18-65 years \n\n Type 1 diabetes: BMI (body mass index): 18-28 kg/m2 \n\n Type 2 diabetes: BMI (body mass index): 22-35 kg/m2 \n\n Type 1 or type 2 diabetes for at least 12 months \n\n Type 1 diabetes: Treatment with insulin for at least 12 months \n\n Type 2 diabetes: Treatment with insulin for at least 3 months \n\n ", - "exclusion_criteria": ": \n\n Known or suspected allergy to the trial product or related products \n\n Presence of illness or infection that may confound the results of the study or pose a risk to the study participant by dosing NN1952, as judged by the Investigator \n\n Presence of acute gastrointestinal symptoms (for example nausea, vomiting, heartburn or diarrhoea)", - "brief_summary": "This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerance, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NN1952 as tablets in healthy volunteers and subjects with type 1 and type 2 diabetes.~The trial consists of two parts. In part 1, single escalating doses of NN1952, placebo or insulin aspart will be given to healthy volunteers. In part 2, subjects with type 1 or type 2 diabetes will receive single doses of NN1952 (with/without a meal), insulin aspart and placebo.", - "NCTID": "NCT01028404" - }, - { - "brief_title": "Comparing the Pharmacodynamics and Pharmacokinetics of Explorative Formulation of Insulin Degludec With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes", - "phase": "Phase 1", - "drugs": "['insulin degludec', 'insulin glargine']", - "drugs_list": [ - "insulin degludec", - "insulin glargine" - ], - "diseases": "['Diabetes', 'Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']", - "diseases_list": [ - "Diabetes", - "Diabetes Mellitus", - "Type 1", - "Diabetes Mellitus", - "Type 2" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Glycosylated haemoglobin (HbA1c) below or equal to 10 procent based on central laboratory results \n\n Specific inclusion criteria for subject with type 1 diabetes: \n\n Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months prior to screening \n\n Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive) \n\n Specific inclusion criteria for subject with type 2 diabetes: \n\n Diagnosed with type 2 diabetes mellitus for at least 12 months prior to screening \n\n Treated with insulin for the past 3 months prior to screening \n\n Body Mass Index (BMI) between 22.0 and 35.0 kg/ m^2 (both inclusive) \n\n ", - "exclusion_criteria": ": \n\n Subject with a history of significant multiple drug allergies or with a known allergy or suspected allergy to the trial product or any medicine chemically related to the trial product,as judged by the Investigator. \n\n Subject with a history of or presence of cancer \n\n Any condition that the Investigator and/or Sponsor feels would interfere with study \n\n Specific ", - "brief_summary": "This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics (the effect of the investigated drug on the body) and pharmacokinetics (the exposure of the trial drug in the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, with insulin glargine in subjects with type 1 and type 2 diabetes.", - "NCTID": "NCT01865292" - }, - { - "brief_title": "Off- Loading Shoe to Improve Healing and Prevention of Recurrence of Neuropathic Diabetic Plantar Foot Ulcers", - "phase": "Phase 3", - "drugs": "['SANIDIAB', 'BAROUK']", - "drugs_list": [ - "SANIDIAB", - "BAROUK" - ], - "diseases": "['Diabetes Mellitus', 'Diabetic Neuropathic Foot Ulcer']", - "diseases_list": [ - "Diabetes Mellitus", - "Diabetic Neuropathic Foot Ulcer" - ], - "enrollment": "33.0", - "inclusion_criteria": "inclusion criteria : \n\n More of 18 years old man or woman \n\n Type 1 or 2 Diabetes mellitus \n\n A new plantar ulcer of the fore foot or the toes \n\n GRADE 1A or 2 A of the University of Texas Classification \n\n Neuropathy assessed by absence of sensation in 10g monofilament test \n\n ", - "exclusion_criteria": " \n\n Severe angiopathy (Grade 3 of the PEDIS classification) \n\n Osteomyelitis or cellulitis of the foot \n\n Transmetatarsal amputation \n\n Other study in course \n\n Immunosuppressive drugs, antibiotic therapy, \n\n Hepatic insufficiency \n\n No possibility to follow the patients every 14 days \n\n No state health insurance \n\n Pregnancy", - "brief_summary": "It's a pilot prospective opened multicentric randomised study. We measure the efficiency and the safety of a new concept of off-loading shoe (SANIDIAB) compared with an old one (BAROUK) to treat chronic diabetic foot ulcer which involved a high risks of amputation 64 diabetic patients with a plantar neuropathic ulcer of the fore foot without infection, osteomyelitis or angiopathy, will be included. 32 patients will be treated with SANIDIAB shoe and 32 with BAROUK shoe", - "NCTID": "NCT01586481" - }, - { - "brief_title": "Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers", - "phase": "Phase 3", - "drugs": "['Gentamicin Collagen sponge', 'Placebo']", - "drugs_list": [ - "Gentamicin Collagen sponge", - "Placebo" - ], - "diseases": "['Foot Ulcer, Diabetic', 'Infection']", - "diseases_list": [ - "Foot Ulcer", - "Diabetic", - "Infection" - ], - "enrollment": "524.0", - "inclusion_criteria": "Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria. \n\n Has at least 1 skin ulcer located on or below the malleolus that presents with the following clinical manifestations of a moderate or severe infection based on the Infectious Disease Society of America guidelines for the Diagnosis and Treatment of Diabetic Foot Infections (CID 2012; 54:132-173) (IDSA guidelines): \n\n has \u2265 2 manifestations of inflammation (local swelling or induration, erythema, local tenderness or pain, local warmth, purulent discharge (thick, opaque to white or sanguineous secretion) \n\n has \u2265 1 of the following characteristics: erythema > 2cm, or involving structures deeper than skin and subcutaneous tissues (e.g. abscess, osteomyelitis, septic arthritis, fasciitis) For patients with multiple infected ulcers, the ulcer with the highest Diabetic Foot Infection Wound score (DFI score) must be on or below the malleolus and all infected ulcers must be completely coverable using no more than 4 sponges (sponges cannot be cut). \n\n Has documented adequate arterial perfusion in the affected limb(s) (either palpable dorsalis pedis and posterior tibial pulses, or normal Doppler wave forms, a toe blood pressure \u2265 45 mm Hg or participation is approved by a vascular surgeon) \n\n Has received appropriate surgical intervention to remove all necrotic and infected bone if diagnosed with osteomyelitis. \n\n Has received appropriate surgical debridement to remove all gangrenous tissue. \n\n ", - "exclusion_criteria": ": \n\n Has a known history of hypersensitivity to gentamicin (or other aminoglycosides). \n\n Has a known or suspected hypersensitivity to bovine collagen. \n\n Has an ulcer infection which, based upon the patient's known history of hypersensitivity and/or as otherwise in the opinion of the investigator, cannot be adequately treated with at least one of the empiric systemic antibiotic regimens allowed by this protocol. \n\n Has an ulcer associated with prosthetic material or an implanted device. \n\n Has received any systemic or topical antibiotic therapy for any reason within 7 days of randomization unless it was administered to specifically treat the infected ulcer(s) and only within 36 hours of randomization. \n\n Requires or is likely to require treatment with any concomitant topical product or wound therapy before the first follow-up study visit. \n\n Is severely immunocompromised, or likely to become severely immunocompromised during the study, in the opinion of the investigator. \n\n Has a history of myasthenia gravis or other neurological condition where gentamicin use is contraindicated as determined by the investigator. \n\n Has a history of epilepsy. \n\n Has a history of alcohol or substance abuse in the past 12 months. \n\n Has an uncontrolled illness that, in the opinion of the investigator, is likely to cause the patient to be withdrawn from the trial or would otherwise interfere with interpreting the results of the study", - "brief_summary": "This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with either (A) daily application of a gentamicin-sponge, (B) daily application of a placebo-sponge or (C) no-sponge, in the ratio 2:1:1. Patients will be treated for approximately 28 days and return to the clinic weekly for safety and efficacy assessments. After completing treatment, patients will return to the clinic for scheduled follow-up visits approximately 10, 30, 60 and 90 days after treatment is stopped.", - "NCTID": "NCT02447172" - }, - { - "brief_title": "Comparative Study of a Smartphone-Linked Self-Monitoring System Versus a Traditional One for Improving Metabolic Control and Compliance to Self-Monitoring of Blood Glucose", - "phase": "Phase 3", - "drugs": "['iBGStar', 'Traditional Glucometer']", - "drugs_list": [ - "iBGStar", - "Traditional Glucometer" - ], - "diseases": "['Diabetes Mellitus']", - "diseases_list": [ - "Diabetes Mellitus" - ], - "enrollment": "186.0", - "inclusion_criteria": "inclusion criteria: \n\n Type 1 diabetes \n\n Males and females \n\n Age between 14-24 years \n\n Any diabetes duration \n\n Cared for by the diabetes center for at least 1 year \n\n HbA1c \u2265 8% \n\n Basal bolus treatment (any insulin) \n\n Poor compliance with Self-Monitoring of Blood Glucose (less than 30% of the recommended Blood Glucose measurements recorded in the glucose meter in the two previous weeks, i.e. <16 Blood Glucose measurements in the last two weeks) \n\n Written informed consent obtained from patient or legal representative (for minor) \n\n ", - "exclusion_criteria": ": \n\n Treatment with other insulin regimen or Continuous Subcutaneous Insulin Infusion \n\n Refusal or inability to give informed consent to participate in the study \n\n Patients with short life expectancy \n\n Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint according to physician's judgment \n\n Requirement for concomitant treatment that could bias primary evaluation \n\n Patients with high likelihood of being unavailable for 6 and/or 12 months visits \n\n Subject is the investigator, sub-investigator, research assistant, pharmacist, study coordinator, other study site staff or relative of study site staff thus considered directly involved in the conduct of the study \n\n Current addition/abuse of alcohol or drugs \n\n Severe visual or dexterity impairment \n\n Patients with any mental condition rendering them unable to understand the nature, scope, and possible consequences of the study \n\n Pregnant or breast-feeding women \n\n Subjects unlikely or unable to comply with the Protocol requirements", - "brief_summary": "The purpose of this study is to demonstrate the superiority of iBGstar as a component of the diabetes treatment vs. traditional blood glucose self-monitoring system for improving glycemic control after 6 months in young patients with type 1 diabetes. The study is intended also to demonstrate the superiority of iBGStar as a component of the diabetes treatment vs. usual blood glucose self-monitoring system for improving the compliance to self monitoring of blood glucose after 6 months.", - "NCTID": "NCT02073188" - }, - { - "brief_title": "A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers", - "phase": "", - "drugs": "['Wound Dressing', 'Wound Dressing']", - "drugs_list": [ - "Wound Dressing", - "Wound Dressing" - ], - "diseases": "['Foot Ulcer, Diabetic']", - "diseases_list": [ - "Foot Ulcer", - "Diabetic" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Is the subject 18 years of age or older? \n\n Does the subject have a chronic full thickness diabetic foot ulcer (DFU) inferior to the malleolus that has been present for a minimum of four (4) weeks? \n\n Does the diabetic foot ulcer measure greater than 1.0 cm2 and less than 25.0 cm2 after the wound is debrided? \n\n Does the subject show evidence of neuropathy? \n\n Is the subject's wound free of tunneling and showing no exposed periosteum or bone and free of clinical infection defined as the presence of local signs and symptoms including purulence, warmth, tenderness, pain, induration, cellulitis, bullae, crepitus, abscess, fasciitis and osteomyelitis? \n\n Is the study wound able to be off loaded or achieve pressure relief and permit daily dressing changes? \n\n Is the subject willing to have three (3) wound biopsies taken (Visit 0, 4 and 8)? \n\n Is the subject willing to have photos taken of their wound and permit use of the photos in publications? \n\n Has the subject or their legally authorized representative signed an Institutional Review Board approved informed consent document and authorized the use and disclosure of protected health information? \n\n Does the subject have adequate circulation to the foot as evidenced by an Ankle Brachial Index (ABI) of 0.8 - 1.2; or if the ABI is greater than 1.2, does the subject show toe pressures >40 mmHg, or transcutaneous oximetry (TcPO2) > 40 mm Hg, or does the subject show adequate circulation on an arterial Doppler study? (ABI or Doppler results must be < 45 days old.) \n\n Is the subject able to comply with the protocol requirements? \n\n If the subject is a woman of child bearing potential is she practicing an acceptable form of birth control as determined by the Investigator, and is she willing to have a pregnancy test? \n\n ", - "exclusion_criteria": ": \n\n Is the subject pregnant or breast feeding or have they given birth within the 3 weeks preceding the screening visit? \n\n Has the subject been diagnosed with a malignant disease and received chemotherapy or treatment for a malignancy within the past 1 year? \n\n Does the subject have an infection requiring systemic antibiotic treatment? \n\n Has the subject ever received radiation therapy or other local therapy for malignancy at the extremity where the wound is located (from patient history)? \n\n Is the subject currently using systemic steroids, or have they used systemic steroids within the previous 2 weeks, or are they projected to require systemic steroid use during the study as evidenced by a history of chronic systemic steroid use? (Topical steroids (except on the study extremity) and steroid inhalants will be allowed in the study.) \n\n Does the subject have Lupus or Crohn's disease? \n\n Does the subject have an oxygen dependency? \n\n Has the subject received hyperbaric oxygen therapy within the previous 90 days? \n\n Has the subject had vascular surgery relating to the wound within 30 days prior to the Screening Visit? \n\n Does the subject have an active Charcot foot deformity of the foot presenting the ulcer? \n\n Has the subject received Dermagraft\u00ae, Apligraf, or any other biologically active wound care product, or used Regranex Gel\u00ae, KGF, TGF\u03b2 or another topical growth factor to the study ulcer within the 30 days prior to the Screening visit? \n\n Does the subject's wound require the use of topical silver, topical antibiotics, enzymatic debridement agents or other topical agents? \n\n Has the subject been enrolled in any investigational study within 30 days of the Screening Visit? \n\n Does the subject have any medical condition that in the opinion of the investigator should exclude him/her from participating in the study? \n\n Has the subject received ultrasonic debridement or electrical stimulation within 7 days of the Screening Visit?", - "brief_summary": "The primary objective is to:~Assess the effect of the Non-adherent study dressing to 3M Tegaderm Matrix Dressing with PHI technology on wound healing in patients with a diabetic foot ulcer.~Secondary objectives are to:~Assess the adverse events that occur in subjects randomized to the investigational dressing in comparison to subjects randomized to the Tegaderm Matrix Dressing with PHI technology.~Assess the costs of using the investigational dressing compared to the Tegaderm Matrix Dressing with PHI technology.~Assess and compare the impact that these dressings have on patients' quality of life.~Assess the wound's biological response and pH to the study dressings.", - "NCTID": "NCT01013792" - }, - { - "brief_title": "Study of the Efficacy of PedyPhar\u00ae Ointment on the Diabetic Foot Ulcers", - "phase": "Phase 3", - "drugs": "['Royal Jelly and Panthenol (PedyPhar\u00ae Ointment)', 'Panthenol Ointment']", - "drugs_list": [ - "Royal Jelly and Panthenol (PedyPhar\u00ae Ointment)", - "Panthenol Ointment" - ], - "diseases": "['Diabetic Foot Ulcer']", - "diseases_list": [ - "Diabetic Foot Ulcer" - ], - "enrollment": "47.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult diabetic foot syndrome subjects over 18 years of age of any sex \n\n All stages of diabetic foot syndrome including Wagner stage 5 - Mid-foot gangrene only after appropriate surgical treatment. \n\n Patients suffering from type 1 or type 2 diabetes mellitus with diabetic foot syndrome. \n\n Stable metabolic and pharmacological control at recruitment and during the trial period. \n\n Adequate perfusion of lower limb as measured by HHD and confirmed by APSV. \n\n ", - "exclusion_criteria": ": \n\n Non-diabetic foot ulceration (traumatic, thermal ulceration etc) \n\n Diabetic foot syndrome graded 5 on Wagner's scale - hind foot gangrene only. \n\n Any pathological state or disease which can affect the development and outcomes of diabetic foot syndrome such as liver cell failure and renal failure \n\n Severe limb ischemia (by clinical assessment and HHD) unless re-vascularized. \n\n Presence of slough or sequestrum unless debrided. \n\n Hemoglobin less than 8 g/dl unless corrected. \n\n Those receiving NSAIDs, steroids or anti-mitotic drugs. \n\n Septicemia patients requiring urgent amputation.", - "brief_summary": "Clinical Trial Phase III-b~Study Sponsor:~European Egyptian Pharmaceutical Industries~Sample Size:~120 patients (60 per arm)~Study Population:~Patients with Diabetic foot ulcer of any stage after proper surgical treatment - if needed. Those patients will be recruited from patients attending the Diabetic foot Center at Faculty of Medicine - Alexandria University and the outpatient clinic at Faculty of Medicine, Cairo University.~Recruitment Period: 9 months~Dose application: thick layer of 2-3 mm applied to the dressing then dressing applied to the ulcer.~Endpoints: Complete healing of the ulcer OR 5 months of application of the ointment whichever comes first", - "NCTID": "NCT01531517" - }, - { - "brief_title": "Ultrasonic Wound Debridement vs. Standard Sharp Debridement", - "phase": "", - "drugs": "['Contact ultrasonic debridement device']", - "drugs_list": [ - "Contact ultrasonic debridement device" - ], - "diseases": "['Chronic Skin Ulcers']", - "diseases_list": [ - "Chronic Skin Ulcers" - ], - "enrollment": "75.0", - "inclusion_criteria": "inclusion criteria: \n\n Chronic wound needing debridement >3 cm2 \n\n Ulcer history >4mo \n\n Adequate arterial blood flow (ABI>0.7) \n\n Venous, Inflammatory, Pressure, Diabetic \n\n ", - "exclusion_criteria": ": \n\n Bleeding disorder \n\n ABI<0.7 \n\n Uncontrolled diabetes \n\n Taking systemic corticosteroids \n\n Chemotherapy \n\n Participating in another study \n\n Treatment with Apligraft, Dermagraft, or Regranex within 90 days", - "brief_summary": "A single center, randomized, parallel, clinical outcome trial to compare the rate of healing in chronic wounds debrided with either high energy ultrasonic debridement (with cavitation) or standard of care sharp debridement.", - "NCTID": "NCT01237392" - }, - { - "brief_title": "The Effects of Vacuum-Compression Therapy on the Healing of Diabetic Foot Ulcers", - "phase": "", - "drugs": "['Vasotrain-447']", - "drugs_list": [ - "Vasotrain-447" - ], - "diseases": "['Diabetic Foot Ulcer']", - "diseases_list": [ - "Diabetic Foot Ulcer" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n A diabetic foot ulcer corresponding to grade 2 \n\n No history of deep venous thrombosis and no hemorrhage in ulcer \n\n ", - "exclusion_criteria": ": \n\n Significant loss of protective sensation \n\n Hemorrhage during treatment \n\n Vertigo \n\n No completion of treatment", - "brief_summary": "the objective of this study is to evaluate the impact of vacuum-compression effects of Vasotrain on the diabetic foot ulcers using stereological method based on Cavalieri's principle in diabetic patients.", - "NCTID": "NCT00477022" - }, - { - "brief_title": "Encouraging Mail Order Pharmacy Use to Improve Outcomes and Reduce Disparities", - "phase": "", - "drugs": "['Standardized intervention', 'Usual care']", - "drugs_list": [ - "Standardized intervention", - "Usual care" - ], - "diseases": "['Diabetes Mellitus']", - "diseases_list": [ - "Diabetes Mellitus" - ], - "enrollment": "63012.0", - "inclusion_criteria": "inclusion criteria: \n\n Diabetes patients who are users of CVD risk factor medications (antihypertensive therapies, antihyperlipidemics therapies, and oral antihyperglycemic therapies), \n\n Diabetes patients considered to be poorly adherent to CVD risk factor medications within the prior 12 months \n\n Diabetes patients who have not used the mail order pharmacy to fill any prescribed medications at least once in the prior 12 months", - "exclusion_criteria": "", - "brief_summary": "The investigators propose a randomized encouragement trial to encourage use of the existing mail order pharmacy services among diabetes patients with poor adherence to CVD risk factor medications in 3 health care systems: Kaiser Permanente Northern California, Harvard Pilgrim, and Kaiser Permanente Hawaii.", - "NCTID": "NCT02621476" - }, - { - "brief_title": "A Randomized, Controlled Trial of Autologous Platelet Gel Treatment in Diabetic Foot Ulcers", - "phase": "Phase 4", - "drugs": "['Autologous Platelet Gel']", - "drugs_list": [ - "Autologous Platelet Gel" - ], - "diseases": "['Diabetic Foot Ulcer']", - "diseases_list": [ - "Diabetic Foot Ulcer" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient is greater than 18 years of age \n\n Patient has Type I or Type II Diabetes \n\n Patient must be able to understand English (self or translator) and give written, informed consent \n\n Patient has a plantar forefoot ulcer(s) beneath metatarsal head or toe ulcer which has been present for at least 4 weeks, and has received best practice care \n\n Evidence of adequate arterial perfusion: Toe plethysmography reading of \n\n 45 mmHg or Transcutaneous oxygen measurement of \u2265 30mmHg \n\n Patient is appropriately offloaded (contact cast, pneumatic walking cast) \n\n Infection and/or osteomyelitis have been ruled out or are being treated \n\n Patients must have a platelet count greater than150,000/mm3 \n\n Orthopedic assessment has been completed to rule out mechanical source of ulceration \n\n Patients with following skeletal deformities could be included - \n\n Tendoachillis contracture - after tendoachillis contracture lengthening has been done \n\n Charcot arthropathy with concurrent surgical intervention \n\n Toe deformities ( hallus valgus, significant claw toe deformities) with/after surgical intervention \n\n Major axial malalignment (hindfoot varus/valgas, pes planus, pes cavus) with/after surgical intervention \n\n Patients taking clopidogrel (Plavix) and aspirin could be included in the study. Patients taking aspirin for non medical reason will be asked to discontinue the medicine one week before the start of treatment. \n\n ", - "exclusion_criteria": ": \n\n TcPO2 <30 mmHg and/or toe plethysmography readings of less then 45 mmHg \n\n Limb ischemia requiring re-vascularization or impending amputation \n\n Untreated wound infection or osteomyelitis \n\n Bleeding disorders, hemophilia, sickle cell disease, thrombocytopenia,and leukemia or blood dyscrasias \n\n Anemia with hemoglobin level less than 100 g/L will be included as ", - "brief_summary": "Foot ulcers represent a significant common complication in patients with diabetes. Wound healing is a challenge. Some wounds do not respond to the best practices in wound care. Considerable effort has been directed at therapies to improve the rate of healing.~There are a variety of growth factors which have been used to stimulate wound healing. Human platelets are an autologous source of growth factors which probably can stimulate healing. Autologous platelet gel (APG) is prepared by centrifugation of autologous human whole blood. APG is rich in platelet growth factors. This study will investigate the potential improvement in wound healing with this material in diabetic foot ulcers.~This study will compare the use of autologous platelet gel ( study group) and standard care ( control group) in the treatment of diabetic plantar forefoot ulcers. This study will also compare the cost and quality of life in the two groups.~Objectives of the study:~To determine if topical APG (autologous platelet gel) is beneficial in the treatment of diabetic foot ulcers.~To determine if it will result in a faster rate of wound healing.~To determine if it will improve the quality of life in patients with diabetic foot ulcers.", - "NCTID": "NCT00338702" - }, - { - "brief_title": "Safety Trial of the RedDress Wound Care System (RD1) in Management of Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.", - "phase": "Phase 2", - "drugs": "['RedDress Wound Care System (RD1)']", - "drugs_list": [ - "RedDress Wound Care System (RD1)" - ], - "diseases": "['Neuropathic Diabetic Ulcer - Foot']", - "diseases_list": [ - "Neuropathic Diabetic Ulcer - Foot" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject is \u226518 years of age and has type 1 or 2 diabetes \n\n Texas grade 1a or 2a wound located distal to the malleolus (excluding ulcers between the toes but including those of the heel) and depth \u2264 5 mm with no exposed capsule, tendon or bone and no tunneling, undermining or sinus tracts \n\n Prior to inclusion of an ulcer in the study, each wound will be reviewed for eligibility by an independent assessor using a central online review process that includes images of the ulcer. \n\n For patients with potentially multiple eligible DFUs, the biggest ulcer will be chosen as the study ulcer. \n\n Ulcer size between 1 cm2 and 12 cm2 (post-debridement). \n\n Ulcer duration of \u2265 30 days. Time 0 for ulcer duration of \u2265 30 days is defined as the first day of screening (i.e., day -14). Subjects will need to meet all inclusion criteria, including lack of ulcer healing until day 0. \n\n Study ulcer separated from other ulcers by at least 2 cm. \n\n Ulcer or affected limb free of clinical signs of infection. (Subjects with wound infection at the screening visit may be treated and re-screened for participation in the study after eradication of the infection). \n\n Post-debridement, ulcer free of necrotic tissue. \n\n Subject has adequate vascular perfusion of the affected limb, as defined by at least one of the following: (a) Ankle-Brachial Index (ABI) \u2265 0.65 and \u2264 1.2; (b) toe pressure (plethysmography) > 50 mm Hg; (c) TcPO2 > 40 mm Hg; or (d) skin perfusion pressure (SPP) > 30 mm Hg. \n\n HbA1c \u2264 12.0% (diabetic patients) \n\n Demonstrated adequate offloading regimen. \n\n Subject must be willing to comply with the protocol including having blood drawn to create the RD1. \n\n Female subjects who are capable of conceiving and all males capable of insemination must use an acceptable form of contraception in order to participate in the study (acceptable forms of contraception include condoms for males and contraceptive pills or IUDs for women). \n\n ", - "exclusion_criteria": ": \n\n Ulcer not of neuropathic diabetic foot pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, or arterial etiology, or pressure ulcers.). \n\n Presence of underlying osteomyelitis. \n\n Patient with a proven sepsis established by a blood culture in the past 2 weeks, or confirmed active infection likely to interfere with trial, such as urine tract infection. \n\n History of alcohol or substance abuse, within the previous 2 months \n\n Subject has participated in another clinical trial involving a device or a systemically administered investigational study drug or treatment within 30 days of randomization visit. \n\n Subject is currently receiving (i.e., within the past 30 days) or scheduled to receive a medication or treatment which, in the opinion of the Investigator, is known to interfere with, or affect the rate and quality of, wound healing (e.g., systemic steroids, immunosuppressive therapy, autoimmune disease therapy, cytostatic therapy within the past 12 months, dialysis, radiation therapy to the foot, vascular surgery, angioplasty or thrombolysis). \n\n Subject has been treated with wound dressings that include growth factors, engineered tissues or skin substitutes (e.g., Regranex\u00ae, Dermagraft\u00ae, Apligraf\u00ae, GraftJacket\u00ae, OASIS\u00ae, Primatrix\u00ae, Matristem\u00ae, etc.) within 30 days of randomization or is scheduled to receive during the study. \n\n Subject has been treated with hyperbaric oxygen within 5 days of screening or is scheduled to receive during the study. \n\n Wound on a patient who has a life expectancy of less than 12 months. \n\n Subjects who are cognitively impaired and have a healthcare proxy or those who are cognitively impaired and clearly do not understand the contents of the informed consent form. \n\n Cannot withdraw blood in the required amount (up to 10 mL per week) technically. \n\n Known coagulation problems, abnormal thrombocytes level or if heparin is given intravenously. Patients who are taking coumadin, aspirin, or Plavix (clopidogrel) will not be excluded. \n\n Hemoglobin anemia (< 10 g/dL). \n\n Subject has a history of or any of the following intercurrent illnesses or conditions that would compromise the safety of the subject, or the normal wound healing process: \n\n End stage renal disease \n\n Immunosuppression. \n\n Severe malnutrition \n\n Liver disease \n\n Scleroderma \n\n Acquired immune deficiency disease (AIDS) or HIV positive \n\n Connective tissue disorder \n\n Exacerbation of sickle cell anemia \n\n If ulcer area decreases by \u2265 30% during the initial 2-week screening (\u00b1 2 days) and standard of care phase, or if the ulcer area increases \u2265 30%, subject will be excluded. \n\n Women who are pregnant or currently breast feeding.", - "brief_summary": "The purpose of this study is to assess the safety of the RedDress Wound Care System (RD1) in patients Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.", - "NCTID": "NCT01396837" - }, - { - "brief_title": "Randomized, Prospective Evaluation of the Toad Brace in Plantar Ulcer Off-loading and Healing", - "phase": "", - "drugs": "['Optimal Medical Therapy Debridement + Toad Brace', 'Optimal Medical Therapy - Debridement']", - "drugs_list": [ - "Optimal Medical Therapy Debridement + Toad Brace", - "Optimal Medical Therapy - Debridement" - ], - "diseases": "['Diabetic Foot', 'Pedal Ulcers']", - "diseases_list": [ - "Diabetic Foot", - "Pedal Ulcers" - ], - "enrollment": "74.0", - "inclusion_criteria": "inclusion criteria: \n\n Men or women >18 years old \n\n One or more foot ulcers without clinical evidence of osteomyelitis \n\n Diagnosis of Diabetes Mellitus* \n\n University of Texas Grade 1A, 1C, 2A, or 2C ulcer15 \n\n ABI >0.7 and Toe pressure >30mmHg \n\n ", - "exclusion_criteria": ": \n\n Limited life-expectancy \n\n Wounds on calf or shin that would be in contact with the TAG Brace \n\n Gangrene, active infection \n\n Osteomyelitis of the foot with the ulcer \n\n Chronically bedridden/Non ambulatory \n\n Unable to keep research appointments \n\n Wide spread malignancy or systemically immunocompromising disease \n\n Ipsilateral revascularization procedure within the last 30 days. \n\n Unreliable, unwilling or unable to comprehend informed consent", - "brief_summary": "The TOAD Medical Corporation Brace is a novel device that completely off-loads the foot and has been shown to heal ulcers at a rapid rate in preliminary experience in patients with plantar ulcers. This trial will attempt to show the efficacy of the Toad Brace and is based on the hypothesis that the Toad brace completely offloads the foot and hastens healing rates of diabetic ulcers. The trial will randomize 74 patients with diabetic pedal ulcers to the Toad Brace or conventional therapy. . Quantitative assessment of ulcer rate healing rates will be determined clinically and by blinded, computer-assisted planimetry of digital images over a 12 week period. The pressure on the plantar surface will be measured via a pressure sensor in a subset of patients. The trials will attempt to show markedly reduced pressure on the plantar surface and significantly higher ulcer healing rates with using the Toad Brace.", - "NCTID": "NCT02052817" - }, - { - "brief_title": "Improving Diabetic Foot Ulcers With Atorvastatin", - "phase": "Phase 2", - "drugs": "['Atorvastatin (10 mg or 80 mg)']", - "drugs_list": [ - "Atorvastatin (10 mg or 80 mg)" - ], - "diseases": "['Foot Ulcer', 'Diabetes']", - "diseases_list": [ - "Foot Ulcer", - "Diabetes" - ], - "enrollment": "13.0", - "inclusion_criteria": "inclusion criteria: \n\n Provision of a written informed consent at the enrolment visit \n\n Men or women above 30 years of age \n\n Fertile women need to take contraceptives or have to be sterilised \n\n Diagnosed with any diabetes mellitus type 1 or type 2 \n\n Present foot ulcer with an ulcer duration <= 12 months \n\n ", - "exclusion_criteria": ": \n\n Intolerance to statins at any time in the past. \n\n Unwillingness to participate \n\n A history of alcohol or drug abuse within the last 2 years \n\n Foot ulcer with the etiology from vasculitis, pyoderma gangrenosum, angiodermatitis necroticans (hypertensive ulcer), necrobiosis lipoidica, hydrostatic pressure/venous insufficiency or any neoplasms (basalioma, kaposis sarcoma, squamous cell carcinoma etc). \n\n History of drug-induced hepatitis or previous liver enzyme elevations (> 3 times the upper limit of normal) while taking statins. \n\n History of drug-induced creatine phosphokinase (CPK) > 3 times the upper limit of normal. \n\n Critical limb ischemia that requires re-vascularisation procedures within 2 months \n\n Brachial-ankle index < 0.5 \n\n Other serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the patient's safety or successful participation in the trial. \n\n Any clinically significant abnormality identified in the enrolment medical history, physical examination, laboratory test which, in the judgement of the investigator, would preclude safe completion of the study. \n\n Active liver disease or hepatic dysfunction defined as ALAT or ASAT elevations > 2 times the upper limit of normal or total bilirubin > 1.5 times the upper limit of normal. \n\n Pregnancy", - "brief_summary": "Lower limb complications are a substantial matter in the diabetic population and studies show that the annual incidence of foot ulcers ranges from 1.0-4.1% while the cumulative lifetime incidence is approximately 15%. Foot ulcers may become complicated by infection or gangrene, and ultimately result in amputation. In addition, foot ulcers have a significant impact on quality of life (QoL). The treatment of diabetic foot ulcers has not made substantial progress in recent years with regards to improved healing although there have been several actions taken to update the process. The current practice consists of wound debridement, treatment of underlying infections and pressure relief. This trial investigates the adjunctive effects of high (80 mg) or low (10 mg) dose atorvastatin to conventional treatment on the healing of diabetic foot ulcers.", - "NCTID": "NCT00134550" - }, - { - "brief_title": "Trial of Herb Yuyang Ointment to Diabetic Foot Ulcer", - "phase": "Phase 2", - "drugs": "['herb ointment']", - "drugs_list": [ - "herb ointment" - ], - "diseases": "['Diabetic Foot Ulcer']", - "diseases_list": [ - "Diabetic Foot Ulcer" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n In-patient or out-patient patients diagnosed with diabetic foot ulcers \n\n Gangrene or ulceration occurred more than 3 weeks \n\n Over 18 years of age \n\n Gender-open \n\n The type of diabetes (type 1 or type 2) open \n\n Patients receive a written informed consent to participate in the trial \n\n ", - "exclusion_criteria": ": \n\n Serious complications of heart, liver, lung, kidney damage \n\n Malignant tumors \n\n Allergy for Chinese medicine used \n\n Pregnant women and breast-feeding women", - "brief_summary": "The purpose of this study is to determine if dressing change with a kind of herb Yuyang ointment is clinically more efficacious and safer than Conventional treatment in the treatment of diabetic foot ulcers.", - "NCTID": "NCT00839865" - }, - { - "brief_title": "Evaluation of Integra\u00ae Artificial Dermis for the Treatment of Leg Ulcers", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Lower Limb Ulcer']", - "diseases_list": [ - "Lower Limb Ulcer" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n patient with a lower limb ulcer, regardless of origin (arterial, venous or mixed, diabetic foot ulcer) present for more than 6 months or large in size (> 10 cm\u00b2) \n\n patients in whom the surgeon has recommended that an Integra\u00ae matrix be implanted (even if the patient is not taking part in the study) before the dermo-epidermal graft to obtain a richly vascularised neodermis. \n\n not eligible for skin flap surgery, \n\n the patient or patient's representative has agreed to sign the information letter before any investigation required by the research. \n\n ", - "exclusion_criteria": ": \n\n circumferential wound, \n\n wound infection \n\n immunosuppressed patient, \n\n known allergy to bovine collagen, bovine glycosaminoglycans or silicone, \n\n patients under legal guardianship, \n\n pregnant women \n\n patients whose health would compromise follow-up for at least 18 months, \n\n patients whose mental health would compromise completion of the self-evaluation questionnaires. \n\n wound located in an area not visible by the patient (as no self-assessment would be possible).", - "brief_summary": "The aim of this prospective study is to assess the utility of treatment of leg ulcers using a skin substitute, Integra\u00ae, assessing the quality of wound skin healing and transcutaneous oxygen pressure in the distal region of the wound.~This is a multi-centre study on 60 patients who have a lower limb ulcer.", - "NCTID": "NCT01285973" - }, - { - "brief_title": "Evaluate the Impact of Drawtex in Venous Leg Ulcers", - "phase": "", - "drugs": "['Drawtex dressing']", - "drugs_list": [ - "Drawtex dressing" - ], - "diseases": "['Moderatley to Highly Exuding Venous Leg Ulcers']", - "diseases_list": [ - "Moderatley to Highly Exuding Venous Leg Ulcers" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject > 18 years. \n\n Subject is attending weekly office visits at SW Wound Care Center as an out-patient. \n\n Subject has a moderately to highly exudative venous leg ulcer that would be indicated for treatment with Drawtex \n\n Subject or is informed about the trial, understands its nature of the study and provides written informed consent prior to study enrollment. \n\n Subject is willing and able to comply with all specified care and visit requirements \n\n ", - "exclusion_criteria": ": \n\n Subject has a lesion that does not meet the inclusion criteria. \n\n Subject refuses to participate in the study. \n\n Subject already participates in the this study with one wound (only one wound per subject is allowed) \n\n Subject has known sensitivity to the trial product or any of its compounds. \n\n Subject is expected to be non-compliant. \n\n Subject's lesion is a primary skin cancer. \n\n Subject's lesion is the manifestation of a metastasis. \n\n Subject is pregnant.", - "brief_summary": "This is a clinical study to comparatively evaluate the impact of Drawtex wound dressing against wound bioburden in moderately to highly exuding venous leg ulcers.", - "NCTID": "NCT01319123" - }, - { - "brief_title": "Evaluation of Low Source of Signal in SCOUT DS", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Metabolic Syndrome', 'Impaired Glucose Tolerance', 'Gestational Diabetes']", - "diseases_list": [ - "Metabolic Syndrome", - "Impaired Glucose Tolerance", - "Gestational Diabetes" - ], - "enrollment": "196.0", - "inclusion_criteria": "inclusion criteria: \n\n Dark Skin Tone (Von Luschan chromatic skin color > 35) \n\n Age greater than or equal to 45 years; \n\n OR \n\n Age 18 to 44 years and a BMI > 25 kg/m\u00b2 with one or more of the following diabetes risk factors: \n\n Habitually physically inactive (less than 30 minutes of moderate physical activity most, if not all, days of the week) \n\n Has a first-degree relative with type 2 diabetes \n\n African American, Latino, Native American, Asian American, Pacific Islander \n\n Has delivered a baby weighing > 9 lb or previously diagnosed with gestational diabetes \n\n Hypertension (\u2265140/\u2265 90 mmHg) or being treated for hypertension \n\n HDL cholesterol level < 35 mg/dL and/or a fasting triglyceride level \u2265 250 mg/dL or being treated for dyslipidemia with medication \n\n Has been previously diagnosed with Polycystic Ovary Syndrome (PCOS) \n\n Had impaired glucose tolerance or impaired fasting glucose on previous testing within the last 3 years \n\n Conditions associated with insulin resistance such as severe obesity or acanthosis nigricans \n\n History of vascular disease including heart attack, stroke, angina, coronary heart disease, atherosclerosis, congestive heart failure or peripheral arterial disease \n\n ", - "exclusion_criteria": ": \n\n Prior participation under VeraLight protocols: VL-2710, VL-2711 or VL-2712 \n\n Under 18 years of age \n\n Receiving investigational treatments in the past 14 days \n\n Psychosocial issues that interfere with an ability to follow study procedures \n\n Conditions that cause secondary diabetes including Cushing's syndrome, acromegaly, hemochromatosis, pancreatitis, or cystic fibrosis \n\n Diagnosed with any type of diabetes, including type 1 or 2 \n\n Taking glucose lowering medications \n\n Known to be pregnant \n\n Receiving dialysis or having known renal compromise \n\n Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm. \n\n Recent (within past month) or current oral steroid therapy or topical steroids applied to the left forearm; inhaled steroid therapy is not excluded \n\n Current chemotherapy, or chemotherapy within the past 12 months \n\n Receiving medications that fluoresce* \n\n Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity) \n\n Known to have, or at risk for, sensitivity to skin lotions or shaving (creams, lotions, soap, shaving cream) \n\n Prior bariatric surgery", - "brief_summary": "The overall objective of this study is to increase the number of dark skin tone individuals in the data set and evaluate if this increase in dark skin tone data has an impact on the accuracy of the SCOUT DS Diabetes Risk Score (DRS).", - "NCTID": "NCT01339637" - }, - { - "brief_title": "Pressure-Sensing Insoles in the Neuropathic Ulcer Treatment Pathway", - "phase": "", - "drugs": "['SurroSense Rx System']", - "drugs_list": [ - "SurroSense Rx System" - ], - "diseases": "['Diabetes', 'Diabetes Complications', 'Neuropathy', 'Peripheral Neuropathy', 'Diabetic Foot Ulcer']", - "diseases_list": [ - "Diabetes", - "Diabetes Complications", - "Neuropathy", - "Peripheral Neuropathy", - "Diabetic Foot Ulcer" - ], - "enrollment": "42.0", - "inclusion_criteria": "inclusion criteria: \n\n Diabetes (according to AAFP diagnostic criteria ) \n\n Presence of neuropathy with Loss of Protective Sensation (LOPS), as defined by any loss of sensation as per the assessments included in the Modified Neuropathy Disability Score (MNDS) \n\n Active plantar diabetic foot ulcer (Grade 1A, according to the University of Texas Wound Classification System , ) \n\n A minimum size ulcer \u22650.5cm2 and \u2264 12 cm2 post debridement at time of randomization \n\n If the subject has more than one ulcer, they should be identified and at least 2 cm apart \n\n Age >18 \n\n At least one palpable foot pulse \n\n Ability to understand all of the study requirements \n\n Life expectancy greater than the duration of the study \n\n Subject or responsible caregiver is willing and able to maintain the required offloading (as applicable for the location of the ulcer) and applicable dressing changes \n\n Doppler Ultrasound positive for at least one pedal pulse in each foot \n\n ", - "exclusion_criteria": ": \n\n Weight > 400 lb (182 kg) \n\n Uncorrected visual impairment \n\n Active Infection \n\n Non-plantar ulcers on the ankle, posterior heel, or other location \n\n More than one active plantar ulcer \n\n Presence of severe ischemia (any of: absence of foot pulses, Ankle Brachial Index 0.6 > [ABI] > 1.2, capillary refill time > 5 seconds; see Appendix 3) \n\n Current participation in another clinical investigation of a medical device or a drug; or has participated in such a study within 30 days prior to this study \n\n Current smokers \n\n Active abuse of alcohol \n\n o Subject has a history of any of the following intercurrent illnesses or conditions that would compromise the safety of the subject or the normal healing process: \n\n End-stage renal disease \n\n Immunosuppression \n\n Severe malnutrition \n\n Liver disease \n\n Aplastic anemia \n\n Scleroderma \n\n Acquired immune deficiency disease (AIDS) or HIV positive \n\n Connective tissue disorder \n\n Exacerbation of sickle cell anemia \n\n Active Charcot foot \n\n Excessive lymphedema \n\n Osteomyelitis and gangrene \n\n Subjects with ulcers secondary to a disease other than diabetes (e.g. vasculitis, neoplasms or haematological disorders) \n\n o At the end of the run-in period and prior to randomization, the subject be excluded if the following conditions are not met: \n\n Subject does not continue to meet the entrance criteria (inclusion and exclusion) \n\n The size of the study ulcer, following debridement, has decreased by more than 30% from the baseline assessment measured at screening. \n\n Abnormal toe and/or ankle range of motion", - "brief_summary": "Diabetic foot ulceration (DFU) is a common complication with a 25% lifetime risk in patients with diabetes. While most of these ulcers can be treated successfully on an outpatient basis, some will persist and become infected. Nearly one fifth of patients with lower-extremity diabetic ulcers will require amputation of the affected limb, resulting in staggering costs for both the patient and the healthcare system. Therapies that promote rapid and complete healing and reduce the need for expensive surgical procedures impact these costs substantially.~The standard of care for the treatment of diabetic foot ulcers is the removable cast walker (RCW). RCW use has demonstrated plantar pressure reduction yet is typically perceived as having compliance issues due to its removable nature. In addressing this limitation, a modified version of the RCW has been developed by wrapping it in a layer of cohesive or plaster bandage. This technique has been termed the instant total contact cast (iTCC) derived from the seldom-used, gold standard treatment, the total contact cast (TCC). While ease of application and potential clinical equivalence are clear benefits, the iTCC carries disadvantages on account of its irremovability. For example, frequent dressing changes impractical, yet may be necessary for complex wound care. The goal of this research is to continue inquiry and innovation in this most basic aspect of care, whilst addressing the limitations of past research and failures in this domain.~The investigators propose examining the capability of the SurroSense Rx\u00ae smart insole and smartwatch system (Orpyx Medical Technologies Inc., Calgary AB) in managing and monitoring adherence to plantar pressure offloading through alert-based feedback. The insoles are embedded with pressure sensors, which wirelessly communicate with a smartwatch that provides feedback on modifying activity or pressure profile over time. This smartwatch transmits audio, visual, and tactile notifications when excessive pressure-time thresholds under plantar regions of interest have been met. This feedback allows patients to be educated on their plantar pressure, and engages them and their caregivers to manage adherence to offloading. The investigators also propose comparing the healing rates of active neuropathic ulcers using RCWs coupled with the SurroSense Rx\u00ae smart insole system to assess whether adjunctive use of the two interventions improves the efficiency of neuropathic ulcer treatment.", - "NCTID": "NCT02586519" - }, - { - "brief_title": "A Pilot Study of the WoundWand\u2122 Debridement Device on Infection Prevention", - "phase": "", - "drugs": "['WoundWand\u2122 Debridement Device', 'Standard of Care sharp debridement']", - "drugs_list": [ - "WoundWand\u2122 Debridement Device", - "Standard of Care sharp debridement" - ], - "diseases": "['Lower Leg Wound']", - "diseases_list": [ - "Lower Leg Wound" - ], - "enrollment": "11.0", - "inclusion_criteria": "inclusion criteria \n\n Subjects who meet the following criteria may be included in the clinical investigation, if they present with ALL of the following: \n\n Subject is able to understand the evaluation and willing to consent and comply with all post-debridement visits and procedures \n\n Age 18 years and older. Subjects may be of either sex and of any race or skin type \n\n Subjects fulfilling any one or all of the following criteria: \n\n chronic wound(s) below the level of the knee, defined by delayed healing or cellular senescence \n\n acute wound(s) as a result of a surgical procedure, laceration, abrasion or trauma \n\n diabetic foot ulcer(s) \n\n subjects with venous leg ulcers below the knee on the leg or foot with one or more documented failure of maximal medical therapy for their study wound >30 days such as compression bandages (low elasticity, elastic, multilayered, elastic and non elastic compression) \n\n Subjects with the following lab results within 30 days of treatment: \n\n serum albumin level >20g/L \n\n clinically non significant results of liver function test (LFTs), serum glucose and complete blood count (CBC) with differential \n\n Subjects with a Braden Score \u226513-14 (Moderate Risk) \n\n Subjects with adequate arterial blood flow [Ankle-Brachial Index (ABI) >0.75] \n\n ", - "exclusion_criteria": " \n\n Subjects will be excluded from the clinical investigation, if they present with ANY of the following: \n\n Subjects that have tunneling wounds \n\n Subject presents with an active infection in the study wound, as defined by purulence and: \n\n Fever and leukocytosis \n\n OR any TWO of the following: \n\n Malodor, pain or tenderness, warmth, erythema, induration, swelling, lymphangitis \n\n Infected bone diagnosed by imaging modality (e.g., Magnetic Resonance Imaging (MRI) and/or radiographic images) \n\n Subjects whose study wound does not require debridement \n\n Cardiac pacemaker or other electronic implant(s) \n\n Subjects with irradiate, burn or ischaemic wounds or history of keloids \n\n Subjects with vasculitis, non-reconstructive peripheral vascular disease, pyoderma gangrenosum, renal failure or lymphoedema \n\n Subjects with uncontrolled bleeding disorder (PT/PTT) and coagulopathy (including those with hemophilia) \n\n Subjects taking treatment with any of the following: \n\n Systemic corticosteroids \n\n Immunosuppressive agent(s) \n\n Chemotherapy or Radiation therapy \n\n Subjects deemed to require biologic dressing/ skin substitute \n\n Terminally ill subjects \n\n Subjects that have an immunodeficiency disorder that interferes with wound healing, including Acquired Immunodeficiency Syndrome (AIDS) or know to be infected with Human Immunodeficiency Virus (HIV) \n\n Subjects that have chronic skin conditions such as psoriasis, etc. \n\n Subjects that reside in a nursing home \n\n Subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.) to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant \n\n Subject is pregnant and/or intending to become pregnant during this clinical investigation period \n\n Subject has documented evidence of a history (e.g. liver testing) of drug/alcohol abuse within the 12 months prior to enrollment for clinical investigation entry \n\n Subject is excluded if they have received an investigational therapy or approved therapy for investigational use within 30 days of surgery \n\n Subject is excluded if planning to participate in another research study during the follow-up phase of this study or 84 days after study completion", - "brief_summary": "A Pilot Study of the WoundWand\u2122 Debridement Device on Infection Prevention", - "NCTID": "NCT01924806" - }, - { - "brief_title": "Larval Debridement Therapy Versus Sharp Debridement to Remove Biofilm", - "phase": "", - "drugs": "['Larval Debridement Therapy', 'Bedside Sharp Debridement']", - "drugs_list": [ - "Larval Debridement Therapy", - "Bedside Sharp Debridement" - ], - "diseases": "['Lower Extremity or Diabetic Foot Ulcers', 'Bacterial Infection']", - "diseases_list": [ - "Lower Extremity or Diabetic Foot Ulcers", - "Bacterial Infection" - ], - "enrollment": "45.0", - "inclusion_criteria": "inclusion criteria: \n\n Veterans over 21 years of age \n\n with chronic lower extremity or diabetic foot ulcers (wound duration over 8 weeks) \n\n who at the clinician's judgment requires wound debridement (25% or more of wound bed covered with non-viable tissue) \n\n wound size 1.5 cm (roughly the size of a quarter) or larger in diameter \n\n ", - "exclusion_criteria": ": \n\n Cognitive impairment that would interfere with patient signing own Informed Consent \n\n Veterans on active anticoagulant therapy with most recent (within last week) PT/INR (international normalized ratio of prothrombin time) > 3.0, or other significant bleeding risk \n\n Active immune suppression just prior to or during study (on systemic corticosteroids* within 7 days prior, or chemotherapy for cancer or RA treatment within 4 weeks prior to study, or with diagnosis of HIV/AIDS) - *Nasal steroid sprays will not be excluded \n\n Active systemic antibiotics is an exclusion \n\n Absent dorsalis pedis pulses and Ankle Brachial Index (ABI) < 0.5 is an exclusion (indicates critical limb ischemia). \n\n Other possible reasons participants could be removed from this study include: transfers to other non-VA facilities, participant is unable to tolerate tissue sampling even with local anesthesia, and/or inability to comply with scheduled research visits. Furthermore, if the participant has significant wound healing so that sampling is not possible after the initial sampling, they will be removed from the study.", - "brief_summary": "This is a prospective study of Veterans with chronic lower extremity or diabetic foot ulcers who will be randomized to either a Larval Debridement Therapy group (Biobags every 4 days x 2 applications) or a Sharp Debridement Therapy group (standard or control weekly x 2) during an 8 day study period.", - "NCTID": "NCT02294175" - }, - { - "brief_title": "Evaluation of the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Full-Thickness, Neuropathic Diabetic Foot Ulcers", - "phase": "Phase 4", - "drugs": "['Collagen ORC Antimicrobial Matrix (CAM)']", - "drugs_list": [ - "Collagen ORC Antimicrobial Matrix (CAM)" - ], - "diseases": "['Foot Ulcer']", - "diseases_list": [ - "Foot Ulcer" - ], - "enrollment": "48.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years of age or older. \n\n Ambulatory (i.e. walking is the primary method of mobilization. Crutches, walker, walking frame or other ambulation aids are permitted). \n\n Diagnosed Type 2 diabetic (i.e. not juvenile onset). \n\n Have a DFU on the plantar surface of either foot. \n\n Have a DFU of >4 wks but <6 months duration. \n\n Willing and capable of cooperating to the extent and degree required by the study protocol \n\n ", - "exclusion_criteria": ": \n\n Be < 1cm2 or >10cm2 in area, by planimetry. \n\n Demonstrate overt signs of infection. \n\n Be located on the dorsal, lateral, or posterior heel area of the foot (Change 2, Amendment 1). \n\n Have visible exposed bone or tendon. \n\n Have an adjacent thermal injury or wound of an etiology other than diabetes. \n\n Be within 5 cm of any other wound, regardless of etiology. \n\n Have received enzymatic debriding agents in the past 7 days. \n\n Have received topical antibiotic therapy in the past 7 days. \n\n Be less than 1 cm2 or exceed 10cm2 in area by planimetry, after debridement. \n\n Have exposed bone or tendon, after debridement \n\n The study subject MUST NOT: \n\n Have received previous treatment for the study ulcer by this Investigator. \n\n Have more than 3 full thickness ulcers, in total. \n\n Be pregnant or nursing an infant \n\n Have a concurrent illness or condition which may interfere with wound healing, such as carcinoma, vasculitis, immune system disorders or connective tissue disorder. \n\n Be a known alcohol or drug abuser. \n\n Have received systemic corticosteroids, immunosuppressive or chemotherapeutic agents in the past 30 days. \n\n Have received radiotherapy, which includes the lower extremity, at any time. \n\n Have a marked Charcot foot or claw foot deformity which would limit the ability of the subject to wear or be compliant with the wearing of the standardized off-loading device used in this study. \n\n Have received an investigational drug or device in the past 30 days. \n\n Have a known hypersensitivity to bovine collagen, oxidized regenerated cellulose (ORC) or silver. \n\n Be unwilling or unable to be fitted or compliant with the wearing of an ulcer off-loading device. \n\n Known to be non-compliant or unlikely to complete the study. \n\n Have ABPI < 0.7, OR, if ABPI >1.0 and toe pressure >0.6. \n\n Have serum Creatinine > 3 mg/dL25. have Hgb A1C>9%", - "brief_summary": "This is a randomized (1:1), prospective, open label, multicenter, comparative study to be examine the effectiveness of Collagen-ORC Antimicrobial matrix, a new wound dressing, on diabetic foot ulcers.", - "NCTID": "NCT00235196" - }, - { - "brief_title": "Removable Walker for Neuropathic Ulcers", - "phase": "Phase 3", - "drugs": "['non-removable fiberglass', 'Stabil-D\u00ae']", - "drugs_list": [ - "non-removable fiberglass", - "Stabil-D\u00ae" - ], - "diseases": "['Diabetic Foot']", - "diseases_list": [ - "Diabetic Foot" - ], - "enrollment": "48.0", - "inclusion_criteria": "inclusion criteria: \n\n The presence of neuropathic plantar ulcer with an area graded IA according to the Texas University classification, AND \n\n The presence of peripheral neuropathy. Peripheral neuropathy was diagnosed based on insensitivity to a 10-g Semmes-Weinstein monofilament in more than 6 out of 9 areas of the foot and by a vibration perception threshold measured by biothesiometer (Neurothesiometer SLS, Nottingham, UK) at the malleolus > 25 volts. \n\n ", - "exclusion_criteria": ": \n\n Presence of an ankle-brachial pressure index (ABI) < 0.9 and/or transcutaneous oxygen tension (TcPO2) < 50 mmHg tested on the dorsum of the foot, \n\n Presence of clinical signs of infection, including edema, erythema, increased local skin temperature, or drainage, \n\n The probe-to-bone maneuver was required to be negative, \n\n Tthe standard X-ray examination of the foot was required to be negative for osteomyelitis, \n\n Use of steroids or cytostatic drugs, \n\n Presence of sensory, motor, or visual problems that could impair functional autonomy, \n\n Active ulcer on the contralateral foot, \n\n Previous major amputation of the contralateral limb, \n\n Previous or current deep venous leg thrombosis, OR \n\n Mental disorders interfering with patient compliance.", - "brief_summary": "Objective: To evaluate the efficacy of removable cast walker compared to non-removable fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer~Research design and methods: Forty-five adult diabetic patients with non-ischemic, non-infected neuropathic plantar ulcer were randomized to treatment with a non-removable fiberglass off-bearing cast (TCC group) or walker cast (Stabil-D group). Treatment duration was 90 days. Percent reduction in ulcer surface area and total healing rates were evaluated after treatment.", - "NCTID": "NCT01005264" - }, - { - "brief_title": "TempTouch IR Thermometry & Diabetic Patient Self-Care", - "phase": "Phase 2; Phase 3", - "drugs": "['TempTouch\u00ae']", - "drugs_list": [ - "TempTouch\u00ae" - ], - "diseases": "['Diabetic Polyneuropathy', 'Diabetic Foot Ulcer', 'Diabetes', 'Foot Infection']", - "diseases_list": [ - "Diabetic Polyneuropathy", - "Diabetic Foot Ulcer", - "Diabetes", - "Foot Infection" - ], - "enrollment": "180.0", - "inclusion_criteria": "inclusion criteria: \n\n diagnosis of diabetes by WHO criteria \n\n ability to provide informed consent \n\n 18-80 years of age \n\n ", - "exclusion_criteria": ": \n\n patients with open ulcers or open amputation sites \n\n active Charcot arthropathy \n\n severe peripheral vascular disease \n\n active foot infection \n\n dementia -impaired cognitive function- \n\n history of drug or alcohol abuse within one year of the study \n\n other conditions based on the PI's clinical judgment", - "brief_summary": "Foot ulcers develop in diabetics with neuropathy because of cumulative injury over the course of several days. These patients do not feel pain, and do not recognize their foot is being injured until a wound develops. Areas about to ulcerate become inflamed and hot spots can be identified. This study's purpose is to evaluate the effectiveness of a home infrared temperature probe designed to forewarn patients that an area on the foot is inflamed so they can take preventive measures. The study will evaluate the incidence of diabetic foot ulcers among high-risk patients, evaluate the cost of home temperature monitoring compared to standard therapy, and evaluate patient satisfaction. 180 diabetics at high-risk of having foot complications will be randomized into 3 treatment arms: 1) standard therapy consisting of regular foot care; 2) standard therapy plus recording of a structured foot evaluation using a hand mirror; and 3) standard therapy plus infrared home temperature assessment to identify hot spots. Device patients will measure temperatures at 6 sites on the foot each day. When temperatures are elevated >4\u00b0F patients will contact the research nurse and decrease activity. The primary study outcome will be incident foot ulcers and Charcot fractures.", - "NCTID": "NCT00289497" - }, - { - "brief_title": "Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot Ulcers", - "phase": "Phase 3", - "drugs": "['Dermagraft', 'Comparator']", - "drugs_list": [ - "Dermagraft", - "Comparator" - ], - "diseases": "['Diabetic Foot Ulcer']", - "diseases_list": [ - "Diabetic Foot Ulcer" - ], - "enrollment": "314.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient is 18 years of age or older. \n\n Patient has type I or II diabetes. \n\n Foot ulcer has been present for a minimum of 2 weeks under the current investigator's care. \n\n Foot ulcer is on the plantar surface of the forefoot or heel. \n\n Ulcer size is >/=1.0 cm2 at Day 0 (day of randomization). \n\n Ulcer extends through the dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone, or joint capsule. \n\n Ulcer is free of necrotic debris, exhibits no signs of clinical infection, and appears to be made up of healthy vascularized tissue. \n\n Patient's Ankle-Arm Index by Doppler is >/=0.7. \n\n Patient has adequate circulation to the foot as evidenced by a palpable pulse. \n\n Female patients of child bearing potential must not be pregnant and must use accepted means of birth control. \n\n Patient and caregiver are willing to participate in the clinical study and can comply with the follow-up regimen. \n\n Patient or his/her legal representative has read and signed the Institutional Review Board (IRB) approved Informed Consent form before treatment. \n\n Patient's study ulcer has been present (open) for at least 6 weeks at the time of the Screening visit. \n\n ", - "exclusion_criteria": ": \n\n There is clinical evidence of gangrene on any part of the affected foot. \n\n The study ulcer is over a Charcot deformity. \n\n The study ulcer is due to a nondiabetic etiology. \n\n The ulcer has tunnels or sinus tracts that cannot be completely debrided. \n\n The ulcer is >20 cm2 (longest dimension cannot be greater than 5 cm). \n\n The ulcer has increased or decreased in size by 50% or more during the screening period. \n\n Presence of medical condition(s) that in the Investigator's opinion makes the patient an inappropriate candidate for this study. \n\n Presence of a malignant disease not in remission for 5 years or more. \n\n Evidence of severe malnutrition, based on a serum albumin level <2.0. \n\n Presence of patient having known alcohol or drug abuse. \n\n A random blood sugar reading >/=450 mg/dL. \n\n Presence of urine ketones that are noted to be Small, Moderate, or Large. \n\n Presence of a nonstudy ulcer on the study foot within 7.0 cm of the study ulcer at Day 0. \n\n Use of oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, Coumadin or heparin during the study. \n\n A history of bleeding disorder. \n\n Presence of Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV). \n\n Participation in another study involving treatment with an investigational product within the previous 30 days. \n\n Elective osseous procedures to the study foot within 30 days prior to the Screening visit. \n\n Previous treatment with Dermagraft\u00ae. \n\n Presence in study ulcer of cellulitis, osteomyelitis or other clinical evidence of infection. \n\n Presence of condition(s) that seriously compromise the patient's ability to complete this study.", - "brief_summary": "This study randomly assigns patients with diabetic foot ulcers to receive standard therapy (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they heal or the 12-week treatment period is complete.", - "NCTID": "NCT01181453" - }, - { - "brief_title": "Biatain Ag vs Biatain in the Treament of Leg Ulcers", - "phase": "", - "drugs": "['Biatain Ag', 'Biatain']", - "drugs_list": [ - "Biatain Ag", - "Biatain" - ], - "diseases": "['Leg Ulcers']", - "diseases_list": [ - "Leg Ulcers" - ], - "enrollment": "182.0", - "inclusion_criteria": "inclusion criteria: \n\n \u2022 Patients over 18 who have given written informed consent \n\n Patients with a venous or predominantly venous leg ulcer (ankle-brachial index > 0.8) that is between 2 cm and 13 cm in all directions \n\n Patients with a moderately or severely exudating leg ulcer in the phase of debridement or formation of granulation tissue \n\n Patients with a leg ulcer that is not healing properly despite suitable and well-conducted local treatment in the four weeks prior to inclusion \n\n Patients with a leg ulcer that has been treated with appropriate compression in the four weeks prior to inclusion \n\n Patients who are available for monitoring for at least 10 weeks \n\n ", - "exclusion_criteria": ": \n\n \u2022 Patients whose leg ulcers are clinically infected (including erysipelas and cellulitis of the skin around the ulcer) requiring systemic antibiotic treatment \n\n Patients who have undergone surgery on the saphenous trunk within the two months prior to inclusion \n\n Patients whose leg ulcer being considered for the study has been treated with local antibiotics or antiseptics incl. dressings containing antibiotics or antiseptics in the four weeks prior to inclusion \n\n Patients who have been taking systemic antibiotics in the two weeks prior to inclusion \n\n Patients who have been taking systemic corticoids or cytostatics within the three months prior to inclusion \n\n Patients with unbalanced diabetes at the discretion of the investigator \n\n Patients with a known allergy to one of the components in Biatain Argent\u00ae or Biatain \n\n Patients who are already taking part in another clinical study \n\n Patients who are pregnant or breastfeeding", - "brief_summary": "the objective of this investigation is to demonstrate the effect of the foam dressing Biatain Ag, compared to Biatain foam dressing( a product which is similar but does not contain a silver complex, in the healing of leg ulcers that had failed to heal despite appropriate therapy", - "NCTID": "NCT00807664" - }, - { - "brief_title": "Effect of SACCHACHITIN on Healing of a Chronic Wound", - "phase": "Phase 2", - "drugs": "['SACCHACHITIN patch']", - "drugs_list": [ - "SACCHACHITIN patch" - ], - "diseases": "['Wounds']", - "diseases_list": [ - "Wounds" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with a poorly healed wound, in which skin graft is clinically indicated \n\n ", - "exclusion_criteria": ": \n\n Skin infection \n\n Vital signs unstable", - "brief_summary": "SACCHACHITIN gel, prepared from the waste residue of the fruiting body of Ganoderma tsugae, was used in a previous study to enhance skin wound healing in animal models. In the present study, the effects of the gel on the activity of matrix metalloproteinases (MMPs) and vascular endothelial growth factor (VEGF) as well as on the healing of skin wounds in humans are estimated by a clinical trial.~The hypothesis regarding the poor healing of the wound is the over-expression of MMP and the inhibition of the angiogenic factors. From the previous animal study, the effect of SACCHACHITIN was to inhibit the activity of MMP and stimulation of VEGF and we try to prove the effect over the human wounds from this clinical trial.~Patients with a poorly healed wound, in which skin graft is clinically indicated, are included in this study. The exudates from the wound are collected and analyzed for the activity and concentration of VEGF and MMP. The change of the healing process is recorded.~Positive results are expected from the clinical trial and the patients will get another choice for the treatment of the chronic wound other than skin grafting.", - "NCTID": "NCT00117364" - }, - { - "brief_title": "Study Comparing VERSAJET With Conventional Surgical Procedures in the Removal of Unhealthy Tissue From Lower Limb Ulcers", - "phase": "Phase 4", - "drugs": "['Versajet Hydrosurgery System', 'Conventional surgical debridement techniques']", - "drugs_list": [ - "Versajet Hydrosurgery System", - "Conventional surgical debridement techniques" - ], - "diseases": "['Diabetic Foot', 'Varicose Ulcer', 'Pressure Ulcer']", - "diseases_list": [ - "Diabetic Foot", - "Varicose Ulcer", - "Pressure Ulcer" - ], - "enrollment": "46.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who are at least 18 years of age. \n\n Males and females (provided they are not pregnant or, if of reproductive age, are using contraception). \n\n Patients with a venous stasis, diabetic foot or decubitus reference ulcer located between the tibia and foot. \n\n Patients undergoing surgical debridement of their reference ulcer in the operating room (OR). \n\n Patients undergoing their first surgical debridement of the reference ulcer. \n\n Patients suitable for debridement of their reference ulcer with both VERSAJET\u2122 and conventional debridement techniques. \n\n Patients who are able to understand the evaluation and are willing and able to provide written consent to participate in the evaluation. \n\n ", - "exclusion_criteria": ": \n\n Patients with clinical signs of infection in the reference ulcer (e.g. purulence and / or odour). \n\n Patients with haemophilia \n\n Patients who have been treated with topical steroids, systemic immunosuppressants (including corticosteroids), anticoagulants or cytotoxic chemotherapy in the last 30 days, or who are anticipated to require such medications during the course of the study. \n\n Patients known to have Acquired Immunodeficiency Syndrome (AIDS) or known to be infected with Human Immunodeficiency Virus (HIV). \n\n Patients who suffer from acute or chronic bacterial, viral or fungal skin diseases that would interfere with wound healing. \n\n Patients with a known history of poor compliance with medical treatment. \n\n Patients who have participated in this evaluation previously or are currently participating in another clinical study.", - "brief_summary": "The purpose of this study is to compare the VERSAJET\u2122 device with conventional surgical procedures (performed with a scalpel) in the debridement (removal of unhealthy tissue) of lower limb ulcers.~It is hypothesised that the time taken to debride lower limb ulcers will be quicker with the VERSAJET\u2122 device than with conventional surgical procedures.", - "NCTID": "NCT00521027" - }, - { - "brief_title": "VergenixTM Flowable Gel in Patients With Lower Limb Ulcers", - "phase": "", - "drugs": "['VergenixTM Flowable Gel']", - "drugs_list": [ - "VergenixTM Flowable Gel" - ], - "diseases": "['Lower Limb Ulcers']", - "diseases_list": [ - "Lower Limb Ulcers" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient is 18 years of age or older. \n\n 2. Patient has one of the following difficult-to-treat chronic ulcers in the \n\n lower limb: \n\n 2.1. Neuropathic lower limb ulcer \n\n 2.2. Venous lower limb ulcer \n\n 2.3. Post traumatic lower limb ulcer \n\n 2.4. Post operative lower limb ulcer \n\n 3. In case of Neuropathic foot grade according to University of Texas \n\n Classification 1A \n\n 4. Wound area measurement ranging between 1-20cm2. \n\n 5. Ulcer defined as grade \u2265E on the granulometer scale. \n\n 6. Willing to adhere to the proper off-loading device (off loading cast, \n\n healing shoe) according to investigator recommendation. \n\n 7. Female patients must have a negative serum pregnancy test at \n\n screening and be willing and able to use a medically acceptable \n\n method of birth control or declare that they are abstaining from sexual \n\n intercourse, from the screening visit through the study termination \n\n visit or be surgically sterile (bilateral tubal ligation, bilateral \n\n oophorectomy, or hysterectomy) or post-menopausal. Postmenopausal \n\n women are defined as women with menstruation cessation for \n\n 12 consecutive months prior to signing of the informed consent form. \n\n 8. Ability and willingness to understand and comply with study \n\n procedures and to give written informed consent prior to enrollment in \n\n the study. \n\n ", - "exclusion_criteria": ": \n\n Acute ulcer \n\n Multiple Ulcers on the lower limb. \n\n Clinical evidence of infection in the soft tissue, joint and/or bone \n\n (osteomyelitis) as presented in the physical examination. \n\n The wound is penetrating into deep structures and involves bone, \n\n tendon or joint. \n\n Wound has necrotic tissue. \n\n Wound with sinus tracts. \n\n HbA1c>12. \n\n Patients with any other skin disorder unrelated to the ulcer that is \n\n presented in adjacent to the target wound. \n\n Clinically significant arterial vascular disease with Ankle-Brachial Index (ABI) index <0.45 \n\n if the peripheral pulse is not palpable, or flatted Pulse Volume Recording (PVR) in case of non \n\n palpable arteries. \n\n Patient is receiving, or has received within one month prior to \n\n enrollment any treatment known to impair wound healing, including \n\n but not limited to:, immunosuppressive drugs, cytotoxic agents, \n\n radiation therapy and chemotherapy. \n\n Has active malignant disease of any kind. A patient, who has had a \n\n malignant disease in the past, was treated and is currently disease-free \n\n for at least 5 years, may be considered for study entry. \n\n Patients who present with significant metabolic co-morbidity that \n\n would preclude wound healing such as end stage renal failure, dialysis \n\n or severe liver dysfunction. \n\n Clinically significant abnormalities in hematology and blood \n\n chemistry lab tests at screening that in the opinion of the investigator \n\n might interfere with the patient's safety or participation in the study. \n\n Known positive HIV. \n\n Known history of a significant medical disorder, which in the \n\n investigator's judgment contraindicates the patient's participation. \n\n Known hypersensitivity and/or allergy to collagen. \n\n Drug or alcohol abuse (by history). \n\n Patients participating in any other clinical trials. \n\n Patients with inability to communicate well with the investigators and \n\n staff (i.e., language problem, poor mental development or impaired \n\n cerebral function).", - "brief_summary": "Vergenix Flowable Gel is indicated for the management of acute and chronic wounds", - "NCTID": "NCT02598180" - }, - { - "brief_title": "Comparison of Autologous Mesenchymal Stem Cells and Mononuclear Cells on Diabetic Critical Limb Ischemia and Foot Ulcer", - "phase": "Phase 1", - "drugs": "['Symptoms and Objective Examination']", - "drugs_list": [ - "Symptoms and Objective Examination" - ], - "diseases": "['Autologous Transplantation', 'Diabetic Foot']", - "diseases_list": [ - "Autologous Transplantation", - "Diabetic Foot" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Age from 40 to 70 years \n\n Type 2 diabetic patients \n\n bilateral critical limb ischemia(ABI from 0.30 to 0.60) \n\n at least with one foot ulcer \n\n ", - "exclusion_criteria": ": \n\n dry gangrene above the ankle or moist gangrene \n\n malignant tumor \n\n severe coronary,cerebral and renal vascular disease", - "brief_summary": "Objective:~To compare the effect and safety of autologous transplantation of bone marrow mesenchymal stem cells(MSCs) and mononuclear cells(MNCs) on Diabetic patients with Critical Limb Ischemia and Foot Ulcer.~Methods:~patients were randomized into the A group and the B group by use of a randomization table. One lower limb in A group or in B group was selected randomly for MSCs or MNCs transplantation as MSCs or MNCs group, the other lower limb in the same patient was selected for placebo\uff08normal saline ,NS\uff09injection as NS group.~The whole procedures of this clinical trial were blinded to both patients and investigators.Patients in both groups received the same ordinary treatment. Meanwhile, MSCs and MNCs were transplanted into the impaired lower limbs respectively. Follow-up index include: efficacy (pain,ulcer healing rate, lower limb amputation rate and ,ankle-brachial index,Transcutaneous oxygen pressure,magnetic resonance angiography) and safety (infection of the injection site, immunological rejection, and tumour generation).", - "NCTID": "NCT00955669" - }, - { - "brief_title": "The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Southern Europe The TRANS-South Study", - "phase": "Phase 3", - "drugs": "['Trafermin 0.01% spray']", - "drugs_list": [ - "Trafermin 0.01% spray" - ], - "diseases": "['Diabetic Foot Ulcer of Neuropathic Origin']", - "diseases_list": [ - "Diabetic Foot Ulcer of Neuropathic Origin" - ], - "enrollment": "201.0", - "inclusion_criteria": "Selection Criteria \n\n Patients who fulfill all of the following criteria (and none of the ", - "exclusion_criteria": " described below) are eligible to enter the placebo run-in phase of the study: \n\n Provide written informed consent to participate. \n\n Male or female patients age 18 years or older. \n\n Type 1 or 2 diabetes. \n\n A single full-thickness DFU that has been present for at least 2 weeks. \n\n DFU wound surface area below or equal 34 cm2 on the target foot. \n\n No exposure of bone in the target DFU. \n\n Neuropathy confirmed by loss of protective sensation to monofilament test (Semmes-Weinstein 5.07 monofilament). \n\n No predominant ischemia requiring further exploration or treatment, and confirmed by either: \n\n ABPI on the target leg ( >0.9;below or equal 1.3) or if ABPI is >1.3 or is not assessable,TBPI on target foot above or equal 0.7, OR \n\n ABPI on target leg (above or equal 0.7;below or equal 0.9) or if ABPI is >1.3 or is not assessable, TBPI on target foot <0.7, AND a toe blood pressure >40 mmHg \n\n inclusion criteria \n\n Patients who fulfill all of the following criteria are eligible for randomization: \n\n All of the selection criteria and none of the ", - "brief_summary": "Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan). Trafermin 0.01% cutaneous spray product kit consisting of a glass bottle containing lyophilized trafermin, a glass bottle with solvent for solution and a spray part to fit the glass bottle after reconstitution of the final product.~The investigators conduct a multinational, randomized, double-blind, placebo controlled, parallel-group, multicentre study consisting of a placebo run-in phase (2w), a treatment phase (max. 12w) and a follow-up phase (3mo+6mo). The primary objective of the study is to demonstrate a superior wound closure rate of diabetic foot ulcers (DFUs) of neuropathic origin after 12 weeks topical daily application of trafermin 0.01% spray compared with placebo, in addition to best local care (off-loading, dressings). Approximately 210 patients will be randomized and it is planned that this study will be conducted at approximately 30 investigational sites in an estimated 4 countries in Europe (Czech Republic,France,Hungary,Italy,).", - "NCTID": "NCT01217463" - }, - { - "brief_title": "Identification of Risk Factors of Prolonged Wound Healing Following Primary Arthroplasty", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Evaluate Surgical, Medical and Pharmacological Factors Influence on Wound Healing Following Primary Arthroplasty Surgery']", - "diseases_list": [ - "Evaluate Surgical", - "Medical and Pharmacological Factors Influence on Wound Healing Following Primary Arthroplasty Surgery" - ], - "enrollment": "1500.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients receiving primary hip or knee arthroplasty at Hvidovre Hospital from january 2012 to january 2014. \n\n ", - "exclusion_criteria": ": \n\n Not willing to participate. \n\n Drop out at 3 week follow up.", - "brief_summary": "Prolonged wound drainage following total joint replacement surgery has been shown to be a predictor of postoperative infection. Several factors have been associated with delayed wound healing and increased risk of infection. Namely hypertension, obesity, diabetes, smoking and autoimmune disease have been shown to have a detrimental effect on wound healing. The purpose of this study is to verify those findings and determine additional pharmacological, surgical and patient related factors that may result in prolonged wound drainage, prolonged hospital stay and increased risk of infection", - "NCTID": "NCT01477047" - }, - { - "brief_title": "Assessment of Efficacy & Safety for a New Wound Dressing Urgo 310 3166 in the Local Treatment of VLU or Mixed Leg Ulcers", - "phase": "", - "drugs": "['Urgo 3103166', 'Aquacel Extra']", - "drugs_list": [ - "Urgo 3103166", - "Aquacel Extra" - ], - "diseases": "['Leg Ulcers']", - "diseases_list": [ - "Leg Ulcers" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Patient over 18 years old who has provided his/her written informed consent, \n\n Patient who can be monitored by the same investigation team throughout the whole duration of the study, \n\n Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing, \n\n Leg ulcer with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3, \n\n Ulcer area > or equal to 5cm2, \n\n Ulcer duration > or equal to 6 months, \n\n Ulcer presenting a the surface wound bed covered with 50% or more by sloughy tissue, \n\n Moderately or heavily exudative ulcers. \n\n ", - "exclusion_criteria": ": \n\n Clinical infection on the wound bed.", - "brief_summary": "Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local treatment of venous or mixed leg ulcers: a European, randomised clinical trial.", - "NCTID": "NCT02583958" - }, - { - "brief_title": "Predictive of Biomarkers of Healing in Chronic Venous Ulceration of the Lower Limb", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Varicose Ulcer']", - "diseases_list": [ - "Varicose Ulcer" - ], - "enrollment": "28.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female over the age of 18 years \n\n Chronic venous ulceration - Defined as wound of greater than four weeks in duration between the foot and the ankle with an Ankle Brachial Pressure Index greater than 0.85. \n\n Ulceration present for at least four weeks. \n\n Colour venous duplex evidence of chronic venous insufficiency showing either reflux or obstruction. \n\n ", - "exclusion_criteria": ": \n\n Acute infection in the studied lower limb within the last four weeks \n\n History of malignancy in the lower limb to be studied \n\n History of connective tissue disease \n\n Patients on medications that can cause immunosuppression - Corticosteroids, chemotherapy or radiotherapy for cancer and recombinant immunological medications.", - "brief_summary": "Chronic venous ulceration of the lower limb poses a significant problem to patients and healthcare providers alike. 1% of the population of Western countries have either an open or healed chronic venous ulcer.~However, the pathophysiological abnormalities are not entirely clear in how raised venous pressure translates into the changes seen in the skin culminating in an open ulcer. The standard treatment of this condition in the United Kingdom is to undertaken compression bandaging of the lower limb.~In order to further their knowledge of venous ulceration, the investigators seek to determine the biological profile of venous ulcers over a maximum of twenty-eight weeks and by dividing the groups into healing and non-healing wounds, the investigators may be able to demonstrate a difference in the biological profile.~This work may provide insights into predicting who will respond to treatment and targets for treatment in the future.", - "NCTID": "NCT01998932" - }, - { - "brief_title": "Prevention of Bacteremia Induced by Debridement of Pressure Ulcer", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pressure Ulcers', 'Bacteremia']", - "diseases_list": [ - "Pressure Ulcers", - "Bacteremia" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient in the complex nursing department \n\n With contaminated pressure ulcers \n\n Going to have a debridement procedure \n\n ", - "exclusion_criteria": ": \n\n Penicillin sensitivity \n\n Bacteremia that does not react to the antibiotic treatment", - "brief_summary": "The purpose of this study is to analyse bacteremia induced by debridement of pressure ulcers in patients in the complex nursing department.", - "NCTID": "NCT00269100" - }, - { - "brief_title": "Clinical Trial to Evaluate the Efficacy, Tolerance and Acceptability of URGO Dressing vs a Hydrofibre in the Local Management of Venous or Predominantly Venous Mixed Leg Ulcers.", - "phase": "Phase 4", - "drugs": "['Dressing', 'Dressing']", - "drugs_list": [ - "Dressing", - "Dressing" - ], - "diseases": "['Varicose Ulcer']", - "diseases_list": [ - "Varicose Ulcer" - ], - "enrollment": "159.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient over 18 years old who has provided his/her written informed consent \n\n Patient who can be monitored by the same investigation team throughout the duration of the study \n\n Patient who agrees to wear effective venous compression every day, associated with the trial dressing \n\n Leg ulcer with a distal Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3 \n\n Ulcer with a minimum area of 3 cm2 and a maximum area of 30 cm2 \n\n Ulcer duration between 3 and 36 months \n\n Ulcer where the surface area is 70% or more covered by fibrinous tissue \n\n Ulcer at least 3 cm away from any other lesion \n\n Ulcer moderately or strongly exudative justifying the use of an absorbent dressing \n\n ", - "exclusion_criteria": ": \n\n Female patient of child-bearing potential who has no effective means of contraception \n\n Patient who is pregnant or breastfeeding \n\n Patient taking part in another therapeutic trial \n\n Patient with hypersensitivity to one of the components of the trial dressing or a known allergy to carboxymethylcellulose (hydrocolloid) \n\n Patient with a serious general pathological condition who, it may be feared, might discontinue participation in the trial before the six weeks of treatment \n\n Patient with an evolving neoplastic condition, treated by radiotherapy, chemotherapy or hormone therapy \n\n Patient with a systemic infection not controlled by suitable antibiotic treatment \n\n Patient who, during the 3 months before inclusion, presented a deep vein thrombosis \n\n Ulcer where its surface is totally or partially covered by black necrotic plaque \n\n Ulcer which is clinically infected \n\n Ulcer requiring surgical treatment or for which surgery is programmed during the six weeks following inclusion \n\n Malignant ulcer", - "brief_summary": "The main objective of this trial is to demonstrate that a local care strategy using URGO 310 3082 dressing is not inferior to a reference therapeutic strategy using a hydrofibre dressing in the management of venous ulcers. This non-inferiority hypothesis will be judged on the planimetric relative regression of the wound surface area after six weeks of treatment.", - "NCTID": "NCT01449422" - }, - { - "brief_title": "Effectiveness of Using an Oil Bath Additive", - "phase": "", - "drugs": "['Balneum oil bath']", - "drugs_list": [ - "Balneum oil bath" - ], - "diseases": "['Xerosis Cutis']", - "diseases_list": [ - "Xerosis Cutis" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Signed informed consent, or children whose parent(s) or guardian(s) have given their written informed consent for their child's participation in the study \n\n Child specific written informed consent, if over 7 years of age \n\n Subjects with a general good and stable health condition \n\n Subjects with clinically stable medical conditions \n\n Accept to abstain from sunbathing and solarium during the study \n\n Overall Dry Skin score (ODS) of 1 to 2 at arms and lower legs \n\n TEWL > 12 g/m2/h on the left mid volar forearm \n\n ", - "exclusion_criteria": ": \n\n Any dermatological condition or skin affection which may interfere with the study assessments, e.g. scars \n\n Suffering from porphyria \n\n Suffering from severe photodermatoses according to the judgment of the investigator \n\n Clinically significant, possibly unstable medical conditions such as metastatic tumor \n\n Currently having other malignant or benign tumors of the skin in the investigational area \n\n Any other acute or chronic pathology that may interfere with the study conduct in the investigator's opinion \n\n Known allergy or intolerance to any ingredients of the study product, e.g. propylene glycol \n\n Use of (medical) oil-containing bath additives or other oil-containing cleansers \n\n Current topical or systemic treatment affecting the skin, e.g. diuretics \n\n Treatment of dry and/or inflammatory skin conditions with topical corticosteroids during the 4 weeks before inclusion \n\n Systemic immunosuppressive or immunomodulatory therapy \n\n Topical retinoids applied during the 6 weeks before inclusion \n\n Topical application of immunosuppressive treatment during the 6 weeks before inclusion \n\n Therapeutic UV-Radiation during the 6 weeks before inclusion \n\n Increased UV-exposure during the 6 weeks before inclusion", - "brief_summary": "Epidermis that lacks moisture and/or sebum presents as dry skin, which is often characterized by a pattern of fine lines, scaling and itching. In dry skin, the barrier function may be compromised. Skin care practices to decrease the risk of development of dry skin and/or to improve dry skin condition have barely been investigated. Bathing with bath oils has been shown to increase skin hydration, thus helping to stabilize skin barrier function. Therefore, the aim of this study is to investigate the effect of bathing every other day on the skin barrier. Functional parameters, such as TEWL, stratum corneum hydration (SCH) and skin-pH (pH) were measured to characterize skin barrier function.", - "NCTID": "NCT02557698" - }, - { - "brief_title": "A Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids", - "phase": "", - "drugs": "['Suture', 'Clozex']", - "drugs_list": [ - "Suture", - "Clozex" - ], - "diseases": "['Keloid']", - "diseases_list": [ - "Keloid" - ], - "enrollment": "3.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or females, in good health, and at least 12 years of age. \n\n Individuals with 2 or more keloids on the trunk, arm, leg, and neck between 0.5 and 2 cm in length. \n\n Individuals who are willing and able to participate in the requirements of the study, including signing the informed consent. \n\n In the opinion of the investigator, the 2 keloids can be excised in a similar manner and closed properly with the two techniques and will benefit from the procedure. \n\n In the opinion of the investigator, the keloid could benefit from surgical procedure. \n\n ", - "exclusion_criteria": ": \n\n Individuals with keloids that do not fit into the criteria. \n\n Individuals who are planning pregnancy, pregnant, or breast feeding. \n\n Individuals with a history of medical or dermatologic conditions which, in the opinion of the investigator, would put the subject at heightened risk or would limit complicate the study evaluations required by the protocol. \n\n Individuals who present with excessive body hair in the designed keloid area. \n\n Individuals with uncontrolled diabetes. \n\n Individuals with autoimmune disorders (HIV/AIDs, SLE). \n\n Subjects who have received keloid treatment within one month of the first day of the study. \n\n Individuals who plan to receive keloid treatment(s) during the study. \n\n Individuals who are currently taking prescription or over the counter medication or interventions on a regular basis that as part of their mechanism of action, have the potential to mask an inflammatory reaction. Examples of such medications include, but are not limited to, corticosteroids, non-steroid anti-inflammatory drugs (NSAIDs), antihistamines, aspirin (81mg or less daily dosage permissible), or other medications that in the opinion of the investigator or designee may expose the subject to heightened risk or complicate the study assessments.", - "brief_summary": "This investigator initiated study, single-blinded, parallel, randomized study will be conducted in subjects with 2 or more keloids similar in size and duration on a similar area of the body. The response of the closure techniques will be evaluated by clinical and instrumental assessments. Each qualified subject will be assessed and the keloids will be randomly assigned to the Clozex or suture closure. One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with Clozex. A second keloid will be surgically excised and the surgical wound generated will be randomized to be closed with sutures. The inflammation index and the keloid recurrence rate at each surgical wound closure site will be compared.", - "NCTID": "NCT00519493" - }, - { - "brief_title": "Clinical Trial to Evaluate Ultrasonic Surgical Device in Chronic Pressure Ulcer", - "phase": "", - "drugs": "['ULSD-12D', 'SONOCA-180']", - "drugs_list": [ - "ULSD-12D", - "SONOCA-180" - ], - "diseases": "['Pressure Ulcer', 'Wound', 'Necrosis']", - "diseases_list": [ - "Pressure Ulcer", - "Wound", - "Necrosis" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n over 20 years of age \n\n subject who has untreated wounds \n\n subject who has wound size over 3cm x 3cm \n\n subject who has wound over stage 2 \n\n ", - "exclusion_criteria": ": \n\n cellulitis", - "brief_summary": "Study objective The purpose of this trial is to evaluate the efficacy and safety of the investigational device, ULSD-12D, as Compared to the comparator, SONOCA-180, in chronic wound.", - "NCTID": "NCT02007824" - }, - { - "brief_title": "Subcuticular Suture Versus Staples for Closure of the Skin After Caesarean Section.", - "phase": "", - "drugs": "['Staples left, subcuticular suture right', 'Subcuticular suture left side and staples right']", - "drugs_list": [ - "Staples left", - "subcuticular suture right", - "Subcuticular suture left side and staples right" - ], - "diseases": "['Cesarean Section', 'Cicatrix']", - "diseases_list": [ - "Cesarean Section", - "Cicatrix" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Woman having elective or level III caesarean section. Level III caesarean section is defined as being ordered more than 30 minutes before surgery is started. \n\n Woman who speak and understand Danish \n\n Woman who can give informed consent. \n\n ", - "exclusion_criteria": ": \n\n Level I or II caesarean section (ordered less than 30 min. before surgery is started). \n\n Diabetics (this does not include gestational diabetes). \n\n Infection \n\n Regular treatment with immunosuppressives \n\n Alcohol or drug abuse \n\n Age under 18 \n\n Chronic pain disease eg fibromyalgia, rheumatoid arthritis \n\n BMI over 35 \n\n Previous abdominal surgery through lower transverse abdominal incision (only applicable to woman having caesarean section for the first time).", - "brief_summary": "The Purpose of this study is to compare two methods for closure of the skin after caesarean section on the same patient; staples and subcuticular sutures. The study is performed on two separate groups of patients: 1. Woman having cesarean section for the first time and have not previously had abdominal surgery through a lower abdominal transverse incision. 2. Woman, who have previously had a caesarean section done. The following parameters are registered:~An objective evaluation of the two ends of the scar 6 months postoperatively.~A patient evaluation of the two ends of the scar 6 months postoperatively.~The difference in pain in the two ends of the scar 1 day postoperatively (blinded).~The difference in pain in the two ends of the scar 7 days, 3 and 6 months postoperatively.~The rate of infection.", - "NCTID": "NCT01217567" - }, - { - "brief_title": "Timing of Surgical Intervention in Buruli Ulcer Patients Treated With Antibiotics", - "phase": "", - "drugs": "['surgical intervention on Buruli ulcer']", - "drugs_list": [ - "surgical intervention on Buruli ulcer" - ], - "diseases": "['Mycobacterium Ulcerans Disease', 'Buruli Ulcer']", - "diseases_list": [ - "Mycobacterium Ulcerans Disease", - "Buruli Ulcer" - ], - "enrollment": "119.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with a clinical picture of Buruli ulcer disease in the districts covered by the Buruli ulcer centers in Lalo and Allada, Benin, will be included at start of antibiotic treatment. \n\n All stages of the disease will be included. Only patients with confirmed disease by direct microscopy following acid-fast staining or PCR will be included. \n\n ", - "exclusion_criteria": ": \n\n Patients not on the standard treatment of eight weeks of rifampicin and streptomycin for any reason, will be excluded from this study. \n\n Treatment with macrolide or quinolone antibiotics, or antituberculous medication, or immune-modulatory drugs including corticosteroids within the previous one month. \n\n Patients not compliant with the antibiotic therapy will be excluded as well. Non-compliance is defined as the use of < 70 % of the prescribed antibiotics. \n\n Patients with a contraindication for general anaesthesia are not able to participate. \n\n Pregnancy. \n\n Osteomyelitis. \n\n Lesion close to the eye, with preferred standard treatment to wait for effect antibiotic treatment on extent surgery. \n\n The BUFLS (Buruli ulcer functional limitation score) cannot be applied to children below three years and therefore will not participate. \n\n Patients reporting to refuse surgery at any point in the intended treatment, cannot be included. \n\n Any situation or condition which may compromise ability to comply with the trial procedures. \n\n Patients known to be HIV positive. \n\n Lack of willingness to give informed consent (and/or assent by parent/legal representative).", - "brief_summary": "SUMMARY~Rationale: Buruli ulcer, caused by Mycobacterium ulcerans, is an ulcerative disease endemic in West Africa. It often leads to functional limitations. Treatment was by extensive surgery, until in 2005 gradually antibiotic treatment for eight weeks with rifampicin and streptomycin was added. Observation of Buruli ulcer lesions of limited size during antibiotic treatment showed that during treatment there is a paradoxical increase of the lesion, with a decrease of the lesion after week 14. Current WHO protocols advise to decide whether surgery is needed four weeks after the start of antibiotics. This might be too early in the healing process. The investigators hypothesize that delay in surgery is safe, and that it results in a reduction of the number of surgical interventions.~Objectives:~Primary Objective of this study is to compare the need for surgical treatment in standard timing of surgery at the end of eight weeks antimicrobial treatment with a policy to postpone surgical treatment until week 14.~Secondary Objectives are to study whether postponing surgery leads to less extensive surgery and a change in frequency of functional limitations;~Study design:~Patients will be randomized for surgery at week 8 after start of antibiotic treatment and week 14 after start of treatment. Reasons for treating doctors to decide to intervene with surgery will be according to current clinical practice and will be clearly defined in this protocol. Standard care of eight weeks of rifampicin and streptomycin will be given. All patients will be followed and lesional size using acetate sheet recordings will be used during follow-up.~Study population: Patients with a clinical picture of Buruli ulcer disease confirmed by diagnostic tests in the districts covered by the Buruli ulcer centers in Lalo and Allada, Benin. Patients who are pregnant, have a contraindication for general anaesthesia and children below three years old will be excluded. 130 Patients in each treatment arm will be included to detect a difference in percentage of patients needing surgery of 20 percent.~Main study parameters/endpoints: Primary outcome measure is the number of patients healed without surgery. Secondary outcome measures are the extent of surgery by measurement of lesional size, functional limitations after the end of treatment and one year after the start of treatment and the duration of admission.", - "NCTID": "NCT01432925" - }, - { - "brief_title": "Hyperbaric Oxygen for Traumatic and Non-traumatic Brain Injury", - "phase": "Phase 2", - "drugs": "['Hyperbaric Oxygen', 'Minimal pressure air']", - "drugs_list": [ - "Hyperbaric Oxygen", - "Minimal pressure air" - ], - "diseases": "['Brain Injury, Chronic']", - "diseases_list": [ - "Brain Injury", - "Chronic" - ], - "enrollment": "49.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults, age 18-70 years, both men and women \n\n Able to speak and read English as primary language \n\n Able and willing to provide written informed consent for study participation. \n\n Able and willing to complete outcome assessments and provide blood and urine samples as required by the study protocol. \n\n Able to tolerate the chamber environment and hood placement and to equalize middle ear pressure. \n\n Past history of at least one brain injury with persistent symptoms that meets all of the following criteria: \n\n Brain injury of non-stroke etiology that occurred at least 6 months but no more than 10 years prior to enrollment. \n\n At least 3 of the following persistent symptoms from the injury: headaches, dizziness or balance problems, blurred vision, tiredness/fatigue or sleep problems, seizures, remembering things or solving problems, managing stress or emotional upsets, controlling temper/irritability, depression, anxiety, post-traumatic stress, or ringing in the ears. \n\n Normal thyroid stimulating hormone and hematocrit value greater than 35% within the previous 6 months. \n\n ", - "exclusion_criteria": ": \n\n Contraindications to hyperbaric oxygen \n\n Insulin-dependent diabetes mellitus, or diabetes mellitus that is not reasonably controlled. \n\n Uncontrolled seizure disorder (participants must be on therapy and seizure-free for at least 6 months). \n\n Claustrophobia precluding chamber or hood tolerance. \n\n Implanted devices not cleared for hyperbaric pressurization. \n\n Pregnancy or plans to become pregnant during the study participation period. Women of childbearing potential will be asked to use an acceptable form of birth control during study participation. \n\n Lung disease, such as emphysema, chronic bronchitis, asthma that is not well-controlled, or bullous lung disease that raises the risk for pulmonary barotrauma due to air trapping. \n\n Active malignancy, previous malignancy (except basal cell carcinoma) in the last 5 years, or any prior treatment with bleomycin (Blenoxane). Prior treatment with doxorubicin (Adriamycin) is acceptable as long follow-up echocardiography is normal. \n\n Chronic disease such as heart or renal failure would raise the participant's risk of adverse events during hyperbaric oxygen. \n\n Confounds to the outcome assessments \n\n Inability to speak English as their primary language (English fluency required because many of the outcomes are only in available in English) \n\n Instability with walking requiring more than a cane for assistance \n\n Alcohol abuse, by self-report, within the last year. \n\n Lifetime history of illicit drug use, by self-report, except remote (greater than one year), non-habitual use of marijuana. \n\n Failed urine drug screen during study participation. \n\n Continued participation during the intervention period in sports activities where head injury is likely, such as contact football, boxing, mixed martial arts, etc. \n\n Blind or deaf. \n\n Major psychiatric disorder or degenerative mental disease (such as multiple sclerosis). \n\n Prior therapeutic radiation to the central nervous system. \n\n Personal history of any condition that pre-dates their brain injury that resulted in diminished capacity (such as chromosomal disorders) or that, in the opinion of the investigators, affects cognition to such a degree that the outcome assessments are invalidated (such as learning disability or attention deficit hyperactivity disorder requiring pharmaceutical therapy as an adult). \n\n Any brain injury from stroke (ischemic or hemorrhagic) \n\n Known untreated chronic or acute medical conditions, such as hypothyroidism, Cushing's disease, untreated hypertension, etc., that would confound the outcome assessments or inhibit compliance with the study protocol. If treated, these disorders would not be excluded. \n\n Concomitant enrollment in any other drug/device clinical trial. \n\n Prior hyperbaric oxygen for any reason within the last year.", - "brief_summary": "The purpose of this study is to examine whether 40 hyperbaric oxygen sessions has effect on long-term symptoms after brain injury. This study will enroll 90 individuals with persistent problems 6 months to 10 years after a brain injury. These individuals will be randomized to receive either oxygen or air in a pressurized hyperbaric chamber. Participants will receive 40 daily hyperbaric chamber sessions.~Participants will have a series of tests and questionnaires before they begin their chamber sessions, after they complete 40 sessions, and 6 months after they joined the study. These tests include computer-based and pencil-and-paper questionnaires and thinking tests, brain imaging, a neurological examination, and an eye exam. Participants will also be asked to provide blood for future research.~After the 6-month tests are complete, all participants will receive 40 hyperbaric oxygen sessions, then undergo the same tests at 9 months and 12 months.", - "NCTID": "NCT01986205" - }, - { - "brief_title": "Evaluation of the Kinetic Properties of an Autologous Microbiome Transplant in Adult Atopic Dermatitis Patients", - "phase": "Phase 2", - "drugs": "[\"Moisturizer with each subject's own antimicrobial bacteria\"]", - "drugs_list": [ - "Moisturizer with each subject's own antimicrobial bacteria" - ], - "diseases": "['Atopic Dermatitis', 'Eczema']", - "diseases_list": [ - "Atopic Dermatitis", - "Eczema" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female subjects who are not pregnant or lactating \n\n 18-80 years of age \n\n Diagnosis of atopic dermatitis for at least 6 months using the Hanifin and Rajka Diagnostic Criteria for atopic dermatitis \n\n Presence of lesional atopic dermatitis skin in both antecubital fossae \n\n Positive S. aureus colonization based on results of a skin culture taken from one of their AD-affected antecubital fossae during the screening visit \n\n ", - "exclusion_criteria": ": \n\n Use of any topical AD treatments (including topical steroids, topical calcineurin inhibitors) to either arm within one week of either screening visit \n\n Use of any oral/systemic AD therapies (antihistamines, steroids) within 28 days of either screening visit \n\n Severe AD that would worsen significantly from holding a participant's usual topical/oral AD medications for the time periods required in the inclusion/", - "brief_summary": "Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of S. aureus skin infections. In addition, research in the investigator's lab has shown that these patients have fewer protective Staphylococcal species such as Staphylococcus epidermidis (S. epidermidis) that are known to produce antimicrobial peptides that play a role in protecting the skin from invading pathogens. In this study, the study team will attempt to decrease S. aureus colonization and increase colonization by protective Staph species in AD patients by first culturing the bacteria on subjects' lesional AD skin. The study team will selectively grow the subject's protective Staph colonies and place them into a moisturizer. The first part of the study will determine the half-life of the bacteria-containing moisturizer. The bacteria-containing moisturizer will be applied to a subject's arm, and the subject will return at four different time points over the next three days for skin swabs of the arm that will be used to determine the amount and type of bacteria on the arm at those time points. In the second part of the study, the subject will apply moisturizer containing his own antimicrobial bacteria to one of his arms for a total of 6 times at a frequency determined by the half-life, which will be computed at the end of the first part of this experiment. The subject will return prior to the 7th application time point for skin swabs of the arm to ensure that there are still viable bacteria from the moisturizer present on the arm. In the third part of the study, each subject will receive both moisturizer as well as moisturizer plus his own antimicrobial bacteria. The subject will apply the moisturizer to one arm and the moisturizer plus bacteria to the other arm daily for a total of 15 days. Subjects will return to the clinic every 5 days for skin swabs and clinical evaluations. If the moisturizer containing bacteria is able to decrease the S. aureus colonization on subject's arms, the study team hypothesizes that subjects will have improvement of their AD symptoms.", - "NCTID": "NCT02144142" - }, - { - "brief_title": "Pressure Ulcer Prevention in Intensive Care Unit (ICU)", - "phase": "", - "drugs": "['Mepilex Border Dressing']", - "drugs_list": [ - "Mepilex Border Dressing" - ], - "diseases": "['Pressure Ulcers']", - "diseases_list": [ - "Pressure Ulcers" - ], - "enrollment": "440.0", - "inclusion_criteria": "inclusion criteria: \n\n ED and ICU admission for critical illness and/or major trauma Over 18 years old \n\n ", - "exclusion_criteria": ": \n\n Less than 18 years old Suspected or actual spinal injury Pre-existing sacral or heel pressure ulcer Trauma to sacral and/or heel area", - "brief_summary": "The study is designed as a randomised controlled trial of trauma patients admitted to the Royal Melbourne Hospital (RMH) Emergency Department (ED) and subsequently transferred to the Intensive Care Unit (ICU). Patients meeting the study inclusion criteria will be randomly allocated to either the control group that will receive usual pressure ulcer prevention strategies or the trial group that will receive usual care plus have a Mepilex Border Sacrum dressing applied to their sacrum and Mepilex Boarder Heel dressing applied to each heel in the ED.~Hypothesis:Patients treated with Mepilex Border dressings will have a lower incidence rate of sacral and heel pressure ulcer development than patients receiving standard care.", - "NCTID": "NCT01356459" - }, - { - "brief_title": "Extended-Release Oxybutynin for the Treatment of Neurogenic Detrusor Overactivity", - "phase": "Phase 4", - "drugs": "['Oxybutinin Extended-Release']", - "drugs_list": [ - "Oxybutinin Extended-Release" - ], - "diseases": "['Detrusor Function, Overactive']", - "diseases_list": [ - "Detrusor Function", - "Overactive" - ], - "enrollment": "17.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of overactive bladder as a result of neurogenic condition, for example following spinal cord injury, multiple sclerosis (slowly worsening disorder of the central nervous system that causes symptoms such as weakness, incoordination, numbness, problems talking and problems seeing), Parkinson's disease (a progressive disorder of the central nervous system, seen usually in older persons, in which there is slow movement [due to muscle weakness], trembling and sweating), or cerebrovascular accidents (CVAs - stroke-sudden loss of blood supply to brain) \n\n Women must not be pregnant and be of either non-childbearing potential or is using adequate means of birth control \n\n Overactive bladder symptoms and/or has urge incontinence episodes \n\n Must have normal results on urine culture tests and on urinalysis \n\n ECOG (Eastern Cooperative Oncology Group) performance status score of less than or equal to 3 \n\n ", - "exclusion_criteria": ": \n\n Participants with 1 or more treatable or conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency \n\n Any medical or unstable condition that precludes their participation in the study or may confound the outcome of the study (participants with or at risk for urinary retention, gastric retention or uncontrolled narrow angle; heart failure or kidney failure; diabetes mellitus; abnormal muscle weakness [myasthenia gravis]; paralysis or inactivity in the intestines that prevents material moving through the gut [intestinal atony or paralytic ileus]; severe inflammation of the bowel [ulcerative colitis] sudden expansion of the large intestine seen in advanced ulcerative colitis or Crohn's disease [toxic megacolon]; history of major lower urinary tract surgery [transurethral resection will be excluded]) \n\n Hypersensitivity to the investigational drug or any of its ingredients (eg, lactose) \n\n Pregnant or breast feeding female \n\n Significant bacteriuria (presence of bacteria in the urine) or pyuria (presence of white blood cells) in the urine", - "brief_summary": "The purpose of this study is to evaluate the effects and tolerability (how well a participant can stand a particular medicine or treatment) of flexible dose Oxybutynin Extended-Release (OXY-ER, Lyrinel) including safety and quality of life assessment in participants with neurogenic detrusor overactivity (NDO - the nerves mediating the detrusor muscle do not work properly leading to frequent feeling of need to urinate during the day, night, or both).", - "NCTID": "NCT01796548" - }, - { - "brief_title": "Antibiotics for the Treatment of Ulcerative Colitis", - "phase": "", - "drugs": "['Cefuroxime', 'Ciprofloxacin', 'Clarithromycin', 'Cotrimoxazole', 'Coamoxiclav', 'metronidazole', 'neomycin', 'rifaximin', 'Vancomycin', 'Doxycycline']", - "drugs_list": [ - "Cefuroxime", - "Ciprofloxacin", - "Clarithromycin", - "Cotrimoxazole", - "Coamoxiclav", - "metronidazole", - "neomycin", - "rifaximin", - "Vancomycin", - "Doxycycline" - ], - "diseases": "['Colitis, Ulcerative']", - "diseases_list": [ - "Colitis", - "Ulcerative" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Active ulcerative colitis, CAI greater than or equal to 4 \n\n ", - "exclusion_criteria": ": \n\n Antibiotics in the last 3 months \n\n Probiotics \n\n Alteration to medications in last 3 months", - "brief_summary": "Ulcerative colitis (UC) is an acute and chronic inflammatory bowel disease, whose cause is unknown. However, it is widely accepted that bacteria living in the large bowel are essential for the development of the disease. Intuitively, therefore, a logical approach to treatment would be to use antibiotics. However, antimicrobial chemotherapy has been unsuccessful in managing acute colitis, and has had only limited benefit in long-term treatment. The failure of antibiotics in UC arises from the fact that no-one has tried to identify which bacteria are involved in causing disease, and equally importantly, nobody has targeted appropriate antibiotics to knock out the specific bacteria in question, in a systematic way. Despite this, increasing evidence implicates bacteria living on the lining of the bowel being involved in UC. Our aim, therefore is to identify bacteria colonizing the mucosal surface in the lower large intestine and to determine the antibiotic sensitivities of those the investigators believe to be particularly involved in the disease, such as enterococcit, peptostreptococci and enterobacteria. Because the investigators have already studied resistance to antimicrobial in many mucosal isolate, the investigators plan ot focus on using a combination of two antibiotics in this work. A controlled trial will test the benefit of using these antibiotics over a period of one month and then the patients will be followed up over a six month period. The investigators will be looking for significant long-term improvements, and a reduction in drug use following antibiotic therapy.", - "NCTID": "NCT00355602" - } - ], - "1": [ - { - "brief_title": "Multi-arm Intervention Diabetes Adherence Study", - "phase": "Phase 3", - "drugs": "['Adherence information', 'Adherence information plus motivational interviewing']", - "drugs_list": [ - "Adherence information", - "Adherence information plus motivational interviewing" - ], - "diseases": "['Diabetes']", - "diseases_list": [ - "Diabetes" - ], - "enrollment": "1692.0", - "inclusion_criteria": "inclusion criteria: \n\n At least 2 dispensings for oral medications used to treat diabetes and dyslipidemia in the last 18 month. \n\n At least one laboratory result for both glycated hemoglobin and LDL-cholesterol in the last 6 months. \n\n Average HbA1c \u2265 7% OR an average LDL \u2265 100 mg/d \n\n Continuous health plan enrollment currently and in the previous calendar year with no more than a 1 month lapse of coverage, and benefits that include both medical and pharmacy coverage. \n\n ", - "exclusion_criteria": ": \n\n Patients who have been institutionalized in a nursing home or in a long-term care facility for more than 3 months in the preceding 18 month period. \n\n Participation in a disease management program", - "brief_summary": "The purpose of this study is to compare the effectiveness of two different interventions to improve adherence to diabetes medications among patients with diabetes and poor metabolic control.", - "NCTID": "NCT00754741" - }, - { - "brief_title": "Evaluation of Levemir\u00ae for the Treatment of Type 1 and 2 Diabetes", - "phase": "", - "drugs": "['insulin detemir']", - "drugs_list": [ - "insulin detemir" - ], - "diseases": "['Diabetes', 'Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']", - "diseases_list": [ - "Diabetes", - "Diabetes Mellitus", - "Type 1", - "Diabetes Mellitus", - "Type 2" - ], - "enrollment": "3637.0", - "inclusion_criteria": "inclusion criteria: \n\n Type 1 diabetes \n\n Type 2 diabetes \n\n Candidates of use of a basal insulin as part of their diabetes regimen \n\n ", - "exclusion_criteria": ": \n\n Unwilling to adhere to therapy or follow up \n\n Pregnancy", - "brief_summary": "This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using Levemir\u00ae under normal clinical practice conditions.", - "NCTID": "NCT00655044" - }, - { - "brief_title": "Development of a Cellular Biomarker for the Diagnosis and Treatment of Diabetic Foot Ulcers", - "phase": "", - "drugs": "['Specimen Collection']", - "drugs_list": [ - "Specimen Collection" - ], - "diseases": "['Diabetic Foot Ulcer', 'Type 2 Diabetes']", - "diseases_list": [ - "Diabetic Foot Ulcer", - "Type 2 Diabetes" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female, age \u2265 18 \n\n Type 2 Diabetes \n\n A break in the skin on the foot \u2265 0.5cm2 and is Grade 1 or 2 as defined by the Wagner grading system \n\n Hemoglobin A1c \u2265 5.9% \n\n Ability to provide written informed consent \n\n ", - "exclusion_criteria": ": \n\n Any experimental drugs taken orally or topically within 4 weeks of study entry \n\n Malignant disease at/or in proximity to the DFU \n\n Target wound of malignant origin \n\n Failure to satisfy at least one inclusion criterion for one of the two study groups.", - "brief_summary": "This project aims to result in the identification of such markers, and the development of a feasible quantitative method of distinguishing between tissue that has the capacity to heal and tissue that does not, thus identifying a non-healing phenotype.", - "NCTID": "NCT02329366" - }, - { - "brief_title": "A Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)", - "phase": "Phase 2", - "drugs": "['Metformin', 'skin biopsy', 'diet and exercise', 'pioglitazone', 'rosiglitazone']", - "drugs_list": [ - "Metformin", - "skin biopsy", - "diet and exercise", - "pioglitazone", - "rosiglitazone" - ], - "diseases": "['Insulin Resistance', 'Diabetes Mellitus']", - "diseases_list": [ - "Insulin Resistance", - "Diabetes Mellitus" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Obese patients (wt > 95th percentile for age, for adults increased BMI > 27) greater than 5 years of age \n\n And/or presence of complications of insulin resistance such as acanthosis nigricans, dyslipidemia, elevated blood pressure, hyperandrogenism \n\n Siblings and parents of patients with insulin resistance. Siblings and parents will be included only in the case of documented insulin resistance in the index subject. Insulin resistance will be documented by OGTT and/or IVGTT. \n\n Family history of type II diabetes. \n\n ", - "exclusion_criteria": ": \n\n Critically ill patients, patients will congestive heart failure, renal or liver insufficiency \n\n Inability to give consent. \n\n History of poor compliance with physician's recommendations", - "brief_summary": "The goal of this study is to aggressively treat insulin resistance and its clinical manifestations when they first appear in childhood, and to prevent the subsequent progression towards impaired glucose tolerance and type-2 diabetes. In the process of this clinical trial, we will learn more about the early manifestations of insulin resistance, its treatment, and its relationship to obesity and type-2 diabetes through parallel in-vivo and in-vitro studies.", - "NCTID": "NCT00015626" - }, - { - "brief_title": "Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds", - "phase": "", - "drugs": "['SNaP\u00ae Wound Care System']", - "drugs_list": [ - "SNaP\u00ae Wound Care System" - ], - "diseases": "['Lower Extremity Diabetic Leg Wounds', 'Lower Extremity Venous Leg Wounds', 'Lower Extremity Mixed Aetiology Leg Wounds']", - "diseases_list": [ - "Lower Extremity Diabetic Leg Wounds", - "Lower Extremity Venous Leg Wounds", - "Lower Extremity Mixed Aetiology Leg Wounds" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient has diabetic foot ulceration, venous ulcer, or mixed aetiology ulcer with a surface area <100 cm2 and <10 cm in widest diameter on lower extremity, but larger than 1 cm2 (venous and mixed aetiology ulcers will be defined by clinical exam of treating physician. Diabetic foot ulcers will be defined by clinical exam of the treating physician and as lower extremity ulcers in patients with a diagnosis of diabetes, but without venous stasis disease). \n\n Wound present for >30 days. \n\n Patient has wound in location amenable to creation of airtight seal around wound using TNP dressings. \n\n Patient is able to comply with study protocol requirements. \n\n Patient is able to understand and provide written consent. \n\n ", - "exclusion_criteria": ": \n\n Patient has evidence of wound infection in the opinion of the physician. \n\n Patient has a thick eschar that persists after wound debridement. \n\n Patient has an HbA1C >12%. \n\n Patient has ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinaemia, necrobiosis lipoidica, panniculitis, lupus erythematosus, scleroderma, or calcinosis. \n\n Patient has untreated osteomyelitis. \n\n Patient has any other condition that, in the opinion of the investigator, makes the patient inappropriate to take part in this study. \n\n Patient is allergic to the wound care device or occlusive dressing. \n\n Patient has exposed blood vessels. \n\n Patient is pregnant or pregnancy is suspected. \n\n Patient is actively participating in other clinical trials that may interfere with their participation in this study.", - "brief_summary": "The purpose of this study is to evaluate a novel topical negative pressure (TNP) wound therapy device called the SNaP\u00ae (Smart Negative Pressure) Wound Care System for the treatment of lower extremity diabetic, venous and mixed aetiology leg wounds.", - "NCTID": "NCT01417208" - }, - { - "brief_title": "Testing MST to Improve Adherence Among Youth With Chronic Poor Metabolic Control", - "phase": "", - "drugs": "['Multisystemic Therapy']", - "drugs_list": [ - "Multisystemic Therapy" - ], - "diseases": "['Type 1 Diabetes']", - "diseases_list": [ - "Type 1 Diabetes" - ], - "enrollment": "127.0", - "inclusion_criteria": "inclusion criteria: \n\n a current hemoglobin A1c(HbA1c) of >8.0% \n\n an average HbA1c of >8.0% during the past year \n\n diagnosed with Type 1 diabetes for at least one year \n\n reside in the metro Detroit tri-county area \n\n ", - "exclusion_criteria": ": \n\n severe mental impairment/thought disorder \n\n non-English speaking patient/parent \n\n co-morbid major medical condition such as cystic fibrosis", - "brief_summary": "The protocol is a randomized clinical trial providing Multisystemic Therapy (MST), an intensive home-based family psychotherapy intervention, to a group of urban adolescents with poorly controlled Type 1 diabetes and their families.", - "NCTID": "NCT00519935" - }, - { - "brief_title": "Efficacy and Safety of Garamycin\u00ae Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection", - "phase": "Phase 4", - "drugs": "['Garamycin Sponge (Gentamicin-Collagen sponge)', 'Systemic Antibiotic']", - "drugs_list": [ - "Garamycin Sponge (Gentamicin-Collagen sponge)", - "Systemic Antibiotic" - ], - "diseases": "['Diabetic Foot Ulcer']", - "diseases_list": [ - "Diabetic Foot Ulcer" - ], - "enrollment": "88.0", - "inclusion_criteria": "inclusion criteria: \n\n Is aged \u2265 18. \n\n Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria. \n\n Has an open foot wound with visible inflammation, namely at least 1 skin ulcer located on or below the malleolus that presents with the following clinical manifestations of a moderate or severe infection based on the Infectious Disease Society of America (IDSA). \n\n Has received appropriate surgical intervention to remove all necrotic and infected bone if diagnosed with osteomyelitis \n\n Meets certain minimal laboratory criteria. \n\n ", - "exclusion_criteria": ": \n\n Has an ulcer infection which, based upon the patient's known history of hypersensitivity cannot be appropriately treated with at least one of the empiric systemic antibiotic regimens per protocol. \n\n Has received > 48 hours of potentially effective antibiotic therapy and the wounds are clinically improving. If a patient has received an antibiotic within 72 hours, but is not improving or deep-tissue culture results indicate that the infecting pathogen is not susceptible to that antibiotic, the patient may be enrolled. \n\n Requires or is likely to require treatment with any concomitant topical product or wound therapy during the study period.", - "brief_summary": "The purpose of this study is to determine whether Garamycin Sponge (Gentamicin-Collagen sponge) in combination with antibiotics is safe and effective in treating moderate and severe diabetic foot infections.", - "NCTID": "NCT01951768" - }, - { - "brief_title": "TACTICS (Targeting Adherence to Cholesterol-lowering Therapy to Improve Control Study)", - "phase": "", - "drugs": "['stage-matched intervention', 'framing effects intervention', 'attention placebo intervention']", - "drugs_list": [ - "stage-matched intervention", - "framing effects intervention", - "attention placebo intervention" - ], - "diseases": "['Hypercholesterolemia']", - "diseases_list": [ - "Hypercholesterolemia" - ], - "enrollment": "247.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults with diabetes \n\n LDL greater than or equal to 100 \n\n Cholesterol-lowering drug therapy for > 6 months \n\n A working telephone \n\n At least 2 primary care visits in the past 1.5 years \n\n ", - "exclusion_criteria": ": \n\n Poor short-term survival (< 1 year) \n\n Inability to understand English \n\n Recent major surgery (< 3 months) \n\n Patients temporarily in the area \n\n Inability to provide consent", - "brief_summary": "Background:~This is a randomized controlled trial (RCT) of two novel behavioral interventions to enhance treatment adherence and improve low-density lipoprotein cholesterol (LDL) in diabetes. Among adults with diabetes, high LDL greatly increases their risk for cardiovascular disease (CVD). Despite the proven efficacy of LDL control(<100 mg/dL) in preventing CVD, the control rate is low. Poor adherence to treatment(diet, exercise and medication) is the main reason for this poor control.~Aims: This study will test two telephone-delivered interventions, a Transtheoretical stage-matched intervention (SMI) and a Prospect theory-based framing effects intervention (FEI). The investigators hypothesize that both SMI and FEI will be more effective in improving LDL control than an attention placebo intervention (API) at 6 months. SMI and FEI will also be more effective in increasing adherence to medications, diet and exercise than API at 6 months.~Methods:~The investigators will recruit 246 adults with diabetes and high LDL despite being on medications. Key outcomes are adherence to diet, exercise and medication, and LDL control. The interventions will be standardized and fidelity of intervention maintained. Using a blinded RCT the investigators will test the effect of SMI and FEI compared to API on LDL control and adherence. All analyses will be intent to treat.~Significance:~This project will provide important information to improve diabetes-related behavior and lead to the implementation of novel interventions for lowering LDL in primary care settings among adults with diabetes. It may also provide the scientific rationale to use such approaches to control other risk factors in diabetes.", - "NCTID": "NCT01043354" - }, - { - "brief_title": "Study of the Efficacy of Sharp Debridement for the Management of Chronic Wounds", - "phase": "", - "drugs": "['debridement']", - "drugs_list": [ - "debridement" - ], - "diseases": "['Wounds']", - "diseases_list": [ - "Wounds" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject must have evidence of a full-thickness cutaneous wound of at least 30 days duration. \n\n Subject must be at least 18 years of age. \n\n Subject must have a minimum life expectancy of at least 1 year to be determined by the Investigator. \n\n The study ulcer must be from 1 cm2 to 20 cm2 in size. \n\n The study ulcer must have been present for at least 30 days at study Day -7. \n\n The subject's Glycosylated hemoglobin (HbA1C) must be equal to or less than 10.0% for subjects with diagnosed diabetes at study Day 0. \n\n The subject, legal guardian or authorized representative must have understood, signed and dated the IRB approved informed consent form. \n\n The subject must be available for evaluation on a weekly basis for the twelve (12) weeks of the study. Visits at Week 13 and Week 14 are required for initial wound healing, which is achieved in study Week 11 or 12. The Investigator will evaluate both groups at Week 16. Subjects must be available for evaluation at Week 16. \n\n The subject's TCpO2 must be equal to or greater than 25 mm of mercury in the periwound area and ABI greater than 0.7. \n\n ", - "exclusion_criteria": ": \n\n Subject whose ulcer has healed 30% or greater from the evaluation Study day -7 to the post-debridement Study Day 0 as determined by wound measurements using ARANZ Silhouette \n\n A history of alcohol or substance abuse, within the previous year, which could, or in the judgment of the Investigator, would interfere with study compliance or protocol requirements. \n\n Participation in clinical trials evaluating investigational pharmaceuticals, biologics or devices within 30 days of admission to the study. \n\n Subject with a history of receiving any of the following within the last 30 days: systemic corticosteroids exceeding a total daily dose of 20mg, immunosuppressive agents, radiation therapy or chemotherapy. Anticipated use of the above during the study period will also exclude a subject from entry into the study. Topical and inhaled corticosteroids are not prohibited. \n\n Subjects with medical comorbidities known to affect wound healing such as end stage renal disease, severe hepatic insufficiency, vasculitis, and HIV will be excluded from this study", - "brief_summary": "Standard care of care and up to twelve (12) weekly debridements. Subjects randomized into the weekly debridement group will receive up to twelve (12) debridement during the twelve (12) weeks of the study. There will be two (2) subject groups in the study. Subjects will be randomized into either the monthly debridement group or the weekly debridement group.", - "NCTID": "NCT00990522" - }, - { - "brief_title": "Shockwave Therapy of Chronic Diabetic Foot Ulcers", - "phase": "", - "drugs": "['Extracorporeal shockwave therapy']", - "drugs_list": [ - "Extracorporeal shockwave therapy" - ], - "diseases": "['Diabetic Foot Ulcer']", - "diseases_list": [ - "Diabetic Foot Ulcer" - ], - "enrollment": "23.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients receiving care and treatment in OUH Wound Clinic (Odense University Hospital, Denmark) with a diabetic foot ulcer. \n\n Wagner groups 1 and 2 (Wagner Ulcer Classification System) \n\n ", - "exclusion_criteria": ": \n\n Patients with an ulcer duration of less than 2 months \n\n Ulcer area less than 0,5 x 0,5 cm (or less than 0,25 cm2) \n\n Patients who have had vascular surgery performed within the past 2 months \n\n Patients who cannot give informed consent \n\n Patients who do not read or speak danish \n\n Wagner groups 3 and 4 (Wagner Ulcer Classification System)", - "brief_summary": "Introduction:~Foot ulcers are a feared complication among diabetic patients. The ulcers can cause pain, discomfort and reduced quality of life. The development of foot ulcers places the patients at a risk of amputation. In the Danish Health Care System a substantial effort is done to prevent and treat diabetic foot ulcers. A constant research of how to treat these wounds is ongoing. The goal is to optimize wound healing and prevent amputations.~Extracorporeal shockwave therapy (ESWT) involves the use of a device that generates low-energy shockwaves through a headpiece, which is placed on the skin of the patient. A small amount of energy will be deposited in the tissue when shockwaves are applied. This stimulates the cells to produce substances that generate new vessels. No side effects to ESWT have been shown.~Purpose:~The investigators want to test whether shockwave therapy can improve wound healing among diabetic patients with foot ulcers.~Hypothesis:~The investigators hypothesize that shockwave therapy accelerates ulcer healing, increases blood flow, reduces pain, and has no side effects.~Method:~Patients who are interested in participation will be included in the study and divided by randomization into two groups of equal size. The first group is treated with ESWT in combination with regular guideline treatment. The second group is set up as control group and will only receive regular guideline treatment. The participants are examined in different ways to evaluate whether ESWT helps the healing of foot ulcers. The investigators want to measure tissue oxygen pressure and foot sense of touch. The foot ulcers are inspected for infection at every consultation, and a swab sample will be collected at enrollment. The size of the ulcers are measured and photographed each time. The investigators will count how many foot ulcers that are completely healed during the test period and measure the sizes of the remaining foot ulcers. The patients are asked to evaluate pain related to the foot ulcer. Data concerning participants' co morbidities and use of analgesic drugs are obtained from the patient journal and by patient interview.~Significance:~ESWT should be considered a supplement to existing clinical guidelines in wound management if shown to effectively help healing of diabetic foot ulcers. Improved healing should reduce the heavy workload on care and treatment regarding to these wounds. Hopefully, the frequency of amputations among diabetic patients will decline by implementing new treatment options for the diabetic foot.", - "NCTID": "NCT02251418" - }, - { - "brief_title": "A Comparison of Insoles Used to Prevent Neuropathic Diabetic Foot Ulceration", - "phase": "Phase 2; Phase 3", - "drugs": "['Insole']", - "drugs_list": [ - "Insole" - ], - "diseases": "['Diabetes', 'Neuropathic Foot']", - "diseases_list": [ - "Diabetes", - "Neuropathic Foot" - ], - "enrollment": "119.0", - "inclusion_criteria": "inclusion criteria: \n\n diagnosed as having Type 1 or 2 diabetes mellitus, (recorded within the case notes and confirmed by participant), \n\n diagnosed with diabetic peripheral neuropathy \n\n palpable or biphasic pulses \n\n intact from lower limb vascular or neuropathic ulceration, scoring Grade 0 on the Wagner classification for foot ulcer \n\n able to walk a minimum of 10 metres unaided \n\n willing to comply with the requirements of the study. \n\n ", - "exclusion_criteria": ": \n\n presented with current or recently healed ulceration less than 6 months prior to study enrolment, \n\n severe fixed mid-foot or rearfoot deformity e.g. charcot joint, unsuitable for prefabricated insoles and non- bespoke footwear, \n\n history of major bone or joint surgery of the lower limb including major amputation \n\n unable to comprehend simple instructions and comply with the study protocols and procedures.", - "brief_summary": "Importance of the topic:~Lower extremity amputation is a costly complication of diabetes for both the NHS and the patient. Amputation may be avoided if the preceding foot ulceration can be prevented. One method of reducing the risk of ulceration in the neuropathic foot is through the provision of therapeutic insoles. The type of insole prescribed (prefabricated verses custom made) is currently based on anecdotal evidence. The idea held by many practitioners that the custom made insole is superior in its effect remains speculation, unsupported by the evidence. In the absence of economic analysis, the available data suggests that the custom insole is substantially more expensive to the NHS. This study, to determine which of two types of insole used in therapeutic shoes reduces peak pressure more in the at-risk diabetic foot, is therefore a very important topic and will provide both useful evidence for the NHS podiatry services. It is of course also very important for patients with diabetes as the personal suffering of those undergoing amputation is immense.~The study is a single blind randomised controlled trial comparing custom made with 'off the shelf' insoles.", - "NCTID": "NCT00999635" - }, - { - "brief_title": "Becaplermin Gel for MARTORELL's Hypertensive Leg Ulcers", - "phase": "Phase 3", - "drugs": "['becaplermin gel', 'Duoderm Hydrogel\u2122']", - "drugs_list": [ - "becaplermin gel", - "Duoderm Hydrogel\u2122" - ], - "diseases": "[\"MARTORELL'S ULCER\", 'Hypertensive Leg Ulcer', 'Necrotic Angiodermatitis']", - "diseases_list": [ - "MARTORELL'S ULCER", - "Hypertensive Leg Ulcer", - "Necrotic Angiodermatitis" - ], - "enrollment": "64.0", - "inclusion_criteria": "inclusion criteria: \n\n patients 18 years of age or older, able to give informed consent and to follow the treatment procedure \n\n target ulcer area between 1 and 30 cm2 \n\n consecutive patients presenting with one or more leg ulcers diagnosed as hypertensive MARTORELL's ulcers \n\n presence of an arterial hypertension, according to the WHO criteria, treated or not; and/or presence of a diabetes treated by oral agent, insulin or diet \n\n absence of clinical signs of chronic venous insufficiency: skin hyperpigmentation, lipodermatosclerosis \n\n absence of significant peripheral arterial occlusive disease: presence of peripheral pulses or ankle brachial index \u22650.8 \n\n absence of clinical sign of arterial insufficiency: intermittent claudication, resting pain \n\n superficial spreading necrotic ulcer \n\n presence of spontaneous pain \n\n presence of a red purpuric margin \n\n ", - "exclusion_criteria": ": \n\n pregnancy \n\n allergy to hydrogel or to becaplermin gel \n\n uncontrolled or evolving systemic disease: cardiac or renal failure, hepatic insufficiency, malignant disease, thrombotic disease, vasculitis or other connective tissue disorder \n\n presence of a cryoglobulinemia \n\n serum creatinine concentration greater than 200\u00b5mol/L or uncontrolled diabetes (fasting blood glucose > 2,5 g/L under treatment) \n\n concomitant treatment by ILOMEDINE \n\n bone, joint or tendon (except for achilles tendon) exposition in the wound \n\n systemic treatment with corticosteroid agents or cytotoxic drugs in the past 3 months before inclusion", - "brief_summary": "Background: No medical treatment has proved its efficacy for the treatment of hypertensive leg ulcers in a well designed trial.~Primary aim of the study: to compare the rate of healing in hypertensive leg ulcers treated with becaplermin gel (Regranex Gel\u00ae) daily application versus the application of the same quantity of an hydrogel (Duoderm Hydrogel\u2122), corresponding to the excipient of becaplermin gel.~Method: Ambulatory or hospitalized patients presenting with an hypertensive leg ulcer, were randomized to receive either a daily application of becaplermin gel or hydrogel during 8 weeks. At week 8, a pinch graft was proposed to patients whom the ulcer has not healed.~Primary aim of the study: Complete closure at week 8~Secondary aims: percentage of wound area reduction at week 8, complete closure at week 12, pain and quality of life during treatment~Study hypothesis: becaplermin gel may promote the healing of hypertensive leg ulcers and be an alternative medical treatment to the skin graft usually proposed", - "NCTID": "NCT00970697" - }, - { - "brief_title": "Achilles Tendon Lengthening in Patients With Diabetes to Prevent Foot Ulcers", - "phase": "Phase 1", - "drugs": "['Achilles tendon-lengthening surgery']", - "drugs_list": [ - "Achilles tendon-lengthening surgery" - ], - "diseases": "['Diabetes Mellitus', 'Foot Ulcer', 'Peripheral Neuropathy']", - "diseases_list": [ - "Diabetes Mellitus", - "Foot Ulcer", - "Peripheral Neuropathy" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n History of Diabetes Mellitus \n\n Limitation of dorsiflexion ankle range of motion to zero degrees or less \n\n Recurrent or nonhealing ulcer (Grade II, Wagner scale) \n\n ", - "exclusion_criteria": ": \n\n Nonambulatory patients or those that would not benefit from the Achilles lengthening procedure. \n\n Patients with a history of CVA or other significant neurological problems complicating their rehabilitation. \n\n Patients with a history of midfoot or hindfoot Charcot fractures. \n\n Patients with an Ankle-Arm index < 0.45 or absolute toe pressure < 40 mm Hg. \n\n Patients medically unfit for the anesthesia required for this Achilles lengthening procedure.", - "brief_summary": "People with diabetes often develop severe skin problems (ulcers) on their feet. Sometimes these are treated with surgery and other times by temporarily immobilizing the foot in a cast. This study compares the effect of surgery to lengthen the Achilles tendon and put the foot in a cast, to using a cast alone. The study will also examine how foot strength, joint movement, and overall ability to walk, balance and climb stairs is affected.", - "NCTID": "NCT00006426" - }, - { - "brief_title": "Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration", - "phase": "", - "drugs": "['cast vs. shoe']", - "drugs_list": [ - "cast vs. shoe" - ], - "diseases": "['Neuropathic Foot Ulceration in Individuals With Diabetes']", - "diseases_list": [ - "Neuropathic Foot Ulceration in Individuals With Diabetes" - ], - "enrollment": "43.0", - "inclusion_criteria": "inclusion criteria: \n\n confirmed diabetes \n\n neuropathic ulcer grade 1/2 (wagner scale) \n\n confirmed sensory neuropathy \n\n ", - "exclusion_criteria": ": \n\n osteomyelitis patients unable to walk \n\n life threatening co-morbidity ankle/brachial index , 0.4", - "brief_summary": "Objective: to compare the effectiveness of irremovable total contact casts and custom made temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes", - "NCTID": "NCT00304733" - }, - { - "brief_title": "Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers", - "phase": "Phase 2", - "drugs": "['ALLO-ASC-DFU', 'Standard therapy']", - "drugs_list": [ - "ALLO-ASC-DFU", - "Standard therapy" - ], - "diseases": "['Diabetic Foot Ulcer']", - "diseases_list": [ - "Diabetic Foot Ulcer" - ], - "enrollment": "59.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject is between 18 years and 80 years of age. \n\n Subject is diagnosed with Type I or Type II diabetes, and had defined as diabetic foot ulcers presence of wound for more than 4 weeks at the screening visit. \n\n Ulcer located the foot, and ulcer size is between 1 cm^2 and 25 cm^2. \n\n Ulcer extends into the dermis, subcutaneous tissue, tendon or joint capsule (Wagner grade 1 or 2). \n\n Ulcer is free of necrotic debris. \n\n Subjects had adequate circulation to ulcer as documented by one of the methods below: \n\n Palpation of pulses around ulcer using Doppler exam \n\n Ankle Brachial index (ABI) values ranging between 0.7 and 1.3, or \n\n Transcutaneous Oxygen Pressure (TcPO2) > 30 mmHg. \n\n Subject is able to give written informed consent prior to study start and to comply with the study requirements. \n\n ", - "exclusion_criteria": ": \n\n Ulcer is of non-diabetic pathophysiology. \n\n The ulcer has increased or decreased in size by 30% or more during one week after the screening visit. \n\n Subject is Human Immunodeficiency Virus (HIV) positive. \n\n Subjects with severe hepatic deficiencies. \n\n Subjects with a glycated hemoglobin A1c (HbA1c) level of > 15%. \n\n Subject who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue. \n\n Subjects requiring intravenous (IV) antibiotics to treat the index wound infection. \n\n Subjects with severe renal deficiencies that is uncontrolled by dialysis \n\n Subjects who are pregnant or breast-feeding. \n\n Subjects who are unwilling to use an effective method of contraception during the study. \n\n Current evidence of severe infection including pus drainage from the wound site. \n\n Subjects who have a clinically relevant history of alcohol or drugs abuse. \n\n Subject's blood sugar is > 450 mg/dL at postprandial. \n\n Subjects who are not able to understand the objective of this study or to comply with the study requirements. \n\n Subjects who are considered to have a significant disease which can impact the study by the investigator. \n\n Subjects who are considered not suitable for the study by the investigator. \n\n Subjects who have a history of surgery for malignant tumor within the last five years (except carcinoma in situ). \n\n Subjects who are currently or were enrolled in another clinical study within 60 days of screening. \n\n Subjects who have undergone wound treatments with cell therapy, dermal substitutes, or other biological therapies within the last 30 days. \n\n Subjects who are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents to unstable dosage.", - "brief_summary": "This is a phase II single-blinded study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to standard therapy.", - "NCTID": "NCT02619877" - }, - { - "brief_title": "Effectiveness of XCell on Autolytic Debridement of Venous Ulcers", - "phase": "", - "drugs": "['XCell cellulose wound dressing', 'Impregnated gauze dressing']", - "drugs_list": [ - "XCell cellulose wound dressing", - "Impregnated gauze dressing" - ], - "diseases": "['Venous Ulcer']", - "diseases_list": [ - "Venous Ulcer" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients of any race and are between 18 and 90 years of age. \n\n Patients that are able to understand and are willing to give written informed consent. \n\n Patients that have a non-healing open venous ulcer for at least one month. \n\n Patients that have greater than 50% of the ulcers surface area covered with non-viable tissue such as fibrin slough, dry crust or a combination of both. \n\n Patients that have the clinical signs and symptoms of venous ulceration such as varicosities, hyper pigmentation, stasis dermatitis, lipodermatosclerosis, and edema. \n\n Patients that have a venous ulcer with a surface area of greater than or equal to 1.5 cm2. \n\n Patients that have an ankle to brachial index (ABI) > 0.70. \n\n ", - "exclusion_criteria": ": \n\n Study wound (target ulcer) etiology is other than venous insufficiency. \n\n Patient has peripheral arterial disease as determined by the following criteria: Ankle/Brachial Index < 0.7 (ulcerated leg), evidence of intermittent claudication. \n\n Patient has the presence of any of the following in the area of the ulcer: cellulitis, osteomyelitis, and ulcer with exposed bone, tendon or fascia. \n\n Patient has a known hypersensitivity to dressing components. \n\n Patient is receiving corticosteroids, immunosuppressive agents, radiation therapy, or chemotherapy where in the investigator's opinion could interfere with wound healing . \n\n Patient is known to have uncontrolled diabetes mellitus (as defined by the investigator). \n\n Patient is known to have immunodeficiency disorders that interfere with wound healing. \n\n Patient has a history of sickle cell anemia, thalassemia, vasculitis, rheumatoid arthritis, lupus erythematosus, polyarteritis nodosa, scleroderma or any connective tissue or collagen vascular disorder. \n\n Patient has wounds that have been treated with an investigational product within the past thirty days. \n\n Patient has not signed the informed consent.", - "brief_summary": "This clinical trial is designed to evaluate the effect of XCell cellulose wound dressing for its ability to naturally (autolytically) remove nonviable tissue and create a healthy vascular wound bed. Results will compare venous ulcers treated with Xylos XCell cellulose dressing plus standard care to those treated with standard care alone. The hypothesis is that XCell will demonstrate more autolytic debridement than the standard of care.", - "NCTID": "NCT00446823" - }, - { - "brief_title": "Brief Alcohol Intervention to Reduce At-Risk Drinking Among Type 2 Diabetics", - "phase": "", - "drugs": "['Brief alcohol intervention', 'General health education']", - "drugs_list": [ - "Brief alcohol intervention", - "General health education" - ], - "diseases": "['At-risk Drinking', 'Type 2 Diabetes']", - "diseases_list": [ - "At-risk Drinking", - "Type 2 Diabetes" - ], - "enrollment": "92.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years or older, \n\n have Type 2 diabetes, \n\n report at-risk drinking in past month, \n\n report poor diabetes treatment adherence. \n\n ", - "exclusion_criteria": ": \n\n current alcohol dependence or current psychoactive substance abuse or dependence (excluding nicotine), \n\n currently psychotic, \n\n unable to provide the name and contact information for a significant other to corroborate self-report, \n\n unable to provide the name and contact information for two people who could serve as locators, do not have access to a telephone.", - "brief_summary": "This study is designed to test an intervention to reduce at-risk drinking among Type 2 diabetic patients. At-risk drinking is associated with inferior diabetes treatment adherence and control. The investigators hypothesize that our brief alcohol intervention will result in a reduction in drinking and better diabetes treatment adherence and control. If successful, this intervention could help diabetics to gain better control of their diabetes and live healthier lives.", - "NCTID": "NCT00950040" - }, - { - "brief_title": "A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk", - "phase": "", - "drugs": "['Prevention Diabetic Foot Ulcer']", - "drugs_list": [ - "Prevention Diabetic Foot Ulcer" - ], - "diseases": "['Diabetic Foot Ulcers']", - "diseases_list": [ - "Diabetic Foot Ulcers" - ], - "enrollment": "750.0", - "inclusion_criteria": "Diabetic patients with foot ulcers", - "exclusion_criteria": "", - "brief_summary": "This project will identify risk factors for diabetic foot ulcer by studying the relationship between endothelial dysfunction and foot ulcer risk. A fundamental defect in type 1 and 2 diabetic subjects is impaired vasodilatory reserve which is reflected in the dysfunction of endothelium-dependent vasodilation. Findings thus far point to an important role of the microvasculature in the development of diabetic foot ulcer and amputation.~In this study a a well-characterized cohort of 750 diabetic veterans without foot ulcer will be followed over 3-years.", - "NCTID": "NCT00013286" - }, - { - "brief_title": "MEDIHONEY\u00ae Gel Versus Collagenase for Wound Debridement", - "phase": "", - "drugs": "['Active Leptospermum Honey (Medihoney)', 'Collagenase']", - "drugs_list": [ - "Active Leptospermum Honey (Medihoney)", - "Collagenase" - ], - "diseases": "['Ulcer', 'Wounds']", - "diseases_list": [ - "Ulcer", - "Wounds" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n A signed and dated informed consent has been obtained from the subject. \n\n Subject is able and willing to comply with study procedures. \n\n Subject is able to comply with weekly visits. \n\n Subject is 18 years of age or older. \n\n There is presence of at least 50% or greater necrotic tissue (including slough and eschar) in the wound bed and a total wound surface area of > 1cm2 to < 64cm2. \n\n Subject will not have currently used parenteral or oral antibiotics except for UTI. \n\n Diabetic subjects: HbA1c < 12.0 % within 90 days preceding enrollment. \n\n Pre-albumin greater than 16 mg/dl within 90 days preceding enrollment. \n\n Subject with a pressure ulcer must be currently receiving adequate pressure redistribution to the affected area via group 2 or 3 specialty bed, a static wheel chair cushion while patient is out of bed. \n\n Subject with diabetic plantar surface ulcer will use an offloading boot if ambulatory. \n\n Subject with a venous ulcer must be currently receiving and using compression therapy that can be managed daily. \n\n Subject and caregiver are trainable and able to perform dressing changes. \n\n Subject has no allergies to collagenase or honey. \n\n Subject has no allergies to semi-occlusive or absorptive secondary dressing. \n\n If subject has multiple wounds only the wound that fits the inclusion criteria will be selected. If more than one wound meets criteria then the largest wound will be selected. \n\n ", - "exclusion_criteria": ": \n\n Steroid use >5mg daily. \n\n Subject is unable to cooperate with offloading and/or compression recommendations. \n\n ABI = or >0.8 if the wound is located on a lower extremity. \n\n Wound has the presence of callus requiring sharp or surgical debridement within 3 days prior to randomization and/or needs debridement using any method other than the study agent throughout study treatment. \n\n Subject has medical instability as deemed by the investigator. \n\n Subject is pregnant. \n\n Subject has participated in another clinical trial or wound dressing evaluation in the 30 days prior to enrollment.", - "brief_summary": "The purpose of this study is to compare how well two products, Active Leptospermum Honey (ALH) (MEDIHONEY\u00ae Gel) and Collagenase (Santyl\u00ae), in removing the nonviable (non living) tissue.", - "NCTID": "NCT02482948" - }, - { - "brief_title": "Dynamic Plantar Microvascular Skin Response to Compressive Loads in At-risk Diabetic and Healthy Control: a Pilot Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Foot Ulcer, Diabetic']", - "diseases_list": [ - "Foot Ulcer", - "Diabetic" - ], - "enrollment": "18.0", - "inclusion_criteria": "inclusion criteria: \n\n between ages 40 and 75 \n\n history of diabetic neuropathic plantar ulcer (test subjects) \n\n no history of diabetes (control subjects) \n\n no peripheral sensory neuropathy (control subjects) \n\n ", - "exclusion_criteria": ": \n\n amputation or surgery on right Great Toe", - "brief_summary": "The purpose of this pilot study is to compare the dynamic response of microcirculation in the skin on the bottom of the big toe after applying controlled plantar stress in 25 diabetic subjects with a history of foot ulcer and 25 age-matched healthy controls to better understand the role of local hypoxia in neuropathic foot ulceration in subjects with diabetes.~The investigators hypothesize that if they apply a gait simulating load to the plantar foot and measure microvascular function, diabetic individuals will demonstrate an increased delay in reestablishing microvascular flow compared to healthy individuals.", - "NCTID": "NCT01580917" - }, - { - "brief_title": "Abnormal Structure and Bone Density in Diabetes", - "phase": "", - "drugs": "['Radiography', 'Urine and Blood sampling', 'Echography']", - "drugs_list": [ - "Radiography", - "Urine and Blood sampling", - "Echography" - ], - "diseases": "['Type 1 Diabetes', 'Type 2 Diabetes']", - "diseases_list": [ - "Type 1 Diabetes", - "Type 2 Diabetes" - ], - "enrollment": "79.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult with type 1 or 2 diabetes with or without neuropathy \n\n ", - "exclusion_criteria": ": \n\n Pathology affecting bone metabolism: \n\n abnormalities of phosphate metabolism proved biologically hepatic, \n\n chronic alcoholism \n\n renal insufficiency (creatinine clearance < 60 ml / min) \n\n hyperthyroidism, \n\n intoxication active smoking, \n\n occlusive arteritis of lower limbs (IPS > IPS 1.2 or < 0.9) \n\n Treatment affecting bone metabolism (corticosteroids or glitazones for over 3 months in the year or bisphosphonates within 6 months) \n\n Known HIV positive serology \n\n Progressive, inflammatory disease (rheumatoid arthritis, ankylosing spondylitis, bowel inflammatory)", - "brief_summary": "Assumptions and Objectives: The working hypotheses are: 1 - subjects with type 1 diabetes and / or type 2, compared to subjects without diabetes are at risk for osteopenia and / or abnormal bone structure the foot (calcaneus and ankle) can lead to bone deformities, fractures and final stage of Charcot foot. These anomalies are favored by the presence of peripheral neuropathy and plasma levels of advanced glycation end products higher than in diabetic subjects without bone abnormalities.~The objectives of this research are to evaluate these anomalies quantitative and qualitative bone in the foot (calcaneus and ankle) through the use of MicroScanner. In parallel a whole body bone mineral density (BMD) and calcaneal ultrasound will be performed to measure bone mineral density as realized in clinical practice in a defined population of patients with type 1 or type 2. These bone abnormalities will be correlated with the presence of peripheral neuropathy and the rate of advanced glycation end products of proteins and reference to parameters of chronic inflammation and oxidative stress to better understand the pathophysiology and target a population at risk.~The importance of this study is paramount in the management of diabetic foot. Indeed for the moment we are dealing primarily the consequences of diabetes impact bone when bone deformities have appeared with their attendant disability and the risk of recurrent infections in areas of friction in this fragile environment. The ultimate goal is to target people with diabetes have abnormal bone subclinical and take care to avoid changes to bone deformities and find ways to treat them.", - "NCTID": "NCT01094899" - }, - { - "brief_title": "The Effect of Hyperbaric Chamber Treatment on Patients With Diabetic Retinopathy", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Does Hyperbaric Chaber Treatment Improve Diabetic Retinopathy']", - "diseases_list": [ - "Does Hyperbaric Chaber Treatment Improve Diabetic Retinopathy" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n inclusion criteria: \n\n Patients between ages 18-90 with Diabetes type I or II and diabetic retinopathy who are scheduled for hyperbaric treatment for other indications than DR. \n\n Patients who signed an informed consent form and agree to undergo an ophthalmic physical examination, Fundus photography and OCT prior to hyperbaric treatment and oCT exam following every 10 treatments in hyperbaric chamber. Total number of hyperbaric treatments will be conducted according to the main indication for which they have been assigned this treatment. \n\n ", - "exclusion_criteria": ": \n\n Patients with Carotid stenosis of more than 70% \n\n Anemia of < 10mg/Dl \n\n Patients with chest X ray pathology which cannot be admitted to hyperbaric chamber treatment. \n\n Patients with claustrophobia or that cannot decompress properly. \n\n Patients with any malignant disease \n\n Patients with inability to sign informed consent \n\n Decompression treatment will last 90 minutes in 2 atmospheres pressure with 100% oxygen. \n\n -", - "brief_summary": "Diabetic retinopathy (DR) is a common complication of diabetes and is divided into non proliferative DR and proliferative DR. The damage is caused by either macular edema, macular ischemia that can be followed by vascular proliferation.~Hyperbaric chamber treatment assists in increasing the amount of oxygen in the plasma and in the tissues and has been proven to be beneficial in treating different wounds in diabetic patients but its effect hasn't been tested in diabetic retinopathy yet.~This study will recruit 40 diabetic patients who are scheduled for hyperbaric treatment due to different indications such as chronic wounds or radiation damages and who also have diabetic retinopathy. These patients will undergo opthalmic physical examination including fundus photography and OCT (Optical Coherence Tomography - optical IR retinal photography). Screening for these patients will be conducted at the Hyperbaric chamber at Assaf Harofe Medical Center for all diabetic patients prior to their first treatment.", - "NCTID": "NCT02235935" - }, - { - "brief_title": "Maggot Therapy for Wound Debridement", - "phase": "Phase 3", - "drugs": "['application of wound dressing made of bio-bags (vitapads) containing maggots', 'application of classical hydrogel/alginate wound dressing']", - "drugs_list": [ - "application of wound dressing made of bio-bags (vitapads) containing maggots", - "application of classical hydrogel/alginate wound dressing" - ], - "diseases": "['Pressure Ulcers']", - "diseases_list": [ - "Pressure Ulcers" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n patient between 18 and 90 years old \n\n patients with a non-healing fibrinous wound \u2264 40cm2 (pressure ulcer or venous ulcers \n\n pressure ulcers were less than 2cm-deep \n\n limb wounds were venous ulcers with an ankle-brachial pressure (ABP)\u2265 0.8 \n\n signed informed consent \n\n ", - "exclusion_criteria": ": \n\n patients pregnant or lactating \n\n patients with neuropathy \n\n patients perforant ulcer of the foot \n\n patients with dementia", - "brief_summary": "The main objective of the trial was to study the efficacy of bagged larvae on wound debridement in comparison to classical treatments. The secondary outcome was to assess wound healing, treatment related pain, microbiological modifications, adverse events, comfort of the dressing and duration of wound care. We performed a randomized, double-blind, multicenter, controlled, prospective phase III trial in three referral institutional centers of hospitalized care in Caen, Lisieux and Lyon, France. A total of 120 patients with a non-healing fibrinous wound \u2264 40cm2, less than 2cm-deep, and an ankle-brachial pressure index (ABPI) \u2265 0.8 were included, from March 2005 to December 2008. During two weeks\u00b4 hospitalization, patients received either Maggot Debridement Therapy (MDT, changes of bagged larvae twice a week) or classical treatments (mechanical debridement and classical dressings performed three times a week). At discharge, classical dressings were applied and a follow-up visit performed at D30. Main outcome measure was the comparison of the reduction of fibrin percentage on wounds treated with MDT and classical treatments at D15. The percentages of fibrin were measured using a computerized planimetry software package, Canvas (ACD Systems, British Columbia, Canada), which enables the quantification of color surface variations in a wound after manual delimitation (using a mouse) on a series of photographic images.", - "NCTID": "NCT01211236" - }, - { - "brief_title": "DEC033 Study Product for Mild to Moderate Eczema An Open-label, Adaptive-design Pilot Study", - "phase": "Phase 1", - "drugs": "['DEC033 Study Product']", - "drugs_list": [ - "DEC033 Study Product" - ], - "diseases": "['Eczema']", - "diseases_list": [ - "Eczema" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy male or female \u2265 18 and \u2264 70 years of age. \n\n Body mass index (BMI) \u2265 20 and \u2264 35 kg/m2. \n\n Subjects with mild to moderate eczema; determined at screening visit. \n\n Judged by the Investigator to be in general good health on the basis of medical history. \n\n Agree to use the Study-supplied cleanser and moisturizer as the only body cosmetic applied to irritated skin. \n\n Agree to stop all medications and supplements during the entire length of the study \n\n Females of child bearing potential must agree to use appropriate birth control methods during the entire study period. \n\n Agree not to initiate any new exercise or diet programs during the entire study period. \n\n Agree not to change their current diet or exercise program during the entire study period. \n\n Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator. \n\n ", - "exclusion_criteria": ": \n\n Clinically significant renal, hepatic, endocrine (including diabetes mellitus), cardiac, pulmonary, pancreatic, neurologic, hematologic, or biliary disorder. \n\n Known allergy or sensitivity to Herbal products. \n\n History or presence of cancer in the prior two years, including any skin cancer or suspicious lesions. \n\n Recent history of alcoholism (within 12 months) or strong potential for alcohol or substance abuse. \n\n Participation in a clinical study with exposure to any non-registered drug product within 30 days prior. \n\n Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk. Including subjects who are Bed or wheelchair-bound. \n\n Pregnant, lactating, or unwilling to use adequate contraception during the duration of the study. \n\n Smoking - must be nonsmoker for at least 12 weeks prior to screening.", - "brief_summary": "This open-label, adaptive design study was designed to determine the efficacy of the study product in the treatment of eczema which would be assessed by the reduction of the appearance of skin lesions and symptoms associated such as itching, scaling and redness.", - "NCTID": "NCT02379507" - }, - { - "brief_title": "Restore Calcium Alginate Dressing, Silver vs Aquacel Ag in the Treatment of Critically Colonized Venous Leg Ulcers", - "phase": "Phase 4", - "drugs": "['Restore Calcium Alginate Dressing', 'AquaCel Ag Wound Dressing']", - "drugs_list": [ - "Restore Calcium Alginate Dressing", - "AquaCel Ag Wound Dressing" - ], - "diseases": "['Venous Ulcer', 'Infection']", - "diseases_list": [ - "Venous Ulcer", - "Infection" - ], - "enrollment": "19.0", - "inclusion_criteria": "inclusion criteria: \n\n Is 18 years or older; male or female. \n\n Previous diagnosis of venous insufficiency proven by a positive venous duplex with reflux. \n\n Has a venous ulcer with a wound area between 5 cm2 - 40 cm2. \n\n Has an ankle brachial index (ABI) >0.8. \n\n Has a venous ulcer with duration less than 24 months. \n\n Has a venous ulcer which is critically colonized (not infected) based on the Lazareth Study Model. Ulcers are considered to be critically colonized if at least three of the five following signs are present: \n\n Severe spontaneous pain between two dressing changes,Perilesional erythema,Local edema,Malodour,Heavy Exudation \n\n Is currently using Profore as their standard of care. \n\n Has not received antibiotics for 6 weeks prior to enrollment. \n\n ", - "exclusion_criteria": " \n\n Has an allergy to one of the components of the dressings (calcium alginate, hydrocolloid [carboxymethylceullose], silver). \n\n Is currently on antibiotics. \n\n Has a negative venous duplex. \n\n Is unable to tolerate 4 layer compression. \n\n Is unable to continue contact with the investigator for a period of at least two weeks. \n\n Is unwilling or unable to comply with the study protocol.", - "brief_summary": "Calcium alginate dressings with silver have been found to be safe and effective for use for leg ulcers. The primary objective is to compare Restore Calcium Alginate Dressing, Silver to AqualCel Ag Dressing on the following parameters: No further progression toward infection (bioburden), ease of application and removal, and percent progression to closure. The secondary objective is to obtain photographic documentation of the leg ulcers during the course of the study.", - "NCTID": "NCT01396304" - }, - { - "brief_title": "Non-Healing Ulcers Without Critical Limb Ischemia", - "phase": "Phase 2", - "drugs": "['Angioplasty of the lower limbs vessels']", - "drugs_list": [ - "Angioplasty of the lower limbs vessels" - ], - "diseases": "['Peripheral Artery Disease Without Critical Limb Ischemia']", - "diseases_list": [ - "Peripheral Artery Disease Without Critical Limb Ischemia" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients need to be at least 18 years old \n\n Patients have to be admitted to the university hospitals of Geneva for a non-healing lower limb ulcer. \n\n - Eligible patients are those presenting with non-healing lower limb ulcers for more than 3 months. \n\n Patients will be hospitalized in the Dermatology inpatient clinic. \n\n Patients had to benefit from at least one thin skin autograft at the ulcer level in the past or during the index hospitalization. \n\n Before inclusion in the study, patients must undergo complete angiological diagnostic work-up including: \n\n A baseline ABI, toe pressure and tcPO2 measurements, \n\n A non-invasive arterial imaging including an angio-CT scan or an angio-MRI, \n\n The non-invasive arterial work-up must revel mild to moderate PAD, without any criteria or sign of CLI (see flow-chart): \n\n Ankle pressure \u2265 50 mmHg, \n\n + ABI: < 0.9 or > 1.3, \n\n \u00b1 Toe pressure : 30-100 mmHg \n\n \u00b1 tcPO2: 20-40 mmHg, \n\n At this moment the patient may be included in the study protocol. \n\n All patients presenting with mild to moderate PAD and evidence of at least 1 impaired arterial vessel targeting the ulcer will initially undergo conservative impatient clinic care for at least 2-4 weeks and benefit from at least 1 thin skin autograft. \n\n Persisting surface of lower limb ulcers will be assessed 1 month later: \n\n -- In the presence of a healed ulcer surface > 70%, the patient will undergo 6 months of clinical follow up at 1-3-6 months. \n\n 1. In case of persistence of healed ulcer surface > 70% clinical success will be achieved. \n\n 2. In presence of healed ulcer surface < 70% the patient will undergo a new angiological work-up. \n\n If mild to moderate PAD will be again outlined the patient will join the < 70% healed ulcer group. \n\n On the other hand, if CLI will be pointed out lower limb revascularisation and at least one thin skin autograft will be performed. \n\n -- In presence of a healed ulcer surface < 70%, endovascular PTA and at least one thin skin autograft will be performed. The ulcers healing will then be monitored at 1-3-6 months and persisting ulcers surface re-assessed: \n\n in presence of an healed ulcer surface > 70% clinical success will be achieved, \n\n if presence of an healed ulcer surface < 70% clinical failure will be retained. \n\n ", - "exclusion_criteria": ": \n\n Patients who refused to give their written informed consent. \n\n Patients, in whom the angiological work-up shows the presence of a CLI, mandating a revascularization procedure attempt (i.e. ankle pressure < 50mmHg, toe pressure < 30mmHg, tcPO2 < 20mmHg) (see particular situation n\u00b02). \n\n Patients who do not present with peripheral artery disease (i.e., ABI > 0.9 - < 1.3, TP > 100mmHg, tcPO2 > 40mmHg). \n\n Patients in whom the angiological-dermatological work-up shows the presence of another reversible cause of the non-healing ulcer: \n\n - Special attention will be given to the presence of a treatable venous insufficiency (e.g. compression stocking, varices stripping), an underlying inflammatory/infectious process (treatable with antibiotics or topic-systemic antiinflammatory medications) or other reversible mechanical factors (unadapted shoes, etc.). \n\n Patients without any significant lesion of the arterial tree (ilio-femoro-popliteal and infra-popliteal): \n\n - In case there will be a single BTK vessel disease not perfusing the ulcer area (e.g. pre-tibial ulcer with a significant stenosis of the posterior tibial artery which does not perfuse the ulcer region), the patient will not be included in the study because any significant ulcer improvement would be expected from this non-target vessel revascularization. \n\n Patients in whom the scheduled revascularization procedure will be judged too risky for the patient's safety: \n\n Chronic kidney failure (= Creatinin Clearance < 20ml/min) with an increased risk of contrast induced nephropathy, \n\n Too complex arterial disease or anatomy, in which the estimated procedural technical success rate is < 50% (i.e. complex chronic total occlusion). \n\n Patients in whom an amputation is unavoidable, despite any revascularization attempt (e.g. extensive skin necrosis [Rutherford class 6]), - If, it will be estimated that, a successful revascularization procedure may reduce the level of amputation, or if a successful intervention may improve the amputation's healing process, the patient may be included in the study.", - "brief_summary": "Background: Lower limb arterial revascularization procedures, either percutaneously or surgically performed, are an established treatment modality of ischemic foot ulcers, especially in the setting of a critical limb ischemia. Many other lower limb ulcers are secondary to a combined disease, which may include a concomitant venous disease (chronic venous insufficiency or varicous disease) or a micro-angiopathic disease (i.e. small vessel disease). In this setting, and especially in the absence of a concomitant severe macro-angiopathic disease, the safety and efficacy of a percutaneous lower limb revascularization have so far never been evaluated in a prospective study.~Aim: This study is aimed to evaluate the safety and the efficacy of an endovascular revascularization approach of the lower limb, in all consecutive patients presenting with a non-healing ulcer associated with a mild to moderate peripheral artery disease (i.e. mixed-origin ulcers).~Material and methods: This prospective study will consecutively include all patients presenting with a non-healing ulcer. Included patients must have all the concomitant ulcer co-factors being adequately treated for at least 6 months. Accordingly, an underlying venous disease, infectious disease or inflammatory disorder must be previously evaluated and adequately treated (i.e. compression stocking, varices stripping, antibiotics, local \u00b1 systemic anti-inflammatory, etc.). Furthermore, a non-invasive arterial evaluation must be obtained in all patients. The arterial screening must included an ankle-brachial index (ABI) and toe pressure (TP) measurements, a trans-cutaneous oxygen measurement (tcPO2) at the foot and calf levels and a non-invasive arterial mapping (i.e. angio-CT or angio-MRI). This arterial work-up must be compatible with the presence of a mild to moderate peripheral artery disease without any sign or criteria suggesting the presence of a critical limb ischemia.~End-points: The success rate of perform an endovascular revascularization intervention in all consecutive patients which qualify according to the inclusion criteria (technical feasibility). Establish the proportion of procedural related complications (safety). Analyze the clinical and the para-clinical improvements in term of heal of the ulcers, as well as the improvement of the ABI, TP, tcPO2 at 1 week, 1-3-6 months after the procedure (efficacy).~Sample size: The investigators plan to include \u2248 30 patients in two years. After 1 year of enrollment the investigators will perform an interim analysis and will decide at that moment, according to the observed end-points, if prolonging the study would be of any scientific value or if the study has to be interrupt earlier because of a significant improvement of all already treated ulcers.", - "NCTID": "NCT01666093" - } - ], - "2": [ - { - "brief_title": "Plantar Faciitis and Diabetes Mellitus", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Diabetes Mellitus']", - "diseases_list": [ - "Diabetes Mellitus" - ], - "enrollment": "93.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of Diabetes mellitus \n\n Must be obese \n\n ", - "exclusion_criteria": ": \n\n Previous radiotherapy to the foot, \n\n previous trauma to the foot (fracture, rupture of tendon), \n\n rheumatic or vascular diseases, \n\n malign diseases, \n\n lymphatic edema.", - "brief_summary": "Obesity is a risk factor for calcaneal spur (CS) formation which is supposed to originate from chronic plantar fasciitis. Diabetes mellitus may contribute to the risk of CS by decreased ability of tissue repair and increased reactive ossification. Thus, the investigators aimed to determine CS incidence in asymptomatic obese subjects with and without type 2 diabetes mellitus (T2DM).", - "NCTID": "NCT01259206" - }, - { - "brief_title": "Skin Ulcers Treatment With an Handicraft Topical Device", - "phase": "Phase 4", - "drugs": "['drenovac handcrafted', 'Healing']", - "drugs_list": [ - "drenovac handcrafted", - "Healing" - ], - "diseases": "['Foot Ulcer', 'Varicose Ulcer']", - "diseases_list": [ - "Foot Ulcer", - "Varicose Ulcer" - ], - "enrollment": "144.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with cutaneous leg ulcers due to diabetes mellitus, venous stasis and arterial insufficiency requiring healing or tissue debrided sent to managing their disease to regional general hospital No. 17, Instituto Mexicano del Seguro Social, Benito Ju\u00e1rez, Quintana Roo. \n\n Patients of both sexes. \n\n Patients over 18 years. \n\n Patients that have basic laboratory at admission (complete blood count with differential). \n\n Patients with comorbidities associated as Diabetes Mellitus , Hypertension, stroke, heart disease, nephropathy, venous insufficiency and arterial insufficiency, etc. \n\n ", - "exclusion_criteria": ": \n\n Hemodynamically unstable patients. \n\n Patients with septic shock from any source. \n\n Patients with deep skin ulcers with exposed some organ, data osteomyelitis, vascular-nervous exposure. \n\n Patients with secondary cutaneous ulcer enteral fistula. \n\n Patients with cutaneous ulcer or cancer tumors. \n\n Patients with cutaneous ulcer with active bleeding. \n\n Patients with cutaneous ulcer necrosis. \n\n Patients with cutaneous ulcer leishmania, insect bite. \n\n Patients with cutaneous ulcer burns. \n\n Patients who do not accept their participation in the study through informed consent.", - "brief_summary": "The aim of this study was to evaluate the efficacy of a handicraft topical device of negative pressure versus traditional healing treatment for skin ulcers in lower limbs; in patients with diabetes mellitus, venous stasis and arterial insufficiency.", - "NCTID": "NCT02512159" - }, - { - "brief_title": "Evaluation of the Use of Levemir\u00ae in Insufficiently Controlled Patients With Type 1 or Type 2 Diabetes", - "phase": "", - "drugs": "['insulin detemir']", - "drugs_list": [ - "insulin detemir" - ], - "diseases": "['Diabetes', 'Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']", - "diseases_list": [ - "Diabetes", - "Diabetes Mellitus", - "Type 1", - "Diabetes Mellitus", - "Type 2" - ], - "enrollment": "4464.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with insufficiently controlled type 1 or type 2 diabetes mellitus under their previous therapy", - "exclusion_criteria": "", - "brief_summary": "This study conducted in Europe. The aim of this study is to evaluated the use of insulin detemir (Levemir\u00ae) in insufficiently controlled patients with type 1 or type 2 diabetes.", - "NCTID": "NCT01542463" - }, - { - "brief_title": "NovoLog Observation Trial in Subjects With Type 1 and Type 2 Diabetes", - "phase": "Phase 4", - "drugs": "['insulin aspart']", - "drugs_list": [ - "insulin aspart" - ], - "diseases": "['Diabetes', 'Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']", - "diseases_list": [ - "Diabetes", - "Diabetes Mellitus", - "Type 1", - "Diabetes Mellitus", - "Type 2" - ], - "enrollment": "513.0", - "inclusion_criteria": "inclusion criteria: \n\n People with Type I or Type II Diabetes \n\n 18 Years or Older.", - "exclusion_criteria": "", - "brief_summary": "This trial is conducted in the United States of America (USA). The aim of this trial is to assess control of blood sugar, safety, and patient acceptance of insulin aspart compared to insulin lispro, both in insulin pumps, in standard clinical practice.", - "NCTID": "NCT00095446" - }, - { - "brief_title": "Improving Care for Patients With Diabetes and Poor Numeracy Skills", - "phase": "", - "drugs": "['Literacy/Numeracy oriented educational intervention', 'Control Group']", - "drugs_list": [ - "Literacy/Numeracy oriented educational intervention", - "Control Group" - ], - "diseases": "['Diabetes']", - "diseases_list": [ - "Diabetes" - ], - "enrollment": "106.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of Type 1 or 2 Diabetes; \n\n most recent A1C greater than or equal to 7.0%; \n\n Referred to the Diabetes Improvement Program for diabetes care; \n\n Age 18-80; \n\n English Speaking. \n\n ", - "exclusion_criteria": ": \n\n Patients with corrected visual Acuity >20/50 using a Rosenbaum Pocket Vision Screener, or \n\n Patients with a diagnosis of significant dementia, psychosis, or blindness.", - "brief_summary": "The aim of this research will be to perform a randomized controlled trial (RCT) of a new diabetes educational intervention that teaches self-management skills that compensate for poor numeracy skills among a sample of patients with diabetes and low numeracy.", - "NCTID": "NCT00311922" - }, - { - "brief_title": "Effect of Topic Pirfenidone in Diabetic Ulcers", - "phase": "Phase 3", - "drugs": "['Pirfenidone', 'Debridement']", - "drugs_list": [ - "Pirfenidone", - "Debridement" - ], - "diseases": "['Diabetic Foot Ulcers']", - "diseases_list": [ - "Diabetic Foot Ulcers" - ], - "enrollment": "36.0", - "inclusion_criteria": "inclusion criteria: \n\n Men or women \n\n Type 1 or 2 diabetes \n\n Age \u2265 18 years \n\n Wagner 1 or 2 diabetic foot ulcer \n\n Diabetic ulcer for more than 8 weeks duration \n\n Willing to participate in the study with signed informed consent \n\n ", - "exclusion_criteria": ": \n\n Ankle/brachial index < 0.4 (critic ischemia) \n\n Use topical or systemic antibiotics \n\n Inability to attend to the weekly evaluations \n\n Inability to do daily ulcer cleansing \n\n Autoimmune diseases \n\n Active pharmacologic topical or systemic ulcer treatment \n\n Treatment with immunosuppressors such as steroids, radiotherapy, chemotherapy \n\n Pregnancy or lactation", - "brief_summary": "Pirfenidone is a synthetic molecule, which acts as a potent modulator of the effect of various cytokines (TNF-\u03b1, transforming growth factor-\u03b2, platelet derived growth factor and vascular endothelial growth factor, among others) that possesses anti-inflammatory and anti-fibrinolytic properties.~The aim of this study is to compare the effect of topic treatment with pirfenidone compared to conventional treatment in chronic diabetic foot ulcers.~The hypothesis is that treatment with topic pirfenidone in chronic diabetic foot ulcers (Wagner 1 to 2) reduces the ulcer size and shortens the healing time compared to conventional treatment. This is a randomized, controlled and crossover study. Patients will be randomly assigned to conventional treatment or topic pirfenidone for eight weeks. At the end of this period they will change groups. Each week ulcers will be for size, depth, length and evidence of infection. The ulcers will have proper debridement in the conventional treatment group and debridement plus topical pirfenidone application in the pirfenidone group. Subjects will be instructed to do daily ulcer cleansing and for those in the topical pirfenidone group, in addition to cleansing they will be instructed to apply the gel twice a day.", - "NCTID": "NCT02222376" - }, - { - "brief_title": "Hyperbaric Oxygen Therapy (HBOT) for Chronic Diabetic Lower Limb Ulcers", - "phase": "Phase 4", - "drugs": "['Hyperbaric Oxygen Therapy', 'Placebo Hyperbaric Oxygen Chamber']", - "drugs_list": [ - "Hyperbaric Oxygen Therapy", - "Placebo Hyperbaric Oxygen Chamber" - ], - "diseases": "['Diabetes Mellitus', 'Chronic Ulcers of the Lower Limb']", - "diseases_list": [ - "Diabetes Mellitus", - "Chronic Ulcers of the Lower Limb" - ], - "enrollment": "107.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 18 years \n\n Type 1 or 2 Diabetes Mellitus \n\n Wagner grading of foot lesions 3 or 4 on lower limb not healing for 4 weeks. \n\n ", - "exclusion_criteria": ": \n\n Impending urgent amputation due to ongoing or exacerbated infection; \n\n Exposed calcaneus bone with no prospect of weight bearing potential even if defect has been healed; \n\n Dialysis-dependent renal failure; \n\n Any of the following medical conditions which preclude safe treatment in a monoplace chamber: clinical depression; severe dementia; claustrophobia; seizure disorder; active asthma; severe chronic obstructive pulmonary disease; previous thoracic surgery; previous spontaneous or trauma induced pneumothorax; history of severe congestive heart failure with left ventricular ejection fraction less than 20%; unstable angina; chronic sinusitis; chronic or acute otitis media or major ear drum trauma; severe kyphoscoliosis; arthritis; or morbid obesity; \n\n History of chemotherapy with use of Bleomycin; \n\n Participation in another investigative drug or device trial currently or within the last 30 days; \n\n Current candidates for vascular surgery, angioplasty or stenting; \n\n Major large vessel disease; \n\n Undergone vascular surgery or angioplasty within the last 3 months; \n\n Women who are currently pregnant or are breast feeding or women of childbearing potential who are not currently taking adequate birth control.", - "brief_summary": "The purpose of this study is to determine if HBOT plus standard wound care is more effective than standard wound care alone at preventing the need for major amputation (metatarsal and up) in patients with diabetes mellitus (Type 1 or 2) with moderate to sever chronic wounds of lower limbs.", - "NCTID": "NCT00621608" - }, - { - "brief_title": "Efficacy of a Low-Molecular-Weight Heparin (Bemiparin) in the Treatment of Chronic Foot Ulcers in Diabetic Patients", - "phase": "Phase 2; Phase 3", - "drugs": "['bemiparin (low molecular weight heparin)']", - "drugs_list": [ - "bemiparin (low molecular weight heparin)" - ], - "diseases": "['Foot Ulcer, Diabetic', 'Diabetic Angiopathies']", - "diseases_list": [ - "Foot Ulcer", - "Diabetic", - "Diabetic Angiopathies" - ], - "enrollment": "84.0", - "inclusion_criteria": "inclusion criteria: \n\n age over 18 years; \n\n type I or II diabetes mellitus diagnosed (ADA 1998) for more than 3 years; \n\n presence of at least one cutaneous ulcer distal to the knee, not involving deep tissues (stages I and II of Wagner's classification ) and existing for at least three months; \n\n giving their written informed consent. \n\n ", - "exclusion_criteria": ": \n\n hypersensibility to heparin or pig derivatives \n\n body weight lower than 35 kg \n\n presence of clinical signs of infection that did not resolve in spite of oral antibiotics; \n\n anticoagulant therapy; \n\n severe impairment of renal or hepatic function; \n\n bleeding disorder; \n\n active peptic ulcer; \n\n arterial hypertension with poor control; \n\n pregnancy or lactation; \n\n terminal illness or a prognosis of survival under three months.", - "brief_summary": "To assess the efficacy of bemiparin (low molecular weight heparin) for 3 months in the treatment of chronic foot ulcers in diabetic patients.", - "NCTID": "NCT00399425" - }, - { - "brief_title": "A Study on the Efficacy and Safety of Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers With REGRANEX", - "phase": "Phase 3", - "drugs": "['Becaplermin']", - "drugs_list": [ - "Becaplermin" - ], - "diseases": "['Foot Ulcer', 'Diabetic Foot', 'Skin Ulcer', 'Diabetic Neuropathies']", - "diseases_list": [ - "Foot Ulcer", - "Diabetic Foot", - "Skin Ulcer", - "Diabetic Neuropathies" - ], - "enrollment": "84.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of Type I or Type II diabetes mellitus and a glycohemoglobin A1c<12% \n\n Minimum of one neuropathic, diabetic ulcer meeting the following criteria: stage III or IV, located on the distal lower extremity, between 1 and 15 square centimeters \n\n No exposed bone at the ulcer site \n\n No osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure \n\n Adequate arterial circulation to the foot \n\n New ulcers must be meet the following criteria: full-thickness ulcer (Stage III or IV), located on feet or ankles, no exposed bone at the ulcer site, no osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure \n\n Recurrent ulcers must meet the following criteria: stage II, III or IV, no exposed bone at the ulcer site, no osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure \n\n Females must be postmenopausal, surgically incapable of childbearing, or using an acceptable method of birth control and have negative pregnancy test \n\n ", - "exclusion_criteria": ": \n\n Hypersensitivity to REGRANEX\u00ae Gel or one of its components \n\n Presence of more than two full-thickness diabetic ulcers on either lower extremity \n\n presence of an active systemic or local cancer or tumor of any kind \n\n Use of topical antibiotics, antiseptics, enzymatic debriders, or any other agents on the selected ulcers, within the seven days preceding randomization \n\n Active rheumatic or collagen vascular disease or pre-existing conditions or diseases which may interfere with the evaluation of safety or efficacy of Regranex \n\n Systemic corticosteroid maintenance therapy, immunosuppressive or chemotherapeutic agents within 14 days prior to first study drug application or are likely to receive one of these therapies during study participation \n\n Radiation therapy that included the distal lower extremity, at any time in patient's life \n\n Charcot deformity (rocker bottom foot)", - "brief_summary": "The purpose of this study is to evaluate the efficacy and safety of REGRANEX\u00c2\u00ae Gel compared with placebo when applied for up to 52 consecutive weeks to recurring or non-healing ulcers of the ankle or foot related to diabetes.", - "NCTID": "NCT00034788" - }, - { - "brief_title": "Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia", - "phase": "Phase 2", - "drugs": "['Leia']", - "drugs_list": [ - "Leia" - ], - "diseases": "['Leg Ulcer', 'Diabetic Foot Ulcer', 'Pressure Ulcer']", - "diseases_list": [ - "Leg Ulcer", - "Diabetic Foot Ulcer", - "Pressure Ulcer" - ], - "enrollment": "6.0", - "inclusion_criteria": "inclusion criteria: \n\n Low to highly exuding chronic wound(wound history > 2 months) such as Leg Ulcer, Pressure Ulcer Category III to IV or Diabetic Foot Ulcer \n\n Male of female, 18 years and above \n\n Signed Informed Consent Form \n\n ", - "exclusion_criteria": ": \n\n Pregnancy or lactation \n\n Wound size not suitable for the wound dressing size \n\n Known allergy/hypersensitivity to any of the components in the dressing", - "brief_summary": "The purpose of this reseach study is to determine M\u00f6lnlycke Health Care\u00b4s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic foot ulcer.", - "NCTID": "NCT01966380" - }, - { - "brief_title": "Improving Care for Primary Care Patients With Diabetes and Poor Literacy and Numeracy Skills", - "phase": "Phase 4", - "drugs": "['Literacy/Numeracy oriented educational intervention', 'Control Group']", - "drugs_list": [ - "Literacy/Numeracy oriented educational intervention", - "Control Group" - ], - "diseases": "['Type 2 Diabetes']", - "diseases_list": [ - "Type 2 Diabetes" - ], - "enrollment": "110.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of Type 2 Diabetes \n\n most recent A1C >= 7.5% \n\n Referred to the Diabetes Care Program for diabetes care \n\n Age 18-85; 5. English Speaking. \n\n ", - "exclusion_criteria": ": \n\n Patients with corrected visual Acuity >20/50 using a Rosenbaum Pocket Vision Screener \n\n Patients with a diagnosis of significant dementia, psychosis, or blindness.", - "brief_summary": "The aim of this research will be to perform a small randomized controlled trial (RCT) of a new diabetes educational intervention that teaches self-management skills that compensate for poor numeracy skills among a sample of primary care patients with type 2 diabetes and low literacy and/or numeracy.", - "NCTID": "NCT00469105" - }, - { - "brief_title": "Hyperbaric Oxygen, Neutrophil-oxidative Burst, and Cytokines", - "phase": "Phase 1", - "drugs": "['Hyperbaric Oxygen', 'Hyperbaric Air/Oxygen', 'Normobaric oxygen']", - "drugs_list": [ - "Hyperbaric Oxygen", - "Hyperbaric Air/Oxygen", - "Normobaric oxygen" - ], - "diseases": "['Infection']", - "diseases_list": [ - "Infection" - ], - "enrollment": "40.0", - "inclusion_criteria": "Cohort 1: Diabetic hyperbaric patients with active, chronic infection \n\n inclusion criteria: \n\n Adult patients (ages 18-65) presenting for an anticipated course of at least 4 hyperbaric oxygen sessions for chronic clinical indications (possible indications include diabetic lower extremity wounds or refractory osteomyelitis) \n\n Diabetes mellitus \n\n Current antibiotic use for active infection \n\n ", - "exclusion_criteria": ": \n\n Prior treatment with hyperbaric oxygen within the last 30 days \n\n Consistent vitamin C or vitamin E supplementation in the past year \n\n Active tobacco use \n\n Pregnancy \n\n Cohort 2: Hyperbaric patients without diabetes or active infection \n\n inclusion criteria: \n\n - Adult patients (ages 18-65) presenting for an anticipated course of at least 4 hyperbaric oxygen sessions for chronic clinical indications (possible indications include crush injury, acute peripheral arterial insufficiency, or radiation necrosis) \n\n ", - "brief_summary": "In this small pilot study, participants (patients and healthy volunteers) will have blood drawn before and after the study intervention (hyperbaric chamber session or normal pressure oxygen breathing. This blood will be analyzed for neutrophil oxidative burst and cytokine analysis.", - "NCTID": "NCT02563678" - } - ] - }, - { - "patient_id": "sigir-20147", - "patient": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", - "0": [ - { - "brief_title": "Pilot Study of Cognitive Behavioral Therapy for Anxiety and Bipolar I Disorder", - "phase": "", - "drugs": "['UP CBT', 'Treatment as usual']", - "drugs_list": [ - "UP CBT", - "Treatment as usual" - ], - "diseases": "['Bipolar Disorder', 'Anxiety Disorders']", - "diseases_list": [ - "Bipolar Disorder", - "Anxiety Disorders" - ], - "enrollment": "34.0", - "inclusion_criteria": "inclusion criteria: \n\n Men and women age 18-65 \n\n DSM-IV diagnosis of bipolar I disorder and at least one of three additional anxiety disorders: \n\n generalized anxiety disorder, panic disorder, or social phobia. \n\n HAM-D-17 score <16 (i.e. depressive symptoms) \n\n YMRS score < 12 (i.e. no or very low manic symptoms) \n\n Current, stabilized (> 3 months) pharmacotherapy treatment under the care of a psychiatrist consisting of optimized, stable maintenance pharmacotherapy at maximum tolerated dosages according to Texas Implementation of Medication Algorithm. \n\n ", - "exclusion_criteria": ": \n\n Active suicidality (HAM-D-17 suicide item #3 score > 3) in the past 2 months. Potential participants scoring 3 or higher on the HAM-D-17 suicide item will be immediately evaluated by the PI and Sponsor and referred to a higher level of care if clinically indicated. \n\n DSM-IV bipolar I disorder subtype rapid cycling \n\n DSM-IV manic or mixed episode in the past 2 months \n\n DSM-IV major depressive episode in the past 2 months \n\n Psychotropic medication not in accordance with the revised Texas Implementation of Medication Algorithm \n\n Current Pregnancy \n\n Medical illness or non-psychiatric medical treatment that would likely interfere with study participation. \n\n Neurologic disorder, previous ECT, or history of head trauma (i.e. known structural brain lesion) \n\n Current or past history of selected DSM-IV Axis I disorders other than bipolar disorder including: organic mental disorder, substance abuse within the past 12 months and/or history of substance abuse for > 1 year; current substance dependence (including alcohol), as assessed by the Structured Clinical Interview for DSM-IV-TR, Substance Use Disorders (Section E); schizophrenia, delusional disorder, psychotic disorders not otherwise specified, obsessive compulsive disorder and posttraumatic stress disorder (due to low prevalence of \n\n 6.5% each). \n\n Concurrent psychotherapy other than cognitive-behavioral therapy as provided in this study (to rule out other uncontrolled effects of concurrent psychotherapies) \n\n Presence of metallic implants that would interfere with safety during fMRI scanning (i.e. cardiac pacemaker, metal plates, etc.) \n\n Claustrophobia", - "brief_summary": "The specific goal of this research study is to investigate the feasibility, acceptability, and preliminary efficacy of a transdiagnostic, cognitive-behavioral therapy developed specifically to target common core processes across mood and anxiety disorders [Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)], for the treatment of patients with bipolar I disorder (BD-I) and comorbid anxiety. The study will compare treatment-as-usual with pharmacotherapy (TAU) plus 18 one-hour sessions of treatment with the UP to TAU alone. Patients in both treatment conditions will be followed over a 12-month period and will be assessed monthly to track changes in mood, anxiety and emotion-related symptoms; functional impairment; and relapse rates. Data on the acceptability of the treatment will be gathered concurrently through monthly patient self-reported ratings of treatment satisfaction, and by tracking rates of acceptance for randomization into the study, number of completed sessions, and dropout rates. The study will examine: 1) whether combined cognitive behavioral treatment (UP) for BD-I and comorbid anxiety disorders is an acceptable and feasible approach to treatment; 2) whether treatment with the UP for BD-I and comorbid anxiety disorders as an adjunct to pharmacotherapy treatment-as-usual (TAU) leads to greater symptom reduction and reduced functional impairment than pharmacotherapy alone, 3) whether treatment for BD-I and comorbid anxiety disorders with the UP improves relapse rates over a 6-month follow-up relative to TAU; and 4) whether reduction in symptoms, relapse rates, and functional impairment are mediated by changes in emotion regulation skills. The broader aim of this study is to address the need for improved treatments for bipolar disorder.", - "NCTID": "NCT01892306" - }, - { - "brief_title": "Safety and Efficacy Study of Lithium in Bipolar Disorder", - "phase": "Phase 3", - "drugs": "['Lithium Carbonate Capsule']", - "drugs_list": [ - "Lithium Carbonate Capsule" - ], - "diseases": "['Bipolar Disorder', 'Mania']", - "diseases_list": [ - "Bipolar Disorder", - "Mania" - ], - "enrollment": "206.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of Bipolar 1 Disorder; \n\n Hospitalized or in the process of being hospitalized for a manic or mixed episode \n\n ", - "exclusion_criteria": ": \n\n History of rapid cycling; \n\n History of hypersensitivity or adverse reaction to lithium", - "brief_summary": "The purpose of this study is to determine whether Lithium is safe and effective in the treatment of Bipolar I Disorder subjects with symptoms of acute mania.", - "NCTID": "NCT00422331" - }, - { - "brief_title": "Mentalization-Based Therapy to Prevent Suicidal Behavior in Adolescents With Bipolar Disorder", - "phase": "", - "drugs": "['Mentalization-Based Therapy']", - "drugs_list": [ - "Mentalization-Based Therapy" - ], - "diseases": "['Bipolar Disorder', 'Suicidal Ideation']", - "diseases_list": [ - "Bipolar Disorder", - "Suicidal Ideation" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of Bipolar Disorder I, Bipolar Disorder II, or Bipolar Disorder Not Otherwise Specified \n\n Living with or in close contact with at least one parent who is willing to participate \n\n Have had at least 1 week in the prior 3 months of significant suicidal ideation and/or at least one suicidal event in the 3 months prior to study intake. \n\n Willing to be treated pharmacologically by a psychiatrist in the UCLA Child and Adolescent Mood Disorders (CHAMP) clinic \n\n ", - "exclusion_criteria": ": \n\n Participants requiring immediate hospitalization \n\n Diagnosis of borderline personality disorder, schizophrenia, or schizoaffective disorder. \n\n Current substance dependence disorder", - "brief_summary": "Children and adolescents with early-onset bipolar disorder (BD) are at high risk for intentionally hurting themselves. Although there are therapies in existence for these youths with BD, they do not address suicide prevention specifically. Mentalization-based therapy for adolescents (MBT-A) has been shown to be helpful in reducing self-harm in the adolescent and adult population with borderline personality disorder. The investigators will modify the MBT-A treatment procedures for persons with BD who have had a recent period of suicidal ideation or behavior.", - "NCTID": "NCT02129790" - }, - { - "brief_title": "Mindfulness Based Cognitive Therapy for Youth With Anxiety at Risk for Bipolar Disorder", - "phase": "", - "drugs": "['MBCT-C', 'Waitlist Control']", - "drugs_list": [ - "MBCT-C", - "Waitlist Control" - ], - "diseases": "['Anxiety', 'Bipolar Disorder']", - "diseases_list": [ - "Anxiety", - "Bipolar Disorder" - ], - "enrollment": "35.0", - "inclusion_criteria": "inclusion criteria: \n\n 10-17 years old \n\n At least one parent with bipolar disorder \n\n Meets clinical criteria for a specific anxiety disorder \n\n PARS -5 item scale score > 10 at screening and baseline of initial study phase \n\n Fluent in English; \n\n Provision of written informed consent/assent \n\n Agrees to participate in 75% of sessions \n\n ", - "exclusion_criteria": ": \n\n CANNOT Have any of the Following: \n\n Documented diagnosis of mental retardation or IQ <70 \n\n Previous participation in mindfulness-based treatment \n\n Substance use disorder within last 3 months \n\n Judged clinically to be suicide risk \n\n Concurrent treatment with psychotropic medication (certain exceptions apply, ask for details) \n\n Psychotherapy initiated within 2 months prior to screening or plan to initiate psychotherapy during study participation \n\n Any lifetime diagnosis of bipolar disorder, cyclothymia, schizophrenia, or other psychotic disorder \n\n Any symptom that requires admission to an inpatient psychiatric unit \n\n Anxiety symptoms resulting from acute medical illness or acute intoxication or withdrawal from drugs or alcohol", - "brief_summary": "Children who have parents with bipolar disorder are at risk for developing anxiety disorders.", - "NCTID": "NCT02090595" - }, - { - "brief_title": "Escitalopram as a Mood Stabilizer for Bipolar II Disorder", - "phase": "Phase 2", - "drugs": "['Escitalopram (Lexapro)']", - "drugs_list": [ - "Escitalopram (Lexapro)" - ], - "diseases": "['Bipolar Disorders']", - "diseases_list": [ - "Bipolar Disorders" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged 18-65 \n\n Minimum two year history of depressive and hypomanic episodes \n\n Mood episodes occuring monthly \n\n Meet DSM-IV criteria for Bipolar II Disorder (with exception of minimum 4 day period for hypomanic episodes) \n\n ", - "exclusion_criteria": ": \n\n Previous treatment with any antidepressant, mood stabilizer or neuroleptic medication \n\n History of psychotic symptoms during hypomanic or depressive episodes \n\n Current suicidal behaviours \n\n Current substantive illicit drug use or alcohol consumption \n\n Significant personality disorder \n\n Pregnancy or breastfeeding \n\n History of heart disease, liver disease, epilepsy or seizures", - "brief_summary": "This study will investigate the efficacy of Escitalopram, a Selective Serotonin Reuptake Inhibitor (SSRI) antidepressant, in the treatment of Bipolar II Disorder.~The use of antidepressants for those with bipolar disorder appears common in clinical practice but is not countenanced - at least as monotherapy - in formal treatment guidelines. This view reflects concerns about the possibility of antidepressant drugs inducing switching and rapid cycling in those with Bipolar Disorder. Although the effectiveness of treating Bipolar II patients with SSRIs has received very little attention in the literature, observations of Bipolar II patients treated with SSRIs suggest they may have general mood stabilising properties. Many patients have reported improvements not only in their depressed mood, but also a reduction in the severity, duration and frequency of hypomanic episodes.~In this proof of concept study we specifically assess whether a standard dose of an SSRI antidepressant is more effective than placebo in reducing the frequency, severity and duration of both depressive and hypomanic episodes.", - "NCTID": "NCT00156325" - }, - { - "brief_title": "Aripiprazole in Late Life Bipolar Disorder", - "phase": "Phase 4", - "drugs": "['Aripiprazole']", - "drugs_list": [ - "Aripiprazole" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Must have Bipolar disorder as confirmed by the Mini Neuropsychiatric Interview (MINI) \n\n Must be age 50 or older \n\n Must have sub-optimal response to current psychotropic management including at least one of the following: \n\n Behaviors and symptoms of irritability, agitation, mood liability or diminished ability to interact with others in their place of residence \n\n Diminished ability to take care of basic personal needs in their place of residence due to symptoms of bipolar disorder \n\n Intolerance to current psychotropic medications; and \n\n Must live in the Northeast Ohio area. \n\n ", - "exclusion_criteria": ": \n\n An unstable medical illness, or a medical illness, which in the opinion of the study investigators, is likely to affect the outcome of the study \n\n DSM-IV substance dependence (except nicotine or caffeine) within the past 3 months; or \n\n Receiving carbamazepine.", - "brief_summary": "The purpose of this research study is to analyze the effectiveness and tolerability of a new medication, aripiprazole (Abilify), in individuals age 50 years and older who have bipolar disorder (manic-depressive illness).", - "NCTID": "NCT00194038" - }, - { - "brief_title": "The Quietude Study: Quetiapine Use for Agitated Depression", - "phase": "Phase 3", - "drugs": "['Quetiapine XR', 'Escitalopram']", - "drugs_list": [ - "Quetiapine XR", - "Escitalopram" - ], - "diseases": "['Depression With Prominent Agitation']", - "diseases_list": [ - "Depression With Prominent Agitation" - ], - "enrollment": "250.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female \n\n Age 18 to 65 \n\n Outpatient at enrolment \n\n A diagnosis of major depressive disorder \n\n Baseline HAMD-17 score > 20 and HAMD Item1 score > 2 both at enrolment and baseline \n\n Significant agitation \n\n CGI-S score > 4 at screening and baseline \n\n Negative serum pregnancy test at enrolment and use of a reliable method of birth control during the study \n\n Able to understand and comply with the requirements of the study \n\n Able and willing to give meaningful informed written consent \n\n ", - "exclusion_criteria": ": \n\n Another Axis I diagnosis of primary focus within 6 months of enrolment \n\n Axis II disorder causing impact on current diagnosis \n\n Current depressive episode <4 weeks, or >12 months \n\n Substance or alcohol abuse or dependency as defined by DSM IV within 6 months of enrolment \n\n Any pervasive developmental disorder or dementing disorder \n\n Treatment with other antipsychotics, mood stabilizer or other psychoactive drugs less than 7 days prior to randomization \n\n Treatment with fluoxetine less than 28 days prior to baseline \n\n Treatment with MAO inhibitors, anxiolytic drugs in excess of 2 mg lorazepam equivalents/day. \n\n Insufficient response to more than two antidepressants during the index episode prior to study involvement \n\n Known lack of antidepressant response to quetiapine at a dose of at least 50 mg/day x 4 weeks \n\n Known lack of antidepressant response to escitalopram at a dose of at least 10 mg/day \n\n Known intolerance or hypersensitivity to quetiapine or escitalopram \n\n Treatment with Electroconvulsive therapy within 90 days prior to baseline \n\n Use of Potent P450 3A4 inhibitors or inducers within 14 days of baseline \n\n AST & ALT \u2265 3X ULN \n\n TSH \u2265 10% ULN \n\n Unstable medical condition \n\n Medical condition the would affect absorption, distribution, metabolism or excretion of study treatment \n\n Significant ECG abnormalities \n\n Pregnancy or lactation \n\n Patients with increased suicidal risks, HAM-D item 3 \u22653 or have made a suicide attempt within the past 6 months. \n\n Patients who, in the investigators opinion, will require psychotherapy (other than supportive psychotherapy) during the study period, unless psychotherapy has been ongoing for a minimum of 3 months prior to randomisation \n\n A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria: \n\n Unstable DM defined as enrolment glycosylated haemoglobin (HbA1c) >8.5%. \n\n Admitted to hospital for treatment of DM or DM related illness in past 12 weeks. \n\n Not under physician care for DM. \n\n Physician responsible for patient's DM care has not indicated that patient's DM is controlled. \n\n Physician responsible for patient's DM care has not approved patient's participation in the study \n\n Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomisation. For thiazolidinediones (glitazones) this period should not be less than 8 weeks. \n\n Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study \n\n Clinically significant deviation from the reference range in clinical laboratory test results \n\n An absolute neutrophil count (ANC) of 1.5 x 109 per liter \n\n Those who are involved in the planning and/or conduct of the study cannot be enrolled as subjects \n\n Previous enrolment or randomization in the present study \n\n Participation in another medication trial within 4 weeks prior to enrolment into the study herein", - "brief_summary": "Most individuals with major depressive disorder manifest clinically significant agitation. Concurrent agitation in a depressed individual is associated with an intensification of mood symptoms, decreased probability of recovery, increased recurrence risk, suicidality, and increased medical-service utilization. The occurrence of anxiety/agitation phenomenology in the depressed patient often invites the need for augmentation strategies (e.g. atypical antipsychotics, benzodiazepines, etc.) and complicated polypharmacy regimens. Moreover, individuals with major depressive disorder often report worsening of symptom severity, irritability, hostility, dysphoria, and significant subjective distress (This response pattern is similar to individuals with bipolar disorder).~Results from large research studies provide evidence indicating that quetiapine is capable of offering clinically significant multidimensional symptom relief in bipolar depression. Moreover, results from several trials in major depressive disorder and generalized anxiety disorder have established the efficacy of quetiapine therapy for unipolar depression and anxiety syndromes. So far, no atypical antipsychotic agent has been evaluated specifically for the treatment of agitated depression.~In this study, it is hypothesized that persons with major depressive disorder and prominent agitation (i.e. agitated depression) will exhibit a more favourable response and tolerability profile to quetiapine XR when compared to escitalopram.", - "NCTID": "NCT01363310" - }, - { - "brief_title": "Identifying Predictors of Bipolar Disorder Relapse During Pregnancy and the Postpartum Period", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Medically healthy \n\n Meets DSM-IV criteria for bipolar disorder of any subtype \n\n No more than 32 weeks gestation, dated by last menstrual period \n\n ", - "exclusion_criteria": ": \n\n Active suicidality or homicidality \n\n Acute psychotic symptoms", - "brief_summary": "This study will evaluate pregnant women who have bipolar disorder to gain a better understanding of risk factors for bipolar disorder relapse during pregnancy and the postpartum period.", - "NCTID": "NCT00720395" - }, - { - "brief_title": "Lithium for Suicidal Behavior in Mood Disorders", - "phase": "Phase 2; Phase 3", - "drugs": "['Lithium', 'Placebo']", - "drugs_list": [ - "Lithium", - "Placebo" - ], - "diseases": "['Depressive Disorder', 'Bipolar Disorder', 'Suicide', 'Suicide, Attempted']", - "diseases_list": [ - "Depressive Disorder", - "Bipolar Disorder", - "Suicide", - "Suicide", - "Attempted" - ], - "enrollment": "519.0", - "inclusion_criteria": "inclusion criteria: \n\n Must be a Veteran of the United States Armed Forces \n\n Survived an episode of suicidal self-directed violence (including suicide attempts and interrupted attempts) that occurred within six months of admission to the study, or they were admitted within the past six months to a mental health inpatient unit specifically to prevent suicide \n\n Have a diagnosis of an affective disorder meeting DSM-IV-TR (2000) criteria for Bipolar I Disorder, Bipolar II Disorder, or current or recurrent Major Depressive Disorder \n\n Are able and willing to identify one or more family members, friends, or other contacts and give permission for both clinical providers and the Research Team to contact them if the patient cannot be reached \n\n Are able to provide informed consent \n\n There is concurrence from the patient's mental health provider about inclusion/", - "exclusion_criteria": " and confirmation of the providers' willingness to work with the research team in managing the patient during the course of the study. The provider responsible for the patient's general medical care has been made aware of the participation \n\n Must be registered at a VA Medical Center \n\n ", - "brief_summary": "Observational evidence and findings from clinical trials conducted for other reasons suggest that lithium, a drug used for the treatment of bipolar disorder, and, to a lesser extent, depression, may reduce rates of suicides and suicide attempts. However, this hypothesis has not yet been adequately examined in a randomized clinical trial conducted specifically to test lithium's efficacy in preventing suicides. This clinical trial fills this gap.~This study is feasible within the Department of Veterans Affairs (VA) because it is a large, integrated health system with existing programs for identifying patients at risk for suicide and delivering enhanced services. In VA, approximately 12,000 patients with depression or bipolar disorder survive a suicide attempt or related behavior each year, and 15% of them repeat within one year. Experimental treatment in this study will supplement usual care for major depression or bipolar disorder, as well as VA's standard, enhanced management for patients at high risk.~The investigators will recruit 1862 study participants, from approximately 30 VA Hospitals. Participants will be patients with bipolar disorder or depression who have survived a recent episode of suicidal self-directed violence or were hospitalized specifically to prevent suicide. Randomly, half will receive lithium, and half will receive placebo. Neither the patients nor their doctors will know whether a particular person has received lithium or placebo. The treatment will be administered and the patients will be followed for one year, after which patients will go back to usual care. Recruitment will occur over 3 years.~The investigators are primarily interested in whether lithium leads to increases in the time to the first repeated episode of suicidal behavior, including suicide attempts, interrupted attempts, hospitalizations specifically to prevent suicide, and deaths from suicide. In addition, this study will allow us to explore whether lithium decreases the total number of suicidal behaviors, and whether it has comparable effects on impulsive and non-impulsive behaviors. If there is an effect of lithium, the investigators will be interested in whether or not it could be attributed to improved control of the underlying mental health condition, or, alternatively, whether it represents a direct effect of suicide-related behavior.", - "NCTID": "NCT01928446" - }, - { - "brief_title": "A Study of Risperidone Monotherapy in Bipolar Anxiety", - "phase": "Phase 4", - "drugs": "['risperidone (Risperdal)']", - "drugs_list": [ - "risperidone (Risperdal)" - ], - "diseases": "['Bipolar Disorder', 'Panic Disorder', 'Generalized Anxiety Disorder']", - "diseases_list": [ - "Bipolar Disorder", - "Panic Disorder", - "Generalized Anxiety Disorder" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects must be 18 years of age or older. \n\n Subjects must have lifetime bipolar I, II, or NOS disorder as defined by DSM-IV criteria. \n\n Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV criteria (except clause does not occur exclusively during a mood disorder of Criterion F for GAD) . \n\n Subjects' bipolar symptoms must be no more than moderately severe, defined as a CGI-BP < 4. \n\n Subjects' anxiety symptoms must be at least moderately severe, defined as a CGI-S > 4. \n\n Subjects must not be receiving mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for > one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for > four weeks prior to baseline. \n\n Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained. \n\n If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, double barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study. \n\n ", - "exclusion_criteria": ": \n\n Subjects who do not have lifetime bipolar disorder by DSM-IV-TR criteria. \n\n Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR criteria. \n\n Subjects who are receiving treatment with an antimanic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication. \n\n Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP > 5). \n\n Subjects whose anxiety symptoms are presently less than moderately severe (CGI < 3). \n\n Subjects with clinically significant suicidal or homicidal ideation. \n\n Subjects with current psychotic symptoms. \n\n Subjects with a current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV diagnosis of a substance dependence disorder within the past six months; a lifetime DSM-IV psychotic disorder (e.g., schizophrenia or schizoaffective disorder). \n\n Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement > 3 months. \n\n Subjects with a clinically significant abnormality in their prestudy physical exam, vital signs, EKG, or laboratory tests. \n\n Subjects who are allergic to or who have demonstrated hypersensitivity to risperidone. \n\n Women who are pregnant or nursing. \n\n Subjects who have received an experimental drug or used an experimental device within 30 days. \n\n Subjects who have a history of neuroleptic malignant syndrome.", - "brief_summary": "The specific aim of this study is to evaluate the efficacy, tolerability, and safety of risperidone monotherapy in the treatment of ambulatory bipolar disorder with comorbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.", - "NCTID": "NCT00167479" - }, - { - "brief_title": "Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder", - "phase": "Phase 4", - "drugs": "['Suvorexant', 'Placebo']", - "drugs_list": [ - "Suvorexant", - "Placebo" - ], - "diseases": "['Insomnia', 'Bipolar Disorder']", - "diseases_list": [ - "Insomnia", - "Bipolar Disorder" - ], - "enrollment": "61.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult outpatients meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder (296.70), bipolar II disorder (296.89), or bipolar disorder not otherwise specified (296.80), with concurrent insomnia related to bipolar disorder (307.42). \n\n Currently taking \u2265 1 prescription psychotropic medication (hypnotic agents, anxiolytics, atypical antipsychotics, mood stabilizers, and/or antidepressants) for management of bipolar disorder. \n\n Subjective total sleep time (sTST) < 6 hours on \u2265 1 night during the prior week. \n\n ", - "exclusion_criteria": ": \n\n Current hypo/manic symptoms, as evidenced by the Young Mania Rating Scale (YMRS) total score \u2265 12. \n\n Current (past 6 months) alcohol or substance use disorder. \n\n Current psychosis. \n\n Patients who are actively suicidal or evaluated as being a high suicide risk. \n\n Women who are currently pregnant or breastfeeding. \n\n Clinically significant abnormalities on baseline laboratory tests (comprehensive metabolic panel, fasting lipid panel, Complete Blood Count (CBC) with differential, thyroid stimulating hormone). \n\n Presence of any unstable and/or potentially confounding neurological and/or medical disorder.", - "brief_summary": "The purpose of this study is to evaluate the efficacy of suvorexant, added to existing medications, for treatment-resistant insomnia in individuals with bipolar disorder. The investigators hypothesize that participants receiving suvorexant for one week will experience significantly greater improvement in sleep duration compared to participants receiving placebo.", - "NCTID": "NCT02527564" - }, - { - "brief_title": "Antidepressant Therapy in Treating Bipolar Type II Major Depression", - "phase": "Phase 4", - "drugs": "['Venlafaxine', 'Lithium Carbonate']", - "drugs_list": [ - "Venlafaxine", - "Lithium Carbonate" - ], - "diseases": "['Bipolar Disorder', 'Depression']", - "diseases_list": [ - "Bipolar Disorder", - "Depression" - ], - "enrollment": "140.0", - "inclusion_criteria": "inclusion criteria: \n\n Meets DSM-IV criteria for Axis I bipolar II disorder \n\n Meets DSM-IV criteria for Axis I major depressive episode \n\n Score of 16 on 17-item HAM-D rating scale \n\n Not taking monoamine oxidase inhibitors (MAOI) for more than 2 weeks prior to study entry \n\n Willing to use an effective form of birth control throughout the study \n\n ", - "exclusion_criteria": ": \n\n History of mania \n\n Current primary Axis I diagnosis other than bipolar II disorder \n\n Alcohol or drug dependence within 3 months prior to study entry \n\n Contraindication to treatment with venlafaxine or lithium \n\n Unstable medical condition (e.g., thyroid disease, hypertension, or angina pectoris) \n\n Pregnant or breastfeeding \n\n Experiencing suicidal thoughts \n\n Requires hospitalization \n\n Requires concurrent neuroleptic or MS therapy \n\n Requires concurrent AD therapy \n\n Current psychotic features \n\n Inadequate trial of therapy at the time of initial screening visit \n\n History of intolerance to either venlafaxine or lithium \n\n Unlikely to participate in a 36-week trial \n\n Presence of apparent secondary gain", - "brief_summary": "This study will compare the safety and effectiveness of antidepressant therapy versus mood stabilizing therapy in treating people with bipolar type II major depression.", - "NCTID": "NCT00602537" - }, - { - "brief_title": "Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder", - "phase": "", - "drugs": "['Body Scan (BS) Meditation Intervention', 'Brief Supportive Psychotherapy (SP)']", - "drugs_list": [ - "Body Scan (BS) Meditation Intervention", - "Brief Supportive Psychotherapy (SP)" - ], - "diseases": "['Bipolar Disorder', 'Insomnia', 'Hypersomnia', 'Sleep Problems']", - "diseases_list": [ - "Bipolar Disorder", - "Insomnia", - "Hypersomnia", - "Sleep Problems" - ], - "enrollment": "48.0", - "inclusion_criteria": "inclusion criteria: \n\n Men and women age 18-65 \n\n DSM-IV diagnosis of bipolar I or II disorder \n\n HAM-D-17 score < 17 (i.e. low or no depressive symptoms) \n\n YMRS score < 8 (i.e. no or low manic symptoms) \n\n Optimized, stable maintenance pharmacotherapy at maximum tolerated dosages in accordance with the revised Texas Implementation of Medication Algorithm \n\n DSM-IV insomnia A and B criteria are met (i.e. difficulty initiating or maintaining sleep, for at least 1 month) as operationally defined by: \n\n Insomnia Severity Index score of > 15 (moderate clinical insomnia) \n\n M1 derived average actigraphic total sleep time < 6 hours, and < 40% average total sleep time in high frequency coupling, as measured with the M1 device over 5 days pre-randomization, corresponding to < 1SD below the mean of the M1 normative comparison sample of healthy control participants. \n\n ", - "exclusion_criteria": ": \n\n DSM-IV bipolar I disorder subtype rapid cycling \n\n DSM-IV manic or mixed episode in the past 2 months \n\n DSM-IV major depressive episode in the past 2 months \n\n Psychotropic medication not in accordance with the revised Texas Implementation of Medication Algorithm \n\n Pregnancy \n\n Medical illness or non-psychiatric medical treatment that is the likely cause of the sleep disturbance or interferes with study participation \n\n Neurologic disorder, previous ECT, or history of head trauma (i.e. known structural brain lesion) \n\n Current or past history of selected DSM-IV Axis I disorders other than bipolar disorder including: organic mental disorder, substance abuse within the past 12 months and/or history of substance abuse for > 1 year; past or current substance dependence (including alcohol), schizophrenia, delusional disorder, psychotic disorders not otherwise specified \n\n Axis I disorder that needs to be the primary focus of treatment (e.g. current DSM-IV anxiety disorder that disrupts sleep) \n\n Sleep apnea, restless leg syndrome, or narcolepsy \n\n Concurrent psychotherapy to BS or SP.", - "brief_summary": "The investigators propose to investigate the efficacy of a brief (4-session) Body Scan (BS) meditation intervention for individuals with bipolar I disorder with insomnia (i.e. difficulties falling or staying asleep). The investigators will compare the Body Scan intervention with a 4-session brief supportive psychotherapy (SP) intervention. The investigators hypothesize that the Body Scan will improve objective sleep quantity and quality.", - "NCTID": "NCT01764035" - }, - { - "brief_title": "Tailored Internet-delivered Cognitive Behaviour Therapy for Symptoms of Depression and Comorbid Problems", - "phase": "", - "drugs": "['Tailored Internet-delivered CBT', 'Non-tailored Internet-delivered CBT', 'Online discussion group']", - "drugs_list": [ - "Tailored Internet-delivered CBT", - "Non-tailored Internet-delivered CBT", - "Online discussion group" - ], - "diseases": "['Depression', 'Anxiety Disorders']", - "diseases_list": [ - "Depression", - "Anxiety Disorders" - ], - "enrollment": "121.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of Major Depressive Disorder \n\n 15 or more on MADRS-S \n\n ", - "exclusion_criteria": ": \n\n Severe depression (more than 35 on MADRS-S or based on interview) \n\n Severe psychiatric condition (e.g. psychosis or bipolar disorder) \n\n Changed medication during the last three months", - "brief_summary": "The overall aim of this study is to develop and test a tailored Internet-delivered psychological treatment for patients with mild to moderate major depression and comorbid anxiety symptoms and compare its efficacy to a non-tailored treatment and to an active control group.", - "NCTID": "NCT01181583" - }, - { - "brief_title": "Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified(OL Study)", - "phase": "Phase 4", - "drugs": "['olanzapine', 'lithium']", - "drugs_list": [ - "olanzapine", - "lithium" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n major depressive episode in type2 bipolar disorder or bipolar disorder NOS.(MADRS more than 20 point) \n\n 18years to 65years \n\n subjects who sign the informed consent document \n\n ", - "exclusion_criteria": ": \n\n don't have Diabetes and abnormal metabolism of sugar \n\n not noticed as bipolar disorder \n\n have an organic brain disease \n\n pregnant or breastfeeding women \n\n don't have heart disease \n\n have actively suicidal thought(Suicidal ideation score of MADRS is 6) \n\n who are judged by the investigator to should be excluded from the study", - "brief_summary": "Determine the efficacy and tolerability of olanzapine for treatment of acute depression in patients with bipolar II or bipolar disorder NOS compared with lithium.", - "NCTID": "NCT02287259" - }, - { - "brief_title": "Effectiveness of Family-Focused Treatment Plus Pharmacotherapy for Bipolar Disorder in Adolescents", - "phase": "Phase 3", - "drugs": "['Family-Focused Treatment Plus Pharmacotherapy', 'Enhanced Care Plus Pharmacotherapy']", - "drugs_list": [ - "Family-Focused Treatment Plus Pharmacotherapy", - "Enhanced Care Plus Pharmacotherapy" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "145.0", - "inclusion_criteria": "inclusion criteria: \n\n Between the ages of 13 years, 0 months and 17 years, 11 months \n\n Meets The Diagnostic and Statistical Manual of Mental Disorders - IV criteria for either of the following conditions: bipolar I or bipolar II disorder with a manic, mixed, or hypomanic episode within 3 months of study entry; or a depressed episode within 3 months of study entry with a prior history of a manic, hypomanic, or mixed episode (if the participant only meets criteria for a current hypomanic episode, there must also be a history of at least one prior depressive, manic, or mixed episode) \n\n Has experienced severe depression, hypomania, or mania symptoms for a period of at least 1 week within the 3 months prior to study entry \n\n Lives with at least one biological or step-parent who is available and willing to participate in treatment (parents not currently living with the adolescent participant may also participate) \n\n ", - "exclusion_criteria": ": \n\n Currently in full recovery (experienced minimal symptoms for at least 8 continuous weeks) \n\n Meets Diagnostic and Statistical Manual of Mental Disorders, IV criteria for substance abuse disorder or substance dependence disorder within 3 months of study entry (based on the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version ) \n\n Meets current criteria for bipolar, not otherwise specified, or substance-induced mood disorder \n\n Diagnosis of mental retardation, autism, or organic central nervous system disorder \n\n Severe, unremitting psychosis that is unresponsive to neuroleptic medications, and has lasted more than 3 months \n\n Requires extended inpatient treatment (although participant can be hospitalized at the time of intake into the study) \n\n Current life-threatening eating disorder, neurological condition, or other medical problem that requires immediate treatment \n\n Exhibits or expresses serious homicidal tendencies \n\n Victim of current sexual or physical abuse by parents or is in an environment marked by domestic violence among the parents or step-parents", - "brief_summary": "This study will evaluate the effectiveness of family-focused treatment (FFT) plus pharmacotherapy in treating adolescents with bipolar disorder.", - "NCTID": "NCT00332098" - }, - { - "brief_title": "Effect of Ketamine vs. Active Placebo on Suicidal Ideation in Depressed Inpatients With Major Depressive Disorder or Bipolar Depression.", - "phase": "Phase 1", - "drugs": "['Ketamine', 'Midazolam', 'Treatment as usual (TAU)']", - "drugs_list": [ - "Ketamine", - "Midazolam", - "Treatment as usual (TAU)" - ], - "diseases": "['Major Depressive Disorder', 'Bipolar I Disorder', 'Bipolar II Disorder', 'Bipolar Depression', 'Suicidal Ideation']", - "diseases_list": [ - "Major Depressive Disorder", - "Bipolar I Disorder", - "Bipolar II Disorder", - "Bipolar Depression", - "Suicidal Ideation" - ], - "enrollment": "9.0", - "inclusion_criteria": "inclusion criteria: \n\n Provision of written informed consent \n\n [MDD stream only] Diagnosis of major depressive disorder, currently depressed as determined by DSM-IV diagnostic criteria (confirmed using the MINI) \n\n [BD stream only] Diagnosis of bipolar disorder, type I or type II, currently depressed as determined by DSM-IV diagnostic criteria (confirmed using the MINI) \n\n Both females and males, aged 18 to 65 years \n\n Inpatient status \n\n Female patients of childbearing potential must have a negative urine human chorionic gonadotropin (hCG) test at enrolment and must be taking or willing to take some acceptable form of birth control during the course of the study if they are or plan to be sexually active \n\n The ability to understand and comply with the requirements of the study and capable of providing informed consent \n\n Suffering from suicidal ideation/attempts as evidenced by a score of >0 on either of the SSI or CSSRS or both. \n\n ", - "exclusion_criteria": ": \n\n Current or past psychotic symptoms \n\n Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria \n\n Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrollment \n\n Any pervasive developmental disorder (according to DSM-IV criteria) \n\n Diagnosis of dementia (according to DSM-IV criteria) \n\n Known intolerance or hypersensitivity to ketamine or midazolam as judged by the investigator \n\n Significant medical condition that would contraindicate the use of ketamine, midazolam or that is untreated and would need urgent attention (as determined by treating physician) \n\n Medical conditions that would significantly affect absorption, distribution, metabolism, or excretion of ketamine or midazolam \n\n Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator \n\n Any clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator \n\n Pregnancy (or female of child-bearing age not using adequate contraception) or lactation \n\n A positive \u03b2-hCG test at enrollment \n\n Involvement in the planning and conduct of the study \n\n Previous enrollment or randomisation of treatment in the present study \n\n Participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements", - "brief_summary": "Depression and suicidal ideation/attempt/death are major causes of morbidity and mortality from psychiatric illnesses. In 2009, the World Health Organization listed depression as the leading cause of years lost due to disability worldwide. Suicide is the 9th most common cause of death in Canada with 1.6% of Canadians ultimately dying from suicide (Statistics Canada, 2012) and the 2nd most common cause of death in young people after accidental deaths. This information highlights the importance of finding treatments to prevent suicidal deaths.~Ketamine has been shown to provide rapid treatment response for major depressive episodes both in major depressive disorder (MDD) and bipolar disorder (BD), via a single intravenous infusion which persists for at least 72 hours.~The purpose of this study is to conduct a pilot trial of IV ketamine + treatment as usual (TAU) vs. midazolam (an active placebo) + TAU to estimate sample size for a full-scale RCT examining these treatments for decreasing suicidal ideation among depressed inpatients with major depressive disorder and bipolar depression.~A total of 52 patients will be recruited for this trial. All subjects will be inpatients at Sunnybrook Health Sciences Centre with a diagnosis of either major depressive disorder or bipolar disorder type I or II currently depressed. Suicidal ideation must be present at baseline assessment in order to be included in the study. Thirteen subjects will be randomized to each treatment arm in each treatment stream - that is, 13 will be recruited to ketamine + TAU in the major depressive disorder stream, and 13 will be recruited to the midazolam + TAU in the major depressive stream. Likewise, 26 subjects with bipolar depression will be randomized to these two treatments.", - "NCTID": "NCT02593643" - }, - { - "brief_title": "Study of Risperidone Monotherapy in Ambulatory Bipolar Disorder With Concurrent Moderately Severe Anxiety and Lifetime Panic or Generalized Anxiety Disorder", - "phase": "Phase 3", - "drugs": "['Risperidone']", - "drugs_list": [ - "Risperidone" - ], - "diseases": "['Bipolar Disorder', 'Anxiety Disorder']", - "diseases_list": [ - "Bipolar Disorder", - "Anxiety Disorder" - ], - "enrollment": "111.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects must be 18 years of age or older. \n\n Subjects must have lifetime bipolar I, II, or NOS disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria. \n\n Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV criteria (except clause does not occur exclusively during a mood disorder of Criterion F for GAD) . \n\n Subjects' bipolar symptoms must be no more than moderately severe, defined as a CGI-BP < 4. \n\n Subjects' anxiety symptoms must be at least moderately severe, defined as a CGI-S > 4. \n\n Subjects must not be receiving mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for > one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for > four weeks prior to baseline. \n\n Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained. \n\n If female, subjects must be: \n\n postmenopausal, \n\n surgically incapable of childbearing, \n\n or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study. \n\n ", - "exclusion_criteria": ": \n\n Subjects who do not have lifetime bipolar disorder by DSM-IV-TR (text revision) criteria. \n\n Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR criteria. \n\n Subjects who are receiving treatment with an antimanic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication. \n\n Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP > 5). \n\n Subjects whose anxiety symptoms are presently less than moderately severe (CGI < 3). \n\n Subjects with clinically significant suicidal or homicidal ideation. \n\n Subjects with current psychotic symptoms. \n\n Subjects with a current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV diagnosis of a substance dependence disorder within the past six months; or a lifetime DSM-IV psychotic disorder (e.g., schizophrenia or schizoaffective disorder). \n\n Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement > 3 months. \n\n Subjects with a clinically significant abnormality in their prestudy physical exam, vital signs, EKG, or laboratory tests. \n\n Subjects who are allergic to or who have demonstrated hypersensitivity to risperidone. \n\n Women who are pregnant or nursing. \n\n Subjects who have received an experimental drug or used an experimental device within 30 days. \n\n Subjects who have a history of neuroleptic malignant syndrome.", - "brief_summary": "The purpose of this research study is to evaluate the safety, tolerability, and efficacy (how well the drug works) of risperidone compared to placebo (an inactive drug) in the treatment of bipolar disorder with panic disorder or generalized anxiety disorder. Risperidone is currently approved by the United States Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar mania. Risperidone is not currently FDA approved for the treatment of bipolar hypomania with or without panic disorder or generalized anxiety disorder (the condition being investigated in this study).", - "NCTID": "NCT00277654" - }, - { - "brief_title": "Characteristics of Sleep Patterns in Young Adults With and Without Insomnia", - "phase": "Phase 4", - "drugs": "['Zolpidem', 'Escitalopram', 'Placebo']", - "drugs_list": [ - "Zolpidem", - "Escitalopram", - "Placebo" - ], - "diseases": "['Sleep Disorders']", - "diseases_list": [ - "Sleep Disorders" - ], - "enrollment": "69.0", - "inclusion_criteria": "inclusion criteria: \n\n Physically healthy \n\n Meets DSM-IV criteria for primary insomnia \n\n For subjects interested in PET study only: right-handedness \n\n ", - "exclusion_criteria": ": \n\n Currently taking antidepressants, antianxiety medications or medications for sleep disorders \n\n Currently experiencing symptoms of psychiatric disorders such as major depressive disorder, bipolar disorder, generalized anxiety disorder \n\n Significant or unstable acute or chronic medical conditions, such as seizure disorder, tumor, liver disease, active peptic ulcer disease, arthritis, irritable bowel disease \n\n Meets DSM-IV criteria for sleep apnea or periodic limb movement disorder", - "brief_summary": "This study will compare the symptoms, experiences, and laboratory sleep characteristics of young adults with and without insomnia.", - "NCTID": "NCT00177216" - }, - { - "brief_title": "Dialectical Behavior Therapy (DBT) for Adolescents With Bipolar Disorder", - "phase": "", - "drugs": "['Dialectical Behavior Therapy', 'Standard of Care Psychotherapy', 'Pharmacotherapy']", - "drugs_list": [ - "Dialectical Behavior Therapy", - "Standard of Care Psychotherapy", - "Pharmacotherapy" - ], - "diseases": "['Dialectical Behavior Therapy + Pharmacotherapy', 'Standard of Care Psychotherapy + Pharmacotherapy']", - "diseases_list": [ - "Dialectical Behavior Therapy + Pharmacotherapy", - "Standard of Care Psychotherapy + Pharmacotherapy" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: For the proposed study, inclusion criteria are as follows: 1) age 12 years, 0 months to 18 years, 11 months; 2) a diagnosis of Bipolar Disorder (BP) I, II or NOS by the K-SADS-PL with an acute manic, mixed or depressive episode in the 3 months preceding study entry; 3) willing to engage in pharmacotherapy treatment at the CABS specialty clinic; 4) at least one parent or guardian with whom the patient lives or interacts on a significant basis (5 hours per week or more) who is willing to participate in DBT skills training; 5) English language fluency and at minimum a 3rd grade literacy level; 6) able and willing to give informed consent/assent to participate. \n\n ", - "exclusion_criteria": ": For the proposed study, ", - "brief_summary": "Of all psychiatric diagnoses, bipolar disorder imparts the greatest risk for completed suicide in adolescence, and is further associated with poor psychosocial functioning, substance abuse and legal difficulties, and exorbitant healthcare costs exceeding those for other adolescent psychiatric conditions. Treatment guidelines indicate optimal management of pediatric bipolar disorder includes a combination of medication and psychotherapy. Yet, little is known about effective psychotherapy approaches for this population, and none expressly target suicidality. An efficacious, cost-effective psychosocial intervention for adolescents with bipolar disorder has great potential to decrease the substantial morbidity, mortality and costs associated with adolescent bipolar disorder.", - "NCTID": "NCT02003690" - }, - { - "brief_title": "Retrain Your Brain in Children/Adolescents With Bipolar Disorder: A Pilot Study", - "phase": "Phase 1", - "drugs": "['COGFLEX-skill building levels', 'COGFLEX-control condition']", - "drugs_list": [ - "COGFLEX-skill building levels", - "COGFLEX-control condition" - ], - "diseases": "['Bipolar Disorder', 'Pediatric Bipolar Disorder', 'Childhood-onset Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder", - "Pediatric Bipolar Disorder", - "Childhood-onset Bipolar Disorder" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n 7-17 years old \n\n bipolar disorder type I preferred (at least 1 week of mania) \n\n ", - "exclusion_criteria": ": \n\n no implanted metal (no braces, no cochlear implants) \n\n can not have full Diagnostic and Statistical Manual 4th Edition (DSM-IV) autistic disorder \n\n no active drug/alcohol abuse/dependence", - "brief_summary": "The main aim of this study is to test a new, non-medication computer-based potential treatment for bipolar disorder in children and adolescents.~In the study, children and adolescents with bipolar disorder will come to our lab at Bradley Hospital 2-times per week for 8-weeks to play a custom computer game designed to retrain the brain--to build a skill that my work has shown is impaired in children/adolescents with bipolar disorder.~Before and after this 8-week trial, children will have a special magnetic resonance imaging (MRI) scan.~This is a test of feasibility--meaning we want to see if the 8-week trial results in brain changes.~If it does, we will conduct a second study to see if it improves how bipolar children function--i.e., if it helps their illness.", - "NCTID": "NCT01954680" - }, - { - "brief_title": "Randomized, Placebo-controlled Multicenter Trial of Lithium Plus Treatment as Usual (TAU) for Acute Suicidal Ideation and Behavior in Patients With Suicidal Major Depressive Episode", - "phase": "", - "drugs": "['Lithium Carbonate', 'Placebo']", - "drugs_list": [ - "Lithium Carbonate", - "Placebo" - ], - "diseases": "['Suicidal Ideation/Behavior', 'Depression']", - "diseases_list": [ - "Suicidal Ideation/Behavior", - "Depression" - ], - "enrollment": "254.0", - "inclusion_criteria": "inclusion criteria: \n\n Major depressive episode; inpatient at screening visit; suicidal ideation/behaviour present defined by a clinical rating of 8 on the Sheehan Suicidality Tracking Scale (S-STS) and a rating of \u226520 on the Montgomery Asberg Depression Scale (MADRS) at both screening and baseline visits; both gender, age 18 years. \n\n ", - "exclusion_criteria": ": \n\n Contraindication for and history of lithium treatment within the past 6 months; patient unable to tolerate lithium treatment in the past; comorbid borderline/antisocial personality disorder, currently active substance dependency; patients with acute or unstable severe medical conditions, patients unable to understand the informed consent or involuntary inpatients, positive toxicology screen (illegal drugs), pregnancy and lactation", - "brief_summary": "The primary hypothesis of this confirmatory study is that lithium therapy will acutely decrease suicidal ideation and/or suicidal behaviour in inpatients with a major depressive episode (MDE, unipolar and bipolar disorder according to DSM IV criteria). The specific aim is to test the hypothesis that lithium plus treatment as usual (TAU), compared to placebo plus TAU, results in a significantly greater decrease in suicidal ideation and/or behaviour over 5 weeks in inpatients with MDE.", - "NCTID": "NCT02039479" - }, - { - "brief_title": "Lithium Therapy: Understanding Mothers, Metabolism and Mood", - "phase": "", - "drugs": "['Lithium']", - "drugs_list": [ - "Lithium" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "9.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 or older \n\n If Pregnant, equal to or less than 26 weeks \n\n English-speaking \n\n DSM-IV Bipolar Disorder, any subtype, Major Depressive Disorder, or Mood Disorder Not Otherwise Specified \n\n Able to provide informed consent \n\n Daily dosing of lithium \n\n ", - "exclusion_criteria": ": \n\n Active substance abuse within last 6 months and/or positive urine drug screen \n\n Active suicidality \n\n No obstetrical care \n\n Use of other drugs that affect metabolism of lithium \n\n Medications in FDA categories F or X that are not antimanic drugs \n\n Chronic Kidney Disease", - "brief_summary": "Lithium, the gold standard for treatment of Bipolar Disorder (BD) and a common augmentation to medication therapy for Major Depression, is commonly continued in pregnancy due to its therapeutic benefit and more recent data that suggests the teratogenic effects of lithium are less than historically believed. Due to the increased elimination of lithium during pregnancy, lithium concentration decreases in the blood and women with BD are vulnerable to BD episode recurrence in pregnancy. Uncontrolled symptoms of BD in pregnancy increase the risk for postpartum exacerbation of BD and psychosis. Our study will investigate the pharmacokinetics (PK) of lithium prior to pregnancy, during pregnancy, and postpartum. Twenty women taking lithium in pregnancy or planning to become pregnant and continue lithium will be invited to participate in a study to measure repeated blood levels of lithium at six time points between preconception and 3 months postpartum. The data collected will inform the dose, timing of dose, and frequency of dosing of lithium that will lead to fewer untoward effects for the mother and baby. Change in elimination clearance of lithium will be correlated with symptom worsening to develop a dosing algorithm that will help maintain wellness for pregnant women with mood disorders.", - "NCTID": "NCT02490241" - }, - { - "brief_title": "Zonegran in the Treatment of Binge Eating Disorder Associated With Obesity", - "phase": "Phase 3", - "drugs": "['Zonegran', 'sugar pill']", - "drugs_list": [ - "Zonegran", - "sugar pill" - ], - "diseases": "['Binge Eating Disorder Associated With Obesity']", - "diseases_list": [ - "Binge Eating Disorder Associated With Obesity" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients will meet DSM-IV criteria for BED for at least the last 6 months. These criteria are as follows: \n\n Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following: (1) eating, in discrete period of time (eg, within any two hour period), an amount of food that is definitely larger than most people would eat in a similar period of time under similar circumstances and (2) a sense of lack of control over eating during the episode (eg, a feeling that one cannot stop eating or control what or how much one is eating) \n\n The binge eating episodes are associated with at least three of the following: \n\n Eating much more rapidly than normal \n\n Eating until uncomfortably full \n\n Eating large amounts of food when not feeling physically hungry \n\n Eating alone because of being embarrassed by how much one is eating \n\n Feeling disgusted with oneself, depressed, or feeling very guilty after overeating \n\n Marked distress regarding binge eating. \n\n The binge eating occurs, on average, at least two days a week for six months. \n\n Does not occur exclusively during the course of bulimia nervosa and anorexia nervosa. \n\n Obesity as defined by body mass index > 30 kg/m2. \n\n Men or women, between the ages of 18 and 65. The patient population is expected to be predominantly made up of women based on previous research. \n\n ", - "exclusion_criteria": ": \n\n Have current body mass index < 30kg/m2. \n\n Women who are pregnant or lactating and women of childbearing potential who are not taking adequate contraceptive measures. If there is a possibility a female subject might be pregnant, a pregnancy test will be performed. (All women of childbearing potential will have a negative pregnancy test before entering the study.) \n\n Subjects who are displaying clinically significant suicidality or homicidality. \n\n Subjects who are displaying a current clinically unstable depressive disorder (e.g., HAM-D > 21). \n\n A current or recent (within 6 months of the start of study medication) DSM-IV diagnosis of substance abuse or dependence. \n\n A lifetime history of a DSM-IV bipolar disorder or dementia. \n\n History of a personality disorder (eg, schizotypal, borderline, or antisocial) which might interfere with assessment or compliance with study procedures. \n\n Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease which could interfere with diagnosis, assessment, or treatment of binge eating disorder. Patients should be biochemically euthyroid prior to entering the study. \n\n History of seizures, including febrile seizures in childhood \n\n History of clinically significant nephrolithiasis. \n\n Subjects requiring treatment with any drug which might interact adversely with or obscure the action of the study medication (e.g. stimulants, sympathomimetics, antidepressants, carbonic anhydrase inhibitors, anti-obesity drugs). \n\n Subjects who have received psychoactive medication (other than zaleplon [Sonata] or zolpidem [Ambien] -- as needed for restlessness/insomnia) within one week prior to randomization. \n\n Subjects who have begun and/or are receiving formal psychotherapy (cognitive behavioral therapy, interpersonal therapy, or dietary behavioral therapy) for BED or weight loss within the past 3 months. \n\n Subjects previously enrolled in this study or have previously been treated with zonisamide. \n\n Subjects who have received an experimental drug or used an experimental device within 30 days.", - "brief_summary": "The specific aim of this study is to examine the efficacy and safety of zonisamide compared with placebo in outpatients with binge eating disorder associated with obesity.", - "NCTID": "NCT00221442" - }, - { - "brief_title": "Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder(GAD)", - "phase": "Phase 4", - "drugs": "['Ziprasidone', 'Placebo']", - "drugs_list": [ - "Ziprasidone", - "Placebo" - ], - "diseases": "['Bipolar Disorder', 'Panic Disorder', 'Generalized Anxiety Disorder']", - "diseases_list": [ - "Bipolar Disorder", - "Panic Disorder", - "Generalized Anxiety Disorder" - ], - "enrollment": "49.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects must at least age of 18 years of age and not older than 65. \n\n Subjects must have lifetime bipolar I, II, or NOS disorder as defined by DSM-IV TR criteria (26). \n\n Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV criteria (except clause does not occur exclusively during a mood disorder of Criterion F for GAD). \n\n Subjects' bipolar symptoms must be no more than moderate in severity, defined as a CGI-BP< 4 (27). \n\n Subjects' anxiety symptoms must be at least moderate in severity, defined as a CGI-S > 4 (28). \n\n Subjects must not be receiving regular mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for at least one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for at least four weeks prior to baseline. \n\n Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained. \n\n If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study. \n\n ", - "exclusion_criteria": ": \n\n Subjects who do not have lifetime bipolar disorder by DSM-IV-TR criteria (26). \n\n Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR criteria (26). \n\n Subjects who are receiving treatment with an anti-manic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication. \n\n Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP > 5) (27). \n\n Subjects whose anxiety symptoms are presently less than moderately severe (CGI-S < 3) (28). \n\n Subjects with clinically significant suicidal or homicidal ideation. \n\n Subjects with a current DSM-IV TR Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV TR diagnosis of a substance dependence disorder within the past six months; a lifetime DSM-IV TR psychotic disorder (e.g., schizophrenia or schizoaffective disorder). \n\n Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurological, or hematological disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement > 3 months. \n\n Subjects with a clinically significant abnormality in their pre-study physical exam, vital signs, EKG, or laboratory tests. \n\n Subjects who are allergic to or who have demonstrated hypersensitivity or intolerance to ziprasidone. \n\n Women who are pregnant or nursing. \n\n Subjects who have received an experimental drug or used an experimental device within 30 days. \n\n Subjects who have a history of neuroleptic malignant syndrome. \n\n A patient with diabetes mellitus (DM) fulfilling one of the following criteria: \n\n Unstable DM defined as enrollment glycosylated hemoglobin (HbAlc) >8.5% \n\n Admitted to hospital for treatment of DM or DM related illness within the past 12 weeks \n\n Not under physician care for DM \n\n Physician responsible for patient's DM care has not indicated that the patient's DM is controlled \n\n Physician responsible for patient's DM care has not approved the patient's participation in the study \n\n Has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks before randomization. For thiazolidinediones(glitazones)this period should not be less than 8 weeks before randomization. \n\n Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks \n\n Note: If a patient with DM meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study", - "brief_summary": "The specific aim of this study is to evaluate the efficacy, tolerability, and safety of ziprasidone monotherapy in comparison to placebo in the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.", - "NCTID": "NCT01172652" - }, - { - "brief_title": "Special Drug Use Investigation for LAMICTAL Bipolar", - "phase": "", - "drugs": "['Lamotrigine tablets']", - "drugs_list": [ - "Lamotrigine tablets" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "1036.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with bipolar disorder \n\n Patients treated with lamotrigine tablets for the first time \n\n ", - "exclusion_criteria": ": \n\n Not applicable", - "brief_summary": "This post-marketing surveillance study is designed to collect and assess information on safety and effectiveness of lamotrigine tablets in patients with bipolar disorder in routine clinical practice.~(LAMICTAL is a trademark of the GlaxoSmithKline group of companies.)", - "NCTID": "NCT01428518" - }, - { - "brief_title": "Prevention of Weight Gain in Early Psychoses", - "phase": "", - "drugs": "['Behavioural Intervention for the Prevention of Weight Gain', 'TAU']", - "drugs_list": [ - "Behavioural Intervention for the Prevention of Weight Gain", - "TAU" - ], - "diseases": "['Schizophreniform Disorder', 'Bipolar I Disorder', 'Bipolar II Disorder', 'Major Depressive Disorder', 'Substance-Induced Psychoses', 'Psychosis Not Otherwise Specified', 'Schizophrenia', 'Schizoaffective Disorder']", - "diseases_list": [ - "Schizophreniform Disorder", - "Bipolar I Disorder", - "Bipolar II Disorder", - "Major Depressive Disorder", - "Substance-Induced Psychoses", - "Psychosis Not Otherwise Specified", - "Schizophrenia", - "Schizoaffective Disorder" - ], - "enrollment": "70.0", - "inclusion_criteria": "inclusion criteria: \n\n Age between 14 and 45 years (inclusive) \n\n Male or Female gender \n\n DSM-IV-TR diagnosis of Schizophrenia, Schizoaffective disorder,Schizophreniform Disorder, Bipolar Disorder (Type I),Bipolar Disorder (Type II), Major Depressive Disorder With Psychotic Features, Substance-Induced Psychoses, Psychosis Not-Otherwise-Specified (NOS) \n\n Outpatient status at the time of randomization \n\n Duration of antipsychotic treatment of less than 5 years \n\n Ability to provide informed consent \n\n Female patients of childbearing potential must be using a medically accepted means of contraception \n\n Treatment with olanzapine, clozapine, quetiapine,risperidone or paliperidone for less than 8 weeks duration at enrollment \n\n BMI between 18.5 and 30 \n\n ", - "exclusion_criteria": ": \n\n Inability to give informed consent \n\n Currently enrolled in a weight management program \n\n Currently being treated with a medication to reduce weight \n\n Patients with unstable or active cardiovascular illnesses (myocardial infarction, congestive heart failure, etc), active or end-stage renal disease, and unstable thyroid disease, etc \n\n Inclusion/", - "brief_summary": "The purpose of this study is to determine whether individuals with psychotic spectrum disorders ( Schizophrenia, Schizoaffective disorder,Schizophreniform Disorder, Bipolar Disorder (Type I),Bipolar Disorder (Type II),Major Depressive Disorder With Psychotic Features,Substance-Induced Psychoses,Psychosis Not-Otherwise-Specified (NOS)randomly assigned to a stepped behavioral intervention for the prevention of weight gain will experience less weight gain than individuals who receive usual care. There are several studies that have examined the effect of pharmacological and non-pharmacological behavioural approaches for weight loss in patients with psychosis, however studies examining strategies for prevention of obesity are lacking. This study is an important and novel approach to studying the problem of obesity in those with psychosis.", - "NCTID": "NCT01075295" - }, - { - "brief_title": "Quetiapine SR and Divalproex Sodium ER in the Treatment of Anxiety in Bipolar Disorder With Panic Disorder and/or GAD", - "phase": "Phase 4", - "drugs": "['quetiapine SR', 'divalproex sodium ER', 'placebo']", - "drugs_list": [ - "quetiapine SR", - "divalproex sodium ER", - "placebo" - ], - "diseases": "['Bipolar Disorder', 'Panic Disorder', 'Generalized Anxiety Disorder']", - "diseases_list": [ - "Bipolar Disorder", - "Panic Disorder", - "Generalized Anxiety Disorder" - ], - "enrollment": "224.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects must be at least 18 years of age and not older than 65 \n\n Subjects must have lifetime bipolar I, II, or not otherwise specified (NOS) disorder as defined by DSM-IV TR (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision) criteria \n\n Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV, criteria (except clause does not occur exclusively during a mood disorder of Criterion F for GAD) \n\n Subjects' bipolar symptoms must be no more than moderate in severity, defined as a CGI-BP< 4 \n\n Subjects' anxiety symptoms must be at least moderate in severity, defined as a CGI-S > 4 \n\n Subjects must not be receiving regular mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for at least one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for at least four weeks prior to baseline \n\n Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained \n\n If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study \n\n ", - "exclusion_criteria": ": \n\n Subjects who do not have lifetime bipolar disorder by DSM-IV-TR criteria \n\n Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR criteria \n\n Subjects who are receiving treatment with an anti-manic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication \n\n Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP>5) \n\n Subjects whose anxiety symptoms are presently less than moderately severe (CGI-S<3) \n\n Subjects with clinically significant suicidal or homicidal ideation. \n\n Subjects with a current DSM-IV TR Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV TR diagnosis of a substance dependence disorder within the past six months; a lifetime DSM-IV TR psychotic disorder (e.g., schizophrenia or schizoaffective disorder) \n\n Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurological, or hematological disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo-or hyperthyroidism unless stabilized on thyroid replacement > 3 months \n\n Subjects with a clinically significant abnormality in their pre-study physical exam, vital signs, EKG, or laboratory tests \n\n Subjects who are allergic to or who have demonstrated hypersensitivity or intolerance to either of the active study medications \n\n Women who are pregnant or nursing \n\n Subjects who have received an experimental drug or used an experimental device within 30 days \n\n Subjects who have a history of neuroleptic malignant syndrome \n\n A patient with diabetes mellitus (DM) fulfilling one of the following criteria: \n\n Unstable DM defined as enrollment glycosylated hemoglobin (HbAlc) >8.5% \n\n Admitted to hospital for treatment of DM or DM related illness within the past 12 weeks \n\n Not under physician care for DM \n\n Physician responsible for patient's DM care has not indicated that the patient's DM is controlled \n\n Physician responsible for patient's DM care has not approved the patient's participation in the study \n\n Has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks before randomization. For thiazolidinediones (glitazones) this period should not be less than 8 weeks before randomization \n\n Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks Note: If a patient with DM meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study", - "brief_summary": "The specific aim of this study is to evaluate the efficacy, tolerability, and safety of quetiapine SR monotherapy and divalproex sodium ER monotherapy in comparison to placebo in the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.", - "NCTID": "NCT00579280" - }, - { - "brief_title": "Development of an Insomnia Treatment for Depressed Adolescents", - "phase": "", - "drugs": "['Cognitive Behavioral Therapy for Insomnia']", - "drugs_list": [ - "Cognitive Behavioral Therapy for Insomnia" - ], - "diseases": "['Insomnia', 'Depression']", - "diseases_list": [ - "Insomnia", - "Depression" - ], - "enrollment": "28.0", - "inclusion_criteria": "inclusion criteria: \n\n Between 13-19 years of age \n\n Are depressed \n\n Have insomnia \n\n ", - "exclusion_criteria": ": \n\n Are not depressed \n\n Do not have insomnia \n\n Currently using a sleep aid \n\n Have bipolar depression \n\n Have psychotic disorder \n\n Have a sleep disorder other than insomnia", - "brief_summary": "Major depressive disorder (MDD) occurs at least 11% of adolescents and approximately 53-90% of those adolescents have insomnia. If left untreated, insomnia increases the risk of relapse and recurrence of depressive episodes, unintentional injuries, poor school performance, substance use, obesity, and the risk for suicide. This project seeks to develop a nonpharmacological treatment for insomnia in adolescents with depression that is feasible and effective. The specific methodologies that will help accomplish these results are: 1) use of focus groups of adolescents with depression and insomnia to determine how the current standard, nonpharmacological treatment for insomnia (cognitive-behavioral therapy for insomnia; CBTI) among adults can be modified for use by adolescents with depression and 2) determine the preliminary effectiveness, feasibility, and tolerability of group CBTI in adolescents with depression (CBTI-AD) developed using feedback from the focus groups. This project will help to improve the quality and scope of delivery of mental health services in Michigan by a) gaining a greater understanding of how sleep disturbance may perpetuate depression in adolescents and b) to provide mental health professionals with a nonpharmacological treatment option for insomnia in adolescents with depression.", - "NCTID": "NCT02163564" - }, - { - "brief_title": "Adapted and Translated, Adolescent Depression, Internet Intervention", - "phase": "", - "drugs": "['Intervention group']", - "drugs_list": [ - "Intervention group" - ], - "diseases": "['Adolescent - Emotional Problem']", - "diseases_list": [ - "Adolescent - Emotional Problem" - ], - "enrollment": "138.0", - "inclusion_criteria": "inclusion criteria: \n\n age 13 to 21 \n\n experience a moderately elevated level of depressive symptoms on the CES-D scale (score 16-34) \n\n may or may not have had a past history of depression, anxiety and/or substance abuse \n\n ", - "exclusion_criteria": ": \n\n currently diagnosed with depression, schizophrenia, or bipolar affective disorder ; \n\n currently taking antidepressants or psychotropic medication ; \n\n CES-D score equal or higher than 35, or a proved serious medical illness that causes significant disability or dysfunction ; \n\n exhibit significant reading impairment, mental retardation, developmental disabilities \n\n serious imminent suicidal risk or other conditions that may require immediate psychiatric hospitalization \n\n have extreme, current drug / alcohol abuse (greater than or equal to 2 on the CRAFFT)", - "brief_summary": "Objectives :~The key objective of this study is to develop new interventions that addresses the diverse needs and circumstances of Hong Kong adolescents with depressive symptoms in community settings. Collaboration between medical professionals and social workers may prevent the occurrence of depression and misguided attempts to self-treat with alcohol and / or drugs in our adolescents.~Methods :~To address this intervention gap in the United States, Dr. Van Voorhees, a research collaborator of Dr. Chim and Dr. Ip, developed and conducted a phase 2 clinical trial of a primary care internet-based depression prevention intervention (CATCH-IT, Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal training). It has been observed clinically that the strategy could reduce depressed mood, increased social support and reduced depressive episodes at 12 month follow-up.~The investigators now propose to study if an adaptation of the CATCH-IT website for Hong Kong Chinese adolescents may lead to significant reductions in depressed mood. In this pilot trial, the investigators propose to test the efficacy of the Adapted and Translated version of CATCH-IT (AT-CATCH) against the placebo approach in preventing the onset of depressive episodes in a group of adolescents (aged 13-17) who have depressive symptoms, but have not developed depression yet.The case group will have access to the AT-CATCH website while the control group will only be allow to use the anti-smoking website.~The investigators hypothesize that compared to youth in the control group, youth assigned to the AT-CATCH group will have a lower hazard ratio of major depressive episodes and decreased alcohol / drug use frequency over 2 years. Moreover, compared to youth in the control group, youth in the AT-CATCH program will demonstrate a steeper slope of improved symptoms through growth curve analysis and fewer depressed days over the study period.", - "NCTID": "NCT01783652" - }, - { - "brief_title": "Lamotrigine in the Treatment of Binge Eating Disorder Associated With Obesity", - "phase": "Phase 3", - "drugs": "['Lamotrigine', 'placebo']", - "drugs_list": [ - "Lamotrigine", - "placebo" - ], - "diseases": "['Binge Eating Disorder', 'Obesity']", - "diseases_list": [ - "Binge Eating Disorder", - "Obesity" - ], - "enrollment": "70.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients will meet DSM-IV-TR criteria for BED for at least the last 6 months, determined by the Structured Clinical Interview for DSM-IV-TR (SCID) (61) and supported by the Eating Disorder Examination (EDE) (62). These criteria are as follows: \n\n Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following: \n\n eating, in discrete period of time (e.g., within any two hour period), an amount of food that is definitely larger than most people would eat in a similar period of time under similar circumstances \n\n a sense of lack of control over eating during the episode (e.g., a feeling that one cannot stop eating or control what or how much one is eating) \n\n The binge eating episodes are associated with at least three of the following: \n\n eating much more rapidly than normal \n\n eating until uncomfortably full \n\n eating large amounts of food when not feeling physically hungry \n\n eating alone because of being embarrassed by how much one is eating \n\n feeling disgusted with oneself, depressed, or feeling very guilty after overeating \n\n Marked distress regarding binge eating. \n\n The binge eating occurs, on average, at least two days a week for six months. \n\n Does not occur exclusively during the course of bulimia nervosa and anorexia nervosa. \n\n Obesity, defined by body mass index > 30 kg/m2. \n\n Men or women, between the ages of 18 and 65. \n\n ", - "exclusion_criteria": ": \n\n Have current body mass index < 30 kg/m2. \n\n Women who are pregnant or lactating and women of childbearing potential who are not taking adequate contraceptive measures. (All women of childbearing potential will have a negative pregnancy test before entering the study.) \n\n Subjects who are displaying clinically significant suicidality or homicidality. \n\n Subjects who are displaying a current clinically unstable depressive or bipolar disorder, defined as a Montgomery Asberg Depression Rating Scale (MADRS) (63) > 24 or a Young Mania Rating Scale (YMRS) (64) > 8. \n\n A current or recent (within 6 months of the start of study medication) DSM-IV-TR diagnosis of substance abuse or dependence. \n\n A lifetime history of a DSM-IV-TR psychotic disorder or dementia. \n\n History of a personality disorder (e.g., schizotypal, borderline, or antisocial) which might interfere with assessment or compliance with study procedures. \n\n Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease which could interfere with diagnosis, assessment, or treatment of binge eating disorder. Patients should be biochemically euthyroid prior to entering the study. \n\n History of seizures, including febrile seizures in childhood. \n\n Subjects requiring treatment with any drug which might interact adversely with or obscure the action of the study medication (e.g., stimulants, sympathomimetics, antidepressants, carbonic anhydrase inhibitors, anti-obesity drugs). \n\n Subjects who have received psychoactive medication (other than zaleplon [Sonata] or zolpidem [Ambien] -- as needed for restlessness/insomnia) within one week prior to randomization. \n\n Subjects who have begun and/or are receiving formal psychotherapy (cognitive behavioral therapy, interpersonal therapy, or dietary behavioral therapy) for BED or weight loss within the past 3 months. \n\n Subjects previously enrolled in this study or have previously been treated with lamotrigine. \n\n Subjects who have received an experimental drug or used an experimental device within 30 days.", - "brief_summary": "This research study is to evaluate the effectiveness, tolerability, and safety of lamotrigine therapy in the treatment of binge eating disorder associated with obesity.~Lamotrigine has been approved by the Food and Drug Administration for the treatment of bipolar disorder, but has not been approved for use in the treatment of binge eating disorder with obesity.", - "NCTID": "NCT00277641" - }, - { - "brief_title": "Zonisamide for Weight Reduction in Obese Adults", - "phase": "", - "drugs": "['Zonisamide']", - "drugs_list": [ - "Zonisamide" - ], - "diseases": "['Obesity']", - "diseases_list": [ - "Obesity" - ], - "enrollment": "225.0", - "inclusion_criteria": "inclusion criteria: Age 18-65 years; BMI 30-50 \n\n ", - "exclusion_criteria": ": \n\n Secondary obesity; Significant cardiovascular disease; Stroke, seizure disorder or other significant neurological disease; Significant liver or gallbladder disease; Significant renal disease or history of kidney stones; HIV positive status; Diabetes mellitus; Untreated or unstable hypothyroidism Malignancy in the past 5 years; Concomitant medications that cause significant weight gain or weight loss; Concomitant use of prescription or OTC weight loss medications; Had bariatric surgery or planning surgery in the next 1 year; Weight change of more than 4 kg in the past 3 months; Suicidal subjects; Major depression in the past 6 months; History of psychosis, bipolar disorder, or severe personality disorders; Subjects taking antipsychotics or mood stabilisers; Alcohol or substance abuse in the past 6 months; Currently taking zonisamide or other antiepileptic drugs; History of hypersensitivity to zonisamide or sulfonamides; Pregnant or planning pregnancy in the next year, or breastfeeding; Severe physical disability; Current participation in a commercial weight loss program or planning to participate; Currently following low-carbohydrate, high protein, high fat diet; Use of investigational medications or devices (current or past 4 weeks) \n\n -", - "brief_summary": "The primary aim of this study is to assess long-term weight loss efficacy of zonisamide relative to placebo in obese patients prescribed a dietary intervention.", - "NCTID": "NCT00275834" - }, - { - "brief_title": "Lithium Versus Paroxetine in Major Depression", - "phase": "Phase 4", - "drugs": "['Lithium', 'Paroxetine']", - "drugs_list": [ - "Lithium", - "Paroxetine" - ], - "diseases": "['Major Depressive Disorder']", - "diseases_list": [ - "Major Depressive Disorder" - ], - "enrollment": "2.0", - "inclusion_criteria": "inclusion criteria: \n\n men or women \n\n age of 18 years or older \n\n meet criteria for major depressive episode, and have a family history of bipolar disorder or completed suicide \n\n ", - "exclusion_criteria": ": \n\n subjects not able to give informed consent \n\n pregnant or breast-feeding women \n\n current panic disorder, post traumatic stress disorder or psychosis \n\n subjects with a history of mania or hypomania \n\n subjects with active substance abuse or dependence in the last 6 months \n\n current depressive episode less than 4 weeks or greater than 12 months in duration \n\n adequate trial of lithium or paroxetine (lithium level \u2265 0.6mmols/l; paroxetine 20mgs \u2265 5 weeks) for this episode of depression \n\n concurrent use of other antidepressants or augmenting agents for the treatment of depression \n\n clinically significant medical illness, in particular renal impairment", - "brief_summary": "This study is being done to look at how well people respond to two different drug treatments for depression. Clinically, people can respond differently to different treatments for reasons which are not always clear. Some research shows that people with a family history of bipolar disorder or completed suicide may react differently to standard medications used to treat depression than those without a family history. The investigators need to know if these drugs are effective to use in patients with depression who have a family history of bipolar disorder or completed suicide.", - "NCTID": "NCT01416220" - }, - { - "brief_title": "Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation", - "phase": "Phase 4", - "drugs": "['paliperidone', 'lithium', 'Placebo']", - "drugs_list": [ - "paliperidone", - "lithium", - "Placebo" - ], - "diseases": "['Major Depressive Disorder', 'Suicidal Ideation']", - "diseases_list": [ - "Major Depressive Disorder", - "Suicidal Ideation" - ], - "enrollment": "54.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female subjects who are able to provide informed consent \n\n 19-65 years of age \n\n Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of MDD by MINI International Neuropsychiatric Interview (MINI) and confirmed by psychiatric interview \n\n Currently experiencing a depressive episode with suicidality (defined as having current suicidal thoughts occurring at least 3 out of 7 days in a week). \n\n Montgomery-Asberg Depression Rating Scale (MADRS) must include a total score > 25 and a suicidal sub-score > 4. \n\n ", - "exclusion_criteria": ": \n\n Depressed patients without suicidality, patients with severe psychotic features or with primary diagnoses of bipolar disorder (BD), schizophrenia, schizoaffective disorder, or generalized anxiety disorder (GAD), and subjects who have been taking lithium or an antipsychotic in the past 2 weeks \n\n Those with uncontrolled medical illnesses. Participants must be on any new medications for at least 30 days to be considered medically stable. \n\n For patients with panic disorder, post-traumatic stress disorder (PTSD), borderline personality disorder (BPD), etc. be sure that MDD is the primary diagnosis. When in doubt, decisions will be made on a case-by-case basis. \n\n Pregnant women. \n\n Allergic to paliperidone, to any other ingredient in paliperidone ER or paliperidone palmitate, or to risperidone.", - "brief_summary": "The study aims to use a combined clinical and translational approach to identify an efficient pharmacotherapy for the acute management of suicidality and the epigenetic regulation associated with the treatment.The primary objective is a clinical trial to compare the efficacy of paliperidone versus lithium and placebo as adjunctive therapy to the standard of care antidepressants in the acute management of suicidality in depressed subjects.~Specific Aims 1 and 2 are described in detail below. Analysis for Specific Aim 2 is still underway.", - "NCTID": "NCT01134731" - }, - { - "brief_title": "Study of Varenicline (Champix) for Smoking Cessation/Reduction in Patients With Bipolar Disorder", - "phase": "", - "drugs": "['varenicline']", - "drugs_list": [ - "varenicline" - ], - "diseases": "['Nicotine Dependence']", - "diseases_list": [ - "Nicotine Dependence" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Structured Clinical Interview (SCID) derived DSM-IV diagnoses of Bipolar Disorder (Type I or II), and Nicotine Dependence \n\n Young Mania Rating Scale Total Score <12 at study entry \n\n HAM-D 17-Item Score >5 and <24 at study entry \n\n Fagerstrom Test for Nicotine Dependence (FTND) score of 5 or higher \n\n Be able to provide informed consent to participate in this study as judged by clinical evaluation, and scoring at least 80% on a post-consent test \n\n Smoking at least 10 cigarettes per day (confirmed by an expired breath CO level >10 ppm and a plasma cotinine level >150 ng/ml at baseline) \n\n Be motivated to quit smoking within 30 days of initial evaluation, as assessed by a score of 7 or higher on the Contemplation Ladder assessment tool \n\n On a stable dose of a mood stabilizer for at least 1 month (e.g. lithium, valproate, carbamazepine, atypical antipsychotic) \n\n Judged by the study psychiatrists and/or trained psychiatric clinicians to be in remission from active manic, hypomanic, major depressive and psychotic symptoms based on a clinical interview and SCID-IV \u22651 month prior to study enrollment \n\n ", - "exclusion_criteria": ": \n\n Meet criteria for current abuse or dependence for any other alcohol or illicit substance within the past 3 months of study enrollment \n\n Current evidence by SCID-IV and clinical evaluation of suicidality, homicidality or psychosis \n\n Meet DSM-IV criteria for current major depression at the time of baseline evaluation \n\n A history of hypersensitivity or other known adverse reactions (e.g. hyperstimulation, severe agitation) to varenicline. \n\n Serious medical conditions (i.e. a history of severe cardiac, renal or hepatic disease, diabetes mellitus or thyroid abnormalities) \n\n EKG abnormalities \n\n Prescription of Nicotine Replacement Therapies (NRTs) including patches, gum, lozenges or inhalers \n\n Prescription of monoamine oxidase inhibitors (MAO-I's) including selegiline or moclobemide \n\n Prescription of varenicline \n\n Prescription of bupropion SR \n\n The presence of manic, mixed manic or hypomanic symptoms in the past one month prior to study enrollment. \n\n A lifetime history of antidepressant-induced mania or hypomania \n\n A history of suicidal ideation while taking antidepressants", - "brief_summary": "Bipolar Disorder is a chronic relapsing mental disorder characterized by periods of elevated, expansive and irritable mood, often alternating with periods of significant clinical depression. People with Bipolar Disorder are typically heavy smokers who have difficulty quitting, and this is associated with significant tobacco-related medical illness and death.~The proposed study will be a double-blind, placebo-controlled 10-week clinical trial of the safety and efficacy of varenicline (Champix\u2122) in thirty subjects with Bipolar I Disorder. This medication is the latest first-line pharmacotherapy for smoking cessation and has been shown to be efficacious for smoking cessation, but has not yet been systematically studied in persons with Bipolar Disorder.", - "NCTID": "NCT01093937" - }, - { - "brief_title": "Zolpidem Postmarketing Study in Adolescent Patients With Insomnia", - "phase": "Phase 4", - "drugs": "['Zolpidem (Myslee\u00ae)', 'placebo']", - "drugs_list": [ - "Zolpidem (Myslee\u00ae)", - "placebo" - ], - "diseases": "['Insomnia']", - "diseases_list": [ - "Insomnia" - ], - "enrollment": "122.0", - "inclusion_criteria": "inclusion criteria: \n\n patients diagnosed as having nonorganic insomnia of nonorganic sleep disorder in ICD10 \n\n patients whose age at the time of obtaining consent is 12 years or over and 18 years or below \n\n ", - "exclusion_criteria": ": \n\n patients with schizophrenia or manic-depressive illness \n\n patients with insomnia caused by physical diseases \n\n patients having a history of hypersensitivity to zolpidem \n\n patients with attention-deficit hyperactivity disorder", - "brief_summary": "To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized double blind-controlled trial", - "NCTID": "NCT00432198" - }, - { - "brief_title": "Aripiprazole in Children and Adolescents With Bipolar Disorder and Attention Deficit Hyperactivity Disorder (ADHD)", - "phase": "", - "drugs": "['Aripiprazole']", - "drugs_list": [ - "Aripiprazole" - ], - "diseases": "['Bipolar Disorder', 'Attention Deficit Hyperactivity Disorder']", - "diseases_list": [ - "Bipolar Disorder", - "Attention Deficit Hyperactivity Disorder" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Age: 8-17 \n\n BD type I or II comorbid with ADHD \n\n Baseline score in the YMRS > or = 20 \n\n ", - "exclusion_criteria": ": \n\n IQ < 70 \n\n Pharmacologic treatment in the last month \n\n Pregnancy or absence of a contraceptive method in fertile girls \n\n Diagnoses: pervasive development disorder, schizophrenia, drug abuse or dependency \n\n Risk of suicide or homicide \n\n Clinical condition that might interfere in the study \n\n Known sensibility to aripiprazole", - "brief_summary": "There is a scarcity of clinical trials assessing the effects of medications in children with bipolar disorder. This study aims to assess the efficacy of Aripiprazole (a novel anti-psychotic drug) for the treatment of children and adolescents with bipolar disorder comorbid with ADHD. The study design is a 8-week randomized, double blind, parallel group trial. Patients were randomized to either aripiprazole or placebo.~The main hypotheses are:~Aripiprazole will significantly reduce maniac scores compared to placebo~Aripiprazole will significantly reduce ADHD scores compared to placebo", - "NCTID": "NCT00116259" - }, - { - "brief_title": "Two Contrasting Interventions for Sleep Management", - "phase": "Phase 2; Phase 3", - "drugs": "['Zolpidem', 'Mind-Body Bridging']", - "drugs_list": [ - "Zolpidem", - "Mind-Body Bridging" - ], - "diseases": "['Primary Insomnia', 'Secondary Insomnia']", - "diseases_list": [ - "Primary Insomnia", - "Secondary Insomnia" - ], - "enrollment": "72.0", - "inclusion_criteria": "inclusion criteria: \n\n primary insomnia \n\n secondary insomnia \n\n requiring sleep medication (Zolpidem) for a three-week trial. \n\n active duty military service member stationed at Fort Carson. \n\n ", - "exclusion_criteria": ": \n\n secondary insomnia to a likely medical condition, such as sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, and other sleep disorders, which are not appropriately treatable with sleep medication. \n\n treated for sleep problems using sleep medications which include Lunesta, Ambien, Ambien Controlled Release (CR), Seroquel, Trazodone or Remeron \n\n major psychopathology (i.e., schizophrenia) \n\n severe depression within the past 90 days \n\n suicidal ideation within the past 90 days \n\n psychiatrically hospitalized within the past 90 days \n\n uncontrolled hypertension or diabetes \n\n pregnancy \n\n previous use of Zolpidem proved to be ineffective or to cause other unwanted side effects \n\n actively abusing controlled substances \n\n enrolled in another study", - "brief_summary": "This study will determine whether Mind-Body Bridging (MBB), a mindfulness training program is more effective than a common sleep medication, Zolpidem, in treating insomnia. It will also investigate whether MBB is additionally beneficial for co-morbid conditions such as stress, PTSD, depression, etc, compared with that of Zolpidem.", - "NCTID": "NCT01804036" - }, - { - "brief_title": "Neuropsychological Characterization of Patients With Bipolar Disorder and a History of Suicide Attempt", - "phase": "", - "drugs": "['Interview', 'Neuropsychological testing', 'Serum concentration of lithium or sodium divalproate.']", - "drugs_list": [ - "Interview", - "Neuropsychological testing", - "Serum concentration of lithium or sodium divalproate." - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n The patient was correctly informed about the study \n\n The patient must be insured or beneficiary of a health insurance plan \n\n The diagnosis of bipolar disorder is confirmed by the doctor referring the patient to the BEC and confirmed during the preliminary interview at the BEC \n\n The patient is euthymic on the day of inclusion. This is supported by a short psychiatric interview conducted at the BEC and the completion of the depression and mania scales (score <= 7 on the HDRS questionnaire and score <= 7 on the YMRS questionnaire). \n\n The patient is prescribed a mood stabilizer based on lithium or divalproex. \n\n ", - "exclusion_criteria": ": \n\n The patient is under judicial protection, under tutorship or curatorship \n\n The patient formalizes his/her opposition to the studyd \n\n It is impossible to correctly inform the patient \n\n The patient has mental retardation \n\n The patient has practiced substance abuse or dependence within the 6 months prior to study inclusion (alcool, cannabis, opiates, psychostimulants) \n\n The patient does not meet euthymic criteria (score <= 7 on the HDRS questionnaire and score <= 7 on the YMRS questionnaire). \n\n Uninclusion criteria: \n\n The patients withdraws consent during the study \n\n The patient does not understand directions necessary for the neurpsychological tasks \n\n The patient is not able to use a computer to complete the neuropsychological tasks", - "brief_summary": "The main objective of this study is to evaluate decision-making using the Iowa Gambling Task (IGT) among patients with euthymic bipolar disorder according to their personal history of suicide attempt (suicidal vs. not suicidal ).", - "NCTID": "NCT02116400" - }, - { - "brief_title": "The Assessment of a Weight-Gain Agent for the Treatment of Olanzapine-Associated Anti-Obesity Agent in Patients With Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, and Bipolar I Disorder", - "phase": "Phase 4", - "drugs": "['Sibutramine']", - "drugs_list": [ - "Sibutramine" - ], - "diseases": "['Schizophrenia', 'Psychotic Disorders', 'Bipolar Disorder']", - "diseases_list": [ - "Schizophrenia", - "Psychotic Disorders", - "Bipolar Disorder" - ], - "enrollment": "130.0", - "inclusion_criteria": "Eligibility Criteria: \n\n You must be between the ages of 18 and 65. If you have reached your 66th birthday, you will not be able to participate. \n\n You must have been diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, or bipolar I disorder and be taking olanzapine. \n\n You must be able to visit the doctor's office as scheduled for the next 4 months. \n\n ", - "exclusion_criteria": ": \n\n You have a history of an illness that would cause weight loss or gain in the near future. \n\n You have taken remoxipride within the past 6 months. \n\n You are allergic to olanzapine or Anti-obesity Agent. \n\n You have uncontrolled high blood pressure, congestive heart failure, or have had a stroke. \n\n You have a serious medical illness, such as heart, liver, or kidney disease. \n\n You are pregnant or breast feeding.", - "brief_summary": "Olanzapine is currently marketed for the treatment of schizophrenia and acute manic episodes with bipolar 1 disorder. This Anti-obesity Agent is currently marketed for the management of obesity. In this study, the Anti-obesity Agent is being tested to see if it can treat weight gain that may be associated with taking olanzapine.~The purposes of this study are to determine the safety of olanzapine when given in combination with the Anti-obesity Agent and any side effects that might be associated with it and whether weight-gain agent can help treat weight gain that may be associated with taking olanzapine.", - "NCTID": "NCT00044187" - }, - { - "brief_title": "Ambien CR vs. Placebo For Treatment Of Insomnia Associated With Anxiety When Used Concomitantly With Escitalopram (Lexapro)", - "phase": "Phase 4", - "drugs": "['zolpidem tartrate']", - "drugs_list": [ - "zolpidem tartrate" - ], - "diseases": "['Insomnia']", - "diseases_list": [ - "Insomnia" - ], - "enrollment": "372.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female between the ages of 21and 64 years, inclusive; \n\n Women must use a medically acceptable form of contraception during the entire study period, or: be surgically sterilized, post-menopausal, agree to use double-barrier contraception throughout the study period, or must have a negative urine pregnancy test prior to randomization; \n\n Must meet the diagnostic requirements of Generalized Anxiety Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders; \n\n Score at least 18 on the Hamilton Rating Scale for Anxiety (HAM-A) \n\n Must be either newly diagnosed or show symptoms of relapse during a period of no drug therapy for anxiety. \n\n Subject must experience sleep disturbances at least three nights per week, for at least one month prior to study entry, based on historical data. \n\n Subject must be stabilized on all long-term medication therapy for at least one month prior to study entry. \n\n EXCLUSION \n\n History of Post-Traumatic Stress Disorder; \n\n Concomitant Major Depressive Disorder or Bipolar Disorder; \n\n Any abnormal pre-study laboratory values that require clinical intervention \n\n Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous month. \n\n Pregnant or breastfeeding \n\n History of drug addiction, alcoholism, or drug abuse \n\n Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization. \n\n A positive urine drug screen for compounds that would interfere with the assessment of a hypnotic. \n\n Use of prescription and non-prescription sedative drugs; \n\n Prior failure to respond to escitalopram therapy for anxiety \n\n The presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebrovascular disease or malignancy. \n\n History of sleep apnea \n\n History of myasthenia gravis \n\n Known hypersensitivity and/or allergy to or previous adverse experience with zolpidem or escitalopram or any of their excipients \n\n Subject is currently participating in another clinical trial (or within 28 days of screening).", - "exclusion_criteria": "", - "brief_summary": "A comparison of Zolpidem Tartrate Extended-Release (Ambien CR)vs. Placebo in the Treatment of Insomnia Associated with Generalized Anxiety Disorder (GAD) when Used Concomitantly with Escitalopram (Lexapro - antidepressant).", - "NCTID": "NCT00296790" - }, - { - "brief_title": "Reducing Weight Gain and Improving Metabolic Function in Children Being Treated With Antipsychotics", - "phase": "Phase 4", - "drugs": "['Aripiprazole or Perphenazine', 'Metformin', 'Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine']", - "drugs_list": [ - "Aripiprazole or Perphenazine", - "Metformin", - "Olanzapine", - "quetiapine", - "risperidone", - "ziprasidone", - "aripiprazole", - "asenapine", - "iloperidone", - "lurasidone", - "paliperidone", - "or olanzapine/fluoxetine" - ], - "diseases": "['Psychotic Disorders']", - "diseases_list": [ - "Psychotic Disorders" - ], - "enrollment": "127.0", - "inclusion_criteria": "inclusion criteria: \n\n DSM diagnoses that have an FDA indication for atypical antipsychotic use for at least one agent in the respective pediatric or adult age group. Specifically, primary DSM-IV diagnosis of Early Onset Schizophrenia Spectrum (EOSS; schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder NOS); Bipolar Spectrum (bipolar I, II and NOS); Major depressive disorder with psychosis; Mood disorder NOS corresponding to Leibenluft and colleagues severely mood dysregulated (SMD) broad spectrum bipolar disorder; Mood disorder NOS corresponding to irritability associated with autism spectrum disorders; or - for adult teen participants aged 18-19 years - Major depressive disorder. Diagnoses will be determined by clinical interview, Leibenluft's modification of the K-SADS-PL, and the Aberrant Behavior Checklist (cutoff score of 18, as used by FDA for approval of risperidone and aripiprazole in minors). \n\n Clinically stable on current treatment regimen for at least 30 days, as assessed in a three-step process \n\n Current SGA treatment with olanzapine, quetiapine, risperidone, ziprasidone aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine for \u2265 8 weeks \n\n Stable dose of current SGA and psychotropic co-medications for at least 30 days \n\n Body mass index (BMI) at least in the 85th percentile for age and gender \n\n Substantial weight gain over the previous 3 years while taking a SGA, as reflected by family and referring physician's judgment. The weight gain did not have to occur on the child's current SGA. Weight needs to have remained stable or increased over past year. \n\n Agrees to use two effective forms of birth control or to remain abstinent \n\n Has a primary caretaker who has known the child well for at least 6 months before study entry \n\n Primary caretaker is able to participate in study appointments as clinically indicated \n\n ", - "exclusion_criteria": ": \n\n Treatment with any medication (other than the currently prescribed psychotropic medications) that would significantly alter glucose, insulin, or lipid levels. Exception: orlistat and amantadine are permitted if the individual has taken the drug for at least one year without weight loss. \n\n Major neurological or medical illness that affects weight gain or that would prevent participation in physical activities \n\n Fasting glucose levels indicating need for prompt treatment \n\n Pediatrician or pediatric gastroenterologist recommendation to address abnormal fasting labs by pursuing more active treatment than those in the 2007 American Medical Association guidelines \n\n Diagnosis of anorexia nervosa or bulimia nervosa, as based on current or lifetime DSM-IV criteria \n\n Diagnosis of substance dependence disorder (other than tobacco dependence) within the past month, as based on DSM-IV criteria \n\n Positive urine toxicology indicating ongoing use of illicit substance \n\n Current treatment with more than one antipsychotic medication \n\n Current treatment with more than 3 total psychotropic medications (i.e., 2 psychotropics plus SGA), with the exception of subjects taking 2 medications for ADHD in which a total of 4 psychotropic medications are allowed. \n\n Known hypersensitivity to metformin \n\n Prior treatment with aripiprazole and perphenazine for more than 2 weeks that was stopped for inefficacy or intolerability \n\n Pregnant, breastfeeding, or unwilling to comply with contraceptive requirements of study \n\n IQ score less than 55 \n\n Significant risk of dangerousness to self or to others that would make study participation inadvisable \n\n Language issues that prevent child and/or parent from completing assessments or treatment \n\n Ongoing or previously undisclosed child abuse requiring new department of social service intervention", - "brief_summary": "This study will test the effectiveness of two different treatments for children and adolescents who have gained weight on their antipsychotic medications.", - "NCTID": "NCT00806234" - }, - { - "brief_title": "Comparison of Combination Olanzapine+Lithium or Chlorpromazine+Lithium in Treatment of First Manic Episode With Psychotic Features", - "phase": "Phase 4", - "drugs": "['Olanzapine', 'Lithium', 'Chlorpromazine']", - "drugs_list": [ - "Olanzapine", - "Lithium", - "Chlorpromazine" - ], - "diseases": "['Bipolar Disorder', 'Schizoaffective Disorder']", - "diseases_list": [ - "Bipolar Disorder", - "Schizoaffective Disorder" - ], - "enrollment": "83.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female patients aged 15 to 29. \n\n Experiencing a first episode psychosis. \n\n Meet DSM-IV criteria for bipolar either manic or mixed episode, or schizoaffective disorder manic episode. \n\n Minimum score of 20 on the YMRS \n\n Written informed consent to participation. \n\n ", - "exclusion_criteria": ": \n\n Patients at immediate risk of committing harm to self or others \n\n Use of neuroleptics or mood-stabilisers in the two months preceding admission to EPPIC \n\n Organic mental disease, including mental retardation \n\n History of clinically significant illness (liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological or metabolic disturbances). \n\n Clinically relevant biochemical or hematological abnormalities. \n\n Pregnant or lactating woman \n\n History of epilepsy \n\n History of severe drug allergy or hypersensitivity \n\n Non fluency in English.", - "brief_summary": "Aim: In a population of first episode manic patients with psychotic features, we want to compare the side effect profile, the degree of adherence and the subjective well being, as well as the efficacy of two treatments: The standard treatment currently applied (lithium + chlorpromazine) and an alternative treatment more recently introduced (lithium + olanzapine). In addition, we want to study retrospectively the development of bipolar disorder and study prospectively the 6 and 12-month outcome of a cohort of patients presenting a first manic episode with psychotic features.~Research Background: While the efficacy of lithium in the treatment of acute mania has been established by numerous studies, it is also known that up to 50% of the patients fail to respond when it is prescribed alone. It is therefore common practice to complement the treatment, most commonly with antipsychotics and benzodiazepines. It has been suggested that antipsychotic agents are faster acting and are superior in controlling hyperactivity compared to lithium, whereas mood stabilisation is better achieved by lithium, Typical antipsychotics, such as chlorpromazine, may therefore be useful as adjunctive medication to mood stabilisers, especially within the first few weeks of treatment of acute mania, and for patients exhibiting psychotic symptoms or hyperactivity. They however can induce side effects (somnolence, dizziness, dry mouth, extrapyramidal side effects such as rigidity of the muscles, and possibly tardive dyskinesia (involuntary movements or contraction of muscles), as well as akathysia (sense of restlessness). They finally have been suspected to contribute to the occurrence of post-manic depression. Recent publications in chronic populations have shown that atypical antipsychotics, such as olanzapine, are also an effective adjunctive treatment. Olanzapine has the important advantage to induce a very low incidence of extrapyramidal side effects, including tardive dyskinesia. It can however induce somnolence, dizziness, dry mouth, and rather commonly weight gain. Moreover, some authors have reported that olanzapine might induce mania. Both treatments appear then to have positive effects as well as undesirable side effects. Our project is to compare them. The literature concerning first episode mania is sparse, particularly in the domain of pharmacotherapy. One retrospective study showed that 77% of the patients received antipsychotics at discharge and 25% at 6 months follow-up. No comparison has however been made between typical and atypical antipsychotics, and there are no specific treatment guidelines of first episode mania with psychotic features.~Project Summary: The hypothesis is that olanzapine and chlorpromazine will have a comparable efficacy as adjunctive treatment of the acute manic episode with psychotic features. We however think olanzapine will induce less side effects and will be better accepted by the patients, and therefore that the adherence to the treatment will be better than with chlorpromazine. We finally think the subjective sense of well being will be greater with olanzapine than with chlorpromazine.We will recruit 75 patients at the time of their first admission for mania with psychotic features at EPPIC. After signature of the informed consent, we will perform a baseline assessment first to confirm the diagnosis, and second to evaluate the level of psychopathology. The patients will then be randomly selected to receive either a treatment of lithium and olanzapine or a treatment of lithium and chlorpromazine. By the end of the study there will be 37 patients in each group.The patients will go through a baseline assessment including physical examination and usual laboratory investigation to exclude any physical illness. They will also go through a one-hour assessment of psychopathology. Between day 2 and 3 they will go through 2 hours of interview to reassess diagnosis and personal history. They will thereafter be assessed weekly for eight weeks on various dimensions: evolution of the intensity of the symptoms, appearance of depressive symptoms, occurrence of side effects and degree of adherence to the treatment, in an 1-hour interview. Subjective well being and quality of life will re evaluated at week 4 and 8, adding 45 minutes to the duration of the interview. This is a flexible dose, open trial, which means the doctor in charge of the patient will know which medication is being prescribed, and that he will be allowed to adapt the dosage according to what he feels necessary. This research project will allow us to organise a more specialised clinic for the care of first episode manic patients. We will take this opportunity to study carefully the months preceding the appearance of the first episode in order to try to reconstruct the prodrome of bipolar disorders. We will also, in an extension phase of the study, look at the long term outcome (at 6 and 12 months) of a first episode of mania.", - "NCTID": "NCT00202293" - }, - { - "brief_title": "Topiramate vs. Placebo in Preventing Weight Gain in Bipolar Disorder Treated With Olanzapine", - "phase": "Phase 4", - "drugs": "['Topiramate', 'Placebo']", - "drugs_list": [ - "Topiramate", - "Placebo" - ], - "diseases": "['Bipolar Disorder', 'Weight Gain']", - "diseases_list": [ - "Bipolar Disorder", - "Weight Gain" - ], - "enrollment": "31.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female patients, ages 10-18 years. \n\n Female patients of menarche must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence). \n\n Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation. \n\n Patients must have a diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) bipolar disorder, type I and currently display an acute manic or mixed episode as determined by K-SADS (Geller et al 2000). \n\n Patients must have a baseline (day 0) Young Mania Rating Scale score of at least 16. \n\n Subjects should be fluent in English. \n\n ", - "exclusion_criteria": ": \n\n Female patients who are either pregnant or lactating. \n\n Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions. \n\n Any history of current or past diabetes that has been treated with pharmacological intervention. \n\n Neurological disorders including epilepsy, stroke, or severe head trauma. \n\n Clinically significant laboratory abnormalities (> 3 times upper limit of normal), on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, or thyroid indices. Clinically abnormal ECG. \n\n Manic or mixed episode due to a general medical condition or substance-induced mania (DSM-IV-TR). \n\n Mental retardation (IQ <70). \n\n History of hypersensitivity to or intolerance of olanzapine or topiramate. \n\n Prior history of olanzapine or topiramate non-response or allergic reaction. \n\n DSM-IV substance (except nicotine or caffeine) dependence within the past 3 months. \n\n Judged clinically to be at suicidal risk (defined as having active suicidal ideation, intent or plan, or a serious suicide attempt within 30 days, or a baseline Children's Depression Rating Scale suicide score of >3). \n\n Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0. \n\n Treatment with concurrent mood stabilizers or anticonvulsants, benzodiazepines (except as described below), psychostimulants, guanethidine, or guanadrel, or antidepressants. \n\n Schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV. \n\n Major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified.", - "brief_summary": "The primary objective of this study is to examine the efficacy of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder. The secondary objective is to examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.", - "NCTID": "NCT00394095" - }, - { - "brief_title": "Psilocybin Cancer Anxiety Study", - "phase": "Phase 1", - "drugs": "['Psilocybin', 'Niacin']", - "drugs_list": [ - "Psilocybin", - "Niacin" - ], - "diseases": "['Cancer']", - "diseases_list": [ - "Cancer" - ], - "enrollment": "29.0", - "inclusion_criteria": "inclusion criteria: \n\n Age: 18-76 \n\n Current or historical diagnosis of cancer \n\n Projected life expectancy of at least one year \n\n DSM-IV diagnoses: Acute Stress Disorder, Generalized Anxiety Disorder, Anxiety Disorder due to cancer, Adjustment Disorder with anxious features \n\n Any stage of cancer diagnosis \n\n ", - "exclusion_criteria": ": \n\n Epilepsy \n\n Renal disease \n\n Diabetes \n\n Abnormal liver function \n\n Severe cardiovascular disease \n\n Malignant Hypertension \n\n Baseline blood pressure must be less than or equal to 140/90 \n\n Personal history or immediate family members with schizophrenia, bipolar affective disorder, delusional disorder, schizoaffective disorder or other psychotic spectrum illness \n\n Current substance use disorder \n\n Medication contraindications: anti-seizures medications, insulin, oral hypoglycemics, clonidine, aldomet, cardiovascular medications, anti-psychotics (first and second generation), anti-depressants and mood stabilizers", - "brief_summary": "The primary objective of this double-blind, placebo-controlled pilot study is to assess the efficacy of psilocybin administration (4-phosphoryloxy-N,N-dimethyltryptamine), a serotonergic psychoactive agent, on psychosocial distress, with the specific primary outcome variable being anxiety associated with cancer. Secondary outcome measures will look at the effect of psilocybin on symptoms of pain perception, depression, existential/psychospiritual distress, attitudes towards disease progression and death, quality of life, and spiritual/mystical states of consciousness. In addition, a secondary objective of the study is to determine the feasibility of administering psilocybin to this patient population, with regards to the following issues: safety, patient recruitment, consent for treatment, and retention. The duration of the proposed investigation will be long enough to administer the drug one time to each of thirty-two patients and to conduct follow-up assessments. This study is separate but similar to a recently completed study at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, run by a psychiatrist, Dr. Charles Grob. Although the outcomes measures would be similar to those used as in the Grob study, the proposed dose of psilocybin is higher at 0.3mg/kg and the total subjects for the study would be 32 instead of 12. The study utilizes a cross-over design at 7 weeks and includes prospective follow-up of 6 months duration. This study has been approved by the Bellevue Psychiatry Research Committee, the NYU Oncology PRMC Committee, the Food and Drug Administration (FDA) through the issuance of an IND (77,138), the New York University School of Medicine Institutional Review Board (NYU IRB), the Health and Hospitals Corporation (HHC)-New York University (NYU) Clinical Translational Science Institute (CTSI), the NYU Bluestone Center for Clinical Research, and the Drug Enforcement Agency (DEA) through the issuance of a schedule I license.~It is hypothesized that a one time experience with psilocybin will occasion dramatic shifts in consciousness and awareness that will lead to short-term (ie hours to days) and long-term (up to 6 months in this study, following the administration of the second dosing, either psilocybin or placebo) improvement in anxiety, depression, and pain associated with advanced cancer. The exact mechanism of action is unclear but based on studies done in the 60's using serotonergic hallucinogens in patients with advanced cancer, improvements in anxiety levels, mood and pain were reported. However, a treatment model developed by the famous British psychiatrist Humphrey Osmond, offers one possibility. In this model, serotonergic hallucinogens' therapeutic mechanism lies in their ability to allow the individual to access novel dimensions of consciousness and their efficacy or lack thereof relies on whether a transcendent and mystical state of awareness is attained. Another possible mechanism relates to what Dobkin de Rios and Grob have described as 'managed altered states of consciousness,' where the power of suggestibility, occurring in a safe setting, allows one to transcend a particular state of consciousness (i.e. anxiety and depression associated with advanced illness) as a means to facilitate emotional discharge and to manage irreconcilable conflict.", - "NCTID": "NCT00957359" - }, - { - "brief_title": "Efficacy, Safety, and Tolerability of Ambien (Zolpidem) in the Treatment of Children Ages 6 to 17 With Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia", - "phase": "Phase 3", - "drugs": "['Zolpidem (SL800750)']", - "drugs_list": [ - "Zolpidem (SL800750)" - ], - "diseases": "['Attention Deficit Hyperactivity Disorder']", - "diseases_list": [ - "Attention Deficit Hyperactivity Disorder" - ], - "enrollment": "201.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female between the ages of 6 and 17 years, inclusive \n\n Children with diagnosed ADHD (as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision [DSM-IV-TR] criteria) \n\n Complaint of childhood insomnia as defined by repeated difficulty with sleep initiation or consolidation that occurs despite adequate age, appropriate time, and opportunity for sleep \n\n The sleep disturbance must not be attributable to either the direct physiologic effect of drug abuse or misuse of a prescribed medication. \n\n Subjects should be stabilized on all long-term therapy, including treatment of ADHD, for at least one month prior to study entry. \n\n Subjects, if females of childbearing potential (as determined by the initiation of menses), must have confirmed negative pregnancy test prior to randomization and be using a recognized effective method of birth control (oral, implant, depot or transdermal oestroprogestatives, intrauterine device, double-barrier with spermicide). Abstinence is an acceptable method of birth control for this study. \n\n ", - "exclusion_criteria": ": \n\n Mental retardation \n\n Autistic spectrum disorder \n\n A history of sleep apnea \n\n A history of bipolar disorder, conduct disorder, major depression, or generalized anxiety disorder (not obsessive compulsive disorder), as determined by clinical interview and DSM-IV-TR criteria \n\n Current history of substance abuse/dependence \n\n Known hypersensitivity to zolpidem or previous adverse experience with zolpidem \n\n Pregnant or breast-feeding \n\n Current use of hypnotics, antihistamines, melatonin, herbal products, or other sleep aids", - "brief_summary": "There has been an increased interest in the association between ADHD and sleep disorders over the past years. A high incidence of sleep disturbance, ranging from 10% to 70%, has been identified in ADHD children regardless of whether or not they are receiving stimulant therapy. This study will assess the safety and efficacy of zolpidem in children with ADHD associated insomnia.", - "NCTID": "NCT00318448" - }, - { - "brief_title": "Phase IV to Evaluate the Safety of Self-administered ADASUVE\u00ae in Agitated Patients Outside the Hospital Setting", - "phase": "Phase 4", - "drugs": "['Staccato\u00ae Delivery System Loxapine (ADASUVE\u00ae)']", - "drugs_list": [ - "Staccato\u00ae Delivery System Loxapine (ADASUVE\u00ae)" - ], - "diseases": "['Agitation']", - "diseases_list": [ - "Agitation" - ], - "enrollment": "323.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female patients between the ages of 18-65 years, inclusive \n\n Patients (or legal representative) willing and able to provide written Informed Consent Form. \n\n Psychiatric patients already diagnosed of schizophrenia or bipolar disorder, according to the Diagnostic and Statistical Manual of Mental Disorders- IV, Diagnostic and Statistical Manual of Mental Disorders- V or International Code of Disease criteria. \n\n Patients with an on-going agitation episode, or with a previous one within the 6 months prior to screening, attended and managed in the hospital setting. \n\n Previously treated with ADASUVE\u00ae with a positive outcome (responders) according to (CGI-I) scale (defined as having a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation) \n\n Patients free of active respiratory disease such as acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (asthma, chronic obstructive pulmonary disease or emphysema). \n\n Requirement of family or other caregiver support at study investigator criteria (defined as a patient's relative or caregiver (male or female) \u2264 80 year old, who spend \u2265 3 consecutive hours with patient, with good physical and psychological health status and without physical limitations, reading and writing educational level and able to understand and follow the study procedures). \n\n Availability of patient's medical records data about the previous treatment with ADASUVE\u00ae at hospital setting. \n\n If a female is of childbearing potential and sexually active (except if female is surgically sterile or post-menopausal with history of no menses for at least 24 months), patient must be non-lactating and non-pregnant (with a negative pregnancy test result at baseline visit) and have to agree to use a medically acceptable and effective birth control method throughout the study and for one week following the end of the study. \n\n ", - "exclusion_criteria": ": \n\n Patient diagnosed with dementia. \n\n Patients with serious and unstable illnesses including current hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease and congestive heart failure), endocrinologic, neurologic (including stroke, transient ischemic attack, subarachnoidal bleeding, brain tumor, encephalopathy, and meningitis). \n\n Patients with a history of allergic reactions to loxapine or amoxapine \n\n Patients who have received an investigational drug within 30 days prior to the current agitation episode must be excluded. \n\n Patients who are considered by the investigator, for any reason, to be unable to self-administer the inhalation device.", - "brief_summary": "Phase IV, multinational, multicentre, open-label, non-randomized, clinical trial conducted in Europe (Spain, Germany, Finland, Norway, Romania and Austria) to evaluate the safety profile of ADASUVE\u00ae in agitated patients with schizophrenia or bipolar disorder when self-administered outside of a hospital setting without the supervision of a healthcare professional. The Study will aim to include approximately 500 patients who have been previously treated with ADASUVE\u00ae in the last 6 months prior to screening or recently treated during the planned recruitment period of 6 months with a 'positive outcome' ('ADASUVE\u00ae responder') according to Clinical Global Impressions (CGI-I) scale, from a total of about 30-34 centers. All patients will be followed up for a maximum of 6 months from baseline, during which it is expected that a new episode of agitation will occur.", - "NCTID": "NCT02525991" - }, - { - "brief_title": "Safety and Efficacy Study of Lithium for the Treatment of Pediatric Mania.", - "phase": "Phase 2; Phase 3", - "drugs": "['Lithium Carbonate', 'Placebo']", - "drugs_list": [ - "Lithium Carbonate", - "Placebo" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "81.0", - "inclusion_criteria": "inclusion criteria: \n\n Participants aged 7 years to 17 years, 11 months old at time of first dose \n\n Participants must meet DSM-IV diagnostic criteria, as assessed by a semi-structured assessment (KSADS-PL) and a separate clinical interview with a child/adolescent psychiatrist for manic or mixed episodes in bipolar I disorder \n\n Score of > 20 on the YMRS at screening and baseline \n\n The participant and legal guardian must understand the nature of the study and be able to comply with protocol requirements. The legal guardian must give written informed consent and the youth, written assent \n\n Participants with comorbid conditions [attention deficit hyperactivity disorder (ADHD), conduct disorder], except those listed in Exclusion Criterion 2, may participate \n\n If female: is premenarchal, or is incapable of pregnancy because of a hysterectomy, tubal ligation, or spousal/partner sterility. If sexually active and capable of pregnancy, has been using an acceptable method of contraception (hormonal contraceptives, intrauterine device, spermicide and barrier) for at least one month prior to study entry and agrees to continue to use one of these for the duration of the study. If sexually abstinent and capable of pregnancy, agrees to continued abstinence or to use of an acceptable method of birth control should sexual activity commence \n\n Has a negative quantitative serum \u00df-human chorionic gonadotrophin hormone pregnancy test at screening and a negative qualitative urine pregnancy test at baseline, if female \n\n Participants with a history of substance abuse may participate if they agree to continue to abstain from drugs during the trial and have a negative drug screen at screening or prior to baseline. Those with an initial positive drug screen during screening may have another screen done 1-3 weeks later while in screening, and a negative result will allow the participant to participate \n\n The participant is willing and clinically able to wash out of exclusion medications during the screening period. Prior to the administration of lithium, participants will have not used any of the following medications: antipsychotics, monoamine oxidase inhibitors, antidepressants within the preceding 2 weeks; stimulants within the preceding week; or fluoxetine or depot antipsychotics in the past month (no stable participants will be asked to discontinue medications) \n\n ECG and bloodwork including CBC, electrolytes, etc. (as per Safety assessment procedures listed in Table 6) showing no clinically significant abnormalities \n\n ", - "exclusion_criteria": ": \n\n Participant who is clinically stable on current medication regimen for bipolar disorder \n\n A current or lifetime diagnosis of Schizophrenia or Schizoaffective Disorder, a Pervasive Developmental Disorder (ASQ score > 15), Anorexia Nervosa, Bulimia Nervosa, or Obsessive-Compulsive Disorder \n\n Current DSM-IV diagnosis of Substance Dependence \n\n Positive drug screen at screening and on retest 1-3 weeks later \n\n Participants with symptoms of mania that may be attributable to a general medical condition, or secondary to use of medications (e.g., corticosteroids) \n\n Evidence of any serious, unstable neurological illness for which treatment under the auspices of this study would be contraindicated \n\n Any serious, unstable medical illness or clinically significant abnormal laboratory assessments that would adversely impact the scientific interpretability or unduly increase the risks of the protocol \n\n Current general medical condition including neurological disease, diabetes mellitus, thyroid dysfunction, or renal dysfunction that might be affected adversely by lithium, could influence the efficacy or safety of lithium, or would complicate interpretation of study results \n\n Evidence of current serious homicidal/suicidal ideation such that in the treating physician's opinion it would not be appropriately safe for the participant to participate in this study \n\n Evidence of current active hallucinations and delusions such that in the treating physician's opinion it would not be appropriately safe for the participant to participate in this study \n\n Concomitant prescription of over-the-counter medication or nutritional supplements (e.g., ibuprofen, naproxen, St John's wort) that would interact with lithium or affect the participant's physical or mental status \n\n Concomitant psychotherapy treatments provided outside the study initiated within 4 weeks prior to screening \n\n Previous adequate trial with Li+ (at least 4 weeks with Li+ serum levels between 0.8-1.2 mEq/L) \n\n History of allergy to lithium or lithium intolerance \n\n Psychiatric hospitalization within 1 month of screening for psychosis or serious homicidal/serious suicidal ideation \n\n Clinician's judgment that participant is not likely to be able to complete the study as an outpatient due to psychiatric reasons \n\n Females who are currently pregnant or lactating \n\n Sexually active females who, in the investigators' opinion, are not using an adequate form of birth control. \n\n Participants who are unable to swallow the study medication \n\n Participants for whom a baseline YMRS score of < 20 is anticipated \n\n Participants with an IQ less than 70 (determined using the Wechsler Abbreviated Scales of Intelligence {WASI} Vocabulary and Matrix Reasoning Subscales)", - "brief_summary": "Study Design This is the second study of a multiphase, multicenter trial that will comprehensively examine lithium in the treatment of pediatric participants with bipolar I disorder. In order to examine the treatment of bipolar disorder with lithium, this study will include four phases of treatment. The first phase, the Efficacy Phase, will include participants being randomized to either lithium or placebo for 8 weeks to determine the efficacy of lithium in the treatment of children and adolescents with bipolar I disorder. Once participants complete the Efficacy Phase, participants may be eligible to continue in the Long- Term Effectiveness Phase for a maximum of 24 weeks of lithium treatment. Subsequently, participants meeting response criteria during the Long-Term Effectiveness Phase will be eligible to continue in the Discontinuation Phase. During the Discontinuation Phase, participants will be randomized to either placebo or lithium treatment for up to 28 weeks. Finally, those participants who experience a mood relapse during the Discontinuation Phase will be enrolled in an Open Label Restabilization Phase and treated with lithium for up to 8 weeks.", - "NCTID": "NCT01166425" - }, - { - "brief_title": "Weight Gain Prevention", - "phase": "", - "drugs": "['large changes in eating and activity', 'small changes in eating and activity']", - "drugs_list": [ - "large changes in eating and activity", - "small changes in eating and activity" - ], - "diseases": "['Weight Gain']", - "diseases_list": [ - "Weight Gain" - ], - "enrollment": "52.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18-35 \n\n Body mass index between 23 and 30 \n\n Interested in preventing weight gain \n\n ", - "exclusion_criteria": ": \n\n BMI outside of range specified \n\n Age outside of range specified \n\n History of or current eating disorder or substance abuse \n\n Recent weight loss greater than 5% of weight \n\n Currently in another research study that would interfere", - "brief_summary": "The specific aim of the proposed project is to test two separate self-regulation interventions to prevent weight gain in young adults, one based on making sustained small changes in behavior to prevent weight gain and the other on making periodic larger behavior changes resulting in weight loss.", - "NCTID": "NCT00606840" - }, - { - "brief_title": "A Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder", - "phase": "Phase 3", - "drugs": "['Armodafinil', 'Placebo']", - "drugs_list": [ - "Armodafinil", - "Placebo" - ], - "diseases": "['Depression']", - "diseases_list": [ - "Depression" - ], - "enrollment": "433.0", - "inclusion_criteria": "inclusion criteria: \n\n The patient has a diagnosis of bipolar I disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria and is currently experiencing a major depressive episode. \n\n Documentation that the patient has had at least 1 previous manic or mixed episode. \n\n The patient has had no more than 6 mood episodes in the last year. \n\n The patient's current major depressive episode must have started no less than 2 weeks and no more than 12 months prior to the screening visit. The current depressive episode must have begun after the patient's current mood stabilizer regime began. \n\n The patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine, risperidone, or ziprasidone (only if taken in combination with lithium or valproic acid). \n\n Written informed consent is obtained. \n\n The patient is a man or woman 18 through 65 years of age. \n\n The patient is in good health (except for diagnosis of bipolar I disorder) as judged by the investigator, on the basis of medical and psychiatric history, medical examination, electrocardiography (ECG), serum chemistry, hematology, and urinalysis. \n\n Women of childbearing potential (women who have not reached menopause, women who are less than 2 years postmenopausal, and women who are not surgically sterile) who are sexually active must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. \n\n The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol. \n\n The patient has permanent accommodations and means of being contacted by the study center. \n\n The patient understands that they may enroll in this clinical study only once and may not enroll in any other clinical study while participating in this trial. \n\n ", - "exclusion_criteria": ": \n\n The patient has any Axis I disorder apart from bipolar I disorder that was the primary focus of treatment within 6 months of the screening visit or during the screening period. \n\n The patient has psychotic symptoms or has had psychosis within 4 weeks of the screening visit or during the screening period. \n\n The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present. \n\n The patient has a history of an eating disorder or obsessive compulsive disorder (OCD) within 6 months of the screening visit or during the screening period. \n\n The patient has a history of alcohol or substance abuse or dependence (with the exception of nicotine dependence) within 3 months of the screening visit or during the screening period. \n\n The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or a history of multiple clinically relevant allergies. \n\n The patient has any clinically significant uncontrolled medical condition, treated or untreated. \n\n The patient has received modafinil or armodafinil within the past 5 years, or the patient has a known sensitivity to any ingredients in the study drug tablets. \n\n The patient has previously participated in a clinical study with armodafinil or has used any investigational product within 90 days of screening. The patient may not enroll in any other clinical study while participating in this study. \n\n The patient has ever been treated with vagus nerve stimulation (VNS) or deep brain stimulation (DBS), or has been treated with electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) within 3 months of the screening visit. \n\n The patient is a pregnant or lactating woman.", - "brief_summary": "The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.", - "NCTID": "NCT01072929" - }, - { - "brief_title": "Exenatide for the Treatment of Weight Gain Associated With Olanzapine in Obese Adults", - "phase": "Phase 4", - "drugs": "['Exenatide', 'Placebo']", - "drugs_list": [ - "Exenatide", - "Placebo" - ], - "diseases": "['Weight Gain']", - "diseases_list": [ - "Weight Gain" - ], - "enrollment": "54.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects must be between the ages of 18 and 55 years old. \n\n Subjects must have bipolar I disorder, schizophrenia, schizoaffective disorder or MDD as defined by DSM-IV-TR criteria and diagnosed using the Structured Clinical Interview for DSM-IV (SCID). \n\n Subjects must have a Young Mania Rating Scale (YMRS) score < 16 and a Montgomery-Asberg Depression Rating Scale (MADRS) score < 24 at screening and baseline visits. \n\n Subjects must have the Scale for the Assessment of Positive Symptoms (SAPS) scores <2 on all subscales. \n\n Subjects must have gained > 7% of their body weight following treatment with olanzapine as either documented in their medical records or by patient report. \n\n Subjects must be obese, as defined by a current Body Mass Index (BMI) > 30 kg/m2. \n\n Subjects must sign the Informed Consent Document after the nature of the trial has been fully explained. \n\n If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable method(s) of contraception (e.g., hormonal methods, intrauterine device, abstinence) for at least one month prior to study entry and throughout the study. \n\n Subjects must be on a stable dose of olanzapine for at least 14 days and must have been on 5-30mg/day for at least 1 month. \n\n Major ", - "exclusion_criteria": " \n\n Subjects with clinically significant suicidal or homicidal ideation. \n\n Subjects who have a DSM-IV lifetime diagnosis of a substance dependence disorder within the past 6 months or within the past month have been diagnosed with a substance abuse disorder, (except for nicotine abuse or dependence), as determined by psychiatric history or SCID interview. \n\n Subjects with a clinically significant or unstable medical disease, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions, that could interfere with diagnosis, assessment, or treatment of bipolar disorder or obesity, as well as subjects with a history of pancreatitis. \n\n Patients with clinically significant laboratory abnormalities (> 3 times upper limit of normal), on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, or thyroid indices or clinically abnormal ECG. \n\n Female patients who are either pregnant or lactating. \n\n Any female patient whose sexual activity is unknown or in questions. \n\n Any history of current or past diabetes that has been treated with pharmacological intervention. Subjects who have a diagnosis of diabetes, are currently receiving exenatide, insulin, or an oral anti-hyperglycemic medication, or who have a nonfasting blood glucose \u2265 200 mg/dl or a fasting blood glucose \u2265126 mg/dl on 2 separate tests. Subjects with pre-diabetes will not be excluded. \n\n Neurological disorders including epilepsy, stroke, or severe head trauma. Mental retardation (IQ <70). \n\n 10. Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0. \n\n 11. Treatment with concurrent mood stabilizers (except lithium), anticonvulsants, or antipsychotics. \n\n 12. Other psychotic disorders (including delusional disorder, brief psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV. \n\n 13. Dysthymic disorder or depressive disorder not otherwise specified, bipolar disorder not otherwise specified. \n\n 14. Subjects previously enrolled in this study or have previously been treated with exenatide. \n\n 15. Subjects who have received an experimental drug within 30 days. 16. Subjects who are displaying current clinically significant depressive or manic symptoms, defined as a MADRS score >24 or a YMRS score > 16 or who currently meet DSM-IV-TR criteria for a manic, mixed, hypomanic, or depressive episode. \n\n 17. Subjects who are displaying current clinically significant psychotic symptoms, defined as any SAPS subscale score > 2 18. Subjects with a history of pancreatitis in themselves or any risk factors for developing pancreatitis (risk factors include but are not limited to: alcohol use, history of gallbladder disease or gallstones, diabetes or a family history of pancreatitis) 19. Subjects with elevated amylase or lipase levels as measured at the screening visit", - "brief_summary": "The purpose of this research study is to test the safety and efficacy (how well it works) of exenatide as a treatment for weight gain associated with olanzapine in obese adults with Bipolar Disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder~Exenatide has been approved by the FDA for the treatment of Type 2 diabetes.~It has not been approved for the treatment of weight gain associated with olanzapine in obese adults with bipolar disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder", - "NCTID": "NCT00845507" - }, - { - "brief_title": "Ambien CR For Treatment Of Insomnia Associated With Depression When Used Concomitantly With Lexapro", - "phase": "Phase 4", - "drugs": "['zolpidem tartrate']", - "drugs_list": [ - "zolpidem tartrate" - ], - "diseases": "['Insomnia']", - "diseases_list": [ - "Insomnia" - ], - "enrollment": "372.0", - "inclusion_criteria": "MAJOR inclusion criteria: \n\n Must experience sleep disturbances at least 3 nights/week, based on historical data \n\n Must meet the diagnostic requirements for Major Depressive Disorder \n\n Must have QIDS-SR16 score between 6 and 15 \n\n Must be either newly diagnosed or show symptoms of relapse/recurrence of depression while not on medication \n\n Age 21-64, inclusive \n\n Women must use a medically acceptable form of contraception (steroidal contraceptive, double-barrier, or intra-uterine device) during the entire study period, or: be surgically sterilized, post-menopausal, agree to use double-barrier contraception throughout the study period, or must have a negative urine pregnancy test prior to randomization. \n\n Subject must be stabilized on all ongoing long-term medication therapy for at least 28 days prior to screening visit. \n\n MAJOR ", - "exclusion_criteria": ": \n\n Severity of depressive episode had been rated as severe or severe with psychotic features. \n\n History of a suicide attempt or suicidal ideation. \n\n History of mania, manic episode or bipolar disease. \n\n Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization. \n\n Use of prescription and non-prescription sedative drugs given for the purpose of sleep induction or to relieve jet lag \n\n Any abnormal pre-study laboratory values that require clinical intervention \n\n Prior failure to respond to escitalopram therapy for depression \n\n Current depressive episode requiring inpatient hospitalization. \n\n Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous 28 days. \n\n History of drug addiction, alcoholism, or drug abuse. \n\n A positive urine drug screen for medication that would interfere with the assessment of the study medication. \n\n Known allergy to zolpidem, escitalopram or any of their excipients \n\n History of sleep apnea \n\n History of myasthenia gravis \n\n The presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebrovascular disease or malignancy. \n\n Pregnant or breastfeeding \n\n Subject is participating in another clinical trial, or has completed another clinical trial within 28 days prior to screening.", - "brief_summary": "To demonstrate overall improvement of insomnia in subjects treated with zolpidem tartrate extended-release (Ambien CR) and escitalopram (Lexapro) vs. subjects treated with placebo and escitalopram at 2 months.", - "NCTID": "NCT00296179" - }, - { - "brief_title": "Zonegran for the Treatment of Weight Gain Associated With Psychotropic Medication Use: A Placebo-Controlled Trial", - "phase": "Phase 4", - "drugs": "['Zonegran', 'Placebo']", - "drugs_list": [ - "Zonegran", - "Placebo" - ], - "diseases": "['Obesity']", - "diseases_list": [ - "Obesity" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Are men or women, between the ages of 19 and 65, inclusive \n\n Have a diagnosis of any type of bipolar disorder or any type of psychotic disorder based on structured diagnostic interview (MINI). \n\n Are currently outpatients or inpatients and taking a neuroleptic or mood stabilizer medication (listed below) for the past 6 months, and on a stable dose for the past 2 months. \n\n Have a body mass index > 25. \n\n No substance use disorder in the past 2 months (except for nicotine or caffeine). \n\n Agree to not become pregnant during the study and agree to use an adequate method of birth control during the study such as a barrier method, hormonal contraceptive, or surgical sterilization (females only). All women of childbearing potential must have a negative pregnancy test before beginning study medication. \n\n Are able to swallow the capsules whole \n\n Are willing and able to follow Investigator instructions and study procedures, and report adverse events \n\n Not currently actively suicidal or homicidal. \n\n No use of topiramate within the last 6 months. \n\n No medical contraindication to the use of zonisamide. \n\n List of medications for inclusion criterion #3: \n\n All conventional neuroleptics. All atypical neuroleptics except aripiprazole or ziprasidone. All forms of valproate. All forms of lithium. All forms of carbamazepine. \n\n ", - "exclusion_criteria": ": \n\n Clinically significant renal or hepatic disease. \n\n History of acute intermittent porphyria, glucose-6phosphate dehydrogenase deficiency or hemolytic anemia. \n\n Allergy to zonisamide or sulfonamides. \n\n Have clinically unstable cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, or other systemic disease \n\n Have laboratory test results that, in the opinion of the Investigator, are clinically significant abnormalities \n\n Require treatment with any medication (e.g., carbonic anhydrase inhibitors) that might interact adversely with, or obscure, the action of the study drug \n\n Are pregnant or lactating (females only) \n\n Have a history of nephrolithiasis \n\n Refuse to give informed consent \n\n Have previously enrolled in this study or previously been treated with zonisamide", - "brief_summary": "The primary objective of this study is to compare the efficacy of zonisamide (Zonegran; 100mg - 400mg/day) and placebo as an adjunctive agent on lowering weight in subjects who have a body mass index (BMI) of >25 and are on a psychotropic medication with a known side effect of weight gain.", - "NCTID": "NCT00203450" - }, - { - "brief_title": "Effects of Cognitive Behavioral Therapy on Brain Serotonin Activity in People With Depression", - "phase": "Phase 2; Phase 3", - "drugs": "['ADAM SPECT plus Cognitive Therapy', 'ADAM SPECT plus No Therapy']", - "drugs_list": [ - "ADAM SPECT plus Cognitive Therapy", - "ADAM SPECT plus No Therapy" - ], - "diseases": "['Depression']", - "diseases_list": [ - "Depression" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n DSM-IV diagnosis of major depressive disorder (MDD) \n\n Drug naive from prior psychotropic medication for more than 6 months before study entry \n\n Hamilton-Depression (HAM-D) 17 score greater than or equal to 16 \n\n Woman of childbearing age with a negative pregnancy test within 48 hours of scanning \n\n ", - "exclusion_criteria": ": \n\n DSM-IV Axis I diagnosis other than MDD \n\n Use of psychotropic medication within 6 months of study entry \n\n History of bipolar disorder \n\n Current alcohol or drug abuse/dependence within 6 months of study entry \n\n History of sensitivity or intolerance to s-citalopram \n\n Medical contraindication to the use of s-citalopram \n\n Unstable medical condition (e.g., angina pectoris, untreated hypertension) \n\n Pregnant or nursing \n\n Woman of childbearing potential not using a medically acceptable form of birth control \n\n Actively suicidal or requiring hospitalization \n\n Requiring additional psychotropic drug therapy \n\n History of transient ischemic attacks \n\n History of cerebral infarction (including lacunar infarct with symptoms more than 24 hours in duration) \n\n History of Binswanger's disease or a history of hypertensive encephalopathy \n\n History of intracranial hemorrhage \n\n History of head trauma with loss of consciousness \n\n History of encephalitis \n\n History of extended exposure to known neurotoxin (e.g., cyanide, carbon monoxide) \n\n Uncontrolled metabolic disorder (e.g., thyroid disease, diabetes mellitus) \n\n History of cognitive impairment other than major depressive episode \n\n History of normal pressure hydrocephalus \n\n History of cancer metastatic to the central nervous system \n\n History of Parkinson's or other basal ganglia disease \n\n History of Guillain-Barr\u00e9 syndrome (chronic or relapsing polyneuropathy) \n\n Inability to undergo an MRI scan", - "brief_summary": "This study will examine changes in brain serotonin activity in people with depression before and after they receive cognitive behavioral therapy.", - "NCTID": "NCT00641108" - }, - { - "brief_title": "Reducing Symptoms of Depression in Low-Income Mothers", - "phase": "Phase 2", - "drugs": "['Modified Interpersonal Therapy', 'Attention control/usual care']", - "drugs_list": [ - "Modified Interpersonal Therapy", - "Attention control/usual care" - ], - "diseases": "['Depression']", - "diseases_list": [ - "Depression" - ], - "enrollment": "226.0", - "inclusion_criteria": "inclusion criteria: \n\n Score of 16 or higher on the Center for Epidemiological Studies Depression (CES-D) Scale \n\n Child who is 6 weeks to 30 months old \n\n Child who is enrolled in an Early Head Start program \n\n ", - "exclusion_criteria": ": \n\n Regular use of psychotropic medication \n\n Regular use of psychotherapy or drug/alcohol treatment", - "brief_summary": "This study will test the effectiveness of a short-term intervention in treating depressed young mothers with young children enrolled in Early Head Start Programs.", - "NCTID": "NCT00074789" - }, - { - "brief_title": "Bupropion and Weight Control for Smoking Cessation - 1", - "phase": "Phase 4", - "drugs": "['Bupropion', 'Placebo', 'weight concerns intervention', 'smoking cessation intervention']", - "drugs_list": [ - "Bupropion", - "Placebo", - "weight concerns intervention", - "smoking cessation intervention" - ], - "diseases": "['Tobacco Use Disorder']", - "diseases_list": [ - "Tobacco Use Disorder" - ], - "enrollment": "349.0", - "inclusion_criteria": "inclusion criteria: \n\n Smoke at least 10 cigarettes per day \n\n Report concern about cessation-related weight gain \n\n Motivated to quit smoking \n\n ", - "exclusion_criteria": ": \n\n Currently pregnant, lactating, or no medically approved method of contraception \n\n Major medical problem \n\n History of seizure disorder or head injury \n\n Current or historical psychosis or bipolar disorder \n\n History of alcohol or substance abuse within previous year \n\n Current or historical eating disorder \n\n Use of antidepressant medication, monoamine oxidase inhibitor or lithium with previous month \n\n Multiple Drug Allergies \n\n Current major depressive disorder", - "brief_summary": "The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.", - "NCTID": "NCT00006170" - }, - { - "brief_title": "Zolpidem CR and Hospitalized Patients With Dementia", - "phase": "", - "drugs": "['Zolpidem CR', 'Placebo']", - "drugs_list": [ - "Zolpidem CR", - "Placebo" - ], - "diseases": "['Dementia', 'Alzheimer Disease', 'Dementia, Vascular', 'Sleep Disorders', 'Circadian Dysregulation']", - "diseases_list": [ - "Dementia", - "Alzheimer Disease", - "Dementia", - "Vascular", - "Sleep Disorders", - "Circadian Dysregulation" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Age between 60-99 years \n\n Clinical diagnosis of Dementia of the Alzheimer's type or Vascular Dementia \n\n Only subjects with Mini Mental Status Examination scores of greater or equal to 10 will be enrolled. \n\n ", - "exclusion_criteria": ": \n\n Subjects who are too agitated to be able to wear the activity monitors; \n\n Subjects who are actively suicidal or homicidal or for whom the clinical treatment team considers participation in the study to be unsuitable; \n\n Subjects with untreated primary sleep disorders; \n\n Subjects who receive hypnotic medications during their participation in the study; Subjects who received hypnotic medications prior to enrollment may participate in the study if they agree to stop receiving hypnotic medications (with their attending physician's approval); \n\n Subjects who are receiving over the counter sleep aids; \n\n Subjects who can not commit to abstaining from alcohol use while in the study; \n\n Subjects with known anaphylactic reaction or angioedema with Zolpidem CR.", - "brief_summary": "The purpose of this research study is to compare the effectiveness of Zolpidem CR to that of placebo in improving sleep efficiency in people with dementia admitted to the hospital because of their symptoms. You can participate in this study if you have dementia of the Alzheimer's type or vascular dementia. This study involves placebo; a placebo is a tablet that looks exactly like Zolpidem CR, the study drug, but contains no active study drug. We will use placebos to see if the study results are due to the study drug or due to other reasons. Zolpidem CR is also called Ambien CR and is widely available by prescription. Zolpidem CR is approved by the U.S. Food and Drug Administration (FDA) for the short-term treatment of insomnia (trouble falling or staying asleep).", - "NCTID": "NCT00814502" - }, - { - "brief_title": "Evaluation of the Efficacy and Safety of Olanzapine for Anorexia Nervosa in Children and Adolescents", - "phase": "Phase 3", - "drugs": "['Olanzapine']", - "drugs_list": [ - "Olanzapine" - ], - "diseases": "['Eating Disorder']", - "diseases_list": [ - "Eating Disorder" - ], - "enrollment": "38.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female between 11 and 17 (less than 18) at beginning of trial \n\n Based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), patient fulfills criteria for diagnosis of Anorexia Nervosa (of which there are two types: restricting or binge-eating/purging) or Eating Disorder Not Otherwise Specified, with a weight of less than or equal to 85% of his or her ideal body weight, as can best be determined at the time of assessment \n\n Treated by physician on the eating disorder team at the Children's Hospital of Eastern Ontario (CHEO) \n\n ", - "exclusion_criteria": ": \n\n Currently receiving treatment with any other antipsychotic medication, mood stabiliser, or stimulant \n\n Known diagnosis of: diabetes, impaired glucose tolerance, hyperlipidemia, hepatic dysfunction, substance dependence, narrow angle glaucoma, paralytic ileus, or pancreatitis, or any other medical illness that would be considered to significantly impact treatment or recovery from the eating disorder \n\n Any uncontrolled comorbid disease affecting any system including infectious, endocrine, renal, gastroenterologic, respiratory, cardiac, immunologic, or hematologic. Potential participants with controlled comorbidities in these areas may be invited to participate at the discretion of the primary investigator. \n\n Experienced one or more seizures without clear and resolved etiology \n\n Inability to comply with trial requirements including lack of comprehension of English \n\n Pregnant or breast-feeding \n\n High blood pressure \n\n Known allergy or known sensitivity to products in olanzapine \n\n Other unspecified reasons that, in the opinion of the investigator, amke the patient unsuitable for enrollment \n\n Officially declared incapable of consenting to treatment under the Mental Health Act (Note: If a patient is involuntarily hospitalized, he or she can be invited to participate provided that he or she has not officially been deemed incapable of making treatment decision under the Mental Health Act) \n\n Clinically judged to be at serious suicidal ris \n\n More than 6 months have passed between the patient's initial eating disorder assessment and the time of study entry \n\n Liver function test (ALT) > 1.5 x upper limit of normal (ULN) \n\n Positive pregnancy test \n\n Electrocardiogram (ECG): QTc > 450 msec or arrythmia other than sinus bradycardia; conduction abnormalities, prolonged QTc or other \n\n LDL-C > 4.9 mmol/L \n\n Total cholesterol/HDL ratio > 6 \n\n Fasting glucose > or equal to 6.1 mmol/L \n\n Neutrophil count < 0.5 x 10^9/L \n\n Prolactin level at assessment > 200 ng/mL", - "brief_summary": "The purpose of this trial is to evaluate the safety and efficacy of the atypical antipsychotic, olanzapine, for the treatment of youth suffering from Anorexia Nervosa (AN).~Adolescent males and females between the ages of 11 and 17 years who are being treated by a physician on the Eating Disorder team at the Children's Hospital of Eastern Ontario will be invited to join the study if they have been diagnosed with AN or Eating Disorder Not Otherwise Specified (EDNOS), and if they weigh less than or equal to 85% of their ideal body weight. Those who meet inclusion and not exclusion criteria, and consent to participating in the trial will be offered adjunctive treatment with olanzapine. Those who agree to take olanzapine will belong to the olanzapine group, and those who decline will belong to the comparison group. Olanzapine doses will be in keeping with the investigators current clinical practice, with flex doses ranging from 1.25 mg to 10.0 mg daily (the majority of patients are treated with 2.5 mg or 5.0 mg at bedtime); dose adjustments made based on individual need and tolerability. Participants will remain in the study for 12 weeks. Those who initially decline olanzapine treatment may change their minds and take olanzapine up until week 9 of the trial.~It is hypothesized that those children and adolescents who choose to take olanzapine at entry into the trial will be more motivated to recover and more compliant with treatment. Compared to those who do not receive medication, it is expected that these adolescents will demonstrate reduced disordered eating attitudes and behaviours, as well as an increased rate of weight gain.~Finally, it is predicted that the rates of discontinuation and the adverse effects of olanzapine will be minor given the relatively low dose (as compared to treatment for patients with schizophrenia), slow titration, and short-term use of olanzapine the investigators will be using.~By comparing the well-being and outcome of patients in the two groups, the investigators hope to begin to answer the question of whether olanzapine does or does not lead to improved clinical outcome for patients with severe eating disorders such as AN or EDNOS, and the question of whether the benefits of using the medication outweigh the risks.", - "NCTID": "NCT01184443" - }, - { - "brief_title": "Medication, Weight Gain and GI Hormones", - "phase": "Phase 4", - "drugs": "['orally-disintegrating olanzapine', 'regular olanzapine']", - "drugs_list": [ - "orally-disintegrating olanzapine", - "regular olanzapine" - ], - "diseases": "['Bipolar Depression']", - "diseases_list": [ - "Bipolar Depression" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n A principal diagnosis of bipolar 1 or II disorder \n\n Ages 18-60 \n\n Physically healthy \n\n Outpatient status \n\n Montgomery-Asberg Rating Scale (MADRS) Score greater than or equal to 15 \n\n BMI 23-30 \n\n Able and willing to give written informed consent \n\n ", - "exclusion_criteria": ": \n\n Prior history of diabetes (types I or II) \n\n BMI>30 \n\n Non-fasting blood glucose >124 \n\n Fasting blood glucose >125 or random blood glucose >200 \n\n Presence of dyslipidemia (baseline total cholesterol >240, HDL<50, LDL>160, triglycerides >199) \n\n Current or past history of a non-affective psychotic disorder \n\n Alcohol or other substance abuse or dependence in the 6 months prior to the evaluation (except for caffeine) \n\n Current use of any nicotine products \n\n Schizoid, schizotypal, or borderline personality disorder \n\n Treatment with olanzapine in the prior 3 months or any history of non- response to or intolerance of olanzapine or the olanzapine-fluoxetine combination (SymbiaxTM) \n\n Suicide potential that, in the opinion of the investigator, precludes outpatient treatment or participation in a trial \n\n Participation of subjects in another drug trial within 30 days of evaluation \n\n The presence of any current medical condition judged by the investigator to potentially interfere with the study procedures or measures \n\n The likelihood of requiring hospitalization over the period of the study \n\n The presence of any clinically-significant laboratory abnormality as judged by the investigator \n\n Pregnancy or lactation \n\n History of seizure disorder, excluding febrile seizures of childhood \n\n Any disorder of taste or smell, including severe nasal allergies \n\n Any other condition which, in the investigator's judgment might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study \n\n Being unable to comprehend or follow the study procedures.", - "brief_summary": "This is an 8 week study that compares two medications. One medication is olanzapine (5-20 mg daily) whereas the other medication is an orally disintegrating medication. Both medications are used to treat depressed bipolar patients. The main focus of this study is the comparison of these two medications on gastro-intestinal hormones and weight gain.", - "NCTID": "NCT00384332" - }, - { - "brief_title": "Pilot Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate Instant-Release (Seroquel IR) in Controlling Agitation and Aggressive Symptoms in the Acute Treatment of Patients With Schizophrenia", - "phase": "Phase 4", - "drugs": "['Quetiapine fumarate', 'Haloperidol']", - "drugs_list": [ - "Quetiapine fumarate", - "Haloperidol" - ], - "diseases": "['Acute Schizophrenia']", - "diseases_list": [ - "Acute Schizophrenia" - ], - "enrollment": "70.0", - "inclusion_criteria": "inclusion criteria: \n\n Provision of written informed consent by both patient and legal representative \n\n A diagnosis of schizophrenia by Chinese Classification and Diagnostic Criteria of Mental Disorder, 3rd version (CCMD-3) \n\n Male or female, aged 18 to 65 years \n\n MOAS total score \u00b3 10 at both screening and randomization \n\n Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment \n\n Able to understand and comply with the requirements of the study \n\n ", - "exclusion_criteria": ": \n\n Pregnancy or lactation \n\n Any CCMD-3 not defined in the inclusion criteria \n\n Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others \n\n Known intolerance or lack of response to quetiapine fumarate or haloperidol, as judged by the investigator \n\n Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir \n\n Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids \n\n Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation \n\n Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by CCMD-3 criteria \n\n Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by CCMD-3 criteria within 4 weeks prior to enrolment \n\n Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment \n\n Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator \n\n Involvement in the planning and conduct of the study \n\n Previous enrolment or randomisation of treatment in the present study. \n\n Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements \n\n A patient with Diabetes Mellitus (DM) \n\n An absolute neutrophil count (ANC) of \u00a3 1.5 x 109 per liter \n\n 2 times higher than the normal upper limit of ALT or AST. \n\n Use of clozapine within 28 days prior to randomisation", - "brief_summary": "Quetiapine fumarate is indicated for the treatment of patients with schizophrenia in China. Lots of clinical experience and evidence has demonstrated its efficacy and tolerability for the patient population. Some evidence showed that quetiapine fumarate could control aggression and agitation within 1 week, which is appropriate for the acute treatment of patients with schizophrenia. PANSS and MOAS are the common measurements for the efficacy of psychotic symptoms controlling in the clinical trials. Generally, 2 weeks are the appropriate timeframe for the evaluation of clinical effect of agitation and aggression symptoms controlling.~In adult patients with schizophrenia, quetiapine fumarate is licensed to maximal dose of 750mg/day. The target dose of quetiapine fumarate recommended in the manufacturer's prescribing information is 300-450 mg/day in China, though similar efficacy for quetiapine fumarate (600 mg/day), olanzapine (15 mg/day) and Risperidone (5 mg/day) was reported in a small, randomised, rater-blinded trial. Because of the low incidence of EPS, the limitation potential for weight gain and prolactin elevation, quetiapine fumarate should be well tolerated in this sensitive patient population with higher dose (600mg/day-750mg/day) (Peuskens 2004).~The aim of the present study is to evaluate the efficacy and safety of quetiapine fumarate with daily dose 600-750mg/day in improving agitation and aggression for the treatment of Chinese acute schizophrenic patients hospitalised for acute phase over a treatment period of 2 weeks", - "NCTID": "NCT00838032" - }, - { - "brief_title": "Treatment on Iatrogenic Weight Gain and Dyslipidaemia Associated With Olanzapine", - "phase": "Phase 2", - "drugs": "['GWP42003 : GWP42004 (40:1)', 'Placebo']", - "drugs_list": [ - "GWP42003 : GWP42004 (40:1)", - "Placebo" - ], - "diseases": "['Schizophrenia']", - "diseases_list": [ - "Schizophrenia" - ], - "enrollment": "2.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis (DSM-IV) of schizophrenia or functional psychosis including schizophreniform and acute psychosis with schizophrenia symptoms \n\n Receiving olanzapine treatment for no more than 3 months \n\n The dose of olanzapine is stable for at least 2 weeks prior to randomisation (Visit 2) and subject is willing to maintain a stable dose of olanzapine for the duration of the study \n\n Evidence of weight gain in the last 3 months attributable to olanzapine, prior to screening (Visit 1). Wherever possible, investigator must exclude other possible causes of weight gain, such as change in exercise, diet, or other illnesses \n\n Each subject must have further weight gain attributable to olanzapine, in the baseline period (between Visits 1 and 2) no more than 5 months subsequent to commencement of olanzapine treatment \n\n Willing to maintain a stable dose of any concomitant medications, and have been on a stable dose for a minimum of 6 weeks (with the exception of olanzapine) \n\n No changes in diet or exercise for 6 weeks prior to screening (Visit 1) and subject agrees to maintain stability, for the duration of the study (in the opinion of the investigator) \n\n ", - "exclusion_criteria": ": \n\n Subject has Axis I (DSM-IV) diagnosis of schizoaffective disorder; \n\n Subject has drug induced or toxic psychosis (in the opinion of the investigator) \n\n Subject presents with a clinical picture and/ or history that is consistent with delirium, dementia, amnesia or other cognitive disorder; bipolar disorder or major depression \n\n Subject has a significant history of anxiety, suicidal ideation or self-harm based on history or routine psychiatric status examination (in the opinion of the investigator) \n\n Subject has an unstable thyroid pathology (including hypo or hyperthyroidism), within the past six months (in the opinion of the investigator) \n\n Subject has a history of neuroleptic malignant syndrome; \n\n Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2 month period prior to randomisation (Visit 2) \n\n Subject has a clinical diagnosis of diabetes \n\n Subject is taking insulin (i.e. they are insulin dependent) or have had insulin within 6 months prior to the screening visit (Visit 1); \n\n Any known or suspected history of (in the opinion of the investigator): \n\n alcohol or substance abuse \n\n epilepsy or recurrent seizures \n\n Any known or suspected history of depression sufficient to require treatment or disrupt ordinary life (excluding episodes of reactive depression - in the opinion of the investigator) \n\n BDI Score \u2265 15 (at Visit 1 or 2) \n\n Clinically significant cardiac, renal or hepatic impairment in the opinion of the investigator \n\n Genetic dyslipidaemic condition in the opinion of the investigator \n\n Female patients of child-bearing potential and male patients whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (however, a male condom should not be used in conjunction with a female condom as this may not prove effective) \n\n Travel outside the country of residence planned during the study treatment period \n\n Having received olanzapine treatment continuously for more than 3 months prior to screening (Visit 1) \n\n Received an Investigational Medicinal Product within the 90 days before the screening visit (Visit 1) \n\n Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, influence the result of the study, or the subject's ability to participate in the study", - "brief_summary": "Olanzapine is one of the most effective and best tolerated of the atypical antipsychotics, but it is also particularly associated with weight gain and metabolic problems.~This study is being conducted by GW Pharma Ltd as a pilot study in order to determine the efficacy and safety of two medications GW42003 and GW42004 as a 40:1 ratio when combined with the subjects existing treatment of olanzapine in subjects with weight gain attributable to olanzapine treatment for functional psychosis. This is the first study to determine whether the study medications have a positive benefit for subjects on their cholesterol levels, body weight and other metabolic parameters, as well as a potential augmentation of the anti-psychotic effect of olanzapine.~This is a multi-centre randomised, double-blind, placebo-controlled, parallel-group pilot study. There will be two groups of subjects (GWP42003 plus GWP42004 (40:1 ratio) and placebo), with a treatment duration of 6 weeks as well as a baseline period of variable length and one week follow-up. The two treatment groups will be randomised equally.~In order to be eligible for enrollment in this study, subjects will need to be aged 18 years and above and be clinically diagnosed with functional psychosis and receiving olanzapine treatment for no more than 3 months with evidence of weight gain attributable to olanzapine treatment.~Eligible subjects will enter the study at a screening visit (Visit 1) and commence a baseline period. Subjects will also be assessed at Visit 2 for further weight gain during the baseline period. The baseline period is flexible in length to allow time for this weight gain to be achieved and also for the olanzapine dose to be stabilised. If eligible the subject will be randomised into the 6-week treatment phase. There are a total of 6 visits in the study.", - "NCTID": "NCT01491490" - }, - { - "brief_title": "TRIAD Project: Qualitative Study of Adolescent Depression and Smoking", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Adolescent - Emotional Problem', 'Smoking']", - "diseases_list": [ - "Adolescent - Emotional Problem", - "Smoking" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n 12-19 years old \n\n Major depression \n\n Smoke cigarettes \n\n Lives with parents \n\n No confidentiality issues related to smoking \n\n ", - "exclusion_criteria": ": \n\n Non English speaking \n\n Suicidal ideation \n\n Pregnant", - "brief_summary": "It has been shown in the adult literature that smoking is related to depression and visa versa. Not much is known about how this relationship is started or if one perhaps leads to the other. We are performing 1 hour long interviews with adolescents ages 12-19 who meet criteria for major depression and who smoke. They are interviewed along with their parent. Questions center around their view of depression and their history of depression as well as questions around their smoking as well as the interrelationships between the two. Transcripts are made of the interview and are being analyzed for themes.", - "NCTID": "NCT00592696" - }, - { - "brief_title": "Efficacy Study of Quetiapine Plus Topiramate for Reducing Cannabis Consumption and Bipolar Mania", - "phase": "Phase 4", - "drugs": "['Quetiapine and placebo', 'Quetiapine and Topiramate']", - "drugs_list": [ - "Quetiapine and placebo", - "Quetiapine and Topiramate" - ], - "diseases": "['Bipolar Disorder', 'Cannabis-Related Disorder']", - "diseases_list": [ - "Bipolar Disorder", - "Cannabis-Related Disorder" - ], - "enrollment": "75.0", - "inclusion_criteria": "Inclusion/", - "exclusion_criteria": " inclusion criteria: To be included, all subjects must\u2026 \n\n have an authorized parent/legal guardian who understands the nature of the study and who provides written informed consent if the study subject is younger than 18 years of age. Additionally, each subject must provide assent to the study; \n\n be fluent in English; \n\n be 12 to 21 years of age, inclusive; \n\n be using a medically accepted means of contraception (i.e., oral contraceptives and barrier methods (diaphragm or condom), medroxyprogesterone acetate injectable suspension, abstinence) if female and of menarche. Oral contraceptives alone are not acceptable means of contraception because concomitant use of topiramate and low estrogen oral contraceptive pills may lead to oral contraceptive failure; \n\n have a diagnosis of bipolar I disorder in a current manic or mixed episode, in addition to a cannabis use disorder (which includes abuse or dependence) within 28 days prior to screening, as determined by the WASH-U-KSADS; \n\n have an initial YMRS total score of >16 at screening and baselines; \n\n use cannabis a minimum of twice per week on average during the 28 days prior to screening. \n\n ", - "brief_summary": "The objectives of this study are to determine whether this treatment may be useful for reducing cannabis consumption; reducing symptoms of bipolar mania; and weight mitigation therapy for individuals on psychopharmacotherapy.", - "NCTID": "NCT00393978" - }, - { - "brief_title": "Group Intervention for Interpersonal Trauma", - "phase": "", - "drugs": "['Group Intervention for Interpersonal Trauma', 'Information only']", - "drugs_list": [ - "Group Intervention for Interpersonal Trauma", - "Information only" - ], - "diseases": "['Post-Traumatic Stress Disorder', 'Depression']", - "diseases_list": [ - "Post-Traumatic Stress Disorder", - "Depression" - ], - "enrollment": "27.0", - "inclusion_criteria": "inclusion criteria: \n\n Exposure to an interpersonal traumatic event \n\n Diagnosis of depression or PTSD (threshold or subthreshold) \n\n Functional literacy \n\n ", - "exclusion_criteria": ": \n\n Apparent incoherence or disorientation \n\n Apparent intoxication at recruitment \n\n Hearing impairment", - "brief_summary": "This study will assess the acceptability and effectiveness of a six-session, modular, repeating group for low-income women who have symptoms of depression and/or post-traumatic stress disorder following interpersonal trauma exposure.", - "NCTID": "NCT00348036" - }, - { - "brief_title": "The Study of Spectrum of Sleep Disorders in Cirrhotic Patients and the Efficacy of Zolpidem in Cirrhotic Patients With Insomnia", - "phase": "", - "drugs": "['Zolpidem', 'placebo']", - "drugs_list": [ - "Zolpidem", - "placebo" - ], - "diseases": "['Cirrhosis']", - "diseases_list": [ - "Cirrhosis" - ], - "enrollment": "52.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 to 70 years \n\n Clinical, Biochemical, Radiological ,Histological evidence of cirrhosis of all etiology \n\n Child A and B cirrhosis (for intervention part) \n\n Cirrhosis patients giving h/o persistent sleep disturbances (PSQI\u22655) \n\n Child A, B and C cirrhosis (for observational part) \n\n ", - "exclusion_criteria": ": \n\n Active alcohol intake or intake within 1 month of enrollment \n\n Active substance abuse or intake within 1 month of enrollment \n\n Known psychiatric and neurological disorders \n\n Patient using antidepressant, anticonvulsants, other hypnotics \n\n Pregnancy or lactation \n\n Overt hepatic encephalopathy (grade 2,3,4) \n\n Child C cirrhosis (for intervention part) \n\n Acute decompensated state of CLD (Chronic Liver Disease) - GastroIntestinal bleed, increased jaundice, HE (Hepatic Encepahlopahty) , SBP (Spontaneous Bacterial Peritonitis). \n\n HCC (HepatoCellular Carcinoma) with portal vein thrombosis \n\n Acute febrile illness/ acute infection \n\n Post TIPS (Transjugular Intrahepatic Portosystemic shunt)patient", - "brief_summary": "All Cirrhosis liver patients (Child A/B/C) presenting to Institute of Liver and Biliary Sciences will be screened for sleep disturbance and excessive daytime sleepiness with Epworth sleep score/ Pittsburgh sleep quality index. 52 patients of clinical/ radiological/ biopsy proven cirrhosis (Child A/B) will be enrolled after ruling out possibility of psychiatric illnesses like depression and anxiety with the help of PHQ-9 / GAD-7 questionnares. Patients who are suffering with sleep disturbance as evaluated with Pittsburgh sleep quality index will undergo polysomnography and will be randomised to two groups after fulfilling all inclusion criterias. Patients in group (Group 1) will receive zolpidem 5mg at bed time daily and patients in control group will receive placebo at bed time daily. The treatment will be continued for 4 weeks. After 4 weeks enrolled patients will be reassessed with PSQI and polysomnography. All patients will be advised regarding sleep hygiene.", - "NCTID": "NCT02484963" - }, - { - "brief_title": "A Study of FK199B to Compare Efficacy With Zolpidem by Polysomnography in Patients With Insomnia", - "phase": "Phase 3", - "drugs": "['FK199B', 'Zolpidem']", - "drugs_list": [ - "FK199B", - "Zolpidem" - ], - "diseases": "['Sleep Initiation and Maintenance Disorders']", - "diseases_list": [ - "Sleep Initiation and Maintenance Disorders" - ], - "enrollment": "55.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient is diagnosed as a primary insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) \n\n Patients complaining of insomnia continuously for 4 weeks or longer \n\n Patient's usual bedtime is between 9 p.m. and 12 a.m. for the 4 week period prior to initial screening \n\n Patient on most occasions sleeps for a total of \u22653 and <6.5 hours over the 4 week period prior to initial screening \n\n Patient's usual wake time after sleep onset in a single night is \u226545 minutes per night for the 4 week period prior to initial screening \n\n Patients have a body weight of \u226545 kg and \u226485 kg, a BMI of \u226518.5 and <30 \n\n ", - "exclusion_criteria": ": \n\n Patients with schizophrenia or manic-depressive psychosis \n\n Patients with insomnia caused by physical diseases including chronic obstructive pulmonary disease, bronchial asthma, fibrositis syndrome, chronic fatigue syndrome, rheumatic disease, climacteric disturbance, and dermatitis atopic \n\n Patients with circadian rhythm sleep disorder \n\n Patient works night shifts \n\n Patients with alcoholic sleep disorder \n\n Patients with alcohol or drug dependence or a history of these \n\n Patients with insomnia related with drugs including antiparkinson, antihypertensive, or steroid drugs \n\n Patients with sleep apnea syndrome \n\n Patients with restless legs syndrome or periodic limb movement disorder \n\n Patients with epileptic insomnia \n\n Patients smoke on average 40 or more cigarettes a day \n\n Patients who had received psychotropic drugs other than hypnotics (including anxiolytic or antidepressant drugs for hypnotic effect) within a 4 week period prior to the initial screening", - "brief_summary": "This study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) by polysomnography in patients with insomnia, excluding patients with schizophrenia or manic-depressive psychosis.", - "NCTID": "NCT00999219" - }, - { - "brief_title": "Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing", - "phase": "Phase 4", - "drugs": "['Zolpidem', 'Sugar Pill']", - "drugs_list": [ - "Zolpidem", - "Sugar Pill" - ], - "diseases": "['Insomnia', 'Primary Insomnia', 'Psychophysiologic Insomnia']", - "diseases_list": [ - "Insomnia", - "Primary Insomnia", - "Psychophysiologic Insomnia" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Ages 25 - 55 \n\n a stable sleep/wake schedule with a preferred sleep phase between 10:00 p.m. and 8:00 a.m. \n\n Patients with Primary Insomnia will meet diagnostic criteria for Psychophysiologic Insomnia according to the International Classification of Sleep Disorders manual (ICSD). \n\n complaint of disturbed sleep must have the following characteristics: >30 minutes to fall asleep, and/or >30 minutes wake after sleep onset time, a total sleep time of no more than 6.5 hours (or a sleep efficiency of less than 85%), a problem frequency of >4 nights/ week and a problem duration >6 months. \n\n ", - "exclusion_criteria": ": \n\n Unstable medical or psychiatric illness \n\n Use of medication that may cause insomnia or may be reduce the effectiveness of zolpidem (e.g. selective serotonin reuptake inhibitors(SSRI's), steroids, bronchodilators, calcium channel blockers, beta blockers, etc.) \n\n symptoms suggestive of sleep disorders other than insomnia \n\n polysomnographic data indicating sleep disorders other than insomnia \n\n Evidence of active illicit substance use or fitting criteria for alcohol abuse or dependence \n\n inadequate language comprehension \n\n pregnancy \n\n first-degree relatives with bipolar disorder or schizophrenia", - "brief_summary": "We want to assess whether how and when one takes sleep medication results in similar or different outcomes with respect to symptom relief. We also want to know whether taking medication for a period of time provides continued benefit once the medication is stopped.", - "NCTID": "NCT00156533" - }, - { - "brief_title": "Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain", - "phase": "Phase 2", - "drugs": "['Betahistine', 'Placebo Oral Tablet']", - "drugs_list": [ - "Betahistine", - "Placebo Oral Tablet" - ], - "diseases": "['Schizophrenia', 'Schizoaffective Disorder', 'Schizophreniform Disorder', 'Bipolar I Disorder', 'Bipolar II', 'Bipolar NOS(Not Otherwise Specified)', 'Psychotic Disorder Not Otherwise Specified', 'Autism Spectrum Disorder']", - "diseases_list": [ - "Schizophrenia", - "Schizoaffective Disorder", - "Schizophreniform Disorder", - "Bipolar I Disorder", - "Bipolar II", - "Bipolar NOS(Not Otherwise Specified)", - "Psychotic Disorder Not Otherwise Specified", - "Autism Spectrum Disorder" - ], - "enrollment": "48.0", - "inclusion_criteria": "inclusion criteria: \n\n Adolescents and Adults ages 12-59 with a diagnosis of Schizophrenia, Schizoaffective Disorder, Schizophreniform, Bipolar I, Bipolar II, Bipolar NOS or Psychotic Disorder NOS, Autism Spectrum Disorder \n\n Patients will be currently treated with antipsychotics \n\n Patients will qualify for entry if they meet the following weight criteria: \n\n The patient has gained 7% of their weight since beginning of treatment with one or more of the current antipsychotics. \n\n The patient has had an increase of 7% of their weight during the last year while being treated with antipsychotics. \n\n The patient has a BMI of 30 or more and has gained 10 lbs or more in the past 8 months while being treated with antipsychotic medications. \n\n The patient has a BMI of 35 or greater at the current time, and his chart shows a history of consistent weight gain over the past 1 to 3 years during treatment with antipsychotics. \n\n . \n\n ", - "exclusion_criteria": ": \n\n Subjects will be excluded if they have asthma, peptic ulcer disease (diseases which may be exacerbated by a histamine analog), or history of pheochromocytoma or peptic ulcer disease. Patients will be excluded if they are prescribed medications known to affect body weight or glucose-lipid metabolism, such as prescription or over the counter medications taken for the purpose of weight reduction. Subjects who are currently treated with metformin, for less than 6 months and have shown recent weight change on metformin. Patients on thyroid replacement therapy or lipid-lowering agents whose dosage has changed by more than 50 % in the past month will be excluded. If they are relatively stable doses of these medications they will not be excluded. Patients who are on lipid lowering medication, thyroid replacement medication, or diabetes medication, (excluding metformin), must remain on these medications throughout the period of the study. Females who are pregnant or breast feeding will be excluded.", - "brief_summary": "The study attempts to evaluate a histamine analog long used for the treatment of Meniere's disease, betahistine, that shows promise in reversing the antihistaminergic effects thought to be involved in antipsychotic induced weight gain.~Hypothesis to be tested:~A. Patients who have gained a developmentally inappropriate amount of weight on antipsychotics (AP) will see their weight and BMI decrease with betahistine augmentation as compared to placebo augmentation.~B. Betahistine augmentation in AP treated patients will increase levels of satiety in a standardized meal situation and decrease caloric intake as compared to placebo augmentation.~C. Metabolic effects of betahistine augmentation in AP treated patients will be reflected in differences in waist circumference, hip circumference and waist hip ratios D. Betahistine augmentation in this population will lead to decrease in fasting glucose-lipid lab values related to the development of metabolic syndrome as compared to placebo augmentation", - "NCTID": "NCT00709202" - }, - { - "brief_title": "The Influence of Vitamin D on Atypical Antipsychotic-induced Weight Gain", - "phase": "", - "drugs": "['Blood Draw']", - "drugs_list": [ - "Blood Draw" - ], - "diseases": "['Schizophrenia', 'Metabolic Syndrome', 'Vitamin D Deficiency']", - "diseases_list": [ - "Schizophrenia", - "Metabolic Syndrome", - "Vitamin D Deficiency" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n \u2022 Men and women with a DSM-IV clinical diagnosis of Schizophrenia, Schizoaffective or Bipolar disorder \n\n 21 to 65 years of age; male and female \n\n A willingness and ability to provide signed informed consent \n\n The subject should have been on quetiapine 100 mg or more for more than 12 weeks. \n\n ", - "exclusion_criteria": ": \n\n Pregnant women \n\n Subjects considered at high suicide risk based on the MINI Suicidality Module (> 17 points) \n\n Unstable general medical condition or serious illness (e.g. death or hospitalization is anticipated within one year), poor kidney function or liver function (defined as laboratory values \u2265 three times the upper limit of the normal), and seizure disorders except for childhood seizure disorders \n\n Concurrent therapy with certain psychotropics is permitted, provided that the medication and dose have been stable for the past 90 days \n\n Patients on concomitant treatment with clozapine and olanzapine are not permitted. \n\n Patients on immunosuppressant medications or any orexigenic or anorexigenic drug \n\n Patients on concomitant treatment with amphetamines and/ or methylphenidate \n\n History of hypothyroidism or thyroxine therapy \n\n Patients with a known condition or undergoing therapeutic measures that affects weight, including but not limited to: eating disorder, type I diabetes, hyperthyroidism, thyroxine therapy, Topamax therapy, and infectious diseases, such as HIV, hepatitis B, and hepatitis C \n\n Active supplementation of vitamin D within the last 3 months", - "brief_summary": "Schizophrenia and bipolar disorders are major public health problems. The second generation anti-psychotic drugs have efficacy for both positive and negative symptoms and a favorable risk profile as far as movement disorders. However, these drugs are associated with clinically significant weight gain and metabolic effects. The underlying mechanisms of these side effects are unclear, however in our preliminary studies with schizophrenic patients on atypical anti-psychotic drugs, we found that weight gain and vitamin D deficiency was present in about 50% of this population. Given the considerable heterogeneity among the patients on atypical anti-psychotics and potential for weight gain in vitamin D-deficient states, we propose that patients with schizophrenia who gain weight on atypical antipsychotic medications are vitamin D-deficient. This hypothesis will be tested in patients with schizophrenia receiving second-generation anti-psychotic drugs for a minimum duration of 4 months. Specific Aim: We predict that the patients with schizophrenia, who gain weight with antipsychotic treatment, are vitamin D-deficient compared to the patients who do not gain weight. We will examine circulating levels of serum 25(OH)D, mRNA transcripts and protein expression of vitamin D receptor (VDR) and the enzymes, CYP24A and CYP27B, in the white blood cells of the subjects and correlate with BMI and the blood levels of leptin and adiponectin.", - "NCTID": "NCT02281162" - }, - { - "brief_title": "Prevention of Weight Gain and Dyslipidemia by Green Tea in Patients Initiating Therapy With Olanzapine", - "phase": "", - "drugs": "['Green Tea', 'Placebo']", - "drugs_list": [ - "Green Tea", - "Placebo" - ], - "diseases": "['Bipolar Disorder', 'Schizophrenia']", - "diseases_list": [ - "Bipolar Disorder", - "Schizophrenia" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Concurrently taking Zyprexa\u00ae for a psychiatric indication such as bipolar disorder or schizophrenia \n\n Stable body weight (+ 5%) for at least 2 weeks prior to baseline visit \n\n No weight loss program participation within past 3 months \n\n ", - "exclusion_criteria": ": \n\n Treatment with an atypical Anti-psychotic treatment other than olanzapine with the past 6 months \n\n BMI > 40 kg/m2 \n\n Use of any dietary supplements related to weight gain or weight loss within past 1 month \n\n Use of any medication related to weight or plasma lipid concentration (other than hormonal contraceptives). This includes, but not limited to: antihypertensives, benzodiazepines statins, and psychostimulants. \n\n Uncontrolled hypertension (SBP >140 or DBP > 90 mmHg) \n\n Use of a hypertensive medication \n\n Known active alcohol or substance abuse or consumption of > three alcoholic beverages/day. \n\n Active cardiovascular disease", - "brief_summary": "The purpose of this study is to determine if taking green tea capsules can help prevent weight gain in patients that start therapy with Zyprexa\u00ae (olanzapine).", - "NCTID": "NCT00934908" - }, - { - "brief_title": "Facilitation of Zolpidem (\u226510 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia", - "phase": "Phase 4", - "drugs": "['Ramelteon and zolpidem', 'Placebo and zolpidem']", - "drugs_list": [ - "Ramelteon and zolpidem", - "Placebo and zolpidem" - ], - "diseases": "['Chronic Insomnia']", - "diseases_list": [ - "Chronic Insomnia" - ], - "enrollment": "135.0", - "inclusion_criteria": "inclusion criteria \n\n Chronic insomnia and taking greater than or equal to 10 mg zolpidem at least 4 times per week. \n\n Has been prescribed zolpidem for difficulty in initiating sleep. \n\n Must report chronic use of zolpidem greater than or equal to10 mg therapy for a minimum of 3 months prior to entry into Period 1 of the study. \n\n Must have taken zolpidem greater than or equal to 10 mg therapy for at least 4 of 7 days each week of the 4 weeks immediately prior to entry into the double blind phase, Period 2. \n\n Expressed a willingness to discontinue zolpidem therapy. \n\n Habitual bedtime is between 9:00 PM and 1:00 AM based on sleep history. \n\n Negative test result for hepatitis B surface antigen and hepatitis C virus antibody. \n\n Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. \n\n ", - "exclusion_criteria": " \n\n Known hypersensitivity to ramelteon, zolpidem, or melatonin. \n\n Participated in any other investigational study and/or taken any investigational drug within 30 days prior to the first dose of run-in study medication. \n\n Sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first night of run-in study medication. \n\n History of fibromyalgia, history of seizures, sleep apnea, restless leg syndrome, periodic leg syndrome, chronic obstructive pulmonary disease, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder. \n\n History of drug addiction or drug abuse within the past 12 months. \n\n History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition revised and/or regularly consumes more than 2 alcoholic drinks per day. \n\n Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first night of run-in study medication. \n\n Body mass index of less than 18 or greater than 34 (weight /height2). \n\n Any clinically important abnormal finding as documented by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator. \n\n Positive hepatitis panel. \n\n Known history of human immunodeficiency virus. \n\n Any additional conditions(s) that in the investigator's opinion would affect: \n\n sleep/wake function \n\n prohibit the subject from completing the study \n\n indicate that continuation in the study would not be in the best interests of the subject. \n\n Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including: \n\n Melatonin \n\n Anxiolytics \n\n Antipsychotics \n\n Over-the-counter and prescription sedatives \n\n Hypnotics (excluding zolpidem) \n\n Narcotic analgesics \n\n Antidepressants \n\n Beta-blockers (exception is that Atenolol is permissible) \n\n Anticonvulsants \n\n St. John's wort \n\n Sedating H1 antihistamines \n\n Kava-kava \n\n Systemic steroids \n\n Ginkgo-biloba \n\n Respiratory stimulants \n\n Over-the-counter and prescription diet aids \n\n Sedating Decongestants", - "brief_summary": "The purpose of this study is to assess whether ramelteon, once daily (QD), can facilitate the discontinuation of zolpidem in subjects with chronic insomnia.", - "NCTID": "NCT00492232" - }, - { - "brief_title": "Safety and Efficacy of Chronic Hypnotic Use", - "phase": "", - "drugs": "['zolpidem']", - "drugs_list": [ - "zolpidem" - ], - "diseases": "['Primary Insomnia']", - "diseases_list": [ - "Primary Insomnia" - ], - "enrollment": "116.0", - "inclusion_criteria": "inclusion criteria: \n\n age 21-70 yrs \n\n non-pregnant females who agree to standard birth control for 12 months and males \n\n two of the following chronic insomnia complaints: >30 min sleep latency, < 6 hrs sleep, or nonrestorative sleep. \n\n meet DSM-IV criteria for primary insomnia \n\n ", - "exclusion_criteria": ": \n\n any acute or unstable illness: conditions making it unsafe for the subject to participate, conditions with a potential to disturb sleep (i.e. acute pain, respiratory infection), and conditions which could interact with the pharmacokinetics or pharmacodynamics of zolpidem. \n\n chronic illnesses: renal failure, liver disease, seizures, and dementing illnesses. \n\n current psychiatric diseases: alcohol or substance abuse, depression, and schizophrenia. \n\n a history of alcohol or substance abuse within the past two years. \n\n a prestudy positive urine drug screen \n\n consuming >14 standard (1oz) alcoholic drinks per week \n\n caffeine consumption >300 mg/day \n\n smoking during the night (11pm-7am). \n\n medications including: anxiolytics, hypnotics. both prescription and OTC, (except in the chronic zolpidem group), antidepressants, anticonvulsants, sedating H1 antihistamines (non-sedating second generation H1 antihistamines are allowed), systemic steroids, respiratory stimulants and decongestants, prescription and OTC stimulants, prescription and OTC diet aids, herbal preparations, and narcotic analgesics. All medications and doses will be documented. \n\n sleep disordered breathing (SDB) defined as >10 apnea-hypopneas events per hour of sleep time or any other primary sleep (e.g., restless legs syndrome) or circadian disorder.", - "brief_summary": "The purpose of the study is to determine how safe and effective it is for people with insomnia to use zolpidem on a nightly basis for one year.", - "NCTID": "NCT01006525" - }, - { - "brief_title": "Alternative Dosing Regimens in the Pharmacotherapy of Insomnia", - "phase": "Phase 3", - "drugs": "['Amitriptyline', 'Zolpidem', 'Amitriptyline', 'Placebo']", - "drugs_list": [ - "Amitriptyline", - "Zolpidem", - "Amitriptyline", - "Placebo" - ], - "diseases": "['Insomnia']", - "diseases_list": [ - "Insomnia" - ], - "enrollment": "23.0", - "inclusion_criteria": "inclusion criteria: \n\n age between 18 years to 69 years \n\n fluent in German language \n\n provide written informed consent \n\n ability to understand the explanations and instructions given by the study physician and the investigator \n\n ", - "exclusion_criteria": ": \n\n Sleep disorders caused by medical factors (e.g. sleep apnea, restless legs syndrome, narcolepsy, substance-induced insomnia) \n\n Contraindications to study medication intake according to the information sheet for health professionals (Summary of medicinal Product Characteristics, SmPC; Fachinformation in Germany) assessed by physical examination (including ECG) and medical history \n\n allergies to amitriptyline hydrochloride or any of its ingredients \n\n allergies to zolpidem or any of its ingredients \n\n acute intoxication with alcohol, analgetics, hypnotics or any other psychotropic drug \n\n urinary retention \n\n delirium \n\n untreated closed-angle glaucoma \n\n prostatic hyperplasia \n\n pyloric stenosis \n\n paralytic ilius \n\n suicidal thoughts \n\n liver/ kidney/ pulmonary insufficiency \n\n myasthenia gravis \n\n hypokalemia \n\n bradycardia \n\n coronary heart disease, cardiac arrhythmias, long QT syndrome or other clinically relevant cardiac disorders \n\n increased risk of seizures/ history of seizures \n\n substance dependence syndrome/ history of substance dependence syndrome \n\n Allergies to ingredients of placebo or novel-tasting drink (CS) \n\n currently pregnant (verified by urine pregnancy test) or lactating \n\n patients scoring \u226512 on the Epworth Sleepiness Scale \n\n patients scoring below 8 or above 21 on the Insomnia Severity Index \n\n patients suffering from a mental disorder as verified by the SCID (major depression; psychosis; brain injury; substance abuse or dependency syndrome during the last 6 months before V1) \n\n nicotine consumption > 10 cigarettes/day \n\n unwillingness to refrain from alcohol consumption throughout the study \n\n Concomitant medication interfering with study medication intake due to potential interactions (all psychotropic medication including analgetics and muscle relaxants, hypericum derivatives; antihypertensives; anti-arrhythmic agents; antibiotics; cisaprid; anti-malaria drugs; diuretics; imidazole antifungals; cumarin derivatives; antihistaminics; calcium channel blockers; medications that enlarge the QT interval or may lead to hypokalemia) \n\n change in concomitant medication regime during the last 2 weeks prior to visit 1 or after randomization \n\n intake of psychotropic medication during the last 3 months \n\n participation in any other clinical trial 3 months prior to visit 1 \n\n women of childbearing age not using 2 highly effective contraceptive methods \n\n employee of the Sponsor or the principal investigator", - "brief_summary": "The purpose of this study is to evaluate whether drug efficiency of zolpidem and amitriptyline can be conditioned according to learning theory in patients with primary insomnia.", - "NCTID": "NCT02139098" - }, - { - "brief_title": "The Role of Partial Reinforcement in the Long Term Management of Insomnia", - "phase": "", - "drugs": "['Zolpidem', 'Placebos']", - "drugs_list": [ - "Zolpidem", - "Placebos" - ], - "diseases": "['Primary Insomnia']", - "diseases_list": [ - "Primary Insomnia" - ], - "enrollment": "129.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with insomnia will meet RDC criteria for psychophysiologic insomnia(99). These criteria are provided in Appendix 2. In addition, the complaint of disturbed sleep will have one or more of the following characteristics: \n\n > 30 minutes to fall asleep (Initial Insomnia) \n\n 2 awakenings per night of >15 minutes duration and/or wake after sleep onset time of > 30 minutes (Middle Insomnia) \n\n An awakening of > 30 minutes prior to the desired wake up time (Late Insomnia) \n\n Any two of the above complaints (Mixed Insomnia) \n\n Additionally, total sleep time will not exceed 6 hours (unless the sleep efficiency quotient is < 80%) and the problem frequency must be equal to or greater than 4 nights/ week (severe insomnia) with a problem duration > 6 months (chronic insomnia). This profile must be evident at both intake (based on retrospective reports) and as an average profile from the two weeks of baseline diaries (based on prospective sampling). \n\n ", - "exclusion_criteria": ": \n\n Unstable medical or psychiatric illness Assessed with the Mini International Neuropsychiatric Interview (MINI) and the The Schedule for Affective Disorders and Schizophrenia-Lifetime Version (SADS-L) To assure that the insomnia is not secondary to these factors \n\n Symptoms suggestive of sleep disorders other than insomnia Assessed with the SDS-CL To assure that the insomnia is not secondary to these factors \n\n Polysomnographic data indicating sleep disorders other than insomnia Assessed with PSG in collaboration with our sleep medicine consultants To assure that the insomnia is not secondary to these factors \n\n History of head injury with a sustained loss of consciousness Assessed by self report during the Intake Interview To help assure that the EEG measures are unconfounded by brain damage \n\n Evidence of active illicit substance use or fitting criteria for alcohol abuse or dependence Assessed with a structured psychiatric interview schedule (the MINI) , written versions of clinical interview queries regarding alcohol use, abuse and dependence (the AUDIT and CAGE), the toxicology screen which is part of the clinical chemistries obtained during the screening physical. To assure that the insomnia is not secondary to these factors and to assure that substance use/abuse does not confound treatment. \n\n Use of CNS active medications, antidepressants, and hypnotics other than zolpidem Assessed by self report and from the toxicology screen which is part of the clinical chemistries obtained during the screening physical. To help assure that the clinical effects observed in this study are due to the study medication and schedule of reinforcement. \n\n Inadequate language comprehension Informally, assessed by the Clinical Research Coordinator during Intake Interview To assure the quality of self report data as all the measures are in English. \n\n Pregnancy Assessed by self report and from the clinical chemistries data obtained during the screening physical. Excluded so as to 1) prevent the fetus from exposure to the study medication (although it should be noted that the medication is considered FDA pregnancy category B) and 2) control for the biopsychosocial changes that occur with pregnancy and may alter the response to the study medication and schedule of reinforcement. \n\n No first-degree relatives with bipolar disorder or schizophrenia Assessed by self report and a structured psychiatric interview schedule (the SADs). Excluded to reduce risk for first onset during the study", - "brief_summary": "The lack of scientific attention devoted to the placebo effect as a phenomenon in its own right probably reflects the paucity of theoretical positions within which to organize the existing data and design new research. The proposed investigation 1) is an attempt to advance from a descriptive to an experimental analysis of the placebo effect, taking into account classical conditioning effects, and 2) examines the clinical implications of partial reinforcement as it is applied to the treatment of insomnia. Subjects with primary insomnia will be treated with zolpidem for a period of one month and then randomized to one of four groups for a period of 12 weeks: one receiving full dose zolpidem on a nightly basis (continuous reinforcement), one receiving full dose zolpidem on 14 of 28 nights where placebo is provided on non-drug nights (partial reinforcement), one receiving full dose zolpidem on 14 of 28 nights where no pills are imbibed on non-drug nights (intermittent dosing), and one receiving 5 mg dose zolpidem on a nightly basis (continuous reinforcement with half the standard dose). Following treatment, subjects will be entered into an extinction protocol during which they will 1) continue on the schedule assigned during the experimental period, 2) receive only placebo, or 3) receive neither drug nor placebo. Sleep and daily functioning will be monitored on a daily basis via sleep diaries for the duration of the study. It is hypothesized that, holding cumulative dose constant, a partial schedule of reinforcement will enable patients to better maintain their clinical gains as compared to subjects that receive either continuous reinforcement with half the standard dose or half the frequency of use.~Relevance: The proposed research is not an attempt to offer a behavioral alternative to drug treatment; it is an attempt to acknowledge and capitalize on a behavioral dimension in the design of drug treatment protocols. The value of the proposed research resides in its capacity to provide for the long term treatment of insomnia in a manner that increases the durability of pharmacotherapy while reducing the overall amount of medication required. If proven effective in the current application, this new approach to pharmacotherapy and placebo effects is likely to stimulate new interdisciplinary research for the treatment of a variety of chronic diseases.", - "NCTID": "NCT00662155" - }, - { - "brief_title": "Lithium Cannabis Withdrawal Study", - "phase": "Phase 2", - "drugs": "['Lithium carbonate']", - "drugs_list": [ - "Lithium carbonate" - ], - "diseases": "['Cannabis Dependence', 'Substance Withdrawal Syndrome']", - "diseases_list": [ - "Cannabis Dependence", - "Substance Withdrawal Syndrome" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n DSM-IV diagnosis of cannabis dependence with at least a three-month history. \n\n Seeking treatment for primary cannabis problem \n\n Withdrawal identified as barrier to abstinence \n\n ", - "exclusion_criteria": ": \n\n Other drug dependency (excluding nicotine) \n\n Client is breastfeeding or pregnant. \n\n Client has contraindicated medical or psychiatric conditions. \n\n Client currently taking other medications that may interact with lithium. \n\n Known hypersensitivity / side effects with Lithium. \n\n Currently receiving Lithium from another source. \n\n Currently prescribed any antidepressant / mood stabilising / antipsychotic medication. \n\n Currently receiving opioid pharmacotherapy.", - "brief_summary": "This trial will examine the efficacy of lithium in providing symptomatic relief from the withdrawal discomfort experienced by some dependent users of cannabis on cessation of regular use. Significant withdrawal may be a barrier to achieving abstinence in some clients and can be associated with marked disturbances in mood, sleep, hostility and aggression. Relief from such symptoms may be important in helping some clients achieve a period of abstinence and facilitate subsequent entry into a relapse prevention program.", - "NCTID": "NCT00114439" - }, - { - "brief_title": "A Comparison of Midazolam and Zolpidem as Oral Premedication in Children", - "phase": "Phase 3", - "drugs": "['zolpidem', 'Midazolam']", - "drugs_list": [ - "zolpidem", - "Midazolam" - ], - "diseases": "['Parental/Caregiver Anxiety', \"Child's Anxiety\"]", - "diseases_list": [ - "Parental/Caregiver Anxiety", - "Child's Anxiety" - ], - "enrollment": "86.0", - "inclusion_criteria": "inclusion criteria: \n\n Pediatric patients ages 2-9 years \n\n ASA class I-II \n\n inpatient surgeries of at least 2 hours duration \n\n requiring postoperative admission of at least 23 hours ", - "exclusion_criteria": ": \n\n ", - "brief_summary": "The purpose of this investigator-initiated study is to compare the efficacy of oral midazolam and zolpidem for preoperative sedation, anxiety of patient, and caregiver anxiety at the time of separation, and ease of mask acceptance at induction in children. Subjects will be randomized to receive oral medication midazolam or zolpidem approximately 30 minutes prior to surgery. No placebo will be administered in this study. Subjects will be male and female children between 2 and 9 years of age. In total, subject participation will last approximately the duration of their preoperative, perioperative, and immediate postoperative period. A member of the research team will recruit subjects preoperatively in the operating room holding area prior to surgery. Consent will take place at the time of recruitment in the preoperative holding area following a detailed explanation of the study and medications involved in the study. Participants will be of ASA (American Society of Anesthesiologists) class I-II, undergoing surgical procedures of at least 2 hours duration, and expected to remain inpatient for at least 23 hours postoperatively.", - "NCTID": "NCT02096900" - }, - { - "brief_title": "Aripiprazole as Augmentation for TRD", - "phase": "Phase 2", - "drugs": "['Drug Abilify']", - "drugs_list": [ - "Drug Abilify" - ], - "diseases": "['Depression']", - "diseases_list": [ - "Depression" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n inclusion criteria: males or females age 18 to 65 years, DSM-IV episode of Major Depression non-psychotic, \u226514 score on the 17-item HRSD, adequate trial with two antidepressants (see definition above of 'adequate trial'), ability to receive and give informed consent, if patients are of child-bearing potential (male or female), use of an effective contraceptive is required for at least one month prior to the screening Visit and documentation of a negative pregnancy (female) test upon entry into the study. \n\n ", - "exclusion_criteria": ": \n\n ", - "brief_summary": "A sizeable minority of patients suffering from major depression do not have their full set of depressive symptoms relieved by a single medication. Often times, a second medication is added to a patient's first antidepressant to obtain a better response in hopes of getting the depressed patient into full remission from symptoms.~A typical psychiatric approach of recent has been to add one of the newer anti-schizophrenia medications to an existing FDA approved antidepressant in order to achieve better serotonin levels in the depressed patient's brain. This optimization of brain serotonin helps to alleviate more depressive symptoms. The newest antipsychotic medication to be FDA approved is Aripiprazole (Abilify). It may be particularly effective as it may safely elevate sertotonin through receptor 1a stimulation, receptor 2a blockade. It may also facilitate low levels of dopamine transmission which is truly novel for this agent when compared to other schizophrenia drugs. Depressed patients also tend to lack dopamine in their brains. This makes Aripiprazole and ideal agent to boost both serotonin and dopamine simultaneously. In theory, this may be an effective way to alleviate more depressive symptoms.~The author suggests to enroll 10 subjects initially in open label fashion to take Aripiprazole plus their current FDA approved antidepressant to see if further elimination of depressive symptoms occurs and to show this pharmacological approach as a tolerable combination of medications. If there are no major safety issues, an amendment to allow 10 additional subjects will be forwarded to provide a better tolerability sample size.", - "NCTID": "NCT00174876" - }, - { - "brief_title": "The Effectiveness of Interactive Discussion Group Intervention About Suicide Risk Identification and Assessment for Clinical Nurses", - "phase": "", - "drugs": "['Interactive discussion group']", - "drugs_list": [ - "Interactive discussion group" - ], - "diseases": "['Suicide Risk Assessment']", - "diseases_list": [ - "Suicide Risk Assessment" - ], - "enrollment": "111.0", - "inclusion_criteria": "inclusion criteria: \n\n nurses who work in a variety of wards such as Hematology, Oncology, Stroke and Rehabilitation where potential cases with high suicide risk may be identified.", - "exclusion_criteria": "", - "brief_summary": "Suicide attempters or people with self-harm have a high percentage in seeking medical services before and after their suicidal or self-harm behaviour compared to general population. Studies revealed that apart from psychiatric services, they were more likely to seek help from doctors of various units (e.g. emergency departments, general medicine, medical-surgical units) across different healthcare systems (i.e. hospitals or district clinics). Besides, suicide event was possibly heard on in-patients of psychiatric or non-psychiatric units. People with self-harm experienced poor communication with healthcare personnel, and they perceived staff's lacking knowledge about suicide as serious problems. In Taiwan it was also found that emergency nurses and general practitioners were in need of improving negative attitudes and enhancing knowledge towards suicidal behaviour. From the point that nurses are the healthcare personnel that spend the most time with in-patients compared to others in the hospital, suicide risk assessment training may enhance nurses' attitudes and ability of risk awareness and assessment towards people with self-harm, which may in turn significantly increase the identification rate of the high risk group for suicide. Currently there is a lack of suicide training program as a reference for nursing education in Taiwan. The study therefore aims to strengthen suicide risk assessment ability among clinical nurses through interactive discussion groups. Using quasi-experimental design with randomized cluster sampling strategy, a case vignettes will be used for suicide risk assessment together with other measurements regarding suicide knowledge and attitudes for both experiment and control groups before and after the training course.", - "NCTID": "NCT02033915" - }, - { - "brief_title": "Effect of Lithium and Divalproex in Alzheimer's Disease", - "phase": "Phase 2", - "drugs": "['Divalproex', 'Lithium']", - "drugs_list": [ - "Divalproex", - "Lithium" - ], - "diseases": "['Alzheimer Disease']", - "diseases_list": [ - "Alzheimer Disease" - ], - "enrollment": "35.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient is between the ages of 40 and 90 (inclusive). \n\n Patient will have a diagnosis of AD; the study will be confined to patients who are able to provide consent (pass a capacity assessment). \n\n The modified Hachinski Ischemia Score must be less than 4. \n\n Brain MRI performed within 15 months of enrollment must be compatible with the diagnosis of AD. \n\n Patient and/or caregiver are willing to adhere to protocol requirements as evidenced by written, informed consent. \n\n ", - "exclusion_criteria": ": \n\n Patients meeting any of the following ", - "brief_summary": "This study will examine the effect of the drugs lithium and divalproex (Depakote) on tau proteins, a type of protein in the brain and spinal fluid that are altered in patients with Alzheimer's disease. Both drugs are approved by the Food and Drug Administration to treat mood disorders, and both have been shown in animal studies to decrease the amount of altered tau protein. This study will determine whether lithium alone or in combination with divalproex reduces the altered tau protein in the spinal fluid of patients with Alzheimer's disease.~Patients with Alzheimer's disease who are between 40 and 90 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, neurologic and neuropsychological evaluation, blood and urine tests, electrocardiogram (EKG), and, if needed, a magnetic resonance imaging (MRI) scan of the brain.~Participants undergo the following tests and procedures:~Drug treatment: Patients take study drugs for 6 weeks.~Weekly clinic visits: Patients come to the clinic once a week for a physical examination, blood and urine tests, a review of drug side effects, and to receive the next week's supply of medications.~Lumbar puncture (spinal tap): Patients have a lumbar puncture at study weeks 2, 4, and 6 to measure various brain chemicals and tau proteins in the cerebrospinal fluid (CSF), which bathes the brain and spinal cord. For this test, a local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the CSF circulates below the spinal cord. A small amount of fluid is collected through the needle.~Follow-up visit: Two weeks after completing the study medication, patients return to the clinic for a final evaluation, including a physical examination and blood and urine tests.", - "NCTID": "NCT00088387" - }, - { - "brief_title": "Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.", - "phase": "Phase 2", - "drugs": "['zolpidem tartrate', 'sodium oxybate', 'Matching Placebos']", - "drugs_list": [ - "zolpidem tartrate", - "sodium oxybate", - "Matching Placebos" - ], - "diseases": "['Sleep Initiation and Maintenance Disorders']", - "diseases_list": [ - "Sleep Initiation and Maintenance Disorders" - ], - "enrollment": "48.0", - "inclusion_criteria": "inclusion criteria: \n\n Written informed consent is obtained. \n\n The patient is an outpatient, man or woman of any ethnic origin, 18-75 years of age (inclusive). \n\n Patient reports insomnia for at least six months, and insomnia causes the patient distress. \n\n The Investigator determines that the patient meets diagnostic criteria for Chronic Insomnia according to International Classification of Sleep Disorders (ICSD) criteria. \n\n Sleep diary based screening shows sleep onset latency >30 minutes, and /or wake after sleep onset >30 minutes per night at least 3 nights per week, with combined wake-time-in-bed _> 45 minutes. \n\n The patient is in good health as determined by a medical and psychiatric history, and physical examination. \n\n Women must be surgically sterile, 2 years post-menopausal, or if of child-bearing potential, using a medically accepted method of birth control, and agree to continued use of this method for the duration of the study. \n\n The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol. \n\n ", - "exclusion_criteria": ": \n\n Has any clinically significant, uncontrolled medical or psychiatric conditions. (treated or untreated) \n\n Has a probable diagnosis of a current sleep disorder other than Chronic Insomnia. \n\n Used any prescription drugs disallowed by the protocol or clinically significant use of over-the counter(OTC) drugs within 14 days before the screening visit. \n\n Has a history of alcohol, narcotic, or any other abuse as defined by the DSM-V. \n\n Has a clinically significant deviation from normal in the physical examination. \n\n Is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.) \n\n Has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery and succinic semialdehyde dehydrogenase deficiency) \n\n Has a known clinically significant drug sensitivity to sodium oxybate or sedative hypnotics.", - "brief_summary": "The primary purpose of the study is to evaluate the long term efficacy of sodium oxybate (Xyrem\u00ae) and zolpidem tartrate (Ambien\u00ae) in treating chronic insomnia. We will compare the efficacy of sodium oxybate with zolpidem tartrate (Ambien\u00ae), and compare the efficacy of each of these two medications with placebos.", - "NCTID": "NCT00383643" - }, - { - "brief_title": "Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers", - "phase": "Phase 1", - "drugs": "['placebo', 'zolpidem', 'zolpidem']", - "drugs_list": [ - "placebo", - "zolpidem", - "zolpidem" - ], - "diseases": "['Methodology Study']", - "diseases_list": [ - "Methodology Study" - ], - "enrollment": "11.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18-55 \n\n BMI 18-30 kg/m2 \n\n body weight > 50 kg \n\n ", - "exclusion_criteria": ": \n\n no history of sleep disorder \n\n no concurrent medications \n\n no alcohol use \n\n no medical issues \n\n no smoking", - "brief_summary": "This study will assess the feasibility of conducting sleep studies in a clinical research unit environment. In addition, the sensitivity of polysomnography and mobile actigraphy technologies will be compared for evaluating sleep stages and sleep architecture.", - "NCTID": "NCT00716521" - }, - { - "brief_title": "Promoting Healthy Weight Gain During Pregnancy", - "phase": "Phase 3", - "drugs": "['Lifestyle']", - "drugs_list": [ - "Lifestyle" - ], - "diseases": "['Weight Gain']", - "diseases_list": [ - "Weight Gain" - ], - "enrollment": "401.0", - "inclusion_criteria": "inclusion criteria: \n\n non-smoking, adults, \n\n < 16 weeks gestation \n\n ", - "exclusion_criteria": ": \n\n medical comorbidities", - "brief_summary": "Study goal is to determine whether behavioral lifestyle intervention during pregnancy can reduce the number of women who exceed the Institute of Medicine recommendations for weight gain during pregnancy.~It is hypothesized that the intervention will reduce the number of women who exceed weight gain guidelines relative to standard care. The investigators also expect the intervention to reduce the proportion of women exceeding weight gain guidelines in both normal weight and overweight groups.", - "NCTID": "NCT01117961" - }, - { - "brief_title": "The Immunogenicity and Safety of 2012-2013 Trivalent Seasonal Influenza Vaccine", - "phase": "Phase 4", - "drugs": "['2012-2013 trivalent seasonal influenza vaccine']", - "drugs_list": [ - "2012-2013 trivalent seasonal influenza vaccine" - ], - "diseases": "['Influenza']", - "diseases_list": [ - "Influenza" - ], - "enrollment": "202.0", - "inclusion_criteria": "For adults and old people: \n\n inclusion criteria: \n\n Healthy adults aged 18-60 years old, and healthy old people aged >60 years \n\n Be able to show legal identity card for the sake of recruitment Without vaccination history of seasonal split influenza vaccine in the recent 3 years \n\n Not participate in any other clinical trials during the study \n\n Not receive any immunosuppressive agents during and one month prior to the study \n\n Be able to understand and sign the informed consent. \n\n ", - "exclusion_criteria": ": \n\n Woman\uff1a Who breast-feeding or planning to become pregnant during the study \n\n Any history of allergic reactions; was allergic to any component of the vaccine, such as eggs or ovalbumin \n\n Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain \n\n Autoimmune disease or immunodeficiency \n\n Acute episode of chronic diseases or conditions, including chronic hepatitis, hypertension, diabetes mellitus and cardiovascular diseases \n\n Guillain-Barre Syndrome \n\n Women subjects with positive urinary pregnancy test \n\n Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis) \n\n Axillary temperature >37.0 centigrade at the time of dosing \n\n Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment \n\n Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent. \n\n For infants: \n\n inclusion criteria: \n\n Healthy male or female aged between 6 and 35 months \n\n Full-term birth, birth weight 2,500 grams or more \n\n provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent \n\n ", - "brief_summary": "The purpose of this study is to evaluate the immunogenicity and safety of 2012-2013 trivalent seasonal influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy older people aged > 60 years.", - "NCTID": "NCT01736709" - }, - { - "brief_title": "A Phase 1 Study To Estimate The Effects Of PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects", - "phase": "Phase 1", - "drugs": "['Lithium', 'PD 0332334', 'Lithium', 'PD 0332334']", - "drugs_list": [ - "Lithium", - "PD 0332334", - "Lithium", - "PD 0332334" - ], - "diseases": "['Generalized Anxiety Disease']", - "diseases_list": [ - "Generalized Anxiety Disease" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy males and/or females \n\n Age from 21 to 55 (inclusive) \n\n BMI ranges from 18 to 30 kg/m2 \n\n ", - "exclusion_criteria": ": \n\n Previous participation in a PD 332334 study \n\n Pregnant or nursing females \n\n Hypersensitivity (allergic) to lithium, Neurontin (gabapentin), or Lyrica (pregabalin)", - "brief_summary": "The purpose of this study is to investigate if PD 0332334 affects the pharmacokinetics of lithium by co-administering both drugs to healthy adults.", - "NCTID": "NCT00820794" - }, - { - "brief_title": "Bioequivalency Study of 300 mg Lithium Carbonate Under Fed Conditions", - "phase": "", - "drugs": "['Lithium']", - "drugs_list": [ - "Lithium" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. \n\n ", - "exclusion_criteria": ": \n\n Positive test for HIV, Hepatitis B, or Hepatitis C. \n\n Treatment with known enzyme altering drugs. \n\n History of allergic or adverse response to lithium, or any comparable or similar product.", - "brief_summary": "The objective of this study was the bioequivalence of a Roxane lithium carbonate 300 mg extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release tablet under fed conditions using a single-dose, randomized, 2 treatment, 2-period, 2-sequence crossover design.", - "NCTID": "NCT00602394" - }, - { - "brief_title": "Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions", - "phase": "", - "drugs": "['Lithium']", - "drugs_list": [ - "Lithium" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. \n\n ", - "exclusion_criteria": ": \n\n Participation in a clinicl trial within 30 days prior to study initiation. \n\n Positive test for HIV, Hepatitis B, or Hepatitis C. \n\n Treatment with known enzyme altering drugs.", - "brief_summary": "The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate 450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg extended release tablet under fed conditions using a single-dose, randomized, three-treatment, three-period, six-sequence crossover design.", - "NCTID": "NCT00601575" - }, - { - "brief_title": "Single Dose Pharmacokinetic and Pharmacodynamic Evaluation of Three Different Doses of Zolpidem in Children", - "phase": "Phase 1; Phase 2", - "drugs": "['Zolpidem']", - "drugs_list": [ - "Zolpidem" - ], - "diseases": "['Insomnia', 'Sleep Disorder']", - "diseases_list": [ - "Insomnia", - "Sleep Disorder" - ], - "enrollment": "63.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female between the ages of 2 years and 18 years. \n\n Written consent must be obtained form the parent/legal guardian for all minors. Written assent must be obtained from all minors > 6 years of age. \n\n Female subjects of child-bearing potential must not be pregnant and if females are fertile and sexually active, must have documented a negative urine HCG and assure use of effective contraception acceptable to the investigator (abstinence accepted) during the study period. \n\n Subjects must meet the following criteria for a diagnosis of insomnia as determined by the subject's private physician or study investigator and subject's history: \n\n the complaint is significant difficulty (defined by frequency, severity, and/or chronicity) initiating or maintaining sleep;. The problem is viewed problematic by the child and/or caregiver; \n\n the sleep disturbance causes clinically significant impairment in school performance, behavior, learning, or development for the child as reported by the child and/or caregiver; \n\n the sleep disturbance does not occur exclusively in the context of an intrinsic dyssomnia such as narcolepsy, restless legs syndrome, or sleep-related breathing disorders; a circadian rhythm disorder; or a parasomnia; \n\n the sleep disturbance is not attributable to either the direct physiologic effect of a drug of abuse or misuse of a prescribed medication. \n\n ", - "exclusion_criteria": ": \n\n Pregnancy and/or breastfeeding; \n\n The presence of any untreated (where treatment is available), or unstable, progressive, or evolving clinically significant renal, endocrine, hepatic, respiratory, cardiovascular, neurologic, hematologic, immunologic, cerebrovascular disease or malignancy; \n\n Elevations in screening blood tests of renal (SCr) and liver (ALT, AST and/or bilirubin) > 2 times the upper limit of normal for age. \n\n Receiving any medications that may modulate Zolpidem metabolism, primarily drugs that will enhance or reduce the activity of CYP450 3A, 2C9, or 2D6 activity. Note: If patient is receiving a medication that might be considered an inducer or an inhibitor, please discuss with the PI prior to excluding them. \n\n Receiving any medications with sleep-impairing properties at a dose/dose interval that would be judged by the study investigator as to interfere with the assessment of Zolpidem sleep response. \n\n Currently using any systemic contraceptive steroids including: oral contraceptives, transdermal patch, vaginal insert, levonorgestrel implant and medroxyprogesterone acetate contraceptive injection.", - "brief_summary": "This is a multicenter trial to evaluate the single-dose safety, tolerability and pharmacokinetics-pharmacodynamics of Zolpidem in a group of children with sleep disturbances stratified by age and dose.", - "NCTID": "NCT00494468" - }, - { - "brief_title": "Ph I Study of Lithium During Whole Brain Radiotherapy For Patients With Brain Metastases", - "phase": "Phase 1", - "drugs": "['lithium carbonate', 'cognitive assessment', 'quality-of-life assessment', 'radiation therapy']", - "drugs_list": [ - "lithium carbonate", - "cognitive assessment", - "quality-of-life assessment", - "radiation therapy" - ], - "diseases": "['Brain and Central Nervous System Tumors', 'Cognitive/Functional Effects', 'Neurotoxicity', 'Solid Tumor']", - "diseases_list": [ - "Brain and Central Nervous System Tumors", - "Cognitive/Functional Effects", - "Neurotoxicity", - "Solid Tumor" - ], - "enrollment": "9.0", - "inclusion_criteria": "inclusion criteria: \n\n Histopathologically confirmed extracranial primary malignancy \n\n Multiple (i.e., > 3) brain metastases OR < 3 metastases with at least 1 metastasis > 4.0 cm in diameter \n\n Not eligible for radiosurgery \n\n No requirement for immediate whole-brain radiotherapy \n\n No metastases to the midbrain or brainstem \n\n ", - "exclusion_criteria": ": \n\n Zubrod performance status 0-2 \n\n Life expectancy \u2265 8 weeks \n\n Platelet count > 100,000/mm^3 \n\n ANC > 1,500/mm^3 \n\n Hemoglobin \u2265 10 g/dL \n\n BUN < 25 mg/dL \n\n Creatinine < 1.5 mg/dL \n\n Bilirubin < 1.5 mg/dL \n\n ALT \u2264 2 times normal \n\n Sodium > 136 mg/dL \n\n Not pregnant or nursing \n\n Negative pregnancy test \n\n Fertile patients must use effective contraception \n\n Neurologically stable \n\n No seizure disorders or seizures due to brain metastases \n\n No medical illnesses or psychiatric conditions that would preclude completion of study treatment \n\n No sensory neuropathy \u2265 grade 2 \n\n No bipolar disorder \n\n No thyroid disease \n\n No QTc interval prolongation \n\n PRIOR CONCURRENT THERAPY: \n\n More than 2 weeks since prior and no concurrent chemotherapy \n\n At least 2 weeks since prior and no concurrent NSAIDs, angiotensin-converting enzyme inhibitors (e.g., enalapril or captopril), calcium channel blockers, diuretics, selective cyclooxygenase-2 inhibitors, acetazolamide, urea, xanthine, or alkalinizing agents (e.g., sodium bicarbonate) \n\n No prior radiotherapy to the head and neck area \n\n No prior radiosurgery \n\n No concurrent radiotherapy to other sites \n\n No concurrent anticonvulsants due to brain metastases \n\n No concurrent psychoactive drugs \n\n No concurrent thyroid medications \n\n No concurrent amifostine", - "brief_summary": "RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as lithium, may protect normal cells from the side effects of radiation therapy. Giving lithium together with radiation therapy may allow a higher dose of radiation therapy to be given so that more tumor cells are killed.~PURPOSE: This phase I trial is studying the side effects and best dose of lithium when given together with whole-brain radiation therapy in treating patients with brain metastases from primary cancer outside the brain.", - "NCTID": "NCT00469937" - }, - { - "brief_title": "Sleep and Endometrial Cancer", - "phase": "", - "drugs": "['zolpidem', 'sugar pill']", - "drugs_list": [ - "zolpidem", - "sugar pill" - ], - "diseases": "['Sleep', 'Endometrial Neoplasms', 'Pain']", - "diseases_list": [ - "Sleep", - "Endometrial Neoplasms", - "Pain" - ], - "enrollment": "6.0", - "inclusion_criteria": "inclusion criteria: \n\n be women at least 18 years old \n\n have clinical indications of primary endometrioid adenocarcinoma of the endometrium \n\n be scheduled for staging surgery by laparotomy under standardized protocols \n\n have the ability to communicate in English sufficient for completion of study materials \n\n have no neuromuscular/ movement disorders (for actigraphy purposes) \n\n have no uncontrolled medical, sleep, endocrine or psychiatric illness (as determined by their attending physician as part of clinical care) \n\n have no ongoing use of medication known to affect sleep or wake function (e.g., hypnotics, benzodiazepines, antidepressants, anxiolytics, antipsychotics, decongestants, sedating antihistamines, beta blockers, corticosteroids) \n\n ", - "exclusion_criteria": ": \n\n have a history of previous or concomitant cancer \n\n have an estimated life expectancy of < 6 months \n\n will be admitted to the hospital prior to the day of surgery \n\n are unable to complete study measures \n\n are unable to provide meaningful informed consent", - "brief_summary": "This study proposes to test the hypothesis that zolpidem taken the night before major surgery for endometrial cancer will improve sleep efficiency and reduce post surgery pain, as well as reduce the need for analgesic medication.", - "NCTID": "NCT00936598" - }, - { - "brief_title": "Efficacy and Safety of 5 mg Sublingual Zolpidem vs 10mg Oral Zolpidem in the Induction and Maintenance of Sleep in Patients With Primary Insomnia", - "phase": "Phase 4", - "drugs": "['Zolpidem Hemitartrate']", - "drugs_list": [ - "Zolpidem Hemitartrate" - ], - "diseases": "['Primary Insomnia']", - "diseases_list": [ - "Primary Insomnia" - ], - "enrollment": "67.0", - "inclusion_criteria": "inclusion criteria: \n\n Men or women aged between 20 and 64 years; \n\n Diagnosis of primary insomnia according to criteria defined by DSM-IV; \n\n Difficulty in maintaining sleep and waking up until 3 am; \n\n Not having used any psychoactive drug in the last 30 days prior to their inclusion in the study; \n\n Signature of IC. \n\n ", - "exclusion_criteria": ": \n\n Previous history of serious medical illness, neurological or psychiatric disorder; \n\n Allergy or hypersensitivity to zolpidem; \n\n Obstructive Sleep Apnea syndrome; \n\n Polysomnography with apnea and hypopnea index >10/hour or PLM >15/h; \n\n Other secondary sleep disorders; \n\n History of substance abuse or dependence; \n\n History of daily consumption of alcoholic beverages; \n\n Pregnancy, lactation or refusal to use safe contraceptive methods during the study.", - "brief_summary": "The purpose of this study is to evaluate the efficacy and safety of sublingual zolpidem presentation 5 mg in the induction of sleep in patients with primary insomnia.", - "NCTID": "NCT01896336" - }, - { - "brief_title": "Hypnotic Medications and Memory: Effect of Drug Exposure During the Night", - "phase": "Phase 4", - "drugs": "['zaleplon', 'zolpidem extended release', 'bedtime placebo', 'middle of the night placebo']", - "drugs_list": [ - "zaleplon", - "zolpidem extended release", - "bedtime placebo", - "middle of the night placebo" - ], - "diseases": "['Sleep', 'Memory']", - "diseases_list": [ - "Sleep", - "Memory" - ], - "enrollment": "26.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 to 50 years of age \n\n no sleep complaints or problems \n\n good sleep quality per questionnaire \n\n sufficient time in bed each night \n\n ", - "exclusion_criteria": ": \n\n any clinically significant unstable medical condition \n\n recent psychiatric disorder \n\n prior diagnosis or symptoms of a sleep disorder \n\n recent history of substance abuse \n\n recent use of prescription hypnotic medication or over-the-counter sleep aid \n\n recent use of psychotropic medication \n\n history of adverse reaction to benzodiazepines \n\n body mass index > 36 \n\n currently pregnant or nursing \n\n currently working rotating or night shift \n\n consumption of > 700 mg per day of xanthine-containing food or beverages \n\n consumption of > 14 units of alcohol per week \n\n smoke > 1 pack of cigarettes per day, use of chewing tobacco more than 3 times per day, or unable to refrain from smoking or chewing without distress or discomfort while in the sleep laboratory", - "brief_summary": "The purpose of this study is to determine the effect of two hypnotic medications, zolpidem extended release and zaleplon, on memory. It is expected that a hypnotic with shorter drug duration will allow greater memory consolidation than a hypnotic with longer drug duration.", - "NCTID": "NCT01159652" - }, - { - "brief_title": "Positron Emission Tomography Assessment of the Central Nervous System Effects of Eszopiclone and Zolpidem", - "phase": "Phase 4", - "drugs": "['eszopiclone, zolpidem, placebo']", - "drugs_list": [ - "eszopiclone", - "zolpidem", - "placebo" - ], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy Males age 18 to 35 inclusive \n\n Body Mass Index 18 to 30 \n\n Willing to adhere to prohibitions and restrictions specified in protocol \n\n Must give informed consent. \n\n ", - "exclusion_criteria": ": \n\n Clinically significant abnormal lab values for chemistry, hematology or urinalysis at screening. \n\n Clinically significant abnormal physical exam, vital signs, or 12-lead EKG at screening \n\n Significant history of or current significant medical illness. \n\n Significant history of or current psychiatric or neurological illness or sleep apnea. \n\n Participation in another research study involving exposure to ionizing radiation within the last 12 months. \n\n Any clinically significant MR abnormality which may be relevant to the study. \n\n Metal implants which are relevant for MR or PET procedures or data. \n\n History of epilepsy or fits or unexplained blackouts. \n\n Serology positive for Hepatitis B surface antigen, Hepatitis C antibodies, or HIV antibodies. \n\n Positive urine screen for drugs of abuse. \n\n Positive alcohol screen. \n\n Known or suspected alcoholism or drug addiction even if currently abstaining \n\n Drinks on average more than 8 cups of coffee, tea, cocoa, or cola per day. \n\n Smoking cigarettes within 3 months prior to study drug administration. \n\n Clinically significant acute illnes within 7 days of study drug administration. \n\n Claustrophobia. \n\n Donation of 1 or more units of blood (approximately 450ml), or acute loss of an equivalent amount of blood within 90 days prior to study drug administration. \n\n Have received an experimental drug or used an experimental medical device within 90 days of planned start of treatment with drugs for this study. \n\n Use of any prescription or over the counter medication, or herbal medication (not including non-steroidal anti-inflammatory drugs) within 2 weeks of the first PET scan. Of particular concern would be GABA-ergic compounds and CYP3A4 inhibitors. Exclusion should also be considered if the subject has taken a drug with a long half-life (or of any metabolite) even if taken outside the two week time window. However, the subject can still be enrolled if, in the opinion of the investigator, such medication taken in that timeframe will not interfere with the results of the study. \n\n Psychological or emotional problems that would render the informed consent invalid or limit the ability of the subject to comply with the study requirements. \n\n Any condition that in the opinion of the investigator would complicate or compromise the study, or the well-being of the subject.", - "brief_summary": "This study will compare the interactions of a placebo and two FDA-approved sleeping medications, Eszopiclone (Lunesta) and Zolpidem (Ambien), with certain chemical receptors in the brain. We want to show that we can use positron emission tomography images to measure the binding of these medications to the receptors.", - "NCTID": "NCT00781482" - }, - { - "brief_title": "Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien\u00ae Under Fasting Conditions", - "phase": "Phase 1", - "drugs": "['Zolpidem Tartrate 10 mg tablet', 'Zolpidem Tartrate 10 mg tablet (Ambien\u00ae)']", - "drugs_list": [ - "Zolpidem Tartrate 10 mg tablet", - "Zolpidem Tartrate 10 mg tablet (Ambien\u00ae)" - ], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "38.0", - "inclusion_criteria": "inclusion criteria: \n\n Sex: Male or Female; similar proportions of each preferred \n\n Age: At least 18 years \n\n Weight: must be 15% of ideal weight for height and frame \n\n Subjects must be in good health and physical condition as determined by medical history \n\n Subjects must read and sign the Consent Form \n\n ", - "exclusion_criteria": ": \n\n History of treatment for alcoholism, substance abuse, or drug abuse within past 24 months. \n\n History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness. \n\n History of GERD, malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease. \n\n History of treatment for asthma within the past five (5) years. \n\n History of mental depression. \n\n History of pulmonary disease. \n\n History of sleep apnea. \n\n Females who are pregnant or lactating. \n\n History of hypersensitivity to zolpidem tartrate, or any hypnotic or sedative. \n\n Treatment with any other investigational drug during the four weeks prior to the initial dosing of the study. \n\n Donation of blood within four weeks prior to the initial dosing of the study \n\n Smokers or subjects who use tobacco/nicotine products. Three months abstinence is required.", - "brief_summary": "The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available reference drug product Ambien\u00ae (zolpidem tartrate tablets) in adult subjects under fasted conditions.", - "NCTID": "NCT00684814" - }, - { - "brief_title": "Lithium for Low-Grade Neuroendocrine Tumors", - "phase": "Phase 2", - "drugs": "['Lithium Carbonate']", - "drugs_list": [ - "Lithium Carbonate" - ], - "diseases": "['Neuroendocrine Tumors']", - "diseases_list": [ - "Neuroendocrine Tumors" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria: \n\n Must have histologically confirmed metastatic low-grade neuroendocrine neoplasms. Small cell lung cancers, paragangliomas and pheochromocytomas are excluded. Pathologic diagnosis must be confirmed at the University of Wisconsin Carbone Cancer Center (UWCCC). Grading must be confirmed by pathologic review performed at UWCCC. \n\n Must have measurable disease \n\n Must have radiographic evidence of disease progression following any prior systemic therapy, chemoembolization, bland embolization, surgery, or observation. \n\n Must be \u2265 4 weeks from the completion of major surgery, chemotherapy, or other systemic therapy or local liver therapy to study registration \n\n Must be \u2265 3 weeks from the completion of radiation therapy to study registration \n\n The following laboratory values are to be obtained within 14 days prior to registration: Absolute neutrophils count (ANC) \u2265 1000/mm3; Platelets \u2265 75,000/mm3; Hemoglobin \u2265 8.0 g/dL; Total bilirubin less than or equal 2.0 X the upper limit of normal (ULN); AST less than or equal to 3 X ULN or less than or equal 5 X ULN if liver metastases are present; Creatinine less than or equal ULN; Serum sodium within normal limits \n\n PS = 0-2 \n\n Capable of understanding the investigational nature, potential risks and benefits fo the study and able to provide valid informed consent. \n\n Must have available tissue specimens to be analyzed for pathologic confirmation. \n\n Age \u2265 18 years. \n\n Women must not be pregnant or lactating. \n\n Women of childbearing potential and sexually active males are required to use an accepted and effective method of contraception. \n\n Patients must not have known history of allergic reactions or adverse reactions to Lithium or derivatives. \n\n Patients are not allowed to be on concurrent chemotherapy or radiation therapy. \n\n Patients are excluded if they have any of the following: \n\n Gastrointestinal tract disease resulting in an inability to take oral medication (i.e. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, bowel obstruction, or inability to swallow the tablets. \n\n History of hypothyroid disease Significant, active cardiac disease \n\n Patients must not be taking the following medications: diuretics, ACE inhibitors, NSAIDs (except aspirin or sulindac), neuroleptics, tetracycline, COX2 (cyclooxygenase-2) inhibitors, citalopram, clovoxamine, escitalopram, femoxetine, fluoxetine, fluvoxamine, paroxatine, sertraline, and zimeldine. \n\n Must be willing to undergo a tumor biopsy pre and post therapy. \n\n Patients with a concurrent malignancy are allowed on study as long as the patient is not undergoing active treatment for their disease. \n\n Patients already taking Lithium for any reason are not allowed on study.", - "exclusion_criteria": "", - "brief_summary": "The purpose of this study is to learn more about the effectiveness and side effects of lithium treatment for subjects with low-grade neuroendocrine tumors.", - "NCTID": "NCT00501540" - }, - { - "brief_title": "A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia", - "phase": "Phase 3", - "drugs": "['zolpidem tartrate sublingual tablet', 'Placebo']", - "drugs_list": [ - "zolpidem tartrate sublingual tablet", - "Placebo" - ], - "diseases": "['Insomnia']", - "diseases_list": [ - "Insomnia" - ], - "enrollment": "295.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults with history of sleeplessness \n\n ", - "exclusion_criteria": ": \n\n Allergic to investigational drug \n\n Any conditions and medications that may interfere with study drug evaluation", - "brief_summary": "The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.", - "NCTID": "NCT00466193" - }, - { - "brief_title": "Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien\u00ae Tablets", - "phase": "Phase 1", - "drugs": "['Zolpidem Tartrate 10 mg tablet', 'Zolpidem Tartrate 10 mg tablet (Ambien\u00ae)']", - "drugs_list": [ - "Zolpidem Tartrate 10 mg tablet", - "Zolpidem Tartrate 10 mg tablet (Ambien\u00ae)" - ], - "diseases": "['Healthy', 'Therapeutic Equivalency']", - "diseases_list": [ - "Healthy", - "Therapeutic Equivalency" - ], - "enrollment": "38.0", - "inclusion_criteria": "inclusion criteria: \n\n Sex: Male or Female; similar proportions of each preferred \n\n Age: At least 18 years \n\n Weight: must be 15% of ideal weight for height and frame \n\n Subjects must be in good health and physical condition as determined by medical history \n\n Subjects must read and sign the Consent Form \n\n ", - "exclusion_criteria": ": \n\n history of treatment for alcoholism, substance abuse, or drug abuse within past 24 months \n\n history of malignancy, stroke, diabetes, cardiac, renal or liver disease \n\n history of GERD, malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease \n\n history of treatment for asthma within the past five (5) years \n\n history of mental depression, pulmonary disease, sleep apnea \n\n females who are pregnant or lactating \n\n history of hypersensitivity to zolpidem tartrate, or any hypnotic or sedative \n\n conditions upon screening which might contraindicate or require that caution be used in the administration of zolpidem tartrate, including sitting systolic blood pressure below 90 mm Hg, or diastolic pressure below 50 mm Hg; heart rate less than 50 beats per minute after a 5-minute rest in a seated position \n\n inability to read and/or sign the consent form \n\n treatment with any other investigation drug during the four (4) weeks prior to the initial dosing for this study \n\n subjects who have donated blood within four (4) weeks prior to the initial dosing for this study \n\n subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums, etc.) Three (3) months abstinence is required.", - "brief_summary": "The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available Ambien\u00ae (zolpidem tartrate tablets)in adult subjects under fed conditions.", - "NCTID": "NCT00658541" - }, - { - "brief_title": "Lithium in Multiple System Atrophy", - "phase": "Phase 2", - "drugs": "['Lithium Carbonate', 'Placebo']", - "drugs_list": [ - "Lithium Carbonate", - "Placebo" - ], - "diseases": "['Multiple System Atrophy']", - "diseases_list": [ - "Multiple System Atrophy" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of probable MSA (Gilman, et al. 2008) \n\n Age \u226518, <80 \n\n ", - "exclusion_criteria": ": \n\n Heart failure \n\n Liver disease \n\n Kidney failure \n\n Thyroid disease \n\n Sick sinus syndrome and/or significant ECG alterations \n\n Hyposodemia \n\n Treatment with diuretics \n\n Treatment with haloperidol and/or other antipsychotics \n\n Treatment with NSAIDs or corticosteroids \n\n Treatment with ACE inhibitors \n\n Treatment with aminophyllines \n\n Treatment with mannitol \n\n Pregnancy and/or breastfeeding \n\n Acute diseases that might interfere with the trial", - "brief_summary": "The purpose of this study is to determine safety and tolerability of the treatment with lithium in Multiple System Atrophy. Moreover, clinical symptoms, neuronal loss, quality of life and depressive symptoms, will be considered to further investigate the effect of lithium therapy.", - "NCTID": "NCT00997672" - }, - { - "brief_title": "Safety and Tolerability of Lithium in Spinocerebellar Ataxia 2 (SCA2)", - "phase": "Phase 2", - "drugs": "['LITHIUM CARBONATE']", - "drugs_list": [ - "LITHIUM CARBONATE" - ], - "diseases": "['SPINOCEREBELLAR ATAXIA 2']", - "diseases_list": [ - "SPINOCEREBELLAR ATAXIA 2" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Molecular diagnosis of SCA2 (\u226534 CAG in the ataxin-2 gene) \n\n Age \u226518, <80 \n\n SARA score \u22658 \n\n ", - "exclusion_criteria": ": \n\n SARA score >32 \n\n Heart failure \n\n Liver disease \n\n Kidney failure \n\n Thyroid disease \n\n Sick sinus syndrome and/or significant ECG alterations \n\n Hyposodemia \n\n Treatment with diuretics \n\n Treatment with haloperidol and/or other antipsychotics \n\n Treatment with NSAIDs or corticosteroids \n\n Treatment with ACE inhibitors \n\n Treatment with aminophyllines \n\n Treatment with mannitol \n\n Pregnancy and/or breastfeeding \n\n Acute diseases that might interfere with the trial", - "brief_summary": "The purpose of this study is to determine safety and tolerability of the treatment with lithium in Spinocerebellar Ataxia 2. Moreover, clinical symptoms, neuronal loss, quality of life and depressive symptoms, will be considered to further investigate the effect of lithium therapy.", - "NCTID": "NCT00998634" - }, - { - "brief_title": "Efficacy and Safety of Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries", - "phase": "Phase 2", - "drugs": "['Lithium Carbonate', 'Placebo']", - "drugs_list": [ - "Lithium Carbonate", - "Placebo" - ], - "diseases": "['Spinal Cord Injury']", - "diseases_list": [ - "Spinal Cord Injury" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects of either gender and 18-60 years of age; \n\n Subjects with chromic spinal cord injury (defined as a history of spinal cord injury for 12 months or longer); \n\n Subjects with ASIA - classification of A, B, or C for at least 6 months unchanged; \n\n Spinal cord injury vertebral level should be between C4 and T10; \n\n Subjects must be able to read, understand, and complete the VAS; \n\n Subjects who have voluntarily signed and dated an informed consent form, approved by an IRB/IEC, prior to any study specific procedures. \n\n ", - "exclusion_criteria": ": \n\n A history of hypersensitivity or other adverse reaction to lithium; \n\n Significant renal, cardiovascular, hepatic and psychiatric disease; \n\n Significant medical diseases or infection; \n\n Addison's disease; \n\n Debilitation or dehydration; \n\n Recently taken or are taking diuretics or other drugs with known interaction with lithium, such as tricyclic antidepressants, NSAIDs and tetracyclines; \n\n A history of alcohol abuse or drug abuse; \n\n Pregnant or lactating women; \n\n Female of childbearing potential and are unwilling to use an effective contraceptive method while enrolled in the study; \n\n Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening of this study; \n\n Subjects who have taken lithium for manic depression or other psychiatric conditions,and finally; \n\n Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.", - "brief_summary": "This is a randomized, placebo-controlled, double-blinded trial. Forty patients will be randomized into two groups. The subjects in the Treatment Group will be administered with lithium carbonate, while the Control Group will receive placebo.~Each subject will receive oral lithium carbonate or placebo for six weeks. In the treatment group, the dose will be adjusted according to the serum lithium level while in the control group there will be a sham adjustment.~The outcomes will be assessed 6 weeks and 6 months after the onset of the medication. The outcomes will be compared with baseline pre-treatment data to obtain neurological change scores. The efficacy and safety will be analyzed comparing the results of the treatment group with those of the control group.", - "NCTID": "NCT00750061" - }, - { - "brief_title": "Pharmacokinetics of Zolpidem Orodispersible Tablet", - "phase": "Phase 1", - "drugs": "['Zolpidem Hemitartarate']", - "drugs_list": [ - "Zolpidem Hemitartarate" - ], - "diseases": "['Healthy Volunteers']", - "diseases_list": [ - "Healthy Volunteers" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female study participants, aged above 18 years-old; women cannot be pregnant or breastfeeding \n\n Body mass index (BMI) greater than or equal to 19 and less than or equal to 28.75 Kg/m2 \n\n Good health conditions or without significant diseases, according to best medical judgement, according to protocol requirements and study evaluations: medical history, blood pressure and heart rate measurements, physical examination, electrocardiogram (ECG) and complementary laboratory tests \n\n Ability to understand the nature and objectives of the trial, including risks and adverse events; willingness to cooperate with the researcher and proceed according to all study requirements, which shall be confirmed by Informed Consent Form signature. \n\n ", - "exclusion_criteria": ": \n\n Known hypersensitivity to the investigational product (Zolpidem) or chemically related compounds; history of serious adverse reactions or hypersensitivity to any drug \n\n History or presence of hepatic or gastrointestinal diseases, or other condition that interferes with drug absorption, distribution, excretion or metabolism \n\n Chronic therapy with any drugs, except oral contraceptives \n\n History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic or psychiatric disease; hypotension or hypertension, of any etiology, that requires pharmacological treatment; history of myocardial infarction, angina and/or heart failure \n\n Electrocardiographic findings that, at investigator criteria, are not recommended for study participation \n\n Deviations on screening laboratory results that are considered as clinically relevant by the researcher \n\n Smoking \n\n Intake of more that 5 cups of coffee or tea per day \n\n Unusual food habits, e.g., vegetarians \n\n History of drugs and alcohol addiction or excessive alcohol consumption (> 35 g/day) \n\n Use of regular medications within 2 weeks prior study enrollment or use of any medications within one week prior to study enrollment, except oral contraceptives or cases which, based on drug's or metabolite's half-life, complete elimination can be assumed \n\n Hospitalization for any reasons up to 8 weeks before trial \n\n Treatment, within 6 months before the trial, with any drugs with known and well-established toxic potential to major organs \n\n Participation in any other experimental research or administration of any experimental drug within 6 months before this trial \n\n Donation or loss of 450 mL or more of blood within 3 months before this trial or 3 donations (women)/4 donations (men) of blood within 12 months before this trial \n\n Any condition, according to investigator's best judgement, that prevents the subject to participate in the trial \n\n Pregnancy, labor or miscarriage with 12 weeks before admission predicted date.", - "brief_summary": "This is a Phase I, open-label, randomized trial to evaluate the single-dose pharmacokinetics of Zolpidem orodispersible tablet at two different dosages (1.75 mg and 3.50 mg). Sample size is 48 participants, male or female, aged above 18 years-old.~Primary objective is to evaluate pharmacokinetics of Zolpidem orodispersible tablet at two different dosages (1.75 mg and 3.50 mg), and secondary objective is to evaluate safety and tolerability of the investigational product.~Participants will be admitted for a period of 36 hours, when investigational product will be administered, and blood samples, at pre-determined time periods, will be collected for pharmacokinetics.~Primary endpoint is to obtain pharmacokinetics parameters. Additionally, safety will be assessed by adverse events occurrence and laboratory exams evaluation.", - "NCTID": "NCT02607696" - } - ], - "1": [ - { - "brief_title": "Treatment of Depression in Youth With Bipolar Disorders", - "phase": "Phase 3", - "drugs": "['Fluoxetine']", - "drugs_list": [ - "Fluoxetine" - ], - "diseases": "['Bipolar Disorder', 'Depression']", - "diseases_list": [ - "Bipolar Disorder", - "Depression" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n inclusion criteria: \n\n Free of manic symptoms for at least 4 weeks. Must be treated with valproate or lithium (mood stabilizers) for at least 4 weeks. Meet criteria for major depression and bipolar disorder (BP-I, BP-II, or BP-NOS). Not pregnant \n\n ", - "exclusion_criteria": ": \n\n ", - "brief_summary": "THIS STUDY HAS BEEN DISCONTINUED.~The study is designed to evaluate the safety and efficacy of fluoxetine for treating children and adolescents with Bipolar Disorder who are experiencing an episode of major depression while being treated with a mood stabilizer. The study involves a 2-week assessment period. Patients who are on stable, therapeutic doses of lithium or valproate and continue to have depression will be randomized to a 12-week treatment of fluoxetine or placebo. Those who respond favorably to treatment will be followed openly for an 18-week continuation phase.", - "NCTID": "NCT00005015" - }, - { - "brief_title": "Recognition and Early Intervention on Prodrome in Bipolar Disorders", - "phase": "", - "drugs": "['aerobic exercise', 'psychoeducation']", - "drugs_list": [ - "aerobic exercise", - "psychoeducation" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n have at least one biological parent diagnosed as bipolar disorder (bipolar I or II) \n\n have at least one of the following syndromes i) two or more DSM-IV defined hypomania/mania symptoms, lasting for at least 4 days; ii) two or more DSM defined major depressive symptoms, lasting for 1 week; iii) at least one of the psychotic symptoms, lasting at least 10 min for each manifestation, and 2-7 manifestations a week for at least 3 months, including: ideas of reference; odd ideas, odd belief, unusual perceptual experiences, bizarre thought or speech, Grandiosity, suspicious ideas, paranoid idea, odd mannerisms, hallucination, disorganized/catatonic behavior; iv)two or more of the DSM-IV defined Attention deficit hyperactivity disorder (ADHD)symptoms; and there must be clear evidence of clinically significant impairment in social, academic, or occupational functioning due to ADHD symptoms \n\n ", - "exclusion_criteria": ": \n\n DSM-IV defined Axis I disorders; \n\n Serious general medical illness; \n\n mental retardation; \n\n was/is treated with antipsychotic drugs; \n\n unable to complete neuropsychological tests due to physical conditions; \n\n in pregnancy and lactation; \n\n was taking thyroxine therapy in the last three months or is taking hormone therapy", - "brief_summary": "Background and study hypothesis:~Many studies including prospective studies have been demonstrated that a long symptomatic prodromal phase exists prior to the onset of full-brown bipolar disorder, lasting for 9-12 years (Egeland et al., 2000). During the prodromal stage, there are three main clusters of syndromes, including hypomania/mania symptoms, depressive symptoms, and signs of attention deficit hyperactivity disorders (Correll et al., 2007; Tillman et al., 2003; Mantere et al., 2008). Of the hypomania/mania symptoms, decreased sleep, elevated mood, irritability, mood lability, increased energy, and psychomotor agitation are present most frequently. The prodromal depressive symptoms are reported to be depressed mood, anhedonia, insomnia, feelings of worthlessness. Among patients with bipolar disorders, 22.5% reported to comorbid with pediatric ADHD. In addition, some symptoms are considered as non-specific such as decreased functioning, anger outburst, social isolation, and anxiety (Egeland et al., 2000).~Offspring of parents with bipolar disorders are much likely to present prodromal symptoms compared to offspring of healthy parents. In a 10-year longitudinal study using 55 prodromal symptoms checklist, , Egeland et al.(2002) found that 38% offspring of parents with bipolar disorder were considered as at risk compared to 17% in children of healthy parents. In a 15-year follow-up study, Duffy et al.,(2009) found that 32.7% offspring (aged 8-25 years old) of parents with bipolar disorder met the criteria of major mood episode.~Objectives:~One primary objective of this study is to prospectively identify the prodromal stage of bipolar disorder.~Another primary objective is to conduct a randomized, place-controlled trial of aerobic exercise on people who suffering from prodromal symptoms to the extent of significantly impaired function, with attempt at delaying or preventing the onset of a full-blown bipolar disorder.~Design of study and the procedures:~The study will consist of two phases: one-week screening period and a randomized, placebo-controlled, 3-month trial. During the screening period, offspring of parents with bipolar disorder will undergo systematically clinical evaluations. The offspring will be evaluated with clinical symptoms assessing scales, neuropsychological tests, magnetic resonance imaging. During the 3-month trial period, the offspring who meet the inclusion criteria will be randomly assigned to receive treatment of aerobic exercise, placebo, or wait-list group. Psychiatrists are scheduled to assess mood, treatment outcome during the 3-month trial.~Subjects and treatment It is expected that 120 offspring of parents with bipolar disorder aged between 10-25 years, meeting the inclusion of prodromal stage, will be included in the study. All of the offspring will undertake the Kiddie Sads Present and Lifetime Version (K-SADS-PL), and a 70 checklist items of potential prodromal symptoms suggest by us as well as by Dr. Correll et al. (2007). The parents of these offspring are to have a DSM-IV (Diagnostic and Statistical Manual of Mental Disorders)-defined bipolar disorder (bipolar I or II), confirmed by the Chinese version of Structured Clinical interview for DSM-IV-TR Axis I Disorders patient edition (SCID-I/P) [First et al., 2002]. The offspring are to be recruited through the referrals by their parents who will receive psychiatric services in the Guangzhou psychiatric Hospital.~The offspring will be randomly assigned to aerobic exercise and placebo controlled groups. The aerobic exercise would include cycling, jogging,table tennis, and playing badminton for 40 mins at least 3 times a week for 3 months. In each exercise, participants are supposed to exercise to the extent of getting sweaty. In the placebo group, participants will receive general psychoeducation, including delivering knowledge on symptoms, discussion of the suffering mental difficulties, and general coping techniques.~Significance:~Bipolar disorder is a common, chronic, and recurrent mental disorder. The recognition of prodromal stage of bipolar disorder and the early intervention on it may help delay or prevent the onset of bipolar disorder.", - "NCTID": "NCT01863628" - }, - { - "brief_title": "Staccato Loxapine in Agitated Patients With Bipolar Disorder", - "phase": "Phase 3", - "drugs": "['Inhaled Placebo', 'Inhaled loxapine 5 mg', 'Inhaled loxapine 10 mg']", - "drugs_list": [ - "Inhaled Placebo", - "Inhaled loxapine 5 mg", - "Inhaled loxapine 10 mg" - ], - "diseases": "['Bipolar I Disorder']", - "diseases_list": [ - "Bipolar I Disorder" - ], - "enrollment": "314.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female adult patients with bipolar 1 disorder and acute agitation \n\n ", - "exclusion_criteria": ": \n\n Agitation caused primarily by acute intoxication \n\n History of drug or alcohol dependence \n\n Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration", - "brief_summary": "Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.", - "NCTID": "NCT00721955" - }, - { - "brief_title": "Ziprasidone for the Treatment of Generalized Anxiety in Patients With Bipolar Disorder", - "phase": "Phase 4", - "drugs": "['Ziprasidone', 'Placebo']", - "drugs_list": [ - "Ziprasidone", - "Placebo" - ], - "diseases": "['Generalized Anxiety Disorder', 'Bipolar Disorder']", - "diseases_list": [ - "Generalized Anxiety Disorder", - "Bipolar Disorder" - ], - "enrollment": "3.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female outpatients, aged 18 to 75 years. \n\n Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II). \n\n Current diagnosis of Generalized Anxiety Disorder (GAD). \n\n Participants must be on at least one of the following mood stabilizers at steady dose for at least 4 weeks prior to randomization: lithium with blood levels between 0.4-1.4 meq/L, valproic acid/divalproate sodium (with levels between 50-150 ugm/dl) carbamazepine (blood levels between 4-12 mcg/ml), or lamotrigine (dosed 50-400 mg/day). \n\n ", - "exclusion_criteria": ": \n\n Pregnant or lactating women or others not using acceptable means of birth control (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, implanted progesterone rods stabilized for at least 3 months). \n\n Patients with current or history of schizophrenia, or patients with current mania, hypomania at study entry. Lifetime psychosis and dementia are exclusionary. \n\n Patients with current obsessive-compulsive disorder or posttraumatic stress disorder are excluded. \n\n Patients with a history of alcohol or substance abuse or dependence within the last three months. \n\n Patients with significant unstable medical illness likely to result in hospitalization or acute medical care. In addition, patients with an established diagnosis of diabetes mellitus are excluded. \n\n Current cognitive behavioral therapy directed toward the treatment of generalized anxiety disorder. \n\n History of hypersensitivity to or lack of response to ziprasidone. \n\n Concomitant treatment with other typical or atypical antipsychotics; patients should be off other typical or atypical antipsychotics for at least one week prior to study baseline. \n\n Patients with significant suicidal ideation or who have enacted suicidal behaviors within 3 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention. \n\n Patients who have had a psychiatric hospitalization (including for bipolar disorder) in the past 3 months are excluded. \n\n Seizure disorders with the exception of a history of febrile seizures if they occurred during childhood, were isolated, and did not recur in adulthood. \n\n History of Neuroleptic Malignant Syndrome. \n\n Individuals with current clinically significant orthostatic hypotension are excluded.", - "brief_summary": "This study proposes to examine the potential safety and efficacy of ziprasidone for patients with anxiety and bipolar disorder on anxiety outcomes, bipolar symptoms, and on measures of quality of life and resilience.", - "NCTID": "NCT00374543" - }, - { - "brief_title": "Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression", - "phase": "Phase 3", - "drugs": "['Quetiapine fumarate XR', 'Lithium carbonate']", - "drugs_list": [ - "Quetiapine fumarate XR", - "Lithium carbonate" - ], - "diseases": "['Acute Bipolar Depression']", - "diseases_list": [ - "Acute Bipolar Depression" - ], - "enrollment": "421.0", - "inclusion_criteria": "inclusion criteria: \n\n Outpatients that meet the diagnostic criteria for bipolar disorder I and bipolar disorder II with the most recent episode depressed \n\n The total score of the scale that's used for the evaluation of depression (HAM-D) should be \u226520 \n\n The total score of the scale that' used for the evaluation of mania (YMRS) should be \u226412 \n\n ", - "exclusion_criteria": ": \n\n Patients with a current DSM-IV-TR Axis I disorder other than bipolar disorder within 6 months of enrollment. Patients who pose a current serious suicidal or homicidal risk \n\n Use of drugs that induce or inhibit the hepatic metabolizing enzymes within 14 days before randomisation \n\n Patients who are unable to discontinue all psychoactive medications, including antidepressants, antipsychotics, and mood stabilizers at least 7 days prior to randomisation and consistent with the pharmacokinetics of the drug", - "brief_summary": "The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with quetiapine fumarate in combination with lithium in the treatment of a major depressive episode in patients with bipolar disorder.", - "NCTID": "NCT00883493" - }, - { - "brief_title": "Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder", - "phase": "", - "drugs": "['Cognitive behavioral therapy for insomnia']", - "drugs_list": [ - "Cognitive behavioral therapy for insomnia" - ], - "diseases": "['Bipolar Disorder', 'Insomnia']", - "diseases_list": [ - "Bipolar Disorder", - "Insomnia" - ], - "enrollment": "38.0", - "inclusion_criteria": "inclusion criteria: \n\n Fulfilling criteria for SCID-1-verified bipolar I or II disorder \n\n Euthymic, as defined by Montgomery \u00c5sberg Depression Rating Scale (MADRS) not higher than eleven, and Young Mania Rating scale (YMRS) not higher than five. \n\n Fulfilling DSM-IV criteria for primary insomnia or insomnia related to another mental disorder, as assessed by the Insomnia Interview Schedule (IIS). \n\n ", - "exclusion_criteria": ": \n\n Being or having been in a defined affective episode the last month before inclusion \n\n Hospitalization in the last two months before inclusion \n\n Working night shifts \n\n Sleep apnea \n\n Medical conditions incompatible with participation. \n\n Inability to cooperate in the 3-week initial phase before randomization.", - "brief_summary": "Patients with bipolar disorder suffer from sleep disturbances, even in euthymic phases. Changes in sleep are frequent signs of a new episode of (hypo)mania or depression. Cognitive behavioral therapy for insomnia is an effective treatment for primary insomnia, but has not been introduced to patients with bipolar disorder. The aim is to compare cognitive behavioral therapy added to 'treatment as usual' with just 'treatment as usual'. The investigators hypothesize that cognitive behavioral therapy will improve quality of sleep, stabilize minor mood variations and prevent new mood episodes in euthymic patients with bipolar disorder and insomnia.", - "NCTID": "NCT01704352" - }, - { - "brief_title": "Combination Therapy for the Treatment of Bipolar Disorders", - "phase": "Phase 3", - "drugs": "['Lithium', 'Lamotrigine', 'Divalproex', 'Placebo']", - "drugs_list": [ - "Lithium", - "Lamotrigine", - "Divalproex", - "Placebo" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "49.0", - "inclusion_criteria": "inclusion criteria: \n\n Bipolar I or II Disorder \n\n Meet criteria for rapid cycling, defined as four or more episodes over the past 12 months \n\n Meet criteria for a major depressive episode \n\n ", - "exclusion_criteria": ": \n\n History of intolerability of lithium, divalproex, or lamotrigine", - "brief_summary": "This study will compare triple and double drug regimens in the treatment of patients with depression, hypomania, or mania.", - "NCTID": "NCT00063362" - }, - { - "brief_title": "Parents With Bipolar Disorder: Relationship of Adaptation to Own Illness With Risk Perception and Coping With Perceived Risk to a Child", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "266.0", - "inclusion_criteria": "inclusion criteria: \n\n Have a diagnosis of bipolar disorder \n\n Be 18 years or older \n\n Be a biological parent of a child who is younger than 30 years old \n\n Be willing to participate in the survey \n\n The participant must be (or must have been) the primary caretaker for his or her child. \n\n ", - "exclusion_criteria": ": \n\n A participant must meet inclusion criteria. \n\n A participant s child cannot have been diagnosed with a mood disorder or other serious psychiatric disorder. \n\n A participant s child cannot have been adopted. \n\n The participant s child cannot be 30 years of age or older.", - "brief_summary": "Background:~Bipolar disorder is a common mood disorder that affects 1% to 2% of the population. Individuals with bipolar disorder tend to have periods of mania that are characterized by extra energy, very poor judgment or unrealistic beliefs about their thoughts and abilities, and an inability to complete thoughts and tasks; as well as major depressive episodes. The range and frequency of symptoms in affected individuals can vary greatly. Most individuals have cyclical symptoms and spend more time in a normal mood state than in an overtly symptomatic state.~Relatives of individuals with bipolar disorder have an increased risk for bipolar disorder and other mood disorders. Currently, risk assessment for recurrence of a mood disorder is based on family and medical histories; genetic testing has not proved particularly useful to date for assessing risks of a mood disorder.~Despite its prevalence, there is limited research on coping with bipolar illness. No published studies have examined adaptation to living with bipolar disorder or risk for bipolar disorder. More specifically, though a positive family history is the most important known risk factor for bipolar disorder, there are no published studies about response to the threat of future illness onset in children, risk modification efforts undertaken by affected parents, or coping with the risk for illness in children.~Objectives:~To examine parents appraisals of the impact and cause of bipolar disorder, and the association with their perceived risk for bipolar illness in their child and how they cope with their perception of risk to their child.~To assess whether parents adaptation to their own illness is associated with coping with perceived risk to their child.~To describe parents coping strategies related to perceived risk in their children.~Eligibility:~- Men and women at least 18 years of age who have been diagnosed with bipolar disorder and who have at least one biological child (30 years of age or younger). Participants must be a primary caregiver for their children.~Design:~Participants in this study will take an online survey and answer questions about disease perceptions, coping strategies, and adapting to a diagnosis of bipolar disorder, addressing issues such as the following:~Assessing the threat of bipolar disorder and coping with one s own illness.~Optimism/pessimism of the individual coping with the illness.~Perception of risk to a child, and coping with the perceived risk.~Data from this study will not be shared with the participants/respondents.", - "NCTID": "NCT01012180" - }, - { - "brief_title": "Olanzapine Versus Comparator in the Treatment of Bipolar Disorder", - "phase": "Phase 3", - "drugs": "['Olanzapine Hydrochloride', 'Lithium Carbonate']", - "drugs_list": [ - "Olanzapine Hydrochloride", - "Lithium Carbonate" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "140.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female in- or out-patients at least 18 years of age \n\n Patient must have a diagnosis of bipolar I disorder and currently display acute manic or mixed episodes (with or without psychotic features) according to the DSM-IV based on clinical assessment \n\n Patients must have a level of understanding sufficient to agree to all tests and examinations required by the protocol \n\n Patients must have a Y-MRS total score of greater than or equal to 20 at both visits 1 & 2 \n\n Patients must be considered reliable \n\n ", - "exclusion_criteria": ": \n\n Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry \n\n Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months \n\n Current or past diagnosis of schizophrenia or other psychotic disorder (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV \n\n Documented history of intolerance to olanzapine or Lithium Carbonate \n\n Treatment with clozapine within 4 weeks prior to visit 2. Treatment with other antipsychotic drugs or mood stabilizers within 2 days prior to visit 2", - "brief_summary": "The purpose of this trial is compare the efficacy of olanzapine and Lithium Carbonate in the treatment of bipolar disorder, manic or mixed episodes, in Chinese patients.", - "NCTID": "NCT00485680" - }, - { - "brief_title": "Clinical Trial of Mifepristone for Bipolar Depression", - "phase": "Phase 2", - "drugs": "['Mifepristone']", - "drugs_list": [ - "Mifepristone" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "110.0", - "inclusion_criteria": "HEALTHY VOLUNTEERS ARE CURRENTLY NOT BEING RECRUITED FOR THIS STUDY. \n\n inclusion criteria FOR BIPOLAR PATIENTS: \n\n Patients must meet the following inclusion criteria in order to participate in the study: \n\n Male or female inpatients in need of treatment for severe bipolar depression. \n\n 18-75 years of age. \n\n Women of childbearing potential must be using an adequate form of contraception as defined by one of the following: 1) a barrier method and 2) oral contraceptives plus a barrier method (women who are on an OCP will be kept on it others must agree to use only a barrier method). \n\n DSM-IV diagnosis of bipolar depression I/II, severe, with or without psychotic features. \n\n A current major depressive episode of at least 6 weeks' duration. \n\n Score of greater than or equal to 18 on the first 17-item HAM-D at the prestudy visit and at the first baseline phase visit. \n\n Score of 15 or greater on the HAM-D (17) at the end of the baseline period(s) (i.e., at randomization no more than 20% less than entry enrollment criteria). \n\n Score of greater than or equal to 4 on the CGI-BP scale at the prestudy and first visit and end of baseline phase. \n\n Judged to be in good physical health on the basis of medical history, physical examination, and laboratory screening. \n\n Able to understand procedures and agree to participate in the study by giving written informed consent. \n\n On lithium and/or valproate for at least 4 weeks (2 levels, 1 wk apart) \n\n However patients not on a mood stabilizer can have this started as an outpatient or inpatient for 4 weeks as discussed above. \n\n Able to come off of prior drugs and PRN zolpidem and lorazepam by start of baseline. \n\n ", - "exclusion_criteria": " FOR BIPOLAR PATIENTS: \n\n Patients will be excluded from the study if they meet any of the following criteria: \n\n Women who are pregnant, intending to become pregnant in the next month or breast-feeding. \n\n Treatment with any of the following therapies within the specified interval prior to baseline: Fluoxetine - 4 weeks; Investigational compounds 4 weeks; MAOIs 1 week; Other antidepressants 1 week. \n\n Contraindication or history of hypersensitivity to mifepristone as well as cortisol, and CRH. \n\n Clinically significant organ system disease where mifepristone would be contraindicated or interfere with medical treatment. \n\n Have evidence of any disorder that represents a contraindication to the use of mifepristone (such as adrenal disease or a condition requiring chronic corticosteroid administration). \n\n History of Addison's Disease, Cushing's Disease, insulin dependent diabetes, or other uncompensated endocrine conditions. \n\n Evidence of infection, severe liver, respiratory, or renal disease. \n\n Have clinically significant cardiovascular disease, e.g., angina, valve disease, arrhythmia, cardiac failure. \n\n Anemia (hemoglobin less than 10 g/dL or hematocrit less than 30%) \n\n Have a known clotting defect or are receiving anticoagulants. \n\n Rapid cycling in the last year (defined as greater than 6 episodes). \n\n History of porphyrias. \n\n Clinically significant abnormalities in physical exam, ECG, or laboratory assessments. \n\n History of any disease which, in the investigator's opinion may confound the results of the study or pose an additional risk, including but not limited to, history of organic mental disorder, seizures, or mental retardation. \n\n Substance dependence that is not in sustained full remission (DSM-IV definition) \n\n Other principal psychiatric diagnosis judged by the investigator to dominate the clinical presentation. In particular, patients with depressive symptoms more than 2 years in duration should be carefully evaluated to determine whether another psychiatric diagnosis exists which could interfere with efficacy and safety measurements. \n\n History of nonresponse to greater than four trials of antidepressants for the current episode (not including mood stabilizers) will exclude subjects. \n\n inclusion criteria FOR NORMAL CONTROLS: \n\n SCID-NP- no psychiatric diagnosis lifetime. \n\n Ages 18-75. \n\n Medically and psychiatrically healthy by history and no disallowed medications for 2 weeks, and agrees to no alcohol use for 1 week baseline period of study. \n\n No history of mood or anxiety disorder in first-degree relatives. \n\n Women of childbearing potential must be using adequate form of contraception as defined by one of the following: 1) a barrier method and 2) oral contraceptives plus a barrier method. \n\n ", - "brief_summary": "Bipolar Depression is a severe illness with high rates of psychiatric comorbidity and increased mortality related to suicide and medical illness. Hypothalamic pituitary axis (HPA) hyperactivity are found in bipolar disorder related to depression and mixed states. Patients with bipolar disorder also have cognitive difficulties and endocrine disturbances may contribute to such dysfunction. Antiglucorticoid therapies are novel treatments of mood disorder. Preliminary data in psychotic depression suggesting that mifepristone (RU-486), a glucocorticoid receptor antagonist, has antidepressant and salutary cognitive effects in a matter of days. In this study we examine the effects of mifepristone in severe bipolar depression in a parallel, double blind placebo controlled experiment. Bipolar subjects maintained on either lithium or valproate, after washout or prior antidepressants have a detailed neuroendocrine assessment. Patients approximately or almost 75 will receive eight days of mifepristone versus placebo after which patients are blindly crossed over to the opposite arm. Patients and a group of matched controls approximately or almost 35 will be compared with neuroendocrine, cognitive, and neurophysiologic testing to fully characterize their phenotype and explore biomarkers of response. It is hypothesized that stigmata of HPA axis hyperactivity and cognitive impairment will be predictive of response to antiglucocorticoid therapy with mifepristone.", - "NCTID": "NCT00043654" - }, - { - "brief_title": "Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder", - "phase": "Phase 3", - "drugs": "['Aripiprazole', 'Placebo', 'Lithium', 'Valproate']", - "drugs_list": [ - "Aripiprazole", - "Placebo", - "Lithium", - "Valproate" - ], - "diseases": "['Bipolar Disorder Mania']", - "diseases_list": [ - "Bipolar Disorder Mania" - ], - "enrollment": "493.0", - "inclusion_criteria": "Key inclusion criteria: \n\n Clinical diagnosis of bipolar I disorder mania, manic or mixed episode, with or without psychotic features \n\n Current ongoing lithium or valproate treatment with the possibility of benefiting, based on the investigator's clinical judgment, from adjunctive treatment with aripiprazole \n\n Therapeutic serum levels of lithium or valproate and a Young Mania Rating Total Score of 16 or higher at screening and baseline \n\n Participants taking current lithium or valproate treatment combined with antipsychotic medication other than aripiprazole are acceptable, provided that the other antipsychotic medication is washed out at least 3 days prior to the blood draw for therapeutic plasma levels of lithium and valproate determination. Long-acting antipsychotics must be washed out prior to entering the double-blind treatment. \n\n Key ", - "exclusion_criteria": ": \n\n Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of investigational product \n\n A diagnosis of delirium, dementia, amnesia or other cognitive disorder, or a psychotic disorder \n\n Current diagnosis of delirium, dementia, a cognitive disorder (ie, amnesia), or a psychotic disorder (ie, schizophrenia or schizoaffective disorder) \n\n Current diagnosis of bipolar II disorder, bipolar disorder not otherwise specified, or any other primary psychiatric disorder other than bipolar I disorder mania \n\n Thyroid pathology \n\n Demonstrated cocaine abuse or dependence within the past 3 months prior to screening. \n\n History of neuroleptic malignant syndrome from antipsychotic agents \n\n Manic symptoms that investigator considers refractory to treatment \n\n Previous nonresponsive (by investigator judgment) to aripiprazole for manic symptoms \n\n Significant risk of suicide based on history, mental status exam, or investigator judgment.", - "brief_summary": "The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.", - "NCTID": "NCT00665366" - }, - { - "brief_title": "Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder", - "phase": "Phase 4", - "drugs": "['Ramelteon', 'Placebo']", - "drugs_list": [ - "Ramelteon", - "Placebo" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria: \n\n Provision of written informed consent before initiation of any study-related procedures \n\n Men and women aged 18 to 65 years. \n\n A documented clinical diagnosis according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision) meeting criteria 296.4x Bipolar I disorder, most recent episode manic, 296.6x Bipolar I disorder, most recent episode mixed, or 296.5x Bipolar I disorder, most recent episode depressed. \n\n PSQI total score of >=5. \n\n MADRS total score of <=12. \n\n YMRS total score of <= 12 \n\n Female patients of childbearing potential must have a negative urine pregnancy test at enrollment and be willing to use a reliable method of birth control, i.e., double-barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device or tubal ligation, during the study. \n\n Be able to understand and comply with the requirements of the study, as judged by the investigator. \n\n Outpatient status at enrollment. \n\n ", - "exclusion_criteria": ": \n\n Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status. \n\n Presence of prohibited medications of antidepressants (including MAOI's) and systemic corticosteroids. \n\n Patients with a diagnosis of primary insomnia disorders \n\n Patients with a diagnosis of severe chronic obstructive pulmonary disease \n\n A clinical finding that is untreated (eg, hypertension, poorly controlled diabetes, angina) or that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect the study medication. \n\n Patients with active substance abuse diagnoses (except tobacco abuse). \n\n Known history of intolerance or hypersensitivity to ramelteon or to any other component in the tablet.", - "brief_summary": "The purpose of this study is to determine whether treating sleep difficulties in patients with bipolar disorder also improves their mood stability.", - "NCTID": "NCT00552760" - }, - { - "brief_title": "Functional and Neurochemical Brain Changes Bipolar Depression", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Depression, Bipolar']", - "diseases_list": [ - "Depression", - "Bipolar" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria - Depressed bipolar patients (N=100; 15-20 patients/year): \n\n Patients will meet DSM-IV criteria for type I bipolar disorder, depressed, as determined by structured interview and best-estimate diagnostic procedures.138 \n\n Patient has experienced a maximum of three documented affective episodes. \n\n Patient has been off medications for one week prior to study enrollment. \n\n Patient has a Hamilton Depression Rating Scale (HDRS) total score \u226520 \n\n Patient is between the ages of 12 and 35 years. \n\n ", - "exclusion_criteria": ": All subjects will be excluded from participation for the following reasons: \n\n Any chemical use disorder within 3 months. \n\n Any history of significant suicidality that would place the patient at risk to participate in this protocol. \n\n Current score \u22653 on item 3 of the HDRS-17 (Suicide Item) \n\n Any medical or neurological disorder that could influence fMRI results. \n\n A history of mental retardation or an estimated IQ total score <85. \n\n An MRI scan is contraindicated in the subject for any reason. \n\n The patient lives >100 miles from the University of Cincinnati or cannot attend follow-up visits. \n\n Meets DSM-IV criteria for a bipolar mixed episode", - "brief_summary": "The purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving quetiapine or lithium, in order to better understand who benefits from treatment and why they respond to medications.", - "NCTID": "NCT00608296" - }, - { - "brief_title": "Reducing Suicidal Ideation Through Insomnia Treatment", - "phase": "Phase 4", - "drugs": "['Zolpidem-CR', 'Placebo']", - "drugs_list": [ - "Zolpidem-CR", - "Placebo" - ], - "diseases": "['Insomnia', 'Depression', 'Suicidal Ideation']", - "diseases_list": [ - "Insomnia", - "Depression", - "Suicidal Ideation" - ], - "enrollment": "103.0", - "inclusion_criteria": "inclusion criteria: \n\n Persons 18-65 years of age \n\n Persons with confirmed DSM-IV diagnosis of MDE by SCID \n\n Persons with Research Diagnostic Criteria diagnosis of insomnia \n\n Persons free of all psychotropic medications for one week before baseline assessment, except that prior FLX treatment will require 4 weeks of abstinence, and MAOIs will require 2 weeks of abstinence. \n\n Persons with Scale for Suicide Ideation (SSI) scores >2 \n\n Persons with Hamilton Rating Scale for Depression (HRSD24) score >20 \n\n Persons with Mini Mental State Exam (MMSE) score >24 \n\n Persons with Insomnia Severity Index (ISI) score > 7 \n\n Persons with habitual sleep latency > or = 30 minutes or wake time in the middle of the night of > or = 30 minutes, and sleep efficiency < 85% \n\n ", - "exclusion_criteria": ": \n\n Non-English speaking, reading, writing persons \n\n Persons who pose imminent danger to self or others \n\n Persons with severe suicidal ideation (C-SSRS Suicidal Ideation Score >3) \n\n Persons with clinical diagnosis of dementia \n\n Persons with active or past diagnosis of alcohol or substance abuse, bipolar disorder, schizophrenia per the SCID \n\n Persons who screen positive for moderate-severe sleep apnea (AHI >10) or a prior sleep laboratory-confirmed diagnosis of a primary sleep disorder, such as sleep apnea or periodic limb movement disorder. \n\n Persons with BMI > 50 \n\n Persons with a self-reported history of napping > 2 times per week (as these are associated with sleep apnea and periodic limb movement disorder in depressed insomniacs) \n\n Persons who might be harmed by exposure to hypnotics, including pregnant women and patients with respiratory conditions", - "brief_summary": "Epidemiologic reports have linked insomnia to suicidal ideation and suicide death. However, no studies have determined whether treating insomnia decreases the risk of suicidality. We have new data indicating that (1) the link between insomnia and suicidal ideation holds true in clinical trials of depressed insomniacs, (2) dysfunctional cognitions about sleep are related to suicidal ideas, and (3) treatment of insomnia with hypnotics leads to a reduction of suicidal ideation. We now propose to test whether cautious use of hypnotics in suicidal, depressed insomniacs may reduce suicide risk in a multi-site clinical trial.", - "NCTID": "NCT01689909" - }, - { - "brief_title": "Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder (Zip Ad)", - "phase": "Phase 4", - "drugs": "['ziprasidone']", - "drugs_list": [ - "ziprasidone" - ], - "diseases": "['Medication Adherence', 'Bipolar Disorder']", - "diseases_list": [ - "Medication Adherence", - "Bipolar Disorder" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of Type I or II BD for at least 6 months (confirmed with MINI) \n\n On maintenance evidence-based treatment for BD (lithium, antipsychotic, anticonvulsant) \n\n Have weight gain concerns that individual believes are related to BD medication treatment \n\n Sub-optimal adherence as measured by the Tablet Routines Questionnaire (TRQ) and which the patient feels is related to weight gain concerns. TRQ threshold will be defined as missing an average of 20% or more of all prescribed BD treatment in the last week or month or missing 20% or more of the offending agent in the last week or last month. This is consistent with methodologies in PIs previous BD adherence studies \n\n ", - "exclusion_criteria": ": \n\n Known resistance or intolerance to ziprasidone \n\n Medical contraindication to ziprasidone \n\n Individuals on ziprasidone immediately prior to study enrollment \n\n Prior or current treatment with clozapine \n\n Diagnosis of eating disorder \n\n Individuals whose sub-optimal adherence is related to inability to pay for BD medication treatment or inability to arrange transportation to BD treatment clinical visits \n\n Concurrent medical condition or psychiatric illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial \n\n Current substance dependence \n\n High risk of harm to self or others \n\n Female who is currently pregnant or breastfeeding", - "brief_summary": "Psychotropic-related weight gain is a common concern among patients with bipolar disorder (BD). This concern affects an individual's satisfaction with treatment and may lead to reduced adherence and illness relapse. Patient-focused care is attentive to patient concerns while at the same time utilizing evidence-based treatments. Ziprasidone is currently FDA approved for the maintenance treatment of BD. Ziprasidone may be associated with less weight gain compared to some alternative BD maintenance treatments. The proposed project will evaluate how switching to ziprasidone may affect patient adherence, drug attitudes, satisfaction with care and clinical outcomes (psychiatric symptoms, functional status, weight) among BD patients concerned with weight gain.", - "NCTID": "NCT01293825" - }, - { - "brief_title": "Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia", - "phase": "Phase 3", - "drugs": "['zolpidem-MR (modified release)', 'zolpidem (SL800750)', 'placebo']", - "drugs_list": [ - "zolpidem-MR (modified release)", - "zolpidem (SL800750)", - "placebo" - ], - "diseases": "['Sleep Initiation and Maintenance Disorders']", - "diseases_list": [ - "Sleep Initiation and Maintenance Disorders" - ], - "enrollment": "113.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria", - "exclusion_criteria": "", - "brief_summary": "The primary objective is to evaluate the hypnotic efficacy of zolpidem-MR (modified release) 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo in patients with primary insomnia and sleep maintenance difficulties, using polysomnography (PSG) recordings and patient sleep questionnaires.~The secondary objective is to evaluate the clinical safety and tolerability of zolpidem-MR 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo.", - "NCTID": "NCT00630175" - }, - { - "brief_title": "Assess the Effect of Zolpidem, Silenor & Placebo on Arousability, Ataxia/Balance & Cognition in Healthy Volunteers", - "phase": "Phase 4", - "drugs": "['Silenor 6 mg', 'zolpidem 10 mg', 'Placebo', 'Placebo']", - "drugs_list": [ - "Silenor 6 mg", - "zolpidem 10 mg", - "Placebo", - "Placebo" - ], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "52.0", - "inclusion_criteria": "inclusion criteria: \n\n Be in good general health as determined by the investigator; \n\n Have a 3-month history of a normal nightly sleep pattern based on the subject's self report ; \n\n A usual time in bed \n\n A regular bedtime between 2200 and 2400 hours \n\n No habitual daytime napping; \n\n Epworth Sleepiness Scale score \u2264 10; \n\n Be able to read, understand, and provide written/dated informed consent before enrolling in the study, and must be willing and able to comply with all study procedures; \n\n Be able to follow verbal and written instructions provided in English \n\n ", - "exclusion_criteria": ": \n\n Have a body mass index (BMI) >35 kg/m2 \n\n Have symptoms consistent with the diagnosis of any sleep disorder (e.g., insomnia, sleep apnea, narcolepsy, periodic leg movements, or restless leg syndrome); \n\n On screening PSG AHI > 10 or PLMAI >10; \n\n Have a known or suspected diagnosis of Acquired Immune Deficiency Syndrome (AIDS), or have tested seropositive for human immunodeficiency virus (HIV) antibody or antigen previously; \n\n Have any clinically significant abnormal finding in physical examination, neurological assessment, vital signs, elevated body temperature, or clinical laboratory tests, as determined by the Investigator; \n\n Have a known exaggerated pharmacological sensitivity, hypersensitivity, or history of a clinically significant adverse reaction to zolpidem; \n\n Have a known or exaggerated pharmacological sensitivity, hypersensitivity, or intolerance to doxepin HCl, any tricyclic antidepressant, or antihistamine; \n\n Currently taking cimetidine or a monoamine oxidase inhibitor (MAOI); \n\n Current diagnosis of severe urinary retention; \n\n Current diagnosis of untreated glaucoma; \n\n Intends to use any medication including over-the-counter (OTC) medications that would interfere with normal sleep architecture (such as systemic steroids, beta-adrenergic blockers, amphetamines, modafinil, etc.); \n\n Self-reports use of products containing nicotine of greater than 15 cigarettes daily, or cannot avoid products containing nicotine during the normal sleep periods; \n\n Self report consumption of more than five alcoholic beverages on any one day or greater than 14 alcoholic beverages weekly over the past week; \n\n Have a history of epilepsy or serious head injury; \n\n Used CYP450 2D6 inducers or inhibitors within 7 days before screening; \n\n Have used prescribed or OTC medications within 30 days of screening (Day 0) or intend to use any prescription or OTC medication during the study that may interfere with the evaluation of the study drug. \n\n Have used an investigational drug within 30 days or five half lives (whichever is longer) before screening, or plans to use an investigational drug during the study or have used doxepin or zolpidem previously. \n\n Score of < 40 on the BBS at screening", - "brief_summary": "This is a Phase IV, randomized, double-blind, placebo-controlled, four-arm crossover study. The study will assess the effects of a single dose of Silenor 6 mg compared with matching placebo and a single dose of zolpidem 10 mg compared to its matching placebo at the respective T-max in normal healthy adult male volunteers. The study will be conducted in approximately 52 male subjects", - "NCTID": "NCT02353299" - }, - { - "brief_title": "A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients", - "phase": "Phase 4", - "drugs": "['Zolpidem MR', 'Zolpidem IR']", - "drugs_list": [ - "Zolpidem MR", - "Zolpidem IR" - ], - "diseases": "['Sleep Initiation and Maintenance Disorders', 'Primary Insomnia']", - "diseases_list": [ - "Sleep Initiation and Maintenance Disorders", - "Primary Insomnia" - ], - "enrollment": "132.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of primary insomnia based on DSM-IV criteria (307.42) \n\n Written informed consent has been obtained \n\n ", - "exclusion_criteria": ": \n\n Patients with sleep apnea syndrome, narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome \n\n Patients with hepatic failure, myasthenia gravis, or hypersensitivity to zolpidem \n\n Patients who are known to be current drug or alcohol abuser or likely to concomitantly consume alcoholic beverages (more than 3 times/week) \n\n Patients who have received antihistamines or antipsychotics will not allow to discontinue the previous medication throughout the study \n\n Patients who are pregnant, lactating or intend to become pregnant during the study period \n\n Patients who have received antidepressants or anxiolytics will not allow to change the dose or discontinue the previous medication throughout the study \n\n Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial \n\n Participation in any clinical trial within 1 month prior to randomization", - "brief_summary": "The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified release) compared to zolpidem IR (immediate release) in patients with primary insomnia.", - "NCTID": "NCT01181232" - }, - { - "brief_title": "Bioequivalency Study of 300 mg Lithium Carbonate Under Fasting Conditions", - "phase": "", - "drugs": "['Lithium']", - "drugs_list": [ - "Lithium" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "29.0", - "inclusion_criteria": "inclusion criteria: \n\n No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. \n\n ", - "exclusion_criteria": ": \n\n Positive test for HIV, Hepatitis B, or Hepatitis C. \n\n Treatment with known enzyme altering drugs. \n\n History of allergic or adverse response to lithium, or any comparable or similar product.", - "brief_summary": "The objective of this study was the bioequivalence of a Roxane lithium carbonate 300 mg extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release tablet under fasting conditions using a single-dose, randomized, 2 treatment, 2-period, 2-sequence crossover design.", - "NCTID": "NCT00601536" - }, - { - "brief_title": "A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients", - "phase": "Phase 4", - "drugs": "['Zolpidem MR', 'Estazolam']", - "drugs_list": [ - "Zolpidem MR", - "Estazolam" - ], - "diseases": "['Sleep Initiation and Maintenance Disorders', 'Primary Insomnia']", - "diseases_list": [ - "Sleep Initiation and Maintenance Disorders", - "Primary Insomnia" - ], - "enrollment": "42.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of primary insomnia based on DSM-IV criteria (307.42) \n\n Written informed consent has been obtained \n\n ", - "exclusion_criteria": ": \n\n Patients with sleep apnea syndrome, narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome \n\n Patients with hepatic failure, myasthenia gravis, or hypersensitivity to zolpidem \n\n Patients who are known to be current drug or alcohol abuser or likely to concomitantly consume alcoholic beverages (more than 3 times/week) \n\n Patients who are pregnant, lactating or intend to become pregnant during the study period \n\n Patients who have received antidepressants or anxiolytics will not allow to change the dose or discontinue the previous medication throughout the study \n\n Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial \n\n Participation in any clinical trial within 1 month prior to randomization", - "brief_summary": "The purpose of the study is to investigate the efficacy and safety of zolpidem modified release (MR) tablet using estazolam (Eurodin) as a comparative drug in patients with primary insomnia.", - "NCTID": "NCT00956319" - }, - { - "brief_title": "A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia", - "phase": "Phase 3", - "drugs": "['zolpidem tartrate sublingual tablet 3.5mg', 'zolpidem tartrate sublingual tablet 1.75mg', 'Placebo']", - "drugs_list": [ - "zolpidem tartrate sublingual tablet 3.5mg", - "zolpidem tartrate sublingual tablet 1.75mg", - "Placebo" - ], - "diseases": "['Insomnia']", - "diseases_list": [ - "Insomnia" - ], - "enrollment": "82.0", - "inclusion_criteria": "inclusion criteria: \n\n Insomnia as defined by DSM-IV criteria and supported by subject diary \n\n Male or female between the ages of 18-64 years \n\n Body mass index (BMI) between 18-34 kg/m^2 \n\n Females of childbearing potential must use a medically acceptable method of contraception \n\n Capable of understanding and willing to comply with study procedures and has provided informed consent \n\n ", - "exclusion_criteria": ": \n\n Females who are pregnant, breast-feeding or have a positive pregnancy test \n\n Any circadian rhythm disorder including planned travel across several time zones during the study period \n\n Known hypersensitivity to Zolpidem \n\n Has performed regular shift work with the past several months prior to screening \n\n An acute clinically significant illness or surgery as determined by the PI within 30 days of screening \n\n Patients that have used any central nervous system (CNS) medication or other medication known to impact the sleep/wake cycle \n\n A history of psychiatric disorder as defined by DSM-IV \n\n A history of drug addiction or alcohol abuse \n\n Any current significant disease, unless adequately controlled with a protocol allowed medication \n\n Known history of HIV or Hepatitis B or C \n\n Patients who have received an investigational drug within several months of screening", - "brief_summary": "The purpose of this study is to evaluate sleep onset following administration of Transcept zolpidem tartrate sublingual tablet versus placebo in adult insomnia patients.", - "NCTID": "NCT00380081" - } - ], - "2": [ - { - "brief_title": "Ginger.io Behavioral Health Study", - "phase": "", - "drugs": "['Ginger.io Smartphone Application']", - "drugs_list": [ - "Ginger.io Smartphone Application" - ], - "diseases": "['Anxiety', 'Depression', 'Bipolar I Disorder', 'Bipolar II Disorder']", - "diseases_list": [ - "Anxiety", - "Depression", - "Bipolar I Disorder", - "Bipolar II Disorder" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 or older \n\n Experiencing mood disorders (e.g. depression, anxiety, bipolar) defined as a visit with a specified DSM-V code (295.7 Schizoaffective Disorder (Depressive type), 295.7 Schizoaffective Disorder (Bipolar type), 296.41 Bipolar I Current or most recent episode manic Mild, 296.42 Bipolar I Current or most recent episode manic mod, 296.43 Bipolar I Current or most recent episode manic sev, 296.44 Bipolar I Current or most recent episode manic w psychotic, 296.45 Bipolar I Current or most recent episode manic in partial remission, 296.46 Bipolar I Current or most recent episode manic in full remission, 296.40 Bipolar I Current or most recent episode unspecified, 296.40 Bipolar I Current or most recent episode hypomanic, 296.45 Bipolar I Current or most recent episode hypomanic in partial remission, 296.46 Bipolar I Current or most recent episode hypomanic in full remission, 296.40 Bipolar I Current or most recent episode hypomanic unspecified, 296.51Bipolar 1 Current or most recent episode depressed mild, 296.52 Bipolar 1 Current or most recent episode depressed mod, 296.53 Bipolar 1 Current or most recent episode depressed sev, 296.54 Bipolar 1 Current or most recent episode depressed w psychotic, 296.55 Bipolar 1 Current or most recent episode depressed in partial remission, 296.56 Bipolar 1 Current or most recent episode depressed in full remission, 296.50 Bipolar 1 Current or most recent episode depressed unspecified, 296.7 Bipolar 1 current or most recent episode unspecified, 296.89 Bipolar II, 301.13 Cyclothymic, 296.83 Bipolar due to Medical Condition, 296.89 Other Specified Bipolar, 296.80 Unspecified Bipolar, 296.99 Disruptive Mood Dysregulation disorder, 296.21 Major Depressive Disorder Single Episode Mild, 296.22 Major Depressive Disorder Single Episode mod, 296.23 Major Depressive Disorder Single Episode sev, 296.24 Major Depressive Disorder Single Episode w psychotic, 296.25 Major Depressive Disorder Single Episode in partial remission, 296.26 Major Depressive Disorder Single Episode in full remission, 296.20 Major Depressive Disorder Single Episode unspecified, 296.31 Major Depressive Disorder Recurrent Episode mild, 296.32 Major Depressive Disorder Recurrent Episode moderate, 296.33 Major Depressive Disorder Recurrent Episode severe, 296.34 Major Depressive Disorder Recurrent Episode w psychotic, 296.35 Major Depressive Disorder Recurrent Episode in partial remission, 296.36 Major Depressive Disorder Recurrent Episode in full remission, 296.30 unspecified, 300.4 Persistent Depressive Disorder (Dysthymia), 625.4 Premenstrual Dysphoric Disorder, 293.83 Depressive Disorder due to another medical condition, 311 Other specified depressive disorder, 311 Unspecified Depressive disorder, 309.21 Separation anxiety disorder, 300.29 Specific Phobia, 300.23 Social anxiety do, 300.01 Panic Disorder, 300.22 Agoraphobia, 300.02 GAD, 293.84 Anxiety do due to another med condition, 300.09 other specified anxiety do, 300.00 Uspecified Anxiety do, 309.0 Adjustment do with depressed mood, 309.24 Adjustment do with anxiety, 309.28 Adjustment do with mixed, 309.4 Adjustment do with w disturbance of emotions and conduct, 309.9 Adjustment do unspecified, 300.7 Illness anxiety disorder, 293.83 Mood do NOS, 296.9 Mood do unspecified, 291.89 alcohol inducted mood do, 292.84 amphetamine inducted mood do 292.84 cocaine inducted mood do, unspecified inducted mood do, 296.66 episodic mood dis unspecified, 296.64 Severe mixed bipolar do) \n\n Possessing a smartphone with either an Android or iOS platform \n\n Able to read and write in English \n\n Have a designated primary behavioral health care provider who is either using the app with their patients (intervention) or is issuing the surveys on paper in their clinic (control) \n\n ", - "exclusion_criteria": ": \n\n None", - "brief_summary": "This Study will evaluate the impact of a smartphone-based platform on a range of outcomes for medically-underserved patients with mood disorders (e.g. depression, anxiety, bipolar) cared for in a large statewide community health center. The primary goal of the Study is to reduce emergency room (ER) visits, hospitalizations, and to look at changes in service utilization by using the Ginger.io platform to enhance communication between behavioral health providers and their patients, increasing the early detection of exacerbations in mood disorders (e.g. depression, anxiety, bipolar) and proactive outreach. The secondary goal is to improve clinical & behavioral health outcomes.", - "NCTID": "NCT02491307" - }, - { - "brief_title": "Suicidal Behavior in Patients Diagnosed With Bipolar Disorder", - "phase": "", - "drugs": "['Interpersonal and Social Rhythm Therapy (ISRT)', 'Bipolar-Specific Cognitive Behavioral Therapy (CBT)', 'Mindfulness-Based Stress Reduction (MBSR)', 'Psycho-education & Understanding Bipolar Medications Therapy']", - "drugs_list": [ - "Interpersonal and Social Rhythm Therapy (ISRT)", - "Bipolar-Specific Cognitive Behavioral Therapy (CBT)", - "Mindfulness-Based Stress Reduction (MBSR)", - "Psycho-education & Understanding Bipolar Medications Therapy" - ], - "diseases": "['Depression', 'Alcoholism', 'Drug Abuse']", - "diseases_list": [ - "Depression", - "Alcoholism", - "Drug Abuse" - ], - "enrollment": "130.0", - "inclusion_criteria": "inclusion criteria: \n\n English speaking \n\n Diagnosis of Bipolar Disorder (BD) \n\n Able to provide written informed consent \n\n ", - "exclusion_criteria": ": \n\n Cognitive impairments \n\n Acutely psychotic \n\n Medically unstable \n\n History of schizophrenia spectrum disorder \n\n History of mood incongruent psychotic symptoms \n\n History of primary substance disorder \n\n History of primary organic disease and/or dementia", - "brief_summary": "The purpose of this study is to learn the environmental and psychological factors that impact suicidality in patients diagnosed with Bipolar Disorder. Additionally, the study aims to identify treatments to reduce the suicidal behavior and improve quality of life through a 6-week group-based intervention program.", - "NCTID": "NCT02604277" - }, - { - "brief_title": "BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder", - "phase": "", - "drugs": "['non-interventional']", - "drugs_list": [ - "non-interventional" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "553.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with diagnosis of Bipolar Disorder (DSM-IV TR) \n\n Patients or their legal representatives have provided informed consent \n\n ", - "exclusion_criteria": ": \n\n Patients are unable to complete or to understand health questionnaires in Spanish language \n\n Patients enrolled in clinical trials or other studies", - "brief_summary": "To assess the prevalence of Metabolic Syndrome in Spanish population with Bipolar I or II Disorder.~To analyse the clinical progress disease in patients with Bipolar I or II Disorder for 12 months using the assessment of the symptoms disease and the progress of metabolic and cardiovascular risk.~To analyse the health status, quality of life and functioning/disability of patients.", - "NCTID": "NCT00584961" - }, - { - "brief_title": "Maintenance Therapies in Bipolar Disorders", - "phase": "Phase 3", - "drugs": "['Individual psychotherapy', 'Lithium carbonate']", - "drugs_list": [ - "Individual psychotherapy", - "Lithium carbonate" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n - \n\n Patients must have: \n\n Acute bipolar I illness and be experiencing a manic or depressed episode at the time of study entry. \n\n - \n\n Required: \n\n Current treatment with lithium carbonate.", - "exclusion_criteria": "", - "brief_summary": "The purpose of this study is to see if adding a regimen of individualized psychotherapy can help bipolar I patients who are on lithium.~While having a manic or depressed episode patients will be assigned randomly (like tossing a coin) to receive appropriate medication either with or without additional individual psychotherapy. If a patient responds well, he/she will again be assigned randomly to receive further preventative treatment in which medication will be managed either with continued medication clinic visits alone or with additional individual psychotherapy (the patient may not receive the same additional treatment this time). Patient response to treatment will be evaluated throughout the study. If manic/depressive symptoms return at any point during the study, the patient will be treated with appropriate medication and will continue the study.~An individual may be eligible for this study if he/she:~Has Bipolar I disorder, is experiencing a manic or depressed episode at the time of study entry, and is at least 18 years old.", - "NCTID": "NCT00000369" - }, - { - "brief_title": "Sleep Disturbance and Bipolar Disorder", - "phase": "Phase 3", - "drugs": "['Cognitive behavioral therapy for insomnia', 'Bipolar education']", - "drugs_list": [ - "Cognitive behavioral therapy for insomnia", - "Bipolar education" - ], - "diseases": "['Bipolar Disorder', 'Dyssomnias']", - "diseases_list": [ - "Bipolar Disorder", - "Dyssomnias" - ], - "enrollment": "52.0", - "inclusion_criteria": "inclusion criteria: \n\n Bipolar disorder patients with sleep disturbance \n\n Meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Text Revision (DSM-IV-TR; APA, 2000) diagnostic criteria for bipolar disorder type 1 (established with the SCID: Structured Clinical Interview for DSM-IV). \n\n Being inter-episode throughout the experiment as defined by cutoffs widely used in previous research. On the basis that a drug-free group would likely be unfeasible and unrepresentative, participants will not be excluded on the basis of medications prescribed for bipolar disorder. Comorbidity will be allowed as long as bipolar disorder is the primary diagnosis. However, it is necessary to assess comorbidity for reporting purposes. \n\n Participants who have a history of bipolar 1 or suicidal ideation must be under the care of a psychiatrist. \n\n Experience distress related to significant sleep disturbance. \n\n ", - "exclusion_criteria": ": \n\n Presence of an active and progressive physical illness (e.g., congestive heart failure, cancer, COPD) or neurological degenerative diseases (e.g., dementia, multiple sclerosis) directly related to the onset and course of insomnia; \n\n Alcohol or drug abuse (except nicotine) within the past year \n\n Active posttraumatic stress disorder \n\n Evidence of sleep apnea, restless legs syndrome or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g., delayed or advanced sleep phase syndrome) \n\n Patients who pose a current suicidal risk or homicidal risk (assessed by treating psychiatrist) or who have made a suicide attempt within the past 6 months. \n\n Pharmacotherapy for sleep defined as the benzodiazepine and non-benzodiazepine hypnotics that operate via the GABA A receptor complex and are FDA approved for the treatment of insomnia, selective melatonin agonists, benzodiazepine anxiolytics and over the counter medications with proven efficacy such as melatonin or herbs such as St. Johns wort. \n\n Use of certain medications known to alter sleep (e.g., steroids, theophylline, propranolol, antihistamines that cause drowsiness).", - "brief_summary": "The study aims to evaluate a psychological intervention for individuals who suffer from sleep disturbance and bipolar disorder. We are hoping that this treatment will: (1) improve the quality of life of individuals with bipolar disorder who are suffering from sleep disturbance and (2) reduce the risk of, or help prevent, episodes.", - "NCTID": "NCT00993850" - }, - { - "brief_title": "Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)", - "phase": "", - "drugs": "['lithium', 'valproate', 'bupropion', 'paroxetine', 'lamotrigine', 'risperidone', 'inositol', 'tranylcypromine', 'Cognitive Behavioral Therapy', 'Family-focused Therapy', 'Interpersonal and Social Rhythms Therapy']", - "drugs_list": [ - "lithium", - "valproate", - "bupropion", - "paroxetine", - "lamotrigine", - "risperidone", - "inositol", - "tranylcypromine", - "Cognitive Behavioral Therapy", - "Family-focused Therapy", - "Interpersonal and Social Rhythms Therapy" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "5000.0", - "inclusion_criteria": "General inclusion criteria: \n\n current age 15 or older (Best Practice Pathway) or 18 years or older (Randomized Care Pathways); \n\n able to give informed consent for data to be harvested; \n\n meet DSM-IV criteria for Bipolar I Disorder, Bipolar II Disorder, Bipolar Disorder NOS, or Cyclothymic Disorder; \n\n undergo a complete standard evaluation including clinical interview, self ratings, and laboratory studies; \n\n meet with Clinical Specialist as scheduled; \n\n able to complete all Study Registry Forms within 3 months of registration. \n\n General ", - "exclusion_criteria": ": \n\n unwilling or unable to adhere to basic study requirements (i.e., complete rating forms, or attend scheduled evaluations); \n\n not competent to give informed consent in the opinion of the investigator (e.g., psychotic). \n\n Participants will be asked to remain in the study for up to five years so that the investigators can document and evaluate long-term treatment outcome. Participants will meet with their STEP-BD psychiatrist for periodic evaluations and/or treatment adjustments during the course of the study, fill out various self-rating forms, and when applicable, participate in psychotherapy. One of the psychotherapy options, Family-Focused Therapy, will require participants and their families to attend counseling sessions together. Overall, the estimated amount of time required from participants in the study is 2 to 4 hours per month.", - "brief_summary": "A long-term study of current treatments for bipolar disorder, including medications and psychosocial therapies.", - "NCTID": "NCT00012558" - }, - { - "brief_title": "A Study of the Association Between Tobacco Smoking and Bipolar Affective Disorder", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18-65 male or female \n\n DSM -IV criteria for bipolar I affective disorder \n\n Ability and willingness to sign informed consent for participation in the study \n\n ", - "exclusion_criteria": ": \n\n Unwillingness or inability to participate in the study", - "brief_summary": "The purpose of this study is to examine whether tobacco smoking is associated with bipolar affective disorder (severity of depressive and manic symptoms, presence of psychotic symptoms, history of a suicide attempts and other clinical features.)", - "NCTID": "NCT00741299" - }, - { - "brief_title": "Escitalopram in Bipolar Depression: a Placebo-controlled Study of Acute and Maintenance Treatment", - "phase": "Phase 4", - "drugs": "['escitalopram']", - "drugs_list": [ - "escitalopram" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with bipolar disorder in major depressive episode according to DSM-IV \n\n MADRS score of at least 20 points at screening and baseline \n\n 18-70 years of age \n\n Unchanged dose of mood stabilising medication for at least six weeks prior to inclusion \n\n Voluntary, informed and written consent \n\n ", - "exclusion_criteria": ": \n\n Non-affective psychotic symptoms at screening \n\n Pregnancy or breast-feeding \n\n Fertile women without appropriate contraception (the pill, IUD, or contraceptive injection) \n\n Substance dependence during the last three months prior to baseline \n\n Mental retardation and organic brain disorders \n\n Suicide risk that mandates specific measures \n\n Novel (within three months) or unstable medical conditions \n\n Clinically significant abnormal results on medical examination or blood samples \n\n Exposure to escitalopram during the last three months \n\n Allergic reactions to citalopram or escitalopram \n\n Anorexia nervosa with body mass index below 18 \n\n Formal psychotherapy started within six weeks of screening \n\n Electroconvulsive therapy (ECT) during the current episode of depression \n\n Patients who are unlikely to be reliable and compliant with study procedures \n\n Patients who are not fluent in Norwegian", - "brief_summary": "Funding: An investigator-initiated trial funded by H. Lundbeck AS.~Study design: Prospective, randomised, placebo-controlled parallel-group multicenter study.~Aim: To investigate efficacy and side effects (especially mood switches) of escitalopram,a selective serotonin reuptake inhibitor, in the acute and maintenance treatment of bipolar depression.~Hypotheses:~Escitalopram, given in addition to mood stabilising medications, is significantly more efficacious, measured by response and remission rates than placebo in bipolar depression (the acute phase study).~Continuation therapy with escitalopram gives significantly longer mean time to depressive relapse and fewer depressive relapses compared to placebo (the continuation study).~The incidence of mood switching (defined as development of mixed episodes, mania, or hypomania according to DSM-IV criteria) do not differ significantly between escitalopram and placebo in either the acute or the continuation phases.~Patients: In- and outpatients receiving care in the specialised psychiatric services of Western Norway. The population is intended to be representative of the patients treated for bipolar depression in ordinary specialist care. Patients must have a MADRS score of at least 20 at baseline. Patients with ongoing substance abuse or dependence, organic mental illness, and non-affective psychotic symptoms are excluded.~Medication: Escitalopram 10-20 mg daily or placebo in addition to mood stabilisers. The dose of mood stabilisers must have been constant for the last six weeks prior to randomisation.~Method: Phase 1 is a eight-week acute treatment trial with six clinical assessments. Patients treated with escitalopram who have not responded after eight weeks (defined by at least 50% reduction of MADRS score compared to baseline) leave the study. Placebo non-responders are treated openly with escitalopram and repeat phase 1. Responders are re-randomised to 32 weeks of maintenance treatment (phase 2). Phase 2 has nine clinical assessments. Patients who develop hypomania, mania or depressive episodes (defined as episodes meeting DSM-IV criteria for Major Depressive Episode with MADRS scores of at least 20 points) leave the study in this phase. Patients leaving the study prematurely will be offered alternative treatment.", - "NCTID": "NCT00464191" - }, - { - "brief_title": "Gao Bipolar Spectrum Lithium/Quetiapine Study", - "phase": "Phase 4", - "drugs": "['Lithium', 'Quetiapine']", - "drugs_list": [ - "Lithium", - "Quetiapine" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "42.0", - "inclusion_criteria": "inclusion criteria: \n\n Able to provide informed consent before beginning any study-specific procedures \n\n Male and female patients at least 18 years of age \n\n Meets Diagnostic and Statistical Manual -IV criteria for BPI, BP II, or National Comorbidity Survey-R criteria for sub-threshold BP with or without symptoms, in need of medication adjustment(s) \n\n Willing to be randomized to either Lithium or Quetiapine \n\n If a sexually active female of childbearing potential, be using a reliable method of contraception, such as oral contraceptive or long-term injectable or implantable hormonal contraceptive, double-barrier methods (e.g. condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation \n\n Women with reproductive potential must have a negative urine pregnancy test \n\n ", - "exclusion_criteria": ": \n\n Unwilling to comply with study requirements \n\n Patients who have had severe adverse reaction to Lithium or Quetiapine \n\n Patients who require inpatient care \n\n Drug/alcohol dependence requiring immediate acute detoxification \n\n Pregnancy as determined by serum pregnancy test or breastfeeding \n\n History of nonresponse to Lithium at doses >900 mg \u22658 wks or to Quetiapine at doses of at least 300 mg/d \u2265 8 week for depression and at least 400-600 mg/d \u2265 4 wks for mania.", - "brief_summary": "This is a 4-month randomized open-label comparative safety, tolerability, and effectiveness trial of Lithium versus Quetiapine for subjects presenting in any phase of Bipolar who currently require a medication change for their illness. Stratified randomization will reduce bipolar type I , bipolar type II , or sub-threshold imbalance across cells. The enrollment goal is 60 subjects, over 24 months from initial regulatory approval. The primary outcome is the difference between lithium and quetiapine in the time to 'all cause' medication discontinuation.", - "NCTID": "NCT01526148" - }, - { - "brief_title": "Far Infrared Radiation Treatment for Bipolar Condition", - "phase": "Phase 1", - "drugs": "['Far infrared']", - "drugs_list": [ - "Far infrared" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "3.0", - "inclusion_criteria": "inclusion criteria: \n\n Persons with Bipolar Condition, Depression, Anxiety, Stress and Insomnia \n\n ", - "exclusion_criteria": ": \n\n Persons with severe mental illness that are confined to mental hospitals etc. as defined by the USA Diagnostic and Statistical Manual of Mental Disorders (DSM) are excluded from this clinical trial.", - "brief_summary": "A preliminary study to determine the possibility of using far infrared radiation for the treatment of the Bipolar Condition", - "NCTID": "NCT00573196" - }, - { - "brief_title": "An fMRI Study on Temporal Discounting in Bipolar Disorder", - "phase": "", - "drugs": "['fMRI Scanning']", - "drugs_list": [ - "fMRI Scanning" - ], - "diseases": "['Bipolar Disorder', 'Suicidal Ideation', 'Depression']", - "diseases_list": [ - "Bipolar Disorder", - "Suicidal Ideation", - "Depression" - ], - "enrollment": "28.0", - "inclusion_criteria": "inclusion criteria: \n\n Meets DSM-IV criteria for BD I and II current depressive episode \n\n Able to give written informed consent \n\n Age > to 18 years and < 65 years \n\n Currently suicidal as defined by a MADRS suicide item score of > 3 or previous history of serious suicidal ideation that required hospitalization. \n\n All subjects need to have normal hearing and normal/corrected-to-normal vision. \n\n ", - "exclusion_criteria": ": \n\n Medical illness or non-psychiatric medical treatment that would likely interfere with study participation \n\n Neurologic disorder, previous ECT, or history of head trauma (i.e. known structural brain lesion potentially confounding MRI results) \n\n Substance abuse within the past 3 months or current substance dependence (confirmed by MINI) \n\n Left-handedness \n\n Contraindications to MRI (metallic implants, claustrophobia, etc.) \n\n Subjects who need urgent psychiatric care requiring hospitalization (evaluated by clinicians).", - "brief_summary": "The investigators propose to explore the link between bipolar disorder, anxiety, and suicide by investigating intertemporal discounting in depressed, suicidal patients with bipolar I and II disorder who have various levels of anxiety. The investigators will determine the effect of anxiety on their intertemporal discounting (small rewards now compared to larger rewards later) in a decision-making paradigm and investigate the associated functional neuroanatomy using functional magnetic resonance imaging (fMRI).", - "NCTID": "NCT02323763" - }, - { - "brief_title": "Effectiveness of Lithium and Valproate in Treating High-Risk Bipolar Disorder", - "phase": "Phase 1", - "drugs": "['Lithium', 'Valproic acid']", - "drugs_list": [ - "Lithium", - "Valproic acid" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "98.0", - "inclusion_criteria": "inclusion criteria: \n\n Current major depressive episode or mixed episode \n\n Bipolar disorder \n\n History of suicidal behavior \n\n ", - "exclusion_criteria": ": \n\n Requires detoxification from alcohol or other substances \n\n Blood pressure greater than 160/90 mm Hg \n\n Active medical problems \n\n Requires long-term antipsychotic maintenance \n\n Becomes manic on mood stabilizers and antidepressants \n\n Contraindication to the use of lithium 1 or valproate (including failure to respond) \n\n Failure to respond to adequate trials of paroxetine, bupropion, and venlafaxine in the 2 years prior to study entry \n\n Failure to respond to adequate trials of olanzapine, haloperidol, and perphenazine in the 2 years prior to study entry \n\n Unable or unwilling to consent to treatment \n\n Pregnant or lactating", - "brief_summary": "This study will evaluate the effectiveness of two different mood stabilizing medications, lithium and valproate, in treating people with bipolar disorder and suicidal behavior.", - "NCTID": "NCT00563992" - }, - { - "brief_title": "Comparative Efficacy and Acceptability of Antimanic Drugs in Acute Mania", - "phase": "Phase 4", - "drugs": "['Lithium', 'Valproate', 'Oxcarbazepine', 'Quetiapine', 'Olanzapine', 'Ziprasidone']", - "drugs_list": [ - "Lithium", - "Valproate", - "Oxcarbazepine", - "Quetiapine", - "Olanzapine", - "Ziprasidone" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n with a diagnosis of bipolar I disorder, manic or mixed phase \n\n equal or more than 18 scores in Young Mania Rating Scale (YMRS) \n\n ", - "exclusion_criteria": ": \n\n Serious general medical illness \n\n pregnancy and lactation \n\n given long-acting antipsychotic drug within the last two month \n\n endocrine disease( e.g.Diabetes and thyrotoxicosis) \n\n given thyroxine therapy within the last three months or is being given hormone therapy \n\n sexually active and not using contraceptives", - "brief_summary": "Background:~Bipolar disorder is one of the most common mental illnesses affecting 1%-4% of the population, and one of the leading causes of worldwide disability. Mania is a condition of excessively elevated mood, characterizes bipolar disorder, and usually is a main cause of hospitalization. Mood stabilisers and antipsychotic drugs have long been the maintenance treatment of acute mania with and without psychotic symptoms. Though clinical trails have been demonstrated that these drugs are individually more effective than placebo in the relatively long term (e.g 4, 8 weeks). However, in the pragmatic practice, patient at acute mania urgently want to see the effectiveness, and psychiatrist under great pressure and are in great need to evaluate the very short-term effectiveness (e.g one week). If the first attempted antimanic drug fails, psychiatrist need the evidence that which medication should be to added on or switch to.~Objectives:~one main aim is to rank the short-term ( e.g.one and two week) effectiveness and acceptability of the common anti-mania drugs, including Lithium, Valproate, Oxcarbazepine, Quetiapine, Olanzapine, or Ziprasidone. Secondary aim is to investigate which medication to add on for non-responders or switch to.~Methods:~The study setting: it is expected that 120 subjects with a diagnose of DSM-IV bipolar I disorder will be recruited from Guangzhou Psychiatric Hospital, the earliest psychiatric hospital in the history of China established by Dr.J. G. Kerr in 1898.~Design:This study is a randomized, controlled trial. Participants with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of bipolar I disorder, manic or mixed episode will be randomly assigned to a treatment of Lithium, Valproate, Oxcarbazepine, Quetiapine, Olanzapine, or Ziprasidone. In the following conditions, participants will take another antimanic drug as a combination medication: 1) those who have a reduction in YMRS scores less than 25% after one week of treatment; 2) those who have a reduction in YMRS scores less than 50% after two weeks of treatment; or 3) those who have a increase in YMRS more than 30% at day 4. An antipsychotic (Quetiapine, Olanzapine, and Ziprasidone) will be added on for those who use lithium, Valproate or Oxcarbazepine as a first attempted medication; while Lithium, Valproate, or Oxcarbazepine will be added on for those who use an antipsychotic as a first attempted medication. Those participants who are recognized as non-response/partial response to two combined medications after 6 weeks of treatment will switch to Modified Electroconvulsive Therapy (MECT).~Measures: Primary outcome measures are change scores on the Young Mania Rating Scale (YMRS) and dropout rates. Secondary outcome measures include Clinical Global Impressions (CGI) Scale, Global Assessment Scale (GAS), Treatment Emergent Symptom Scale (TESS), and Brief Psychiatric Rating Scale (BPRS).~Response criteria: <25% reduction in YMRS scores or >=4 scores of CGI is defined as non-response. 25-49% reduction in YMRS scores from baseline as well as <=3 scores of Clinical General Impression (CGI) is recognized as partial response.>= 50% reduction in YMRS as well as 1 (very much improved) or 2 scores (much improved) of CGI is recognized as response. Remission is defined as a YMRS score <=12 and CGI score equal to 1 or 2.", - "NCTID": "NCT01893229" - }, - { - "brief_title": "Adjunctive Isradipine for the Treatment of Bipolar Depression", - "phase": "Phase 2", - "drugs": "['Isradipine', 'Placebo']", - "drugs_list": [ - "Isradipine", - "Placebo" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "2.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18-65 \n\n written informed consent \n\n meets Diagnostic and Statistical Manual-IV (DSM-IV) criteria (by Structured Clinical Interview for Diagnostic and Statistical Manual - IV -I/P (SCID)) for bipolar I disorder, current episode depressed \n\n Montgomery-Asberg Depression Scale (MADRS) score of at least 20 (i.e., moderate depression) and no greater than 34 (i.e., severe depression) at screen and baseline visit \n\n Young Mania Rating Scale (YMRS) score < 12 at screen and baseline visit \n\n currently treated with a lithium preparation (carbonate or citrate) at stable dose for at least 4 wks with level >0.6 and <1.0; and/or valproate at stable dose for at least 4 wks at level >60 and <110; and/or other atypical antipsychotic at stable dose for at least 4 weeks (at least minimum FDA-labeled dose) \n\n Caucasian by self-report - please see discussion below \n\n ", - "exclusion_criteria": ": \n\n Psychotic features in the current episode, as assessed by YMRS item #8 > 6 [where treatment guidelines urge use of antipsychotics that may confound isradipine results] \n\n felt by the study clinician to require inpatient hospitalization for adequate management (to include serious suicide or homicide risk, as assessed by evaluating clinician) \n\n 3 or more failed pharmacologic interventions in the current major depressive episode, excluding lithium/valproate/other atypical antipsychotic [response rates for these subjects is likely to be extremely low and would require a substantially larger-scale study to identify treatment effects] \n\n obsessive-compulsive disorder, or any diagnosis of a DSM-IV anxiety disorder where the anxiety disorder and not bipolar disorder is the primary focus of clinical attention \n\n current substance use disorder other than nicotine, by SCID-I/P \n\n a primary clinical diagnosis of a personality disorder, or comorbid diagnosis of antisocial or borderline personality disorder \n\n pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy) \n\n women who are breastfeeding \n\n other unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease, based on review of medical history, physical examination, and screening laboratory tests (this will include any clinical or laboratory evidence of hypothyroidism; if maintained on thyroid medication must be euthyroid for at least 1 month before Visit 1) \n\n history of hypertension or current treatment for hypertension \n\n current use of isradipine or history of anaphylactic reaction or intolerance to isradipine or any component of the preparation \n\n ECG abnormalities at entry: prolonged QTC interval or complete or incomplete bundle branch block \n\n patients who have taken an investigational psychotropic drug within the last 3 months \n\n patients receiving other excluded antipsychotics or antidepressants within 2 weeks prior to study entry \n\n patients requiring continued treatment with excluded medications (see below). \n\n Excluded medications: antidepressants, antipsychotics, and anticonvulsants (other than valproate), which could influence calcium signaling or impact mood; other calcium channel blockers; any other antihypertensive because of the risk of cause hypotension; any other drug known to interact with isradipine. Benzodiazepines or other sedative-hypnotic agents (e.g., zolpidem) may not be initiated after study entry; subjects requiring these agents will be removed from the study. Allowed: Sedative-hypnotic agents if dosage has been stable for 4 weeks prior to study entry; thyroid or estrogen replacement provided dosage has been stable for 3 months. Acceptable anticonvulsants include lamotrigine, valproate, gabapentin, topiramate, oxcarbazepine, carbamazepine.", - "brief_summary": "This study investigates the medication isradipine, which is currently approved by the FDA to treat high blood pressure, in the treatment of depression in bipolar disorder. Isradipine or placebo (contains no active medication) will be used as an add-on to lithium, valproate, and/or atypical antipsychotics for individuals currently experiencing a major depressive episode. Our hypothesis is that isradipine will be superior to placebo in improving depressive symptoms.", - "NCTID": "NCT01784666" - }, - { - "brief_title": "Quetiapine Fumarate (Seroquel) as Mono-Therapy or Adjunct to Lithium in the Treatment of Patients With Acute Mania in Bipolar Disorder", - "phase": "Phase 4", - "drugs": "['Quetiapine Fumarate', 'Lithium']", - "drugs_list": [ - "Quetiapine Fumarate", - "Lithium" - ], - "diseases": "['Acute Mania in Bipolar Disorder']", - "diseases_list": [ - "Acute Mania in Bipolar Disorder" - ], - "enrollment": "376.0", - "inclusion_criteria": "inclusion criteria: \n\n Provision of written informed consent before initiation of any study related procedures. Patients who are deemed incapable of providing informed consent maybe enrolled if written informed consent has been obtained from the patient's Legally Authorized Representative. \n\n Documented clinical diagnosis meeting the DSM-IV criteria for any of the following: \n\n 296.4X Bipolar I Disorder, Most Recent Episode Manic \n\n 296.0X Bipolar I Disorder, Single Manic Episode \n\n Have a YMRS score of at least 20 and a score of at least 4 on 2 of the following 4 YMRS items both at enrolment and at randomisation: Irritability, Speech, Content, and Disruptive/Aggressive Behaviour. \n\n Female patients of childbearing potential must have a negative urine pregnancy test at enrolment and be willing to use a reliable method of birth control, i.e., barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation, during the study. \n\n Be able to understand and comply with the requirements of the study, as judged by the investigator. \n\n ", - "exclusion_criteria": ": \n\n Manic episode judged to be either: \n\n the direct physiological consequence of a treatment or medical condition other than Bipolar disorder. \n\n the direct physiological effect of a substance of abuse; intoxication with hallucinogens, inhalants, opioids, or phencyclidine and related substances. \n\n the direct physiological effect of psychostimulant or antidepressant medication. \n\n Evidence of clinically severe or active disease, or a clinical finding that is unstable or that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect the study medication. \n\n History of seizure disorder, except febrile convulsions. \n\n Hospitalization period of 3 weeks or longer immediately prior to randomization for the index manic episode. \n\n Known history of intolerance or hypersensitivity to quetiapine or lithium, or to any other component in the tablets/capsules. \n\n Known lack of response to quetiapine or lithium, as judged by the investigator. \n\n Use of antipsychotic medication or mood stabilizer other than quetiapine and lithium at the day of randomisation (to be tapered to discontinuation between the enrolment visit and randomisation). \n\n Administration of a depot antipsychotic injection within 1 dosing interval (for the depot) before randomisation. \n\n Use of clozapine within 28 days prior to randomisation. \n\n Use of antidepressants during the enrolment period or within a period of 5 half-lives of the drug(s) prior to randomisation. \n\n Continuous daily use of benzodiazepines in excess of 4 mg per day of lorazepam, or the equivalent, during 28 days prior to randomisation. \n\n Use of drugs that induce or inhibit the hepatic metabolizing cytochrome 3A4 enzymes within 14 days before randomisation. \n\n Receipt of electroconvulsive therapy (ECT) within 28 days prior to randomisation. \n\n Clinically significant deviation from the reference range in clinical laboratory test results at enrolment, as judged by the investigator. \n\n An absolute neutrophil count (ANC) of <1.5X109/L. \n\n Treatment with quetiapine with a dosage of at least 50 mg/day at enrolment (Visit 1) \n\n Liver function test AST or ALT 2 times as the upper normal limit. \n\n A thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range of the laboratory used for sample analysis at enrolment, whether or not the subject is being treated for hypothyroidism. \n\n Known diagnosis of Diabetes Mellitus (DM) or fasting blood glucose level > the upper normal limit. \n\n Risk of transmitting human immuno-deficiency virus (HIV) or hepatitis B via blood or other body fluids, as judged by the investigator. \n\n ECG results considered to be clinically significant as determined by the investigator. \n\n Conditions that could affect absorption and metabolism of study medication. \n\n Patients who in the investigators opinion will require systematic psychotherapy (other than supportive psychotherapy) during the study period. \n\n Participation in another clinical study or compassionate use programme within 28 days prior to randomisation, or longer if locally required. \n\n Involvement in the planning and conduct of the study (applies to all AstraZeneca or staff at the investigational site). \n\n Previous enrolment or randomisation of treatment in the present study.", - "brief_summary": "To compare the efficacy and safety of quetiapine fumarate given as mono-therapy or adjunct therapy to lithium in the treatment of patients with acute mania in bipolar disorder. Patients with a documented clinical diagnosis of bipolar mania according to DSM-IV criteria (296.4X Bipolar I Disorder, Most Recent Episode Manic; 296.0X Bipolar I Disorder, Single Manic Episode) are required to have a YMRS total score of \u226520 at enrolment and randomisation", - "NCTID": "NCT00672490" - }, - { - "brief_title": "Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders", - "phase": "Phase 4", - "drugs": "['aripiprazole']", - "drugs_list": [ - "aripiprazole" - ], - "diseases": "['Bipolar Disorders', 'Metabolic Complication']", - "diseases_list": [ - "Bipolar Disorders", - "Metabolic Complication" - ], - "enrollment": "28.0", - "inclusion_criteria": "inclusion criteria: \n\n patients with bipolar disorders (I, II, NOS) diagnosed with DSM-IV criteria \n\n age between 18 and 65 \n\n Decisional capacity is adequate to provide informed consent or has an authorized appropriate surrogate decision maker. in a syndromal remission state at least for 2 months : CGI - BP \u2264 3 \n\n patients who have exhibited a clinically significant increase in body weight after starting the administration of their current antipsychotic (ie >7% weight gain) \n\n ", - "exclusion_criteria": ": \n\n diagnosis of eating disorder, substance abuse, and psychotic disorder \n\n history of neurological and medical illness \n\n pregnant or breast feeding women", - "brief_summary": "The primary goal of this study is to investigate metabolic changes and maintaining efficacy in stabilized patients with bipolar disorders who have pharmacologically induced weight gain.", - "NCTID": "NCT00845988" - }, - { - "brief_title": "Lamictal As Add on Treatment in Mixed States of Bipolar Disorder", - "phase": "Phase 4", - "drugs": "['Lamotrigine']", - "drugs_list": [ - "Lamotrigine" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "28.0", - "inclusion_criteria": "inclusion criteria: \n\n In order to be included in the study patient must meet criteria A, C, D, E, F, G plus any 1 of the 3 criteria listed in section B. \n\n A. Patients meeting DSM-IV diagnosis of bipolar disorder, I or II \n\n B. \n\n Patients meeting DSM-IV diagnostic criteria for a manic/hypomanic episode with the simultaneous presence of (or rapid alteration within minutes) of at least three DSM-IV depressive symptoms excluding psychomotor agitation or \n\n Patients meeting DSM-IV symptomatic criteria for a hypomanic/manic episode for a period of 2 days or longer, with the simultaneous presence of (or rapid alteration within minutes) of at least three DSM-IV depressive symptoms excluding psychomotor agitation or \n\n Patients meeting DSM-IV criteria for a depressive episode associated with at least three DSM-IV manic/hypomanic symptoms \n\n C.MADRS of \u226514 \n\n D.YMRS of \u2265 14 \n\n E. Age 13years to 75 years \n\n F. Male or female \n\n G. Outpatient \n\n ", - "exclusion_criteria": ": \n\n illness precluding the use of LAM \n\n Alcohol/drug dependence in the past one month \n\n patients with a history of a rash on LAM \n\n CNS neoplasms, demyelinating diseases, degenerative neurological condition or active CNS infection \n\n history of seizure, known EEG with frank paroxysmal activity, known CT of brain showing gross structural abnormalities, cerebral vascular disease by history or structural brain damage from trauma \n\n patients currently taking LAM", - "brief_summary": "To evaluate the efficacy and safety of LAM+existing regimen of mood stabilizer in the acute treatment of patients in a mixed state of bipolar disorder.~To evaluate the efficacy and of a combination of LAM+existing regimen of mood stabilizers in the maintenance treatment of patients with mixed state of bipolar disorder", - "NCTID": "NCT00223509" - }, - { - "brief_title": "Ketamine for Suicidality in Bipolar Depression", - "phase": "Phase 1; Phase 2", - "drugs": "['Ketamine', 'Midazolam']", - "drugs_list": [ - "Ketamine", - "Midazolam" - ], - "diseases": "['Suicidal Ideation', 'Bipolar Disorder', 'Major Depressive Episode']", - "diseases_list": [ - "Suicidal Ideation", - "Bipolar Disorder", - "Major Depressive Episode" - ], - "enrollment": "16.0", - "inclusion_criteria": "inclusion criteria: \n\n Bipolar depression with current major depressive episode (MDE). Participants may be psychiatric medication-free, or if on psychiatric medication, not responding adequately given current MDE with suicidal ideation. \n\n Moderate to severe suicidal ideation \n\n 18-65 years old \n\n Patients will only be enrolled if they agree to voluntary admission to an inpatient research unit at the New York State Psychiatric Institute (NYSPI) for infusion phase of treatment. \n\n Pre-menopausal female participants of child-bearing potential must be willing to use an acceptable form of birth control during study participation such as condoms, diaphragm, oral contraceptive pills \n\n Able to provide informed consent \n\n Subjects 61-65 years old must score 25 or higher on the Mini-Mental State Examination (MMSE) at screening \n\n ", - "exclusion_criteria": ": \n\n Unstable medical condition or neurological illness, including baseline hypertension (BP>140/90) or significant history of cardiovascular illness \n\n Significant ECG abnormality \n\n Pregnancy and/or lactation \n\n Current psychotic symptoms \n\n Contraindication to any study treatment \n\n Current or past ketamine abuse or dependence ever (lifetime); any other drug or alcohol dependence within past 6 months; suicidality only due to binge substance use or withdrawal \n\n Inadequate understanding of English \n\n Prior ineffective trial of or adverse reaction to ketamine or midazolam \n\n Opiate use greater than total daily dose of 20mg Oxycodone or equivalent during the 3 days pre-infusion", - "brief_summary": "This study is designed to compare the effectiveness of two medications, Ketamine and Midazolam, for rapidly relieving suicidal thoughts in people suffering from bipolar depression.~The first drug, ketamine, is an experimental antidepressant that early studies have shown may quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam, the comparison drug, is not thought to reduce depression or suicidal thoughts.", - "NCTID": "NCT01944293" - }, - { - "brief_title": "Prophylactic Effect of Lamotrigine Compared With Lithium in Bipolar Disorder", - "phase": "Phase 3", - "drugs": "['lithium or lamotrigine']", - "drugs_list": [ - "lithium or lamotrigine" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Age above 18 \n\n Inclusion is preceded by an affective episode requiring hospitalisation or outpatient drug treatment (index episode) which can be a manic episode (ICD-10 research criteria), a depressive episode of at least moderate degree (ICD-10 research criteria) or a mixed manic state (manic episode with at least additional three ICD-10 depressive symptoms except for difficulties with concentration or thinking, agitation or dyssomnia). The episode can be with or without psychotic symptoms including Schneiderian first-rank symptoms or bizarre delusions as long as the psychotic symptoms do not occur outside the affective episode. \n\n No more than 12 months may pass between the onset of the index episode (or admission if that is the case)and date of randomisation (in order to ensure a current risk of relapse as well as reliable psychopathological information). \n\n Besides the index episode, at least one previous episode must have occurred within the last five years which meets the criteria mentioned in point number two above. This episode may not necessarily have led to hospitalisation. Two episodes are separated by at least two months without significant symptoms or change in polarity (depression to mania/mixed mania or vice versa). \n\n At least one manic episode (or mixed manic episode) within the last 5 years. \n\n ", - "exclusion_criteria": ": \n\n Contraindications to the protocol drugs. \n\n Severe somatic disease, e.g. epilepsy, which may interfere with study treatment or effect evaluation. \n\n Pregnancy (or risk of pregnancy). \n\n Subject has prior to randomization received prophylactic treatment with lithium or lamotrigine conducted adequately in the sense of sufficient time and dose and ensuring compliance, and experienced a definite lack of prophylactic effect \n\n An ICD-10 diagnosis of abuse within the last year with a subsequent risk of protocol violation. Therefore, subjects with a secondary abuse can often be included in the study. \n\n Anticipated protocol violation for other reasons. \n\n No written informed consent from the subject can be obtained. \n\n The subject has previously been randomised in the study.", - "brief_summary": "The purpose of this study is to compare lamotrigine with lithium in the long term treatment of bipolar disorder in terms of new episode preventive potentials.", - "NCTID": "NCT00226135" - }, - { - "brief_title": "The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Bipolar Affective Disorders', 'Cyclothymic Disorder', 'Schizoaffective Disorder', 'Major Depressive Disorder', 'Dysthymic Disorder', 'Obsessive-Compulsive Disorder', 'Panic Disorder', 'Posttraumatic Stress Disorder', 'Premenstrual Dysphoric Disorder', 'Social Anxiety Disorder']", - "diseases_list": [ - "Bipolar Affective Disorders", - "Cyclothymic Disorder", - "Schizoaffective Disorder", - "Major Depressive Disorder", - "Dysthymic Disorder", - "Obsessive-Compulsive Disorder", - "Panic Disorder", - "Posttraumatic Stress Disorder", - "Premenstrual Dysphoric Disorder", - "Social Anxiety Disorder" - ], - "enrollment": "29.0", - "inclusion_criteria": "inclusion criteria: \n\n 18-40 year old female \n\n women currently taking Lithium or Sertraline \n\n ", - "exclusion_criteria": ": \n\n currently pregnant or breastfeeding \n\n concurrent use of any form of hormonal birth control, including oral contraceptive pills, Norplant or Depo-provera \n\n hepatic or renal disease \n\n irregular menstrual cycles.", - "brief_summary": "The aim of this study is to determine whether blood levels of lithium or sertraline are affected by different phases of the menstrual cycle and whether there is an effect on psychiatric symptoms. Subjects are seen for two visits: one visit during the luteal phase and one visit during the follicular phase of the menstrual cycle. On each visit, they will fill out a depression, anxiety and mania rating scale. Also at each visit a 20mL blood sample will be drawn to measure progesterone level and either a lithium or sertraline level, depending on which medication the patient takes. The primary hypothesis in this study is that blood levels of lithium and sertraline will be significantly lower in women during the luteal phase of the menstrual cycle than during the follicular phase. Examination will also be made of whether symptoms will increase in severity during the luteal phase as compared to the follicular phase. The investigators expect a negative linear association between symptom severity and blood level, i.e. expect symptom severity to worsen as blood levels of lithium or sertraline decrease.", - "NCTID": "NCT01385709" - }, - { - "brief_title": "A Pharmacokinetic Study of Lithium Before and During Topiramate Dosing in Bipolar Disorder Patients", - "phase": "Phase 1", - "drugs": "['topiramate', 'topiramate']", - "drugs_list": [ - "topiramate", - "topiramate" - ], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients meeting DSM-IV criteria for either Bipolar I, Bipolar II, Cyclothymic Disorder, or Bipolar Disorder NOS \n\n Patients on monotherapy treatment with lithium carbonate at steady state level for a minimum of two weeks prior to study treatment assignment \n\n Women are postmenopausal for at least 1 year, or surgically incapable of childbearing, or practicing an acceptable method of birth control (hormonal contraception, intrauterine device, or barrier with spermicide were acceptable) and not pregnant at baseline \n\n ", - "exclusion_criteria": ": \n\n Patients with a history of an acquired or hereditary neurologic disease, e.g., epilepsy or significant brain trauma \n\n Patients on depot medications, including but not limited to haloperidol, decanoate and Depo-Provera \n\n Patients who had taken acetazolamide, zonisamide, triamterene, dichlorphenamide, chronic antacids, or calcium supplements, or any medication associated with nephrolithiasis (kidney stone formation) in the month prior to beginning topiramate titration", - "brief_summary": "The purpose of this study is to determine the initial (after 1-week of maintenance dosing) and extended (after 3-weeks of maintenance dosing) effect of topiramate, at doses up to 600 mg/day, on the steady-state pharmacokinetics (absorption, distribution and excretion of the drug by the body) of lithium carbonate in patients with bipolar disorders.", - "NCTID": "NCT00986128" - } - ] - }, - { - "patient_id": "sigir-20148", - "patient": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", - "0": [ - { - "brief_title": "Sleep, Aging and Risk for Alzheimer's Disease", - "phase": "", - "drugs": "['Continuous positive airway pressure (CPAP)']", - "drugs_list": [ - "Continuous positive airway pressure (CPAP)" - ], - "diseases": "['Sleep Disordered Breathing', \"Alzheimer's Disease\"]", - "diseases_list": [ - "Sleep Disordered Breathing", - "Alzheimer's Disease" - ], - "enrollment": "235.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female subjects with normal cognition and >50 years of age will be enrolled. Younger subjects are not included as the risk for cognitive impairment is too low. Moreover, by selecting this age-range we minimize the possibility of including early-onset genetic forms of neurodegenerative diseases such as Alzheimer's disease and Frontotemporal Dementia. \n\n Normal subjects will be within normal limits on neurological and psychiatric examinations. All subjects enrolled will have both a Clinical Dementia Rating = 0 and Global Deterioration Scale < 3. \n\n All subjects will have had a minimum of 12 years education.The education restriction reduces performance variance on cognitive test measures and improves the sensitivity for detecting pathology and disease progression using the robust norms available at NYU School of Medicine. \n\n All subjects will have an informed family member or life partner interviewed to confirm the reliability of the subject interview. All subjects will agree to the MRI imaging, the lumbar puncture, apolipoprotein E (ApoE) genotyping and DNA banking \n\n ", - "exclusion_criteria": ": \n\n Diagnosis of any brain disease or MRI evidence of brain damage including significant trauma, hydrocephalus, seizures, mental retardation or other serious neurological disorder (e.g. Parkinson's disease or other movement disorders). Persons with silent cortical infarcts are excluded. Subcortical infarcts and white matter lesions are not exclusions. \n\n History of brain tumor. \n\n Any radiation or chemotherapy anywhere in the body in the past 3-years. \n\n Significant history of alcoholism or drug abuse. \n\n History of psychiatric illness (e.g., schizophrenia, mania, PTSD, or life long history of major depression). \n\n Hamilton Depression Scale >16 only with history of life long depressive episodes. Otherwise not excluded. \n\n Evidence of clinically relevant and uncontrolled cardiac, pulmonary, or hypothyroid or hematological conditions. Insulin dependent diabetes and/or history or treated hypertension are not an exclusion. Normal subjects with current levels of HbA1c >5.9% or diabetics >7.0% (American Diabetes Association, 2010) and/or current blood pressure levels >140/90 mm Hg (JNC on Prevention, Detection, Evaluation and Treatment of High Blood Pressure, 2003) will be advised to seek referral. \n\n Physical impairment of such severity as to adversely affect the validity of psychological testing. \n\n Hostility or refusal to cooperate. \n\n Any prosthetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for MRI imaging. \n\n History of a first-degree family member with early onset (before age 65) dementia. \n\n Medications adversely affecting cognition will result in exclusion. The excluded medications include: \n\n Antidepressants with anti-cholinergic properties. \n\n Regular use of narcotic analgesics (>2 doses per week). \n\n Use of neuroleptics with anti-cholinergic properties. \n\n Other medications with central nervous system anticholinergic activity. \n\n Use of Anti-Parkinsonian medications. \n\n At the baseline individuals taking physician ordered or off-label memory or other cognitive enhancing medications (e.g. cholinesterase inhibitors or memantine) are excluded. At the follow-up these medications are allowed. Also excluded at baseline are individuals taking physician ordered, but off-label memory enhancements. Individuals taking over the counter memory enhancing or protecting medications (e.g. ginkgo biloba, vitamins) are not excluded. \n\n Patients with significant physical changes (e.g. amputations or loss of sensory input) as these may affect the MRI blood flow measures.", - "brief_summary": "Our preliminary data show for in cognitively-normal elderly, that Sleep Disordered Breathing (SDB) is associated with the increase of cerebrospinal fluid (CSF) phosphorylated-Tau (P-Tau) and total-Tau (T-Tau), decreases in medial temporal lobe glucose uptake (FDG-PET) and volume (MRI) and progressive memory decline, all of which have been shown to be useful in predicting future dementia in older adults. These findings raise the question as to whether Alzheimer's disease (AD) tissue damage causes SDB in the elderly, or alternatively, if SDB acts as a risk factor for AD neurodegeneration. In the proposed study, we will investigate these mechanistic hypotheses in cognitively normal elderly by examining the longitudinal associations between SDB and cognitive decline, novel MR neuroimaging and CSF biomarkers for neurodegeneration; while our secondary goal is to launch a pilot treatment study to aid in interpreting the mechanistic hypotheses and to examine the effects of nasal continuous positive airway pressure (CPAP) on cognitive decline and neurodegeneration.", - "NCTID": "NCT01962779" - }, - { - "brief_title": "Cognitive Training for the Remediation of Functional Brain Health in HIV", - "phase": "", - "drugs": "['Plasticity-based Adaptive Cognitive Remediation (PACR)']", - "drugs_list": [ - "Plasticity-based Adaptive Cognitive Remediation (PACR)" - ], - "diseases": "['HIV - Human Immunodeficiency Virus', 'Cognitive Impairment']", - "diseases_list": [ - "HIV - Human Immunodeficiency Virus", - "Cognitive Impairment" - ], - "enrollment": "81.0", - "inclusion_criteria": "inclusion criteria: \n\n age 35 years or older; \n\n HIV infection for at least 1 year; \n\n able to communicate in English or French; \n\n capable of providing informed consent; \n\n easy access to the internet; \n\n EEG and MRI compatible \n\n ", - "exclusion_criteria": ": \n\n presence of dementia; \n\n life expectancy < 3 y; \n\n other neurological disorder including active opportunistic CNS infection; \n\n psychotic disorder; \n\n current substance dependence or abuse; and \n\n Hepatitis C requiring interferon therapy during the study period", - "brief_summary": "Cognitive deficits in HIV reflect degraded brain network functioning that may be amenable to remediation through cognitive training. In this sub-study, we will make use of Plasticity-based Adaptive Cognitive Remediation (PACR), which applies well-understood techniques derived from brain plasticity and implicit/procedural/perceptual learning to improve the speed and accuracy of information processing, with exercises that are designed to drive generalized improvements. Simultaneously, these exercises heavily engage neuromodulatory systems to re-establish their normal control over learning and memory. As an individual restores these degraded abilities through intensive procedural learning, the encoding of naturalistic information significantly improves, and all resulting declarative memory and cognitive functions based on the quality of that incoming information necessarily improve as well, leading to improvement that generalizes beyond the trained tasks.~A subset of 80 HIV+ individuals will undergo eight weeks of PACR to determine its feasibility and appropriateness for people with mild cognitive difficulties related to HIV infection. The results of this study are expected to be pivotal in generating data to create an optimal training program aimed at stabilizing or improving brain function in HIV infected individuals experiencing cognitive decline.", - "NCTID": "NCT02571504" - }, - { - "brief_title": "Train the Brain - Cognitive and Physical Training for Slowing Dementia", - "phase": "", - "drugs": "['Cognitive and Physical training']", - "drugs_list": [ - "Cognitive and Physical training" - ], - "diseases": "['Mild Cognitive Impairment', 'Dementia', 'Memory Disorders']", - "diseases_list": [ - "Mild Cognitive Impairment", - "Dementia", - "Memory Disorders" - ], - "enrollment": "160.0", - "inclusion_criteria": "inclusion criteria: \n\n Age between 65 and 89 \n\n Successful completion of primary school \n\n MCI, as Mini Mental State Examination score between 20 and 27 and confirmation through neuropsychological examination by a specialist, according to current guidelines. \n\n ", - "exclusion_criteria": ": \n\n Moderate/severe dementia \n\n Clinical signs of depressive disorder or other primary psychiatric disorders \n\n Neoplastic diseases \n\n Neurologic or musculoskeletal deficits barring neuropsychological examination or physical or cognitive training \n\n Severe heart disease \n\n End stage renal disease (eGFR<35 ml/min(1.73 m2) \n\n Severe chronic obstructive pulmonary disease (COPD) and/or respiratory failure \n\n Complicated or decompensated diabetes \n\n Overt peripheral artery disease \n\n Any inability to successfully complete a brain magnetic resonance scan \n\n Epilepsy, drug addiction \n\n Current acute diseases or recent head trauma", - "brief_summary": "Train The Brain is aimed at assessing the efficacy of cognitive and physical training in slowing progression to dementia in patients diagnosed with mild cognitive impairment (MCI).", - "NCTID": "NCT01725178" - }, - { - "brief_title": "Dopaminergic Enhancement of Learning and Memory in Healthy Adults and Patients With Dementia/Mild Cognitive Impairment", - "phase": "Phase 4", - "drugs": "['Levodopa']", - "drugs_list": [ - "Levodopa" - ], - "diseases": "['Healthy', \"Alzheimer's Disease\", 'Mild Cognitive Impairment']", - "diseases_list": [ - "Healthy", - "Alzheimer's Disease", - "Mild Cognitive Impairment" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria for patients with dementia: \n\n Patients: clinical diagnosis of AD or mild cognitive impairment \n\n primary language German \n\n ", - "exclusion_criteria": " for healthy subjects and patients with dementia/MCI: \n\n Known allergy to levodopa or tetrazine \n\n History of medication/drug abuse \n\n Acute nicotine withdrawal or > 15 cigarettes per day \n\n > 6 cups/glasses of coffee, caffeine drinks or energy drinks per day \n\n > 50 grams of alcohol per day \n\n Severe hypertonia (systole >160 mm Hg) \n\n Severe arteriosclerosis \n\n Diabetes, asthma, or glaucoma \n\n Severe hearing disability \n\n no focal brain lesions \n\n Premorbid depression or psychosis \n\n Medication with dopamine agonists or antagonists \n\n Parkinsonian symptoms", - "brief_summary": "This study aims to determine whether levodopa is effective in boosting learning and memory in healthy subjects and patients with dementia or Mild Cognitive Impairment.~We also examine in healthy subjects using functional magnetic resonance imaging which brain regions mediate improved learning after levodopa administration.", - "NCTID": "NCT00306124" - }, - { - "brief_title": "Prospective Research in Memory Clinics (PRIME)", - "phase": "", - "drugs": "['Current treatment practice of each participating physician']", - "drugs_list": [ - "Current treatment practice of each participating physician" - ], - "diseases": "['Dementia', 'Mild Cognitive Impairment']", - "diseases_list": [ - "Dementia", - "Mild Cognitive Impairment" - ], - "enrollment": "970.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of dementia under the DSM-IV criteria, or of Mild Cognitive Impairment, using the Peterson Criteria \n\n Living in the community (home, apartment or collective housing with nursing care available for less than 40 hours per week) \n\n Patient able to provide written informed consent, or provision of written informed consent by a legal guardian/proxy \n\n Availability of a caregiver willing to provide consent for required components of the study \n\n Fluent in English \n\n May be participating in a Phase IV or other post-marketing follow up study of an approved product for treatment of dementia \n\n ", - "exclusion_criteria": ": \n\n No concomitant life-threatening illness (a condition which is likely to interfere with the patient's ability to complete the study) \n\n Not unwilling or unable to complete the study \n\n Not concurrently participating in a clinical trial of an investigational drug (phase I, II or III) \n\n Unwillingness of patient or legal guardian / proxy to provide written informed consent \n\n Unwillingness of caregiver to provide written informed consent \n\n For patients with diagnosis of mild cognitive impairment: current or previous treatment with any cholinesterase or memantine", - "brief_summary": "The purpose of the PRIME Study is to examine the current management and outcomes of patients with mild cognitive impairment or dementia. Approximately 4500 patients will be enrolled in this disease registry across 12 sites in Australia. Clinical, treatment, health status and economic data will be acquired over 3 years. The study will identify the relationships among demographic variables, prognostic features, geographic setting, treatment options and clinical, economic and health status (activities of daily living and caregiver impact) outcomes.", - "NCTID": "NCT00297271" - }, - { - "brief_title": "How the Loss of Dopamine and Dopamine-Restoring Medicines Affect Movement Performance", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Parkinson Disease']", - "diseases_list": [ - "Parkinson Disease" - ], - "enrollment": "133.0", - "inclusion_criteria": "inclusion criteria: \n\n We will only include PD patients with a stable clinical response to L-DOPA and DAergic agents. \n\n We will only recruit patients with early or mild-to-moderate PD (score on Hoehn & Yahr scale 148 less than 3). \n\n To obtain a homogeneous group, the PD cohort will comprise only non-demented, non-depressed, with parkinsonian symptoms and signs primarily akineto-rigid. \n\n If resting tremor is present, only patients with mild or moderate tremor (UPDRS tremor ratings 1 or 2 in the right upper limb) will be included in the study. \n\n Our group of healthy volunteers will include the following age range: 21-30 years, 31-40 years, 41-50 years, 51-60 years, 61-70 years, and 70 years and over. \n\n Research subjects may be male or female and they must be right-handed. \n\n Pregnant women will not participate in the study. \n\n Research subjects will be asked to refrain from caffeine and nicotine for at least 12 hours and to abstain from alcohol at least 24 hours before the fMRI. \n\n ", - "exclusion_criteria": ": \n\n Subjects belonging to one of the following groups will be excluded from the study: \n\n Subjects with a familial history of PD. \n\n Patients with a marked resting tremor (score at the UPDRS scale above 3 in the right upper limb). \n\n Patients with a score at Hoehn & Yahr scale equal or above 3. \n\n Patients with progressive neurological disorders other than PD. \n\n Subjects with cognitive impairment (i.e., score on Mattis scale below 123/144). \n\n Subjects with significant mood disturbances (i.e., score on BDI scale above 10). \n\n Subjects with abnormal MRI findings at visual inspection (prominent normal variants such as mega cisterna or cavum septum pellucidum, signs of severe cortical or subcortical atrophy, brain tumors, vascular diseases, trauma or AVMs). \n\n Subjects with a history of significant medical disorders, or requiring chronic treatment with other drugs that cannot be stopped. \n\n Subjects with prior exposure to neuroleptic agents or drug use. \n\n Subjects with significant past and present history of hypertension, cardiovascular disease and diabetes mellitus. \n\n Subjects with severe orthopedic or rheumatologic pathology of the right upper limb. \n\n Subjects with past or present neuropsychiatric illness, head trauma with loss of consciousness, epilepsy, cerebro-vascular disease, past and present history of alcohol or substance abuse, including cigarettes, medical conditions that may alter cerebral functioning \n\n Subjects with cancer. \n\n Subjects who have pacemakers, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including heart valves and cochlear implants) or shrapnel fragments. \n\n Subjects incapable of giving an informed consent. \n\n Subjects with a positive pregnancy test. \n\n Subjects with pre-existing eyes condition. \n\n Subjects who are unable to tolerate being off of antiparkinsonian medications for 12 hours. \n\n Children will be excluded from the study because PD is infrequent before age 30.", - "brief_summary": "This study has two purposes: 1) to understand the effect of a decline of dopamine in the brain during normal aging and in patients with Parkinson's disease, and 2) to investigate how medicines used to treat Parkinson's disease improve movement performance in patients.~Patients with Parkinson's disease have difficulty performing precise finger movements, mainly because of a dramatic decrease of a substance called dopamine in parts of the brain. Medicines such as levodopa, which help restore dopamine levels, can greatly improve function; however, little is known about how these drugs work. In normal aging, dopamine decreases slightly in certain parts of the brain, but the importance of this decline is poorly understood. This study may provide new information about Parkinson's disease and normal aging that might lead to better treatment strategies.~Patients with mild to moderate Parkinson's disease and healthy volunteers 21 years of age and older may be eligible for this study. All participants must be right-handed. All candidates will be screened with a medical history and physical and neurological examinations, including memory tests and mood examination.~Brain function will be studied using functional magnetic resonance imaging (fMRI) study and positron emission tomography (PET). Participants may be asked to stop using medications that can affect the central nervous system, such as sleeping pills or drugs for depression or anxiety, for 1 week before each study visit. Patients with Parkinson's disease may also be asked to stop using antiparkinsonian medications at least 12 hours before each visit. In addition, all participants will be asked to abstain from alcoholic beverages at least 24 hours before the fMRI and PET scans, and from nicotine and caffeine for at least 12 hours before the scans.~Participants will have fMRI, which uses a strong magnetic field and radio waves to create images of the brain. The subject lies on a table in a tunnel-like cylinder (the scanner) for 1 to 2 hours, lying still for 5 to 15 minutes at a time. He or she can communicate with the technician or researcher at all times during the test through an intercom system. Scans will be done while the subject is at rest and while he or she is performing finger movements. The movements involve pushing five buttons on a box-each button every 3 seconds on average in a specific order. Patients with Parkinson's disease will be studied off- and then on- medications that restore the levels of levodopa in the brain.~Some participants may be asked to undergo a PET scan on a separate visit. A PET scanner is a doughnut-shaped machine similar in appearance to a CT (computed tomography) scanner. PET scans detect radioactivity used to provide information on brain activity. Before the test begins, subjects are given a dose of carbidopa-a medicine that increases the amount of levodopa in the brain. A catheter (thin, plastic tube) is then inserted into an arm or wrist vein, and a radioactive form of levodopa called 18Fluorodopa is injected through the catheter. A moldable plastic mask with large openings for eyes, nose, and mouth is placed on the face to help keep the head still during scanning. The total scan time is 2 hours or less.", - "NCTID": "NCT00040196" - }, - { - "brief_title": "Cohort Study to Investigate the Association Between Changes in Brain Volume and Postoperative Cognitive Dysfunction", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Postoperative Cognitive Dysfunction', 'Delirium', 'Dementia']", - "diseases_list": [ - "Postoperative Cognitive Dysfunction", - "Delirium", - "Dementia" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 65 years \n\n Elective major surgery \n\n Planned general anesthesia \n\n ", - "exclusion_criteria": ": \n\n Cardiac surgery \n\n Neurosurgery including carotid endarterectomy \n\n Preoperative Mini Mental State (MMS) Examination Score < 24 \n\n Previous pathological neuroimaging (if available) \n\n History of cerebral or cerebrovascular pathology \n\n Chronic use of psychiatric medication \n\n Alcohol or substance abuse \n\n A history of chronic pain unrelated to the planned surgery \n\n Any contraindication for MRI (e.g. pacemakers and other MR-incompatible metal implants) \n\n Claustrophobia \n\n Lack of informed consent", - "brief_summary": "Despite an ongoing controversy in the scientific literature, the link between anesthesia and dementia and/or cerebral atrophy remains unclear. Recent retrospective data suggests an association of surgery with a reduction in brain volume. With the present prospective cohort study, we would like to reproduce and verify these results, and investigate a possible association with the postoperative cognitive performance.~We will measure cerebral gray matter volumes in elderly patients before, 3 and 12 months after major non-cardiac surgery and determine cognitive functions at the same time.~Study hypothesis:~Surgery under general anesthesia in elderly patients is associated with a loss of gray matter.~The degree of cognitive dysfunction is associated with the loss of grey matter in brain areas relevant for cognitive functions.", - "NCTID": "NCT02045004" - }, - { - "brief_title": "Cognitive Impairment in Parkinson's Disease Categorised in Accordance to Motor Symptoms", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "[\"Parkinson's Disease\"]", - "diseases_list": [ - "Parkinson's Disease" - ], - "enrollment": "107.0", - "inclusion_criteria": "inclusion criteria: \n\n Idiopathic Parkinson's in accordance to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria, \n\n Born and raised in Denmark , \n\n >50 years \n\n ", - "exclusion_criteria": ": \n\n Cerebrovascular disease, \n\n Dementia not caused by Parkinson's Disease, \n\n Metabolism anomaly, \n\n Abuse of drugs, medication or alcohol, \n\n History of head injuries, \n\n Severe psychiatric disorder, excluding depression, \n\n Resident outside the region of Aarhus h) DBS -", - "brief_summary": "Background: Approximately 40% of patients with Parkinson's disease (PD) have cognitive impairments. There is a lack of consensus as to the extent to which psychiatric symptoms, depression, age at disease onset, disease duration, and medication is related to the type and severity of cognitive impairment. This discrepancy can in part be caused by the lack of distinction between patients with different motor symptoms and disease severity.~Objective: To identify the extent to which psychiatric symptoms, depression, age at disease onset, disease duration, and medication is related to the severity and type of cognitive dysfunction in patients with idiopathic PD categorized according to motor symptoms and disease severity.~Methods: the population of patients with PD in the old county of Aarhus is described on the background of medical records, and stratified in accordance to age, sex and cardinal symptoms. Through proportional allocation a sample of a minimum of 50 patients with PD is drawn from the population. The patients and 30 healthy matched controls will undergo comprehensive neuropsychological assessment including tests of language, memory, executive function, and visuospatial function. Furthermore, all participants will be screened for depression (Geriatric Depression Scale) and psychiatric symptoms (Neuropsychiatric Inventory and Symptom Checklist). The patients will be categorized in accordance with their motor symptoms via cluster analysis for the purpose of analyzing the effect of psychiatric symptoms, depression, and age of disease onset, disease duration, and medication on cognition.", - "NCTID": "NCT00476372" - }, - { - "brief_title": "Multimodal MRI Characteristics of Psychotherapy Response in Late Life Depression", - "phase": "", - "drugs": "['Problem Solving Therapy']", - "drugs_list": [ - "Problem Solving Therapy" - ], - "diseases": "['Major Depressive Disorder']", - "diseases_list": [ - "Major Depressive Disorder" - ], - "enrollment": "108.0", - "inclusion_criteria": "inclusion criteria: \n\n Current DSM-IV diagnosis of MDD, unipolar type, without psychotic features and 6 weeks minimum duration of current depressive episode. \n\n Moderate severity of depression using the Hamilton Depression Rating Scale (HDRS > 20). \n\n English speaking, male or female \n\n 65 years of age or older \n\n Good general health \n\n Able to give informed consent \n\n ", - "exclusion_criteria": ": \n\n Antidepressant use or psychotherapy within the past 6 weeks or electroconvulsive therapy within the past 6 months. \n\n Recent history (<6 months) of substance or alcohol abuse or dependence (DSM-IV criteria). \n\n Use of cognitive enhancing medications. \n\n Current diagnosis of Post-Traumatic Stress Disorder or other Axis 1 psychiatric disorder. \n\n Neurological diseases (e.g., Parkinson's disease, epilepsy, cortical stroke, Alzheimer's disease, traumatic brain injury) or dementia. \n\n History of surgical procedures affecting study outcomes. \n\n Contraindications for MR exam, i.e., no claustrophobia, no paramagnetic metal implants, able to fit in the MRI machine comfortably (BMI \u2264 38). \n\n Acute or uncontrolled medical illness or medication use impacting cognitive function.", - "brief_summary": "The specific focus of this study is to gather data regarding the effects of a psychological therapy known as Problem Solving Therapy (PST) on cerebral blood flow (CBF), cortical gray matter (GM) atrophy, subcortical white matter (WM) lesion burden, and measures of cognitive function in subjects with Late Life Major Depressive Disorder (LLD). This research goal will be achieved by recruiting 110 individuals over the age of 65 with LLD. The primary outcomes will be change in CBF, change in GM atrophy, change in WM lesion, change in cognitive function, and change in depression severity from baseline to the end of 12 weeks of PST.", - "NCTID": "NCT02440815" - }, - { - "brief_title": "Magnetic Resonance Imaging to Detect Brain Damage in Patients With Multiple Sclerosis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Multiple Sclerosis']", - "diseases_list": [ - "Multiple Sclerosis" - ], - "enrollment": "50.0", - "inclusion_criteria": "PATIENT inclusion criteria: \n\n Diagnosis of relapsing remitting or secondary progressive with superimposed relapses MS. \n\n Age between 18 and 60, inclusive. \n\n EDSS between 0 and 6.5. \n\n Receiving treatment with Interferon beta (either 1a or 1b) at fully tolerated dose for at least 6 months prior to enrollment and with evidence of clinical efficacy (i.e. reduction or absence of clinical relapses) at the time of the enrollment. \n\n PATIENT ", - "exclusion_criteria": ": \n\n Clinical relapse at the time of the enrollment or within the previous 3 months. \n\n Undergoing chronic therapy with any other immunomodulatory or immunosuppressive medication (excluding standard dosages of steroids intravenously/intramuscularly injected and orally taken for the treatment of relapses) besides Interferon within the past 6 months. \n\n Currently taking medications used for treatment of cognition/fatigue such as Donepezil (Aricept), Modafinil (Provigil), Amantadine, or other drugs that may act as temporary stimulants or depressants for the central nervous system. \n\n Currently taking other medications used for symptomatic relief that may affect cognition. The study neurologist will make the determination of eligibility. \n\n Clinically significant medical condition that, in the opinion of the investigator, would compromise patient's safety or affect his/her MRI (e.g., diabetes mellitus, chronic hypertension, severe anemia, kidney disease, heart disease [angina, arrhythmias, congestive heart failure]). \n\n Pregnancy or current breastfeeding. \n\n Previous eye surgery of any kind. \n\n Inability to provide informed consent. The ability of the patients in understanding all the aspects of the protocol will be judged by the means of a questionnaire. \n\n Permanent tattooed makeup (eyeliner, lip, etc.) or general tattoos. Subjects with tattoos will be excluded if those are in a dangerous location in the body or made with colors whose content in iron (e.g. dark blue or dark green) cannot be definitely ruled out by the Investigators. \n\n Any non-organic implant or any other device such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear, otologic, or ear implant, transdermal medication patch (nitro, hormones) that may cause problems if removed, even temporarily, any metallic implants or objects, body piercing(s), bone/joint pin, screw, nail, plate, wire sutures or surgical staples, shunt. \n\n Cerebral or other aneurysm clips. \n\n Shrapnel or other metal imbedded in the patient's body (such as from war wounds or accidents). \n\n Previous work in metal fields or with machines that may have left any metallic fragments in or near patients' eyes. \n\n A severe auto accident in the past if it is uncertain that any metal may still be imbedded in the patient's body. \n\n Any psychological contraindications for MRI (e.g., suffer from claustrophobia). This will be assessed at the time when the medical history will be collected. \n\n Any contraindications to having study procedures done. \n\n HEALTHY VOLUNTEER inclusion criteria: \n\n Age between 18 and 60. \n\n Vital signs are found within the normal range at the time of the screening visit. \n\n HEALTHY VOLUNTEER ", - "brief_summary": "This study will test the ability of magnetic resonance imaging (MRI) to detect damage in different parts of the brain in patients with multiple sclerosis and to see if cognitive problems in patients can be correlated with the presence of lesions or reduction in the size of certain part of the brain. Healthy subjects will also be studied to compare findings in patients with those of normal volunteers.~Healthy subjects and patients with multiple sclerosis who are between 18 and 60 years of age may be eligible for this study. Patients must not have severe clinical disability and must have been receiving and responding to Interferon beta for at least 6 months prior to enrollment. Candidates are screened with a medical history, physical examination, MRI and possibly evoked potential testing, which measures the nervous system response to visual, auditory and somatosensory stimulation.~Participants have two MRI scans within 1 week (inclusive of the one performed for screening). MRI uses a magnetic field and radio waves to obtain images of body tissues and organs. The scanner is a metal cylinder surrounded by a strong magnetic field. During the MRI, the subject lies on a table that can slide in and out of the cylinder. Participants will be tested with magnet strengths of 1.5 and 3 Tesla; the higher the Tesla, the greater the ability to see brain changes. Each scan may last up to 90 minutes. In addition to the MRI scans, participants undergo cognitive testing that measures memory and thought processes and complete forms that test and quantify fatigue level, stress, anxiety and depression", - "NCTID": "NCT00393588" - }, - { - "brief_title": "Retinal Neurodegenerative Signs in Alzheimer's Diseases", - "phase": "", - "drugs": "['Ophthalmological examination & Questionnaire']", - "drugs_list": [ - "Ophthalmological examination & Questionnaire" - ], - "diseases": "[\"Alzheimer's Disease\"]", - "diseases_list": [ - "Alzheimer's Disease" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n inclusion criteria for AD cases: \n\n Diagnosis of probable AD, defined according to the NINCDS-ARDRA criteria51 \n\n Light to moderate severity of the disease, defined by a MMSE score >10 (global evaluation of cognition) \n\n Patient aged 50 years or more \n\n Patient benefiting from social insurance \n\n inclusion criteria for controls: \n\n Absence of suspicion of dementia, based on normal performance according to age and educational level at neuropsychological testing defined as: \n\n Free recall \u226517 and total recall \u226540 for the Free and Cued Selective Reminding Test (Grober and Buschke test 52) MMSE \u2265 norm for age and educational level (defined by mean - 1 SD) \n\n Isaac's set test \u2265 norm for age and educational level (defined by mean - 1 SD) \n\n Matched to age and gender of the cases \n\n Patient benefiting from social insurance \n\n ", - "exclusion_criteria": ": \n\n ", - "brief_summary": "A few studies suggest that patients suffering from neurodegenerative diseases (such a multiple sclerosis or Alzheimer's disease (AD)) show decreased thickness of the retinal nerve fiber layer (RNFL), indicating axonal degeneration. High-definition spectral domain optical coherence tomography (SD-OCT), performed without radiation in a few seconds per eye, offers a precise and standardized estimation of this parameter, which could constitute a biomarker for cerebral axonal degeneration. These RNFL deficits might even be the earliest sign of AD, prior to damage of the hippocampal region that impacts memory.~Besides, some associations of AD with some degenerative diseases of the eye (glaucoma, microvascular abnormalities, age-related macular degeneration (AMD)) have also been reported.~It therefore seems interesting to determine whether RNFL thickness, and other ocular parameters, may give some indications for a better detection of AD and cognitive decline in the elderly.", - "NCTID": "NCT01555827" - }, - { - "brief_title": "Study of Neurological Complication After Radiotherapy for High Grade Glioblastoma", - "phase": "", - "drugs": "['brain radiotherapy']", - "drugs_list": [ - "brain radiotherapy" - ], - "diseases": "['Leukoencephalopathy']", - "diseases_list": [ - "Leukoencephalopathy" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n - diagnosis of glioma (stage 3 to 4) \n\n both genders \n\n age > 18 years \n\n treatment by radiotherapy and chemotherapy \n\n clinical monitoring post radiotherapy in Neurology Department, Piti\u00e9-Salp\u00eatri\u00e8re University Hospital and in the radiotherapy department of the Paul Strauss Institute. \n\n ", - "exclusion_criteria": ": \n\n - other neurological tumors and brain metastases \n\n psychiatric severe illness, including severe depression", - "brief_summary": "The survival time and the number of long time survivors after radiotherapy in brain cancer patients have increased for the last decades. Therefore the topic of late-delayed neurotoxic effects of this therapy gains more and more importance. Among these side effects, the main and most frequent one is the leukoencephalopathy, a diffused and progressive damage of the white matter characterized by myelin loss, loss of axons and vascular lesions. The incidence rate assessment, as well as the occurrence time, is based on retrospective studies with low numbers of patients, but seems to reach 30 to 50 % of the patients according to the follow-up. The risk seems to be increased during the first two years after the radiotherapy, but persists for decades.~To gain further insight in the radiation-induced leukoencephalopathy, the objective of this project is to study the onset and evolution of leukoencephalopathy in a 3-year prospective cohort of patients having undergone cerebral radiotherapy for glioma (stage 3-4), using specific cognitive tests, Magnetic Resonance Imagery (MRI) scans of the brain and predictive bio-markers of cognitive impairments.", - "NCTID": "NCT02544178" - }, - { - "brief_title": "Regional Cortical Cerebral Quantitative MRI Perfusion Correlation Neurocognition in Multiple Sclerosis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Multiple Sclerosis']", - "diseases_list": [ - "Multiple Sclerosis" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n established SPMS according to the McDonald criteria \n\n ", - "exclusion_criteria": ": \n\n Patients with a history of drug/alcohol abuse, a premorbid (pre MS) psychiatric history, a head injury with loss of consciousness and a concurrent physical disease requiring medical attention (eg. cardiovascular disease etc), MRI contraindication including implants, pacemaker, aneurysm clips and known renal impairment", - "brief_summary": "Multiple Sclerosis (MS) is a common disease affecting 1/1000 Canadians. Cognition impairment is reported in 40-65% of patients and is socially and functionally disabling. Although multiple sclerosis is widely regarded as a white matter disease, cortical disease burden is increasingly emphasized. Studies confirm that gray matter (GM) disease is grossly underestimated by conventional MRI. Although the cause for MS is unknown vascular impairment is implicated in nerve cell death. Several studies have shown perfusion abnormalities in the central GM and white matter (WM) structure. Severity of perfusion reduction correlates with lesion load, atrophy, MS subtype and disease duration. Further extent of cortical atrophy correlates with neurocognitive impairment. We hypothesize that cortical perfusion is a marker of cortical disease severity and correlates with neurocognitive impairment. To show this we will measure regional cortical perfusion and regional brain and WM lesion volumes in 26 predefined brain regions using a template developed for Alzheimer's disease. Regional perfusion will be correlated with neurocognitive tests validated for MS use. Patients will be divided into impaired and non impaired and perfusion compared controlling for known confounding factors. If confirmed cortical perfusion may be utilized as a surrogate marker of cognitive outcome in therapeutic studies.", - "NCTID": "NCT00812474" - }, - { - "brief_title": "EEG-Based Brain-Computer Interface Project for Individuals With Amyotrophic Lateral Sclerosis (ALS)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Amyotrophic Lateral Sclerosis', 'Neurodegenerative Disease', 'Motor Neuron Disease']", - "diseases_list": [ - "Amyotrophic Lateral Sclerosis", - "Neurodegenerative Disease", - "Motor Neuron Disease" - ], - "enrollment": "102.0", - "inclusion_criteria": "inclusion criteria: \n\n Medical Subjects: \n\n Be able to give consent themselves or via a legally authorized representative. \n\n Diagnosed with a neuromuscular disease and have limited ability to communicate. \n\n Be able to see visual cues such as targets or letters presented on the screen, and/or ability to hear auditory cues such as tones or words presented through speakers or earphones. \n\n Be able to understand and remember instructions concerning participation. \n\n Healthy control subjects: \n\n Be able to consent to give consent themselves or via a legally authorized representative. \n\n Be able to see visual cues such as targets or letters presented on the screen, and/or ability to hear auditory cues such as tones or words presented through speakers or earphones. \n\n Be able to understand and remember instructions concerning participation. \n\n ", - "exclusion_criteria": ": \n\n Individuals with cognitive impairments that would impact their ability to follow the instructions", - "brief_summary": "Amyotrophic lateral sclerosis (ALS) is a progressive neuromuscular condition characterized by weakness, muscle wasting, fasciculations and increased reflexes. Depending on the site of onset, individuals with ALS progressively lose control of their skeletal muscles; bulbar or the extremities. As symptoms worsen and spread, muscle atrophy becomes apparent and upper motor neuron symptoms such as spasticity complicate gait (in lower limb involvement) and manual dexterity (in upper limb involvement). The patients progress to a state of profound disability and have great difficulty in communicating; some may even be entirely locked in to their bodies. The capacity for simple communication could greatly improve their quality of life.~New technologies are giving people with disabilities alternate communication and control options. One such instrument is the EEG-based Brain-Computer Interface (BCI) which can provide both communication and control functions to those who have lost muscle control. By recording electroencephalographic (EEG) signals or brain waves from the scalp and then decoding them, the Wadsworth BCI allows people to make selections on a computer screen [i] In this study we will be investigating the feasibility of using EEG-based Brain-Computer Interface technology as a communication solution for individuals with ALS. The specific question addressed will be: Can individuals with ALS use the BCI for communication when they present with extreme loss of neuromuscular control and severe communication impairments? The goal of the project is to determine whether this device is a practical and realistic means for individuals with ALS to communicate. The study is intended to evaluate both the complexity of the system and the degree to which each participant will be able to communicate. Trials will consist of asking the subject to follow a series of simple instructions and complete certain tasks while using the BCI.~This study design requires that the individual live in the Philadelphia region. Please contact the Wadsworth Center of the New York State Department of Health and State University of New York at Albany directly if you reside outside of this area.", - "NCTID": "NCT00718458" - }, - { - "brief_title": "Developmental Trajectory of Brain Structural Connectivity and Cognitive Function From Childhood to Adulthood", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Brain Structural Connectivity', 'Cognitive Function']", - "diseases_list": [ - "Brain Structural Connectivity", - "Cognitive Function" - ], - "enrollment": "140.0", - "inclusion_criteria": "inclusion criteria: \n\n Ages 8-21 without current and past history of any psychiatric disorder and autistic symptoms. \n\n ", - "exclusion_criteria": ": \n\n Current symptoms or lifetime history of DSM-IV-TR diagnosis of attention-deficit/hyperactivity disorder, pervasive developmental disorder, schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorder, organic psychosis, bipolar disorder, depression, severe anxiety disorders or substance use. \n\n With neurodegenerative disorder, epilepsy, involuntary movement disorder, congenital metabolic disorder, brain tumor, history of severe head trauma, and history of craniotomy. \n\n With major systemic disease. \n\n Full-scale IQ < 80.", - "brief_summary": "Magnetic resonance imaging (MRI) is a premier modality to investigate structures and functions of human brain. In studies of children and adolescents, noninvasiveness of MRI makes it especially applicable. Developmental trajectory of gray matter volume and cortical thickness has been well studied in western countries. However, significant variability of brain structure has been reported between Chinese and Caucasian, and the variation may also exist in developmental trajectory of the brain. However, the maturation processes of neural fiber tracts in white matter are less understood. Diffusion tensor imaging (DTI), which has been frequently used to investigate the integrity of fibertracts in the literature, is limited in dealing with crossing fibers. Diffusion spectrum imaging (DSI) is a newly developed technique to improve the resolution of crossing fibers, and it is more suitable for detailed tractography assessment. In addition to establishing the template of brain structure (T1 and T2) and structural connectivity of our child, adolescent, and young adult population, the study has the following three aims.~To describe gender effect and developmental change of brain volume of different cortical and subcortical regions, thickness of cortex brain, and structural connectivity (e.g., frono-striatal, fronto-pareital, fronto-temporal and fronto-cerebeller tracts and superior longitudinal fasciculus II) across childhood through adolescent to adulthood;~To examine the gender effects and developmental change of attention, executive function and visual memory from childhood to adulthood and whether gender moderates these developmental changes; and~To correlate the structural connectivity and brain size and neuropsychological function within the same subjects.", - "NCTID": "NCT01677793" - }, - { - "brief_title": "Influence of Area of Brain Damage on Brain Reorganization After Chronic Stroke", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Central Nervous System Disease', 'Cerebrovascular Accident', 'Stroke']", - "diseases_list": [ - "Central Nervous System Disease", - "Cerebrovascular Accident", - "Stroke" - ], - "enrollment": "4.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients must be aged 18 or above with subacute (at least 3 months post stroke) thromboembolic or hemorrhagic strokes with impaired motor function in at least one of the limbs but capable of performing the required motor tasks. Assessment of the initial functional state will be taken at the initial visit at the NINDS Stroke Neurorehabilitation Clinic. Patients with additional stroke(s) during the length of the protocol will not be excluded from the study if the conditions stated in the ", - "exclusion_criteria": " are satisfied. \n\n ", - "brief_summary": "This study will examine how the brain rewires itself to make up for the lack of movement many people with stroke experience. It will try to determine if the rewiring differs depending on the location of the stroke and the amount of time since the stroke occurred. For some stoke patients, weakness may persist, while others recover completely after time. It is not known which parts of the brain are involved in the recovery of different types of stroke and if the type of stroke affects recovery.~People 18 years of age and older who have had subacute thromboembolic or hemorrhagic stroke more than 3 months before enrolling may participate in this study.~Participants come to the NIH Clinical Center three times every 2 years for up to 10 years. At the first visit, patients have a neurological examination and perform tests of motor abilities such as lifting small objects, turning cards, using a spoon, stacking checkers and lifting cans during a short period of time as rapidly as possible.~At the second visit, subjects have structural magnetic resonance imaging (MRI) scans of the brain. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. During the scan, the subject lies on a table that can slide in and out of the cylinder, wearing earplugs to muffle loud knocking noises associated with the scanning process. Total scan time is about 30 minutes~At the third visit, subjects perform some simple movement tasks during functional MRI (fMRI) scans. The procedure is the same as with structural MRI, except that subjects are asked to perform simple movement tasks in the scanner. Before the fMRI scans, electrodes are attached to the subject's arms and legs to monitor muscle activity (surface electromyography). Total scan time is about 1.5 hours. Movement tasks might include pinching a force-measuring instrument with the fingers, pressing different keys on a keyboard as fast as possible, inserting pegs into small holes on a board, lifting weights, flipping cards or similar activities.", - "NCTID": "NCT00474292" - }, - { - "brief_title": "Clinical Findings in General Paresis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['General Paresis']", - "diseases_list": [ - "General Paresis" - ], - "enrollment": "6.0", - "inclusion_criteria": "inclusion criteria: \n\n EEG MR \n\n ", - "exclusion_criteria": ": \n\n Serological test", - "brief_summary": "This is a study of the clinical and neuroimaging of general paresis. The investigators studied six patients with general paresis.", - "NCTID": "NCT00921648" - }, - { - "brief_title": "Focal Cortical Atrophy After Myocardial Internal Capsule", - "phase": "", - "drugs": "['Additional MRI']", - "drugs_list": [ - "Additional MRI" - ], - "diseases": "['Ischemic Stroke']", - "diseases_list": [ - "Ischemic Stroke" - ], - "enrollment": "21.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients of 18 to 90 years old. \n\n Subcortical stroke \n\n Achievement of the internal capsule, according to MRI \n\n Ability to perform MRI within 10 days after the onset of symptoms \n\n NIHSS over or equal 2 and < 20 \n\n Rankin Score over or equal 1 and \u2264 5 \n\n Written informed consent after information about the protocol, from patients or reliable person if patient is in incapacity to sign \n\n Affiliation to a social security scheme \n\n ", - "exclusion_criteria": ": \n\n Pregnant or nursing women \n\n Other cerebral lesion, concomitant or preexisting \n\n Concomitant disease causing unfavorable prognosis within 3 months after inclusion \n\n pre-existing psychiatric illness \n\n Alcoholism or other chronic intoxication \n\n Cortical localization of the infarction \n\n Patient in a coma, who cannot be examined and evaluated \n\n Patient intubated, ventilated, sedated \n\n Cerebral hemorrhage, intra-parenchymal and / or subarachnoid \n\n Persons protected by law (guardianship, curators and judicial protection) \n\n Contraindications to magnetic resonance examination: pacemaker, metal implants, neurostimulators, Clips neurosurgical wire sutures, staples, metal heart valves, ventricular bypass valve, metal workers, foreign eye, shrapnel, bullet , cochlear implants", - "brief_summary": "Primary purpose of the trial is to demonstrate the arisen of focal cortical atrophy, localized in the ipsilateral primary motor area, measured in mm, three months after infarction of internal capsule.~The patient is compared to himself between day zero to ten and three months.~The study hypotheses are:~A focal cortical atrophy of the ipsilesional primary motor area occurs after cerebral infarction of the internal capsule. It is measurable accurately and reproducibly by MRI at three months. Other brain areas within the voluntary motor system will also be explored (supplementary motor area, pre motor area).~This atrophy is correlated with achievement of pyramidal tract, assessed by the fractional anisotropy of its fibers.~This atrophy is correlated with disability at three months, assessed by Rankin score.", - "NCTID": "NCT01862172" - }, - { - "brief_title": "Women's Health Initiative Study of Cognitive Aging", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "2303.0", - "inclusion_criteria": "inclusion criteria: \n\n Enrolled in WHIMS \n\n At least 65 years old \n\n Not diagnosed with dementia \n\n ", - "exclusion_criteria": ": \n\n Women younger than 65 years of age \n\n Have dementia \n\n not enrolled in WHIMS", - "brief_summary": "The Women's Health Initiative Study of Cognitive Aging (WHISCA) is a two-armed, randomized, placebo controlled, clinical trial designed to assess the efficacy of postmenopausal hormone therapy (HT) on age related changes in specific cognitive functions.", - "NCTID": "NCT00631332" - }, - { - "brief_title": "Music Therapy to Restore Motor Deficits After Stroke", - "phase": "", - "drugs": "['Music-supported Therapy', 'home-based Music-supported Therapy', 'Conventional treatment']", - "drugs_list": [ - "Music-supported Therapy", - "home-based Music-supported Therapy", - "Conventional treatment" - ], - "diseases": "['Stroke', 'Paresis']", - "diseases_list": [ - "Stroke", - "Paresis" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Motor deficits of the upper limb after a first ever stroke \n\n A minimum punctuation of 11 in the subtest from the Motricity Index and Trunk Control Test which evaluates grip and pinch \n\n Less than 6 months from stroke \n\n Age between 30 and 75 years \n\n Right-handed \n\n ", - "exclusion_criteria": ": \n\n Inability to speak and understand the Spanish or Catalan language \n\n Major cognitive impairment affecting comprehension \n\n Neurological or psychiatric co-morbidity \n\n Substance abuse \n\n Formal musical education (i.e. professional musicians) \n\n Metallic implants incompatible with neuroimaging assessment \n\n Withdrawal from the study: \n\n Voluntary withdrawal of consent \n\n A new episode of stroke during the participation in the study", - "brief_summary": "Motor deficits are common after stroke, being one of the major causes of disability in this population. Because of the impact that motor impairments have in the life of patients and the associated financial costs, it is a health care priority to develop effective and efficient treatments to restore motor deficits. Music-supported therapy (MST) has been recently developed to enhance the use of the affected extremity after stroke.~In the present project, a new multidisciplinary approach (neurology, neuropsychology, music and cognitive neurosciences) will be undertaken in order to investigate the effectiveness of MST as a neurorehabilitation technique to restore the motor function in stroke patients. In addition, the complex pattern of reorganization of the sensorimotor system will be studied in order to provide information about the physiological mechanisms underlying the neurorehabilitation process.~A randomized controlled trial is proposed to compare for first time the effectiveness of MST (at the hospital and at home) compared to conventional treatment in subacute stroke patients suffering from motor deficits. Our hypothesis is that patients will experience a large improvement in the functional use of the affected arm due to the implementation of the MST program when compared to conventional treatment. We also expect to observe improvements in cognitive functions, mood and quality of life. Besides, we hypothesize that these amelioration in motor and cognitive domains will be accompanied by neuroplastic changes in the sensorimotor cortex and corticospinal tract.", - "NCTID": "NCT02208219" - }, - { - "brief_title": "Quantitative Automated Lesion Detection of Traumatic Brain Injury", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Traumatic Brain Injury']", - "diseases_list": [ - "Traumatic Brain Injury" - ], - "enrollment": "212.0", - "inclusion_criteria": "inclusion criteria: \n\n Control subjects from 18-50. \n\n Patients from 18-50 who have suffered TBI. \n\n ", - "exclusion_criteria": ": \n\n Substance abuse. \n\n Irremedial sensory deficits (blindness, deafness). \n\n Primary psychiatric disorder. \n\n Neurological disease unrelated to TBI.", - "brief_summary": "The investigators propose to develop quantitative automated lesion detection (QALD) procedures to identify brain damage following traumatic brain injury more accurately than is possible with a normal magnetic resonance imaging (MRI) scans. These procedures require about 1 hour of imaging in an MRI scanner. Subjects will also undergo about 2 hours of cognitive tests. The investigators will compare the results of the cognitive tests with those from MRI scanning to determine what brain regions are responsible for superior performance and for performance decrements.", - "NCTID": "NCT01022307" - }, - { - "brief_title": "Effects of Botulinum Toxin Injections in Patients With Hereditary Spastic Paraplegia", - "phase": "Phase 2; Phase 3", - "drugs": "['Botulinum Toxin Injections', 'Placebo Injections']", - "drugs_list": [ - "Botulinum Toxin Injections", - "Placebo Injections" - ], - "diseases": "['Hereditary Spastic Paraplegia']", - "diseases_list": [ - "Hereditary Spastic Paraplegia" - ], - "enrollment": "55.0", - "inclusion_criteria": "inclusion criteria: \n\n Age between 18 and 80 years \n\n Clinical diagnosis of Hereditary Spastic Paraplegia \n\n Ability to walk at least 10 meters: Assistive devices are permitted \n\n ", - "exclusion_criteria": ": \n\n Wheelchair bound patients \n\n Additional neurological symptoms that may significantly impact gait such as ataxia, polyneuropathy or dementia. \n\n Fixed tendon contractures \n\n Antecedents of allergy or adverse reaction to botulinum toxin \n\n Pregnancy or breastfeeding condition \n\n Mental retardation \n\n Dementia", - "brief_summary": "Hereditary spastic paraplegias constitute a heterogeneous group of diseases with the common predominant feature of spasticity of the lower limbs. The clinical picture is composed of difficulty walking, exaggerated deep reflexes, pathological reflexes such as the Babinski sign, sphincter disturbances and various degrees of weakness as well as sensory disturbances.~Spasticity is the symptom that provoques greater incapacity. Although there have been recent advances in the genetic and pathogenic characterization of SPG there is scarcity of therapeutic options. The Botulinum Toxin (BTx) is a well established treatment for movement disorders such as cervical dystonia, blepharospasm, and arm spastic following stroke.~Therefore, the investigators propose the execution of a randomized, double-blind, placebo-controlled, crossover study to evaluate the efficacy of the treatment with Btx over SPG patient's gait. The primary outcome measure will be gait velocity with the 10 meter walking test 8 weeks after injection. Each participant will be submitted to one injection session of Btx and one of placebo (consisting of sterile sodium chloride), each one separated by a period of 6 months. The primary and secondary outcomes will be evaluated by a blind investigator 8 weeks after each injection session.", - "NCTID": "NCT02604186" - }, - { - "brief_title": "Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease", - "phase": "Phase 2", - "drugs": "['leuprolide', 'testosterone']", - "drugs_list": [ - "leuprolide", - "testosterone" - ], - "diseases": "['Spinal Muscular Atrophy', 'Amyotrophic Lateral Sclerosis', 'Spinobulbar Muscular Atrophy']", - "diseases_list": [ - "Spinal Muscular Atrophy", - "Amyotrophic Lateral Sclerosis", - "Spinobulbar Muscular Atrophy" - ], - "enrollment": "40.0", - "inclusion_criteria": "PROTOCOL ENTRY CRITERIA: \n\n --Disease Characteristics-- \n\n Men aged 18 and over with motor neuron disease, i.e.: \n\n X-linked spinal and bulbar muscular atrophy (Kennedy's disease) \n\n Confirmed by androgen receptor, exon-1 mutation genotype \n\n Amyotrophic lateral sclerosis \n\n Spinal muscular atrophy \n\n Significant muscle weakness on manual muscle testing \n\n No prisoners \n\n No mental disability", - "exclusion_criteria": "", - "brief_summary": "OBJECTIVES:~I. Evaluate the effects of androgen suppression with leuprolide and androgen replacement with testosterone enanthate on muscle strength in men with Kennedy's disease or other motor neuron disease.", - "NCTID": "NCT00004771" - }, - { - "brief_title": "INfusion VErsus STimulation in Parkinson's Disease", - "phase": "Phase 4", - "drugs": "['Continuous intrajejunal infusion of levodopa-carbidopa', 'deep brain stimulation']", - "drugs_list": [ - "Continuous intrajejunal infusion of levodopa-carbidopa", - "deep brain stimulation" - ], - "diseases": "[\"Parkinson's Disease\"]", - "diseases_list": [ - "Parkinson's Disease" - ], - "enrollment": "66.0", - "inclusion_criteria": "inclusion criteria: \n\n Idiopathic Parkinson's Disease with bradykinesia and at least two of the following signs; resting tremor, rigidity, and asymmetry; \n\n Despite optimal pharmacological treatment, at least one of the following symptoms: severe response fluctuations, dyskinesias, painful dystonia or bradykinesia; \n\n A life expectancy of at least two years. \n\n ", - "exclusion_criteria": ": \n\n Age below 18 years \n\n Previous PD-neurosurgery (e.g., DBS, pallidotomy, thalamotomy); \n\n Previous CLI (through a PEG-tube or Nasal Jejuna| tube); \n\n Hoehn and Yahr stage 5 at the best moment during the day; \n\n Other severely disabling disease; \n\n Dementia or signs of severe cognitive impairment \n\n Psychosis; \n\n Current depression; \n\n Contraindications for DBS surgery, such as a physical disorder making surgery hazardous; \n\n Contraindications for PEG surgery such as interposed organs, ascites and oesophagogastric varices, or for Duodopa; \n\n Pregnancy, breastfeeding, and women of child bearing age not using a reliable method of contraception; \n\n No informed consent; \n\n Legally incompetent adults;", - "brief_summary": "Both Continuous intrajejunal Levodopa Infusion (CLI) and Deep Brain Stimulation (DBS) are accepted therapies for the treatment of advanced Parkinson's disease (PD). To date, no comparative studies have been executed. The INVEST study is an open label randomised controlled trial with cost-effectiveness as primary outcome. The main clinical outcome is quality of life; secondary outcomes are motor symptoms and neurological impairments, among others.", - "NCTID": "NCT02480803" - }, - { - "brief_title": "Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type", - "phase": "Phase 3", - "drugs": "['Aripiprazole (BMS-337039)', 'Placebo']", - "drugs_list": [ - "Aripiprazole (BMS-337039)", - "Placebo" - ], - "diseases": "['Dementia, Alzheimer Type']", - "diseases_list": [ - "Dementia", - "Alzheimer Type" - ], - "enrollment": "232.0", - "inclusion_criteria": "inclusion criteria: \n\n Non-institutionalized patients with a diagnosis of Alzheimer's disease as defined by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria with symptoms of delusions or hallucinations, which have been present, at least intermittently for one month or longer \n\n Mini Mental State Examination (MMSE) score of 6 to 24 points \n\n Patients capable of self locomotion or locomotion with the aid of an assistive device \n\n Patients with an identified caregiver or proxy \n\n For Extension Phase: \n\n Eligible patients were males and females who had completed the 10-week Acute Phase in either treatment group; had a Week 10 Total Score of \u2265 6 on the NPI; and were, in the judgment of the investigator, deemed suitable for participation in the long-term trial. \n\n Treatment beyond 140 weeks: \n\n All subjects who completed the extension phase of CN138-006 in any French Investigational Site may be considered eligible for entry until they are no longer receiving clinical benefit, per the investigator's judgment \n\n ", - "exclusion_criteria": ": \n\n Patients with an Axis I (DSM IV) diagnosis of: \n\n delirium \n\n amnestic disorders \n\n bipolar disorder \n\n schizophrenia or schizoaffective disorder \n\n mood disorder with psychotic features \n\n Patients with reversible causes of dementia \n\n Patients with psychotic symptoms continuously present since prior to the onset of the symptoms of dementia \n\n Patients with psychotic symptoms that are better accounted for by another general medical condition or by direct physiological effects of a substance \n\n Patients with a current major depressive episode with psychotic symptoms of hallucinations or delusions \n\n Patients with a diagnosis of dementia related to infection with the human immunodeficiency virus \n\n Patients with substance-induced persistent dementia \n\n Patients with dementia due to vascular causes, multi-infarct, head trauma, Pick's disease, Parkinson's disease, frontal or temporal dementia, Lewy body dementia, or any specific non-Alzheimer's type dementia \n\n Patients with seizure disorders \n\n Patients who have been refractory to neuroleptics used to treat psychotic symptoms in the past when treated for an adequate period with a therapeutic dose, unless permission is obtained from Bristol-Myers Squibb \n\n Patients who have met DSM-IV criteria for any significant substance use disorder within the 6 months prior to the start of screening", - "brief_summary": "The primary objective of the study is to compare the efficacy of aripiprazole with placebo in patients with psychosis associated with Alzheimer's dementia.", - "NCTID": "NCT01438060" - }, - { - "brief_title": "Combined Subthalamic and Nucleus Basalis Meynert Deep Brain Stimulation for Parkinson's Disease With Dementia", - "phase": "", - "drugs": "['Vercise deep brain stimulation', 'subthalamic nucleus (STN) stimulation', 'NBM stimulation', 'sham stimulation']", - "drugs_list": [ - "Vercise deep brain stimulation", - "subthalamic nucleus (STN) stimulation", - "NBM stimulation", - "sham stimulation" - ], - "diseases": "['Parkinson Disease', 'Dementia']", - "diseases_list": [ - "Parkinson Disease", - "Dementia" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Age at the time of enrollment: 35 - 75 years. \n\n Diagnosis of idiopathic PD with probable Parkinson's disease dementia (PDD) as defined by the MDS consensus guidelines (Emre et al., 2007) \n\n Mild to moderately severe dementia as defined by a Mini-Mental State Examination (MMSE) score of 10 to 24 \n\n Duration of bilateral idiopathic PD: \u22655 years of motor symptoms. \n\n Severity of bilateral idiopathic PD in the meds off state: modified Hoehn and Yahr stage \u22652. \n\n UPDRS subset III score of \u226530 in the meds off, stim off state. \n\n Levodopa must improve PD symptoms by \u226530% in a levodopa challenge test, as measured by UPDRS subset III score. \n\n PDD with a symptom onset at least 2 years after first symptoms of PD \n\n Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging systems and completing the motor diary) if mentally competent or, if incompetent, their legally authorized representatives. \n\n Able to understand the study requirements and the treatment procedures and to provide written informed consent before any study-specific tests or procedures are performed. If mentally incompetent, the legally authorized representative provides written informed consent \n\n ", - "exclusion_criteria": ": \n\n Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression. \n\n Any current drug or alcohol abuse. \n\n Any history of recurrent or unprovoked seizures. \n\n Any prior movement disorder treatments that involved intracranial surgery or device implantation. \n\n A history of neurostimulation intolerance in any area of the body. \n\n Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months. \n\n Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators. \n\n Pregnancy, breast-feeding, or lack of reliable contraception", - "brief_summary": "Phase 1 study evaluating the safety of combined bilateral subthalamic nucleus (STN) and basal nucleus of Meynert (NBM) stimulation in treating levodopa responsive motor symptoms of Parkinsonism and cognitive dysfunction in patients with advanced Parkinson's disease having mild to moderate dementia.", - "NCTID": "NCT02589925" - }, - { - "brief_title": "Oral Nutritional Supplementation in Amyotrophic Lateral Sclerosis (ALS) Patients", - "phase": "", - "drugs": "['Oral nutritional supplementation']", - "drugs_list": [ - "Oral nutritional supplementation" - ], - "diseases": "['Amyotrophic Lateral Sclerosis (ALS)']", - "diseases_list": [ - "Amyotrophic Lateral Sclerosis (ALS)" - ], - "enrollment": "229.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients \u226518 years of age, diagnosed with ALS (<2 months before inclusion) according to Airlie House criteria : definite, probable, or probable laboratory supported; \n\n Time between first symptoms and diagnosis less than 18 months \n\n Sporadic or familial cases \n\n Patient agreement to be followed in a given ALS centre during the duration of the study \n\n Patients with a loss of at least 1 point in 3 items of the ALSFRS-R rating scale or with a loss of at least 2 points in 2 items of the ALSFRS-R rating scale \n\n Patients who signed the informed consent form \n\n ", - "exclusion_criteria": ": \n\n Associated dementia or inability to understand the requirements of the protocol. \n\n No helper \n\n ONS already begun \n\n Artificial nutrition: enteral or parenteral nutrition \n\n Known hypersensitivity to components of ONS \n\n Absence of treatment with Riluzole (RILUTEK\u00ae) \n\n Patient under guardianship or curatorship \n\n Participation in another research protocol.", - "brief_summary": "The purpose of this study is to determine whether an early oral nutritional supplementation (ONS) in amyotrophic lateral sclerosis (ALS) patients is effective on the treatment of this rapidly progressive disease.", - "NCTID": "NCT02152449" - }, - { - "brief_title": "Enriched Environments for Upper Limb Stroke Rehabilitation", - "phase": "", - "drugs": "['conventional occupational therapy', 'video capture virtual reality']", - "drugs_list": [ - "conventional occupational therapy", - "video capture virtual reality" - ], - "diseases": "['Stroke']", - "diseases_list": [ - "Stroke" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria for patients wth stroke: \n\n Age 40-80 years \n\n sustained a single stroke between 3-24 months prio t study leading to upper limb paresis \n\n have at least Stage 3/7 arm control (mild to moderate motor deficits) on the Chedoke-McMaster Scale. \n\n <81 yrs old to minimize confounding effects of age-related changes in sensorimotor functions \n\n ", - "exclusion_criteria": " for patients wth stroke: \n\n other neurological or orthopaedic problems that may interfere with interpretation of results \n\n significant deficits in attention, constructional skills, neglect and apraxia \n\n shoulder subluxation, arm pain \n\n lack of endurance as judged by a physician \n\n undergoing other therapy, surgery or medical procedures within the study period. \n\n inclusion criteria for healthy control subjects: \n\n 1. Age 40-80 years \n\n ", - "brief_summary": "Stroke contributes significantly to the incidence of disabilities, with upper limb (UL) motor impairment being especially prevalent. Animal studies suggest that post-stroke motor recovery is largely attributable to adaptive plasticity in brain motor areas. While some environmental training factors contributing to plastic mechanisms have been identified in animals, translation of this knowledge to the clinical setting is insufficient. Optimal recovery may be related to both external (e.g., feedback type) and internal factors (e.g., cognitive ability, motivation). Clinically feasible methods for training are needed. Use of enriched virtual environments (VEs) may provide a way to address these needs. Outcome measures that best reflect recovery need to be identified since this is an essential step to evaluate the effect of novel training programs for UL motor recovery in stroke.~The research question is which clinical and kinematic outcome measures best reflect motor performance recovery after a targeted upper limb treatment intervention. Aim 1 is to compare changes in outcome measures recorded before and after an upper limb intervention in stroke subjects to motor performance in healthy subjects. Aim 2 is to determine motor performance between-group differences sample size is based on knowledge of expected outcome measure mean score differences between groups. Hypothesis. 1: Specific clinical and kinematic outcome measures will be sensitive to within-group (pre-post intervention training) changes. Hypothesis. 2: Specific clinical and kinematic outcome measures will be sensitive to between-group (healthy vs. patients in enriched vs. conventional intervention groups. Sixteen chronic stroke survivors and 8 age- and sex-matched healthy controls will participate. Patients will be matched on cognitive and motor impairment levels and divided into two groups. Using an single subject (A-B-A) research design, kinematics during two pre-tests, 3 weeks apart, will be recorded for test-retest reliability. Stroke groups will practice varied upper limb reaching movements (15 45-minute sessions in 3 weeks) in environments providing different motivation/feedback levels. Pre- and post motor performance evaluations will be done with clinical tests and a Test Task with specific motor performance requirements. A Transfer Task will also be recorded. By comparing data analysis methods (3-Dimensional (3D) analysis of different markers or placements), the investigators will identify which kinematic outcome measures best reflect motor improvement in post-test and follow-up sessions (retention).~The expected results are identification of two primary and two secondary outcome measures that reflect upper limb motor recovery and can distinguish between motor recovery and compensation. The results will be used to design a randomized control trial to determine the efficacy of VE-based treatment on arm motor recovery. The goal is to determine how extrinsic (environmental) and intrinsic (personal) motivational factors affect motor learning in stroke survivors with cognitive and physical impairment. Knowledge gained can also be used for rehabilitation of other neurological and orthopedic pathologies.", - "NCTID": "NCT01388400" - }, - { - "brief_title": "PRION-1: Quinacrine for Human Prion Disease", - "phase": "", - "drugs": "['Quinacrine']", - "drugs_list": [ - "Quinacrine" - ], - "diseases": "['Prion Disease']", - "diseases_list": [ - "Prion Disease" - ], - "enrollment": "160.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged 12 years or more, diagnosed with any type of human prion disease. \n\n ", - "exclusion_criteria": ": \n\n In a coma, or in a pre-terminal phase of disease such that prolongation of the current quality of life would not be supported \n\n Known sensitivity to quinacrine \n\n Been taking any other putative anti-prion therapy for less than 8 weeks", - "brief_summary": "PRION-1 aims to assess the activity and safety of Quinacrine (Mepacrine hydrochloride) in human prion disease. It also aims to establish an appropriate framework for the clinical assessment of therapeutic options for human prion disease that can be refined or expanded in the future, as new agents become available.", - "NCTID": "NCT00104663" - }, - { - "brief_title": "Does Long-Term Natalizumab (NTZ) Therapy Normalize Brain Atrophy Rates and Quality of Life (QOL) in Relapsing Remitting Multiple Sclerosis (RRMS)?", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Multiple Sclerosis']", - "diseases_list": [ - "Multiple Sclerosis" - ], - "enrollment": "85.0", - "inclusion_criteria": "inclusion criteria: \n\n 18-55 inclusive years of age at the time of informed consent \n\n Diagnosis of relapsing multiple sclerosis as defined by the 2010 revised McDonald criteria \n\n Currently taking Tysabri \n\n ", - "exclusion_criteria": ": \n\n Systemic steroid users \n\n comorbidities that could confound MRI outcomes", - "brief_summary": "Primary Aims: To determine how effective long term Natalizumab (NTZ) therapy is in slowing the progression of whole brain atrophy. Whole brain atrophy rates will be measured through magnetic resonance imaging (MRI) scans and compared between patients with Multiple Sclerosis (MS) who have been using NTZ for at least 2 years versus age and gender-matched healthy controls. The primary outcome will be whole brain atrophy rate measured as the percent change in brain volume (PBVC) over a two-year period.~Primary hypothesis:~The investigators hypothesize that long term (>2 years) NTZ therapy will slow the rate of whole brain atrophy in patients with Multiple Sclerosis (MS) (as measured by percent change in brain volume), reaching a whole brain atrophy rate similar to that of non-MS controls (a true disease activity free state).", - "NCTID": "NCT02588053" - }, - { - "brief_title": "A Clinical Demonstration of EEG Brain-computer Interface for ALS Patients", - "phase": "", - "drugs": "['BCI Device']", - "drugs_list": [ - "BCI Device" - ], - "diseases": "['ALS (Amyotrophic Lateral Sclerosis)']", - "diseases_list": [ - "ALS (Amyotrophic Lateral Sclerosis)" - ], - "enrollment": "27.0", - "inclusion_criteria": "Inclusion and ", - "exclusion_criteria": " \n\n Subject will be a veteran with El Escorial Lab Supported Probable or more definite diagnosis of ALS. \n\n Subject will have lost the ability to communicate either verbally or in writing (item 1 or item 4 on the ALS Functional Rating Scale-Revised (ALSFRS-R) score of 0, Appendix A) . \n\n Subject will be an adult (age >18). \n\n Subject will be living at home. \n\n Subject will be living within 100 miles of the participating study site. \n\n Subject will have corrected visual acuity of at least 20/80. \n\n Subject will have the ability to read and understand 6th grade English text on a computer screen. \n\n Subject will be able to indicate willingness and understanding of the consent form (using their existing method of communication). \n\n Subject will be able to identify one significant other. \n\n Subject will identify one system operator (person that agrees to be trained and set up the BCI). This person can be the significant other. \n\n Subject will be able to communicate non-verbally with their significant other, caregiver and system operator, and with study personnel. \n\n Significant other, caregiver and system operator will be able to indicate willingness and understanding of the consent form, be adults (age> 18) and expect to be with the subject for at least one year. \n\n Subject, significant other, caregiver and system operator will have life expectancy of at least one year. \n\n In the opinion of the BCI installation team, the home environment is physically and technologically conducive to BCI operation and use. \n\n Subject will demonstrate during the screening phase sufficient EEG interaction for the BCI to operate, i.e. classification rate of 70%. Classification rate is defined as the proportion of correct selections made during the daily calibration period of copy spelling. Copy spelling data refers to data collected while the patient attends to and selects specific predefined characters. \n\n Significant other, caregiver and system operator will demonstrate during the screening phase sufficient skill to manage the daily set-up and routine operations needed for the subject's basic operation of the BCI.", - "brief_summary": "The goal of this VA demonstration project is to show that the Brain-computer interface (BCI) technology is a clinically practical and important new communication and control option that can improve the lives of veterans with amyotrophic lateral sclerosis (ALS). The project will test four well-supported hypotheses: (1) that people with ALS who find (or will soon find) conventional assistive technology inadequate can and will use a BCI system for important purposes in their daily lives without close technical oversight, 2) they will continue and even increase this use throughout the period of the study, (3) that BCI use will improve their lives, and 4) BCI will improve the lives of their families and caregivers.", - "NCTID": "NCT00786032" - }, - { - "brief_title": "Preventive Effect of Proprioceptive Stimulation on Muscle Atrophy", - "phase": "Phase 1; Phase 2", - "drugs": "['proprioceptive stimulation']", - "drugs_list": [ - "proprioceptive stimulation" - ], - "diseases": "['Knee Arthritis']", - "diseases_list": [ - "Knee Arthritis" - ], - "enrollment": "34.0", - "inclusion_criteria": "inclusion criteria: \n\n patients waiting for knee replacement \n\n ", - "exclusion_criteria": ": \n\n neurologic disease", - "brief_summary": "Confinement to bed, which occurs in many pathological situations, induces a muscle atrophy and a loss of muscle strength. Muscle atrophy is associated to impaired performance in motor tasks, such as posture and locomotion, and is therefore a major cause of loss of autonomy. It requires a stay in follow-up and rehabilitation service, and thus lengthens the duration of hospitalisation.~Data underline the importance of afferent input integrity in the maintenance of muscle characteristics and postural control, and suggest that countermeasure programs based on the stimulation of proprioceptive inputs could be efficient to prevent muscle atrophy and falls. In particular, fundamental studies performed in rodents by the investigators laboratory have demonstrated that the adverse structural and functional adaptations which occur during muscle deconditioning can be counteracted through adequate physiological stimuli such as activation of proprioceptors. Based on this scientific expertise, the investigators aim is thus to prevent muscle atrophy and its functional consequences on posture and locomotion, following a surgical intervention in humans .~The investigators will develop a device allowing stimulation of foot and ankle proprioceptors. In order to facilitate the evaluation of its efficiency, the device will be tested on a selected population confined to bed during a post-operative period (knee replacement). It efficiency will be evaluated by means of three parameters: muscle force of ankle plantar flexor, muscle volume of lower limb muscles, functional outcome (gait and balance analysis).~The technique developed in the present project could bring benefits to patients confined to bed, or in elderly. Preventing or retarding development of muscle atrophy will beneficiate to health and quality of life of these patients. In addition, this device might allow to consider therapeutic strategies for prevention of atrophy in neuromuscular pathologies.", - "NCTID": "NCT01641627" - }, - { - "brief_title": "Use of Implanted Microstimulators for Decreasing Spasticity and Improving Motion Following Spinal Cord Injury", - "phase": "", - "drugs": "['Radio Frequency Microstimulator']", - "drugs_list": [ - "Radio Frequency Microstimulator" - ], - "diseases": "['Spinal Cord Injury at C5-C7 Level With Incomplete Lesion']", - "diseases_list": [ - "Spinal Cord Injury at C5-C7 Level With Incomplete Lesion" - ], - "enrollment": "1.0", - "inclusion_criteria": "inclusion criteria: \n\n an incomplete C6 ASIA C (Central Cord) spinal cord injury \n\n lower motor function impaired and suffers from significant spasticity (Ashworth scale 4) \n\n able to ambulate approximately 10-20 feet with a rolling walker and minimal assistance \n\n has sufficient endurance to complete at least two 20-minute therapy sessions per day \n\n cognitive abilities are intact \n\n ", - "exclusion_criteria": ": \n\n psychiatric diagnosis \n\n medical contraindications \n\n history of bleeding disorders \n\n allergy to anesthesia \n\n acute or progressive disease \n\n active implantable device", - "brief_summary": "The primary aims of this study are to determine the safety of the RFM System (Alfred Mann Foundation, Santa Clarita, CA) in a patient with incomplete SCI and the effect of the RFM system on lower limb strength and spasticity. The secondary aim is to analyze any improvement in the participant's mobility.", - "NCTID": "NCT00781833" - }, - { - "brief_title": "ETREAT Study on Effectiveness of Botulinum Toxin Type A Injections to Treat Post-stroke Upper and/or Lower Limb Spasticity", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Spasticity']", - "diseases_list": [ - "Spasticity" - ], - "enrollment": "110.0", - "inclusion_criteria": "inclusion criteria: \n\n Men and women \u2265 18-80 years. \n\n Poststroke limb spasticity. \n\n Patients who have suffered a stroke in the previous 6 months. \n\n Treatment goal has been previously agreed with the patient or their legal representative. \n\n Patients with clinically significant poststroke upper/lower limb spasticity, in whom it has been decided to perform multidisciplinary treatment with BoNT-A + rehabilitation. \n\n No previous treatment with BoNT-A. \n\n Patient is able to follow the protocol. \n\n Written informed consent. \n\n ", - "exclusion_criteria": ": \n\n Neuromuscular disease. \n\n Use of drugs that interfere with neuromuscular transmission. \n\n Any other condition that could interfere with rehabilitation or evaluation of the results. \n\n Diagnosis of spasticity not associated with stroke. \n\n Pregnant or nursing mothers. \n\n Prior participation in any other study in the 6 months before study entry", - "brief_summary": "The objective of this study is to evaluate the effectiveness of BoNT-A on functional improvement in patients with post-stroke upper and/or lower limb spasticity in the early stage of spasticity development, according to routine clinical practice.", - "NCTID": "NCT02275312" - }, - { - "brief_title": "University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol", - "phase": "", - "drugs": "['Bone marrow aspirate']", - "drugs_list": [ - "Bone marrow aspirate" - ], - "diseases": "['Graft Versus Host Disease (GVHD)', 'Acute Myocardial Infarction (AMI)']", - "diseases_list": [ - "Graft Versus Host Disease (GVHD)", - "Acute Myocardial Infarction (AMI)" - ], - "enrollment": "3.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 to 35 years \n\n Willingness to provide written informed consent \n\n ", - "exclusion_criteria": ": \n\n Presence of risk factors for or clinical evidence of Human immunodeficiency virus (type 1 and 2), Hepatitis B, Hepatitis C, Human T-lymphotrophic virus (type I and II), Human transmissible spongiform encephalopathy (including Creutzfeldt-Jakob disease) treponema pallidum, \n\n Presence of communicable disease risk associated with xenotransplantation. \n\n Test positive for Human immunodeficiency virus (type 1 and 2), Hepatitis B, Hepatitis C, Human T-lymphotrophic virus (type I and II), cytomegalovirus (CVM), West Nile Virus, treponema pallidum. \n\n Use of investigational drug within 30 days or 5 half lives which ever is longer. Use of investigational implanted device. \n\n History of malignancy. \n\n Pregnancy \n\n In the opinion of the hematologist or the investigator, a condition that compromises the ability of the donor to safely provide BM donation.", - "brief_summary": "The objective of this protocol is to use established standard criteria and methods for the collection of hMSC (human mesenchymal stromal cells) from healthy bone marrow donors. The hMSC collected from the donors will use to develop well-defined and reproducible cell banks. Standard manufacturing procedures and quality control testing methods will be used to characterize and evaluate the final cell product. After the cell banks are created, these cell products will be used in future translational or clinical research.", - "NCTID": "NCT01463475" - }, - { - "brief_title": "Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms", - "phase": "Phase 3", - "drugs": "['estradiol, 10 mcg']", - "drugs_list": [ - "estradiol", - "10 mcg" - ], - "diseases": "['Menopause', 'Postmenopausal Vaginal Atrophy']", - "diseases_list": [ - "Menopause", - "Postmenopausal Vaginal Atrophy" - ], - "enrollment": "309.0", - "inclusion_criteria": "inclusion criteria: \n\n Postmenopausal women whose last menstruation was at least two years previously", - "exclusion_criteria": "", - "brief_summary": "This trial is conducted in North America. The purpose of this study is to determine if Vagifem Low Dose is an effective and safe treatment for patients suffering from postmenopausal atrophic vaginitis.", - "NCTID": "NCT00108849" - } - ], - "1": [ - { - "brief_title": "Alzheimer's Disease and Related Disorders", - "phase": "", - "drugs": "['Drug intervention']", - "drugs_list": [ - "Drug intervention" - ], - "diseases": "[\"Alzheimer's Disease\", 'Gait Apraxia', 'Impaired Cognition']", - "diseases_list": [ - "Alzheimer's Disease", - "Gait Apraxia", - "Impaired Cognition" - ], - "enrollment": "700.0", - "inclusion_criteria": "inclusion criteria: \n\n All elderly patients from the University Memory Center of Angers University Hospital. \n\n Able to walk without any walking aid on 15 meters \n\n Mini-Mental Status Examination score > 10 \n\n Being affiliated to a social security regime \n\n ", - "exclusion_criteria": ": \n\n Mini-Mental Status Examination score \u2264 10 \n\n Subject suffering from pre-existing impellent disturbances \n\n History of cerebrovascular accident or other cerebro-spinal pathology \n\n Poor workmanship of the written or oral French language \n\n Use of walking aid such as walking frame with wheels or tricycle. \n\n Acute medical or surgical disease in the past 3 months \n\n Refusal to participate (or trustworthy person) \n\n Near visual acuity < 2/10", - "brief_summary": "The purpose of this study is to compare characteristics of gait and balance measured among patients with Alzheimer's disease or related disorders separated into 3 groups according to the stage of disease (i.e., pre-dementia, mild and moderate dementia stages); to determine the effects of anti-dementia drugs and vitamin D on cognitive motor abnormalities; and to establish a database at Angers University Memory Centre.", - "NCTID": "NCT01315704" - }, - { - "brief_title": "Brain Anatomy in Dystonia", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Dystonia', 'Healthy']", - "diseases_list": [ - "Dystonia", - "Healthy" - ], - "enrollment": "189.0", - "inclusion_criteria": "inclusion criteria: \n\n HEALTHY VOLUNTEERS: Healthy volunteers who consented to participate in the study and matched for age, sex, handedness with the group of patients with primary focal hand dystonia. \n\n PATIENTS: Patient with primary focal dystonia from our dystonia patient database who consented to participate in the study. This criterion will be established by the preliminary screening in the Human Motor Control Outpatient Clinic. \n\n ", - "exclusion_criteria": ": \n\n The following subjects will be excluded: \n\n Healthy volunteers with cognitive complaints, abnormal neurological exam or history of past neurological disease. \n\n Dystonia patients with the presence of a second neurological disease or condition; abnormal neurological findings on exam that are not related to primary focal dystonia. \n\n Subjects with past or present neuropsychiatric illness, head trauma with loss of consciousness, epilepsy, cerebro-vascular disease, migraine, past and present history of alcohol abuse, medical conditions that may alter cerebral structure. \n\n Subjects with abnormal MRI findings at visual inspection (prominent normal variants such as mega cisterna or cavum septum pellucidum, signs of severe cortical or subcortical atrophy, brain tumors, vascular diseases, trauma or AVMs). \n\n Subjects with any metallic objects within them just prior to MR imaging (cardiac or neural pacemaker, aneurysm clips [metal clips on the wall of a large artery], metallic prostheses [including heart valves and cochlear implants] or shrapnel fragments. Welders and metal workers are also at risk for injury and may not take part in the study because of possible small metal fragments in the eye of which they may be unaware. \n\n Subjects not capable of giving an informed consent. \n\n Women who are pregnant \n\n Children", - "brief_summary": "This study will use high-resolution magnetic resonance imaging (MRI) to look for subtle differences in brain anatomy between patients with focal hand dystonia (also called writer s cramp) and healthy normal volunteers. Patients with hand dystonia have prolonged muscle contractions that cause sustained twisting movements and abnormal postures. These abnormal movements often occur with activities such as writing, typing, playing certain musical instruments such as guitar or piano, or playing golf or darts.~Patients with focal hand dystonia and healthy volunteers will be enrolled in this study. Patients will be recruited from NINDS s database of patients with focal hand dystonia. Volunteers will be selected to match the patients in age, sex and handedness.~This study involves two visits to the NIH Clinical Center. The first visit is a screening visit, in which patients and volunteers will have a medical history, physical examination, neurological examination, and assessment of handedness. Women of childbearing age will be screened with a pregnancy test. Pregnant women are exclude from this study.~Those who join the study will return for a second visit for magnetic resonance imaging. MRI uses a magnetic field and radio waves to produce images of the brain. For the procedure, the participant lies still on a stretcher that is moved into the scanner (a narrow cylinder containing the magnet). Earplugs are worn to muffle loud noises caused by electrical switching of radio frequency circuits used in the scanning process. The scan will last about 45 to 60 minutes, at most. Some volunteers may be asked to return for a third visit to obtain a second MRI on a different scanner.", - "NCTID": "NCT00031369" - }, - { - "brief_title": "Safety and Effectiveness of Giving CPI-1189 to HIV-Infected Patients With AIDS Dementia", - "phase": "Phase 2", - "drugs": "['CPI-1189']", - "drugs_list": [ - "CPI-1189" - ], - "diseases": "['HIV Infections']", - "diseases_list": [ - "HIV Infections" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria \n\n You may be eligible for this study if you: \n\n Are HIV-positive. \n\n Are at least 18 years old. \n\n Have symptoms of AIDS dementia including forgetfulness, loss of concentration, slow mental processing, or a loss of muscle control. \n\n Have been on stable anti-HIV drug therapy for the past 6 weeks (if you are taking anti-HIV drugs). \n\n ", - "exclusion_criteria": " \n\n You will not be eligible for this study if you: \n\n Have certain serious medical conditions, such as a mental disorder or an opportunistic (AIDS-related) infection.", - "brief_summary": "The purpose of this study is to see if it is safe and effective to give CPI-1189 to patients with AIDS dementia.~Advanced HIV infection can cause AIDS dementia (brain damage due to HIV leading to loss of memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it down.", - "NCTID": "NCT00002414" - }, - { - "brief_title": "Direct Current Brain Polarization in Frontotemporal Dementia", - "phase": "Phase 1", - "drugs": "['Direct Current Polarization']", - "drugs_list": [ - "Direct Current Polarization" - ], - "diseases": "['Pick Disease of the Brain']", - "diseases_list": [ - "Pick Disease of the Brain" - ], - "enrollment": "6.0", - "inclusion_criteria": "inclusion criteria: \n\n -Six patients referred to the Cognitive Neuroscience Section, NINDS, with a clinical diagnosis of FTD confirmed here, will be selected to participate in the study. \n\n ", - "exclusion_criteria": ": \n\n Greater than 75 years of age. \n\n Presence of metal in the head other than dental hardware. \n\n Broken skin in the area of the stimulating electrodes. \n\n Any behavioral disorder that makes testing impossible. \n\n Children are excluded, as FTD is not a childhood illness.", - "brief_summary": "This pilot study will evaluate the effect of direct current (DC) electrical polarization of the brain on language, memory, reaction time, and mood in six patients with frontotemporal dementia (Pick's disease). There is no effective treatment available for cognitive impairment in patients with this condition. DC polarization sends a very weak current between two sponge pads placed on the head. In a previous study in healthy volunteers, DC polarization of the left prefrontal area of the brain increased verbal fluency, memory and attention, and motor reaction time in the study subjects.~Patients between 35 and 75 years of age with frontotemporal dementia who have been referred to NINDS's Cognitive Neuroscience Section for an existing protocol will be offered participation in this study. Candidates will be screened with a neurological examination to confirm the diagnosis of frontotemporal dementia.~Participants receive 40 minutes of DC polarization or sham polarization in each of two separate sessions. (No current is applied in the sham treatment). During the polarization, the patient rests quietly. Sponge pads that have been soaked in water are put on the left side of the head and above the right eye, and are held in place with elastic netting. Before the polarization and after about 20 minutes of polarization, patients undergo the following tests:~Language: Patients must say as many words beginning with certain letters as they can in 90 seconds.~Memory: Patients must remember a letter on a computer screen, and when the letter appears again, press the same letter on the keyboard.~Reaction time: Patients place pegs on a pegboard.~Mood: Patients place a mark on a line ranking how they feel.", - "NCTID": "NCT00077896" - }, - { - "brief_title": "Safety and Effectiveness of Botulinum Toxin in Elderly Patients With Dementia and Muscle Stiffness", - "phase": "Phase 2", - "drugs": "['Botulinum Toxin', 'Saline']", - "drugs_list": [ - "Botulinum Toxin", - "Saline" - ], - "diseases": "['Dementia', 'Paratonia']", - "diseases_list": [ - "Dementia", - "Paratonia" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Severe cognitive impairment (complete dependency in all activities of daily living (ADLs) \n\n Diagnosis of Alzheimer's disease, vascular dementia,or frontotemporal dementia \n\n Score> 3 on the paratonic assessment instrument, with paratonic rigidity in an arm(s) interfering in the provision of care \n\n ", - "exclusion_criteria": ": \n\n Alternate etiologies for increased tone \n\n Botulinum toxin 6 months preceding the study", - "brief_summary": "Aim of the study is to perform a pilot study to assess the impact of Botulinum toxin on muscle tone, and caregiver burden in individuals who are cognitively impaired and who are fully dependent.~The primary objective is to confirm proof of principle that paratonic rigidity and the consequences associated with it can be reduced with injection of Botulinum toxin injections resulting in reduced care-giver burden.~The secondary objectives are to determine optimal time points for evaluation of efficacy in this patient population and whether the time period is sufficient for washout of Botulinum toxin effect; determine most salient and sensitive outcome measures; identify obstacles in data gathering; and lastly, to determine feasibility of battery of assessments in this pilot study.", - "NCTID": "NCT02212119" - }, - { - "brief_title": "Balance Training in Parkinson's Disease Using Cues", - "phase": "Phase 3", - "drugs": "['Physicaltherapy']", - "drugs_list": [ - "Physicaltherapy" - ], - "diseases": "['Disturbance; Balance, Labyrinth', 'Parkinson\u00b4s Disease']", - "diseases_list": [ - "Disturbance; Balance", - "Labyrinth", - "Parkinson\u00b4s Disease" - ], - "enrollment": "42.0", - "inclusion_criteria": "inclusion criteria: \n\n Elderly \n\n The patient is able to provide informed consent. \n\n Definitive Idiopathic Parkinson's Disease as diagnosed by a Neurologist \n\n Hoehn and Yahr Stage 1-3 \n\n Able to ambulate without an assistive device \n\n On stable doses of Parkinson's medications prior to study onset \n\n ", - "exclusion_criteria": ": \n\n Mini Mental Status Exam (MMSE) < 24 \n\n Change in Parkinson's medications in the duration of study \n\n Uncontrolled orthostasis \n\n Symptomatic coronary artery disease \n\n Fracture of lower limb prior to study onset \n\n Other neurologic diagnosis \n\n Physical therapy before and during to study duration \n\n Significant camptocormia \n\n Any medical condition which the physician investigator determines would compromise the safety of exercise program for the subject.", - "brief_summary": "Verifying the efficiency of motor training associated with visual and auditory cues on the balance, and postural anticipatory and compensatory adjustments of patients with Parkinson's Disease (PD), for prevent fall rate in people with PD. It is a single blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of S\u00e3o Paulo University.", - "NCTID": "NCT01960985" - }, - { - "brief_title": "Exposure to Neurotoxins as Risk Factors for ALS", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['ALS']", - "diseases_list": [ - "ALS" - ], - "enrollment": "397.0", - "inclusion_criteria": "inclusion criteria: \n\n Cases were eligible to participate in the original study if (1) they had received a diagnosis of ALS within 2 years; (2) they lived in New England at least half the year; (3) they spoke English; (4) they were mentally and physically able to participate. The same inclusion criteria were used for controls. \n\n ", - "exclusion_criteria": ": \n\n Potential controls were excluded if they had a physician diagnosis of a neurodegenerative disease, polio, post-polio syndrome, or nondiabetic neuropathy. \n\n Pregnant women were excluded from both case and control groups.", - "brief_summary": "Chemicals called neurotoxins can harm the nervous system. Amyotrophic lateral sclerosis (ALS) is a progressive disease affecting movement. Researchers have studied many possible causes of ALS, including injury, diet, and exposure to chemicals, but these studies were inconclusive.~The purpose of this study was to determine whether exposure to lead or other neurotoxins can contribute to ALS. The study also evaluated lifestyle and dietary patterns. The study was completed in 1994-1996.~One hundred eighty-two participants took part in this study 110 patients with ALS and 72 who did not have ALS. Each completed a questionnaire concerning lifestyle, diet, and residential, job, and medical history. Participants contributed 50 cc of blood, used to measure lead, as well as clippings of their toenails, used to measure mercury and other metals. They then underwent an XRF test (an X-ray procedure) to measure the level of lead in their shinbones and knees. Genes related to ALS or susceptibility to lead exposure were also evaluated.", - "NCTID": "NCT00340301" - }, - { - "brief_title": "Vitamin B6, B12, Folic Acid and Exercise in Parkinson's Disease", - "phase": "", - "drugs": "['PD vitamin supplementation', 'PD exercise intervention', 'PD vitamin + exercise']", - "drugs_list": [ - "PD vitamin supplementation", - "PD exercise intervention", - "PD vitamin + exercise" - ], - "diseases": "[\"Parkinson's Disease\"]", - "diseases_list": [ - "Parkinson's Disease" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Medical clearance to perform an exercise tolerance test and training program. \n\n A diagnosis of PD at stage 2 on the Hoehn and Yahr scale. \n\n ", - "exclusion_criteria": ": \n\n A neurological condition other than PD/ \n\n Anyone who is currently taking any vitamin supplementation. \n\n Smokers. \n\n Anyone currently engaged in weight training.", - "brief_summary": "This experiment seeks to determine whether individuals with PD will benefit from vitamin B6 (pyridoxine hydrochloride), B12 (cyanocobalamin), and Folic Acid supplementation, whether they will benefit from a 6-week circuit training program, or whether they will benefit from a combination of the two interventions. The outcome variables will include: plasma homocysteine, GSH:GSSG ratio, cognitive function, balance, strength, functional activities, kinematic gait analysis, and a quality of life questionnaire.", - "NCTID": "NCT01238926" - }, - { - "brief_title": "Satisfaction Survey for Amyotrophic Lateral Sclerosis (ALS) Patients Comparing Rooms With and Without Assistive Technology", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Amyotrophic Lateral Sclerosis', 'Neurodegenerative Disease', 'Motor Neuron Disease']", - "diseases_list": [ - "Amyotrophic Lateral Sclerosis", - "Neurodegenerative Disease", - "Motor Neuron Disease" - ], - "enrollment": "5.0", - "inclusion_criteria": "inclusion criteria: \n\n In-patients with probable or definite ALS, ages 18 - 90, staying on the neurology floor of Hahnemann Hospital \n\n ", - "exclusion_criteria": ": \n\n In-patients who do not meet the criteria of the diagnosis of ALS.", - "brief_summary": "The purpose of this study is :~To assess the ALS patient's satisfaction related to a hospital stay on the neurology floor of Hahnemann Hospital.~To compare the reported satisfaction of those individuals who stayed in a standard hospital room with those who stayed in Room 1455. Room 1455 is a room specifically set up with assistive technology related to environmental controls for individuals with disabilities.~To look at frequency of use of the various pieces of adaptive equipment.", - "NCTID": "NCT00718107" - } - ], - "2": [ - { - "brief_title": "Mild Cognitive Impairment in Parkinson's Disease", - "phase": "Phase 4", - "drugs": "['Exelon Patch (rivastigmine transdermal system)', 'Placebo Patches']", - "drugs_list": [ - "Exelon Patch (rivastigmine transdermal system)", - "Placebo Patches" - ], - "diseases": "[\"Parkinson's Disease\", 'Mild Cognitive Impairment']", - "diseases_list": [ - "Parkinson's Disease", - "Mild Cognitive Impairment" - ], - "enrollment": "28.0", - "inclusion_criteria": "inclusion criteria: \n\n Participants must be experiencing symptoms of mild cognitive impairment; this will be determined by study personnel. \n\n Participants must be on a sable medication regimen for 2 months prior to starting the study (necessary dose adjustments during the study are acceptable). \n\n Participants are capable of giving informed consent supported by not meeting Parkinson's disease Dementia criteria; this will be determined by study personnel. \n\n ", - "exclusion_criteria": ": \n\n Active suicide ideation. \n\n Weighing less than 100 lbs (45 kgs). \n\n History of Deep Brain Stimulation surgery. \n\n Diagnosis of Dementia \n\n Taking certain types of medications may be an ", - "brief_summary": "Mild cognitive impairment, including difficulty with solving problems, planning, attention, or recalling information, can be a significant problem for individuals with Parkinson's disease. Even mild cognitive difficulties can lead to worse functioning, quality of life, depression, and difficulty for caregivers. Thus, ideally treatment at this stage would improve both cognitive symptoms and some of the other problems associated with these symptoms.~Despite the fact that mild cognitive impairment is a serious problem for Parkinson's disease patients little is known about how best to treat it. This study is a 24-week clinical trial to see if a Food and Drug Administration (FDA)-approved drug, the Exelon (rivastigmine) Patch, is useful in treating mild cognitive impairment in patients with Parkinson's disease. Currently, the Exelon (rivastigmine) Patch is FDA-approved for the treatment of mild to moderate dementia in Alzheimer and Parkinson's disease patients.", - "NCTID": "NCT01519271" - }, - { - "brief_title": "Assessment of Lesion Activity Analysis in the Avonex- Steroid Azathioprine (ASA) Study", - "phase": "", - "drugs": "['MRI']", - "drugs_list": [ - "MRI" - ], - "diseases": "['Multiple Sclerosis, Relapsing-remitting']", - "diseases_list": [ - "Multiple Sclerosis", - "Relapsing-remitting" - ], - "enrollment": "159.0", - "inclusion_criteria": "inclusion criteria: \n\n Enrolled into the 2-year, double-blind, placebo-controlled ASA study and entered 3 year extension study \n\n MRI was performed on all patients using a 1.5 T magnet \n\n ", - "exclusion_criteria": ": \n\n MRI images unable to be processed \n\n All 5 MRI time points not collected", - "brief_summary": "To examine short- and long-term value of appearance of new active lesions in predicting extent of cortical and subcortical deep gray matter (SDGM) atrophy over 5 years in ASA (Avonex- Steroid-Azathioprine)study.~To explore how accumulation of cortical and SDGM atrophy over 5 years differs with respect to the number of new active lesions or amount of disease activity, in early relapsing-remitting multiple sclerosis (RRMS) patients who did or did not develop sustained disability progression.~To examine the relationship between development of cortical and SDGM atrophy and regional likelihood of development of new active lesions over 5 years.", - "NCTID": "NCT01628315" - } - ] - }, - { - "patient_id": "sigir-20149", - "patient": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", - "0": [ - { - "brief_title": "Effect of Palifermin on Skin Tumors in Patients Undergoing Bone Marrow Transplantation", - "phase": "", - "drugs": "['Palifermin']", - "drugs_list": [ - "Palifermin" - ], - "diseases": "['Skin Rash']", - "diseases_list": [ - "Skin Rash" - ], - "enrollment": "7.0", - "inclusion_criteria": "inclusion criteria: receiving bone marrow transplant - \n\n ", - "exclusion_criteria": ": not receiving other growth factors \n\n -", - "brief_summary": "We are approaching you to participate in this study because you are taking Palifermin and the purpose of this study is to describe the effect of Palifermin on skin growth found on the body. Palifermin is a new synthetic growth factor (encourages skin cells to grow) specifically designed to protect the areas of the body (mouth and upper digestive tract) that are damaged by chemotherapy. The cells in these areas are rapidly dividing cells and so are killed by chemotherapeutic drugs. Palifermin is a drug that stimulates new cells in these areas to grow and therefore protects patients from some serious side effects of chemotherapy. These include mucositis or inflammation of the lining of the mouth and other organs resulting in difficulty swallowing, speaking and extreme pain in the mouth and upper digestive tract.~Skin cells are also known to respond to these types of growth factors like Palifermin, but unfortunately no studies have been done that look specifically at the effect of this drug on pre-existing skin lesions or the development of new skin lesions. We will be asking you if you have noticed any change in moles or other skin lesions that you have, and if you have noticed any new lesions. We will also be doing a full physical examination of the skin at regular intervals during the study to document the appearance of any new lesions or change in pre-existing ones.", - "NCTID": "NCT00610818" - }, - { - "brief_title": "Dose-Response Profile of A-101 in Subjects With Seborrheic Keratosis", - "phase": "Phase 2", - "drugs": "['A-101 Vehicle', 'A-101 (40) Topical Solution', 'A-101 (32.5) Topical Solution']", - "drugs_list": [ - "A-101 Vehicle", - "A-101 (40) Topical Solution", - "A-101 (32.5) Topical Solution" - ], - "diseases": "['Seborrheic Keratosis']", - "diseases_list": [ - "Seborrheic Keratosis" - ], - "enrollment": "172.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject is at least 18 years of age \n\n Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis \n\n Subject has 4 appropriate seborrheic keratosis target lesions, as defined below, on the trunk/extremities: \n\n Have a clinically typical appearance \n\n Be treatment na\u00efve \n\n Have a Physician Lesion Assessment (PLA) of \u22652 \n\n Have a longest axis that is \u22657mm and \u226415mm \n\n Have a longest dimension perpendicular to the longest axis that is \u22657mm and \u226415mm \n\n Have a thickness that is \u22642mm \n\n Be a discrete lesion \n\n Be, when centered in the area outlined by the provided 3cm diameter circular template, the only seborrheic keratosis lesion present \n\n Not be in an intertriginous fold \n\n Not be in an area where clothing, such as a bra, might cause physical irritation \n\n Not be pedunculated. \n\n If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an active form of birth control for the duration of the study \n\n Subject is non-pregnant and non-lactating \n\n Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of any target lesion or which exposes the subject to an unacceptable risk by study participation \n\n Subject is willing and able to follow all study instructions and to attend all study visits \n\n Subject is able to comprehend and willing to sign an Informed Consent Form (ICF). \n\n ", - "exclusion_criteria": ": \n\n Subject has clinically atypical and/or rapidly growing seborrheic keratosis lesions \n\n Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser-Trelat) \n\n Subject has a current systemic malignancy \n\n Subject has a history of keloid formation or hypertrophic scarring \n\n Subject has used any of the following systemic therapies within the specified period prior to Visit 1: \n\n Retinoids; 180 days \n\n Glucocorticosteroids; 28 days \n\n Anti-metabolites (e.g., methotrexate); 28 days \n\n Subject has used any of the following topical therapies within the specified period prior to Visit 1 on, or in a proximity to the target lesion, that in the investigator's opinion, interferes with the application of the study medication or the study assessments: \n\n LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy (PDT)) or other energy based therapy; 180 days \n\n Retinoids; 90 days \n\n Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluorouracil, or ingenol mebutate; 60 days \n\n Glucocorticosteroids or antibiotics; 14 days \n\n Moisturizers/emollients, sunscreens; 12 hours \n\n Subject currently has or has had any of the following within the specified period prior to Visit 1 on or in a proximity to the target lesion that, in the investigator's opinion, interferes with the application of the study medication or the study assessments: \n\n A cutaneous malignancy; 180 days \n\n Experienced a sunburn; 28 days \n\n A pre-malignancy (e.g., actinic keratosis); currently \n\n Body art (e.g., tattoos, piercing, etc.); currently \n\n Excessive tan; currently \n\n Subject has a history of sensitivity to any of the ingredients in the study medications \n\n Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations \n\n Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.", - "brief_summary": "The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101 solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle.", - "NCTID": "NCT02160626" - }, - { - "brief_title": "Study of A-101 for the Treatment of Seborrheic Keratosis", - "phase": "Phase 2", - "drugs": "['A-101']", - "drugs_list": [ - "A-101" - ], - "diseases": "['Seborrheic Keratosis']", - "diseases_list": [ - "Seborrheic Keratosis" - ], - "enrollment": "119.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject is at least 18 years of age \n\n Subject has a Fitzpatrick skin type of 1-4 \n\n Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis \n\n Subject has 1 appropriate seborrheic keratosis target lesion, as defined below (Section 5.4), on the face: \n\n Have a clinically typical appearance \n\n Be treatment na\u00efve \n\n Have a Physician's Lesion Assessment (PLA) of \u22652 (Section 6.1.2) \n\n Have a longest axis that is \u22657mm and \u226415mm (Section 5.4) \n\n Have a longest dimension perpendicular to the longest axis that is \u22657mm and \u226415mm (Section 5.4) \n\n Have a thickness that is \u22642mm \n\n Be a discrete lesion \n\n Be, when centered in the area outlined by the provided 3cm diameter circular template, the only seborrheic keratosis lesion present \n\n Not be on the eyelids \n\n Not be within 5mm of the orbital rim \n\n Not be covered with hair which, in the investigator's opinion, would interfere with the study medication application or the study evaluations (NB: the study medication may bleach hair) \n\n Not be in an intertriginous fold \n\n Not be pedunculated. \n\n If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control (Section 8) for the duration of the study \n\n Subject is non-pregnant and non-lactating \n\n Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of the target lesion or which exposes the subject to an unacceptable risk by study participation \n\n Subject is willing and able to follow all study instructions and to attend all study visits \n\n Subject is able to comprehend and willing to sign an Informed Consent Form (ICF). \n\n ", - "exclusion_criteria": ": \n\n Subject has clinically atypical and/or rapidly growing seborrheic keratosis lesions \n\n Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser-Trelat) \n\n Subject has a current systemic malignancy \n\n Subject has a history of keloid formation or hypertrophic scarring \n\n Subject has used any of the following systemic therapies within the specified period prior to Visit 1: \n\n Retinoids; 180 days \n\n Glucocortico-steroids; 28 days \n\n Anti-metabolites (e.g., methotrexate); 28 days \n\n Subject has used any of the following topical therapies within the specified period prior to Visit 1 on, or in a proximity to the target lesion, which in the investigator's opinion, interferes with the application of the study medication or the study assessments: \n\n LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy(PDT)) or other energy based therapy; 180 days \n\n Retinoids; 28 days \n\n Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluorouracil, or ingenol mebutate; 60 days \n\n Glucocortico-steroids or antibiotics; 14 days \n\n Subject currently has or has had any of the following within the specified period prior to Visit 1 on, or in a proximity to the target lesion, which in the investigator's opinion, interferes with the application of the study medication or the study assessments : \n\n A cutaneous malignancy; 180 days \n\n Experienced a sunburn; 28 days \n\n A pre-malignancy (e.g., actinic keratosis); currently \n\n Body art (e.g., tattoos, piercing, etc.); currently \n\n Excessive tan; currently \n\n Subject has a history of sensitivity to any of the ingredients in the study medications \n\n Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn, excessive hair, open wounds) which, in the investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations \n\n Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.", - "brief_summary": "The purpose of this study is to evaluate the safety and dose-response of 2 concentrations of A-101 versus a vehicle control in the treatment of seborrheic keratosis.", - "NCTID": "NCT02260180" - }, - { - "brief_title": "Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions", - "phase": "", - "drugs": "['RFID Tag (Health Beacon)']", - "drugs_list": [ - "RFID Tag (Health Beacon)" - ], - "diseases": "['Non-palpable Breast Lesions']", - "diseases_list": [ - "Non-palpable Breast Lesions" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Have had stereotactic or ultrasound-guided biopsy with marker placement \n\n Have a lesion or biopsy marker that is visible under ultrasound \n\n Have surgical target < 6 cm from the skin when lying supine \n\n Have a discreet surgical target \n\n Have a lesion in which the center/focal area is defined \n\n Be at least 18 years of age or older \n\n ", - "exclusion_criteria": ": \n\n Have a palpable lesion that does not require localization \n\n Require more than one localization needle for localization of the surgical target \n\n Have undergone previous open surgical biopsy or lumpectomy in the operative breast \n\n Have an implant in the operative breast \n\n Have a cardiac pacemaker or defibrillator device", - "brief_summary": "The goal of this investigation is to obtain clinical data to show the Health Beacons Radiofrequency Identification (RFID) Localization System is safe and performs as intended as a localization device for marking and retrieving a non-palpable surgical target from the breast.", - "NCTID": "NCT01574664" - }, - { - "brief_title": "Treatment of External Genital Warts With Cryotherapy and Sinecatechins 15% Ointment", - "phase": "", - "drugs": "['Sinecatechins 15% Ointment', 'Cryotherapy alone']", - "drugs_list": [ - "Sinecatechins 15% Ointment", - "Cryotherapy alone" - ], - "diseases": "['External Genital Warts']", - "diseases_list": [ - "External Genital Warts" - ], - "enrollment": "42.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults at least 18 years old with at least two visible EGWs. \n\n Subject must be in good general health as confirmed by the medical history. \n\n Subject must be able to read, sign, and understand the informed consent. \n\n Subject must be willing to forego any other treatments for his/her EGW lesions. \n\n Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods and to comply with all study requirements including concomitant medication and other treatment restrictions. \n\n If subject is a female of childbearing potential she must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study. \n\n ", - "exclusion_criteria": ": \n\n Subject with any evidence of herpes genitalis or any other current and/or recurrent genital or uncontrolled infection, including Human Immunodeficiency Virus, Hepatitis B or Hepatitis C. \n\n Subject with an unstable medical condition as deemed by the clinical investigator. \n\n Subject with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of EGW lesions. \n\n Subject who has previously been treated in an EGW clinical trial, had treatment of anogenital warts or had systemic intake of virostatics or immunosuppressive medication within 30 days prior to Baseline Visit. \n\n Women who are pregnant, lactating, or planning to become pregnant during the study period. \n\n Subject who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc). \n\n Subject who have active chemical dependency or alcoholism as assessed by the investigator. \n\n Subject who have known allergies to any component of the study ointment. \n\n Subject who have organ allograft, skin conditions that may interfere with study ointment, or having internal (vaginal or rectal) warts that have required treatment. \n\n Subject who has received any of the following within 90 days prior to study treatment initiation: \n\n interferon or interferon inducers \n\n cytotoxic drugs \n\n immunomodulators or immunosuppressive therapies (inhaled/ intranasal corticosteroids are permitted) \n\n oral or parenteral corticosteroids \n\n topical corticosteroids if greater than 2 gm/day \n\n any dermatologic procedures or surgeries on the study area (including any EGW treatments) \n\n Subject who have used any topical prescription medications on the study area within 30 days prior to study treatment initiation.", - "brief_summary": "External Genital Warts (EGW) are the most common sexually transmitted disease associated with more than 30 types of the Human Papillomavirus (HPV). Cryotherapy is an effective method of EGW treatment. However, multiple sessions may be required with reported clearance rates ranging between 27-88%. Sinecatechins 15% ointment is Food and Drug Administration approved for three times daily application in immunocompetent subjects 18 years and older for the treatment of EGW and perianal warts. Treatment of EGW with cryotherapy followed by sinecatechins appears to be logical. Cryotherapy has direct cytodestructive effects with immediate short-term efficacy on treated EGW, while sinecatechins provide field therapy, treating both clinical and sub-clinical lesions. For this study, the investigators used sinecatechins 15% ointment twice daily regimen and anticipated that the synergistic effect with cryotherapy will provide better efficacy that cryotherapy alone. The investigators also anticipated that the sequential therapy with be safe.", - "NCTID": "NCT02147353" - }, - { - "brief_title": "Efficacy of Cantharidin in Molluscum Contagiosum", - "phase": "", - "drugs": "[\"cantharidin's vehicle\", 'Cantharidin 0.7%']", - "drugs_list": [ - "cantharidin's vehicle", - "Cantharidin 0.7%" - ], - "diseases": "['Molluscum Contagiosum, Skin Disease']", - "diseases_list": [ - "Molluscum Contagiosum", - "Skin Disease" - ], - "enrollment": "29.0", - "inclusion_criteria": "inclusion criteria: \n\n Anyone aged 5-10 years with the clinical diagnosis of molluscum contagiosum. \n\n ", - "exclusion_criteria": ": \n\n Anyone with immunosuppression including HIV or previous organ transplantation. \n\n Anyone taking immunosuppressive medications. \n\n Anyone who has previously received treatment with cantharidin. \n\n Any female who has had her first menstrual period.", - "brief_summary": "The University of North Carolina Department of Dermatology is conducting a clinical trial to evaluate a drug called cantharidin in the treatment of molluscum contagiosum. Molluscum is a common dermatologic disorder caused by a poxvirus. Molluscum typically presents with many flesh-colored bumps on the skin. It goes away on its own, though can last several months to several years. Cantharidin is a topical medicine which is applied at the clinic visit. It is well tolerated by the majority of children.", - "NCTID": "NCT00667225" - }, - { - "brief_title": "Comparative Study of the Use of Beta Blocker and Oral Corticosteroid in the Treatment of Infantile Hemangioma", - "phase": "Phase 2", - "drugs": "['Propranolol', 'Prednisone']", - "drugs_list": [ - "Propranolol", - "Prednisone" - ], - "diseases": "['Hemangioma']", - "diseases_list": [ - "Hemangioma" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with ages up to 2 years; \n\n Clinically diagnosed hemangioma, in proliferative or involutive phase, with relative indication for clinical treatment, as itemized: \n\n lesion causing alteration of regional anatomy with no systemic or functional damage and with a diameter greater than 1 centimeter, or \n\n lesion causing aesthetic deformity, or \n\n lesion causing local repetitive complications such as ulceration, bleeding or local infection, or \n\n lesion causing partial damage of orifices, or \n\n lesion causing psychological compromise. \n\n Absence of cardiopathy (normal physical examination, anamnesis, echocardiography, electrocardiography and thoracic radiography); \n\n Informed consent signed by responsible parties \n\n ", - "exclusion_criteria": ": \n\n Hemangioma with absolute indication for treatment, presenting a risk to function or life; \n\n Patients with previous treatment for infantile hemangiomas; \n\n Cardiac disease; \n\n Pulmonary disease (asthma, bronchiolitis,bronchopulmonary dysplasias) \n\n Raynaud syndrome; \n\n Pheochromocytoma; \n\n Altered echocardiography, even if asymptomatic", - "brief_summary": "Infantile Hemangioma (IH) is infancy's most common vascular tumor of infancy and most frequent benign neoplasm.~Treatment of IHs is indicated for approximately 10 to 20% of the cases. Two groups can be defined amongst indications for treatment: patients with absolute indication for treatment and patients with relative indication for treatment.~Absolute or emergency indications comprise function or life threatening situations such as obstruction of airways, obstruction of vision, congestive heart failure, hepatic and coagulation problems.~The following are considered relative indications: cases of large and disfiguring facial hemangiomas; locations that can result in a deformity and/ or permanent scar (nose, ear, lip, glabellar area); extensive face hemangiomas, mainly when there is dermal damage (more probable to scar); local complications such as ulceration, infection and bleeding as well as small hemangiomas in exposed areas (hands and face), mainly if pedunculated due to its ease of excision2,7.~Treatment modalities vary according to the extension, location, presence of complications and the evolutional phase. A combination of various treatments is possible.~Beta blockers are being used in children for approximately 40 years, with proven clinical safety and no cases of death or cardiovascular disease resulting from its direct use. Recently it was reported the use of beta blockers (propanolol) for IH treatment, with significant reduction of tumor volume after introduction of the beta blocker, in a short period of time, with stable results after the end of treatment, which suggested evidences of the benefits of this drug in the tumor treatment The proposal of this study is to assess the use of propanolol in IH treatment, quantifying its effectiveness and safety under continuous monitoring and comparing it to the use of oral corticosteroid. The investigators propose the assessment of the betablockers' use in comparison to the use of corticosteroids in infants with IH in the proliferative or involuting phases, with indication for clinical treatment, and that are not alarming nor urgent; in other words, the current relative indications for treatment.", - "NCTID": "NCT01072045" - }, - { - "brief_title": "Tolerance and Efficacy Evaluation of 3 Face Creams", - "phase": "", - "drugs": "['Soothing (formulation number: F#1048-082) and antiaging creams (F#841-020 and F#1374-002)']", - "drugs_list": [ - "Soothing (formulation number: F#1048-082) and antiaging creams (F#841-020 and F#1374-002)" - ], - "diseases": "['Skin Aging']", - "diseases_list": [ - "Skin Aging" - ], - "enrollment": "45.0", - "inclusion_criteria": "inclusion criteria: \n\n female gender \n\n age > 35 years old \n\n good general state of health \n\n woman who had already undergone Hyaluronic acid injections \n\n woman who have not applied any retinoid product in the last 3 months \n\n woman who are not in a recovery period after laser/peeling/acne treatment \n\n accepting to return to the centre for the planned visits \n\n accepting to follow the investigator's instructions during the entire study period \n\n agreeing to present at each study visit without make-up \n\n accepting to not change their habits regarding: food, physical activity, face cleansing and make-up use \n\n agreeing to not receive any drug able to change the skin characteristics during the entire duration of the study \n\n accepting to not receive any cutaneous anti-age treatment during the entire duration of the study \n\n accepting not to expose their face to strong UV irradiation (UV session or sun bathes) during the entire duration of the study \n\n accepting to sign the Informed consent form. \n\n ", - "exclusion_criteria": ": \n\n Pregnancy (only for subjects not in menopause) \n\n lactation (only for subjects not in menopause) \n\n subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study; \n\n subjects not in menopause who do not accept to perform the pregnancy test during the basal visit (T0), 6 and 12 weeks after the intradermal implant execution; \n\n subjects participating to a similar test less than 3 months ago \n\n sensitivity to the test products or theirs ingredients \n\n subjects whose insufficient adhesion to the study protocol is foreseeable. \n\n dermatitis \n\n presence of cutaneous disease on the tested area as lesions, scars, malformations. \n\n clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.) \n\n recurrent facial/labial herpes. \n\n diabetes \n\n endocrine disease \n\n hepatic disorder \n\n renal disorder \n\n cardiac disorder \n\n pulmonary disease \n\n digestive disease \n\n haematological disease \n\n chronic phlogosis or autoimmune disease \n\n cancer \n\n neurological or psychological disease \n\n drug allergy. \n\n systemic corticosteroids \n\n retinoid products in the previous 3 months and during the entire study period \n\n aspirin or non-steroid anti-inflammatory drugs (FANS) \n\n anti-histaminic, narcotic, antidepressant, immunosuppressive drugs (with except, for female subjects, of contraceptive or hormonal treatment starting from at least one year) \n\n assumption of drugs able to influence the test results in the investigator opinion.", - "brief_summary": "The study will evaluate the tolerance and the efficacy on skin comfort of F#1048-082 soothing cream used just after injection procedure and also the tolerance and the efficacy of the F#841-020 anti-age cream on aging parameters compared to baseline and to the F#1374-002 placebo cream (comparison within subjects - half face method) to identify additional benefits delivered by the product compared to a cosmetic procedure.", - "NCTID": "NCT02063971" - }, - { - "brief_title": "Electrocautery vs Q-switch for Seborrheic Keratosis", - "phase": "", - "drugs": "['Hyfrecator', '532 nm Q-switched Nd:YAG laser']", - "drugs_list": [ - "Hyfrecator", - "532 nm Q-switched Nd:YAG laser" - ], - "diseases": "['Keratosis, Seborrheic']", - "diseases_list": [ - "Keratosis", - "Seborrheic" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects are Caucasian or Asian. \n\n Subjects who are between 18-65 year olds. \n\n Subjects have flat or macular seborrheic keratosis on dorsum of the hands and wrists, extensor surfaces of the forearms. The diagnosis of flat seborrheic keratosis is confirmed by two clinical dermatologists using routine clinical examination and dermoscopy. \n\n Subjects have Fitzpatrick skin type I-III. \n\n Subjects are in good health. \n\n Subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator. \n\n ", - "exclusion_criteria": ": \n\n History of keloids or hypertrophic scars. \n\n Pregnant or lactating or intends to become pregnant in the next 3 months. \n\n Active skin disease or skin infection in the treatment area. \n\n Previous history of lidocaine allergy. \n\n History of methemoglobinemia \n\n Unable to understand the protocol or to give informed consent. \n\n Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical study or would pose as an unacceptable risk to subject.", - "brief_summary": "The primary objective of this study is to compare the efficacy and risk of adverse events of electrocautery versus 532 nm Q-switched neodymium-doped yttrium aluminium garnet (Nd:YAG) laser for the treatment of flat seborrheic keratoses.~This study is a pilot study designed to determine feasibility of these procedures.", - "NCTID": "NCT02366559" - }, - { - "brief_title": "Feasibility Study of Cryotherapy for Chronic Venous Disorders", - "phase": "", - "drugs": "['cyrotherapy as a cool gel wrap']", - "drugs_list": [ - "cyrotherapy as a cool gel wrap" - ], - "diseases": "['Venous Insufficiency']", - "diseases_list": [ - "Venous Insufficiency" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged 45 years and older \n\n CEAP classification: stage C4 (changes in skin and subcutaneous tissue secondary to CVDs)4a (pigmentation or eczema) 4b (lipodermatosclerosis or atrophie blanche) C5 (healed venous ulcers) \n\n Ankle brachial index (ABI) 0.9 - 1.3mm Hg 0 absence of peripheral arterial disease \n\n Intact skin sensation measured with 10 gram monofilament \n\n Intact thermal sensation measured with thermal sensory tester at lower leg skin and foot surfaces \n\n Agreement to wear compression garments such as wraps or stockings during waking hours \n\n Phone, e-mail, or mail accessible \n\n Working freezer \n\n ", - "exclusion_criteria": ": \n\n ABI < 0.8 mm Hg or > 1.3 mm Hg -presence of lower extremity arterial disease (reduces skin temperature) \n\n Active systemic or localized infections such as cellulitis (raises skin temperature) \n\n Autoimmune disorders that reduce blood flow such as Raynaud's phenomenon \n\n Body temperature > 37.6 degrees C (febrile state raises skin temperature) \n\n CEAP classification c6: active venous ulcer (cooling ulcerated skin might impair healing) \n\n Known peroneal nerve injury \n\n Impaired skin sensation \n\n Unable to detect light touch measured with a 10 gram monofilament at lower leg skin surfaces \n\n Unable to detect not/cold sensation measured with thermal sensory tester at lower leg skin surfaces \n\n Not wearing compression or not agreeing to wear compression wraps or stockings \n\n Phone, e-mail, or mail inaccessible \n\n No working freezer", - "brief_summary": "Severe skin damage caused by chronic venous disorders (CVDs) results in relentless pain and poor quality of life for millions of adults in the U.S. each year. DVDs are under-recognized and under-treated disorders shat harm the veins of the legs and at worst, cause skin inflammation and venous leg ulcers. A new way to ease the pain and inflammation is proposed in this study of cryotherapy (cool gel wraps) applied to damaged skin of the lower legs of CVD-affected individuals. The study hypothesis predicts that this novel cryotherapy model and method will significantly improve the health and quality of life for those with CVDs and that the intervention will become a standard of care for CVDs. In addition, the method will, over time, reduce health care costs associated with treating poor CVD outcomes.", - "NCTID": "NCT00617825" - }, - { - "brief_title": "Prospective Evaluation of the Use of Intralesional Cryotherapy for Treatment of Keloid and Hypertrophic Scars", - "phase": "", - "drugs": "['Intralesional cryotherapy']", - "drugs_list": [ - "Intralesional cryotherapy" - ], - "diseases": "['Keloid', 'Cicatrix, Hypertrophic']", - "diseases_list": [ - "Keloid", - "Cicatrix", - "Hypertrophic" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Keloids, defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion \n\n Hypertrophic scars1 older than 12 months and insensitive to other treatments. Keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (>1yr) \n\n A period between previous treatment and IL cryotherapy covered a minimum of 12 weeks \n\n Patients with all Fitzpatrick17 skin types \n\n Patients older than 10 years of age \n\n ", - "exclusion_criteria": ": \n\n pregnancy \n\n diabetes mellitus", - "brief_summary": "This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids and hypertrophic scars in a large population of mixed Fitzpatrick skin types.", - "NCTID": "NCT01994616" - }, - { - "brief_title": "Cooling Lower Leg Skin to Prevent Venous Leg Ulcers in Patients With Poor Vein Circulation", - "phase": "Phase 1; Phase 2", - "drugs": "['Cryotherapy: Cooling gel wrap', 'Usual care']", - "drugs_list": [ - "Cryotherapy: Cooling gel wrap", - "Usual care" - ], - "diseases": "['Venous Disease', 'Venous Vascular Diseases and Syndromes', 'Venous Insufficiency', 'Venous Ulcers']", - "diseases_list": [ - "Venous Disease", - "Venous Vascular Diseases and Syndromes", - "Venous Insufficiency", - "Venous Ulcers" - ], - "enrollment": "197.0", - "inclusion_criteria": "inclusion criteria: \n\n aged 21 years or older \n\n CEAP Classification: Stage C4 (skin damage) and 5 (healed VLU) - leg ulcer healed within past month with intact epithelium \n\n history of healed VLU within past 2 years \n\n ankle brachial index (ABI) 0.80 - 1.3 mmHG, absence of peripheral arterial disease \n\n intact skin sensation \n\n intact thermal sensation \n\n agreement to ear compression during waking hours \n\n phone, email or mail accessible \n\n willingness to make 5 study visits including baseline \n\n able to understand protocol by passing test after watching DVD standardized instructions for low literacy \n\n able to perform required protocol activities \n\n ability to speak English \n\n ", - "exclusion_criteria": ": \n\n diagnosed arterial disease or ABI <0.80 or >1.3 mm Hg (blood flow to the skin is reduced in arterial disease and cooling could cause tissue ischemia) \n\n surgical procedures on leg in past 1 year (can affect venous circulation/cause edema) \n\n open leg/foot ulcers \n\n recent leg infection within past month (increased inflammation) \n\n impaired cognitive status (cannot perform procedures) \n\n chronic inflammatory and vascular conditions where blood flow of the skin may be impacted such as Lupus erythematosus, lymphedema, Raynaud's, rheumatoid arthritis, scleroderma, end stage renal disease, chronic obstructive pulmonary disease, chronic regional pain syndrome, multiple sclerosis, hypersensitivity to cold, or patients on chemotherapy", - "brief_summary": "Leg vein circulation problems can damage the skin of the lower legs, especially around the ankles, by making it discolored, hard, itchy, red, and swollen. Ulcers often develop. Inflammation is often present in the damaged skin. This study will test whether using a special low compression, cooling, boot-like gel wrap placed around the damaged skin of the lower legs will improve the skin circulation and prevent leg ulcers. The study hypothesis is: A cryotherapy, low-compression cooling gel wrap (CW) plus usual care (UC) (leg elevation, compression stockings) intervention compared to a low compression non-cryotherapy sham wrap (NW) plus UC will reduce tissue blood flow (perfusion units) and decrease the incidence of venous leg ulcers (VLUs) during the 9-month study period in individuals with Stage 4 and 5 venous insufficiency.", - "NCTID": "NCT01509599" - }, - { - "brief_title": "A Study of JNJ 10229570-AAA to Evaluate Safety and Tolerability in Japanese Participants With Acne Vulgaris", - "phase": "Phase 1", - "drugs": "['JNJ 10229570-AAA 1.2%', 'JNJ 10229570-AAA 3.6%', 'Color-matched vehicle containing 0 mg of JNJ 10229570-AAA']", - "drugs_list": [ - "JNJ 10229570-AAA 1.2%", - "JNJ 10229570-AAA 3.6%", - "Color-matched vehicle containing 0 mg of JNJ 10229570-AAA" - ], - "diseases": "['Acne Vulgaris']", - "diseases_list": [ - "Acne Vulgaris" - ], - "enrollment": "18.0", - "inclusion_criteria": "inclusion criteria: \n\n Have Acne vulgaris, presenting at least inflammatory lesion on the face \n\n Body mass index between 18.0 and 30.0 kg/m2 (inclusive), and body weight not less than 50 kg (man) or 45 kg (woman) \n\n Blood pressure between 90 and 140 mmHg systolic (inclusive), and no higher than 90 mmHg diastolic \n\n Electrocardiogram (ECG) consistent with normal cardiac conduction and function \n\n Non-smoker \n\n Adequate contraception method for both men and women. If a woman, must have a negative pregnancy test \n\n Signed an informed consent document \n\n ", - "exclusion_criteria": ": \n\n History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results \n\n Clinically significant abnormal values for hematology, biochemistry or urinalysis \n\n Clinically significant abnormal physical examination, vital signs or ECG - Use of any prescription or nonprescription medication within 14 days before the study treatment \n\n History of drug or alcohol abuse within the past 5 years \n\n Drug allergy or drug hypersensitivity \n\n Blood donation, depending on the volume of blood collection \n\n Positive test for human immunodeficiency virus (HIV), hepatitis B or C, or syphilis \n\n Dermatological disease at application site \n\n Photosensitivity \n\n Exposure to excessive or chronic ultraviolet (UV) radiation (i.e., sunbathing, tanning salon use, phototherapy) within 4 weeks prior to study treatment or planned during the study period", - "brief_summary": "The purpose of this study is to evaluate the safety and tolerability of JNJ 10229570-AAA after a single topical application of JNJ 10229570-AAA 1.2% and 3.6% cream in Japanese participants with acne.", - "NCTID": "NCT01492647" - }, - { - "brief_title": "RCT of the 4mm vs. the 8mm Collimator for GKR of Brain Micrometastases", - "phase": "", - "drugs": "['GKR with a single shot of the 8 mm collimator', 'GKR with a single shot of the 4 mm collimator']", - "drugs_list": [ - "GKR with a single shot of the 8 mm collimator", - "GKR with a single shot of the 4 mm collimator" - ], - "diseases": "['Brain Micrometastases']", - "diseases_list": [ - "Brain Micrometastases" - ], - "enrollment": "298.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult patients with brain metastasis from any primary tumour receiving GKR. \n\n All intracranial micro-metastases including lesions located in the cerebral hemispheres, thalamus, basal ganglia and cerebellum and excluding lesions located in the brain stem below the level of the superior colliculi. \n\n Target volume < 0.14 cc3 and maximum diameter < 7 mm. \n\n The subject consents to participate in the study. \n\n ", - "exclusion_criteria": ": \n\n Inability to consent \n\n Younger than 18 years of age. \n\n Lesions in the brainstem (below the level of the superior colliculi) are better treated with the 4 mm collimator and they will be excluded from the study. \n\n Patients with more than 25 brain lesions suitable for randomisation will be excluded from the study. \n\n Co-morbidity or previous treatment such as surgery, chemotherapy or WBRT is not to be considered as ", - "brief_summary": "Gamma Knife Radiosurgery (GKR) is a well-established treatment modality for brain metastasis (Chiou 2013; Salvetti, Nagaraja et al. 2013). Large multicentre series have been published on patients with single and multiple cerebral metastases, treated with GKR over a period of 30 years (Karlsson, Hanssens et al. 2009). Multiple institutions have reported a consistently high local tumour control rate of 80%-90% following GKR (Chang, Lee et al. 2000; Da Silva, Nagayama et al. 2009; Salvetti, Nagaraja et al. 2013).~There is controversy over the use of GKR and/or Whole Brain Radiotherapy (WBRT) in patients with multiple metastases. WBRT provides a lower rate of distant recurrences, whereas GKR achieves good local control of treated lesions without the deleterious side effects of radiotherapy (Lippitz, Lindquist et al. 2014). This discussion is mainly focused on the risk of distant recurrences, which is lower if WBRT is given. There is evidence showing that Radiosurgery (RS) based on high contrast/resolution stereotactic MRI decreases the incidence and lengthens the time to distant recurrences (Hanssens, Karlsson et al. 2011). As a result, the current tendency is to treat all the lesions visible in high contrast/resolution images the day of Gamma Knife; which is followed by regular MRI follow ups and subsequent GKR for distant recurrences in order to avoid/delay WBRT.~It has been estimated that more than a half of distant recurrences will grow from tumour cells that were already in the brain (as micrometastases) when radiosurgery is delivered, but not much has been studied on the optimal prescription and radiation delivery method for these lesions. There is controversy over which collimator should be used when treating micro-metastases (BmM). These lesions can either be treated with the 4mm collimator at an isodose between the 40% and 90%, or the 8mm collimator at an isodose above 90%. The 8 mm collimator is thought to offer better Local Control Rate (LCR) with the advantage of faster delivered treatments, while the 4 mm collimator is considered to be safer, given its steep dose fall-off. It is the aim of this study to find out which of the 4 mm or 8 mm collimators can achieve the higher LCR with less complications. A large number of lesions will be randomised to either the 4 or the 8 mm collimator and the patients followed up to evaluate clinical efficacy.", - "NCTID": "NCT02220127" - }, - { - "brief_title": "Spectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia", - "phase": "", - "drugs": "['Metformin', 'Dietary Modification']", - "drugs_list": [ - "Metformin", - "Dietary Modification" - ], - "diseases": "['Acanthosis Nigricans', 'Hyperinsulinemia', 'Spectroscopic Analysis']", - "diseases_list": [ - "Acanthosis Nigricans", - "Hyperinsulinemia", - "Spectroscopic Analysis" - ], - "enrollment": "9.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects must have an elevated fasting insulin level, suggesting they are in an insulin resistant state. \n\n Subjects must carry a diagnosis of acanthosis nigricans, which will be verified by a Dermatologist before entry into the study. If necessary, a small 4mm punch biopsy may be taken to document dermatopathology consistent with acanthosis nigricans. \n\n Subjects must be willing and able to undergo treatment with Metformin, including initial referral and follow up. \n\n Agree to abide by the investigator's guidelines \n\n Be able to understand the requirements of the study, the risks involved and are able to sign the informed consent form \n\n Agree to follow and undergo all study-related procedures \n\n ", - "exclusion_criteria": ": \n\n Subjects with Type 1 Diabetes are excluded because of their naturally insulin-deficient, rather than hyper-insulinemic, states. \n\n Women who are lactating, pregnant, or planning to become pregnant. \n\n Any reason the investigator feels the patient should not participate in the study. \n\n -", - "brief_summary": "Acanthosis Nigricans is skin disease that associated with hyperinsulinemia. Clinical is velvety hyperpigmented plaques on neck, axilla, groin. If hyperinsulinemia is improved by treated with oral metformin and/ or diet control, acanthosis nigricans would be improved as well. Hyperpigmented plaques will be changed. We assess objective measurement by using spectroscopic and colorimetric analysis.", - "NCTID": "NCT01125150" - }, - { - "brief_title": "Experience and Enhancement: Improving Colonoscopic Polyp Detection", - "phase": "", - "drugs": "['colonoscopy']", - "drugs_list": [ - "colonoscopy" - ], - "diseases": "['Polyps']", - "diseases_list": [ - "Polyps" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients: over 18 years of age, with clinical indication for colonoscopy who are considered by the endoscopist to be fit for the procedure \n\n Endoscopists who have started colonoscopy training on a recognised training rotation. Consultants who perform colonoscopy regularly \n\n ", - "exclusion_criteria": ": \n\n patients under 18 years, patients with previous colorectal surgery or known familial polyposis, patients unable to give informed consent, pregnant patients, patients for whom coloscope insertion was difficult or uncomfortable, patients whose colon is not sufficiently cleared of stool, those unwilling to participate", - "brief_summary": "The study looks at 2 hypotheses in 2 patient groups:~Are more experienced endoscopists better at detecting subtle lesions (polyps) on the lining of the colon (large bowel) than less experienced endoscopists?~Do existing and new techniques that can highlight lesions on the lining of the bowel improve endoscopists ability to spot them? This will be tested using video footage of endoscopies from 2 patient groups: those with a normal colon linig and those with colitis (bowel lining inflamation)", - "NCTID": "NCT00237276" - }, - { - "brief_title": "Intralesional Cryosurgery for Basal Cell Carcinoma - a Feasibility Study", - "phase": "", - "drugs": "['Intralesional cryotherapy']", - "drugs_list": [ - "Intralesional cryotherapy" - ], - "diseases": "['Basal Cell Carcinoma (BCC)']", - "diseases_list": [ - "Basal Cell Carcinoma (BCC)" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients over 60 years old \n\n BCC was determined with tissue diagnosis in the lower extremity \n\n One or more risk factor for surgical complication including: diabetes, venous insufficiency, obesity, peripheral vascular disease, lymphedema and long term steroids use. \n\n ", - "exclusion_criteria": ": \n\n Patient unable to read, understand and sign the consent form", - "brief_summary": "A feasibility study for the treatment of Basal Cell Carcinoma of the lower extremities in the elderly utilizing intralesional cryosurgery.~10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion (BCC) and thus the BCC is frozen. Treatment success will be determined according to biopsy results 3 months after treatment", - "NCTID": "NCT01633515" - }, - { - "brief_title": "Intralesional Cryotherapy With a Argon Gas Based Device for the Treatment of Keloid and Hypertrophic Scars", - "phase": "", - "drugs": "['Intralesional cryotherapy']", - "drugs_list": [ - "Intralesional cryotherapy" - ], - "diseases": "['Keloid', 'Cicatrix', 'Hypertrophic']", - "diseases_list": [ - "Keloid", - "Cicatrix", - "Hypertrophic" - ], - "enrollment": "33.0", - "inclusion_criteria": "inclusion criteria: \n\n Keloids, defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion \n\n Hypertrophic scars1 older than 12 months and insensitive to other treatments. Keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (>1yr) \n\n A period between previous treatment and IL cryotherapy covered a minimum of 12 weeks \n\n Patients with all Fitzpatrick17 skin types \n\n Patients older than 10 years of age \n\n ", - "exclusion_criteria": ": \n\n pregnancy \n\n diabetes mellitus", - "brief_summary": "This prospective evaluation studies the effectiveness of Intralesional (IL) cryotherapy with a argon gas based device in treating keloids and hypertrophic scars in population consisting of all Fitzpatrick skin type patients", - "NCTID": "NCT02063243" - }, - { - "brief_title": "Cryotherapy Intervention for Docetaxel-induced Nail Toxicities", - "phase": "Phase 2; Phase 3", - "drugs": "['Frozen gel glove (Elasto-Gel Mitten)']", - "drugs_list": [ - "Frozen gel glove (Elasto-Gel Mitten)" - ], - "diseases": "['Effects of Chemotherapy']", - "diseases_list": [ - "Effects of Chemotherapy" - ], - "enrollment": "65.0", - "inclusion_criteria": "inclusion criteria: \n\n patients receiving docetaxel as mono- or combination therapy \n\n patients with no nail disorders at the start of treatment \n\n life expectancy of at least 3 months \n\n ", - "exclusion_criteria": ": \n\n patients previously treated with taxane chemotherapy \n\n Raynaud's phenomenon \n\n distal metastases \n\n ungual pathology \n\n arteriopathy \n\n cold intolerance \n\n peripheral neuropathy of grade 2 or higher \n\n patients currently enrolled in clinical trials", - "brief_summary": "Between 30% and 88% of chemotherapy patients receiving docetaxel experience side effects of the hand ranging from skin and nail disfigurement, blistering, desquamation, pain, infection, and impaired treatment-related quality of life and function. Preliminary data indicate that nurse-initiated cryotherapy during treatment may lower the incidence and severity of these side effects, but several issues should be addressed before this intervention is implemented in hospital settings. These include more rigorous study design, larger sampling frames, and consideration of infection control concerns. This study will address these issues, thereby rigorously evaluating the safety and efficacy of nurse-initiated cryotherapy at Princess Alexandra Hospital.", - "NCTID": "NCT00911352" - }, - { - "brief_title": "Capecitabine and 131I-huA33 in Patients With Metastatic Colorectal Cancer", - "phase": "Phase 1", - "drugs": "['Capecitabine', '131I-huA33 (131-Iodine on humanised monoclonal antibody A33)']", - "drugs_list": [ - "Capecitabine", - "131I-huA33 (131-Iodine on humanised monoclonal antibody A33)" - ], - "diseases": "['Colorectal Neoplasms']", - "diseases_list": [ - "Colorectal Neoplasms" - ], - "enrollment": "19.0", - "inclusion_criteria": "inclusion criteria: \n\n Metastatic colorectal cancer. \n\n Histologically or cytologically proven colorectal cancer. \n\n Measurable disease on CT scan with at least one lesion >/= 2cm diameter (to allow adequate infusion imaging). \n\n Expected survival of at least 4 months. \n\n ECOG performance status 0-2. \n\n Vital laboratory parameters should be within normal range including: \n\n Neutrophils >/= 1.5 x 10^9/L; \n\n Platelets >/= 150 x 10^9/L; \n\n Serum bilirubin 50 ml/min. \n\n Age >/= 18 years. \n\n Able and willing to give valid written informed consent. \n\n ", - "exclusion_criteria": ": \n\n Previous treatment with capecitabine. \n\n Untreated active metastatic disease to the central nervous system (new or enlarging lesions on CT or MRI), or within 3 months of treatment (ie surgery or radiotherapy) for brain metastases. \n\n Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders. \n\n Liver involvement with metastatic disease > 50% liver volume. \n\n Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas). \n\n Previous external beam irradiation except if: (i) it was for standard adjuvant pelvic radiation for rectal cancer; (ii) it was for localised irradiation for skin cancer; or (iii) the sum total of all previous external beam irradiation port areas is not greater than 25% of the total red marrow. \n\n Previous treatment with a monoclonal antibody or antibody fragment AND a positive huA33 human anti-human antibody (HAHA) titre. \n\n Concomitant treatment with systemic corticosteroids. Topical or inhalational corticosteroids are permitted. \n\n Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study. \n\n Lack of availability of the patient for clinical and laboratory follow-up assessment. \n\n Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment. \n\n Pregnancy or breastfeeding. \n\n Women of childbearing potential: Refusal or inability to use effective means of contraception.", - "brief_summary": "The purpose of this clinical trial is to determine whether it is safe to treat patients with advanced colorectal cancer, with humanised A33 antibody tagged with radioactive iodine (131I-huA33) in combination with chemotherapy (capecitabine).", - "NCTID": "NCT00291486" - }, - { - "brief_title": "Ultrasound-Guided Needle Biopsy in the Diagnosis of Malignant Cervical Lymphadenopathies", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Lymphadenopathy', 'Malignancy']", - "diseases_list": [ - "Lymphadenopathy", - "Malignancy" - ], - "enrollment": "116.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with malignant cervical lymphadenopathie With US-FNA or US-CNB evaluation before \n\n ", - "exclusion_criteria": ": \n\n No ultrasound exam", - "brief_summary": "The objective of the present study was to compare ultrasound (US) characteristics and ultrasound-guided core-needle biopsy (US-CNB) with US-guided fine-needle aspiration (US-FNA) in the assessment of different malignant cervical lymphadenopathies. Patients with malignant cervical lymphadenopathie with either US-FNA or US-CNB over a 3-year period from 2007 July to 2010 Dec were retrospectively reviewed. There are two major study groups according to the treatment status of the patient's population, including patients who had pathology proofed previous cancer and with clinically cervical lymphadenopathies after treatment. The second group included patients with cervical lymphaenopathies but without previous diagnosis of malignancy and treatment. The results of cytology, or pathology and time of needle biopsy to final diagnosis were traced and recorded. Morphologic US parameters and vascular features were thoroughly evaluated and compared in different disease.", - "NCTID": "NCT01384357" - }, - { - "brief_title": "A Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris", - "phase": "Phase 2", - "drugs": "['IDP-120 Gel', 'IDP-120 Component A', 'IDP-120 Component B', 'IDP-120 Vehicle Gel']", - "drugs_list": [ - "IDP-120 Gel", - "IDP-120 Component A", - "IDP-120 Component B", - "IDP-120 Vehicle Gel" - ], - "diseases": "['Acne Vulgaris']", - "diseases_list": [ - "Acne Vulgaris" - ], - "enrollment": "350.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female at least 9 years of age and older \n\n Written and verbal informed consent must be obtained. \n\n Subject must have a score of moderate or severe on the Evaluator's Global Severity assessment at the screening and baseline visit \n\n Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening and baseline visits \n\n Subjects must be willing to comply with study instructions and return to the clinic for required visits. \n\n ", - "exclusion_criteria": ": \n\n Any dermatological conditions on the face that could interfere with clinical evaluations \n\n Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive \n\n Subjects with a facial beard or mustache that could interfere with the study assessments \n\n Subjects who are unable to communicate or cooperate with the Investigator \n\n Subjects with any underlying disease that the Investigator deems uncontrolled and poses a concern for the subject's safety while participating in the study", - "brief_summary": "The primary objective of this study is to compare the efficacy, safety, and tolerability of IDP-120 Gel to IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel in subjects with moderate to severe acne vulgaris.", - "NCTID": "NCT02537483" - }, - { - "brief_title": "Radiofrequency-Guided Localization in Patients With Abnormal Breast Tissue Undergoing Lumpectomy", - "phase": "", - "drugs": "['Lumpectomy', 'Questionnaire Administration', 'Radiofrequency-Guided Localization']", - "drugs_list": [ - "Lumpectomy", - "Questionnaire Administration", - "Radiofrequency-Guided Localization" - ], - "diseases": "['Breast Neoplasm']", - "diseases_list": [ - "Breast Neoplasm" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Have had stereotactic or ultrasound-guided biopsy with marker placement \n\n Have a lesion or biopsy marker that is visible under ultrasound \n\n Have a surgical target =< 6 cm from the skin when lying supine \n\n Have a discreet surgical target \n\n Have a lesion in which the center/focal area is defined \n\n Have the ability to understand and the willingness to sign a written informed consent document \n\n Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status will not be used as an inclusion criterion \n\n Ability to understand and the willingness to sign a written informed consent document \n\n ", - "exclusion_criteria": ": \n\n Require more than one localization needle for localization of the surgical target (bracket localization) \n\n Have undergone previous open surgical biopsy, lumpectomy, or mastectomy in the operative breast \n\n Have a prosthesis/implant in the operative breast \n\n Have a cardiac pacemaker or defibrillator device \n\n Be contraindicated for surgery \n\n Be pregnant", - "brief_summary": "This pilot clinical trial studies the use of the radiofrequency-guided localization in patients with abnormal breast tissue undergoing lumpectomy (a type of breast-sparing surgery). The radiofrequency identification localization system consists of an implantable radiofrequency identification tag and a hand-held radiofrequency reader to mark abnormal breast tissue before surgery and later surgically retrieve them. Radiofrequency-guided localization may make it easier to find and remove abnormal breast tissue during lumpectomy.", - "NCTID": "NCT02432118" - }, - { - "brief_title": "Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris", - "phase": "Phase 2", - "drugs": "['IDP-123 Lotion', 'Tazorac Cream, 0.1%,', 'Vehicle Cream', 'Vehicle Lotion']", - "drugs_list": [ - "IDP-123 Lotion", - "Tazorac Cream", - "0.1%,", - "Vehicle Cream", - "Vehicle Lotion" - ], - "diseases": "['Acne Vulgaris']", - "diseases_list": [ - "Acne Vulgaris" - ], - "enrollment": "210.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female at least 12 years of age and older \n\n Written and verbal informed consent must be obtained \n\n Subject must have a score of moderate or severe on the Evaluator's Global Severity assessment \n\n Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits \n\n Subjects must be willing to comply with study instructions and return to the clinic for required visits \n\n ", - "exclusion_criteria": ": \n\n Any dermatological conditions on the face that could interfere with clinical evaluations \n\n Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive \n\n Subjects with a facial beard or mustache that could interfere with the study assessments \n\n Subjects who are unable to communicate or cooperate with the Investigator \n\n Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subjects safety while participating in the study", - "brief_summary": "The primary objective of this study is to compare the safety and efficacy of once daily application of IDP-123 Lotion to Tazorac Cream, 0.1%, Vehicle Lotion, and Vehicle Cream in subjects with moderate to severe acne vulgaris.", - "NCTID": "NCT02525822" - }, - { - "brief_title": "The Use of Prophylactic Hemoclips in the Endoscopic Resection of Large Pedunculated Polyps", - "phase": "", - "drugs": "['Hemoclip', 'Conventional Polipectomy']", - "drugs_list": [ - "Hemoclip", - "Conventional Polipectomy" - ], - "diseases": "['Postpolypectomy Bleeding']", - "diseases_list": [ - "Postpolypectomy Bleeding" - ], - "enrollment": "108.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with one or more pedunculated polyps, the heads of which measured more than 1cm (regardless of the stalk thickness and length), and they were compared against the size of the biopsy forceps (6mm) and subsequently confirmed in the anatomical specimen \n\n Not to have any hemostatic alterations at the time the endoscopy was performed (confirmed by the usual blood tests taken before the procedure). \n\n ", - "exclusion_criteria": ": \n\n Patients younger than 18 years of age \n\n Patients with a platelet count of less than 50000, INR larger than 1.5 \n\n Patients who refused to give their informed consent.", - "brief_summary": "The aim of our study is to analyze the advantages of the prophylactic use of hemoclips before polypectomy in our usual clinical practice, through a prospective randomized study that determines their effectiveness compared to conventional polypectomy, assessing the decrease in immediate and delayed post-polypectomy bleeding", - "NCTID": "NCT01565993" - }, - { - "brief_title": "The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms", - "phase": "", - "drugs": "['Stent assisted coiling with the Liberty Stent']", - "drugs_list": [ - "Stent assisted coiling with the Liberty Stent" - ], - "diseases": "['Wide-neck, Saccular Intracranial Aneurysms']", - "diseases_list": [ - "Wide-neck", - "Saccular Intracranial Aneurysms" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n At least 18 years old \n\n A wide-neck intracranial saccular aneurysm with a neck \u2265 4mm or a dome to neck ratio <2 in the ICA from the cavernous segment to the carotid terminus (including the paraclinoid, ophthalmic, hypophyseal and posterior communicating segments) \n\n Life expectancy > 12 months \n\n Signed Informed Consent \n\n ", - "exclusion_criteria": ": \n\n Females who are pregnant or intend to become pregnant during the study. (Females of child-bearing potential must have a urinary pregnancy test within 7 days of enrollment) \n\n Extradural aneurysms \n\n Known multiple untreated cerebral aneurysms at study entry \n\n Recent history of subarachnoid hemorrhage, intracranial hemorrhage, or major surgery within one month of enrollment \n\n Admission platelet <50,000 or any known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an INR >3.0 \n\n Contraindication to angiography such as elevated creatinine or known allergy to angiographic contrast \n\n Contraindication to CT and/or MRI scans \n\n Known allergy to the metal component of the Penumbra Liberty Stent System \n\n Evidence of active infection (WBC >10x109 /L) \n\n Any medical conditions that will not allow the necessary follow-up for this study (e.g., pre-existing neurological or psychiatric diseases) \n\n Current substance-abuse /illicit drug use \n\n Angiographic evidence of an arterial stenosis proximal to the target lesion that could prevent device deployment \n\n Contraindications to study medications (heparin, aspirin, clopidogrel, and radiographic contrasts)", - "brief_summary": "To assess the safety and effectiveness of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA). The Liberty Stent System is an implantable device comprised of a stent and delivery system designed as an adjunct to embolic coils in the treatment of wide-neck, saccular, intracranial aneurysms. It has three components: an implant, an introducer sheath and a delivery wire assembly. The implant component is made of superelastic and biocompatible nitinol tubular material. Patients presenting with wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA) from the cavernous segment to the carotid terminus (including the paraclinoid, ophthalmic, hypophyseal and posterior communicating segments) will receive stent assisted coiling by the Penumbra Liberty Stent with any approved embolic coils currently on the market. Wide-neck aneurysms are defined by a neck \u22654mm or a dome-to-neck ratio <2. Each patient will be followed and assessed for 2, 6 and 12 months after enrollment.", - "NCTID": "NCT01636453" - }, - { - "brief_title": "Cold Snare Polypectomy Versus. Endoscopic Mucosal Resection", - "phase": "", - "drugs": "['EMR', 'CSP']", - "drugs_list": [ - "EMR", - "CSP" - ], - "diseases": "['Colonic Polyp']", - "diseases_list": [ - "Colonic Polyp" - ], - "enrollment": "103.0", - "inclusion_criteria": "inclusion criteria: \n\n All those over the age of 20 years who agree informed consent and who have at least one polyp of eligible size (6-10 mm) \n\n ", - "exclusion_criteria": ": \n\n (1) patients taking anticoagulant therapy during the past 1 week of the procedure, (2) known coagulopathy, (3) history of liver cirrhosis, chronic kidney disease, malignancy, inflammatory bowel diseases or significant infectious disease, (4) American Society of Anesthesiology class III or more, and (5) pedunculated polyps and polyps with malignant feature.", - "brief_summary": "The investigators will investigate the efficacy of EMR compared to CSP in treatment of small colon polp (6~10mm).~One aim of this study was to investigate the necessity of EMR on resection of small colon polyp.", - "NCTID": "NCT02476747" - }, - { - "brief_title": "Effect of Prophylactic Clip Application for the Prevention of Postpolypectomy Bleeding in Pedunculated Colonic Polyps", - "phase": "", - "drugs": "['Prophylactic clip', 'No prophylactic management']", - "drugs_list": [ - "Prophylactic clip", - "No prophylactic management" - ], - "diseases": "['Bleeding']", - "diseases_list": [ - "Bleeding" - ], - "enrollment": "238.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with pedunculated colorectal polyps, the heads of which were larger than 10mm and the stalk of which were large than 5 mm in diameter, were included. \n\n ", - "exclusion_criteria": ": \n\n bleeding tendency, poor preparation, sessile polyp", - "brief_summary": "Although endoscopic colonic polypectomy has been an established procedure for two decades, the risk of bleeding is still higher after resecting of pedunculated polyps, because of the presence of a large artery in the stalk. Preventive methods such as endoloop and epinephrine injection have been proposed in the management of postpolypectomy bleeding in large colonic polyps. For prophylactic clip, there was no randomized controlled study assessing the efficacy in the prevention of postpolypectomy bleeding for the large pedunculated polyps. So the investigators designed a randomized controlled trial to confirm the efficacy of application of prophylactic clip in the prevention of postpolypectomy bleeding in large polyps.", - "NCTID": "NCT02156193" - }, - { - "brief_title": "Evaluation of Stool Tagging for Improved Patient Compliance", - "phase": "", - "drugs": "['Imaging procedure of CT colonography']", - "drugs_list": [ - "Imaging procedure of CT colonography" - ], - "diseases": "['Colon Cancer', 'Polyps']", - "diseases_list": [ - "Colon Cancer", - "Polyps" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who are 45 to 80 years old for routine screening colonoscopy \n\n ", - "exclusion_criteria": ": \n\n Patients with inflammatory bowel disease \n\n Patients with polyposis syndromes \n\n Pregnant women \n\n Patients over 350 pounds \n\n Patients with bright red blood per rectum \n\n Patients who have a contraindication to undergo outpatient colonoscopy, including patients on blood thinners, prior myocardial infarction (MI) in the last six months, history of congestive heart failure (CHF), history of arrhythmia, patients too weak to transfer themselves from a bed to a chair, or patients with severe constipation who would require a two day bowel preparation. \n\n All subjects will undergo informed consent by the St. Luke's institutional review board (IRB). Referred subjects will be asked if they are interested in the study and those responding affirmatively will be transferred to a recruiter to learn about the study and begin the consent process if interested.", - "brief_summary": "Computed tomography (CT) colonography has gained widespread multi-disciplinary interest as an evolving noninvasive colorectal screening examination, with the potential of improved patient compliance. The investigator's prior work demonstrated that the bowel preparation was the least tolerable aspect of colorectal evaluation when compared to the CT colonography and optical colonoscopy procedures. Stool tagging could provide a more gentle and efficient bowel preparation, with fewer false positives due to retained stool-mimicking polyps.~The researchers hypothesize that image quality and patient preference will vary with stool tagging concentration and dosing schedule. The researchers propose to evaluate specific stool tagging protocols with the following aims:~AIM 1: Perform a randomized trial of three specific stool tagging protocols using barium and iodine at CT colonography in a well-characterized cohort of patients undergoing colorectal evaluation.~AIM 2: Analyze the CT colonography and optical colonoscopy data to assess differences across stool tagging protocols for the outcome measures of patient preference, image quality in the presence of tagging, and diagnostic reader performance.~The researchers will use specific variations in stool tagging techniques to determine the best image quality of CT data (e.g., homogenous tagging of fluid and stool), and highest patient acceptability, as well as evaluate the adequacy of preparation for same-day colonoscopy. Diagnostic reader performance will focus on the accuracy for detecting all neoplastic lesions including colon cancers, adenomatous polyps, sessile adenomas and flat adenomas. Most importantly, these results will help inform the design of a larger trial of an optimized CT colonography technique in a community setting.", - "NCTID": "NCT00124163" - }, - { - "brief_title": "Transanal Endoscopic Microsurgery Versus Endoscopic Submucosal Dissection For Large Rectal Adenomas", - "phase": "Phase 4", - "drugs": "['TEM - Transanal Endoscopic Microsurgery', 'ESD - Endoscopic Submucosal Dissection']", - "drugs_list": [ - "TEM - Transanal Endoscopic Microsurgery", - "ESD - Endoscopic Submucosal Dissection" - ], - "diseases": "['RECTAL NEOPLASMS']", - "diseases_list": [ - "RECTAL NEOPLASMS" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosed with a large non-pedunculated rectal adenoma (sessile or flat) with a largest diameter of \u22652 cm (estimated by an opened resection snare of 20 or 30 mm). \n\n The lower and upper borders of the adenoma are located at \u22652 cm and \u226415 cm from the anal verge, respectively. \n\n Biopsies of the lesion did not show malignant neoplastic tissue on histopathological evaluation; only lesions with low or high grade dysplasia are suitable for inclusion. \n\n During flexible video endoscopy there are no signs of endoscopic suspicion for submucosal invasive cancer (Kudo pit pattern type V; excavated/depressed type morphology; fold convergence; or large smooth nodule >1 cm in a flat lesion) (33). In case of doubt, patients will undergo EUS as described at (2). \n\n In case doubt remains after flexible video endoscopy, endoscopic ultrasonography (EUS) of the rectal adenoma should exclude invasion into the submucosal layer and exclude pathological lymphadenopathy (lymph nodes >1 cm). When pathological lymph nodes are present, fine needle aspiration will be performed to exclude lymph node metastasis (N+ disease). \n\n If not performed already, total colonoscopy will be done to detect and remove all synchronous colonic adenomas or cancers first. Cecal intubation must be confirmed by identification of the appendiceal orifice and ileocecal valve. \n\n The general health condition of the patient permits general anesthesia (ASA- classification I-III). \n\n Absence of non-correctable coagulopathy (international normalized ratio >1,5, or platelet count <90 \u00d7 109/l). \n\n Patient age of 18 years or older. \n\n ", - "exclusion_criteria": ": \n\n Preoperative histologically detected malignancy \n\n Previous anorectal surgery \n\n Contraindications to general anaesthesia", - "brief_summary": "Objective: Recent non-randomized studies suggest that extended endoscopic submucosal dissection (ESD) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM). If equally effective, ESD might be a more cost-effective approach as this strategy does not require expensive equipment, general anesthesia and hospital admission. Furthermore, ESD appears to be associated with fewer complications. In a randomized trial we will compare the cost-effectiveness and cost-utility of TEM and ESD for the resection of large rectal adenomas.~Study design: 15 centers will participate in this multicenter randomized trial comparing TEM versus ESD.~Study population: Patients with a large rectal adenoma (\u22652cm), located between 2 and 15 cm from the anal verge. Invasive cancer is excluded by histopathology and endoscopic ultrasonography. Patients must be in a health condition that permits general anesthesia.~Interventions: Patients will be randomized between~a. TEM: under general anesthesia b. ESD under sedation~a TEM tube will be inserted in the rectum. With specialized instruments the adenoma will be dissected en bloc by a full thickness excision, after which the patient will be admitted to the hospital.~an endoscope will be inserted into the rectum and the submucosa underneath the lesion will be injected with saline to lift the adenoma. With an endoscopic knife (Insulated Tip Knife, Olympus or Water Jet, Erbe) the lesion will be resected through the submucosal plane in an eb-bloc fashion, after which the patient will be observed for at least 24h in-hospital.~Primary Endpoint: incidence of recurrence at 12 months~Secondary Endpoints:~morbidity, subdivided into major (requiring surgery) and minor (requiring endoscopic or medical intervention) anorectal function. disease specific and general quality of life; number of days not spent in hospital from initial treatment until 2 years afterwards; adenoma~Sample size: Assuming a comparable baseline recurrence rate for TEM and ESD of 6% and considering an upper limit of 10% for ESD to be non-inferior (beta-error 0.2 and one-sided alpha-error 0.05), 60 patients are needed per group. These numbers provide sufficient power to reveal relevant differences in expected morbidity and in number of days not spent in hospital.~Economic evaluation: A cost-effectiveness and cost-utility analysis of ESD against TEM for large rectal adenomas from a societal perspective with respectively the costs per recurrence free patient and the cost per quality adjusted life year as primary outcome measures.", - "NCTID": "NCT01023984" - } - ], - "1": [ - { - "brief_title": "Pilot Study of Infrared Imaging of Cutaneous Melanoma", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Melanoma']", - "diseases_list": [ - "Melanoma" - ], - "enrollment": "74.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients or volunteers with or without a history of melanoma. \n\n One or more palpable skin or subcutaneous lesions for which at least one of the following is true: \n\n A tissue diagnosis has been made for the lesion(s) in question, by prior cytologic or histologic evaluation (Category A1). \n\n A tissue diagnosis will be obtained for the lesion(s) in question by cytologic or histologic evaluation (Category A2). \n\n A tissue diagnosis is not available, but a clinical diagnosis of melanoma or benign lesion is available with a high degree of confidence. Examples are hemangiomas, skin tags, seborrheic keratoses, dermatofibromas, lipomas, or growing pigmented skin lesions that are comparable to other cutaneous metastases of melanoma in the same patient (Category B). \n\n All patients must have the ability and willingness to give informed consent and must be age 18 years or older at the time of study entry. \n\n ", - "exclusion_criteria": ": \n\n Known or suspected allergy to the adhesive skin markers or water-soluble ink used for the labeling of lesions. \n\n Very fragile skin that may be susceptible to injury from adhesive markers. \n\n Patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator.", - "brief_summary": "Design: this is a pilot study of infrared imaging of cutaneous lesions in patients and volunteers with and without clinically detectable melanoma, and with one or more palpable cutaneous lesions eligible for this imaging study. Participants will be evaluated with infrared camera imaging at cutaneous sites with known melanoma deposits, suspected melanoma deposits that are to be biopsied, or at cutaneous sites with other lesions, including other skin cancers, benign inflammatory lesions, benign neoplastic lesions (lipomas, epidermal cysts, dermatofibromas, scar, healing wound, etc.).", - "NCTID": "NCT00937690" - }, - { - "brief_title": "MelaFind Evaluations for Patients With Multiple Nevi", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Clinically Atypical Pigmented Skin Lesion']", - "diseases_list": [ - "Clinically Atypical Pigmented Skin Lesion" - ], - "enrollment": "19.0", - "inclusion_criteria": "Cutaneous lesions examined with MelaFind must satisfy all of the following inclusion criteria: \n\n inclusion criteria: \n\n The lesion is pigmented (i.e., melanin, keratin, blood) \n\n The diameter of the pigmented area is not < 2 mm, and not > 22 mm \n\n The lesion is accessible to the MelaFind \n\n The patient, or a legally authorized representative, has consented to participate in the study and has signed the Informed Consent Form; \n\n Cutaneous lesions that meet any of the following ", - "exclusion_criteria": " will not be accepted: \n\n ", - "brief_summary": "We have added objectives 4-6 to our updated study:~Study Objective 1: To determine whether the distribution of MelaFind scores is different for different patients with multiple nevi, and whether such distributions can be utilized to identify signature lesions for a given patient.~Study Objective 2: To investigate whether distributions of quantitative ABCD parameters differ among patients and whether these qABCD parameters identify signature lesions.~Study Objective 3: To determine the feasibility of defining and using relative thresholds to improve the specificity of MelaFind without sacrificing its high sensitivity.~Study Objective 4: To determine the repeatability of MelaFind scores for a given lesion for different patient and lesion characteristics.~Study Objective 5: To identify patient and lesion characteristics that result in the highest variability of MelaFind scores for a given lesion.~Study Objective 6: To use standard errors of MelaFind scores to propose a robust individual threshold for lesions to be considered for biopsy to rule out melanoma on patients with multiple nevi.", - "NCTID": "NCT01700101" - }, - { - "brief_title": "Moletest Clinical Study in Scotland", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Melanoma']", - "diseases_list": [ - "Melanoma" - ], - "enrollment": "1120.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients referred to the Dermatology Department, Lanarkshire Hospitals during a period to be defined for assessment of suspicious skin lesions (cutaneous moles) will be eligible for inclusion in the study. There are no age limits but patients under the age of 18 years will also have their inclusion subject to parental/guardian consent \n\n ", - "exclusion_criteria": ": \n\n There is no exclsion criteria", - "brief_summary": "To evaluate an iPad based photoimage analysis system (Moletest) for improving discrimination of benign from malignant suspicious skin lesions or moles. Specifically the objective is to demonstrate that the Moletest system is able with a sufficient degree of confidence (95%) to identify lesions which are benign", - "NCTID": "NCT02196246" - }, - { - "brief_title": "Confocal Microscopy of Benign and Malignant Skin Tumors", - "phase": "", - "drugs": "['confocal microscopy']", - "drugs_list": [ - "confocal microscopy" - ], - "diseases": "['Skin Cancer']", - "diseases_list": [ - "Skin Cancer" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Men and women over the age of 18 \n\n Skin lesion suspected to either BCC or SCC etc \n\n Patient was referred for biopsy diagnostic/therapeutic before hand, and regardless of confocal microscope examination, according to the clinical consideration of physician \n\n ", - "exclusion_criteria": ": \n\n Pregnant women \n\n Children", - "brief_summary": "The investigators speculate that this tool may be used as an alternative and convenient non-invasive diagnostic of skin cancer.", - "NCTID": "NCT01010321" - }, - { - "brief_title": "Temperature Skin Check After Cryotherapy Application", - "phase": "Phase 3", - "drugs": "['cryotherapy application']", - "drugs_list": [ - "cryotherapy application" - ], - "diseases": "['Body Temperature Changes']", - "diseases_list": [ - "Body Temperature Changes" - ], - "enrollment": "24.0", - "inclusion_criteria": "inclusion criteria: \n\n belong to ethnic groups requested \n\n ", - "exclusion_criteria": ": \n\n suffering any change in skin sensitivity, illness of an infectious nature or previously diagnosed diseases that respond negatively to the use of cold", - "brief_summary": "The aim of this study was to reheat the skin in different ethnic groups after application of cryotherapy.", - "NCTID": "NCT01950026" - }, - { - "brief_title": "A Single-Center, Exploratory Study to Analyze the Dynamics of Skin Microflora Following Exposure to Surfactants", - "phase": "", - "drugs": "['PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5%', 'Lauryl glucoside (Plantacare\u00ae 1200UP, BASF) 1.5%', 'Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5%', 'Silwet* DA-63 (Momentive) 1.5%', 'Sodium lauryl sulfate (Sigma Aldrich) 1.0%', 'Water (control)']", - "drugs_list": [ - "PEG-40 Hydrogenated Castor Oil (Tagat CH40", - "Evonik) 1.5%", - "Lauryl glucoside (Plantacare\u00ae 1200UP", - "BASF) 1.5%", - "Sorbitan palmitate (SPANTM 40 (powder)", - "Croda) 1.5%", - "Silwet* DA-63 (Momentive) 1.5%", - "Sodium lauryl sulfate (Sigma Aldrich) 1.0%", - "Water (control)" - ], - "diseases": "['Dermatitis']", - "diseases_list": [ - "Dermatitis" - ], - "enrollment": "24.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy Subjects with Fitzpatrick Skin Types I, II or III \n\n ", - "exclusion_criteria": ": \n\n Subjects with visible skin disease, tattoos, skin condition, or abnormal skin color", - "brief_summary": "The purpose of this study is to understand the changes in skin microflora, skin barrier function, and skin biochemical constituents in response to direct contact with model surfactants used in personal care articles. The results from this study will provide insights into the complex interaction between the skin microbiome and the epidermis after exposure to surfactants.", - "NCTID": "NCT02615912" - }, - { - "brief_title": "A Sequential Treatment Regimen of Cryotherapy and Picato\u00ae for the Treatment of Actinic Keratosis on the Face and Scalp", - "phase": "Phase 3", - "drugs": "['Cryotherapy', 'Vehicle', 'Ingenol metabute']", - "drugs_list": [ - "Cryotherapy", - "Vehicle", - "Ingenol metabute" - ], - "diseases": "['Actinic Keratosis']", - "diseases_list": [ - "Actinic Keratosis" - ], - "enrollment": "367.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects must be competent to understand the nature of the trial and provide informed consent. \n\n Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on the face or scalp. \n\n Subject at least 18 years of age. \n\n Female subjects must be of either: \n\n Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or, \n\n Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to study treatment, to rule out pregnancy. \n\n Female subjects of childbearing potential must be willing to use effective contraception. \n\n ", - "exclusion_criteria": ": \n\n Location of the selected treatment area: \n\n on any location other than the face or scalp \n\n within 5 cm of an incompletely healed wound \n\n within 10 cm of a suspected basal cell carcinoma (BCC) or SCC \n\n Prior treatment with PEP005 Gel on face or scalp. \n\n Selected treatment area lesions that have: \n\n atypical clinical appearance and/or \n\n recalcitrant disease \n\n History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication \n\n Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety and efficacy. \n\n Any abnormal vital signs measurements that are medically significant or would impact the safety of the subject or the interpretation of the trial results. \n\n Anticipated need for hospitalization or out-patient surgery during the first 15 days after the first trial medication application. \n\n Known sensitivity or allergy to any of the ingredients in PEP005 Gel \n\n Recent excessive exposure to ultraviolet light \n\n Current enrolment or participation in a clinical trial within 30 days of entry into this study \n\n Subjects previously randomised in the trial \n\n Female subjects who are breastfeeding \n\n Prohibited Therapies and/or Medications within 2 weeks prior to Visit 1 \n\n Cosmetic or therapeutic procedures within 2 cm of the selected treatment area \n\n Use of acid-containing therapeutic products within 2 cm of the selected treatment area \n\n Use of topical medicated creams, ointments, lotions, gels, foams or sprays \n\n Prohibited Therapies and/or Medications: within 4 weeks prior to visit 1: \n\n Treatment with immunomodulators, cytotoxic drugs or inter-feron /interferon inducers \n\n Treatment with systemic medications that suppress the immune system \n\n Treatment/therapy with ultraviolet light A (UVA) or ultraviolet light B (UVB). \n\n Prohibited Therapies and/or Medications within 8 weeks prior to visit 1: \n\n Treatment with 5-FU, imiquimod, diclofenac sodium, or photodynamic therapy: within 2 cm of the selected treatment area. \n\n Prohibited Therapies and/or Medications within 6 months prior to visit 1 \n\n Use of systemic retinoids or biologic / mono-clonal antibody therapies", - "brief_summary": "The purpose of this trial is to compare the rate of complete clearance of actinic keratosis (AK) using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.", - "NCTID": "NCT01541553" - } - ], - "2": [ - { - "brief_title": "A Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Basal Cell Carcinoma']", - "diseases_list": [ - "Basal Cell Carcinoma" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Study subjects must have had diagnosed at least one benign or malignant skin lesion; \n\n Subject is from 18-75 years of age, inclusive; \n\n Subject must sign and date all informed consent statements. \n\n ", - "exclusion_criteria": ": \n\n Subject is exhibiting signs of a bacterial or viral infection, including fever; \n\n Subject is unwilling to allow a biopsy of a malignant lesion for histological analysis.", - "brief_summary": "The Dermacorder measures the electric field in the skin. Malignant skin lesions disrupt the skin's normal electric field and this abnormal electric field can be detected by the Dermacorder. Therefore the investigators are testing the hypothesis that the Dermacorder can provide useful data to guide in the diagnosis of skin disease.", - "NCTID": "NCT01014819" - }, - { - "brief_title": "A Study of Ultrasonography With Elastography in Skin Neoplasms", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Benign and Malignant Skin Neoplasms']", - "diseases_list": [ - "Benign and Malignant Skin Neoplasms" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with skin lesions undergoing biopsy for diagnosis. \n\n ", - "exclusion_criteria": ": \n\n Patients with skin lesions which do not require biopsy for diagnosis.", - "brief_summary": "This study will look at high frequency ultrasound as a medical imaging modality and apply it to skin lesions. Elastography is an ultrasonic method of looking at the hardness of an area. We will use this to try and differentiate between benign and cancerous skin lesions.", - "NCTID": "NCT01259037" - }, - { - "brief_title": "Spectral Diagnosis of Cutaneous Malignancy", - "phase": "", - "drugs": "['Spectral Diagnosis Probe']", - "drugs_list": [ - "Spectral Diagnosis Probe" - ], - "diseases": "['Skin Cancer']", - "diseases_list": [ - "Skin Cancer" - ], - "enrollment": "350.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or Female and over 18 years of age. \n\n Patients undergoing an examination of their skin \n\n Patients with a lesion(s) in one of the five categories: basal cell carcinoma, squamous cell carcinoma, pre-cancer lesions, pigmented lesions, and benign lesions \n\n Patients whose lesion also warrants a biopsy. \n\n Signed informed consent document. \n\n ", - "exclusion_criteria": ": \n\n Patients with absence of skin lesion(s) in one of the five categories. \n\n Patients whose identified lesion did not need a biopsy. \n\n Patients who did not sign the informed consent and agree to participate.", - "brief_summary": "The goal of this clinical research study is to evaluate the use of an imaging technology called spectral diagnosis. Researchers want to find out if a special spectral-diagnosis probe can be used to detect skin cancers.", - "NCTID": "NCT00476905" - }, - { - "brief_title": "In-vivo Optical Coherence Tomography Imaging in Dermatooncology", - "phase": "", - "drugs": "['in-vivo skin tumor imaging via optical coherence tomography']", - "drugs_list": [ - "in-vivo skin tumor imaging via optical coherence tomography" - ], - "diseases": "['Non-melanocytic Skin Tumors', 'Melanocytic Skin Tumors']", - "diseases_list": [ - "Non-melanocytic Skin Tumors", - "Melanocytic Skin Tumors" - ], - "enrollment": "37.0", - "inclusion_criteria": "inclusion criteria: \n\n seborrhoeic warts \n\n nevi \n\n dermatofibroma \n\n basal cell carcinoma \n\n actinic keratosis \n\n squamous cell carcinoma \n\n Bowen's disease \n\n Merkel cell carcinoma \n\n malignant melanoma \n\n ", - "exclusion_criteria": ": \n\n employers of the Medical University of Vienna \n\n patients during compulsory military service \n\n patients with an appointed guardian", - "brief_summary": "In vivo differentiation of benign and malignant skin lesions is a fundamental issue in clinical dermatology. Malignant skin diseases are known to be accompanied by structural alterations. Conventional excisional biopsies and further histopathology are regarded as the reference standard for investigating these pathologies. Biopsies are invasive procedures and additionally may cause side effects. Therefore, research efforts are focused on the development of diagnostic techniques capable of providing in vivo information on the skin's structure. Optical coherence tomography (OCT) is a technical application, which allows the identification of microscopic patterns indicative for benign and malignant skin lesions. OCT is a promising noninvasive imaging technique for the micromorphology of the skin. So far, it's clinical application, as an additional diagnostic tool for malignant skin lesions has been studied in a limited extend. To evaluate the clinical usefulness of OCT, we conducted a prospective pilot study at the Department of Dermatology, Medical University of Vienna. The study is in cooperation with the Center of Biomedical Engineering and Physics at the Medical University of Vienna.~A total of 70 malignant skin lesions was evaluated during this prospective pilot study. Diagnoses based on OCT imaging as an additional diagnostic tool, were compared to those based on the clinical standard pathway at the Department of Dermatology, Medical University of Vienna. For the purpose of this study, the histopathological diagnosis was used as the reference diagnostic standard.~The major aims of this study is the investigation of the ability of ultrahigh resolution OCT to identify fine morphological characteristics associated with basal cell carcinoma, actinic keratosis, superficial squamous cell carcinoma, seborrheic keratosis, melanocytic nevi and melanoma.~To correlate the morphologic features identified with ultrahigh resolution OCT with routine histopathology~To investigate the clinical feasibility of ultrahigh resolution and spectroscopic OCT technology~To assess the effectiveness of ultrahigh resolution and spectroscopic OCT imaging to diagnose various melanocytic and non-melanocytic skin tumors~To compare the diagnostic capabilities of ultrahigh resolution OCT with standard non-invasive diagnostic procedures such as epiluminescence microscopy", - "NCTID": "NCT01680562" - }, - { - "brief_title": "Development and Validation of a Quality of Life Instrument for Actinic Keratosis", - "phase": "", - "drugs": "['AKRQ questionnaire', 'Skindex-16, DLQI, Skin Health Calculator']", - "drugs_list": [ - "AKRQ questionnaire", - "Skindex-16", - "DLQI", - "Skin Health Calculator" - ], - "diseases": "['Actinic Keratosis']", - "diseases_list": [ - "Actinic Keratosis" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female, age 18 years or older being seen in a dermatology clinic \n\n Informed consent of participation must be given by subject \n\n ", - "exclusion_criteria": ": \n\n Inability to complete all study questionnaires. \n\n Subjects who are unable to read and write English", - "brief_summary": "Actinic keratoses (AKs) are some of the most common lesions seen by dermatologists. Flesh colored to erythematous, these lesions often present with scaling or crusting in sun damaged regions of the body. While they are physically visible and often palpable, these changes can also result in psychosocial changes in patients, including embarrassment about their skin or reduction in leisure activities to avoid further sun exposure. At the same time, AKs are known to progress in a significant number of cases to squamous cell carcinoma (SCC), a concern in terms of its metastatic potential.~The primary purpose of developing this questionnaire is to examine how well it can potentially identify patients with actinic keratoses. However, since AK is associated with significant detriment to quality of life for validity/reliability assessment, the investigators propose to give a compilation of four self-assessment questionnaires (not specific to AK but validated for skin health in general) to subjects with at least one actinic keratosis and age- and sex- matched participants without AKs, defined as the control population. These will include the SKINDEX-16, the DLQI and the Skin Health Calculator, as well as a questionnaire composed of items specific to predisposition to AKs to be able to better assess the discriminatory power of the questionnaire.", - "NCTID": "NCT01444989" - }, - { - "brief_title": "Healthy Volunteer Visibility Study of Micromachined Tags for the Detection of Surgical Sponges", - "phase": "Phase 1", - "drugs": "['Abdominal radiographs with microfabricated tags']", - "drugs_list": [ - "Abdominal radiographs with microfabricated tags" - ], - "diseases": "['Injury Due to Foreign Object Accidentally Left in Body During Surgical Operation']", - "diseases_list": [ - "Injury Due to Foreign Object Accidentally Left in Body During Surgical Operation" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy men and women \n\n Ages 18 or older - \n\n ", - "exclusion_criteria": ": \n\n Under 18 years of age \n\n Pregnant female or if female has not had a negative pregnancy test prior to the research scans. \n\n -", - "brief_summary": "Surgical sponges can be accidentally left inside patient's bodies. We are working on special tags (called microfabricated tags) that surgeons can put on their sponges. Then, if the surgeons forget to remove a sponge from a patient, they'll be able to detect these special tags in an x-ray.", - "NCTID": "NCT02009566" - } - ] - }, - { - "patient_id": "sigir-201410", - "patient": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", - "0": [ - { - "brief_title": "Randomized Comparison of MynxGrip Vascular Closure Device and Manual Compression for Closure After Femoral Access Angiography. The Closure Devices Used in Every Day Practice Study, CLOSE-UP III Trial", - "phase": "", - "drugs": "['MynxGrip', 'Manual compression']", - "drugs_list": [ - "MynxGrip", - "Manual compression" - ], - "diseases": "['Coronary Disease']", - "diseases_list": [ - "Coronary Disease" - ], - "enrollment": "869.0", - "inclusion_criteria": "inclusion criteria: \n\n >18 year \n\n Should be able to provide valid informed signed consent \n\n CAG, possibly including intracoronary measurement (FFR) or intracoronary imaging (IVUS, optical coherence tomography (OCT), NIRS) \n\n ", - "exclusion_criteria": ": \n\n Percutaneous coronary intervention (PCI) procedure and/or implantation of stents \n\n ST-Elevations Myocardial Infarction (STEMI) \n\n Multiple punctures \n\n Active infection \n\n Groin haematoma before the closure procedure \n\n Known pseudoaneurysm or arteriovenous (AV) fistula in the ipsilateral groin \n\n Cardiogenic shock \n\n Prior peripheral arterial surgery in abdomen or lower extremities \n\n Sheat size >7 F \n\n Life expectancy less than one year \n\n Possible pregnancy or positive pregnancy test or breastfeeding women \n\n Simultaneous or planned subsequent femoral vein access \n\n Allergy to any of the components in the closure material left in the groin \n\n Puncture or closure with closure device at same site < 30 days \n\n Puncture or closure with manuel compression at same site < 5 days \n\n Patients with peripheral artery disease can be included at operators discretion except if heavy calcification is present at the access site, which at the operators discretion precludes insertion of the closure device", - "brief_summary": "Is the MynxGrip (test device) non-inferior to manuel compression (standard comparator) in the incidence of adverse access site related events in-hospital, at 30 days and at 6 months.", - "NCTID": "NCT02237430" - }, - { - "brief_title": "Left vs. Right Radial Approach for Routine Catheterization of Heart Transplant Patients", - "phase": "", - "drugs": "['devices used in the coronary angiography']", - "drugs_list": [ - "devices used in the coronary angiography" - ], - "diseases": "['Cardiovascular Disease']", - "diseases_list": [ - "Cardiovascular Disease" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: eligible transplanted patients scheduled for a routine coronary angiography with age >18 years old. \n\n ", - "exclusion_criteria": ": \n\n chronic renal insufficiency (creatinine >2.0 mg/dl) with the potential necessity of using the radial artery as a native fistula will be considered one of the ", - "brief_summary": "Orthotopic heart transplantation is a well established therapeutic measure for end stage heart failure, leading to significant improvements in survival and quality of life. In the routine clinical practice, orthotopic heart transplantation patients receive periodic cardiac catheterization for early detection of allograft vascular disease.~The coronary angiography of these patients is characterized for several technical difficulties, generally related to the presence of the aortotomy with anomalous implantation of the coronary ostia and to the orthotopic position of the allograft. For these reasons, trans femoral approach is usually preferred. In the last two decades, trans radial approach for coronary angiography emerged to be effective, safe and able to improve patient comfort. However, there is no universal consensus on the optimal choice of radial access from either the left or the right artery. Currently, this choice is largely dependent on the operator's preference. The trans right radial approach is generally preferred in routine clinical practice mainly due to its easier catheter manipulation for the operators from patient's right side, and the current design of radial compression devices for the right wrist in medical market. As such, a major barrier to prevent the wide adoption of the left radial access lies in some difficulty to reach the left wrist leaning over the patient, particularly for shorter operators or in obese patients. However, a great deal of attention has been recently directed toward the trans left radial access, as it has an important anatomical advantage due to the vascular anatomy of epiaortic vessels with a straighter route to the left coronary ostium, which could also reduce the risk of cerebrovascular complications.~However, no data are available about the performance of trans left radial or trans-right radial approach in coronary angiography orthotopic heart transplantation patients. However, in this particular setting of patients, the left radial approach might reduce the technical difficulties related to the anatomical variations.~In this single centre, prospective, randomized study, we sought to compare trans right radial versus trans left radial approach in terms of amount of contrast medium, radiation exposure, number of catheters used, cross over to the other access site rate and local and systemic complications in orthotopic heart transplantation patients.", - "NCTID": "NCT02163031" - }, - { - "brief_title": "Venous Site for Central Catheterization", - "phase": "", - "drugs": "['Randomization of the site for catheterization']", - "drugs_list": [ - "Randomization of the site for catheterization" - ], - "diseases": "['Critical Care', 'Catheterization', 'ICU']", - "diseases_list": [ - "Critical Care", - "Catheterization", - "ICU" - ], - "enrollment": "3471.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient admitted in the Intensive Care Unit \n\n Requiring Central Venous Catheterization \n\n ", - "exclusion_criteria": ": \n\n Patients with only one site available", - "brief_summary": "Central venous catheters are needed in the critical care setting to administer drugs. Three sites are available to gain vascular access: subclavian, internal jugular and femoral. Each site has complications, but there is no randomized controlled study which compared the 3 sites.~The investigators hypothesis is that subclavian catheterization reduces the risk of major complications compared to internal jugular or femoral.", - "NCTID": "NCT01479153" - }, - { - "brief_title": "PTA and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia", - "phase": "Phase 2; Phase 3", - "drugs": "['PTA with placement of paclitaxel-eluting stent', 'PTA']", - "drugs_list": [ - "PTA with placement of paclitaxel-eluting stent", - "PTA" - ], - "diseases": "['Peripheral Vascular Disease']", - "diseases_list": [ - "Peripheral Vascular Disease" - ], - "enrollment": "144.0", - "inclusion_criteria": "inclusion criteria: \n\n Written informed consent \n\n Age > 18 years \n\n If female patient with child bearing potential, patient may not be pregnant at the study entry and must utilize reliable birth control for the duration of her participation into the study \n\n Patient is willing and able to comply with the specified follow-up evaluation \n\n Critical Limb Ischaemia, this is Fontaine stage III (ischaemic rest pain) and IV (ischaemic ulcers or gangrene) or Rutherford category 4 (ischaemic rest pain), 5 (minor tissue loss) or 6 (major tissue loss) \n\n Stenotic (>50% luminal loss) or occluded infrapopliteal artery, including the tibiofibular trunk, the anterior tibial artery, the posterior tibial artery and the peroneal artery, with a lesion length \u2264 60 mm \n\n Artery to be treated with a diameter more tham or equal to 2mm and less than or equal to 4mm \n\n Patent common iliac, external iliac, superficial femoral and popliteal artery on the ipsilateral side prior to randomisation, possibly after treatment during the same session \n\n At least one patent crural (anterior tibial, posterior tibial or peroneal) artery with expected unobstructed runoff to ankle level after treatment \n\n ", - "exclusion_criteria": ": \n\n Acute limb ischaemia \n\n Subacute limb ischaemia which requires thrombolysis as first treatment modality \n\n Active bleeding or bleeding diathesis \n\n Recent (less than 3 months) hemorrhagic stroke or other any other CNS abnormality with increased risk of haemorrhage, such as intracranial neoplasm, arteriovenous malformation, intracranial aneurysm or aneurysm repair \n\n Gastrointestinal or genitourinary bleeding of clinical significance within the previous 6 weeks before treatment \n\n Aneurysm in common femoral, superficial femoral or popliteal artery on the ipsilateral side \n\n Revascularization involving the same limb within 30 days prior to the index procedure or planned revascularization of the same limb within 30 days of the index procedure \n\n Previous implanted stent at the index site \n\n Life expectancy of less than 6 months or other factors making clinical follow-up difficult \n\n Known allergy to acetylsalicylic acid (aspirin), clopidogrel, heparin or paclitaxel \n\n Known allergy to contrast media \n\n Known heparin induced thrombocytopenia (HIT type 2) \n\n Patient unable or unwilling to tolerate anticoagulant, anti-platelet therapy or contrast media \n\n Creatinine clearance < 20 ml/min (as derived from Cockcroft-Gault or MDRD formula)unless patient is on hemodialysis \n\n Aneurysm in common femoral, superficial femoral or popliteal artery on the ipsilateral side \n\n Severely calcified lesions with expected resistance to stenting \n\n Poor inflow due to ipsilateral stenoses or occlusions of the iliac or femoropopliteal arteries that cannot be treated during the same session \n\n Significant vessel tortuosity or other parameters prohibiting access to the lesions and/or delivery of the stent \n\n Patients without (expected) distal runoff to the index site \n\n Previous implanted stent at the index site", - "brief_summary": "The purpose of this study is to investigate the performance of paclitaxel-coated balloon expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and occlusions in patients with critical limb ischemia compared to percutaneous transluminal balloon angioplasty (PTA).", - "NCTID": "NCT00471289" - }, - { - "brief_title": "Comparison of the FemoSeal\u00ae Arterial Closure Device to Manual Compression After Coronary Angiography", - "phase": "Phase 4", - "drugs": "['FemoSeal\u00ae', 'Manual compression']", - "drugs_list": [ - "FemoSeal\u00ae", - "Manual compression" - ], - "diseases": "['Coronary Angiography Via Femoral Artery Access']", - "diseases_list": [ - "Coronary Angiography Via Femoral Artery Access" - ], - "enrollment": "1005.0", - "inclusion_criteria": "inclusion criteria: \n\n The patient must be at least 18 years old \n\n Patients undergoing femoral access coronary angiography \n\n Patient must be competent for providing informed, written consent \n\n Only 6F sheath \n\n ", - "exclusion_criteria": ": \n\n Percutaneous coronary intervention \n\n Intra coronary measurements (FFR, IVUS, OCT, NIR) \n\n Groin hematoma before closure \n\n Pseudoaneurysm or AV fistula \n\n Significant stenosis of ilial or femoral artery \n\n Prior peripheral artery surgery \n\n INR > 3,0 \n\n Platelet count < 120 million per millilitre blood \n\n Coagulopathy (bleeding disorder) \n\n Thrombolysis in the last 24h \n\n Planned heparin infusion after the procedure \n\n Pregnancy \n\n Uncontrolled hypertension > 200 mmHg / 110 mmHg \n\n Femoral access device closure in the last 30 days", - "brief_summary": "Is the FemoSeal\u00ae closure device safer and more comfortable than manual compression for femoral artery access closure after coronary angiography?", - "NCTID": "NCT01001663" - }, - { - "brief_title": "Characteristics Predictive of Success and Complications in the Use of Suture-Mediated Closure of Femoral Venous Access", - "phase": "", - "drugs": "['suture mediated closure']", - "drugs_list": [ - "suture mediated closure" - ], - "diseases": "['Cardiac Catheterization']", - "diseases_list": [ - "Cardiac Catheterization" - ], - "enrollment": "250.0", - "inclusion_criteria": "inclusion criteria: \n\n All consented pts. over the age of 18 who received sutured mediated femoral vein following catheterization \n\n ", - "exclusion_criteria": ": \n\n Pt.s who are unable to give consent. \n\n Pts. whose participation in research is contraindicated for medical reasons are excluded.", - "brief_summary": "Suture-mediated closure devices are effective and safe for achieving rapid hemostasis in femoral venous access site and reducing the incidence of complications associated with traditional closure methods. Furthermore, there are predictive factors(such as sheath size, obesity, procedure duration, and anticoagulation status)that we can use to assess the procedure's likelihood of success in various patients.", - "NCTID": "NCT00838175" - }, - { - "brief_title": "Immediate Mobilization After Cardiac Catheterisation", - "phase": "", - "drugs": "['Immediate mobilization', 'Two hours bedrest']", - "drugs_list": [ - "Immediate mobilization", - "Two hours bedrest" - ], - "diseases": "['Vascular Access Complication', 'Comfort']", - "diseases_list": [ - "Vascular Access Complication", - "Comfort" - ], - "enrollment": "2000.0", - "inclusion_criteria": "inclusion criteria: \n\n CAG or PCI performed via the femoral artery \n\n No hematoma in the groin (> 5 cm in diameter) \n\n Heparin reversed with protamine after PCI \n\n ", - "exclusion_criteria": ": \n\n Oozing, bleeding or hematoma \n\n Treatment with Integrilin, ReoPro, or Marevan \n\n Heparin can not be reversed \n\n The patient does not want to participate \n\n Systolic blood pressure > 180 mm Hg after the procedure \n\n BMI> 35 (can be modified if the groin can be assessed in an upright position) \n\n Demented, unconscious patients who do not understand the information for participants.", - "brief_summary": "The purpose of this study is to investigate the frequency of bleeding and haematomas in patients undergoing coronary angiography or percutaneous coronary intervention via femoral artery and mobilized immediately after the procedure, compared to those mobilized after two hours (following the standard regimen). At the same time the investigators will investigate whether it reduces the discomfort being mobilized immediately after the procedure.", - "NCTID": "NCT02069275" - }, - { - "brief_title": "Pragmatic Ischaemic Stroke Thrombectomy Evaluation", - "phase": "", - "drugs": "['Mechanical thrombectomy', 'Intravenous rtPA']", - "drugs_list": [ - "Mechanical thrombectomy", - "Intravenous rtPA" - ], - "diseases": "['Acute Ischaemic Stroke']", - "diseases_list": [ - "Acute Ischaemic Stroke" - ], - "enrollment": "65.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of supratentorial acute ischaemic stroke \n\n Male or nonpregnant female \u226518 years of age \n\n Clinically significant neurological deficit and NIHSS score \u22656. \n\n Eligible for IV rtPA according to standard guidelines and able to be commenced on IV treatment <4.5h after symptom onset. \n\n Enrolment, randomisation and procedure commencement (groin puncture) possible within 90 minutes of the start of IV rtPA treatment (groin puncture maximum 5.5h after stroke onset). \n\n Occlusion of the main middle cerebral artery (MCA) trunk, MCA bifurcation or intracranial internal carotid artery(carotidT, M1 or single proximal M2 branch) demonstrated on CTA, MRA, or DSA. \n\n Interventional device delivery (guide catheter placed beyond aortic arch and angio obtained) can be achieved within 6 hours of onset of the stroke. \n\n Consent of patient or representative. \n\n Independent prior to the stroke (estimated mRS 02) \n\n Expected to be able to be followed up at 3 months \n\n ", - "exclusion_criteria": ": \n\n CT evidence of intracranial haemorrhage, or evidence of extensive established hypodensity on CT. \n\n Clinical history suggestive of subarachnoid haemorrhage even if CT normal. \n\n Known vascular access contraindications e.g. femoral bypass surgery, tight ipsilateral carotid stenosis, unsuitable proximal vascular anatomy likely to render endovascular catheterisation difficult or impossible. \n\n Extracranial ICA occlusion or basilar artery occlusion \n\n Alternative intracranial pathology potentially responsible for the new symptoms \n\n Medical comorbidities which would preclude safe cerebral vessel catheterisation or which are expected to limit life expectancy to <3 months (eg severe cardiac, renal or hepatic failure, significant coagulopathy, metastatic malignancy) \n\n Known allergy to radiological contrast", - "brief_summary": "Ischaemic strokes (those caused by blockage in an artery in the brain caused by a blood clot) can be treated with very early use of clot-busting (thrombolytic) drugs to attempt to restore the blood supply and limit the damage, resulting in an increased proportion of people making a recovery to independence after stroke. However, drug treatment only succeed in restoring blood flow in a minority of people with clots in the larger arteries (10-25% depending on the size of the blood vessel) and these people also have the most severe strokes and highest risk of death or dependence as a result of the stroke. Current best treatment is therefore least effective in the group with the most severe strokes. Devices that can be fed through the blood vessels to either remove or break up the blood clot in the brain vessels can open this type of large artery blockage. However, using these devices is a highly skilled procedure and it takes some time both to set up the necessary facilities (including anaesthetic, nurses and medical support) and to reach the blockage. The extra time that is required to use these devices may mean that brain tissue is already irreversibly damaged. If so, then an individual patient cannot benefit and indeed may be harmed by opening the artery. There are no completed clinical trials comparing the outcome in people treated with standard stroke treatment and those treated with devices. PISTE is a randomised, controlled trial to test whether additional mechanical thrombectomy device treatment improves functional outcome in patients with large artery occlusion who are given IV thrombolytic drug treatment as standard care.", - "NCTID": "NCT01745692" - }, - { - "brief_title": "The Assessment of Right Ventricular Contractility in Response to Sildenafil", - "phase": "Phase 3", - "drugs": "['Sildenafil']", - "drugs_list": [ - "Sildenafil" - ], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Significant pulmonary arterial hypertension (mean pulmonary artery pressure > 25 mm Hg) \n\n Patients aged 4-18 years \n\n Routine cardiac catheterization clinically indicated for deciding therapeutic treatment \n\n Informed assent/consent from patient/parent \n\n ", - "exclusion_criteria": ": \n\n Suprasystemic pulmonary artery pressures \n\n Evidence of right heart failure \n\n History of ventricular arrhythmia \n\n Known vascular access arrhythmia \n\n Contraindication to Sildenafil \n\n Concurrent inotropic / PDE administration \n\n Other medical, psychological or social circumstances which complicate a regular participation in the study, and/or increase the risk for the patients themselves \n\n No consent/assent \n\n Pregnancy or unwillingness to comply with contraceptive advice", - "brief_summary": "The primary objective of this study is to examine the effects of Sildenafil, administered during cardiac catheterization, on right ventricular contractility in children with pulmonary arterial hypertension.", - "NCTID": "NCT00742014" - }, - { - "brief_title": "The Effect of Perioperative Medications on the Outcomes of Patients Undergoing Cardiac Surgery", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cardiac Diseases']", - "diseases_list": [ - "Cardiac Diseases" - ], - "enrollment": "1.0", - "inclusion_criteria": "inclusion criteria: \n\n All cardiac surgical patients \n\n ", - "exclusion_criteria": ": \n\n Non cardiac surgery", - "brief_summary": "This study will be a retrospective study. The patient data from the electronic medical records and existing database will be collected and analyzed. Primary endpoints will be postoperative mortality (within 30 days) and overall complications and length of hospital stay. The secondary endpoints will be myocardial infarction, cardiac death, CHF, arrhythmia, ischemia, stroke, neurological complications, length of ICU stay, re-admission rate, infections, pulmonary complications, length of intubation time, length of ventilation time, and acute renal failure.", - "NCTID": "NCT01683448" - }, - { - "brief_title": "Postoperative Respiratory Depression After Cardiac Surgery", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Coronary Artery Disease']", - "diseases_list": [ - "Coronary Artery Disease" - ], - "enrollment": "44.0", - "inclusion_criteria": "inclusion criteria: \n\n patients of both sexes older than 18 years submitted to CABG with CPB, presence of coronary disease confirmed by coronary angiography, use of the left internal thoracic artery and/or saphena, patients who remained in spontaneous ventilation on the first postoperative day, absence of chronic or acute pulmonary disease, and giving written informed consent to participate in the study. \n\n ", - "exclusion_criteria": ": \n\n intraoperative change of the surgical technique, surgical complications or complications occurring in the ICU, emergency reoperation, renal failure, failure to agree to continue in the study, presence of other types of heart disease, and presence of pulmonary diseases.", - "brief_summary": "Coronary artery bypass graft surgery (CABG) is associated with postoperative respiratory depression. In this study we aimed at investigating perioperative parameters that could predict the nadir of postoperative respiratory function impairment.", - "NCTID": "NCT02074371" - }, - { - "brief_title": "Effects of High Voltage Electrical Stimulation, Shortwave Diathermy and Kinesiotherapy on Arterial Blood Flow in the Lower Limbs of Diabetic Women", - "phase": "", - "drugs": "['high-voltage electrical stimulation', 'Kinesiotherapy', 'shortwave diathermy']", - "drugs_list": [ - "high-voltage electrical stimulation", - "Kinesiotherapy", - "shortwave diathermy" - ], - "diseases": "['Diabetes', 'Peripheral Arterial Disease']", - "diseases_list": [ - "Diabetes", - "Peripheral Arterial Disease" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria: \n\n Women \n\n Diagnosis of diabetes \n\n Diagnosis of peripheral arterial disease \n\n ", - "exclusion_criteria": ": \n\n Regular physical activity \n\n Smokers \n\n Thrombosis active \n\n Severe peripheral arterial disease", - "brief_summary": "Peripheral arterial disease (PAD) is a pathological condition limiting, resulting from a narrowing or occlusion of the artery diameter due to aneurysms, inflammation, atherosclerosis and thromboembolic events. One of the main risk factors for the development of DAP is diabetes mellitus due to its relation to the process of atherogenesis. Thus, the objective of this study is to evaluate the effects of three treatment modalities for PAD on the blood flow velocity. It is a crossover study. Fifteen women with diabetes receive three types of treatment, the order defined according draw: high voltage electrical stimulation, shortwave diathermy and kinesiotherapy. The blood flow of the lower limb will be assessed by Doppler ultrasound. The hypothesis of this study is that physical therapy resources increase the circulation of the lower limb.", - "NCTID": "NCT01868698" - }, - { - "brief_title": "A Comparison of mNT-BBAVF and BCAVF in Hemodialysis Patients", - "phase": "", - "drugs": "['mNT-BBAVF', 'BCAVF']", - "drugs_list": [ - "mNT-BBAVF", - "BCAVF" - ], - "diseases": "['Vascular Fistula']", - "diseases_list": [ - "Vascular Fistula" - ], - "enrollment": "84.0", - "inclusion_criteria": "inclusion criteria: \n\n Age from 18 to 75 years; \n\n Radial artery diameter <2.0 mm or cephalic vein diameter in the forearm <2.5 mm; \n\n Brachial artery diameter \u2265 2 mm \n\n ", - "exclusion_criteria": ": \n\n Stenosis or thrombosis present in the draining vein; \n\n A history of peripheral ischemia in upper extremities; \n\n Active local or systemic infections; \n\n Inability to consent for the procedure; \n\n Patients with previous dysfunctional forearm fistula.", - "brief_summary": "A well-functioning vascular access is essential for effective hemodialysis. The native arteriovenous fistula (AVF) is the preferred vascular access because of the lower thrombosis and infection risks compared to either synthetic arteriovenous grafts or central venous catheters. Brachiocephalic arteriovenous fistula (BCAVF) and transposed brachiobasilic arteriovenous fistula (T-BBAVF) are recommended when there is either a primary failure or no suitable vessels for the forearm fistula. However, BCAVF is frequently cannulated at the antecubital fossa, the risks of stenosis and thrombosis are high, which will compromise proper BCAVF function and survival. T-BBAVF is not only technically challenging, but also associates with severe arm swelling and pain. Thus, the investigators introduced a novel modified Non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) for long-term hemodialysis patients. To confirm its efficacy, a prospective clinical study would be carried out.", - "NCTID": "NCT02519933" - }, - { - "brief_title": "Evaluating the Effect of Surgical Safety Checklists on Perioperative Complications in Children", - "phase": "", - "drugs": "['Surgical Safety Checklist']", - "drugs_list": [ - "Surgical Safety Checklist" - ], - "diseases": "['Intraoperative Complications', 'Postoperative Complications']", - "diseases_list": [ - "Intraoperative Complications", - "Postoperative Complications" - ], - "enrollment": "28772.0", - "inclusion_criteria": "inclusion criteria: \n\n Surgical admission, with a noncardiac surgical interventions \n\n Aged between >28 days and <18years on the day of the surgical intervention \n\n ", - "exclusion_criteria": ": \n\n Non-surgical admission \n\n Surgical interventions with <10 per group \n\n Cardio-thoracic and interventional cardiology procedures", - "brief_summary": "The purpose of this study is to see if the surgical safety checklist is associated with a reduction in perioperative complications for children undergoing surgery in Ontario, Canada.", - "NCTID": "NCT02419053" - }, - { - "brief_title": "Feasibility of Peripheral Angioplasty in Type D TASCII Lesions", - "phase": "", - "drugs": "['PTA BPG procedure,']", - "drugs_list": [ - "PTA BPG procedure," - ], - "diseases": "['Diabetes', 'Critical Limb Ischemia']", - "diseases_list": [ - "Diabetes", - "Critical Limb Ischemia" - ], - "enrollment": "344.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult diabetic patients type 1 or 2 \n\n Chronic critical ischemia as defined by TASC 2007 criteria (pain at rest, and/or ulcer or gangrene due to arteriopathy: transcutaneous oximetry < 30 mmHg or pressure on the ankle < 70 mmHg) \n\n ", - "exclusion_criteria": ": \n\n Cancer with adverse prognosis in months, or chemotherapeutic treatment \n\n Ongoing or planned pregnancy \n\n Lack of consent to participate to the study", - "brief_summary": "This observational prospective study will evaluate, according o usual local clinical practice, feasibility of endoluminal revascularization in diabetic patients with type C and D lesions, according to TASC II Criteria.~About 300 patients will be treated with usual revascularization procedure. Each patient will be followed at least 12 months to evaluate clinical outcome and limb salvage interventions.", - "NCTID": "NCT01297387" - }, - { - "brief_title": "Intracardiac Echocardiography in Atrial Flutter Ablation", - "phase": "Phase 3", - "drugs": "['Intracardiac echocardiography']", - "drugs_list": [ - "Intracardiac echocardiography" - ], - "diseases": "['ATRIAL FLUTTER']", - "diseases_list": [ - "ATRIAL FLUTTER" - ], - "enrollment": "79.0", - "inclusion_criteria": "inclusion criteria: \n\n indication for atrial flutter ablation \n\n ", - "exclusion_criteria": ": \n\n history of recent femoral vein thrombosis (within last 6 months)", - "brief_summary": "Background: Radiofrequency ablation of typical atrial flutter present the most effective treament option in treatment of atrial flutter. Despite its high efficacy, due tovariant anatomy of cavotricuspid isthmus (CTI), i.e. location of right coronary artery, pouches, the achievment of complete bidirectional block across the CTI is sometimes chalenging. Intracardiac echocardiography (ICE) is a very usefull tool for on-line vizualization of the anatomy of the atria and also for the location of catheter position on CTI during ablation. If the routine use of ICE is associated with easier atrial fluter ablation is not clear.~Methods: One hundred consecutive patients indicated for typical atrial flutter ablation will be enrolled into the study. The patients will be randomized into group (A) ablation with use of ICE and (B) ablation without ICE. The ablation will be done in both groups by two diagnostic catheters (10-pole positioned in coronary sinus and 20-pole halo catheter positioned in the right atrium) and radiofrequency ablation catheter. The end-point of the ablation is the achievment of the bicidrectional block across the CTI. The end-points of the study are 1) the total length of the procedure, 2) the fluoroscopy time and 3) the ablation time. The safety end-point is clinically significant bleeding from the groin due to additional puncture for ICE catheter.~Discussion: We hypothesize the use of ICE wil shorten the radiofrequency energy delivery, fluoroscopy time and the length of the procedure without increasing the bleeding.", - "NCTID": "NCT02426710" - }, - { - "brief_title": "Stenting Versus Best Medical Treatment of Asymptomatic High Grade Carotid Artery Stenosis", - "phase": "", - "drugs": "['carotid artery stenting']", - "drugs_list": [ - "carotid artery stenting" - ], - "diseases": "['Asymptomatic', 'Artery']", - "diseases_list": [ - "Asymptomatic", - "Artery" - ], - "enrollment": "148.0", - "inclusion_criteria": "inclusion criteria: \n\n Atherosclerosis is the underlying disease \n\n Patients with an asymptomatic stenosis >80% (NASCET) with a documented progression of the degree of stenosis to >80% within 6 months with a very tight stenosis \u226590% at initial presentation with a >80% stenosis plus silent ipsilateral ischemia documented by CCT or MRI with ipsilateral >80% stenosis plus contralateral >80% stenosis or occlusion with >80% stenosis plus planned major surgery \n\n Neurologist\u00b4s explicit consent to potentially perform CAS \n\n ", - "exclusion_criteria": ": \n\n Inability to provide informed consent \n\n Underlying disease other than atherosclerosis (inflammatory or autoimmune disease) \n\n Traumatic or spontaneous carotid dissections \n\n Life expectancy <6 months \n\n Advanced dementia \n\n Advanced renal failure (serum creatinine >2.5 mg/dL) \n\n Unstable severe cardiovascular comorbidities (e.g. unstable angina, heart failure) \n\n Restenosis after prior CAS or CEA \n\n Allergy or contraindications to study medications (clopidogrel, statins, ASA)", - "brief_summary": "Background. Carotid artery stenting (CAS) recently has become an accepted method for treatment of patients with high-grade carotid artery stenosis, who are at an increased risk for surgical carotid endarterectomy (CEA). The reported rates of neurological complications of CAS substantially decreased during the past years, and the routine use of cerebral protection devices and low profile catheter systems have further increased the procedure\u00b4s safety. In the early 90's large surgical trials in North America and Europe (NASCET, ECST and ACAS) demonstrated superiority of CEA compared to best medical treatment for symptomatic and asymptomatic patients. Provided that the ongoing randomized controlled trials comparing CAS and CEA confirm equivalence between the these methods, CAS similar to CEA is applicable to symptomatic and asymptomatic patients with high grade carotid stenosis. However, particularly in asymptomatic patients, the indication for revascularisation remains debatable. Protected CAS is associated with a very low rate of neurological complications, which are below the AHA recommendation for treating asymptomatic patients (3%). However, the introduction of new vascular protective medications like statins and clopidogrel during the recent years substantially improved the spectrum of best medical treatment, and the findings of NASCET, ECST and ACAS with respect to best medical treatment may therefore not be applicable any more.~Study hypothesis and aims. Given the low frequency of spontaneous neurological complications, the preferable therapeutic approach to patients with asymptomatic high grade ( > 80%) carotid artery stenoses is currently unknown. Modern best medical treatment may manage to stabilize the atherosclerotic plaque, while CAS has the potential of resolving the carotid stenosis. Comparative data, however, are not available as yet. We hypothesized that protected CAS has a beneficial effect on occurrence of ipsilateral neurological complications and major adverse cardiac events in high-risk patients with asymptomatic > 80% internal carotid artery stenosis. Therefore, the aim of the present randomized controlled trial was to analyze neurological and cardiovascular outcome of patients treated with elective CAS plus best medical treatment compared to best medical treatment only.", - "NCTID": "NCT00497094" - }, - { - "brief_title": "The Therapeutical Role of Continuous Intra-femoral Artery Infusion of Urokinase on Diabetic Foot Ulcers", - "phase": "Phase 2", - "drugs": "['continuous intra-femoral thrombolysis group', 'Conventional therapy group']", - "drugs_list": [ - "continuous intra-femoral thrombolysis group", - "Conventional therapy group" - ], - "diseases": "['Diabetic Foot Ulcer']", - "diseases_list": [ - "Diabetic Foot Ulcer" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n diabetic foot ulcer \n\n < = 80 years old \n\n diabetic foot ulcer wegnar 2-4 stage \n\n ", - "exclusion_criteria": ": \n\n Wagner grade 0,1 and grade 5 \n\n severe coronary, cerebral, renal vascular as well as severe liver diseases, malignant neoplasms \n\n bleeding individuals \n\n > 80 years old \n\n heart failure (NYHA 3,4) \n\n cancer", - "brief_summary": "Diabetic foot ulcers (DFU) are one of the chronic consequences of diabetes which constitute the most important cause of non-traumatic amputation of the inferior limbs. Patients with diabetes are 22 times more likely to have foot ulceration or gangrene than nondiabetics\uff0cwhile foot ulceration precedes 85% of lower-extremity amputation.~Three factors combine to promote tissue necrosis in diabetic feet: ischemia, neuropathy and trauma. Among them, ischemia peripheral arterial disease may play the important roles in the development of DFU. Moreover, diffuse vascular disease is the main characteristics, and thus it becomes difficult for treatment by using arterial bypass or balloon angioplasty. Therefore, we hypothesized that continuous arterial thrombolysis may be an effective therapy in diabetic foot. The purpose of this study is to investigate the effectiveness and safety of continuous intra-femoral artery injection of urokinase by micro-artery-pump in diabetic ulcers.", - "NCTID": "NCT01108120" - }, - { - "brief_title": "PROTECT Continued Access Post Marketing Surveillance Trial", - "phase": "Phase 4", - "drugs": "['Endeavor\u00ae Zotarolimus Eluting Coronary Stent System']", - "drugs_list": [ - "Endeavor\u00ae Zotarolimus Eluting Coronary Stent System" - ], - "diseases": "['Coronary Artery Disease, Autosomal Dominant, 1']", - "diseases_list": [ - "Coronary Artery Disease", - "Autosomal Dominant", - "1" - ], - "enrollment": "1018.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient is > 18 years of age (or minimum age as required by local regulations). \n\n The patient or patient's legal representative has consented to participate and has authorized the collection and release of his medical information by signing the Patient Informed Consent Form. \n\n All lesions requiring interventions (target lesions - one to a maximum of four) in one or more native coronary arteries are amendable for implantation of one or more Endeavor\u00ae Zotarolimus Eluting Coronary Stent System. \n\n Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the 'Indications for Use' as mentioned in the 'Instructions for Use' that comes with every Endeavor\u00ae Zotarolimus Eluting Coronary Stent System. Please check the 'Instructions for Use' that comes with the product. Please be aware that the 'Instructions for Use' may be subject to change during the course of the study. \n\n 5 The patient is willing and able to cooperate with study procedures and required follow up visits. \n\n ", - "exclusion_criteria": ": \n\n Women with known pregnancy or who are lactating. \n\n Planned elective surgery necessitating discontinuation of clopidogrel within the regular planned period of clopidogrel administration. \n\n Patients expected not to be compliant with the anti-platelet and/or anticoagulation therapy regimen. \n\n Previous brachytherapy. \n\n Previous implantation of a drug eluting stent. \n\n Previous implantation of a bare metal stent in the preceding year. \n\n Simultaneous or planned intervention other non cardiac vessels including but not limited to renal artery or carotid artery. \n\n Current medical condition with a life expectancy of less than 3 years. \n\n Manifest acute severe heart failure (Killip class III-IV). \n\n The patient is currently, and during the first 3 years of the PROTECT trial, participating in another investigational device or drug study that clinically interferes with the PROTECT-study endpoints; or requires coronary angiography or other coronary artery imaging procedures. The patient may only be enrolled in the PROTECT-study once. \n\n Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this study. \n\n Patients on warfarin or similar anti-coagulant therapy. \n\n Patients with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use. \n\n Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon. \n\n Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated. \n\n 16 Transplant patients.", - "brief_summary": "In order to expand safety information in patients treated with the Endeavor Drug Eluting Stent System, or next generation model, a Continued Access (CA) study is added to the PROTECT Trial. The amended study is PROTECT CONTINUED ACCESS (PROTECT CA).", - "NCTID": "NCT00846846" - }, - { - "brief_title": "Catheter Thrombectomy in Patients With Massive Pulmonary Embolism", - "phase": "Phase 1; Phase 2", - "drugs": "['Mechanical Thrombectomy']", - "drugs_list": [ - "Mechanical Thrombectomy" - ], - "diseases": "['Pulmonary Embolism']", - "diseases_list": [ - "Pulmonary Embolism" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients >= 18 years of age with pulmonary embolism and cardiogenic shock, defined as a systolic arterial pressure <= 90 mmHg, a drop in systolic arterial pressure >= 40 mmHg for >= 15 minutes, or ongoing administration of catecholamines for systemic arterial hypotension \n\n Subtotal or total filling defect in the left and/or right main pulmonary artery due to massive PE, as assessed by chest computed tomography or by conventional pulmonary angiography \n\n Right ventricular dysfunction on echocardiography: RV systolic hypokinesis and/or RV dilation (optional) \n\n Failed thrombolysis or at least one of the following contraindications to PE thrombolysis present: \n\n Active bleeding \n\n History of intracranial bleeding \n\n Surgery, delivery, organ biopsy, puncture of a non-compressible vessel within 10 days \n\n History of stroke \n\n Gastrointestinal bleeding within 10 days \n\n Significant trauma within 15 days \n\n Head injury requiring hospitalization within 1 year \n\n Active cancer with known hemorrhagic risk \n\n Neurosurgery or ophthalmologic surgery within the past year \n\n Platelets < 50,000 or INR >2.0 \n\n Pregnancy \n\n ", - "exclusion_criteria": " \n\n Systemic (paradoxical) embolism in the presence of an atrial septal defect or patent foramen ovale \n\n Free floating right heart thrombi, left heart thrombi \n\n Life expectancy due to underlying disease less than one month", - "brief_summary": "Official Title: Compassionate Use of Catheter Thrombectomy (Aspirex 11F) in Patients With Massive Pulmonary Embolism~Study Population: Patients >/= 18 years of age with massive pulmonary embolism suitable for mechanical thrombectomy with Aspirex 11F.~Treatment: Aspirex 11F assisted thrombectomy~_________~The study was terminated early. After having treated seven (7) patients, it was decided in April 2007 that the handling characteristics of the test device should be upgraded before continuing the trial as planned. Therefore, the study was long-term interrupted and finally terminated early. This decision was made by the sponsor in full accordance with the principal investigator. Further studies shall be conducted to show effectiveness and safety of the Aspirex PE catheter thrombectomy device.~_________~Primary Endpoints:~Thrombectomy with the Aspirex catheter device is associated with an immediate decrease in mean pulmonary artery pressure (PAP) and pulmonary vascular resistance (PVP).~The Aspirex thrombectomy catheter does not cause perforation/dissection to treated and untreated cardiovascular structures.~Secondary Endpoints:~Thrombectomy with the Aspirex catheter device is associated with improved flow in the treated main and lobar pulmonary arteries as assessed by the angiographic Miller index.~There will be no significant mechanical haemolysis as assessed by plasma free haemoglobin levels.~In-hospital mortality will not exceed 20%.~Study Design: A prospective international multicenter non-randomized registry assessing the safety and efficacy of the Aspirex 11F mechanical thrombectomy device.~Sample Size: Maximum of 50 patients~Inclusion Criteria:~Patients with massive pulmonary embolism and cardiogenic shock with failed thrombolysis or at least contraindication for lysis.~Exclusion Criteria:~Systemic embolism in the presence of an arterial septal defect or patent foramen ovale.~Free floating right heart thrombi, left heart thrombi.~Life expectancy, due to underlying disease, less than one month.", - "NCTID": "NCT00314002" - }, - { - "brief_title": "Response To Cardiac Resynchronization Therapy In Heart Failure: Role Of Arterial Stiffness", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Arterial Stiffness']", - "diseases_list": [ - "Arterial Stiffness" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n The patients receiving CRT are medically refractory, symptomatic, NYHA class III or IV disease and QRS duration of 130 m sec or greater, and a left ventricular ejection fraction of 30 percent or less. \n\n All individuals are carefully selected after appropriate clinical evaluation as determined by the treating physicians to exclude possible reversible causes of heart failure. \n\n ", - "exclusion_criteria": ": \n\n Patients with permanent atrial fibrillation and non-palpable carotid and/or femoral pulses will be excluded due to technical limitations of the procedure used for the measurement of arterial stiffness.", - "brief_summary": "To determine if arterial stiffness as measured by non-invasive pulse wave velocity can predict the response to resynchronization therapy in heart failure.", - "NCTID": "NCT00970476" - }, - { - "brief_title": "Randomized Clinical Trial of Polyester vs. Polyurethane Patch for Carotid Endarterectomy", - "phase": "", - "drugs": "['CEA']", - "drugs_list": [ - "CEA" - ], - "diseases": "['Carotid Artery Thrombosis', 'Carotid Artery Stenosis', 'Stroke']", - "diseases_list": [ - "Carotid Artery Thrombosis", - "Carotid Artery Stenosis", - "Stroke" - ], - "enrollment": "450.0", - "inclusion_criteria": "inclusion criteria: \n\n Carotid stenosis > 60% NASCET criteria \n\n ", - "exclusion_criteria": ": \n\n Redo carotid surgery \n\n Radiation induced carotid stenosis \n\n Extensive carotid lesion > 5 cm in length with involvement of the common carotid artery best treated by a carotid bypass", - "brief_summary": "This study examines the risk of thrombogenicity of the carotid patches in polyurethane compared to carotid patches in polyester including death, any stroke, carotid thrombosis at 30 days and long-term results including stroke and recurrent carotid stenosis at 10 years.~This study was run at the University of Roma, La Sapienza and at the University of Poitiers, randomisation was done in both enters after approval by the Ethical committee of the University of Roma (Record uploaded)", - "NCTID": "NCT02341196" - }, - { - "brief_title": "Clinical and Economical Interest of Endovascular Cooling in the Management of Cardiac Arrest (ICEREA Study)", - "phase": "Phase 4", - "drugs": "['Comparison of 2 cooling procedures']", - "drugs_list": [ - "Comparison of 2 cooling procedures" - ], - "diseases": "['Hypothermia', 'Heart Arrest']", - "diseases_list": [ - "Hypothermia", - "Heart Arrest" - ], - "enrollment": "389.0", - "inclusion_criteria": "inclusion criteria: \n\n Age between 18 and 79 years old \n\n Out-of-hospital cardiac arrest (OH-CA) due to a presumed cardiac etiology \n\n Delay between OH-CA and return of spontaneous circulation (ROSC) < 60 minutes \n\n Delay between ROSC and starting cooling < 240 minutes \n\n Patient not obeying verbal command after ROSC and prior to starting cooling \n\n Availability of the CoolGard device (ALSIUS product) \n\n ", - "exclusion_criteria": ": \n\n Do not reanimate order or terminal disease before inclusion \n\n Known pregnancy \n\n Clinical hemorrhagic syndrome or known coagulopathy \n\n Contra-indication to device usage (such as femoral venous access impossible) \n\n Hypothermia at admission < 30\u00b0C \n\n Etiology of OH-CA thought to be extra-cardiac (trauma, bleeding or anoxia) \n\n In hospital cardiac arrest \n\n Refractory shock (need for extra-corporeal life support)", - "brief_summary": "According to international guidelines, mild therapeutic hypothermia is recommended for resuscitated patients after cardiac arrest due to ventricular fibrillation. Whether external or internal cooling is superior in terms of prognosis or security remains unknown. The aim of this study is to evaluate in a randomized trial the clinical and economical interests of the endovascular cooling versus the conventional external cooling for the management of hypothermia after cardiac arrest.", - "NCTID": "NCT00392639" - }, - { - "brief_title": "Sirolimus-eluting Stents With Biodegradable Polymer Versus an Everolimus-eluting Stents", - "phase": "", - "drugs": "['Sirolimus-eluting stent with a bioresorbable polymer (Orsiro)', 'Everolimus-eluting stent with a durable polymer']", - "drugs_list": [ - "Sirolimus-eluting stent with a bioresorbable polymer (Orsiro)", - "Everolimus-eluting stent with a durable polymer" - ], - "diseases": "['Coronary Artery Disease', 'Angina Pectoris', 'Myocardial Infarction']", - "diseases_list": [ - "Coronary Artery Disease", - "Angina Pectoris", - "Myocardial Infarction" - ], - "enrollment": "2119.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u226518 years \n\n Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including NSTE-ACS and STE-ACS \n\n Presence of one or more coronary artery stenoses >50% in a native coronary artery or a saphenous bypass graft which can be treated with a stent ranging in diameter from 2.25 to 4.0 mm and can be covered with one or multiple stents \n\n No limitation on the number of treated lesions, and vessels, and lesion length \n\n ", - "exclusion_criteria": " \n\n Pregnancy \n\n Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Sirolimus, Everolimus or contrast material \n\n Inability to provide informed consent \n\n Currently participating in another trial before reaching first endpoint \n\n Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period", - "brief_summary": "Coronary artery stents have improved the safety and efficacy of percutaneous coronary intervention for coronary artery disease. Drug-eluting stents have been shown to decrease neointimal hyperplasia and to reduce the rate of restenosis and target-lesion revascularization as compared to bare-metal stents. Drug-eluting stents consist of a metallic platform and a therapeutic substance that is usually released from a polymer matrix. A previous study utilizing a bioresorbable polymer has demonstrated a favorable safety and efficacy profile in a large-scale clinical trial as compared to a first-generation druf-eluting stent (LEADERS trial).~The objective of the study is to compare the safety and efficacy of a sirolimus-eluting stent with a biodegradable polymer with an everolimus-eluting stent with a durable polymer in a prospective multicenter randomized controlled non-inferiority trial in patients undergoing percutaneous coronary intervention in routine clinical practice.", - "NCTID": "NCT01443104" - }, - { - "brief_title": "Pulmonary Artery Denervation for Treatment of Pulmonary Arterial Hypertension", - "phase": "", - "drugs": "['denervation', 'sham procedure']", - "drugs_list": [ - "denervation", - "sham procedure" - ], - "diseases": "['Pulmonary Arterial Hypertension']", - "diseases_list": [ - "Pulmonary Arterial Hypertension" - ], - "enrollment": "1.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with pulmonary artery hypertension (group 1 of the Nice classification of pulmonary hypertension) \n\n Aged over 18 years old \n\n NYHA class III or IV \n\n Not controlled by optimal medical management as defined by: \n\n dual therapy including a prostacyclin. \n\n or dual therapy including an endothelin receptor antagonist and a \n\n 5-phosphodiesterase inhibitors, in patients with contra-indication of prostacyclin, poor tolerance to this treatment, prostacyclin derivative treatment failure or patient refusal. \n\n Valid status in the social security system \n\n Signed informed consent \n\n ", - "exclusion_criteria": ": \n\n Patient eligible for pulmonary transplantation \n\n Pregnancy or breastfeeding \n\n Adults of the age of majority subject to guardianship court order or deprived of liberty \n\n Patient with history of radio frequency procedure \n\n Known heparin allergy", - "brief_summary": "Pulmonary hypertension is a rare condition that leads to right ventricular dysfunction and premature death. Only modest improvements of outcomes have been observed with the current available advanced specific drug therapy. Pulmonary hypertension advanced therapy is also expensive and leads to frequent adverse effects, sometimes serious. Results from a pilot study, the first-in-man experience of pulmonary artery denervation, demonstrated a clinical improvement in 13 patients with severe pulmonary hypertension despite optimal medical management. However this single non-randomized study requires confirmation.~The investigators propose a prospective multi-center, randomized, single-blinded trial. Its main objective will be to assess, in patients with uncontrolled pulmonary hypertension despite optimal medical management, the efficacy of pulmonary artery denervation in reducing mean pulmonary artery pressure (mPAP) at six months, compared to continued medical treatment following a simulated (sham) procedure.~The principal evaluation criteria will be the mPAP change (in mm Hg) as measured by right heart catheterization.~The study will run for 18 months and it will be necessary to recruit 50 patients.~All adult patients (with the exception of pregnant women and individuals unable to receive an appropriate information and to give their free and informed consent) with uncontrolled pulmonary arterial hypertension despite optimal medical management will be invited to participate, in the absence of any exclusion criteria.~The investigators will also measure changes in clinical, biological, echocardiographic and hemodynamic prognostic markers in both groups.", - "NCTID": "NCT02525926" - }, - { - "brief_title": "Renal Denervation in Patients With Heart Failure and Severe Left Ventricular Dysfunction.", - "phase": "", - "drugs": "['Catheterised renal denervation']", - "drugs_list": [ - "Catheterised renal denervation" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients over 18 years of age with chronic heart failure, ischemic and non-ischemic etiology. \n\n NYHA (New York Heart Association) class II-IV. \n\n LVEF (Left Ventricular Ejection Fraction) \u2264 35%. \n\n Patients treated with maximum tolerated doses of standard pharmacotherapy for heart failure, who were stable for at least four weeks without acute decompensated heart failure. \n\n Prior to enrollment, patients must give informed consent. \n\n ", - "exclusion_criteria": ": \n\n Patients with history of acute coronary syndrome or stroke within the last 6 months. \n\n Significant valvular defects and/or planned cardiac surgery. \n\n Systolic blood pressure <110 mmHg. \n\n Advanced renal insufficiency (estimated GFR (Glomerular Filtration Rate) according to MDRD <30 ml/min/1.73 square meters). \n\n Unsuitable anatomy of renal arteries (presence of significant renal stenosis, renal artery narrower than 4 mm). \n\n Patients who underwent renal angioplasty or stent placement into the renal artery in the past. \n\n Severe coagulation disorders. \n\n Pregnancy or lactation. \n\n Refusal of the patient. \n\n Other diseases limiting prognosis of the patient to less than 2 years. \n\n Other reasons which in the opinion of the attending physician would preclude the individual from participating in the study.", - "brief_summary": "It is a randomized prospective controlled study evaluating the effect of transcatheter renal denervation on the clinical status of patients with chronic heart failure and its safety procedures. The working hypothesis of the study is that by performing transcatheter renal denervation in patients with chronic heart failure and severe left ventricular systolic dysfunction there will a resultant reduction in the renal sympathetic activation which in turn will reduce the number of hospitalizations and deaths from heart failure.", - "NCTID": "NCT01870310" - }, - { - "brief_title": "Monitoring of Tissue Transfer Flaps by Modulated Imaging (MI) Spectroscopy", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Reconstructive Surgical Procedures', 'Tissue Transplantation']", - "diseases_list": [ - "Reconstructive Surgical Procedures", - "Tissue Transplantation" - ], - "enrollment": "26.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult patients planned to undergo reconstructive surgery using either a pedicle or free tissue transfer flap seen by The Plastic Surgery Service on either an in-patient or outpatient bases. \n\n Adult patients that are planned to undergo reconstructive surgery as above and able to receive information regarding the study and provide informed consent to enrollment in the study. \n\n ", - "exclusion_criteria": " \n\n All emergency reconstructive surgery patients. \n\n Patients planned to undergo radiation therapy in the region of the reconstructive surgery within 6 months after surgery. \n\n Patients who develop hypotension requiring the administration of vasopressors either intra-operatively or during the post-operative period prior to discharge from the hospital. \n\n Patients who develop clinical signs of a surgical site infection at the location of the tissue transfer flap(s). \n\n Patients with the development of post-operative anemia requiring a blood transfusion during the first 72 hours after surgery. \n\n Patients with tattooing or pigmented lesions on the tissue transfer flap. \n\n Patients who incur injury to the flaps secondary to trauma within 6 months of the reconstructive surgery; with trauma defined as either accidental major trauma resulting in injury to the tissue transfer flap or surgical trauma as a result of further oncologic resection of tissues in close proximity to the tissue transfer flap. \n\n Minor under the age of 18 years of age. \n\n Patients deemed unable to comprehend and provide informed consent to enrollment into study due to either a cognitive deficit or medical condition.", - "brief_summary": "Tissue transfer flaps are a method of moving tissue from a donor location to a recipient location. In the case of a free tissue transfer flaps, the blood vessels to the transferred tissues are detached and then re-attached to different arteries & veins at the recipient site. The process of reconstructive surgery using tissue transfer flaps allows for improved results in terms of functionality, aesthetic appearance, and psychological well-being in patients requiring reconstructive surgery after cancer resection or trauma. The process of reconstructive surgery using tissue transfer flaps is not without complications. These complications may include acute arterial or venous occlusion, as well as the development of late complications such as fat necrosis and flap atrophy.~The purpose of this pilot study is to determine if a novel, unique, portable, non-contact optical imaging device developed at the Beckman Laser Institute called Modulated Imaging (MI) can detect changes in a flap's optical properties, which can correlate with arterial or venous occlusion or with the development of fat necrosis or flap atrophy. The study would also evaluate if changes in the tissue transfer flap's optical properties, as detected by the device could be employed as a monitoring device in the post-operative period after reconstructive surgery. The MI device's detection of specific optical properties of a tissue flap could also potentially be used as a diagnostic tool to predict the likelihood of the development of fat necrosis or flap atrophy in a delayed fashion several months after reconstructive surgery.~Prior animal and clinical studies using similar devices have demonstrated that changes in the total hemoglobin concentration and percentage of oxygenated hemoglobin in the tissue transfer flap can be used to differentiate between arterial and venous occlusion. These other similar devices have been shown to be able to detect venous occlusion prior to clinical manifestations of venous occlusion using standard monitoring methods. This early detection of venous occlusion has important implications. It is well established that early detection and surgical re-exploration and correction of venous occlusion is associated with improved survival and salvage rates of tissue transfer flaps. It has been suggested in the reconstructive literature that the development of fat necrosis and flap atrophy are caused by a relative arterial or venous insufficiency, which could be detected using the MI device prior to the clinical manifestations of these complications.Patients undergoing reconstructive surgery at UCI Medical Center will be recruited for enrollment into the study. The study design requires following the patients and review their medical records in order to determine the clinical outcomes of their reconstructive surgery. The process of review of the medical record will require the review of both the in-patient medical record during the hospitalization in which the reconstructive surgery takes place and the outpatient medical record after surgery in order to observe for the possible development of the acute and delayed complications of reconstructive surgery.", - "NCTID": "NCT00633503" - }, - { - "brief_title": "Fibrin Based Adhesive for the Prevention of Surgical Complications in the Kidney Transplantation", - "phase": "Phase 3", - "drugs": "['Fibrin Glue']", - "drugs_list": [ - "Fibrin Glue" - ], - "diseases": "['Vascular Postoperative Complications', 'Urological System Complication of Procedure', 'Lymphocele', 'Postoperative Infection']", - "diseases_list": [ - "Vascular Postoperative Complications", - "Urological System Complication of Procedure", - "Lymphocele", - "Postoperative Infection" - ], - "enrollment": "152.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients candidates to renal transplantation \n\n ", - "exclusion_criteria": ": \n\n Patients with known allergy to products of fibrin seal", - "brief_summary": "Globally there have been about 45,000 kidney transplants last year. Currently, the overall survival of renal transplant receptors is 95% in the first year and 85% at 5 years. A major challenge to overcome by the renal transplant surgeons, are surgical complications which may impact on patient morbidity and mortality, as well as graft function.~The aim of the study is to assess whether application of fibrin seal prevents postoperative complications in patients undergoing kidney transplantation.~Controlled clinical trial with single-blind evaluation in patients surgically intervened kidney transplantation. It will include all patients undergoing renal transplantation in this Medical Center, any gender and over than 16 years and under 60 years.", - "NCTID": "NCT01631448" - }, - { - "brief_title": "Continuous Adductor Canal Blocks Vs. Low Dose Femoral Nerve Blocks For Early Rehabilitation After Total Knee Arthroplasty", - "phase": "Phase 4", - "drugs": "['Continuous Femoral Nerve Block', 'Nerve Block, Continuous Adductor Canal', 'Continuous Sciatic Nerve Block', 'Bupivacaine']", - "drugs_list": [ - "Continuous Femoral Nerve Block", - "Nerve Block", - "Continuous Adductor Canal", - "Continuous Sciatic Nerve Block", - "Bupivacaine" - ], - "diseases": "['Pain, Postoperative', 'Total Knee Arthroplasty (TKA)']", - "diseases_list": [ - "Pain", - "Postoperative", - "Total Knee Arthroplasty (TKA)" - ], - "enrollment": "62.0", - "inclusion_criteria": "inclusion criteria: \n\n Able to consent to regional anesthesia and having primary total knee arthroplasty/replacement \n\n ", - "exclusion_criteria": ": \n\n Body-Mass Index >40 \n\n Iliac to Patella Distance (IPD) <40cm \n\n Pre-existing quadriceps weakness of involved surgical side Chronic opioid use (if using opioids within 4 weeks of surgery: excluded)", - "brief_summary": "Recently, several articles have suggested or reported that Adductor Canal Blocks (ACBs) offer adequate or equal analgesia and may promote better performance in early rehabilitation following Total Knee Arthroplasty (TKA) when compared to the more commonly used Femoral Nerve Block (FNB). A common feature of these studies has been the use of moderate to high concentration local anesthetics (e.g. 0.2% or 0.5% Ropivacaine respectively) which when injected by a large motor nerve will inevitably cause weakness. However, the practice at our institution has long been a continuous femoral nerve block (CFNB) with a lower concentration local anesthetic (0.0625% Bupivacaine). Over the past several years the investigators have performed several thousand CFNBs using this technique which has offered the advantage of minimal motor weakness and adequate analgesia.~The primary goal of this study is to determine if our established practice of using a low concentration continuous FNB inserted about 5cm caudal to the groin crease (the apex of the femoral triangle) using a low infusion rate of 2ml/hr is comparable to the emerging practice of inserting a Continuous Peripheral Nerve Block (CPNB) in the anatomic adductor canal (AC) - infusing at 4ml/hr. A secondary goal is to study the effect of cumulative volume of local anesthetic infused through a FNB when at a rate of 2ml/hr compared to a rate of 4ml/hr in the 48-hour postoperative period.~Definitions of the location of the adductor canal are debated heavily in literature, but they seem to agree that the middle 1/3 of the thigh contains the proximal AC while the distal 1/3 of the thigh contains the adductor hiatus - the terminal end of the AC. Our study will require placement of the continuous ACB no more distal than 20cm cephalad to the superior pole of the patella due to placement prior to surgery and the need to keep the dressing out of the operative field. The CACB catheter will also not be placed any more proximal than 20cm distal to the ASIS. In addition to other exclusion criteria, these measurements will create an exclusion for patients with an iliac-to-patella distance less than 40cm. Iliac to Patella distance (IPD) will be measured at the pre-operative interview on the day of surgery with a measuring tape. External palpable landmarks of the Anterior superior iliac spine and the superior pole of the patella will be used.~The primary outcome is based upon the ability to perform rehabilitation exercises postoperatively to the extent that criteria for discharge can be met. The primary outcome measured is the time at which a patient gains the ability to successfully perform a 75-feet unassisted walk. On the Day of Surgery (DOS), prior to any walking attempt, a secondary outcome measure will be to perform a 5-second sustained straight leg raise. Other secondary outcomes will be the number of days admitted prior to discharge, and average pain scores on DOS, Postoperative Day (POD) #1, and POD#2. The Day of discharge will also be used as a secondary outcome. Earlier discharge is becoming a goal of almost all healthcare systems to minimize costs.", - "NCTID": "NCT02453321" - }, - { - "brief_title": "Evaluation of Residual Urine After Intermittent Catheterisation", - "phase": "", - "drugs": "['Intermittent catheter', 'Compact intermittent catheter']", - "drugs_list": [ - "Intermittent catheter", - "Compact intermittent catheter" - ], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "36.0", - "inclusion_criteria": "inclusion criteria: \n\n Male \n\n 18 years and above \n\n A negative urine dip-stick \n\n Have signed informed written consent to participate \n\n ", - "exclusion_criteria": ": \n\n The test participant has previous or current congenital deformity, diseases or operation in the lower urinary tract", - "brief_summary": "Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent catheters. The study is a randomized, single blinded, crossover study including 24 healthy males.", - "NCTID": "NCT00324233" - }, - { - "brief_title": "Study Of Angiomax In Infants Under Six Months With Thrombosis", - "phase": "Phase 2", - "drugs": "['Angiomax (bivalirudin)']", - "drugs_list": [ - "Angiomax (bivalirudin)" - ], - "diseases": "['Thrombosis']", - "diseases_list": [ - "Thrombosis" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n Parent/legal-guardian has provided written informed consent before initiation of any study related procedures. \n\n Objectively confirmed thrombotic event by either doppler ultrasound, echocardiogram, CT scan, MRI, MR angiogram, MR venogram, venogram or arteriogram. \n\n Age less than 6 months . \n\n Gestational age greater than 35 weeks \n\n Expected life expectancy at least 14 days. \n\n No contraindication to anticoagulation i.e. bleeding complications. \n\n ", - "exclusion_criteria": ": \n\n Active or recent (less than 7 days) bleeding. \n\n Known allergy to Angiomax or hirudin, or known sensitivity to any component of the product. \n\n Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment. \n\n Refusal to undergo blood transfusion should it become necessary. \n\n Any other disease or condition, which, in the judgment of the Investigator would place a patient at undue risk by being enrolled in the trial. \n\n Baseline prolonged PT (>18 secs) or aPTT (>55 secs) \n\n Platelet count < 50,000 cells/mm3 \n\n Birth Trauma \n\n Planned or indicated surgery within 30 days \n\n Major or minor bleeding event", - "brief_summary": "The goals of this study are:~To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;~To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis;~To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).", - "NCTID": "NCT00043277" - }, - { - "brief_title": "Effects of Acute Systemic Inflammation on Arterial Stiffness and Microcirculation.", - "phase": "", - "drugs": "['NA : non interventional study']", - "drugs_list": [ - "NA : non interventional study" - ], - "diseases": "['Severe Sepsis']", - "diseases_list": [ - "Severe Sepsis" - ], - "enrollment": "8.0", - "inclusion_criteria": "inclusion criteria: \n\n Control group : \n\n male or female aged at least 18 years, matched on age, sex and cardiovascular risk factors (smoking, hypertension, diabetes and treated dyslipidemia) with septic patients \n\n Normal clinical examination and normal 12-lead ECG \n\n Routines biological tests in the normal range of the laboratories. \n\n Body mass index between 18 and 27 kg/m\u00b2 \n\n Written informed consent \n\n Patients group : \n\n Male or female aged at least 18 years \n\n Severe sepsis defined by the presence of: \n\n a systemic inflammatory response syndrome \n\n the evidence of an infection \n\n the presence of at least one organ failure or signs of tissue hypoperfusion. \n\n Body mass index between 18 and 27 Kg/m\u00b2 \n\n Written informed consent from the patients or their relatives \n\n ", - "exclusion_criteria": ": \n\n Control group : \n\n legal protection or persons deprived of liberty \n\n bacterial or viral infection in the month preceding inclusion \n\n current medication \n\n pregnancy or breastfeeding \n\n exclusion period stated on the national register for persons who participate to biomedical research \n\n Patients group : \n\n legal protection or persons deprived of liberty \n\n vasopressor therapy \n\n bacterial or viral infection in the month preceding inclusion \n\n known cardiomyopathy \n\n pregnancy or breastfeeding", - "brief_summary": "This study aims to assess the effect of acute inflammation on arterial stiffness and microcirculation. Patients with severe sepsis will be compared with age-, sex- and cardiovascular risk factors-matched controls.~The primary outcome is the carotid-femoral pulse wave velocity. The other outcome measures are: systemic hemodynamics (systolic, diastolic, mean and pulse blood pressures, heart rate, cardiac output, left ventricular ejection fraction, systemic vascular resistances), central hemodynamics (aortic systolic, diastolic, mean and pulse pressures, and augmentation index), thenar tissue oxygen saturation, biological makers of inflammation (plasma fibrinogen, C-reactive protein, interleukin-6, matrix metalloproteinases -2, -9, tissue inhibitor of metalloproteinase 1), and plasma catecholamine concentrations (epinephrine, norepinephrine).", - "NCTID": "NCT01556373" - }, - { - "brief_title": "BES, EES, and ZES-R in Real World Practice", - "phase": "", - "drugs": "['Biolimus-eluting stent', 'Everolimus-eluting stent', 'Zotarolimus-eluting stent']", - "drugs_list": [ - "Biolimus-eluting stent", - "Everolimus-eluting stent", - "Zotarolimus-eluting stent" - ], - "diseases": "['Coronary Artery Disease']", - "diseases_list": [ - "Coronary Artery Disease" - ], - "enrollment": "1960.0", - "inclusion_criteria": "inclusion criteria \n\n Age > 19 years \n\n Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the drug-eluting stent(s) and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure \n\n Subject must have significant stenosis (>50% by visual estimate) on a native or in-stent coronary artery \n\n Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, acute myocardial infarction, positive functional study or a reversible changes in the ECG consistent with ischemia). In subjects with coronary artery stenosis >75%, evidence of myocardial ischemia does not have to be documented \n\n ", - "exclusion_criteria": " \n\n Subject has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, prasugrel, ticagrelor, biolimus A9, everolimus, zotarolimus, stainless steel, cobalt chromium, contrast media (Patients with documented sensitivity to contrast media, which can be effectively premedicated with steroid and diphenhydramine may be enrolled. However, those with true anaphylaxis to prior contrast media should not be enrolled.) \n\n Subject in use of systemic (intravenous) biolimus A9, everolimus or zotarolimus within 12 months. \n\n Female subject of childbearing potential, unless a recent pregnancy test is negative, who possibly plans to become pregnant any time after enrollment into this study \n\n Subject planned an elective surgical procedure that would necessitate interruption of antiplatelet during the first 12 months post enrollment \n\n Subject with non-cardiac co-morbid condition with life expectancy < 2 year or that may result in protocol non-compliance (per site investigator's medical judgment) \n\n Subject with cardiogenic shock at presentation \n\n Subject who are actively participating in another drug or device investigational study, who have not completed the primary end point follow-up period", - "brief_summary": "The primary objective of this study is to compare the rate of device-oriented composite consisted of cardiac death, myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target lesion revascularization among the patients treated with EES, ZES-R, or BES at 24-month clinical follow-up post-index procedure. Trial end points are summarized in Table I. The hypothesis is that BES is equivalent to EES or BES is equivalent to ZES-R at the primary end point.", - "NCTID": "NCT01397175" - }, - { - "brief_title": "Arterial Elasticity: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cardiovascular Diseases', 'HIV']", - "diseases_list": [ - "Cardiovascular Diseases", - "HIV" - ], - "enrollment": "337.0", - "inclusion_criteria": "inclusion criteria: \n\n Simultaneous co-enrollment in the START study \n\n Signed informed consent \n\n ", - "exclusion_criteria": ": \n\n Inability to ascertain waveform measurements that can be analyzed, i.e. atrial fibrillation", - "brief_summary": "The purpose of this study is to find out if starting anti-retroviral therapy (ART) above 500 cluster-of-differentiation-4 (CD4)+ cells/milliliter (mL) ('early ART group') is better at reducing the stiffness of arteries than waiting to start ART until the CD4+ drops below 350 cells/mL ('deferred ART group'). Artery stiffness has been associated with an increased risk of cardiovascular (heart) disease, and could be useful as an earlier indicator of heart disease. In this study, the stiffness of arteries will be measured at study entry, months 4, 8, 12, and annually thereafter, using a tonometer on the participant's forearm.", - "NCTID": "NCT01776151" - }, - { - "brief_title": "PENELOPE Observational Study: Prophylaxis and Treatment of Arterial and Venous Thromboembolism", - "phase": "", - "drugs": "['Observation']", - "drugs_list": [ - "Observation" - ], - "diseases": "['Hematologic Neoplasm', 'Acute Leukemia', 'Myelodysplastic Syndrome', 'Lymphoma', 'Multiple Myeloma']", - "diseases_list": [ - "Hematologic Neoplasm", - "Acute Leukemia", - "Myelodysplastic Syndrome", - "Lymphoma", - "Multiple Myeloma" - ], - "enrollment": "99.0", - "inclusion_criteria": "inclusion criteria: \n\n Potential subjects must satisfy all of the following criteria to be enrolled in the study: \n\n diagnosis of hematologic neoplasm (acute leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma, chronic myeloid leukemia, Ph-negative chronic myeloproliferative neoplasms) independently of the stage of disease or treatment (including transplant procedures); \n\n platelet count <50 x109/L at the time of starting antithrombotic prophylaxis or \n\n platelet count <50 x109/L at the time of diagnosis of arterial or venous thromboembolism objectively proven or \n\n platelet count >50 x109/L at time of thrombosis but subsequent thrombocytopenia <50 x109/L while receiving antithrombotic treatment; \n\n diagnosis of arterial thrombosis include acute coronary syndrome, ischemic stroke (including major and minor stroke), peripheral arterial thrombosis, retinal arterial thrombosis; \n\n diagnosis of venous thrombosis include thrombosis of deep veins of the limbs and the abdomen, superficial veins of limbs, cerebral and splanchnic veins, retinal vein, and pulmonary embolism. Splanchnic venous thrombosis include occlusion of hepatic, portal, mesenteric, and splenic veins. \n\n ", - "exclusion_criteria": ": \n\n The following situations will not be criteria of inclusion neither outcomes of interest: \n\n transient ischemic attack without CT and/or NMR signs; \n\n superficial vein thrombosis without Doppler ultrasound examination showing evidence of thrombosis; \n\n antithrombotic prophylaxis only local for central venous lines (i.e. CVC flushing with heparin); \n\n occlusion of the central venous catheter (notice that CVC-related deep venous thrombosis, i.e. thrombosis of the deep veins where the central line is placed, will be a criterion of inclusion or an outcome of antithrombotic prophylaxis).", - "brief_summary": "The primary objective of the study is to assess efficacy and safety of different prophylactic or therapeutic antithrombotic approaches in patients with hematologic neoplasms and platelet count <50 x109/L, including unfractionated or low molecular weight heparin, fondaparinux, anti-vitamin K agents, antiplatelet agents, novel oral anticoagulants, fibrinolytic agents, with or without a policy of platelet transfusion. Cases with arterial or venous thromboembolism managed with observation or use of vena cava filters in patients with venous thromboembolism will be included too.", - "NCTID": "NCT01855698" - }, - { - "brief_title": "Safety and Feasibility of Endovascular Cooling Device in Patients With Hypothermic Cardiopulmonary Resuscitation", - "phase": "", - "drugs": "['ICY catheter, Thermoguard device']", - "drugs_list": [ - "ICY catheter", - "Thermoguard device" - ], - "diseases": "['Cardiac Arrest']", - "diseases_list": [ - "Cardiac Arrest" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria: \n\n Non-traumatic collapsed patients, whose pulsation continues and persists more than 5 minutes after return of spontaneous circulation from cardiopulmonary resuscitation and consciousness level is less than GCS 5 points. \n\n ", - "exclusion_criteria": ": \n\n 1. Age > 78 y/o or < 18 y/o 2. Core temperature< 34\u2103or > 38 \u2103 after resuscitation 3. Pregnancy 4. Underline terminal malignancy disorder or refuse aggressive treatment cancer patient 5. Massive bleeding, known coagulopathy, or received regular anticoagulant medication 6. Persisted hypotension ( mean arterial BP < 60 mmHg) after resuscitation even under inotropic agents 7. No bed available in ICU", - "brief_summary": "Hypothermic resuscitation is proven to be benefit to the cardiac origin cardiac arrest patients for it improve brain recovery dramatically. However, traditional cooling devices and methods, most external cooling methods, include ice blanket, cooling helmet, or ice packing lower the body temperature slowly or inefficiently which make many emergency physicians hesitate to perform hypothermic resuscitation. To improve and promote the practice of hypothermia resuscitation, more efficient temperature control method is necessary. We conduct this clinical trial to evaluate the safety and feasibility of internal cooling catheter and temperature regulatory device, which is approved by FDA in neurologic ICU for temperature control, in the cardiac arrest patients.", - "NCTID": "NCT00154674" - }, - { - "brief_title": "Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence", - "phase": "Phase 2", - "drugs": "['Cooling gel pack', 'Cooling cotton pack']", - "drugs_list": [ - "Cooling gel pack", - "Cooling cotton pack" - ], - "diseases": "['Leg Ulcer', 'Venous Hypertension Ulcers', 'Venous Stasis Ulcer', 'Venous Ulcer', 'Venous Insufficiency', 'Foot Ulcer', 'Varicose Ulcer', 'Diabetic Foot']", - "diseases_list": [ - "Leg Ulcer", - "Venous Hypertension Ulcers", - "Venous Stasis Ulcer", - "Venous Ulcer", - "Venous Insufficiency", - "Foot Ulcer", - "Varicose Ulcer", - "Diabetic Foot" - ], - "enrollment": "140.0", - "inclusion_criteria": "inclusion criteria: \n\n Newly healed leg or diabetic foot ulcer within past 7 - 14 days \n\n Ankle brachial index 0.8- 1.3mmHg (rule out absence of arterial disease) \n\n Willing to wear compression stockings and appropriate footwear \n\n Working freezer \n\n ", - "exclusion_criteria": ": \n\n Open leg or foot ulcers \n\n Cognitive impairment: unable to recall 2 or more words or draw clock Mini-Cog\u2122 for cognitive impairment \n\n Chronic inflammatory or vascular conditions where blood flow of skin may be impaired such as Lupus erythematosus, Raynaud's, scleroderma, end stage renal disease, chronic regional pain syndrome, multiple sclerosis, hypersensitivity to cold, on chemotherapy \n\n Unable to preform required protocol activities without assistance (return demonstration to study staff)", - "brief_summary": "The goal of this study is to test MUSTCOOL, a home-based self-monitoring and self-management ulcer prevention intervention for patients with newly healed chronic venous leg and diabetic foot ulcers. Almost 90% of ulcers recur within 3 months of healing. During the six-month randomized clinic trial, skin temperature will be monitored daily, a maintenance dose of cooling gel pack or placebo will be applied three times weekly to the affected skin, and a bolus dose of cooling will be applied for 5 consecutive days if skin temperature becomes elevated. Outcomes on the incidence of leg ulcer recurrence, pain, physical activity and quality of life will be measured.", - "NCTID": "NCT02626156" - }, - { - "brief_title": "Use of Activated Recombinant FVII in Spinal Surgery", - "phase": "Phase 2", - "drugs": "['eptacog alfa (activated)']", - "drugs_list": [ - "eptacog alfa (activated)" - ], - "diseases": "['Acquired Bleeding Disorder', 'Spinal Fusion']", - "diseases_list": [ - "Acquired Bleeding Disorder", - "Spinal Fusion" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Elective spinal fusion surgery. \n\n ", - "exclusion_criteria": ": \n\n History of thrombotic disorders (myocardial infarction, deep vein thrombosis, pulmonary embolism, stroke, disseminated intravascular coagulation or peripheral artery thrombosis) \n\n Any trauma within the last 3 months leading to hospitalization > 24 hours \n\n Angina or known coronary artery disease", - "brief_summary": "This trial is conducted in the United States of America (USA). The purpose of this clinical research trial is to understand how safe and effective Recombinant Activated FVII is for reducing bleeding and blood transfusions in patients undergoing spinal fusion surgery.", - "NCTID": "NCT00102037" - }, - { - "brief_title": "COOL-Trial: Outcome With Invasive and Non-invasive Cooling After Cardiac Arrest", - "phase": "Phase 4", - "drugs": "['Coolgard', 'ArcticSun', 'Conventional treatment']", - "drugs_list": [ - "Coolgard", - "ArcticSun", - "Conventional treatment" - ], - "diseases": "['Cardiac Arrest', 'Hypothermia']", - "diseases_list": [ - "Cardiac Arrest", - "Hypothermia" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n ROSC after SCA due to VF/VT or PEA/Asystolia \n\n GCS 3 \n\n ", - "exclusion_criteria": ": \n\n Non-cardiac SCA \n\n Pregnancy \n\n Unstable Circulation instead of High-dose Inotropics \n\n Life-expectancy reducing concomitant illness", - "brief_summary": "Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. The investigators evaluated the efficacy and side effects of therapeutic hypothermia in an unselected group of patients after SCA.", - "NCTID": "NCT00843297" - }, - { - "brief_title": "Comparing Therapeutic Hypothermia Using External and Internal Cooling for Post-Cardiac Arrest Patients", - "phase": "Phase 4", - "drugs": "['Internal Cooling', 'External Cooling']", - "drugs_list": [ - "Internal Cooling", - "External Cooling" - ], - "diseases": "['Cardiac Arrest']", - "diseases_list": [ - "Cardiac Arrest" - ], - "enrollment": "51.0", - "inclusion_criteria": "inclusion criteria: \n\n Sustained return of spontaneous circulation (ROSC) after cardiac arrest, for more than 30 min \n\n Patients aged between 18 to 80 years. \n\n Patients who are hemodynamically stable, with a systolic BP > 90 mmHg with or without inotropic support. \n\n Patients comatose or unresponsive post-resuscitation \n\n ", - "exclusion_criteria": ": \n\n Hypotension despite fluid and/or vasopressor support \n\n Positive pregnancy test in women below 50 years \n\n Premorbid status bedbound and uncommunicative", - "brief_summary": "Controlled therapeutic hypothermia is a method of preserving neurological function post-resuscitation.It has been associated with improved functional recovery and reduced histological deficits in animal models of cardiac arrest.", - "NCTID": "NCT00827957" - } - ], - "1": [ - { - "brief_title": "Femoral Arterial Access With Ultrasound Trial", - "phase": "", - "drugs": "['Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine)']", - "drugs_list": [ - "Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine)" - ], - "diseases": "['Vascular Access Complications', 'Cardiac Catheterization', 'Peripheral Vascular Disease']", - "diseases_list": [ - "Vascular Access Complications", - "Cardiac Catheterization", - "Peripheral Vascular Disease" - ], - "enrollment": "1014.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults age 18 and over \n\n Patients undergoing left heart catheterization or peripheral arterial angiography from the retrograde femoral approach \n\n Willingness and ability to sign consent form \n\n Scheduled to have procedure performed by operator trained in the ultrasound technique \n\n ", - "exclusion_criteria": ": \n\n Access from a site other than the common femoral artery \n\n Nonpalpable femoral pulses \n\n Creatinine > 3.0 mg/dl, unless already on dialysis \n\n Prisoners \n\n Pregnant women \n\n Unable or refusal to sign consent form \n\n Patients undergoing emergent cardiac catheterization for ST segment elevation myocardial infarction or unstable acute coronary syndrome \n\n Equipment unavailable", - "brief_summary": "This study is designed to evaluate the routine use of vascular ultrasound as an aid for proper placement of a femoral arterial sheath during cardiac catheterization and peripheral arterial angiography.", - "NCTID": "NCT00667381" - }, - { - "brief_title": "Plug Arterial Closure System (PACS, 7F)", - "phase": "Phase 2", - "drugs": "['Vascular access site closure (7F Ensure)']", - "drugs_list": [ - "Vascular access site closure (7F Ensure)" - ], - "diseases": "['Angioplasty, Transluminal, Percutaneous Coronary', 'Coronary Arteriosclerosis']", - "diseases_list": [ - "Angioplasty", - "Transluminal", - "Percutaneous Coronary", - "Coronary Arteriosclerosis" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Scheduled for a coronary diagnostic or interventional procedure \n\n Able to undergo emergent vascular surgery if a complication requires it \n\n 7F arterial puncture located in the common femoral artery \n\n Femoral artery has a lumen diameter of at least 5 mm \n\n ", - "exclusion_criteria": ": \n\n Arterial puncture in the femoral artery of both legs \n\n Prior target artery closure with any vascular closure device, or closure with manual compression within 30 days prior to catheterization \n\n Patients who bruise or bleed easily or with a history of significant bleeding or platelet disorders \n\n Acute ST-elevation myocardial infarction within 48 hours prior to catheterization \n\n Uncontrolled hypertension at time of vessel closure \n\n Elevated Activated Clotting Time at time of vessel closure \n\n Ineligible for in-catheterization lab introducer sheath removal \n\n Concurrent participation in another investigational device or drug trial \n\n Thrombolytic therapy, bivalirudin, other thrombin-specific anticoagulants, or low molecular weight heparin within 24 hours prior to catheterization \n\n Preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the vessel access site prior to femoral artery closure \n\n Prior femoral vascular surgery or vascular graft in region of access site \n\n Femoral artery is tortuous or requires an introducer sheath longer than 11 cm \n\n Fluoroscopically visible calcium, atherosclerotic disease, or stent within 1 cm of the puncture site that would interfere with the operation of the experimental device \n\n Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture \n\n Antegrade vascular puncture \n\n Body Mass Index over 40 kg/m2 \n\n Symptomatic leg ischemia in the target limb including severe claudication or weak/absent pulse \n\n Femoral artery diameter stenosis exceeding 50% \n\n Pre-existing severe non-cardiac systemic disease or terminal illness \n\n Planned arterial access at the same access site within 30 days of catheterization \n\n Extended hospitalization (e.g. CABG surgery) \n\n Pre-existing systemic or cutaneous infection \n\n Prior use of an intra-aortic balloon pump through the arterial access site \n\n Cardiogenic shock during or immediately following the catheterization \n\n Patient is unable to ambulate at baseline \n\n Patient is known or suspected to be pregnant or is lactating \n\n Patient is unavailable for follow-up \n\n Any angiographic or clinical evidence that the physician feels would place the patient at increased risk with the use of the experimental device", - "brief_summary": "The purpose of this study is to assess the safety and feasibility of the 7F Ensure Medical Vascular Closure Devices to facilitate hemostasis in patients undergoing diagnostic or interventional coronary procedures using a standard 7F introducer sheath.", - "NCTID": "NCT00533156" - }, - { - "brief_title": "Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose Design 9 System", - "phase": "Phase 1; Phase 2", - "drugs": "['closure device']", - "drugs_list": [ - "closure device" - ], - "diseases": "['Coagulation', 'Therapeutic Uses', 'Pharmacologic Actions']", - "diseases_list": [ - "Coagulation", - "Therapeutic Uses", - "Pharmacologic Actions" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n patient/legal representative provides written informed consent \n\n Patient is scheduled for a coronary or peripheral diagnostic or interventional procedure \n\n Target vessel has a lumen diameter \u2265 6 mm \n\n Patient must be willing to comply with follow-up requirements \n\n Patient has a 5-7F arterial puncture located in the common femoral artery \n\n ", - "exclusion_criteria": ": \n\n Arterial puncture in the femoral artery of both legs \n\n Manual compression has been preformed on the ipsilateral arterial site within the previous 6 weeks \n\n Any closure system has been used on the ipsilateral arterial site within the previous 180 days \n\n Any reentry of the ipsilateral site is planned within the next 6 weeks \n\n History of surgical repair of blood vessels of the ipsilateral arterial site \n\n Patient is unable to ambulate at baseline \n\n Significant bleeding diathesis or platelet dysfunction \n\n Thrombocytopenia (Plt count \u2264 100,000) \n\n Anemia (Hgb \u2264 10mg/dl and/or Hct \u2264 30mg/dl) \n\n Hemophilia \n\n Von Willebrands disease \n\n Thrombophilia (i.e. factor 5 deficiency or other) \n\n ST-elevation myocardial infarction \u2264 48 hours prior to the cardiac or peripheral catheterization procedure \n\n Pre-existing severe non-cardiac systemic disease or pre-existing terminal illness \n\n Pre-existing systemic or cutaneous infection \n\n Receiving warfarin therapy within the last 14 days. \n\n INR results > 1.2 on day of procedure for any patient with a history of warfarin therapy \n\n Thrombolytic therapy (e.g. streptokinase, urokinase, t-PA) \u2264 24 hours prior to the cardiac or peripheral catheterization procedure \n\n Concurrent participation in another investigational device or drug trial \n\n Angiomax (bivalirudin) or other thrombin-specific anticoagulants or low molecular weight heparin \u2264 24 hours prior to the cardiac or peripheral catheterization procedure \n\n Planned arterial access at the same access site \u2264 30 days following the femoral artery closure procedure \n\n Evidence of a preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to start of femoral artery closure procedure \n\n Prior femoral vascular surgery or vascular graft in region of access site or contralateral common femoral artery \n\n Symptomatic leg ischemia in the target vessel limb including severe claudication or weak/absent pulse \n\n Absent of pedal pulse on ipsilateral side \n\n Pre-existing autoimmune disease \n\n BMI > 40 kg/m2 \n\n The targeted femoral artery is tortuous or requires an introducer sheath length > 11 cm \n\n Fluoroscopically visible calcium, atherosclerotic disease, or stent \u2264 1 cm of the puncture site that would interfere with the placement of the VCD's plug \n\n Suspected bacterial contamination of access site \n\n Puncture through a vascular graft \n\n Double wall puncture \n\n Antegrade puncture \n\n Palpable Hematoma \n\n Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture \n\n Any Arterial and/or Venous access on the ipsilateral or contralateral groin other than target study access site \n\n Patient is not cooperative \n\n Intra-procedural therapeutic thrombolysis is preformed \n\n Uncontrolled hypertension at time of sheath removal (blood pressure \u2265 170 mmHg systolic and/or \u2265 100mmHg diastolic) \n\n Peripheral vascular disease on the ipsilateral arterial vessel (\u2265 50% stenosis) or aneurismal disease of this vessel. \n\n Sheaths has been changed during the procedure \n\n Heparinized patients with elevated pre-closure ACT level\u2265 300 seconds \n\n Patient has known allergy to any materials used in the VCD \n\n Patient is known to require an extended hospitalization (e.g. patient is undergoing CABG surgery) \n\n Prior or recent use of an intra-aortic balloon pump through the arterial access site \n\n Cardiogenic shock (hemodynamic instability requiring intravenous medications or mechanical support) experienced during or immediately post-catheterization \n\n Patient is known or suspected to be pregnant, or is lactating \n\n Patient has known allergy to contrast medium \n\n Any angiographic or clinical evidence that the investigator feels would place the patient at increased risk with the use of the VCD \n\n Required simultaneous ipsilateral or contralateral venous puncture", - "brief_summary": "The QuickClose Design 9 is a prospective, non randomized study, to evaluate the safety and efficacy of the QuickClose design 9 closure device.~patient undergoing a diagnostic or therapeutic angiogram procedure will be treated with the QuickClose Design 9. Patients will be monitored until 30 days after the procedure.", - "NCTID": "NCT01121510" - }, - { - "brief_title": "RISE: A Clinical Evaluation of the StarClose\u2122 Vascular Closure System", - "phase": "", - "drugs": "['Vessel Closure (StarClose\u2122)']", - "drugs_list": [ - "Vessel Closure (StarClose\u2122)" - ], - "diseases": "['Peripheral Vascular Disease', 'Cardiovascular Disease']", - "diseases_list": [ - "Peripheral Vascular Disease", - "Cardiovascular Disease" - ], - "enrollment": "165.0", - "inclusion_criteria": "Inclusion: \n\n Subject must be 18-85. \n\n Subject must be an acceptable candidate for an elective,non-emergent diagnostic procedure performed percutaneously via the common femoral artery through either a 5F or 6F procedural sheath. \n\n Subject is an acceptable candidate for emergent vascular surgery. \n\n Subject agrees to follow-up evaluations to assess for complications related to femoral access site. \n\n If among the 50 ultrasound sub-study Subjects enrolled,Subject agrees to have an ultrasound of femoral artery performed post-procedure during the 30 \u00b1 7 days follow-up visit. \n\n Subject or legal representative has been informed of the nature of the study and agrees to provisions and has provided written informed consent as approved by the Institutional Review Board of respective clinical site. \n\n Exclusion: \n\n History of bleeding diathesis or coagulopathy including hemophilia, von Willebrand's disease, and/or a current, known platelet count <100,000 cells/mm3, or baseline INR > 1.7. \n\n Body Mass Index (BMI) \u00b3 35 kg/m2. \n\n Presence of significant anemia (Hgb < 10 g/dL, Hct < 30%). \n\n Advanced Subject refusal of blood transfusions, should transfusion become necessary. \n\n Participation in another trial of an investigational drug or device that has not yet completed follow-up requirements. \n\n Pregnant or lactating female. \n\n Clinically severe peripheral vascular disease in the ipsilateral limb, defined as severe claudication (walking < 100 feet), weak or absent pulses, or lower extremity vascular graft. \n\n History of ipsilateral femoral arterial puncture within previous three months or history of vascular closure device deployment in ipsilateral femoral artery at any time. \n\n Subject has unilateral or bilateral lower extremity amputation(s). \n\n Subject is unable to routinely walk at least 20 feet without assistance. \n\n Subject has an active systemic or cutaneous infection or inflammation. \n\n Subject has a pre-existing severe non-cardiac systemic disease or illness with a life expectancy of < 30 days. \n\n Subject has already participated in this Study. \n\n Subject has known allergy to nitinol. \n\n Access Site Exclusion-(*Evaluated via Limited Femoral Angiogram) \n\n Pseudoaneurysm or AV fistula present in ipsilateral femoral artery prior to arterial closure.* \n\n Puncture distal to the common femoral artery bifurcation or above the inguinal ligament which is typically defined by the inferior border of the inferior epigastric artery on sheath angiogram or the upper third of the femoral head by plain fluoroscopy.* \n\n The arterial lumen diameter at the arteriotomy site is < 5mm by visual estimate.* \n\n Angiographic evidence of calcified lesions at the arteriotomy site.* \n\n Difficulty inserting the introducer sheath at the start of the catheterization procedure due to vessel scarring or tortuosity, or anterior/posterior wall femoral artery punctures or greater than 2 ipsilateral arterial puncture attempts at the time of the percutaneous procedure. \n\n Known iliac or femoral stenosis >50% or previous bypass surgery or stent placement in the vicinity of the puncture site. \n\n Planned percutaneous procedure (diagnostic or intervention) in ipsilateral femoral artery prior to the 30-day follow-up evaluation. \n\n Subject has intra-procedural bleeding around the access site. \n\n Presence or previous use of an intra-aortic balloon pump through the existing arterial puncture site. \n\n Procedural Exclusion: \n\n Low molecular weight heparin administration within 8 hours of enrollment. \n\n For cases where anticoagulants are used, ACT level > 350 seconds at time of enrollment. \n\n Subject is determined to require treatment that will extend hospitalization (e.g. ---Subject is undergoing CABG surgery or staged PTCA). \n\n Persistent hypertension (SBP >180 or DBP >110 mm Hg) unresponsive to medical -therapy at time of enrollment. \n\n Placement of an ipsilateral femoral venous sheath during procedure. \n\n Presence of clinically significant hematoma (> 6 cm) in ipsilateral femoral artery prior to arterial closure. \n\n Placement of introducer sheath < 5F or > 6F during procedure.", - "exclusion_criteria": "", - "brief_summary": "To evaluate early ambulation in patients who receive the StarClose\u2122 VCS post-percutaneous diagnostic procedure.", - "NCTID": "NCT00736086" - }, - { - "brief_title": "Clinical Investigation for Safety and Efficacy Study of CELT ACD (Arterial ClosureDevice)", - "phase": "", - "drugs": "['CELT ACD']", - "drugs_list": [ - "CELT ACD" - ], - "diseases": "['Cardiac Disease', 'Coronary Artery Disease']", - "diseases_list": [ - "Cardiac Disease", - "Coronary Artery Disease" - ], - "enrollment": "241.0", - "inclusion_criteria": "inclusion criteria: \n\n Over 18 years of age. \n\n Each patient, or his or her guardian or legal representative, is willing to give informed consent. \n\n Clinically indicated for an intra-arterial procedure involving access through the common femoral artery and conducted through an access sheath size of between 6F and 7F inclusive. \n\n ", - "exclusion_criteria": ": \n\n Patients with known allergy to any of the materials used in the device. \n\n Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than one year. \n\n Evidence of systemic bacterial or cutaneous infection, including groin infection. \n\n Patients suffering with definitive or potential coagulopathy or platelet count <100,000./\u00b5l \n\n Use of systemic thrombolytic agents within 24 hours prior to or during the catheterization procedure which cause the concentration of fibrinogen to be < 100 mg/dl or if post-thrombolytic fibrinogen (in case of thrombolysis within 24 hours or intra-procedural) cannot be measured. \n\n Patients in whom an introducer sheath smaller than 6F or greater than 7F have been used. \n\n Currently participating in another investigational device or drug study. \n\n Patients with severe claudication, iliac or femoral artery diameter stenosis greater than 50%, or previous bypass surgery or stent placement in the vicinity of the access site. \n\n If puncture site is via a vascular graft. \n\n If a palpable haematoma is observed during the procedure. \n\n Patients in whom there is any indication that puncture has been made in the profunda femorals artery or superficial femoral artery, or adjacent to the bifurcation. \n\n Patients with a common femoral artery lumen diameter of less than 5 mm. \n\n Patients that have any amputation from an access site limb. \n\n Patients that have undergone a percutaneous procedure using a vascular closure device for hemostasis within the previous 30 days or using manual/mechanical pressure for hemostasis within the prior 30 days in the same leg. \n\n Patients with a systolic blood pressure reading below 90 mmHg. \n\n Patients with an active haematoma, arteriovenous fistula, or pseudoaneurysm. \n\n Patients with a very superficial artery where the depth from skin to the artery surface at the access site is less than 4 mm. \n\n Morbidly obese patients (Body Mass Index >35kg/m2). \n\n Patients with a stent less than or equal to 1 cm of the puncture site that would interfere with placement of the device implant. \n\n Patient is know or suspected to be pregnant, or is lactating. \n\n Patients in whom there has been an antegrade puncture. \n\n Patients in whom there has been difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial wall puncture. \n\n Patients who have undergone prior or recent use of an intra-aortic balloon pump through the arterial access site. \n\n Patients with uncontrolled hypertension (BP greater than or equal to 180/110mmHg) at time of vascular closure \n\n Patients with acute ST-elevation myocardial infarction less than or equal to 48hours before catheterization procedure. \n\n Patients with cardiogenic shock (hemodynamic instability requiring intravenous medication or mechanical support) experienced during or immediately post-catheterization. \n\n Patients who are unable to ambulate at baseline. \n\n Patients known to require an extended hospitalization (e.g. patient is undergoing cardiac surgery). \n\n Patient has already participated in the trial. \n\n Patient is unavailable for follow up. \n\n -", - "brief_summary": "The objective of the CELT ACD\u00ae Vascular Closure Device study is to evaluate the safety and effectiveness of the CELT ACD\u00ae device to achieve hemostasis of the common femoral artery access site in patients on anticoagulation who are undergoing a percutaneous intervention (PCI) procedure using a 6F sheath.", - "NCTID": "NCT01600482" - }, - { - "brief_title": "Use of Local Anesthetic (0.25% Bupivacaine) for Pain Control in Pediatric Cardiac Catheterization", - "phase": "Phase 2", - "drugs": "['Standard of Care', 'Standard of Care plus bupivacaine']", - "drugs_list": [ - "Standard of Care", - "Standard of Care plus bupivacaine" - ], - "diseases": "['Pain']", - "diseases_list": [ - "Pain" - ], - "enrollment": "140.0", - "inclusion_criteria": "inclusion criteria: \n\n Ages 7-18 years \n\n Scheduled for cardiac catheterization through the femoral artery and/or vein under general anesthetic \n\n Ability to speak and understand English \n\n No apparent cognitive impairments \n\n ", - "exclusion_criteria": ": \n\n Known allergies to bupivacaine \n\n Impaired renal function \n\n Impaired hepatic function", - "brief_summary": "In the Cardiac Diagnostic and Interventional Unit (CDIU) at the Hospital for Sick Children (SickKids), minimally invasive procedures are performed to diagnose and treat a variety of congenital heart defects. Procedures are performed under general anesthetic and involve inserting a catheter through the skin and into the femoral vein or artery in the groin. In addition, the use of local anesthetic as a pain control regimen just prior to the removal of femoral artery or vein sheaths is used by some but not all cardiac interventionalists. Local anesthetic is infiltrated near the sheath insertion site, at the end of the procedure while the child is under general anesthetic, with the goal of decreasing pain at the insertion site and promoting comfort in the post-operative period. The use of local anesthetic depends on the choice of the individual practitioner and is not currently a routine practice for all patients.~The investigators proposed research seeks to investigate whether the use of subcutaneous bupivacaine reduces pain levels in the post-operative period in children having cardiac catheterization procedures.", - "NCTID": "NCT01133119" - }, - { - "brief_title": "Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery", - "phase": "", - "drugs": "['standard gauze dressing', 'Prevena Incision Management system']", - "drugs_list": [ - "standard gauze dressing", - "Prevena Incision Management system" - ], - "diseases": "['Peripheral Artery Disease', 'Critical Limb Ischemia', 'Claudication']", - "diseases_list": [ - "Peripheral Artery Disease", - "Critical Limb Ischemia", - "Claudication" - ], - "enrollment": "242.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 18 \n\n Patient undergoing vascular surgery that would include a groin incision as a standard part of the operation. Infrainguinal bypass including femoral popliteal/tibial/pedal artery bypass with autogenous or prosthetic conduit. \n\n femoral endarterectomy with or without patch angioplasty involving the common femoral artery and/or profunda and/or proximal superficial artery. The index groin may have undergone prior procedures (may be inflow or outflow for existing grafts), but the patient must have fully healed from the prior operation. May include patients with concomitant proximal and/or distal peripheral vascular intervention. The patch may be autogenous venous or arterial or prosthetic material such as bovine pericardium, dacron or polytetrafluoroethylene (PTFE). Bilateral femoral endarterectomies are eligible for enrollment. The right and left groin incision would be randomized to the same dressing which is consistent with routine clinical practice. \n\n Willing to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent. \n\n ", - "exclusion_criteria": ": \n\n Any groin incision on index leg within 12 weeks prior to treatment initiation. \n\n Infrainguinal bypass without a groin incision including popliteal-tibial or pedal bypass. \n\n Supra inguinal procedures such as open or endovascular abdominal aortic aneurysm repair or aorto-femoral/bi-femoral bypass for occlusive disease. \n\n Undergoing current chemotherapy or radiation therapy. \n\n Pregnancy or lactation. \n\n Inability or refusal to provide informed consent. \n\n Patients who received an investigational drug for peripheral arterial disease within 4 weeks of screening or who participated in another non-observational clinical trial in the prior 30 days. \n\n Surgical incision in the groin without primary closure including previously open or infected wounds. \n\n Sensitivity or allergy to silver. \n\n Prior enrollment in this randomized controlled trial.", - "brief_summary": "The purpose of this study is to evaluate the effectiveness of negative pressure incision management system (Prevena\u2122 Incision Management System (PIMS) or ActiVAC\u00ae with the Prevena\u2122 Dressings (Peel and Place\u2122 or Customizable\u2122), KCI) in the prevention of wound complications including surgical site infection (SSI) and non-infectious complications in patients undergoing vascular surgery with groin incisions.", - "NCTID": "NCT02389023" - }, - { - "brief_title": "Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis", - "phase": "", - "drugs": "['GamCath\u00ae', 'Arteriovenous fistula creation', 'GamCath\u00ae', 'Arteriovenous fistula creation']", - "drugs_list": [ - "GamCath\u00ae", - "Arteriovenous fistula creation", - "GamCath\u00ae", - "Arteriovenous fistula creation" - ], - "diseases": "['Renal Failure Chronic Requiring Hemodialysis', 'Central Venous Catheterization', 'Inadequate Hemodialysis Blood Flow', 'Venous Stenosis', 'Venous Thrombosis', 'Infection Due to Central Venous Catheter', 'Central Venous Catheter Thrombosis']", - "diseases_list": [ - "Renal Failure Chronic Requiring Hemodialysis", - "Central Venous Catheterization", - "Inadequate Hemodialysis Blood Flow", - "Venous Stenosis", - "Venous Thrombosis", - "Infection Due to Central Venous Catheter", - "Central Venous Catheter Thrombosis" - ], - "enrollment": "1400.0", - "inclusion_criteria": "inclusion criteria: \n\n Chronic renal failure requiring hemodialysis. \n\n No medical history of central vena catheterization. \n\n Maintenance hemodialysis after central vena catheterization. \n\n Signed informed consent. \n\n ", - "exclusion_criteria": ": \n\n Had been performed central venous puncture or catheterization before. \n\n Can not use heparin. \n\n Refused to sign the informed consent. \n\n Advanced cancer patients. \n\n With or will take arteriovenous fistula surgery in right arm. \n\n Other inappropriate situation", - "brief_summary": "The duration and adverse events of non-cuffed catheter in patients with hemodialysis will be investigated by multicenter prospective cohort. Totally, 1,400 patients with chronic renal failure requiring hemodialysis will be enrolled. 900 patients will be given right internal jugular catheterization, and the other 500 patients unsuitable for right internal jugular catheterization will receive femoral catheterizations. Every patient will be followed-up for six months. During following-up period, the duration time and adverse events of non-cuffed catheter will be recorded in details, including inadequate hemodialysis blood flow, venous stenosis, venous thrombosis, infection, catheter thrombosis and so on. The central vein will be evaluated by CT Angiography to identify its stenosis at last visit after 6 months. This multicentre trial will provide evidence to develop guideline for duration time of using non-cuffed catheter.", - "NCTID": "NCT02264964" - }, - { - "brief_title": "Prospective Registry on Vascular Access in Interventions in Lazio Region", - "phase": "Phase 4", - "drugs": "['Any percutaneous cardiovascular procedure']", - "drugs_list": [ - "Any percutaneous cardiovascular procedure" - ], - "diseases": "['Postoperative Hemorrhages']", - "diseases_list": [ - "Postoperative Hemorrhages" - ], - "enrollment": "1052.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients undergoing any percutaneous cardiovascular procedure \n\n ", - "exclusion_criteria": ": \n\n Patients already enrolled in other clinical trials", - "brief_summary": "Previous randomised studies showed that radial artery catheterisation for percutaneous cardiovascular procedures has a superior safety profile than femoral access, however the confirmation of these benefits in the real world by a large, specific, observational study is still lacking.~We endeavoured to assess the access site-related outcomes of any percutaneous cardiovascular procedure by designing a prospective registry monitoring a consecutive sample of patients in a short period of time at nine Roman hospitals reflecting the contemporary state of health care.", - "NCTID": "NCT00674778" - }, - { - "brief_title": "Safety and Performance Study of Large Hole Vascular Closure Device", - "phase": "", - "drugs": "['VIVASURE CLOSURE DEVICE\u2122']", - "drugs_list": [ - "VIVASURE CLOSURE DEVICE\u2122" - ], - "diseases": "['Percutaneous Common Femoral Artery Arteriotomy Closure']", - "diseases_list": [ - "Percutaneous Common Femoral Artery Arteriotomy Closure" - ], - "enrollment": "65.0", - "inclusion_criteria": "inclusion criteria: \n\n Over 18 years of age \n\n Each patient, or his or her guardian or legal representative, is willing to give informed consent \n\n Clinically indicated for an endovascular procedure involving access through the femoral artery, with an access puncture of 18 - 24 French (F) \n\n Females who are not pregnant or lactating, and not planning to become pregnant in \u2264 12 months \n\n ", - "exclusion_criteria": ": \n\n Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than one year \n\n Evidence of systemic bacterial or cutaneous infection \n\n Evidence of MRSA (Methicillin-resistant Staphylococcus aureus) and/or VRE (vancomycin-resistant Enterococci) colonisation \n\n Arterial access other than the common femoral artery \n\n Patients suffering with definitive or potential coagulopathy or platelet count less than 100,000/\u03bcl \n\n Patient with a haematocrit of less than 32 % \n\n A measured activated clotting time (ACT) of greater than 350 seconds immediately prior to sheath removal \n\n If patients are expected to be continuously treated with anticoagulation therapy post-procedure such that their ACT reading is expected to be elevated above 350 seconds for more than 24 hours after the procedure \n\n Evidence of arterial diameter stenosis greater than 20 % within 20 mm of the arteriotomy \n\n Circumferential calcification within 20 mm of the arteriotomy \n\n Use of systemic thrombolytic agents within 24 hours prior to or during the catheterisation procedure which cause the concentration of fibrinogen to be less than 100 mg/dl \n\n Patients in which the arteriotomy is less than 18 F or greater than 24 F \n\n Known allergy to any of the materials used in the device \n\n Currently enrolled in any other investigational clinical study, whereby the primary endpoint has not yet been achieved \n\n Patients judged unsuitable for surgical repair of the access site \n\n If puncture site is via a vascular graft \n\n If there is any indication that the puncture has been made in the profunda femoris or located less than 10 mm above the profunda femoris \n\n Patients with a common femoral artery lumen diameter of less than 7 mm \n\n Patients that have a lower extremity amputation from the ipsilateral or contralateral limb \n\n Patients that have undergone a percutaneous procedure using a non-absorbable vascular closure device (excluding suture mediated) for haemostasis in the ipsilateral leg \n\n Patients that have undergone a percutaneous procedure greater than 8 F in the ipsilateral leg, within the previous 90 days \n\n Patients that have undergone a percutaneous procedure of 8 F or less using an absorbable intravascular closure device for haemostasis, in the ipsilateral leg, within the previous 90 days \n\n Patients that have undergone a percutaneous procedure of 8 F or less using a suture mediated closure device for haemostasis, in the ipsilateral leg, within the previous 30 days \n\n Patients that have undergone a percutaneous procedure of 8 F or less using manual/mechanical pressure for haemostasis in the ipsilateral leg, within the previous 30 days \n\n Patients with an acute haematoma of any size, arteriovenous fistula or Pseudoaneurysm at the access site \n\n Significant blood loss/transfusion during interventional procedure or within 20 days of procedure requiring transfusion of greater than 4 units of blood \n\n Angiographic evidence of arterial laceration, dissection or stenosis within the external iliac or femoral artery before the use of the VCD \n\n Severe claudication, stenosis of the iliac artery > 50% or previous bypass surgery/stent placement in the region of the vascular access", - "brief_summary": "The purpose of this Clinical Investigation is to validate that the clinical use of the VIVASURE CLOSURE DEVICE\u2122 is safe for the operator, patient and third parties, and to confirm its performance to percutaneously close femoral arterial puncture sites in the range of 18-24 F, post endovascular procedures.~This is a non-inferiority study based on safety. Safety will be assessed by incidence and severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE\u2122 up to 3 months from implantation is no worse than those associated with cut-down and sutured close.", - "NCTID": "NCT02241642" - }, - { - "brief_title": "Safety and Performance Study of Large Hole Vascular Closure Device", - "phase": "", - "drugs": "['VIVASURE CLOSURE DEVICE\u2122']", - "drugs_list": [ - "VIVASURE CLOSURE DEVICE\u2122" - ], - "diseases": "['Percutaneous Closure of Arteriotomy in Common Femoral Artery']", - "diseases_list": [ - "Percutaneous Closure of Arteriotomy in Common Femoral Artery" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria: \n\n Over 18 years of age. \n\n Each patient, or his or her guardian or legal representative, is willing to give informed consent. \n\n Clinically indicated for an endovascular procedure involving access through the femoral artery, with an access puncture of 18 - 24 F. \n\n Females who are not pregnant or lactating, and not planning to become pregnant \u2264 12 months. A pregnancy test may be performed to confirm this. \n\n ", - "exclusion_criteria": ": \n\n There will be no exclusion of patients from this trial in respect of race, co-existent disease or concomitant therapy, with the exception of those listed below. \n\n Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than one year. \n\n Evidence of systemic bacterial or cutaneous infection, including groin infection. \n\n Evidence of MRSA (Methicillin-resistant Staphylococcus aureus) and/or VRE (vancomycin-resistant Enterococci) colonisation. \n\n With arterial access other than the common femoral artery.* \n\n Patients suffering with definitive or potential coagulopathy or platelet count less than 100,000/\u00b5l. \n\n Patient with a haematocrit of less than 32 %. \n\n A measured activated clotting time (ACT) of greater than 350 seconds immediately prior to sheath removal.* \n\n If patients are expected to be continuously treated with anticoagulation therapy post-procedure such that their ACT reading is expected to be elevated above 350 seconds for more than 24 hours after the procedure. \n\n Evidence of arterial diameter stenosis greater than 20 % within 20 mm of the arteriotomy.* \n\n Circumferential calcification within 20 mm of the arteriotomy.* \n\n Use of systemic thrombolytic agents within 24 hours prior to or during the catheterisation procedure which cause the concentration of fibrinogen to be less than 100 mg/dl. \n\n Patients in which the arteriotomy is less than 18 F or greater than 24 F.* \n\n Known allergy to any of the materials used in the device (Refer to Instructions for Use). \n\n Currently enrolled in any other investigational clinical study, where the primary endpoint has not yet been achieved. \n\n Patients judged unsuitable for surgical repair of the access site. \n\n If puncture site is via a vascular graft. \n\n If there is any indication that the puncture has been made in the profunda femoris or located less than 10 mm above the profunda femoris.* \n\n Patients with a common femoral artery lumen diameter of less than 7 mm. \n\n Patients that have a lower extremity amputation from an access site limb. \n\n Patients that have undergone a percutaneous procedure using a non-absorbable vascular closure device (excluding suture mediated) for haemostasis in the ipsilateral leg. \n\n Patients that have undergone a percutaneous procedure greater than 8 F in the ipsilateral leg, within the previous 90 days. \n\n Patients that have undergone a percutaneous procedure of 8 F or less using an absorbable intravascular closure device for haemostasis, in the ipsilateral leg, within the previous 90 days. \n\n Patients that have undergone a percutaneous procedure of 8 F or less using a suture mediated closure device for haemostasis, in the ipsilateral leg, within the previous 30 days. \n\n Patients that have undergone a percutaneous procedure of 8 F or less using manual/mechanical pressure for haemostasis in the ipsilateral leg, within the previous 30 days. \n\n Patients with an acute haematoma of any size, arteriovenous fistula or Pseudoaneurysm at the access site.* \n\n Significant blood loss/transfusion during interventional procedure or within 20 days prior to procedure requiring transfusion of greater than 4 units of blood.* \n\n Angiographic evidence of arterial laceration, dissection or stenosis within the external iliac or femoral artery before the use of the VCD.* \n\n May not be known until after the patient has given informed consent and the procedure has started.", - "brief_summary": "The purpose of this Clinical Investigation is to gather feasibility data on the clinical use of the VIVASURE CLOSURE DEVICE\u2122 in relation to safety, and to confirm its performance to percutaneously close femoral arterial puncture sites in the range of 18-24 F, post endovascular procedures.", - "NCTID": "NCT01943344" - }, - { - "brief_title": "Randomized Comparison of Radiological Exposure With TRIPTable\u00ae in Patients With Acute Coronary Syndromes", - "phase": "", - "drugs": "['TripTable', 'Radial', 'Femoral']", - "drugs_list": [ - "TripTable", - "Radial", - "Femoral" - ], - "diseases": "['Acute Coronary Syndromes', 'Angioplasty, Transluminal, Percutaneous Coronary']", - "diseases_list": [ - "Acute Coronary Syndromes", - "Angioplasty", - "Transluminal", - "Percutaneous Coronary" - ], - "enrollment": "99.0", - "inclusion_criteria": "inclusion criteria: \n\n Unstable angina with an indication for invasive stratification \n\n Acute coronary syndrome without ST-segment elevation \n\n Acute coronary syndrome with ST-segment elevation \n\n Patient informed of the nature of the study and have signed the Informed Consent \n\n Patient suitable for coronary angiography and / or percutaneous coronary intervention either by radial access as the femoral \n\n ", - "exclusion_criteria": ": \n\n Below 18 years of age \n\n Pregnancy \n\n Chronic use of vitamin K antagonists, or direct thrombin inhibitors or antagonists of factor Xa, \n\n Active bleeding or high risk of bleeding (severe hepatic insufficiency, active peptic ulcer disease, creatinine clearance <30 mL / min, platelet count <100,000 mm3); \n\n Uncontrolled hypertension; \n\n Cardiogenic shock; \n\n Previous coronary artery bypass graft surgery with the use of \u2265 1 graft \n\n Patients not candidates for the use of any of the specified vascular access \n\n Concomitant severe disease with life expectancy less than 12 months life; \n\n Medical, geographical, or social conditions that impede study participation \n\n Refusal or inability to understand and sign the informed consent form.", - "brief_summary": "Excessive radiation received by the operator has been described as a possible drawback of the radial catheterization technique when compared with the femoral access.~The study hypothesis is that the use of radial access device dedicated radioprotective TRIPTable \u00ae (Transradial Intervention Table Protection) is not inferior to standard femoral technique and superior to standard radial technique as radioprotection strategy to the operator in patients with acute coronary syndromes acute and submitted to cardiac catheterization.", - "NCTID": "NCT02200783" - } - ], - "2": [ - { - "brief_title": "Preconditioning Shields Against Vascular Events in Surgery", - "phase": "", - "drugs": "['Remote ischaemic preconditioning']", - "drugs_list": [ - "Remote ischaemic preconditioning" - ], - "diseases": "['Abdominal Aortic Aneurysm', 'Carotid Atherosclerosis', 'Critical Lower Limb Ischaemia']", - "diseases_list": [ - "Abdominal Aortic Aneurysm", - "Carotid Atherosclerosis", - "Critical Lower Limb Ischaemia" - ], - "enrollment": "400.0", - "inclusion_criteria": "inclusion criteria: \n\n Age greater than 18 years \n\n Patient willing to give full informed consent for participation \n\n Patients undergoing elective carotid endarterectomy or \n\n Patients undergoing open abdominal aortic aneurysm repair or \n\n Patients undergoing endovascular abdominal aneurysm repair or \n\n Patients undergoing surgical lower limb revascularisation (suprainguinal or infrainguinal) \n\n ", - "exclusion_criteria": ": \n\n Pregnancy \n\n Significant upper limb peripheral arterial disease \n\n Previous history of upper limb deep vein thrombosis \n\n Patients on glibenclamide or nicorandil (these medications may interfere with RIPC) Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2 \n\n Patients with a known history of myocarditis, pericarditis or amyloidosis \n\n Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2. \n\n Patients with severe hepatic disease defined as an international normalised ratio >2 in the absence of systemic anticoagulation \n\n Patients with severe respiratory disease (for the trial, defined as patients requiring home oxygen therapy) \n\n Patients previously enrolled in the trial representing for a further procedure \n\n Patients with previous axillary surgery", - "brief_summary": "Major vascular surgery involves operations to repair swollen blood vessels, clear debris from blocked arteries or bypass blocked blood vessels. Patients with these problems are a high-risk surgical group as they have generalized blood vessel disease. These puts them at risk of major complications around the time of surgery such as heart attacks , strokes and death. The mortality following repair of a swollen main artery in the abdomen is about 1 in 20. This contrasts poorly with the 1 per 100 risk of death following a heart bypass. Simple and cost-effective methods are needed to reduce the risks of major vascular surgery. Remote ischaemic preconditioning (RIPC) may be such a technique. To induce RIPC, the blood supply to muscle in the patient's arm is interrupted for about 5 minutes. It is then restored for a further five minutes. This cycle is repeated three more times. The blood supply is interrupted simply by inflating a blood pressure cuff to maximum pressure. This repeated brief interruption of the muscular blood supply sends signals to critical organs such as the brain and heart, which are rendered temporarily resistant to damage from reduced blood supply. Several small randomized clinical trials in patients undergoing different types of major vascular surgery have demonstrated a potential benefit. This large, multi-centre trial aims to determine whether RIPC can reduce complications in routine practice.", - "NCTID": "NCT02097186" - }, - { - "brief_title": "Preconditioning Shields Against Vascular Events in Surgery", - "phase": "", - "drugs": "['Remote preconditioning']", - "drugs_list": [ - "Remote preconditioning" - ], - "diseases": "['Abdominal Aortic Aneurysm', 'Carotid Atherosclerosis', 'Critical Lower Limb Ischaemia']", - "diseases_list": [ - "Abdominal Aortic Aneurysm", - "Carotid Atherosclerosis", - "Critical Lower Limb Ischaemia" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Age greater than 18 years \n\n patient willing to give full informed consent for participation \n\n Patients undergoing elective carotid endarterectomy or \n\n Patients undergoing open abdominal aortic aneurysm repair or \n\n Patients undergoing endovascular abdominal aneurysm repair or \n\n Patients undergoing surgical lower limb revascularisation (suprainguinal or infrainguinal) \n\n ", - "exclusion_criteria": ": \n\n Patients less than 18 years of age \n\n Patients who are unable or unwilling to give full informed consent \n\n Pregnancy \n\n Significant upper limb peripheral arterial disease \n\n Patients on glibenclamide or nicorandil (these medications may interfere with remote ischaemic preconditioning) \n\n Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2 \n\n Patients with a history of myocarditis, pericarditis or amyloidosis \n\n Patients undergoing Fenestrated or branched EVAR.", - "brief_summary": "Major vascular surgery involves operations to repair swollen blood vessels, clear debris from blocked arteries or bypass blocked blood vessels. Patients with these problems are a high-risk surgical group as they have generalized blood vessel disease. These puts them at risk of major complications around the time of surgery such as heart attacks , strokes and death. The mortality following repair of a swollen main artery in the abdomen is about 1 in 20. This contrasts poorly with the 1 per 100 risk of death following a heart bypass. Simple and cost-effective methods are needed to reduce the risks of major vascular surgery. Remote ischaemic preconditioning (RIPC) may be such a technique. To induce RIPC, the blood supply to muscle in the patient's arm is interrupted for about 5 minutes. It is then restored for a further five minutes. This cycle is repeated three more times. The blood supply is interrupted simply by inflating a blood pressure cuff to maximum pressure. This repeated brief interruption of the muscular blood supply sends signals to critical organs such as the brain and heart, which are rendered temporarily resistant to damage from reduced blood supply. Several small randomized clinical trials in patients undergoing different types of major vascular surgery have demonstrated a potential benefit. This large, multi-centre trial aims to determine whether RIPC can reduce complications in routine practice.", - "NCTID": "NCT01691911" - }, - { - "brief_title": "Use of Amplified Sound Signal to Identify Presence of Carotid and Femoral Stenosis", - "phase": "", - "drugs": "['AudioDoc']", - "drugs_list": [ - "AudioDoc" - ], - "diseases": "['Carotid Stenosis', 'Femoral Arterial Stenosis', 'Carotid Bruit Asymptomatic', 'Carotid Murmur']", - "diseases_list": [ - "Carotid Stenosis", - "Femoral Arterial Stenosis", - "Carotid Bruit Asymptomatic", - "Carotid Murmur" - ], - "enrollment": "18.0", - "inclusion_criteria": "inclusion criteria: \n\n age 19-90 years \n\n having clinical ultrasound evaluation of carotid or femoral artery \n\n ", - "exclusion_criteria": ": \n\n under age 19; over age 90 years", - "brief_summary": "The purpose of the study is to test a new amplified stethoscope(AudioDoc) that can detect the presence of bruit by using an acoustic signal to represent the bruit. This pilot study will address two questions: is there a detectable difference in recorded sound signal of carotid and femoral bruit when compared to sound signals captured when there is no bruit present; is the use of a visual recorded signal more accurate in identifying carotid and femoral bruit when compared to traditional auscultation with a regular stethoscope and ultrasound.", - "NCTID": "NCT01599195" - }, - { - "brief_title": "Neuromuscular Electrical Stimulation in Patients With Critical Limb Ischaemia", - "phase": "", - "drugs": "['Revitive IX']", - "drugs_list": [ - "Revitive IX" - ], - "diseases": "['Peripheral Arterial Disease', 'Critical Limb Ischaemia']", - "diseases_list": [ - "Peripheral Arterial Disease", - "Critical Limb Ischaemia" - ], - "enrollment": "4.0", - "inclusion_criteria": "inclusion criteria: \n\n Willing, able, and committed to participate in the procedures for the full length of the study. \n\n All ethnic groups, male or female above the age of 18 years. \n\n Diagnosis of non-reconstructable arterial disease and critical limb ischaemia (with a minimum of duplex ultrasound and an MDT discussion to have reached this diagnosis) \n\n Be of non-childbearing potential; OR using adequate contraception and have a negative urine pregnancy test result within 24 hours if appropriate before using the study device. \n\n Blood pressure currently under moderate control (< 160/100mmHg) \n\n History of uncomplicated cardiovascular events beyond 3 months. \n\n No current foot ulceration \n\n ", - "exclusion_criteria": ": \n\n Patients meeting any of the following criteria are to be excluded: \n\n Has an unstable condition (eg, psychiatric disorder, a recent history of substance abuse) or otherwise thought to be unreliable or incapable of complying with the study protocol. \n\n Has any metal implants \n\n Pregnant \n\n Has peripheral neuropathy \n\n Has a cardiac pacemaker or defibrillator device \n\n Has recent lower limb injury or lower back pain \n\n Has current foot ulceration or other skin ulcers \n\n Has foot deformities \n\n Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study \n\n Ankle-Brachial Pressure Index >0.9", - "brief_summary": "This study will assess the benefit of a neuromuscular electrical stimulation device in patients suffering from symptoms and effects of critical limb ischaemia.", - "NCTID": "NCT02634138" - } - ] - }, - { - "patient_id": "sigir-201411", - "patient": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", - "0": [ - { - "brief_title": "HEAVy HAT-HEAlthy Volunteers Heart to Arm Time. Haemorrhage Simulation Protocol in Healthy Volunteers", - "phase": "", - "drugs": "['LBNP Lower Bodi Negative Pressure Chamber']", - "drugs_list": [ - "LBNP Lower Bodi Negative Pressure Chamber" - ], - "diseases": "['Shock']", - "diseases_list": [ - "Shock" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n 30 healthy volunteers with no assumption of coffee or any other substance with possible action on the autonomic nervous system. \n\n ", - "exclusion_criteria": ": \n\n age < 18 yrs, \n\n pregnancy, \n\n assumption of any drugs and existence of any disease, \n\n intake of any drug/substance with action on the autonomic nervous system during the previous 24 hours.", - "brief_summary": "In prehospital settings, hypovolemic shock diagnosis is based on Advanced Trauma Life Support (ATLS) shock classification. The most often used clinical signs are heart rate (HR), arterial blood pressure (BP), respiratory rate, neurologic status, diuresis, skin colour and temperature. However, some of these signs, such as hypotension and tachycardia, lack specificity and sensitivity and do not occur early enough. Even with an early preload reduction, blood pressure can remain constant due to compensatory mechanisms, such as vasoconstriction and positive chronotropism. Tachycardia occurs earlier, but has poor specificity and sensitivity. A retrospective analysis of 25,287 trauma patients showed that among 489 patients presenting with systolic BP < 90 mmHg, only 65% had tachycardia (HR > 90 bpm), while 39% of patients with systolic BP > 120 mmHg were tachycardic, probably resulting from other stimuli influencing heart rate, such as pain, fear, circulating hormones and endogenous enkephalins. Therefore, it could be very useful to have an index that identifies initial volume variation, when physiological regulatory mechanisms are still effectively maintaining normal BP.~Pulse transit time (PTT) is the sum of pre-ejection period (PEP; the time interval between the onset of ventricular depolarization and ventricular ejection) and vascular transit time (VTT; the time it takes for the pulse wave to travel from the aortic valve to peripheral arteries). PEP and VTT variations depend on preload variation, and PTT increases with PEP, showing a linear correlation (R2 = 0.96). Chan et al. subjected 11 healthy volunteers to the head-up tilt test, and demonstrated that PEP increased and VTT decreased for increasing tilt angles from 0\u00b0 to 80\u00b0, corresponding to light-moderate bleeding. They also observed early sympathetic activation, expressed by decreases of both RR interval (RR) and VTT, dampening the PTT increase, since PTT is influenced by both continuous PEP increase and progressive VTT decrease occurring during hypovolaemia.~Here the investigators describe a new index, called indexed Heart to Arm Time (iHAT). iHAT is the mPTT/RR ratio, where mPTT is a modified PTT, measured from the onset of ventricular depolarization (the 'R' wave of the ECG trace) to the systolic peak of the photoplethysmographic pulse oxymetry (PPG) waveform. mPTT is indexed to RR interval on ECG to counteract sympathetic activation that would dampen PEP increase and enhance VTT reduction, by means of positive inotropism and peripheral vasoconstriction, respectively. iHAT therefore increases during haemorrhage because of preload reduction and the consequent PEP increase and RR interval decrease. iHAT is expressed as the time percentage of the interbeat interval (RR) it takes to the PPG waveform to travel to peripheral arteries. In this study iHAT has been calculated as the average of beat-to-beat mPTT/RR ratios over 30 heart beats (corresponding to at least 2 breathing cycles) in order to minimize the effect of spontaneous breathing on preload, and thus on PEP and PTT.~In the present study, the investigators aimed to evaluate iHAT in a simulating model of hypovolaemia by using a Lower Body Negative Pressure (LBNP) chamber. LBNP chamber simulates haemorrhage by applying negative pressure to the lower limbs, thus giving an accurate model of hypovolemia. The LBNP chamber has been used for many years for research purposes, and in 2001 Convertino suggested it is a useful device to test severe haemorrhage-related hemodynamic responses. In fact, the induced volemic sequestration is an efficient technique to study physiological behaviours in humans.~The primary endpoint was to evaluate the use of the iHAT as a predictor of hypovolaemia. The secondary endpoint was to compare the specificity and sensitivity of the iHAT index compared to commonly used indexes (BP, HR). Furthermore, the investigators aimed to assess feasibility of Transthoracic echocardiography (TTE) evaluation of Cardiac Output (CO) in a haemorrhagic model and to evaluate CO changes with respect to measured hemodynamic variables.~TTE evaluation of CO is non invasive and comparable to thermodilution, and of possible use in an emergency setting.", - "NCTID": "NCT02177188" - }, - { - "brief_title": "Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain", - "phase": "", - "drugs": "['HEART Pathway']", - "drugs_list": [ - "HEART Pathway" - ], - "diseases": "['Acute Coronary Syndrome', 'Chest Pain']", - "diseases_list": [ - "Acute Coronary Syndrome", - "Chest Pain" - ], - "enrollment": "282.0", - "inclusion_criteria": "inclusion criteria: \n\n Age greater than or equal to 21 years \n\n Chest discomfort or other symptoms consistent with possible ACS \n\n The treating physician feels the patient could be discharged home if cardiac disease was excluded \n\n ", - "exclusion_criteria": ": \n\n New ST-segment elevation in contiguous leads on any electrocardiogram (>/= 1 mV) \n\n Unstable vitals signs: symptomatic hypotension at the time of enrollment (systolic < 90 mm Hg), tachycardia (HR>120), bradycardia (HR<40), and hypoxemia (<90% pulse-oximetry on room air or normal home oxygen flow rate) \n\n Terminal diagnosis with life expectancy less than 1 year \n\n A non-cardiac medical, surgical, or psychiatric illness determined by the provider to require admission, increase risk of objective cardiac testing, or prevent immediate discharge following negative testing. \n\n Prior enrollment \n\n Incapacity or unwillingness to provide consent and comply with study procedures \n\n Non-English speaking \n\n Sub-study I & II \n\n inclusion criteria: \n\n ED attending physicians \n\n ", - "brief_summary": "Our research will examine a chest pain care strategy, called the HEART pathway, which is designed to correctly identify Emergency Department patients at high-risk for cardiovascular events, likely to benefit from further testing, and patients at very-low-risk for cardiovascular events, who may be safely discharged home. By using an individual's risk assessment to determining testing, we hope to improve the quality and efficiency of the care delivered to Emergency Department patients with chest pain. Our study will determine if the HEART pathway, which combines a clinical decision rule, the HEART score, and two serial troponin measurements, will reduce stress testing and cardiovascular imaging, decrease hospital length of stay, and reduce cost compared to usual care, while maintaining safety.", - "NCTID": "NCT01665521" - }, - { - "brief_title": "Laparoscopic Appendectomy for Chronic Right Lower Abdominal Pain", - "phase": "Phase 3", - "drugs": "['laparoscopic appendectomy or not (surgery)']", - "drugs_list": [ - "laparoscopic appendectomy or not (surgery)" - ], - "diseases": "['Chronic or Recurrent Appendicitis']", - "diseases_list": [ - "Chronic or Recurrent Appendicitis" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients were eligible if they were between 15 and 45 years of age, and if they suffered from chronic or recurrent right lower abdominal quadrant pain for more than three months. They were to experience continuous pain, or should have endured at least one pain attack in the month prior to inclusion. \n\n ", - "exclusion_criteria": ": \n\n ", - "brief_summary": "It is questionable whether elective appendectomy can effectively reduce pain in persistent or recurrent lower abdominal quadrant pain due to chronic appendicitis.~A single centre randomised double-blind sham surgery controlled clinical trial studied the effects of elective laparoscopic appendectomy on postoperative pain perception in patients with persistent or recurrent lower abdominal quadrant pain on abdominal pain at 6 months postoperatively. Secondary outcome was the relation between clinical response and the appendix' histopathology. The analysis was performed on an intention-to-treat basis. Pain scores were compared using a Fisher's exact test.", - "NCTID": "NCT00413855" - }, - { - "brief_title": "Low Level Laser Therapy to Reduce Chronic Pain", - "phase": "", - "drugs": "['Erchonia PL2000 Laser', 'Placebo laser']", - "drugs_list": [ - "Erchonia PL2000 Laser", - "Placebo laser" - ], - "diseases": "['Chronic Pain']", - "diseases_list": [ - "Chronic Pain" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Muscular-skeletal pain in the neck/shoulder region \n\n Acute and chronic pain in the neck/shoulder region \n\n Restricted range of motion in the neck/shoulder region \n\n Fibrosis or scar tissue in the neck/shoulder region \n\n Inflammation in the neck/shoulder region \n\n Altered function in the neck/shoulder region \n\n Muscle strains in the neck/shoulder region \n\n Rating of 30 or greater on the 0-100 Visual Analog Scale (VAS) pain scale \n\n 18-65 years of age \n\n ", - "exclusion_criteria": ": \n\n Severely herniated disks \n\n Pregnancy \n\n Taken pain medication within the past 12 hours", - "brief_summary": "The purpose of this study was to determine whether low level laser light directed at the neck and shoulders could be effective in the temporary reduction of chronic pain in the neck and shoulder region.", - "NCTID": "NCT00929773" - }, - { - "brief_title": "Diagnosing Pneumonia Under Low-resource Conditions", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Asthma', 'Pneumonia', 'Bronchiolitis']", - "diseases_list": [ - "Asthma", - "Pneumonia", - "Bronchiolitis" - ], - "enrollment": "502.0", - "inclusion_criteria": "inclusion criteria: \n\n All children below 5 exceeding WHO age-dependent tachypnea criteria. \n\n ", - "exclusion_criteria": ": \n\n None", - "brief_summary": "Pneumonia is the commonest cause of death in children worldwide, killing 1.5 million children under the age of 5 years, every year. This is more than the number of children dying from AIDS, malaria and tuberculosis combined. The current diagnostic and management protocols for managing serious respiratory diseases in children are 30 years old and are greatly in need of updating. The successful establishment of useful clinical management criteria for children with respiratory diseases will have benefits for children in low resource regions around the world. The goals of the study are:~To determine if children with respiratory distress can be reliably diagnosed under low-resource conditions.~To identify the clinical tests that best differentiate pneumonia from wheezy diseases. These will be used to establish updated diagnostic criteria for common pediatric lung diseases that broaden the current pneumonia algorithm by adding another for wheezy illnesses.~The ultimate objective is to improve the management and outcome of acute respiratory conditions in children.~Investigators also wish to test the efficacy of a locally developed cell phone oximeter probe in a low resource setting.", - "NCTID": "NCT01997047" - }, - { - "brief_title": "Pilot Study for the SQUEEZE Trial", - "phase": "Phase 3", - "drugs": "['Fluid Sparing Resuscitation Strategy']", - "drugs_list": [ - "Fluid Sparing Resuscitation Strategy" - ], - "diseases": "['Septic Shock']", - "diseases_list": [ - "Septic Shock" - ], - "enrollment": "53.0", - "inclusion_criteria": "inclusion criteria: \n\n inclusion criteria for 1 and 3 must be answered YES to be eligible for study. \n\n 1. Age 29 days to less than 18 years of age \n\n 2a) Patient has Persistent Signs of Shock including one or more of the following: i) Vasoactive Medication Dependence ii) Hypotension (Systolic Blood Pressure and/or Mean Blood Pressure less than the 5th percentile for age) iii) Abnormal Perfusion (2 or more of: abnormal capillary refill, tachycardia, decreased level of consciousness, decreased urine output) \n\n 2b) Suspected or Confirmed Septic Shock (Shock due to Suspected or Confirmed Infectious Cause) \n\n 2c) Patient has received initial fluid resuscitation of: Minimum of 40 mL/kg of isotonic crystalloid (0.9% Normal Saline and/or Ringer's Lactate) and/or colloid (5% albumin) as fluid boluses within the previous 6 hours for patients weighing less than 50 kg, OR Minimum of 2 litres (2000 mL) of isotonic crystalloid (0.9% Normal Saline and/or Ringer's Lactate) and/or colloid (5% albumin) as fluid boluses within the previous 6 hours for patients weighing 50 kg or more \n\n 3. Patient has Fluid Refractory Septic Shock as defined by the Presence of all of 2a, 2b, and 2c. \n\n ", - "exclusion_criteria": ": \n\n Patient admitted to the Neonatal Intensive Care Unit (NICU) \n\n Patient requiring resuscitation in the Operating Room (OR) or Post-Anesthetic Care Unit (PACU) \n\n Full active resuscitative treatment not within the goals of care \n\n Shock Secondary to Cause other than Sepsis (i.e. obvious signs of cardiogenic shock, anaphylactic shock, hemorrhagic shock, spinal shock) \n\n Previous enrolment in this trial, where known by the research team", - "brief_summary": "The purpose of the SQUEEZE Trial is to determine which fluid resuscitation strategy results in the best outcomes for children treated for suspected or confirmed septic shock. In this study, eligible children will be randomized to either the 'Usual Care Arm' or the 'Fluid Sparing Arm'. Children will receive treatment according to current ACCM Septic Shock Resuscitation Guidelines, with the assigned resuscitation strategy used to guide administration of further fluid boluses as well as the timing of initiation and escalation of vasoactive medications to achieve ACCM recommended hemodynamic targets.", - "NCTID": "NCT01973907" - }, - { - "brief_title": "Evaluation of Lung Doppler Signals in Pulmonary Hypertension", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pulmonary Hypertension']", - "diseases_list": [ - "Pulmonary Hypertension" - ], - "enrollment": "45.0", - "inclusion_criteria": "inclusion criteria: \n\n Prospective arm: \n\n Man or woman aged over 18. \n\n With suspicion or diagnosis of pulmonary hypertension. \n\n Scheduled to undergo right heart catheterization \n\n Able and willing to give informed consent. \n\n Retrospective arm: \n\n Man or woman aged over 18. \n\n With diagnosis of pulmonary hypertension confirmed by right heart catheterization in the past. \n\n Able and willing to give informed consent. \n\n ", - "exclusion_criteria": ": \n\n Both arms: \n\n Minor (aged < 18). \n\n People unable or unwilling to give informed consent. \n\n Hemodynamically unstable patients. \n\n Pregnant women. \n\n Prospective arm only: \n\n Patients with contra-indication to right heart catheterization. \n\n Patients incapable of performing a Valsalva maneuver. \n\n Patients with recent myocardial infarction, high degree AV block, severe aortic stenosis or glaucoma", - "brief_summary": "The purpose of this study is to evaluate the lung Doppler signals in patients with pulmonary hypertension that undergo (prospective arm) or underwent (retrospective arm) right heart catheterization (RHC) in order to assess whether this non-invasive tool could be used in pulmonary hypertension diagnosis and monitoring.", - "NCTID": "NCT01839786" - }, - { - "brief_title": "Study of OLT1177 Gel to Treat Moderate to Severe OA Knee Pain", - "phase": "Phase 2", - "drugs": "['Placebo Gel', 'OLT1177 Gel']", - "drugs_list": [ - "Placebo Gel", - "OLT1177 Gel" - ], - "diseases": "['Osteoarthritis', 'Pain']", - "diseases_list": [ - "Osteoarthritis", - "Pain" - ], - "enrollment": "202.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 45 to 80 years old, inclusive \n\n Clinical diagnosis of osteoarthritis in one target knee based on the following American College of Rheumatology (ACR) criteria: \n\n Knee Pain \n\n At least 1 of 3: \n\n Age > 50 years \n\n Morning stiffness lasting < 30 minutes \n\n Crepitus on motion \n\n Osteophytes on radiograph \n\n Symptoms associated with osteoarthritis of the knee (including pain) for \u2265 6 months prior to Screening \n\n Knee pain associated with osteoarthritis, which required NSAID or other therapy for \u2265 15 days during the preceding month \n\n Radiographic evidence of osteoarthritis by Kellgren-Lawrence classification with a rating of Grade 2 or 3 in the target knee (does not include borderline Grade 2), as confirmed by the Sponsor's designated rheumatologist through radiographic review of x-ray(s) taken no more than 1 year prior to the Screening visit. (Sharpening of the tibial spine is not considered to be an osteophyte) (See Appendix 4 for additional details) \n\n Meets pain assessment entry criteria as defined by Sponsor's pain eligibility algorithm and calculated by the study Interactive Web Response System \n\n No clinically significant change in physical activity and/or therapy for the past 3 months \n\n Able to provide written informed consent prior to initiation of any clinical trial-related procedures; and willing and able, in the opinion of the Investigator, to comply with all requirements of the clinical trial for the duration of the trial (such requirements include, but are not limited to: attending all study visits, refraining from elective surgery or extensive travel during participation) \n\n ", - "exclusion_criteria": ": \n\n General \n\n Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential may not be entered into the study if: \n\n They are or intend to become pregnant (including use of fertility drugs) during the study \n\n They are nursing \n\n They are not using an acceptable, highly effective method of contraception until all follow-up procedures are complete. (Acceptable, highly effective forms of contraception are defined as: oral contraception, intrauterine device, systemic [injectable or patch] contraception, double barrier methods, naturally or surgically sterile, strict abstinence or partner has been sterilized. If hormonal-based birth control is being used, subject or subject's sexual partner(s) must be on a stable-dose for \u2265 3 months prior to the Baseline visit and maintained at the same dosing level throughout the 9-week clinical trial.) \n\n Body Mass Index (BMI) over 40 \n\n A history of osteoarthritis symptoms that are completely non-responsive to non-steroidal anti-inflammatory drugs (NSAIDs) at the discretion of the Investigator \n\n Planned change (increase or decrease) in subject's level of physical activity (e.g., aerobic or anaerobic exercise) during the 6-week Treatment Period following randomization \n\n Enrollment in any trial and/or use of any Investigational Drug or device within the immediate 30-day period prior to the Baseline visit \n\n Enrollment in any study previously sponsored by Olatec Industries LLC, specifically Study OLT1177-01 or OLT1177-02 \n\n Pain Related \n\n Does not meet pain assessment entry criteria as defined by Sponsor's pain eligibility algorithm and calculated by the study Interactive Web Response System \n\n Clinically significant joint (other than the knee) or general pain at Baseline, at the discretion of the Investigator \n\n Musculoskeletal Related \n\n Clinically significant, excessive effusion heat and/or redness in the target knee as determined by the Investigator \n\n Knock-kneed or bow-legged, as defined by a valgus or varus deformity of \u2265 15 degrees \n\n Radiographic evidence of osteoarthritis by Kellgren-Lawrence classification with a rating of Grade 0, 1 or 4 in the target knee, as confirmed by the Sponsor's designated rheumatologist through radiographic review of x-ray(s) taken no more than 1 year prior to the Screening visit (sharpening of the tibial spine is not considered to be an osteophyte) \n\n Documented history of clinically significant pain associated with osteoarthritis of the spine or hips, at the discretion of the Investigator \n\n Significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or chondromalacia \n\n Clinically significant medio-lateral and/or anterior-posterior instability, at the discretion of the Investigator \n\n Open surgery of the target knee within the prior year or surgery to the contralateral knee or other weight-bearing joint within the prior year, if at the discretion of the Investigator it would interfere with the study. If subject had open surgery more than one-year prior, Sponsor's designated rheumatologist must confirm that such surgery did not have any negative impact or consequence to the target knee (e.g., deformity of angle to the bone, bone on bone, locking joints, etc.) \n\n Arthroscopic surgery of the target knee within the prior six months \n\n Any acute or chronic injury, other than osteoarthritis in the target knee, that will be treated during the trial with any medication not allowed during the Treatment Period \n\n Prior surgery of the target knee requiring insertion of a medical device or surgical hardware (e.g., screws) \n\n Any major trauma or injury (including sports injuries) to the target knee in the past 12 months \n\n Documented history of inflammatory joint disease, including but not limited to: rheumatoid arthritis, gout, pseudogout, Paget's disease, psoriatic arthritis, ankylosing spondylitis, chronic inflammatory disease (e.g., colitis), fibromyalgia (diagnosed in accordance with ACR criteria, as applicable), articular fracture, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders (e.g., hypermobility) or collagen gene mutations \n\n Any planned interventional and/or surgical procedure during the 6-week Treatment Period following randomization \n\n Concomitant Conditions, Diseases, Medications/Therapies and Medical History Related \n\n Any use of Rescue Medication within 24 hours prior to the Baseline visit or use of any other pain medication within 7 days prior to Baseline visit \n\n Uncontrolled hypertension, defined as blood pressure \u2265 150/95 mmHg \n\n A history of uncontrolled and untreated diabetes mellitus with an HbA1c level > 8; or blood sugar levels that are outside of the normal range and HbA1c level > 8 is subsequently confirmed \n\n Any inflammatory skin condition over the target knee application area \n\n Use of any prohibited concomitant medications/therapies during the 7-day Washout Period or planned use of any prohibited concomitant medications/therapies during the 6 week Treatment Period \n\n Use of intraarticular or intramuscular steroids in the target knee within the previous 3 months or in any other joint within the previous 30 days \n\n Use of intraarticular hyaluronate in the target knee within the previous 6 months or in any other joint within the previous 30 days \n\n Current substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse (including alcoholism and/or addiction to pain medications) that is determined at the discretion of the Investigator as likely to interfere with trial assessments or recur during the trial \n\n Use of any systemic (oral or parenteral) corticosteroids within the prior month \n\n Uncontrolled psychiatric conditions (e.g., mania, depression, anxiety, substance dependence of any kind) that would impair the subject from safely participating in the trial, including completing any protocol requirements \n\n Evidence of cognitive impairment including dementia that may interfere with subject's ability to complete daily pain diaries requiring recall of average pain level in the past 24 hours \n\n Significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological or neurological disease or prior surgery that may interfere with the subject successfully completing the trial, including completing any protocol requirements as determined by the Investigator \n\n History of or known positive for HIV, Hepatitis B surface antigen (HBsAg) or antibodies to Hepatitis C Virus (HCV) \n\n Diagnosed with any form of cancer within the past 5 years, except for treated basal cell or squamous cell carcinoma of the skin \n\n Any other medical conditions, diseases or prior surgeries that in the opinion of the Investigator would impair the subject from safely participating in the trial and/or completing any protocol requirements \n\n Active infection within 3 days of the Baseline visit", - "brief_summary": "The objectives of this trial are to investigate the efficacy and safety of six weeks of treatment with OLT1177 Gel in subjects with moderate to severe pain associated with osteoarthritis of the knee following cessation of pain therapy.", - "NCTID": "NCT02104050" - }, - { - "brief_title": "Transcranial Magnetic Stimulation for Focal Hand Dystonia", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Dystonia']", - "diseases_list": [ - "Dystonia" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Confirmed diagnosis of focal hand dystonia (patients only). \n\n Between age 18 and 70 years. \n\n Able to give informed consent \n\n Right handed \n\n Agrees to not drink caffeine or alcohol for 48 hours before study session. \n\n No open scalp wounds or scalp infections. \n\n ", - "exclusion_criteria": ": \n\n Has used illegal drugs within the past 6 months based on history, including but not limited to marijuana, cocaine, methamphetamine, etc. The intent is to exclude those with drug use that may affect study results. Participants who appear to be intoxicated at the time of testing will be rescheduled. \n\n Has more than 7 alcoholic drinks a week in the case of a woman and 14 alcoholic drinks a week in the case of a man. \n\n Abnormal findings on neurologic exam (other than dystonia in patient group) \n\n Has had a brain tumor, a stroke, traumatic brain injury, epilepsy or a history of seizures. \n\n Has major depression or any major mental disorders (axis I disorders) \n\n Has a neurologic disorder other than dystonia \n\n Has had a head injury where there was a loss of consciousness for more than a few seconds. \n\n Has a pacemaker, intracardiac lines, implanted pumps or stimulators, or has metal objects inside the eye or skull. Dental fillings and dental braces are allowed. \n\n Has known hearing loss. \n\n Pregnancy \n\n Taking any medication that acts as a central nervous system stimulant or that is known to lower seizure threshold, including, imipramine, amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, (MDMA, ecstasy), phencyclidine (PCP, angel s dust), ketamine, gamma-hydroxybutyrate (GHB), alcohol, theophylline, mianserin, fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, reboxetine, venlafaxine, duloxetine, bupropion, mirtazapine, fluphenazine, pimozide, haloperidol, olanzapine, quetiapine, aripiprazole, ziprasidone, risperidone, chloroquine, mefloquine, imipenem, penicillin, ampicillin, cephalosporins, metronidazole, isoniazid, levofloxacin, cyclosporin, chlorambucil, vincristine, methotrexate, cytosine arabinoside, BCNU, lithium, anticholinergics, antihistamines, and sympathomimetics. \n\n Has excessive daytime sleepiness as indicated by a score of 10 or higher on the Epworth Sleepiness Scale.", - "brief_summary": "Background:~The brain has natural electrical rhythms of brain activities. These rhythms may be different in people with movement disorders, such as dystonia (involuntary muscle movement, cramps, or tremors). Understanding these rhythms may provide more information about movement disorders.~Focal hand dystonia, also known as writer's cramp or musician's cramp, is a painful condition that affects the hand and arm muscles. Researchers want to use transcranial magnetic stimulation (TMS) to study brain rhythms in people with and without focal hand dystonia.~Objectives:~- To better understand brain rhythms involved in focal hand dystonia.~Eligibility:~Individuals between 18 and 70 years of age who are right-handed and have focal hand dystonia.~Healthy right-handed volunteers between 18 and 60 years of age.~Design:~Participants will be screened with a physical exam and medical history.~This study includes two tests: a pilot test and a main test. The pilot test will determine the frequency of TMS that will be used in the main test. Participants may be in one or both tests. Each test requires a single outpatient visit that will last up to 5 hours.~Participants will have a base test to see how their muscles respond to TMS. This will look at the electrical activity of the muscles. Participants will have a wire coil held on their scalp. A brief electrical current will pass through the coil. It creates a magnetic pulse that stimulates the brain. Researchers will test the TMS on the right and left sides of the head. This will help find the spot that activates the finger muscles, and see how much TMS is needed.~In the main test, participants will have repetitive TMS (rTMS). rTMS involves repeated magnetic pulses delivered in short bursts. There will be four pulses in each burst. Participants will have multiple bursts during the test. This test will look at how the muscles of the hand and fingers respond to brain stimulation.~Treatment for focal hand dystonia will not be provided as part of this study.", - "NCTID": "NCT01792336" - }, - { - "brief_title": "Maintenance of Effect of Duloxetine in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)", - "phase": "Phase 4", - "drugs": "['Duloxetine']", - "drugs_list": [ - "Duloxetine" - ], - "diseases": "['Diabetic Neuropathies']", - "diseases_list": [ - "Diabetic Neuropathies" - ], - "enrollment": "216.0", - "inclusion_criteria": "inclusion criteria: \n\n Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months. \n\n May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study. \n\n Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item. \n\n ", - "exclusion_criteria": ": \n\n History of substance abuse or dependence within the past year, excluding nicotine and caffeine. \n\n Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis),kidney, respiratory, or blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or be likely to lead to hospitalization during the course of the study. \n\n Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study. \n\n Treatment with fluoxetine within 30 days of starting the study. \n\n Unstable blood sugar control and uncontrolled or poorly controlled hypertension.", - "brief_summary": "To determine if duloxetine 60 mg once daily can work up to 6 months in treating pain from Diabetic Neuropathy.", - "NCTID": "NCT00322621" - }, - { - "brief_title": "Pre-discharge vs. Early Post-discharge Stress Testing and GRACE Score for Safe Discharge of ACS-patients With a Negative Hs-troponin T Result", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Troponin T', 'Major Adverse Cardiovascular Events', 'GRACE Score']", - "diseases_list": [ - "Troponin T", - "Major Adverse Cardiovascular Events", - "GRACE Score" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n patients presenting to the emergency department (chest pain unit) \n\n typical angina pectoris \n\n absence of symptoms since presentation \n\n at least 18 years \n\n low GRACE risk score (<140 points) \n\n informed consent, signed agreement \n\n ", - "exclusion_criteria": ": \n\n conditions with need for immediate workup \n\n mental disorders \n\n dementia \n\n pregnancy, breast feeding", - "brief_summary": "New high-sensitivity cardiac troponin (hs-cTn) assays allow earlier detection of acute myocardial infarction (AMI). Furthermore, elevated values were associated with an increased risk of recurrent AMI or death. Therefore, guidelines recommend an early invasive strategy in patients with elevated admission values and kinetic changes. Other criteria for an early invasive strategy include a GRACE risk score >140 points or other cardiovascular risk factors. Hs-cTn assays allow discrimination of patients at very low and high risk. Studies confirmed safety of early discharge protocols in patients with unstable angina (UAP). The aim of this study is to 1) confirm the safety of early discharge without invasive strategy in patients with UAP and to 2) review the optimal timing of stress-testing. Therefore, patients are being randomized into 2 groups with pre-discharge and early post-discharge stress-testing. Endpoints are major adverse cardiovascular events within 30 and 90 days.", - "NCTID": "NCT02072538" - }, - { - "brief_title": "Hypoalgesic Effects Neural Mobilization Techniques", - "phase": "Phase 1", - "drugs": "['Neural Glide', 'Neural stretching']", - "drugs_list": [ - "Neural Glide", - "Neural stretching" - ], - "diseases": "['Hyperalgesia']", - "diseases_list": [ - "Hyperalgesia" - ], - "enrollment": "45.0", - "inclusion_criteria": "inclusion criteria: \n\n Asymptomatic subjects who met the inclusion criterion of being between 18 and 30 years old. \n\n ", - "exclusion_criteria": ": \n\n rheumatologic diseases or any type of cancer, cervical surgery in the past, whiplash trauma and undergoing any type of treatment like physical therapy, manual therapy, osteopathy, chiropraxis, acupuncture during the last three months. All patients recruited for the study complained of pain localized in the neck and/or head region. Initial screening was accomplished by telephone and eligible persons attended a evaluation appointment. \n\n development of systemic or degenerative diseases \n\n subjects with symptoms of depression according Beck's questionnaire \n\n pain in any area between the lower back and head in the last 9 months \n\n traumatic event in the past 12 months \n\n history of neck or face pain in the last 6 months", - "brief_summary": "The purpose of this study was to evaluate the immediate mechanical hypoalgesic effect of neural mobilization in asymptomatic subjects. We also compared neural gliding versus neural stretching to see which produced greater hypoalgesic effects in asymptomatic subjects.", - "NCTID": "NCT02011477" - }, - { - "brief_title": "Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients With Chagas Disease", - "phase": "Phase 4", - "drugs": "['Implantable Cardiac Monitor', 'Standard of Care']", - "drugs_list": [ - "Implantable Cardiac Monitor", - "Standard of Care" - ], - "diseases": "['Chagas Disease', 'Heart Diseases']", - "diseases_list": [ - "Chagas Disease", - "Heart Diseases" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria: \n\n Have Chagas disease, confirmed by two serological tests. \n\n Provide evidence through any of the following diagnosis methods: Rest ECG, 24 hour Holter monitoring, electrophysiological study, stress test or loop monitoring, at least one electrical disorder consistent with sinus bradycardia greater than 45 and lower than 60 bpm, sinus arrest not greater than 2.0 seconds, second degree atrial sinus block, intraventricular conduction disorders such as right branch, left branch or a bifascicular blockage type, first degree A-V blockage, or of type I second degree AV Block without associated bradycardia, atrial and/or ventricular arrhythmias that do NOT constitute an indication for pacemaker implant, ICD or mapping and radio frequency ablation. \n\n Be asymptomatic or having minimal isolated unspecific symptoms not consistent with cardiac arrest, aborted sudden death, syncope, frequent and recurrent palpitations, cardiac failure, and lower extremity edema. \n\n Have ejection fraction of left ventricle >35% \n\n Be able to give his/her written informed consent. \n\n Subject should be > 21 years old. \n\n Be able to return for follow-up visits as required. \n\n ", - "exclusion_criteria": ": \n\n Class I or II (according to AHA/HRS/ESC guidelines) indication for final implantation of pacemaker, ICD, or cardiac resynchronizer. \n\n Exhibit extrinsic causes of sinus dysfunction or A-V blockage. \n\n Exhibit infiltrative myocardial diseases such as tumors or associated valvular defects. \n\n Suffer any concurrent disease that may limit the follow up or evaluation. \n\n Suffer aftereffects of cerebral embolism. \n\n Suffer ablation or isolation of pulmonary veins previous to their inclusion in the study. \n\n Not being able or willing to comply with the follow-up schedule. \n\n Have previous lesions of the spinal cord or aftereffects of skull trauma. \n\n Have a record of epilepsy. \n\n Receive pharmacological treatment for other diseases that may modify the autonomic function. \n\n Have a record of myocardial infarction. \n\n History of alcohol abuse or drug addiction. \n\n History of emotional instability, unstable psychiatric disorders or are under treatment for such disorders. \n\n Have previously implanted pacemakers, cardiodefibrillators or CRT systems. \n\n Are included or intend to participate in another study of devices during the course of this study. \n\n Have a clinical condition that may limit life expectancy to < 36 months. \n\n Use of Antiarrhythmic drugs, except Beta Blockers", - "brief_summary": "The study Reveal Chagas: Clinical Evidence of the Implantable Cardiac Monitor in Patients with Chagas Disease is a prospective, multicenter, randomized study that is being conducted at several centers in Latin America with commercially available products.~The primary study hypothesis is that patients with implantable cardiac monitors will have a shorter time to the decision to treat for electrical or arrhythmic disorders during the follow-up period.~The geography includes Argentina and Colombia.", - "NCTID": "NCT01539161" - }, - { - "brief_title": "Transpulmonary Thermodilution and Transesophageal Echocardiography in Early Septic Shock", - "phase": "Phase 4", - "drugs": "['early septic shock']", - "drugs_list": [ - "early septic shock" - ], - "diseases": "['Septic Shock']", - "diseases_list": [ - "Septic Shock" - ], - "enrollment": "153.0", - "inclusion_criteria": "inclusion criteria: \n\n ventilated patient in sinus rhythm with septic shock requiring a hemodynamic assessment \n\n ", - "exclusion_criteria": ": \n\n < 18 yr-old \n\n pregnancy \n\n contra-indication for TEE, non sinus rhythm, aplasia, prior participation to the study, hemodynamic assessment using any other technique than those tested in the study.", - "brief_summary": "The purpose of this study is to assess the concordance of therapeutic changes proposed after an early hemodynamic evaluation (hemodynamic profile) in septic shock patients using jointly the transpulmonary thermodilution technique and transesophageal echocardiography (TEE).", - "NCTID": "NCT01188993" - }, - { - "brief_title": "Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI", - "phase": "", - "drugs": "['Lamotrigine', 'Placebo (for Lamotrigine)']", - "drugs_list": [ - "Lamotrigine", - "Placebo (for Lamotrigine)" - ], - "diseases": "['Facial Neuropathy']", - "diseases_list": [ - "Facial Neuropathy" - ], - "enrollment": "6.0", - "inclusion_criteria": "inclusion criteria: \n\n 18-60 years of age \n\n Right-handed non-smokers \n\n Diagnosed with facial pain \n\n Continuous pain for more than 3 months \n\n Spontaneous pain greater than 3 of 10 \n\n Allodynia to brush greater than 5 of 10 \n\n ", - "exclusion_criteria": ": \n\n Medications \n\n Depression \n\n Significant medical problems \n\n Claustrophobia \n\n Abnormal EKG \n\n Significant drug or alcohol history \n\n Positive drug screen \n\n Weight greater than 285 lbs \n\n History of allergy to anticonvulsants \n\n Tattoos with metallic ink on upper body \n\n Any neurostimulator devices, or metal cochlear, ocular, or cardiac implants or other metal near vital areas \n\n Exposure to shrapnel or metal filings \n\n Other metallic surgical hardware", - "brief_summary": "The aim of this project is to evaluate the effects of the anticonvulsant drug lamotrigine (trade name Lamictal) on neuropathic facial pain or neuralgia using functional magnetic resonance imaging (fMRI).", - "NCTID": "NCT00243152" - }, - { - "brief_title": "Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of ACT-389949", - "phase": "Phase 1", - "drugs": "['ACT-389949 1 mg', 'ACT-389949 5 mg', 'ACT-389949 20 mg', 'ACT-389949 50 mg', 'ACT-389949 100 mg', 'ACT-389949 200 mg', 'ACT-389949 500 mg', 'ACT-389949 1000 mg', 'Placebo']", - "drugs_list": [ - "ACT-389949 1 mg", - "ACT-389949 5 mg", - "ACT-389949 20 mg", - "ACT-389949 50 mg", - "ACT-389949 100 mg", - "ACT-389949 200 mg", - "ACT-389949 500 mg", - "ACT-389949 1000 mg", - "Placebo" - ], - "diseases": "['Healthy Subjects']", - "diseases_list": [ - "Healthy Subjects" - ], - "enrollment": "65.0", - "inclusion_criteria": "inclusion criteria: \n\n Signed informed consent prior to any study-mandated procedure. \n\n Healthy Caucasian male subjects aged between 18 and 45 years (inclusive) at screening. \n\n Subjects must agree to use reliable methods of contraception. \n\n No clinically significant findings on physical examination at screening. \n\n Body mass index (BMI) between 18.0 and 30.0 kg/m^2 (inclusive) at screening. \n\n Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate (PR) 45-90 bpm (inclusive) measured at screening. \n\n 12-lead ECG without clinically relevant abnormalities, measured at screening. \n\n Body temperature (T\u00b0) 35.5-37.5\u00b0C at screening and prior to (first) dosing. \n\n Total and differential white blood cell (WBC) count strictly within the normal ranges at screening and on Day -1. \n\n C-reactive protein (CRP) levels below 5 mg/L. \n\n Hematology and clinical chemistry results (other than total and differential WBC count and CRP) not deviating from the normal range to a clinically relevant extent at screening. \n\n Coagulation and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening. \n\n Non smokers, defined as never smoked or achieved cessation for \u2265 6 months at screening. \n\n Negative results from urine drug screen at screening. \n\n Subjects allowing the conduct of genetic analyses on whole blood consisting of measuring the levels of messenger ribonucleic acid (mRNA) expression of mechanistic biomarkers of N-formyl-peptide receptor 2 (FPR2) and proteins involved in inflammation. \n\n Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study. \n\n ", - "exclusion_criteria": ": \n\n Known allergic reactions or hypersensitivity to any excipient of the drug formulation. \n\n History or clinical evidence of any disease, and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug. \n\n Previous history of recurrent fainting, collapses, syncope, orthostatic hypotension, or vasovagal reactions. \n\n Veins unsuitable for intravenous (i.v.) puncture on either arm. \n\n Treatment with another investigational drug within 3 months prior to screening or having participated in more than four investigational drug studies within 1 year prior to screening. \n\n History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening. \n\n Excessive caffeine consumption. \n\n Treatment with any prescribed or over-the-counter (OTC) medications within 2 weeks prior to (first) study drug administration or five half-lives of the medication, whichever is longer. \n\n Any history of immunosuppressive treatment. \n\n Chronic diseases including those with recurring periods of flare-ups and remission. \n\n History of atopic allergy (including asthma, urticaria, eczematous dermatitis). \n\n Signs of infection (viral, systemic fungal, bacterial or protozoal) within 4 weeks prior to (first) study drug administration. \n\n History of acute or chronic obstructive lung disease (treated or not treated). \n\n History of subarachnoid hemorrhage or hemolytic uremic syndrome. \n\n Interval from the beginning of the P wave to the beginning of the QRS complex (PQ/PR interval) < 120 ms at screening. \n\n Loss of 250 mL or more of blood, or an equivalent amount of plasma, within 3 months prior to screening. \n\n Positive results from the hepatitis serology, except for vaccinated subjects or subjects with past but resolved hepatitis, at screening. \n\n Positive results from the human immunodeficiency virus serology at screening. \n\n Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol. \n\n Legal incapacity or limited legal capacity at screening.", - "brief_summary": "This is a prospective, single-center, double-blind, randomized, placebo-controlled, ascending single oral dose and food interaction Phase 1 study. It will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending single oral doses of ACT-389949 in healthy male subjects. It will also investigate the effect of food on the pharmacokinetics, safety, and tolerability of a single dose of ACT-389949.", - "NCTID": "NCT02099071" - } - ], - "1": [ - { - "brief_title": "Use of PiCCO System in Critically Ill Patients With Septic Shock and Acute Respiratory Distress Syndrome", - "phase": "Phase 1; Phase 2", - "drugs": "['PiCCO monitoring (PULSION)', 'central venous catheter']", - "drugs_list": [ - "PiCCO monitoring (PULSION)", - "central venous catheter" - ], - "diseases": "['Septic Shock', 'Acute Respiratory Distress Syndrome']", - "diseases_list": [ - "Septic Shock", - "Acute Respiratory Distress Syndrome" - ], - "enrollment": "350.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients were included if they were diagnosed with Shock, Acute respiratory distress syndrome (ARDS), or both. \n\n Shock was defined by the presence 4 criteria: \n\n Heart rate of at least 90/min; \n\n A respiratory rate of at least 20/min or a PaCO2 of 32mmHg or lower or the use of mechanical ventilation; \n\n The use of vasopressors to maintain a systolic blood pressure of at least 90mmHg despite fluid resuscitation, low dose of dopamine (\u2264 5 \u03bcg/kg per minute), or dobutamine; \n\n at least 1 of 3 signs of hypoperfusion (urine output < 0.5mL/kg of body weight per hour for 1 hour or more; neurologic dysfunction defined by confusion, psychosis, or a Glasgow coma scale score of \u2264 6; plasma lactate higher than the upper limit of the normal value). \n\n Acute respiratory distress syndrome\uff1a \n\n the presence of acute decrease in PaO2/FIO2 to 200mmHg or lower, \n\n bilateral pulmonary infiltrates or a chest radiograph consistent with edema; \n\n no clinical evidence of left atrial hypertension; and requirement for positive pressure ventilation. \n\n ", - "exclusion_criteria": ": \n\n Patients were moribund. \n\n signed do-not-resuscitation odor.", - "brief_summary": "PiCCO has been widely used in critical care settings for several decades. Together with pulmonary artery catheter, it is regarded as the important tool for guiding fluid management in patients with shock or acute respiratory distress syndrome. However, its effects on patients' outcome remain untested. The investigators study is a pilot study that is designed to test whether the use of PiCCO will improve patients' outcome, as compared to those without PiCCO monitoring.", - "NCTID": "NCT01526382" - } - ], - "2": [ - { - "brief_title": "Measuring Changes in Acute Pain in the Emergency Department Using Patient Reported Scales", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Acute Pain']", - "diseases_list": [ - "Acute Pain" - ], - "enrollment": "3630.0", - "inclusion_criteria": "inclusion criteria: \n\n Reported pain greater than or equal to 3 out of 10 \n\n ", - "exclusion_criteria": ": \n\n Less than 18 years of age \n\n Decreased level of consciousness \n\n Inability to answer questions \n\n Prisoner", - "brief_summary": "Patient reported pain, stress, and anxiety measures have been found to be inter-related, but it is not known if they are all associated with receiving opiate medications. The objective of this study is to determine if patients' degree of reported pain, stress, or anxiety is associated with receiving opiate pain medications in the emergency department or at discharge. Alert patients at least 18 years of age and who report pain greater than 3/10 are eligible to participate in the study. Consenting patients complete Visual Analog Scales describing their perceived pain, stress, and anxiety from enrollment until discharge. Demographic data and administration of pain medication is also recorded. Visual Analog Scale scores among patients who received an opioid pain medicine in the emergency department and at discharge will be compared to those who did not.", - "NCTID": "NCT01723137" - } - ] - }, - { - "patient_id": "sigir-201412", - "patient": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", - "0": [ - { - "brief_title": "Levothyroxine Treatment for Subclinical Hypothyroidism After Head and Neck Surgery", - "phase": "Phase 2; Phase 3", - "drugs": "['Levothyroxine', 'Placebo']", - "drugs_list": [ - "Levothyroxine", - "Placebo" - ], - "diseases": "['Hypothyroidism', 'Neoplasms', 'Postoperative Complications']", - "diseases_list": [ - "Hypothyroidism", - "Neoplasms", - "Postoperative Complications" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Biopsy proven head and neck cancer, as defined by AJCC staging system \n\n Treated with surgery in Edmonton, Alberta \n\n Treated with curative intent \n\n Diagnosis of sub-clinical hypothyroidism after head and neck surgery (TSH 4-10mIU/L, and free T4 10-24pmol/L) \n\n ", - "exclusion_criteria": ": \n\n Head and neck cancer of the thyroid gland, or other subsite involving the thyroid gland \n\n Underwent previous treatment for a different head and neck cancer \n\n History of radiation therapy and or chemotherapy to the head and neck \n\n History of thyroid disease as follows: \n\n Hypothyroidism \n\n Hyperthyroidism \n\n Autoimmune thyroid disease including Grave's disease and Hashimoto's thyroiditis \n\n History of thyroiditis \n\n History of diabetes mellitus \n\n History of long term steroid usage \n\n History of immunocompromise \n\n History of thyroid surgery \n\n History of ischemic heart disease \n\n Age >80 \n\n Patients taking a medication that may alter the metabolism or interact with levothyroxine, which they cannot safely stop (see Appendix A).", - "brief_summary": "Patients that require treatment for cancers of the head and neck often require a combination of surgery and/or radiation and chemotherapy. Hypothyroidism is one of the most common complications, and has been associated with post-operative complications such as wound healing problems, fistula formation, and decreased quality of life and survival. Several studies have examined hypothyroidism after radiation to the head and neck, but few have examined this after non-thyroid head and neck surgery. Head and neck resection is theorized to devascularize the thyroid, thus resulting in post-operative hypothyroidism.~Synthroid is a synthetic thyroid hormone often used in cases of patients with proven hypothyroidism and after surgical thyroid removal. It's use has been in effect and studied for over fifty years.~Treatment algorithms for hypothyroidism are well published. However, treatment of subclinical hypothyroidism (elevated TSH with normal or near-normal T3/T4) is controversial. The rate of subclinical hypothyroidism after non-thyroid head and neck surgery is high (up to 20%), and is associated with post-operative complications as noted above.~Therefore the investigators propose a double blinded randomized controlled trial comparing outcomes of patients that develop subclinical hypothyroidism after head and neck surgery, who are given a standardized dose of synthroid treatment versus those treated with placebo. The main outcomes to be examined are post-operative complications (wound healing issues, fistula formation), survival, and quality of life measures.", - "NCTID": "NCT02548715" - }, - { - "brief_title": "Thyroid Disorders in Malaysia: A Nationwide Multicentre Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Hypothyroidism', 'Subclinical Hypothyroidism', 'Hyperthyroidism', 'Subclinical Hyperthyroidism', 'Graves Disease', \"Hashimoto's Thyroiditis\", 'Iodine Deficiency', 'Genetic Susceptibility']", - "diseases_list": [ - "Hypothyroidism", - "Subclinical Hypothyroidism", - "Hyperthyroidism", - "Subclinical Hyperthyroidism", - "Graves Disease", - "Hashimoto's Thyroiditis", - "Iodine Deficiency", - "Genetic Susceptibility" - ], - "enrollment": "2498.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged equal or more than 18 years old at the time of sampling \n\n Malaysian citizen \n\n ", - "exclusion_criteria": ": \n\n Respondents who did not give consent", - "brief_summary": "This will be a population based study looking at the prevalence of thyroid disorders in Malaysia (including hypo- and hyperthyroidism, subclinical hypo- or hyperthyroidism) and its association with different ethnicity and iodine status. The study will also look at genetic susceptibility for autoimmune thyroid disorders in the Malaysian population~General hypotheses:~The prevalence of thyroid disorders in Malaysia is 10% for hypothyroidism and 2% for hyperthyroidism Hypo- and hyperthyroidism is associated with iodine status in our population There are different susceptibility gene for autoimmune thyroid disorder in different ethnicity in our population", - "NCTID": "NCT02190214" - }, - { - "brief_title": "Central Hypothyroidism, a Novel Laboratory Measurement", - "phase": "", - "drugs": "['Eltroxin']", - "drugs_list": [ - "Eltroxin" - ], - "diseases": "['Central Hypothyroidism']", - "diseases_list": [ - "Central Hypothyroidism" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical evidence of central hypothyroidism: status post pituitary surgery and/or radiotherapy plus laboratory documentation of central hypothyroidism, with or without concurrent hormonal deficiencies in other axes, such as ACTH, LH, FSH \n\n ", - "exclusion_criteria": ": \n\n Primary hypothyroidism", - "brief_summary": "Medical management of central hypothyroidism is controversial due to lack of reference for evaluation of pituitary negative feedback. Therefore, titration of medical treatment is based on T4 levels, measured with variable laboratory methods. Patients who have central hypothyroidism usually have concomitant deficiencies in other pituitary hormones for which they need replacement therapy such as steroids, testosterone and growth hormone. This combined hormone deficiency makes clinical and laboratory evaluation challenging among these patients. Symptomatically, central hypothyroidism is relatively mild and lack non-specific and it might be overlooked due to other hormonal deficiencies. Replacement therapy for central hypothyroidism is titrated by arbitrary target free T4 levels of above 50th percentile of normal. The goal of our study is to compare the standard results from well known measure methods to a new method for measuring Ft4 using Liquid chromatography - tandem mass spectrometry.", - "NCTID": "NCT01280292" - }, - { - "brief_title": "Effects of L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Hypothyroidism", - "phase": "Phase 4", - "drugs": "['L-thyroxine']", - "drugs_list": [ - "L-thyroxine" - ], - "diseases": "['Hypothyroidism', 'Thyroid Diseases', 'Endocrine System Diseases']", - "diseases_list": [ - "Hypothyroidism", - "Thyroid Diseases", - "Endocrine System Diseases" - ], - "enrollment": "700.0", - "inclusion_criteria": "inclusion criteria: \n\n 40 \n\n 75 years old \n\n Diagnosis of overt or subclinical hypothyroidism in two occasions with a minimum interval period of three months \n\n ", - "exclusion_criteria": ": \n\n Pregnant or lactating women \n\n Severe hepatic or renal dysfunction \n\n Psychiatric disabilities, acute cardiovascular and cerebrovascular diseases, chronic respiratory diseases, familiar hypercholesterolemia, malignancy, cholelithiasis, pancreatitis, bowel diseases and other disorders influencing lipid and bile acid metabolism \n\n Taking lipid-lowering agents and other drugs influencing thyroid function, lipid and bile acid metabolism \n\n Obviously poor compliance.", - "brief_summary": "Hypothyroidism is a common clinical entity which is often complicated by dyslipidemia. It is also reported increased risk for incidence of atherosclerosis and resulting coronary heart disease(CHD), heart failure(HF) and cardiovascular(CV) death. The effect of L-thyroxine replacement treatment on serum lipid and atherosclerosis is controversial in hypothyroid patients, especially in those with mild or moderate subclinical hypothyroidism. The present study was designed to investigate whether L-thyroxine replacement was effective in improving serum lipid profiles and retarding atherosclerosis progress.~Studies have shown that hypothyroidism increased the risk of COVID-19 composite poor outcomes. This study also aimed to investigate whether L-thyroxine replacement therapy was effective in reducing the incidence and mortality of COVID-19, and in improving the severity of COVID-19 and COVID-19 related complications.", - "NCTID": "NCT01848171" - }, - { - "brief_title": "The Effect of Plaquenil on Serum Inflammatory Markers and Goiter in Euthyroid Young Women With Hashimoto's Thyroiditis", - "phase": "", - "drugs": "['Hydroxychloroquine']", - "drugs_list": [ - "Hydroxychloroquine" - ], - "diseases": "[\"Hashimoto's Thyroiditis\"]", - "diseases_list": [ - "Hashimoto's Thyroiditis" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Newly diagnosed (within 1 year) Hashimoto's thyroiditis by positive serum anti-TPO antibody or anti-thyroglobulin antibody \n\n Euthyroid state by serum free T4 and TSH level within normal limit \n\n ", - "exclusion_criteria": ": \n\n Pregnant, planning pregnant within 1 year, or lactating women \n\n Renal insufficiency, abnormal liver function test \n\n Hematologic diseases: anemia, agranulocytosis, thrombocytopenia \n\n G6PD deficiency, porphyria cutaneous tarda \n\n Allergy to 4-aminoquinoline compounds \n\n Known retinopathy or visual field defect disorders \n\n Already receive immunosuppression therapy", - "brief_summary": "Hashimoto's thyroiditis (HT) is a common form of autoimmune thyroid disease, which affects up to 2% of general population. The annual incidence of HT worldwide is estimated to be 0.8 - 3.5 cases per 1000 persons. The thyroid gland attacked by a variety of cell- and antibody-mediated immune processes. Various auto-antibodies may be present against TPO and Tg, and ADCC is a substantial factor behind the apoptotic fall-out of HT. Activation of cytotoxic T-lymphocytes in response to cell-mediated immune response affected by helper T-cells is central to thyrocyte destruction. Recent studies showed higher pro-inflammatory cytokines in serum of patients with HT, and suggested HT is associated with regulatory T-cells dysfunction, imbalance of ratio of Th1 cell and Th2 cell, overexpression of Th17 cells.~Several studies suggested that pregnant women with HT, even at euthyroid state had higher risk of spontaneous miscarriage, more frequent post-partum depression and higher depressive, anger, and total mood disturbance risk compared to those without HT. Presence of thyroid auto-antibodies is also associated with negative pregnant outcomes including gestational hypertension, late abortion, fetal death, premature delivery and neonatal respiratory distress. Neonates from mothers with ATD have higher rate of transient hypothyroidism. Children of mothers with ATD had higher risk of positive serum thyroid auto-antibodies and development of goiter and thyroid dysfunction. However, there is no suggested treatment for subjects with HT who have normal thyroid function. Low-iodine diet and regularly follow-up were suggested.~Plaquenil (hydroxychloroquine) is an anti-malarial agent, and has been used to treat several autoimmune diseases, including lupus erythematosus and rheumatoid arthritis for more than a century. It reduced lymphocytes, production of auto-antibodies, cytokines, and immune mediators, NK cell activity, and inhibits antigens presenting to CD4 T-cells of B cells, dendritic cells and monocytes.~This study focuses on the effect of Plaquenil on thyroid auto-antibodies, inflammatory markers, cytokines, and goiter size in euthyroid women with HT.", - "NCTID": "NCT02126683" - }, - { - "brief_title": "Monitoring and Evaluation of the Levothyroxin Replacement Therapy in Pregnant Women With Hypothyroidism", - "phase": "", - "drugs": "['biomedical outcomes']", - "drugs_list": [ - "biomedical outcomes" - ], - "diseases": "['Hypothyroidism']", - "diseases_list": [ - "Hypothyroidism" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n Consecutive pregnant women with L-T4 treated hypothyroidism followed at the outpatient clinic at the Endocrinology Unit, Herlev Hospital, Denmark during 2012", - "exclusion_criteria": "", - "brief_summary": "The aim of the study was to evaluate the clinical control program in patients with hypothyroidism during pregnancy (suggested in resent guidelines). Is it possible by monitoring the patients every 4. week during pregnancy to keep the thyroid function parameters within the recommended range?~A retrospective study of consecutive pregnant women with hypothyroidism followed at the outpatient clinic at the Endocrinology Unit, Herlev Hospital, Denmark during 2012. Patients selected through electronic medical system. Blood tests for the The hormone levels drawn from the laboratory of Clinical Biochemical Department, Herlev Hospital", - "NCTID": "NCT02094079" - }, - { - "brief_title": "Central Hypothyroidism and Cardiovascular Risk", - "phase": "", - "drugs": "['levothyroxine']", - "drugs_list": [ - "levothyroxine" - ], - "diseases": "['Hypopituitarism']", - "diseases_list": [ - "Hypopituitarism" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients with pituitary hypopituitarism \n\n ", - "exclusion_criteria": ": \n\n Unavailability of data", - "brief_summary": "Retrospective trial of 300 patients with pituitary insufficiency treated in Department of Medica Endocrinology, Rigshospitalet, Copenhagen University concerning levothyroxine (T4) replacement and cardiovascular risk factors. The hypothesis is that subtle central hypothyroidism is associated with adverse cardiac risk factors, such as body composition and serum lipids, and that improved T4 replacement will eliminate this increased risk, independently of other pituitary hormone replacements.", - "NCTID": "NCT01574859" - }, - { - "brief_title": "Thyroxine Titration Study", - "phase": "Phase 4", - "drugs": "['Thyroxine']", - "drugs_list": [ - "Thyroxine" - ], - "diseases": "['Hypothyroidism']", - "diseases_list": [ - "Hypothyroidism" - ], - "enrollment": "55.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female subjects >18 years of age \n\n Primary hypothyroidism \u22656 months duration arising from autoimmune hypothyroidism, thyroidectomy or radioiodine treatment \n\n Thyroxine dose \u2265100 mcg/day \n\n No change in thyroxine dose in past 2 months \n\n Serum TSH of 0.1-4.8 mU/L \n\n Adequate contraceptive measures for women of childbearing age \n\n ", - "exclusion_criteria": ": \n\n Major systemic illness affecting quality of life or likely to affect participation in the study \n\n Treatment with T3 currently or in past 2 months \n\n History of thyroid cancer requiring suppression of TSH secretion by thyroxine \n\n Ischaemic heart disease - previous myocardial infarction, angina or coronary artery revascularisation \n\n Renal failure: serum creatinine >135 micromol/L \n\n Known liver disease with alkaline phosphatase or ALT >2x upper limit of reference range \n\n Bony fracture in past 3 months or Paget's disease of bone \n\n Secondary (central) hypothyroidism or hypopituitarism", - "brief_summary": "The aim of the study is to examine the effects of fine titration of thyroxine dosage on symptoms of hypothyroidism, wellbeing and quality of life. The hypothesis is that symptoms of hypothyroidism, wellbeing and quality of life will be improved in thyroxine-treated subjects when serum thyrotropin (TSH) is suppressed and/or in the lower reference range, compared to when TSH is in the upper reference range.", - "NCTID": "NCT00111735" - }, - { - "brief_title": "Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment", - "phase": "", - "drugs": "['Levothyroxine', 'Desiccated thyroid extract']", - "drugs_list": [ - "Levothyroxine", - "Desiccated thyroid extract" - ], - "diseases": "['Primary Hypothyroidism.']", - "diseases_list": [ - "Primary Hypothyroidism." - ], - "enrollment": "180.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients will be between the ages of 18 to 65 and will have been on levothyroxine for primary hypothyroidism for at least 6 months. \n\n ", - "exclusion_criteria": ": \n\n Patients will be excluded if they have the following problems: pregnancy, plan for pregnancy in the next 12 months, cardiac disease, especially coronary artery disease, chronic obstructive lung disease, malabsorption disorder, gastrointestinal surgeries, significant renal or liver dysfunction, seizure disorders, thyroid and non-thyroid active cancers, uncontrolled psychosis, psychotropic medication use, steroid use, amiodarone, chemotherapy for cancer, iron supplement more than 325mg per day, carafate/ proton pump inhibitor use, cholestyramine use, and those with recent PCS orders who are expected to move out of the geographic area, age less than 18 years old or older than 65 years old. \n\n Patients scheduled for deployment will be excluded.", - "brief_summary": "Our hypothesis is that hypothyroid patients on DTE may have a decrease in symptoms, an improvement of cognitive function, and an increase in sense of well-being/ quality of life equivalently compared with L-T4.", - "NCTID": "NCT01739972" - }, - { - "brief_title": "The Association of Costimulatory Molecules and PPAR-polymorphisms With Autoimmune Thyroid Disease in Taiwan", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['AITd Patients With Different Polymorphisms']", - "diseases_list": [ - "AITd Patients With Different Polymorphisms" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Autoimmune thyroid patients \n\n patients who cut Nodular Goiter in Wanfang Hospital \n\n ", - "exclusion_criteria": ": \n\n none", - "brief_summary": "Autoimmune thyroid disease is the most common organ-specific autoimmune disease. AITD include Graves' disease and Hashimoto's thyroiditis. Although the pathogenesis of AITD remains unclear, it is generally thought that the mechanisms of the disease is a complex disease in which susceptibility genes and environmental triggers act in concert to initiate the autoimmune response to the thyroid.~The initial step of thyroid autoimmunity is the activation of T cells. The activation of T cell requires two signals: firstly, thyroid follicular cells or antigen presenting cells binds to T cell receptor through antigenic HLA complex. Secondly, the activation of T cells is also required the interaction of costimulatory molecules between thyroid follicular cells and immune cells, including CTLA-4, CD 40, CD28, ICOS. PPAR- is a kind of intranuclear transcription factor, associated with adipogenesis and inflammation. Some reports showed that PPAR- polymorphism may have a protective effect from Graves' ophthalmopathy.~The goal of the study is to investigate the relationship among SNP and mRNA of costimulatory molecules and PPAR- , serum cytokine including TNF- and sIL-2R, and clinical characteristics in AITD patients. From the study, we hope to clarify the role of costimulatory molecules and PPAR- polymorphism in AITD.", - "NCTID": "NCT01260532" - }, - { - "brief_title": "Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children", - "phase": "Phase 3", - "drugs": "['thyroid hormone and folinic acid']", - "drugs_list": [ - "thyroid hormone and folinic acid" - ], - "diseases": "['Down Syndrome']", - "diseases_list": [ - "Down Syndrome" - ], - "enrollment": "175.0", - "inclusion_criteria": "inclusion criteria: \n\n patient with a karyotype demonstrating homogeneous, free or Robertsonian translocation trisomy 21 \n\n patient having undergone a cardiac ultrasound not demonstrating any severe heart disease \n\n patient aged 6 to 18 months at inclusion \n\n ", - "exclusion_criteria": ": \n\n congenital hypothyroidism \n\n hypothyroidism demonstrated by laboratory tests (TSH > 7mUI/l) \n\n presenting or having presented hyperthyroidism \n\n presenting or having presented leukaemia \n\n presenting or having presented West syndrome or any other form of epilepsy or unstable neurological disease \n\n presenting or having presented signs of central nervous system distress: stroke, postoperative hypoxia, meningitis) \n\n presenting severe heart disease on cardiac ultrasound, with haemodynamic effects \n\n presenting non-controlled cardiac arrhythmia \n\n Apgar < 7 to 5 min at birth \n\n Gestational age < 231 days (33 gestation weeks)", - "brief_summary": "Evaluation of the following in very young children with Down syndrome:~the efficacy of systematic treatment with L-thyroxine at controlled doses (clinically and by ultrasensitive thyreostimulating hormone (TSH) assay),~the efficacy of systematic folinic acid treatment at a dose of 1 mg/kg/o.i.d,~any interaction between these two treatments.", - "NCTID": "NCT01576705" - }, - { - "brief_title": "Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia", - "phase": "", - "drugs": "['thyroxine']", - "drugs_list": [ - "thyroxine" - ], - "diseases": "['Hypothyroxinemia']", - "diseases_list": [ - "Hypothyroxinemia" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Birth weight: less than 1500g \n\n Gestation: 22 weeks 0 day \u2264 \n\n Serum free thyroxine level lower than 0.8 ng/dl \n\n Serum thyrotropin lower than 10 \u03bcU/ml \n\n Age of between 2 and 4 weeks after birth \n\n Informed consent \n\n ", - "exclusion_criteria": ": \n\n any known thyroid disease in mother", - "brief_summary": "In order to determine the efficacy and safety of thyroxine replacement, a randomized clinical trial of thyroxine supplementation for VLBW infant with hypothyroxinemia during the first month of age is conducted.", - "NCTID": "NCT00565890" - }, - { - "brief_title": "Chronic Sleep Deprivation as a Risk Factor for Metabolic Syndrome and Obesity", - "phase": "Phase 2", - "drugs": "['Increase sleep']", - "drugs_list": [ - "Increase sleep" - ], - "diseases": "['Obesity', 'Chronic Sleep Deprivation']", - "diseases_list": [ - "Obesity", - "Chronic Sleep Deprivation" - ], - "enrollment": "239.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 to 50 year old obese men and premenopausal women \n\n BMI between 29-55 \n\n Chronically (for more than 6 months) sleep-deprived, defined as sleeping on a regular basis less than or equal to approximately 6-1/2 hours/night by history and objective devices (wrist activity monitors and sleep logs). \n\n inclusion criteria: External comparison subjects for extension of Effectiveness Study must meet the criteria above. \n\n ", - "exclusion_criteria": ": \n\n Diagnosed sleep disorders including: \n\n Chronic insomnia \n\n Untreated sleep disordered breathing (sleep apnea at a level of severity [using standardized criteria for measurement], or diagnosed UARS [upper airway resistance syndrome] that would impair the ability to increase sleep duration [Intervention Group] or maintain sleep duration [Comparison Group]. CPAP treatment that has been in place for 3 months or more and improves sleep is acceptable). \n\n Restless leg syndrome or periodic limb movement disorder \n\n Parasomnias (including REM sleep behavior disorders, confusional arousals, sleep terrors, sleepwalking, sleep violence) \n\n Primary bruxism is allowed as long as it does not interfere with the ability to sleep an additional 90 minutes a night \n\n Narcolepsy \n\n Central apnea. \n\n Unstable weight (voluntary losses in BMI greater than 5% over the past 6 months); currently being enrolled in a weight loss program \n\n Untreated or uncontrolled diabetes \n\n Severe uncontrolled hypertension \n\n Other chronic organ disease diagnosis including: \n\n COPD \n\n Chronic cardiac arrhythmia requiring treatments \n\n Gastro-esophageal disorders associated with sleep-related symptoms. \n\n Medications \n\n chronic use of prescription or over-the-counter medications known to affect sleep (e.g., systemic steroids, NSAIDs) \n\n current anticonvulsant therapy \n\n Chronic fatigue syndrome and fibromyalgia \n\n Acromegaly, hypothyroidism (unless on a stable replacement dose of thyroid hormone), Cushing disease or other endocrine disorders known to affect sleep \n\n Poorly controlled major depression (subjects who have been on a stable pharmacological antidepressant treatment for 3 months and are in remission without substantial weight gain are eligible). \n\n Other current DSM-IV diagnoses, including: \n\n Eating disorders such as bulimia nervosa and binge eating disorder \n\n Anxiety disorders such as PTSD and panic attacks \n\n Mania \n\n Schizophrenia. \n\n Medication and substance abuse such as excessive alcohol consumption or drug abuse or dependence that may pose a threat to compliance \n\n Being a rotating worker, shift worker (working evenings or nights), or long distance commuter (more than approximately 90 minutes each way), traveling frequently outside of time zone; being in an occupation that may require special vigilance such as driving a truck, bus, or cab; operating heavy machinery; being a pilot or air traffic controller \n\n Being likely to move to a different geographical area during the study \n\n Having a sleep partner that would make compliance with study requirements difficult \n\n Pregnancy and lactation \n\n Menopause \n\n Chronic excessive caffeine use (habitual intake of more than 500 mg/day) \n\n Any condition that in the opinion of the principal investigator makes study participation and compliance problematic.", - "brief_summary": "OBJECTIVE: Obesity and chronic sleep deprivation have both become increasingly pervasive medical problems in recent years. The prevalence of adult obesity has doubled over the past 30 years and continues to increase. In addition, industrial societies attach an economic value to maximizing the waking period to the longest tolerable limit by sleeping as little as possible. Average sleep time has decreased over the last century by 2 hours. Chronically sleeping less has been associated with increased weight, endocrine and metabolic health risks including glucose intolerance, cardiovascular disease, and mortality. The possibility that the current epidemic of obesity and metabolic health risks may be partially related to insufficient sleep is now being recognized. The objective of this proof-of-concept controlled trial is to investigate the impact of increasing sleep time in chronically sleep-deprived, obese subjects.~STUDY POPULATION: 18-50 year old, obese (BMI 30-50) men and premenopausal women, chronically sleep deprived, recruited from the Baltimore-Washington metropolitan area. Chronic sleep deprivation will be verified by the use of sleep logs and the use of actigraphy before entry into the study. Secondary causes of sleep deprivation such as insomnia, psychological (depression), and medical conditions associated with poor sleep quality (including obstructive sleep apnea) will be exclusionary criteria.~DESIGN: This is a randomized, 12-month duration, comparison-controlled clinical trial of an extension of sleep up to approximately 7 hours and 30 minutes (Intervention Group) or continuation of habitual short sleep schedule (Comparison Group). The proposed treatment is an educational and behavioral intervention aimed at increasing sleep in a non-pharmacological fashion. The main analysis of the study will be to determine if additional sleep will result in a significant difference in body weight at the end of 12 months between the Intervention Group and the Comparison Group. In addition, we would like to establish whether 12 months of additional sleep will result in: a) a decreased prevalence of metabolic syndrome; and b) changes in the endocrine profile (i.e. inducing changes in leptin [increase] and ghrelin [decrease] opposite to the changes associated with chronic sleep deprivation). At the end of the 12-month intervention study (Phase 1, Efficacy Randomized Phase Study), all participants will be given information about the potential benefit of more sleep and encouraged to increase sleep time. Health teaching about proper nutrition and adequate exercise will also be provided at that time to the Intervention and Comparison Groups. All participants will be evaluated 6 months later to assess the effects of this intervention in a real-life situation, and offered participation in a three-year extension with semi-annual visits (Phase 2, Effectiveness 3 Year Follow-Up Phase Study), for which matched external comparison subjects will also be recruited ad hoc.~OUTCOME PARAMETERS: body weight, average number of hours of sleep/night, fasting glucose and insulin, oral glucose tolerance test, leptin, ghrelin, adiponectin, other relevant endocrine and anthropometric measures, body composition, various metabolic parameters, food intake, energy expenditure, and quality of life measures.", - "NCTID": "NCT00261898" - }, - { - "brief_title": "Thyroid Hormones Treatment in Asthma Exacerbation", - "phase": "", - "drugs": "['IV thyroxin', 'Placebo']", - "drugs_list": [ - "IV thyroxin", - "Placebo" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years of age or older \n\n Known Asthma \n\n The exacerbation is defined as moderate or severe. \n\n Not currently enrolled as an active participant in another clinical trial of a medical therapy or device. \n\n The patient or first degree family relative (in cases where the patient is intubated) has authorized his/her consent to participate in this trial. The patient will be asked to give his consent only after initial bronchodilator therapy \n\n ", - "exclusion_criteria": ": \n\n 60 years of age or older \n\n Known thyroid disorders \n\n Subject where thyrotoxicosis is suspected \n\n Known heart disease \n\n Heart rate > 140", - "brief_summary": "This study will explore whether supplementation with thyroid hormones in the set-up of asthma exacerbation could improve the clinical outcomes.~The study will include adults admitted to Rambam health care campus for moderate to severe Asthma exacerbation.~The study is a prospective, randomized, double-blind, placebo-controlled, clinical trial. Patients will be randomized on admission to receive treatment with intra-venous thyroxine (100mcg once on admission and additional 100mcg after 12 hours) or placebo. The study treatment will be given only after the initial bronchodilator therapy, oxygen and informed consent are given. The primary endpoint is the time to return of the peak expiratory flow (PEF) rate to normal values or personal base line.", - "NCTID": "NCT02086799" - }, - { - "brief_title": "Scalp Cooling to Prevent Chemo-induced Hair Loss", - "phase": "", - "drugs": "['PAXMAN Orbis Scalp Cooler', 'Control No treatment']", - "drugs_list": [ - "PAXMAN Orbis Scalp Cooler", - "Control No treatment" - ], - "diseases": "['Breast Cancer', 'Alopecia']", - "diseases_list": [ - "Breast Cancer", - "Alopecia" - ], - "enrollment": "236.0", - "inclusion_criteria": "inclusion criteria: \n\n New diagnosis of breast cancer stage 1-2 \n\n Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent \n\n Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline or taxane based chemotherapy regimen, \n\n Defined as one of the following regimens: - Adriamycin 60mg/m2 with cyclophosphamide 600mg/m2 - Epirubicin 90-100mg/m2 with cyclophosphamide 600mg/m2 - Doxorubicin 50mg/m2 with 5-Fluroruacil 500mg/m2 and Cyclophosphamide 500mg/m2 - Paclitaxel 80mg-90/m2 weekly (every three weeks constitute a cycle), or 175 mg/m2 every 2-3 weeks as a single agent - Docetaxel 100mg/m2 as a single agent - Docetaxel 75mg/m2-100mg/m2 with pertuzumab and traztuzumab at standard doses - Docetaxel 75mg/m2 with cyclophosphamide 600mg/m2 - Docetaxel 75mg/m2 with carboplatin AUC of 6 and trastuzumab at standard doses \n\n Concurrent traztuzumab at standard doses is allowed \n\n Concurrent pertuzumab at standard doses is allowed \n\n Administration of chemotherapy on a dose dense schedule is allowed as clinically indicated. \n\n Subjects must have TSH collected within 1 year prior to treatment and found within normal range. \n\n If patient has a history of diabetes, Hemoglobin A1c must be drawn within 3 months prior to treatment and found to be within normal limits. \n\n CBC and CMP should be done within 4 weeks prior to treatment and found to be within acceptable limits. \n\n ", - "exclusion_criteria": ": \n\n Stage 3 or 4 breast cancer or any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma) \n\n Baseline alopecia (defined CTCAE v4.0 grade > 0, see appendix B for CTCAE v4.0 scale) \n\n Subjects with cold agglutinin disease or cold urticaria \n\n Subjects who are scheduled for bone marrow ablation chemotherapy \n\n Subjects receiving chemotherapy with concurrent anthracycline and taxane (AT or TAC) \n\n Male gender \n\n Age >= 70 years", - "brief_summary": "Determine that the Orbis Paxman Hair Loss Prevention System is safe and effective in reducing chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy.", - "NCTID": "NCT01986140" - }, - { - "brief_title": "Effectiveness and Safety of Minoxidil Foam Versus Placebo Foam for Androgenetic Alopecia", - "phase": "Phase 2", - "drugs": "['Minoxidil', 'vehicle of 5% Minoxidil topical foam']", - "drugs_list": [ - "Minoxidil", - "vehicle of 5% Minoxidil topical foam" - ], - "diseases": "['Androgenetic Alopecia']", - "diseases_list": [ - "Androgenetic Alopecia" - ], - "enrollment": "70.0", - "inclusion_criteria": "inclusion criteria: \n\n Male, age 18 to 70 year old, in general good health \n\n Exhibits male AGA based on a discernable hair loss in temple and vertex region rating Hamilton-Norwood Scale III vertex to VI (See Appendix 1) \n\n Subjects who give their consent to the study after thorough explanation and who personally signed and dated the informed consent document indicating that the subject, has been informed of all pertinent aspects of the trial \n\n Willing to maintain the same hairstyle, hair length and hair color throughout the study \n\n Subjects who are willing and able to comply with scheduled visits, treatment plan, mini-tattoo and other trial procedures \n\n Accepting the Information form plus accepting and signing the Informed Consent form \n\n ", - "exclusion_criteria": ": \n\n Known to be hypersensitive to minoxidil, hair dye (p-phenylenediamine), tattoo ink, fragrances, hair gel or any vehicle components \n\n Current or 4 weeks dated back use of medical shampoos or solutions which include Ketoconazole or the like (e. g. Terzolin\u00ae) in the target region interfering with the CTM or examination method \n\n Current or 3 months dated back use of topical treatment in the target regions taken for more then 2 consecutive weeks interfering with the CTM (topical corticosteroids, aminexil, minoxidil, estrogens) \n\n Current or 3 months dated back use of systemic treatment (drugs or dietary supplement) taken for more than 2 consecutive weeks interfering with the CTM or examination method (beta blocker, cimetidine, diazoxide, isotretionin, corticosteroids, vitamin A intake above 10000 IU per day) \n\n Current or 12 months dated back use of Finasteride (Propecia\u00ae, FinaHair\u00ae, etc.), Dutasteride or a similar product \n\n Within past 12 months undergoing chemotherapy or receiving cytotoxic agents as well as radiation and/or laser/surgical therapy of the scalp \n\n Current or prior enrollment in any other investigational medication (drug) study within the 4 weeks prior to study initiation \n\n Presence of hair transplants, hair weaves or non-breathable wigs and hair bonding \n\n Current or 2 months dated back severe diet or presenting a history of eating disorder \n\n Any dermatological disorders of the scalp in the target region with the possibility of interfering with the CTM or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars or scalp atrophy \n\n Untreated persisting hypertension \n\n Active hair loss or history within the past 3 months including diffuse telogen effluvium, alopecia areata, scarring alopecia \n\n Other severe, acute or chronic medical condition that may lead to hair loss or interfere with the interpretation of trial results (e. g. untreated hypothyroidism) \n\n Individuals who are institutionalized by court or regulatory order", - "brief_summary": "The current study aims to show efficacy of twice daily application of 5% Minoxidil Topical Foam (MTF) formulation compared to placebo in the temple region of male patients with androgenetic alopecia after 24 weeks as well as to gain long-term data on the efficacy and safety of 5% MTF in male subjects with AGA in temple and vertex region, over a period of 2 years. Objective and subjective efficacy measures will be compared to baseline. Moreover, all patients will get the equal treatment and measurements in the vertex region to enable comparison of the efficacy of 5% Minoxidil Topical Foam in the temples not only to baseline but also to vertex region. Additionally safety assessments will be performed throughout the whole study.", - "NCTID": "NCT01319370" - }, - { - "brief_title": "Chromium Piccolinate in the Prevention of Weight Gain Induced by Serotonergic Medications Initiated on Psychiatric Inpatient Units.", - "phase": "Phase 2", - "drugs": "['chromium piccolinate', 'placebo for chromium piccolinate']", - "drugs_list": [ - "chromium piccolinate", - "placebo for chromium piccolinate" - ], - "diseases": "['Weight Gain', 'Obesity']", - "diseases_list": [ - "Weight Gain", - "Obesity" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Written informed consent is obtained. \n\n The subject is English-speaking and 18 through 64 years of age inclusive. \n\n The subject is currently receiving a serotonergic agent or is scheduled to receive a new or change in serotonergic psychotropic agents for their a psychiatric condition or can document that they have been on a stable regimen without any weight gain in last 3 months as a result. \n\n The subject must have capacity to obtain and give informed consent \n\n The subject must express concern about weight gain as a potential serotonin side effect. \n\n The patient is in good health as determined by a medical and psychiatric history, medical examination, and cannot have major medical illness that would jeopardize patient health during the study. \n\n Women must be of nonchildbearing potential [i.e., postmenopausal, be surgically sterile (hysterectomy or tubal ligation)] or must meet all of the following conditions: using a reliable, medically accepted form of contraception for at least 60 days before the baseline visit, and agree to continue such use throughout the duration of the study and for 30 days after the final dose of study drug. Reliable forms of contraception include oral, implanted, or injected contraceptives; intrauterine devices in place for at least 3 months; and adequate double-barrier methods in conjunction with spermicide (abstinence is considered an acceptable contraceptive regimen). \n\n Women must be given a urine pregnancy test (\u00dfHCG), unless they are at least 2 years postmenopausal or surgically sterile, and the results of the test must be negative. \n\n The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol. \n\n The patient must be a voluntary admission inpatient at SUNY Upstate Medical University's Psychiatric department in order to enroll in the study. \n\n ", - "exclusion_criteria": ": \n\n The patient lacks capacity to make medical decisions and ability to receive and utilize the informed consent process due to their mental illness. \n\n The patient is incapacitated by mental illness \n\n The patient is a significant risk of suicide as determined by the study team in this acute setting \n\n The patient has recently started a weight loss or exercise program or is taking an insulin resistance improving drug OR plans to start one upon discharge \n\n The patient has a co-morbid medical problem thought to induce weight gain or make it difficult to lose weight (ie hypothyroid, hypercortisol, diabetes\u2026) \n\n The patient has previously ( in the last 2 months) lost or gained a significant amount of weight from any weight loss program, weight loss agent, or dietary medication. \n\n The patient has used an investigational drug within 1 month before the screening visit or is participating in a concurrent clinical trial. \n\n The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery). \n\n The patient is highly unlikely to comply with the study protocol, be unreliable in providing ratings, or is unsuitable for any reason, as judged by the investigator. \n\n The patient has a clinically significant deviation from normal in the physical examination or medical history (renal or hepatic problems) which makes subject medically unstable at time of screening. \n\n The subject can not be currently on any medication that is clearly being used to lower weight. Examples include: Xenical, Metformin, Wellbutrin, Topomax, psycho-stimulants, and Moban.", - "brief_summary": "A majority of patients who suffer from mental illness are treated with serotonin regulating FDA approved medications. Some of these medications also block histamine transmission, increase blood prolactin levels, induce insulin resistance, hyperlipidemia, and promote sedation. All of which lead to weight gain and obesity. Many of these drugs are generally safe and effective but do carry the risk of a long term side effect in that acute and gradual weight gain of 10-30 pounds over a few months to a year of treatment. The detrimental gain of 7% of pre-drug weight is reported with many antipsychotics, mood stabilizers and some antidepressants. This weight gain may subsequently add to medical co-morbidity ( ie diabetes, hypertension, osteoarthritis, coronary artery diseasem, hyperlipidemia\u2026 ) This therapeutic manipulation of brain serotonin functioning may be associated with abnormal increases in carbohydrate cravings, consumption and weight gain. It is possible that insulin resistance occurs as a direct effect or as an indirect effect of weight gain, particularly in patients prone to weight gain or diabetes due to genetic loading. Leptin, a chemical associated with feedback signaling that reduces appetite and adipose tissue growth may also become insensitive. These multiple insults may lead to the worst weight gain in patients taking clozapine, olanzapine, and mirtazapine.~Diet and exercise and lifestyle modification are the usual initial interventions, though being depressed, anxious, bipolar, or schizophrenic often interferes with the ability to make these changes. In fact most of the studies which look at these weight loss interventions occur in patients who are institutionalized, on restricted diets and may respond to token economy systems while on longer term inpatient unit stays. This token economy approach is not easily translated to usual outpatient or short term inpatient practice settings. In these settings, if lifestyle modification approaches fail, patients may be placed on FDA approved diet medications (sibutramine, orlistat, ionamin\u2026) which carry significant side effect risks. Some patients are even placed on the epilepsy medications such as zonisamide or topiramate at an even greater side effect risk.~In a similar weight gain prone group, there is growing literature in the diabetes population that the use of high dose chromium improves (lowers) insulin resistance by way of increasing insulin binding to cells, receptor numbers, and insulin receptor kinase activity. Lower fasting blood glucose levels in the blood generally occurs. Some reports show a reduction in blood lipid/cholesterol levels at higher chromium dosing as well. Recently, chromium piccolinate was studied in depressed patients, especially those with atypical features (usually fatigue, weight gain, carbohydrate cravings). Although there was no change in depression symptoms overall, carbohydrate cravings improved. This paper was presented at the 2005 American Psychiatric Association Annual Meeting in Atlanta. As a foil, a few papers in non-diabetics,non-depressed healthy volunteers showed little to no effectiveness in lowering blood sugar levels. Furthermore, one investigator (JLM) has published data showing acute , clinically significant weightgain in serotonergically treated psychiatric inpatients. The authors theorize that the use of chromium may reduce carbohydrate craving, appetite and thus protect against weight gain side effects.~Given this pivotal paper in the depressed population, effectiveness data in the diabetes population and some possible metabolic ties between these two populations, the author wishes to study the effect of chromium piccolinate in mentally ill subjects who are being started on serotonergic manipulating medications while in an inpatient treatment setting. These patients will be followed during their inpatient stay and then be followed after discharge for a single visit to determine acute interventional effects of chromium piccolinate. We feel chromium piccolinate is less toxic/hazardous than many of the weght loss medications that we currently use and therefore suggest a long term randomized, controlled study where subjects will receive active drug (chromium piccolinate) or placebo at the start of any serotonergic treatment while inpatient. The chromium piccolinate and the placbo will be obtained from the Nutrition 21 company, which has been approved by the FDA as a source of this product.", - "NCTID": "NCT00759993" - }, - { - "brief_title": "The Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia", - "phase": "Phase 4", - "drugs": "['CBT-I', 'modafinil']", - "drugs_list": [ - "CBT-I", - "modafinil" - ], - "diseases": "['Primary Insomnia']", - "diseases_list": [ - "Primary Insomnia" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n 40 patients aged 25 with insomnia, will be recruited over a 3-6 month interval. \n\n All subjects will have a stable sleep/wake schedule with a preferred sleep phase between 10:00 PM and 8:00 AM. \n\n Must live in the Greater Rochester NY area \n\n All subjects will meet diagnostic criteria for Psychophysiological Insomnia according to the International Classification of Sleep Disorders (ICSD). Criteria are: the complaint of insomnia and impaired daytime function; an indication of learned sleep-preventing associations and somatized tension; active help seeking. The complaint of disturbed sleep will have one or more of the following characteristics: >30 minutes to fall asleep and/or >2 awakenings per night of >15 minutes duration and/or wake after sleep onset time of > 30 minutes, problem frequency >4 nights/ week, and problem duration >6 months. In addition, all subjects will complain of fatigue and/or sleepiness at intake. \n\n ", - "exclusion_criteria": ": \n\n As above", - "brief_summary": "This study examines how treatment with the drug modafinil, by itself or in combination with cognitive behavioral treatment for insomnia (CBT-I), may improve daytime functioning and/or diminish the severity of insomnia.", - "NCTID": "NCT00124384" - }, - { - "brief_title": "Comparison of Biomarkers of Stress in Emergency Physicians Working a 24-hour Shift or a 14-hour Night Shift - the JOBSTRESS Randomized Trial", - "phase": "", - "drugs": "['Comparison of biomarkers of stress']", - "drugs_list": [ - "Comparison of biomarkers of stress" - ], - "diseases": "['Biomarkers of Stress in Emergency Physicians']", - "diseases_list": [ - "Biomarkers of Stress in Emergency Physicians" - ], - "enrollment": "19.0", - "inclusion_criteria": "inclusion criteria: \n\n emergency physician \n\n ", - "exclusion_criteria": ": \n\n endocrine disease, pregnancy, recent extraprofessional deleterious life event (such as death of a near relative, divorce), any current illness, drugs used to modulate inflammatory diseases (corticosteroids, anti-inflammatory drugs, immunomodulatory drugs), or any drugs with a chronotropic effect taken over the previous six months (beta blockers, diltiazem, verapamil, anxiolytics or antidepressants).", - "brief_summary": "A stressful state can lead to symptoms of mental exhaustion, physical fatigue, medical errors, and also increase coronary heart disease. Emergency physicians subjectively complain of stress related to changes in work shifts. Several potential biomarkers of stress have been described, but never investigated in emergency physician, who may represent a good model of stress due to the complex interplay between stress (life-and-death emergencies, which is the defining characteristic of their job), lack of sleep and fatigue due to repeated changes in shifts.The aim of this study was to compare biomarkers in emergency physicians working a 24-hour shift (24hS) or a 14-hour night shift (14hS), and in those working a control day (clerical work on return from leave). We also followed these markers three days following each shift (D3/24hS and D3/14hS).", - "NCTID": "NCT01874704" - }, - { - "brief_title": "Effects of a Novel Dietary Intervention on Body Composition After Laparoscopic Gastric Bypass Surgery", - "phase": "", - "drugs": "['BariatrX Essentials 360 Treatment']", - "drugs_list": [ - "BariatrX Essentials 360 Treatment" - ], - "diseases": "['Obesity', 'Morbid Obesity']", - "diseases_list": [ - "Obesity", - "Morbid Obesity" - ], - "enrollment": "7.0", - "inclusion_criteria": "inclusion criteria: \n\n Obese and morbidly obese women (BMI 30 - 50) \n\n 25 years and older undergoing laparoscopic gastric bypass surgery \n\n Present with at least either metabolic syndrome or diabetes \n\n ", - "exclusion_criteria": ": \n\n Have smoked in the past 4 weeks \n\n Pregnant \n\n Allergic or intolerant to ingredients used in the study (e.g. soy and THIAA) \n\n There is a sound medical, psychiatric and/or social reason as determined by the Principal Investigator (PI) that makes the subject unsuitable for the study", - "brief_summary": "We propose to compare the standard of care with the use of a novel medical food in 6 bariatric surgery patients by measuring outcomes of body composition, quality of life, hair loss, muscle strength, resting energy expenditure, and biochemical parameters.", - "NCTID": "NCT01041261" - }, - { - "brief_title": "Hairstetics\u2122 Anchoring System in Female Pattern Hair Loss (HAS-FPHL)", - "phase": "", - "drugs": "['Hairstetics\u2122 anchoring system']", - "drugs_list": [ - "Hairstetics\u2122 anchoring system" - ], - "diseases": "['Female Pattern Baldness', 'Alopecia, Androgenetic']", - "diseases_list": [ - "Female Pattern Baldness", - "Alopecia", - "Androgenetic" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 19 yrs. \n\n Female patients with androgenetic alopecia (FPHL). \n\n Pre-treatment hematology and coagulation values within the limits: \n\n Hemoglobin \u2265 10 g/dl (g/100 ml) \n\n Platelets \u2265 150 x 10^9/L (10^3/mm^3) \n\n WBC \u2265 3.0 x 10^9/L (10^3/mm^3) \n\n INR 0.8 - 1.2 --- \n\n PTT 25 - 35 \n\n Serum creatinine < 2 mg/dl \n\n SGOT < 1.5 x ULN (Upper Limit of Norm) \n\n SGPT < 1.5 x ULN \n\n Alkaline phosphatase < 1.5 x ULN \n\n A life expectancy at least of the duration of the trial. \n\n Signed informed consent and post-implantation protocol. \n\n ", - "exclusion_criteria": ": \n\n Prosthetic hair implantation or hair transplantation in the 6 months preceding enrollment to this study. \n\n Skin conditions that might affect the procedure and/or its outcome. NOTE: Such conditions are not necessarily restricted to or involve the prospective implantation site and/or its vicinity. \n\n Patients currently receiving, or that have received within the past 3 months, radio- and/or chemotherapy. \n\n Patients on anticoagulant treatment. \n\n More than a maintenance dose of oral corticosteroids (maintenance dose is defined as the same dose regimen over the past 6 months for a condition requiring continual corticosteroid treatment) or patients with an immunocompromised state for any reason. \n\n Bleeding disorder. \n\n Patient presenting with a health condition that may affect compliance with the study protocol, either by itself or combined with other conditions present in the patient. \n\n Use of illegal substances. \n\n Participation in another interventional study, unless discussed with and approved by the Sponsor or Sponsor's authorized representative. \n\n Quantitative \u03b2-HCG \u2265 5 mIU/mL (IU/L) in women of childbearing potential. \n\n Lactating and/or breastfeeding women. \n\n Known hypersensitivity (e.g., to nitinol, nickel or titanium) or adverse event that would prevent a prospective study participant from being administered the trial treatment or non-investigational medicinal product(s), as detailed in the protocol. \n\n Patients with implanted electronic devices (such as cardiac pacemakers) unless they receive permission from their treating physician (e.g., cardiologist) and are monitored by a treating physician during the treatment session.", - "brief_summary": "The aim of the study is to provide evidence of safety and preliminary performance of the Hairstetics\u2122 anchoring system in female subjects affected with androgenetic alopecia (female pattern hair loss; (FPHL)).~The study will also help to determine whether the Hairstetics\u2122 anchoring system, in conjunction with attachment of hair extensions, is efficacious in improving patient and physician aesthetic satisfaction with the treated scalp appearance in female patients with androgenetic alopecia.", - "NCTID": "NCT02316418" - }, - { - "brief_title": "Pregabalin in the Treatment of Essential Tremor", - "phase": "Phase 1", - "drugs": "['pregabalin (Lyrica)', 'placebo']", - "drugs_list": [ - "pregabalin (Lyrica)", - "placebo" - ], - "diseases": "['Essential Tremor']", - "diseases_list": [ - "Essential Tremor" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects must be between the ages of 18 and 80 inclusive. \n\n Each subject must have current manifestations of ET symptoms based on the Tremor Investigational Group (TRIG) criteria for definite or probable ET: - Moderate or severe tremor in head or arms for at least 3 years duration. - No present causes of enhanced physiologic tremor. - No recent exposure to tremorogenic drugs or drug withdrawal states. - No direct or indirect trauma to the nervous system within 3 months preceding the onset of tremor. - No historic or clinical evidence of psychogenic tremor origin. \n\n Subjects with a history of seizures are eligible. \n\n Subjects must be in generally good health as evidenced by previous medical history and clinical examination. \n\n Patients will be allowed to take Beta-blockers but will not be allowed to take any other medication for tremor (primidone, topiramate, benzodiazepines, etc.) An evening dose of a benzodiazepine to improve sleep is acceptable. They must have been on a stable dose of any existing beta-blocker for 4 weeks prior to entry into the study and will not be allowed to change the dose of that medication throughout the controlled portion of the study. Any medication discontinued during screening in order to comply with these criteria must be stopped for 5 half-lives prior to study initiation. \n\n Subjects must be accessible by telephone. \n\n If the subject is a female of childbearing age, she must have had a hysterectomy, tubal ligation, otherwise be incapable of pregnancy, or have practiced one of the following methods of contraception for at least one month prior to study entry (or a negative urine pregnancy test within one week of study entry): - Hormonal contraceptives - Spermicide and barrier - Intrauterine device - Partner sterility \n\n Prior to participation in this study, each subject must sign an informed consent. \n\n ", - "exclusion_criteria": ": \n\n Patients do not meet TRIG criteria for probable ET. \n\n Subjects who are not able to abstain from alcohol for 24 hours prior to each evaluation. \n\n Patients who can not maintain an identical dose of any medicine that may affect tremor during their entire study involvement. \n\n Subjects who have exhibited any psychotic symptomatology. \n\n Subjects who have known renal deficiencies. \n\n Subjects who have been intolerant of pregabalin in the past \n\n Prior surgical treatment for tremor. \n\n Patients currently taking more than a single drug for ET. \n\n Patients taking anti-seizure medications. \n\n Breast feeding or pregnant females.", - "brief_summary": "Pregabalin is approved for the treatment of nerve pain as well as an additional therapy in the treatment of seizures. In December 2004, Pfizer gained Food and Drug Administration (FDA) approval for use of pregabalin in nerve pain associated with diabetes and shingles; making it the first FDA-approved treatment for both of these nerve pain states.~Tremor is uncontrolled trembling in part of the body. Essential tremor (ET) is associated with purposeful movement(e.g., holding a glass to drink, shaving, writing and buttoning a shirt). It occurs most often in the hands and head and also may affect the arms, voice box (larynx), trunk, and legs. ET is caused by abnormalities in areas of the brain that control movement. It usually does not result in serious complications.~ET affects approximately 5 million people in the United States. Incidence is highest in people over the age of 60.~ET usually develops gradually during middle age or later in life. Symptoms may remain mild or become more severe over time. Stress, fatigue, anxiety, and hot or cold weather can worsen the disorder. Severe tremor may cause difficulty doing activities of daily living, such as:~Brushing hair and teeth~Holding a glass without spilling~Performing self-care (e.g., getting dressed, shaving, putting on makeup)~Using eating utensils~Writing and drawing~The purpose of this pilot/feasibility study is to examine the tolerability and efficacy of Pregabalin in patients with ET.~In other words, can patients diagnosed with ET tolerate high dose of pregabalin? Will the pregabalin be considered as an efficient medicine in the treatment of ET?", - "NCTID": "NCT00646451" - }, - { - "brief_title": "A Study to Compare Two Ways of Completing Pain and Sleep Questions and to Evaluate a New Daily Questionaire for Assessing Fatigue in Fibromyalgia Patients", - "phase": "", - "drugs": "['Interactive Voice Response System (IVRS)', 'Personal Digital Assisstant (PDA)']", - "drugs_list": [ - "Interactive Voice Response System (IVRS)", - "Personal Digital Assisstant (PDA)" - ], - "diseases": "['Fibromyalgia']", - "diseases_list": [ - "Fibromyalgia" - ], - "enrollment": "185.0", - "inclusion_criteria": "inclusion criteria: \n\n Fibromyalgia using ACR diagnosis \n\n ", - "exclusion_criteria": ": \n\n Other confounding disease including other inflammatory disease, pain and depression", - "brief_summary": "The study has two goals. The first goal of the study is to compare two methods of administering questions about pain and sleep interference. The two methods being compared are a telephone based system and an electronic hand held diary. The second goal of the study is to evaluate a daily diary to evaluate fatigue symptoms in patients with fibromyalgia.", - "NCTID": "NCT00819624" - }, - { - "brief_title": "Prevention of Weight Gain", - "phase": "", - "drugs": "['Weight Gain Prevention for Women Project']", - "drugs_list": [ - "Weight Gain Prevention for Women Project" - ], - "diseases": "['Obesity', 'Body Weight Changes']", - "diseases_list": [ - "Obesity", - "Body Weight Changes" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Body mass index of 21 through 30 \n\n ", - "exclusion_criteria": ": \n\n Presence of chronic disease that precludes regular physical activity or changes in dietary intake \n\n Currently receiving treatment for psychological disorder \n\n Currently pregnant or having given birth within last 12 months \n\n Use in last 3 months of weight loss medications or other drugs that affect body weight \n\n Participation in a weight loss program in last 12 months \n\n Planning to relocate outside the study area in the next 3 years", - "brief_summary": "The purpose of this study is to test methods for preventing weight gain in normal-weight and overweight women aged 25 through 44. Participants will complete brief questionnaires about their health, eating and exercise habits, and use of weight control strategies. They will then be randomly assigned to 1 of 3 treatment conditions. All 3 treatments receive information on the importance of maintaining a healthy body weight, the components of a healthy diet, and ways to increase activity levels. The 3 treatment differ in how this information is delivered. At 12, 24 and 36 months after enrolling in the study, participants will attend assessment sessions. They will complete questionnaires and have body weight measured.", - "NCTID": "NCT00011102" - }, - { - "brief_title": "Sleep and Immunity in Rheumatoid Arthritis : Remicade Substudy", - "phase": "", - "drugs": "['Remicade']", - "drugs_list": [ - "Remicade" - ], - "diseases": "['Rheumatoid Arthritis']", - "diseases_list": [ - "Rheumatoid Arthritis" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Rheumatoid arthritis patients will meet American College of Rheumatology revised criteria (Arnett, Edworthy et al. 1988). This requires at least four of the following seven criteria: 1) morning joint stiffness; 2) arthritis in 3 or more joint areas; 3) arthritis of hand joints; 4) symmetric arthritis; 5) rheumatoid nodules; 6) presence of serum rheumatoid factor and 7) changes on posteroanterior hand and wrist radiographs. In addition, criteria 1-4 must be present for at least four weeks. Subjects must be between 18 and 85 years of age. \n\n If rheumatoid arthritis patients are receiving treatment with traditional disease modifying antirheumatic drugs (DMARD), such as methotrexate, sulfasalazine or hydroxychloroquine, they must be on a stable regime for one month before study and stable throughout study. \n\n If rheumatoid arthritis patients have received treatment with a TNF antagonist or other biologic medication, they must be drug free for greater than 3 months. \n\n ", - "exclusion_criteria": ": \n\n Steroids - Individuals currently taking greater than an equivalent of 10 mg of prednisone will be excluded given the potent anti-inflammatory effects of such medications. \n\n Opioids - Individuals using multiple daily dosage schedule of opioid agents such as oxycodone (Percocet), hydrocodone (Vicodin), morphine, Dilaudid will be excluded. \n\n Co-morbid medical disorders - the presence of active unstable and uncontrolled co-morbid medical conditions such as diabetes, cardiovascular diseases, and cancer will be exclusionary criteria. In particular, individuals with co-morbid inflammatory disorders such as Crohn's disease and ulcerative colitis and other autoimmune disorders will be excluded. Any uncontrolled medical condition that is deemed by the investigators to interfere with the proposed study procedures, or put the study participant at undue risk will also be considered exclusionary criteria. \n\n Chronic infections - individuals with chronic infections will also be excluded because of effects on immune markers measured in study. \n\n Co-morbid pain disorders - individuals with co-morbid pain disorders such as fibromyalgia will also be excluded. Individuals with fibromyalgia have been found to have sleep abnormalities as well as daytime fatigue and pain and thus could confound findings. \n\n Psychiatric disorders - current conditions such as major depressive disorder, bipolar disorder and risk for suicide will also be considered exclusionary criteria. \n\n Gender-based criteria - pregnant or breast-feeding women will also be excluded because of their effects on neuroendocrine systems and sleep", - "brief_summary": "More than half of rheumatoid arthritis (RA) patients complain of sleep disturbance and this cardinal complaint is associated with fatigue, pain, and depressed mood in patient with chronic inflammatory disorder. Despite the frequency of this complaint, there is limited efforts to evaluate sleep or the abnormal increases in the expression of pro-inflammatory cytokines play a key role in the progression of RA, we hypothesize that the cytokine network is one physiological system that is associated with sleep disturbances in RA patients. Pro-inflammatory cytokines signal the central nervous system and are associated with increased symptoms of pain, fatigue, and depressed mood in rheumatic patients. The specific aims of the study are to examine the contribution of cytokines on sleep by administering a TNF antagonist vs. placebo to probe the action of pro-inflammatory cytokines on sleep in RA Patients. Examination of sleep and its consequences for pro-inflammatory cytokine activity within the framework of an observational and experimental research design will have implications for understanding the psycho-biological mechanisms that link sleep and the clinical manifestations of RA. Results from this study will guide the developments of interventions that target disordered sleep with potential effects on disability in RA.", - "NCTID": "NCT00948610" - }, - { - "brief_title": "Trastuzumab & Pertuzumab Followed by T-DM1 in MBC", - "phase": "Phase 2", - "drugs": "['Trastuzumab', 'Pertuzumab', 'Paclitaxel', 'Vinorelbine', 'T-DM1']", - "drugs_list": [ - "Trastuzumab", - "Pertuzumab", - "Paclitaxel", - "Vinorelbine", - "T-DM1" - ], - "diseases": "['Metastatic Breast Cancer']", - "diseases_list": [ - "Metastatic Breast Cancer" - ], - "enrollment": "208.0", - "inclusion_criteria": "SELECTION OF PATIENTS (MOST IMPORTANT CRITERIA) \n\n inclusion criteria for first-line therapy \n\n \u2022 Histologically confirmed breast cancer with distant metastases \n\n Note: \n\n A biopsy from the primary tumor or a metastasis can be used for diagnosis. \n\n Patients with non-measurable lesions are eligible. \n\n Patients with inoperable, locally advanced breast cancer with lymph node metastases other than ipsilateral locoregional (axillary, infraclavicular, parasternal) or other distant metastases are eligible. \n\n Patients with bone metastases with or without bone targeted therapy (bisphosphonates, denosumab) are eligible. \n\n Patients with de-novo Stage IV disease are eligible. \n\n HER2-positive tumor according to central pathology testing for HER2 \n\n Note: \n\n A formalin-fixed paraffin-embedded (FFPE) biopsy from the primary tumor or a metastasis has to be used for HER2 status determination. If a biopsy is available from a metastasis, the HER2 testing should be performed using the metastasis. \n\n Fine needle aspiration is not acceptable for HER 2 testing. \u2022 Women aged \u226518 years \n\n \u2022 WHO performance status 0 to 2 \n\n Left Ventricular Ejection Fraction (LVEF) \u226550% as determined by either ECHO or MUGA \n\n Adequate organ function, evidenced by the following laboratory results: \n\n Neutrophils >1.5x109/L, platelets >100x109/L, hemoglobin \u226590g/L, total bilirubin \u22641.5xULN (unless the patients has documented Gilbert's disease), AST \u22643xULN, ALT \u22643xULN, AP \u22642.5xULN (except in patients with bone metastases: AP \u22645xULN), creatinine \u22641.5xULN \n\n ", - "exclusion_criteria": " for first-line therapy \n\n \u2022 Prior chemotherapy for inoperable locally advanced or metastatic breast cancer \n\n Note: \n\n Prior neoadjuvant/adjuvant chemotherapy is allowed if doses for anthracyclines have not exceeded 720mg/m2 and 240mg/m2 for epirubicin and doxorubicin, respectively. \n\n - Re-exposure to paclitaxel is permitted, if the last dose of taxane was given at least 1 year before randomization. \n\n - Re-exposure to vinorelbine is permitted, if the last dose of vinorelbine was given at least 1 year before randomization. \n\n Prior anti-HER2 treatment for metastatic or inoperable breast cancer \n\n Note: \n\n Prior neoadjuvant/adjuvant anti-HER2 treatment with trastuzumab and/or lapatinib is allowed. \n\n \u2022 More than one endocrine treatment line for metastatic or inoperable breast cancer exceeding a duration of 1 month \n\n Note: \n\n Adjuvant endocrine treatment is not counted as one line. \n\n Patients progressing on endocrine treatment: this specific endocrine treatment must have been stopped at least 2 weeks prior to randomization. \n\n \u2022 Prior treatment with pertuzumab and/or T-DM1 \n\n \u2022 Known leptomeningeal or CNS metastases \n\n Note: \n\n A brain MRI or CT scan is mandatory in case of clinical suspicion of CNS metastases. \n\n \u2022 Single bone metastasis treated with radiotherapy (if the bone metastasis is the only tumor lesion) \n\n inclusion criteria for second-line therapy \u2022 At least one dose of trial therapy in the first-line treatment phase of this trial \n\n \u2022 \u2022 Proven disease progression on first-line therapy or radiotherapy of a bone metastasis \n\n Notes: \n\n First new parenchymal CNS metastases only do not count as progression requiring the initiation of second line trial treatment. Radiotherapy of a single area only for pain control is allowed and will not count as PD. \n\n \u2022 Adequate organ function, evidenced by the following laboratory results: Neutrophils >1.5x109/L, platelets >100x109/L, hemoglobin \u226590g/L, total bilirubin \u22641.5xULN (unless the patients has documented Gilbert's disease), AST \u22643xULN, AP \u22642.5xULN (except in patients with bone metastases: AP \u22645xULN), creatinine \u22641.5ULN \n\n \u2022 LVEF \u226550% as determined by either ECHO or MUGA \n\n \u2022 QoL questionnaire has been completed. \n\n ", - "brief_summary": "In HER2-positive metastatic breast cancer, trastuzumab based treatment is the standard of care as long as there are no contraindications to trastuzumab. Frequently, trastuzumab is being combined with taxanes in the first-line setting. However, since therapy with trastuzumab is active even in the absence of chemotherapy in HER2-positive MBC, the optimal treatment strategy either in combination or in sequence with chemotherapy is still under debate. This randomized phase II trial is studying a new strategy for the treatment of metastatic breast cancer with HER2-positive. First-line treatment consists of trastuzumab and pertuzumab, a treatment without chemotherapy. In case of disease progression, chemotherapy with T-DM1 is then performed as second-line treatment. Third-line and further line therapies are performed according to the physician's discretion. If this new therapeutic strategy is as effective and better tolerated than the conventional strategy, this would mean a serious breakthrough in the treatment of HER2-positive metastatic breast cancer.", - "NCTID": "NCT01835236" - }, - { - "brief_title": "Overnight Weight Loss and Sleep Structure", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Obesity', 'Healthy']", - "diseases_list": [ - "Obesity", - "Healthy" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n normal and obese volunteers \n\n ", - "exclusion_criteria": ": \n\n serious medical or neurological condition", - "brief_summary": "The objectives of the present study are:~to evaluate if overnight weight loss is dependent on sleep structure assessed by polysomnography;~to compare weight loss rate during sleep and awake rest;~to compare night weight loss profile of normal and obese volunteers.", - "NCTID": "NCT00915642" - }, - { - "brief_title": "Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome", - "phase": "Phase 2", - "drugs": "['Ramelteon', 'Ramelteon', 'Ramelteon', 'Placebo']", - "drugs_list": [ - "Ramelteon", - "Ramelteon", - "Ramelteon", - "Placebo" - ], - "diseases": "['Sleep Disorders, Circadian Rhythm']", - "diseases_list": [ - "Sleep Disorders", - "Circadian Rhythm" - ], - "enrollment": "132.0", - "inclusion_criteria": "inclusion criteria: \n\n Females of childbearing potential who is sexually active must agree to use adequate contraception from screening throughout the duration of the study. \n\n Must have a diagnosis of Delayed Sleep Phase Syndrome according to International Classification of Sleep Disorders criteria for at least 3 months. \n\n Based on sleep history, subject's habitual sleep time is more than 3 hours later than the desired sleep time. \n\n Must have had self reported insomnia which is defined per the sleep history as his or her sleep latency of at least 45 minutes when attempting to sleep at desired sleep time required by his or her work or school schedule. \n\n The subjective sleep latency via Post sleep questionnaire during outpatient screening period must be greater than or equal to 45 minutes during every working night or school night provided the subject went to bed at their desired sleep time. \n\n During single blind placebo run-in Polysomnography screening nights, subject is instructed to go to bed at their desired bed time and must demonstrate difficulty in falling asleep based on the following criteria: \n\n During Polysomnography screening nights when the subject goes to bed at their desired sleep time or \n\n The average of total wake time \n\n Is in good health as determined by a medical and psychiatric history, physical examination, Electrocardiogram, and serum chemistry and hematology. \n\n Is able to complete self-rating scales via interactive voice response system, and has a touch tone phone. \n\n Is willing to comply with study procedures and restrictions with fixed sleep time and wake time during the study and to attend regularly scheduled clinic visits as specified in this protocol. \n\n Has a body mass index is between 18 and 34 kg/m2, inclusive. \n\n Has a negative urine test result for selected substances of abuse (including alcohol). \n\n Has a negative test result for hepatitis B surface antigen and hepatitis C virus antibody or history of human immunodeficiency virus. \n\n Has not used pharmacological sleep assistance for more than 4 times/week during the 3 months prior to Initial Screening. \n\n Must have discontinued use of all pharmacological sleep aids beginning 1 week prior to Visit 2 and for the duration of the trial. \n\n ", - "exclusion_criteria": ": \n\n Has a known hypersensitivity to ramelteon or related compounds, including melatonin and melatonin-related compounds or 5-hydroxytryptophan. \n\n Has participated in any other investigational study and/or taken any investigational drug within 30 days or 5 half-lives prior to the first dose of study medication, whichever is longer. \n\n Has flown across greater than 3 time zones within the past 3 months prior to administration of study medication. \n\n Has sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the administration of study medication. \n\n Has participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the administration of study medication. \n\n Has a history of alcohol abuse within the past 12 months, as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, or regularly consumes more than 14 alcoholic drinks per week or consumes any alcoholic drinks within 24 hours of Screening Visit. \n\n Has a history of drug abuse within the past 12 months. \n\n Has a current, clinically significant neurological (including cognitive), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, as determined by the investigator. \n\n Has a probable current diagnosis of another circadian rhythm disorder or a sleep disorder other than Delayed Sleep Phase Syndrome that is the primary cause of insomnia. \n\n Had an apnea hypopnea index greater than 10 on the first night of Polysomnography Screening. \n\n Has periodic limb movements during sleep with arousal index greater than 10 as seen on the first night of Polysomnography screening only. \n\n Has a positive urine drug screen or breathalyzer test. \n\n Has ever had a history of seizures; sleep apnea, restless leg syndrome, chronic obstructive pulmonary disease, fibromyalgia, or a positive test result for the aforementioned ailments on the screening Polysomnography, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder. \n\n Has a history of psychiatric disorder (including anxiety or depression) within the past 12 months. \n\n Smokes more than 3 cigarettes per day or uses tobacco products during nightly awakenings. \n\n Routinely consumes caffeine including coffee, tea and/or other caffeine-containing beverages or food averaging more than 600 mg of caffeine per day. \n\n Has used any central nervous system drug or other medications, including those used to treat psychiatric disorders, known to affect sleep/wake function within 1 week whichever is longer prior to the administration of single blind study drug. \n\n Used melatonin, or other drugs/supplements known to affect sleep/wake function within 1 week (or 5 half lives of the drug) whichever is longer prior to the first dose of single blind medication. \n\n Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including: \n\n Anxiolytics \n\n Hypnotics \n\n Antidepressants \n\n Anticonvulsants \n\n Sedating H1 antihistamines \n\n Systemic steroids \n\n Respiratory stimulants \n\n Decongestants \n\n Antipsychotics \n\n Muscle relaxants \n\n Over-the-counter and prescription diet aids \n\n Narcotic analgesics \n\n Beta Blockers \n\n St. John's wort \n\n Kava kava \n\n Ginkgo biloba \n\n Modafinil \n\n Coumadin \n\n Heparin \n\n Melatonin and all other drugs or supplements known to affect sleep/wake function will be prohibited within 1 week of the first dose of study medication and during the entire study. \n\n Has any clinically important abnormal finding as determined by a medical history, physical examination, Electrocardiogram, or clinical laboratory tests as determined by the investigator. \n\n Has a positive hepatitis panel including anti- Hepatitis A Virus, hepatitis B surface antigen or anti- hepatitis C virus. \n\n Has any additional condition(s) that in the investigator's opinion would: \n\n Affect sleep/wake function \n\n Prohibit the subject from completing the study, or \n\n Not be in the best interest of the subject. \n\n Exhibits a placebo response during single-blinded placebo run in period. \n\n Individuals with a habitual sleep time later than 4:00 am should not be included in the study.", - "brief_summary": "The purpose of this study is to evaluate the ability of ramelteon, once daily (QD), to advance the timing of sleep in individuals with delayed sleep phase syndrome.", - "NCTID": "NCT00593736" - }, - { - "brief_title": "Physical Activity for Advanced Stage Cancer Patients", - "phase": "", - "drugs": "['Six Week Physical Activity Intervention', 'Progress Reporting']", - "drugs_list": [ - "Six Week Physical Activity Intervention", - "Progress Reporting" - ], - "diseases": "['Cancer']", - "diseases_list": [ - "Cancer" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n have stage III or IV cancer diagnosis \n\n able to understand English \n\n have a Karnofsky Performance Status (KPS) score of 60% (able to care for most of the personal needs) \n\n have fatigue and/or two other target symptoms \n\n have been cleared by their provider to engage low to moderate intensity physical activities \n\n ", - "exclusion_criteria": ": \n\n are hospitalized \n\n have lesion or metastasis of bone \n\n have a cardiac pacemaker \n\n have a history of seizure or loss of consciousness \n\n have been using a Wii Fit \n\n diagnosed cognitive impairment", - "brief_summary": "The purpose of this study is to understand if a home-based physical activity program can improve symptoms and physical function among patients with advanced stage cancer.", - "NCTID": "NCT02015936" - } - ], - "1": [ - { - "brief_title": "Phase 4 Study in Secondary Hypothyroidism: Body Weight Adapted Thyroxin Treatment and Triiodothyronine Supplementation", - "phase": "Phase 4", - "drugs": "['Thyroxin, Triiodothyronine']", - "drugs_list": [ - "Thyroxin", - "Triiodothyronine" - ], - "diseases": "['Secondary Hypothyroidism', 'Hypopituitarism', 'Hyperlipidemias']", - "diseases_list": [ - "Secondary Hypothyroidism", - "Hypopituitarism", - "Hyperlipidemias" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n hypopituitarism of at least 3 axes (TSH plus gonadotropin, somatotropin, corticotropin or ADH deficiency) \n\n termination of surgical or radiation treatment of pituitary tumors at least six month before study entry \n\n BMI of 20 - 39.9 kg/m2 \n\n non-smoking status. \n\n ", - "exclusion_criteria": ": \n\n history of cardiovascular or pulmonary diseases \n\n current thyroxin dosage > 1.6 \u00b5g/kg bw \n\n pregnancy \n\n epilepsy \n\n cerebrovascular diseases \n\n nodular goiter", - "brief_summary": "The purpose of this study is to determine whether a body weight adjusted dose of thyroxin is superior to treatment guided by laboratory results of thyroxin hormones in patients with central hypothyroidism. Moreover beneficial effects of triiodthyronine supplementation are investigated.", - "NCTID": "NCT00360074" - }, - { - "brief_title": "DNA Methylation and Autoimmune Thyroid Diseases", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Hashimoto Thyroiditis', 'Graves Disease']", - "diseases_list": [ - "Hashimoto Thyroiditis", - "Graves Disease" - ], - "enrollment": "110.0", - "inclusion_criteria": "inclusion criteria: \n\n For HT: \n\n A positive titers of antithyroid peroxidase (anti-TPO) or antithyroglobulin (anti-Tg) antibodies and at least one of: \n\n Abnormal thyroid function that requires substitution treatment with L-thyroxine (TSH > 5 \u03bcIU/ml and decreased or normal levels of fT4 or fT3) \n\n Increased volume of thyroid gland (goiter) \n\n Morphological changes on ultrasound of the thyroid gland \n\n For GD: \n\n A positive titers of thyroid stimulating antibodies (anti-TSI) and \n\n Decreased TSH levels and increased levels of fT4 or fT3 \n\n For Controls: \n\n Otherwise healthy children and adolescents, age- and gender-matched with patients \n\n Absence of previously known chronic disease of autoimmune aetiology or atopy (including those with a history of chronic treatment with antihistamines, anti-inflammatory, corticosteroids or anti-epileptic drugs) \n\n Absence of a family history of autoimmune disease in first-degree relatives \n\n ", - "exclusion_criteria": ": \n\n Not Caucasian origin or affinity among participants \n\n Age of diagnosis above 18 years \n\n Disease duration below 3 months", - "brief_summary": "Hashimoto Thyroiditis (HT) and Graves Disease (GD) are known to be caused by abnormal immune response against self cells and tissues. Epigenetics is a novel field of biology studying the mechanisms by which the environment interacts with the genotype to produce a variety of phenotypes through modifications to chromatin that do not directly alter the DNA sequence. A very limited number of epigenetic studies have been published in patients with HT and GD so far. Therefore, the purpose of this study is to analyze DNA methylation status in White Blood Cells (WBCs) within the promoter regions of genomic sites that have been previously identified as susceptibility loci or sites for autoimmune thyroid disease, such as the CD40L, FOXP3, CTLA4, PTPN22, IL2RA, FCRL3 and HLADRB1 genes.", - "NCTID": "NCT02491567" - }, - { - "brief_title": "Evaluating the Dietary Supplement Anatabloc in Thyroid Health-ASAP (Antabloc Supplementation Autoimmune Prevention)", - "phase": "Phase 2", - "drugs": "['Anatabloc Supplement', 'Placebo']", - "drugs_list": [ - "Anatabloc Supplement", - "Placebo" - ], - "diseases": "['Thyroiditis, Autoimmune']", - "diseases_list": [ - "Thyroiditis", - "Autoimmune" - ], - "enrollment": "165.0", - "inclusion_criteria": "inclusion criteria: \n\n adults 18-70 years of age \n\n having positive antibodies against thyroid peroxidase \n\n having sonographic evidence consistent with a diagnosis of Hashimoto's thyroiditis \n\n ", - "exclusion_criteria": ": \n\n having evidence of end-stage thyroiditis \n\n being a current smoker or smokeless tobacco user \n\n be taking systemic glucocorticoids, interferon-alpha, anti-CD20 antibody, or anti-CTLA-4 antibody \n\n be taking any medication for treatment of autoimmune thyroiditis other than L-thyroxine or equivalent", - "brief_summary": "This is a study to evaluate the safety, tolerability, and potential effects of Anatabloc dietary supplementation on antithyroid autoantibodies, thyroid structure, and thyroid function in subjects with autoimmune thyroiditis.", - "NCTID": "NCT01551498" - }, - { - "brief_title": "Method of Endogenous TSH Stimulation in the Follow-up of Differentiated Thyroid Cancer", - "phase": "", - "drugs": "['L-thyroxin']", - "drugs_list": [ - "L-thyroxin" - ], - "diseases": "['Thyroid Cancer']", - "diseases_list": [ - "Thyroid Cancer" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Differentiated thyroid cancer \n\n treated by thyroidectomy and at least 1 ablation with 131-I > 5 months ago \n\n TSH < 4 imU/L \n\n ", - "exclusion_criteria": ": \n\n Pregnancy \n\n Known metastasis", - "brief_summary": "The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine treatment. In the follow-up of patients it is necessary to induce TSH elevation to test for cancer recurrence. One of the options is to stop L-thyroxin replacement for several weeks. Current pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks in majority of patients.", - "NCTID": "NCT01840332" - } - ], - "2": [ - { - "brief_title": "Diagnosis and Follow-up of Patients With Subclinical Hypothyroidism", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Congenital Hypothyroidism', 'L-Thyroxine', 'Follow-Up']", - "diseases_list": [ - "Congenital Hypothyroidism", - "L-Thyroxine", - "Follow-Up" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n The diagnostic standard for manifest hypothyroidism and subclinical hypothyroidism was defined as follows: \n\n Hypothyroidism - TSH > 40 mU/L and T3 and T4 below the reference range or TSH > 40 mU/L, T3 normal and T4 below the reference range [2] \n\n Subclinical hypothyroidism - TSH \u2265 20 mU/L, T3 and T4 normal or low-normal or TSH > 5.6 mU/L and < 20 mU/L on initial determination and on follow-up or TSH levels increase on follow-up and/or gradually declining T4 levels.", - "exclusion_criteria": "", - "brief_summary": "Long term follow-up of the patients with delayed TSH elevation or subclinical hypothyroidism has been seldom reported. The purpose of this study was to explore the diagnostic criteria for subclinical hypothyroidism and the initial dosage of L-thyroxine through long-term follow up for infants with subclinical hypothyroidism \uff0cand evaluate the curative effect.", - "NCTID": "NCT00497575" - }, - { - "brief_title": "Observational Study With Prospective and/or Retrospective Follow-up, Without Modifying Patient Treatment and Follow-up Practices for the Initial Treatment of Hypothyroidism in France", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Hypothyroidism']", - "diseases_list": [ - "Hypothyroidism" - ], - "enrollment": "1285.0", - "inclusion_criteria": "inclusion criteria: \n\n Recently diagnosed hypothyroid subject (either during the inclusion period, or within the 6 previous months) for whom, data related to the diagnosis is available if the diagnosis was not carried out initially by the investigating doctor \n\n Subject, who has given his/her oral consent for participation \n\n ", - "exclusion_criteria": ": \n\n Subject included in clinical trial or having participated in a clinical trial during the last 3 months \n\n Subject presenting a major and objectifiable risk of not being able to follow-up until the next TSH level (moving, problems encountered during another study, pathology affecting the vital prognosis in the short-term) \n\n All contraindications to L\u00e9vothyrox", - "brief_summary": "This observational survey with prospective and/or retrospective follow-up is designed to study practices for the initial treatment of hypothyroidism in France without modifying subject treatment.", - "NCTID": "NCT01197183" - }, - { - "brief_title": "Selenium Treatment in Autoimmune Thyroiditis (AIT)", - "phase": "", - "drugs": "['L-Selenomethionine']", - "drugs_list": [ - "L-Selenomethionine" - ], - "diseases": "['Autoimmune Thyroiditis', 'Hashimotos Thyroiditis']", - "diseases_list": [ - "Autoimmune Thyroiditis", - "Hashimotos Thyroiditis" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinically approved AIT patients who do not use any medication other than LT4 to keep TSH in the lower half of normal range. \n\n ", - "exclusion_criteria": ": \n\n Any kind of drug use other than LT4 or any kind of known pathology which may effect GIS absorption.", - "brief_summary": "Selenium suppresses autoimmune destruction of thyrocytes and decreases titers of serum TPOAb in AIT patients. Older 4 clinical trials approved the efficacy of the daily dose of 200micg. It's believed that Se saturates the deficient stores of GPX so GPX saves the thyrocytes against to oxidative stresses. Although less than 70 micg/d is sufficient to maximize GPX activity, none of the authors tested the doses less than 200 micg/d. Our hypothesis was that If 100 micg/d can not suppress the TPOAb titers,it means autoimmune destruction can not be blocked by saturation of deficient stores of GPX solely and the mechanism of action requires more than repletion of deficient stores. It's important not only to estimate the optimal dose but to understand the mechanism of action. High dose therapy may also suppress TPOAb levels in Se-non-deficient AIT patients, if it is so, Se therapy may becomes the solely treatment modality which can suppress the autoimmunity in more than 400 million AIT patients. Because there've been no way to suppress autoimmune war and replacement of LT4 had been the only treatment modality for palliation. An other independent part of the study is to test the effect of Se in adolescent AIT patients.", - "NCTID": "NCT00271427" - }, - { - "brief_title": "Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone", - "phase": "", - "drugs": "['thyroxine', 'thyroxine and triiodothyronine']", - "drugs_list": [ - "thyroxine", - "thyroxine and triiodothyronine" - ], - "diseases": "['Hypothyroidism']", - "diseases_list": [ - "Hypothyroidism" - ], - "enrollment": "36.0", - "inclusion_criteria": "inclusion criteria: \n\n Premenopausal women with overt primary hypothyroidism (reduced T4 concentration accompanied by increased TSH concentration at the time of initial diagnosis) who did not receive thyroid hormones \n\n ", - "exclusion_criteria": ": \n\n Peri- and postmenopause \n\n Pregnancy \n\n Major comorbidity \n\n Use of drugs that affect metabolism or bioavailability of thyroid hormones preparations.", - "brief_summary": "The objective of this study was to analyze the features of monotherapy with L-T4 in comparison with combined therapy with L-T4 and L-T3 in patients with primary hypothyroidism.", - "NCTID": "NCT00715572" - }, - { - "brief_title": "Role of Dairy Products in Weight Maintenance", - "phase": "", - "drugs": "['Dairy Foods', 'Dairy Foods']", - "drugs_list": [ - "Dairy Foods", - "Dairy Foods" - ], - "diseases": "['Obesity', 'Weight Gain']", - "diseases_list": [ - "Obesity", - "Weight Gain" - ], - "enrollment": "338.0", - "inclusion_criteria": "inclusion criteria: \n\n Body mass index (BMI) 30-39.9 kg/m2 \n\n Age 25-50 years \n\n No more than 3 kg weight loss during past three months \n\n Negative pregnancy test at entry; women of childbearing potential may be enrolled if they have had a tubal ligation or use one of the following means of contraception: condom, diaphragm, oral or implanted contraceptives, or intrauterine device. Women in exclusive relationships with male partners who have had a successful vasectomy will not be required to use any additional means of birth control. \n\n ", - "exclusion_criteria": ": \n\n BMI < 30 or >40 \n\n Type II diabetes requiring the use of any oral antidiabetic agent and/or insulin (because of confounding effects on body weight regulation) \n\n Adverse response to study foods (lactose intolerance, dairy intolerance, dairy allergy); this will be determined by self-report. \n\n History or presence of significant metabolic disease which could impact on the results of the study (i.e. endocrine, hepatic, renal disease) \n\n History of eating disorder \n\n Presence of active gastrointestinal disorders such as malabsorption syndromes \n\n Pregnancy or lactation \n\n Use of obesity pharmacotherapeutic agents within the last 6 months \n\n Use of over-the-counter anti-obesity agents (e.g. those containing phenylpropanalamine, ephedrine and/or caffeine) within the last 6 months \n\n Recent (past 12 weeks) use of tobacco \n\n Recent (current or past 12 weeks) use of any psychotropic medication \n\n Recent (past four weeks) initiation of an exercise program \n\n Recent (past twelve weeks) initiation of hormone replacement therapy or change in HRT regimen \n\n Recent (past twelve weeks) initiation of hormonal birth control or change in hormonal birth control regimen", - "brief_summary": "The goal of the current study is to determine the role of dairy in similarly preventing weight and fat re-gain in obese adults who have successfully completed a weight loss diet program.240 obese subjects will undergo a meal-replacement-based weight loss plan designed to produce a 10 kg weight loss in 8-12 weeks. Upon achieving the weight loss goal, subjects will be randomly assigned to either a low-dairy or high-dairy eucaloric weight maintenance diet for two years. Macronutrient distribution will be maintained constant and set at approximately the U.S. average. Primary outcomes include changes in body weight, body fat and anatomical distribution of fat (via dual x-ray absorptiometry) and resting metabolic rate and substrate oxidation (via respiratory calorimetry); Secondary outcomes include blood pressure, circulating glucose, insulin, lipids and calcitrophic hormones. on prevention of weight regain in humans has not yet been assessed in clinical trials.", - "NCTID": "NCT00686426" - }, - { - "brief_title": "Weight Gain Prevention", - "phase": "", - "drugs": "['large changes in eating and activity', 'small changes in eating and activity']", - "drugs_list": [ - "large changes in eating and activity", - "small changes in eating and activity" - ], - "diseases": "['Weight Gain']", - "diseases_list": [ - "Weight Gain" - ], - "enrollment": "52.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18-35 \n\n Body mass index between 23 and 30 \n\n Interested in preventing weight gain \n\n ", - "exclusion_criteria": ": \n\n BMI outside of range specified \n\n Age outside of range specified \n\n History of or current eating disorder or substance abuse \n\n Recent weight loss greater than 5% of weight \n\n Currently in another research study that would interfere", - "brief_summary": "The specific aim of the proposed project is to test two separate self-regulation interventions to prevent weight gain in young adults, one based on making sustained small changes in behavior to prevent weight gain and the other on making periodic larger behavior changes resulting in weight loss.", - "NCTID": "NCT00606840" - } - ] - }, - { - "patient_id": "sigir-201413", - "patient": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", - "0": [ - { - "brief_title": "PROSPER: PostpaRtum PrOphylaxiS for PE Randomized Control Trial Pilot", - "phase": "Phase 3", - "drugs": "['Dalteparin Sodium']", - "drugs_list": [ - "Dalteparin Sodium" - ], - "diseases": "['Venous Thromboembolism', 'Postpartum']", - "diseases_list": [ - "Venous Thromboembolism", - "Postpartum" - ], - "enrollment": "62.0", - "inclusion_criteria": "inclusion criteria: \n\n Women must be at high risk for thromboembolism for one of the following reasons: \n\n Known low risk thrombophilia (Known = diagnosed prior to enrollment and low risk thrombophilia includes heterozygous factor V Leiden or prothrombin gene variant or protein C deficiency or protein S deficiency. If not previously tested then assumed not to have thrombophilia). \n\n Immobilization (defined as >90% of waking hours in bed, of a week or more at any point in the antepartum period). \n\n OR any two of the following reasons: \n\n Postpartum infection (fever (temperature>38.5oC) and clinical signs/symptoms of infection and elevated neutrophil count (higher than local lab normal)) \n\n Postpartum hemorrhage (Estimated blood loss >1000 ml during delivery and postpartum) \n\n Pre-pregnancy BMI >25 kg/m2 \n\n Emergency cesarean birth (emergency = not planned prior to onset of labour) \n\n Smoking >5 cigarettes per day prior to pregnancy \n\n Preeclampsia (blood pressure \u2265 140mmHG systolic and/or \u226590 mmHg diastolic on at least one occasion and proteinuria (1+ on urine dipstick or 300mg/dl or total excretion of 300mg/24 hours) or typical end-organ dysfunction. \n\n Infant birth weight (adjusted for sex and gestational age) <3rd percentile (i.e., small for gestational age). \n\n ", - "exclusion_criteria": ": \n\n Less than 6 hours or more than 36 hours since delivery at the time of randomization \n\n Need for anticoagulation as judged by the local investigator, may include but not limited to: \n\n Personal history of previous provoked or unprovoked VTE (DVT or PE) \n\n Continuation of LMWH that was started in the antenatal period for VTE prophylaxis \n\n Mechanical heart valve \n\n Known high-risk thrombophilia (Known = diagnosed prior to enrolment and high-risk thrombophilia includes deficiency of antithrombin (at least 1 abnormal lab result), persistently positive anticardiolipin antibodies (> 30U/ml on two measurements a minimum of six weeks apart), persistently positive Anti B2 glycoprotein antibodies (> 20U/ml on two measurements a minimum of six weeks apart), persistently positive lupus anticoagulant (positive on two measurements a minimum of six weeks apart), homozygous factor V Leiden (FVL), homozygous prothrombin gene mutation (PGM), compound heterozygosity factor V Leiden (FVL) and prothrombin gene mutations (PGM), more than 1 thrombophilia (any combination of 2 or more: FVL, PGM, protein C deficiency, protein S deficiency). If not previously tested then assumed not to have thrombophilia). \n\n Contraindication to heparin therapy, including: \n\n History of heparin induced thrombocytopenia (HIT) \n\n Platelet count of less than 80,000 x 106/L on postpartum Complete Blood Count(CBC) \n\n Hemoglobin \u2264 75 g/L on postpartum CBC \n\n Active bleeding at any site (not resolved prior to randomization) \n\n Excessive postpartum vaginal bleeding (>1 pad per hour prior to randomization). \n\n Documented gastrointestinal ulcer within 6 weeks prior to randomization \n\n History of heparin or LMWH allergy \n\n Severe postpartum hypertension (systolic blood pressure (SBP) > 200mm/hg and/or diastolic blood pressure (DBP) > 120mm/hg) \n\n Severe hepatic failure (INR >1.8 if liver disease suspected) \n\n Have received more than one dose of heparin or LMWH since delivery \n\n < age of legal majority in local jurisdiction (age <18 in Canada) \n\n Prior participation in PROSPER \n\n Unable or refused to consent", - "brief_summary": "The purpose of this study is to determine if it is feasible to conduct a multi-center randomized trial to determine whether a blood thinner, low-molecular-weight-heparin (LMWH), is effective at preventing blood clots, thromboembolism (VTE), in postpartum women at risk.", - "NCTID": "NCT01274637" - }, - { - "brief_title": "Echo-Cardiographic Assessment of Cardiovascular Characteristics During Pregnancy and Postpartum Periods", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pregnancy']", - "diseases_list": [ - "Pregnancy" - ], - "enrollment": "400.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy women \n\n First trimester of a normal pregnancy \n\n Normal baseline echocardiogram \n\n ", - "exclusion_criteria": ": \n\n Pregnancy with more than one fetus. \n\n Any hemodynamically significant cardiac condition \n\n Any known systemic disease \n\n Poor quality echocardiogram", - "brief_summary": "The purpose of this echocardiographic study is to restudy the longitudinal changes in cardiac size and function during and after pregnancy in healthy women using relatively new parameters of systolic and diastolic function as well as classical measures of left ventricle (LV) function using contemporary echocardiographic machines.~We, the researchers at Hillel Yaffe Medical Center, will assess diastolic function and its possible relation to shortness of breath.", - "NCTID": "NCT00522977" - }, - { - "brief_title": "Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression", - "phase": "Phase 4", - "drugs": "['Depot medroxyprogesterone acetate', 'Depot medroxyprogesterone acetate']", - "drugs_list": [ - "Depot medroxyprogesterone acetate", - "Depot medroxyprogesterone acetate" - ], - "diseases": "['Contraception', 'Postpartum Depression', 'Lactation']", - "diseases_list": [ - "Contraception", - "Postpartum Depression", - "Lactation" - ], - "enrollment": "184.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 18 years old and > 24 0/7 weeks pregnant at time of enrollment \n\n Planning to deliver at Magee-Womens Hospital and to breastfeed \n\n Plans to use DMPA for postpartum contraception for at least 6 months \n\n Willing and able to provide informed consent in English and to comply with study protocol \n\n ", - "exclusion_criteria": ": \n\n Intolerance of irregular vaginal bleeding \n\n Severe coagulation disorder \n\n Severe liver disease (LFTs >2x upper limits of normal at time of randomization) \n\n Contraindications to breastfeeding: maternal HIV infection; active herpes simplex with breast lesions; active varicella; active, untreated tuberculosis; antineoplastic, thyrotoxic, or immunosuppressive medications; concern that the infant may have galactosemia \n\n History of breast cancer, reduction or augmentation surgery \n\n History of severe clinical depression \n\n Multiple gestation", - "brief_summary": "The investigators plan to enroll 184 women who are planning to breastfeed and use DMPA after delivery to find out whether the timing of postpartum administration of DMPA (prior to hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of breastfeeding among women who plan to breastfeed their infants.", - "NCTID": "NCT01463202" - }, - { - "brief_title": "Phone-Based Postpartum Continuing Care for Smoking Cessation", - "phase": "", - "drugs": "['Phone-based postpartum continuing care', 'Standard care']", - "drugs_list": [ - "Phone-based postpartum continuing care", - "Standard care" - ], - "diseases": "['Smoking Cessation', 'Pregnancy']", - "diseases_list": [ - "Smoking Cessation", - "Pregnancy" - ], - "enrollment": "130.0", - "inclusion_criteria": "inclusion criteria: \n\n first or second trimester of pregnancy \n\n age 18 or older \n\n self-reported tobacco use in the past 90 days or nicotine-dependence in the past year \n\n ", - "exclusion_criteria": ": \n\n intend to terminate their pregnancy \n\n intend to move out of the city within the next 12 months \n\n are unable to provide informed consent and participate in English", - "brief_summary": "Smoking is a leading cause of death and other negative health outcomes. While a high percentage of women quit smoking during pregnancy, the majority relapse in the first 6 months postpartum. We propose developing and pilot testing a phone-based postpartum continuing care (PPCC) protocol based on existing evidence-based approaches to increase smoking cessation, reduce relapse, increase early re-intervention, and reduce infant exposure to environmental tobacco smoke in the postpartum period.", - "NCTID": "NCT01684592" - }, - { - "brief_title": "Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning Scales", - "phase": "Phase 4", - "drugs": "['Ethinyl Estradiol 35mcg/Norethindrone 1mg', 'Ethinyl Estradiol 20mcg/Norethindrone 1mg']", - "drugs_list": [ - "Ethinyl Estradiol 35mcg/Norethindrone 1mg", - "Ethinyl Estradiol 20mcg/Norethindrone 1mg" - ], - "diseases": "['Postpartum Depressive Mood', 'Postpartum Sexual Function']", - "diseases_list": [ - "Postpartum Depressive Mood", - "Postpartum Sexual Function" - ], - "enrollment": "33.0", - "inclusion_criteria": "inclusion criteria: \n\n 18-45 year old women who desire contraception postpartum for at least 6 weeks. \n\n 18-45 year old women who choose not to use oral contraceptive medication postpartum for at least 6 weeks for the control group. \n\n ", - "exclusion_criteria": " (Medication groups): \n\n Breastfeeding (although this may limit participant enrollment, combined oral contraceptives are contraindicated in this population). \n\n Delivery by cesarean section. \n\n Previous history of depression, mood disorders, or psychiatric disorders. \n\n Any condition (history or presence of) which contraindicates the use of combination OCs, including: \n\n Thrombophlebitis or thromboembolic disorders, known or suspected clotting disorders, deep vein thrombosis, thrombogenic valvulopathies or rhythm disorders. \n\n Pulmonary Embolism. \n\n Cerebrovascular or coronary artery disease or myocardial infarction. \n\n Diabetes mellitus. \n\n Migraine headaches with focal, neurological symptoms. \n\n Chronic renal disease. \n\n Uncontrolled or untreated hypertension. \n\n Cholestatic jaundice. \n\n Known or suspected carcinoma of the breast, endometrial carcinoma, or known or suspected estrogen-dependent neoplasia. \n\n Impaired liver function or disease, hepatic adenomas or carcinomas. \n\n Known hypersensitivity to estrogens and/or progestins. \n\n History of thyroid disorders. \n\n Recent alcohol or drug use. \n\n Smoking and age \u226535 or smokers who will become 35 years of age during the study. \n\n Known history of noncompliance with taking medication. \n\n ", - "brief_summary": "This is a prospective, randomized, controlled cohort study. This study will look at the effect of Ethinyl Estradiol 35mcg/Norethindrone 1mg and Ethinyl Estradiol 20 mcg/Norethindrone 1mg on postpartum depressive symptoms and sexual function scores when compared to a control group using no hormonal contraception. Depressive symptoms and sexual function will be measured using the Edinburgh Postnatal Depression Scale (EPDS), Arizona Sexual Experiences Scale (ASEX), and Brief Index of Sexual Functioning for Women (BISF-W). Participants will begin taking the medication at Week 3 postpartum, and these outcomes will be measured at baseline (0-1 day postpartum), Week 3, and Week 6-7. The investigators hypothesize that there will be an ethinyl estradiol dose related response in EPDS, ASEX, and BISF-W scores at Week 6-7, which would indicate a decrease in depressive symptoms and increase in sexual function in both of the oral contraceptive groups.", - "NCTID": "NCT02210702" - }, - { - "brief_title": "Magnesium Sulfate During the Postpartum in Women With Severe Preeclampsia", - "phase": "Phase 2; Phase 3", - "drugs": "['Magnesium Sulfate']", - "drugs_list": [ - "Magnesium Sulfate" - ], - "diseases": "['Post Partum Severe Preeclampsia']", - "diseases_list": [ - "Post Partum Severe Preeclampsia" - ], - "enrollment": "1114.0", - "inclusion_criteria": "inclusion criteria: \n\n Severe preeclampsia or severe preeclampsia aggregated to chronic hypertension with > 24 weeks of gestation treated with 4-6 grams of magnesium sulfate for impregnation with a minimum of 8 hours continuous of magnesium sulfate before delivery \n\n The study begins to terminate pregnancy \n\n ", - "exclusion_criteria": ": \n\n HELLP syndrome \n\n Eclampsia \n\n Renal insufficiency \n\n Diabetes mellitus \n\n Disease of collagen \n\n Heart disease", - "brief_summary": "There is no evidence that patients receiving magnesium sulfate before birth are required to maintain the drug for 24 hours. Therefore the investigators will have a randomized clinical study in patients with severe preeclampsia who have been treated with impregnation of magnesium sulphate and at least eight hours have received the drug before birth. If the patient agrees and signs the consent is randomized to: 1-receive sulfate for 24 hours postpartum as usual or, 2- not receiving the postpartum magnesium sulfate or other anticonvulsant drugs. This study can be conducted in 12 maternity latin america.", - "NCTID": "NCT02307201" - }, - { - "brief_title": "Involving Men in Maternity Care in Burkina Faso", - "phase": "", - "drugs": "['Partner involvement']", - "drugs_list": [ - "Partner involvement" - ], - "diseases": "['Postpartum Period']", - "diseases_list": [ - "Postpartum Period" - ], - "enrollment": "1144.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 16-18, married, or \n\n Age 18+, in a co-habiting relationship \n\n Pregnant 24-36 weeks \n\n No obstetric risk factors requiring hospital delivery \n\n Lives no more than one hour away on foot, not planning to move from the city \n\n Gives informed consent \n\n ", - "exclusion_criteria": ": \n\n Not meeting inclusion criteria \n\n Declines to participate", - "brief_summary": "The uptake of postpartum contraception, postpartum care attendance and the practice of exclusive breastfeeding are low in Sub-Saharan Africa. Although the involvement of men in maternity care has been shown to be a promising strategy for the achievement of other reproductive health goals, little is known about the effect of their participation on these outcomes. This study aims to test whether the involvement of men can improve care-seeking and promote healthy behaviours among postpartum women in Burkina Faso.", - "NCTID": "NCT02309489" - }, - { - "brief_title": "Retrospective Study of Patients Who Were Treated With Fondaparinux Pre-, Peri- and/or Postpartum for Prophylaxis or Treatment of Venous Thromboembolism", - "phase": "", - "drugs": "['fondaparinux']", - "drugs_list": [ - "fondaparinux" - ], - "diseases": "['Thromboembolism', 'Venous Thromboembolism']", - "diseases_list": [ - "Thromboembolism", - "Venous Thromboembolism" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who were treated with fondaparinux pre-, peri- and/or postpartum for more than 7 days for VTE prophylaxis or treatment, especially those with a history of abortion, and/or stillbirth, VTE, severe fetal and maternal complications during pregnancy, severe inherited or acquired thrombophilias, long-term anticoagulation (e. g. patients with mechanical heart valves) and/or intolerance to heparins or heparinoids or heparin-induced thrombocytopenia (HIT) \n\n ", - "exclusion_criteria": ": \n\n Patients who were treated with fondaparinux for less than 7 days \n\n Patient who were treated with fondaparinux only postpartum", - "brief_summary": "The objective of this retrospective study is to gather information about how fondaparinux is used pre-, peri- and/or postpartum for both the prophylaxis and treatment of venous thromboembolism (VTE) in order to fill an information gap concerning the off-label use of fondaparinux during pregnancy.", - "NCTID": "NCT01004939" - }, - { - "brief_title": "Stopping Postpartum Vitamin A Supplementation: Missing Concealed Benefit", - "phase": "Phase 2; Phase 3", - "drugs": "['Vitamin A (<3-day postpartum)', 'Vitamin A (6 wk postpartum)', 'Vitamin A (<3-day and 6 wk postpartum)', 'Placebo']", - "drugs_list": [ - "Vitamin A (<3-day postpartum)", - "Vitamin A (6 wk postpartum)", - "Vitamin A (<3-day and 6 wk postpartum)", - "Placebo" - ], - "diseases": "['Vitamin A Deficiency']", - "diseases_list": [ - "Vitamin A Deficiency" - ], - "enrollment": "160.0", - "inclusion_criteria": "inclusion criteria: \n\n Pregnant women >-18 years of age with low-risk obstetric \n\n ", - "exclusion_criteria": ": \n\n Pregnant women expecting a multiple birth \n\n Take vitamin A supplements during postpartum apart from study intervention \n\n Premature birth \n\n Newborn babies with birth defects and / or other serious diseases", - "brief_summary": "The purpose of this study is to evaluate the effect of post-partum maternal vitamin A supplementation on breast milk bioactive compounds and immune status, growth and morbidity of children in the first four months of life.", - "NCTID": "NCT02043223" - }, - { - "brief_title": "nuMoM2b Heart Health Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous Episode', 'Breathing-Related Sleep Disorder']", - "diseases_list": [ - "Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition", - "Delivered During Previous Episode", - "Breathing-Related Sleep Disorder" - ], - "enrollment": "4509.0", - "inclusion_criteria": "inclusion criteria: \n\n Interval Contact: \n\n Agreed to contact for future studies during nuMoM2b and not subsequently withdrawn from the cohort. \n\n Have pregnancy outcome data from the nuMoM2b study. \n\n At least 18 years of age (to begin interval contact attempts once nuMoM2b participant reaches age 18). \n\n Provision of verbal consent for telephone interview or acknowledgement of consent with completion of the web-based self-administered questionnaire. \n\n In-clinic Visit: \n\n Consented for participation in interval contacts and not subsequently withdrawn \n\n Between 2 and 3.5 years after the nuMoM2b pregnancy ended \n\n Self-report at least 6 months postpartum from any subsequent pregnancy \n\n Self-report not currently pregnant \n\n Able to provide informed consent \n\n Provision of written, signed, informed consent for the 2 to 3.5 year in-clinic assessment \n\n Not currently pregnant by urine pregnancy test administered in the clinic following consent \n\n In-home Sleep Breathing Assessment after the In-Clinic Visit: \n\n Participation in the in-clinic visit \n\n Participation in the sleep breathing substudy of nuMoM2b with at least one sleep breathing assessment providing valid data \n\n Not currently using positive airway pressure (PAP) therapy or other approved treatments for sleep apnea such as oral appliances and nasal therapy patch (Provent) \n\n Not currently on continuous oral steroid therapy for 14 days or more to treat asthma \n\n Not currently using oxygen supplementation to treat a medical condition \n\n Able to provide informed consent and deemed likely to return equipment in a reasonable period \n\n Provision of written, signed, informed consent for the sleep breathing assessment for the nuMoM2b Heart Health Study \n\n ", - "exclusion_criteria": ": \n\n Inability or refusal to provide informed consent for the study component.", - "brief_summary": "This study is looking at the relationship between experiences during pregnancy and cardiovascular health 2 to 3\u00bd years later. The investigators are recruiting women from the approximately 10,000 women who were enrolled and followed over the course of their first pregnancy in another study.", - "NCTID": "NCT02231398" - }, - { - "brief_title": "The Effect of a Father Inclusive Psychoeducation Program on Postnatal Depression", - "phase": "", - "drugs": "['Psychoeducation program']", - "drugs_list": [ - "Psychoeducation program" - ], - "diseases": "['Pregnancy']", - "diseases_list": [ - "Pregnancy" - ], - "enrollment": "1152.0", - "inclusion_criteria": "inclusion criteria: \n\n aged 18 or above; \n\n first-time parents; \n\n able to speak and read the Chinese language; and \n\n Hong Kong residents. \n\n ", - "exclusion_criteria": ": \n\n couples with past or family psychiatric history", - "brief_summary": "Study hypothesis: Childbearing couples who receive the father inclusive psychoeducation program will have: (a) a lower level of depressive symptoms, (b) a higher level of marital relationship, and (c) a higher level of quality of life at 6 weeks, 6 months and one year postpartum than those who receive the usual perinatal care.", - "NCTID": "NCT02010840" - }, - { - "brief_title": "Carbetocin at Elective Cesarean Delivery", - "phase": "", - "drugs": "['Carbetocin', 'Carbetocin', 'Carbetocin', 'Carbetocin', 'Carbetocin']", - "drugs_list": [ - "Carbetocin", - "Carbetocin", - "Carbetocin", - "Carbetocin", - "Carbetocin" - ], - "diseases": "['Postpartum Hemorrhage']", - "diseases_list": [ - "Postpartum Hemorrhage" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients planned for elective cesarean delivery under spinal anesthesia; \n\n All patients who gave written informed consent to participate in this study. \n\n ", - "exclusion_criteria": ": \n\n All patients who refuse to give written informed consent. \n\n All patients who claim allergy or hypersensitivity to carbetocin or oxytocin. \n\n All patients with conditions that predispose to uterine atony and postpartum hemorrhage such as placenta previa, multiple gestation, preeclampsia, eclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis. \n\n All patients with hepatic, renal, and vascular disease, \n\n All patients requiring general anesthesia prior to the administration of the study drug.", - "brief_summary": "Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly uterotonic drug used to prevent and treat PPH in North America, however, there are some limitations to its use. Oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater efficacy rate. However, a dose response to determine the minimum effective dose of carbetocin has not yet been published.~We hypothesize that a dose-response study will establish the minimum dose of carbetocin required to produce appropriate contractility in 95% of the women (ED95) undergoing elective cesarean delivery.", - "NCTID": "NCT01262742" - }, - { - "brief_title": "Carbetocin at Elective Cesarean Delivery Part 2", - "phase": "", - "drugs": "['Carbetocin', 'Carbetocin', 'Carbetocin', 'Carbetocin', 'Carbetocin']", - "drugs_list": [ - "Carbetocin", - "Carbetocin", - "Carbetocin", - "Carbetocin", - "Carbetocin" - ], - "diseases": "['Postpartum Hemorrhage']", - "diseases_list": [ - "Postpartum Hemorrhage" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients planned for elective cesarean delivery under spinal anesthesia. \n\n All patients who give written informed consent to participate in this study. \n\n ", - "exclusion_criteria": ": \n\n All patients who refuse to give written informed consent. \n\n All patients who claim allergy or hypersensitivity to carbetocin or oxytocin. \n\n All patients with conditions that predispose to uterine atony and postpartum hemorrhage such as placenta previa, multiple gestation, preeclampsia, eclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis. \n\n All patients with hepatic, renal, and vascular disease, \n\n All patients requiring general anesthesia prior to the administration of the study drug.", - "brief_summary": "Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most common uterotonic drug used to prevent and treat PPH in North America, however, there are some limitations to its use. Oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater efficacy rate. However, a dose response to determine the minimum effective dose of carbetocin has not yet been published. The investigators hypothesize that the minimum effective dose (ED90) is above 20mcgs and below 80mcgs in women undergoing elective Cesarean delivery.", - "NCTID": "NCT01428817" - }, - { - "brief_title": "Postpartum Uterine Regression", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Uterine Leiomyoma']", - "diseases_list": [ - "Uterine Leiomyoma" - ], - "enrollment": "374.0", - "inclusion_criteria": "inclusion criteria: \n\n Participants in the Right From The Start Study must be 18 years old or older, pregnant, enrolled by 10 weeks of gestation, planning to carry pregnancy to term, no plans to move before delivery, and English speaking. Those who are found to have fibroids at either their 7-week, or 22-week ultrasound examination are eligible for this further postpregnancy study. \n\n A small substudy of 30 women having MRIs to evaluate the sensitivity of the ultrasound imaging will include only participants with a single fibroid found at the early pregnancy ultrasound. \n\n ", - "exclusion_criteria": " FOR MRI: \n\n ", - "brief_summary": "Uterine leiomyomas are the leading cause of hysterectomy in the United States, accounting for over 200,000 procedures each year. Most epidemiologic studies of uterine leiomyoma show that parity has a protective association with leiomyoma, but the mechanism is not known. Both epidemiologic data and data from an animal model indicate that the protective association is not an artifact resulting from reduced fertility among women with fibroids. We hypothesize that the process of uterine regression following delivery results in loss of small fibroids due to selective apoptosis of transformed cells and the extensive remodeling of the entire uterus.", - "NCTID": "NCT00341848" - }, - { - "brief_title": "Acupuncture for Shortness of Breath in Cancer Patients", - "phase": "", - "drugs": "['Acupuncture']", - "drugs_list": [ - "Acupuncture" - ], - "diseases": "['Lung Neoplasms', 'Breast Neoplasms']", - "diseases_list": [ - "Lung Neoplasms", - "Breast Neoplasms" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of local or metastatic breast or lung cancer \n\n Shortness of breath with onset after cancer diagnosis \n\n Life expectancy of at least 4 weeks \n\n ", - "exclusion_criteria": ": \n\n Prior acupuncture \n\n Other conditions suspected of causing shortness of breath, such as congestive heart failure, sarcoid disease, pneumonia, or obesity \n\n No chest wall deformity \n\n Neuromuscular disorders \n\n Pulmonary vascular disease \n\n Anemia \n\n Uncontrolled pain or infection \n\n Heart valve dysfunction", - "brief_summary": "The purpose of this study is to determine whether acupuncture is effective in relieving shortness of breath among breast and lung cancer patients.", - "NCTID": "NCT00067691" - }, - { - "brief_title": "Comparison of Low and Intermediate Dose Low-molecular-weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy", - "phase": "Phase 4", - "drugs": "['Low dose nadroparin', 'Intermediate dose nadroparin', 'Low dose enoxaparin', 'Intermediate dose enoxaparin', 'Low dose dalteparin', 'Intermediate dose dalteparin', 'Fixed low dose tinzaparin', 'Intermediate dose tinzaparin']", - "drugs_list": [ - "Low dose nadroparin", - "Intermediate dose nadroparin", - "Low dose enoxaparin", - "Intermediate dose enoxaparin", - "Low dose dalteparin", - "Intermediate dose dalteparin", - "Fixed low dose tinzaparin", - "Intermediate dose tinzaparin" - ], - "diseases": "['Deep Venous Thrombosis', 'Pulmonary Embolism']", - "diseases_list": [ - "Deep Venous Thrombosis", - "Pulmonary Embolism" - ], - "enrollment": "1110.0", - "inclusion_criteria": "inclusion criteria: \n\n Age: 18 years or older, and; \n\n Pregnancy confirmed by urinary pregnancy test, and; \n\n Gestational age < 14 weeks, and; \n\n Previous objectively confirmed VTE, either unprovoked, in the presence of use of oral contraceptives or estrogen/progestagen use, or related to pregnancy or the postpartum period, or minor risk factors (e.g. long distance travel, minor trauma). \n\n ", - "exclusion_criteria": ": \n\n Previous VTE related to a major provoking risk factor (e.g. surgery, major trauma or plaster cast immobilisation in the 3 months prior to VTE) as the sole risk factor, or; \n\n Indication for treatment with therapeutic dose anticoagulant therapy (e.g. treatment of acute VTE; permanent use of therapeutic anticoagulants outside of pregnancy), or; \n\n Inability to provide informed consent, or; \n\n Any contraindication listed in the local labelling of LMWH.", - "brief_summary": "This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACCP), but it is not known which dose is more efficacious in preventing recurrent venous thromboembolism in pregnancy.~Patients enter the study and will be randomized as soon as a home test confirms pregnancy. LMWH will be administered until 6 weeks postpartum. Follow-up will continue until 3 months postpartum. Patients will be recruited by their treating physician, either an obstetrician or internist.", - "NCTID": "NCT01828697" - }, - { - "brief_title": "Randomized Trial of Amoxicillin Versus Placebo for (Fast Breathing) Pneumonia", - "phase": "", - "drugs": "['Placebo', 'Amoxicillin']", - "drugs_list": [ - "Placebo", - "Amoxicillin" - ], - "diseases": "['Pneumonia', 'Tachypnea']", - "diseases_list": [ - "Pneumonia", - "Tachypnea" - ], - "enrollment": "4000.0", - "inclusion_criteria": "inclusion criteria: \n\n History of cough or difficult breathing < 14 days (observed or reported) AND \n\n Respiratory rate \u2265 50 breaths per minute in children 2 to <12 months (on two consecutive readings by independent physicians) OR respiratory rate \u2265 40 breaths per minute in children12- 59 months (on two consecutive readings by independent physicians) AND \n\n Written informed consent by a legal guardian \n\n ", - "exclusion_criteria": ": \n\n Previously enrolled in study \n\n Pedal edema \n\n History of hospitalization in last two weeks \n\n With severe lower chest wall in-drawing \n\n Known asthmatics,TB or other severe illness \n\n Antibiotics taken in last 48 hours \n\n Bulging fontanel \n\n Congenital heart disease \n\n Any surgical condition requiring hospitalization \n\n Out of catchment area \n\n Any general danger sign as defined by WHO: Stridor when calm; hypoxia (SaO2 < 90% in air) ; inability to feed; persistent vomiting (after three attempts to feed the baby within \u00bd hour); convulsions; reduced conscious level", - "brief_summary": "The relative benefits and risks of antibiotic therapy in WHO defined fast breathing pneumonia in pre-school children in resource limited settings are controversial both at an individual and public health level. Most infections are viral or self-limiting and non-selective drug treatment has contributed to the global epidemic of antibiotic resistance. There is no high quality trial evidence in managing children with fast breathing in community settings and the WHO itself has called for evidence on which to update guidance. The investigators proposed non inferiority trial comparing standard antibiotic treatment with placebo in poor urban slum settings in South Asia to address this deficit.", - "NCTID": "NCT02372461" - }, - { - "brief_title": "Evaluation of Breastfeeding Support After Short Time Hospitalization", - "phase": "", - "drugs": "['New Breastfeeding Counselling', 'Treatment as usual']", - "drugs_list": [ - "New Breastfeeding Counselling", - "Treatment as usual" - ], - "diseases": "['Breastfeeding']", - "diseases_list": [ - "Breastfeeding" - ], - "enrollment": "3541.0", - "inclusion_criteria": "inclusion criteria: \n\n pregnant women (gestational week 35-36) \n\n ", - "exclusion_criteria": ": \n\n women with known physical, psychological and/or social illness/problem that result in hospitalization more than 50 hours after delivery \n\n women with known pregnancy related illness that result in hospitalization more than 50 hours after delivery \n\n Women not understanding or speaking Danish \n\n women expecting multiple babies \n\n women having decided not to breastfeed \n\n women expecting to deliver at another hospital than the one she has been visiting during pregnancy", - "brief_summary": "The purpose of this study is to evaluate if the developed theory and evidence based programme has a positive effect on mother's breastfeeding self efficacy, establishing an effective breastfeeding and breastfeeding duration after short time hospitalization.", - "NCTID": "NCT01620723" - }, - { - "brief_title": "Human Safety of Capsaicin Inhalation Challenge Testing for Young and Older Men", - "phase": "Phase 1", - "drugs": "['biological/vaccine']", - "drugs_list": [ - "biological/vaccine" - ], - "diseases": "['COPD']", - "diseases_list": [ - "COPD" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Men of ages 18 and 30 (Dates of birth 1973-1985) or 55-92 years old (Dates of birth 1911-1948). \n\n Must not currently be a cigarette smoker. If an ex-smoker then has not smoked for at least 10 years and consumption were no more than 10 pack years. \n\n Agrees to volunteers for the study and willing to sign the informed consent form. \n\n There were negative/normal screening tests for the following \n\n Responses to the questionnaire deny current and prior respiratory diseases (including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung d9sase) and no current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis). Subjects must not be taking any cardiac medications or admit to a physician-diagnosed cardiac condition. \n\n Normal spirometry measurements with FEV1 & FVC greater than 75% predicted and FEV1/FVC more than 69% \n\n Impedance oscillometry were within normal limits \n\n Negative physical examination of the chest with absence of wheezing and crackles on auscultation of the chest. \n\n Exhaled nitric oxide concentration is less than 35 ppb for younger and less than 65 ppb for older groups \n\n ", - "exclusion_criteria": ": \n\n men of: ages < 18, 31-54 and >92 years old; \n\n current cigarette smokers or exsmokers who have smoked within the past 10 years and/or smoked more than 10 pack/years; \n\n refusal to volunteer for the study and not willing to sign the informed consent form; \n\n screening test not considered normal by physician/PI and showing one or more of the following: \n\n one or more positive response to the questionnaire(e.g., current or past respiratory diseases including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung disease; and/or; current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis) and/or; admitting to taking a cardiac medication and/or; or physician-diagnosed cardiac condition (e.g., coronary heart disease, angina, myocardial infarction, valvular heart disease, cardiomyopathy, etc.); \n\n Abnormal spirometry measurements (FEV1 &/or FVC <75% predicted and FEV1/FVC <69%); \n\n Positive physical examination (performed by Physician/PI) with presence of wheezing and/or crackles on auscultation of the chest; \n\n Impulse oscillometry >4 times normal limits; \n\n Exhaled nitric oxide of >35ppb for younger group and >65 ppb for older group. -", - "brief_summary": "In 2004, the investigators initiated a human Capsaicin inhalation experiment under an Investigational New Drug (IND) protocol approved by the FDA (IND 69,642) and the subject safety procedures instituted and approved by the Institutional Review Board (IRB). As part of the study protocol, inhaled Capsaicin solutions were analyzed using high performance liquid chromatography (HPLC). The investigation employed safety procedures while conducting the human inhalation investigations. In addition, during our investigations we observed discrepancies between the predicted Capsaicin concentrations mixed by a registered pharmacist and the actual capsaicin concentrations determined by HPLC. The stability of Capsaicin solutions stored over a seven month period and refrigerated at 4degrees C and protected against ultraviolet light were examined.", - "NCTID": "NCT01621685" - }, - { - "brief_title": "Long-term Oxygen Treatment Trial", - "phase": "Phase 3", - "drugs": "['Supplemental oxygen therapy']", - "drugs_list": [ - "Supplemental oxygen therapy" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "738.0", - "inclusion_criteria": "inclusion criteria: \n\n Age at least 40 years \n\n COPD \n\n Dyspnea, determined by Modified Medical Research Council (MMRC) scale of at least 1 \n\n Dyspnea and lung disease process dominated by COPD in judgment of the study physician \n\n Participant must meet one of the following: \n\n Post-bronchodilator forced expiratory volume in 1 second (FEV1) percent less than or equal to 70% predicted \n\n Post-bronchodilator forced expiratory volume in 1 second (FEV1) percent >70% predicted and LOTT study physician determines that there is radiologic evidence of emphysema \n\n Post-bronchodilator FEV1/forced vital capacity (FVC) less then 0.70 \n\n Participant must meet either of the following oxygen saturation criteria: \n\n Oxygen saturation of at least 89% and no greater than 93% after sitting quietly on room air, without hyperventilation and without pursed lips breathing during oximetry \n\n Resting oxygen saturation 94% or greater and desaturation during exercise defined as saturation below 90% for at least 10 seconds during the 6 minute walk test \n\n If participant is on supplemental oxygen at the start of screening, all of the following must be met prior to randomization: \n\n Participant agrees to stop using oxygen if randomized to no oxygen \n\n Participant's physician agrees in writing to rescind order for oxygen if participant is randomized to no oxygen \n\n Participant must report not using oxygen on the day of randomization and must report not using oxygen for the 4 calendar days prior to randomization \n\n Satisfactory resolution of logistics of continuation with same oxygen company with waiver of cost sharing obligations or switch to new company that will waive cost sharing obligations if participant is randomized to oxygen \n\n At least 10 pack-years of tobacco cigarette smoking before study entry \n\n Agreement not to smoke while using supplemental oxygen \n\n Medicare beneficiary with both Part A and Part B coverage or insurance OR personally willing to cover costs typically covered by Medicare \n\n Approval of study physician for randomization to either treatment group \n\n Completion of all required prerandomization assessments within 60 days of initiating study entry \n\n Randomization within 60 days of initiating eligibility evaluation \n\n Consent \n\n ", - "exclusion_criteria": ": \n\n Less than 30 days post treatment for acute exacerbation of COPD as of initiating eligibility evaluation (less than 30 days from last dose of antibiotics or since a new or increased dose of systemic corticosteroids was initiated); chronic use of systemic corticosteroids while health is stable is not exclusionary \n\n COPD exacerbation requiring antibiotics, new or increased dose of systemic corticosteroids, or oxygen treatment after screening starts and prior to randomization (chronic use of corticosteroids while health is stable is not exclusionary) \n\n Less than 30 days post discharge from an acute care hospital after acute care hospitalization for COPD or other condition, as of initiating eligibility evaluation (participant may be in a rehab hospital at time of screening) \n\n New prescription of supplemental oxygen after screening starts and before randomization \n\n Thoracotomy, sternotomy, major cardiopulmonary intervention (e.g., lung resection, open heart surgery, etc.), or other procedure in the 6 months before study entry likely to cause instability of pulmonary status \n\n Non-COPD lung disease that affects oxygenation or survival \n\n Epworth Sleepiness Scale score greater than 15 \n\n Desaturation below 80% for at least 1 minute during the 6-minute walk test \n\n Disease or condition expected to cause death, inability to perform procedures for the trial, or inability to comply with therapy within 6 months of random assignment, as judged by the study physician \n\n Participation in another intervention study", - "brief_summary": "Chronic obstructive pulmonary disease (COPD) is a serious respiratory disease in which the airways in the lungs are partially blocked, resulting in symptoms of chest tightness, coughing, and difficulty breathing. Currently, there are many available treatments for managing COPD symptoms and improving quality of life, including medications, lifestyle changes, oxygen therapy, and pulmonary rehabilitation. For people with severe COPD that is characterized by very low blood oxygen levels at rest, long term oxygen therapy can help to prolong life and promote feelings of well-being. However, the effectiveness of supplemental oxygen therapy for people with COPD that is characterized by only moderately low blood oxygen levels at rest or normal blood oxygen at rest and desaturation on exercise is not known. This study will evaluate the effectiveness of supplemental oxygen therapy in treating people with COPD who have moderately low blood oxygen levels at rest or who have normal blood oxygen levels at rest, but have low or very low blood oxygen levels during exercise.", - "NCTID": "NCT00692198" - }, - { - "brief_title": "Thromboprophylaxis in Pregnant Women in Hospital: A Prospective Clinical Trial", - "phase": "", - "drugs": "['Enoxaparin', 'No intervention']", - "drugs_list": [ - "Enoxaparin", - "No intervention" - ], - "diseases": "['Thrombophilia Associated With Pregnancy', 'Perioperative/Postoperative Complications', 'Venous Thrombosis', 'Pulmonary Embolism', 'Other Specified Risk Factors in Pregnancy', 'Deep Vein Thrombosis']", - "diseases_list": [ - "Thrombophilia Associated With Pregnancy", - "Perioperative/Postoperative Complications", - "Venous Thrombosis", - "Pulmonary Embolism", - "Other Specified Risk Factors in Pregnancy", - "Deep Vein Thrombosis" - ], - "enrollment": "7212.0", - "inclusion_criteria": "inclusion criteria: \n\n All pregnant women hospitalized. \n\n ", - "exclusion_criteria": ": \n\n Previous use of anticoagulation", - "brief_summary": "Hospitalization in pregnancy and childbirth greatly increases the thromboembolic risk of these patients. The application of a protocol for assessing the risk of VTE reduces mortality and morbidity of these phenomena.", - "NCTID": "NCT02600260" - }, - { - "brief_title": "Identification of Early Predictors of Fetomaternal Hemorrhage", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Fetomaternal Hemorrhage', 'Neonatal Anemia']", - "diseases_list": [ - "Fetomaternal Hemorrhage", - "Neonatal Anemia" - ], - "enrollment": "39.0", - "inclusion_criteria": "inclusion criteria: \n\n Women admitted for term delivery (delivery between 37 0/7 and 41 6/7 weeks from the last menstrual period) to the Mount Sinai Medical Center \n\n ", - "exclusion_criteria": ": \n\n Women carrying fetuses with known fetal anomaly. \n\n Women unable to complete the consent process due to likely precipitous delivery, severe labor discomfort, or fetal distress requiring immediate intervention.", - "brief_summary": "Objectives: 1) To determine risk factors for fetomaternal hemorrhage. 2) To identify a cost-effective method to detect fetomaternal hemorrhage prior to significant fetal anemia.~Significance/Background: Fetomaternal hemorrhage (FMH) is a condition in which occurs when the placenta transfers blood from the fetus to the mother. Normally, nutrition and gasses pass from mother to baby through the placenta and only waste products pass from baby to mother through the placenta. Whole blood cells do not normally cross the placenta in significant amounts. Mild FMH, where a small amount of whole blood passes from fetus to mother but does not hurt the mother or baby, occurs in about 75% of pregnancies. A pregnant woman does not know this occurs. It is only discovered if a special blood test that is labor-intensive to perform and difficult to interpret called the Kleihauer-Betke acid elution test is done. As mild FMH hurts no one, this test is not part of routine care. In most cases, testing is done only if a baby is born sick with unexplained anemia. Severe FMH, which can cause the baby to become sick from anemia (low red blood cell count) is caused by large blood loss into the mother, occurs in only 1-3 per 1000 births. Severe anemia caused by FMH can result in death of the baby before or after birth, or significant illness in the newborn period. Short term problems for the baby include difficulty breathing, difficulty maintaining blood pressure, and difficulty providing oxygen to all parts of the body. This can cause multiple problems with the function of internal organs including the liver, kidneys, intestines, and brain. Babies who become sick from severe FMH can develop long-term problems including cerebral palsy (a lifelong problem with body movements) and/or mental retardation.~It is not known why some pregnancies are affected by FMH and others are not. It is thought that FMH may occur more frequently now than in the past, but no one knows why. If identified early, FMH is readily treatable by blood transfusion of the baby before or after birth and/or early delivery. Current laboratory testing for FMH is difficult and expensive. There is great need identify high risk patients early in pregnancy in order to treat the condition before the baby gets sick.~Approach: Five hundred women will be asked to participate in the study at the time they are admitted to the Mount Sinai labor floor for delivery at term. After birth, newborns of study mothers will be tested for anemia. Mothers of anemic babies will donate blood for confirmation of FMH by established laboratory methods as well as for development of a new laboratory screening protocol. All mothers will provide medical, social, environmental, and full pregnancy history. Risk factors for FMH will be identified by statistical analysis of this information.", - "NCTID": "NCT01232387" - }, - { - "brief_title": "Change in Peripheral Oxygen Saturation by Using Different Breathing Procedures in High Altitude", - "phase": "", - "drugs": "['Breathing procedure 1', 'Breathing procedure 2']", - "drugs_list": [ - "Breathing procedure 1", - "Breathing procedure 2" - ], - "diseases": "['Acute Mountain Sickness']", - "diseases_list": [ - "Acute Mountain Sickness" - ], - "enrollment": "30.0", - "inclusion_criteria": "", - "exclusion_criteria": ": \n\n acute clinically significant inter-current diseases", - "brief_summary": "In this investigation the researchers explore whether different types of breathing procedures can improve the peripheral oxygen saturation to reduce the risk of becoming a acute mountain sickness or a high altitude pulmonary edema.", - "NCTID": "NCT01468194" - }, - { - "brief_title": "Venous Thromboembolism Prophylaxis Post Cesarean Section", - "phase": "", - "drugs": "['TINZAPARIN', 'PLACEBO']", - "drugs_list": [ - "TINZAPARIN", - "PLACEBO" - ], - "diseases": "['Bleeding', 'Venous Thromboembolism']", - "diseases_list": [ - "Bleeding", - "Venous Thromboembolism" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 18 years old. \n\n Delivered by cesarean section (emergency or planned). \n\n Signed, informed consent. \n\n Ready access to a local health service. \n\n Capable of using Tinzaparin. \n\n ", - "exclusion_criteria": ": \n\n at high risk for thromboembolism (any one of the following): \n\n age more than 35 years old \n\n obesity (more than 80 kg) \n\n parity more than 4 \n\n gross varicose veins \n\n current infection \n\n pre-eclampsia \n\n immobility prior to surgery (more than 4 days) \n\n Major current disease: including heart or lung disease, cancer,inflammatory bowel disease and nephrotic syndrome. \n\n Extended major pelvic or abdominal surgery (e.g. cesarean hysterectomy) \n\n Patients with a family history of VTE \n\n History of superficial phlebitis \n\n More than 36 hours since delivery \n\n Need for anticoagulation, including: \n\n women with a confirmed thrombophilia \n\n women with paralysis of lower limbs \n\n women with personal history of VTE \n\n women with antiphospholipid antibody syndrome (APLA) \n\n women with mechanical heart valves \n\n Contraindication to heparin therapy, including history of heparin induced thrombocytopenia.", - "brief_summary": "Pregnancy is associated with an overall 5-10 fold increased risk of venous thromboembolism (VTE). VTE remains the most common cause of maternal death in the developed world. It is up to 10 times more common in pregnant women than non-pregnant women of comparable age. More than a third of pregnancy-related VTE occurs during the six weeks after delivery. When compared with vaginal delivery, cesarean delivery further increases the risk of pregnancy associated VTE by three-fold.", - "NCTID": "NCT01321788" - }, - { - "brief_title": "Be Healthy in Pregnancy (BHIP) With Nutrition and Exercise", - "phase": "", - "drugs": "['Structured + monitored nutrition and exercise intervention']", - "drugs_list": [ - "Structured + monitored nutrition and exercise intervention" - ], - "diseases": "['Pregnancy Complications', 'Weight Gain']", - "diseases_list": [ - "Pregnancy Complications", - "Weight Gain" - ], - "enrollment": "242.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy pregnant females > 18 years of age with singleton pregnancies (either nulliparous or multiparous); \n\n less than 17 weeks gestation; \n\n a pre pregnancy BMI < 40 kg/m2 (owing to the fact that severe obesity with BMI> 40 may have limitations with respect to physical activity); \n\n plans to deliver at a Hamilton or London regional hospital or by home birth and willing to attend research visits at the community site where they were recruited; \n\n able to tolerate dairy foods; \n\n approval of primary care provider; \n\n able to provide signed informed consent. \n\n ", - "exclusion_criteria": ": \n\n unable to understand some English; \n\n type 1 or type 2 diabetes; \n\n known contraindications to exercise as recommended by the Canadian clinical practice guidelines for pregnancy; \n\n severe gastrointestinal diseases or conditions; \n\n any significant heart, kidney, liver or pancreatic diseases; \n\n pre-existing diabetes; \n\n currently smoking; \n\n a depression score 12 or above on the validated Edinburgh depression questionnaire.", - "brief_summary": "Excess weight gain in pregnancy is a major problem affecting 55-75% of Canadian women who enter pregnancy overweight or obese and about 40% of women who are normal weight. Excess weight gain puts mothers at risk for health problems such as diabetes and developing or sustaining obesity after pregnancy, and puts their babies at risk of being born too large or developing related health problems. Mothers will be randomized to a structured high dairy protein diet and walking program or the usual care by their care provider. The investigators research questions are: Will a structured nutrition and exercise program in pregnancy compared to usual prenatal care increase the chance that mothers will achieve pregnancy weight gain within the current recommendations; improve health measures, in mother and infant at six months post-partum; to evaluate the benefits of a high dairy intake in pregnancy on maintenance of bone status in the mother and bone health outcomes in the child in early life (6 months); and to investigate the interactions between genes associated with bone health and high dairy diet supplementation on bone status in mothers during pregnancy, and bone health in mothers post-delivery and children to 6 months of age. Mothers' weight, physical activity and adherence to the nutrition plan will be assessed until birth and at follow-up with their infants at 6 months after birth. The research team will ensure new information is quickly transferred to programs to assist women to have healthier pregnancies.", - "NCTID": "NCT01689961" - }, - { - "brief_title": "A Neurocognitive and Immunological Study of a New Formula for Healthy Infants", - "phase": "", - "drugs": "['New infant formula', 'Standard infant formula', 'Breastfeeding']", - "drugs_list": [ - "New infant formula", - "Standard infant formula", - "Breastfeeding" - ], - "diseases": "['Infant Development']", - "diseases_list": [ - "Infant Development" - ], - "enrollment": "220.0", - "inclusion_criteria": "inclusion criteria: \n\n Full-term newborns (>37 weeks and <41 weeks gestation) \n\n Adequate birth weight for his gestational age (between 3-97 percentiles) \n\n Inclusion age: from 0 to 2 months (60 days) in the formula fed groups \n\n Inclusion age: 2-6 months (180 days) in the breastfeeding group \n\n Maximum 30 days of exclusive breastfeeding in the formula fed groups \n\n From 30 days on, exclusive or >70% infant formula in the formula fed groups \n\n Normal Apgar score: 7-10 \n\n Umbilical pH \u2265 of 7.10 \n\n Availability to continue during the whole study period \n\n Informed consent signed ( parent/legal representative) \n\n ", - "exclusion_criteria": ": \n\n Participating in other studies. \n\n Nervous system disorders (hydrocephalic, perinatal hypoxia, intraventricular hemorrhage, neonatal meningitis, septic shock, West Sd...). \n\n Gastrointestinal disorders (cow's milk protein allergy, lactose intolerance) \n\n Mother's disease history or during pregnancy: neurological and metabolic diseases, diabetes mellitus type 1, hypothyroidism, undernutrition, infections TORCH complex. \n\n Mothers receiving anxiolytic or antidepressant treatment during pregnancy or other potentially harmful drug treatments for infants' neurodevelopment. \n\n Infant's family who in the investigators assessment cannot be expected to comply with the protocol.", - "brief_summary": "To compare the neurocognitive and immunological development in infants fed a new infant formula with functional specific nutrients to infants consuming a standard infant formula.", - "NCTID": "NCT02094547" - }, - { - "brief_title": "Bioequivalence Study of Torrent Pharmaceuticals Ltd's Felodipine Extended-Release Tablets Under Fasting Condition", - "phase": "Phase 1", - "drugs": "[\"Torrent's Felodipine Extended-Release Tablets\"]", - "drugs_list": [ - "Torrent's Felodipine Extended-Release Tablets" - ], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Healthy males within the age range of 18 to 50 years. \n\n A body mass index within 18-25 Kg/m2. \n\n Given written informed consent to participate in the study. \n\n Absence of diseases markers of HIV 1 & 2, Hepatitis B & C virus and RPR. \n\n Absence of significant disease or clinically significant abnormal laboratory \n\n values on laboratory evaluation, medical history and physical examination during the screening. \n\n A normal 12-lead ECG. \n\n A normal chest X-Ray. \n\n Comprehension of the nature and purpose of the study and compliance with the requirements of the entire protocol. \n\n No history or no evidence of hypersensitivity or idiosyncratic reactions to other nitrates or nitrites. \n\n No history of allergic rash. \n\n No history of significant systemic diseases. \n\n No history of psychiatric disorders or addiction to any recreational drug or drug dependence. \n\n No donation of blood within 56 days prior to study check-in. \n\n No participation in any clinical study within the past 56 days. \n\n No receipt of any prescription drugs or OTC products, with in two weeks prior to study check-in. \n\n No history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to study check-in. \n\n No family history of neurological disorders. \n\n Not consumed alcohol and xanthine containing food and beverages, cigarettes and tobacco products, for at-list 48 hours, prior to study check-in. \n\n Negative results for drugs of abuse in urine and alcohol breath analysis during check-in of each period. \n\n Not consumed grape fruit juice within the 48 hours prior to study check-in. \n\n ", - "exclusion_criteria": ": \n\n Blood pressure Systolic> 140 mm Hg and < 110 mm Hg Diastolic< 70 mm Hg > 90 mm Hg \n\n History of seizures \n\n History of alcohol consumption for more than 2 units/day. \n\n High caffeine or tobacco consumption \n\n History of difficulty with donating blood or difficulty in accessibility of veins. \n\n Any unusual or abnormal diet, for whatever reason e.g. fasting due to religious reasons. \n\n Used any pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study", - "brief_summary": "Objective:~Primary objective of the present study was to compare the single dose bioavailability of Torrent's Felodipine Extended-Release Tablets USP 10 mg and Innovator's (Mylan Pharmaceuticals Inc., USA) Felodipine Extended-Release Tablets USP 10 mg. Dosing periods were separated by a washout period of 17 days during fasting study.~Study Design:~Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study", - "NCTID": "NCT01630655" - }, - { - "brief_title": "Effects of Targeting Lower Arterial Oxygen Saturations on the Development of Control of Breathing in Very Preterm Infants", - "phase": "Phase 2; Phase 3", - "drugs": "['Oxygen saturation range', 'Oxygen saturation range']", - "drugs_list": [ - "Oxygen saturation range", - "Oxygen saturation range" - ], - "diseases": "['Development of Control of Breathing']", - "diseases_list": [ - "Development of Control of Breathing" - ], - "enrollment": "26.0", - "inclusion_criteria": "inclusion criteria: \n\n Gestational age 23 0/7 - 27 6/7 weeks \n\n Enrolled in the COT trial at the Health Sciences Centre and the St. Boniface General Hospital in Winnipeg \n\n Postnatal age between 21 days and 70 days \n\n Informed written consent obtained from at least one of the parents. \n\n ", - "exclusion_criteria": ": \n\n Need for mechanical ventilation, NCPAP or O2 \n\n Sepsis or other known causes of apnea.", - "brief_summary": "To determine whether targeting lower arterial oxygen saturations from the day of birth alters the early (first 3 months) postnatal development of the control of ventilation and the hypercapnic and hyperoxic responses in very preterm infants.", - "NCTID": "NCT00573053" - }, - { - "brief_title": "Oxygen Saturation Monitoring During Surgery", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Sleep Apnea, Obstructive']", - "diseases_list": [ - "Sleep Apnea", - "Obstructive" - ], - "enrollment": "21.0", - "inclusion_criteria": "inclusion criteria: \n\n Age greater than 21 years \n\n Patients scheduled for a procedure that requires analgesia and/or sedation by any route (intravenous, intramuscular, oral, epidural or intrathecal). \n\n Patients with an anticipated length of sedation greater than or equal to one hour. \n\n Patients in the ASA category I through III. \n\n Patients who only receive propofol, benzodiazepines, and opioids. \n\n ", - "exclusion_criteria": ": \n\n Age less than 21 years \n\n Patients whose room air oxygen saturation is <90% \n\n Patients receiving post-operative positive airway pressure support \n\n Previous allergic/contact reactions to adhesives \n\n CHF \n\n Moderate or severe valvular disease \n\n TIA/CVA \n\n Carotid stenosis or endarterectomy \n\n Anemia (HCT if available < 30%) \n\n Pulmonary hypertension \n\n Dialysis \n\n Pregnancy \n\n Patients unable to give informed consent", - "brief_summary": "Patients with Obstructive Sleep Apnea (OSA) have cyclical patterns of lower blood oxygen during sleep because of repeated episodes of upper airway obstruction that cause their breathing to stop. When these patients have surgery, anesthetic drugs may worsen these patterns of lower blood oxygen. This study monitors ten patients at high risk for OSA and ten patients at low risk for OSA during surgery. Patterns of lower oxygen saturations should arise in the high risk group but not the low risk group.", - "NCTID": "NCT01098851" - }, - { - "brief_title": "Family Spirit Study", - "phase": "", - "drugs": "['Family Spirit curriculum']", - "drugs_list": [ - "Family Spirit curriculum" - ], - "diseases": "['Substance Abuse']", - "diseases_list": [ - "Substance Abuse" - ], - "enrollment": "320.0", - "inclusion_criteria": "inclusion criteria: \n\n Native American pregnant teens or young women ages 12-22 years old at the time of conception. \n\n Women ages 20-22 years at the time of conception must be pregnant for the first time. \n\n Partners of pregnant teens must be between the ages of 12-24. \n\n Pregnant <28 weeks gestation and able to meet the requirements for completing the program in a timely way. \n\n An enrolled tribal member. \n\n Reside in the Reservation Service Unit Catchment Area and within 60 mile of the Indian Health Service Unit Headquarters. \n\n ", - "exclusion_criteria": ": \n\n Severe mental illness - schizophrenia, bipolar disorder, incapacitating depression, or Substance abuse/dependence in need of intensive and specific treatment \n\n Active legal problems - subjects will not be enrolled if they are incarcerated or if program participation has been made a condition of parole \n\n Ongoing social service involvement for abuse and neglect", - "brief_summary": "The goals of this study are to evaluate the effects of an in-home parenting education program, called Family Spirit, on parenting knowledge and skills and decreasing alcohol and substance use compared to a breast-feeding education. In addition, we will assess aspects of mother/child interaction.", - "NCTID": "NCT00356551" - }, - { - "brief_title": "High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths: Effects on Blood Oxygenation and Stability of Oxygenation", - "phase": "", - "drugs": "['HFOV combined with sigh breaths']", - "drugs_list": [ - "HFOV combined with sigh breaths" - ], - "diseases": "['Respiratory Distress Syndrome, Newborn', 'Bronchopulmonary Dysplasia', 'Ventilator Induced Lung Injury']", - "diseases_list": [ - "Respiratory Distress Syndrome", - "Newborn", - "Bronchopulmonary Dysplasia", - "Ventilator Induced Lung Injury" - ], - "enrollment": "16.0", - "inclusion_criteria": "inclusion criteria: \n\n Infants at 24-36 weeks corrected gestational age \n\n Already ventilated with high frequency ventilation \n\n Requiring FiO2=21%-70% to maintain adequate oxygen saturation. \n\n Clinical stable \n\n o i.e. ventilated on current settings for more than just a few hours with stable but not necessarily normalized blood gases or transcutaneous values and oxygen requirement. \n\n Parent(s) or guardian able and willing to provide informed consent \n\n ", - "exclusion_criteria": ": \n\n Major congenital cardiovascular or respiratory abnormalities. \n\n The attending neonatologist responsible for the baby considers one of the ventilation modes unsuitable for the infant. \n\n Poor skin integrity precluding use of transcutaneous monitoring. \n\n Lack of parental signed written informed consent. \n\n Parents under 18 years of age.", - "brief_summary": "Background:~Ventilator induced lung injury (VILI) remains a problem in neonatology. High frequency oscillatory ventilation (HFOV) provides effective gas exchange with minimal pressure fluctuation around a continuous distending pressure and therefore small tidal volume. Animal studies showed that recruitment and maintenance of functional residual capacity (FRC) during HFOV (open lung concept) could reduce lung injury.~Open lung HFOV is achieved by delivering a moderate high mean airway pressure (MAP) using oxygenation as a guide of lung recruitment. Some neonatologists suggest combining HFOV with recurrent sigh-breaths (HFOV-sigh) delivered as modified conventional ventilator-breaths at a rate of 3/min. The clinical observation is that HFOV-sigh leads to more stable oxygenation, quicker weaning and shorter ventilation. This may be related to improved lung recruitment. This has however to our knowledge not been tested in a clinical trial using modern ventilators.~Purpose, aims:~To compare HFOV-sigh with HFOV-only and determine if there is a difference in oxygenation expressed as a/A-ratio and/or stability of oxygenation expressed as percentage time with oxygen saturation outside the reference range.~To provide information on feasibility and treatment effect of HFOV-sigh to assist planning larger studies. We hypothesize that oxygenation is better during HFOV-sigh.~Methods:~Infants at 24-36 weeks corrected gestational age already on HFOV are eligible. Patients will be randomly assigned to HFOV-sigh (3 breaths/min) followed by HFOV-only or vice versa for 4 alternating 1-hours periods (2-treatment, double crossover design, each patient being its own control). During HFOV-sigh set-pressure will be reduced to keep MAP constant, otherwise HFOV will remain at pretrial settings. Outcome will be calculated from normal clinical parameters including pulx-oximetry and transcutaneous monitoring of oxygen and carbon-dioxide partial pressures.", - "NCTID": "NCT01959009" - }, - { - "brief_title": "Inhaled Prostacyclin for Adult Respiratory Distress Syndrome (ARDS) and Pulmonary Hypertension", - "phase": "", - "drugs": "['PGE1 (prostacyclin)', 'normal saline']", - "drugs_list": [ - "PGE1 (prostacyclin)", - "normal saline" - ], - "diseases": "['Adult Respiratory Distress Syndrome', 'Pulmonary Hypertension']", - "diseases_list": [ - "Adult Respiratory Distress Syndrome", - "Pulmonary Hypertension" - ], - "enrollment": "67.0", - "inclusion_criteria": "inclusion criteria: \n\n After obtaining informed consent the following patients will be included: \n\n All patients admitted to the ICU with pulmonary hypertension (mean PA > 35 mmHg). \n\n All patients in ICU with post operative pulmonary HTN (mean PA > 35 mm Hg). \n\n All patients with ARDS (PaO2/FiO2 < 200 - arterial hypoxemia, bilateral infiltrates on Chest X-ray infiltrates on CXR and a wedge < 20 mm Hg on swan ganz parameters) or signs of heart failure. \n\n ", - "exclusion_criteria": ": \n\n Patients to be excluded will be those with: \n\n Pulmonary embolus. \n\n Cor pulmonale. \n\n Ejection fraction of < 30%, wedge > 20 mm Hg. \n\n Non-intubated patients. \n\n Pediatric patients (< 16 yrs of age).", - "brief_summary": "Summary of the proposed research:~The intravenous application of prostacyclin (PGE1) or its stable analogue, iloprost, has been used to cause a decrease not only of the pulmonary but also of the systemic vascular tone. Aerosolized prostacyclin, on the other hand, can result in a selective pulmonary vasodilatation without affecting the systemic blood pressure as shown in preliminary studies/case reports. No large trials exist for this type of use of the drug so far. Furthermore, aerosolized PGI2 can improve gas exchange and pulmonary shunt in clinical settings of impaired ventilation/perfusion ratio as it occurs in adult respiratory distress syndrome (ARDS) due to the redistribution of pulmonary blood flow from non-ventilated to ventilated, aerosol accessible lung regions. Therefore, the investigators propose to carry out a prospective, double blinded, randomized trial to show that the nebulized iloprost decreases pulmonary hypertension selectively and improves oxygenation in ARDS.", - "NCTID": "NCT00314548" - }, - { - "brief_title": "The Effects of Sound Energy on Pulmonary Gas Exchange", - "phase": "", - "drugs": "['Induction of sound waves in lungs by sonic oscillator']", - "drugs_list": [ - "Induction of sound waves in lungs by sonic oscillator" - ], - "diseases": "['Respiratory Failure']", - "diseases_list": [ - "Respiratory Failure" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy male or female volunteers in the age group. \n\n ", - "exclusion_criteria": ": \n\n Any acute or chronic cardiopulmonary disorder including a simple common cold.", - "brief_summary": "Study of the effects of sonic pressure oscillations on pulmonary gas exchange with added dead space.", - "NCTID": "NCT02447731" - }, - { - "brief_title": "Dental Support Device During Breastfeeding as a Mean for Pain Control", - "phase": "Phase 3", - "drugs": "['Leboride']", - "drugs_list": [ - "Leboride" - ], - "diseases": "['Breastfeeding']", - "diseases_list": [ - "Breastfeeding" - ], - "enrollment": "1500.0", - "inclusion_criteria": "inclusion criteria: \n\n Maternal age 18-45 years. \n\n Normal vital signs. \n\n ", - "exclusion_criteria": ": \n\n Contraindications for breastfeeding. \n\n Significant systemic disease that cause pain or require chronic pain relief.", - "brief_summary": "Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one.~This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.", - "NCTID": "NCT02399774" - }, - { - "brief_title": "Using Nasal High Flow From Birth in Premature Infants - a Pilot Study", - "phase": "", - "drugs": "['Vapotherm Precision Flow']", - "drugs_list": [ - "Vapotherm Precision Flow" - ], - "diseases": "['Premature Birth']", - "diseases_list": [ - "Premature Birth" - ], - "enrollment": "28.0", - "inclusion_criteria": "inclusion criteria: \n\n Parental consent \n\n 24+0 to 30+0 weeks(agreed dates) gestation born alive \n\n Breathing spontaneously at birth or soon after with minimal resuscitation \n\n Oxygen saturations >90% by 5 minutes \n\n ", - "exclusion_criteria": ": \n\n No parental consent \n\n Born in poor condition and unlikely to survive \n\n Needing resuscitation including intubation and/or chest compressions \n\n Not breathing and thus needing intubation \n\n Oxygen saturations <90% by 5 minutes \n\n <24 weeks gestation \n\n >30 weeks gestation", - "brief_summary": "Recent large studies have shown that not all premature babies need to be intubated (have a breathing tube inserted) and ventilated, nor do they all need to be given lung surfactant routinely. Those studies showed that even very small babies can be safely supported using nasal Continuous Positive Airway Pressure (nCPAP) which is applied tightly to the nose using nasal prongs. This is a type of noninvasive ventilation (NIV) so that the babies continue to breath, albeit with additional support to reduce their work of breathing. However nCPAP has some drawbacks, including that it can cause skin damage to the nose, and that the heating and humidification of the gas is not always sufficient. We have been using, for over 5 years, a different system to support babies after routine intubation. This is another type of noninvasive ventilation called nasal High Flow (nHF) for which we use a Vapotherm Precision Flow device. Published trials show that it is at least as effective as nCPAP to provide NIV and to prevent the subsequent need for intubation and/or surfactant. However nHF is superior to nCPAP in respect it does not cause nose damage and its heating and humidification is excellent. This pilot study aims to describe and evaluate the use of nHF, using a standard commercially available system (Precision Flow, Vapotherm Inc.), from birth, in babies born less than 30 completed weeks gestation, with a view to avoiding intubation and ventilation. This study is important to establish the feasibility of using nHF immediately after birth.", - "NCTID": "NCT01991886" - }, - { - "brief_title": "Patients With Pulmonary Hypertension or Interstitial Lung Disease at Altitude - Effect of Oxygen on Breathing and Sleep", - "phase": "Phase 4", - "drugs": "['Moderate altitude sojourn', 'Low altitude sojourn', 'Oxygen', 'Sham oxygen (room air)']", - "drugs_list": [ - "Moderate altitude sojourn", - "Low altitude sojourn", - "Oxygen", - "Sham oxygen (room air)" - ], - "diseases": "['Precapillary Pulmonary Hypertension', 'Interstitial Lung Disease']", - "diseases_list": [ - "Precapillary Pulmonary Hypertension", - "Interstitial Lung Disease" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Precapillary pulmonary hypertension, or interstitial lung disease. \n\n New York Heart Association class 2-3. \n\n Residence at low altitude (<800m). \n\n ", - "exclusion_criteria": ": \n\n Unstable or exacerbated condition \n\n Very severe pulmonary hypertension or interstitial lung disease, New York Heart Association class 4 \n\n requirement for oxygen therapy at low altitude residence \n\n hypoventilation \n\n more than mild or unstable cardiovascular disease \n\n use of drugs that affect respiratory center drive \n\n internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day), inability to perform 6 min walk test. \n\n previous intolerance to moderate altitude (<2600m). \n\n Exposure to altitudes >1500m for >2 days within the last 4 weeks before the study. \n\n Pregnant or nursing patients", - "brief_summary": "The purpose of this study is to investigate the effect of travelling to moderate altitude and of nocturnal oxygen therapy during a stay at moderate altitude on breathing and sleep of patients with pulmonary hypertension or with interstitial lung disease.", - "NCTID": "NCT02150616" - } - ], - "1": [ - { - "brief_title": "Postpartum Anemia and Postpartum Depression", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Postpartum Depression']", - "diseases_list": [ - "Postpartum Depression" - ], - "enrollment": "103.0", - "inclusion_criteria": "inclusion criteria: \n\n Women after term elective cesarean section \n\n ", - "exclusion_criteria": ": \n\n age < 16 years, preterm (< 37 weeks) delivery, multiple gestation, symptomatic anemia necessitating blood transfusion, significant fetal anomalies or infant not discharged with mother for other reason, preexisting severe chronic maternal illness, preexisting maternal depression and/or current use of antidepressants, other psychiatric illness (e.g. bipolar disease, schizophrenia) or preexisting hemoglobinopathy", - "brief_summary": "Postpartum anemia (PPA) and Postpartum depression (PPD) are common afflictions affecting women after childbirth. Both disorders have a significant impact on women's health and functional status. Despite common symptoms and characteristics, a link between these entities has not been adequately studied. The objective of this study is to determine whether postpartum anemia is an independent risk factor for the development of postpartum depression. This prospective cohort study will include all women delivered by elective term cesarean delivery. Hemoglobin and iron levels will be measured, standardized questionnaires for assessment of PPD, functional status and lactation will be administered before discharge and at 3 & 6 weeks post partum. Hemoglobin levels at each time point will be analyzed for correlation with depressive symptoms, functional status and lactation success.", - "NCTID": "NCT00782912" - }, - { - "brief_title": "Impact of the BB Box System on Postpartum Maternal Anxiety, Post Traumatic Stress and Mother-child Relationships", - "phase": "", - "drugs": "['BB Box available', 'No BB Box']", - "drugs_list": [ - "BB Box available", - "No BB Box" - ], - "diseases": "['Stress Disorders, Post-Traumatic', 'Anxiety']", - "diseases_list": [ - "Stress Disorders", - "Post-Traumatic", - "Anxiety" - ], - "enrollment": "59.0", - "inclusion_criteria": "inclusion criteria: \n\n The patient must have given his/her informed and signed consent \n\n The patient must be insured or beneficiary of a health insurance plan \n\n The patient is available for 12 months of follow up \n\n The patient has given birth this day to a premature child (< 36 weeks of gestation and/or < 2 kg birthweight) \n\n Separation of child and mother since birth \n\n ", - "exclusion_criteria": ": \n\n The patient or baby is participating in another study, excepting the studies OASIS or PROM8736 \n\n The patient or baby is in an exclusion period determined by a previous study \n\n The patient is under judicial protection, under tutorship or curatorship \n\n The patient or father refuses to sign the consent \n\n It is impossible to correctly inform the patient \n\n Preexisting maternal psychiatric pathology \n\n Major or lethal poly-malformation syndrome \n\n Severe pathologies that threaten child survival: pulmonary hypertension, septic shock, anoxic-ischemic brain \n\n Any emergency situation preventing patient involvement \n\n Mother and/or child not hospitalized at the N\u00eemes University Hospital \n\n Death of the patient or child during the study", - "brief_summary": "The main objective of this study is to compare the degree of maternal anxiety at Day 3 postpartum in mothers who did or did not have access to a video communication system (BB-Box system) from the time of initial separation with their baby.", - "NCTID": "NCT01566058" - }, - { - "brief_title": "The Effect of Early Versus Traditional Follow-Up on Breastfeeding Rates at 6 Months", - "phase": "", - "drugs": "['Postpartum follow up appointment 2-3 weeks after delivery', 'Postpartum follow up 6-8wk after delivery']", - "drugs_list": [ - "Postpartum follow up appointment 2-3 weeks after delivery", - "Postpartum follow up 6-8wk after delivery" - ], - "diseases": "['Pregnancy', 'Breastfeeding', 'Contraception', 'Cervical Cancer', 'Postpartum Depression']", - "diseases_list": [ - "Pregnancy", - "Breastfeeding", - "Contraception", - "Cervical Cancer", - "Postpartum Depression" - ], - "enrollment": "344.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 or above at time of delivery \n\n Delivery of live born infant at estimated gestational age (EGA) \u226537wk \n\n Postpartum primiparous patients within the first 48 hours after delivery \n\n Patient intent to breastfeed \n\n Breastfeeding initiated within the first 48 hours of delivery and/or prior to hospital discharge (whichever occurs first) \n\n Infant is continuously rooming in with mother from the time of delivery \n\n English-speaking \n\n Able to read and complete surveys \n\n No anticipated discharge from military system, Tricare benefits, or move planned in the upcoming 6 months \n\n Willing to render informed consent \n\n ", - "exclusion_criteria": ": \n\n Patients delivered by the Family Medicine Department (relatively small number in our population who are not followed postpartum by the Department of Obstetrics and Gynecology) \n\n Any condition deemed by patient provider to be an absolute contraindication to breastfeeding \n\n Maternal HIV/AIDS \n\n Planned use of radioactive or chemotherapeutic medications or medication for other medical problems which is contraindicated for delivery \n\n Known fetal factor that would impair breastfeeding \n\n Fetal mid-facial defects \n\n Known fetal chromosomal abnormality \n\n Known fetal conditioning resulting in fetal hypotonia \n\n Labor and Delivery complications \n\n Maternal separation from infant during the first 48 hours postpartum (such as maternal ICU admission, infant NICU admission)", - "brief_summary": "The study's purpose is to determine if early (2-3 week) versus traditional (6-8 week) postpartum follow up is associated with a higher rate of breastfeeding at 6 months. The study's hypothesis is that follow up at 2-3 weeks postpartum is associated with a higher rate of breastfeeding 6 months postpartum.", - "NCTID": "NCT02221895" - }, - { - "brief_title": "Computed Tomography CT Venography During Postpartum Venous Thromboembolism", - "phase": "", - "drugs": "['computed tomography venography']", - "drugs_list": [ - "computed tomography venography" - ], - "diseases": "['Pulmonary Thromboembolism']", - "diseases_list": [ - "Pulmonary Thromboembolism" - ], - "enrollment": "125.0", - "inclusion_criteria": "inclusion criteria: \n\n Women with clinically suspected pulmonary embolism (PE) during the first 6 weeks postpartum, without any sign of severe PE (shock, hypotension), referred for CT angiography \n\n Absence of contraindication to iodinated contrast medium injection (Previous allergic reaction to iodinated contrast medium, renal insufficiency with creatine clearance less than 30mL/mn, uncontrolled hyperthyroidism) \n\n Age > 18 years \n\n Health insurance \n\n Possibility to have 3-month follow-up \n\n Obtention of written informed consent (ability to give consent) \n\n ", - "exclusion_criteria": ": \n\n Anticoagulation at therapeutic dosage for another reason than the suspicion of PE for more than 72 hours \n\n New pregnancy (In case of any doubt after medical history review, \u03b2HCG blood test must be realized to ensure patient's pregnancy status) \n\n Contrast medium extravasation during injection \n\n CTA or CTV not performed according to the study requirements", - "brief_summary": "The purpose of this study is to determine whether systematically performing computed tomography (CT) venography (i.e a CT acquisition of the pelvis and of the lower limbs, during the venous phase of opacification) in addition to thoracic CT angiography in women with suspected postpartum pulmonary embolism (PE) results in a gain in venous thromboembolism detection rate.", - "NCTID": "NCT02616991" - }, - { - "brief_title": "A Comparison Between Intravenous Iron Sucrose to Its Combination With Oral Iron Supplements for the Treatment of Postpartum Anemia", - "phase": "", - "drugs": "['Iron sucrose 500 mg', 'Iron bisglycinate 60 mg']", - "drugs_list": [ - "Iron sucrose 500 mg", - "Iron bisglycinate 60 mg" - ], - "diseases": "['Postpartum Anemia']", - "diseases_list": [ - "Postpartum Anemia" - ], - "enrollment": "158.0", - "inclusion_criteria": "inclusion criteria: \n\n Women above 18 years old after giving birth \n\n Women who suffer from iron deficiency anemia, defined as hemoglobin< 9.5 g/dl without one of the conditions that are described in the ", - "exclusion_criteria": " \n\n ", - "brief_summary": "This study is aimed to compare the efficacy of two mode of iron administration to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement.", - "NCTID": "NCT02458625" - }, - { - "brief_title": "Carbetocin at Elective Cesarean Delivery Part 4", - "phase": "", - "drugs": "['Carbetocin']", - "drugs_list": [ - "Carbetocin" - ], - "diseases": "['Postpartum Hemorrhage']", - "diseases_list": [ - "Postpartum Hemorrhage" - ], - "enrollment": "110.0", - "inclusion_criteria": "inclusion criteria: \n\n Elective cesarean delivery under spinal anesthesia. \n\n Written informed consent to participate in this study. \n\n Term pregnancy \n\n ", - "exclusion_criteria": ": \n\n Refusal to give written informed consent. \n\n Allergy or hypersensitivity to carbetocin or oxytocin. \n\n Conditions that predispose to uterine atony and postpartum hemorrhage, such as placenta previa, multiple gestation, preeclampsia, eclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis. \n\n Hepatic, renal, and vascular disease.", - "brief_summary": "PostPartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly used uterotonic drug to prevent and treat PPH in North America. However oxytocin has a very short duration of action, requiring a continuous infusion to achieve sustained uterotonic activity. Moreover large doses are associated with adverse effects like hypotension, nausea, vomiting, dysrhythmias and ST changes. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recommended a single dose of 100 mcg of carbetocin at elective cesarean delivery to promote uterine contraction. In three studies recently performed at Mount Sinai Hospital, the investigators have found no difference in uterine contractility between the doses of 20- 120 mcg carbetocin and that the ED90 is 14.8 mcg. Thus a larger trial comparing the minimum effective dose determined in the previous three trials with the standard 100 mcg dose is necessary to confirm these findings.", - "NCTID": "NCT02264769" - }, - { - "brief_title": "Phase I Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism", - "phase": "Phase 1", - "drugs": "['nitric oxide']", - "drugs_list": [ - "nitric oxide" - ], - "diseases": "['Pulmonary Embolism']", - "diseases_list": [ - "Pulmonary Embolism" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n inclusion criteria: \n\n Diagnosis of acute PE requires symptoms of PE present <14 days with CT angiography interpreted as positive for acute PE. Initial evaluation for PE must be predicated upon the investigation of new or unexplained cardiopulmonary or chest-related clinical features consistent with PE, including shortness of breath, chest pain, respiratory distress, dizziness, unexplained tachypnea, tachycardia, syncope, cough or hemoptysis. All patients must have CT chest angiography with <2 mm collimation,(36) with or without indirect venography. Pulmonary arterial opacification will be achieved with power injection of non-ionic, low osmolar contrast in an antecubital vein with a timing run; the pitch, voltage, gantry speed and other technical details appropriate for each scanner.(37;38) Images will be interpreted as positive for intrapulmonary arterial filling defect consistent with acute PE using our published definitions(37;38) by a board-certified radiologist with specialty training in body CT or emergency medicine imaging in all cases. \n\n SBP (SBP)> 89 mm Hg at the time of enrollment. We will allow enrollment for a patient with an SBP < 90 mm Hg prior to enrollment, or a patient with a SBP>80 mm Hg, if the patient has a documented or patient-identified history of low blood pressure and has no symptoms of shock, as described by Jones et al.(39) \n\n SaO2% >80% at time of enrollment. \n\n Patients must have a Borg score greater than 4/10. \n\n ", - "exclusion_criteria": ": \n\n Altered mental status such that they are unable to provide consent. \n\n Inability to use a nasal cannula or face mask (e.g., anatomic defect) \n\n Supplemental oxygen requirement greater than can be administered via nasal cannula or face mask in order to maintain SaO2 >80%. \n\n Pregnancy \n\n Pneumothorax with decompression \n\n A serum mtHb greater than 10% \n\n Concurrent therapies including: \n\n Viagra\u00ae (sildenafil) use within the past 24 hours \n\n Levitra\u00ae (vardenafil) use within the past 24 hours \n\n Cialis\u00ae (tadalafil) use within the past 72 hours \n\n Use nitroprusside or nitroglycerine with in the past 4 hours \n\n Concomitant use of pressor or inotropic agents \n\n Use of fibrinolytic agent with in the past 14 days \n\n Use of nitrates within the past 24 hours", - "brief_summary": "This study will test the hypothesis that patients with acute PE and dyspnea can safely inhale NO. The secondary hypothesis is that patients who are blinded to the inhaled NO concentration will sustain subjective improvement in their perception of dyspnea based upon their reported Borg dyspnea score, during inhalation of NO.~Specific aims~Test if patients with acute PE and shortness of breath of severity \u2265 5 on a 0-10 scale called the Borg score can have inhaled nitric oxide administered via nasal cannula or face mask in a titration protocol that increases concentration by 5 ppm in 5 min steps to a maximum of 25 ppm.~We will measure the number of patients who meet an absolute safety endpoint during titration. An absolute safety endpoint requires execution of a rapid weaning protocol (2 ppm decrease per minute to 0 ppm).~Absolute safety endpoints: Two consecutive SBP measurements more than one min apart with both readings < 80 mm Hg;SaO 2 <80% for more than 15 seconds; Patient deterioration as defined by: Clinical decision for need of inotropic or pressor support for any reason, seizure, new altered mental status, focal neurological signs suggestive of cerebral ischemia, evidence of myocardial ischemia, protracted vomiting.~Test if the patient-reported Borg score decreases with administration of NO. Patients will not be told any details about the timing of the titration and will not be made aware of their iNO concentration when the Borg score is assessed.", - "NCTID": "NCT00848731" - }, - { - "brief_title": "Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn", - "phase": "Phase 2", - "drugs": "['Experimental group: Budicort by Inhalation', 'placebo']", - "drugs_list": [ - "Experimental group: Budicort by Inhalation", - "placebo" - ], - "diseases": "['Transient Tachypnea of the Newborn']", - "diseases_list": [ - "Transient Tachypnea of the Newborn" - ], - "enrollment": "56.0", - "inclusion_criteria": "inclusion criteria: \n\n Late preterm and term infants (post-menstrual age \u2265 34 weeks) delivered by cesarean section or vaginal delivery \n\n Diagnosis of TTN \n\n Parents signed informed consent \n\n ", - "exclusion_criteria": ": \n\n Meconium aspiration syndrome \n\n Respiratory distress syndrome \n\n Congenital heart disease \n\n Non respiratory disorders causing tachypnea", - "brief_summary": "Transient Tachypnea of the Newborn (TTN) is a common respiratory disorder affecting late preterm and term babies caused by lung edema resulting from delayed absorption of fetal alveolar lung fluid.~The investigators hypothesize that ENAC expression will be up-regulated as a result of administration of corticosteroids. This effect will lead to enhanced absorption of fetal lung fluid finally treating TTN. The aim of our study will be to evaluate whether inhaled corticosteroids reduce respiratory distress and morbidity in late preterm and term neonates presenting with TTN.", - "NCTID": "NCT01858129" - }, - { - "brief_title": "Comparison of Pharyngeal Oxygen Delivery by Different Oxygen Masks", - "phase": "", - "drugs": "['Oxygen administration']", - "drugs_list": [ - "Oxygen administration" - ], - "diseases": "['Hypoxemia', 'Trauma', 'Acute Myocardial Infarction']", - "diseases_list": [ - "Hypoxemia", - "Trauma", - "Acute Myocardial Infarction" - ], - "enrollment": "14.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 to 70 years of age \n\n Male and female volunteers \n\n ASA physical status I, II and III \n\n Capable and willing to provide written informed consent in English \n\n ", - "exclusion_criteria": ": \n\n Acute cardiopulmonary disease, as defined by blood pressure greater than 150/90, HR greater than 120 and room air oxygen saturation less than 92. \n\n Allergy to lidocaine or adhesive tape \n\n History or physical exam finding of nasal polyps \n\n Currently taking oral or parenteral anticoagulant medications (other than aspirin) \n\n History of frequent nose bleeds \n\n Current symptoms of nasal congestion \n\n Physical examination findings of rales or wheezing \n\n Facial hair that prevents forming a seal with an anesthesia mask", - "brief_summary": "The intent of this study is to determine the difference in pharyngeal oxygen concentration in patients who have a natural airway (not intubated) using commonly available oxygen delivery systems.~The investigators will test the hypothesis that oxygen concentration during the period of inspiration (FiO2) in the pharynx is dependent on oxygen delivery system design, even at high flow (15 liters/minute) oxygen delivery. Specific measurements include oxygen concentration at subjects' lips and pharynx when breathing 100% oxygen and room air via a simple mask, non-rebreather mask, OxyMaskTM, and anesthesia mask with headstrap and Jacson Rees circuit.~A mean difference of 10% pharyngeal FiO2 between any of the masks will be considered clinically important. The expected standard deviation of the within-subject FiO2 is 3.5%. With a significance criterion of 0.05, 10 subjects would provide more than 90% power to detect a mean difference of 10%.", - "NCTID": "NCT02523586" - }, - { - "brief_title": "Study of Diagnosis and Pathophysiology of Pulmonary Embolism (APE 1 Trial)", - "phase": "", - "drugs": "['Scintigraphic interpretation']", - "drugs_list": [ - "Scintigraphic interpretation" - ], - "diseases": "['Pulmonary Embolism', 'Right Heart Strain']", - "diseases_list": [ - "Pulmonary Embolism", - "Right Heart Strain" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria: \n\n Referred from clinical departments at Odense University Hospital \n\n Referred to the Departments of Nuclear Medicine or Radiology for diagnostic evaluation of suspected pulmonary embolism \n\n Referred for lung scintigraphy, spiral computer tomography, or pulmonary angiography \n\n ", - "exclusion_criteria": ": \n\n Age below 18 \n\n Contrast allergy \n\n Pregnancy \n\n S-Creatinine above 200 micromol/L \n\n Metformin treatment \n\n Fibrinolytic or surgical therapy between examinations \n\n No informed consent \n\n Withdrawn consent \n\n Failed logistics (more than 24 hours between examinations) \n\n No conclusive pulmonary angiography", - "brief_summary": "The purpose of this study is to~investigate which method and criterion for diagnosing pulmonary embolism is the best and~determine the relationship between blood vessel constriction and clot size in patients developing heart failure", - "NCTID": "NCT00302601" - }, - { - "brief_title": "Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation", - "phase": "Phase 4", - "drugs": "['100% oxygen breathing', '15% oxygen in N2 breathing', '12% oxygen in N2 breathing']", - "drugs_list": [ - "100% oxygen breathing", - "15% oxygen in N2 breathing", - "12% oxygen in N2 breathing" - ], - "diseases": "['Retinal Oxygenation', 'Retinal Blood Flow']", - "diseases_list": [ - "Retinal Oxygenation", - "Retinal Blood Flow" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Men and women aged between 18 and 35 years \n\n Nonsmokers \n\n Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant \n\n Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant \n\n Normal ophthalmic findings, ametropy < 3 Dpt. \n\n ", - "exclusion_criteria": ": \n\n Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive) \n\n Symptoms of a clinically relevant illness in the 3 weeks before the first study day \n\n Presence of any form of anemia \n\n Blood donation during the previous 3 weeks \n\n Pregnancy", - "brief_summary": "Adequate perfusion and oxygenation is essential for the function of the inner retina. Although it is known that oxygen tension is very well autoregulated in the retina, the physiological mechanisms behind this regulation process are not fully explored. The development of new instruments for the non-invasive measurement of oxygen tension in retinal vessels now allows for the more precise investigation of these physiological processes. The current study seeks to evaluate the retinal oxygen saturation in healthy subjects while breathing different oxygen mixtures to achieve a hypoxic and a hyperoxic state.", - "NCTID": "NCT01692821" - } - ], - "2": [ - { - "brief_title": "The Impact of Creative Interventions on Symptoms of Postnatal Depression (Cohort Study)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Depression, Postpartum']", - "diseases_list": [ - "Depression", - "Postpartum" - ], - "enrollment": "2558.0", - "inclusion_criteria": "inclusion criteria: \n\n Women who are more than 28 weeks pregnant OR up to 9 months post-birth \n\n ", - "exclusion_criteria": ": \n\n Outside the limits of the number of weeks pregnant/post birth \n\n Living outside England \n\n Refusal to participate", - "brief_summary": "Post-natal depression (PND) is anticipated to affect 12.9% of new mothers with at least 75,000 cases per year in the UK alone. However, despite this, there is currently a worrying lack of support for new mothers, with data suggesting that 64% of healthcare trusts in the UK do not have a strategy for treating PND, and flaws in the current pharmacological and psychological treatment models. Consequently, research into promising psychosocial interventions such as music is critical to developing new paradigms for treating PND.~This project is an ambitious programme of research that investigates links between the mental health of women in the later stages of pregnancy and first 9 months post birth and their use of psychosocial interventions including music.", - "NCTID": "NCT02526433" - }, - { - "brief_title": "BNP Testing in Patients With SOB on Presentation to ED", - "phase": "Phase 1", - "drugs": "['BNP test']", - "drugs_list": [ - "BNP test" - ], - "diseases": "['Heart Failure, Congestive']", - "diseases_list": [ - "Heart Failure", - "Congestive" - ], - "enrollment": "600.0", - "inclusion_criteria": "inclusion criteria: \n\n We plan to include all patients presenting to the ED with shortness of breath that are over 40 years old and present with an emergency department triage category of 3 or higher. \n\n ", - "exclusion_criteria": ": \n\n Patients presenting with a traumatic cause of dyspnea, patients with severe renal disease (serum creatinine level of more than 250 micro mmol/L, patients with cardiogenic shock, and patients who have an early transfer to another hospital (within 24 hrs) will be excluded.", - "brief_summary": "A trial to examine whether a new heart failure blood test can improve the outcome of patients presenting to the Emergency Department with shortness of breath.~We hypothesise that a BNP test performed in real-time in patients presenting to the Emergency Department with shortness of breath will help identify additional patients with CHF and consequently to change practice and allow more patients to recieve correct treatment earlier.", - "NCTID": "NCT00163709" - } - ] - }, - { - "patient_id": "sigir-201414", - "patient": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", - "0": [ - { - "brief_title": "Delirium in the Emergency Department: Novel Screening", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Delirium']", - "diseases_list": [ - "Delirium" - ], - "enrollment": "498.0", - "inclusion_criteria": "inclusion criteria: \n\n 65 years of age or greater \n\n In the Emergency Department for less than 12 hour at the time of enrollment \n\n ", - "exclusion_criteria": ": \n\n Severe mental retardation or dementia \n\n Baseline communication barriers such as aphasia, deafness, blindness, or who are unable to speak English \n\n Refusal of consent \n\n Previous enrollment \n\n Comatose \n\n Out of the hospital before the assessments are completed", - "brief_summary": "Delirium is an acute confusional state characterized by altered or fluctuating mental status, inattention, and either disorganized thinking or an altered level of consciousness. This form of organ dysfunction occurs in up to 10% of older emergency department (ED) patients and is associated with worsening mortality, prolonged hospital length of stay, higher health care costs, and accelerated functional and cognitive decline. Despite the negative consequences of delirium, the majority of cases are unrecognized by emergency physicians because it is not routinely screened for. In an effort to facilitate delirium screening, the investigators sought to validate three brief delirium assessments in the ED setting.", - "NCTID": "NCT01162343" - }, - { - "brief_title": "Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)", - "phase": "Phase 1", - "drugs": "['Low pressure hyperbaric oxygen therapy', 'Low pressure hyperbaric oxygen therapy']", - "drugs_list": [ - "Low pressure hyperbaric oxygen therapy", - "Low pressure hyperbaric oxygen therapy" - ], - "diseases": "['TBI (Traumatic Brain Injury)', 'Post Concussion Syndrome', 'Post Traumatic Stress Disorder', 'Chronic Post Traumatic Stress Disorder']", - "diseases_list": [ - "TBI (Traumatic Brain Injury)", - "Post Concussion Syndrome", - "Post Traumatic Stress Disorder", - "Chronic Post Traumatic Stress Disorder" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults, 18-65 years old \n\n One or more mild-moderate TBI's characterized by loss of consciousness due to blast injury that is a minimum of one year old and occurred after 9/11/2001 \n\n Absence of acute cardiac arrest or hemorrhagic shock at time of TBI. \n\n Absence of intracranial neurosurgery post-TBI \n\n Disability Rating Scale of 0-3 \n\n Negative Michigan Alcohol Screening Test (MAST) \n\n Negative Drug Abuse Screening Test (DAST) \n\n Negative urine toxicology screen for drugs of abuse \n\n Negative pregnancy test in females \n\n Otherwise good health \n\n Less than 90% on the Percent Back to Normal Rating Scale \n\n ", - "exclusion_criteria": ": \n\n Pulmonary disease that precludes HBOT \n\n Unstable medical conditions that are contraindicated in HBOT \n\n Severe confinement anxiety \n\n Pregnancy \n\n Other pre-TBI neurological diagnoses \n\n Pre or post TBI history of substance abuse \n\n Pre or post TBI history of alcoholism. \n\n Participation in another experimental trial with active intervention. \n\n High probability of inability to complete the experimental protocol. \n\n Previous HBOT \n\n History of hospitalization for past TBI, stroke, nonfebrile seizures, or any seizure history other than seizure at the time of TBI \n\n Past or current history of mental retardation (baseline FSIQ < 71. \n\n Pre/post-TBI history of systemic illness with impact on CNS (P.I.'s decision)", - "brief_summary": "This is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric oxygen therapy can improve cognition and brain imaging in subjects with either chronic mild-moderate traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.", - "NCTID": "NCT00760734" - }, - { - "brief_title": "Treatment of Delirium in the Elderly With Donepezil: a Double-blind, Randomized, Placebo-controlled Clinical Trial", - "phase": "Phase 4", - "drugs": "['Donepezil']", - "drugs_list": [ - "Donepezil" - ], - "diseases": "['Elderly', 'Delirium of Unknown (Axis III) Etiology', 'Intensive Care (ICU) Myopathy']", - "diseases_list": [ - "Elderly", - "Delirium of Unknown (Axis III) Etiology", - "Intensive Care (ICU) Myopathy" - ], - "enrollment": "19.0", - "inclusion_criteria": "inclusion criteria: \n\n Over 60 year old \n\n Delirium according to the CAM-ICU (Confusion Assessment Method for Intensive Care Unit) \n\n informed consent (legal representatives) \n\n ", - "exclusion_criteria": ": \n\n unable to swallow pills \n\n previous allergy to donepezil \n\n Atrioventricular block of 2nd and 3nd degree", - "brief_summary": "Nowadays features for the diagnosis of delirium are:~Disturbance of consciousness (i.e. reduced clarity of environment awareness) with reduced ability to focus, sustain or shift attention;~A change in cognition (such as memory deficit, disorientation, language disturbance) or the development of a perceptual disturbance that is not better accounted for by a pre-existing or evolving dementia;~The disturbance develops over a short period of time (usually hours to days) and its severity fluctuates during the course of the day;~There is evidence from the history, physical examination, or laboratory findings that the disorder is caused by the direct physiological consequences of a general medical condition, substance intoxication or substance withdrawal.~Treatment of underlying clinical disease is important to remit the delirium. However, these procedures alone are not enough to remit the delirium early and to prevent sequels. There is a need for a specific and faster strategy to treat the delirium.~The investigators want to test the hypothesis that an Anticholinesterase Inhibitor (donepezil) can reduce the duration of the delirium.", - "NCTID": "NCT01633593" - }, - { - "brief_title": "Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Me-chanical Ventilation - Effects on Cognitive Function", - "phase": "", - "drugs": "['Non-sedation', 'Control: Sedation']", - "drugs_list": [ - "Non-sedation", - "Control: Sedation" - ], - "diseases": "['Delirium', 'Cognition Disorders']", - "diseases_list": [ - "Delirium", - "Cognition Disorders" - ], - "enrollment": "205.0", - "inclusion_criteria": "inclusion criteria: \n\n Endotracheally intubated \n\n Expected time on ventilator > 24 hours \n\n Age \u2265 18 years \n\n Informed consent \n\n ", - "exclusion_criteria": ": \n\n Severe head trauma where therapeutic coma is indicated \n\n Therapeutic hypothermia where therapeutic coma is indicated \n\n Status epilepticus where therapeutic coma is indicated \n\n Patient has participated in the study before \n\n Patient is transferred from another ICU with length of stay > 48 hours \n\n Patient is comatose at admission \n\n PaO2/FiO2 \u2264 9, if sedation is necessary for oxygenation \n\n Patient does not speak Danish, swedish or norwegian at a reasonable level", - "brief_summary": "Through many years, the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation. However, preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level in these patients. The NONSEDA trial is an investigator-initiated, randomised, clinical, parallel-group, multinational, superiority trial designed to include 700 patients from at least six ICUs in Denmark, Norway and Sweden, comparing no sedation with sedation and a daily wake-up trial during mechanical ventilation. This is a substudy of the NONSEDA trial, concerning 250 patients included at trialsite Kolding, Denmark. The aim of the substudy is to assess the effects of no sedation on delirium during admission and cognitive function after discharge from ICU.~Our hypothesis is that critically ill patients who are not sedated during mechanical ventilation will have better cognitive function after discharge.", - "NCTID": "NCT02035436" - }, - { - "brief_title": "Amyloid and Tauopathy PET Imaging in Acute and Chronic Traumatic Brain Injury", - "phase": "", - "drugs": "['Amyvid PET Scan', 'T807 PET scan']", - "drugs_list": [ - "Amyvid PET Scan", - "T807 PET scan" - ], - "diseases": "['Traumatic Brain Injury', 'Chronic Traumatic Encephalopathy', 'Mild Cognitive Impairment']", - "diseases_list": [ - "Traumatic Brain Injury", - "Chronic Traumatic Encephalopathy", - "Mild Cognitive Impairment" - ], - "enrollment": "46.0", - "inclusion_criteria": "inclusion criteria: \n\n males between 40 to 85 years of age \n\n individuals who participated in contact sports (e.g., active and retired NFL players, NHL players, boxers, NCAA athletes) and other individuals (including but not limited to veterans, breachers, or law enforcement officials with multiple blast exposures) who all have a history of one or more concussions and have a memory or cognitive complaint \n\n individuals with Mild Cognitive Impairment (MCI) and no history of concussion or TBI \n\n healthy controls with no history of head injury and no current cognitive or memory problems \n\n all participants require a study partner, who is well acquainted with the participant, to answer questions either in person or over the telephone about the individuals' activities of daily living, and to corroborate cognitive problems and past history of brain injury \n\n ", - "exclusion_criteria": ": \n\n any significant neurological disease, such as Alzheimer's disease, Parkinson's disease, vascular dementia, Huntington's disease, Pick's disease, Lewy Body Dementia, frontotemporal dementia, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, or multiple sclerosis \n\n any significant systemic illness or unstable medical condition, including: uncontrolled diabetes mellitus, uncorrected hypothyroidism or hyperthyroidism, or systemic cancer \n\n a history of schizophrenia or psychosis, alcohol or substance abuse or dependence within the past 6 months \n\n clinically significant impairment of liver or renal function \n\n significant cerebrovascular disease \n\n impairment of visual or auditory acuity sufficient to interfere with completion of study procedures \n\n education level < 10 years \n\n any subjects with a history of risk factors for Torsades de Pointes, or subjects taking drugs known to prolong the QT interval \n\n subjects who have had 2 or more PET scans within the past year, or other significant exposure to radiation (i.e., radiation therapy)", - "brief_summary": "The potential long-term effects of Traumatic Brain Injury (TBI) are poorly understood. Repeated concussions have been associated with an elevated incidence of Alzheimer's disease (AD) along with a reduced age of onset. As repetitive TBI has been studied, a syndrome has now been identified: chronic traumatic encephalopathy (CTE). There are growing concerns about the long-term neurologic consequences of head impact exposure from routine participation in contact sports (e.g., boxing, football). Brain autopsies of athletes with confirmed CTE have demonstrated tau-immunoreactive neurofibrillary tangles and neuropil threads (known as tauopathy). The relationship between exposure to repetitive head impact and the subsequent development of chronic neurodegenerative disease has not been established. Further, as the diagnosis of CTE (defined by the presence of tauopathy) is presently made after death at autopsy, clinical tools and biomarkers for detecting it remain to be defined.~With the advent of FDA-approved PET amyloid imaging, clinicians and researchers are now able to estimate plaque density in the brains of living patients. However, there are critical limitations to amyloid imaging. Current evidence suggests that markers of the presence and severity of tauopathy may be able to address these limitations. The study will utilize both [18F] Florbetapir and [18F]-T807 PET imaging to investigate amyloid and tau accumulation in subjects with a history of concussions. In order to determine whether problems with cognition and memory are seen within the populations defined for the study, the researchers will administer a core battery of neurocognitive testing. This battery will assess cognitive abilities commonly affected by TBI, including processing speed, reaction time, new problem-solving, executive functions, attention and concentration, and learning and memory. These tests, in conjunction with the imaging, will be able to determine whether regional brain activity is associated with specific cognitive problems. The researchers will obtain PET and neurocognitive data in 3 cohorts: subjects with a history of TBIs, subjects with mild cognitive impairment (MCI) and no TBI history, and healthy controls.~The investigators aim to determine whether individuals with TBI are on the same trajectory of neurodegenerative disease seen in AD or in CTE. Because of the overlap in clinical/cognitive and some behavioral symptoms in AD and CTE, an additional biomarker tool is needed to prevent misdiagnosis. Accurate diagnosis is crucial in order to provide patients with appropriate treatment.", - "NCTID": "NCT02266563" - }, - { - "brief_title": "Continuous Video- EEG Monitoring in the Acute Phase in Patients With a Cerebrovascular Attack- Randomisation of a Subpopulation Regarding Treatment Strategy", - "phase": "", - "drugs": "['starting of anti-epileptic drug treatment']", - "drugs_list": [ - "starting of anti-epileptic drug treatment" - ], - "diseases": "['Stroke']", - "diseases_list": [ - "Stroke" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with ischemic arteria cerebri media infarct and spontaneous intraparenchymal bleeding \n\n ", - "exclusion_criteria": ": \n\n Patients with subarachnoidal haemorrhage, traumatic haemorrhage (epidural/subdural bleeding), cerebral venous sinus thrombosis, epilepsy, anti-epileptic treatment, transient ischemic attack, indication for urgent neurosurgical intervention", - "brief_summary": "Stroke is a major cause of epilepsy. The pathophysiological mechanisms of poststroke epilepsy are not known. Subclinical epileptiform discharges could contribute to the neuronal damage and influence functional outcome. Electro-encefalography (EEG) is the golden standard to detect interictal, ictal and subclinical epileptic brain activity.~Patients admitted to the stroke unit with an ischemic or hemorrhagic cerebrovascular attack will undergo a 24 hours video-EEG monitoring to detect epileptiform discharges. Clinical and paraclinical (imaging, serum markers of neuronal damage) parameters will be analysed together with the EEG results. The EEG results will be correlated with the occurence of epileptic seizures and functional outcome and mortality in the acute phase and in the long-term. When subclinical epileptic discharges are found on the EEG, patients will be asked to participate in a second part of the study where they will be randomised into a treatment (with an anti-epileptic drug) versus no-treatment group for a period of 6 months. Outcome parameters will be the occurrence of epileptic seizures, mortality and functional outcome.~Our main hypothesis is that the occurrence of subclinical epileptiform discharges during the acute phase following stroke influences functional outcome.", - "NCTID": "NCT01862952" - }, - { - "brief_title": "Hair Cortisol Level as a Predictor of PTSD Development", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Post Traumatic Stress Disorder']", - "diseases_list": [ - "Post Traumatic Stress Disorder" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18-50 \n\n Experienced a traumatic event fitting criterion A1 (stressor), A2 (Reaction) and at least 1 out of the B criterion in the ASD criteria in the DSM-IV-TR \n\n Brought to the ER within hours of the traumatic event. \n\n Signed an informed consent \n\n ", - "exclusion_criteria": ": \n\n Known psychiatric disorder or current psychiatric medication \n\n Complex injury or need for a complex medical treatment, such as operation, Packed RBC or admission extending 36 hours. \n\n Disorientation, confusion, head injury including intra-cranial bleeding, LOC or a major neurological deficit. \n\n Known disorder of the HPA axis or use of steroidal medications within the previous 3 years. \n\n known neurological disease or previous brain surgery. \n\n Major medical conditions or using medication known to influence the HPA or ANS Axis. \n\n Baldness or hair shorter than 1cm. \n\n Using color dyes. \n\n Pregnancy.", - "brief_summary": "Post-traumatic stress disorder, PTSD, is one of the most prevalent psychiatric disorders.~As casualties of motor vehicle accidents, criminal acts or terrorism are arriving to the ER, it is almost impossible to conclude who will overcome his psychiatric trauma and will be able to return to his normal life course and who will be thrown out of his promising life trajectory.~Current attempts to identify those who are at the greatest risk are still unsatisfactory, which comprise a therapeutic dilemma, since the interventions used to ameliorate and prevent the occurrence of PTSD in a high-risk patient, might be counter-productive and even precipitate the emergence of PTSD in lower-risk patients.~Since PTSD is closely related to the Fight, Flight or Freeze reaction, it has much to do with the autonomic nervous system and the major stress hormone, cortisol. Despite many studies demonstrating the involvement of those factors in the development of PTSD, various attempts to profile the direction of the association between PTSD and cortisol abnormalities have yielded conflicting results.~The introduction of a novel method of assessing the excretion of cortisol using residues in the human hair shaft, has allowed an unprecedented evaluation of its activity over a prolonged period of time.~Using this novel method of cortisol assessment, the investigators aim to identify biomarkers that will be able to aid in the prediction of PTSD development ahead of symptoms emergence, and will enhance the understanding of the physiological mechanism involved and etiology of this disorder.", - "NCTID": "NCT01804426" - }, - { - "brief_title": "Cognitive Impairment and Balance in Elderly", - "phase": "", - "drugs": "['Descriptive study']", - "drugs_list": [ - "Descriptive study" - ], - "diseases": "['Mild Cognitive Impairment']", - "diseases_list": [ - "Mild Cognitive Impairment" - ], - "enrollment": "82.0", - "inclusion_criteria": "inclusion criteria: \n\n Nursing home residents. \n\n ", - "exclusion_criteria": ": \n\n Surgery on lower limbs. \n\n Traumatic damage on lower limbs. \n\n Severe cognitive impairment in order not to complete the assessment.", - "brief_summary": "One important issue in older adults with cognitive problems is the higher risk of fall due to decreased motor function and balance. The objective of this study is to evaluate the repercussions of mild cognitive impairment in balance in elderly.", - "NCTID": "NCT02051270" - }, - { - "brief_title": "Impact of Impaired Cerebral Autoregulation on Postoperative Delirium in Elderly Patients Undergoing Spine Surgery", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Delirium']", - "diseases_list": [ - "Delirium" - ], - "enrollment": "99.0", - "inclusion_criteria": "inclusion criteria: \n\n \u2265 70 years old, \n\n Undergoing any lumbar spine surgery, posterior cervical spine surgery, or anterior cervical spine surgery > 2 levels \n\n ", - "exclusion_criteria": ": \n\n MMSE < 15 \n\n Delirium at baseline \n\n Inability to speak and understand English \n\n Severe hearing impairment, resulting in inability to converse. \n\n Planned use of intraoperative ketamine \n\n Planned use of intraoperative remifentanil, except for airway management pre-incision. \n\n Arterial catheter not planned to be inserted", - "brief_summary": "Delirium (confusion) after surgery is common and associated with a longer hospitl stay and increased hopsital cost. There is very little information available about how often delirium occurs and the complications associated with it. Elderly patients are at high risk for delirium after surgery. This research is being done to measure how often delirium after spine surgery occurs and to see if there are ways to predict if delirium will develop. The results from this study will provide important information on a possible mechanism and predictor of delirium.", - "NCTID": "NCT01574950" - }, - { - "brief_title": "International Normalized Ratio (INR) Normalization in Coumadin Associated Intracerebral Haemorrhage", - "phase": "Phase 4", - "drugs": "['Prothrombin complex concentrate (PCC); fresh frozen plasma (FFP)']", - "drugs_list": [ - "Prothrombin complex concentrate (PCC); fresh frozen plasma (FFP)" - ], - "diseases": "['Intracranial Hemorrhages']", - "diseases_list": [ - "Intracranial Hemorrhages" - ], - "enrollment": "54.0", - "inclusion_criteria": "inclusion criteria: \n\n Spontaneous ICH (intraparenchymal), subdural hematoma (SDH) diagnosed by CT scanning \u2264 12 hours after onset of symptoms. In case of unknown time of symptom onset: time between last seen in healthy condition and first CCT \u2264 12 hours. \n\n Therapy receiving vitamin K antagonists (VKA) \n\n International Normalized Ratio (INR) \u2265 2 \n\n Signed informed consent form, or signed informed consent by a legal representative, judicial consent in cases where no legal representative is available in time, or consent of an independent physician familiar with the indication in cases where the first three possibilities can not be realized. \n\n ", - "exclusion_criteria": ": \n\n Patients with ICH not related to vitamin-K antagonist therapy or \n\n Patients with secondary ICH related to infarction, hemophilia or other coagulopathy, tumor, hemorrhagic infarction, cerebrovenous thrombosis, aneurysm, arteriovenous malformations (AVM) or severe trauma \n\n Deep Coma (GCS \u2264 5) at the time of admission or before intubation if intubated outside the hospital \n\n Known previous disability (mRS > 2 before stroke occurred) \n\n Acute myocardial ischemia, acute septicemia, acute crush injury, any history of acute hemorrhagic disseminated intravascular coagulation, acute thrombotic stroke \n\n Known history of intermittent claudication \n\n Known recent thrombotic event < 30 days \n\n Acute or known congestive heart failure (NYHA III, IV) \n\n Pulmonary edema \n\n Known liver failure (child-pugh-score C) \n\n Known alcohol or other drug abuse \n\n Known active malignant disease \n\n Known thrombocytopenia (platelets <50,000/\u00b5L), hemorrhagic diathesis (primary defects of coagulation, fibrinolysis, platelets) \n\n History of hypersensitivity to the investigational products or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational product \n\n Known allergy to heparin or history of heparin induced thrombocytopenia. \n\n Pregnancy and lactation \n\n Concomitant use of antithrombotic (with PTT > 1.5 of normal PTT), thrombolytic treatment. \n\n Use of aspirin, clopidogrel or dipyridamole or combinations thereof (e.g. Aggrenox\u00ae) is not an exclusion criterion. These drugs should be discontinued and not restarted earlier than 24 hours after normalization of INR if indicated. \n\n Previous participation in this trial", - "brief_summary": "Intracerebral haemorrhage (ICH) is the most feared complication in patients on vitamin K antagonists (VKA). VKA related ICH occurs 8-10 times more frequently and the mortality is 2 times higher than in non-anticoagulated patients. Mortality may rise up to 67%. The higher mortality rate may in part be due to the higher rate of haematoma expansion (HE) over a longer period after symptom onset. International guidelines recommend treatment of VKA-ICH with prothrombin complex (PCC) or fresh-frozen plasma (FFP) both in combination with Vitamin-K. But these recommendations are not based on randomized controlled trials. It is known that these drugs lower the INR, and thus it is assumed that normalization of coagulopathy may lead to haemostasis and reduction of HE. Safety and efficacy of these treatments have never been studied in a prospective controlled trial.~The investigators' questions are: How potent are PCC and FFP in normalization of the INR? What is the safety profile of each of these drugs?", - "NCTID": "NCT00928915" - }, - { - "brief_title": "Does Discontinuation of Aspirin Treatment Following Head Trauma Decrease the Incidence of Chronic Subdural Hematoma?", - "phase": "Phase 4", - "drugs": "['discontinuation of aspirin therapy', 'continuation of aspirin therapy']", - "drugs_list": [ - "discontinuation of aspirin therapy", - "continuation of aspirin therapy" - ], - "diseases": "['Head Trauma', 'Traumatic Brain Injury', 'Chronic Subdural Hematoma']", - "diseases_list": [ - "Head Trauma", - "Traumatic Brain Injury", - "Chronic Subdural Hematoma" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Completion of informed consent by the patient or a legally appointed guardian \n\n Age \u2265 50 years \n\n Sustained mild head trauma with visit to the emergency department of the Hadassah-Hebrew University Medical Center within 24 hours after trauma \n\n Low-dose aspirin therapy (75-100 mg) at time of head trauma \n\n Admission non contrast head CT with no evidence of intracranial hemorrhage or skull fracture, as assessed by the neurosurgical resident on call and confirmed by an attending neuroradiologist \n\n ", - "exclusion_criteria": ": \n\n Documented or suspected myocardial infarction within the last 12 mo \n\n Documented or suspected transient ischemic event or cerebrovascular accident within the last 12 months \n\n Coronary intervention within the last 6 mo \n\n Vascular stenting or bypass within the last 6 mo \n\n End-stage renal failure requiring dialysis \n\n Treatment with aspirin dose other than 75-100 mg \n\n Concomitant treatment by anti-coagulant or other anti-aggregant (e.g. warfarin, low molecular weight heparin, or clopidogrel)", - "brief_summary": "Anti-aggregation therapy, including treatment with low-dose aspirin (LDA) is an established risk factor for intracranial hemorrhage, including chronic subdural hematoma (CSDH); however evidence guiding the decision to continue or discontinue LDA in patients who have sustained mild head trauma with no sign of injury on CT is lacking. The investigators aim to assess whether continued aspirin treatment increases the risk of CSDH in mild head trauma patients 50 years and older who present with negative head CT. The investigators further aim to use the initial findings to refine the study design, with the goal of performing a larger, multi-institutional study in the future.~Over a 12-month period, approximately 100 patients \u226550 years of age on LDA prophylaxis presenting to Hadassah's Emergency Department after sustaining mild head injury, will be examined by the neurosurgeon on call. Those who have no sign of intracranial hemorrhage at clinical or CT examination, and who meet inclusion / exclusion criteria, will be invited to participate in a randomized study. Informed consent will be obtained. Patients will be remotely randomized for continuation or cessation of LDA treatment. Follow-up CT and clinical examination will be performed 3-5 weeks after trauma.~The two-proportions test will be used to assess whether there is a statistically significant difference in the rate of CSDH in patients randomized to cessation of LDA therapy and those randomized to continuation of LDA. Relationships between the explanatory the dependent variables will be explored with classical parametric and nonparametric statistical methods, including multivariate analysis, logistic regression, the two proportions test, and the independence test. Several measures of association/correlation between pairs of variables will be analyzed as well.~The investigators hypothesize that continuation of LDA will not be associated with increased risk for chronic subdural hematoma, and that cessation of treatment will not be associated with a decrease in chronic subdural hematoma. The investigators further hypothesize that cessation of LDA for this period will not be associated with increased risk for clinically significant cerebrovascular, cardiovascular, thrombotic, of embolic event.", - "NCTID": "NCT01470040" - }, - { - "brief_title": "Clinical Relevance of Microbleeds In Stroke", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Stroke', 'Atrial Fibrillation (AF)', 'Intracerebral Haemorrhage (ICH)']", - "diseases_list": [ - "Stroke", - "Atrial Fibrillation (AF)", - "Intracerebral Haemorrhage (ICH)" - ], - "enrollment": "2490.0", - "inclusion_criteria": "Study I: CROMIS-2 (AF) \n\n inclusion criteria: \n\n Adult (\u226518y; no upper limit) patients with a clinical diagnosis of non-valvular AF (verified by ECG) with intention to treat with best practice oral anticoagulants (e.g. warfarin) \n\n Previous ischaemic stroke or TIA diagnosed by treating clinician \n\n All patients must be able to have GRE MRI before (or within 1 week) of starting best practice oral anticoagulant \n\n ", - "exclusion_criteria": ": \n\n Any MRI contraindications \n\n Previous use of oral anticoagulation \n\n Definite contra-indication to oral anticoagulation \n\n Serious head injury (resulting to loss of consciousness) \n\n Study II: CROMIS-2 (ICH) \n\n inclusion criteria: \n\n \u2022 Adult (>18y) patients treated at participating centres with confirmed ICH (confirmed on CT or MRI scans) with or without a history of anticoagulant use at the time of the ICH \n\n ", - "brief_summary": "Study I: CROMIS-2 (AF) Prospective cohort study of patients anticoagulated after cardioembolic stroke An observational inception cohort study (n=1425) of patients throughout the United Kingdom (UK) - (79 hospitals) started on best practice oral anticoagulant (without prior use) for presumed cardioembolic ischaemic stroke due to non-valvular AF with follow up for the occurrence of intracerebral haemorrhage (ICH) and ischaemic stroke for an average of two years. The main baseline exposures (risk factors of interest) are the presence of cerebral microbleeds (CMBs) on magnetic resonance imaging (MRI), and genetic polymorphisms in candidate genes with potential functional relevance to ICH risk.~Study II: CROMIS-2 (ICH) Observational and genetics study of intracerebral haemorrhage The investigators will also recruit 600 patients admitted to participating centres with ICH (with a target of at least 300 anticoagulant-related ICH cases) and collect DNA to increase the power of the genetic studies. The investigators will collect clinical and imaging data from these ICH cases to investigate risk factors associated with anticoagulant-related ICH compared to non anticoagulant-related ICH.", - "NCTID": "NCT02513316" - }, - { - "brief_title": "Non-invasive Measuring of Cerebral Perfusion After Severe Brain Injury With Near-infrared-spectroscopy and ICG", - "phase": "", - "drugs": "['measuring cerebral perfusion by NIRS with ICG']", - "drugs_list": [ - "measuring cerebral perfusion by NIRS with ICG" - ], - "diseases": "['Subarachnoid Hemorrhage, Aneurysmal', 'Intracerebral Hemorrhage (ICH)', 'Traumatic Brain Injury']", - "diseases_list": [ - "Subarachnoid Hemorrhage", - "Aneurysmal", - "Intracerebral Hemorrhage (ICH)", - "Traumatic Brain Injury" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients over 18 years \n\n onset of clinical symptoms of subarachnoid or intracranial haemorrhage or trauma suffered less than 72h \n\n indication for implanting a tissue oxygen and intracranial pressure probe \n\n A signed informed consent by the patient or legal guardian \n\n ", - "exclusion_criteria": ": \n\n Persistent epidural, subdural or subcutaneous hematoma in planned area of the NIRS optode \n\n Open injuries in the area of the planned optodes \n\n Malignant primary disease under chemotherapy \n\n pregnancy \n\n bleeding disorder \n\n In the short term unfavorable prognosis (eg, bilateral wide and light-fixed pupils) \n\n Patients with pacemakers or where no MRI compatibility is due to non- removable metal parts \n\n contraindications for contrast media in CT (eg, iodine allergy) \n\n Untreated hyperthyroidism \n\n End Stage Renal Disease \n\n severe psychomotor agitation", - "brief_summary": "The purpose of this study is to show if it is possible to detect secondary ischemic events in patients with severe brain injury or cerebral haemorrhage with the help of non-invasive near-infrared spectroscopy (NIRS) by using the indocyanine green measuring of cerebral perfusion.", - "NCTID": "NCT01836848" - }, - { - "brief_title": "Memory Aid - Working Memory Training in Patients With Mild Cognitive Impairment.", - "phase": "", - "drugs": "['Computerized Working Memory Training.']", - "drugs_list": [ - "Computerized Working Memory Training." - ], - "diseases": "['Mild Cognitive Impairment']", - "diseases_list": [ - "Mild Cognitive Impairment" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who meet the Peterson diagnostic criteria of MCI: \n\n memory complaints (preferably confirmed by an informant). \n\n memory impairment according to age and education. \n\n preserved general cognitive function. \n\n intact activities of daily living, absence of dementia. \n\n ", - "exclusion_criteria": ": \n\n head trauma with post-traumatic loss of conscience for 30 minutes during lifespan. \n\n loss of senses (blindness, deafness). \n\n photo-sensitive epilepsy. \n\n unsuitability for Magnetic Resonance Imaging-examination due to metal foreign bodies or severe claustrophobia. \n\n drug and/or alcohol abuse.", - "brief_summary": "Background:~Mild Cognitive Impairment (MCI) is a condition characterized by memory problems more severe than normal cognitive changes due to old age, and less severe than dementia. Reduced working memory (WM) is regarded as one of the core symptoms of an MCI-condition. Recent studies have indicated that WM can be improved trough computer based training.~Objectives:~The objective of the study is to evaluate if working memory training is effective in improving working memory in elderly MCI-patients. Further, to evaluate if cognitive training relates to structural changes in the white and gray matter of the brain, assessed by structural Magnetic Resonance Imaging. Cognitive phenotypes related to memory impairment and progression to dementia will also be investigated.~Patients and Methods:~The proposed study is a blinded, randomized and controlled trail that will include 90 elderly patients from a Memory Clinic diagnosed with MCI. The groups will be randomized to either training or a placebo version. The intervention is computerized working memory training performed for 45 minutes over 25 sessions. Neuropsychological assessment and structural MRI will be performed before, 6 and 12 months after training.~Relevance:~Currently there is no known treatment available for mild memory impairment/MCI, and few studies on specific cognitive training in MCI-patients have been performed. The proposed study has received funding from a Norwegian Health Region. If computer based training results in positive changes to memory functions in MCI patients this may represent a new, cost-effective treatment. Secondly, evaluation of training induced structural changes to grey or white matter may improve our understanding of the mechanisms behind effective cognitive interventions in MCI patients.", - "NCTID": "NCT01991405" - }, - { - "brief_title": "The Effect of Anticholinergics on Cognitive Function in the Elderly", - "phase": "Phase 4", - "drugs": "['Trospium Chloride', 'Placebo']", - "drugs_list": [ - "Trospium Chloride", - "Placebo" - ], - "diseases": "['Mental Competency', 'Urinary Bladder, Overactive', 'Cognitive Function']", - "diseases_list": [ - "Mental Competency", - "Urinary Bladder", - "Overactive", - "Cognitive Function" - ], - "enrollment": "59.0", - "inclusion_criteria": "inclusion criteria: \n\n Female 50 or older \n\n Diagnosis of OAB (ICS definition) \n\n English literacy \n\n Ability to swallow oral medication \n\n Cognitive ability to give consent \n\n ", - "exclusion_criteria": ": \n\n Dementia/Depression/Delirium \n\n Current anticholinergic use (requires 2 week washout period) \n\n Current cholinesterase \n\n Urinary or gastric retention \n\n Severe decreased gastrointestinal motility \n\n Uncontrolled narrow-angle glaucoma \n\n Myasthenia gravis \n\n Diagnosis fo renal impairment (creatinine clearance <30 mL/min)", - "brief_summary": "Anticholinergic medication is used to treat overactive bladder (OAB). A known side effect of this medication is cognitive dysfunction. OAB is more prevalent in the elderly population - a group that also has a higher baseline risk of cognitive dysfunction. Our objective is to evaluate the effect of an anticholinergic medication on cognitive function in elderly women.", - "NCTID": "NCT01922115" - }, - { - "brief_title": "Neural Correlates of Cognitive Rehabilitation in Post-Traumatic Stress Disorder (PTSD)", - "phase": "", - "drugs": "['cognitive training', 'video game']", - "drugs_list": [ - "cognitive training", - "video game" - ], - "diseases": "['Post-Traumatic Stress Disorder']", - "diseases_list": [ - "Post-Traumatic Stress Disorder" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n OEF/OIF Veteran, \n\n meets DSM-IV criteria for PTSD, \n\n control group does not meet criteria for PTSD \n\n ", - "exclusion_criteria": ": \n\n prior history of significant head injury (LOC > 30 minutes) or other neurological disorder (e.g., stroke, seizure, multiple sclerosis), learning disability or confirmed diagnosis of ADHD, \n\n contraindication to MR imaging, failed malingering tests during testing, or a history of severe mental illness (i.e., Schizophrenia, Bipolar Disorder) \n\n individuals will be excluded if in the 30 days prior to the initial interview if they: \n\n do not have stable housing (i.e., staying in same residence), \n\n have medication changes or have had a psychiatric hospitalization, \n\n participants who meet DSM-IV criteria for substance dependence will be excluded from the study, \n\n individuals will also receive urine toxicology and Breathalyzer testing as the first procedure on the evaluation day (pre and post treatment and at 3 month follow up); participants who test positive for alcohol or recent substance use (e.g., methamphetamine) or report significant levels of drug or alcohol use if they are unable to abstain from substance use at three consecutive visits \n\n veterans who are currently engaged in therapy treatment for PTSD", - "brief_summary": "Post Traumatic Stress Disorder (PTSD) is an emotional disorder that can also lead to problems with attention and memory. Cognitive training has been successfully used to improve attention and processing speed in other patient populations as well as healthy elderly. The purpose of this study is to examine how effective cognitive training will be in Veterans with PTSD.", - "NCTID": "NCT00928941" - }, - { - "brief_title": "Functional Rehabilitation of Upper Limb Apraxia in Patients Poststroke", - "phase": "", - "drugs": "['Functional Rehabilitation of apraxia', 'Traditional health educative protocol']", - "drugs_list": [ - "Functional Rehabilitation of apraxia", - "Traditional health educative protocol" - ], - "diseases": "['Stroke', 'Apraxias']", - "diseases_list": [ - "Stroke", - "Apraxias" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Mild-moderate stroke after two month of the cerebrovascular attack. \n\n Upper limb apraxia lasting at least 2 months. \n\n Less than 9 points in validated Apraxia Screen of TULIA (AST) following Vanbellingen et al., 2010. \n\n Voluntary participation. \n\n The neurologist, the occupational therapist and the patient judge the intervention to be necessary. \n\n ", - "exclusion_criteria": ": \n\n History of apraxia before current stroke. \n\n Stroke had occurred less than two months or more than twenty four month ago. \n\n Cognitive impairment (< 23 in normal school population and < 20 points with a low education or illiteracy, in Spanish validation of Mini-Mental State Examination (MMSE)). \n\n Severe aphasia. \n\n Previous brain tumour. \n\n History of other previous neurologic disorders. \n\n Mother tongue different to Spanish. \n\n Drugs addiction. \n\n Intellectual or learning disorders. \n\n Brain damage for traumatism or neurodegenerative process. \n\n A history of serious consciousness impairments \n\n Uncooperativeness, presence of orthopedic or other disabling disorders.", - "brief_summary": "The purpose of this study is to analyze the effects of a mixed intervention of occupational therapy (rehabilitative and compensatory approach) at home to upper limb apraxia in mild and moderate patients post stroke in comparison to a control group with a traditional health educative protocol.", - "NCTID": "NCT02199093" - }, - { - "brief_title": "Delirium in Elderly Undergoing Cardiac Surgery and the Significance of CholinEsterase Activity", - "phase": "", - "drugs": "['Elective cardiac surgery']", - "drugs_list": [ - "Elective cardiac surgery" - ], - "diseases": "['Postoperative Complications']", - "diseases_list": [ - "Postoperative Complications" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Written informed consent \n\n \u2265 65 years of age \n\n Scheduled to undergo elective cardiac surgery (coronary artery bypass graft (CABG), valve surgery, combined CABG-valve surgery) with the use of CPB \n\n Both genders \n\n ", - "exclusion_criteria": ": \n\n Planned deep hypothermic arrest \n\n Acute / emergency procedures \n\n Surgery without extracorporeal circulation (ECC) \n\n Patients with a history of pseudocholinesterase deficiency \n\n Employees of the respective study centres \n\n Illiteracy \n\n Severe communication difficulties and severe vision or hearing problems \n\n Patients legally unable to give written informed consent \n\n non-fluency in German language \n\n Severe psychiatric or neuropsychiatric disorders \n\n MMSE < 24 points, short geriatric depression scale (GDS) \u2265 10 points \n\n Recent (<6 months) history of alcohol or drug abuse \n\n The participation in a drug or device trial within the previous 30 days", - "brief_summary": "The purpose of this study is to assess the association between the point-of-care (POC) measured ChE activity (Acetylcholinesterase (ChE) + Buturylcholinesterase (ChE)) and postoperative delirium in elderly patients undergoing cardiac surgery.~Furthermore the investigators aim to identify factors, which influence the baseline levels and the time course of ChE activity.", - "NCTID": "NCT02631304" - }, - { - "brief_title": "Dexmedetomidine and Delirium in Patients After Cardiac Surgery", - "phase": "Phase 4", - "drugs": "['dexmedetomidine hydrochloride for injection', '0.9% sodium chloride for injection']", - "drugs_list": [ - "dexmedetomidine hydrochloride for injection", - "0.9% sodium chloride for injection" - ], - "diseases": "['Delirium', 'C.Surgical Procedure; Cardiac', 'Postoperative Complications']", - "diseases_list": [ - "Delirium", - "C.Surgical Procedure; Cardiac", - "Postoperative Complications" - ], - "enrollment": "285.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients of 60 years or older who are planning to receive cardiac surgery (CABG and/or valve replacement surgery) \n\n ", - "exclusion_criteria": ": \n\n Patients will be excluded if they meet any of the following criteria: \n\n Refuse to participate; \n\n Preoperative history of schizophrenia, epilepsia, Parkinson syndrome, or severe dementia; \n\n Inability to communicate in the preoperative period because of severe visual/auditory dysfunction or language barrier; \n\n History of brain injury or neurosurgery; \n\n Preoperative sick sinus syndrome, severe bradycardia (HR < 50 bpm), second-degree or above atrioventricular block without pacemaker; \n\n Severe hepatic dysfunction (Child-Pugh class C); \n\n Severe renal dysfunction (requirement of renal replacement therapy); \n\n Other conditions that are considered unsuitable for participation.", - "brief_summary": "Postoperative delirium (POD) is a frequently occurring complication after cardiac surgery. Its occurrence is associated with worse outcomes of patients, including increased morbidity, prolonged hospital stay, increased medical cost, and higher mortality. It is also associated with long-term cognitive decline and decreased quality of life. However, until recently, pharmacological interventions that can effectively prevent its occurrence are still limited. The purpose of this study is to investigate whether perioperative dexmedetomidine use can decrease the incidence of postoperative delirium in patients undergoing cardiac surgery.", - "NCTID": "NCT02267538" - }, - { - "brief_title": "Lifespan Integration for Posttraumatic Stress Disorder From an Auto Accident", - "phase": "", - "drugs": "['Lifespan Integration Therapy', 'Lifespan Integration- Control']", - "drugs_list": [ - "Lifespan Integration Therapy", - "Lifespan Integration- Control" - ], - "diseases": "['Posttraumatic Stress Disorder']", - "diseases_list": [ - "Posttraumatic Stress Disorder" - ], - "enrollment": "6.0", - "inclusion_criteria": "inclusion criteria: \n\n Involved in or witnessed a car accident at least 6 months ago. \n\n PTSD or distress or impairment in important areas of functioning following the car accident \n\n ", - "exclusion_criteria": ": \n\n moderate or severe head injury \n\n current mental health treatment for the MVA-related problem \n\n severe chronic pre-injury mental health problems", - "brief_summary": "The purpose of this study is to evaluate if lifespan integration (LI) therapy reduces posttraumatic stress symptoms following a motor vehicle accident (MVA) trauma", - "NCTID": "NCT01263067" - }, - { - "brief_title": "Modafinil Versus Placebo for Hypoactive Delirium in the Critically Ill", - "phase": "Phase 3", - "drugs": "['Modafinil', 'Placebo']", - "drugs_list": [ - "Modafinil", - "Placebo" - ], - "diseases": "['Delirium', 'Respiratory Failure']", - "diseases_list": [ - "Delirium", - "Respiratory Failure" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria \n\n Adult patients \u2265 18 yrs of age, < 76 yrs of age \n\n Admitted to MICU (3B and 3C) or SICU (8C, 8D, 11C) \n\n Surrogate present to provide informed consent when patient is not able \n\n RASS score of >-3, < +1 \n\n CAM positive \n\n Enteral access \n\n ", - "exclusion_criteria": ": \n\n Recent MI (within past 2 weeks) \n\n High risk of dysrhythmias (i.e. bundle branch block, QT prolongation, class IV HF, implanted device) \n\n Unable to tolerate enteric medication \n\n History of stimulant induced mania/psychosis \n\n Pre-existing neurologic disease \n\n Patients transferred from outside hospital \n\n Pregnancy \n\n Alcohol withdrawal \n\n History of end stage liver disease (Childs-Pugh class B or worse) \n\n Prognosis considered hopeless (CMO)", - "brief_summary": "This is a randomized, double-blind, placebo controlled study of 30 patients. Patients who qualify, as per the inclusion criteria (RASS greater than -3, less then +1, CAM positive, present gastric access) will either be given 200mg of modafinil or an identical, indistinguishable placebo. The placebo and study drug will be distributed by the hospital pharmacy. Once enrolled, each patient will be reassessed every morning to determine appropriateness for drug administration. If the RASS is less than -3 (i.e. comatose) or greater then 0 modafinil will not be given. He/she will then be assessed each morning thereafter. Due to the stimulant-like actions of modafinil, the drug will be administered only in the morning. Patients will be assessed for delirium at least twice a day; trained personnel using the Confusion Assessment Method (CAM) will do the assessment. Qualification for a delirium free day will be no positive CAM screens for 24 hours following drug administration. Additional data such as days on mechanical ventilation and progression to tracheotomy will also be collected hypothesizing that patients who take modafinil will have a shorter time to extubation therefore avoiding the need for a tracheotomy. Post-discharge from the unit, but within 48 hours, patients will be asked to participate in a survey (The Richards-Campbell Sleep Questionnaire (RCSQ) assessing their perception of daytime and nighttime sleepiness in the intensive care unit as well as their overall perception of rest. Their functional capacity will also be evaluated at this time and compared to their pre-morbid baseline. The hypothesis tested is that Modafinil restores sleep cycle synchrony in the ICU therefore increasing delirium free days and improving ICU outcomes.", - "NCTID": "NCT02028260" - }, - { - "brief_title": "Pilot Study of a Multicomponent Nurse Intervention to Reduce Delirium in Hospitalized Older Adults", - "phase": "", - "drugs": "['Multicomponent nurse-led intervention']", - "drugs_list": [ - "Multicomponent nurse-led intervention" - ], - "diseases": "['Delirium']", - "diseases_list": [ - "Delirium" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with an age equal or older than 65 years \n\n Hospitalized at the Acute Geriatric Unit of the Complejo Hospitalario Universitario of Albacete \n\n Valid signed informed consent by the patient or legal representative. \n\n ", - "exclusion_criteria": ": \n\n Agonic situation \n\n Non-Spanish speaking \n\n Severe cognitive decline (Reisberg\u00b4s Global Deterioration Scale = 7) \n\n Patients sharing the same room with a previously included participant", - "brief_summary": "Objectives: To analyze if a multicomponent nurse-led intervention randomized clinical trial (MID-Nurse Study) is feasible (Pilot study), and can reduce the incidence, duration, and severity of delirium in hospitalized older adults in an AGU.~Design: Parallel-group Double-blind Randomized Clinical Trial (Pilot Study). Setting: AGU Complejo Hospitalario Universitario from Albacete (Albacete, Spain).~Participants: 50 patients \u2265 65 years hospitalized in the AGU (21 intervention group, 29 control group).~Interventions: After risk factor analysis, all participants in the intervention group (IG) received a daily multicomponent intervention (orientation, sensorial deficit, sleep, mobilization, hydration, nutrition, drugs, elimination, oxygenation, pain) by the intervention nurses. The control group (CG) received usual care.~Measurements: Delirium presence was determined daily with the Confusion Assessment Method (CAM), and delirium severity with the Delirium Rating Scale-Revised-98 (DRS). Mortality, days of hospitalization, use of physical restraint measures, and use of drugs for delirium control (neuroleptics and benzodiacepines) were also recorded.", - "NCTID": "NCT02558777" - }, - { - "brief_title": "Florbetapir Calibration to the Centiloid Scale", - "phase": "Phase 1", - "drugs": "['Florbetapir (18F)', '11C-PiB']", - "drugs_list": [ - "Florbetapir (18F)", - "11C-PiB" - ], - "diseases": "[\"Alzheimer's Disease\"]", - "diseases_list": [ - "Alzheimer's Disease" - ], - "enrollment": "35.0", - "inclusion_criteria": "inclusion criteria: \n\n Cognitively Normal Subjects \n\n Males or females \u2265 21 and \u2264 45 years of age \n\n Mini-mental state examination (MMSE) \u2265 29 \n\n Clinically Diagnosed AD Subject \n\n Males or females \u2265 50 years of age \n\n Meet clinical criteria for dementia due to probable AD \n\n MMSE \u2265 16 and \u2264 26 \n\n Possible AD Subject \n\n Males or females \u2265 50 years of age \n\n Meet clinical criteria for dementia due to possible AD \n\n MMSE \u2265 16 and \u2264 26 \n\n MCI Subject \n\n Males or females \u2265 60 years of age with cognitive impairment (not dementia) \n\n MMSE >24 and <29 \n\n At Risk Elderly Subject \n\n Cognitively normal males or females that are known ApoE4 carriers and \u2265 75 years of age \n\n MMSE \u2265 27 \n\n ", - "exclusion_criteria": ": \n\n Have had or currently have a diagnosis of neurodegenerative disorders other than AD \n\n Have a current serious or unstable illness that could interfere with completion of the study \n\n Subject has a known brain lesion, pathology or traumatic brain injury \n\n Have received or participated in a trial with investigational medications in the past 30 days \n\n Have had a radiopharmaceutical imaging or treatment procedure within 7 days of study imaging session \n\n Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception", - "brief_summary": "This study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.", - "NCTID": "NCT02120664" - }, - { - "brief_title": "Delirium at the Intensive Care Unit - a Retrospective Cohort Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Delirium', 'Intensive Care Unit Syndrome']", - "diseases_list": [ - "Delirium", - "Intensive Care Unit Syndrome" - ], - "enrollment": "183.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients >18 years of age admitted to the ICU at K\u00f8ge Hospital in the study period \n\n ", - "exclusion_criteria": ": \n\n Richmond Agitation Sedation Score (RASS): -4 or -5 during the whole study period \n\n No CAM-ICU scores during the ICU stay \n\n Unable to communicate in Danish (aphasic, deaf, non-Danish speaking, severe brain damage) \n\n Severe dementia documented in electronic patient charts (OPUS) \n\n Patients not receiving active treatment (moribund patients)", - "brief_summary": "This project seeks to describe the incidence of delirium in the Intensive Care Unit (ICU) and to identify risk and preventive factors associated with development of delirium.~Especially, the investigators want to investigate if an imitated natural light/dark cycle influences frequency of delirium.", - "NCTID": "NCT02603731" - }, - { - "brief_title": "Incidence, Long- Term Outcome and Factor Related to Non- Cardiac Postoperative Delirium in Elderly Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Postoperative Delirium']", - "diseases_list": [ - "Postoperative Delirium" - ], - "enrollment": "400.0", - "inclusion_criteria": "inclusion criteria: \n\n Age >/ 60 years \n\n American Society of Anesthesiologists (ASA) physical status 1-3 \n\n Undergoing scheduled surgery \n\n Giving an informed consent \n\n ", - "exclusion_criteria": ": \n\n Impaired visual and auditory disturbance \n\n Cannot communicate with Thai language \n\n Undergoing neurosurgery", - "brief_summary": "The purpose of this study is to determine the incidence, long term outcome and factor related to postoperative delirium in elderly patients after non-cardiac surgery.", - "NCTID": "NCT02131181" - }, - { - "brief_title": "Biomarkers and Early Alzheimer's Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "[\"Alzheimer's Disease\"]", - "diseases_list": [ - "Alzheimer's Disease" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n Individuals of either sex, with a high school education, and between the ages of 60 and 80 years living in the New York City metropolitan area. \n\n Minimum of 12 years education. \n\n Participants will be classified as within normal limits on medical, psychiatric and neuropsychological examinations (performance that is better than -1.5 sd of the NYU norm based WMS-R delayed memory index). \n\n Participants will have a global deterioration scale (GDS)=1 or 2. Those enrolled in the High-Risk group will have a GDS=2 and have a score of >25 on the Memory Complaint Questionnaire (MCQ). In high risk memory loss cases, an informed family member or caregiver will be interviewed to confirm that the participant can perform specific tasks. \n\n ", - "exclusion_criteria": ": \n\n Past history or MRI evidence of brain damage including significant trauma, stroke, hydrocephalus, lacunar infarcts, seizures, mental retardation or serious neurological disorder. \n\n Significant history of alcoholism or drug abuse. \n\n History of psychiatric illness (e.g., schizophrenia, mania, Post-Traumatic Stress Disorder [PTSD], or depression). \n\n Any focal neurological signs or significant neuropathology. \n\n A score of 4 or greater on the Modified Hachinski Ischemia Scale, indicative of cerebrovascular disease. \n\n A total score of 16 or more on the Hamilton Depression Scale to exclude possible cases of primary depression. \n\n Evidence of clinically relevant and uncontrolled hypertensive, cardiac, pulmonary, vascular, metabolic or hematologic conditions. \n\n Physical impairment of such severity as to adversely affect the validity of psychological testing. \n\n Hostility or refusal to cooperate. \n\n Any prosthetic devices (e.g., pacemaker or surgical clips) that could be affected by the magnetic field employed during MRI imaging. \n\n History of familial early onset dementia.", - "brief_summary": "The main goal of this project is to use imaging and biomarkers to identify cognitively normal elderly people who are at increased risk for developing mild cognitive impairment (MCI). MCI is the earliest clinically detectable evidence for brain changes due to Alzheimer's disease (AD). The second goal of this project is to describe the inter-relationships among anatomical biomarkers, cerebrospinal fluid biomarkers, and cognition measures in those elderly people who develop MCI.", - "NCTID": "NCT00094952" - }, - { - "brief_title": "Hip Fracture Surgery in Elderly Patients", - "phase": "Phase 2", - "drugs": "['Xenon', 'Sevoflurane']", - "drugs_list": [ - "Xenon", - "Sevoflurane" - ], - "diseases": "['Delirium']", - "diseases_list": [ - "Delirium" - ], - "enrollment": "256.0", - "inclusion_criteria": "inclusion criteria: \n\n Elderly patient (\u2265 75 years) \n\n Patient with planned hip fracture surgery within 48 hours after the hip fracture \n\n Patient willing and able to complete the requirements of this study including the signature of the written informed consent \n\n ", - "exclusion_criteria": ": \n\n Patient suffering from multiple fractures, pelvic fractures proximal, pathological fractures, femur fractures (i.e., fractures of the middle or distal femur) \n\n Disabling neuropsychiatric disorders (severe dementia, Alzheimer's disease, schizophrenia, depression) \n\n Brain trauma within 12 months prior to selection, history of stroke with residuals \n\n Patient suffering from delirium (CAM diagnosis) at selection \n\n Patient who cannot complete the pre-operative mental tests (CAM and/or MMSE) of this clinical trial \n\n Patient with Mini-Mental State Examination (MMSE) score < 24 at selection \n\n Patient known to susceptible to malignant hyperthermia \n\n Patient with elevated intra-cranial pressure \n\n Patient with a risk of high oxygen demand \n\n Patient with recent or ongoing myocardial infarction / damage \n\n Patient with severe cardiac failure, or patient with severe impaired left ventricular systolic function \n\n Patient with known severe lung and/or airway disease, or severe chronic respiratory insufficiency, or a sustained homecare oxygen therapy \n\n Contra-indication (serious illness or medical conditions) for general anaesthesia \n\n Known allergy or hypersensitivity to any drugs administered during this clinical trial \n\n Previous participation in this clinical trial \n\n Participation in another clinical trial within 4 weeks prior to selection \n\n History of alcohol or drug abuse or psychiatric disorders which would impair the understanding of the necessary information or render medically or legally unable to give written informed consent", - "brief_summary": "The objective of this study is to evaluate the incidence of Post-Operative Delirium (POD), diagnosed with the Confusion Assessment Method (CAM), in elderly patients undergoing hip fracture surgery under general anaesthesia with xenon or sevoflurane, for a period of four days post-surgery.", - "NCTID": "NCT01199276" - }, - { - "brief_title": "Factors Affecting the Incidence of Postoperative Delirium in Frail Elderly", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Postoperative Delirium']", - "diseases_list": [ - "Postoperative Delirium" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Elderly (> 65 years) frail patients undergoing non cardiac surgery under anaesthesia lasting for >60 minutes \n\n Patient willing and able to complete the requirements of this study. \n\n ", - "exclusion_criteria": ": \n\n disabling neuropsychiatric or neurological disorders(including severe dementia, Alzheimer's disease, schizophrenia, severe depression) \n\n patients suffering from delirium at selection; \n\n patients who cannot complete the preoperative mental tests (CAM and/or Mini-Mental State Examination (MMSE)) of this clinical trial;", - "brief_summary": "Postoperative delirium has been found to be associated with increased risk of future neurocognitive decline and mortality especially in elderly patients. Similarly, Frailty has been found to be associated with an increased risk of postoperative complication including delirium in the elderly.The purpose of this study is determine the factors affecting the incidence of postoperative delirium in frail elderly undergoing non-cardiac surgery in the Singapore population.", - "NCTID": "NCT02227225" - }, - { - "brief_title": "Postoperative Delirium in Hip Arthroplasty Patients", - "phase": "", - "drugs": "['miRNA Testing, Microemboli Monitoring, Delirium Assessment']", - "drugs_list": [ - "miRNA Testing", - "Microemboli Monitoring", - "Delirium Assessment" - ], - "diseases": "['Delirium', 'Postoperative Complications']", - "diseases_list": [ - "Delirium", - "Postoperative Complications" - ], - "enrollment": "49.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female, between 30 and 80 years of age \n\n ASA I , II or III \n\n Capable and willing to consent \n\n Participants literate in English language \n\n ", - "exclusion_criteria": ": \n\n ASA IV or V \n\n Patients with severe visual or auditory disorder \n\n Illiteracy \n\n Presence of a clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia \n\n Dementia of Alzheimer's type \n\n Parkinson disease \n\n Multiple Sclerosis (MS) \n\n Vascular dementia", - "brief_summary": "Identification of specific circulating microRNAs and microemboli formation (diagnosed by TC Doppler) in both delirious groups and nondelirious group will be our primary target. Delirium assessment through standardized questionnaires will be done at baseline (day of the surgery - pre operatory), immediately after surgery (in post anesthesia care unit) and then every 12 hours in Day 1 and Day2 after surgery. The investigators will use linear mixed models to describe the change patterns overtime, and compare differences at each time point. Inflammatory biomarkers will be explored overtime as well. The investigators will also explore age effect on cognitive function - cognitive reserve - based on the score of the cognitive test administered at baseline.", - "NCTID": "NCT02323984" - }, - { - "brief_title": "Kappa Opioid Receptor Imaging in Post-traumatic Stress Disorder (PTSD)", - "phase": "", - "drugs": "['Positron emission tomography (PET) imaging']", - "drugs_list": [ - "Positron emission tomography (PET) imaging" - ], - "diseases": "['Post-traumatic Stress Disorder (PTSD)', 'Trauma']", - "diseases_list": [ - "Post-traumatic Stress Disorder (PTSD)", - "Trauma" - ], - "enrollment": "17.0", - "inclusion_criteria": "inclusion criteria for patients with PTSD: \n\n age 18-55 years old \n\n currently diagnosed with PTSD and symptomatic with a Clinician-Administered PTSD Scale (CAPS) score > 50. \n\n ", - "exclusion_criteria": " for patients with PTSD: \n\n any primary Axis I disorder other than PTSD (e.g. psychosis) \n\n medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders \n\n a history of drug (including benzodiazepines (BZD)) dependence (Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria) within 1 year of the study and lasting longer than 2 years, except for alcohol dependence \n\n current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study) \n\n current breast feeding \n\n use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day, or cannot abstain from smoking during the prescribed tests \n\n acute suicidal ideation or behavior, as defined by suicidal ideation and behavior during the 3-month period prior to enrollment in the study and while being enrolled in the study \n\n general MRI ", - "brief_summary": "This study uses positron emission tomography (PET) imaging to measure kappa opioid receptors (KOR) in the brains of individuals with and without post-traumatic stress disorder (PTSD). The investigators propose to recruit 45 drug-na\u00efve individuals, N=15 patients with PTSD, N=15 trauma-exposed, but asymptomatic healthy control subjects (TC) and N=15 non-trauma exposed healthy control subjects (HC) to participate in one magnetic resonance imaging (MRI) and one PET study. The investigators will also carefully document trauma history, and collect behavioral and neuroendocrine measures to provide a more integrative view on the neurobiology of PTSD and its phenotype. The investigators predict PTSD will show greater carbon - 11 (11C)[11C]LY2795050 volume of distribution (VT) (i.e. KOR binding) values than control populations in an a priori defined PTSD circuit.", - "NCTID": "NCT02237703" - }, - { - "brief_title": "Comparison of Dexmedetomidine and Propofol on the Delirium and Neuroinflammation in Patients With SIRS.", - "phase": "Phase 4", - "drugs": "['Dexmedetomidine', 'Propofol']", - "drugs_list": [ - "Dexmedetomidine", - "Propofol" - ], - "diseases": "['Delirium']", - "diseases_list": [ - "Delirium" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n presence of delirium \n\n ", - "exclusion_criteria": ": \n\n presence of Alzheimer's disease \n\n any mental disorder \n\n presence of cancer", - "brief_summary": "Assessment of sedative effects of dexmedetomidine and propofol on the clinical course of delirium and neuroinflammation in patients with SIRS using CAM-ICU scale and protein S100b in serum.", - "NCTID": "NCT02366299" - }, - { - "brief_title": "Effect of Sevoflurane, Propofol and Dexmedetomidine on Delirium & Neuroinflammation in Mechanically Ventilated Patients", - "phase": "Phase 4", - "drugs": "['Sevoflurane', 'Propofol', 'Dexmedetomidine']", - "drugs_list": [ - "Sevoflurane", - "Propofol", - "Dexmedetomidine" - ], - "diseases": "['Delirium']", - "diseases_list": [ - "Delirium" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n presence of delirium \n\n ", - "exclusion_criteria": ": \n\n presence of Alzheimer's disease \n\n any mental disorder \n\n presence of cancer", - "brief_summary": "Assessment of sedative effects of sevoflurane, dexmedetomidine and propofol on the clinical course of delirium, SIRS and neuroinflammation in mechanically ventilated patients using CAM-ICU scale, GSK-3beta and protein S100b in serum.", - "NCTID": "NCT02394418" - }, - { - "brief_title": "Delirium Recall in Advanced Cancer Patients", - "phase": "", - "drugs": "['Questionnaire']", - "drugs_list": [ - "Questionnaire" - ], - "diseases": "['Advanced Cancer', 'Delirium']", - "diseases_list": [ - "Advanced Cancer", - "Delirium" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Presence of advanced cancer, defined as local recurrent and/or metastatic. \n\n History of an episode of delirium during the patient's current inpatient admission, diagnosis of delirium will be made by one of the palliative care specialists according to DSM-IV-TR criteria. \n\n If the patient has a complete recovery from the episode of delirium, the patient must be approached within 3 days for the possibility of inclusion in study. Complete recovery will be defined as diagnosis of complete resolution of all symptoms of delirium according to DSM-IV-TR criteria by one of the palliative care specialists. \n\n Ability to communicate in the English language. \n\n Caregiver who is 18 years of age or older (assessments used in this study have not been validated in pediatric population), is able to communicate in English and comprehend the assessment questionnaire, and is at the bedside for a significant length of time (approximately 4 hours) each day during the delirium episode. Both the patient and their caregiver must agree to participate for inclusion in the study. \n\n Written informed consent signed by the patients and the participating caregivers. \n\n MDAS [Memorial Delirium Assessment Scale] < 13 (Scores of 13 or above likely reflect the presence of delirium). \n\n Patients will be recruited from the palliative care mobile team or the inpatient palliative care unit. \n\n ", - "exclusion_criteria": ": \n\n Refusal of both the patient and their caregiver to complete assessments \n\n Inability to complete assessment due to sensorial deficits other than cognition; e.g. blindness, deafness, aphasia, etc., that might impact the patient's ability to recall the episode of delirium.", - "brief_summary": "Primary Objectives:~To determine the proportion of patients who experience partial or complete recollection of symptoms of delirium and the level of distress associated with this recall.~To determine caregiver's level of distress associated with the patient's episode of delirium.", - "NCTID": "NCT00493714" - }, - { - "brief_title": "Trial to Reduce Falls Incidence Rate in Frail Elderly", - "phase": "", - "drugs": "['Fall prevention course']", - "drugs_list": [ - "Fall prevention course" - ], - "diseases": "['Accidental Falls']", - "diseases_list": [ - "Accidental Falls" - ], - "enrollment": "320.0", - "inclusion_criteria": "inclusion criteria: \n\n At least one fall in the last 6 months \n\n Living in their own home or in a home for the aged \n\n Availability of a primary caregiver caring for the patient at least once a week \n\n Ability to walk 15 meters independently (use of a walking aid is permitted) \n\n Life expectancy of more than 6 months, as judged by their geriatrician \n\n ", - "exclusion_criteria": ": \n\n Dyads of patients and caregivers in whom outcome assessment is highly unlikely to succeed, for example because they proved not to be able to register falls in the three months before randomization, will be excluded \n\n MMSE score of less than 15 \n\n On the waiting list for a nursing home", - "brief_summary": "Background: Approximately 750,000 elderly Dutch people fall at least once a year, which often results in physical injuries and a fear of falling, with high costs and far-reaching consequences on functionality, physical activity, quality of life and mental well-being. Falling is not only a burden for patients, it is also a burden for their caregivers. Recurrent falling is a complex problem. However, the pathophysiological background of falls, gait problems and dementia is largely unknown. The general pathophysiological hallmark of aging is a liability in homeostatic mechanisms of organs. This liability results in an impaired ability to adapt to stress and in increased biological variation in outcome measures within individuals. In this study the investigators aim at developing an intervention to reduce recurrent falling in frail elderly fallers.~Hypotheses: The investigators hypothesize that the intervention program will decrease the number of falls and fear of falling and increase mental well-being, physical activity and functional performance in frail elderly people with a history of recurrent falling. In addition, the burden on the caregivers will be reduced due to the intervention and will be cost-effective. Furthermore, the investigators hypothesize that patients with a high short-term intra-individual biological variability in gait and cognition variables have a higher risk of falling, worse gait performance and cognitive decline after long term follow-up.~Study Design: Randomized, controlled, single-blind trial.~Study Population: 160 patients referred to a geriatric outpatient clinic, who fell at least once in the last 6 months and their primary caregivers (N=160).~Intervention: A multifaceted fall prevention program for frail elders to reduce falls incidence rate, consisting of physical and cognitive components. Moreover, it includes a training program for caregivers in which they learn to support and give advice to the patients, aiming to decrease the burden on the caregivers.~Primary Outcome Measures: The fall incidence rate is the primary outcome measure. Total observation time of falls will be 6 months after the start of the intervention.~Secondary Outcome Measures: In the patients, the secondary outcome measures are fear of falling (FES), quality of life (MOS-20), depression and general anxiety, functional performance in activities of daily living, physical activity, mobility, gait parameters, body sway and biomarkers of endothelial function and frailty. For the caregiver, the secondary outcome measures are caregiver's burden, mood and quality of life. In addition, intraindividual variability of cognition, balance and gait in both patients and caregivers, will be assessed and cost-effectiveness of the intervention will also be determined.", - "NCTID": "NCT00512655" - }, - { - "brief_title": "Hematopoietic Stem Cell Dysfunction in the Elderly After Severe Injury", - "phase": "", - "drugs": "['Bone marrow collection', 'Blood collection', 'Clinical data collection']", - "drugs_list": [ - "Bone marrow collection", - "Blood collection", - "Clinical data collection" - ], - "diseases": "['Trauma Injury']", - "diseases_list": [ - "Trauma Injury" - ], - "enrollment": "400.0", - "inclusion_criteria": "Severe Trauma Population \n\n inclusion criteria will be: \n\n All adults (age \u226518 to 54) \n\n Blunt and/or penetrating trauma resulting in long bone or pelvic fractures requiring ORIF or closed reduction percutaneous pinning (CRPP). \n\n Blunt and/or penetrating trauma patient with either: \n\n hemorrhagic shock defined by: i. systolic BP (SBP) \u2264 90 mmHg or ii. mean arterial pressure\u2264 65 mmHg or iii. base deficit (BD) \u2265 5 meq or iv. lactate \u2265 2 \n\n Or injury severity score (ISS) greater than or equal to 15. \n\n All adults (age 55 and older) require: \n\n Blunt and/or penetrating trauma resulting in log bone or pelvic fractures requiring ORIF or CRPP \n\n Either hemorrhagic shock defined by: i. Systolic BP (SBP) \u2264 90 mmHg or ii. Mean arterial pressure \u2264 65 mmHg or iii. Base deficit (BD) \u22655 meq or iv. Lactate \u2265 2 \n\n Or Injury Severity Score (ISS) greater than or equal to 15. \n\n Ability to obtain Informed Consent prior to OR repair of injury. \n\n ", - "exclusion_criteria": " will be: \n\n Patients not expected to survive greater than 48 hours. \n\n Prisoners. \n\n Pregnancy. \n\n Patients receiving chronic corticosteroids or immunosuppression therapies. \n\n Previous bone marrow transplantation. \n\n Patients with End Stage Renal Disease. \n\n Patients with any pre-existing hematological disease. \n\n Elective Hip Repair Population \n\n inclusion criteria will be: \n\n All adults (age \u226518) \n\n Patient undergoing elective hip repair for non-infectious reasons. \n\n Ability to obtain Informed Consent prior to operation. \n\n ", - "brief_summary": "Traumatic injury is a leading cause of morbidity and mortality in young adults, and remains a substantial economic and health care burden. Despite decades of promising preclinical and clinical investigations in trauma, investigators understanding of these entities is still incomplete, and few therapies have shown success. During severe trauma, bone marrow granulocyte stores are rapidly released into the peripheral circulation. This release subsequently induces the expansion and repopulation of empty or evacuated space by hematopoietic stem cells (HSCs). Although the patient experiences an early loss of bone marrow myeloid-derived cells, stem cell expansion is largely skewed towards the repopulation of the myeloid lineage/compartment. The hypothesis is that this 'emergency myelopoiesis' is critical for the survival of the severely traumatized and further, failure of the emergency myelopoietic response is associated with global immunosuppression and susceptibility to secondary infection. Also, identifying the release of myeloid derived suppressor cells (MDSCs) in the circulation of human severe trauma subjects. This process is driven by HSCs in the bone marrow of trauma subjects. Additionally, MDSCs may have a profound effect on the nutritional status of the host. The appearance of these MDSCs after trauma is associated with a loss of muscle tissue in these subjects. This muscle loss and possible increased catabolism have huge effects on long term outcomes for these subjects. It is the investigator's goal to understand the differences that occur in these in HSCs and muscle cells as opposed to non-injured and non-infected controls. This work will lead to a better understanding of the myelopoietic and catabolic response following trauma.", - "NCTID": "NCT02577731" - }, - { - "brief_title": "Impact of Unenhanced Computed Tomography (CT) in Elderly Patients Admitted to the Emergency Department With Acute Abdominal Pain", - "phase": "", - "drugs": "['Unenhanced abdominal Computed Tomography']", - "drugs_list": [ - "Unenhanced abdominal Computed Tomography" - ], - "diseases": "['Abdominal Pain']", - "diseases_list": [ - "Abdominal Pain" - ], - "enrollment": "423.0", - "inclusion_criteria": "inclusion criteria: \n\n Elderly patients admitted to the emergency department (aged 75 year old and older) \n\n acute abdominal pain \n\n informed consent \n\n ", - "exclusion_criteria": ": \n\n traumatic pain \n\n symptom duration of more than a week \n\n unability for the patient to give informed consent", - "brief_summary": "The purpose of this study is to determine whether non-contrast abdominal computed tomography (CT) impacts management (diagnosis, need for surgery and treatment) in elderly patients admitted to the emergency department with abdominal pain.", - "NCTID": "NCT02355483" - }, - { - "brief_title": "Study on the Efficacy of Speed-Feedback Therapy for Elderly People With Dementia", - "phase": "Phase 4", - "drugs": "['Speed-feedback therapy system with a bicycle ergometer', 'Ergometer at conventional settings']", - "drugs_list": [ - "Speed-feedback therapy system with a bicycle ergometer", - "Ergometer at conventional settings" - ], - "diseases": "['Dementia']", - "diseases_list": [ - "Dementia" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n 65 years of age or older \n\n Diagnosed with dementia by a physician \n\n Mini-Mental State Examination score of 23 points or less \n\n Capable of participating at least once a week for 6 weeks in succession \n\n ", - "exclusion_criteria": ": \n\n Management of a medical risk required \n\n Impaired ability to pedal the ergometer because of an orthopedic or surgical disease of the lower extremities or central nerve paralysis \n\n Never having been on a bicycle, and incapable of pedaling well", - "brief_summary": "The purpose of this study is to verify the efficacy of speed-feedback therapy in improving the cognitive function of elderly people with dementia by a randomized controlled trial, and to demonstrate how that affects ADL and QOL.", - "NCTID": "NCT00450047" - }, - { - "brief_title": "A Study of Single and Multiple Ascending Doses of TC-5214 in Japanese Healthy Elderly Male and Female Volunteers", - "phase": "Phase 1", - "drugs": "['TC-5214', 'Placebo']", - "drugs_list": [ - "TC-5214", - "Placebo" - ], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "48.0", - "inclusion_criteria": "inclusion criteria: \n\n Japanese healthy elderly male and female \u226565 years old. \n\n Have a BMI of \u226518 and \u226427 kg/m2 and weigh \u2265 45 kg. \n\n Be able to understand and comply with the requirements of the study as judged by the investigator(s). \n\n ", - "exclusion_criteria": ": \n\n History of any clinically significant medical or neurologic disease or disorder. \n\n History of gastrointestinal surgery or unintentional rapid weight loss. \n\n Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the study drug.", - "brief_summary": "The purpose of this study is to assess safety, tolerability and pharmacokinetics of TC-5214 in elderly healthy Japanese volunteers.", - "NCTID": "NCT01392820" - }, - { - "brief_title": "Validation of a Delirium Monitor", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Delirium']", - "diseases_list": [ - "Delirium" - ], - "enrollment": "159.0", - "inclusion_criteria": "inclusion criteria: \n\n 60 years and older \n\n Frail \n\n Undergoing elective surgery \n\n Expected to remain admitted for at least 2 postoperative days \n\n ", - "exclusion_criteria": ": \n\n No communication possible due to a language barrier or deafness \n\n Admission for neurological surgery \n\n Participation in this study during a previous hospital admission \n\n Practical or logistical reasons hampering the use of the delirium monitor, such as technical failure of the monitor \n\n Isolation because of known carrier ship of a resistant bacterium", - "brief_summary": "Delirium is a common disorder in hospitalized patients, nevertheless it is poorly recognized by physicians and nurses, even when screening instruments are used. Electroencephalography (EEG) appears to be a sensitive tool for the diagnosis of delirium. However, standard EEG recording with 25 electrodes is labor intensive. We have previously showed that a brief EEG registration with three electrodes and automatic processing can distinguish patients with delirium from patients without delirium very well. However, these findings need to be validated in an unselected population.~The primary objective of this validation study is to investigate the sensitivity, specificity, and predictive values of the EEG-based delirium monitor (including three electrodes and a reference electrode) compared to delirium quantification in frail elderly patients after surgery.~In an international multicenter study, 154 frail elderly patients will be included who will undergo elective surgery and are expected to remain admitted for at least two postoperative days. Patients are excluded if communication is not possible or admitted for neurological surgery.~A five minute EEG registration with the delirium monitor with four electrodes will be performed prior surgery and three consecutive days after surgery or until discharge. Within one hour of the EEG recording, the delirium assessment will be performed and recorded on video, which will be evaluated by delirium experts. The relative delta power (calculated from one minute of artifact-free EEG segment) will be compared with the conclusion of the delirium experts.", - "NCTID": "NCT02404181" - }, - { - "brief_title": "Analysis of Balance in the Aging Process", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Aging']", - "diseases_list": [ - "Aging" - ], - "enrollment": "48.0", - "inclusion_criteria": "inclusion criteria: \n\n Absence of the basic pathology that interferes directly in the balance \n\n ", - "exclusion_criteria": ": \n\n Neurological changes \n\n Cognitive impairment \n\n Orthopedic injury \n\n Use of orthoses for lower limb \n\n Obesity \n\n Exercise frequently (more than twice a week) \n\n The bearer of any commitment to stay in their standing position", - "brief_summary": "Introduction: While growing older, it is possible to notice a decrease in the functional and physiological reserves in the organism which impairs the the abilities in the elderly in doing some tasks. A simple balance becomes a challenge.~Objective: To evaluate the functional balance in the aging process.~Methods: The group was formed by 48 people from 10 to 85 years old. The evaluation instruments are the Berg Balance Scale (BBS), the Performance Oriented Mobility Assessment (POMA), the Unipodal Support Test, the Functional Reach Test and the Romberg's Test.", - "NCTID": "NCT00906711" - }, - { - "brief_title": "Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults", - "phase": "Phase 4", - "drugs": "['donepezil', 'Placebo (cornstarch)']", - "drugs_list": [ - "donepezil", - "Placebo (cornstarch)" - ], - "diseases": "['Mental Health', 'Geriatrics']", - "diseases_list": [ - "Mental Health", - "Geriatrics" - ], - "enrollment": "22.0", - "inclusion_criteria": "inclusion criteria: \n\n valid Ontario driver's license \n\n active driver (greater than or equal to three times per week) \n\n written, informed consent \n\n lives in Toronto/Thunder Bay \n\n healthy \n\n Male between 65-75 years old \n\n ", - "exclusion_criteria": ": \n\n cognitive impairment \n\n psychiatric history \n\n sleep disorder history \n\n substance abuse \n\n neurological history \n\n medical illness \n\n ophthalmological disease \n\n psychoactive medications \n\n contra-indications to Donepezil \n\n experience car/motion sickness", - "brief_summary": "The goal of the study is to assess the role of cholinesterase inhibitors in affecting the driving ability of cognitively intact seniors using driving simulators. We hypothesize that the use of a cholinesterase inhibitor for two weeks will be associated with improvement in safe driving behavior on a simulated driving task.", - "NCTID": "NCT00482001" - } - ], - "1": [ - { - "brief_title": "DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Delirium']", - "diseases_list": [ - "Delirium" - ], - "enrollment": "2500.0", - "inclusion_criteria": "inclusion criteria: \n\n ICU patients aged \u226518 years; \n\n Surgical, medical, neurology/neurosurgical, or trauma patients. \n\n ", - "exclusion_criteria": ": \n\n Delirious at ICU admission; \n\n Expected ICU stay shorter than 6 hours; \n\n Unable to reliably assess ICU delirium due to: \n\n sustained coma during entire ICU stay; \n\n unable to understand the language spoken; \n\n severely mentally disabled; \n\n serious receptive aphasia; \n\n serious auditory or visual disorders.", - "brief_summary": "Currently, two ICU delirium prediction models are available: the PRE-DELIRIC model and the early prediction model (E-PRE-DELRIC). However, the use of these prediction models is not yet implemented as standard in clinical practice, as it is unknown which delirium prediction model can best be used to predict delirium in ICU patients.Therefore the main aim of this study is to compare the performance of the PRE-DELIRIC model and the E-PRE-DELRIC model.", - "NCTID": "NCT02518646" - }, - { - "brief_title": "A Prospective Randomized Study Evaluating the Recurrence Rate of Chronic Subdural Hematoma After Placing a Subperiosteal Drainage Compared to a Subdural Drainage", - "phase": "", - "drugs": "['Subdural Drainage', 'Subperiosteal Drainage']", - "drugs_list": [ - "Subdural Drainage", - "Subperiosteal Drainage" - ], - "diseases": "['Chronic Subdural Hematoma']", - "diseases_list": [ - "Chronic Subdural Hematoma" - ], - "enrollment": "220.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient at least 18 years of age presenting with a symptomatic chronic subdural hematoma \n\n Chronic subdural hematoma verified on cranial CT or MRI \n\n ", - "exclusion_criteria": ": \n\n The surgeon decides based on intraoperative conditions to perform a craniotomy (e.g. acute hematoma indicating a craniotomy) \n\n Chronic subdural hematoma caused by another underlying illness (e.g. caused by over-drainage of a vp-shunt) \n\n no informed consent", - "brief_summary": "The aim of our study is to investigate in randomized controlled fashion whether the recurrence and complication rate, after insertion of subperiosteal drainage in the treatment of chronic subdural haematoma, is higher compared to insertion of subdural drainage.~We hypothesize that patients treated with a subperiosteal drainage do not show higher recurrence rates than those treated with a subdural drainage, and suffer less complications.", - "NCTID": "NCT01869855" - }, - { - "brief_title": "Intelligent Intensive Care Unit", - "phase": "", - "drugs": "['Confusion Assessment Method', 'Accelerometer', 'Commercially available camera', 'Internet Pod (iPod)', 'Cortisol Swab']", - "drugs_list": [ - "Confusion Assessment Method", - "Accelerometer", - "Commercially available camera", - "Internet Pod (iPod)", - "Cortisol Swab" - ], - "diseases": "['Delirium', 'Confusion']", - "diseases_list": [ - "Delirium", - "Confusion" - ], - "enrollment": "130.0", - "inclusion_criteria": "inclusion criteria (ICU Patients): \n\n Intensive care unit patient \n\n 18 years of age or older \n\n ", - "exclusion_criteria": " (ICU Patients): \n\n Anticipated intensive care unit stay less than one day \n\n Less than 18 years of age \n\n Inability to wear a motion sensor watch (ActiGraph) \n\n inclusion criteria (Healthy Controls): \n\n 18 years of age or older. \n\n sleeps in home environment \n\n ", - "brief_summary": "Delirium, as a common complication of hospitalization, poses significant health problems in hospitalized patients. Though about a third of delirium cases can benefit from intervention, detecting and predicting delirium is still very limited in practice. A common characterization of delirium is change in activity level, causing patients to become hyperactive or hypoactive which is manifested in facial expressions and total body movements. This pilot study is designed to test the feasibility of a delirium detection system using movement data obtained from 3-axis wearable accelerometers and commercially available camera with facial recognition video system in conjunction with electronics medical record (EMR) data to analyze the relation of whole-body movement and facial expressions with delirium.", - "NCTID": "NCT02465307" - }, - { - "brief_title": "Evaluation of Rapid Emergency Echography for Acute Dyspnoea", - "phase": "", - "drugs": "['Echocardiography according to the READ method.']", - "drugs_list": [ - "Echocardiography according to the READ method." - ], - "diseases": "['Acute Dyspnea']", - "diseases_list": [ - "Acute Dyspnea" - ], - "enrollment": "500.0", - "inclusion_criteria": "inclusion criteria: \n\n Admission to the Emergency Department Age \u2265 75 years \n\n AND criteria of acute dyspnoea: \n\n Breathe rate \u2265 25 cycles/minute \n\n or PaO2 \u2264 70 mmHg \n\n or SpO2 \u2264 92% in room air \n\n or PacO2 \u2265 45 mmHg and pH \u2264 7.35 AND Electrocardiogram in sinus rhythm at admission \n\n ", - "exclusion_criteria": ": \n\n None", - "brief_summary": "Elderly people constitute the largest proportion of emergency room patients, representing 12% of all emergency room admissions. The need for diagnostic tests or therapeutic interventions is much greater in this patient population. Cardiovascular diseases and symptoms represent 12% of the causes for emergency room admission, and patients suffering from cardiovascular disease are those whose emergency room visit lasts longest.~The diagnostic approach in the emergency room in elderly patients admitted for acute dypsnoea is complex, and early identification of acute left-sided heart failure (ALSHF) is vital as it has an impact on prognosis. The clinical signs are difficult to interpret, and are non-specific, particularly at the acute phase and in elderly or obese patients. Indeed, some authors have reported up to 50% of diagnostic errors in elderly patients.~Measure of the blood concentration of a natriuretic peptide allows a quick diagnosis. However, peptides suffer from several limitations, particularly in situations that are often encountered in elderly patients, such as sepsis, renal failure, acute coronary syndrome, pulmonary embolism, chronic respiratory failure, atrial fibrillation and high body mass index. Diagnostic performance deteriorates with increasing age, and there is a significant increase in this grey-zone in patients aged \u226575 years. In critical situations in elderly patients, assessment of natriuretic peptides serve mainly to rule out a diagnosis of left heart failure.~Some authors have suggested using lung ultrasound in the initial work-up of acute respiratory failure, since some specific profiles are known to be related to the presence of interstitial oedema, reflecting impaired left heart function (e.g. presence of B lines). These studies were performed in the context of intensive or critical care, but data are sparse regarding the application of this approach in the emergency room.~The hypothesis is that the diagnostic accuracy of a targeted and quick echographic approach, namely the READ method (Rapid Echography for Acute Dyspnoea), comprising targeted lung ultrasound combined with isolated measure of transmitral flow, would be superior to that of NT-proBNP assessment for the diagnosis of ALSHF in elderly patients (\u226575 years) admitted to the emergency department.", - "NCTID": "NCT02531542" - }, - { - "brief_title": "Use of Beta Blockers in Elderly Trauma Patients", - "phase": "Phase 2", - "drugs": "['Esmolol', 'Metoprolol']", - "drugs_list": [ - "Esmolol", - "Metoprolol" - ], - "diseases": "['Aged', 'Multiple Trauma', 'Cardiovascular Diseases']", - "diseases_list": [ - "Aged", - "Multiple Trauma", - "Cardiovascular Diseases" - ], - "enrollment": "148.0", - "inclusion_criteria": "inclusion criteria: \n\n All trauma patients admitted to the ICU > 55 years of age with a primary diagnosis of injury will be screened on admission as study candidates. \n\n ", - "exclusion_criteria": ": \n\n Patients will be excluded if they have non-survivable injuries, are receiving comfort care only, have an advanced directive limiting aggressive care, heart block, severe asthma, bradycardia (< 60 bpm), are on beta-blocker therapy, or are having an acute or evolving myocardial infarction.", - "brief_summary": "Advances in medical care have increased the proportion of elderly Americans and enabled them to remain more physically active. This has resulted in an unprecedented increase in the number of geriatric patients admitted to trauma centers. The elderly constitute 23% of trauma center admissions, but 36% of all trauma deaths. This disproportionately high mortality is attributable to a higher prevalence of pre-existing conditions, particularly, cardiac disease. Multi-system injuries result in critical cardiac stress. Although beta-blockade has been shown to decrease morbidity and mortality in patients at risk for myocardial infarction after elective surgery, their use in trauma patients with potential underlying cardiac disease has not been previously studied. We hypothesize that routine administration of beta-blockers after resuscitation will reduce morbidity and mortality in elderly trauma patients with, or at risk for, underlying cardiac disease.~This study is a randomized, prospective clinical trial. One cohort will receive routine trauma intensive care, and the other, the same care plus beta-blockade after completion of resuscitation. The primary outcome will be mortality. Secondary outcomes include MI, length of stay, organ dysfunction, cardiac, and other complications.~Changes in outcome may not be due to reduction in myocardial oxygen demand and heart rate. Laboratory studies demonstrate that circulating inflammatory cytokines contribute to cardiac risk in trauma patients, and their production is influenced by adrenergic stimulation. We will measure circulating IL-6, TNF alpha, IL-1beta, and measure NF-kB and p38 MAP kinase activation in peripheral blood leukocytes, and determine the effect of beta-blockade on the production of these inflammatory markers.~Finally, the wide variation in patient response to beta-blockers is attributed to genetic variability in the adrenergic receptor. Therefore, we will identify single nucleotide polymorphisms (SNPS) within the beta-adrenergic receptor, and determine their effects on mortality and response to beta-blockade. This study will provide the first randomized, prospective trial designed to reduce morbidity and mortality in elderly trauma patients at risk for cardiac disease. The laboratory and genetic component will provide additional insights that may explain treatment effects, lead to new therapeutic strategies, and have the potential to lead to additional areas of investigation.", - "NCTID": "NCT00302692" - } - ], - "2": [ - { - "brief_title": "Imaging of Traumatic Brain Injury", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Traumatic Brain Injury']", - "diseases_list": [ - "Traumatic Brain Injury" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 or older \n\n Evidence of external head injury or facial trauma, or mechanism of injury consistent with brain trauma, including loss of consciousness or altered mental status. \n\n Residence within 90 minutes driving time of University of Maryland Medical Center, and willingness to attend follow-up appointments. \n\n ", - "exclusion_criteria": ": \n\n History of white matter disease or neurodegenerative disorders including Multiple Sclerosis, Huntington's Disease, Alzheimer's Disease, or Pick's Disease. \n\n History of Stroke \n\n History of treatment or diagnosis of psychiatric conditions: Major Depressive Disorder (MDD), Bipolar Disorder (BPD), Schizophrenia, or Dementia of any type. \n\n History of Brain Tumor \n\n Status post trauma due to asphyxiation \n\n Preexisting contraindications for Magnetic Resonance Imaging (MRI) \n\n Active Duty Military Status \n\n Police custody or prisoner status \n\n Pregnant women", - "brief_summary": "This project aims to study the prognostic ability of various MRI imaging markers in the evaluation of TBI patients. Cognitive, social, and occupational recovery will be measured at each time point, and compared to MRI findings. Healthy volunteers will serve as a comparison to the TBI patients.~It is hypothesized that novel MRI markers of metabolism, hemodynamics, functional connectivity, and tissue microstructure will be related to the clinical status of the patient, as well as their social and occupational outcomes.", - "NCTID": "NCT01196299" - }, - { - "brief_title": "Characteristics of Blood- Brain Barrier Permeability in Neurological Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Traumatic Brain Injury', 'Cerebral Infarction', 'Cerebral Hemorrhage']", - "diseases_list": [ - "Traumatic Brain Injury", - "Cerebral Infarction", - "Cerebral Hemorrhage" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n One week following: \n\n Traumatic Brain Injury \n\n Cerebro- Vascular Accident \n\n Subsequent brain CT showed cerebral cortex injury. \n\n ", - "exclusion_criteria": ": \n\n A known ailment of the central nervous system. \n\n Use of medications or illicit drugs that significantly affect the central nervous system. \n\n tourist or temporary residents not available for follow-up. \n\n For MRI examinations: heart pacemaker, metal implants, or metal shrapnel.", - "brief_summary": "The main goal of the present study is to challenge the hypothesis that blood- brain barrier disruption following brain injury increases the risk for long-term disability, development of brain dysfunction, epileptic seizures and neuroanatomical alterations.", - "NCTID": "NCT00419874" - }, - { - "brief_title": "Multimodal Neurodiagnostic Imaging of Traumatic Brain Injury and Post-Traumatic Stress Disorder", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Traumatic Brain Injury', 'Post-Traumatic Stress Disorder']", - "diseases_list": [ - "Traumatic Brain Injury", - "Post-Traumatic Stress Disorder" - ], - "enrollment": "224.0", - "inclusion_criteria": "inclusion criteria: \n\n At least 18 years of age and non-active duty \n\n Either: \n\n Normal (no history of head injury) -OR- \n\n TBI (injury since Jan. 1, 2002) \n\n ", - "exclusion_criteria": ": \n\n Incapable of informed consent or absence of legally authorized representative. \n\n Incarcerated (or subject to court supervision). \n\n Known allergy to protocol contrast/imaging agent (or pregnant and unable to receive agent) \n\n MRI incompatible (i.e. implant, metal, > 300 lbs, severe claustrophobia)", - "brief_summary": "The purpose of this study is to determine whether the brains of persons with and without traumatic brain injury differ in a meaningful way when advanced technology images of the brain are taken using three newer technologies that visualize the brain using a combination of external/internal magnetic fields and radioactive tracers (molecules that emit detectable particles). The hope is that the results of this study will validate tools (help prove that diagnostic tools actually detect disease) for the diagnosis and treatment of traumatic brain injuries (TBI).", - "NCTID": "NCT01075035" - }, - { - "brief_title": "The Neuromarker S-100B in Patients With Different Types of Intracranial Injury", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Traumatic Brain Injury', 'Trauma']", - "diseases_list": [ - "Traumatic Brain Injury", - "Trauma" - ], - "enrollment": "1800.0", - "inclusion_criteria": "inclusion criteria: \n\n all patients with traumatic brain injury \n\n ", - "exclusion_criteria": ": \n\n patients without traumatic brain injury", - "brief_summary": "Abstract:~The most widely studied neuro-markers in traumatic brain injury (TBI) are S100B and neurone specific enolase (NSE). S-100B is localized in astroglia. This marker is used to predict neuronal damage caused by traumatic brain injury. The investigators conduct a study to derive and validate the measurement of S-100B in serum of patients with different types traumatic brain injuries.", - "NCTID": "NCT01619293" - }, - { - "brief_title": "The DETEcT Study - Delirium in Elderly paTiEnts Admitted to Trauma", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Delirium', 'Bone Fractures', 'Multiple Trauma']", - "diseases_list": [ - "Delirium", - "Bone Fractures", - "Multiple Trauma" - ], - "enrollment": "672.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with any medical condition with an age of 65 years and older \n\n ", - "exclusion_criteria": ": \n\n Impossibility to give an informed consent; refusal", - "brief_summary": "Primary objectives are to define incidence and prevalence of Delirium in an elderly population admitted to the Department of Orthopedics and Traumatology and, in the postoperative phase, in the high Dependency Unit as well as to determine the presence of risk factors. Secondary objectives are to determine mean hospital stay, rates of complications as well as in-hospital mortality and at 1-3 and 12 months after discharge, functional recovery and cognitive outcomes at 1, 3 and 12 moths follow-up.", - "NCTID": "NCT02086981" - }, - { - "brief_title": "To Scan or Not to Scan: The Role of Follow-up CT Scanning for Management of Chronic Subdural Hematoma After Neurosurgical Evacuation", - "phase": "", - "drugs": "['cranial CT scan']", - "drugs_list": [ - "cranial CT scan" - ], - "diseases": "['Chronic Subdural Hematoma']", - "diseases_list": [ - "Chronic Subdural Hematoma" - ], - "enrollment": "368.0", - "inclusion_criteria": "inclusion criteria: \n\n Newly diagnosed chronic subdural hematoma by CT scan or MRI, operated within the last 48 hours \n\n Age 18 years or older \n\n Written informed consent from the patient to participate in the study \n\n ", - "exclusion_criteria": " \n\n Moribund state of health prohibiting surgery \n\n Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad) \n\n Recurrent hematoma if the first surgery was performed before study start \n\n CSH due to spontaneous spinal CSF fistula or meningeosis carcinomatosa \n\n Pregnancy \n\n Patient with Metastatic Disease and a high possibility to pass away in the next 6 month", - "brief_summary": "Chronic subdural hematoma (CSH) is one of the most common bleedings of the head. These hematomas develop after minor head trauma and increase in size over weeks. Patients usually present with headaches, gait disturbances, language problems or confusion. The state of the art treatment of a symptomatic chronic subdural hematoma is to remove the hematoma by burr hole trepanation.~The optimal follow-up for operated patients remains controversial. Due to the known high rate of a second hematoma at the same place (usually within weeks), one strategy is to perform serial computer tomography scans in order to identify recurrent hematomas early. The radiologic evidence of a second hematoma often leads to reoperation, even if the patient has no, or just slight symptoms. Another strategy after surgical hematoma evacuation is to closely follow the patient with neurological examinations and perform neuroimaging only in case of new symptoms. Advocators of this strategy argue that a follow-up with routine CT scans may be harmful due to additional and maybe unnecessary surgeries and hospital days in a patient population marked by advanced age and fragility.~The aim of the current study is to evaluate the role of computer tomography scanning in the postoperative follow-up after removal of a chronic subdural hematoma. Participants of this study will be allocated by chance to one of two study groups: Patients allocated to group A will receive a computer tomography scan on day 2 and again on day 30 after surgery in addition to a clinical examination. Patients allocated to group B will be examined clinically on day 2 and day 30 without computer tomography. All patients will undergo a final clinical examination after 6 months. The study will recruit 400 patients.", - "NCTID": "NCT01624545" - } - ] - }, - { - "patient_id": "sigir-201415", - "patient": "A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.", - "0": [ - { - "brief_title": "Natural History Study of Moles and Suspicious Melanoma", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Melanocytic Nevi', 'Acquired Melanocytic Nevi', 'Primary Cutaneous Melanoma']", - "diseases_list": [ - "Melanocytic Nevi", - "Acquired Melanocytic Nevi", - "Primary Cutaneous Melanoma" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Infants/Children \n\n Must be less than or equal to 5 years. \n\n Must have large congenital melanocytic nevus (LCMN, diagnosed clinically or by biopsy) that is greater than 20 cm in any one dimension or that is greater than 8 cm in any one dimension involving the scalp. \n\n Must have outside referring physician. \n\n OR \n\n Adults \n\n Must be greater than 18 years. \n\n Must have greater than or equal to 100 melanocytic nevi greater than 2 mm in diameter. \n\n Must have at least one melanocytic nevus greater than or equal to 4 mm in longest dimension. \n\n Can have prior history of cutaneous or ocular malignant melanoma. \n\n Must have outside primary physician. \n\n OR \n\n Adults \n\n Must be greater than 18 years. \n\n Must have a current pigmented lesion clinically suspicious for primary melanoma. \n\n Must have outside primary physician. \n\n AND \n\n All patients, or in the case of infants and children their parents or legal guardians, must be able to understand and sign an informed consent. \n\n ", - "exclusion_criteria": ": \n\n The patient does not meet the inclusion criteria. \n\n Diagnosis of genetic syndrome associated with multiple lentigines or nevi (Peutz-Jeghers syndrome, Carney complex, turner syndrome, Noonan's syndrome). \n\n Two or more first-degree relatives with history of cutaneous melanoma and familial atypical mole-melanoma syndrome phenotype. \n\n Diagnosis of cancer-associated syndrome (xeroderma pigmentosum, type I neurofibromatosis, Li-Fraumeni syndrome). \n\n Inability to tolerate surgical procedure due to bleeding diathesis or disorder or other cause as determined by principal investigator. \n\n Patient is unwilling to consider elective biopsy of a melanocytic nevus.", - "brief_summary": "Background:~Melanocytic nevi, or moles, are non-cancerous growths of a type of skin cell called a melanocyte.~Large congenital melanocytic nevi (LCMN) are a special type of mole that begins to grow before birth and is larger than moles that develop after birth.~Determining how melanocytes in moles and LCMNs differ from normal melanocytes may increase the ability to predict whether a mole will give rise to a melanoma (a type of skin cancer)~Objectives:~To understand how melanomas develop, by studying moles, LCMNs, and pigmented skin lesions that are suspicious for melanoma~To develop better criteria for diagnosing melanoma, particularly by using a device called a digital dermatoscope (a special camera, connected to a computer, that takes pictures of moles when they are magnified and illuminated)~Eligibility:~Children 5 years old or older with an LCMN~Adults 18 years old or older with 100 or more moles larger than 2 mm in diameter and at least one 4 mm or more~Adults 18 years old or older with a pigmented lesion suspicious for melanoma~Design:~Patients' personal and family health history is obtained.~Patients are examined by investigative team doctors, and several lesions are examined with a dermatoscope.~Additional photographs of part or all of the skin surface may be taken.~Some lesions may be biopsied.~Additional tests or examinations may be recommended.~Patients are followed periodically for skin or physical examinations, photography, laboratory and imaging evaluations, and possible skin biopsies.~Children may undergo brain magnetic resonance imaging (MRI)", - "NCTID": "NCT00288938" - }, - { - "brief_title": "The Use of Mole Mapping Diagrams to Increase Skin Self Examination Accuracy", - "phase": "", - "drugs": "['Mole Mapping Diagram']", - "drugs_list": [ - "Mole Mapping Diagram" - ], - "diseases": "['Melanoma']", - "diseases_list": [ - "Melanoma" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Male and female subjects above age 18 of any ethnicity will be enrolled in this study. \n\n ", - "exclusion_criteria": ": \n\n Subjects will be excluded from the study if they have significant skin disease which would not allow manipulation of their photographs consistent with the rest of the subjects. \n\n Since the study instructions are in English, Non-English speakers will be excluded. \n\n Those with co-morbidity sufficiently severe to prevent them from being able to perform a SSE will be excluded. \n\n In addition, those with cognitive impairment who are unable to give informed consent, or to understand the study instructions given to them, will be excluded.", - "brief_summary": "This study aims to improve Skin Self-Examination accuracy by a simple cost effective intervention requiring participants to complete a mole-mapping diagram.", - "NCTID": "NCT00237965" - }, - { - "brief_title": "Treatment of Uterine Fibroids With CDB-2914, an Experimental Selective Progesterone Receptor Antagonist", - "phase": "Phase 2", - "drugs": "['CDB-2914']", - "drugs_list": [ - "CDB-2914" - ], - "diseases": "['Leiomyoma']", - "diseases_list": [ - "Leiomyoma" - ], - "enrollment": "56.0", - "inclusion_criteria": "GENERAL inclusion criteria: \n\n Women receiving insulin or thyroid hormone replacement may participate if well-controlled; use of vitamins and calcium under RDA is allowed. \n\n Female gender-to evaluate effects in the target population for clinical trials. \n\n In good health. Chronic medication use is acceptable except for glucocorticoid use. Other chronic medication use may be acceptable at the discretion of the research team. Interval use of over-the counter drugs is acceptable but must be recorded. \n\n Menstrual cycles of 24 - 35 days. \n\n Hemoglobin greater than 10 g/dL. \n\n Willing and able to comply with study requirements. \n\n Age 33 to 50. \n\n Using mechanical (condoms, diaphragms), sterilization or abstinence methods of contraception for the duration of the study. \n\n Negative urine pregnancy test. \n\n BMI less than or equal to 33. \n\n Able to read and speak English fluently to allow accurate self-administration of medication, recording of symptoms and unassisted completion of questionnaire. \n\n Normal glomerular filtration rate. \n\n Liver function tests within 130% of upper limit. \n\n inclusion criteria FOR WOMEN WITH LEIOMYOMA: \n\n History of uterine leiomyoma causing symptoms of bleeding, pressure, or pain, as defined by the ACOG practice bulletin (ACOG Practice Bulletin 1994): \n\n Excessive uterine bleeding will be evidenced by either of the following-profuse bleeding with flooding or clots or repetitive periods lasting for more than 8 days; or anemia due to acute or chronic blood loss; OR \n\n Pelvic discomfort caused by leiomyomata, either acute and severe or chronic lower abdominal or low back pressure or bladder pressure with urinary frequency not due to urinary tract infection. \n\n Uterine leiomyoma(ta) of at least 2 cm size. \n\n No desire for fertility; willing to undergo hysterectomy. \n\n GENERAL ", - "exclusion_criteria": ": \n\n Significant abnormalities in the history, physical or laboratory examination. \n\n Pregnancy. \n\n Lactation. \n\n Use of oral, injectable or inhaled glucocorticoids or megesterol within the last year. \n\n Unexplained vaginal bleeding. \n\n History of malignancy within the past 5 years. \n\n Use of estrogen or progesterone-containing compounds, such as oral contraceptives and hormone replacement therapy, within 8 weeks of study entry, including transdermal, injectable, vaginal and oral preparations. \n\n Use of agents known to induct hepatic P450 enzymes; use of imidazoles. \n\n Current use of GnRH analogs or other compounds that affect menstrual cyclicity. \n\n FSH greater than 20 IU/mL. \n\n Significant medical disorders. \n\n Cervical dysplasia. \n\n Need for interval use of narcotics. \n\n Abnormal adnexal/ovarian mass. \n\n Intrauterine device. \n\n ", - "brief_summary": "Uterine leiomyomata (fibroids) are a common benign tumor of the uterine muscle in premenopausal women. These tumors may cause bleeding, pelvic pain and pressure. Because fibroids grow in the presence of estrogen, medical therapies that decrease estrogen levels (like GnRH analog) cause fibroids to shrink and so may relieve symptoms. However, such medication can only be given short-term and has inconvenient side effects such as hot-flushes. Thus, many women with symptomatic fibroids choose to have them removed surgically, either individually or by removing the uterus via hysterectomy.~The study evaluates a new medical treatment for fibroids using the progesterone receptor modulator CDB-2914. A similar compound, mifepristone (Registered Trademark), reduced fibroid size when given for twelve weeks. This study will compare fibroid size, hormone levels and symptoms before and during daily administration of CDB-2914 (10 or 25 mg) or placebo for 10 - 14 weeks. To do this, women will undergo MRI and a saline hysterosonogram (ultrasound with fluid) of the uterus before and at the end of the treatment; they will have blood drawn every 7 - 14 days, and will fill out a symptom calendar at home. Hysterectomy will be performed at the end of the treatment to evaluate the effects of the medication on the uterine and fibroid tissues, and to provide treatment for the study participant. Women will be randomly assigned to the treatment groups; during the treatment period neither the participants nor the investigators will know the type of treatment that a woman receives.~...", - "NCTID": "NCT00044876" - }, - { - "brief_title": "Comparison Study in the Treatment of Uterine Fibroids Uterine Fibroid Embolization Using BeadBlock\u2122 Embolic Agent", - "phase": "Phase 1", - "drugs": "['Uterine fibroid embolization BeadBlock\u2122', 'Uterine fibroid embolization Embosphere\u00ae']", - "drugs_list": [ - "Uterine fibroid embolization BeadBlock\u2122", - "Uterine fibroid embolization Embosphere\u00ae" - ], - "diseases": "['Leiomyoma', 'Leiomyomatosis', 'Uterine Neoplasms']", - "diseases_list": [ - "Leiomyoma", - "Leiomyomatosis", - "Uterine Neoplasms" - ], - "enrollment": "44.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient chooses to participate and has signed informed consent \n\n Age between 30 and 50 years old \n\n Symptoms caused by uterine fibroids, such as heavy bleeding (menorrhagia) and/or bulk-related complaints such as urinary frequency, constipation or pelvic pain. \n\n Patient has fibroids confirmed by MRI \n\n Patient has normal kidney function. \n\n Patient is willing and able to undergo follow-up imaging at 3 and 6 months post UFE. \n\n ", - "exclusion_criteria": ": \n\n Patients who are pregnant or plan to become pregnant within the study period, or desire future fertility. \n\n Patients with a history of gynecologic malignancy \n\n Patients with known endometrial hyperplasia \n\n Patients with adenomyosis \n\n Patients with pelvic inflammatory disease \n\n Patients with Uteri < 250 ml (cm) calculated volume or > 24 weeks \n\n Patients with pedunculated subserosal fibroids with a narrow attachment (<50% diameter of the fibroid) to the uterus. \n\n Patients with pelvic pain as dominant syndrome \n\n Known allergy to contrast media that cannot be adequately pre-medicated. \n\n Patients not suitable for arterial access. \n\n Previous uterine artery embolization attempts. \n\n History of pelvic irradiation. \n\n Patients on GnRH Therapy within 3-6 months prior to the study enrollment.", - "brief_summary": "A double arm (non-inferiority) 44 patient study to assess the performance of BeadBlock\u2122 in the treatment of uterine fibroids by embolization with respect to clinical & imaging outcome with comparison of primary safety endpoints to Embosphere.", - "NCTID": "NCT00361036" - }, - { - "brief_title": "Safety of Treatment of Uterine Fibroids With Asoprisnil", - "phase": "Phase 3", - "drugs": "['Asoprisnil', 'Asoprisnil']", - "drugs_list": [ - "Asoprisnil", - "Asoprisnil" - ], - "diseases": "['Fibroid Uterus', 'Leiomyoma', 'Menorrhagia', 'Metrorrhagia', 'Uterine Fibroids']", - "diseases_list": [ - "Fibroid Uterus", - "Leiomyoma", - "Menorrhagia", - "Metrorrhagia", - "Uterine Fibroids" - ], - "enrollment": "166.0", - "inclusion_criteria": "inclusion criteria: \n\n Women that have completed 6 months of treatment in study C02-037 with no more than a 7-day interruption in their treatment \n\n Otherwise good health \n\n Premenopausal based on Estrogen and Follicle Stimulating Hormone levels \n\n Agrees to double-barrier method of contraception \n\n Adequate endometrial biopsy with no significant histological disorder \n\n ", - "exclusion_criteria": ": \n\n Any abnormal lab or procedure result(s) the study-doctor considers important \n\n History of a blood-clotting disorder \n\n Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away \n\n Significant gynecological disorder, such as endometrial polyp", - "brief_summary": "The objective of this study is to determine the long-term safety of asoprisnil in women with symptomatic uterine fibroids who completed the 6 month Study C02-037.", - "NCTID": "NCT00156208" - }, - { - "brief_title": "A Study to Evaluate the Safety and Efficacy of Single Day or Single Dose Famciclovir for the Treatment of Recurrent Herpes Labialis", - "phase": "Phase 4", - "drugs": "['Famciclovir']", - "drugs_list": [ - "Famciclovir" - ], - "diseases": "['Recurrent Herpes Labialis']", - "diseases_list": [ - "Recurrent Herpes Labialis" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Patients aged 18 years or older \n\n A history typical for recurrent herpes labialis. The subject must have experienced three or more episodes of cold sores in the last 12 months, and have a history of prodromal symptoms, as defined by the patient, preceding at least 50% of these cold sores, and must also have a history of vesicular lesions in at least 50% of the recurrent episodes of cold sores. \n\n General good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient's account of his/her medical history \n\n Women of child bearing potential had to use an accepted method of birth control (surgical sterilization; intra-uterine contraceptive device; oral contraceptives; hormone delivery systems such as Norplant\u00ae or Depo-Provera injections; a diaphragm in combination with contraceptive cream, jelly, or foam; or a condom in combination with contraceptive cream, jelly or foam). Patients unable or unwilling to use one of the methods of birth control listed above for the duration of the study could not enter the study. \n\n For women of child-bearing potential, a negative pregnancy test (urine) at screening was required \n\n Signature on the informed consent document \n\n ", - "exclusion_criteria": ": \n\n Previous herpes vaccination \n\n Patients using topical immunosuppressive agents (including steroids, tacrolimus and pimecrolimus) on or near the face or systemic immunosuppressive agents (including steroids, tacrolimus and pimecrolimus) within 30 days of screening \n\n Patients known to be immunosuppressed due to underlying disease (e.g. HIV infection) or concomitant treatment (e.g. cancer chemotherapy) \n\n Recent history of alcohol or drug abuse, which in the opinion of the investigator, could interfere with that study patient's compliance with study requirements \n\n Significant skin disease such as atopic dermatitis or eczema that would interfere with the assessment of lesions \n\n Allergy or hypersensitivity to formulations containing acyclovir, penciclovir, famciclovir, and/or other nucleoside analogues \n\n Women who were lactating or breast feeding \n\n Had already been randomized once into the study \n\n Patients who had received an investigational drug in the past four weeks", - "brief_summary": "The study is designed to assess the efficacy and safety of patient-initiated therapy with famciclovir 1500 mg o.d. or 750 mg b.i.d. for one day treatment in adult men and women with recurrent herpes labialis", - "NCTID": "NCT00248144" - } - ], - "1": [ - { - "brief_title": "Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia", - "phase": "Phase 3", - "drugs": "['Dactinomycin', 'Methotrexate']", - "drugs_list": [ - "Dactinomycin", - "Methotrexate" - ], - "diseases": "['Good Prognosis Metastatic Gestational Trophoblastic Tumor', 'Hydatidiform Mole', 'Non-Metastatic Gestational Trophoblastic Tumor', 'Uterine Corpus Choriocarcinoma']", - "diseases_list": [ - "Good Prognosis Metastatic Gestational Trophoblastic Tumor", - "Hydatidiform Mole", - "Non-Metastatic Gestational Trophoblastic Tumor", - "Uterine Corpus Choriocarcinoma" - ], - "enrollment": "240.0", - "inclusion_criteria": "inclusion criteria: \n\n Histologically proven low-risk gestational trophoblastic neoplasia (persistent hydatidiform mole or choriocarcinoma), defined as 1 of the following: \n\n Less than 10% decrease in the beta human chorionic gonadotropin (HCG) titer over 3 weekly titers \n\n Greater than 20% sustained rise in beta HCG titer over two consecutive weeks \n\n Persistently elevated beta HCG titer more than 4 months after initial curettage (greater than 5 mIU/mL minimum) \n\n Histologically proven nonmetastatic choriocarcinoma \n\n Metastases to vagina, parametria, or lung (if no single pulmonary lesion is greater than 2 cm) \n\n WHO score 0-6 (not including blood group or CT lung) \n\n No histologically confirmed placental site pseudotumor \n\n Must have undergone at least 1 uterine curettage \n\n Previously untreated disease \n\n Performance status - GOG 0-2 \n\n WBC at least 3,000/mm^3 \n\n Granulocyte count at least 1,500/mm^3 \n\n Platelet count at least 100,000/mm^3 \n\n Bilirubin no greater than 1.5 times upper limit of normal (ULN) \n\n SGPT and SGOT no greater than 3 times ULN \n\n Alkaline phosphatase no greater than 3 times ULN \n\n No significant prior abnormal hepatic function \n\n Creatinine no greater than 2.0 mg/dL \n\n No significant prior abnormal renal function \n\n Not pregnant or nursing \n\n Fertile patients must use effective contraception during and for one year after study entry \n\n No other prior or concurrent malignancies within the past 5 years except nonmelanomatous skin cancer \n\n No prior chemotherapy for gestational trophoblastic neoplasia \n\n No concurrent curettage except as needed to control vaginal bleeding or to rule out placental site pseudotumor", - "exclusion_criteria": "", - "brief_summary": "Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia.", - "NCTID": "NCT00003702" - }, - { - "brief_title": "Safety Trial of Magnetic Resonance (MR) Guided Focused Ultrasound Surgery (FUS) in Women With Uterine Fibroids Wishing to Pursue Pregnancy in the Future", - "phase": "Phase 4", - "drugs": "['Magnetic Resonance Guided Focused Ultrasound']", - "drugs_list": [ - "Magnetic Resonance Guided Focused Ultrasound" - ], - "diseases": "['Uterine Fibroids', 'Pregnancy']", - "diseases_list": [ - "Uterine Fibroids", - "Pregnancy" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n 1. Subject with uterine fibroids, who desire pregnancy within 12 months and has the one of the following criteria: Women 20-40 age. Women age < 46 years old who plan to have egg donation. Women above 38 should test for normal ovarian function as judged by endocrinological evaluation. \n\n If the couple has failed to conceive for more that 1 year, the woman should test for normal ovarian function as judged by endocrinological evaluation, and the male must have adequate sperm test. \n\n Women undergoing fertility treatment or plan to have sperm donation. \n\n 2. Use or non use of non-steroidal treatments for excessive vaginal bleeding such as antifibrinolytic agents (e.g. Tranexamic acid) or non-steroidal anti-inflammatory drugs (e.g. Mefanamic Acid) has been maintained for the three months prior to the planned date of the study procedure and the patient has agreed to maintain this use or non-use through the 6-month follow-up period. \n\n 3. Clinically normal PAP smear within timing of National Guidelines in the country of the clinical site. \n\n 4. Able and willing to give consent and able to attend all study visits \n\n 5. Able to communicate sensations during the MRgFUS procedure \n\n 6. Having uterine fibroids that are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone). \n\n 7. Tumor(s) are clearly visible on non-contrast MRI. \n\n 8. Largest fibroid 8 cm in diameter or 12 cm if receiving GnRH \n\n ", - "exclusion_criteria": ": \n\n 1. Patient is pregnant as confirmed by pregnancy test at time of screening \n\n 2. Uterine size >20 weeks as evaluated by US or MR. \n\n 3. Patients who are considered high risk pregnancy due to uterine factors (e.g. abnormal uterus, uterine scars, cerclage) except fibroids. \n\n 4. Patients with fibroid that is more than 50% sub-mucosal or with hysteroscopically resectable \n\n 5. Patients with adenomyosis \n\n 6. Patient is on dialysis \n\n 7. Hematocrit is < 25 \n\n 8. Patient has hemolytic anemia \n\n 9. Patient has unstable cardiac status including: \u00a7 Unstable angina pectoris on medication\u00a7 Documented myocardial infarction within 6 months of protocol entry\u00a7 Congestive heart failure requiring medication (other than diuretic)\u00a7 Currently taking anti-arrhythmic drugs\u00a7 Severe hypertension (diastolic BP>100 on medication)\u00a7 Presence of cardiac pacemaker \n\n 10. Patient has an ASA score of >2 \n\n 11. Patient has severe cerebrovascular disease (multiple CVA or CVA within 6 months) \n\n 12. Patient is on anti-coagulation therapy or has an underlying bleeding disorder \n\n 13. Evidence of uterine pathology other than leiomyoma \n\n 14. Patient has an active pelvic infection or history of pelvic inflammatory disease \n\n 15. Patient has an undiagnosed pelvic mass outside the uterus. \n\n 16. Patient weight >110 kg \n\n 17. Subject with extensive abdominal scarring in an area of the abdomen directly anterior to the treatment area. \n\n 18. Subject with standard contraindications for MR imaging such as non-MRI compatable implanted metallic devices. \n\n 19. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist). \n\n 20. Individuals who are not able or willing to tolerate the required prolonged stationary prone position during treatment (approximately 3 hours.) \n\n 21. Patient with an intrauterine contraceptive device anywhere in the treatment beam path. \n\n 22. Women who are breast feeding. \n\n 23. Five or more fibroids, bigger then 3cm diameter, each", - "brief_summary": "The study objective is to develop data for the safety of pregnancies after thermal ablation of uterine fibroids by MR guided Focused Ultrasound using the Ex Ablate 2000 system.", - "NCTID": "NCT00180739" - }, - { - "brief_title": "Fibroid Growth Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Uterine Leiomyomas']", - "diseases_list": [ - "Uterine Leiomyomas" - ], - "enrollment": "123.0", - "inclusion_criteria": "inclusion criteria: \n\n Women included in the study must be at least 18 years if age, premenopausal, speak English, and have one or more uterine leiomyomas at least 2 cm in diameter and the utuerus must be enlarged to the size typical during the 8th week of pregnancy. Note that while the selcetion criteia are set to recruit women in which surgical intervention is a likely outcome, surgery is not a requirement for study inclusion. \n\n ", - "exclusion_criteria": ": \n\n Women will be excluded if they are pregnant because of potential safety concerns associated with imaging and image contrast enhancements. If women become pregnant during the study, they wil have the option to stay in the study, but will have pelvic ultrasound scans in place of MRI scans. \n\n Women who are taking or likely to start taking GnRH therapy will be excluded because this therapy, which is used as a treatment method for leiomyomas, sometmes induces their regression. \n\n Women who are greater than 52 inches in circumference or greater than 350 pounds will be excluded because they will be too large to fit in the imaging equipment. \n\n Women that have an intra-uterine device (IUD) will be excluded because these metal devices create 'shadowing' in MR images, making accurate measurement and interpretation of leiomyomas in the MRIs difficult. \n\n Women are not excluded if they had a prior myomectomy, or if they are taking oral contraceptives. \n\n The inclusion of only women of premenopausal age (greater than 18 years old) in this study is dictated by the nature of the condition.", - "brief_summary": "Uterine leiomyomas, commonly called fibroids, are a major health concern for women of reproductive age. The objectives of the study described herein are to investigate the growth dynamics of uterine leiomyomas in a clinically relevant population of women. We will test the hypotheses that uterine leiomyomas are heterogeneous in terms of their growth characteristics and in their clinical symptoms or outcomes, and that differences in leiomyoma growth dynamics can be discriminated by molecular markers and cellular phenotypes. Participants will include 300 premenopausal women (greater than 18 years old) with at least one uterine leiomyoma. The inclusion criteria for patient enrollment is confirmed diagnosis of leiomyoma by ultrasound. At least one leiomyoma must be equal to or greater than 2 cm in diameter and the uterus must be enlarged to the size typical during the eigth week of pregnancy. After enrollment and informed consent, T1- and T2-weighted magnetic resonance image (MRI) scans will be conducted beginning at the first visit and then at 3, 6, and 12 months. Each patient will have a physical exam, provide urine and blood samples at each MRI visit, and respond to an initial extensive telephone-administered questionnaire followed by abbreviated monthly questionnaire updates. A number of the enrolled women will require surgical intervention (hysterectomy/myomectomy) as standard care. If surgery is an outcome for women enrolled in the study, MRI will be conducted before surgery and the surgical pathologist will map uterine leiomyomas for comparison to MRI. Leiomyoma samples will be analyzed for histopathological and molecular changes correlated with growth. Because hysterectomy and myomectomy are common outcomes in women with leiomyomas, we anticipate tissue will be available from at least 100 of the 300 women in the study. For those women who opt for surgery, we will also administer a brief (less than 5 minute) questionnaire clarifying their reason for electing surgery. Upon completion of data collection, we will be able to compare leiomyoma growth as a function of multiplicity and location; examine the relationship between leiomyoma growth and clinical symptoms or outcome; identify molecular, cellular, and pathological characteristics of leiomyomas with differing growth dynamics; and examine endocrinological parameters and lifestyle factors related to differential growth dynamics of uterine leiomyomas. The data may be used to establish a clinical severity scale and establish diagnostic markers currently not available for uterine leiomyomas.", - "NCTID": "NCT00340288" - }, - { - "brief_title": "A Study to Evaluate the Effects of Asoprisnil(J867) in Women With Uterine Fibroids Who Are Scheduled for a Hysterectomy", - "phase": "Phase 2", - "drugs": "['Asoprisnil', 'Asoprisnil', 'Placebo']", - "drugs_list": [ - "Asoprisnil", - "Asoprisnil", - "Placebo" - ], - "diseases": "['Uterine Fibroids', 'Leiomyoma']", - "diseases_list": [ - "Uterine Fibroids", - "Leiomyoma" - ], - "enrollment": "33.0", - "inclusion_criteria": "inclusion criteria: \n\n Premenopausal women, at least 18 years of age \n\n Diagnosis of uterine fibroid(s), confirmed by ultrasound \n\n History of menstrual cycles between 17 and 42 days \n\n Otherwise in good health \n\n Scheduled for a hysterectomy at the end of the treatment period \n\n Negative pregnancy test \n\n Agrees to double barrier method of contraception \n\n Pap test with no evidence of malignancy or pre-malignant changes \n\n Endometrial biopsy with no significant histological disorder \n\n ", - "exclusion_criteria": ": \n\n Less than 3 months after having a baby or breast-feeding \n\n Any abnormal lab or procedure result the study-doctor considers important \n\n Severe reaction(s) to or are currently using any hormone therapy \n\n History of cancer or alcohol or drug abuse \n\n Diagnosis of Polycystic Ovary Syndrome \n\n History of prolactinoma \n\n Current use of Intrauterine Device \n\n Significant gynecological disorder \n\n Uterine size > 32 weeks gestation \n\n Current diagnosis of endometriosis \n\n Uterine artery embolization within 6 months", - "brief_summary": "The objective of this study is to evaluate the effects of 10 mg and 25 mg doses of asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the morphology of the endometrium and uterine fibroids.", - "NCTID": "NCT00150644" - } - ], - "2": [ - { - "brief_title": "Detection of Human Chorionic Gonadotropin by Interferometry in Gestational Trophoblastic Disease", - "phase": "", - "drugs": "['chemotherapy agents', 'suction curettage']", - "drugs_list": [ - "chemotherapy agents", - "suction curettage" - ], - "diseases": "['Trophoblastic Neoplasms']", - "diseases_list": [ - "Trophoblastic Neoplasms" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Hydatidiform Mole \n\n Choriocarcinoma \n\n Gestational Trophoblastic Neoplasms \n\n ", - "exclusion_criteria": ": \n\n Unwilling to participate in the study", - "brief_summary": "We will try to use the novel analytical technique -Dual Polarisation Interferometry (DPI),to achieve detection the minimal amount of the human chorionic gonadotropin for early detection and strict monitor of the GTD.", - "NCTID": "NCT00166790" - }, - { - "brief_title": "A Trial for Patients With Gestational Trophoblastic Disease", - "phase": "Phase 2", - "drugs": "['Pemetrexed']", - "drugs_list": [ - "Pemetrexed" - ], - "diseases": "['Trophoblastic Neoplasms', 'Uterine Neoplasms', 'Hydatidiform Mole', 'Choriocarcinoma']", - "diseases_list": [ - "Trophoblastic Neoplasms", - "Uterine Neoplasms", - "Hydatidiform Mole", - "Choriocarcinoma" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Persistent or recurrent low risk Gestational Trophoblastic Tumor (GTT) \n\n WHO score 2-6 (re-evaluated at the time of relapse \n\n Histologically confirmed complete or partial moles on initial evacuation \n\n Patients with mild to moderate renal insufficiency should avoid taking NSAIDs with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed. \n\n All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration. \n\n Folic Acid (350-1000 micrograms) must be given daily beginning approximately 5-7 days prior to first dose of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy. \n\n Vitamin B12 (1000 micrograms) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy. \n\n ", - "exclusion_criteria": ": \n\n Previous treatment that included chemotherapy other than actinomycin -D or methotrexate (+/- folinic acid). \n\n Patients with more than 8 metastatic lesions identified \n\n Patients with metastases to liver, spleen, brain, kidney or GI tract", - "brief_summary": "This phase II study is evaluating the activity of Pemetrexed in patients diagnosed with low risk Gestational Trophoblastic Tumor (GTT) that have failed prior treatment.", - "NCTID": "NCT00190918" - }, - { - "brief_title": "Laparoscopic Occlusion of Uterine Vessels Compared to Uterine Fibroid Embolization for Treatment of Uterine Fibroids", - "phase": "", - "drugs": "['Laparoscopic bilateral occlusion of uterine artery', 'Radiological embolization (UFE)']", - "drugs_list": [ - "Laparoscopic bilateral occlusion of uterine artery", - "Radiological embolization (UFE)" - ], - "diseases": "['Uterine Fibroids']", - "diseases_list": [ - "Uterine Fibroids" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Menorrhagia and/or bulk symptoms associated with uterine fibroids \n\n ", - "exclusion_criteria": ": \n\n Malignancy \n\n Current or planned pregnancy \n\n Small submucous fibroids suitable for hysteroscopic resection \n\n Postmenopausal women \n\n Suspected or known adenomyosis \n\n Uterus size exceeding the umbilical level \n\n Contraindications against laparoscopic surgery", - "brief_summary": "Women with symptomatic uterine fibroids are treated either by Uterine Fibroid Embolization (UFE) or laparoscopic occlusion. The study hypothesis is that laparoscopic occlusion of uterine vessels and UFE have equal effect on bleeding symptoms. Menstrual bleeding reduction six months after treatment is the main endpoint. Secondary endpoints include participants assessment of symptom relief, and volume reduction of fibroids measured by MRI. We will also investigate possible differences in postoperative course, symptom reduction, complication, and recurrence. Patients are controlled with regular intervals up to five years after treatment.", - "NCTID": "NCT00277680" - } - ] - }, - { - "patient_id": "sigir-201416", - "patient": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", - "0": [ - { - "brief_title": "A Phase 3 Clinical Trial for a Rabies Vaccine (Vero Cell) for Human Use in Healthy Chinese Subjects", - "phase": "Phase 3", - "drugs": "['Changchun Werersai', 'Jilin Maifeng']", - "drugs_list": [ - "Changchun Werersai", - "Jilin Maifeng" - ], - "diseases": "['Rabies']", - "diseases_list": [ - "Rabies" - ], - "enrollment": "1200.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged from 10 to 60 years old \n\n Subjects or legal guardians can and will comply with the requirements of the protocol \n\n Subjects or legal guardians are able to understand and sign the informed consent \n\n Healthy subjects judged from medical history after investigator's inquiry \n\n Subjects with temperature <=37.0\u00b0C on axillary setting \n\n ", - "exclusion_criteria": ": \n\n Female in lactation or pregnancy, or plan to be pregnant during the study period \n\n Subject who has allergic history to any vaccine or other medicines \n\n Subject who has injury history by dogs or other mammals and has been vaccinated with rabies vaccine \n\n Subject who has serious adverse reaction history after vaccination such as allergies, hives, difficulty in breathing, angioedema or abdominal pain \n\n Subject with congenital malformation, developmental disorder or serious chronic disease \n\n Subject with autoimmune diseases or immunodeficiency \n\n Subject with asthma, unstable over the past two years requiring emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids \n\n Subject with diabetes (Type I or II) excluding gestational diabetes \n\n Subject with thyroidectomy history, or require treatment in the past 12 months due to thyroid disease \n\n Subject with severe angioedema in the past 3 years or require treatment in the past 2 years \n\n Subject with hypertension and with a blood pressure exceeding 145/95 mmHg at enrollment time \n\n Subject with coagulation abnormalities diagnosed by doctors (such as clotting factor deficiency, coagulation disorders, platelet disorder) or obvious bruises or blood clotting disorder \n\n Subject with cancer, or has been treated in active cancer period or not clearly cured, or may recur during the study period \n\n Subject with epilepsy, excluding those alcohol epilepsy within three years before quitting drinking or those do not need treatment in the past 3 years \n\n Asplenia, functional asplenia, without a spleen or removal of the spleen caused by any situation \n\n Guillain-Barre syndrome \n\n Any prior administration of immunodepressant or corticosteroids in last 6 months \n\n Any prior administration of blood products in last 3 months \n\n Any prior administration of other research medicine/vaccine in last 30 days \n\n Any prior administration of any attenuated live vaccine in last 30 days \n\n Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine \n\n Ongoing anti-tuberculosis prevention or treatment \n\n Subject who cannot comply with the trial requirements, or with mental illness/ dual-stage affective psychosis in the past or at present; or has not been controlled and needs to take psychiatric drugs the past 2 years; or with suicidal tendencies in the past 5 years \n\n Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent", - "brief_summary": "The purpose of this single-centre, randomized, double-blind, parallel control, phase 3 study is to evaluate the safety and immunogenicity of a rabies vaccine (Vero Cell) for human use in healthy Chinese subjects aged 10-60 years, according to the Essen methods (1-1-1-1-1) vaccination.", - "NCTID": "NCT02491541" - }, - { - "brief_title": "A Randomized Phase II Trial to Compare the Safety and Neutralizing Activity of CL184 in Combination With Rabies Vaccine vs. HRIG or Placebo in Combination With Rabies Vaccine in Healthy Adult Subjects", - "phase": "Phase 2", - "drugs": "['CL184', 'HRIG', 'Placebo matching CL184']", - "drugs_list": [ - "CL184", - "HRIG", - "Placebo matching CL184" - ], - "diseases": "['Rabies']", - "diseases_list": [ - "Rabies" - ], - "enrollment": "140.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects free of obvious health-problems or with stable condition \n\n Male or female subjects aged \u226519 to \u226465 years \n\n BMI between \u226518 and \u226430 kg/m2 \n\n ", - "exclusion_criteria": ": \n\n Prior history of active or passive rabies immunization \n\n Clinically significant acute illness or infection within 2 weeks before first dosing based on the clinical judgment of the investigator \n\n History and/or family history of clinically significant immunodeficiency or auto-immune disease \n\n Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction \n\n Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product", - "brief_summary": "The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in combination with rabies vaccine compared with human rabies immune globulin (HRIG) or placebo in combination with rabies vaccine in healthy adult subjects.", - "NCTID": "NCT00656097" - }, - { - "brief_title": "Rabies Virus Neutralizing Activity and Safety of CL184, a Monoclonal Antibody Cocktail, in Simulated Rabies Post-Exposure Prophylaxis in Healthy Adults", - "phase": "Phase 2", - "drugs": "['Rabies virus-specific monoclonal antibodies', 'human polyclonal rabies immune globulin (HRIG)', 'Placebo', 'Human diploid cell vaccine (HDCV)', 'Purified verocell rabies vaccine (PVRV)']", - "drugs_list": [ - "Rabies virus-specific monoclonal antibodies", - "human polyclonal rabies immune globulin (HRIG)", - "Placebo", - "Human diploid cell vaccine (HDCV)", - "Purified verocell rabies vaccine (PVRV)" - ], - "diseases": "['Rabies']", - "diseases_list": [ - "Rabies" - ], - "enrollment": "240.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female subject aged \u226518 to \u226455 years \n\n Subjects free of obvious health-problems or with stable conditions or medications \n\n Body mass index between \u226518 to \u226430 kg/m2 \n\n Abstinence from sexual intercourse or use of adequate contraception from the date of screening up to Day 90 \n\n Male subjects must agree that they will not donate sperm from the first check-in until Day 90 \n\n Subject signed written informed consent \n\n ", - "exclusion_criteria": ": \n\n Prior history of active or passive rabies immunization \n\n Clinically significant acute illness or infection including fever (\u226538 \u00b0C) within 2 weeks before first dosing \n\n History and/or family history of clinically significant immunodeficiency or auto-immune disease \n\n Planned immunization with live vaccines during the coming 3 months after first dosing \n\n Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product", - "brief_summary": "Study design:~Single-blind (subject and observer-blinded), active-controlled, randomized [6:2:1:2:1; CL184 + purified vero cell rabies vaccine (PVRV) vs. human rabies immune globulin (HRIG) + PVRV vs. placebo + PVRV vs. CL184 + human diploid cell vaccine (HDCV) vs. placebo + HDCV], mono-center study~Study objectives:~Primary: To evaluate the safety of CL184 in combination with PVRV in healthy adult subjects.~Secondary: To evaluate the safety of HRIG or placebo in combination with PVRV and to evaluate the safety of CL184 or placebo in combination with HDCV in healthy adult subjects. To evaluate the rabies virus neutralizing activity (RVNA) after administration of CL184 or placebo in combination with PVRV, of HRIG in combination with PVRV, and of CL184 or placebo in combination with HDCV in healthy adult subjects. To evaluate the pharmacokinetics of the monoclonal antibodies (mAbs).", - "NCTID": "NCT01228383" - }, - { - "brief_title": "Safety and Immunogenicity of Two Intradermal Rabies Vaccine Regimens Administered With and Without Human Rabies Immunoglobulin in Subjects \u2265 1 Years of Age", - "phase": "Phase 3", - "drugs": "['Rabies vaccine', 'Rabies vaccines + Rabies immunoglobulins', 'Rabies vaccine', 'Rabies vaccines + Rabies immunoglobulins']", - "drugs_list": [ - "Rabies vaccine", - "Rabies vaccines + Rabies immunoglobulins", - "Rabies vaccine", - "Rabies vaccines + Rabies immunoglobulins" - ], - "diseases": "['Rabies Infection']", - "diseases_list": [ - "Rabies Infection" - ], - "enrollment": "885.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy males and females \u2265 1 years of age \n\n Individuals/ individual's parents or legal guardians who have given written consent \n\n Individuals in good health \n\n Individuals who can comply with study procedures \n\n ", - "exclusion_criteria": ": \n\n Behavioral or cognitive impairment or psychiatric disease. \n\n Unable to comprehend and to follow all required study procedures for the whole period of the study. \n\n History of illness or with an ongoing illness that may pose additional risk to the individual if he/she participates in the study. \n\n Individuals \u2265 1 to \u2264 17 years of age, who have or ever had a malignancy. \n\n Individuals \u2265 18 years of age, who have or who within the last 5 years, have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder. \n\n Known or suspected impairment of the immune system (including but not limited to HIV, autoimmune disorders, immunosuppressive therapy as applicable). \n\n Female of childbearing potential who has not used any of the acceptable contraceptive methods for at least 2 months prior to study entry. \n\n Female of childbearing potential, refusal to use an acceptable birth control method through day 50. \n\n Female of childbearing potential, with a positive pregnancy test prior to enrollment. \n\n Received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the previous 12 weeks. \n\n Allergic to any of the vaccine components. \n\n Allergic to any of the human rabies immunoglobulin components. \n\n Contraindication or precaution against rabies vaccination. \n\n Contraindication or precaution against man rabies immunoglobulin administration. \n\n Planning to receive anti-malaria medications (e.g. Mefloquine) 14 days prior to day 1 vaccination through day 50. \n\n Participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study. \n\n Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 28 days from the study vaccines. \n\n Body temperature \u2265 38.0\u00b0C (\u2265 100.4\u00b0F) within 3 days of intended study vaccination. \n\n Received rabies vaccines or rabies immunoglobulin or have been exposed to rabies. \n\n Part of the study personnel or immediate family members of study personnel conducting this study. \n\n Current or history of drug or alcohol abuse within the past 2 years.", - "brief_summary": "Demonstrate non-inferiority of the immune response between new versus the currently recommended intradermal regimens of rabies vaccine when administered with or without rabies immunoglobulins in healthy subjects \u2265 1 years of age.", - "NCTID": "NCT02177032" - }, - { - "brief_title": "The Protection Effect of Speeda\u00ae Rabies Vaccine for Human Use", - "phase": "Phase 4", - "drugs": "['rabies vaccine']", - "drugs_list": [ - "rabies vaccine" - ], - "diseases": "['Rabies Vaccine Allergy']", - "diseases_list": [ - "Rabies Vaccine Allergy" - ], - "enrollment": "37.0", - "inclusion_criteria": "inclusion criteria: \n\n Parent/legal acceptable representatives of children or the adult participants are willing and able to understand the protocol requirements and provide informed consent signed \n\n Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local \u2265 12 months before injured \n\n The man-killer could found and detect whether it carries the virus \n\n ", - "exclusion_criteria": ": \n\n Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth \n\n Apply passive immunity preparation", - "brief_summary": "The objective of this study was to achieve the post-marketing protective effect research of Speeda\u00ae rabies vaccine for human use from Chengda Bio.", - "NCTID": "NCT01827917" - }, - { - "brief_title": "Observation Study an Immunogenicity Modified TRC-ID Regimen With CPRV With or Without Rabies Immunoglobulin in Children", - "phase": "", - "drugs": "['rabies vaccine']", - "drugs_list": [ - "rabies vaccine" - ], - "diseases": "['Dog Bite']", - "diseases_list": [ - "Dog Bite" - ], - "enrollment": "45.0", - "inclusion_criteria": "inclusion criteria: \n\n they are 1-15 years healthy children \n\n give signed informed consent from their parents \n\n willing to participate in this study and be able to receive the vaccination and collect blood sample as the study plan. \n\n ", - "exclusion_criteria": ": \n\n they have prior history of rabies vaccination or any equine/human serum administration such as snake antivenom and tetanus antiserum or vaccine allergy \n\n Persons who have immunosuppressive conditions such as known HIV infection, transplantation, chronic renal failure, receiving of steroid or immunosuppressive drugs \n\n person received anti-malarial drugs within the previous two months or any blood products within previous three months were excluded \n\n Urine pregnancy test must be done in all female adolescents to exclude the pregnancy in first visit", - "brief_summary": "To determine Immunogenicity and Safety Study of Modified TRC-ID Regimen with A New Chromatographically Purified Vero Cell Rabies Vaccine (SPEEDA\u00ae) as post exposure rabies intradermal regimen with or without Rabies Immunoglobulin in Children", - "NCTID": "NCT02339896" - }, - { - "brief_title": "Effect of Antimalarial Drugs to Rabies Vaccine for Post-exposure Prophylaxis.", - "phase": "Phase 4", - "drugs": "['Chloroquine', 'Atovaquone and Proguanil', 'Doxycycline', 'Rabies Vaccine']", - "drugs_list": [ - "Chloroquine", - "Atovaquone and Proguanil", - "Doxycycline", - "Rabies Vaccine" - ], - "diseases": "['Rabies']", - "diseases_list": [ - "Rabies" - ], - "enrollment": "103.0", - "inclusion_criteria": "inclusion criteria: \n\n Provide signed and dated informed consent form. \n\n Willing to comply with all study procedures and be available for the duration of the study. \n\n Male or female, aged \u2265 18 to \u2264 60 years on day of inclusion. \n\n In good general health based on medical history and physical exam \n\n ", - "exclusion_criteria": ": \n\n Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination. \n\n Participation in the 4 weeks preceding the first trial vaccination, or planned participation during the present trial period, in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. \n\n Previous history of receiving the rabies vaccine. \n\n Previous history of receiving rabies immune globulin. \n\n Any major psychiatric disorder, such as severe depression, severe anxiety disorder, psychosis, schizophrenia, other major psychiatric disorders, or seizures. History of mild depression or anxiety disorder that are well controlled are not ", - "brief_summary": "This is an exploratory trial to evaluate the effect of antimalarial drugs on the immune response generated by rabies vaccine when administered for post-exposure prophylaxis. This study will use the FDA approved post-exposure prophylaxis vaccine regimen (without rabies immune globulin) in the presence or absence of an FDA-approved malaria chemoprophylaxis regimen.", - "NCTID": "NCT02564471" - }, - { - "brief_title": "Immune Response in Adults to PrEP and Simulated Booster PEP With a New CPRV", - "phase": "", - "drugs": "['New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).']", - "drugs_list": [ - "New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV)." - ], - "diseases": "['Efficacy of the New CPRV']", - "diseases_list": [ - "Efficacy of the New CPRV" - ], - "enrollment": "105.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy \n\n Can visit according to the protocol \n\n ", - "exclusion_criteria": ": \n\n Fever \n\n Acute illness \n\n History of rabies vaccination \n\n Allergic to the vaccines' component \n\n Immunosuppressive conditions such as HIV infection, transplantation, chronic renal failure, received steroid or immunosuppressive drugs and anti-malarial drugs within previous two months or any blood products within previous three months \n\n Female participant must not be pregnant \n\n All female participant must have urine pregnancy test negative prior to participate the study", - "brief_summary": "Pre exposure rabies vaccination with a new Chromatographically Purified Vero-cell Rabies Vaccine(SPEEDA) is as effective as Purified Vero-cell Rabies vaccine.~After the pre exposure rabies vaccination with a new Chromatographically Purified Vero-cell Rabies Vaccine(SPEEDA), the Rabies neutralizing antibodies in all patients on day 42 are 0.5 IU/ml or more.~And Simulated post-exposure rabies booster vaccination with a new Chromatographically Purified Vero-cell Rabies Vaccine(SPEEDA) is as effective as Purified Vero-cell Rabies vaccine.~After the simulated post-exposure rabies booster vaccination with a new Chromatographically Purified Vero-cell Rabies Vaccine(SPEEDA), the Rabies neutralizing antibodies in all patients on day 14 after the booster are 0.5 IU/ml or more.", - "NCTID": "NCT01603875" - }, - { - "brief_title": "Purified Vero Rabies Vaccine-Serum Free Compared to Human Diploid Cell Vaccine in a Pre-exposure Prophylaxis Regimen", - "phase": "Phase 2", - "drugs": "['Purified Vero Rabies Vaccine Serum Free (VRVg)', 'Imovax\u00ae Rabies: Human Diploid Cell Vaccine (HDCV),']", - "drugs_list": [ - "Purified Vero Rabies Vaccine Serum Free (VRVg)", - "Imovax\u00ae Rabies: Human Diploid Cell Vaccine (HDCV)," - ], - "diseases": "['Rabies']", - "diseases_list": [ - "Rabies" - ], - "enrollment": "342.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged 2 to 17 years on the day of inclusion \n\n Informed consent form has been signed and dated by the parent(s) (and subject, if applicable by local regulations), or another legally acceptable representative and by an independent witness, as applicable, and the assent form has been signed and dated by the subject (if applicable by the local Ethics Committee or country regulations) \n\n Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures. \n\n ", - "exclusion_criteria": ": \n\n Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination) \n\n Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure \n\n Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial vaccination \n\n Any previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccine or another vaccine \n\n Bite by a potentially rabid animal in the previous 6 months without post-exposure prophylaxis \n\n Receipt of immune globulins, blood or blood-derived products in the past 3 months \n\n Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) \n\n Self-reported seropositivity for Human Immunodeficiency Virus (HIV) \n\n Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances \n\n Self-reported thrombocytopenia, contraindicating intramuscular vaccination \n\n Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination \n\n Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily \n\n Current alcohol abuse or drug addiction \n\n Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion \n\n Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature \u2265 38.0\u00b0C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided \n\n Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study \n\n History of Guillain-Barr\u00e9 syndrome.", - "brief_summary": "The aim of the study is to document immunogenicity and safety of VRVg in a pre-exposure regimen in healthy children and adolescents aged 2 to 17 years.~Primary Objectives:~To demonstrate that VRVg is non-inferior to Imovax\u00ae Rabies in terms of proportion of subjects achieving a rabies virus neutralizing antibody (RVNA) titer \u2265 0.5 international units (IU)/mL at D42, i.e. 14 days after the last vaccination.~To describe if at least 99% of subjects achieve an RVNA titer \u2265 0.5 IU/mL at D42 with a lower bound of the 95% confidence interval (CI) of at least 97%, in the VRVg group.~Secondary Objectives:~To assess the clinical safety of each vaccine after each vaccine injection when administered in a pre-exposure schedule.~To describe the immune response induced by each vaccine 14 days after the last vaccination, i.e. at D42, and 6 months after the first vaccination~To describe the geometric mean titer ratio between the two vaccine groups at D42, i.e. 14 days after the last vaccination.", - "NCTID": "NCT01930357" - }, - { - "brief_title": "Immune Responses After a Four-site Intradermal Rabies Booster Vaccination in HIV-infected Adults", - "phase": "", - "drugs": "['rabies vaccine']", - "drugs_list": [ - "rabies vaccine" - ], - "diseases": "['Rabies']", - "diseases_list": [ - "Rabies" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n HIV infected patients \n\n Age 18 - 60 years \n\n Received primary rabies immunization \n\n ", - "exclusion_criteria": ": \n\n Have any active opportunistic infections \n\n Received blood or blood product within 3 months \n\n Allergy to vaccine or any vaccine components \n\n Received anti-malarial drugs", - "brief_summary": "A four-site intradermal rabies booster vaccination in HIV - infected patients who have ever received primary rabies vaccination could improve their immune response to this kind of vaccine.", - "NCTID": "NCT02547727" - }, - { - "brief_title": "Study of Purified Vero Rabies Vaccine Serum Free Compared With Reference Purified Vero Rabies Vaccine in Healthy Adults", - "phase": "Phase 2", - "drugs": "['Purified Vero Rabies Vaccine - Serum Free', 'Purified inactivated rabies vaccine']", - "drugs_list": [ - "Purified Vero Rabies Vaccine - Serum Free", - "Purified inactivated rabies vaccine" - ], - "diseases": "['Rabies']", - "diseases_list": [ - "Rabies" - ], - "enrollment": "384.0", - "inclusion_criteria": "inclusion criteria : \n\n Aged 18 to 60 years on the day of inclusion \n\n Provision of a signed Informed Consent Form \n\n Able to attend all scheduled visits and comply with all trial procedures \n\n For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence for at least 4 weeks prior to each vaccination, until at least 4 weeks after each vaccination) \n\n Entitlement to national social security \n\n ", - "exclusion_criteria": " : \n\n For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test \n\n Breast-feeding woman \n\n Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination \n\n Planned participation in another clinical trial during the present trial period \n\n Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy \n\n Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances \n\n Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator \n\n Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures \n\n Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response \n\n Receipt of any vaccine in the 4 weeks preceding the first trial vaccination \n\n Planned receipt of any vaccine in the 4 weeks following any trial vaccination \n\n Known human immunodeficiency virus (HIV), Hepatitis B surface (HBs) antigen, or Hepatitis C seropositivity \n\n Previous vaccination against rabies with any vaccine (in pre- or post-exposure regimen) \n\n Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination \n\n Subject at high risk for rabies exposure during the trial period \n\n Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent \n\n Febrile illness (temperature \u226538.0\u00b0C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment. \n\n Study site employee who is involved in the protocol and may have direct access to trial related data.", - "brief_summary": "The purpose of this study is to generate data in human on immunogenicity and safety of Purified Vero Rabies Vaccine (VRVg) in support of the vaccine registration.~Primary Objective:~To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab, in terms of seroconversion rate at Day 42 of the primary vaccination series.~Secondary Objectives:~To assess the clinical safety of VRVg after each vaccination when administered in a pre-exposure vaccination schedule with a booster at 12 months after the first vaccination in all subjects.~To describe the immune response induced by VRVg 21 days after two vaccinations in a subset of randomized subjects and 14 days after the last vaccination of the primary vaccination series.", - "NCTID": "NCT00948272" - }, - { - "brief_title": "Study of Intradermal Administration of PCEC Rabies Vaccine", - "phase": "", - "drugs": "['PCEC rabies vaccine given intradermally', 'PCEC rabies vaccine administered intramuscularly']", - "drugs_list": [ - "PCEC rabies vaccine given intradermally", - "PCEC rabies vaccine administered intramuscularly" - ], - "diseases": "['Rabies Prevention', 'Rabies Exposure']", - "diseases_list": [ - "Rabies Prevention", - "Rabies Exposure" - ], - "enrollment": "130.0", - "inclusion_criteria": "inclusion criteria: \n\n Laboratory personnel, epidemiologists, EISOs, veterinary students, interns, and other first responders at CDC; other CDC employees; and healthy volunteer adults. Persons who contact the study coordinator will be assessed for possible occupational exposure to rabies using the risk assessment form (appendix E). The volunteers reporting occupational exposure will be selected to enter the study. \n\n Male or nonpregnant females (as indicated by a negative urine pregnancy test prior to first dose of vaccine), aged 18 years and older. \n\n Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, or licensed hormonal methods) for the entire study period. \n\n Be in good health, as determined by vital signs (pulse, blood pressure, oral temperature), medical history, and a targeted physical examination based on medical history. \n\n Able to understand and comply with planned study procedures. \n\n Provide informed consent prior to any study procedures and be available for all study visits. \n\n Have health insurance. \n\n ", - "exclusion_criteria": ": \n\n Have a known allergy to PCECV. \n\n Have a known allergy or sensitivity to eggs or latex (in the stopper). \n\n Have a positive urine pregnancy test prior to first vaccine dose (female of childbearing potential age). \n\n Are immunosuppressed as a result of an underlying illness or treatment. \n\n Have active neoplastic disease or a history of any hematologic malignancy. \n\n Are using oral or parenteral steroids, high-dose inhaled steroids (>800 \u03bcg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs. \n\n Have a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study. \n\n Have an acute illness that is accompanied by an oral temperature greater than 100.4\u00b0F, within 1 week of vaccination. \n\n Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during the 1st month of the study period. \n\n Have any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. \n\n He/she is a CDC worker under direct supervision of any of the primary study investigators (Dr. Sergio Recuenco, and Dr. Eli Warnock).", - "brief_summary": "The purpose of this study is to determine immunogenicity and safety of intradermal administration of the PCEC rabies vaccine in adults.", - "NCTID": "NCT01044199" - }, - { - "brief_title": "Rabies Immunization Concomitant With JEV in Children", - "phase": "Phase 2", - "drugs": "['Rabies vaccine']", - "drugs_list": [ - "Rabies vaccine" - ], - "diseases": "['Rabies']", - "diseases_list": [ - "Rabies" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female 12-18 months old toddlers will be included in the study if they; \n\n are in good health at time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator; \n\n are available for all the visits scheduled in the study; \n\n have been granted a written informed consent signed by their parents \n\n ", - "exclusion_criteria": ": \n\n a history of rabies immunization; \n\n a history of Japanese encephalitis immunization or disease; \n\n a significant acute or chronic infectious disease at the time of enrollment; \n\n fever > 38.0 degree C (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment; \n\n being under treatment with parenteral, oral and/or inhaled corticosteroids, immunosuppressive drugs or other specific anti-inflammatory drugs or having taken chloroquine during the two months period before enrollment; \n\n administration of any vaccine within the past 14 days before enrollment; \n\n known immunodeficiency or an autoimmune disease; \n\n known hypersensitivity to neomycin, tetracycline, amphotericin-B; \n\n planned surgery during the study period; \n\n being enrolled in any other investigational trial contemporaneously; \n\n the family plans to leave the area of the study site before the end of study period; \n\n history of febrile convulsions; \n\n history of wheezing", - "brief_summary": "Background. The World Health Organization recommends pre-exposure vaccination (PreP) to protect children living in canine rabies endemic countries. Including PreP in national childhood immunization programs (EPI) is a viable option.~Methods. In an open-label phase II clinical trial, 200 healthy toddlers were randomized to receive Purified Chick Embryo Cell Vaccine (PCECV) in a 3-dose Full-IM (1mL), Half-IM (0.5mL), 3-ID (0.1mL), or a 2-dose 2-ID (0.1mL) regimen, all in combination with two doses of Japanese Encephalitis (JEV), or JEV alone. One booster dose of PCECV (IM or ID) and JEV, or JEV alone was administered concomitantly one year after primary vaccination. Safety was evaluated after each injection. Blood was drawn on days 0 and 49, one year later prior to booster and on days 7 and 28 post-booster, and at two and three years post primary vaccination. All sera were analyzed for rabies and JE virus neutralizing antibodies (RVNA, JEVNA).", - "NCTID": "NCT00703521" - }, - { - "brief_title": "A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults", - "phase": "Phase 3", - "drugs": "['Typhoid Vi Polysaccharide Vaccine', 'Yellow Fever Vaccine', 'Japanese Encephalitis Vaccine', 'Rabies Vaccine', 'MenACWY-CRM Vaccine']", - "drugs_list": [ - "Typhoid Vi Polysaccharide Vaccine", - "Yellow Fever Vaccine", - "Japanese Encephalitis Vaccine", - "Rabies Vaccine", - "MenACWY-CRM Vaccine" - ], - "diseases": "['Meningococcal Disease', 'Meningococcal Meningitis', 'Typhoid', 'Yellow Fever', 'Rabies', 'Japanese Encephalitis']", - "diseases_list": [ - "Meningococcal Disease", - "Meningococcal Meningitis", - "Typhoid", - "Yellow Fever", - "Rabies", - "Japanese Encephalitis" - ], - "enrollment": "552.0", - "inclusion_criteria": "inclusion criteria: \n\n Female and male subjects who must be healthy and must be: \n\n Between 18 and 60 years of age inclusive and who have given their written informed consent; \n\n Available for all visits and telephone calls scheduled for the study; \n\n In good health as determined by medical history, physical examination and clinical judgment of the investigator; \n\n For female subjects, having a negative urine pregnancy test. \n\n ", - "exclusion_criteria": ": \n\n Individuals not eligible to be enrolled in the study are those: \n\n who are breastfeeding; \n\n who have a personal history of Neisseria meningitidis infection, typhoid fever, rabies, or any flavivirus infection (e.g., Japanese encephalitis, tick-borne encephalitis, yellow fever, dengue fever, West Nile virus infection); \n\n who have been immunized with any of the study vaccines within the last five years as determined by medical history and/or vaccination card; \n\n who have received investigational agents or vaccines within 30 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to completion of the study; \n\n who have received live licensed vaccines within 30 days and inactive vaccine within 15 days prior to enrollment or for whom receipt of a licensed vaccine is anticipated during the study period. \n\n (Exception: Influenza vaccine may be administered up to 15 days prior to each study immunization and no less than 15 days after each study immunization); \n\n who have received an anti-malaria drug, up to 2 months prior to the study; \n\n who have experienced, within the 7 days prior to enrollment, significant acute infection (for example requiring systemic antibiotic treatment or antiviral therapy) or have experienced fever (defined as body temperature \u2265 38\u00b0C) within 3 days prior to enrollment; \n\n who have any serious acute, chronic or progressive disease such as: \n\n history of cancer \n\n complicated diabetes mellitus \n\n advanced arteriosclerotic disease \n\n autoimmune disease \n\n HIV infection or AIDS \n\n blood dyscrasias \n\n congestive heart failure \n\n renal failure \n\n severe malnutrition (Note: Subjects with mild asthma are eligible for enrollment. Subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids are not eligible for enrollment); \n\n who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome; \n\n who have a history of anaphylaxis, serious vaccine reactions, or allergy to any vaccine component, including but not limited to latex allergy, egg allergy, antibiotic allergy, chicken proteins or gelatin allergy; \n\n who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example): \n\n receipt of immunosuppressive therapy within 30 days prior to enrollment (systemic corticosteroids administered for more than 5 days, or in a daily dose > 1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy); \n\n receipt of immunostimulants; \n\n receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study; \n\n who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time; \n\n who have myasthenia gravis; thyroid or thymic disorders, \n\n who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives; \n\n who are part of the study personnel or close family members of those conducting this study. \n\n for whom a long-term stay (\u2265 1 month) was planned in Africa, Latin America, or Asia.", - "brief_summary": "This study compares the safety and immunogenicity profile of several travel vaccines given alone or concomitantly with MenACWY-CRM to healthy adults.", - "NCTID": "NCT01466387" - }, - { - "brief_title": "Malaria Vaccine for Children in Mali", - "phase": "Phase 1", - "drugs": "['AMA1-C1/Alhydrogel plus CPG 7909']", - "drugs_list": [ - "AMA1-C1/Alhydrogel plus CPG 7909" - ], - "diseases": "['Malaria', 'Malaria Infection']", - "diseases_list": [ - "Malaria", - "Malaria Infection" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Males or females aged greater than or equal to 1 to less than 4 years \n\n Known residents of the village of Bancoumana, Mali or its surrounding area \n\n Good general health as determined by means of the screening procedure \n\n Available for the duration of the trial (24 months from enrollment) \n\n Willingness to have child participate in the study as evidenced by parents/legal guardians signing or fingerprinting the informed consent document \n\n ", - "exclusion_criteria": ": \n\n Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, chronic infectious or renal disease by history, physical examination, and/or laboratory studies including urinalysis. \n\n Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the volunteer or the parent/legal guardian to understand and cooperate with the study protocol. \n\n Pre-existing known autoimmune diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia. \n\n Laboratory evidence of possible autoimmune disease determined by anti-dsDNA titer that equals or exceeds 25 IU. \n\n Laboratory evidence of liver disease (alanine aminotransferase [ALT] greater than the upper limit of normal of the testing laboratory). \n\n Laboratory evidence of renal disease (serum creatinine greater than the upper limit of normal of the testing laboratory, or more than trace protein or blood on urine dipstick testing confirmed by repeat testing). \n\n Laboratory evidence of hematologic disease (absolute leukocyte count less than 3000/mm(3) or greater than 14,500/mm(3), absolute lymphocyte count less than 1000/mm(3), platelet count less than 120,000/mm(3), or hemoglobin less than 8.5 g/dL). \n\n Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol. \n\n Participation in another investigational vaccine or drug trial within 30 days of starting this study, or while this study is ongoing. \n\n History of a severe allergic reaction or anaphylaxis. \n\n History of allergy to nickel. \n\n Severe asthma. This will be defined as: \n\n Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or parenteral corticosteroids. \n\n Clinically significant reactive airway disease that does not respond to bronchodilators. \n\n Positive screening test for anti-Hepatitis C virus (anti-HCV). \n\n Positive screening test for Hepatitis B surface antigen (HBsAg). \n\n Known immunodeficiency syndrome. \n\n Use of systemic corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study. \n\n History of a surgical splenectomy. \n\n Receipt of blood products within the past 6 months. \n\n Previous receipt of an investigational malaria vaccine or of rabies vaccine. \n\n History of use of chloroquine or related compounds (amodiaquine or primaquine) within 8 weeks of study entry. Chloroquine and related compounds have the potential to interfere with CPG-induced activation of B cells and plasma dendritic cells. \n\n Previous administration of Verorab Trademark vaccine. \n\n Known thrombocytopenia or bleeding disorders. \n\n Known allergy to neomycin (a component of Verorab Trademark).", - "brief_summary": "This study will evaluate the safety and immune response of children to an experimental malaria vaccine called AMA1-C1/Alhydrogel\u00ae (Registered Trademark) + CPG 7909. Malaria is an infection of red blood cells caused by a parasite, Plasmodium falciparum, that is spread by certain kinds of mosquitoes. It affects at least 300 million people worldwide each year, with more than 1 million deaths, mostly among children less than 5 years of age in sub-Saharan Africa. Malaria is the leading cause of death and illness among the general population of Mali in West Africa. Increasing drug resistance to P. falciparum and widespread resistance of mosquitoes to pesticides are reducing the ability to control the disease through these strategies. AMA1 C1 is made from a synthetic protein similar to a P. falciparum protein. It is combined with Alhydrogel and CPG 7909, substances added to vaccines to make them work better.~Children between 1 and 4 years of age who live in Bancoumana, Mali, and are in general good health may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests.~Participants are randomly assigned to receive three injections (shots) of either AMA1-C1 or a control rabies inactivated vaccine called Imovax\u00ae (Registered Trademark). The shots are given in the thigh muscle on study days 0, 56 and 180. After each shot, participants are observed in the clinic for 30 minutes. They return to the clinic for a physical examination six or seven times between each shot and then four more times over a 9-month period after the last shot. Blood samples are drawn at several of these visits to check for side effects of the vaccine and to measure the response to it. The total duration of the study is 21 months.~...", - "NCTID": "NCT00740090" - }, - { - "brief_title": "RNActive\u00ae Rabies Vaccine (CV7201) in Healthy Adults", - "phase": "Phase 1", - "drugs": "['CV7201 mRNA']", - "drugs_list": [ - "CV7201 mRNA" - ], - "diseases": "['Rabies']", - "diseases_list": [ - "Rabies" - ], - "enrollment": "101.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy male and female volunteers aged 18 to 40 years inclusive \n\n Compliant with protocol procedures and available for clinical follow-up through the last planned visit (V9) \n\n Physical examination and laboratory results without clinically significant findings \n\n Body Mass Index (BMI) \u2265 18.0 and \u2264 32.0 kg/m2 \n\n Females: Negative human chorionic gonadotropin (HCG) pregnancy test (serum) for women presumed to be of reproductive potential on the day of enrolment \n\n Females of childbearing potential must use acceptable methods of birth control during the trial and Follow-up period (from 6 weeks before the first administration of the test vaccine for the duration of the trial i.e., until the last planned visit (V9)). The following methods of birth control are acceptable when used consistently and correctly: established use of oral, injected or implanted hormonal methods of contraception; intrauterine devices (IUDs) or intrauterine systems (IUSs) with the exception of steel or copper wire; barrier methods of contraception (condom or occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository); true abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal and postovulation methods] and withdrawal are not acceptable). \n\n Males must use reliable forms of contraception (barrier method with spermicidal agent or true abstinence) and must refrain from sperm donation during the trial and Follow-up period i.e., until the last planned visit (V9). \n\n ", - "exclusion_criteria": ": \n\n Use of any investigational or non-registered product (drug or vaccine) other than the trial vaccine within 4 weeks preceding the administration of the trial vaccine, or planned use during the trial period \n\n Subject has received any other licensed vaccines within 4 weeks prior to the administration of the trial vaccine \n\n Subject has received any investigational or licensed rabies vaccine previously \n\n Intending to travel to regions/countries for which rabies vaccinations are recommended or where high risk of infections exists according to travel recommendations by the German Society of Tropical Medicine and International Health (DTG) during the trial and up to V9 (Day 91/120) Follow-up \n\n Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the trial vaccine. The use of inhaled and nasal steroids, as well as topical steroids outside the vaccination area, will be permitted \n\n Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination \n\n History of autoimmune disease \n\n Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of the trial vaccine \n\n Subject is taking chloroquine for malaria treatment or prophylaxis \n\n Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness or fever \u2265 38 \u00b0C measured orally \n\n Presence or evidence of significant acute or chronic, uncontrolled medical or psychiatric illness (subjects with uncomplicated chronic diagnoses stable and treated for \u2265 3 months e.g., mild hypertension well-controlled with medication, may be enrolled - provided the condition and its therapy are known not to be associated with an immunocompromised state or an autoimmune disease \n\n Major congenital defects \n\n Known allergy to any component of the trial product i.e., protamine. This includes subjects with allergy to fish protein, diabetics with allergy to protamine-containing insulin, or post-vasectomy males \n\n Known type I allergy to beta lactam antibiotics \n\n Evidence of current alcohol or drug abuse \n\n History of any neurological disorders or seizures, with the exception of febrile seizures during childhood \n\n Seropositivity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) (except in subjects previously vaccinated against HBV) or hepatitis C virus (HCV) \n\n Foreseeable non-compliance with protocol as judged by the Investigator \n\n For females: Pregnancy or lactation \n\n History of any life-threatening anaphylactic reactions. \n\n Subjects with impaired coagulation in whom an IM injection is contraindicated.", - "brief_summary": "The purpose of this trial is to assess the safety and immunogenicity of an investigational RNActive\u00ae rabies vaccine (CV7201) in healthy adults.", - "NCTID": "NCT02241135" - }, - { - "brief_title": "Immediate Effects Cervicothoracic Manipulation Versus Passive Upper Trapezius Stretch", - "phase": "", - "drugs": "['Upper Trapezius Stretch', 'Cervicothoracic manipulation', 'No intervention']", - "drugs_list": [ - "Upper Trapezius Stretch", - "Cervicothoracic manipulation", - "No intervention" - ], - "diseases": "['Neck Pain']", - "diseases_list": [ - "Neck Pain" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria: \n\n 1. No current history or past history of neck pain; able to lie on back or stomach without difficulty \n\n ", - "exclusion_criteria": ": \n\n 'Red flag' items indicated in your Neck Medical Screening Questionnaire such as history of a tumor, bone fracture, metabolic diseases, Rheumatoid Arthritis, osteoporosis, severe atherosclerosis, prolonged history of steroid use, etc. \n\n History of neck whiplash injury \n\n Diagnosis from your physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) down both arms \n\n Presence of central nervous system involvement such as exaggerated reflexes, changes in sensation in the hands, muscle wasting in the hands, impaired sensation of the face, altered taste, and presence of abnormal reflexes \n\n Evidence of neurological signs consistent with nerve root entrapment (pinched nerve in the neck) \n\n Prior surgery to your neck or upper back \n\n A medical condition which may influence assessment of pain or pressure pain thresholds (i.e. taking analgesics, sedatives, history of substance abuse, or cognitive deficiency) \n\n Diagnosis from your physician of fibromyalgia syndrome \n\n Currently pregnant, or could be pregnant", - "brief_summary": "The proposed project seeks to evaluate the influence of cervicothoracic (CT) manipulation and passive stretching to the upper trapezius on pressure pain thresholds and range of motion (ROM) in individuals without recent complain of neck pain.", - "NCTID": "NCT02552290" - }, - { - "brief_title": "Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke", - "phase": "", - "drugs": "['A-ROM Continuous Passive Rehabilitation', 'P-ROM Continuous Passive Rehabilitation']", - "drugs_list": [ - "A-ROM Continuous Passive Rehabilitation", - "P-ROM Continuous Passive Rehabilitation" - ], - "diseases": "['Stroke']", - "diseases_list": [ - "Stroke" - ], - "enrollment": "35.0", - "inclusion_criteria": "inclusion criteria: \n\n a history of acute phase of stroke (less than 12 months post onset), \n\n first stroke episode, \n\n no history of peripheral nerve injury or musculoskeletal disease in the affected upper extremity, \n\n no contracture of the affected wrist or fingers (Modified Ashworth<3), \n\n no history of any invasive procedure (Botulinum toxin type A) for the treatment of spasticity for at least 6 months before the start of this study, \n\n for P-ROM patients, the absence of active hand movements, \n\n for the A-ROM patients, the presence of active hand movements. \n\n ", - "exclusion_criteria": ": \n\n unstable medical disorders, \n\n active Complex Regional Pain Syndrome (CRPS), \n\n severe spatial neglect, \n\n aphasia, \n\n cognitive problems.", - "brief_summary": "The investigators evaluate the effectiveness of the application of continuous passive motion device for hand rehabilitation in two classes of patients: with a residual active motion and without a residual active motion.", - "NCTID": "NCT01936298" - }, - { - "brief_title": "ASIS for Botox in Upper Limb Spasticity", - "phase": "Phase 1; Phase 2", - "drugs": "['Gadolinium', 'Gadolinium', 'Gadolinium', 'Efficacy of Botox intramuscularly at Week 6', 'Efficacy of Botox intramuscularly at Week 12,', 'Efficacy of Botox intramuscularly at Week 18', 'Efficacy of Botox intramuscularly at Week 24', 'Efficacy of Botox intramuscularly at Week 30', 'Efficacy of Botox subdermally at Week 6', 'Efficacy of Botox subdermally at Week 12', 'Efficacy of Botox subdermally at Week 18', 'Efficacy of Botox subdermally at Week 24', 'Efficacy of Botox subdermally at Week 30', 'Adverse Reactions of Botox intramuscularly', 'Adverse Reactions of Botox subdermally']", - "drugs_list": [ - "Gadolinium", - "Gadolinium", - "Gadolinium", - "Efficacy of Botox intramuscularly at Week 6", - "Efficacy of Botox intramuscularly at Week 12,", - "Efficacy of Botox intramuscularly at Week 18", - "Efficacy of Botox intramuscularly at Week 24", - "Efficacy of Botox intramuscularly at Week 30", - "Efficacy of Botox subdermally at Week 6", - "Efficacy of Botox subdermally at Week 12", - "Efficacy of Botox subdermally at Week 18", - "Efficacy of Botox subdermally at Week 24", - "Efficacy of Botox subdermally at Week 30", - "Adverse Reactions of Botox intramuscularly", - "Adverse Reactions of Botox subdermally" - ], - "diseases": "['Upper Limb Spasticity Unilaterally in Adults With History of Stroke', 'Increased Muscle Tone in Elbow, Wrist, Finger, and Thumb Flexors.']", - "diseases_list": [ - "Upper Limb Spasticity Unilaterally in Adults With History of Stroke", - "Increased Muscle Tone in Elbow", - "Wrist", - "Finger", - "and Thumb Flexors." - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults with history of stroke that resulted in a unilateral, upper-limb focal spasticity \n\n Wrist flexor tone of more than 2 and finger flexor tone of more than 2 as measured by the Ashworth Scale \n\n Ability to understand and follow verbal directions \n\n At least 1 functional disability item (hygiene, dressing, pain, or limb posture) with a rating of more than 2 on the Disability Assessment Scale (DAS) \n\n At least 1 functional task score at Day 0 that met the following criteria: nail filing less than 6, hand cleaning less than 6, holding a water bottle less than 4, brushing teeth less than 4, holding fruit (small, medium, or large equals no. \n\n ", - "exclusion_criteria": ": \n\n Stroke within 6 months of the study enrollment visit \n\n Females who are pregnant, nursing, or planning a pregnancy during the study period or who are not using a reliable means of contraception \n\n Previous or current Botox therapy of any type in the study limb \n\n Any medical condition that may put the patient at increased risk with Botox exposure or any other disorder that might have interfered with neuromuscular function \n\n Presence of fixed contracture of the study limb \n\n Limited use of the wrist and fingers", - "brief_summary": "Botox act on nerve endings, yet there are no nerve endings inside the muscle, where they are typically injected. All nerves terminate on the fascia, where ASIS device can precisely deliver Botox by creating that subdermal bloodless space, between the skin and muscle. Thus enhancing and prolonging Botox's efficacy, at the same time prevent it's unnecessary adverse reactions and distant spread, especially since Botox has no reason to travel to the rest of the body any way.", - "NCTID": "NCT02074150" - }, - { - "brief_title": "Octanol to Treat Essential Tremor", - "phase": "Phase 2", - "drugs": "['1-Octanol']", - "drugs_list": [ - "1-Octanol" - ], - "diseases": "['Essential Tremor']", - "diseases_list": [ - "Essential Tremor" - ], - "enrollment": "14.0", - "inclusion_criteria": "inclusion criteria: \n\n 14 patients with a clinical diagnosis of essential tremor will participate in the study. Selection criterion is essential tremor with a history of ethanol responsiveness. Informed consent will be obtained by any of the co-investigators. \n\n Patients must be off any medications used to treat essential tremor such as mysoline or propranolol for at least 2 weeks. Patients must withhold ethanol and caffeine 24 hours prior to starting the treatment periods through the end of treatment periods, including alcohol or caffeine containing over the counter medications. Ethanol and caffeine consumption is allowed in the washout period. \n\n ", - "exclusion_criteria": ": \n\n Patients with abnormalities on neurologic exam other than tremor. \n\n Patients with a history of chronic alcohol dependence. \n\n Patients with chronic medical conditions such as renal failure, hepatic failure and chronic lung disease. \n\n Patients on other medications that cannot be temporarily discontinued for the length of the study. \n\n Patients, who, for moral or religious reasons, do not wish to take a potentially intoxicating drug. \n\n Patients with abnormalities on their baseline screening laboratory tests. \n\n Women who are pregnant or lactating. \n\n Patients under the age of 21. \n\n Asians and Pacific Islanders.", - "brief_summary": "This study will evaluate the effectiveness of 1-octanol, a substance similar to alcohol but less intoxicating, for treating essential tremor. Essential tremor is an involuntary shaking, usually of the hands, for which there is no satisfactory treatment. It affects about 1.4 percent of the general U.S. population, with the figure climbing to nearly 4 percent among people over 40. Results of two previous NIH studies have shown 1-octanol to be promising as a potential new treatment. This study will test the effectiveness of 1-octanol on essential tremor at doses lower than those given previously.~Patients 21 years old and older with essential tremor may be eligible for this study. Participants are admitted to the NIH Clinical Center for two treatment periods of 1 week each, with a 1-week break at home between treatments. Before beginning treatment, participants undergo a medical history, physical examination, blood and urine tests, and an electrocardiogram (EKG). In addition, tremors are measured using accelerometry, a procedure in which a small device, mounted on a piece of cardboard, is taped to the patient's hand for about 30 minutes.~Patients are randomly assigned to one of two groups. One group takes 2 to 4 capsules of 1-octanol 3 times a day for 1 week, followed by a 1-week washout period (no treatment), and then 2 to 4 capsules of placebo 3 times a day for 1 week. Following the same dosage schedule, the second group takes placebo the first week, followed by the washout period and then 1-octanol treatment. Blood pressure and pulse are measured at 15, 30, and 60 minutes after the first dose of the day and then 3 times a day each day of hospitalization, EKG and blood draws are done every other day during hospitalization, and blood is drawn again 1 week after the end of the study. Patients evaluate their tremor daily according to a tremor scale and are also rated according to an alcohol intoxication scale.", - "NCTID": "NCT00080366" - }, - { - "brief_title": "Robot Aided Rehabilitation - Intervention", - "phase": "", - "drugs": "['Passive stretching', 'Passive movement', 'IntelliArm', 'Hand robot']", - "drugs_list": [ - "Passive stretching", - "Passive movement", - "IntelliArm", - "Hand robot" - ], - "diseases": "['Stroke']", - "diseases_list": [ - "Stroke" - ], - "enrollment": "72.0", - "inclusion_criteria": "inclusion criteria: \n\n First focal unilateral lesion, ischemic or hemorrhagic \n\n Had a stroke 1-12 months prior to enrollment \n\n Rated between stages 2-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Arm and Hand \n\n ", - "exclusion_criteria": ": \n\n Apraxia \n\n Score of less than 22 on the Mini Mental Status Exam \n\n Severe pain in the shoulder by a self-rating of 7 out of 10 or greater \n\n Severe contracture in the upper extremity \n\n Unable to sit in a chair for 3 consecutive hours \n\n Unrelated musculoskeletal injuries \n\n Poor fit into equipment used in study \n\n Botox injection in upper extremity within 4 months \n\n Concurrent participation in gait or upper extremity intervention studies", - "brief_summary": "Sensorimotor impairments following stroke often involve complex pathological changes across multiple joints and multiple degrees of freedom of the arm and hand, thereby rendering them difficult to diagnose and treat. The objective of this study is to evaluate multi-joint neuromechanical impairments in the arm and hand, then conduct impairment-specific treatment, and determine the effects of arm versus hand training and the effects of passive stretching before active movement training.", - "NCTID": "NCT02359253" - }, - { - "brief_title": "Effectiveness of Radial Extracorporeal Shockwave Therapy on Tennis Elbow", - "phase": "", - "drugs": "['Radial extracorporeal shock wave therapy (rESWT)', 'sham shockwave therapy', 'Physical therapy']", - "drugs_list": [ - "Radial extracorporeal shock wave therapy (rESWT)", - "sham shockwave therapy", - "Physical therapy" - ], - "diseases": "['Lateral Epicondylosis', 'Lateral Epicondylitis', 'Tennis Elbow']", - "diseases_list": [ - "Lateral Epicondylosis", - "Lateral Epicondylitis", - "Tennis Elbow" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged > 18 years old \n\n Lateral elbow pain lasting > 3 months \n\n Pain induced by direct compression on the lateral epicondyle or common extensor tendon, resistant wrist extension and pronation in the elbow extension position, or static stretching of common extensor tendon through the palmer flexion in wrist pronation and elbow extension position \n\n ", - "exclusion_criteria": ": \n\n Generalized inflammatory arthritis (e.g., rheumatic arthritis) \n\n Pain at the proximal part of involved arm (e.g., shoulder pain, neck pain) \n\n Pain other than elbow pain at the involved arm \n\n Abnormal neurogenic symptom over the involved arm (e.g., radicular pain, hands numbness, hemiplegia) \n\n Wound or skin lesion at the elbow of the involved arm \n\n Pregnancy \n\n Severe local or systemic infection \n\n Malignancy \n\n Coagulopathy \n\n Cardiac pacemaker \n\n History of surgical treatment at the elbow of the involved arm \n\n Non-steroid anti-inflammatory drug (NSAID) use orally or topically at the elbow of the involved arm in the past week \n\n Local steroid injection at the elbow of the involved arm in the past 3 months \n\n Oral steroid use in the past 6 weeks \n\n Refusal to sign the informed consent \n\n Impairment in self-expression (e.g., dementia, aphasia) \n\n Inability/unwillingness to participate in all the measurements.", - "brief_summary": "Background:~Tennis elbow, also known as lateral epicondylitis, is the inflammatory status of insertion site of common extensor tendon to humerus. It is usually related to overuse of local muscle. Radial extracorporeal shock wave therapy (rESWT) is a non-invasive physical treatment. It applies shockwave energy to the lesion site, enhancing the growth of microvascularity, inducing tissue repair, and thus relieving the symptom.~The purpose of this study is to understand the therapeutic effect of rESWT to tennis elbow.~Material and Methods~Subjects: 30 patients will be recruited from outpatient department of physical medicine and rehabilitation department.~Duration: 2013.09.01-2015.05.31~Methods: The patients will be randomly divided into the experimental group and the control group through the draw, with 15 patients in each group. Patients in the experimental group receive rESWT plus routine rehabilitation program. Patients in the control group receive sham shockwave therapy plus routine rehabilitation program.~Assessment: Before the therapy starts, patients who match the inclusion criteria will be evaluated using tools mentioned below:~General data: age, sex, body height, body weight, affected side, medical history~Assess upper extremity function and symptom with Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)~Assess severity of pain with Visual Analogue Scale (VAS)~Assess grip strength with grip strength dynamometer~Measure the size of tear (if any) of common extensor tendon through ultrasonography, and assess the texture of common extensor tendon through real-time sonoelastography (RTS)~Patients will be followed up 6 weeks, 3months, and 6 months after therapy starts. They will be re-assessed of upper extremity function and symptom, severity of pain, grip strength, and presentation on ultrasonography and RTS.", - "NCTID": "NCT02596659" - }, - { - "brief_title": "Brain Computer Interface (BCI) Based Robotic Rehabilitation for Stroke", - "phase": "", - "drugs": "['Rehabilitation technique']", - "drugs_list": [ - "Rehabilitation technique" - ], - "diseases": "['Stroke']", - "diseases_list": [ - "Stroke" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Demographics: 21 to 65 years, within 12 months of first, single clinical stroke (ischaemic or haemorrhagic). \n\n Moderate to severe upper extremity (UE) weakness post stroke. \n\n Fugly-Meyer motor score of the upper limb < 40. \n\n Upper limb motor power MRC grade 3 or less /5 in at least 1 arm region. \n\n Able to give own consent and understand simple instructions and learn through practice. \n\n Resting brain states determined by FMRI criteria \n\n ", - "exclusion_criteria": ": \n\n Recurrent stroke. \n\n Previous brain surgery. \n\n Spasticity of Modified Ashworth scale > 2. \n\n Fixed contracture of any upper limb joint \n\n Ataxia, dystonia or tremor of the involved upper limb or previous cervical myelopathy \n\n Upper limb pain or painful joints in upper limb. \n\n Severe cognitive impairment (Abbreviated Mental Test <7/10), or severe aphasia which may affect ability to participate in training. \n\n . History of seizures in the past 12 months. \n\n Severe left neglect", - "brief_summary": "The trial aims to test a novel rehabilitation device for subacute stroke hemiplegic upper limbs based on state-of-the-art non invasive Brain-Computer Interface (BCI) robotic rehabilitation in a clinical setting. The investigators aim to prove the clinical efficacy and safety of BCI therapy over traditional rehabilitation methods.", - "NCTID": "NCT00955838" - }, - { - "brief_title": "Observational Study of Botox\u00ae Treatment for Patients With Upper Limb Adult Spasticity", - "phase": "", - "drugs": "['botulinum toxin Type A']", - "drugs_list": [ - "botulinum toxin Type A" - ], - "diseases": "['Muscle Spasticity']", - "diseases_list": [ - "Muscle Spasticity" - ], - "enrollment": "108.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult patients with upper limb spasticity following a stroke \n\n Eligible to receive botulinum toxin Type A \n\n No previous botulinum toxin Type A therapy \n\n ", - "exclusion_criteria": ": \n\n None", - "brief_summary": "This is a prospective, non-interventional, observational study to collect data on the use of botulinum toxin Type A in a routine setting in patients with upper limb adult spasticity.", - "NCTID": "NCT01387074" - }, - { - "brief_title": "Evaluation of BOTOX\u00ae With Rehabilitation Therapy for the Treatment of Wrist and Hand Spasticity in Post-Stroke Patients", - "phase": "Phase 1", - "drugs": "['Botox and rehab', 'Placebo and rehab']", - "drugs_list": [ - "Botox and rehab", - "Placebo and rehab" - ], - "diseases": "['Stroke']", - "diseases_list": [ - "Stroke" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female, 18 to 70 years of age \n\n Written informed consent \n\n Written Authorization for Use and Release of Health and Research Study Information has been obtained \n\n Medically stable condition in the investigator's opinion \n\n History of stroke (hemorrhagic or ischemic) that resulted in a unilateral, upper-limb focal spasticity pattern of the wrist and fingers \n\n EMG evidence of volitionary activiation of wrist and finger extensor and flexor muscles \n\n Active range of motion (to be repeated 3 times by the patient): The ability to initiate wrist extension of at least 10 degrees from a fully flexed position with the forearm supported and stabilized in a pronated position. Active shoulder flexion and abduction to 45 degrees and no less than -30 degrees of elbow extension. \n\n Mini-Mental State Exam (MMSE) >24 \n\n If on an anti-spasticity medication regiment at the time of qualification, the dose regimen must have been stable 1 month prior to study enrollment \n\n Ability to follow study instructions and likely to complete all required visits \n\n ", - "exclusion_criteria": ": \n\n Time since neurological event resulting in upper limb spasticity less than 3 months or greater than 24 months \n\n Previous therapy with BOTOX\u00ae or any other botulinum toxin serotype for any condition within the last 12 months \n\n Phenol or alcohol block in the study limb within 6 months of study enrollment visit \n\n History (within 3 months of qualification) of or planned (during study period) casting of the study limb \n\n Current treatment with an intrathecal baclofen pump \n\n In the opinion of the investigator, profound atrophy of the muscles in the study limb that are targeted for injection \n\n Previous surgical intervention in the study limb, except for routine orthopedic repair for bone fractures, in the last 6 months \n\n Presence of fixed contracture of the study limb impairing functional activity \n\n Clinically significant inflammation or condition in the study limb that, in the investigator's opinion, could limit joint movement (other than stroke or spasticity) \n\n Clinically significant spasticity or contracture of the elbow (defined as an Ashworth score >3) or shoulder in the study limb, in the investigator's opinion would limit sue of the wrist and fingers \n\n Changes in oral spasticity medications within 30 days of enrollment (dose of anti-spasticity medications should remain the same during the study) \n\n Anticipated use of oral coagulants during the study \n\n Known allergy or sensitivity to the study medication or its components \n\n Infection or dermatological condition at anticipated injection sites \n\n Current participation in another clinical study or within 1 month of the enrollment visit \n\n Females who are pregnant, nursing, or planning a pregnancy during the study, or females of childbearing potential, not using a reliable means of contraception \n\n Anticipated use during the study of concurrent therapies for treatment of upper motor neuron syndrome (eg, acupuncture) \n\n Any medical condition that may put the patient at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function \n\n Patient has a condition or is in a situation which in investigator's opinion may put the patient significant risk, may confound the study results, or may interfere significantly with patient's participation in the study", - "brief_summary": "The present study is designed to determine the safety and effectiveness of injections of BOTOX\u00ae in spastic muscles of the arm and hand compared with injections of saline (which would do nothing) when combined with rehabilitation therapy for the improvement of active function tasks in post-stroke patients. Injections will be targeted to reduce common spasticity patterns of the arm and hand which include: bent elbow, palm down forearm, bent wrist, thumb-in-palm, clenched fist, and other hand deformities. This will be done only at Emory University. Neither the doctor injecting the drug nor the subject receiving the drug will know if they are getting BOTOX\u00ae or saline. Which type of injection the subject receives will be completely randomized (like flipping a coin). All subjects will have rehabilitation therapy after their injections. Subjects will be assessed at a total of 5 scheduled visits (qualification (Week 1), Injection (Week 2), Evaluations on Weeks 8, 10, and 14. All subjects will receive rehabilitation therapy immediately after their injections for 1 hour a day, 3-5 times a week, for 4 weeks. The results from this project will provide valuable data on the ability of BOTOX\u00ae and physical rehabilitation to provide effective treatment to spastic muscles of the arm and hand after stroke. This project has the potential to increase the availability of effective rehabilitation techniques to patients with stroke.", - "NCTID": "NCT00565201" - }, - { - "brief_title": "Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury", - "phase": "Phase 3", - "drugs": "['Fampridine-SR', 'Placebo']", - "drugs_list": [ - "Fampridine-SR", - "Placebo" - ], - "diseases": "['Spinal Cord Injury', 'Muscle Spasticity']", - "diseases_list": [ - "Spinal Cord Injury", - "Muscle Spasticity" - ], - "enrollment": "204.0", - "inclusion_criteria": "inclusion criteria: \n\n Incomplete traumatic Spinal Cord Injury (at least 18 months prior and stable for 6 months) \n\n Moderate to severe lower-limb spasticity \n\n Able to give informed consent and willing to comply with protocol \n\n ", - "exclusion_criteria": ": \n\n Pregnancy \n\n History of seizures \n\n Existing or history of frequent Urinary Tract Infections \n\n History of drug or alcohol abuse \n\n Allergy to pyridine-containing substances \n\n Received a botox injection 4 months prior to study \n\n Received an investigational drug within 30 days \n\n Previously treated with 4-aminopyridine (4-AP) \n\n Not on stable medication dosing in 3 weeks prior to study \n\n Abnormal ECG or laboratory value at screening", - "brief_summary": "Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with spinal cord injury, some fibers may be destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal cord injury may have spasticity which is muscle spasms or muscle stiffness that makes movement difficult. Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as bladder control, bowel function and sexual function. The study will also examine the possible risks of taking Fampridine-SR.", - "NCTID": "NCT01683838" - }, - { - "brief_title": "A Trial of Levodopa in Angelman Syndrome", - "phase": "Phase 2; Phase 3", - "drugs": "['Levodopa', 'Placebo Oral Capsule']", - "drugs_list": [ - "Levodopa", - "Placebo Oral Capsule" - ], - "diseases": "['Angelman Syndrome']", - "diseases_list": [ - "Angelman Syndrome" - ], - "enrollment": "67.0", - "inclusion_criteria": "inclusion criteria: \n\n Age between 4 years and 12 years (i.e., before the 13th birthday) \n\n Molecular confirmation of the diagnosis of AS, which may include abnormal methylation studies or UBE3A mutation analyses - only subjects with a molecular diagnosis will be allowed to enroll \n\n Not on LD, CD, or any dopamine agonists in the 2 weeks prior to participation \n\n ", - "exclusion_criteria": ": \n\n Co-morbid disorders that may be associated with developmental or cognitive delays \n\n Poorly controlled seizures - An average of more than 2 clinical seizures per month in the 12 months prior to enrollment. \n\n Use of medications that may interact with LD/CD including atypical antipsychotics (aripiprazole, asenapine, iloperidone, olanzapine, paliperidone, risperidone, ziprasidone), monoamine oxidase inhibitors (isocarboxazid, phenelzine, selegiline, tranylcypromine), or phenytoin within the last 14 days, or other investigational interventions within the past 3 months \n\n Presence of cardiovascular disease or instability, respiratory disease, liver disease, peptic ulcer disease, renal impairment, or hematological disorders \n\n Pregnancy", - "brief_summary": "This study is designed to determine whether levodopa will lead to an improvement in the development and tremor in children with Angelman syndrome (AS).~It has been suggested that levodopa, a medication that is usually used to treat Parkinson disease in adults, may help children with AS in their overall development and reduce the tremor that some of them have.~If levodopa is found to be beneficial for children with AS, this could lead to a new treatment for AS.~Funding Source - FDA-OOPD", - "NCTID": "NCT01281475" - }, - { - "brief_title": "Safety and Efficacy of BOTOX\u00ae (Botulinum Toxin Type A) in Korea", - "phase": "", - "drugs": "['botulinum toxin Type A']", - "drugs_list": [ - "botulinum toxin Type A" - ], - "diseases": "['Hyperhidrosis', 'Muscle Spasticity', 'Glabellar Lines']", - "diseases_list": [ - "Hyperhidrosis", - "Muscle Spasticity", - "Glabellar Lines" - ], - "enrollment": "727.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients treated with BOTOX\u00ae (botulinum toxin Type A) as prescribed according to standard of care in clinical practice for primary axillary hyperhidrosis, focal spasticity or moderate to severe glabellar lines. \n\n ", - "exclusion_criteria": ": \n\n None.", - "brief_summary": "This post marketing surveillance study in Korea will evaluate the safety and efficacy of BOTOX (botulinum toxin Type A) in patients who receive treatment according to standard of care for primary axillary hyperhidrosis, focal spasticity or moderate to severe glabellar lines in clinical practice.", - "NCTID": "NCT02043145" - }, - { - "brief_title": "Robot-Assisted Motivating Rehabilitation", - "phase": "Phase 1", - "drugs": "['TheraDrive Assistive Device', 'Rote Therapy versus Fun Therapy']", - "drugs_list": [ - "TheraDrive Assistive Device", - "Rote Therapy versus Fun Therapy" - ], - "diseases": "['Stroke', 'Cerebrovascular Accident']", - "diseases_list": [ - "Stroke", - "Cerebrovascular Accident" - ], - "enrollment": "24.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects will be included in the study on the basis of the following criteria: \n\n They must be at least six months post-stroke. \n\n 18 years of age or older with a clinical diagnosis of hemiparesis (as verified by medical record and a medical expert). \n\n They have voluntary control with a low to medium range of motion function (UE-FT<5) and a muscle tone. \n\n They are functionally stable (no significant changes in motor function over a week) and are able to tolerate being seated upright for 90 minutes. \n\n They report no excessive pain the impaired arm. \n\n If left neglect or spasticity is detected in the impaired arm, these levels must not interfere with the ability to cognitively complete the tasks or turn a wheel. \n\n They must not be participating in any experimental rehabilitation or drug therapies. \n\n If subjects are receiving chemical injections for spasticity, they must be at least 3-months away from their last treatment. \n\n They must have driven prior to stroke. \n\n They are not clinically depressed (as measured by the Geriatric Depression Scale (GDS) short form (Sheikh and Yesavage, 1986). \n\n ", - "exclusion_criteria": ": \n\n Subjects will be excluded from the study if they voluntarily decide to withdraw from the study or if they do not meet the above inclusion criteria. \n\n Once informed consent is given twenty-four of these subjects will be randomized into two training groups (fun driving: fun and functional driving activities and rote tracking (12 subjects): rote and functional tracking activities). Two subjects will be randomized the case study group. The groups will be matched in initial motor function. \n\n Subjects will be excluded if they voluntarily decide to withdraw from the study or if they do not meet the above inclusion criteria.", - "brief_summary": "The purpose of the study is to examine how a novel robot technology designed for eventual use as a home therapy can improve arm function after stroke.", - "NCTID": "NCT00393926" - }, - { - "brief_title": "IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Post-stroke Spasticity of the Upper Limb", - "phase": "Phase 3", - "drugs": "['IncobotulinumtoxinA (Xeomin)', 'Placebo']", - "drugs_list": [ - "IncobotulinumtoxinA (Xeomin)", - "Placebo" - ], - "diseases": "['Post-stroke Upper Limb Spasticity']", - "diseases_list": [ - "Post-stroke Upper Limb Spasticity" - ], - "enrollment": "148.0", - "inclusion_criteria": "Main inclusion criteria: \n\n Female or male patients \u2265 18 years \n\n \u2265 6 months since the last stroke, diagnosed by an appropriate health care professional (e.g., neurologist) \n\n Focal spasticity with \u2265 2 points on the Ashworth Scale in the wrist flexors with clinical pattern Flexed Wrist \n\n Focal spasticity with \u2265 2 points on the Ashworth Scale in the fingers flexors with clinical pattern Clenched Fist \n\n For pre-treated patients only: source documentation of the most recent injection session with Botulinum Toxin and sufficient therapeutic response for Flexed Wrist and Clenched Fist \n\n For pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 50 Units BOTOX\u00ae or 200 Units Dysport\u00ae or 2000 Units Neurobloc\u00ae (type B preparation) per each of these flexors: carpi ulnaris, digitorum superficialis, digitorum profundus \n\n For pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 60 Units BOTOX\u00ae or 240 Units Dysport\u00ae or 2400 Units Neurobloc\u00ae (type B preparation) for flexor carpi radialis \n\n Main ", - "exclusion_criteria": ": \n\n Spasticity of any other origin than stroke \n\n Previous treatment with Botulinum Toxin of any serotype and for any body region within the 4 months prior to Screening (Visit 1, Day -7) \n\n Planned concomitant treatment with Botulinum Toxin of any serotype and for any body region \n\n Previous or planned treatment with phenol- or alcohol-injection in the target limb \n\n Previous surgical treatment of spasticity in the target muscle(s) \n\n Fixed contracture, defined as severe restriction of the range of joint movement on passive stretch \n\n Severe atrophy of the target limb muscles", - "brief_summary": "IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free from complexing proteins, i.e. free from proteins other than the active toxin. Injected into the muscle, incobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for treatment of various neurological conditions. This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of post-stroke spasticity of the upper limb.", - "NCTID": "NCT00432666" - }, - { - "brief_title": "Robot Aided Rehabilitation - Multi-joint Evaluations", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Stroke']", - "diseases_list": [ - "Stroke" - ], - "enrollment": "56.0", - "inclusion_criteria": "inclusion criteria: \n\n First focal unilateral lesion, ischemic or hemorrhagic \n\n Had a stroke less than a month prior to enrollment \n\n Rated between stages 1-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Arm \n\n Rated between stages 1-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Hand \n\n ", - "exclusion_criteria": ": \n\n Apraxia \n\n Other unrelated or musculoskeletal injuries \n\n Unable to sit in a chair for 3 consecutive hours \n\n Score of less than 22 on the Mini Mental Status Exam \n\n Poor fit into equipment used in study which compromises proper use. This will be determined by the judgment of study staff", - "brief_summary": "Sensory and motor impairments following stroke can lead to substantial disability involving the arm and hand. The investigator hypothesized that excessive local and cross-coupled stiffness, diminished individuation and proprioceptive acuity will be present among multiple degree of freedom in the upper limb. The stiffness and spasticity will increase with time post-stroke. The objective of this study is to quantify the progression throughout the arm and hand during recovery from stroke. The investigator will measure the clinical assessment scores, and neuromechanical properties including range of motion, active and passive cross coupling, and spasticity by the IntelliArm robot.", - "NCTID": "NCT02359812" - }, - { - "brief_title": "Efficacy of Functional Electrical Stimulation (FES) in Persons Receiving Botulinum Neurotoxin for Upper Extremity Spasticity", - "phase": "", - "drugs": "['Functional Electrical Stimulation (FES) through the Ness H200']", - "drugs_list": [ - "Functional Electrical Stimulation (FES) through the Ness H200" - ], - "diseases": "['Upper Extremity Spasticity', 'Stroke', 'Acquired Brain Injury']", - "diseases_list": [ - "Upper Extremity Spasticity", - "Stroke", - "Acquired Brain Injury" - ], - "enrollment": "23.0", - "inclusion_criteria": "inclusion criteria: \n\n Minimum 6 months post injury/insult with unilateral upper limb spasticity of the elbow, wrist and/or finger flexors. \n\n Preinjection Modified Ashworth scores > 2 in at least one of the following areas: elbow, wrist, or finger flexors. \n\n Subjects must meet criteria for CMA Hand Impairment Scale Stage 2 and be able to complete Task 3 (thumb to index finger) of the CMA Hand Impairment Scale Stage 3, or demonstrate 50% gross grasp to be included. \n\n Botulinum toxin A (Botox\u00ae) stable patients (have received at least two prior doses of the agent with first dose occurring at least 6 months prior to study enrollment). \n\n Able to answer reliably to yes/no questions. \n\n Able to follow reliably 1-step instructions. \n\n Written informed consent. \n\n Females enrolled in this study who are of childbearing age will be required to use adequate measures of birth control for the entire study period. Those who do not agree will be excluded. \n\n ", - "exclusion_criteria": ": \n\n Uncontrolled, clinically significant medical condition other than the condition under evaluation. \n\n Severe, fixed joint contracture in the affected arm. Patients with mild contracture that does not significantly impact function will be included based upon the assessment of the PI. \n\n Known allergy or sensitivity to any of the components in the study medication. \n\n Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study. \n\n Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment. \n\n Treatment with botulinum toxin of any serotype for any reason in less than 3 months prior to initial date of injection for the study. \n\n Any medical condition that may put the subject at increased risk with exposure to botulinum toxin type A including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function. \n\n Evidence of recent alcohol or drug abuse. \n\n Infection or skin disorder at an anticipated injection and/or electrical stimulation sites. \n\n Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study. \n\n Use of aminoglycoside antibiotics, curare like agents, or other agents that might interfere with neuromuscular function. \n\n Individuals with a cardiac pacemaker, a defibrillator, or baclofen pump. \n\n Individuals with an unhealed or healing fracture or dislocation in the arm to be evaluated.", - "brief_summary": "FES is a form of treatment with a device to aid movement in people who have had damage to their brain or spinal cord. Small electrical impulses are used to excite/stimulate the nerves that supply paralyzed muscles. This activates those muscles, enabling them to produce basic but useful movement. Self-adhesive patches (electrodes) are placed on the skin close to the nerve that supplies the muscle and are connected by wires to a stimulator that produces the impulses. In this way, FES is used to correct the muscle weakness that is caused by injury to the brain or spinal cord.~Repetitive task practice is an activity-based therapy program that has been shown to enhance the recovery of hand and arm functions after stroke. This therapy consists of a set of training activities that are designed by a qualified therapist specific to your functional abilities that are to be performed with the impaired hand. These activities are designed to stimulate functional improvement with repetitive practice.~Spasticity is a nervous system disorder where certain muscles are continuously contracted. Botox injections are commonly used to help to reduce spasticity in areas of the body with increased muscle tone. This research is designed to look at any additional benefit that may occur when Botox injections are combined with specific occupational therapy exercises and with a device that uses functional electrical stimulation (FES) to help improve muscle function after stroke.", - "NCTID": "NCT00462449" - }, - { - "brief_title": "Lateral Cord Stimulation as a New Treatment for Refractory Spastic Cerebral Palsy", - "phase": "", - "drugs": "['Lateral spinal cord surgical implant of electrodes']", - "drugs_list": [ - "Lateral spinal cord surgical implant of electrodes" - ], - "diseases": "['Cerebral Palsy', 'Spasticity']", - "diseases_list": [ - "Cerebral Palsy", - "Spasticity" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged sixteen or older \n\n Spastic Cerebral Palsy with stable condition \n\n Motor disability unilateral or predominantly unilateral. \n\n Troubles of speech clinically evident. \n\n Normal or Slightly sub-normal I.Q \n\n No psychiatric disorders. \n\n ", - "exclusion_criteria": ": \n\n Severe cardiac or respiratory troubles \n\n Fixed abnormal postures (except if previously corrected by orthopedic surgery) \n\n Chronic recurrent bronchial or pulmonary infections \n\n Chronic recurrent urinary infections \n\n Severe osteoporosis on affected limbs \n\n Chronic skin ulcerations.", - "brief_summary": "The aim of our work is to investigate whether electrical Lateral Cord Stimulation (LCS) causes an inhibitory and modulatory action by indirect cerebellar activation, so releasing spasticity and the spastic syndrome in selected cases of patients with cerebral palsy", - "NCTID": "NCT02199015" - }, - { - "brief_title": "Effect of Osteopathic Manipulative Medicine on Motor Function and Quality of Life in Cervical Dystonia", - "phase": "", - "drugs": "['Osteopathic Manipulative Medicine']", - "drugs_list": [ - "Osteopathic Manipulative Medicine" - ], - "diseases": "['Cervical Dystonia']", - "diseases_list": [ - "Cervical Dystonia" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n clinical diagnosis of cervical dystonia or spasmodic torticollis \n\n ages 2-100 \n\n ", - "exclusion_criteria": ": \n\n no clinical diagnosis of cervical dystonia or spasmodic torticollis \n\n symptoms beginning over the age of 40 \n\n pregnant women are excluded from Aim 2", - "brief_summary": "The purpose of the proposed research is to determine if Osteopathic manipulative medicine (OMM) used alone or in combination with the standard treatment of botulinum toxin intramuscular injections improves motor function and quality of life amongst people with cervical (neck) dystonia.", - "NCTID": "NCT02420106" - }, - { - "brief_title": "A Phase 1/2b Study of an Investigational Malaria Vaccination Strategy in 5-17 Month Old Infants and Children in Burkina Faso", - "phase": "Phase 1; Phase 2", - "drugs": "['ChAd63 ME-TRAP and MVA ME-TRAP', 'Rabies vaccine']", - "drugs_list": [ - "ChAd63 ME-TRAP and MVA ME-TRAP", - "Rabies vaccine" - ], - "diseases": "['Malaria']", - "diseases_list": [ - "Malaria" - ], - "enrollment": "730.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy infant/child aged 5-17 months at the time of first study vaccination \n\n Informed consent of parent/guardian \n\n Infant / child and parent/guardian resident in the study area villages and anticipated to be available for vaccination and follow-up \n\n ", - "exclusion_criteria": ": \n\n Clinically significant skin disorder (psoriasis, contact dermatitis etc.), immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness. \n\n Weight-for-age Z score of less than -3 or other clinical signs of malnutrition \n\n History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation \n\n History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, beta-propiolactone. \n\n Haemoglobin less than 8.0 g/dL, where judged to be clinically significant in the opinion of the investigator \n\n Serum Creatinine concentration greater than 70 \u00b5mol/L, where judged to be clinically significant in the opinion of the investigator \n\n Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator \n\n Blood transfusion within one month of enrolment \n\n Previous vaccination with experimental malaria vaccines. \n\n Administration of any other vaccine or immunoglobulin less than one week before vaccination with any study vaccine. \n\n Current participation in another clinical trial, or within 12 weeks of this study. \n\n Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial or result in incomplete or poor quality data \n\n Known maternal HIV infection (No testing will be done by the study team) \n\n Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within 3 months prior recruitment. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)", - "brief_summary": "Prime boost vaccination with ChAd63 ME-TRAP followed eight weeks later with MVA ME-TRAP shows efficacy against malaria infection when tested in UK volunteers using sporozoite challenge experiments. It is a leading candidate vaccination strategy against malaria. In the field, Phase I studies have been conducted in adults in Kenya and The Gambia and children and infants in The Gambia. The vaccination strategy appears safe and well tolerated in these populations, and also shows impressive immunogenicity, not significantly different to that seen in the UK trials where efficacy was shown. In particular, recent data from The Gambia shows excellent safety and immunogenicity in infants in malaria endemic areas, who would be the ones to benefit most from such a vaccine against malaria. With this clinical development as background, the investigators now propose to evaluate efficacy against natural malaria infection in this important target group for an effective malaria vaccine, that is, 5-17 month infants and children living in malaria endemic areas. The proposed study area, Banfora, Burkina Faso, is highly endemic for Plasmodium falciparum malaria.", - "NCTID": "NCT01635647" - }, - { - "brief_title": "Postoperative Distress and Cosmetic Outcomes After Open Versus Robotic Thyroidectomy", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Thyroidectomy', 'Distress', 'Surgery']", - "diseases_list": [ - "Thyroidectomy", - "Distress", - "Surgery" - ], - "enrollment": "84.0", - "inclusion_criteria": "inclusion criteria: \n\n (a) a minimally invasive follicular thyroid carcinoma \u22644 cm in diameter, or \n\n (b) a papillary thyroid carcinoma \u22642 cm in diameter. \n\n ", - "exclusion_criteria": ": \n\n (a) previous neck operations; \n\n (b) age <21 or >65 years; \n\n (c) prior vocal fold paralysis or a history of voice or laryngeal disease requiring therapy; \n\n (d) a malignancy with definite extrathyroid invasion, multiple lateral neck node metastasis, perinodal infiltration at a metastatic lymph node, or distant metastasis; and/or \n\n (e) a lesion located in the thyroid dorsal area (especially adjacent to the tracheoesophageal groove) caused by possible injury to the trachea, esophagus, or recurrent laryngeal nerve (RLN)", - "brief_summary": "Robotic assistance during thyroid surgery has been utilized clinically in Korea since late 2007. Robotic thyroidectomy has also been validated for surgical management of the thyroid gland. Compared with endoscopic thyroidectomy, the use of a robot in an endoscopic approach via the axilla provides a broader view of the thyroid bed, albeit from a lateral, as opposed to the conventional anterior, perspective. The wrist action of a surgical robot also provides a greater degree of movement than afforded by the use of simple endoscopic instruments, and tremor is eliminated.~Although several reports on operative outcomes of the robotic technique have appeared, no prospective trials comparing the clinical results of robotic with conventional open thyroidectomy have been described. We therefore designed a prospective trial comparing outcomes, including postoperative distress and patient satisfaction, between patients undergoing robotic and conventional open thyroidectomy.", - "NCTID": "NCT01075269" - }, - { - "brief_title": "Effects of Intensive Robot-assisted Therapy in Patients With Subacute Stroke", - "phase": "", - "drugs": "['RT', 'Conventional rehabilitation (CR)']", - "drugs_list": [ - "RT", - "Conventional rehabilitation (CR)" - ], - "diseases": "['Stroke']", - "diseases_list": [ - "Stroke" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n first episode of unilateral stroke \n\n time since stroke less than 3 months, i.e., acute or subacute stage \n\n initial motor part of upper limb of FMA score ranging from 10 to 40, indicating severe to moderate movement impairment \n\n no serious cognitive impairment (i.e., Mini Mental State Exam score > 23) \n\n ", - "exclusion_criteria": ": \n\n pregnant or breastfeeding women \n\n aphasia that might interfere with understanding instructions \n\n major health problems or poor physical conditions that might limit participation \n\n currently participation in any other research. Potential participants will be also excluded if they have any contraindication to fMRI scanning including claustrophobia, seizures, the presence of pacemaker, mental elements (e.g., steel nails) inside the body or in the eyes, and excessive obesity.", - "brief_summary": "Robot-assisted training (RT) devices developed to date have a significant impact on stroke rehabilitation. Several research groups have developed the robotic devices and examined their efficacy on improving upper limb function after stroke. All these robotic devices have been applied in stroke rehabilitation and their efficacy are evaluated, but the scientific evidence for the mechanisms of RT-induced recovery, the optimal treatment intensity, and the impact on physiological responses is still lacking.~This trial is to examine (1) the immediate effects of treatment intensity in RT on sensorimotor impairments and functional performance in patients with subacute stroke; (2) the long-term benefits of treatment intensity in RT by conducting a 6-month follow up evaluation; and (3) the effects of RT on cortical/movement reorganization as well as on the physiological markers of inflammation, oxidative stress, and erythrocyte deformability. These overall findings will help better understanding of the efficacy of RT on functional outcomes, brain and movement reorganization, and physiological markers.", - "NCTID": "NCT01767480" - }, - { - "brief_title": "Improving Hand Use in Multiple Sclerosis", - "phase": "Phase 2", - "drugs": "['CI Therapy', 'CAM treatments']", - "drugs_list": [ - "CI Therapy", - "CAM treatments" - ], - "diseases": "['Multiple Sclerosis']", - "diseases_list": [ - "Multiple Sclerosis" - ], - "enrollment": "66.0", - "inclusion_criteria": "inclusion criteria: \n\n diagnosis of non-relapsing multiple sclerosis (primary progressive MS, secondary progressive MS) \n\n reduced use of one of the hands because of MS \n\n ability to pick up and release a small object with the more-affected hand when requested \n\n can travel to the treatment program at the University of Alabama at Birmingham (UAB) \n\n can undergo treatment for 2 weeks (Monday-Friday), 3.5 hours per day \n\n can undergo MRI scan \n\n any kind of medication used for MS is allowed except spasticity medicine \n\n ", - "exclusion_criteria": ": \n\n disease relapse in the past 3 months \n\n pregnancy \n\n marked pain with arm movement \n\n severe uncontrolled medical illness \n\n simultaneous treatment with another form of physical therapy", - "brief_summary": "This study will compare two different kinds of physical therapy to improve use of the hands in individuals with multiple sclerosis (MS). One treatment will be Constraint-Induced Movement therapy (CI therapy), the other will be a set of Complementary and Alternative Medicine (CAM) treatments (yoga, relaxation exercises, aquatherapy, massage). The study will determine which of the two forms of treatment is more successful for improving hand use.", - "NCTID": "NCT01081275" - }, - { - "brief_title": "AdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Adults and Children in a Malaria Endemic Area", - "phase": "Phase 1", - "drugs": "['AdCh63 ME-TRAP, MVA ME-TRAP', 'AdCh63 ME-TRAP, MVA ME-TRAP', 'AdCh63 ME-TRAP, MVA ME-TRAP', 'AdCh63 ME-TRAP, MVA ME-TRAP', 'HDCRV', 'AdCh63 ME-TRAP, MVA ME-TRAP', 'AdCh63 ME-TRAP, MVA ME-TRAP', 'HDCRV']", - "drugs_list": [ - "AdCh63 ME-TRAP", - "MVA ME-TRAP", - "AdCh63 ME-TRAP", - "MVA ME-TRAP", - "AdCh63 ME-TRAP", - "MVA ME-TRAP", - "AdCh63 ME-TRAP", - "MVA ME-TRAP", - "HDCRV", - "AdCh63 ME-TRAP", - "MVA ME-TRAP", - "AdCh63 ME-TRAP", - "MVA ME-TRAP", - "HDCRV" - ], - "diseases": "['Malaria']", - "diseases_list": [ - "Malaria" - ], - "enrollment": "52.0", - "inclusion_criteria": "inclusion criteria: \n\n Consenting adult males aged 18-50 years in good health and healthy children aged 2-6 years.with consenting parents. \n\n ", - "exclusion_criteria": ": \n\n Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness. \n\n Severe malnutrition. \n\n Hypersensitivity to HDCRV. \n\n History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone. \n\n History of splenectomy Haemoglobin less than 9.0 g/dL, where judged to be clinically significant in the opinion of the investigator \n\n Serum Creatinine concentration greater than 70 mol/L, where judged to be clinically significant in the opinion of the investigator \n\n Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator \n\n Blood transfusion within one month of enrolment. \n\n History of vaccination with previous experimental malaria vaccines. \n\n Administration of any other vaccine or immunoglobulin within two weeks before vaccination. \n\n Current participation in another clinical trial, or within 12 weeks of this study. \n\n Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial. \n\n Likelihood of travel away from the study area. \n\n HIV positive. \n\n Positive malaria antigen test", - "brief_summary": "The purpose of this trial is to assess the safety and immunogenicity of MVA ME-TRAP and AdCH63 ME-TRAP candidate vaccines in healthy children and adult volunteers in a malaria endemic region. The regimen proposed here has protected non-immune volunteers in Oxford against sporozoite challenge, and so may be protective against naturally acquired infection in The Gambia.", - "NCTID": "NCT01373879" - } - ], - "1": [ - { - "brief_title": "Immunogenicity of Rabies Vaccine for Pre Exposure Prophylaxis", - "phase": "Phase 4", - "drugs": "['Rabies vaccine', 'Placebo']", - "drugs_list": [ - "Rabies vaccine", - "Placebo" - ], - "diseases": "['Rabies']", - "diseases_list": [ - "Rabies" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and non-pregnant females aged \u2265 18 to \u2264 60 years on the day of inclusion Able to comprehend and give informed consent Able to attend all scheduled visits and to comply with all trial procedures Subject in good health, based on medical history and physical examination \n\n ", - "exclusion_criteria": ": \n\n Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post- menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination). \n\n Participation in the 4 weeks preceding the first trial vaccination, or planned participation during the present trial period, in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. \n\n Previous history of receiving the rabies vaccine. \n\n Previous history of receiving rabies immune globulin. \n\n Any major psychiatric disorder, such as severe depression, severe anxiety disorder, psychosis, schizophrenia, other major psychiatric disorders, or seizures. History of mild depression or anxiety disorder that is well controlled is not an ", - "brief_summary": "The purpose of this study is to compare the effectiveness of a two dose versus a three dose schedule and intramuscular versus intradermal injection for pre-exposure prophylaxis.", - "NCTID": "NCT02374814" - }, - { - "brief_title": "Immune Response After Booster Vaccination in HIV - Infected Patients Who Received Rabies Primary Vaccination", - "phase": "", - "drugs": "['rabies vaccines on day 0 and 3']", - "drugs_list": [ - "rabies vaccines on day 0 and 3" - ], - "diseases": "['Rabies', 'HIV']", - "diseases_list": [ - "Rabies", - "HIV" - ], - "enrollment": "33.0", - "inclusion_criteria": "inclusion criteria: \n\n HIV infected patients 18-60 years of age \n\n Ever received primary rabies immunization \n\n ", - "exclusion_criteria": ": \n\n currently have any active opportunistic infections \n\n have received blood or blood product within previous 3 months \n\n history of allergy to vaccine or any vaccine components \n\n currently received anti-malarial drugs", - "brief_summary": "Booster rabies vaccination in HIV - infected patients who have ever received rabies primary vaccination could improve their immune response to this kind of vaccine.", - "NCTID": "NCT01286493" - }, - { - "brief_title": "Safety and Tolerability of CV8102 Alone and in Combination With a Rabies Virus Vaccine in Healthy Adults", - "phase": "Phase 1", - "drugs": "['CV8102', 'Rabipur', 'CV8102 + Rabipur']", - "drugs_list": [ - "CV8102", - "Rabipur", - "CV8102 + Rabipur" - ], - "diseases": "['Rabies']", - "diseases_list": [ - "Rabies" - ], - "enrollment": "72.0", - "inclusion_criteria": "inclusion criteria: \n\n Compliant with protocol procedures and available for clinical F/U until the protocol-defined end of the trial \n\n Physical examination and laboratory results without clinically significant findings \n\n Body Mass Index (BMI) \u2265 18.0 and \u2264 32.0 kg/m2 \n\n Subjects must use reliable forms of contraception (barrier method with spermicidal agent or true abstinence) and must refrain from sperm donation during treatment and the 4-week F/U period after the last treatment. \n\n ", - "exclusion_criteria": ": \n\n Use of any investigational or non-registered product (adjuvant, drug) other than CV8102 within 4 weeks preceding the administration of the CV8102, or planned use of any such agent during the trial period \n\n Subject has received any licensed or non-licensed vaccines within 4 weeks prior to the administration of CV8102 alone or in combination with the licensed rabies vaccine or planned vaccinations during the trial period \n\n Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of CV8102 alone or in combination with the licensed rabies vaccine. The use of inhaled and nasal steroids, as well as topical steroids outside the vaccination area, will be permitted \n\n Any medically diagnosed or suspected immune deficient condition based on medical history and physical examination \n\n History of autoimmune disease or suspected autoimmune disease based on medical history and physical examination that cannot be ruled out based on further examinations \n\n Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of CV8102 or licensed rabies vaccine \n\n Acute disease at the time of enrolment. Acute disease is defined as the presence of any acute condition including but not limited to non-febrile or febrile common colds, urinary tract infections, inflammatory, allergic or traumatic conditions that may interfere with safety assessment of the investigational products \n\n Presence or evidence of significant acute or chronic disease, in particular heart disease including coronary artery disease and chronic pulmonary diseases (e.g., chronic obstructive pulmonary disease [COPD]); uncontrolled medical or psychiatric illness (subjects with uncomplicated chronic diagnoses stable and treated for \u2265 3 months e.g., mild hypertension well-controlled with medication, may be enrolled - provided the condition and its therapy are known not to be associated with an immunocompromised state or an autoimmune disease) \n\n Major congenital defects \n\n Known allergy to any component (or closely related substance) of the licensed rabies vaccine product \n\n Known type I allergy to beta-lactam antibiotics \n\n Evidence of current alcohol or drug abuse \n\n History of any neurological disorders or seizures \n\n Known seropositivity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) (except in subjects previously vaccinated against HBV) or hepatitis C virus (HCV) \n\n Foreseeable non-compliance with protocol as judged by the Investigator \n\n History of any life-threatening anaphylactic reactions \n\n Subjects with impaired coagulation in whom an IM injection is contraindicated. \n\n Additional ", - "brief_summary": "The purpose of this clinical trial is to investigate the safety and tolerability of IM administered CV8102 and an IM administered combination of CV8102 and rabies vaccine in humans.", - "NCTID": "NCT02238756" - }, - { - "brief_title": "1-Octanol to Treat Essential Tremor", - "phase": "Phase 1", - "drugs": "['1-Octanol']", - "drugs_list": [ - "1-Octanol" - ], - "diseases": "['Essential Tremor']", - "diseases_list": [ - "Essential Tremor" - ], - "enrollment": "12.0", - "inclusion_criteria": "Patients with essential tremor affecting the upper limbs who are 21 years of age or older. \n\n Patients who are not taking medications for essential tremor or any other medical condition for at least 2 weeks. \n\n Patients who have not consumed alcohol or cold medications containing alcohol for at least 24 hours prior to the day of the study. \n\n Women must not be pregnant or lactating. Women of childbearing age must use birth control while participating in this study. \n\n Patients must not have any neurological disease other than tremor (e.g., Parkinson's disease). \n\n Patients must not have evidence of thyroid, liver, kidney or chronic lung disease.", - "exclusion_criteria": "", - "brief_summary": "This study will evaluate the safety and effectiveness of the food additive 1-octanol for treating essential tremor. This disorder, which is an involuntary shaking, usually of the hands, has no satisfactory treatment. It affects more than one of every 100 people in the general population, with the figure climbing to nearly 4 in every hundred among people over 40 years old. In animal studies, 1-octanol reduced chemically induced tremors in rats. This study will test the effects of the accepted daily intake of 1-octanol (1 milligram per kilogram of body weight) on essential tremor in humans.~Patients with essential tremor 21 years old and older who wish to enroll in this study will undergo eligibility screening with a medical history and physical examination that includes tests for thyroid, liver and kidney problems. Participants will be randomly assigned to receive either 1-octanol or a placebo (an inactive substance). Patients in both groups will have an intravenous catheter (a thin, plastic tube) placed in an arm vein for collecting blood samples during the study. Those in the 1-octanol group will be given a 1-octanol capsule; the placebo group will receive a look-alike capsule containing no active ingredient. Neither the patient nor the doctor will know which patients are taking 1-octanol or placebo until the end of the study.~Tremors will be measured once before the catheter is placed, every 15 minutes during the first 2 hours after taking the capsule, twice during the third hour (30 minutes apart), and once again after 5 hours. The tremors are measured using procedures called accelerometry and surface electromyography. For these procedures, electrodes are taped to the skin; needles are not used. Blood samples will be collected once before taking the capsule, every 15 minutes for the first hour and a half after taking the capsule and again at 2 hours, 4 hours and 5 hours after taking the capsule. Vital signs (blood pressure, pulse, and respiratory rate) will be measured every 15 minutes during the first 2 hours of taking the capsule, every 30 minutes during the third hour, and again at 4 hours and 5 hours.~Participants will stay in the hospital overnight for observation and return after 3 days for a follow-up physical examination, including a blood test.", - "NCTID": "NCT00001986" - }, - { - "brief_title": "Characteristics of Idiopathic Familial Voice Disorders", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Laryngeal Disease', 'Spastic Dysphonia', 'Voice Disorder']", - "diseases_list": [ - "Laryngeal Disease", - "Spastic Dysphonia", - "Voice Disorder" - ], - "enrollment": "270.0", - "inclusion_criteria": "inclusion criteria: \n\n Symptoms present during speech and not apparent at rest, \n\n Symptoms less evident during whisper, singing or falsetto. \n\n Symptoms become worse with prolonged speaking, practice or anxiety. \n\n Reflexive and emotional aspects of voice function are unaffected, such as coughing, laughter or crying. \n\n ", - "exclusion_criteria": ": \n\n Any patient with a history of airway obstruction will be excluded from the study. \n\n Structural abnormalities affecting the larynx such as vocal fold nodules, polyps, carcinoma, cysts, contact ulcers, or inflammation (laryngitis). \n\n Reduction in vocal fold movement range during non-speech tasks such as whistling which would suggest either paralysis or paresis, joint abnormality or neoplasm. \n\n No smokers or tobacco users will be included in the study. \n\n Subjects with history of a psychiatric disorder, under the care of a psychiatrist, or on medications for treatment of a psychiatric disorder will be excluded from the study. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, currently under treatment for a major depression, or a history of schizophrenia or a bipolar disorder. However, a history of a previous episode of a minor reactive depression would not exclude a person from participation.", - "brief_summary": "The purpose the study is to determine the genetic causes of specific voice disorders that run in families. Researchers are particularly interested in two conditions;~Spasmodic dysphonia~Vocal fold paralysis~Familial vocal fold paralysis can be a life-threatening disorder that can cause difficulty with vocal fold movement for breathing and voice and sometimes for swallowing. Studies are ongoing at the NIH to better understand the pathophysiology and to relate it to the genetic pattern of inheritance. Families are being recruited to participate in these studies and are being provided with further information on the disorder and genetic counseling if desired. Physician referral is requested for affected members of families with vocal fold paralysis of an unknown cause occurring over at least 2 generations. All travel, lodging, examination and counseling costs are covered for both affected and unaffected members of a family. Examinations include: voice, laryngeal, neurological, electrodiagnostic testing, genetic counseling, and radiological studies....", - "NCTID": "NCT00001552" - } - ], - "2": [] - }, - { - "patient_id": "sigir-201417", - "patient": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", - "0": [ - { - "brief_title": "Efficacy and Safety of Vivaglobin\u00ae in Previously Untreated Patients With Primary Immunodeficiency", - "phase": "Phase 4", - "drugs": "['Vivaglobin']", - "drugs_list": [ - "Vivaglobin" - ], - "diseases": "['Common Variable Immunodeficiency', 'Agammaglobulinemia']", - "diseases_list": [ - "Common Variable Immunodeficiency", - "Agammaglobulinemia" - ], - "enrollment": "18.0", - "inclusion_criteria": "Key inclusion criteria: \n\n Written informed consent, age-adapted \n\n Male or female aged 1 to 70 years \n\n Diagnosis of primary humoral immunodeficiency \n\n No prior immunoglobulin substitution therapy \n\n IgG level of <5 g/L at screening \n\n Women of childbearing potential must use medically approved contraception and must have a negative urine pregnancy test at screening \n\n Key ", - "exclusion_criteria": ": \n\n Evidence of serious infection between screening and first treatment \n\n Bleeding disorders that require medical treatments \n\n Any medical disorder causing secondary immune disorders, autoimmune neutropenia, or a clinically significant defect in cell mediated immunity \n\n Any condition likely to interfere with evaluation of the study drug or satisfactory conduct of the trial", - "brief_summary": "The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation period. The purpose is to investigate whether PUPs will respond to subcutaneous immunoglobulin (SCIG) treatment with adequate trough levels without first receiving immunoglobulins by the intravenous route by demonstrating that 100 mg immunoglobulin G/kg body weight (IgG/kg bw) administered on 5 consecutive days (i.e. resulting in a total dose of 500 mg IgG/kg bw) results in an IgG increase to \u2265 5 g/L on Day 12 after initiation of SCIG therapy.", - "NCTID": "NCT00520494" - }, - { - "brief_title": "Antibiotics Versus Surgery in Acute Appendicitis", - "phase": "Phase 4", - "drugs": "['Ertapenem', 'appendectomy']", - "drugs_list": [ - "Ertapenem", - "appendectomy" - ], - "diseases": "['Acute Appendicitis Without Peritonitis']", - "diseases_list": [ - "Acute Appendicitis Without Peritonitis" - ], - "enrollment": "218.0", - "inclusion_criteria": "inclusion criteria: \n\n patients between 18 and 65 years old \n\n first episode of suspected AA diagnosed by Andersson's score or combination with abdominal ultrasound \n\n ", - "exclusion_criteria": ": \n\n patients with any potential immunodeficiency status \n\n assumption of antibiotics for different infectious disease or surgery in the last 30 days \n\n allergy to antibiotics established in the study protocol \n\n no acceptance of study protocol \n\n pregnancy or delivery in the last 6 months \n\n ASA IV or V, no Italian or English fluently speakers.", - "brief_summary": "The acute appendicitis (AA) is a very common disease with a life time risk 7-8% and the highest incidence in the second decades . The aetiology of AA is still poor understood: the commonest hypothesis refers to appendix obstruction followed by impairment of wall appendix barrier and thus wall perforation and/or abscess formation1. However some studies suggest that no-complicate and complicate appendicitis are different entities allowing a different treatment. The study aims to test the no inferiority in terms of efficacy of antibiotic treatment compared to surgery in a population with high probability to suffer of 1st episode of AA.The study aims to test the no inferiority in terms of efficacy of antibiotic treatment compared to surgery in a population with high probability to suffer of 1st episode of AA.", - "NCTID": "NCT01421901" - }, - { - "brief_title": "Prognosis of Failure Treatment of Amebic Liver Abscess", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Amebic Liver Abscess']", - "diseases_list": [ - "Amebic Liver Abscess" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical, ultrasonographic and serologic diagnosis (ELISA) of amebic liver abscess. \n\n Both genders \n\n Older 15 years \n\n ", - "exclusion_criteria": ": \n\n Clinically suspected piogenous liver abscess \n\n Positive hemoculture \n\n Negative ELISA for amoebic antigens \n\n Immunosupresion (HIV) \n\n Abdominal or biliary surgery antecedents \n\n Abdominal neoplasia antecedents", - "brief_summary": "Amebic liver abscess is the most frequent extra-intestinal form of the amoebiasis; actually the factors for predicting failure in the medical treatment are not clear. We conducted trial for determining the clinical value of paraclinical factor in this issue.", - "NCTID": "NCT00641992" - }, - { - "brief_title": "Effects of Drainage in Laparoscopic Cholecystectomy", - "phase": "", - "drugs": "['Laparoscopic cholecystectomy with drain insertion']", - "drugs_list": [ - "Laparoscopic cholecystectomy with drain insertion" - ], - "diseases": "['Empyema of Gallbladder', 'Abscess of Gallbladder', 'Acute Cholecystitis']", - "diseases_list": [ - "Empyema of Gallbladder", - "Abscess of Gallbladder", - "Acute Cholecystitis" - ], - "enrollment": "198.0", - "inclusion_criteria": "inclusion criteria: \n\n acutely inflamed gallbladder \n\n ", - "exclusion_criteria": ": \n\n chronic cholecystitis \n\n gallbladder polyp or gallbladder cancer \n\n the patient who underwent reduced port surgery \n\n the patient who underwent common bile duct exploration during the operation \n\n the patient who underwent concurrent operation \n\n the patient who had past history of upper abdominal surgery \n\n the patient who had a immunodeficiency state \n\n the case which had a suspicion of delayed bile leakage \n\n the case which had a incomplete cystic duct ligation \n\n the patient who underwent open conversion surgery during the operation \n\n the patient who had a high risk of bleeding", - "brief_summary": "During laparoscopic surgery for an acutely inflamed gallbladder, most surgeons routinely insert a drain. However, no consensus has been reached regarding the need for drainage in these cases, and the use of a drain remains controversial. This study is coordinated to find out the surgical outcomes and perioperative morbidity according to the insertion of drain after laparoscopic cholecystectomy. Investigators expect that the routine use of a drain after laparoscopic cholecystectomy for an acutely inflamed gallbladder will have no effects on the postoperative morbidity.", - "NCTID": "NCT02027402" - }, - { - "brief_title": "Assessment of Peritoneal Immune Response in Patients With Severe Intra-abdominal Sepsis Managed With Laparostomy and Vacuum Assisted Closure (VAC)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Abdominal Sepsis']", - "diseases_list": [ - "Abdominal Sepsis" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient > 18 years old \n\n 30 patients with severe abdominal sepsis in order to form the study group and 30 patients without sepsis undergoing major elective surgery (middle line incision >15cm) to form the control group. \n\n Patient or relatives signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures \n\n ", - "exclusion_criteria": ": \n\n Patient's Manheim Peritonitis Score < 29 \n\n Patient's pre-operative SOFA score < 6 \n\n The use of other temporary abdominal closure system \n\n Decease before the first VAC dressing change \n\n Patient is participating in another clinical trial which may affect this study's outcomes \n\n Patients with immune deficiency \n\n Documented seropositivity for human immunodeficiency virus (AIDS) \n\n Patient receiving steroids treatment for other medical condition \n\n Patient receiving chronic anti-inflammatory treatment \n\n Patient receiving anti- TNF treatment \n\n Pre-existing parechymal liver disease ( Cirrhosis - Child-Pugh C) \n\n Pregnancy", - "brief_summary": "Protocol Synopsis~Protocol title: Assessment of peritoneal immune response in patients with severe intra-abdominal sepsis managed by laparostomy and VAC~Purpose: Assessment of peritoneal immune response in patients with severe intra-abdominal sepsis~Design: Prospective, single-center study~Patient Population: Male or female adults (>18 years) with severe intra-abdominal sepsis~No. of Subjects: 60 patients divided into two groups, 30 patients with severe intra-operative sepsis and 30 patients without sepsis scheduled to undergo major abdominal operations (middle line incision>15cm). The study is estimated up to 2 year to enroll~Duration of Follow-up: Follow-up will be performed daily while hospitalized, until patient discharged or deceased.~Endpoints:~To measure the peritoneal cytokines levels in patients with severe intra-abdominal sepsis.~To correlate the cytokines levels in the abdominal cavity and the serum plasma.~To correlate cytokines response in serum plasma and peritoneal fluid with mortality and morbidity.~To compare cytokines results in serum plasma and peritoneal fluid between patients with severe intra-abdominal sepsis and patients undergoing major laparotomy without sepsis.~To assess the microbial load in the abdominal cavity in patients with severe sepsis.~To assess the biofilm formation in VAC polyurethane sponge.", - "NCTID": "NCT01410526" - }, - { - "brief_title": "Radiofrequency Ablation for Liver Abscesses From Chronic Granulomatous Disease", - "phase": "Phase 1", - "drugs": "['Cool-tip RF Ablation System']", - "drugs_list": [ - "Cool-tip RF Ablation System" - ], - "diseases": "['Chronic Granulomatous Diseases (CGD) and Liver Lesions']", - "diseases_list": [ - "Chronic Granulomatous Diseases (CGD) and Liver Lesions" - ], - "enrollment": "0.0", - "inclusion_criteria": "INCLUSION/ELIGIBILITY CRITERIA: \n\n A patient will be included if he or she meets all of the following criteria: \n\n Has documented chronic granulomatous disease \n\n Age 18 - 75 \n\n Has a liver abscess infected with Staphylococcus aureus or other microorganism susceptible to RFA, but is not an optimal candidate for curative surgical resection either due to location of disease, multiplicity of disease, or previous surgery or other comorbidities, such as pulmonary insufficiency, or has other contraindications to general anesthesia or perioperative management or refuses surgery. \n\n Is willing to return to NIH for imaging scans \n\n Is willing to undergo testing or procedures associated with this protocol \n\n Has failed long term antibiotic treatment and abscess drainage if applicable. \n\n ", - "exclusion_criteria": ": \n\n A patient will be excluded if he or she satisfies 1 or more of the following criteria: \n\n Positive results for toxin-producing bacteria obtained from liver biopsy in the pertinent abscess. \n\n Is a good candidate for liver-curative open surgical resection and does not refuse the surgery. \n\n Is not a candidate for RFA therapy due to lesion size or location. \n\n Has a prothrombin time (PT) or partial thromboplastin time (PTT) >1.5 times normal (except in patients who have a known lupus anticoagulant or other condition which a hematologist deems will not cause excessive bleeding despite the abnormal coagulation parameters). \n\n Has a platelet count <50,000/mm(3) which cannot be maintained despite platelet transfusions. \n\n If you are pregnant. \n\n Any condition that, in the investigator s opinion, places the patient at undue risk by participating in the study \n\n Please Note: Co-morbidities in critically ill patients will not themselves constitute ", - "brief_summary": "Background:~- Abscesses are a pocket of infection in an organ or tissue. Patients with a disease called chronic granulomatous disease (CGD) often develop these abscesses. CGD is an inherited disorder that affects how white blood cells function. Liver abscesses in people with CGD often require surgery to remove them and treat the infection. However, some people with CGD cannot have full surgery because it would be too risky. Researchers want to try a procedure called radiofrequency ablation (RFA) to treat these liver abscesses. RFA can usually be done without a major operation. This study will see if RFA is a safe and effective treatment for liver abscesses in patients with CGD.~Objectives:~- To see if RFA is a safe and effective treatment for CGD-related liver abscesses.~Eligibility:~- Individuals between 18 and 75 years of age with CGD who have liver abscesses that cannot be treated with surgery.~Design:~Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies will be performed on the liver.~Participants will have RFA for the abscesses. RFA is an image-guided technique that heats and destroys specific tissue, such as tumor tissue. It will target any abscesses on the liver.~After the procedure, participants will stay in the hospital for monitoring before being released.~Participants will have regular follow-up visits for up to 1 year after treatment. Blood and urine samples will be collected. Additional imaging studies will be performed.", - "NCTID": "NCT01851460" - }, - { - "brief_title": "Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy", - "phase": "", - "drugs": "['intra abdominal drain', 'LC without drain']", - "drugs_list": [ - "intra abdominal drain", - "LC without drain" - ], - "diseases": "['Abdominal Drainage', 'Laparoscopic Cholecystectomy', 'Gall Stones']", - "diseases_list": [ - "Abdominal Drainage", - "Laparoscopic Cholecystectomy", - "Gall Stones" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n patients with gallbladder stones and laparoscopic cholecystectomy \n\n ", - "exclusion_criteria": ": \n\n patients above 80 years old \n\n patients with acute cholecystitis \n\n patients with history of upper laparotomy \n\n patients with a hemorrhagic tendency due to cirrhosis \n\n patients refused to give informed consent and patients who were converted to open cholecystectomy", - "brief_summary": "Patients and methods: 100 patients were included in this study. They divided into two groups, group (A) with drain and group (B) without drain. The investigators recorded the effect of drainage on, postoperative pain (Po-P) using visual analogue scale VAS at 6, 24, 48 hours and 1 week postoperative nausea/vomiting at 6, 24, 48 hours postoperative, abdominal collection, hospital stay, chest complication, and postoperative body temperature.", - "NCTID": "NCT00886210" - }, - { - "brief_title": "Aspiration Treatment of Perianal Abscess", - "phase": "", - "drugs": "['MEDIPLAST\u00ae (aspiration)', 'incision', 'Clindamycin']", - "drugs_list": [ - "MEDIPLAST\u00ae (aspiration)", - "incision", - "Clindamycin" - ], - "diseases": "['Anal Fistulas']", - "diseases_list": [ - "Anal Fistulas" - ], - "enrollment": "111.0", - "inclusion_criteria": "inclusion criteria: \n\n \u226518 yrs old \n\n Perianal abscess (without spontaneous rupture) \n\n Abscess larger than 2 cm in diameter \n\n Signed informed consent \n\n ", - "exclusion_criteria": ": \n\n Malignancy within 5 yrs \n\n Previous radiotherapy of the abdomen and pelvis \n\n Recurrent abscess within 6 months \n\n Immune suppressed patients \n\n Pregnant and lactating women \n\n Abscess with horseshoe formation \n\n Allergy to Clindamycin", - "brief_summary": "The purpose of this study is to compare aspiration and oral antibiotics with surgical incision in the treatment of perianal abscesses in terms of recurrence and subsequent fistula formation. Included patients will be randomised to either aspiration or incision.", - "NCTID": "NCT02585141" - }, - { - "brief_title": "Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease", - "phase": "Phase 2; Phase 3", - "drugs": "['Lanreotide Autogel 90 mg and 120 mg']", - "drugs_list": [ - "Lanreotide Autogel 90 mg and 120 mg" - ], - "diseases": "['Polycystic Liver Disease']", - "diseases_list": [ - "Polycystic Liver Disease" - ], - "enrollment": "59.0", - "inclusion_criteria": "inclusion criteria: \n\n Liver volume \u2265 4 liter \n\n \u2265 20 liver cysts \n\n Symptomatic patients defined as at least 2 out of 5 of the following symptoms related to mass effect irrespective of the intensity: \n\n Abdominal distention perceived as uncomfortable \n\n Frequent abdominal pain \n\n Early satiety \n\n Nausea (with the inclusion of dyspeptic complaints) \n\n Dyspnea \n\n Diagnosed with ADPKD or ADPLD \n\n Male and female patients of 18 years and older \n\n Written informed consent \n\n ", - "exclusion_criteria": ": \n\n Creatinine clearance < 20 ml/min \n\n Patient who underwent a kidney transplant and received variable doses of immunosuppressive therapy and/or present signs of rejection in the past year \n\n Hormonal replacement therapy \n\n Hormonal contraception \n\n Pregnant or lactating \n\n Presenting with an uncontrolled disease (other than ADPKD/ADPLD) \n\n Planned to undergo any surgery of the liver during study participation \n\n Planned to undergo any surgery of the KIDNEY during study participation (ADPKD patients only) \n\n Patients with known allergies to somatostatin or its analogues or any of its components \n\n Patients who received somatostatin analogues in the 6 months preceding study inclusion", - "brief_summary": "An open-label, Phase II clinical study to evaluate the efficacy and safety of lanreotide autogel 90mg every 4 weeks in the treatment of symptomatic polycystic liver disease, including a dose escalation at month 6 to lanreotide autogel 120mg for non responders.", - "NCTID": "NCT01315795" - }, - { - "brief_title": "Perforated Appendicitis With Delayed Presentation", - "phase": "", - "drugs": "['Laparoscopic or open appendectomy', 'Expectant Management']", - "drugs_list": [ - "Laparoscopic or open appendectomy", - "Expectant Management" - ], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "5.0", - "inclusion_criteria": "inclusion criteria: \n\n All children with a delayed diagnosis of perforated appendicitis. Delayed diagnosis will be defined as symptoms for 4 or more days. Duration of symptoms will be defined as the time pain started. \n\n Confirmed diagnosis of perforated appendicitis. The diagnosis of perforated appendicitis will be based on diagnostic imaging (CT scan or ultrasound), showing an established appendiceal abscess or phlegmon. \n\n Consent to participate \n\n ", - "exclusion_criteria": ": \n\n Uncertainty about the diagnosis. \n\n The need for laparotomy for another reason. \n\n Free intraperitoneal air on imaging. \n\n Perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis. \n\n Children with other medical condition that may affect the decision to operate e.g: children with inflammatory bowel disease.", - "brief_summary": "There is no consensus among pediatric surgeons regarding the optimal treatment for children with complicated appendicitis with delayed diagnosis. With the development of broad-spectrum antibiotics, some surgeons have advocated expectant management for these children. However, there is little evidence to determine which children are most likely to benefit from this approach. Prior attempts to determine the effectiveness of expectant management for perforated appendicitis with delayed diagnosis often have not controlled for inherent differences in the clinical status of patients treated non-operatively vs. those treated with immediate appendectomy.", - "NCTID": "NCT01068288" - }, - { - "brief_title": "Correlation of Location of Abdominal Tenderness With Acute CT Abnormalities in Emergency Department Patients", - "phase": "", - "drugs": "['radio-opaque adhesive skin markers']", - "drugs_list": [ - "radio-opaque adhesive skin markers" - ], - "diseases": "['Abdominal Pain']", - "diseases_list": [ - "Abdominal Pain" - ], - "enrollment": "102.0", - "inclusion_criteria": "inclusion criteria: \n\n All consecutive emergency department patients undergoing abdominal CT for non-traumatic abdominal pain and tenderness will be prospectively enrolled, with the following exceptions. For study purposes, abdominal pain and tenderness is defined as pain and tenderness to direct palpation in the region anterior to the mid-axillary line bilaterally, and extending from the costal margins to the inguinal ligaments. Consequently, patients undergoing CT for indications such as isolated vomiting, fever without source, staging of malignancies, isolated flank pain or suspected renal colic, or other indications that do not meet the above definition will not be enrolled. \n\n ", - "exclusion_criteria": ": \n\n Pregnant women do not routinely undergo abdominal CT due to radiation concerns and will be excluded from the study. \n\n Patients with altered mental status or altered abdominal sensation (due to neurological conditions such as paraplegia) that may prevent assessment of the location of abdominal tenderness will be excluded. \n\n Preverbal children will be excluded as they rarely undergo CT and will be unable to indicate the region of maximal tenderness.", - "brief_summary": "To determine the correlation between the region of abdominal tenderness determined by the examining physician and the location of acute pathology diagnosed on abdominal CT. We hypothesize that the acute pathology diagnosed by CT will lie within the region marked on the abdominal wall by the examining physician prior to CT.", - "NCTID": "NCT00673374" - }, - { - "brief_title": "Early Versus Interval Appendectomy for Ruptured Appendicitis in Children", - "phase": "Phase 3", - "drugs": "['early appendectomy', 'interval appendectomy']", - "drugs_list": [ - "early appendectomy", - "interval appendectomy" - ], - "diseases": "['Ruptured Appendicitis']", - "diseases_list": [ - "Ruptured Appendicitis" - ], - "enrollment": "128.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of ruptured appendicitis \n\n ", - "exclusion_criteria": ": \n\n Inability to have usual follow up care (e.g. transient to area)", - "brief_summary": "The purpose of this randomized trial is to compare two commonly utilized surgical treatments for children with ruptured appendicitis: early appendectomy, versus interval appendectomy. The primary outcome measure is time away from normal activities.", - "NCTID": "NCT00435032" - }, - { - "brief_title": "Efficacy and Safety of Primovist in Chinese Patients", - "phase": "Phase 3", - "drugs": "['Gadoxetic Acid Disodium (Primovist, BAY86-4873)']", - "drugs_list": [ - "Gadoxetic Acid Disodium (Primovist", - "BAY86-4873)" - ], - "diseases": "['Known or Suspected Focal Liver Lesions']", - "diseases_list": [ - "Known or Suspected Focal Liver Lesions" - ], - "enrollment": "234.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients between 18 and 75 years of age inclusive. \n\n Patients (men or women) with at least one focal liver lesion, either identified or suspected by ultrasound (US), Computed Tomography (CT)/spiral-CT, conventional angiography, CT-angiography (CTA), CT-arterioportography (CTAP) or unenhanced / contrast-enhanced MRI* within 2 months before entering the study \n\n For reference, the following pathologies will meet the definition of 'focal liver lesions': \n\n Hepatocellular carcinoma \n\n Cholangiole carcinoma \n\n Metastasis \n\n Focal lymphoma \n\n Adenoma \n\n Focal nodular hyperplasia \n\n Hemangioma \n\n Abscess \n\n Focal liver fibrosis \n\n Regenerative nodules \n\n Focal fatty infiltration \n\n Hydatid cyst \n\n Liver cyst \n\n Focal sparing in fatty liver \n\n Others \n\n Patients willing to undergo study procedures including safety follow-up \n\n Patients who have undergone or who are scheduled to undergo the defined procedure for SOR within one month before or after the study MRI \n\n Women of child-bearing potential with negative urine pregnancy test result within 24 hours before contrast medium (CM) injection \n\n Patients who are fully informed about the study and have signed the informed consent form \n\n ", - "exclusion_criteria": ": \n\n Patients who have previously entered this study \n\n Patients who have received any contrast material within 24 hours before injection with study drug, or who are scheduled to receive any contrast material within 24 hours after injection \n\n Patients who are, or suspected to be, nursing \n\n Patients who require emergency treatment \n\n Patients with severely impaired hepatic or renal functions (e.g. serum glutamic-pyruvic transaminase (SGPT) twice the upper limit of reference range, acute renal failure) \n\n Patients who are clinically unstable and whose clinical course during the observation period is unpredictable (e.g. due to previous surgery, acute myocardial infarction) \n\n Patients with any physical or mental status that interferes with the signing of informed consent \n\n Patients with known anaphylactoid or anaphylactic reaction to any contrast media or hypersensitivity to any allergen including drugs \n\n Patients with a contraindication for MRI \n\n Patients who are scheduled for liver biopsy/surgery or other surgeries within 24 hours after injection with contrast media, or who would have a biopsy within 24 hours before planned injection with contrast media \n\n Patients who are likely to have any therapy or change in therapy between the study MRI and the procedures for the SOR", - "brief_summary": "Participants who had been diagnosed or suspected by doctors to have focal liver lesions that need further evaluation in order to make an accurate diagnosis. Participants would need to have an enhanced magnetic resonance imaging (MRI) scan so that doctors could have further information about the number and characteristics of the focal liver lesions.~Participants were invited to take part in this clinical study. The purpose of this study was to evaluate Primovist, which is a liver-specific MRI contrast medium, on the efficacy of lesion detection and characterization, and tolerability in Chinese patients with known or suspected focal liver lesions.~Primovist, the investigational drug in this study, is a liver-specific MRI contrast medium developed by Bayer Schering Pharma AG. Its active substance is Gd-EOB-DTPA. Primovist was first approved in 2004 in Sweden followed by an approval in the European community, in Switzerland and Australia in the same year.~Procedures:~Before entry into the study and after entry of the study a physical examination was conducted, blood pressure and heart rate were measured, blood and urine samples were taken. Current medications and medical conditions (including suspected pregnancy) and medical and surgical history were elicited by doctors.~After entry into the study, participants were scheduled to have an MRI examination, which lasted about 25-35 minutes.~During the MRI examination, an initial MRI scan without contrast was acquired which followed by another MRI series after the intravenous administration of Primovist.~The following day participants were asked to return to the hospital for a follow-up safety evaluation.~Possible Benefit Participants were scheduled to receive an enhanced magnetic resonance imaging scan. Clinical studies indicated that Primovist increased the efficacy of detection and characterization of focal liver lesions by providing better contrast between the focal liver lesions and surrounding normal tissue. Primovist were shown to provide additional information regarding existence, number and characterization (lesion or non-lesion, malignant or benign) of these abnormalities.~Based on the experience with patients given Primovist, some adverse reactions were observed.~Most of undesirable effects were transient and of mild to moderate intensity. The most commonly noted adverse events (AEs) in subjects receiving Primovist for MRI were nausea and headache with an incidence of 1.1%. Other AEs that occurred in 0.5% of the subject population were feeling hot (0.8%), back pain (0.6%) and dizziness (0.5%).~All other AEs occurred in less than 0.5% of the patients, e.g. anxiety; coughing; eye disorder; fever; flatulence; generalized spasm; hypertension; injection site symptoms including edema, inflammation, and reaction; lightheadedness; parosmia; postural hypotension; taste perversion, motoric unrest; acute respiratory distress; fatigue; malaise; vomiting; palpitations, erythema, chest pain and back pain.~Coldness, warmth or pain at the injection site, injection site reaction, and injection site accumulation of fluid were rare. In very rare cases strong allergy-like reactions ranging to shock may occur.~Post-marketing tachycardia and restlessness have been reported. As in the case of other investigational drugs, there may also be unforeseen side effects.~Additional information concerning all Gadolinium- based contrast agents Primovist contains the rare earth metal gadolinium as active ingredient. There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents (especially Omniscan) in patients with severe renal impairment. NSF is a systemic disease characterised by formation of connective tissue in the skin, which becomes thickened and hard, sometimes leading to contractures and joint immobility. The clinical course is usually progressive and currently no treatment is available. To date NSF has only been reported in association with some Gd-containing contrast agents, but the role of these contrast agents in the overall pathogenesis of the disease is still not completely understood.~No reports of patients with NSF after administration of Primovist\u00ae are known. The risk to trigger NSF in risk patients with severe renal impairment is considered to be low for Primovist\u00ae due to the low dose given and the additional excretion via feces. Furthermore the participation of patients with severe renal impairment are excluded from this study.~In case the participants were suffering from renal insufficiency, they were told to tell their doctors prior to application of the contrast agent. In case the participants experienced any new alterations of the skin following the administration of the contrast agent, they were told to contact their doctors as soon as possible after they had recognized these symptoms.", - "NCTID": "NCT00526188" - }, - { - "brief_title": "Contrast Enhanced Ultrasound For The Evaluation Of Focal Liver Lesions", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Focal Nodular Hyperplasia of Liver', 'Toxic Liver Disease With Focal Nodular Hyperplasia', 'Liver Metastases']", - "diseases_list": [ - "Focal Nodular Hyperplasia of Liver", - "Toxic Liver Disease With Focal Nodular Hyperplasia", - "Liver Metastases" - ], - "enrollment": "1500.0", - "inclusion_criteria": "inclusion criteria: \n\n patients diagnosed with de novo FLL at standard ultrasound \n\n age > 18 years, male and female gender \n\n informed consent for the contrast enhanced study \n\n ", - "exclusion_criteria": ": \n\n patients with contraindication for contrast enhanced study: subjects with acute cardiac infarction, with class III/IV cardiac insufficiency, with rhythm disorders and pregnant women \n\n Patients diagnosed with simple cysts at standard ultrasound (biliary of hydatid) \n\n Patients with known FLL, for example after percutaneous treatment, in which the contrast study is used for the follow up of the patient.", - "brief_summary": "The aim of the study is to assess the value of contrast enhanced ultrasound in the evaluation of de novo focal liver lesions in clinical practice, in a prospective multi-center design.", - "NCTID": "NCT01329458" - }, - { - "brief_title": "Study on Laparoscopic Operation for Perforated Appendicitis", - "phase": "", - "drugs": "['Laparoscopic appendectomy', 'Open appendectomy']", - "drugs_list": [ - "Laparoscopic appendectomy", - "Open appendectomy" - ], - "diseases": "['Perforated Appendicitis']", - "diseases_list": [ - "Perforated Appendicitis" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients admitted at the emergency station of our hospital expressing pain other than the right lower abdominal quadrant. \n\n The results of a clinical examination favored the diagnosis of perforated acute appendicitis, and the result of abdominal computed tomography revealed signs of acute appendicitis and intra-abdominal fluid accumulation. \n\n Patients were accepted to our study only if perforated appendicitis remained as the most likely diagnosis of their condition and if they were between 12 from 80 years old with informed consent. \n\n ", - "exclusion_criteria": ": \n\n Age less than 12 years \n\n older than 80 years \n\n perforated appendicitis was not revealed by pathologic investigation \n\n diverticulitis being diagnosed during surgery \n\n pelvic inflammatory disease or other gynecologic disease found during laparoscopic examination or diagnosed before operation \n\n the patient declining to enroll in this study", - "brief_summary": "The purpose of this study is to conduct a prospective observational study for the open approach and laparoscopic approach for perforated appendicitis. It is also designed to investigate if carbon dioxide pneumoperitoneum will have unwanted effect when treating perforated appendicitis with laparoscopic operation.", - "NCTID": "NCT00677989" - }, - { - "brief_title": "Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection", - "phase": "", - "drugs": "['Azithromycin and standard of care', 'Placebo and standard of care']", - "drugs_list": [ - "Azithromycin and standard of care", - "Placebo and standard of care" - ], - "diseases": "['Endometritis', 'Wound Infection', 'Abscess', 'Surgical Site Infection']", - "diseases_list": [ - "Endometritis", - "Wound Infection", - "Abscess", - "Surgical Site Infection" - ], - "enrollment": "2013.0", - "inclusion_criteria": "inclusion criteria: \n\n - \n\n Pregnant Women aged 14 years and over at \u2265 24 weeks' viable gestation who will undergo unscheduled/non-elective cesareans with either: \n\n Labor (spontaneous or induced): active labor (ongoing contractions and at least 4cm dilated or contractions for at least 4 hours with documented cervical change of \u22651cm dilatation or \u226550% effacement), or \n\n Membrane rupture (standardized to duration of at least 4 hours prior to randomization). \n\n ", - "exclusion_criteria": ": \n\n Patient unwilling or unable to provide consent \n\n Multiple pregnancy \n\n Known azithromycin (or other macrolide) allergy \n\n Vaginal delivery \n\n Elective or scheduled cesarean prior to labor or membrane rupture. \n\n Azithromycin, erythromycin or other macrolide antibiotic use within 7 days of enrollment. \n\n Clinical chorioamnionitis or any other active bacterial infection (e.g. pyelonephritis, pneumonia, abscess) at time of randomization. \n\n Patient is unable or unlikely to follow-up after delivery (e.g. no prenatal care or a non-resident patient) \n\n Fetal demise or major congenital anomaly \n\n Significant liver disease defined as known cirrhosis or elevated transaminases of at least 3-fold upper limit of normal \n\n Significant renal disease defined as serum creatinine known to be >2.0 mg/dl or on dialysis. \n\n Active congestive heart failure (EF<45%) or pulmonary edema \n\n Active diarrhea at time of delivery \n\n Any patient with significant electrolyte abnormalities such as hypokalemia or hypocalcemia \n\n Any patient with structural heart disease or arrhythmias, or taking any medications known to prolong the QT interval \n\n Patient currently being treated with efavirenz, nelfinavir or fluconazole", - "brief_summary": "The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) study is a large pragmatic multi-center randomized clinical trial designed to evaluate the comparative effectiveness and safety of azithromycin-based extended-spectrum antibiotic prophylaxis (azithromycin plus standard narrow-spectrum cephalosporin) relative to standard single-agent cephalosporin (preferably prior to surgical incision) to prevent post-cesarean infection.~Hypothesis: Compared to narrow-spectrum prophylaxis (i.e. cefazolin alone, or clindamycin if cephalosporin allergy) prior to surgical incision, the addition of extended-spectrum prophylaxis (azithromycin + cefazolin) reduces the incidence of post-cesarean infection.", - "NCTID": "NCT01235546" - }, - { - "brief_title": "Adult Dengue Platelet Study", - "phase": "", - "drugs": "['Platelet transfusion', 'Supportive care']", - "drugs_list": [ - "Platelet transfusion", - "Supportive care" - ], - "diseases": "['Dengue Fever']", - "diseases_list": [ - "Dengue Fever" - ], - "enrollment": "372.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 21years \n\n Probable or confirmed dengue \n\n a) Confirmed dengue: laboratory confirmation of acute dengue by either i) positive polymerase chain reaction (PCR) for viral ribonucleic acid (RNA), or ii)positive NS1 antigen test with a compatible clinical syndrome b) Probable dengue: Positive acute dengue serology and clinical presentation fulfilling either WHO 1997 or 2009 criteria for probable dengue. \n\n i) 1997 criteria: Acute febrile illness and two or more of the following: \n\n headache, \n\n retro-orbital pain, \n\n myalgia, \n\n arthralgia, \n\n rash, \n\n hemorrhagic manifestations, \n\n leucopoenia ii) 2009 criteria: Fever and two of the following: \n\n nausea/vomiting, \n\n rash, \n\n aches/pains, \n\n positive tourniquet test, \n\n leucopoenia, \n\n one or more warning sign \n\n abdominal pain/tenderness, \n\n persistent vomiting, \n\n clinical fluid accumulation, \n\n mucosal bleed, \n\n lethargy/restlessness, \n\n liver enlargement >2cm, \n\n increase in haematocrit concurrent with rapid decrease in platelet count \n\n Platelets \u2264 20x103/\u03bcL", - "exclusion_criteria": "", - "brief_summary": "Retrospective data in children with dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS), and in adults with dengue fever (DF), suggested a lack of benefit from prophylactic platelet transfusion for severe thrombocytopenia in dengue patients without bleeding. However, in Taiwan and Singapore, platelet transfusion was given to 13-50% of hospitalised dengue patients. This is a prospective randomised study to examine the safety and efficacy of prophylactic platelet transfusion in adults with dengue and severe thrombocytopenia without bleeding.~The hypotheses are:~Prophylactic platelet transfusion is safe in hospitalised dengue patients with severe thrombocytopenia.~Prophylactic platelet transfusion is effective in preventing bleeding in hospitalised dengue patients with severe thrombocytopenia.", - "NCTID": "NCT01030211" - }, - { - "brief_title": "Intra-hepatic Artery Bone Marrow Derived Stem Cells Infusion for the Treatment of Advanced Liver Cirrhosis", - "phase": "Phase 1; Phase 2", - "drugs": "['Stem cell transplant']", - "drugs_list": [ - "Stem cell transplant" - ], - "diseases": "['End Stage Liver Disease']", - "diseases_list": [ - "End Stage Liver Disease" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Age >18 years \n\n Clinically diagnosed liver cirrhosis by any of the following: ultrasound/MRI/ CT/ + tissue biopsy. \n\n MELD score \u2265 18 and <35 \n\n Ability to sign an informed consent \n\n Refused by liver transplant program or labeled as not a liver transplant candidate, decided by at least 3 transplant physicians \n\n ", - "exclusion_criteria": ": \n\n On a liver transplantation waiting list \n\n Questionable diagnosis of cirrhosis \n\n Prior history of organ transplantation \n\n Past history of malignancy within the 2 years prior to inclusion \n\n Probable or diagnosis of hepatocellular carcinoma \n\n Major hepatic vascular thrombosis (hepatic artery, or portal or hepatic veins) \n\n Serious cardiovascular or respiratory disease, or other medical condition with a high anticipated mortality within twelve months \n\n Current or recent (within the past 4 weeks) use of vasoactive drugs (Epinephrine, Norepinephrine, Vasopressin, Dopamine, terlipressin) \n\n Type-1 (acute) hepatorenal syndrome \n\n Levels of serum creatinine >150 \u00b5mol/ml and/or creatinine clearance <30 ml/min (as calculated by MDRD system) \n\n Documented or suspected ongoing infection \n\n Active or recent gastrointestinal bleeding episode (in the previous 4 weeks) \n\n Active alcohol abuse extending to within the previous six months \n\n Pulmonary hypertension (PAP > 35 mmHg), porto-pulmonary hypertension or hepatopulmonary syndrome \n\n Pregnancy \n\n HIV infection \n\n Active or past drug addiction within the preceding 6 months \n\n History of serious or uncontrolled psychiatric disease or depression \n\n Contraindications to the angiography procedures (e.g. arterial aneurysm, kinking, thrombosis) \n\n Contraindications for bone marrow biopsy (e.g. bleeding diathesis) \n\n Prior shunt operative shunt procedure", - "brief_summary": "Liver disease is a common medical problem in Saudi Arabia. Early studies indicated that around 10% of the Saudi population is either infected with hepatitis B or C. An estimated 12% of chronic HCV and HBV patients undergoing liver biopsy from Saudi centers have cirrhosis. Of these 3-5% would decompensate yearly thereby requiring liver transplantation. Based on the most recent national census figures, and a 1-2% prevalence rate of HBV and HCV nationwide, an estimated 1,000 patients would require liver transplantation on a yearly basis for decompensated cirrhosis.~Liver transplantation is the only available life saving treatment for patients with end stage liver disease. Unfortunately less than 100 liver transplantations are performed in Saudi Arabia in three centers. Around 100 other patients travel abroad for transplantation annually while all other patients progressively deteriorate and eventually die from the complications of decompensated liver cirrhosis.~In addition, even in patients who are listed for liver transplantation, often patients are too sick to wait on the transplant list that often takes more than a year and the on-list mortality is high. A procedure or an intervention that may help to stabilize liver function in order to help patients survive on the transplant list while awaiting liver transplantation would be of immense benefit. Examples of such interventions are already approved and used in some centers like the MARS system.", - "NCTID": "NCT01412593" - }, - { - "brief_title": "Efficacy of Combining Pasireotide With Aspiration Sclerotherapy to Improve Volume Reduction of Hepatic Cysts", - "phase": "Phase 3", - "drugs": "['Pasireotide LAR 60 mg', 'Aspiration sclerotherapy', 'Placebo']", - "drugs_list": [ - "Pasireotide LAR 60 mg", - "Aspiration sclerotherapy", - "Placebo" - ], - "diseases": "['Symptomatic Dominant Liver Cyst']", - "diseases_list": [ - "Symptomatic Dominant Liver Cyst" - ], - "enrollment": "34.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients who are diagnosed with a dominant liver cyst with an indication for aspiration and sclerotherapy are suitable for inclusion in this study. \n\n In order to be eligible to participate in this study, a subject must meet all of the following criteria: \n\n Age 18 - 70 years \n\n Indication for aspiration and sclerotherapy \n\n Providing informed consent \n\n ", - "exclusion_criteria": ": \n\n A potential subject who meets any of the following criteria will be excluded from participation in this study \n\n ASPIRATION SCLEROTHERAPY RELATED ", - "brief_summary": "Liver cysts are fluid filled cavities located in the liver. They are present in 2-11% of the general population, typically not causing any symptoms or complications. However, in a small subset of patients complaints of pain, abdominal fullness and distension, dyspnea and nausea occur.~Currently, aspiration and sclerotherapy is a treatment of choice in symptomatic patients with a large dominant liver cyst. However, studies reported early fluid reaccumulation and relative high recurrence rates of cyst growth after aspiration sclerotherapy ultimately leading to re-interventions. In this respect, somatostatin analogues are promising agents known for its volume reducing effect in patients with polycystic liver disease.~In this study the investigators want to evaluate the effect of combining aspiration sclerotherapy with the multi-receptor binding, long-acting somatostatin analogue Pasireotide.~The investigators hypothesize that administrating pasireotide before and after aspiration sclerotherapy could prevent early fluid reaccumulation and thereby result in a greater reduction of cyst diameter. Moreover, the investigators expect a lower rate of cyst recurrence and subsequently lower need for re-interventions.", - "NCTID": "NCT02048319" - }, - { - "brief_title": "Post-Market Clinical Follow-Up Study to Confirm Clinical Performance and Safety of the Codman Enterprise\u00ae 2 Vascular Reconstruction Device in the Endovascular Treatment of Intracranial Aneurysms", - "phase": "", - "drugs": "['Enterprise 2 Vascular Reconstruction Device']", - "drugs_list": [ - "Enterprise 2 Vascular Reconstruction Device" - ], - "diseases": "['Intracranial Aneurysm']", - "diseases_list": [ - "Intracranial Aneurysm" - ], - "enrollment": "26.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject \u2265 18 years old. \n\n Subjects with non-ruptured or ruptured intracranial aneurysm that is referred for endovascular treatment. \n\n Parent vessel with a diameter of \u2265 2.0 mm and \u2264 4 mm. \n\n Subject understands the nature of the procedure and provides voluntary written informed consent in accordance with the requirements of this study protocol. \n\n Subject is willing to participate in the telephone follow-ups and to return to the investigational site for the post-procedure follow-up evaluations. \n\n ", - "exclusion_criteria": ": \n\n Angiogram demonstrating that the aneurysm is not appropriate for endovascular treatment (i.e.: severe intracranial vessel tortuosity, stenosis, intracranial vasospasm not responsive to medical therapy). \n\n Mycotic or traumatic aneurysm. \n\n Arteriovenous malformation (AVM) in the territory of the target aneurysm. \n\n Two or more aneurysms (>2mm) in associated distribution. \n\n Hunt and Hess Scale (HHS) of IV or V at inclusion for subject with ruptured aneurysms. \n\n Life expectancy of less than 6 months as determined by the treating physician. \n\n A planned staged procedure (i.e. a procedure where entire treatment with the devices (e.g. coils/stents) is completed over separate sessions). \n\n Previous neuro-interventional or neuro-surgical procedure of any kind within 30 days prior to the study procedure. \n\n Intracranial mass (tumor, abscess, or other infection), or undergoing radiation therapy for carcinoma or sarcoma of the head or neck region. \n\n Unsuitable for the antithrombotic and/or anticoagulant therapies \n\n Serum creatinine level > 2.5 mg/dl within 7 days prior to index procedure \n\n Known hypersensitivity or allergies to cobalt, nitinol metal, nickel, or sensitivity to contrast media, \n\n Evidence of an acute myocardial infarction (MI) within 30 days prior to the index procedure. \n\n Uncontrolled atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms. \n\n Subject is pregnant", - "brief_summary": "The objective of this Post-Market Clinical Follow-up (PMCF) is to confirm the performance and safety of the Codman Enterprise\u00ae 2 when used in conjunction with endovascular coil embolization of ruptured or non-ruptured intracranial aneurysms.", - "NCTID": "NCT02415010" - }, - { - "brief_title": "Microwave Ablation and Partial Splenic Embolization in the Management of Hypersplenism", - "phase": "", - "drugs": "['Microwave Thermal Coagulation', 'Partial Splenic Embolization']", - "drugs_list": [ - "Microwave Thermal Coagulation", - "Partial Splenic Embolization" - ], - "diseases": "['Hypersplenism']", - "diseases_list": [ - "Hypersplenism" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Liver Cirrhosis \n\n Hypersplenism \n\n ", - "exclusion_criteria": ": \n\n Patients with bad performance scale. \n\n Patients with hepatic encephalopathy and tense ascites. \n\n Patient with active esophageal variceal bleeding . \n\n Patients with hypocellular bone marrow (BM). \n\n Patients with renal failure.", - "brief_summary": "The aim of this study is to compare microwave thermal coagulation and partial splenic embolization in the management of hypersplenism in patients with cirrhosis.~This study will be conducted on 40 patients with liver cirrhosis associated with splenomegaly and hypersplenism. The study will be done at the National Hepatology and Tropical Medicine Research Institute.", - "NCTID": "NCT02261584" - }, - { - "brief_title": "Once-daily Therapy for Streptococcal Pharyngitis", - "phase": "Phase 1", - "drugs": "['Amoxicillin', 'Intramuscular Benzathin Penicillin G']", - "drugs_list": [ - "Amoxicillin", - "Intramuscular Benzathin Penicillin G" - ], - "diseases": "['Streptococcal Sore Throat']", - "diseases_list": [ - "Streptococcal Sore Throat" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n inclusion criteria: \n\n Age of 6 to 15 years old. \n\n The criteria in clinical examination including objective signs (fever, Erythema or exudate of tonsils, enlarged lymph nodes) and subjective sign(sore throat). Neck tenderness, abdominal pain and pharynx petechia were also considered. \n\n No antibiotic was used during the week before. \n\n -Performing throat culture before the initiation of drug administration \n\n Positive throat culture indication GABHS \n\n No previous history of allergy to penicillin . \n\n ", - "exclusion_criteria": ": \n\n Age of below 6 years old or above 15 years old. \n\n No signs of pharyngitis in the clinical examination \n\n Antibiotic use during the week before. \n\n Throat culture was not performed before the initiation of drug administration. \n\n Negative throat culture or the culture indicates a microorganism other than GABHS. \n\n History of allergy to penicillin \n\n Not using drugs or not following the treatment in the field of having the second culture performed.", - "brief_summary": "In some studies once daily amoxicillin therapy might be treatment of choice for Group A \u03b2-hemolytic Streptococcus pharyngitis in comparison with three to four times daily treatment with oral penicillin V.", - "NCTID": "NCT01310361" - }, - { - "brief_title": "Intraperitoneal Local Anaesthetic in Colonic Surgery", - "phase": "Phase 1", - "drugs": "['Ropivacaine', '0.9% Saline']", - "drugs_list": [ - "Ropivacaine", - "0.9% Saline" - ], - "diseases": "['Colon Surgery']", - "diseases_list": [ - "Colon Surgery" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Consecutive patients undergoing open colonic resection at MSC under the ERAS program. \n\n ", - "exclusion_criteria": ": \n\n Known sensitivity to the local anaesthetic agents \n\n Patients who prefer not to participate (no consent gained) \n\n ASA greater or equal to 4 \n\n Rectal resection \n\n Formation of stoma \n\n Current use of systemic steroids", - "brief_summary": "Aim:~The general aim of this research group is to improve the recovery of patients after abdominal surgery. The specific aim of this study is to conduct a randomized, double blinded, controlled trial to investigate the effect of intra-peritoneal local anaesthesia application on postoperative pain and post-operative fatigue. This will be conducted in the setting of an enhanced recovery after surgery program (ERAS).~Methods:~Patients will be randomised by computer generated random numbers and opaque envelope method. In the treatment arm patients will receive 10ml 0.75% ropivacaine diluted to 50mls with 0.9% saline soon after the creation of the laparotomy . In the placebo arm, 50mls of 0.9% normal saline will be used in a similar fashion. At closure, two small 2mm catheter belonging to the On-Q pain buster system will be placed in the peritoneal cavity. This will be attached to a pump which will contain either a 0.2% ropivacaine solution or 0.9% saline placebo running at 4mls/hr for 68 hours. All members involved in patient care (with the exception of one nurse) will be blinded to the above. After 68 hours the pump will be stopped and the catheter will be removed. Assessment of postoperative pain will be performed by visual analogue scale, and fatigue assessment will be done using the Identity Consequence Fatigue Scale (ICFS) at various intervals post-operatively. Blood tests for inflammatory markers including glucose, cortisol, CRP, albumin and several cytokines as well as local anaesthetic levels will be taken.~Significance to health:~This method of analgesia administration has not been investigated in open major colonic surgery. This trial has wide reaching implications, with the potential to improve pain and thus recovery after abdominal surgery.", - "NCTID": "NCT00722709" - }, - { - "brief_title": "A Minimally-invasive Approach to Cytoreduction and HIPEC for Peritoneal Surface Malignancy", - "phase": "Phase 2", - "drugs": "['Minimally-Invasive Procedure']", - "drugs_list": [ - "Minimally-Invasive Procedure" - ], - "diseases": "['Cancer']", - "diseases_list": [ - "Cancer" - ], - "enrollment": "18.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged > 18 years old \n\n Capable of providing informed consent. \n\n Histologically confirmed peritoneal carcinomatosis from appendiceal, colorectal, ovarian, or primary mesothelioma, with no systemic metastases. \n\n Evidence of low-volume peritoneal disease defined by a PCI < 10 based on cross-sectional imaging / and / or diagnostic laparoscopy findings. \n\n Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status of 0-2. \n\n Patients who are medically fit for surgery defined as the following: \n\n No parenchymal hepatic metastases \n\n No evidence of clinical (jaundice), biochemical (abnormally elevated serum bilirubin and/or alkaline phosphatase) or radiological (ultrasound, CT, or MR) biliary obstruction \n\n No cross sectional imaging findings indicative of multi-segmental (>1 site) small bowel obstruction, or small bowel loops matted together, or gross disease of the small bowel mesentery characterized by distortion, thickening or loss of mesenteric vascular clarity \n\n No clinical or radiological evidence of hematogenous or distant nodal (retroperitoneal, pelvic, mediastinal, peri-portal or peri-aortic) metastasis \n\n Absolute neutrophil count (ANC) > 1200/mm3, white blood cell count (WBC) > 4000/mm3 and platelet count > 150,000/mm3 \n\n An international normalized ratio (INR) \u2264 1.5 (patients who are therapeutically anticoagulated for unrelated medical conditions such as atrial fibrillation and whose antithrombotic treatment can be withheld for operation will be eligible). \n\n Adequate hepatic function must be met as evidenced by total serum bilirubin \u2264 1.5 mg/dl (patients with total bilirubin > 1.5 mg/dL eligible only with Gilbert's syndrome); \n\n Alkaline phosphatase < 2.5 times the upper limit of normal; and/or \n\n Aspartate transaminase (AST) < 1.5 times upper limit of normal (alkaline phosphatase and AST cannot both exceed the upper limit of normal) \n\n Serum renal functional parameters, blood urea nitrogen (BUN) and creatinine are within normal limits \n\n Satisfactory cardiopulmonary function (no history of severe congestive heart failure or severe pulmonary disease, as indicated by clinically acceptable risks to undergo major abdominal - cytoreductive surgery). \n\n No clinical history of acute myocardial infarction within six months of registration. \n\n Patients who are status post revascularization procedures with satisfactory cardiac function are eligible. \n\n No significant history of a medical problem or co-morbidity that would preclude the patient from undergoing a major abdominal operation such as a history of severe congestive heart failure or active ischemic heart disease. \n\n No concurrent second malignancy requiring systemic therapy. \n\n No psychiatric or addictive disorders or other conditions that would preclude the patient from meeting the study requirements. \n\n ", - "exclusion_criteria": ": \n\n Peritoneal carcinomatosis index (PCI) > 10 \n\n Systemic (extraperitoneal) disease, pregnant, incarcerated. \n\n Pregnant and lactating women. Women of reproductive age must be willing to use contraception during study therapy.", - "brief_summary": "The purpose of this study is to determine the feasibility of surgical techniques involving minimal entry into the living body approach for tumor reduction and treatment in which highly concentrated anticancer drugs are put directly into the abdomen through a tubes (HIPEC), and to determine if this approach may improve short-term postoperative outcomes, including the development of complications related to surgery within the first 30 days after surgery.~Participation in this study is entirely voluntary. Approximately 30 subjects will take part in this single-center study and all will be enrolled at University of California San Diego.", - "NCTID": "NCT02463877" - }, - { - "brief_title": "Extensive Peritoneal Lavage After Curative Gastrectomy for Gastric Cancer: A Randomised Controlled Trial", - "phase": "", - "drugs": "['Extensive Peritoneal Lavage']", - "drugs_list": [ - "Extensive Peritoneal Lavage" - ], - "diseases": "['Gastric Cancer']", - "diseases_list": [ - "Gastric Cancer" - ], - "enrollment": "600.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who have T3 (subserosal) or T4 (serosal) disease based on CT scan and intra-operative inspection with any N staging and M0 gastric cancer. \n\n Patients planned for open or laparoscopic gastrectomy. \n\n Patients undergoing gastrectomy with curative intent. \n\n Lower age limit of research subjects 21 years old and upper age limit of 80 years old. \n\n Ability to provide informed consent \n\n ", - "exclusion_criteria": ": \n\n Patients who undergo a palliative gastrectomy. \n\n Patients who undergo a gastrectomy as emergency. \n\n Vulnerable persons under age of 21. \n\n Patients receiving neoadjuvant therapy. \n\n Patients presented with life-threatening bleeding from tumour \n\n ASA score of 4 & 5 \n\n Patients with another primary cancer within last 5 years \n\n Patients with gross peritoneal and liver metastasis at surgery.", - "brief_summary": "This study is carried out to determine the merit and reliability of extensive intraoperative peritoneal lavage as a preventive strategy~Hypothesis: EPL significantly improve the overall survival of patients by reducing the risk of peritoneal recurrence", - "NCTID": "NCT02140034" - }, - { - "brief_title": "Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus in Principle (Hyperthermic Intraperitoneal Chemotherapy) HIPEC in Colorectal Patients", - "phase": "Phase 3", - "drugs": "['laparotomy plus HIPEC']", - "drugs_list": [ - "laparotomy plus HIPEC" - ], - "diseases": "['Colorectal Cancer With a Resected Minimal Synchronous PC', 'Ovarian Metastases', 'Tumour Rupture in the Abdominal Cavity']", - "diseases_list": [ - "Colorectal Cancer With a Resected Minimal Synchronous PC", - "Ovarian Metastases", - "Tumour Rupture in the Abdominal Cavity" - ], - "enrollment": "130.0", - "inclusion_criteria": "inclusion criteria: \n\n A) Patients presenting with the following history: \n\n Histologically-proven colorectal adenocarcinoma \n\n Presenting at the time of resection of the primary with one of the following 4 criteria (criteria indicating a high risk of developing PC) : \n\n Minimal PC, resected at the same time as the primary \n\n Ovarian metastases \n\n Rupture of the primary tumour inside the peritoneal cavity, \n\n Iatrogenic rupture of the primary tumour during surgery \n\n B) Who have received standard systemic adjuvant chemotherapy (6 months of systemic chemotherapy) : \n\n Chemotherapy with the Folfox 4 regimen (the current standard treatment ; it can be modified in the future in the two groups, if the standard is modified\u2026). \n\n Given on an intent-to-treat basis (it can be stopped prematurely for miscellaneous reasons\u2026); \n\n C) Patients who do not present any sign of tumour recurrence at the end of these 6 months of chemotherapy. \n\n D) Patients with the following general characteristics: \n\n Age between 18 and 70 years, \n\n Performance Status WHO < 2, life expectancy > 12 weeks, \n\n Haematological parameters : Polynuclear neutrophils \u00b3 1.5x109/L, platelets \u00b3 100x109/L, \n\n Liver function : Total Bilirubin \u00a3 1.5 x ULN, AST (SGOT) et ALT (SGPT) \u00a3 3 x ULN, alkaline phosphatases \u00a3 3 x ULN, \n\n Renal function : Plasma creatinine \u00a3 1,25 x ULN, \n\n Operable patients, \n\n Grade \u00a3 2 peripheral neuropathy (CTC AE v3.0 annex 7) \n\n Patients entitled to French National Health Insurance coverage. \n\n E)Patients will be informed and a signed consent form will be obtained before initiating any procedure specific to the trial. \n\n ", - "exclusion_criteria": ": \n\n Cancers of non colorectal origin, particularly, appendiceal cancers are excluded \n\n Patients presenting with a detectable recurrent tumour \n\n Grade \u2265 3 Peripheral neuropathy \n\n History of cancer (excepted cutaneous basocellullar cancer or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years \n\n Patients already included in another trial concerning first-line treatment 6) Pregnant women or likely to be pregnant \n\n 7) Persons under guardianship 8) Follow-up impossible for geographic, social or psychological reasons", - "brief_summary": "Multicentric randomised trial. Patients with a high risk of developing colorectal Peritoneal Carcinomatosis (PC) after resection of their primary will be informed, will sign the consent and will be pre-registered. All patients will receive the current standard adjuvant treatment : 6 months of systemic chemotherapy (currently the Folfox-4 regimen which could be modified if the standard is modified). Then a work-up is done to exclude recurrence. The likelihood of a recurrence is low but if this occurs, the patient will not be randomised and will be treated with the best known treatment. If the work-up is negative, patients will be randomised to surveillance alone (control group) or exploratory laparotomy + HIPEC (experimental group).", - "NCTID": "NCT01226394" - }, - { - "brief_title": "Ultra Structure Of Peritoneum At Electronic Microscopy In Control Subjects And Patients With Gastric Cancer", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Stomach Neoplasm']", - "diseases_list": [ - "Stomach Neoplasm" - ], - "enrollment": "18.0", - "inclusion_criteria": "inclusion criteria: \n\n patients with operable local gastric adenocarcinoma \n\n ", - "exclusion_criteria": ": \n\n previous abdominal surgery \n\n previous open or blunt abdominal trauma \n\n history of inflammatory bowel disease or Typhoid Fever, Gallstone disease, chemotherapy or radiotherapy, or any other abdominal condition that could alter peritoneal integrity. \n\n All other gastric malignancies such as lymphomas, GIST, carcinoids", - "brief_summary": "Peritoneal metastases appear in a great proportion of patients affected by gastric carcinoma. Involved mechanisms are poorly understood though experimentally it has been demonstrated that neoplastic cells exfoliated from primary tumor can only implant and proliferate in areas of damaged peritoneum. Objectives: to study ultra-structure of peritoneal surface by electronic microscopy in control subjects and in patients with early or locally advanced gastric cancer looking for spontaneous changes in peritoneal surface not related with surgical injury.", - "NCTID": "NCT00935779" - } - ], - "1": [ - { - "brief_title": "Studies of Disorders in Antibody Production and Related Primary Immunodeficiency States", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Hyper-IgM Syndrome', 'Ectodermal Dysplasia']", - "diseases_list": [ - "Hyper-IgM Syndrome", - "Ectodermal Dysplasia" - ], - "enrollment": "119.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients must have a known or suspected immune defect with hyper-IgM syndrome and/or disorders of immunoglobulin production. There will be no limit on age, sex, race, or disability. Normal volunteers must be healthy adults between the age of 18 and 70 years. All study participants enrolled on to this study must agree to allow PI to store research samples. Refusal to let PI store samples may lead to withdrawal fro this specific study. \n\n ", - "exclusion_criteria": ": \n\n The presence of an acquired abnormality, which leads to immune defects, such as HIV, chemotherapy, and malignancy are general ", - "brief_summary": "This study investigates gene abnormalities in Primary Immune Deficiency(PID) with a goal of improving the diagnosis and treatment of patients.~The specific disorders include:~X linked hyper IgM Syndrome which is caused by an abnormality in the CD40L gene.~NEMO associated immune deficiency which is caused by an abnormality in a gene called NEMO.~Common variable immunodeficiency (CVID) which has an unknown genetic basis.~Other disorders of immunoglobulin production.~This study will:~Better characterize the clinical features of CD40 L deficiency and NEMO associated immune deficiency and other related primary immune deficiency syndromes.~Determine the frequency of CD40 L and Nemo abnormalities.~Determine whether particular abnormalities in these genes are associated with more of less severe illness or with specific symptoms.~Explore the basic mechanism by which these altered genes cause immune dysfunction.~Identify other genes causing low immune globulin levels and related primary immune deficient states.", - "NCTID": "NCT00266513" - }, - { - "brief_title": "STA-5326 Meslylate to Treat Gut Inflammation Associated With Common Variable Immunodeficiency", - "phase": "Phase 1", - "drugs": "['STA-5326']", - "drugs_list": [ - "STA-5326" - ], - "diseases": "['Common Variable Immunodeficiency']", - "diseases_list": [ - "Common Variable Immunodeficiency" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n A subject is eligible for the study if all of the following criteria are met: \n\n Has given written informed consent prior to screening. \n\n Is male or female aged 18 through 75 years. \n\n Has CVID diagnosed definitively prior to screening (based on the IUIS criteria). \n\n Has a documented, unintended loss of greater than 5% of their body weight over the last year or requires nutritional supplements to maintain his/her body weight OR has chronic diarrhea defined as a complaint of liquid stools for at least 4 consecutive weeks (and an output of greater than 200 g stool/24hr on a diet of at least 1600 calories with 60 g fat.) \n\n If taking oral antibiotics chronically, must have used a stable dose of the antibiotic continuously for at least 2 weeks prior to start of screening period. \n\n Not taking any potential CYP3A4 inhibitors/inducers (e.g., macrolide antibiotics, HIV protease inhibitors, antifungals, grapefruit juice, St. John's Wort). \n\n ", - "exclusion_criteria": ": \n\n A subject is excluded from the study if any of the following criteria are met: \n\n General Criteria: \n\n Has any clinically significant disease (e.g., renal, hepatic, neurological, cardiovascular, pulmonary, endocrinologic, psychiatric, hematologic, urologic, or other acute or chronic illness) that in the opinion of the investigator would make the subject an unsuitable candidate for this trial. \n\n Is a woman who has a positive serum pregnancy test or who is breast-feeding. \n\n Is a woman of childbearing potential or a man who does not agree to use two forms of contraception during the course of the study and follow-up period. \n\n Has hypersensitivity to any of the components of STA 5326 mesylate drug product. \n\n Has any of the following clinical chemistry values: \n\n AST greater than 2.5 x upper limit of normal (ULN). \n\n ALT greater than 2.5 x ULN. \n\n Serum bilirubin greater than 1.5 x ULN. \n\n Serum creatinine greater than 1.5 x ULN. \n\n Alkaline phosphatase greater than 2.5 x ULN. \n\n Has a hemoglobin level less than 9 g/dL or hematocrit less than 30%. \n\n Has a Prothromin Time INR greater than 1.3 or a Partial Thromboplastin Time greater than 3 sec compared to control value. \n\n Has the following cell counts (cells/microliter): \n\n Platelet count less than 90,000 or greater than 800,000. \n\n White blood cell count less than 1,500. \n\n Neutrophil count less than 900. \n\n Has a current infection requiring intravenous antibiotics, a serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia). \n\n Has a history of cancer within the past 5 years, with the exception of excised basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ. \n\n Had a dependency for any illicit drug, chemical, or alcohol within the past 5 years. \n\n Has a history of active tuberculosis (or a CXR with findings suggestive of old TB infection including calcified nodular lesions, apical fibrosis, or pleural scarring), acute or chronic hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). \n\n Gastrointestinal Criteria: \n\n Has a stool sample positive for gastrointestinal infection during screening. \n\n Has a positive hydrogen breath test \n\n Prior Medication Criteria: \n\n Received parenteral corticosteroids within 1 month prior to receiving study drug. The use of short-term or single-dose corticosteroids as a pretreatment regimen for IVIG is acceptable. \n\n Received any investigational drug within 3 months prior to receiving study drug. \n\n Received cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 2 months prior to receiving study drug. \n\n Received any biological product (e.g., infliximab, adalimumab, natalizumab, etc.) within 3 months prior to receiving study drug. \n\n Ever received treatment with STA-5326 mesylate, anti-IL 12 antibodies, or other specific IL 12 inhibitors.", - "brief_summary": "This study will determine whether an experimental medicine, STA-5326 mesylate, is safe to use in patients with common variable immunodeficiency (CVID) who have inflammation of the gut. It will also determine if patients who take this drug show improvement in their symptoms, decrease in inflammatory chemicals in the gut, changes in their immune cells, and improvement in how their gut is functioning to absorb food.~Patients between 18 and 75 years of age with CVID and chronic diarrhea or involuntary weight loss of more than 5 percent of their past body weight over the past 12 months may be eligible for this study. Candidates are screened with a review of their medical records, a medical history and physical examination, blood, urine and stool tests, chest x-rays and skin test for exposure to tuberculosis, and a hydrogen breath test. For the latter, breath samples are collected before and every 20 minutes (for 2 hours) after the subject drinks a sugar solution. This test determines the digestive effects of bacteria in the upper intestine. Samples are collected by having the subject blow into a balloon.~Participants undergo the following tests and procedures:~Immune System and Gastrointestinal Evaluation~48-hour stool fat collection (measures the amount of undigested fat in the stool): Subjects keep a diary of what they eat for a 48-hour period. At the beginning of the 48 hours they take two dye capsules and then take another two capsules 48 hours later. They collect a stool sample when they pass the second set of capsules in their bowel movement. An additional 24-hour stool collection is tested for loss of protein in the stool.~D-xylose absorption test (measures the ability of the gut to absorb nutrients): Subjects drink a solution of d-xylose (a sugar substitute). Blood samples are collected before and 1 hour after drinking the solution.~Upper endoscopy: A thin flexible lighted tube is advanced through the mouth to evaluate the esophagus, stomach and beginning of the small intestine.~Lower endoscopy: A thin flexible lighted tube is advanced through the rectum to evaluate the colon.~Treatment Period (Study days 1 to 57)~Physical examination - study days 1, 8, 15, 29, 43 and 57~Blood samples to test the levels of STA-5326 in the blood. On study days 1 and 57, samples are collected before the medication dose and 1, 2, 4, 6 and 8 hours after the dose; on day 29, one sample is collected before the medication dose.~Blood samples for routine safety testing - study days 1, 8, 15, 29, 43 and 57~Medication history - study days 1, 8, 15, 29, 43 and 57~Interview about pain, discomfort, and well being - study days 1, 8, 15, 29, 43 and 57~Pregnancy test for women who can become pregnant - study days 15, 43, and 57~D-xylose absorption test - study days 29 and 57~Electrocardiogram - study days 29 and 57~Urine test - study days 29 and 57~Blood test for research on immune cells - study day 57~Repeat endoscopies and studies of gut function (24- and 48-hour stool collections)~Follow-up period (Day 85 and day 113)~-Physical examination, blood tests, medication history, questions about pain, discomfort and well being", - "NCTID": "NCT00263237" - }, - { - "brief_title": "Consequences of DNA Repair and Telomere Defects on the Function of the Immune System: Application to CVID and Immune Deficiencies With Dysmorphic Syndromes", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Immune Deficiency and Early BMF in Childhood']", - "diseases_list": [ - "Immune Deficiency and Early BMF in Childhood" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Immune Deficiency and early BMF in childhood \n\n Common Variable Immunodeficiency (CVID) \n\n Genetic patients \n\n ", - "exclusion_criteria": ": \n\n Refusal to consent.", - "brief_summary": "The molecular mechanisms participating in the various aspects of the DNA Damage Response (DDR) are absolutely essential to maintain the genome dynamics essential to all living organisms. The most commonly studied consequence of faulty DDR is genome instability participating in cancer onset. In the present proposal, we wish to explore another aspect of DDR, not relevant to cancer, which is its absolute requirement at several key steps of the development, maturation, and function of the immune system.~The most spectacular consequences of faulty DNA repair processes with respect to the immuno-hematopoietic tissue are the complete block of B and T lymphocytes maturation owing to defective DNA joining phase during V(D)J recombination resulting in patients with Severe Combined Immune Deficiency (SCID).~The objectives of this study are to increase our knowledge on the role of the various DNA repair processes in the development, the maintenance, and the function of the immune system and thus, to better understand why and how dysfunctions of these DNA repair processes result in human severe conditions such as CVID, LOCID or other manifestations of immune disorders such as autoimmunity.~The explorations of DNA repair mechanisms in the patients will allow us to establish the genetic diagnosis in some patients with until now undefined molecular diagnosis. This is of immediate importance for the patients and their families, as it not only contributes to a better understanding of the patients' condition, but also allows providing genetic counseling for the families.", - "NCTID": "NCT02556359" - }, - { - "brief_title": "T.E.A. Study Three Days Ertapenem Versus Three Days Ampicillin- Sulbactam", - "phase": "Phase 4", - "drugs": "['Ertapenem', 'Ampicillin-Sulbactam']", - "drugs_list": [ - "Ertapenem", - "Ampicillin-Sulbactam" - ], - "diseases": "['Intra-Abdominal Infection']", - "diseases_list": [ - "Intra-Abdominal Infection" - ], - "enrollment": "142.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult patients ( > 18 years) requiring surgical intervention within 24 hours of diagnosis, for localized IAI infections (i.e extending beyond the organ wall but confined near the hollow viscus, mild to moderate in severity): \n\n Acute appendicitis: Ruptured or perforated with abscess \n\n Acute diverticulitis with perforation and/or abscess \n\n Acute cholecystitis (including gangrenous) with either rupture or perforation \n\n Acute gastric and duodenal ( > 24 hours) perforation \n\n Traumatic (> 12 hours) perforation of the intestines \n\n Secondary peritonitis due to perforated viscus \n\n Intra-abdominal abscess (including of liver and spleen) \n\n ", - "exclusion_criteria": ": \n\n Traumatic bowel perforation requiring surgery within 12 hours \n\n Perforation of gastroduodenal ulcers requiring surgery within 24 hours \n\n other intra-abdominal processes in which the primary etiology was unlikely to be infectious. \n\n Patients lactating or pregnant \n\n Patients with a history of allergy, hypersensitivity, or any severe reaction to the study antibiotics \n\n Patients with rapidly progressive or terminal illness; \n\n Patients with a history or presence of severe hepatic or renal disease (e.g. creatinine clearance < 0.5 ml/min/1.73 m2); \n\n Patients with a concomitant infection that would interfere with evaluation of response to the study antibiotics.", - "brief_summary": "The aim of the study was to compare the activity (efficacy and safety) of Ertapenem administered according to a short treatment for three days versus a short treatment for three days with AS in patients with an community acquired IAI of mild to moderate severity.", - "NCTID": "NCT00630513" - }, - { - "brief_title": "Safety and Efficacy Study to Compare IV CXA 101/Tazobactam and Metronidazole With Meropenem in Complicated Intraabdominal Infections", - "phase": "Phase 2", - "drugs": "['CXA-101/ tazobactam and metronidazole', 'meropenem plus saline placebo']", - "drugs_list": [ - "CXA-101/ tazobactam and metronidazole", - "meropenem plus saline placebo" - ], - "diseases": "['Complicated Intra-abdominal Infection']", - "diseases_list": [ - "Complicated Intra-abdominal Infection" - ], - "enrollment": "122.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female, from 18 to 90 years of age, inclusive \n\n One of the following diagnoses (in which there is evidence of intraperitoneal infection) including:(a) Cholecystitis (including gangrenous cholecystitis) with rupture, perforation, or progression of the infection beyond the gallbladder wall;(b)Diverticular disease with perforation or abscess; (c) Appendiceal perforation or periappendiceal abscess; (d) Acute gastric or duodenal perforation, only if operated on >24 hours after perforation occurs; (e) Traumatic perforation of the intestine, only if operated on > 12 hours after perforation occurs; (f) Peritonitis due to perforated viscus, postoperative or spread from other focus of infection (but not spontaneous [primary] bacterial peritonitis or peritonitis associated with cirrhosis and chronic ascites).Subjects with inflammatory bowel disease or ischemic bowel disease are eligible provided there is bowel perforation; or (g) Intraabdominal abscess (including liver and spleen). \n\n Subject requires surgical intervention (e.g. laparotomy, laparoscopic surgery, or percutaneous draining of an abscess) within 24 hours of (before or after) the first dose of study drug \n\n If subject is to be enrolled preoperatively, the subject must have radiographic evidence of bowel perforation or intraabdominal abscess \n\n Subjects who failed prior antibacterial treatment for the current cIAI can be enrolled but must: (a) have a positive culture (from an intraabdominal site) and (b) require surgical intervention. Such subjects can be enrolled before the results of the culture are known; however, if the culture is negative, study drug administration must be discontinued. \n\n Willing and able to comply with all study procedures and restrictions \n\n Willing and able to provide written informed consent \n\n ", - "exclusion_criteria": ": \n\n Women who are pregnant, nursing, or - if of child bearing potential - not using a medically accepted, effective method of birth control (e.g. condom, oral contraceptive, indwelling intrauterine device, or sexual abstinence) \n\n Diagnosis of abdominal wall abscess; small bowel obstruction or ischemic bowel disease without perforation; traumatic bowel perforation with surgery within 12 hours; perforation of gastroduodenal ulcer with surgery within 24 hours (these are considered situations of peritoneal soiling before infection has become established); another intraabdominal process in which the primary etiology is not likely to be infectious. \n\n Simple cholecystitis, gangrenous cholecystitis without rupture, simple appendicitis, acute suppurative cholangitis, infected, necrotizing pancreatitis, or pancreatic abscess \n\n cIAI managed by staged abdominal repair (STAR), open abdomen technique or any situation where infection source control is not likely to be achieved \n\n Known prior to randomization to have an IAI or postoperative infection caused by pathogen(s) resistant to meropenem \n\n Considered unlikely to survive the 4- to 5-week study period \n\n Any rapidly-progressing disease or immediately life-threatening illness (including acute hepatic failure, respiratory failure and septic shock) \n\n The need for concomitant systemic antibacterial agents (other than vancomycin or linezolid) in addition to study drug(s) \n\n Moderate or severe impairment of renal function (estimated CrCl < 50 mL/min), or requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (< 20 mL/h urine output over 24 hours) \n\n The presence of hepatic disease defined as: (a) ALT or AST > 4 x ULN; (b)Total bilirubin >2 x ULN, unrelated to cholecystitis (c) Alkaline phosphatase >4 x ULN. Subjects with a value >4 x ULN and <5 x ULN are eligible if this value is historically stable. \n\n Subjects with acute hepatic failure or acute decompensation of chronic hepatic failure \n\n Hematocrit < 25% or hemoglobin < 8 gm/dL \n\n Neutropenia with absolute neutrophil count < 1000/mm3 \n\n Platelet count < 75,000 /mm3. Subjects with a platelet count as low as 50,000 /mm3 are permitted if the reduction is historically stable. \n\n Immunocompromising illness, including known human immunodeficiency virus (HIV) positivity or AIDS, organ (including bone marrow) transplant recipients, and hematological malignancy. Immunosuppressive therapy, including use of high-dose corticosteroid therapy (e.g. >40 mg prednisone or equivalent per day for greater than 2 weeks). \n\n History of hypersensitivity reactions to cephalosporins, carbapenems, penicillins, \u00df-lactamase inhibitors, metronidazole, or nitroimidazole derivatives. Subjects with a history of mild skin rash, not documented to be caused by previous \u00df-lactam use, may be enrolled. \n\n Any condition or circumstance that, in the opinion of the Investigator, would compromise the safety of the subject or the quality of study data \n\n Clinically significant abnormality in baseline electrocardiogram (ECG) \n\n Participation in any investigational drug or device study within 30 days prior to study entry \n\n Use of systemic antibiotic therapy for IAI for 24 or more hours in the 48-hour period prior to the first dose of study drug, unless there is a documented treatment failure with such therapy \n\n More than one dose of an active non-study antibacterial regimen was given postoperatively. For subjects enrolled preoperatively, no postoperative non-study antibacterial therapy is allowed \n\n who previously participated in a study with CXA-101 \n\n Subjects who previously received imipenem, meropenem, doripenem or cefepime for the current intraabdominal infection \n\n Subjects who have received disulfiram in the past 14 days or who are currently receiving probenecid.", - "brief_summary": "A Phase 2, multicenter, prospective, randomized, double-blind study of CXA-101/ tazobactam (1000/500 mg q8h) and metronidazole (500 mg q8h) IV infusion vs. meropenem IV infusion (1000 mg q8h) and a matching saline placebo (q8h) in the treatment of cIAI in adult subjects. Dose adjustments for subjects with mild renal impairment are not necessary and subjects with more severe degrees of renal failure are excluded.", - "NCTID": "NCT01147640" - }, - { - "brief_title": "Plasma and Abscess Fluid Pharmacokinetics of Cefpirome and Moxifloxacin After Single and Multiple Dose Administration", - "phase": "Phase 4", - "drugs": "['cefpirome and moxifloxacin administration']", - "drugs_list": [ - "cefpirome and moxifloxacin administration" - ], - "diseases": "['Abscess', 'Cysts']", - "diseases_list": [ - "Abscess", - "Cysts" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Female or male, aged between 18 and 90 years. \n\n Written informed consent. \n\n Abscess formation or abdominal cyst scheduled to drainage. \n\n Plasma creatinine <1.5 mg/dL \n\n ", - "exclusion_criteria": ": \n\n Pregnancy or lactation. \n\n Hemodialysis or hemofiltration \n\n Allergy or hypersensitivity against study drugs \n\n Massive edemata or hypernatremia \n\n Reduced liver function (Child-Pugh A, B, C) \n\n Relevant prolongation of QT-interval \n\n CNS-diseases which predispose for cramps", - "brief_summary": "Penetration of cefpirome and moxifloaxacin into abscess fluid of humans will be tested. Patients with an abscess scheduled for drainage will receive study drugs (single or multiple dose), pus samples and plasma samples will be collected and analyzed by High pressure liquid chromatography (HPLC). Pharmacokinetics of the study drugs in pus and plasma will be determined using a pharmacokinetic model.", - "NCTID": "NCT00280514" - }, - { - "brief_title": "Prevalence of Colon Cancer in Pyogenic Liver Abscess", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cryptogenic Pyogenic Liver Abscess']", - "diseases_list": [ - "Cryptogenic Pyogenic Liver Abscess" - ], - "enrollment": "62.0", - "inclusion_criteria": "inclusion criteria: \n\n Pyogenic liver abscess radiologically and bacteriologically diagnosed \n\n ", - "exclusion_criteria": ": \n\n Amebic liver abscess \n\n Other causes of pyogenic liver abscess such as cholangitis, liver cancer, complication of transarterial chemoembolization or radiofrequency ablation to hepatocellular carcinoma \n\n Refusal to colonoscopic examination \n\n Inadequate general patient status to perform the colonoscopic examination \n\n Patient who has had the screening colonoscopic examination within 1 year and showed normal finding or had 1 or 2 colon polyp in adequate exam", - "brief_summary": "Although a proportion of pyogenic liver abscess may originated from colonic mucosal lesions, the prevalence of colonic neoplasm in the patients with pyogenic liver abscess are still not evaluated yet. Thus, our group will find the prevalence of colonic neoplasm in the group of cryptogenic pyogenic liver abscess by colonoscopic examination.", - "NCTID": "NCT02032914" - }, - { - "brief_title": "Cell Infusion Intraportal Autologous Bone Marrow Mononuclear as Enhancer of Liver Regeneration", - "phase": "Phase 2", - "drugs": "['Cell infusion intraportal mononuclear bone marrow autologous and portal embolization of the affected segments.']", - "drugs_list": [ - "Cell infusion intraportal mononuclear bone marrow autologous and portal embolization of the affected segments." - ], - "diseases": "['Liver Transplant Rejection']", - "diseases_list": [ - "Liver Transplant Rejection" - ], - "enrollment": "13.0", - "inclusion_criteria": "inclusion criteria: \n\n - Patients of both sexes aged \u2265 18 years. \n\n - Standard analytical parameters, defined by: \n\n Leukocytes \u2265 3000 \n\n Neutrophils \u2265 1500 \n\n Platelets \u2265 100,000 \n\n Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) \u2264 1.5 standard range institution \n\n creatinine \u2264 1.5 mg / dl \n\n - Patients with liver space occupying lesion (LOE) that require extended hepatic resection. \n\n Patient selection should be cautious, covering basically 5 types of liver damage which must be submitted prior to liver volumetry: \n\n Metastatic Disease subsidiary right hepatectomy extended to segment IV \n\n Metastatic Disease subsidiary right hepatectomy with suspected diseased liver (neoadjuvant chemotherapy) (in cases of doubt may be used liver function test indocyanine green) \n\n Bilobar liver metastases with multiple nodules in the right lobe and more than 3 nodules greater than 30 mm in the left hepatic lobe (LHI) will perform lumpectomies the LHI + right portal branch ligation (or postoperative percutaneous embolization) in order to make right hepatectomy 4-6 weeks (two stage surgery) \n\n Subsidiary Hepatocarcinoma extended right hepatectomy \n\n Liver Injury benign / malignant (Hemangiomas, hydatid cysts or liver tumors / primary bile hepatoblastoma), which by extension threatens the viability of the remaining liver tissue. \n\n 4 - Patients give their written informed consent for participation in the study and provide sufficient guarantees adherence to protocol according to the opinion of the investigator in charge of the patient care. \n\n ", - "exclusion_criteria": ": \n\n Different tumor records current disease or any disease hematologic. \n\n Patients with uncontrolled hypertension. \n\n Severe heart failure (NYHA IV). \n\n Patients with malignant ventricular arrhythmias or unstable angina. \n\n Diagnosis of deep vein thrombosis in the previous 3 months. \n\n Adjunctive therapy including hyperbaric oxygen, vasoactive substances, agents or angiogenesis inhibitors against Cox-II. \n\n BMI> 40 kg/m2. \n\n Patients with alcoholic with active alcoholism. \n\n Proliferative retinopathy. \n\n Concomitant disease that reduces life expectancy to less than a year. \n\n Difficulty in monitoring. \n\n Heart failure or ejection fraction (EF) <30%. \n\n Stroke or myocardial infarction within the last 3 months. \n\n Pregnant women or women of childbearing age who do not have adequate contraception.", - "brief_summary": "This is a randomized controlled trial in which the safety and feasibility of cell therapy medicinal product shall be measured by comparing the variables of the response after treatment compared to baseline prior to implementation. Secondarily the results obtained are compared with each of the study groups.~Patients will receive concomitant basic pharmacological treatment for maintaining liver function.~All patients will be equally medically treated. The hypothetic test is to propose mononuclear cells from the bone marrow infused in the territory hepatic portal remaining segments (II and III) to be performed while contralateral portal embolization provides progenitor cells hepatic regenerative capacity that would shorten the time of liver regeneration and increase residual volume, facilitating the realization of an extended hepatectomy with greater assurance of maintaining proper residual function and adequate surgical margins.", - "NCTID": "NCT01745731" - }, - { - "brief_title": "Natural History of Noncirrhotic Portal Hypertension", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cystic Fibrosis', 'Immunologic Deficiency Syndrome', 'Turner Syndrome', 'Congenital Hepatic Fibrosis', 'Idiopathic Non-Cirrhotic Portal Hypertension']", - "diseases_list": [ - "Cystic Fibrosis", - "Immunologic Deficiency Syndrome", - "Turner Syndrome", - "Congenital Hepatic Fibrosis", - "Idiopathic Non-Cirrhotic Portal Hypertension" - ], - "enrollment": "400.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 12 years or above, male or female \n\n Known diagnosis of NCPH, or to be at the risk for NCPH by virtue of underlying disease processes such as but not limited to; CGD, SCD, Mastocytosis, CVID, CF, and CHF. \n\n ", - "exclusion_criteria": ": \n\n Evidence of other forms of liver disease that typically result in cirrhosis. \n\n Evidence of active chronic Hepatitis B infection as defined by the presence of hepatitis B surface antigen (HBsAg) in serum and elevated HBV DNA (>10,000 IU/mL). \n\n Hepatitis C as defined by the presence of hepatitis C RNA in serum. \n\n Primary sclerosing cholangitis as defined by liver histology. \n\n Primary biliary cirrhosis as defined by cholestasis, +/- antimitochondrial antibody positivity and liver histology. \n\n Wilson s disease as defined by ceruloplasmin below the limits of normal and liver histology and urinary copper consistent with Wilson disease. \n\n Autoimmune hepatitis as defined by antinuclear antibody (ANA) of 3 EU or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy for autoimmune hepatitis. \n\n Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy or homozygosity for C282Y. Patients with iron saturation indices of >45% and serum ferritin levels of >300 ng/ml for men and >250 ng/ml for women will undergo genetic testing for hemochromatosis. \n\n Bile duct obstruction as suggested by imaging studies done within the previous six months. \n\n The presence of cirrhosis as demonstrated by liver biopsy. \n\n Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year (assessed during patient interviews by patient self-report). \n\n Evidence of hepatocellular carcinoma; either alpha-fetoprotein (AFP) levels greater than 50 ng/ml (normal <6.6ng/ml) and/or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer. \n\n Evidence of Cholangiocarcinoma as suggested by liver histology. \n\n Any other severe condition, which in the opinion of the investigators would impede the patient s participation or compliance in the study. \n\n Inability to comply or give written informed consent.", - "brief_summary": "Background:~- Noncirrhotic Portal Hypertension (NCPH) is caused by liver diseases that increase pressure in the blood vessels of the liver. It seems to start slowly and not have many warning signs. Many people may not even know that they have a liver disease. There are no specific treatments for NCPH.~Objectives:~- To learn more about how NCPH develops over time.~Eligibility:~- People age 12 and older who have NCPH or are at risk for getting it. In the past year, they cannot have had other types of liver disease that typically result in cirrhosis, liver cancer, or active substance abuse.~Design:~Participants will have 2 screening visits.~Visit 1: to see if they have or may develop NCPH.~Medical history~Physical exam~Urine and stool studies~Abdominal ultrasound~Fibroscan. Sound waves measure liver stiffness.~- Visit 2:~Blood tests~Abdominal MRI~Echocardiogram~Questionnaire~Liver blood vessel pressure (hepatic venous portal gradient (HVPG)) measurement. This is done with a small tube inserted in a neck vein.~They may have a liver biopsy.~All participants will visit the clinic every 6 months for a history, physical exam, and blood tests. They will also repeat some of the screening tests yearly.~Participants with NCPH will also have:~Upper endoscopy test. A tube inserted in the mouth goes through the esophagus and stomach.~At least every 2 years: Esophagogastroduodenoscopy.~At least every 4 years: testing including HVPG measurements and liver biopsy.~Participants without NCPH will also have:~Liver biopsy and HVPG measurements to see if they have NCPH.~Every 2 years: abdominal MRI and stool studies.~The study will last indefinitely.", - "NCTID": "NCT02417740" - }, - { - "brief_title": "Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel in Cirrhotic Patients a Prospective Randomized Study", - "phase": "", - "drugs": "['LC was done using traditional method', 'LC was done using harmonic ACE']", - "drugs_list": [ - "LC was done using traditional method", - "LC was done using harmonic ACE" - ], - "diseases": "['Gall Bladder Stone in Cirrhotics']", - "diseases_list": [ - "Gall Bladder Stone in Cirrhotics" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n patients with liver cirrhosis with symptomatic gall bladder stone \n\n ", - "exclusion_criteria": ": \n\n patients above 80 years old, \n\n patients with history of upper laparotomy, \n\n patients with common bile duct stones \n\n and pregnant females.", - "brief_summary": "This study included group (A) (60 patients with liver cirrhosis and complaining of gall stone) in whom LC was done using traditional method (TM) by clipping both cystic duct and artery and dissection of gall bladder from liver bed by diathermy, and group (B) (60 patients with liver cirrhosis and complaining of gall stone) LC was done using harmonic scalpel (HS) closure and division of both cystic duct, artery and dissection of gall bladder from liver bed by harmonic scalpel. The Intraoperative and postoperative parameters were collected included duration of operation, postoperative pain, and complications.", - "NCTID": "NCT01009450" - } - ], - "2": [ - { - "brief_title": "Molecular and Clinical Studies of Primary Immunodeficiency Diseases", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Wiskott- Aldrich Syndrome', 'ADA Deficient SCID']", - "diseases_list": [ - "Wiskott- Aldrich Syndrome", - "ADA Deficient SCID" - ], - "enrollment": "266.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with a clinical history or signs and symptoms suggestive of a primary immune deficiency syndrome and their family members are eligible for inclusion in this study and they may be referred by their physician or self-referred. If possible, a local physician/clinical immunologist will be identified for self-referred patients to serve as primary reference. If screening of the patients, either by phone interview or review of their medical records indicates that the patient may have a primary immunodeficiency syndrome and is HIV-negative, the patient will be invited to come to the NIH and sign an informed consent. If family history is positive for immunodeficiency, the patients or family members may be asked to invite other relatives to contact the PI to participate in the study. \n\n Patients who were enrolled under such inclusion criteria may continue to be seen under the protocol under the medical advisory supervision of Dr. Harry Malech. New enrollments will be limited to children with established and verified diagnosis of ADA-SCID cared for by our collaborators at UCLA and from whom we will only \n\n receive blood samples. \n\n ", - "exclusion_criteria": ": \n\n Inability of the subject or the subject s parent/guardian to provide informed consent. \n\n Patients infected with the Human Immunodeficiency Virus before enrollment.", - "brief_summary": "This study will try to identify mutations in the genes responsible for primary immunodeficiency disorders (inherited diseases of the immune system) and evaluate the course of these diseases in patients over time to learn more about the medical problems they cause. The immune system is composed of various cells (e.g., T and B cells and phagocytes) and other substances (complement system) that protect the body from infections and cancer. Abnormalities in the gene(s) responsible for the function of these components can lead to serious infections and other immune problems.~Patients with Wiskott-Aldrich syndrome, adenosine deaminase (ADA) deficiency. Participants will undergo a medical and family history, physical examination, and additional procedures and tests that may include the following:~Blood tests for: routine laboratory studies (i.e. cell counts, enzyme levels, electrolytes, etc.); HIV testing; immune response to various substances; genetic testing; and establishment of cell lines to maintain a supply of cells for continued study~Urine and saliva tests for biochemical studies~Skin tests to assess response to antigens such as the viruses and bacteria responsible for tetanus, candida, tuberculosis, diphtheria, chicken pox, and other diseases.~Skin and lymph node biopsies for tissue and DNA studies~Chest X-ray, CT scans, or both to look for cancer or various infections.~Pulmonary function test to assess lung capacity and a breath test to test for H. pylori infection.~Dental, skin and eye examinations.~Treatment with intravenous immunoglobulins or antibodies to prevent infections.~Apheresis for collecting white blood cells to study cell function. In this procedure, whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The white cells are then removed, and the red cells, platelets and plasma are returned to the body, either through the same needle or through a second needle placed in the other arm.~Bone marrow sampling to study the disease. A small amount of marrow from the hipbone is drawn (aspirated) through a needle. The procedure can be done under local anesthesia or light sedation.~Placental and umbilical cord blood studies, if cord blood is available, to study stem cells (cells that form blood cells).~Information gained from this study may provide a better understanding of primary immunodeficiencies, leading to better diagnosis and treatment. In addition, study participants may receive medical and genetic counseling and may be found eligible for other NIH studies on these diseases.", - "NCTID": "NCT00006319" - }, - { - "brief_title": "Use of Hypertonic Saline After Damage Control Laparotomy to Improve Early Primary Fascial Closure", - "phase": "", - "drugs": "['Primary Fascial Closure', 'wound vac dressing application']", - "drugs_list": [ - "Primary Fascial Closure", - "wound vac dressing application" - ], - "diseases": "['Open Abdomen After Damage Control Laparotomy']", - "diseases_list": [ - "Open Abdomen After Damage Control Laparotomy" - ], - "enrollment": "312.0", - "inclusion_criteria": "inclusion criteria: \n\n All admissions of trauma patients who sustain trauma necessitating damage control laparotomy. \n\n Male and female patients 18 years or older. \n\n ", - "exclusion_criteria": ": \n\n Children (<18 years old), prisoners, or pregnant patients. \n\n Patients who have more than 1/3 loss of abdominal wall due to trauma. \n\n Patients with baseline serum sodium of <120 mEq/L or >155 mEq/L.", - "brief_summary": "Damage control laparotomy (DCL) has proven to be a successful means to improve survival in severely injured patients.1-5 However, the consequences of not being able to close the fascia after the initial operation due to significant resuscitation leading to bowel and retroperitoneal edema, abdominal compartment syndrome, and continued acidosis, coagulopathy and hypethermia6-7 has led to a new challenge. Delays in primary fascial closure (PFC) contributes to increased fluid losses and nutritional demands,8-9 abdominal wall hernias, enterocutaneous fistula, and intra-abdominal infections.10-13 Hypertonic saline (HTS) use after DCL has been suggested to reduce bowel edema and resuscitation volumes, thus allowing for a quicker time to closure.14 Investigators will randomize patients to receiving HTS or standard crystalloid solutions after DCL and compare the time to PFC, rate of successful closure, and rate of complications associated with an open abdomen. The current failure rate of PFC after DCL is approximately 25%. Investigators believe they can improve PFC rates using hypertonic saline.", - "NCTID": "NCT02297659" - } - ] - }, - { - "patient_id": "sigir-201418", - "patient": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", - "0": [ - { - "brief_title": "Algorithm for Oliguria in Septic Shock", - "phase": "", - "drugs": "['Ultrasound']", - "drugs_list": [ - "Ultrasound" - ], - "diseases": "['Acute Kidney Injury']", - "diseases_list": [ - "Acute Kidney Injury" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Critically ill, adult patients AND with acute oliguric renal failure AND within 6 hours of presentation \n\n ", - "exclusion_criteria": ": \n\n i. Patients with pre-existing chronic renal failure ii. Patients on renal replacement therapy/ Dialysis iii. Patients with poor sonographic windows", - "brief_summary": "Acute Kidney Injury (AKI) develops in 88% to 30% of critically ill patients admitted to an intensive care unit and is a strong predictor of mortality.Therefore any management strategy that prevents progression of renal risk to injury or failure has the potential to improve outcomes in these patients.Conventional management of acute oliguria in shock has been to blindly 'push' fluids to improve renal perfusion or to give loop diuretics once fluid loading has been considered as accomplished. However both volume overload and 'blind' attempts at fluid removal can worsen renal injury and have been associated with higher mortality by venous overcongestion and inappropriate hypovolemia. It seems reasonable to assume that a bedside test to visualize volume status and renal perfusion may assist in improving outcomes in this cohort.The investigators developed a goal-directed ultrasonographic protocol to provide immediate hemodynamic information in acutely oliguric patients with shock as well as a management algorithm for guiding therapy. The investigators incorporated IVC diameter measurement, respiratory variation and response to a passive leg raise to assess whether further fluid boluses were required and a measurement of renal perfusion to determine whether diuretics or renal replacement therapy were indicated. The investigators aim to measure the effects of this management protocol on the rates of AKI in the study participants as compared to prior to the implementation of the protocol.The study design is a prospective, observational. Since this is a proof of concept study, the projected sample size is 40 patients. An interim analysis will be carried out after 20 patients are enrolled and a further 20 will be enrolled as necessary", - "NCTID": "NCT02338895" - }, - { - "brief_title": "Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Acute Kidney Injury']", - "diseases_list": [ - "Acute Kidney Injury" - ], - "enrollment": "2186.0", - "inclusion_criteria": "inclusion criteria: \n\n All infants born or admitted to a level 2 or 3 NICU will be screened. \n\n Infants who received intravenous fluids for > 48 hours will be eligible. \n\n ", - "exclusion_criteria": ": \n\n Infants admitted to the NICU at 2 weeks of age or older \n\n Infants who undergo cardiovascular surgery repair of a congenital heart lesion within 1 week of life \n\n Infants diagnosed with a lethal anomaly upon admission \n\n Infants who die within 48 hours after birth", - "brief_summary": "Introduction:~Based on single-center data, approximately 1 of every 3 newborns admitted to tertiary level neonatal intensive care units (NICU) develops acute kidney injury (AKI), and those with AKI have significantly worse outcomes. To stimulate discussion among researchers, the NIH NIDDK sponsored a workshop on neonatal AKI in April 2013. At that workshop, the group recognized the need to improve collaborations between neonatologists and nephrologists within and across centers. The investigators have created a multi-institutional, multi-disciplinary group, Neonatal Kidney Collaborative (NKC), in order to address the following critical needs identified at the workshop: AWAKEN is the inaugural study of this new collaboration.~Development of a standardized evidence-based definition of neonatal AKI~Evaluation of risk factors that predispose neonatal to AKI~Investigation into how fluid provision/ balance impacts biochemical and clinical outcomes", - "NCTID": "NCT02443389" - }, - { - "brief_title": "Pharmacology of Aminophylline for Acute Kidney Injury in Neonates", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Acute Kidney Injury']", - "diseases_list": [ - "Acute Kidney Injury" - ], - "enrollment": "9.0", - "inclusion_criteria": "inclusion criteria: \n\n Neonate < 3 months post natal age \n\n Diagnosed with acute kidney injury (AKI) \n\n Receiving aminophylline for AKI treatment as per local standard of care. \n\n ", - "exclusion_criteria": ": \n\n Presence of anatomical renal anomaly based on postnatal evaluation of the patient (hydronephrosis, multicystic kidney, renal agenesis, renal dysplasia, polycystic kidney, or obstructive uropathy) \n\n Patient on renal replacement therapy \n\n Major genetic abnormalities (trisomy 13, 18 or 21).", - "brief_summary": "Acute kidney injury (AKI) in critically ill neonates is common and associated with significant morbidity and mortality. No targeted therapeutic treatment strategies have been established for AKI in neonates. Within a clinical pharmacokinetic and pharmacodynamic conceptual framework, this project will examine the medication aminophylline as a potential treatment approach for AKI.", - "NCTID": "NCT02276170" - }, - { - "brief_title": "Incidence and Spectrum of Acute Kidney Injury in Cirrhotics and Assessment of New Biomarkers as Early Predictors of Acute Kidney Injury", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Acute Kidney Injury']", - "diseases_list": [ - "Acute Kidney Injury" - ], - "enrollment": "450.0", - "inclusion_criteria": "inclusion criteria: \n\n - Group A: 500 patients of cirrhosis with normal baseline renal function will be enrolled Group B : 200 patients who present with AKI (Acute Kidney Injury) will be enrolled \n\n ", - "exclusion_criteria": ": \n\n Age < 18 or > 70 years \n\n Preexisting Chronic Renal Disease \n\n Patients with obstructive uropathy. \n\n Cirrhosis with HCC (HepatoCellular Carcinoma). \n\n Advanced cardiopulmonary disease \n\n Pregnancy \n\n Patients with extrahepatic malignancy", - "brief_summary": "500 patients with normal renal function will be prospectively studied and incidence, spectrum and natural history of AKI (Acute Kidney Injury) will be observed in them and in 200 patients with abnormal renal function fulfilling AKI (Acute Kidney Injury) criteria will be prospectively studied for 1 year. Also biomarkers will be studied and validated as early predictors of AKI (Acute Kidney Injury).", - "NCTID": "NCT02016053" - }, - { - "brief_title": "Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery", - "phase": "Phase 2", - "drugs": "['Sodium Bicarbonate', 'Sodium Chloride']", - "drugs_list": [ - "Sodium Bicarbonate", - "Sodium Chloride" - ], - "diseases": "['Acute Kidney Injury', 'Congenital Heart Disease']", - "diseases_list": [ - "Acute Kidney Injury", - "Congenital Heart Disease" - ], - "enrollment": "51.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects age \u226418 years \n\n Subjects scheduled for cardiac surgery with cardiopulmonary bypass \n\n ", - "exclusion_criteria": ": \n\n Subjects with abnormal creatinine clearance (<90 ml/min/1.7m2) as measured by the Schwartz formula \n\n Subjects with known cystic kidney disease or posterior ureteral valves (subjects with solitary kidney, single multicystic/dysplastic kidney, hydronephrosis will not be excluded if renal function is preserved) \n\n Subjects with known metabolic disorder \n\n Premature infants born <30 weeks gestation and <30 days old due to risk of intraventricular hemorrhage \n\n Subjects in severe cardiogenic shock post-operative requiring extra-corporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD) will be withdrawn from the study.", - "brief_summary": "The proposed study will investigate the effect of sodium bicarbonate on the prevention of acute kidney injury in children undergoing cardiac surgery with cardio-pulmonary bypass. The investigators hypothesize that the occurrence of acute kidney injury will be less in children treated with sodium bicarbonate in the perioperative period when compared to placebo. The specific aims of this proposal are as follows:~1. To institute a prospective, randomized, double-blinded, placebo-controlled trial in pediatric subjects undergoing cardiac surgery to determine the efficacy of sodium bicarbonate on prevention of acute kidney injury as measured by pRIFLE criteria. 2. To examine whether treatment with sodium bicarbonate modifies the duration of acute kidney injury, fluid balance, hospital length of stay, need for dialysis, and progression to kidney failure. 3. To determine the relevance of NGAL as a biomarker to predict development of acute kidney injury.", - "NCTID": "NCT02046135" - }, - { - "brief_title": "Renal Insufficiency Following Contrast Media Administration Trial III", - "phase": "", - "drugs": "['RenalGuard system\u2122\u00ae (PLC Medical Systems, Inc. Franklin, MA, USA)']", - "drugs_list": [ - "RenalGuard system\u2122\u00ae (PLC Medical Systems", - "Inc. Franklin", - "MA", - "USA)" - ], - "diseases": "['Contrast Nephropathy']", - "diseases_list": [ - "Contrast Nephropathy" - ], - "enrollment": "700.0", - "inclusion_criteria": "inclusion criteria: \n\n All consecutive patients with chronic kidney disease (CKD) scheduled for coronary and/or peripheral angiography and/or angioplasty with an eGFR <45 ml/min/1.73 m2 and/or \n\n At high risk for CI-AKI according to Mehran's score \u226511 and/or Gurm's score >7 \n\n ", - "exclusion_criteria": ": \n\n Age <18 years \n\n Women who are pregnant \n\n Acute pulmonary edema \n\n Acute myocardial infarction \n\n Recent contrast media exposure \n\n End-stage CKD on chronic dialysis \n\n Multiple myeloma \n\n Current enrolment in any other study when enrolment in the REMEDIAL III would involve deviation from either protocol \n\n Cardiogenic shock \n\n Administration of theophilline, dopamine, mannitol and fenoldopam", - "brief_summary": "The urine flow rate (UFR)-guided and the left-ventricular end-diastolic pressure (LVEDP)-guided hydration regimens have been proposed to prevent contrast-induced acute kidney injury (CI-AKI). The REnal Insufficiency Following Contrast MEDIA Administration TriaL III (REMEDIAL III) trial is a randomized, multicenter, investigator-sponsored trial aiming to compare these 2 hydration strategies in high risk patients.~Patients with estimated glomerular filtration rate <45 ml/min/1.73 m2 and/or a high risk for CI-AKI (as defined according to both Mehran's score \u226511 and/or Gurm's score >7) will be enrolled. Patients will be divided in high (>12 mm Hg) and normal LVEDP, non-invasively estimated by transmitral flow velocity to annular velocity ratio (E/E' index). Patients in each group will be randomly assigned to 1) LVEDP-guided hydration with normal saline (LVEDP-guided group). The fluid infusion rate will be adjusted according to the LVEDP as follows: 5 mL/kg/hr for LVEDP <12 mmHg; 3 mL/kg/hr for 13-18 mmHg; and 1.5 mL/kg/hr for >18 mmHg. 2) UFR-rate guided hydration (RenalGuard group). In this group, hydration with normal saline plus low-dose of furosemide is controlled by the RenalGuard system, in order to reach and maintain a high (>300 mL/h) UFR. In all cases iobitridol (an low-osmolar, non ionic contrast agent) will be administered. The primary endpoint is the composite of CI-AKI (i.e., serum creatinine increase \u2265 25% and \u2265 0.5 mg/dl from the baseline value at 48 hours after contrast media exposure) and/or acute pulmonary edema.", - "NCTID": "NCT02489669" - }, - { - "brief_title": "Evaluation of Renal Blood Flow Using Contrast Enhanced Ultrasound for Differential Diagnosis of Acute Kidney Injury in Cirrhotic Patients: A Pilot Study", - "phase": "", - "drugs": "['Definity ultrasound contrast agent']", - "drugs_list": [ - "Definity ultrasound contrast agent" - ], - "diseases": "['Liver Cirrhosis and Acute Kidney Injury']", - "diseases_list": [ - "Liver Cirrhosis and Acute Kidney Injury" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n Age >18 years \n\n Cirrhosis of liver \n\n Hospitalization at University of Virginia Medical Center \n\n Diagnosis of acute kidney injury based on AKIN criteria \n\n ", - "exclusion_criteria": ": \n\n Known history of a right to left intracardiac shunt \n\n Known history of pulmonary hypertension, including portopulmonary hypertension \n\n Pregnancy or lactation \n\n History of allergies to Definity\u00ae \n\n History of Liver or Kidney Transplant \n\n Patient on hemodialysis", - "brief_summary": "Hepatorenal syndrome (HRS) is a common cause of acute kidney injury (AKI) in cirrhotic patients and has a one month survival rate of 50% and a 3 month survival rate of 20%. The leading theory behind HRS is selective vasoconstriction of renal vasculature in the setting of decreased systemic vascular resistance. Patients with liver cirrhosis suffer from a large degree of third spacing in the form of peripheral edema and ascites. In addition treatment with multiple drugs, including diuretics puts these patients at higher risks of prerenal AKI and ischemic acute tubular necrosis (ATN). AKI occurring due to HRS, prerenal AKI and ischemic or nephrotoxic ATN have different pathophysiologic mechanisms and are treated differently with significantly different outcomes. While renal perfusion is expected to be reduced in HRS and prerenal AKI, it is normal or increased in ATN. Prerenal AKI has the most favorable prognosis among these pathologies and treatment simply consists of volume expansion with blood, albumin, crystalloids or colloids. In clinical practice vasoactive agents such as midodrine and octreotide are used to increase the tone of splanchnic vessels and to improve renal perfusion. These interventions would not affect renal function in cases with ATN. Unfortunately, the diagnostic criteria proposed by the International Club for Ascites (ICA) for HRS are not specific and do not always exclude patients with other forms of acute kidney injury. Therefore, availability of a simple diagnostic tool for measurement of renal blood flow (RBF) at the bedside would be of great value in management of cases with cirrhosis of the liver presenting with acute reduction in kidney function. However, currently, there are no practical and simple tools available for this purpose.~Contrast enhanced ultrasonography (CEU) involves the intravenous injection of gas-filled microbubbles to enhance the ultrasound image of the organs and mainly to assess tissue vascularity and blood flow. We and others have used CEU to assess changes in RBF in response to physiologic stimuli and therapeutic interventions. Here we propose a prospective, pilot diagnostic study to validate the use of CEU, in assessing RBF in cirrhotic patients with AKI, and to assess the utility of CEU to differentiate between causes of AKI in cirrhotic patients.~Our hypothesis is that CEU will show arteriolar vasoconstriction and decreased blood flow in the renal cortex in patients with HRS which would not change in response to volume expansion. On the contrary, patients with prerenal AKI will have reduced RBF which will increase after volume expansion. Finally, those with ATN will not have a reduced RBF at baseline.~We plan to enroll 25 patients with liver cirrhosis and acute kidney injury who are admitted to the University of Virginia hospital into the study.~CEU will be performed on all subjects to measure baseline RBF. CEU will be repeated in all subjects within 24 hours after volume expansion with at least 1gm/kg of albumin (up to 100 gm/day) to assess a potential change. Hourly urine output and serum creatinine will be monitored for potential renal response to the volume expansion as part of clinical care. For the subgroup of subjects who receive treatment with combination therapy with albumin, midodrine, and octreotide (AMO) RBF assessment with CEU will be repeated after at least 48 hours of receiving this combination. Renal response will be assessed by monitoring urine output and serum creatinine monitored as part of clinical care. All subjects will have measurements of fractional excretion of sodium (FENa) and urea (FEUrea) and urine microscopy as a part of their routine clinical care (work up of AKI). The results of these tests and the response to volume expansion will be used to categorize subjects into three categories of AKI (HRS, prerenal AKI, ATN). Correlations between RBF and its changes between different therapeutic interventions and renal diagnosis will be tested in this study.", - "NCTID": "NCT02147470" - }, - { - "brief_title": "Spironolactone Administration to Prevent Ischemic Kidney Injury in Critically Ill Cancer Patients", - "phase": "Phase 2; Phase 3", - "drugs": "['Spironolactone', 'Placebo']", - "drugs_list": [ - "Spironolactone", - "Placebo" - ], - "diseases": "['Critically Ill', 'Cancer']", - "diseases_list": [ - "Critically Ill", - "Cancer" - ], - "enrollment": "24.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients admitted to the ICU in the immediate postoperative period (first 24 hours) of major surgery, defined as involving general anesthesia, ventilation, opening of large cavities (cranial, thoracic, abdominal). \n\n Patients with informed consent signed by them or their responsible relative. \n\n Patients who are likely to survive at least 48 hours after admission to the ICU. \n\n Patients who have measured baseline creatinine before UCI admission, in the last three months. \n\n ", - "exclusion_criteria": ": \n\n Patients who have contraindications for enteral medications. \n\n Patients who have acute kidney injury at the time of admission. \n\n Patients on renal replacement therapy prior to ICU admission. \n\n Patients with previous diagnosis of chronic kidney disease G3b stage. \n\n Patients with plasma potassium greater than 5.1mEq/L. \n\n Hypersensitivity to spironolactone. \n\n Septic shock. \n\n Obstructive uropathy. \n\n Renal transplantation. \n\n Postoperative period of nephrectomy. \n\n Pregnancy. \n\n Known adrenal insufficiency. \n\n Patients requiring a higher dose of norepinephrine 0.1mcg/kg/min for more than an hour to maintain mean arterial pressure equal to or greater than 70mmHg even after receiving fluid resuscitation. \n\n Patients requiring the administration of inhibitors of angiotensin-converting enzyme (ACE) for its management. \n\n Patients requiring an increase of 25% or more of the dose of norepinephrine to maintain mean arterial pressure equal of greater than 70mmHg during follow up.", - "brief_summary": "Acute kidney injury frequently affects cancer patients. The main cause of acute kidney injury is ischemic damage caused by transient decrease in renal blood flow, followed by blood flow restoration and accompanying reperfusion injury (ischemia-reperfusion injury. Several studies, mainly in animal models have tried to establish spironolactone role on kidney injury induced by ischemia-reperfusion injury. It has been demonstrated in renal transplant recipients that the administration of spironolactone can prevent oxidative stress and is safe. The group of cancer patients with states capable of producing tissue hypoperfusion (hypovolemic shock, heart failure, major surgery, use of anesthetics) are at increased risk of developing acute renal ischemia-reperfusion injury.~The investigators hypothesis is that spironolactone may be useful in preventing acute renal injury when administered during the first six hour of renal ischemia-reperfusion insult.~The purpose of this study is to determine the utility of spironolactone administered after an ischemic renal insult (major surgery) to prevent acute kidney injury in critically cancer patients.~Investigators propose a pilot study, randomized, double blind, placebo controlled trial, approved by the local ethical committee, to compare the efficacy of spironolactone to prevent acute kidney injury in patients after major surgery. Investigators will include 12 patients in spironolactone group (25mg daily for three days) and 12 patients in placebo group.", - "NCTID": "NCT02531412" - }, - { - "brief_title": "Plasma and Hemodynamic Markers During Hepatectomy", - "phase": "", - "drugs": "['Liver resection']", - "drugs_list": [ - "Liver resection" - ], - "diseases": "['Hepatorenal Syndrome, Liver Regeneration']", - "diseases_list": [ - "Hepatorenal Syndrome", - "Liver Regeneration" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient with neoplastic liver tumors undergoing elective hepatectomy. \n\n ", - "exclusion_criteria": ": \n\n Non elective hepatic surgery, preoperative HVPG > 10 mmHG, preoperative renal failure", - "brief_summary": "Introduction Liver resection is considered the only curative treatment option for mCRC patients without extrahepatic disease and is accepted practice. Despite substantial improvements in surgical techniques, postoperative morbidity and mortality remain an important concern after major resections. Complications of liver resection, although rare, include liver failure and acute kidney injury as indicated by oliguria and increased serum creatinine. The underlying pathophysiological pathways of post-operative renal alteration following liver resection is an increase in portal venous pressure, based on observations in animal models or small cohorts. The corpus of data is derived from patients with liver cirrhosis and subsequent hepatorenal syndrome. These data are limited since cirrhosis cannot distinguish between metabolic changes, portal hypertension and impaired liver function in the elucidation of the pathogenesis of renal alterations. Liver resection is therefore a potent model to evaluate the impact of portal hypertension on the kidney despite stable liver function.~The most significant factor determining morbidity and mortality following hepatectomy is the ability of the remnant liver to regenerate. In this context, several growth factors were shown to regulate the highly orchestrated process of liver regeneration (LR).~Hypothesis The investigators will therefore test the hypothesis that liver resection leads to a sustained increase of portalvenous pressure with a subsequent episode of oliguric renal impairment, correlating with the quantity of resected liver.~Furthermore, the investigators will examine the relationship between postoperative liver regeneration and circulating growth factor levels in patients undergoing hepatectomy. Based on the preclinical data the investigators hypothesize that a circulating growth factor levels will be associated with delayed liver regeneration, an increased incidence of postoperative liver dysfunction and concomitant worse clinical outcome.", - "NCTID": "NCT01700231" - }, - { - "brief_title": "Incidence, Risk Factors, and Risk Model of Acute Kidney Injury in Pediatric Patients Who Undergoing Surgery for Congenital Heart Disease", - "phase": "", - "drugs": "['surgery for congenital heart disease']", - "drugs_list": [ - "surgery for congenital heart disease" - ], - "diseases": "['Patients Undergoing Surgery for Congenital Heart Disease']", - "diseases_list": [ - "Patients Undergoing Surgery for Congenital Heart Disease" - ], - "enrollment": "220.0", - "inclusion_criteria": "inclusion criteria: \n\n patients who underwent surgery for congenital heart disease between January 2012 and December 2012 in Samsung Medical Center \n\n ", - "exclusion_criteria": ": \n\n incomplete data for creatinine, estimated glomerular filtration rate, or urine output required to diagnose acute kidney injury \n\n patients who expired within 24 hours after surgery", - "brief_summary": "Acute kidney injury (AKI) is a major complication after cardiac surgery and has been reported to be associated with adverse outcome. Previous studies have reported that the incidence of AKI in patients undergoing surgery for congenital heart disease is as high as 42% and AKI increase the patient mortality, intensive care unit stay and hospital stay. Previous studies have reported several risk factors for AKI after congenital heart surgery, however, perioperative variables including anesthesia-related factors have not been evaluated fully. Therefore, the investigators attempt to find out independent risk factors regarding perioperative variables.", - "NCTID": "NCT02081235" - }, - { - "brief_title": "Follow-up of AKI in Neonates During Childhood Years", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Neonatal Acute Kidney Injury', 'Childhood Chronic Kidney Disease']", - "diseases_list": [ - "Neonatal Acute Kidney Injury", - "Childhood Chronic Kidney Disease" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n Premature birth for Premature groups \n\n UVA NICU admission prior to 2 days of life \n\n Birth weight less than 1500 grams for premature groups \n\n Premature AKI Study group: Acute Kidney Injury as defined by KDIGO modified criteria during NICU stay at UVA \n\n Premature no AKI Control group: No AKI during NICU stay \n\n Term no AKI Control group: No AKI and born at term \n\n Parental or legal guardian consent obtained \n\n ", - "exclusion_criteria": ": \n\n - Patients with Congenital Anomalies of the Kidney and Urinary Tract", - "brief_summary": "The purpose of this study is to learn more about how to identify signs of early chronic kidney diseases in children who were born prematurely with low birth weight (less than 3 \u00bd pounds). Researchers plan to compare the kidney function in children who experienced acute kidney injury (AKI) in the Neonatal Intensive Care Unit (NICU) with those who did not experience it. Evidence from several studies and our experience at UVA show that older children who experienced AKI while in the Pediatric Intensive Care Unit (PICU) have increased risk of developing early chronic kidney disease, and they also show early changes in the urine and blood that is consistent with early chronic kidney disease. In this study, the investigators hope to determine if any of these changes can be detected in early childhood, and if so, at what age we can start detecting these changes.", - "NCTID": "NCT02306642" - }, - { - "brief_title": "Predicting Acute Kidney Injury After Coronary Artery Bypass Graft", - "phase": "", - "drugs": "['Coronary artery bypass surgery']", - "drugs_list": [ - "Coronary artery bypass surgery" - ], - "diseases": "['Coronary Artery Bypass Surgery', 'Acute Kidney Injury', 'Creatinine', 'Mortality']", - "diseases_list": [ - "Coronary Artery Bypass Surgery", - "Acute Kidney Injury", - "Creatinine", - "Mortality" - ], - "enrollment": "877.0", - "inclusion_criteria": "inclusion criteria: \n\n patients who underwent coronary artery bypass surgery during between 2010 and 2012 in Samsung Medical Center \n\n ", - "exclusion_criteria": ": \n\n lack of postoperative creatinine or urine output data \n\n patients who expired within 24hours after surgery", - "brief_summary": "Acute kidney injury after cardiac surgery is a major complication after cardiac surgery and has been reported to be associated with adverse outcome. There have been many studies reporting risk factor of acute kidney injury after cardiac surgery, but the influence of perioperative variables related to anesthesia and perioperative medication has not been evaluated fully. The investigators attempt to evaluate the influence of perioperative clinical variables including preoperative medication, preoperative albumin level, uric acid concentration, anesthesia technique, use of hydroxyethyl starch, blood glucose level, intraoperative medication, perioperative cardiac function (systolic and diastolic function) and hemodynamic variables during surgery on the incidence of acute kidney injury after coronary artery bypass graft.", - "NCTID": "NCT02081261" - }, - { - "brief_title": "Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery", - "phase": "", - "drugs": "['minocycline', 'placebo']", - "drugs_list": [ - "minocycline", - "placebo" - ], - "diseases": "['Kidney Failure, Acute', 'Acute Kidney Insufficiency']", - "diseases_list": [ - "Kidney Failure", - "Acute", - "Acute Kidney Insufficiency" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Age over 18 years \n\n planned CABG or valvular surgery with cardiopulmonary bypass \n\n Serum creatinine available (within 30 days) \n\n Estimated GFR 15-90ml/min using the abbreviated MDRD formula (CKD stages 2-4) \n\n ", - "exclusion_criteria": ": \n\n Emergent or urgent surgery (to be performed within the next 36 hours) \n\n End stage renal disease, or GFR < 15ml/min (CKD stage 5) \n\n Estimated GFR>90ml/min (CKD stage 1 or no CKD) \n\n Ongoing infection by positive blood, urine or sputum cultures or pneumonia on CXR \n\n Allergy to minocycline or tetracyclines \n\n inability to take oral medications \n\n use of preoperative vasopressor agents at therapeutic doses \n\n Pregnant or lactating females \n\n Advanced liver disease by history or exam(cirrhosis, ascitis, jaundice) \n\n Rising creatinine meeting the definition of acute kidney injury prior to surgery \n\n Neurologic signs or symptoms or history of increased intracranial pressure \n\n current participation in another research study involving an investigational drug or device", - "brief_summary": "This study proposes to investigate whether treatment with minocycline pre-operatively in patients with mild to moderate chronic kidney disease undergoing cardiac surgery will reduce the occurence of kidney injury.", - "NCTID": "NCT00556491" - }, - { - "brief_title": "Study of Intravenous Amino Acid Infusion to Prevent Contrast Dye Mediated Renal Damage", - "phase": "Phase 2", - "drugs": "['Amino Acid', 'Placebo']", - "drugs_list": [ - "Amino Acid", - "Placebo" - ], - "diseases": "['Contrast Nephropathy', 'Renal Failure']", - "diseases_list": [ - "Contrast Nephropathy", - "Renal Failure" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Greater then 18 years of age \n\n Referral for coronary angiography \n\n Type 1 or type 2 diabetic requiring insulin or oral hypoglycemic agents \n\n Stable serum creatinine concentration (140 to 300 \u03bcmol per liter for men or 125 to 300 \u03bcmol per liter for women or a creatinine clearance not greater than 60 ml/min (as calculated by Cockcroft-Gault equation) \n\n Non diabetic subjects with a stable serum creatinine concentration of 160 to 300 \u00b5mol per liter for men and 140 to 300 \u00b5mol per liter for women. \n\n Stable renal function defined as no documented rise or fall in serum creatinine by more then 44 umol/L in the preceding 2 weeks \n\n ", - "exclusion_criteria": ": \n\n Refusal or inability to give consent \n\n Pregnant \n\n Non-elective coronary angiography \n\n Recent administration (within 21 days) of iodinated intravenous contrast dye \n\n Recent administration (within 21 days) of non-steroidal anti-inflammatory drugs (excluding aspirin), aminoglycoside antibiotics or chemotherapeutic agents \n\n Severe/unstable diabetics requiring emergency room or inpatient therapy in the previous 21 days \n\n Compensated or decompensated hepatic failure \n\n Renal transplant", - "brief_summary": "Exposure to radiographic contrast dye during coronary angiography is well known to cause either transient decreases in renal function or acute renal failure. Although the overall incidence is low, acute renal failure occurs most frequently in patients with both diabetes and chronic renal failure where the average reported incidence is upwards of 20%. The etiology of contrast-induced nephropathy is related to acute decline in renal blood flow following dye exposure resulting in ischemic injury at the level of the medulla. The development of acute renal failure following radiocontrast dye administration is significant because it contributes to morbidity and mortality in patients at risk.~The administration of amino acids, either through intravenous infusion or a protein meal, results in a substantial increase in renal plasma flow (RPF) and glomerular filtration rate (GFR). In both healthy subjects and in those with chronic renal failure, an amino acid infusion produces a 20% rise in GFR and effective RPF.~We hypothesize that the 20% rise in effective RPF and GFR following an amino acid infusion will counteract the radiocontrast dye-induced vasoconstriction and reduce the renal toxicity of contrast medium in a group of high-risk patients.", - "NCTID": "NCT00313807" - }, - { - "brief_title": "A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin", - "phase": "Phase 3", - "drugs": "['Terlipressin', 'Placebo']", - "drugs_list": [ - "Terlipressin", - "Placebo" - ], - "diseases": "['Hepatorenal Syndrome']", - "diseases_list": [ - "Hepatorenal Syndrome" - ], - "enrollment": "196.0", - "inclusion_criteria": "inclusion criteria: \n\n Written informed consent by subject or legally authorized representative \n\n At least 18 years of age \n\n Cirrhosis and ascites \n\n Rapidly progressive reduction in renal function characterized by: \n\n Serum creatinine (SCr) \u2265 2.5 mg/dL \n\n Doubling of SCr within 2 weeks (or for observations of shorter duration, SCr values over time meeting slope-based criteria for proportional increases likely to be representative of at least a doubling within 2 weeks \n\n No sustained improvement in renal function (< 20% decrease in SCr and SCr \u2265 2.25 mg/dL) 48 hours after both diuretic withdrawal and the beginning of plasma volume expansion with albumin: \n\n Note: Albumin doses recommended by the International Ascites Club (IAC) are 1 g/kg on the first day (Maximum 100 g) and 20 - 40 g/day thereafter as clinically indicated. It is recommended (if clinically appropriate) that the albumin dose is kept constant during the study drug administration period. \n\n Note: The qualifying SCr value is the SCr value at least 48 hrs after both diuretic withdrawal (if applicable) and the beginning of albumin fluid challenge. The qualifying SCr value must be \u2265 2.25 mg/dL AND at least 80% of the diagnostic (pre-fluid challenge) SCr value. \n\n ", - "exclusion_criteria": ": \n\n SCr > 7 mg/dL \n\n Shock Note: Hypotension (Mean Arterial Pressure < 70 mm Hg or a decrease > 40 mm Hg in systolic blood pressure from baseline) with evidence of hypoperfusion abnormalities despite adequate fluid resuscitation. \n\n Sepsis or systemic inflammatory response syndrome (SIRS) \n\n Note: SIRS: Presence of 2 or more of the following findings: \n\n Temperature > 38\u00b0C or < 36\u00b0C; heart rate > 90/min; respiratory rate of > 20/min or a PaCO2 of < 32 mm Hg; white blood cell count of > 12,000 cells/\u00b5L or < 4,000/ \u00b5L. \n\n Note: Sepsis: Documented infection and systemic inflammatory response syndrome. \n\n < 2 days anti-infective therapy for documented or suspected infection \n\n Proteinuria > 500 mg/day \n\n Hematuria or microhematuria (> 50 red blood cells per high power field) \n\n Clinically significant casts on urinalysis, including granular casts Note: Urine sediment examination is required to exclude presence of granular casts and other clinically significant casts [e.g., red blood cell (RBC) casts]. \n\n Evidence of intrinsic or parenchymal renal disease (including acute tubular necrosis) \n\n Obstructive uropathy or other renal pathology on ultrasound or other medical imaging \n\n Current or recent treatment (within 4 weeks) with nephrotoxic drugs, e.g., aminoglycosides, nonsteroidal anti-inflammatory drugs (NSAID) Note: Up to 3 doses of an NSAID within the prior month (prescription or over the counter) is acceptable Note: Use of short-term (< 2 weeks) oral neomycin for acute encephalopathy is acceptable. \n\n Current or recent (within 4 weeks) renal replacement therapy \n\n Superimposed acute liver failure/injury due to factors other than alcoholic hepatitis, including acute viral hepatitis, drugs, medications (e.g., acetaminophen), or other toxins (e.g., mushroom [Amanita] poisoning) \n\n Current or recent treatment (within 48 hours) with octreotide, midodrine, vasopressin, dopamine or other vasopressors \n\n Severe cardiovascular disease as judged by investigator \n\n Estimated life expectancy of less than 3 days \n\n Confirmed pregnancy \n\n Known allergy or sensitivity to terlipressin or another component of the study treatment \n\n Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization", - "brief_summary": "This study is designed to evaluate the efficacy and safety of intravenous terlipressin versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in participants receiving standard of care albumin therapy.", - "NCTID": "NCT01143246" - }, - { - "brief_title": "Usefulness of Neutrophil Gelatinase-associated Lipocalin(NGAL) to Confirm Acute Kidney Function Decrease of the Patients Who Had Non-cardiac Surgery", - "phase": "", - "drugs": "['The level of NGAL after pre op,post op 4hr, post op 12hr']", - "drugs_list": [ - "The level of NGAL after pre op,post op 4hr", - "post op 12hr" - ], - "diseases": "['Chronic Kidney Disease']", - "diseases_list": [ - "Chronic Kidney Disease" - ], - "enrollment": "43.0", - "inclusion_criteria": "inclusion criteria: \n\n 43 patients who had non-cardiac surgery in Seoul Paik Hospital. \n\n ", - "exclusion_criteria": ": \n\n have viral hepatitis and Aspartate aminotransferase, Alanine aminotransferase > 2 time of normal level \n\n severe lung disease \n\n severe heart failure ( Ejection Fraction < 40% ) \n\n pregnancy", - "brief_summary": "Although post-op renal function decrease is determined by serum creatinine, serum creatinine has disadvantages that it increases a long time after renal function decrease and it has various increasing time based on the level of renal function. Neutrophil Gelatinase-associated Lipocalin (NGAL's) usefulness as an evidence for acute kidney damage occurring from post-op cardiac surgery, being critical patients and contrast medium use is already proven.~But NGAL's usefulness for renal function after non-cardiac surgery is not proven and especially, NGAL's usefulness for renal injury after non-cardiac surgery in chronic renal disease patients is not proven.Therefore, the investigators will study about renal function decrease after non-cardiac surgery with NGAL and serum creatinine.", - "NCTID": "NCT02233010" - }, - { - "brief_title": "Seattle Cardiorenal Remote Ischemic Preconditioning Trial", - "phase": "", - "drugs": "['RIPC', 'Control']", - "drugs_list": [ - "RIPC", - "Control" - ], - "diseases": "['Congenital Heart Disease', 'Cardiopulmonary Bypass', 'Myocardial Injury', 'Acute Kidney Injury', 'Acute Lung Injury']", - "diseases_list": [ - "Congenital Heart Disease", - "Cardiopulmonary Bypass", - "Myocardial Injury", - "Acute Kidney Injury", - "Acute Lung Injury" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria: \n\n Age birth to 18 years Cardiac surgery with planned cardiopulmonary bypass \n\n ", - "exclusion_criteria": ": \n\n Any contraindication to compression of lower extremity/extremities Body weight <2 kg Active infection going into surgery On renal replacement therapy (RRT) or mechanical circulatory support going into surgery On inotropic support going into surgery", - "brief_summary": "Remote Ischemic Preconditioning (RIPC) is a treatment that may be associated with improved outcomes after cardiac surgery. It can be elicited noninvasively by using a tourniquet to elicit transient ischemia over a lower extremity. It is thought to promote anti-inflammatory and cell survival pathways, and thus protect remote organs against future ischemic injury. We hypothesize that compared to sham treatment, RIPC will be associated with decreased post-operative acute kidney, myocardial, and lung injury.", - "NCTID": "NCT01260259" - }, - { - "brief_title": "Inflammatory and Immune Profiling of Kidney Tissue Obtained From Patients With Newly Diagnosed Kidney Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Proteinuria', 'Kidney Injury', 'Chronic Kidney Disease']", - "diseases_list": [ - "Proteinuria", - "Kidney Injury", - "Chronic Kidney Disease" - ], - "enrollment": "119.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and females, 18 years to 90 years old \n\n Any subject with pre-existing clinical indication of a kidney biopsy including, but not limited to, nephritic syndrome, nephritic syndrome or proteinuric disease state. Additionally, kidney transplant donors will be included for purpose of obtaining control tissue. \n\n Willing and able to give consent \n\n Additionally, kidney transplant donors and patients requiring nephrectomy for removal of renal mass will be included for purpose of obtaining control tissue. \n\n ", - "exclusion_criteria": ": \n\n Subjects on longstanding immunosuppressive agents (empiric initiation of glucocorticoid therapy within 48 hours prior to kidney biopsy is acceptable) \n\n Kidney transplant recipient \n\n Inability to follow-up for future protocol laboratory evaluation", - "brief_summary": "This study will evaluate in patients with kidney disease, the role that certain inflammatory and immune mediators play in promoting kidney damage. The investigators hypothesize that certain mediators, (identified in the serum, urine and renal biopsy tissue), of patients with a variety of different renal disease states will provide information regarding their clinical course and that inflammatory and immune patterns in the serum and urine of patients with kidney disease may yield predictive diagnostic information in place of a renal biopsy. The ability to detect and quantify these mediators may lead to earlier detection and treatment of kidney disease in order to prevent kidney failure and the requirement for renal replacement.~The study will evaluate serum, blood and urine collected over a one year period post kidney biopsy for the presence of inflammatory or immune mediators, which will be correlated with kidney pathology findings (gene signatures). These gene signatures will be compared to normal control specimens obtained from donor transplant kidneys or from normal kidney tissue obtained from patients who require their entire kidney removed for a tumor.", - "NCTID": "NCT01156428" - }, - { - "brief_title": "Delayed Renal Allograft Function and Furosemide Treatment", - "phase": "Phase 2", - "drugs": "['Furosemide', 'Placebo']", - "drugs_list": [ - "Furosemide", - "Placebo" - ], - "diseases": "['Delayed Graft Function']", - "diseases_list": [ - "Delayed Graft Function" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 18 years \n\n Patient with ESRD who has been on RRT (Hemodialysis or Peritoneal dialysis) \n\n Recipient of deceased donor kidney transplant \n\n Urine output less than 0.5 mL/kg/h before transplant \n\n Patient consents to the study \n\n Patient is not allergic to furosemide or sulfa \n\n English or Spanish speaking patient \n\n Patient is oliguric (urine output less than 0.5mL/kg/h, as per AKIN criteria) or anuric (urine output less than 10 mL in 6 hours post-transplant or 2 mL/h) in the first 6 hours post kidney transplant \n\n ", - "exclusion_criteria": ": \n\n Recipients of a living donor kidney transplant \n\n Patients who do not consent for the study \n\n Patients age <18 years \n\n Patients who are allergic to furosemide or sulfa containing medications \n\n Non-oliguric patients \n\n Patients who require immediate dialysis within 6 hours of the transplant (before enrollment) \n\n Patients with renal ischemia due to vascular compromise that has been confirmed with Doppler Ultrasound right after transplant as per standard of care \n\n Patients who return to the operating room due to complications within 24 hours \n\n Simultaneous multi-organ transplant recipients \n\n Hypotensive patients with BP <90/60 or MAP <60 mmHg \n\n Patients who are on vasopressors at any time during study period \n\n Non-English or Spanish speaking patient", - "brief_summary": "This study will be a randomized prospective double-blind placebo-controlled clinical pilot trial. This will be a single center project that will take place at Loma Linda University Medical Center. All adult kidney recipients will be informed of the study prior to operation. The Nephrology fellows or attending physicians will attempt to obtain informed consent from all eligible patients, pre-transplant. Those patients who consent will be screened post operation for enrollment. Patients who do not meet all eligibility criteria and/or who meet some exclusion criteria will be deemed ineligible for the trial, and will be excluded. The Nephrology and Transplant teams will be blinded of patient assignment and only the pharmacy will know the patient's assignment.", - "NCTID": "NCT02312115" - }, - { - "brief_title": "Sodium Supplementation and Growth in Very Low Birth Weight Infants", - "phase": "Phase 4", - "drugs": "['Sodium chloride', 'Placebo']", - "drugs_list": [ - "Sodium chloride", - "Placebo" - ], - "diseases": "['Extreme Immaturity']", - "diseases_list": [ - "Extreme Immaturity" - ], - "enrollment": "53.0", - "inclusion_criteria": "inclusion criteria: \n\n infants born at less than 32 weeks postmenstrual age \n\n ", - "exclusion_criteria": ": \n\n infants with major malformations deemed incompatible with life disease states characterized by edema renal failure, defined as an increase in serum creatinine by 0.5 mg/dl/day or urine output less than 0.5 ml/kg/hour", - "brief_summary": "Adequate growth during the neonatal period is critical for optimal long term outcomes. Despite maximal calorie intake, sixty percent of very low birth weight infants still fail to thrive suggesting that factors other than total calorie intake are important in ensuring consistent weight gain. Several reports have indicated a positive sodium balance is critical in ensuring good weight gain in very low birth weight infants, however these infants are susceptible to low serum sodium concentrations. Urine sodium values are sometimes used to diagnosis of hyponatremia or negative sodium balance after the first two weeks of life, but there is no evidence for this practice in preterm neonates. Our central hypothesis is that early supplementation with sodium will ensure positive sodium balance in very low birth weight infants and will result in optimal weight gain and enhanced long term outcomes. Secondarily we hypothesize that low sodium concentrations in the urine will not correlate with low serum sodium values.", - "NCTID": "NCT01795638" - }, - { - "brief_title": "Phase I Study of Alpha-Melanocyte Stimulating Hormone in Patients With Acute Renal Failure", - "phase": "Phase 1", - "drugs": "['alpha-melanocyte stimulating hormone']", - "drugs_list": [ - "alpha-melanocyte stimulating hormone" - ], - "diseases": "['Acute Renal Failure']", - "diseases_list": [ - "Acute Renal Failure" - ], - "enrollment": "45.0", - "inclusion_criteria": "PROTOCOL ENTRY CRITERIA: \n\n --Disease Characteristics-- \n\n Group 1: Patients on chronic hemodialysis \n\n Group 2: Patients at high risk of developing acute renal failure (ARF) after cadaveric renal transplantation Received high risk allograft Cadaveric kidneys with greater than 24 hours of cold ischemia time Donor had rising creatinine before organ procurement Donor over 60 years \n\n Group 3: Patients with ischemic ARF due to hypotension, surgery, or trauma ARF severity index 20-60% Creatinine clearance 12-14 mL/min Rising creatinine of at least 0.5 mg/dL per day for 2 days without evidence of recovery despite standard supportive care No drug or contrast induced renal failure No oliguric renal failure (creatinine clearance 3-4 mL/min) No prior chronic renal failure Baseline creatinine greater than 2.5 mg/dL (males) or 2.0 mg/dL (females) No ARF due to bacterial or fungal sepsis, nephrotoxins, acute tubulointerstitial nephritis, cyclosporine toxicity, bilateral renal vascular disease, or systemic diseases (hepatorenal syndrome, glomerulonephritis, renal vasculitis, etc.) \n\n --Prior/Concurrent Therapy-- \n\n Group 1: No recent immunosuppressive therapy Group 2 and 3: No prior renal transplantation No prior alpha-MSH Group 3: No prior dialysis for this episode of ARF No anticipated need for dialysis for at least 24 hours At least 12 hours since prior diuretics, mannitol, or dopamine At least 14 days since prior immunosuppressive drugs \n\n --Patient Characteristics-- \n\n No recent infection No known reaction to Terumo T175 dialyzer Not a prisoner Not pregnant or nursing No allergy to drugs used in study Not mentally impaired Group 3: No severe nonrenal medical condition that would interfere with the study (e.g., terminal cancer)", - "exclusion_criteria": "", - "brief_summary": "OBJECTIVES: I. Determine the maximum tolerated dose and safety of alpha-melanocyte stimulating hormone (alpha-MSH) in patients with acute renal failure.~II. Determine the safety and pharmacokinetics of alpha-MSH in patients at high risk of acute renal failure after renal transplantation.~III. Determine the safety and pharmacokinetics of alpha-MSH in patients with established ischemic acute renal failure.~IV. Determine the effect of alpha-MSH on interleukin-10 pharmacokinetics.", - "NCTID": "NCT00004496" - }, - { - "brief_title": "Paracetamol Effect on Oxidative Stress and Renal Function in Severe Malaria", - "phase": "", - "drugs": "['Paracetamol', 'No Paracetamol']", - "drugs_list": [ - "Paracetamol", - "No Paracetamol" - ], - "diseases": "['Malaria']", - "diseases_list": [ - "Malaria" - ], - "enrollment": "62.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient age >12 years \n\n Presence of severe or moderately severe P. falciparum malaria, with and without blackwater fever, confirmed by positive blood smear with asexual forms of P. falciparum \n\n Temperature >38 degrees Celsius on admission or fever during the preceding 24hours \n\n Written informed consent from patient or attending relative able to and willing to give informed consent. Consent form and information sheets will be translated into Bangla and copies provided to the patient. \n\n ", - "exclusion_criteria": ": \n\n Patient or relatives unable or unwilling to give informed consent \n\n History of chronic liver disease \n\n History of alcohol use (>3drinks per day) \n\n Contraindication or allergy to paracetamol or artesunate therapy \n\n Contraindication to nasogastric tube insertion i.e. facial fracture, bleeding diathesis \n\n Pregnancy", - "brief_summary": "Blackwater fever, characterized by intravascular haemolysis and hemoglobinuria, is an important cause of renal impairment and mortality in severe malaria caused by Plasmodium falciparum. The largest malaria clinical trials report blackwater incidences of 5-7% in Asian adults and 4% in African children with severe malaria treated with artesunate or quinine. The prevalence of blackwater fever in Chittagong, Bangladesh is 15% with associated rates of renal failure and mortality of 42.9% and 14.2% respectively.~The fundamental characteristic of blackwater fever is the presence of intravascular hemolysis of both infected and uninfected erythrocytes and release of free haemoglobin. The cytotoxic free haemoglobin present can cause severe oxidative damage as a result of haem redox cycling yielding ferric and ferryl heme, which generate radical species that induce lipid peroxidation and subsequent production of F2-isoprostanes (F2-IsoPs). Evidence suggests that F2-IsoPs generated by the hemoprotein-catalyzed oxidation of lipids are responsible for the oxidative damage and vasoconstriction associated with renal injury in haemolytic disorders and rhabdomyolysis.~A novel mechanism of paracetamol was recently demonstrated, showing that paracetamol is a potent inhibitor of hemoprotein-catalyzed lipid peroxidation by reducing ferryl heme to its less toxic ferric state and quenching globin radicals. In a recent proof of concept trial, paracetamol at therapeutic levels was shown to significantly decrease oxidant kidney injury, improve renal function and reduce renal damage by inhibiting the hemoprotein-catalyzed lipid peroxidation in a rat model of rhabdomyolysis-induced renal injury. Since adults with severe malaria demonstrate increased concentrations of cell-free haemoglobin, and urinary F2-IsoPs, the investigators hypothesize that this novel inhibitory mechanism of paracetamol may provide renal protection in this population by reducing the hemoprotein-induced lipid peroxidation. As there is currently no consensus that exists concerning adequate medical treatment for blackwater fever, the potential application of this safe and extensively used drug would be of great benefit.", - "NCTID": "NCT01641289" - }, - { - "brief_title": "A Comparison of Propofol Based Total Intravenous Anesthesia and Desflurane Based Balanced Anesthesia on Renal Protection During Deceased Brain Dead Donor Kidney Transplantation - A Prospective, Randomized Trial", - "phase": "Phase 4", - "drugs": "['Desflurane balanced anesthesia', 'Propofol total intravenous anesthesia']", - "drugs_list": [ - "Desflurane balanced anesthesia", - "Propofol total intravenous anesthesia" - ], - "diseases": "['End Stage Renal Disease']", - "diseases_list": [ - "End Stage Renal Disease" - ], - "enrollment": "6.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult deceased brain dead kidney donors and recipients scheduled for renal transplantation \n\n ", - "exclusion_criteria": ": \n\n 1. Donor ", - "brief_summary": "Renal ischemia/reperfusion (I/R)-induced injury is known to be associated with immediate and long-term kidney dysfunction after renal transplantation. Protecting the kidney against I/R injury and maintaining renal function during renal transplant surgery is therefore very important in order to improve post-operative outcome. This purpose of this study is to investigate whether propofol anesthesia done in both kidney donors and recipients during deceased brain dead donor kidney transplantation is effective in reducing renal I/R injury via its antioxidant and antiinflammatory properties and improve post-transplant outcome compared to desflurane anesthesia.", - "NCTID": "NCT01870011" - }, - { - "brief_title": "Bioequivalence Study of Hydrochlorothiazide 50mg Tablets Under Fasting Conditions", - "phase": "", - "drugs": "['hydrochlorothiazide 50 mg tablet']", - "drugs_list": [ - "hydrochlorothiazide 50 mg tablet" - ], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "36.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged 18-45 years. \n\n Were neither overweight nor underweight for his height as per the Life Insurance Corporation of India height/weight chart for non-medical cases. \n\n Had voluntarily given written informed consent to participate in this study. \n\n Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study. \n\n ", - "exclusion_criteria": ": \n\n - Had history of allergy or hypersensitivity to hydrochlorothiazide or any other sulphonamide derived drugs. \n\n Had history of diarrhoea, vomiting or headache within past two weeks \n\n Had history of hypotension (systolic BP<100 mmHg) \n\n Had history of allergy or bronchial asthma \n\n Had history of muscle cramps or muscle weakness \n\n Had history of any anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura, Systemic Lupus Erythematoses(SLE) \n\n Had history of aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia \n\n Had history of anuria or history/evidence of any renal disorder including renal failure, renal dysfunction, interstitial nephritis. \n\n Had history of erythema multiforme including Stevens- Johnson syndrome or exfoliative dermatitis including toxic epidermal necrolysis \n\n Had history of pancreatitis \n\n Had history/evidence of jaundice or any hepatic or gall bladder disease \n\n Had history of hyperglycemia, glycosuria, hyperuricemia or gout. \n\n The subject had a history/evidence of any electrolyte imbalance, serum sodium < 135 mEq/L, serum potassium < 3.5 mEq/ L. \n\n Had any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations. \n\n Had presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection. \n\n Had presence of values, which are significantly different from normal, reference and/or judged clinically significant for haemoglobin, total white blood cells count, differential WBC count or platelet count. \n\n Had positive for urinary screen testing of drugs of abuse (opiates or cannabinoids) \n\n Had presence of values, which are significantly different from normal, reference ranges and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol. \n\n Had clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), epithelial cells (>4/HPF), glucose (positive) or protein (positive). \n\n Had clinically abnormal ECG or Chest X-ray. \n\n Had history of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma. \n\n Had history of any psychiatric illness, which may impair the ability to provide, written informed consent. \n\n Were regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period. \n\n Had history of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or have difficulty in abstaining for the duration of each study period. \n\n Had used any enzyme modifying drugs within 30 days prior to Day 1 of this study. \n\n Had participated in any clinical trial within 12 weeks preceding Day 1 of this study. \n\n Subjects who, through completion of this study, would have donated and/or lost more than 350 mL of blood in the past 3 months.", - "brief_summary": "To compare the single-dose oral bioavailability of hydrochlorothiazide 50 mg tablet of Ohm Laboratories (A subsidiary of Ranbaxy pharmaceuticals USA) with hydrochlorothiazide 50 mg tablet of IVAX Pharmaceuticals, USA in healthy, adult, human, male subjects under fasting condition", - "NCTID": "NCT00776646" - }, - { - "brief_title": "Influence of Tidal Volume During Mechanical Ventilation on Postoperative Clinical Outcome in Pediatric Patients Undergoing Congenital Heart Surgery", - "phase": "", - "drugs": "['Surgery for congenital heart disease']", - "drugs_list": [ - "Surgery for congenital heart disease" - ], - "diseases": "['Patients Who Underwent Surgery for Congenital Heart Disease']", - "diseases_list": [ - "Patients Who Underwent Surgery for Congenital Heart Disease" - ], - "enrollment": "1000.0", - "inclusion_criteria": "inclusion criteria: \n\n pediatric patients who underwent surgery for congenital heart disease with cardiopulmonary bypass between 2009 and 2013 in Samsung Medical Center \n\n ", - "exclusion_criteria": ": \n\n patients who lack data regarding mortality, creatinine, estimated glomerular filtration rate, or urine output.", - "brief_summary": "High tidal volume during mechanical ventilation has been reported to increase mortality in patients with acute lung injury or acute respiratory distress syndrome. High tidal volume was also reported to be associated with increased mortality in adult patients without acute lung injury or acute respiratory distress syndrome. However, the influence of high tidal volume on clinical outcome in pediatric patients who underwent surgery for congenital heart disease has not been evaluated yet. The investigators attempted to evaluate the effect of tidal volume on clinical outcome in both cyanotic and non-cyanotic congenital heart disease.", - "NCTID": "NCT02081274" - }, - { - "brief_title": "Screening and Identification of Human Urate Transporter hURAT1 MicroRNA", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Urinary Calculi']", - "diseases_list": [ - "Urinary Calculi" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n A\u3001B group were enrolled standards: \u2460 aged 18-65 years old; \u2461 comply with percutaneous nephrolithotomy lithotripsy indications for surgery; \u2462 ECT tips ipsilateral normal or mildly impaired renal function. \n\n Group C patients were enrolled standards: \u2460 aged 18-65 years old; \u2461 normal renal function, not associated with urinary calculi in patients; \u2462 cancer patients met radical nephrectomy indications for surgery; \u2463 emergency trauma patients suffering from kidney resection surgical indications. \n\n ", - "exclusion_criteria": ": \n\n aged <18 years or> 65 years; \u2461 neurological disease or cognitive dysfunction; \u2462 can not be corrected or uncorrected coagulopathy; \u2463 associated with diabetes, hypertension and other metabolic diseases; \u2464 accompanied by tuberculosis, hepatitis, HIV and other infectious diseases; \u2465 poor tolerance to anesthesia and surgery, such as: severe cardiopulmonary disease, coagulation disorders, etc.; \u2466 ultrasound, renal imaging examination revealed renal cortex was significantly thinner (renal cortical thickness <1.5cm), structural variation; \u2467 with severe systemic or urinary tract infection; \u2468 ECT tips ipsilateral renal function is severely impaired or solitary kidney.", - "brief_summary": "This study intends to use in patients with renal tissue and blood samples, screening and identification of renal tissue hURAT1 regulating the expression of micro-RNA, for further study of uric acid stone formation mechanism and the occurrence of clinical preventive uric acid stones provide new clues and new intervention targets.", - "NCTID": "NCT01973088" - }, - { - "brief_title": "Defining Normal Citrulline Levels as a Diagnostic Tool for Screening of Gastrointestinal Disease in Premature Infants", - "phase": "", - "drugs": "['Citrulline samples']", - "drugs_list": [ - "Citrulline samples" - ], - "diseases": "['Premature Newborn', 'Necrotizing Enterocolitis']", - "diseases_list": [ - "Premature Newborn", - "Necrotizing Enterocolitis" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n 1. Premature infants with gestational age between <32 weeks regardless of birth weight \n\n ", - "exclusion_criteria": ": \n\n Inborn errors of metabolism \n\n Need for exchange transfusion \n\n Multiple congenital anomalies \n\n Renal failure (defined as urine output <1ml/k/h >24h, creatinine >1.8, or diagnosis of non-oliguric renal failure as determined by Pediatric nephrology)", - "brief_summary": "Since the first description of citrulline as a potential marker for intestinal function in 1998, its use has been investigated in a variety of disease processes including Short Bowel Syndrome, Celiac disease, chemotherapy and radiation induced intestinal injury, infections producing intestinal cytopathic effects like Adenovirus, and predicting rejection in intestinal transplantation. The use of citrulline levels as a diagnostic tool to predict gastrointestinal disease in the premature population has not been properly addressed.~The introduction of enteral nutrition in the premature infant is a process of trial and error, knowing that the immaturity of the gastrointestinal system may lead to frequent episodes of feeding intolerance. This is augmented by the fear of the development of necrotizing enterocolitis (NEC) once feeds are commenced. NEC is a condition characterized by disruption of the intestinal epithelial barrier, a pathogenic process shared with some of the conditions mentioned above for which citrulline has proven clinically useful.~A normal pattern of citrulline production has not been established in the premature population. Previous studies have shown decreased levels of glutamine and arginine in premature infants up to 10 days prior to the development of necrotizing enterocolitis. Glutamine and arginine are two amino acids closely involved in the synthesis and catabolism of citrulline.~The investigators therefore hypothesize that defining a normal pattern of citrulline production in the premature population may prove to be a clinically useful diagnostic tool to screen for gastrointestinal disease.", - "NCTID": "NCT01062828" - }, - { - "brief_title": "Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy", - "phase": "", - "drugs": "['enalapril']", - "drugs_list": [ - "enalapril" - ], - "diseases": "['IGA Glomerulonephritis']", - "diseases_list": [ - "IGA Glomerulonephritis" - ], - "enrollment": "43.0", - "inclusion_criteria": "Histologically confirmed IgA nephropathy, diagnosed within the past 3 years \n\n Clinical presentation of either isolated hematuria/proteinuria for less than 3 years OR \n\n Acute nephritic or nephrotic syndrome \n\n No secondary forms of IgA nephropathy associated with chronic inflammatory disease of the bowel and liver \n\n No end stage renal failure as defined by the following: Glomerular filtration rate less than 15 mL/min AND Extensive glomerulosclerosis and tubulointerstitial damage \n\n No systemic lupus erythematosus or systemic (extrarenal) vasculitis (Henoch-Schonlein syndrome) \n\n Healthy volunteers will be accrued as a control group \n\n No other concurrent medical or psychiatric illness that would preclude study", - "exclusion_criteria": "", - "brief_summary": "OBJECTIVES: I. Determine the most sensitive outcome measures (functional or morphological) of a progressive renal injury in patients with IgA nephropathy.~II. Determine which of these patients are destined to progress to further injury in order to target them for therapy.~III. Elucidate the determinants of progression in those patients who exhibit evidence of either increasing impairment of ultrafiltration capacity or ongoing destruction of nephrons.", - "NCTID": "NCT00006137" - }, - { - "brief_title": "Evaluation of a Novel Electronic Urine Output Monitor (eUOM)", - "phase": "", - "drugs": "['Accuryn']", - "drugs_list": [ - "Accuryn" - ], - "diseases": "['Oliguria', 'Polyuria']", - "diseases_list": [ - "Oliguria", - "Polyuria" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient must \u2265 18 years of age \n\n Patient has a Foley catheter and urine collection system is in place per standard clinical decision \n\n Estimated length of placement of the Foley is 48 hours minimum \n\n Burn injury \u2265 20% and \u2264 80% total body surface area (TBSA) \n\n Subject or subject's legally authorized representative is able to give informed consent before entering the study \n\n ", - "exclusion_criteria": ": \n\n Currently pregnant or breastfeeding \n\n Clinical signs or symptoms of a urinary tract infection (UTI) \n\n Clinical signs or symptoms of a vaginal infection \n\n Currently has bladder or urethral trauma \n\n Use of investigational drug/device therapy within the past 4 weeks", - "brief_summary": "Urine output and urine drain line pressure were monitored while urine was drained into either:~Accuryn Urine Output Monitor (Potrero Medical) OR~Criticore Monitor (Bard Medical)", - "NCTID": "NCT02195713" - }, - { - "brief_title": "The Circadian Rhythm of Urine Output in Healthy Infants", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy children, free of medication \n\n ", - "exclusion_criteria": ": \n\n History of urinary diseases", - "brief_summary": "The purpose of this study is to describe the 24-hour urine output including the urinary excretion of hormones, electrolytes and other osmotically active substances in healthy children age 0 to 3 years old.", - "NCTID": "NCT00232401" - }, - { - "brief_title": "Bioequivalence Study of Felodipine ER Tablets 10 mg Under Fed Conditions", - "phase": "", - "drugs": "['Felodipine', 'Felodipine (Plendil\u00ae)']", - "drugs_list": [ - "Felodipine", - "Felodipine (Plendil\u00ae)" - ], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n Volunteers who met the following criteria were included in the study \n\n Were in the age range of 18-45 years. \n\n Were neither overweight nor underweight for their height as per the Life Insurance Corporation of India height/weight chart for non-medical cases. \n\n Had voluntarily given written informed consent to participate in this study. \n\n Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study. \n\n Had a non-vegetarian diet habit. \n\n ", - "exclusion_criteria": ": \n\n History of known hypersensitivity to Felodipine, related drugs and or any other drug \n\n Individuals with systolic blood pressure <100 mmHg or >140mmHg diastolic blood pressure < 60 mmHg or >90 mmHg, at the time of admission in period I. \n\n History of chronic headache, dizziness and syncope. \n\n History of peripheral edema. \n\n History of grapefruit juice and / or grapefruit supplements intake in past 48 hours. \n\n Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations \n\n Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection. \n\n Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for hemoglobin, total white blood cells count, differential WBC count or platelet count. \n\n Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids). \n\n Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol. \n\n Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), glucose (positive) or protein (positive). \n\n Clinically abnormal ECG or Chest X-ray. \n\n History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma. \n\n History of any psychiatric illness which might impair the ability to provide written informed consent. \n\n Regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining from smoking for the duration of each study period. \n\n History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or had difficulty in abstaining for the duration of each study period. \n\n Use of any enzyme modifying drugs within 30 days prior to Day 1 of the study. \n\n Participation in any clinical trial within 12 weeks preceding Day 1 of the study. \n\n Subjects who, through completion of this study, would have donated and/or lost more than 350 mL of blood in the past 3 months.", - "brief_summary": "The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing felodipine extended release tablets USP 10 mg (containing felodipine 10 mg) manufactured by OHM Laboratories Inc., NJ, 08901 with PLENDIL\u00ae extended release tablets 10 mg (containing felodipine 10 mg) manufactured by Merck & Co. Inc. Whitehouse Station, NJ 08889 USA for AstraZeneca LP Wilmington, DE 19850 in healthy, adult, male, human subjects under fed condition.", - "NCTID": "NCT02311530" - }, - { - "brief_title": "Parenteral Phenoxybenzamine During Congenital Heart Disease Surgery", - "phase": "Phase 2", - "drugs": "['Phenoxybenzamine', 'Standard surgical approach']", - "drugs_list": [ - "Phenoxybenzamine", - "Standard surgical approach" - ], - "diseases": "['Congenital Heart Disease']", - "diseases_list": [ - "Congenital Heart Disease" - ], - "enrollment": "0.0", - "inclusion_criteria": "Patient selection will be determined by an assessment of the risk of systemic ventricular dysfunction following open cardiac repair in a population of infants undergoing stage I palliation (Norwood procedure) for the diagnosis of either hypoplastic left heart syndrome or similar left-sided obstructive lesions in the setting of single-ventricle physiology. Eligible neonates and infants include those aged 0 days to 6 months. These patients will be evaluated on an individual basis and the decision to give phenoxybenzamine would be determined by the attending surgeon, anesthesiologist, and cardiologist.", - "exclusion_criteria": "", - "brief_summary": "Phenoxybenzamine, an irreversible alpha-adrenergic blocker, may prove beneficial to infants and children with congenital heart disease undergoing open cardiac repair, due to a theoretic benefits of a uniform and smooth reduction in systemic vascular resistance in the perioperative period. Vasodilation allows for low pressure, high flow systemic perfusion while on cardiopulmonary bypass. Support for the use of phenoxybenzamine in humans has been documented in several studies involving the perioperative management of both adults and children requiring cardiopulmonary bypass, and in management of patients with pheochromocytoma. 1-7 Phenoxybenzamine has been associated with more uniform body cooling and rewarming, and improved tissue perfusion during bypass.8 It is also known to increase cardiac output, stroke volume, and renal blood flow when given intravenously. 9 Specifically in pediatric open heart surgery, the combined use of phenoxybenzamine and dopamine provided a stable hemodynamic condition without a high total peripheral vascular resistance and stimulated postoperative diuresis. 9 Afterload reduction with parenteral phenoxybenzamine in neonates undergoing the Norwood procedure for hypoplastic left heart syndrome is associated with improved systemic oxygen delivery and stabilization of systemic vascular resistance.10 Furthermore, a strategy of reducing afterload with phenoxybenzamine and stabilizing the pulmonary to systemic flow ratio in this select population of patients has also been shown to improve operative survival. 11 We hypothesize that phenoxybenzamine will reduce afterload on the systemic ventricle in our selected patient population, thereby improving ventricular performance and decreasing the risks of pulmonary to systemic flow imbalance associated with current short-acting vasodilator therapy. We will plan to evaluate both physiologic variables as well as surgical outcomes in the selected study population.", - "NCTID": "NCT00770705" - }, - { - "brief_title": "High-dose Ibuprofen for Patent Ductus Arteriosus (PDA) in Preterm Infant", - "phase": "Phase 2; Phase 3", - "drugs": "['Ibuprofen']", - "drugs_list": [ - "Ibuprofen" - ], - "diseases": "['Ductus Arteriosus, Patent']", - "diseases_list": [ - "Ductus Arteriosus", - "Patent" - ], - "enrollment": "70.0", - "inclusion_criteria": "inclusion criteria: Gestational age <29 weeks; an echocardiographic evidence of significant PDA; an age of 12 to 24 hours; and RDS necessitating respiratory support. \n\n - \n\n ", - "exclusion_criteria": ": Major congenital anomalies; life-threatening infection or hydrops fetalis; pulmonary hypertension; death before the conclusion of the first course of ibuprofen; urine output below 1 ml per kilogram of body weight per hour during the preceding 12 hours (with the exception of the first dose); a serum creatinine concentration of >1.5 mg/dL (129 \u03bcmol per liter); a platelet count of <50,000/mm3; a tendency to bleed, as revealed by hematuria, blood in the endotracheal aspirate, gastric aspirate, or stools, and oozing from puncture sites. \n\n -", - "brief_summary": "The investigators hypothesized that the early treatment of PDA with ibuprofen doses higher than those actually recommended might increase the closure rate in preterm infants with gestational age <29 weeks without increasing the occurrence of associated adverse effects. To assess this hypothesis the investigators planned a multicenter randomized controlled study to compare the effectiveness of the current ibuprofen regimen to that of a high-dose regimen in closing PDA.", - "NCTID": "NCT01243996" - }, - { - "brief_title": "Bosutinib For Autosomal Dominant Polycystic Kidney Disease", - "phase": "Phase 2", - "drugs": "['Bosutinib', 'Bosutinib', 'Placebo']", - "drugs_list": [ - "Bosutinib", - "Bosutinib", - "Placebo" - ], - "diseases": "['Polycystic Kidney, Autosomal Dominant']", - "diseases_list": [ - "Polycystic Kidney", - "Autosomal Dominant" - ], - "enrollment": "172.0", - "inclusion_criteria": "inclusion criteria: \n\n Males and females, 18 to 50 years old at the time of consent. \n\n Documented diagnosis of ADPKD (PKD-1 or PKD-2 genotypes allowed). \n\n Total kidney volume \u2265 750 cc, as measured by centrally evaluated MRI. \n\n ", - "exclusion_criteria": ": \n\n eGFR < 60 mL/min/1.73m2. \n\n Uncontrolled hypertension (defined as systolic blood pressure \u2265140 or diastolic blood pressure \u226590 mm Hg). \n\n Any previous exposure to the bosutinib test article or receipt of other polycystic kidney disease (PKD) therapies.", - "brief_summary": "This purpose of this study is to determine if bosutinib reduces the rate of kidney enlargement in subjects with autosomal dominant polycystic kidney disease (ADPKD) entering the study with a total kidney volume greater than or equal to 750 cc and eGFR greater than or equal to 60 mL/min/1.73m2.", - "NCTID": "NCT01233869" - }, - { - "brief_title": "Renal Effects of Levosimendan in Cardiac Surgery Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Treatment of Left Heart Insufficiency in an Operative Setting of Cardiac Surgery']", - "diseases_list": [ - "Treatment of Left Heart Insufficiency in an Operative Setting of Cardiac Surgery" - ], - "enrollment": "92.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients undergoing cardiac surgery (OPS 5-35 bis 5-37) between 2007 and 2011 followed by postoperative observation on an ICU of the anaesthesiology department of the Charit\u00e9 hospital \n\n ", - "exclusion_criteria": ": \n\n Patients younger 18 \n\n Preexisting renal insufficiency", - "brief_summary": "Recent experimental and clinical data suggest a benefit of levosimendan on the kidney function. Therefore, this retrospective, single center, matched-pairs analysis aimed to investigate whether administration of levosimendan was associated with improved renal function in cardiac surgery patients.", - "NCTID": "NCT01918618" - }, - { - "brief_title": "Evaluate the Nephrotoxicity by 6% Hydroxyethyl Starch 130/0.4 in Old Patients During Orthopaedic Surgery", - "phase": "", - "drugs": "['Hydroxyethyl Starch', 'Lactate Ringers']", - "drugs_list": [ - "Hydroxyethyl Starch", - "Lactate Ringers" - ], - "diseases": "['Total Fluid Volume Increased']", - "diseases_list": [ - "Total Fluid Volume Increased" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Old patients scheduled to undergo orthopaedic surgery under a intravertebral anesthesia. (American Society of Anesthesiologists physical status I-\u2162) \n\n ", - "exclusion_criteria": ": \n\n Allergy and contraindication to HES \n\n Infections and malignancies \n\n Sepsis \n\n History of heart failure or New York Heart Association(NYHA)>\u2162 \n\n Renal failure or Cr>108\u03bcmol/L\uff0cBUN>8.3mmol/L \n\n Undergoing dialytic treatments \n\n Intracranial hemorrhages \n\n Taking non-steroidal antiinflammatory agent for a long time \n\n Inability to understand the Study Information Sheet and provide a written consent to take part in the study", - "brief_summary": "Hydroxyethyl starch (HES) is commonly used as plasma expander during surgery but may be nephrotoxic as seen in studies in patients with sepsis. The investigators hypothesized that the possible nephrotoxicity of 6% HES 130/0.4 could be revealed by measurements of urinary and plasma neutrophil gelatinase-associated lipocalin and interleukin-18 (IL-18) in old patients with normal renal function during orthopaedic surgery.", - "NCTID": "NCT02361736" - }, - { - "brief_title": "Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers", - "phase": "", - "drugs": "['Intermittent catheter CP063CC', 'SpeediCath']", - "drugs_list": [ - "Intermittent catheter CP063CC", - "SpeediCath" - ], - "diseases": "['Spinal Cord Injury']", - "diseases_list": [ - "Spinal Cord Injury" - ], - "enrollment": "41.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years or older \n\n Male \n\n signed informed Consent, \n\n Neg. urine multistix \n\n ", - "exclusion_criteria": ": \n\n Abnormalities, \n\n diseases or surgical procedures performed in the lower urinary-tract", - "brief_summary": "The purpose of this study is to evaluate the safety of a new developed catheter in comparison with an catheter on the market. The study is randomised.", - "NCTID": "NCT01142115" - }, - { - "brief_title": "Therapeutic Effect of Tacrolimus in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic Syndrome", - "phase": "Phase 2; Phase 3", - "drugs": "['Tacrolimus']", - "drugs_list": [ - "Tacrolimus" - ], - "diseases": "['Minimal Change Disease']", - "diseases_list": [ - "Minimal Change Disease" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n from 18yrs to 80 yrs , man and women \n\n Minimal change disease is diagnosed by kidney biopsy \n\n On screening, the patient shows that the level of urine protein/creatinine ratio is over 3.0 \n\n On screening, the patient shows that the serum albumin is below 3.0g/dL \n\n the patient sign on the concent form \n\n ", - "exclusion_criteria": ": \n\n the patient have experience to take tacrolimus or cyclosporin for 1 month \n\n If it is the relapse of the nephrotic syndrome, before relapse, the maintenance dose of steroid is over 0.3 mg/kg/day \n\n steroid dependent or steroid resistant or frequent relapse case \n\n uncontrolled hypertension \n\n pregnancy or anticipate pregnancy with 6 month \n\n hypersensitivity to tacrolimus or macrolide \n\n acute hepatitis or the level of AST or ALT is over 2 times of normal range or the level of bilirubin is over 2.0 mg/dL", - "brief_summary": "The hypothesis of this study is that tacrolimus reduces the proteinuria in adult patient with minimal change nephritic syndrome.", - "NCTID": "NCT01084980" - }, - { - "brief_title": "Cyclophosphamide and Fludarabine to Treat Lupus Nephritis", - "phase": "Phase 1", - "drugs": "['SQ Fludarabine']", - "drugs_list": [ - "SQ Fludarabine" - ], - "diseases": "['Glomerulonephritis', 'Lupus Nephritis', 'Systemic Lupus Erythematosus']", - "diseases_list": [ - "Glomerulonephritis", - "Lupus Nephritis", - "Systemic Lupus Erythematosus" - ], - "enrollment": "15.0", - "inclusion_criteria": "Patients must be 18 years of age or older and able to provide informed consent. \n\n Patients must have at least 4 criteria for SLE as defined by the American Rheumatism Association (ARA). \n\n Active glomerulonephritis with: \n\n Renal biopsy within 1 year with class III or class IV active lupus nephritis, AND; \n\n Abnormal urine analysis: \n\n Greater than 10 RBC/hpf and cellular (RBC, WBC or mixed) casts, OR; \n\n Greater than 10 RBC/hpf and proteinuria greater than 2 g/day, OR; \n\n Proteinuria greater than 3.5 g/day. \n\n No patients with severe proliferative lupus nephritis: a. very active renal histology with crescents or necrosis in more than 25% of glomeruli; or b. rapidly progressive glomerulonephritis (doubling of serum creatinine in less than or equal to 3 months); or c. severe impairment of renal function Cr greater than 2.5 mg/dL or GFR less than 50 mL/min measured by inulin clearance. \n\n Patient has not had previous immunosuppressive therapy: \n\n Patients must not be receiving azathioprine, cyclosporine, methotrexate. Patients receiving these drugs will be eligible only if these drugs are discontinued and after a waiting period of greater than or equal to 4 weeks; \n\n Patients must not be receiving cyclophosphamide: \n\n Greater than 3 pulses (maximum 1 g/m(2)/pulse) within the last 12 months or since last renal biopsy showing active disease; OR \n\n greater than 6 pulses ever. \n\n Patients must not have had pulse therapy with glucocorticoids or any experimental therapy during the 4 weeks before study entry. \n\n Patients who need at study entry oral corticosteroids in dosages greater than 0.5 mg/kg/day of predisone to control extrarenal disease are not eligible. \n\n Patients with active or chronic infection are not eligible. \n\n Patients who are pregnant, breast-feeding or using inadequate birth control are not eligible. \n\n Patients who have poorly controlled diabetes mellitus or with evidence of end-organ damage are not eligible. \n\n No history of cerebrovascular accident, seizures within the last 5 years or chronic neurologic disease. \n\n No history of malignancy other than squamous cell and/or basal carcinoma of the skin. \n\n No confounding medical illness that in the judgment of investigators would pose added risk for study participants such as: \n\n Unstable coronary artery disease, cardiomyopathy or dysrhythmia requiring therapy; \n\n Pulmonary disease (PFTs less 70% of predicted value or DLCO less than 60%), or; \n\n Hematologic disease (Hb less than 8 mg/dL, platelets less than 100,000 micro liters or WBC less than 2,500/micro liters.", - "exclusion_criteria": "", - "brief_summary": "This study will test the safety and effectiveness of combination therapy with cyclophosphamide (Cytoxan) and fludarabine in treating lupus nephritis (kidney inflammation). This condition, common in patients with systemic lupus erythematosus, is caused by abnormal action of immune cells called lymphocytes against the kidneys. Left untreated, severe cases can result in loss of kidney function. The current treatment of choice-intermittent high doses (pulses) of cyclophosphamide-does not work in all patients and causes infertility in many women. The rate of infertility in men is not known. This study will examine whether fludarabine can safely be given with significantly lower doses of cyclophosphamide, and if this combination controls kidney inflammation.~Patients 18 years of age and older with severe lupus nephritis (called proliferative lupus nephritis) may be eligible for this study. Candidates will have a history and physical examination; blood and urine tests; chest X-ray; electrocardiogram; cancer screening that may include a Pap smear, mammogram, rectal examination, PSA testing, and sigmoidoscopy.~Participants will be divided into one of the following treatment groups:~Group 1-Patients undergo three treatment cycles of cyclophosphamide, taken by mouth, and fludarabine, injected subcutaneously (under the skin). Patients receive both drugs on day 1 of the cycle, and fludarabine alone on days 2 and 3. This regimen is repeated once every 5 weeks for three cycles.~Group 2-Same as for Group 1, except fludarabine injections are given intravenously (through a vein) for the second treatment cycle. Patients in this group have frequent blood sampling during the first and second treatment cycles to monitor blood levels of the drug. Samples are collected before the first injection is given and at 0.5, 1, 1.5, 2, 4, 8, 24 and 48 hours after the third injection. A total 12 tablespoons of blood is drawn over a 2-month period.~All patients will have blood drawn once or twice a week during the first two cycles and then less frequently to monitor blood counts. Some patients will have the following additional procedures to test the effects of treatment on lymphocytes:~Blood sample collection~Bone marrow aspiration-The skin over the hip bone is cleaned and a local anesthetic is injected into the outer covering of the bone. Bone marrow is suctioned through the needle into an attached syringe. The procedure is done before treatment begins, at the end of treatment, and 6 months after treatment.~Tonsillar biopsy-The tonsils are numbed with a local anesthetic and 1 to 4 pieces of tissue are removed using special forceps. The procedure is done before treatment begins, at the end of treatment, and 6 months after treatment.~Magnetic resonance imaging (MRI) of the abdomen-The patients lies on a table in a narrow cylinder (the MRI scanner) containing a strong magnetic field, which is used to create images of parts of the body in small section views.~Patients will be followed for at least 24 months to monitor late side effects and the response to treatment.", - "NCTID": "NCT00001676" - }, - { - "brief_title": "Cylexin for Reduction of Reperfusion Injury in Infant Heart Surgery", - "phase": "Phase 2; Phase 3", - "drugs": "['CY-1503']", - "drugs_list": [ - "CY-1503" - ], - "diseases": "['Congenital Heart Defects']", - "diseases_list": [ - "Congenital Heart Defects" - ], - "enrollment": "242.0", - "inclusion_criteria": "inclusion criteria:1) scheduled cardiac surgery with hypothermic CPB to repair either D-transposition of the great arteries (D-TGA) with intact ventricular septum (IVS) or ventricular septal defect (VSD), VSD with or without aortic arch obstruction (AAO), tetralogy of Fallot (TOF) with or without pulmonary atresia (PA), truncus arteriosus, total anomalous pulmonary venous return (TAPVR), or double outlet right ventricle (DORV), or to palliate hypoplastic left heart syndrome (HLHS) or other forms of single ventricle (SV) with AAO using the stage I (Norwood) operation, 2) age 1-45 days at surgery, 3) birth weight > 2.3 kg, and 4) a cranial ultrasound < 1 week prior to enrollment showing at most grade II hemorrhage in high risk patients - \n\n ", - "exclusion_criteria": ":", - "brief_summary": "We conducted a multicenter, randomized, placebo-controlled trial of Cylexin, an inhibitor of the attachment of white blood cells to the endothelium. Our study population was neonates and infants undergoing hypothermic cardiopulmonary bypass during surgical repair or palliation of congenital heart defects.", - "NCTID": "NCT00226369" - }, - { - "brief_title": "Efficacy of Dexmedetomidine for Postoperative Analgesia in Infantile Cataract Surgery", - "phase": "Phase 2; Phase 3", - "drugs": "['SB dexmedetomidine bupivacaine block', 'intravenous dexmedetomidine']", - "drugs_list": [ - "SB dexmedetomidine bupivacaine block", - "intravenous dexmedetomidine" - ], - "diseases": "['Postoperative Pain', 'Postoperative Vomiting']", - "diseases_list": [ - "Postoperative Pain", - "Postoperative Vomiting" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n ASA physical status grade I and II infants (1-12month). \n\n undergoing elective cataract surgery in one eye under general anesthesia. \n\n ", - "exclusion_criteria": ": \n\n infection of the orbit, \n\n increased intraocular pressure(IOP), \n\n history of allergy to local anesthetics, \n\n history of previous eye surgery, \n\n cardiovascular or clotting disorders, \n\n full stomach,inner ear disorders or other conditions predisposing to vomiting \n\n airway abnormalities \n\n compromised sclera.", - "brief_summary": "The purpose of the present study was to evaluate the efficacy and safety of subtenon block (SB)anesthesia with dexmedetomidine in combination with bupivacaine versus intravenous dexmedetomidine for postoperative analgesia and emesis control in infants undergoing cataract surgery.", - "NCTID": "NCT02495220" - }, - { - "brief_title": "Study of Triostat in Infants During Heart Surgery", - "phase": "Phase 3", - "drugs": "['Liothyronine sodium/triiodothyronine', 'Cardiopulmonary bypass and cardiac surgery']", - "drugs_list": [ - "Liothyronine sodium/triiodothyronine", - "Cardiopulmonary bypass and cardiac surgery" - ], - "diseases": "['Heart Defects, Congenital']", - "diseases_list": [ - "Heart Defects", - "Congenital" - ], - "enrollment": "195.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of one of the following: \n\n Ventricular septal defect (VSD) \n\n Infant coarctation of the aorta \n\n Transposition of the great arteries \n\n Tetralogy of Fallot \n\n Complete atrioventricular canal defect \n\n Hypoplastic left heart, including patients who undergo a Norwood type procedure for aortic or mitral atresia \n\n Patient must be scheduled for surgery. \n\n ", - "exclusion_criteria": ": \n\n Certain additional defects and/or requirement for additional surgery.", - "brief_summary": "This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery.", - "NCTID": "NCT00027417" - }, - { - "brief_title": "A Comparitive Bioavailability Study of Metformin Hydrochloride Liquid 500mg/ 5 mL Under Fasting Conditions and After Low and High Fat Meal", - "phase": "", - "drugs": "['Metformin solution 100 mg/mL']", - "drugs_list": [ - "Metformin solution 100 mg/mL" - ], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "34.0", - "inclusion_criteria": "inclusion criteria: \n\n Be in the age range of 18.45 years. \n\n Be neither overweight nor underweight for his/her height as per the Life Insurance Corporation of India height/weight chart for non-medical cases. \n\n Have voluntarily given written informed consent to participate in this study. \n\n Be of normal health as determined by medical history and physical \n\n Examination of the subjects performed .within 28 days prior to the commencement of the study. \n\n If female and: \n\n Of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or \n\n Is postmenopausal for at least 1 year; or Is surgically sterile bilateral tubal ligation, bilateral oophorectomy, or hysterectomy). \n\n ", - "exclusion_criteria": ": \n\n History of allergy to metformin and other related antidiabetic biguanide preparations. \n\n Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations. \n\n Presence of disease markers of HIV 1 and 2, Hepatitis B and C viruses and syphilis infection. \n\n Female volunteers demonstrating a positive pregnancy screen. \n\n Female volunteers who are currently breastfeeding. \n\n Presence of values' which are clinically significantly different from normal reference ranges for hemoglobin, total white blood cells count, differential WBC count and platelet count \n\n Positive for urinary screen testing of drugs of abuse (opiates and cannabinoids \n\n Presence of values which are significantly different from normal.reference ranges (as defined in Appendix 5) for se- rum creatinine, blood urea nitrogen serum aspartate aminotransferase (AST), serum alanine aminotranferase (ALT), serum alkaline phosphatase, serum billrubin, plasma glucose and serum cholesterol \n\n Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), epithelial cells (>4/HPF), glucose, (positive) and protein (positive). \n\n History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes or glaucoma. \n\n History of any psychiatric illness. which may impair the ability to provide written informed consent. \n\n Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period. \n\n History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 'unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or have difficulty in abstaining for the duration of each study period. \n\n Use of any enzyme modifying drugs within 30 days prior to Day I of this study", - "brief_summary": "To assess the food effect on pharmacokinetic profile of metformin liquid 100 mg/mL of Ranbaxy Laboratories in healthy, adult, human subjecis following a dose administration of 10 mL (1000 mg) under fasting conditions, after a Iow fat meal and after a high fat meal", - "NCTID": "NCT00778349" - }, - { - "brief_title": "Phase I Study Assessing the Ocular and Systemic Safety and Tolerability of OC-10X", - "phase": "Phase 1", - "drugs": "['OC-10X']", - "drugs_list": [ - "OC-10X" - ], - "diseases": "['Proliferative Diabetic Retinopathy (PDR)']", - "diseases_list": [ - "Proliferative Diabetic Retinopathy (PDR)" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria \n\n Ability to provide approved written informed consent and comply with study-related procedures/assessments for the duration of the study, age > 18 years \n\n Corrected visual acuity >20/25 in both eyes \n\n IOP <21 mm Hg, with a difference between eyes of < 4 mm Hg \n\n Ability to tolerate and self-administer vehicle eye drops. \n\n Tolerance of a commercially available non-preserved, artificial tear solution \n\n Normal slit lamp exam and dilated fundoscopic exam within one week previous to dosing \n\n Normal clinical laboratory profiles for complete blood count, serum chemistry and electrolytes, and urinalysis with no clinically significant values \n\n Be neither overweight nor underweight for his/her height as per BMI scale (18.5-24.9) \n\n Female of childbearing potential: \n\n Is practicing an acceptable method of birth control for the duration of the study, such as condoms, foams, jellies, diaphragm, IUD, or abstinence; or \n\n Is postmenopausal for at least 1 year; or \n\n Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) \n\n ", - "exclusion_criteria": " \n\n Evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations \n\n History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological, hematological disease, diabetes, glaucoma, head-injury or coma \n\n History of significant recurrent bacterial, viral or fungal infections \n\n History of any psychiatric illness, which may impair the ability to provide written informed consent \n\n Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection \n\n Presence of values which are significantly different from normal reference ranges and/or judged clinically significant for haemoglobin, total white blood cells count, differential white blood cell count or platelet count \n\n Positive urinary screen testing of drugs of abuse (opiates, cannabinoids, amphetamines, barbiturates, benzodiazepines, cocaine) \n\n Presence of values, which are significantly different from normal reference ranges and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase, serum alanine aminotransferase, serum alkaline phosphatase, serum bilirubin, plasma glucose, serum cholesterol, serum electrolytes (sodium, potassium, chloride, calcium and phosphorus),serum proteins (albumin and globulin) and serum creatinine phosphokinase \n\n Clinically abnormal chemical and microscopic examination of urine defined as presence of red blood cells, white blood cells (>4/High Power Field [HPF]), glucose (positive) or protein (positive) \n\n Clinically abnormal electrocardiogram \n\n Regular smokers, who smoke more than 10 cigarettes daily, or have difficulty abstaining from smoking \n\n History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or have difficulty in abstaining from drinking \n\n Subjects who, through completion of this study, would have donated and/or lost more than 400 mL of blood in past 2 months \n\n History of ocular surgery, trauma, or chronic ocular disease \n\n Current use of contact lenses or discontinuation of contact lens use within 2 weeks of the first dosing day \n\n Any ocular abnormalities or ocular symptoms \n\n Use of ocular agents (including eye drops) within the past 2 months or anticipated use of ocular agents during the study period \n\n Systemic corticosteroid use within the past 6 months \n\n History or evidence of ocular infection, inflammation, blepharitis, or conjunctivitis with 2 months; history of herpes simplex keratitis \n\n Presence of a non-healing wound, ulcer, fracture, or any medical condition associated with bleeding. \n\n Use of antimitotic or antimetabolite therapy within 2 months of enrollment. \n\n Women who are pregnant or breastfeeding, or nonsterile or premenopausal women who refuse to use any form of contraception during and for at least 2 weeks following the final dose of study drug. \n\n Enrollment in another investigational drug or device study within 2 months of study entry. \n\n Known intolerance or hypersensitivity to any components/excipients in the study drug formulation. \n\n Planned use during the study of any ocular or systemic medication, with the exception of oral contraceptives and short-term use of over-the-counter analgesics.", - "brief_summary": "The present study is intended to evaluate the safety and tolerability of topical OC-10X Ophthalmic Suspension in healthy human subjects. OcuCure Therapeutics, Inc. (Roanoke, VA) has developed a lead compound, known as OC-10X, which is a selective tubulin inhibitor under development for the treatment of Proliferative Diabetic Retinopathy (PDR) and Age-related Macular Degeneration (AMD). When administered as a topical eye drop, OC-10X has demonstrated both anti-angiogenic (inhibition) and angiolytic (regression) properties in animal models of AMD. Unlike other therapies, OC-10X provides the efficacy of a vascular targeting agent without the traditional toxicity and works downstream independently of growth factors. As demonstrated by OcuCure's preclinical data, tubulin inhibition using OC-10X has promise as a new therapeutic approach. PDR is a major cause of blindness in adults and is also caused by the growth of abnormal blood vessels. These new blood vessels are fragile and may hemorrhage into the vitreous. PDR affects up to 80% of all diabetics who have had diabetes for 15 years or more. If administration of OC-10X is well tolerated as a topical eye drop and is well tolerated systemically, then OC-10X will have the potential to provide benefits to patients with ocular diseases associated with angiogenesis.", - "NCTID": "NCT01869933" - }, - { - "brief_title": "Enteroaggregative E.Coli (EAEC)", - "phase": "Phase 1", - "drugs": "['Levofloxacin', 'Placebo', 'Enteroaggregative E. coli (EAEC)']", - "drugs_list": [ - "Levofloxacin", - "Placebo", - "Enteroaggregative E. coli (EAEC)" - ], - "diseases": "['Escherichia Coli Infections']", - "diseases_list": [ - "Escherichia Coli Infections" - ], - "enrollment": "5.0", - "inclusion_criteria": "inclusion criteria: \n\n Sign an Institutional Review Board-approved consent prior to any study-related activities. \n\n Initiate screening 21\u00b1 7 days prior to admission or enrollment. \n\n Must accomplish all laboratory and diagnostic examinations at 21\u00b1 7 days prior to admission or enrollment. \n\n Be at least 18 years of age but not older than 40 years of age at the time of enrollment. \n\n Be otherwise healthy with a stable address and telephone where the volunteer can be contacted. \n\n Be able to read and write English. \n\n Possess a social security number in order to receive compensation. \n\n Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the morning of the challenge and use effective birth control during the entire study period. Methods of effective birth control include: complete abstinence, the use of a licensed hormonal method, intrauterine device, barrier method plus spermicide, or having sexual relations exclusively with a vasectomized partner. Appropriate barrier methods include condoms, cervical sponge, and diaphragm. Females who are not of childbearing potential are defined as those who are physiologically incapable of becoming pregnant, including any female with tubal ligation or who is postmenopausal. For purposes of this study, postmenopausal status will be defined as absence of menses for at least 1 year. \n\n Be seronegative for antibodies to dispersin. \n\n Have normal laboratory screening values including a white blood cell (WBC) count, hemoglobin, hematocrit, platelets, blood urea nitrogen, glucose, creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), quantitative immunoglobulins, T cell subsets (CD4 and CD8), urinalysis. \n\n Have normal chest x-ray and electrocardiogram. \n\n Have negative serologies for HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV), and a negative rapid plasma reagin (RPR). \n\n Have a negative stool examination for pathogenic ova and pathogenic parasites, and bacterial enteropathogens (EAEC, Salmonella, Shigella, Campylobacter). \n\n Have the -251 AA IL-8 genotype. \n\n ", - "exclusion_criteria": ": \n\n Has acute or chronic medical illness (i.e., renal or hepatic disease, hypertension, diabetes mellitus, coronary artery disease, malnutrition, obesity (body mass index >30 kg/m2), HIV, corticosteroid use, cancer or receiving chemotherapy, chronic debilitating illness, syphilis). \n\n Has used antibiotics within 7 days of challenge. \n\n Has used medications or drugs, including over-the-counter medications such as decongestants, antacids (calcium carbonate or aluminum-based antacids, H2 blockers), anti-diarrheal medications (such as bismuth subsalicylate or loperamide), antihistamines within 7 days of challenge. \n\n Has a history of chronic gastrointestinal illness, intra-abdominal surgery, chronic functional dyspepsia, chronic gastroesophageal reflux, documented peptic ulcer disease, gastrointestinal hemorrhage, gallbladder disease, inflammatory bowel disease (Crohn's and ulcerative colitis), diverticulitis, irritable bowel syndrome or frequent diarrhea. \n\n Has a history any of the following psychiatric illness(es): \n\n Depression not controlled with current drug therapy or involving institutionalization \n\n Schizophrenia or psychosis \n\n Suicide attempt. \n\n Has a history of or current alcohol or illicit drug abuse. \n\n Is unable to remain as an inpatient in the University Clinical Research Unit for up to 8 days. \n\n Has a known hypersensitivity to latex, heparin, opiates, antiemetics, benzodiazepines, lidocaine, magnesium citrate, or Fleet enema. \n\n Has a known hypersensitivity to antibiotics that could be used to treat EAEC infection including fluoroquinolones, amoxicillin, cephalosporins or rifaximin. \n\n Has serum antibodies to EAEC dispersin. \n\n Recently traveled to a developing country (within 6 months). \n\n Has household contacts who are less than 4 years of age or more than 80 years of age. \n\n Has household contacts that are infirmed or immunocompromised due to any of the following reasons: \n\n Corticosteroid therapy \n\n HIV infection \n\n Cancer chemotherapy \n\n Other chronic debilitating diseases. \n\n Works as health care personnel with direct patient care. \n\n Works in a day care center for children or the elderly. \n\n Is a food handler. \n\n Has factors that, in the opinion of the investigator or research personnel, would interfere with the study objectives or increase the risk to the volunteer or his contacts. \n\n Is currently participating in a clinical study or had receipt of an investigational drug in the past 30 days. \n\n Is pregnant or has a risk of pregnancy or is lactating. \n\n Has current excessive use of alcohol or drug dependence. \n\n Has evidence of impaired immune function. \n\n Has a new positive reaction to purified protein derivative (PPD) (volunteers who are known to be PPD positive that have a negative chest x-ray and have received isoniazid prophylaxis will be eligible). \n\n Has a stool culture that demonstrates the presence of pathogenic ova, pathogenic parasites, or bacterial enteropathogens (EAEC, Salmonella, Shigella, and Campylobacter), or that is devoid of normal flora. \n\n Has self-reported lactose or soy intolerance or allergy \n\n Is a smoker and cannot stop smoking for the duration of the inpatient study. \n\n Has abnormal lab results for screening beyond the normal range as defined below: \n\n Hematology Hemoglobin: 13-15.0 gm/dL (Females) 14.5-17.0 gm/dL (Males) Hematocrit: 37-46 % (Females) 40-52 % (Males) Platelet count: 140,000-415,000 per mm3 WBC count: 4,000-10,500 per mm3 Neutrophils: 40-74 % or 1,800-7,800 per mm3 Lymphocytes: 14-26 % or 700-4,500 per mm3 Monocytes: 4-13 % or 100-1,000 per mm3 Eosinophils: 0-7 % or 0-400 per mm3 Basophils: 0-3 % or 0-200 per mm3 \n\n Chemistry BUN 5-25 mg/dL Creatinine 0.5-1.4 mg/dL Glucose (fasting) 69-99 mg/dL ALT 0-40 U/L AST 0-40 U/L \n\n Immunology IgG: 596-1584 mg/dL IgA: 71-350 mg/dL IgM: 35-213 mg/dL CD4 T cells: 660-1500 cells/mcl CD8 T cells: 360-850 cells/mcl \n\n Urinalysis Urine color: Yellow Turbidity: Clear pH: 5.0-8.0 Protein: Negative Sp. Gravity: 1.003-1.030 Glucose: Negative WBC: 0-2 Cells per HPF RBC: 0 Cells per HPF Bacteria: Rare Ketones: Negative The urinalysis will initially be evaluated for the quality of collection. If urinalysis is found to be poorly collected and demonstrates the presence of squamous epithelial cells and bacteria, results will not be used and a repeat urinalysis will be requested. In the case of menstruating women, the urinalysis collection will be postponed temporarily. A urinalysis may also be repeated once if traces of bile, protein, trace ketones, or Hb are identified. In the case of a properly collected urinalysis, the presence of leukocyte esterase glucose, or nitrates will exclude the participation of the subject. \n\n Occult blood (Hemoccult) positive stools on admission to the CRU. \n\n Develops gastrointestinal symptoms including nausea, vomiting, anorexia, abdominal pain, cramping, bloating, excessive gas or flatulence, diarrhea, constipation, urgency or tenesmus between the screening period and prior to challenge. \n\n Develops a febrile illness during the period of time screening period and prior to challenge.", - "brief_summary": "Enteroaggregative E. coli (EAEC) is a bacterium that can cause diarrhea. The purposes of this study are to: determine how much EAEC is needed to cause diarrhea in a healthy person, determine if a genetic factor is important in causing diarrhea, and to see how the body's defenses control EAEC. Participants include 25 healthy adults, ages 18-40. Volunteers will be assigned to 1 of 4 dose levels in groups of 5 volunteers each. One volunteer in each group will receive a sodium bicarbonate placebo solution. Volunteers will be admitted to the University Clinical Research Unit for up to 8 days. Volunteers will receive therapy with levofloxacin to treat the infection either once they develop diarrhea or at Day 5 if they remain asymptomatic. Study procedures will include saliva, blood, and fecal sample collection. An optional study procedure will include an intestinal biopsy. Participants will be involved in study related procedures for up to 223 days.", - "NCTID": "NCT00362869" - }, - { - "brief_title": "Evaluating the Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis", - "phase": "Phase 2", - "drugs": "['Primary placement of a spring-loaded silo', 'Primary Closure']", - "drugs_list": [ - "Primary placement of a spring-loaded silo", - "Primary Closure" - ], - "diseases": "['Gastroschisis']", - "diseases_list": [ - "Gastroschisis" - ], - "enrollment": "88.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of Gastroschisis \n\n Birth Weight \u2265 1500 grams \n\n Gestational Age \u2265 34 weeks \n\n ", - "exclusion_criteria": ": \n\n Birth Weight < 1500 grams \n\n Gestational Age < 34 weeks \n\n Presence of Bowel Ischemia or Necrosis \n\n Abdominal wall defect too small \n\n Major associated anomalies or medical condition \n\n Presence of Intracranial Hemorrhage (grade IV) \n\n Parent Refusal for Randomization", - "brief_summary": "This study seeks to evaluate whether the routine, primary use of the spring-loaded silo (SLS) to treat infants with gastroschisis will result in improved outcomes, faster recovery times and fewer post-surgical complications than the standard selective use of the silo.", - "NCTID": "NCT00539292" - }, - { - "brief_title": "Zinc and Copper Absorption in Neonates With Bilious Losses", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Ileostomy']", - "diseases_list": [ - "Ileostomy" - ], - "enrollment": "17.0", - "inclusion_criteria": "inclusion criteria: \n\n Presence of ileostomy due to any disease or condition (i.e., necrotizing enterocolitis, intestinal atresias, gastroschisis, or intestinal perforations) \n\n Minimum birth weight of 500g \n\n Likely to survive \n\n ", - "exclusion_criteria": ": \n\n Dysmotility of the gastrointestinal system \n\n Major congenital anomalies, including heart disease \n\n Meconium ileus \n\n Not expected to survive for at least 2 weeks", - "brief_summary": "We propose to examine the absorption and excretion of zinc and copper in infants with ostomies. This will be accomplished by measuring baseline excretion and serum levels of zinc, copper, and ceruloplasmin, and by utilizing stable isotopes of zinc and copper to measure absorption and excretion.~To determine how the presence of an ileostomy impacts zinc and copper metabolism in infants at three time points: 1) when the infant has an ostomy and is receiving the majority of calories from total parenteral nutrition (TPN); 2) when the infant has an ostomy and is receiving primarily enteral nutrition without TPN; and 3) when/if the infant has a surgery to reconnect the bowel and is receiving primarily enteral nutrition.~For the first part of the study, excretion data for zinc will be obtained for ostomy patients. We hypothesize that infants with an ostomy will excrete more zinc in their stools than healthy term or preterm infants without ostomies.~For the second part of the study, we will obtain data on zinc absorption, secretion, and excretion through use of stable isotopes. Jalla et al determined that healthy infants retain zinc of 0.4 mg/day. We hypothesize that due to increased zinc losses, the infants in the study will be less positive than the healthy infants in the study by Jalla et al. Our study is designed to be able to detect if the ostomy patients net retention is one-half that described by Jalla (i.e. 0.2 mg/d). We will also obtain data on copper absorption, secretion, and excretion through the use of stable isotopes in the second part of the study. As a pilot study, we do not fully know what to expect regarding copper levels in infants with ostomies, but we hypothesize that they may be less positive than healthy infants without ostomies. Also, we hypothesize that zinc and copper are competitively absorbed in the gut; therefore, infants who receive more zinc may absorb less copper.~For the third part of the study, we will obtain data on zinc absorption through the use of stable isotopes after the infant has had surgery to reanastomose the bowel. We hypothesize that there may be continued zinc losses above those documented for healthy infants who have never had an ostomy, but decreased losses compared to when the infant had an ostomy.", - "NCTID": "NCT00738283" - }, - { - "brief_title": "Does Massage With or Without Aromatherapy Reduce Infant's Distress?", - "phase": "Phase 4", - "drugs": "['aromatherapy massage']", - "drugs_list": [ - "aromatherapy massage" - ], - "diseases": "['Distress']", - "diseases_list": [ - "Distress" - ], - "enrollment": "110.0", - "inclusion_criteria": "inclusion criteria: \n\n Infants aged 6 to 36 months admitted to the Intensive Care-Sophia after craniofacial surgery \n\n ", - "exclusion_criteria": ": \n\n Neurological impairment \n\n Eczema or other skin disorders \n\n Nut allergy", - "brief_summary": "This study aims to determine the effect of massage with or without aromatherapy on infant\u00b4s level of distress", - "NCTID": "NCT00624637" - }, - { - "brief_title": "A Trial to Assess Optimal Postoperative Feeding Regiments Following Pyloromyotomy", - "phase": "", - "drugs": "['Incremental Feeds', 'Ad lib feeds']", - "drugs_list": [ - "Incremental Feeds", - "Ad lib feeds" - ], - "diseases": "['Postoperative Feeding Following Pyloromyotomy']", - "diseases_list": [ - "Postoperative Feeding Following Pyloromyotomy" - ], - "enrollment": "163.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects to be included in the study include infants who have a diagnosis of pyloric stenosis who will undergo pyloromyotomy. \n\n ", - "exclusion_criteria": ": \n\n Patients with severe underlying medical conditions including but not limited to hypothermia, sepsis, glycemic instability, or need for care in the intensive care unit/neonatal intensive care unit will not be included in the study.", - "brief_summary": "There are several choices to consider when determining the timing of initiation of enteral feeds following a pyloromyotomy. Some practice patterns have initiated feedings as soon as the infant awakens from anesthesia. Some authors have suggested a period of withholding feedings for several hours postoperatively, while others have recommended a significantly longer period of starvation (18 hours) before initiating feedings. The ongoing debate arises over whether a physician chooses a standardized, incremental feeding regimen versus an ad libitum feeding schedule which allows the infant to decide when and how much to eat. Neither has been studied effectively in a randomized controlled setting. A recent review of the literature would suggest that a period of 4 hours of NPO, followed by ad lib feedings may be the best postoperative regimen. This however, has not been studied in a randomized, controlled trial.", - "NCTID": "NCT02415049" - }, - { - "brief_title": "Belatacept in Liver Transplant Recipients", - "phase": "Phase 2", - "drugs": "['Tacrolimus', 'Basiliximab', 'Belatacept More Intensive (MI)', 'Belatacept Less Intensive (LI)', 'Mycophenolate Mofetil (MMF)']", - "drugs_list": [ - "Tacrolimus", - "Basiliximab", - "Belatacept More Intensive (MI)", - "Belatacept Less Intensive (LI)", - "Mycophenolate Mofetil (MMF)" - ], - "diseases": "['Immunosuppression in Solid Organ Transplant']", - "diseases_list": [ - "Immunosuppression in Solid Organ Transplant" - ], - "enrollment": "260.0", - "inclusion_criteria": "inclusion criteria: \n\n First time recipient of deceased donor liver transplant \n\n Age 18-70 \n\n Hepatitis C virus (HCV) positive recipients \n\n For Long-term extension study-Subjects who have completed one year of study treatment (through Week 52) \n\n Target Disease Exclusions: \n\n Donor Exclusions a) Living donors b) ABO-incompatible donor recipient pairs c) Donor age < 12 or > 65 years d) Non heart-beating donors e) Anticipated cold ischemia time > 14 hours f) Donor Disease i) Known Human immunodeficiency virus (HIV) infection ii) Hepatitis B virus (HBV) surface antigen-positive or polymerase chain reaction (PCR)-positive donor if HBV negative recipient iii) HCV antibody-positive or PCR positive donor if HCV negative recipient \n\n Recipient Exclusions g) Subjects with a history of hypercoagulable state h) Subjects with fulminant hepatic failure i) Subjects receiving a split or reduced liver j) Subjects who are Epstein-Barr virus (EBV) negative \n\n Medical History and Concurrent Diseases \n\n Subjects who have received 2 or more consecutive weeks of dialysis 1 month prior to enrollment OR anticipated to have prolonged dialysis post-transplantation \n\n Subjects with known intrinsic renal disease (e.g., a urine protein/ creatinine ratio > 150 mg/g or the presence of an abnormal number of red blood cells (RBCs) or granular casts in the urine) AND calculated GFR < 40 ml/min/1.73 m^2 body surface area (BSA) (abbreviated Modification of Diet in Renal Disease [MDRD]). Subjects must have a calculated GFR assessment within 1 month prior to enrollment. \n\n Subjects with known HIV \n\n Subjects with any prior or concurrent solid organ (e.g., heart, kidney, pancreas) or cell (e.g., islet, bone marrow) transplant or subjects deemed likely to have a second solid organ or cell transplant (e.g., islet, bone marrow) within the next 3 years. \n\n Subjects with a history of cancer within the last 5 years \n\n Allergies and Adverse Drug Reactions \n\n a) Hypersensitivity to any medications that will be used in the protocol \n\n Prohibited Treatments and/or Therapies \n\n Subjects receiving immunosuppressive agent(s) (e.g., methotrexate, abatacept, infliximab, etanercept, chemotherapy, etc.) within the past 6 months for other indications such as an autoimmune disease \n\n Subjects who received maintenance corticosteroids at a dose of > 5 mg/day of prednisone (or equivalent) for at least 7 consecutive days within the prior year for an underlying chronic inflammatory or autoimmune disease \n\n Subjects who have used any investigational drug within 30 days prior to the Day 1 visit \n\n Subjects previously treated with belatacept", - "exclusion_criteria": "", - "brief_summary": "The purpose of this clinical research study is to evaluate the effects of belatacept, relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects receiving a liver transplant", - "NCTID": "NCT00555321" - } - ], - "1": [ - { - "brief_title": "Acute Kidney Injury in Neonates", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Acute Kidney Injury']", - "diseases_list": [ - "Acute Kidney Injury" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Families of infants (birthweight >1500g) be asked to participate in the study. \n\n ", - "exclusion_criteria": ": \n\n Infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded", - "brief_summary": "Our first aim is to describe how common a sudden decrease in renal function happens in infants in a neonatal intensive care unit. We also want to see how a sudden loss of renal function affects survival. Finally, we will explore non-invasive markers to identify a sudden decrease in renal function from urinary samples.", - "NCTID": "NCT00572715" - }, - { - "brief_title": "Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury", - "phase": "", - "drugs": "['acute extra renal replacement therapy']", - "drugs_list": [ - "acute extra renal replacement therapy" - ], - "diseases": "['Kidney Failure, Acute']", - "diseases_list": [ - "Kidney Failure", - "Acute" - ], - "enrollment": "310.0", - "inclusion_criteria": "inclusion criteria: \n\n Age < 18 years, including the newborn ; \n\n Acute kidney injury as defined by pRIFLE classification requiring extra renal replacement therapy, whatever is the method. \n\n ", - "exclusion_criteria": ": \n\n Treatment by extra renal replacement therapy for terminal renal failure; \n\n History of renal transplantation; \n\n Extra renal replacement therapy for an inborn errors of metabolism without acute renal failure; \n\n Extra renal replacement therapy in the context of a drug intoxication without acute renal failure; \n\n Treatment by technique in MARS (Molecular Adsorbent Recirculating System); \n\n Modified ultrafiltration during surgery.", - "brief_summary": "Limited prospective data is available to compare morbidity and mortality between renal replacement modalities in pediatric acute renal failure.~In the absence of clear standard of care, the choice of the extra renal replacement therapy modality is subject to clinical judgement, practical aspects, and costs.~This study will supply important data about usual modalities of pediatric acute extra renal replacement therapy and their impact on patient outcome and renal recovery. An obvious next step will be to conduct a randomized controlled trial comparing the different strategies.", - "NCTID": "NCT01569698" - }, - { - "brief_title": "Examining New Diagnostic Tests for Acute Kidney Injury After Heart Surgery", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Kidney Failure, Acute', 'Renal Insufficiency']", - "diseases_list": [ - "Kidney Failure", - "Acute", - "Renal Insufficiency" - ], - "enrollment": "1550.0", - "inclusion_criteria": "inclusion criteria for Adults: (must have at least one of the following) \n\n Emergent surgery \n\n Pre-existing kidney impairment (baseline serum creatinine greater than 2 mg/dL) \n\n Ejection fraction less than 35% \n\n At least 70 years old \n\n Diabetes mellitus \n\n Combined CABG and valve surgery \n\n Repeat CABG or valve surgery \n\n ", - "exclusion_criteria": " for Adults: \n\n Pre-operative acute kidney injury \n\n Enrolled in a conflicting research study \n\n Prior kidney transplantation \n\n Baseline serum creatinine level greater than 4.5 mg/dL \n\n Nephrotoxic drugs administered pre-operatively \n\n Surgery for only left ventricular assist device \n\n inclusion criteria for Children: \n\n Undergoing open heart surgery \n\n ", - "brief_summary": "People who undergo coronary artery bypass grafting (CABG) or heart valve surgery may experience acute kidney injury (AKI) after their surgery. Current medical tests cannot identify AKI until approximately 48 hours after it occurs. This study will examine three new biomarkers in blood and urine that may provide a more effective and faster way of predicting AKI in people who undergo CABG or heart valve surgery.", - "NCTID": "NCT00774137" - }, - { - "brief_title": "Forced Diuresis Versus Observation in Resolving Renal Failure After Haemofiltration in Critically Ill Patients", - "phase": "Phase 3", - "drugs": "['Furosemide']", - "drugs_list": [ - "Furosemide" - ], - "diseases": "['Renal Failure', 'Critically Ill']", - "diseases_list": [ - "Renal Failure", - "Critically Ill" - ], - "enrollment": "72.0", - "inclusion_criteria": "inclusion criteria: \n\n cessation of hemofiltration \n\n mechanical ventilation \n\n written informed consent \n\n ", - "exclusion_criteria": ": \n\n pre-existent renal failure \n\n glomerulonephritis", - "brief_summary": "Intensive care patients with multiple organ dysfunction syndrome often show renal failure with the need for hemofiltration. Resolving renal failure after cessation of hemofiltration may or may not be accompanied by oliguria. Whether or not the administration of diuretics at that moment is appropriate is not known. The study randomises between furosemide or placebo when hemofiltration is stopped. Study endpoint is recovery of renal function.", - "NCTID": "NCT00298454" - }, - { - "brief_title": "NGAL, an Early Predictive Marker of Acute Kidney Injury After Cardiac Surgery in Neonates and Infants", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Peritoneal Lesion']", - "diseases_list": [ - "Peritoneal Lesion" - ], - "enrollment": "205.0", - "inclusion_criteria": "inclusion criteria : \n\n term neonates and infants undergoing heart surgery with cardiopulmonary bypass \n\n parents received written information \n\n ", - "exclusion_criteria": " : \n\n preoperative documented kidney injury \n\n parents not informed, opposed", - "brief_summary": "Urinary NGAL has been shown to be an early marker of acute kidney injury (AKI) following paediatric cardiac surgery (2 hours off pump). Previous studies showed that an early increase of urinary NGAL following cardiopulmonary bypass was predictive of AKI. Several studies included heterogeneous populations of children undergoing cardiac surgery, but NGAL has not been studied in neonates after open heart surgery, neither has been identified the threshold for accurate prediction of severe AKI requiring renal replacement therapy.~The aim of this observational cohort study is to describe postoperative kinetics of urinary NGAL in neonates and to identify the threshold for accurate prediction of severe AKI requiring renal replacement therapy in neonates and infants undergoing cardiac surgery", - "NCTID": "NCT01219998" - }, - { - "brief_title": "The Effect of the Hydroxyethyl Starch on Kidney Injury in Pediatric Cardiac Surgery", - "phase": "", - "drugs": "['Crystalloid', 'Colloid']", - "drugs_list": [ - "Crystalloid", - "Colloid" - ], - "diseases": "['Acute Kidney Injury']", - "diseases_list": [ - "Acute Kidney Injury" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Children aged less than 7 years old \n\n American Society of Anesthesiology (ASA) physical status 1-3 \n\n ", - "exclusion_criteria": ": \n\n Preoperative creatinine > 1.5mg/dl \n\n History of dialysis \n\n Liver function abnormality \n\n Diabetes Mellitus \n\n History of allergic reaction \n\n Coagulation abnormality", - "brief_summary": "The investigator will evaluate the influence of colloid administration on postoperative acute kidney injury in pediatric patients undergoing cardiac surgery under cardiopulmonary bypass.", - "NCTID": "NCT02599155" - }, - { - "brief_title": "The Influence of Remote Ischemic Preconditioning on Acute Kidney Injury After Cardiac Surgery", - "phase": "Phase 1", - "drugs": "['Remote Ischemic Preconditioning']", - "drugs_list": [ - "Remote Ischemic Preconditioning" - ], - "diseases": "['Acute Kidney Insufficiency', 'Acute Renal Insufficiency', 'Acute Kidney Injury', 'Ischemic Preconditioning']", - "diseases_list": [ - "Acute Kidney Insufficiency", - "Acute Renal Insufficiency", - "Acute Kidney Injury", - "Ischemic Preconditioning" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient undergoing heart surgery on cardiopulmonary bypass. \n\n ", - "exclusion_criteria": ": \n\n Known peripheral vascular disease of the lower extremities associated with active skin necrosis or infection. \n\n End-stage renal disease. \n\n Inability to give informed consent.", - "brief_summary": "Acute kidney injury is associated with cardiopulmonary bypass during heart surgery and its pathogenesis is similar to that of ischemia-reperfusion injury. Remote ischemic preconditioning attenuates myocardial ischemia-reperfusion injury in patients undergoing coronary bypass surgery. The investigators hypothesize that such preconditioning reduces the incidence of acute kidney injury associated with cardiopulmonary bypass.", - "NCTID": "NCT00821522" - }, - { - "brief_title": "Study of Morphine in Postoperative Infants to Allow Normal Ventilation", - "phase": "", - "drugs": "['morphine']", - "drugs_list": [ - "morphine" - ], - "diseases": "['Infant, Newborn, Diseases', 'Pain']", - "diseases_list": [ - "Infant", - "Newborn", - "Diseases", - "Pain" - ], - "enrollment": "100.0", - "inclusion_criteria": "PROTOCOL ENTRY CRITERIA: \n\n --Disease Characteristics-- \n\n Infants scheduled for surgery with postoperative inpatient care \n\n Must be born after 35 weeks or more gestational age \n\n No prenatal opiate exposure \n\n Part I patients: \n\n Less than 12 months of age undergoing surgeries involving major thoracic, abdominal, or cardiac procedures \n\n No pneumonectomy, tracheal or bronchial stenosis reconstruction, diaphragmatic hernia repair, or surgeries resulting in high intraabdominal pressure (closure of large gastroschisis or omphalocele defects) \n\n No hepatic or renal transplantation \n\n Part II patients: \n\n Less than 3 months of age undergoing surgeries using a thoracotomy approach \n\n Cyanotic congenital heart disease having palliative systemic to pulmonary artery shunts created OR Thoracotomy for repair of acyanotic lesions (e.g., repairs of coarctation of the aorta, tracheoesophageal fistula repair, PDA ligation) \n\n --Patient Characteristics-- \n\n Age: Part I: Less than 12 months Part II: Less than 3 months \n\n Hepatic: Normal hepatic function tests \n\n Renal: Normal renal function tests \n\n Pulmonary: No pulmonary disease causing baseline hypercarbia \n\n No pulmonary hypertension contraindicating use of 5% CO2 in rebreathing studies \n\n Other: \n\n No allergy to morphine \n\n No severe developmental delay that precludes analgesia scoring", - "exclusion_criteria": "", - "brief_summary": "OBJECTIVES: I. Compare nonmechanically ventilated infants who receive morphine postoperatively as intermittent intravenous bolus doses or as a continuous intravenous infusion targeted to reach a steady-state concentration.~II. Assess ventilation (blood gases, continuous oximetry, and CO2 response curves) and analgesia (infant pain score) between the two treatment groups of infants.~III. Compare ventilation parameters (blood gases, CO2 response curves, and time to wean from assisted mechanical ventilation) in cyanotic and acyanotic infants after thoracotomies.", - "NCTID": "NCT00004696" - }, - { - "brief_title": "Prophylactic Use of Levosimendan Versus Milrinone in Open Heart Surgery in Infants", - "phase": "Phase 2", - "drugs": "['Levosimendan', 'Milrinone']", - "drugs_list": [ - "Levosimendan", - "Milrinone" - ], - "diseases": "['Low Cardiac Output Syndrome']", - "diseases_list": [ - "Low Cardiac Output Syndrome" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Age younger than one year \n\n corrective open heart surgery with biventricular repair, except tetralogy of fallot \n\n ", - "exclusion_criteria": ": \n\n Missing written consent of parents \n\n Weight less than 3 kg \n\n preoperative LCOS \n\n gestational age less than 36 weeks \n\n preexisting renal failure \n\n preexisting thrombopenia \n\n preoperative cardiopulmonary resuscitation \n\n preoperative use of milrinone or levosimendan", - "brief_summary": "Pediatric patients, especially infants undergoing open heart surgery have a predictable fall in cardiac index 6 to 18 hours after surgery, the so-called low cardiac output syndrome (LCOS). Patients, who have LCOS require more monitoring, more medication and a longer stay in intensive care unit. To prevent LCOS the phosphodiesterase inhibitor milrinone is routinely used during the first 24 hours after surgery. Levosimendan, a calcium- sensitizer improves cardiac muscle contractile force, vascular smooth muscle relaxation and coronary blood flow through calcium sensitization of the myocardial contractile filaments and opening of potassium channels without increasing oxygen consumption of the heart muscle cells. As the myocardium of infants is more calcium dependent than in later life, levosimendan should be of special benefit in this age group. The purpose of this study is to investigate whether levosimendan is superior to milrinone in preventing LCOS in infants after corrective open heart surgery.", - "NCTID": "NCT00549107" - }, - { - "brief_title": "Relationship of Gestational Age and Urine Concentration of S100B in Preterm and Term Infants in the First Week of Life", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Preterm and Term Infants']", - "diseases_list": [ - "Preterm and Term Infants" - ], - "enrollment": "106.0", - "inclusion_criteria": "inclusion criteria: \n\n Infants born at >28 weeks gestation will be eligible for enrollment in this study. \n\n ", - "exclusion_criteria": ": \n\n Infants with fetal malformations, chromosomal anomalies, clinically significant sepsis (retractable hypotension, neutropenia, and thrombocytopenia), or no urine output for the first 48 hours will be excluded.", - "brief_summary": "S100B, a calcium-binding protein, is found predominantly in the central nervous system (CNS) and is increased in CSF and blood after CNS injury. There are two objectives to this study. 1) To complement our previous study, is urine S100B concentration correlated with gestational age in infants born at > 28 weeks gestation during the first week of life? 2) Is the urine concentration of S100B affected by intracranial pathology in this gestational age range? Elevation of urine concentration of S100B may be an indicator that the infant will develop serious intracranial pathology and may allow for early initiation of treatment to potentially decrease morbidity.", - "NCTID": "NCT00747864" - }, - { - "brief_title": "Relative Adrenal Insufficiency in Preterm Very Low Birth Weight Infants With Shock", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Adrenal Insufficiency']", - "diseases_list": [ - "Adrenal Insufficiency" - ], - "enrollment": "39.0", - "inclusion_criteria": "inclusion criteria: \n\n All preterm (28 to 34 week gestation) very low birth weight (birth weight 750-1500grams.) infants born at AIIMS would be eligible for enrollment in the study. Of these infants, those who meet the following criteria would be enrolled. \n\n Cases: Preterm (28 to 34 week gestation) infants with birth weight between 750 and 1500 grams with shock in the first week of life requiring vasopressor therapy (dopamine or dobutamine or both in a dose of > 10 mcg/kg/min) \n\n Controls: Stable preterm (28 to 34 week gestation) infants with birth weight between 750 and 1500 grams who are matched for gestational age, birth weight, postnatal-age. \n\n ", - "exclusion_criteria": ": \n\n Major congenital malformations \n\n Mother receiving anticonvulsant / anti-tubercular drugs (rifampicin, isoniazid) \n\n Postnatal corticosteroid treatment \n\n Refusal to give consent", - "brief_summary": "The objective of this study is to estimate the prevalence of relative adrenal insufficiency in preterm very low birth weight infants with and without shock.", - "NCTID": "NCT00974337" - }, - { - "brief_title": "Latent Viral Infection of Lymphoid Cells in Idiopathic Nephrotic Syndrome", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['NEPHROSIS, LIPOID']", - "diseases_list": [ - "NEPHROSIS", - "LIPOID" - ], - "enrollment": "401.0", - "inclusion_criteria": "inclusion criteria: \n\n proteinuria over 0.25 g/mmol of creatinine with hypoalbuminemia below 30g/L for the case \n\n No history of renal disease \n\n Normal C3 and negativity for hepatitis B and C \n\n ", - "exclusion_criteria": ": \n\n no medical insurance \n\n inclusion in another study", - "brief_summary": "The primary purpose of the study is to evaluate the association of a latent infection of lymphoid cells during the first manifestation of steroid sensitive nephrite syndrome. The thirty nine units of general pediatrics and pediatric nephrite covering the parisian area will participate to the study. We speculate that hybridization of the genome, or a part of the genome, of a virus in lymphoid cells is responsible specific changes of genes expression, leading to the development of the disease.", - "NCTID": "NCT00577525" - }, - { - "brief_title": "Pilot Study of ACTH in the Treatment of Immunoglobulin A (IgA) Nephropathy at High Risk of Progression", - "phase": "Phase 3", - "drugs": "['ACTH (Acthar) Gel']", - "drugs_list": [ - "ACTH (Acthar) Gel" - ], - "diseases": "['Progressive IgA Nephropathy', 'Proteinuria']", - "diseases_list": [ - "Progressive IgA Nephropathy", - "Proteinuria" - ], - "enrollment": "20.0", - "inclusion_criteria": "Inclusion: \n\n Proteinuria > 1000 mg/24h despite documented ACEi/ARB therapy and adequate blood pressure control for > 3 months. \n\n Quantified 24h creatinine clearance > 30 ml/min/1.73m2. \n\n Blood pressure < 130/80 mmHg at > 75% of the readings. \n\n Henoch Schoenlein Purpura (HSP): Patients with biopsy proven IgA nephropathy and clinical features consistent with Henoch Schonlein Purpura will be considered eligible for the study. \n\n Patient must be able to receive injections to be enrolled in the study. \n\n Patient must have a kidney biopsy slide on file - that can be sent to Mayo Clinic. \n\n Exclusion: \n\n Clinical and histologic evidence of IgA predominant Lupus nephritis \n\n Patients with greater than 50% glomerular senescence or cortical scarring on renal biopsy. \n\n Serum Cr > 3.0 mg/dL or creatinine clearance glomerular filtration rate (GFR) < 30 ml/min at the time of screening \n\n Patients with history of Crohn's disease or Celiac Sprue \n\n Clinical evidence of cirrhosis, chronic active liver disease. \n\n Known infection with hepatitis B, hepatitis C, or HIV (Patients will be serologically screened prior to study entry (if the rest has been completed in the last two years, the patient will not have to undergo additional testing). \n\n Active systemic infection with bacterial, viral, fungal, or mycobacterial or atypical mycobacterial infections (excluding fungal infections of nail beds). \n\n Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening. \n\n Positive pregnancy test or breast feeding at time of study entry (urine pregnancy test will be performed for all women of childbearing potential no later than 7 days prior to treatment) or patients unwilling to comply with contraceptive measures as outlined above. \n\n Patients receiving therapy with oral prednisone or glucocorticoid equivalent in the past 3 months. \n\n Patients who had received immunosuppressive therapy including cyclophosphamide, mycophenolate mofetil (MMF), cyclosporine, tacrolimus or azathioprine in the last 6 months. \n\n Current or recent (within 30 days) exposure to any investigational drug. \n\n Patients having received a live vaccine within 28 days of study enrollment. \n\n Hemoglobin: < 8.5 gm/dL \n\n Platelets: < 100,000/mm \n\n Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 2.5 x Upper Limit of Normal \n\n Patients with anaphylaxis and/or known allergic reactions to ACTH \n\n Previous Treatment with ACTH \n\n History of drug, alcohol, or chemical abuse within 6 months prior to screening \n\n Concomitant or previous malignancies, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. \n\n History of psychiatric disorder that would interfere with normal participation in this protocol. \n\n Significant cardiac or pulmonary disease (including obstructive pulmonary disease). \n\n Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication. \n\n Inability to comply with study and follow-up procedures.", - "exclusion_criteria": "", - "brief_summary": "This study is designed to answer whether patients with progressive IgA nephropathy, who receive Acthar (ACTH) gel injection at a dose of 80 units subcutaneously twice weekly for 6 months is effective in inducing improvement in proteinuria and renal function.", - "NCTID": "NCT02282930" - } - ], - "2": [ - { - "brief_title": "Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery", - "phase": "Phase 3", - "drugs": "['fenoldopam (Corlopam)', 'placebo', 'ketanserin (Sufrexal)']", - "drugs_list": [ - "fenoldopam (Corlopam)", - "placebo", - "ketanserin (Sufrexal)" - ], - "diseases": "['Acute Renal Failure']", - "diseases_list": [ - "Acute Renal Failure" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n cardiac surgery \n\n at least one risk factor for acute renal failure: \n\n oliguria < 0.5 ml/kg/hour for over 3 hours despite adequate blood volume and furosemide intravenously \n\n at least 60 mg furosemide/12 hours iv to maintain diuresis > 1 ml/kg/hour \n\n ", - "exclusion_criteria": ": \n\n refused or none consent \n\n chronic renal failure with chronic renal replacement therapy \n\n chronic increase of serum creatinine > 2 mg/dl", - "brief_summary": "The purpose of the study is to compare the effect of fenoldopam and ketanserin on kidney function preservation in patients at high risk for renal failure after cardiac surgery. Acute, oliguric renal failure develops in up to 2% of patients undergoing cardiac surgery. Some of them require renal replacement therapy and despite that mortality in this group exceeds 30-60%. The investigators await that the use of fenoldopam and/or ketanserin may decrease the rate of severe renal failure.", - "NCTID": "NCT00557219" - }, - { - "brief_title": "Ketorolac in Postoperative Infants: Pharmacokinetics and Safety", - "phase": "Phase 3", - "drugs": "['Ketorolac Tromethamine 1 mg/kg', 'Ketorolac Tromethamine 0.5 mg/kg', 'Placebo']", - "drugs_list": [ - "Ketorolac Tromethamine 1 mg/kg", - "Ketorolac Tromethamine 0.5 mg/kg", - "Placebo" - ], - "diseases": "['Postoperative Pain in Infants']", - "diseases_list": [ - "Postoperative Pain in Infants" - ], - "enrollment": "77.0", - "inclusion_criteria": "inclusion criteria: \n\n Non-prematurely-born infants admitted to hospital following surgery ages 2-18 months, studied by age group 12-18 months, 6-12 months, < 6 months \n\n ", - "exclusion_criteria": ": \n\n Bleeding history in infant or family \n\n Coagulopathy \n\n Gastrointestinal bleeding history \n\n Renal or hepatic disease assessed by history and by pre-drug blood tests \n\n Premature birth (<36 weeks gestation)", - "brief_summary": "Infants handle ketorolac differently than adults. Study of handling of this pain medication given to infants following surgery. Detailed analysis of how the drug is eliminated from age 2 months to 18 months. Compared morphine use in infants who received the drug to the group getting placebo. Safety testing for kidney and liver function, breathing measured by continuous oximetry, and any bleeding issues.", - "NCTID": "NCT01260883" - } - ] - }, - { - "patient_id": "sigir-201419", - "patient": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", - "0": [ - { - "brief_title": "Study of the Efficiency of Esophageal Dilation on Patient With Eosinophilic Esophagitis", - "phase": "", - "drugs": "['Esophageal dilation', 'Steroid and Proton Pump Inhibitor Therapy']", - "drugs_list": [ - "Esophageal dilation", - "Steroid and Proton Pump Inhibitor Therapy" - ], - "diseases": "['Suspected Eosinophilic Esophagitis']", - "diseases_list": [ - "Suspected Eosinophilic Esophagitis" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female volunteers \u226518 years old. \n\n Patients with known or suspected Eosinophilic Esophagitis. \n\n Patients undergoing upper endoscopy for recent food impaction or complaint of dysphagia. \n\n ", - "exclusion_criteria": ": \n\n Use of oral corticosteroids. \n\n Significant medical conditions that in the investigator's judgment would compromise the subject's health and safety. \n\n Contraindication to esophageal dilation based on investigator's judgment. \n\n Esophageal motility abnormalities not thought to be related to Eosinophilic Esophagitis.", - "brief_summary": "This study is for patients who have had a food impaction and/or difficulty swallowing, who are scheduled to have endoscopy, biopsy and possibly dilatation (stretching) of the esophagus.~Standard treatment for people who have food impaction and difficulty swallowing is endoscopy to view the esophagus, tissue biopsies of the lining of the esophagus for diagnosis, and drug therapy including steroids and drugs used to treat reflux disease. Early dilatation or stretching of the esophagus may be done at this time but not always. Some doctors prefer to wait and see if the drugs are affective.~It is not known if dilating the esophagus early in treatment adds benefit. Therefore, we are doing this study to compare the two methods of treatment. We will compare two groups: one group will have dilatation performed during the first endoscopy and one group will not have dilatation performed during endoscopy. We will see if dilatation helps prevent food impaction and improves swallowing.~Another purpose of this study is to learn more about the causes of swallowing problems, thus extra biopsies will be taken of the esophagus and store them for future research.", - "NCTID": "NCT00880906" - }, - { - "brief_title": "Safety and Efficacy of the Swallow Expansion Device (SED) for Improvement of Swallowing in Patients", - "phase": "", - "drugs": "['Swallowing Expansion Device']", - "drugs_list": [ - "Swallowing Expansion Device" - ], - "diseases": "['Oropharyngeal Dysphagia (OPD)', 'Dysphagia']", - "diseases_list": [ - "Oropharyngeal Dysphagia (OPD)", - "Dysphagia" - ], - "enrollment": "5.0", - "inclusion_criteria": "inclusion criteria: \n\n Profound oropharyngeal feeding tube dependent dysphagia of greater than 12 months duration, as documented by the prevalence of aspiration on fluoroscopic swallow study. \n\n Must be receiving 100% of nutritional requirements by enterogastric tube. \n\n 18 years of age and older, acceptable forms of documentation for verification of age include birth certificate, passport, and/or driver's license. \n\n Diminished upper esophageal sphincter opening defined as less than .55 cm for individuals under 65 years of age and less than .40 cm for individuals over 65 years of age on fluoroscopic swallow study. \n\n Failure of > 3 months of dysphagia therapy within 3 months of study enrollment. \n\n No documented history of noncompliance with feeding recommendations. \n\n Cognition that is within normal limits, as evidenced by an Abbreviated Mental Test Score (AMTS) score greater than 6. \n\n Manual dexterity that is within normal limits for age, sex, and hand, as evaluated by a Block and Box Test (BBT). \n\n Physical strength to pull the SED forward, as evidenced by the ability to lift a 5 lb weight off of a table and keep it elevated for 10 seconds. \n\n Ability to understand the informed consent and comply with follow-up, as evidenced by appropriate questions, responses, and comments during the initial evaluations and a normal Abbreviated Mental Test Score. \n\n Bilateral vocal fold mobility or unilateral vocal fold immobility in which the individual is able to attain complete glottic closure as evidenced on endoscopy. \n\n ", - "exclusion_criteria": ": \n\n Profound oropharyngeal feeding tube dependent dysphagia < 12 months duration. \n\n Esophageal phase dysphagia as defined as personal history and/or documented diagnosis of esophageal dysmotility, hiatal hernia, stricture, eosinophilic esophagitis, erosive peptic esophagitis, and/or systemic disease affecting the esophagus. \n\n Able to safely consume any food or liquid by mouth, as documented by fluoroscopic swallow study. \n\n Normal UES opening, as evidenced by UES opening greater than .55 cm for individuals under 65 years of age and greater than .40 cm for individuals over 65 years of age on fluoroscopic swallow study. \n\n Currently pregnant, as evidenced by a positive result on a pregnancy test if the patient is within child bearing age (younger than 60 years of age). \n\n 17 years of age and younger, acceptable forms of documentation for verification of age include birth certificate, passport, and/or license. \n\n Success full receipt of dysphagia therapy or < 3 months of dysphagia therapy within 3 months of study enrollment. \n\n Lack of manual dexterity to operate swallowing expansion device as determined by a Block and Box Test (BBT) score below the normal limits per age, sex, and hand. \n\n Inability to lift a 5 lb weight off of a table and keep it elevated for 10 seconds. \n\n Lack of cognitive ability to operate swallowing expansion device or provide informed consent as evidenced by an Abbreviated Mental Test Score (AMTS) score less than 6. \n\n Active tumor involving the cricoid or laryngeal cartilage. \n\n Known allergic reaction to titanium as evidenced by personal history of allergic or adverse reaction to titanium. \n\n Infection of cartilage, head, and/or neck at time of evaluation and/or implantation as documented by recent imaging study or abnormal physical examination. \n\n Presence of a tracheotomy tube or airway obstruction necessitating a tracheotomy tube. \n\n A documented history of noncompliance with recommendations to take nothing by mouth. \n\n Patients with an insensate larynx. Laryngeal sensation will be assessed with laryngopharyngeal sensory testing. An insensate larynx is defined as a laryngopharyngeal sensory threshold < 6 mmHg air pulse pressure or a complete absence of the laryngeal adductor reflex on palpation of the arytenoid with a flexible laryngoscope. \n\n Patients with a current, at the time of evaluation, and/or history of Zenker's diverticulum. \n\n Patients with sialorrhea at the time of evaluation with or without oral commissure incompetence. \n\n Patients with profound xerostomia at the time of evaluation. \n\n Patients with orocutaneous or pharyngocutaneous fistulae at the time of evaluation. \n\n Patients with a current, at the time of evaluation, and/or history of immunosuppression, as defined by the patient having a diagnosed immunodeficiency disorder or on immunosuppressive medication. \n\n Patients with a current, at the time of evaluation, and/or history of coagulopathy, as defined by the patient having a diagnosed coagulation disorder or on anticoagulation medication (e.g., baby aspirin, over-the-counter non-steroidal anti-inflammatories, herbal agents, and warfarin, etc.) that cannot be temporarily stopped for the procedure. \n\n Patients taking sedatives, narcotics, muscle-relaxants, anxiolytics, medical marijuana, alcohol, nicotine, medicinal nicotine, or other mind-altering medications that may affect safe patient use of the swallowing device. \n\n Patients taking antifibrotic medications. \n\n Patients with bilateral vocal fold immobility in any position, as evidenced on endoscopy. \n\n Patients with unilateral vocal fold immobility and unable to attain complete glottic closure, as evidenced on endoscopy. \n\n Patients with current, at the time of evaluation, and/or documented history of subglottic stenosis, as evidenced on endoscopy. \n\n Patients with current, at the time of evaluation, and/or documented history of airway obstruction, as evidenced on endoscopy. \n\n Patients with a life expectancy < 2 years.", - "brief_summary": "Biomedical devices, such as artificial joints and pacemakers, are accepted and commonly used in medicine. While great progress in biomedical devices has been made for many other disorders, there is currently no device available to assist with the act of deglutition. The investigators have developed a biomedical device (Swallow Expansion Device, SED) that assists with swallowing by mechanically opening the upper esophageal sphincter and allowing food and liquid to safely enter the esophagus. The SED has proven safe in cadaver and live animal studies (Belafsky, 2010).", - "NCTID": "NCT02296528" - }, - { - "brief_title": "Phase II Study of Icotinib With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer", - "phase": "Phase 2", - "drugs": "['Icotinib', 'Thoracic radiotherapy']", - "drugs_list": [ - "Icotinib", - "Thoracic radiotherapy" - ], - "diseases": "['Esophageal Cancer']", - "diseases_list": [ - "Esophageal Cancer" - ], - "enrollment": "130.0", - "inclusion_criteria": "inclusion criteria: \n\n Pathologically confirmed esophageal carcinoma \n\n Stage I\uff5eIva By EUS and CT/MRI, without contraindication for radical radiotherapy \n\n Aged \u2265 70 and < 85 years, behavioral status evaluation ECOG scores 0-2 \n\n In 7 days after being screened, subjects should follow the status: WBC \u2265 3.0 x 10^9/L; ANC \u2265 1.5x 10^9/L; PLT \u2265 80 x 10^9/L; Hb \u2265 90 g/L; serum Cr \u2264 ULN; serum bilirubin \u2264 1.5 ULN; ALT/AST \u2264 1.5 ULN \n\n Subjects should sign for the informed consent \n\n Subjects should perform good compliance \n\n ", - "exclusion_criteria": ": \n\n Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy \n\n Complete obstruction of the esophagus, or patients who have the potential to develop perforation \n\n Patients with a history of malignancy (except that skin carcinomas or in situ breast cancer, oral cancer and cervical cancer with expected survival \u22652 years \n\n Patients who have multiple foci esophageal carcinomas \n\n Patients who are/were given any other medicine tests currently/in last 4 weeks \n\n Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines \n\n Patients who have complications as following: \n\n (1) Uncontrolled angina and heart failure, have a history of hospitalization in 3 months; (2) A history of myocardial infarction in the past 6 months; (3) There is a need for antibiotic treatment of acute bacterial or fungal infection; (4) Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization; (5) Drug addiction, alcoholism and AIDS disease or long-term virus carriers; (6) Uncontrollable seizures, or loss of insight because of mental illness.", - "brief_summary": "To investigate the efficacy and toxicity of EGFR tyrosine-kinase inhibitor (Icotinib) with concurrent radiotherapy in older patients with esophageal cancer.", - "NCTID": "NCT02375581" - }, - { - "brief_title": "Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal Cancer", - "phase": "Phase 2", - "drugs": "['gefitinib', 'Thoracic radiotherapy']", - "drugs_list": [ - "gefitinib", - "Thoracic radiotherapy" - ], - "diseases": "['Esophageal Cancer']", - "diseases_list": [ - "Esophageal Cancer" - ], - "enrollment": "70.0", - "inclusion_criteria": "inclusion criteria: \n\n Histologically documented diagnosis of esophageal Cancer \n\n Disease must be encompassed in a radiotherapy field.Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible \n\n age:70-85 years \n\n Written informed consent. \n\n Performance status of 0 to 2 \n\n Neutrophil count >1.5 x 10 to the 9th power/L and platelets > 100 x 10 to the 9th power/L. \n\n Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement \n\n Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN) \n\n ", - "exclusion_criteria": ": \n\n Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi. \n\n Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible). \n\n Prior systemic chemotherapy or radiation therapy for esophageal cancer", - "brief_summary": "Elderly patients with esophageal cancer will receive thoracic radiation therapy 54-60Gy over 30 fractions, and concurrent with Gefitinib.", - "NCTID": "NCT01291823" - }, - { - "brief_title": "Efficacy and Safety of Alginos Oral Suspension to Treat Laryngopharyngeal Reflux", - "phase": "Phase 3", - "drugs": "['Sodium alginate', 'Placebo']", - "drugs_list": [ - "Sodium alginate", - "Placebo" - ], - "diseases": "['Laryngopharyngeal Reflux']", - "diseases_list": [ - "Laryngopharyngeal Reflux" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with age of 12-75 years old (inclusive) \n\n Patients with at least one symptom consistent with LPR, including hoarseness, throat clearing, throat pain, globus sensation in the throat, or chronic cough \u2267 4 weeks before entering study \n\n Patients with a total reflux symptom index (RSI) >10 (based on a self-administered 9-item questionnaire of voice/throat complaints) \n\n Patients with a total reflux finding score (RFS) >5 (based on a laryngoscopic examination by investigators) \n\n Patients or their legal representatives have signed the informed consent form \n\n ", - "exclusion_criteria": ": \n\n Patients with viral or bacterial laryngitis, or occupational exposures causing laryngitis \n\n Patients with erosive GERD as evidenced by upper GI endoscopy \n\n Patients with laryngeal or hypopharyngeal cancer, esophageal or gastric cancer, , or with history of neck radiation therapy \n\n Patients with history of uncontrolled hypertension or moderate to severe renal impairment \n\n Patients with history of esophageal or gastric surgery \n\n Patients with active pulmonary infection (pneumonia, tuberculosis) as evidenced by chest X-ray \n\n Patients with endotracheal tube intubation within 2 months before entering study \n\n Patients had taken any alginate preparations within 2 days; H2-blocker, prokinetic agent or antacid within 7 days; or proton pump inhibitors (PPIs) within 14 days before screening \n\n Patients with a history of allergy to the study drugs or their related compounds \n\n Patients with a history of alcohol or drug abuse, or with any psychiatric disease \n\n Patients participated any investigational drug trial within 4 weeks before entering the study \n\n Patients with any other conditions or diseases that investigator considers it is not appropriate to enter the study", - "brief_summary": "Laryngopharyngeal reflux (LPR), the backflow of gastric acid into the larynx and hypopharynx, is a contributing factor to hoarseness, throat clearing, throat pain, and globus sensation. The therapeutic effect of proton pump inhibitors (PPIs) is controversial because a high placebo effect can be observed. Sodium Alginate is an effective medication indicated for symptomatic treatment of gastroesophageal reflux. This randomized, double-blind, placebo-controlled study aims to evaluate the efficacy and safety profile of sodium alginates oral suspension (50 mg/ml) 20 ml 3 times daily for the treatment of with LPR patients in Taiwan. Efficacy assessments include mean reduction in the total reflux symptom index (RSI) score after 4 and 8 weeks treatment, mean reduction in the total reflux finding score (RFS) after 4 and 8 weeks treatment, mean changes in the total numbers of reflux episodes as measured by 24-hour ambulatory combined impedance-pH monitoring after 1 day and 8 weeks treatment. Safety assessments include incidence of adverse events. The study hypothesis is sodium alginate is superior over placebo in relieving LPR symptoms.", - "NCTID": "NCT01450748" - }, - { - "brief_title": "DYsphAgia In Mechanically Ventilated ICU patientS", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Deglutition Disorders']", - "diseases_list": [ - "Deglutition Disorders" - ], - "enrollment": "2000.0", - "inclusion_criteria": "inclusion criteria: all adult ICU patients post mechanical ventilation (observational analysis) \n\n ", - "exclusion_criteria": ": \n\n patients prone to die / moribund patients/ or dying patients \n\n patients post oesophageal resection / with oesophageal rupture", - "brief_summary": "Dysphagia significantly contributes to morbidity and mortality in non-critically ill patients (as e.g. in stroke). Long term consequences of dysphagia include, among others, malnutrition, prolonged enteral tube feeding and increased risk of aspiration. In the present observational analysis, the investigators aim to elucidate the incidence and the impact of dysphagia on the clinical course of a mixed population of ICU patients post invasive mechanical ventilation.", - "NCTID": "NCT02333201" - }, - { - "brief_title": "Treatment of Dysphagia in Oculopharyngeal Muscular Dystrophy by Autologous Transplantation of Myoblasts", - "phase": "Phase 2", - "drugs": "['Autologous myoblasts transplantation and myotomy']", - "drugs_list": [ - "Autologous myoblasts transplantation and myotomy" - ], - "diseases": "['Muscular Dystrophy, Oculopharyngeal']", - "diseases_list": [ - "Muscular Dystrophy", - "Oculopharyngeal" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Man or woman <18-75> years old \n\n Oculopharyngeal muscular dystrophy confirmed by genetic diagnosis (mutation of the GCG) on the chromosome 14) \n\n Oculopharyngeal muscular dystrophy with UES dysfunction \n\n salivary or alimentary stasis at fibroscopy of swallowing above the UES, \n\n decreased opening of the UES at videofluoroscopy of swallowing A decreased of the pharyngeal propulsion may be associated Written consent of the patient \n\n ", - "exclusion_criteria": ": \n\n History of myotomy of the UES in the context of the Oculopharyngeal muscular \n\n Dystrophy; \n\n HIV, hepatitis B or C tuberculosis); \n\n Lupus, rheumatoid polyarthritis, sarco\u00efdosis, collagenosis) ; \n\n Other neuromuscular diseases ; \n\n History of malignant tumor ; \n\n History of neck radiotherapy ; \n\n Renal failure (creatinine clearance <60ml/min) \n\n Liver failure ; \n\n Pregnancy ; \n\n Follow up less than 24 months: \n\n Patients who refuse to sign the consent; \n\n No social security.", - "brief_summary": "The OCULO-Pharyngeal Muscular Dystrophy (OPMD) is a late onset hereditary muscle disease which is characterised by the selective affection of the pharyngeal muscles resulting in swallowing disorders, and by a ptosis from the dysfunction of the levator palpebral superiors muscles. Swallowing disorders are determinant in the prognosis of the disease, and potentially life-threatening deglutition, due to aspiration and denutrition. Degenerative dystrophy of the pharyngeal muscles causes difficulties to prepulse the food bolus in the pharynx, and the decreased relaxation of the cricopharyngeal muscle induced by the disease leads to blockage of food in the upper esophageal sphincter. The most common treatment for the dysphagia in OPMD is a myotomy of the upper esophageal sphincter muscles. However, although this will relax the constriction of the upper esophageal sphincter muscles and improve transitory the swallowing, it will not prevent the progressive degradation of the pharyngeal muscles. This progressive loss of contractility will eventually result in aspiration and severe difficulty in swallowing, increasing risk of aspiration pneumonia and severe weight loss which are the most common causes of mortality in OPMD patients.~The protocol which we are proposing is a graft of autologous cell muscles (myoblasts) isolated from unaffected limb muscles into the pharyngeal muscles of patients diagnosed as suffering from OPMD. Our aim is to improve both swallowing and the contractile deficit generated by the dystrophic pharyngeal muscles. A myotomy of the upper esophageal sphincter will be carried out at the same time as the myoblast transplantation, since we have already validated the improvement resulting from this surgery. Advantages of this new therapy in OPMD is the autograft, without risks of rejection, and the graft of myoblasts into the dystrophic pharyngeal muscles, above the myotomy of the upper esophageal sphincter muscles.~This model of cellular therapy has been studied through a preclinical study performed in dogs, allowing to valid the procedure and its safety, as well as to study the survival myoblasts grafted in the pharyngeal muscles.~This protocol is proposed for OPMD patients; it is firstly a safety study of both autograft and surgical procedure. In addition, the autograft may improve the swallowing disorders and life-threatening complications induced by aspiration and weight loss, resulting in a potential individual benefit.", - "NCTID": "NCT00773227" - }, - { - "brief_title": "Combined NMES,FEES and Traditional Swallowing Rehabilitation in the Treatment of Stroke-related Dysphagia", - "phase": "", - "drugs": "['the combination group']", - "drugs_list": [ - "the combination group" - ], - "diseases": "['Stroke']", - "diseases_list": [ - "Stroke" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n age between 20-85 years old \n\n first-time stroke confirmed by computed tomography or magnetic resonance image \n\n dysphagia > 3 weeks, with preservation of the swallowing reflex \n\n currently on a restricted diet, with a Functional Oral Intake Scale (FOIS) score of 5 or less \n\n Mini-Mental State Examination (MMSE)> 21 \n\n no obvious mental depression, receptive aphasia or cognitive impairment \n\n ", - "exclusion_criteria": ": \n\n progressive cerebrovascular disease or other neurologic diseases \n\n unstable cardiopulmonary status, serious psychologic disorder or epilepsy; \n\n tumors, extensive surgery or radiotherapy of the head and neck region \n\n cardiac pacemakers \n\n swallowing therapy within 2 months before participation", - "brief_summary": "The investigators aimed to evaluate effects of combined NMES, FEES and traditional swallowing rehabilitation in stroke patients with moderate-to-severe dysphagia.", - "NCTID": "NCT01731847" - }, - { - "brief_title": "A Study to Evaluate the Effect of a Medicine on Gastric Functions in Healthy Volunteers.", - "phase": "Phase 2; Phase 3", - "drugs": "['Itopride']", - "drugs_list": [ - "Itopride" - ], - "diseases": "['Healthy Volunteers']", - "diseases_list": [ - "Healthy Volunteers" - ], - "enrollment": "45.0", - "inclusion_criteria": "Non-pregnant, non-breastfeeding females; \n\n 18- 45 years old \n\n Body mass index between 20 and 32 kg/m2 \n\n No alarm indicators on clinical assessment (weight loss of more than 7kg, bleeding, recent recurrent vomiting, progressive dysphagia). \n\n No history suggestive of small bowel obstruction", - "exclusion_criteria": "", - "brief_summary": "A 7 day study which involves 2 nutrient drink tests, an ECG, a Scintigraphy scan, and a Sect scan. This study requires the participant to make 4 visits to the GCRC in the Charlton building but no overnight stays.", - "NCTID": "NCT00308399" - }, - { - "brief_title": "Adjunctive Neuromuscular Electrical Stimulation for the Rehabilitation of Swallowing", - "phase": "Phase 2; Phase 3", - "drugs": "['swallowing therapy']", - "drugs_list": [ - "swallowing therapy" - ], - "diseases": "['Dysphagia']", - "diseases_list": [ - "Dysphagia" - ], - "enrollment": "53.0", - "inclusion_criteria": "inclusion criteria: \n\n Stroke identified by neurological and radiological examination \n\n Oropharyngeal dysphagia as confirmed by clinical and radiological examination \n\n No prior history of oropharyngeal dysphagia by patient and/or caregiver report \n\n No previous head/neck surgery or trauma that may impact swallowing ability \n\n No other/concomitant neurological disorders (e.g. Parkinson's disease) that would impact oropharyngeal swallowing ability. This does not include post-stroke deficits. \n\n Physician and patient/family agreement to participate. \n\n ", - "exclusion_criteria": ": \n\n Exposed to previous behavioral or NMES swallowing therapy within 6 months of admission \n\n Presence of progressive neurological disorder, such as ALS; Parkinson's or other neurologic disorders within the last 6 months; \n\n History of neurosurgery (either ablative or stimulatory), encephalitis or significant head trauma. \n\n History of a significant medical condition such as heart, liver, or renal disease; history or evidence of malignancy within the past 5 years other than excised basal cell carcinoma. \n\n Because of FDA Warnings, patients with cardiac demand pace makers will be excluded. \n\n Patients with evidence of significant cognitive impairment or dementia as reflected in a Mini-Mental test less than 23 and/or a score of 50% or less on the comprehension quotient on the Western Aphasia Battery.", - "brief_summary": "Neuromuscular Electrical stimulation (NMES) for swallowing has recently been proposed for the treatment of dysphagia post stroke and is clinically receiving favor as a treatment modality, in the absence of strong research support. This study aims to investigate the effect of NMES therapy for dysphagia upon recovery of swallowing function following stroke. The study will follow a pilot randomized controlled trial design. Fifty one patients admitted to a sub-acute rehabilitation facility will be clinically screened for dysphagia, and randomized into one of three groups, NMES, sham NMES or usual care -behavioral swallowing therapy arm. All patients will be treated for one hour per day for 3 weeks, and their progress and outcome will be monitored. The results will add to the preliminary data on the effectiveness of this form of swallowing treatment for patients following stroke, and has the potential to enable more efficient allocation of resources to post-acute rehabilitation and thus benefit afforded to stroke patients, and the community.", - "NCTID": "NCT01279824" - }, - { - "brief_title": "Volitional Swallowing in Stroke Patients With Chronic Dysphagia", - "phase": "Phase 2", - "drugs": "['Swallowing Training']", - "drugs_list": [ - "Swallowing Training" - ], - "diseases": "['Stroke', 'Dysphagia']", - "diseases_list": [ - "Stroke", - "Dysphagia" - ], - "enrollment": "34.0", - "inclusion_criteria": "inclusion criteria FOR PATIENTS WITH CHRONIC PHARYNGEAL DYSPHAGIA DUE TO BRAIN INJURY \n\n Inclusive ages of 20 to 90 \n\n History of brain injury. No specific localization of brain injury or brain injuyr type will be required for inclusion. \n\n Evidence of pharyngeal phase dysphagia following the brain injury that places the patient at risk for aspiration. \n\n Risk for aspiration or frank aspiration will be based on the medical history and evidence from a videofluoroscopic swallowing study. Absence of aspiration is not cause for exclusion if the risk for aspiration is deemed present due to impaired pharyngeal phase of swallowing as judged by an expert experienced in the evaluation of dysphagia. The patient may demonstrate evidence of aspiration or the risk for aspiration on any consistency, perhaps secondary to pharyngeal retention. Aspiration is defined as passage of food, liquid, or secretions into the trachea below the level of the vocal folds. If the patient does not demonstrate either aspiration or a risk for aspiration in previous assessment or during preliminary studies, they will be excluded from participation. \n\n Impaired pharyngeal phase of swallowing may be evidenced by pharyngeal delay, reduced hyolaryngeal elevation, reduced laryngeal closure, and reduced pharyngeal clearance of the bolus. Signs of pharyngeal delay include hesitation of the material in the vallecula at times with spill over into the pyriform sinuses. Normally the pharyngeal phase of swallowing should be less than 1 second from onset until the passage of the bolus into the posterior pharynx. Delay will be defined as the time from the entry of the head of the bolus into the oropharynx at the posterior tongue and the lower posterior edge of the angle of the mandible, to the beginning of elevation of the hyoid bone and larynx. Reduced hyolaryngeal elevation will be identified when the larynx is not protected and remains open to the bolus during a swallow on videoendoscopy. Reduced pharyngeal clearance will be seen during videoendoscopy when the bolus remains in the vallecula and/or pyriform sinuses. \n\n Chronic dysphagia can occur as a result of stroke or other brain injury. Lesions in either hemisphere and/or the brain stem may cause dysphagia and aspiration. \n\n Duration of 4 months or greater post-onset of brain injury and dysphagia \n\n Participants may have other health problems such as diabetes mellitus, arteriosclerotic coronary vascular disease and a history of smoking. These will not be cause for automatic exclusion, but will be examined on an individual basis by the otolaryngologist in determining the potential risk and benefit to the individual participant. \n\n Prior history of tracheostomy or current tracheostomy is not a cause for exclusion. The otolaryngologist will determine if an individual with tracheostomy is an appropriate candidate for the study. \n\n Patients should be on a restricted diet level. This may include a diet level restriction such as pureed or chopped solids, restrictions to certain solid food items, or thickened liquids. Patients may be receiving alternate means of nutrition and hydration (PEG, PEJ, PPN/TPN) for some or all of their nutritional intake, or they may be receiving all of their nutritional intake orally. \n\n Adequate cognitive skills as demonstrated by a Mini-Mental State Examination (MMSE) score greater than or equal to 23 \n\n Stable medical status. \n\n To determine if a patient has stable vital signs prior to admission, the patient will be asked to provide a letter from their physician stating that the patient is medically stable and may participate in the study. \n\n ", - "exclusion_criteria": " FOR PATIENTS WITH CHRONIC PHARYNGEAL DYSPHAGIA DUE TO BRAIN INJURY \n\n History of epileptic seizure \n\n If subject is participating in TMS, history of cardiac rhythm condition (including heart murmur or cardiac arrhythmia) or a cardiac pacemaker in place \n\n History of progressive neurodegenerative disorders, such as progressive dementia, Parkinson's Disease, multiple sclerosis, and amyotrophic lateral sclerosis \n\n History of malignant brain tumor \n\n Severe oral phase swallowing deficits that prevent bolus retention in the oral cavity \n\n Esophageal motility disorder preventing food or liquid from adequately moving through the esophagus into the stomach \n\n Pregnant women will be excluded from participation because the study involves radiation exposure and MRI scanning (for anatomical co-registration purposes). \n\n Current psychiatric disorder other than depression, as evidenced by being under the care of a psychiatrist, or on medications for treatment of a psychiatric disorder. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, schizophrenia or bipolar disorder. \n\n Presence of metal in the body (prostheses, electrodes, shrapnel, aneurism clips, other medical hardware) and presence of certain tattoos with ferromagnetic metal or permanent makeup will exclude subjects due to the exposure to high magnetic force through MRI/fMRI/TMS procedures due to the exposure to high magnetic force in both procedures. Subjects who were metal workers as a previous occupation will also be excluded only from MRI/TMS procedures due to the possibility of unknown/undetected metal in their body. Subjects who have MRI-compatible metal implants (e.g. titanium implants) may still be considered as candidates for MRI study, pending review and discussion of documentation regarding the device material and safety of the device in a 3T scanner by the Principal Investigator, LSS staff physician, and an MRI technologist. \n\n No person with the presence of broken skin in the area of the tDCS or TMS stimulating electrodes will participate in tDCS or TMS. \n\n Inability to coordinate button or switch press with swallow (as determined during screening) will exclude patients from participating \n\n Presence of severe pulmonary disease, defined in pulmonary testing by a Forced Expiratory Volume in 1 sec (FEV1) less than 50% of the predicted value based on sex, age and height may exclude patients from participating at the discretion of the Internal Medicine Service. \n\n inclusion criteria FOR HEALTHY VOLUNTEERS (FOR PILOT STUDY) \n\n Inclusive ages of 18 to 75 \n\n The healthy volunteers will be without cardiac, neurological, psychiatric, speech or swallowing problems as determined by medical history and examination by a physician \n\n ", - "brief_summary": "This study will compare several techniques designed to improve the ability to swallow in stroke patients with chronic dysphagia (difficulty swallowing).~Healthy volunteers 20 to 60 years of age and people 20 to 90 years of age who have had a stroke resulting in swallowing problems may be eligible for this study. Volunteers are screened with a medical history, physical examination, and urine test for women to rule out pregnancy. Stroke patients are screened additionally with a chest x-ray, physical examination, cognitive screening, swallowing questionnaires, nasoendoscopy (examination of the nasal passages in the back of the throat using a lighted telescopic instrument) and FEESST (passage of a thin, flexible telescope through the nose to the voice box), videofluoroscopy (x-ray of the head and neck during swallowing) and button press training (learning how to press a button on a table in coordination with swallowing).~All participants undergo the following procedures:~Transcranial magnetic stimulation (TMS): A metal coil is placed on the head and sends a pulse of energy to the brain through the scalp. The muscle response to the pulse is recorded from the muscles in the throat that are associated with swallowing.~Electromyography: A needle is used to insert tiny wires in specific muscles of the throat to record the muscle response to the TMS pulses.~Magnetic resonance imaging (MRI): During brain MRI scanning, subjects lie quietly and images of the brain are taken.~In addition to the above tests, stroke patients undergo the following:~Water test: The subject swallows a small amount of water and the number of times required to clear the throat or cough is counted. This test is repeated five times.~Experimental training. Subjects have a total of 12 60-minute training sessions, one session a day for up to 5 sessions a week.~Button press training: The subject swallows small amounts of water. A device placed on the throat senses when swallowing occurs. The subject learns how to coordinate pressing a button on a table in coordination with swallowing.~Vibrotactile stimulator training: A device that uses a buzzing vibration is placed on the throat at times during the swallowing training.~Transcranial direct current stimulation (tDCS): Wires attached to sponge electrodes are placed on the scalp and over the eye. Small electric currents are delivered to areas of the brain involved with swallowing. This is done at times during the swallowing training.~Participants may receive one of several combinations of training approaches; all receive the volitional (button-press) training. Within 5 days of completing training, subjects repeat the tests. TMS, MRI, MEG and x-ray study of swallowing function are also repeated to see if any changes have occurred in the brain or in the ability to swallow after training. Patients are contacted by telephone and in writing 3 and 6 months after training for follow-up on their swallowing status and oral intake.", - "NCTID": "NCT00306501" - }, - { - "brief_title": "Neuromuscular Electrical Stimulation (NMES) Treatment Technique Therapy in the Management of Young Infants With Severe Dysphagia", - "phase": "Phase 2", - "drugs": "['Neuromuscular electrical stimulation (NMES)']", - "drugs_list": [ - "Neuromuscular electrical stimulation (NMES)" - ], - "diseases": "['Dysphagia']", - "diseases_list": [ - "Dysphagia" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Infants with severe dysphagia on VFFS as defined by dysphagia resulting in aspiration with swallow of at least 2 food textures (e.g. thin and thick liquid). \n\n We will include children with dysphagia due to a central neurologic deficit. The neurologic diagnosis will be based on the diagnosis from the treating physician. \n\n ", - "exclusion_criteria": ": \n\n Infants with a known or suspected neurodegenerative or peripheral neuromuscular condition or a medical condition that is a contraindication for NMES treatment (tumours in the neck region and neck soft tissue infections). \n\n Children with neurodegenerative disorders have been excluded as their natural history of dysphagia would be different from those with a static neurologic disorder.", - "brief_summary": "The goal of this study is to obtain data that well help inform the feasibility and design of a randomized control trial of the therapeutic Neuromuscular Electrical Stimulation (NMES) technique in improving the swallowing function of young infants presenting with severe dysphagia.", - "NCTID": "NCT01723358" - }, - { - "brief_title": "Effect of Saline Lubrication on Post-intubation Complications", - "phase": "", - "drugs": "['Saline group', 'Dry group']", - "drugs_list": [ - "Saline group", - "Dry group" - ], - "diseases": "['Postoperative Sore Throat']", - "diseases_list": [ - "Postoperative Sore Throat" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n patients aged between 20-80 years who were scheduled for surgery under general anesthesia requiring orotracheal intubation \n\n ", - "exclusion_criteria": ": \n\n history of gastroesophageal reflux disease (GERD) \n\n congenital or acquired abnormalities of the upper airway such as tumor, polyp, trauma, abscess, inflammation, infection, or foreign bodies \n\n previous airway surgery; increased risk of aspiration \n\n coagulation disorders \n\n previous history of difficult intubation or conditions with expected difficult airway including Mallampati classification \u2265 3 or thyromental distance < 6.5 cm \n\n Using the other intubation devices beyond the direct laryngoscopy such as lighted stylet or fiberoptic bronchoscopy \n\n symptoms of sore throat or upper respiratory tract infection \n\n expected to place nasogastric tube during perioperative period \n\n requiring nasotracheal intubation", - "brief_summary": "The purpose of this study is to evaluate the influence of none-lubricated dry tube on the incidence of Postoperative Sore Throat (POST) after general anesthesia with endotracheal intubation.", - "NCTID": "NCT02492646" - }, - { - "brief_title": "The Effects of Cold Liquids on the Swallowing Mechanism in Preterm Infants", - "phase": "", - "drugs": "['Cold Thin Liquid Barium']", - "drugs_list": [ - "Cold Thin Liquid Barium" - ], - "diseases": "['Dysphagia']", - "diseases_list": [ - "Dysphagia" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Infants born prematurely, as defined by birth at less than 37 weeks gestational age, referred for a videofluoroscopic swallow study (VFSS) due to suspected pharyngeal phase dysphagia. \n\n ", - "exclusion_criteria": ": \n\n Infants born prematurely with a corrected gestational age of 43 weeks or greater.", - "brief_summary": "The purpose of this study is to see if cold liquids improve the swallowing mechanisms in premature infants with swallowing difficulties (dysphagia). The only way to objectively diagnose dysphagia is by having that infant undergo a Video Fluoroscopic Swallow Study (VFSS), which allows direct visualization of the liquid bolus (barium) in real time. Infants suspected of having dysphagia and who are referred for a VFSS will be recruited for this study. Once consented, the infant will undergo a standard VFSS. If that infant is diagnosed with dysphagia, the study protocol will begin by keeping the infant the same position and feeding them cold liquid barium from an identical bottle. A total of 5 swallows will be visualized, which adds approximately 5-10 seconds to the study. Both the standard swallows and the study swallows will be recorded for analysis and comparison. It is hypothesized that the study swallows will have less deficits than the standard swallows. If an infant's standard VFSS does not indicate dysphagia, that infant will no longer be eligible for this study.", - "NCTID": "NCT01863264" - }, - { - "brief_title": "A Study of BI 853520 in Patients With Various Types of Advanced or Metastatic Cancer", - "phase": "Phase 1", - "drugs": "['BI 853520']", - "drugs_list": [ - "BI 853520" - ], - "diseases": "['Neoplasms']", - "diseases_list": [ - "Neoplasms" - ], - "enrollment": "96.0", - "inclusion_criteria": "inclusion criteria: \n\n inclusion criteria \n\n Patients with a confirmed diagnosis of advanced, measurable or evaluable, nonresectable and/or metastatic non-hematologic malignancy, which has shown to be progressive in the last 6 months as demonstrated by serial imaging \n\n Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to established treatment options \n\n Tumour tissue must be available for the determination of E-cadherin expression (archived tissue or fresh biopsy). \n\n Recovery from reversible toxicities (alopecia excluded) of prior anti-cancer therapies (CTCAE grade < 2) \n\n Age = 18 years \n\n Life expectancy = 3 months \n\n Written informed consent in accordance with International Conference on Harmonisation/Good Clinical Practice (ICH/GCP) and local legislation, including consent for PK samples, for using an archived tumour sample for determination of Ecadherin status, for reviewing previous tumour scans (and for providing skin biopsies, in patients in dose finding phase enrolled before protocol amendment 03) \n\n Eastern Cooperative Oncology Group (ECOG), R01-0787) performance score 0-1 \n\n Additional inclusion criteria in the expansion phase: \n\n Patients must have measurable progressive disease within the last 6 months, according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria (version 1.1, R09-0262) \n\n deleted \n\n Patients must be willing to provide paired tumour biopsies for PD determination. Refer to section 5.6.3 \n\n Patients should fit into one of the categories described below: \n\n I. Metastatic adenocarcinoma of the pancreas Patients should have preferably received at least one line of systemic treatment for metastatic disease and preferably not more than 2 prior regimens for metastatic disease. \n\n II. Platinum-resistant ovarian carcinoma, defined as recurrence within 6 months after completion of prior platinum-based chemotherapy Patients should have received preferably no more than 5 previous lines of systemic treatment for metastatic disease. \n\n III. Oesophageal carcinoma Patients with oesophageal carcinoma of adenocarcinoma- or squamous cell histology who have received preferably not more than 2 previous lines of systemic treatment for metastatic disease. \n\n IV. Soft tissue sarcoma Patients should preferably have received no more than 2 previous lines of systemic treatment for metastatic disease. \n\n ", - "exclusion_criteria": ": \n\n Serious concomitant non-oncological disease/illness \n\n Active/symptomatic brain metastases \n\n Second malignancy \n\n Pregnancy or breastfeeding \n\n Women or men who are sexually active and unwilling to use a medically acceptable method of contraception. \n\n Treatment with cytotoxic anti-cancer-therapies or investigational drugs within four weeks of the first treatment with the study medication", - "brief_summary": "The primary objective of this trial is to determine the safety and tolerability of BI 853520 monotherapy by defining the maximum tolerated dose (MTD) and recommending the dose for further trials in the development of this compound.~Secondary objectives are~determination of the pharmacokinetic (PK) profile;~exploratory pharmacodynamic analysis; and~collection of preliminary data on anti-tumour efficacy.", - "NCTID": "NCT01335269" - }, - { - "brief_title": "Effects of Oropharyngeal Strengthening on Dysphagia in Patients Post-stroke", - "phase": "", - "drugs": "['Isometric Progressive Resistance Oropharyngeal Therapy', 'Compensatory approaches']", - "drugs_list": [ - "Isometric Progressive Resistance Oropharyngeal Therapy", - "Compensatory approaches" - ], - "diseases": "['Stroke']", - "diseases_list": [ - "Stroke" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n clinical diagnosis of unilateral ischemic strokes by attending physician (according to the National Institute of Health Stroke Scale (NIHSS)) \n\n within 6 months of acute stroke diagnosis \n\n a score of 3 or higher on the Penetration-Aspiration scale OR a score of 2 on the Residue scale at any location (oral cavity, valleculae, or pharynx) that is instrumentally documented by a participating SLP during a standardized videofluoroscopic swallowing study \n\n between the ages of 21 and 95 \n\n ability to perform the strengthening protocol independently or with the assistance of a caregiver \n\n physician approval of medical stability to participate \n\n decision-making capacity to provide informed consent (confirmed through discussion with the subject's primary physician) \n\n phone access \n\n ability to return to the clinic for required follow-up appointments. \n\n ", - "exclusion_criteria": ": \n\n degenerative neuromuscular disease \n\n prior or current diagnosis of bilateral or hemorrhagic stroke \n\n prior surgery to the head and neck region that would affect muscles involved in swallowing \n\n history of radiotherapy or chemotherapy to the head and neck \n\n patient unable to complete the exercise program \n\n taking medications that depress the central nervous system \n\n allergy to barium (used in videofluoroscopic swallowing assessment) \n\n currently pregnant.", - "brief_summary": "The overall goal of this randomized controlled pilot study is to characterize effects of SwallowSTRONG\u00ae Device-Facilitated Isometric Progressive Resistance Oropharyngeal (DF I-PRO) therapy in a dose response framework on swallowing-related outcomes in a group of unilateral ischemic stroke patients. These results will be used to determine adequate sample size in order to support a larger clinical trial focused on the efficacy of this therapy approach for improving swallowing safety. The first aim is to determine differences in swallowing physiology and bolus flow measures a) between a group of unilateral ischemic stroke subjects undergoing SwallowSTRONG\u00ae DF I-PRO therapy and controls and b) between 8 and 12 weeks of treatment. The second aim is to examine changes in level of oral intake and swallowing quality of life in post-stroke patients undergoing DF I-PRO therapy as compared to a control group and as they relate to treatment duration response at 8 weeks and 12 weeks. The third aim is to evaluate effects of DF I-PRO therapy on overall health status reflected by the number of pneumonia diagnoses and overall hospital readmission rates in post-stroke subjects undergoing DF I-PRO therapy compared to controls.", - "NCTID": "NCT02322411" - }, - { - "brief_title": "Satiety Innovation- Study 793. University of Aberdeen", - "phase": "", - "drugs": "['Resistant Starch type 3']", - "drugs_list": [ - "Resistant Starch type 3" - ], - "diseases": "['Overweight and Obesity']", - "diseases_list": [ - "Overweight and Obesity" - ], - "enrollment": "24.0", - "inclusion_criteria": "inclusion criteria: \n\n Males and females \n\n 18-65 years old \n\n Body Mass Index (BMI) 27-35kg/m2 \n\n Overall healthy \n\n Weight Stable (<3 kg change in the past 4 months, before the trial). \n\n ", - "exclusion_criteria": ": \n\n Medical: \n\n Heavy smokers (more than 10 cigarettes/day) or heavy alcohol consumers (more than 4 alcohol units/day for male and more than 3 alcohol units/day for female). \n\n Obesity of endocrine origin. \n\n Chronic metabolic conditions: diabetes, hepatic disease, gout, kidney, thyroid or coagulation disease. \n\n Gastrointestinal disorders: celiac disease, ulcerative colitis, irritable bowel syndrome (IBS), Chron's disease, chronic constipation, diverticulitis, history of gastric bezoar. Suspected strictures, fistulas, or physiological GI obstruction. \n\n Psychiatric disorder: severe depression, bulimia, anorexia, schizophrenia, bipolar disorder. \n\n Gastrointestinal procedure or surgery in the past three months. \n\n Disorders of swallowing, severe dysphagia to food or pills. \n\n Pregnancy \n\n Medication ", - "brief_summary": "The proposed study will address the effect of developed novel food products through processing innovation on motivation to eat, biomarkers of satiety, nutrient bioavailability and gut health using in vivo studies and validating new in vivo approaches.~Specifically in this protocol we will address, in a short human intervention study the effect of a potentially satiating product on appetite, appetite biomarkers, particularly the influence on gut microbiota, tolerance and safety of the products in healthy obese and overweight volunteers in free living conditions.", - "NCTID": "NCT01724411" - }, - { - "brief_title": "Smoking Status and Body Image in Oral Cancer Patients", - "phase": "", - "drugs": "['Questionnaire', 'Interview']", - "drugs_list": [ - "Questionnaire", - "Interview" - ], - "diseases": "['Oral Cavity Cancer']", - "diseases_list": [ - "Oral Cavity Cancer" - ], - "enrollment": "75.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years of age or older \n\n Able to provide written informed consent to participate \n\n Diagnosis of head and neck malignancy involving an oral cavity site without previous treatment \n\n Current treatment plan includes surgical intervention \n\n English speaking \n\n ", - "exclusion_criteria": ": \n\n Previous treatment for malignancy in the head and neck region \n\n Significant preexisting facial disfigurement from a previous trauma or congenital defect \n\n Diagnosis of a serious mental illness involving formal thought disorder (e.g., Schizophrenia) documented in medical record.", - "brief_summary": "Primary Objectives:~To characterize smoking behaviors and body image in patients with oral cavity cancer prior to and following surgical procedures.~To examine the relationship between smoking status and body image in this sample of head and neck cancer patients.~To examine the influence of smoking status and body image on quality of life outcomes.", - "NCTID": "NCT00412490" - }, - { - "brief_title": "Comparative Effectiveness of Adding Weight Control to Smoking Cessation Quitlines", - "phase": "", - "drugs": "['Weight gain prevention and smoking cessation', 'Smoking cessation']", - "drugs_list": [ - "Weight gain prevention and smoking cessation", - "Smoking cessation" - ], - "diseases": "['Cigarette Smoking', 'Overweight', 'Obesity']", - "diseases_list": [ - "Cigarette Smoking", - "Overweight", - "Obesity" - ], - "enrollment": "2540.0", - "inclusion_criteria": "inclusion criteria: \n\n Participating Client \n\n Not Re-Enrolling \n\n USA Resident \n\n Wants to quit in the next 30 days \n\n Use Cigarettes (other types ok, but must use cigarettes) \n\n 18 years or older \n\n Speak English \n\n Provide Phone \n\n Provide Email Address \n\n Use 10 cigarettes per day or more \n\n BMI of 18.5 or above \n\n No history of anorexia or bulimia \n\n ", - "exclusion_criteria": ": \n\n Pregnant or Planning Pregnancy within 3 months \n\n Diabetic \n\n Previous weight loss surgery or planning weight loss surgery in next 12 months", - "brief_summary": "This randomized controlled trial compares the effectiveness for both smoking cessation and weight control of two alternative combined interventions offered via telephone quitline, as compared to standard of care quitline treatment addressing cessation alone. The interventions to be compared are cessation treatment alone versus cessation treatment combined with weight control treatment added either simultaneously or sequentially.", - "NCTID": "NCT01867983" - }, - { - "brief_title": "Tumor Markers in Lung Cancer: DCAMLK-1LK-1", - "phase": "", - "drugs": "['Measure DCAM levels in blood', 'DCAM levels in blood']", - "drugs_list": [ - "Measure DCAM levels in blood", - "DCAM levels in blood" - ], - "diseases": "['Lung Cancer', 'Smoking']", - "diseases_list": [ - "Lung Cancer", - "Smoking" - ], - "enrollment": "49.0", - "inclusion_criteria": "inclusion criteria: \n\n >45 years of age \n\n ", - "exclusion_criteria": ": \n\n Unable to provide informed consent", - "brief_summary": "DCAMLK1 is a Ca2+ - ca/modulin (CaM) - dependent protein kinase that is a marker of stem cells in colonic crypts. Mutations within the stem cell population are thought to be responsible for the development of most colorectal carcinomas and studies have shown that DCAMLK1 is highly expressed in these tumors. Since the lung is an embryological development of the foregut, the investigators speculate that DCAMLK1 will also be upregulated in lung cancers.~The aim of this pilot study is to measure DCAMLK1 levels in the blood of patients with suspected malignant and benign lung diseases, and to correlate DCAMKL1 levels with smoking status.", - "NCTID": "NCT01578018" - }, - { - "brief_title": "Effect of Varenicline on Reactivity to Smoking and Drinking Cues", - "phase": "", - "drugs": "['Varenicline', 'Placebo']", - "drugs_list": [ - "Varenicline", - "Placebo" - ], - "diseases": "['Tobacco Dependence', 'Alcohol Dependence']", - "diseases_list": [ - "Tobacco Dependence", - "Alcohol Dependence" - ], - "enrollment": "48.0", - "inclusion_criteria": "inclusion criteria: Heavy Smokers/Heavy Drinkers \n\n Treatment seeking smokers \n\n Age 18 to 65 years \n\n Smoke \u2265 10 cigarettes per day \n\n Fagerstrom Test of Nicotine Dependence score > 3 \n\n Alcohol Use Disorders Identification Test (AUDIT) > 8 \n\n Drink > 25 drinks per week for males or > 20 drinks per week for females \n\n Able to provide written informed consent \n\n inclusion criteria (Heavy Smokers/Social Drinkers): \n\n Treatment seeking smokers \n\n Age 18 to 65 years \n\n Smoke \u2265 10 cigarettes per day \n\n Fagerstrom Test of Nicotine Dependence score > 3 \n\n Alcohol Use Disorders Identification Test(AUDIT) < 8 \n\n Drink < 14 drinks per week for males or < 9 drinks per week for females \n\n Able to provide written informed consent \n\n ", - "exclusion_criteria": " (Heavy Smokers/Heavy Drinkers): \n\n Any medical condition requiring immediate investigation or treatment \n\n Beck Depression Inventory score >16 \n\n Insulin-dependent diabetes \n\n Drink > 70 standard alcoholic drinks per week for males or drink > 52 standard alcoholic drinks per week for females \n\n Pregnancy or lactation \n\n Current DSM-IV Axis 1 psychiatric disorder \n\n Regular use of any therapeutic or recreational psychoactive drug use during the last three months or other substance use disorder, with the exception of tobacco and alcohol. \n\n ", - "brief_summary": "Alcohol and nicotine dependence are often co-morbid, with 85% of alcoholics also smoking. However, very little research has been conducted into the nature of this co-occurrence. Thus, the main aim of this study is to assess differences in alcohol and tobacco consumption and cue-induced craving in treatment-seeking smokers after two weeks treatment of varenicline.~Hypotheses~Two weeks of varenicline treatment will significantly decrease cue-induced tobacco craving compared to placebo (Due to the actions of varenicline on alpha-4-beta-2 receptors and its downstream effect on dopamine release).~Varenicline will decrease cue-induced alcohol craving compared to placebo.~The impact of Varenicline on cue-induced alcohol craving will be greater in heavy drinkers compared to social drinkers.", - "NCTID": "NCT00873535" - }, - { - "brief_title": "The Use of Functional Confections in Promoting Oral Health", - "phase": "Phase 1", - "drugs": "['Strawberry gummy', 'Placebo control gummy']", - "drugs_list": [ - "Strawberry gummy", - "Placebo control gummy" - ], - "diseases": "['Oral Health', 'Oral Cancer', 'Gum Disease']", - "diseases_list": [ - "Oral Health", - "Oral Cancer", - "Gum Disease" - ], - "enrollment": "36.0", - "inclusion_criteria": "inclusion criteria: \n\n Submit to a 24 hour urine cotinine test which will be used to determine smoking status. \n\n Meet one of the following smoking criteria \n\n Non-smoker \n\n Does not currently smoke or has no history of smoking or using tobacco related products (cigarettes, cigars, pipe, snuff, or chewing tobacco) or smoking any non-tobacco related products and urine cotinine (less than 100 ng/mL \n\n Does not currently smoke but has quit smoking for more than 10 years and smoked less than 1 pack/day of cigarettes when they were actively smoking and has a urine cotinine (less than 100 ng/mL). \n\n Smoker \n\n Smokes habitually at least 10 cigarettes/day and a urine cotinine level of >1000 ng/mL. Cigar and pipe smokers who smoke at least 10 grams of tobacco daily are also eligible. \n\n Agree to consume a standardized vitamin and mineral supplement and avoid other nutritional, dietary, or alternative medications/supplements for the duration of the study. \n\n No history of malabsorptive, gastrointestinal or other metabolic disorders requiring special diet recommendations. \n\n Body mass index (BMI) between 20 and 35 kg/m2 \n\n Abstain from purple and red colored foods and beverages which contain significant anthocyanins and polyphenols \n\n Abstain from the use of ANY mouth washes (commercial or home remedies)during 6 week study period \n\n ", - "exclusion_criteria": " \n\n Have a known allergy to strawberries, corn, and wheat products or those who have never consumed any of these products. \n\n Have active metabolic or digestive illnesses such as malabsorptive disorders (Crohn's, ileus, IBS), renal insufficiency, hepatic insufficiency, hyper- or hypothyroidism, cachexia, morbid obesity, or short bowel syndrome. \n\n Have a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, ACTH, growth hormone, insulin) or other endocrine disorders requiring hormone administration. \n\n Have significant loss of gastrointestinal organs due to surgery, except for appendix. \n\n Have altered immunity such as chronic inflammatory disease, autoimmune disorders, cancer, anemia, hemophilia, and blood dyscrasias. \n\n Heavy alcohol consumers defined as >15 glasses/week (one glass = 1.5 oz. liquor, 5 oz. wine, or 12 oz. beer). \n\n Antibiotic use in the last 6 months or on medications that will accelerate or decrease bowel motility. \n\n Are receiving or in need of dental treatment during the study period. \n\n Have noticeable open lesions, sores that have not healed for more than 3 months, have had any active oral lesions or maladies within the last month, or have a history of leukoplakia, tumors of the buccal cavity, throat, and lips. \n\n Have difficulty swallowing (dysphagia), pain with swallowing (odynophagia), salivary gland dysfunction, or xerostomia (dry mouth). \n\n A non-smoker who is currently or has a history (less than 10 years of smoking abstinence) of either tobacco or non-tobacco related smoking. \n\n Women, who are planning to conceive in the next 6 months, suspect they are pregnant, pregnant, or nursing. \n\n Are taking medications that inhibit clotting (warfarin sodium) or using prescribed oral rinses (Peridex).", - "brief_summary": "In areas of the world where populations are undernourished poor oral health is prevalent. Diets rich in fruit and vegetables are thought to have many health benefits including reducing the risk of oral cancer or gum disease. In particular fruits such as strawberries contain many different compounds which may be responsible for these proposed health benefits.~From this study, the researchers hope to gain information about how the tissues in the mouth absorb strawberry gummies in a population of habitually smoking and never smoking men and women. The researchers will measure inflammation hormones in your saliva and urine and the genes in your mouth and blood. Two different strawberry gummies will be tested in this study. The strawberry gummies were developed at OSU in the Department of Food Science and Technology. One type of strawberry gummy will contain freeze-dried whole strawberries while the other type will have no fruit. In total the eight pieces of strawberry gummies that you will consume in one day will be at most equal to 1 cup of whole strawberries. The research team believes the two strawberry gummies may be digested and absorbed differently and that components in the strawberry gummies may be helpful for oral health.", - "NCTID": "NCT01514552" - }, - { - "brief_title": "Biomarkers in the Nose, Throat, and Lung Tissue of Smokers and Non-Smokers", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Lung Cancer', 'Precancerous Condition']", - "diseases_list": [ - "Lung Cancer", - "Precancerous Condition" - ], - "enrollment": "112.0", - "inclusion_criteria": "inclusion criteria: \n\n - Adults > 45 years of age, to be age matched with a previously enrolled cohort of current and ex-smokers with airflow obstruction and moderate atypia on sputum cytology, to be included in the following groups. \n\n - Non-smoking (less than 100 cigarettes per lifetime) controls >50 years of age, to be age matched with a previously enrolled cohort with airflow obstruction (FEV1 < 75% predicted and FEV1/FVC < 75%) and moderate atypia on sputum cytology. \n\n - Current smokers with > 30 pack years, no airflow obstruction (FEV1 > 90% predicted) or lung cancer, >50 years of age, to be age matched with a previously enrolled cohort with airflow obstruction and moderate atypia on sputum cytology . \n\n - No prior history of a head and neck or bronchogenic carcinoma. \n\n - Patients must be fully informed of the investigational nature of this study and must sign an informed consent in accordance with institutional and FDA guidelines. \n\n ", - "exclusion_criteria": ": \n\n - Clinically apparent bleeding diathesis. \n\n - Cardiac dysrhythmia that is potentially life-threatening, such as ventricular tachycardia, multifocal premature ventricular contractions or supraventricular tachycardias with a rapid ventricular response. Well-controlled atrial fibrillation or rare (< 2/minute) premature ventricular contractions are not exclusionary. \n\n - Hypoxemia (less than 90% saturation with supplemental oxygen) during bronchoscopy. \n\n - Evidence of clinically active coronary artery disease, including myocardial infarction within 6 weeks, chest pain, or poorly controlled congestive heart failure, or any other serious medical condition which would preclude a patient from undergoing a bronchoscopy. \n\n - Acute bronchitis or pneumonia within 8 weeks. \n\n - Inability to give informed consent. \n\n - Current smokers with no airflow obstruction may not have a history of coughing more than two times /week.", - "brief_summary": "RATIONALE: Studying samples of tissue from smokers and non-smokers in the laboratory may help doctors identify and learn more about biomarkers related to cancer.~PURPOSE: This phase II study is looking at biomarkers in the nose, throat, and lung tissue of smokers and non-smokers.", - "NCTID": "NCT00897364" - }, - { - "brief_title": "Theory-Based Interventions for Smoking and Obesity (Challenge) Trial", - "phase": "Phase 3", - "drugs": "['smoking cessation program', 'weight control program']", - "drugs_list": [ - "smoking cessation program", - "weight control program" - ], - "diseases": "['Smoking', 'Obesity']", - "diseases_list": [ - "Smoking", - "Obesity" - ], - "enrollment": "1778.0", - "inclusion_criteria": "Eligibility criteria for the smoking cessation studies were: between 18 and 60 years old, a minimum 2-year history of smoking, a current level of smoking > 10 cigarettes per day, and agreement to participate in the study. \n\n Eligibility requirements for the weight loss studies were: between 18 and 60 years old, body mass index (weight/height2) > 27.0, 20 percent or more above desirable weight according to medical standards, and consent to participate. \n\n Smokers and overweight persons were excluded if currently being treated by a physician for a serious physical or psychological disorder (e.g., heart disease, cancer, depression). Women were excluded if currently pregnant, pregnant in the last 6 months, or intending to become pregnant in the next 18 months. People who were overweight and who also smoked were considered eligible for participation in either weight loss or smoking cessation programs. However, they received treatment only for the particular behavior problem targeted by the study they chose to participate in.", - "exclusion_criteria": "", - "brief_summary": "The purpose of this study is to examine a new theory for understanding the processes that govern behavior change by observing how people's beliefs and feelings about smoking cessation or weight loss change as they participate in smoking cessation or weight control programs. This study also seeks to improve the ability of treatment programs to help people maintain changes in their behavior.", - "NCTID": "NCT00040287" - }, - { - "brief_title": "Vanguard Study for Head and Neck Cancer or Non-Small Cell Lung Cancer (NSCLC) Patients", - "phase": "", - "drugs": "['Assessments']", - "drugs_list": [ - "Assessments" - ], - "diseases": "['Head and Neck Cancer', 'Lung Cancer']", - "diseases_list": [ - "Head and Neck Cancer", - "Lung Cancer" - ], - "enrollment": "54.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with either: a) histologically proven stage I, II, IIIa NSCLC who have undergone a complete surgical resection of the primary tumor OR b) stage I or II HNSCC who have undergone definitive local treatment (surgery or radiation therapy). \n\n HNSCC patients:Definitive local treatment = 18 years \n\n Performance status of 0- 2 (Zubrod) \n\n Patients must have no contraindications for undergoing bronchoscopy. \n\n Patients must have no active pulmonary infections. \n\n Participants must have the following blood levels: total granulocyte count >1500; platelet count > 100,000; total bilirubin < = 1.5 mg. %; and creatinine < = 1.5 mg %. \n\n Participants must complete the pretreatment evaluation and must consent to bronchoscopy and to endobronchial biopsy for biomarker studies. \n\n All subjects who agree to participate will be given a written and verbal explanation of the study requirements and a consent form that must be signed prior to registration. Subjects will be informed that (a) they must be willing to take biopsies through bronchoscopy and give blood samples at the specified times, (b) they must schedule and keep the specified follow-up visits with their physicians and the study clinics, and (c) side effects and health risks may occur, as described in the informed consent form. \n\n Smoking history of at least 10 pack years. May be current or former smoker. \n\n Subject must be considered legally capable of providing his or her own consent for participation in this study. \n\n HNSCC patients only: Must have no contraindications for undergoing laryngoscopy. \n\n ", - "exclusion_criteria": ": \n\n History of radiation therapy to the chest. For those patients with head and neck cancer who received radiation, no more than 10% of the lung volume (apices) may be included. \n\n History of systemic chemotherapy. Exception: NSCLC patients may have had up to 4 cycles of platinum-based doublet therapy. \n\n Pregnant or breast-feeding (a negative pregnancy test within 72 hours of enrollment for women with child-bearing potential is required). \n\n Participants with active pulmonary infections or recent history of pulmonary infection (within one month). \n\n Participants with acute intercurrent illness. \n\n Participants requiring chronic ongoing treatment with NSAIDs except aspirin. \n\n Participants with history of stroke, uncontrolled hypertension, and/or uncontrolled angina pectoris. \n\n Patients may not take high dose antioxidants (vitamins E or C) during the study period. High dose will be determined by the study investigators. \n\n Patients may not take high dose synthetic or natural Vitamin A derivatives (> 10,000 IU per day). High dose is defined as anything greater than a once-daily multivitamin. Any additional supplementation will be evaluated at the discretion of the treating physician. \n\n History of biologic therapy.", - "brief_summary": "The goal of this research study is to look at how long individuals who have been treated for early stage NSCLC or HNSCC live without developing lung cancer. Another goal is to develop tools to help predict the likelihood of lung cancer occurrence in this population. This will be done by studying characteristics of tissue and bodily fluids (including blood).~Objectives:~To assess the smoking-related disease-free survival in patients who are current or former smokers with a prior definitively-treated stage I/II lung or head and neck cancer.~To develop a risk model to help predict the likelihood of lung cancer development both imaging and biomarker based in this high-risk population.", - "NCTID": "NCT00352391" - }, - { - "brief_title": "Treating Adults at Risk for Weight Gain With Interactive Technology", - "phase": "Phase 3", - "drugs": "['Smoking Cessation', 'Smoking Cessation plus Weight Loss']", - "drugs_list": [ - "Smoking Cessation", - "Smoking Cessation plus Weight Loss" - ], - "diseases": "['Body Weight', 'Smoking']", - "diseases_list": [ - "Body Weight", - "Smoking" - ], - "enrollment": "330.0", - "inclusion_criteria": "inclusion criteria: \n\n The selection criteria for the clinical trial are designed to include a wide range of participants such that the study sample will be representative of the broader U.S. population of the Memphis metropolitan area. Those who might be at risk of adverse outcomes from the study interventions will be excluded (see ", - "exclusion_criteria": "). All participants will give voluntary consent at the screening visit by signing an informed consent statement which has been approved by the Institutional Review Board (IRB). We will encourage the participation of women and minorities. The study will be open to all persons of any race or gender who are: \n\n *18 to 35 years old \n\n BMI > 22 kg / m2 \n\n Self report smoking > 10 cigarettes each day \n\n Have access to a telephone and the internet \n\n Demonstrate ability to access a specific web site \n\n Demonstrate ability to receive and respond to email \n\n Willing to accept random assignment \n\n *Intending to be available for a 24 month intervention \n\n *At risk for weight gain (e.g. plan to quit smoking) \n\n ", - "brief_summary": "Obesity represents a chronic disease associated with significant cardiovascular disease (CVD) morbidity and mortality. Weight gain in young adults adversely impacts the development of CVD risk factors. Further, there is a clear relationship between weight loss in obese persons and reduction in these CVD risk factors. Unfortunately, young adults are at high risk for weight gain. Although the scientific literature contains a number of reports regarding successful weight loss efficacy studies, young adults are typically underrepresented.~Cigarette smoking is the leading preventable cause of morbidity and mortality, but quitting smoking frequently results in significant weight gain. Proactive tobacco quit lines using behavioral smoking cessation interventions combined with nicotine replacement therapy (NRT) have been shown to help persons quit smoking. However, concerns about post-cessation weight gain have been reported as a significant barrier to quitting for many smokers particularly young adults.~If an efficacious behavioral weight loss program could be combined with an efficacious behavioral smoking cessation program that prevented or significantly attenuated post-cessation weight gain, then a large public health benefit may result. Such a combined weight loss/ weight gain prevention / smoking cessation program that used targeted intervention strategies to young adults, removed barriers to participation, and utilize interactive technology should be appealing to this age group. To date such a combined program has not been tested in young adult cigarette smokers. Therefore, the objective of this clinical trial is to develop and test a behavioral weight loss / weight gain prevention intervention delivered through interactive technology that can be used in conjunction with an efficacious tobacco quit line. A total of 330 participants will be necessary to adequately address the following specific aims.", - "NCTID": "NCT01199185" - }, - { - "brief_title": "Cigarette Smoking and Oral Microbiota", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Microbiota', 'Lung Cancer', 'Oral Cancer']", - "diseases_list": [ - "Microbiota", - "Lung Cancer", - "Oral Cancer" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria \n\n This study will recruit a convenience sample of 50 volunteers (25 current smokers with at least 5 years of smoking history, 25 never smokers). Current smokers are defined as individuals who have smoked more than 100 cigarettes in their lifetime and have smoked 5 or more cigarettes in the last 24 hours. Recent use of other tobacco products (pipe, cigar, snuff, cigarillos, and chewing tobacco) is an overall exclusion, but use in the remote past (> 6 month ago) is acceptable in smokers. Never smokers are defined as individuals who have never smoked cigarettes nor used any other tobacco products including pipe, cigar, snuff, cigarillos, or chewing tobacco. \n\n The ethnic mix of the clinic is roughly 50% Caucasians and 50% African- Americans with a small number of unspecified or other racial groups. The median age is about 50 and the gender mix consists of an equal number of men and women. We therefore will select smokers and frequency match to non-smokers based on ethnicity (White, African-American), gender (male, female), and age (above or below the median, estimated to be 50). \n\n ", - "exclusion_criteria": " \n\n We will exclude pregnant women and other racial groups because they may represent very small numbers and thus be difficult to match. Hormonal changes associated with pregnancy and unique cultural habits associated with specific ethnic groups could be associated with highly unique or variable microbiome patterns, and therefore reduce the power to detect differences associated with smoking which is our primary goal. We will also exclude subjects with antibiotic usage in the last three months and subjects with previous diagnosed major periodontal disease or cancer because they might be potential confounders.", - "brief_summary": "Background:~- Normal bacteria and other tiny organisms (the microbiota) live in the mouth and nose. They contribute to human health in many ways, including digesting food and balancing hormones. Testing samples from the mouth can show how microbiotas are related to health and disease. However, the microbiota in a person's mouth differs depending on the methods of collection and the part of the mouth that is tested. Understanding what can change the microbiota (including mouth sites, and what a person eats or smokes) will give more information on how to study oral microbiota and smoking-related cancers and other diseases.~Objectives:~To see how smoking affects the microbiotas in mouth and nose.~To determine which collection method for mouth specimens should be used for studying microbiota.~Eligibility:~Individuals at least 18 years of age who have been using tobacco products regularly for at least 5 years.~Individuals at least 18 years of age who have never smoked.~Design:~Participants will be screened with a physical exam and medical history.~Participants will have a dental exam. They will provide a saliva sample. The dentist will take swabs from the inside of the mouth, including the tongue, tonsils, gums, and teeth. The inside of the nose will also be swabbed.~Participants will also fill out a questionnaire. It will ask about their history of smoking and consumption of alcohol, tea, and coffee. It will also ask about current medications, including antibiotics.", - "NCTID": "NCT01862809" - }, - { - "brief_title": "Pancreatic Insufficiency Secondary to Tobacco Exposure", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pancreatic Insufficiency']", - "diseases_list": [ - "Pancreatic Insufficiency" - ], - "enrollment": "202.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female at least 30 years of age \n\n Able to read, understand, and sign informed consent \n\n Patients with a negligible smoking history (defined as no smoking for the past 7 years, and a total smoking history \u2264 5 pack-years) OR patients with AT LEAST a 20 pack-year smoking history \n\n ", - "exclusion_criteria": ": \n\n Patients with a prior diagnosis of pancreatic insufficiency \n\n Patients who have a current or remote history of acute or chronic pancreatitis or any other primary pancreatic disease or malignancy \n\n Patients who have had pancreatic surgery \n\n Patients with a diagnosis of small bowel malabsorption or Celiac disease \n\n Patients with any other significant systemic disease that is deemed by the investigator as possibly interfering with the conduct or interpretation of the study", - "brief_summary": "Pancreatic insufficiency is a condition in which there is a decrease in the production and release of enzymes made in the pancreas, which causes nutrient malabsorption. There are many chronic diseases that can lead to pancreatic insufficiency. In the early stages of this disease, a patient may not experience any symptoms, and the prevalence of pancreatic insufficiency may be underestimated. Smoking has long been recognized as a cause of disease in many organs in the body. Cigarette smoke causes inflammation and damages tissue, including the pancreas. Studies have shown that smoking is an independent risk factor for pancreatic cancer and chronic pancreatitis. It has also been shown that the more a person smokes, the worse his disease will be. Additionally, there are studies that show that smokers have nutritional deficiencies. There are observational and retrospective studies that suggest that pancreatic insufficiency may also be caused by smoking. However, this has not been established, and the relationship has not been examined in a controlled manner. This study examines the relationship between smoking and pancreatic insufficiency in patients who do not have other pancreatic diseases.", - "NCTID": "NCT01988350" - }, - { - "brief_title": "A Randomized Clinical Trial Assessing Smoking Cessation Interventions In Dental Clinic Smokers", - "phase": "", - "drugs": "['Standard Care only', 'Dental Hygienist provided counseling + Brief Questionnaire', 'Dental Hygienist provided counseling with personalized risk communication + Brief Questionnaire']", - "drugs_list": [ - "Standard Care only", - "Dental Hygienist provided counseling + Brief Questionnaire", - "Dental Hygienist provided counseling with personalized risk communication + Brief Questionnaire" - ], - "diseases": "['Smoking Cessation']", - "diseases_list": [ - "Smoking Cessation" - ], - "enrollment": "1072.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient seeking routine dental care at NYU College of Dentistry and meets medical clearance for routine care \n\n Active smokers (active smoking as self-reported regular use of at least 10 cigarettes per day) \n\n Able to provide a telephone number or collateral contact information where they can be reached over the subsequent 12 months \n\n Fluent in English or Spanish \n\n ", - "exclusion_criteria": ": \n\n History of mouth or throat cancer", - "brief_summary": "The goal of this study is to see if giving patients information about how smoking affects oral health will help them quit smoking. What we learn from this study will help researchers find new ways to help smokers.", - "NCTID": "NCT00591175" - }, - { - "brief_title": "K-RAS Oncogene Mutation in Patients With Advanced Non-Small Cell Lung Cancer Associated With Exposure to Wood Smoke and Tobacco Smoking: Therapeutic Implications", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Non-Small Cell Lung Cancer']", - "diseases_list": [ - "Non-Small Cell Lung Cancer" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients diagnosed with advanced NSCLC stage IIIB/IV who have not received previous chemotherapy \n\n Radiotherapy or both and who have tumor tissue embedded in paraffin blocks or formalin-fixed \n\n These patients must sign an informed consent letter. \n\n ", - "exclusion_criteria": ": \n\n Patients who refuse to participate in the study or those who decide to withdraw from it. \n\n Patients without tumor tissue or with a poor quality sample.", - "brief_summary": "Summary:~Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related death in the world. This neoplasia has a poor survival prognosis due to the low effectiveness of existing treatments. The low effectiveness is associated with the development of an intrinsic and acquired resistance of tumors, which clinically shows through early progression and transitory responses. Tobacco smoking is the major risk factor for NSCLC; however, wood smoke has been described as a strong carcinogen and a relevant risk factor for the development of NSCLC. Current data indicates that lung tumors associated with tobacco smoking and wood smoke show different clinical characteristics, which suggests that they might also have different genetic alterations, which are a consequence of tumor etiology. The description of the frequency and the type of mutations associated with different etiologies of NSCLC could represent the starting point for benefiting each patient according to their specific characteristics. One of the most researched signaling pathways related to cancer cell proliferation is the one activated by the K-RAS oncogene. Active K-RAS mutations have been detected in different types of neoplasia and more than 90% of these mutations occur at codon 12 of the oncogene. These mutations seem to be an independent risk factor for the prognosis of malignant tumors and they are associated with the lack of response to erlotinib, which is a tyrosine-kinase inhibitor. The investigators' research team has recently reported that wood smoke is an independent factor for survival and response to the erlotinib treatment, which suggests that this carcinogen could have a different frequency and pattern of mutations in the K-RAS oncogene, compared to what has been reported in smoking patients. Determining the tumor mutations within the K-RAS oncogene can help improve the response prognosis of patients with advanced NSCLC who have a background of exposure to different factors associated with the appearance of this neoplasia, such as wood smoke exposure or tobacco smoking. Therefore, the objective of this research is to determine the frequency and the type of mutations at codon 12 of the K-RAS oncogene in patients with NSCLC who have a background of exposure to tobacco smoking or wood smoke.", - "NCTID": "NCT01023828" - }, - { - "brief_title": "Financial Incentives for Maintenance of Weight Loss", - "phase": "", - "drugs": "['Financial incentive']", - "drugs_list": [ - "Financial incentive" - ], - "diseases": "['Obesity']", - "diseases_list": [ - "Obesity" - ], - "enrollment": "191.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults age 30-80 \n\n BMI between 30 and 45 prior to starting Weight Watchers \n\n Have a documented weight loss of at least 5kg in the past 4-6 months before enrolling \n\n Stable health \n\n ", - "exclusion_criteria": ": \n\n Substance abuse \n\n Bulimia nervosa or related behaviors \n\n Pregnancy or breast feeding \n\n Medical contraindications to counseling about diet, physical activity, or weight reduction \n\n Unstable mental illness \n\n Screen positive for pathological gambling on the basis of the 10 item DSM-IV criteria (excluded if meets 5 or more criteria) \n\n Individuals unable to read consent forms or fill out surveys in English", - "brief_summary": "This study aims to evaluate the effectiveness of financial incentives in improving and maintaining weight loss.", - "NCTID": "NCT01900392" - }, - { - "brief_title": "Efficacy and Safety of Varenicline Among HIV-infected Patients", - "phase": "Phase 3", - "drugs": "['Varenicline', 'Placebo']", - "drugs_list": [ - "Varenicline", - "Placebo" - ], - "diseases": "['HIV Infections', 'Tobacco Dependence']", - "diseases_list": [ - "HIV Infections", - "Tobacco Dependence" - ], - "enrollment": "248.0", - "inclusion_criteria": "inclusion criteria: \n\n HIV-infected patients \n\n adults \n\n regular smokers (at least 10 cigarettes a day during the last year) \n\n motivated to stop smoking \n\n followed in one of the participating clinical ward, \n\n signed written inform consent \n\n ", - "exclusion_criteria": ": \n\n current co-dependency to another psychoactive substance \n\n ongoing depressive episode \n\n history of suicidal attempt \n\n ongoing treatment by interferon \n\n treatment by efavirenz for less than three months or not tolerated \n\n previous use of varenicline \n\n ongoing treatment by bupropion-SR or nicotinic substitute \n\n ongoing pregnancy \n\n ongoing breastfeeding \n\n hypersensitivity to varenicline or to one of its excipients \n\n drivers, air traffic controller", - "brief_summary": "Cigarette smoking is a major cause of illness among HIV-infected patients (non-AIDS defining malignancies (especially lung cancer), non-AIDS bacterial infections and cardio-vascular diseases). Approximately 50% of HIV-infected patients are regular tobacco smokers. Tobacco smoking cessation has well known benefits on mortality and morbidity in the general population where tobacco cessation assistance programs are increasingly implemented. However, smoking cessation interventions have never been evaluated among HIV-infected patients. This trial aims at evaluating the efficacy and safety of varenicline for smoking cessation compared with placebo.", - "NCTID": "NCT00918307" - }, - { - "brief_title": "Study to Evaluate the Natural History of Head and Neck Cancer Precursors in Taiwan", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Head and Neck Neoplasms']", - "diseases_list": [ - "Head and Neck Neoplasms" - ], - "enrollment": "3576.0", - "inclusion_criteria": "inclusion criteria \n\n We plan to recruit all patients (controls, precursors, and invasive cancers) at the aforementioned two hospitals. Doctors at these hospitals conduct routine visual and tactile examination as part of Taiwan s national oral cancer screening program. For this screening program, all individuals aged 21 years or older who chew betel-quid or smoke are screened through visual inspection for the presence of precursor lesions or cancer. \n\n ", - "exclusion_criteria": " \n\n Participants younger than 21 years and individuals with a history of head and neck cancer will be excluded from the study.", - "brief_summary": "Background:~- Cancer of the mouth and throat is one of the most common cancers in Taiwan. This cancer develops over several years, beginning as white or red patches in the mouth or throat that become growths. It can also cause a condition that leads to rigidity of the cheeks. The growths can be identified when a doctor looks into a person s mouth. It is currently not clear why some people with abnormal growths progress to cancer while others do not. Researchers want to better understand why some patients with early abnormal growths get late abnormal growths. They also want to understand why some people get abnormal growths again, even after they receive treatment.~Objectives:~- To understand why some people with precancerous lesions in their mouth develop cancer while others do not.~Eligibility:~- Adults 21 years and older, some with abnormal growths in the mouth, some without any, and some with head and neck cancer.~Design:~Participants will visit a hospital in Taiwan 2 times.~At the first visit, participants will answer questions about their health, lifestyle, and family medical history. A doctor will examine the participant s mouth and take a small piece of any growth they see. They will do this with a brush. They will also photograph the participant s mouth. Participants will also give blood and saliva samples, plus a small sample of a mouth rinse.~Participants who are diagnosed with a late abnormal growth that is not cancer will return for a second visit. They will answer the same questions and undergo the same procedures as at the first study.", - "NCTID": "NCT02017288" - }, - { - "brief_title": "Impact of Size of Gastric Sleeve on the Weight Loss. Correlation With Gastric Function and Endocrine-metabolic Changes.", - "phase": "", - "drugs": "['Bougie Size 33 Fr', 'Bougie Size 42 Fr', 'Distance pylorus 2 cm', 'Distance pylorus 5 cm']", - "drugs_list": [ - "Bougie Size 33 Fr", - "Bougie Size 42 Fr", - "Distance pylorus 2 cm", - "Distance pylorus 5 cm" - ], - "diseases": "['Obesity, Morbid']", - "diseases_list": [ - "Obesity", - "Morbid" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Age more than 18 years and less than 65 years \n\n BMI more than 40 kg/m2 or more than 35 kg/m2 with comorbidities likely to improve after weight loss. \n\n Morbid obesity established at least five years. \n\n Continued failures to adequately supervised conservative treatments \n\n Absence of endocrine disorders that are due to morbid obesity. \n\n Psychological stability: \n\n No alcohol or drug abuse. \n\n Absence of major psychiatric disorders (schizophrenia, psychosis), mental retardation, eating disorders (bulimia nervosa). \n\n Ability to understand the mechanisms to lose weight with surgery and understand that not always achieved good results. \n\n Understand that the goal of surgery is to achieve the ideal weight. \n\n Commitment for Adherence to surveillance guidelines after surgery \n\n Informed consent after receiving all the necessary information (oral and written). \n\n Women of childbearing age should avoid pregnancy for at least the first year after surgery \n\n ", - "exclusion_criteria": ": \n\n No acceptance \n\n Age less than 18 years or more than 65 years \n\n Previous bariatric surgery \n\n Previous gastric surgery \n\n Inflammatory bowel disease", - "brief_summary": "Morbid Obesity (MO) is considered the most important epidemic in the developed world in the twenty-first century. After initial assessment of morbidly obese patients and the exclusion of potentially correctable causes, management involves a combination of dietary changes, cognitive therapy, physical activity, psychological support and pharmacological treatment. However, any combination of these factors has proven long-term effectiveness in achieving significant and sustained reduction of excess weight. Currently, surgery is the only treatment capable of achieving this goal, interacting also with significant improvement in quality of life and overall long-term mortality.~In recent years, several authors have reported excellent short-term results with performing sleeve gastrectomy, but whether some aspects regarding the variability of gastric tubulization design could influence the results obtained in relation to weight loss and functional changes and gastric hormones.~The main objective of this study is to assess the size of the gastric tubulization (based probe calibration and the distance from the pylorus to which initiate gastric section) that can provide a better clinical outcome (such as excess weight loss) in patients undergoing surgery for morbid obesity. Secondary objectives were to assess the morphological changes, physiological and hormonal obtained according to the size of the gastric tubulization and its effect on weight loss patients.", - "NCTID": "NCT02144545" - }, - { - "brief_title": "Brain Regulation of Appetite in Twins", - "phase": "", - "drugs": "['Functional Magnetic Resonance Imaging', 'Dual Energy X-ray absorptiometry', 'Questionnaires', 'Mood and Appetite Ratings', 'Test Meals', 'Computer Tests', 'Intravenous Catheter (IV) placement']", - "drugs_list": [ - "Functional Magnetic Resonance Imaging", - "Dual Energy X-ray absorptiometry", - "Questionnaires", - "Mood and Appetite Ratings", - "Test Meals", - "Computer Tests", - "Intravenous Catheter (IV) placement" - ], - "diseases": "['Obesity', 'Appetite']", - "diseases_list": [ - "Obesity", - "Appetite" - ], - "enrollment": "122.0", - "inclusion_criteria": "inclusion criteria: \n\n Ability and willingness to come with their twin to the University of Washington (Seattle) \n\n Additional Criteria for Aim 1 random sample only: Member of randomly selected MZ pair or \n\n Additional criteria for Aim 2 random sample only: One member of MZ or same-sex DZ pair with BMI of at least 30 kg/m^2 \n\n Additional criteria for Aim 3 sample only: Member of randomly selected MZ pair, and not BMI discordant \u2265 5 kg/m^2 \n\n ", - "exclusion_criteria": ": \n\n History of weight loss surgery or active participation in weight loss program \n\n Major medical problem (e.g., diabetes, cancer) \n\n Current use of weight loss medications or other medications known to alter appetite \n\n Pregnancy or menopause \n\n MRI contraindication (i.e., implanted metal, claustrophobia) \n\n Lifetime eating disorder \n\n Current smoking \n\n Current heavy alcohol use (\u22652 drinks per day for females and \u2265 3 drinks per day for males) \n\n Self-reported weight >330 pounds at time of phone screening. MRI cannot accommodate all shapes or weights. Inability to have MRI does not exclude subject from participating in other study procedures. \n\n BMI < 18.5 or > 45 kg/m^2 \n\n Allergies to study foods or inability to taste \n\n Twins were raised apart \n\n Co-twin not eligible or not willing to participate", - "brief_summary": "Scientists are examining the genetic and environmental influences on appetite and weight gain. The main purpose of this study is to look at how genetic and environmental factors may influence how the brain regulates appetite and food intake. Understanding how the brain regulates appetite and food intake may eventually lead to new ways to help people avoid obesity or lose weight.", - "NCTID": "NCT02483663" - }, - { - "brief_title": "Dexamethasone and Wound Healing After Thyroid Surgery", - "phase": "", - "drugs": "['Dexamethasone', 'saline']", - "drugs_list": [ - "Dexamethasone", - "saline" - ], - "diseases": "['Wound Infection']", - "diseases_list": [ - "Wound Infection" - ], - "enrollment": "220.0", - "inclusion_criteria": "inclusion criteria: \n\n Elective total thyroidectomy or hemithyroidectomy with lymphadenectomy for thyroid cancer \n\n ", - "exclusion_criteria": ": \n\n Age > 65 years, < 18 years \n\n Thyroid tumor with Grave's disease \n\n Thyroid tumor size over 5 cm \n\n Second or more than 2 times for thyroid surgery \n\n Non-traditional pathway for thyroid surgery \n\n ASA > II \n\n Pharyngitis \n\n Smoking, alcohol drinking history \n\n Contraindication or long term use of dexamethasone (allege, ulcer bleeding history, et al)", - "brief_summary": "Dexamethasone is a potent glucocorticoid with analgesic and anti-emetic effects [1-3]. Perioperative single-dose dexamethasone therapy has been used for several purposes: to reduce post-operative nausea and vomiting (PONV), pain and sore throat. There are also some reports on beneficial effects of less cardiac arrhythmia, improved appetite and less edema from glucocorticoids. Preoperative small dose of dexamethasone was reported to prevent reversal laryngeal nerve injury and improve voice quality after thyroid surgery. While accepted wildly in clinical anesthesia practice, the immune-press related potential risks of side effects associated with dexamethasone, such as delayed wound healing, infection, as well as effects on blood sugar, make the use of perioperative single dose of glucocorticoid controversial. The effect of perioperative dexamethasone on wound healing varied with different types of surgery. The present study will observe the effect of dexamethasone on the safety of thyroid surgery.", - "NCTID": "NCT02304250" - }, - { - "brief_title": "Brief Tobacco Cessation Intervention", - "phase": "", - "drugs": "['The brief smoking cessation AWARD model', 'Placebo intervention']", - "drugs_list": [ - "The brief smoking cessation AWARD model", - "Placebo intervention" - ], - "diseases": "['Smoking']", - "diseases_list": [ - "Smoking" - ], - "enrollment": "13671.0", - "inclusion_criteria": "inclusion criteria: \n\n Outpatients aged 18 years or above \n\n Smoke on at least 1 day in the past 30 days \n\n Chinese residents able to communicate in Chinese (Mandarin or Cantonese) \n\n Has a telephone \n\n ", - "exclusion_criteria": ": \n\n Smokers currently receiving smoking cessation interventions \n\n Smokers currently enrolled in other smoking cessation trials \n\n Smokers who need special care on quitting and are not suitable for AWARD intervention (determined by his/her doctor) \n\n Smokers with communication difficulties (physical or cognitive condition)", - "brief_summary": "Traditional smoking cessation clinics and telephone quitlines are expensive and 'passive' as they require motivated smokers to visit the clinic or make a phone call to seek help. However, in most middle-resource countries, smoking cessation clinics are not well publicized. Most health care professionals (HCP) are not active in performing smoking cessation counselling to their patients. They are not aware of the available smoking cessation services or the benefits of such services and hence do not refer smokers to smoking cessation services. On the other hand, physicians play a critical role in reducing tobacco use by advising smoking patients to quit (Richmond, 1999). Physician's advice to quit smoking not only motivates smokers to quit but also increases their quitting confidence (Fiore et al., 2000; Ossip-Klein et al., 2000).~Brief smoking cessation interventions have been shown to be effective with strong evidence from randomized controlled trials (RCTs), however, it is no evidence to show that longer interventions are more effective than shorter interventions. If carried out in routine clinical practice by all physicians and other HCP, brief interventions can potentially benefit a great number of smokers and increase smoking cessation rate. Therefore, we propose to examine the effect of a brief smoking cessation counselling intervention (10-20 seconds AWARD model) among patients using a randomized controlled trail (RCT) design in Guangdong province, China~This project aims to evaluate the effect of physicians' brief smoking cessation intervention (AWARD model) in real busy clinic settings using a randomized controlled trial (RCT) design.", - "NCTID": "NCT02494960" - }, - { - "brief_title": "Lidocaine: Effect of Lidocaine in Chronic Cough", - "phase": "Phase 4", - "drugs": "['10 % Lidocaine', '10 % Lidocaine', '0.9% saline']", - "drugs_list": [ - "10 % Lidocaine", - "10 % Lidocaine", - "0.9% saline" - ], - "diseases": "['Chronic Cough']", - "diseases_list": [ - "Chronic Cough" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female subjects, age 18 years and over. \n\n History of cough for more than 8 weeks. \n\n Normal chest x ray \n\n Chronic idiopathic cough or chronic cough resistant to treatment of specific triggers. \n\n ", - "exclusion_criteria": ": \n\n Smoking status: \n\n Current smokers \n\n Ex smokers with history of smoking > 20 pack years or those who have given up < 6 months ago. \n\n Prohibited medications: \n\n Use of medications likely to suppress / affect cough including codeine, morphine, pregabalin, gabapentin, amitriptylline, angiotensin converting enzyme inhibitors (type 1) and baclofen. \n\n Use of any anti-arrhythmic medication. \n\n Use of cimetidine, beta blockers, or diuretics. \n\n Cardiovascular conditions: \n\n Sinoatrial disease, bradycardia or all types of heart blocks. \n\n History of ischaemic heart disease or heart failure. \n\n Clinically significant abnormal electrocardiogram (ECG) at Screening or Baseline. \n\n History of cardiac surgery \n\n Respiratory conditions: \n\n o Asthma. \n\n Central nervous system / Peripheral nervous system conditions: \n\n Epilepsy. \n\n Myasthenia gravis. \n\n Miscellaneous: \n\n History of hepatic or renal dysfunction. \n\n Porphyria \n\n History of hypersensitivity to Lidocaine or related drugs. \n\n Pregnancy or breast feeding. \n\n Participation in another trial within the preceding 6 weeks. \n\n Trauma or ulceration to oral mucosa. \n\n History of chest or upper airway infection within the past 6 weeks. \n\n Conditions which may affect cough response such as stroke, diabetes, Parkinson's Disease.", - "brief_summary": "People cough in order to clear their airways. Most coughs are caused by viruses and settle down by themselves, but some people develop persistent coughing which can be anywhere from 8 weeks to several years. This is called chronic cough. People with chronic cough find the symptom distressing and it can have a major impact on their quality of life. Patients with chronic cough often report a sensation at the back of their throat which makes them feel an urge to cough. There is some evidence that Lidocaine (an anaesthetic used during medical procedures) can suppress a person's cough when given to patients via a nebuliser (a machine that turns liquid into a fine mist).~It is currently unknown whether using a local anaesthetic, such as Lidocaine, in the form of a throat spray would successfully suppress a person's cough. A throat spray would be an easier treatment option in chronic cough patients. Thus, the investigators research aims to compare cough rates, severity and urge to cough scores between Lidocaine throat spray and nebulised Lidocaine.", - "NCTID": "NCT01252225" - }, - { - "brief_title": "The Effect of a Carbohydrate Drink on Cognitive Function and Exercise Performance", - "phase": "", - "drugs": "['Carbohydrate drink', 'Placebo']", - "drugs_list": [ - "Carbohydrate drink", - "Placebo" - ], - "diseases": "['Fatigue']", - "diseases_list": [ - "Fatigue" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n healthy, 18 to 35 year old man or woman. \n\n ", - "exclusion_criteria": ": \n\n smoker \n\n pregnancy \n\n taking part in other research. \n\n followed a weight loss diet in the previous 6 months. \n\n history of gastrointestinal, endocrine, cardiovascular disease or diabetes. \n\n neurological or psychiatric condition that may cause cognitive dysfunction.", - "brief_summary": "This study will investigate the effects of hydrothermally modified starch (SuperStarch) in adults. SuperStarch, originally developed as a drink for children with glycogen storage disease, is a slow digestible carbohydrate, maintaining blood sugar levels over extended periods. Therefore, it could be beneficial to exercise and mental performance, and could possibly have fat loss effects by increasing feelings of fullness. In this study, measures will be taken in 25 men to assess mental function, appetite, and metabolism to determine the processes involved in possible fat loss.", - "NCTID": "NCT02045342" - } - ], - "1": [ - { - "brief_title": "a Multicentric Randomized Controlled Trial of Self-Expandable Esophageal Radiation Stent", - "phase": "Phase 3", - "drugs": "['novel stent', 'conventional covered stent']", - "drugs_list": [ - "novel stent", - "conventional covered stent" - ], - "diseases": "['Esophageal Cancer']", - "diseases_list": [ - "Esophageal Cancer" - ], - "enrollment": "180.0", - "inclusion_criteria": "inclusion criteria: \n\n Endoscopically and histologically confirmed cancer of esophagus \n\n Progressive dysphagia caused by esophageal cancer, and the dysphagia grade of level \u2162 or level \u2163[STOOLER stand] \n\n In barium meal of esophagus, severe stricture of the cancer make the barium difficult to pass through and the superior normal esophagus broaden \n\n The bulk and shape of the oesophageal cancer displayed by CT three-dimensional reconstruction \n\n Patients with clear consciousness\uff0cCooperation\uff0cECOG performance status of 0,1 and 3 \n\n Informed consent: authorization and signature \n\n ", - "exclusion_criteria": ": \n\n Poor general status,ECOG performance status of 4, \n\n Dysphagia not caused by esophageal cancer, \n\n Noncooperation or no authorization and signature. \n\n The superior border of cancer higher than the seventh cervical vertebrae \n\n Ulcerative esophageal carcinoma \n\n Esophageal fistulas, \n\n WBC less than 3000/mm3 \n\n Severe hepatic inadequacy or renal inadequacy,", - "brief_summary": "Esophageal cancer is common in some areas , ranking as the fourth leading cause of death from cancer in China and sixth worldwide. Although the prognosis of surgical resection for esophageal cancer has been improved, more than 50% of such patients are inoperable and have to undergo palliative treatments because of late stage cancer or metastasis. Dysphagia is the predominate symptom of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the quality of life of such patients, brachytherapy has previously been utilized. Recently, stent placement has been widely accepted to be an option for palliation of the symptoms due to the esophageal strictures. Brachytherapy and esophageal self-expanding stent insertion have longer benefit. Stent insertion provides fastest improvement of dysphagia.However, recurrence of the neoplastic stricture remains a challenge after stent placement, complications in later setting occur and require further endoscopic treatment. Brachytherapy has slower onset of benefit but has fewer complications and longer benefit.To combine the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy, a novel esophageal stent loaded with 125I seeds has been developed in the authors' institute. The technical feasibility and safety with this new stent has been demonstrated to be adequate in a healthy rabbit model. And a small-sample and unicentric prior clinical trial in the authors' institute certificated the novel esophageal stent can relieve the dysphagia caused by advanced esophageal cancer rapidly and improve the quality of life markedly. This current multicentric randomized clinical trial is further studying the novel esophageal stent loaded with 125I seeds to see how well they work compared with a conventional covered stent in patients with malignant dysphagia caused by advanced esophageal cancer.", - "NCTID": "NCT01054274" - }, - { - "brief_title": "Quality of Life and Dysphagia Following Palliative Stenting in Esophageal Cancer", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Esophageal Cancer']", - "diseases_list": [ - "Esophageal Cancer" - ], - "enrollment": "13.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients with end stage inoperable esophageal cancer deemed candidates for intraluminal esophageal palliative stent insertions. \n\n ", - "exclusion_criteria": ": \n\n Inability to consent for the study. \n\n Patients less than 18 years old. \n\n Patients with other benign causes of dysphagia and esophageal obstruction or stenosis. \n\n Patients with malignant or benign airway - esophageal fistulas. \n\n Patients with cervical esophageal cancer", - "brief_summary": "This study consists of a prospective clinical trial which aims to evaluate the impact of stent insertion for palliation of malignant dysphagia. The main goal being to examine the number of days required following stenting in order to have significant improvement in dysphagia and the length of time that this baseline is maintained. Approximately 100 patients will be prospectively enrolled in this study.~Patients with end stage inoperable esophageal cancer deemed candidates for intraluminal esophageal palliative stent insertion will be prospectively enrolled into the study. Patients with esophageal obstruction or stricture due to other benign causes, tumors obstructing the cervical esophagus, as well as patients with airway-esophageal fistulas will be excluded from the study.~The investigators plan to evaluate the efficacy of intra-esophageal stent insertion to improve malignant dysphagia as a main factor affecting the quality of life in these patients.", - "NCTID": "NCT01471249" - }, - { - "brief_title": "Evaluation of Polyflex Stenting in Esophageal Cancer Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Esophageal Cancer']", - "diseases_list": [ - "Esophageal Cancer" - ], - "enrollment": "26.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years of age and older \n\n Willing and able to provide informed consent \n\n Willing to comply with follow-up requirements \n\n Biopsy-confirmed esophageal cancer (adenocarcinoma or squamous cell carcinoma) in mid or distal esophagus (clinical stage 3 or less) \n\n Indicated for chemotherapy and/or radiation therapy \n\n Ability to dilate stricture to 15mm diameter at extent of disease evaluation \n\n Placement of at least 18 x 23mm diameter and 120mm length PolyFlex stent \n\n ", - "exclusion_criteria": ": \n\n Patients contraindicated for endoscopy \n\n Patients with prior esophageal stent placements \n\n Advance stage of disease, greater than T3 tumor or M1 disease", - "brief_summary": "To evaluate the effectiveness of an esophageal stent as a way to maintain nutrition during radiation and/or chemotherapy treatment.", - "NCTID": "NCT00727376" - }, - { - "brief_title": "Optimal Management of Malignant Dysphagia", - "phase": "Phase 1", - "drugs": "['Brachytherapy', 'Stent insertion']", - "drugs_list": [ - "Brachytherapy", - "Stent insertion" - ], - "diseases": "['Malignant Dysphagia', 'Esophageal Cancer']", - "diseases_list": [ - "Malignant Dysphagia", - "Esophageal Cancer" - ], - "enrollment": "72.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u226518 years \n\n Confirmed esophageal/gastroesophageal (GEJ) cancer (Siewert Type I and Type II only) of any histology on biopsy \n\n Dysphagia score \u22652 \n\n Stage IV cancer/Metastatic disease \n\n ", - "exclusion_criteria": ": \n\n Expected life expectancy < 3 months \n\n Inability to undergo stent insertion \n\n Siewert Type III gastroesophageal cancer \n\n Esophageal-Airway fistula", - "brief_summary": "According to the Canadian Cancer Society there are approximately 1700 new cases of esophageal cancer per year in Canada. As most of these patients are diagnosed in advanced stages of the disease, 1800 deaths are estimated from this cancer annually . Progressive dysphagia is the most common presenting symptom and impacts not only the patient's quality of life but the ability to tolerate life prolonging treatments such as systemic chemotherapy.~Although there are several therapeutic modalities to alleviate malignant dysphagia including laser, photodynamic therapy and cryotherapy , the use of stents and radiotherapy are the most commonly employed. However, the optimal approach to effective, timely treatment of malignant dysphagia remains a challenge. The investigators conducted a preliminary retrospective review to investigate such palliation procedures and found that a multi-modality approach may yield the most favourable results .~Therefore, our clinical trial will examine the effectiveness of adding a single dose of brachytherapy to patients with severe dysphagia who have already been treated with a endoscopically placed self-expanding metallic stent.", - "NCTID": "NCT01366833" - }, - { - "brief_title": "Trial Using 125I Embedded Stent in Patients With Advanced Esophageal Cancer", - "phase": "", - "drugs": "['Esophageal stent placement']", - "drugs_list": [ - "Esophageal stent placement" - ], - "diseases": "['Esophageal Cancer']", - "diseases_list": [ - "Esophageal Cancer" - ], - "enrollment": "250.0", - "inclusion_criteria": "inclusion criteria: \n\n Histologically confirmed primary cancer of esophagus, \n\n Must be dysphagia caused by esophageal cancer, \n\n Without esophageal fistulas, \n\n Must be an inpatient, \n\n Life expectancy is over 6 months \n\n ", - "exclusion_criteria": ": \n\n Esophageal fistulas, \n\n Tracheal compression with symptoms, \n\n WBC <2000/mm3 and Platelet count <50,000/mm3, \n\n Concurrent therapies after stenting:surgery, chemotherapy,radiotherapy, Traditional Chinese Medicine", - "brief_summary": "More than half of patients with esophageal cancer are inoperable because of late stage cancer or metastasis and they have to undergo palliative treatments. Dysphagia is the major symptom of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the quality of life of such patients, stent placement has been widely accepted to be an option for palliation of the symptoms. However, recurrence of the neoplastic stricture remains a challenge after stent placement. To combine the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy, a novel esophageal stent loaded with 125I seeds has been developed in the authors' institute. The preliminary clinical trial in a single institute has demonstrated better results than the conventional stent. This prospective multiple center trial is designed to further demonstrate the clinical outcomes with this irradiation, stent in patients compared to those using a conventional covered stent.", - "NCTID": "NCT00826813" - }, - { - "brief_title": "Improve the Treatment of Thoracic Esophageal Cancer", - "phase": "Phase 3", - "drugs": "['adjuvant chemotherapy', 'standard two field Lymphadenectomy', 'Total two field Lymphadenectomy', 'three field Lymphadenectomy']", - "drugs_list": [ - "adjuvant chemotherapy", - "standard two field Lymphadenectomy", - "Total two field Lymphadenectomy", - "three field Lymphadenectomy" - ], - "diseases": "['Thoracic Esophageal Squamous Cell Carcinoma']", - "diseases_list": [ - "Thoracic Esophageal Squamous Cell Carcinoma" - ], - "enrollment": "301.0", - "inclusion_criteria": "inclusion criteria: \n\n Age\u226470 years old; \n\n Karnofsky Performance Status\uff08KPS\uff09\u226580; \n\n Pathological diagnosis is squamous cell carcinoma of thoracic esophageal which is treated initially; \n\n Clinical stage is c T 1 \n\n 3 N 0 \n\n 1 according to the results of endoscopic ultrasonography\uff0cchest and abdomen CT and neck ultrasonic. \n\n The preoperative evaluation of organ function is tolerant of surgery and chemotherapy; \n\n The subject can understand and sign the informed consent form (ICF); \n\n The following laboratory tests, made in 4 weeks before first medication, confirmed that bone marrow, liver and kidney function in line with the requirements to participate in research; Hemoglobin\uff08HGB\uff09\u22659.0g/L; absolute neutrophils count\uff08ANC\uff09\u22651.5\u00d7109/L; platelet count\uff08PLT\uff09\u2265100\u00d7109/L; total bilirubin\uff08TBIL\uff09\u22641.5N;aspartate aminotransferase (AST)\u22642.5N;alanine aminotransferase(ALT)\u22642.5N;prothrombin time(PT)\u22641.5N, and activated partial thromboplastin time(APTT) is in normal range;endogenous creatinine clearance rate(CRE)\u22641.5N. \n\n ", - "exclusion_criteria": ": \n\n Cervical esophageal cancer and Non-squamous cell carcinoma of thoracic esophageal cancer; \n\n Advanced Esophageal Cancer; \n\n Prior malignancy in 5 years recently; \n\n History of previous chest radiotherapy; \n\n History of cardio-cerebral vascular accident in 6 months lately; \n\n The subject can not understand and sign the informed consent form(ICF).", - "brief_summary": "The purpose of this study is~To compare the effects of the two types of thoracic esophageal cancer lymphadenectomy on the staging and prognosis of resectable esophageal cancer, which defined by the International Association of esophageal disease(ISDE) - standard mediastinal lymphadenectomy,total mediastinal lymphadenectomy and three field lymphadenectomy,and to find out reasonable range of lymphadenectomy.~To compare the effects of Chemotherapy Group (Docetaxel + Nedaplatin) with Control Group on the prognosis of resectable thoracic esophageal cancer,and to explore the indications of adjuvant chemotherapy.", - "NCTID": "NCT01137123" - }, - { - "brief_title": "Efficacy of Intensity Modulated Radiation Therapy After Surgery in Early Stage of Esophageal Carcinoma;", - "phase": "Phase 3", - "drugs": "['Prophylactic postoperative radiation therapy']", - "drugs_list": [ - "Prophylactic postoperative radiation therapy" - ], - "diseases": "['Esophageal Neoplasm', 'Esophageal Cancer TNM Staging Primary Tumor (T) T2', 'Esophageal Cancer TNM Staging Primary Tumor (T) T3', 'Esophageal Cancer TNM Staging Regional Lymph Nodes (N) N0', 'Esophageal Cancer TNM Staging Distal Metastasis (M) M0']", - "diseases_list": [ - "Esophageal Neoplasm", - "Esophageal Cancer TNM Staging Primary Tumor (T) T2", - "Esophageal Cancer TNM Staging Primary Tumor (T) T3", - "Esophageal Cancer TNM Staging Regional Lymph Nodes (N) N0", - "Esophageal Cancer TNM Staging Distal Metastasis (M) M0" - ], - "enrollment": "240.0", - "inclusion_criteria": "inclusion criteria: \n\n Stage T2-3N0M0 disease of TESCC patients confirmed by pathology studies who received R0 operations in Cancer Institute & Hospital\uff0cCAMS\uff1b \n\n KPS\u226570 before radiotherapy; \n\n Did not receive neoadjuvant or adjuvant treatment; \n\n No clear recurrent or metastatic lesions before radiotherapy; \n\n Intensity modulated radiation therapy(IMRT) is accepted; \n\n Regular follow-up. \n\n ", - "exclusion_criteria": ": \n\n Exploratory thoracotomy or palliative surgery; \n\n No clear recurrent or metastatic sites; \n\n Recurrence or metastasis is not certain; \n\n death of no definite cause. \n\n Irregular follow-up;", - "brief_summary": "The purpose of this study is to determine the efficacy of preventive intensity modulated radiation therapy after surgery in stage T2-3N0M0 disease of thoracic esophageal squamous cell carcinoma(UICC 7th edition) and to identify the subgroup benefiting from the treatment.", - "NCTID": "NCT01745107" - }, - { - "brief_title": "Radiation Therapy + Combination Chemotherapy as 1st-Line Therapy for Patients With Inoperable Esophageal Cancer", - "phase": "Phase 2; Phase 3", - "drugs": "['cisplatin', '5-FU', 'oxaliplatin', 'radiation therapy', 'Folinic Acid']", - "drugs_list": [ - "cisplatin", - "5-FU", - "oxaliplatin", - "radiation therapy", - "Folinic Acid" - ], - "diseases": "['Esophageal Cancer']", - "diseases_list": [ - "Esophageal Cancer" - ], - "enrollment": "266.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Histologically proven adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the esophagus \n\n Locally advanced disease (any T, N0 or N1, M0 or M1a) \n\n No metastatic disease, except for tumor involvement of the upper third of the esophagus or cervical esophageal tumor with regional nodes, or tumor involvement of the lower third of the esophagus with celiac nodes (M1a) \n\n Cervical primary tumor with positive supraclavicular or cervical lymph nodes (defined as N1) allowed \n\n No radiographic evidence of enlarged (\u2265 1.5 cm) celiac lymph nodes by CT scan or echography \n\n No small cell or undifferentiated carcinoma of the esophagus \n\n No multiple carcinomas of the esophagus (i.e., > 1 esophageal tumor) \n\n No cardia tumor (Siewert II) or gastric tumor extension to the esophagus (Siewert III) \n\n Esophageal tumor extension to the cardia (Siewert I) (center of the tumor lying > 1 cm-5 cm above gastroesophageal junction) allowed \n\n Inoperable disease OR surgery is contraindicated \n\n No tracheo-esophageal fistula or invasion of the tracheo-bronchial tree \n\n PATIENT CHARACTERISTICS: \n\n ECOG performance status 0-2 \n\n Life expectancy \u2265 3 months \n\n Absolute neutrophil count \u2265 1,500/mm\u00b3 \n\n Platelet count \u2265 100,000/mm\u00b3 \n\n Hemoglobin \u2265 10 g/dL (transfusion allowed) \n\n Creatinine < 15 mg/L \n\n Total bilirubin < 1.5 times upper limit of normal (ULN) \n\n ALT and AST < 2.5 times ULN \n\n Prothrombin time \u2265 60% \n\n Not pregnant or nursing \n\n Fertile patients must use effective contraception \n\n Caloric intake sufficient (i.e., > 1,000 Kcal/m\u00b2/day) (orally or with gastrostomy) \n\n No weight loss > 20% normal body weight within the past 3 months \n\n No complete dysphagia \n\n No exclusive requirement for parenteral nutrition \n\n No peripheral neuropathy > grade 1 \n\n No sensitive peripheral neuropathy with functional impairment \n\n No auditory disorders \n\n No other prior malignancies except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix or stage I or II node-negative head and neck cancer that was curatively treated > 3 years ago \n\n No myocardial infarction within the past 6 months \n\n Patients who have had a myocardial infarction > 6 months ago are eligible provided there is no transient ischemia by thallium myocardial scintigraphy and patient is able to undergo chemotherapy , as determined by a cardiologist \n\n No other serious illness or medical condition (e.g., symptomatic coronary disease, left ventricular failure, or uncontrolled infection) \n\n No stage II-IV arterial disease, according to the DE LERICHE and FONTAINE classification \n\n No geographical, social, or psychological circumstances preventing regular follow-up \n\n PRIOR CONCURRENT THERAPY: \n\n No prior treatment for esophageal cancer (e.g., surgery, chemotherapy, or radiotherapy) \n\n No prior cervical, thoracic, or abdominal radiotherapy with field overlapping the proposed esophageal radiotherapy field \n\n More than 30 days since prior experimental drugs or participation in another clinical trial \n\n No other concurrent anticancer therapy \n\n No concurrent phenytoin or yellow fever vaccine \n\n No concurrent high-dose, long-term corticosteroids \n\n No concurrent calcium gluconate/magnesium sulfate infusions \n\n No concurrent hematopoietic growth factors \n\n No concurrent esophageal dilatation", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.~PURPOSE: This randomized phase II/III trial is studying radiation therapy and two different combination chemotherapy regimens to compare how well they work as first-line therapy in treating patients with esophageal cancer that cannot be removed by surgery.", - "NCTID": "NCT00861094" - }, - { - "brief_title": "Genes in Predicting Outcome in Patients With Esophageal Cancer Treated With Cisplatin, Radiation Therapy, and Surgery", - "phase": "", - "drugs": "['loss of heterozygosity analysis', 'polymerase chain reaction', 'polymorphism analysis']", - "drugs_list": [ - "loss of heterozygosity analysis", - "polymerase chain reaction", - "polymorphism analysis" - ], - "diseases": "['Esophageal Cancer']", - "diseases_list": [ - "Esophageal Cancer" - ], - "enrollment": "118.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Diagnosis of adenocarcinoma of the esophagus \n\n Stage I-IV disease \n\n Received cisplatin-based treatment on clinical trial ECOG-1201 \n\n PATIENT CHARACTERISTICS: \n\n Not specified \n\n PRIOR CONCURRENT THERAPY: \n\n Not specified", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Studying samples of tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict a patient's response to treatment.~PURPOSE: This laboratory study is looking at genes to see if they can predict outcome in patients with esophageal cancer treated with cisplatin, radiation therapy, and surgery.", - "NCTID": "NCT00898495" - }, - { - "brief_title": "Surgery With or Without Chemotherapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus", - "phase": "Phase 3", - "drugs": "['cisplatin', 'fluorouracil', 'conventional surgery']", - "drugs_list": [ - "cisplatin", - "fluorouracil", - "conventional surgery" - ], - "diseases": "['Esophageal Cancer']", - "diseases_list": [ - "Esophageal Cancer" - ], - "enrollment": "240.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: Histologically confirmed esophageal squamous cell cancer that is stage T2-3 Nx M0 \n\n PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No second malignancy within 5 years except: Basal cell skin carcinoma Carcinoma in situ of the cervix \n\n PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether chemotherapy before surgery is more effective than surgery alone in treating cancer of the esophagus.~PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients with stage II or stage III cancer of the esophagus.", - "NCTID": "NCT00002897" - }, - { - "brief_title": "Combination Treatment of S-1 With Paclitaxel in Advanced Esophageal Cancer", - "phase": "Phase 2; Phase 3", - "drugs": "['S-1 and Paclitaxel', 'Paclitaxel and Cisplatin', '5-FU and Cisplatin']", - "drugs_list": [ - "S-1 and Paclitaxel", - "Paclitaxel and Cisplatin", - "5-FU and Cisplatin" - ], - "diseases": "['Esophageal Cancer']", - "diseases_list": [ - "Esophageal Cancer" - ], - "enrollment": "4.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who have histologically confirmed diagnosis of esophageal cancer without prior palliative treatment or an interval of at least 6 months from the last operation, adjuvant radiation therapy and adjuvant chemotherapy. If patients received adjuvant chemotherapy, paclitaxel and cisplatin must be excluded from the regiment or the total dosage of cisplatin must be less than 300mg/m2. \n\n - Patients must be 18 to 75 years old and both genders are eligible. \n\n - Patients must have measurable or evaluable disease with at least one tumor mass maximum diameter \u226510mm by multi-slice spiral CT or MR scan. If ordinary CT scan is used the tumor mass maximum diameter must \u2265 2cm. Imaging exam must be performed within 15 days from enrollment. \n\n - Patients must have an expected life expectancy of \u2265 3 months \n\n - Patients must have a performance status of \u2265 80 on the Karnofsky scale \n\n - Patients must have normal marrow function and the blood tests must be collected within 7 days from enrollment with a hemoglobin (HGB) of \u226590g/L, an white blood cell (WBC) counts of \u22654.0\u00d7109/L\uff0ca neutrophil count of \u22652.0\u00d7109/L, , a platelet count of \u2265100\u00d7109/L, a total bilirubin (TBil) of \u22641.0 upper normal limitation (UNL), a creatinine (Cr) of \u2264 1.0 UNL, alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of \u22642.5 UNL, Alkaline phosphatase (AKP) \u22645.0 UNL. For patients with liver metastasis, the ASAT/ALAT must be \u22645.0 UNL. \n\n - Patients must have normal electrocardiogram results and no history of congestive heart failure. \n\n - Patients must be with good compliance and agree to accept follow-up of disease progression and adverse events. \n\n - Patients must give written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors \n\n ", - "exclusion_criteria": ": \n\n Patients who have received prior palliative treatment or less than 6 months from the last operation, adjuvant radiotherapy, adjuvant chemotherapy. \n\n Previous treatment regiment involve paclitaxel and S-1 \n\n Tumor mass >10mm by CT or MR scan. The total area of metastatic tumor lesions in liver is over 50% of whole liver or the total area of metastatic tumor lesions in lung is over 25% of whole lung. \n\n Patients without measurable or evaluable disease, for example cavity effusion or diffusive metastasis of organs. \n\n Patients with history of other tumors except for those of cervical carcinoma in situ or skin basal cell carcinoma who had been completely treated and without relapse in last 5 years. \n\n Patients with serious diseases such as congestive heart failure, uncontrolled myocardial infarction and arrhythmia, liver failure and renal failure. \n\n Patients with only brain metastasis or bone metastasis \n\n Patients with chronic diarrhea \n\n Patients with neurological or psychiatric abnormalities including metastasis of the central nervous system that affect cognitive. \n\n Pregnant or lactated women (premenopausal women must give urine pregnancy test before enrollment).", - "brief_summary": "Esophageal cancer is one of the common malignant disease, especially in China. The annual incidence of esophageal squamous cell carcinoma is 260,000 with the motility of 210,000. The prognosis of esophageal cancer is very poor. About 50% of patients have advanced disease at diagnosis and the natural course is only 6-8 months with a 5-year survival rate of 5-7%. Though some patients received surgical treatment, disease will recurrent and metastasis in nearly 90% of the patients.~In past decades, there isn't much improvement of the outcome and survival of advanced esophageal cancer due to the lack of effective chemotherapy agents. The traditional chemotherapy drugs include 5-fluorouracil and cisplatin and the combination of them results in a 25-35% response rate in both first-line and palliative treatment. Paclitaxel plus cisplatin regiment is another promising treatment of esophageal cancer and have been proved effective in many studies. One of our previous study showed paclitaxel and cisplatin treatment resulted in encouraging response rate with manageable side-effects in 131 patients of advanced esophageal cancer.~However, the toxicities of paclitaxel and cisplatin limit their combination in clinic. For example, the polyoxyethylene castor oil paclitaxel could induce acute hypersensitivity reactions and neurotoxicity. Cisplatin could result in dysfunction of kidney and neurotoxicity. In addition, most of esophageal cancer patients are age 65 to 70. Many of them have simultaneously other diseases such as hypertension, diabetes, and chronic kidney disease which cause varying damages of renal function and limit the use of cisplatin in these patients. Therefore, it is urgent for doctors to seek an alternative of cisplatin in the combination chemotherapy treatment.~Therefore, the investigators designed this randomized clinical trial in which a novel combination of S-1 with paclitaxel is used to treat advanced esophageal cancer patients in compare with paclitaxel/cisplatin and 5-FU/cisplatin treatment to explore its efficacy and toxicity. The investigators hope this study will provide some clues for the treatment of esophageal cancer patients.", - "NCTID": "NCT01704690" - }, - { - "brief_title": "Biological Factors in Predicting Response to Treatment in Patients With Esophageal Cancer or Rectal Cancer", - "phase": "", - "drugs": "['gene expression analysis', 'mutation analysis', 'polymorphism analysis', 'laboratory biomarker analysis', 'biopsy', 'endoscopic biopsy']", - "drugs_list": [ - "gene expression analysis", - "mutation analysis", - "polymorphism analysis", - "laboratory biomarker analysis", - "biopsy", - "endoscopic biopsy" - ], - "diseases": "['Colorectal Cancer', 'Esophageal Cancer']", - "diseases_list": [ - "Colorectal Cancer", - "Esophageal Cancer" - ], - "enrollment": "160.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or rectum \n\n Planning to receive neoadjuvant treatment, including radiotherapy or chemoradiotherapy \n\n PATIENT CHARACTERISTICS: \n\n Not pregnant or nursing \n\n No blood disorder \n\n Not deprived of freedom or protected by law \n\n PRIOR CONCURRENT THERAPY: \n\n See Disease Characteristics", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.~PURPOSE: This clinical trial is studying how well biological factors work in predicting response to treatment in patients with esophageal cancer or rectal cancer.", - "NCTID": "NCT00628368" - }, - { - "brief_title": "Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer", - "phase": "Phase 2", - "drugs": "['cisplatin', 'fluorouracil', 'paclitaxel', 'conventional surgery', 'neoadjuvant therapy', 'radiation therapy']", - "drugs_list": [ - "cisplatin", - "fluorouracil", - "paclitaxel", - "conventional surgery", - "neoadjuvant therapy", - "radiation therapy" - ], - "diseases": "['Esophageal Cancer']", - "diseases_list": [ - "Esophageal Cancer" - ], - "enrollment": "21.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Histologically confirmed adenocarcinoma, squamous cell, adenosquamous, or undifferentiated carcinoma of the esophagus or gastroesophageal junction \n\n Potentially resectable disease \n\n No malignant celiac node involvement \n\n No cervical esophageal carcinoma \n\n PATIENT CHARACTERISTICS: \n\n Age: \n\n 18 and over \n\n Performance status: \n\n ECOG 0-2 \n\n Life expectancy: \n\n Not specified \n\n Hematopoietic: \n\n Absolute neutrophil count at least 1,800/mm^3 \n\n Platelet count at least 100,000/mm^3 \n\n Hepatic: \n\n Bilirubin no greater than 1.5 times upper limit of normal (ULN) \n\n AST no greater than 3 times ULN \n\n Renal: \n\n Creatinine no greater than 1.5 mg/dL OR \n\n Creatinine clearance at least 60 mL/min \n\n Other: \n\n No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix \n\n No significant medical or psychiatric illness that would preclude study \n\n Not pregnant or nursing \n\n Fertile patients must use effective contraception during and for at least 3 months after study \n\n PRIOR CONCURRENT THERAPY: \n\n Biologic therapy: \n\n Not specified \n\n Chemotherapy: \n\n No prior chemotherapy for esophageal cancer \n\n Endocrine therapy: \n\n Not specified \n\n Radiotherapy: \n\n No prior thoracic radiotherapy \n\n Surgery: \n\n See Disease Characteristics \n\n No prior surgical resection of esophageal tumor", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.~PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have esophageal cancer.", - "NCTID": "NCT00021320" - }, - { - "brief_title": "Efficacy Comparison Study of Combination Regimens to Treat Advanced Esophageal Squamous Cell Carcinoma", - "phase": "Phase 2", - "drugs": "['Capecitabine plus cisplatin(XP) versus capecitabine plus paclitaxel(XT)']", - "drugs_list": [ - "Capecitabine plus cisplatin(XP) versus capecitabine plus paclitaxel(XT)" - ], - "diseases": "['First Line Chemotherapy', 'Capecitabine Plus Cisplatin Versus Capecitabine Plus Paclitaxel', 'Advanced or Recurrent Esophageal Squamous Cell Carcinoma']", - "diseases_list": [ - "First Line Chemotherapy", - "Capecitabine Plus Cisplatin Versus Capecitabine Plus Paclitaxel", - "Advanced or Recurrent Esophageal Squamous Cell Carcinoma" - ], - "enrollment": "94.0", - "inclusion_criteria": "inclusion criteria: \n\n Histologically confirmed metastatic, or recurrent esophageal squamous cell carcinoma \n\n Age > 18 years \n\n ECOG performance status 0 - 2 \n\n At least one measurable lesion(s) by RECIST criteria \n\n Life expectancy \u2265 3 months \n\n Patients may have received prior adjuvant chemotherapy with 5-FU with cisplatin as long as it has been 12 months since completion of regimen. \n\n No previous palliative chemotherapy \n\n Prior radiotherapy must be completed 4 weeks before study entry. \n\n Adequate bone marrow function (\u2265 ANC 1,500/ul, \u2265 platelet 100,000/ul, \u2265 Hemoglobin 9.0 g/dl) \n\n Adequate renal function (\u2264 serum creatinine 1.5 mg/dl or CCr \u2265 50 ml/min) \n\n Adequate liver function (\u2264 serum bilirubin 1.5 mg/dl, \u2264 AST/ALT x 3 upper normal limit) \n\n Written informed consent \n\n ", - "exclusion_criteria": ": \n\n Other tumor types such as adenocarcinoma, small cell carcinoma \n\n Evidence of CNS metastasis \n\n Contraindication to any drug contained in the chemotherapy regimen \n\n Previous adjuvant treatment with 5-FU, cisplatin, capecitabine or paclitaxel finished less than 1 year \n\n Evidence of serious gastrointestinal bleeding \n\n History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix \n\n Clinically significant cardiac disease (e.g. severe non-compensated hypertension, non-compensated heart failure, dilated cardiomyopathy, and coronary heart disease with ST segment depression in ECG) or myocardial infarction within the last 6 months. \n\n Serious pulmonary conditions/illness (e.g. chronic lung disease with hypoxemia) \n\n Serious metabolic disease such as severe non-compensated diabetes mellitus \n\n History of significant neurologic or psychiatric disorders \n\n Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease \n\n Positive serology for the HIV \n\n Pregnant or lactating women", - "brief_summary": "Until today, the 5-FU/cisplatin combination is the reference regimen with 30-45% response rates, which is most commonly used to treat patients with metastatic, recurrent or locally advanced, unresectable squamous cell carcinoma of the esophagus. Because the classical dose schedule of this two-drug combination is cisplatin 100 mg/m2 day 1 and 5-FU 1000 mg/m2/day continuous infusion for 96-120 hr, prolonged administration time and mucosal toxicity are inconvenient to the patients with the aim of palliation. Capecitabine, which is oral prodrug of 5-FU and mimic continuously-infused 5-FU, is being investigated in phase I, II and III trials for the treatment of gastric, gastroesophageal, and esophageal cancers, primarily in the first-line metastatic setting. In our experience, capecitabine plus cisplatin combination (XP) as a first-line treatment for 45 patients with advanced or recurrent esophageal squamous cell carcinoma demonstrated a promising anti-tumor activity with 57% of response rate and showed tolerable toxicity with convenience.~Paclitaxel has been also investigated as monotherapy and in combination with cisplatin in patients with advanced esophageal cancer. A Dutch phase II study demonstrated that paclitaxel combination with carboplatin had shown an encouraging confirmed response rate of 59% with 51 patients with resectable esophageal cancer in neoadjuvant setting. Another Dutch phase II study showed 43% of response rate including 4% of CR with 8 months of response duration when paclitaxel plus cisplatin administration was given for patients with metastatic esophageal cancer. Although recently first-line palliative chemotherapy regimen in esophageal cancer has been investigated, many trials have failed to show superiority to 5-FU/cisplatin combination. Since we considered that XP or XT is more effective and convenient chemotherapy regimen than 5-FU/cisplatin, this randomized phase II study was planned to compare XP with XT in terms of efficacy and tolerability.", - "NCTID": "NCT00816634" - }, - { - "brief_title": "Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer", - "phase": "Phase 2", - "drugs": "['Nimotuzumab', 'Radiotherapy']", - "drugs_list": [ - "Nimotuzumab", - "Radiotherapy" - ], - "diseases": "['Esophageal']", - "diseases_list": [ - "Esophageal" - ], - "enrollment": "42.0", - "inclusion_criteria": "inclusion criteria: \n\n pathologically or cytology diagnosed phase II-III esophageal carcinoma or IV thoracic segments carcinoma with the supraclavicular lymph nodes metastasis. \n\n with the measureable lesion of the newly diagnosed the esophageal carcinoma. \n\n age 18-75 years old \n\n ECOG\u22642 \n\n Expect survival date \u22653 months \n\n without serious diseases of important organs \n\n signature in the inform consent. \n\n ", - "exclusion_criteria": ": \n\n pregnant or breast-feeding women or using a prohibited contraceptive method. \n\n with psychiatric diseases. \n\n with serious diseases or uncontrolled infection. \n\n with history of other tumors. \n\n participation other clinical trials within 1 month prior to inclusion in the trial. \n\n not the first antitumor treatment .", - "brief_summary": "Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The phase II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.", - "NCTID": "NCT02591784" - }, - { - "brief_title": "Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus", - "phase": "Phase 1", - "drugs": "['chemotherapy', 'cisplatin', 'paclitaxel', 'low-LET electron therapy', 'low-LET photon therapy']", - "drugs_list": [ - "chemotherapy", - "cisplatin", - "paclitaxel", - "low-LET electron therapy", - "low-LET photon therapy" - ], - "diseases": "['Esophageal Cancer']", - "diseases_list": [ - "Esophageal Cancer" - ], - "enrollment": "24.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: Histologically confirmed epidermoid carcinoma or adenocarcinoma of the esophagus eligible for potentially curative radiotherapy Disease in one of the following categories: Newly diagnosed Locoregional failure after prior resection with curative intent Positive microscopic margin after palliative resection of all gross disease Disease clinically limited to esophagus T 1-4, any N, M0 Gastroesophageal junction tumor allowed No positive pleural, pericardial, or peritoneal cytology No tracheobronchial invasion on bronchoscopy, including tracheoesophageal fistula \n\n PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Hematopoietic: WBC more than 4,000/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 65 mL/min per 1.73 square meters Cardiovascular: No NYHA class 3/4 status No cerebral vascular disease No hypertension Other: No severe uncontrolled diabetes No uncontrolled infection No other medical condition that precludes treatment No mental status abnormality that precludes comprehension of or compliance with treatment No active cancer arising at another primary site other than basal cell carcinoma of the skin or in situ cervical carcinoma \n\n PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients with cancer of the esophagus.", - "NCTID": "NCT00002711" - }, - { - "brief_title": "PET Scan in Patients With Lung and Esophageal Cancers That May Be Removed by Surgery", - "phase": "Phase 2; Phase 3", - "drugs": "['positron emission tomography', 'fludeoxyglucose F 18']", - "drugs_list": [ - "positron emission tomography", - "fludeoxyglucose F 18" - ], - "diseases": "['Esophageal Cancer', 'Lung Cancer']", - "diseases_list": [ - "Esophageal Cancer", - "Lung Cancer" - ], - "enrollment": "75.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: Histologically confirmed esophageal or non-small cell lung carcinoma Esophageal cancer: Biopsy proven esophageal carcinoma considered acceptable for curative esophageal resection Lung cancer: Stages IA-IIIB, T(any)N(any)M0 disease without pleural effusion, which constitutes locally advanced lung cancer Must be candidates for induction chemotherapy followed by surgical resection \n\n PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 160,000/mm3 Hepatic: Bilirubin no greater than 1.0 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance greater than 65 mL/min Other: Not pregnant Adequate contraception required of all fertile female patients \n\n PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No prior surgical mediastinal staging such as prior mediastinoscopy or Chamberlain procedures See Disease Characteristics", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 positron emission tomography (PET) scans, may improve the ability to detect lung and esophageal cancer or their recurrence.~PURPOSE: Phase II/III trial to study the effectiveness of fludeoxyglucose F 18 PET scans in measuring response to induction chemotherapy in patients with esophageal and lung cancer that may be removed by surgery.", - "NCTID": "NCT00002930" - }, - { - "brief_title": "Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma", - "phase": "Phase 2", - "drugs": "['Nimotuzumab combined with paclitaxel and cisplatin']", - "drugs_list": [ - "Nimotuzumab combined with paclitaxel and cisplatin" - ], - "diseases": "['Esophageal Squamous Cell Carcinoma Resectable']", - "diseases_list": [ - "Esophageal Squamous Cell Carcinoma Resectable" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Histological or cytologic diagnosis of Esophageal squamous cell carcinoma \n\n ECOG performance status 0-2 \n\n Age:18-70 years \n\n Joined the study voluntarily and signed informed consent form \n\n Patients must not have received any prior anticancer therapy \n\n Resectable disease, Stage IIA-IIIC, T2N0M0-T3N1M0\uff08AJCC 2009\uff09 \n\n Target lesions can be measured according to RECIST criteria \n\n No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin \u22659 g/dL, WBC\u22653x109/L, Neutrophils (ANC )\u22651.5x109/L, platelet count \u2265100x 109/L, TBIL<1.5 x ULN, ALT and AST \u2266 2.5 x ULN, creatinine \u2266 1.5 x ULN \n\n Use of an effective contraceptive for adults to prevent pregnancy \n\n Life expectancy of more than 3 months \n\n ", - "exclusion_criteria": ": \n\n Not suitable to surgery \n\n cervical Esophageal Carcinoma(distance of incisor tooth<19cm) \n\n early Esophageal Carcinoma(Stage I) \n\n complete esophageal obstruction\uff0cEsophageal perforation or hematemesis \n\n other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ \n\n pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives \n\n Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior 11\u3001 History of serious allergic or castor oil allergy 12\u3001 Patients who are not suitable to participate in the trial according to researchers", - "brief_summary": "A higher percentage of radical resection is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone for esophageal cancer. And neoadjuvant chemotherapy may improve overall survival after surgical resection. Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemotherapy in patients with resectable Esophageal Squamous Cell Carcinoma, and to further investigate its side-effect and toxicity", - "NCTID": "NCT01688700" - }, - { - "brief_title": "Gefitinib in Treating Patients With Esophageal Cancer That is Progressing After Chemotherapy", - "phase": "Phase 3", - "drugs": "['quality-of-life assessment']", - "drugs_list": [ - "quality-of-life assessment" - ], - "diseases": "['Adenocarcinoma of the Gastroesophageal Junction', 'Esophageal Cancer']", - "diseases_list": [ - "Adenocarcinoma of the Gastroesophageal Junction", - "Esophageal Cancer" - ], - "enrollment": "450.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Histologically confirmed esophageal cancer or gastroesophageal junction tumor including the following subtypes: \n\n Adenocarcinoma \n\n Squamous cell cancer \n\n Poorly differentiated epithelial malignancy \n\n Gastroesophageal junction with Siewert type I or II tumors \n\n Failure after no more than 2 prior chemotherapy regimens and 1 chemoradiation course \n\n Measurable or evaluable disease by CT scan \n\n Patients with brain metastases must be stable and have received cranial irradiation prior to entry \n\n PATIENT CHARACTERISTICS: \n\n WHO performance status 0-2 \n\n Serum bilirubin \u2264 3 times the upper limit of normal (ULN) \n\n AST/ALT \u2264 2.5 times ULN (\u2264 5 x in presence of liver metastases) \n\n Able to take oral tablets (whole or dispersed) \n\n No evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic allowed) \n\n No known severe hypersensitivity to gefitinib or any of the excipients of this product \n\n No prior other malignancy likely to confound results or interfere with gefitinib therapy \n\n No medical condition considered to interfere with the safe participation in the trial \n\n Not pregnant \n\n Fertile patients must use effective contraception \n\n PRIOR CONCURRENT THERAPY: \n\n See Disease Characteristics \n\n No chemotherapy (including oral) within the past 6 weeks \n\n No radiotherapy to site of measurable or evaluable disease within the past 4 weeks \n\n No other concurrent cytotoxic chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids) or experimental medications", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether gefitinib is more effective than a placebo in treating esophageal cancer.~PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works compared with a placebo in treating patients with esophageal cancer that is progressing after chemotherapy.", - "NCTID": "NCT01243398" - }, - { - "brief_title": "Perioperative Chemotherapy Compared To Neoadjuvant Chemoradiation in Patients With Adenocarcinoma of the Esophagus", - "phase": "Phase 3", - "drugs": "['5-Fluorouracil', 'Leucovorin', 'Oxaliplatin', 'Docetaxel', 'Carboplatin', 'Paclitaxel', 'Neoadjuvant radiation']", - "drugs_list": [ - "5-Fluorouracil", - "Leucovorin", - "Oxaliplatin", - "Docetaxel", - "Carboplatin", - "Paclitaxel", - "Neoadjuvant radiation" - ], - "diseases": "['Esophageal Adenocarcinoma (UICC TNM7)', 'Adenocarcinoma of the Esophagogastric Junction']", - "diseases_list": [ - "Esophageal Adenocarcinoma (UICC TNM7)", - "Adenocarcinoma of the Esophagogastric Junction" - ], - "enrollment": "438.0", - "inclusion_criteria": "inclusion criteria: \n\n Histologically verified adenocarcinoma of the esophagus according to the UICC definition (TNM7) \n\n Pre-treatment stage cT1N+, M0 or cT2-4a, N0/+, M0 \n\n Age \u226518 years \n\n No prior abdominal or thoracic radiotherapy \n\n ECOG Performance status 0-2 \n\n Adequate cardiac function ( Patients with a cardiac history (e.g. myocardial infarction, heart failure, coronary artery disease) should have a cardiology review) \n\n Adequate bone marrow function (WBC>3x10^9/l; Hb>9g/dl; platelets >100x10^9/l) \n\n Adequate respiratory function. Symptomatic Patients should have pulmonary function tests with FEV1 >65% of predicted) \n\n Adequate renal function (GFR >60ml/min) \n\n Adequate liver function (serum bilirubin <1.5x Upper level of Normal (ULN); AST <2.5x ULN and ALT <3x ULN (ULN as per institutional standard) \n\n written informed consent \n\n ", - "exclusion_criteria": ": \n\n Tumors of squamous or other non-adenocarcinoma histology \n\n Patients with advanced inoperable or metastatic esophageal adenocarcinoma \n\n Stage cT1N0 and cT4b \n\n Gastric carcinoma \n\n Prior chemotherapy for cancer, \n\n Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 months) \n\n Clinical significant lung disease (FEV1 <65% of predicted) \n\n Peripheral neuropathy Grade >1", - "brief_summary": "The trial is designed to investigate differences in outcome of patients with esophageal adenocarcinoma and junctional adenocarcinoma treated with perioperative (neoadjuvant + adjuvant) chemotherapy (FLOT) plus surgical resection versus neoadjuvant chemoradiation (CROSS) plus surgical resection.", - "NCTID": "NCT02509286" - }, - { - "brief_title": "The Effect of Caphosol\u00ae on the Development of Esophagitis in (N)SCLC Patients Treated With Concurrent Chemo/Radiotherapy", - "phase": "", - "drugs": "['Caphosol']", - "drugs_list": [ - "Caphosol" - ], - "diseases": "['Small Cell Lung Cancer', 'Non Small Cell Lung Cancer']", - "diseases_list": [ - "Small Cell Lung Cancer", - "Non Small Cell Lung Cancer" - ], - "enrollment": "55.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years or older \n\n Patients with histologically proven (N)SCLC (all histological subtypes), treated with concurrent chemo- and radiotherapy. \n\n Ability to understand the protocol and willing to provide written informed consent \n\n ", - "exclusion_criteria": ": \n\n Concurrent participation in a clinical trial in which the subject is taking or receiving any investigational agent that may affect the frequency, severity or duration of mucositis. \n\n Pre-existent esophagitis. \n\n Receiving investigational treatment for the prevention or treatment of mucositis. \n\n Prior irradiation to the lung or head and neck region.", - "brief_summary": "Rationale: In the Netherlands 1770 people are being diagnosed with SCLC (Small Cell Lung Cancer) and 8764 patients are being diagnosed with NSCLC (Non Small Cell Lung Cancer) in 2011. This is approximately 15% and 75% of all new diagnosed lungcancers. Part of them will need a combination of chemo-radiationtherapy. A review of the incidence and severity of esophagitis in (N)SCLC patients receiving a combination of chemotherapy and once daily radiotherapy revealed overall esophagitis rates up to 58% experiencing esophagitis grade 2 and higher. As concurrent radiotherapy is moving to twice daily radiation (30 x 1,5 Gy in 3 weeks or 30-35 x 2 Gy in 3 weeks) it is expected that the incidence of esophagitis will rise, the clinical symptoms are likely to arise earlier and become more severe.~Mucositis of the upper tractus digestivus is a serious adverse event leading to pain, problems with swallowing and decreased food intake. It has a negative infect on QoL and can lead to prolonged hospital stay and delayed cancer treatment. Physicians seek improvements in treatment modalities to improve these daily patient toxicities.~Caphosol\u00ae is an advanced electrolyte solution indicated as an adjunct to standard oral care in treating oral mucositis caused by radiation or high dose chemotherapy. Positive effects of Caphosol\u00ae oral rinse 4 times daily in a study with head and neck chemoradiation patients were found on the presence of mucositis and on oral comfort.~It's supposed that the pathogenesis of chemo- or radiotherapy induced mucositis is the same for the whole tractus digestivus. The appearance does differ due to differences in cell proliferation.~Swallowing Caphosol\u00ae after oral rinse could have a positive effect on esophageal mucositis on time of onset, severity and duration.~Objective: Adding the use of Caphosol\u00ae (rinsing and swallowing four times a day) to the standard of care for esophagitis/mucositis, reduces the incidence, onset, duration and severity of esophagitis in (N)SCLC patients, comparing to the standard of care alone.~Study design: A multi-centre, open, randomized prospective phase II study. Study population: 108 patients 18 years or older with histologically proven (N)SCLC (all histological subtypes), treated with concurrent chemo- and radiotherapy are estimated to be included in this study (2:1 ratio inclusion; 72 patients with Caphosol\u00ae and 36 patients without Caphosol\u00ae; \u03b1=0.05, power 80%).~Intervention (if applicable): 108 patients eligible for this study will be monitored during their (N)SCLC chemo/radiotherapy treatment. One group of 72 patients will receive Caphosol\u00ae, 4 times a day - next to the standard of care. Caphosol\u00ae will start at day 1 of treatment and will be continued until 3 weeks after the last radiotherapy (RT).Another group of 36 patients will receive only the current standard of care for esophagitis. The patients will be randomly assigned to one of the groups.~Main study parameters/endpoints: The primary objective is to estimate the incidence, onset, duration and severity of esophagitis in (N)SCLC patients undergoing radiation therapy with chemotherapy who receive Caphosol\u00ae.~Secondary study parameters/outcome of the study (if applicable):~To correlate components of esophagitis data with clinical outcomes (pain, dysphagia, analgetic use, oral intake, weight loss, infection, need for hospitalization, QoL)~Discontinuation or delay of chemotherapy due to esophagitis. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks are very small. The patient has to fill in a Esophagitis Daily Questionnaire and during regular visits QOL questionaires are performed.~Sputumswabs are collected on a weekly basis for determination of the microbiological flora of the mouth. During regular blood control max. 8 ml extra blood is taken for immunologic status research.~Caphosol\u00ae is a saturated calciumphosphate solution. The daily intake of calcium and phosphor when swallowing Caphosol\u00ae 4 times daily is far beyond the Acceptable Daily Intake (ADI)(< 5%). Compared to daily nutrients like milk (270 mg calcium per unit milk (225 ml)) or meat (200 mg phosphor per 100 g meat) the intake of calcium and phosphor due to Caphosol\u00ae is negligible and is considered safe.", - "NCTID": "NCT01809756" - }, - { - "brief_title": "Advanced Oesophageal Cancer Study to Compare Quality of Life and Palliation of Dysphagia.", - "phase": "Phase 3", - "drugs": "['Cisplatin', 'Radiotherapy', '5-Fluorouracil']", - "drugs_list": [ - "Cisplatin", - "Radiotherapy", - "5-Fluorouracil" - ], - "diseases": "['Esophagus Cancer']", - "diseases_list": [ - "Esophagus Cancer" - ], - "enrollment": "220.0", - "inclusion_criteria": "inclusion criteria: \n\n Biopsy proven Carcinoma of the oesophagus. \n\n Not a candidate for radical/curative treatment due to the advanced nature of the disease, presence of metastases, or intercurrent illness. (It should be noted that, patients with mediastinal nodes and no more distant disease maybe suitable for radical treatment). \n\n Symptomatic patients with dysphagia scores of \u2265 1 i.e. able to eat only some solids (see Mellow Scale appendix 1) \n\n Performance status ECOG \u2264 2 \n\n Patients must begin treatment within 2 weeks of randomization. \n\n Patient is at least 18 years old. \n\n Adequate haematological function to undergo chemotherapy. Peripheral blood - Neutrophils > 1.5 x 10^9/L - Platelets > 100 x 10^9/L \n\n Adequate renal function, Creatinine - Calculated clearance \u2265 50 ml/min \n\n Patients capable of childbearing are using adequate contraception. \n\n Written informed consent of patient. \n\n ", - "exclusion_criteria": ": \n\n Previous mega-voltage external beam Radiotherapy or brachy-therapy delivered to the region of the chest. \n\n Synchronous active malignancies. \n\n Pregnant or lactating patients. \n\n Patients unfit for any treatment component. \n\n Tracheo-oesophageal fistula. \n\n Stents in situ. \n\n Previous chemotherapy for Oesophageal Cancer \n\n CT scan of thorax and abdomen more than 8 weeks prior to randomization \n\n Full Blood Count, Biochemistry (including creatinine) and creatinine clearance more than 2 weeks prior to randomization", - "brief_summary": "To compare the treatment of gullet cancer with radiotherapy alone and assess the advantage and toxicity of adding chemotherapy. The hypothesis to be tested is as follows: That the addition of chemotherapy to a short course of radiation treatment improves the proportion of patients who achieve relief of dysphagia and improves quality of life compared to radiation alone in patients with advanced oesophageal cancer.", - "NCTID": "NCT00193882" - }, - { - "brief_title": "Oropharyngeal Function After Radiotherapy With IMRT", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Head and Neck Neoplasms']", - "diseases_list": [ - "Head and Neck Neoplasms" - ], - "enrollment": "125.0", - "inclusion_criteria": "inclusion criteria: \n\n The target population for this study is 125 patients with stages III or IV squamous cell lesions of the oral cavity, oropharynx, pharynx or larynx, or unknown primary. \n\n ", - "exclusion_criteria": ": \n\n No patient will have had prior treatment for head and neck cancer or any otolaryngologic or neurologic disorder affecting swallow and no preexisting swallowing disorder.", - "brief_summary": "This project defines the effect on swallowing of intensity modulation during radiotherapy in an organ preservation treatment involving chemoradiation for 125 oral, laryngeal, and pharyngeal cancer patients with previously untreated Stage III or IV disease and to identify optimum treatment strategies. The specific aims are: 1) define the physiologic effects of chemoradiotherapy with IMRT to various sites in the upper aerodigestive/vocal tract including the cervical esophagus and the rate at which patients return to oral intake; 2) document the acute toxicities, late complications, locoregional failure and survival, and the relationship between fibrosis rating and the measure of laryngeal elevation; 3) determine whether the patient's swallowing mechanism can compensate for physiologic deficits in swallowing by introduction of interventions (postural changes, voluntary swallow maneuvers, several bolus volumes); 4) determine whether time to return to oral intake, effects of swallow maneuvers and/or volume, presence of an esophageal stricture and the duration of success of dilatation depends on radiation dose volume to specific structures in the head and neck; 5) define the relationship of tongue base pressure to development of esophageal stricture. Patients will be accrued from Northwestern University and University of Chicago. Effects are defined in terms of swallowing function, morbidity, toxicity and survival. Other outcome measures are the maintenance of voluntary control (flexibility) of the oropharyngeal region as indicated by the ability to correctly produce swallow maneuvers; and positive changes in cricopharyngeal opening duration with normal bolus volume shifts. Patients will be studied pretreatment, and at 1 month, 3 months, 6 months, 12 months, and 24 months post completion of chemoradiation. At each assessment, patients will receive a videofluoroscopic assessment of swallowing utilizing a standard protocol, assessment of xerostomia, mucositis, and fibrosis as well as assessment of disease status and quality of life scales. Head and neck cancer is a severe problem that affects public health. Most current treatments are a combination of radiotherapy with chemotherapy, which can result in severe swallowing problems which may make patients unwilling to accept this type of treatment. This project attempts to quantify the swallow problems associated with this specific treatment and the effects of interventions for these swallow problems.", - "NCTID": "NCT00506324" - }, - { - "brief_title": "Study of Combination of Cetuximab and Radiotherapy Added to the Standard Treatment for Oesophageal Adenocarcinoma", - "phase": "Phase 2", - "drugs": "['cetuximab', 'radiotherapy to oesophageal tumour']", - "drugs_list": [ - "cetuximab", - "radiotherapy to oesophageal tumour" - ], - "diseases": "['Resectable Esophageal Cancer']", - "diseases_list": [ - "Resectable Esophageal Cancer" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria: \n\n Histologically proven resectable adenocarcinoma of the lower oesophagus and gastric-oesophageal junction \n\n Tumour stage: T2-3 N0-1 M0, as assessed by endoscopic ultrasound and CT-scan of thorax and abdomen and ultrasound neck region. For the patients treated in this study the gastro-oesophageal junctional tumors will be staged as oesophageal tumors with respect to their lymphnode metastases. \n\n Age >18y and written informed consent after at least 4 days of deliberation time from the moment the patient information has been given and has been explained. \n\n Weight loss < 10% in 0.5 yr \n\n WHO performance status 0-1 \n\n No prior radiotherapy or chemotherapy for the adenocarcinoma of the oesophagus \n\n ", - "exclusion_criteria": ": \n\n Previous malignancy other than basal cell carcinoma of the skin or local resection for cervical carcinoma in situ. \n\n Inadequate organ function as defined by: \n\n Inadequate haematology (Hb < 5,5 mmol/L (red blood cell transfusions are allowed to increase the Hb at the discretion of the investigator) - neutrophils < 1,5 109/L -platelets <100*109/L), \n\n Liver enzyme elevation (bili > 1,5*ULN - ASAT > 2,5*ULN - ALAT > 2,5*ULN) or \n\n Impaired renal function (creatinine clearance by cockcroft < 60 cc/min) \n\n Proteinuria >1,0gr/24hr \n\n Tumour stage: M1a and/or tumour length > 8 cm and/or > 5 cm radially \n\n Major surgery within 4 weeks prior to the start of study treatment \n\n Bleeding disorder \n\n Known allergy to one of the study drugs used \n\n Use of any substance known to interfere with the chemotherapy clearance \n\n Previous radiotherapy to the chest \n\n Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments \n\n Uncontrolled angina pectoris; cardiac failure or clinically significant arrhythmias \n\n Continuous use of immunosuppressive agents \n\n Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine \n\n Prior exposure to anti-EGFR targeting agents. \n\n Hearing loss > 25 dB under normal \n\n Neurotoxicity > CTC grade 1 \n\n Pregnancy or breast feeding \n\n Patients (M/F) with reproductive potential not implementing adequate contraceptive measures", - "brief_summary": "The purpose of this study is to determine whether the addition of the combination between cetuximab and radiotherapy to the standard chemotherapy for resectable oesophageal cancer is safe and adds efficacy.", - "NCTID": "NCT00827671" - }, - { - "brief_title": "Dose-Guided Radiotherapy in Oesophageal Cancer: Managing the Real Dose", - "phase": "", - "drugs": "['with feeding/fluid instruction']", - "drugs_list": [ - "with feeding/fluid instruction" - ], - "diseases": "['Adenocarcinoma']", - "diseases_list": [ - "Adenocarcinoma" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Histologically proven adenocarcinoma of the gastro-oesophageal junction \n\n Age 18 years or older \n\n International Union Against Cancer (UICC) T2-4 N0-2 M0, potentially resectable disease treated by the CROSS regimen \n\n WHO 0-2 \n\n ", - "exclusion_criteria": ": \n\n Thoracic adenocarcinoma/squamous cell carcinoma \n\n Palliative treatment for the oesophageal cancer", - "brief_summary": "This study will prospectively collect patients undergoing the standard CROSS regimen in the neoadjuvant setting of the treatment for gastro-oesophageal cancer. The investigators will focus on the potential geometric differences between the OAR and target volume on the initial planning CT and on the kilovolt (kV) cone-beam computed tomography (CBCT). They expect a potential difference in the abdominal part of the planned target volume (PTV) and/or gastro-oesophageal junction part. Furthermore, the impact of gastric filling , potential tumor regression and the accuracy of 5 mm PTV margin in the thoracic PTV will be monitored.", - "NCTID": "NCT02130011" - }, - { - "brief_title": "Effects of Chemotherapy on Muscle Mass and Exercise Performance in Patients With Oesophageal Cancer.", - "phase": "", - "drugs": "['DEXA scan', 'Muscle biopsy', 'cardio-pulmonary exercise testing (CPEX)']", - "drugs_list": [ - "DEXA scan", - "Muscle biopsy", - "cardio-pulmonary exercise testing (CPEX)" - ], - "diseases": "['Oesophageal Adenocarcinoma']", - "diseases_list": [ - "Oesophageal Adenocarcinoma" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n oesophageal cancer \n\n Multidisciplinary team decision to offer neoadjuvant chemotherapy prior to surgery \n\n ", - "exclusion_criteria": ": \n\n Metastatic disease", - "brief_summary": "Curative treatment for oesophageal cancer involves undertaking chemotherapy followed by an operation to remove the tumour. Chemotherapy has several effects upon the body, including effects upon the systems that control the creation and breakdown of muscle. We aim to review these effects by recording changes in the amount of exercise patients are able to undertake after chemotherapy and reviewing changes in muscle mass.", - "NCTID": "NCT01742312" - }, - { - "brief_title": "Comparison of Efficacy and Frequency of Adverse Events of 1st Line Palliative Chemotherapy EOX and mDCF Regimens in Advanced HER2-negative Gastric Carcinoma", - "phase": "Phase 3", - "drugs": "['EOX', 'mDCF']", - "drugs_list": [ - "EOX", - "mDCF" - ], - "diseases": "['HER2 Negative Gastric Cancer']", - "diseases_list": [ - "HER2 Negative Gastric Cancer" - ], - "enrollment": "56.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients \u2265 18 years \n\n histologically confirmed inoperable locally advanced, recurrent, or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction; \n\n ECOG (Eastern Cooperative Oncology Group) performance status 0-2; \n\n adequate renal, hepatic, and hematologic function; \n\n measurable or nonmeasurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Patients with intraoperatively confirmed intraperitoneal metastases but without detectable disease in radiological studies were also eligible \n\n ", - "exclusion_criteria": ": \n\n HER2- positive tumors defined as either IHC 3+ or IHC 2+, the latter in combination with FISH+ \n\n previous chemotherapy for metastatic or locally advanced disease \n\n surgery <3 weeks before the onset of the study treatment \n\n congestive heart failure \n\n significant dysphagia that would preclude oral administration of capecitabine \n\n concurrent malignant disease, except for adequately treated tumors with high likelihood of being cured (e.g. basal cell carcinoma of the skin, cervical cancer) \n\n clinical evidence of brain metastases", - "brief_summary": "The purpose of the study is to compare efficacy and safety of palliative chemotherapy EOX and mDCF regimens in the first-line treatment of patients with advanced HER2-negative gastric and gastroesophageal junction (GEJ) adenocarcinoma", - "NCTID": "NCT02445209" - }, - { - "brief_title": "Nutritional Status and Barriers to Dietary Intake in Head and Neck Cancer Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Head and Neck Cancer']", - "diseases_list": [ - "Head and Neck Cancer" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years or older \n\n Diagnosed with head and neck cancer including the lip, oral cavity, salivary glands, paranasal sinuses, oropharynx, nasopharynx, hypopharynx, larynx, and thyroid \n\n All histological types of cancer \n\n All tumour stages according to American Joint Committee for Cancer (AJCC) Staging \n\n All forms of RT including standard or investigational and/or concurrent standard or investigational chemotherapy for head and neck cancers \n\n Alert and mentally competent \n\n English speaking \n\n ", - "exclusion_criteria": ": \n\n Unwilling to participate", - "brief_summary": "The investigators hope to learn more about how side-effects of RT or RTchemo affect food intake and nutrition status.", - "NCTID": "NCT00375180" - }, - { - "brief_title": "Docetaxel, Oxaliplatin, Capecitabine, Bevacizumab and Trastuzumab in Patients With Locally Advanced or Metastatic Gastric Cancer", - "phase": "Phase 2", - "drugs": "['Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab', 'Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab, Trastuzumab']", - "drugs_list": [ - "Docetaxel", - "Oxaliplatin", - "Capecitabin", - "Bevacizumab", - "Docetaxel", - "Oxaliplatin", - "Capecitabin", - "Bevacizumab", - "Trastuzumab" - ], - "diseases": "['Metastatic Gastric Cancer', 'Adenocarcinoma of the Gastro-oesophageal Junction']", - "diseases_list": [ - "Metastatic Gastric Cancer", - "Adenocarcinoma of the Gastro-oesophageal Junction" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable locally advanced or recurrent and/or metastatic disease not amenable to curative therapy. \n\n Measurable disease, according to the Response Evaluation Criteria in Solid Tumours (RECIST), assessed using imaging techniques (CT or MRI) \n\n ECOG Performance status 0, 1 or 2 (see Appendix 2) \n\n Life expectancy of at least 3 months \n\n Male or female age \u2265 18 years. \n\n Signed informed consent. \n\n Assessment of HER2 status (primary tumour or metastasis) by the central laboratory prior to initiation of study treatment (see section 9.1) \n\n Able to swallow and retain oral medication. \n\n LVEF \u2265 50% assessed by multigated radionucleotide angiography (MUGA) or cardiac ultrasound. \n\n ", - "exclusion_criteria": ": \n\n Any of the following will exclude the patient from the study: \n\n Previous chemotherapy for advanced/metastatic disease (prior peri-operative chemotherapy is allowed if at least 6 months has elapsed between completion of this therapy and enrolment into the study). \n\n Previous radiotherapy on the abdomen. \n\n Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma. \n\n Patients with active (significant or uncontrolled) gastrointestinal bleeding. \n\n Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity \u2265 grade 2 NCI-CTCAE. \n\n Creatinin clearance <50 mL/min. \n\n Neutrophil count <1.5 \u00d7 109/L, or platelet count <100 \u00d7 109/L. \n\n Serum bilirubin >1.5 \u00d7 upper limit of normal (ULN); or, AST or ALT >2.5 \u00d7 ULN (or >5 \u00d7 ULN in patients with liver metastases); or, alkaline phosphatase >2.5 \u00d7 ULN (or >5 \u00d7 ULN in patients with liver metastases, or >10 \u00d7 ULN in patients with bone but no liver metastases); or, albumin <25 g/L. \n\n Known dihydropyrimidine dehydrogenase (DPD) deficiency. \n\n History of documented congestive heart failure; angina pectoris requiring medication; evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP >180 mmHg or diastolic BP >100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias. \n\n Patients with dyspnoea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy. \n\n Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed). \n\n Major surgery within 4 weeks of start of study treatment; serious or not healing wound. \n\n Known hypersensitivity to any of the study drugs, Chinese hamster ovary cell products or other murine or human recombinant antibodies. \n\n History or clinical evidence of brain metastases. \n\n Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes. \n\n Positive serum pregnancy test in women of childbearing potential. \n\n Subjects with reproductive potential not willing to use an effective method of contraception. \n\n Any investigational drug treatment within 4 weeks of start of study treatment. \n\n Radiotherapy within 4 weeks of start of study treatment (2 week interval allowed if palliative radiotherapy given to bone metastastic site peripherally and patient recovered from any acute toxicity) \n\n Arterial thrombosis; cerebrovascular accident within 6 months prior to study enrolment. \n\n Therapeutic use of oral coumarin-derived or LMWH anticoagulants or NSAIDs. \n\n Continuous use of immunosuppressive agents (for the use of corticosteroids see also #12).", - "brief_summary": "Background: It is estimated that in the Netherlands each year approximately 900 patients with gastric cancer or adenocarcinoma of the gastro-oesophageal junction are candidates for chemotherapy. Randomized studies comparing chemotherapy versus best supportive care have shown that survival and quality of life are prolonged with chemotherapy. However, no chemotherapy regimen is clearly superior with regard to prolongation of survival. Therefore, tolerability of treatment and ease of administration (outpatient compared to inpatient) are important considerations for the development of novel treatment schedules. Study design: This is an open-label, multicentre, phase II trial designed to evaluate the efficacy and safety of bevacizumab in combination with docetaxel, oxaliplatin and capecitabine chemotherapy (B-DOC) as first-line therapy in patients with inoperable locally advanced or recurrent and/or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction. In case of HER2 positive inoperable locally advanced or recurrent and/or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction trastuzumab is added to this regimen (B-DOCT).~Study Endpoints:~Primary endpoint Progression free survival defined as the time measured from B-DOCT study, Protocol version 3.0 dated January 18, 2011 Page 5 / 60 the day of registration to first progression or death. Secondary endpoints Toxicity Overall survival, defined as the time from registration to death Response rate defined as the percentage of partial and complete responses Duration of response defined as time from response to first progression Translational research on pharmacogenomic and biological factors that may predict treatment response.", - "NCTID": "NCT01359397" - }, - { - "brief_title": "Trastuzumab in Combination With Capecitabine and Oxaliplatin(XELOX) in Patients With Advanced Gastric Cancer(AGC): Her+XELOX", - "phase": "Phase 2", - "drugs": "['Herceptin+XELOX']", - "drugs_list": [ - "Herceptin+XELOX" - ], - "diseases": "['Metastatic or Recurrent Gastric Adenocarcinoma', 'Her-2 Positive Gastric Cancer']", - "diseases_list": [ - "Metastatic or Recurrent Gastric Adenocarcinoma", - "Her-2 Positive Gastric Cancer" - ], - "enrollment": "55.0", - "inclusion_criteria": "inclusion criteria: \n\n Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy. \n\n Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST), assessed using imaging techniques (CT or MRI). \n\n HER2 positive tumour (primary tumour or metastasis) defined as either IHC2+ and FISH+ or IHC3+ according to the gastric cancer scoring system for HER2 \n\n ECOG Performance status 0, 1 or 2 \n\n Life expectancy of at least 3 months. \n\n Male or female. Age over 20 year. \n\n Signed informed consent. \n\n ", - "exclusion_criteria": ": \n\n Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study; adjuvant/neoadjuvant therapy with platinum is not allowed). \n\n Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy tube). \n\n Patients with active (significant or uncontrolled) gastrointestinal bleeding. \n\n Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity over grade 2 NCI-CTCAE. \n\n Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma. \n\n Neutrophil count < 1.5 \u00d7 109/L, or platelet count < 100 \u00d7 109/L. \n\n Serum bilirubin > 1.5 \u00d7 upper limit of normal (ULN); or, AST or ALT > 2.5 \u00d7 ULN (or > 5 \u00d7 ULN in patients with liver metastases); or, alkaline phosphatase > 2.5 \u00d7 ULN (or > 5 \u00d7 ULN in patients with liver metastases, or > 10 \u00d7 ULN in patients with bone but no liver metastases); or, albumin < 25 g/L. \n\n Creatinine clearance < 60 mL/min. Other Study Drug-Related ", - "brief_summary": "This is an open-label, multicentre, prospective phase II trial designed to evaluate the efficacy and safety of trastuzumab in combination with capecitabine and oxaliplatin as first-line therapy in patients with recurrent and/or metastatic HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction.", - "NCTID": "NCT01396707" - }, - { - "brief_title": "Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV Head and Neck Cancer", - "phase": "Phase 3", - "drugs": "['cisplatin', 'fluorouracil', 'radiation therapy']", - "drugs_list": [ - "cisplatin", - "fluorouracil", - "radiation therapy" - ], - "diseases": "['Head and Neck Cancer']", - "diseases_list": [ - "Head and Neck Cancer" - ], - "enrollment": "69.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx \n\n No histologic diagnosis other than squamous cell carcinoma \n\n A primary site must be identified \n\n Must have locoregionally confined stage III (excluding T1-2, N1) or stage IV disease \n\n No evidence of nodal disease below the clavicles or distant hematogenous metastases (M0) \n\n No stage IVC disease (stage IVB disease allowed) \n\n Deemed appropriate for definitive non-operative management with curative intent \n\n Resectable disease is not required \n\n No primary cancer of the nasopharynx, paranasal sinus, or salivary gland \n\n PATIENT CHARACTERISTICS: \n\n ECOG performance status 0-1 \n\n WBC > 3,500/mm\u00b3 \n\n Platelet count > 100,000/mm\u00b3 \n\n Serum creatinine < 2.0 mg/dL \n\n Alkaline phosphatase < 2 times normal \n\n AST < 2 times normal \n\n Bilirubin \u2264 2.0 mg/dL \n\n Serum calcium normal \n\n Not pregnant or nursing \n\n Negative pregnancy test \n\n Fertile patients must use effective contraception \n\n No unstable or uncontrolled angina \n\n No clinically apparent jaundice \n\n No active infection \n\n No history of any other malignancy (except squamous cell or basal cell skin cancer or cervical carcinoma in situ), unless the patient has been continuously disease-free for at least 5 years \n\n Not a poor compliance risk \n\n Able to withstand the rigors of intensive treatment \n\n Available for and compliant with adequate long-term follow-up \n\n PRIOR CONCURRENT THERAPY: \n\n No prior definitive surgery or radiotherapy for this malignancy \n\n No prior chemotherapy, immunotherapy, or epidermal growth factor receptor inhibitors for any disease Patients who have had previous definitive surgery, or radiation therapy for this malignancy, and patients who have had any previous chemotherapy, immunotherapy, or EGF receptor inhibition for any disease are ineligible. \n\n ", - "exclusion_criteria": " Patients with primary cancers of the nasopharynx, paranasal sinus or salivary gland are ineligible. \n\n Patients with unstable or uncontrolled angina, clinically apparent jaundice, or active infection are ineligible. \n\n Patients with a history of any other malignancy (except squamous or basal cell skin cancer or cervical carcinoma in-situ) are ineligible, unless the patient has been continuously disease-free for at least 5 years. \n\n Patients with any histologic diagnosis other than squamous cell carcinoma are ineligible. \n\n Patients who might be a poor-compliance risk are ineligible. \n\n Pregnant or breastfeeding women are ineligible. Women/men of reproductive potential must be willing to practice acceptable methods of birth control to prevent pregnancy.", - "brief_summary": "RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin and fluorouracil may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without fluorouracil in treating patients with head and neck cancer.~PURPOSE: This randomized phase III trial is studying radiation therapy and cisplatin to compare how well they work with or without fluorouracil in treating patients with stage III or stage IV head and neck cancer.", - "NCTID": "NCT00608205" - }, - { - "brief_title": "TRIAD Burden of Illness Mucositis Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Gastrointestinal Mucositis (Defined as Mucositis Involving the Mouth, Esophagus, or Small Intestine)']", - "diseases_list": [ - "Gastrointestinal Mucositis (Defined as Mucositis Involving the Mouth", - "Esophagus", - "or Small Intestine)" - ], - "enrollment": "1600.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years or older \n\n Ability to understand the protocol and willing to provide written informed consent \n\n Membership in one of the following sub-cohorts: \n\n Histologically proven oral cavity or oropharyngeal cancers planned to receive a full cycle of daily single fraction radiation therapy (with or without boost) or IMRT +/- chemotherapy. \n\n Histologically proven laryngeal or hypopharyngeal cancers planned to receive a full cycle of daily single fraction radiation (with or without boost) +/- chemotherapy. \n\n Histologically proven adenocarcinoma of the colon or rectum planned to receive a minimum of 2 cycles of FOLFOX +/- Avastin or Erbitux.1 cycle defined as 2 doses of FOLFOX. \n\n Histologically proven adenocarcinoma of the colon or rectum planned to receive a minimum of 2 cycles of FOLFIRI +/- Avastin or Erbitux. 1 cycle defined as 2 doses of FOLFIRI. \n\n Adenocarcinoma of the breast planned to receive a minimum of 2 cycles of TAC. \n\n Histologically proven adenocarcinoma (any primary) planned to receive a minimum of 2 cycles of capecitabine. \n\n Adenocarcinoma of the breast planned to receive standard or dose-dense doxorubicin and cyclophosphamide (AC) followed by paclitaxel (T) (4 cycles AC followed by 2 cycles T). \n\n Stage 3A or 3B non-small cell lung cancers planned to receive daily single fraction radiation with or without boost (1 fraction daily for 5-6 weeks) +/- Carbo/Taxol. \n\n B-cell Non-Hodgkin's lymphoma (NHL) planned to receive at least 2 cycles of CHOP-14, CHOEP-14, CHOP-DI-14, EPOCH-14 or CHOP-21 +/- rituxan", - "exclusion_criteria": "", - "brief_summary": "Observational (non-drug) study to look at the risks and burden of mucositis (sores) involving the mouth, throat and intestines in patients receiving chemotherapy and radiation therapy treatment for various cancer types.", - "NCTID": "NCT00336609" - }, - { - "brief_title": "Sexual Behavior in Head and Neck Cancer Patients", - "phase": "", - "drugs": "['Questionnaire']", - "drugs_list": [ - "Questionnaire" - ], - "diseases": "['Oropharyngeal Cancer', 'Head and Neck Cancer', 'Squamous Cell Carcinoma']", - "diseases_list": [ - "Oropharyngeal Cancer", - "Head and Neck Cancer", - "Squamous Cell Carcinoma" - ], - "enrollment": "1500.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with newly diagnosed, previously untreated squamous cell carcinoma of the head and neck (SCCHN) who are candidates for the molecular epidemiology study LAB00-062 of head and neck cancer. \n\n Must have the ability to understand and provide informed consent. \n\n Patients must be 18 years and older. \n\n Ability to read, write, and speak English. \n\n Resident of the United States. \n\n Agrees to have tumor tissue, if available, tested for HPV. No additional biopsy will be requested. \n\n ", - "exclusion_criteria": ": \n\n Previous cancer diagnosis excluding non-melanoma skin cancer. \n\n Blood transfusion within the previous 6 months. \n\n Immune suppression, such as HIV disease or immune-suppressing therapy (i.e., steroids).", - "brief_summary": "The goal of this behavioral research study is to learn if certain sexual behaviors increase the risk for developing head and neck cancers associated with a virus called human papillomavirus (HPV-16). Knowing this information could help doctors better teach patients about avoiding certain risk factors, which may help to prevent the disease.", - "NCTID": "NCT00662662" - }, - { - "brief_title": "Study of Weekly Paclitaxel, Carboplatin and Irinotecan to Treat Lung Cancer", - "phase": "Phase 2", - "drugs": "['Paclitaxel, Carboplatin and Irinotecan']", - "drugs_list": [ - "Paclitaxel", - "Carboplatin and Irinotecan" - ], - "diseases": "['Lung Cancer']", - "diseases_list": [ - "Lung Cancer" - ], - "enrollment": "7.0", - "inclusion_criteria": "inclusion criteria: \n\n Histological or cytological diagnosis of non-small cell lung cancer. \n\n Malignant pleural effusion proven by cytological examination. \n\n Patient must have stage IIIB or IV disease with malignant pleural effusion. \n\n We plan to recruit 16 patients who have smoked cigarettes of at least 20 pack per year, 16 patients who do not smoke but have been exposed to second hand smoking by living with a person who has smoked 20 pack per year cigarette in the same household and 16 patients who are non-smokers (never smoked) and no second hand smoking exposure in the same household. The accrual will be stopped once the number of patients is reached in each group. \n\n ECOG PS 0, 1 or 2. \n\n Measurable disease (in addition to malignant pleural effusion). \n\n No prior chemotherapy for metastatic or recurrent disease. Patient may have surgery or radiation or combined chemoradiation, or neoadjuvant chemotherapy at primary diagnosis. This kind of chemotherapy will not be counted as patient has had prior chemotherapy for metastatic or recurrent NSCLC. \n\n WBC > 3500/uL and ANC > 2,000/uL, platelet > 100,000/uL AST/ALT < 3 X UNL, bilirubin < 1.5 mg/dL ( or < 35 uM), creatinine < 1.5 mg/dL (or < 125uM for men and 90uM for women). \n\n Age > 18 \n\n No history of congestive heart failure, myocardial infarction or life-threatening arrhythmia (such as ventricular tachycardia, supraventricular tachycardia, brachycardia < 40/min or atrial fibrillation or flutter with ventricular rate > 150/min) within 6 months of entry. \n\n Signed informed consent \n\n Negative mammogram and ovaries examination by CT scans and no history of breast cancer or ovarian cancer in female patients. \n\n Negative pregnancy test in female menstruating patient within one week of starting chemotherapy and use of effective contraceptive methods during study. \n\n Patients with brain metastasis will be eligible provided their neurological abnormality is stable or improved after whole brain radiation, stereostatic radiosurgery or gamma knife treatment and/or dexamethasone for 3 weeks and patients fulfil all other eligibility criteria. \n\n ", - "exclusion_criteria": ": \n\n ECOG performance status 3 or worse. \n\n Any prior chemotherapy regimen for metastatic or recurrent diseases. \n\n No measurable disease, even after drainage of pleural effusion. \n\n ANC < 1,999/uL or Bilirubin > 1.5 mg/dL (or > 35uM) \n\n Plt < 100,000/uL or \n\n ALT/AST > 3 x UNL \n\n Creatinine > 1.5mg/dL (or > 125uM) \n\n Patient has history of congestive heart failure, myocardial infarction or life-threatening arrhythmia (such as ventricular tachycardia, supraventricular tachycardia, atrial fibrillation/flutter with ventricular rate > 150/min or bradycardia < 40/min) within 6 months before entry. \n\n Prior history of breast cancer or ovarian cancer in female patients or any cancer except cured cervical carcinoma in-situ or skin cancer. \n\n Fasting blood sugar > 200 mg/dL (> 14uM) except in patients on dexamethasone for brain metastases.", - "brief_summary": "Evaluate the efficacy and toxicity of the weekly combination chemotherapy of Paclitaxel, Carboplatin and Irinotecan in Stage IIIb and IV NSCLC with malignant pleural effusion", - "NCTID": "NCT00465907" - } - ], - "2": [ - { - "brief_title": "Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia", - "phase": "", - "drugs": "['EGD with biopsies']", - "drugs_list": [ - "EGD with biopsies" - ], - "diseases": "['Esophagitis']", - "diseases_list": [ - "Esophagitis" - ], - "enrollment": "483.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients aged 18-90 presenting with dysphagia or food impaction \n\n Ability to undergo esophagogastroduodenoscopy and biopsies \n\n No significant cardiopulmonary disease, or other contraindication to EGD \n\n ", - "exclusion_criteria": ": \n\n Contradiction to EGD and/or biopsies such as Boerhaave's syndrome, or history or bleeding disorder or elevated INR \n\n Inability to provide informed consent \n\n Esophageal varices", - "brief_summary": "This is a prospective descriptive cross sectional study to determine the percentage of patients presenting with dysphagia who are found to have eosinophilic esophagitis (EoE) and to establish which presenting factors warrant esophageal biopsies. We hypothesize that a greater than expected percentage of patients who are biopsies will have histologic changes consistent with EE.", - "NCTID": "NCT00256529" - }, - { - "brief_title": "Evaluation of Two Different Thickening Products in Patients With Dysphagia", - "phase": "Phase 4", - "drugs": "['Thickenup', 'Thickenup Advance']", - "drugs_list": [ - "Thickenup", - "Thickenup Advance" - ], - "diseases": "['Dysphagia']", - "diseases_list": [ - "Dysphagia" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n History of dysphagia necessitating a dynamic fluoroscopic swallow study \n\n Age > 18 years \n\n Ability to complete a comprehensive dynamic fluoroscopic swallow study \n\n Ability to provide informed consent for study participation \n\n ", - "exclusion_criteria": ": \n\n Age < 18 years \n\n Pregnant women \n\n Prisoner or other institutionalized individual \n\n Cognitive disability precluding the ability to provide informed consent or complete a comprehensive swallow study", - "brief_summary": "Dysphagia is extremely common. The importance of providing adequate nutritional support to persons with dysphagia is the cornerstone to exceptional care. Diet modification with thickening agents is an essential aspect of this nutritional support. The purpose of this investigation is to compare the efficacy of a starch based (Thickenup or TU) to a gel based thickening agent (Thickenup Advance or TUA).", - "NCTID": "NCT01651975" - }, - { - "brief_title": "Biomarker Feedback for Smoking Cessation", - "phase": "", - "drugs": "['urine analyses feedback']", - "drugs_list": [ - "urine analyses feedback" - ], - "diseases": "['Cigarette Smoking']", - "diseases_list": [ - "Cigarette Smoking" - ], - "enrollment": "109.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female cigarette smokers, 18-75 years \n\n Smoked an average of less than 10 cigarettes per day during past month \n\n A personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. \n\n ", - "exclusion_criteria": ": \n\n Only one subject per household may participate \n\n Pregnancy", - "brief_summary": "The purpose of this study is to examine the impact of providing light smokers with feedback about their health, including exposure to tobacco-related chemicals.", - "NCTID": "NCT02206971" - } - ] - }, - { - "patient_id": "sigir-201420", - "patient": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", - "0": [ - { - "brief_title": "Plating of Humeral Shaft Fractures in Multiple Trauma Patients.", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Humeral Fractures', 'Multiple Trauma']", - "diseases_list": [ - "Humeral Fractures", - "Multiple Trauma" - ], - "enrollment": "96.0", - "inclusion_criteria": "inclusion criteria: \n\n age > 18 years \n\n patients with past (acute) traumatic humeral shaft fracture(s) treated with open reduction and internal fixation (ORIF) \n\n patients for whom the above fracture has healed \n\n patients willing and able to provide informed consent and able to participate in study procedures \n\n ", - "exclusion_criteria": ": \n\n patients with known pathological fractures \n\n patients with metabolic bone disease \n\n patients with humeral head or inter-articular surface fractures, or other upper extremity fractures \n\n patients with previous humeral surgery (i.e. rotator cuff, biceps tendon, etc.) \n\n patients with neurologic injury to upper extremities", - "brief_summary": "The purpose of this study is to review our experience with the operative management of acute diaphyseal fractures of the humerus via an anterolateral approach with the use of small fragment fixation at a Level I, urban, trauma center. We will report our clinical and radiographic results, complication rate and final range of motion. A standardized outcome measurement (DASH) will be reported. Muscle recovery of the triceps and biceps will be evaluated by a standard protocol, accomplished with the assistance of a licensed physical therapist. We hypothesize that open reduction and internal fixation of humeral diaphyseal fractures via an antero-lateral approach with the use of small fragment fixation is a safe and efficacious way to treat multiple trauma patients with these injuries.", - "NCTID": "NCT00720681" - }, - { - "brief_title": "Analgesic Efficacy of Morphine Alone or Combined With Paracetamol and/or Ibuprofen for Long-bones Fractures in Children", - "phase": "Phase 3", - "drugs": "['Paracetamol', 'Ibuprofen', 'paracetamol + ibuprofen', 'Placebo']", - "drugs_list": [ - "Paracetamol", - "Ibuprofen", - "paracetamol + ibuprofen", - "Placebo" - ], - "diseases": "['Pain', 'Long-bone Fractures']", - "diseases_list": [ - "Pain", - "Long-bone Fractures" - ], - "enrollment": "304.0", - "inclusion_criteria": "inclusion criteria: \n\n children aged 2 through 17 years (17 years included) \n\n suspected fracture of a long bone requiring morphine analgesia (VAS \u2265 60/100 or Evendol \u2265 7/15 at the arrival at emergency department) \n\n within the first 12 hours after the injury \n\n at least one signed parental informed consent \n\n affiliated to health insurance \n\n ", - "exclusion_criteria": ": \n\n analgesic treatment within the 6 hours before inclusion \n\n contraindication to one of the experimental drug: Paracetamol or Ibuprofen \n\n contraindication to Morphine \n\n cognitive impairment \n\n multiple injuries \n\n resuscitation man\u0153uvres \n\n suspected femur fracture \n\n open fracture \n\n pregnant women in the third trimester", - "brief_summary": "The main objective of this study is to evaluate the efficacy of two drugs: paracetamol and ibuprofen in association with morphine, compared with morphine alone on analgesia in children seen in the emergency department for a long-bone fracture and also to study the potential synergic effect of the association paracetamol and ibuprofen.", - "NCTID": "NCT02477007" - }, - { - "brief_title": "Association Between Craniofacial Fractures and Brain Injuries: Diagnostic and Therapeutic Considerations", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Brain Injuries', 'Skull Fractures']", - "diseases_list": [ - "Brain Injuries", - "Skull Fractures" - ], - "enrollment": "1000.0", - "inclusion_criteria": "inclusion criteria: \n\n Severe traumatic brain injury, GCS 8 or less and/or Craniofacial fracture \n\n ", - "exclusion_criteria": ": \n\n Died before admitted to hospital", - "brief_summary": "This study evaluates the association between traumatic brain injuries and craniofacial or/and skull fractures. Purpose is to find out the amount of missed diagnoses and improve primary diagnostics of trauma patients.", - "NCTID": "NCT02418169" - }, - { - "brief_title": "Chest Wall Repair of Rib Fractures After Trauma", - "phase": "", - "drugs": "['No intervention']", - "drugs_list": [ - "No intervention" - ], - "diseases": "['Rib Fractures']", - "diseases_list": [ - "Rib Fractures" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects must be at least >18 years of age \n\n Subjects must have one of the following clinical indications: \n\n >3 rib flail segments with paradoxical chest wall movement \n\n Non-repair of defect may result in pulmonary hernia \n\n Minimal associated injuries \n\n Severely displaced fractures are significantly impeding lung expansion. \n\n Failure of narcotics or epidural pain catheter to control pain \n\n ", - "exclusion_criteria": ": \n\n Significant pulmonary contusion \n\n Significant brain injury (AIS 4 and/or ICP monitoring) \n\n Severe associated injuries which, in the opinion of the surgeon will preclude operative chest wall stabilization \n\n Subjects not expected to survive the 90-day follow-up period \n\n Known pregnancy \n\n Prisoners", - "brief_summary": "This is a prospective, observational trial of 50 patients who have multiple, severe rib fractures following trauma. The investigators will follow their hospital stay for outcomes (infections, length of stay and medical care) as well as their early post-hospital course.", - "NCTID": "NCT00926991" - }, - { - "brief_title": "Pain Management in Geriatric Hip Fracture", - "phase": "Phase 2", - "drugs": "['Paracetamol tablet and Tramadol capsule', 'Panadol 500mg tablet, tramadol 50mg capsule']", - "drugs_list": [ - "Paracetamol tablet and Tramadol capsule", - "Panadol 500mg tablet", - "tramadol 50mg capsule" - ], - "diseases": "['Geriatric Hip Fracture Pain Management']", - "diseases_list": [ - "Geriatric Hip Fracture Pain Management" - ], - "enrollment": "400.0", - "inclusion_criteria": "inclusion criteria: \n\n Both sex of Age > 65 \n\n Traumatic non-pathological fracture neck of femur or trochanteric or subtrochanteric fracture having operative intervention \n\n ", - "exclusion_criteria": ": \n\n Age < 65 \n\n Pathological fracture \n\n Multiple lower limb fractures \n\n Old fracture", - "brief_summary": "The Null Hypothesis is that there is no association between Pain regime and the functional performance among geriatric patients having traumatic hip fracture. Two limbs are being assessed:1. Three weeks of regular oral Panadol and Tramadol after hip fracture 2. Oral Panadol and tramadol taking in p.r.n. basis. Functional outcome including Numerical Rate Scale for pain assessment, Functional Independency Measure and Elderly Mobility Score are chosen.", - "NCTID": "NCT01630343" - }, - { - "brief_title": "Effect of Remote Ischemic Conditioning on Trauma Patients With Hemorrhagic Shock", - "phase": "", - "drugs": "['Pneumatic tourniquet']", - "drugs_list": [ - "Pneumatic tourniquet" - ], - "diseases": "['Hemorrhagic Shock']", - "diseases_list": [ - "Hemorrhagic Shock" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u226516 years of age or estimated weight \u226550kgs if age is unknown; \n\n Victim of blunt or penetrating trauma \n\n Hemorrhagic shock defined as: \n\n One or more episodes of systolic blood pressure \u226490mmHg at any time prior to enrollment into the study; \n\n An identified source of blood loss (abdomen, chest, pelvis/retroperitoneum, extremities, external) or \n\n Blood products (RBC, Platelets, Plasma, etc.) has been ordered to the trauma room. \n\n Admitted to St. Michael's Hospital directly from the scene of injury within 3 hours of the injury \n\n Application and completion of Remote Ischemic Conditioning (RIC) within 4 hours of the injury \n\n ", - "exclusion_criteria": ": \n\n Pregnancy \n\n Non-hemorrhagic shock (i.e. tension pneumothorax, cardiac tamponade, spinal shock, etc.) \n\n Major burns > 20% total body surface area \n\n Fracture of both lower extremities (i.e. traumatic amputation, fractures) \n\n Absence of vital signs prior to admission, ongoing CPR, possibly dead on admission or not expected to survive beyond a few hours. \n\n Injury in both legs (traumatic amputation, fractures, etc.) \n\n Patients with a systolic blood pressure above 200mmHg \n\n Patients treated with anticoagulants, antiplatelet therapy (Warfarin, Aspirin), steroids or with a known bleeding disorder or known abnormality of blood flow to the limb (if known) \n\n Patients with osteoporosis or other bone disorders, peripheral nerve injury, abnormal nerve supply, peripheral neuropathy (if known) or preexisting traumatic injury to the limb. \n\n Morbid obesity (largest cuff size won't fit) \n\n If RIC is done clinically before research protocol begins.", - "brief_summary": "The purpose of the study is to evaluate whether remote ischemic conditioning is a safe and effective intervention to prevent the development of inflammation and coagulopathy in trauma patients with hemorrhagic shock.", - "NCTID": "NCT02071290" - }, - { - "brief_title": "Examination of Microcirculation of the Caput Humeri After Proximal Humerus Fracture", - "phase": "", - "drugs": "['Measurement with O2C']", - "drugs_list": [ - "Measurement with O2C" - ], - "diseases": "['Proximal Humeral Fractures']", - "diseases_list": [ - "Proximal Humeral Fractures" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n traumatic fractures of the proximal humerus \n\n surgical treatment \n\n over eighteen years of age \n\n ", - "exclusion_criteria": ": \n\n pathological fractures \n\n conservative treatment \n\n soft tissue damage \n\n delay of surgery more than three days \n\n immunological defects \n\n multiple trauma", - "brief_summary": "This study examines the microcirculation of the caput humeri after proximal humeral fracturation using O2C light probes.~During the operation the blood circulation is measured at four points (tuberculum majus, tuberculum minus, neck and head of the humerus) directly on the bone. The O2C light probes are a none-invasive technique of measuring blood flow, velocity and oxygen concentration. The data is analysed in respect to the fracture type according to the classification of Neer.~Valuable additional information for the correct treatment and prognosis of humeral fractures is expected.", - "NCTID": "NCT01737385" - }, - { - "brief_title": "Feasibility Study of Balloon Kyphoplasty in Traumatic Vertebral Fractures Needing Surgical Fixation", - "phase": "Phase 4", - "drugs": "['balloon kyphoplasty']", - "drugs_list": [ - "balloon kyphoplasty" - ], - "diseases": "['One or Two Traumatic Vertebral Fractures', 'Located Between T11 and L5', 'Balloon Kyphoplasty']", - "diseases_list": [ - "One or Two Traumatic Vertebral Fractures", - "Located Between T11 and L5", - "Balloon Kyphoplasty" - ], - "enrollment": "17.0", - "inclusion_criteria": "inclusion criteria: \n\n Preliminary clinical examination (the anaesthesist must have provided his approval for the surgical procedure) \n\n Patient must have signed the consent form \n\n Male or female patient aged 18 or over \n\n One or two traumatic vertebral fractures located between T11 and L5 and type A3.2, A3.3, B1 or C1 in the MAGERL classification, and with a regional kyphotic angle > 15\u00b0 and treated by osteosynthesis through a posterior surgical approach with or without spinal decompression \n\n Fracture with or without neurological difficulties \n\n Non tumoral origin: Confirmed by biopsy at the same time of the Balloon Kyphoplasty procedure. \n\n ", - "exclusion_criteria": ": \n\n Non- traumatic, malignant or osteoporotic vertebral fractures \n\n History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain. \n\n Known allergy to a contrast media or to one of the cement components used for kyphoplasty. \n\n More than two recent vertebral fractures \n\n Current infection \n\n Impossibility to perform the percutaneous approach of the vertebra to treat. \n\n Reduction by more than 50% of the anteroposterior width of the bony spinal canal due to the vertebral fracture to treat. \n\n Vertebral fracture with loss of 90%or more of the vertebral body height \n\n Patient presenting a non correctable spontaneous or therapeutic coagulation disorder. \n\n Evolutive cardiac disease nonreactive to medical treatment \n\n Non compliant patient: Impossibility to participate to the study and to be followed up for 1 year. \n\n Pregnant or breast feeding women \n\n Patient not affiliated to social security", - "brief_summary": "Some unstable traumatic vertebral fractures (types A3.2, A3.3, B1 et C1 according to MAGERL classification) may undergo unpredictable secondary displacement. Such fractures require a two session surgery with a first operation carried out immediately to achieve posterior fixation and a second surgery which is performed some days later to stabilize the anterior spine and restore stress resistance.~Goal of the present study is to show that percutaneous Balloon Kyphoplasty is able to restore anterior spine strength and replace second session surgery.", - "NCTID": "NCT00749229" - }, - { - "brief_title": "Comparison of Balloon Kyphoplasty and Vertebroplasty in Subacute Osteoporotic Vertebral Fractures", - "phase": "Phase 4", - "drugs": "['balloon kyphoplasty', 'vertebroplasty']", - "drugs_list": [ - "balloon kyphoplasty", - "vertebroplasty" - ], - "diseases": "['Osteoporotic Vertebral Fracture', 'Between T5 and L5', 'Chronic Arthritis, Longer Than Six Weeks Duration']", - "diseases_list": [ - "Osteoporotic Vertebral Fracture", - "Between T5 and L5", - "Chronic Arthritis", - "Longer Than Six Weeks Duration" - ], - "enrollment": "97.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient is able to undergo the vertebroplasty or Balloon kyphoplasty procedure \n\n Patient has read and sign the informed consent \n\n Male or female, 50 years or older \n\n One or two non-traumatic vertebral fracture(s): \n\n Of osteoporotic origin (low speed trauma such as fall from his own height or less than 80 cm) \n\n Fracture(s) older than 6 weeks duration after the onset of pain related to the fracture\u00b7 The fracture(s) exhibit(s) high signal intensity on T2-weighted images and a benign appearance at MRI \n\n Persistent pain despite medical treatment according to VAS \u2265 5 or a last resort to morphine treatment \n\n The patient will be able to receive the selected protocol treatment within 15 days after treatment randomization. \n\n The benign nature of the vertebral fracture has to be confirmed by the results of the biopsy performed during vertebroplasty or balloon kyphoplasty. \n\n ", - "exclusion_criteria": ": \n\n Patient with a vertebral fracture of less than 6 week duration after onset of fracture-related symptoms. \n\n Neurological signs related to the vertebral fracture to treat \n\n History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain. \n\n Patient with more than 2 fractures corresponding to the inclusion criteria (old fractures are not taken into account) \n\n Known allergy to a contrast media or to one of the cement components used for kyphoplasty. \n\n More than two recent vertebral fractures \n\n Current infection \n\n Impossibility to perform the percutaneous approach of the vertebra to treat. \n\n Known allergy to a contrast media or to one of the cement components used for kyphoplasty. \n\n Reduction by more than 50% of the anteroposterior width of the bony spinal canal due to the vertebral fracture to treat. \n\n Vertebral fracture with loss of 90%or more of the vertebral body height \n\n Malignant and traumatic vertebral fractures \n\n Contraindication to MRI : \n\n Metallic implant : pace-maker, no auditive implant , metallic vascular or movable cardiac device \n\n Metallic surgical clips Claustrophobia \n\n Evolutive cardiac disease nonreactive to medical treatment \n\n Patient presenting a non correctable spontaneous or therapeutic coagulation disorder. \n\n Presence of an unexplained biological inflammatory syndrome with VS\u226520 \n\n Non compliant patient: Impossibility to participate to the study and to be followed up for 1 year. \n\n Pregnant or breast feeding women \n\n Patient not affiliated to social security", - "brief_summary": "This study aims to compare two treatments in subacute (more than 6 week duration) non-traumatic (usually osteoporotic) vertebral fractures. The two treatments are the following:~Vertebroplasty consisting in the percutaneous injection into the fractured vertebra of polymethylmetacrylate cement (the cement used to fix prosthesis in joint replacement) through a posterior route through the vertebral pedicles under radiological guidance.~Balloon Kyphoplasty which consists of placing through a percutaneous posterior approach under radiological guidance, into the fractured vertebra a balloon which is inflated with fluid and creates a cavity. This may restore part of the vertebral height loss due to the fracture. In addition, after balloon deflation, polymethylmetacrylate cement is injected with low pressure into the created cavity to fix fracture reduction. The study will indicate if balloon kyphoplasty is able to restore vertebral height of the fractured vertebra better than vertebroplasty.", - "NCTID": "NCT00749086" - }, - { - "brief_title": "Safety in Seconds 2.0: An App to Increase Car Seat Use", - "phase": "", - "drugs": "['Parent Action Report', 'Parent Portal']", - "drugs_list": [ - "Parent Action Report", - "Parent Portal" - ], - "diseases": "['Injuries']", - "diseases_list": [ - "Injuries" - ], - "enrollment": "1129.0", - "inclusion_criteria": "inclusion criteria: \n\n Visiting the Pediatric Emergency Department (PED) at Johns Hopkins Hospital or Arkansas Children's Hospital \n\n Parent or guardian of child 4-7 years \n\n English speaking \n\n Have and Android or iPhone smartphone \n\n Drive with the child in a car at least once per week in a car that the parent owns, borrows or gets a ride round-trip \n\n Resident of Baltimore City, MD or Little Rock, AR and surrounding area. \n\n ", - "exclusion_criteria": ": \n\n PED has flagged case as suspected abuse \n\n Another household member is enrolled in the study \n\n In Arkansas, less than 18 years without parent present at the PED", - "brief_summary": "This project will utilize the first web-based program to provide tailored injury prevention education. The existing Safety in Seconds program was adapted into a smartphone platform. Parents are recruited from and engage in the program in the clinical setting (PED or PTS). Parents download the app onto their smartphone which is used to ask the questions, collect a parent's responses, assess the parents' safety needs and give tailored directions for proper car sear use. The control group parents will also engage with the smartphone app and receive immediate feedback. However, they will receive tailored educational messages about smoke alarms. Parents will also have access to the online SIS v 2.0 Parent Portal which will have educational features (e.g., tips for keeping children content in their CSSs, links to helpful websites). The investigators will use emerging technology such as push notification and email to remind parents to visit the portal and have their child's car seat reassessed.~The investigators plan to conduct a cost benefit analysis of the program's expected financial benefit from the perspective of a third party payer of medical claims and an in-depth examination of program adoption and implementation using qualitative data collected from key informant interviews, direct observations of the clinic environments, and document review.", - "NCTID": "NCT02345941" - }, - { - "brief_title": "Correlation of Location of Abdominal Tenderness With Acute CT Abnormalities in Emergency Department Patients", - "phase": "", - "drugs": "['radio-opaque adhesive skin markers']", - "drugs_list": [ - "radio-opaque adhesive skin markers" - ], - "diseases": "['Abdominal Pain']", - "diseases_list": [ - "Abdominal Pain" - ], - "enrollment": "102.0", - "inclusion_criteria": "inclusion criteria: \n\n All consecutive emergency department patients undergoing abdominal CT for non-traumatic abdominal pain and tenderness will be prospectively enrolled, with the following exceptions. For study purposes, abdominal pain and tenderness is defined as pain and tenderness to direct palpation in the region anterior to the mid-axillary line bilaterally, and extending from the costal margins to the inguinal ligaments. Consequently, patients undergoing CT for indications such as isolated vomiting, fever without source, staging of malignancies, isolated flank pain or suspected renal colic, or other indications that do not meet the above definition will not be enrolled. \n\n ", - "exclusion_criteria": ": \n\n Pregnant women do not routinely undergo abdominal CT due to radiation concerns and will be excluded from the study. \n\n Patients with altered mental status or altered abdominal sensation (due to neurological conditions such as paraplegia) that may prevent assessment of the location of abdominal tenderness will be excluded. \n\n Preverbal children will be excluded as they rarely undergo CT and will be unable to indicate the region of maximal tenderness.", - "brief_summary": "To determine the correlation between the region of abdominal tenderness determined by the examining physician and the location of acute pathology diagnosed on abdominal CT. We hypothesize that the acute pathology diagnosed by CT will lie within the region marked on the abdominal wall by the examining physician prior to CT.", - "NCTID": "NCT00673374" - }, - { - "brief_title": "Single Shot Versus OnQ Pump in Extremity Fractures", - "phase": "Phase 4", - "drugs": "['Ankle SSB', 'Ankle OnQ', 'DR SSB', 'DR OnQ']", - "drugs_list": [ - "Ankle SSB", - "Ankle OnQ", - "DR SSB", - "DR OnQ" - ], - "diseases": "['Pain', 'Fracture']", - "diseases_list": [ - "Pain", - "Fracture" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients at least 18 years old. \n\n Male or Female \n\n All racial and ethnic groups \n\n Fractures and fracture/dislocations of the foot, ankle, tibia, fibula, elbow, forearm, wrist and hand \n\n Patients who opt for surgical treatment of their fractures. \n\n Patients who consent to be randomized. \n\n Patients who are willing to follow-up for a minimum of 52 weeks. \n\n ", - "exclusion_criteria": ": \n\n Patients younger than 18 years old. \n\n Patients who are on chronic opioids \n\n Patients who abuse opioids \n\n Patients who are unwilling to follow-up for a minimum of 52 weeks. \n\n Neurologic condition that could interfere with pain sensation", - "brief_summary": "Peripheral nerve blocks have been well studied in the literature with generally good results for controlling post operative pain following orthopaedic surgery. Regional anesthesia has many benefits. It provides excellent intraoperative anesthesia and muscle relaxation as well as analgesia that continues into the post-operative period. These regional blocks are also effective in controlling pain in the immediate post-operative period. However, as the block wears off, patients begin experiencing increased pain. Compared to patients treated without regional blocks, these patients will often experience a rebound pain--pain occurring 12-24 hours after surgery that is subjectively worse than that in patients treated without regional blocks. Therefore, the investigators propose to use a continuous infusion of anesthetic in order to provide sustained pain control post-operatively. Preoperatively, patients will be randomized into a single shot peripheral nerve block versus a continuous infusion of peripheral nerve block. Post-operatively, pain will be assessed using the Visual Analogue Scale (1-100) prior to being discharged from PACU. Time to discharge and amount of pain medication taken will be recorded. Patients will be contacted at certain time intervals postoperatively to assess their pain scale and pain medication intake. Patients will be seen for routine post-operative follow-up visits where they will be assessed for satisfaction, pain, residual neurological symptoms, and signs of infection.", - "NCTID": "NCT02280291" - }, - { - "brief_title": "Psychological Treatment for Children Suffering From Post Traumatic Stress Symptoms and Mild Traumatic Brain Injury", - "phase": "", - "drugs": "['Prolonged Exposure Therapy']", - "drugs_list": [ - "Prolonged Exposure Therapy" - ], - "diseases": "['PTSD', 'Traumatic Brain Injury', 'Post Concussive Syndrome']", - "diseases_list": [ - "PTSD", - "Traumatic Brain Injury", - "Post Concussive Syndrome" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n For the whole sample: \n\n Children age 6 to 18 \n\n Language spoken: Hebrew, Arabic \n\n DSM- IV R diagnosis: PTSD \n\n Car accident event within past 3 years \n\n For the m-TBI group: \n\n Any of the following symptoms or experiences occurring during or shortly after the accident: loss of consciousness, dazed, confused, saw stars, headache, dizziness, irritability, memory gap (not remembering injury or injury period), visual loss, abdominal pain]. \n\n Diagnosis of MTBI within 3 years as confirmed by CT/MRI/fMRI. \n\n Glasgow coma scale; GCS<15. \n\n ", - "exclusion_criteria": ": \n\n Children presenting with psychotic symptoms \n\n Children presenting with mental retardation", - "brief_summary": "The purpose of this study is to determine whether Prolonged Exposure Therapy (PE)is effective in the treatment of post-traumatic stress symptoms in children and adolescents with mild traumatic brain injury (m-TBI) due to motor vehicle accident.", - "NCTID": "NCT01315379" - }, - { - "brief_title": "Preventing Chronic Whiplash Pain", - "phase": "Phase 3", - "drugs": "['Behavioral treatments', 'Physical therapy']", - "drugs_list": [ - "Behavioral treatments", - "Physical therapy" - ], - "diseases": "['Whiplash Injuries']", - "diseases_list": [ - "Whiplash Injuries" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Have whiplash injury following a motor vehicle accident in the prior 4 to 10 weeks", - "exclusion_criteria": "", - "brief_summary": "This study is aimed at developing ways to prevent acute pain from becoming chronic pain--specifically, pain associated with whiplash-associated disorders (WADs) from motor vehicle accidents. Research on the development of chronic pain due to musculoskeletal injury suggests that a person's initial emotional reactions, particularly fear of reinjury and subsequent avoidance of activity, contribute significantly to chronic pain and persistent disability. This study will treat people with WADs during the first three months after a motor vehicle accident with a behavioral and physical exercise program designed to encourage activity and discourage continued fear of movement, pain, and disability. The study will compare the effectiveness of two anxiety-reduction treatments to standard care in reducing pain and activity limitations in people with WADs in the 2 to 3 months after motor vehicle accidents.", - "NCTID": "NCT00021476" - }, - { - "brief_title": "Teenage Driving Safety Study: An Emergency Medicine-Trauma Collaborative Study", - "phase": "", - "drugs": "['Education']", - "drugs_list": [ - "Education" - ], - "diseases": "['Trauma']", - "diseases_list": [ - "Trauma" - ], - "enrollment": "3750.0", - "inclusion_criteria": "inclusion criteria: \n\n Teenagers perceived to be students driving near school property. \n\n Teenagers perceived to be of driving age. \n\n Teens in 10th, 11th, and 12th grades attending Phillipsburg, Southern Lehigh, Freedom and Liberty High Schools. \n\n Any driver driving near school property, which is perceived to be older than of high school age. \n\n ", - "exclusion_criteria": ": \n\n Teenagers perceived as non-attendees of the nearby school. \n\n Teenagers perceived not to be of driving age. \n\n Teens not in 10th, 11th, and 12th grades, or not attending Phillipsburg, Southern Lehigh, Freedom and Liberty High Schools. \n\n Any driver who does not meet the above criteria. \n\n -", - "brief_summary": "Teenage driving safety continues to be a major public health issue. Two factors have been found to contribute to a higher teenage driving accident rate than adults: lack of driving experience, and risky behaviors. Insufficient driving experience puts teenagers at a disadvantage in detecting and responding to hazards while driving. Factors contributing to distracted driving (a diversion in the driver's attention from the road) may include: talking or text messaging on a cell phone, applying makeup, having multiple passengers, listening to loud music, eating/drinking, smoking or reading while driving.~This is a prospective study designed to evaluate the effect of an educational program on the risks associated with distracted driving for teenage drivers. The researchers will compare cell phone usage behaviors in Pennsylvania, where no cell phone laws are in place, and New Jersey, where cell phone laws exist, and will educate the beginner driver on the potential dangers associated with driving without a seat belt, substance use, and participating in distracting driving behaviors. Knowledge of state laws will also be assessed.~Objectives~Educate participants on the potential dangers of distracted driving.~Evaluate the impact of the educational program on teenage distracted driving behaviors by obtaining and analyzing information from student surveys, state law quizzes, and anonymous observation, pre, post, and delayed post education.~Quantify distracted driving behavior in teenage driver's attending local area high schools by obtaining and analyzing information from student surveys, state law quizzes, and anonymous observation, pre, post, and delayed post education.~Qualify distracted driving behavior in teenage driver's attending local area high schools by obtaining and analyzing information from student surveys, anonymous observation, and anonymous voicemails, text messages, and/or emails pre, post, and delayed post education.~Qualify distracted driving behavior in adults through anonymous observations near local area high schools.~6. Compare teenage driving behaviors as reported and observed between Pennsylvania and New Jersey.~7. Compare seat belt usage, driving behaviors, and substance use in the study population to the state and national averages pre and post education.~8. Compare averages of student's knowledge of state driving laws pre and post education.", - "NCTID": "NCT01402856" - }, - { - "brief_title": "Safety and Efficacy of Autologous Bone Marrow Stem Cells in Treating Spinal Cord Injury", - "phase": "Phase 1; Phase 2", - "drugs": "['laminectomy', 'Intrathecal']", - "drugs_list": [ - "laminectomy", - "Intrathecal" - ], - "diseases": "['Spinal Cord Injuries']", - "diseases_list": [ - "Spinal Cord Injuries" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria: \n\n Must be able to give voluntary (patients may not be able to write) consent. \n\n Must be able to understand study information provided to him. \n\n Patients with complete spinal cord trans-section: at least post 6 months after spinal cord Injury (in chronic patients), < 2 weeks in acute category and 2-8 weeks in subacute patients. \n\n The level of spinal cord injury must be between C4 and T12(neurological level) \n\n Spinal cord injury categorized in terms of ASIA Impairment scale. \n\n Age should be between 20-55 years \n\n ", - "exclusion_criteria": ": \n\n Mechanical ventilation due to neurological impairment \n\n Multiple level trauma \n\n Undetermined size and location of Spinal Cord injury \n\n Gunshot or other penetrating trauma to the spinal cord \n\n Longitudinal dimension of injury by MRI is greater than 3spinal segments \n\n Associated severe head injury \n\n More than 9cms long bone fracture \n\n Women who are pregnant or lactating \n\n Serious pre-existing medical conditions \n\n Disease or impairment that precludes adequate neurological examination. \n\n Should not have co-morbidities like Diabetes, Systemic Hypertension etc. \n\n Severe co-morbidities/bed sores Tests positive for infectious diseases Deranged Coagulation profile and Hb < 8mg/dl", - "brief_summary": "The projected data related to the burden of spinal cord injuries induced limb paralysis in India is quite alarming. This is attributed to the rapid industrialization and economical development in the country. Increase in vehicular traffic has caused numerous road traffic accidents. Rapid increase in populations, development in the computer technology and real estate business lead to construction of huge buildings which indirectly adds to the injuries due to fall. Spinal cord injuries could not be treated adequately with the prevailing treatment modalities. In view of this, there is definitely an urgent need for finding different methods of treatment for these patients who cannot undergo established modalities of treatment or these have been tried unsuccessfully. Since a large number of these patients will loose their productive life and at the prime of their lives, one such alternate therapy, which seems to offer some promise, is stem cell therapy, which has been well studied and published in prestigious journals.~In our present study, we want to evaluate the safety and efficacy of autologous bone marrow derived stem cells surgically transplanted directly into the lesion site with glial scar resection for 8 indian patients of chronic spinal cord injury and intra-thecal injection for 4 indian patients of acute and subacute injury.", - "NCTID": "NCT01186679" - }, - { - "brief_title": "Association Between Low Cortisol Levels and Whiplash Syndrome", - "phase": "Phase 2", - "drugs": "['Hydrocortisone', 'normal saline 0.9%']", - "drugs_list": [ - "Hydrocortisone", - "normal saline 0.9%" - ], - "diseases": "['Injuries, Whiplash']", - "diseases_list": [ - "Injuries", - "Whiplash" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria: \n\n victims of motor vehicle accidents \n\n signed informed consent \n\n ", - "exclusion_criteria": ": \n\n pregnancy \n\n traumatic brain injury \n\n psychiatry disorders \n\n active cancerous conditions \n\n adrenal diseases \n\n medical treatment by estrogens, anti-depressants, melatonin, pain control. \n\n substance abuse \n\n hospitalization due to the trauma \n\n contra indication to hydrocortisone treatment \n\n over 6 hours from time of injury", - "brief_summary": "The investigators hypothesis is that low (or low relatively to the situation) cortisol levels might be a causative factor of whiplash injury or post traumatic stress disorder following road accidents. In this study the investigators enroll patients who sustained a road accident. From all patients a blood sample will be withdrawn to measure cortisol concentrations. Than, the patients will be divided into 2 groups: the study group will receive a single injection of intravenous Hydrocortisone 100 milligram (a synthetic steroid used routinely for many years). The control group will receive a same volume of normal saline which would be used as a placebo treatment. The investigators assume that patients with low cortisol levels would tend to have a higher incidence of whiplash injuries and / or post traumatic stress disorders, and that a single bolus of hydrocortisone may prevent these untoward sequelas of trauma.", - "NCTID": "NCT02090309" - }, - { - "brief_title": "Peripheral Nerve Block Anaesthesia for Ankle Fracture Surgery - an Exploratory Study: Is Rebound Pain a Problem?", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Postoperative Pain']", - "diseases_list": [ - "Postoperative Pain" - ], - "enrollment": "21.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients >= 18 years old scheduled for internal fixation of an ankle fracture as defined above. \n\n Ability to read and understand Danish and give informed oral and written consent \n\n ", - "exclusion_criteria": ": \n\n Multitrauma patients / other simultaneous fractures \n\n Cognitive or psychiatric dysfunction causing expected inability to comply with study protocol \n\n CAVE nonsteroidal antiinflammatory drugs (NSAID) or Morphine or Local Anaesthetics as evaluated by anesthesiologist for any reason \n\n Primary investigator unavailable for PNB administration at scheduled time of operation \n\n Infection at PNB injection site \n\n Time from fracture to operation > 5 days \n\n Existing neuropathy with functional impairment of the fractured extremity \n\n Bodyweight < 50 kg \n\n Daily use of opioids > 2 weeks preoperatively \n\n Pregnancy \n\n Nephropathy requiring dialysis", - "brief_summary": "The purpose of this exploratory study is to characterize the postoperative pain profile of patients undergoing operation with internal fixation of an ankle fracture under nerve block anaesthesia. Special attention is payed towards the possible existence and clinical relevance of a rebound pain phenomenon upon cessation of the nerve block.~Results are used to guide the set up of a randomized controlled trial on the subject.", - "NCTID": "NCT02100098" - }, - { - "brief_title": "Inflammatory Response Following Intraarticular Fracture", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Intraarticular Fracture and Post-traumatic Osteoarthritis']", - "diseases_list": [ - "Intraarticular Fracture and Post-traumatic Osteoarthritis" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years of age or older \n\n Radiographic evidence of tibial plateau fracture \n\n ", - "exclusion_criteria": ": \n\n Less than 18 years of age \n\n Greater than 60 years of age \n\n Any history of pre-existing knee osteoarthritis based on previous diagnosis or suggestive history \n\n Any history of autoimmune disease \n\n Any history of contralateral intra-articular knee injury", - "brief_summary": "The purpose of the study is to investigate a relationship between the inflammatory response following intraarticular fracture and post-traumatic osteoarthritis. The investigators plan to evaluate the inflammatory cytokine profile in knee joint synovial fluid and blood serum in patients who sustain an intraarticular tibial plateau fracture and ankle joint synovial fluid and blood serum in patients who sustain an intraarticular tibial plafond fracture. This information will be combined with radiographs and patient outcome measures to determine a correlation between intraarticular inflammatory response and post-traumatic osteoarthritis.", - "NCTID": "NCT01514643" - }, - { - "brief_title": "AbStats at the Bedside: Improving Patient Feeding Decisions Using an Abdominal Acoustic Score", - "phase": "", - "drugs": "['Abdominal acoustic measurement']", - "drugs_list": [ - "Abdominal acoustic measurement" - ], - "diseases": "['Fasting', 'Diet', 'Biosensing Techniques']", - "diseases_list": [ - "Fasting", - "Diet", - "Biosensing Techniques" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Awake and alert \n\n Not on a regular diet \n\n No mild to moderate acute pancreatitis \n\n No obstructed bowel not amenable to feeding tube placement beyond the obstruction \n\n No massive GI hemorrhage \n\n No impending or established toxic megacolon \n\n No colonic perforation \n\n No severe dysmotility making enteral feeding not possible \n\n No high output intestinal fistula \n\n Able to access the gut for enteral feeding \n\n No abdominal compartment syndrome \n\n No withdrawal of care/DNAR status \n\n No evidence of severe or prolonged ileus \n\n No hemodynamic compromise (MAP <60) requiring high dose vasopressors alone or in combination with large volume fluid or blood product resuscitation to maintain cellular perfusion \n\n No diffuse peritonitis \n\n No intractable vomiting \n\n Not pregnant \n\n At least 18 years of age \n\n ", - "exclusion_criteria": ": \n\n Not awake and alert \n\n On regular diet \n\n Mild to moderate acute pancreatitis \n\n Obstructed bowel not amenable to feeding tube placement beyond the obstruction \n\n Massive GI hemorrhage \n\n Impending or established toxic megacolon \n\n Bowel perforation \n\n Severe dysmotility making enteral feeding impossible \n\n High output intestinal fistula \n\n Unable to access the gut for enteral feeding \n\n Abdominal compartment syndrome \n\n Withdrawal of care/DNAR status \n\n Severe ileus with NG output >1200 ml/d or gastric residual volumes >400 with additional signs of intolerance including absence of bowel sounds, abdominal distention, presence of air/fluid levels on abdominal radiographs \n\n Hemodynamic compromise (MAP <60) requiring high dose vasopressors alone or in combination with large volume fluid or blood product resuscitation to maintain cellular perfusion \n\n Diffuse peritonitis \n\n Intractable vomiting \n\n Pregnant women \n\n Under 18 years of age", - "brief_summary": "This study is being conducted to determine whether providers who have access to their patients' acoustic intestinal rate score as calculated by an abdominal acoustic sensor that continuously monitors bowel sounds (AbStats) will be more likely to advance their patients' diets to a solid diet sooner than those who do not have access to this rate. AbStats calculates intestinal rates by using two small sensors placed on a patient's abdomen to measure and analyze their abdominal sounds.~Patients will be asked to wear a sensor every morning for 20 minutes while they are fasting daily during their inpatient visit. The sensor will measure the sounds within their abdomen. This data will be interpreted by the AbStats device, which will provide an intestinal rate measurement based on the sounds recorded by the sensors.~This intestinal rate will be provided to the patient's treating physician together with other vital signs. The doctor, at his/her discretion, may choose to use this information to make decisions about the patient's feeding status.", - "NCTID": "NCT02396446" - }, - { - "brief_title": "Prevention of Orthostatic Hypotension With Electric Stimulation in Persons With Acute SCI", - "phase": "", - "drugs": "['ES of the abdominal muscles', 'ES of the limb muscles', 'ES of limbs & abdomen']", - "drugs_list": [ - "ES of the abdominal muscles", - "ES of the limb muscles", - "ES of limbs & abdomen" - ], - "diseases": "['Spinal Cord Injury', 'Orthostatic Hypotension']", - "diseases_list": [ - "Spinal Cord Injury", - "Orthostatic Hypotension" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n inpatients \n\n positive diagnosis of OH \n\n acute traumatic SCI \n\n lesion level above T6 \n\n AIS A, B or C \n\n ", - "exclusion_criteria": ": \n\n fractures of the lower limbs \n\n decubitus (NPUAP >2) \n\n massive psychiatric dysfunction \n\n suicide intention", - "brief_summary": "Background:~The presence of orthostatic hypotension (OH) as a consequence of blood volume redistribution during verticalisation in persons with spinal cord injury (SCI) is a common condition.~Aims:~To investigate the impact of three different types of electric stimulation (ES) (ES of the abdominal muscles versus ES of lower limb muscles versus simultaneously ES of abdominal and lower limb muscles versus control) on blood pressure stabilization and verticalisation-degrees between 0\u00b0 and 70\u00b0. The hypothesis is, that the ES-induced contractions of the muscles cause a stabilisation respectively an increase of the blood pressure during the tilt-table test.~Subjects:~20 Women and men, at least 18 years of age, following an acute and traumatic SCI, with a lesion level above T6, an American Spinal Injury Association (AIS) Impairment Scale A,B or C and a diagnosis of OH (by tilt table test) were eligible for the study.~Methods:~Each patient underwent randomly three different types of ES sessions while being positioned on a tilt-table. The following sessions were planned:~A) ES of the abdominal muscles B) ES of the lower limb muscles C) Combination of A and B D) Control session (=diagnostic session)~Study type: Intervention Design: Prospective interventional study", - "NCTID": "NCT01891110" - }, - { - "brief_title": "Examining Written Disclosure as a Treatment for Post-Traumatic Stress Disorder", - "phase": "", - "drugs": "['Written Disclosure']", - "drugs_list": [ - "Written Disclosure" - ], - "diseases": "['Post-Traumatic Stress Disorder']", - "diseases_list": [ - "Post-Traumatic Stress Disorder" - ], - "enrollment": "48.0", - "inclusion_criteria": "inclusion criteria: \n\n Primary diagnosis of post-traumatic stress disorder \n\n Involved in motor vehicle accident that occurred at least 3 months ago \n\n ", - "exclusion_criteria": ": \n\n Current diagnosis of mania, hypomania, bipolar depression, psychotic disorder, substance abuse disorder, or severe depression \n\n History of psychosis \n\n Active suicidality or history of two or more suicide gestures or attempts in the past year \n\n Significant cognitive impairment \n\n Current participation in a psychosocial treatment, such as individual or group therapy led by a clinician", - "brief_summary": "This study will test the effectiveness of writing about a traumatic incident to treat post-traumatic stress disorder in people who have been in car accidents.", - "NCTID": "NCT00862498" - }, - { - "brief_title": "Maastricht Neck Study: Cervical Range of Motion in Whiplash Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Whiplash Injuries']", - "diseases_list": [ - "Whiplash Injuries" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients have had a measurement of the cervical range of motion. \n\n ", - "exclusion_criteria": ": \n\n None.", - "brief_summary": "Rationale: Neck complaints are often caused by motor vehicle accidents and particular after rear-end collision. Patients complain about neck pain after a whiplash trauma, which lead to mobility restrictions of the cervical spine. It is estimated that 20% develop a chronic pain disorder after 1 year, called a chronic whiplash syndrome.~Objective: the primary objective is to investigate the natural course of active-and passive range of motion and principally the difference score between active-and passive cervical range of motion after a whiplash trauma. The secondary objectives are: investigate the predictive value of active-and passive range of motion and chronicity. Further, the correlation between the degree of restriction of the active and passive backward flexion and chronicity will be investigated. Finally, the correlation between the possible predictive factors such as pain, ideas and feeling about pain, memory and attention, events of the last year and complaints after the motor vehicle accident and chronicity are examined.~Study design and study population: a prospective cohort of 100 whiplash patients which underwent a measurement of the cervical movements and gave permission to recontact them for further research.", - "NCTID": "NCT00952510" - }, - { - "brief_title": "Therapy of Complicated Intra-Abdominal Infections With Moxifloxacin or Ertapenem", - "phase": "Phase 3", - "drugs": "['Moxifloxacin (Avelox, BAY12-8039)', 'Ertapenem intravenous']", - "drugs_list": [ - "Moxifloxacin (Avelox", - "BAY12-8039)", - "Ertapenem intravenous" - ], - "diseases": "['Infection']", - "diseases_list": [ - "Infection" - ], - "enrollment": "804.0", - "inclusion_criteria": "inclusion criteria: \n\n Hospitalized men or women >/=18 years of age \n\n Expected duration of treatment with intravenous antibiotics anticipated to be >/= 5 full days but not exceeding 14 days \n\n Ability to provide documented and signed written informed consent \n\n Confirmed or suspected intra abdominal infection defined as follows: \n\n For a confirmed intra abdominal infection, a surgical procedure (laparotomy or laparoscopy) must have been performed within 24 hours prior to enrollment and reveal at least one of the following: \n\n Gross peritoneal inflammation with purulent exudates (i.e. peritonitis) \n\n Intra abdominal abscess \n\n Macroscopic intestinal perforation with localized or diffuse peritonitis \n\n Subjects enrolled on the basis of a suspected intra abdominal infection must have: \n\n Radiological evidence [abdominal plain films, computed tomography (CT), magnetic resonance imaging (MRI) or ultrasound] of gastrointestinal perforation or intra-abdominal abscess and the following signs and symptoms: \n\n Symptoms referable to the abdominal cavity (e.g. anorexia, nausea, vomiting or pain), lasting for at least 24 hours \n\n Tenderness (with or without rebound), involuntary guarding, absent or diminished bowel sounds, or abdominal wall rigidity \n\n At least two of the following SIRS criteria: \n\n Temperature > 38.0\u00b0C rectal or tympanic membrane, or temperature < 36.0\u00b0C rectal or tympanic \n\n Heart rate > 90/min \n\n Respiratory rate > 20/min \n\n WBC >12,000 cells/mm3 or < 4,000 cells/ mm3 \n\n The subject must be scheduled for a surgical procedure (laparotomy or laparoscopy) within 24 hours of enrollment of the study \n\n ", - "exclusion_criteria": ": \n\n Known hypersensitivity to quinolones, and/or to carbapenems and/or to any other type of beta lactam antibiotic drugs (e.g. penicillins or cephalosporins), or any of the excipients \n\n Women who are pregnant or lactating or in whom pregnancy cannot be excluded \n\n History of tendon disease/disorder related to quinolone treatment \n\n Known congenital or documented acquired QT prolongation; uncorrected hypokalemia; clinically relevant bradycardia; clinically relevant heart failure with reduced left ventricular ejection fraction; previous history of symptomatic arrhythmias \n\n Concomitant use of any of the following drugs, reported to increase the QT interval: antiarrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide) or antiarrhythmics class III (e.g., amiodarone, sotalol, dofetilide, ibutilide), neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressive agents, certain antimicrobials (sparfloxacin, erythromycin IV, pentamidine, antimalarials, particularly halofantrine), certain antihistaminics (terfenadine, astemizole, mizolastine), and others (cisapride, vincamine IV, bepridil, diphemanil) \n\n Known severe end stage liver disease \n\n Creatinine clearance 15 mg/day of systemic prednisone or equivalent) \n\n Subjects known to have AIDS (CD4 count < 200/mL) or HIV seropositives who are receiving HAART (HIV positive subjects may be included. HIV testing is not required for this study protocol) \n\n Subjects with a malignant or pre malignant hematological condition, including Hodgkin's disease and non-Hodgkin lymphoma (subjects with solid tumor can be included in the study) \n\n Subjects with a Body Mass Index >/= 45 kg/m2 \n\n Previous enrollment in this study \n\n Participation in any clinical investigational drug study within the previous 4 weeks", - "brief_summary": "A study to compare the safety and efficacy of moxifloxacin to ertapenem in patients with intra-abdominal infections.", - "NCTID": "NCT00492726" - }, - { - "brief_title": "Diagnostic Accuracy of Emergency Physician Performed Bedside Ultrasound in Suspected Acute Appendicitis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Acute Abdomen', 'Acute Appendicitis']", - "diseases_list": [ - "Acute Abdomen", - "Acute Appendicitis" - ], - "enrollment": "250.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient presented with the complaint of right lower abdominal pain \n\n Suspected acute appendicitis \n\n ", - "exclusion_criteria": ": \n\n Flank pain \n\n Previous appendectomy \n\n Pregnancy \n\n Unstable vital signs \n\n Frank peritonitis \n\n US performed before EP's examination", - "brief_summary": "The aim of the study is to evaluate the diagnostic yield and accuracy of bedside emergency physician performed ultrasound in the diagnosis of acute appendicitis.", - "NCTID": "NCT02467959" - }, - { - "brief_title": "Safety Skills Training: Parents of School-Aged Children", - "phase": "Phase 2", - "drugs": "['Am Academy of Pediatrics print materials', 'Family safety 1-2-3']", - "drugs_list": [ - "Am Academy of Pediatrics print materials", - "Family safety 1-2-3" - ], - "diseases": "['Injuries']", - "diseases_list": [ - "Injuries" - ], - "enrollment": "175.0", - "inclusion_criteria": "inclusion criteria: \n\n The basic lower age limit for parents or guardians of children aged 6-11 for this study was 18. Parents or legal guardians could potentially be as old as 65 or older. \n\n ", - "exclusion_criteria": ": \n\n Only English-speaking participants were accepted because the program was developed only for English speakers. All English-speaking parents or guardians living in the U.S., with children aged 6-11 years old, who wished to participate were included. Parents under 18 were excluded from this online study because parental consent cannot be obtained online.", - "brief_summary": "Injuries are the leading cause of death and disability in children in America. Most injuries can be prevented when parents implement effective child safety practices. This project will create a behaviorally based program to teach parents what to do to prevent injuries to their school aged child, in an effort to reduce the number of injuries, hospitalizations, medical costs, and missed work days.", - "NCTID": "NCT02329340" - }, - { - "brief_title": "ED Intervention to Reduce Risky Behaviors in Drivers", - "phase": "Phase 2", - "drugs": "['Brief intervention']", - "drugs_list": [ - "Brief intervention" - ], - "diseases": "['Alcohol Use']", - "diseases_list": [ - "Alcohol Use" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Screen Positive for a drinking problem in the ED \n\n ", - "exclusion_criteria": ": \n\n <18years or >44years old", - "brief_summary": "Disability and death from injury remain a persistent problem in the U.S. and risk-taking behaviors are known to contribute to injury. Healthy People 2010 set goals to reduce deaths caused by injury: Motor vehicle crashes are often predictable and preventable. Increased use of seat belts and reductions in driving while impaired are two of the most effective means to reduce the risk of death and serious injury of occupants in motor vehicle crashes. One preventive strategy is to establish screening and intervention procedures that can be administered in the ED to young adults who have risky driving practices and problem drinking. Goal: The specific aim of this prospective, randomized controlled trial is to test the effectiveness of a brief intervention to limit risky driving behaviors (risky driving practices, lack of seat belt compliance) and problem drinking in drivers during an ED visit. In addition, the trial will result in a benefit-cost analysis from the perspectives of both society as a whole and hospitals in particular. Methods: Young adults 18 to 44 years will be screened for problem drinking and risky driving practices during an ED visit. Subjects who screen positive for problem drinking and risky driving will be randomized to one of three groups: No Contact Control Group (NCG: after informed consent, subjects receive no screening or intervention until 12 months after injury). Contact Control Group (CCG: subjects screened at baseline and every three months for 12 months but no intervention), and a Brief Intervention Group (BIG: subjects receive screening and brief intervention with data collection points every three months for 12 months). A total of 133 subjects per group (N=400) will be enrolled. The intervention will consist of a 20 minute nurse visit in the ED and a booster intervention at 7-10 days after ED discharge. All subjects will be telephoned at 3, 6, 9, and 12 months by interviewers blinded to condition. Outcomes of interest include reported alcohol use, risky driving behaviors, driving citations, adverse health outcomes, and costs (health care utilization, property damage, travel delays, lost work productivity, criminal justice expenses, and monetarized adverse health outcomes). Analysis: Power analysis suggests that 133 subjects in each arm of the trial will have sufficient power to detect a difference of the main outcome variables of interest. A variety of regression techniques, including individual growth curve modeling and event history analysis, will be used to test the proposed hypotheses.", - "NCTID": "NCT00164294" - }, - { - "brief_title": "Q-collar and Brain Injury Biomarkers", - "phase": "", - "drugs": "['Q collar']", - "drugs_list": [ - "Q collar" - ], - "diseases": "['Concussion']", - "diseases_list": [ - "Concussion" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria: \n\n \u2022 Normal healthy volunteer \n\n Able to provide written consent \n\n Must be 14 years or older and a participant on a competitive and organized sports program \n\n Neck circumference of 15 \u00bd - 16 \u00bd inches \n\n ", - "exclusion_criteria": ": \n\n \u2022 Unable to provide written consent \n\n History of neurological deficits, previous cerebral infarction, or severe head trauma \n\n Medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis) \n\n Glaucoma (Narrow Angle or Normal Tension) \n\n Hydrocephalus \n\n Recent penetrating brain trauma (within 6 months) \n\n Known carotid hypersensitivity \n\n Known increased intracranial pressure \n\n Central vein thrombosis \n\n Any known airway obstruction \n\n Any known seizure disorder", - "brief_summary": "Significant morbidity, mortality, and related costs are caused by traumatic brain injury (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the field, designed to mitigate TBI resulting from blast trauma or concussive events, would save lives, and the huge costs currently being experienced for life-treatment of surviving victims. An externally-worn medical device that applies mild jugular compression according to the principle of the Queckenstedt Maneuver (the Device) is being developed by Q30 Labs, LLC (Q30). Initial research suggests that the Device has the potential to reduce the likelihood of TBI. The currently developed collar (Smith 2009; Smith 2011; Smith 2011; Smith 2012) has been approved for studies in humans and the results indicate safety for use during high demand and maximal exertion activities, Study ID: 2013-2240, Institutional Review Board - Federalwide Assurance #00002988). Regarding safety, the externally worn collar is meticulously designed to mimic the body's own omohyoid muscle actions upon the jugular veins that will provide similar pressure and volume increases not to surpass that of a yawn or the mere act of just lying down.~This study will investigate the effectiveness of this device in high school athletes playing a collision or contact sport such as football, hockey, or lacrosse. The high risk sports which utilize helmets during competition will allow for measurements systems to be embedded in the headgear and will not affect play or fit of equipment. Athletes participating in this study will be enrolled into one of two groups 1) device wearing or 2) non-device wearing. By the nature of the sports selected, it is likely this pilot study will primarily include males, however if any female meets inclusion criteria on the team selected they will be included in this pilot investigation. The helmets of all participants will be outfitted with an accelerometer which will measure the magnitude of every impact to the head sustained by the athlete. Effectiveness of the device will be determined by brain imaging during the pre-season, midseason, and end of season time points. A subset of athletes who report a diagnosed concussion will also receive additional brain imaging within the week following the diagnosed concussive event.", - "NCTID": "NCT02271451" - }, - { - "brief_title": "Enhancing ADHD Driving Performance With Stimulant Medication", - "phase": "", - "drugs": "['Methylphenidate Transdermal System']", - "drugs_list": [ - "Methylphenidate Transdermal System" - ], - "diseases": "['Attention Deficit Hyperactivity Disorder']", - "diseases_list": [ - "Attention Deficit Hyperactivity Disorder" - ], - "enrollment": "14.0", - "inclusion_criteria": "inclusion criteria: \n\n ADHD diagnosis \n\n Valid driver's license \n\n Not taking any medication for their ADHD \n\n Have access to a car of which they are the primary driver \n\n Have a history of approximately two driving collisions or citations \n\n Have a history of responsiveness to methylphenidate \n\n ", - "exclusion_criteria": ": \n\n Older than 25 years of age \n\n Bi-polar disease \n\n Psychosis \n\n Satisfy the DSM IV criteria of active depressive or anxiety disorders \n\n Have any medical condition that might impair driving or be contra-indicated for the use of methylphenidate \n\n Pregnant or intending to get pregnant for the duration of the study,breastfeeding or intending to breastfeed for the duration of the study \n\n Have skin allergies or skin condition that could be exacerbated by wearing the medication patch \n\n Have documented allergy, hypersensitivity, or intolerance to methylphenidate \n\n Have documented hypersensitivity to the Daytrana\u00ae adhesive backing \n\n Have (history of): \n\n seizures (except febrile seizure in infancy) \n\n liver or renal disease \n\n glaucoma \n\n chronic skin conditions or contact sensitivities \n\n current symptoms suggestive of cardiac disease \n\n cardiovascular disease, e.g. \n\n structural cardiac abnormalities \n\n cardiac Arrythmias \n\n cardiomyopathy \n\n hypertension \n\n reported ECG abnormality \n\n vocal tics, motor tics, Tourettes Disorder or family history of Tourettes \n\n Have a current diagnosis of \n\n Psychosis \n\n Bi-polar disease \n\n Anxiety disorder \n\n Substance Use Disorder/Substance Abuse Disorder \n\n Substudy: In addition to the above requirements, in order to participate in the substudy, participants must be capable of driving the simulator without experiencing simulation sickness", - "brief_summary": "Among children, attention-deficit/hyperactivity disorder (ADHD) is associated with an increased risk for accidents, especially bicycle and pedestrian (Leibson 2001; Jensen 1988; DiScala 1998). Anywhere from 40% to 80% of children diagnosed with ADHD continue to display symptoms of the disorder into adolescence(Barkley 1990; Gittelman 1985). Adolescents with ADHD are also at an increased risk for driving-related accidents, being 2 to 4 times more likely to experience a motor vehicle accident (Barkley 1993; Barkley 1996; Cox 2000), 4 times as likely to be at fault in the accident (Barkley 1993), and over 3 times more likely to incur associated injuries as a result of the accident(Murphy 1996).~Stimulant treatment with immediate-release methylphenidate (IR MPH) has been demonstrated to improve driving performance in adolescents with ADHD.~Hypothesis to be Tested:~Main study: Just as stimulant medication improves simulation and on-road driving performance of ADHD teenagers, it is hypothesized that stimulant medication will improve routine driving performance.~Substudy - Extended wear (15 hours) of Daytrana will lead to safer driving late in the evening (22:00 and 01:00), when the most dangerous driving mishaps are most likely to occur, and the next morning at 09:00.", - "NCTID": "NCT00572026" - }, - { - "brief_title": "Way to Safety Cellphone Blocking", - "phase": "", - "drugs": "['Cellcontrol DriveID', 'Education Only']", - "drugs_list": [ - "Cellcontrol DriveID", - "Education Only" - ], - "diseases": "['Teen Drivers', 'Motor Vehicle Accident']", - "diseases_list": [ - "Teen Drivers", - "Motor Vehicle Accident" - ], - "enrollment": "35.0", - "inclusion_criteria": "inclusion criteria: \n\n High school student \n\n 16 or 17 at start of the study \n\n Have a valid driver's license \n\n Lives in parent's/guardian's home \n\n Drives to school \n\n Primarily drive one car \n\n Has their own iPhone 4S or newer or Android 4.3 or newer smartphone with data plan \n\n Parent/guardian is willing to assist with installation \n\n Admit to texting while driving >1 time in the last 30 days \n\n ", - "exclusion_criteria": ": \n\n 1. Already uses a smartphone app or hardware device to limit cellphone use while driving", - "brief_summary": "Research participants will be recruited to take part in a randomized control trial. Participants' cellphone use will be observed during an initial baseline period. Participants will then be randomly assigned to one of four conditions: education only (control), opt-in blocking, opt-out blocking, and opt-out blocking with parental notification.", - "NCTID": "NCT02416713" - }, - { - "brief_title": "Lactated Ringer's Solution in Neonates With Feeding Intolerance", - "phase": "Phase 2", - "drugs": "[\"Lactated Ringer's Solution\"]", - "drugs_list": [ - "Lactated Ringer's Solution" - ], - "diseases": "['Intestinal Disease', 'Feeding Disorder Neonatal']", - "diseases_list": [ - "Intestinal Disease", - "Feeding Disorder Neonatal" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Birth gestational age (GA) between 25 and 32 weeks \n\n Corrected gestational age less than 34 weeks \n\n Enteral feeding tolerated at a minimum of 10 ml/kg/day for a minimum of 48 hours \n\n Severe feeding intolerance, defined as a minimum of one or more of the following signs leading to withholding of milk feedings on two evaluations over 12 to 24 hours: \n\n Significant increased abdominal girth, as evaluated by the treatment team, with abdominal tenderness \n\n Visible enlarged bowel loops with abdominal tenderness \n\n Recurrent emesis leading to withhold feeds \n\n Gastric residuals in excess of one feeding, recurrent or with growing abdominal girth \n\n Visible blood in stools without anal etiology \n\n Documented informed consent for participation in the study \n\n ", - "exclusion_criteria": ": \n\n Infants who already reached full enteral feeds for 72 hours, in fact a minimum of 130 ml/kg/day enteral feeds without parenteral supplementation. \n\n Small for gestational age (SGA) (weight at or less than the 3rd percentile on the Fenton growth chart) \n\n NEC (Bell's stage II or higher, radiologic evidence of NEC, pneumatosis intestinalis or free intraperitoneal air)or history of NEC \n\n Gastric or intestinal occlusion (no transit, absent bowel sounds, incessant vomiting, bile stained vomiting or air fluid levels) \n\n Major congenital malformation \n\n Septic infants requiring therapeutic antibiotics or antimycotics (infants only on prophylactic antibiotics or antimycotics should not be excluded). \n\n Patients judged as being too ill to enroll in this study, as defined by a requirement for mechanical ventilation with >50% FIO2 \n\n Patent Ductus Arteriosus requiring ibuprofen, indomethacin or ligature, until one week after the end of treatment \n\n Intraventricular Haemorrhage grade 3 or 4 \n\n Hypernatremia \u2265 150 mmol/L", - "brief_summary": "The objective of this study is determining if enteral administration of Lactated Ringer's solution (LR) in preterm infants with feeding intolerance enables for faster advancement of milk feeding than fasting.", - "NCTID": "NCT01236833" - }, - { - "brief_title": "Michigan Driver Education Study", - "phase": "Phase 3", - "drugs": "['Driver Education']", - "drugs_list": [ - "Driver Education" - ], - "diseases": "['Behavioral Intervention']", - "diseases_list": [ - "Behavioral Intervention" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Teens between the ages of 15 years 0 months and 16 years 6 months enrolled in a licensed driver education course are eligible to participate. \n\n ", - "exclusion_criteria": ": \n\n Adolescents over the age of 16 years 6 months or those whose parent or legal guardian does not attend the driver education course session to which they are specifically invited will be deemed ineligible for the study.", - "brief_summary": "Teens are at high risk for traffic violations and car crashes because of their young age, lack of driving experience, and exposure to high-risk driving conditions. The Checkpoints Program has used increased parental restrictions on teen driving through at least the first 4 months after their children obtain a driver's permit.~The purpose of this study is to evaluate the efficacy of the Checkpoints Program.~Approximately 400 teens in Michigan will participate in one of two study groups. One group will take standard driver education classes; the other group will take driver education classes that incorporate the Checkpoints Program. Teens and their parents will complete a written survey after completing the classes and a telephone survey after teens obtain a driver's permit. Teens will complete additional telephone surveys 1, 3, 6, and 12 months after obtaining a driver's permit. Researchers will use this information to study how parents manage teen driving practices, teen driving experiences (amount and conditions of), and high-risk teen driving behaviors.", - "NCTID": "NCT00340470" - }, - { - "brief_title": "Abdomen CT and Open Appendicectomy\uff1aNew Diagnostic and Surgical Procedures", - "phase": "", - "drugs": "['The application of abdomen CT', 'traditional incision']", - "drugs_list": [ - "The application of abdomen CT", - "traditional incision" - ], - "diseases": "['Wound Infection', 'Complication', 'Scar']", - "diseases_list": [ - "Wound Infection", - "Complication", - "Scar" - ], - "enrollment": "730.0", - "inclusion_criteria": "inclusion criteria: \n\n patients with a clinical diagnosis of acute appendicitis \n\n ", - "exclusion_criteria": ": \n\n children under 14 are not included", - "brief_summary": "The traditional open appendectomy in the clinical effect is not prefect, and for a long time there is no measurable improvement. The application of abdomen CT before surgery provides a new approach to the incision and new perception.~In a randomized controlled trial of modified incision versus traditional incision. Length of hospital day was the primary terminus, while operating time, postoperative complication, scar and time to resume normal activity and work as secondary terminus.", - "NCTID": "NCT02574364" - }, - { - "brief_title": "Abdominal Compression Elastic Support (ACES)", - "phase": "", - "drugs": "['Abdominal Compression Elastic Support']", - "drugs_list": [ - "Abdominal Compression Elastic Support" - ], - "diseases": "['Intradialytic Hypotension']", - "diseases_list": [ - "Intradialytic Hypotension" - ], - "enrollment": "13.0", - "inclusion_criteria": "inclusion criteria: \n\n Must be able to give informed consent for participation in this study \n\n Age \u2265 18 years \n\n A body weight > 100 lb or a body mass index > 18.5. \n\n End-stage renal disease with hemodialysis in-center three times per week \n\n Not missing any treatments in the preceding two weeks and in compliance with instructions from the health care provider. \n\n In the last month had at least two episodes of IDH (defined as having hypotensive symptoms such as dizziness, fainting, headache, nausea, vomiting, cramping, weakness, blurry vision and/or a decrease in systolic blood pressure (SBP) of more than 20 mmHg). \n\n Hemoglobin greater than or equal to 9.0 g/dL (hematocrit 27%) to hemoglobin of 15.0 g/dL (hematocrit 45%). \n\n ", - "exclusion_criteria": ": \n\n \u2022 Pregnancy (self-reported) \n\n Allergic to nylon, polyesters and latex. \n\n Not able to understand the English language \n\n Not able to disengage the ACES from compression \n\n Having an excessively low systolic blood pressure (SBP which is less than 90 mmHg) \n\n Hemoglobin less than 9.0 g/dL or greater than 15 g/dL \n\n Excessive intra-abdominal fluid pressure \n\n Respiratory distress \n\n Bleeding in the chest and abdomen \n\n Bleeding dyscrasia causing serious coagulation problem \n\n Raised intra-abdominal pressure \n\n Having the following cardiovascular, pulmonary and abdominal complications: \n\n Systolic congestive heart failure, defined as a systolic ejection fraction of less than 25% \n\n Coronary artery disease defined as having a history of myocardial infarction or hemo-dynamically significant stenosis on cardiac catheterization or acute or chronic angina \n\n Circulatory shock \n\n Head trauma and/or abdominal trauma in the past three months \n\n Mesenteric ischemia \n\n Active foot ulcer \n\n Pulmonary edema \n\n Uncontrolled Hypertension (defined as systolic pressure of 180 mm Hg or a diastolic pressure of 110 mm Hg or higher) - using the average blood pressures obtained at one prior recent dialysis session and the average blood pressures obtained at the screening trial session for ACES. \n\n Liver disease as defined as an elevated ALT, AST, and Alkaline Phosphatase 2.5 times the upper limit of normal on a prior lab from medical records. \n\n INR > 1.5 or use of coumadin \n\n Platelets < 100 \n\n Active infection \n\n The need to use anti-hypotensive drugs on the days the ACES belt is applied. \n\n If the average systolic blood pressure with anti-hypotensive drugs or without and made before hemodialysis treatment is less than 90 mmHg, then the ACES session will be postponed to the next treatment. If similar hypotension situation occurs in the next ACES/hemodialysis treatment, then the subject will be taken out of the ACES trial and be considered a screen fail.", - "brief_summary": "Hemodialysis (HD) patients with end stage renal disease (ESRD) experience higher rates of cardiovascular (CV) morbidity and mortality than do the general population and many populations with other chronic diseases. This exceptional risk is explained in part by known risk factors, such as diabetes, hypertension, and other uremia-related factors, including vascular calcification and stiffness, autonomic dysfunction, and a high burden of circulating inflammatory mediators. Recent studies suggest that blood pressure variability, especially intra-dialytic hypotension (IDH) is the most significant risk factor for these CV events. Studies have also shown that the use of IAB is capable of improving cardiovascular function for avoiding or minimizing the development of an orthostatic hypotensive episode (OHE) in patients with autonomic dysfunction, orthostatic hypotension (OH) in diabetes patients and children with orthostatic intolerance, and post-dialytic orthostatic hypotension (PDOH).~The investigators propose a study to examine the use of an abdominal compression elastic support (ACES) to prevent the development of IDH in patients who are known to be prone to these episodes. The ultimate goal is to facilitate more effective and safer dialysis therapy. The ACES has a configuration that is similar to a back-support work belt or an inflatable abdominal band (IAB). All of these devices are wrapped around to compress the abdomen at the waist.", - "NCTID": "NCT02159625" - }, - { - "brief_title": "Ankle Manual Therapy for Ankle Sprains", - "phase": "Phase 2; Phase 3", - "drugs": "['Passive Positioning', 'High-Velocity, Low-Amplitude Stretch', 'Slow, Mobilization Stretch']", - "drugs_list": [ - "Passive Positioning", - "High-Velocity", - "Low-Amplitude Stretch", - "Slow", - "Mobilization Stretch" - ], - "diseases": "['Sprains and Strains']", - "diseases_list": [ - "Sprains and Strains" - ], - "enrollment": "189.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 16-60 years \n\n Onset of ankle sprain at least 2 weeks prior to enrollment \n\n Foot and Ankle Ability Measure Activity of Daily Living subscale score less than or equal to 80% \n\n ", - "exclusion_criteria": ": \n\n Current status of assisted ambulation (eg, use of cane or crutches) \n\n Inability to bear weight through the affected extremity immediately after injury combined with tenderness to palpation of the medial and lateral malleolar zones, styloid process of the 5th metatarsal, and navicular \n\n Positive anterior drawer or talar tilt dimple test \n\n Volume of the affected limb greater than 10% of the unaffected limb \n\n Previous history of ligament or bony reconstructive surgery to the ankle and foot \n\n Concomitant injury to other lower extremity joints", - "brief_summary": "The purpose of this study is to determine the effect of using ankle manual therapy procedures on clinical outcomes in individuals with post-acute ankle sprains.", - "NCTID": "NCT00888498" - }, - { - "brief_title": "Eldecalcitol for GLucocorticoid Induced OsteopoRosIs Versus Alfacalcidol", - "phase": "", - "drugs": "['Eldecalcitol', 'Alfacalcidol']", - "drugs_list": [ - "Eldecalcitol", - "Alfacalcidol" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "400.0", - "inclusion_criteria": "inclusion criteria: \n\n (1) Patients who are currently taking or plan to take oral glucocorticoid medication for 3 months or longer and thus require treatment as per the 'Guidelines on the management and treatment of glucocorticoid-induced osteoporosis of the Japanese Society for Bone and mineral Research (2004),' and who meet at least one of the conditions below. No restriction is imposed on the underlying disease treated with the oral glucocorticoid medication. \n\n (i) Have any existing insufficiency fracture (ii) %YAM <80 (iii) Oral glucocorticoid daily dose >= 5 mg prednisolone equivalent \n\n (2) Aged between 20 and 85 years (both inclusive) at consent \n\n (3) Patients who are able to walk without assistance \n\n (4) Provided consent to participate in the study \n\n ", - "exclusion_criteria": ": \n\n (1) BMD (L1-4 or T-Hip) T score < -3.5 \n\n (2) Have 3 or more vertebral fractures between L1 and L4. \n\n (3) Have 1 or more SQ grade 3 vertebral fractures, or 3 or more SQ grade 2 vertebral fractures. \n\n (4) Have received a bisphosphonate preparation for 2 weeks or longer within 6 months before the start of study treatment. \n\n (5) Have received a bisphosphonate preparation for 2 years or longer within 3 years before the start of study treatment. \n\n (6) Have received a parathyroid hormone preparation before the start of study treatment. \n\n (7) Have received one or more doses of an anti-RANKL (receptor activator of nuclear factor-kappa B ligand) antibody. \n\n (8) Have received one or more doses of an anti-sclerostin antibody or cathepsin K inhibitor. \n\n (9) Have received any other investigational product (including placebo) within 16 weeks before the start of study treatment in the present study. \n\n (10) Have received any of the following drugs that can affect bone metabolism within 8 weeks before the start of study treatment, with the exception of calcium preparations: (i) Bisphosphonates (ii) Active vitamin D preparations (including those for topical use) (iii) Selective estrogen receptor modulators (SERMs) (iv) Calcitonin preparations (v) Vitamin K2 preparations (vi) Ipriflavone preparations (vii) Reproductive hormone products (except those for vaginal use such as vaginal tablets and creams) (viii) Other drugs that can affect bone metabolism \n\n (11) Pregnant woman or woman who desires to become pregnant \n\n (12) Have corrected serum calcium >= 10.4 mg/dL or < 8.0 mg/dL at enrollment. \n\n (13) Have corrected urinary calcium > 0.4 mg/dL GF at enrollment. \n\n (14) Have a past or current history of urinary calculus. \n\n (15) Have eGFR < 30 mL/min/1.73 m2 at enrollment. \n\n (16) Have severe liver disease such as cirrhosis or severe heart disease such as severe cardiac failure. \n\n (17) Have active malignancy or received treatment for malignancy, including adjuvant therapy, within the past 3 years. \n\n (18) Have a history of hypersensitivity to eldecalcitol, alfacalcidol, or other vitamin D preparations. \n\n (19) Other persons judged by the investigator (or subinvestigator) to be inappropriate to participate in this study.", - "brief_summary": "The purpose of this study is to evaluate the efficacy and safety of eldecalcitol monotherapy compared with alfacalcidol monotherapy in patients with glucocorticoid-induced osteoporosis, using a randomized, open-label, parallel-group, comparative design.", - "NCTID": "NCT01974167" - }, - { - "brief_title": "Electric Stimulation of the Eye to Improve Vision After Trauma", - "phase": "", - "drugs": "['Transcorneal Electrical Stimulation', 'Sham']", - "drugs_list": [ - "Transcorneal Electrical Stimulation", - "Sham" - ], - "diseases": "['Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)', 'Trauma', 'Multiple Sclerosis (MS)']", - "diseases_list": [ - "Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)", - "Trauma", - "Multiple Sclerosis (MS)" - ], - "enrollment": "97.0", - "inclusion_criteria": "inclusion criteria: \n\n You are 18 years or older. \n\n You have sustained trauma (more than 3 months before this study) OR been diagnosed with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) (more than 6 months before this study) OR been diagnosed with Multiple Sclerosis (MS) and suffered visual loss (more than 3 months before this study). \n\n You are willing and able to give written informed consent. \n\n You are able to commit to enrolling in the study during the full time period of up to 6 months. \n\n ", - "exclusion_criteria": ": \n\n You have any other significant ophthalmologic disease or condition (such as glaucoma, retinal degeneration, proliferative diabetic retinopathy, +/- six diopters of myopia, retinal detachment, exudative age-related macular degeneration). \n\n You have amblyopia (lazy eye) in affected eye, previously diagnosed. \n\n You are participating in any other interventional clinical trial. \n\n If you are pregnant OR a woman with childbearing potential who is unwilling to use medically acceptable means of birth control for study duration OR woman unwilling to perform a pregnancy test at study entry/screening. \n\n You are unable to give signed consent due to memory, medical, communication, language, or mental health problems. \n\n You are less than 18 years old. \n\n You are unable or unwilling to complete the evaluation or questionnaire. \n\n Visual acuity better than 20/40 \n\n Inability to detect phosphenes during threshold detection \n\n You are on seizure medications, or have a history of epilepsy.", - "brief_summary": "Transcorneal Electrical Stimulation (TES) using the OkuStim\u00ae device delivers electrical impulses to damaged and/or diseased photoreceptor cells. This electric stimulation of the retina may help to preserve visual acuity and/or the visual field.", - "NCTID": "NCT02019927" - }, - { - "brief_title": "Effect of Experience on Driving Performance in New Teenage Drivers", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Learning']", - "diseases_list": [ - "Learning" - ], - "enrollment": "48.0", - "inclusion_criteria": "inclusion criteria: \n\n Recruitment of teen participants will occur by arrangement with local driving schools in Montgomery County, VA. \n\n Potential participants aged 16 or 17 who have held their driver's license for one month or less may be eligible. \n\n Participants may be recruited during their training, and will only be eligible after they have met all requirements for licensure, and after both parental consent and teen assent are obtained. \n\n If the teen wishes to participate, they must have their parent or legal guardian speak to the VTTI experimenter over the telephone for screening and then accompany the teen at an appointment so that the study can be explained and consent and assent provided. \n\n Experienced adult drivers will be recruited via one-page recruitment fliers describing the study posted in the Blacksburg, VA area. \n\n After an appointment is made, a telephone screening will occur using the Telephone Driver Screening and Demographic Questionnaire to assess age, sex, medical and driving history.", - "exclusion_criteria": "", - "brief_summary": "This study will evaluate the driving performance of new teenage drivers and determine to what extent independent driving experience improves driving performance of young drivers. Motor vehicle crash rates are highest among new teen drivers, especially during the first 6 months and 1,000 miles of independent licensed driving. Crash rates decline with experience, and this study will assess the effect of driving experience on performance.~Newly licensed teenagers ranging from 16 years, 3 months to 17 years of age and experienced drivers 30 to 50 years of age may be eligible for this study. Candidates must be able to legally drive in the commonwealth of Virginia and have at least 20/40 correctable vision.~Participants complete a questionnaire about their health and driving experience. They are then tested on a driving test track. Teens are tested within 3 weeks of obtaining their driver's license and before they have more than 100 miles of independent driving experience. They are tested a second time 6 to 12 months later and after they have more than 1,000 miles of driving experience. A group of experienced adult drivers are also tested to provide a comparison.~The driving test is conducted on a smart road - a controlled, 2.2-mile two-lane research track at the Virginia Tech Transportation Institute. It is designed for safety, with restricted access, nothing for a vehicle to hit, carefully placed guardrails, and other safety features. The research vehicle is equipped with airbags, anti-lock brakes, and other safety equipment. It also has sensors and tiny video cameras to assess the behavior of the vehicle and the driver; this equipment does not interfere with the operation of the vehicle.~An experimenter accompanies the driver and instructs him or her to perform routine driving skills, such as stopping, changing lanes and maintaining speed, as well as to other tasks such as inserting a CD into an entertainment console, having a conversation, and answering a cellular telephone call. The driver has an opportunity to practice the tasks before being tested.~The driver's speed is limited to 35 mph or less during the experiment and the driver is required to wear seat belts and follow safe driving procedures. The experimenter is in the front passenger seat can stop the vehicle using a separate brake pedal.", - "NCTID": "NCT00340561" - }, - { - "brief_title": "Phenytoin and Driving Safety: A Randomized, Controlled Cross-Over Study", - "phase": "Phase 4", - "drugs": "['Phenytoin', 'Placebo oral capsule']", - "drugs_list": [ - "Phenytoin", - "Placebo oral capsule" - ], - "diseases": "['Cognitive Measures', 'Driving Simulator Performance']", - "diseases_list": [ - "Cognitive Measures", - "Driving Simulator Performance" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Anticipating a 10-15% drop-out rate, we will induct 30 neurologically normal subjects (age 18 (21) -60) to obtain 25 evaluable subjects who are legally licensed to drive in their state of residence and have been actively driving under appropriate legal guidelines for at least 5 years (to minimize performance variations of novice drivers). \n\n Because this study is intended to determine the potential effects of phenytoin on driving performance, a relatively healthy cohort of patients must be chosen. Chronic medical or psychiatric conditions could cause significant alterations in driving performance independent of those caused by phenytoin, which would complicate interpretation of performance impairments. \n\n ", - "exclusion_criteria": ": \n\n Subjects who are younger than 18 or older than 60 \n\n Have history of prior seizures, family history of epilepsy, or prior history of head injury \n\n Have a known history of prior drug or alcohol abuse or unwillingness to abstain from drug or alcohol use during the study period \n\n Have a past or current active neurological or psychiatric disorder that could impair cognitive or driving performance (i.e. baseline IQ < 90, dementia, mental retardation, stroke, severe head injury, schizophrenia, active clinical depression, progressive brain tumor). \n\n Subjects who have a chronic medical condition (i.e. diabetes mellitus, renal insufficiency, congestive heart failure, hepatic dysfunction, hematologic condition, HIV) \n\n Taking medications known to affect the central nervous system (i.e. baseline pre-study treatment with antiepileptic drug, anxiolytics, sedatives, hypnotics, antidepressants, antipsychotics, narcotics and tranquilizers) \n\n Regularly use over-the-counter cough suppressants, antihistamines, or sleep aids; or who ingest over 7 cups of daily coffee or currently smoke cigarettes. \n\n Subjects will be excluded if they cannot complete SIREN testing or neuropsychological instruments because of visual or hearing impairment (history or screening discovery of corrected visual acuity of less than 20/50) or other physical disability, or if they have a history of severe motion sickness as an adult-a marker for patients who develop simulator sickness and therefore cannot participate in SIREN testing.", - "brief_summary": "Automobile driving is a crucial aspect of everyday life, yet vehicular crashes represent a serious public health problem. Patients with epilepsy are at elevated risk for automobile crashes, causing great personal suffering and financial costs to society. Most collisions involving epileptic drivers are not seizure related but may instead result from cognitive effects upon driving performance of epilepsy and antiepileptic drugs (AEDs). Several million American drivers take AEDs for treatment of medical conditions besides epilepsy and may also be at risk for cognitive impairments that can reduce driving performance. Empirical evidence of the effects of AEDs on driving performance would enable development of driving guidelines that could lower the risk of injurious motor vehicle collisions; however, this evidence is currently lacking. The broad goal of our project is to determine the specific effects of the most commonly utilized AED, phenytoin, by assessing driving performance and cognitive abilities in neurologically normal volunteers taking phenytoin in a randomized, double-blind, placebo-controlled, crossover study. Our proposed experiments will assess: (1) cognitive functions using standardized neuropsychological tests (of attention, perception, memory, and executive functions), (2) driving performance during phenytoin and placebo administration, and (3) the effects of phenytoin-related cognitive performance upon driving performance. To measure driving performance, we will use a state-of-the-art fixed-base interactive driving simulator that allows us to observe driver errors in an environment that is challenging yet safe for the driver and tester, under conditions of optimal stimulus and response control. The results of this study of 30 drivers treated with phenytoin and placebo will increase the understanding of the role of AED-related cognitive impairment on driving safety errors. A better understanding of the impact of AEDs upon driving performance is necessary to rationally develop interventions that could help prevent crashes by drivers treated with AEDs.", - "NCTID": "NCT00581893" - }, - { - "brief_title": "Driving Simulator Performance After Intake of Zopiclone Sleeping Pills", - "phase": "", - "drugs": "['Zopiclone', 'Ethanol', 'Placebo pill', 'Placebo drink']", - "drugs_list": [ - "Zopiclone", - "Ethanol", - "Placebo pill", - "Placebo drink" - ], - "diseases": "['Automobile Driving']", - "diseases_list": [ - "Automobile Driving" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Male \n\n Caucasian ethnicity \n\n Age 25-35 years \n\n Possession of a driver's licence for at least five years \n\n ", - "exclusion_criteria": ": \n\n Score \u2265 2 on the modified Apfel-scale to assess risk for motion sickness(*) \n\n History of driving under the influence of alcohol and/or illicit substances \n\n History or presence of alcohol or illicit drug abuse \n\n Former abnormal reaction to any hypnotic drug \n\n History of strong averse reactions to blood sampling procedures \n\n Regular (daily) intake of any prescribed drug, or intake of grapefruit juice or herbal remedies that can influence the metabolism of zopiclone (e.g. St John's wort) \n\n History of severe allergic reactions, or significant mental, cardiovascular, renal or hepatic disorder, or other significant disease as judged by the investigators \n\n Detection of any drugs of abuse on pre-session urine drug screening \n\n (*)Modified Apfel-criteria for prediction of postoperative nausea/vomiting: \n\n Smoker? yes 0, no 1 \n\n History of nausea and/or vomiting following surgery, dental treatment, injections or similar procedures? yes 0, no 1 \n\n History of car sickness after 10 years of age? yes 0, no 1 \n\n A score of two or more points excludes participation.", - "brief_summary": "Zopiclone, a widely used hypnotic drug, is frequently found in blood samples taken from drivers suspected of driving under the influence. In this study, the investigators aim to correlate zopiclone serum concentrations with degrees of driving impairment in healthy volunteers by use of a validated driving simulator. The investigators also aim to compare their results with the results from a previous study that investigated zopiclone impairment of cognitive and psychometric tests.", - "NCTID": "NCT01257165" - }, - { - "brief_title": "The Effects of Combining Modified ride-on Cars With Bimanual Training on Enhancing Mobility, Socialization, Motor Function and Participation in Toddlers With Disabilities", - "phase": "", - "drugs": "['Ride-On Cars with Bimanual Training Program (ROCBT)', 'Early Mobility Training Program', 'Regular Therapy Program']", - "drugs_list": [ - "Ride-On Cars with Bimanual Training Program (ROCBT)", - "Early Mobility Training Program", - "Regular Therapy Program" - ], - "diseases": "['Children With Mobility Disabilities']", - "diseases_list": [ - "Children With Mobility Disabilities" - ], - "enrollment": "29.0", - "inclusion_criteria": "inclusion criteria: \n\n motor delays (sd>1.5) resulting in motor impairments that prevented functional independent mobility, such as rolling, crawling, walking; \n\n aged between 12 months to 36 months old \n\n able to tolerate sitting with support for 30 minutes \n\n able to reach the objects with either one or two hands \n\n consent of the parents to agree to the testing procedures and participate in the training program at the hospital. \n\n ", - "exclusion_criteria": ": \n\n children with severe sensory impairments such as blindness, deafness \n\n parents/caregivers are not able to make a time commitment for the training phase", - "brief_summary": "The four purposes of this study are: 1) to examine the feasibility of combining modified ride-on cars with bimanual training (ROCBT) on mobility, socialization and motor function in toddlers with disabilities; 2) to quantify whether toddlers with disabilities are able to have more manual explorations and social interactions with ROCBT through observation and wrist-worn accelerometers; 3) to determine the critical factors of using the modified ride-on toy car on family perceptions and participation.~Independent mobility is believed to be essential for perceptual-motor, cognition, language and social skill development. It is important to increase independent mobility in toddlers with disabilities and further enhance their development, especially socialization. Assistive and power mobility devices allow toddlers with disabilities to move independently within their environment and may increase the opportunities to explore and interact with people and environment. However, issues to consider before prescribing an assistive device include factors such as age, accessibly to community environments, cost, and social acceptance of the device and the adaptability of the device to growth. To address these limitations and meet toddlers' needs, the concept of using modified ride-on toy cars in therapy becomes a novel application. Study has demonstrated the use of toy cars enhanced a child's motivation, socialization and family participation. This study is further to combine the use of customized, modified ride-on toy cars with bimanual training, to enhance the independent mobility, manual exploration and socialization through low-cost, family-centered approach. It will also improve family's understanding of children's capabilities, which improve their development.~Investigators will recruit 75 children with who are between 1 to 3 years old and diagnosed as motor delay (>1.5 sd). They will be randomly assigned to one of the following three groups: ROCBT treatment group, early mobility training group and regular therapy group. The whole study duration will be 18 weeks, including 9-week intervention and 9-week follow-up; the total amount of treatment will be equal for two groups. Standardized assessments are provided for a total of three times during the study, including the time before and after the intervention and in the end of the follow-up phase. The ROCBT and early mobility training programs will be administered by the therapist and include 120 minutes/per session, 2 sessions/per week. The research team will visit the hospital once/per week to provide 60 minutes videotaping and wearing wrist-worn accelerometers. The regular therapy group will continue their regular therapy without any additional car driving training. The research team will visit them once/per week for the assessments. The assessments include standardized measurements and behavior coding from the videotapes and accelerometers. The findings of this study will help to understand the feasibility and effectiveness of combining the low-tech modified ride-on cars with bimanual training on advancing children's mobility and socialization. They can be used in the clinic or school and are a low cost alternative or addition to other mobility devices. They may provide a novel therapeutic tool to improve mobility, socialization, family participation and development.", - "NCTID": "NCT02527499" - }, - { - "brief_title": "iStride(TM) Device Used for Stroke Rehabilitation", - "phase": "", - "drugs": "['wearing the iStride device']", - "drugs_list": [ - "wearing the iStride device" - ], - "diseases": "['Stroke']", - "diseases_list": [ - "Stroke" - ], - "enrollment": "6.0", - "inclusion_criteria": "inclusion criteria: \n\n age 21-80 \n\n one or more cerebral strokes, but all strokes on same side \n\n a stroke at least 6 months prior to enrollment \n\n Gait asymmetry, but able to walk independently with or without a cane \n\n Not currently receiving physical therapy \n\n no evidence of severe cognitive impairment that would interfere with understanding the instructions \n\n no evidence of one-sided neglect, affecting ambulation \n\n At least 25 feet of walking space in home (does not need to be a straight line) \n\n Weight does not exceed 250 lbs \n\n ", - "exclusion_criteria": ": \n\n uncontrolled seizures \n\n metal implants (stents, clips, pacemaker) \n\n pregnancy \n\n History of a neurological disorder other than stroke ( Parkinson's, MS) \n\n Chronic Obstructive Pulmonary Disease \n\n Uncontrolled blood pressure \n\n Head injury in the past 90 days \n\n A myocardial infarction within the last 180 days \n\n Cannot rely on a rolling walker for ambulation", - "brief_summary": "The objective of this research is to test a passive shoe to correct gait in individuals with asymmetric walking patterns. This will be done in a clinic. Individuals with central nervous system damage, such as stroke, often have irregular walking patterns and have difficulty walking correctly. Recent research has shown that using a split-belt treadmill can create after-effects that temporarily correct the inefficient walking patterns. However, the corrected walking pattern does not efficiently transfer from the treadmill to walking over ground. The iStride, formerly known as the Gait Enhancing Mobile Shoe (GEMS), may allow a patient to practice walking in many different locations, such as their own home, which we hypothesize will result in a more permanent transfer of learned gait patterns. To enable long-term use, our proposed shoe design is passive and uses the wearer's natural forces exerted while walking to generate the necessary motions.", - "NCTID": "NCT02185404" - } - ], - "1": [ - { - "brief_title": "Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients", - "phase": "", - "drugs": "['Seprafilm']", - "drugs_list": [ - "Seprafilm" - ], - "diseases": "['Open Abdomen', 'Abdominal Adhesions', 'Trauma', 'Wounds and Injury']", - "diseases_list": [ - "Open Abdomen", - "Abdominal Adhesions", - "Trauma", - "Wounds and Injury" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Trauma patients undergoing DC/OA management for traumatic injury \n\n Age 18+ \n\n Life expectancy longer than 48 hours \n\n ", - "exclusion_criteria": ": \n\n Prisoners \n\n Pregnant patients \n\n Younger than 18 years of age", - "brief_summary": "The goal of this study is to test the effects of Seprafilm adhesion barrier on patients who are undergoing open abdomen damage control management for traumatic injuries when compared to no adhesion barrier use. Specifically, the researchers wish to study the effects of Seprafilm adhesion barrier on:~the number and intensity of adhesions,~whether there is any difference between treatment groups (Seprafilm vs. no Seprafilm) who go on to successful definitive abdominal closure,~rate of occurrence of secondary complications (such as abscesses) associated with short- and long-term beneficial effects of reducing adhesion formation,and~whether there is any difference between treatment groups regarding patient functional recovery.", - "NCTID": "NCT01594385" - }, - { - "brief_title": "Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections", - "phase": "", - "drugs": "['IrriSept System', 'No Intervention - Standard of Care (SoC) only']", - "drugs_list": [ - "IrriSept System", - "No Intervention - Standard of Care (SoC) only" - ], - "diseases": "['Surgical Site Infection']", - "diseases_list": [ - "Surgical Site Infection" - ], - "enrollment": "627.0", - "inclusion_criteria": "inclusion criteria: \n\n Is male or female, 18 years of age or older \n\n Has provided written informed consent or has surrogate consent provided by a Legally Authorized Representative (LAR) \n\n Has experienced abdominal trauma, blunt or penetrating, requiring open abdominal laparotomy with primary closure or \n\n Has experienced acute surgical abdomen requiring open abdominal laparotomy with primary closure \n\n ", - "exclusion_criteria": ": \n\n Known allergy to Chlorhexidine Gluconate (CHG) \n\n Estimated Abbreviated Injury Scale (AIS) score of six (6) at the time of surgery, for all trauma patients \n\n American Society of Anesthesiologists Physical Status Classification (ASA) score of five (5) or greater (As ASA scoring is a subjective measure, if the PI finds the patient stable enough for study participation despite a score of 5, enrollment may continue.) \n\n Female volunteers who are pregnant and/or breast feeding \n\n Damage control laparotomy \n\n Abdominal incision created prior to operating room (i.e. incision made in trauma bay to cross clamp the aorta) \n\n Currently enrolled in an ongoing, interventional, randomized clinical trial", - "brief_summary": "The purpose of this study was to compare the rate of surgical site infections in patients randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen.", - "NCTID": "NCT02255487" - }, - { - "brief_title": "Enteral Feeding in the Post-Injury Open Abdomen", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Trauma to the Abdomen']", - "diseases_list": [ - "Trauma to the Abdomen" - ], - "enrollment": "515.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients with a post-injury open abdomen \n\n ", - "exclusion_criteria": ": \n\n Patients to be excluded from analysis include deaths within 24 hours, identification of injury > 24 hours, and those transferred from an outside hospital > 24 hours following initial injury.", - "brief_summary": "The purpose of this study is to determine if Enteral Feeding (EN) in patients with a traumatic bowel injury requiring an open abdomen impacts outcomes. Patients who receive EN will be compared to those who remain nil-per-os (NPO). Additionally, an internal study control will be performed by analyzing concurrent injured patients requiring an open abdomen who did not have a bowel injury.~Specific aims:~Hypothesis 1: EN in patients with a traumatic bowel injury requiring an open abdomen improves fascial closure rate compared to patients who remain NPO.~Hypothesis 2: EN in patients with a traumatic bowel injury requiring an open abdomen reduces infectious complications compared to patients who remain NPO.~Hypothesis 3: EN in patients with a traumatic bowel injury requiring an open abdomen have a lower mortality rate compared to patients who remain NPO.", - "NCTID": "NCT01853735" - }, - { - "brief_title": "Fibrinogen in the Initial Resuscitation of Severe Trauma (FiiRST)", - "phase": "Phase 1; Phase 2", - "drugs": "['Fibrinogen concentrate', 'Placebo Comparator']", - "drugs_list": [ - "Fibrinogen concentrate", - "Placebo Comparator" - ], - "diseases": "['Trauma', 'Injury', 'Bleeding', 'Haemorrhage', 'Coagulopathy']", - "diseases_list": [ - "Trauma", - "Injury", - "Bleeding", - "Haemorrhage", - "Coagulopathy" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n 1. Injured trauma (penetrating or blunt) patients who are at risk of significant bleeding, defined as: i. Systolic blood pressure (SBP) \u2264 100mmHg at any time from the injury scene until 30min after hospital admission AND ii. Red blood cell transfusion has been ordered by the trauma team leader (or delegate) \n\n ", - "exclusion_criteria": ": \n\n Patients in shock which the etiology is purely not related to bleeding: \n\n i. Cardiogenic (myocardial or valvular dysfunction); ii. Distributive (septic, anaphylactic, acute adrenal insufficiency and neurogenic) and iii. Obstructive (cardiac tamponade, tension pneumothorax and massive pulmonary emboli). \n\n Severe head injury, defined as any of the following: \n\n i. Glasgow coma scale (GCS) of 3 due to severe traumatic brain injury (TBI); ii. TBI with clear indication of immediate neurosurgical intervention based on clinical findings (mechanism of trauma associated with focal signs such as anisocoria with fixed pupil) or on CT results (bleeding causing mass effect); iii. Unsalvageable head injury such as through-through gunshot wound to the head, open skull fracture with exposure/loss of brain tissue; as per the trauma team or neurosurgery initial clinical assessment or as per initial CT of the head findings; \n\n Known complete or incomplete spinal cord injury; \n\n Known hereditary or acquired coagulopathies unrelated to the trauma resuscitation (e.g. known hepatic dysfunction); \n\n Use of anticoagulant medications such as warfarin, low-molecular weight heparin, and direct thrombin and factor Xa inhibitors; \n\n Moribund with evidence of unsalvageable injuries and withdrawal of care, as per the trauma team; \n\n Received blood products prior to admission; \n\n Patients with estimated body weight under 50Kg; \n\n Patients with known or suspected pregnancy; \n\n Patients arriving more than 6hr after injury.", - "brief_summary": "Trauma is the leading cause of death in people 44 years of age or younger. After major trauma, such as following high-speed motor vehicle collision, bleeding coupled with clotting defects is responsible for most of deaths in the first hours of hospital admission. Of note, these bleeding-related deaths are potentially preventable. Accordingly, the initial in-hospital management of severely injured patients focuses on stopping bleeding, replacing blood loss and correcting clotting defects.~Recently, animal and human research demonstrated that one of the major clotting defects following injury and bleeding is the drop in blood levels of fibrinogen (a clotting factor), which is detected on hospital admission in severely injured patients. These low fibrinogen levels are associated with increased blood transfusion and death. However, in North America, the standard of care for replacing low fibrinogen requires the use of cryoprecipitate, which is a frozen blood product with long preparation time, and similarly to other blood products, carries the risk of viral transmission and transfusion complications. Alternately, many Europeans countries where cryoprecipitate has been withdrawn from the market due to safety concerns, use fibrinogen concentrate. Fibrinogen concentrate undergoes pathogen inactivation, which is a process to eliminate the risk of transmitting viruses, bacteria and parasites, is likely a safer and faster alternative to cryoprecipitate. In Canada, fibrinogen concentrate is licensed for congenital low fibrinogen only.~Although preliminary data suggest that fibrinogen supplementation in trauma is associated with reduced bleeding, blood transfusion, and death, the feasibility, safety and efficacy of early fibrinogen replacement remains unknown. We proposed to conduct a feasibility randomized trial to evaluate the use of early fibrinogen concentrate against placebo in injured patients at our trauma centre.~A pilot trial is necessary to demonstrate the feasibility of rapidly preparing, delivering, and infusing fibrinogen concentrate as an early therapy to prevent excessive bleeding in trauma. This feasibility trial will provide preliminary safety and clinical outcome data to inform the design of larger trials; which ultimately aims to prevent bleeding-related deaths in the trauma population.", - "NCTID": "NCT02203968" - }, - { - "brief_title": "Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol", - "phase": "", - "drugs": "['Vacuum Pack', 'Double Sylo Bag - Mesh Protocol']", - "drugs_list": [ - "Vacuum Pack", - "Double Sylo Bag - Mesh Protocol" - ], - "diseases": "['Open Abdomen', 'Temporary Abdominal Closure Mechanisms']", - "diseases_list": [ - "Open Abdomen", - "Temporary Abdominal Closure Mechanisms" - ], - "enrollment": "52.0", - "inclusion_criteria": "inclusion criteria: \n\n Open Abdomen \n\n ", - "exclusion_criteria": ": \n\n Patients that die in the first 48 hours after the initial intervention", - "brief_summary": "The open abdomen is a valid and accepted surgical tactic for the trauma and acute care patient. There have been many mechanisms described for its management, but the most accepted strategy is the vacuum pack. At our hospital the investigators have used for many years a double sylo bag, one underneath the fascia and the other sutured to the skin, at the initial operation. At subsequent surgeries once the abdomen is clean the investigators leave the same subfascial sylo bag and use a prolene mesh attached to the fascia. Every day the investigators try to tighten the mesh with sutures until the abdomen can be closed. This study\u00b4s objective is to compare our double sylo bag- mesh protocol with the vacuum pack to determine which is related to a higher fascial closure rate.", - "NCTID": "NCT01864590" - }, - { - "brief_title": "Comparing Use of a Prehospital Ultrasound System and Standard Prehospital Care in Thoracoabdominal Trauma", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Thoracoabdominal Trauma', 'Focused Assessment With Sonography for Trauma (FAST)', 'NanoMaxx Ultrasound System (SonoSite)', 'RP-Xpress (InTouch Technologies)']", - "diseases_list": [ - "Thoracoabdominal Trauma", - "Focused Assessment With Sonography for Trauma (FAST)", - "NanoMaxx Ultrasound System (SonoSite)", - "RP-Xpress (InTouch Technologies)" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria for FAST cohort: \n\n Patient is 18 years of age or older \n\n Patient presenting with blunt or penetrating trauma to the thorax or abdomen \n\n Patient transported by MD Ambulance to Royal University Hospital \n\n Patient being transported by a paramedic who has received training in the above ultrasound system and who has with them a NanoMaxx Ultrasound System (SonoSite) to be used in connection with the RP-Xpress (InTouch Technologies) \n\n Patient will take longer than 10 minutes to transport to hospital \n\n Patient's care will not be compromised in completing a FAST exam - opinion of paramedic \n\n Patient's care will not be compromised in completing a FAST exam - opinion of ER physician \n\n inclusion criteria for Controls: \n\n Patient is 18 years of age or older \n\n Patient presenting with blunt or penetrating trauma to the thorax or abdomen \n\n Patient transported by MD Ambulance to Royal University Hospital \n\n Patient will take longer than 10 minutes to transport to hospital \n\n ", - "exclusion_criteria": ": \n\n Patients under the age of 18 \n\n Patients whose care would be compromised if other procedures of higher priority (as determined by paramedics and/or remotely-present physicians) were not be able to be executed due to time involved in completing a FAST exam \n\n Patients who are not being transported to Royal University Hospital \n\n Patients whose expected transport time from scene to hospital is less than 10 minutes", - "brief_summary": "The NanoMaxx Ultrasound System (SonoSite) in connection with the RP-Xpress (InTouch Technologies) provides a means of transmitting ultrasound images, video, and audio to a remote location in real-time. It has been envisioned that this system be used to diagnose trauma patients with suspected pleural effusion, hemothorax, pneumothorax, or abdominal blockage during prehospital care; under the guidance of in-hospital physicians, paramedics would perform an Focused Assessment with Sonography for Trauma (FAST) examination while trauma patients are transported to hospital via ambulance. The investigators hypothesize that in-hospital physicians interpreting ultrasound images obtained by paramedics during trauma patients' transportation to hospital will reduce time to diagnosis; thus, preparations by emergency physicians, surgeons, and operating room teams to receive critically injured patients may begin earlier, reducing time to intervention during a critical period in patient care. Data will also be collected regarding quality of images obtained in-ambulance and the interaction between paramedics and physicians using the remote-presence system.", - "NCTID": "NCT02198885" - }, - { - "brief_title": "An Adhesion Reduction Plan in the Management of the Surgical Open Abdomen", - "phase": "", - "drugs": "['Adhesion Reduction Plan']", - "drugs_list": [ - "Adhesion Reduction Plan" - ], - "diseases": "['Open Abdomen']", - "diseases_list": [ - "Open Abdomen" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Trauma patients with open abdomen after initial laparotomy \n\n Emergency surgery patients with open abdomen after initial laparotomy \n\n Able to obtain consent from patient or LAR before any research initiated \n\n ", - "exclusion_criteria": ": \n\n Seprafilm application at initial laparotomy \n\n Patient is a prisoner \n\n Inability to obtain informed consent \n\n Consentable person does not speak English", - "brief_summary": "The purpose of this study is to determine whether an adhesion reduction plan, consisting of early adhesion prevention and application of a bioresorbable membrane is effective in reducing the severity of adhesions and the incidence of complications in managing the open abdomen in trauma and emergency general surgery.", - "NCTID": "NCT01010464" - }, - { - "brief_title": "Peritoneal/ Serum Lactate Ratio in Relaparotomy", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Surgical Complications', 'Relaparotomy']", - "diseases_list": [ - "Surgical Complications", - "Relaparotomy" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Post operative period of abdominal surgery (elective surgery of:colon-rectum, ileum, stomach and, pancreas) \n\n Post operative period after Urgent laparotomy for both traumatic and/or non traumatic acute abdomen \n\n Patients with signs of sepsis in the post operative period \n\n Patients with signs of systemic hypoperfusion in the post operative \n\n ", - "exclusion_criteria": ": \n\n Liver surgery \n\n Drainage of bile, blood and dejection from abdominal drainage \n\n Sepsis/ systemic hypoperfusion due to extraabdominal infection site", - "brief_summary": "Laparotomy performed for both emergency of elective surgery may by complicated by intrabdominal collection, anastomotic leakage, infarction and others. This conditions are able to induce peritoneal inflammation. Inflamed peritoneum are able to produce excess of lactate that the investigators can measure by collecting fluid from peritoneal drainage.~Drainage were left in abdomen for monitoring intrabdominal condition until the passage of stool or flatus. Minimum drainage of serum is present daily also in uncomplicated post operative period.~Serum lactate relates with increased systemic anaerobic metabolism such as SIRS, sepsis and systemic hypoperfusion and it is easy to measure with a blood gas analysis.~The investigators hypothesized that the increases of peritoneal/ serum lactate ratio could be an earlier, sensible, non-invasive, and economical marker of post surgical complications. The decision whether and when to perform a relaparotomy in secondary peritonitis is largely subjective and based on professional experience. Actually no existing scoring system aids in this decision.~The aim of this study is to demonstrate that this ratio could be and useful tool for the surgeon in this decisional process.", - "NCTID": "NCT01161849" - } - ], - "2": [ - { - "brief_title": "Utility of Abdominal Ultrasound in the Evaluation of Children With Blunt Trauma", - "phase": "", - "drugs": "['Abdominal Ultrasound (FAST examination)']", - "drugs_list": [ - "Abdominal Ultrasound (FAST examination)" - ], - "diseases": "['Abdominal Injuries']", - "diseases_list": [ - "Abdominal Injuries" - ], - "enrollment": "925.0", - "inclusion_criteria": "inclusion criteria: \n\n Blunt torso trauma resulting from a significant mechanism of injury \n\n Motor vehicle collision: greater than 60 mph, ejection, or rollover \n\n Automobile versus pedestrian/bicycle: automobile speed > 25 mph \n\n Falls greater than 20 feet in height \n\n Crush injury to the torso \n\n Physical assault involving the abdomen \n\n Decreased level of consciousness (Glasgow Coma Scale score < 15 or below age-appropriate behavior) in association with blunt torso trauma \n\n Blunt traumatic event with any of the following (regardless of the mechanism): \n\n Extremity paralysis \n\n Multiple long bone fractures (e.g., tibia and humerus fracture) \n\n History and physical examination suggestive of intra-abdominal injury following blunt torso trauma of any mechanism (including mechanisms of injury of less severity than mentioned above) \n\n ", - "exclusion_criteria": ": \n\n No concern for inter-abdominal injury or no planned evaluation for possible IAI \n\n Prehospital or ED age adjusted Hypotension \n\n Prehospital or initial ED GCS score \u2264 8 \n\n Presence of an abdominal seat belt sign - continuous area of erythema/contusion completely across the lower abdomen secondary to a lap belt \n\n Penetrating trauma: stab or gunshot wounds \n\n Traumatic injury occurring > 24 hours prior to the time of presentation to the ED \n\n Transfer of the patient to the UCDMC ED from an outside facility with abdominal CT scan, diagnostic peritoneal lavage, or laparotomy previously performed \n\n Patients with known disease processes resulting in intraperitoneal fluid including liver failure and the presence of ventriculoperitoneal shunts", - "brief_summary": "The major goal of this project is to conduct a randomized controlled trial studying an initial evaluation strategy with abdominal ultrasound versus a strategy without abdominal ultrasound for the evaluation of children with blunt abdominal trauma. The proposal's objectives are to compare the following variables in those that randomize to abdominal ultrasound versus those that do not:~rate of abdominal CT scanning~time to emergency department disposition~the rate of missed/delayed diagnosis of intra-abdominal injury~the costs.", - "NCTID": "NCT01540318" - }, - { - "brief_title": "Pelvic CT Imaging in Blunt Abdominal Trauma", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Blunt Abdominal Trauma']", - "diseases_list": [ - "Blunt Abdominal Trauma" - ], - "enrollment": "230.0", - "inclusion_criteria": "inclusion criteria: \n\n 3-60 years of age evaluated for blunt trauma with a GCS of >14 \n\n Order of CT abdomen and pelvis imaging \n\n ", - "exclusion_criteria": ": \n\n Patients requiring intubation or suspected neurological injury (defined above) \n\n Pregnant patients \n\n Intoxicated patients \n\n Patients with age defined hypotension \n\n Exploratory laparotomy or transfusion during the ED evaluation \n\n Non-verbal patients \n\n Positive FAST exam \n\n Patients with abdominal trauma or surgery in the last month \n\n Victims of sexual assault or non-accidental trauma (NAT) \n\n Patients with known or suspected fractures of the femur or pelvis prior to CT imaging \n\n Patients with hip dislocations", - "brief_summary": "Abdominopelvic CT (CTap) utilization rose significantly in blunt trauma patients over the last decade. However, the observed increases failed to reduce mortality or missed injury rates. Several investigators have derived (citation) and validated (citation) clinical decision rules that attempt to identify a subset of low risk pediatric and adult patients in whom abdominopelvic CT imaging can be safely eliminated. Thus far these efforts failed to significantly reduce utilization. The investigators propose an alternative and complimentary strategy to decrease radiation by selectively eliminating the pelvic imaging portion of the abdominopelvic CT in low risk patients. In stable, alert patients without clinically evidence of pelvis or hip fractures, abdominal CT imaging alone (diaphragm to iliac crest) identifies clinically significant intra-abdominal injury (cs-IAI) as accurately as routine abdominopelvic imaging (diaphragm to greater trochanter) and results in a clinically important decrease in radiation exposure. The study will investigate this by comparing the accuracy of an imaging protocol using CT abdomen alone versus CT abdomen and pelvis to detect cs-IAI among stable, blunt trauma patients without suspected pelvis or hip fractures in two age groups: ages 3-17 years and 18-60. Patients will undergo CT imaging as deemed clinically indicated by the treating clinician. Among those who have abdominopelvic CT scans, the study will determine the test characteristics of CT abdomen alone versus CT abdomen plus CT pelvis imaging for the identification of cs-IAI. The reference standard will include initial radiology reports, with structured follow up of indeterminate scans, operative reports, and 7-day medical record review.", - "NCTID": "NCT01828749" - }, - { - "brief_title": "DEPITAC : Short Screening Scale for Psychotraumatic Disorders After Motor Vehicle Accident", - "phase": "", - "drugs": "['DEPITAC']", - "drugs_list": [ - "DEPITAC" - ], - "diseases": "['Stress Disorders, Post-Traumatic', 'Stress Disorders, Traumatic, Acute']", - "diseases_list": [ - "Stress Disorders", - "Post-Traumatic", - "Stress Disorders", - "Traumatic", - "Acute" - ], - "enrollment": "274.0", - "inclusion_criteria": "inclusion criteria: \n\n Road traffic accident victims hospitalized in surgical department less than 2 weeks \n\n Can be called by phone \n\n ", - "exclusion_criteria": ": \n\n Patient with a coma for more than 15 minutes \n\n Patient with a crania traumatism and with loss of consciousness over 15 minutes \n\n Homeless", - "brief_summary": "Posttraumatic stress disorder (PTSD) is a serious and often chronic response to overwhelmingly stressful events as Road Traffic Accident. Moreover PTSD is associated with increased rates of medical morbidity, poor health-related quality of life, and functional impairment. PTSD is prevalent in primary care settings after road traffic accident, where approximately 25% of patients meet diagnostic criteria for the disorder. Despite the development of a number of efficacious behavioral and pharmacological treatments, only a minority of patients with PTSD receive mental health services. PTSD is frequently underrecognized and untreated in Emergency Department and Surgical Unit.~Then, early diagnosis and prevention of PTSD might help to identify patients with PTSD high risk and lead them to benefit of personalized cares. Nevertheless it is not possible (neither useful) to provide psychological cares for each road traffic accident victim.~This is the reason why we think that nurses can help to screen patients who need treatment for PTSD Hypothesis : Recognition of specific clinical or biological signs occurring during road traffic accident victim hospitalization in surgical unit could allow beginning specific treatment using consultation liaison psychiatry.~Early treatment could allow decreasing incidence of psychotraumatic disorders, increasing surgical functional efficacy and improve convalescence programs. The use of a specific questionnaire could help to screen this disorder.~We have created the DEPITAC scale : a short screening questionnaire with 10 items.~This study will be evaluated DEPITAC's 10-item screen for posttraumatic stress disorder (PTSD) for use in surgical or emergency department.", - "NCTID": "NCT01200628" - }, - { - "brief_title": "The Impact of Sleep Disorders on Motor Vehicle Accidents", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Sleep Disorders']", - "diseases_list": [ - "Sleep Disorders" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria:Drivers admitted as result of motor vehicle accidents - \n\n ", - "exclusion_criteria": ":Drivers aged < 18 years \n\n -", - "brief_summary": "Patients who have sleep disorders may be involved in accidents more frequently than those without. In addition patients who have sleep disorders may have more serious accidents and have increased length of stay.We aim to recruit drivers admitted as a result of a motor vehicle accidents and to ascertain the prevalence of sleep disorders in this group.", - "NCTID": "NCT00163670" - }, - { - "brief_title": "Energy Drinks & Driving Ability", - "phase": "", - "drugs": "['Red Bull Energy drink']", - "drugs_list": [ - "Red Bull Energy drink" - ], - "diseases": "['Driver Sleepiness']", - "diseases_list": [ - "Driver Sleepiness" - ], - "enrollment": "24.0", - "inclusion_criteria": "inclusion criteria: \n\n He/she is aged between 21 and 35 years old \n\n BMI between 21 and 30, \n\n 55-85 kg body weight \n\n Non smoker \n\n Written informed consent \n\n Normal static binocular acuity, corrected or uncorrected \n\n Normal hearing \n\n Possession of a valid driver's license for at least 3 years \n\n Regular driver (> 5000 km / year) \n\n Be considered as reliable and mentally capable of adhering to the protocol. \n\n ", - "exclusion_criteria": ": \n\n Current drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates) as will be assessed by a urine drug test \n\n Use of psychoactive medication \n\n Pregnancy \n\n Positive alcohol breath test \n\n Prior enrolment in the same study \n\n Physical or mental illness \n\n Excessive alcohol use (>21 alcoholic drinks per week) \n\n Intake of caffeine-containing beverages under 2 or over 4 glasses per day \n\n Regular consumption of Energy Drinks (>1 per month) \n\n Shift worker (or no regular sleep pattern) \n\n Epworth Sleepiness Score (ESS) > 10", - "brief_summary": "Rationale: Sleepiness behind the wheel is the cause of many traffic accidents. It is claimed that a 15-minute break and consuming an energy drink such as Red Bull\u00ae Energy Drink counteracts driver sleepiness.~Objective: The objective of this study is to compare driving simulator performance after (1) a 15-minute break with placebo, (2) a 15-minute break with Red Bull\u00ae Energy Drink, and (3) continued driving.~Study design: A double-blind, placebo-controlled crossover study. Study population: Healthy human volunteers, 21-35 years old.~Intervention: Each subject performs 3 test days:~4 hours continued driving~2 hours driving, a 15-minute break + Red Bull\u00ae Energy Drink, followed by 2 hours driving~2 hours driving, a 15-minute break + placebo, followed by 2 hours driving Main study parameters/endpoints: Standard Deviation of Lateral Position (SDLP), i.e. the weaving of the car.", - "NCTID": "NCT01007877" - }, - { - "brief_title": "Low-dose CT Using Iterative Reconstruction in Patients With Inflammatory Bowel Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Inflammatory Bowel Disease', \"Crohn's Disease\", 'Ulcerative Colitis']", - "diseases_list": [ - "Inflammatory Bowel Disease", - "Crohn's Disease", - "Ulcerative Colitis" - ], - "enrollment": "250.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult patients requiring a CT abdomen for clinical purposes will be included \n\n ", - "exclusion_criteria": ": \n\n Pediatric patients", - "brief_summary": "The purpose of this study is to validate the use of a low-dose computed tomography (CT) protocol and facilitate reduced radiation doses in patients with inflammatory bowel disease (IBD). This is to be achieved using new computer software (Iterative Reconstruction and Automatic Tube Modulation) which will enable low-dose CT imaging at doses equivalent to that of an abdominal radiograph.", - "NCTID": "NCT01244386" - } - ] - }, - { - "patient_id": "sigir-201421", - "patient": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", - "0": [ - { - "brief_title": "Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion", - "phase": "Phase 3", - "drugs": "['hydroxychloroquine (Z0188)', 'Placebo']", - "drugs_list": [ - "hydroxychloroquine (Z0188)", - "Placebo" - ], - "diseases": "['Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus']", - "diseases_list": [ - "Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus" - ], - "enrollment": "103.0", - "inclusion_criteria": "inclusion criteria : \n\n Patients diagnosed as cutaneous lupus erythematosus (CLE) \n\n ", - "exclusion_criteria": ": \n\n Patients receiving corticosteroid more than 15mg/day of the equivalent dose of prednisolone. \n\n Patients whose CLASI activity scores were less than 4 point at the initiation of Screening (Visit 1) and Day1 (Visit 2) (evaluated by a dermatology specialist). \n\n Patients whose fluctuations of CLASI activity scores were \u226520% between Visit 1 and Visit 2 (evaluated by a dermatology specialist). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.", - "brief_summary": "Primary Objective:~- To investigate the efficacy on skin manifestation of 16 weeks treatment of once daily regimen of hydroxychloroquine sulphate (HCQ) in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) with active skin manifestation (CLASI [Cutaneous Lupus Erythematosus Disease Area and Severity Index] activity score is \u22654) concomitant treatment with or without corticosteroid.~Secondary Objectives:~To evaluate the efficacy on skin manifestation and the safety of 16 weeks treatment of once daily regiment of HCQ versus placebo as the reference group in patients with CLE and SLE with active skin manifestation (CLASI activity score is \u22654) concomitant treatment with or without corticosteroid.~To investigate the safety of 16 weeks treatment of once daily regiment of HCQ in patients with CLE and SLE with active skin manifestation concomitant treatment with or without corticosteroid.~To investigate the safety and efficacy of 52 weeks long-term treatment of once daily regimen of HCQ in patients with CLE and SLE - To investigate the influence of the dose reduction of corticosteroid on CLE and SLE patients treated with HCQ concomitant with corticosteroid~To investigate efficacy of once daily regimen of HCQ on systemic symptoms, musculoskeletal symptoms and immunological parameters in SLE patients.", - "NCTID": "NCT01551069" - }, - { - "brief_title": "The Research Registry for Neonatal Lupus", - "phase": "", - "drugs": "['No intervention; observational']", - "drugs_list": [ - "No intervention; observational" - ], - "diseases": "['Neonatal Lupus', 'Systemic Lupus Erythematosus', \"Sjogren's Syndrome\", 'Congenital Heart Block']", - "diseases_list": [ - "Neonatal Lupus", - "Systemic Lupus Erythematosus", - "Sjogren's Syndrome", - "Congenital Heart Block" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Mother with antibodies to SSA/Ro, SSB/La, or ribonucleoproteins (RNP) OR Child of mother with such antibodies who has neonatal lupus (congenital heart block, transient skin rash, and/or hepatic or hematologic manifestations) OR Father of neonatal lupus-affected child OR Maternal grandparents of neonatal lupus-affected child OR Maternal aunts and uncles of neonatal lupus-affected OR Unaffected siblings of neonatal lupus-affected child", - "exclusion_criteria": "", - "brief_summary": "Women with lupus and other related disorders produce certain antibodies in the blood. Some women have these antibodies even if they have not yet developed symptoms of lupus or Sjogren's syndrome. When these women become pregnant, they may pass the antibodies to their infants. The infants may then develop a disease called neonatal lupus. The symptoms of neonatal lupus include an abnormally slow heart beat (heart block) and a skin rash. This registry collects information on women and infants affected by neonatal lupus as well as other family members who may be healthy.", - "NCTID": "NCT00074373" - }, - { - "brief_title": "CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis", - "phase": "Phase 3", - "drugs": "['Blisibimod', 'Placebo']", - "drugs_list": [ - "Blisibimod", - "Placebo" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology \n\n Positive antinuclear antibodies (ANA) and/or anti-double stranded DNA (anti-dsDNA) \n\n Active SLE disease as defined by SELENA-SLEDAI score \u226510 despite on-going stable corticosteroid therapy \n\n Subjects with stable nephritis may be enrolled \n\n 18 years of age or older \n\n ", - "exclusion_criteria": ": \n\n Severe active vasculitis, active central nervous system lupus, uncontrolled hypertension or poorly controlled diabetes \n\n Malignancy within past 5 years \n\n Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C \n\n Liver disease \n\n Anemia, neutropenia, or thrombocytopenia \n\n Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections \n\n History of active tuberculosis or a history of tuberculosis infection \n\n Pregnant or nursing", - "brief_summary": "The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in subjects who, despite corticosteroid use, continue to have autoantibody positive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by SELENA SLEDAI score \u226510.", - "NCTID": "NCT02074020" - }, - { - "brief_title": "Rituximab and Belimumab for Lupus Nephritis", - "phase": "Phase 2", - "drugs": "['Rituximab', 'Cyclophosphamide', 'Prednisone', 'Methylprednisolone', 'Diphenhydramine', 'Acetaminophen', 'Rituximab', 'Cyclophosphamide', 'Prednisone', 'Methylprednisolone', 'Diphenhydramine', 'Acetaminophen', 'Belimumab']", - "drugs_list": [ - "Rituximab", - "Cyclophosphamide", - "Prednisone", - "Methylprednisolone", - "Diphenhydramine", - "Acetaminophen", - "Rituximab", - "Cyclophosphamide", - "Prednisone", - "Methylprednisolone", - "Diphenhydramine", - "Acetaminophen", - "Belimumab" - ], - "diseases": "['Lupus Nephritis']", - "diseases_list": [ - "Lupus Nephritis" - ], - "enrollment": "43.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria. \n\n Positive antinuclear antibody (ANA) or positive anti-ds DNA test results at visit -1 or any time within 14 days before visit -1. \n\n Active proliferative lupus nephritis, as defined by either of the following: \n\n Kidney biopsy documentation within the last 3 months of International Society of Nephrology/Renal Pathology Society (ISN/RPS) proliferative nephritis: Class III, Class IV, or Class V in combination with Class III or IV. \n\n Active urinary sediment and kidney biopsy documentation within the last 12 months of ISN/RPS proliferative nephritis: Class III, Class IV, or Class V in combination with Class III or IV. Active urinary sediment is defined as any one of the following: \n\n >5 RBC/hpf in the absence of menses and infection; \n\n >5 White blood cell per high powered field (WBC/hpf) in the absence of infection; or \n\n Cellular casts limited to RBC or WBC casts. \n\n Urine protein-to-creatinine ratio (UPCR) >1 at study entry based on a 24-hour collection. \n\n Ability to provide informed consent. \n\n ", - "exclusion_criteria": ": \n\n New onset lupus nephritis, defined as lupus nephritis for which the participant has not yet been treated with either mycophenolate mofetil or cyclophosphamide. \n\n Neutropenia (absolute neutrophil count <1500/mm^3). \n\n Thrombocytopenia (platelets <50,000/mm^3). \n\n Moderately severe anemia (Hgb < mg/dL). \n\n Moderately severe hypogammaglobulinemia (IgG <450 mg/dL) or Immunoglobulin A (IgA) <10mg/dL. \n\n Positive QuantiFERON -Tuberculosis (TB) Gold test results. \n\n Pulmonary fibrotic changes on chest radiograph consistent with prior healed tuberculosis. \n\n Active bacterial, viral, fungal, or opportunistic infections. \n\n Evidence of infection with human immunodeficiency virus (HIV), hepatitis B (as assessed by HBsAg and anti-HBc) or hepatitis C. \n\n Hospitalization for treatment of infections, or parenteral (IV or IM) antibacterials, antivirals, anti-fungals, or anti-parasitic agents within the past 60 days. \n\n Chronic infection that is currently being treated with suppressive antibiotic therapy, including but not limited to tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, and atypical mycobacteria. \n\n History of significant infection or recurrent infection that, in the investigator's opinion, places the participant at risk by participating in this study. \n\n Receipt of a live-attenuated vaccine within 3 months of study enrollment. \n\n End-stage renal disease (eGFR <20 mL/min/1.73m^2). \n\n Concomitant malignancies or a history of malignancy, with the exception of adequately treated basal and squamous cell carcinoma of the skin, or carcinoma in situ of the cervix. \n\n History of transplantation. \n\n History of primary immunodeficiency. \n\n Pregnancy. \n\n Breastfeeding. \n\n Unwillingness to use an FDA-approved form of birth control (including but not limited to a diaphragm, an intrauterine device, progesterone implants or injections, oral contraceptives, the double-barrier method, or a condom). \n\n Use of cyclophosphamide within the past 6 months. \n\n Use of anti-Tumor Necrosis Factor (TNF) medication, other biologic medications, or experimental non- biologic therapeutic agents within the past 90 days, or 5 half-lives prior to screening, whichever is greater. \n\n Intravenous immunoglobulin (IVIG), plasmapheresis, or leukopheresis within the past 90 days. \n\n Use of investigational biologic agent within the past 12 months. \n\n Prior treatment with rituximab, belimumab, atacicept, or other biologic B cell therapy. \n\n Liver function test [aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase] results that are >=2 times the upper limit of normal. \n\n Severe, progressive, or uncontrolled renal, hepatic, hematological,gastrointestinal, pulmonary, cardiac, or neurological disease, either related or unrelated to SLE, with the exception of active lupus nephritis (or, in the investigator's opinion, any other concomitant medical condition that places the participant at risk by participating in this study). \n\n Comorbidities requiring corticosteroid therapy, including those which have required three or more courses of systemic corticosteroids within the previous 12 months. \n\n Current substance abuse or history of substance abuse within the past year. \n\n History of severe allergic or anaphylactic reactions to chimeric or fully human monoclonal antibodies. \n\n History of anaphylactic reaction to parenteral administration of contrast agents. \n\n Lack of peripheral venous access. \n\n History of severe depression or severe psychiatric condition. \n\n History of suicidal thoughts within the past 2 months or suicidal behavior within the past 6 months, or a significant suicide risk in the investigator's opinion. \n\n Inability to comply with study and follow-up procedures.", - "brief_summary": "In this experimental study, researchers will try to find out if treatment of lupus nephritis with a combination of rituximab and cyclophosphamide (CTX), or a combination of rituximab and CTX followed by treatment with belimumab is safe and if this drug combination can block the immune system attacks.", - "NCTID": "NCT02260934" - }, - { - "brief_title": "BEL114333, a Continuation Study of BEL113750 in Subjects With Systemic Lupus Erythematosus (SLE) in Northeast Asia, and in Japan Subjects Completing the Open-label Extension of HGS1006-C1115", - "phase": "Phase 3", - "drugs": "['Belimumab']", - "drugs_list": [ - "Belimumab" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "142.0", - "inclusion_criteria": "inclusion criteria: \n\n Have completed the BEL113750 Protocol in Northeast Asia through Week 48 OR have completed the open-label extension of C1115 in Japan. \n\n Be able to receive the first dose of belimumab for BEL114333 four weeks (minimum of 2 weeks, maximum of 8 weeks) after the last dose in BEL113750 OR be able to receive the first dose of IV belimumab 1 week (plus a 1 week visit window) after the last dose of open-label SC belimumab in C1115.. \n\n ", - "exclusion_criteria": ": \n\n Have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an adverse event (AE) in the Phase 3 study that could, in the opinion of the principal investigator, put the subject at undue risk. \n\n Have developed any other medical diseases (e.g., cardiopulmonary), laboratory abnormalities, or conditions (e.g., poor venous access) that in the opinion of the principal investigator, makes the subject unstable for the study.", - "brief_summary": "This study provides subjects who complete the BEL113750 study and subjects who complete the open-label extension of HGS1006-C1115 (referred to as C1115) Study in Japan the option of continuing treatment with belimumab (10 mg/kg intravenously every 4 weeks) for those randomized to belimumab, or the option to begin treatment with belimumab for those randomized to placebo, as an add-on to their standard of care SLE therapy.", - "NCTID": "NCT01597622" - }, - { - "brief_title": "Levothyroxine in Pregnant SLE Patients", - "phase": "Phase 4", - "drugs": "['Levothyroxine']", - "drugs_list": [ - "Levothyroxine" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n All SLE (Systemic Lupus Erythematosus) pregnant women (aged 18 - 45 years) before 14 weeks of gestation, with autoimmune thyroid antibodies \n\n ", - "exclusion_criteria": ": \n\n SLE (Systemic Lupus Erythematosus) patients already on levothyroxine. Those patients discovered to be hypothyroid who need levothyroxine as part of standard of care", - "brief_summary": "The last two decades have witnessed an explosion of new research documenting the deleterious impact that thyroid disease has on pregnancy and the postpartum period, in relation to miscarriage preterm delivery intelligence quotient of the unborn child and health of the mother postpartum. Both subclinical hypothyroidism and thyroid antibody positivity in euthyroid women have been associated with miscarriage and preterm delivery. Approximately 5% of all pregnant women have a thyroid disorder. both spontaneous miscarriage and preterm delivery.~Systemic lupus erythematosus (SLE), an autoimmune disorder of unknown etiology, has also been documented to negatively impact pregnancy. Women with Systemic lupus erythematosus (SLE)have increased rates of miscarriage and preterm delivery. Women with Systemic lupus erythematosus (SLE) also have increased rates of hypothyroidism and autoimmune thyroid disease (AITD, defined as the presence of thyroid antibodies with or without thyroid dysfunction). Preterm delivery (PTD), defined as birth prior to 37 weeks gestation, is the leading cause of neonatal mortality and morbidity in the United States. Although risk factors for preterm delivery exist, the majority of women have no known risk factors. Recently, both hypothyroidism and autoimmune thyroid disease have also been linked to preterm delivery. Given the increased prevalence of negative outcomes documented in pregnant women with thyroid disease, and the increased rates of hypothyroidism and Autoimmune thyroid disease in women with Systemic lupus erythematosus (SLE), the investigators determined that Autoimmune thyroid disease was associated with both preterm delivery and miscarriage. This has led to this application to begin a pilot randomized clinical trial of thyroxine in autoimmune thyroid disease in systemic lupus erythematosus pregnancy.", - "NCTID": "NCT01276782" - }, - { - "brief_title": "Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE", - "phase": "Phase 3", - "drugs": "['Hydroxychloroquine', 'Cyclophosphamide', 'Azathioprine', 'Methylprednisolone']", - "drugs_list": [ - "Hydroxychloroquine", - "Cyclophosphamide", - "Azathioprine", - "Methylprednisolone" - ], - "diseases": "['Thrombocytopenia']", - "diseases_list": [ - "Thrombocytopenia" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients fulfilled the 1997 ACR modified or SLICC classification criteria of SLE\uff1b \n\n New onset thrombocytopenia: platelet count <30X109/L(by both routine test and citric acid anti-coagulated blood count test) within 3 months \n\n ", - "exclusion_criteria": ": \n\n Thrombocytopenia caused by other reasons, including drugs\uff1b \n\n Positive for active HAV(hepatitis A virus)/HBV(hepatitis B virus) infection \n\n Active HIV(human immunodeficiency virus) or HCV(hepatitis C virus) infection; \n\n Active HP(Helicopter pylori) infection; \n\n Severe liver and kidney dysfunction\uff1b \n\n Severe neuropsychiatric lupus\uff1b \n\n No response to high dose steroid and/or cyclophosphamide 1 month prior to study enrollment\uff1b \n\n Uncontrolled diabetes or hypertension before entry \n\n Active GI bleeding 3 months before entry \n\n Intolerant to HCQ in the past treatment history\uff1b \n\n Severe bone marrow suppression or liver damage caused by cyclophosphamide in the past history\uff1b \n\n Active infection , including bacteria, virus, fungi, mycobacteria \n\n Allergy to any of the study medications \n\n Confirmed TTP(thrombolic thrombocytopenic purpura)or CAPS(catastrophic anti-phosphilipid syndrome) \n\n Platelet count less than 20X109/L with active bleeding \n\n Myelodysplastic diseases \n\n Patients with heart and lung function impairment \n\n thiopurine S-methyltransferase (TPMT) gene positive -", - "brief_summary": "Treating severe thrombocytopenia is a challenge in the management of systemic lupus erythematosus. Although rheumatologists have followed some rules in real practice,there is very few evidence to support the current treatment algorithm. The purpose of this study is to compare the complete remission rate and partial remission rate of cyclophosphamide and hydroxychloroquine for treating severe thrombocytopenia in Chinese SLE patients.", - "NCTID": "NCT02444728" - }, - { - "brief_title": "Prognosis Assessment of the Increase of GADD34 Gene Expression for Patient Suffering From Systemic Lupus Erythematosus", - "phase": "", - "drugs": "['GADD34 RNA level measurement.']", - "drugs_list": [ - "GADD34 RNA level measurement." - ], - "diseases": "['Lupus Erythematosus']", - "diseases_list": [ - "Lupus Erythematosus" - ], - "enrollment": "143.0", - "inclusion_criteria": "inclusion criteria: \n\n man and women over 18 Years old. \n\n suffering from SLE (American College of Rheumatology criteria). \n\n without SLE flare for 3 months. \n\n with a signed consent and social security affiliation (required in France). \n\n ", - "exclusion_criteria": ": \n\n Viral infection within 15 days. \n\n Other chronic inflammatory disease. \n\n People with special protection (defined in articles : L1121- \u00a75-8 et articles L3212-\u00a71-3 of French health care law).", - "brief_summary": "Given that GADD34 has been described as a potential key regulator of pro-inflammatory cytokine production in human and elevated blood marker in SLE patients, this study aim to prove that the GADD34 RNA level in mononuclear blood cells can be used as a prognostic marker to assess the risk of SLE flare.", - "NCTID": "NCT02455089" - }, - { - "brief_title": "Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment in Quiescent Systemic Lupus", - "phase": "Phase 3", - "drugs": "['prednisone discontinuation']", - "drugs_list": [ - "prednisone discontinuation" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "136.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with SLE according to the ACR revised criteria. \n\n Quiescent disease without flare since at least one year (SELENA SLEDAI < or equal to 4, BILAG C, D or E, PGA 0) _ Treatment with 5 milligrams/day of prednisone since at least 1 year \n\n ", - "exclusion_criteria": ": \n\n failure to sign the informed consent or unable to consent \n\n Patient participating to another clinical trial \n\n Pregnancy or plan to become pregnant", - "brief_summary": "Systemic Lupus (SLE) is a chronic disease for which long term treatments are warranted. The aim of this study was to study the possibility of corticosteroids interruption in patients with quiescent SLE treated since at least one year with 5 milligrams of predonisone per day.", - "NCTID": "NCT02558517" - }, - { - "brief_title": "Cutaneous Lupus Medication Experience Study", - "phase": "", - "drugs": "['fluocinonide 0.05% cream']", - "drugs_list": [ - "fluocinonide 0.05% cream" - ], - "diseases": "['Cutaneous Lupus']", - "diseases_list": [ - "Cutaneous Lupus" - ], - "enrollment": "11.0", - "inclusion_criteria": "inclusion criteria: \n\n Any male or female 12 years or older of age with a diagnosis of cutaneous lupus by a dermatologist \n\n Capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed \n\n Able to complete the study and comply with study instructions, including attending all study visits \n\n ", - "exclusion_criteria": ": \n\n Individuals younger than 12 years of age \n\n Known allergy or sensitivity to study medication \n\n Inability to complete all study-related visits \n\n Introduction of any other prescription medication, topical or systemic, for cutaneous lupus while participating in the study", - "brief_summary": "Cutaneous lupus is a chronic, relapsing, auto-immune skin disease that can have many presentations. Its effect on physical appearance greatly affects patients' quality of life. In addition, 10% of patients with cutaneous lupus will develop systemic lupus. Topical therapies are the mainstay of cutaneous lupus treatment; however patients often find these treatments to be messy, inconvenient, or ineffective. In addition, for more severe disease patients are often placed on concurrent systemic therapies. The primary hypothesis of our study is that poor adherence contributes to poor treatment outcomes in patients with cutaneous lupus.", - "NCTID": "NCT02176148" - }, - { - "brief_title": "Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment", - "phase": "", - "drugs": "['Autologous Platelet Rich Plasma', 'Saline solution injection']", - "drugs_list": [ - "Autologous Platelet Rich Plasma", - "Saline solution injection" - ], - "diseases": "['Androgenetic Alopecia']", - "diseases_list": [ - "Androgenetic Alopecia" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n Men and women, age 18-60 with AGA \n\n Completed informed consent form \n\n Ludwig stage 1-2 for women \n\n Norwood Hamilton Stage 3 to 5 for men \n\n ", - "exclusion_criteria": ": \n\n Pregnancy or breastfeeding \n\n Younger than 18 years \n\n Uses of minoxidil and/or 5-alpha reductase inhibitors (such as finasteride or dutasteride) within 3 months of enrolling in the study \n\n History of hair transplantation \n\n Use of any cosmetic product aimed at improving or correcting the signs of hair loss within 2 weeks prior to screening \n\n Facial cancer (squamous and basal cell carcinoma, melanoma) \n\n Hereditary or acquired hematologic/coagulation disorders such as: platelet dysfunction syndrome, critical thrombocytopenia, hypofibrinogenemia, impaired coagulation, drepanocytosis (sickle cell anemia). \n\n Hemodynamic instability \n\n Acute infection \n\n Auto-immune disease such as Hashimoto, rheumatoid arthritis, or lupus (exception: vitiligo and alopecia areata) \n\n Malignancy with or without metastatic disease \n\n Chemotherapy \n\n Dermatological diseases affecting the face (e.g. porphyria) \n\n Anticoagulant therapy \n\n Patients taking Aspirin or other NSAIDs (Nonsteroidal anti-inflammatory drugs) such as Nurofen, Voltaren, Diclofenac or Naproxen can participate, provided medication is interrupted 7 days before beginning of the treatment \n\n Patients taking vitamin E supplements can participate, provided medication is interrupted 14 days before beginning of the treatment", - "brief_summary": "Platelet rich plasma (PRP) therapy is a novel therapeutic modality that has seen broad applications for a number of medical indications including those in orthopedics, dentistry, and dermatology. In dermatology, its uses have included treatment of chronic wounds and facial rejuvenation. More recently, anecdotal reports have suggested some efficacy in the treatment of hair loss, but to the best of our knowledge, there has been only one published case series documenting its use for this indication.", - "NCTID": "NCT02591355" - }, - { - "brief_title": "Study of Prophylactic Topical Dapsone 5% Gel Versus Moisturizer for Cetuximab-induced Papulopustular (Acneiform) Rash in Patients With mCRC or HNSCC Without Previous or Concurrent RT", - "phase": "Phase 3", - "drugs": "['Topical Dapsone 5% Gel', 'Moisturizer', 'oral antibiotics']", - "drugs_list": [ - "Topical Dapsone 5% Gel", - "Moisturizer", - "oral antibiotics" - ], - "diseases": "['Cetuximab-induced Papulopustular (Acneiform) Rash Who Have', 'Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma']", - "diseases_list": [ - "Cetuximab-induced Papulopustular (Acneiform) Rash Who Have", - "Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma" - ], - "enrollment": "11.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients 18 years or older with underlying diagnosis of metastatic colorectal cancer or head and neck squamous cell carcinoma including newly diagnosed patient \n\n Patients must provide written informed consent to participate in the study \n\n Anticipated initiation of cetuximab treatment with or without additional chemotherapy. \n\n Able to self-administer topical interventions or provide for another person to apply the topical interventions \n\n ", - "exclusion_criteria": ": \n\n Females of childbearing potential who are pregnant or nursing \n\n Patients with allergy, hypersensitivity or other contraindication to dapsone, sulfa antibiotics, or excipients of the dapsone gel product \n\n Patients with pre-existing dermatologic condition affecting the face and chest that would impair assessment of papulopustular rash including dense and/or long facial hair (per investigator discretion) \n\n Patients currently using prescription and/or over-the-counter topical medications to the face and/or chest who are unwilling to discontinue use during the trial intervention period (day 0 \u00b1 2 days through day 28 \u00b1 2 days) \n\n Previous or concurrent radiation therapy to head, neck, and chest (i.e. application sites only) \n\n Previous therapy with cetuximab within 6 months of consent", - "brief_summary": "The purpose of this study is to see if the investigators can prevent or reduce the severity of the Cetuximab-related acne rash. Two different topical agents will be applied to the skin. One topical agent is the dapsone gel and the other is a skin moisturizer. Dapsone gel is an FDA approved medication that you apply to the face. It is commonly used to treat acne. Skin moisturizers are recommended to patients who receive Cetuximab treatment. In addition to these topical agents they will be given a pill to take once a day. This pill has already been shown to help fight rashes from Cetuximab.", - "NCTID": "NCT01931150" - }, - { - "brief_title": "Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy", - "phase": "Phase 2", - "drugs": "['belimumab 10mg/kg', 'placebo']", - "drugs_list": [ - "belimumab 10mg/kg", - "placebo" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "93.0", - "inclusion_criteria": "inclusion criteria: \n\n 5 years to 17 years of age at enrollment \n\n Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria. \n\n Have active SLE disease (SELENA SLEDAI score \u2265 6). \n\n Have positive anti-nuclear antibody (ANA) test results. \n\n Are on a stable SLE treatment regimen at a fixed dose for a period of at least 30 days prior to Day 0. \n\n Females of childbearing age are willing to use appropriate contraception \n\n Subject age appropriate assent and parent or legal guardian informed consent to participate \n\n ", - "exclusion_criteria": ": \n\n Pregnant or nursing. \n\n Have received treatment with belimumab (BENLYSTA\u00ae) at any time. (BENLYSTA\u00ae is a registered trademark of the GSK group of companies.) \n\n Treatment with any B cell targeted therapy (for example, rituximab) or an investigational biological agent in the past year. \n\n Have received anti-TNF therapy; Interleukin-1 receptor antagonist; IVIG; or plasmapheresis within 90 days of Day 0. \n\n Have received high dose prednisone or equivalent (>1.5mg/kg/day) within 60 days of baseline. \n\n Have received intravenous (IV) cyclophosphamide within 60 days of Day 0. \n\n Have received any new immunosuppressive/immunomodulatory agent, anti-malarial agent within 60 days of baseline. \n\n Have severe lupus kidney disease. \n\n Have active central nervous system (CNS) lupus. \n\n Have had a major organ transplant. \n\n Have significant unstable or uncontrolled acute or chronic diseases or conditions not due to SLE. \n\n Have a planned surgical procedure. \n\n History of malignant neoplasm within the last 5 years. \n\n Have required management of acute or chronic infections in the past 60 days. \n\n Have current drug or alcohol abuse or dependence. \n\n Have a historically positive test, or test positive at screening for HIV, Hepatitis B, or Hepatitis C. \n\n Have an IgA deficiency. \n\n Have severe laboratory abnormalities. \n\n Have had anaphylactic reaction to X-ray contrast agents or biologic agents. \n\n Suicidal behavior or ideation. \n\n Children in Care(CiC): a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.", - "brief_summary": "This is a multi-center study to evaluate the safety, pharmacokinetics, and efficacy of belimumab intravenous (IV) in pediatric patients 5 to 17 years of age with active systemic lupus erythematosus", - "NCTID": "NCT01649765" - }, - { - "brief_title": "A Phase II Study of ACZONE\u2122 (Dapsone) Gel, 5% As a Treatment For Tarceva\u00ae (Erlotinib)Related Rash", - "phase": "Phase 2", - "drugs": "['ACZONE (dapsone) Gel, 5%', 'Vehicle Control']", - "drugs_list": [ - "ACZONE (dapsone) Gel", - "5%", - "Vehicle Control" - ], - "diseases": "['Rash', 'Non-small-Cell Lung Cancer']", - "diseases_list": [ - "Rash", - "Non-small-Cell Lung Cancer" - ], - "enrollment": "2.0", - "inclusion_criteria": "inclusion criteria: \n\n To be eligible for the study, subjects must fulfill all of the following criteria: \n\n Be male or female \u226518 years of age (inclusive). \n\n Have been prescribed Tarceva as a single agent to treat locally advanced or metastatic NSCLC, after failing at least 1 prior chemotherapy regimen. \n\n Present with acute signs and symptoms of rash on the face that meet the following criteria: \n\n Are suspected to be related to Tarceva, \n\n Include at least 3 inflammatory lesions, and \n\n Are less than CTCAE Grade 3 in severity. \n\n Have an Eastern Co-operative Oncology Group (ECOG) performance status \u22642 and a life expectancy of at least 4 months. \n\n Sign an approved informed consent form for the study. \n\n Be willing to comply with the protocol. \n\n ", - "exclusion_criteria": ": \n\n Subjects meeting any of the following criteria will be excluded from the study: \n\n A skin examination reveals the presence of another skin disease and/or condition (excessive facial hair, excessive scarring, sunburn, or other disfigurement) located on the face that, in the study physician's opinion, would confound the evaluation of the rash. \n\n A diagnosis of G6PD deficiency, defined as having a G6PD value below the lower limit of normal. \n\n A diagnosis of anemia, defined as hemoglobin <9.5 g/dL. \n\n Undergoing any current therapy for NSCLC other than Tarceva. \n\n Prior treatment with Iressa, Erbitux, or any experimental HER1/EGFR inhibitor. \n\n Treatment with topical antibiotics, topical steroids, and other topical treatments on the face within 14 days of Day 0 (start of ACZONE/placebo study treatment). \n\n Treatment with any systemic antibiotics within 7 days of Day 0 (start of ACZONE/placebo study treatment). \n\n Treatment with any systemic medication or therapy known to affect anti-inflammatory responses within 30 days prior to Day 0 (start of ACZONE/placebo study treatment). These medications include, but are not limited to, oral corticosteroids, cyclosporine, and methotrexate. Short-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs) before the study for non-rash related conditions is acceptable, provided that exposure is limited to \u22647 days per course. Chronic low-dose aspirin use is also acceptable. \n\n Active participation in an experimental therapy study or received experimental therapy within 30 days of Day 0 (start of ACZONE/placebo study treatment). \n\n A history of hypersensitivity to dapsone, sulfamethoxazole, trimethoprim, parabens, or any component of ACZONE. \n\n A poor medical risk because of other systemic diseases or active uncontrolled infections. \n\n Women who: are lactating; have a positive pregnancy test at Day 0, or; if sexually active and menstruating, are not practicing an adequate method of birth control. Acceptable methods of birth control include intrauterine device (IUD); oral, dermal (patch), implanted or injected contraceptives; tubal ligation or hysterectomy (medical documentation required); and/or barrier methods with spermicide. A surgically sterile partner is not considered an adequate method of birth control.", - "brief_summary": "The purpose of this study is to evaluate the safety and preliminary efficacy of ACZONE in subjects treated with the HER1/EGFR inhibitor Tarceva (erlotinib) who develop a rash on the face", - "NCTID": "NCT00343187" - }, - { - "brief_title": "Pilot Study to Assess Flares Following Inactivated Influenza Vaccine in Children With Systemic Lupus Erythematosus (SLE)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Systemic Lupus Erythematosus (SLE)']", - "diseases_list": [ - "Systemic Lupus Erythematosus (SLE)" - ], - "enrollment": "17.0", - "inclusion_criteria": "inclusion criteria: \n\n inclusion criteria: \n\n Subjects who meet the following criteria will be allowed to participate in the study: \n\n Complete immunization history must be available at time of enrollment \n\n Patients will be aged 8-18 years at time of enrollment \n\n Patient will have stable disease activity (no changes in SLEDAI >2 points) during the 3 months preceding enrollment. \n\n Patients can be enrolled as soon as the seasonal IIV is available and prior to the onset of influenza activity in the community. Generally this will be between September 2013-January2014. If feasible, enrollment will end in December 2013, which is usually before influenza circulates widely in the community. \n\n ", - "exclusion_criteria": ": \n\n Subjects who meet the following criteria will not be allowed to participate in the study: \n\n Females who are known to be pregnant or breastfeeding \n\n Moderate to high SLE disease activity at enrollment (SLEDAI >6) \n\n Oral temp \u2265100F (\u226537.8) within 72 hours prior to vaccination \n\n History of allergy to egg or egg products or history of allergic reaction to previous influenza vaccination or vaccine constituent \n\n History of Guillain-Barr\u00e9 syndrome after previous immunizations \n\n Unstable SLE disease activity during 3 months prior to enrollment (change in SLEDAI score >2) \n\n Requirement for high-dose IV Solumedrol and/or Cytoxan pulse therapy during 6 months prior to study \n\n Any condition that study site investigator deems would put patient at unacceptable risk of injury or render patient unable to meet requirements of the protocol. \n\n Received pre-medication with analgesic or antipyretic agents in the 6 hours prior to first vaccination, or planned medication with analgesic or antipyretic in the week following first vaccination. This criterion should not preclude subjects receiving such medication if the need arises. However, pre-medication is to be discouraged. \n\n Patient has received other inactivated vaccines within 14 days prior to administration of IIV. \n\n Patient is scheduled to receive another routinely administered inactivated vaccine within 14 days after IIV. \n\n Patient is currently participating in a study that involves and experimental agent (vaccine, drug, biologic, device, blood product, or medication), or expects to receive another experimental agent during participation in this study \n\n -", - "brief_summary": "This is an open label, pilot, observational, prospective study of the safety of inactivated influenza vaccine (IIV) in children with systemic lupus erythematosus (SLE) to be conducted during the 2013-2014 influenza season. The study will test conventional and novel biomarkers to assess disease flare and vaccine response and will also collect self-reported signs/symptoms in reactogenicity diaries during the 14 days after vaccination.", - "NCTID": "NCT02006784" - }, - { - "brief_title": "Effect of Hormone Replacement Therapy on Lupus Activity", - "phase": "Phase 4", - "drugs": "['Conjugated equine estrogens 0.625 mg/d + MPA 5 mg/d/10d']", - "drugs_list": [ - "Conjugated equine estrogens 0.625 mg/d + MPA 5 mg/d/10d" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "108.0", - "inclusion_criteria": "inclusion criteria: \n\n Eligible women will be those having any two of the following criteria \n\n Amenorrhea of 6 months or more. \n\n Serum follicle-stimulating hormone level of 30 IU/L or more. \n\n Menopausal symptoms. \n\n Age 48 years or older. \n\n ", - "exclusion_criteria": ": \n\n Women older than 65 years. \n\n Severe lupus activity at baseline (SLEDAI score, more than 30). \n\n Use of estrogens within 3 months of the screening visit. \n\n Serum creatinine of 2.0 mg/dL or more. \n\n Hypertriglyceridemia 500 mg/dL or more. \n\n Metabolic bone diseases. \n\n Liver disease. \n\n Untreated hyperthyroidism. \n\n Recent thrombosis. \n\n Malignancy. \n\n Endometrial hyperplasia. \n\n Undiagnosed uterine bleeding or cervical dysplasia", - "brief_summary": "Hypothesis, HRT does not increase the risk of lupus activity exacerbation, it is effective for the relief of menopausal symptoms and improves bone mineral density.~Double-blind, randomized, placebo controlled clinical trial.~Objectives~Determine the effect of HRT on disease activity, menopausal symptoms, bone mineral density, lipid profile, and mammographic parenchymal density in menopausal women with SLE.~Determine the incidence rate of major side effects of HRT in menopausal women with SLE.~Outcome Measures~Primary outcome will be global disease activity throughout the follow-up period.~Incidence of lupus flares, time to the first flare, changes in SLEDAI values from baseline at each follow-up visit, maximum disease activity, lupus treatment, hospitalizations, thromboses, and deaths.~Menopausal symptoms and depression will be assessed utilizing the Greene Climacteric Scale questionnaire and the Beck Depression Inventory.~Bone mineral density of lumbar spine and hip will be performed with dual energy x-ray absorptiometry. In addition, blood and urine samples to measure biochemical markers of bone turnover.~Estradiol levels, lipid profile,coagulation tests, cervical cytology examinations, mammography.~Inclusion Criteria: (Any two of the following criteria)~Amenorrhea of 6 months or more~Serum FSH level of 30 IU/L or more~Menopausal symptoms~Age 48 years or older.~Exclusion Criteria:~Women older than 65 years~Severe lupus activity at baseline~Use of estrogens within 3 months of the screening visit~Serum creatinine of 2.0 mg/dL or more~Hypertriglyceridemia 500 mg/dL or more~Metabolic bone diseases~Liver disease~Untreated hyperthyroidism~Recent thrombosis~Malignancy~Endometrial hyperplasia~Undiagnosed uterine bleeding~Cervical dysplasia.~Subject allocation Random assign, using a computer-generated randomization list to: Conjugated equine estrogens 0.625 mg/day plus 5 mg/day of medroxyprogesterone acetate p.o. for the first 10 days per-month, or biologically inert placebo.All women will receive 1200 mg of calcium carbonate and 800 IU of vitamin D, daily.~Follow-up procedure All patients will be evaluated by a rheumatologist and a reproductive health specialist at baseline,1,2,3,6,9,12,15,18,21, and 24 months.~Rheumatic evaluation:~General information (baseline).~Lupus activity (every visit).~Medications: (every visit)~Gynecological evaluation:~Onset of symptoms since the previous visit using a standardized questionnaire. In addition, a gynecological examination will be performed.~Criteria for early termination of the study:~A patient will be discontinued from the study whenever any of the following criteria would be present:~Development of severe lupus activity (SLEDAI > 30).~Development of any putative complication to hormone therapy.~Development of any other severe complications due neither to SLE nor hormone therapy.~Need prolonged immobilization.~Statistical analysis:~Between-group comparisons of lupus activity, maximum SLEDAI, and change in SLEDAI score from baseline at each follow-up visit. Incidence-density rates of flares with relative risk and 95 percent confidence intervals.Probability of flares throughout the study using life-table analyses and log-rank test.~Climacteric symptoms as the mean value of the Green's scale score at baseline and at each follow-up visit, between-group and intra-group. Bone mineral density as the mean value at baseline, 12 and 24 months, between and intra-group.~The proportion of patients in each group who develop secondary effects, as well as the number who quit the study during the follow-up period.~Continuous variables will be compared using Student's t-test, and categorical variables using chi-square or Fisher's exact test. Within-group comparisons will be done using the Wilcoxon signed-rank test. P values will be two-sided. Analyses will be conducted by the intention-to-treat method.", - "NCTID": "NCT00392093" - }, - { - "brief_title": "Efficacy and Safety Study of Eltrombopag in Pediatric Patients With Thrombocytopenia From Chronic Idiopathic Thrombocytopenic Purpura (ITP)", - "phase": "Phase 2", - "drugs": "['eltrombopag', 'Placebo']", - "drugs_list": [ - "eltrombopag", - "Placebo" - ], - "diseases": "['Purpura, Thrombocytopaenic, Idiopathic']", - "diseases_list": [ - "Purpura", - "Thrombocytopaenic", - "Idiopathic" - ], - "enrollment": "82.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects between 1 year and <18 years of age at Day 1. \n\n Written informed consent from subject's guardian and accompanying informed assent from subject (for children over 6 years old). \n\n Confirmed diagnosis of chronic ITP, according to the American Society of Hematology / British Committee for Standards in Haematology (ASH/BCSH) guidelines [George, 1996; BCSH, 2003]. In addition, a peripheral blood smear or bone marrow examination should support the diagnosis of ITP with no evidence of other causes of thrombocytopenia. \n\n Subjects who are refractory or have relapsed after at least one prior ITP therapy or are not eligible, for a medical reason, for other treatments. \n\n Day 1 (or within 48 hours prior) platelet count <30 Gi/L. \n\n Previous therapy for ITP with immunoglobulins (IVIg and anti-D) must have been completed at least 2 weeks prior to Day 1 or have been clearly ineffective. \n\n Subjects treated with concomitant ITP medication (e.g. corticosteroids or azathioprine) must be receiving a dose that has been stable for at least 4 weeks prior to Day 1. \n\n Previous treatment for ITP with splenectomy, rituximab and cyclophosphamide must have been completed at least 4 weeks prior to Day 1 or have clearly been ineffective. \n\n Subjects must have prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) within 80 to 120% of the normal range. \n\n Subjects must have a complete blood count (CBC) not suggestive of another hematological disorder. \n\n The following clinical chemistries for the subjects MUST NOT exceed the upper limit of normal (ULN) reference range by more than 20%: creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, and alkaline phosphatase. In addition, total albumin must not be below the lower limit of normal (LLN) by more than 10%. \n\n For subjects of child-bearing potential (after menarche): subject must not be sexually active or is practicing an acceptable method of contraception (documented in chart). Female subjects (or female partners of male subjects) must use one of the following highly effective methods of contraception (i.e., Pearl Index <1.0%) from two weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study: \n\n Complete abstinence from intercourse; \n\n Intrauterine device (IUD); \n\n Two forms of barrier contraception (diaphragm plus spermicide, and for males condom plus spermicide); \n\n Systemic contraceptives (combined or progesterone only). \n\n ", - "exclusion_criteria": ": \n\n Any clinically relevant abnormality, other than ITP, identified on the screening examination or any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study or suggests another primary diagnosis (e.g. thrombocytopenia is secondary to another disease). \n\n Concurrent or past malignant disease, including myeloproliferative disorder. \n\n Subjects who are not suitable for continuation of their current therapy for at least 7 additional additional weeks. \n\n Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding Day 1. \n\n History of platelet agglutination abnormality that prevents reliable measurement of platelet counts. \n\n Diagnosis of secondary immune thrombocytopenia, including those with laboratory or clinical evidence of HIV infection, anti-phospholipid antibody syndrome, chronic hepatitis B infection, hepatitis C virus infection, or any evidence of active hepatitis at the time of subject screening. \n\n Subject with Evans syndrome (autoimmune thrombocytopenia and autoimmune hemolysis). \n\n Subjects with known inherited thrombocytopenia (e.g. MYH-9 disorders) \n\n Subjects treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for >3 consecutive days within 2 weeks of Day 1. \n\n Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist. \n\n For female subjects who have reached menarche status, an inability or unwillingness to provide a blood or urine specimen for pregnancy testing. \n\n Female subjects who are pregnant or lactating.", - "brief_summary": "Phase II, multi-center, 3 part, staggered cohort, open-label and double blind, randomized, placebo controlled study involving 3 age-determined cohorts (Cohort 1: between 12 and 17 years old; Cohort 2: between 6 and 11 years old; Cohort 3: between 1 and 5 years old). Daily dosing with eltrombopag will begin with 5 patients in the oldest age cohort in an open label fashion, and a review of safety, pharmacokinetic and platelet count data will be performed regularly. If no safety concerns are identified after 12 weeks, 18 additional patients will be randomised to placebo or eltrombopag (2:1 randomisation). After 7 weeks of randomized treatment, all patients will receive eltrombopag in an open label fashion. The total duration of treatment with eltrombopag will be 24 weeks. If at the time of the aforementioned 12 week review of the first 5 patients no safety issues are identified, dosing will begin in the next lower age cohort with an initial group of 5 patients. The same procedure will be followed in terms of safety review and subsequent enrolment and randomisation of the additional patients. Initiation of the younger age cohort will take place once data from the previous has been evaluated. Doses will be adjusted according to platelet counts and tolerability. The study will include a review of the safety data by a Data Safety Monitoring Board.", - "NCTID": "NCT00908037" - }, - { - "brief_title": "Safety, Tolerability and Efficacy Study of Doxycycline Foam for the Prevention of EGFRI Skin Toxicity in Cancer Patients", - "phase": "Phase 2", - "drugs": "['FDX104 (4% Doxycycline)']", - "drugs_list": [ - "FDX104 (4% Doxycycline)" - ], - "diseases": "['Rash Due to Epidermal Growth Factor Receptor Inhibitors']", - "diseases_list": [ - "Rash Due to Epidermal Growth Factor Receptor Inhibitors" - ], - "enrollment": "24.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 years and older \n\n Subjects with any cancer receiving Cetuximab or Panitumumab on a weekly or every 2 weeks basis. \n\n Scheduled to start Cetuximab or Panitumumab treatment; \n\n Males or non-pregnant, non-lactating females who are postmenopausal, naturally or surgically sterile, or with a negative subunit hCG pregnancy test immediately prior to study entry. \n\n Able to understand and provide signed informed consent. \n\n Ability to reliably apply topical FDX104 and vehicle twice a day to the appropriate part of the face \n\n Willingness to minimize sun exposure for 5 weeks from randomization \n\n ECOG performance status 0-2. \n\n ", - "exclusion_criteria": ": \n\n Prior allergic reaction or severe intolerance to Doxcycycline and/or other tetracyclines. \n\n Prior allergic reaction or severe intolerance to soy or coconut oil \n\n Cutaneous metastases on the face or might spread to the face. \n\n The presence of any active skin disease (e.g., eczema), tattoos or other problems at application site, (i.e., located on the face) that, in the investigator's opinion, could confound the evaluation of the rash or make topical application unacceptable \n\n Hair on the face (e.g beard) which would interfere with the application of the study drug or its evaluation. \n\n ANC <1,500/mm3 (or<1.5x109/L), or Platelet count < 100,000/mm3 (or <100x109/L) \n\n Abnormal renal functions: Serum creatinine >1.6 mg/dL or 142umol/L (SI units) or calculated estimated creatinine clearance <40 ml/min1.73 m2 based on Cockcroft and Gault formula. \n\n Abnormal hepatic functions: Serum Aspartate transaminase (AST) or alanine tansaminase (ALT) >5 institutional upper limit of normal (ULN). Or Total billirubin > 2 x institutional ULN or >5 x institutional ULN if documented liver metastasis. \n\n Any clinically significant safety laboratory results that, in the opinion of the Investigator, would place the subject at undue risk if the subject were to participate in the study \n\n Any clinically significant finding on the physical examination that, in the opinion of the Investigator, would place the subject at undue risk if the subject were to participate in the study \n\n Systemic lupus erythematosus \n\n Undergoing any current biological treatment for cancer other than the prescribed EGFRI \n\n Treatment with topical antibiotics, anti-acne medication and other topical treatments on the face within 14 days prior to treatment start. Use of topical corticosteroids within 2 weeks prior to baseline; only mild to moderate topical steroids are allowed outside the head and neck area. The area should not exceed 10% of the whole body surface area. In body folds, such as axillary and inguinal regions, only mild topical steroids are allowed in short term use (\u226415 consecutive days). \n\n Treatment with systemic antibiotics 7 days prior to treatment start. \n\n Known or suspected pregnancy, or lactation or planned pregnancy (females) \n\n Previous enrolment in a clinical trial involving investigational drug or a medical device within 30 days before provision of written informed consent for the study \n\n Subjects who are mentally or physically unable to comply with all aspects of the study.", - "brief_summary": "The purpose of this study is to evaluate the safety, tolerability and efficacy of FDX104 Antibiotic Foam in the prevention of EGFRI skin toxicity in cancer patients receiving Cetuximab or Panitumumab.", - "NCTID": "NCT02239731" - }, - { - "brief_title": "Minoxidil 1% for Eyebrow Enhancement", - "phase": "Phase 4", - "drugs": "['Minoxidil lotion 1%', 'Placebo']", - "drugs_list": [ - "Minoxidil lotion 1%", - "Placebo" - ], - "diseases": "['Eyebrow Hypotrichosis', 'Thin Eyebrow']", - "diseases_list": [ - "Eyebrow Hypotrichosis", - "Thin Eyebrow" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n male or female aged 18-60 years \n\n hypotrichosis of eyebrows \n\n healthy \n\n informed consent obtained \n\n ", - "exclusion_criteria": ": \n\n underlying diseases \n\n alopecia areata or trichotillomania \n\n thyroid diseases \n\n pregnancy or breast feeding \n\n previous eyebrow tattoo, trauma or accident. \n\n history of eyebrow or hair medications in 6 months \n\n history of minoxidil or its ingredient allergy \n\n history of eyebrow surgery.", - "brief_summary": "The purpose of the study is to compare efficacy and safety of minoxidil 1% versus placebo in enhancement of eyebrows.", - "NCTID": "NCT01924000" - }, - { - "brief_title": "A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)", - "phase": "Phase 3", - "drugs": "['CNTO 148 (Golimumab)', 'Placebo', 'Methotrexate']", - "drugs_list": [ - "CNTO 148 (Golimumab)", - "Placebo", - "Methotrexate" - ], - "diseases": "['Juvenile Idiopathic Arthritis']", - "diseases_list": [ - "Juvenile Idiopathic Arthritis" - ], - "enrollment": "173.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis must have been before the patient's 16th birthday \n\n Disease duration of at least 6 months before study entry \n\n Must have 5 or more joints with active arthritis \n\n Must be taking a stable dose of methotrexate 10-30 mg/meter squared (patients with body surface area [BSA] 1.67 square meter or more must be taking a minimum of 15 mg/week of methotrexate) \n\n May take a stable dose of prednisone less than 10 mg/day 4 weeks prior to entry or may take a stable dose of NSAIDS (non-steroidal anti-inflammatory drugs) 2 weeks prior to entry \n\n Must have qualifying laboratory values at the first visit. \n\n ", - "exclusion_criteria": ": \n\n Have known allergies, hypersensitivity, or intolerance to golimumab or similar therapeutics \n\n Are pregnant or breast-feeding, or planning a pregnancy or fathering a child within 6 months after the last study agent administration \n\n Have initiated DMARDS and/or immunosuppressive therapy within 4 weeks prior to study initiation", - "brief_summary": "The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to methotrexate.", - "NCTID": "NCT01230827" - } - ], - "1": [ - { - "brief_title": "Duke Lupus Registry", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Systemic Lupus Erythematosus', 'Cutaneous Lupus']", - "diseases_list": [ - "Systemic Lupus Erythematosus", - "Cutaneous Lupus" - ], - "enrollment": "1000.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of Systemic Lupus Erythematosus or Cutaneous Lupus \n\n Patient of a rheumatologist at Duke University Medical Center \n\n ", - "exclusion_criteria": ": \n\n Inability to travel to Duke for follow-up visits \n\n Inability to speak English \n\n Not able to provide informed consent", - "brief_summary": "Lupus is a systemic autoimmune disease that can present with many varied symptoms, including joint pain, fevers, kidney disease, and rashes. Lupus can affect anyone, but it is most common in younger women.~The Duke Lupus Registry will collect information and blood samples from patients with lupus (systemic lupus erythematosus or cutaneous lupus) seen in the Duke Rheumatology clinics. The goal of this Registry is to understand how lupus changes over time so that we can improve the treatment of patients with lupus.", - "NCTID": "NCT00512694" - }, - { - "brief_title": "An Investigation of NNC 0151-0000-0000 in Subjects With Systemic Lupus Erythematosus (SLE)", - "phase": "Phase 1", - "drugs": "['NNC 0151-0000-0000', 'placebo']", - "drugs_list": [ - "NNC 0151-0000-0000", - "placebo" - ], - "diseases": "['Inflammation', 'Systemic Lupus Erythematosus']", - "diseases_list": [ - "Inflammation", - "Systemic Lupus Erythematosus" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of systemic lupus erythematosus (SLE) \n\n Disease duration: 6 months or longer \n\n Stable, mild to moderately active systemic lupus erythematosus (SLE) \n\n Receiving stable maintenance therapy \n\n ", - "exclusion_criteria": ": \n\n Significant Lupus Nephritis \n\n Active central nervous system (CNS) disease \n\n Significant arterial or venous thrombosis (blood clots) within 12 months prior to trial start \n\n Body weight of 260 lbs/120 kg or more \n\n History of alcohol or substance abuse \n\n History of cancer \n\n Infections \n\n Viral infections: HIV, Hepatitis B or C, Epstein-Barr Virus (EBV), Cytomegalovirus (CMV), Varicella-Zoster Virus (VZV), or Herpes Simplex Virus (HSV-1 or HSV-2) \n\n Tuberculosis \n\n Severe systemic bacterial, viral or fungal infections within the past 12 months prior to trial start \n\n Immunosuppressive and immune modulating therapy", - "brief_summary": "This trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and signs of bioactivity of increasing repeated doses of NNC 151-0000-0000 in subjects with Systemic Lupus Erythematosus (SLE).", - "NCTID": "NCT01018238" - }, - { - "brief_title": "Memantine in Systemic Lupus Erythematosus", - "phase": "", - "drugs": "['Memantine', 'Placebo']", - "drugs_list": [ - "Memantine", - "Placebo" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "61.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of SLE \n\n Self-reported cognitive impairment \n\n ", - "exclusion_criteria": ": \n\n Age < 18 years. \n\n History of non-compliance \n\n Pregnancy \n\n Liver or renal insufficiency/failure (calculated creatinine clearance < 50 cc/min) \n\n Severe SLE flare in the last 6 weeks (defined as SLEDAI > 12 points) \n\n Recent (within 4 weeks) change in any medication relevant to cognitive function, including prednisone, anti-depressants, medications for insomnia, narcotic medications, attention deficit disorder medications \n\n Current alcohol or illicit drug abuse \n\n Current use of Namenda, Aricept, Provigil", - "brief_summary": "Neuropsychiatric manifestations of Systemic Lupus Erythematosus (NPSLE) are both common and an important source of morbidity. Of the case definitions for NPSLE syndromes that have recently been developed, cognitive dysfunction appears to be the most prevalent. A novel mechanism is that a subset of SLE patients with cognitive dysfunction have antibodies in the NR2 glutamate receptor. We propose, in a double -blind placebo-controlled trial, to determine whether SLE patients, with or without the NR2 glutamate receptor antibody, have significant improvement using memantine, an inhibitor of the NMDA receptor.", - "NCTID": "NCT00181298" - }, - { - "brief_title": "Exploratory Study of Changes in Disease Activity and Biomarkers With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus (SLE)", - "phase": "Phase 2", - "drugs": "['paquinimod (ABR-215757)']", - "drugs_list": [ - "paquinimod (ABR-215757)" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "13.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 18 years at the time of signing the informed consent form \n\n Fulfil at least 4 criteria for SLE as defined by the American College of Rheumatology (ACR) \n\n Present with active SLE disease with at least one of the following symptoms: \n\n i) Arthritis - > 2 joints with pain and signs of inflammation (i.e. tenderness, swelling, or effusion) ii) Inflammatory-type skin rash iii) Oral ulcers \n\n Laboratory values as follows \n\n Hemoglobin \u2265 100 g/L \n\n Absolute neutrophil count \u2265 1.0 x 109/L \n\n Total bilirubin \u2264 1.5 x upper limit of normal (ULN) \n\n AST (SGOT) / ALT (SGPT) \u2264 2.5 x ULN \n\n Ability to take and retain oral medication \n\n Ability to sign and date a written informed consent prior to entering the study \n\n Willingness and ability to comply with the protocol for the duration of the study \n\n ", - "exclusion_criteria": ": \n\n Active severe SLE flare with central nervous system (CNS) manifestations, active renal lupus, systemic vasculitis, active pericarditis, active pleuritis, active peritonitis or other SLE manifestations requiring treatment not allowed by the study protocol. \n\n Severe renal impairment (estimated or measured GFR <50%) \n\n Oral treatment with corticosteroids (>15 mg/day prednisolone or equivalent) or changes in corticosteroid dosing within 30 days prior to the first dose of study medication. This also includes intraarticular steroid injections or topical treatment for SLE symptoms. Inhaled or topical steroids may be given for reasons other than SLE disease activity (such as asthma, contact dermatitis) as clinically indicated. \n\n Intravenous corticosteroids within 3 months prior to the first dose of study medication. \n\n Intravenous cyclophosphamide within 6 months prior to the first dose of study medication. \n\n Treatment with anti-rheumatic/immunosuppressive drugs within 3 months prior to first dose of study medication, other than the following medications at stable doses: methotrexate (\u226425 mg/week), azathioprine (\u22642.5 mg/kg/day), hydroxychloroquine and mycophenolate mofetil (\u22643000 mg/day). \n\n B-cell depletion therapy (such as treatment with Rituximab) within 12 months prior to the first dose of study medication. \n\n Potent inhibitors or inducers of CYP3A4 intravenously or orally within 14 days prior to first dose of study medication. \n\n History of myocardial infarction or current uncontrolled angina, severe uncontrolled ventricular arrhythmias, symptomatic congestive heart failure, unstable angina pectoris, or electrocardiographic evidence of acute ischemia. \n\n Marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval >450 milliseconds \n\n History of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome) \n\n Treatment with concomitant medications that prolong the QT interval. \n\n History of, or current, ischemic CNS disease. \n\n Current malignancy. A 5-year cancer-free period is required with the exception of skin basal or squamous cell carcinoma or cervical cancer in situ that has been excised. \n\n Current severe infection \n\n Positive result on screening for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV) antibodies. \n\n Drug abuse. \n\n Major surgery within 3 weeks prior to study entry. \n\n Known or suspected hypersensitivity to ABR-215757 or excipients. \n\n Female subject of child-bearing potential who is not using a medically accepted safe method of contraception. All female subjects of child-bearing potential must have a negative urine pregnancy test at the Screening and Baseline Visits. As interaction studies between ABR-215757 and oral contraceptives have not yet been performed, women using the contraceptive pill must also use a complementary contraceptive device, i.e. barrier method, during the treatment period and for at least 1 month thereafter. \n\n Female subject of child-bearing potential who is pregnant or lactating. \n\n Simultaneous participation or participation within 4 months or 5 half lives (whichever is longer) prior to study entry in any other study involving investigational drugs or other experimental therapy. \n\n Other significant, unstable medical disease not related to SLE that in the investigator's opinion would confound the study result or put the patient at risk. \n\n Patients likely to receive oral or intravenous steroids or immunosuppressant for other non-SLE condition during the study duration, as this will confound the study result. \n\n Vaccination within 4 weeks prior to the first dose of study medication.", - "brief_summary": "This is an exploratory open label single arm study to evaluate changes in disease activity and biomarkers in patients with mild active SLE, during treatment with ABR-215757 given as add-on to standard therapy. To be eligible for the study SLE patients should present with symptoms from skin, mouth and/or joints. After a screening period of one week patients will be treated with ABR-215757 for 12 weeks. The initial dose of ABR-215757 will be 1.5 mg/day. There will be an option to increase the dose to 3.0 mg/day following 28 days of treatment. Follow-up visits will take place 4 weeks and 8 weeks after last day of treatment. Disease activity during treatment will be studied using the Systemic Lupus Erythematosus disease Activity Index (SLEDAI-2K) as well as organ system specific disease activity indexes (CLASI for skin involvement and number of swollen/tender joints using 28- and 66/68-joint counts). At specified time points during the study, blood samples and biopsies will be collected for analysis of established and exploratory biomarkers of SLE. Concomitant SLE treatment allowed include: prednisolone or equivalent at a dose of \u226415 mg/day, hydroxychloroquine, azathioprine, methotrexate and mycophenolate mofetil, all at stable doses from specified timepoints prior to the study and throughout the study.", - "NCTID": "NCT00997100" - }, - { - "brief_title": "GENetic & Immunologic Abnomalies in Systemic Lupus Erythematosus", - "phase": "", - "drugs": "['Blood sampling']", - "drugs_list": [ - "Blood sampling" - ], - "diseases": "['Systemic Lupus Erythematosus (SLE)']", - "diseases_list": [ - "Systemic Lupus Erythematosus (SLE)" - ], - "enrollment": "271.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female subject, major or minor of any age with SLE (defined according to the ACR criteria) \n\n Onset pediatric (<18 years) OR \n\n Syndromic Lupus (associated with growth retardation, neurological deficit not related to lupus, frostbite, lymphoproliferation, the kidney malformations, heart, lung, brain calcifications) OR \n\n Lupus in context with familial consanguinity OR \n\n Familial cases (2 cases of SLE related first degree relative) OR related topic of the first degree to a lupus patient participant (if family lupus or related parents) OR \n\n mother/father's lupus patient (in cas of simplex lupus) \n\n A person or beneficiary entitled to a social security scheme or similar \n\n Informed consent signed by the person (or parent / holding parental authority for minors) \n\n ", - "exclusion_criteria": ": \n\n - none", - "brief_summary": "Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease for which the aetiology includes genet-ic and environmental factors. It is rare in children as compared to adults. The severity may be related to greater involvement of genetic factors in children. The impact of genetics in the development of SLE is important, and the risk of recurrence in siblings evaluated by lambda S ratio is 30 in SLE, while it is 15 for type-1 diabetes and 8 rheumatoid arthritis, thereby indicating high impact of genetics in SLE.~Recently, the group of Professor Yanick Crow in Manchester and other teams has identified new forms of lupus Mendelian genetics. The TREX1 and genes involved in the SAMHD1 frostbite lupus.~Nearly 2 % of all adult subjects with SLE have a heterozygous mutation in the TREX1 gene, which therefore represents the first genetic cause of SLE. The team of Professor Crow also identified the ACP5 gene that is responsible for SLE associated with Spondylo-epiphyseal enchondro-epiphyseal dysplasia (syndromic lupus). Other groups have identified mutations in two genes encoding a DNAse (DNAse1 and DNAse1L3) responsible for familial monogenic forms of SLE. These new genes SLE were identified through research of germ-line mutations in cases of lupus syndromic or family. In collaboration with Professor Crow, we are currently undergoing characterization of a novel gene of SLE in a family and we have identified a second locus identified in another family. The identification of these genes provides a better understanding of the mechanisms regulating immune tolerance in humans. The frequency of these genetic forms is not known. There is very little data on the immunological phenotype of these patients.~This is a clinical study to investigate the genetic and immunological abnormalities associated with pediatric SLE. The aim are to:~study the genetics of pediatric SLE (or syndromic or family) and to search for mutations in the known genetic lupus or new genes in collaboration with Professor Yanick Crow.~study the lymphocyte subpopulations and serum cytokines in pediatric patients with SLE (or syndromic or family) in the large Rh\u00f4ne- Alpes- Auvergne area.", - "NCTID": "NCT01992666" - }, - { - "brief_title": "Cutaneous Lupus Erythematosus and Elidel", - "phase": "", - "drugs": "['Elidel (pimecrolimus)']", - "drugs_list": [ - "Elidel (pimecrolimus)" - ], - "diseases": "['Lupus Erythematosus, Cutaneous', 'Lupus Erythematosus, Discoid']", - "diseases_list": [ - "Lupus Erythematosus", - "Cutaneous", - "Lupus Erythematosus", - "Discoid" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects may be included only if they fulfil the following inclusion criteria on the pre-treatment days (between Day -14 and Day -2) and on Day 1 (before first application of study medication): \n\n Female and male patients aged 18-65 years (females of childbearing potential may be enrolled provided they are routinely using adequate contraception in the assessment of the investigator). \n\n Patients with histologically defined dLE or scLE. \n\n The test sites (lupus erythematosus plaques) must be on the face only, and have a total sign score of 4 or more (sum of erythema, induration and scaling scores) and must be the same within a given patient (ie not differing in the sum for erythema, induration or scaling). Each of the 2 test sites must be at least 3 cm apart. \n\n The patients must receive a baseline medication with chloroquine. \n\n Patients must have been informed about the study procedures and medication and must have given their written Informed Consent. \n\n Patients expected to be available for the duration of the study and able to comply with the study visits. \n\n ", - "exclusion_criteria": ": \n\n Any of the following criteria will disqualify a patient from participating in this study: \n\n Systemic therapy for lupus erythematosus within one month prior to first application of study medication in this study (steroids, retinoids, herbal medicines, etc) except chloroquine. \n\n Patients with systemic lupus erythematosus or patients whose chronic discoid lupus erythematosus appears to be spontaneously flaring or improving based on the experience of the investigator. \n\n Patients who are receiving oral medication, known to precipitate lupus lesions (e.g. procainamide, diuretics, piroxicam, beta blockers, griseofulvin, lithium and other psychotropic drugs). \n\n Topical therapy [i.e. corticosteroids, etc.] within 2 weeks prior to first application of study medication. \n\n Patients with clinically significant medical conditions which could interfere with the conduct of the study. This includes: \n\n Renal impairment (creatinine > 2.0 mg/dl) \n\n Hepatic impairment (liver function test values above notable abnormalities; g-GT, ALAT, ASAT: 2x the upper limit) \n\n Haematologic disorders (haemoglobin, platelet, erythrocyte and leukocyte counts above notable abnormalities) \n\n Neurologic disorders (significant impairment of sensory and motor function as judged by the investigator) \n\n Patients known to be previously immunocompromised (e.g. lymphoma, AIDS, myelodysplastic disorders) or treated recently with immunosuppressive drugs or treatment (e.g. radiation therapy or chemotherapy). HIV tests are not necessary. \n\n Patients with clinically relevant cardio-vascular diseases (New York Heart Association [NYHA] III or IV) \n\n Patients who suffer from systemic or generalized infections (bacterial, fungal, viral) \n\n Patients with malignancy or history of malignancy. \n\n Patients who suffer from acute or chronic bacterial, viral, or fungal skin diseases. However, patients with tinea pedum and/or onychomycosis can be included. Likewise, only patients with acute herpes lesions are excluded. \n\n Patients with a history of drug or alcohol abuse during the past 1 year. \n\n Patients with known hypersensitivity to any of the ingredients of the study medication or to tacrolimus (the investigator will be provided with a list of ingredients of the study medication). \n\n Patients who have received an investigational drug within 4 weeks prior to the first application of the study medication. \n\n Patients who are unwilling or unable to provide Informed Consent or to participate satisfactorily for the entire trial period. \n\n Any other condition which, in the opinion of the investigator, would render the patient ineligible for the study.", - "brief_summary": "This trial evaluates the therapeutic effect of Elidel (pimecrolimus) in comparison to the corresponding vehicle in patients with chronic discoid lupus erythematosus (dLE) or subacute cutaneous lupus erythematosus (scLE).", - "NCTID": "NCT00222183" - }, - { - "brief_title": "Safety Study of Two Vaccine Strategies in Patients With Systemic Lupus Erythematosus", - "phase": "Phase 2; Phase 3", - "drugs": "['Prevenar\u00ae and Pneumo23\u00ae', 'Placebo, Pneumo23\u00ae']", - "drugs_list": [ - "Prevenar\u00ae and Pneumo23\u00ae", - "Placebo", - "Pneumo23\u00ae" - ], - "diseases": "['Lupus Erythematosus, Systemic']", - "diseases_list": [ - "Lupus Erythematosus", - "Systemic" - ], - "enrollment": "47.0", - "inclusion_criteria": "inclusion criteria: \n\n age 18 to 65 years \n\n SLE as defined by the ACR classification \n\n Stable SLE (treatment not modified during the 2 months preceding the inclusion date W0) \n\n SLE treated by immunosuppressant only or systemic corticosteroids at a dose \u2265 5 mg/j or systemic corticosteroids at any dose associated with one or more immunosuppressive drugs \n\n SLE treated by hydroxychloroquine only \n\n 31 months following \n\n females must have an effective method of contraception during the first 7 months of the study and with a negative serum or urinary pregnancy test \n\n females not wishing to have a child during the 7 months following W0 \n\n physical examination \n\n signed written and informed consent \n\n ", - "exclusion_criteria": ": \n\n pregnant females or females wishing to have a child during the 7 months following W0 \n\n subjects infected with HIV and/or HBV( Ag HBs+) and or HVC \n\n medical history of allergy to any vaccine component \n\n receipt of any pneumococcal vaccine less than 5 years \n\n receipt of other vaccine within one month prior to enrolment (inclusion visit W0) \n\n receipt of immunoglobulin within three months prior to enrolment (inclusion visit W0) \n\n splenectomy \n\n hematopoietic disorders which give contra-indications to intramuscular and hypodermic route injections, \n\n active malignancy , cirrhosis \n\n intercurrent illness within one month prior to enrolment (inclusion visit W0) \n\n patients under biotherapy (anti-CD20)must not been included if the interval between vaccination and the end of the biotherapy is less than one year. \n\n participation to another clinical study during the first 7 months of the study \n\n subject not covered by Health Insurance", - "brief_summary": "The aim of this study is to compare the immunological efficacy of two pneumococcal vaccination strategies in patients with systemic lupus erythematosus (SLE) treated with corticosteroids associated or not with other immunosuppressive drugs : 1) a prime-boost strategy using vaccination with conjugate vaccine (Prevenar\u00ae) at week 0 and Poly Saccharidic vaccine (Pneumo23\u00ae) after 6 months (W24)2) compared to the standard vaccination with Poly Saccharidic vaccine (Pneumo23\u00ae) at W24 after placebo at W0", - "NCTID": "NCT00611663" - }, - { - "brief_title": "Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE)", - "phase": "Phase 2", - "drugs": "['Mycophenolate Mofetil', 'Hydroxychloroquine or Chloroquine', 'Prednisone']", - "drugs_list": [ - "Mycophenolate Mofetil", - "Hydroxychloroquine or Chloroquine", - "Prednisone" - ], - "diseases": "['Systemic Lupus Erythematosus', 'SLE']", - "diseases_list": [ - "Systemic Lupus Erythematosus", - "SLE" - ], - "enrollment": "102.0", - "inclusion_criteria": "inclusion criteria: \n\n Able and willing to give written informed consent and comply with requirements of the study; \n\n Age 18 - 70 years, inclusive, at randomization; \n\n Diagnosis of SLE, per the American College of Rheumatology (ACR) criteria; \n\n m-SLEDAI score < 4 at screening visit (SLEDAI score without serologies); \n\n Physician Global Assessment (0-3) score of 1 or less at screening visit; \n\n On a stable dose of MMF (1000-3000 mg/day) for at least 12 weeks prior to randomization; \n\n Total duration of stable or decreasing MMF therapy must be at least: \n\n two years for subjects initiating MMF for renal indications (with or without concurrent extra-renal manifestations), or \n\n one year for subjects initiating MMF for extra-renal indications. \n\n If the subject is on prednisone or other corticosteroid, the following criteria must be met: \n\n the dose may not exceed 10 mg/day (or its equivalent) for the 12 weeks prior to randomization; however, temporary (up to 4 total days) increases, not to exceed 20mg/day, are permitted; \n\n the dose must be held stable for the four weeks prior to randomization (no temporary increases within 4 weeks of randomization are permitted). \n\n If the subject has a history of B cell depleting therapy within the past 3 years, presence of CD19 positive cells must be documented within 12 weeks prior to screening; \n\n On maintenance HCQ or chloroquine at a stable dose for at least 12 weeks prior to randomization. \n\n ", - "exclusion_criteria": ": \n\n A history of life-threatening neuropsychiatric SLE within 1 calendar year prior to randomization; \n\n Any of the following laboratory abnormalities at the screening visit: \n\n Proteinuria as defined by a spot protein/creatinine ratio > 1.0 mg/mg; \n\n Serum creatinine > 2.0 mg/dL; \n\n Transaminases > 2.5x the upper limit of normal (ULN); \n\n Hemoglobin < 9 g/dL, unless the subject has documented hemoglobinopathy; \n\n White blood count (WBC) < 2000/mm^3 (equivalent to < 2 x10^9/L); \n\n Neutrophils < 1000/mm^3 (equivalent to < 1 x10^9/L); or \n\n Platelet count < 75,000/mm^3 (equivalent to < 75 x 10^9/L). \n\n Prednisone > 25 mg/day (or its equivalent) within 24 weeks prior to randomization for lupus activity; \n\n Concomitant immunosuppressants including but not limited to azathioprine, methotrexate, 6-mercaptopurine, leflunomide, calcineurin inhibitors, anti-tumor necrosis factor agents within 12 weeks prior to randomization; \n\n Plasmapheresis or IV immunoglobulin within 12 weeks prior to randomization; \n\n Cyclophosphamide therapy within 24 weeks prior to randomization; \n\n Concomitant therapy with belimumab within 24 weeks prior to randomization; \n\n B cell depleting therapy within two calendar years of randomization; \n\n Experimental therapy within the 24 weeks, or five half-lives of the agent, whichever is longer, prior to randomization; \n\n Solid organ or stem cell transplantation; \n\n Identified definitive diagnosis of another autoimmune disease that may require immunosuppression for treatment, including but not limited to: rheumatoid arthritis, scleroderma, primary Sjogren's syndrome, primary vasculitis, psoriasis, multiple sclerosis, ankylosing spondylitis, and inflammatory bowel disease. \n\n Chronic infections including, but not limited to, human immunodeficiency virus (HIV), active tuberculosis (TB), currently receiving therapy)), hepatitis B or hepatitis C, or latent systemic fungal infection; \n\n At or within 12 weeks of screening: \n\n a history of or current positive purified protein derivative (PPD) (> 5 mm induration regardless of prior Bacillus Calmette-Gu\u00e9rin (BCG) vaccine administration) or positive QuantiFERON unless documentation exists of completion of at least one month of prophylaxis for latent TB or completed treatment for active TB; or \n\n an indeterminate QuantiFERON\u00ae unless followed by a subsequent negative PPD or negative QuantiFERON. \n\n History of malignancy within the last five years, except for resected basal or squamous cell carcinoma, treated cervical dysplasia, or treated in situ cervical cancer Grade I; \n\n Pregnant or lactating, or intention to pursue pregnancy within three months after the completion of the study; \n\n Unable or unwilling to use reliable methods of contraception, as outlined in the Mycophenolate REMS (e.g., Risk Evaluation and Mitigation Strategy), from four weeks prior to randomization to 6 weeks after completion of the study. This criterion applies to females of reproductive potential. (Reference: Mycophenolate REMS, Program Resources and Educational Materials, Information for Patients, What are my birth control options? Access the link at: (https://www.mycophenolaterems.com/PatientOverview.aspx). \n\n Drug or alcohol abuse within one calendar year of randomization; \n\n Other medical or psychiatric conditions that the investigator feels would place the subject at special risk by participation in this protocol.", - "brief_summary": "This trial seeks to describe the effect of withdrawal from mycophenolate mofetil (MMF) on risk of clinically significant disease reactivation in quiescent SLE patients who have been on long-term MMF therapy.", - "NCTID": "NCT01946880" - }, - { - "brief_title": "BG9588 (Anti-CD40L Antibody) to Treat Lupus Nephritis", - "phase": "Phase 2", - "drugs": "['BG9588']", - "drugs_list": [ - "BG9588" - ], - "diseases": "['Glomerulonephritis, Membranoproliferative', 'Lupus Nephritis']", - "diseases_list": [ - "Glomerulonephritis", - "Membranoproliferative", - "Lupus Nephritis" - ], - "enrollment": "20.0", - "inclusion_criteria": "Must give written informed consent prior to any testing under this protocol. \n\n Must be 18 years or older, inclusive, at the time of informed consent. \n\n Must have a renal biopsy showing active WHO Class III, IV, or mixed membranous and proliferative SLE GN, within the 5 years prior to the first dose of study drug. \n\n Must have proteinuria of greater than or equal to 1.0 g/day at both the Day-27 and day-13 evaluations. \n\n Must fulfill any one the following four criteria, at each of the two screening visits (i.e., Day-27 and Day-13): \n\n Anti-dsDNA antibody greater than 2x the upper limit of normal (ULN). \n\n C3 complement less than 80 mg/dL. \n\n Hematuria greater than 5 rbc/hpf. \n\n Urinary granular or red blood cell casts. \n\n Must not have any medical disorder, which in the opinion of the investigator, should exclude the subject from this study. \n\n Must not have prior arterial or venous thrombosis, or history of recurrent abortion (3 or more), in the presence of anti-cardiolipin antibodies. \n\n Must not have a chest x-ray with evidence of active infection or neoplasm within the 6 months prior to the first dose of study drug. \n\n Must not have rapidly progressive glomerulonephritis, defined as a doubling of serum creatinine, within the 3 months prior to the first dose of study drug. \n\n Must not have fibrinoid necrosis and/or cellular crescents affecting more than 25 percent of glomeruli in any renal biopsy performed within the 3 months prior to the first dose of study drug. \n\n Must not have clinically significant findings for any of the following within the 4 weeks prior to the first dose of study drug: active psychiatric disease, serum creatinine greater than 2.0 mg/dL, prothrombin time (PT) greater than 1.3x control (in the absence of coumadin therapy; abnormal PT values due to anti-coagulation therapy are allowed if within the therapeutic range), AST or ALT levels greater than 3x normal, other major organ dysfunction, or serious local or systemic infection (e.g., pneumonia, septicemia). \n\n Must not be positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HVC Ab), or HIV antibody at the Day-27 evaluation. \n\n Must not have a mean CD4 count less than or equal to 300 microliters (mean of Day-27 and Day-13 results). \n\n Must not have treatment with an antibody or other investigational drug within the 3 months prior to the first dose of the study drug. \n\n Must not have any vaccination within the 4 weeks prior to the first dose of the study drug. \n\n Must not have treatment with IV or oral cyclophosphamide within the 4 weeks prior to the first dose of the study drug. \n\n Must not have treatment with any of the following medications within the 4 weeks prior to the first dose of study drug: IV methylprednisolone, cyclosporine or related compound, or oral prednisone (equivalent oral glucocorticoid) at a dose greater than 0.5 mg/kg/day. \n\n Must not have initiation of treatment with ACE inhibitors within the 4 weeks prior to the first dose of study drug. \n\n Must not have initiation of treatment with azathioprine, methotrexate or mycophenolate mofetil within the 4 weeks prior to the first dose of study drug. \n\n Must not have treatment with any new oral or new IV antibiotic within the 2 weeks prior to the first dose of study drug. Subjects on prophylactic antibiotics are permitted to continue these during the study. \n\n Female subjects, unless post-menopausal or surgically sterile, must use an adequate method of contraception. \n\n Women must not be currently breast-feeding. \n\n Must not have a positive pregnancy test in any evaluation prior to the first dose of study drug. \n\n Must not be currently enrolled in any other study in which the subject is receiving any type of drug or non-drug therapy. \n\n Must not have been previously dosed with BG9588.", - "exclusion_criteria": "", - "brief_summary": "The purpose of this study is to investigate whether the experimental drug BG9588 can be used to treat lupus nephritis more effectively and with less toxicity than standard treatments, including cyclophosphamide (Cytoxan), azothioprine (Imuran) and prednisone.~The body's immune system naturally produces antibodies to fight foreign substances like bacteria and viruses. In autoimmune diseases like lupus, however, the body makes antibodies that attack its own tissues, causing inflammation and organ damage. Lupus antibodies attack and damage kidney cells. BG9588 can interfere with the production of these antibodies, and therefore, may lessen kidney damage in people with lupus nephritis.~This study will look at: how BG9588 enters and leaves the blood and body tissue over time; adverse effects of the drug; and whether treatment with BG9588 can result in less kidney damage than other therapies.~Study patients will be receive a 30-minute infusion of BG9588 into a vein every two weeks for three doses and then once every 28 days for four doses. Patients' steroid dosage may be tapered; individual adjustments will be made as required.~Patients screened for the study will undergo a physical examination, medical history, various blood and urine tests, as well as complete a quality of life questionnaire. Results of a previous kidney biopsy and chest X ray are also required. Many of these tests will be repeated throughout the study.~In a previous animal study, BG9588 treatment of mice with lupus nephritis improved their disease and survival.", - "NCTID": "NCT00001789" - }, - { - "brief_title": "Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone", - "phase": "Phase 2", - "drugs": "['Abatacept', 'Placebo', 'Prednisone', 'Abatacept']", - "drugs_list": [ - "Abatacept", - "Placebo", - "Prednisone", - "Abatacept" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "183.0", - "inclusion_criteria": "inclusion criteria: \n\n participants must be diagnosed with SLE and be experiencing an active lupus flare in at least one of three organ systems: skin (discoid lesions), inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints within 14 days of a screening visit (arthritis) \n\n Stable dose of prednisone (<30mg) for at least one month \n\n ", - "exclusion_criteria": ": \n\n participants experiencing an active lupus flare in the kidney or central nervous systems \n\n Treatment with a stable dose of azathioprine, mycophenolate mofetil, hydroxychloroquine, chloroquine, or methotrexate for less than three months prior to the study \n\n participants with active viral or bacterial infections \n\n participants with any other autoimmune disease as a main diagnosis \n\n Prior treatment with rituximab", - "brief_summary": "The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, in patients with active lupus flares in at least one of three organ systems: skin (discoid lesions); inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints (arthritis). All participants will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.", - "NCTID": "NCT00119678" - }, - { - "brief_title": "Autoimmunity in Sisters of Lupus Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "817.0", - "inclusion_criteria": "Sister Diagnosed with SLE: \n\n inclusion criteria: \n\n Proband must be a female and have documented SLE that meets ACR criteria. SLE must be diagnosed by and including age 40. \n\n Proband must have at least one biological sister \u2265 10 years of age and \u2264 45 who is available and willing to donate a blood sample and enroll in a longitudinal study. Both full and half siblings qualify. \n\n ", - "exclusion_criteria": ": \n\n If inclusion criteria above are met for the proband, there are no exclusions. \n\n Sister who does not have SLE: \n\n inclusion criteria: \n\n Female with a full or half sister who has been documented SLE that meets ACR criteria. \n\n Sister must be currently between ages \u2265 10 and \u2264 45 at the time of enrollment and not have a diagnosis of SLE. \n\n Sister must be able to complete questionnaires and should be willing to donate a blood sample at baseline and follow-up. \n\n Sister should communicate to the recruiter that she is willing to be followed for a period of at least two years by phone and/or internet. \n\n ", - "brief_summary": "This study enrolled over 400 unaffected sisters of young women diagnosed with SLE. These unaffected sisters are being followed with an annual health questionnaire (CSQ) and blood sample.", - "NCTID": "NCT01076101" - }, - { - "brief_title": "Atacicept Demonstrating Dose RESponSe", - "phase": "Phase 2", - "drugs": "['Placebo', 'Atacicept', 'Atacicept', 'Atacicept', 'Atacicept']", - "drugs_list": [ - "Placebo", - "Atacicept", - "Atacicept", - "Atacicept", - "Atacicept" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female of \u226518 years of age \n\n Written informed consent \n\n Diagnosis of SLE satisfying at least 4 out of the 11 ACR criteria during the course of their illness \n\n Disease duration of at least 6 months \n\n SLEDAI-2K score \u2265 6 at screening \n\n Positive test results for antinuclear antibody (ANA) (HEp-2 ANA \u22651:80) and/or anti-double-stranded deoxyribonucleic acid (dsDNA) (\u226530 IU/mL) at screening \n\n Negative serum pregnancy test and highly effective method of contraception for woman of childbearing potential. \n\n ", - "exclusion_criteria": ": \n\n Increase in dosing of corticosteroids within 2 weeks prior to screening \n\n Introduction of MMF within 3 months prior to TD1 or increase in dosing within 1 month before screening \n\n Change in dosing of immunosuppressants or corticosteroids during the screening period \n\n Serum IgG < 6g/L \n\n Estimated Glomerular Filtration Rate (GFR) <50 mL/min/1.73m\u00b2 \n\n Urinary protein:creatinine ratio >2 mg/mg \n\n History of demyelinating disease \n\n Breastfeeding or pregnancy \n\n Legal or limited legal capacity \n\n Additional ", - "brief_summary": "Systemic lupus erythematosis (SLE) is an autoimmune disease, meaning that the body's immune system attacks its own organs and tissues. Within the immune system, B-cells and plasma cells make proteins called antibodies, which in autoimmune disease can bind to one's own tissues and are thus referred to as autoantibodies. Atacicept blocks 2 factors in the body, called BLyS and APRIL, which are important for the maintenance of B-cells and plasma cells, and thus the production of antibodies. This study will assess whether treatment with atacicept can reduce SLE disease activity. Atacicept is still an experimental drug, meaning that it is not available outside of a clinical trial, and that its potential benefits and risks have not been fully determined.~A total of 175 subjects are planned to be randomized (35 subjects per treatment arm) in a 1:1:1:1:1 ratio to receive either atacicept 5 mg, atacicept 25 mg, atacicept 75 mg, atacicept 115 mg or matching placebo, given subcutaneously once weekly for 24 weeks.~The primary objective of the trial is to evaluate the efficacy of atacicept compared to placebo in reducing SLE disease activity in subjects treated with standard of care (SoC) therapy and to investigate the dose-response relationship.~The secondary objectives of the trial are:~To evaluate the effect of atacicept in reducing corticosteroid usage~To evaluate the safety and tolerability profile of atacicept in subjects with SLE~To confirm the PK and PD profiles of atacicept in SLE subjects~To evaluate the changes in the Medical Outcomes Study Short Form General Health Survey [SF-36].", - "NCTID": "NCT01440231" - }, - { - "brief_title": "Myfortic Versus Azathioprine in Systemic Lupus Erythematosus", - "phase": "Phase 3", - "drugs": "['switch to Myfortic', 'continuation of azathioprine']", - "drugs_list": [ - "switch to Myfortic", - "continuation of azathioprine" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria: \n\n Males or females, aged 18 years and over \n\n Patients meeting the diagnostic criteria for SLE (Appendix 2), according to ACR guidelines (including screening for anti-dsDNA (antibody to native DNA in abnormal titer)) \n\n SLEDAI > 6 \n\n Patients treated with maintenance therapy including azathioprine. \n\n Patients who are willing and able to participate in the study and from whom written informed consent has been obtained \n\n ", - "exclusion_criteria": ": \n\n Creatinine clearance of < 20ml/min \n\n Patients with any clinically significant infection \n\n Patients with known hypersensitivity to myfortic \u00ae or to drugs with similar chemical structures \n\n Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin \n\n Patients with SLE active CNS manifestations or a past history of SLE CNS complications (e.g. psychosis, grand mal seizures) \n\n Patients who have received prior therapy with mycophenolic acids (MPAs) (e.g. MMF) \n\n Patients who have received an investigational drug within four weeks prior to study entry \n\n Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception", - "brief_summary": "This study is designed to explore the use of myfortic \u00ae in patients with active lupus erythematosus. Similar drugs in this class are increasingly used in organ transplantation and in autoimmune diseases. With the established safety profile of myfortic \u00ae in allo-transplantation and the already existing data of mycophenolate mofetil in autoimmune diseases, this study should help to demonstrate the beneficial effect of myfortic \u00ae on lupus activity. The aim of the study will be to show a decreased disease activity with myfortic \u00ae compared to standard maintenance therapy with azathioprine.", - "NCTID": "NCT00504244" - }, - { - "brief_title": "Synergetic B-cell Immodulation in SLE", - "phase": "Phase 2", - "drugs": "['Rituximab with belimumab']", - "drugs_list": [ - "Rituximab with belimumab" - ], - "diseases": "['Lupus Erythematosus, Systemic']", - "diseases_list": [ - "Lupus Erythematosus", - "Systemic" - ], - "enrollment": "16.0", - "inclusion_criteria": "inclusion criteria: \n\n age 18 years, \n\n American College of Rheumatology (ACR) diagnosis of SLE (1997 revised criteria, see appendix 1) \n\n Severe SLE flare at screening (see also section 5.2.3.2.), defined as a situation in which 1 or more of the following criteria are met: \n\n Increase in SLEDAI (SLE Disease Activity Index) with 12 or more points \n\n New or worse SLE-related activity of major organs, i.e.: central nervous system (CNS-) SLE (includes NPSLE), vasculitis, nephritis, pericarditis and/or myocarditis, myositis, thrombocytopenia < 60, hemolytic anemia < 4.4mmol/L (=7.0g/dL). \n\n Refractory disease, defined as persisting or progressive disease activity (SLEDAI > 6 points) despite conventional immunosuppressive treatment and 1 or more of the following criteria: \n\n failure of the initial induction treatment at six months, for which a switch to another induction therapy regime has already been carried out; \n\n intolerance or contraindication for cyclophosphamide and mycophenolate mofetil (MMF); \n\n exceeding a cumulative dose of 15 gram of cyclophosphamide; \n\n a second relapse within two years after start of the initial induction therapy \n\n a relative contraindication for high-dose oral or intravenous (iv) prednisone, such as avascular osteonecrosis, previous psychosis on corticosteroids, osteoporosis and/or severe obesity (BMI =35 kg/m2). \n\n ANA seropositivity, as defined by a positive ANA-titer = 1:80, before and at screening : \n\n Positive test results from 2 independent time points within the study screening period; OR \n\n One positive historical test result and 1 positive result during the screening period. Historical documentation of a positive test of ANA (eg, ANA by HEp-2 titer, ANA by ELISA) must include the date of the test. \n\n Anti-DNA seropositivity, as defined by a positive anti-dsDNA serum antibody = 30 IU/mL, before and at screening: \n\n Positive test results from 2 independent time points within the study screening period. \n\n One positive historical test result and 1 positive result during the screening period. Historical documentation of a positive test of anti-dsDNA (eg, anti-dsDNA by Farr assay or ELISA) must include the date of the test. \n\n Immune-complex mediated complement usage, as defined by: \n\n a low C3 serum level = 0.9 g/L; OR \n\n a low C4 serum level = 95 mg/L; OR \n\n a reduced activation of the classical pathway < 75% \n\n Use of effective contraception \n\n ", - "exclusion_criteria": ": \n\n Active pregnancy, as proven by a positive urine beta-HCG (human chorionic gonadotropin) test or a positive serum beta-HCG \n\n Significant B-cell depletion (peripheral B-cell counts < 60x10E6) \n\n Significant hypogammaglobulinemia (IgG < 8.0 g/L) \n\n Immunization with a live vaccine 1 month before screening \n\n Active infection at time of screening, as follows: \n\n Hospitalization for treatment of infection within previous 2 months of day 0 of the study \n\n Use of parenteral (intravenous of intramuscular) antibiotics ( including anti-bacterial, anti-viral, anti-fungal or anti-parasitic agents) within previous 2 months of day 0 of the study", - "brief_summary": "The present study investigates the potential of a new therapeutic approach in lupus nephritis combining rituximab (anti-CD20) and belimumab (anti-BAFF). The main goal of the study is to assess the reduction (and seroconversion) of pathogenic autoantibodies, to evaluate clinical improvement and assess the safety and feasibility of long-term B-cell depletion.", - "NCTID": "NCT02284984" - }, - { - "brief_title": "The Reduction of Systemic Lupus Erythematosus Flares :Study PLUS", - "phase": "Phase 4", - "drugs": "['versus hydroxychloroquine']", - "drugs_list": [ - "versus hydroxychloroquine" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "543.0", - "inclusion_criteria": "inclusion criteria: \n\n Age of 18 and above \n\n Diagnosis of Systemic Lupus Erythematosus (SLE) according to the American College of Rheumatology (ACR) Classification Criteria. \n\n Treatment with HCQ for at least 6 months, without modification of HCQ dosage for 2 months \n\n Stable dosage of HCQ from one day to another (200 g x 2/day or 400 mg once a day or 200 mg once a day) \n\n No increase in the steroids dosage during the 3 previous weeks \n\n Steroids dosage lower or equal to 0. 5 mg/kg/day of prednisone equivalent \n\n No modifications of a possible immunosuppressor during the 2 previous months \n\n SELENA-SLEDAI < or = 12 \n\n Signature of the consent of participation \n\n ", - "exclusion_criteria": ": \n\n Known retinopathy, present or passed \n\n Severe cataract obstructing the ophthalmologic monitoring \n\n MONOPHTALM patients \n\n Past history of intolerance with HCQ (in particular gastro-intestinal, or retinal) during the possible former use of a higher dosage \n\n Use of nivaquine during the 3 previous months \n\n Treatment with biotherapy (for example Rituximab) during the 12 previous months \n\n Calculated clearance of creatinin lower than 60 ml/min \n\n Chronic alcoholism \n\n Liver failure \n\n Desire of pregnancy in the next 7 months \n\n Known non compliance, and risks of random follow-up \n\n Absence of social security cover \n\n People profiting from a particular protection: \n\n Pregnant women \n\n Age under 18 \n\n Patient under supervision and TRUSTEESHIP \n\n People who are hospitalized without their consent and not protected by the law \n\n People who are private of freedom. \n\n Criteria of inclusion at the visit of randomization (D0): \n\n All the patients responding to the next criterions can be randomized: \n\n Blood HCQ concentration ranging between 100 and 750 ng/ml at the time of the visit of preselection, \n\n No increase in the steroids dosage since last visit \n\n No modifications of a possible immunosuppressor since last visit \n\n SELENA-SLEDAI < or = 12 Activity of the lupus remaining stable (no increase of more than 2 points of the SELENA-SLEDAI), \n\n Ophthalmologic examination in the 6 previous months with no contra-indication for the use of HCQ, \n\n Absences of conductive disorders on the ECG \n\n Use of an effective contraception, \n\n Negative Beta-HCG.", - "brief_summary": "The main objective of study PLUS is to determine the potential benefits of individualized HCQ dosing schedules aimed at maintaining the whole-blood HCQ concentration above 1000 ng/ml", - "NCTID": "NCT00413361" - }, - { - "brief_title": "Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis", - "phase": "Phase 2; Phase 3", - "drugs": "['Corticosteroids (prednisone or prednisolone)', 'Abatacept', 'Abatacept', 'Mycophenolate mofetil (MMF)', 'Abatacept']", - "drugs_list": [ - "Corticosteroids (prednisone or prednisolone)", - "Abatacept", - "Abatacept", - "Mycophenolate mofetil (MMF)", - "Abatacept" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "423.0", - "inclusion_criteria": "inclusion criteria: \n\n Systemic Lupus Erythematosus (SLE) as defined by meeting at least 4 of the 11 classification criteria of the American College of Rheumatology for the classification of Systemic Lupus Erythematosus, either sequentially or coincident. The 4 criteria need not be present at study entry \n\n Renal biopsy within 12 months prior to screening visit indicating active proliferative lupus glomerulonephritis (met ISN/RPS Class III or IV classification criteria [2003], excluding Class III [C], IV-S [C] and IV-G [C], or the World Health Organization Class III or IV classification criteria [1982], excluding Class IIIc, IVd). If the renal biopsy was performed >3 months but \u226412 months prior to screening visit, at least 1 of the following 3 serologies (performed locally) must have been abnormal prior to screening visit: complement (C3 or C4) level below normal range OR anti-dsDNA >upper limit of normal range. \n\n A stable serum creatinine \u22643 mg/dL \n\n ", - "exclusion_criteria": ": \n\n Subjects with a rise in serum creatinine of \u22651 mg/dL within 1 month prior to the screening visit \n\n Subjects with drug-induced SLE, as opposed to idiopathic SLE \n\n Subjects with severe, unstable and/or progressive Central nervous system (CNS) lupus \n\n Subjects with autoimmune disease other than SLE as their main diagnosis (e.g.; Rheumatoid arthritis (RA), Multiple Sclerosis [MS]) \n\n Subjects who have received treatment with cyclophosphamide within 3 months of randomization (Day 1). \n\n Subjects who have received treatment with rituximab < 6 months prior to the screening visit", - "brief_summary": "The purpose of this clinical research study is to learn if addition of abatacept is safe and improves the effectiveness of treatment of patients with active lupus nephritis who are also taking mycophenolate mofetil (MMF) and corticosteroids.", - "NCTID": "NCT00430677" - }, - { - "brief_title": "Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis", - "phase": "Phase 3", - "drugs": "['prednisolone', 'Placebo']", - "drugs_list": [ - "prednisolone", - "Placebo" - ], - "diseases": "['Lupus Nephritis']", - "diseases_list": [ - "Lupus Nephritis" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria: \n\n age at least 18 years \n\n diagnosis of SLE by ACR criteria \n\n diagnosis of proliferative lupus nephritis (ISN/RPS class III or IV) \n\n currently on prednisolone (5 to 20 mg/day) \n\n in partial or complete remission for at least 3 months \n\n ", - "exclusion_criteria": ": \n\n currently pregnant \n\n in end-stage renal failure \n\n receiving corticosteroids for an indication other than lupus nephritis", - "brief_summary": "There is debate as to whether long-term low-dose steroids such as prednisolone help to suppress relapses of systemic lupus erythematosus (SLE) in patients who are in remission from their lupus nephritis. If low-dose prednisolone reduces relapses, these beneficial effects may be counter-balanced by the long-term side-effects associated with prednisolone. This pilot study will determine the feasibility of conducting a larger randomized control trial that will answer the question of whether or not long-term low-dose prednisolone (5 - 7.5 mg/day) reduces the flares of SLE in patients with previous lupus nephritis.", - "NCTID": "NCT00539799" - }, - { - "brief_title": "Lupus Cohort--Thrombotic Events and Coronary Artery Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cardiovascular Diseases', 'Coronary Disease', 'Thrombosis', 'Heart Diseases', 'Lupus Erythematosus, Systemic']", - "diseases_list": [ - "Cardiovascular Diseases", - "Coronary Disease", - "Thrombosis", - "Heart Diseases", - "Lupus Erythematosus", - "Systemic" - ], - "enrollment": "", - "inclusion_criteria": "No eligibility criteria", - "exclusion_criteria": "", - "brief_summary": "To study longitudinally the incidence, pathogenesis, and risk factors for thrombotic events and coronary artery disease in a cohort of patients with systemic lupus erythematosus (SLE).", - "NCTID": "NCT00005436" - }, - { - "brief_title": "Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry", - "phase": "", - "drugs": "['BENLYSTA', 'SLE treatment']", - "drugs_list": [ - "BENLYSTA", - "SLE treatment" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "3138.0", - "inclusion_criteria": "inclusion criteria: \n\n Males or females age 18 years or older. \n\n Have a clinical diagnosis of active SLE. \n\n Current or history of autoantibody-positive SLE. \n\n Must be treated with SLE therapy including BENLYSTA and/or immunosuppressants (for example, azathioprine, methotrexate, cyclophosphamide, mycophenolate, and biologics). \n\n Have the ability to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures. \n\n ", - "exclusion_criteria": ": \n\n Treatment with an investigational drug within one year of enrollment. Investigational drug applies to any drug not approved for sale in the country it is being used. \n\n Currently enrolled in a placebo-controlled BENLYSTA (belimumab) clinical trial or a continuation protocol where belimumab is used as an investigational agent. \n\n Participants who have a history of BENLYSTA exposure, but are not currently receiving BENLYSTA. \n\n Participants only receiving an anti-malarial for SLE. \n\n Participants only receiving steroids for SLE.", - "brief_summary": "The purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in participants with active, autoantibody-positive SLE treated with and without BENLYSTA (belimumab). Participants will be enrolled into 1 of 2 cohorts: (1) BENLYSTA cohort: participants receiving or initiating BENLYSTA plus standard of care (SOC) at Baseline; (2) comparison cohort: participants not receiving BENLYSTA but receiving SOC at Baseline. After enrollment, changes in lupus medications, including starting or stopping BENLYSTA, are at the discretion of the physician, and all participants will continue to be followed regardless of changes in their lupus medicines until study completion. All participants will be assessed for AESI including serious infections, opportunistic infections and other infections of interest, malignancies, selected serious psychiatric events and mortality. Data will be collected at enrollment and at 6 month intervals for 5 years. BENLYSTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.", - "NCTID": "NCT01729455" - }, - { - "brief_title": "Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus", - "phase": "Phase 2", - "drugs": "['BT063', 'Placebo']", - "drugs_list": [ - "BT063", - "Placebo" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "36.0", - "inclusion_criteria": "inclusion criteria: \n\n Eligible male and female subjects, Age \u2265 18 and \u2264 75 years with Body mass index \u2265 18 and \u2264 35 kg/m2 at screening visit \n\n Diagnosed SLE (defined by \u2265 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE) for at least 3 months before screening \n\n Moderate to severe SLE disease activity demonstrated by SLEDAI-2K total score \u2265 6, including skin and joint involvement \n\n CLASI Activity score \u2265 5 or at least 5 of 66/68 joints with pain and signs of inflammation \n\n Positive anti-nuclear antibodies (ANA) test at screening \n\n No change in concomitant medication for SLE activity maintenance and symptom control regarding type of medication and dose level for at least 8 weeks prior to baseline (for steroids and NSAIDs/pain medication 2 weeks) \n\n Normal electrocardiogram (ECG) \n\n ", - "exclusion_criteria": ": \n\n Active, severe neuropsychiatric SLE defined as any neuropsychiatric element scoring BILAG level A disease or lupus nephritis \n\n Diagnosed psoriasis \n\n Presence or history of malignancy within the previous 5 years \n\n Systemic antibiotic treatment within 2 weeks before baseline visit \n\n A positive diagnosis for viral hepatitis B or hepatitis C or Human immunodeficiency virus (HIV) or tested positive for tuberculosis as assessed or recent infection with Herpes Zoster or Herpes Simplex (Type 1 and Type 2), Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection or reactivation at screening \n\n Clinically significant hematologic abnormalities attributed to SLE: Haemoglobin < 8 g/dL; Platelets < 50 E9/L; Leucocytes < 2.0 E9/L \n\n Active or history of inflammatory bowel disease (including active or history of colitis) \n\n Received the following medications: - Rituximab within the last 48 weeks before screening - Belimumab within the last 12 weeks before screening - IV immunoglobulin (Ig) within the last 12 weeks before screening - Intramuscular (IM) or intra-articular glucocorticosteroids within the last 4 weeks before screening - IV cyclophosphamide within the last 6 months before screening - IV glucocorticosteroids (pulse therapy) within the last 6 months before screening \n\n Pregnant or nursing women or women who intend to become pregnant \n\n Known intolerance to immunoglobulins or comparable substances (e.g., significant vaccination reaction) \n\n Known intolerance to proteins of human origin \n\n History of clinically significant drug or alcohol abuse within the last 12 months", - "brief_summary": "The purpose of this study is to evaluate the safety and efficacy of repeated intravenous infusions of the study drug BT063 in patients with Systemic Lupus Erythematosus (SLE) compared with people who receive a placebo.", - "NCTID": "NCT02554019" - }, - { - "brief_title": "Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE)", - "phase": "Phase 1; Phase 2", - "drugs": "['Cyclophosphamide', 'Fludarabine', 'Tacrolimus', 'Mycophenolate Mofetil', 'Rabbit antithymocyte globulin', 'Total body irradiation', 'Allogeneic bone marrow transplant']", - "drugs_list": [ - "Cyclophosphamide", - "Fludarabine", - "Tacrolimus", - "Mycophenolate Mofetil", - "Rabbit antithymocyte globulin", - "Total body irradiation", - "Allogeneic bone marrow transplant" - ], - "diseases": "['Lupus Erythematosus', 'Graft-versus-host Disease']", - "diseases_list": [ - "Lupus Erythematosus", - "Graft-versus-host Disease" - ], - "enrollment": "1.0", - "inclusion_criteria": "inclusion criteria: \n\n Four or more American College of Rheumatology (ACR) criteria for the classification of SLE or 4 or more of the SLICE criteria \n\n Involvement of one or more of the following organ systems: renal, neurologic, hematologic, cardiac, pulmonary, gastrointestinal \n\n A lack of response to corticosteroids in moderate-to-high doses, and to either an equivalent degree of immunosuppression with azathioprine, methotrexate, cyclosporin, tacrolimus, belimumab, rituximab, mycophenolate mofetil, and/or appropriate other treatment \n\n Patients should be eligible for transplantation according to the BMT Policy Manual \n\n ", - "exclusion_criteria": ": \n\n Age less than 18 years and over 75 years \n\n Any risk of pregnancy \n\n Patients who are preterminal or moribund", - "brief_summary": "The main goal of the study is to determine if bone marrow transplant (BMT) from a less specific pool of donors in combination with high dose cyclophosphamide can induce remission of refractory systemic lupus erythematosus.", - "NCTID": "NCT02080195" - }, - { - "brief_title": "A Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV Lupus Nephritis", - "phase": "Phase 3", - "drugs": "['Rituximab', 'Placebo', 'Mycophenolate mofetil', 'Methylprednisolone', 'Diphenhydramine', 'Acetaminophen', 'Prednisone']", - "drugs_list": [ - "Rituximab", - "Placebo", - "Mycophenolate mofetil", - "Methylprednisolone", - "Diphenhydramine", - "Acetaminophen", - "Prednisone" - ], - "diseases": "['Lupus Nephritis']", - "diseases_list": [ - "Lupus Nephritis" - ], - "enrollment": "144.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of systemic lupus erythematosus (SLE) according to current American College of Rheumatology (ACR) criteria. \n\n Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis (LN), with either active or active/chronic disease. \n\n Proteinuria. \n\n 16-75 years of age. \n\n ", - "exclusion_criteria": ": \n\n Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE. \n\n Unstable subjects with thrombocytopenia experiencing or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions. \n\n Lack of peripheral venous access. \n\n Pregnancy or lactation. \n\n History of severe allergic or anaphylactic reactions to monoclonal antibodies. \n\n Significant or uncontrolled medical disease in any organ system not related to SLE or LN, which, in the investigator's opinion, would preclude subject participation. \n\n Concomitant chronic conditions, excluding SLE (eg, asthma, Crohn's disease) that require oral or systemic corticosteroid use in the 52 weeks prior to screening. \n\n History of renal transplant. \n\n Known human immunodeficiency virus (HIV) infection. \n\n Known active infection of any kind (but excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous anti-infectives within 4 weeks of randomization or oral anti-infectives within 2 weeks of randomization. \n\n History of deep space infection within 1 year of screening. \n\n History of serious recurrent or chronic infection. \n\n History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ (except basal cell carcinomas of the skin that have been treated or excised and have resolved). \n\n Currently active alcohol or drug abuse or history of alcohol or drug abuse within 52 weeks prior to screening. \n\n Major surgery requiring hospitalization within 4 weeks of screening (excluding diagnostic surgery). \n\n Treatment with cyclophosphamide or calcineurin inhibitors within the 90 days prior to screening. \n\n Use of mycophenolate mofetil (MMF) at a dose of > 2 grams daily for longer than the 90 days prior to screening. \n\n Intolerance or history of allergic reaction to MMF. \n\n Intolerance or history of allergic reaction to both angiotensin-converting enzyme (ACE) inhibitors and angiotensin-receptor blockers. \n\n Use of oral prednisone (or corticosteroid equivalent) at a dose of > 20 mg/day for longer than the 14 days prior to screening. \n\n Previous treatment with CAMPATH-1H (alemtuzumab). \n\n Previous treatment with a B-cell targeted therapy. \n\n Treatment with any investigational agent (including biologic agents approved for other indications) within 28 days of the start of the screening period or 5 half-lives of the investigational drug (whichever is longer). \n\n Receipt of a live vaccine within the 28 days prior to screening. \n\n Intolerance or contraindication to oral or IV corticosteroids. \n\n Current therapy with a nonsteroidal anti-inflammatory agent. \n\n Positive hepatitis B sAg or hepatitis C serology.", - "brief_summary": "This was a Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab in combination with mycophenolate mofetil (MMF) compared with placebo in combination with MMF in subjects diagnosed with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis.", - "NCTID": "NCT00282347" - }, - { - "brief_title": "Aspirin Resistance in Systemic Lupus Erythematosus (SLE)", - "phase": "Phase 1", - "drugs": "['aspirin and meloxicam']", - "drugs_list": [ - "aspirin and meloxicam" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "70.0", - "inclusion_criteria": "inclusion criteria: \n\n Written Informed consent. \n\n Age >18 yrs. \n\n SLE meeting ACR criteria {Tan, Cohen, et al. 1982 1482 /id} for at least 6 months.(SLE group) \n\n Stable disease activity as evidenced by no change in immunosuppressive therapy in the past 1 month. \n\n If female of childbearing potential must use an effective method of birth control \n\n ", - "exclusion_criteria": ". \n\n Renal disease (creatinine >1.5 mg/dL, dialysis, 2+ or more proteinuria) \n\n Previous or current history of peptic ulcer disease or gastrointestinal bleed. \n\n Previous or current thromboembolic or ischemic cardiovascular event (stroke, myocardial infarction, angina) - can do aspirin part of study. \n\n Currently taking an anticoagulant or antiplatelet agent (besides aspirin). \n\n Thrombocytopenia (platelet count <135,000) \n\n Pregnancy \n\n Allergy to aspirin, NSAIDs \n\n NSAIDs in the previous week", - "brief_summary": "This study examine whether patients with lupus respond to aspirin , and if not, if that is related to inflammation. We examine the ability of aspirin to inhibit the production of thromboxane in patients with lupus and controls and see if aspirin insensitive thromboxane production is inhibited by meloxicam.", - "NCTID": "NCT00731302" - }, - { - "brief_title": "Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)", - "phase": "Phase 4", - "drugs": "['Mycophenolate mofetil', 'sugar pill']", - "drugs_list": [ - "Mycophenolate mofetil", - "sugar pill" - ], - "diseases": "['Systemic Lupus Erythematosus', 'Atherosclerosis']", - "diseases_list": [ - "Systemic Lupus Erythematosus", - "Atherosclerosis" - ], - "enrollment": "71.0", - "inclusion_criteria": "inclusion criteria: \n\n Female SLE patients \n\n Age 18-60 years \n\n If premenopausal using a reliable method of contraception \n\n Clinically stable disease \n\n Taking hydroxychloroquine and up to 15mgs of prednisolone daily \n\n ", - "exclusion_criteria": ": \n\n Smokers \n\n Pregnancy or breast feeding \n\n Use of other immunosuppressants (hydroxychloroquine and stable dose of prednisolone up to 15 mgs daily will be permitted) \n\n Use of any investigational drug within 1 month prior to screening \n\n Acute infections 2 weeks prior to Visit 1 \n\n History of ischaemic heart disease or end stage renal disease \n\n Current signs or symptoms of severe, progressive or uncontrolled hepatic, haematological, gastroenterological, endocrine, pulmonary, cardiac or neurological disease", - "brief_summary": "Systemic lupus erythematosus (SLE) is an independent risk factor for atherosclerosis. Endothelial dysfunction is the earliest marker of atherosclerosis and is measured by flow mediated dilation (FMD) of the brachial artery. The purpose of the study was to measure FMD in mild, stable SLE patients and look for change in FMD with the immunosuppressant drug mycophenolate mofetil (MMF).", - "NCTID": "NCT01101802" - }, - { - "brief_title": "Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE)", - "phase": "Phase 2", - "drugs": "['Low Dose Mesenchymal Stem Cells (MSCs)', 'High Dose Mesenchymal Stem Cells (MSCs)', 'Placebo Infusion']", - "drugs_list": [ - "Low Dose Mesenchymal Stem Cells (MSCs)", - "High Dose Mesenchymal Stem Cells (MSCs)", - "Placebo Infusion" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "81.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients between 18 and 65 years old, male or female, of any race \n\n Historical presence of at least 4 of 11 of the ACR Classification Criteria \n\n Evidence of a positive ANA (\u22651:80 titer) or positive dsDNA antibody test within 6 months of screening \n\n Clinically active SLE determined by SLEDAI score \u22656 and the presence of at least one BILAG A or BILAG B at screening, despite standard-of-care therapy \n\n If the patient has a BILAG A or BILAG B score in the renal organ system, he/she must have completed at least 6 months of therapy for the current episode of nephritis prior to Screening. Therapy must include at least 6 months of mycophenolate or at least 3 months of cyclophosphamide followed by mycophenolate or azathioprine \n\n Able and willing to give written informed consent \n\n ", - "exclusion_criteria": ": \n\n Active CNS lupus affecting mental status \n\n Active lupus nephritis requiring dialysis \n\n Laboratory exclusions: eGFR <30, WBC <2.0/mm3, hemoglobin <8 g/dL, platelet count <30,000/mm3, liver enzymes AST or ALT >4 times upper limit normal. \n\n Positive testing for HIV, hepatitis B or hepatitis C, tuberculosis (TB), or chest X-ray (CXR) findings consistent with TB or latent fungal infection. \n\n History of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix \n\n Pregnant or breast feeding \n\n A woman of childbearing potential (not post-menopausal or surgically sterile) who is not willing to use adequate contraception \n\n History of renal transplantation \n\n Herpes zoster within the past 90 days or any infection requiring hospitalization or intravenous or intramuscular antibiotics within the past 60 days \n\n Clinically significant EKG or chest X-ray changes \n\n Any other medical condition, related or unrelated to SLE, that in the opinion of the investigator would render the patient inappropriate or too unstable to complete study protocol \n\n Use of prednisone >0.5 mg/kg/day (or equivalent corticosteroid) within 1 month of Baseline visit \n\n Change or addition to immunosuppressant regimen within 3 months of Baseline visit (except corticosteroids); Use of other experimental therapeutic agents within 3 months of Baseline visit \n\n Having received belimumab within 2 months of Baseline, or having received rituximab or other B cell depleting biologic therapy within 6 months of Baseline. \n\n Comorbidities requiring corticosteroid therapy \n\n Current substance abuse or recent (within one year) history of substance abuse", - "brief_summary": "The purpose of this study is to evaluate the efficacy and safety of mesenchymal stem cells (MSCs) obtained from umbilical cords for the treatment of adults with systemic lupus erythematosus (SLE). The goal of this study is to determine if patients receiving an MSC infusion plus standard of care respond better than patients receiving placebo infusion plus standard of care.", - "NCTID": "NCT02633163" - }, - { - "brief_title": "Anti-CD20 in Systemic Lupus Erythematosus", - "phase": "Phase 1; Phase 2", - "drugs": "['Rituximab']", - "drugs_list": [ - "Rituximab" - ], - "diseases": "['Lupus Erythematosus, Systemic']", - "diseases_list": [ - "Lupus Erythematosus", - "Systemic" - ], - "enrollment": "24.0", - "inclusion_criteria": "inclusion criteria \n\n People may be eligible for this study if they: \n\n Are 18 to 70 years of age \n\n Agree to use a reliable method of birth control during treatment and for 6 months after treatment ends \n\n Have SLE (by the American College of Rheumatology criteria) \n\n Have had SLE for at least 6 months prior to screening \n\n Have active SLE disease at the screening visit \n\n Have organ disease (lung, stomach, intestinal, blood, kidney, and/or heart) \n\n Have failed standard therapy, including at least 1 immunosuppressive agent, or have experienced side effects from an immunosuppressive agent that required discontinuation of treatment \n\n Meet blood, liver, and kidney laboratory values set by the protocol \n\n Have not taken an immunosuppressive agent for 2 weeks prior to the first treatment \n\n Have been on a stable dose of oral corticosteroids, if taking them, for 4 weeks before the first week's visit. Oral corticosteroids may be altered as medically necessary after enrollment. \n\n Have at least 1 elevated autoantibody level at screening visit. \n\n ", - "exclusion_criteria": " \n\n People will not be eligible for this study if they: \n\n Are pregnant or breast-feeding \n\n Have heart, lung, nervous system, kidney, liver, stomach, intestinal, or other diseases that may place the patient at risk if participating in the trial \n\n Have cranial neuropathy (a condition affecting the head region) \n\n Are on blood-thinning agents to prevent blood clotting \n\n Have a serious skin disease \n\n Have a certain class of heart disease \n\n Have had cancer, unless surgically cured basal cell carcinoma or cervical dysplasia \n\n Have a long term serious infectious disease such as tuberculosis or a fungal infection that is now active, or active within 2 years of the baseline visit \n\n Have had HIV infection or another immunosuppressive state (chemotherapy or radiation therapy) \n\n Have received any experimental drug within 30 days of baseline visit \n\n Have received any monoclonal antibody or similar medication within 3 months of the baseline visit \n\n Received any intravenous, joint, or muscle injection of corticosteroids within 4 weeks of the baseline visit \n\n Abuse alcohol or drugs \n\n Are unwilling or unable to follow the protocol \n\n Have poor veins for receiving injections.", - "brief_summary": "The purpose of this study is to determine the safety and effectiveness of rituximab (anti-CD20) in treating systemic lupus erythematosus (SLE).~White blood cells in the body called B cells give off substances that are active in promoting SLE disease. Researchers have found that anti-CD20 can block production of these substances in another disease. This study explores whether anti-CD20 will also be safe in people with SLE and whether it may be effective in treating SLE.", - "NCTID": "NCT00036491" - }, - { - "brief_title": "Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)", - "phase": "Phase 4", - "drugs": "['Placebo plus standard therapy', 'Belimumab 10 mg/kg plus standard therapy', 'Standard therapy']", - "drugs_list": [ - "Placebo plus standard therapy", - "Belimumab 10 mg/kg plus standard therapy", - "Standard therapy" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "503.0", - "inclusion_criteria": "inclusion criteria: \n\n At least 18 years of age. \n\n Self-identified black race. \n\n Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) criteria \n\n Have active SLE disease defined as a SELENA SLEDAI score >= 8 at screening \n\n Have 2 unequivocally positive autoantibody test results defined as a positive antinuclear antibody (ANA) test [i.e., titer >= 1:80 by human epithelial cell line 2 (HEp-2) immunofluorescence assay (IFA) and/or positive enzyme immunoassay (EIA)] and/or a positive anti- double stranded deoxyribonucleic acid (dsDNA) (>= 30 international units [IU]/milliliter [mL]) serum antibody test as follows: \n\n From 2 independent time points within the study screening period. Screening results must be based on the study's central laboratory results, OR \n\n One positive historical test result and 1 positive test result during the screening period. \n\n Historical documentation of a positive ANA test (e.g., HEp-2 IFA or EIA) or anti-dsDNA (eg, anti-dsDNA by any validated commercial assay) must include the date and type of the test, the name of the testing laboratory, numerical reference range, and a key that explains values provided as positive versus negative OR negative, equivocal/borderline positive). Only unequivocally positive values as defined in the laboratory's reference range are acceptable; borderline values will not be accepted. \n\n On a stable SLE treatment regimen consisting of any of the following medications (alone or in combination) for a period of at least 30 days prior to Day 0 (i.e., day of 1st dose of study agent): \n\n Corticosteroids (prednisone or prednisone equivalent, up to 40 mg/day): For subjects on SLE combination therapy, their stable steroid dose must be fixed within the range of 0 to 40 mg/day (prednisone or prednisone equivalent). For subjects whose only SLE treatment is steroids, their stable steroid dose must be fixed within the range of 7.5 to 40 mg/day (prednisone or prednisone equivalent). For those subjects on alternating day doses of steroids, use the average of 2 daily doses to calculate the average daily steroid dose. \n\n Other immunosuppressive or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil, mycophenolate mofetil hydrochloride, and mycophenolate sodium), calcineurin inhibitors (e.g., tacrolimus, cyclosporine), sirolimus, oral cyclophosphamide, 6-mercaptopurine, mizoribine, or thalidomide. \n\n Anti-malarials (e.g., hydroxychloroquine, chloroquine, quinacrine). \n\n Non-steroidal anti-inflammatory drugs (NSAIDs). \n\n Note: \n\n Pre-existing SLE medications must be stable for at least 30 days prior to Day 0. \n\n Corticosteroids may be added as new medication or their doses adjusted only up to 30 days prior to Day 0. \n\n New SLE therapy other than corticosteroids must not be added within 60 days of Day 0. \n\n A female subject is eligible to enter the study if she is: \n\n Not pregnant or nursing; \n\n Of non-childbearing potential defined as: pre-menopausal females with a documented tubal ligation, hysterectomy, documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, or documented bilateral oophorectomy, OR postmenopausal defined as 12 months of spontaneous amenorrhea with an appropriate clinical profile [e.g., > 45 years, in the absence of hormone replacement therapy or other cause for amenorrhea]; in questionable cases obtain a blood sample for follicle stimulating hormone (FSH) and estradiol simultaneously to confirm. Diagnostic levels for FSH and estradiol vary by specific laboratories/assays; \n\n OR is of child-bearing potential with negative pregnancy test as determined by serum human chorionic gonadotrophin (hCG) test at screening and urine hCG test prior to dosing AND agrees to use one of the contraception methods for 2 weeks prior to the day of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 16 weeks following the last dose of study agent. \n\n OR has only same-sex partners, when this is her preferred and usual lifestyle. \n\n Have the ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of research-related health information), and comply with the study protocol procedures (including required study visits). \n\n ", - "exclusion_criteria": ": \n\n Have received treatment with anti-B lymphocyte stimulator (BLyS) [belimumab] at any time. \n\n Have received any of the following within 364 days of Day 0: \n\n Abatacept \n\n Other B cell targeted therapy (e.g., rituximab, other anti-cluster of differentiation [CD] 20 agents, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], BLyS-receptor fusion protein [BR3], TACI-Fc, or anti-B-cell activating factor [BAFF] (LY2127399). \n\n A biologic investigational agent other than B cell targeted therapy (e.g., abetimus sodium, anti-CD40L antibody [BG9588/IDEC-131]). \n\n Have required 3 or more courses of systemic corticosteroids for concomitant conditions (e.g., asthma, atopic dermatitis) within 364 days of Day 0. (Topical or inhaled steroids are permitted.) \n\n Have received any of the following within 90 days of Day 0: \n\n Anti-tumor necrosis factor (TNF) therapy (eg, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab). \n\n Intravenous (IV) cyclophosphamide \n\n Interleukin-1 receptor antagonist (anakinra). \n\n Intravenous immunoglobulin (IVIG). \n\n High dose prednisone or equivalent (> 100 mg/day). \n\n Plasmapheresis. \n\n Have received any of the following within 60 days of Day 0: \n\n A non-biologic investigational agent. \n\n Any new immunosuppressive/immunomodulatory agent, anti-malarial, or NSAID Note: New inhaled and topical steroids and new topical immunosuppressive agents (e.g., eye drops, topical creams) are allowed. Any NSAID use for < 1 week is allowed. \n\n Any steroid injection (e.g., intramuscular, intraarticular, or intravenous). \n\n Have received any of the following within 30 days of Day 0: \n\n A live vaccine. \n\n A change in dose of a corticosteroid, other immunosuppressive/immunomodulatory agent, anti-malarial, or NSAID \n\n Have severe lupus kidney disease (defined by proteinuria > 6 grams/24 hour or equivalent using spot urine protein to creatinine ratio, or serum creatinine > 2.5 mg/deciliter [dL]), or have severe active nephritis requiring acute therapy not permitted by protocol (e.g., IV cyclophosphamide within 90 days of Day 0), or have required hemodialysis or high-dose prednisone (> 100 mg/day) within 90 days of Day 0. \n\n Have severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident [CVA], cerebritis, or CNS vasculitis) requiring therapeutic intervention within 60 days of Day 0. \n\n Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant. \n\n Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy, or infectious diseases) which, in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk. \n\n Have a planned surgical procedure or a history of any other medical disease (e.g., cardiopulmonary), laboratory abnormality, or condition (e.g., poor venous access) that, in the opinion of the principal investigator, makes the subject unsuitable for the study. \n\n Have a history of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix. \n\n Have required management of acute or chronic infections, as follows: \n\n Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, and atypical mycobacteria). \n\n Hospitalization for treatment of infection within 60 days of Day 0. \n\n Use of parenteral (IV or intramuscular [IM]) antibiotics (antibacterials, antivirals, anti-fungals, or anti-parasitic agents) within 60 days of Day 0. \n\n Subjects who have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and/or any suicidal ideation of type 4 or 5 on the screening Columbia-Suicide Severity Rating Scale (C-SSRS) in the last 2 months or who, in the investigator's opinion, pose a significant suicide risk. \n\n Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 0. \n\n Have a historically positive test or test positive at screening for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis B core antibody, or hepatitis C antibody. \n\n Have an immunoglobulin (Ig)A deficiency (IgA level < 10 mg/dL). \n\n Have a grade 3 or greater laboratory abnormality based on the adverse event \n\n Severity grading tables except for the following that are allowed: \n\n Stable grade 3 prothrombin time (PT) secondary to anticoagulant, e.g., warfarin, treatment. \n\n Stable grade 3 partial thromboplastin time (PTT) due to lupus anticoagulant and not related to liver disease or anti-coagulant therapy. \n\n Stable grade 3/4 proteinuria (<=6 grams/24 hour equivalent by spot urine protein to creatinine ratio allowed). \n\n Stable grade 3 hypoalbuminemia due to lupus nephritis, and not related to liver disease or malnutrition. \n\n Stable grade 3 gamma glutamyl transferase (GGT) elevation due to lupus hepatitis, and not related to alcoholic liver disease, uncontrolled diabetes, or viral hepatitis. If present, any abnormalities in alanine transaminase (ALT) and/or aspartate transaminase (AST) must be <=grade 2. \n\n Stable grade 3 hemoglobin reduction due to lupus. \n\n Stable grade 3 neutropenia or stable grade 3 white blood cell count. \n\n Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies.", - "brief_summary": "The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients of black race with systemic lupus erythematosus (SLE; lupus).", - "NCTID": "NCT01632241" - }, - { - "brief_title": "Study of Methotrexate in Lupus Erythematosus", - "phase": "Phase 3", - "drugs": "['Methotrexate and folic acid']", - "drugs_list": [ - "Methotrexate and folic acid" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "86.0", - "inclusion_criteria": "inclusion criteria: \n\n men and women with diagnosis of SLE \n\n 18 years and above \n\n negative pregnancy test for female subjects of child-bearing age and must accept not to attempt to get pregnant during the period of the study \n\n Subject with active disease as defined by SLAM of at least 8 \n\n SLICC/ACR damage index of less or equal to 15 \n\n Subject must be on stable does of NSAIDs, prednisone, or antimalarial (chloroquine sulfate or hydroxychloroquine) at least 4 weeks preceding the study \n\n subjects can be under other medications as long as condition or treatment will not interfere with the experimental medications and assessments \n\n must understand either French or English and can give written informed consent \n\n ", - "exclusion_criteria": ": \n\n previous history of hypersensitivity or intolerance to methotrexate or folic acid \n\n total SLAM of less than 8 or total SLICC/ACR score of more than 15. \n\n history of medical non-compliance or inability to comply with instructions \n\n subject who have received intra-articular or intramuscular corticosteroids in the four weeks prior to study entry. \n\n clinically significant acute or chronic liver disease with the exception of autoimmune liver disease \n\n alcohol use in excess of 2 ounces of 100 proof liquor or its equivalent/week \n\n insulin requiring diabetes mellitus with morbid obesity \n\n renal impairment such that the serum creatinine is more than or equal to 175 umol/I (SI units) or 2.0 mg/dl \n\n interstitial lung disease as defined by an abnormal chest x-ray or decrease diffusion capacity (DLCO < 70% of predicted) without evidence of pulmonary hypertension. \n\n WBC count ,3,000/ cubic mm. and/or platelet count ,80,000/ cubic mm. \n\n prior use of methotrexate to treat SLE \n\n use of sulfa drugs that may potentiate the folate antagonistic effects of MTX \n\n non-steroidal anti-inflammatory drugs will be allowed throughout the trial unless there is evidence of renal failure or other contra-indications to these drugs. Their con-comitant use with MTX is routine in patients with rheumatoid arthritis. \n\n use of another cytotoxic or immunosuppressive drug such as cyclophosphamide, azathioprine, chlorambucil, cyclosporin or trimetoprime currently or in the preceding 6 months. \n\n current participation in any other drug trial or participation in such a trial in the previous one month. \n\n serologic evidence of infection with HIV \n\n biologic potential for pregnancy and not utilizing effective means of contraception \n\n recently (less than 6 months) diagnosed malignancy \n\n vitamin B12 deficiency", - "brief_summary": "The treatment of systemic lupus erythematosus (SLE) has been aimed at decreasing mortality and morbidity because the etiology of the disease is unknown. The general aim of this multicentre randomized placebo-controlled trial of low dose intermittent methotrexate with folic acid is to establish whether methotrexate shows efficacy and safety in controlling disease activity in SLE and preventing flares in disease activity or development of end-organ damage. A second aim will be to document the steroid sparing effect of methotrexate in SLE. A Third aim will be to measure toxicity and utility of methotrexate with folic acid and to perform effectiveness and utility analyses.", - "NCTID": "NCT00470522" - }, - { - "brief_title": "Pilot Study to Evaluate the Efficacy of Ruxolitinib in Alopecia Areata", - "phase": "Phase 2", - "drugs": "['Ruxolitinib']", - "drugs_list": [ - "Ruxolitinib" - ], - "diseases": "['Alopecia Areata']", - "diseases_list": [ - "Alopecia Areata" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients between 18 to 75 years of age. \n\n Patients with a diagnosis of patch type alopecia areata. \n\n Patients will have >30% and <95% total scalp hair loss at baseline as measured using the SALT score. Two patients with current episodes of alopecia totalis/universalis may be included in this study. \n\n Duration of hair loss greater than 3 months. \n\n No evidence of regrowth present at baseline. \n\n Patients may be na\u00efve to treatment or unresponsive to intralesional (IL) steroids or other treatments for alopecia areata. \n\n ", - "exclusion_criteria": ": \n\n Patients with a history of or active skin disease on the scalp such as psoriasis or seborrheic dermatitis. \n\n Patients in whom the diagnosis of alopecia areata is in question. \n\n Patients with active medical conditions or malignancies (except adequately treated basal or squamous cell carcinoma) that in the opinion of the investigator would increase the risks associated with study participation, including patients with a history of recurrent infections. \n\n Women of childbearing potential who are unable or unwilling to use two forms of birth control for the study duration. \n\n Women who are pregnant or nursing. \n\n Patients known to be HIV or hepatitis B or C positive. \n\n Patients with history or evidence of hematopoietic abnormality. \n\n Patients with <200K platelet count at baseline. \n\n Patients with history or evidence of renal or hepatic impairment. \n\n Patients with history of immunosuppression or history of recurrent serious infections. \n\n Patients unwilling or unable to discontinue treatments known to affect hair regrowth in AA. \n\n Patients taking any medication considered a strong CYP3A4 inhibitor who is unable or unwilling to stop this medication for the duration of the study. \n\n Patients receiving treatment deemed to affect alopecia areata within 2 weeks to one month of baseline visit depending on the specific treatment.", - "brief_summary": "Alopecia areata (AA) is a common disease of the immune system, known as an autoimmune disease. In the disease, the immune system mistakenly destroys the hair follicle, causing hair to fall out. Despite many people having this disease, research into its cause and into new, better ways to treat AA has lagged far behind other similar diseases of the immune system. Currently, there are no Federal Drug Administration approved drugs for AA.~Ruxolitinib (made by Incyte) is an intervention known to effectively treat a disease of the bone marrow, known as myelofibrosis. It is also being studied in the treatment of rheumatoid arthritis, another autoimmune disease, by fighting inflammation. There are some genetic and chemical similarities between those with myelofibrosis, active rheumatoid arthritis and AA, suggesting that treatment with ruxolitinib may be effective in AA. In mice specially designed for testing drugs for the treatment of human alopecia areata, this medication worked to prevent the disease AA from starting in mice that would have otherwise developed the disease. To test Ruxolitinib, we are going to treat 12 patients with moderate to severe AA for a minimum of 3 months up to 6 months. This is an open-label study, meaning that there will not be a placebo group; all patients enrolled in the study will receive the active medication. The effectiveness of the medication will be measured by changes in hair re-growth as determined by physical exam and photography, as well as by patient and physician scoring. Patients will be followed for another 3 months off of the drug to see if the effects of treatment last and if there is delayed response. The safety of the medication, ruxolitinib, in patients with alopecia areata will also be evaluated.~Blood work will be collected before medication is started, during the treatment period, and after ruxolitinib is stopped, in order to monitor for adverse effects of the medication. Small scalp biopsies and peripheral blood will be taken at the beginning of the study before treatment and also after 12 and possibly 24 weeks. Optional biopsies may also be taken at additional time points based on clinical considerations. The chemical analysis of these skin samples and blood will help us to understand how the disease happens, how the treatment works, and may even guide us to better treatments in the future.", - "NCTID": "NCT01950780" - }, - { - "brief_title": "Lupus Nephritis: Role of Environmental and Occupational Exposures", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Lupus Nephritis']", - "diseases_list": [ - "Lupus Nephritis" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Have renal biopsy proven Lupus Nephritis (with the biopsy-based diagnosis date no earlier than January 1, 1995). \n\n Reside within designated counties of eastern North Carolina and South Carolina.", - "exclusion_criteria": "", - "brief_summary": "The purpose of this study is to examine hormonal and environmental risk factors (and possible gene-environmental interactions) involved in the etiology of lupus nephritis. Our study will focus on exposures to occupational and environmental agents that have been linked to the development of systemic lupus erythematosus (SLE) or renal disease (e.g., silica dust, smoking). We will also assess potential gene environment interactions. We will examine these exposures in 100 patients with renal biopsy with documented proliferative or membraneous nephritis. We will compare exposures in the lupus nephritis patients to lupus patients who do not have nephritis and to normal controls who have participated in the Carolina Lupus Study. One hundred lupus nephritis patients (age 18 years or older, of both genders and all races) will be identified through the Glomerular Disease Collaborative Network (GDCN) Nephropathology database and participating nephrologists at the Medical University of South Carolina, Duke University Medical Center and the East Carolina Medical School.", - "NCTID": "NCT00342329" - }, - { - "brief_title": "Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)", - "phase": "Phase 2", - "drugs": "['Placebo', 'Belimumab 1 mg/kg', 'Belimumab 4 mg/kg', 'Belimumab 10 mg/kg']", - "drugs_list": [ - "Placebo", - "Belimumab 1 mg/kg", - "Belimumab 4 mg/kg", - "Belimumab 10 mg/kg" - ], - "diseases": "['Lupus Erythematosus, Systemic']", - "diseases_list": [ - "Lupus Erythematosus", - "Systemic" - ], - "enrollment": "449.0", - "inclusion_criteria": "Primary inclusion criteria \n\n Clinical diagnosis of SLE \n\n Active SLE disease \n\n On a stable SLE treatment regimen \n\n History of measurable autoantibodies \n\n Primary ", - "exclusion_criteria": " \n\n Received a non-FDA approved investigational agent within last 28 days \n\n Cyclosporin, intravenous immunoglobulin (IVIG) or plasmapheresis within last 90 days \n\n Active lupus nephritis requiring hemodialysis, cyclophosphamide (Cytoxan\u2122), or high-dose prednisone (> 100 mg/day) within last 90 days \n\n Active central nervous system (CNS) lupus requiring therapeutic intervention within last 60 days \n\n History of renal transplant \n\n History of chronic infection that has been active within last 6 months, herpes zoster within last 90 days or any infection requiring hospitalization or intravenous medication within last 60 days \n\n History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency \n\n Human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C", - "brief_summary": "The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.", - "NCTID": "NCT00071487" - }, - { - "brief_title": "Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients", - "phase": "Phase 3", - "drugs": "['Hydroxychloroquine']", - "drugs_list": [ - "Hydroxychloroquine" - ], - "diseases": "['Antiphospholipid Syndrome']", - "diseases_list": [ - "Antiphospholipid Syndrome" - ], - "enrollment": "11.0", - "inclusion_criteria": "inclusion criteria: \n\n Persistent(at least 12 weeks apart)aPL-positivity within 12 months prior to the screening defined as: \n\n aCL IgG/M (>40U,medium-to-high titer,and/or greater than the 99th percentile)and/or \n\n a\u03b22GPI IgG/M(>40U, medium-to-high titer, and/or greater than the 99th percentile)and/or \n\n Positive LA test based on the International Society of Thrombosis & Haematosis Recommendations \n\n Selected ", - "exclusion_criteria": ": \n\n History of thrombosis (arterial, venous, and/or biopsy proven microthrombosis \n\n History of Transient Ischemic Attack Confirmed by a Neurologist \n\n SLE Diagnosis based on the ACR Classification Criteria > 4/11 \n\n Other Systemic Autoimmune Diseases diagnosed based on ACR Classification Criteria \n\n Current Hydroxychloroquine or another antimalarial treatment (-3 months) \n\n Current warfarin treatment (-3 months) \n\n Current heparin therapy( -3 months) \n\n Current pregnancy \n\n History of Hydroxychloroquine eye toxicity \n\n History of Hydroxychloroquine allergy \n\n Known glucose-6-phosphate dehydrogenase deficiency", - "brief_summary": "In this multi-center international study, our aim is to determine the effectiveness of HCQ for primary thrombosis prophylaxis in persistently aPL-positive but thrombosis-free patients without systemic autoimmune diseases.", - "NCTID": "NCT01784523" - }, - { - "brief_title": "Belimumab Assessment of Safety in SLE", - "phase": "Phase 4", - "drugs": "['Placebo plus standard therapy', 'Belimumab 10 mg/kg plus standard therapy', 'Standard therapy']", - "drugs_list": [ - "Placebo plus standard therapy", - "Belimumab 10 mg/kg plus standard therapy", - "Standard therapy" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "4019.0", - "inclusion_criteria": "Key inclusion criteria: \n\n Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria. \n\n Active SLE disease. \n\n Autoantibody-positive. \n\n On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate). \n\n Key ", - "exclusion_criteria": ": \n\n Pregnant or nursing. \n\n Have received treatment with any of the following: belimumab, either as a marketed product or as an investigational agent; any B cell targeted therapy (for example, rituximab) in the past year; or any biological agent (for example, adalimumab, etanercept, infliximab, or anakinra) in the past 90 days. \n\n Have received a live vaccine within the past 30 days. \n\n Have severe active lupus kidney disease. \n\n Have severe active central nervous system (CNS) lupus. \n\n Current or past positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.", - "brief_summary": "The purpose of this study is to further enhance the existing knowledge regarding the side effects of belimumab when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE). This study mainly focuses on collecting information on serious events that are not that common or may only be seen with long-term treatment. These events include death, serious infections and other infections of interest, cancers, serious mental health problems, including depression and suicide, and serious infusion and hypersensitivity reactions. This study is being done to help understand if treatment with belimumab increases the risk for these types of events. This study will also see if patients receiving belimumab with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.", - "NCTID": "NCT01705977" - }, - { - "brief_title": "Lupus Immunosuppressive/Immunomodulatory Therapy or Stem Cell Transplant (LIST)", - "phase": "Phase 2", - "drugs": "['Leukapheresis', 'Non-myeloablative high dose immunosuppressive therapy conditioning (HDIT)', 'Autologous CD34+HPC transplantation (HSCT)', 'Plasmapheresis', 'Rabbit anti-thymocyte globulin', 'Methylprednisolone', 'Growth colony stimulating factor (G-CSF)', 'Corticosteroids', 'Mycophenolate mofetil', 'Azathioprine', 'Intravenous immunoglobulin', 'Methotrexate', 'Rituximab', 'Leflunomide']", - "drugs_list": [ - "Leukapheresis", - "Non-myeloablative high dose immunosuppressive therapy conditioning (HDIT)", - "Autologous CD34+HPC transplantation (HSCT)", - "Plasmapheresis", - "Rabbit anti-thymocyte globulin", - "Methylprednisolone", - "Growth colony stimulating factor (G-CSF)", - "Corticosteroids", - "Mycophenolate mofetil", - "Azathioprine", - "Intravenous immunoglobulin", - "Methotrexate", - "Rituximab", - "Leflunomide" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female subjects between the ages of 18 and 60 years, inclusive \n\n Meet at least 4 of 11 American College of Rheumatology (ACR) Revised Classification Criteria for SLE \n\n Have at least one of the following conditions defining severe steroid refractory disease: \n\n a) Lupus nephritis - Subjects must have severe disease, defined as meeting criteria for BILAG renal category A, and be corticosteroid dependent while receiving at least 6 months of pulse CTX at doses of 500 to 1000 mg/m2 every 4 weeks or MMF at of 2 g/day or greater. If nephritis is to constitute the sole eligibility, a renal biopsy performed within 11 months of the date of screening must show ISN/RPS 2003 classification of lupus nephritis Class III or IV disease. A renal biopsy must demonstrate the potential of a reversible (non-fibrotic) component. b) Visceral organ involvement other than nephritis - Subjects must be without mesenteric vasculitis. The subject must be BILAG cardiovascular/respiratory category A, vasculitis category A, or neurologic category A, and be corticosteroid dependent while receiving at least 3 months of oral (2 to 3 mg/kg/day or greater) or IV CTX (500 mg/m2 or greater every 4 weeks). c) Cytopenias that are immune-mediated - Subjects must be BILAG hematologic category A and be corticosteroid dependent while receiving at least one of the following: azathioprine at 2 mg/kg/day or greater for at least 3 months, MMF at 2 g/day or greater for more than 3 months, CTX at 500 mg/m2 or greater intravenously every 4 weeks or 2 mg/kg/day orally for at least 3 months, cyclosporine at 3 mg/kg/day or greater for at least 3 months, or have had a splenectomy. d) Mucocutaneous disease - Subjects must meet BILAG mucocutaneous category A and be corticosteroid dependent while receiving at least 1 of the following: azathioprine at 2 mg/kg/day or greater for at least 3 months; methotrexate at 15 mg/week or greater for at least 3 months; CTX at 500 mg/m2 or greater intravenously every 4 weeks or 2 mg/kg/day or greater orally for at least 3 months, cyclosporine at 3 mg/kg/day or greater for at least 3 months, or MMF at doses 2 g/day or greater for at least 3 months. e) Arthritis/myositis - Subjects must meet BILAG musculoskeletal category A and be corticosteroid dependent while receiving at least one of the following: azathioprine at 2 mg/kg/day or greater for at least 3 months, methotrexate at 15 mg/week or greater for at least 3 months, CTX at 500 mg/m2 or greater intravenously every 4 weeks or 2 mg/kg/day or greater orally for at least 3 months, MMF at 2 g/day or greater for at least 3 months, or cyclosporine at 3 mg/kg/day or greater for at least 3 months. \n\n Have the ability and willingness to provide written informed consent. In case of lupus cerebritis, a person designated by the subject may give consent. \n\n Must be ANA positive \n\n ", - "exclusion_criteria": ": \n\n HIV positive status \n\n Any active systemic infection \n\n Hepatitis B surface antigen positive \n\n Hepatitis C PCR positive \n\n Use of immunosuppressive agents for other indications other than SLE \n\n Any comorbid illness that in the opinion of the investigator would jeopardize the ability of the subject to tolerate therapy \n\n For lupus nephritis: renal biopsy, performed within 11 months of the screening date, showing Class I, II, or V disease or Class III or IV disease in conjunction with total sclerosis of 50% or more of the glomeruli \n\n Ongoing cancer. Patients with localized basal cell or squamous skin cancer are not excluded. \n\n Pregnancy, unwillingness to use acceptable means of birth control, or unwilling to accept or comprehend irreversible sterility as a side effect of therapy \n\n Psychiatric illness or mental deficiency not due to active lupus cerebritis making compliance with treatment or informed consent impossible \n\n Hemoglobin adjusted diffusion capacity test (DLCO) less than 30% at screening \n\n Resting left ventricular ejection fraction (LVEF) 40% or less as evaluated by echocardiogram \n\n History of an allergic reaction or hypersensitivity to Escherichia coli recombinant proteins, CTX, or any part of the investigative or control therapy \n\n SGOT/SGPT greater than 2 x the upper limit of normal, unless due to active lupus \n\n ANC 1000 or greater if not due to active SLE \n\n Subdural hematoma or any active intracranial bleeding documented within 30 days of the screening visit \n\n Failure to be approved for participation in this study by the SCSLE Protocol Eligibility Review Committee \n\n Positive tuberculin skin test \n\n Presence of mesenteric vasculitis", - "brief_summary": "Systemic lupus erythematosus, also known as lupus or SLE, is a chronic, multisystem, autoimmune disease in which the body's internal system of defense attacks its own normal tissues. This abnormal autoimmune response can result in damage to many parts of the body, especially the skin, joints, lungs, heart, brain, intestines, and kidneys. Both genetic and environmental risk factors are involved in the development of lupus, but these are poorly understood.~SLE has an overall 10-year survival between 80 and 90%. However, we estimate that severe lupus not responding to the usual available treatments has a 50% mortality rate in 10 years. Kidney problems occur in 30% to 50% of lupus patients and may progress to kidney failure. Kidney disease due to lupus occurs more frequently in African-Americans and Hispanics. Lupus can affect many parts of the body and cause damage, but the severe form can result in death from kidney disease; cardiovascular disease, specifically atherosclerosis; central nervous system disease; and infections.~Currently, no single standard therapy for treatment of severe SLE exists. Usually physicians prescribe an aggressive regimen of one or a combination of immunosuppressive/immunomodulatory treatments. This approach to therapy for all forms of severe SLE derives largely from studies of lupus nephritis. Current treatment, although effective in many people, are not effective in all patients and are associated with drug-induced morbidity. The design of the control arm for this study reflects the current status of treatment of SLE in the academic setting. Investigators may choose from a list of commonly used and currently available immunosuppressive/immunomodulatory treatments to optimize the treatment of their patients, based on their past treatment history and response to those treatments. Study treatments may consist of corticosteroids, cyclophosphamide (CTX), azathioprine, methotrexate, cyclosporine, mycophenolate mofetil (MMF), plasmapheresis, intravenous immunoglobulin (IVIG), rituximab, and leflunomide. Treatment may be changed as frequently and as necessary within the first year of the study to control the manifestations of SLE in each patient. New therapies that become available during the course of this trial may be added to the list of approved medications for this study.~In response to the absence of a uniformly effective treatment for severe lupus, autologous hematopoietic stem cell transplantation (HSCT) has been proposed as a potential therapy. Hematopoietic stem cells are immature blood cells that can develop into all of the different blood and immune cells the body uses. Researchers believe that resetting the immune system may stop or slow down the progression of the disease. The main purpose of this study is to compare two ways of treating SLE: 1) high-dose immunosuppressive therapy (HDIT) followed by HSCT and 2) currently available immunosuppressive/immunomodulatory therapies.", - "NCTID": "NCT00230035" - }, - { - "brief_title": "Prospective Study of Rapamycin for the Treatment of SLE", - "phase": "Phase 2", - "drugs": "['Rapamycin']", - "drugs_list": [ - "Rapamycin" - ], - "diseases": "['Systemic Lupus Erythematosus (SLE)']", - "diseases_list": [ - "Systemic Lupus Erythematosus (SLE)" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n For SLE Subjects: \n\n SLE patients who exhibit ongoing disease activity by SLEDAI greater or equal to 4. \n\n SLE patients whose disease activity is controlled by administration of corticosteroids, most commonly, at least 10 mg/day of prednisone. \n\n 18 years of age or older. \n\n Updated vaccinations prior to study entry. \n\n Use of effective contraception for male patients before, during and up to 12 weeks after sirolimus therapy. \n\n For Healthy Control Subjects: \n\n 18 years of age or older \n\n Must be matched with one of the SLE patients enrolled in the study by age, gender and ethnic origin \n\n Must not have any acute or chronic illness. \n\n ", - "exclusion_criteria": ": \n\n For SLE Subjects: \n\n Patients who are pregnant. \n\n Patients with allergy or intolerance to sirolimus. \n\n Patients with life-threatening manifestations of SLE. \n\n Patients with proteinuria exceeding 500 mg/24 h or urine protein/creatine ratio >0.5. \n\n Patients with total cholesterol > 300 mg/dl or triglyceride > 400 mg.dl will be excluded. \n\n Patients with acute infection requiring antibiotics. \n\n Patients on sirolimus who develop infections and require intravenous antibiotics and fail to show clinical improvement in 5 days. \n\n Patients concurrently undergoing B cell-depleting therapy, cyclophosphamide, cyclosporine, and tacrolimus. \n\n Patients who have received investigational biologic B-cell depleting products within one year of study initiation. \n\n Patients with a history of chronic viral infections (e.g., HIV, hepatitis B, hepatitis C) or with a history of a malignancy (except non-melanoma skin cancer). \n\n Due to interference with sirolimus metabolism, subjects will not be allowed to receive concomitant rifampin, ketoconazole,voriconazole, itraconazole, erythromycin, or clarithromycin during the study. \n\n Patients with any type of interstitial lung disease. \n\n For Healthy control Subjects: \n\n Subjects who are pregnant. \n\n Subjects with any acute or chronic illness.", - "brief_summary": "Systemic lupus erythematosus (SLE) is an autoimmune disease of unknown origin. It involves multiple organs including the joints, skin, kidneys and central nervous system. The disease process is caused by a dysfunction of the immune system. The drugs currently used for the treatment of SLE are only partially effective and carry significant risks for side-effects. Rapamycin, also called sirolimus or Rapamune, has been approved by the FDA to prevent rejection of organ transplants at daily doses of 2 mg to 8 mg. Patients that were resistant or intolerant to conventional medication have been effectively treated with Rapamycin and were able to decrease the amount of prednisone they needed.~The purpose of this study is to prospectively determine the therapeutic efficacy and mechanism of action of Rapamune in patients with SLE. Healthy subjects not receiving Rapamune will be asked to donate blood to serve as controls.~As part of the research effort to understand the reason for the variations in the effects of treatment drugs by different individuals, a sub-study of the DNA makeup of subjects enrolled in the trial will also be done. The purpose of the sub-study is to possibly determine whether different responses to the drugs used to treat SLE have a correlation with the differences in the genetic makeup of the subjects.", - "NCTID": "NCT00779194" - }, - { - "brief_title": "Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients", - "phase": "Phase 3", - "drugs": "['Belimumab']", - "drugs_list": [ - "Belimumab" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n Received a minimun of 6 months therapy with with belimumab 10 mg/kg in their current SLE belimumab continuation study. \n\n Be 18 years of age at the Day 0 visit. \n\n Non-prenant, non-lactating females willing to comply with specific birth control requirements as set forth in the protocol. \n\n Able to provide written informed consent to participate. \n\n Subjects who wish to enroll in the control group and the group taking a 6 month belimumab treatment holiday will need a SELENA SLEDAI score of 3 or less after the minimum of 6 months belimumab therapy, as well as having C3 and C4 complement levels at or above the lower limit of the central laboratory reference range, and are on a stable SLE treatment regimen during the 30 day screening period prior to Day 0. \n\n Subjects who wish to enroll in the long-term discontinuation group have voluntarily withdrawn from their continuation studies. \n\n ", - "exclusion_criteria": ": \n\n Subjects who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE, or experienced an adverse event (AE) in their belimumab continuation study that could, in the opinion of the principle investigator, put the subject at undue risk. \n\n Subjects who have developed any other medical diseases, laboratory abnormalities, or conditions that, in the opinion of the principle investigator, makes the subject unsuitable for the study.", - "brief_summary": "This study will assess the effect of a 24-week withdrawal followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications in subjects with stable low systemic lupus erythematosus (SLE) disease activity. Rebound phenomenon will be assessed for subjects who have permanently withdrawn from further belimumab treatment.", - "NCTID": "NCT02119156" - }, - { - "brief_title": "Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in Systemic Lupus Erythematosus (SLE) Patients With Corticosteroid Therapy and High Low-Density Lipoprotein (LDL) Cholesterol Level", - "phase": "Phase 4", - "drugs": "['Rosuvastatin', 'Simvastatin']", - "drugs_list": [ - "Rosuvastatin", - "Simvastatin" - ], - "diseases": "['Systemic Lupus Erythematosus', 'High LDL Cholesterol Level']", - "diseases_list": [ - "Systemic Lupus Erythematosus", - "High LDL Cholesterol Level" - ], - "enrollment": "140.0", - "inclusion_criteria": "inclusion criteria: \n\n SLE patients that on prednisolone more than 30 mg/day \n\n Normal liver faction: AST and ALT < 80 mg/dl \n\n Normal muscle enzyme : CPK < 100 U/L \n\n LDL cholesterol level > 100 mg/dl \n\n ", - "exclusion_criteria": ": \n\n Patients that was treated with pulse methylprednisolone or corticosteroid equivalent to prednisolone > 1mg/kg/day at screening. \n\n Statin allergy \n\n On statin treatment before screening \n\n On cyclosporine, antifugal (azole group), antibiotics (macrolide group), rifampicin, warfarin, phenytoin \n\n Pregnancy \n\n Abnormal liver function: AST or ALT > 80 mg/dl \n\n Abnormal muscle enzyme : CPK > 300 U/L", - "brief_summary": "Early statin therapy in SLE patients that have high cholesterol level and other atherosclerosis risk should reduce atherosclerosis and coronary artery events in later course of disease. By the way, statin is used in restricted groups of rheumatologists due to awareness of side effects; myositis and hepatitis, that are frequently found in SLE patients more so than other groups of atherosclerosis patients and reporting data of autoimmune diseases that occur after statin use.", - "NCTID": "NCT00866229" - }, - { - "brief_title": "Phase I Study of GSK1550188 in Japanese Subjects With Systemic Lupus Erythematosus (SLE)", - "phase": "Phase 1", - "drugs": "['GSK1550188 1mg/kg or 10mg/kg']", - "drugs_list": [ - "GSK1550188 1mg/kg or 10mg/kg" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects who gave consent to this study participation and signed into informed consent form. \n\n Subjects who are at least 20 years of age at Screening visit. \n\n Have a clinical diagnosis of Systemic Lupus Erythematosus (SLE) according to the American College of Rheumatology (ACR) classification criteria, with 4 or more of the 11 ACR criteria present, serially or simultaneously during any interval or observation. \n\n Be on either no SLE medication or a stable SLE treatment regimen of any medication (e.g., low-dose prednisone, NSAIDs; alone or in combination) for a period of at least 2 months prior to the Screening visit. \n\n Males and females. A female subject is eligible to enter the study if at least one of the following conditions apply: \n\n Not pregnant or nursing; \n\n Of non-childbearing potential (ie, women who had a hysterectomy, are postmenopausal which is defined as 1 year without menses, have both ovaries surgically removed or have current documented tubal ligation); or \n\n Of childbearing potential (ie, women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at screening, and agree to 1 of the following: \n\n Complete abstinence from penile-vaginal intercourse, when this is the female's preferred and usual lifestyle, from 2 weeks prior to administration of the 1st dose of investigational product until 8 weeks after the last dose of investigational product; or \n\n Consistent and correct use of 1 of the following acceptable methods of birth control for 1 month prior to the start of the investigational product and for 8 weeks after the last dose of investigational product: \n\n Implants of etonogestrel or levonorgestrel; \n\n Estrogenic vaginal ring \n\n Injectable progesterone \n\n Any intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year \n\n Oral contraceptives (either combined or progesterone only) \n\n Double barrier method with vaginal spermicidal agent: Condom and an occlusive cap (cervical cap/vault or diaphragm) with a vaginal spermicidal agent (foam/gel/film/cream/suppository) \n\n Percutaneous contraceptive patch \n\n The subject is positive test for anti-nuclear antibody (ANA) or anti-dsDNA antibody in serum \n\n ", - "exclusion_criteria": ": \n\n Active lupus nephritis requiring hemodialysis, intravenous cyclophosphamide (Cytoxan),or high-dose prednisone (>60 mg/day) within 6 months prior to the Screening visit \n\n The subject has severe lupus kidney disease (defined by proteinuria > 6 g/day) within 6 months prior to the Screening visit. \n\n Received IVIG or plasmapheresis within 6 months prior to Screening visit \n\n Active CNS lupus [including seizures, psychosis, organic brain syndrome, cerebrovascular accident (CVA), motor neuropathy, vasculitis] requiring medical intervention within 6 months prior to Screening visit \n\n The subject has hypogammaglobulinemia or IgA deficiency (IgA level < 10 mg/dL) \n\n History of renal transplant \n\n History or clinical evidence of active significant acute or chronic diseases (i.e., cardiovascular, pulmonary, untreated hypertension, anemia, gastrointestinal, hepatic, renal, neurological, cancer, or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk \n\n History of any other medical disease, laboratory abnormalities, or conditions which would make the subject (in the opinion of the Investigator) unsuitable for the study \n\n History of any infection requiring hospitalization or parenteral antibiotics within 4 weeks prior to Screening visit \n\n The subject has an abnormality on 12-lead ECG at screening which is clinically significant in the opinion of the investigator. \n\n The subject is currently participating in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational agent. \n\n The subject has received a biologic investigational and non-investigational agent within 12 months prior to the dosing day. \n\n The subject has received a non-biologic investigational agent within 2 months prior to the dosing day. \n\n Have evidence of current drug or alcohol abuse or dependence. \n\n Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2x upper limit of normal (ULN); alkaline phosphatase and bilirubin >1.5xULN (isolated bilirubin >1.5ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). \n\n Have a historically positive HIV test or test positive at screening for HIV. \n\n History of, or positive test at Screening visit for any of HBsAg, anti-HBcAb or anti-HCVAb. If only anti-HBcAb result is positive, HBV-DNA test will be performed. If HBV-DNA results in negative, the patient is eligible.", - "brief_summary": "The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK1550188 in Japanese subjects with Systemic Lupus Erythematosus (SLE).", - "NCTID": "NCT01381536" - }, - { - "brief_title": "Long-term Immunogenicity of a HPV Vaccine in SLE", - "phase": "", - "drugs": "['Vaccination']", - "drugs_list": [ - "Vaccination" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "84.0", - "inclusion_criteria": "inclusion criteria: \n\n SLE patients \n\n Female patients aged 18-35 years \n\n Fulfilling the American College of Rheumatology (ACR) criteria for the classification of SLE \n\n Having participated in the investigators' original HPV study in 2010 \n\n Able to give written informed consent \n\n Controls \n\n Women aged 18-35 years, matched those of SLE patients recruited \n\n No known chronic medical diseases \n\n Having participated in our HPV study in 2010", - "exclusion_criteria": "", - "brief_summary": "To study the 5-year immunogenicity against a quadrivalent HPV vaccine in patients with SLE and healthy controls.", - "NCTID": "NCT02477254" - }, - { - "brief_title": "QT Dispersion in Patients With Systemic Lupus Erythematosus (SLE)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['SLE']", - "diseases_list": [ - "SLE" - ], - "enrollment": "124.0", - "inclusion_criteria": "inclusion criteria: \n\n no administration of drugs that would potentially influence QT duration except hydroxychloroquine \n\n no history of ischemic heart disease, congestive heart failure, atrial fibrillation, bundle branch block or abnormal serum electrolytes \n\n normal resting ECG and a good-quality ECG recording to measure the QT interval. \n\n ", - "exclusion_criteria": ": \n\n moderate or severe valve disease \n\n atrial fibrillation and other ECG abnormalities \n\n systolic left ventricular dysfunction (ejection fraction <50% or left ventricular end diastolic dimension >5.5 mm \n\n unreliable identification of the end of the T wave in the ECG and \n\n known presence of cardiac disease including hypertension, diabetes or coronary artery disease.", - "brief_summary": "QT dispersion can be a useful, simple noninvasive method for the early detection of cardiac involvement in SLE patients with active disease. The investigators therefore recommend cardiovascular evaluation for every SLE patient with an SLEDAI higher than 10.", - "NCTID": "NCT01031797" - }, - { - "brief_title": "Memory and Attention Problems in Lupus: New Treatment Trial With Modafinil", - "phase": "", - "drugs": "['Modafinil']", - "drugs_list": [ - "Modafinil" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Fulfill ACR Classification Criteria for SLE \n\n >18 and < 60 years old \n\n English-speaking/reading \n\n Has a treating rheumatologist at the Hospital for Special Surgery \n\n Estimated premorbid verbal I.Q. >80 measured by the North American Adult Reading Test \n\n Functional difficulties due to cognitive dysfunction defined as positive endorsement of \u22656 items on the Cognitive Symptoms Inventory (CSI). The CSI is a 21-item, self-report questionnaire designed to assess ability to perform everyday activities in patients with rheumatic disease.47 \n\n No physical or mental disabilities that would preclude or confound the results of the neuropsychological testing, e.g., compromised use of hands, severe visual or hearing impairment \n\n Able to read normal newsprint and hear a normal speaking voice \n\n Normotensive at time of enrollment with or without medication \n\n No arrhythmia or left ventricular hypertrophy on ECG \n\n Adequate contraception (barrier method) \n\n ", - "exclusion_criteria": ": \n\n Global cognitive impairment as measured by a Modified Mini Mental Status<77 \n\n History of arrhythmia; known history of left ventricular hypertrophy, mitral valve prolapse with syndrome, or other significant cardiovascular disease with a reduced ejection fraction \n\n Renal insufficiency (creatinine clearance < 30 ml/min) including dialysis patients \n\n Known liver disease (e.g., active hepatitis) or any liver function test >2x upper limit of normal (transaminases or GGTP) \n\n Significant and serious SLE activity defined as active central nervous system disease, active nephritis, ulcerative skin disease. Other active SLE-associated conditions involving major organ systems may be excluded at the discretion of the investigator. \n\n Pregnancy, nursing mother, or unwillingness to use barrier contraception \n\n Diagnosis of active psychosis, ADHD, ADD \n\n Current use of medications contraindicated with the use of modafinil-triazolam, Phenobarbital, cyclosporine A, theophylline, carbamazepine, diazepam, phenytoin, mephenytoin, rifampin, ketoconazole, itraconazole, \n\n Illegal drug or alcohol abuse (defined as two affirmative responses to the CAGE questionnaire) \n\n Prior use of modafinil", - "brief_summary": "This study is being conducted in order to determine if the FDA-approved drug Modafinil can improve cognitive function in patients with lupus. Modafinil is currently being used to treat excessive sleepiness caused by certain sleep disorders. It has also been shown to improve attention and concentration in some people who don't have lupus or sleep disorders. This study hopes to determine if Modafinil can be used safely and effectively in lupus patients, and improve their quality of life. No medications currently exist for the treatment of lupus-associated cognitive dysfunction.", - "NCTID": "NCT00297284" - }, - { - "brief_title": "Scleroderma Treatment With Autologous Transplant (STAT) Study", - "phase": "Phase 2", - "drugs": "['Anti-Thymocyte Globulin', 'Autologous Hematopoietic Stem Cell Transplantation', 'Cyclophosphamide', 'Filgrastim', 'Laboratory Biomarker Analysis', 'Mycophenolate Mofetil', 'Peripheral Blood Stem Cell Transplantation', 'Plerixafor', 'Quality-of-Life Assessment', 'Questionnaire Administration']", - "drugs_list": [ - "Anti-Thymocyte Globulin", - "Autologous Hematopoietic Stem Cell Transplantation", - "Cyclophosphamide", - "Filgrastim", - "Laboratory Biomarker Analysis", - "Mycophenolate Mofetil", - "Peripheral Blood Stem Cell Transplantation", - "Plerixafor", - "Quality-of-Life Assessment", - "Questionnaire Administration" - ], - "diseases": "['Systemic Scleroderma']", - "diseases_list": [ - "Systemic Scleroderma" - ], - "enrollment": "21.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with SSc as defined by the American College of Rheumatology with diffuse cutaneous disease (except Group 5) at risk of disease progression \n\n Patients must have failed a prior >= 4-mponth course of either MMF/Myfortic or cyclophosphamide before being eligible for the study (determined at >= 1 week before start of mobilization); failure is defined as evidence of disease progression or absence of improvement; the response prior to MMF of cyclophosphamide will be assessed by the participating site study rheumatologist \n\n Patients must meet eligibility in at least 1 of the following 6 groups: \n\n GROUP 1: \n\n Patients must have 1) both a and b below; and 2) either c, or d \n\n a) Diffuse cutaneous scleroderma as defined by skin thickening proximal to the elbows and knees and/or involving the torso in addition to distal extremity involvement; a skin score will be obtained but not used to determine eligibility \n\n b) Duration of systemic sclerosis =< 7 years from the onset of first non-Raynaud's symptom; for those patients with disease activity between 5-7 years from the onset of first non-Raynaud's symptom, recent progression or activity of disease must be documented \n\n c) Presence of SSc-related pulmonary disease with forced vital capacity (FVC) < 80% or hemoglobin-adjusted diffusing capacity for carbon monoxide (DLCO) < 70% of predicted AND evidence of alveolitis or SSc-related interstitial lung disease by high-resolution chest computed tomography (CT) scan and/or by bronchoalveolar lavage (BAL) (interstitial lung disease may be nonspecific interstitial pneumonia [NSIP] or usual interstitial pneumonia [UIP]; a bronchoalveolar lavage [BAL] should be done to confirm the findings of alveolitis only if the high resolution CT scan [HRCT] fails to show findings typically associated with systemic sclerosis changes [ground glass NSIP, UIP, SSc related interstitial lung disease]); alveolitis by BAL cell count will be defined based on a BAL cell differential count (> 3% neutrophils and/or > 2% eosinophils) from any lavaged lobe \n\n d) History of SSc-related renal disease that may not be active at the time of screening; stable serum creatinine must be documented for a minimum of 3 months post-renal crisis at the time of the baseline visit; history of scleroderma hypertensive renal crisis is included in this criterion and is defined as follows: \n\n History of new-onset hypertension based on any of the following (measurements must be repeated and confirmed at least 2 hours apart within 3 days of first event-associated observation, with a change from baseline): \n\n Systolic blood pressure (SBP) >= 140 mmHg \n\n Diastolic blood pressure (DBP) >= 90 mmHg \n\n Rise in SBP >= 30 mmHg compared to baseline \n\n Rise in DBP >= 20 mmHg compared to baseline \n\n AND one of the following 5 laboratory criteria: \n\n Increase of >= 50 % above baseline in serum creatinine \n\n Proteinuria: >= 2+ by dipstick confirmed by protein:creatinine ratio > 2.5 \n\n Hematuria: >= 2+ by dipstick or > 10 red blood cell (RBC)s/hematopoietic-promoting factor (HPF) (without menstruation) \n\n Thrombocytopenia: < 100,000 platelets/mm^3 \n\n Hemolysis: by blood smear or increased reticulocyte count \n\n The above definition of SSc hypertensive renal crisis is independent of whether concomitant anti-hypertensive medications are used \n\n Subjects who present with solely skin and renal disease in the absence of other organ involvement, except classic SSc renal crisis as described above and including non-hypertensive renal crisis, must see a nephrologist to confirm that their renal disease is secondary to only SSc \n\n Note: Subjects may be re-screened if they fail to meet inclusion criteria on initial evaluation \n\n GROUP 2: \n\n Progressive pulmonary disease as defined by a decrease in the FVC or DLCO-adjusted by 10 or 15 percent or greater, respectively, from a prior FVC or DLCO-adjusted in the previous 18-month period \n\n Patients will have diffuse cutaneous disease and may have both FVC and DLCOcorr >= 70% at screening for the study \n\n Patients must also have evidence of alveolitis as defined by abnormal chest computed tomography (CT) or bronchoalveolar lavage (BAL) \n\n GROUP 3: Diffuse scleroderma with disease duration =< 2 years since development of first sign of skin thickening plus modified Rodnan skin score >= 25 plus either \n\n Erythrocyte sedimentation rate (ESR) > 25 mm/1st hour and/or hemoglobin (Hb) < 11 g/dL, not explained by causes other than active scleroderma \n\n Lung involvement (either FVC or DLCO < 80% and evidence of interstitial lung disease by CT scan or alveolitis by BAL) \n\n GROUP 4: Diffuse scleroderma with disease duration =< 2 years and skin score >= 30 \n\n GROUP 5: \n\n Limited cutaneous scleroderma and SSc-related pulmonary disease with FVC < 80% or hemoglobin-adjusted DLCO < 70% of predicted \n\n AND evidence of alveolitis/interstitial lung disease by high-resolution chest CT scan and/or by BAL (interstitial lung disease may be nonspecific interstitial pneumonia [NSIP] or usual interstitial pneumonia [UIP]; A bronchoalveolar lavage [BAL] should be done to confirm the findings of alveolitis only if the high resolution CT scan [HRCT] fails to show findings typically associated with systemic sclerosis changes [ground glass, NSIP, UIP, SSc related interstitial lung disease]) \n\n Alveolitis by BAL cell count will be defined based on a BAL cell differential count (> 3% neutrophils and/or > 2% eosinophils) from any lavaged lobe \n\n GROUP 6: Progressive gastrointestinal disease as defined by all of the following items: \n\n Disease duration of scleroderma =< 2 years. \n\n Documented severe malabsorption syndrome requiring nutritional support; severe malabsorption syndrome is > 10% weight loss and on total parenteral nutrition (TPN) or enteral feedings \n\n High score on distention/ bloating scale (>= 1.60 out of 3.00) on gastrointestinal (GI) questionnaire \n\n ", - "exclusion_criteria": ": \n\n Subjects with pulmonary, cardiac, hepatic, or renal impairment that would limit their ability to receive cytoreductive therapy and compromise their survival; this includes, but is not restricted to, subjects with any of the following: \n\n Pulmonary dysfunction defined as: \n\n Severe pulmonary dysfunction with (1) a hemoglobin corrected DLCO < 40% of predicted at the Baseline Screening visit, or (3) FVC < 45% of predicted Baseline Screening visit, or \n\n Partial pressure (pO2) < 70 mmHg or pCO2 >= 45 mmHg without supplemental oxygen, or \n\n O2 saturation < 92% at rest without supplemental oxygen as measured by forehead pulse oximeter \n\n Significant pulmonary artery hypertension (PAH) defined as: \n\n Peak systolic pulmonary artery pressure > 50 mmHg by resting echocardiogram will require right heart catheterization; if pulmonary artery pressure (PAP) is not evaluable on echocardiogram due to lack of a Tricuspid regurgitant jet, then normal anatomy and function as evidenced by normal right atrium and ventricle size, shape and wall thickness and septum shape must be documented to rule-out PAH; otherwise, right heart catheterization is indicated; prior history of PAH but controlled with medications will not exclude patients from the protocol; PAH is considered controlled with medications if peak systolic pulmonary artery pressure is < 45 mmHg or mean pulmonary artery pressure by right heart catheterization is < 30 mmHg at rest \n\n Mean pulmonary artery pressure by right heart catheterization exceeding 30 mmHg at rest; if mean PAP is elevated and pulmonary vascular resistance and transpulmonary gradient are normal then the patient is eligible for the protocol \n\n New York Heart Association (NYHA)/World Health Organization Class III or IV \n\n Cardiac: Uncontrolled clinically significant arrhythmias; clinical evidence of significant congestive heart failure (CHF) (NYHA Class III or IV); left ventricular ejection fraction (LVEF) < 50% by echocardiogram \n\n History/presence of arrhythmia (even controlled) on chemical anti-arrhythmic(s) must have cardiac consult to ensure the subject could safely proceed with protocol requirements \n\n Significant renal pathology defined as: \n\n Estimated creatinine clearance (CrCl) < 40 mL/min (using Cockcroft-Gault formula based on actual body weight) and serum creatinine > 2.0 mg/dL; OR \n\n Active, untreated SSc renal crisis at the time of enrollment; presence of nephrotic range proteinuria (defined as >= 3.5 gms/24 hours, or protein:creatinine ratio >= 3.5), active urinary sediment, urinary RBCs > 25 per HPF, or red cell casts require further investigation by a nephrologist to rule out glomerulonephritis, overlap syndromes, or other causes of renal disease in all subjects; subjects with glomerulonephritis or overlap syndromes will be excluded \n\n Hepatic: Active hepatitis (alanine aminotransferase [ALT], aspartate aminotransferase [AST], or bilirubin > 2 times the upper limit of normal [ULN]) or evidence of moderate to severe periportal fibrosis by liver biopsy \n\n Active or clinically significant Gastric Antral Vascular Ectasia (GAVE, watermelon stomach) \n\n Unwilling or unable to discontinue disallowed disease-modifying antirheumatic drugs (DMARDs) for treatment of SSc prior to mobilization \n\n History or presence of a 2nd autoimmune disease requiring immunosuppressive therapy that has substantial risk of immunosuppressive treatment beyond transplant with the following exceptions: \n\n History and/or presence of Sjogren's Syndrome is allowed \n\n Stable myositis (A history of myositis that is clinically stable as defined by lack of progressive proximal muscle weakness and a stable or decreasing creatine phosphokinase [CPK] < 3 x ULN) is allowed \n\n The presence of anti-double stranded (ds)-deoxyribonucleic acid (DNA) without clinical systemic lupus erythematosus in a patient with a diagnosis of otherwise pure SSc is allowed \n\n Concomitant rheumatoid arthritis without extra-articular disease characteristic of rheumatoid arthritis is allowed \n\n Active uncontrolled infection that would be a contraindication to safe use of high-dose therapy \n\n Positive study for Hepatitis B surface antigen or Hepatitis B or C confirmed by polymerase chain reaction (PCR) \n\n Positive serology for human immunodeficiency virus (HIV) \n\n Absolute neutrophil count (ANC) < 1500 cells/uL \n\n Platelets < 100,000 cells/uL \n\n Hematocrit < 27% \n\n Hemoglobin < 9.0 g/dL \n\n Malignancy within the 2 years prior to entry in study, excluding adequately treated squamous cell skin cancer, basal cell carcinoma, and carcinoma in situ; treatment must have been completed (with the exception of hormonal therapy for breast cancer) with cure/remission status verified for at least 2 years prior to entry in this study \n\n Presence of other comorbid illnesses with an estimated median life expectancy < 5 years \n\n Evidence of myelodysplasia (MDS); subjects with history of receiving any prior chemotherapy and/or radiotherapy for the treatment of malignant disease, history of greater than 2 months total prior cyclophosphamide for any condition (regardless of dose and route) and/or subjects presenting with abnormal peripheral blood counts require unilateral bone marrow aspiration for pathology, flow cytometry, cytogenetics, and fluorescence in situ hybridization (FISH) MDS panel (per institutional profile) to rule out MDS \n\n Pregnancy \n\n Inability to give voluntary informed consent \n\n Unwilling to use contraceptive methods for at least 15 months after starting treatment \n\n History of smoking tobacco (or other related/herbal products) in the prior 3 months \n\n History of prior autologous hematopoietic cell transplantation", - "brief_summary": "This phase II trial studies how well giving cyclophosphamide and anti-thymocyte globulin together followed by peripheral blood stem cell transplant (PBSCT) and mycophenolate mofetil works in treating patients with systemic scleroderma (SSc). Stem cells are collected from the patient's blood and stored prior to treatment. To store the stem cells patients are given colony-stimulating factors, such as filgrastim (G-CSF) or chemotherapy (cyclophosphamide) to help stem cells move from the bone marrow to the blood so they can be collected and stored. After storage, patients are then given high-dose chemotherapy, cyclophosphamide, and immunosuppression with anti-thymocyte globulin to suppress the immune system to prepare for the transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and immunosuppression. After the stem cells have engrafted and have matured enough to support the immune system at approximately 2-3 months, patients are given a medication called mycophenolate mofetil (MMF) or Myfortic. This medication is given to prevent worsening or reactivation of SSc and is referred to as maintenance therapy.", - "NCTID": "NCT01413100" - } - ], - "2": [ - { - "brief_title": "A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers", - "phase": "", - "drugs": "['Skin biopsy', 'Blood collection', 'Urine collection']", - "drugs_list": [ - "Skin biopsy", - "Blood collection", - "Urine collection" - ], - "diseases": "['Healthy', 'Lupus Erythematosus, Cutaneous', 'Lupus Erythematosus, Systemic', 'Lupus Erythematosus, Discoid']", - "diseases_list": [ - "Healthy", - "Lupus Erythematosus", - "Cutaneous", - "Lupus Erythematosus", - "Systemic", - "Lupus Erythematosus", - "Discoid" - ], - "enrollment": "77.0", - "inclusion_criteria": "inclusion criteria: \n\n Have Discoid Lupus Erythematosus (DLE) or Subacute Cutaneous Lupus Erythematosus (SCLE) with or without a diagnosis of Systemic Lupus Erythematosus (SLE) \n\n Active DLE or active SCLE confirmed by histological analysis (for participants with DLE or SCLE without SLE) \n\n Confirmed diagnosis of SLE using American College of Rheumatology criteria and has current or historical positive antinuclear antibodies (ANA) or anti double-stranded deoxyribonucleic acid (anti-dsDNA) (for participants with DLE or SCLE with SLE) \n\n An active skin lesion that can be biopsied (for participants with lupus erythematosus) \n\n ", - "exclusion_criteria": ": \n\n Known or thought to have a diagnosis of drug-induced lupus \n\n An active skin disease that is not a manifestation of lupus erythematosus \n\n Has an acute cutaneous lupus erythematosus rash only \n\n If taking anti-malarial therapy has not been on a stable dose for at least 8 weeks before Day 1 \n\n Participants treated with greater than 10mg/day of prednisone therapy or equivalent in the last 4 weeks prior to Day 1 \n\n Positive serology for human immunodeficiency virus antibody, hepatitis B virus, or hepatitis C virus", - "brief_summary": "The purpose of this study is to obtain skin, blood, and urine samples from patients with active cutaneous lupus lesions and from healthy participants.", - "NCTID": "NCT02034344" - }, - { - "brief_title": "Lupus Genetics Studies", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "3460.0", - "inclusion_criteria": "inclusion criteria: \n\n Families in which one or more living members have been diagnosed with systemic lupus erythematosus", - "exclusion_criteria": "", - "brief_summary": "The Lupus Genetics Studies and Lupus Family Registry & Repository are working to find the genes that reveal the causes of systemic lupus erythematosus (SLE, or lupus). The study is enrolling families of all ethnic backgrounds from the United States, Canada, Puerto Rico, and the Virgin Islands that have one or more living members diagnosed with SLE.", - "NCTID": "NCT00071175" - }, - { - "brief_title": "Role of Altered CD40-Ligand Gene Transcription in Systemic Lupus Erythematosus", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Lupus Erythematosus, Systemic']", - "diseases_list": [ - "Lupus Erythematosus", - "Systemic" - ], - "enrollment": "", - "inclusion_criteria": "Inclusion: \n\n A diagnosis of systemic lupus erythematosus", - "exclusion_criteria": "", - "brief_summary": "Systemic lupus erythematosus is an often devastating autoimmune disease which affects 1 in 2,000 women in the United States. Recently, several research laboratories have reported that a protein, named CD40-ligand (CD154), is overexpressed by a subset of white blood cells, called lymphocytes, in patients with lupus. Expression of CD154 appears critical to the generation of antibodies that cause disease in lupus. Blocking CD154 interactions in the immune system has been shown to decrease disease activity in animal models of lupus. We propose to study the regulation of CD154 in patients with lupus in hopes of inhibiting its abnormal and deleterious expression.", - "NCTID": "NCT00008749" - }, - { - "brief_title": "Cutaneous Lupus Registry", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Lupus Erythematosus']", - "diseases_list": [ - "Lupus Erythematosus" - ], - "enrollment": "500.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosed with cutaneous lupus erythematosus and/or systemic lupus erythematosus by clinical, laboratory, and histopathological findings \n\n Ability to speak and read English or Spanish at a 6th grade reading level (a translator will be available with additional consent forms in Spanish) \n\n Ability to give written informed consent \n\n ", - "exclusion_criteria": ": \n\n Less than 18 years of age, since the characteristics of the disease in these subjects could be very different \n\n Due to a medication, in which its discontinuation results in the resolution of cutaneous lupus, since the characteristics of the disease in these subjects could be very different \n\n Medical conditions who do not warrant a skin biopsy \n\n Unable to give written, informed consent or undergo a skin biopsy and/or venipuncture for any other reason", - "brief_summary": "Approximately 1.4 million individuals in the United States have systemic lupus erythematosus, and about 85% of these individuals develop skin lesions at some point of their disease. Cutaneous lupus erythematosus represents the skin manifestations of systemic lupus erythematosus, and can appear in people with or without systemic lupus. It is a mentally, physically, and emotionally debilitating disease that affects both the quality of life and social well-being of those affected.~The cause of cutaneous lupus is not completely understood, but likely includes multiple factors from our genes and the environment. Multiple genetic studies with small numbers of cutaneous lupus patients have been performed to determine which genes are associated with cutaneous lupus. This study aims to accumulate even larger numbers of patients to confidently identify genes and the proteins they encode that could contribute greatly to the formation of cutaneous lupus. The discovery of these genes and proteins would help not only uncover how cutaneous lupus forms, but also improve our abilities to diagnose this disease and predict its course, and stimulate new drug development.", - "NCTID": "NCT01266915" - }, - { - "brief_title": "CArdiovascular Risk Assessment STudy in Lupus Erythemathodes (CASTLE)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with systemic Lupus erythematosus \n\n ", - "exclusion_criteria": ": \n\n Patients without systemic Lupus erythematosus", - "brief_summary": "The key of this prospective study is to identify a potentially increased cardiovascular risk in patients with systemic Lupus erythematodes, with and without renal affection. Three groups of patients will be compared.", - "NCTID": "NCT01520155" - }, - { - "brief_title": "Vitamin D Supplementation in Systemic Lupus Erythematosus", - "phase": "", - "drugs": "['cholecalciferol']", - "drugs_list": [ - "cholecalciferol" - ], - "diseases": "['Vitamin D Deficiency']", - "diseases_list": [ - "Vitamin D Deficiency" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Systemic lupus erythematosus \n\n Age > 18 years \n\n Serum vitamin D levels [25(OH)D] < 30 ng/mL \n\n Low to moderate active disease without modification of associated treatments \n\n ", - "exclusion_criteria": ": \n\n Pregnancy \n\n Serum 25(OH)D levels > 30 ng/mL \n\n Flare requiring modification of treatments", - "brief_summary": "Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disorder. It mainly involves the skin, the joints, the nervous system and the kidney and may be life threatening.~SLE is associated with production of autoantibodies and perturbations in regulatory T cells and T helper lymphocytes producing interleukin (IL)-17 (Th17 cells).~Treatments include corticosteroids, hydroxychloroquine and immunosuppressive agents.~Immunomodulatory effects of vitamin D supplementation in VITRO was recently described, notably the expansion of Treg able to suppress inflammatory responses mediated by CD4+ and CD8+ T cells and the decrease of Th17 cells.", - "NCTID": "NCT01413230" - }, - { - "brief_title": "An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)", - "phase": "Phase 1", - "drugs": "['NNC0114-0006', 'placebo']", - "drugs_list": [ - "NNC0114-0006", - "placebo" - ], - "diseases": "['Inflammation', 'Systemic Lupus Erythematosus']", - "diseases_list": [ - "Inflammation", - "Systemic Lupus Erythematosus" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Men and women (not pregnant and not nursing) \n\n Subjects with SLE meeting the American College of Rheumatology (ACR) criteria, with a disease duration of at least 6 months \n\n Subjects with clinically active SLE defined as a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of at least 6 and positive for antinuclear antibody (ANA) and/or Anti-double-stranded DNA antibody (anti-dsDNA) \n\n If taken, background medication must be stable \n\n ", - "exclusion_criteria": ": \n\n Presence or history of active lupus nephritis (LN) within the last 4 months or active central nervous system (CNS) disease within the last 12 months \n\n Body mass index (BMI) below 18 kg/m^2 or above 38 kg/m^2", - "brief_summary": "This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate the safety and tolerability of NNC0114-0006 in subjects with systemic lupus erythematosus (SLE) concomitantly treated with stable background therapies.", - "NCTID": "NCT01689025" - }, - { - "brief_title": "A Prospective Study of Cyclophosphamide in Systemic Lupus Erythematosus Treatment", - "phase": "", - "drugs": "['Genotype Detection']", - "drugs_list": [ - "Genotype Detection" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "92.0", - "inclusion_criteria": "inclusion criteria: \n\n The American College of Rheumatology established eleven criteria in 1982,which were revised in 1997 as a classificatory instrument to operationalise the definition of SLE in clinical trials. \n\n Malar rash (rash on cheeks). \n\n Discoid rash (red, scaly patches on skin that cause scarring). \n\n Serositis: Pleurisy (inflammation of the membrane around the lungs) or pericarditis (inflammation of the membrane around the heart). \n\n Oral ulcers (includes oral or nasopharyngeal ulcers). \n\n Arthritis: nonerosive arthritis of two or more peripheral joints, with tenderness, swelling, or effusion. \n\n Photosensitivity (exposure to ultraviolet light causes rash, or other symptoms of SLE flareups). \n\n Blood-hematologic disorder-hemolytic anemia (low red blood cell count) or leukopenia (white blood cell count<4000/\u00b5l), lymphopenia (<1500/\u00b5l) or thrombocytopenia (<100000/\u00b5l) in the absence of offending drug. Hypocomplementemia is also seen, due to either consumption of C3 and C4 by immune complex-induced inflammation or to congenitally complement deficiency, which may predispose to SLE. \n\n Renal disorder: More than 0.5 g per day protein in urine or cellular casts seen in urine under a microscope. \n\n Antinuclear antibody test positive. \n\n Immunologic disorder: Positive anti-Smith, anti-ds DNA, antiphospholipid antibody, and/or false positive serological test for syphilis. Presence of anti-ss DNA in 70% of cases (though also positive with rheumatic disease and healthy persons). \n\n Neurologic disorder: Seizures or psychosis. For the purpose of identifying patients for clinical studies, a person has SLE if any 4 out of 11 symptoms are present simultaneously or serially on two separate occasions. In the meantime, the case has one of the following conditions or more; \n\n HIV (-); \n\n Signed the informed consent; \n\n Taking contraceptive measures during treatment period. \n\n ", - "exclusion_criteria": ": \n\n Poor compliance; \n\n With lupus mental damage complication, occurrence of epilepsy or unable to express subjective symptoms during the observation period. \n\n Taking drugs that affect cytochrome P450 2B6, cytochrome P450 3A4 and cytochrome P450 2C19, except corticosteroids. \n\n Abnormal liver function.", - "brief_summary": "The purpose of this study is to compare the genotype-based personal prescription of cyclophosphamide with the traditional prescription.", - "NCTID": "NCT01689350" - }, - { - "brief_title": "A Study of the Metabolic Syndrome in Patients With Systemic Lupus Erythematosus", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Metabolic Syndrome', 'Cardiovascular Risk Factors', 'Systemic Lupus Erythematosus']", - "diseases_list": [ - "Metabolic Syndrome", - "Cardiovascular Risk Factors", - "Systemic Lupus Erythematosus" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Persons aged 18 and above. \n\n Persons fulfill the diagnostic criteria of the 1997 American College of Rheumatology for systemic lupus erythematosus in the patient group. \n\n ", - "exclusion_criteria": ": \n\n Exclude a history myocardial infarction, angina or stroke.", - "brief_summary": "An increased prevalence of the metabolic syndrome has been found in patients with systemic lupus erythematosus in recent years.", - "NCTID": "NCT00982670" - }, - { - "brief_title": "Leflunomide in Systemic Lupus Erythematosus", - "phase": "Phase 2", - "drugs": "['Leflunomide']", - "drugs_list": [ - "Leflunomide" - ], - "diseases": "['Systemic Lupus Eythematosus (SLE)']", - "diseases_list": [ - "Systemic Lupus Eythematosus (SLE)" - ], - "enrollment": "27.0", - "inclusion_criteria": "inclusion criteria: \n\n Fulfill the revised ACR criteria for SLE with either evidence of active disease according to SLE Disease Activity Index (SLEDAI) \n\n ", - "exclusion_criteria": ": \n\n Patients who are pregnant or nursing women, or those with life threatening disease \n\n The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.", - "brief_summary": "A pilot study to evaluate the efficacy and safety of leflunomide in SLE patients with active disease who are refractory to cyclophosphamide", - "NCTID": "NCT00637819" - }, - { - "brief_title": "Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases", - "phase": "", - "drugs": "['anti-thymocyte globulin', 'cyclophosphamide', 'cyclosporine', 'filgrastim', 'methylprednisolone', 'prednisone', 'Autologous Peripheral Blood Stem Cell Transplantation']", - "drugs_list": [ - "anti-thymocyte globulin", - "cyclophosphamide", - "cyclosporine", - "filgrastim", - "methylprednisolone", - "prednisone", - "Autologous Peripheral Blood Stem Cell Transplantation" - ], - "diseases": "['Purpura, Schoenlein-Henoch', 'Graft Versus Host Disease', 'Anemia, Hemolytic, Autoimmune', 'Rheumatoid Arthritis', 'Churg-Strauss Syndrome', 'Hypersensitivity Vasculitis', \"Wegener's Granulomatosis\", 'Systemic Lupus Erythematosus', 'Giant Cell Arteritis', 'Pure Red Cell Aplasia', 'Juvenile Rheumatoid Arthritis', 'Polyarteritis Nodosa', 'Autoimmune Thrombocytopenic Purpura', 'Takayasu Arteritis']", - "diseases_list": [ - "Purpura", - "Schoenlein-Henoch", - "Graft Versus Host Disease", - "Anemia", - "Hemolytic", - "Autoimmune", - "Rheumatoid Arthritis", - "Churg-Strauss Syndrome", - "Hypersensitivity Vasculitis", - "Wegener's Granulomatosis", - "Systemic Lupus Erythematosus", - "Giant Cell Arteritis", - "Pure Red Cell Aplasia", - "Juvenile Rheumatoid Arthritis", - "Polyarteritis Nodosa", - "Autoimmune Thrombocytopenic Purpura", - "Takayasu Arteritis" - ], - "enrollment": "10.0", - "inclusion_criteria": "Autoimmune thrombocytopenia purpura: platelet count less than 20,000/mm3 Adequate or increased marrow megakaryocytes Presence of detectable platelet associated immunoglobulins not due to alloreactive antibodies or posttransfusion purpura Prior response to immunosuppressive therapy Platelet count chronically less than 20,000/mm3 with petechial bleeding or less than 50,000/mm3 with other bleeding OR Any history of life threatening hemorrhage Refractory to conventional therapy for at least 21 days Splenectomy At least 1 additional immunosuppressive therapy applied after splenectomy OR Controlled on conventional therapy but at price of unacceptable toxicity: Serious steroid related toxicity Absolute neutrophil count less than 500/mm3 25% of time, pure red blood cell transfusion dependent or other toxicities (e.g., hemorrhagic cystitis) that are a consequence of chronic or cytotoxic therapy Unable to wean from chronic daily or intermittent cytotoxic therapy \n\n Autoimmune hemolytic anemia or pure red cell aplasia, AIHA: Hemolytic anemia Hemoglobin less than 10.0 g/dL without transfusion Hemolysis as evidenced by both: Sustained reticulocytosis (greater than 125,000/mm3) without evidence of active bleeding or increasing hemoglobin Laboratory evidence of hemolysis Positive direct antiglobulin test or equivalent immune adherence test No evidence for paroxysmal nocturnal hemoglobinuria Negative Ham's test and sucrose hemolysis. For PRCA: Anemia due to selective decrease in marrow erythroid precursors Hemoglobin less than 10.0 g/dL without transfusion Severe reticulocytopenia (less than 20,000/mm3 despite anemia) Severely decreased marrow erythroid precursors Positive marrow coculture with serum or cells or response to immunosuppression No evidence for PNH Negative Ham's test and sucrose hemolysis Severe disease: Chronic (i.e., greater than 1 year) Transfusion dependent or untransfused hemoglobin less than 8.0 g/dL Ferritin greater than 2,000 or evidence of organ dysfunction due to iron overload Refractory to conventional therapy after all 3 of the following: High dose steroids (at least 1 mg/kg) for at least 21 days Splenectomy (except cold reactive antibodies) 1 additional immunosuppressive therapy OR Controlled on conventional therapy but at price of unacceptable toxicity \n\n Rheumatoid arthritis: Morning stiffness for at least 6 weeks Arthritis of 3 or more joint areas Arthritis of hand joints Symmetric arthritis Rheumatoid nodules Serum rheumatoid factor Radiographic changes Active rheumatoid disease as evidenced by all of the following: Elevated Westergren erythrocyte sedimentation rate Minimum of 16 swollen or tender joints using the 28 joint count method Must be at high risk for developing deforming joint disease as defined by at least 2 of the following: High titer IgM-IgG rheumatoid factor Radiographic evidence of erosive arthritis developing within the first 24 months of clinical disease Functional class II or III Refractory to conventional therapy after 12 months of: Methotrexate used in combination with cyclosporine, hydroxychloroquine, or sulfasalazine OR Intramuscular gold therapy (total dose greater than 1.0 g and duration at least 6 months) OR Controlled on conventional therapy but at price of unacceptable toxicity \n\n Juvenile rheumatoid arthritis: Under 16 years of age at onset Arthritis in 1 or more joints as defined by swelling or effusion, or presence of 2 or more of the following: Limitation of range of motion Tenderness or pain on motion Increased heat Duration of disease 6 weeks or longer Onset type defined by type of disease in first 6 months: Polyarthritis (i.e., 5 or more inflamed joints) Oligoarthritis (i.e., less than 5 inflamed joints) Systemic (i.e., arthritis with characteristic fever) Exclusion of other forms of juvenile arthritis Active disease evidenced by 1 of the following: Minimum of 2 swollen or tender joints using the 71 joint count method Endocardial or myocardial disease, or serositis Anemia or thrombocytosis of chronic disease High risk for developing deforming joint disease or evidence of potential life threatening involvement for at least 1 internal organ system Radiographic evidence of erosive arthritis developing within first 24 months of clinical disease Functional class II or III Endocardial, myocardial, pericardial, and/or pleural disease Hemoglobin less than 10.0 g/dL or platelet count greater than 600,000/mm3 Refractory to conventional therapy after 12 months of methotrexate used in combination with hydroxychloroquine, sulfasalazine, azathioprine, cyclosporine, or cyclophosphamide OR Controlled on conventional therapy but at price of unacceptable toxicity \n\n Systemic lupus erythematosus: Malar rash Discoid rash Photosensitivity Oral ulcers Arthritis Serositis Renal disorder Neurologic disorder Hematologic disorder Immunologic disorder Antinuclear antibody Must have at least 4 of 7 variables on the lupus activity scale measured Evidence of potential life threatening involvement of at least 1 internal organ system Endocardial and/or myocardial disease Central nervous system disease Pulmonary parenchymal disease Renal disease defined as WHO III, IV or V and a high activity and low chronicity index Immune mediated cytopenias Refractory to conventional therapy after attempts to control disease with at least 2 drugs, including prednisone and 1 of the following: Azathioprine Cyclophosphamide (greater than 500 mg/m2 monthly for 6 months) Cyclosporine OR Controlled on conventional therapy but at price of unacceptable toxicity \n\n Vasculitis Definitive diagnosis of 1 of the following forms: Churg-Strauss syndrome Giant cell arteritis Henoch-Schonlein purpura Hypersensitivity vasculitis Polyarteritis nodosa Takayasu arteritis Wegener's granulomatosis Evidence of active disease defined as reversible manifestations of the underlying inflammatory process Must have 1 or more of the following: Elevated Westergren erythrocyte sedimentation rate Elevated C reactive protein Decrease serum complement levels Evidence of potential life threatening involvement of at least 1 internal organ system Endocardial and/or myocardial disease Central nervous system disease Pulmonary parenchymal disease Renal disease defined as WHO III, IV or V and a high activity and low chronicity index Immune mediated cytopenias Refractory to conventional therapy (i.e., failed or relapsed within 6 months) after attempts to control disease with at least 2 drugs, including prednisone and 1 of the following: Methotrexate Azathioprine Cyclophosphamide Cyclosporine OR Controlled on conventional therapy but at price of unacceptable toxicity \n\n Performance status: ECOG 0-1 ECOG 2 allowed provided symptoms directly related to autoimmune disease Hepatic: No history of severe, prior or ongoing chronic liver disease Bilirubin less than 2.0 mg/dL AST less than 2 times upper limit of normal (ULN) Alkaline phosphatase less than 2 times ULN Renal: Creatinine less than 2.5 mg/dL OR Creatinine no greater than 2 times normal baseline for age in pediatric patients Cardiovascular: No symptoms of cardiac disease No active ischemic heart disease Ejection fraction greater than 45% by MUGA No uncontrolled hypertension Pulmonary: FEV1/FVC at least 60% OR Resting PO2 at least 80 mm Hg DLCO greater than 50% predicted O2 saturations greater than 94% in children unable to perform PFTs Neurologic: No active or ongoing ischemic or degenerative CNS disease not attributable to underlying disease Other: Not pregnant No poorly controlled diabetes HIV negative", - "exclusion_criteria": "", - "brief_summary": "OBJECTIVES: I. Determine whether there is prompt engraftment after autologous peripheral blood stem cell transplantation using filgrastim (G-CSF) mobilization in patients with life threatening autoimmune diseases.~II. Determine the kinetics of T- and B-cell immune reconstitution after a combination of timed plasmapheresis, high dose cyclophosphamide and total lymphoid irradiation, and posttransplant immunosuppression with cyclosporine in these patients.~III. Determine whether this treatment regimen beneficially influences the clinical course of these patients.", - "NCTID": "NCT00006055" - }, - { - "brief_title": "Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis", - "phase": "Phase 4", - "drugs": "['tacrolimus']", - "drugs_list": [ - "tacrolimus" - ], - "diseases": "['Lupus Nephritis', 'Lupus Erythematosus, Systemic']", - "diseases_list": [ - "Lupus Nephritis", - "Lupus Erythematosus", - "Systemic" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Fulfill the revised American College of Rheumatology criteria for SLE \n\n Have biopsy-proven membranous nephropathy secondary to SLE \n\n Nephrotic syndrome with proteinuria (> 3 g/day) and serum albumin < 30 g/dl, with or without active urinary sediments despite steroid therapy (with or without cytotoxic agents) \n\n Age over 18 with informed consent \n\n Female patients of child-bearing age and male patients who agree to maintain effective birth control practice during the study \n\n ", - "exclusion_criteria": ": \n\n Patient with abnormal liver function tests \n\n Patient with hepatitis B surface antigen or who is hepatitis C antibody positive \n\n Patient who is diabetic \n\n Patient who is receiving non-steroidal anti-inflammatory drugs (NSAIDs) or other agents known to influence urinary protein excretion \n\n Patient is allergic or intolerant to macrolide antibiotics or tacrolimus", - "brief_summary": "The investigators study the efficacy and safety of tacrolimus in the treatment of membranous nephritis secondary to systemic lupus erythematosus.", - "NCTID": "NCT00125307" - }, - { - "brief_title": "Study to Evaluate the Natural History of Osteoporosis in Children and Adolescents With Systemic Lupus Erythematosus", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Lupus Erythematosus, Systemic']", - "diseases_list": [ - "Lupus Erythematosus", - "Systemic" - ], - "enrollment": "243.0", - "inclusion_criteria": "inclusion criteria: \n\n Systemic Lupus Erythematosus subjects 4/11 of the American College of Rheumatology criteria for SLE (23), age less than 22 years. \n\n ", - "exclusion_criteria": ": \n\n Neonatal SLE or drug-induced Systemic Lupus Erythematosus \n\n Subjects who are pregnant, and subjects weighing over 300 pounds, as the densitometry techniques are not reliable above this weight. \n\n Subjects receiving calcium or vitamin D supplementation will not be excluded but this information will be recorded and evaluated further in the dietary/nutritional assessment.", - "brief_summary": "This is a study to determine if people with Lupus have weak bones.~Test which is a better method for detecting bone changes:~Dual energy X-ray absorptiometry (DXA)~Single energy quantitative computed tomography (SEQCT)~Evaluate whether weak bones are associated with things like medications or amount of fat and muscle.", - "NCTID": "NCT00582465" - }, - { - "brief_title": "Web-based Genetic Research on Lupus", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "5000.0", - "inclusion_criteria": "inclusion criteria: \n\n diagnosed with lupus by a qualified physician. \n\n consents to have 23andMe (via a partner) contact the physician to obtain medical record information \n\n willing to submit a saliva sample for DNA testing and complete online surveys related to condition \n\n at least 6 years old (minors under 18 require parental consent to enroll) \n\n access to the internet \n\n resides in the United States \n\n ", - "exclusion_criteria": ": \n\n -", - "brief_summary": "The goal of this new lupus research study is two-fold: first, to understand the genetic associations found between people's DNA and this disease, and second, to apply this understanding to drug development efforts with the investigator's partners at Pfizer.", - "NCTID": "NCT02530944" - }, - { - "brief_title": "Development and Evaluation of Modified Yoga in Systemic Lupus Erythematosus (SLE)", - "phase": "", - "drugs": "['Standard care plus Yoga']", - "drugs_list": [ - "Standard care plus Yoga" - ], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "57.0", - "inclusion_criteria": "inclusion criteria: \n\n age 18-65 \n\n Diagnosis of SLE based on ACR criteria \n\n ", - "exclusion_criteria": ": \n\n presently enrolled in a yoga program \n\n osteoporosis (T score \u2265 -2.5) \n\n avascular necrosis \n\n taking quinolone in the preceding 3 months \n\n taking \u2265 30 mg of prednisone daily \n\n history of joint replacement or organ transplant \n\n Persons with any pre-existing condition that would prevent attendance at the yoga classes", - "brief_summary": "The purpose of this study is to test the effects of a modified yoga program in persons with SLE.", - "NCTID": "NCT01176643" - }, - { - "brief_title": "A Non-drug Study Profiling Cutaneous Lupus", - "phase": "", - "drugs": "['No intervention, skin biopsy', 'No intervention, blood collection', 'No intervention, urine collection']", - "drugs_list": [ - "No intervention", - "skin biopsy", - "No intervention", - "blood collection", - "No intervention", - "urine collection" - ], - "diseases": "['Lupus Erythematosus, Cutaneous', 'Lupus Erythematosus, Systemic', 'Lupus Erythematosus, Discoid']", - "diseases_list": [ - "Lupus Erythematosus", - "Cutaneous", - "Lupus Erythematosus", - "Systemic", - "Lupus Erythematosus", - "Discoid" - ], - "enrollment": "29.0", - "inclusion_criteria": "inclusion criteria: \n\n have active DLE or active SCLE confirmed by histological analysis \n\n have a confirmed diagnosis of SLE with SLE Disease Activity Index (SLEDAI) of >6 and current or historical positive ANA or anti-dsDNA \n\n have an active skin lesion that can be biopsied \n\n if using hydroxychloroquine or chloroquine, must be on stable doses for at least 2 months prior to screening. \n\n ", - "exclusion_criteria": ": \n\n have an active skin disease other than CLE \n\n have any known malignancy within the previous 5 years (with the exception of a non-melanoma skin cancer that has been treated with no evidence of recurrence) \n\n have used a topical corticosteroid on active lesion \n\n have donated blood (volume >=500 mL) within 56 days prior to screening \n\n has been treated with drugs that are associated with CLE induction within 2 months prior to the screening \n\n have been treated with >10 mg/day prednisone therapy or equivalent in the last 4 weeks prior to screening.", - "brief_summary": "The purpose of this study is to characterize the clinical and molecular profiles of patients with cutaneous lupus.", - "NCTID": "NCT01923415" - }, - { - "brief_title": "Retrospective Analysis of the Safety and Efficacy of Hydroxychloroquine in Immune Thrombocytopenia", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Immune Thrombocytopenia', 'Systemic Lupus Erythematosus']", - "diseases_list": [ - "Immune Thrombocytopenia", - "Systemic Lupus Erythematosus" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients older than 18 years old \n\n Immune Thrombopenia according to the American Society of Hematology (ASH) guidelines 2011 \n\n Positive antinuclear antibodies > 1/160e on Hep2 cells \n\n ", - "exclusion_criteria": ": \n\n Secondary ITP (eg HIV, HCV, HBV, lymphoproliferative disorders...)", - "brief_summary": "Retrospective study of the safety and efficacy of hydroxychloroquine among patients with immune Thrombopenia (ITP).", - "NCTID": "NCT01549184" - }, - { - "brief_title": "Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus", - "phase": "Phase 4", - "drugs": "['Rosuvastatin', 'placebo', 'aspirin', 'placebo']", - "drugs_list": [ - "Rosuvastatin", - "placebo", - "aspirin", - "placebo" - ], - "diseases": "['Atherosclerosis', 'Thromboembolism', 'Systemic Lupus Erythematosus']", - "diseases_list": [ - "Atherosclerosis", - "Thromboembolism", - "Systemic Lupus Erythematosus" - ], - "enrollment": "72.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 18 years \n\n Fulfillment of at least 4 of the American College of Rheumatology (ACR) criteria for SLE \n\n Presence of any two of the following risk factors: \n\n SLE duration of >= 5 years \n\n Postmenopausal \n\n Age >= 40 years \n\n Diabetes mellitus \n\n Hypertension (140/90 mmHg) \n\n Serum low density lipoprotein (LDL) level >= 2.6 mmol/L or total cholesterol >= 5.5 mmol/L \n\n Obesity (body mass index >= 27 kg/m2) \n\n Chronic current smoker \n\n Positive antiphospholipid antibodies \n\n Renal function impairment \n\n Persistent proteinuria >= 1 gm/day for >= 6 months \n\n Informed consent obtained \n\n ", - "exclusion_criteria": ": \n\n Patients with known allergy to aspirin, or any other non-steroidal anti-inflammatory drugs (NSAIDs), or statins \n\n Patient with a history of severe gastrointestinal intolerance to aspirin (e.g., gastrointestinal bleeding) or other NSAIDs \n\n Patients with history of arterial or venous thromboembolism \n\n Patients receiving aspirin or other anti-platelet agents \n\n Patients receiving long-term non-aspirin NSAIDs \n\n Patients receiving anticoagulation therapy (e.g., warfarin) \n\n Patients with history of intolerance or allergy to the statins \n\n Pregnant or lactating women", - "brief_summary": "The purpose of this trial is to study if aspirin and statins (lipid-lowering agents) can reduce the progression of subclinical atherosclerosis in patients with systemic lupus erythematosus (SLE).", - "NCTID": "NCT00371501" - }, - { - "brief_title": "Decoy Receptor 3 (DcR3) Polymorphisms in Rheumatoid Arthritis (RA) and Systemic Lupus Erythematosus (SLE)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Rheumatoid Arthritis', 'Systemic Lupus Erythematosus']", - "diseases_list": [ - "Rheumatoid Arthritis", - "Systemic Lupus Erythematosus" - ], - "enrollment": "450.0", - "inclusion_criteria": "inclusion criteria: \n\n SLE, RA, or healthy", - "exclusion_criteria": "", - "brief_summary": "Although SLE and RA are correlated with genetic predisposing factors such as human leukocyte antigen (HLA) class II, both diseases and other genetic factors might have contributed to the development of dysregulated lymphocyte activation and autoimmunity.~Decoy receptor 3 (DcR3)/TR6 is a secreted protein belonging to the tumor necrosis factor (TNF) receptor family. It binds to Fas ligand (FasL), LIGHT, and TL1A that are all TNF family members. It was noted that soluble or solid phase DcR3-Fc co-stimulated proliferation, lymphokine production and cytotoxicity of mouse and human T cells upon T-cell receptor (TCR) ligation. Recently, the investigators found that the serum level of soluble DcR3 was higher in SLE patients than in healthy control subjects (unpublished data). Taken together, the investigators propose that in autoimmune diseases, such as RA and SLE, activated T cells secrete more DcR3 than non-autoimmune controls, which may, in turn, costimulate T cells further and cause dysregulated lymphocyte activation. With the aim to establish the possible correlation between DcR3 genetic polymorphisms, DcR3 expressions, and autoimmune phenotypes, the investigators offer this proposal. They plan to investigate the single nucleotide polymorphisms (SNPs) in the DcR3 gene. The genetic polymorphisms on the DcR3/TR6 gene and circulating DcR3 level will be compared between RA, SLE and non-autoimmune control subjects.", - "NCTID": "NCT00172666" - }, - { - "brief_title": "Role of DcR3 in T Cell Activation in SLE and RA", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['SLE', 'Rheumatoid Arthritis']", - "diseases_list": [ - "SLE", - "Rheumatoid Arthritis" - ], - "enrollment": "450.0", - "inclusion_criteria": "inclusion criteria: \n\n SLE, RA \n\n ", - "exclusion_criteria": ": \n\n nil", - "brief_summary": "Decoy receptor 3 (DcR3), a new member of tumor necrosis factor receptor (TNFR) superfamily, is a decoy receptor for FasL and could inhibit FasL-induced apoptosis, has recently been shown to induce costimulation of T cells. Systemic lupus erythematosus (SLE) is an autoimmune disease with pathogenic autoantibodies and immune complexes results from abnormal immune responses including T and B lymphocyte hyperactivity, and formation of pathogenic subsets of autoantibodies. Rhematoid arthritis (RA) is a multi-systemic autoimmune disease characterized by persistent inflammatory synovitis. Activated T lymphocytes infiltration to synovium is strongly correlated with the symptoms. DcR3 mRNA is expressed in peripheral-blood T cells and is up-regulated after antigenic stimulation. The DcR3 gene has been demonstrated to be overexpressed in patients with sclerosis or SLE; however, role of DcR3 in SLE and RA as well as the effects of DcR3 on T cell immune response is still not clear. This study is to investigate role of DcR3-induced T cell activation in SLE and RA. The genetic polymorphisms of DcR3 in association with SLE and RA will be studied to elucidate the genetic factors associated with development of SLE and RA. For further explore the possible molecular mechanisms of elevated DcR3 in association with SLE, we attempt to study whether DcR3 could induce T cell activation via costimualtion and/or inhibit the activation induced cell death (AICD) of activated T cells in SLE and RA. This study will provide a new direction of therapy in reverse T cell hyper-reactivity in SLE and RA.", - "NCTID": "NCT00275899" - }, - { - "brief_title": "Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)", - "phase": "Phase 3", - "drugs": "['Atorvastatin', 'Placebo atorvastatin']", - "drugs_list": [ - "Atorvastatin", - "Placebo atorvastatin" - ], - "diseases": "['Lupus Erythematosus, Systemic']", - "diseases_list": [ - "Lupus Erythematosus", - "Systemic" - ], - "enrollment": "221.0", - "inclusion_criteria": "inclusion criteria: \n\n Meets American College of Rheumatology (ACR) revised diagnostic guidelines for SLE \n\n Weight of 25 kg (55 lbs) or more \n\n Outpatient \n\n Ability to complete self-report questionnaires in either English or Spanish \n\n Willingness to comply with recommended diet \n\n Acceptable methods of contraception \n\n ", - "exclusion_criteria": ": \n\n Drug-induced lupus \n\n Liver disease (ALT or aspartate aminotransferase greater than 2 X normal value) \n\n Myositis (CK greater than 3 X normal value) \n\n Inability to obtain adequate-quality IMT images \n\n Current use of oral or parenteral tacrolimus or cyclosporine \n\n Dialysis or serum creatinine reater than 2.5 mg/dL \n\n Active nephrotic syndrome (urinary protein greater than 3 g/24 h and serum albumin less than 2.3 g/dl) \n\n Total cholesterol greater than 350 mg/dL \n\n Xanthoma \n\n Familial hypercholesterolemia \n\n Pregnant or breastfeeding \n\n Use of estrogen-containing contraceptives (e.g., Lo-Ovral) \n\n Unable to adhere to study regimen \n\n Life-threatening non-SLE illness that would interfere with ability to complete the study \n\n Current drug or alcohol abuse \n\n Anticipated poor compliance \n\n Participation in another drug intervention study within 30 days of study enrollment", - "brief_summary": "The purpose of this study is:~To assess the efficacy of a lipid-lowering agent (atorvastatin) on the development of atherosclerosis that predisposes children with SLE to cardiovascular events in adulthood.~To assess the safety of intermediate-term (36 months) treatment of children and young adults with atorvastatin.~To further characterize the course of SLE in children and young adults, by establishing a cohort of pediatric SLE patients to be followed prospectively.~To establish a mechanism for conducting clinical trials in rare pediatric rheumatic diseases using the Children's Arthritis and Rheumatology Research Alliance (CARRA).", - "NCTID": "NCT00065806" - }, - { - "brief_title": "Long-Term Outcome of Children and Adolescents With Anti-Phospholipid Antibodies", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Lupus']", - "diseases_list": [ - "Lupus" - ], - "enrollment": "110.0", - "inclusion_criteria": "inclusion criteria: \n\n Age: Less than 21 years at baseline exam \n\n Diagnosis: patients must meet criteria for one of five diagnostic categories based on classification according to three parameters; aPL positivity, APS criteria, and SLE criteria. \n\n The five diagnostic categories are: \n\n SLE with no aPL \n\n SLE with aPL, but without manifestations of APS \n\n SLE-like APS \n\n SLE with APS \n\n Primary APS. \n\n ", - "exclusion_criteria": ": \n\n none", - "brief_summary": "This is a study about why some people have certain types of proteins in their blood, called anti-phospholipid antibodies. The presence of these antibodies and associated complications (e.g. blood clots) are known to change over time. The purpose of this study is to evaluate these changes and improve our ability to determine the long-term outcome of affected individuals.", - "NCTID": "NCT00581763" - }, - { - "brief_title": "Efferocytosis and Genomic Polymorphism in Autoimmune Diseases", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['SLE', 'Rheumatoid Arthritis', 'Healthy Subjects']", - "diseases_list": [ - "SLE", - "Rheumatoid Arthritis", - "Healthy Subjects" - ], - "enrollment": "450.0", - "inclusion_criteria": "inclusion criteria: \n\n SLE, RA, healthy \n\n ", - "exclusion_criteria": ": \n\n nil", - "brief_summary": "Over the past few years, growing evidences revealed that clearance of apoptotic cells by phagocytosis can result in powerful anti-inflammatory and immunosuppressive effects. In vivo, apoptotic cells are cleared rapidly by neighboring cells, macrophages and related scavengers. Defective clearance of apoptotic cells has been linked closely to autoimmunity and persistent inflammatory disease. Several phagocytic receptors, bridging molecules produced by phagocytes and 'eat-me' signals on apoptotic cells are coordinately involved in mediating clearance of apoptotic cells. Complement receptors (CR3, CR4), collection, CD14, CD36 (Class B scavenger receptor), class A scavenger receptor, asialoprotein receptor, Mer receptor kinase were reported to recognize apoptotic cells. The best characterized system for clearance of apoptotic cells is the recognition of phosphatidylserine (PS) on apoptotic cells by phosphatidylserine receptor (PSR). Milk fat globule- epidermal growth factor 8 (MFG-E8) is an opsonin that bridges phagocytes (by interacting with \u03b1 v\u03b23, \u03b1v\u03b25 integrins via RGD motif) and apoptotic cells (by binding PS through Factor V/VIII-C domain). Activated macrophages produce and secret MFG-E8. MFG-E8 is a critical component in PSR-mediated phagocytosis of apoptotic cells. The dominant negative mutant MFG-E8, D89E, that carried a mutated RGD motif inhibited phagocytosis of apoptotic cells in vitro. Injection of D89E into wild type mice induced autoantibodies and IgG deposition on glomeruli. Macrophages from MFG-E8 deficiency (MFG-E8-/-) mice were impaired in engulfment of apoptotic cells, which can be restored by adding recombinant MFG-E8. The female MFG-E8-/- mice spontaneously produced high titer of autoantibodies and developed lupus-like glomerulonephritis at the age of week 40. Defective clearance of apoptotic cells is closely related to development of autoimmunity. In the past 4 years, a growing number of molecules were recognized as receptors for the PS exposed on the apoptotic cells. These molecules were capable of mediating phagocytic clearance, rendering anti-inflammatory cytokines in the phagocytes, and modulating T cell responses.~The specific aim of this proposal is to study genetic polymorphism in MFG-E8, PSR and other factors implicated in phagocytic clearance of apoptotic cells among Taiwanese. By comparing the polymorphism between patients with autoimmune disease (SLE or RA) and healthy control subjects, we will investigate if genetic variations among individuals of genes encoding proteins involved in clearance of apoptotic cells contribute to the pathogenesis of systemic autoimmune diseases SLE and RA.", - "NCTID": "NCT00364728" - }, - { - "brief_title": "Spine Quantitative Computed Tomography (QCT) for the Assessment of Osteoporosis on Children", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Systemic Lupus Erythematosus']", - "diseases_list": [ - "Systemic Lupus Erythematosus" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n For SLE subjects: Subjects age 5-21 drawn from rheumatology clinic at Children's Hospital of Philadelphia diagnosed with SLE for at least 1 month. Also subjects with no known vertebral compression fracture of L2. \n\n For Control subjects: Subjects age 5-21. Controls will be a 50% male/female. \n\n ", - "exclusion_criteria": ": \n\n For SLE subjects: Subjects with SLE will be excluded if they have conditions or drug exposure unrelated to SLE and known to impact growth or bone health. \n\n For Control subjects: Chronic disease or syndrome known to affect growth or bone health, prematurity (<37 weeks gestation), or use of any medication known to affect growth.", - "brief_summary": "The purpose of this study is to compare healthy children to children who have systemic lupus erythematosus (SLE). SLE is a childhood disease that has high risk for low bone mass and vertebral compression fractures.", - "NCTID": "NCT01330368" - } - ] - }, - { - "patient_id": "sigir-201422", - "patient": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", - "0": [ - { - "brief_title": "The Value of Pancreatic Stone Protein in Predicting Acute Appendicitis", - "phase": "", - "drugs": "['Appendicectomy']", - "drugs_list": [ - "Appendicectomy" - ], - "diseases": "['Appendicitis', 'Abdominal Pain', 'Abdominal Sepsis']", - "diseases_list": [ - "Appendicitis", - "Abdominal Pain", - "Abdominal Sepsis" - ], - "enrollment": "245.0", - "inclusion_criteria": "inclusion criteria: \n\n Age >18 years of age (subject to the current ethics approval protocol, may change) \n\n Clinical suspicion of appendicitis as the primary or differential diagnoses \n\n Patients able to provide informed consent \n\n ", - "exclusion_criteria": ": \n\n Age <18 years of age (subject to the current ethics approval protocol, may change) \n\n Abdominal discomfort without tenderness or rebound or clinical suspicion of appendicitis \n\n Pregnancy \n\n Patients with impaired consciousness \n\n Patients not able to provide informed consent \n\n Patients that will receive an appendicectomy as part of another elective procedure", - "brief_summary": "PSP (Pancreatic Stone Protein) is a compound naturally produced mainly in the pancreas and the gut. There is evidence from experimental and clinical trials that the levels of PSP in the blood rise in the presence of inflammation or infection. What is not yet well known about PSP is whether it is superior to other established blood tests (e.g. WBC or CRP) in predicting appendicitis in patients that present at the emergency room with abdominal pain and a clinical suspicion of appendicitis.", - "NCTID": "NCT01610193" - }, - { - "brief_title": "Study on Laparoscopic Operation for Perforated Appendicitis", - "phase": "", - "drugs": "['Laparoscopic appendectomy', 'Open appendectomy']", - "drugs_list": [ - "Laparoscopic appendectomy", - "Open appendectomy" - ], - "diseases": "['Perforated Appendicitis']", - "diseases_list": [ - "Perforated Appendicitis" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients admitted at the emergency station of our hospital expressing pain other than the right lower abdominal quadrant. \n\n The results of a clinical examination favored the diagnosis of perforated acute appendicitis, and the result of abdominal computed tomography revealed signs of acute appendicitis and intra-abdominal fluid accumulation. \n\n Patients were accepted to our study only if perforated appendicitis remained as the most likely diagnosis of their condition and if they were between 12 from 80 years old with informed consent. \n\n ", - "exclusion_criteria": ": \n\n Age less than 12 years \n\n older than 80 years \n\n perforated appendicitis was not revealed by pathologic investigation \n\n diverticulitis being diagnosed during surgery \n\n pelvic inflammatory disease or other gynecologic disease found during laparoscopic examination or diagnosed before operation \n\n the patient declining to enroll in this study", - "brief_summary": "The purpose of this study is to conduct a prospective observational study for the open approach and laparoscopic approach for perforated appendicitis. It is also designed to investigate if carbon dioxide pneumoperitoneum will have unwanted effect when treating perforated appendicitis with laparoscopic operation.", - "NCTID": "NCT00677989" - }, - { - "brief_title": "Perforated Appendicitis With Delayed Presentation", - "phase": "", - "drugs": "['Laparoscopic or open appendectomy', 'Expectant Management']", - "drugs_list": [ - "Laparoscopic or open appendectomy", - "Expectant Management" - ], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "5.0", - "inclusion_criteria": "inclusion criteria: \n\n All children with a delayed diagnosis of perforated appendicitis. Delayed diagnosis will be defined as symptoms for 4 or more days. Duration of symptoms will be defined as the time pain started. \n\n Confirmed diagnosis of perforated appendicitis. The diagnosis of perforated appendicitis will be based on diagnostic imaging (CT scan or ultrasound), showing an established appendiceal abscess or phlegmon. \n\n Consent to participate \n\n ", - "exclusion_criteria": ": \n\n Uncertainty about the diagnosis. \n\n The need for laparotomy for another reason. \n\n Free intraperitoneal air on imaging. \n\n Perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis. \n\n Children with other medical condition that may affect the decision to operate e.g: children with inflammatory bowel disease.", - "brief_summary": "There is no consensus among pediatric surgeons regarding the optimal treatment for children with complicated appendicitis with delayed diagnosis. With the development of broad-spectrum antibiotics, some surgeons have advocated expectant management for these children. However, there is little evidence to determine which children are most likely to benefit from this approach. Prior attempts to determine the effectiveness of expectant management for perforated appendicitis with delayed diagnosis often have not controlled for inherent differences in the clinical status of patients treated non-operatively vs. those treated with immediate appendectomy.", - "NCTID": "NCT01068288" - }, - { - "brief_title": "Improvement of Appendix Identification and Appendicitis Diagnosis in us After Administration of Oral Contrast Medium", - "phase": "", - "drugs": "['oral iodinated contrast material']", - "drugs_list": [ - "oral iodinated contrast material" - ], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n patients in emergency department with right lower quadrant pain \n\n ", - "exclusion_criteria": ": \n\n patients under 18 years old \n\n pregnant women", - "brief_summary": "Rate of appendix localization on ultrasound is not high. We suggest a way to improve it's localization by oral administration of iodinated contrast material.", - "NCTID": "NCT02194140" - }, - { - "brief_title": "Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis", - "phase": "", - "drugs": "['Appendicectomy', 'Ertapenem']", - "drugs_list": [ - "Appendicectomy", - "Ertapenem" - ], - "diseases": "['Acute Appendicitis']", - "diseases_list": [ - "Acute Appendicitis" - ], - "enrollment": "530.0", - "inclusion_criteria": "inclusion criteria: \n\n Age range from 18 to 60 years \n\n CT scan diagnosed uncomplicated acute appendicitis \n\n ", - "exclusion_criteria": ": \n\n Age under 18 years or age over 60 years \n\n Pregnancy or breast-feeding \n\n Allergy to contrast media or iodine \n\n Renal insufficiency \n\n metformin medication (DM) \n\n Peritonitis (a perforated appendix) \n\n Lack of co-operation (unable to give consent) \n\n A severe other medical condition \n\n CT-scan: other diagnosis, fecal lithiasis in appendix, perforation, abscess, suspicion of a tumour", - "brief_summary": "Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a routine operation. At the same time other similar intra-abdominal infections, such as diverticulitis, are treated with antibiotics. There have been some encouraging reports on successful treatment of appendicitis with antibiotics and it has been estimated that operative treatment might be necessary for only 15 - 20 % of patients with acute appendicitis.~The aim of this randomized prospective study is to compare operative treatment (open appendicectomy) with conservative treatment with antibiotics (ertapenem, Invanz). Before randomization acute uncomplicated appendicitis is diagnosed with a CT scan.The hypothesis of the study is that the majority of patients with uncomplicated acute appendicitis can be treated successfully with antibiotics and unnecessary appendicectomies can be avoided.", - "NCTID": "NCT01022567" - }, - { - "brief_title": "Ultrasound-guided Abdominal Wall Nerve Blockade in Laparoscopic Surgery for Acute Appendicitis.", - "phase": "", - "drugs": "['Ropivacaine', 'Saline 9%']", - "drugs_list": [ - "Ropivacaine", - "Saline 9%" - ], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "56.0", - "inclusion_criteria": "inclusion criteria: \n\n Age above 18 years \n\n Patients undergoing diagnostic laparoscopy for acute appendicitis \n\n American Society of Anaesthesiology group 1-3 \n\n General Anaesthesia \n\n ", - "exclusion_criteria": ": \n\n Inability to cooperate \n\n Inability to understand and talk danish \n\n Allergic to ropivacaine \n\n Drug and alcohol abuse \n\n Pregnancy or nursing", - "brief_summary": "Acute appendicitis is a common disease and usually occurs within the ages of 10-30 years old. Ten percent of the population will get this disease during a lifetime. At Bispebjerg hospital it is one of the most common acute surgeries performed. Though at Bispebjerg hospital the surgery is only performed on adults as there is no pediatric ward. The surgical technique is primarily laparoscopic surgery, where the patients have their appendix removed while in general anaesthesia. During the last three years Bispebjerg hospital has had an average of 287 patients per year undergoing laparoscopic surgery. From January to the September 2012 a total of 211 patients have had the operation, with 29% having the operation performed during daytime, 48% in the evening and 22% at night. Open appendectomy is only performed in cases where laparoscopic surgery is impossible, this is often due to adhesions, scar tissue from former abdominal surgery or peritonitis. The scars from laparoscopic surgery are usually smaller than that from an open appendectomy, but it gives the patient three smaller scars divided on three abdominal quadrants instead of one larger scar on one quadrant.~The investigators want to conduct a clinical trial with fifty six patients undergoing laparoscopic surgery due to acute appendicitis. The investigators want to find out if it is possible to improve the post-operative pain management within this very large group of patients undergoing acute surgery. In detail, the investigators wish to explore whether the use of the BD-TAP blockade in the abdominal wall on patients undergoing laparoscopic surgery due to acute appendicitis, can anesthetize the patients completely or partially, so they can avoid morphine intake completely or partially during the post-operative phase (12-24 hours). The research project will be a randomized, double-blinded, controlled clinical trial.", - "NCTID": "NCT01825863" - }, - { - "brief_title": "Wound Healing After Emergency Appendicectomy", - "phase": "Phase 4", - "drugs": "['appendicectomy']", - "drugs_list": [ - "appendicectomy" - ], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult patient with acute appendicitis \n\n ", - "exclusion_criteria": ": \n\n Children", - "brief_summary": "The purpose of this trial is to compare two techniques of wound closure in open appendicectomies in adult patients: continuous, absorbable, intradermal suture and interrupted, non-absorbable sutures.", - "NCTID": "NCT00913445" - }, - { - "brief_title": "Safety and Efficacy of Single Daily Dose of Ceftriaxone and Metronidazole for Treatment of Complicated Appendicitis in Children", - "phase": "Phase 4", - "drugs": "['ceftriaxone, metronidazole/ampicillin, gentamicin, and metronidazole']", - "drugs_list": [ - "ceftriaxone", - "metronidazole/ampicillin", - "gentamicin", - "and metronidazole" - ], - "diseases": "['Complicated Appendicitis']", - "diseases_list": [ - "Complicated Appendicitis" - ], - "enrollment": "43.0", - "inclusion_criteria": "inclusion criteria: \n\n Children age 1-14 years CA that was defined by one of the followings: \n\n Demonstration by abdominal ultrasound (US) and/or computed tomography (CT) of appendix perforation and/or peri-appendicular abscess \n\n Demonstration by abdominal ultrasound (US) of free fluid, and signs of diffuse peritoneal irritation in the right lower quadrant of the abdomen 3 \n\n ", - "exclusion_criteria": ": \n\n Documented allergy to any of the study medications, acute or renal insufficiency at admission, and severe septic shock at admission.", - "brief_summary": "A prospective open randomized study conducted between July 1st 2008 and June 30th, 2009. Included were children younger than 14 years with Complicated appendicitis randomly assigned either to a single daily dose of Ceftriaxone and Metronidazole or Ampicillin, Gentamicin, and Metronidazole. The outcome variables compared were: maximum daily temperatures, overall duration of fever, time return to oral intake, length of antibiotic therapy, results of repeat WBC measure, general/intra abdominal complications, need for intra abdominal abscess drainage, Length of stay and adverse reaction.", - "NCTID": "NCT01678365" - }, - { - "brief_title": "Warm Humid Gas Insufflation for Appendix Removal by Minimally Invasive Surgery Warm Humid Insufflation for Appendix Removal by Minimally Invasive Surgery Trial (WARMIST)", - "phase": "", - "drugs": "['Fisher and Paykel Insuflow (MR 860) Surgical Humidification Device', 'Laparoscopic Appendicectomy', 'Laparoscopic Appendicectomy']", - "drugs_list": [ - "Fisher and Paykel Insuflow (MR 860) Surgical Humidification Device", - "Laparoscopic Appendicectomy", - "Laparoscopic Appendicectomy" - ], - "diseases": "['Peritoneal Dessication Damage and Inflammation', 'Peri-operative Hypothermia']", - "diseases_list": [ - "Peritoneal Dessication Damage and Inflammation", - "Peri-operative Hypothermia" - ], - "enrollment": "190.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy volunteers aged 8-14 years presenting to Starship Children's Hospital (Auckland, New Zealand) within the study period diagnosed clinically with acute appendicitis requiring diagnostic laparoscopy +/- appendicectomy. \n\n ", - "exclusion_criteria": ": \n\n Consent to participate in study not obtained, partial or total blindness, unable to speak and read sufficient English, presence of any abdominal prostheses, diagnosis of mental retardation, developmental delay, neuromuscular impairment, attention-deficit disorder, chronic pain, or psychiatric illness, immunosuppression, allergy to morphine, and history of previous abdominal surgery", - "brief_summary": "In laparoscopic (key-hole) surgery, the use of cold dry carbon dioxide gas to inflate the abdominal cavity for the creation a clear operating field, results in damage to the cavity lining, known as the peritoneum. This has been associated with negative effects on post-operative recovery. Adult studies using warm humidified insufflation gas have indicated possible decreased post-operative pain, reduced narcotic analgesia requirements, decreased fogging of the laparoscopic camera lens, and reduced time to return to normal activities. Cold dry gas during laparoscopic surgery also has potential to cause abnormal decrease in body core temperature (hypothermia). This has been established by trials in adult humans and animal models. The WARMIST study aims to investigate for whether warm humid gas insuflation during laparoscopic removal of the appendix in children reduces intraoperative temperature variations, post-operative pain (indicated by morphine usage and pain scores), length of hospital stay and degree of camera lens fogging, and speed post-operative recovery compared to using cold dry gas insufflation.", - "NCTID": "NCT01027455" - }, - { - "brief_title": "Transumbilical Single Incision Versus Conventional Three Incisions Laparoscopic Appendicectomy", - "phase": "", - "drugs": "['transumbilical single incision laparoscopic appendicectomy', 'conventional laparoscopic appendicectomy']", - "drugs_list": [ - "transumbilical single incision laparoscopic appendicectomy", - "conventional laparoscopic appendicectomy" - ], - "diseases": "['Acute Appendicitis']", - "diseases_list": [ - "Acute Appendicitis" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients will be at least 18 years of age. \n\n Male or female (excluding pregnant females). \n\n Patients with ASA \u2266 3. \n\n Patients informed about the study, and will have read; understood and signed the patient informed consent. Patients will be willing and able to submit to postoperative follow-up evaluations. \n\n ", - "exclusion_criteria": ": \n\n Patients have previous history of abdominal surgery. \n\n Patients with ASA > 3. \n\n Patients with any conditions that were not suspected preoperatively and are only discovered at the time of the operation. \n\n Patients who are incompetent in giving consent.", - "brief_summary": "Laparoscopic appendicectomy is widely practiced in Hong Kong nowadays with shorter hospital stay and less wound complications. Most of the time, three small wounds of less than 10mm will be adequate enough for the completion of the surgery with minimal pain.~Recently, the concept of Natural Orifice Transluminal Endoscopic Surgery (N.O.T.E.S) led to the attention of single incision laparoscopic surgery (SILS) again in the surgical community. SILS is not a new idea. The first SILS for cholecystectomy was reported in 1997 by Navarra et al. However, the close proximity of the instruments, limitation in triangulation during dissection and suboptimal exposure of the surgical field has made this approach unpopular in last decade. Because the concept of N.O.T.E.S and the newly designed access port, surgeons are now focused again on SILS. The Chinese University of Hong Kong has recently release their preliminary results on the use of SILS on appendicectomy with satisfactory results in terms of less post-operative pain and less prominent scar. However, it was a case series with limited number of patients. In order to test the advantages of SILS on the management of patients with acute appendicitis, a double blinded randomized clinical trial is conducted.", - "NCTID": "NCT01024439" - }, - { - "brief_title": "The Laparoscopic Appendicitis Score; a Multicenter Validation Study", - "phase": "", - "drugs": "['LAPP score']", - "drugs_list": [ - "LAPP score" - ], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "342.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients operated for the clinical suspicion of acute appendicitis that will undergo a diagnostic laparoscopy. \n\n Age \u2265 18 years. \n\n Written informed consent \n\n ", - "exclusion_criteria": ": \n\n Diagnostic laparoscopy and planned appendectomy for an appendectomy a froid. \n\n Primarily chosen for an open appendectomy. \n\n Not able to give informed consent (for example language barrier or legally incapable). \n\n Refused informed consent.", - "brief_summary": "SUMMARY~Rationale: A diagnostic laparoscopy is a frequently used method to confirm the diagnosis appendicitis. However until recently evidence-based laparoscopic criteria for determining appendicitis were not defined. If there is any doubt about the presence of appendicitis the appendix is usually removed. In a single centre prospective pilot study on 134 patients the investigators were able to define the Laparoscopic APPendicitis (LAPP) score. In the current study the investigators will validate the LAPP score in order to decrease the negative appendectomy rate by 50%. Eventually the score should lead to a decrease in morbidity.~Objective: To decrease the negative appendectomy rate by 50%.~Study design: A multicenter prospective validation study~Study population: All patients, \u226518 years, operated with a diagnostic laparoscopy for the clinical suspicion appendicitis. Sample size calculation, performed by a statistician/ epidemiologist of the Trial Coordination Centre, showed the need to analyse 778 patients.~Intervention (if applicable): Patients operated on appendicitis in 2008 and 2009 (n=843), were retrospectively analysed for negative appendectomies. This cohort will serve as the control group. In this control group no intervention was given, as the LAPP score was not yet defined.~In the 778 prospective analysed patients, the LAPP score will be used during a diagnostic laparoscopy. With the LAPP score the investigators intend to halve the number of negative appendectomies.~Main study parameters/endpoints: A decrease in the negative appendectomy rate from 9% to 5%. This decrease should not lead to an increase in missed appendicitis (occurring within 30 days), defined as requiring a surgical re-intervention or as an appendicitis or appendicular infiltrate on an ultrasound or CT-scan.~Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risk of implementation of the LAPP score is minimal. In theory, the use of the LAPP score might lead to an increase risk in missed appendicitis. This might lead to an increase in morbidity.", - "NCTID": "NCT02029781" - }, - { - "brief_title": "A Comparison of Appendicectomy Outcomes in Children Between Paediatric and General Surgical Centres in Scotland", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "4000.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients aged 2 - 12 years old who within the 10 year period of January 2001 - December 2010 are entered on the SMR01 database as having a code for appendicectomy. \n\n Episodes will be extracted with the following codes: \n\n OPCS (Office of Population Censuses and Surveys), revision 4.5 \n\n H01 Emergency excision of appendix \n\n ", - "exclusion_criteria": ": \n\n We will exclude patients for whom incidental appendicectomy has occurred at the same time as another major abdominal surgical procedure. \n\n We will exclude patients who are non-resident in Scotland since we will be unable to derive depravity index and urban-rural classification, and may not have access to information on co-morbidities and mortality.", - "brief_summary": "Introduction~Appendicectomy (or appendectomy in US usage) is the single most commonly performed emergency surgical operation performed on British children. Previous investigation of outcomes following appendicectomy has suggested that specialist surgeons and high volume centres have fewer negative appendicectomies (i.e. the appendix found to be non-diseased), although there has not been consistent association found between hospital type or surgeon experience and complication rate or admission rate.~Scotland has 3 dedicated children's surgery centres but straightforward children's surgery such as appendicectomy is also carried out in the country's general surgical centres. Appendicectomy outcome variations have not been explored in the Scottish National Health Service (NHS).~Aim~This study will compare appendicectomy outcomes in children between Scotland's specialist paediatric centres and general surgical centres.~Methods~This is a retrospective study of all appendicectomies performed in Scotland during the period from 1st January 2001 - 31st December 2010, on children aged 2 - 12 years old. It will use routinely collected administrative data from the Information Services Division of NHS National Services Scotland.~The study will compare risk-adjusted 30 day/in-patient mortality, 30 day re-admission rate, 30 day re-operation rate, post-operative length of stay and negative appendicectomy rates.", - "NCTID": "NCT02047786" - }, - { - "brief_title": "Lavage and Suction of the Right Upper Quadrant to Reduce Post Laparoscopic Shoulder Pain", - "phase": "", - "drugs": "['Active lavage and suction']", - "drugs_list": [ - "Active lavage and suction" - ], - "diseases": "['Shoulder Pain']", - "diseases_list": [ - "Shoulder Pain" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n English speaking patient \n\n Female \n\n Age 18-75 \n\n must undergo laparoscopic surgery \n\n willing to participate in the study \n\n ", - "exclusion_criteria": ": \n\n Male patients \n\n Under 18 or older than 75 \n\n Laparoscopic procedures that get converted to laparotomy \n\n Intraoperative hemorrhage more than 500 cc \n\n Patients with active joint disease \n\n History of shoulder surgery \n\n Intraoperative laceration to the liver \n\n Malignancy \n\n Long term daily narcotic use \n\n Chronic right upper quadrant/ shoulder pain \n\n Pregnancy \n\n History of dementia, Alzheimers, stroke or other condition causing altered mental status", - "brief_summary": "The use of laparoscopy in gynecologic surgery has been well established to decrease morbidity, blood loss, hospital stay, and post-operative pain when compared to traditional open abdominal surgery. However, the laparoscopic technique is associated with post-operative shoulder pain.~We hypothesize that a combination of intraperitoneal saline lavage and active suction removal of carbon dioxide gas from the right upper quadrant of the abdomen will decrease incidence of post-laparoscopic shoulder pain when compared to passive exsufflation of carbon dioxide gas.", - "NCTID": "NCT02004470" - }, - { - "brief_title": "Accuracy of Surgeon-performed Ultrasound in Detecting Gallstones - a Validation Study", - "phase": "", - "drugs": "['ultrasound']", - "drugs_list": [ - "ultrasound" - ], - "diseases": "['Gallstones']", - "diseases_list": [ - "Gallstones" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients referred to the radiology department for an abdominal ultrasound \n\n Age > 18 years \n\n ", - "exclusion_criteria": ": \n\n Inability to communicate with the examiner \n\n Referral for intervention \n\n Metastasis screening \n\n Referrals concerning contrast enhanced examinations", - "brief_summary": "Aims: To prospectively investigate the accuracy of surgeon-performed ultrasound for the detection of gallstones.~Methods: 179 adult patients, with an acute or elective referral for an abdominal ultrasound examination, were examined with a right upper quadrant ultrasound scan by a radiologist as well as surgeon. The surgeons had undergone a four-week long education in ultrasound before participating in the study. Ultrasound findings of the surgeon were compared to those of the radiologist, using radiologist-performed ultrasound as reference standard.", - "NCTID": "NCT02469935" - }, - { - "brief_title": "Ability of Bedside Ultrasound to Predict Progression of Severity of Disease in Dengue Fever", - "phase": "", - "drugs": "['diagnostic bedside ultrasound']", - "drugs_list": [ - "diagnostic bedside ultrasound" - ], - "diseases": "['Dengue', 'Disease Progression']", - "diseases_list": [ - "Dengue", - "Disease Progression" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Age >3 months and <16 years \n\n Clinical suspicion of dengue hemorrhagic fever. (Revised WHO Classification System) \n\n Not a prisoner or ward of the state \n\n Parents able and willing to give consent. Children older then 7 able and willing to give assent \n\n ", - "exclusion_criteria": ": \n\n Allergic to Ultrasound gel \n\n Prisoners or wards of the state \n\n Unstable patients \n\n Known pleural effusion, ascites, or gallbladder wall thickening.", - "brief_summary": "The purpose of this study is determine the ability of bedide ultrasound performed in the Emergency Department and Outpatient Department can predict the severity of disease during a Dengue Fever outbreak in children, in Siem Reap, Cambodia. Our hypothesis is that the presence of gallbladder wall thickening and/or pleural effusions in children correlates with progression to Dengue hemorrhagic fever and Dengue shock. In addition, we hypothesize that sonographic imaging of pediatric patients presenting to the emergency department with a fever during a Dengue fever outbreak will change management and disposition.", - "NCTID": "NCT02134652" - }, - { - "brief_title": "A Trial of Single Incision Versus Four Ports Laparoscopic Cholecystectomy", - "phase": "", - "drugs": "['Single Incision Laparoscopic Cholecystectomy (SILC)', 'Four Ports Laparoscopic Cholecystectomy (4PLC)']", - "drugs_list": [ - "Single Incision Laparoscopic Cholecystectomy (SILC)", - "Four Ports Laparoscopic Cholecystectomy (4PLC)" - ], - "diseases": "['Cholelithiasis']", - "diseases_list": [ - "Cholelithiasis" - ], - "enrollment": "73.0", - "inclusion_criteria": "inclusion criteria: \n\n age higher than 18 and lower than 80 \n\n American Society of Anesthesiologists class (ASA) I-II, \n\n absence of any previous anesthetic complication, \n\n accompaniment by a responsible adult during 24 hours, \n\n symptomatic gallstones candidate to cholecystectomy \n\n and a signed informed consent. \n\n ", - "exclusion_criteria": ": \n\n a Body Mass Index (BMI) higher than 35, \n\n any laparoscopic contraindication, \n\n acute cholecystitis background, suspect of Mirizzi's Syndrome, common duct stones or malignancy, \n\n anti-inflammatory allergy \n\n psychiatric history that could hinder ambulatory procedure", - "brief_summary": "Background: Single-incision laparoscopic cholecystectomy (SILC) is increasingly being used as a minimally invasive surgery with potential benefits over 4-port laparoscopic cholecystectomy (LC) in terms of postoperative pain and faster recovery.~Methods: Seventy-three patients with symptomatic cholelithiasis were randomized to SILC (n=37) or LC (n=36). Data measures included operative details, adverse events, postoperative pain and analgesic requirements, success of the ambulatory process, return to normal activity and return to work, cosmetic results and quality of life score.", - "NCTID": "NCT02375529" - }, - { - "brief_title": "Study of the Preservation of the Left Colic Artery on Rectum Cancer Surgery", - "phase": "", - "drugs": "['preserving the left colic artery', 'not preserving the left colic artery']", - "drugs_list": [ - "preserving the left colic artery", - "not preserving the left colic artery" - ], - "diseases": "['Rectum Cancer']", - "diseases_list": [ - "Rectum Cancer" - ], - "enrollment": "57.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients coming to FirstJilinU diagnosed rectum cancer by endoscopy and pathology. \n\n The rectum cancer is the first malignant neoplasm the patient has got. \n\n The cancer is solitary, and is 3cm to 20cm to the anus. \n\n The surgical method is limited to Dixon. \n\n ", - "exclusion_criteria": ": \n\n Being in the acute phase of inflammation before operation and emergency surgery. \n\n Patients receiving steroid medication or preoperative radiotherapy\u3002 \n\n Discovering macrometastasis before or in the operation. \n\n The rectum cancer that can't be radical resected.", - "brief_summary": "To evaluate the influence to the blood supply of the anastomosis and the harvest of the No. 253 lymph nodes in different surgical methods--- preserving the left colic artery (LCA) and resect the No. 253 lymph node specifically in the radical resection of rectal carcinoma or dividing at the root of the inferior mesenteric artery (IMA) in the radical resection of rectal carcinoma.", - "NCTID": "NCT01979029" - }, - { - "brief_title": "Concurrent Hyperthermia and Chemoradiotherapy in LAPC: Phase II Study", - "phase": "Phase 2", - "drugs": "['Chemoradiotherapy (CTRT)', 'Thermochemoradiotherapy (CTRTHT)']", - "drugs_list": [ - "Chemoradiotherapy (CTRT)", - "Thermochemoradiotherapy (CTRTHT)" - ], - "diseases": "['Cancer Pancreas']", - "diseases_list": [ - "Cancer Pancreas" - ], - "enrollment": "78.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients of locally advanced pancreatic cancer with \n\n Major venous infiltration / thrombosis of the portal vein or superior mesenteric vein extending for several centimeters \n\n Tumor encasement (\u2265180\u00b0) of the superior mesentric artery or proximal hepatic artery \n\n Tumor abutment (<180\u00b0) of the celiac trunk \n\n Tumor invasion of the aorta \n\n Presence of metastasis to lymph nodes beyond the field of resection \n\n Histopathologically proven ductal adenocarcinoma of the pancreas (biopsy /cytology) \n\n Eastern Cooperative Oncology Group (ECOG) performance scale 0 and 1 \n\n Age: 18 to 80 years \n\n At least one of the diameters of the primary tumor or regional lymph node or both should be greater than 4 cm, as confirmed on contrast-enhanced computed tomography (CECT). \n\n Patients, have primary tumor or regional lymph node or both lesser than 4 cm, as confirmed on CECT but have specific medical contraindications to stereotactic body radiation therapy or irreversible electroporation or as per patient's preference could be considered for HEATPAC. \n\n No evidence of any distant metastasis \n\n Patients with microscopic peritoneal carcinomatosis, detected on laparoscopy following 4 cycles on neo-adjuvant FOLFIRINOX would be included. \n\n Estimated life expectancy of at least 6 months \n\n Adequate kidney functionality defined as creatinine clearance >50ml/min \n\n Adequate liver functionality defined as total bilirubin \u2264 2x of the upper limit of normal \n\n Adequate bone marrow reserves: White blood cell count \u2265 2.5 x 10\u02c49/L, Platelet count \u2265 100 x 10\u02c49/L, Hemoglobin \u2265 8.0g/L \n\n Women of child-bearing age must secure sufficient contraception control during the clinical trial and six months after the clinical trial is completed \n\n For females of child bearing potential, negative pregnancy test within 2 week prior to randomization. \n\n Female patients should not be lactating \n\n Absence of psychological, familial, sociological or geographical condition that could potentially hamper compliance with the study protocol and follow-up schedule \n\n ", - "exclusion_criteria": ": \n\n Histopathology other than ductal adenocarcinoma pancreas \n\n Prior radiotherapy to the site of treatment \n\n Patients with unequivocal distant metastasis including liver \n\n Patients with gross peritoneal carcinomatosis on laparoscopy \n\n No prior or concurrent malignancies other than surgically treated squamous cell or basal cell carcinoma of the skin \n\n No serious medical illness which would prevent informed consent or limit survival to less than 2 years \n\n Active uncontrolled bacterial, viral or fungal infections until these conditions are corrected or controlled. \n\n Psychiatric or addictive disorders or other conditions that would preclude the patient from meeting the study requirements. \n\n Patients having metal implants, pacemakers or clustered markers. \n\n Metallic endobiliary stenting would be a contraindication, hence plastic stents may be used if biliary drainage is indicated. \n\n Patient with a history of myocardial infarction within the past 12 months \n\n No connective disease disorders that contraindicate radiotherapy, e.g., Scleroderma \n\n Pre-existing grade 2 peripheral neuropathy \n\n Any known contraindication or hypersensitivity to the chemotherapeutic agents \n\n Pregnancy, lactation period or lack of reliable contraception \n\n Any other disease or therapy, which, present a risk to the patient or which are not compatible with the aims of the clinical trial \n\n Patients would express their inability to travel on their own to Kantonsspital Aarau, (KSA) for hyperthermia treatment \n\n Indications that the person concerned will be noncompliant to the clinical trial plan because of unwillingness to cooperate or difficulties in keeping the check-up appointments", - "brief_summary": "This is a phase II randomized study of concurrent chemoradiotherapy and local hyperthermia (study group) versus chemoradiotherapy alone (control group) following neoadjuvant chemotherapy in locally advanced pancreatic cancer. Each of the treatment arm would have 39 patients based on the expected overall 1 year survival advantage of +20% over the control group (p0=40%).", - "NCTID": "NCT02439593" - } - ], - "1": [ - { - "brief_title": "Multi-institutional Trial of Non-operative Management of Appendicitis", - "phase": "", - "drugs": "['Non-operative']", - "drugs_list": [ - "Non-operative" - ], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "1076.0", - "inclusion_criteria": "inclusion criteria: \n\n English and non-English speaking patients \n\n Age : 8-17 years \n\n US or CT confirmed early appendicitis with US showing hyperemia, \u2264 1.1 cm in diameter, compressible or non-compressible, no abscess, no fecalith, no phlegmon or CT showing hyperemia, fat stranding, \u2264 1.1 cm in diameter, no abscess, no fecalith, no phlegmon \n\n White Blood Cell count > 5,000/\u00b5L and \u2264 18,000/\u00b5L \n\n Abdominal pain \u2264 48hours prior to receiving antibiotics \n\n ", - "exclusion_criteria": ": \n\n History of chronic intermittent abdominal pain \n\n Pain > 48 hours prior to first antibiotic dose \n\n Diffuse peritonitis \n\n Positive urine pregnancy test \n\n White Blood Cell \u2264 5,000/\u00b5L or \u2265 18,000/\u00b5L \n\n Presence of a fecalith on imaging \n\n Evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon \n\n Communication difficulties (e.g. severe developmental delay)", - "brief_summary": "A successful non-operative management strategy for early appendicitis will decrease the number of children requiring surgery and may improve the quality of care related to the treatment of appendicitis. To account for the child-family perspective and treatment preferences, the investigators will perform a study in which patients and their families choose between antibiotics alone (Non-operative group) or appendectomy (Surgery group) at ten U.S. hospitals. This study will determine the effectiveness of non-operative management of early appendicitis with antibiotics alone in children and compare differences in morbidity, disability, quality of life, satisfaction, and cost between families choosing surgery or non-operative management.", - "NCTID": "NCT02271932" - }, - { - "brief_title": "Fast Track Appendectomy for Suppurative Appendicitis", - "phase": "", - "drugs": "['Patients discharged home the same day following appendectomy']", - "drugs_list": [ - "Patients discharged home the same day following appendectomy" - ], - "diseases": "['Suppurative Appendicitis']", - "diseases_list": [ - "Suppurative Appendicitis" - ], - "enrollment": "36.0", - "inclusion_criteria": "inclusion criteria: \n\n Pediatric patients aged 5-18 \n\n Diagnosis of appendicitis and scheduled for appendectomy during the hours of 0600-1800. \n\n Intraoperative findings of suppurative appendicitis \n\n ", - "exclusion_criteria": ": \n\n Pregnancy \n\n Complex medical history not appropriate for same day discharge", - "brief_summary": "The literature has reported that fast track surgery can be safely applied to children undergoing appendectomy for acute appendicitis. There is no current evidence regarding the application of same day discharge protocol in children with intra-operative findings of suppurative appendicitis. The current standard of care for patients who present with intra-operative findings of suppurative appendicitis includes post-operative admission and treatment with intravenous antibiotics. Patients are discharged home once they have met the following discharge criteria: temperature less than 38.5 degrees Celsius, pain control with oral pain medication, and tolerating a liquid diet. Given the evidence in the literature that has shown that same day discharge of patients with acute appendicitis is safe and effective, we propose that fast track surgery protocol can be safely applied to patients with intraoperative findings of suppurative appendicitis. We hypothesize that this will result in a decreased postoperative length of stay, without an increase in 30-day complication rate.", - "NCTID": "NCT02137603" - }, - { - "brief_title": "Low vs. Standard Dose CT for Appendicitis Trial", - "phase": "", - "drugs": "['Diagnostic CT with low-dose radiation', 'Diagnostic CT with standard-dose radiation']", - "drugs_list": [ - "Diagnostic CT with low-dose radiation", - "Diagnostic CT with standard-dose radiation" - ], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "3074.0", - "inclusion_criteria": "inclusion criteria: \n\n Emergency department visit with suspected symptoms and signs of acute appendicitis \n\n Intravenous contrast-enhanced computed tomography examination requested due to suspicion of appendicitis \n\n Willing to provide telephone or cell phone numbers for follow-up \n\n Signed informed consent provided prior to study entry \n\n ", - "exclusion_criteria": ": \n\n Prior cross-sectional imaging tests to evaluate the presenting symptoms and signs \n\n Prior history of surgical removal of the appendix", - "brief_summary": "To determine whether low-dose (LD) CT is noninferior to standard-dose (SD) computed tomography (CT) as the first-line imaging test in adolescents and young adults in regard to negative appendectomy rate (NAR).", - "NCTID": "NCT01925014" - }, - { - "brief_title": "Nebulized Analgesia for Laparoscopic Appendectomy Trial", - "phase": "Phase 1; Phase 2", - "drugs": "['Ropivacaine', 'Normal saline']", - "drugs_list": [ - "Ropivacaine", - "Normal saline" - ], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Children and adolescents aged 7-18 years old \n\n ASA Score I (American Society of Anesthesiologists classification) [Appendix 1]: a normal healthy patient. \n\n ASA Score II (American Society of Anesthesiologists classification): A patient with mild systemic disease \n\n Patients scheduled for laparoscopic appendectomy surgery \n\n Uncomplicated appendicitis \n\n Hemodynamically stable patient \n\n No evidence of appendiceal perforation based on preoperative clinical and imaging assessment \n\n Diagnosed to have simple acute appendicitis by intraoperative laparoscopy \n\n Patients who have provided a written informed assent \n\n Caregivers who have provided a written informed consent \n\n ", - "exclusion_criteria": ": \n\n ASA Score III (American Society of Anesthesiologists classification): A patient with severe systemic disease \n\n ASA Score IV (American Society of Anesthesiologists classification): A patient with severe systemic disease that is a constant threat to life \n\n ASA Score V (American Society of Anesthesiologists classification): A moribund patient who is not expected to survive without the operation \n\n Hemodynamically unstable patient \n\n Evidence of appendiceal perforation on based on preoperative clinical and imaging assessment \n\n Perforated or gangrenous appendicitis diagnosed during laparoscopic surgery \n\n Postoperative admission in an intensive care unit with sedation or ventilatory assistance \n\n Cognitive impairment or mental retardation \n\n Progressive degenerative diseases of the CNS \n\n Seizures or chronic therapy with antiepileptic drugs \n\n Severe hepatic or renal impairment \n\n Allergy to one of the specific drugs under study \n\n Alcohol or drug addiction \n\n Failure to successfully undergo a laparoscopic appendectomy \n\n A significant communication problem including language barrier, precluding phone follow up \n\n Participation in a concomitant research study \n\n Inability to assure complete follow up \n\n Failure to acquire informed consent and assent", - "brief_summary": "The objective of this study is to assess whether the administration of nebulized intra-peritoneal ropivacaine at the onset of surgery, compared with nebulized saline, reduces morphine consumption after laparoscopic appendectomy surgery in children and adolescents.", - "NCTID": "NCT02624089" - }, - { - "brief_title": "Prophylaxis With Single Versus Five Dose of Antibiotic Therapy as Treatment of Patients With Gangrenous Acute Appendicitis", - "phase": "", - "drugs": "['prophylaxis', 'therapy']", - "drugs_list": [ - "prophylaxis", - "therapy" - ], - "diseases": "['Gangrenous Appendicitis']", - "diseases_list": [ - "Gangrenous Appendicitis" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n patients with diagnosis of acute appendicitis with intraoperative finding of a gangrenous appendix who accepted to enter the study \n\n ", - "exclusion_criteria": ": \n\n patients under 12 or older 65 years old \n\n Patients with possible immunosuppression such as diabetes, cancer, kidney failure, liver failure \n\n Pregnancy \n\n Patients who have received antibiotic treatment within seven days before surgery \n\n Patients difficult to monitor or follow up", - "brief_summary": "A prospective, randomized controlled clinical trial was conducted at the Hospital Universitario de Santander to test the effectiveness of providing a single 1-dose therapy of antibiotic prophylaxis versus a 5-day antibiotic therapy in patients with acute gangrenous appendicitis.", - "NCTID": "NCT01115153" - }, - { - "brief_title": "Appendicitis With Medical Treatment", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria:patients with appendicitis, not receiving operation - \n\n ", - "exclusion_criteria": ":nil \n\n -", - "brief_summary": "prospective study to collect data of patients with appendicitis, not receiving operation", - "NCTID": "NCT00172822" - }, - { - "brief_title": "Diagnostic Accuracy of Serum Bilirubin in the Prediction of Perforated Appendicitis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "500.0", - "inclusion_criteria": "inclusion criteria: \n\n all patients undergoing appendectomy for suspected appendicitis \n\n ", - "exclusion_criteria": ": \n\n preexisting liver disease", - "brief_summary": "Hyperbilirubinemia is reported to be a positive predictor in diagnosing perforated appendicitis. Therefore we analysed the diagnostic accuracy of serum bilirubin in discriminating between perforated and simple/no appendicitis.~Methods:~All consecutive patients undergoing appendectomy for suspected appendicitis from May 2009 to August 2011 were analysed. Primary endpoint was the diagnostic accuracy of serum bilirubin levels to detect perforated appendicitis.", - "NCTID": "NCT01698099" - }, - { - "brief_title": "The Hospital Volume Relationship in Appendicectomy Outcomes", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "40000.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients, of all ages, undergoing appendicectomy (OPCS code H01) during the time period January 2001 - December 2010. \n\n ", - "exclusion_criteria": ": \n\n Patients undergoing appendicectomy for whom this is incidental to a more major abdominal procedure. \n\n Patients non-resident in Scotland", - "brief_summary": "Background~Appendicitis is a common condition which represents a significant resource burden for the Scottish National Health Service (NHS). It is unknown whether there are significant differences in Scottish appendicectomy (appendectomy) outcomes which may be explained by hospital volume. In many studies, hospital procedural volume has been shown to be predictive of surgical outcomes.~Aims~The aim of this study is to compare appendicectomy outcomes in Scotland as they vary by hospital procedural volume.~Methods~This research study is a retrospective observational enquiry which will utilise administrative data from the Information Services Division (ISD) of NHS National Services Scotland. Patient episodes will be identified by a procedure codes for appendicectomy. A 10 year period will be studied, from January 2001 to December 2010.~Primary outcome measures will be risk-adjusted 30 day/inpatient mortality, 30 day readmission rate, 30 day re-operation rate, length of stay and negative appendicectomy rate.", - "NCTID": "NCT02018016" - }, - { - "brief_title": "Geographic Influences on Appendicectomy Outcomes", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "40000.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients, of all ages, undergoing appendicectomy (OPCS code H01) during the time period January 2001 - December 2010. \n\n ", - "exclusion_criteria": ": \n\n Patients undergoing appendicectomy for whom this is incidental to a more major abdominal procedure. \n\n Patients non-resident in Scotland.", - "brief_summary": "Introduction~Appendicitis is a common condition which represents a significant resource burden for the Scottish National Health Service (NHS). It is unknown whether there are significant differences in outcomes following appendicectomy which may be explained by geographic factors.~Aims~The aim of this study is to describe appendicectomy outcomes in Scotland as they vary by the urban-rural nature of the patient's home location and travel time from hospital.~Methods~This research study is a retrospective observational enquiry which will utilise administrative data from the Information Services Division (ISD) of NHS National Services Scotland. Patient episodes will be identified by a procedure code for appendicectomy, and the urban-rural classification of patients will be derived from postcode data. Travel time from hospital will also be estimated through postcode data. The investigators will study a 10 year period from January 2001 to December 2010.~Primary outcome measures will be risk-adjusted 30 day/inpatient mortality, 30 day readmission rate, 30 day re-operation rate, length of stay and negative appendicectomy rates.", - "NCTID": "NCT02017951" - } - ], - "2": [ - { - "brief_title": "Study on the Difference of Axilo-rectal Temperature in Appendicitis", - "phase": "", - "drugs": "['Observation and measurement of axilo-rectal temperature']", - "drugs_list": [ - "Observation and measurement of axilo-rectal temperature" - ], - "diseases": "['Appendicitis', 'Gastroenteritis']", - "diseases_list": [ - "Appendicitis", - "Gastroenteritis" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with acute appendicitis \n\n Patients with acute gastroenteritis \n\n Patients older than 15 years of age \n\n ", - "exclusion_criteria": ": \n\n Other acute abdominal diseases", - "brief_summary": "The investigators are studying prospectively the difference in axilo-rectal temperature in patients with acute appendicitis and using as a control group patients consulting with acute gastroenteritis at our emergency unit.", - "NCTID": "NCT00674726" - }, - { - "brief_title": "EHR-based Decision Support for Pediatric Acute Abdominal Pain in Emergency Care", - "phase": "", - "drugs": "['Appy CDS']", - "drugs_list": [ - "Appy CDS" - ], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "5940.0", - "inclusion_criteria": "inclusion criteria: \n\n children and adolescents ages 5-20 years with abdominal pain \n\n internal med, family med, or emergency med trained providers at participating EDs \n\n ", - "exclusion_criteria": ": \n\n select comorbid conditions \n\n previous abdominal surgery \n\n treated for select comorbid conditions", - "brief_summary": "Although appendicitis is the most common surgical emergency in children, its diagnosis remains a challenge and thus, emergency department (ED) providers increasingly rely on computed tomography to distinguish appendicitis from other conditions. This project (a) uses electronic health record (EHR) technology to deliver patient-specific clinical decision support to ED providers at the point of care, (b) assesses the impact of this intervention on the use of diagnostic imaging and clinical outcomes, and (c) assesses the impact of the intervention on the costs of care delivered. This innovative project will be a template for extending EHR-based clinical decision support to other domains of emergency care to ultimately improve a broad range of pediatric acute care outcomes.~The proposed intervention, referred to as appy-CDS, is specifically designed for widespread use in EDs and could reduce reliance on advanced diagnostic imaging for pediatric and adolescent patients with acute abdominal pain while maintaining or improving clinical outcomes. Investigators aim to develop and implement an interactive, evidence-based clinical decision support tool to optimize care for children and adolescents presenting to a general or non-pediatric ED with acute abdominal pain.", - "NCTID": "NCT02633735" - }, - { - "brief_title": "Non Operative Treatment for Acute Appendicitis", - "phase": "Phase 4", - "drugs": "['Amoxicillin and Clavulanic Acid']", - "drugs_list": [ - "Amoxicillin and Clavulanic Acid" - ], - "diseases": "['Lower Abdominal Pain', 'Right Iliac Fossa Pain', 'Acute Appendicitis']", - "diseases_list": [ - "Lower Abdominal Pain", - "Right Iliac Fossa Pain", - "Acute Appendicitis" - ], - "enrollment": "160.0", - "inclusion_criteria": "inclusion criteria: \n\n Age >14 years \n\n Lower / RIF Abdominal Pain \n\n Clinical Suspicion of Acute Appendicitis: \n\n i.e. \n\n Alvarado Score 5-6 (equivocal for acute appendicitis) \n\n Alvarado Score 7-8 (probably appendicitis) \n\n Alvarado Score 9-10 (highly likely appendicitis) \n\n Informed consent (patient or legal representative) \n\n ", - "exclusion_criteria": ": \n\n Diffuse peritonitis \n\n Antibiotic (Penicillin) documented allergy \n\n Ongoing previously started antibiotic therapy \n\n Previous appendectomy \n\n Positive pregnancy test \n\n IBD history or suspicion of IBD recrudescence", - "brief_summary": "Case control studies that randomly assign patients to either surgical or non-surgical treatment yield a relapse rate of approximately 14% at one year. It would be useful to know the relapse rate of patients who have, instead, been selected for a given treatment based on a thorough clinical evaluation, including physical examination and laboratory results (all characteristics forming the Alvarado Score) as well as radiological exams if needed or deemed helpful. If this clinical evaluation is useful,the investigators would expect patient selection to be better than chance, and relapse rate lower than 14%. Once the investigators have established the utility of this evaluation, the investigators can begin to identify those components that have predictive value (such as blood chemistry analysis, or CT findings). This is the first step toward developing an accurate diagnostic-therapeutic algorithm which will avoid the risks and costs of needless surgery.~This will be a single-cohort prospective interventional study. It will not interfere with the usual procedures, consisting of clinical examination in the Emergency Department (ED) and execution of the following exams at the physician's discretion: complete blood count with differential, C reactive protein, abdominal ultrasound, abdominal CT. Patients admitted to Emergency Department with Lower Abdominal and suspicion of Acute Appendicitis not needing immediate surgery, are requested by informed consent to undergo observation and non operative treatment with antibiotic therapy (Amoxicillin and Clavulanic Acid). The patients by protocol should not have received any previous antibiotic treatment during the same clinical episode. Patients not undergoing surgery will be physically examined 5 days later. During this follow-up visit, the patient will be given information about the study, will be invited to participate, and will be asked to sign an informed consent form. If the patient is under the age of 18 years, consent will be obtained from a parent or other legal guardian.~Telephone (or email) follow-ups will be conducted at 15 days, 6 months, and 12 months (see attached schedule) to monitor the state of the illness.", - "NCTID": "NCT01096927" - }, - { - "brief_title": "Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis", - "phase": "Phase 1", - "drugs": "['1 gm IV ertapenem at enrollment', '1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days', 'Appendectomy']", - "drugs_list": [ - "1 gm IV ertapenem at enrollment", - "1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days", - "Appendectomy" - ], - "diseases": "['Acute Uncomplicated Appendicitis']", - "diseases_list": [ - "Acute Uncomplicated Appendicitis" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult or child ages \u22655 years; \n\n Diagnosis of acute uncomplicated appendicitis, confirmed by CT, ultrasound and/or MRI performed within 24 hours of consent, as read by an attending radiologist, and confirmed by consultation of an attending surgeon; \n\n Ability to provide written informed consent (and for subjects ages 5-17, consent from their parent/guardian and assent if applicable); and \n\n Negative pregnancy test for subjects who are women of childbearing potential. \n\n ", - "exclusion_criteria": ": \n\n instability/severe sepsis, appendiceal perforation by imaging, serious co-morbidities limiting randomization, pregnancy, and inability to complete the treatment protocol.", - "brief_summary": "The major goal of the project is to demonstrate the feasibility of conducting a multi-center randomized clinical trial of antibiotic therapy versus appendectomy for the treatment of patients with acute uncomplicated appendicitis by conducting a single-site pilot study so as to optimize the chance of a large multi-center clinical trial's future success.", - "NCTID": "NCT02447224" - }, - { - "brief_title": "Point of Care 3D Ultrasound for Pediatric Appendicitis: a Pilot Study", - "phase": "", - "drugs": "['ultrasound']", - "drugs_list": [ - "ultrasound" - ], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "19.0", - "inclusion_criteria": "inclusion criteria: \n\n Potential subjects must be 0-18 years of age, presenting to the pediatric emergency department for evaluation of right lower abdominal pain and suspected appendicitis. \n\n The clinical diagnostic plan before subject enrollment must include abdominal ultrasound and/or abdominal CT. \n\n ", - "exclusion_criteria": ": \n\n Because ultrasound does not involve the use of ionizing radiation or contrast agents, it is not contraindicated in any patients, although image quality may be nondiagnostic in obese patients. The focus of this study is on acquisition of research 3D POC US images to determine feasibility of use in pediatric patients with suspected appendicitis. \n\n Patients with BMI >30 or mass >70kg, as these patients are anticipated to have nondiagnostic ultrasound images. \n\n Ultrasound also requires a gel material be applied to the skin surface as an acoustic transmission medium. Allergy to such gel will be an exclusion criterion.", - "brief_summary": "Purpose and Objective: The purpose of this study is to test the feasibility of rapid acquisition of point of care 3D ultrasound for pediatric appendicitis. The study will use a newly developed acquisition method and post-processing technique to create three dimensional image models of the abdomen.~Study activities and population group. The study population will be a convenience sample of patients 18 years and younger with suspected appendicitis, whose clinical care (unrelated to the study) includes ultrasound and/or CT of the abdomen. The study intervention includes acquisition of research ultrasound images, which will not be used for clinical care, and comparison of these images with clinically obtained images. Other clinical data such as surgical and pathology reports will also be reviewed. If not evident from the patient medical record, the final diagnosis will be confirmed by a telephone call to the subject 2 weeks after the initial visit.~Data analysis and risk/safety issues. This is a pilot study intended to determine feasibility and to refine image reconstruction algorithms. Research images will be compared to clinical images to determine the frequency of visualization of the appendix and whether the appendix was deemed normal or abnormal. Comparison of research images with final diagnosis will also occur. The research intervention, an ultrasound exam, has no known safety risks. The only risk to subjects is loss of confidentiality.~This study is observational, not interventional, because the experimental ultrasound will be performed in all subjects and will not be used in the clinical care of patients (consequently, will not have the opportunity to affect clinical outcomes). Experimental images will be reviewed after completion of clinical care and will not be provided to the clinicians caring for the subjects. We are not measuring the effect of the ultrasound examination on the subjects' outcomes.", - "NCTID": "NCT02507674" - }, - { - "brief_title": "Pediatric Appendicitis Pathway Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "178.0", - "inclusion_criteria": "inclusion criteria: \n\n Chief complaint of acute appendicitis \n\n ", - "exclusion_criteria": ": \n\n Patients with symptoms greater than 7 days", - "brief_summary": "The purpose of this study is to test a standardized approach for children being evaluated for appendicitis in the emergency department. This means that all doctors would use the same approach to diagnose appendicitis in children in the emergency department. This pathway uses two scoring systems to identify patients who are at high and low risks of appendicitis. These scoring systems are based on the patient's symptoms, signs the doctor finds when examining the patient, and their blood tests. The goal of this part of the study is to determine if the investigators' pathway accurately identifies patients who have appendicitis.", - "NCTID": "NCT01192620" - }, - { - "brief_title": "Abdomen CT and Open Appendicectomy\uff1aNew Diagnostic and Surgical Procedures", - "phase": "", - "drugs": "['The application of abdomen CT', 'traditional incision']", - "drugs_list": [ - "The application of abdomen CT", - "traditional incision" - ], - "diseases": "['Wound Infection', 'Complication', 'Scar']", - "diseases_list": [ - "Wound Infection", - "Complication", - "Scar" - ], - "enrollment": "730.0", - "inclusion_criteria": "inclusion criteria: \n\n patients with a clinical diagnosis of acute appendicitis \n\n ", - "exclusion_criteria": ": \n\n children under 14 are not included", - "brief_summary": "The traditional open appendectomy in the clinical effect is not prefect, and for a long time there is no measurable improvement. The application of abdomen CT before surgery provides a new approach to the incision and new perception.~In a randomized controlled trial of modified incision versus traditional incision. Length of hospital day was the primary terminus, while operating time, postoperative complication, scar and time to resume normal activity and work as secondary terminus.", - "NCTID": "NCT02574364" - }, - { - "brief_title": "Inflammatory Response in Appendicitis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "183.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with appendicitis \n\n ", - "exclusion_criteria": ": \n\n Any patient with immunosuppressive or immunodeppressive known pathological conditions \n\n Any patient with a pathological report describing a normal appendix", - "brief_summary": "Although the presence of SIRS has been described in patients with appendicitis, its progressive response related and together with progression of symptomatology from the onset of symptoms to diagnostic has not been characterized. Continuation of the systemic inflammation in patients with injury and infectious processes may result in multiple organ dysfunction and ultimately failure. As with any acute inflammatory condition, the patients' systemic inflammatory response to appendicitis will progress and become more intense with the passing of time. The purpose of this study is to characterize the systemic inflammatory response to appendicitis from the beginning of symptoms to diagnostic in patients with appendicitis submitted to emergency surgery.", - "NCTID": "NCT01718171" - }, - { - "brief_title": "Importance of Peritoneal Free Fluid Cultures in Acute Appendicitis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Appendicitis (Perforated/ Non-perforated) Free fluid Age: 6 - 90y \n\n ", - "exclusion_criteria": ": \n\n Immunosuppression (recent chemotherapy, chronic use of immunosuppressive medication) Age < 6 and > 90y", - "brief_summary": "The purpose of this study is to evaluate the frequency of positive free fluid cultures in both perforated and non-perforated appendicitis. In addition predictors of positive free fluid cultures will be analyzed.", - "NCTID": "NCT01953289" - }, - { - "brief_title": "Open Versus Laparoscopic Appendectomy", - "phase": "", - "drugs": "['open appendectomy', 'laparoscopic appendectomy']", - "drugs_list": [ - "open appendectomy", - "laparoscopic appendectomy" - ], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n age over 15 years \n\n suspected acute appendicitis \n\n suitability for laparoscopy \n\n ", - "exclusion_criteria": ": \n\n patients refusal to participate \n\n lack of a laparoscopic surgeon", - "brief_summary": "The aim of this prospective randomized trial is to compare the feasibility of open with laparoscopic appendectomy in suspected acute appendicitis. The investigators especially focused on the postoperative recovery and long-term complications.", - "NCTID": "NCT00908804" - }, - { - "brief_title": "Magnetic Resonance Imaging (MRI) of Appendicitis in Children", - "phase": "", - "drugs": "['MRI of the abdomen']", - "drugs_list": [ - "MRI of the abdomen" - ], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "21.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 8-18 years, referred from emergency department for suspected appendicitis and receiving either CT scan or ultrasound of the abdomen for diagnosis \n\n ", - "exclusion_criteria": ": \n\n Failure to pass MRI metal screening. Claustrophobia or need for sedation due to inability to hold still.", - "brief_summary": "Study to find out if MRI can diagnose appendicitis in children as well as or better than CT scan and/or ultrasound scan performed at the same time. No additional contrast material or sedation will be used to perform the MRI.", - "NCTID": "NCT00723788" - }, - { - "brief_title": "A Study Comparing Safety and Efficacy of Levofloxacin and Metronidazole Versus Piperacillin/Tazobactam in Treating Complicated Appendicitis", - "phase": "Phase 4", - "drugs": "['levofloxacin; metronidazole']", - "drugs_list": [ - "levofloxacin; metronidazole" - ], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "139.0", - "inclusion_criteria": "inclusion criteria: \n\n Two or more symptoms of acute appendicitis for at least 24 hours or radiologic evidence of complicated appendicitis \n\n Able to take medicine orally after recovering from surgery \n\n If female, using birth control \n\n ", - "exclusion_criteria": ": \n\n History of allergy to any study medication \n\n Life expectancy < 72 hours \n\n APACHE II (health) score > 25 \n\n Neutropenic (low white blood cell count) \n\n HIV positive with current or past CD4 count < 200/mm^3 \n\n Low platelet count (bleeds easily) \n\n Malnourished with low albumin \n\n Condition requiring use of major tranquilizers", - "brief_summary": "The purpose of this study is to compare the efficacy and safety of two treatment regimens in treating patients with complicated appendicitis. Appendicitis requires antibiotic treatment when the appendix ruptures (complicated appendicitis). This is a study comparing intravenous (IV) antibiotic therapy of levofloxacin/metronidazole versus piperacillin/tazobactam for 4 to 14 days. Patients may be switched to oral therapy after 48 hours, at the doctor's discretion.", - "NCTID": "NCT00236912" - } - ] - }, - { - "patient_id": "sigir-201423", - "patient": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", - "0": [ - { - "brief_title": "The Natural History of Gene Expression in the Lung Cells of Non-Smokers, Smokers and Ex-Smokers in Health and Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Pulmonary Disease (COPD)', 'Smoking', 'Smoking Cessation', 'Chronic Bronchitis', 'Emphysema']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease (COPD)", - "Smoking", - "Smoking Cessation", - "Chronic Bronchitis", - "Emphysema" - ], - "enrollment": "171.0", - "inclusion_criteria": "inclusion criteria: \n\n Group A: Healthy nonsmokers \n\n All study individuals should be enrolled in the Airway protocol #1204012331 Collection of Airway, Blood and/or Urine Specimens from Subjects for Research Studies \n\n Willing and able to provide informed consent for the long term follow up study with repeated bronchoscopies \n\n Male and Female subject \u226518 years of age \n\n Never smokers is defined as someone who has smoked < 100 cigarettes per lifetime and whose urine nicotine <2 ng/mL and/or urine cotinine <5 ng/mL, at entry into the study \n\n Group B: Healthy current smokers Inclusion: \n\n All study individuals should be enrolled in the Airway protocol \n\n Willing and able to provide informed consent for the long term follow up study with repeated bronchoscopies \n\n Male and Female subject \u226518 years of age \n\n Active smoker as evidenced by self-report and urine nicotine >30 ng/mL and/or urine cotinine >50 ng/mL \n\n Group C: Healthy smokers who elect to stop smoking Inclusion: \n\n All study individuals should be enrolled in the Airway protocol \n\n Willing and able to provide informed consent for the long term follow up study with repeated bronchoscopies \n\n Male and Female subject \u226518 years of age \n\n Current smoker as evidenced by self-report and urine nicotine >30 ng/mL and/or urine cotinine >50 ng/mL \n\n Be a current smoker willing to stop smoking \n\n Group D - Current smokers with COPD Inclusion: \n\n All study subjects will be enrolled in the Airway protocol #1204012331 Collection of Airway, Blood and/or Urine Specimens from Subjects for Research Studies \n\n All study subjects should meet the lung disease criteria for having COPD may be of any stage (GOLD I - IV), be ambulatory and have no evidence of respiratory failure \n\n All study subjects should be able to provide informed consent for the long term follow up study with repeated bronchoscopies \n\n Male and Female subject \u226518 years of age \n\n Active smokers as evidenced by urine nicotine >30 ng/mL and/or urine cotinine >50 ng/mL \n\n Group E - Current smokers with COPD who elect to stop smoking Inclusion: \n\n All study subjects will be enrolled in the Airway protocol #1204012331 Collection of Airway, Blood and/or Urine Specimens from Subjects for Research Studies \n\n All study subjects should meet the lung disease criteria for having COPD may be of any stage (GOLD I - IV), be ambulatory and have no evidence of respiratory failure \n\n All study subjects should be able to provide informed consent for the long term follow up study with repeated bronchoscopies \n\n Male and Female subject \u226518 years of age \n\n Active smokers as evidenced by urine nicotine >30 ng/mL and/or urine cotinine >50 ng/mL \n\n Be a current smoker willing to stop smoking \n\n ", - "exclusion_criteria": ": \n\n Groups A - E \n\n Individuals unable to provide proper informed consent \n\n Habitual use of drugs and/or alcohol within the past six months (Acceptable: Marijuana one time in three months; average of two alcoholic beverages per day; drug and/or alcohol abuse is defined as per the DSM-IV Substance Abuse Criteria) \n\n Individuals with asthma and with recurrent or recent (within three months) and/or acute pulmonary infection \n\n Individuals with allergy to lidocaine \n\n Significant kidney disease or subjects on dialysis \n\n Females who are pregnant or lactating or intending to become pregnant in the next 12 months \n\n Subjects who are HIV positive \n\n Subjects that have unstable coronary artery disease as evidenced by unstable angina, >Class II New York Heart Association (NYHA) cardiac status, history of congestive heart failure or MI within the last 12 months \n\n Subjects who are contraindicated for undergoing bronchoscopy \n\n Subjects having any medical condition that in the opinion of the investigator would preclude the subject from entering the study \n\n Groups D and E \n\n - Subjects may not have evidence of respiratory failure such as SpO2 <90% or PaO2 <60 mmHg \n\n Groups C and E \n\n Current major depression or other significant psychiatric disorder \n\n Subjects currently taking anti-depressant medication", - "brief_summary": "Cigarette smoking is the major risk factor for chronic obstructive pulmonary disease (COPD, commonly known as chronic bronchitis and emphysema). Despite this clear link, only 15-20% of smokers develop COPD suggesting that genetic factors affect the lung's susceptibility to the stress of cigarette smoke. The cells lining the airways (epithelium) and cells that help defend the lung (alveolar macrophages) of smokers develop gene expression changes that are different from that of nonsmokers. In the investigators' previous studies they have demonstrated that there are greater than 200 genes that are responsive to cigarette smoke in these cells. But the investigators do not know whether the gene expression is static or changes as a function of time. Genes that show significant changes over time may be relevant to the progression of the disease. Even though quitting smoking reduces the rate at which the lungs decline, many-smokers still go on to develop COPD. This study will provide insights into the natural history of smoking-related gene expression of the lung cells in health and disease.", - "NCTID": "NCT00974064" - }, - { - "brief_title": "Human Safety of Capsaicin Inhalation Challenge Testing for Young and Older Men", - "phase": "Phase 1", - "drugs": "['biological/vaccine']", - "drugs_list": [ - "biological/vaccine" - ], - "diseases": "['COPD']", - "diseases_list": [ - "COPD" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Men of ages 18 and 30 (Dates of birth 1973-1985) or 55-92 years old (Dates of birth 1911-1948). \n\n Must not currently be a cigarette smoker. If an ex-smoker then has not smoked for at least 10 years and consumption were no more than 10 pack years. \n\n Agrees to volunteers for the study and willing to sign the informed consent form. \n\n There were negative/normal screening tests for the following \n\n Responses to the questionnaire deny current and prior respiratory diseases (including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung d9sase) and no current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis). Subjects must not be taking any cardiac medications or admit to a physician-diagnosed cardiac condition. \n\n Normal spirometry measurements with FEV1 & FVC greater than 75% predicted and FEV1/FVC more than 69% \n\n Impedance oscillometry were within normal limits \n\n Negative physical examination of the chest with absence of wheezing and crackles on auscultation of the chest. \n\n Exhaled nitric oxide concentration is less than 35 ppb for younger and less than 65 ppb for older groups \n\n ", - "exclusion_criteria": ": \n\n men of: ages < 18, 31-54 and >92 years old; \n\n current cigarette smokers or exsmokers who have smoked within the past 10 years and/or smoked more than 10 pack/years; \n\n refusal to volunteer for the study and not willing to sign the informed consent form; \n\n screening test not considered normal by physician/PI and showing one or more of the following: \n\n one or more positive response to the questionnaire(e.g., current or past respiratory diseases including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung disease; and/or; current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis) and/or; admitting to taking a cardiac medication and/or; or physician-diagnosed cardiac condition (e.g., coronary heart disease, angina, myocardial infarction, valvular heart disease, cardiomyopathy, etc.); \n\n Abnormal spirometry measurements (FEV1 &/or FVC <75% predicted and FEV1/FVC <69%); \n\n Positive physical examination (performed by Physician/PI) with presence of wheezing and/or crackles on auscultation of the chest; \n\n Impulse oscillometry >4 times normal limits; \n\n Exhaled nitric oxide of >35ppb for younger group and >65 ppb for older group. -", - "brief_summary": "In 2004, the investigators initiated a human Capsaicin inhalation experiment under an Investigational New Drug (IND) protocol approved by the FDA (IND 69,642) and the subject safety procedures instituted and approved by the Institutional Review Board (IRB). As part of the study protocol, inhaled Capsaicin solutions were analyzed using high performance liquid chromatography (HPLC). The investigation employed safety procedures while conducting the human inhalation investigations. In addition, during our investigations we observed discrepancies between the predicted Capsaicin concentrations mixed by a registered pharmacist and the actual capsaicin concentrations determined by HPLC. The stability of Capsaicin solutions stored over a seven month period and refrigerated at 4degrees C and protected against ultraviolet light were examined.", - "NCTID": "NCT01621685" - }, - { - "brief_title": "Endothelial Dysfunction and Chronic Obstructive Pulmonary Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Pulmonary Disease', 'Endothelial Dysfunction']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease", - "Endothelial Dysfunction" - ], - "enrollment": "117.0", - "inclusion_criteria": "inclusion criteria: \n\n COPD patients in stable condition ( without exacerbation min 1 months ago) \n\n Over 40 years \n\n History of at least 10 py \n\n ", - "exclusion_criteria": ": \n\n acute exacerbation of COPD \n\n active malignancy \n\n autoimmune disease \n\n acute myocardial infarction \n\n diabetes mellitus with late complications \n\n congestive heart failure \n\n women of childbearing potential", - "brief_summary": "The purpose of this study is to investigate the role of endothelial dysfunction in chronic obstructive pulmonary disease.", - "NCTID": "NCT02092675" - }, - { - "brief_title": "The Role of Viral Infection in Acute Exacerbations of Non-cystic Fibrosis Bronchiectasis in Adults", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Bronchiectasis']", - "diseases_list": [ - "Bronchiectasis" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 18 years \n\n HRCT-diagnosed Bronchiectasis \n\n Capable of providing written informed consent \n\n ", - "exclusion_criteria": ": \n\n Patient judged to have poor compliance \n\n Cystic fibrosis bronchiectasis", - "brief_summary": "Bronchiectasis is clinically characterized by irreversible dilation of the bronchi and bronchioles leading to persistent cough, purulent sputum, and airway \ufb02ow limitation, which may be accompanied by recurrent exacerbations.It has been increasingly recognized that respiratory viruses are mainly responsible for acute exacerbation of chronic pulmonary diseases, i.e. asthma, chronic obstructive pulmonary disease and cystic fibrosis. However,little is known about the roles of viral infection in driving exacerbations of bronchiectasis.This study aims to identify the frequency of common viral infections and determine the roles that viruses play in acute exacerbations of bronchiectasis.", - "NCTID": "NCT01801657" - }, - { - "brief_title": "Lidocaine: Effect of Lidocaine in Chronic Cough", - "phase": "Phase 4", - "drugs": "['10 % Lidocaine', '10 % Lidocaine', '0.9% saline']", - "drugs_list": [ - "10 % Lidocaine", - "10 % Lidocaine", - "0.9% saline" - ], - "diseases": "['Chronic Cough']", - "diseases_list": [ - "Chronic Cough" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female subjects, age 18 years and over. \n\n History of cough for more than 8 weeks. \n\n Normal chest x ray \n\n Chronic idiopathic cough or chronic cough resistant to treatment of specific triggers. \n\n ", - "exclusion_criteria": ": \n\n Smoking status: \n\n Current smokers \n\n Ex smokers with history of smoking > 20 pack years or those who have given up < 6 months ago. \n\n Prohibited medications: \n\n Use of medications likely to suppress / affect cough including codeine, morphine, pregabalin, gabapentin, amitriptylline, angiotensin converting enzyme inhibitors (type 1) and baclofen. \n\n Use of any anti-arrhythmic medication. \n\n Use of cimetidine, beta blockers, or diuretics. \n\n Cardiovascular conditions: \n\n Sinoatrial disease, bradycardia or all types of heart blocks. \n\n History of ischaemic heart disease or heart failure. \n\n Clinically significant abnormal electrocardiogram (ECG) at Screening or Baseline. \n\n History of cardiac surgery \n\n Respiratory conditions: \n\n o Asthma. \n\n Central nervous system / Peripheral nervous system conditions: \n\n Epilepsy. \n\n Myasthenia gravis. \n\n Miscellaneous: \n\n History of hepatic or renal dysfunction. \n\n Porphyria \n\n History of hypersensitivity to Lidocaine or related drugs. \n\n Pregnancy or breast feeding. \n\n Participation in another trial within the preceding 6 weeks. \n\n Trauma or ulceration to oral mucosa. \n\n History of chest or upper airway infection within the past 6 weeks. \n\n Conditions which may affect cough response such as stroke, diabetes, Parkinson's Disease.", - "brief_summary": "People cough in order to clear their airways. Most coughs are caused by viruses and settle down by themselves, but some people develop persistent coughing which can be anywhere from 8 weeks to several years. This is called chronic cough. People with chronic cough find the symptom distressing and it can have a major impact on their quality of life. Patients with chronic cough often report a sensation at the back of their throat which makes them feel an urge to cough. There is some evidence that Lidocaine (an anaesthetic used during medical procedures) can suppress a person's cough when given to patients via a nebuliser (a machine that turns liquid into a fine mist).~It is currently unknown whether using a local anaesthetic, such as Lidocaine, in the form of a throat spray would successfully suppress a person's cough. A throat spray would be an easier treatment option in chronic cough patients. Thus, the investigators research aims to compare cough rates, severity and urge to cough scores between Lidocaine throat spray and nebulised Lidocaine.", - "NCTID": "NCT01252225" - }, - { - "brief_title": "Heliox-Driven Racemic Epinephrine in Treatment of Bronchiolitis in Pediatric ED Patients", - "phase": "Phase 3", - "drugs": "['heliox', 'oxygen']", - "drugs_list": [ - "heliox", - "oxygen" - ], - "diseases": "['Bronchiolitis']", - "diseases_list": [ - "Bronchiolitis" - ], - "enrollment": "72.0", - "inclusion_criteria": "inclusion criteria: \n\n Any child 2-12 months old seen in the emergency department. \n\n A clinical bronchiolitis score > 3 by modified Wood's Clinical Bronchiolitis Score (M-WCBS). \n\n Diagnostic criteria of bronchiolitis includes tachypnea, cough, prolonged expiratory phase, wheezing, rales, chest retractions, and hyperinflation of lungs on chest radiograph. After consenting a patient to the study, respiratory syncytial virus (RSV) infection will be tested by rapid enzyme-linked immunoabsorbent assay of nasal secretions. \n\n ", - "exclusion_criteria": ": \n\n No child will be excluded based on race or gender \n\n Patients under the age of 2 months or greater than 12 months \n\n Patients with cyanotic heart disease \n\n Patients with lobar pneumonia, defined by results of chest radiographs. \n\n The presence of interstitial disease or diffuse patchy marking consistent with atelectasis on chest radiographs will not exclude patients. \n\n Patients with croup. \n\n Patients with foreign body aspiration. \n\n Patients with history of cystic fibrosis, bronchopulmonary dysplasia or other chronic lung disease. \n\n Patients with liver or renal disease. \n\n Patients with sickle cell anemia. \n\n Patients requiring mechanical ventilation. \n\n Patients who develop supraventricular tachycardia secondary to racemic epinephrine administration. \n\n Patients with tracheomalacia or bronchomalacia. \n\n Patients who had received bronchodilators within 2 hours of initiation of the study. \n\n Patients who had received systemic corticosteroids within 72 hours of enrollment \n\n Patients who suffered from persistent airway hyperreactivity in the 3 months before the study. \n\n Patients who do not tolerate the nasal cannulae for 45 out of 60 minutes.", - "brief_summary": "The purpose of this study is to assess whether children with moderate to severe bronchiolitis treated with standard racemic epinephrine therapy via 70:30 helium-oxygen (heliox) driven nebulization will have improvements in measurements of airway more rapidly than those treated with conventional air-oxygen driven nebulization.", - "NCTID": "NCT00116584" - }, - { - "brief_title": "Randomized Controlled Trial (RCT) in Children With Severe Pneumonia", - "phase": "", - "drugs": "['Day-care treatment vs. hospital care']", - "drugs_list": [ - "Day-care treatment vs. hospital care" - ], - "diseases": "['Severe Pneumonia']", - "diseases_list": [ - "Severe Pneumonia" - ], - "enrollment": "368.0", - "inclusion_criteria": "inclusion criteria: \n\n Age: 2 to 59 months \n\n Sex: Both boys and girls \n\n Severe pneumonia according to WHO criteria (Severe pneumonia is defined as cough or difficult breathing with lower chest wall in drawing with or without fast breathing which is defined as the respiratory rate \u2265 50 breaths per minute for children aged 2-11 months and \u2265 40 breaths per minute for children aged 12-59 months) \n\n Attend the Radda Clinic and ICHSH between 8:00 am to 4:00 pm (Sunday through Saturday) \n\n Written informed consent by respective parents/guardians \n\n ", - "exclusion_criteria": ": \n\n Very severe and non-severe pneumonia \n\n Nosocomial pneumonia \n\n History of taking antibiotics for pneumonia within 48 hour prior to enrollment \n\n Chronic illnesses like tuberculosis, cystic fibrosis \n\n Congenital deformities/anomalies e.g. Down's Syndrome, congenital heart disease \n\n Immunodeficiency \n\n Trauma/burn \n\n Bronchiolitis \n\n Bronchial asthma \n\n Lives far away from the Radda Clinic and ICHSH (outside 5 km radius from the respective study site) \n\n Parents/guardians not consenting for inclusion of their children in the study", - "brief_summary": "Pneumonia is the leading cause of childhood morbidity and death in many developing countries including Bangladesh, causing about 2 million deaths worldwide each year. Pneumonia is an infection of the lungs, most commonly caused by viruses or bacteria like Streptococcus pneumoniae and Haemophilus influenzae. Depending on the clinical presentation, pneumonia can be classified as very severe, severe or non-severe, with specific treatment for each of them except for antibiotic therapy. Severe and very severe pneumonia require hospitalization for additional supportive treatment such as suction, oxygen therapy and administration of bronchodilator. In Bangladesh, the number of hospital beds is inadequate for admission of all pneumonia cases that require hospitalization; however, it is also important to provide institutional care to those children who cannot be hospitalized due to bed constraints. Provision of appropriate antibiotics and supportive cares during the period of stay at established day-care centres could be an effective alternative. The impetus for this study came from the findings of our recently completed study titled Daycare-based management of severe pneumonia in under-5 children when hospitalization is not possible due to the lack of beds. This study successfully managed children (n=251), but it was not a randomized trial and thus direct comparison of the efficacy of management of severe pneumonia at the day-care centre, essential for building confidence for implementing this management policy, is not possible. We, the researchers at the International Centre for Diarrhoeal Disease Research, Bangladesh, could not plan a randomized, controlled trial (RCT) because of ethical reasons. Now that we have data suggesting effectiveness as well as safety of the day-care based treatment for management of children with severe pneumonia, a RCT should be possible. Two hundred fifty-one children with severe pneumonia were enrolled at the Radda Clinic from June 2003 to May 2005. The mean age was 7\u00b17 (2-55) months, 86% infants, 63% boys and 91% breast-fed. History of cough was present in 99% cases, fever in 89% and rapid breathing in 67% cases. Forty-four percent of children were febrile (\u226538\u00b0C), 93% children had vesicular breath sound and 99% bilateral rales. Fifty-seven percent of children were hypoxic with mean oxygen saturation of (93\u00b14)%, which was corrected by oxygen therapy (98\u00b13)%. Eighty percent of children had severe pneumonia and 20% had very severe pneumonia. The mean duration of clinic stay was (7\u00b12) days. Two hundred thirty-four (93%) children completed the study successfully, 11 (4.4%) referred to hospitals (only one participant had to visit hospital at night due to deterioration of his condition, 9 were referred to hospital at the time of clinic closure i.e., at 5 pm and one participant was referred to hospital during the morning hours) and 6 (2.4%) left against medical advice (LAMA). There was no death during the period of clinic stay but only four (1.6%) deaths occurred during the 3 months follow-up. The study indicated that treatment of severe pneumonia in children at the day-care centre is effective and safe and thus it is comparable to the hospital care. If the day-care based management is found to have comparable efficacy to that of hospitalized management of severe pneumonia in children then they could be managed at outpatient, day-care set ups reducing hospitalization and thus freeing beds for management of other children who need hospitalized care. Additionally, availability of the treatment facility in community set-ups will be cost and time saving for the population. Children of either sex, aged 2-59 months, attending the Radda Clinic and Institute of Child Health and Shishu Hospital (ICHSH) with severe pneumonia will be randomized to receive either the day-care management at the clinic or hospitalized management at the ICHSH. Children randomized to receive day-care treatment will stay at the clinic from 8 am-5 pm and will receive antibiotics and other supportive cares. At 5 pm, they would be send to respective homes with advice to bring back their children to the clinic next morning, and advised to provide other supports at home. The same management would be continued till improvement and discharged and followed up every 2 weeks for 3 months. Children randomized to receive hospitalized management would be admitted at ICHSH and receive standard treatment like antibiotics and other supportive cares. The same treatment would be continued for 24 hours/day (rather than 9 hours/day at the day-care clinic) till improvement and discharged and followed-up at the ICHSH every 2 weeks for 3 months. About 3000 children with pneumonia visit Radda Clinic each year and about 200 of them will have severe pneumonia requiring hospitalization. Thus, we hope to enroll 368 (184 in each site) children with severe pneumonia during a 2-year study period.", - "NCTID": "NCT00455468" - }, - { - "brief_title": "Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia", - "phase": "Phase 2; Phase 3", - "drugs": "['Solithromycin', 'Standard of Care']", - "drugs_list": [ - "Solithromycin", - "Standard of Care" - ], - "diseases": "['Community-acquired Bacterial Pneumonia']", - "diseases_list": [ - "Community-acquired Bacterial Pneumonia" - ], - "enrollment": "97.0", - "inclusion_criteria": "inclusion criteria: \n\n History of and/or documented fever (rectal, ear, or oral temperature \u226538\u00b0C or axillary temperature \u226537.5\u00b0C) or hypothermia (rectal, ear, or oral temperature <35\u00b0C or axillary temperature <34.5\u00b0C) \n\n Chest radiograph infiltrates consistent with bacterial pneumonia (or pneumonia caused by atypical bacterial agents); if a subject is outpatient and starting on oral therapy, a radiograph is not required. \n\n Presence of at least 2 of the following signs or symptoms: \n\n Cough \n\n Difficulty breathing \n\n Production of purulent sputum \n\n Chest pain \n\n Grunting \n\n Hypotension \n\n Tachycardia, defined as follows: \n\n 2 months to <24 months: \u2265160 beats/min 24 months to <10 years: \u2265140 beats/min \n\n 10 years: \u2265100 beats/min \n\n Tachypnea, defined as follows: \n\n 2 months to <12 months: \u226550 breaths/min 12 months to <5 years: \u226540 breaths/min \n\n 5 years: \u226520 breaths/min \n\n Physical exam consistent with pulmonary consolidation \n\n Presence of at least 1 of the following: \n\n Leukocytosis (\u226512,000 white blood cells [WBC]/mm3) \n\n Leukopenia (<5000 WBC/mm3) \n\n \u226510% immature neutrophils (bands) regardless of total peripheral WBC \n\n Elevated inflammatory markers (C-reactive protein or procalcitonin) \n\n Oxygen saturation <97% on room air \n\n Organism consistent with a typical respiratory pathogen identified \n\n ", - "exclusion_criteria": ": \n\n Ventilator-associated or hospital-acquired pneumonia \n\n >48 hours of systemic antibacterial therapy \n\n confirmed or suspected bacterial meningitis \n\n breast-feeding females \n\n positive pregnancy test", - "brief_summary": "This is a phase 2/3, randomized, open-label, active control, multi-center study to assess the safety and efficacy of solithromycin in children and adolescents with community-acquired bacterial pneumonia (CABP).", - "NCTID": "NCT02605122" - }, - { - "brief_title": "Bi-Level Positive Airway Ventilation for Acute Chest Syndrome", - "phase": "", - "drugs": "['Bi-level positive airway pressure device', 'Sham CPAP']", - "drugs_list": [ - "Bi-level positive airway pressure device", - "Sham CPAP" - ], - "diseases": "['Sickle Cell Anemia', 'Acute Chest Syndrome']", - "diseases_list": [ - "Sickle Cell Anemia", - "Acute Chest Syndrome" - ], - "enrollment": "3.0", - "inclusion_criteria": "inclusion criteria: \n\n patients diagnosed with Hemoglobin SS (HB SS), the most common type of sickle cell disease \n\n patients diagnosed with Hemoglobin SC (HB SC), the second most common type of sickle cell disease. \n\n patients diagnosed with Hemoglobin sickle beta-zero thalassemia ( HB SB0thal) or Hemoglobin sickle thalassemia (HB SBthal) \n\n Must meet clinical criteria for ACS- an infiltrate on Chest X-ray and one of the following: \n\n Respiratory symptoms/signs (patients pulse oximetry < 92% or oxygen saturation < 2% below their baseline, tachypnea, cough, and increased work of breathing) \n\n Fever \n\n Chest pain AND \n\n Patients' eligible for a simple transfusion based on one of the following criteria: \n\n Hypoxemia (patients pulse oximetry < 92% or oxygen saturation < 2% below their baseline) \n\n Hemoglobin < 5 gm/dl \n\n Increased work of breathing \n\n ", - "exclusion_criteria": ": \n\n Patient requires exchange transfusion within first 24 hours of admission \n\n Patient requires PCCU transfer within first 24 hours of admission \n\n Hemoglobin > 9gm/dl secondary to these patients requiring an exchange transfusion", - "brief_summary": "Acute chest syndrome (ACS) is a frequent complication of sickle cell disease and is diagnosed by having findings on a chest x-ray and one of the following: chest pain, fever, or trouble breathing. Patients with Acute Chest Syndrome can get very sick and require an exchange transfusion (special large blood transfusion) and mechanical ventilation. Bi-level Positive Airway Pressure (also known as BLPAP or BiPAP) is a device that blows air into a patients lungs via a mask that covers the nose. The goal of this study is to determine whether giving children BiPAP when they have ACS, in addition to providing standard clinical care for ACS, alters the clinical course of these patients. The investigators hypothesize that patients receiving effective BiPAP will have milder clinical courses resulting in shorter hospital stays and fewer transfers to the intensive care unit and exchange transfusions.", - "NCTID": "NCT01589926" - }, - { - "brief_title": "Diagnosing Pneumonia Under Low-resource Conditions", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Asthma', 'Pneumonia', 'Bronchiolitis']", - "diseases_list": [ - "Asthma", - "Pneumonia", - "Bronchiolitis" - ], - "enrollment": "502.0", - "inclusion_criteria": "inclusion criteria: \n\n All children below 5 exceeding WHO age-dependent tachypnea criteria. \n\n ", - "exclusion_criteria": ": \n\n None", - "brief_summary": "Pneumonia is the commonest cause of death in children worldwide, killing 1.5 million children under the age of 5 years, every year. This is more than the number of children dying from AIDS, malaria and tuberculosis combined. The current diagnostic and management protocols for managing serious respiratory diseases in children are 30 years old and are greatly in need of updating. The successful establishment of useful clinical management criteria for children with respiratory diseases will have benefits for children in low resource regions around the world. The goals of the study are:~To determine if children with respiratory distress can be reliably diagnosed under low-resource conditions.~To identify the clinical tests that best differentiate pneumonia from wheezy diseases. These will be used to establish updated diagnostic criteria for common pediatric lung diseases that broaden the current pneumonia algorithm by adding another for wheezy illnesses.~The ultimate objective is to improve the management and outcome of acute respiratory conditions in children.~Investigators also wish to test the efficacy of a locally developed cell phone oximeter probe in a low resource setting.", - "NCTID": "NCT01997047" - }, - { - "brief_title": "Standard Medical Care or Urgent Chest X-ray in Diagnosing Lung Cancer in Smokers With Chest Symptoms Who Are Older Than 60 Years", - "phase": "", - "drugs": "['caregiver-related intervention or procedure', 'questionnaire administration', 'quality-of-life assessment', 'radiography']", - "drugs_list": [ - "caregiver-related intervention or procedure", - "questionnaire administration", - "quality-of-life assessment", - "radiography" - ], - "diseases": "['Lung Cancer', 'Tobacco Use Disorder']", - "diseases_list": [ - "Lung Cancer", - "Tobacco Use Disorder" - ], - "enrollment": "386.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Patients over 60 seeing a participating General Practitioner \n\n Currently smokes 10 or more pack years, meeting at least one of the following criteria: \n\n New or altered cough of any duration reported to primary care \n\n Increased breathlessness or wheezing (with or without purulent sputum) \n\n Do not qualify for an urgent referral for a chest x-ray under the National Institute for Health and Clinical Excellence (NICE) guidelines (i.e., hemoptysis or unexplained or persistent [lasting > 3 weeks] signs or symptoms), including having any of the following: \n\n Cough \n\n Chest/shoulder pain \n\n Dyspnea \n\n Weight loss \n\n Chest signs \n\n Hoarseness \n\n Finger clubbing \n\n Features suggestive of metastasis from a lung cancer (e.g., in the brain, bone, liver, or skin) \n\n Cervical/supraclavicular lymphadenopathy \n\n PATIENT CHARACTERISTICS: \n\n Not specified \n\n PRIOR CONCURRENT THERAPY: \n\n No chest x-ray within in past 3 months \n\n No need for a chest x-ray within the next 3 weeks for reasons other than those listed under Disease Characteristics", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Diagnostic procedures, such as an urgent chest x-ray, may help in planning cancer treatment. It is not yet known whether standard medical care is more effective than an urgent x-ray in diagnosing lung cancer in smokers with chest symptoms who are older than 60 years.~PURPOSE: This randomized clinical trial is studying standard medical care to see how well it works compared with an urgent chest x-ray in diagnosing lung cancer in smokers with chest symptoms who are older than 60 years.", - "NCTID": "NCT01344005" - }, - { - "brief_title": "Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Children in the Paediatric A&E.", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Community-Acquired Infections', 'Respiratory Tract Infections', 'Sepsis', 'Urinary Tract Infections', 'Meningitis', 'Gastroenteritis']", - "diseases_list": [ - "Community-Acquired Infections", - "Respiratory Tract Infections", - "Sepsis", - "Urinary Tract Infections", - "Meningitis", - "Gastroenteritis" - ], - "enrollment": "1500.0", - "inclusion_criteria": "inclusion criteria: \n\n Children aged 1 month to 16 years \n\n Acute illness episode of maximum 5 days \n\n ", - "exclusion_criteria": ": \n\n recent trauma \n\n neurological conditions \n\n intoxication \n\n psychiatric of behavioural disorders without a somatic cause \n\n acute exacerbation of a chronic condition (asthma, known immunodeficiency, diabetes, cystic fibrosis, etc)", - "brief_summary": "Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Acutely Ill Children in a High Prevalent Setting: The Paediatric Accidents & Emergencies through prospective observational data collection concerning specific items from the clinical and technical examination in diagnosing serious infections, such as meningitis, sepsis, pneumonia, pyelonephritis, bronchiolitis with hypoxia. Eventually we will attempt to validate a vital signs and symptoms rule derived from multiple low to high prevalent settings of acutely ill children.", - "NCTID": "NCT01396798" - }, - { - "brief_title": "To Evaluate the Use of ASTHMA IQ in a Primary Care Setting", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "375.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female patients, age 12 through 65 years at the time of screening; \n\n Written informed consent obtained from the patient prior to beginning study procedures; \n\n Documented clinical history of chronic persistent asthma requiring controller therapy; \n\n Able to complete the study period, including follow-up period, of up to approximately 2 years; and \n\n Willing to forego other forms of experimental treatment and study procedures during the study and for 30 days after the follow-up period is completed. \n\n ", - "exclusion_criteria": ": \n\n History of any disease, evidence of any current disease (other than asthma), any finding upon physical examination, or any laboratory abnormality, that, in the opinion of the investigator, may compromise the safety of the patient in the study or confound the analysis of the study; \n\n Lung disease other than asthma (e.g., chronic obstructive pulmonary disease, cystic fibrosis); \n\n Any disease or illness, other than asthma, that is likely to require the use of systemic corticosteroids during the study period; \n\n Current acute illnesses or evidence of significant active infection, such as fever \u2265 38.0\u00b0C (100.5\u00b0F) within 4 weeks of enrollment; \n\n Receipt of any investigational drug therapy within 30 days or any biologic(s) within 5 half-lives prior to screening, except omalizumab for asthma; \n\n Pregnancy at enrollment; \n\n Breastfeeding or lactating females; \n\n Elective major surgery planned from screening through study completion; \n\n History of cancer other than basal cell carcinoma of the skin or cervical carcinoma-in-situ treated with apparent success with curative therapy more than 1 year prior to enrollment; \n\n History of primary immunodeficiency; \n\n History within the past year of excessive alcohol intake or drug addiction. \n\n History of tobacco use of more than 10 pack years; \n\n Plans to move from the study site area during the duration of the study. \n\n Other protocol-defined inclusion/", - "brief_summary": "There is a mounting body of evidence suggesting that there is a large disparity between the development and the actual implementation of guideline-driven asthma care in primary and specialty care practices. To address this disparity, the American Academy of Allergy, Asthma & Immunology (AAAAI) developed a unique, comprehensive and easy-to-use Web-based tool for clinicians who treat asthma patients called Asthma Specialist Tool to Help Manage Asthma and Improve Quality (Asthma-IQ). This study will examine whether the use of the Asthma IQ primary care tool will improve asthma care and asthma outcomes using a randomized trial of the Asthma IQ system versus usual asthma care in the primary care setting over 1 year. At the end of 1 year, all patients will be managed using the Asthma-IQ tool for an additional year to determine if the patients managed by usual care in the first year improve when managed in conjunction with Asthma-IQ. The primary endpoint to determine if the use of the Asthma IQ tool will improve asthma patient outcomes is quarterly assessments of Asthma Control Test (ACT) scores via automated / electronic patient survey. The secondary endpoint is asthma exacerbations and there are a number of exploratory endpoints to further define the clinical utility of the primary care version of Asthma-IQ. This study will involve recruiting approximately 20 family medicine offices with approximately 20 patients each, to conduct this randomized, multiple time point intervention trial. The necessary total recruited patient sample size is 200 per group. The results of this study will help determine the utility of Web-based tools to help manage chronic diseases such as asthma.", - "NCTID": "NCT01296477" - } - ], - "1": [ - { - "brief_title": "Dose of Corticosteroids in COPD", - "phase": "Phase 4", - "drugs": "['Low Dose Corticosteroids', 'High Dose Corticosteroids']", - "drugs_list": [ - "Low Dose Corticosteroids", - "High Dose Corticosteroids" - ], - "diseases": "['COPD']", - "diseases_list": [ - "COPD" - ], - "enrollment": "125.0", - "inclusion_criteria": "inclusion criteria: \n\n i. Patients with a diagnosis of COPD, emphysema, or chronic bronchitis ii. Age \u2265 40 years-old iii. Smoking history \u2265 10 pack-years iv. Presentation to the emergency room with increased dyspnea, increased sputum, or increased cough v. Admission to the hospital \n\n ", - "exclusion_criteria": ": \n\n i. Alternative diagnosis for cause of dyspnea, increased sputum or cough ii. Patients who requires intubation at time of recruitment iii. Patients who are unable to give consent iv. Patients who are pregnant or could be pregnant or are currently breast-feeding v. Women of child-bearing age who cannot use methods of contraception as described in the consent, including condoms, female condoms, cervical caps, diaphragms, and intra uterine devices. \n\n vi. Patients who were previously entered into the trial and are re-admitted to the hospital with a new COPD exacerbation.", - "brief_summary": "COPD (chronic obstructive pulmonary disease) is a long-lasting lung disease usually caused by long-term smoking. COPD can get worse, making people sick enough to need hospitalization. Corticosteroids are very effective and are almost always used, but nobody knows the right dose. High doses may work better but could cause more side effects than low doses. Typical treatment lengths last at least one week. This study will be comparing two common regimens: either 40mg of corticosteroids daily (low dose), or 80mg of corticosteroids daily (high dose). It is unknown which regimen works better..", - "NCTID": "NCT01742338" - }, - { - "brief_title": "Genetic Mechanisms of Chronic Obstructive Pulmonary Disease (COPD)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Lung Disease']", - "diseases_list": [ - "Chronic Obstructive Lung Disease" - ], - "enrollment": "", - "inclusion_criteria": "Age greater than or equal to 40 years \n\n Cigarette smoking greater than or equal to 30 pack years \n\n Obstructive Spirometry \n\n First degree relative with smoking history willing to participate", - "exclusion_criteria": "", - "brief_summary": "The purpose of this study is to determine whether genetic factors contribute to an individuals risk of developing obstructive lung disease from smoking cigarettes.", - "NCTID": "NCT00018408" - }, - { - "brief_title": "Systemic Consequences and Comorbidities in Mild/Moderate Chronic Obstructive Pulmonary Disease (COPD), Time for Action!", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n age 40-80 years old \n\n cases: spirometry (post-bronchodilator) based diagnosis of COPD (GOLD criteria) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment. \n\n smoking controls: no COPD (spirometry based) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment. \n\n non-smoking controls: no COPD (spirometry based) + < 1 pack year \n\n ", - "exclusion_criteria": ": \n\n Respiratory disorder other than COPD \n\n \u03b11-antitrypsin deficiency \n\n Known history of significant inflammatory disease other than COPD \n\n COPD exacerbation within 4 weeks prior to study \n\n Lung surgery \n\n Recent diagnosis of cancer \n\n Therapy with oral corticosteroids in the last 6 weeks \n\n Significant cardiovascular comorbidity \n\n Significant orthopedic/musculoskeletal problems", - "brief_summary": "The aim of this prospective case-control study is to investigate the prevalence, severity and incidence of systemic consequences in newly detected patients with mild and moderate Chronic obstructive pulmonary disease (COPD). Special attention will be paid to skeletal muscle dysfunction and physical inactivity as these factors are, together with smoking, potentially modifiable.", - "NCTID": "NCT01314807" - }, - { - "brief_title": "Substudy : Patients With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease", - "phase": "", - "drugs": "['No specific intervention for this study']", - "drugs_list": [ - "No specific intervention for this study" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n male and female \n\n COPD with an FEV1 of under 60% of predicted \n\n non-smoker \n\n between 50 and 75 years old \n\n experiencing an acute exacerbation of COPD (24-48 hours, before treatment) \n\n ", - "exclusion_criteria": ": \n\n all inflammatory disease (HIV, cancer, renal and cardiac deficiency) \n\n hormonal dysregulation \n\n inferior limb pathology \n\n neuromuscular pathology \n\n history of tobacco or alcool abuse \n\n oxygen dependent", - "brief_summary": "Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Its prevalence is in progression and COPD is expected to become the fourth leading cause of death by 2030. COPD is characterized by periods of stability interspersed with acute infectious/inflammatory flare-ups, also called acute exacerbations, during which patients deteriorate, sometimes to the point of requiring immediate medical assistance. Although most patients eventually recover, repeated episodes of exacerbations may accelerate COPD progression. Exacerbations may further compromise the integrity of limb muscles by promoting further loss in muscle mass and strength.~The overall objective of this substudy is to elucidate how an acute COPD exacerbation may affect limb muscles.", - "NCTID": "NCT02282436" - }, - { - "brief_title": "Predictive Questionnaires for Risk of Acute COPD (Chronic Obstructive Pulmonary Disease) Exacerbations", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['COPD']", - "diseases_list": [ - "COPD" - ], - "enrollment": "634.0", - "inclusion_criteria": "inclusion criteria: \n\n Signed informed consent \n\n Age \u2265 40 years \n\n Patients fulfilling criteria for COPD according to the Global initiative for chronic obstructive pulmonary disease (GOLD) stage I or higher \n\n Smokers or ex-smokers of at least 10 pack-years \n\n Patients suffering an AECOPD either: \n\n Admitted to hospital due to AECOPD (severe exacerbation) or \n\n Confirmed AECOPD at GP (general practitioner) setting (moderate exacerbation) Definition AECOPD: Increase in respiratory symptoms requiring treatment with oral corticosteroids, antibiotics or both. \n\n ", - "exclusion_criteria": ": \n\n Patients who have never smoked \n\n Patients with active long-term respiratory disease (e.g. bronchial asthma, cystic fibrosis, severe bronchiectasis, malignancy, restrictive lung diseases etc.) \n\n Exacerbation of COPD due to other causes such as pneumothorax and acute decompensated congestive heart failure \n\n Difficulties in communication (cognitive deterioration, sensorial disability, language barriers) \n\n Severe disease with poor vital prognosis (life length expectancy less than one year)", - "brief_summary": "COPD patients frequently suffer intermittent exacerbations of their disease characterised by acute deterioration of symptoms. Acute exacerbations of COPD (AECOPD) are associated with significant impairment of health status, use of health care resources, poor prognosis and increased mortality. The development of simple and practical predictive tools would help to identify COPD patients at greater risk of suffering exacerbations, which is important since those patients would need more intense and early treatment.~This one-year prospective cohort non-drug study will evaluate several COPD-specific questionnaires as predictive tools and the presence of cardiovascular comorbidities as risk factors, for the composite events in study cohorts. The trial duration consists of a screening period (4-6 weeks) and a follow-up period (12 months), 4 visits in total along the study.", - "NCTID": "NCT01248507" - }, - { - "brief_title": "Granzymes and Perforin at the Onset of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "30.0", - "inclusion_criteria": "COPD patients \n\n inclusion criteria: \n\n All COPD patients who seek medical assistance at the clinic during the study period will be asked about COPD exacerbation related symptoms-medical history and then they will be included in the study if they satisfied all the following criteria: \n\n COPD diagnosis according to the GOLD Consensus Statement \n\n initiation of symptoms diagnostic for COPD exacerbation in the past 72 hours \n\n abstention from any new therapeutic intervention \n\n absence of any signs suggestive of severe exacerbation requiring hospitalization \n\n Control subjects \n\n inclusion criteria: \n\n Subjects who seek medical assistance at respiratory clinic for symptoms suggesting acute bronchitis (dyspnea, sputum production, purulence, wheeze, cough) \n\n medical history free of COPD, Asthma, pneumonia, other chronic respiratory disease or congestive cardiac failure, \n\n initiation of symptoms in the past 72 hours, \n\n abstention from any new therapeutic intervention, and \n\n absence of any signs suggestive of clinical condition requiring hospitalization. \n\n ", - "exclusion_criteria": ": \n\n Patients with Asthma or other respiratory disease will be excluded from this study", - "brief_summary": "COPD exacerbations are characterized by an excessive accumulation and activation of inflammatory cells in the airways. It is not known whether this phenomenon represents a risk for for lung damage via the release in the extracellular environment of potent cytolitic cellular granular contents such as granzymes and perforin.~The investigators assess the intracellular expression of granzymes and perforin in neutrophils and large granular lymphocytes (LGL) at the onset of exacerbations compared to stable disease.~The investigators hypothesize that a greater release of intracellular perforin and granzymes from neutrophils and LGL into the extracellular environment occur at exacerbations compared to stable condition and that these changes are more pronounced in COPD patients than in subjects without COPD who undergo respiratory infection.", - "NCTID": "NCT00883701" - }, - { - "brief_title": "Antibiotic/COPD in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) Requiring Mechanical Ventilation", - "phase": "Phase 3", - "drugs": "['ciprofloxacin', 'trimethoprim-sulfamethoxazole']", - "drugs_list": [ - "ciprofloxacin", - "trimethoprim-sulfamethoxazole" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease', 'Sepsis', 'Antibiotics']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease", - "Sepsis", - "Antibiotics" - ], - "enrollment": "170.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients having a COPD (according to the definition of the American Thoracic Society) and having an acute exacerbation leading to an acute respiratory failure requiring the admission to ICU and mechanical ventilation. \n\n The acute exacerbation of COPD is defined by increase in the frequency of cough, the volume and the purulence of expectoration and increase of baseline dyspnea. To be included, patients must have respiratory rate >30 cycles/min and one of the following blood gas criteria (with blood gases performed right before the initiation of mechanical ventilation): PaC02 > 6kPa and arterial pH <7.30. \n\n ", - "exclusion_criteria": ": \n\n Pneumonia documented with chest radiography \n\n Antibiotic treatment in the ten previous days of ICU admission \n\n Former inclusion in the study \n\n History of allergy to the quinolones and/or to trimethoprim sulfamethoxazole \n\n Pregnancy or breast feeding \n\n Severe chronic disease: heart, liver, kidney. \n\n Known immunodeficiency (malignant hemopathy, AIDS...) \n\n Digestive disease which could affect the absorption of the drugs \n\n Concomitant infection which requires systemic antibiotic treatment", - "brief_summary": "Although the use of antibiotics in the treatment of acute exacerbation of chronic obstructive pulmonary disease (COPD) is largely accepted, controversy remains regarding whether the choice of antibiotic has any impact on outcome. Our aim was to compare the effects of the combination of trimethoprim and sulfamethoxazole and ciprofloxacin in patients treated for severe COPD exacerbation requiring mechanical ventilation.", - "NCTID": "NCT00791505" - }, - { - "brief_title": "Endothelial Dysfunction in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Pulmonary Disease (COPD)', 'Inflammatory Disease', 'Endothelial Dysfunction']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease (COPD)", - "Inflammatory Disease", - "Endothelial Dysfunction" - ], - "enrollment": "29.0", - "inclusion_criteria": "inclusion criteria: \n\n presence of COPD according to standard criteria \n\n acute exacerbation of COPD according to recommended international criteria \n\n over 40 years of age \n\n history of at least 10 py \n\n ", - "exclusion_criteria": ": \n\n pneumonia \n\n history or signs of congestive heart failure, \n\n acute myocardial infarction \n\n thoracotomy incl. resection of lungtissue \n\n interstitial lung disease \n\n acute or chronic renal failure \n\n active malignancy \n\n autoimmune disease", - "brief_summary": "The purpose of the study is to determine a possible association between the clinical entity of exacerbation, markers of systemic inflammation and endothelial dysfunction in patients with COPD.", - "NCTID": "NCT01460082" - }, - { - "brief_title": "Interaction in Chronic Obstructive Pulmonary Disease Experiment", - "phase": "", - "drugs": "['Tiotropium (Spiriva) + Salbutamol (Ventolin)', 'placebo']", - "drugs_list": [ - "Tiotropium (Spiriva) + Salbutamol (Ventolin)", - "placebo" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease', 'Cardiovascular Disease', 'Smoking', 'Bronchodilation']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease", - "Cardiovascular Disease", - "Smoking", - "Bronchodilation" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n COPD Gold stage II-III (FEV1/FVC<0,70 and FEV1 30-80% of predicted value). \n\n Current cigarette smoking (at the time of performing the study). \n\n Willing to provide written informed consent. \n\n Refrain from smoking and bronchodilators > 8 hours (depends on treatment) before the test. \n\n Registered in one of the recruitment institutes. \n\n ", - "exclusion_criteria": ": \n\n COPD gold stage I or IV. \n\n Asthmatic component: History of asthma, present asthma by complaints, eosinophilia or reversibility \u2265 10% of predicted. \n\n Unable to communicate. \n\n Physically unable to perform any of the tests. \n\n Non-COPD respiratory disorders. \n\n Previous lung-volume reduction surgery and/or lung transplantation. \n\n Evidence of alcohol, drug or solvent abuse. \n\n Known \u03b1-1 antitrypsin deficiency.", - "brief_summary": "The final purpose of this study is to determine whether bronchodilation and cigarette smoking in Chronic Obstructive Pulmonary Disease (COPD) patients interact, resulting in an increase of cardiovascular disease. The aim of this part of the study is to demonstrate the basic mechanism: Does increased respiratory function after administration of a bronchodilator in patients with COPD lead to elevated pulmonary retention of the harmful compounds in inhaled cigarette smoke and to short-term biological effects associated with cardiovascular disease?", - "NCTID": "NCT00981851" - }, - { - "brief_title": "Causes, Characteristics and Mechanisms of Infective Exacerbations in Subjects With Asthma and Chronic Obstructive Pulmonary Disease (COPD)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Asthma', 'COPD']", - "diseases_list": [ - "Asthma", - "COPD" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female (medically or surgically postmenopausal or practicing an accepted form of barrier or hormonal contraception) subjects between 18 - 80 years. \n\n Any severity of exacerbation of obstructive airway disease attending the outpatient clinic. \n\n History of at least two exacerbations in the past 12 months prior to recruitment that required a course of prednisone or antibiotic or long acting bronchodilator or inhaled corticosteroid, in addition to the daily maintenance therapy. \n\n Signed written informed consent to participate in the protocol and ability to return to the outpatient clinic for repeated clinic visits. \n\n ", - "exclusion_criteria": ": \n\n If the exacerbation is severe enough to warrant hospitalization. \n\n Active malignancy. \n\n Significant gastrointestinal, hematological, cardiovascular or cerebrovascular disorder that would affect compliance with follow up visits. \n\n Recent (within the past 2 months) or planned (within the study period) lung surgery. \n\n Psychosis, alcoholism, active substance abuse or any personality disorder that would make compliance with the follow up visits problematic. \n\n Pregnant or nursing females, as this could affect the compliance during the trial. \n\n Any other medical or social condition, which in the opinion of the investigator could confound the interpretation of the data derived from this study.", - "brief_summary": "Diseases of the airways (bronchi) of the lungs include asthma and chronic obstructive pulmonary disease (COPD), which are leading causes of reduced quality of life, loss of work, hospital admissions and deaths and result in a major economic burden to the patient and society. Worsening (exacerbation) of these conditions is common and is frequently due to viral or bacterial infection, which causes inflammation in the bronchi, i.e. bronchitis. Ways to objectively measure the inflammation are needed to improve diagnosis, cause and severity and to guide treatment. The investigators also need to understand changes in the body's defense (immune) mechanisms that make some patients have more frequent infective bronchitis.~At present, sputum cell counts are able to identify different types of bronchitis, their severity and may be able to differentiate viral from bacterial infection. Other measurements in sputum, exhaled breath, blood and urine are also available to measure this inflammation. Measurement of immune cells in the blood gives us an idea about the working capacity of the immune system of the body.~The investigators plan to study patients with asthma or COPD at the time of worsening of their condition to identify,~To what extent viral or bacterial bronchitis can be diagnosed from tests of inflammation?~How clearing of infection relates to clearing of inflammation?~What are the changes in the body's defense mechanisms that make a patient more prone to frequent infective bronchitis?~How do the measurements in sputum, exhaled breath, blood and urine relate to viral and bacterial bronchitis?~What are the differences in the measurements in sputum, exhaled breath, blood and urine in asthma and COPD?", - "NCTID": "NCT00512954" - }, - { - "brief_title": "The Effect on Small Airways of Addition of Theophylline as Inducer of Histone Deacilase Activity for Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Treated With Inhaled Steroids and Long Acting Beta Agonists", - "phase": "", - "drugs": "['Theophylline', 'Placebo']", - "drugs_list": [ - "Theophylline", - "Placebo" - ], - "diseases": "['COPD']", - "diseases_list": [ - "COPD" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n stable stage II and III (GOLD) COPD, diagnosed 2 years ago and up \n\n ", - "exclusion_criteria": ": \n\n Heart failure Malignancy Immune suppressed", - "brief_summary": "Chronic obstructive pulmonary disease (COPD) is a chronic progressive respiratory disorder causing disability with an increasing burden to the patient, his family and to the health services. Treatment of COPD patients depends on the stage of the disease. COPD responds poorly to corticosteroids, in spite of inflammation is a major component in its pathogenesis. A major barrier to therapy of COPD is resistance to the anti-inflammatory effects of corticosteroids. The molecular mechanisms for this corticosteroid resistance are now being elucidated, particularly as the molecular basis for the anti-inflammatory effects of corticosteroids is better understood (12). An important mechanism of corticosteroid resistance in COPD, which is also linked to amplification of the inflammatory process, is a reduction in the critical nuclear enzyme histone deacetylase (HDAC)2 . Since the major changes are at the level of small airways. We will examine the effect of addition of theophylline product to stable COPD patients treated with combined inhaler of inhaled corticosteroids.", - "NCTID": "NCT00893009" - }, - { - "brief_title": "Smoking Cessation in Patients With COPD (SMOCC) in General Practice", - "phase": "Phase 4", - "drugs": "['Counseling and Nicotine replacement (CN)', 'Counseling, Nicotine replacement and Bupropion (CNB)']", - "drugs_list": [ - "Counseling and Nicotine replacement (CN)", - "Counseling", - "Nicotine replacement and Bupropion (CNB)" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease (COPD)']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease (COPD)" - ], - "enrollment": "667.0", - "inclusion_criteria": "inclusion criteria: \n\n A software program using Anatomical Therapeutical Chemical (ATC) prescription codes and International Classification of Primary Care (ICPC) diagnosis codes selected potential patients with COPD. Criteria: age >35 years and a diagnosis recorded as COPD or as ICPC code R95/96, or a prescription of at least three times of bronchodilators (ATC code R03a/bc) and/or prescription of at least two times of inhaled anti-inflammatory medication in the past year (ATC code R03). General practitioners (GPs) had to confirm the diagnosis of the selection. Patients were eligible to participate if they met the following criteria: \n\n Current smoking \n\n Suffering from COPD according to the GP's diagnosis \n\n In command of the Dutch language. \n\n ", - "exclusion_criteria": ": \n\n Too ill \n\n Under control of a chest physician \n\n Serious physical or psychological comorbidity", - "brief_summary": "Background: Smoking cessation is the key element in the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). The role of the general practice in assisting these patients with successful quitting smoking was suboptimal. Therefore we evaluated the effectiveness of two smoking cessation programs (counseling and nicotine replacement) for smokers with COPD in routine general practice, one with (CNB) and one without (CN) the combination with bupropion-SR, compared to usual care (UC) and explored the role of COPD symptoms in successful smoking cessation.~Method: RCT with 667 patients with COPD, 68 general practices were randomly allocated. The usual care group (UC) consisted of 148 patients (22 practices), the first intervention group (counseling plus nicotine replacement (CN) of 243 patients (21 practices) and the second intervention group of 276 patients (25 practices. Main outcome measure was (biochemically verified) point prevalence.", - "NCTID": "NCT00628225" - }, - { - "brief_title": "The HERO-study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121)", - "phase": "Phase 3", - "drugs": "['Roflumilast']", - "drugs_list": [ - "Roflumilast" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease, COPD']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease", - "COPD" - ], - "enrollment": "550.0", - "inclusion_criteria": "Main inclusion criteria: \n\n Written informed consent \n\n Patients with a history of chronic obstructive pulmonary disease for at least 12 months as defined by the GOLD (Global Initiative on Obstructive Lung Diseases) criteria (2003) \n\n Age \u2265 40 years \n\n FEV1/FVC ratio (post-bronchodilator) \u2264 70% \n\n FEV1 (post-bronchodilator) \u2264 65% of predicted \n\n FRC (post-bronchodilator) \u2264 120% of predicted \n\n Clinically stable COPD within 4 weeks prior to baseline visit (B0). \n\n Availability of a chest x-ray dated a maximum of 6 months prior to study baseline visit (B0) or a willingness to have a chest x-ray performed at visit (B0). \n\n Main ", - "exclusion_criteria": ": \n\n COPD exacerbation indicated by a treatment with systemic glucocorticosteroids not stopped at least 4 weeks prior to the baseline visit (B0) \n\n Non smoker, current smoker or ex-smoker (smoking cessation at least one year ago) with a smoking history of < 10 pack years \n\n Suffering from any concomitant disease that might interfere with study procedures or evaluation \n\n Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit (B0) \n\n Diagnosis of asthma and/or other relevant lung disease (e.g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease [e.g. fibrosis, silicosis, sarcoidosis], and active tuberculosis) \n\n Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 2 months preceding the baseline visit (B0). \n\n Known alpha-1-antitrypsin deficiency \n\n Need for long term oxygen therapy defined as \u2265 15 hours/day \n\n Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator) \n\n Known infection with HIV, active hepatitis and/or liver insufficiency \n\n Diagnosis or history of cancer (other than basal cell carcinoma) or recurrence within 5 years prior to study start \n\n Clinically significant cardiopulmonary abnormalities (diagnosed clinically or by x-ray/ECG) that are not related to COPD and that require further evaluation \n\n Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial \n\n The female patient is of childbearing potential and is not using and is not willing to continue to use a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless she is surgically sterilized/hysterectomized or post-menopausal > 1 year or any other criteria considered sufficiently reliable by the investigator in individual cases \n\n Participation in another study (use of investigational product) within 30 days preceding the baseline visit (B0) or re-entry of patients already enrolled in this trial \n\n Suspected inability or unwillingness to comply with study procedures \n\n Alcohol or drug abuse \n\n Inability to follow study procedures due to, for example, language problems or psychological disorders \n\n Use of prohibited drugs \n\n Suspected hypersensitivity to the study medication and/or contraindication to any ingredients of the study medication (roflumilast) or rescue medication", - "brief_summary": "The purpose of this trial is to study the effects of roflumilast on lung function parameters indicative of hyperinflation in patients with COPD.", - "NCTID": "NCT00108823" - }, - { - "brief_title": "Reduction of Corticosteroid Use in Outpatient Treatment of Exacerbated COPD", - "phase": "", - "drugs": "['Placebo', 'Prednisone']", - "drugs_list": [ - "Placebo", - "Prednisone" - ], - "diseases": "['Pulmonary Disease, Chronic Obstructive', 'Adverse Effect of Glucocorticoids and Synthetic Analogues', 'Disease Exacerbation']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive", - "Adverse Effect of Glucocorticoids and Synthetic Analogues", - "Disease Exacerbation" - ], - "enrollment": "470.0", - "inclusion_criteria": "inclusion criteria: \n\n Informed Consent as documented by signature \n\n Age \u226540 years \n\n History of \u226510 pack-years of smoking (past or present smokers) \n\n Airway obstruction, defined as FEV1/FVC\u226470% \n\n Current acute exacerbation of COPD by clinical criteria, defined by the presence of at least two of the following: \n\n Change of baseline dyspnea \n\n Change of cough \n\n Change of sputum quantity or purulence \n\n ", - "exclusion_criteria": ": \n\n Diagnosis of asthma \n\n Initial necessity of hospitalization \n\n Women who are pregnant or breast feeding \n\n Premenopausal women with insufficient contraception and anamnestic risk for pregnancy \n\n Severe coexisting disease with life expectancy <6 months \n\n Diagnosis of tuberculosis \n\n Known severe immunosuppression or immunosuppression after solid organ or stem cell transplantation \n\n Inability to follow study procedures, e.g. due to language problems, psychological disorders, dementia, etc. of the participant \n\n Participation in another study involving an investigational drug \n\n Previous enrolment into the current study", - "brief_summary": "Background~Chronic obstructive pulmonary disease (COPD) is a major public health issue with no curative treatment. In Switzerland estimated 5-7% of the total population are suffering from this chronic disease. According to current guidelines corticosteroids are part of treatment of acute exacerbations in COPD patients. Several studies suggest that corticosteroids accelerate the recovery of forced expiratory volume in 1 second (FEV1), decrease duration of hospitalization, reduce treatment failure rate and improve clinical outcome. The additional therapeutic benefit on FEV1-recovery tough seems only to last for three to five days. The investigators recently published a hospital-based study showing that in patients presenting to emergency departments with acute exacerbation of COPD, a short five day treatment with systemic steroids was not inferior to a conventional 14 day treatment with regard to re-exacerbation. Cumulative corticosteroid dose could be reduced in this trial. To the investigators knowledge no data is available about the minimal necessary corticosteroid dose in an outpatient treatment setting so far.~Aim~The primary aim of this study is to investigate in an outpatient setting, whether a three day treatment with orally administered systemic corticosteroids is non-inferior to a five day treatment in acute exacerbation of COPD and if total glucocorticoid exposure can be reduced by shorter therapy.~Hypothesis~The investigators postulate, that in an outpatient setting, where generally less severe exacerbations are being treated, a three day treatment duration of systemic corticosteroids should be non-inferior to a five day treatment duration with regard to treatment benefits but decrease cumulative corticosteroid exposure.~Design and Setting~This study is going to be performed as a prospective, randomized, double-blind, placebo-controlled, non-inferiority trial in an outpatient setting. Randomization will be performed as block randomization with a 1:1 allocation. The investigators are going to recruit GPs in northwestern and central Switzerland.~Methods~The investigators are going to include patients presenting to GP's with acute exacerbation of COPD. When matching the investigators eligibility criteria and written informed consent is given, patients included in the study are receiving systemic corticosteroid treatment (equivalent of 40mg prednisone daily) for either five days (conventional arm) or three days (interventional arm) followed by two days of placebo for the interventional group. Pre-randomized, identically looking, numbered blisters are given to all patients included in the study. Antibiotic treatment (Amoxicillin/Clavulanic acid, 625mg 3/d, for ten days) is given to all patients with a CRP \u226550mg/l, COPD and known diagnosis of bronchiectasis, as well as patients presenting with all three of the following symptoms: change of baseline dyspnea, change of sputum quantity and sputum purulence. Further initial treatment and steroid treatment after inclusion is determined and documented by the GP. Patients will undergo follow-up visits at day three and seven by their GP as well as follow-up phone calls executed by the study center at day 30, 90 and 180.", - "NCTID": "NCT02386735" - }, - { - "brief_title": "Acute Effect of Aclidinium on Hyperinflation and Ventilation Inhomogeneity in Severe COPD Patients", - "phase": "Phase 4", - "drugs": "['Aclidinium Bromide', 'Glycopyrronium Bromide']", - "drugs_list": [ - "Aclidinium Bromide", - "Glycopyrronium Bromide" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "37.0", - "inclusion_criteria": "inclusion criteria: \n\n Signature of informed consent \n\n COPD patients with age raging from 50 to 85 years old \n\n Patients with at least a history of COPD of one year \n\n COPD patients clinically stable in the last three months \n\n COPD subjects with Forced Expiratory Volume at one second (FEV1)<50% of predicted value \n\n COPD subjects with Residual Volume (RV) >125% predicted value \n\n FEV1/Forced Vital Capacity (FVC) <88% (males) or <89% (females) of Low Levels of Normality (LLN) \n\n COPD former or active smokers with at least a smoking history of 20 pack year \n\n ", - "exclusion_criteria": ": \n\n Acute Bronchial Exacerbation at recruitment \n\n Fertile women with age between 18 and 50 years old or with active period \n\n Pregnancy \n\n Subjects enrolled in other clinical trials or that have taken part in one of them in the month preceding the enrollment. \n\n FEV1/FVC more than 70% of predicted value in basal conditions \n\n FEV1 more than 70% of predicted value in basal conditions \n\n Known deficit of alpha 1 antitrypsin \n\n Subjects that underwent a Lung Volume Reduction Surgery (LVRS) \n\n Subjects with known positivity to Human Immunodeficiency Virus (HIV) \n\n Misuse of alcool or drugs \n\n Lack of compliance in performing respiratory tests \n\n Subjects not capable to follow the study prescriptions because of psychic disorders or language problems. \n\n Long Term Oxygen Therapy with flows > 6 litres per minute (l/min) at rest", - "brief_summary": "Chronic Obstructive Pulmonary Disease (COPD) is characterized by lung hyperinflation and flow limitation. These physiopathological modifications are secondary to loss of elastic recoil and bronchial obstruction due to emphysema.~The cornerstone of COPD treatment is represented by inhaled beta-2 agonists and anticholinergics. The molecules of the latter classes can be characterized by short lasting action (few hours), long acting action (12 hours) or ultra long acting duration of action (24 hours).~For years the only anticholinergic (or antimuscarinic) drug other than those used by aerosol, was Tiotropium Bromide. Recently two new antimuscarinic agents have been launched on the market: glycopyrronium bromide (once daily) and aclidinium (twice daily).~The Single Breath Nitrogen Test is capable of identifying the pulmonary closing volume. The part of the curve that reflects lung ventilation inhomogeneity is the slope of phase III~For COPD patients, the most important characteristic for an inhalatory drug is a prompt action in order to give a quick relief from respiratory symptoms, in particular dyspnoea.~The objective of this study is to study the acute action of glycopyrronium and aclidinium in terms of reduction of hyperinflation, pulmonary specific resistances, lung volume distribution and dyspnoea at rest in severe COPD patients.~To our knowledge no study has explored these aspects before.", - "NCTID": "NCT02181023" - }, - { - "brief_title": "Effects of Inhaled Corticosteroids in the Systemic Inflammation Induced by Exercise in Patients With COPD", - "phase": "Phase 4", - "drugs": "['Fluticasone', 'Inhaled Placebo']", - "drugs_list": [ - "Fluticasone", - "Inhaled Placebo" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "23.0", - "inclusion_criteria": "inclusion criteria: \n\n ex-smokers (> 10 packets-year) with moderate-severe COPD patients", - "exclusion_criteria": "", - "brief_summary": "Chronic obstructive pulmonary disease (COPD) is characterized by pulmonary and systemic inflammation. The effect of inhaled corticosteroids (IC) on inflammation in COPD is controversial.", - "NCTID": "NCT02209974" - }, - { - "brief_title": "CRP-guided Antibiotic Treatment in COPD Exacerbations Admitted to the Hospital", - "phase": "", - "drugs": "['CRP-guided antibiotic treatment']", - "drugs_list": [ - "CRP-guided antibiotic treatment" - ], - "diseases": "['COPD', 'Exacerbation', 'Bronchitis', 'Sputum', 'C-Reactive Protein']", - "diseases_list": [ - "COPD", - "Exacerbation", - "Bronchitis", - "Sputum", - "C-Reactive Protein" - ], - "enrollment": "220.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 40 or over. No upper age limit will be employed. \n\n Written informed consent obtained. \n\n AECOPD according to the GOLD guideline. An exacerbation of COPD is defined as an event in the natural course of the disease characterized by a change in the patient's baseline dyspnoea, cough, and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication in a patient with underlying COPD. \n\n Criteria for hospital admission according to the GOLD: marked increase in symptoms (i.e. resting dyspnoea), severe underlying COPD, onset of new physical signs (cyanosis, edema), failure to respond to initial medical management, significant co morbidities, frequent exacerbations, newly occurring arrhythmias, diagnostic uncertainty. \n\n Former of current smoker with a minimum smoking history of 10 pack years. \n\n Patients have to be capable of ingesting oral medication. \n\n Patients have to be mentally capable of participating in the study (able to complete questionnaires and perform lung function tests). \n\n Life expectancy \u2265 30 days. \n\n ", - "exclusion_criteria": ": \n\n Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception. \n\n Pretreatment with corticosteroids (cumulative dose >210 mg) for the present exacerbation. \n\n Progression or new radiographic abnormalities on the chest X-ray or CT scan compatible with pneumonia. \n\n bronchiectasis (HRCT confirmed). \n\n Cystic fibrosis. \n\n Tuberculosis. \n\n Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc., and the use of immunosuppressive drugs (>30 mg prednisolone/day maintenance dose or equivalent for more than 4 weeks). \n\n Recent or unresolved lung malignancy. \n\n Other disease likely to require antibiotic therapy, such as recurrent sinusitis or urinary tract infection. \n\n Significant gastrointestinal or other conditions that may affect study drug absorption. \n\n Class III or IV congestive heart failure or stroke. \n\n Newly diagnosed pulmonary embolism", - "brief_summary": "Rationale: Acute exacerbations are key events in chronic obstructive pulmonary disease (COPD), resulting in poorer quality of life. Causes include irritants, viruses and bacterial pathogens. These exacerbations are often treated with a combination of corticosteroids, bronchodilators and antibiotics, but the benefit of antibiotic therapy remains controversial. Several trials studying antibiotic treatment in AECOPD showed conflicting data, with several large studies failing to demonstrate superiority of antibiotic therapy over placebo. Other trials indicated that antibiotic therapy is effective in patients who have at least two of the following symptoms: increased dyspnoea, increased sputum volume and increased sputum purulence. Ever since sputum purulence has been used as a predictive marker in AECOPD, a strategy that has been integrated in the GOLD guideline for treatment of AECOPD. However, the color of sputum reported by patients is not always reliable and inspection of sputum is not always possible. Several serum biomarkers such as C-reactive protein (CRP) and procalcitonin (PCT) are now available. In a recent trial of doxycycline in addition to systemic corticosteroids for patients hospitalized with AECOPD we found that CRP might be valuable as a marker predictive of response to antibiotic treatment in AECOPD.", - "NCTID": "NCT01232140" - }, - { - "brief_title": "Microbiology & Immunology of the Chronically-inflamed Airway", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Pulmonary Disease (COPD)']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease (COPD)" - ], - "enrollment": "57.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects who the investigator believes can and will comply with the requirements of the protocol. \n\n Written informed consent obtained from the subject. \n\n Male or female subjects between, and including, 40 and 85 years of age, at the time of consent. \n\n Subjects with confirmed diagnosis of COPD (based on postbronchodilator spirometry). [GOLD, 2009] with FEV1 of >80% (mild COPD) or >50% but \u226480% (moderate COPD) of predicted normal and FEV1/FVC<0.7 \n\n Subjects have mild or moderate COPD, according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) staging [GOLD, 2009]. \n\n Subjects have a current or prior history of \u226510 pack years of cigarette smoking. Former smokers are defined as those who have stopped smoking for at least 6 months. Number of pack years = (number of cigarettes per day/20) x number of years smoked. \n\n Subjects with recent COPD exacerbations, in stable condition, and having stopped antibiotics, can be enrolled one month post exacerbation. \n\n ", - "exclusion_criteria": ": \n\n Subject also has a confirmed diagnosis of asthma (as only cause of obstructive respiratory disorder), cystic fibrosis, pneumonia risk factors (e.g., HIV, Lupus, Parkinson's, Myasthenia Gravis) or other respiratory disorders (e.g., tuberculosis, lung cancer). \n\n Subjects having undergone lung surgery \n\n Subject has a \u03b11-antitrypsin deficiency as underlying cause of COPD. \n\n Subject who experienced a moderate or severe COPD exacerbation not resolved at least 1 month prior to enrolment visit and at least 30 days following the last dose of oral corticosteroids (subjects can be enrolled when their acute AECOPD or pneumonia has resolved). \n\n Subject using any antibacterial, antiviral or respiratory investigational drug or relevant vaccine up to 30 days prior to the enrolment visit. \n\n Subject has other conditions that the principal investigator judges may interfere with the study findings, such as: \n\n Subject at risk of noncompliance, or unable to comply with the study procedures. \n\n Evidence of alcohol or drug abuse. \n\n Others, as per clinical judgement \n\n Women who are pregnant or lactating or are planning on becoming pregnant during the study **If subject has any ONE of the above exclusion they cannot be enrolled into the study**", - "brief_summary": "Chronic obstructive pulmonary disease (COPD) is the fourth most common cause of death and the only one of the common causes that is still rising. The main effects of the disease are the destruction and inflammation of lung tissue rendering breathing difficult. COPD has significant effects on the quality of life of sufferers and the disease is predicted to be the fifth most common cause of disability in the world by 2020. Patients with COPD are prone to periods of worsening disease symptoms, known as exacerbations, which are often caused by viral and bacterial infections of the lung and current vaccines appear to have little efficacy in limiting these exacerbations. The loss of lung function caused by infectious exacerbations is irreversible and patients who frequently exacerbate experience more rapid disease progression. Nontypeable Haemophilus influenzae (NTHi) is a major bacterial species that colonises the airways and causes exacerbations in COPD. With the development of more sensitive molecular techniques it has been possible to ascertain that it is the acquisition of new strains of NTHi that correlate strongly with exacerbations. However, not all patients with COPD have NTHi in their lungs and the question remains as to why some COPD patients are susceptible to such infections. This study aims to answer this question by comparing the airways of COPD patients who are colonized by NTHi and those who are not to analyse whether the levels of protective antibodies in the lungs and the function of the immune cells in the NTHi colonized airway are reduced. Moreover, we aim to correlate this reduction in immunity with areas of lung damage ascertained by high resolution computed tomography. The aim of this research is to better understand this apparent deficiency in airway immunity as this is likely to impact on vaccine efficacy in COPD.", - "NCTID": "NCT01701869" - }, - { - "brief_title": "Outcomes for Chronic Obstructive Pulmonary Disease Moderate Exacerbators Initiating Treatment", - "phase": "", - "drugs": "['Fluticasone Propionate / Salmeterol Xinafoate Combination (FSC)', 'Anticholinergics (AC)']", - "drugs_list": [ - "Fluticasone Propionate / Salmeterol Xinafoate Combination (FSC)", - "Anticholinergics (AC)" - ], - "diseases": "['Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "2849.0", - "inclusion_criteria": "inclusion criteria: \n\n minimum age 40 years at index \n\n continuously enrolled in health plan \n\n diagnosis of COPD (ICD-9 codes of 491, 492, 496) \n\n at least one moderate exacerbation event as defined previously. \n\n ", - "exclusion_criteria": " \n\n Exclusionary comorbid conditions of respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis (TB), bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary TB, or sarcoidosis \n\n Patients excluded if they did not receive treatment within the treatment assessment period following moderate exacerbation \n\n Receipt of maintenance medication in the pre-period \n\n Presence of treatment switch, discontinuation of index drug, or any COPD-related exacerbation during the treatment assessment period", - "brief_summary": "Patients with moderate COPD as defined by GOLD guidelines constitute almost 46% to 54% of all diagnosed COPD patients. Yet limited data exists on characterizing this study population in terms of drug therapy patterns and COPD-related resource use and costs. The objective of the following study was to conduct an analysis in the real-world setting to (1) identify and characterize COPD patients with moderate exacerbations and (2) evaluate the impact of initiating different maintenance therapies in this population. Maintenance therapy medications include inhaled corticosteroids (ICS), long-acting beta agonists (LABAs), combination of ICS+LABA, and anticholinergics (ACs) including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium [IPR]).", - "NCTID": "NCT01395875" - }, - { - "brief_title": "A P3 Comparator Trial in Community Acquired Bacterial Pneumonia", - "phase": "Phase 3", - "drugs": "['Dalbavancin', 'Linezolid', 'Linezolid Placebo', 'Azithromycin']", - "drugs_list": [ - "Dalbavancin", - "Linezolid", - "Linezolid Placebo", - "Azithromycin" - ], - "diseases": "['Community Acquired Pneumonia']", - "diseases_list": [ - "Community Acquired Pneumonia" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults aged 18 to 85, inclusive \n\n Has given written, informed consent \n\n Has acute illness with onset within previous 7 days \n\n Has at least 2 of the following symptoms: \n\n Difficulty breathing or shortness of breath \n\n Cough \n\n Production of purulent sputum \n\n Pleuritic chest pain \n\n Has at least 2 vital sign abnormalities: \n\n Fever (> 38\u00b0C or < 35\u00b0C) \n\n Hypotension (systolic BP < 90 mm Hg) \n\n Tachycardia (> 100 beats /min) \n\n Tachypnea (> 24 breaths /min) \n\n Has at least one other clinical or laboratory abnormalities: \n\n Hypoxemia (room air SaO2 < 90% ) \n\n Clinical evidence of pulmonary consolidation \n\n Elevated WBC count or neutropenia (> 12,000/mm3 or < 4,000/mm3) \n\n Has new lobar or multi-lobar infiltrates on chest radiograph \n\n Has CURB-65 risk category 1 to 4. Patients with CURB-65 risk category 1 will be limited to 20% of the total patient population \n\n ", - "exclusion_criteria": ": \n\n Contra-indication to the administration of any of the study treatments, such as hypersensitivity to any of the glycopeptide agents, beta-lactam agents, linezolid or macrolide antibiotics, or current or recent (within 2 weeks) use of MAO inhibitors or serotonergic antidepressants (within 5 weeks for fluoxetine) (see Section 5.5.1) \n\n Has received antibiotic therapy in the 4 days prior to screening, with the following exception: up to 25% of patients may have received a single dose of a short acting (half life < 8 hours) antibiotic \n\n Has aspiration pneumonia \n\n Has hospital acquired or ventilator associated pneumonia, or healthcare associated pneumonia, or 2 or more days in hospital in the previous 90 days \n\n Has cystic fibrosis or known or suspected Pneumocystis pneumonia or known or suspected active tuberculosis \n\n Females of child-bearing potential who are unable to take adequate contraceptive precautions, have a positive pregnancy result within 24 hours prior to study entry, are known to be pregnant, or are currently breastfeeding an infant \n\n Has primary or metastatic lung cancer \n\n Has known bronchial obstruction or a history of post-obstructive pneumonia \n\n Requires admission to ICU at baseline \n\n Has empyema requiring drainage \n\n Infection due to an organism known prior to study entry to be resistant to either treatment regimen \n\n Has known or suspected infection due solely to an atypical pathogen such as Mycoplasma sp., Chlamydia sp. or Legionella sp. or positive Legionella urinary antigen at baseline \n\n Absolute neutrophil count < 500 cells/mm3 \n\n Known or suspected human immunodeficiency virus (HIV) infected patients with a CD4 cell count < 200 cells/mm3 or with a past or current acquired immunodeficiency syndrome (AIDS)-defining condition and unknown CD4 count \n\n Patients with a recent bone marrow transplant (in post-transplant hospital stay) \n\n Patients receiving oral steroids > 40 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation \n\n Patients with a rapidly fatal illness, who are not expected to survive for 3 months \n\n Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study \n\n Has participated in another trial of an investigational pharmaceutical product in the 30 days prior to enrollment \n\n Prior participation in this trial.", - "brief_summary": "This study will be a double-blind, randomized, multicenter trial to assess the safety and efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12 hours for 10-14 days plus a single 500 mg IV dose of azithromycin for the treatment of Community Acquired Bacterial Pneumonia.", - "NCTID": "NCT02269644" - }, - { - "brief_title": "Cough Responses to Tussive Agents in Health and Disease", - "phase": "", - "drugs": "['Cough Challenge Tests', 'ambulatory cough recording', 'Cough questionnaires']", - "drugs_list": [ - "Cough Challenge Tests", - "ambulatory cough recording", - "Cough questionnaires" - ], - "diseases": "['Asthma', 'Chronic Obstructive Airway Disease', 'Chronic Cough']", - "diseases_list": [ - "Asthma", - "Chronic Obstructive Airway Disease", - "Chronic Cough" - ], - "enrollment": "102.0", - "inclusion_criteria": "inclusion criteria: \n\n General \n\n Adult subjects aged 18 years and over \n\n Meet criteria for subject groups as outlined below \n\n (1) Healthy volunteers \n\n Non-smokers \n\n No history of respiratory disease \n\n (2) Healthy smokers \n\n Current smokers with smoking history of \u226510 pack years \n\n Spirometry within normal limits i.e. FEV1>80% predicted and FEV1/FVC ratio >75% predicted \n\n (3) Asthma \n\n Physician diagnosis of asthma \n\n Airways hyperresponsiveness to methacholine; PC20<16mg/ml (within last 2 years) \n\n Non-smokers or ex-smoker with smoking history of \u226410 pack years \n\n (4) COPD \n\n Physician diagnosis of COPD \n\n Ex-smokers with smoking history of \u226520 pack years \n\n Spirometry demonstrating airflow obstruction i.e. FEV1/FVC ratio <70% \n\n (5) Chronic Cough \n\n History of a dry cough for >8 weeks \n\n Normal CXR \n\n Non-smokers or ex-smoker with smoking history of \u226410 pack years \n\n ", - "exclusion_criteria": ": \n\n 1) Symptoms of upper respiratory tract infection within the last 6 weeks 2) Participation in another clinical trial of an investigational drug within the last 4 weeks 3) Use of medication likely to alter cough reflex sensitivity i.e. ACE inhibitors, codeine phosphate, morphine sulphate, 4) Patients with severe respiratory disease i.e. FEV1 < 1 litre, 5) Significant medical co-morbidities likely to affect ability to participate in the trial or affect cough reflex sensitivity e.g. diabetes, stroke, Parkinson's disease, multiple sclerosis etc.", - "brief_summary": "The sensitivity of a persons cough reflex can be measured by getting them to breath in (inhale) irritant chemicals. The purpose of this clinical research study is to test the sensitivity of the cough reflex to a variety of chemicals that can be inhaled to see if coughing responses are different between healthy people and people with respiratory problems that make them cough.", - "NCTID": "NCT01297790" - }, - { - "brief_title": "Chest Wall Oscillation for Asthma and COPD Exacerbations Trial (COAT)", - "phase": "", - "drugs": "['High Frequency Chest Wall Oscillator']", - "drugs_list": [ - "High Frequency Chest Wall Oscillator" - ], - "diseases": "['Asthma', 'Chronic Obstructive Pulmonary Disease (COPD)', 'Undifferentiated Asthma/COPD']", - "diseases_list": [ - "Asthma", - "Chronic Obstructive Pulmonary Disease (COPD)", - "Undifferentiated Asthma/COPD" - ], - "enrollment": "52.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 years and older \n\n Admission to the inpatient medical service \n\n Physician-diagnosed asthma or asthma/COPD or COPD exacerbation. \n\n Evidence of airflow obstruction on spirometry \n\n ", - "exclusion_criteria": ": \n\n More than 24 hours since admission to the inpatient medical service \n\n Admission to an intensive care unit \n\n Hospital discharge planned within the next 24 hours \n\n Other chronic respiratory disease (e.g., sarcoidosis, idiopathic pulmonary fibrosis) \n\n Chest wall abnormalities (e.g., severe kyphoscoliosis) that precludes using the vest \n\n Chest wall or abdominal trauma/surgery in the past 6 weeks that precludes using the vest \n\n Physician declines to provide consent \n\n Patient unable (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent \n\n Previous participant in this study \n\n Corticosteroid therapy (prednisone >0 mg/d equivalent) for >1 week prior to admission", - "brief_summary": "The objective of this study was to evaluate the use of high frequency chest wall oscillation (HFCWO) early in the treatment of adults hospitalized for acute asthma or chronic obstructive pulmonary disease (COPD).", - "NCTID": "NCT00181285" - }, - { - "brief_title": "Study to Demonstrate That Antibiotics Are Not Needed in Moderate Acute Exacerbations of COPD", - "phase": "Phase 4", - "drugs": "['Sultamicillin', 'Placebo']", - "drugs_list": [ - "Sultamicillin", - "Placebo" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease (COPD)']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease (COPD)" - ], - "enrollment": "295.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults, either sex, older or equal than 40 years of age \n\n For female patients, the following conditions are to be met: \n\n has been postmenopausal for at least 1 year, or \n\n is surgically incapable of bearing children, or \n\n is of childbearing potential, and the following conditions are met: \n\n has a negative pregnancy test (urine- or serum-based) immediately before study entry (i.e., before the start of treatment or any other study procedure that could potentially harm the fetus), and one or more of following criteria \n\n must agree to abstinence or use an accepted method of contraception. The subject must agree to continue with the same method throughout the study. \n\n having only female sexual partners \n\n sexual relationship with sterile male partners only \n\n Patients diagnosed with COPD stages I-IV as defined by the Global initiative for chronic Obstructive Lung disease (GOLD). \n\n and \n\n Doctor's diagnosis of acute (onset < 7 days) moderate exacerbation of COPD defined by a sustained worsening of the patient's condition (including at least 2 of the following symptoms: increased dyspnea, increased sputum production, sputum purulence and increased cough), from the stable state and beyond normal day-to-day variations, necessitating a change in regular medication in patient with underlying COPD, needing additional medical assistance. \n\n Absence of community acquired pneumonia or lower respiratory tract infection with a clear indication for antibiotic treatment as determined by Procalcitonin level < 0.25 ng/mL and/or absence of pulmonary infiltrates on routine chest x-ray. \n\n Smoking history of at least 10 Pack Years or more. \n\n Patients must be able to complete diaries and quality of life questionnaires. \n\n Patients must sign and date an informed consent prior to any study procedures. \n\n ", - "exclusion_criteria": ": \n\n Severe exacerbation: defined by need for ventilatory support (indicated by severe dyspnea with failure to respond to emergency treatment and/or persistent hypoxemia (PaO2 <50 mm Hg despite O2 administration and / or respiratory acidosis (pH <7.35 and PaCO2> 45mmHg)) or mental confusion or circulatory insufficiency (need of vasopressors) \n\n Fever (>38.5\u00b0C) \n\n Known impaired hepatic or renal function \n\n Active or suspected tuberculosis infection of the respiratory tract \n\n Acute exacerbation of asthma \n\n Suspected or known hypersensitivity to, or suspected serious adverse reaction to sultamicillin; suspected or known hypersensitivity to penicillins or cephalosporins \n\n Immunosuppression or Immunosuppressive therapy (cytostatic chemotherapy within last 28 days or neutropenia (neutrophils < 1000/\u00b5)l; systemic corticosteroids (\u226520 mg prednisolon equivalent/day > 14 days; HIV-infection; immunosuppression after organ- or bone marrow transplant)- Patients with metastatic or hematological malignancy, splenectomized patients or patients with known hyposplenia or asplenia \n\n Oral/parenteral antibiotic use within 30 days prior to randomization (a singular administration of antibiotics prior to randomization is allowed) \n\n In-patient treatment within the last 30 days \n\n An antibiotic is clearly indicated for treatment of a known infection \n\n Known MRSA (methicillin-resistant Staphylococcus aureus) colonization or infection \n\n Patients with known bronchiectasis \n\n Patients with known bacterial airway colonization (>3 positive sputum cultures in the previous year) \n\n Progressively fatal disease, or life expectancy \u22646 months \n\n Mononucleosis \n\n Lymphatic leukemia \n\n Severe gastro-intestinal disorders with vomiting and diarrhea \n\n Women who are breast feeding \n\n Patients who have received treatment with any other investigational drug within 1 month prior to study entry, or have such treatment planned for the study period during treatment and follow up phase. \n\n Patients with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study. \n\n Patients unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow up visits, and unlikelihood of completing the study.", - "brief_summary": "The ultimate goal is to reduce unnecessary antibiotic prescriptions which drive the development of antibiotic resistance in the community. The primary objective of ABACOPD is to demonstrate in a sufficiently sized clinical study that there is no relevant increase in the failure-rate for patients with acute moderate exacerbations of COPD (AE-COPD) treated with placebo instead of antibiotic treatment both on top of standard of care. A patient is classified as treatment failure if additional antibiotic therapy is required during treatment period or until the test of cure visit (TOC at day 30, primary endpoint).", - "NCTID": "NCT01892488" - }, - { - "brief_title": "Macrolide Maintenance Therapy in Chronic Obstructive Pulmonary Disease", - "phase": "", - "drugs": "['Azithromycin', 'Placebo']", - "drugs_list": [ - "Azithromycin", - "Placebo" - ], - "diseases": "['COPD']", - "diseases_list": [ - "COPD" - ], - "enrollment": "92.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of COPD according to GOLD criteria (FEV1/FVC<70%), classification into GOLD I (FEV1 70-100% predicted), GOLD II (FEV1 50-70% predicted), GOLD III (FEV1 30- 50% predicted) or GOLD IV (FEV1 \u2264 30% predicted) \n\n Age \u2265 18 years \n\n Three or more exacerbations of COPD in one year for which a course of prednisone and/or antibiotic therapy was started \n\n Clinically stable during 1 month. Patients have to be free of COPD exacerbation or respiratory tract infection within a month prior to involvement in the study and they should not have received a high dose of systemic glucocorticoids or antibiotics in this period \n\n Informed consent \n\n ", - "exclusion_criteria": ": \n\n Use of antibiotics or high dose of systemic steroids within a month prior to involvement in the study. \n\n Addition of inhalation steroids to the patient's therapy regimen, shortly before entering the study. \n\n Pregnant or lactating women. \n\n Allergy to macrolides. \n\n Liver disease (alanine transaminase and/or aspartate transaminase levels 2 or more times the upper limit of normal). \n\n Asthma, defined as episodic symptoms of airflow obstruction which is reversible with bronchodilators, assessed with lung function testing. \n\n Presence of a malignancy which is clinically active. \n\n Bronchiectasis. \n\n Malignancy of any kind for which the subject is under treatment or is being monitored as part of follow up after treatment. \n\n Heart failure. \n\n Use of drugs which can adversely interact with macrolides and for which therapeutic monitoring cannot be undertaken.", - "brief_summary": "To assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the preceding year of inclusion can decrease the exacerbation rate in the year of treatment.", - "NCTID": "NCT00985244" - }, - { - "brief_title": "Low-dose CT for Diagnosis of Pneumonia in COPD Exacerbations and Comparison of the Inflammatory Profile.", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['COPD Exacerbation']", - "diseases_list": [ - "COPD Exacerbation" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria \n\n clinical and spirometric diagnosis of COPD. \n\n for study group: clinical symptoms of exacerbation and infection of low airway. \n\n Signed informed consent. \n\n ", - "exclusion_criteria": " \n\n No acceptance of informed consent. \n\n The STUDY GROUP: treatment with antibiotic more tan 2 days before consultation. \n\n Another entity known pulmonology other than COPD (non-obstructive disorders, bronchiectasis, interstitial lung disease patients, severe pulmonary hypertension, hypoventilation). \n\n Chronic treatment with oral corticosteroids or immunosuppressive drug. \n\n severe organ comorbidity such as cancer in advanced or terminal phase, pulmonary tuberculosis with important involvement, severe pneumoconiosis. \n\n Severe alteration of nutritional status. \n\n Heart disease evolved. \n\n Limitation for understanding the study (including psychiatric disorder, language problem, social or cultural differences, etc.).", - "brief_summary": "* Hypothesis: There is an underdiagnosis of pneumonia in COPD (Chronic Obstructive Pulmonary Disease) exacerbations which could be demonstrated by performing low-dose chest CT. Differences in the inflammatory profile in sputum and blood in patients with and without pneumonia can be seen.~* Objective: To assess the degree of underdiagnosis of pneumonia in COPD exacerbations, using chest low-dose CT and to compare clinical and inflammatory differences in blood and sputum between patients with and without pneumonia.~*Material and Methods: Prospective observational study including 75 patients with the diagnosis of COPD at the time of an exacerbation and with criteria for a respiratory tract infection. At the time of inclusion clinical features, blood and sputum analysis, chest X-ray and chest low-dose CT are performed. The investigators divide the patients into two groups according to the existence of pneumonia and the inflammatory pattern in blood (inflammatory markers) and sputum (cell populations and inflammatory markers) is compared between the two branches.", - "NCTID": "NCT02264483" - }, - { - "brief_title": "Predictive Ability of the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) for Acute Exacerbations (PACE) in Patients With COPD", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "70.0", - "inclusion_criteria": "inclusion criteria: \n\n Type of subject: Outpatients \n\n Informed consent: Subjects must give their signed and dated written informed consent to participate. \n\n Gender: Male or Female \n\n Age: 40 years of age or older at Visit 1 \n\n COPD diagnosis: Documented diagnosis of COPD at least 6 months prior to Visit 1 in accordance with the following definition by the GOLD (Global Initiative for Chronic Obstructive Lung Disease) guideline: Post bronchodilator FEV1/FVC < 0.7. \n\n History of exacerbations: At least one COPD exacerbation which required the use of any additional treatment in the last 12 months prior to Visit 1. \n\n For subjects who were diagnosed between 6 to 12 months prior to Visit 1, they should have at least one COPD exacerbation that required the use of any additional treatment since diagnosis. \n\n Tobacco use: Smokers or ex-smokers with a smoking history of more than 10 pack years. \n\n ", - "exclusion_criteria": ": \n\n Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study \n\n Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if COPD is the current diagnosis. \n\n Non-compliance: Subjects unable to comply with any aspect of this study protocol or scheduled visits to the study centre", - "brief_summary": "Chronic Obstructive Pulmonary Disease (COPD) is a major health concern, with a substantial impact on a patient's life. However, the impact of COPD is currently under-recognised and, as a result, COPD is under-treated. An exacerbation of COPD is a major element that causes poor quality of life and loss of productivity. Therefore, minimizing the frequency of exacerbations is a short term treatment goal in COPD management and could improve Quality of Life (QoL) significantly in all severity groups of COPD.~Although the use of spirometry for the determination of disease severity in COPD is supported by guidelines, a lung function test alone does not provide a measurement of the overall impact of COPD on health status and is not generally available especially in primary care centre. Therefore, a standardised and effective dialogue between patients and physicians in a consultation could address the impact of COPD on a patient's QoL in this situation.~The COPD Assessment Test (CAT), recently launched in 2009, is a short and simple, self-administered questionnaire designed to assess the condition of patients and overall impact of COPD, and to improve patient-physician communication. It has been proven that the CAT has good repeatability and discriminative properties which suggest that it is sensitive to treatment effects at a group level. The CAT score with its better ability to assess the impact of COPD on patients, suggests potential to predict a significant change in COPD status such as acute exacerbations of COPD.~Since the CAT is designed to assess the impact of COPD on the patient by measuring overall impairment, it has better correlations with other instruments, such as the Clinical COPD Questionnaire (CCQ), MRC (Medical Research Council) dyspnoea scale, St George's Respiratory Questionnaire (SGRQ),and the 6-minute walk test. However, it does not correlate well with FEV1 (Forced Expiratory Volume in One Second).~While the CAT shares some similarities with other questionnaires, there are several important differences. For example, the SGRQ is substantially longer than the CAT, is complex to administer and requires the use of a computer for scoring. The CAT is designed to provide a holistic measure of the impact of COPD on the patient, whereas the MRC dyspnoea scale only measures dyspnoea, and the CCQ only assesses clinical disease control. Thus, the CAT is the only validated, short and simple assessment test which can provide a holistic measure of the impact of COPD on patients, ensuring both the physicians and the patients gain the understanding needed to manage COPD optimally.~QoL is defined as an individual's perception of their position in their life in the context of the culture and value systems. Therefore, the extent of understanding of the questionnaire might be influenced by language and ethnicities. Since the validation findings so far have been based on data from the US and Europe, PACE may provide better quality of data across ethnic groups given that mainly Asian subjects will participate in this study.~PACE is designed to evaluate whether the CAT has a high predictive value in detecting subsequent exacerbations of COPD. If so, this result might enable both patients and physicians to better target and optimise management. The primary objective is to evaluate the predictability of the CAT to have subsequent exacerbations in COPD patients. Secondary objectives are to evaluate the predictability of the CAT to have moderate to severe exacerbations or time to the first exacerbation, to identify risk predictors for COPD exacerbations, and to evaluate correlations between CAT scores and FEV1 values, or MRC dyspnea scores. An experimental objective is to evaluate the correlation between the CAT score between 2 consecutive follow-ups (e.g. Week 8 & baseline, Week 16 & Week 8) and a COPD exacerbation over the following treatment period adjusting for demographics, MRC scores, lung function parameters, medical history, and therapy history.~PACE is a multicentre, prospective, observational study designed to evaluate the predictability of the CAT score to have COPD exacerbations over 24 weeks. During the study, subjects continue taking their regular prescribed treatment. Investigators are free to make medication adjustments where required. Eligible subjects will have a clinic visit every 8 weeks, during which they will complete the CAT questionnaire, the Exacerbation Check List (ECL), MRC dyspnea scale, and spirometry. A regular phone call is placed every 8 weeks in between clinic visits to collect data for the ECL.There is no follow-up period.~550 male and female outpatient subjects will be recruited for PACE to obtain approximately 300 exacerbation events. This study will capture the winter periods in Australia, China, Korea and Taiwan, when incidence of exacerbations is at its peak.~Statistical analysis will be performed on subjects' data to derive the PACE end-points.", - "NCTID": "NCT01254032" - }, - { - "brief_title": "Chronic Obstructive Pulmonary Disease (COPD)-Related Outcomes and Costs for Patients on Combination Fluticasone Propionate-Salmeterol Xinafoate 250/50mcg Versus Anticholinergics in a COPD-Comorbid Depression/Anxiety Population", - "phase": "", - "drugs": "['fluticasone propionate/salmeterol xinafoate', 'Anticholinergics']", - "drugs_list": [ - "fluticasone propionate/salmeterol xinafoate", - "Anticholinergics" - ], - "diseases": "['Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "1.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of COPD in any field in the pre-index period and 60 days after the index date \n\n Diagnosis of depression/anxiety in any field and a medication for treating depression/anxiety in the pre-index period and 60 days after the index date \n\n Index date occurs during identification period \n\n Patients must be continuously eligible during 1-year pre and 1-year post-index date and be of at least 40 years of age \n\n ", - "exclusion_criteria": ": \n\n comorbid conditions (respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis, and bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, sarcoidosis) during the 1 year pre or post-index periods \n\n No other maintenance medications other than the index medication on or 60 days after the index date", - "brief_summary": "The objective of this study was to examine COPD-related outcomes for patients with comorbid depression/anxiety who are on combination fluticasone propionate/salmeterol xinafoate compared to those receiving anticholinergics.~The prevalence of comorbid depression/anxiety in patients with chronic obstructive pulmonary disease (COPD) is estimated to be high and range from 10-40%, given that the risk of depression/anxiety symptoms is almost 3 times higher in patients with versus without COPD. Additionally, patients with comorbid COPD and depression/anxiety have higher COPD-related healthcare utilization and costs compared to those without depression/anxiety. Therapy with maintenance medications for COPD has been recommended to prevent future adverse COPD outcomes, but the impact of initiating these interventions has not yet been evaluated in a higher-risk population with comorbid COPD-depression/anxiety. The present study compares the risk of COPD exacerbations and COPD-related costs in patients initiating maintenance medications for treatment of COPD in a comorbid COPD/depression-anxiety population. Maintenance medications include inhaled corticosteroid (ICS), long-acting beta agonist (LABA), combination drug product of ICS+LABA, and anti-cholinergics (AC) including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively abbreviated as IPR).", - "NCTID": "NCT01337336" - }, - { - "brief_title": "Pennsylvania Study Of Chronic Obstructive Pulmonary Exacerbations", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "1066.0", - "inclusion_criteria": "inclusion criteria: \n\n Phase 1 & Gene Expression: --Current hospitalization for COPD exacerbation \n\n Phase 1 & 2: COPD & ONE of the following criteria: \n\n History of hospitalization for COPD exacerbation, OR \n\n Currently on supplemental oxygen, OR \n\n History of evaluation for lung transplant or LVRS, OR \n\n >/= 6 months post-LVRS \n\n Phase 1 or 2: \n\n Current or former smoker, >/= 20 pack-yr. smoking history \n\n FEV1 6 months \n\n ", - "exclusion_criteria": ": \n\n < 20 pack-yr. smoking history \n\n Diagnosis of pulmonary fibrosis, bronchiectasis, mediastinal mass, or presence of a pulmonary mass \n\n Asthma \n\n FEV1 > 70% or FEV1/FVC >70%", - "brief_summary": "The overall purpose of PA-SCOPE is to determine why black and rural residents of Pennsylvania might be at higher risk for deadly, debilitating, and costly hospitalizations for chronic obstructive pulmonary disease (COPD)- and then to show that repeat acute exacerbations in high-risk patients can be reduced with one simple intervention. We believe that 1) COPD patients who are black or who live in rural areas of Pennsylvania are at higher risk of acute exacerbations requiring hospitalization and 2) this elevated risk can be reduced with one simple intervention: access to a 1-800 Temple Call Center where patients can get immediate customized advice on managing COPD exacerbations in their early stages. We will test these beliefs in PA-SCOPE. The collaborators with Temple University Hospital on the PA-SCOPE project are Lancaster General Hospital, Western Pennsylvania Hospital, and the Philadelphia College of Osteopathic Medicine.", - "NCTID": "NCT00774176" - }, - { - "brief_title": "Antibiotic or Not in Non-purulent Exacerbations of COPD: a Trial of Security and Efficacy", - "phase": "Phase 4", - "drugs": "['Moxifloxacin']", - "drugs_list": [ - "Moxifloxacin" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "73.0", - "inclusion_criteria": "inclusion criteria: \n\n COPD diagnosis according to GOLD guidelines \n\n Hospitalization for any acute exacerbation of chronic obstructive pulmonary disease \n\n Failure of outpatient treatment \n\n Increasing of dyspnea in the last days \n\n Comorbidity that causes detriment of respiratory function \n\n ", - "exclusion_criteria": ": \n\n Life expectancy of less than 6 months \n\n Mechanical Ventilation \n\n Cardiovascular condition that causes exacerbation \n\n Immunosuppression \n\n Pulmonary infiltrates that suggest pneumonia \n\n Antibiotic treatment in the last month \n\n Pregnancy \n\n ECG with a large QT segment \n\n Hypokalemia \n\n Hepatic failure or renal failure", - "brief_summary": "COPD is one of the most important causes of morbidity and mortality and supposes a sanitary problem in Europe and USA. Patients with COPD usually have 1-2 episodes of acute exacerbation of COPD (AECOPD) per year, being these the principal causes of of hospitalizations, respiratory problems and medical visits. After an episode of AECOPD, the majority of patients develop a transitory (or permanent) worsening in their quality of life and 50% of them will require a new hospitalization. Globally, a 75%& of the exacerbations might be associated with a respiratory tract infection, and among them, 50% might be related to bacteria and in 45% an evidence of viral infection could be documented. Even though the antibiotic treatment might not be useful for a majority of patients with AECOPD, is generalized its use(almost an 85% in some series) in hospitalized patients. The non-controlled use of antibiotics in AECOPD results in a very expensive disease and raises the rate of resistance of bacteria. The available literature have shown that there's a relation between exacerbations and infections, based on sputum samples.~In summary, is well known that at least a 50% of the episodes of AECOPD might be associated with pathogenic bacteria in the lower respiratory tract. Prescription of antibiotics is wide and generalized in hospitalized patients. Clinical trials have shown correlation between AECOPD with sputum purulence (which correlates with presence of bacteria), however they've not included NON-purulent AECOPD, even though they're a significative group of patients hospitalized by this cause too. It's necessary to evaluate the efficacy nor the security of antibiotic treatment in this group of patients in a well designed trial.", - "NCTID": "NCT01091493" - }, - { - "brief_title": "Effects of Inhaled Corticosteroids on Sputum Bacterial Load in COPD", - "phase": "", - "drugs": "['Salmeterol/Fluticasone combination', 'Salmeterol']", - "drugs_list": [ - "Salmeterol/Fluticasone combination", - "Salmeterol" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Sixty stable moderate COPD patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2) requiring regular treatment with long-acting bronchodilators, according to international guidelines. \n\n GOLD stage 2 COPD patients will be enrolled providing they were steroid-free for the last 4 months \n\n ", - "exclusion_criteria": ": \n\n Atopy \n\n Asthma \n\n Concomitant lung diseases (e.g. lung cancer) \n\n Acute infections of the respiratory tree in the previous 3 months including COPD exacerbation.", - "brief_summary": "Exacerbations are important events in the natural history of chronic obstructive pulmonary disease (COPD). Beside the acute (and prolonged) clinical impact, there is evidence that exacerbations negatively affect the natural history of the disease; e.g. lung function decline is accelerated in patients with frequent exacerbations. Bacteria are considered the most relevant cause of exacerbations, but there is evidence that viral infections are equally contributing.~Either alone or in combination with viruses, airway bacterial load in stable COPD correlates with both the frequency of exacerbations and the decline in lung function.~A long-term clinical trial recently showed that the regular treatment with inhaled corticosteroids (ICS) increases the risk of infectious events such as pneumonia, whereas it reduces the frequency of acute COPD exacerbations in COPD.~In a recent study it was found that airway bacterial load increases over time (1 yr follow up) in stable COPD. In this study, virtually all patients (93%) were treated with ICS.~This study is designed to evaluate whether long-term (1 year) ICS treatment increases viral and/or bacterial load in the sputum of COPD patients.", - "NCTID": "NCT01213693" - }, - { - "brief_title": "Macrolides to Prevent Exacerbations of Asthma and Chronic Obstructive Pulmonary Disease", - "phase": "Phase 2", - "drugs": "['azithromycin']", - "drugs_list": [ - "azithromycin" - ], - "diseases": "['Asthma', 'Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Asthma", - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "18.0", - "inclusion_criteria": "inclusion criteria: \n\n Physician-diagnosis of asthma, COPD exacerbation, or undifferentiated asthma/COPD exacerbation \n\n Admitted to the inpatient medical service at Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center \n\n Evidence of airflow obstruction on spirometry (FEV1/FVC<70%) \n\n Age 18 years or older \n\n ", - "exclusion_criteria": ": \n\n History of allergy or other contraindication to macrolides (azithromycin, erythromycin, clarithromycin) \n\n Treatment with any macrolide in the 4 weeks prior to study entry \n\n Elevated AST or ALT (2 or more times the upper limit of normal) on current admission \n\n Elevated alkaline phosphatase (>1.25 times the upper limit of normal) on current admission \n\n Elevated total serum bilirubin (more than upper limit of normal) on current admission \n\n Previous participation in this study \n\n Patients prescribed digoxin (azithromycin may increase digoxin levels) \n\n Patients prescribed warfarin (azithromycin may increase INR in patients on warfarin) \n\n Patients prescribed pimozide (azithromycin may increase risk of arrhythmias) \n\n Patient unable to provide consent (e.g., language difficulty or history of dementia) \n\n Patient to be discharged to a location other than home (e.g., other hospital, long-term care facility)", - "brief_summary": "The purpose of this study is to determine whether macrolide therapy is effective in treating patients hospitalized with asthma exacerbations or chronic obstructive pulmonary disease (COPD)exacerbations. We hypothesize that compared to placebo, maintenance therapy with macrolides, when added to usual care, a) improves respiratory symptoms, b) improves quality of life, c) reduces airway inflammation, d) reduces airflow obstruction, and e) decreases the rate of re-exacerbations.", - "NCTID": "NCT00181272" - }, - { - "brief_title": "Molecular, Cytological Features and Genetic Susceptibility of COPD Attributable to Different Environmental Exposures", - "phase": "", - "drugs": "['exposure to respirable silica dust', 'exposure to polycyclic aromatic hydrocarbons exhaust']", - "drugs_list": [ - "exposure to respirable silica dust", - "exposure to polycyclic aromatic hydrocarbons exhaust" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "352.0", - "inclusion_criteria": "inclusion criteria: \n\n Post- bronchodilator forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ratio less than 0.7 \n\n Stable phase of COPD \n\n History of exposure to respirable silica dust, nonsmokers with absence of passive exposure to tobacco smoke or history of exposure to polycyclic aromatic hydrocarbons exhaust, nonsmokers with absence of passive exposure to tobacco smoke or current tobacco smokers without history of occupational exposure \n\n COPD risk factor exposure (occupational or tobacco smoke) duration not less than 12 months \n\n Male \n\n Caucasian \n\n Age of 40 - 75 years old \n\n Control group - healthy people \n\n ", - "exclusion_criteria": ": \n\n history of biomass smoke exposure \n\n age less than 40 and above 75 years old \n\n current COPD exacerbation \n\n concomitant asthma \n\n tuberculosis and other pulmonary diseases \n\n allergic and autoimmune disorders \n\n active infections \n\n immunodeficiency, including HIV infection \n\n parasitological diseases \n\n malignancies \n\n lack of informed consent", - "brief_summary": "The objective of this study is to investigate molecular, cytological and genetic features of occupational chronic obstructive pulmonary disease (COPD) in conditions of different occupational exposures. In order to achieve this goal serum pro-inflammatory cytokines and standard inflammation markers level, hemostasis, cytological analysis of bronchoalveolar lavage and associations of single nucleotide polymorphisms (SNPs) rs1800470 transforming growing factor \u03b21 (TGF \u03b21) gene, rs1828591 hedgehog interacting protein (HHIP) gene, rs4129267 interleukin 6 receptor (IL-6R) gene, rs1051730 nicotinic acetylcholine receptor 3 (CHRNA3) gene with COPD in subjects exposed to silica dust and in those exposed to polycyclic aromatic hydrocarbons exhaust will be investigated. The relationship between genotype and phenotype characteristics, such as an inflammation activity, assessed by C-reactive protein (hsCRP) and tumor necrosis factor-\u03b1 (TNF \u03b1) serum concentration, in different occupational COPD groups will be studied. The hypothesis is that the mechanisms underlying disease development and progression are different due to environmental risk factor that reflex in differs in disease attributes - molecular biomarkers, cytology results and genetic susceptibility between COPD due to dust, COPD due to chemicals and COPD in smokers therefore COPD can be subdivided into ecological phenotypes according to environmental risk factor.", - "NCTID": "NCT02220387" - }, - { - "brief_title": "Placebo Versus Antibiotics in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)", - "phase": "Phase 4", - "drugs": "['doxycycline']", - "drugs_list": [ - "doxycycline" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "258.0", - "inclusion_criteria": "inclusion criteria: \n\n Acute exacerbation of COPD type I or II according to GOLD \n\n Ability to perform lung function tests \n\n Ability to take oral medication \n\n ", - "exclusion_criteria": ": \n\n Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception. \n\n Pretreatment ( > 24 hours) with an antibiotic for the present exacerbation. \n\n Pretreatment with corticosteroids (>30 mg for more than 4 days) for the present exacerbation. \n\n Progression or new radiographic abnormalities on the chest X-ray. \n\n Severe exacerbation that required mechanical ventilation. \n\n History of bronchiectasis \n\n Recent or unresolved lung malignancy. \n\n Other disease likely to require antibiotic therapy. \n\n Significant gastrointestinal or other conditions that may affect study drug absorption. \n\n Class III or IV congestive heart failure or stroke. \n\n Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc. and the use of immunosuppressive drugs (>30 mg prednisolone maintenance dose or equivalent for more than 4 weeks). \n\n Cystic fibrosis \n\n Tuberculosis. \n\n Impaired renal function (creatinine clearance < 20 ml/min).", - "brief_summary": "The role of antibiotic therapy in patients with COPD remains controversial. While the outcome of several clinical trials is in favour of antibiotics, the quality of these studies in insufficient. In this study the efficacy of doxycycline is compared to placebo. All concommitant treatment (steroids, bronchodilator therapy, physiotherapy) is standardized.~The investigators hypothesize that patients with an acute exacerbations will have a better outcome when treated with antibiotics.", - "NCTID": "NCT00170222" - }, - { - "brief_title": "PPSV23 Pneumococcal Vaccine in Chronic Obstructive Pulmonary Disease (COPD)", - "phase": "Phase 4", - "drugs": "['PPSV23 pneumococcal vaccine (Pneumovax\u00ae)', 'Normal Saline']", - "drugs_list": [ - "PPSV23 pneumococcal vaccine (Pneumovax\u00ae)", - "Normal Saline" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "38.0", - "inclusion_criteria": "inclusion criteria: \n\n no previously vaccination with PPSV23, \n\n a clinical diagnosis of severe COPD which is defined according to the GOLD 2006 guideline (11): FEV1/FVC < 70%, FEV1 reversibility test < 200 ml, and FEV1 < 50% of predicted, \n\n current or past exposure of smoking, \n\n no exacerbation in the month prior to enrollment, \n\n age < 65 years, \n\n using high daily dose of ICS (budesonide > 800-1600 mcg/day or fluticasone > 500-1000 mcg/day), \n\n providing written informed consent. \n\n ", - "exclusion_criteria": ": \n\n Patients are excluded from the study if they are pregnant, or have immunosuppressed status (known current neoplasm, renal insufficiency in dialysis, human immunodeficiency virus (HIV) infection, severe hepatic impairment, hypogammaglobulinemia, anatomical or functional asplenia). \n\n Asthma, cystic fibrosis, bronchiectasis, and severe sequelae of pulmonary tuberculosis are also excluded by pulmonary function study and chest imaging before patient's enrollment.", - "brief_summary": "Streptococcus pneumoniae is the most common causes of community-acquired pneumonia and exacerbations in chronic obstructive pulmonary disease (COPD) patients, which are associated with morbidity, mortality, and higher health-care cost. In addition, recently high daily dose of inhaled corticosteroid (ICS) therapy became more evident to be beneficial in moderate-to-severe COPD patients, but excess risk of pneumonia shown in database analysis was worried about by primary physicians. The use of pneumococcal polysaccharide vaccination (PPSV23) has protective efficacy to eliminate infection of Streptococcus pneumoniae from previous studies. If the use of PPSV23 can reduce the incidence of pneumonia or exacerbations in COPD patients using high daily dose of ICS, the benefit of ICS can be preserved and risk of pneumonia can be reduced. However, there is only limited data supporting this hypothesis. In this study, the investigators will conduct a double-blinded, randomized controlled trial to evaluate the clinical efficacy of PPSV23 in severe COPD patients using high daily dose of ICS.", - "NCTID": "NCT01381367" - }, - { - "brief_title": "Responses Induced by Smoking in Individuals Being Susceptible and Non-Susceptible for Development of COPD", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18-75 years \n\n Age, pack years, FEV1/FVC and FEV1% predicted must fit in one of the 5 groups described above. \n\n Able to stop smoking for 10 days and start smoking 3-4 cigarettes within 1 hour \n\n Physically and mentally able to undergo the total study protocol \n\n Written informed consent \n\n ", - "exclusion_criteria": ": \n\n Participation in another study \n\n Alpha-1-antitrypsin deficiency \n\n Selected grade 1-3 co-morbidity listed in the ACE-27 \n\n Active pulmonary infection like tuberculosis, pneumonia, flue, tracheobronchitis \n\n Active extra-pulmonary infection like hepatitis A-C, cystitis, gastro-enteritis etc \n\n Pulmonary diseases like sarcoidosis, IPF, silicosis, hypersensitivity pneumonitis \n\n Life threatening diseases like carcinoma, AIDS (including HIV+), acute leukaemia etc \n\n Medication that may affect the results of the study: NSAID's, immunosuppressive agents like prednisolon, metotrexate, azathioprine,Acenocoumarol", - "brief_summary": "COPD is ranked number 3 by the WHO list of important diseases worldwide and is the only disease with increasing mortality. The pathogenesis of cigarette smoke-induced COPD is obscure, therefore more insight is needed to design effective anti-inflammatory agents. We hypothesize that healthy individuals who are susceptible to smoking demonstrate a higher and aberrant inflammatory response to cigarette smoke. This susceptibility is caused by heterogeneous factors and is associated with various polymorphic genes that interact with each other and with the environment.~Objective:~To define mediators involved in the early induction of COPD in susceptible smokers (and so to define new drug targets)~To develop new biological and clinical markers for the early diagnosis and monitoring of COPD~To compare between susceptible and non-susceptible individuals the corticosteroid responsiveness of bronchial epithelial cells in vitro, and to study the mechanisms of smoking-induced corticosteroid unresponsiveness.~To study the role of candidate genes that may play a role in the development of fixed airway obstruction, and to identify clues for patient's responsiveness to specific drugs.", - "NCTID": "NCT00807469" - }, - { - "brief_title": "The Use of a Forecasting System for Predicting Exacerbations of COPD", - "phase": "Phase 1", - "drugs": "['COPD self care advice', 'Poor weather forecast warning']", - "drugs_list": [ - "COPD self care advice", - "Poor weather forecast warning" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease (COPD)']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease (COPD)" - ], - "enrollment": "98.0", - "inclusion_criteria": "inclusion criteria: \n\n Current or former smokers with a diagnosis of COPD \n\n Having impaired lung function as measured by spirometry \n\n ", - "exclusion_criteria": ": \n\n History of asthma or nasal symptoms caused by hayfever \n\n No telephone \n\n Inability to record symptoms in an electronic diary (PDA)", - "brief_summary": "People with Chronic Obstructive Pulmonary Disease (COPD) often have periods during the year when their symptoms become worse. These are often due to an infection and are called exacerbations by doctors. Exacerbations are more common in the winter and also seem to be related to particular types of weather. As well as forecasting the weather the UK Met Office has developed a system to try to predict when exacerbations are likely to occur. The main purpose of this research study is to find out whether the Met Office forecasting service can predict when exacerbations are more likely to occur and whether the advice given during the predicted higher risk periods leads to fewer patients having an exacerbation or if it reduces the impact of the exacerbation. The study will also assess if there is a link between viral or bacterial infection and breathing problems that occur during the study period. The study will also collect information about possible causes of the breathing problems and what happens to the person afterwards. The results of this study will help us learn more about breathing problems which may lead to new research studies that would aim to improve the care of people with COPD.", - "NCTID": "NCT00788645" - }, - { - "brief_title": "Strategy for Early Treatment of Exacerbations in COPD: Standing Prescriptions of Advair With a Written Action Plan in the Event of an Exacerbation", - "phase": "Phase 4", - "drugs": "['Double dose of Salmeterol + Fluticasone Propionate', 'Self-management education on the use of a self-administered prescription for exacerbation.', 'Self-administered prescription']", - "drugs_list": [ - "Double dose of Salmeterol + Fluticasone Propionate", - "Self-management education on the use of a self-administered prescription for exacerbation.", - "Self-administered prescription" - ], - "diseases": "['COPD', 'Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "COPD", - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "37.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of stable COPD; \n\n 40 years or older; \n\n Smoking history of at least 10 pack-years; \n\n Forced Expiratory Volume in one second (FEV1) \u2264 70 % of predicted value and FEV1 / Forced Vital Capacity (FVC) < 0.70; \n\n Dyspnea \u2265 2 on the Medical Research Council (MRC) scale; \n\n At least 2 exacerbations requiring prednisone treatment in the past 3 years; \n\n Using a written action plan and having demonstrated adequate use of the self-administered antibiotic & prednisone (adequate use defined as prednisone started by the patient within 72 hours of symptom worsening and patient called the case-manager as recommended for following the response); \n\n Already on Advair BID (twice a day) as a maintenance therapy or able to switch over to Advair if already taking another combination medication (Symbicort) as maintenance therapy for COPD. \n\n ", - "exclusion_criteria": ": \n\n History of asthma or allergic rhinitis before the age of 40; \n\n Regular use of oxygen, oral corticosteroids, antibiotics; \n\n Unstable or life threatening co-morbid condition; \n\n Medical conditions or taking medications known to affect tremor and/or heart rate (HR). \n\n Pre-existing medical conditions or on concomitant medications contraindicated with salmeterol or fluticasone propionate (e.g. monoamine oxidase inhibitors and tricyclic antidepressants, beta-adrenergic receptor blocking agents, non potassium-sparing diuretics, inhibitors of cytochrome P450 (ritonavir, ketoconazole)); \n\n On theophyllines. \n\n Colonized with pseudomonas aeruginosa.", - "brief_summary": "The purpose of this pilot study is to determine whether early treatment of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) with a combination therapy, Salmeterol + Fluticasone Propionate (SFP - Advair) will reduce the use of prednisone, known as the conventional treatment.~Primary objective: To determine whether early treatment with combination therapy (SFP) can reduce the use of prednisone (the conventional treatment) in the event of an AECOPD.~Secondary objectives:~To evaluate the feasibility of this treatment approach and to provide pilot data (needed for a larger multi-centre clinical trial;~To evaluate the feasibility and need of assessment during and after exacerbation onset, health-related quality of life and physical activity;~To evaluate the safety of this approach; this is in terms of the delay in starting prednisone and an unfavourable outcome (ER visits and/or hospitalization).", - "NCTID": "NCT02136875" - }, - { - "brief_title": "Molecular, Cytological Features and Genetic Susceptibility of COPD Attributable to Different Environmental Exposures 2", - "phase": "", - "drugs": "['exposure to respirable silica dust', 'exposure to aromatic hydrocarbons']", - "drugs_list": [ - "exposure to respirable silica dust", - "exposure to aromatic hydrocarbons" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "352.0", - "inclusion_criteria": "inclusion criteria: \n\n Post- bronchodilator forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ratio less than 0.7 \n\n Stable phase of COPD \n\n History of exposure to respirable silica dust, nonsmokers with no of passive exposure of tobacco smoke or history of exposure to aromatic hydrocarbons, nonsmokers with no of passive exposure of tobacco smoke or current tobacco smokers without history of occupational exposure \n\n COPD risk factor exposure (occupational or tobacco smoke) duration not less than 12 months \n\n Male \n\n Caucasian \n\n Age of 40 - 75 years old \n\n ", - "exclusion_criteria": ": \n\n history of biomass smoke exposure \n\n age less than 40 and above 75 years old \n\n current COPD exacerbation \n\n concomitant asthma \n\n tuberculosis and other pulmonary diseases \n\n allergic and autoimmune disorders \n\n active infections \n\n immunodeficiency, including HIV infection \n\n parasitological diseases \n\n malignancies \n\n lack of informed consent.", - "brief_summary": "The objective of this study is to investigate molecular, cytological and genetic features of occupational chronic obstructive pulmonary disease (COPD) in conditions of different occupational exposures. In order to achieve this goal serum pro-inflammatory cytokines and standard inflammation markers level, hemostasis, cytological analysis of bronchoalveolar lavage fluid and association of single nucleotide polymorphisms (SNPs) rs1800470 transforming growing factor \u03b21 (TGF \u03b21) gene, rs1828591 hedgehog interacting protein (HHIP) gene, rs4129267 interleukin 6 receptor (IL-6R) gene, rs1051730 nicotinic acetylcholine receptor 3 (CHRNA3) gene with COPD in subjects exposed to silica dust and in those exposed to polycyclic aromatic hydrocarbons exhaust will be investigated. The relationship between genotype and phenotype characteristics, such as an inflammation activity, assessed by C-reactive protein (hsCRP) and tumor necrosis factor alpha (TNF \u03b1) serum concentration, in different occupational COPD groups will be studied. The hypothesis is that the mechanisms underlying disease development and progression are different due to environmental risk factor that reflex in differs in disease attributes - molecular biomarkers, cytology results and genetic susceptibility between COPD due to dust, COPD due to chemicals and COPD in smokers therefore COPD can be subdivided into ecological phenotypes according to environmental risk factor.", - "NCTID": "NCT02284295" - }, - { - "brief_title": "Outcomes Associated With Early or Delayed Maintenance Treatment Post-Chronic Obstructive Pulmonary Disease Exacerbation", - "phase": "", - "drugs": "['Early maintenance treatment', 'Delayed Maintenance treatment']", - "drugs_list": [ - "Early maintenance treatment", - "Delayed Maintenance treatment" - ], - "diseases": "['Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "3806.0", - "inclusion_criteria": "inclusion criteria: \n\n at least 40 years of age, \n\n continuously enrolled for medical and pharmacy benefits during their pre- and post-period \n\n diagnosis of COPD (ICD 491.xx, 492.xx, 496.xx) \n\n ", - "exclusion_criteria": ": \n\n Patients were excluded if they had MTx in the pre-index period (to ensure inclusion of MTx-na\u00efve patients) or if they received their first MTx during 181 to 365 days of the post-period (as dispensing of MTx unlikely to be related to the index exacerbation). \n\n Additionally, patients were excluded if they had any of the following comorbid conditions anytime during the study period: respiratory cancer, cystic fibrosis, fibrosis due to, bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, or sarcoidosis, and \n\n also if they had other doses (unapproved in the US) of fluticasone propionate-salmeterol xinafoate combination (100/50 mcg or 500/50 mcg) or budesonide dipropionate-formoterol fumarate fixed dose combination (any dose).", - "brief_summary": "The timing of initiating short-term treatment for COPD exacerbations with oral corticosteroids and/or antibiotic therapy has been shown to influence the recovery time of exacerbations with early initiation of exacerbation therapy having a faster symptom recovery compared to delayed initiation. While oral corticosteroids and/or antibiotic therapy are crucial for immediate exacerbation therapy, maintenance therapy with controller medications for COPD has been recommended to reduce the risk of future exacerbations. The initiation of maintenance therapy after a COPD exacerbation has been shown to be beneficial in the reduction of risk of future exacerbations. However, there is a lack of information on whether the timing of this initiation influences the risk of future exacerbations. The following study evaluates the impact of early versus delayed initiation of controller medication therapy for maintenance treatment following a COPD-related exacerbation on outcomes of future exacerbations and costs in patients with COPD.", - "NCTID": "NCT01431911" - }, - { - "brief_title": "The Effect of N-Acetylcystein on Quality of Life and Air Trapping During Rest and After Exercise", - "phase": "Phase 4", - "drugs": "['Effect on small airways (N-Acetylcystein)']", - "drugs_list": [ - "Effect on small airways (N-Acetylcystein)" - ], - "diseases": "['Quality of Life', 'Exercise']", - "diseases_list": [ - "Quality of Life", - "Exercise" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n 30 Moderate COPD (GOLD classification) , AGE 45-70, both sexes. \n\n Treated with inhaled steroids and long acting beta agonists. \n\n ", - "exclusion_criteria": ": \n\n Active ischemic heart disease, heart failure, orthopedic problems that preclude ergometric bicycle activity.", - "brief_summary": "Treatment of COPD patients depends on the stage of the disease. First of all it is strongly recommended quit smoking, then bronchodilators drugs are added. In more advanced stages inhaled corticosteroids and pulmonary rehabilitation are added. In hypoxemic patients a long term supplemental oxygen is advised.~The addition of sputum modifiers drugs is equivocal, since no objective improvement was documented.~N-Acetylcystein (NAC) is a drug known for its anti-oxidant and mucolytic activity. In animal models of disease it showed its beneficial activity , whereas in human such changes weren't demonstrated. In all the studies FEV1 was used to demonstrate the beneficial effect of the drug, although the disease changes are at the level of small airways which is almost not expressed by the measurement FEV1.~Purpose of the study~To estimate the damage severity at the small airways.~To estimate the change in quality of life.~To assess the pulmonary function changes at rest and following exercise, including parameters of air trapping (hyperinflation)~Methods & Materials Patients - Inclusion - 30 Moderate COPD (GOLD classification) , AGE 45-70, both sexes. Treated with inhaled steroids and long acting beta agonists.~Exclusion - Active ischemic heart disease, heart failure, orthopedic problems that preclude ergometric bicycle activity.~Questionnaire - The St. George questionnaire for quality of life will be used . Pulmonary function testing- Lung volumes and spirometry un including inspiratory capacity will be measured before and after exercise.~Study protocol - 2 weeks run in, for observation disease stability and drug adherence.~Patient will randomly separated in 2 groups . Group A - will receive 600-1200 mg N-acetyl cystein twice daily. Group B - will receive as control placebo . Following 4 weeks of treatment patient will clinically re-examined and PFT's performed as described. After 2 weeks of washout group A. will serve as control and group B. will be treated with NAC as described.", - "NCTID": "NCT00476736" - }, - { - "brief_title": "Association Between Increased Oxidative Stress, Anti-Inflammatory Fatty Acid Formation, and Airway Infection in People With Asthma and Chronic Obstructive Pulmonary Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Asthma', 'Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Asthma", - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "43.0", - "inclusion_criteria": "inclusion criteria: \n\n No change from the MIA and LEUKO trials \n\n ", - "exclusion_criteria": ": \n\n No change from the MIA and LEUKO trials", - "brief_summary": "Chronic obstructive pulmonary disease (COPD) and asthma are common respiratory diseases in which people experience long-term inflammation of the lungs. Exacerbations, or prolonged worsening of symptoms, of asthma and COPD are often life-threatening and can lead to frequent need for hospitalization. Even with the proper use of bronchodilators, corticosteroids, and other currently available medications, clinical responses among people with COPD and asthma are variable. There remains a significant unmet clinical need for new therapeutic approaches and insights, including the identification of biomarkers to accurately assess the presence of airway infection and intensity of airway inflammation. This study will investigate potential natural biological causes and new biomarkers for increased susceptibility to persistent airway infection in asthma and COPD.", - "NCTID": "NCT00595114" - }, - { - "brief_title": "Withdrawal of Inhaled Corticosteroids in Patients With COPD in Primary Care", - "phase": "Phase 4", - "drugs": "['Fluticasone 500mcg BD via accuhaler or identical placebo']", - "drugs_list": [ - "Fluticasone 500mcg BD via accuhaler or identical placebo" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "256.0", - "inclusion_criteria": "inclusion criteria: \n\n Smoker or ex smoker of at least 10 pack years \n\n Age 40 or above \n\n Prior and current use of inhaled corticosteroids for at least 6 months duration (Used for at least 75% of time on direct questioning) \n\n FEV1 <80% of predicted, FEV1/FVC ratio <70%. \n\n Less than 15% change and <200 mls change in FEV1 20 minutes after 5 mg nebulised salbutamol. \n\n 256 patients to be included in trial of which 196 must have had a precious exacerbation of COPD in the last year \n\n ", - "exclusion_criteria": ": \n\n Clear history of asthma, bronchiectasis, carcinoma of bronchus or other significant respiratory disease \n\n Inability to give informed consent (severe mental illness, mental handicap or brain damage). \n\n Recorded exacerbation within last month that has required antibiotics or steroids (delayed randomisation) \n\n Classification as a never smoker \n\n Strongly positive skin allergy result (>10mm skin weal greater then negative control) to house dust mite, grass, tree, aspergillus, cat, dog or weed (irrespective of asthma/atopy status)", - "brief_summary": "Guidelines recommend inhaled corticosteroids (ICS) for patients with moderate to severe chronic obstructive pulmonary disease (COPD). Most COPD patients are managed in primary care and receive ICS long-term and irrespective of severity. The effect of withdrawing ICS from COPD patients in primary care is unknown.This randomised double-blind placebo-controlled trial will evaluate the effect of withdrawal of inhaled corticosteroids in patients with COPD recruited from general practice. Participants will have a clinical and spirometric diagnosis of COPD and will have been prescribed inhaled steroids for the 6 months before entry to the trial. They will be randomised to taking a fixed dose steroid inhaler (Flixotide Accuhaler) or an identical placebo inhaler. Patients will be monitored using diary cards for a year with 3 monthly follow-up visits at their general practice. The primary outcome measures will be exacerbation frequency and severity. Other outcomes are time to first exacerbation, costs, health status, lung function and unscheduled care. We tested the hypothesis that withdrawal of ICS in this population would lead to an increased number of exacerbations, earlier onset of exacerbation, and a worsening of symptoms.", - "NCTID": "NCT00440687" - }, - { - "brief_title": "Biomarker Assay Validation in Healthy Smokers and COPD Smokers and Ex-smokers", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['COPD', 'Asthma']", - "diseases_list": [ - "COPD", - "Asthma" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria for Healthy Smoking Subjects \n\n Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. \n\n Be between 18 and 75 years of age, inclusive, at informed consent. \n\n Healthy as determined by a physician, based on medical history and physical examination. \n\n Must have smoked regularly in the 12-month period preceding the screening visit and have a pack history of \u2265 5 pack years (number of pack years = number of cigarettes per day/20 x number of years smoked). \n\n inclusion criteria for All COPD Subjects \n\n Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. \n\n Aged between 40 and 75 years of age inclusive, at the time of signing the informed consent. \n\n COPD diagnosis: Subjects with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines (Celli, 2004). Symptoms must be compatible with COPD for at least 1 year prior to screening and post-bronchodilator spirometry readings at screening: \n\n Post-bronchodilator FEV1/FVC ratio of <0.7 \n\n Post-bronchodilator FEV \u226540 % and \u226480 % of predicted normal values calculated using NHANES reference equations. \n\n Additional Inclusion for Smoking COPD Subjects 1. Must have smoked regularly in the 12-month period preceding the screening visit and have a pack history of \u2265 5 pack years (number of pack years = number of cigarettes per day/20 x number of years smoked). \n\n ", - "exclusion_criteria": " for Healthy Smoking Subjects Any potential subject who meets any of the following criteria will be excluded from the participating study. \n\n Upper or lower respiratory tract infection within 4 weeks of the screening visit. \n\n Positive test for alcohol at screening. \n\n Taking prescription medication in the 14 days before screening. \n\n Subjects whose primary consumption of tobacco is via methods other than cigarettes (manufactured or self-rolled). Primary methods of tobacco consumption that are excluded include, but are not limited to pipes, cigars and e-cigarettes. \n\n Subjects who are unable to produce a total weight of at least 0.1 grams (g) of selected sputum at screening \n\n Urinary cotinine levels at screening < 30 ng/ml. \n\n Subject is mentally or legally incapacitated. \n\n Subject is an employee of the Sponsor or contract research organization (CRO), or a relative of an employee of the Sponsor or CRO. \n\n Any other reason that the Investigator considers makes the subject unsuitable to participate. \n\n ", - "brief_summary": "This study will collect sputum samples from healthy smokers, COPD smokers and COPD ex-smokers to analyse biomarkers of inflammation", - "NCTID": "NCT02490358" - }, - { - "brief_title": "Safety and Efficacy Study of Losmapimod (GW856553) in Frequently Exacerbating Participants With Chronic Obstructive Pulmonary Disease (COPD)", - "phase": "Phase 2", - "drugs": "['Losmapimod tablets', 'Placebo tablets', 'Salbutamol MDI']", - "drugs_list": [ - "Losmapimod tablets", - "Placebo tablets", - "Salbutamol MDI" - ], - "diseases": "['Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "184.0", - "inclusion_criteria": "inclusion criteria: \n\n COPD diagnosis and severity: Participants with a clinical history of COPD (established by a physician) in accordance with the following definition by the American Thoracic Society/European Respiratory Society, for at least 6 months prior to enrolment. Participants must have evidence of airflow obstruction, defined as post-bronchodilator FEV1 equal to or less than 80% of predicted normal value calculated using Third National Health and Nutrition Examination Survey (NHANES III) reference equation at Visit 1 and a FEV1 / FVC ratio <=70% at Screening (Visit 1). Note: Post-bronchodilator spirometry will be performed approximately 10-15 minutes after the participants has self-administered 4 inhalations (i.e., total 400/360 [microgram] mcg) of salbutamol/albuterol via a Metered Dose Inhaler (MDI) (use of spacer will be optional). The study-provided central spirometry equipment will calculate the FEV1/FVC ratio and FEV1 percent predicted values. \n\n Exacerbation History: A documented history (e.g., medical record verification) in the 12 months prior to Visit 1 of >=2 COPD exacerbations resulting in prescription for antibiotics and/or oral corticosteroids or hospitalisation or extended observation in a hospital emergency room or outpatient centre. Note: Prior use of antibiotics alone does not qualify as a moderate exacerbation unless the use was specifically for the treatment of worsening symptoms of COPD. \n\n Existing COPD maintenance treatment: Participants must be receiving daily maintenance treatment for their COPD for at least 3 months prior to Screening. Notes: Participants receiving only pro re nata or as needed (PRN) COPD medications are not eligible for inclusion in the study. All participants will continue on their current Standard of Care (SoC) COPD medications throughout the entire duration of the study. \n\n Tobacco use: Participants with a current or prior history of >=10 pack-years of cigarette smoking at Screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. One pack year =20 cigarettes smoked per day for 1 year or the equivalent. Number of pack years=(number of cigarettes per day/20) x number of years smoked. \n\n Sex: Male or female participants aged >=40 years at Screening (Visit 1). A female participant is eligible to participate if she is of non-child bearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milli-international unit/milliliter (MIU/mL) and estradiol <40 picogram/milliliter (pg/mL) (<140 [Picomoles per liter] pmol/L) is confirmatory] or if of child-bearing potential is using a highly effective method for avoidance of pregnancy from 30 days before the first dose, for the duration of dosing and until 2 weeks post last-dose. \n\n Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. \n\n Corrected ECG QT interval (QTc)<450 milliseconds(msec) or QTc<480 msec for participants with bundle branch block. The QTc is the QT interval corrected for heart rate according to either Bazett's formula (QTcB), Fridericia's formula (QTcF), or another method, machine or manual over-read. For eligibility and withdrawal, ideally the same QT correction formula will be used for all participants. However, because this is not always possible, the same QT correction formula will be used for each individual participant to determine eligibility for and withdrawal from the study. The QTc will be based on single or averaged QTc values of triplicate ECGs obtained over a brief recording period. \n\n ", - "exclusion_criteria": ": \n\n Eosinophils: >2.0% blood eosinophils at Screening (Visit 1) \n\n Concomitant medication: COPD Medication: Participants currently on chronic treatment with macrolides or Roflumilast; Long term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen PRN use (i.e. <=12 hours per day) is not exclusionary. Multidrug and toxin extrusion (MATE) transporter 1 (MATE1) inhibitors: cimetidine, pyrimethamine, trimethoprim (short course treatment with trimethoprim is allowed). Other medications: Chronic maintenance therapy with anti-Tumor Necrosis Factor (anti-TNF), anti-Interleukin-1 (anti-IL1), phosphodiesterase type 4 (PDE4) inhibitors, or any other immunosuppressive therapy (not including steroids) within 60 days prior to dosing. Any other investigational drug within 30 days or 5 half lives, whichever is longer prior to Screening Visit. \n\n Other respiratory disorders: Participants with asthma (as primary diagnosis) lung cancer, bronchiectasis, active sarcoidosis, active lung fibrosis, cystic fibrosis, idiopathic pulmonary hypertension, active interstitial lung diseases or other active pulmonary diseases. Participants with alpha-1-antitrypsin deficiency as the underlying cause of COPD. \n\n Participants with clinically significant sleep apnea who require use of continuous positive airway pressure (CPAP) device. \n\n Participants who require a non-invasive positive pressure ventilation (NIPPV) device (Note: Use of non invasive ventilation (NIV) in hospital as part of the medical management of an acute exacerbation is permitted.) \n\n Lung resection: Participants who have undergone previous lung reduction surgery (e.g. lobectomy, pneumonectomy, or lung volume reduction). \n\n COPD stability: Less than 30 days prior to Visit 1 have elapsed from completion of a course of antibiotics or oral corticosteroids for a recent COPD exacerbation. \n\n Evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD on chest X-ray (posteroanterior with lateral) or computerised tomography (CT) scan (historic data up to 1 year may be used). \n\n Pulmonary rehabilitation program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Participants who are in the maintenance phase of a pulmonary rehabilitation program are not excluded. \n\n Alanine aminotransferase (ALT) >2x Upper limits of normal (ULN) and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). \n\n Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). \n\n Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior to Visit 1 (Participants that had localized carcinoma of the skin or cervix which was resected for cure will not be excluded). \n\n Other diseases/abnormalities: History or current evidence of clinically significant or uncontrolled cardiovascular, pulmonary, metabolic, neurological, endocrine (including uncontrolled diabetes or thyroid disease), renal, hepatic, haematological (including agranulocytosis) or gastrointestinal conditions that are uncontrolled on permitted therapy and in the opinion of the investigator and/or GSK Medical Monitor, places the participant at an unacceptable risk as participant in this trial or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study \n\n Viral infections: Presence of hepatitis B surface antigen (HBsAg), Hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. Note: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C Ribonucleic acid (RNA) polymerase chain reaction (PCR) test is obtained. \n\n A positive test for human immunodeficiency virus (HIV) antibody \n\n Tuberculosis (TB): Participant with active TB or who have previously tested positive for latent TB and not received treatment or prophylaxis following the positive test. \n\n Vaccination: Participants who have received live attenuated vaccines in the 6 weeks prior to randomization. The use of live attenuated vaccines during the treatment period and in the 4 weeks post-discontinuation of investigational product is prohibited. \n\n Drug/food allergy: Participants with a history of hypersensitivity to any of the study medications (e.g., lactose, magnesium stearate). \n\n Lactating females \n\n Pregnant females (as determined by positive urine human chorionic gonadotropin (hCG) test prior to dosing). \n\n Drug/alcohol abuse: Participants with a known or suspected history of alcohol or drug abuse within the last 2 years. \n\n Prior use of study medication/other investigational drugs: Participants who have received an investigational drug within 30 days of entry into this study or within 5 drug half-lives of the investigational drug, whichever is longer. \n\n Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study. \n\n Inability to read: In the opinion of the investigator, any participant who is unable to read and/or would not be able to complete study related materials. \n\n Non-compliance: Participants at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits. \n\n Questionable validity of consent: Participants with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.", - "brief_summary": "This is a randomised, double-blind, parallel-group, multi-centre study evaluating 15 milligram (mg) twice daily/ Bi-daily (BID) of losmapimod versus placebo, in addition to standard of care (SoC).~The primary objective of this study is to explore the therapeutic potential of losmapimod as a treatment to reduce the rate of exacerbations in the subset of participants with moderate-to-severe COPD who are at high risk of exacerbation, having experienced two or more moderate/severe exacerbations in the preceding 12 months, and who have <=2% of blood eosinophils at screening. As secondary objectives safety, effects on lung function, quality of life, pharmacokinetic (PK), biomarkers of both disease and inflammation shall be evaluated.~The duration of the treatment period is variable but will be at least 26 weeks and up to a maximum of 52 weeks, with the end of study date being established once the final participant has been randomized. The purpose of the variable dosing regimen is to enable participants to remain in the study for a longer duration, as it is anticipated that this will increase the likelihood of observing exacerbation events without increasing the overall study duration. It will also enable safety data on dosing periods beyond 6 months to be generated.~Approximately 200 participants in a 1:1 ratio between losmapimod and placebo will be randomized to the study. Sample size re-estimation will be performed during the course of the study to potentially increase the sample size up to a maximum of 600 participants.", - "NCTID": "NCT02299375" - }, - { - "brief_title": "Procalcitonin To Reduce Antibiotics in Chronic Obstructive Lung Disease (ProToCOLD)", - "phase": "Phase 2; Phase 3", - "drugs": "['Discontinuation of Antibiotcs']", - "drugs_list": [ - "Discontinuation of Antibiotcs" - ], - "diseases": "['Chronic Obstructive Lung Disease']", - "diseases_list": [ - "Chronic Obstructive Lung Disease" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n 3.3. inclusion criteria and Recruitment Doctors in Pulmonary Medicine Department, Bispebjerg Hospital, which is involved directly in the treatment of patients who are potential candidates can be created as investigator after proper information and training. Then, these doctors include patients. Inclusion is based on the following in-and ", - "exclusion_criteria": " and after oral and written participant information. \n\n Inclusion: The following criteria must all be met for the patient can be First The patient must have confirmed / suspected COPD, and must be hospitalized with COPD exacerbation. \n\n Second The patient must be an adult (more than 18 years) and age. 3rd There must be a signed informed consent 4th Patients included only on weekdays. \n\n ", - "brief_summary": "Title: Pro-to-COLD, Procalcitonin to Chronic Obstructive Lung Disease,~COLD: Chronic Obstructive Lung Disease, Regarding: Patients hospitalized with suspected acute exacerbation of COPD + / - pneumonia.~Background: Patients with COPD exacerbation often get antibiotics. There is considerable criticism of this, many of these patients are not bacterially infected and the antibiotics overconsumption can lead to resistance development and side effects.~The purpose: To show that one can reduce the consumption of antibiotics among patients hospitalized for worsening of COPD disease in a population of Danish COPD patients by giving antibiotics depending on the value of the biomarker procalcitonin measured in the blood. A sub-objective is a validation study of mini VIDAS \u00ae / Biom\u00e9rieux equipment to the current gold standard in measuring procalcitonin, Kryptor/ BRAHMS.~Subjects: All patients with confirmed/suspected COPD admitted with COPD exacerbation to the Acute Admissions Unit/ Pulmonary dept. in weekdays. Participants must be adults and be of age and there must be a signed informed consent.~Method: 1) Controlled (Quasi-randomized): Even and uneven (concealed) digit of patient\u00b4s danish personal identification number, not last digit (gender-fixed) (CPR-number). Even = procalcitonin-guided, Uneven = Control.~2) Collect and analyze procalcitonin (PCT)-samples of patients in the PCT group at admission and then every 2 day. Samples analyzed throughout the week: Vital Status looked up 28 days after inclusion. Create a biobank in the study consisting of blood \u00e0 8 ml up to a maximum of 4 times taken for PCT measurements, the subsequent validation study of MiniVIDAS \u00ae. Biobank destroyed 15 years after the completed project.~Statistical considerations:~Sample size / Sample Size:~A total of 120 patients (please see the basis for this estimate of the Protocol).~Analyze:~A) Antibiotics stopped on day 5 B) Defined Daily Doses Reads aloud, 1) narrow spectrum, 2) broad spectrum, and 3) a total of the two groups between the (Mann-Whitney U test) C) Hospitalization within 28 days after the first hospitalization the year - the two groups between (Mann-Whitney U test). Doctor Jens-Ulrik Jensen stands for analyzes. Statistics program SAS v. 9.1.3 is used.~Economics: The study funded by the participating departments.~Responsibility: The study was conceived and run by doctors in Pulmonary Medicine Department and Department of Clinical Pharmacology, both Bispebjerg Hospital and Department of Clinical Microbiology, Hvidovre Hospital.~Science Ethics: There has been a thorough research ethics discussion of the project in the project with emphasis on an assessment of the advantages and disadvantages that might be for the participating patients and society as a whole now and in the future. Conclusions A and B of this discussion is summarized as:~A. Advantages and Disadvantages: The treating physician has at any time the opportunity to start / continue antibiotic behandlling for the overall assessment whether PCT value. In addition, in the past, in large studies with a total of> 2000 patients, demonstrated that there are drawbacks to the use of antibiotics depending on a displayed value of PCT in patients hospitalized with acute exacerbations of COPD. Mortality and hospitalization will be monitored in this study. However, there may occur side effects to blood sampling, usually transient ecchymosis blood sampling site. If the strategy results in a reduced consumption of antibiotics, it is expected that the incidence of antibiotic-associated adverse events decreased - this for the benefit of the patient.~B. Usefulness for society: Based on the results from this study will be a high degree of certainty to conclude whether this new treatment strategy can provide benefits for future patients in the form of reduced antibiotic consumption, less antibiotic associated adverse events, reduced resistance development / selection among bacteria and overall lower economic costs. Based on these considerations, believes the project, the project can be carried out with respect for the participating subjects to integrity.~Quantity: It is expected to be included 120 patients in this scientific study. Database: data (case report forms) stored in archive of Pulmonary Medicine Department for 15 years. Create a database with the information. Personally identifiable data will only be present in the clinical hospital. During the completion of the experiment can provide essential health information about the subject's state of health. This will the subject be informed, unless clearly opted out of this on the consent form. The project reported to the Data Protection Agency.~Level: With blood sample (8 mL) on day 1 and then every 2 days in the intervention group (the active group), this part of routine blood sampling. At discharge stops blood and the patient should not attend the blood after discharge.", - "NCTID": "NCT01950936" - }, - { - "brief_title": "Corticosteroids and Hemoglobin A1C Levels in Diabetic Patients With COPD Exacerbation", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Diabetes', 'Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Diabetes", - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "42.0", - "inclusion_criteria": "inclusion criteria: \n\n Diabetic patients with COPD exacerbation \n\n ", - "exclusion_criteria": ": \n\n Patients treated with steroids during the previous 3 months", - "brief_summary": "Corticosteroid treatment in diabetic patients admitted for COPD exacerbation are expected to significantly increase hemoglobin A1C levels", - "NCTID": "NCT01798420" - }, - { - "brief_title": "Effect of a 10,000 EU Dose of Endotoxin in Allergic and Mildly Asthmatic Adults", - "phase": "Phase 1", - "drugs": "['Clinical Center Reference Endotoxin (CCRE)']", - "drugs_list": [ - "Clinical Center Reference Endotoxin (CCRE)" - ], - "diseases": "['Rhinitis, Allergic, Perennial', 'Rhinitis, Allergic, Seasonal', 'Asthma']", - "diseases_list": [ - "Rhinitis", - "Allergic", - "Perennial", - "Rhinitis", - "Allergic", - "Seasonal", - "Asthma" - ], - "enrollment": "11.0", - "inclusion_criteria": "inclusion criteria: \n\n inclusion criteria \n\n Specific allergy to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response. \n\n FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .75 (without use of bronchodilating medications for 12 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma. \n\n History of nasal allergy, including episodic, perennial, or seasonal sneezing, nasal congestion or cough, or such symptoms associated with specific exposures (such as cat or dog) \n\n Criteria for classification as having asthma with allergic rhinitis vs. allergic rhinitis alone: \n\n History of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician diagnosed asthma. \n\n Provocative concentration of methacholine producing a 20% fall in FEV1 (PC20 methacholine) of less than 10 mg/ml by the method used (see below). \n\n ", - "exclusion_criteria": ": \n\n Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, or chronic thyroid disease. \n\n Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months. \n\n Use of systemic steroid therapy within the preceding 12 months for an asthma exacerbation. All use of systemic steroids in the last year will be reviewed by a study physician. \n\n Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or zafirkulast) initiated within the past month (except for use of cromolyn exclusively prior to exercise). Patients must be on a stable regimen of therapy and shown to be stable. \n\n Use of daily theophylline within the past month. \n\n Pregnancy or nursing a baby. \n\n Cigarette smoking > 1 pack per month. \n\n Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. \n\n Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. \n\n Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to include prophylactic use of albuterol prior to exercise). \n\n Dosing level of an inhaled steroid must be consistent with mild episodic asthma as outlined by the NHLBI NAEPP guidelines. Any dose of inhaled steroid typically used for moderate or severe asthma will result in exclusion from the protocol. \n\n Viral upper respiratory tract infection within 2 weeks of challenge. \n\n Any acute infection requiring antibiotics within 2 weeks of challenge.", - "brief_summary": "The purposes of this pilot safety study are to identify a dose of inhaled Clinical Center Reference Endotoxin (CCRE) that is well tolerated by allergic subjects that induces measurable increases in neutrophil content of induced sputum that can be employed to screen large populations for susceptibility to the inflammatory effect of inhaled endotoxin.", - "NCTID": "NCT00839189" - }, - { - "brief_title": "Comparison Between Levofloxacin and Prulifloxacin, in Internal Medicine Patients With Acute Exacerbation of COPD", - "phase": "Phase 4", - "drugs": "['Levofloxacin 1 tablet 500 mg once a day', 'Prulifloxacin 1 tablet 600 mg once a day']", - "drugs_list": [ - "Levofloxacin 1 tablet 500 mg once a day", - "Prulifloxacin 1 tablet 600 mg once a day" - ], - "diseases": "['COPD Exacerbation']", - "diseases_list": [ - "COPD Exacerbation" - ], - "enrollment": "258.0", - "inclusion_criteria": "inclusion criteria: \n\n - Presence of purulent sputum documented by colorimetric assay (Allegra et al., Resp Med 2005), plus at least two of the following signs-symptoms \n\n Increased cough \n\n Increased dyspnea \n\n Increase in sputum volume appeared at least 3 days \n\n previous antibiotic treatment with any medication (eg, amoxicillin, amoxicillin / clavulanate, cephalosporins or macrolides) with the exception of quinolones, conducted for at least 3 days with persistence or worsening of symptoms and subsequent use of hospital \n\n \u2265 60 years \n\n FEV1 <80% and \u2265 30% and ratio FEV 1 / FVC <70% \n\n chest x-ray negative for inflammatory infiltrates \n\n informed consent \n\n ", - "exclusion_criteria": ": \n\n asthma \n\n pulmonary neoplasms \n\n a history of allergy or hypersensitivity to quinolones \n\n impracticability in oral antibiotic and / or altered ability to absorption by the gastrointestinal system \n\n a history of epilepsy, seizures, cerebral vascular disease (stroke cerebri within 6 months) \n\n history of tendinopathy \n\n note or severe renal impairment creatinine> than twice the upper limit of the normal range or hepatic impairment (AST and / or ALT> twice the upper limit of the normal range) \n\n patients with sepsis, tuberculosis or other infections in other organs or systems \n\n cystic fibrosis \n\n patients with inherited tolerance to intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, or deficiency of the enzyme glucose-6-phosphate dehydrogenase \n\n pregnant or breastfeeding \n\n drug or alcohol addiction \n\n experimental concomitant treatment with other drugs", - "brief_summary": "The primary objective of the study is to determine the percentage of patients with therapeutic success at the end of the cycle of antibiotic therapy (10 days), in the two treatment groups (levofloxacin and prulifloxacin). The effect of study treatments will be evaluated on the basis of a score determined in relation to the signs-symptoms of acute exacerbation of COPD (sputum purulence, sputum volume, cough, dyspnea, fever)", - "NCTID": "NCT01710488" - }, - { - "brief_title": "The Oral Microbiota as Reservoir for Systemic Opportunistic Pathogens", - "phase": "", - "drugs": "['Dental cleaning']", - "drugs_list": [ - "Dental cleaning" - ], - "diseases": "['COPD Exacerbation', 'Pulmonary Disease, Chronic Obstructive', 'Dental Plaque']", - "diseases_list": [ - "COPD Exacerbation", - "Pulmonary Disease", - "Chronic Obstructive", - "Dental Plaque" - ], - "enrollment": "101.0", - "inclusion_criteria": "inclusion criteria: \n\n COPD arm - COPD Gold standard 1-4. \n\n ", - "exclusion_criteria": ": \n\n Physically unable to make it to the dental clinic.", - "brief_summary": "Small pilot studies with approximately 20 people per group support that eradication of the oral flora causes fewer exacerbations in chronic obstructive pulmonary disease (COPD) patients. The biological underpinning put forward is that eradicating the oral microbiome will eliminate a source of re-infection as the concentration of antibiotics prescribed to treat COPD exacerbations are not able to inhibit the bacteria in the oral biofilms that require 250 times higher concentration.~The specific aim is to investigate if adding advanced dental cleaning to COPD treatment can (i) lower the number of exacerbations and (ii) improve the COPD symptoms the coming 12 months. In an effort to explain the underpinning mechanism we will collect oral dental biofilm samples at baseline and follow up in the treatment and control group to investigate changes in the composition of the biofilm.~The subjects are selected by experienced COPD nurses. Exclusion criteria are having metastatic cancer or dementia. The COPD clinic informs the dental personal about COPD parameters, including spirometry data. At the dental clinic the patient answers a questionnaire, including a COPD assessment test (CAT) which has been validated extensively. The patients undergo a dental examination and are then randomized to test or control group. The test group go through supra- and subgingival scaling and scraping of the tongue as well as chlorhexidine rinse. The control group attends all visits.~All subjects go through the intervention after 6 months and are followed up after 12 and 24 months using questionnaire, dental plaque sampling and spirometry. The COPD nurses reviewing their medical records assess number of exacerbations.~A confirmation of the study hypothesis will be important in lowering the number of exacerbations in COPD patients, causing less suffering, less costs and less usage of antibiotics. If dental treatment is beneficial for exacerbation frequency it could be argued that dental treatment should be subsidized in this patient category.", - "NCTID": "NCT02619903" - }, - { - "brief_title": "Predictor for an Additional Benefit of Inhaled Corticosteroid in Patients Treated With Tiotropium for COPD", - "phase": "Phase 4", - "drugs": "['Budesonide']", - "drugs_list": [ - "Budesonide" - ], - "diseases": "['COPD']", - "diseases_list": [ - "COPD" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria: \n\n FEV1/FVC < 70% \n\n FEV1 % predicted > 60% \n\n ", - "exclusion_criteria": ": \n\n Other major disease \n\n Asthma \n\n Currently taking inhaled corticosteroids \n\n oral corticosteroids in the last 3 month \n\n significant cardiovascular disease \n\n pregnancy/breast feeding \n\n current use of salmeterol or other long acting bronchodilator", - "brief_summary": "Study purpose is to evaluate if subjects with chronic obstructive pulmonary disease (COPD) are more likely to be responsive to additional inhaled corticosteroids if they have a positive response to hyperosmolar challenge with mannitol than if their response is negative.", - "NCTID": "NCT00860938" - } - ], - "2": [ - { - "brief_title": "Treatment in Patients Hospitalized With Acute Exacerbation of Chronic Obstructive Pulmonary Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "400.0", - "inclusion_criteria": "inclusion criteria: \n\n Hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease \n\n Age\u2265 40years old \n\n ", - "exclusion_criteria": ": \n\n The first diagnosis which caused hospitalization is not acute exacerbation of chronic obstructive pulmonary disease \n\n Chest radiography shows congestive heart failure \n\n Chest CT shows lung cancer, active pulmonary tuberculosis, pulmonary thromboembolism or interstitial lung diseases \n\n Serious cardiac failure, renal insufficiency or hepatic dysfunction", - "brief_summary": "Chronic obstructive pulmonary disease has become a serious global health care and public health problems due to its high prevalence, high morbidity and heavy economic burden. Acute exacerbation of chronic obstructive pulmonary disease is one of the most important causes of death in patients with COPD. Systemic corticosteroids therapy is recommended in COPD exacerbations. In clinical practice for the treatment of acute exacerbation of COPD\uff0c antibiotic application is still controversial. Evidence from current guideline is based on strict criteria from randomized controlled trials, thus the given condition is simplified. Patients meet the criteria account for the minority in the real world. Therefore, it is still not clear whether most patients benefit from the recommended treatment. In our design, hospitalized patients with acute exacerbation of COPD will be enrolled, with their treatment, arterial hypoxemia, recovery time and length of hospitalization being observed. The main purpose is to evaluate the benefit effect of current recommended treatment of acute exacerbation of COPD in the real world.", - "NCTID": "NCT02219360" - }, - { - "brief_title": "ANTEAB: a Study of Early Antibiotherapy in the ICU Management of Acute Exacerbations of COPD", - "phase": "Phase 4", - "drugs": "['Amoxicillin-clavulanic']", - "drugs_list": [ - "Amoxicillin-clavulanic" - ], - "diseases": "['Chronic Obstructive Lung Disease (COLD)']", - "diseases_list": [ - "Chronic Obstructive Lung Disease (COLD)" - ], - "enrollment": "520.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients included are those with documented or suspected COLD, exclusive of other bronchial or lung disease, and admitted for acute exacerbation, in the absence of overt sepsis or broncho-pneumonia, and having no other organ. \n\n ", - "exclusion_criteria": ": \n\n Patients recently hospitalised, having received antibiotics since more than 24h, or on long-term steroids will not be included", - "brief_summary": "Intensive Care Unit (ICU) admission for acute exacerbation of chronic obstructive lung disease (COLD) is a major cause of morbidity and mortality in such patients. Although bacterial of mortality in such patients. Although bacterial and or viral infections are considered as the major precipitating factor, the antibiotic strategy in this setting is unclear. The absence of overt infection remains controversial, and has not been adequately studied in patients admitted to the ICU. To assess the benefit ( or lack thereof ) of routine early systemic antibiotic therapy in patients with COLD admitted to the ICU.~The primary objective of the essay is to evaluate the effectiveness of the precocious antibiotic therapy on the length of the respiratory symptoms with the admitted patients in polyvalent medical intensive care of chronic obstructive lung disease ( COLD )", - "NCTID": "NCT00190437" - }, - { - "brief_title": "Prevalence of Malignant and Premalignant Lesions in the Head & Neck in Patients With Chronic Obstructive Pulmonary Disease", - "phase": "", - "drugs": "['Stroboscopic nasopharyngeal laryngoscopy', 'Stroboscopic nasopharyngeal laryngoscopy', 'Stroboscopic nasopharyngeal laryngoscopy']", - "drugs_list": [ - "Stroboscopic nasopharyngeal laryngoscopy", - "Stroboscopic nasopharyngeal laryngoscopy", - "Stroboscopic nasopharyngeal laryngoscopy" - ], - "diseases": "['COPD, HEAD&NECK CANCER,SCREENING']", - "diseases_list": [ - "COPD", - "HEAD&NECK CANCER,SCREENING" - ], - "enrollment": "250.0", - "inclusion_criteria": "inclusion criteria: \n\n group of adult COPD patients. \n\n Adult patients with smoking history and no clinical manifestation of COPD who will be recruited form the institute of pulmonary medicine and the otolaryngology outpatient clinic. \n\n Adult patients with lung disease unrelated to smoking, i.e. bronchial asthma who will be recruited from the institute of pulmonary medicine \n\n ", - "exclusion_criteria": ": \n\n Patients with an acute disease or COPD exacerbation \n\n Pregnant patients \n\n Patients who were intubated \u22643 months prior to inclusion \n\n Patients with a medical history of surgical intervention in the upper airway \n\n Patients with a medical history of malignant disease in the upper airway \n\n Patients who underwent radiotherapy of head and neck", - "brief_summary": "Head and neck cancers usually occur in patients who have a history of long tobacco use. Chronic obstructive pulmonary disease (COPD) is a chronic progressive disease of the airways and lung parenchyma that is also associated with exposure to tobacco. COPD and head & neck cancer share a common environmental risk factor in cigarette smoke exposure. the investigators hypothesize that patients with chronic lung disease related to smoking have a higher risk to develop cancer in the head and neck.~The investigators designed a study to assess the prevalence of cancer and pre-cancer disease in the head & neck in patients with chronic lung disease. the investigators will examine patients with and without a history of smoking and chronic lung disease in order to determine the prevalence of head and neck cancer in the different groups. The patients who will be included in the study will undergo comprehensive evaluation of their lung function and voice performance.~This study is a joint effort of the Pulmonology Institute and the Department of Otolaryngology, Head & Neck Surgery in Israel and the Netherlands.", - "NCTID": "NCT02333812" - }, - { - "brief_title": "MISSION COPD - Modern Innovative SolutionS in Improving Outcomes iN COPD", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "114.0", - "inclusion_criteria": "inclusion criteria - Patients: \n\n Male of Female, aged 18 years or above. \n\n Attended the MISSION clinic as a patient. \n\n Participant is willing and able to give informed consent for participation in the study. \n\n ", - "exclusion_criteria": " - Patients: \n\n - The patient is unable or unwilling to give consent \n\n inclusion criteria - Health Care Professionals \n\n Male or Female, aged 18 or above. \n\n Attended the MISSION clinic as a health care professional \n\n Participant is willing and able to give informed consent for participation in the study. \n\n ", - "brief_summary": "MISSION is a new and novel way of delivering highly specialised Chronic Obstructive Pulmonary Disease (COPD) care and has the potential to change the way COPD care across the UK is delivered as well as services for other long term health conditions. The MISSION model has been piloted in asthma which is the subject of an ongoing research study. This is the first model of this type in COPD and the current research study aims to evaluate the outcomes of the project. This will be done in several different ways. The study is a mixed methods evaluation of the new service comparing outcomes before and after the clinic using retrospective data analysis and prospective qualitative interview. The study will be conducted at Portsmouth Hospitals NHS Trust and will recruit patients who attend MISSION COPD clinics as well as staff who attended MISSION clinics in a professional capacity.", - "NCTID": "NCT02534766" - }, - { - "brief_title": "The Role of Nebulized Budesonide in the Treatment of Acute Exacerbations of COPD", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['COPD Acute Exacerbation']", - "diseases_list": [ - "COPD Acute Exacerbation" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n COPD patients who were admitted to our pulmonary department for an acute exacerbation were prospectively enrolled in the study \n\n ", - "exclusion_criteria": ": \n\n COPD patients hospitalized with specific reasons like pneumonia, pulmonary emboli, congestive heart failure, pneumothorax etc. as the cause of acute exacerbation, or patients with risk of imminent respiratory failure requiring mechanical ventilation or direct admission to the ICU were excluded.", - "brief_summary": "This study was designed to evaluate the hypothesis that nebulized budesonide) might be an alternative to systemic corticosteroids (SC) in the treatment of patients with acute exacerbations of COPD (AECOPD).", - "NCTID": "NCT00274222" - }, - { - "brief_title": "Study on COPD Corticosteroid-induced Hyperglycemia on Clinical Outcome in Patients With COPD", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['COPD']", - "diseases_list": [ - "COPD" - ], - "enrollment": "450.0", - "inclusion_criteria": "inclusion criteria: Patients admitted with COPD exacerbation", - "exclusion_criteria": "", - "brief_summary": "Hyperglycemia is a common complication of corticosteroid (cortisone) therapy. It is estimated that more than a third of patients with chronic pulmonary disease (COPD) exacerbation (16). Despite its frequency, the impact of corticosteroid-induced diabetes on clinical outcome and mortality is not known. A computerized search of biomedical journal literature from MEDLINE, PubMed, and Ovid from 1966 to 2006 provided very little information on the prevalence and outcome of corticosteroid-induced diabetes in patients with COPD. Therefore, the present study aims to evaluate the impact of corticosteroid-induced diabetes on clinical outcome in patients with COPD exacerbation. We will perform a retrospective chart review of all patients admitted to the hospital with COPD exacerbation from 1/01/05 to 06/30/06 at Grady Memorial Hospital. Medical records of all patients with COPD exacerbation treated with corticosteroids will be analyzed. Data on demographics, laboratory values, mortality rate, rate of hypoglycemic events, length of stay, as well as disposition at discharge will be analyzed.", - "NCTID": "NCT00605007" - }, - { - "brief_title": "Investigation on the Role of Corticosteroids and Beta-Agonists on Cytokine Production in COPD Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['COPD']", - "diseases_list": [ - "COPD" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria: \n\n clinical COPD \n\n smoking \n\n age > 40 years \n\n ", - "exclusion_criteria": ": \n\n age < 40 years \n\n use of antibiotics, corticosteroids or beta-agonists", - "brief_summary": "Research on the synergistic effect of corticosteroids and beta-agonists on the cytokine production in COPD patients. Blood will be obtained from healthy volunteers and COPD patients and blood monocytes will be stimulated to produce cytokines with or without the prementioned drugs.", - "NCTID": "NCT00263380" - } - ] - }, - { - "patient_id": "sigir-201424", - "patient": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", - "0": [ - { - "brief_title": "Prospective Evaluation of Spleen Injury Treatments in Languedoc Roussillon", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Trauma']", - "diseases_list": [ - "Trauma" - ], - "enrollment": "93.0", - "inclusion_criteria": "inclusion criteria: \n\n Hospitalized for abdominal trauma \n\n diagnosis of splenic contusion confirmed by scanner or during surgery for hemodynamically unstable cases \n\n patient has signed a consent form \n\n patient is a beneficiary of or affiliated with a social security program \n\n ", - "exclusion_criteria": ": \n\n Refuses to participate \n\n Pregnant or breastfeeding \n\n Patient under guardianship", - "brief_summary": "Descriptive, prospective, multicenter evaluation of spleen injury treatment in the Languedoc Roussilon region according to trauma severity, morbi-mortality and length of hospitalization.", - "NCTID": "NCT01103999" - }, - { - "brief_title": "Splenic Function After Spleen-Preserving Distal Pancreatectomy With Excision of Splenic Artery and Vein", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Overwhelming Post-Splenectomy Infection']", - "diseases_list": [ - "Overwhelming Post-Splenectomy Infection" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n all patients received splenectomy (patient list will be applied from Dept. of Pathology) at National Taiwan University Hospital in the last 20 years. \n\n ", - "exclusion_criteria": ": \n\n who rejected interview.", - "brief_summary": "The spleen may be removed due to benign hematologic disorders, such as idiopathic thrombocytopenic purpura and hereditary spherocytosis, or malignancies, such as lymphomas and leukemias. Splenectomy may also be performed due to splenic traumas or in association of some surgical procedures, when combined splenectomy will make the operations easier. The most well known procedure is distal pancreatectomy combined with splenectomy.~In this research, there are two main goals. Firstly, establish the data about the incidence of overwhelming postsplenectomy infection (OPSI) in our country. Currently, the western data of the incidence, morbidity rate and mortality rate of OPSI is well established and vaccination along with prophylactic antibiotics is strongly recommended. Since the incidence of OPSI in our country isn't clear, most (>95%) splenectomized patients in our hospital (National Taiwan University Hospital) did not have vaccination or prophylactic antibiotics. We'll try to determine the incidence of OPSI by reviewing of our hospital charts and by structured interviews with patients.~The spleen is a phagocytic filter. So asplenic patients have higher risks of getting infection and some spleen-preserving procedures are proposed. In our initial experiences, distal pancreatectomy with splenic artery and vein divided could be safely performed and greatly increased the possibility of preservation of spleen. However, when the spleen was preserved with dividing the splenic artery and vein, the blood supply to the spleen will be shifted from splenic artery to short gastric artery. Although a substantial immunologic advantage exists if splenic tissue remains, this may not offer sufficient protection from encapsulated bacteria if splenic arterial blood flow is reduced because experimental animal studies have demonstrated that an intact splenic arterial system is necessary for optimal control of infection. Thus, although the spleen is preserved in above mentioned procedure, the function of the preserved spleen is questionable and has never been studied of. Our second object is to determine the splenic function after after spleen-preserving distal pancreatectomy with excision of splenic artery and vein by comparison of abdominal computed tomography and immunological function of patients before and after operation. Besides, we'll designed an animal experiment to examine the rate of pneumococcal clearance by the spleen and to determine the relationship between splenic blood flow and splenic tissue mass in bacterial clearance from the blood when the splenic vessels were divided.", - "NCTID": "NCT00778362" - }, - { - "brief_title": "Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients", - "phase": "", - "drugs": "['Seprafilm']", - "drugs_list": [ - "Seprafilm" - ], - "diseases": "['Open Abdomen', 'Abdominal Adhesions', 'Trauma', 'Wounds and Injury']", - "diseases_list": [ - "Open Abdomen", - "Abdominal Adhesions", - "Trauma", - "Wounds and Injury" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Trauma patients undergoing DC/OA management for traumatic injury \n\n Age 18+ \n\n Life expectancy longer than 48 hours \n\n ", - "exclusion_criteria": ": \n\n Prisoners \n\n Pregnant patients \n\n Younger than 18 years of age", - "brief_summary": "The goal of this study is to test the effects of Seprafilm adhesion barrier on patients who are undergoing open abdomen damage control management for traumatic injuries when compared to no adhesion barrier use. Specifically, the researchers wish to study the effects of Seprafilm adhesion barrier on:~the number and intensity of adhesions,~whether there is any difference between treatment groups (Seprafilm vs. no Seprafilm) who go on to successful definitive abdominal closure,~rate of occurrence of secondary complications (such as abscesses) associated with short- and long-term beneficial effects of reducing adhesion formation,and~whether there is any difference between treatment groups regarding patient functional recovery.", - "NCTID": "NCT01594385" - }, - { - "brief_title": "Distal Pancreatectomy With Partial Splenectomy for Pancreatic Tumors", - "phase": "", - "drugs": "['Distal pancreatectomy with partial splenectomy']", - "drugs_list": [ - "Distal pancreatectomy with partial splenectomy" - ], - "diseases": "['Tumor of Exocrine Pancreas']", - "diseases_list": [ - "Tumor of Exocrine Pancreas" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with solid or cystic neoplasms of the pancreas who are being considered for distal pancreatectomy/splenectomy to be performed in either an open, laparoscopic, of da Vinci assisted fashion. \n\n No evidence of metastatic disease \n\n No evidence of local invasion into surrounding organs \n\n ECOG performance status <3 \n\n Age 18 years or greater \n\n Participants will provide written informed consent to be part of the study \n\n ", - "exclusion_criteria": ": \n\n Age less than 18 years old \n\n Women who are pregnant \n\n Known hereditary bleeding disorder with history of post-operative hemorrhage \n\n Patients maintained on chronic anticoagulation (eg Coumadin therapy) \n\n Known hematogenous disorder \n\n Previous gastric fundoplication procedure or any procedure which interrupts the short gastric blood supply to the spleen \n\n Known primary or secondary malignancy of the spleen \n\n Pancreatic tumors which invade surrounding structures \n\n Prisoners \n\n Patients with impaired decision-making skills", - "brief_summary": "Most resectable tumors arising in the body or tail of the pancreas are malignancies or premalignancies which are surgically treated with distal pancreatectomy in combination with splenectomy. Retrieval of the lymph node tissue which lies along the splenic vessels is necessary to complete an oncologically sound operation. Two techniques for spleen preserving distal pancreatectomy have been described, but only a small number of lesions are amenable to spleen preserving pancreas surgery because these operation compromise oncologic principles. Removal of a normal spleen usually does not cause immediate consequences but can make patients vulnerable to life threatening infections. Asplenic patients must be vigilant for these infections and antibiotic prophylaxis is recommended anytime a fever occurs. Splenectomy results in measurable changes in the cellular components of the blood. If thrombocytosis occurs as a result of splenectomy, it requires life-long antiplatelet treatment.~Some childhood hematologic disorders such as hereditary spherocytosis are successfully treated with partial splenectomy. The post-surgical remnant spleen has been shown to be viable and functional. Both hematologic and immunologic function of the spleen seems to be preserved in most patients. Partial splenectomy has also been successful ly employed to treat benign and malignant lesions of the spleen. Unfortunately these indications for surgery are rare and so the experience with partial splenectomy is small.~To date, distal pancreatectomy with partial splenectomy has not been described in the medical literature. The investigators have devised a surgical procedure combining distal pancreatectomy with partial splenectomy, in principal allowing preservation of splenic function without compromise of oncologic principles. This procedure is possible now because of new technology which allows for near bloodless transection of solid organs. These instruments are routinely used in liver, kidney and pancreas surgery. There are scattered reports of successful use of these instruments in splenic transection, but there is no large experience to date.~The study intends to answer the question, is the proposed procedure, distal pancreatectomy and partial splenectomy, a viable alternative to the current standard of care, distal pancreatectomy with total splenectomy, for patients who will undergo surgical treatment of pancreas lesions arising in the body or tail of the pancreas?", - "NCTID": "NCT01412684" - }, - { - "brief_title": "T.E.A. Study Three Days Ertapenem Versus Three Days Ampicillin- Sulbactam", - "phase": "Phase 4", - "drugs": "['Ertapenem', 'Ampicillin-Sulbactam']", - "drugs_list": [ - "Ertapenem", - "Ampicillin-Sulbactam" - ], - "diseases": "['Intra-Abdominal Infection']", - "diseases_list": [ - "Intra-Abdominal Infection" - ], - "enrollment": "142.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult patients ( > 18 years) requiring surgical intervention within 24 hours of diagnosis, for localized IAI infections (i.e extending beyond the organ wall but confined near the hollow viscus, mild to moderate in severity): \n\n Acute appendicitis: Ruptured or perforated with abscess \n\n Acute diverticulitis with perforation and/or abscess \n\n Acute cholecystitis (including gangrenous) with either rupture or perforation \n\n Acute gastric and duodenal ( > 24 hours) perforation \n\n Traumatic (> 12 hours) perforation of the intestines \n\n Secondary peritonitis due to perforated viscus \n\n Intra-abdominal abscess (including of liver and spleen) \n\n ", - "exclusion_criteria": ": \n\n Traumatic bowel perforation requiring surgery within 12 hours \n\n Perforation of gastroduodenal ulcers requiring surgery within 24 hours \n\n other intra-abdominal processes in which the primary etiology was unlikely to be infectious. \n\n Patients lactating or pregnant \n\n Patients with a history of allergy, hypersensitivity, or any severe reaction to the study antibiotics \n\n Patients with rapidly progressive or terminal illness; \n\n Patients with a history or presence of severe hepatic or renal disease (e.g. creatinine clearance < 0.5 ml/min/1.73 m2); \n\n Patients with a concomitant infection that would interfere with evaluation of response to the study antibiotics.", - "brief_summary": "The aim of the study was to compare the activity (efficacy and safety) of Ertapenem administered according to a short treatment for three days versus a short treatment for three days with AS in patients with an community acquired IAI of mild to moderate severity.", - "NCTID": "NCT00630513" - }, - { - "brief_title": "Comparison Between Open and Laparoscopic Splenic Aneurysms Repair", - "phase": "Phase 3", - "drugs": "['Laparoscopic splenic aneurysm repair, eventual splenectomy', 'Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy']", - "drugs_list": [ - "Laparoscopic splenic aneurysm repair", - "eventual splenectomy", - "Laparotomic splenic artery aneurysm repair", - "eventual artery reconstruction or splenectomy" - ], - "diseases": "['Splenic Artery Aneurysm']", - "diseases_list": [ - "Splenic Artery Aneurysm" - ], - "enrollment": "29.0", - "inclusion_criteria": "inclusion criteria: \n\n Splenic artery aneurysm with diameter greater than 2 cm \n\n Splenic artery aneurysm with diameter smaller than 2 cm if risk factors for rupture are associated (child bearing age, pregnancy, blister or saccular shape, increasing diameter) \n\n ", - "exclusion_criteria": ": \n\n Complex aneurysm involving the celiac trunk \n\n American Society of Anesthesiologists (ASA) Score > 3", - "brief_summary": "The purpose of this study is compare two different surgical treatments of splenic artery aneurysms: open and laparoscopic approach.", - "NCTID": "NCT01387828" - }, - { - "brief_title": "Analysis of Risk Factors for Death After Blunt Traumatic Rupture of the Thoracic Aorta", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Aortic Rupture']", - "diseases_list": [ - "Aortic Rupture" - ], - "enrollment": "85.0", - "inclusion_criteria": "inclusion criteria: \n\n During the study period of 14 years (January 1990 to December 2003), all consecutive cases with traumatic rupture of the thoracic aorta being reported in the greater area of Zurich with about one million inhabitants were included in the present study \n\n ", - "exclusion_criteria": ": \n\n Non-traumatic aortic rupture \n\n Non-traumatic aortic dissection", - "brief_summary": "Aortic injuries after blunt thoracic trauma are compared to the great incidence of accidents relatively rare, but potentially serious leading to death at scene in most of the cases. The study was undertaken to delineate mortality and its risk factors on three different levels (pre-hospital, in-hospital and overall). Between 1990 and 2003, all consecutive patients and victims with traumatic aortic rupture were retrospectively analyzed by reviewing hospital and autopsy records.", - "NCTID": "NCT01632774" - }, - { - "brief_title": "Pelvic CT Imaging in Blunt Abdominal Trauma", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Blunt Abdominal Trauma']", - "diseases_list": [ - "Blunt Abdominal Trauma" - ], - "enrollment": "230.0", - "inclusion_criteria": "inclusion criteria: \n\n 3-60 years of age evaluated for blunt trauma with a GCS of >14 \n\n Order of CT abdomen and pelvis imaging \n\n ", - "exclusion_criteria": ": \n\n Patients requiring intubation or suspected neurological injury (defined above) \n\n Pregnant patients \n\n Intoxicated patients \n\n Patients with age defined hypotension \n\n Exploratory laparotomy or transfusion during the ED evaluation \n\n Non-verbal patients \n\n Positive FAST exam \n\n Patients with abdominal trauma or surgery in the last month \n\n Victims of sexual assault or non-accidental trauma (NAT) \n\n Patients with known or suspected fractures of the femur or pelvis prior to CT imaging \n\n Patients with hip dislocations", - "brief_summary": "Abdominopelvic CT (CTap) utilization rose significantly in blunt trauma patients over the last decade. However, the observed increases failed to reduce mortality or missed injury rates. Several investigators have derived (citation) and validated (citation) clinical decision rules that attempt to identify a subset of low risk pediatric and adult patients in whom abdominopelvic CT imaging can be safely eliminated. Thus far these efforts failed to significantly reduce utilization. The investigators propose an alternative and complimentary strategy to decrease radiation by selectively eliminating the pelvic imaging portion of the abdominopelvic CT in low risk patients. In stable, alert patients without clinically evidence of pelvis or hip fractures, abdominal CT imaging alone (diaphragm to iliac crest) identifies clinically significant intra-abdominal injury (cs-IAI) as accurately as routine abdominopelvic imaging (diaphragm to greater trochanter) and results in a clinically important decrease in radiation exposure. The study will investigate this by comparing the accuracy of an imaging protocol using CT abdomen alone versus CT abdomen and pelvis to detect cs-IAI among stable, blunt trauma patients without suspected pelvis or hip fractures in two age groups: ages 3-17 years and 18-60. Patients will undergo CT imaging as deemed clinically indicated by the treating clinician. Among those who have abdominopelvic CT scans, the study will determine the test characteristics of CT abdomen alone versus CT abdomen plus CT pelvis imaging for the identification of cs-IAI. The reference standard will include initial radiology reports, with structured follow up of indeterminate scans, operative reports, and 7-day medical record review.", - "NCTID": "NCT01828749" - }, - { - "brief_title": "Anticoagulation Post Laparoscopic Splenectomy", - "phase": "Phase 2", - "drugs": "['Enoxaparin']", - "drugs_list": [ - "Enoxaparin" - ], - "diseases": "['Portal Vein Thrombosis', 'Splenic Vein Thrombosis']", - "diseases_list": [ - "Portal Vein Thrombosis", - "Splenic Vein Thrombosis" - ], - "enrollment": "35.0", - "inclusion_criteria": "inclusion criteria: \n\n Scheduled to undergo laparoscopic splenectomy at The University of Alberta or Grey Nun's Community Hospitals \n\n Capable of understanding the purpose and risks of the study and willing/able to sign a statement of informed consent \n\n Willing to undergo daily subcutaneous injections of Lovenox\u00ae \n\n ", - "exclusion_criteria": ": \n\n Pregnant or nursing \n\n Unable or unwilling to provide informed consent \n\n Bleeding diathesis or currently on anticoagulation therapy (i.e. coumadin, heparin, LMWH) \n\n Hemorrhagic cerebral vascular accident \n\n Severe uncontrolled hypertension \n\n Diabetic or hemorrhagic retinopathy \n\n Contradictions to anticoagulation (i.e. active GI bleed, gastric or duodenal ulcer, sustained platelet count < 50 x103/uL, splenectomy due to trauma or history of heparin induced thrombocytopenia) \n\n Conversion to open splenectomy \n\n Allergy to Lovenox\u00ae, heparin, or other low molecular weight heparins \n\n Bacterial endocarditis", - "brief_summary": "Splenic/portal vein thrombosis is an alarming complication of splenectomy. Retrospective studies in the literature have shown the incidence of symptomatic splenic/portal vein thrombosis to be between 0.7% (Rattner et al., 1993) to 8% (Winslow et al., 2002). This is a single-center, prospective, randomized study in subjects undergoing laparoscopic splenectomy. All participants will receive one dose of pre-operative low molecular weight heparin (Lovenox\u00ae) subcutaneously, 2 hours prior to surgery. Participants will be randomized pre-operatively to treatment or control group however the treatment allocation will not be revealed until the surgery is complete. Postoperatively, those assigned to the treatment group will receive 40 mg of Lovenox\u00ae subcutaneously once a day for 21 days; those in the control group will not. Patients with severe renal impairment will receive an adjusted dose of Lovenox\u00ae (30 mg subcutaneous dose daily). All patients will have a baseline abdominal Doppler ultrasound preoperatively and a second one done at 14 to 28 days post surgery to monitor for the presence of portal vein and/or splenic vein thrombosis. They will also have their lipase and liver function tests checked to correlate with the imaging findings.", - "NCTID": "NCT00769873" - }, - { - "brief_title": "Computer Tomography (CT) Trial of Acute Abdomen", - "phase": "", - "drugs": "['Abdominal contrast-enhanced CT scanning']", - "drugs_list": [ - "Abdominal contrast-enhanced CT scanning" - ], - "diseases": "['Acute Abdomen']", - "diseases_list": [ - "Acute Abdomen" - ], - "enrollment": "250.0", - "inclusion_criteria": "inclusion criteria: \n\n age > 18 \n\n abdominal pain > 2h and < 7 days \n\n ", - "exclusion_criteria": ": \n\n pregnancy \n\n acute abdominal trauma \n\n allergy to iodinated contrast media \n\n severe renal insufficiency \n\n metformin medication combined with elevated plasma creatinin level \n\n lack of cooperation (if informed consent is not possible) \n\n abdominal pain combined with bleeding shock", - "brief_summary": "The purpose of this study is to determine the impact of routinely performed early CT scanning in terms of diagnostic accuracy, patient management and cost-effectiveness compared to current imaging practice in patients suffering from acute abdomen.", - "NCTID": "NCT00870766" - }, - { - "brief_title": "Emergency Management of Minor Blunt Thoracic Trauma", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Thoracic Injuries,']", - "diseases_list": [ - "Thoracic Injuries," - ], - "enrollment": "186.0", - "inclusion_criteria": "inclusion criteria: \n\n Glasgow Coma Scale (GCS) of 15 \n\n stable vital signs \n\n admitted within the first 6 hours after injury \n\n ", - "exclusion_criteria": ": \n\n urgent and urgent triage category", - "brief_summary": "Thoracic traumas are frequent causes of emergency department admissions and the third most common cause of death from trauma. Although emergency management of major thoracic traumas that have high mortality and morbidity were discussed and well-understood in detail in the literature, there are limited information regarding diagnosis, emergency management, treatment and follow-up after discharge of patients with minor blunt thoracic traumas.~The investigators aimed to investigate demographic data, physical examination findings, and the relationship between lung injury, emergency department final diagnosis, hospitalization, discharge and re-admission rates, effects of prescribed analgesics on pain and re-admissions of patients with a pre-diagnosis of minor blunt thoracic trauma on first admission.", - "NCTID": "NCT02494232" - }, - { - "brief_title": "The Alteration of Macrophage Function in the Spleen Tissues From Patients With Primary Immune Thrombocytopenia", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Immune Thrombocytopenia']", - "diseases_list": [ - "Immune Thrombocytopenia" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n adult ITP patients whose platelet counts remain less than 10 x 10^9/L \n\n patients whose platelet counts remain less than 30 x 10^9/L and who continue to experience excessive bleeding after 4 to 6 weeks of appropriate medical treatment \n\n patients who have experienced a transient response to primary treatment and have platelet counts less than 30 x 10^9/L after 3 months \n\n require continuous glucocorticoid therapy to maintain safe platelet counts \n\n Willing and able to sign written informed consent. \n\n ", - "exclusion_criteria": ": \n\n Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit. \n\n Current HIV infection or hepatitis B virus or hepatitis C virus infections. \n\n Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) \n\n Female patients who are pregnant. \n\n Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test. \n\n Patients who are deemed unsuitable for the study by the investigator.", - "brief_summary": "This project was undertaken by Qilu Hospital of Shandong University and other well-known hospitals in China. In order to report the alteration on the macrophage function in the spleen tissue of primary immune thrombocytopenia (ITP).", - "NCTID": "NCT01869049" - }, - { - "brief_title": "TRACT Study: Evaluation of the Value of Routine Thoraco-abdominal CT in Blunt Trauma Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Abdominal Injuries', 'Thoracic Injuries']", - "diseases_list": [ - "Abdominal Injuries", - "Thoracic Injuries" - ], - "enrollment": "1000.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with life threatening vital problems: respiratory, circulatory (pulse > 120/min, blood pressure < 100 mmHg, refill > 4 sec, exterior blood loss > 500 ml) or neurologically (Glasgow Coma Score < 14, abnormal pupils) compromised patients. \n\n Patients with a revised trauma score under 12 \n\n Patients with signs of fractures from at least two long bones \n\n Patients with clinical signs of flail chest/multiple rib fractures \n\n Patients with a clinically evident pelvic rim fracture \n\n Patients with signs of unstable vertebral fractures or signs of neural cord compression \n\n Patients involved in a high-energy injury mechanism \n\n Fall from height (> 3 m) \n\n As declared by prehospital emergency medical services \n\n ", - "exclusion_criteria": ": \n\n Patients suffering from a shock Class IIIB/IV \n\n Patients who need immediate neurosurgical intervention \n\n Pregnant patients \n\n Patients referred from other hospitals \n\n Patients who die at the emergency department", - "brief_summary": "The aim of this study is to establish the additional effectiveness and costs of routine thoraco-abdominal computed tomography (CT) in blunt trauma patients versus conventional radiological imaging and to determine which clinical parameters predict a high additional value of routine thoraco-abdominal CT.", - "NCTID": "NCT00228111" - }, - { - "brief_title": "Open-Label Trial of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Filgrastim in Normal Donors", - "phase": "", - "drugs": "['filgrastim']", - "drugs_list": [ - "filgrastim" - ], - "diseases": "['Normal PBPC Donors']", - "diseases_list": [ - "Normal PBPC Donors" - ], - "enrollment": "309.0", - "inclusion_criteria": "inclusion criteria: - Eligible to be PBPC donor for allogeneic transplantation as determined by local institution ", - "exclusion_criteria": ": - History of splenectomy - Previous PBPC mobilization attempts - Previous treatment with GCSF or GMCSF", - "brief_summary": "The purpose of this study is to clinically evaluate the spleen during PBPC mobilization by filgrastim in normal donors.", - "NCTID": "NCT00115128" - }, - { - "brief_title": "Screening for Asymptomatic Portal Vein Thrombosis and Portal Hypertension in Patients With Philadelphia Negative Myeloproliferative Neoplasms", - "phase": "", - "drugs": "['Upper gastrointestinal endoscopy and Doppler ultrasound']", - "drugs_list": [ - "Upper gastrointestinal endoscopy and Doppler ultrasound" - ], - "diseases": "['Myeloproliferative Neoplasms (MPN)', 'Polycythemia Vera (PV)', 'Essential Thrombocythemia (ET)', 'Myelofibrosis (MF)']", - "diseases_list": [ - "Myeloproliferative Neoplasms (MPN)", - "Polycythemia Vera (PV)", - "Essential Thrombocythemia (ET)", - "Myelofibrosis (MF)" - ], - "enrollment": "102.0", - "inclusion_criteria": "inclusion criteria: \n\n One of the three classical Philadelphia negative myeloproliferative neoplasms (polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF)) diagnosed according to WHO or International working group-Myelofibrosis research and treatment (IWG-MRT) criteria \n\n Palpable spleen length greater than 5 cm below the costal margin in MF (including primary MF or post-polycythemia vera MF (PPV-MF) post-polycythemia vera ET (PPV-ET)) or palpable spleen of any size in patients with PV or ET. \n\n Ability to understand and willing to sign a written consent form. \n\n Age 18 years or older at time of consent. \n\n ", - "exclusion_criteria": ": \n\n Known history of portal vein thrombosis \n\n Known history of Budd-chairi syndrome \n\n Known history of oesophageal varices \n\n Known history of cirrhosis from any cause \n\n Known history of active bleeding", - "brief_summary": "This study involves screening for portal vein thrombosis and portal hypertension in patients with Philadelphia negative myeloproliferative neoplasms (MPNs). These include polycythemia vera (PV), essential thrombocythemia (ET), and myelofibrosis.~Portal vein thrombosis and portal hypertension are serious complications that are often seen in myeloproliferative patients. These complications are usually diagnosed when patients become symptomatic, and are often already at an advanced stage. They can further progress to cause non-reversible damage to the liver, also called cirrhosis of the liver. As a result of this, patients often accumulate fluid in the abdomen which is ascites; and can develop swelling of veins in the lining of the esophagus known as varices. If untreated, varices have the risk of rupturing resulting in life-threatening bleeding. When diagnosed at an advanced stage, the treatment is usually supportive therapy and there are no treatments available at present which can reverse these conditions.~This study is looking at screening for these two conditions using Doppler ultrasound and upper gastrointestinal endoscopy.", - "NCTID": "NCT01816256" - }, - { - "brief_title": "A Clinical Trial of the Vessel Sealing System (LigaSure) in Azygoportal Disconnection and Splenectomy in Patients With Portal Hypertension", - "phase": "Phase 4", - "drugs": "['Vessel sealing system LigaSure']", - "drugs_list": [ - "Vessel sealing system LigaSure" - ], - "diseases": "['Liver Cirrhosis']", - "diseases_list": [ - "Liver Cirrhosis" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with liver cirrhosis accompanied by portal hypertension and secondary hypersplenism due to hepatitis, alcoholic cirrhosis or schistosomiasis, who undergoing elective azygoportal disconnection and splenectomy \n\n ", - "exclusion_criteria": ": \n\n Liver function as Child-Pugh C \n\n Hemoglobin < 9 g/dL \n\n Ascites \n\n Abnormal coagulation", - "brief_summary": "The aim of this trial was to verify the efficiency of a new surgical device (the LigaSure vessels sealing system) in esophagogastric decongestion and splenectomy in patients with portal hypertension.", - "NCTID": "NCT00965744" - }, - { - "brief_title": "Identification of Microcirculation After Surgical Treatment of Rupture of the Achilles Tendon", - "phase": "", - "drugs": "['Stitches', 'Fibrin-glue', 'Stitches and Fibrin-glue']", - "drugs_list": [ - "Stitches", - "Fibrin-glue", - "Stitches and Fibrin-glue" - ], - "diseases": "['Microcirculation', 'Achilles Tendon Rupture']", - "diseases_list": [ - "Microcirculation", - "Achilles Tendon Rupture" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Acute rupture of the achilles tendon (on one or both sides) \n\n Older than 18 year of age \n\n Firmed letter of approval \n\n Patient speaks/understands German \n\n Planed surgical treatment \n\n No more than 48h after rupture \n\n ", - "exclusion_criteria": ": \n\n No-traumatic rupture of the achilles tendon \n\n More than 48h after rupture \n\n No planed surgical treatment \n\n History of surgery on the injured leg \n\n Condition of diabetes mellitus \n\n Condition of peripheral artery occlusive disease", - "brief_summary": "This project investigates microcirculation in skin and tendon after a rupture of the Achilles tendon. Three different treatments are compared: stitches of the tendon, fibrin-glue and the combination of both.", - "NCTID": "NCT01265004" - }, - { - "brief_title": "the Role of Total Body Imaging in Asymptomatic Pediatric Trauma Patients", - "phase": "", - "drugs": "['whole body CT scan']", - "drugs_list": [ - "whole body CT scan" - ], - "diseases": "['Injuries and Wounds']", - "diseases_list": [ - "Injuries and Wounds" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n All asymptomatic trauma patients from 0 to 15 years old \n\n ", - "exclusion_criteria": ": \n\n Any pediatric trauma patients with clinical indications for CT scan", - "brief_summary": "Whole body imaging has no role in asymptomatic pediatric trauma patients", - "NCTID": "NCT00424736" - }, - { - "brief_title": "Comparing Use of a Prehospital Ultrasound System and Standard Prehospital Care in Thoracoabdominal Trauma", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Thoracoabdominal Trauma', 'Focused Assessment With Sonography for Trauma (FAST)', 'NanoMaxx Ultrasound System (SonoSite)', 'RP-Xpress (InTouch Technologies)']", - "diseases_list": [ - "Thoracoabdominal Trauma", - "Focused Assessment With Sonography for Trauma (FAST)", - "NanoMaxx Ultrasound System (SonoSite)", - "RP-Xpress (InTouch Technologies)" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria for FAST cohort: \n\n Patient is 18 years of age or older \n\n Patient presenting with blunt or penetrating trauma to the thorax or abdomen \n\n Patient transported by MD Ambulance to Royal University Hospital \n\n Patient being transported by a paramedic who has received training in the above ultrasound system and who has with them a NanoMaxx Ultrasound System (SonoSite) to be used in connection with the RP-Xpress (InTouch Technologies) \n\n Patient will take longer than 10 minutes to transport to hospital \n\n Patient's care will not be compromised in completing a FAST exam - opinion of paramedic \n\n Patient's care will not be compromised in completing a FAST exam - opinion of ER physician \n\n inclusion criteria for Controls: \n\n Patient is 18 years of age or older \n\n Patient presenting with blunt or penetrating trauma to the thorax or abdomen \n\n Patient transported by MD Ambulance to Royal University Hospital \n\n Patient will take longer than 10 minutes to transport to hospital \n\n ", - "exclusion_criteria": ": \n\n Patients under the age of 18 \n\n Patients whose care would be compromised if other procedures of higher priority (as determined by paramedics and/or remotely-present physicians) were not be able to be executed due to time involved in completing a FAST exam \n\n Patients who are not being transported to Royal University Hospital \n\n Patients whose expected transport time from scene to hospital is less than 10 minutes", - "brief_summary": "The NanoMaxx Ultrasound System (SonoSite) in connection with the RP-Xpress (InTouch Technologies) provides a means of transmitting ultrasound images, video, and audio to a remote location in real-time. It has been envisioned that this system be used to diagnose trauma patients with suspected pleural effusion, hemothorax, pneumothorax, or abdominal blockage during prehospital care; under the guidance of in-hospital physicians, paramedics would perform an Focused Assessment with Sonography for Trauma (FAST) examination while trauma patients are transported to hospital via ambulance. The investigators hypothesize that in-hospital physicians interpreting ultrasound images obtained by paramedics during trauma patients' transportation to hospital will reduce time to diagnosis; thus, preparations by emergency physicians, surgeons, and operating room teams to receive critically injured patients may begin earlier, reducing time to intervention during a critical period in patient care. Data will also be collected regarding quality of images obtained in-ambulance and the interaction between paramedics and physicians using the remote-presence system.", - "NCTID": "NCT02198885" - }, - { - "brief_title": "Thoracic Endovascular Repair Versus Open Surgery for Blunt Injury", - "phase": "", - "drugs": "['Open repair of thoracic aorta injury', 'TEVAR']", - "drugs_list": [ - "Open repair of thoracic aorta injury", - "TEVAR" - ], - "diseases": "['Blunt Injury']", - "diseases_list": [ - "Blunt Injury" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of blunt aortic injury (BAI) \n\n ", - "exclusion_criteria": ": \n\n Clinical diagnosis of penetrating aortic injury", - "brief_summary": "This study aims to increase understanding of the short-term and long-term outcome of blunt aortic injury (BAI) and to discern if there is an advantage resulting from the type of operative treatment used to manage it, either the classic open surgical repair or a newer technique known as thoracic endovascular repair (TEVAR). Specifically, this study will answer the following questions regarding patients suffering BAI:~What clinical variables affect short-term mortality and neurologic outcome?~What are the long-term treatment-associated complications of open repair and TEVAR?~In patients with a similar injury and physiologic profile, is there a survival advantage resulting from the type of operative treatment?", - "NCTID": "NCT01852773" - }, - { - "brief_title": "Tissue and Hematopoietic/Mesenchymal Stem Cell for Humanized Xenograft Studies in Melanoma and Squamous Head and Neck Cancer", - "phase": "", - "drugs": "['Filgrastim']", - "drugs_list": [ - "Filgrastim" - ], - "diseases": "['Malignant Melanoma', 'Head and Neck Cancer']", - "diseases_list": [ - "Malignant Melanoma", - "Head and Neck Cancer" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Biopsy proven incurable melanoma or incurable HNSCC amenable to have biopsy and/or surgical resection of either the primary and/or locoregional metastatic site, at the University of Colorado Hospital. \n\n Age \u2265 21 years old per NCI/NIH guidelines \n\n Eastern Cooperative Oncology Group (ECOG) performance status of 0. 1, or 2 \n\n Adequate bone marrow, hepatic and renal function: \n\n Absolute neutrophil count \u2265 1,500/\u00b5L. \n\n Platelets \u2265 100,000/\u00b5L. \n\n Hemoglobin \u2265 9.0 g/dL. \n\n Creatinine \u2264 1.5x upper limit of normal (ULN) or calculated creatinine clearance \u2265 60 mL/min. \n\n Total bilirubin \u2264 1.5x ULN. \n\n Aspartate Aminotransferase (AST)/Alanine Aminotransferase ( ALT) \u2264 2x ULN. \n\n Measurable disease according to Response Criteria in Solid Tumors (RECIST) version 1.1. \n\n O2 saturation \u2265= 93% at room air. \n\n Ability to understand and willingness to sign a written informed consent document \n\n ", - "exclusion_criteria": ": \n\n Contraindication (absolute or relative) to granulocyte colony-stimulating factor (G-CSF) filgrastim usage: \n\n known hypersensitivity to E coli-derived proteins' filgrastim, or any other component of the product. \n\n Sickle cell disorders. \n\n Clinically significant and active lung hemorrhagic or inflammatory disease, including but not limited to chronic obstructive pulmonary disease (COPD), autoimmune disease, and alveolar hemorrhage; or hypoxemia of any etiology requiring oxygen. \n\n Clinically significant splenomegaly or splenic metastases; history of splenic rupture, recent splenic trauma or other clinically significant splenic disease that increases the risk of splenic rupture. \n\n Clinically significant and active malignancy other than incurable melanoma or head and neck squamous cell cancer. \n\n Known hepatitis B or C, or HIV.", - "brief_summary": "The overall goal of this study is to develop a pre-clinical platform of melanoma and head and neck squamous cell cancer that will allow the investigators to learn more about these diseases and discover better and more individualized treatments.", - "NCTID": "NCT02331134" - }, - { - "brief_title": "FLEX-Trial: Prospective Sonographic Assessment Of Healing Process Following Suture of Profound Flexor Tendon Due to Traumatic Rupture of FDP-Tendon in Zone II.", - "phase": "", - "drugs": "['Ultrasound']", - "drugs_list": [ - "Ultrasound" - ], - "diseases": "['Tendon Injury']", - "diseases_list": [ - "Tendon Injury" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients with traumatic rupture of FDP-tendon in zone II. \n\n ", - "exclusion_criteria": ": \n\n < 18years; \n\n Fracture; \n\n crush injury; (partial) amputation; \n\n RA; \n\n CPPD; \n\n CP;", - "brief_summary": "To prospectively assess the healing process following suture of profound fexor tendon due to traumatic rupture of FDP-Tendon in Zone II by ultrasound.", - "NCTID": "NCT01013428" - }, - { - "brief_title": "Prospective Randomized Comparison of Clinical Results of Hand Assisted Laparoscopic Splenectomies and Open Splenectomies", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Postoperative Pain']", - "diseases_list": [ - "Postoperative Pain" - ], - "enrollment": "27.0", - "inclusion_criteria": "inclusion criteria: \n\n Splenomegaly 15 cm or longer spleens \n\n Patient confirmation to join the study \n\n ", - "exclusion_criteria": ": \n\n Normal sized spleens \n\n Patient denial", - "brief_summary": "ABSTRACT~Background: Although there are some comparative studies between laparoscopy and hand-assisted laparoscopic splenectomy (HALS) in splenomegaly cases, there is no study of the differences between HALS and open splenectomy (OS). Our aim was to compare the HALS and OS techniques in splenomegaly cases.~Methods: This prospective study included 27 patients undergoing splenectomy for splenic disorders at the Department of General Surgery, Istanbul Medical Faculty between February 2007 and October 2007. OS was performed on 14 patients, and HALS was performed in the other 13 patients.~Key words: HALS, open splenectomy, splenomegaly", - "NCTID": "NCT00754806" - }, - { - "brief_title": "Dose Escalation of Cisplatin Hyperthermic Intraperitoneal Chemotherapy After Surgery in Patients With Unresectable Stage IIIC Ovarian, Tube or Peritoneal Primary Adenocarcinoma", - "phase": "Phase 1", - "drugs": "['Cisplatin', 'Bevacizumab']", - "drugs_list": [ - "Cisplatin", - "Bevacizumab" - ], - "diseases": "['Ovarian Adenocarcinoma', 'Fallopian Tube Adenocarcinoma', 'Primary Peritoneal Carcinoma']", - "diseases_list": [ - "Ovarian Adenocarcinoma", - "Fallopian Tube Adenocarcinoma", - "Primary Peritoneal Carcinoma" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Stage IIIC unresectable ovarian, tubes or peritoneal primitive adenocarcinoma according to FIGO classification previously treated with 6 cycles of carboplatin-cisplatin neoadjuvant chemotherapy with a response allowing complete surgery after the 6 cycles \n\n Time frame between the sixth platin injection and the CRS + HCIP < 10 weeks \n\n No disease progression during the neoadjuvant chemotherapy \n\n 18 /= 1.5x10^9/L, platelets >/= 150x10^9/L, hemoglobin > 9 g /dl (transfusion allowed) \n\n Hepatic function : Bilirubin 60 ml/min (Cockcroft formula) and urinary strip <2 (If urinary strip >/= 2, proteinuria < 1g/24h) \n\n Plasmatic albumine > 25 g/l \n\n HIV negative status \n\n Affiliation to social security \n\n Signed informed consent \n\n ", - "exclusion_criteria": ": \n\n Incomplete cell kill surgery \n\n Non-epithelial ovarian cancer \n\n Borderline tumors \n\n Non in complete remission previous cancer for more than 5 five years before inclusion \n\n Uncontrolled high blood pressure (blood pressure > 150/100 mm Hg despite antihypertensive treatment) \n\n Previous abdominal or pelvic radiotherapy \n\n Previous pathology of the central nervous system, except for well controlled pathology like epilepsy \n\n Previous stroke, transient ischemic attacks or subarachnoid hemorrhage \n\n Previous pulmonary embolism \n\n Pregnant or breastfeeding women (Women in age must have a blood negative pregnancy test at least 15 days before going under surgery) \n\n Participation to an other clinical trial within 30 days before inclusion in the study \n\n Known hypersensitivity to platin or bevacizumab \n\n Not healed wound, ulcer or bone fracture \n\n Previous haemorrhagic or thrombotic malfunction < 6 months \n\n Significant CArdiovascular disorder including: \n\n Heart attack or unstable angina within the 6 months before inclusion \n\n Grade > 1 congestive heart failure according to the NYHA classification \n\n Uncontrolled cardiac arrhythmia despite of treatment (patients with atrial fibrillation for which the pace is under control can be include) \n\n Long term or recent (within 10 days before inclusion) medication using Aspirin at dosage > 325 mg/day \n\n Long term or recent (within 10 days before inclusion) medication using anticoagulant per os or parenteral or thrombolytic given at full dosage for therapeutic purpose. \n\n Grade > 1 previous sensory and motor neuropathies according to CTC AE V4.0 \n\n Previous abdominal fistula, GI perforation or intra-abdominal abscess within 6 months before first administration of bevacizumab \n\n Proof of any other disease, metabolic malfunction, physical or laboratory exam showing any possibility of disease or condition contraindicating administration of the drug under trial or exsposing the patient to several complications related to the treatment. \n\n Persons deprived of liberty \n\n Impossibility to comply with the medical following of the treatment for geographical, social or mental reason", - "brief_summary": "HCIP has shown efficacy in treatment of peritoneal carcinosis from colorectal background. Few studies have been published on the use of HCIP in peritoneal carcinosis from ovarian background but most of them were non-randomized phase II studies on a small population using different type of drugs and dosage. before this heterogeneity it seems necessary to standardize the utilization modalities of HCIP in peritoneal carcinosis from ovarian background", - "NCTID": "NCT02217956" - }, - { - "brief_title": "Intraperitoneal Analgesia After Laparoscopic Cholecystectomy", - "phase": "", - "drugs": "['lignocaine', 'bupevacaine']", - "drugs_list": [ - "lignocaine", - "bupevacaine" - ], - "diseases": "['Laparoscopic Cholecystectomy']", - "diseases_list": [ - "Laparoscopic Cholecystectomy" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of symptomatic gallstones requiring laparoscopic cholecystectomy \n\n Elective surgical procedure \n\n American Society of Anesthesiologists class I and II \n\n ", - "exclusion_criteria": ": \n\n Patients refusing randomization \n\n Patients already on analgesics \n\n Patients with acute cholecystitis \n\n Patients requiring preoperative cholangiogram or common bile duct exploration \n\n Patients having bile or stone spillage during procedure \n\n Patients requiring conversion to open procedure \n\n Patients requiring re-exploration for any reason \n\n Patients with history of allergy to local anesthetic agents", - "brief_summary": "Although laparoscopic cholecystectomy is associated with less pain than contemporary open procedures; it is definitely not pain free and the magnitude of postoperative shoulder and abdominal pain in the early postoperative period is still quite significant. This postoperative pain is a major concern not only for the patients, but also healthcare workers; and it often contributes to overnight hospital stay after this minimally invasive surgical procedure. Intraperitoneal instillation of local anesthetics at the time of surgery to control pain after laparoscopic cholecystectomy has been extensively studied in numerous randomized trials and found to be extremely useful. Lignocaine and Bupivacaine are two commonly used local anesthetic agents. In view of contradictory results from previous studies, it is not yet clear which of these two agents is superior to the other for pain control in this setting. To answer this question, we have designed a prospective randomized controlled trial and the specific aim of the study is to compare the analgesic efficacy of intraperitoneal lignocaine with intraperitoneal Bupivacaine in the postoperative setting after laparoscopic cholecystectomy.~If we can improve pain control after this minimally invasive procedure, it might result in decreased postoperative requirement of narcotic analgesia and its associated side-effects. It may also result in early recovery and the same day discharge of the patients with significant cost-containment for the patient and healthcare systems in future.", - "NCTID": "NCT00950625" - }, - { - "brief_title": "Trial Comparing Single Versus Double Incision to Repair Distal Bicep Tendon Ruptures", - "phase": "", - "drugs": "['Distal bicep tendon reconstruction']", - "drugs_list": [ - "Distal bicep tendon reconstruction" - ], - "diseases": "['Distal Bicep Tendon Rupture']", - "diseases_list": [ - "Distal Bicep Tendon Rupture" - ], - "enrollment": "92.0", - "inclusion_criteria": "inclusion criteria: \n\n Complete rupture of the Distal Bicep tendon \n\n Acute bicep tendon rupture (< 10 days since rupture) \n\n 18 years of age and older \n\n ", - "exclusion_criteria": ": \n\n Partial rupture of the Distal Bicep tendon \n\n Chronic bicep tendon Ruptures (>10 days since rupture) \n\n Under 18 years of age", - "brief_summary": "The purpose of this study to to determine whether a single incision technique or a double incision technique is more effective in the surgical treatment of distal bicep tendon ruptures. Patients will be randomized to one of the two techniques upon consenting to the study. Prior to surgery patients will have their elbow flexion, extension, pronation, and supination strength measured. Elbow Range of motion will also be measured in each of these four movements. A number of subjective questionnaires will also be administered to the patient prior to surgery. The identical objective tests and subjective questionnaires will be completed by the patient at intervals of three months, six months, one year, and two years following their surgery. Additional information from patients clinical visits may also be collected throughout the study.", - "NCTID": "NCT01322828" - }, - { - "brief_title": "Acute Anterior Cruciate Ligament Rupture; RecOnsTruction Or Repair?", - "phase": "", - "drugs": "['ACL Repair', 'ACL reconstruction']", - "drugs_list": [ - "ACL Repair", - "ACL reconstruction" - ], - "diseases": "['Anterior Cruciate Ligament Injury']", - "diseases_list": [ - "Anterior Cruciate Ligament Injury" - ], - "enrollment": "48.0", - "inclusion_criteria": "inclusion criteria: \n\n Sportive, active patient (Tegner score =/>5) \n\n Age above 18 untill 30 years at time of inclusion \n\n Primary rupture of the anterior cruciate ligament, evidence by history (acute trauma, clicking sensation, swelling within a few hours, instability) and physical examination (positive Lachman, anterior drawer test and/or Pivot shift) \n\n Primary rupture indicated by MRI \n\n No associated ligamentuous disorde of the knee, evidenced by history, physical examination, x-ray or MRI) \n\n Time span between anterior cruciate ligament rupture and operation no longer than 21 days \n\n Willingness to comply to advised rehabilitation protocol supervised by (NFVS registrated) sports physiotherapist \n\n ", - "exclusion_criteria": ": \n\n Infection \n\n Known hypersensitive response for materials used (Cobalt, chroom, nickel) \n\n Serieus pre-existing malaligment of leg indicated for surgery \n\n Tendency for excessive scar tisseu formation, such as arthrofibrosis \n\n History of previous surgery on leg indicated for surgery \n\n History of removal of tendon on leg indicated for surgery \n\n Muscular, neurological or vascular disorders negatively affecting healing or rehabilitation \n\n Cartilage injury requiring (some kind of) cartilage repair surgery (such as microfracture or cell therapy) \n\n Arthrosis more dan ICRS grade 2 evidenced by x-ray \n\n Long(er) term use of relevant medication, such as prednisolon or cytostatica \n\n Pregnancy \n\n Know osteoporosis", - "brief_summary": "To investigate the hypothesis that suture repair of a ruptured vkb, combined with a dynamic intraligamentary stabilization and microfracture of the femoral notch, results in at least equal effectiveness compared with an ACL reconstruction using autologous hamstring in terms of functional recovery one year postoperatively in terms of a patient self-reported outcome related to be able to conduct daily and sporting activities. Secondary, the evaluation of clinical outcomes, self-reported by the patient outcomes, osteoarthritis, rehabilitation time required for return to daily and sporting activities and levels of sporting activity which has returned in patients with status after an ACL rupture and suture repair augmented with a dynamic intraligamentary microfracture and stabilization of the femoral notch in comparison with an anterior cruciate ligament reconstruction with the ipsilateral hamstring graft.", - "NCTID": "NCT02310854" - }, - { - "brief_title": "Hyperthermic Intraperitoneal Oxaliplatin for Peritoneal Malignancies", - "phase": "Phase 1", - "drugs": "['fluorouracil', 'leucovorin calcium', 'oxaliplatin', 'cytoreductive surgery']", - "drugs_list": [ - "fluorouracil", - "leucovorin calcium", - "oxaliplatin", - "cytoreductive surgery" - ], - "diseases": "['Peritoneal Cavity Cancer']", - "diseases_list": [ - "Peritoneal Cavity Cancer" - ], - "enrollment": "17.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients must have histologic proof of peritoneal metastases (includes adenomucinosis) \n\n Complete tumor resection possible (may include liver metastasis if treatable by resection or radiofrequency ablation) \n\n Patients may have received previous chemotherapy (except peritoneal) and/or immunotherapy. If previous chemotherapy, at least 4 weeks must have passed since last dose. \n\n Patients may have received previous radiation therapy, however radiation to the large bowel, small bowel and/or stomach will make the patient ineligible for this study. \n\n Patients must have a Karnofsky performance score of \u2265 80%. \n\n Adequate hematologic, renal and hepatic function within 14 days of registration defined as: \n\n White blood count (WBC) \u2265 3,000 \n\n platelet count \u2265 70,000, \n\n serum bilirubin \u2264 2.0 mg/dL, \n\n serum creatinine \u2264 1.5 mg/dL \n\n Patients must be at least 18 years of age \n\n Patients must be able to provide informed consent \n\n ", - "exclusion_criteria": ": \n\n Metastatic disease is present outside the peritoneal cavity \n\n Diagnosis of mesothelioma \n\n Grade 2 or higher sensory neuropathy at time of study enrollment \n\n History of allergic reaction to platinum compounds \n\n Pregnant or lactating women. Pregnancy is a contraindication for receiving therapy, thus where relevant, patients will be required to use effective birth control. The agents used in this study include those which are pregnancy category D - clear evidence of risk in pregnancy. There is no information on the excretion of agents into breast milk therefore patients must refrain from breastfeeding while receiving study therapy. \n\n Previous peritoneal chemotherapy. \n\n Patients with uncontrolled concurrent medical problems (i.e. diabetes mellitus) or history of uncontrolled cardiovascular disease (no history of hospitalization for acute myocardial infarction or congestive heart failure (CHF) within 3 months prior to registration). \n\n Patients have psychiatric or addictive disorders that preclude obtaining informed consent.", - "brief_summary": "RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Peritoneal infusion of heated and nonheated chemotherapy drugs after surgery may kill more tumor cells.~PURPOSE: This phase I trial is studying the side effects and best dose of hyperthermic intraperitoneal oxaliplatin followed by intraperitoneal leucovorin and fluorouracil in treating patients with peritoneal cancer.", - "NCTID": "NCT00625092" - }, - { - "brief_title": "PATH-2: Platelet Rich Plasma in Achilles Tendon Healing", - "phase": "", - "drugs": "['PRP Injection into Achilles tendon rupture gap', 'Imitation Injection into Achilles tendon rupture gap']", - "drugs_list": [ - "PRP Injection into Achilles tendon rupture gap", - "Imitation Injection into Achilles tendon rupture gap" - ], - "diseases": "['Achilles Tendon Rupture']", - "diseases_list": [ - "Achilles Tendon Rupture" - ], - "enrollment": "230.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient is willing and able to give informed consent for participation in the study \n\n Aged 18 years or over \n\n Ambulatory prior to injury without the use of walking aids or assistance of another person \n\n Diagnosed with an acute, complete, Achilles tendon rupture \n\n Presenting within and receiving study treatment within 12 days post injury \n\n Patients in whom the decision has been made for non-operative treatment \n\n Able (in the Investigator's opinion) and willing to comply with all study requirements \n\n Able to attend a PATH-2 study hospital site for the 24-week follow-up. \n\n ", - "exclusion_criteria": ": \n\n The patient may not enter the study if any of the following apply: \n\n Achilles tendon injuries at the insertion to the calcaneum or at the musculotendinous junction \n\n Previous major tendon or ankle injury or deformity to either lower leg \n\n History of diabetes mellitus \n\n Known platelet abnormality or haematological disorder \n\n Current use of systemic cortisone or a treatment dose of an anticoagulant (i.e. a prophylactic dose for preventing thrombosis would not be an exclusion) \n\n Evidence of lower limb gangrene/ulcers or peripheral vascular disease \n\n History of hepatic or renal impairment or dialysis \n\n Female patients who are pregnant or breast feeding \n\n Is currently receiving or has received radiation or chemotherapy within the last 3 months \n\n Has inadequate venous access for drawing blood \n\n Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the patient's ability to participate in the study.", - "brief_summary": "Platelet Rich Plasma in Achilles Tendon Healing~Does using a Platelet Rich Plasma (PRP) injection immediately before standard casting benefit patients aged 18 or over who are suitable for nonsurgical treatment of the Achilles tendon rupture (ATR)? This is a multicentre, blinded, randomised, placebo controlled trial with two sub studies: (1) blood sample analysis and (2) needle biopsy in 16 participants.~ATR is the most common tendon injury and leads to months of incapacity. With an average work absence of 63108 days there are significant societal and National Health Service (NHS) costs. PRP potential benefit is to improve recovery and return to normal activities earlier, and reduce the NHS and societal impact. The investigators will investigate the efficacy of PRP using disease specific and patient important outcomes to improve the evidence for this treatment of ATR.~A minimum of 15 United Kingdom (UK) NHS hospitals will be included to recruit 214 participants. Patients will be identified in the orthopaedic outpatient clinic, usually following an emergency hospital attendance for ATR. After checking eligibility and the informed consent process, baseline data is collected and participants randomised to either 'PRP injection' or 'Imitation (placebo) injection'. A participant's own blood sample is taken and prepared according to allocation. The injection is delivered by a trained surgeon in clinic who will be aware of allocation while the participant remains blind.~Participants complete a pain diary and have four study assessments at 4,7,13 and 24 weeks, carried out by a member of the research team blind to allocation. Assessments take place over the telephone or during a hospital outpatient visit. The 24 week hospital visit includes an exercise test of ankle function. All assessments include collection of patient reported responses to pre-set questions.~The results may be applicable to the many other tendon and ligament injuries. The National Institute for Health Research (NIHR)/Medical Research Council (MRC) Efficacy and Mechanism Evaluation Programme provides funding and University of Oxford is Sponsor.", - "NCTID": "NCT02302664" - }, - { - "brief_title": "Plain Magnetic Resonance (MR) in the Assessment of Patients With Acute Abdomen", - "phase": "", - "drugs": "['MR scan']", - "drugs_list": [ - "MR scan" - ], - "diseases": "['Acute Abdomen']", - "diseases_list": [ - "Acute Abdomen" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Signed informed consent form \n\n Age > 18 years old \n\n Nontraumatic acute abdomen \n\n Weight < 120kg \n\n Can keep apnoea for 15s \n\n Surgeon in charge considers patient fit for participation in study \n\n ", - "exclusion_criteria": ": \n\n Contraindications of MRI \n\n Suspicion of acute vascular disease \n\n Severe cardial or pulmonal insufficiency \n\n Pregnancy \n\n Untreated psychiatric illness", - "brief_summary": "At present, CT is the gold standard in the assessment of patients with acute abdomen. Yet, one CT of the abdomen exposes patients to a radiation dose equivalent to several years of background radiation. MR can be expected to yield the same information without ionizing radiation, but tends to be more time consuming. In this study, patients with nontraumatic acute abdominal pain referred to CT of the abdomen by the department of surgery will also have performed an additional MR scan covering the entire abdomen with few fast imaging sequences in approximately 15min. CT is the diagnostic test. The MR scan is only used for scientific purposes. It will be evaluated by a radiologist blinded for the results of the CT scan. Fourteen days after admission, a final diagnosis is established based on clinical, peroperative, pathological and lab. findings. The performance of CT and MR will then be compared. The investigators hypothesize that MR can provide a diagnostic accuracy comparable to CT.", - "NCTID": "NCT01044173" - }, - { - "brief_title": "Tenecteplase Pulmonary Embolism Italian Study", - "phase": "Phase 2", - "drugs": "['tenecteplase']", - "drugs_list": [ - "tenecteplase" - ], - "diseases": "['Pulmonary Embolism']", - "diseases_list": [ - "Pulmonary Embolism" - ], - "enrollment": "180.0", - "inclusion_criteria": "inclusion criteria: \n\n age between 18 and 85; \n\n symptomatic PE confirmed by: high probability lung scan, or intermediate probability lung scan and objectively confirmed deep vein thrombosis, or spiral CT-scan or pulmonary angiography or TE echocardiography; \n\n normal blood pressure (SBP >100mmHg); \n\n RVD at echocardiography (see criteria); \n\n written informed consent. \n\n ", - "exclusion_criteria": ": \n\n absence of RVD at echocardiography; \n\n shock or hypotension (SBP < 100 mmHg); \n\n therapeutic heparin (UFH or LMWH) treatment for more than 48 hours prior to randomization; \n\n administration of thrombolytic agents within the previous 4 days; \n\n vena cava filter insertion or pulmonary thrombectomy within the previous 4 days \n\n chronic pulmonary hypertension or severe COPD; \n\n hypertension defined as blood pressure >180/110 mm Hg (systolic BP >180 mm Hg and/or diastolic BP >110 mm Hg) on a single, reliable measurement during current admission at enrolling site prior to randomisation; \n\n use of GP IIb/IIIa antagonists within the preceding 7 days; \n\n significant bleeding disorders either at present or within the past 6 months; \n\n active peptic ulceration; \n\n known diabetic haemorrhagic retinopathy or other haemorrhagic ophthalmic conditions; \n\n known haemorrhagic diathesis; \n\n known arterial aneurysm and known arterial/venous malformation; \n\n known neoplasm with increased bleeding risk; \n\n prolonged cardiopulmonary resuscitation (>10 minutes) in the previous two weeks; \n\n current oral anticoagulation; \n\n major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months; \n\n any known history of stroke or transient ischaemic attack (TIA) or dementia; \n\n any recent head trauma and any other trauma occurring after onset of the current pulmonary embolism; \n\n any known history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery); \n\n known subacute bacterial endocarditis; \n\n known acute pancreatitis; \n\n known severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension \n\n (oesophageal varices) and active hepatitis; \n\n pregnancy or lactation or parturition within the previous 30 days; \n\n women of childbearing potential must have a negative pregnancy test, or use a medically accepted method of birth control; \n\n treatment with an investigational drug under another study protocol in the past 7 days; \n\n previous enrolment in this study; \n\n known hypersensitivity to Tenecteplase, Alteplase, unfractionated heparin, or to any of the excipients; \n\n anticipated or obvious problem with vascular access; \n\n any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated; \n\n inability to follow protocol requirements", - "brief_summary": "To assess the efficacy and safety of Tenecteplase versus Placebo in normotensive patients with sub-massive Pulmonary Embolism and Right Ventricular Dysfunction (RVD) all receiving unfractionated heparin (UFH)", - "NCTID": "NCT00222651" - }, - { - "brief_title": "Handlebar Grip Related Injury Prevention (GRIP) Study: Are Exposed Metal Handlebar Ends a Risk Factor for Injury?", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Injuries', 'Trauma', 'Wounds and Injuries', 'Children', 'Child']", - "diseases_list": [ - "Injuries", - "Trauma", - "Wounds and Injuries", - "Children", - "Child" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Children 0-15 years inclusive \n\n Presenting to either of the study hospitals for assessment or treatment \n\n Sustained an injury or suspected to have sustained an injury (i.e. AIS >=0) \n\n Due to an incident involving any non-motorized bicycle, tricycle or kick scooter \n\n ", - "exclusion_criteria": ": \n\n Incidents where the injured child was involved in a motor vehicle collision \n\n Incidents where the injured child was injured by another rider (e.g. injured child run over by a cyclist) \n\n Incidents involving a bicycle fitted with 'bull bars' \n\n Patients for whom neither parent / guardian is fluent in English (if the history is clear from a parent, the patient will be eligible for inclusion) \n\n If an eligible patient is dead on arrival the family will not be invited to participate, and they will not subsequently be contacted \n\n If an eligible patient dies during their admission, they will be withdrawn from further involvement in the study and the family will not be contacted", - "brief_summary": "Cycling injuries are the 3rd most common mechanism of injury in 7-13 year olds[1]. Bicycle injuries have remained one of the commonest causes of paediatric abdominal trauma for over 60 years[2,3]. 15% of child cyclist injuries involve impact with a handlebar; two-thirds of those are abdominal injuries[4]. Handlebar impact is now the commonest mechanism of major paediatric abdominal injury[3]. Serious handlebar injuries often occur after apparently minor falls; they are not unique to riders performing stunts[5].~One small study found that the metal handlebar ends were often exposed on bikes of children sustaining severe abdominal injuries[6]. Most European safety standards do not test grip durability[7-10]. Day-to-day use can damage rubber grips, exposing the underlying metal handlebar tube.~This feasibility study aims to test the research methods that will be used in a subsequent nationwide multicentre study. The main study will investigate the association between injuries and handlebar grip condition.~Children attending study hospitals with any bicycle or kick scooter injury will be invited to participate. Parents of injured children will be invited to complete questionnaires regarding circumstances surrounding the injury and condition of the handlebar ends on the bike or scooter involved. Clinical information regarding the injury will also be collected. The handlebar end condition will be compared between children sustaining a handlebar end injury [Cases] and riders whose injury did not involve the handlebar [Controls].~If exposed handlebar ends are more prevalent amongst riders with handlebar end injuries, injury prevention strategies can focus on methods to prevent damage occurring to grips through day-to-day use. If no such association is found, prevention strategies can be focused elsewhere, such as on design of effective protective clothing.~Data collection for this feasibility study will occur between March 2015 and September 2015.~The Chief Investigator, Mr. Andrew Neilson, funds the feasibility study.", - "NCTID": "NCT02378311" - }, - { - "brief_title": "Rituximab as Second Line Treatment for ITP", - "phase": "Phase 3", - "drugs": "['Rituximab (Mabthera)']", - "drugs_list": [ - "Rituximab (Mabthera)" - ], - "diseases": "['Immune Thrombocytopenia (ITP)']", - "diseases_list": [ - "Immune Thrombocytopenia (ITP)" - ], - "enrollment": "112.0", - "inclusion_criteria": "inclusion criteria: \n\n ITP with platelet count <30 x 109 /l after 2 weeks of treatment with prednisolon or during prednisolon tapering period i.e. from week three of prednisolon initiation. Patients with platelet count between 30 -50 are eligible if a higher platelet count is considered necessary, because of : concomitant medical illness predisposing to bleeding (hypertension, GI bleeding, bleeding diathesis, previous history of bleeding) concomitant medical condition requiring platelet blocking agents/ anticoagulation, persistent bleeding despite platelets > 30 x 109 /l, prior to surgery, or because of other patient related factors necessitating higher platelet count as occupation, hobby, psychological intolerability. \n\n Subject is >18 years \n\n Subject has signed and dated written informed consent. \n\n Subject is able to understand and comply with protocol requirements and instructions, and intends to complete the study as planned. \n\n Females in fertile age should express willingness for use of contraceptive means for 6 months following the administration of the study drugs. \n\n ", - "exclusion_criteria": ": \n\n Previous splenectomy, chemotherapy, treatment with anti-D Ig, rituximab, or immune-suppressive treatments other than corticosteroids, Dapsone or Danazol \n\n Underlying malignancy or previous history of malignancy in the past 5 years (except skin carcinoma) \n\n Pregnancy and lactation \n\n Not willing to participate in the study \n\n Expected survival of < 2 years \n\n Known intolerance to murine antibodies \n\n Females in child-bearing age not willing to use contraception for 6 months \n\n HIV-positive/AIDS-, Hepatitis -B virus positive- or Hepatitis -C virus positive \n\n Patients with a definite Systemic Lupus Erythematosus (SLE) (> 4 of the American College of Rheumatology Criteria) \n\n Patients currently involved in another clinical trial with evaluation of drug treatment \n\n Bacterial infections, viral infections, fungal infections, myco-bacterial infections (excluding fungal infections) or other evolutive infections or any other infections episode requiring hospitalisation or treatment with an antibiotics 4 weeks before selection for IV route or within 2 weeks before selection for oral route \n\n History of soft tissue, bone or joint infections (fascitis, abscess, osteomyelitis, septic arthritis) during the last year prior to inclusion in the study \n\n Medical history of relapsing or chronic severe infectious diseases or any other underlying pathology predisposing to serious infections \n\n Known Primary or secondary immune deficiency syndromes \n\n Administration of a living vaccine within 4 weeks preceding the inclusion in the study -16- Previous treatment with any lymphocytes depleting medication (e.g.: MabCampath\u00ae) \n\n 17- Previous treatment with inhibitors of leucocytes transmigration (e.g.: Tysabri\u00ae) 18- Known intolerance to human monoclonal antibodies 19- Known severe chronic pulmonary obstructive Disease (FEV < 50% or functional dyspnoea grade 3) 20- Known congestive heart failure NYHA (New York Heart Association classification of heart failure) class III and IV 21- Recent episode (<6 months) of acute coronary syndrome.", - "brief_summary": "Immune thrombocytopenic purpura (ITP) is an autoimmune disorder characterized thrombocytopenia.~Splenectomy is the standard treatment for patients who fails the first-line treatment: corticosteroid. Rituximab, has recently emerged as a promising treatment for ITP. The aim of the study is to determine whether early treatment with Rituximab can result in durable remissions, and consequently, lead to the avoidance of splenectomy in a significant number of patients.", - "NCTID": "NCT00344149" - }, - { - "brief_title": "Early Functional Return to Work Following Distal Biceps Repair", - "phase": "", - "drugs": "['No splint', 'Splint']", - "drugs_list": [ - "No splint", - "Splint" - ], - "diseases": "['Biceps Tendon Rupture']", - "diseases_list": [ - "Biceps Tendon Rupture" - ], - "enrollment": "104.0", - "inclusion_criteria": "inclusion criteria: \n\n male subjects between 18 and 65 years of age \n\n patient has had a DBTR amenable to surgical repair \n\n surgeon must be able to obtain a tension-free repair using an endobutton. \n\n participants must have been working prior to the injury \n\n patient must be expected to return to work post-injury \n\n ", - "exclusion_criteria": ": \n\n females \n\n outside of the specified age range \n\n patient with an identified congenital abnormality at the insertion of the distal biceps tendon \n\n those who have previously ruptured the tendon or those with tendon ruptures resulting from a multi-trauma \n\n patients with psychiatric illness, cognitive impairment, or health conditions that preclude informed consent \n\n patients with life expectancy of less than 2 years \n\n patients who do not speak/read/understand English \n\n patients with no fixed address or contact information \n\n patients who are unwilling to complete follow-ups", - "brief_summary": "Distal biceps ruptures occur most commonly among young males in their third and fourth decade of life. These injuries are becoming more common, however, as the aging population is remaining active through sport or labour demands. Distal biceps tears or ruptures follow a heavy eccentric load being placed on a shortened or flexed muscle, and often require surgical repair. Functionally, distal biceps injuries cause impairment as this portion of the muscle is largely responsible for supination and flexion at the elbow. Currently there is no consensus regarding post-operative immobilization protocols, and little evidence is available regarding timeframe for early return to functional activities. Existing evidence on functional outcomes post distal biceps tendon repair (DBTR) is of low quality with small sample sizes, and no known RCTs exist comparing early mobilization to immobilization on functional return. Reported timeframes for immobilization range from early controlled motion on day 1 post-operatively to complete immobilization for 6 weeks.~The primary study goal is to determine the effect of immobilization compared to unrestricted mobility post DBTR on early functional return to activities. It has been previously reported that those with DBTR related to a workers compensation injury returned to full duties in 3.95 months, while those with a non-workers compensation related injury returned to full work duties in 1.35 months. In Alberta, near 100 WCB claims were made for DBTR in both 2013 and 2014. Early mobilization of these repairs may allow an earlier return to modified and full work duties, thereby improving the functional quality of life of the individual as well as reducing the overall cost of disability payments.~This study will assess the 1) time to return to pre-injury work level and 2) time to return to modified duties among those who have no movement restriction post-repair and those who are splinted for 6 weeks. Re-rupture rates between groups will also be assessed as will strength, range of motion (ROM) and quality of life. These findings will assist in developing a standardized protocol for immobilization to optimize functional and clinical outcomes while expediting return to work.", - "NCTID": "NCT02505347" - }, - { - "brief_title": "Pancreas Resection With and Without Drains", - "phase": "", - "drugs": "['No Drains', 'Drains']", - "drugs_list": [ - "No Drains", - "Drains" - ], - "diseases": "['Pancreas Tumor', 'Pancreatitis']", - "diseases_list": [ - "Pancreas Tumor", - "Pancreatitis" - ], - "enrollment": "399.0", - "inclusion_criteria": "inclusion criteria: \n\n The subject has a surgical indication for distal pancreatectomy. \n\n In the opinion of the surgeon, the subject has no medical contraindications to pancreatectomy. \n\n At least 18 years of age. \n\n The subject is willing to consent to randomization to the intraperitoneal drain vs. no drain group. \n\n The subject is willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol. \n\n ", - "exclusion_criteria": ": \n\n The subject does not have a surgical indication for distal pancreatectomy. \n\n In the opinion of the surgeon, the subject has medical contraindications to pancreatectomy. \n\n Less than 18 years of age. \n\n The subject is not willing to consent to randomization to the intraperitoneal drain vs. no drain group. \n\n The subject is not willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol.", - "brief_summary": "This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery.", - "NCTID": "NCT01441492" - }, - { - "brief_title": "Keller Prehospital Ultrasound Study", - "phase": "", - "drugs": "['EFAST exam', 'Pelvic Ultrasound', 'Ultrasound Guided Vascular Access', 'Focused Ultrasound Scan', 'Cardiac Ultrasound']", - "drugs_list": [ - "EFAST exam", - "Pelvic Ultrasound", - "Ultrasound Guided Vascular Access", - "Focused Ultrasound Scan", - "Cardiac Ultrasound" - ], - "diseases": "['Ultrasonography', 'Multiple Trauma', 'Kidney Calculi', 'Aortic Aneurysm, Abdominal', 'Pregnancy', 'Catheterization, Venous']", - "diseases_list": [ - "Ultrasonography", - "Multiple Trauma", - "Kidney Calculi", - "Aortic Aneurysm", - "Abdominal", - "Pregnancy", - "Catheterization", - "Venous" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Activation of the Keller Fire Rescue Emergency Medical Service \n\n Meets disease process criteria described earlier \n\n ", - "exclusion_criteria": ": \n\n Does not meet the disease process criteria", - "brief_summary": "The study is based on the premise that ultrasound is not commonly used in an ambulance. There are some departments that do deploy it into the field, but of those departments there is almost no data collected about its use. Currently Paramedics are not recognized by insurance companies as health care providers capable of performing ultrasound. If there were more data on the subject that may eventually change. We are hoping to prove that not only is ultrasound useful in an ambulance, but that paramedics are good at interpreting the results. We will save images, the paramedic's diagnosis and some basic information about the call. We will not save any protected health information (PHI) or any information linking the subject to the study. The data collected will be sent to a non-biased ultrasound reviewer to grade the images for the accuracy of diagnosis and the quality of the view obtained. This data will be used to formulate a report and statistics on paramedic's ability to perform ultrasound in the field.", - "NCTID": "NCT01074112" - }, - { - "brief_title": "Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair", - "phase": "", - "drugs": "['Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.', 'Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.', 'Ventralight ST implant', 'ETHICON PHYSIOMESH\u00ae']", - "drugs_list": [ - "Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.", - "Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.", - "Ventralight ST implant", - "ETHICON PHYSIOMESH\u00ae" - ], - "diseases": "['Hernia, Abdominal', 'Hernia,Ventral']", - "diseases_list": [ - "Hernia", - "Abdominal", - "Hernia,Ventral" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Informed Consent Form (ICF) signed by the patient or his/her legal representative \n\n primary or secondary ventral hernia less than 20 cm in length and less than 11 cm in width requiring elective surgical repair \n\n recurrence after former abdominal hernia repair WITH MESH \n\n recurrence after suture abdominal hernia repair CAN be included \n\n ", - "exclusion_criteria": ": \n\n no written informed consent \n\n patient under 18 years old \n\n emergency surgery (incarcerated hernia) \n\n patients with expected life time shorter than one year for example due to generalised malignancy \n\n BMI exceeding 40.0kg/m\u00b2 \n\n contaminated surgical fields \n\n patients on immunosuppression, steroid therapy, constant pain therapy", - "brief_summary": "This is a monocenter randomized controlled trial comparing two systems of mesh and fixation device for the laparoscopic ventral and incisional hernia repair with respect to pain. It has been designed as a superiority study to proof the concept of previously published mathematical model of front abdominal wall.", - "NCTID": "NCT02233569" - }, - { - "brief_title": "Sharp Versus Blunt Fascial Incision at Caesarean Section", - "phase": "", - "drugs": "['Blunt right, sharp left', 'Blunt left, sharp right']", - "drugs_list": [ - "Blunt right", - "sharp left", - "Blunt left", - "sharp right" - ], - "diseases": "['Cesarean Section']", - "diseases_list": [ - "Cesarean Section" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Woman having caesarean section for the first time \n\n Woman, who have had no previous lower abdominal surgery \n\n Woman who speak and understand Danish \n\n Woman who can give informed consent \n\n ", - "exclusion_criteria": ": \n\n Diabetes Mellitus (This does not include gestational diabetes) \n\n Infection \n\n Regular treatment with immunosuppressives \n\n Alcohol or drug abuse \n\n Age under 18 years old \n\n Chronic pain disease eg. fibromyalgia, rheumatoid arthritis \n\n BMI over 35", - "brief_summary": "The purpose of this study is to compare sharp and blunt fascial entry during caesarean section on the same patient. The study is performed on woman having cesarean section for the first time and who have not previously had lower abdominal surgery done. The following parameters are registered:~The preferred side evaluated by the patient 3 months postoperatively.~The patient evaluated difference in pain on the right vs. left side 1, 3 and 7 days and 1 and 3 months postoperatively.~The rate and side of infection.", - "NCTID": "NCT01297725" - }, - { - "brief_title": "Single-photon Emission Computed Tomography (SPECT) to Predict Peritoneal Chemotherapy", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Peritoneal Carcinomatosis']", - "diseases_list": [ - "Peritoneal Carcinomatosis" - ], - "enrollment": "51.0", - "inclusion_criteria": "inclusion criteria: \n\n Cytoreductive surgery and intraperitoneal chemotherapy \n\n Single-Photon Emission Computed Tomography (SPECT) before the second course of treatment", - "exclusion_criteria": "", - "brief_summary": "SPECT was performed in 51 patients after cytoreductive surgery in combination with intraperitoneal chemotherapy. The detected volume was compared to the number of subsequent sequential postoperative intraperitoneal chemotherapy courses that could be performed without further surgical intervention. SPECT data was found to predict feasibility of sequential postoperative intraperitoneal chemotherapy.", - "NCTID": "NCT00997633" - }, - { - "brief_title": "Impacts of Intraperitoneal Pressure and CO2 Gas on Surgical Peritoneal Environment", - "phase": "", - "drugs": "['Fisher and Paykel Humidifier (MR860AEU)']", - "drugs_list": [ - "Fisher and Paykel Humidifier (MR860AEU)" - ], - "diseases": "['Laparoscopic Hysteretctomy With Promontofixation']", - "diseases_list": [ - "Laparoscopic Hysteretctomy With Promontofixation" - ], - "enrollment": "82.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 45-75 years old \n\n Petients undergoing laparoscopic hysterectomy with promontofixation for uterine prolapse \n\n Menopaused \n\n ASA class I or II \n\n ", - "exclusion_criteria": ": \n\n Absolute contraindications to laparoscopy \n\n Previous history of pelvic surgery, endometriosis and/or infection \n\n Pathological peritoneal tissue \n\n BMI more than 30 \n\n Height less than 150cm", - "brief_summary": "Use lay language.~The primary purpose is to compare the impacts of intraperitoneal pressure (8mmHg versus 12 mmHg) and CO2 gas (cool, dry CO2 gas versus warmed, humidified CO2 gas) on gene expression in peritoneal tissues during laparoscopic surgery. We hypothesize that combined use of a low Intraperitoneal pressure (8mmHg) and warmed, humidified CO2 gas during CO2 pneumoperitoneum may be better in minimizing adverse effects on surgical peritoneal environment and improving clinical outcomes compared to the standard intraperitoneal pressure (12mmHg) and standard cool, dry CO2 gas.", - "NCTID": "NCT01887028" - }, - { - "brief_title": "Neurological Outcome in Patients of Traumatic Subarachnoid Haemorrhage", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Traumatic Subarachnoid Haemorrhage']", - "diseases_list": [ - "Traumatic Subarachnoid Haemorrhage" - ], - "enrollment": "117.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients of traumatic subarachnoid haemorrhage \n\n ", - "exclusion_criteria": ": \n\n Metabolic disorder \n\n Altered coagulation profile \n\n Cardiac disease \n\n Co- morbid illness", - "brief_summary": "Traumatic brain injury is common cause of morbidity and mortality worldwide. Incidence and pattern of traumatic brain injury varies in developed and developing countries. Subarachnoid haemorrhage refers to blood in subarachnoid space that lies between arachnoid and piameninges, covering brain. It is often associated with concurrent intracranial injury component. Individuals at higher risk for tSAH are those who are at higher risk for blunt head trauma. This includes adolescents, low-income individuals, men, and individuals with a history of substance abuse. The investigators present study aims to investigate prognostic factors associated with the neurological outcome among patients of post traumatic SAH.", - "NCTID": "NCT02073890" - }, - { - "brief_title": "Role of Serum Total Antioxidant Level in Preterm Labor", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Preterm Labor']", - "diseases_list": [ - "Preterm Labor" - ], - "enrollment": "70.0", - "inclusion_criteria": "inclusion criteria: \n\n Preterm labor(pregnant between 28th and 37th week). \n\n Singleton pregnancy. \n\n Amnion membranes were intact \n\n ", - "exclusion_criteria": ": \n\n Past history of preterm labor or premature delivery. \n\n Urinary tract infections and any other infections. \n\n Poly- or oligohydramnios. \n\n Fetal distress, fetal or uterine anomaly. \n\n Membranes rupture and placenta pathology. \n\n Preeclampsia or intrauterine growth retardation", - "brief_summary": "The aim of this study is to detect the association between maternal serum antioxidant level and preterm labor.", - "NCTID": "NCT01518816" - }, - { - "brief_title": "Continuous Topical Instillation for Open Abdomen in the Septic Patients With Complicated Intra-abdominal Infections", - "phase": "", - "drugs": "['Continuous topical triple-tube irrigation and suction', 'SOC']", - "drugs_list": [ - "Continuous topical triple-tube irrigation and suction", - "SOC" - ], - "diseases": "['Wound Infection']", - "diseases_list": [ - "Wound Infection" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n age \u2265 18 years patients with complicated intra-abdominal infections who needed open abdomen (OA) and vacuum-assisted wound closure and mesh-mediated fascial traction (VAWCM) \n\n Eligible patients were properly consented before enrollment. If the patient was incapable, the patient's legal representative was asked to provide consent on the patient's behalf. \n\n Patients with grade 1b (contaminated OA without adherence between bowel and abdominal wall), 2b (contaminated OA developing adherence) open abdomen, as classified by Bjorck. \n\n ", - "exclusion_criteria": ": \n\n < 18 years, \n\n pre-existing large ventral hernia \n\n Frozen OA with adherent bowel (OA of grade 4), \n\n Clean wound (OA of grade 1a or 2a) \n\n chronic wound infection \n\n critical wound ischemia \n\n severe systemic infection \n\n end-stage renal disease \n\n severe liver disease \n\n uncontrolled diabetes mellitus \n\n any issue with an obviously high risk of delayed wound healing", - "brief_summary": "The closed systems, such as conventional negative pressure wound therapy (NPWT), were usually avoided in infected or critical colonized wounds. To our observation, the additional continuous irrigation tube attached beside the suction tube in the NPWT system could provide the effective drainage by reducing the occlusion of suction tube, enable effective debridement by diluting infected/necrotized tissues and decrease the incidence of fistula by providing relatively moist ambient. At our institutions, the modified system combined with a triple-tube device to allow a continuous instillation became more active and efficient. The study is to investigate if a continuous triple-tube instillation and suction could improve the outcomes of acute severely infected open abdomen.", - "NCTID": "NCT02029339" - }, - { - "brief_title": "Study of Tomography of Nephrolithiasis Evaluation", - "phase": "Phase 4", - "drugs": "['Point-of-care Ultrasound', 'Radiology Ultrasound', 'Radiology CT']", - "drugs_list": [ - "Point-of-care Ultrasound", - "Radiology Ultrasound", - "Radiology CT" - ], - "diseases": "['Urolithiasis']", - "diseases_list": [ - "Urolithiasis" - ], - "enrollment": "2776.0", - "inclusion_criteria": "inclusion criteria: \n\n men or women = or >18 but <76 years of age presenting with acute renal colic \n\n Emergency department physician highly suspects a primary diagnosis of kidney stones (renal colic) or the patient requires imaging to rule out kidney stones. \n\n ", - "exclusion_criteria": ": \n\n children < 18 years old \n\n elderly patients > or = 76 years old \n\n pregnancy or planning pregnancy \n\n Morbid obesity (>285 pounds in men, >250 pounds in women) \n\n patients with an acute abdomen, signs of sepsis, signs of alternate diagnosis (ie appendicitis, abdominal aortic aneurysm, pyelonephritis, kidney stones not suspected). \n\n history of kidney problems (hemodialysis, kidney transplant, presence of only one kidney)", - "brief_summary": "This is a multi-center, randomized controlled trial of ultrasonography (ultrasound) compared to computed tomography (CT) for the initial emergency room evaluation of patients with suspected renal colic. The investigators will compare several measures of effectiveness including morbidity related to the patient's underlying disease, or complications related to delayed diagnosis, patient status regarding pain/missed days of work, and utilization of health care resources based on one of three study arms: ultrasound in the Emergency Department, ultrasound in Radiology or CT.", - "NCTID": "NCT01451931" - }, - { - "brief_title": "Comparison Study of Standard Care Against Combination of Growth Factors Agents for Low-risk Myelodysplastic Syndromes", - "phase": "Phase 3", - "drugs": "['Darbepoetin alpha', 'Filgrastim', 'Blood Red Cell Transfusion']", - "drugs_list": [ - "Darbepoetin alpha", - "Filgrastim", - "Blood Red Cell Transfusion" - ], - "diseases": "['Myelodysplastic Syndrome']", - "diseases_list": [ - "Myelodysplastic Syndrome" - ], - "enrollment": "360.0", - "inclusion_criteria": "inclusion criteria: \n\n Males and females aged over 18 years, (no upper age limit) \n\n ECOG performance status 0-2 \n\n Life expectancy more than 6 months \n\n A confirmed diagnosis of MDS - WHO type: \n\n refractory anaemia (RA) \n\n hypoplastic RA ineligible for/or failed immunosuppressive therapy (ALG, cyclosporine) \n\n refractory anaemia with ring sideroblasts (RARS) \n\n refractory cytopenia with multilineage dysplasia \n\n myelodysplastic syndrome unclassifiable \n\n IPSS low or Int-1, but with BM blasts less than 5% \n\n A haemoglobin concentration of less than 10g/dl and/or red cell transfusion dependence \n\n Able to understand the implications of participation in the Trial and give written informed consent. \n\n ", - "exclusion_criteria": ": \n\n MDS with bone marrow blasts greater or equal than 5% \n\n Myelodysplastic syndrome associated with del(5q)(q31-33) syndrome \n\n Chronic myelomonocytic leukaemia (monocytes greater than1.0x109/l) \n\n Therapy-related MDS \n\n Splenomegaly, with spleen greater or equal than 5 cm from left costal margin \n\n Platelets less than 30x109/l \n\n Uncorrected haematinic deficiency. Patient deplete to iron, B12 and folate according to local lab ranges \n\n Women who are pregnant or lactating. \n\n Females of childbearing potential and all males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) for the duration of the study and for up to 3 months after the last dose of study medication. Note: Subjects are not considered of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal \n\n Females of childbearing potential must have a negative pregnancy test prior to starting the study. \n\n Uncontrolled hypertension, previous venous thromboembolism, or uncontrolled cardiac or pulmonary disease \n\n Previous serious adverse events to the study medications or its components \n\n Patients who have had previous therapy with ESAs \u00b1 G-CSF within 4 weeks of study entry \n\n Patients currently receiving experimental therapy, e.g. with thalidomide, or who are participating in another CTIMP. \n\n Medical or psychiatric illness, which makes the patient unsuitable or unable to give informed consent. \n\n Patients with malignancy requiring active treatment (except hormonal therapy). \n\n Patients with a history of seizures", - "brief_summary": "REGIME is comparing two treatments, with Darbepoetin Alpha (DA) and Filgrastim (Granulocyte Colony Stimulating Factor, G-CSF), to the standard treatment for Myelodysplastic Syndrome (MDS).~After giving Informed Consent patients will undergo a number of tests to confirm eligibility. Once eligibility is confirmed patients will be randomly assigned to one of the three treatments group: A: Darbepoetin Alpha (DA), B: Darbepoetin Alpha and Filgrastim (DA+G-CSF), C: Blood transfusion only. Patients will be required to attend the clinic once a month for 24 weeks. After 24 weeks if a patient has reacted favorably to the treatment they may continue on the treatment regime up to 52 weeks. After week 24 all patients will be required to attend the clinic twice more, at week 36 and 52.~Patients will be followed for a further 5 years to record loss of response, transformation to Acute Myeloid Leukaemia and/or Refractory Anemia with Excess Blasts and death.", - "NCTID": "NCT01196715" - }, - { - "brief_title": "Clinical Outcome Study of ARC1779 Injection in Patients With Thrombotic Microangiopathy", - "phase": "Phase 2", - "drugs": "['ARC 1779 Placebo', 'ARC1779 Injection', 'ARC1779 Injection', 'ARC1779 Injection']", - "drugs_list": [ - "ARC 1779 Placebo", - "ARC1779 Injection", - "ARC1779 Injection", - "ARC1779 Injection" - ], - "diseases": "['Thrombotic Microangiopathy', 'Thrombotic Thrombocytopenic Purpura']", - "diseases_list": [ - "Thrombotic Microangiopathy", - "Thrombotic Thrombocytopenic Purpura" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female; \n\n \u226518 to \u226475 years of age; \n\n Diagnosis of TMA based on presence of: \n\n Thrombocytopenia, defined as a platelet count <100 x 109 per liter; \n\n Microangiopathic hemolytic anemia, defined by negative findings on direct antiglobulin test, and evidence of accelerated red blood cell (RBC) production and destruction); AND \n\n Absence of a clinically apparent alternative explanation for thrombocytopenia and anemia, e.g., disseminated intravascular coagulation (DIC), eclampsia, HELLP syndrome, Evans syndrome; \n\n Females: non-pregnant and commit to use of effective, redundant methods of contraception (i.e., for both self and male partner) throughout the study and for at least 30 days after discontinuation of study drug treatment; \n\n Males: commit to use of a medically acceptable contraceptive (abstinence or use of a condom with spermicide) throughout the study and for at least 30 days after discontinuation of study drug treatment; \n\n Not received an unlicensed investigational agent (drug, device, or blood-derived product) within 30 days prior to randomization, and may not receive such an investigational agent in the 30 days post-randomization (note: investigational use for treatment of TMA of a licensed immunomodulator, e.g., rituximab, is permitted at any time relative to randomization); \n\n Capable of understanding and complying with the protocol, and he/she (or a legal representative) must have signed the informed consent document prior to performance of any study-related procedures. \n\n Patients who have again become acutely ill following recent treatment and achievement of a brief remission of acute TMA may be enrolled in the study if ALL of the following conditions are met: \n\n Disease activity in the patient in unabated (e.g. persistent thrombocytopenia and microangiopathic hemolytic anemia with ongoing neurological symptoms and/or troponin elevation); \n\n The last plasma exchange of the patient's preceding course of treatment occurred at least 7 days prior; \n\n The patient did not undergo splenectomy during the preceding course of treatment; \n\n The new course of plasma exchange has not been ongoing for more than 3 days. \n\n ", - "exclusion_criteria": ": \n\n Females: pregnant or <24 hours post-partum, or breastfeeding; \n\n History of bleeding diathesis or evidence of active abnormal bleeding within the previous 30 days; \n\n Disseminated malignancy or other co-morbid illness limiting life expectancy to \u22643 months independent of the TMA disorder. \n\n Diagnosis other than TMA which can account for the findings of thrombocytopenia and hemolytic anemia (e.g., DIC, HELLP syndrome, Evans syndrome); \n\n Diagnosis of DIC verified by laboratory values for D-dimer, fibrinogen, prothrombin time (PT), and activated partial thromboplastin time (aPTT). \n\n Patients who have again become acutely ill following recent treatment and achievement of a brief remission of acute TMA may not be enrolled in the study if ANY of the following conditions are met: \n\n The last plasma exchange of the patient's preceding course of treatment occurred less than 7 days prior; \n\n The patient underwent splenectomy during the preceding course of treatment; \n\n The new course of plasma exchange has been ongoing for more than 3 days.", - "brief_summary": "The purpose of this ascending-dose research study is to determine whether the administration of ARC1779 Injection improves subject's health profile by protecting the brain, heart, and kidney from damage due to formation of small blood clots in blood vessels. It will also determine the safety of ARC1779 Injection, how ARC1779 Injection enters and leaves the blood and tissue over time, and its effect on laboratory tests related to blood clotting, heart and brain function, and other body systems.", - "NCTID": "NCT00726544" - }, - { - "brief_title": "Functional Outcome After Incisional Hernia Repair: Open Versus Laparoscopic Repair", - "phase": "Phase 4", - "drugs": "['Laparoscopic repair', 'Open midline incisional hernia repair']", - "drugs_list": [ - "Laparoscopic repair", - "Open midline incisional hernia repair" - ], - "diseases": "['Hernia, Ventral', 'Body Image', 'Respiratory Function Tests', 'Quality of Life', 'Laparoscopy']", - "diseases_list": [ - "Hernia", - "Ventral", - "Body Image", - "Respiratory Function Tests", - "Quality of Life", - "Laparoscopy" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Informed consent \n\n Age 18 years or older \n\n Diagnosis of reducible incisional hernias up to 200 cm\u00b2 \n\n Medically fit for general anesthesia \n\n Comprehension and use of French language \n\n Installed in the geographical region without foreseeable move for two years \n\n ", - "exclusion_criteria": ": \n\n Incarcerated hernia \n\n Ongoing chronic pain syndrome, other than hernia origin \n\n Coagulation disorders, prophylactic or therapeutic anticoagulation, unable to stop platelet antiaggregation therapy 10 days before surgery \n\n American Society of Anesthesiology Class 4 and 5 patients \n\n Emergency surgery, peritonitis, bowel obstruction, strangulation, perforation \n\n Mentally ill patients \n\n Presence of local or systemic infection \n\n Life expectancy < 2 years \n\n Any cognitive impairment (Psychiatric disorder, Alzheimer's disease etc.) \n\n Morbid obesity (BMI over 40)", - "brief_summary": "Background: Midline incisional hernia is reported from 0,5 to 11% after abdominal operations. Primary repair without mesh reinforcement is almost abandoned because of high recurrence rates (24 to 46%). Use of prosthetic mesh in incisional hernia repair lowered the recurrence rates under 10%. Recurrence rate alone is not the main quality criterion for incisional hernia repair anymore. Large series and meta-analyses confirmed the value of laparoscopic repair as at least equal if not better compared with open repair. Discomfort, pain, diminished quality of life and body image alteration influences functional well being. No baseline information exists in any of these fields treating pre- or post-operative phases in patients with incisional hernia. Respiratory functions and medico-economic evaluation are other rarely investigated fields that we consider in our trial. The objective of this study is to analyse the functional outcome status of patients after laparoscopic incisional hernia repair compared to open repair.~Methods: A randomized controlled non-blinded clinical trial is designed to compare laparoscopic incisional hernia mesh repair with open repair on post operative pain, health related quality of life outcomes, body image and cosmetic measurements, respiratory functions, recurrence rates, and cost. Volunteers will be recruited in Geneva University Hospital, department of surgery, visceral surgery unit. Eligibility criteria is male patient aged over 18 years, with reducible incisional hernia who are candidates for elective surgery and medically fit for general anesthesia.30 patients will be enrolled for each group. Follow-up will take place at 10th, 30th days as well as 3 12 and 24 post operative months by questionnaires and by clinical exam by independent expert. An overall cost-analysis will be realized. Patient enrollment in the study will start in April 2008 and estimated to end in september 2009.", - "NCTID": "NCT00625053" - }, - { - "brief_title": "Nebulized Analgesia for Laparoscopic Appendectomy Trial", - "phase": "Phase 1; Phase 2", - "drugs": "['Ropivacaine', 'Normal saline']", - "drugs_list": [ - "Ropivacaine", - "Normal saline" - ], - "diseases": "['Appendicitis']", - "diseases_list": [ - "Appendicitis" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Children and adolescents aged 7-18 years old \n\n ASA Score I (American Society of Anesthesiologists classification) [Appendix 1]: a normal healthy patient. \n\n ASA Score II (American Society of Anesthesiologists classification): A patient with mild systemic disease \n\n Patients scheduled for laparoscopic appendectomy surgery \n\n Uncomplicated appendicitis \n\n Hemodynamically stable patient \n\n No evidence of appendiceal perforation based on preoperative clinical and imaging assessment \n\n Diagnosed to have simple acute appendicitis by intraoperative laparoscopy \n\n Patients who have provided a written informed assent \n\n Caregivers who have provided a written informed consent \n\n ", - "exclusion_criteria": ": \n\n ASA Score III (American Society of Anesthesiologists classification): A patient with severe systemic disease \n\n ASA Score IV (American Society of Anesthesiologists classification): A patient with severe systemic disease that is a constant threat to life \n\n ASA Score V (American Society of Anesthesiologists classification): A moribund patient who is not expected to survive without the operation \n\n Hemodynamically unstable patient \n\n Evidence of appendiceal perforation on based on preoperative clinical and imaging assessment \n\n Perforated or gangrenous appendicitis diagnosed during laparoscopic surgery \n\n Postoperative admission in an intensive care unit with sedation or ventilatory assistance \n\n Cognitive impairment or mental retardation \n\n Progressive degenerative diseases of the CNS \n\n Seizures or chronic therapy with antiepileptic drugs \n\n Severe hepatic or renal impairment \n\n Allergy to one of the specific drugs under study \n\n Alcohol or drug addiction \n\n Failure to successfully undergo a laparoscopic appendectomy \n\n A significant communication problem including language barrier, precluding phone follow up \n\n Participation in a concomitant research study \n\n Inability to assure complete follow up \n\n Failure to acquire informed consent and assent", - "brief_summary": "The objective of this study is to assess whether the administration of nebulized intra-peritoneal ropivacaine at the onset of surgery, compared with nebulized saline, reduces morphine consumption after laparoscopic appendectomy surgery in children and adolescents.", - "NCTID": "NCT02624089" - }, - { - "brief_title": "A Phase II Non-Controlled, Open-Label, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Pacritinib in Myelofibrosis", - "phase": "Phase 2", - "drugs": "['Pacritinib']", - "drugs_list": [ - "Pacritinib" - ], - "diseases": "['Primary Myelofibrosis']", - "diseases_list": [ - "Primary Myelofibrosis" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Intermediate-1, intermediate-2, or high-risk PMF, PPV-MF or PET-MF as based on The Dynamic International Prognostic Scoring System (DIPSS) criteria \n\n Palpable splenomegaly \u22655 cm below the LCM in midclavicular line by physical examination \n\n TSS \u226513 on the MPN-SAF TSS 2.0, not including the inactivity question, based on a single assessment during screening visit \n\n Age \u226518 years old at the time of screening (or minimum age of legal consent consistent with local regulations, if minimum is >18 years of age) \n\n ECOG performance status 0 to 3 \n\n Peripheral blast count <10% \n\n Absolute neutrophil count >500/\u03bcL \n\n Participants who are platelet or RBC transfusion dependent are eligible \n\n Adequate liver and renal function, defined by liver transaminases (AST/serum glutamic oxaloacetic transaminase [SOOT] and alanine aminotransferase [ALT]/serum glutamic pyruvic transaminase [SGPT]) \u22643 \u00d7 upper limit of normal ([ULN], AST/ALT \u22645 \u00d7 ULN if transaminase elevation is related to MF), direct bilirubin \u22644 \u00d7 ULN, and creatinine \u22642.5 mg/dL \n\n At least 6 months from prior splenic irradiation \n\n At least 12 months from prior 32P therapy \n\n At least 1 week since prior treatment (most recent dose) with a potent CYP3A4 inhibitor or inducer \n\n At least 4 weeks since any experimental treatment for PMF, PPV-MF, or PET-MF \n\n At least 2 weeks since any treatment for PMF, PPV-MF, or PET-MF \n\n If fertile, both males and females must agree to use effective birth control. \n\n Able to understand and willing to complete symptom assessments using a patient-reported outcomes instrument and comply with treatment and study procedures of the protocol \n\n Able to understand and willing to sign the informed consent form (ICF) \n\n Participant is willing and able to comply with the requirements of the protocol \n\n ", - "exclusion_criteria": ": \n\n Any GI or metabolic condition that could interfere with absorption of oral medication \n\n Life expectancy <6 months \n\n Prior treatment with a JAK2 inhibitor \n\n Completed ASCT, or are eligible for and willing to complete ASCT \n\n History of splenectomy or planning to undergo splenectomy \n\n Uncontrolled intercurrent illness, including but not limited to ongoing active infection, or psychiatric illness, or social situation that, in the judgment of the treating physician, would limit compliance with study requirements \n\n Other malignancy within the last 3 years, other than curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, organ confined, or treated non-metastatic prostate cancer with negative prostate specific antigen, in situ breast carcinoma after complete surgical resection, or superficial transitional cell bladder carcinoma \n\n Inflammatory or chronic functional bowel disorder, such as Crohn's disease, inflammatory bowel disease, chronic diarrhea, or constipation \n\n Clinically symptomatic and uncontrolled cardiovascular disease \n\n History of any of the following within 6 months prior to first dose of pacritinib: myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure \n\n New York Heart Association Class II, III, or IV congestive heart failure \n\n Participants with NCI CTCAE (version 4.03) Grade 2 cardiac arrhythmias may be considered for inclusion, with the approval of the medical monitor, if the arrhythmias are stable, asymptomatic and unlikely to affect participant safety. Participants will be excluded if they have ongoing cardiac dysrhythmias of NCI CTCAE Grade \u22653, QTc prolongation >450 ms, or other conditions that increase the risk for QT interval prolongation (eg, heart failure, hypokalemia [defined as serum potassium <3.0 mEq/L that is persistent and refractory to correction], or family history of long QT interval syndrome) \n\n Erythropoietic agent within 28 days prior to first dose of pacritinib \n\n Thrombopoietic agent within 14 days prior to first dose of pacritinib \n\n Known seropositivity for human immunodeficiency virus or syphilis, or known active hepatitis A, B or C virus infection \n\n Participant has participated in another clinical study involving an IP or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study \n\n Participant is a family member or employee of the investigator \n\n If female, participant is pregnant or breastfeeding at the time of enrollment. Even if breastfeeding can be discontinued, the participant should not be enrolled in the study", - "brief_summary": "To evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of pacritinib in Asian subjects with myelofibrosis (MF), which includes primary MF (PMF), post-polycythemia vera MF (PPV-MF) or post-essential thrombocythemia MF (PET-MF).", - "NCTID": "NCT02584777" - }, - { - "brief_title": "Impact of Cranioplasty On Cerebral Perfusion", - "phase": "", - "drugs": "['Cerebral perfusion evaluation']", - "drugs_list": [ - "Cerebral perfusion evaluation" - ], - "diseases": "['Head Injuries', 'Subarachnoid Haemorrhage', 'Intra-cerebral Haemorrhage', 'Cerebral Thrombosis', 'Infarction, Middle Cerebral Artery']", - "diseases_list": [ - "Head Injuries", - "Subarachnoid Haemorrhage", - "Intra-cerebral Haemorrhage", - "Cerebral Thrombosis", - "Infarction", - "Middle Cerebral Artery" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients over 18 years of age up to 65 years \n\n Patients receiving a decompressive craniectomy for : severe head injuries, Subarachnoid hemorrhage, intra-cerebral hemorrhage, cerebral dural sinus thrombosis, malignant middle cerebral artery stroke and undergoing to reconstructive cranioplasty \n\n Patients informed about the study and giving consent \n\n ", - "exclusion_criteria": ": \n\n Patients being not assisted by the French NHS \n\n Patients allergic to CT contrast products \n\n Pregnant and nursing women", - "brief_summary": "The purpose of this study is to examine the impact of cranioplasty on cerebral hemodynamic and blood flow as prognostic factor in patients receiving decompressive craniectomy for Head injuries, Subarachnoid haemorrhage, intra-cerebral haemorrhage, cerebral dural sinus thrombosis, malignant middle cerebral artery stroke.", - "NCTID": "NCT01113645" - } - ], - "1": [ - { - "brief_title": "Evaluation of Trauma Team Activation Criteria", - "phase": "", - "drugs": "['Trauma team activation']", - "drugs_list": [ - "Trauma team activation" - ], - "diseases": "['Trauma', 'Injuries']", - "diseases_list": [ - "Trauma", - "Injuries" - ], - "enrollment": "324.0", - "inclusion_criteria": "inclusion criteria: \n\n all patients admitted with the trauma team \n\n all patients admitted with Injury Severity Score >15 \n\n ", - "exclusion_criteria": ": \n\n secondary admittance(transfers)>24 post injury", - "brief_summary": "The aim of the study is to establish the predictive properties of our trauma team activation protocol, and its individual criteria, and if possible to suggest changes that reduce over- and undertriage.~The study will also give an overview of the frequency and type of emergency procedures at a university hospital trauma center, which can contribute to optimal resource use and indicate which type of surgical skills are necessary in our trauma emergency procedures.", - "NCTID": "NCT01771861" - } - ], - "2": [ - { - "brief_title": "Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients", - "phase": "Phase 2", - "drugs": "['Pneumovax-23']", - "drugs_list": [ - "Pneumovax-23" - ], - "diseases": "['Asplenia']", - "diseases_list": [ - "Asplenia" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult trauma patients (aged 18 to 65 years old) sustaining a splenic injury. \n\n ", - "exclusion_criteria": ": \n\n Ages less than 18 and greater than 65 \n\n Initial planned nonoperative management patient who subsequently undergoes embolization or splenectomy will be withdrawn from the study.", - "brief_summary": "Persons without a spleen are susceptible to potentially lethal infections from certain bacteria, with pneumococcus being the most prevalent. Vaccines are provided to help protect against these infections, though they do not so with certainty. Trauma patients who sustain an injury to their spleen currently have three treatment options available for the treating surgeon - nonoperative management, embolization, or removal of the spleen. The purpose of this study is to investigate the antibody response to pneumococcal vaccine in patients undergoing these modes of therapy.", - "NCTID": "NCT02232191" - }, - { - "brief_title": "Different Fluidic Strategy in Patients With Acute Abdomen : The Sure Volume", - "phase": "Phase 2", - "drugs": "['Standard fluidic resuscitation.', 'Volemic small treatment']", - "drugs_list": [ - "Standard fluidic resuscitation.", - "Volemic small treatment" - ], - "diseases": "['Acute Abdomen']", - "diseases_list": [ - "Acute Abdomen" - ], - "enrollment": "99.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients with acute abdomen undergoing abdominal surgery under emergency and presenting on arrival in ICU at least a sign of bad perfusion. \n\n ", - "exclusion_criteria": ": \n\n Patients with chronic renal failure already receiving dialysis treatment \n\n Acute Coronary Syndrome (ACS) <12 months and New York Hearth Classification (NHYA ) class > 3 \n\n Patients judged at the admission not subject to resuscitative measures for severity and comorbidity \n\n Patients with massive hemorrhage in operative room or in the immediate perioperative with the need for blood transfusions and abundant blood products > 5 units of Erytrocyte Concentrates (EC) \n\n Patients scheduled for Orthotopic Liver Transplantation (OLT) \n\n Patients younger than 18 years old", - "brief_summary": "Acute abdomen is the clinical manifestation of irritation of the peritoneum, due to intra-abdominal generalized infection. With the exception of the primary ones which are the result of a bacterial translocation from the gastro-intestinal tract or an abdominal contamination for hematogenous way sometimes treatable with medical therapy alone, peritonitis represents a complex condition that requires an early surgical treatment.~Mortality linked to the peritonitis is extremely high and variable between 42% and 80% when associated with a systemic framework of severe sepsis. This variability is linked to a number of risk factors, including advanced age of the patients, the presence of comorbidity, male sex, a poor nutritional status, and a number of re-operations; as well as specific characteristics related to the type of infection, the timing of surgery, the beginning of an appropriate and early antibiotic therapy.The post-operative treatment of the patient with peritonitis significantly affects the outcome of the same. The presence of peritonitis and then the seizure of large volumes of liquids and the possible state of systemic vasodilation induced by the infectious process, provide a framework of hypovolemia. There is a literature that identifies in abdominal trauma damage patient's volemic aggressive resuscitation an element of pejorative outcomes. The purpose of this work is to evaluate the clinical changes determined by a different volemic strategy.", - "NCTID": "NCT01911702" - }, - { - "brief_title": "Single Incision Versus Standard Laparoscopic Splenectomy", - "phase": "", - "drugs": "['Single Incision Splenectomy', 'Laparoscopic Splenectomy']", - "drugs_list": [ - "Single Incision Splenectomy", - "Laparoscopic Splenectomy" - ], - "diseases": "['Hereditary Spherocytosis', 'Idiopathic Thrombocytopenic Purpura']", - "diseases_list": [ - "Hereditary Spherocytosis", - "Idiopathic Thrombocytopenic Purpura" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Need for splenectomy \n\n ", - "exclusion_criteria": ": \n\n Splenomegaly", - "brief_summary": "This is a prospective trial of single incision versus standard 4-port laparoscopic splenectomy.~The hypothesis is that there may be a difference in wound infection rates, operative time, doses of analgesics post-operatively, and patient/parent perception of scars. However, the technical difficulty is considerable and the primary outcome is operative time which will be expressed in minutes.", - "NCTID": "NCT01276561" - }, - { - "brief_title": "Biomarkers in Acute Abdomen", - "phase": "", - "drugs": "['No intervention as observational study']", - "drugs_list": [ - "No intervention as observational study" - ], - "diseases": "['Acute Abdominal Pain']", - "diseases_list": [ - "Acute Abdominal Pain" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Presentation at ED with acute abdominal pain, aged at least 18 years \n\n ", - "exclusion_criteria": ": \n\n No informed consent, pregnancy, homeless, no social assurance", - "brief_summary": "Background: In the emergency setting, acute abdominal pain is a diagnostic challenge, as pain is a subjective measure, and serious causes needing surgical intervention do not always meet the clinical picture. Biomarkers measuring the individual stress or pain level may aid in identifying surgical emergencies, but there are many influencing factors that have to be taken into account.~Objective: To evaluate defined stress biomarkers for their diagnostic and prognostic utility in measuring pain, and to evaluate potential influencing or confounding factors.~Design: Prospective observational study in 200 patients presenting to the emergency department with acute abdominal pain.~Estimated duration: May 2015 - May 2016 Location Setting: Emergency Department (ED) of the H\u00f4pital Universitaire Piti\u00e9-Salp\u00e9tri\u00e8re, Paris, France.~Study population: 200 patients presenting to the ED with acute abdomen~Eligibility criteria:~Inclusion criteria: Presentation at ED with acute abdominal pain, aged at least 18 years~Exclusion criteria: no informed consent, pregnancy, homeless, no social assurance~Procedure:~Patients presenting to the ED with acute abdominal pain will be included after informed consent is given. Blood and saliva samples will be drawn initially and after 4 hours, and baseline data assessed. All diagnostic procedures results and diagnosis made by the treating physicians as well as initiated treatment will be recorded Final diagnosis and outcome will be assessed by 2-week-telephone interview.~Measurement of candidate biomarkers will be performed in collected material. Copeptin and SAA will be measured as potential biomarkers, as a control value, cortisol will be obtained. Other biomarkers will be in consideration, depending upon availability and financial aspects.~Safety evaluations: All recommendations outlined in the ICH Guidelines for Good Clinical Practice will be adhered to throughout this trial.~Sample size considerations: The number of patients of this pilote study is based on the estimate of 25 % or 50 of acute abdomen patients to have a surgical emergency.~Significance of the study: If a biomarker is found that safely discriminates between surgical urgency and harmless abdominal pain, this will spare radiologic exposure in often young patients and will aid in optimized allocation of health care resources.", - "NCTID": "NCT02399150" - }, - { - "brief_title": "The Effect of Different Types of Temporary Abdominal Closure on Intra Abdominal Hypertension.", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Intra Abdominal Hypertension', 'Abdominal Compartment Syndrome']", - "diseases_list": [ - "Intra Abdominal Hypertension", - "Abdominal Compartment Syndrome" - ], - "enrollment": "42.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults male or female over 18 year old undergoing emergency laparotomy. Patients that have their abdominal wall closed at the end of surgery by a temporary closure technique. \n\n ", - "exclusion_criteria": ": \n\n Patients that according to the surgeon estimates will not survive 24 hours.", - "brief_summary": "This is a prospective comparison trial. Patients that will be included in the trial are those that will have operations in which their abdominal closure is temporary, i.e. patients sustaining trauma or septic abdomen.~Patients will be grouped according to the method of temporarily abdominal closure (TAC) procedure:~Vacuum-assisted closure (VAC)~Bogota bag (BB), a sterile intravenous bag silo closure. The two methods are currently accepted with no clear cut evidence to prefer one on another. At Soroka Medical Center the decision to choose either of the methods is at the surgeon's discretion.~Intra-abdominal pressure will be measured in all patients by the urinary bladder pressure technique at 6 12 24 ant 48 hours post operation. The measurement is a routine procedure done as part of the monitoring processes of critically ill patients in the General Intensive Care Unit (GICU).~Patients will be evaluated for the development of acute intra abdominal hypertension with or without abdominal compartment syndrome.", - "NCTID": "NCT02229695" - } - ] - }, - { - "patient_id": "sigir-201425", - "patient": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", - "0": [ - { - "brief_title": "Risk Factors of Minor Head Injury", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Minor Head Injury', 'Intracranial Bleeding', 'Traumatic Brain Injury']", - "diseases_list": [ - "Minor Head Injury", - "Intracranial Bleeding", - "Traumatic Brain Injury" - ], - "enrollment": "12500.0", - "inclusion_criteria": "inclusion criteria: \n\n Minor head injury, dizziness, nausea, vomiting \n\n ", - "exclusion_criteria": ": \n\n no injury to the head", - "brief_summary": "Introduction and Aims:~The objective of this prospective study is to evaluate the risk factors of minor head injury in all consecutive patients of one year.", - "NCTID": "NCT00451789" - }, - { - "brief_title": "Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury", - "phase": "Phase 3", - "drugs": "['Hypothermia']", - "drugs_list": [ - "Hypothermia" - ], - "diseases": "['Traumatic Brain Injury']", - "diseases_list": [ - "Traumatic Brain Injury" - ], - "enrollment": "232.0", - "inclusion_criteria": "inclusion criteria: \n\n Non-penetrating brain injury with post-resuscitation Glasgow Coma Score (GCS) < 8 (motor 1-5) \n\n Estimated or known age > 16 and < 45 years old \n\n Time of Injury within 2.5hrs of arrival at hospital \n\n ", - "exclusion_criteria": ": \n\n GCS = 7 or 8 with a normal head Cat Scan (CT) scan or showing only mild Subarachnoid hemorrhage (SAH)or skull fracture or GCS > 9 post- randomization \n\n GCS = 3 AND bilaterally non-reactive pupils \n\n Abbreviated Injury Score (AIS) > 4 for any body area except head \n\n Positive abdominal ultrasound or CT scan \n\n Persistent hypotension (systolic blood pressure < 110mmHGg) \n\n Persistent hypoxia (O2 Saturation < 94%) \n\n Positive pregnancy test \n\n Injured greater than 2.5 hours from hospital arrival \n\n Pre-existing medical conditions, if known", - "brief_summary": "Induction of hypothermia to < 35\u02daC by < 2.5 hours after severe traumatic brain injury, reaching 33\u02daC by 4 hours after injury and maintained for 48 hours in patients aged 16-45 will result in an increased number of patients with good outcomes at six months after injury compared to patients randomized to normothermia.", - "NCTID": "NCT00178711" - }, - { - "brief_title": "Intensive Monitoring of Brain Injured Patients", - "phase": "", - "drugs": "['Brain oxygenation and microdialysis catheters']", - "drugs_list": [ - "Brain oxygenation and microdialysis catheters" - ], - "diseases": "['Traumatic Brain Injury']", - "diseases_list": [ - "Traumatic Brain Injury" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Traumatic Brain Injury with a Glascow Coma Score < 9 (ie: severe head injury) \n\n Traumatic Brain Injury with a Glascow Coma Score > 8 with an intracranial pressure monitor in situ and CTscan evidence of one or more of the following: Cerebral oedema (Marshall grades III & IV), midline shift >5 mm cerebral contusion >3cm, evacuated subdural haematoma \n\n Enrolled within the first 48 hours after trauma \n\n Aged 17- 70years \n\n ", - "exclusion_criteria": ": \n\n Has had a cardiac arrest at or post the trauma scene \n\n Pupils are fixed bilaterally and dilated >4mm,GCS=3 \n\n Coagulopathy sufficient to contraindicate surgery \n\n No chance of survival after consideration of CT and clinical findings \n\n Patients with lower limb/pelvic trauma excluded from Innercool monitoring only", - "brief_summary": "Analysis of cerebral blood flow (CBF) and oxygenation using complementary focal and global monitoring techniques will permit the delivery of more informed individualised and 'targeted' therapy on the patient with severe head injury, reduce episodes of secondary brain injury and therefore improve outcomes.~Aims~To develop a deeper understanding of Cerebral Blood Flow and auto-regulation for TBI patients based on the results of data collected in patients post TBI.~To establish the basis for further multi modality clinical trials in severely brain injured patients in the future.~To improve understanding of the various secondary processes that continue to cause neuronal damage after the initial injury, and therefore affect patient outcome.~To proceed to the second phase of the study, with the introduction of algorithms for treatment.", - "NCTID": "NCT00163774" - }, - { - "brief_title": "Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury", - "phase": "Phase 1; Phase 2", - "drugs": "['AbelaDrug200', 'mannitol']", - "drugs_list": [ - "AbelaDrug200", - "mannitol" - ], - "diseases": "['Severe Head Trauma']", - "diseases_list": [ - "Severe Head Trauma" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis TBI \n\n GCS 4-8 \n\n Age 16-70 \n\n ", - "exclusion_criteria": ": \n\n Multiple trauma resulting in shock \n\n Bilateral absent pupil response \n\n Time from injury > 6 hours \n\n Brain tumor or mass effect secondary to hemorrhage or brain surgery \n\n Pregnancy \n\n Confounding condition or injury \n\n Spinal cord injury \n\n Sustained high blood pressure or arterial oxygen saturation", - "brief_summary": "This is a randomized, controlled clinical trial at three sites to determine the safety and preliminary efficacy of the study drug to treat severe head trauma (GCS 4-8). It is hypothesized that the drug may lower pressure in the brain, reduce mortality and the patient may have improved neurological function following treatment.", - "NCTID": "NCT00810940" - }, - { - "brief_title": "Concussion and Post Traumatic Stress in Traumatic Brain Injury", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Concussion', 'Stress Disorders, Post-Traumatic']", - "diseases_list": [ - "Concussion", - "Stress Disorders", - "Post-Traumatic" - ], - "enrollment": "1.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients will be recruited from the Bellevue Hospital Emergency Services (Emergency Department and Trauma Bay) or from among inpatient populations at Bellevue Hospital. They will need to be consentable and able/willing to participate and meet criteria for distribution into one of the three subject populations (structural TBI, non-structural TBI, injured/non-TBI) described here: \n\n mild to moderate structural traumatic brain injury (TBI) as evidenced by CT scan demonstrating the presence of hemorrhage (subdural, epidural, subarachnoid or intraparenchymal), brain contusion, or skull fracture. \n\n non-structural TBI(concussion), meaning no signs of structural injury on imaging; however, they complain of usual brain injury symptoms such as headache, dizziness, cognitive impairments, etc., A subject with a traumatically induced physiological disruption of brain function, manifested by >1 of the following: \n\n Any period of loss of consciousness (LOC). \n\n Any loss of memory for events immediately before or after the accident. \n\n Any alteration in mental state at the time of accident (i.e. feeling dazed, disoriented, or confused). \n\n Focal neurological deficit(s) that may or may not be transient, but where the severity of the injury does not exceed the following: \n\n Loss of consciousness of approximately 30 minutes or less \n\n After 30 minutes, an initial Glasgow Coma Scale (GCS) of 13-15 \n\n Posttraumatic amnesia (PTA) not greater than 24 hours. \n\n Non-brain injured subjects that have suffered some type of injury such as to the extremities or other parts of the body. The subjects will have sustained a blunt or penetrating trauma such as, to the corpus or extremities (i.e. car accident, falling). \n\n ", - "exclusion_criteria": ": \n\n Subjects that receive minor penetrating trauma insufficiently traumatizing to result in sufficient sequelae will be excluded. \n\n Subjects suffering burns, anoxic injury or multiple/extensive injuries resulting in any medical, surgical or hemodynamic instability will also be excluded. \n\n Particularly for the purposes of eye tracking all subjects that are blind (no light perception), are missing eyes, do not open eyes will be excluded from the research. \n\n It is pertinent that subjects be able to detect light and have both eyes in order for the eye tracking data to be effective and significant. \n\n Any physical or mental injury or baseline disability rendering task completion difficult will be excluded, also inability to participate in longtitudinal care, or obvious intoxication or blood alcohol level greater than 0.2. \n\n Pregnant individuals and prisoners will also be excluded from the study.", - "brief_summary": "Mild brain injury or concussion affects about four million Americans each year. Some people recover completely while others, especially those with multiple concussions, develop chronic headaches, neurodegenerative diseases and psychiatric disorders. One of the reasons that concussion is difficult to treat is that it is difficult to detect. Radiographic studies such as CT (computed tomography scan) are by definition unrevealing of structural injury in concussed patients. Some MRI (magnetic resonance imaging) sequences may be useful adjuncts in the diagnosis of concussion but even these are not consistently present in all patients with symptoms. Clinical tests for concussion often require baseline studies, and thus are generally reserved for athletes and others at highest risk for concussion.~The investigators have developed a novel eye movement tracking algorithm performed while subjects watch television or a music video that determines whether the eyes are moving together (conjugate) or are subtly not together (disconjugate). The investigators preliminary data shows that people with lesions in their brain or recovering from brain injury have disconjugate gaze that is not detectable by ophthalmologic examination but is detected by our algorithm.", - "NCTID": "NCT02119533" - }, - { - "brief_title": "The Value of the Canadian CT Head Rule and the New Orleans Criteria in Minor Head Trauma", - "phase": "", - "drugs": "['no intervention', 'no intervention']", - "drugs_list": [ - "no intervention", - "no intervention" - ], - "diseases": "['Minor Head Injury']", - "diseases_list": [ - "Minor Head Injury" - ], - "enrollment": "1600.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient with acute MHI was defined as a patient having a blunt trauma to the head within 24 hours with a Glasgow Coma Scale (GCS) of 13 to 15 and at least 1 of the following risk factors: history of loss of consciousness, short-term memory deficit, amnesia for the traumatic event, post-traumatic seizure, vomiting, headache, external evidence of injury above the clavicles, confusion, and neurologic deficit. \n\n ", - "exclusion_criteria": ": \n\n Patients are excluded from the study if they are younger than 10 years, had GCS score of less than 13 or instable vital signs, came to the ED more than 24 hours after head trauma, were pregnant, were taking warfarin or had bleeding disorder, had an obvious penetrating skull injury or had contraindications for CT.", - "brief_summary": "The New Orleans Criteria (NOC) and the Canadian CT Head Rules (CCHR) have been developed to decrease the number of normal computed tomography (CT) in mild head injury (MHI). The aim is to compare the clinical performance of these 2 decision rules for indentifying patients with intracranial traumatic lesions and those who required an emergent neurosurgical intervention following MHI.", - "NCTID": "NCT01619943" - }, - { - "brief_title": "Study of Oxycyte in Severe Closed Head Injury", - "phase": "Phase 2", - "drugs": "['perfluorocarbon emulsion (Oxycyte) infusion']", - "drugs_list": [ - "perfluorocarbon emulsion (Oxycyte) infusion" - ], - "diseases": "['Traumatic Brain Injury']", - "diseases_list": [ - "Traumatic Brain Injury" - ], - "enrollment": "9.0", - "inclusion_criteria": "inclusion criteria: \n\n severe closed head injury patients or GCS 3-9 patients who receive brain oxygen monitoring \n\n ventriculostomy/ICP monitor \n\n at least one reactive pupil \n\n no known life threatening disease prior to trauma \n\n age 18-70 years old \n\n consent for microdialysis/brain 02 monitoring \n\n legal family representative present that can give informed consent for perfluorocarbon administration \n\n ", - "exclusion_criteria": ": \n\n no motor response \n\n both pupils fixed and dilated \n\n no consent available \n\n allergy to egg proteins \n\n coagulopathy \n\n major liver injury \n\n major pulmonary injury", - "brief_summary": "Brain damage as a result of decreased oxygen to the brain is found in 80% of patients that die with severe head injuries. Laboratory studies in animals and clinical trials have shown that increasing oxygen in the brain results in better brain oxygen consumption, less cell death, and better functional outcome. This study will test the hypothesis that Oxycyte is an effective way to increase brain oxygen levels in severe head injury.", - "NCTID": "NCT00174980" - }, - { - "brief_title": "Prospective Memory in Children With Traumatic Brain Injury", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Traumatic Brain Injury']", - "diseases_list": [ - "Traumatic Brain Injury" - ], - "enrollment": "178.0", - "inclusion_criteria": "inclusion criteria \n\n English speaker \n\n Minimum birth weight of 2500 grams (5.5 lbs) and 37 weeks' gestation \n\n Additional inclusion criteria for Children with Traumatic Brain Injury \n\n Head injury resulting in a post-resuscitation Glasgow Coma Scale score of either 13 to 15 or 3 to 8 \n\n No evidence of hypoxic injury \n\n ", - "exclusion_criteria": " \n\n History of epilepsy, mental retardation, or documented evidence of developmental dysfunction \n\n Previous hospitalization for head injury involving loss of consciousness or post-concussional symptoms \n\n History of autism, major psychiatric disorder, or pervasive developmental delay \n\n History of meningitis or encephalitis \n\n History of child abuse \n\n History of chronic or uncontrolled serious physical disorders (cancer, uncontrolled diabetes, cystic fibrosis, etc.) \n\n Note: siblings of participants with TBI or orthopedically-injured comparison children will not be enrolled to maintain the independence of the groups", - "brief_summary": "Prospective memory (PM) is memory to complete future tasks, such as recalling to give a note to someone when you next see them, pick up milk on the way home, or remembering to keep an appointment. This study will evaluate PM in children with traumatic brain injury (TBI).", - "NCTID": "NCT00061399" - }, - { - "brief_title": "Physiologic Mechanisms in Pediatric Traumatic Brain Injury (TBI)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Traumatic Brain Injury']", - "diseases_list": [ - "Traumatic Brain Injury" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n TBI patients admitted to the pediatric intensive care service (PICU)or pediatric progressive care unit \n\n Range in age from birth to 15 years \n\n TBI with a Glasgow Coma Scale of 3-15 \n\n Acoustic window for adequate transcranial doppler (TCD) ultrasound \n\n English or Spanish speaking or understanding parent/legal guardian to consent \n\n Access for a buccal swab for genotyping \n\n ", - "exclusion_criteria": ": \n\n Non-English or Spanish speaking parents/legal guardian \n\n Children with a previously diagnosed neurodevelopmental delay", - "brief_summary": "The aims of this study explore the relationships between cerebral vasospasm, apolipoprotein-E (apo-E) genotype, physiologic symptoms, and neurocognitive outcomes that may either intensify or ameliorate secondary injury, for children with a traumatic brain injury. Exploring the apo-E genotype will help us know if injury response is altered in certain children and will aid in developing interventional approaches.", - "NCTID": "NCT01763892" - }, - { - "brief_title": "Safety and Tolerability of Oxycyte in Patients With Traumatic Brain Injury (TBI)", - "phase": "Phase 2", - "drugs": "['Oxycyte', 'Normal Saline']", - "drugs_list": [ - "Oxycyte", - "Normal Saline" - ], - "diseases": "['Traumatic Brain Injury']", - "diseases_list": [ - "Traumatic Brain Injury" - ], - "enrollment": "18.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female 18 - 70 years of age (inclusive) at the time of study entry \n\n Weight \u226545 kg \n\n Able to begin the infusion of study drug within 12 hours of injury \n\n Evidence of severe non-penetrating traumatic brain injury by clinical evaluation, clinical indication for intracranial pressure (ICP) monitoring, Glasgow Coma Scale (GCS) assessment (4-8 prior to randomization, obtained any time prior to dosing and including patients who deteriorate to severe TBI after arrival in the hospital, not including times when the patient is pharmacologically paralyzed for management or treatment) and with definite anatomic signs of injury on head CT scan (e.g., Marshall Grade II-VI or equivalent) \n\n At least one reactive pupil at screening. Just prior to study drug administration pupil reactivity must be confirmed again. If the patient is in the peri-postoperative period at that time and reactivity is difficult to assess due to small pupil size, the Investigator will determine if the patient is eligible based on clinical presentation. \n\n If a patient, due to his or her injuries is unable to provide written informed consent, then written consent may be obtained by an appropriate surrogate decision maker in accordance with preapproved procedures in compliance with local regulations. \n\n ", - "exclusion_criteria": ": \n\n Patients who meet any of the following criteria will not be included in the study: \n\n Physical Assessment: \n\n Not expected to survive the next 24 hours \n\n Morbidly obese (BMI >40) \n\n Absence of a motor response (not including times when the patient is pharmacologically paralyzed for management or treatment) \n\n Severe unexpected hyperthermia on admission (e.g. >39\u00b0C) \n\n Bilaterally fixed and dilated pupils \n\n Penetrating traumatic brain injury \n\n Major liver, kidney, or cardiac injury requiring operative intervention \n\n Major pulmonary injury, including lung contusion, severe atelectasis, acute respiratory distress syndrome, or acute aspiration pneumonitis \n\n Severe chronic obstructive pulmonary disease (COPD), pulmonary edema, or congestive heart failure in the judgment of the Investigator \n\n Laboratory Values: \n\n Platelet count <100,000/mm3 at screening, prior to transfusion of any platelets \n\n Neutrophil count <1500 /mm3 at screening \n\n In the judgment of the Investigator, any clinically significant prolonged clotting time on INR, prothrombin time (PT) or activated partial thromboplastin time (aPTT), or any other coagulation test performed \n\n One or more of the following liver function test results: Total Bilirubin >2 x upper limit of normal (ULN), ALT >2.5 x ULN, or AST 2.5 > x ULN \n\n Women with a positive pregnancy test or known to be currently breastfeeding at screening \n\n Concomitant Medications: \n\n Known use of immunosuppressive therapy (e.g. TNF inhibitors, methotrexate, cyclosporine, etc.) \n\n Concurrent use of Plavix\u00ae (clopidogrel bisulfate), Pradaxa\u00ae (dabigatran elexilate) or an anti- coagulant other than \u2264100 mg/day aspirin for any condition \n\n Known Medical History: \n\n Immersion injury \n\n Cardiopulmonary resuscitation (chest compression and/or external cardiac shock) required following the current injury \n\n Hemodynamically unstable (e.g., requiring >6L colloid or crystalloid fluid as well as >4 units of packed cells within 4 hours prior to enrollment) \n\n Known or suspected brain tumor \n\n Known severe allergy to any component of Oxycyte or known severe allergy to eggs \n\n Known to be immunocompromised (e.g. known history of HIV) \n\n Known history of major liver disease (e.g., liver failure, necrosis or cirrhosis) or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection \n\n Any known hematological or coagulopathic disorder that, in the Investigator's opinion, is likely to significantly impair platelet function or coagulation (e.g., hemophilia, von Willebrand's disease, myelodysplastic syndrome) \n\n History of severe TBI (previous to the current TBI) or any prior cerebral injury that required hospitalization and that may, in the Investigator's opinion, interfere with the results of this study \n\n Known history of any of the following diseases: Parkinson's disease, Huntington's disease, major stroke, seizure disorder, multiple sclerosis or cerebral aneurysm (unless clipped and stable, in which case patient may be included) \n\n Any life threatening condition prior to the current injury or other diseases or disorders that, in the Investigator's opinion, may put the patient at undue risk or confound the results of the study (e.g signs of soft tissue or other active infection) \n\n Current participation in another clinical trial with an investigational product, or participation in such a clinical trial within 30 days prior to screening \n\n Patients serving in the military forces at the time of screening who (if required) do not have the necessary approval from the appropriate authorities", - "brief_summary": "The primary objective of this study is to evaluate the safety and tolerability of a single administration of Oxycyte in patients with severe non-penetrating traumatic brain injury (TBI).~In the first dose level (Cohort 1), 11 patients were randomized 2:1 to receive either 1.0 mL/kg Oxycyte (0.6 g/kg; n=8) or NS (n=3). A total of 8 patients received Oxycyte. The Data Safety Monitoring Board (DSMB) reviewed the safety data for patients in Cohort 1 through Day 14, and approved escalation to the next dose.~In Cohort 2, 18 patients will be randomized 2:1 to receive either 2.0 mL/kg Oxycyte (1.2 g/kg; n=12) or NS (n=6). The DSMB will then review the safety data for all patients in Cohort 2 through Day 14 and either approve escalation to the highest dose or remain at the current dose. If remaining at the current dose level (Cohort 2) an additional 50 patients will be randomized 1:1 to Oxycyte (n=25) or NS (n=25) and treated.~If escalation occurs to Cohort 3, 18 patients would be randomized 2:1 to Oxycyte (n=12) or NS (n=6) to receive the 3.0 mL/kg dose. The DSMB would again review the safety data and decide whether to treat an additional 50 patients at this dose or to decrease the dose back to 2.0 mL/kg. This group would be randomized 1:1 to receive Oxycyte (n=25) or NS.", - "NCTID": "NCT00908063" - }, - { - "brief_title": "Hypothermia to Treat Severe Brain Injury", - "phase": "", - "drugs": "['hypothermia (body temperature lowered to 33\u00b0C or 91.4\u00b0F)']", - "drugs_list": [ - "hypothermia (body temperature lowered to 33\u00b0C or 91.4\u00b0F)" - ], - "diseases": "['Brain Injuries', 'Hypothermia']", - "diseases_list": [ - "Brain Injuries", - "Hypothermia" - ], - "enrollment": "42.0", - "inclusion_criteria": "ELIGIBILITY CRITERIA FOR EARLY COOLING TO 35\u00b0C: \n\n inclusion criteria: \n\n GCS 3-8 on initial evaluation or deteriorates during transport \n\n Mechanism of injury consistent with blunt, non-penetrating trauma to head \n\n Systolic blood pressure > 110 mm Hg \n\n Diastolic blood pressure> 60 mm Hg \n\n Heart rate (pulse) < 120 beats per minute \n\n Estimated or known age 16-45 \n\n No suspicion of pregnancy \n\n Esophageal/rectal probe temperature > 35.5\u00b0C (Pre-hospital cooling only) \n\n Injured < 2 hours prior to arrival of pre-hospital providers \n\n No evidence of severe chest trauma (unilaterally absent breath sounds with tracheal deviation or distended neck veins or requiring thoracentesis). \n\n ", - "exclusion_criteria": ": \n\n Following commands upon EMS arrival without deterioration to coma or follows command after an initial period of coma. \n\n Mechanism of injury GSW or no indication of head injury \n\n Systolic blood pressure < 120 mm Hg \n\n Diastolic blood pressure < 60 mm Hg \n\n Heart rate (pulse) > 120 beats per minute \n\n Estimated or know age > 45 or < 16 \n\n Suspected pregnancy \n\n Forehead scan temp < 35.5\u00b0C (Pre-hospital cooling only) \n\n Injured >2 hours prior to arrival of pre-hospital providers \n\n Evidence of major chest trauma (unilaterally absent breath sounds with tracheal deviation or distended neck veins or requiring thoracentesis. \n\n ELIGIBILITY CRITERIA FOR 48 HOURS OF MODERATE HYPOTHERMIA (33\u00b0C): \n\n inclusion criteria: \n\n Non-penetrating brain injury with a post-resuscitation Glasgow Coma Score < 8 (motor 1-5). \n\n ", - "brief_summary": "The purpose of this trial is to determine if hypothermia (body cooling), administered very soon after a severe brain injury improves functional outcome. This pilot trial ended in July 2005. Please see clinicaltrials.gov record number NCT00178711 for the Phase III version of the trial (see link below).", - "NCTID": "NCT00040339" - }, - { - "brief_title": "The Head Injury-associated Photosensitivity and Pupillary Function (HIPP) Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Head Injury', 'Traumatic Brain Injury (TBI)', 'Photosensitivity', 'Photophobia']", - "diseases_list": [ - "Head Injury", - "Traumatic Brain Injury (TBI)", - "Photosensitivity", - "Photophobia" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n 18+ years old \n\n reports a previous head injury that occurred at least 6 months ago \n\n score of 2 or 3 (mild TBI) on OSU-TBI ID Survey \n\n best-corrected visual acuity of at least 20/30 in both eyes \n\n reliable visual field \n\n ", - "exclusion_criteria": ": \n\n pregnancy \n\n significant afferent pupillary defect \n\n previous history of neurodegenerative disease \n\n intraocular pressure more than 21 mm Hg \n\n significant visual field defect \n\n active corneal pathology \n\n history of retinal or optic nerve disease \n\n strabismus (eye turn)", - "brief_summary": "After a head injury, many people find that exposure to light causes them increased discomfort. By measuring how the pupil in the eye constricts to flashes of red and blue light, this study will investigate whether this phenomenon is due to a change in the eye's sensitivity to light.", - "NCTID": "NCT01942564" - }, - { - "brief_title": "Prehospital Tranexamic Acid Use for Traumatic Brain Injury", - "phase": "Phase 2", - "drugs": "['1 gram Tranexamic Acid (TXA)', '2 grams TXA', '0.9% Sodium Chloride injectable']", - "drugs_list": [ - "1 gram Tranexamic Acid (TXA)", - "2 grams TXA", - "0.9% Sodium Chloride injectable" - ], - "diseases": "['Traumatic Brain Injury']", - "diseases_list": [ - "Traumatic Brain Injury" - ], - "enrollment": "967.0", - "inclusion_criteria": "inclusion criteria: \n\n Blunt or penetrating traumatic mechanism consistent with traumatic brain injury \n\n Prehospital Glasgow Coma Score (GCS) score \u2264 12 at any time prior to randomization and administration of sedative and/or paralytic agents \n\n Prehospital systolic blood pressure (SBP) \u2265 90 mmHg prior to randomization \n\n Prehospital intravenous (IV) or intraosseous (IO) access \n\n Estimated Age \u2265 15 (or estimated weight > 50 kg if age is unknown) \n\n Emergency Medicine System (EMS) transport to a participating trauma center \n\n ", - "exclusion_criteria": ": \n\n Prehospital GCS=3 with no reactive pupil \n\n Estimated time from injury to hospital arrival > 2 hours \n\n Unknown time of injury - no known reference times to support estimation \n\n Clinical suspicion by EMS of seizure activity or known history of seizures, acute myocardial infarction (MI) or stroke \n\n Cardio-pulmonary resuscitation (CPR) by EMS prior to randomization \n\n Burns > 20% total body surface area (TBSA) \n\n Suspected or known prisoners \n\n Suspected or known pregnancy \n\n Prehospital TXA given prior to randomization \n\n Subjects who have activated the opt-out process when required by the local regulatory board", - "brief_summary": "Primary aim: To determine the efficacy of two dosing regimens of TXA initiated in the prehospital setting in patients with moderate to severe TBI (GCS score \u226412).~Primary hypothesis: The null hypothesis is that random assignment to prehospital administration of TXA in patients with moderate to severe TBI will not change the proportion of patients with a favorable long-term neurologic outcome compared to random assignment to placebo, based on the GOS-E at 6 months.~Secondary aims: To determine differences between TXA and placebo in the following outcomes for patients with moderate to severe TBI treated in the prehospital setting with 2 dosing regimens of TXA:~Clinical outcomes: ICH progression, Marshall and Rotterdam CT classification scores, DRS at discharge and 6 months, GOS-E at discharge, 28-day survival, frequency of neurosurgical interventions, and ventilator-free, ICU-free, and hospital-free days.~Safety outcomes: Development of seizures, cerebral ischemic events, myocardial infarction, deep venous thrombosis, and pulmonary thromboembolism.~Mechanistic outcomes: Alterations in fibrinolysis based on fibrinolytic pathway mediators and degree of clot lysis based on TEG.~Inclusion: Blunt and penetrating traumatic mechanism consistent with TBI with prehospital GCS \u2264 12 prior to administration of sedative and/or paralytic agents, prehospital SBP \u2265 90 mmHg, prehospital intravenous (IV) access, age \u2265 15yrs (or weight \u2265 50kg if age is unknown), EMS transport destination based on standard local practices determined to be a participating trauma center.~Exclusion: Prehospital GCS=3 with no reactive pupil, estimated time from injury to start of study drug bolus dose >2 hours, unknown time of injury, clinical suspicion by EMS of seizure activity, acute MI or stroke or known history, to the extent possible, of seizures, thromboembolic disorders or renal dialysis, CPR by EMS prior to randomization, burns > 20% TBSA, suspected or known prisoners, suspected or known pregnancy, prehospital TXA or other pro-coagulant drug given prior to randomization, subjects who have activated the opt-out process when required by the local regulatory board.~A multi-center double-blind randomized controlled trial with 3 treatment arms:~Bolus/maintenance: 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.~Bolus only: 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.~Placebo: Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.", - "NCTID": "NCT01990768" - }, - { - "brief_title": "Methylphenidate for Attention Problems After Pediatric TBI", - "phase": "Phase 4", - "drugs": "['Methylphenidate', 'Placebo']", - "drugs_list": [ - "Methylphenidate", - "Placebo" - ], - "diseases": "['Traumatic Brain Injury', 'TBI', 'ADHD']", - "diseases_list": [ - "Traumatic Brain Injury", - "TBI", - "ADHD" - ], - "enrollment": "26.0", - "inclusion_criteria": "inclusion criteria: \n\n Between ages of 6-17 \n\n Sustained Moderate to Severe TBI \n\n TBI occurred at least 6 months prior to beginning the study \n\n TBI occurred no earlier than 5 years of age \n\n Positive endorsement of 6 out of 9 items on the Vanderbilt ADHD inattention or hyperactivity scale \n\n ", - "exclusion_criteria": ": \n\n History of developmental disability or mental retardation \n\n Current active participation in ADHD-related behavioral intervention \n\n History of psychiatric condition requiring an inpatient admission in past 12 months \n\n Actively taking medications with a contraindication to Concerta that cannot be discontinued \n\n Current use of stimulant medication or ADHD specific medications that cannot be discontinued \n\n Non-blunt head injury \n\n Family history of arrhythmia \n\n Pregnancy", - "brief_summary": "Traumatic Brain Injury (TBI) - methylphenidate treatment", - "NCTID": "NCT01933217" - }, - { - "brief_title": "Fast MR for Young Children With Traumatic Brain Injury", - "phase": "", - "drugs": "['Fast MR', 'Computed Tomography']", - "drugs_list": [ - "Fast MR", - "Computed Tomography" - ], - "diseases": "['TBI (Traumatic Brain Injury)']", - "diseases_list": [ - "TBI (Traumatic Brain Injury)" - ], - "enrollment": "225.0", - "inclusion_criteria": "inclusion criteria: \n\n Children <72 months old in whom a head CT is ordered/obtained with concerns for TBI \n\n Present to the Children's Hospital Colorado (CHCO) Emergency Department (ED) or inpatient wards \n\n ", - "exclusion_criteria": ": \n\n Contraindication to MR (e.g. pacemaker, implanted metallic object incompatible with MR) \n\n Prior diagnosis of TBI, structural brain lesion or prior brain surgery including shunted hydrocephalus \n\n Prior participation in this study \n\n Clinically unstable in the opinion of the patient's attending physician \n\n Wards of the State \n\n TBI not included in the differential diagnosis of the patient's attending physician (e.g. the indication for imaging is concern for infections, tumor, autoimmune or inflammatory disease) or if imaging has already identified a non-traumatic source for symptoms", - "brief_summary": "This proposal will test the diagnostic utility of fast magnetic resonance (MR) in young children with Traumatic brain Injury (TBI).~In children, TBI causes >2000 deaths, 35,000 hospitalizations and 470,000 emergency department visits in the US each year, making it a leading cause of pediatric disability and death. Currently 20-50% of these children undergo computed tomography (CT) scanning, exposing them to harmful radiation, and increasing their lifetime risk of cancer. Risks are especially increased in children because the neurologic exam is less reliable, because growing tissues are more vulnerable to radiation, and because children have more years to accumulate harmful mutations.~Fast MR is a short, motion-tolerant protocol that has been used in children with shunted hydrocephalus to eliminate radiation exposure without the need for sedation. However, fast MR has not been validated in children with TBI, a critical gap. The investigators will measure feasibility and diagnostic utility of fast MR in children < 6 years (72 months) old who undergo head CT for TBI.~The Investigator will recruit children in whom a head CT is ordered for TBI. Consenting subjects will undergo fast MR shortly after CT and results will be compared to determine: 1) whether fast MR identifies all traumatic injuries identified by CT and 2) whether fast MR without sedation can be performed quickly and successfully.", - "NCTID": "NCT02392975" - }, - { - "brief_title": "Psychological Treatment for Children Suffering From Post Traumatic Stress Symptoms and Mild Traumatic Brain Injury", - "phase": "", - "drugs": "['Prolonged Exposure Therapy']", - "drugs_list": [ - "Prolonged Exposure Therapy" - ], - "diseases": "['PTSD', 'Traumatic Brain Injury', 'Post Concussive Syndrome']", - "diseases_list": [ - "PTSD", - "Traumatic Brain Injury", - "Post Concussive Syndrome" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n For the whole sample: \n\n Children age 6 to 18 \n\n Language spoken: Hebrew, Arabic \n\n DSM- IV R diagnosis: PTSD \n\n Car accident event within past 3 years \n\n For the m-TBI group: \n\n Any of the following symptoms or experiences occurring during or shortly after the accident: loss of consciousness, dazed, confused, saw stars, headache, dizziness, irritability, memory gap (not remembering injury or injury period), visual loss, abdominal pain]. \n\n Diagnosis of MTBI within 3 years as confirmed by CT/MRI/fMRI. \n\n Glasgow coma scale; GCS<15. \n\n ", - "exclusion_criteria": ": \n\n Children presenting with psychotic symptoms \n\n Children presenting with mental retardation", - "brief_summary": "The purpose of this study is to determine whether Prolonged Exposure Therapy (PE)is effective in the treatment of post-traumatic stress symptoms in children and adolescents with mild traumatic brain injury (m-TBI) due to motor vehicle accident.", - "NCTID": "NCT01315379" - }, - { - "brief_title": "To Study the Effect of Early Cooling in Acute Subdural Hematoma Patients", - "phase": "", - "drugs": "['Temperature management Zoll Intravascular Temperature Management device']", - "drugs_list": [ - "Temperature management Zoll Intravascular Temperature Management device" - ], - "diseases": "['Subdural Hematoma, Traumatic']", - "diseases_list": [ - "Subdural Hematoma", - "Traumatic" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n Non-penetrating traumatic brain injury \n\n Glasgow Coma Scale (GCS) motor score \u22645 (not following commands) \n\n Estimated or known age 22-65 years \n\n Acute subdural hematoma requiring emergent craniotomy within 6 hours of initial injury \n\n Estimated time of injury to time to reach temp of 35\u00b0C<6 hrs \n\n ", - "exclusion_criteria": ": \n\n Total GCS = 3 and bilateral fixed and dilated pupils \n\n Following commands after an initial period of coma (GSC motor score of 6) \n\n Known pre-existing neurological deficit (e.g., previous traumatic brain injury (TBI), stroke) \n\n Concomitant spinal cord injury \n\n Arrival temperature is <35\u00b0C \n\n Hemodynamic instability (i.e., mean arterial pressure (MAP)<60 millimetres of mercury (mmHg) for 30 minutes) \n\n Active cardiac dysrhythmia resulting in hemodynamic instability \n\n Pregnancy \n\n Duret hemorrhage \n\n Prisoner or Ward of the State \n\n Known history of clotting disorder (e.g., heparin induced thrombocytopenia, pulmonary embolism/deep venous thrombosis) \n\n Injury to other body organ where hypothermia would be precluded because of bleeding risk (e.g., grade 3 liver laceration; bowel laceration; flail lung or international normalized ratio (INR) >1.4) \n\n Inability to obtain informed consent or utilize exception to informed consent for emergency research.", - "brief_summary": "This randomized, prospective trial will study the effect of very early cooling in patients undergoing surgical evacuation of acute subdural hematomas (35\u00b0C prior to opening the dura followed by maintenance at 33\u00b0C for a minimum of 48h). Intravascular cooling catheters (Thermogard XP Device, Zoll) will be utilized to induce hypothermia or to maintain normothermia.~The primary objective is to determine if rapid induction of hypothermia prior to emergent craniotomy for traumatic subdural hematoma (SDH) will improve outcome as measured by Glasgow Outcome Scale-Extended (GOSE) at 6 months.", - "NCTID": "NCT02064959" - }, - { - "brief_title": "Fibrinogen in the Initial Resuscitation of Severe Trauma (FiiRST)", - "phase": "Phase 1; Phase 2", - "drugs": "['Fibrinogen concentrate', 'Placebo Comparator']", - "drugs_list": [ - "Fibrinogen concentrate", - "Placebo Comparator" - ], - "diseases": "['Trauma', 'Injury', 'Bleeding', 'Haemorrhage', 'Coagulopathy']", - "diseases_list": [ - "Trauma", - "Injury", - "Bleeding", - "Haemorrhage", - "Coagulopathy" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n 1. Injured trauma (penetrating or blunt) patients who are at risk of significant bleeding, defined as: i. Systolic blood pressure (SBP) \u2264 100mmHg at any time from the injury scene until 30min after hospital admission AND ii. Red blood cell transfusion has been ordered by the trauma team leader (or delegate) \n\n ", - "exclusion_criteria": ": \n\n Patients in shock which the etiology is purely not related to bleeding: \n\n i. Cardiogenic (myocardial or valvular dysfunction); ii. Distributive (septic, anaphylactic, acute adrenal insufficiency and neurogenic) and iii. Obstructive (cardiac tamponade, tension pneumothorax and massive pulmonary emboli). \n\n Severe head injury, defined as any of the following: \n\n i. Glasgow coma scale (GCS) of 3 due to severe traumatic brain injury (TBI); ii. TBI with clear indication of immediate neurosurgical intervention based on clinical findings (mechanism of trauma associated with focal signs such as anisocoria with fixed pupil) or on CT results (bleeding causing mass effect); iii. Unsalvageable head injury such as through-through gunshot wound to the head, open skull fracture with exposure/loss of brain tissue; as per the trauma team or neurosurgery initial clinical assessment or as per initial CT of the head findings; \n\n Known complete or incomplete spinal cord injury; \n\n Known hereditary or acquired coagulopathies unrelated to the trauma resuscitation (e.g. known hepatic dysfunction); \n\n Use of anticoagulant medications such as warfarin, low-molecular weight heparin, and direct thrombin and factor Xa inhibitors; \n\n Moribund with evidence of unsalvageable injuries and withdrawal of care, as per the trauma team; \n\n Received blood products prior to admission; \n\n Patients with estimated body weight under 50Kg; \n\n Patients with known or suspected pregnancy; \n\n Patients arriving more than 6hr after injury.", - "brief_summary": "Trauma is the leading cause of death in people 44 years of age or younger. After major trauma, such as following high-speed motor vehicle collision, bleeding coupled with clotting defects is responsible for most of deaths in the first hours of hospital admission. Of note, these bleeding-related deaths are potentially preventable. Accordingly, the initial in-hospital management of severely injured patients focuses on stopping bleeding, replacing blood loss and correcting clotting defects.~Recently, animal and human research demonstrated that one of the major clotting defects following injury and bleeding is the drop in blood levels of fibrinogen (a clotting factor), which is detected on hospital admission in severely injured patients. These low fibrinogen levels are associated with increased blood transfusion and death. However, in North America, the standard of care for replacing low fibrinogen requires the use of cryoprecipitate, which is a frozen blood product with long preparation time, and similarly to other blood products, carries the risk of viral transmission and transfusion complications. Alternately, many Europeans countries where cryoprecipitate has been withdrawn from the market due to safety concerns, use fibrinogen concentrate. Fibrinogen concentrate undergoes pathogen inactivation, which is a process to eliminate the risk of transmitting viruses, bacteria and parasites, is likely a safer and faster alternative to cryoprecipitate. In Canada, fibrinogen concentrate is licensed for congenital low fibrinogen only.~Although preliminary data suggest that fibrinogen supplementation in trauma is associated with reduced bleeding, blood transfusion, and death, the feasibility, safety and efficacy of early fibrinogen replacement remains unknown. We proposed to conduct a feasibility randomized trial to evaluate the use of early fibrinogen concentrate against placebo in injured patients at our trauma centre.~A pilot trial is necessary to demonstrate the feasibility of rapidly preparing, delivering, and infusing fibrinogen concentrate as an early therapy to prevent excessive bleeding in trauma. This feasibility trial will provide preliminary safety and clinical outcome data to inform the design of larger trials; which ultimately aims to prevent bleeding-related deaths in the trauma population.", - "NCTID": "NCT02203968" - }, - { - "brief_title": "Association Between Haptoglobin Genotype and Brain Swelling", - "phase": "", - "drugs": "['Intracerebral Hemorrhage']", - "drugs_list": [ - "Intracerebral Hemorrhage" - ], - "diseases": "['Intracerebral Hemorrhage']", - "diseases_list": [ - "Intracerebral Hemorrhage" - ], - "enrollment": "9.0", - "inclusion_criteria": "inclusion criteria: \n\n Spontaneous intracranial or intraparenchymal hemorrhage \n\n 18-85 years of age \n\n Hemorrhage occurred in a supratentorial location \n\n ", - "exclusion_criteria": ": \n\n Inability to obtain consent within 3 days of hemorrhage onset \n\n Known pregnancy \n\n Therapeutic anticoagulation with Lovenox, Coumadin or Heparin \n\n Prior history of therapeutic radiation to any area \n\n Brain tumor \n\n Hemorrhage related to trauma, aneurysm, arteriovenous malformation or other vascular malformation \n\n Central nervous system infection \n\n Subdural hematoma \n\n Subarachnoid hemorrhage \n\n Chronic immunosuppression, including steroids or chemotherapy agents \n\n Infratentorial location \n\n Unable to obtain MRI due to mental status or other contraindication (metal, pacemaker, etc.)", - "brief_summary": "Intracerebral hemorrhage is bleeding into the brain and is a major cause of stroke and other complications. Brain injury from intracerebral hemorrhage occurs in two phases. The early phase involves the mechanical compression of brain tissue by the expanding hematoma. In a later phase, brain swelling develops causing further compression that may lead to brain herniation and death. This study investigates the neuroprotective role of haptoglobin, in minimizing the development of brain swelling following intracerebral hemorrhage.", - "NCTID": "NCT02054117" - }, - { - "brief_title": "A Comparison of Propofol Versus Midazolam to Sedate Critically Brain Injury; Measurement of Cytokine Response and Assessment of Function", - "phase": "Phase 4", - "drugs": "['Intravenous sedation using propofol', 'Intravenous sedation with midazolam']", - "drugs_list": [ - "Intravenous sedation using propofol", - "Intravenous sedation with midazolam" - ], - "diseases": "['Traumatic Brain Injury']", - "diseases_list": [ - "Traumatic Brain Injury" - ], - "enrollment": "1.0", - "inclusion_criteria": "inclusion criteria: \n\n Ages 18 Years or older \n\n Males or Females \n\n Primary diagnosis of TBI, subarachnoid hemmorhage (SAH), intracranial hemmorhage (ICH), stroke \n\n Requires mechanical ventilation \n\n Requires or is receiving continuous IV sedation \n\n ", - "exclusion_criteria": ": \n\n Glascow Coma Score (GCS) of 3 persisting from the scene with bilaterally fixed dilated pupils with no appreciable chance of survival \n\n The inability to identify a next of kin or guardian to give consent if patient unable to consent \n\n Pregnant \n\n Allergy or contraindication to propofol \n\n Allergy to contraindication to midalozam \n\n Status epilepticus \n\n Current neuromuscular blockade \n\n Patient with a known hypersensitivity to propofol or midalozam \n\n Allergies to eggs, egg products, soybeans or soy products \n\n Acute narrow-angle glaucoma", - "brief_summary": "This is a prospective randomized controlled pilot study in traumatic brain injury (TBI) patients who are sedated with either propofol or midazolam to compare the cytokine response and neuropsychological outcomes with and without elevated blood alcohol levels.~Sedation is part of the standard treatment in patients with a TBI and has been proposed as a neuroprotective intervention in head-injured patients. Sedative regimens, such as midazolam and propofol, are not standardized and it is unclear whether sedation has a significant impact on recovery and outcome. A review of propofol versus midazolam in mechanically ventilated patients shows evidence that both provide effective sedation but there is lack of data to support one sedative over the other.~Cytokines are released in response to tissue injury and act to generate a variety of physiologic responses. The cytokine elevation has been correlated with the extent of tissue injury. This study will compare the cytokine distribution patterns at specific posttraumatic time points in patients with a TBI sedated with either propofol or midazolam. Additional analysis will compare the cytokine response in patients whom had elevated blood alcohol levels with those with normal levels. Neuropsychological testing will also be performed to determine the extent of brain injury and recovery.", - "NCTID": "NCT01712477" - }, - { - "brief_title": "Induced Hypertension for Treatment of Delayed Cerebral Ischaemia After Aneurysmal Subarachnoid Haemorrhage", - "phase": "Phase 3", - "drugs": "['Induced hypertension']", - "drugs_list": [ - "Induced hypertension" - ], - "diseases": "['Cerebral Ischemia', 'Subarachnoid Hemorrhage']", - "diseases_list": [ - "Cerebral Ischemia", - "Subarachnoid Hemorrhage" - ], - "enrollment": "26.0", - "inclusion_criteria": "inclusion criteria for eligibility \n\n Admission to one of the participating study centres. \n\n Age 18 years or over. \n\n SAH with an aneurysmatic bleeding pattern. \n\n ", - "exclusion_criteria": " for eligibility \n\n Evidence of DCI after the SAH, defined as any decrease in the level of consciousness or the development of new focal neurological deficits after the onset of the SAH that is not due to increasing hydrocephalus, rebleeding of the aneurysm, epileptic seizure, septic- or metabolic encephalopathy, unless symptoms of DCI started within 3 hours. \n\n Co-existing severe head injury. \n\n Perimesencephalic haemorrhage (perimesencephalic bleeding pattern and no aneurysm on CT-angiography). \n\n A history of a ventricular cardiac rhythm disorder, necessitating medical treatment. \n\n A history of a left ventricular heart failure, necessitating medical treatment. \n\n Likely transfer to another hospital, not participating in the trial, soon after treatment for the aneurysm. \n\n Moribund. \n\n Pregnancy. \n\n And furthermore, in selected centres where the sub study with CT perfusion will be performed: \n\n Known allergy for CT-contrast agents. \n\n Renal failure, defined as a serum creatinine > 150 \u00b5mol/l, because of the risk of contrast nephropathy. \n\n Diabetes mellitus. \n\n inclusion criteria for trial participation \n\n Informed consent to participate in the proposed trial when DCI will develop. \n\n DCI based on a decrease of at least one point on the Glasgow Coma Scale sum score unless the decrease doesn't reflect DCI as evaluated by the treating physician, and/or the development of new focal neurological deficits, diagnosed by a neurologist, neurosurgeon or intensivist. \n\n ", - "brief_summary": "The objective of this multi-centre, randomized controlled trial is to investigate the outcome after induced hypertension versus no induced hypertension in patients with delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage (SAH), and to assess whether induced hypertension results in improved cerebral blood flow (CBF) as measured by means of perfusion-CT.", - "NCTID": "NCT01613235" - }, - { - "brief_title": "Performance Evaluation of Pupillary Reactivity in Monitoring of Brain-damaged Patients in Intensive Care", - "phase": "", - "drugs": "['pupillometry data']", - "drugs_list": [ - "pupillometry data" - ], - "diseases": "['Brain-damaged Patients']", - "diseases_list": [ - "Brain-damaged Patients" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria: \n\n male or feminine Subjects of 18 or more years old. \n\n Patients c\u00e9r\u00e9bro - hurt presenting disorders(confusions) of the consciousness (Score of Glasgow < 9) and justifying an hourly pupillary surveillance(supervision) in the middle of neurosurgical resuscitation. (Definition of the Score of Glasgow in appendix) \n\n acute(sharp) intellectual Aggression bound(connected) to a cranial trauma, a meningeal bleeding by break of an\u00e9vrysme, a cerebral vascular accident, an intra-cranial expansive process, a post-operative neurosurgical complication, an intra-cranial high blood pressure of medical origin (m\u00e9ningo-encephalitis, hypertensive encephalopathy) \n\n Admission in resuscitation within first 48 hours of the aggression \n\n ", - "exclusion_criteria": ": \n\n Subject having a direct eye trauma, as well as any history which can affect(allocate) the relevance of the pupillary examination (anophthalmia, cataract(waterfall) opalescente, surgery irienne, blindness, reached(affected) by III prerequisite, that the character of these affections is bilateral or unilateral). \n\n presenting Subject of the signs of irreversible coma in the admission. \n\n minor Subject, pregnant or breast-feeding woman, subject deprived of freedom, subject not being affiliated to the national insurance scheme.", - "brief_summary": "The pupillary examination is a major component of the clinical examination and monitoring of brain-damaged patients in intensive care. The occurrence of abnormal size or pupillary reactivity is a prognostic factor of poor neurological outcome or an indicator of the neurological status degradation. To date, the monitoring of the pupils is clinical. The subjectivity of this measure and, the lack of reproducibility and definition of the abnormality remain as many obstacles to the development of a monitoring of early neurological deterioration. The recent development in pupillometer electronics allows the assessment of responsiveness to a calibrated light stimulus. It offers a reliable and reproducible measure of the pupil diameter. The pupillometers were funded by the association of Gueules Cass\u00e9es .~This study aims to establish a relationship between an abnormal pupillary reactivity detection by the electronic pupillometer and a deterioration in neurological status of the patient brain-damaged in the intensive-care unit (ICU). This is considered clinically relevant and has been defined by a lower Glasgow Coma Score of at least 2 points for 2 hours or involving a therapeutic action. If this relationship is demonstrated, the temporal relationship between data pupillometry and the patient's neurological status remain to be established more precisely. This is particularly relevant in neurosurgical context and aim to define the status of the electronic pupillometer in intensive care but also in emergency rooms services, the neurovascular units or in the pre-hospital care.~Therefore the investigators will compare the pupillometry data in two patients groups, defined accordingly to the appearance or absence of neurological aggravation in the first 5 days of treatment in intensive care, time-frame defined as the maximum risk period in patients with brain damage. The primary endpoint is represented by the estimated area under the ROC curve corresponding to the last measure of the change in pupil size before the onset of neurological deterioration and worse for the fifth day for non-aggravated.~Thus the investigators propose to conduct a prospective trial, aiming to record the diagnostic value of pupillary reactivity by the electronic pupillometer in the monitoring of the neurological aggravation of brain damaged patient in ICU. The duration of the follow-up for a subject does not exceed 5 days. The statistical analysis requires the recruitment of 90 patients, which sets the length of the inclusions to 14 months.", - "NCTID": "NCT01796886" - }, - { - "brief_title": "Ketamine/Propofol vs Ketamine Alone for Pediatric Fracture Reduction", - "phase": "Phase 4", - "drugs": "['Ketamine only', 'Ketamine - Propofol']", - "drugs_list": [ - "Ketamine only", - "Ketamine - Propofol" - ], - "diseases": "['Fractures']", - "diseases_list": [ - "Fractures" - ], - "enrollment": "140.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy pediatric emergency patients with isolated extremity injury requiring reduction \n\n ", - "exclusion_criteria": ": \n\n Active respiratory illness \n\n Seizure disorder \n\n Craniofacial abnormalities \n\n Allergy to soy, ketamine, or propofol \n\n Hypertension \n\n Significant renal, cardiovascular or neurologic disease", - "brief_summary": "The objective of this study is to compare Ketamine-Propofol with Ketamine-only in a double-blind, randomised, controlled trial in a paediatric emergency department. We believe that the combination of these two agents will provide a new and more effective option for procedural sedation in paediatric emergency department patients. The hypothesis of the study is that paediatric emergency department patients requiring procedural sedation for an isolated orthopaedic injury with Ketamine-Propofol will have reduced total sedation time, time to recovery, complications and improved satisfaction scores compared to patients receiving Ketamine alone.", - "NCTID": "NCT00490997" - }, - { - "brief_title": "Tranexamic Acid in Chronic Subdural Hematomas", - "phase": "Phase 2; Phase 3", - "drugs": "['Tranexamic Acid', 'Placebo']", - "drugs_list": [ - "Tranexamic Acid", - "Placebo" - ], - "diseases": "['Chronic Subdural Hematoma']", - "diseases_list": [ - "Chronic Subdural Hematoma" - ], - "enrollment": "130.0", - "inclusion_criteria": "inclusion criteria: \n\n CT scan demonstrating the existence of a subdural hematoma containing a chronic component \n\n Diagnosis within the last 14 days \n\n ", - "exclusion_criteria": ": \n\n Acute subdural hematoma with no chronic component; \n\n Active thrombotic, thromboembolic or atheroembolic disease, including deep venous thrombosis within the last six months, cerebral thrombosis within the last six months, symptomatic carotid stenosis who did not undergo surgery or stroke within the last year; \n\n Past history of unprovoked deep venous thrombosis or idiopathic pulmonary embolism; \n\n Known hereditary thrombophilia, including Factor V Leiden, Antithrombin III mutation, Protein C deficiency, Protein S deficiency; \n\n Atrial fibrillation (unless under successful rhythm control therapy); \n\n Metallic heart valve; \n\n Vascular stenting procedure within the last year; \n\n Cardiac or vascular surgical procedure within the last 6 months, including endarterectomy, bypass or angioplasty; \n\n Ongoing investigation for suspected malignancy; \n\n Confirmed active malignancy; \n\n Concomitant hormone therapy for malignancy; \n\n Concomitant hormone contraceptive pill; \n\n Macroscopic hematuria; \n\n Known or suspected tranexamic acid allergy; \n\n Pregnancy or breastfeeding; \n\n Concomitant use of anticoagulant medication; \n\n Any concern from the attending physician.", - "brief_summary": "BACKGROUND Chronic subdural hematoma (CSDH) is one of the most frequent reasons for cranial neurosurgical consult. There is no widely accepted medical treatment for CSDH.~This trial will investigate whether Tranexamic Acid (TXA) can increase the rate of CSDH resolution following conservative management, lower the number of required surgical procedures and decrease the rate of CSDH recurrence following surgical evacuation. TRACS is a double blind, randomized, parallel-design, placebo-controlled, phase IIB study designed to provide preliminary efficacy data as well as feasibility, safety and incidence data required to plan a larger definitive phase III trial.~METHODS Consecutive patients presenting at the Centre Hospitalier Universitaire de Sherbrooke with a recent (< 14 days) diagnosis of subdural hematoma with a chronic component will be screened for eligibility. Exclusion criteria include specific risk factors for thromboembolic disease, anticoagulant use or contraindication to TXA. A total of 130 patients will be randomized to receive either 750 mg of TXA daily or placebo until complete radiological resolution of the CSDH or for a maximum of 20 weeks. CSDH volume will be measured on serial CT scanning. Cognitive function tests, quality of life questionnaires as well as functional autonomy assessments will be performed at enrollment, 10 weeks follow-up and 3 months post-treatment follow-up. During the treatment period, patients will undergo standard CSDH management with surgery being performed at the discretion of the treating physician. If surgery is performed, the CSDH and its outer membrane will be sampled for in vitro analysis.~The primary outcome is the rate of CSDH resolution at 20 weeks without intervening unplanned surgical procedure. Secondary outcomes include CSDH volume, incidence of surgical evacuation procedures, CSDH recurrence, cognitive functions, functional autonomy, quality of life, incidence of complications and length of hospital stay. Planned subgroup analyses will be performed for conservatively vs surgically-managed subjects and highly vs poorly vascularised CSDH.~DISCUSSION CSDH is a frequent and morbid condition for which an effective medical treatment has yet to be discovered. The TRACS trial will be the first prospective study of TXA for CSDH.", - "NCTID": "NCT02568124" - }, - { - "brief_title": "Hypothermia for Cardiac Arrest in Paediatrics", - "phase": "Phase 2", - "drugs": "['Normothermia', 'Hypothermia']", - "drugs_list": [ - "Normothermia", - "Hypothermia" - ], - "diseases": "['Cardiac Arrest']", - "diseases_list": [ - "Cardiac Arrest" - ], - "enrollment": "38.0", - "inclusion_criteria": "inclusion criteria: \n\n Informed consent by parent or legal guardian \n\n Age \u2265 38 weeks gestation up to and including 17 years \n\n Patient admitted with a diagnosis of a cardiac arrest requiring compressions \u22653 minutes \n\n Remain comatose i.e. have Glasgow Coma Score less than or equal to 10 assessed at the tertiary level pediatric hospital at least 1 hour post- cardiac arrest \n\n Invasive mechanical ventilation \n\n ", - "exclusion_criteria": ": \n\n Cardiac arrest lasting \u226545 minutes, irregardless of commencement of ECMO \n\n Refractory hemorrhagic shock \n\n Dysrhythmia leading to cardiac arrest, where cooling would be part of standard therapy \n\n Suspected diagnosis of brain death as defined as fixed and dilated pupils, Glasgow Coma Score of 3 and no evidence of brain function on neurological examination \n\n Patients who have had a prolonged cardiac arrest at the scene of a trauma \n\n Decision to withhold (DNR) or withdraw life sustaining therapies \n\n Acute Birth asphyxia \n\n Terminal illness, not expected to survive 12 months \n\n Cardiac arrest caused by septic shock \n\n Severe neurodevelopmental disability or persistent vegetative state prior to cardiac arrest \n\n Near drowning in ice water and temperature <32\u00baC on admission to study site \n\n It has been more than 6 hours following cardiac arrest (estimated by first responder) \n\n Previous enrolment in the HypCAP Pilot Study \n\n Pregnant \n\n Parent/Guardian refuse consent \n\n Responsible physician refuses to enrol patient", - "brief_summary": "The investigators hypothesized that, following cardiac arrest in pediatric patients, hypothermia therapy will improve the proportion of patients with a good functional outcome compared to a normothermic control group.", - "NCTID": "NCT00754481" - }, - { - "brief_title": "Impact of Herniation on WFNS Grading in Spontaneous Subarachnoid Hemorrhage - a SWISS SOS Observational Trial", - "phase": "", - "drugs": "['Clinical assessment']", - "drugs_list": [ - "Clinical assessment" - ], - "diseases": "['Subarachnoid Hemorrhage']", - "diseases_list": [ - "Subarachnoid Hemorrhage" - ], - "enrollment": "250.0", - "inclusion_criteria": "inclusion criteria: \n\n Written informed consent of the patient or consent of patient's next of kin \n\n Spontaneous SAH \n\n Age: \u226518 \n\n Glasgow coma scale (GCS) \u2264 12. In intubated patients the GCS assessment will be performed after cessation of sedation or if not possible the last GCS score before intubation will be used \n\n ", - "exclusion_criteria": " \n\n SAH due to any other cause or structural abnormality of the brain (trauma, dissection, arterio-venous malformation, dural arterio-venous fistula) \n\n Foreseeable difficulties in follow-up due to geographic reasons (e.g., patients living abroad)", - "brief_summary": "All patients (\u226518 years) with a spontaneous SAH proven by computed tomography (CT), magnetic resonance imaging (MRI) or lumbar puncture will be considered for this trial. Upon presentation to a neurosurgical centre the patients will be treated according to the local protocol. Upon admission the patient is clinically evaluated for occurrence of clinical signs of brain herniation syndromes (anisocoria, bilateral dilated pupils, posturing). Usually first line treatment includes neurological resuscitation (placement external cerebrospinal fluid drainage in case of hydrocephalus, treatment of seizure, and general intensive care measures). Hereafter, the patient is clinically evaluated for a second time. The patients will be graded according to the usual WFNS scale and the modified herniation WFNS scale. The whole treatment of the patient will be according to local clinical protocols. Outcome will be measured at six and twelve months by trained investigators who are unaware of clinical data. The primary endpoint is the difference of specificities of the WFNS and hWFNS with respect to poor outcome (mRS 4-6) at 6 months after initial haemorrhage. Given that specificity and sensitivity are negatively correlated, difference in sensitivity will be the second primary outcome.~The null hypothesis to be tested is that the ratio of the true negative rates (specificity) of the hWFNS and WFNS scores is 1.35 i.e. the new score will detect 35% more patients as truly negative (good outcome) as compared to the old score. In addition and because of the negative correlation between specificity and sensitivity we will also test that the ratio of the true positive rate (sensitivity) is not below 0.82 i.e. the new score will not more than 18% less patients as truly positive (poor outcome).", - "NCTID": "NCT02304328" - }, - { - "brief_title": "The Effect of Subdural Drain Placement After Burr Hole Evacuation of Chronic Subdural Haematomas on Recurrence: a Prospective Randomised-controlled Multi-centre Study", - "phase": "Phase 3", - "drugs": "['Silicon subdural drain placement after burr hole evacuation of chronic subdural hematoma']", - "drugs_list": [ - "Silicon subdural drain placement after burr hole evacuation of chronic subdural hematoma" - ], - "diseases": "['Chronic Subdural Hematoma', 'Subdural Drain']", - "diseases_list": [ - "Chronic Subdural Hematoma", - "Subdural Drain" - ], - "enrollment": "260.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients diagnosed to have symptomatic chronic subdural haematoma confirmed by a computed tomography or magnetic resonance imaging brain scan. \n\n Ethnic Chinese \n\n Age >/= 60 years-old \n\n Reasonable expectation of completion of outcome measures at follow-up \n\n Written informed consent \n\n ", - "exclusion_criteria": ": \n\n Unsalvageable patients: fixed and dilated pupils after resuscitation or signs of brainstem herniation that precludes definitive therapy. \n\n When the operating surgeon judges that drain placement may be hazardous or to be of limited benefit e.g. readily expanded brain in young patients. \n\n History of previous cranial neurosurgical procedure. \n\n On concurrent glucocorticoid therapy. \n\n Suspected intracranial hypotension syndrome. \n\n Blood dyscrasia: \n\n Use of antiplatelet medication e.g. aspirin or warfarin without adequate reversal or observation for drug effect to wear off (at least 5-7 days). \n\n Thrombocytopenia: platelet level <100 x 109/l \n\n Coagulopathy: prothrombin time PT >12sec or, activated partial thromboplastin time (APTT) >37.4 sec \n\n End-stage renal/ hepatic failure. \n\n Known or strong suspicion of alcohol or illicit drug abuse. \n\n Pregnancy \n\n Known epilepsy \n\n Any neurological or non-neurological condition independent from SAH that might influence the functional outcome or other efficacy outcome measures", - "brief_summary": "This is a prospective randomised-controlled multi-centre trial based in Hong Kong to determine whether temporary subdural drain placement after burr hole evacuation of a chronic subdural haematoma can reduce the risk of recurrence. Consecutive patients, 60 years old or above, diagnosed to have symptomatic chronic subdural haematoma and indicated for burr hole operative drainage will be randomly allocated into one of two groups: (1) for intra-operative subdural drain placement (intervention group) or (2) not for drain placement (control group). Using web-based software block randomisation with an allocation ratio of 1:1 will be conducted. Instructions to use or not to use a drain will be contained in a sealed envelopes labelled with sequential study numbers.~Intra-operatively, if the surgeon-in-charge judges that after burr hole evacuation of the haematoma the patient's condition is unsafe for drain placement, the subject will be excluded from the study. Otherwise, randomisation will be performed at this juncture by the opening of the sealed envelop. The procedure involves placing a prefabricated silicon drain into the subdural space according to a standard protocol and will be removed on the second post-operative day at the bedside. Subjects in whom the operating surgeon judges that drain placement is unsafe will be excluded from the study. Drainage is undertaken passively by hanging the collection bag at the bedside in a dependent position. In addition to general demographic, clinical and radiological presentation data, potential risk factors for recurrence will be documented. Serial computed tomography brain scans will be arranged (before discharge, at four weeks and six months) and the occurence of significant subdural haematoma recurrence requiring repeat operative drainage at six months will be recorded. Other outcome measures to be determined at regular time intervals for a total follow-up period of six months (upon discharge, at four weeks and six months) include: functional performance in terms of the extended Glasgow Outcome Scale and modified Rankin Scale, added neurological deficit, death and other surgery-related complications. All outcomes will be documented by the trial investigators or by the responsible clinician. The data obtained will be analysed according to the principle of intention to treat.~Hypothesis: compared to burr-hole evacuation of chronic subdural haematoma alone (control), the additional placement of a subdural drain after evacuation (intervention) will reduce the risk of recurrence requiring repeat surgery.", - "NCTID": "NCT01785797" - }, - { - "brief_title": "Evaluation of a Non-invasive Brain Compliance Measurement Device", - "phase": "", - "drugs": "['this is not an intervention study', 'this is not an intervention study', 'MRI']", - "drugs_list": [ - "this is not an intervention study", - "this is not an intervention study", - "MRI" - ], - "diseases": "['Diabetes', 'Diabetic Ketoacidosis']", - "diseases_list": [ - "Diabetes", - "Diabetic Ketoacidosis" - ], - "enrollment": "14.0", - "inclusion_criteria": "inclusion criteria: \n\n To be eligible for the study, all subjects must meet the following criteria: \n\n Healthy control OR \n\n Clinical new onset or established diagnosis of diabetes with diabetes ketoacidosis as defined by the Pediatric Endocrine Society Consensus Statement guidelines \n\n Age 10 years to less than 17 years \n\n Parent/guardian understand the study protocol and agrees to comply with it. \n\n Primary care giver (i.e parent/guardian) comprehends written English. This is due to the fact that questionnaires and neurocognitive testing tools used as outcome measures do not have validated versions in Spanish or other language. Subject comprehends and speaks English. \n\n ", - "exclusion_criteria": ": \n\n Subjects who meet any of the following criteria are not eligible for the study: \n\n History of head trauma with any loss of consciousness \n\n History of premature birth (less than 30 weeks of gestation) \n\n History of significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age \n\n History of neurologic disease independent of diabetes (seizure disorder)", - "brief_summary": "This is a research study to understand how diabetic ketoacidosis may affect the brain and learning and to see if these changes are transient or permanent. The investigators hope to learn more about how diabetic ketoacidosis may cause changes in brain compliance (by wearing a non-invasive head band/helmet like device from Jan Medical: The Nautilus Neurowave System\u2122 (NNS), learning, talking, behavior, or development. The investigators will compare those results from those with diabetes mellitus to those age and gendered matched healthy controls. Possible subjects in this study have diabetes mellitus and are between the ages of 10 to less than 17 years old OR do NOT have diabetes and are between the ages of 10 to less than 17 years old.", - "NCTID": "NCT01753921" - }, - { - "brief_title": "Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study", - "phase": "Phase 4", - "drugs": "['Glycerna', 'Jevity - Control Diet']", - "drugs_list": [ - "Glycerna", - "Jevity - Control Diet" - ], - "diseases": "['Subarachnoid Hemorrhage', 'Intracranial Hemorrhage', 'Ischemic Strokes', 'Subdural Hematoma']", - "diseases_list": [ - "Subarachnoid Hemorrhage", - "Intracranial Hemorrhage", - "Ischemic Strokes", - "Subdural Hematoma" - ], - "enrollment": "14.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients aged between 18 and 89 years old \n\n Patients with critical illness including ischemic or hemorrhagic stroke, epidural/subdural bleeds and subarachnoid hemorrhage \n\n Patients who are expected to stay in the ICU for at least 5 days \n\n Hyperglycemia is not an inclusion criteria \n\n ", - "exclusion_criteria": ": \n\n Patients who have received or will be treated with systemic corticosteroids. \n\n Patients who will be receiving high doses of propofol (>40 cc/hr) \n\n Patients with type 1 Diabetes \n\n Patients with sepsis or acute trauma \n\n Patients with an expected stay in the ICU of less than 4 days \n\n Patients who are unable to receive enteral nutrition or who have medical conditions precluding nutrition by the enteral route including allergies to formula components \n\n Pregnant and lactating patients \n\n Patients with prior history of gastroparesis \n\n Patients with acute kidney failure (creatinine > 2.5mg/dl) \n\n Patients with acute liver failure (bilirubin > 2.0 mg/dl)", - "brief_summary": "Primary Objective:~To determine the effects of a diabetes specific enteral formula compared to a standard formula supplemented with protein (isocaloric and isonitrogenous) on the mean blood glucose and glycemic variability in a homogenous group of critically ill patients in a neurological ICU. Blood glucose will be recorded every minute using a continuous blood glucose monitor. The primary end points will be the difference between the mean blood glucose levels and the glucose variability between the control and intervention groups for the time period that the patient is in the ICU and receiving tube feeds and for up to a maximum of 14 days.~Secondary Objectives:~To determine the effects of the diabetes specific versus standard tube feeds on the change in muscle thickness and volume measured by 2-dimensional ultrasound imaging during the patients ICU stay.", - "NCTID": "NCT01463878" - }, - { - "brief_title": "A Prospective Randomized Study Evaluating the Recurrence Rate of Chronic Subdural Hematoma After Placing a Subperiosteal Drainage Compared to a Subdural Drainage", - "phase": "", - "drugs": "['Subdural Drainage', 'Subperiosteal Drainage']", - "drugs_list": [ - "Subdural Drainage", - "Subperiosteal Drainage" - ], - "diseases": "['Chronic Subdural Hematoma']", - "diseases_list": [ - "Chronic Subdural Hematoma" - ], - "enrollment": "220.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient at least 18 years of age presenting with a symptomatic chronic subdural hematoma \n\n Chronic subdural hematoma verified on cranial CT or MRI \n\n ", - "exclusion_criteria": ": \n\n The surgeon decides based on intraoperative conditions to perform a craniotomy (e.g. acute hematoma indicating a craniotomy) \n\n Chronic subdural hematoma caused by another underlying illness (e.g. caused by over-drainage of a vp-shunt) \n\n no informed consent", - "brief_summary": "The aim of our study is to investigate in randomized controlled fashion whether the recurrence and complication rate, after insertion of subperiosteal drainage in the treatment of chronic subdural haematoma, is higher compared to insertion of subdural drainage.~We hypothesize that patients treated with a subperiosteal drainage do not show higher recurrence rates than those treated with a subdural drainage, and suffer less complications.", - "NCTID": "NCT01869855" - }, - { - "brief_title": "Effect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma", - "phase": "Phase 2", - "drugs": "['Atorvastatin', 'placebo']", - "drugs_list": [ - "Atorvastatin", - "placebo" - ], - "diseases": "['Chronic Subdural Hematoma']", - "diseases_list": [ - "Chronic Subdural Hematoma" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 18 and <90 years old, male or female; \n\n CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult); \n\n Markwalder's Grading Scale and Glasgow Coma Scale (MGS-GCS) 20 mm Hg) who requires ICP monitoring and osmotherapy \n\n Major confounding factors for withdrawal syndrome by causing shivering, sympathetic drive and autonomic disorders \n\n Underlying active neurological condition (status epilepticus, encephalopathy, hypoxia) \n\n Neurological problems are covariates, which would make the assessment of sedation or IWS difficult Patient previously included in the study at any of the two hospitals (readmission to the ICU at a later date during the period of recruitment for the study, limiting to 1 weaning episode per patient) \n\n Thoracic and cervical spinal cord injury \n\n Adrenergic response to pain will be difficult to assess \n\n Unable to assess validated tool: DSM-V, RASS, CAM-ICU \n\n Narcotic \n\n If the underlying neurological condition resolves within the 96 hours, the patient may be included in the study \n\n Substance abuse prior to ICU admission (28) \n\n Chronic alcohol use defined as alcohol consumption of more than 2 drinks per day and/or more than 14 drinks per week for men and 9 drinks per week for woman as reported by family or as per patient's medical record", - "brief_summary": "Critically ill patients who are mechanically ventilated may require prolonged administration of sedatives and analgesics. Their prolonged use has been associated with withdrawal symptoms upon rapid weaning in critically ill patients. These withdrawal symptoms may be associated with adverse clinical outcomes. Although well studied in the paediatric population, little is known about the epidemiology, risk factors and optimal screening methods in adults. Studying this problem is essential as we strive to develop proper weaning strategies.~Methods: Prospective observational two-center study in critically ill adult patients Objectives: 1) Describe the incidence of iatrogenic withdrawal of sedatives and analgesics in critically ill adult patients and 2) Evaluate the performance of screening tools assessing withdrawal that were developed for the paediatric patient in the adult population.", - "NCTID": "NCT02318290" - }, - { - "brief_title": "Role of Dexamethasone in the Conservative Treatment of Chronic Subdural Hematoma", - "phase": "Phase 4", - "drugs": "['Dexamethasone', 'Placebo']", - "drugs_list": [ - "Dexamethasone", - "Placebo" - ], - "diseases": "['Hematoma, Subdural, Chronic']", - "diseases_list": [ - "Hematoma", - "Subdural", - "Chronic" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years and older \n\n evidence of subacute or chronic supratentorial subdural hematoma by CT (computerized tomography) scan or MRI (magnetic resonance imaging) \n\n classified between 0 and 2 using the Markwalder grading scale \n\n ", - "exclusion_criteria": ": \n\n contraindications or intolerance to corticosteroid therapy \n\n patients already undergoing steroid treatment for any other indication \n\n previous neurological surgery up to one year prior to being considered for the study \n\n concomitant cerebral pathology of neoplastic or presumed infectious origin \n\n anticoagulant therapy that could not be stopped for 6 months \n\n refusal to participate in the study", - "brief_summary": "Current opinion regarding the use of steroids in the treatment of chronic subdural hematomas are mostly based on observational studies. Here we present data from a prospective randomized pilot study of twenty chronic subdural hematoma (CSDH) patients treated with dexamethasone or placebo for 30 days.~Twenty patients with computed tomography (CT)- or magnetic resonance imaging (MRI)-confirmed CSDH were recruited from a single center and randomized in order to receive dexamethasone or placebo as a conservative treatment. Patients affected to the treatment group received oral dexamethasone 12mg/day for three weeks followed by tapering. These patients were followed for 6 months and the rate of success of conservative treatment versus placebo was measured. Parameters such as hematoma thickness and global impression of change were also compared before and after treatment with chi-square tests. Adverse events and complications were documented.", - "NCTID": "NCT02362321" - }, - { - "brief_title": "Detecting Chronic Subdural Hematoma With Microwave Technology", - "phase": "", - "drugs": "['Medfield Strokefinder MD100']", - "drugs_list": [ - "Medfield Strokefinder MD100" - ], - "diseases": "['Chronic Subdural Hematoma', 'Healthy Volunteers']", - "diseases_list": [ - "Chronic Subdural Hematoma", - "Healthy Volunteers" - ], - "enrollment": "41.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient admitted for surgery of chronic subdural hematoma. \n\n A CT scan of the patient has been performed, within the latest 96 hours. \n\n The patient should be able to have a normal conversation and understand the information about the study, corresponding to Glasgow Coma Scale (Verbal Response) of 5. \n\n Patient/healthy volunteer should be \u2265 18 years of age. \n\n The patient/healthy volunteer has signed a written informed consent. \n\n ", - "exclusion_criteria": ": \n\n Females who are pregnant or breast feeding women. \n\n Patient/healthy volunteer has a shunt or other foreign object implanted in the brain. \n\n Patient/healthy volunteer participating in any other clinical study that could interfere with the result in the ongoing study.", - "brief_summary": "An open study evaluating the sensitivity and specificity of a microwave-based device, Medfield Strokefinder MD100, to detect chronic subdural hematoma, by comparing measurements on patients recruited for surgery of chronic subdural hematoma to an age- and gender-matched group of healthy volunteers.", - "NCTID": "NCT02282228" - }, - { - "brief_title": "Surgical Indirect Revascularization For Symptomatic Intracranial Arterial Stenosis", - "phase": "", - "drugs": "['Encephaloduroarteriosynangiosis (EDAS)']", - "drugs_list": [ - "Encephaloduroarteriosynangiosis (EDAS)" - ], - "diseases": "['Intracranial Arterial Stenosis', 'Intracranial Atherosclerosis', 'Ischemic Stroke', 'Cerebral Angiogenesis']", - "diseases_list": [ - "Intracranial Arterial Stenosis", - "Intracranial Atherosclerosis", - "Ischemic Stroke", - "Cerebral Angiogenesis" - ], - "enrollment": "52.0", - "inclusion_criteria": "inclusion criteria: \n\n TIA or non-severe stroke within 30 days of enrollment attributed to 70% to 99% stenosis* of a major intracranial artery (carotid artery or MCA) \n\n *May be diagnosed by TCD, MRA, or CTA to qualify, but must be confirmed by catheter angiography as per usual clinical practice. \n\n Modified Rankin scale score of \u22643 \n\n Target area of stenosis in an intracranial artery that has a normal diameter of 2.00 mm to 4.50 mm \n\n Target area of stenosis is \u226414 mm in length \n\n Age \u226530 years and \u226480 years \n\n * Patients 30 to 49 years of age are required to meet at least 1 additional criteria (i-vi) provided below to qualify for the study. This additional requirement is to increase the likelihood that the symptomatic intracranial stenosis in patients 30 to 49 years is atherosclerotic: i. Insulin-dependent diabetes for at least 15 years ii. At least 2 of the following atherosclerotic risk factors: hypertension (BP \u2265 140/90 mm Hg or on antihypertensive therapy); dyslipidemia (LDL \u2265130 mg/dL or HDL \u226440 mg/dL or fasting triglycerides \u2265150 mg/dL or on lipid lowering therapy); smoking; non-insulin-dependent diabetes or insulin-dependent diabetes of <15 years duration; family history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, and peripheral vascular surgery in parent or sibling who was < 55 years of age for men or < 65 for women at the time of the event. \n\n iii. History of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease iv. Any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery that was documented by noninvasive vascular imaging or catheter angiography and is considered atherosclerotic v. Aortic arch atheroma documented by noninvasive vascular imaging or catheter angiography vi. Any aortic aneurysm documented by noninvasive vascular imaging or catheter angiography that is considered atherosclerotic \n\n Negative pregnancy test in a female who has had any menses in the last 18 months \n\n Patient is willing and able to return for all follow-up visits required by the protocol. \n\n Patient is available by phone. \n\n Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent. \n\n Demonstration of poor or no collateral flow in the territory of the qualifying stenotic vessel (ASITN/SIR Collateral Flow Grades 0-2) and hypoperfusion of the vascular territory in MRI. \n\n ", - "exclusion_criteria": ": \n\n Tandem extracranial or intracranial stenosis (70-99%) or occlusion that is proximal or distal to the target intracranial lesion \n\n Bilateral intracranial vertebral artery stenosis of 70% to 99% and uncertainty about which artery is symptomatic (e.g., if patient has pontine, midbrain, or temporal occipital symptoms) \n\n Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days before the expected enrollment date \n\n Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform staged angioplasty followed by stenting of target lesion \n\n Plan to perform concomitant angioplasty or stenting of an extracranial vessel tandem to an intracranial stenosis \n\n Presence of intraluminal thrombus proximal to or at the target lesion \n\n Any aneurysm proximal to or distal to the stenotic intracranial artery \n\n Intracranial tumor (including meningioma) or any intracranial vascular malformation \n\n Computed tomographic or angiographic evidence of severe calcification at target lesion \n\n Thrombolytic therapy within 24 hours before enrollment \n\n Progressive neurologic signs within 24 hours before enrollment \n\n Brain infarct within previous 30 days of enrollment that is of sufficient size (> 5 cm) to be at risk of hemorrhagic conversion during or after surgery \n\n Any hemorrhagic infarct within 14 days before enrollment \n\n Any hemorrhagic infarct within 15 to 30 days that is associated with mass effect \n\n Any history of a primary intracerebral (parenchymal) hemorrhage \n\n Any other intracranial hemorrhage (subarachnoid, subdural, or epidural) within 30 days \n\n Any untreated chronic subdural hematoma >5 mm in thickness \n\n Intracranial arterial stenosis related to arterial dissection, Moya-Moya disease; any known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebrospinal fluid pleocytosis; radiation-induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process, and suspected recanalized embolus \n\n Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction <30% \n\n Known allergy or contraindication to aspirin and local or general anesthesia \n\n History of life-threatening allergy to contrast dye. If not life-threatening and can be effectively pretreated, patient can be enrolled at physician's discretion \n\n Known absolute contraindication to obtaining MRI studies, such as magnetically activated implanted devices (cardiac pacemakers, insulin pumps, neuro-stimulators, and cochlear implants), MRI incompatible orthopedic implants, and free metallic fragments in the brain or eye. \n\n Active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets <100,000, hematocrit <30, INR >1.5, clotting factor abnormality that increases the risk of bleeding, current alcohol or substance abuse, uncontrolled severe hypertension (systolic BP>180 mm Hg or diastolic BP>115 mm Hg), severe liver impairment (AST or ALT > 3 times normal, cirrhosis), creatinine > 3.0 (unless on dialysis) \n\n Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 90 days after enrollment \n\n Indication for warfarin or heparin beyond enrollment (NOTE: Exceptions allowed for use of subcutaneous heparin for deep venous thrombosis prophylaxis while hospitalized) \n\n Severe neurologic deficit that renders the patient incapable of living independently \n\n Dementia or psychiatric problem that prevents the patient from following an outpatient program reliably \n\n Comorbid conditions that may limit survival to < 3 years \n\n Females who are pregnant or of childbearing potential and unwilling to use contraception for the duration of this study \n\n Enrollment in another study that would conflict with the current study \n\n Surgical Specific ", - "brief_summary": "Stroke due to intracranial arterial atherosclerosis is a significant medical problem, carrying one of the highest rates of recurrent stroke despite best medical therapy, with annual recurrence rates as elevated as 25% in high risk groups.~The goal of this investigation is to advance a promising surgical treatment for symptomatic atherosclerotic intracranial stenosis - encephaloduroarteriosynangiosis (EDAS). The investigation will test in a phase II futility trial the potential of EDAS for further development before proceeding with the design of a definitive clinical trial of EDAS Revascularization in patients with Symptomatic Intracranial Arterial Stenosis (ERSIAS).~The investigation is a 4-year futility trial to test the hypothesis that EDAS revascularization combined with aggressive medical therapy warrants further evaluation in a subsequent pivotal trial as an alternative to aggressive medical management alone for preventing the primary endpoint of stroke or death in patients with symptomatic intracranial arterial stenosis (Specific Aim 1). During the investigation the time course of collateralogenesis and perfusion improvement following EDAS will also be evaluated (Specific Aim 2.", - "NCTID": "NCT01819597" - }, - { - "brief_title": "Analgesic Efficacy of Morphine Alone or Combined With Paracetamol and/or Ibuprofen for Long-bones Fractures in Children", - "phase": "Phase 3", - "drugs": "['Paracetamol', 'Ibuprofen', 'paracetamol + ibuprofen', 'Placebo']", - "drugs_list": [ - "Paracetamol", - "Ibuprofen", - "paracetamol + ibuprofen", - "Placebo" - ], - "diseases": "['Pain', 'Long-bone Fractures']", - "diseases_list": [ - "Pain", - "Long-bone Fractures" - ], - "enrollment": "304.0", - "inclusion_criteria": "inclusion criteria: \n\n children aged 2 through 17 years (17 years included) \n\n suspected fracture of a long bone requiring morphine analgesia (VAS \u2265 60/100 or Evendol \u2265 7/15 at the arrival at emergency department) \n\n within the first 12 hours after the injury \n\n at least one signed parental informed consent \n\n affiliated to health insurance \n\n ", - "exclusion_criteria": ": \n\n analgesic treatment within the 6 hours before inclusion \n\n contraindication to one of the experimental drug: Paracetamol or Ibuprofen \n\n contraindication to Morphine \n\n cognitive impairment \n\n multiple injuries \n\n resuscitation man\u0153uvres \n\n suspected femur fracture \n\n open fracture \n\n pregnant women in the third trimester", - "brief_summary": "The main objective of this study is to evaluate the efficacy of two drugs: paracetamol and ibuprofen in association with morphine, compared with morphine alone on analgesia in children seen in the emergency department for a long-bone fracture and also to study the potential synergic effect of the association paracetamol and ibuprofen.", - "NCTID": "NCT02477007" - }, - { - "brief_title": "The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders", - "phase": "Phase 2", - "drugs": "['Atorvastatin', 'Atorvastatin and Dexamethasone']", - "drugs_list": [ - "Atorvastatin", - "Atorvastatin and Dexamethasone" - ], - "diseases": "['Chronic Subdural Hematoma']", - "diseases_list": [ - "Chronic Subdural Hematoma" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u226518 and<90years old, both gender; \n\n Long-term antiplatelet and anticoagulant drugs cause Coagulation Disorders; \n\n CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult); \n\n The midline shift to less than 1 cm; \n\n Attending physician makes a judgment that cerebral hernia would not occur and surgical operation might not be performed in a short time. Conservative treatment is adopted; \n\n Patients have never undergo surgery on the hematoma; \n\n Patient fully understood the nature of the study, and voluntarily participates and signs informed consent. \n\n ", - "exclusion_criteria": ": \n\n Allergic to the statin and dexamethasone or its ingredients; \n\n Hematoma caused by tumors, blood and other known comorbidities; \n\n Abnormal liver function; \n\n Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study; \n\n Patients have been on oral Statin treatment in the past four weeks; \n\n Patients have been on oral Steroids treatment for a long time; \n\n Diagnosed Diabetes patients with poorly controlled blood glucose \n\n Participate in clinical trials in the past four weeks; \n\n Pregnant or breastfeeding; \n\n Failure of completing the trial by poor compliance; \n\n For any reason, the researchers believe that the case is not suitable for inclusion.", - "brief_summary": "To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders", - "NCTID": "NCT02192320" - }, - { - "brief_title": "Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors", - "phase": "", - "drugs": "['Perindopril', 'Placebo']", - "drugs_list": [ - "Perindopril", - "Placebo" - ], - "diseases": "['Hematoma, Subdural, Chronic']", - "diseases_list": [ - "Hematoma", - "Subdural", - "Chronic" - ], - "enrollment": "47.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with chronic subdural hematoma that needs surgical evacuation \n\n Age > 18 year \n\n ", - "exclusion_criteria": ": \n\n Lack of compliance \n\n Kidney artery stenosis \n\n Stenosis of the aorta \n\n Severely decreased kidney function \n\n Allergy or intolerance/contraindications toward ACE inhibitors \n\n Already in ACE inhibitor treatment \n\n Coagulopathies \n\n Malignant disorders \n\n Fertile women \n\n Other neurological disorders \n\n Treatment with pharmaceuticals contraindicating treatment with ACE inhibitors", - "brief_summary": "The project aims at investigating if treatment with the Angiotensin Converting Enzyme inhibitor Coversyl (perindopril) for 3 months after surgery for chronic subdural hematoma will decrease the risc of recurrence.", - "NCTID": "NCT00915928" - }, - { - "brief_title": "Effect of Remifentanil on the Recovery Profile After Prolonged Head and Neck Surgery", - "phase": "", - "drugs": "['Remifentanil', 'choice of intra-operative opioids were left to the discretion of anesthesiologist']", - "drugs_list": [ - "Remifentanil", - "choice of intra-operative opioids were left to the discretion of anesthesiologist" - ], - "diseases": "['Pain', 'Head and Neck Disorder']", - "diseases_list": [ - "Pain", - "Head and Neck Disorder" - ], - "enrollment": "222.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with ASA I to II, scheduled for elective head and neck surgery with minimum expected duration of 2 hours, requiring general anesthesia \n\n ", - "exclusion_criteria": ": \n\n previous history of either drug or alcohol abuse those who have been using opioids for long term mental disorder with difficult to understand pain scoring system ASA physical status of III and above surgical procedure warranting elective postoperative ventilation", - "brief_summary": "Opioid tolerance in the perioperative period is inevitable especially with ultra-short acting agents such as remifentanil. Existing evidence had shown that opioid induced hyperalgesia due to neuroplastic changes in the central as well as peripheral nervous system leads to sensitization of pro-nociceptive pathways. However there has been a controversy of occurrence of such tolerance following the use of remifentanil and the quality of recovery as compared to conventional opioids. The investigators evaluated the occurrence of opioid tolerance and other significant adverse effects with remifentanil in subjects undergoing head and neck surgeries. The investigators studied ASA physical status I and II adult subjects undergoing elective head and neck procedures, under general anesthesia with minimum expected duration of 2 hours. The remifentanil infusion was used in one group and intermittent boluses of morphine or fentanyl administered in another group. They were evaluated for immediate post-operative pain by using numerical rating scale (NRS), the opioid consumption, post-operative nausea, vomiting, other significant adverse effects of remifentanil and the time to discharge from PACU.", - "NCTID": "NCT02416752" - }, - { - "brief_title": "The Affect of a Ventilated Helmet on Physiological Load", - "phase": "", - "drugs": "['Ventilated Helmet']", - "drugs_list": [ - "Ventilated Helmet" - ], - "diseases": "['Physiological Strain']", - "diseases_list": [ - "Physiological Strain" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria: \n\n healthy civilian volunteers \n\n aged 21-28 \n\n without known medical illnesses or medication use \n\n ", - "exclusion_criteria": ": \n\n the existence of or suspicion of existing cardiac or respiratory disease \n\n hypertension \n\n diabetes \n\n any hormonal disease or any other chronic illness that may inhibit participation in the experiment \n\n infectious disease 3 days prior to the experiment.", - "brief_summary": "The use of infantry helmets under heavy heat stress conditions, during physical exertion, may hinder the body's ability to effectively dissipate heat from the head area, thereby damaging the soldier's function. Therefore head cooling may potentially enable a longer duration of activity until reaching fatigue. An improvement in function may also be possible.The purpose of this research is to determine the extent of the cognitive and physiological strain caused by wearing a helmet under exertional conditions while exposed to heavy heat stress and to evaluate the effect of a unique ventilation system connected to the helmet on strain reduction.", - "NCTID": "NCT01595906" - }, - { - "brief_title": "Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study", - "phase": "", - "drugs": "['Video Nailfold Capillaroscopy', 'Ambulatory 24 hr Blood Pressure Monitoring', 'Fundoscopy of eyes', 'Laser Doppler Flowmetry']", - "drugs_list": [ - "Video Nailfold Capillaroscopy", - "Ambulatory 24 hr Blood Pressure Monitoring", - "Fundoscopy of eyes", - "Laser Doppler Flowmetry" - ], - "diseases": "['Type 1 Diabetes Mellitus']", - "diseases_list": [ - "Type 1 Diabetes Mellitus" - ], - "enrollment": "26.0", - "inclusion_criteria": "inclusion criteria: \n\n 8-18 years old \n\n Have a diagnosis of type 1 diabetes mellitus \n\n ", - "exclusion_criteria": ": \n\n < 8 years or > 18 years old \n\n Significant autoimmune rheumatological disease (e.g. lupus or dermatomyositis)", - "brief_summary": "This project aimed to explore novel methods of detecting small blood vessel disease in a paediatric population with type 1 diabetes mellitus. To do this the techniques of Nailfold capillaroscopy, laser Doppler flowmetry, retinal (eye) vessel analysis and 24-hr Ambulatory Blood Pressure Monitoring were used. Each of these techniques investigated different areas of small blood vessels around the body.~It was hypothesized that in a paediatric population with type 1 diabetes mellitus the novel investigations would be associated with small blood vessel disease and that widespread changes to these blood vessels would be detected through associations between the different novel investigations.", - "NCTID": "NCT01279928" - } - ], - "1": [ - { - "brief_title": "Cases With Traumatic and Non Traumatic Brain Damage Treated in the Intensive Care", - "phase": "", - "drugs": "['type of the brain injury', 'type of the brain injury', 'type of the brain injury', 'type of the brain injury', 'type of the brain injury', 'type of the brain injury']", - "drugs_list": [ - "type of the brain injury", - "type of the brain injury", - "type of the brain injury", - "type of the brain injury", - "type of the brain injury", - "type of the brain injury" - ], - "diseases": "['Brain Injuries']", - "diseases_list": [ - "Brain Injuries" - ], - "enrollment": "135.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients treated in the ICU with the diagnose of traumatic or nontraumatic brain damage, with a more than 24-hour stay. \n\n ", - "exclusion_criteria": ": \n\n Patients admitted less than 24 hour.", - "brief_summary": "Cases of traumatic and nontraumatic brain damage have high rates of morbidity and mortality. In this study of cases being treated in the ICU for a diagnosis of brain damage, it was aimed to evaluate the relationship between mortality and the distribution of reason for and resulting type of brain damage and to determine other factors affecting mortality.", - "NCTID": "NCT02475226" - } - ], - "2": [ - { - "brief_title": "Hypothermia in Traumatic Brain Injury in Children (HiTBIC)", - "phase": "Phase 2; Phase 3", - "drugs": "['Induced Hypothermia']", - "drugs_list": [ - "Induced Hypothermia" - ], - "diseases": "['Traumatic Brain Injury']", - "diseases_list": [ - "Traumatic Brain Injury" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n have a severe traumatic brain injury as defined by either a GCS \u2264 8 and an abnormal CT scan (intracranial hemorrhage, cerebral edema or diffuse axonal injury) or a motor score \u2264 3 and normal CT scan \n\n are aged between 1 and 16 years \n\n are mechanically ventilated \n\n ", - "exclusion_criteria": ": \n\n are not randomized by 6 hours after injury \n\n have penetrating brain injuries \n\n have fixed dilated pupils and GCS = 3 \n\n have proven cervical spinal cord injury \n\n have more than mild neurodevelopmental disability prior to injury \n\n have an acute isolated epidural hematoma and are expected to recover rapidly after surgical removal \n\n have had a post-traumatic seizure with a normal CT scan \n\n have refractory shock, defined as systolic blood pressure more than 2 standard deviations (SD) below the mean for age despite 80ml/kg intravenous fluid resuscitation", - "brief_summary": "The purpose of this study is:~To determine the safety and feasibility of performing an international multi-centre randomized control trial of early and prolonged hypothermia to improve outcome in children with severe traumatic brain injury (TBI).~To determine whether in children with severe traumatic brain injury, prolonged initial hypothermia (minimum 72 hours at 32-33 degrees) improves the proportion of good outcomes 12 months after injury when compared to initial normothermia (36-37 degrees).", - "NCTID": "NCT00282269" - }, - { - "brief_title": "Hypothermia in Children After Trauma", - "phase": "Phase 3", - "drugs": "['induced moderate hypothermia']", - "drugs_list": [ - "induced moderate hypothermia" - ], - "diseases": "['Traumatic Brain Injury']", - "diseases_list": [ - "Traumatic Brain Injury" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with a GCS 16/40 sec, INR > 1.7) \n\n Hypotensive episode (Systolic Blood Pressure <5th percentile for age>10 min) \n\n Documented Hypoxic episode (O2 saturation < 94% for > 30 min) \n\n Pregnancy", - "brief_summary": "The primary hypothesis for this application for a multicenter phase III randomized clinical trial (RCT) is that induced moderate hypothermia (HYPO) (32-33 \u00b0C) after severe traumatic brain injury (TBI) in children and maintained for 48 hours will improve mortality at 3 months and 12 month functional outcome as assessed by the Glasgow Outcome Scale (GOS).", - "NCTID": "NCT00222742" - }, - { - "brief_title": "Pediatric Traumatic Brain Injury: Methylphenidate Effects on Early Recovery", - "phase": "Phase 4", - "drugs": "['methylphenidate']", - "drugs_list": [ - "methylphenidate" - ], - "diseases": "['Brain Injuries']", - "diseases_list": [ - "Brain Injuries" - ], - "enrollment": "", - "inclusion_criteria": "Moderate to severe traumatic brain injury", - "exclusion_criteria": "", - "brief_summary": "Traumatic Brain Injury (TBI) is the leading cause of acquired long term disability among children and young adults. Deficits in attention and memory are common and persist for years after moderate or severe TBI. The similarity between these symptoms and those of children with AD/HD, the efficacy of methylphenidate in the treatment of AD/HD, and the efficacy of methylphenidate in improving recovery of animals with brain injuries, support the need to study methylphenidate effects in children with TBI. This investigation of methylphenidate in children with moderate to severe TBI aims to: (1) Assess the acute effects of 2 different dosages of methylphenidate on attention and reaction time when the medication is administered to children early in recovery; (2) Assess the ability of 8 weeks of methylphenidate to improve the rate of recovery of cognitive, memory, and attentional skills in children with TBI; (3) Identify the frequency of common methylphenidate side effects in children with TBI.", - "NCTID": "NCT00035139" - }, - { - "brief_title": "Interacting Together Everyday: Recovery After Childhood Traumatic Brain Injury (TBI) I-InTERACT", - "phase": "", - "drugs": "['Internet-based Interacting Together Everyday: Recovery After Childhood TBI', 'Internet Resources Comparison']", - "drugs_list": [ - "Internet-based Interacting Together Everyday: Recovery After Childhood TBI", - "Internet Resources Comparison" - ], - "diseases": "['Traumatic Brain Injury']", - "diseases_list": [ - "Traumatic Brain Injury" - ], - "enrollment": "41.0", - "inclusion_criteria": "inclusion criteria: \n\n Moderate to severe TBI that occurred within the last 24 months \n\n Overnight hospital stay \n\n English-speaking \n\n Parent must be willing to provide informed consent \n\n ", - "exclusion_criteria": ": \n\n Child does not live with parents or guardian \n\n Child or parent has history of hospitalization for psychiatric problem \n\n Diagnosed with moderate or severe mental retardation, autism, or a significant developmental disability", - "brief_summary": "The purpose of this study is to test an on-line intervention for families of young children who have experienced moderate or severe traumatic brain injury (TBI). Previous interventions were not designed to address the needs of young children with TBI, and feedback revealed a desire for more examples and materials appropriate for families of younger children. This project builds upon the investigators previous research by modifying the online intervention content to address the needs of young children with TBI. The goal of this project is to develop an intervention that will encourage positive parenting behaviors, improve child behaviors, and reduce parent distress and burden following TBI. The investigators hypothesize that the intervention group will exhibit more effective parenting skills as well as better child functioning and lower levels of parental distress at follow-up than will the active comparison group.", - "NCTID": "NCT01056146" - }, - { - "brief_title": "Trial Of Normal Saline Versus Ringer's Lactate In Paediatric Trauma Patients", - "phase": "Phase 4", - "drugs": "['Normal Saline', \"Ringer's Lactate\"]", - "drugs_list": [ - "Normal Saline", - "Ringer's Lactate" - ], - "diseases": "['Trauma']", - "diseases_list": [ - "Trauma" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Pediatric trauma patients with Injury Severity Score greater than 12 \n\n Age 1-17 years \n\n Trauma within 8 hours \n\n ", - "exclusion_criteria": ": \n\n Injury Severity Score less than 12 \n\n Pre-existing renal disease \n\n On medication that affects serum sodium (i.e diuretic therapy) \n\n Blood transfusion within first 24 hours \n\n Operation within first 24 hours \n\n Oral intake of fluid or solids in first 24 hours", - "brief_summary": "Background: Trauma is a major cause of death in children and teenagers. When young patients have suffered major traumatic injuries, they require intravenous (iv) fluids to keep their blood vessels full and ensure blood flow to vital organs. Current fluid guidelines by International Trauma Committees recommend either Normal Saline (NS) or Ringer's Lactate (RL) as the fluid of choice for these patients. Although these solutions share some similarities in their composition, there are also some significant differences in sodium, chloride and lactate concentrations. Despite these differences in fluid composition, there has never been a study comparing these two fluids in paediatric trauma patients to determine which is optimal. In this study, the investigators aim to determine the optimal fluid choice for trauma resuscitation of young patients.~Hypothesis: The investigators hypothesize that severely injured paediatric trauma patients resuscitated with NS will have optimal blood sodium levels compared to patients resuscitated with RL.~Methods: The investigators will study 50 paediatric trauma patients that will be randomized so that half will randomly receive NS and half will receive RL as their only iv fluid for 24 hours. After 24 hours, the investigators will compare in blood the sodium level, the amount of acid, and the concentrations of inflammation molecules in relation to those whom received NS versus RL.~Expected Results and Significance: Maintaining optimal levels of these biochemical markers is imperative in reducing morbidity and mortality in severely injured paediatric patients. If significant differences are present, the investigators will be able to determine which fluid is preferred and expect these data to complement current trauma resuscitation guidelines.", - "NCTID": "NCT01692769" - }, - { - "brief_title": "Handlebar Grip Related Injury Prevention (GRIP) Study: Are Exposed Metal Handlebar Ends a Risk Factor for Injury?", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Injuries', 'Trauma', 'Wounds and Injuries', 'Children', 'Child']", - "diseases_list": [ - "Injuries", - "Trauma", - "Wounds and Injuries", - "Children", - "Child" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Children 0-15 years inclusive \n\n Presenting to either of the study hospitals for assessment or treatment \n\n Sustained an injury or suspected to have sustained an injury (i.e. AIS >=0) \n\n Due to an incident involving any non-motorized bicycle, tricycle or kick scooter \n\n ", - "exclusion_criteria": ": \n\n Incidents where the injured child was involved in a motor vehicle collision \n\n Incidents where the injured child was injured by another rider (e.g. injured child run over by a cyclist) \n\n Incidents involving a bicycle fitted with 'bull bars' \n\n Patients for whom neither parent / guardian is fluent in English (if the history is clear from a parent, the patient will be eligible for inclusion) \n\n If an eligible patient is dead on arrival the family will not be invited to participate, and they will not subsequently be contacted \n\n If an eligible patient dies during their admission, they will be withdrawn from further involvement in the study and the family will not be contacted", - "brief_summary": "Cycling injuries are the 3rd most common mechanism of injury in 7-13 year olds[1]. Bicycle injuries have remained one of the commonest causes of paediatric abdominal trauma for over 60 years[2,3]. 15% of child cyclist injuries involve impact with a handlebar; two-thirds of those are abdominal injuries[4]. Handlebar impact is now the commonest mechanism of major paediatric abdominal injury[3]. Serious handlebar injuries often occur after apparently minor falls; they are not unique to riders performing stunts[5].~One small study found that the metal handlebar ends were often exposed on bikes of children sustaining severe abdominal injuries[6]. Most European safety standards do not test grip durability[7-10]. Day-to-day use can damage rubber grips, exposing the underlying metal handlebar tube.~This feasibility study aims to test the research methods that will be used in a subsequent nationwide multicentre study. The main study will investigate the association between injuries and handlebar grip condition.~Children attending study hospitals with any bicycle or kick scooter injury will be invited to participate. Parents of injured children will be invited to complete questionnaires regarding circumstances surrounding the injury and condition of the handlebar ends on the bike or scooter involved. Clinical information regarding the injury will also be collected. The handlebar end condition will be compared between children sustaining a handlebar end injury [Cases] and riders whose injury did not involve the handlebar [Controls].~If exposed handlebar ends are more prevalent amongst riders with handlebar end injuries, injury prevention strategies can focus on methods to prevent damage occurring to grips through day-to-day use. If no such association is found, prevention strategies can be focused elsewhere, such as on design of effective protective clothing.~Data collection for this feasibility study will occur between March 2015 and September 2015.~The Chief Investigator, Mr. Andrew Neilson, funds the feasibility study.", - "NCTID": "NCT02378311" - } - ] - }, - { - "patient_id": "sigir-201427", - "patient": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", - "0": [ - { - "brief_title": "Prospective Randomized Controlled Trial Comparing Water and Air Colonoscopy in a Community Based Setting", - "phase": "", - "drugs": "['Water Exchange Colonoscopy', 'Air Colonoscopy']", - "drugs_list": [ - "Water Exchange Colonoscopy", - "Air Colonoscopy" - ], - "diseases": "['Colon Cancer', 'Tubular Adenoma', 'Hyperplastic Polyp']", - "diseases_list": [ - "Colon Cancer", - "Tubular Adenoma", - "Hyperplastic Polyp" - ], - "enrollment": "178.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u226550 years \n\n Individuals able to provide informed consent \n\n Individuals presenting for average-risk colorectal cancer screening by colonoscopy \n\n Individuals presenting for surveillance of adenomatous/sessile serrated colon polyps as per the US multi-society taskforce on colorectal cancer \n\n ", - "exclusion_criteria": ": \n\n Patients who decline to participate \n\n Prior partial or complete colectomy \n\n Patients with history of inflammatory bowel disease (ulcerative colitis or Crohn's disease) \n\n Patients with prior history of colorectal cancer \n\n Patients with history of screening colonoscopy within the past 10 years \n\n Patients with history of familial polyposis syndromes (Familial Adenomatous Polyposis, Lynch Syndrome)", - "brief_summary": "The purpose of this study is to determine if screening colonoscopy performed on adults with the water exchange method, as opposed to the air method, will have a higher adenoma detection rate.", - "NCTID": "NCT01729416" - }, - { - "brief_title": "Screening and Risk Factors of Colon Neoplasia", - "phase": "", - "drugs": "['Stool DNA Test', 'biopsies of rectal and colon mucosa', 'Questionnaires']", - "drugs_list": [ - "Stool DNA Test", - "biopsies of rectal and colon mucosa", - "Questionnaires" - ], - "diseases": "['Colon Cancer']", - "diseases_list": [ - "Colon Cancer" - ], - "enrollment": "3315.0", - "inclusion_criteria": "inclusion criteria: \n\n patients undergoing routine colonoscopy at University Hospitals, Cleveland Ohio \n\n ", - "exclusion_criteria": ": \n\n Unable to give written consents \n\n Unable to fill the questionnaires \n\n A history of polyps within the past 10 years (except hyperplastic polyps) \n\n Family history of Familial Adenomatous Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC) \n\n Personal history of inflammatory bowel disease \n\n Personal diagnosis of any cancer, with the exception of non-melanoma skin cancer \n\n Any major colon surgeries (e.g. resectioning)", - "brief_summary": "The investigators propose a screening population-based study to systematically evaluate the accuracy and clinical relevance of sDNA testing as a potential alternative to colonoscopy screening. In addition, the investigators propose a genetic epidemiologic study of the relation between colon polyps, an established precursor of colon cancer, and two factors that may influence risk for colon cancer: candidate genes and diet.", - "NCTID": "NCT01647776" - }, - { - "brief_title": "Genetic Study of Familial Factors in Patients With Colon Cancer", - "phase": "", - "drugs": "['cytogenetic analysis', 'gene mapping', 'microarray analysis']", - "drugs_list": [ - "cytogenetic analysis", - "gene mapping", - "microarray analysis" - ], - "diseases": "['Colorectal Cancer']", - "diseases_list": [ - "Colorectal Cancer" - ], - "enrollment": "600.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Diagnosis of colon cancer or polyps at age 70 or under \n\n Has a living full sibling with diagnosis of colon cancer or polyps at age 70 or under \n\n No history of familial adenomatous polyposis syndrome \n\n No hereditary nonpolyposis colon cancer, according to Amsterdam criteria \n\n No known I1370K adenomatous polyposis of the colon susceptibility variant \n\n Enrolled on 1 of the following clinical trials: \n\n CLB-9581 \n\n CLB-89803 \n\n CLB-80001 NOTE: Patients do not need to be receiving protocol therapy. Patients who are outside the treatment protocol's follow-up range are eligible. Patients who discontinued therapy for any reason, including toxic effects, are eligible. \n\n PATIENT CHARACTERISTICS: \n\n Age \n\n 70 and under at diagnosis \n\n Other \n\n No significant psychiatric illness that would preclude giving informed consent \n\n No inflammatory bowel disease (in patient or sibling)", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer.~PURPOSE: Clinical trial to study the cancer-related genes in patients who have colon cancer or adenomatous polyps.", - "NCTID": "NCT00055848" - }, - { - "brief_title": "Adenoma Detection Rate:NBI, AFI, Chromoscopic or Standard Endoscopy", - "phase": "", - "drugs": "['flexible sigmoidoscopy']", - "drugs_list": [ - "flexible sigmoidoscopy" - ], - "diseases": "['Familial Adenomatous Polyposis']", - "diseases_list": [ - "Familial Adenomatous Polyposis" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with Familial adenomatous polyposis who have had ileo-rectal anastomosis and had 20 or less adenomas at previous surveillance examination \n\n ", - "exclusion_criteria": ": \n\n poor bowel preparation, unable or unwilling to give informed consent, under 18 years of age,those with more than 20 adenoma", - "brief_summary": "The purpose of this study is to establish whether new techniques that may make polyps (adenomas) stand out better from the background help increase the number of polyps visible at sigmoidoscopy (telescope test to look inside large bowel) compared to looking with standard sigmoidoscopy alone.", - "NCTID": "NCT00253812" - }, - { - "brief_title": "Comparative Study of Colon Capsule and Virtual Colonoscopy (VICOCA)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Colonic Polyps', 'Adenoma']", - "diseases_list": [ - "Colonic Polyps", - "Adenoma" - ], - "enrollment": "349.0", - "inclusion_criteria": "inclusion criteria: \n\n The main objective in this study is compare two non-invasive techniques in the study of colorectal cancer. When we calculate the sample size we observed that we need more than 1000 patients per group. In this moment this study is very expensive and it is not feasible. Our proposal is include population with a higher prevalence of lesions: individuals with positive FIT (fecal immunochemical test) in which the prevalence of lesions is 60%. In this case, sample size is reduced considerably. \n\n The eligible population will be men and women, 50-69 years old, with no known risk factors and positive FIT. \n\n ", - "exclusion_criteria": ": \n\n Individuals who have symptoms suggestive of colorectal disease (rectorrhagia, change in bowel movement frequency, constitutional syndrome, anaemia). \n\n History of inflammatory bowel disease, colorectal polyposis, colorectal adenoma or CRC, and total or partial colectomy. \n\n History of familial adenomatous polyposis or other hereditary polyposis syndromes; hereditary colorectal cancer not associated with polyposis (diagnosed by the presence of germinal mutation in the DNA repair genes and/or by fulfilment of the Amsterdam II criteria); \n\n Severe co-morbidity that carries a poor short-term prognosis (disease with an average life expectancy of less than 5 years) or a chronic illness that involves significant limitation of physical activity. \n\n Contraindication to undergoing colon capsule or virtual colonoscopy.", - "brief_summary": "Summary Colorectal cancer (CRC) represents the second leading cause of cancer deaths in Spain (11,000 deaths per year). Screening of the population over 50 years of age with no significant history (intermediate risk) is recommended, but which screening method is best for promoting adherence in this type of patient has not been well established. There are currently two screening methods that are less invasive than conventional colonoscopy and seem to have higher sensitivity than the test for faecal occult blood (FOBT). These two methods are the colon capsule, which consists in ingesting a capsule that takes photographs of the colon, and virtual colonoscopy, which is a radiological technique.~Objectives: 1. To demonstrate that virtual colonoscopy and colon capsule are effective CRC screening techniques in the intermediate risk population, with diagnostic rates comparable to conventional colonoscopy (concordance). 2. To compare the diagnostic rates of the colon capsule and virtual colonoscopy with respect to the size and characteristics of the lesions visualised. 3. To compare the participation rates for each screening strategy and identify the factors that influence participation (individual, family, and socioeconomic factors as well as those relating to the doctor).", - "NCTID": "NCT02081742" - }, - { - "brief_title": "To Investigate Risk of Colorectal Neoplasms in First-degree Relatives of Patients With Non-advanced Adenomas", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Colorectal Cancer', 'Colorectal Adenoma']", - "diseases_list": [ - "Colorectal Cancer", - "Colorectal Adenoma" - ], - "enrollment": "828.0", - "inclusion_criteria": "inclusion criteria: \n\n First-degree relatives (aged 40 to 70 years) of individuals diagnosed with non-advanced adenoma on screening colonoscopy as Cases \n\n FDR of patients with negative findings on colonoscopy identified during the same study period, who are of the same age group as the studied as Cohort \n\n ", - "exclusion_criteria": ": \n\n A FDR history of CRC \n\n A family history compatible with that of Hereditary Non-polyposis Colon Cancer (HNPCC) based on the Amsterdam criteria \n\n Known Familial Adenomatous Polyposis (FAP) syndrome \n\n Patients and siblings with known inflammatory bowel disease \n\n Undergone colonoscopy examinations in the past 5 years \n\n Severe cardio-pulmonary or other medical co-morbidities that preclude safe colonoscopic examination \n\n Pregnancy", - "brief_summary": "The risk of CRC in families of patients with CRC is well established, but it is less well-defined for families of patients with adenomas. Screening recommendations to families when an index subject has an adenoma on colonoscopy are not clear. Previous studies demonstrating an increased CRC risk in close relatives of subjects with adenomas were mostly limited by the lack of a suitable comparison group, did not offer colonoscopy to all relatives or did not have verification on true status of adenoma history in the relatives. A systematic review has reported that most studies cited for risk of CRC in relatives with adenomas have not addressed the intended question. Currently International guidelines recommended screening colonoscopy in close relatives and at a younger age when there is a proband with an adenoma, however this recommendation has not been fully supported by all societies due to the lack of robust evidence. This gap in knowledge highlights the need of well-designed and adequately powered studies to estimate the risk of colorectal neoplasms in subjects who have first-degree relatives with adenomas.~Up to 30% of average risk asymptomatic individuals 50 years or older will have at least one adenoma. Based on current guidelines, nearly half the population will be counseled to undergo a colonoscopy from 40 years old based on a positive family history of adenoma. This will have enormous burden on the healthcare system if screening is implicated in all these individuals. Secondly, not all adenomas carry the same risk. Large or villous adenomas are associated with a nearly 70% increased risk of CRC in first degree relatives (FDR) whereas small adenomas may be associated with a modest increased risk 19. It is therefore important to determine the risk of colorectal neoplasms in families of subjects with non-advanced adenomas to justify more intensive screening in these individuals. Investigators hypothesize that first-degree relatives of patients with non-advanced adenoma have an increased risk of both CRC and adenomas. Investigators aim to quantify this risk, and to identify other individual patient or neoplasm characteristics that may contribute to this increased risk. In addition, Investigators aim to determine molecular alteration profiles of colonic adenoma in siblings of patients with advanced neoplasm.", - "NCTID": "NCT02521727" - }, - { - "brief_title": "Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Colonic Neoplasms']", - "diseases_list": [ - "Colonic Neoplasms" - ], - "enrollment": "1200.0", - "inclusion_criteria": "inclusion criteria: \n\n Willing to sign informed consent \n\n Able to physically tolerate removal of up to 60 ml of blood \n\n Adults at least 18 years old \n\n Willing to collect 1-2 stool samples and prepare a Fecal Immunochemical Test (FIT) \n\n Pregnant or nursing women who otherwise meet the eligibility criteria may participate \n\n Subjects with one of the following: \n\n Colorectal adenocarcinoma-not treated and in colon at time of stool collection (CRC bin) \n\n Adenoma-pathologically confirmed adenoma present in colon at time of stool collection (Adenoma Bin) \n\n Higher Risk Non-neoplastic Bin \n\n Subjects with a personal history of adenomas (confirmed by pathology) with none present on qualifying colonoscopy \n\n Subjects with a personal history of CRC (longer than 3 years ago because of ", - "exclusion_criteria": " of cancer within last 3 years) with none present at time of qualifying colonoscopy \n\n Any family history of CRC (1st degree relative) \n\n Current positive screening stool test for blood, for DNA or for both within 12 months with no follow-up intervention. \n\n Average Risk, Non-neoplastic Bin \n\n No history or current finding of any colorectal neoplasia including CRC, adenomas, sessile serrated adenomas and no family history of CRC. \n\n Subjects who had CRC that was successfully treated at least three years ago may be considered eligible for the adenoma bin if their polyps are adenomas and there is no evidence of CRC, or for the higher risk non-neoplastic bin as noted above. \n\n Subjects whose screening colonoscopy shows any of these types of polyps may be included in the non-neoplastic or the higher risk non-neoplastic bin if they meet the other criteria noted above. \n\n Hyperplastic polyps \n\n Benign mucosal polyps \n\n Polypoid granulation tissue \n\n Prolapsed mucosal polyps \n\n Inflammatory polyp \n\n Transitional mucosal polyp \n\n Lipoma \n\n Gangleoneuroma \n\n Neuroma \n\n Hamartomatous polyp \n\n ", - "brief_summary": "Colon cancer is the second most common cancer in men and women. It is a disease that can be prevented if it is found early. Colonoscopy is still the best screening tool for colon cancer and the polyps that turn into colon cancer. However, due to a variety of factors, including affordability, time, and age, not all patients are able to be screened. Researchers are working on other options for early detection that are as accurate as colonoscopy.~The purpose of this study if to determine if stool or blood can be used to detect colon cancers as early or earlier than colonoscopy. The researchers plan to use these samples to learn about specific proteins (also known as biomarkers) that may indicate colon polyps, colon cancer or an increased risk of developing colon cancer. In order to learn more about preventing and detecting colon and rectal cancer, we are collecting samples from subjects with cancer, adenomas, and colonoscopies who may be at risk for polyps.", - "NCTID": "NCT00843375" - }, - { - "brief_title": "Curcumin in Treating Patients With Familial Adenomatous Polyposis", - "phase": "Phase 2", - "drugs": "['Curcumin', 'Laboratory Biomarker Analysis', 'Placebo']", - "drugs_list": [ - "Curcumin", - "Laboratory Biomarker Analysis", - "Placebo" - ], - "diseases": "['Familial Adenomatous Polyposis']", - "diseases_list": [ - "Familial Adenomatous Polyposis" - ], - "enrollment": "44.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with familial adenomatous polyposis who have undergone subtotal colectomy with ileorectal anastomosis, total colectomy with ileo-anal pull through (reservoir), and patients with intact colons with 5 or more adenomas in the rectum-sigmoid or reservoir \n\n Patients with familial adenomatous polyposis (FAP) and duodenal adenomatous polyposis without current lower tract adenomatous polyposis i.e. status/post (s/p) ileostomy \n\n ", - "exclusion_criteria": ": \n\n Female patients of childbearing age not on effective birth control \n\n Pregnant women \n\n White blood cell count (WBC) < 3500/ml \n\n Platelet count < 100,000/ml \n\n Blood urea nitrogen (BUN) > 25mg% \n\n Creatinine > 1.5mg% \n\n Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, curcumin, tumeric, calcium, vitamin D, green tea, or polyphenol E supplements for the duration of the trial \n\n Malignancy other than nonmelanoma skin cancer \n\n Active bacterial infection \n\n Patients with symptoms of active gastroesophageal reflux disease (GERD) (symptomatic despite medication or current erosive esophagitis on endoscopy) \n\n Patients with a history of peptic ulcer disease \n\n Patients on warfarin or plavix", - "brief_summary": "This randomized phase II trial studies curcumin in treating patients with familial adenomatous polyposis. Curcumin may prevent colorectal cancer in patients with a history of rectal polyps or colorectal neoplasia.", - "NCTID": "NCT00641147" - }, - { - "brief_title": "A Trial of Low Dose Sulindac Combined With Eflornithine in Patients With Familial Adenomatous Polyposis (FAP)", - "phase": "Phase 3", - "drugs": "['Eflornithine plus Sulindac', 'Eflornithine plus Placebo', 'Sulindac plus Placebo']", - "drugs_list": [ - "Eflornithine plus Sulindac", - "Eflornithine plus Placebo", - "Sulindac plus Placebo" - ], - "diseases": "['Familial Adenomatous Polyposis']", - "diseases_list": [ - "Familial Adenomatous Polyposis" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of phenotypic Familial Adenomatous Polyposis (FAP) of the colorectum based on meeting the criteria in one of two groups: Group 1-Greater than 100 adenomatous colorectal polyps prior to age 40. Group 2-Greater than 10 adenomatous polyps and age <40 or greater than 25 polyps and age >40; combined with a dominant family history or genotype: More than 100 polyps in a first-degree relative; More than 25 polyps in 2 relatives in 2 generations, including a first-degree family member; Genetic diagnosis in a relative; Genetic diagnosis by in vitro synthesized truncated protein or similar assay. \n\n No colorectal surgery or prior colon surgery for polyposis at least 1 year prior (total abdominal colectomy with ileal-rectal anastomosis, or total proctocolectomy with ilea pouch-anal reconstruction. \n\n Baseline endoscopy \n\n If no prior colorectal surgery, at least 3 polyps in a cluster each \u2265 2 mm in diameter; or \n\n If rectum is in situ and to be assessed, baseline rectal segment endoscopy documenting 3 or more rectal polyps each at least 2 mm in diameter in a defined cluster and/or at least 6 polyps, \u2265 2 mm in diameter, in the distal 10 cm of rectum \n\n If ileal pouch neo-rectum is in place, 3 or more pouch polyps in a cluster \u2265 2 mm in diameter, or at least 6 polyps, \u2265 2 mm in diameter, in the distal 10 cm of pouch. \n\n Clinical/pathological grading of duodenal polyps will utilize the Spigelman Classification. \n\n Hematopoietic: no significant hematologic dysfunction; WBC \u22653,000/mm3; platelet count \u2265100,000/mm3; hemoglobin \u226510g/dL; no known or prior clinical coagulopathy. \n\n Hepatic: bilirubin \u2264 1.5 times ULN; AST and ALT \u2264 1.5 times ULN; Alkaline phosphatase \u2264 1.5 times ULN. \n\n Renal: No significant renal dysfunction; creatinine \u2264 1.5 times ULN. \n\n Hearing: no clinically significant hearing loss that affects everyday life. \n\n Not pregnant or nursing. \n\n Negative serum pregnancy test if female of child-bearing potential. \n\n Absence of gross blood in stool. \n\n Fertile patients must use effective contraception. \n\n Stool occult blood either negative or minimal (1+). \n\n No prior hypersensitivity to cyclooxygenase-2 inhibitors, sulfonamides, NSAIDs, or salicylates; no NSAID associated symptoms of gastritis. \n\n No discrete gastric or duodenal ulcer greater than 5 mm within the past year except Helicobacter pylori-related peptic ulcer disease treated successfully with antibiotics (as documented by an endoscopy. \n\n No invasive malignancy within the past 5 years except stage I or II colon or rectal cancer or resected nonmelanomatous skin cancer. \n\n No other significant medical or psychiatric problems that would preclude study participation. \n\n No chronic adrenocorticosteroids. \n\n No prior pelvic irradiation. \n\n At least 3 months since prior investigational agents. \n\n Patients may not be receiving or plan to receive corticosteroids. \n\n Concomitant NSAID use outside this study may not exceed 4 days per month. \n\n Use of 81 mg daily aspirin or 650 mg aspirin not more than once a week. \n\n No concurrent warfarin, fluconazole, or lithium. \n\n Must be willing and able to sign informed consent. \n\n ", - "exclusion_criteria": ": \n\n High Risk for cardiovascular disease including clinical diabetes mellitus (Type I or II) requiring glycemic medications; Prior personal history of cardiovascular disease or, two or more of the following - hypertension or use of anti-hypertensive medications, hyperlipidemia or use of lipid-lowering medications or current smoker. \n\n Hearing loss that affects everyday life and or for which a hearing aid is required.", - "brief_summary": "The purpose of this phase III study is to evaluate the safety and efficacy of the combination of eflornithine and sulindac compared to single agent sulindac or eflornithine in reducing the number of polyps in patients with familial adenomatous polyposis (FAP).", - "NCTID": "NCT01245816" - }, - { - "brief_title": "Unprepped CT Colonography", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Colorectal Neoplasms']", - "diseases_list": [ - "Colorectal Neoplasms" - ], - "enrollment": "1255.0", - "inclusion_criteria": "inclusion criteria: \n\n Average risk or higher for colorectal cancer and scheduled for colonoscopy with any of the following indications: \n\n Prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency. \n\n Age \u2265 40 -100 years \n\n Known or highly suspected primary colorectal neoplasms > 10 mm (n = 160) \n\n Higher than average risk for colorectal cancer and scheduled for colonoscopy with any of the following indications: prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency. \n\n ", - "exclusion_criteria": ": \n\n Less than 1/2 of colorectum remaining \n\n Inflammatory bowel disease (Crohns, Chronic Ulcerative Colitis) \n\n Familial Polyposis \n\n Melena, hematochezia", - "brief_summary": "It is our objective to improve the performance of CTC in the prepared colon, and to validate CTC in the unprepared colon for the detection of colorectal neoplasia. The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening test.", - "NCTID": "NCT00586053" - }, - { - "brief_title": "Comparison Between White Light Endoscopy and Bright Narrow Band Imaging in Diagnosis Colonic Adenomas.", - "phase": "", - "drugs": "['Bright Narrow Band Imaging.', 'White Light Endoscopy']", - "drugs_list": [ - "Bright Narrow Band Imaging.", - "White Light Endoscopy" - ], - "diseases": "['Colonic Adenomas']", - "diseases_list": [ - "Colonic Adenomas" - ], - "enrollment": "1000.0", - "inclusion_criteria": "inclusion criteria: \n\n Asymptomatic subjects undergoing screening colonoscopy, age > 50, average risk subjects and, ability to provide a written consent to trial participation. \n\n ", - "exclusion_criteria": ": \n\n personal history of inflammatory bowel disease, colon adenoma or cancer \n\n family history of FAP or Familial nonpolyposis syndrome \n\n first degree relatives having diagnosed to have colorectal carcinoma \n\n no colonoscopy in past 5 years", - "brief_summary": "Removal of colorectal adenomas prevents the occurence of colorectal cancers. The use of chromo-endoscopy has been shown to improve the detection of flat adenomas. Narrow band imaging enables endoscopists to accurately describe the pit pattern of adenomas. By comparing White Light Endoscopy and Bright Narrow Band Imaging it will show if there is any comparable advantage to using one or the other for lesion detection and assessment.", - "NCTID": "NCT01737567" - }, - { - "brief_title": "Diagnosis of Colonic Adenomas by Bright Narrow Band Imaging (B-NBI)", - "phase": "", - "drugs": "['Bright Narrow Band Imaging', 'White light Endoscopy']", - "drugs_list": [ - "Bright Narrow Band Imaging", - "White light Endoscopy" - ], - "diseases": "['Colonic Adenomas']", - "diseases_list": [ - "Colonic Adenomas" - ], - "enrollment": "1006.0", - "inclusion_criteria": "inclusion criteria: \n\n Asymptomatic subjects undergoing screening colonoscopy \n\n age > 40 \n\n average risk subjects defined as those without a personal history of inflammatory bowel disease, colon adenoma or cancer or family history of Familial adenomatous polyposis (FAP) or Familial non-polyposis syndrome or first degree relatives having diagnosed to have colo-rectal carcinoma \n\n no colonoscopy in past 5 years \n\n ability to provide a written consent to trial participation \n\n ", - "exclusion_criteria": ": \n\n Patient age < 50 \n\n Patients with prior colorectal surgery \n\n Pregnant or lactating women \n\n Colonoscopy done within the past 5 years \n\n Lack of consent", - "brief_summary": "Early detection of colo-rectal adenoma using colonoscopy can prevent occurrence of colon cancers. While colonoscopy is a standard technique, it can miss early cancers. To improve the detection rate, Narrow Band Imaging (NBI) was introduced in 2006. It has been shown to compare favorably with chromo-endoscopy in the sensitivity and specificity in the diagnosis of malignant colo-rectal neoplasms. The major drawback of NBI is that images become dark in the presence of blood and fecal matters. The bright-NBI is a prototype imaging technology that enables endoscopists to obtain better images in suboptimal conditions. The study proposes to compare the performance of colonoscopy using either white light or bright NBI in subjects undergoing screening colonoscopy in search for colon adenomas.~Purpose~To determine that bright -NBI is superior to WLE in detecting colorectal adenomas in average risk subjects undergoing screening colonoscopy.", - "NCTID": "NCT01422577" - }, - { - "brief_title": "I-Scan Vs High Definition White Light (Main Study)", - "phase": "", - "drugs": "['HD Colon', 'I-scan 1', 'I-Scan 2']", - "drugs_list": [ - "HD Colon", - "I-scan 1", - "I-Scan 2" - ], - "diseases": "['Colorectal Cancer']", - "diseases_list": [ - "Colorectal Cancer" - ], - "enrollment": "1500.0", - "inclusion_criteria": "inclusion criteria: \n\n All increased risk patients (Patients with family history or personal history of colon polyps or colon cancer and FOBT positive) referred for a screening colonoscopy at the Forzani and MacPhail Colon Cancer Screening Centre will be considered for enrollment. \n\n ", - "exclusion_criteria": ": \n\n Average Risk patients \n\n Previous colon surgery \n\n Hereditary Polyposis Syndromes \n\n Suspected polyps or CRC before colonoscopy that have been suggested by another modality (Barium Enema, Virtual Colonoscopy, Flexible Sigmoidoscopy)", - "brief_summary": "The purpose of this study is to assess whether the use of I-Scan during colonoscopy leads to an increased yield of adenomas in the colon among a population at increased risk for CRC.~Primary Outcome:~Adenoma Detection Rate (ADR - No. of colonoscopies at which one or more histologically confirmed adenomas were found divided by the total no. of colonoscopies performed in the same time period) in the right colon using High Definition White Light Colonoscopy Versus I-Scan enhanced Colonoscopy.~Secondary Outcomes:~Adenoma Detection Rate (ADR) of High Definition White Light Colonoscopy Versus I-Scan colonoscopy through out the entire colon.~Adenoma Detection Rate (ADR) in the right colon during the Second look, irrespective of imaging modality.~Polyp Detection Rate (PDR - No. of colonoscopies at which one or more polyps were found(regardless of the histological type) divided by the total no. of colonoscopies performed in the Same time period) for each arm of the study in Right colon and throughout the entire colon.~Mean number of adenomas per procedure for each arm of the study in right colon and throughout the entire colon.~Mean number of polyps per procedure for each arm of the study in right colon and throughout the entire colon.~Number of neoplastic lesions for each arm of the study in the right colon and throughout the entire colon and number of neoplastic lesions missed on 1st pass of right colon.~Proportion of patients with diminutive lesions (< 5 mm) in each arm of the study~Proportion of patients with Flat lesions (height < 1/2 diameter) in each arm of the study~Proportion of patients with Sessile Serrated Adenoma in each arm of the study~Proportion of patients with invasive cancer in each arm of the study~Presence or absence of learning effect while using this technology given that use of I-Scan may train the human eye to better identify adenomas even without image enhancement.", - "NCTID": "NCT02016326" - }, - { - "brief_title": "Efficacy Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia", - "phase": "Phase 4", - "drugs": "['FIT-sigmoidoscopy', 'Colonoscopy']", - "drugs_list": [ - "FIT-sigmoidoscopy", - "Colonoscopy" - ], - "diseases": "['Colorectal Adenoma']", - "diseases_list": [ - "Colorectal Adenoma" - ], - "enrollment": "5282.0", - "inclusion_criteria": "inclusion criteria: \n\n Asymptomatic subjects aged 45 - 75 years \n\n Subjects who will give the written consent \n\n ", - "exclusion_criteria": ": \n\n Subjects with past history of colorectal cancer \n\n Subjects with familial histories of familial adenomatous polyposis(FAP) or Hereditary nonpolyposis colorectal cancer(HNPCC) \n\n Subjects with familial history of colorectal cancer more than 2 familial member in direct line \n\n Subjects with inflammatory bowel disease(IBD) \n\n Subjects with more than 3 point of American Society of Anesthesiologists (ASA) physical classification \n\n Subjects with past history of colectomy \n\n Subjects with history of colonoscopy within 5 years \n\n Subjects with history of sigmoidoscopy within 3 years \n\n Subjects with history of CT colonoscopy within 10 years \n\n Subjects with symptoms that could present the colorectal cancer such as hematochezia, melena, weight loss more than 10kg/6months", - "brief_summary": "The purpose of this study is to evaluate the efficacy and cost-effectiveness of fecal immunochemical test combined with sigmoidoscopy (FITS) for the detection of advanced colorectal neoplasia compared to colonoscopy.", - "NCTID": "NCT01767870" - }, - { - "brief_title": "Chromoendoscopy to Decrease the Risk of Colorectal Neoplasia in Lynch Syndrome", - "phase": "", - "drugs": "['Chromoendoscopy']", - "drugs_list": [ - "Chromoendoscopy" - ], - "diseases": "['Lynch Syndrome']", - "diseases_list": [ - "Lynch Syndrome" - ], - "enrollment": "240.0", - "inclusion_criteria": "inclusion criteria: \n\n proven carrier of a MLH1, MSH2 or MSH6 mutation \n\n age between 20 and 70 years \n\n written informed consent \n\n ", - "exclusion_criteria": ": \n\n previous large bowel surgery \n\n psychological/physical conditions hampering compliance with the study protocol", - "brief_summary": "Lynch syndrome (LS), or hereditary nonpolyposis colorectal cancer (HNPCC), is a hereditary disorder predisposing for colorectal cancer. To reduce the risk of colorectal cancer, patients undergo colonoscopy every 1-2 years. Chromoendoscopy is relatively new technique which improves the detection of adenomas, the precursor lesions of colorectal cancer. The aim of this study is to determine whether chromoendoscopy, including polypectomy of all detected lesions, reduces the development of colorectal neoplasia and the need for colectomy in LS patients.", - "NCTID": "NCT00905710" - }, - { - "brief_title": "Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis", - "phase": "Phase 2", - "drugs": "['Sulindac (drug)', 'VSL#3 (probiotic)', 'Inulin (probiotic)']", - "drugs_list": [ - "Sulindac (drug)", - "VSL#3 (probiotic)", - "Inulin (probiotic)" - ], - "diseases": "['Adenomatous Polyposis Coli']", - "diseases_list": [ - "Adenomatous Polyposis Coli" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinically or genetically proven familial adenomatous polyposis \n\n Restorative proctocolectomy with ileal pouch anal anastomosis \n\n ", - "exclusion_criteria": ": \n\n Chronic or acute renal or hepatic disease \n\n History of oesophageal, gastric or duodenal ulcers \n\n Known hypersensitivity to sulindac \n\n Daily use during the last three months of: \n\n Aspirin \n\n Non-Steroidal Anti-Inflammatory Agents \n\n Probiotics", - "brief_summary": "The purpose of this study is to determine whether sulindac and VSL#3 - inulin, either combined or alone, are effective in treating or preventing adenoma development in the ileal anal pouch in patients with familial adenomatous polyposis.", - "NCTID": "NCT00319007" - }, - { - "brief_title": "Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas", - "phase": "", - "drugs": "['Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD']", - "drugs_list": [ - "Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD" - ], - "diseases": "['Polyps']", - "diseases_list": [ - "Polyps" - ], - "enrollment": "177.0", - "inclusion_criteria": "inclusion criteria: \n\n Cases - Patients who were diagnosed with or underwent resection of a duodenal adenoma/ampulloma at Westmead hospital between the years 2005-2014. \n\n Controls - Patients undergoing VCE procedure for the evaluation of obscure gastrointestinal bleeding (OGIB) or Iron deficiency anemia (IDA). \n\n ", - "exclusion_criteria": ": \n\n None", - "brief_summary": "Little is known about the prevalence of small bowel polyps in patients with sporadic Duodenal/Ampullary polyps. The investigators aim to investigate the prevalence of small bowel polyps in patients with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas by performing small bowel capsule endoscopy and comparing the results to those acquired from a control cohort undergoing VCE for accepted indication at our centre.", - "NCTID": "NCT02470416" - }, - { - "brief_title": "Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses", - "phase": "", - "drugs": "['GORE SEAMGUARD\u00ae Bioabsorbable Staple Line Reinforcement', 'Staple line without reinforcement']", - "drugs_list": [ - "GORE SEAMGUARD\u00ae Bioabsorbable Staple Line Reinforcement", - "Staple line without reinforcement" - ], - "diseases": "['Rectal Cancer', 'Ulcerative Colitis', 'Familial Adenomatous Polyposis', 'Diverticulitis']", - "diseases_list": [ - "Rectal Cancer", - "Ulcerative Colitis", - "Familial Adenomatous Polyposis", - "Diverticulitis" - ], - "enrollment": "258.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects who will undergo restorative proctectomy or proctocolectomy (<10 cm from anal verge) with a low circular stapled colorectal, coloanal or ileoanal anastomosis with or without reservoir, including treatment for rectal cancer, ulcerative colitis, familial adenomatous polyposis \n\n , diverticulitis, perforation of the bowel/trauma. \n\n Subjects undergoing Hartmann's reversal with restorative proctectomy (<10 cm from the anal verge). \n\n Subjects may or may not have a diverting loop ileostomy as a component of their initial surgery. \n\n Subjects who meet the requirements of number 1 and 2, and are being treated for rectal cancer may or may not have preoperative chemoradiation therapy in the treatment of their rectal cancer. \n\n ", - "exclusion_criteria": ": \n\n Subjects being treated for rectal cancer with a diagnosis of inflammatory bowel disease. \n\n Subjects who have significant intraoperative hypotension or cardiac events. \n\n Subjects with collagen vascular disease, coagulopathy, significant renal or hepatic dysfunction (creatinine >1.6 or liver enzymes > 50% upper limit of normal values).", - "brief_summary": "The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced colorectal, coloanal and ileoanal techniques with respect to the incidence of postoperative anastomotic leakage, anastomotic stricture and time to ileostomy closure, if applicable.", - "NCTID": "NCT00663819" - }, - { - "brief_title": "Is Diverting Ileostomy Necessary in Stapled Ileoanal Pouch?", - "phase": "", - "drugs": "['adding diverting ileostomy', 'omitting diverting ileostomy']", - "drugs_list": [ - "adding diverting ileostomy", - "omitting diverting ileostomy" - ], - "diseases": "['Ulcerative Colitis', 'Familial Adenomatous Polyposis']", - "diseases_list": [ - "Ulcerative Colitis", - "Familial Adenomatous Polyposis" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n patients having total proctocolectomy with ileal pouch anal anastomosis. \n\n ", - "exclusion_criteria": ": \n\n hypoalbuminemia \n\n prolonged steroid use \n\n anemia \n\n anastomosis under tension \n\n leak with air test \n\n bleeding \n\n poor vascular supply of anastomosis", - "brief_summary": "Total proctocolectomy with ileal pouch anal anastomosis is the first choice surgical operation for management of ulcerative colitis and familial adenomatous polyposis. The addition of diverting ileostomy may reduce septic complications. In this randomized study the investigators compare two groups of patients with stapled ileoanal pouch one of them had diverting ileostomy and in the other this step is omitted.", - "NCTID": "NCT01173250" - }, - { - "brief_title": "Studying Fibroblast Activity in Patients With Localized Pancreatic Cancer Undergoing Surgery", - "phase": "", - "drugs": "['protein expression analysis', 'western blotting', 'immunohistochemistry staining method', 'immunologic technique', 'laboratory biomarker analysis']", - "drugs_list": [ - "protein expression analysis", - "western blotting", - "immunohistochemistry staining method", - "immunologic technique", - "laboratory biomarker analysis" - ], - "diseases": "['Pancreatic Cancer']", - "diseases_list": [ - "Pancreatic Cancer" - ], - "enrollment": "37.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Biopsy-proven adenocarcinoma of the pancreas or pancreatic mass suspicious for pancreatic cancer \n\n Localized disease \n\n Scheduled to undergo a resection or exploration of their pancreatic tumor \n\n PATIENT CHARACTERISTICS: \n\n Not specified \n\n PRIOR CONCURRENT THERAPY: \n\n See Disease Characteristics", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~PURPOSE: This research study is assessing fibroblast activity in patients with localized pancreatic cancer undergoing surgery.", - "NCTID": "NCT00900016" - }, - { - "brief_title": "Glucomannan for the Treatment of Abdominal Pain-related Functional Gastrointestinal Disorders in Childhood", - "phase": "Phase 4", - "drugs": "['Glucomannan', 'placebo']", - "drugs_list": [ - "Glucomannan", - "placebo" - ], - "diseases": "['Functional Gastrointestinal Disorders']", - "diseases_list": [ - "Functional Gastrointestinal Disorders" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria: \n\n abdominal pain related disorder (functional dyspepsia, irritable bowel syndrome or functional abdominal pain (FAPS) diagnosed according to Rome III criteria. \n\n ", - "exclusion_criteria": ": \n\n organic gastrointestinal disease (as established by medical history, complete blood count, urinalysis, stool examination for occult blood, ova and parasites, blood chemistries, abdominal ultrasound, breath hydrogen testing and endoscopy, if needed) \n\n other chronic disease \n\n growth failure", - "brief_summary": "Background: Functional abdominal pain disorders (FAPD) are common in school-aged children; however, there is no reliable treatment.~Aim: To determine the efficacy and safety of glucomannan for treating FAPD in children.~Trial Setting: Department of Pediatrics, The Medical University of Warsaw.~Intervention: Patients will be enrolled in a double-blind, randomized controlled trial in which they will receive either glucomannan (10g) or placebo for 4 weeks.", - "NCTID": "NCT01495806" - }, - { - "brief_title": "Re-directed T Cells for the Treatment (FAP)-Positive Malignant Pleural Mesothelioma", - "phase": "Phase 1", - "drugs": "['Adoptive Transfer of re-directed T cells']", - "drugs_list": [ - "Adoptive Transfer of re-directed T cells" - ], - "diseases": "['Malignant Pleural Mesothelioma']", - "diseases_list": [ - "Malignant Pleural Mesothelioma" - ], - "enrollment": "4.0", - "inclusion_criteria": "inclusion criteria: \n\n Histologically or cytologically confirmed and documented malignant pleural mesothelioma with pleural effusion, \n\n Signed Informed Consent after being informed, \n\n Patients medically and/or functionally at screening not accessible for surgical treatment \n\n Bone marrow function: hemoglobin >/= 100 g/L; white blood cell count (WBC) >/= 1.0 x 109/L; absolute neutrophile count (ANC) >/= 0.5 x 109/L; platelet count >/= 100 x 109/L, \n\n Hepatic: aspartate transaminase (AST) and alanine transaminase (ALT) 80 years old \n\n history of non adenomatous polyps \n\n history of Metastatic CRC \n\n familial adenomatous polyposis, Peutz-Jeghers syndrome, hereditary non polyposis colorectal cancer (HNPCC), juvenile polyposis syndrome \n\n Familial history of familial adenomatous polyposis \n\n Personal history of subtotal colectomy (but not of hemicolectomy, to confer to inclusion criteria) \n\n Colonoscopy with a polyps resection dated more than 5 years and less than 2 years prior to enrollment. \n\n Enrollment in another protocol \n\n no health insurance affiliation Family histories \n\n Age < 18 or >80 years old \n\n Patients with one or several family histories of first degree colorectal cancer occured to unknown age or diagnosed after 60 years old. \n\n Eligible patients having already undergone colonoscopy screening \n\n no health insurance affiliation", - "brief_summary": "to evaluate the acceptability of CT-colonography compared to colonoscopy for the detection of advanced adenomas in subpopulations at high risk of colorectal.", - "NCTID": "NCT00748449" - }, - { - "brief_title": "Celecoxib in Preventing Colorectal Cancer in Young Patients With a Genetic Predisposition for Familial Adenomatous Polyposis", - "phase": "Phase 1", - "drugs": "['celecoxib', 'placebo']", - "drugs_list": [ - "celecoxib", - "placebo" - ], - "diseases": "['Colorectal Cancer', 'Precancerous Condition']", - "diseases_list": [ - "Colorectal Cancer", - "Precancerous Condition" - ], - "enrollment": "22.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Diagnosis of familial adenomatous polyposis (FAP) based on genetic predisposition testing \n\n Genotype-positive FAP (pathologic Adenomatous polyposis coli (APC) mutation) \n\n No attenuated FAP genotype, defined by any of the following: \n\n Mutation at the 5' end of APC and exon 4 \n\n Exon 9-associated phenotypes \n\n 3' region mutations \n\n Has an intact colon \n\n No requirement for colectomy \n\n Parent(s) do not desire colectomy (regardless of adenoma burden) \n\n Colorectal adenoma burden as assessed by baseline colonoscopy \n\n No diagnosis of severe dysplasia or greater \n\n No more than 10 adenomas \u2265 1 cm \n\n No more than 100 adenomas of any size \n\n No evidence of anemia (hematocrit < 33%) \n\n No new diagnosis of carcinoma \n\n PATIENT CHARACTERISTICS: \n\n White Blood Count (WBC) > 3,000/\u03bcL \n\n Platelet count > 100,000/\u03bcL \n\n Hemoglobin > 10.0 g/dL \n\n Aspartate aminotransferase/alanine aminotransferase (AST/ALT) < 1.5 times upper limit of normal (ULN) \n\n Alkaline phosphatase < 1.5 times ULN \n\n Total bilirubin < 1.5 times ULN \n\n Creatinine < 1.5 times ULN \n\n Not pregnant or nursing \n\n Negative pregnancy test \n\n Fertile patients must use effective contraception \n\n No history of hypersensitivity to COX-2 inhibitors, sulfonamides, NSAIDs, or salicylates \n\n No history of peptic ulcer disease \n\n No significant medical or psychiatric problem that, in the opinion of the principal investigator, would make the patient a poor candidate for the study \n\n No other unacceptable clinical risk (e.g., previously unknown bleeding diatheses) \n\n No invasive carcinoma within the past 5 years \n\n PRIOR CONCURRENT THERAPY: \n\n More than 3 months since prior investigational agent \n\n More than 6 months since prior chemotherapy \n\n No prior radiotherapy to the pelvis \n\n At least 3 months since prior NSAIDs (at any dose) at a frequency of \u2265 3 times/week \n\n At least 1 month since prior NSAIDs (at any dose) at a frequency of < 3 times/week \n\n At least 1 month since prior nasal steroids \n\n Concurrent Nonsteroidal Antiinflammatory Drugs (NSAIDs) allowed provided they are administered \u2264 5 times per month \n\n Concurrent orally inhaled steroids allowed provided they are administered for \u2264 4 weeks over a 6-month period \n\n Concurrent oral or intravenous (IV) corticosteroids allowed provided they are administered for \u2264 2 consecutive weeks over a 6-month period \n\n Concurrent proton pump inhibitors to treat gastric reflux allowed \n\n No concurrent nasal steroids except mometasone (Nasonex) \n\n No concurrent fluconazole, lithium, or adrenocorticosteroids", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of celecoxib may keep polyps and colorectal cancer from forming in patients with familial adenomatous polyposis.~PURPOSE: This randomized phase I trial is studying the side effects and best dose of celecoxib in treating young patients with a genetic predisposition for familial adenomatous polyposis.", - "NCTID": "NCT00685568" - }, - { - "brief_title": "Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis", - "phase": "Phase 2; Phase 3", - "drugs": "['Celecoxib', 'Ursodeoxycholic acid', 'Placebo']", - "drugs_list": [ - "Celecoxib", - "Ursodeoxycholic acid", - "Placebo" - ], - "diseases": "['Familial Adenomatous Polyposis', 'Duodenal Neoplasms', 'Duodenal Polyps']", - "diseases_list": [ - "Familial Adenomatous Polyposis", - "Duodenal Neoplasms", - "Duodenal Polyps" - ], - "enrollment": "37.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with Familial adenomatous Polyposis: APC-mutation identified or more than 100 colorectal polyps on diagnosis \n\n Spigelman score of duodenal adenoma equal to II or III \n\n ", - "exclusion_criteria": ": \n\n Incapability of signing informed consent \n\n Active gastric or duodenal ulcer, gastrointestinal bleeding \n\n Cardiovascular disease or risk: \n\n Congestive cardiac failure: NYHA class II to IV \n\n Proven ischemic heart disease and/or cerebrovascular disease \n\n Risk factors: hypertension, hyperlipidaemia, diabetes mellitus, family history of cardiovascular events (\u22652 first degree family members <55 years) \n\n Renal dysfunction: creatinine clearance below 50mL/min \n\n Liver dysfunction: albumin below 25 g/L or Child-Pugh-score equal to or below 10 \n\n Known allergic reaction to sulfonamides, NSAIDs or ursodeoxycholic acid \n\n Use of NSAIDs or ursodeoxycholic acid for more than 1 week during the 6 months prior to the start of the study \n\n Use of lithium \n\n Symptomatic gallstones \n\n Inflammatory bowel disease \n\n (Possible) pregnancy or breast feeding", - "brief_summary": "Duodenal carcinomas are the leading cause of mortality in patients with Familial Adenomatous Polyposis (FAP) who underwent prophylactic colorectal surgery. The purpose of this study is to determine wether celecoxib combined with ursodeoxycholic acid is an effective chemoprevention strategy to influence the progression of duodenal adenomas to carcinomas in patients with FAP.", - "NCTID": "NCT00808743" - }, - { - "brief_title": "Molecular Fluorescence Endoscopy in Patients With Familial Adenomatous Polyposis, Using Bevacizumab-IRDye800CW", - "phase": "Phase 1", - "drugs": "['Bevacizumab-IRDye800CW', 'Near infrared fluorescence endoscopy platform']", - "drugs_list": [ - "Bevacizumab-IRDye800CW", - "Near infrared fluorescence endoscopy platform" - ], - "diseases": "['Adenomatous Polyposis Coli']", - "diseases_list": [ - "Adenomatous Polyposis Coli" - ], - "enrollment": "17.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with genetically or clinically proven Familial Adenomatous Polyposis. Genetically proven: Adenomatous Polyposis Coli (APC)-mutation identified. Clinically proven: more than 100 colorectal polyps at diagnosis \n\n Age 18 to 70 years \n\n Written informed consent \n\n Adequate potential for follow-up \n\n ", - "exclusion_criteria": ": \n\n Medical or psychiatric conditions that compromise the patient's ability to give informed consent \n\n Proctocolectomy \n\n MutYH mutation \n\n Concurrent uncontrolled medical conditions \n\n Pregnant or lactating women. Documentation of a negative pregnancy test must be available for woman of childbearing potential. Woman of childbearing potential are pre-menopausal women with intact reproductive organs and women less than two years after menopause.", - "brief_summary": "There is a need for better visualization of polyps during surveillance endoscopy in patients with hereditary colon cancer syndromes like Familial Adenomatous Polyposis (FAP) and Lynch Syndrome (LS), to improve the adenoma detection rate. Optical molecular imaging of adenoma associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF) is overexpressed in adenomatous colon tissue versus normal tissue and has proven to be a valid target for molecular imaging. The University Medical Center Groningen (UMCG) developed a fluorescent tracer by labeling the VEGF-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the fluorescent dye IRDye800CW. The investigators hypothesize that when bevacizumab-IRDye800CW is administered to patients, it accumulates in VEGF expressing adenomas, enabling adenoma visualization using a newly developed near-infrared (NIR) fluorescence endoscopy platform (NL43407.042.13). This hypothesis will be tested in this feasibility study, next to the determination of the optimal tracer dose.", - "NCTID": "NCT02113202" - }, - { - "brief_title": "Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis", - "phase": "Phase 2; Phase 3", - "drugs": "['exisulind']", - "drugs_list": [ - "exisulind" - ], - "diseases": "['Colorectal Cancer', 'Small Intestine Cancer']", - "diseases_list": [ - "Colorectal Cancer", - "Small Intestine Cancer" - ], - "enrollment": "0.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n One of the following diagnosis: \n\n Diagnosis of familial adenomatous polyposis \n\n Prior total or subtotal colectomy \n\n Attenuated adenomatous polyposis coli \n\n May have colon intact \n\n 10-40 duodenal polyps from second portion to 10 cm distal to papilla of Vater \n\n PATIENT CHARACTERISTICS: \n\n Age: \n\n 18 to 80 \n\n Performance status: \n\n Not specified \n\n Life expectancy: \n\n Not specified \n\n Hematopoietic: \n\n Hemoglobin at least 10 g/dL \n\n Platelet count at least 100,000/mm^3 \n\n No active hematologic disease \n\n Hepatic: \n\n AST and ALT less than 1.5 times upper limit of normal (ULN) \n\n Alkaline phosphatase less than 1.5 times ULN \n\n No active hepatic disease \n\n Renal: \n\n Creatinine less than 1.5 mg/dL \n\n No active renal disease \n\n Other: \n\n Not pregnant or nursing \n\n Negative pregnancy test \n\n Fertile patients must use effective contraception \n\n No active peptic ulcer disease \n\n No serious underlying medical or psychiatric illness that would preclude completion of the study or limit survival \n\n No prisoners or institutionalized patients \n\n No known allergy to sulindac or related compounds \n\n No active internal malignancy within the past 5 years \n\n No alcohol or drug abuse within the past 5 years \n\n PRIOR CONCURRENT THERAPY: \n\n Biologic therapy: \n\n Not specified \n\n Chemotherapy: \n\n Not specified \n\n Endocrine therapy: \n\n Not specified \n\n Radiotherapy: \n\n Not specified \n\n Surgery: \n\n See Disease Characteristics \n\n Other: \n\n No prior non-steroidal anti-inflammatory drugs (NSAIDs) or salicylates more than 10 days a month for the past 3 months \n\n No concurrent NSAIDs (e.g., mesalamine, olsalazine, azodisalicylate, salsalate, sulfasalazine) \n\n Aspirin for cardiac reasons allowed (81 mg/day or 325 mg twice/week)", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Exisulind may be effective in preventing the development and growth of polyps in patients who have familial adenomatous polyposis.~PURPOSE: Randomized phase II/III trial to determine the effectiveness of exisulind in preventing the development and growth of polyps in patients who have familial adenomatous polyposis.", - "NCTID": "NCT00026468" - }, - { - "brief_title": "Lyophilized Black Raspberries in Adults With Familial Adenomatous Polyposis (FAP)", - "phase": "Phase 1", - "drugs": "['Black raspberry (BRB) Slurry', 'Black Raspberry (BRB) Suppositories', 'Black Raspberry (BRB) Placebo Slurry']", - "drugs_list": [ - "Black raspberry (BRB) Slurry", - "Black Raspberry (BRB) Suppositories", - "Black Raspberry (BRB) Placebo Slurry" - ], - "diseases": "['Familial Adenomatous Polyposis']", - "diseases_list": [ - "Familial Adenomatous Polyposis" - ], - "enrollment": "34.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of familial adenomatous polyposis with at least 5 rectal polyps which are greater than or equal to 2 mm on baseline colonoscopy \n\n Have an endoscopically assessable rectal segment \n\n Have not taken NSAIDs or selective COX-2 inhibitors for two months prior to the study and willing to remain off NSAIDs for the study duration. \n\n ", - "exclusion_criteria": ": \n\n Known allergies or hypersensitivity to berries \n\n Diabetes mellitus \n\n Subjects taking NSAIDs or COX-2 inhibitors who cannot be taken off the medication due to their clinical condition.", - "brief_summary": "This is a 36 week dietary intervention pilot study to evaluate the effects of lyophilized black raspberries on rectal polyp burden and biomarkers in subjects with FAP. Subjects will undergo a colonoscopy or sigmoidoscopy before study treatment to determine eligibility for the study. Eligible participants will undergo a sigmoidoscopy at 36 weeks after the initiation of study treatment. The size and number of rectal polyps will be documented on a code sheet and by photograph. The efficacy outcome will include the percentage reduction in the number of rectal polyps between baseline and 36 weeks.", - "NCTID": "NCT00770991" - }, - { - "brief_title": "APACC Study:Prospective Study on Aspirin Efficacy in Reducing Colorectal Adenoma Recurrence", - "phase": "Phase 3", - "drugs": "['Aspirin']", - "drugs_list": [ - "Aspirin" - ], - "diseases": "['Colon Adenomas']", - "diseases_list": [ - "Colon Adenomas" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients are aged between 18 and 75 years At least 3 adenomas irrespective size or at least one measuring 6mm or more All subjects had a clean colon at the study entry \n\n ", - "exclusion_criteria": ": \n\n No personal history of colon cancer, no inflammatory bowel disease, no familial adenomatous polyposis, no regular use of aspirin", - "brief_summary": "Experimental and epidemiologic studies have suggested that aspirin intake reduces the risk for colorectal cancer. In the APACC study we randomly assigned 291 patients to daily Aspirin or Placebo for 4 years. However, the available data are not sufficient to serve as the basis for firm recommendations", - "NCTID": "NCT00224679" - }, - { - "brief_title": "APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis", - "phase": "Phase 3", - "drugs": "['patisiran (ALN-TTR02)', 'Sterile Normal Saline (0.9% NaCl)']", - "drugs_list": [ - "patisiran (ALN-TTR02)", - "Sterile Normal Saline (0.9% NaCl)" - ], - "diseases": "['TTR-mediated Amyloidosis', 'Amyloidosis, Hereditary', 'Amyloid Neuropathies, Familial', 'Familial Amyloid Polyneuropathies', 'Amyloid Neuropathies', 'Amyloidosis, Hereditary, Transthyretin-Related']", - "diseases_list": [ - "TTR-mediated Amyloidosis", - "Amyloidosis", - "Hereditary", - "Amyloid Neuropathies", - "Familial", - "Familial Amyloid Polyneuropathies", - "Amyloid Neuropathies", - "Amyloidosis", - "Hereditary", - "Transthyretin-Related" - ], - "enrollment": "225.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female of 18 to 85 years of age (inclusive); \n\n Have a diagnosis of FAP \n\n Neuropathy Impairment Score requirement of 5-130 \n\n Meet Karnofsky performance status requirements \n\n Have adequate complete blood counts and liver function tests \n\n Have adequate cardiac function \n\n Have negative serology for hepatitis B virus (HBV) and hepatitis C virus (HCV) \n\n ", - "exclusion_criteria": ": \n\n Had a prior liver transplant or is planned to undergo liver transplant during the study period; \n\n Has untreated hypo- or hyperthyroidism; \n\n Has known human immunodeficiency virus (HIV) infection; \n\n Had a malignancy within 2 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated; \n\n Recently received an investigational agent or device \n\n Is currently taking diflunisal, tafamidis, doxycycline, or tauroursodeoxycholic acid", - "brief_summary": "The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in patients with transthyretin (TTR) mediated amyloidosis. An open-label, single-arm, long-term follow-up extension study NCT02510261 (ALN-TTR02-006) was initiated to provide participants who completed this study with continued patisiran-LNP (lipid nanoparticle) treatment.", - "NCTID": "NCT01960348" - } - ], - "2": [ - { - "brief_title": "High Definition Endoscopy With i-Scan for Small Colonic Polyp Evaluation: The HiScope Study", - "phase": "", - "drugs": "['High definition white light endoscopy']", - "drugs_list": [ - "High definition white light endoscopy" - ], - "diseases": "['Colonic Polyps']", - "diseases_list": [ - "Colonic Polyps" - ], - "enrollment": "84.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients found to have colonic polyps up to 10mm in size \n\n ", - "exclusion_criteria": ": \n\n Poor bowel preparation \n\n Inflammatory bowel disease \n\n Polyposis syndrome", - "brief_summary": "Current standard practice is to remove all colonic polyps found during colonoscopy as it has not been possible to distinguish between polyps with some malignant potential (adenomatous) and those with negligable malignant potential (non-adenomatous).~Recent advances in endoscope imaging and technology have allowed endoscopists to distinguish between these two types of polyps by examining minute surface details.~i-Scan is a new digital enhancement method that aims to enhance surface details and may enable similar accurate distinction between adenomatous and non-adenomatous polyps.~Hypothesis:~High definition white light endoscopy plus i-Scan improves diagnostic accuracy of in-vivo assessment of colonic polyps <10mm in size over high definition white light endoscopy alone.", - "NCTID": "NCT01761279" - }, - { - "brief_title": "Multimedia Intervention in Patients With Familial Adenomatous Polyposis (FAP)", - "phase": "", - "drugs": "['Web-Based Multimedia Intervention', 'Questionnaire']", - "drugs_list": [ - "Web-Based Multimedia Intervention", - "Questionnaire" - ], - "diseases": "['Familial Adenomatous Polyposis', 'Colorectal Cancer']", - "diseases_list": [ - "Familial Adenomatous Polyposis", - "Colorectal Cancer" - ], - "enrollment": "31.0", - "inclusion_criteria": "Eligibility: (List All Criteria) \n\n inclusion criteria: \n\n 1) Having a confirmed genetic or clinical diagnosis of FAP between the age of 13-24 at the time of recruitment to this study. \n\n 18-21 year old with a previous cancer diagnosis. \n\n Able to read and speak English. \n\n ", - "exclusion_criteria": ": \n\n 1) n/a", - "brief_summary": "The goal of this research study is to test the first version of a website that will offer information and support for adolescents and young adults with FAP. Researchers want to see if the website will be helpful, easy to understand, and easy to use for young patients with FAP.", - "NCTID": "NCT00525655" - }, - { - "brief_title": "The Utility of Time Segmental Withdrawal During Screening Colonoscopy for Increasing Adenoma Detection Rate.", - "phase": "", - "drugs": "['Segmental withdrawal']", - "drugs_list": [ - "Segmental withdrawal" - ], - "diseases": "['Adenomatous Polyp of Colon']", - "diseases_list": [ - "Adenomatous Polyp of Colon" - ], - "enrollment": "232.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult patients (18-80 years) who are undergoing colonoscopy for screening or surveillance purposes. \n\n ", - "exclusion_criteria": ": \n\n Patients with a prior history of colonic surgeries \n\n Patient with Crohns colitis or ulcerative colitis \n\n Patient with prior history of colon cancer \n\n Patient with poor bowel preparation \n\n Pregnant women", - "brief_summary": "Colonoscopy( examining the colon with a flexible tube and a camera ) is usually done for screening purposes to find any precancerous lesions (polyps) at an early stage. During the colonoscopy the doctor will advance the colonoscope to the end of your colon and start examining the colon for any polyps. Withdrawal time is the period of time the doctor spends examining the colon. Doctors usually spend six minutes examining the colon after they reach the end of the colon. Studies have showed that spending more withdrawal time detects more lesions. The proposal to dedicating half of the withdrawal time during colonoscopy in examining the right side will increase the detection of polyps in the right side of the colon. There will be no other changes in the procedural aspect of the colonoscopy.", - "NCTID": "NCT02538406" - }, - { - "brief_title": "The Chemopreventive Effect of Metformin in Patients With Familial Adenomatous Polyposis: Double Blinded Randomized Controlled Study", - "phase": "Phase 2", - "drugs": "['Metformin', 'Metformin', 'Placebo']", - "drugs_list": [ - "Metformin", - "Metformin", - "Placebo" - ], - "diseases": "['Familial Adenomatous Polyposis']", - "diseases_list": [ - "Familial Adenomatous Polyposis" - ], - "enrollment": "34.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with familial adenomatous polyposis(FAP) who are 20 to 65 years of age. \n\n FAP patients who have colonic or duodenal polyp \n\n FAP patients who have five or more polyps 2mm or more in diameter in endoscopic examination. \n\n ", - "exclusion_criteria": ": \n\n FAP patients who had a history of colectomy within the previous 12 months or need to undergo colectomy within 8 months after randomization. \n\n FAP patients with malignant disease, including colorectal cancer. \n\n FAP patients who used NSAIDs (non-steroidal anti-inflammatory drugs) or aspirin three or more times a week within 6 months of randomization. 4. FAP patients with diabetes mellitus. 5. Pregnant or breast-feeding patients. 6. Patients with abnormal results of serum laboratory tests (renal function and liver function test) and significant infectious or respiratory diseases.", - "brief_summary": "Familial adenomatous polyposis (FAP) leads to adenomas and eventual adenocarcinomas in colon and less frequently, duodenum. Chemopreventive strategies have been studied in FAP patients to delay the development of adenomas and cancers. The non-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase-2 inhibitor have shown the regression of colorectal and duodenal adenomas in FAP patients. However, these drugs showed gastrointestinal damage and cardiovascular risks, and new preventive strategies are needed. Metformin, a biguanide, which is widely used for treating diabetes mellitus, has recently been suggested to have a suppressive effect on tumorigenesis via mTOR-inhibiting pathway, and have no significant safety issues in long term use. The investigators devised a double-blind randomized controlled trial to evaluate the effect of metformin on polyps of colorectum and duodenum in non-diabetic FAP patients.", - "NCTID": "NCT01725490" - }, - { - "brief_title": "A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP) (0966-205)(TERMINATED)", - "phase": "Phase 4", - "drugs": "['MK0966; rofecoxib / Duration of Treatment: 24 weeks', 'Comparator: placebo / Duration of Treatment: 24 weeks']", - "drugs_list": [ - "MK0966; rofecoxib / Duration of Treatment: 24 weeks", - "Comparator: placebo / Duration of Treatment: 24 weeks" - ], - "diseases": "['Adenomatous Polyposis Coli']", - "diseases_list": [ - "Adenomatous Polyposis Coli" - ], - "enrollment": "62.0", - "inclusion_criteria": "inclusion criteria: \n\n Males or females at least 18 years of age with familial adenomatous polyposis.", - "exclusion_criteria": "", - "brief_summary": "A study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in patients with Familial Adenomatous Polyposis.", - "NCTID": "NCT00140894" - }, - { - "brief_title": "Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)", - "phase": "Phase 3", - "drugs": "['Eflornithine', 'Eflornithine Placebo', 'Sulindac 150 MG', 'Sulindac placebo']", - "drugs_list": [ - "Eflornithine", - "Eflornithine Placebo", - "Sulindac 150 MG", - "Sulindac placebo" - ], - "diseases": "['Familial Adenomatous Polyposis']", - "diseases_list": [ - "Familial Adenomatous Polyposis" - ], - "enrollment": "171.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of phenotypic classical FAP with disease involvement of the duodenum and/or colon/rectum/pouch. \n\n Genotype: Adenomatous polyposis coli (APC) mutation (with or without family history) required \n\n Classical FAP Phenotype: 100's to 1,000's of colorectal adenomatous polyps, usually appearing in teenage years \n\n Upper gastrointestinal (UGI) endoscopy/ lower gastrointestinal (LGI) endoscopy (proctoscopy/colonoscopy) performed within 30 days of randomization. \n\n Patients with an intact colon/rectum, except for clinical polyposis, and prophylactic surgery is being considered as a stratification site. \n\n Rectal/pouch polyposis as a stratification site as follows: \n\n At least three years since colectomy with ileorectal anastamosis (IRA)/proctocolectomy with pouch, and demonstrating polyposis as defined by Stage 1, 2, 3, of the proposed InSiGHT 2011 Staging System (Appendix B) and summarized as follows: \n\n Stage 1: 10-25 polyps, all < 5 mm Stage 2: 10-25 polyps, at least one > 1 cm Stage 3: >25 polyps amenable to complete removal, or any incompletely removed sessile polyp, or any evidence of high grade dysplasia, even if completely removed. [Note: For staging purposes only.] \n\n For all subjects, any rectal/pouch polyps > 5 mm must be excised at baseline. \n\n Duodenal polyposis as a stratification site; one or more of the following: \n\n Current Spigelman Stage 3 or 4. \n\n Prior surgical endoscopic intervention within the past six months for Spigelman Stage 3 or 4 that may have been down staged to Spigelman Stage 1 or 2. \n\n Hematopoietic Status (within 30 days prior to randomization): \n\n No significant hematologic abnormalities \n\n White blood cell count (WBC) at least 3,000/mm3 \n\n Platelet count at least 100,000/mm3 \n\n Hemoglobin at least 10.0 g/dL \n\n No history of clinical coagulopathy \n\n Hepatic Status (within 30 days prior to randomization): \n\n Bilirubin no greater than 1.5 times ULN \n\n Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) no greater than 1.5 times ULN \n\n Alkaline phosphatase no greater than 1.5 times ULN \n\n Renal Status (within 30 days prior to randomization): \n\n a) Creatinine no greater than 1.5 times ULN \n\n Hearing: \n\n a) No clinically significant hearing loss, defined in Section 6.2, number 9. \n\n If female, neither pregnant nor lactating. \n\n Negative pregnancy test if female of child-bearing potential. Fertile patients must use effective contraception*. \n\n Absence of gross blood in stool; red blood on toilet paper only acceptable. \n\n No discrete gastric or duodenal ulcer greater than 5 mm within the past year except Helicobacter pylori-related peptic ulcer disease treated with antibiotics. \n\n No invasive malignancy within the past 5 years except resected non-melanomatous skin cancer, papillary thyroid cancer, or precancerous cervical dysplasia. \n\n No other significant medical or psychiatric problems that would preclude study participation or interfere with capacity to give informed consent. \n\n Use of 81-100 mg daily aspirin or up to 700 mg aspirin not more than once a week are eligible. \n\n No concurrent warfarin, fluconazole, lithium, Pradaxa\u00ae or other direct thrombin inhibitors, Plavix\u00ae, cyclosporine, other NSAIDs (such as ibuprofen, aspirin, diflunisal), diuretics (furosemide and thiazides), dimethylsulfoxide (DMSO), methotrexate, probenecid, propoxyphene hydrochloride, Tylenol\u00ae (acetaminophen) preparations containing aspirin or cytotoxic chemotherapy drugs. \n\n Willingness to forego concurrent use of supplements containing omega-3 fatty acids, corticosteroids, non-steroidal anti-inflammatory drugs or other FAP directed drug therapy. \n\n Able to provide informed consent and follow protocol requirements. \n\n ", - "exclusion_criteria": ": \n\n Prior pelvic irradiation. \n\n Patients receiving oral corticosteroids within 30 days of enrollment. \n\n Treatment with other investigational agents in the prior 4 weeks. \n\n Use of other non-steroidal anti-inflammatory drugs (such as ibuprofen) exceeding 4 days per month, in the prior 6 weeks. \n\n Regular use of aspirin in excess of 700 mg per week. \n\n Treatment with other FAP directed drug therapy (including sulindac or celecoxib, fish oil) within 12 weeks of study enrollment. \n\n Hypersensitivity to cyclooxygenase-2 inhibitors, sulfonamides, NSAIDs, or salicylates; NSAID associated symptoms of gastritis. \n\n Patients must not have cardiovascular disease risk factors as defined below: \n\n Uncontrolled high blood pressure (systolic blood pressure > 150 mm Hg \n\n Unstable angina \n\n History of documented myocardial infarction or cerebrovascular accident \n\n New York Heart Association Class III or IV heart failure \n\n Known uncontrolled hyperlipidemia defined as LDL-C >= 190 mg/dL or triglycerides >= 500 mg/dL \n\n Patients with significant hearing loss are not eligible for study participation defined as hearing loss that affects everyday life and/or for which a hearing aid is required. \n\n Colon/rectum/pouch with high grade dysplasia or cancer on biopsy or a large polyp (>1 cm) not amenable to complete removal. \n\n Duodenal cancer on biopsy. \n\n Intra-abdominal desmoid disease, stage III or IV \n\n Inability to provide informed consent.", - "brief_summary": "The purpose of this randomized, double-blind, Phase III trial is to determine if the combination of eflornithine plus sulindac is superior to sulindac or eflornithine as single agents in delaying time to the first occurrence of any FAP-related event. This includes: 1) FAP related disease progression indicating the need for excisional intervention involving the colon, rectum, pouch, duodenum and/or 2) clinically important events which includes progression to more advanced duodenal polyposis, cancer or death.", - "NCTID": "NCT01483144" - }, - { - "brief_title": "A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients", - "phase": "Phase 2", - "drugs": "['Erlotinib', 'Sulindac', 'Placebo A', 'Placebo B']", - "drugs_list": [ - "Erlotinib", - "Sulindac", - "Placebo A", - "Placebo B" - ], - "diseases": "['Adenomatous Polyposis Coli']", - "diseases_list": [ - "Adenomatous Polyposis Coli" - ], - "enrollment": "92.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who are 18 years or older with a clinical or genetic diagnosis of FAP or attenuated FAP. \n\n Presence of duodenal polyps with a sum of diameters \u2265 5mm. \n\n Minimum of two weeks since any major surgery \n\n WHO performance status \u22641 \n\n Adequate bone marrow function as show by: normal leukocyte count, platelet count \u2265 120 x 109/L, Hgb > 12 g/dL \n\n Adequate liver function as shown by: normal serum bilirubin(\u2264 1.5 Upper Limit Normal {ULN}) and serum transaminases (\u2264 2.0 ULN) \n\n Patient must discontinue taking any Nonsteroidal anti-inflammatory drugs (NSAIDS) within one month of treatment initiation. \n\n Patients must be able to provide written informed consent. \n\n ", - "exclusion_criteria": ": \n\n Prior treatment with any investigational drug within the preceding 4 weeks. \n\n Malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skins. \n\n Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study as determined by the Principal Investigator such as: \n\n Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction \u2264 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia \n\n Severely impaired lung function \n\n Any active (acute or chronic) or uncontrolled infection/ disorders. \n\n Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy \n\n Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis \n\n Screening clinical laboratory values that indicate any of the following: \n\n anemia \n\n thrombocytopenia \n\n leucopenia \n\n elevations of transaminases greater than 2X ULN \n\n elevation of bilirubin > 1.5 X ULN \n\n alkaline phosphatase elevation > 1.5 X ULN \n\n increased creatinine, urinary protein, or urinary casts outside the clinically normal range. \n\n Gastrointestinal bleeding (symptoms including dyspnea, fatigue, angina, weakness, malaise, melena, hematochezia, hematemesis, anemia or abdominal pain will require clinical assessment to rule out gastrointestinal bleeding). \n\n Patient who is currently taking any anti-coagulation medication. \n\n Women who are pregnant or breast feeding. \n\n Patients with a known hypersensitivity to sulindac or erlotinib or to their excipients", - "brief_summary": "The purpose of this study is to determine in a randomized, placebo-controlled, phase II trial if the combination of sulindac and erlotinib causes a significant regression of duodenal and colorectal adenomas in familial adenomatous polyposis (FAP) and attenuated FAP (AFAP) patients.", - "NCTID": "NCT01187901" - }, - { - "brief_title": "Effect of a Tracking Program on Colon Adenoma Surveillance and Adherence to Guideline Recommendations", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Colon Polyp Surveillance']", - "diseases_list": [ - "Colon Polyp Surveillance" - ], - "enrollment": "500.0", - "inclusion_criteria": "inclusion criteria: \n\n Any adenoma found on screening/surveillance colonoscopy (ICD9-211.3, Procedure code 45385 or 45380) \n\n Greater than 18 years old \n\n ", - "exclusion_criteria": ": \n\n Less than 18 years old \n\n Diagnosis of IBD", - "brief_summary": "This will be a retrospective chart review of 880-1000 patients who had a colonoscopy and were found to have a tubular adenoma between the years of 2004-2008. We will compare the rate and timing of completion of repeat colonoscopies pre and post establishment of a polyp registry (tracking system) in 2006. Each group will be composed of up to 500 subjects consecutively identified from all the patients who underwent colonoscopy and were found to have a tubular adenoma (Group 1-2004 to 2006, Group 2 2007-2008).", - "NCTID": "NCT01713881" - }, - { - "brief_title": "Autonomic Profiles in Pediatric Patients With Cyclic Vomiting Syndrome (CVS), Irritable Bowel Syndrome (IBS),Postural Orthostatic Tachycardia Syndrome (POTS), Functional Abdominal Pain (FAP) or Chronic Nausea", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Vomiting Syndrome', 'Irritable Bowel Syndrome', 'Postural Orthostatic Tachycardia Syndrome', 'Abdominal Pain', 'Chronic Nausea']", - "diseases_list": [ - "Vomiting Syndrome", - "Irritable Bowel Syndrome", - "Postural Orthostatic Tachycardia Syndrome", - "Abdominal Pain", - "Chronic Nausea" - ], - "enrollment": "19.0", - "inclusion_criteria": "inclusion criteria: \n\n Outpatient services \n\n ", - "exclusion_criteria": ": \n\n Inpatient services", - "brief_summary": "Retrospectively review the charts of all children who had heart rate variability, deep breathing test, valsalva maneuver, tilt table test, thermoregulatory sweat testing, quantitative sudomotor axon reflex test (QSART) completed and were cared for at Children's Hospital of Wisconsin.", - "NCTID": "NCT00728026" - } - ] - }, - { - "patient_id": "sigir-201429", - "patient": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", - "0": [ - { - "brief_title": "Osteoporosis School", - "phase": "", - "drugs": "['Intensive systematic information (osteoporosis school)']", - "drugs_list": [ - "Intensive systematic information (osteoporosis school)" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "350.0", - "inclusion_criteria": "inclusion criteria: \n\n fracture caused by osteoporosis \n\n fifty years or more of age \n\n informed consent \n\n ", - "exclusion_criteria": ": \n\n - Physically or mental state that does not participation", - "brief_summary": "The purpose of this study is to investigate the efficacy of systematic education (osteoporosis school) on fall frequency, compliance and quality of life of a group of patients more than fifty years of age.~Hypothetically, systematic information can increase compliance to the medical treatment, decrease the frequency of falls and increase the quality of life.", - "NCTID": "NCT00224991" - }, - { - "brief_title": "Adherence to Osteoporosis Treatment and Physicians' Perception Regarding Osteoporosis Medication", - "phase": "", - "drugs": "['Teriparatide']", - "drugs_list": [ - "Teriparatide" - ], - "diseases": "['Osteoporosis, Postmenopausal', 'Osteoporosis, Steroid Induced']", - "diseases_list": [ - "Osteoporosis", - "Postmenopausal", - "Osteoporosis", - "Steroid Induced" - ], - "enrollment": "851.0", - "inclusion_criteria": "inclusion criteria: \n\n Female patients with postmenopausal osteoporosis (T-score \u2264-2,5 SD at any skeletal site) under osteoporosis treatment (except teriparatide) for at least one year with a history of \u2265 low-energy fracture during the last 10 years prior the study. \n\n Male patients \u2265 50 years old with idiopathic osteoporosis (T-score \u2264-2,5 SD at any skeletal site) under osteoporosis treatment (except teriparatide) for at least one year with a history of \u2265 low-energy fracture during the last 10 years prior the study. \n\n Male and female patients with steroid-induced osteoporosis (T-score \u2264-2,5 SD at any skeletal site) under osteoporosis treatment (except teriparatide) for at least one year with a history of \u2265 low-energy fracture during the last 10 years prior the study. \n\n ", - "exclusion_criteria": ": \n\n Prior use of teriparatide or PTH(1-84) \n\n Hypersensitivity to teriparatide regimen. \n\n Pregnancy and lactation. \n\n Hypercalcamia. \n\n Renal deficiency (eGFR < 30 ml/min). \n\n Other bone metabolic diseases (including hyperparathyroidism and Paget's disease) except primary osteoporosis or steroid induced osteoporosis . \n\n Uninterpretable increases of alkaline phosphatase (ALP) \n\n Prior skeletal radiotherapy. \n\n Skeletal malignancies or bone metastases", - "brief_summary": "This is a study aiming to investigate a possible correlation between the parameters affecting the physicians' therapeutic choice with the patients' overall adherence to osteoporosis treatment. Secondary end-points include correlation between the parameters affecting the physicians' therapeutic choice and the patients' quality of life as well as the evaluation of the whole osteoporosis treatment approach of orthopedic surgeons in Greece (diagnostic means, use of diagnostic and treatment guidelines, methodology of follow - up).", - "NCTID": "NCT02472782" - }, - { - "brief_title": "Improved Screening for Osteoporosis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "3226.0", - "inclusion_criteria": "inclusion criteria: \n\n Women between 50 and 80 years \n\n Hospitalized \n\n In health services, orthopedics, gynecology, surgery \n\n Able to respond to an easy questionnaire \n\n Able to give their agreement to participate in the study \n\n ", - "exclusion_criteria": ": \n\n Patients with dementia \n\n Patients can not express \n\n Patients at end of life \n\n Patients previously treated for osteoporosis or recent densitometry (BMD) <3 years \n\n Patients could not be seen in time by the nurse during their hospitalization \n\n Patients receiving a measure of legal protection", - "brief_summary": "Osteoporosis is a disease characterized by skeletal fragility due to decreased bone mass and deterioration of bone microarchitecture , leading to increased fracture risk for low trauma, such as spinal fractures or femoral neck .~It is estimated that 3 million people are living in France , particularly women , with an incidence that increases with age .~This disease is a major public health issue in terms of morbidity and mortality , costs and risk of recurrence (after a first fracture episode) , including risk factors are identified.~However, although bone densitometry is a reliable diagnostic tool and preventive treatments are at our disposal, screening for osteoporosis is still insufficient .~The objective of our study is to improve the detection of osteoporosis in Hospital Departmental Vendee , using a simple questionnaire seeking risk factors followed by bone densitometry or if risk factors are found. Based on the results , the patient will be sent in rheumatology consultation for implementation of treatment if necessary .~Therefore included women hospitalized in medical services , gynecology, surgery and orthopedics Hospital Departmental Vendee , aged 50 to 80 years. Will not be included women who could answer a simple questionnaire and those previously treated for osteoporosis or have already received a bone density there is less than 3 years old .", - "NCTID": "NCT02066480" - }, - { - "brief_title": "Osteoporosis and Fall Prevention Education", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "127.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults between the ages of 40 to 90. \n\n Adults who been fractures prior to assessment. \n\n Adults who have ability, well conscious to complete the questionnaires. \n\n ", - "exclusion_criteria": ": \n\n 1.Adults who have treatment currently will not include in this study.", - "brief_summary": "Objective: The study is to increasing osteoporosis awareness with fracture risk assessments and management as well as fall prevention among elderly in northern region of Taiwan.~Method: Six community osteoporosis and fall prevention educational programme will be held at northern region of Taiwan. A questionnaires design including demographic variables , FRAX variables, nutritional variables and osteoporosis and fall knowledge variables as well.The pretest-posttest method was used to analyse the effect on education.~Expected outcomes : (1)Fall prevention educational programme will hold in northern region of Taiwan at different communities in order to increasing osteoporosis awareness with fracture risk assessment tool, establishing fall knowledges among elderly and some fall prevention skills.(2)Elderly with 10-year probability of major osteoporotic fracture risk who more than 20% and 10-year probability of hip fracture risk who more than 3% will identify as high risk of osteoporosis. (3) To estimate number of cases who identified as high risk will recommend for BMD measurement.", - "NCTID": "NCT01934400" - }, - { - "brief_title": "Secondary Prevention of Osteoporotic Fractures in Residents of Long-Term Care Facilities", - "phase": "Phase 2; Phase 3", - "drugs": "['Long-term care facilities in the intervention arm will receive education and feedback audit on performance']", - "drugs_list": [ - "Long-term care facilities in the intervention arm will receive education and feedback audit on performance" - ], - "diseases": "['Hip Fractures', 'Osteoporosis']", - "diseases_list": [ - "Hip Fractures", - "Osteoporosis" - ], - "enrollment": "64.0", - "inclusion_criteria": "inclusion criteria: \n\n Any North Carolina long-term care facility with ten residents who had had a hip fracture or osteoporosis diagnosis", - "exclusion_criteria": "", - "brief_summary": "Osteoporotic fractures of the hip are a major cause of admission to long-term care facilities. Such fractures put patients at high risk for further fractures, pain and disability. Current data show that many patients in long-term care facilities do not receive FDA medications for their osteoporosis. This trial will test whether a multi-model intervention (which provides feedback about provider use of osteoporosis medications, information about osteoporosis, and currently approved osteoporosis medications)directed at physicians, other health care providers, and nurses will improve the number of prescriptions written for FDA approved medications for osteoporosis treatment.", - "NCTID": "NCT00280943" - }, - { - "brief_title": "Falls Prevention in Osteoporosis", - "phase": "", - "drugs": "['Falls Prevention Program']", - "drugs_list": [ - "Falls Prevention Program" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "96.0", - "inclusion_criteria": "inclusion criteria: \n\n osteoporosis (DXA T-score < -2.5 in hip and/or vertebrae) \n\n able to walk at least 15 minutes without an helping device \n\n 65 years or older \n\n community dwelling \n\n at least one fall in the prior year \n\n ", - "exclusion_criteria": ": \n\n severe cardiac, pulmonary or musculoskeletal disorders \n\n pathologies associated with increased fall risks (i.e. stroke or Parkinson's disease) \n\n use of psychotropic drugs", - "brief_summary": "The purpose of this study is to determine wether a falls prevention program can reduce fall incidence in people with osteoporosis.", - "NCTID": "NCT00432692" - }, - { - "brief_title": "A Study of Prevention and Treatment of Postmenopausal Osteoporosis in Chinese Women", - "phase": "Phase 4", - "drugs": "['Placebo', 'estradiol valerate']", - "drugs_list": [ - "Placebo", - "estradiol valerate" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "221.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients meet the criteria: \n\n Patients with informed consent. \n\n Breast Cancer inform possible danger. \n\n Physical and mental health. \n\n Menopausal transition meet the criteria: \n\n Age between 40 \n\n 55 years old. \n\n Women with Menopause syndrome or menstrual disorders. \n\n The second to fourth lumbar spine bone mineral density to normal. \n\n Early postmenopause meet the criteria: \n\n Age between 45 \n\n 60 years old. \n\n Spontaneous amenorrhea for more than six months and less than 5 years. \n\n The second to fourth lumbar spine bone mineral density was between -1 and -2.5 Standard deviation Compared with normal young women. \n\n ", - "exclusion_criteria": ": \n\n Tobacco or alcohol abuser. \n\n History of various malignant diseases. \n\n Women with Serious chronic diseases, such as liver and kidney dysfunction. \n\n Women Suffering from endocrine diseases, such as Thyroid disease, Parathyroid disease,Adrenal disease and Osteomalacia. \n\n Women with Long-term application of drugs, such as Antiepileptic drug, Adrenocorticotropic hormone, Diuretics and Heparin. \n\n Women had used estrogen or calcitonin in the past 6 months. \n\n Women has added higher than the physiological requirements VitD. \n\n Who had taken bisphosphonates or sodium fluoride in the past 1 year. \n\n Women had been taking Chinese medicines or other unregistered food in past 3 months. \n\n Women with one of the following medical history or disease: Thrombophlebitis, estrogen-related thrombosis or thromboembolism, Cerebrovascular accident, with known or suspected estrogen-dependent tumor, undiagnosed vaginal bleeding, Cervical Pap smear graded at 3 or more, Serious uterine disorders, Serious breast disorders, Serious gallbladder disease, Severe hypertension and Hypercholesterolemia \n\n Secondary osteoporosis. \n\n Participants' lumbar spine anatomy(at least L1 \n\n L4) is not suitable to do dual-energy X-ray absorptiometry measured, such as obvious scoliosis, bone injury and Orthopedic surgery Sequelae. \n\n Doctor consider inappropriate to participate in because of other diseases.", - "brief_summary": "The purpose of this trial is to study the efficacy and safety of low dose of estradiol valerate in the prevention and treatment of postmenopausal osteoporosis.", - "NCTID": "NCT00860964" - }, - { - "brief_title": "Teriparatide Treatment in Patients With Inherited Osteoporosis", - "phase": "Phase 4", - "drugs": "['Teriparatide']", - "drugs_list": [ - "Teriparatide" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "6.0", - "inclusion_criteria": "inclusion criteria: \n\n inherited low-turnover osteoporosis \n\n lumbar spine or hip BMD T-score \u2264 -2.5 \n\n a written informed consent. \n\n ", - "exclusion_criteria": ": \n\n age less than 18 years \n\n generally accepted contraindications for the treatment", - "brief_summary": "The purpose of this study is to analyse efficacy of teriparatide treatment in patients with new forms of inherited low-turnover osteoporosis.", - "NCTID": "NCT01360424" - }, - { - "brief_title": "Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia\u00ae in France", - "phase": "", - "drugs": "['AMG 162 - Prolia', 'AMG 162 - Prolia']", - "drugs_list": [ - "AMG 162 - Prolia", - "AMG 162 - Prolia" - ], - "diseases": "['Post Menopausal Osteoporosis']", - "diseases_list": [ - "Post Menopausal Osteoporosis" - ], - "enrollment": "777.0", - "inclusion_criteria": "inclusion criteria: \n\n post menopausal osteoporosis women in whom a decision has been made to treat with Prolia in the last 4 weeks \n\n received their first prescription of Prolia in the last 4 weeks \n\n patient has provided informed consent before enrolling in the study \n\n ", - "exclusion_criteria": ": \n\n patients participating in ongoing or previous Denosumab clinical trials", - "brief_summary": "The purpose of the study is to describe the characteristics and management of post menopausal women with osteoporosis treated with Prolia in France, and examine the use of Prolia in routine clinical practice in France", - "NCTID": "NCT02347865" - }, - { - "brief_title": "Quality of Life(QoL) in Korean Postmenopausal Osteoporosis Patients With Bisphosphonate Treatment", - "phase": "", - "drugs": "['OPSAT-Q']", - "drugs_list": [ - "OPSAT-Q" - ], - "diseases": "['Osteoporosis, Postmenopausal']", - "diseases_list": [ - "Osteoporosis", - "Postmenopausal" - ], - "enrollment": "4376.0", - "inclusion_criteria": "inclusion criteria: \n\n Who have been diagnosed with postmenopausal osteoporosis by physician Who have received any oral bisphosphonates (weekly or monthly) at least for 2 months to provide answer of OPSAT-QTM questionnaire Who provide informed consent for study participation \n\n ", - "exclusion_criteria": ": \n\n Do not understand the contents of the questionnaire", - "brief_summary": "Quality of Life (QoL) in Korean postmenopausal osteoporosis patients with bisphosphonate treatment", - "NCTID": "NCT01227369" - }, - { - "brief_title": "HRT Versus Etidronate for Osteoporosis and Fractures in Asthmatics Receiving Glucocorticoids.", - "phase": "Phase 4", - "drugs": "['Hormone Replacement Therapy and Etidronate']", - "drugs_list": [ - "Hormone Replacement Therapy and Etidronate" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "750.0", - "inclusion_criteria": "inclusion criteria: \n\n Postmenopausal, asthmatic outpatients under 60 years of age on long-term oral or inhaled glucocorticoid treatment for at least one year. \n\n ", - "exclusion_criteria": ": \n\n Hysterectomy, history of breast or endometrial cancer, undiagnosed pelvic or breast mass, untreated hypertension.", - "brief_summary": "To determine and compare the effects of Hormone replacement therapy (HRT), etidronate, HRT plus etidronate and no treatment over 5 years in the prevention and treatment of glucocorticoid-induced osteoporosis and fractures in post-menopausal women with asthma.", - "NCTID": "NCT00376662" - }, - { - "brief_title": "Education for Osteoporosis in Persons With Existing Fractures", - "phase": "", - "drugs": "['Osteoporosis Prevention and Self-Management Course', 'Introductory education session on osteoporosis']", - "drugs_list": [ - "Osteoporosis Prevention and Self-Management Course", - "Introductory education session on osteoporosis" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "152.0", - "inclusion_criteria": "inclusion criteria: \n\n Presented to Modbury Hospital's Accident and Emergency Department with a new bone fracture \n\n ", - "exclusion_criteria": ": \n\n Residence in nursing home \n\n Fracture sustained in motor bike, push bike or motor vehicle accident \n\n Fracture sustained due to high trauma, such as fall from roof or ladder \n\n Dementia \n\n Inability to participate in group settings \n\n Inability to understand spoken English \n\n Inability to provide informed consent \n\n Pathological fracture \n\n Usual place of residence outside South Australia", - "brief_summary": "We wish to investigate whether a weekly, 2\u00bd hour group-based osteoporosis education intervention (the Osteoporosis Prevention and Self-Management Course), is different to one session course (1x 2\u00bd hours) on osteoporosis knowledge, confidence to eat calcium-containing foods, confidence to exercise, and amount of exercise undertaken after three and nine months of follow-up in people aged over 50 years who have already had a bone fracture.", - "NCTID": "NCT00575250" - }, - { - "brief_title": "The Effectiveness of Individualised Bone Density Feedback and Osteoporosis Education in Premenopausal Women", - "phase": "Phase 2", - "drugs": "['individualised bone density feedback and education']", - "drugs_list": [ - "individualised bone density feedback and education" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "400.0", - "inclusion_criteria": "inclusion criteria: \n\n women aged between 25 and 44 years of age \n\n ", - "exclusion_criteria": ": \n\n previous had measurement of bone densitometry \n\n thyroid disease \n\n renal failure \n\n malignancy \n\n rheumatoid arthritis \n\n history of hysterectomy \n\n hormone replacement therapy \n\n were pregnant or planning pregnancy within 2 years of study entry \n\n lactating.", - "brief_summary": "The purpose of this study is to determine whether giving women feedback concerning their bone mineral density, combined with either an information leaflet or group education concerning osteoporosis changes women's behavior and/or bone density.", - "NCTID": "NCT00273260" - }, - { - "brief_title": "Treatment of Childhood Osteoporosis With Alendronate (Fosamax)", - "phase": "Phase 2", - "drugs": "['Alendronate']", - "drugs_list": [ - "Alendronate" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Chronological age: 6.0 - 17.0 years. Study population will be restricted to children greater than 12 years of age until 8 patients have completed 6 months of the study or safety data is available from a comparable study. \n\n AP Lumbar spine bone mineral density less than or equal to -2 standard deviations for age matched controls (z-score) using Hologic QDR machine. \n\n Normative data published by Faulkner will be used to calculate Z-scores. \n\n Patients with Idiopathic Juvenile Osteoporosis, osteoporosis (BMD less than -2 SD compared to age-matched controls) in a child with no identifiable etiology. Children with IJO and delayed puberty will have their z-score calculated on the basis of bone age. \n\n ", - "exclusion_criteria": ": \n\n Inability to swallow pills or comply with administration instructions. \n\n Upper gastrointestinal tract disease. \n\n Creatinine clearance greater than or equal to 35 mL per min per 1.73 square meters. \n\n Prior treatment with bisphosphonates. \n\n Concurrent therapy with oral aspirin or salicylate containing compounds, excluding delayed-release salicylates which act in the distal gastrointestinal tract (for example, mesalamine, sulfasalazine, etc...). \n\n Hypocalcemia. \n\n Treatment with hGH or calcitonin in the preceding 6 months. \n\n Inability to undergo dual energy x-ray absorptiometry. \n\n Positive pregnancy test. \n\n In females, sexual activity without an effective method of contraception.", - "brief_summary": "Bones grow and stay strong through a continuous process of formation (building) and resorption (break down). When more bone is formed than resorbed, the density (level of calcium) in bone increases and the bones become stronger. However, if more bone is resorbed than formed the density of bone decreases and the bones become weak. This condition is called osteoporosis.~Osteoporosis is a rare but serious condition in children. Childhood osteoporosis can occur without a known cause (idiopathic juvenile osteoporosis). Children with osteoporosis suffer from pain, inability to stay active, and increased amounts of broken bones, including fractures of the spine. Even mild childhood osteoporosis may have long-term consequences since individuals who achieve a less than normal bone composition (peak bone mass) during the first 20-30 years of life may be at an increased risk for osteoporosis as adults.~Alendronate (Fosamax) is a drug that works by stopping bone resorption (break down). It has been used to treat post-menopausal osteoporosis, male osteoporosis and adults with osteoporosis due to long-term steroid therapy. The goal of this study is to determine the effectiveness of alendronate in children with idiopathic juvenile osteoporosis. Researchers believe that children treated with alendronate will improve bone strength and decrease the amount of fractures caused by osteoporosis.", - "NCTID": "NCT00001720" - }, - { - "brief_title": "Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday", - "phase": "", - "drugs": "['Questionnaires about compliance and persistence with bisphosphonates treatment']", - "drugs_list": [ - "Questionnaires about compliance and persistence with bisphosphonates treatment" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Postmenopausal women \n\n Diagnosis of osteoporosis in the medical record \n\n At least one prescription drug to treat osteoporosis in the last 5 years \n\n Insured by Clalit Health Services \n\n Hebrew-speaking capability and readiness to answer a questionnaire \n\n ", - "exclusion_criteria": ": \n\n Premenopausal women \n\n No diagnosis of osteoporosis in the medical record \n\n No treatment for osteoporosis in the last 5 years \n\n Women who do not speak Hebrew or are unable to answer a questionnaire", - "brief_summary": "The purpose of the study is to provide information about the rate of response and persistence to drug therapies for osteoporosis. Another issue examined in this study refers to the preferences and concerns about future treatments in patients during drug holiday.", - "NCTID": "NCT01854086" - }, - { - "brief_title": "A Study to Assess the Disturbances in Calcitonin Gene in Patients With Gum Disease and Osteoporosis", - "phase": "", - "drugs": "['CTR Gene']", - "drugs_list": [ - "CTR Gene" - ], - "diseases": "['Osteoporosis', 'Generalized Chronic Periodontitis']", - "diseases_list": [ - "Osteoporosis", - "Generalized Chronic Periodontitis" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and Female \n\n Patients aged between 35.00 Year(s) to 60.00 Year(s) diagnosed with Osteoporosis and Chronic Periodontitis who are willing to participate in the study \n\n ", - "exclusion_criteria": ": \n\n Patients who are Systemically compromised and under medications such as steroids. \n\n Patients who smoke.Pregnant and lactating mothers are excluded from the study", - "brief_summary": "Osteoporosis and Periodontitis are multifactorial diseases which share common risk factors.The aim of the present study is to ellucidate polymorphisms in Calcitonin receptor gene? in patients with Osteoporosis and Periodontitis.", - "NCTID": "NCT02273128" - }, - { - "brief_title": "An Investigation Into Bone Micro-architecture in Women With Type 2 Diabetes", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Type 2 Diabetes Mellitus']", - "diseases_list": [ - "Type 2 Diabetes Mellitus" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n female \n\n >= 65 years old \n\n postmenopausal for > 5 years (WHO definition of menopause) \n\n ", - "exclusion_criteria": ": \n\n currently taking osteoporosis related medication (HRT, SERM, bisphosphonate, PTH, calcitonin, fluoride) \n\n had cancer in past 10 years, likely to metastasize to bone (ie: breast, lung) \n\n have intrinsic bone disease (ie: Paget's Disease, Cushings syndrome) \n\n have untreated malabsorption syndrome (ie: Celiac Disease) \n\n renal insufficiency (CrCl <30ml/min) \n\n hyperparathyroidism, hypoparathyroidism \n\n chronic systemic glucocorticosteroid use > 3mos, dose>2.5mg daily", - "brief_summary": "The number of people with type 2 diabetes is growing. This puts a lot of pressure on the health care systems. Type 2 diabetes is often associated with health problems, like poor eyesight, muscle coordination, muscle strength, and blood flow. Poor bone health may also be a concern for people with type 2 diabetes.~A large proportion of people with type 2 diabetes will break a bone in their lifetime. The risk of this happening in older people with type 2 diabetes is greater than the risk in older people without diabetes. Fracturing a bone can be very painful, and lead to serious consequences, especially if the individual experiences a hip fracture. The elevated fracture risk, seen in those with type 2 diabetes, is puzzling because people with type 2 diabetes often appear to have normal, healthy bones compared to people of the same age without diabetes.~Bone micro-structure, which is not assessed by traditional bone densitometry systems (ie: DXA) contributes to overall bone strength.~The hypothesis of this study is that bone micro-structure is of poorer quality (reduced trabecular thickness, increased trabecular spacing) in postmenopausal women with type 2 diabetes, compared to age-matched control participants.", - "NCTID": "NCT00982371" - }, - { - "brief_title": "Calcium and Bone Mass in Young Females", - "phase": "Phase 2", - "drugs": "['Calcium']", - "drugs_list": [ - "Calcium" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "354.0", - "inclusion_criteria": "inclusion criteria: \n\n Pubertal stage II \n\n Calcium intake below a threshold level \n\n Caucasian \n\n Normal health \n\n ", - "exclusion_criteria": ": \n\n Medications affecting calcium and bone metabolism \n\n Chronic diseases \n\n Metabolic bone disease \n\n Abnormality in calcium metabolism", - "brief_summary": "We originally suggested that calcium in the diet is important in determining the amount of bone (bone mass) that builds up in young adults. We are testing the effect of calcium on bone mass in 354 Caucasian (white) girls. At the start of this 7-year study, the average age of the girls was 11 years, and they had not yet reached puberty. The study will also provide information about the effect of calcium on body composition (body fat) and blood pressure in young women.~We have been giving calcium to one group of participants in this study and giving a placebo (an inactive pill, or sugar pill) to the other group. The results of this research will be important in preventing osteoporosis, because building more bone as a young person should reduce a woman's chances of developing osteoporosis later in life.", - "NCTID": "NCT00000402" - }, - { - "brief_title": "Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women", - "phase": "Phase 2", - "drugs": "['Teriparatide', 'Saline Placebo']", - "drugs_list": [ - "Teriparatide", - "Saline Placebo" - ], - "diseases": "['Adult Idiopathic Generalized Osteoporosis']", - "diseases_list": [ - "Adult Idiopathic Generalized Osteoporosis" - ], - "enrollment": "41.0", - "inclusion_criteria": "inclusion criteria: \n\n Premenopausal women, aged 20-45, with regular menses and no historical or biochemical secondary cause of osteoporosis. \n\n Documented adult fractures judged to be low-trauma. \n\n Must be willing to use effective contraception throughout the period of study drug administration. \n\n inclusion criteria - vary slightly based on age category: \n\n Premenopausal women ages 20-35 years must have at least one major osteoporotic fracture (excluding fractures of fingers, toes and face) and low Bone Mineral Density (BMD). \n\n Premenopausal women above the age of 35 years should have a history of fracture and/or low BMD. \n\n ", - "exclusion_criteria": ": \n\n History of any condition that increases the risk of osteosarcoma \n\n Early follicular phase serum \n\n Disorders of mineral metabolism \n\n Suspicion of osteomalacia \n\n Vitamin D deficiency \n\n Pregnancy or lactation within past 12 months \n\n Prolonged amenorrhea (> 6 months) during reproductive years (except pregnancy or lactation) \n\n Prior eating disorder \n\n Malignancy, except cured basal or squamous cell skin carcinoma \n\n Endocrinopathy: new onset untreated hyperthyroidism, hypothyroidism, Cushing's syndrome, prolactinoma \n\n Renal insufficiency \n\n Liver disease \n\n Intestinal disorders \n\n History/current glucocorticoids (GCs), anticonvulsants, anticoagulants, methotrexate, depot progesterone, Gonadotrophin-releasing hormone (GnRH) agonists \n\n Oral glucocorticoid use (subject will not be excluded if used dose equivalent to less than prednisone 5 mg for <3 months). \n\n Current anticoagulant use or low molecular weight \n\n Depo Provera use (subjects will not be excluded if used at age>20, >5 years ago) \n\n Drugs for osteoporosis (raloxifene, bisphosphonates, denosumab, calcitonin, TPTD). Subjects who discontinue these medications will be eligible 3 months after stopping raloxifene or calcitonin, 12 months after stopping alendronate, risedronate, ibandronate, or pamidronate and 18 months after stopping denosumab. Subjects with prior use of zoledronate may be eligible if received only one dose >4 years ago. Total bisphosphonate exposure must be < 1 year. Subjects who have taken TPTD in the past will not be eligible unless used for <3 months, > 2 years ago.", - "brief_summary": "Idiopathic osteoporosis (IOP) is defined as osteoporosis that affects young, otherwise completely healthy individuals with no secondary cause of bone loss. In the course of our prior research with premenopausal women with IOP, the investigators have shown that women with IOP have low areal bone mineral density (aBMD) at the spine, hip and forearm compared to normal women. Additionally, using noninvasive high resolution imaging of the central and peripheral skeleton and detailed analyses of transiliac crest bone biopsies, the investigators identified several features of bone quality in premenopausal women with IOP.~There is currently no FDA-approved therapy for IOP in premenopausal women. However, teriparatide (Forteo) has been shown to improve bone mass and microarchitecture in postmenopausal women and is approved for men with primary or idiopathic osteoporosis, as well as men, premenopausal and postmenopausal women with glucocorticoid-induced osteoporosis. Because IOP in premenopausal women is an orphan disease, with an estimated prevalence of about 113,000 in the United States, pharmaceutical companies are unlikely to support development of therapies for this indication. Therefore, the major objective of this protocol is to establish the safety and efficacy of teriparatide in premenopausal women with IOP in a phase 2 clinical trial. All subjects will receive teriparatide as part of the study, but a randomly selected group of patients (10) will receive one year of placebo injections first before starting their two years of treatment. The remainder of subjects (30) will receive active drug only for two years.~Funding Source - FDA OOPD", - "NCTID": "NCT01440803" - }, - { - "brief_title": "Determining the Risk Factors Such as Smoking, Alcohol, and Caffeine and Their Association With Osteoporosis in Men", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "1000.0", - "inclusion_criteria": "Veterans aged 50 and older drawn from two existing VA cohorts, the Normative Aging Study (NAS) and the Veterans Health Study (VHS).", - "exclusion_criteria": "", - "brief_summary": "The goals of this project are to establish a new cohort of male veterans and describe associations between potential risk factors and baseline bone mineral density (BMD) as well as rates of BMD loss.", - "NCTID": "NCT00011323" - }, - { - "brief_title": "Low-Dose Hormone Replacement Therapy and Alendronate for Osteoporosis", - "phase": "Phase 3", - "drugs": "['Alendronate', 'Estrogen/progestin therapy']", - "drugs_list": [ - "Alendronate", - "Estrogen/progestin therapy" - ], - "diseases": "['Osteopenia', 'Osteoporosis']", - "diseases_list": [ - "Osteopenia", - "Osteoporosis" - ], - "enrollment": "240.0", - "inclusion_criteria": "inclusion criteria: \n\n Women at least 60 years of age. \n\n Good general health. \n\n Willingness to participate in this 3.5 year study. \n\n Ability to give informed consent. \n\n Ability to live independently and travel to the research center for visits (we will provide transportation on a limited basis). \n\n Spine bone mineral density (BMD) (L1-4) T-score between -1.0 and -2.5, or a hip T-score between -1.0 and -2.5. A T-score of -1.0 is equal to a bone mass of one standard deviation below the mean peak bone mass in healthy young adult women. \n\n ", - "exclusion_criteria": ": \n\n Any history of cancer except the following: (a) superficial basal or squamous cell carcinoma of the skin which has been completely resected or resolved by a topical chemotherapeutic agent, and (b) other malignancies treated curatively at least 10 years previously, without any evidence of recurrence. \n\n Abnormal transvaginal ultrasound that has not been investigated and cleared by endometrial biopsy. \n\n History of low-trauma hip or spine fracture previously diagnosed. \n\n Serious residuals from cerebral vascular disease. \n\n Diabetes mellitus, except for easily controlled, non-insulin dependent or insulin dependent diabetes mellitus without significant microvascular or neuropathic disease. \n\n Serum creatinine >1.9 mg/dl. \n\n Chronic liver disease or alcoholism. \n\n Treatment with bone active agents such as fluoride or bisphosphonates within the previous 2 years. \n\n Treatment with calcitonin, estrogen, or a selective estrogen receptor modulator within the previous 6 months. \n\n Systemic corticosteroid therapy at pharmacologic levels for more than 6 months duration. \n\n Any corticosteroid therapy within the previous 6 months. \n\n Treatment with anticonvulsant therapy within the previous year. \n\n Clinically significant abnormalities on pre-study laboratory or clinical screens. \n\n Treatment with thyroid hormone is accepted, provided the patient is euthyroid at the time of entry, and the serum TSH by ultrasensitive assay is normal. \n\n Uncontrolled hypertension. \n\n Unstable angina. \n\n Myocardial infarction within 1 year prior to entry. \n\n Evidence of metabolic bone disease, e.g. hyper- or hypoparathyroidism, Paget's disease, osteomalacia, osteogenesis imperfecta, or others. \n\n Active rheumatoid arthritis or collagen disease. \n\n Recent major gastrointestinal disease (within the past year) such as peptic ulcer, malabsorption, chronic ulcerative colitis, regional enteritis, or any significant chronic diarrhea state. \n\n Tobacco use at a level of more than 10 cigarettes per day.", - "brief_summary": "Osteoporosis, a condition in which bones are fragile and break easily, is a major health problem for postmenopausal women. Research studies have shown that both estrogen/progestin replacement therapy (hormone replacement therapy, or HRT) and alendronate are effective in preventing and treating osteoporosis. However, because these drugs work in somewhat different ways, a combination of the two drugs might protect women from osteoporosis better than either drug alone. In this study we will test whether HRT and alendronate given together for 3.5 years to postmenopausal women with low bone mass will have a greater effect on bone than either HRT or alendronate given alone. We will also give every participant in this study calcium and vitamin D supplements.", - "NCTID": "NCT00000430" - }, - { - "brief_title": "Vitamin K as Additive Treatment in Osteoporosis", - "phase": "Phase 2; Phase 3", - "drugs": "['Phylloquinone', 'Menatetrenone (MK4)', 'placebo']", - "drugs_list": [ - "Phylloquinone", - "Menatetrenone (MK4)", - "placebo" - ], - "diseases": "['Post-menopausal Osteoporosis']", - "diseases_list": [ - "Post-menopausal Osteoporosis" - ], - "enrollment": "105.0", - "inclusion_criteria": "inclusion criteria: \n\n Inclusion in the cross-sectional part of the study which involves assessment of vitamin K status \n\n Informed consent to screening stage : assessment of vitamin K status \n\n serum vitamin K concentration < 0.35 ug/ml \n\n Inclusion into the randomised controlled trial \n\n 1. ambulatory post-menopausal women aged between 55-85 years 2. Post-menopausal osteoporosis ( history of previous fragility fractures or BMD evidence of osteoporosis or osteopenia with at least one clinical risk factors such as low BMI, positive family history of osteoporosis) 3. Treatment with a bisphosphonate and calcium/vitamin D supplements for at least 12 months 4. Informed written consent 5. e GFR >30 ml/min 6. normocalcaemia \n\n ", - "exclusion_criteria": ": \n\n Age <55 years, or > 85 years \n\n Male gender \n\n severe renal impairment (CKD stage 4 and 5) \n\n poor mobility (inability to walk 100 yards unaided) \n\n malabsorption (extensive bowel surgery, short bowel) \n\n generalised carcinomatosis \n\n glucocorticoid therapy \n\n inflammatory disorders (e.g. active rheumatoid arthritis, inflammatory bowel disease requiring oral glucocorticoids), \n\n endocrine diseases (e.g. primary hyperparathyroidism, hyperthyroidism). \n\n chronic liver disease \n\n current treatment with teriparatide, strontium ranelate \n\n Participation in a trial with an investigational product within the previous 3 months \n\n Serum vitamin K > 0.35 \u00b5g/ml \n\n patients on anti-coagulants such as warfarin", - "brief_summary": "Vitamin K is thought to be important for bone health because it activates several proteins involved in bone formation. Poor dietary intake of vitamin K (mainly found in dark green leafy vegetables) is associated with bone loss and fractures. Giving supplements of the main dietary form of vitamin K (called K1) or another common form which our bodies make from K1(called MK4), to improve bone health have given mixed results. This confusion is thought to have arisen because these studies involved people who already had enough vitamin K or did not have osteoporosis. We want to test the hypothesis that treatment with bisphosphonates combined with vitamin K, in vitamin K deplete elderly women with osteoporosis, may offer additional benefit on skeletal metabolism and reduction of fracture risk. We want to test this by measuring vitamin K status in post-menopausal women with osteoporosis who are on the recommended treatment with a bisphosphonate and calcium/vitamin D supplements. Those with low vitamin K will then be recruited to study the effect of supplementation with either K1 or MK4.", - "NCTID": "NCT01232647" - }, - { - "brief_title": "The Role of Vitamin D in Menopause: Relationship to Menopausal Symptoms in Body Composition", - "phase": "Phase 1", - "drugs": "['Vitamin D', 'Placebo']", - "drugs_list": [ - "Vitamin D", - "Placebo" - ], - "diseases": "['Menopause, Premature', 'Hot Flushes', 'Obesity', 'Vitamin D Deficiency']", - "diseases_list": [ - "Menopause", - "Premature", - "Hot Flushes", - "Obesity", - "Vitamin D Deficiency" - ], - "enrollment": "23.0", - "inclusion_criteria": "inclusion criteria: \n\n Women in late menopausal transition or early menopause \n\n Age 40-55 \n\n BMI >25 kg/m2 \n\n Suffer from menopausal symptoms \n\n Change in previously regular cycles consisting of at least \u22652 skipped cycles and an interval of amenorrhea (\u226560 days) in the last year \n\n Negative pregnancy test \n\n Vitamin D insufficiency (<30 ng/ml) \n\n Weight stability (+/- 5%) for 3 months \n\n ", - "exclusion_criteria": ": \n\n No period for >12 months \n\n Hormone use (i.e. menopausal hormone therapy, oral contraceptive, other hormonal medications) in last 3 months \n\n History of hysterectomy more than 11 months ago \n\n Abnormal screening blood tests (i.e. elevated serum calcium level, elevated creatinine) \n\n History of medical conditions where Vitamin D supplementation is not indicated (i.e. chronic renal insufficiency, elevated calcium, sarcoidosis or other granulomatous disease, lymphoma, or tuberculosis \n\n History of osteoporosis or osteoporosis on baseline DXA (expect less than 4% of screened population)84 \n\n Vitamin D deficiency (<10 ng/ml) as we felt it was unethical to withhold supplementation for 12 months in severe deficiency (according to our KPNW survey, this will exclude <2% of population) \n\n Consuming more than 400 IU of Vitamin D supplementation daily (we felt such doses taken outside of the study design could confound results) \n\n Current smoker (within the last year) \n\n Taking medications that affect body weight \n\n Prior bariatric surgery \n\n Taking medications or herbal supplements that affect mood (i.e. antidepressants) or menopausal symptoms (i.e. herbal meds) or sleep \n\n Weighing more than 400 pounds (cannot fit on DEXA scan) \n\n Not fluent in English or cognitively impaired", - "brief_summary": "Specific Aim 1: To compare effects of Vitamin D supplementation to usual care on symptoms in women transitioning to early postmenopause and determine the associated effect size in order to conduct a power analysis for a future RCT. Hypothesis: Vitamin D insufficient women in early postmenopause who are randomized to supplementation, titrated to achieve sufficiency for 2 months, will have fewer symptoms including hot flashes, mood, and musculoskeletal complaints than women randomized to usual care.~Specific Aim 2: To compare effects of Vitamin D supplementation to usual care on body composition (by dual-energy x-ray absorptiometry [DXA] and by weight, BMI, waist to hip ratio) in overweight/obese women transitioning to early postmenopause and determine the associated effect size for a power analysis for a future RCT. Hypothesis: Vitamin D insufficient women in the menopausal transition randomized to supplementation, titrated to achieve sufficiency for 9 months, will improve DXA body composition (less total body and abdominal fat), compared to women in usual care, who will have increased body weight, including total and abdominal fat.~Specific Aim 3: To estimate the proportion of overweight/obese middle-aged women who achieve sufficiency by 1 month versus 2 or more months and to determine if achieving sufficiency by 1 month varies by baseline characteristics. Hypothesis: About 80% of participants will achieve sufficient Vitamin D level by 1 month. Those who need more than 1 month for sufficiency will have lower baseline levels and higher initial BMI.", - "NCTID": "NCT01141972" - }, - { - "brief_title": "A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)", - "phase": "Phase 4", - "drugs": "['Placebo', 'Vitamin D and calcium supplementation', 'ibandronate [Bonviva/Boniva]']", - "drugs_list": [ - "Placebo", - "Vitamin D and calcium supplementation", - "ibandronate [Bonviva/Boniva]" - ], - "diseases": "['Post Menopausal Osteoporosis']", - "diseases_list": [ - "Post Menopausal Osteoporosis" - ], - "enrollment": "67.0", - "inclusion_criteria": "inclusion criteria: \n\n women who have been newly diagnosed with post-menopausal osteoporosis, requiring treatment; \n\n naive to bisphosphonate treatment,or had bisphosphonate treatment for a maximum of 3 months, at least 5 years before screening. \n\n ", - "exclusion_criteria": ": \n\n patients on hormone replacement therapy (HRT) within the last 3 months; \n\n patients on other osteoporosis medication within the last 3 months; \n\n sCTX below lower limit, or above 3 times the upper limit, of normal premenopausal level; \n\n hypersensitivity to any component of ibandronate; \n\n contraindication for calcium or vitamin D therapy; \n\n history of major gastrointestinal upset; \n\n malignant disease diagnosed within the previous 10 years (except resected basal cell cancer).", - "brief_summary": "This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated. Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with vitamin D and calcium supplementation. The anticipated time on study treatment is approximately 7 months, and the target sample size is <100 individuals.", - "NCTID": "NCT00303485" - }, - { - "brief_title": "Optimal Management of Women With Wrist Fractures", - "phase": "", - "drugs": "['Educational Material and Reminder']", - "drugs_list": [ - "Educational Material and Reminder" - ], - "diseases": "['Osteoporosis', 'Osteopenia']", - "diseases_list": [ - "Osteoporosis", - "Osteopenia" - ], - "enrollment": "270.0", - "inclusion_criteria": "inclusion criteria: \n\n Postmenopausal women with low trauma distal radius fracture (confirmed by x-ray). \n\n Can be taking Didrocal (etidronate), Miacalcin (calcitonin),or hormone replacement therapy . \n\n ", - "exclusion_criteria": ": \n\n Women with fractures of the elbow, mid radius, scaphoid, or injury to wrists (without actual fracture). \n\n Significant cognitive impairment (which would preclude them from filling out simple questionnaires). \n\n Women already taking osteoporosis therapy, ie. either Fosamax (alendronate), Actonel (risedronate), or the selective estrogen receptor modulator, Evista (raloxifene).", - "brief_summary": "To evaluate the effectiveness of a multifaceted intervention (reminder and educational material) in improving the evaluation of osteoporosis follow-up care of post-menopausal women with wrist fractures by their primary care physicians. The intervention is directed at improving the gap in continuity of care between emergency/fracture clinics and family physicians, and reducing knowledge gaps.", - "NCTID": "NCT00226031" - }, - { - "brief_title": "Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy", - "phase": "Phase 3", - "drugs": "['Alendronate', 'Placebo']", - "drugs_list": [ - "Alendronate", - "Placebo" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "436.0", - "inclusion_criteria": "inclusion criteria: \n\n Postmenopausal women or men > 60 years \n\n DXA T-Score at lumbar spine, total hip or femur neck <-2,0 before the start of the bisphosphonate therapy or at baseline or at least one low trauma vertebral fracture grade 2-3 or multiple low trauma vertebral fractures independent of bone mineral densitiy \n\n Pretreatment with bisphosphonates for at least four years \n\n Risk for hip and vertebral fractures min. 30% according to DVO-guideline for osteoporosis 2009 \n\n Signed informed consent \n\n ", - "exclusion_criteria": ": \n\n Other pharmacological treatment of osteoporosis during the last 48 months \n\n Other bone diseases \n\n Malabsorption syndromes \n\n Renal insufficiency with a calculated creatinine clearance < 35 ml/min \n\n Diseases of the esophagus, delayed esophageal clearance \n\n UUnability to realise the intake instructions \n\n Hypocalcemia", - "brief_summary": "The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.", - "NCTID": "NCT01512446" - }, - { - "brief_title": "Study of Investigational Drug in Osteoporosis (MK-0217-908)", - "phase": "Phase 3", - "drugs": "['Placebo', 'ibandronate']", - "drugs_list": [ - "Placebo", - "ibandronate" - ], - "diseases": "['Postmenopausal Osteoporosis']", - "diseases_list": [ - "Postmenopausal Osteoporosis" - ], - "enrollment": "203.0", - "inclusion_criteria": "inclusion criteria: -postmenopausal for at least 3 years, with osteoporosis at any of the following sites: [BMD > 2.0 standard deviations below young normal mean bone mass for the hip trochanter, PA lumbar spine (L1 to L4), total hip, or femoral neck based on the normative database provided by each individual manufacturer]. \n\n willing to take study-supplied calcium and vitamin D supplement (or equivalent) and to discontinue any non-study calcium supplements for run-in period and the duration of the study. ", - "exclusion_criteria": ": -pregnant or lactating, or of childbearing potential. \n\n participated in another therapeutic trial with an investigational compound within 30 days of randomization. \n\n history of hypersensitivity to any component of ibandronate tablets or has hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. \n\n an abnormality of the esophagus which delays esophageal emptying such as stricture or achalasia. \n\n unable to stand or sit upright for at least 60 minutes once a month. \n\n current use of illicit drugs, or history of drug or alcohol abuse within the past five years. \n\n has any of the following: hypocalcemia; any severe malabsorption syndrome; moderate or severe hypertension which is uncontrolled; new onset angina or myocardial infarction within six months of entry into the study; evidence for impaired renal function; organ transplantation; or other significant end organ diseases (genitourinary, cardiovascular, endocrine, hepatic, psychiatric, renal, hematologic, or pulmonary). \n\n history of or evidence of metabolic bone disease (other than postmenopausal bone loss). \n\n clinical fracture in the past year. \n\n is receiving or has received treatment prior to randomization which might influence bone turnover. \n\n is receiving or expected to receive during the course of the study any medication (other than study medication) which might alter bone or calcium metabolism, including Vitamin A in excess of 10,000 IU per day or Vitamin D in excess of 5000 IU per day, calcitonin, phenytoin, heparin, or lithium.", - "brief_summary": "The purpose of this study is to evaluate the efficacy and safety of an investigational drug in postmenopausal women with osteoporosis. The primary hypothesis of this study is that in postmenopausal women with osteoporosis, oral monthly ibandronate, at doses of 100 mg and 150 mg, does not achieve persistence in reduction of bone resorption throughout the monthly dosing interval, as demonstrated by a larger change in the serum carboxyterminal crosslinked telopeptide of Type I collagen (CTX-I) log-transformed fraction from baseline four weeks post dose compared to one week post dose, during the third month of treatment, in the participants taking ibandronate than in the participants taking placebo.", - "NCTID": "NCT00092053" - }, - { - "brief_title": "GIOP Prevention Among People With Rheumatoid Arthritis", - "phase": "", - "drugs": "['Tailored Materials', 'Tailored Materials Plus Physician Feedback', 'Generic Materials', 'No Information']", - "drugs_list": [ - "Tailored Materials", - "Tailored Materials Plus Physician Feedback", - "Generic Materials", - "No Information" - ], - "diseases": "['Osteoporosis', 'Rheumatoid Arthritis']", - "diseases_list": [ - "Osteoporosis", - "Rheumatoid Arthritis" - ], - "enrollment": "273.0", - "inclusion_criteria": "inclusion criteria: \n\n Meet American College of Rheumatology criteria for rheumatoid arthritis \n\n Taking an oral glucocorticoid equivalent to 5 mg/day of prednisone for at least one month prior to study entry \n\n Age 18 or older \n\n ", - "exclusion_criteria": ": \n\n Existing osteoporosis \n\n Pregnancy \n\n Breast feeding \n\n History of breast cancer \n\n Physician recommendation to limit calcium intake \n\n Class IV rheumatoid arthritis", - "brief_summary": "The ultimate objective of the proposed research is to improve the health-related quality of life of individuals with rheumatoid arthritis by reducing their risk of developing osteoporosis secondary to glucocorticoid therapy. The study has four specific aims.~Specific Aim 1: To obtain descriptive information concerning patients' knowledge, beliefs and behaviors with respect to osteoporosis and osteoporosis prevention.~Specific Aim 2: To identify factors that discriminate among patients in different stages of change with respect to each behavior of interest.~Specific Aim 3: To compare the effects of tailored versus generic educational materials on patient adherence to the ACR Guidelines for the Prevention of Glucocorticoid-Induced Osteoporosis.~Specific Aim 4: To determine if the effects of tailored educational materials are enhanced by concurrent feedback of information concerning patients' behavioral risk factor status to their physicians.", - "NCTID": "NCT00609830" - }, - { - "brief_title": "Investigation of the Effect of BONISTEIN(R) Bone Blend on Bone Mineral Density/Content and Biomarkers of Bone Health", - "phase": "", - "drugs": "['BONISTEIN(R) bone blend', 'Placebo']", - "drugs_list": [ - "BONISTEIN(R) bone blend", - "Placebo" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "70.0", - "inclusion_criteria": "inclusion criteria: \n\n Female \n\n Age 45 (inclusive) to 55 years (inclusive) \n\n Race: Caucasian \n\n Non-smokers / Smokers up to 10 cigarettes/day \n\n Postmenopausal hormone status: 1-3 years since the last spontaneous menstrual bleeding and a follicle-stimulating hormone concentration (FSH) >75 IU/ml and 17-estradiol (E2) of < 20 ng/L \n\n Years since menopause between 1-3 years \n\n Natural menopause or total hysterectomy with bilateral salpingo-oophorectomy \n\n Subjects with E2 results within the inclusion criteria range will be assessed on an individual basis if FSH level is less than 75 IU/ml \n\n Assessed as age-related healthy, based on a pre-study examination including medical history, physical examination, ECG, vital signs and clinical laboratory. The examination will be performed by a MD at the study site within 1-2 months prior planned study start for the individual subject. \n\n Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements. \n\n Ability to understand, speak, read and write the English language \n\n ", - "exclusion_criteria": ": \n\n T-score < -2.5 at total hip and spine (either or both) \n\n Suspect lack of compliance \n\n BMI > 30 or < 21 \n\n Use of HRT within the previous 6 months \n\n Use of any drug which might interfere with bone-metabolism (bisphosphate, estrogen receptor modulators, calcitonin) within the previous 12 months \n\n Systematic practice of high intensity exercise \n\n Vegetarian nutrition or any other extreme dietary habits \n\n Use of dietary supplements while on study, except multi vitamin. No wash out period for supplements - must stop before run-in period and refrain until the end of the study. \n\n Participant in any other study or donation of blood during the last 30 days before start of each dosing phase (T0). \n\n Total genistein blood concentrations of > 100 ng/ml measured at pre-study examination \n\n Known hypersensitivity or allergy to soy, purified isoflavones, peanuts, fish, and/or genistein. \n\n Hepatitis screen (serology) positive or not performed \n\n Drug screen positive or not performed (at least amphetamines, benzodiazepines, cannabinoides, opiates). \n\n Subjects on a weight reduction program or a medically supervised diet \n\n Unexplained weight loss or weight gain of more than 5 kg in the three months prior to the study \n\n History of liver or pancreas diseases \n\n Cardiovascular diseases, even AV-block I0 (PQ time > 220 ms) and QTc time > 450 ms \n\n History of breast cancer, endometrial cancer and other malignancy except basal and squamous cell skin cancer \n\n History of thromboembolism or deep venous thrombosis \n\n Any fractures within one year except for fingers, toes and facial bones \n\n Subjects with susceptibility for fractures as a history of being a faller \n\n Endometrial thickness > 6 mm \n\n Endometrial polyps \n\n Untreated hypo- or hyperthyroidism \n\n Insulin-dependent diabetes mellitus, Crohn's Disease, Cushing Disease etc. \n\n Any condition which might interfere with absorption of the investigational product (e.g. malabsorption syndrome) \n\n Co-medication: Anticoagulants, parathyroid hormones, corticosteroids, thiazide diuretic \n\n Subjects who, during the previous 24 months, received a total fee payment greater than 5'000 USD for participation in biomedical research", - "brief_summary": "The purpose of this study is to obtain information about the effect of a combination of genistein, PUFAs, vitamin K and D (BONISTEIN(R) bone blend) on bone health, determined as bone mass density/content and bone biomarkers after 6-months treatment in 70 healthy postmenopausal women. In addition, safety and tolerability will be investigated.", - "NCTID": "NCT00698984" - }, - { - "brief_title": "Dietary Phytoestrogens and Bone Metabolism", - "phase": "Phase 2", - "drugs": "['Dietary Phytoestrogens']", - "drugs_list": [ - "Dietary Phytoestrogens" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Postmenopausal \n\n Weight within 90% to 120% of ideal body weight \n\n 12 or more months since last menstrual period \n\n New York Metro Area resident \n\n ", - "exclusion_criteria": ": \n\n History of cancer, diabetes, or heart disease \n\n Smoker", - "brief_summary": "The purpose of this study is to determine whether dietary phytoestrogens are an effective alternative to postmenopausal exogenous estrogen replacement therapy in preventing bone loss.", - "NCTID": "NCT00010686" - }, - { - "brief_title": "In Vivo Hip Fracture Discrimination With Quantitative Computed Tomography (QCT)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Osteoporosis', 'Proximal Femur Fracture']", - "diseases_list": [ - "Osteoporosis", - "Proximal Femur Fracture" - ], - "enrollment": "107.0", - "inclusion_criteria": "inclusion criteria: \n\n Selection of cases: women with hip fracture \n\n woman aged 60 years and more \n\n clinical suspicion of osteoporosis based on the following: trivial trauma (fall from the standing position), history of vertebral fracture or visualization of a vertebral fracture by CT \n\n availability of radiographs of the proximal femur (anteroposterior view of the pelvis mandatory; anteroposterior and lateral views of the fractured hip optional) \n\n signature by the patient of the informed consent document \n\n ", - "exclusion_criteria": ": \n\n patient under 60 years \n\n current bisphosphonate, oestrogen, or SERM treatment started more than 3 months earlier; or past treatment with these medications stopped less than 6 months earlier \n\n hip arthroplasty on the other side \n\n fracture at the site of a bone lesion \n\n psychiatric disorder that might prevent the patient from giving informed consent or from remaining completely still for about 15 minutes during the investigations \n\n informed consent document not signed by the patient \n\n Selection of controls: \n\n The controls will be women without hip fracture matched on age to the cases. \n\n inclusion criteria: \n\n woman aged 60 years and more \n\n signature by the patient of the informed consent document \n\n ", - "brief_summary": "Numerous geometric and bone mineral density (BMD) parameters can be derived from quantitative computed tomography (QCT) images of the proximal femur analyzed using dedicated software. The primary objective is to evaluate the contribution of QCT-image analysis to the prediction of the osteoporotic hip fracture risk, as compared to the reference standard, namely, dual energy X-ray absorptiometry (DXA).~Study hypothesis: For predicting osteoporotic hip fracture, findings from QCT images of the proximal femur analyzed using dedicated software are superior over DXA measurements of proximal femoral BMD.", - "NCTID": "NCT01035177" - }, - { - "brief_title": "Role of T-cells in Post-Menopausal Osteoporosis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "19.0", - "inclusion_criteria": "inclusion criteria: \n\n Women between the age of 18-55, pre-menopausal by history (regular spontaneous menstrual bleeding every 21-35 days) or documented FSH <10, no current estrogen therapy, undergoing hysterectomy with (ovx) or without ovariectomy (control group) for benign gynecologic disease (fibroid uterus, endometriosis, dysfunctional uterine bleeding, chronic pelvic pain) or for prophylaxis against ovarian cancer (BRCA positive). \n\n ", - "exclusion_criteria": ": \n\n History of an active cancer including breast and uterine cancer, treatment with chemotherapy or glucocorticoids \n\n History of an immune deficiency syndrome including HIV infection \n\n History of severe anemia with hematocrit < 25.", - "brief_summary": "This is an observational study of women undergoing surgical menopause to determine whether T-cells play an important role in the etiology of post-menopausal osteoporosis. Subjects will examined before and after surgery and followed over a two year period to determine the biology of T-cells during this study period.", - "NCTID": "NCT00787904" - }, - { - "brief_title": "BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.", - "phase": "Phase 3", - "drugs": "['Ibandronate']", - "drugs_list": [ - "Ibandronate" - ], - "diseases": "['Post-Menopausal Osteoporosis']", - "diseases_list": [ - "Post-Menopausal Osteoporosis" - ], - "enrollment": "677.0", - "inclusion_criteria": "inclusion criteria: \n\n post-menopausal women; \n\n >=3 months daily or weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis. \n\n ", - "exclusion_criteria": ": \n\n inability to stand or sit in an upright position for at least 60 minutes; \n\n hypersensitivity to bisphosphonates; \n\n treatment with other drugs affecting bone metabolism; \n\n abnormalities of the oesophagus, which delay oesophageal emptying.", - "brief_summary": "This single arm study will assess participant preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Participants currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to identify participants who may benefit from a monthly Bonviva regimen. Eligible participants will then discontinue their present bisphosphonate treatment, and switch to monthly Bonviva 150mg per oral (po). At the beginning and end of Bonviva treatment, all participants will complete an Osteoporosis Patient Satisfaction Questionnaire. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.", - "NCTID": "NCT00545779" - }, - { - "brief_title": "Hormone Replacement in Young Women With Premature Ovarian Failure", - "phase": "Phase 2", - "drugs": "['TMTDS']", - "drugs_list": [ - "TMTDS" - ], - "diseases": "['Healthy', 'Osteoporosis', 'Premature Ovarian Failure']", - "diseases_list": [ - "Healthy", - "Osteoporosis", - "Premature Ovarian Failure" - ], - "enrollment": "250.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with karyotypically normal spontaneous premature ovarian failure (as defined by screening protocol 91-CH-0127, i.e. women who have at least 4 months of amenorrhea, two FSH levels above 40 mIU/ml, at least one month apart, and a normal 46, XX karotype, diagnosed with premature ovarian failure prior to the age of 40) who are between the age of 18 and 42 years will be candidates. \n\n ", - "exclusion_criteria": ": \n\n General: \n\n Smokers (more than 2 cigarettes per day). \n\n Alcohol users (more than 2 drinks of alcohol per day). \n\n Body mass index (BMI, kg/m(2)) greater than or equal to 30 and less than or equal to 19. \n\n Previous history of hip fracture or other active hip pathology. \n\n Abnormalities of the hip precluding the assessment of bone mineral density. \n\n Major dermatologic disorders, or a history of skin sensitivity to adhesive bandages, tape or transdermal matrix patches. \n\n Hirsutism score greater than 8. \n\n Acne score greater than 1. \n\n Hysterectomy \n\n Baseline free testosterone (FT) levels above the normal range (greater than 6.3 pg/ml in our current essay) and/or SHBG levels less than 36 nmol/L. \n\n Medical use: \n\n Any prior treatment in the past 6 months known to affect bone other than estrogen (i.e., calcitonin, biphosphonates, fluoride, anabolic steroids, testosterone, or herbal therapy that contains androstenedione, and DHEA). \n\n Current and/or past use of: diuretics, anticoagulants (heparin, Coumadin), glucocorticoid drugs, gonadotropin-releasing hormone agonist or antagonist therapy, chemotherapy. \n\n Medical history of: \n\n Anorexia nervosa, hyperprolactinemia, insulin-dependent diabetes, Cushing's syndrome, gastrectomy, osteogenesis imperfecta, mastocytosis, rheumatoid arthritis, long-term parenteral nutrition, hemolytic anemia, hemochromatosis and thalassemia, ankylosing spondylitis, multiple myeloma, Vitamin D deficiency, Paget's disease, primary hyperparathyroidism, hyperthyroidism, hypothyroidism, any cancer or any other major illness. \n\n Contraindications to hormone replacement therapy: \n\n Thromboembolic event associated with previous estrogen use History of endometrial cancer or hyperplasia \n\n History of breast cancer \n\n Hypertriglyceridemia (fasting triglyceride levels greater than 500 mg/dL) \n\n LDL greater than 190mg/dl \n\n Patients taking statins \n\n Serum Alkaline phosphatase greater than or equal to 2X the upper limit of normal \n\n Serum GGT greather than or equal to 2X the upper limit of normal \n\n Abnormal values on two or more hepatic panel tests \n\n Undiagnosed Vaginal Bleeding \n\n Known sensitivity to agents \n\n Note: We will include patients with premature ovarian failure on antidepressant medications, since today's most common antidepressant medication (Prozac) does not have a major import on cognitive function. However, we will note whether they are on these medications. \n\n CONTROL SELECTION CRITERIA: \n\n Healthy non-pregnant regularly menstruating women (cycles between 21 and 35 days), non-smokers, non-alcohol users, under no medications, using non-hormonal contraceptive methods (i.e. barrier methods of contraception, or sterilization) and with no intention to conceive within the following 3 years.", - "brief_summary": "The human ovary produces male sex hormones (androgen) and female sex hormones (estrogen). Currently, androgen is not included in hormone replacement therapy for women with premature ovarian failure. Present hormone replacement therapy (HRT) was designed to treat women who experience ovarian failure at menopause (around the age of 50). However, 1% of women will experience premature failure of the ovaries before the age of 40. There have been no studies conducted to determine proper hormone replacement therapies for these younger women. Some research suggests that the usual menopausal hormone replacement therapy is not adequate to protect young women with premature ovarian failure from developing osteoporosis. Women with premature ovarian failure have abnormally low levels of androgens circulating in their blood. This may contribute to the increase risk for osteoporosis.~This study will compare two treatment plans for women with premature ovarian failure. Treatment plan one will be physiological estrogen hormone replacement. Treatment plan two will be physiological estrogen hormone replacement plus androgen. The study will attempt to determine which plan is more beneficial to women in relation to osteoporosis and heart disease.~The hormones will be contained in patches and given by placing the patches against the patient's skin. The patches were designed to deliver the same amount of hormone as would be normally produced by the ovary in young women.~The success of the treatment will be measured by periodically checking the density of patient's bone in the leg (femoral neck bone) . Researchers will take an initial (baseline) measurement of bone density before beginning treatment and then once a year, for 3 additional years, during treatment. The study will also consider bone density of the spine, bone turnover, heart disease risk factors, and psychological state.", - "NCTID": "NCT00001951" - }, - { - "brief_title": "The Effects of Therapy With Teriparatide on Vascular Compliance and Osteoprotegerin/RANKL", - "phase": "", - "drugs": "['teriparatide']", - "drugs_list": [ - "teriparatide" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Postmenopausal women and men over the age of 40 who are starting therapy with teriparatide \n\n ", - "exclusion_criteria": ": \n\n Patients with diabetes mellitus \n\n current smokers \n\n patients with a history of organ transplantation \n\n Patients currently of previously on glucocorticoid therapy within the past year \n\n Patients with serum creatinine above 1.5 mg/dl, patients with uncontrolled hypertension (BP 140/90 or greater) \n\n Patients ineligible for teriparatide therapy: History of metabolic bone disease other than osteoporosis \n\n History of radiation therapy \n\n Patients pregnant or nursing \n\n History of bone metastasis or skeletal malignancies \n\n History of hypercalcemia", - "brief_summary": "The purpose of this study is to determine what effect teriparatide will have on vascular (blood vessel) compliance and osteoprotegerin (bone fluid)and RANKL levels (bone cells).", - "NCTID": "NCT00347737" - }, - { - "brief_title": "A Study of Ibandronate [Bonviva/Boniva] and Alendronate in Female Patients With Post-Menopausal Osteoporosis", - "phase": "", - "drugs": "['alendronate', 'ibandronate [Bonviva/Boniva]']", - "drugs_list": [ - "alendronate", - "ibandronate [Bonviva/Boniva]" - ], - "diseases": "['Postmenopausal Osteoporosis']", - "diseases_list": [ - "Postmenopausal Osteoporosis" - ], - "enrollment": "6054.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult patients, >/= 55 years of age \n\n Postmenopausal osteoporosis \n\n Patients who are in the opinion of the physician eligible to participate in this study \n\n ", - "exclusion_criteria": ": \n\n N/A", - "brief_summary": "This observational study will assess the compliance and persistence of patients, real life efficacy and safety of intravenously quarterly administered 3 mg ibandronate [Bonviva/Boniva] in comparison to oral alendronate generics in female patients with post-menopausal osteoporosis. The anticipated time of assessment is 12 months. The target sample size is 5000-7000 patients.", - "NCTID": "NCT01128257" - }, - { - "brief_title": "Bone Density and Serum Testosterone in Male Methadone Maintained Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Opiate Dependence', 'Osteoporosis', 'Erectile Dysfunction', 'Hypogonadism']", - "diseases_list": [ - "Opiate Dependence", - "Osteoporosis", - "Erectile Dysfunction", - "Hypogonadism" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n age 18 to 50 \n\n methadone maintenance for at least 12 months (for cases) \n\n stable dose of methadone for 6 months (for cases) \n\n willing to participate in the study \n\n competency in English \n\n male \n\n ", - "exclusion_criteria": ": \n\n previous diagnosis of sexual dysfunction \n\n previous diagnosis of osteoporosis \n\n serum creatinine > 2 mg/dL \n\n chronic opiate use (for controls) \n\n congestive heart failure \n\n illicit drug use", - "brief_summary": "This is a pilot study designed to answer the question Do men who are receiving methadone maintenance therapy have lower spinal bone densities compared with age-matched controls who are not receiving methadone therapy?~The primary aim is to assess whether the mean or median spinal dual-ray energy x-ray absorptiometry (DEXA) scan results are different between these two groups of male patients. Primary measurements include: spinal bone densitometry by DEXA scan.~The secondary aim is to examine the role of sex steroids in men receiving methadone maintenance therapy and their association with spinal bone density and sexual dysfunction. Secondary measurements include: serum testosterone, estradiol, lutenizing hormone, albumin, sex hormone binding globulin and Vitamin D levels; age; Brief Sexual Function Inventory; Dietary, smoking/alcohol use and physical activity; Medical history, surgical and medication use; length of time using illicit opiates and time on methadone maintenance therapy.", - "NCTID": "NCT00170339" - }, - { - "brief_title": "Bone Density in Patients With Schizophrenia", - "phase": "", - "drugs": "['No Intervention']", - "drugs_list": [ - "No Intervention" - ], - "diseases": "['Schizophrenia', 'Alcohol Abuse']", - "diseases_list": [ - "Schizophrenia", - "Alcohol Abuse" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n DSM-IV diagnosis of schizophrenia \n\n Onset of illness more than 5 years. \n\n ", - "exclusion_criteria": ": \n\n No severe Medical and endocrinological disorder", - "brief_summary": "People with chronic mental disorder such as schizophrenia and alcohol abuse are high risk groups for developing osteoporosis.~To evaluate the prevalence of bone mineral density in men patients with schizophrenia with alcohol abuse, the investigators will compare bone mineral density between patient with schizophrenia with and without alcohol abuse.", - "NCTID": "NCT00540267" - }, - { - "brief_title": "Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial", - "phase": "Phase 3", - "drugs": "['Vitamin D and calcium suplementation']", - "drugs_list": [ - "Vitamin D and calcium suplementation" - ], - "diseases": "['Fall', 'Fractures']", - "diseases_list": [ - "Fall", - "Fractures" - ], - "enrollment": "704.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged over 65 years with normal renal function \n\n Normal transaminase levels \n\n Normal calcium blood levels \n\n Not homebound (not immobilized) nor in socio-healthcare institutions. \n\n ", - "exclusion_criteria": ": \n\n Need for medical treatment with calcium or vitamin D \n\n Hypersensitivity to or contraindication for calcium or vitamin D \n\n Medical treatment that includes calcium or vitamin D \n\n Physical disability that impedes their collaboration \n\n Taking thiazide diuretics \n\n Oral anticoagulants \n\n Hormone replacement therapy \n\n Digitalis drugs \n\n Anticonvulsants or barbiturates \n\n Having any of the following diseases: \n\n Lithiasis \n\n Renal impairment (serum creatinine >1.4 mg/dl) \n\n Hypo or hyperthyroidism \n\n Paget's disease \n\n Chronic liver disease \n\n Tumors \n\n Sarcoidosis \n\n Impaired intestinal absorption or chronic alcoholism (>40 g/day).", - "brief_summary": "The first objective is to determine the efficacy of calcium and vitamin D supplementation at doses of 1200 mg and 800 IU, respectively, to reduce the incidence of falls and fractures in non-institutionalized elderly people.~The second objective is to measure and compare treatment groups (calcium and vitamin D vs placebo) as regards muscle strength and musculoskeletal function, bone mineral density, calcidiol level and treatment safety.", - "NCTID": "NCT01452243" - }, - { - "brief_title": "Analysis of Hypovitaminosis D and Osteopenia/Osteoporosis in Spinal Disease Patients Who Underwent a Spinal Fusion at Illinois Neurological Institute, Peoria, IL., a Retrospective Review From November 1, 2012 to October 31, 2014 and Prospective Pilot From July 1, 2015-June 30, 2016", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Hypovitaminosis D', 'Spinal Disease', 'Osteoporosis']", - "diseases_list": [ - "Hypovitaminosis D", - "Spinal Disease", - "Osteoporosis" - ], - "enrollment": "460.0", - "inclusion_criteria": "(Part 1, Retrospective Study) \n\n inclusion criteria: \n\n 50 years old or older. \n\n Patients with any form of spinal fusion surgery performed by Dr. Daniel Fassett, MD, MBA, Neurosurgeon at OSF-INI from November 1, 2012 to October 31, 2014. \n\n ", - "exclusion_criteria": ": \n\n Subjects diagnosed with chronic renal disease Stage IV or V, metastatic spinal disease, bariatric surgery, malabsorption syndrome, seizure medication and chronic steroid use greater than 3 months at time of surgery. \n\n (Part 2, Observational Study) \n\n (Screening period July 1, 2015-June 30, 2016) \n\n inclusion criteria: \n\n 50 years old or older. \n\n Serum Vitamin D level checked prior to or at surgery. \n\n BMD exam performed anytime within 2 years prior to surgery. \n\n Patients with any form of spinal fusion cervical, thoracic, lumbar, surgery performed by Dr. Daniel Fassett, MD, MBA, Neurosurgeon at OSF-INI from July 1, 2015 to May 31, 2016. \n\n ", - "brief_summary": "The purpose of this study is to determine if there is correlation between Vitamin D deficiency and spinal disease/spinal fusion surgery.", - "NCTID": "NCT02534714" - }, - { - "brief_title": "Prescribe Exercise for Prevention of Falls and Fractures: A Family Health Team Approach", - "phase": "", - "drugs": "['Identification of patients at risk, tailored exercise prescription, motivational interviewing, review of behavioural outcomes']", - "drugs_list": [ - "Identification of patients at risk", - "tailored exercise prescription", - "motivational interviewing", - "review of behavioural outcomes" - ], - "diseases": "['Fall and Fractures Prevention']", - "diseases_list": [ - "Fall and Fractures Prevention" - ], - "enrollment": "11.0", - "inclusion_criteria": "inclusion criteria: \n\n > age 65 \n\n Patient of the Centre for Family Medicine Family Health Team (CFFM FHT) \n\n Have at least one of the following: \n\n 2 or more falls in the past 12 months \n\n age 75 + \n\n high risk of fracture based on the CAROC \n\n difficulty with walking or balance as determined by attending physician \n\n acute fall \n\n history of a fragility fracture after the age of 50 \n\n ", - "exclusion_criteria": ": \n\n moderate to severe cognitive impairment \n\n moderate to severe neurologic impairment \n\n not able to communicate in English \n\n contraindications to exercise as determined by physician \n\n uncontrolled hypertension \n\n palliative care, current cancer, on dialysis \n\n participation in a similar exercise program including resistance training at least 3 times a week", - "brief_summary": "Falls and fractures are a leading cause of death and disability in the older adult population. The consequences of falls and fractures contribute substantially to health care costs and can have a significant negative impact on the quality of life of the individual. Exercise has been studied as an option to reduce fracture risk and prevent falls though improving balance and muscle strength. The prevention of falls is important, as a history of falls is strongly predictive of suffering another. Those who are at a high risk of fracture or falling require a patient specific assessment and individualized exercise prescription that is tailored to their needs. This kind of program may not be typically available within the community and at a low cost. These individuals may experience difficulty when trying to engage in exercise due to barriers such as a lack of transportation, and a lack of knowledge. As the first point of contact with the health care system for many family doctors are in the ideal position to deliver exercise advice to their patients. However, a lack of time and specialized skills in prescribing exercise make this difficult for many of them. As a result, family health teams who provide interdisciplinary patient centered care are becoming popular. In this model the care is shared and provided by the most appropriate team member (e.g. doctor, nurse, exercise specialist). Additionally, many exercise interventions do not include a behavior change aspect, which may be an important component when trying to get individuals to engage in a new health behavior like exercise. Therefore the purpose of this project is to assess the feasibility of implementing a tailored exercise program to those at high risk of falls or fractures over the age of 65 in a primary care setting using an interdisciplinary model of care that is based on a health behaviour change model.", - "NCTID": "NCT01698463" - }, - { - "brief_title": "The Efficacy of Vitamin K2 n Human Osteoporosis, Blood-vessel Calcification and Sclerosis", - "phase": "", - "drugs": "['Vit K2+ Vit D3+ calcium carbonate (CaCO3)', 'Vit K2+CaCO3']", - "drugs_list": [ - "Vit K2+ Vit D3+ calcium carbonate (CaCO3)", - "Vit K2+CaCO3" - ], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Men and non-pregnant women who are at least 20 years and under 75 years of age; and \n\n Female subjects cannot be pregnant or breast feeding. \n\n Patients who are, in the opinion of the Investigator, able to comply with the requirements of the study; and \n\n Patients who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving study medication. \n\n ", - "exclusion_criteria": ": \n\n Women who are pregnant, as determined by a urine pregnancy test, or breast-feeding. \n\n Presence or history of congestive heart failure (NYHA class III/IV) within the prior 12 weeks. \n\n Recent myocardial infarction (within the prior 12 weeks). \n\n Unstable angina pectoris. \n\n Known or suspected renal insufficiency defined as creatinine>1.5mg/dl. \n\n Known or suspected hepatic insufficiency defined as abnormal liver function tests (GOT/GPT) >3x upper normal limit (i.e., 120 U/l). \n\n Known hypomotility syndrome: (such as hypothyroidism or scleroderma). \n\n Recent major trauma within the prior 12 weeks. \n\n Recent surgery requiring anesthesia including coronary artery bypass graft (within 12 weeks). \n\n Recent hospitalization (within 12 weeks) \n\n Uncontrolled hypertension (defined as a systolic blood pressure>180mmHg or a diastolic blood pressure >105mmHg). \n\n Uncontrolled hyperlipidemia (defined as total cholesterol>240mg/dL or triglyceride >200mg/dL). \n\n Uncontrolled diabetes (defined as HbA1c>7%). \n\n Cigarette smoker (>=1/day). \n\n Acute infection requiring current antibiotic therapy. \n\n Current use of anticoagulant medication (e.g., warfarin). \n\n Recent or abrupt change (within 1 month) in usual diet. \n\n Use of an investigational drug (within 30 days prior to enrollment). \n\n Known allergies to the component of study medication \n\n Patients have acute disease, and in the opinion of investigators, are not suitable to participate in this study.", - "brief_summary": "This study used the generally recognized as safe (GRAS) grade of Bacillus subtilis natto to produce Vitamin K2, Menaquinone-7(MK-7), via fermentation, for functional evaluation. There are four major objectives for this study: (1) bioavailability of calcium; (2) evaluation of bone density improvement; (3) evaluation of blood-vessel calcification and sclerosis improvement; (4) safety evaluation.", - "NCTID": "NCT01928134" - }, - { - "brief_title": "The Effects of Aging and Estrogen on the Pituitary", - "phase": "Phase 2; Phase 3", - "drugs": "['GnRH', 'NAL-GLU GnRH antagonist', 'Estrogen patch']", - "drugs_list": [ - "GnRH", - "NAL-GLU GnRH antagonist", - "Estrogen patch" - ], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "19.0", - "inclusion_criteria": "inclusion criteria: \n\n 45-55 or 70-80 years old \n\n History of natural menopause defined by the absence of menses for at least 12 months (or history of surgical menopause defined as bilateral oophorectomy) and a FSH level >26 IU/L \n\n On no hormonal medication or herbal supplements and/or over the counter menopause therapy for a minimum of 2 months prior to study \n\n Normal thyroid stimulating hormone, prolactin, factor V Leiden, and complete blood count - Normal blood urea nitrogen and creatinine (< 2 times the upper limit of normal) \n\n basal metabolic index \u2264 30 \n\n Non-smokers or smoke less than 10 cigarettes/day \n\n ", - "exclusion_criteria": ": \n\n Absolute contraindications to the use of physiologic replacement doses of estrogen, including a negative screening mammogram within the past 24 months \n\n History of coronary artery disease \n\n On medications thought to act centrally on the GnRH pulse generator \n\n Past history of hypersensitivity or allergy to narcotics, vancomycin, muscle relaxants, aspirin, and/or anaphylactic reaction(s) to other drugs \n\n Prior history of breast cancer and/or blood clots", - "brief_summary": "The purpose of this study is to study the effects of aging and estrogen on the brain. Specifically, this study will examine how the hypothalamus signals the pituitary gland to secrete reproductive hormones and how that changes with aging.", - "NCTID": "NCT00386022" - }, - { - "brief_title": "Vitamin D Status in Relation to Insulin Sensitivity Among Saudi Women With Polycystic Ovary Syndrome", - "phase": "", - "drugs": "['Vitamin D3 pills', 'Placebo pills']", - "drugs_list": [ - "Vitamin D3 pills", - "Placebo pills" - ], - "diseases": "['Polycystic Ovary Syndrome']", - "diseases_list": [ - "Polycystic Ovary Syndrome" - ], - "enrollment": "340.0", - "inclusion_criteria": "inclusion criteria: \n\n PCOS diagnosis to include three of the Rotterdam criteria \n\n ", - "exclusion_criteria": ": \n\n pregnancy lactation taking vitamin d or calcium supplement in excess of a regular multivitamins diabetes mellitus uncontrolled hypertension liver disease renal disease secondary causes of hyperandrogenism metabolic bone disease thyroid dysfunction taking oral contraceptives taking hypoglycemic agents (metformin or thiazolidinediones) medication to affect plasma sex steroids for >/3 months before the study smokers", - "brief_summary": "The study tests the hypothesis that correction of vitamin D deficiency among women with PCOS will improve insulin sensitivity and resistance and inflammatory response to PCOS.", - "NCTID": "NCT02164552" - }, - { - "brief_title": "Systemic Consequences and Comorbidities in Mild/Moderate Chronic Obstructive Pulmonary Disease (COPD), Time for Action!", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n age 40-80 years old \n\n cases: spirometry (post-bronchodilator) based diagnosis of COPD (GOLD criteria) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment. \n\n smoking controls: no COPD (spirometry based) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment. \n\n non-smoking controls: no COPD (spirometry based) + < 1 pack year \n\n ", - "exclusion_criteria": ": \n\n Respiratory disorder other than COPD \n\n \u03b11-antitrypsin deficiency \n\n Known history of significant inflammatory disease other than COPD \n\n COPD exacerbation within 4 weeks prior to study \n\n Lung surgery \n\n Recent diagnosis of cancer \n\n Therapy with oral corticosteroids in the last 6 weeks \n\n Significant cardiovascular comorbidity \n\n Significant orthopedic/musculoskeletal problems", - "brief_summary": "The aim of this prospective case-control study is to investigate the prevalence, severity and incidence of systemic consequences in newly detected patients with mild and moderate Chronic obstructive pulmonary disease (COPD). Special attention will be paid to skeletal muscle dysfunction and physical inactivity as these factors are, together with smoking, potentially modifiable.", - "NCTID": "NCT01314807" - }, - { - "brief_title": "In-house Produced PMMA- Versus PEEK-cages", - "phase": "Phase 1; Phase 2", - "drugs": "['Implantation of a PEEK-cage', 'PMMA-cage']", - "drugs_list": [ - "Implantation of a PEEK-cage", - "PMMA-cage" - ], - "diseases": "['Cervical Disc Degeneration', 'Cervical Stenosis']", - "diseases_list": [ - "Cervical Disc Degeneration", - "Cervical Stenosis" - ], - "enrollment": "88.0", - "inclusion_criteria": "inclusion criteria: \n\n virgin spines \n\n no emergency operation \n\n age above 18 \n\n sufficient knowledge of the German language \n\n indication for anterior cervical discectomy and fusion \n\n absence of concomitant spinal disease \n\n ", - "exclusion_criteria": ": \n\n prior cervical surgery \n\n indications other than ACDF \n\n concomitant neoplastic, metabolic, severe general or infectious disease", - "brief_summary": "Subsidence of cervical cages is a common problem. For the study, a new polyacrylmethacrylate cage was designed and prospectively implanted in patients with a mono- or bilevel cervical pathology. As control, a commercially available PEEK-cage was used, patients were randomized using minimization randomization, controlling for age and bone mineral densitiy. The investigators hypothesize that the newly developed cage has similar clinical and radiological qualities compared to the PEEK-cage, but at a much more favourable cost-performance ratio.", - "NCTID": "NCT01607775" - } - ], - "1": [ - { - "brief_title": "Comparison of Osteoporosis Disease Management Strategies (0000-039)", - "phase": "", - "drugs": "['Disease Management Assessment']", - "drugs_list": [ - "Disease Management Assessment" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "4685.0", - "inclusion_criteria": "inclusion criteria: \n\n Members of the Harvard Pilgrim Health Plan \n\n ", - "exclusion_criteria": ": \n\n Individuals who are not members of the Harvard Pilgrim Health Plan", - "brief_summary": "The purpose of this study is to assess the impact of disease management interventions on bone mineral density screening rates and osteoporosis treatment rates in women age 50-64 years at high risk for osteoporosis.", - "NCTID": "NCT00145080" - }, - { - "brief_title": "Patient- and Physician-Based Osteoporosis Education", - "phase": "Phase 1", - "drugs": "['Osteoporosis Education']", - "drugs_list": [ - "Osteoporosis Education" - ], - "diseases": "['Osteoporosis', 'Osteoporosis, Postmenopausal']", - "diseases_list": [ - "Osteoporosis", - "Osteoporosis", - "Postmenopausal" - ], - "enrollment": "30000.0", - "inclusion_criteria": "inclusion criteria For Patients: \n\n PACE beneficiaries who filled at least one prescription for a drug of any type in the year prior to the study \n\n At high risk for osteoporosis: women and men 75 years or older, patients taking glucocorticoids or psychoactive medications, patients diagnosed with rheumatoid arthritis, and patients with a past fracture \n\n Have had an outpatient visit with a participating doctor based on Medicare outpatient claims \n\n inclusion criteria For Physicians: \n\n Primary prescribing physicians for PACE beneficiaries", - "exclusion_criteria": "", - "brief_summary": "Osteoporosis is an important public health problem. Osteoporosis can cause serious health complications and death and leads to increased medical costs. The purpose of this study is to identify an effective method of educating patients and health care professionals about the diagnosis and treatment of osteoporosis.", - "NCTID": "NCT00073190" - }, - { - "brief_title": "Osteoporosis Choice Decision Aid for Use of Bisphosphonates in Postmenopausal Women", - "phase": "", - "drugs": "['Osteoporosis Choice Decision Aid']", - "drugs_list": [ - "Osteoporosis Choice Decision Aid" - ], - "diseases": "['Osteoporosis', 'Bone Loss, Age Related', 'Postmenopausal Bone Loss', 'Postmenopausal Osteoporosis']", - "diseases_list": [ - "Osteoporosis", - "Bone Loss", - "Age Related", - "Postmenopausal Bone Loss", - "Postmenopausal Osteoporosis" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Female, post-menopausal women aged 50 to 90. \n\n Have a bone mineral density (BMD) evaluation resulting in a T-Score of <-1.0. \n\n Have a follow-up appointment with a provider in the areas of Family Medicine (FM), Primary Care Internal Medicine (PCIM), or POM. \n\n Have no major barriers (i.e., severe hearing impairment, dementia, require interpreter, etc.) to participation in shared decision-making (per provider's assessment) \n\n Enrollment is open to females of diverse racial backgrounds. \n\n ", - "exclusion_criteria": ": \n\n Currently taking a bisphosphonate. \n\n Not available for 6 month follow-up phone call.", - "brief_summary": "To develop a decision aid to support the decision to use (or not use) bisphosphonates in postmenopausal women at risk for osteoporotic fractures, and to assess the impact of the decision aid on start and six month adherence to bisphosphonates.", - "NCTID": "NCT00578981" - }, - { - "brief_title": "PTHrP and Osteoporosis", - "phase": "Phase 2", - "drugs": "[\"Parathyroid hormone-related protein or ''PTHrP''\"]", - "drugs_list": [ - "Parathyroid hormone-related protein or ''PTHrP" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Healthy caucasian postmenopausal females between 50-75 years of age with low bone mineral density at the lumbar spine or hip as measured using dual energy x-ray absorptiometry or DXA. \n\n ON estrogen replacement treatment for at least three years. \n\n ", - "exclusion_criteria": ": \n\n Heart, vascular, kidney, liver, lung, hormonal, musculo-skeletal disease (other than osteoporosis), rheumatic, blood diseases are ", - "brief_summary": "PTH-related protein, or ''PTHrP'', is a hormone which was discovered in 1987. As its name implies, it is closely related to another hormone discovered in the 1920's named parathyroid hormone or ''PTH''. PTH has been shown to be effective in treating osteoporosis in both animals and humans. PTHrP has been shown to be effective in treating osteoporosis in laboratory animals, and there are strong scientific reasons to think that it may be effective in humans as well. However, no human trials with PTHrP in the treatment of osteoporosis have been performed. The studies in this trial are focussed on determining whether PTHrP can indeed increase bone mass in postmenopausal women with osteoporosis, when administered daily by subcutaneous injection for three months.", - "NCTID": "NCT00021827" - }, - { - "brief_title": "Melatonin Osteoporosis Prevention Study", - "phase": "Phase 1", - "drugs": "['melatonin', 'sugar pill']", - "drugs_list": [ - "melatonin", - "sugar pill" - ], - "diseases": "['Osteoporosis', 'Osteopenia']", - "diseases_list": [ - "Osteoporosis", - "Osteopenia" - ], - "enrollment": "19.0", - "inclusion_criteria": "inclusion criteria: \n\n inclusion criteria include perimenopausal women, \n\n willingness to participate in the 6-month study, willingness to undergo testing of bone turnover markers before and after the drug therapies and willingness to provide a self-assessment on quality of life and sleep throughout the program. \n\n Subjects must be willing to take their treatments right before bed and to not to consume alcohol with this medication. \n\n ", - "exclusion_criteria": ": \n\n ", - "brief_summary": "Osteoporosis is one of the most common skeletal disorders. Today in the United States, 10 million individuals have osteoporosis and 34 million more have low bone mass or osteopenia, which places them at an increased risk of some day developing osteoporosis. Of the people affected by this problem, 68% are women.The current thinking on the development of osteoporosis is that the changes in bone turnover that occur with aging play a major factor. Many modalities of treatment are used to prevent the bone loss and increased fracture risk associated with osteoporosis and osteopenia. Melatonin supplementation may be another treatment modality that lowers risk of hip fracture in perimenopausal women. Melatonin can remodel bone in animal models and in culture. Melatonin works through melatonin receptors to form osteoblasts from human mesenchymal stem cells and has been shown to inhibit osteoclast activity in rodents. Melatonin levels have been correlated with modulating bone markers; low nocturnal levels of melatonin correlate with in an increase in bone marker metabolism and osteoporosis. It is been shown that women who have worked night-shifts for greater than 20 years have increased risk for wrist and hip fractures. Night-shift workers have lower nocturnal melatonin levels than people who do not work the night-shift. The addition of exogenous melatonin suppresses bone marker metabolism. In human stem cells taken from bone marrow, melatonin increases the activity of bone-forming cells called osteoblasts. It is hypothesized that melatonin will improve bone health, menopausal quality of life and sleep compared to placebo in perimenopausal women. In particular, the investigators expect perimenopausal women taking melatonin to show an improvement in overall bone health as revealed by a reduction in bone marker turnover since bone resorption increases more so than bone absorption in this population compared to those women taking placebo. We also expect that perimenopausal women taking melatonin to have better control over their menopausal symptoms, better quality of life and less sleep disturbances when compared to their placebo controls since melatonin is known to modulate estrogen levels in the body and regulate sleep. The data from these studies may provide novel and alternative uses for melatonin; in particular its use for the prevention and/or treatment of osteoporosis.", - "NCTID": "NCT01152580" - }, - { - "brief_title": "Bindex Ultrasonometer for Osteoporosis Diagnostics", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "135.0", - "inclusion_criteria": "inclusion criteria: \n\n Postmenopausal women and men referred for bone density examination. \n\n ", - "exclusion_criteria": ": \n\n Patients unable to sign consent for participation.", - "brief_summary": "Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture risk. Among 200 million osteoporotic patients (Tarantino, Cannata et al. 2007) most are diagnosed only after a fracture. We expect with our aging population to see a significant increase in the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic patients are not diagnosed and do not receive treatment for their condition.~This research plan describes a study for clinical validation of the novel ultrasound device (Bindex\u00ae, Bone Index Finland Ltd.). In a preliminary study, the technique has been validated in a Finnish postmenopausal woman population of 285 healthy and 56 osteoporotic subjects (n = 341 in total). Significant and good correlation was observed between Density Index (DI) determined with Bindex and femoral neck bone mineral density determined with DXA (r = 0.65 - 0.70). In addition, with determination of 90% sensitivity and specificity thresholds, significant number (65-75%) of patients could be diagnosed without additional verification with DXA.~For validation of the technique in US population, our study plan is presented for determination of diagnostic thresholds for osteoporosis. Taken together, DI with Bindex, lumbar spine and femoral bone BMD with DXA are obtained from 500 postmenopausal women and 140 men. The study will be carried out at the HealthEast Osteoporosis Care service in Woodbury, MN.~To investigate the capability of DI for prediction of proximal femur and lumbar spine BMD;~To develop national diagnostic thresholds for DI in prediction of osteoporosis status with a reference population (American-Caucasian) of 500 (if prevalence of osteoporosis is 20%) post-menopausal females (50-90 years);~To investigate ability of Density Index + FRAX with BMI in fracture risk prediction;~To investigate correlation between lumbar spine or proximal femur BMD and Density Index in 140 men at wide age range (20-90 years), 70 with osteoporosis and 70 with normal or low bone mass. Determine diagnostic thresholds for DI in men.", - "NCTID": "NCT01935232" - }, - { - "brief_title": "Effects of Phytoestrogen-rich Diets on Bone Turnover in Postmenopausal Women", - "phase": "", - "drugs": "['Isoflavones-enriched foods']", - "drugs_list": [ - "Isoflavones-enriched foods" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy as assessed by the: \n\n health and lifestyle questionnaire \n\n physical examination \n\n results of the pre-study laboratory tests \n\n Caucasian women \n\n Postmenopausal (\u226512 - \u226460 months since last menses), determined by \n\n interview \n\n FSH level \u2265 20 IU/l \n\n Body Mass Index (BMI) \u226522 - \u226429 kg/m2 \n\n Voluntary participation \n\n Having given their written informed consent \n\n Willing to comply with the study procedures \n\n Willing to accept use of all nameless data, including publication and the confidential use and storage of all data \n\n Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned \n\n ", - "exclusion_criteria": ": \n\n Participation in any clinical trial including blood sampling and/or administration of products up to 90 days before Day 01 of this study \n\n Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of products \n\n Osteoporosis, determined by \n\n Questionnaire (spontaneous bone fractures, use of medication to treat osteoporosis) \n\n DXA scans of the lumbar spine between day -14 and day 1 of the study; exclusion threshold is set at -2z score of BMD \n\n Severe scoliosis (curvature of the spine) that could interfere with the ability of the subject to go through the DXA scanning procedure and/or with a correct reading of the DXA scans \n\n Having a history of medical or surgical events that may significantly affect the study outcome, including: \n\n surgical menopause (including hysterectomy) \n\n antecedents and high familiar incidence of breast and/or endometrial cancer \n\n gastrointestinal disease (Crohn's, short bowel syndrome, coeliac disease, gastroenteritis episodes the month before the start of the study) \n\n hepatic disease (acute or viral hepatitis, chronic hepatitis) \n\n cardiovascular disease and thrombosis \n\n impaired renal function \n\n severe immune disease \n\n endocrine diseases (hyperthyroidism, hyperparathyroidism, IDDM, NIDDM) \n\n Food allergy as reported by the subject (with special emphasis on soy products) and reported allergy for sunscreen products \n\n Use of concomitant medication including \n\n Hormonal replacement therapy (during the study and within the last 6 months before day 01 of the study) \n\n Current use of corticosteroids (including Aerosol therapy) or past use for more than 10 days within the last 6 months \n\n Osteoporosis treatment (biphosphonates, SERM's, calcitonin, injectable PTH) \n\n Other medications known to affect bone metabolism (statins). Use of antibiotics will be carefully recorded. \n\n Change in smoking habits for the last 2 months \n\n Alcohol consumption > 21 units (drinks)/week \n\n Reported unexplained weight loss or gain of > 5 % of usual body weight in the month prior to the pre-study screening \n\n Reported slimming or medically prescribed diet \n\n Professional sportswomen (> 10 hours extensive sports/week) \n\n Reported vegan, vegetarian, macrobiotic food intake \n\n Regular intake of soy based foods (>2 servings per week). Participation is possible when the subject is prepared to stop consumption from screening until the end of the study \n\n Taking supplements containing isoflavones, in the 3 months prior to enrolment and during the study. Subjects should not start taking calcium and vitamin D supplements during the study. However, subjects who already take calcium and vitamin D supplements should maintain this intake during the study \n\n Recent blood or plasma donation (<1 month prior to the start of the study) \n\n Not willing to stop blood or plasma donation during the study \n\n TNO Nutrition and Food Research personnel, their partner and their first and second generation relatives \n\n Not having a general practitioner \n\n Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health. For example, laboratory results, findings at health and lifestyle questionnaire interview, or physical examination and eventual adverse events communicated to and from their general practitioner \n\n Mental status incompatible with the proper conduct of the study", - "brief_summary": "Osteoporosis is a major health problem. It was hypothesized that isoflavone-containing products may be a potential alternative to HRT for preventing bone loss during the menopausal transition. We investigated whether one-year consumption of isoflavone-enriched foods affected bone mineral density, bone metabolism and hormonal status in early postmenopausal women in a randomized double-blind, placebo controlled parallel multi-centre trial.", - "NCTID": "NCT00301353" - }, - { - "brief_title": "Periodontal Disease and Post-menopausal Osteoporosis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Osteoporosis', 'Osteopenia', 'Periodontal Disease']", - "diseases_list": [ - "Osteoporosis", - "Osteopenia", - "Periodontal Disease" - ], - "enrollment": "81.0", - "inclusion_criteria": "inclusion criteria: \n\n Women between 45-70 years with Absorptiometry Dual Energy X-ray (DEXA). \n\n Control group: post-menopausal women with periodontal disease and normal osseous condition. \n\n Study group: post-menopausal womens with periodontal disease and osteoporosis/osteopenia with and without bisphosphonate treatment (risedronate or ibandronate 150 mg) for longer than 3 months before the study and another. \n\n ", - "exclusion_criteria": ": \n\n Patients with history of aggressive periodontitis and had received any periodontal treatment when they entered the study \n\n Patients with any systemic illness (except osteopenia/osteoporosis) \n\n Patients who received antibiotic or non-steroidal anti-inflammatory therapy in the 6 months prior to the study.", - "brief_summary": "The aim of this study was to investigate the levels of RANKL and Osteoprotegerin, and their relationship in gingival crevicular fluid of post-menopausal women with osteoporosis/osteopenia and chronic periodontitis simultaneously and evaluate the effect that the use of bisphosphonates in periodontal disease.~Study hypothesis:~The osteoporosis / osteopenia in postmenopausal women patients with periodontal disease affect the ratio RANKL / OPG in gingival crevicular fluid samples favoring osteoclastogenesis processes ", - "NCTID": "NCT02184962" - }, - { - "brief_title": "Women's Health Habits Study", - "phase": "Phase 3", - "drugs": "['Brief Intervention', 'Diagnostic assessment']", - "drugs_list": [ - "Brief Intervention", - "Diagnostic assessment" - ], - "diseases": "['Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility']", - "diseases_list": [ - "Risk Drinking,Diabetes", - "Hypertension", - "Osteoporosis", - "Infertility" - ], - "enrollment": "611.0", - "inclusion_criteria": "inclusion criteria: \n\n - 1. has diabetes, hypertension, osteoporosis, or infertility 2. Not currently receiving treatment for alcohol or drug problems or substance related medical illness 3. Not currently experiencing physical dependence on alcohol, requiring medically supervised detoxification 4. Not currently abusing or physically dependent on opiates, cocaine, or other illicit drugs 5. Not currently pregnant. Subjects with infertility may become pregnant during the course of the study. \n\n 6. Not currently nursing. 7. Able to complete study measures. \n\n ", - "exclusion_criteria": ": \n\n Alcohol screen negative or drinks within NIAAA sensible drinking limits for women \n\n Does not agree to randomization and study terms", - "brief_summary": "The purpose of this randomized trial is to test the effectiveness of screening and brief intervention for risk drinking by nonpregnant women with specific medical problems exacerbated by excessive alcohol consumption. The medical problems are female factor infertility, hypertension, diabetes, and osteoporosis, conditions that are costly to treat and difficult to manage. Just as pregnant women are thought to be highly motivated to modify their alcohol consumption, so women with specific medical problems worsened by alcohol intake are an appropriate group to receive a brief intervention.", - "NCTID": "NCT00846638" - }, - { - "brief_title": "Markers of Bone Status in Diabetes Mellitus (Type 1 and Type 2)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Diabetes Mellitus', 'Osteoporosis', 'Osteopenia']", - "diseases_list": [ - "Diabetes Mellitus", - "Osteoporosis", - "Osteopenia" - ], - "enrollment": "197.0", - "inclusion_criteria": "inclusion criteria: \n\n Type 1 or type 2 diabetes. \n\n Age \u2265 50 years. \n\n Unaltered treatment of diabetes during the previous six months (no changes in drugs, but an increase or decrease in dose is accepted) and HbA1c is stable with a level of \u00b1 1 in the same period. \n\n HbA1c level\u2265 7 % through the previous six months. \n\n BMI between 19 og 35. \n\n Specific inclusion criteria for type 2 diabetes: \n\n Either treatment with metformin, sulfonylureas, dipeptidyl peptidase IV (DPP IV) inhibitors or glucagon-like peptide 1 (GLP-1) analogs. \n\n Treatment with insulin and insulin in the combination with metformin, sulfonylureas, DPP IV inhibitors or GLP-1 analogs. \n\n ", - "exclusion_criteria": ": \n\n HbA1C > 10% \n\n Pregnancy. \n\n Metal implanted at both ankles and wrists. \n\n Patients treated with: Antiresorptive (incl. hormone replacement therapy) or bone anabolic treatment, glucocorticoids, lithium and anticonvulsives. \n\n Patients with a bone disease other than osteoporosis. \n\n Vertebral fracture visible by vertebral fracture assessment (VFA). \n\n Patients with renal disease defined by estimated glomerular filtration rate(eGFR) < 50. \n\n Other medical disease in unstable phase (fx. cancer, hyperthyroidism). \n\n Heart failure; New York Heart Association (NYHA) class IV. \n\n Patients which the investigator does not believe is fit to participate in the study", - "brief_summary": "Objective To collate the bone status in type 1 and type 2 diabetics using biochemical markers and bone scans.~Methods:~This is a multicenter trial involving the University Hospitals of three major danish cities: Aalborg, Aarhus and Odense. The trial is of cross-sectional design and consists of examinations including:~Blood samples to analyze bone markers, glycemic state, kidney function and sex-hormones.~24 hour urine sample to analyze bone markers and kidney function.~Bone scans including dual energy x-ray absorptiometry (DXA) and high resolution peripheral quantitative computed tomography (HRpQCT) to evaluate Bone Mineral Density, t-score and bone structure.~Participants:~100 type 1 diabetics and 100 type 2 diabetics recruited from outpatient clinics at Aalborg, Aarhus and Odense, general practitioners and flyers.", - "NCTID": "NCT01870557" - }, - { - "brief_title": "Osteoprosis in Type 2 Diabetic Patients- a Cohort Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Type 2 Diabetes Mellitus', 'Osteoporosis']", - "diseases_list": [ - "Type 2 Diabetes Mellitus", - "Osteoporosis" - ], - "enrollment": "1200.0", - "inclusion_criteria": "inclusion:40-99 years old with type 2 DM patient \n\n exclusion:organization people", - "exclusion_criteria": "", - "brief_summary": "Some possible humoural and cellular mechanism for diabetes related osteoporosis/fractures were proposed and summarzied as the following, (1)Diabetes mellitus increases osteoclast function but decreases osteoblast function, thereby leading to accelerated bone loss, osteopenia and osteoporosis. (2)DM/hyperglycemia induces production of macrophage colony stimulating factor (MCSF), tumor necrosis factor (TNF)-\u03b1 and receptor activator of nuclear factor-\u03baB ligand (RANKL), all of which are osteoblast-derived activators of osteoclast proliferation and differentiation. (3) DM/hyperglycemia suppresses osteoblast proliferation and function, in part, by decreasing runtrelated transcription factor (Runx)-2, osteocalcin and osteopontin expressions. (4)Adipogenic differentiation of mesenchymal stem cells is increased as indicated by the overexpression of adipocyte differentiation markers, including peroxisome proliferator-activated receptor (PPAR)-g, adipocyte fatty acid binding protein (aP2), adipsin and resistin. A decrease in neovascularization may further aggravate bone loss. (5)Bone quality is also reduced as a result of advanced glycation end products (AGE) production, which may eventually result in low impact or fragility fractures. DM are associated osteoporosis/fracture. The underlying mechanism, especially of type 2 DM, mandates a DM-osteoporosis cohort to elucidate. In clinical practice, to developed preventive strategies from osteoporotic-fracture is also necessary.", - "NCTID": "NCT01846533" - }, - { - "brief_title": "Optimizing Vitamin D Nutrition in Healthy Adults", - "phase": "", - "drugs": "['Oral Vitamin D Supplementation']", - "drugs_list": [ - "Oral Vitamin D Supplementation" - ], - "diseases": "['Vitamin D Deficiency']", - "diseases_list": [ - "Vitamin D Deficiency" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy African-American and Caucasian adults aged 18-65 years. \n\n ", - "exclusion_criteria": ": \n\n Subjects who are not either African-American or Caucasian. The investigators plan to examine racial differences in response to oral vitamin D dosing and, therefore, have chosen the most affected (African-American) and the least affected (Caucasian) racial groups. Including other racial/ethnic groups may confound the results unless they are studied as separate groups. \n\n Any chronic medical illness including diabetes mellitus, history of myocardial infarction or heart failure, malignancy, hypertension (systolic blood pressure [SBP] > 140), obesity (body mass index [BMI] > 35 kg/m2), history of anemia, leukemia, or other hematologic abnormalities, lupus, rheumatoid arthritis, or other rheumatologic disease, or kidney disease of any kind as determined by history and physical examination. \n\n Subjects with osteoporosis or taking medications for osteoporosis such as bisphosphonates. \n\n Pregnancy. \n\n Use of medication that influences bone metabolism (i.e. anticonvulsant medications, steroids, diuretics). \n\n Significant deviation from normal in either history, physical examination, or laboratory tests, as evaluated by the primary investigator. \n\n Patients with a history of hypercalciuria, hypercalcemia, nephrolithiasis, and active sarcoidosis. \n\n Participation in another investigational trial in the past 30 days prior to the screening evaluation. \n\n Unexplained weight loss of > 15% during the previous year or history of anorexia nervosa. \n\n Medications that interfere with vitamin D metabolism. Oral contraceptive use will be allowed, but will be appropriately documented. \n\n Smokers greater than 1 pack per day. \n\n Patients reporting alcohol intake greater than 2 drinks daily. \n\n Subjects with baseline 25-OHD level greater than 80 nmol/L or less than 20 nmol/L.", - "brief_summary": "The purpose of this study is to determine the average dosage of oral vitamin D supplementation to maintain optimal vitamin D levels in the body and to see if there are differences in the response to oral vitamin D supplementation between African-American and Caucasian subjects.", - "NCTID": "NCT00327847" - }, - { - "brief_title": "Effects of Black Cohosh on Menopausal Hot Flashes", - "phase": "Phase 2", - "drugs": "['Black Cohosh']", - "drugs_list": [ - "Black Cohosh" - ], - "diseases": "['Postmenopause', 'Hot Flashes', 'Osteoporosis, Postmenopausal']", - "diseases_list": [ - "Postmenopause", - "Hot Flashes", - "Osteoporosis", - "Postmenopausal" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Resident of the New York Metro Area \n\n Postmenopausal \n\n Weight within 90% to 120% of ideal body weight", - "exclusion_criteria": "", - "brief_summary": "This study will assess whether treatment with black cohosh is effective in reducing the frequency and intensity of menopausal hot flashes. In addition, this study will determine whether or not black cohosh reduces the frequency of other menopausal symptoms and improves quality of life.", - "NCTID": "NCT00010712" - }, - { - "brief_title": "Study of a Community Based Approach to Control Cardiovascular Risk Factors in India", - "phase": "", - "drugs": "['Community health worker']", - "drugs_list": [ - "Community health worker" - ], - "diseases": "['Hypertension', 'Diabetes', 'Smoking', 'Cardiovascular Diseases']", - "diseases_list": [ - "Hypertension", - "Diabetes", - "Smoking", - "Cardiovascular Diseases" - ], - "enrollment": "1242.0", - "inclusion_criteria": "inclusion criteria: \n\n All individuals between the ages of 35 and 70 and residing in the area allotted to the CHW will be offered screening. \n\n Of the screened individuals, those with at least 1 cardiovascular risk factor (either one of Hypertension (BP>140/90), Diabetes (FBG >126) or current daily smoker (self-reported) will be enrolled in the study. \n\n ", - "exclusion_criteria": ": \n\n Individuals who are bed-bound because of acute illness, or have a chronic condition that makes them bed-bound. \n\n Individuals who refuse consent \n\n Individuals who do not reside in the community and are only visiting, therefore being unlikely to be available for continuous follow up. Individuals who have stayed less than 6 months in the study area, or whose name is not on the voter list of the area will be excluded. \n\n Individuals who are not able to participate in the intervention due to significant disabilities, such as blindness, deafness or the intellectually disabled.", - "brief_summary": "The study is a 2 year community based cluster randomized controlled trial to assess the role that a community health worker led intervention, in concert with physician education, can play in controlling the principal cardiovascular risk factors, i.e. hypertension, tobacco use, diabetes mellitus, physical inactivity and an unhealthy diet. Participants will include around 3600 adults, 35-70 years of age, from the urban community in the town of Dalkhola, Uttar Dinajpur district, West Bengal, India. The hypothesis of the study is that a community health worker based approach can result in increased control of Hypertension, Diabetes and Smoking.", - "NCTID": "NCT02115711" - }, - { - "brief_title": "Effectiveness of Spirometry as a Motivational Tool to Quit Smoking", - "phase": "", - "drugs": "['Spirometry and a brief advice to quit smoking', 'Brief advice to quit smoking']", - "drugs_list": [ - "Spirometry and a brief advice to quit smoking", - "Brief advice to quit smoking" - ], - "diseases": "['Smoking Cessation', 'COPD']", - "diseases_list": [ - "Smoking Cessation", - "COPD" - ], - "enrollment": "335.0", - "inclusion_criteria": "inclusion criteria: \n\n - Active smokers over 40 years and more than 10 pack-years \n\n ", - "exclusion_criteria": ": \n\n Previous diagnosis of respiratory disease (asthma, COPD, interstitial lung disease) that cause alteration of spirometric pattern. \n\n Patients with limitations in performing spirometry \n\n Age greater than 80 years \n\n Institutionalized patients \n\n Patients with a life expectancy less than 1 year \n\n Spirometry in the past 2 years", - "brief_summary": "The aim of the study is to asses the efficacy of the spirometry and a minimal smoking cessation counselling intervention to quit smoking after a year in patients older than 40 years, smokers of more than 10 packs-year and without a chronic obstructive pulmonary disease (COPD) diagnosis.", - "NCTID": "NCT01821885" - }, - { - "brief_title": "Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Type 2 Diabetes Mellitus']", - "diseases_list": [ - "Type 2 Diabetes Mellitus" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Have been diagnosed with type 2 diabetes mellitus \n\n Have an HgbA1c value \u2265 7% and \u226417%. \n\n Are on basal insulin, with or without oral agents \n\n Are not on basal bolus insulin therapy. \n\n Have had no severe hypoglycemic episodes in the 6 months prior to enrollment in the study. Severe hypoglycemia will be defined as any hypoglycemia that is both neurologically impairing and absolutely requires assistance from a third party in the form of carbohydrates, glucagon shots, or attention from a paramedic or other healthcare professional. \n\n Have no known allergy to medical tape or sensors. \n\n Are capable of and willing to test their blood glucose (BG) on an average of 4 times per day. \n\n Are willing to not use Acetaminophen while enrolled in the study. \n\n Are willing not to undergo a MRI procedure while wearing the CGM sensor. \n\n Are willing and capable of performing self insertions of the device sensor. \n\n Women of child bearing potential must be willing to use an approved form of birth control while enrolled in the study. \n\n Women of child bearing potential must be willing to perform pregnancy tests monthly while enrolled in the study. \n\n Can understand and speak English fluently. \n\n ", - "exclusion_criteria": " \n\n Have been on pump therapy in the 6 months prior to enrollment in the study. \n\n Are receiving basal- bolus insulin therapy \n\n Are taking any medication that is not approved to be taken with insulin. \n\n Are pregnant or have intentions of becoming pregnant during the duration of the study. \n\n Have any skin condition that would inhibit the proper wearing of the CGM sensor including severe psoriasis, burns, eczema, scarring, excessive tattoos, etc. \n\n Have a hematocrit \u226430% or \u226555% \n\n Are currently enrolled in another clinical study (subjects must have ended participation in other studies at least 30 days prior to enrolling in this study. \n\n Are employed by any company that manufactures or is developing a CGM device. \n\n Are deemed incapable of participating in the study by the Primary Investigator for any reason.", - "brief_summary": "The purpose of this study is to examine the effect CGM (continuous glucose monitoring) has on subjects with type 2 diabetes. It is anticipated that patients using the device will obtain tighter control of their blood sugars resulting in measureable health benefits and improved confidence in their ability to manage their diabetes.", - "NCTID": "NCT01341067" - } - ], - "2": [ - { - "brief_title": "Osteoporosis Screening Trial", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "5500.0", - "inclusion_criteria": "inclusion criteria: \n\n Females \n\n Postmenopausal women \n\n Outpatients screened for osteoporosis \n\n Women > 45 years \n\n Women < 45 years under menopause \n\n Women obtained their consent to be measured \n\n ", - "exclusion_criteria": ": \n\n Premenopausal females \n\n Women without any symptom of menopause \n\n Women not obtained their consent to be measured", - "brief_summary": "Osteoporosis is the most common disease of bone and characterized firstly by low bone mass and secondly, impaired bone microarchitecture structure resulting in reduced strength and increased risk of fracture. Osteoporosis is divided into: primary (Postmenopausal Osteoporosis Osteoporosis & elderly and senile osteoporosis) and secondary. The most common form is postmenopausal osteoporosis. It occurs in women after menopause and is associated with decreased estrogen production, which normally occurs at this age women Osteoporosis usually occurs after age 50, it is very common in women than in men, and its frequency increases with advancing age.", - "NCTID": "NCT01677637" - }, - { - "brief_title": "Development of Intervention Model for Osteoporosis and Fall Prevention in Taiwan", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "35.0", - "inclusion_criteria": "inclusion criteria: \n\n the risk of osteoporosis \n\n the risk of falls", - "exclusion_criteria": "", - "brief_summary": "Department of Chronic Disease and Health Promotion of World Health Organization listed eight classes of chronic disease which will be important globally in the future. And the sixth class is Chronic Rheumatic Condition, which includes rheumatic arthritis, osteoarthritis, osteoporosis, spinal disorders and severe limb trauma. Obviously the osteoporosis is a globally important health topic.~Osteoporosis draws more and more attention, because osteoporosis has various influences, for example, (1) psychologically impact which occurs frequently in many chronic diseases, such as depression will appear evidently in patients with osteoporosis (2) patients with osteoporosis often lose their social role (3) osteoporosis might induce pain and limitation of body function (4) osteoporosis increases greatly the possibility of fracture. Osteoporosis will induce adverse outcomes, such as the fall of life quality, the increase of morbidity and mortality, as well as the increased abuse of medical service. In this project, the investigators will set up the intervention model for prevention of osteoporosis as well as falls.~In this project, the investigators will recruit patients form outpatient services at WanFang Hospital. Through the collection of baseline data from questionnaire and bone density measurement, the investigators can clarify the risk of osteoporosis and falls in studied patients. By using double-blind randomized design, the patients will be collected to either one of intervention and control group. After eight weeks of intervention programs, the investigators will follow on both groups to understand the effect of this program and to increase the bone density of intervention group. The hospital or the Health center might take the outcome to be the reference of taking care the Osteoporosis.", - "NCTID": "NCT01206491" - }, - { - "brief_title": "Microarchitecture, Bone Strength and Fracture Risk in Type 2 Diabetes", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Type 2 Diabetes Mellitus', 'Bone Fractures']", - "diseases_list": [ - "Type 2 Diabetes Mellitus", - "Bone Fractures" - ], - "enrollment": "274.0", - "inclusion_criteria": "inclusion criteria: \n\n - presence of type 2 diabetes for at least 3 years (history of treatment for type 2 diabetes) \n\n ", - "exclusion_criteria": ": \n\n immobility \n\n coexisting metabolic bone disease or comorbidities affecting bone health \n\n previous treatment with osteoporosis medication or intake of medications known to affect bone metabolism (e.g. steroids) within 6 months prior to enrolment \n\n thiazolidinedione use", - "brief_summary": "This multicenter, prospective, observational cohort study will assess bone differences in women and men with type 2 diabetes mellitus (T2DM) with and without fragility fractures.", - "NCTID": "NCT02551315" - }, - { - "brief_title": "Point-of-care Osteoporosis Diagnostics With Bindex\u00ae Pocket Size Instrument and FRAX", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "1011.0", - "inclusion_criteria": "Osteoporosis suspicion \n\n inclusion criteria: \n\n Age: 50 - 59 years (n = 500) and 60-79 years (n = 500). \n\n Post-menopausal status. \n\n At least one of the clinical risk factors for fracture: \n\n Low body mass index (< 19kg/m2) \n\n Previous fragility fracture \n\n Parental history of hip fracture \n\n Glucocorticoid treatment (\u2265 5mg prednisolone daily or equivalent for 3 months or more) \n\n Current smoking \n\n Alcohol intake 3 or more units daily \n\n Causes of secondary osteoporosis: \n\n Untreated hypogonadism \n\n Inflammatory bowel disease \n\n Prolonged immobility \n\n Organ transplantation \n\n Type 1 and type 2 diabetes \n\n Thyroid disorders \n\n Chronic obstructive pulmonary disease \n\n A Physician has referred the woman to axial DXA investigation. \n\n ", - "exclusion_criteria": ": \n\n Treatment: osteoporosis medication. \n\n Obesity: body mass index BMI > 30kg/m2 \n\n a refusal to participate in the study \n\n Healthy \n\n inclusion criteria: \n\n Age: 50 - 59 years (n = 50) and 60-79 years (n = 50). \n\n Post-menopausal status. \n\n No diseases or treatments which may affect to bone health. \n\n ", - "brief_summary": "Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture risk. Among 200 million osteoporotic patients (Tarantino, Cannata et al. 2007) most are diagnosed only after several fractures. Furthermore, the progressively aging population will increase the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic patients are not diagnosed and does not receive treatment for their condition.~In this study we aim to investigate the strength of Density Index (DI) for prediction of proximal femur and lumbar spine BMD as well as determining the diagnostic thresholds for DI for osteoporosis diagnostics by using the International Society for Clinical Densitometry guidelines. In addition we aim to investigate how many additional women would be identified for osteoporosis diagnosis/ treatment based on adding FRAX to Bindex versus adding FRAX to DXA.~The investigators will start and organize a multicenter study in 5 osteoporosis clinics in Suomen Terveystalo Healthcare Service Company in Finland. A total of 1100 postmenopausal women (age 50 -79 years) will be measured with both axial DXA and Bindex. In addition, the FRAX questioinnaire will be asked from everybody attending the study.~Clinical hypotheses:~Cortical bone thickness is decreased in osteoporosis.~Patient age, weight and height are related to BMD status and therefore are needed in BMD estimation (Density Index).~Ultrasound is a safe method in osteoporosis screening and diagnostics for osteoporosis.~Fracture risk factors (FRAX) and point-of-care bone density measurement together have significantly higher sensitivity and specificity for osteoporosis/treatment decisions than one method alone.", - "NCTID": "NCT01998737" - }, - { - "brief_title": "Study of Post Menopausal Osteoporosis (PMO) Among Gynecology Outpatients in Pakistan", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Postmenopausal Osteoporosis']", - "diseases_list": [ - "Postmenopausal Osteoporosis" - ], - "enrollment": "624.0", - "inclusion_criteria": "inclusion criteria: \n\n Postmenopausal women \n\n Age 50 years or greater \n\n ", - "exclusion_criteria": ": \n\n Previously diagnosed osteoporosis, or receiving treatment for osteoporosis", - "brief_summary": "This observational study will provide an opportunity to document local patterns of susceptibility, patient profile, and usefulness of screening in postmenopausal patients coming to gynecology outpatient clinics in Pakistan. This will also capture the initial management of PMO in diagnosed patients. The information gathered will serve as a foundation for developing national guidelines on screening and management of PMO in Pakistan.", - "NCTID": "NCT02422069" - }, - { - "brief_title": "Clinical Value of Self-assessment Risk of Osteoporosis in Chinese", - "phase": "", - "drugs": "['questionaire']", - "drugs_list": [ - "questionaire" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "389.0", - "inclusion_criteria": "inclusion criteria: \n\n age of at least 20 years, able to read and fill out the questionnaire, and willingness to participate. \n\n ", - "exclusion_criteria": ": \n\n severe liver, heart, or kidney impairment, and tumor. Procedures of the study were in accordance with the Declaration of Helsinki and were approved by the local ethics committee.", - "brief_summary": "This cross-sectional study aimed to validate the effectiveness of the combined use of the Osteoporosis Self-Assessment Tool for Asians (OSTA) and the One-Minute Osteoporosis Risk Test (IOF test) in a population from Wuhan, China.", - "NCTID": "NCT02594592" - }, - { - "brief_title": "The Interaction Between Calcium and Vitamin D Intake", - "phase": "", - "drugs": "['Calcium and vitamin D supplementation']", - "drugs_list": [ - "Calcium and vitamin D supplementation" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "78.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy women aged 45 and above who have been menopausal at least 1 year (absence of menstrual period for a period of 12 months or more) \n\n ", - "exclusion_criteria": ": \n\n Any chronic medical illness including uncontrolled diabetes mellitus, recent history of myocardial infarction, or heart failure, malignancy, uncontrolled hypertension, obesity (BMI>35 kg/m2), history of anemia, leukemia, or other hematologic abnormalities, lupus, rheumatoid arthritis, or other rheumatologic disease, or kidney disease of any kind as determined by history and physical examination. \n\n Subjects with osteoporosis of the hip (total hip T-score equal or less than -2.5) or taking medications for osteoporosis such as bisphosphonates will be excluded. \n\n Pregnancy. \n\n Use of medication that influences bone metabolism (i.e. anticonvulsant medications, chronic use of steroids and high dose diuretics). \n\n Significant deviation from normal in medical history, physical examination, or laboratory tests as evaluated by the primary investigator. \n\n Patients with a history of hypercalciuria, hypercalcemia, nephrolithiasis, and active sarcoidosis will also be excluded. \n\n Participation in another investigational trial in the past 30 days prior to the screening evaluation. \n\n Unexplained weight loss of >15% during the previous year or history of anorexia nervosa. \n\n Medications that interfere with vitamin D metabolism. \n\n Patients with a habitual dietary calcium intake that exceeds 800 mg/day. \n\n Smokers greater than 1 pack per day will be excluded. \n\n Patients reporting alcohol intake greater than 2 drinks daily. \n\n Serum 25-hydroxyvitamin D level > 75 nmol/L.", - "brief_summary": "We will study the relative importance of high calcium intake and vitamin D supplementation for calcium homeostasis, as determined by serum parathyroid hormone (PTH) and biochemical bone markers. We also intend to examine the interaction of vitamin D and calcium intake on calcium homeostasis. We hypothesize that optimal calcium supplementation and optimal vitamin D supplementation will lead to lower serum levels of PTH and markers of bone resorption compared with the placebo. We also theorize that when taken together, optimal calcium supplementation and optimal vitamin D intake will result in lower serum levels of PTH and bone markers compared with calcium or vitamin D taken alone.", - "NCTID": "NCT00762775" - }, - { - "brief_title": "Age Dependend Diagnostic Thresholds for Osteoporosis Bindex Ultrasonometer", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "560.0", - "inclusion_criteria": "inclusion criteria: \n\n Female sex \n\n Age 50 to 89 years \n\n ", - "exclusion_criteria": ": \n\n Those who have opted out of being contacted for research on their general Park Nicollet clinic consent will not be recruited by mail \n\n Inability to sign consent form due to cognitive impairment. Those with dementia (ICD-9 diagnosis codes 331.0, 294.1, 294.10, 294.11, or 294.8) will excluded from mailed recruitment \n\n Measurement of hip BMD is not feasible (for example, those who have had bilateral hip replacement surgeries or who cannot have central DXA because of their body weight) \n\n Open leg or arm wounds at sites where ultrasound measurements are supposed to be taken, precluding such measurements", - "brief_summary": "This study is designed for clinical validation of the novel ultrasound device (Bindex\u00ae, Bone Index Finland Ltd.). In a preliminary study technique has been validated in Finnish elderly woman population with 285 healthy and 56 osteoporotic subjects (n = 341 in total). Significant and good correlation was observed between Density Index (DI) determined with Bindex and femoral bone mineral density determined with DXA (r = 0.65 - 0.70). In addition, with determination of 90% sensitivity and specificity thresholds, significant number (65-75%) of patients could be diagnosed without additional verification with DXA.~First, the thresholds for DI will be determined by measuring 70 osteoporotic and 70 healthy patients (n = 140) with Bindex and DXA within four decades of age; age 50 to 59 years, age 60 to 69 years, age 70 to 79 years, and age 80 to 89 years. The feasibility of DI for diagnostics of osteoporosis and evaluation of bone mineral density (BMD) will be assessed. The thresholds for the BMD estimate obtained with DI will be determined for osteoporotic and non-osteoporotic patients. For fracture risk assessment, DI measurements are used to predict the outcome of currently available fracture risk assessment tools.~To investigate optimal configuration of ultrasound parameters and patient characteristics for prediction of proximal femur and lumbar spine BMD for women in each four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.~To develop national diagnostic thresholds for DI in prediction of osteoporosis status with a reference female population (American-Caucasian) in each four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.", - "NCTID": "NCT01978834" - }, - { - "brief_title": "Does Bone Structure Explain the Increased Fracture Risk in Type II Diabetes Patients? A Pilot Study", - "phase": "", - "drugs": "['magnetic Resonance Imaging', 'Computed Tomography', 'High resolution peripheral quantitative computed tomography']", - "drugs_list": [ - "magnetic Resonance Imaging", - "Computed Tomography", - "High resolution peripheral quantitative computed tomography" - ], - "diseases": "['Osteoporosis']", - "diseases_list": [ - "Osteoporosis" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Postmenopausal female, 55-75 years old \n\n History of Type II diabetes, as defined by the American Diabetes Association for more than 5 years that is either insulin requiring or treated with oral therapies such as sulfonylureas and metformin \n\n Body mass index (BMI) of 19-35 \n\n Able to move without walkers and without a history of long periods (>3 months) of inactivity \n\n Additional inclusion criteria for fracture participants: \n\n Fractures of the proximal humerus and femur as well as the ankle and foot should have occurred after the onset of diabetes and should have been caused by a low energy trauma such as falling from standing height. All fractures will be verified by radiographs. \n\n ", - "exclusion_criteria": ": \n\n Severe neuropathic disease such as neurogenic osteoarthropathies (i.e., Charcot joints) of the foot \n\n Steroid users or have disease conditions that could play a significant role in the development of osteoporosis such as idiopathic osteoporosis, immobilization, hyperparathyroidism, or hyperthyroidism \n\n Diseases that may affect bone metabolism: alcoholism, chronic drug use, chronic gastrointestinal disease, renal or hepatic impairment \n\n Chronic treatment with antacids, estrogen, adrenal or anabolic steroids, anticonvulsants, anticoagulants, or pharmacologic doses of Vitamin A supplements 6 months prior \n\n Diabetic patients on rosiglitazone or pioglitazone medications \n\n high energy trauma, e.g., due to motor vehicle accidents \n\n Pathological fractures of other origin, i.e., tumor, tumor-like lesions as well as focal demineralization visualized on radiographs \n\n History of fluoride, bisphosphonate, calcitonin or tamoxifen use \n\n History of unstable cardiovascular disease or uncontrolled hypertension \n\n MRI contraindications \n\n Body mass index greater than 35", - "brief_summary": "For this cross-sectional case control pilot study 30 women, 55-75 years old with type II diabetes will be recruited. Diabetes will be defined as self-report of diabetes previously diagnosed by a physician, use of hypoglycemic medications, or fasting glucose > 126 mg/dl (7.0mM) in accordance with the American Diabetes Association criteria. The diabetic patient population will be divided into 2 groups: patients with status post low energy fractures of the proximal humerus, the proximal femur, the ankle and the foot (n=10) versus diabetic patients with no fractures or low energy trauma fracture history (n=10). An additional group of 10 diabetic postmenopausal women will be recruited and will have magnetic resonance imaging (MRI) of the lower back only. Caucasian, Asian and Hispanic women will be combined since a previous study suggested that BMD is very similar in these 3 population and that ethnic differences are minimal. In addition a population of 10 age-matched, BMI-matched, race-matched healthy women, without osteoporotic fractures will be examined. In all of these volunteers a medical history will be obtained to ensure good health status and rule out chronic diseases that would have an impact on bone metabolism. Patients will undergo MRI, QCT and high-resolution peripheral quantitative computed tomography (HR-pQCT) examinations to determine bone mineral density and bone structure/quality.~The hypothesis of this pilot project is that type II diabetic patients with and without low-energy fractures have a different trabecular bone architecture and composition, which is also different when compared to normal age-matched healthy patients. Architectural differences in these three patient groups may be visualized with high resolution MRI and high-resolution peripheral quantitative computed tomography (HR-pQCT) and will be most pronounced at the calcaneus and the distal tibia. Analyzing structure parameters obtained from high resolution MRI and spectroscopy may improve our understanding of the pathophysiology of diabetic bone disease and the prediction of fracture risk in an elderly diabetic population.", - "NCTID": "NCT00703417" - } - ] - }, - { - "patient_id": "sigir-201430", - "patient": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", - "0": [ - { - "brief_title": "Natural History of Peripheral Arterial Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Atherosclerosis', 'Coronary Disease', 'Arterial Occlusive Diseases', 'Peripheral Vascular Diseases', 'Cardiovascular Diseases']", - "diseases_list": [ - "Atherosclerosis", - "Coronary Disease", - "Arterial Occlusive Diseases", - "Peripheral Vascular Diseases", - "Cardiovascular Diseases" - ], - "enrollment": "", - "inclusion_criteria": "No eligibility criteria", - "exclusion_criteria": "", - "brief_summary": "The Veterans Administration Patient Study examined the progression of peripheral arterial disease (PAD) in patients with large vessel PAD or isolated small vessel PAD. The Community Follow-up Study following subjects with and without PAD from a previous cohort to determine subsequent coronary heart disease and cardiovascular disease morbidity and mortality.", - "NCTID": "NCT00005254" - }, - { - "brief_title": "Effects of Individualized Exercise Training in Patients With Peripheral Arterial Disease", - "phase": "", - "drugs": "['individualized exercise training']", - "drugs_list": [ - "individualized exercise training" - ], - "diseases": "['Peripheral Arterial Disease']", - "diseases_list": [ - "Peripheral Arterial Disease" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n Peripheral arterial disease post surgery > 1 month \n\n No discharge of surgical incision \n\n Intermittent claudication post invasive treatment \n\n ", - "exclusion_criteria": ": \n\n Necrosis \n\n Above/below knee amputee \n\n Other conditions might affect peripheral vascular elasticity", - "brief_summary": "The study is designed to investigate individualized exercise training effects on arterial function, walking ability and quality of life in subjects with peripheral arterial disease post surgery.", - "NCTID": "NCT00931112" - }, - { - "brief_title": "Screening DIVA - Diffuse Vascular Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Peripheral Vascular Diseases']", - "diseases_list": [ - "Peripheral Vascular Diseases" - ], - "enrollment": "2233.0", - "inclusion_criteria": "inclusion criteria: \n\n Documented acute coronary syndrome (Unstable angina, non-Q-wave myocardial infarction, Q-wave myocardial infarction) or/and documented ischemic stroke/transient ischemic attack (IS/TIA) \n\n ", - "exclusion_criteria": ": \n\n Previously known symptomatic or asymptomatic PAD confirmed by one of the following diagnostic methods or interventions (documented in the patient's medical record): \n\n Non-invasive or invasive vascular diagnostic tools (e.g.: ABI, Toe-brachial index, Duplex ultrasound, Magnetic resonance angiography, Computer tomographic angiography, Contrast angiography) \n\n Previous related intervention (such as angioplasty, stenting, atherectomy, peripheral arterial bypass graft, other vascular intervention including amputation) \n\n Patients whose ABI cannot be measured accurately \n\n Patients already in a clinical trial or a product registry \n\n Hospitalized patients \n\n The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.", - "brief_summary": "Primary Objective:~To investigate the value of the Edinburgh Claudication Questionnaire (ECQ) against the ankle-brachial index (ABI) in Canadian patients mainly followed in general practice, with documented acute coronary syndrome (ACS)/ischemic stroke (IS)/transient ischemic attack (TIA) and who are not known to have peripheral arterial disease (PAD) at the time of enrolment.~Secondary Objective:~To collect data on the prevalence of PAD in this population as measured by ABI.", - "NCTID": "NCT01076738" - }, - { - "brief_title": "Safety and Efficacy Study of a New Intermittent Pneumatic Compression Device to Treat Patients With Peripheral Arterial Disease (PAD) Stage II", - "phase": "", - "drugs": "['AngioPress Intermittent pneumatic compression (IPC) Device', 'Medications and Standard walking exercises']", - "drugs_list": [ - "AngioPress Intermittent pneumatic compression (IPC) Device", - "Medications and Standard walking exercises" - ], - "diseases": "['Peripheral Arterial Disease']", - "diseases_list": [ - "Peripheral Arterial Disease" - ], - "enrollment": "67.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female subject 18 to 90 years, of any race. \n\n Patients with proven Peripheral Arterial Disease (PAD) in Doppler Ultrasound and Ankle-Brachial Pressure Index (ABPI \u2264 0.9 in one leg) \n\n Subject with stable (>3 month) PAD Fontaine Stage II. \n\n Aortoiliac vessels with no significant hemodynamic disturbances , as confirmed by recent (<30 days) clinical examination \n\n Subject has intermittent claudication and claudication pain of the calf \n\n Subject has stable intermittent claudication (>3 month and not more than one year) with initial claudication distance not more than 250 meters, as determined by treadmill test (3.2 km/h, 10% grade) \n\n Subject willing to participate as evidenced by signing the written informed consent. \n\n Treatment with Aspirin or Clopidogrel for at least 7 days \n\n Willingness to undergo standardized walking exercise \n\n ", - "exclusion_criteria": ": \n\n Ankle-Brachial Pressure Index (ABI) above 0.8 in both legs. In Diabetic patients with no compressible arteries ABI above 40 mm/Hg of the higher pressure measured in both arms. \n\n Inability to walk \n\n Chronic respiratory insufficiency (severe obstructive or restrictive) \n\n Coronary artery disease with angina \n\n Stroke, myocardial infarction or other acute vascular events in the last 3 months \n\n Mild-Severe congestive heart failure \n\n Degenerative or inflammatory hip, knee, ankle or foot joint lesions interfering with walking \n\n Spinal stenosis or disc lesions with lower limb motor sensory defects \n\n Leg trauma, limb or skin infection or edema \n\n Recent (6 months) abdominal, cardiothoracic, vascular or orthopedic (lower limb) surgery \n\n Subject after crural or pedal bypass surgery \n\n Subject with neuropathy \n\n Uncontrolled arterial hypertension \n\n Morbid obesity (BMI >35.0) \n\n Need for concomitant medication with potential vascular activity \n\n Routinely use of pain relief medications (i.e. NSAIDs, Narcotics etc) \n\n Expected weak compliance \n\n Subject requires surgical or endovascular intervention for PAD \n\n Subject has known allergy to device components (sleeve fabric). \n\n Subject has medical conditions that may be worsened by concomitant use of the device (i.e. recent (1 year) Deep Vein Thrombosis). \n\n Subject participates in any other clinical study at the same time", - "brief_summary": "The purpose of this study is to evaluate the safety and efficacy of new intermittent pneumatic compression device on initial claudication distance in patients with Peripheral Arterial Disease stage II", - "NCTID": "NCT00762086" - }, - { - "brief_title": "Comparison of 2 Beta Blocker Drugs on Peripheral Arterial Disease in Patients With High Blood Pressure", - "phase": "Phase 3", - "drugs": "['nebivolol', 'Metoprolol succinate']", - "drugs_list": [ - "nebivolol", - "Metoprolol succinate" - ], - "diseases": "['Peripheral Artery Disease', 'Hypertension']", - "diseases_list": [ - "Peripheral Artery Disease", - "Hypertension" - ], - "enrollment": "17.0", - "inclusion_criteria": "inclusion criteria: \n\n Men and non-pregnant, non-lactating women 45 years of age or older \n\n Able to give informed consent and complete scheduled visits \n\n Mild-moderate bilateral lower extremity peripheral arterial disease as defined by an ankle-brachial index (ABI measurement of 0.6-0.9. If a subject has baseline claudication symptoms, the symptoms must be stable for the 3 months preceding enrollment. \n\n History of hypertension. Blood pressure at the screening visit must be \u2264160/100 mmHg and \u2265100/60 mmHg for all subjects. If a subject is currently prescribed beta-blocker therapy, BP at the screening visit must be \u2264140/90 mmHg. In addition, heart rate must be \u226555 beats per minute if currently prescribed a beta-blocker and \u226460 beats per minute if not currently prescribed a beta-blocker. \n\n At least moderate risk for CAD. \n\n ", - "exclusion_criteria": ": \n\n Participation in another clinical trial \n\n Ongoing ischemic (resting) limb pain, or lower extremity ulceration due to arterial insufficiency, or an ABI indicating <0.6 indicating disease potentially requiring revascularization \n\n History of limb or digit amputation due to arterial insufficiency \n\n Revascularization of peripheral vessels within the preceding 6 months \n\n Uncontrolled hypertension as defined by systolic blood pressure \u2265160 mmHg or diastolic blood pressure \u2265100 mmHg \n\n Contraindication or allergy to beta blocker therapy \n\n History of myocardial infarction , coronary revascularization, or a cerebrovascular event within the preceding 6 months \n\n Class III or IV angina \n\n Current or past history of New York Heart Association (NYHA) class III or IV heart failure \n\n Inability to walk on a treadmill for any reason \n\n Regular use of nitroglycerin or nitrates including oral, transdermal ointment or patch, or sublingual, translingual spray and/or combination agents containing nitrates \n\n Active liver, pulmonary, infectious or inflammatory process \n\n History of malignancy within preceding 5 years (excluding basal or squamous cell skin cancer) \n\n History of any other condition that, in the opinion of the investigators, renders it unsafe for the subject to be enrolled", - "brief_summary": "This is a 26-week, prospective double-blind, randomized pilot trial of nebivolol versus an active control, metoprolol succinate, in patients with established lower-extremity peripheral artery disease, hypertension, and at least moderate risk for coronary artery disease.", - "NCTID": "NCT01499134" - }, - { - "brief_title": "Effects of Dietary Flaxseed on Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease", - "phase": "Phase 2; Phase 3", - "drugs": "['Flaxseed', 'Placebo']", - "drugs_list": [ - "Flaxseed", - "Placebo" - ], - "diseases": "['Peripheral Arterial Disease']", - "diseases_list": [ - "Peripheral Arterial Disease" - ], - "enrollment": "110.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects with peripheral arterial disease for more than 6 months. \n\n Male or female with claudication secondary to lower extremity atherosclerotic arterial disease. (with limited IC but not incapacitated for walking on the level) confirmed with ankle/brachial pressures< or = to 0.9 in one or both legs) or who have had a previous intervention for peripheral arterial disease. \n\n Over 40 years old \n\n Able to comply with protocol requirements \n\n Able to provide informed consent \n\n Subjects taking anti-platelet therapy medication must be on a stable dose for 3 months prior to as well as during the study. \n\n Subjects taking lipid lowering medication must be on a stable dose for 3 months prior to as well as during the study. \n\n ", - "exclusion_criteria": ": \n\n Patients with ischemic rest pain in limbs, ulceration, or gangrene. \n\n At baseline, any condition that prevents walking on a treadmill. \n\n History of major bleeding. \n\n Patients with bowel disease (including Crohn's disease, celiac disease, peptic ulcer disease, irritable bowel syndrome and diverticulosis). \n\n Patients with an estimated life expectancy less than 2 years and with high baseline cardiac risk (post ischemic or diabetic cardiomyopathy with EF<40%, Canadian Cardiovascular Society Class 3 or 4 angina or need for coronary revascularization procedures). \n\n Moderate to severe renal failure. \n\n Subjects that are on supplements other that those prescribed by their clinician for the entire duration of the study. \n\n Fish limitations (no more than 2 fish meals per week) \n\n Gluten allergy \n\n Subjects with allergies to any ingredient in the study product or placebo. \n\n Patients who plan to undergo surgery during the course of the trial.", - "brief_summary": "This Clinical Trial is being conducted to study how patients with peripheral arterial disease (a condition in which the blood vessels of the extremities are affected) respond to a dietary regimen of flaxseed. The purpose of the study is to examine whether or not dietary flaxseed have any effect on improving symptoms of cardiovascular disease. Additionally, the effects of dietary flaxseed on exercise tolerance will be assessed.", - "NCTID": "NCT00781950" - }, - { - "brief_title": "Autologous CD34+ Stem Cell Injection for Severe Intermittent Claudication (Leg Pain)", - "phase": "Phase 1", - "drugs": "['Autologous Stem Cells (CD34+)']", - "drugs_list": [ - "Autologous Stem Cells (CD34+)" - ], - "diseases": "['Peripheral Artery Disease', 'Severe Intermittent Claudication']", - "diseases_list": [ - "Peripheral Artery Disease", - "Severe Intermittent Claudication" - ], - "enrollment": "24.0", - "inclusion_criteria": "inclusion criteria: \n\n Males or females equal to or greater than 21 years old \n\n Patients with infra-inguinal atherosclerosis with a stenosis or occlusion of a major vessel in the affected limb(s) of one or more of the following arteries: superficial femoral, popliteal, or one or more infrapopliteal arteries, which is/are non-reconstructable. \n\n Patients with symptoms of Severe Intermittent Claudication in at least 1 lower limb persisting for at least 6 months (Rutherford Class 3). \n\n Patients who have a diagnosis of Peripheral Arterial Disease (PAD) in at least 1 lower limb secondary to atherosclerosis, for at least 6 months. \n\n ", - "exclusion_criteria": ": \n\n Patients who have had successful aortic or lower extremity arterial surgery, angioplasty, or lumbar sympathectomy within 3 month preceding screening. \n\n Patients with iliac disease amenable to revascularization. \n\n Patients judged to be a suitable candidate for surgical or percutaneous revascularization in the limb in which treatment is proposed. \n\n Patients with Critical Limb Ischemia (CLI), Rutherford Symptom Score of 4,5, or 6. \n\n Patients in who arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder.", - "brief_summary": "The goal of the study is to determine the safety and possible effectiveness of various doses of autologous (one's own) stem cells, delivered with a needle into the regions of the leg with poor blood flow in patients with blocked leg arteries that results in claudication (pain when walking). Stem cells are primitive cells produced by the bone marrow that can develop into blood cells or other types of cells. In addition to determining whether this new approach is safe, the diagnostic tests may offer preliminary insights into the usefulness of this approach for treating intermittent claudication - the condition where areas in the leg are lacking enough oxygen and blood flow to keep the leg muscle working well, causing pain and cramping upon walking.~This study is a double-blind, randomized study to compare CD34-positive stem cells versus a placebo agent (salt water solution known as normal saline). The patient will have a 3:1 chance of their stem cells versus the placebo. Regardless of a patient receiving placebo or treatment, all patients will undergo all of the pre-treatment phases of this study, which includes the stem cell mobilization and apheresis procedure.", - "NCTID": "NCT00311805" - }, - { - "brief_title": "Preconditioning Shields Against Vascular Events in Surgery", - "phase": "", - "drugs": "['Remote ischaemic preconditioning']", - "drugs_list": [ - "Remote ischaemic preconditioning" - ], - "diseases": "['Abdominal Aortic Aneurysm', 'Carotid Atherosclerosis', 'Critical Lower Limb Ischaemia']", - "diseases_list": [ - "Abdominal Aortic Aneurysm", - "Carotid Atherosclerosis", - "Critical Lower Limb Ischaemia" - ], - "enrollment": "400.0", - "inclusion_criteria": "inclusion criteria: \n\n Age greater than 18 years \n\n Patient willing to give full informed consent for participation \n\n Patients undergoing elective carotid endarterectomy or \n\n Patients undergoing open abdominal aortic aneurysm repair or \n\n Patients undergoing endovascular abdominal aneurysm repair or \n\n Patients undergoing surgical lower limb revascularisation (suprainguinal or infrainguinal) \n\n ", - "exclusion_criteria": ": \n\n Pregnancy \n\n Significant upper limb peripheral arterial disease \n\n Previous history of upper limb deep vein thrombosis \n\n Patients on glibenclamide or nicorandil (these medications may interfere with RIPC) Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2 \n\n Patients with a known history of myocarditis, pericarditis or amyloidosis \n\n Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2. \n\n Patients with severe hepatic disease defined as an international normalised ratio >2 in the absence of systemic anticoagulation \n\n Patients with severe respiratory disease (for the trial, defined as patients requiring home oxygen therapy) \n\n Patients previously enrolled in the trial representing for a further procedure \n\n Patients with previous axillary surgery", - "brief_summary": "Major vascular surgery involves operations to repair swollen blood vessels, clear debris from blocked arteries or bypass blocked blood vessels. Patients with these problems are a high-risk surgical group as they have generalized blood vessel disease. These puts them at risk of major complications around the time of surgery such as heart attacks , strokes and death. The mortality following repair of a swollen main artery in the abdomen is about 1 in 20. This contrasts poorly with the 1 per 100 risk of death following a heart bypass. Simple and cost-effective methods are needed to reduce the risks of major vascular surgery. Remote ischaemic preconditioning (RIPC) may be such a technique. To induce RIPC, the blood supply to muscle in the patient's arm is interrupted for about 5 minutes. It is then restored for a further five minutes. This cycle is repeated three more times. The blood supply is interrupted simply by inflating a blood pressure cuff to maximum pressure. This repeated brief interruption of the muscular blood supply sends signals to critical organs such as the brain and heart, which are rendered temporarily resistant to damage from reduced blood supply. Several small randomized clinical trials in patients undergoing different types of major vascular surgery have demonstrated a potential benefit. This large, multi-centre trial aims to determine whether RIPC can reduce complications in routine practice.", - "NCTID": "NCT02097186" - }, - { - "brief_title": "Homocysteine and Progression of Atherosclerosis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cardiovascular Diseases', 'Peripheral Vascular Diseases', 'Atherosclerosis', 'Cerebrovascular Disorders', 'Myocardial Infarction', 'Heart Diseases', 'Hyperhomocysteinemia']", - "diseases_list": [ - "Cardiovascular Diseases", - "Peripheral Vascular Diseases", - "Atherosclerosis", - "Cerebrovascular Disorders", - "Myocardial Infarction", - "Heart Diseases", - "Hyperhomocysteinemia" - ], - "enrollment": "", - "inclusion_criteria": "No eligibility criteria", - "exclusion_criteria": "", - "brief_summary": "In the first phase, to establish the relationship of progression of peripheral vascular disease (PVD) to plasma homocysteine. In the second phase, to conduct a randomized, controlled trial of folic acid treatment of plasma homocysteine in peripheral vascular disease.", - "NCTID": "NCT00005338" - }, - { - "brief_title": "Individualized Prevention Strategy for High Risk Patients in Cardiovascular Disease: Prospective Cohort Study (Cardiovascular and Metabolic Disease Etiology Research Center - HIgh Risk Cohort) CMERC-HI", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['High Risk Cardiovascular Disease Patients']", - "diseases_list": [ - "High Risk Cardiovascular Disease Patients" - ], - "enrollment": "4000.0", - "inclusion_criteria": "inclusion criteria: \n\n high risk hypertension patients a. eGFR > 60 with one of target organ damages b. eGFR <= 60 \n\n diabetes mellitus with microalbumin ration (AC ratio >= 30mg/g) \n\n anuric ESRD patients on dialysis \n\n the relatives of acute myocardial infarction patients under 55 years old (men)/ 65 years old (women) \n\n atherosclerotic cardiovascular disease (abdominal aorta diameter \u22653 cm or ankle-brachial index <0.9, or carotid plaque or carotid intima-media thickness \u22650.9 mm, or asymptomatic old cerebrovascular accident, or >30% stenosis in at least one major coronary artery) \n\n rheumatoid arthritis patients aged > 40 years on MTX and steroid therapy \n\n atrial fibrillation patients with CHADS-VASc Score \u2265 1 \n\n kidney transplant recipient at > 3 months after transplantation \n\n ", - "exclusion_criteria": ": \n\n acute myocardial infarction, acute coronary syndrome patients, symptomatic coronary artery disease or history of these diseases \n\n symptomatic peripheral artery disease, heart failure and history of these diseases \n\n desired life time under 6 months due to non-cardiovascular disease (e.g. cancer, sepsis) \n\n women with pregnancy or on nursing \n\n history of contrast allergy and related side effects \n\n within the first three months after transplantation \n\n acute renal allograft rejection", - "brief_summary": "Set the prospective cohort (CMERC-HI) to study the known and novel etiologies and related factors for predicting clinical outcomes in Korean patients with high risk cardiovascular disease.", - "NCTID": "NCT02003781" - }, - { - "brief_title": "Preconditioning Shields Against Vascular Events in Surgery", - "phase": "", - "drugs": "['Remote preconditioning']", - "drugs_list": [ - "Remote preconditioning" - ], - "diseases": "['Abdominal Aortic Aneurysm', 'Carotid Atherosclerosis', 'Critical Lower Limb Ischaemia']", - "diseases_list": [ - "Abdominal Aortic Aneurysm", - "Carotid Atherosclerosis", - "Critical Lower Limb Ischaemia" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Age greater than 18 years \n\n patient willing to give full informed consent for participation \n\n Patients undergoing elective carotid endarterectomy or \n\n Patients undergoing open abdominal aortic aneurysm repair or \n\n Patients undergoing endovascular abdominal aneurysm repair or \n\n Patients undergoing surgical lower limb revascularisation (suprainguinal or infrainguinal) \n\n ", - "exclusion_criteria": ": \n\n Patients less than 18 years of age \n\n Patients who are unable or unwilling to give full informed consent \n\n Pregnancy \n\n Significant upper limb peripheral arterial disease \n\n Patients on glibenclamide or nicorandil (these medications may interfere with remote ischaemic preconditioning) \n\n Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2 \n\n Patients with a history of myocarditis, pericarditis or amyloidosis \n\n Patients undergoing Fenestrated or branched EVAR.", - "brief_summary": "Major vascular surgery involves operations to repair swollen blood vessels, clear debris from blocked arteries or bypass blocked blood vessels. Patients with these problems are a high-risk surgical group as they have generalized blood vessel disease. These puts them at risk of major complications around the time of surgery such as heart attacks , strokes and death. The mortality following repair of a swollen main artery in the abdomen is about 1 in 20. This contrasts poorly with the 1 per 100 risk of death following a heart bypass. Simple and cost-effective methods are needed to reduce the risks of major vascular surgery. Remote ischaemic preconditioning (RIPC) may be such a technique. To induce RIPC, the blood supply to muscle in the patient's arm is interrupted for about 5 minutes. It is then restored for a further five minutes. This cycle is repeated three more times. The blood supply is interrupted simply by inflating a blood pressure cuff to maximum pressure. This repeated brief interruption of the muscular blood supply sends signals to critical organs such as the brain and heart, which are rendered temporarily resistant to damage from reduced blood supply. Several small randomized clinical trials in patients undergoing different types of major vascular surgery have demonstrated a potential benefit. This large, multi-centre trial aims to determine whether RIPC can reduce complications in routine practice.", - "NCTID": "NCT01691911" - }, - { - "brief_title": "Study of the SafeSeal(TM) Hemostasis Patch Following Percutaneous Coronary Artery and Peripheral Vascular Interventions", - "phase": "Phase 4", - "drugs": "['SafeSeal(TM) Hemostasis Patch']", - "drugs_list": [ - "SafeSeal(TM) Hemostasis Patch" - ], - "diseases": "['Coronary Artery Disease', 'Peripheral Vascular Disease']", - "diseases_list": [ - "Coronary Artery Disease", - "Peripheral Vascular Disease" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient \u2265 18 years old \n\n Coronary or peripheral vascular intervention \n\n 6 French arterial sheath used \n\n Overnight hospitalization following procedure \n\n ", - "exclusion_criteria": ": \n\n Hematoma or persistent bleeding around the vascular sheath \n\n Previous AV fistula or pseudoaneurysm in the ipsilateral femoral artery \n\n History of bleeding diathesis or coagulopathy \n\n Hemoglobin level < 9 g/dl \n\n Inability to ambulate at baseline \n\n Known allergy to any of the materials used in the SafeSeal \n\n Female patients known to be pregnant or lactating \n\n Evidence of ongoing systemic or cutaneous infection \n\n Uncontrolled blood pressure following PCI (systolic blood pressure > 180 or diastolic blood pressure >110) \n\n Current enrolment in another ongoing investigational drug/device trial.", - "brief_summary": "We seek to determine if the use of the SafeSeal(TM) topical hemostasis patch is associated with reductions in time to hemostasis and time to ambulation compared to standard manual compression after arterial sheath removal following percutaneous coronary and peripheral intervention. We further seek to assess the safety of the SafeSeal patch compared to manual compression.", - "NCTID": "NCT00481741" - }, - { - "brief_title": "The Burden of Peripheral Artery Occlusion Disease and Associated Factors in Peritoneal Dialysis Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Peripheral Vascular Diseases']", - "diseases_list": [ - "Peripheral Vascular Diseases" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Receive stable peritoneal dialysis patients for more than 3 months \n\n ", - "exclusion_criteria": ": \n\n Active infection, malignancy and recent hospitalization", - "brief_summary": "The investigators want to evaluate the burden of peripheral artery occlusion disease in Taiwan peritoneal dialysis (PD) patients by using ankle-brachial pressure index (ABI) and toe-brachial pressure index (TBI). Furthermore, the investigators hope to demonstrate the possible casual factors of peripheral artery occlusion disease (PAOD) in PD patients.", - "NCTID": "NCT00173602" - }, - { - "brief_title": "Safety, Efficacy, and Pharmacokinetics (PK) Study of Trans Sodium Crocetinate (TSC) in Patients With Intermittent Claudication", - "phase": "Phase 1; Phase 2", - "drugs": "['Trans sodium crocetinate (TSC)', '0.9% normal saline']", - "drugs_list": [ - "Trans sodium crocetinate (TSC)", - "0.9% normal saline" - ], - "diseases": "['Intermittent Claudication']", - "diseases_list": [ - "Intermittent Claudication" - ], - "enrollment": "48.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged 40 or older, male or female \n\n 6-mo. history of walking limitation or symptoms of intermittent claudication (IC) in at least 1 lower limb, severity of which has not changed in the past 3 mo. and diagnosed by principal investigator as clinically stable Fontaine Stage II peripheral artery disease (PAD) \n\n Diagnosis of PAD secondary to atherosclerosis \n\n If ankle-brachial index (ABI) is > 1.3 or cannot be measured in either leg, vascular etiology documented by toe-brachial index (TBI) \u2264 0.7 in at least 1 leg \n\n Claudication severity, meds. for the treatment of coronary artery disease (CAD), PAD and IC, and exercise habits should be clinically stable for 3 mo. prior to Screening (SCRN) and during study. Pt. is not likely to change smoking and/or exercise habits during study \n\n On an exercise treadmill test (ETT), peak walking time (PWT) of at least 1 min., but no more than 12 min. at Baseline \n\n Willing and able to discontinue Pletal or Trental for 21 days before SCRN and during study \n\n Antihypertensive therapy, cholesterol-lowering therapy, chronic oral nitrates, and diabetic therapy have been stable for 30 days prior to SCRN \n\n Willing and able to provide written, signed, informed consent after the nature of the study has been explained and prior to any research-related procedures \n\n Willing and able to comply with all study-related procedures \n\n Sexually active patients must use an acceptable method of contraception while participating in the study \n\n Females of childbearing potential must have a negative pregnancy test at SCRN and have additional pregnancy tests during the study \n\n ", - "exclusion_criteria": ": \n\n Pregnant or lactating \n\n Current or history of critical limb ischemia (CLI) \n\n Pts. in whom artery insufficiency in the lower extremity is the result of acute limb ischemia (ALI) or an immunological or inflammatory non-atherosclerotic disorder \n\n Pts. in whom walking impairment due to pain is the result of other non-atherosclerotic co-morbid conditions \n\n A surgical intervention to alleviate symptoms of IC or PAD-specific endovascular intervention or cardiovascular surgery within 3 mo. of SCRN \n\n Walking limited by reasons other than claudication \n\n Conditions other than IC of significant severity that could confound PWT on the ETT \n\n Concurrent severe congestive heart failure (CHF) \n\n Life-threatening ventricular arrhythmias, unstable angina, and/or myocardial infarction (MI) within 3 mo. before enrollment (ENRL) \n\n Coronary artery bypass grafting or percutaneous coronary intervention within 4 mo. before ENRL \n\n Renal and/or carotid revascularization procedure within 3 mo. of ENRL \n\n Transient ischemic attack (TIA) within 3 mo. before ENRL \n\n Deep vein thrombosis (DVT) within 3 mo. before ENRL \n\n Severe chronic obstructive pulmonary disease (COPD) \n\n Thrombocytopenia \n\n Undergoing hemodialysis or peritoneal dialysis \n\n Pts. w/immunocompromised conditions, organ transplant recipients and/or need for immunosuppressive therapy \n\n Neurological dementia \n\n Stroke \n\n Clinically significant electrocardiogram (ECG) change during or after ETT at SCRN or Baseline visit(s) \n\n Cerebrovascular infarct within 3 mo. of SCRN \n\n Poorly controlled type 1 or type 2 diabetes at SCRN \n\n History of migraine headaches within last 12 mo. \n\n Patients with clinically significant abnormal hematology labs or blood chemistry labs \n\n Body mass index > 35 \n\n Hypertension at SCRN defined as resting BP values of > 170 mmHg systolic and/or > 110 mmHg diastolic \n\n Hypotension at SCRN defined as resting BP values < 100 mmHg systolic or < 55 mmHg diastolic or symptomatic hypotension \n\n Previous treatment with any formulation of TSC \n\n Known allergy or hypersensitivity to any excipient (gamma-cyclodextrin, mannitol, glycine) of TSC formulation \n\n Previous treatment with gene therapy or other VEGF-related treatment within 12 mo. of SCRN \n\n Patients with recent history of alcoholism or drug abuse, or severe emotional, behavioral, or psychiatric problems \n\n Patients receiving experimental medications or participating in other study using an experimental drug or procedure within 45 days prior to ENRL", - "brief_summary": "The purpose of this study is to evaluate the safety and pharmacokinetics of multiple, once-daily, intravenous doses of trans sodium crocetinate (TSC). The effectiveness of TSC in alleviating the symptoms of intermittent claudication (IC) will also be assessed.", - "NCTID": "NCT00725881" - }, - { - "brief_title": "Exercise Training for Patients With Poor Leg Circulation", - "phase": "", - "drugs": "['Physical exercise', 'Physical walking']", - "drugs_list": [ - "Physical exercise", - "Physical walking" - ], - "diseases": "['Diabetes Mellitus, Type 2', 'Intermittent Claudication']", - "diseases_list": [ - "Diabetes Mellitus", - "Type 2", - "Intermittent Claudication" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Group I (n=25 PAD patients). This sample will represent the population of veterans with PAD with mild mobility impairment secondary to intermittent claudication in the gastrocsoleus muscles. \n\n inclusion criteria for PAD Subjects: \n\n diagnosis of PAD (acute or chronic occlusive arterial disease), with or without diabetes mellitus \n\n positive Edinburgh Claudication Questionnaire \n\n Fontaine stage IIa only (mild claudication, walking distance > 200 feet (one-half block) \n\n ambulatory, without assistive devices \n\n calf muscle claudication within 10 minutes of treadmill walking and calf muscle exercise \n\n Group II (n=25 normal control/reference subjects). This reference sample will represent the population of adults without PAD and related problems. They will undergo the PET-exercise testing for perfusion and glucose metabolism measurements, but will not perform the exercise training intervention. \n\n inclusion criteria for Controls: \n\n healthy adults, matched by age and sex to PAD subjects \n\n ", - "exclusion_criteria": ": \n\n ", - "brief_summary": "The purposes of this pilot project are to (a) determine changes in calf muscle blood flow and energy supply resulting from calf muscle exercise, and (b) to determine changes in these variables resulting from exercise training (walking and calf muscle exercise). This is a pilot study to prepare for a larger project in the future. Exercise and exercise training should increase blood flow and energy supply to the calf muscles.", - "NCTID": "NCT00118560" - }, - { - "brief_title": "Peripheral Perfusion Targeted Fluid Management", - "phase": "Phase 4", - "drugs": "['PPTFM']", - "drugs_list": [ - "PPTFM" - ], - "diseases": "['Sepsis', 'Severe Sepsis']", - "diseases_list": [ - "Sepsis", - "Severe Sepsis" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n All adult patients (>18 years) admitted to the intensive care with 1) hemodynamic instability due to severe sepsis, and 2) a mean arterial pressure < 65 mmHg and 3) an arterial lactate concentration > 3.0 mmol/L will be considered for participation \n\n ", - "exclusion_criteria": ": \n\n moribund. \n\n severe coagulation disorder (contraindication for central venous catheter placement). \n\n severe peripheral vascular disease (interfering with peripheral perfusion measurement).", - "brief_summary": "Impaired peripheral perfusion is related to worse outcome in critically ill patients. Although this is known, these parameters have never been used as target for hemodynamic therapy.~We hypothesize that targeting of fluid administration on parameters of peripheral perfusion might prevent excessive fluid administration, leading to less formation of tissue edema, less respiratory dysfunction and shorter duration of mechanical ventilation in critically ill patients.", - "NCTID": "NCT01397474" - }, - { - "brief_title": "Epidemiologic Study to Evaluate the Proportion of Cardiovascular Disease Risk Factors in Korean Hypertensive Patients", - "phase": "", - "drugs": "['Blood Sampling']", - "drugs_list": [ - "Blood Sampling" - ], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "3109.0", - "inclusion_criteria": "inclusion criteria: \n\n Essential hypertensive patient no less than 18 yeas old \n\n Patient who gave informed consent form \n\n ", - "exclusion_criteria": ": \n\n Patient was diagnosed as secondary hypertension \n\n Patient who have white-coat hypertension", - "brief_summary": "The purpose of this study is investigating the proportion of Cardiovascular disease risk factors of hypertensive patients.", - "NCTID": "NCT01362283" - }, - { - "brief_title": "Strong Heart Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cardiovascular Diseases', 'Heart Diseases', 'Atherosclerosis', 'Asthma', 'Carotid Artery Diseases', 'Coronary Disease', 'Hypercholesterolemia', 'Hypertension', 'Diabetes Mellitus', 'Obesity']", - "diseases_list": [ - "Cardiovascular Diseases", - "Heart Diseases", - "Atherosclerosis", - "Asthma", - "Carotid Artery Diseases", - "Coronary Disease", - "Hypercholesterolemia", - "Hypertension", - "Diabetes Mellitus", - "Obesity" - ], - "enrollment": "", - "inclusion_criteria": "No eligibility criteria", - "exclusion_criteria": "", - "brief_summary": "To determine morbidity and mortality from cardiovascular disease among American Indians and to compare cardiovascular disease risk factor levels among Indian groups living in different geographic areas.", - "NCTID": "NCT00005134" - }, - { - "brief_title": "PTA and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia", - "phase": "Phase 2; Phase 3", - "drugs": "['PTA with placement of paclitaxel-eluting stent', 'PTA']", - "drugs_list": [ - "PTA with placement of paclitaxel-eluting stent", - "PTA" - ], - "diseases": "['Peripheral Vascular Disease']", - "diseases_list": [ - "Peripheral Vascular Disease" - ], - "enrollment": "144.0", - "inclusion_criteria": "inclusion criteria: \n\n Written informed consent \n\n Age > 18 years \n\n If female patient with child bearing potential, patient may not be pregnant at the study entry and must utilize reliable birth control for the duration of her participation into the study \n\n Patient is willing and able to comply with the specified follow-up evaluation \n\n Critical Limb Ischaemia, this is Fontaine stage III (ischaemic rest pain) and IV (ischaemic ulcers or gangrene) or Rutherford category 4 (ischaemic rest pain), 5 (minor tissue loss) or 6 (major tissue loss) \n\n Stenotic (>50% luminal loss) or occluded infrapopliteal artery, including the tibiofibular trunk, the anterior tibial artery, the posterior tibial artery and the peroneal artery, with a lesion length \u2264 60 mm \n\n Artery to be treated with a diameter more tham or equal to 2mm and less than or equal to 4mm \n\n Patent common iliac, external iliac, superficial femoral and popliteal artery on the ipsilateral side prior to randomisation, possibly after treatment during the same session \n\n At least one patent crural (anterior tibial, posterior tibial or peroneal) artery with expected unobstructed runoff to ankle level after treatment \n\n ", - "exclusion_criteria": ": \n\n Acute limb ischaemia \n\n Subacute limb ischaemia which requires thrombolysis as first treatment modality \n\n Active bleeding or bleeding diathesis \n\n Recent (less than 3 months) hemorrhagic stroke or other any other CNS abnormality with increased risk of haemorrhage, such as intracranial neoplasm, arteriovenous malformation, intracranial aneurysm or aneurysm repair \n\n Gastrointestinal or genitourinary bleeding of clinical significance within the previous 6 weeks before treatment \n\n Aneurysm in common femoral, superficial femoral or popliteal artery on the ipsilateral side \n\n Revascularization involving the same limb within 30 days prior to the index procedure or planned revascularization of the same limb within 30 days of the index procedure \n\n Previous implanted stent at the index site \n\n Life expectancy of less than 6 months or other factors making clinical follow-up difficult \n\n Known allergy to acetylsalicylic acid (aspirin), clopidogrel, heparin or paclitaxel \n\n Known allergy to contrast media \n\n Known heparin induced thrombocytopenia (HIT type 2) \n\n Patient unable or unwilling to tolerate anticoagulant, anti-platelet therapy or contrast media \n\n Creatinine clearance < 20 ml/min (as derived from Cockcroft-Gault or MDRD formula)unless patient is on hemodialysis \n\n Aneurysm in common femoral, superficial femoral or popliteal artery on the ipsilateral side \n\n Severely calcified lesions with expected resistance to stenting \n\n Poor inflow due to ipsilateral stenoses or occlusions of the iliac or femoropopliteal arteries that cannot be treated during the same session \n\n Significant vessel tortuosity or other parameters prohibiting access to the lesions and/or delivery of the stent \n\n Patients without (expected) distal runoff to the index site \n\n Previous implanted stent at the index site", - "brief_summary": "The purpose of this study is to investigate the performance of paclitaxel-coated balloon expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and occlusions in patients with critical limb ischemia compared to percutaneous transluminal balloon angioplasty (PTA).", - "NCTID": "NCT00471289" - }, - { - "brief_title": "Hyperspectral Imaging Pre and Post Endovascular Intervention", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Limb Ischemia', 'Non-Healing Ulcers']", - "diseases_list": [ - "Chronic Limb Ischemia", - "Non-Healing Ulcers" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with established diagnosis of lower limb ischemic based on their symptoms of claudication, rest pain, non-healing ulcers or gangrene and other vascular laboratory tests that are currently used to make this diagnosis and have been scheduled for endovascular revascularization. \n\n Age group between 50-85 \n\n Gender - Male or Female \n\n Race - all race and ethnicities \n\n ", - "exclusion_criteria": ": \n\n Patients with known cardiac disease - new MI (within 3 months). \n\n Patients with hypertension with the systolic BP >200 or diastolic BP>110 on the day of testing \n\n Patients on supplemental O2 for chronic obstructive lung disease \n\n Bed-ridden subjects - either due to chronic disability or neurological problems", - "brief_summary": "This trial will collect tissue oxygenation data via hyperspectral imaging before and after endovascular procedures.", - "NCTID": "NCT00768495" - }, - { - "brief_title": "Autologous Bone Marrow For Lower Extremity Ischemia Treating", - "phase": "Phase 2", - "drugs": "['Bone marrow aspiration, injection of cells', 'Bone marrow aspiration , injection of isolated CD 133+ cells', 'Bone marrow aspiration, injection of saline']", - "drugs_list": [ - "Bone marrow aspiration", - "injection of cells", - "Bone marrow aspiration ", - "injection of isolated CD 133+ cells", - "Bone marrow aspiration", - "injection of saline" - ], - "diseases": "['Lower Extremity Ischemia']", - "diseases_list": [ - "Lower Extremity Ischemia" - ], - "enrollment": "42.0", - "inclusion_criteria": "inclusion criteria: \n\n an obliterating lower extremity atherosclerosis IIB a stage (on Fontaine classification) \n\n a painless walking distance of 10-50 m \n\n pulse absence on \u0430\u0430. dorsalis pedis, tibialis posterior, poplitea \n\n absence of a ischemia in a rest and necrotic changes \n\n mainly distal form of disease (a lesion of a superficial femoral artery, a popliteal artery, anticnemion arteries) according to an angiography that testifies to impossibility of reconstructive operation performance \n\n patients after a lumbar sympathectomy and a tibial bone osteoperforations executed previously \n\n heavy smokers \n\n ", - "exclusion_criteria": ": \n\n insulin depended diabetes \n\n myocardial infarction or a stroke within last year \n\n an idiopathic hypertensia III stage \n\n anaemia and other diseases of blood \n\n decompensation of the chronic diseases which are contraindications to any surgical operation \n\n HIV infection \n\n a virus hepatitis \n\n oncologic diseases \n\n chemotherapy in the anamnesis", - "brief_summary": "The purpose of this study is to determine whether autologous bone marrow derived cells and isolated CD133+ fraction are effective in the treatment limb ischemia", - "NCTID": "NCT00753025" - }, - { - "brief_title": "Comparative Study of the Effects of Telmisartan and Nebivolol", - "phase": "Phase 4", - "drugs": "['TELMISARTAN', 'NEBIVOLOL']", - "drugs_list": [ - "TELMISARTAN", - "NEBIVOLOL" - ], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: The final selection of the sample of 80 patients diagnosed with stage I arterial hypertension will be based on the ABPM results (24h SBP/DBP \u2265 130/80 mm Hg). \n\n ", - "exclusion_criteria": ": \n\n Patients who present with normal ABPM values at the end of the 3-month period will be excluded from the study. Subjects diagnosed with white-coat hypertension [increased office BP values (SBP/DBP \u2265 140/90 mm Hg) combined with normal ABPM values (24h SBP/DBP < 130/80 mm Hg)] will also be excluded from the study. \n\n All subjects with contra-indications for submission of drugs used in the research protocol are going to be excluded from the study. The following categories of patients will not participate in the research: renal failure, hepatic failure, renal artery stenosis, bronchial asthma, vasoconstrictive (Prinzmetal's) angina, hypertrophic cardiomyopathy, aortic valve stenosis, mitral valve stenosis, sinus tachycardia, sinus bradycardia, sick sinus syndrome, Wolff-Parkinson-White syndrome, chronic atrial fibrillation, second and third degree atrioventricular block, right heart failure due to pulmonary hypertension, pheochromocytoma, peripheral artery disease. Pregnant and nursing women will be excluded from the study (history and pregnancy test).", - "brief_summary": "\u03a4he effectiveness of newer angiotensin-II receptor blockers and cardioselective beta-adrenergic blockers in treatment of arterial hypertension and in improvement of arterial stiffness has been established in previous studies among the hypertensive population. The present study is a comparison of the performance of two drugs, telmisartan and nebivolol, in 24h ambulatory blood pressure values and in the degree of arterial stiffness of patients with stage I arterial hypertension.~Measurements will be carried out with the use of 24-h ambulatory blood pressure measurement devices and the method of pulse-wave velocity analysis. The effects of telmisartan and nebivolol are going to be compared for a total time period of 12 months.~The aim of this project is to determine whether the expected decrease in arterial stiffness of subjects with stage I arterial hypertension can be attributed to the blood pressure fall solely, or to other factors as well. These factors are possibly dependent on the action of these drugs on the renin-angiotensin II-aldosterone system (RAAS) or on peripheral vasodilatory actions.~The present study is going to be the first comparative test of the anti-hypertensive effects of the two pharmaceutical substances in 12 months' time, and of the elimination of total cardiovascular risk in terms of primary prevention of cardiovascular attacks.", - "NCTID": "NCT02057328" - }, - { - "brief_title": "Efficacy and Safety of Valsartan Versus Amlodipine in Postmenopausal Women With Hypertension", - "phase": "Phase 4", - "drugs": "['Valsartan 320 mg', 'Amlodipine 10 mg', 'Hydrochlorothiazide']", - "drugs_list": [ - "Valsartan 320 mg", - "Amlodipine 10 mg", - "Hydrochlorothiazide" - ], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "125.0", - "inclusion_criteria": "inclusion criteria: \n\n Postmenopausal women \n\n Mild to moderate hypertension \n\n Statin therapy or LDL\u2264 4.1 mmol/L \n\n ", - "exclusion_criteria": ": \n\n Severe hypertension \n\n LDL > 4.1 mmol/L if not taking anti-hyperlipidemic medication \n\n Certain hormonal therapy \n\n History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm \n\n Liver, kidney, or pancreas disease \n\n Diabetes \n\n Raynaud's disease or any other significant peripheral vascular disease \n\n Allergy to certain medications used to treat high blood pressure \n\n Other protocol-defined inclusion/", - "brief_summary": "The purpose of this study is compare treatment with valsartan with the possible addition of a diuretic, hydrochlorothiazide, on high blood pressure with the drug amlodipine with the possible addition of a diuretic, hydrochlorothiazide. In particular, the effect of treatment on the stiffness of the blood vessels will be studied.", - "NCTID": "NCT00171054" - }, - { - "brief_title": "Comparison of Ticagrelor And Clopidogrel on Inflammatory Biomarkers And Vascular Endothelial Function", - "phase": "Phase 4", - "drugs": "['Ticagrelor', 'Clopidogrel']", - "drugs_list": [ - "Ticagrelor", - "Clopidogrel" - ], - "diseases": "['ST-Segment Elevation Myocardial Infarction']", - "diseases_list": [ - "ST-Segment Elevation Myocardial Infarction" - ], - "enrollment": "350.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or non-pregnant female. \n\n Age \u2265 18 years old and <80 years old. \n\n Consecutive patients who should be hospitalized with documented evidence of ST-Segment Elevation Myocardial Infarction receiving Percutaneous Coronary Intervention. \n\n All patients havepersistent\u22650.2 Millivolt ST segment elevation in two or more contiguous precordial leads or \u22650.1 Millivolt ST elevation in two or more contiguous limb leads, with one of the following: persistent chest pain or elevatory of biomarkers of myocardial necrosis. \n\n Time from chest pain onset to receiving Percutaneous Coronary Intervention <12 hours. \n\n Persistent chest pain <12 hours. \n\n Provision of informed consent prior to any study specific procedures. \n\n ", - "exclusion_criteria": ": \n\n Involved in other trials. \n\n In recent one year have P 2 Y 12 receptor antagonist drug treatment history or long-term use of immunosuppressive agents. \n\n Recurrent myocardial infarction or previous history of Coronary Artery Bypass Graft(CABG) surgery or rescue Percutaneous Coronary Intervention. \n\n Active bleeding or bleeding history. \n\n With obvious infection and body temperature (axillary temperature) higher than 38.0 \u2103. \n\n Autoimmune diseases. \n\n Malignancies. \n\n In recent 6 months have received major surgery. \n\n Left ventricular ejection fraction is less than 30%. \n\n Life expectancy less than one year. \n\n With moderate and severe liver function deterioration. \n\n End-stage renal failure. \n\n Other conditions that may put the patient at risk or influence study results in the investigators' opinion\uff1aeg, increased risk of bradycardiac events; known clinically important thrombocytopenia; known clinically important anemia; severe hemodynamic instability. \n\n Other contraindications to investigate products. \n\n Any condition that increases the risk for noncompliance or being lost to follow-up.", - "brief_summary": "Ticagrelor inhibits inflammation and improves vascular endothelial cell function to a greater extent than clopidogrel in ST-segment elevation myocardial infarction(STEMI) patients receiving percutaneous coronary intervention.~Ticagrelor can reduce the serum levels of inflammatory biomarkers both in coronary and in peripheral venous in patients with ST-segment elevation myocardial infarction(STEMI).", - "NCTID": "NCT02123004" - }, - { - "brief_title": "Neuromuscular Electrical Stimulation (NMES) in Patients With Intermittent Claudication", - "phase": "", - "drugs": "['Neuromuscular Electrical Stimulation']", - "drugs_list": [ - "Neuromuscular Electrical Stimulation" - ], - "diseases": "['Intermittent Claudication', 'Peripheral Vascular Disease']", - "diseases_list": [ - "Intermittent Claudication", - "Peripheral Vascular Disease" - ], - "enrollment": "21.0", - "inclusion_criteria": "inclusion criteria: \n\n All ethnic groups, male or female above the age of 18 years. \n\n Diagnosis of mild intermittent claudication \n\n Be of non-childbearing potential; OR using adequate contraception and have a negative urine pregnancy test result within 24 hours if appropriate before using the study device. \n\n Blood pressure currently under moderate control (< 160/100mmHg) \n\n No current foot ulceration \n\n ", - "exclusion_criteria": ": \n\n Patients meeting any of the following criteria are to be excluded: \n\n Has an unstable condition (eg, psychiatric disorder, a recent history of substance abuse) or otherwise thought to be unreliable or incapable of complying with the study protocol. \n\n Has diabetes \n\n Ankle Brachial Pressure Index > 0.9 \n\n Has any metal implants \n\n Pregnant \n\n Has a cardiac pacemaker or defibrillator device \n\n Has recent lower limb injury or lower back pain \n\n Has current foot ulceration or other skin ulcers \n\n Has foot deformities \n\n Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study.", - "brief_summary": "This study will assess the benefit of a neuromuscular electrical stimulation device in patients suffering from symptoms and effects of lower limb intermittent claudication.", - "NCTID": "NCT02436200" - }, - { - "brief_title": "Gene Therapy for Painful Diabetic Neuropathy", - "phase": "Phase 1; Phase 2", - "drugs": "['VM202']", - "drugs_list": [ - "VM202" - ], - "diseases": "['Painful Diabetic Neuropathy']", - "diseases_list": [ - "Painful Diabetic Neuropathy" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 18 years to 75 years \n\n Documented history of Type I or II diabetes with current treatment control (glycosylated hemoglobin A1c of \u2264 10.0%) \n\n Diagnosis of painful diabetic peripheral neuropathy in both lower extremities \n\n The physical examination component of the Michigan Neuropathy Screening Instrument Score (MNSI) is \u2265 3 at Screening \n\n Visual analog scale (VAS) score of \u2265 4 cm at Screening (0 cm = no pain - 10 cm worst imaginable pain) \n\n Stable treatment of diabetes for at least 3 months with no anticipated changes in medication regimen, and no new symptoms associated with diabetes \n\n Lower extremity pain for at least 6 months \n\n If female of childbearing potential, negative pregnancy test at screening and using acceptable method of birth control during the study. \n\n ", - "exclusion_criteria": ": \n\n Peripheral neuropathy caused by condition other than diabetes; \n\n Other pain more severe than neuropathic pain; \n\n Progressive or degenerative neurological disorder; \n\n Myopathy; \n\n Inflammatory disorder of the blood vessels (inflammatory angiopathy, such as Buerger's disease); \n\n Active infection; \n\n Chronic inflammatory disease (e.g. Crohn's, Rheumatoid Arthritis) \n\n Positive HIV or HTLV at Screening \n\n Positive Hepatitis B or C as determined by Hepatitis B core antibody (HBcAB), antibody to Hepatitis B antigen (IgG and IgM; HbsAB), Hepatitis B surface antigen (HBsAg) and Hepatitis C antibodies (Anti-HCV), at Screening or known immunosuppression or on chronic treatment with immunosuppressive drugs, chemotherapy or radiation therapy \n\n Stroke or myocardial infarction within last 6 months; \n\n Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that preclude standard ophthalmologic examination: \n\n Cataract surgery within 6 months of trial; \n\n Vascular lesions of the anterior segment of the eye (infection or ulceration of the cornea, rubeotic glaucoma, etc); \n\n Vascular lesions of the posterior segment of the eye or proliferative retinopathy, macular edema, s/p photocoagulation for macular edema or proliferative retinopathy; sickle cell retinopathy, ischemic retinopathy due to retinal venous stasis or carotid artery disease; \n\n Choroidal angiogenesis; and \n\n Large elevated choroidal nevi, choroidal vascular tumors (choroidal hemangioma), or melanomas. \n\n Specific laboratory values at Screening including: Hemoglobin < 9.0 g/dL, WBC < 3,000 cells per microliter, platelet count <75,000/mm3, Creatinine > 2.0 mg/dL; GFR < 50, AST and/or ALT > 2 times the upper limit of normal or any other clinically significant lab abnormality which in the opinion of the investigator should be exclusionary; \n\n Use of gamma-linolenic acid (GLA), alpha lipoic acid or any other high dose dietary antioxidant supplement for symptomatic relief of DPN; \n\n Uncontrolled hypertension as defined as sustained systolic blood pressure (SBP) > 200 mmHg or diastolic BP (DBP) > 110 mmHg at baseline/screening evaluation; \n\n Patients with history of or new screening finding of malignant neoplasm except basal cell carcinoma or squamous cell carcinoma of the skin (if excised and no evidence of recurrence); \n\n Malignant tumors or abnormal screening test suspicious for cancer, or patients in whom screening exams indicate possible occult malignancy unless malignancy has been ruled out. Patients with family history of colon cancer in any first degree relative unless they have undergone a colonoscopy in the last 12 months with negative findings; \n\n Elevated PSA unless prostate cancer has been excluded; \n\n Subjects requiring > 81 mg daily of acetylsalicylic acid; If > 81 mg are taken at screening, subjects may be enrolled if willing/able to switch to another medication; \n\n Major psychiatric disorder in past 6 months; \n\n History of drug or alcohol abuse / dependence in the past 2 years; \n\n History of recent tobacco abuse (within past 5 years); \n\n BMI > 38 kg/m2; \n\n Use of an investigational drug or treatment in past 12 months; and \n\n Unable or unwilling to give informed consent.", - "brief_summary": "The purpose of this study is to assess the safety and tolerability of injecting VM202 in the leg muscle in patients with painful diabetic neuropathy (DPN). The study will also assess the potential of VM202 to reduce the pain associated with DPN.", - "NCTID": "NCT01002235" - }, - { - "brief_title": "Difference Between Central and Peripheral Arterial Blood Oxygen Saturation With Different CPB Strategy", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Bypass Complications', 'Disorder of Blood Gas']", - "diseases_list": [ - "Bypass Complications", - "Disorder of Blood Gas" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n age > 18 years old \n\n undergoing totally thoracoscopic cardiac surgery with cardiopulmonary bypass \n\n ", - "exclusion_criteria": ": \n\n without informed consent \n\n pregnancy", - "brief_summary": "Femoro-femoral cardiopulmonary bypass with retrograde perfusion is needed for totally thoracoscopic cardiac surgery. one of the major complication of retrograde perfusion is organ hypoperfusion.~Arterial blood gas analysis can help to detect hypoperfusion or hypoxia during retrograde perfusion. However,whether the arterial oxygenation status from different parts of the body are the same in the condition of retrograde perfusion have not been studied.~The present study is aimed to determine if there is difference in the arterial oxygenation between peripheral arterial and aortic root during the period of retrograde perfusion.In addition, the impact of artificial ventilation on the difference of arterial oxygenation will also be investigated.", - "NCTID": "NCT01698853" - }, - { - "brief_title": "Ischaemic PReconditioning In Non Cardiac surgEry", - "phase": "", - "drugs": "['Remote ischemic preconditioning', 'no ischemic preconditioning']", - "drugs_list": [ - "Remote ischemic preconditioning", - "no ischemic preconditioning" - ], - "diseases": "['Myocardial Ischemia', 'Surgery']", - "diseases_list": [ - "Myocardial Ischemia", - "Surgery" - ], - "enrollment": "1100.0", - "inclusion_criteria": "inclusion criteria: \n\n written informed consent \n\n intermedial and high risk non cardiac surgery \n\n general anesthesia \n\n ongoing or recently suspended antiplatelet therapy \n\n ", - "exclusion_criteria": ": \n\n pregnancy \n\n planned locoregional anesthesia without general anesthesia \n\n unstable or ongoing angina \n\n recent (< 1 month) or ongoing acute myocardial infarction \n\n inclusion in other randomised controlled studies in the previous 30 days \n\n peripheral vascular disease affecting the upper limbs \n\n cardiac surgery", - "brief_summary": "Several randomized trials suggested a cardioprotective beneficial effect (eg reduction in cardiac troponin release) of remote ischemic preconditioning in cardiac surgery.~Remote ischemic preconditioning by brief episodes of ischemia and reperfusion in a remote organ or vascular territory provides protection from injury by myocardial ischemia and reperfusion. In the translation of remote ischemic preconditioning from bench to bedside, the first proof of principle and small randomized controlled trials have shown a decreased release of myocardial biomarkers after aortic, congenital cardiac, adult valve and coronary artery by-pass graft surgery. This reduction in cardiac biomarkers release translated into better survival in a recent randomized trial performed in cardiac surgery. No clinical trial on remote ischemic preconditioning in non-cardiac surgery setting has been performed so far.~The investigators study wants to test, for the first time, the hypothesis that remote ischaemic preconditioning is effective in reducing cardiac damage in high risk patients undergoing non-cardiac surgery. Remote ischaemic preconditioning will be achieved by inflation of a blood-pressure cuff to 200 mm Hg to the upper arm for 5 minutes, followed by 5 minutes reperfusion while the cuff will be deflated. General anesthesia will be induced and maintained without using propofol in both groups. Cardiac troponin will be used as marker of cardiac damage. If the results of a reduction in postoperative cardiac troponin release and perioperative cardiac ischaemic events will be confirmed in a non-cardiac surgery setting, the investigators could improve a strategy to prevent perioperative cardiac complication easy to apply, safe and low cost.", - "NCTID": "NCT02427867" - }, - { - "brief_title": "Safety and Tolerability of Azilsartan Medoxomil Plus Chlorthalidone Compared to Olmesartan Medoxomil Plus Hydrochlorothiazide in Participants With Essential Hypertension", - "phase": "Phase 3", - "drugs": "['Azilsartan medoxomil and chlorthalidone', 'Olmesartan medoxomil and hydrochlorothiazide']", - "drugs_list": [ - "Azilsartan medoxomil and chlorthalidone", - "Olmesartan medoxomil and hydrochlorothiazide" - ], - "diseases": "['Essential Hypertension']", - "diseases_list": [ - "Essential Hypertension" - ], - "enrollment": "837.0", - "inclusion_criteria": "inclusion criteria: \n\n Is treated with antihypertensive therapy and has a post-washout mean sitting clinic systolic blood pressure greater than or equal to 160 and less than or equal to 190 mm Hg on Day, or has not received antihypertensive treatment within 14 days prior to Screening and has a mean sitting clinic systolic blood pressure greater than or equal to 160 and less than or equal to 190 mm Hg at the Screening Visit and on Day 1. \n\n Females of childbearing potential who are sexually active agree to routinely use adequate contraception, and can neither be pregnant nor lactating from before study participation to Screening to 30 days after the last study drug dose. \n\n Has clinical laboratory test results within the reference range for the testing laboratory or the investigator does not consider the results to be clinically significant. \n\n Is willing to discontinue current antihypertensive medications up to 3 weeks before enrollment. \n\n ", - "exclusion_criteria": ": \n\n Has a mean clinic diastolic blood pressure (sitting, trough) greater than 119 mm Hg on Day 1. \n\n Has secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushing's syndrome). \n\n Has a recent history (within the last 6 months) of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack. \n\n Has clinically significant cardiac conduction defects (ie, third-degree atrioventricular block, sick sinus syndrome). \n\n Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease. \n\n Has severe renal dysfunction or disease. \n\n Has known or suspected unilateral or bilateral renal artery stenosis. \n\n Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. \n\n Has poorly-controlled type 1 or 2 diabetes mellitus at Screening. \n\n Has hypokalemia or hyperkalemia at Screening. \n\n Has an alanine aminotransferase or aspartate aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at Screening. \n\n Has any other known serious disease or condition that would compromise safety, might affect life expectancy, or make it difficult to successfully manage and follow according to the protocol. \n\n Has known hypersensitivity to angiotensin II receptor blockers or thiazide-type diuretics or other sulfonamide-derived compounds. \n\n Has been randomized/enrolled in a previous azilsartan or azilsartan medoxomil plus chlorthalidone study. \n\n Currently is participating in another investigational study or has received any investigational compound within 30 days prior to Screening. \n\n Has a history of drug abuse or a history of alcohol abuse within the past 2 years. \n\n Is taking or expected to take any excluded medication, including: \n\n Antihypertensive medications must be discontinued completely by Day -14, except antihypertensive medications used in the open-label treatment period in accordance with the titration-to-target blood pressure titration. \n\n Angiotensin II receptor blockers or thiazide-type diuretics other than study medication. \n\n Over-the-counter products not permitted by investigator.", - "brief_summary": "The purpose of this study is to compare the safety and tolerability of azilsartan medoxomil plus chlorthalidone, once daily (QD), versus olmesartan medoxomil-hydrochlorothiazide in adults with essential hypertension.", - "NCTID": "NCT00996281" - }, - { - "brief_title": "Osteoarthritis Cardiovascular Risk Factors", - "phase": "", - "drugs": "['Cardiovascular risk factors diagnoses collection.', 'History of cardiovascular disease', 'Cardiovascular risk factors association']", - "drugs_list": [ - "Cardiovascular risk factors diagnoses collection.", - "History of cardiovascular disease", - "Cardiovascular risk factors association" - ], - "diseases": "['Osteoarthritis', 'Cardiovascular Risk Factors', 'Cardiovascular Disease', 'Metabolic Syndrome']", - "diseases_list": [ - "Osteoarthritis", - "Cardiovascular Risk Factors", - "Cardiovascular Disease", - "Metabolic Syndrome" - ], - "enrollment": "490.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients referred for symptomatic hand or knee osteoarthritis \n\n All patients referred in the same period for soft tissue disease \n\n > 50 years old \n\n ", - "exclusion_criteria": ": \n\n Any other rheumatologic condition \n\n secondary osteoarthritis", - "brief_summary": "We analyze retrospectively the relationship between traditional cardiovascular risk factors as hypertension, obesity, dislipidemia and diabetes and hand or knee osteoarthritis and we compare the results with a control groups of patients with soft tissue disease with no other rheumatologic condition.", - "NCTID": "NCT01902654" - }, - { - "brief_title": "Agreement Between Arterial, Central Venous, and Peripheral Venous Lactate in the Intensive Care Unit", - "phase": "", - "drugs": "['Blood Lactate Analysis']", - "drugs_list": [ - "Blood Lactate Analysis" - ], - "diseases": "['Blood Lactate Analysis']", - "diseases_list": [ - "Blood Lactate Analysis" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult patients 18 years or older \n\n Admitted to the Intensive Care Unit (ICU) \n\n Determined by their treating clinicians to require both a central venous line and arterial line \n\n ", - "exclusion_criteria": ": \n\n None", - "brief_summary": "The main objective of this study is to examine the agreement between arterial, central venous, and peripheral venous lactate values in a population of medical Intensive Care Unit (ICU) patients.", - "NCTID": "NCT01624519" - }, - { - "brief_title": "Safety and Efficacy Study for the Treatment of Painful Diabetic Neuropathy", - "phase": "Phase 2", - "drugs": "['Low Dose: 16 mg VM202', 'High Dose: 32 mg VM202', 'Control- Placebo (normal saline)']", - "drugs_list": [ - "Low Dose: 16 mg VM202", - "High Dose: 32 mg VM202", - "Control- Placebo (normal saline)" - ], - "diseases": "['Painful Diabetic Neuropathies']", - "diseases_list": [ - "Painful Diabetic Neuropathies" - ], - "enrollment": "104.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 18 years to \u2264 75 years \n\n Documented history of Type I or II diabetes with current treatment control (glycosylated hemoglobin A1c of \u2264 10.0% at Screening) and currently on oral medication and/or insulin \n\n Diagnosis of painful diabetic peripheral neuropathy in both lower extremities \n\n Lower extremity pain for at least 6 months \n\n Visual analog scale (VAS) score of \u2265 40 mm at Initial Screening (0 mm = no pain - 100 mm very severe pain) \n\n Symptoms from the Brief Pain Neuropathy Screening (BPNS) is \u2264 5 point difference between legs at Initial Screening \n\n The average daily pain intensity score of the Daily Pain and Sleep Interference Diary completed after medication wash-out is \u2265 4 with a standard deviation \u2264 2 \n\n The physical examination component of the Michigan Neuropathy Screening Instrument Score (MNSI) is \u2265 3 at Screening \n\n Stable treatment of diabetes for at least 3 months with no anticipated changes in medication regimen, and no new symptoms associated with diabetes \n\n If female of childbearing potential, negative urine pregnancy test at screening and using acceptable method of birth control during the study \n\n ", - "exclusion_criteria": ": \n\n Peripheral neuropathy caused by condition other than diabetes \n\n Other pain more severe than neuropathic pain \n\n Progressive or degenerative neurological disorder \n\n Myopathy \n\n Inflammatory disorder of the blood vessels (inflammatory angiopathy, such as Buerger's disease) \n\n Active infection \n\n Chronic inflammatory disease (e.g., Crohn's disease, rheumatoid arthritis) \n\n Positive HIV or HTLV at Screening \n\n Active Hepatitis B or C as determined by Hepatitis B core antibody (HBcAB), antibody to Hepatitis B antigen (IgG and IgM; HbsAb), Hepatitis B surface antigen (HBsAg) and Hepatitis C antibodies (Anti-HCV) at Screening \n\n Subjects with known immunosuppression or currently receiving immunosuppressive drugs, chemotherapy or radiation therapy \n\n Stroke or myocardial infarction within last 3 months \n\n Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that preclude standard ophthalmologic examination \n\n Specific laboratory values at Screening including: Hemoglobin < 8.0 g/dL, WBC < 3,000 cells per microliter, platelet count <75,000/mm3, Creatinine > 2.0 mg/dL; AST and/or ALT > 3 times the upper limit of normal or any other clinically significant lab abnormality which in the opinion of the investigator should be exclusionary \n\n Uncontrolled hypertension as defined as sustained systolic blood pressure (SBP) > 200 mmHg or diastolic BP (DBP) > 110 mmHg at Screening \n\n Patients with a recent history (< 5 years) of or new screening finding of malignant neoplasm except basal cell carcinoma or squamous cell carcinoma of the skin (if excised and no evidence of recurrence); patients with family history of colon cancer in any first degree relative are excluded unless they have undergone a colonoscopy in the last 12 months with negative findings \n\n Subjects requiring > 81 mg daily of acetylsalicylic acid; If \u2265 81 mg are taken at screening, subjects may be enrolled if willing/able to switch to another medication \n\n Use of any opioids; subjects may be enrolled if willing and able to discontinue use of these drugs 14 days prior to starting the 7 Day Daily Pain and Sleep Interference Diary and refrain from taking these drugs for the duration of the study \n\n Subjects requiring regular COX-2 inhibitor drug(s) or non-specific COX-1/COX-2 inhibiting drugs, or high dose steroids (excepting inhaled steroids).Subjects may be enrolled if willing/able to undergo medication wash-out prior to the first dosing and to refrain from taking these drugs for the duration of the study; \n\n Major psychiatric disorder in within last 6 months \n\n Body mass index (BMI) > 45 kg/m2 at Screening \n\n Any lower extremity amputation \n\n Use of an investigational drug or treatment in past 6 months \n\n Unable or unwilling to give informed consent", - "brief_summary": "The purpose of this study is to determine if VM202 is safe and effective in treating painful diabetic neuropathy.", - "NCTID": "NCT01475786" - }, - { - "brief_title": "Effect of Remote Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation", - "phase": "", - "drugs": "['remote ischaemic preconditioning']", - "drugs_list": [ - "remote ischaemic preconditioning" - ], - "diseases": "['Kidney Diseases', 'Kidney Failure, Chronic', 'Kidney Failure', 'Renal Insufficiency', 'Renal Insufficiency, Chronic', 'Urologic Diseases']", - "diseases_list": [ - "Kidney Diseases", - "Kidney Failure", - "Chronic", - "Kidney Failure", - "Renal Insufficiency", - "Renal Insufficiency", - "Chronic", - "Urologic Diseases" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject capable of giving written informed consent, with end-stage kidney disease, who is a suitable candidate for primary kidney transplantation \n\n Living donors \n\n Compatible ABO blood type \n\n PRA < 20% \n\n ", - "exclusion_criteria": ": \n\n Re-transplant patients \n\n Those with peripheral vascular disease affecting the lower limbs", - "brief_summary": "The purpose of this study was to investigate whether lower limb ischaemic preconditioning can improve renal function in patients undergoing living donor kidney transplantation", - "NCTID": "NCT01289548" - }, - { - "brief_title": "Blood Pressure Lowering of Aliskiren Hydrochlorothiazide (HCTZ) Versus Amlodipine in Stage 2 Hypertension in African Americans", - "phase": "Phase 4", - "drugs": "['Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks', 'Amlodipine: 8 weeks']", - "drugs_list": [ - "Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks", - "Amlodipine: 8 weeks" - ], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "332.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed. \n\n Men or women 18 years and older of African American background; self identified \n\n Patients with stage 2 hypertension. Patients must have a MSSBP \u2265 160 mmHg and < 200 mmHg at Visit 5 (randomization) \n\n ", - "exclusion_criteria": ": \n\n Office blood pressure measured by cuff (MSSBP \u2265 200 mmHg and/or MSDBP \u2265 110 mmHg) at any visit. \n\n Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives whichever is longer. \n\n History of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (CCBs or thiazide diuretics) as the study drugs. \n\n Long QT syndrome or QTc > 450 msec for males and > 470 msec for females at screening. \n\n History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. \n\n Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL) \n\n Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. \n\n Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation. \n\n Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL [and estradiol < 20 pg/mL] or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. \n\n History or evidence of a secondary form of hypertension. \n\n Known Keith-Wagener Grade III or IV hypertensive retinopathy. \n\n History of cerebrovascular accident, transient ischemic cerebral attack (TIA), heart failure (NYHA Class II-IV), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) in the last 12 months. \n\n Current angina pectoris requiring pharmacological therapy. \n\n Other protocol-defined inclusion/", - "brief_summary": "The purpose of the study is to evaluate the efficacy and safety of a fixed dose combination of aliskiren HCTZ versus amlodipine in African American patients with Stage 2 hypertension.", - "NCTID": "NCT00739596" - }, - { - "brief_title": "Study on the Cardioprotection and Humoral Mechanism of Limb Ischemia Preconditioning", - "phase": "", - "drugs": "['limb ischemia preconditioning']", - "drugs_list": [ - "limb ischemia preconditioning" - ], - "diseases": "['Ischemic Preconditioning']", - "diseases_list": [ - "Ischemic Preconditioning" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n healthy volunteers aging 20-30 years old \n\n no cardiac\uff0chepatic or renal\uff0cperipheral vascular diseases \n\n be willing to enter our study and sign an written informed consent \n\n ", - "exclusion_criteria": ": \n\n younger than 20 years old or older than 30 years old \n\n having cardiac\uff0chepatic or renal\uff0cperipheral vascular diseases \n\n refuse to enter our study or sign an written informed consent", - "brief_summary": "Numerous studies Have shown that limb ischemic preconditioning can protect vital organs (including the heart) from ischemia-reperfusion injury,which has a broad application prospect.But its mechanism is still unclear. Evidence showed that humoral mechanisms may play an important role. This study was carried out on the limb ischemic preconditioning in healthy volunteers, collected their serum at different time points before and after treatment,classified and identified the serum proteins during different periods of limb ischemic preconditioning,by using methods including high abundant protein removal,Two-dimensional electrophoresis chromatography and mass spectrometry,then analysed activation and synthesis of the proteins in order to search for the proteins or peptides whose synthesis was activated by ischemic preconditioning. This study will be the first systemic explore of the changes in serum proteins of limb ischemic preconditioning in human body,and lay theoretical basis for the clinical application of limb ischemic preconditioning and for further explore of its humoral mechanism,thus provide clues for searching for protein or peptide having protective effects for organs.", - "NCTID": "NCT01118000" - }, - { - "brief_title": "Risk Factors for Acquired Cardiovascular Disease in Adults With Congenital Heart Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Congenital Heart Disease']", - "diseases_list": [ - "Congenital Heart Disease" - ], - "enrollment": "178.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or Female over 18 years of age \n\n Moderate or Complex Congenital Heart Disease \n\n Willingness to Consent \n\n ", - "exclusion_criteria": ": \n\n Pregnancy \n\n Surgery within 6 months \n\n Unrepaired cyanotic heart disease \n\n Patients with Eisenmenger Syndrome physiology", - "brief_summary": "This research study is to determine the risk factors for acquired heart disease, in adults with congenital heart disease. This knowledge is important to develop and target ways to prevent or delay the onset of acquired heart disease in adults with congenital heart disease.", - "NCTID": "NCT02433990" - }, - { - "brief_title": "Cerebral Near Infrared Spectroscopy During Blood Sampling From a Peripheral Artery Catheter in Preterm Infants", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cerebral Oxygenation', 'Cerebral Blood Flow', 'Prematurity']", - "diseases_list": [ - "Cerebral Oxygenation", - "Cerebral Blood Flow", - "Prematurity" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Preterm infant (Gestational Age <37+0) \n\n Peripheral arterial catheter (ulnary or radial artery) \n\n ", - "exclusion_criteria": ": \n\n Complex organ malformation", - "brief_summary": "Preterm infants often need peripheral artery catheters for invasive blood pressure recording and to facilitate blood sampling. Near infrared spectroscopy is a method to evaluate cerebral oxygenation and as well as cerebral blood flow. Sampling procedures with identical sampling volumes are performed at a short (40 seconds) and a long (70 seconds) time intervall while changes of cerebral oxygenation are measured. The investigators hypothesise that slower sampling decrease changes in cerebral blood flow.", - "NCTID": "NCT00926770" - }, - { - "brief_title": "Phase 3 Gene Therapy for Painful Diabetic Neuropathy", - "phase": "Phase 3", - "drugs": "['Engensis (VM202)', 'placebo']", - "drugs_list": [ - "Engensis (VM202)", - "placebo" - ], - "diseases": "['Painful Diabetic Neuropathy', 'Diabetic Neuropathy, Painful']", - "diseases_list": [ - "Painful Diabetic Neuropathy", - "Diabetic Neuropathy", - "Painful" - ], - "enrollment": "507.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 18 years to \u2264 75 years \n\n Documented history of type I or II diabetes with current treatment control (HbA1c of \u2264 10.0% at Screening) and currently on medication for diabetes (oral, injectable, and/or insulin) \n\n No significant changes anticipated in diabetes medication regimen \n\n No new symptoms associated with diabetes within the last 3 months prior to study entry \n\n Diagnosis of painful diabetic peripheral neuropathy in both lower extremities \n\n Lower extremity pain for at least 6 months \n\n Visual analog scale (VAS) score of \u2265 40 mm at Initial Screening (0 mm = no pain - 100 mm very severe pain) \n\n Symptoms from the Brief Pain Neuropathy Screening (BPNS) is \u2264 5 point difference between legs at Initial Screening \n\n The average daily pain intensity score of the Daily Pain and Sleep Interference Diary completed after medication wash-out is \u2265 4 with a standard deviation \u2264 2 \n\n The physical examination component of the Michigan Neuropathy Screening Instrument Score (MNSI) is \u2265 3 at Screening \n\n Subjects on gabapentin (Neurontin), pregabalin (Lyrica), duloxetine (Cymbalta) for painful DPN at study entry must be on stable regimen of these treatments for at least 3 months prior to study entry \n\n If female of childbearing potential, negative urine pregnancy test at screening and using acceptable method of birth control during the study \n\n ", - "exclusion_criteria": ": \n\n Peripheral neuropathy caused by condition other than diabetes \n\n Other pain more severe than neuropathic pain that would prevent assessment of DPN \n\n Progressive or degenerative neurological disorder \n\n Myopathy \n\n Inflammatory disorder of the blood vessels (inflammatory angiopathy, such as Buerger's disease) \n\n Active infection \n\n Chronic inflammatory disease (e.g., Crohn's disease, rheumatoid arthritis) \n\n Positive HIV or HTLV at Screening \n\n Active Hepatitis B or C as determined by Hepatitis B core antibody (HBcAb), antibody to Hepatitis B surface antigen (IgG and IgM; HBsAb), Hepatitis B surface antigen (HBsAg), and Hepatitis C antibodies (Anti HCV) at Screening \n\n Subjects with known immunosuppression or currently receiving immunosuppressive drugs, chemotherapy, or radiation therapy \n\n Stroke or myocardial infarction within last 3 months \n\n Specific laboratory values at Screening including: Hemoglobin < 8.0 g/dL, WBC < 3,000 cells per microliter, platelet count <75,000/mm3, Creatinine > 2.0 mg/dL; AST and/or ALT > 3 times the upper limit of normal or any other clinically significant lab abnormality which in the opinion of the investigator should be exclusionary \n\n Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that preclude standard ophthalmologic examination \n\n Uncontrolled hypertension defined as sustained systolic blood pressure (SBP) > 200 mmHg or diastolic BP (DBP) > 110 mmHg at Screening \n\n Subjects with a recent history (< 5 years) of or new screening finding of malignant neoplasm except basal cell carcinoma or squamous cell carcinoma of the skin (if excised and no evidence of recurrence for one year); subjects with family history of colon cancer in any first degree relative are excluded unless they have undergone a colonoscopy in the last 12 months with negative findings \n\n Use of the following drugs / therapeutics is prohibited. Subjects may participate in the study if they are willing to discontinue use of these drugs / therapeutics 7 days prior to starting the 7 Day Daily Pain and Sleep Interference Diary. Subjects must refrain from taking these drugs or undergoing these therapies for the duration of the study \n\n skeletal muscle relaxants, opioids, benzodiazepines (except for stable bedtime dose), \n\n capsaicin, local anesthetic creams (except for lidocaine cream prior to IM injection) and patches, isosorbide dinitrate (ISDN) spray, \n\n transcutaneous electrical nerve stimulation (TENS), acupuncture \n\n If not using gabapentin (Neurontin) or pregabalin (Lyrica), subjects must agree not to start these drugs for the first 180 days of the study. Subjects on these medications at study entry must maintain a stable dose until Day 180 of the study; \n\n If not using duloxetine (Cymbalta), any antidepressants (e.g., amitriptyline and venlafaxine), any other antiepileptics (e.g., valproic acid, carbamazepine, vigabatrin), subjects must agree not to start these drugs for the first 6 months of the study. \n\n Subjects on these medications at study entry must maintain a stable dose until Day 180 of the study \n\n Subjects requiring > 81 mg daily of acetylsalicylic acid; subjects may be enrolled if willing/able to switch to \u2264 81 mg daily of acetylsalicylic acid or to another medication \n\n Subjects requiring regular COX-2 inhibitor drug(s) or non-specific COX-1/COX-2 inhibiting drugs, or high dose steroids (except inhaled steroids or ocular steroids) subjects may be enrolled if willing/able to undergo medication wash-out prior to the first dosing and to refrain from taking these drugs until Day 180 of the study \n\n Major psychiatric disorder within the last 180 days that would interfere with study participation \n\n Body mass index (BMI) > 45 kg/m2 at Screening \n\n Any lower extremity amputation due to diabetic complications \n\n Use of an investigational drug or treatment in past 6 months, or prior participation in any study of Engensis (VM202) \n\n Unable or unwilling to give informed consent", - "brief_summary": "The purpose of this study is to determine the safety and efficacy of bilateral intramuscular injections of VM202 versus placebo in the treatment of painful diabetic peripheral neuropathy.~A total of 507 of 477 planned participants were randomized in a 2:1 ratio to one of two treatment groups. Note that 500 participants received IP treatment, whereas 7 participants did not receive IP treatment.~Treatments - Engensis (VM202) - 336 Engensis of 318 planned participants~Control - Placebo (VM202 vehicle) - 164 Placebo of 159 planned participants~Randomization were stratified by current use of gabapentin and/or pregabalin.", - "NCTID": "NCT02427464" - }, - { - "brief_title": "African American Community Health Project on Cardiovascular Disease", - "phase": "Phase 1", - "drugs": "['lecture']", - "drugs_list": [ - "lecture" - ], - "diseases": "['Cardiovascular Diseases', 'Cardiovascular Risk Factor']", - "diseases_list": [ - "Cardiovascular Diseases", - "Cardiovascular Risk Factor" - ], - "enrollment": "45.0", - "inclusion_criteria": "inclusion criteria: \n\n African American adults > 18 years old", - "exclusion_criteria": "", - "brief_summary": "The investigators seek to demonstrate that interactive physician-led education through partnership with an African American church will improve awareness and knowledge of cardiovascular disease in the African American community and will result in objective improvement in major risk factors associated with cardiovascular disease (CVD).", - "NCTID": "NCT01335022" - }, - { - "brief_title": "Can Remote Ischaemic Preconditioning Reduce Contrast Induced Nephropathy in Patients Receiving Contrast for Computed Tomography?", - "phase": "", - "drugs": "['Remote ischaemic preconditioning']", - "drugs_list": [ - "Remote ischaemic preconditioning" - ], - "diseases": "['Contrast Induced Nephropathy', 'Remote Ischaemic Preconditioning']", - "diseases_list": [ - "Contrast Induced Nephropathy", - "Remote Ischaemic Preconditioning" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Hospital inpatients undergoing contrast enhanced abdomino-pelvic CT scanning. \n\n ", - "exclusion_criteria": ": \n\n Those with an allergy/hypersensitivity to the contrast solution \n\n Those with a Cr of above 150\u03bcmol/dL on admission, as is a contraindication to IV contrast. \n\n Patients who are not getting IV contrast \n\n Any patients with a history of renal transplantation \n\n Any patients with a history of previous acute kidney injury necessitating management by a nephrologist \n\n Patients taking either a sulphonlurea or nicorandil.", - "brief_summary": "Computated tomography (CT) is an invaluable medical resource for both physicians and surgeons. Contrast media are an aid to improve the diagnostic yield of CT. While an incredibly powerful means of imaging the human body, there are possible complications to the use of contrast including a hypersensitive response and contract induced nephropathy (CIN). The latter will typically occur 48-72 hours after administration.~One recent meta - analysis of serum creatinine levels following contrast enhanced CT found 6.4% of those undergoing this investigation developed CIN. Although typically transient, 1 % had a persisting reduced renal function, with a small minority needing renal replacement therapy (RRT). The development of CIN was influenced by co morbidities and by the amount of contrast given.~The mechanism of injury to the kidney is not definitively established, but is thought most likely due to hypoxia resulting from reduced blood flow, thereby giving rise to oxygen free radicals causing direct damage to the kidney and also direct tubular damage.~Remote conditioning ischaemia has been hypothesized to be nephroprotective, whereby induced transient ischaemia at another site could buffer the impact of the contrast medium's effects. This was first demonstrated during cardiac angiograms, with those patients whom received multiple balloon inflations in the coronary arteries were found to have a lower incidence of CIN than those with fewer balloon inflations. Thus it could be hypothesised that any ischaemia temporarily induced could be nephroprotective. This can be at a point of extremity, rather than involving central organs, such as the arm, with ischaemia induced by the use of a blood pressure cuff, inflated to above systolic blood pressure levels.~No studies have been found in the literature attempting to demonstrate this effect in relation to contrast CT studies. Consequently, a randomised control clinical trial of patients to assess the effectiveness of remote ischaemic preconditioning is proposed.~Study Hypothesis: That performing remote ischaemic preconditioning on those undergoing CTs involving IV contrast is nephroprotective.", - "NCTID": "NCT01741896" - }, - { - "brief_title": "Assessment of the Safety and Efficacy of DERMASTREAM\u2122 - ENZYSTREAM\u2122 System for the Treatment of Chronic Venous Ulcers", - "phase": "Phase 1; Phase 2", - "drugs": "['Papain', 'Papain', 'Papain']", - "drugs_list": [ - "Papain", - "Papain", - "Papain" - ], - "diseases": "['Lower Extremity Chronic Venous Ulcers']", - "diseases_list": [ - "Lower Extremity Chronic Venous Ulcers" - ], - "enrollment": "48.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient must have a venous leg ulcer \n\n Participants, either men or women are between 18 and 85 years of age. \n\n Clinical presentation of venous insufficiency demonstrated by Doppler \n\n Ankle-Brachial Index > 0.7 by Doppler \n\n Good palpable pulses in the Posterior Tibial and the Dorsalis Pedis arteries. \n\n Wound present for at least 6 weeks prior to enrolment. \n\n Wound length is in the range of: 1.5 - 7 centimeters. \n\n The necrotic tissue area is at least 20% of wound area. (by clinical evaluation, i.e., inspection). \n\n Wound San Antonio classification: Grade 1 or 2, Stage A or B. \n\n Wound location: foot or calf, at a location where the device can be attached properly. \n\n Participant understands the nature of the procedure and provides written informed consent prior to any study procedure. \n\n Women of child bearing potential must use adequate birth-control precautions. \n\n ", - "exclusion_criteria": ": \n\n Documented sensitivity to Papain, by medical history records. \n\n Patients in need of surgical debridement. \n\n Patients with general skin disorders (Psoriasis, Peniculitis ect) that might deteriorate as a result of local trauma. \n\n Patients with skin disorders unrelated to the ulcer that are presented adjacent to the wound. \n\n Pain sensation is completely absent (wound area is anesthetic). \n\n Patients with renal failure. (Cr > 2 mg/dl). \n\n Patients with impaired hepatic function (ALT, AST or GGT 2-fold higher than normal upper limit value). \n\n Patients having Hypoalbuminemia: (Albumin < 2gr/dl ). \n\n Patients with general Immunological disorders that might deteriorate as a result of local trauma. \n\n Right-side congestive heart failure (CHF) with edema of legs: (NYHA class 2 or higher see APPENDIX 5). \n\n Participation in another clinical trial within 1 month prior to start of this study. \n\n Subject unwilling or unable to comply with the requirements of the protocol", - "brief_summary": "The study objectives are to evaluate DermastreamTM - EnzystreamTM system safety, tolerability and efficacy, as a potent method for debridement of nonhealing lower extremity chronic venous ulcers patients.", - "NCTID": "NCT00485329" - }, - { - "brief_title": "Evaluation of DermStream(tm) - an Irrigation Product for Chronic Wound Management", - "phase": "Phase 1; Phase 2", - "drugs": "['DermaStream(tm) application and Streaming of Saline']", - "drugs_list": [ - "DermaStream(tm) application and Streaming of Saline" - ], - "diseases": "['Venous Insufficiency', 'Diabetes']", - "diseases_list": [ - "Venous Insufficiency", - "Diabetes" - ], - "enrollment": "11.0", - "inclusion_criteria": "inclusion criteria: \n\n Diabetic ulcer, OR Venous insufficiency ulcer \n\n Age range: 18-80 years \n\n Wound max. diameter range: 1.5 - 10 centimeters \n\n Wound San Antonio assessment system: grade 1 and 2, stage A and B \n\n Palpable pulses in the Posterior Tibial and the Dorsalis Pedis arteries \n\n Ankle-Brachial Index > 0.7 by Doppler \n\n Wound present for at least 6 weeks \n\n Wound location: foot or calf, at a location where the device can be attached properly \n\n Lack of purulent discharge from the wound. \n\n ", - "exclusion_criteria": ": \n\n Hypoalbuminemia: Albumin < 2gr/dl \n\n Right-side congestive heart failure with edema of legs: +2 or higher \n\n Renal insufficiency: Cr > 2 mg/dl \n\n Abnormal liver function: ALT or AST>300 \n\n Skin disorders adjacent to the wound, unrelated to the pathology of the wound \n\n Non-cooperative patient", - "brief_summary": "The primary purpose of this study is to evaluate the safety of DermaStream(tm) in the management of chronic wounds.~Other goals of this study are to gain feedback from patients and healthcare providers on the ease of use (the ergonomic aspect) of the device, and to make a preliminary evaluation of the efficacy of DermaStream(tm) in chronic wound management.", - "NCTID": "NCT00310752" - } - ], - "1": [ - { - "brief_title": "Swedish Drug-elution Trial in Peripheral Arterial Disease", - "phase": "", - "drugs": "['Revascularization with drug-eluting technology', 'Revascularization without drug-eluting technology', 'drug-coated balloons and/or drug-eluting stents']", - "drugs_list": [ - "Revascularization with drug-eluting technology", - "Revascularization without drug-eluting technology", - "drug-coated balloons and/or drug-eluting stents" - ], - "diseases": "['Peripheral Arterial Disease', 'Critical Limb Ischemia', 'Intermittent Claudication']", - "diseases_list": [ - "Peripheral Arterial Disease", - "Critical Limb Ischemia", - "Intermittent Claudication" - ], - "enrollment": "3800.0", - "inclusion_criteria": "inclusion criteria: \n\n All adults > 18 years old willing to be randomized \n\n Symptomatic PAD (critical limb ischemia or intermittent claudication) caused by >50% stenosis or occlusion of infrainguinal arteries and eligible for endovascular treatment according to established indications \n\n ", - "exclusion_criteria": ": \n\n Acute thromboembolic disease in the leg \n\n Infrainguinal aneurysmal disease \n\n Previous participation in the study or in other randomised interventional study of infrainguinal lesions \n\n Patients without a Swedish personal identification number", - "brief_summary": "Peripheral arterial disease (PAD) causes reduced blood flow to the lower limb(s) due to stenosis or occlusion in the supplying arteries. Symptoms of PAD range from ischemic rest pain and/or ischemic ulcers/gangrene (critical limb ischemia), putting the extremity at risk of amputation, to exercise-induced pain (intermittent claudication), limiting the patients daily activities. Invasive treatments are often indicated to prevent amputations and to alleviate symptoms. More than two thirds of these procedures are presently performed with endovascular techniques (i.e. percutaneous transluminal angioplasty, PTA with or without stent implantation).~In coronary artery disease, stents eluting anti-proliferative drugs (drug eluting stents, DES) reduce restenosis and improve clinical results for the majority of patients. Drug eluting balloons (DEB) are a promising alternative, but there is still little evidence that DES or DEB technology improve clinical outcome in PAD. However, promising results utilizing these new technologies in PAD have been reported in a few studies.~In this trial, we test the hypothesis that drug eluting (DE) technology is superior to conventional endovascular treatment (no-DE) in terms of important clinical outcomes, when applied on infrainguinal (femoropopliteal and/or infrapopliteal) obstructive vascular lesions. The trial consists of 2 separate parallel studies, SWEDEPAD 1 and SWEDEPAD 2, each defined by the severity of peripheral arterial disease. Patients with critical limb ischemia are allocated to SWEDEPAD 1 and patients with intermittent claudication are allocated to SWEDEPAD 2.", - "NCTID": "NCT02051088" - }, - { - "brief_title": "Exercise Therapy With Risk Factor Management and Life Style Coaching After Vascular Intervention for Patients With Peripheral Arterial Disease", - "phase": "", - "drugs": "['Supervised Exercise Therapy']", - "drugs_list": [ - "Supervised Exercise Therapy" - ], - "diseases": "['Peripheral Arterial Disease, Rutherford 4 and 5 With Possibility to Improve Vascularization']", - "diseases_list": [ - "Peripheral Arterial Disease", - "Rutherford 4 and 5 With Possibility to Improve Vascularization" - ], - "enrollment": "14.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with peripheral arterial disease Rutherford stage 4 and 5, where it is possible to improve the vascularization of the affected leg with the help of an endovascular and / or open surgical vascular intervention. \n\n Patients with both legs are affected, but the most severe leg does not exceed stage 5. \n\n ", - "exclusion_criteria": ": \n\n Severe cardiopulmonary comorbidity (NYHA 4) and previous amputations of lower leg or thigh. \n\n Patients with limited amputation of the toes can participate. \n\n Insufficient understanding of the Dutch language. \n\n No physiotherapy insurance.", - "brief_summary": "Patients with peripheral arterial disease with symptoms of critical ischemia or reduced tissue loss have a very high mortality and morbidity rate. So far, treatment strategies focused on the preservation of life and limb by an open surgical or endovascular revascularization, together with cardiovascular risk management and pain relief. Important modifiable factors related to mortality and morbidity are not covered in the current national and international guidelines. This study investigates the effects on mobility, mortality and quality of life with supplementation of the standard treatment of critical limb ischemia with supervised exercise therapy. Also a reduction of cardiovascular risk by intensive risk factor management and lifestyle coaching will be taken in to account. The supervised exercise therapy will take place under the supervision of a trained physiotherapist.", - "NCTID": "NCT02110251" - }, - { - "brief_title": "Mechanisms That Produce the Leg Dysfunction of Claudication (Leg Pain and Limping During Walking) and Treatment Strategies for the Care of Patients With Claudication", - "phase": "", - "drugs": "['Revascularization Surgery', 'Supervised exercise therapy']", - "drugs_list": [ - "Revascularization Surgery", - "Supervised exercise therapy" - ], - "diseases": "['Peripheral Arterial Disease']", - "diseases_list": [ - "Peripheral Arterial Disease" - ], - "enrollment": "220.0", - "inclusion_criteria": "inclusion criteria: \n\n a positive history of chronic claudication \n\n exercise-limiting claudication established by history and direct observation during a screening walking test administered by the evaluating vascular surgeon \n\n an ankle/brachial index < 0.90 at rest \n\n ", - "exclusion_criteria": ": \n\n absence of Peripheral Arterial Disease (PAD) \n\n acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma \n\n exercise capacity limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology", - "brief_summary": "Intermittent claudication afflicts 5% of the US population older than 55 years of age and develops along with hardening of the arteries of the legs. Claudicating patients limp and can only walk very short distances because their legs hurt. This protocol evaluates the mechanisms that may produce the leg dysfunction of claudication and its successful completion can ultimately produce significant new diagnostic and treatment strategies for the care of claudicating patients.", - "NCTID": "NCT01970332" - }, - { - "brief_title": "Long-term Pleiotropic Effect of Statins in Patients With Peripheral Arterial Disease", - "phase": "Phase 4", - "drugs": "['Atorvastatin', 'Standard Medical Treatment']", - "drugs_list": [ - "Atorvastatin", - "Standard Medical Treatment" - ], - "diseases": "['Peripheral Arterial Disease']", - "diseases_list": [ - "Peripheral Arterial Disease" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n patients at the time of diagnosis of Fontaine grade II peripheral arterial disease (PAD), confirmed by hemodynamic evaluation (Doppler ultrasound) \n\n over 18 years old \n\n ", - "exclusion_criteria": ": \n\n patients had previously undergone revascularization \n\n patients were receiving treatment with statins \n\n patients with contraindications to statin use. \n\n patients with coexistence of chronic inflammatory diseases or steroidal medication", - "brief_summary": "The purpose of this study is to determine the long-term effects of statins, atorvastatin, upon Nitric Oxide, as an endothelial function assessment, and C-Reactive Protein, an inflammatory marker, levels in patients with Peripheral Arterial Disease. These long-term biological pleiotropic effects of statins will offer information on the role of endothelial function and systemic inflammation in the etiopathogenesis of PAD.", - "NCTID": "NCT01041729" - }, - { - "brief_title": "Effects of Canola Oil on Blood Vessel Function in Peripheral Arterial Disease", - "phase": "", - "drugs": "['traditional canola oil', 'high oleic canola oil', 'soybean oil', 'high linoleic safflower oil', 'coconut oil', 'traditional canola oil', 'safflower oil']", - "drugs_list": [ - "traditional canola oil", - "high oleic canola oil", - "soybean oil", - "high linoleic safflower oil", - "coconut oil", - "traditional canola oil", - "safflower oil" - ], - "diseases": "['Peripheral Arterial Disease']", - "diseases_list": [ - "Peripheral Arterial Disease" - ], - "enrollment": "53.0", - "inclusion_criteria": "inclusion criteria:Healthy age-matched participants (acute phase of the study): \n\n Healthy volunteers, male or female, > 40 years of age; \n\n Body Mass Index 18-30; \n\n Glycated hemoglobin <6.5%; \n\n Fasting serum total cholesterol <4 mmol/L and triglycerides <2.5 mmol/L; \n\n Blood pressure <140/90 mm Hg; \n\n Ankle-brachial index of >0.9; \n\n Willing to comply with the protocol requirements; \n\n Willing to provide informed consent; \n\n Participants having completed another food-related study are eligible to participate if it has been more than 3 months since their participation. \n\n inclusion criteria, peripheral arterial disease participants (acute and chronic phases of the study): \n\n Male or female, > 40 years of age; \n\n Documented peripheral arterial disease including those with claudication as defined by an ankle brachial index of \u22640.90 or asymptomatic carotid stenosis of >50%; or who have had a previous intervention for peripheral arterial disease; \n\n Stable medication profile for the past 3 months with no changes anticipated for the duration of the acute or chronic phases; \n\n Willing to comply with the protocol requirements; \n\n Willing to provide informed consent; \n\n Participants having completed another food study are eligible to participate if it has been more than 3 months since the study was completed. \n\n ", - "exclusion_criteria": ", healthy age-matched participants (acute phase of the study): \n\n Currently smoking, or smoking within the last 6 months (Note: cigar smoking on an occasional basis will be permitted); \n\n Presence of a clinically diagnosed disease affecting the heart, liver, kidneys, lungs,gastrointestinal, endocrine or blood/immune systems that requires medical treatment; \n\n Taking any prescribed medication within the last 3 months with the exception of anti-depressants, birth control and hormone (estrogen) replacement therapy; \n\n Pregnancy; \n\n Amputation of upper or lower extremity on both sides; \n\n Has undergone a surgical procedure requiring local or general anesthetic within the last 3 months; \n\n History of gastrointestinal reactions or allergies to dietary oils and other ingredients in banana bread such as wheat and eggs; \n\n Daily consumption of omega-3 supplements. \n\n ", - "brief_summary": "The fatty acid composition of canola oil will have beneficial acute and chronic effects on vascular function in individuals with peripheral arterial disease.", - "NCTID": "NCT01250275" - }, - { - "brief_title": "Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities", - "phase": "Phase 3", - "drugs": "['Clopidogrel', 'Acetylsalicylic acid (ASA)']", - "drugs_list": [ - "Clopidogrel", - "Acetylsalicylic acid (ASA)" - ], - "diseases": "['Peripheral Arterial Disease']", - "diseases_list": [ - "Peripheral Arterial Disease" - ], - "enrollment": "159.0", - "inclusion_criteria": "inclusion criteria: \n\n General: \n\n Signed informed consent \n\n At least 18 years old \n\n Documented symptomatic iliac, femoropopliteal (FP) or below-the knee artery (BTK) atherosclerotic disease (Rutherford/Becker category 2, 3 or \u22654) \n\n Undergone clinically indicated uncomplicated endovascular intervention to one or more locations of the iliac, femoropopliteal below-the knee arteries \n\n Estimated survival \u22651 year in the judgment of the primary operator \n\n Pre-index procedure use of ASA, clopidogrel or both at any dose \n\n Angiographic: \n\n De novo or restenotic lesions in the common and/or external iliac artery, superficial femoral artery (SFA), popliteal artery, tibio-peroneal (TP) trunk, anterior tibial (AT) artery, peroneal artery (PA) or posterior tibial (PT) artery (applies to all target lesions if multiple) \n\n Subjects with multiple planned procedures can be enrolled after the completion of the last planned procedure. \n\n ", - "exclusion_criteria": ": \n\n General: \n\n Complicated qualifying procedure (perforation, flow limiting dissection, distal embolization requiring re-intervention, need for repeat endovascular, surgical revascularization, amputation or blood transfusion prior to hospital discharge following an index procedure \n\n Extended hospital stay >7 days following the index procedure \n\n Allergy to aspirin or clopidogrel \n\n Life expectancy less than 12 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the trial \n\n Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated. \n\n Intolerance to antiplatelet, anticoagulant, or thrombolytic medications \n\n Platelet count <90,000 mm3 or >600,000 mm3 \n\n Serum creatinine >2.5 mg/dL \n\n Dialysis-dependent end stage renal disease \n\n Pregnancy \n\n Current participation in another drug or device trial that requires interruption of dual-antiplatelet therapy with aspirin or clopidogrel for the duration of the study \n\n Planned surgeries, endovascular or other non-vascular or cardiac procedures \n\n Concurrent warfarin or other chronic oral anticoagulant therapy \n\n Contraindication(s) to the use of AT (history of intra-cerebral bleed, presence of intra-cerebral mass, recent or <6 weeks gastrointestinal bleed, blood transfusion within the last 6 weeks, any trauma requiring surgery or blood transfusion within the last 4 weeks or any surgical procedure within the last 4 weeks. \n\n Angiographic: \n\n Endovascular intervention to iliac, femoropopliteal or BTK artery bypass graft \n\n Persistent, intraluminal thrombus of the proposed target lesion at the completion of the index procedure \n\n Perforated vessel as evidenced by extravasation of contrast media \n\n Vascular graft, aneurysm or postsurgical stenosis of the target vessel", - "brief_summary": "The purpose of this study is to evaluate whether clopidogrel 75 mg daily on a background of aspirin 75-100 mg/d for clinically indicated duration or for an additional 12 months will lead to an increased rate of primary patency, limb salvage, non-fatal myocardial infarction (MI), ischemic stroke, and survival, in patients receiving endovascular treatment of PAD at end of study treatment.", - "NCTID": "NCT02217501" - }, - { - "brief_title": "Microparticles and the Risk of Re-stenosis Following Balloon Angioplasty in Patients With Peripheral Arterial Disease", - "phase": "", - "drugs": "['percutaneous transluminal angioplasty femoro-popliteal']", - "drugs_list": [ - "percutaneous transluminal angioplasty femoro-popliteal" - ], - "diseases": "['Peripheral Vascular Diseases']", - "diseases_list": [ - "Peripheral Vascular Diseases" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n male or female \n\n 60-85 years \n\n femoro-popliteal stenosis \n\n TASC B or C category \n\n HBA1c <9%, if diabetic \n\n creatinine <130\u00b5g/ml \n\n blood pressure <160/95mmHg \n\n thrombocyte aggregation inhibitors or coumarine derivatives \n\n ", - "exclusion_criteria": " \n\n <60 or >85 years \n\n stenosis not in femoro-popliteal axis \n\n TASC A or D category \n\n HBA1c >9%, if diabetic \n\n creatinine >130\u00b5g/ml \n\n blood pressure >160/95mmHg \n\n major trauma \n\n malignancy \n\n anti-phospholipid syndrome \n\n relevant hepatic disease \n\n major operation within 1 month of enrolment", - "brief_summary": "Although microparticles have been well-documented as mediators of inflammation and coagulation in various cardio-vascular disease events, it is currently not known how Percutaneous Transluminal Angioplasty (PTA) for peripheral arterial disease influences microparticle numbers, phenotype and distribution pre- and post interventionally and how they are related to or affect the incidence of early re-stenosis - or if indeed they may be used to predict patients at risk of early re-stenosis.", - "NCTID": "NCT01422343" - }, - { - "brief_title": "Evaluation of the Safety of Compressive Socks to Treat Venous Insufficiency in Patients With Peripheral Arterial Disease", - "phase": "", - "drugs": "['contention socks']", - "drugs_list": [ - "contention socks" - ], - "diseases": "['Peripheral Arterial Disease', 'Venous Insufficiency']", - "diseases_list": [ - "Peripheral Arterial Disease", - "Venous Insufficiency" - ], - "enrollment": "18.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient suffering from a PAD (systolic pressure index \u2265 0,60 and \u2264 0,75) and having moderate venous insufficiency or classified as C1s to C4 using the CEAP classification \n\n Age over 18 years \n\n French health insurance \n\n Signed informed consent \n\n ", - "exclusion_criteria": ": \n\n Hypertension not controlled or hypertensive crisis (risk of non reproducibility of SPI and TBI) \n\n Diabetes \n\n Mediacalcosis (SPI not computable) \n\n Inflammatory arterial diseases of the lower limb \n\n Permanent edema, lipedema and lymphedema \n\n Wound and fragile skin \n\n Phlegmatia coerulea dolens \n\n Septic thrombophlebitis \n\n Severe coronary artery disease \n\n Oozing and infectious skin diseases, skin ulcers \n\n Known hypersensitivity to components of the study compressive stockings", - "brief_summary": "Elastic compression stockings are recommended in the treatment venous insufficiency. Degressive compressive stockings have been used for many decades and are characterized by a high pressure applied at the ankle and a decreasing pressure from the ankle to the knee. Progressive compressive stockings were developed to have a maximal pressure at the calf. This concept is based on the calf pump role in the venous return. Patients with PAD (Peripheral Arterial Disease) often suffer from venous insufficiency. But elastic compression stockings are strictly contraindicated for patients with PAD because highest pressures on ankle could slow down the superficial microcirculation.~On patients with PAD and venous insufficiency, the progressive compressive stockings could be well indicated. Strongest pressure at the calf should increase the pump effect and the muscle mechanical efficiency during the walk without deleterious effect.", - "NCTID": "NCT02431819" - }, - { - "brief_title": "Study of SilverHawk\u00ae/TurboHawk\u00ae in Lower Extremity Vessels (DEFINITIVE\u2122 LE)", - "phase": "", - "drugs": "['SilverHawk & TurboHawk Peripheral Plaque Excision System']", - "drugs_list": [ - "SilverHawk & TurboHawk Peripheral Plaque Excision System" - ], - "diseases": "['Peripheral Arterial Disease', 'Claudication', 'Critical Limb Ischemia']", - "diseases_list": [ - "Peripheral Arterial Disease", - "Claudication", - "Critical Limb Ischemia" - ], - "enrollment": "800.0", - "inclusion_criteria": "inclusion criteria \n\n Has a Rutherford Clinical Category Score of 1 - 6. \n\n Has evidence of \u2265 50% stenosis or occlusion in the superficial femoral, popliteal, anterior tibial, posterior tibial and/or peroneal arteries, confirmed by angiography. \n\n Has identifiable distal target vessel which upon completion of the intervention, is anticipated to provide re-constitution of blood flow to the foot. \n\n Exchangeable guidewire must cross lesion(s), with ability of catheter to cross lesion. \n\n Each discrete target lesion's length is \u2264 20 cm. \n\n Reference vessel diameter is \u2265 1.5 mm and \u2264 7 mm. \n\n ", - "exclusion_criteria": " \n\n Has surgical or endovascular procedure of the target vessel within 14 days prior to the index procedure. \n\n Has any planned surgical intervention or endovascular procedure within 30 days after the index procedure. \n\n Has had a previous peripheral bypass affecting the target limb. \n\n Has end-stage renal disease defined as undergoing hemodialysis for kidney failure. \n\n Has presence of severe calcification in target lesion(s). \n\n Has in-stent restenosis of the target lesion. \n\n Has an aneurysmal target vessel. \n\n Has significant stenosis or occlusion of inflow tract that has not been revascularized prior to treatment of the target vessel. \n\n Has perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to enrollment. \n\n Has disease that precludes safe advancement of the SilverHawk/TurboHawk device to the target lesion(s). \n\n Has had a previous amputation above the metatarsal line on the target limb.", - "brief_summary": "The purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs.", - "NCTID": "NCT00883246" - }, - { - "brief_title": "Efficacy and Safety of Umbilical Cord Blood Injection for Critical Limb Ischemia", - "phase": "Phase 1", - "drugs": "['Cord blood stem cell injection']", - "drugs_list": [ - "Cord blood stem cell injection" - ], - "diseases": "['Critical Limb Ischemia']", - "diseases_list": [ - "Critical Limb Ischemia" - ], - "enrollment": "1.0", - "inclusion_criteria": "inclusion criteria: \n\n Atherosclerotic ischemic peripheral vascular disease or Thromboangiitis Obliterans with Critical Limb Ischemia (Fontaine stages III and IV) \n\n Participant must match either a or b \n\n Ankle brachial index (ABI) \u2264 0.7 \n\n Doppler waveforms at posterior tibial artery and dorsalis pedis artery are monophasic with toe pressure < 30 mmHg. \n\n A non-surgical candidate for revascularization e.g. prior vascular reconstruction, inability to locate a suitable vein for grafting, diffuse multi- segment disease, or extensive infra-popliteal disease not amenable to a vascular graft. \n\n Age > 18 years old. \n\n The non-index leg may be treated only in the event and it full fills the same eligibility criteria and ", - "exclusion_criteria": " used in this protocol for the treatment leg. \n\n Patients must be on maximal tolerated medical therapy for PVD including A) Cessation of smoking B) Referral to endocrinologist for control of HgA1c to < 7.0 mg/dl, control of hyperlipidemia with statins or other anti-hyperlipidemic drugs as indicated, control of hypertension as indicated C) Antiplatelet therapy with aspirin and / or cilostazol (unless medically contraindicated, e.g. bleeding or allergy) \n\n ", - "brief_summary": "The purpose of this study is to determine whether treatment with umbilical cord blood stem cells will improve blood flow to the most severely affected leg of a participant with medically refractory and non-surgical peripheral vascular disease of the lower extremity.", - "NCTID": "NCT01019681" - }, - { - "brief_title": "Effects of Remote Ischemic Preconditioning on Restenosis Post Lower Limb Revascularization Angioplasty", - "phase": "", - "drugs": "['Remote Ischemic Preconditioning']", - "drugs_list": [ - "Remote Ischemic Preconditioning" - ], - "diseases": "['Peripheral Vascular Diseases']", - "diseases_list": [ - "Peripheral Vascular Diseases" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria \n\n 1. Patients planned for lower limb Angioplasty \n\n ", - "exclusion_criteria": " \n\n Known upper limb PVD \n\n Previous history of upper limb deep vein thrombosis \n\n Patients on glibenclamide or nicorandil- May affect RIPC \n\n Raynaud's Disease \n\n Intra operative decision to use graft - will be documented", - "brief_summary": "The investigators will established relation between restenosis and inflammatory response to shearing stress caused by angioplasty suggest that any mechanism that affect inflammatory response can consequently affect the restenosis rate. There is accumulated evidence that remote ischemic precondition has modifying suppressive effect on inflammatory response and the investigators hypothesized that RIPC may lead to reduction in post angioplasty restenosis rate.", - "NCTID": "NCT02406131" - }, - { - "brief_title": "Phase II Study of Heart Polypill Safety and Efficacy in Primary Prevention of Cardiovascular Disease", - "phase": "Phase 2", - "drugs": "['Polypill', 'Placebo drug']", - "drugs_list": [ - "Polypill", - "Placebo drug" - ], - "diseases": "['Cardiovascular Disease', 'Hypertension', 'Hyperlipidemia', 'Heart Disease']", - "diseases_list": [ - "Cardiovascular Disease", - "Hypertension", - "Hyperlipidemia", - "Heart Disease" - ], - "enrollment": "475.0", - "inclusion_criteria": "inclusion criteria \n\n All men over 50 to 80 and all women 55 to 80 who are resident in Kalaleh, Golestan, for at least one year. \n\n ", - "exclusion_criteria": " \n\n Existing cardiovascular disease (stroke, transient ischaemic attack, myocardial infarction or angina) \n\n Already taking antihypertensive drugs, aspirin or statins \n\n Already have clinical indications for treatment with antihypertensive drugs, aspirin or statins. \n\n Blood pressure >160/100 mm Hg \n\n Total Cholesterol > 240 mg/dL (or LDL >190 mg/dL) \n\n Probable diabetes: HbA1c >6.0 \n\n Contraindication to a component of the Polypill \n\n Contraindications to aspirin \n\n Previous history of allergy to aspirin \n\n History of peptic ulcer bleeding in whole life or endoscopic evidence of peptic ulcer within the past 3 months \n\n Contraindications to statins \n\n Liver failure Contraindications to further blood pressure lowering \n\n Systolic blood pressure \u226490 mm Hg or diastolic blood pressure \u226470 mm Hg \n\n Symptomatic postural hypotension \n\n Difference between mean seated BP and standing BP greater than 20 mm Hg \n\n Contraindications to thiazide \n\n Uric acid >8 for men and uric acid >6 for women / gout ( \n\n 10%) \n\n Creatinine >1.2 mg/dl \n\n Other predominant medical problem that may limit compliance with study treatment including: \n\n History of alcohol abuse: more than 60cc for women and more than 80cc for men \n\n History of drug abuse: IV drug abuser or eating or smoking more than 4 times a week \n\n Limiting psychiatric illness (eg: mania, schizophrenia, severe depression, psychosis or dementia) \n\n Limiting physical disability sufficient to prevent subject from walking \n\n Other life-threatening condition such as cancer", - "brief_summary": "Cardiovascular is a major cause of mortality in Iran, accounting for 45.7% of deaths. In Golestan (North Eastern Iran) preliminary findings from follow-up of the Golestan Cohort are consistent with national figures: with 45% (at least 22 of 48 deaths) of all deaths attributed to cardiovascular events. Cardiovascular diseases will become an increasing problem as the Iranian population ages.~In 2003 Law and Wald proposed prevention of cardiovascular disease using fixed-dose combination therapy combining antihypertensive, lipid lowering and antiplatelet drugs in a single preparation. They proposed that this treatment should be offered to all persons at high risk of cardiovascular disease whether or not they have elevated blood pressure or elevated serum lipid concentrations.~This pilot study aims to investigate the safety and efficacy of fixed-dose combination therapy with two antihypertensive drugs, aspirin and atorvastatin in a population who would not currently be considered eligible for antihypertensive treatment or for lipid lowering treatment.~Methods:~This is a double-blind randomized controlled trial. The intervention group will be assigned to take a tablet consisting of a single daily tablet comprising Aspirin 81mg, Hydrochlorothiazide 12.5mg, Enalapril 2.5mg and Atorvastatin 20mg. The control group will be assigned to an identical placebo.~The population studied includes men aged 50 to 80 (inclusive) and women aged 55 to 80 (inclusive) who are currently not eligible for or taking antihypertensive or lipid lowering therapy. Persons who are found at baseline to have blood pressure >160/100 mm Hg, total cholesterol >240mg/dL, existing cardiovascular disease or to be taking antihypertensive ore lipid lowering therapy are excluded.~It is intended to randomize and follow up 500 subjects for 12 months. The primary outcome for the purpose of sample size calculation is change in systolic blood pressure. Additional outcomes include change in diastolic blood pressure, change in LDL cholesterol and occurrence of adverse events.", - "NCTID": "NCT00603590" - }, - { - "brief_title": "Use of Remote Ischaemic Preconditioning in the Prevention of Contrast Induced Nephropathy", - "phase": "", - "drugs": "['RIPC']", - "drugs_list": [ - "RIPC" - ], - "diseases": "['Remote Ischaemic Preconditioning', 'Contrast Induced Nephropathy']", - "diseases_list": [ - "Remote Ischaemic Preconditioning", - "Contrast Induced Nephropathy" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Elective intra-arterial peripheral angiography/angioplasty; \n\n Patients >21 years of age; \n\n Patients with CKD as evidenced by eGFR levels of 30ml/min < eGFR < 60ml/min (moderate risk) or eGFR levels of >= 60ml/min (low risk). \n\n ", - "exclusion_criteria": ": \n\n Severe renal impairment eGFR <30ml/min; \n\n Evidence of acute renal failure or patients on dialysis; \n\n History of previous CIN; \n\n Contraindication to volume replacement therapy; \n\n Pregnancy; \n\n Patients on glibenclamide or nicorandil (these medications may interfere with RIPC).", - "brief_summary": "With an increasingly ageing population the incidence of peripheral arterial disease (PAD) is rising. With approximately one quarter of all PAD patients ultimately progressing to Critical Limb Ischaemia (CLI), increased demands are being placed on vascular imaging to accurately assess stenotic lesions. Early infrainguinal lesions (i.e. TASC A & B) can be treated with angioplasty+/- stenting and accurate assessment relies on the imaging gold standard of angiography.~Patients with PAD often have concomitant co morbidities such as diabetes and chronic renal impairment placing them at increased risk of developing contrast induced nephropathy (CIN) when exposed to iodinated contrast media. High risk individuals with decreased eGFR <60ml/min have a risk of between 20-30% of developing CIN. They have increased morbidity and mortality risks with a greater need for dialysis and prolonged in patient hospital stays. Ideally, the investigators should be searching for ways to decrease the incidence of CIN. Animal studies and more recently pilot human trials have shown that subjecting a remote vascular bed to a brief ischaemic stress, followed by a period of reperfusion; in what has been termed remote ischemic preconditioning (RIPC), may confer a protective benefit against the development of CIN. This study aims to determine if RIPC can protect against CIN in patients undergoing elective peripheral angiography for infrainguinal disease.", - "NCTID": "NCT02516072" - }, - { - "brief_title": "An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar\u00ae and Benicar\u00ae HCT in Patients With Hypertension", - "phase": "Phase 4", - "drugs": "['Olmesartan medoxomil', 'Olmesartan medoxomil/hydrochlorothiazide', 'Hydrochlorothiazide']", - "drugs_list": [ - "Olmesartan medoxomil", - "Olmesartan medoxomil/hydrochlorothiazide", - "Hydrochlorothiazide" - ], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "110.0", - "inclusion_criteria": "inclusion criteria: \n\n 1. 18 years of age. \n\n 2. Patients with stage II systolic hypertension \n\n 3. If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study. \n\n ", - "exclusion_criteria": ": \n\n 1. Hypertensive encephalopathy, stroke or transient ischemic attack (TIA) within the past 6 months. \n\n 2. History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months. \n\n 3. Severe hypertension (DBP greater than or equal to 110 mm Hg or SBP > 200 mm Hg). \n\n 4. History of secondary hypertension including renal disease, phaeochromocytoma, or Cushing's disease. \n\n 5. Type I diabetes mellitus. 6. Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease. \n\n 7. Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial fibrillation, or Atrial Flutter. \n\n 8. Laboratory test values considered clinically significant by the investigator. \n\n 9. Evidence of liver disease as indicated by SGOT or SGPT and/or total bilirubin > 3 times the upper limit of normal. \n\n 10. Pregnant or lactating females. \n\n 11. Patients with malignancy during the past 5 years excluding squamous cell or basal cell carcinoma of the skin.", - "brief_summary": "Effect of increasing doses of olmesartan medoxomil and olmesartan medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension", - "NCTID": "NCT00185068" - }, - { - "brief_title": "Effects of Coronary Sinus Occlusion on Myocardial Ischemia (Pilot Study)", - "phase": "", - "drugs": "['intermittent coronary sinus occlusion']", - "drugs_list": [ - "intermittent coronary sinus occlusion" - ], - "diseases": "['Coronary Artery Disease', 'Coronary Sinus', 'Circulation, Collateral', 'Ischemia', 'Collateral Flow Index']", - "diseases_list": [ - "Coronary Artery Disease", - "Coronary Sinus", - "Circulation", - "Collateral", - "Ischemia", - "Collateral Flow Index" - ], - "enrollment": "35.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 17 years \n\n Stable angina pectoris, patient electively referred for coronary angiography \n\n Written informed consent to participate in the study \n\n ", - "exclusion_criteria": " \n\n Acute coronary syndrome; unstable cardio-pulmonary conditions \n\n Congestive heart failure NYHA III-IV \n\n Previous coronary bypass surgery \n\n Q-wave myocardial infarction in the area undergoing CFI measurement \n\n Anatomical variants not allowing coronary sinus occlusion \n\n Severe valvular heart disease \n\n Severe hepatic or renal failure (creatinine clearance < 15ml/min) \n\n Pregnancy", - "brief_summary": "Coronary artery disease (CAD) is the leading cause of morbidity and mortality in industrialized countries despite advances in medical, interventional, and surgical revascularization therapies. In both, acute myocardial infarction (AMI) and chronic stable disease, standard therapeutic approaches may fail to restore tissue perfusion. Indeed, a substantial number of chronic CAD patients may not be amenable to standard revascularization therapies or percutaneous coronary intervention (PCI) may fail to restore coronary artery patency following an acute vessel occlusion (no-reflow phenomenon, microvascular obstruction). As a consequence, the long pursued strategy of augmenting myocardial perfusion by diverting blood from the coronary venous system to an ischemic region (venous retroperfusion) has again gained attention during recent years. Occlusion of the coronary sinus (CSO) was introduced to provide retroperfusion by transient augmentation of coronary venous pressure. Different devices using CSO have been invented and evaluated in animal models and small clinical trials, e.g. intermittent CSO (ICSO) and pressure-controlled intermittent CSO (PICSO) which seem to be effective for myocardial salvage. However, they are not yet employed in clinical routine, and importantly, the exact underlying mechanisms by which retroperfusion due to CSO may reduce myocardial ischemia are not yet understood.~As natural bypasses, coronary collaterals are anastomoses without an intervening capillary bed between portions of the same coronary artery or between different coronary arteries that represent an alternative source of blood supply to a myocardial area jeopardized by ischemia. Collaterals of the heart can be assessed quantitatively by coronary pressure measurements, which have become the gold standard (collateral flow index, CFI=[Poccl-CVP]/[Pao-CVP]). Theoretically, augmentation of coronary sinus pressure by CSO with an increase of venous backflow reaches the upstream collateral circulation, which in turn could lead to improved collateral flow from non-ischemic area(s) to an occluded, ischemic myocardial region by upstream flow diversion. On the other hand, when considering the formula to calculate pressure-derived CFI, it seems that augmentation of coronary back pressure would rather impair collateral flow (since central venous pressure is coronary sinus pressure). However, the regional effect of a global increase in coronary sinus pressure is unlikely to be as uniform as the above formula implies, i.e., the response is more pronounced in some than in other vascular territories. In experimental studies using dogs (with abundant collaterals), elevation of coronary sinus pressure caused an augmentation of regional myocardial blood flow in the collateralized area. In contrast, when ICSO was performed in pigs (which possess no preformed collaterals), it increased the pressure distal of an occluded LAD but did not improve blood flow or left ventricular function.~In conclusion, experimental studies and pathophysiologic considerations suggest a necessary role of the collateral circulation for the beneficial effects of coronary sinus occlusion (CSO) observed in animals and humans; however, no clinical data are available so far on the effect of CSO on myocardial ischemia in the presence of varying collateral flow.~Study hypotheses~CSO decreases intra-coronary ECG ST-segment elevation during a 2-minute coronary occlusion.~The decrease in occlusive intra-coronary ECG ST elevation during CSO is directly proportional to CFI.~Coronary sinus oxygen saturation during coronary occlusion with CSO is directly proportional to CFI.", - "NCTID": "NCT01625832" - }, - { - "brief_title": "Rosuvastatin Effect on Reducing Coronary Atherosclerosis Plaques Volume", - "phase": "Phase 4", - "drugs": "['Rosuvastatin']", - "drugs_list": [ - "Rosuvastatin" - ], - "diseases": "['Hyperlipidemia', 'Coronary Artery Disease']", - "diseases_list": [ - "Hyperlipidemia", - "Coronary Artery Disease" - ], - "enrollment": "600.0", - "inclusion_criteria": "inclusion criteria: \n\n Written informed consent \n\n Men or women, aged 18 -75 \n\n Diagnosed with coronary heart disease (CHD) stable angina for more than 1 month and meet the following any one: \n\n History of myocardial infarction. \n\n CHD confirmed by coronary angiography. \n\n Excercise ECG positive for CHD or perfusion defect \n\n One or more main branch of coronary artery stenosis \u2265 50% confirmed by CT scanning. \n\n Hyperlipidemia (lipid-lowering treatment na\u00efve: LDL-C \u2265130mg/dl, or having received lipid-lowering treatment: LDL-C \u2265100mg/dl) \n\n The 64 slice CT shows at least one significant coronary artery stenosis \u226520% with the narrowest \u226460% and meeting the following criteria: \n\n Diameter of coronary artery lesion \u22652mm, length \u22655mm; distance between multiple lesions >1cm \n\n Plaque density <100HU, no calcification \n\n Vascular stenosis (20\uff5e60%) caused by plaques \n\n Plaque thickness >1mm \n\n Plaque not in the coronary artery with previous PCI treatment. \n\n ", - "exclusion_criteria": ": \n\n Acute myocardial infarction within 6 months \n\n PCI or CABG therapy within 6 months \n\n Anticipated PCI or CABG therapy in the following 3 months. \n\n Tropnin I/Tropnin T higher than ULN \n\n Cardiac failure NYHA III or above \n\n Coronary artery left main stenosis >50% \n\n Emergency coronary angiography(CAG) is needed \n\n Serious arrhythmia or tachycardia \n\n Secondary hyperlipidemia \n\n Familial hypercholestrolemia \n\n Uncontrolled severe hypertension (\u2265200/110 mmHg) \n\n Uncontrolled diabetes (HbA1c \u22659.5%) \n\n Triglyceride \u2265500 mg/dL (5.65 mmol/L) \n\n Active hepatic disease or hepatic function impairment, ALT\u22653ULN \n\n Serum creatinine >177 \u00b5mol/L (2.0 mg/dL) \n\n Myalgia or blood CK \u22655ULN \n\n WBC < 4\u00d710e9/L\uff0cor PLT < 100*10e9/L\u3002 \n\n Participation in the the course of plan and/or procedure of this study \n\n Previous participation in the study treatment \n\n Participation in other clinical studies in the past 3 months \n\n Pregnant or breast-feeding women, women with child-bearing potential who did not use drugs or devices for contraception, or women with positive urine pregnancy test (human chorionic gonadotropin [HCG]) \n\n History of malignant tumors (exception: recovered more than 10 years or only basal cell carcinoma or squamous cell carcinoma); females with a history of cervical atypical hyperplasia (exception: 3 consecutive cervical smear tests normal prior to enrolment) \n\n History of alcohol and/or drug abuse in recent 5 years \n\n Any serious or unstable physical or psychological conditions, in the opinion of the investigator, would compromise the safety of the patient or the participation in this study \n\n Use of concomitant medications prohibited in this study ( Erythromycin, clarithromycin, erythromycin ethylsuccinate, sulfaphenazole; Fluconazole, ketoconazole, itraconazole; Niacin / nicotinic acid(including vitamins/food additives containing niacin / nicotinic acid >50mg), probucol, clofibrate, cholestyramine, colestipol hydrochloride, ezetimibe, fenofibrate, gemfibrozil, atorvastatin(exception: study medication)\uff0clovastatin, pravastatin, rosuvastatin (exception: study medication) , Simvastatin, fluvastatin, fish oil (any dose), lipid-lowering supplements and food additives; Cyclosporine; Protease inhibitors) \n\n Use of periodic hormone replacement treatment(HRT), oral contraceptives(OCTs), long-acting progesterone, or in recent 3 months non-periodic HRT or OCTs \n\n Patients with any condition which, in the investigator's judgment, might increase the risk to the subject for any adverse event or abnormal laboratory finding", - "brief_summary": "This multicentre, open-label, single-arm Study is to evaluate the effect of Rosuvastatin 20 mg 76 weeks on coronary atherosclerosis plaque versus baseline in Chinese coronary heart disease (CHD) patients with hyperlipidemia by measuring the plaque volume using a 64 slice spiral CT. Effect on blood lipids, hsCRP and Carotid intima-media thickness (CIMT) is also evaluated.", - "NCTID": "NCT01382277" - }, - { - "brief_title": "Rajavithi Health Promotion Project (Population Base Cohort)", - "phase": "", - "drugs": "['Intensive Education for Metabolic Syndrome Patients']", - "drugs_list": [ - "Intensive Education for Metabolic Syndrome Patients" - ], - "diseases": "['Diabetes Mellitus', 'Hypertension', 'Dyslipidemia', 'Obesity', 'Cardiovascular Disease', 'Coronary Artery Disease']", - "diseases_list": [ - "Diabetes Mellitus", - "Hypertension", - "Dyslipidemia", - "Obesity", - "Cardiovascular Disease", - "Coronary Artery Disease" - ], - "enrollment": "2000.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 16 years or more \n\n Informed consent \n\n Living in selected community (Health Promotion area of Rajavithi Hospital)", - "exclusion_criteria": "", - "brief_summary": "Metabolic Syndrome (hypertension, diabetes mellitus, obesity, cerebrovascular-cardiovascular disease) In Community Survey was performed in central Bangkok.~Prospective Cohort and intensive educated intervention (health promotion program in specific high risk groups) were performed. The aim of the study is to identify high risk patients who can develop serious complications from metabolic syndrome. An analysis of health outcomes in multiple dimensions will be performed.", - "NCTID": "NCT00368095" - }, - { - "brief_title": "Obstructive Sleep Apnoea in Patients With Intermittent Claudication", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Sleep Apnea']", - "diseases_list": [ - "Sleep Apnea" - ], - "enrollment": "140.0", - "inclusion_criteria": "inclusion criteria: \n\n Register to the social health insurance \n\n Referred for a walk test because of claudication \n\n Maximal walking ditance < 750m \n\n Older than 18 years old \n\n Able to understand the protocol of the study \n\n ", - "exclusion_criteria": ": \n\n Cardiac insufficiency already known, stage III or IV i.e. dyspnea at rest Unstable angina or myocardial infarction within the previous three months inclusion \n\n Severe reparatory disease already known \n\n Parkinson disease, h\u00e9mipl\u00e9gia ou parapl\u00e9gia \n\n Does not want to participate to the protocol \n\n Pregnant women \n\n Adults to enhanced protection, deprived of their liberty by judicial or administrative authority, without consent hospitalized or admitted to a health facility or social purposes other than research \n\n Being in a period of exclusion from another biomedical study", - "brief_summary": "The main aim of this study is to determine how common undiagnosed obstructive sleep apnoea is in individuals with intermittent claudication.", - "NCTID": "NCT01801592" - }, - { - "brief_title": "Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography", - "phase": "Phase 4", - "drugs": "['Iodixanol', 'Iopamidol']", - "drugs_list": [ - "Iodixanol", - "Iopamidol" - ], - "diseases": "['Drug Safety']", - "diseases_list": [ - "Drug Safety" - ], - "enrollment": "255.0", - "inclusion_criteria": "inclusion criteria: \n\n The subject is over 18 years old. \n\n Subjects are referred to undergo a peripheral arteriography as part of their routine clinical care. \n\n ", - "exclusion_criteria": ": \n\n The subject has known allergies to iodine or any prior history of adverse reaction to iodinated CM. \n\n The subject received another administration of CM within 24 hours prior to baseline or is scheduled to receive one within the 24 hour follow-up period. \n\n The subject is pregnant or lactating. \n\n The subject is taking metformin (e.g., Glucophage\u00ae) but is not willing or unable to discontinue at the time of the study procedure. \n\n The subject manifests thyrotoxicosis or is on dialysis.", - "brief_summary": "The purpose of this study is to evaluate and compare overall patient comfort profile between an Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients undergoing arteriography of peripheral arteries.", - "NCTID": "NCT01475097" - }, - { - "brief_title": "Treatment of Orthostatic Intolerance", - "phase": "Phase 1; Phase 2", - "drugs": "['Acetazolamide', 'Atomoxetine', 'NO Drug', 'Clonidine', 'Entacapone', 'Entacapone & Propranolol', 'Atomoxetine & Propranolol', 'Indomethacin', 'Mecamylamine', 'Isosorbide Dinitrate', 'Melatonin', 'Midodrine', 'Modafinil', 'Octreotide', 'Placebo', 'Propranolol', 'Modafinil & Propranolol', 'Sertraline', 'IV Saline', 'Drinking Water', 'Breathing Device', 'memantine', 'Abdominal binder']", - "drugs_list": [ - "Acetazolamide", - "Atomoxetine", - "NO Drug", - "Clonidine", - "Entacapone", - "Entacapone & Propranolol", - "Atomoxetine & Propranolol", - "Indomethacin", - "Mecamylamine", - "Isosorbide Dinitrate", - "Melatonin", - "Midodrine", - "Modafinil", - "Octreotide", - "Placebo", - "Propranolol", - "Modafinil & Propranolol", - "Sertraline", - "IV Saline", - "Drinking Water", - "Breathing Device", - "memantine", - "Abdominal binder" - ], - "diseases": "['Tachycardia', 'Chronic Orthostatic Intolerance']", - "diseases_list": [ - "Tachycardia", - "Chronic Orthostatic Intolerance" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Chronic symptoms (> 6 months) with standing upright \n\n ", - "exclusion_criteria": ": \n\n Obvious cause of hypovolemia or drugs that could worsen tachycardia \n\n Chronic severe medical conditions such as cancer or ischemic heart disease", - "brief_summary": "This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.", - "NCTID": "NCT00262470" - } - ], - "2": [ - { - "brief_title": "Effects of Remote Ischemic Preconditioning on Moderate PVD Patients A Pilot Randomized Control Trial", - "phase": "Phase 1", - "drugs": "['Remote Ischemic Preconditioning', 'Supervised Exercise', 'Standard Care']", - "drugs_list": [ - "Remote Ischemic Preconditioning", - "Supervised Exercise", - "Standard Care" - ], - "diseases": "['Peripheral Arterial Diseases']", - "diseases_list": [ - "Peripheral Arterial Diseases" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Known moderate PVD \n\n New claudication patient with Rutherford stage 2 and Fontaine stage 2a symptoms \n\n ", - "exclusion_criteria": ": \n\n Known upper limb PVD \n\n Severe cardiac condition \n\n Risk classification for exercise training: class C and above \n\n Severe respiratory condition \n\n Previous history of upper limb deep vein thrombosis \n\n Patients on glibenclamide or nicorandil- May affect RIPC \n\n Raynaud's Disease \n\n Contra indications for MRA \n\n Pregnancy \n\n Previous major limb amputation affect ability to exercise", - "brief_summary": "Remote ischemic Preconditioning (RIPC) is a phenomena first observed in cardio-thoracic patients in which exposing the limbs for periods of short intermittent ischemia produces protective effect on heart muscle. The concept was applied to many other parts of the body and the results are positive so far.~No human trials on this concept has been conducted in patients with peripheral vascular disease so far but applying the concept for healthy individuals shows vessels dilatation and animal trials shows degree of new vessels formation in addition to reports of symptoms improvement.~The trial candidates will be allocated blindly in 4 groups. All groups will have advice about exercise which is the standard practice now. The first group will have supervised exercise. The second group will in addition to the supervised exercise get the ischemic preconditioning with the blood pressure cuff. The third group will get the ischemic preconditioning and the fourth group will get the standard exercise advice. All candidates will have Magnetic Resonance Image Scan (MRA) for their blood vessels in the beginning of the trial and again at the end.~The effect of the RIPC (Remote ischemic Preconditioning) and exercises on patient symptoms, new vessel formation and other parameters will be recorded", - "NCTID": "NCT02273232" - }, - { - "brief_title": "Zilver Flex Post-Market Study in Japan", - "phase": "", - "drugs": "['Zilver Flex Bare Metal Stent']", - "drugs_list": [ - "Zilver Flex Bare Metal Stent" - ], - "diseases": "['Peripheral Arterial Disease (PAD)']", - "diseases_list": [ - "Peripheral Arterial Disease (PAD)" - ], - "enrollment": "239.0", - "inclusion_criteria": "inclusion criteria: \n\n Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries \n\n ", - "exclusion_criteria": ": \n\n -", - "brief_summary": "Japanese post market clinical study of the Zilver Flex device.", - "NCTID": "NCT02254356" - }, - { - "brief_title": "Phase II Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia", - "phase": "Phase 2", - "drugs": "['MESENDO', 'Placebo']", - "drugs_list": [ - "MESENDO", - "Placebo" - ], - "diseases": "['Critical Limb Ischemia', 'Severe Leg Ischemia', 'Peripheral Artery Disease', 'Peripheral Vascular Disease']", - "diseases_list": [ - "Critical Limb Ischemia", - "Severe Leg Ischemia", - "Peripheral Artery Disease", - "Peripheral Vascular Disease" - ], - "enrollment": "35.0", - "inclusion_criteria": "inclusion criteria: \n\n Males or females older than 18 years of age. \n\n Limb ischemia with ABI of < 0.7 in the index lower extremity in two consecutive examinations done at least 1 week apart. \n\n Limb ischemia with resting ischemic pain and/or claudication at 100 meters and/or non-healing ulcers. \n\n Claudication \n\n Patients not considered candidates for surgical or percutaneous revascularization, due to poor target vessels, inability to cross total occlusions, or a morbidity which precludes general anesthesia. \n\n ", - "exclusion_criteria": ": \n\n Inability to provide informed consent. \n\n Previous angiogenic therapy. \n\n Known sensitivity to gentamycin and/or amphotericin B. \n\n Use or expected use of antineoplastic drugs. \n\n Any illness, which might affect the patient's survival after enrollment in the protocol. \n\n Any illness or significant laboratory abnormality, which in the investigator's judgment will interfere with the patient's ability to comply with the protocol, compromise the patient's safety, or interfere with the interpretation of the study results. \n\n No evidence of acute infection \n\n WBC > 15000. \n\n WBC < 4000. \n\n Serum Creatinine > 3.0 mg/dL in patients who are not in hemodialysis. \n\n Pregnant women or women planning to become pregnant or unwilling to use appropriate birth control methods before and 2 months after cell infusion. \n\n Recent myocardial infarction within 3 months prior to screening.", - "brief_summary": "The purpose of this research study is to compare in patients with double-sided claudication if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in one of the severly diseased ischemic limbs(legs)versus the control limb that receives a placebo product.~Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decrease blood flow to the extremities (mainly feet and legs) and has progressed to the point of severe pain and even skin ulcers or sores.~LI needs comprehensive treatment since the condition will not improve on its own. The overall goal of treatment is to reduce pain and increase blood flow to improve symptoms or save the leg and feet. In many cases, current options for treatment including medications, surgery or endovascular procedures have not been successful.~In the last few years, investigators have explored therapies aimed to increase blood flow to the ischemic vessel by transplanting cells that will promote the development of new vessels in the diseased leg.~The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriated blood supply to the leg.~Patients eligible to participate in the this study are those suffering from double-sided claudication with poor circulation or severe leg blockages, which are not candidates for surgical procedures.~Once the mixture of stem cells is prepared and the patient's bone marrow is ready, cells will be transplanted into the calf muscle of one the the diseased legs while the other diseased leg will receive the placebo. Clinical study to evaluate and compare the efficacy of the stem cell transplant will be performed for six months post cell transplant.", - "NCTID": "NCT00721006" - } - ] - }, - { - "patient_id": "sigir-20151", - "patient": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", - "0": [ - { - "brief_title": "Endoscopic Therapy for Bleeding Marginal Ulcers After Gastric Bypass", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Bleeding Marginal Ulcer']", - "diseases_list": [ - "Bleeding Marginal Ulcer" - ], - "enrollment": "45.0", - "inclusion_criteria": "inclusion criteria: \n\n patients status post laparoscopic RYGB surgery with active gastrointestinal hemorrhage secondary to marginal ulcer \n\n ", - "exclusion_criteria": ": \n\n bleeding marginal ulcers after other bariatric procedures \n\n staple-line bleeding after RYGB \n\n iron-deficiency anemia (chronic) secondary to non-actively bleeding marginal ulcer after RYGB \n\n other sources of GI bleeding different from marginal ulcer such as from staple-lines, complicated PUD, and other surgical and medical causes of GI hemorrhage \n\n missing records and/or unreachable patients with scant information for analysis", - "brief_summary": "The objective of this study is to identify the incidence rate; describe the risk factors, clinical presentation, and endoscopic treatment; assess the morbidity, mortality, and overall performance of the management of patients with actively bleeding marginal ulcers after Roux-en-Y gastric bypass (RYGB) surgery.", - "NCTID": "NCT01040416" - }, - { - "brief_title": "Use of PillCam ESO2 in Triaging Patients Present With Upper GIB", - "phase": "", - "drugs": "['PillCam ESO2']", - "drugs_list": [ - "PillCam ESO2" - ], - "diseases": "['Upper Gastrointestinal Bleeding']", - "diseases_list": [ - "Upper Gastrointestinal Bleeding" - ], - "enrollment": "68.0", - "inclusion_criteria": "inclusion criteria: \n\n Individual aged \u2265 18 years presenting to the emergency department with acute, overt UGIB defined as coffee ground vomiting and/or melena \n\n ", - "exclusion_criteria": ": \n\n UGIB with hemodynamic shock (BP<90mmHg and pulse>120 per minutes) requiring urgent endoscopy, \n\n UGIB with fresh hematemesis requiring urgent endoscopy \n\n dysphagia, odynophagia, swallowing disorder, Zencker's diverticulum, suspected bowel obstruction or bowel perforation, \n\n prior bowel obstruction, gastroparesis or known gastric outlet obstruction, Crohn's disease, past GI tract surgery. \n\n presence of an electromedical device (pacemaker or internal cardiac defibrillator), \n\n altered mental status (e.g., hepatic encephalopathy) that would limit patient ability in swallowing the capsule, pregnancy and/or lactating, allergy to conscious sedation medications, allergy to Maxolon, unwillingness to swallow the capsule, patient expected to undergo Magnetic Resonance Imaging examination within 7 days of ingesting the capsule, patient on medications that may coat the upper GI tract such as antacids or sucralfate, or inability to provide written informed consent. \n\n Allergy to Maxolon \n\n Patients with known Esophageal Varices or Gastric Varices with or without prior bleeding episodes \n\n Known upper/ lower GI cancer (eg, cancer of esophagus, stomach, small bowel, colon) or hepatocellular carcinoma or pancreatic cancer", - "brief_summary": "Background~Patients presented to hospital with coffee ground vomiting and black stool may not be actually having upper gastrointestinal bleeding (UGIB)~Hospital admission can be avoided if serious UGIB can be excluded~To date, the only useful tool to triage patient for hospital admission in UGIB is by using clinical score such as Rockall score or Blatchford score~These scores are cumbersome and only exclude the most benign cases, but they are not useful in differentiating those who needs intervention~In our pilot study, investigators found that capsule endoscopy can be used to identify patients with fresh blood and real coffee ground substance in the stomach and it is superior to nasogastric tube~Most of UGI lesions leading to bleeding can be diagnosed by capsule endoscopy~Objectives The current study is designed~to validate capsule endoscopy is an effective method in identifying patients with UGIB~to study whether the capsule endoscopy can reduce requirement of hospital admission in patients with suspected UGIB~to study if capsule endoscopy can help to identify patients with UGIB that may require urgent (within 24 hours) endoscopy and intervention~to study the cost-effectiveness of capsule endoscopy being used as a triaging tool in the management of UGIB~to compare the effectiveness of capsule endoscopy against Blatchford score in identifying patients with UGIB that may require endoscopic intervention.", - "NCTID": "NCT02446678" - }, - { - "brief_title": "China Survey of Stress Ulcer Bleeding in Critically Ill Neurosurgical Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Stress Ulcers', 'Stress-related Mucosal Disease (SRMD)']", - "diseases_list": [ - "Stress Ulcers", - "Stress-related Mucosal Disease (SRMD)" - ], - "enrollment": "1416.0", - "inclusion_criteria": "inclusion criteria: \n\n The subject population that will be included in the NIS are the consecutive discharged patients \u226518 years old who were hospitalized to Neurosurgical departments. Those whose Glasgow Coma Scale (GCS) \u226410[4] within 24 hours of lesion/admission will be defined as critically ill patients. Three kinds of cases will be included: brain trauma critically ill patients, cerebral haemorrhage critically ill patients or postoperative brain tumour critically ill patients. \n\n ", - "exclusion_criteria": ": \n\n If participating in any clinical trial, the subject cannot take part in this study. Subjects are ineligible if they have below conditions: \n\n Those who were likely to swallow blood (for example, those with severe facial trauma or epistaxis; \n\n Patients with previous total gastrectomy; \n\n Known upper GI lesions that might bleed (e.g., varices, polyps, tumours, etc); \n\n Evidence of active GI bleeding including oesophageal and gastric variceal bleeding, Peptic Ulcer Disease (PUD)", - "brief_summary": "Stress ulcers or stress-related mucosal disease (SRMD) is defined as acute superficial inflammation lesions of the gastric mucosa induced when an individual is subject to abnormally elevated physiologic demands.[1] Studies have shown that SRMD occurred in 75%-100% ICU patients[1]. Gastrointestinal bleeding due to SRMD is an important complication in critically ill patients. The frequency of clinically important bleeding ranged from 5.3% to 33%.[2] The mortality in ICU patients with stress related bleeding approaches 50%, which is much higher than the patients without bleeding (9%). [3] In 1999, the American Society of Health-System Pharmacists (ASHP) published guidelines on the use of stress ulcer prophylaxis in medical, surgical, respiratory, and pediatric ICU patients [2]. PPIs and H2RA are widely used in China current clinical practice for the prevention of stress ulcer bleeding. However, there is no epidemiology data to show the risk factors for stress ulcer bleeding and the bleeding rate of Chinese neurosurgical critically ill patients who are usually suffering from brain trauma, cerebral haemorrhage or brain tumour operation. Information is needed to know about the characteristics in Chinese critically ill neurosurgical patients.~Objectives of this Non-Interventional Study Primary~Primary objective: To estimate the overall incidence of upper gastrointestinal (GI) bleeding in critically ill neurosurgical patients in China.~Main secondary objective~To estimate the incidence of upper GI bleeding with clinically significant complications in critically ill neurosurgical patients in China.~To estimate the incidence of any overt upper GI bleeding without clinically significant complications in critically ill neurosurgical patients in China.~To assess time to upper GI bleeding after a cerebral lesion.~To investigate potential risk factors associated with upper GI bleeding, and assess how common certain risk factors occurred in upper GI bleeding patients.~To assess the overall incidence of upper GI bleeding in critically ill patients by different risk factors for upper GI bleeding.~To investigate the drugs, the route of administration, the doses and the duration commonly used for stress ulcer prophylaxis.~To investigate the proportion of ICU patients with nasogastric tube, and the duration of nasogastric tube.~(ICU: Intensive care unit PPIs: Proton pump inhibitors H2RA: H2 receptor antagonist)", - "NCTID": "NCT02316990" - }, - { - "brief_title": "Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT", - "phase": "Phase 2; Phase 3", - "drugs": "['Repamipide', 'Placebo']", - "drugs_list": [ - "Repamipide", - "Placebo" - ], - "diseases": "['Gastric Ulcer Induced by Anti-platelet Agent', 'Duodenal Ulcer Induced by Anti-platelet Agent']", - "diseases_list": [ - "Gastric Ulcer Induced by Anti-platelet Agent", - "Duodenal Ulcer Induced by Anti-platelet Agent" - ], - "enrollment": "142.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18-70 year-old \n\n Had cardiovascular disease which needed clopidogrel and aspirin \n\n Stable enough for gastroscopy \n\n ", - "exclusion_criteria": ": \n\n Gastroscopy revealed peptic ulcer \n\n Had contraindication for gastroscopy \n\n Not allowed for gastroscopy by cardiologist", - "brief_summary": "Primary objective : To evaluate the efficacy of Rapamide in peptic ulcer prevention in patients taking dual antiplatelet agents~Study Design: Single center, double-blind, randomized-control trial study~Study drug: Repamipide vs. placebo~Assessment criteria The patients will be discharged from the study when one of the followings occurred,~Peptic ulcer from upper endoscopy at 3 and 6 month follow up~Clinical of upper gastrointestinal bleeding with peptic ulcer from upper endoscopy~Anemia by CBC at 1,3 ,6,12 month with peptic ulcer from upper endoscopy~Evidence of recurrent myocardial infarction from stent thrombosis", - "NCTID": "NCT02166008" - }, - { - "brief_title": "Natural History of Non-steroidal Anti-inflammatory Drug and Non-Helicobacter Pylori in Bleeding Peptic Ulcers", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Peptic Ulcer']", - "diseases_list": [ - "Peptic Ulcer" - ], - "enrollment": "391.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient has non-NSAID (non-steroidal anti-inflammatory drugs), non-Helicobacter pylori bleeding peptic ulcer \n\n Age > 18 years old \n\n Informed consent \n\n ", - "exclusion_criteria": ": \n\n Concommitant use of high dose steroid or warfarin \n\n New start on non-steroidal anti-inflammatory drugs or aspirin or COX2 inhibitors \n\n Renal failure (serum creatinine > 200umol/l) \n\n Previous gastric surgery \n\n Oesophagitis, esophageal varices \n\n Terminal illness or malignancy", - "brief_summary": "The aim of this study is to study the natural history of the ulcer healing while on proton pump inhibitors (PPI) and the ulcer recurrence without acid suppression therapy of Non-steroidal Anti-inflammatory Drugs (NSAID), non-Helicobacter pylori (HP) bleeding ulcer patients.", - "NCTID": "NCT00153712" - }, - { - "brief_title": "Injection of Cyanoacrylate+Lipiodol vs Cyanoacrylate+Lauromacrogol in Gastric Varices", - "phase": "", - "drugs": "['Lipiodol', 'Lauromacrogol']", - "drugs_list": [ - "Lipiodol", - "Lauromacrogol" - ], - "diseases": "['Gastric Varices', 'Portal Hypertension']", - "diseases_list": [ - "Gastric Varices", - "Portal Hypertension" - ], - "enrollment": "96.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients presented to our hospital with acute gastric variceal bleeding, with or without liver cirrhosis. \n\n The age of the patients range from 18 to 80 years old. \n\n ", - "exclusion_criteria": ": \n\n Patients who have contraindications for cyanoacrylate, lipiodol or lauromacrogol therapy. \n\n Patients who have abnormal portosystemic shunt according to the imaging results. \n\n Patients who have no previous upper gastrointestinal bleeding history. \n\n Patients who have multiple endoscopic treatments for esophagogastric varices before.", - "brief_summary": "The purpose of this randomized study to compare effect of endoscopic injection of a mixture of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.", - "NCTID": "NCT01923064" - }, - { - "brief_title": "A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers", - "phase": "Phase 4", - "drugs": "['aspirin']", - "drugs_list": [ - "aspirin" - ], - "diseases": "['Peptic Ulcer']", - "diseases_list": [ - "Peptic Ulcer" - ], - "enrollment": "178.0", - "inclusion_criteria": "inclusion criteria: \n\n aspirin users who have a peptic ulcer confirmed by endoscopy \n\n ", - "exclusion_criteria": ": \n\n serious medical illness (including cardiovascular events within 6 months before endoscopy) \n\n acute gastrointestinal bleeding \n\n a history of gastric or duodenal surgery \n\n allergic to the study drugs \n\n require long-term treatment with non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, or anticoagulant agents \n\n pregnancy", - "brief_summary": "Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.", - "NCTID": "NCT01353144" - }, - { - "brief_title": "Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma", - "phase": "Phase 2", - "drugs": "['0.9% Sodium Chloride 250 mL bolus', '0.9% Sodium Chloride 2000 mL bolus']", - "drugs_list": [ - "0.9% Sodium Chloride 250 mL bolus", - "0.9% Sodium Chloride 2000 mL bolus" - ], - "diseases": "['Blunt Trauma', 'Penetrating Wound', 'Hemorrhagic Shock']", - "diseases_list": [ - "Blunt Trauma", - "Penetrating Wound", - "Hemorrhagic Shock" - ], - "enrollment": "192.0", - "inclusion_criteria": "inclusion criteria: Included will be those with: \n\n Blunt or penetrating injury \n\n Age \u226515yrs or weight \u226550kg if age is unknown \n\n Prehospital SBP \u2264 90 mmHg \n\n ", - "exclusion_criteria": ": Excluded will be those with: \n\n Ground level falls \n\n Evidence of severe blunt or penetrating head injury with a Glasgow Coma Scale (GCS) \u2264 8 \n\n Bilateral paralysis secondary to suspected spinal cord injury \n\n Fluid greater than 250ml was given prior to randomization \n\n Cardiopulmonary resuscitation (CPR) by Emergency Medicine Service (EMS) prior to randomization \n\n Known prisoners \n\n Known or suspected pregnancy \n\n Drowning or asphyxia due to hanging \n\n Burns over a Total Body Surface Area (TBSA) > 20% \n\n Time of call received at dispatch to study intervention > 4 hours", - "brief_summary": "Primary Aim: To determine the feasibility and safety of hypotensive resuscitation for the early treatment of patients with traumatic shock compared to standard fluid resuscitation.~Primary Hypotheses: The null hypothesis regarding feasibility is that hypotensive resuscitation will result in the same volume of early crystalloid (normal saline) fluid administration compared to standard crystalloid resuscitation. The null hypothesis regarding safety is that hypotensive resuscitation will result in the same percent of patients surviving to 24 hours after 911 call received at dispatch compared to standard fluid resuscitation. Early resuscitation is defined as all fluid given until 2 hours after arrival in the Emergency Department or until hemorrhage control is achieved in the hospital, whichever occurs earlier.", - "NCTID": "NCT01411852" - }, - { - "brief_title": "Hypertonic Resuscitation Following Traumatic Injury", - "phase": "Phase 3", - "drugs": "['7.5% hypertonic saline/6% Dextran-70 (HSD)', '7.5% hypertonic saline (HS)', '0.9% normal saline']", - "drugs_list": [ - "7.5% hypertonic saline/6% Dextran-70 (HSD)", - "7.5% hypertonic saline (HS)", - "0.9% normal saline" - ], - "diseases": "['Shock, Traumatic']", - "diseases_list": [ - "Shock", - "Traumatic" - ], - "enrollment": "895.0", - "inclusion_criteria": "inclusion criteria: \n\n Blunt or penetrating trauma \n\n Prehospital Systolic Blood Pressure (SBP) <= 70;OR \n\n Prehospital SBP 71-90 AND Hear Rate (HR) \u2265108 \n\n 15 years of age or older, or 50kg or more if age unknown \n\n ", - "exclusion_criteria": ": \n\n Known or suspected pregnancy \n\n Age younger than 15 or less than 50kg if age unknown \n\n Ongoing prehospital cardiopulmonary resuscitation (CPR) \n\n Administration of more than 2000cc crystalloid or any colloid or blood products \n\n Severe hypothermia (suspected Temperature less than 28 degrees celsius) \n\n Drowning or asphyxia due to hanging \n\n Burns Total Body Surface Area (TBSA) more than 20% \n\n Isolated penetrating injury to the head \n\n Inability to obtain prehospital intravenous access \n\n Time of call received at dispatch to study intervention greater than four hours \n\n Known prisoners", - "brief_summary": "The purpose of this study is to determine if hypertonic saline with and without dextran can improve overall survival in victims of trauma with shock.~Injury and lost blood from trauma can cause your body to be in shock (low blood pressure related to blood loss). This decreased blood flow can lead to organ damage. In order to restore the blood pressure and blood flow, the medics give fluids into the patients' veins as soon as possible. This is called resuscitation. The resuscitation fluid most commonly used is isotonic or one that is the same concentration as the blood. The investigators are trying to determine if infusing a hypertonic fluid (or one more concentrated than the blood) can increase the blood pressure and restore blood flow more efficiently. The hypertonic fluids the investigators are using are called hypertonic saline with dextran (HSD) and hypertonic saline (no dextran). Hypertonic saline is a salt solution that is slightly more concentrated than your blood. Dextran is a sugar solution.", - "NCTID": "NCT00316017" - }, - { - "brief_title": "Induction of Mild Hypothermia in Resuscitated Cardiac Arrest Patients", - "phase": "Phase 2; Phase 3", - "drugs": "['mild hypothermia']", - "drugs_list": [ - "mild hypothermia" - ], - "diseases": "['Cardiac Arrest']", - "diseases_list": [ - "Cardiac Arrest" - ], - "enrollment": "64.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female patients \u2265 18 years. \n\n Witnessed out-of-hospital cardiac arrest of presumed cardiac origin in which the initial rhythm is ventricular fibrillation, ventricular tachycardia, pulseless electrical activity (PEA) or asystole. \n\n First attempt at resuscitation (ACLS or CPR) by emergency medical personnel initiated within 15 minutes of collapse. \n\n Restoration of spontaneous circulation (ROSC) within 60 minutes of collapse. \n\n Time from restoration of spontaneous circulation to initiation of cooling is \u2264 6 hours. \n\n Informed consent provided by authorized representative/family member. \n\n ", - "exclusion_criteria": ": \n\n Temperature of less than 35\uf0b0C on admission. \n\n Comatose or vegetative state prior to cardiac arrest. \n\n Positive pregnancy test. \n\n Purposeful response to verbal commands after ROSC and prior to initiation of hypothermia. \n\n Evidence of hypotension (MAP<60) for more than 30 minutes after ROSC and prior to initiation of hypothermia. \n\n Evidence of hypoxia (oxygen saturation<85% despite supplemental oxygen) for more than 15 minutes after ROSC and prior to initiation of hypothermia. \n\n Terminal illness that preceded the arrest (life expenctancy < 1 year). \n\n Patients experiencing cardiogenic shock. \n\n Patients continuing to experience refractory ventricular arrhythmias at the time of enrollment. \n\n Patients receiving 2 or more high dose vasopressors. \n\n Active bleeding or known preexisting coagulapathy. \n\n Patient history of cold agglutinin disease. \n\n Patient history of Raynaud's Disease. \n\n Patient history of Sickle Cell disease. \n\n Evidence of compromised skin integrity or irregularities (such as urticaria, rash, lacerations, burns, abrasions. \n\n Patient weight > 114 kg (250 lbs) or < 50 kg (110 lbs) \n\n Enrollment in another therapeutic study.", - "brief_summary": "The primary objectives of this study are to determine the safety and feasibility of inducing mild hypothermia using a non-invasive thermoregulatory device, the Medivance Arctic Sun Temperature Management System, in patients resuscitated after cardiac arrest.", - "NCTID": "NCT00282373" - }, - { - "brief_title": "Different Fluidic Strategy in Patients With Acute Abdomen : The Sure Volume", - "phase": "Phase 2", - "drugs": "['Standard fluidic resuscitation.', 'Volemic small treatment']", - "drugs_list": [ - "Standard fluidic resuscitation.", - "Volemic small treatment" - ], - "diseases": "['Acute Abdomen']", - "diseases_list": [ - "Acute Abdomen" - ], - "enrollment": "99.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients with acute abdomen undergoing abdominal surgery under emergency and presenting on arrival in ICU at least a sign of bad perfusion. \n\n ", - "exclusion_criteria": ": \n\n Patients with chronic renal failure already receiving dialysis treatment \n\n Acute Coronary Syndrome (ACS) <12 months and New York Hearth Classification (NHYA ) class > 3 \n\n Patients judged at the admission not subject to resuscitative measures for severity and comorbidity \n\n Patients with massive hemorrhage in operative room or in the immediate perioperative with the need for blood transfusions and abundant blood products > 5 units of Erytrocyte Concentrates (EC) \n\n Patients scheduled for Orthotopic Liver Transplantation (OLT) \n\n Patients younger than 18 years old", - "brief_summary": "Acute abdomen is the clinical manifestation of irritation of the peritoneum, due to intra-abdominal generalized infection. With the exception of the primary ones which are the result of a bacterial translocation from the gastro-intestinal tract or an abdominal contamination for hematogenous way sometimes treatable with medical therapy alone, peritonitis represents a complex condition that requires an early surgical treatment.~Mortality linked to the peritonitis is extremely high and variable between 42% and 80% when associated with a systemic framework of severe sepsis. This variability is linked to a number of risk factors, including advanced age of the patients, the presence of comorbidity, male sex, a poor nutritional status, and a number of re-operations; as well as specific characteristics related to the type of infection, the timing of surgery, the beginning of an appropriate and early antibiotic therapy.The post-operative treatment of the patient with peritonitis significantly affects the outcome of the same. The presence of peritonitis and then the seizure of large volumes of liquids and the possible state of systemic vasodilation induced by the infectious process, provide a framework of hypovolemia. There is a literature that identifies in abdominal trauma damage patient's volemic aggressive resuscitation an element of pejorative outcomes. The purpose of this work is to evaluate the clinical changes determined by a different volemic strategy.", - "NCTID": "NCT01911702" - }, - { - "brief_title": "Peptic Ulcer Disease in Ischemic Heart Patients Taking Aspirin and Clopidogrel With or Without Proton Pump Inhibitor", - "phase": "", - "drugs": "['lansoprazole', 'aluminum hydroxide 334 mg and Mg hydroxide 166 mg']", - "drugs_list": [ - "lansoprazole", - "aluminum hydroxide 334 mg and Mg hydroxide 166 mg" - ], - "diseases": "['Peptic Ulcer', 'Ulcer Complications']", - "diseases_list": [ - "Peptic Ulcer", - "Ulcer Complications" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients are eligible if they have received PCI for their stenotic coronary arteries and taken both aspirin and clopidogrel. \n\n Patients who had a past history of PUD without complication, who have taken aspirin or clopidogrel before enrolling for their CV disease will be allowed to enroll. \n\n ", - "exclusion_criteria": ": \n\n Patients are excluded if they have New York Heart Association class IV heart failure, if they had contraindications to antithrombotic or antiplatelet therapy, if they have clinical severe thrombocytopenia (platelet count< 80000/mm3), if they have previous disabling, or hemorrhagic stroke or intracranial hemorrhage, if they have severe and unstable conditions in hepatic, renal, and pulmonary disease, if they have unstable and progressive malignancy, if they have epigastralgia or have a positive occult blood in stool, if they have current or recent PUD and take PPI or histamine receptor-2 antagonist without proving healed ulcer by scopy, if they have received a surgical intervention due to PUD complication (bleeding, perforation, obstruction) in the past, if they have received a GP IIb/IIIa inhibitor fewer than 3 days before randomization.", - "brief_summary": "Studies showed that combined use of clopidogrel and aspirin had a 25 % reduction of risk on myocardial infarction and stroke in patients who undergone percutaneous coronary intervention (PCI) when compared with use of aspirin alone. However, major GI bleeding rose in combined group than aspirin group. Use of proton pump inhibitor (PPI) which diminishes gastric acid secretion effectively reduces aspirin or clopidogrel associated ulcer or/and ulcer bleeding in general population and high risk patients. The investigator hypothesis is whether use of PPI can reduce ulcer and ulcer complication in patients taking both clopidogrel and aspirin.", - "NCTID": "NCT00854776" - }, - { - "brief_title": "Control of Major Bleeding After Trauma Study", - "phase": "Phase 2", - "drugs": "['Type AB plasma', 'Crystalloid fluid (standard of care for resuscitation)']", - "drugs_list": [ - "Type AB plasma", - "Crystalloid fluid (standard of care for resuscitation)" - ], - "diseases": "['Trauma', 'Hemorrhagic Shock']", - "diseases_list": [ - "Trauma", - "Hemorrhagic Shock" - ], - "enrollment": "144.0", - "inclusion_criteria": "inclusion criteria: \n\n Age>=18 years \n\n Acutely injured \n\n SBP<70 mmHg or SBP 71-90 mmHg with heart rate (HR)>108 beats per minute. \n\n ", - "exclusion_criteria": ": \n\n Visibly or verbally reported pregnant women \n\n known prisoners \n\n unsalvageable injuries (defined as asystolic or cardiopulmonary resuscitation prior to randomization) \n\n known objection to blood products \n\n the patient has an opt-out bracelet or, necklace or wallet card \n\n a family member present at the scene objects to the patient's enrollment in research.", - "brief_summary": "Bleeding is the most avoidable cause of death in trauma patients. Up to one-third of severely injured trauma patients are found to be coagulopathic and forty percent of the mortality following severe injury is due to uncontrollable hemorrhage in the setting of coagulopathy. It has been established that early administration of fresh frozen plasma decreases mortality following severe injury, replacing lost coagulation factors, improving the coagulopathy and restoring blood volume. This study will determine if giving plasma to severely injured trauma patients during ambulance transport versus after arrival to the hospital will help reduce hemorrhage, thus decreasing both total blood product administration and mortality.", - "NCTID": "NCT01838863" - }, - { - "brief_title": "Retroperitoneal Packing or Angioembolization for Hemorrhage Control of Pelvic Fractures", - "phase": "", - "drugs": "['PACKING', 'ANGIO']", - "drugs_list": [ - "PACKING", - "ANGIO" - ], - "diseases": "['Shock, Hemorrhagic', 'Fractures, Bone', 'Multiple Trauma']", - "diseases_list": [ - "Shock", - "Hemorrhagic", - "Fractures", - "Bone", - "Multiple Trauma" - ], - "enrollment": "56.0", - "inclusion_criteria": "inclusion criteria: \n\n multitrauma defined as Injury Severity Score (ISS) > 17 \n\n dislocated pelvic fracture type B or C according to Tile[10] on emergency department pelvic radiograph \n\n hemodynamic instability defined as systolic blood pressure (SBP) <90 mmHg after administration of 4 units of packed red blood cells (PRBC). \n\n ", - "exclusion_criteria": ": \n\n monotrauma, or ISS \u2264 17 \n\n age > 65 years \n\n age < 18 years", - "brief_summary": "This study is designed to answer whether minimal invasive vessel clotting (angioembolization) or open surgery (retroperitoneal packing) is more effective for pelvic fractures with massive bleeding. Patients admitted at daytime (7am-5pm) are treated with angioembolization while patients admitted at nighttime (5pm to 7am) are treated with open surgery.", - "NCTID": "NCT02535624" - }, - { - "brief_title": "Prevention of Gastric Ulcer Bleeding by Using Computer-alert in General Practice", - "phase": "", - "drugs": "['Computer-alert', 'A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors', 'Computer-alert']", - "drugs_list": [ - "Computer-alert", - "A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors", - "Computer-alert" - ], - "diseases": "['Bleeding Peptic Ulcer']", - "diseases_list": [ - "Bleeding Peptic Ulcer" - ], - "enrollment": "220.0", - "inclusion_criteria": "inclusion criteria: \n\n General practitioners in the Region of Southern Denmark which are linked to Danish General Medical Database for minimum 6 months \n\n ", - "exclusion_criteria": ": \n\n -", - "brief_summary": "The purpose of this study is to investigate if a computerised decision-support tool used in general practice, can reduce the frequency of peptic ulcer bleeding related to the use of NSAIDs (Non-Steroidal-antiinflammatory-drug) and ASA( Acetylsalicylic acid) .~On the basis of The Danish general medical database it is possible to develope a computerised decision-support tool, which enables the general practitioner (GP) in a pop-up window to get information on each patients risk-factors, when prescribing NSAID and aspirin to a patient at risk. This will give the general practitioner the oppurtunity to choose a different type of preparation or prescribe ulcer-preventive medicine at the same time.~The decision-support tool will be tested in a randomized trial among general practitioners. The aim is to reduce the occurence of peptic ulcer bleeding. The expected outcome is a reduction in half of the total numbers of peptic ulcers.", - "NCTID": "NCT01845168" - }, - { - "brief_title": "Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer", - "phase": "Phase 2", - "drugs": "['esomeprazole']", - "drugs_list": [ - "esomeprazole" - ], - "diseases": "['Peptic Ulcer']", - "diseases_list": [ - "Peptic Ulcer" - ], - "enrollment": "165.0", - "inclusion_criteria": "inclusion criteria: \n\n We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months. \n\n ", - "exclusion_criteria": ": \n\n 1.serious disease 2.refuse informed consent", - "brief_summary": "Proton Pump Inhibitors (PPI) can prevent the recurrence of peptic ulcer in clopidogrel users.", - "NCTID": "NCT01138969" - }, - { - "brief_title": "Ondansetron Versus Metoclopramide in Treatment of Vomiting in Gastroenteritis", - "phase": "Phase 4", - "drugs": "['Treatment 1. Metoclopramide', 'Treatment 2 Ondansetron']", - "drugs_list": [ - "Treatment 1. Metoclopramide", - "Treatment 2 Ondansetron" - ], - "diseases": "['Gastroenteritis']", - "diseases_list": [ - "Gastroenteritis" - ], - "enrollment": "170.0", - "inclusion_criteria": "inclusion criteria: \n\n All acute gastroenteritis patient between 1-14 years presenting to PEC Al Saad with diarrhea, persistent vomiting , fail oral rehydration and admitted to the observation unit for intravenous hydration will be eligible for the study. \n\n ", - "exclusion_criteria": ": \n\n Previous abdominal surgery \n\n Suspicion of surgical abdominal \n\n Bile stained vomitus \n\n History of hepatic and renal illnesses \n\n In-born error of metabolism \n\n Children with shock or impending shock \n\n Sever dehydration. \n\n Previous hypersensitivity or abnormal reaction to metoclopramide or ondansetron \n\n Antiemetic treatment within 48 hours prior to presentation. \n\n Seizure disorder", - "brief_summary": "Is intravenous metoclopramid as effective as intravenous ondansetron in the treatment of persistent vomiting in patients with acute gastroenteritis.", - "NCTID": "NCT01165866" - }, - { - "brief_title": "Ephedrine vs. Nor Epinephrine Infusion in Preventing Hypotension After Spinal Anesthesia for Cesarean Section", - "phase": "Phase 4", - "drugs": "['Norepinephrine', 'Ephedrine']", - "drugs_list": [ - "Norepinephrine", - "Ephedrine" - ], - "diseases": "['Anesthesia; Adverse Effect, Spinal and Epidural', 'Hypotension', 'Complications; Cesarean Section']", - "diseases_list": [ - "Anesthesia; Adverse Effect", - "Spinal and Epidural", - "Hypotension", - "Complications; Cesarean Section" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n The American Society of Anesthesiologists (ASA) Physical Status classification 1 and 2 \n\n Pregnant women with singleton pregnancy \n\n Gestational age greater than 36 weeks \n\n Cesarean delivery under spinal anesthesia \n\n ", - "exclusion_criteria": ": \n\n Use of cardiac medication or medication for blood pressure control \n\n Cardiovascular disease \n\n Multiple gestation \n\n Gestation diabetes requiring insulin \n\n Refusal to be in study \n\n History of chronic opioid use (chronic pain syndrome) \n\n Emergent caesarean delivery for maternal and/or fetal distress \n\n Preeclampsia \n\n Eclampsia \n\n Progressive neurologic disease \n\n Infection at insertion site \n\n Allergy to local anesthetics, narcotics or other study medications", - "brief_summary": "The purpose of the study is to determine if norepinephrine is more effective as a continuous intravenous (IV) infusion compared to continuous IV ephedrine associated with crystalloid loading for maintaining blood pressure during a spinal anesthetic for a cesarean delivery. Prevention of low blood pressure has been shown to decrease nausea and vomiting during and after cesarean delivery under spinal anesthesia. For elective cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and morphine. This study plans to enroll 120 pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of two groups.", - "NCTID": "NCT02477501" - }, - { - "brief_title": "Efficacy and Safety of PMK-S005 in the Prevention of Recurrent Peptic Ulcer in Low-dose Aspirin Users", - "phase": "Phase 2", - "drugs": "['Placebo', 'PMK-S005 1', 'PMK-S005 2', 'PMK-S005 3']", - "drugs_list": [ - "Placebo", - "PMK-S005 1", - "PMK-S005 2", - "PMK-S005 3" - ], - "diseases": "['Peptic Ulcer']", - "diseases_list": [ - "Peptic Ulcer" - ], - "enrollment": "88.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female over 19 years of age \n\n Accompanied by hypertension, diabetes, ischemic heart disease, arrhythmia, dyslipidemia patients who are required to continuous administration of low-dose aspirin(100mg) \n\n Patients who get Modified Lanza Score (MLS) 0 in screening period according to endoscopic findings \n\n Patients who have stomach or duodenal ulcer scar in screening period according to endoscopic findings. But, the cases that scars caused by other disorders or endoscopic treatment are excluded \n\n Patients who have no digestive symptoms(except for mild physconia, abdominal pain, diarrhea and vomit, nausea-vomiting) in screening period \n\n Signature of the written informed consent \n\n ", - "exclusion_criteria": ": \n\n Within 4 weeks prior to screening period, patients who continuously take aspirin or NSAIDs \n\n Patient who has hypersensitivity to PMK-S005 and aspirin components or is banned to use them \n\n Patients who had a abdominal surgery that affect gastrointestinal motility (Except appendectomy and hysterectomy), But, patients who had enterectomy is excluded regardless of the time period \n\n Patients who are judged by investigator that they have other upper gastroesophageal disease, active/healing-stage peptic ulcer, digestive malignant tumor or Barrett's esophagus \n\n Patients with Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), Ulcerative Colitis, Crohn's disease, Zolinger-Ellison syndrome \n\n History of esophagus, liver, pancreas, stomach, colorectal cancer or malignant tumors within 5 years \n\n History of malabsorption within 3 months prior to screening period \n\n Patients who have been taken drug that affect the validity within 2 weeks before beginning of the clinical test \n\n Patient who is needed continuously to take antithrombotic agents , anti- coagulant , anti- choline agents, prostaglandins , mucosal protective agents , methotrexate, antidepressants , iron treat agents during clinical test. \n\n Patients with clinical meaningful laboratory test results \n\n Known alcohol and/or any other drug abuse or dependence \n\n Pregnant or lactating women \n\n Women planning to become pregnant \n\n Within 1 month, patients who have been taken other clinical test drug \n\n Patients who are judged by investigator that participation of the study is difficult", - "brief_summary": "The purpose of this study is to evaluate the efficacy and safety by comparing prevention of recurrent peptic ulcer in low-dose aspirin users between PMK-S005 and Placebo.", - "NCTID": "NCT02342470" - }, - { - "brief_title": "Perforated Marginal Ulcer After Gastric Bypass", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Ulcer Disease After Gastric Bypass', 'Marginal Ulcer', 'Perforated Marginal Ulcer', 'Acutely Perforated Marginal Ulcer']", - "diseases_list": [ - "Ulcer Disease After Gastric Bypass", - "Marginal Ulcer", - "Perforated Marginal Ulcer", - "Acutely Perforated Marginal Ulcer" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Laparoscopic repair of perforated marginal ulcer after RYGB \n\n ", - "exclusion_criteria": ": \n\n Perforated marginal ulcers after other bariatric procedures \n\n Repair by open approach \n\n Missing records and/or unreachable patients with scant information for analysis", - "brief_summary": "A common late complication after gastric bypass surgery is marginal ulceration that is defined as ulcers at the margins of the gastrojejunostomy, mostly on the jejunal side. Most marginal ulcers respond to medical therapy and complicated or complex ulcer disease warrants operative intervention; specifically, perforated, penetrated, obstructing, bleeding and intractable marginal ulcers require surgical intervention.~Diverse operative strategies for addressing perforated marginal ulcers after gastric bypass have been described including I) Omental (Graham) patch repair, II) Revision of gastrojejunostomy, III) Irrigation and drainage, IV) any previous procedure with truncal vagotomy, V) Esophagojejunostomy, and VI) Reversal. We formally analyze our experience with the laparoscopic resection and repair of acutely perforated marginal ulcers after Roux-en-Y gastric bypass (RYGB), with or without concomitant resolution of technical risk factors for marginal ulceration.", - "NCTID": "NCT01041196" - }, - { - "brief_title": "Comparison of Low-Molecular-Weight Heparin (LMWH) and Unfractionated Heparin (UFH) in Combination With Thrombolytic Treatment of Acute Massive Pulmonary Thromboembolism", - "phase": "Phase 4", - "drugs": "['enoxaparin ,alteplase, unfractionated heparin']", - "drugs_list": [ - "enoxaparin ,alteplase", - "unfractionated heparin" - ], - "diseases": "['This Study Will Provide Data Comparing Safety of LMWH Versus UFH in the Treatment of Acute PE Cases Who Require Thrombolytic Treatment.']", - "diseases_list": [ - "This Study Will Provide Data Comparing Safety of LMWH Versus UFH in the Treatment of Acute PE Cases Who Require Thrombolytic Treatment." - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults, age \u2265 18 years \n\n Patients who have signed the study informed consent form prior to initiation of any study-related procedure. \n\n Acute massive PE patients who require thrombolytic treatment. \n\n ", - "exclusion_criteria": ": \n\n Patients who have a contraindication to use of anticoagulation and thrombolysis, such as active bleeding, stroke, cranial trauma, or neurologic surgery within the preceding 6 months, current pregnancy, major surgery, or biopsy within the preceding 7 days, major trauma within the preceding 10 days, gastrointestinal bleeding within the preceding 1 months during their admission. \n\n Patients who received any anticoagulation medication prior to admission to the hospital.", - "brief_summary": "Purpose and rationale: Acute pulmonary embolism (PE) is a common and often fatal disease, with an approximately 30% mortality rate without treatment. Treatment is important to reduce mortality and recurrence in acute PE. Therapeutic options for PE include subcutaneous low molecular weight heparin (SC LMWH), intravenous unfractionated heparin (IV UFH), subcutaneous unfractionated heparin and subcutaneous fondaparinux with or without thrombolysis. In the treatment of acute PE, SC LMWH has been shown, at least, as effective and safe as IV UFH [4]. Compared to IV UFH, SC LMWH associated with lower mortality, fewer recurrent thrombotic events and less major bleeding. Current guidelines recommend use of SC LMWH for most hemodynamically stable patients with PE and they say that SC LMWH have not been tested in the setting of acute massive PE.~The purpose of this study is to demonstrate that SC LMWH is as safe as IV UFH in the treatment of acute PE in combination with thrombolytic treatment.", - "NCTID": "NCT01956955" - }, - { - "brief_title": "A Phase I Study of Monoclonal Antibody TB-402 in Healthy Male Volunteers", - "phase": "Phase 1", - "drugs": "['TB-402', 'Placebo']", - "drugs_list": [ - "TB-402", - "Placebo" - ], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "56.0", - "inclusion_criteria": "inclusion criteria: \n\n Males 18 to 45 (Groups 1-9) or 55 to 75 (Group 10) years of age \n\n No clinically important abnormal physical, laboratory, ECG findings \n\n Normal (or abnormal but ncs) supine blood pressure (BP) and heart rate (HR) \n\n ", - "exclusion_criteria": ": \n\n Self or family history of cardiovascular or pulmonary disorder, coagulation or bleeding disorders or reasonable suspicion of vascular malformations eg cerebral haemorrhage, aneurysm or premature stroke. \n\n Any autoimmune disease. \n\n Previous allergic reaction to immunoglobulin. \n\n Present, or history of, severe allergy, for example asthma or anaphylactic reactions or allergy requiring treatment. \n\n Consumption of aspirin, other non-steroidal anti-inflammatory drugs or other drugs known to affect platelet function or any other aspect of coagulation within 14 days before drug administration. \n\n Abnormal platelet function or clinically significant out of range values for any coagulation tests. \n\n History of important bleeding episodes eg haematemesis, rectal bleeding, severe or recurrent epistaxis, haemoptysis, haematuria or intracranial haemorrhage. \n\n Screening FVIII:C < 50%.", - "brief_summary": "Dose escalation study to assess the safety and tolerability of TB-402, a monoclonal antibody directed against FVIII, versus placebo in healthy male volunteers.", - "NCTID": "NCT00612196" - }, - { - "brief_title": "Temperature Control in Central Fever in the Neuro-ICU", - "phase": "Phase 4", - "drugs": "['Gaymar Rapr-Round (external cooling blanket)']", - "drugs_list": [ - "Gaymar Rapr-Round (external cooling blanket)" - ], - "diseases": "['Fever', 'Brain Hemorrhage']", - "diseases_list": [ - "Fever", - "Brain Hemorrhage" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Two or more days with core temperature \u2265 100.4F \n\n Approval of the patient's primary attending physician \n\n Need for core temperature measurement independent of the study. \n\n Admission to the Neuro-ICU [intensive care unit] for an underlying condition \n\n ", - "exclusion_criteria": ": \n\n Evidence for an infectious cause of fever, such as pneumonia, bacteremia, CNS [central nervous system] infection or urinary tract infection. \n\n Expected death from any cause \n\n Known sensitivity to the device \n\n History of pre-admission hypothalamic dysfunction or known temperature dysregulation \n\n Use of 2 or more vasopressor medications, since this may make a local skin reaction to the device more likely \n\n Hemodynamic instability", - "brief_summary": "There are few treatments for central fever (fever that is due to the central nervous system, as opposed to an infectious source). We hypothesize that an externally applied cooling blanket will reduce temperature in neurologically ill patients with central fever.", - "NCTID": "NCT00751634" - }, - { - "brief_title": "Clinical and Economical Interest of Endovascular Cooling in the Management of Cardiac Arrest (ICEREA Study)", - "phase": "Phase 4", - "drugs": "['Comparison of 2 cooling procedures']", - "drugs_list": [ - "Comparison of 2 cooling procedures" - ], - "diseases": "['Hypothermia', 'Heart Arrest']", - "diseases_list": [ - "Hypothermia", - "Heart Arrest" - ], - "enrollment": "389.0", - "inclusion_criteria": "inclusion criteria: \n\n Age between 18 and 79 years old \n\n Out-of-hospital cardiac arrest (OH-CA) due to a presumed cardiac etiology \n\n Delay between OH-CA and return of spontaneous circulation (ROSC) < 60 minutes \n\n Delay between ROSC and starting cooling < 240 minutes \n\n Patient not obeying verbal command after ROSC and prior to starting cooling \n\n Availability of the CoolGard device (ALSIUS product) \n\n ", - "exclusion_criteria": ": \n\n Do not reanimate order or terminal disease before inclusion \n\n Known pregnancy \n\n Clinical hemorrhagic syndrome or known coagulopathy \n\n Contra-indication to device usage (such as femoral venous access impossible) \n\n Hypothermia at admission < 30\u00b0C \n\n Etiology of OH-CA thought to be extra-cardiac (trauma, bleeding or anoxia) \n\n In hospital cardiac arrest \n\n Refractory shock (need for extra-corporeal life support)", - "brief_summary": "According to international guidelines, mild therapeutic hypothermia is recommended for resuscitated patients after cardiac arrest due to ventricular fibrillation. Whether external or internal cooling is superior in terms of prognosis or security remains unknown. The aim of this study is to evaluate in a randomized trial the clinical and economical interests of the endovascular cooling versus the conventional external cooling for the management of hypothermia after cardiac arrest.", - "NCTID": "NCT00392639" - }, - { - "brief_title": "Risk of Uncomplicated Peptic Ulcer in the General Population", - "phase": "", - "drugs": "['Risk of symptomatic peptic ulcer']", - "drugs_list": [ - "Risk of symptomatic peptic ulcer" - ], - "diseases": "['Peptic Ulcer [Iowa Type (107680.0010)]']", - "diseases_list": [ - "Peptic Ulcer [Iowa Type (107680.0010)]" - ], - "enrollment": "4000.0", - "inclusion_criteria": "inclusion criteria: \n\n - Patients aged 40-84 years in 1997-2005 ( see study population description) \n\n ", - "exclusion_criteria": ": \n\n - Patients aged below age 40 and 85 years and above ( see study population description)", - "brief_summary": "The analyses are conducted in a previous population-based cohort study using The Health Improvement Network database in the UK (Cai et al 2009).The aims of the post hoc analyses are:~To estimate the relative risk of uncomplicated symptomatic peptic ulcer (UPU) associated with use of low dose aspirin (ASA) and other anti-inflammatory drugs (NSAIDs, steroids) in the general population To estimate the dose-response and duration-response associated with use of these drugs To estimate the relative risk of UPU associated with naive/non-naive use of low dose ASA in the general population To evaluate the effect of proton pump inhibitors (PPI) (alone or in combination with anti-inflammatory drugs) on the occurrence of UPU in the general population To investigate the management of low dose ASA/oral antiplatelets after UPU", - "NCTID": "NCT01888588" - }, - { - "brief_title": "AScVS and/ or Prazosin for Scorpion Envenomation", - "phase": "Phase 3", - "drugs": "['Antiscorpion venom serum(AScVS).', 'T.Prazosin', 'AScVS + Prazosin']", - "drugs_list": [ - "Antiscorpion venom serum(AScVS).", - "T.Prazosin", - "AScVS + Prazosin" - ], - "diseases": "['Scorpion Envenomation']", - "diseases_list": [ - "Scorpion Envenomation" - ], - "enrollment": "81.0", - "inclusion_criteria": "inclusion criteria: (All of the following) \n\n Patients of both sexes, in the age range of 12-65 years \n\n reporting to the PHC/ hospital within 48 hours of scorpion sting and \n\n associated with s/s of scorpion envenomation having composite score between 5 and 21 (as computed based on the criteria below:) \n\n Criteria Grade Symptoms \n\n Sweating 0 Limited to the extremity of the sting site. \n\n Minimal sweating all over the body, slight nasal secretions \n\n Generalized sweating with rigors and cold extremities. \n\n Gen.profuse sweating,wetting of clothes and cold clammy skin. \n\n Pulse rate 0 70- 90 \n\n 91 - 100 \n\n 101 - 120 or < 70 \n\n 121 - 140 or < 60 or irreg pulse \n\n 141 - 160 \n\n > 160 \n\n Respiratory rate 0 < 20 \n\n 20 - 30 \n\n 31 - 40 without crepitations \n\n 31 - 40 with crepitations \n\n > 40 with crepitations \n\n > 40 with crepitations and cyanosis \n\n Blood pressure 0 120/80 \n\n Systolic: 121 -140 and diastolic: 81 -90 \n\n Systolic: 141 -160 and diastolic: 91-100 \n\n Syst: 161 -180 and diast: 101-110 Or syst <100 \n\n Syst: 181 -200 and diast: 111-120 Or syst <100 \n\n Syst: > 200 and diast: >120 Or syst < 60 \n\n CNS effects 0 No sensory involvement \n\n Minimal tingling numbness around mouth \n\n Tingling, numbness around mouth and giddiness \n\n Altered sensorium, patient roudy \n\n Patient semiconscious \n\n Patient unconscious \n\n Priapism 2 Slight erection 3 Strong erection \n\n To obtain a composite score, grades for individual criterion will be added. Maximum score: 25 and minimum score: 0 \n\n ", - "exclusion_criteria": ": (Any of the following) \n\n Composite score less than 5 and greater than 21. \n\n Grade of 5 in any of the criterion \n\n Severe Pulmonary edema with oxygen saturation below 80%. \n\n Severe scorpion envenomation with reporting time more than 2 days \n\n Any other serious medical disease which/treatment of which may confound the results e.g. cardiac diseases, diabetes, renal diseases etc. \n\n Severe anaphylactic reaction to any of the study drugs \n\n Patient (or relative in case of child) not willing to participate", - "brief_summary": "The data available for the efficacy of AScVS and prazosin is generated through different trials done in different clinical setting. Hence it was felt worthwhile to confirm the documented efficacy of AScVS and prazosin in terms of time taken for clinical recovery in a clinical trial. Along with this, effects of both the therapies on various biochemical parameters will be recorded and compared with. It was also felt necessary to study the effect of combination on the clinical outcome.", - "NCTID": "NCT00753064" - }, - { - "brief_title": "Nimotuzumab in Combination With Chemoradiation for Esophageal Cancer", - "phase": "Phase 1", - "drugs": "['Nimotuzumab']", - "drugs_list": [ - "Nimotuzumab" - ], - "diseases": "['Advanced Esophageal']", - "diseases_list": [ - "Advanced Esophageal" - ], - "enrollment": "11.0", - "inclusion_criteria": "inclusion criteria: \n\n Informed consent form signed before performing any of the study's specific procedures. \n\n ECOG performance status 0-2. \n\n Age > 18 and < 75. \n\n Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, greater than or equal to 1 cm (longest diameter) by spiral computed tomography (CT) scan and MRI or greater than or equal to 2 cm by other ordinary radiographic technique. \n\n Histologically confirmed diagnosis of locally advanced esophageal. \n\n Life expectancy of more than 3 months. \n\n Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy. \n\n No serious blood producing,abnormal function of heart,lung, liver, or kidney or immuno-deficiency \n\n Neutrophils \u22653\u00d7109/L, platelet count\u2265100\u00d7109/L and haemoglobin\u22659g/dL ,Creatinine \u2264 1.5 x NUL \n\n ", - "exclusion_criteria": ": \n\n Previous radiotherapy or chemotherapy \n\n Pregnant or breast-feeding women \n\n Drug abuse, unhealthy drug/alcohol addiction,or virus (HIV) infection \n\n Evidence of distant metastasis \n\n Participation in other clinical trials \n\n Patients with aphthosis, complete obstruction, fistula or deep peptic ulcer in the esophagus, or haematemesis \n\n Uncontrolled psychiatric disease or seizure \n\n Patients not fit for the clinical trial judged by the investigators", - "brief_summary": "Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The phase I study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemo-radiotherapy in patients with locally advanced esophageal cancer tumours.", - "NCTID": "NCT00950417" - }, - { - "brief_title": "A Closer Look at the Effect of Dextrose on Postoperative Nausea and Vomiting", - "phase": "", - "drugs": "['Intravenous fluid', 'D5LR or lactated ringers']", - "drugs_list": [ - "Intravenous fluid", - "D5LR or lactated ringers" - ], - "diseases": "['Postoperative Nausea and Vomiting']", - "diseases_list": [ - "Postoperative Nausea and Vomiting" - ], - "enrollment": "202.0", - "inclusion_criteria": "inclusion criteria: \n\n ASA I or II \n\n female urologic, gynecologic and breast surgery patients undergoing scheduled same day procedures at LLUMC Heart and Surgical Hospital \n\n ", - "exclusion_criteria": ": \n\n age <18 or >65; \n\n severe hypertension,diabetes mellitus, significant hepatic or renal disease \n\n excessive blood loss \n\n sustained (>10 min)>20% from baseline drop in BP after treatment \n\n inability to follow protocol \n\n refusal to sign consent", - "brief_summary": "The purpose of this investigator-initiated study is to see if giving dextrose fluid in the veins (IV) decreases the risk of postoperative nausea and vomiting (PONV) in female urologic, gynecologic and breast outpatient surgery patients and at what blood surgery level. The reason for this study is that IV dextrose has been shown to decrease the incidence of PONV and the use of medications to treat PONV, while leading to sooner discharge after surgery. This can decrease overall healthcare cost and improving patient satisfaction.", - "NCTID": "NCT01123837" - } - ], - "1": [ - { - "brief_title": "European Survey of Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Non-variceal Upper Gastrointestinal Bleeding', 'Gastrointestinal Ulcer', 'Gastrointestinal Hemorrhage']", - "diseases_list": [ - "Non-variceal Upper Gastrointestinal Bleeding", - "Gastrointestinal Ulcer", - "Gastrointestinal Hemorrhage" - ], - "enrollment": "2500.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients admitted to the hospital or inpatients with an overt non-variceal upper GI bleed manifesting as hematemesis/coffee ground vomiting, melena, hematochezia, as well as other clinical/laboratory evidences of acute blood loss from the upper GI tract \n\n Evidence that an upper GI endoscopy was performed \n\n The complete medical record is available for study related hospitalization. \n\n ", - "exclusion_criteria": ": \n\n NA", - "brief_summary": "The aim of this study is to assess the current management strategies in a pan-European real-life setting to uncover the unmet need in this area: non-variceal gastrointestinal bleedings.", - "NCTID": "NCT00797641" - }, - { - "brief_title": "Transfusion in Gastrointestinal Bleeding", - "phase": "Phase 2; Phase 3", - "drugs": "['Restrictive transfusion policy', 'Liberal Transfusion Policy']", - "drugs_list": [ - "Restrictive transfusion policy", - "Liberal Transfusion Policy" - ], - "diseases": "['Gastrointestinal Hemorrhage']", - "diseases_list": [ - "Gastrointestinal Hemorrhage" - ], - "enrollment": "936.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults aged 18 or over years presenting with AUGIB, defined by haematemesis or melaena. \n\n ", - "exclusion_criteria": ": \n\n Patients with whom the responsible clinician considers there is a need for immediate RBC transfusion prior to obtaining or regardless of the initial Hb result due to severity of bleeding. \n\n Existing hospital in-patients who develop AUGIB.", - "brief_summary": "Aim: To evaluate the feasibility and safety of a restrictive versus liberal red blood cell (RBC) transfusion policy in adult patients admitted with Acute Upper Gastrointestinal Bleeding (AUGIB) in order to inform the design of a definitive phase III randomised controlled trial.", - "NCTID": "NCT02105532" - }, - { - "brief_title": "High Versus Standard Dose of Proton Pump Inhibitors (PPIs) in Peptic Ulcer Bleeding", - "phase": "Phase 3", - "drugs": "['omeprazole', 'pantoprazole']", - "drugs_list": [ - "omeprazole", - "pantoprazole" - ], - "diseases": "['Peptic Ulcers', 'Upper Gastrointestinal Bleeding']", - "diseases_list": [ - "Peptic Ulcers", - "Upper Gastrointestinal Bleeding" - ], - "enrollment": "450.0", - "inclusion_criteria": "inclusion criteria: \n\n Consecutive patients admitted for upper gastrointestinal bleeding secondary to peptic ulcers that have been successfully treated with endoscopic therapy \n\n ", - "exclusion_criteria": ": \n\n Variceal esophageal bleeding \n\n Concurrent PPI use \n\n Moribund patients", - "brief_summary": "High intravenous dosage of Proton Pump Inhibitors is not better than standard dosage in bleeding peptic ulcers successfully treated by endoscopic therapy", - "NCTID": "NCT00374101" - }, - { - "brief_title": "Helicobacter Pylori Empiric Treatment in Ulcer Bleeding", - "phase": "Phase 4", - "drugs": "['Empirical Hp eradication', 'Eradication treatment guided by a positive test']", - "drugs_list": [ - "Empirical Hp eradication", - "Eradication treatment guided by a positive test" - ], - "diseases": "['Peptic Ulcer Hemorrhage']", - "diseases_list": [ - "Peptic Ulcer Hemorrhage" - ], - "enrollment": "178.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients older than 18. \n\n Informed Consent signed. \n\n Diagnosis of no variceal upper gastrointestinal bleeding secondary to a duodenal ulcer, erosive duodenitis or gastric ulcer. \n\n Life expectancy longer than 6 months. \n\n Able to attend further clinical controls. \n\n Absence of the following ", - "exclusion_criteria": ". \n\n ", - "brief_summary": "The goal of the study is to compare the effectiveness of empirical Helicobacter pylori treatment compared with treatment depending on diagnostic tests for Helicobacter pylori in patients with Upper gastrointestinal bleeding due to peptic ulcer. Main hypothesis is that empirical treatment will reduce the number of patients lost to follow-up thus improving the cure rates of Hp infection.", - "NCTID": "NCT00687336" - }, - { - "brief_title": "Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage", - "phase": "", - "drugs": "['Doppler ultrasound probe']", - "drugs_list": [ - "Doppler ultrasound probe" - ], - "diseases": "['Peptic Ulcer Hemorrhage']", - "diseases_list": [ - "Peptic Ulcer Hemorrhage" - ], - "enrollment": "121.0", - "inclusion_criteria": "inclusion criteria: \n\n Clean base ulcer with severe upper GIB (defined as melaena, hematochezia, hematemesis, and/or gross blood in NG lavage), and any one of the following: \n\n SBP \u2264 90mmHg; P of \u2265110 bpm; or orthostatic changes with SBP drops 20mmHg or P increases 20 bpm; or, \n\n Transfusion of 2 or more units of packed red blood cells within 12 hrs of admission; or, \n\n A documented HCT drop of at lest 6% from baseline. \n\n Endoscopically confirmed bleeding from GU, DU, pyloric ulcer, or anastomotic ulcer \n\n Pt can either have primary or secondary acute UGI haemorrhage \n\n ", - "exclusion_criteria": ": \n\n Bleeding site from lesion other than GU, DU, pyloric or anastomotic ulcer \n\n there is more than one type of significant bleeding lesion \n\n Documented hx of cirrhosis / portal HT \n\n ESRF requiring any form of dialysis \n\n Expected or persistent (>24hrs) coagulopathy with INR> 1.5 \n\n Platelet count is under 50000/mm3 \n\n Aspirin User / Plavix [Clopidogrel] User \n\n If the ulcer is neoplastic \n\n Cannot obtained consent \n\n Age < 18 or is pregnant \n\n Severe comorbid of which life expectancy <30 days", - "brief_summary": "The aim of study is to evaluate whether Doppler ultrasound can accurately identify patients who are at risk of recurrent bleeding, who will require endoscopic therapy, and who will fail endoscopic therapy.", - "NCTID": "NCT00164905" - }, - { - "brief_title": "Effect of IV and Oral Esomeprazole in Prevention of Recurrent Bleeding From Peptic Ulcers After Endoscopic Therapy", - "phase": "Phase 3", - "drugs": "['Oral esomeprazole', 'Intravenous Esomeprazole']", - "drugs_list": [ - "Oral esomeprazole", - "Intravenous Esomeprazole" - ], - "diseases": "['Bleeding', 'Peptic Ulcer']", - "diseases_list": [ - "Bleeding", - "Peptic Ulcer" - ], - "enrollment": "263.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 18 \n\n Confirmed ulcer bleeding with Forrest Ia, Ib, IIa, IIb \n\n Endoscopic hemostasis achieved \n\n Informed consent obtained \n\n ", - "exclusion_criteria": ": \n\n No consent \n\n Forrest II c, III (clear ulcer base/flat spot and no active bleeding, i.e., minimal risk for rebleeding) \n\n Unsuccessful endoscopic treatment (i.e., injection and/or thermal coagulation for the initial bleeding) or severe bleeding that immediate surgery is indicated \n\n Moribund patients in whom active treatment of any form is not considered. \n\n Polytrauma, severe injury, unconsciousness, burns, or need for continuous artificial ventilation \n\n Upper GI malignancy or disseminated malignant disease \n\n Esophageal varices \n\n A Mallory-Weiss lesion \n\n Phenytoin or theophylline treatment \n\n Uses of PPI or H2RAs within 3 days of admission, including uses at Emergency Department N.B. Usage of aspirin or NSAID is not an ", - "brief_summary": "The investigators previously showed that the use of a high-dose intravenous PPI regimen after endoscopic control of bleeding from peptic ulcers reduced rate of recurrent bleeding, decreased the need for endoscopic and surgical interventions and in general improved patients' outcomes. A trend towards reduced mortality associated with the use of high-dose intravenous PPI was also observed. Recent clinical trials from Asia have provided evidence that high-dose oral PPIs are associated with a reduction in rebleeding. Current meta-analysis suggests that both high dose (intravenous) and low dose (oral) PPIs effectively reduce rebleeding vs placebo. However, there has been no clinical study to compare IV infusion to oral PPI in this patient population.~The purpose of this clinical study is to compare the efficacy and safety of intravenous and oral Esomeprazole in patients with peptic ulcer hemorrhage who are at risk for recurrent bleeding. The investigators hypothesize that using IV infusion is superior to oral PPI.", - "NCTID": "NCT01142245" - }, - { - "brief_title": "ASP (PPI_H2RA) Study-H2RA Versus PPI for the Prevention of Recurrent UGIB in High-risk Users of Low-dose ASA", - "phase": "Phase 3", - "drugs": "['Rabeprazole', 'Famotidine']", - "drugs_list": [ - "Rabeprazole", - "Famotidine" - ], - "diseases": "['Upper Gastrointestinal Bleeding']", - "diseases_list": [ - "Upper Gastrointestinal Bleeding" - ], - "enrollment": "264.0", - "inclusion_criteria": "inclusion criteria: \n\n A history of documented peptic ulcer bleeding (self-reported history without confirmation by the clinician is not acceptable) \n\n Negative tests for H. pylori or successful eradication of H. pylori based on urease test or histology \n\n Expected regular use of ASA for the duration of the trial \n\n Age \u2265 18 \n\n Written informed consent obtained \n\n ", - "exclusion_criteria": ": \n\n A history of gastric or duodenal surgery other than patch repair \n\n Severe erosive esophagitis (LA grade C or D) \n\n Gastric outlet obstruction \n\n Terminal illness \n\n Active malignancies", - "brief_summary": "Peptic ulcer bleeding associated with ASA or NSAIDs is a major cause of hospitalization in Hong Kong. The investigators previously showed that ASA or NSAIDs accounted for about half of all cases of hospitalizations for peptic ulcer bleeding. Currently, ASA use has contributed to about one-third of the bleeding ulcers admitted to the investigators hospital that serves a local population of 1.5 million.~In patients with acute coronary syndrome or acute ischemic stroke who develop ASA-induced bleeding peptic ulcers, whether ASA should be discontinued before ulcers have healed is a major dilemma. In another double-blind randomized trial, the investigators have shown that discontinuation of ASA after endoscopic treatment of bleeding ulcers was associated with a significantly increased in mortality within 8 weeks.~In the absence of safer aspirins, co-therapy with a gastroprotective drug remains the dominant preventive strategy. Given the vast number of people taking ASA, however, it is only cost-effective to identify and treat those who are at high risk of ulcer bleeding and who have a strong indication for ASA use. Data from observational studies and randomized trials have consistently shown that PPIs are effective in reducing the risk of ulcer bleeding associated with ASA. Other potential preventive strategies include eradication of H. pylori infection, substitution of ASA for other non-aspirin anti-platelet drugs, and co-therapy with misoprostol or H2RAs.", - "NCTID": "NCT01408186" - }, - { - "brief_title": "Long-term Oral Esomeprazole for Prevention of Peptic Ulcer Rebleeding in High-risk Patients", - "phase": "Phase 4", - "drugs": "['oral esomeprazole 20 mg twice daily', 'oral esomeprazole 20 mg once daily']", - "drugs_list": [ - "oral esomeprazole 20 mg twice daily", - "oral esomeprazole 20 mg once daily" - ], - "diseases": "['Peptic Ulcer Hemorrhage']", - "diseases_list": [ - "Peptic Ulcer Hemorrhage" - ], - "enrollment": "268.0", - "inclusion_criteria": "inclusion criteria: \n\n Eligible participants included patients \u226520 years who had undergone gastroscopy for melena, haematochezia, or haematemesis due to bleeding peptic ulcers with major stigmata of recent hemorrhage. The major stigmata of recent haemorrhage were classified as Forrest class Ia, Ib, IIa, and IIb. All of the stigmata are given one or a combination of endoscopic therapies, including local injection of diluted epinephrine 1:10000, bipolar heated probe, argon plasma coagulation, band ligation, or hemoclip therapy. Patients will undergo a follow-up endoscopy about 12 to 16 weeks later to confirm that the ulcer has healed to be less than 0.5 cm; otherwise, patients are not enrolled. \n\n ", - "exclusion_criteria": ": \n\n Patients are excluded if they had tumor bleeding or ulcer bleeding due to the presence of a Dieulafoy lesion or mechanical factors (e.g, gastrostomy tube induction), comorbid with reflux esophagitis grade C or D, Barrett's esophagus, or marginal ulcer bleeding, hypersensitivity to esomeprazole or any component of the formulation, or had previously participated in the study. Because of concern for patient safety with certain drug-drug interactions, patients who receive anti-platelet therapy, e.g., aspirin, clopidogrel, or others for prophylaxis of established cardiovascular or cerebrovascular diseases will be excluded.", - "brief_summary": "The purpose of this study is to determine whether a long-term prophylactic use of esomeprazole 20 mg twice daily or once daily has prevention effectiveness in reducing the recurrence of peptic ulcer bleeding after ulcer healed with 16-week oral esomeprazole therapy in high-risk patients whose Rockall score \u2265 6.", - "NCTID": "NCT02456012" - }, - { - "brief_title": "Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)", - "phase": "Phase 3", - "drugs": "['Esomeprazole 40 mg', 'Esomeprazole 20 mg', 'Placebo']", - "drugs_list": [ - "Esomeprazole 40 mg", - "Esomeprazole 20 mg", - "Placebo" - ], - "diseases": "['Gastric Ulcer', 'Duodenal Ulcer']", - "diseases_list": [ - "Gastric Ulcer", - "Duodenal Ulcer" - ], - "enrollment": "2426.0", - "inclusion_criteria": "inclusion criteria: \n\n Daily intake of low-dose Aspirin (ASA) - The subject must fulfill at least one of the following (a-e): \n\n Aged \u226565 years. \n\n Aged \u226518 years and with a documented history of uncomplicated peptic ulcer(s). \n\n Aged \u226560 years and na\u00efve to low-dose ASA (ie, treatment started within 1 month prior to randomization). \n\n Aged \u226560 years and with stable coronary artery disease. \n\n Aged \u226560 years and with complaints of upper gastrointestinal (GI) symptoms that, as judged by the investigator, requires an Esophagogastroduodenoscopy (EGD) and with the finding of \u22655 gastric and/or duodenal erosions at the baseline endoscopy. \n\n ", - "exclusion_criteria": ": \n\n Peptic ulcer(s) at baseline esophagogastroduodenoscopy (EGD). \n\n Reflux esophagitis Los Angeles (LA) classification grade C or D at baseline \n\n History of peptic ulcer complications such as clinically significant bleeding and/or perforation.", - "brief_summary": "The purpose of this study is to compare the effect of esomeprazole 20 or 40 mg once daily versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid.", - "NCTID": "NCT00441727" - }, - { - "brief_title": "Early Selective TAE to Severely Bleeding Peptic Ulcers After Their Initial Endoscopic Hemostasis", - "phase": "", - "drugs": "['TAE', 'No TAE']", - "drugs_list": [ - "TAE", - "No TAE" - ], - "diseases": "['Bleeding', 'Peptic Ulcer', 'Arterial Embolization']", - "diseases_list": [ - "Bleeding", - "Peptic Ulcer", - "Arterial Embolization" - ], - "enrollment": "258.0", - "inclusion_criteria": "inclusion criteria: \n\n Actively bleeding peptic ulcers (Forrest I), NBVV or Forrest IIa ulcer, \n\n Successful endoscopic hemostasis by combination treatment of injected epinephrine followed by either 3.2mm heat probe 30J (4 continuous pulses) or hemo-clipping (at least 2 clips) And one of the followings \n\n Spurting hemorrhage during endoscopy; \n\n Ulcer >= 2 cm is determined by an opened biopsy forceps; \n\n Hb on admission of < 9 g/dl; or \n\n Hypotension prior to endoscopy defined by SBP of <90 mmHg AND HR of >110 bmp \n\n ", - "exclusion_criteria": ": \n\n -", - "brief_summary": "The aim of this study is to determine if early angiographic embolization can forestall recurrent bleeding in selected high risk ulcers after their initial endoscopic control; to validate prospectively the investigators proposed in selecting high risk ulcers for recurrent bleeding in spite of maximal endoscopic control and profound acid suppression using high dose intravenous infusion of proton pump inhibitor; to characterize the nature of bleeding arteries in severely bleeding peptic ulcers and determine the efficacy of angiographic embolization in the prevention of recurrent bleeding and to establish safety profile of angiographic embolization as an early elective treatment to bleeding peptic ulcers.", - "NCTID": "NCT01142180" - }, - { - "brief_title": "A Study Comparing High Dose Omeprazole Infusion Against Scheduled Second Endoscopy for Bleeding Peptic Ulcer", - "phase": "Phase 3", - "drugs": "['Intravenous omeprazole infusion', 'Scheduled second endoscopy']", - "drugs_list": [ - "Intravenous omeprazole infusion", - "Scheduled second endoscopy" - ], - "diseases": "['Peptic Ulcer Hemorrhage']", - "diseases_list": [ - "Peptic Ulcer Hemorrhage" - ], - "enrollment": "240.0", - "inclusion_criteria": "inclusion criteria: \n\n all consecutive patients admitted for peptic ulcer bleeding (including bleeding anastomotic ulcers) with emergency endoscopy done in 24 hours after admission with Forrest type Ia, Ib, and IIa, IIb \n\n age 15 - 90 years \n\n Written consent available \n\n ", - "exclusion_criteria": ": \n\n ulcer bleeding not controlled in first endoscopy \n\n Bleeding from malignant ulcer or tumor \n\n Bleeding from Dieulafoy lesion/ angiodysplasia \n\n Bleeding from injection sclerotherapy ulcer \n\n Patient with ASA category 5", - "brief_summary": "A prospective randomized study to compare the adjunctive use of high dose omeprazole infusion against scheduled second endoscopy in prevention of peptic ulcer rebleeding after therapeutic endoscopy.", - "NCTID": "NCT00164931" - }, - { - "brief_title": "Famotidine Compared With Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion", - "phase": "Phase 4", - "drugs": "['pantoprazole vs famotidine']", - "drugs_list": [ - "pantoprazole vs famotidine" - ], - "diseases": "['Peptic Ulcer/Erosions']", - "diseases_list": [ - "Peptic Ulcer/Erosions" - ], - "enrollment": "161.0", - "inclusion_criteria": "inclusion criteria: \n\n upper GIB or dyspepsia due to peptic ulcers / erosions while receiving low-dose aspirin with a daily dose ranging from 80 mg to 320 mg \n\n endoscopy revealed a gastric or duodenal ulcers of 3 mm or more in diameter with unequivocal depth, or more than 5 erosions in the stomach or duodenum \n\n they required continuous low-dose aspirin for the secondary prevention of coronary heart disease, peripheral vascular disease and ischemic stroke or transient ischemic attacks \n\n 18 years old or older. \n\n ", - "exclusion_criteria": ": \n\n concurrent erosive or ulcerative esophagitis \n\n pyloric stenosis \n\n previous gastric or duodenal surgery other than oversewing of a perforation \n\n thrombocytopenia \n\n renal failure with estimated creatinine clearance less than 10 ml / min \n\n active cancer \n\n known allergic to aspirin, famotidine or pantoprazole \n\n pregnancy, lactation, child-bearing potential in the absence of contraception \n\n psychosomatic disorder \n\n planned co-prescription of nonsteriodal anti-inflammatory drugs corticosteriod, or anticoagulant \n\n disorders that might modify the absorption of study drugs", - "brief_summary": "Low-dose aspirin can prevent cerebral and cardiovascular accidents in individuals with symptomatic atherothrombotic disease, but its use is frequently limited by gastrointestinal side effects.~The position of H2-receptor antagonists as a step-down therapy after healing of peptic ulcer or erosions by proton pump inhibitor is unclear.~The objective of this randomized, double blinded control study was to compare the efficacy of high-dose famotidine with pantoprazole in the prevention of recurrent dyspeptic or complicated ulcer/ erosions in patients taking low-dose aspirin", - "NCTID": "NCT00843063" - }, - { - "brief_title": "The Selection Criteria for the Second-look Endoscopy Among Patients With Bleeding Peptic Ulcers", - "phase": "", - "drugs": "['esomeprazole or pantoprazole', 'Endoscopic hemostasis']", - "drugs_list": [ - "esomeprazole or pantoprazole", - "Endoscopic hemostasis" - ], - "diseases": "['Peptic Ulcer Hemorrhage']", - "diseases_list": [ - "Peptic Ulcer Hemorrhage" - ], - "enrollment": "316.0", - "inclusion_criteria": "inclusion criteria: \n\n Bleeding peptic ulcers with major stigmata of recent hemorrhage \n\n All of these major SRH are treated by local injection of diluted epinephrine 1:10000 with or without combined therapy with a heater probe, argon plasma coagulation, band ligation, or hemoclip therapy \n\n ", - "exclusion_criteria": ": \n\n Bleeding due to tumor or cancer \n\n Bleeding due to the presence of a Dieulafoy lesion \n\n Ulcer bleeding due to mechanical factors (i.e., gastrostomy tube induction) \n\n Proton pump inhibitors use within one week before enrollment \n\n Failure to establish hemostasis under gastroscopy \n\n Hypersensitivity to esomeprazole, pantoprazole, or any component of the formulation \n\n Previously participated in the study", - "brief_summary": "The purpose of this prospective study is to identify risk factors which could predict poor fading of SRH or early recurrent bleeding of peptic ulcer hemorrhage after successful endoscopic hemostasis and high-dose PPI infusion. These risk factors will be the selection criteria for patients who are indicated to receive second-look endoscopy.", - "NCTID": "NCT02197039" - }, - { - "brief_title": "Comparison of the Effects of Gelatine Versus Balanced Crystalloid Solution for Volume Therapy", - "phase": "", - "drugs": "['Gelofusine\u00ae B. Braun', 'Ringerfundin \u00ae B. Braun']", - "drugs_list": [ - "Gelofusine\u00ae B. Braun", - "Ringerfundin \u00ae B. Braun" - ], - "diseases": "['Hemorrhage, Surgical', 'Hip Replacement, Total', 'Thrombocytopathy']", - "diseases_list": [ - "Hemorrhage", - "Surgical", - "Hip Replacement", - "Total", - "Thrombocytopathy" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n patient scheduled for elective hip replacement surgery \n\n age between 19-85 years \n\n signed informed consent \n\n ", - "exclusion_criteria": ": \n\n informed consent not signed \n\n traumatic hip fracture \n\n anemia (hemoglobin level < 100 g/l) \n\n allergy to study drug and/or multiple allergies \n\n chronic heart failure with LVEF < 30% \n\n shock states \n\n coagulopathy \n\n thrombocytopenia \n\n thrombocytopathy \n\n chronic kidney disease with oliguria \n\n chronic antiplatelet drug medications", - "brief_summary": "The purpose of the study is to determine whether volume therapy with a solution of gelatine has negative impact on coagulation, platelet function, renal function in comparison with crystaloid solution (Ringerfundin).", - "NCTID": "NCT02461329" - }, - { - "brief_title": "PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers", - "phase": "Phase 4", - "drugs": "['Lansoprazole', 'Famotidine']", - "drugs_list": [ - "Lansoprazole", - "Famotidine" - ], - "diseases": "['Peptic Ulcer']", - "diseases_list": [ - "Peptic Ulcer" - ], - "enrollment": "228.0", - "inclusion_criteria": "inclusion criteria: \n\n A history of H. pylori-negative idiopathic peptic ulcers, defined as \n\n No exposure to aspirin, NSAIDs or drugs of unknown nature including traditional Chinese medicine within the 4 weeks before hospitalization; \n\n Biopsies taken during endoscopy must be negative for both the urease test and histology for H. pylori in the absence of acid suppressive therapy; and \n\n No other causes of ulceration identified. \n\n Endoscopically confirmed ulcer healing \n\n Age >18 years old \n\n Informed consent \n\n ", - "exclusion_criteria": ": \n\n Concomitant steroid or anticoagulant \n\n Concomitant use of NSAIDs, aspirin or COX2 inhibitors \n\n Previous gastric surgery \n\n Requirement of maintenance PPI (e.g. reflux oesophagitis) \n\n Advanced comorbidity (defined as ASA 4 or above) or active malignancy \n\n Subjects who are pregnant or lactating, or is intending to become pregnant before, during, or within 1 month after participating in this study \n\n Subjects who have known hypersensitivity or allergies to any component of lansoprazole or famotidine. \n\n Subject who has current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition", - "brief_summary": "The aim of this study is to compare the efficacy of a proton pump inhibitor (lansoprazole) and a histamine-2 receptor antagonist (famotidine) in preventing recurrent ulcer bleeding in patients with a history of H. pylori-negative idiopathic peptic ulcers.", - "NCTID": "NCT01180179" - }, - { - "brief_title": "Phase II Trial of Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer", - "phase": "Phase 2", - "drugs": "['chemoradiotherapy', 'thalidomide', 'without thalidomide']", - "drugs_list": [ - "chemoradiotherapy", - "thalidomide", - "without thalidomide" - ], - "diseases": "['Esophageal Cancer']", - "diseases_list": [ - "Esophageal Cancer" - ], - "enrollment": "180.0", - "inclusion_criteria": "inclusion criteria: \n\n cytologically or histologically confirmed esophageal carcinoma \n\n age of 20 -80 \n\n Karnofsky performance status \u2265 70 \n\n no treatments prior to enrollment \n\n at least one measurable lesion on CT, MRI or esophageal barium exam \n\n normal functions of heart, lung, liver, kidney and bone marrow \n\n blood exams qualified for chemotherapy, which included hemoglobulin \u22659 g/dl, neutrophil \u22651.5\u00d7109/L and platelet (PLT) \u2265100\u00d7109/L, creatinine \u22641.5 UNL \n\n informed consent signed \n\n ", - "exclusion_criteria": ": \n\n prior treatments of chemotherapy or irradiation \n\n poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable \n\n contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis \n\n participating in other clinical trials \n\n pregnancy, breast feeding, or not adopting birth control \n\n drug or alcohol addiction, uncontrolled epileptic seizure, or psychotic with no ability of self control \n\n coexisted morbidities that investigators believed not suitable for chemoradiation", - "brief_summary": "The purpose of this study is to down-regulate VEGF expression in esophageal cancer patients by thalidomide, so to improve their chemoradiotherapy effect. Patients with esophageal cancer receiving chemoradiotherapy were divided into different sub-group according to dynamic change of their VEGF level,and those showed increased or unchanged VEGF were added thalidomide at random. Efficacy and side effect of thalidomide combined with chemoradiotherapy were evaluated, and at the same time, activity of thalidomide on esophageal cancer and its clinical safely were assessed.", - "NCTID": "NCT01551641" - } - ], - "2": [ - { - "brief_title": "Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Upper Gastrointestinal Bleeding']", - "diseases_list": [ - "Upper Gastrointestinal Bleeding" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Established diagnosis of acute upper gastrointestinal bleeding, confirmed by presence of hematemesis/ coffee ground vomiting, melena, as well as other clinical or laboratory evidence of acute blood loss from the upper gastrointestinal tract \n\n Written informed consent provided prior the start of participation in the study. \n\n ", - "exclusion_criteria": ": \n\n Subjects who are unwilling or unable to provide informed consent.", - "brief_summary": "The purpose of this study is to determine and analyse the incidence, severity, risk factors and routine management of acute drug-induced upper gastrointestinal bleeding (UGIB) in the population of Russian patients", - "NCTID": "NCT01155401" - }, - { - "brief_title": "Effectiveness Study of the BioVac Direct Suction Device in Upper Gastrointestinal Bleeding", - "phase": "", - "drugs": "['BioVac Direct Suction Device', 'Standard Endoscopy Suction']", - "drugs_list": [ - "BioVac Direct Suction Device", - "Standard Endoscopy Suction" - ], - "diseases": "['Gastrointestinal Hemorrhage']", - "diseases_list": [ - "Gastrointestinal Hemorrhage" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria \n\n Patients presenting with fresh blood hematemesis, coffee ground emesis, or melena \n\n Patients with hematochezia and hypotension (systolic blood pressure < 90 mm Hg) or tachycardia (heart rate > 110 beats per minute) \n\n ", - "exclusion_criteria": " \n\n Identification of a bleeding source within the first 5 minutes of the upper endoscopy or no blood seen in the upper GI tract as these patients do not require additional suctioning. \n\n Age < 18. \n\n No endoscopy was performed. \n\n Endoscopy previously performed for current episode of UGIB. \n\n Patients unable to consent and who do not have a substitute decision maker.", - "brief_summary": "Upper endoscopy is performed for upper gastrointestinal bleeding (bleeding in the esophagus, stomach, or part of the duodenum) to identify and potentially treat the cause of bleeding. However, blood clots often make visualization difficult during endoscopy. The current practice is to try to wash off and suction up these blood clots with the endoscope. However, this is often not successful due to blood clots blocking the suction channel.~A new device has been approved by Health Canada that attaches to the endoscope and helps prevent blockage. It is believed that this device will help doctors suck out blood clots and potentially improve visualization, identification of the cause of bleeding, and possibly health outcomes, although this has never been proven. The purpose of the this clinical trial is to test whether the device works and whether it can help patients with this type of bleeding.", - "NCTID": "NCT02150941" - }, - { - "brief_title": "Effect of High-dose Oral Rabeprazole on Recurrent Bleeding After the Endoscopic Treatment of Bleeding Peptic Ulcers", - "phase": "Phase 4", - "drugs": "['omeprazole sodium IV', 'Rabeprazole']", - "drugs_list": [ - "omeprazole sodium IV", - "Rabeprazole" - ], - "diseases": "['Peptic Ulcer Hemorrhage']", - "diseases_list": [ - "Peptic Ulcer Hemorrhage" - ], - "enrollment": "106.0", - "inclusion_criteria": "inclusion criteria: \n\n Bleeding peptic ulcer: Among patients suspected to have upper GI bleeding based on hematemesis or melena, those with peptic ulcers(Forrest I, IIa and IIb) in whom active bleeding, non-bleeding visible vessels and fresh blood clots are observed on upper GI endoscopy performed within 24 hours after the hospitalization \n\n patients who achieved primary hemostasis with endoscopic hemostasis procedure via upper GI endoscopy \n\n ", - "exclusion_criteria": ": \n\n Patients who refuse endoscopic procedure \n\n Patients with complications from gastric ulcer that require operative treatment prior to upper GI endoscopic treatment(e.g., gastric outlet obstruction, peptic ulcer perforation) \n\n Pregnancy \n\n Patients with serious concurrent diseases such as malignant tumors or end-stage diseases \n\n History of previous gastrectomy or vagotomy \n\n Known hypersensitivity to proton pump inhibitors \n\n Elderly patients \n\n Epilepsy", - "brief_summary": "This study is conducted to compare and evaluate the effect of administering a high-dose intravenous proton pump inhibitors or high-dose oral Rabeprazole in preventing recurrent bleeding after the endoscopic treatment of bleeding peptic ulcers.", - "NCTID": "NCT00838682" - }, - { - "brief_title": "Study to Assess the Efficacy and Safety of Somatostatin in the Treatment of Acute Severe Upper Gastrointestinal Bleeding", - "phase": "Phase 2", - "drugs": "['Somatostatin UCB (drug)']", - "drugs_list": [ - "Somatostatin UCB (drug)" - ], - "diseases": "['Peptic Ulcer']", - "diseases_list": [ - "Peptic Ulcer" - ], - "enrollment": "370.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female non-cirrhotic patients at least 18 years old suspected to bleed from PU. \n\n Patients with haematemesis and/or hematochezia and/or melena which have been observed by a member of a clinical team (GP, hospital physician, nurse, ...). \n\n Either, documented signs of hypovolemia related to the current bleeding episode Or, occurrence of symptoms of hypovolemia \n\n ", - "exclusion_criteria": ": \n\n Treatment of the present bleeding episode with somatostatin or its analogues, vasoactive drugs, or endoscopic therapy. \n\n Any treatment with PPIs (IV or per os) within the last 48 hours preceding randomisation. \n\n Treatment (endotherapy or pharmacotherapy) for upper gastrointestinal ulcer bleeding in the last 30 days. \n\n Deficient haemostasis (platelets < 40 x 109/l, international normalised ratio of the prothrombin time > 1.5 (or prothrombin time < 70%), or activated partial thromboplastin time > 40 seconds (or according to the normal ranges validated, from local lab)) \n\n Anticoagulant therapy (vitamin K antagonists or heparin including LMW heparins) \n\n Terminal stage illness in which endoscopy is contraindicated", - "brief_summary": "To assess the efficacy and safety of the early administration of somatostatin in infusion during 72 hours plus 2 boluses, compared to placebo in the control of acute severe UGIB with suspicion of PUB.", - "NCTID": "NCT00152399" - }, - { - "brief_title": "Survey of Non-Variceal Upper Gastro Intestinal Bleeding in Vietnamese Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Re-bleeding in NVUGIB']", - "diseases_list": [ - "Re-bleeding in NVUGIB" - ], - "enrollment": "1044.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult patients (>=18yrs) admitted to the hospital, or inpatients admitted for another reason, presenting with overt non-variceal upper GI bleed manifesting as hematemesis/coffee ground vomiting, melena, hematochezia... \n\n Evidence that an upper GI endoscopy was performed \n\n ", - "exclusion_criteria": ": \n\n GI bleeding not from NVUGIB", - "brief_summary": "The main aim of the study is to describes the outcomes of patients with Upper Gastrointestinal Bleed (UGIB) in a real-life setting. Additionally analyse assessed predictors of outcome, including the impact of hemostatic endoscopic and pharmacologic therapies.", - "NCTID": "NCT01292915" - }, - { - "brief_title": "Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed.", - "phase": "", - "drugs": "['Erythromycin', 'Metoclopromide']", - "drugs_list": [ - "Erythromycin", - "Metoclopromide" - ], - "diseases": "['Upper Gastrointestinal Bleeding']", - "diseases_list": [ - "Upper Gastrointestinal Bleeding" - ], - "enrollment": "4.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult patients (18-80) \n\n who are admitted to the ICU for hematemesis, or coffee ground emesis \n\n ", - "exclusion_criteria": ": \n\n Patients younger than 18 yrs old or older than 80 yrs \n\n Patients who refuse to consent to be in our study \n\n Pregnant patients \n\n Prior use of prokinetics in the last 48 hours \n\n History of cardiac arrhythmia \n\n Allergy to erythromycin or metoclopromide \n\n Patients with QT prolongation (query 7) \n\n -", - "brief_summary": "This is a study comparing the effect of erythromycin or metoclopramide, 2 prokinetic drugs (Drugs which are known to speed up the emptying of the stomach or in other words to move the blood out of the stomach faster) given before endoscopy to patients with upper Gastrointestinal bleeding compared to patients who will not receive either of these medications before their endoscopy.", - "NCTID": "NCT02017379" - }, - { - "brief_title": "Second-look Endoscopy in High Risk Patients After Endoscopic Hemostasis to Their Bleeding Peptic Ulcers Improves Their Outcomes", - "phase": "", - "drugs": "['epinephrine injection or heater probe or hemoclips', 'Observation only']", - "drugs_list": [ - "epinephrine injection or heater probe or hemoclips", - "Observation only" - ], - "diseases": "['Ulcer Bleeding']", - "diseases_list": [ - "Ulcer Bleeding" - ], - "enrollment": "157.0", - "inclusion_criteria": "inclusion criteria: \n\n Age >=18 \n\n Informed consent obtained \n\n Successful endoscopic hemostasis \n\n Risk Score >= 5 \n\n ", - "exclusion_criteria": ": \n\n Age < 18 \n\n Pregnancy \n\n Incomplete endoscopic haemostasis -", - "brief_summary": "Bleeding peptic ulcer is a common medical emergency. Endoscopic treatment stops bleeding in those actively bleeding from their peptic ulcers, reduces further bleeding, transfusion, surgery and deaths. After initial endoscopic control of bleeding, approximately 10% of them will develop recurrent bleeding. Mortality rate in this group of patients is at least 4 fold higher. In the few who need surgery, mortality approaches 30%. Prevention of further bleeding is therefore a major treatment objective. Currently the investigators use a high dose infusion of proton pump inhibitor (PPI) for 72 hours to render gastric pH neutral. In a previous randomized trial, the investigators showed that the rate of bleeding in 30 days was around 7% with such an approach. In a small subgroup of high risk patients defined by presentation with shock and ulcers > 2 cm in size, 1 in 6 would re-bleed. An alternate strategy is to select those at especially high risk of further bleeding and repeat endoscopic treatment the next morning. The investigators have shown that persistence of major bleeding stigmata, i.e. a visible vessel, during a second endoscopy predicts further bleeding. It is therefore logical that by repeating endoscopic treatment the next morning, the investigators can prevent further bleeding and possibly surgery and deaths. The current study proposes to develop a score to identify those at risk of further bleeding after endoscopy. The investigators used a historical cohort with carefully collected clinical data to derive a risk score. In this derivation phase of 939 patients, the investigators have developed a 9 point risk score which consists of the following parameters (Age>60, Male sex, ulcer>2cm, posterior bulbar in location, spurting or Forrest Ia bleeding and admission hemoglobin of < 8 g/dl). Using AUROC and Youden J statistics, a score of 5 or above has been shown to highly predictive of further bleeding. The score will then be validated in a prospective cohort of patients with bleeding peptic ulcers. In the final phase of this study, the investigators propose a randomized controlled trial to test the hypothesis that a second look endoscopy with treatment in selected high risk patients can further reduce bleeding and improve their outcomes. After endoscopic hemostasis to their bleeding peptic ulcers, patients are risk stratified based on the score. Those with a score of 5 or more are randomized to receive the standard treatment (a high dose PPI infusion) or a second look endoscopy with treatment in addition to PPI infusion. The primary outcome to the trial is further significant clinical bleeding.", - "NCTID": "NCT02352155" - }, - { - "brief_title": "Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage", - "phase": "Phase 3", - "drugs": "['Pantoprazole']", - "drugs_list": [ - "Pantoprazole" - ], - "diseases": "['Peptic Ulcer Hemorrhage']", - "diseases_list": [ - "Peptic Ulcer Hemorrhage" - ], - "enrollment": "149.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients must be men or non-pregnant women at least 18 years of age \n\n Patients who present with a gastric or duodenal ulcer \n\n ", - "exclusion_criteria": ": \n\n Patients with ulcer appearance of clean base (non-oozing, non-spurting) or flat pigmented spot; adherent clots not removed by irrigation \n\n Patients presenting with active bleeding and/or NBVV at 2 or more separate sites \n\n Patients with any severe concomitant diseases, eg, end stage liver or renal disease, or unstable cardiovascular, pulmonary, renal, hepatic, or gastrointestinal diseases", - "brief_summary": "The purpose of this study is to evaluate the efficacy and safety of intravenous pantoprazole in the prevention of rebleeding in patients with bleeding peptic ulcer disease after successful endoscopic hemostatic therapy.", - "NCTID": "NCT00040495" - }, - { - "brief_title": "Sublingual Administration of PPI", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Gastric or Duodenal Ulcer']", - "diseases_list": [ - "Gastric or Duodenal Ulcer" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with peptic ulcer disease \n\n Age: 20-75 years old \n\n Patients who submitted informed consent \n\n ", - "exclusion_criteria": ": \n\n Peptic ulcer disease with spurting and oozing \n\n Shock, hypotension, pregnancy \n\n Gastrointestinal malignancy", - "brief_summary": "Compare 24-hour intragastric pH and therapeutic effectiveness of proton pump inhibitor (PPI) among different administration methods: per oral (PO), intravenous (IV), and sublingual (SL).", - "NCTID": "NCT01926600" - }, - { - "brief_title": "Oral Versus IV Proton Pump Inhibitor in High-risk Bleeding Peptic Ulcers After Endoscopic Hemostasis", - "phase": "Phase 3", - "drugs": "['Pantoprazole (Pantoloc)', 'Lansoprazole (Takepron OD)']", - "drugs_list": [ - "Pantoprazole (Pantoloc)", - "Lansoprazole (Takepron OD)" - ], - "diseases": "['Peptic Ulcers']", - "diseases_list": [ - "Peptic Ulcers" - ], - "enrollment": "190.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 18 \n\n Confirmed ulcer bleeding with Forrest Ia, Ib, IIa \n\n Endoscopic hemostasis achieved by combined endoscopic hemostasis \n\n Informed consent obtained \n\n ", - "exclusion_criteria": ": \n\n No consent \n\n Unsuccessful endoscopic treatment \n\n Upper GI malignancy \n\n History of subtotal gastrectomy \n\n Bleeding tendency, platelet count < 80x109/L, prothrombin time INR >1.5 \n\n Myocardial infarction or cerebrovascular accident within one week \n\n Ulcer bleeding because of mechanical factors (such as, induction of NG tube) \n\n Malignancy or other advanced disease with a life expectancy of < 6 months \n\n IV PPI > 40mg within 24hrs before enrollment \n\n Decompensated liver cirrhosis \n\n Requiring dialysis \n\n Pregnant or lactating women \n\n History of allergy or severe side effects to lansoparzole or pantoprazole", - "brief_summary": "Endoscopic hemostasis has been documented by a number of clinical studies to be effective in decreasing rebleeding, need for emergency surgery, and hospitalization days. Studies showed adjuvant treatment with proton pump inhibitor (PPI) after initial endoscopic hemostasis reduced recurrent ulcer bleeding. However, the optimal dose and route of adjuvant PPI therapy remains controversial. A recent study demonstrated frequent oral PPI offered similar acid control as currently recommended intravenous infusion PPI did in patients with bleeding ulcers. The investigators hypothesize that an frequent oral PPI treatment has similar benefit as proton pump inhibitor infusion in patient with bleeding ulcers after combined endoscopic hemostasis.", - "NCTID": "NCT01182597" - }, - { - "brief_title": "Argon Plasma Coagulation for Bleeding Peptic Ulcers", - "phase": "Phase 4", - "drugs": "['Argon plasma coagulation', 'Distilled water']", - "drugs_list": [ - "Argon plasma coagulation", - "Distilled water" - ], - "diseases": "['Bleeding Ulcers']", - "diseases_list": [ - "Bleeding Ulcers" - ], - "enrollment": "116.0", - "inclusion_criteria": "inclusion criteria: \n\n (i) over 20 years of age and (ii) patients with high-risk peptic ulcer bleeding. \n\n ", - "exclusion_criteria": ": \n\n (i) the presence of another possible bleeding site (eg, gastroesophageal varix, gastric cancer, reflux esophagitis); (ii) coexistence of actively severe ill diseases (eg, septic shock, stroke, myocardial infarction, surgical abdomen); (iii) treatment with an anticoagulant (eg, warfarin); (iv) pregnancy; (v) the presence of operated stomach or; (vi) refusal to participate in the study.", - "brief_summary": "Background:~A second endoscopic method added to injection therapy is recommended for high-risk bleeding peptic ulcers. Many endoscopic devices have been proved as useful hemostatic instruments, whereas the hemostatic efficacy of argon plasma coagulation (APC) has not been widely investigated.~Aim:~This study was designed to know whether additional APC treatment could influence the hemostatic efficacy after endoscopic injection therapy in treating high-risk bleeding ulcers.~Methods:~From October 2010 to January 2012, eligible patients who had high-risk bleeding ulcers were admitted to our hospital. They prospectively randomly underwent either APC therapy plus distilled water injection or distilled water injection alone. Pantoprazole infusion was conducted during the fasting period after endoscopy and orally for 8 weeks to encourage ulcer healing. Episodes of rebleeding were retreated with endoscopic combination therapy. Patients who did not benefit from retreatment underwent emergency surgery or transarterial embolization (TAE).", - "NCTID": "NCT02241044" - }, - { - "brief_title": "Comparative Study of Autologous Blood Injection Versus Diluted Epinephrine in Treating Actively Bleeding Gastroduodenal Ulcers", - "phase": "", - "drugs": "['Epinephrine', 'Blood']", - "drugs_list": [ - "Epinephrine", - "Blood" - ], - "diseases": "['Blood, Injection, Injury Type Phobia', 'Gastrointestinal Ulcer Haemorrhage', 'Adverse Reaction to Epinephrine']", - "diseases_list": [ - "Blood", - "Injection", - "Injury Type Phobia", - "Gastrointestinal Ulcer Haemorrhage", - "Adverse Reaction to Epinephrine" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n all adult patients with gastroduodenal ulcer \n\n ", - "exclusion_criteria": ": \n\n Patients with non ulcer bleeding. \n\n Patients with malignancy. \n\n Patients with bleeding disorders or under coagulation therapy. \n\n Patients with known allergy to epinephrine.", - "brief_summary": "Endoscopic injection of autologous blood can control bleeding from gastroduodenal ulcers.", - "NCTID": "NCT01560702" - }, - { - "brief_title": "Esomeprazole Versus Pantoprazole to Prevent Peptic Ulcer Rebleeding", - "phase": "Phase 4", - "drugs": "['Esomeprazole', 'Pantoprazole']", - "drugs_list": [ - "Esomeprazole", - "Pantoprazole" - ], - "diseases": "['Peptic Ulcer']", - "diseases_list": [ - "Peptic Ulcer" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n aged more than 18 years \n\n undergo emergent endoscopy within 24 hours of presentation \n\n have peptic ulcers in the gastroesophageal junction, stomach, or duodenum \n\n high-risk stigmata of peptic ulcers: Forrest classification IA \n\n IIB \n\n endoscopic hemostasis by thermocoagulation or clip placement \n\n ", - "exclusion_criteria": ": \n\n pregnant or lactating \n\n written informed consent not obtained \n\n initial endoscopic hemostasis fail \n\n bleeding tendency (platelet count < 50\u00d7109/L, prolonged prothrombin time for more than 3 seconds, or were taking anticoagulants) \n\n PPI use within 14 days of enrollment \n\n comorbid with severe hepatic or renal insufficiency (serum total bilirubin more than 5 mg/dL, serum creatinine more than 5 mg/dL, or under dialysis) \n\n bleeding gastric cancers", - "brief_summary": "The aim of this study is to compare the clinical effectiveness of intravenous esomeprazole and pantoprazole in preventing recurrent bleeding in the patients with high-risk bleeding peptic ulcers after successful standard endoscopic hemostasis.", - "NCTID": "NCT00881413" - }, - { - "brief_title": "Dopamine and Norepinephrine in Shock Patients", - "phase": "Phase 3", - "drugs": "['dopamine versus norepinephrine']", - "drugs_list": [ - "dopamine versus norepinephrine" - ], - "diseases": "['Shock']", - "diseases_list": [ - "Shock" - ], - "enrollment": "1679.0", - "inclusion_criteria": "inclusion criteria: \n\n Mean arterial pressure less than 70 mmHg or systolic pressure less than 100 mmHg persisting despite adequate fluid loading (in example with at least 1000 mL crystalloid or 500 ml colloid) unless central venous pressure (CVP) or pulmonary artery occluded pressure (PAOP) are elevated (e.g. CVP> 12 mmHg or PAOP > 14 mmHg). \n\n ", - "exclusion_criteria": ": \n\n Serious arrhythmia such as rapid atrial fibrillation (> 160/min) or ventricular tachycardia. \n\n Brain death. \n\n Open label administration of dopamine, norepinephrine, epinephrine or phenylephrine for more than 4hours.", - "brief_summary": "The purpose of this study is to compare the efficacy of dopamine and norepinephrine, two commonly used vasopressor agents, in the treatment of shock.", - "NCTID": "NCT00314704" - }, - { - "brief_title": "The Therapeutic Role of Intravenous Albumin Administration for Peptic Ulcer Bleeding Patients With Hypoalbuminemia", - "phase": "Phase 4", - "drugs": "['Human albumin', 'Omeprazole']", - "drugs_list": [ - "Human albumin", - "Omeprazole" - ], - "diseases": "['Peptic Ulcer Bleeding', 'Hypoalbuminemia']", - "diseases_list": [ - "Peptic Ulcer Bleeding", - "Hypoalbuminemia" - ], - "enrollment": "91.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical presentations of melena, hematochezia, or hematemesis \n\n Gastroscopy confirmed peptic ulcers and major stigmata of recent hemorrhage \n\n A Rockal score \u2265 6 \n\n ", - "exclusion_criteria": ": \n\n Gastric or esophageal, or duodenal tumor bleeding \n\n Ulcer due to mechanical factors \n\n Warfarin use \n\n Failure to establish hemostasis under gastroscopy \n\n Hypersensitivity to omeprazole, esomeprazole, albumin or any component of the formulation.", - "brief_summary": "To test whether intravenous albumin can decrease the rebleeding rate or shorten the duration of hospitalization in patients with peptic ulcer bleeding and hypoalbuminemia.", - "NCTID": "NCT01822600" - }, - { - "brief_title": "Multicenter Validation on Predicting Mortality for Patients With Bleeding Peptic Ulcers", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Bleeding Peptic Ulcer']", - "diseases_list": [ - "Bleeding Peptic Ulcer" - ], - "enrollment": "785.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients presented with bleeding peptic ulcers \n\n Age > 18 year old \n\n Informed consent for the study and OGD \n\n ", - "exclusion_criteria": ": \n\n Unable or refuse to give consent \n\n Onset more than 7 days \n\n Pregnancy", - "brief_summary": "This study aimed to validate CU prediction model on mortality for patients with high risk bleeding peptic ulcers after therapeutic endoscopy.", - "NCTID": "NCT02245802" - }, - { - "brief_title": "Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding", - "phase": "Phase 4", - "drugs": "['pantoprazole', 'pantoprazole']", - "drugs_list": [ - "pantoprazole", - "pantoprazole" - ], - "diseases": "['Peptic Ulcer Hemorrhage']", - "diseases_list": [ - "Peptic Ulcer Hemorrhage" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients were accepted for endoscopic therapy if a peptic ulcer with active bleeding, a non-bleeding visible vessel (NBVV) or an adherent blood clot at the ulcer base was observed within 24 hours of hospital admission. \n\n ", - "exclusion_criteria": ": \n\n If patients were pregnant \n\n Did not obtain initial hemostasis with endoscopic injection of epinephrine \n\n Did not give written informed consent \n\n Had bleeding tendency (platelet count < 50\u00d7109/L, serum prothrombin < 30% of normal, or were taking anticoagulants), uremia.", - "brief_summary": "A large dose of PPI is effective in preventing peptic ulcer rebleeding. The investigators hypothesize that 40 mg/q6h pantoloc is equivalent to 8mg/h pantoloc in preventing rebleeding.", - "NCTID": "NCT00731601" - }, - { - "brief_title": "Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus", - "phase": "", - "drugs": "['Endoscopic Translumenal Omental Patch']", - "drugs_list": [ - "Endoscopic Translumenal Omental Patch" - ], - "diseases": "['Peptic Ulcer']", - "diseases_list": [ - "Peptic Ulcer" - ], - "enrollment": "7.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients presenting with clinical diagnosis of a perforated viscus who are scheduled to undergo surgical intervention \n\n Surgical candidate for endoscopic, laparoscopic, or open procedure \n\n Age > 21 \n\n Informed written consent \n\n ", - "exclusion_criteria": ": \n\n Prior gastric or duodenal surgery \n\n Prior total abdominal colectomy or transverse colectomy \n\n Prior omentectomy or omental flaps \n\n Known perforation site other than stomach or duodenum \n\n Patients with contra-indications for laparoscopy \n\n Patients with contraindications for endoscopy \n\n Upper gastrointestinal anatomy that would preclude endoscopic therapy \n\n Coagulopathy or thrombocytopenia \n\n Pregnant patients \n\n Patients <21 years of age \n\n Prisoners \n\n Patients found at surgery to have disease processes other than perforated peptic ulcer disease will be asked for permission to record their data for comparison", - "brief_summary": "This study is being done to see if a new approach to repair perforated ulcers in the stomach (holes in the stomach) or the first part of the intestine is possible. Traditionally, either open operations (large single incision) or laparoscopic operations (multiple small camera-guided incisions) have been used to repair perforated ulcers. Over the last ten years, some surgeons have used endoscopic equipment to assist them with performing the procedure. It is unknown if perforated ulcer repair can be done using an endoscope as the main instrument (a flexible tube with a video camera inserted into the stomach through your esophagus) to patch or plug the perforation. We will patch the perforation using a standard method which uses tissue from outside the stomach. A laparoscopic camera will also be used to assist our view. This study is intended to be a feasibility study to demonstrate the endoscopic technique can be safely performed~Hypothesis: The primary outcome is successful completion of the procedure.", - "NCTID": "NCT01080326" - }, - { - "brief_title": "Hemospray Versus the Combined Conventional Technique for Endoscopic Hemostasis of Bleeding Peptic Ulcers : A Pilot Study", - "phase": "", - "drugs": "['Hemospray', 'Combined Conventional Technique']", - "drugs_list": [ - "Hemospray", - "Combined Conventional Technique" - ], - "diseases": "['Bleeding Peptic Ulcers']", - "diseases_list": [ - "Bleeding Peptic Ulcers" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Peptic ulcer with high-risk stigmata of recent hemorrhage (Forrest class IA, IB, IIA and IIB) \n\n ", - "exclusion_criteria": ": \n\n Patients younger than 21 years of age \n\n Refusal to participate in study \n\n Contraindicated for endoscopy \n\n Pregnant or lactating patients \n\n Bleeding secondary to non-peptic ulcer source \n\n Patients requiring mechanical ventilation \n\n Patients with acute coronary syndrome", - "brief_summary": "Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), a new adsorptive nanopowder hemostatic agent for endoscopic treatment of high-risk bleeding peptic ulcers, provides significant ease of administration compared to the combined conventional technique of saline-adrenaline injection with mechanical clip or heater probe applications. The Hemospray powder is easily applied on ulcers at difficult endoscopic positions and ulcers with fibrotic bases, where the combined conventional technique has limited efficacy. Building up on preliminary work from small single-arm studies, the investigators aim to establish the efficacy and safety of Hemospray in treating bleeding peptic ulcers in comparison with the combined conventional technique. The investigators propose a pilot study to establish our centre's feasibility of performing a prospective, randomized, parallel group trial, which compares the efficacy of Hemospray with the combined conventional technique, in the endoscopic treatment of high-risk bleeding peptic ulcers. Patients with high-risk bleeding peptic ulcers will be treated with Hemospray to determine its initial hemostasis rate (defined as endoscopically verified cessation of bleeding for at least 5 minutes after endoscopic treatment), rebleeding rate (recurrent hemorrhage during a 4-week period following the initial hemostasis) and its safety profile.", - "NCTID": "NCT02088385" - }, - { - "brief_title": "Resolution Endoclips Vs Epinephrine Injection and Heater Probe", - "phase": "Phase 3", - "drugs": "['Resolution clip (endo-clipping device)']", - "drugs_list": [ - "Resolution clip (endo-clipping device)" - ], - "diseases": "['Peptic Ulcer Hemorrhage']", - "diseases_list": [ - "Peptic Ulcer Hemorrhage" - ], - "enrollment": "103.0", - "inclusion_criteria": "inclusion criteria: \n\n Age >16 , can obtain written consent \n\n Ulcers that require endoscopic therapy with SRH: Forrest I a, Ib, II a and II b \n\n ", - "exclusion_criteria": ": \n\n Moribund patients with terminal malignancy \n\n Pregnancy \n\n Intercurrent ulcer complication that prevents treatment and surgery becomes mandatory such as bulbar stenosis and ulcer perforation", - "brief_summary": "To compare the efficacy of a novel endoscopic clipping device(Resolution Clip\u2122) and conventional epinephrine injection and heater probe thermocoagulation in control of peptic ulcer bleeding and prevention of recurrent bleeding", - "NCTID": "NCT00165009" - }, - { - "brief_title": "Peptic Ulcer Perforation Study", - "phase": "", - "drugs": "['An optimized perioperative course']", - "drugs_list": [ - "An optimized perioperative course" - ], - "diseases": "['Peptic Ulcer Perforation']", - "diseases_list": [ - "Peptic Ulcer Perforation" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients surgically treated for benign peptic ulcer perforation \n\n ", - "exclusion_criteria": ": \n\n Age < 18 years \n\n Pregnant and breastfeeding women \n\n Malign ulcer perforation", - "brief_summary": "The objective of this study is to implement an optimized perioperative course for patients surgically treated for peptic ulcer perforation in order to improve the outcome for these patients.~The optimized perioperative course consists of a number of interventions carried out before, during and after surgery.", - "NCTID": "NCT00624169" - } - ] - }, - { - "patient_id": "sigir-20152", - "patient": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", - "0": [ - { - "brief_title": "Cell Mediated Immunity for Secondary Prophylaxis in CMV SOT Patients", - "phase": "", - "drugs": "['Valganciclovir or Ganciclovir']", - "drugs_list": [ - "Valganciclovir or Ganciclovir" - ], - "diseases": "['Cytomegalovirus Viraemia']", - "diseases_list": [ - "Cytomegalovirus Viraemia" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult solid organ transplant (SOT) recipient on at least one immunosuppressive medication \n\n Starting therapy for new onset asymptomatic CMV viremia OR starting therapy for new onset CMV disease \n\n CMV viral load \u2265 1000 IU/mL \n\n ", - "exclusion_criteria": ": \n\n Known ganciclovir-resistant CMV \n\n Known intolerance to valganciclovir or ganciclovir \n\n Unable to comply with protocol", - "brief_summary": "This study will evaluate whether a test for Cytomegalovirus (CMV) specific cell-mediated immunity can be used to determine whether patients who complete a course of therapy for CMV viremia need secondary antiviral prophylaxis. Subjects that have negative CMV CMI will receive antiviral prophylaxis for 2 months and those with positive CMV CMI will have their prophylaxis stopped.", - "NCTID": "NCT02370758" - }, - { - "brief_title": "Cytomegalovirus Reactivation in Non Immunocompromised Patients Undergoing Cardiac Surgery", - "phase": "", - "drugs": "['Blood test']", - "drugs_list": [ - "Blood test" - ], - "diseases": "['Cardiac Surgery']", - "diseases_list": [ - "Cardiac Surgery" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients admitted for cardiac surgery. \n\n Age 18 and above. \n\n ", - "exclusion_criteria": ": \n\n 1. Immunosuppressed patients including: HIV, active cancer, biological chemotherapy, steroid use equivalent to prednisone dosage above 1 mg/Kg a day, post organ transplantation.", - "brief_summary": "We hypothesized that the stress of cardiac surgery and cardiopulmonary bypass can cause reactivation of a latent CMV infection and that reactivation might be more prevalent in patients with complicated post-operative course. The study aims are:~To study whether cardiac surgery is a trigger for latent CMV reactivation and to compare reactivation rate between sub groups of patient with complicated post-operative course and non complicated post operative course.~To study the relationship between expression IL28 SNP rs12979860 and the risk of CMV replication in the non immunocompromised patient undergoing cardiac surgery.", - "NCTID": "NCT02527291" - }, - { - "brief_title": "Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient", - "phase": "", - "drugs": "['Ganciclovir']", - "drugs_list": [ - "Ganciclovir" - ], - "diseases": "['Cytomegalovirus Infections', 'Cytomegalovirus Retinitis', 'HIV Infections']", - "diseases_list": [ - "Cytomegalovirus Infections", - "Cytomegalovirus Retinitis", - "HIV Infections" - ], - "enrollment": "", - "inclusion_criteria": "", - "exclusion_criteria": " \n\n Co-existing Condition: \n\n Patients with the following are excluded: \n\n Cytomegalovirus (CMV) disease who meet the criteria for a treatment IND protocol, or other clinical studies, including controlled clinical studies of anticytomegalovirus therapy in peripheral CMV retinitis in patients with AIDS. \n\n Mild to moderate CMV infections who fail to meet the severity criteria. CMV syndrome (i.e., cytopenia, increased liver enzymes, fever, viremia, viruria) is not considered immediately life-threatening. \n\n Transplant patients in whom trial reduction of immunosuppressive drug treatment is feasible. \n\n Children with congenital or neonatal CMV where there is not a documented primary or acquired immunodeficiency. \n\n Hypersensitivity to acyclovir or ganciclovir. \n\n Receiving antimetabolite treatment that cannot be discontinued. \n\n Concurrent Medication: \n\n Excluded: \n\n Antimetabolites. \n\n Alkylating agents. \n\n Nucleoside analogs (topical ophthalmics are permitted). \n\n Interferon. \n\n Foscarnet. \n\n Cytokines. \n\n Patients with the following are excluded: \n\n Cytomegalovirus (CMV) infection who meet the criteria for a treatment IND protocol, or other clinical studies, including controlled clinical studies of anticytomegalovirus therapy in peripheral CMV retinitis in patients with AIDS. \n\n Mild to moderate CMV infections who fail to meet the severity criteria. CMV syndrome (i.e., cytopenia, increased liver enzymes, fever, viremia, viruria) is not considered immediately life-threatening. \n\n Transplant patients in whom trial reduction of immunosuppressive drug treatment is feasible. \n\n Children with congenital or neonatal CMV where there is not a documented primary or acquired immunodeficiency. \n\n Hypersensitivity to acyclovir or ganciclovir. \n\n Receiving antimetabolite treatment that cannot be discontinued. \n\n Patients must qualify as follows: \n\n Previously enrolled in compassionate use study (ICM 1257/1257A) or have terminated from another Syntex ganciclovir study. \n\n Diagnosis of AIDS and life-threatening Cytomegalovirus (CMV) infection. \n\n Diagnosis of other immunodeficiencies other than AIDS, with life-threatening or sight-threatening CMV disease.", - "brief_summary": "To make intravenous (IV) ganciclovir available to immunocompromised patients with life-threatening or sight-threatening Cytomegalovirus (CMV) infection, where the symptoms of the disease are too severe to allow admission to a controlled clinical study of ganciclovir therapy. To determine the safety and tolerance of 2 - 3 weeks induction course of ganciclovir IV followed by a maintenance course of ganciclovir IV for an indefinite duration. To tabulate the patient's clinical response.", - "NCTID": "NCT00002025" - }, - { - "brief_title": "Viral Infections in BAL and Bronchial Biopsies of Stable COPD Patients", - "phase": "", - "drugs": "['BRONCHOSCOPIC PROCEDURE']", - "drugs_list": [ - "BRONCHOSCOPIC PROCEDURE" - ], - "diseases": "['HRV and RSV Presence in the Lungs of Stable COPD Patients.']", - "diseases_list": [ - "HRV and RSV Presence in the Lungs of Stable COPD Patients." - ], - "enrollment": "53.0", - "inclusion_criteria": "inclusion criteria: \n\n stable COPD,indication for bronchoscopic procedure \n\n ", - "exclusion_criteria": ": \n\n atopic history, asthma, extensive pleural effusions, bronchiectasis, immunosuppression due to chemotherapy or systemic corticosteroids and all the contraindications of the bronchoscopic procedures", - "brief_summary": "Background: The presence of low-grade viral infection in the airways of patients with stable chronic obstructive pulmonary disease (COPD) could potentially have implications in the pathogenesis and progression of the disease, but previous studies have reported very different rates of human rhinovirus (HRV) and respiratory syncytial virus (RSV) genome detection in nasal and sputum samples. However, no study has investigated the presence of these viruses directly in the lungs by bronchoalveolar lavage (BAL) and bronchial biopsies. This study aimed to investigate whether HRV and RSV are present in the lungs of stable COPD patients by performing BAL and bronchial biopsies, and relate their presence with disease severity.~Methods: Consecutive patients with stable COPD and control subjects, who underwent diagnostic (e.g., lung cancer) and/or therapeutic (e.g., hemoptysis) fibreoptic bronchoscopy in a university hospital in Athens, Greece, were enrolled. The collected BAL and bronchial biopsies during bronchoscopy were subsequently processed for HRV and RSV RNA detection with real-time polymerase chain reaction (PCR). More specifically, the nucleocapsid gene and 5\u0384 non-coding region were searched for RSV and HRV detection, respectively.", - "NCTID": "NCT02622009" - }, - { - "brief_title": "A Study to Identify and Characterise Bacteria Causing Chronic Cough Among Children in United Kingdom", - "phase": "", - "drugs": "['Cough swab', 'Oropharyngeal swab', 'Nasopharyngeal swabs', 'Blood sample', 'Bronchoscopy/ bronchoalveolar lavage samples', 'Data collection']", - "drugs_list": [ - "Cough swab", - "Oropharyngeal swab", - "Nasopharyngeal swabs", - "Blood sample", - "Bronchoscopy/ bronchoalveolar lavage samples", - "Data collection" - ], - "diseases": "['Infections, Respiratory Tract']", - "diseases_list": [ - "Infections", - "Respiratory Tract" - ], - "enrollment": "19.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects who the investigator believes that parent(s)/ legally acceptable representative can and will comply with the requirements of the protocol. \n\n A male or female child between, and including, six to 72 months of age at the time of enrolment. \n\n Written informed consent obtained from the parent(s)/ legally acceptable representative of the subject. \n\n No antibiotic therapy within four weeks prior to the visit. \n\n No cystic fibrosis or known major immunodeficiency such as agammaglobulinaemia, T cell deficiency or Human Immunodeficiency Virus / Acquired Immune Deficiency Syndrome. \n\n No documented evidence or suspicion of gastroesophageal reflux disease. \n\n No evidence of an upper viral respiratory infection four weeks prior to the visit. \n\n In addition, all subjects regarded as 'cases' must satisfy all the following criteria at study entry: \n\n Persistent cough greater than eight weeks. \n\n No response to five-day prednisolone treatment. \n\n Chest X-ray showing no evidence of a lobar pneumonia or gross structural abnormality. \n\n In addition, all subjects regarded as 'controls' must satisfy the following criteria at study entry: \n\n No respiratory symptoms four weeks prior to the visit. \n\n No documented evidence or suspicion of lung disease upon physical examination. \n\n ", - "exclusion_criteria": ": \n\n Concurrently participating in another study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. \n\n Use of any investigational or non-registered product within 30 days prior to study procedures, or planned use during the study period. \n\n Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. \n\n Child in care.", - "brief_summary": "The purpose of this study is to investigate the role of Haemophilus influenzae and other bacteria in causing chronic cough, through a direct comparison of chronic cough cases and healthy controls recruited from paediatric respiratory clinics in the United Kingdom.", - "NCTID": "NCT01292213" - }, - { - "brief_title": "Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever", - "phase": "Phase 2", - "drugs": "['ibuprofen', 'ibuprofen']", - "drugs_list": [ - "ibuprofen", - "ibuprofen" - ], - "diseases": "['Post Bronchoscopy Fever']", - "diseases_list": [ - "Post Bronchoscopy Fever" - ], - "enrollment": "64.0", - "inclusion_criteria": "inclusion criteria: \n\n under twelve years of age \n\n all patients undergoing bronchoscopy and bronchoalveolar lavage \n\n ", - "exclusion_criteria": ": \n\n children with immune deficiency \n\n allergy to NSAIDS \n\n previous exacerbation of asthma due to NSAIDS \n\n fever on the day of the examination \n\n current antibiotic treatment", - "brief_summary": "Scientific background: Bronchoscopy is a procedure commonly performed in the management of persistent respiratory illness. In the last decades this exam has become a routine and safe procedure even in children and there are few side-effects. However, one known side effect is transient fever and even high fever a few hours after the bronchoscopy. This side effect is not dangerous but very uncomfortable for the patients and it would be interesting to try to reduce this phenomena. This fever is due to a release of cytokines during the broncho-alveolar lavage procedure and not to sepsis. In a previous study a single dose of dexamethasone was shown to prevent the fever post bronchoscopy with no apparent detriment to the child. It is well known that steroids are immunosuppressive. Even though the post-bronchoscopy fever is not caused by an infection, it seems preferable to use other anti-inflammatory drugs to fight this very inconvenient side effect.~Ibuprofen (Nurofen*) is known as an effective medication to reduce fever in infectious illnesses and is even considered as superior to paracetamol. It has no immunosuppressive effect and is usually well tolerated by children with very few side effects when taken in the normal therapeutic dose of 10mg/Kg. The investigators postulate that a dose of Nurofen prior to bronchoscopy could significantly reduce fever post bronchoscopy.", - "NCTID": "NCT00954200" - }, - { - "brief_title": "Allogeneic Virus-Specific Cytotoxic T-Lymphocytes(CTL), Persistent/Recurrent Viral Infection Post-HSCT (EAP CHALLAH)", - "phase": "", - "drugs": "['Trivirus-Specific CTLs']", - "drugs_list": [ - "Trivirus-Specific CTLs" - ], - "diseases": "['EBV Infection', 'CMV Infection', 'Adenoviral Infection']", - "diseases_list": [ - "EBV Infection", - "CMV Infection", - "Adenoviral Infection" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow, peripheral blood stem cells or single or double umbilical cord blood. \n\n CMV, adenovirus or EBV infection persistent despite standard therapy \n\n For CMV infection \n\n Patients with CMV disease: defined as the demonstration of CMV by biopsy specimen from visceral sites (by culture or histology) or the detection of CMV by culture or direct fluorescent antibody stain in bronchoalveolar lavage fluid in the presence of new or changing pulmonary infiltrates OR \n\n Failure of antiviral therapy: defined as the continued presence of pp65 antigenemia (>1+ cell/100,000 cells) or DNAemia (as defined by reference lab performing PCR assay but usually >400 copies/ml) after at least 7 days of antiviral therapy OR \n\n Relapse after antiviral therapy defined as recurrence of either pp65 antigenemia or DNAemia after at least 2 weeks of antiviral therapy \n\n For CMV infection, standard therapy is defined as 7 days therapy with Ganciclovir, Foscarnet or Cidofovir for patients with disease or recurrence after 14 days therapy \n\n For EBV infection \n\n EBV infection is defined as: \n\n Biopsy proven lymphoma with EBV genomes detected in tumor cells by immunocytochemistry or in situ PCR OR \n\n Or clinical or imaging findings consistent with EBV lymphoma and elevated EBV viral load in peripheral blood. \n\n For EBV infection, standard therapy is defined as rituximab given at 375mg/m2 in patients for 1-4 doses with a CD20+ve tumor \n\n Failure is defined as \n\n There was an increase or less than 50% response at sites of disease for EBV lymphoma OR \n\n There was a rise or a fall of less than 50% in EBV viral load in peripheral blood or any site of disease \n\n For adenovirus infection or disease \n\n Adenovirus infection is defined as the presence of adenoviral positivity as detected by PCR, DAA or culture from ONE site such as stool or blood or urine or nasopharynx OR \n\n Adenovirus disease will be defined as the presence of adenoviral positivity as detected by culture from two or more sites such as stool or blood or urine or nasopharynx \n\n Standard therapy is defined as 7 days therapy with Cidofovir (if renal function permits this agent to be given). \n\n Failure is defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease as measured by PCR or any other quantitative assay). \n\n Patients with multiple CMV, EBV or Adenovirus infections are eligible given that each infection is persistent despite standard therapy as defined above. Patients with multiple infections with one persistent infection and one controlled infection are eligible to enroll. \n\n Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day prednisone. \n\n Written informed consent and/or signed assent line from patient, parent or guardian. \n\n ", - "exclusion_criteria": ": \n\n Received ATG, or Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening for enrollment. \n\n Uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. \n\n Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. \n\n Received donor lymphocyte infusion (DLI) within 28 days. \n\n Active acute GVHD grades II-IV. \n\n Active and uncontrolled relapse of malignancy \n\n Pregnant or lactating in female patients, if applicable (childbearing potential who have received a reduced intensity conditioning regimen).", - "brief_summary": "Subjects have a type of blood cell cancer, other blood disease or a genetic disease for which they received a stem cell transplant. After transplant while the immune system grows back the subjects have an infection with one or more of three viruses - Epstein Barr virus (EBV), cytomegalovirus (CMV) or adenovirus - that has persisted or come back despite standard therapy.~Adenovirus is a virus that causes symptoms of a common cold normally but can cause serious life-threatening infections in patients who have weak immune systems. It usually affects the lungs and can cause a very serious pneumonia, but it can also affect the gut, the liver, the pancreas and the eyes.~CMV is a virus that can also cause serious infections in patients with suppressed immune systems. It usually affects the lungs and can cause a very serious pneumonia, but it can also affect the intestinal tract, the liver and the eyes. Approximately 2/3 of normal people harbor this virus in their body. In healthy people CMV rarely causes any problems because the immune system can keep it under control. If the subject and/or the subject's donor are positive for CMV, s/he is at risk of developing CMV disease while his/her immune system is weak post transplant.~EBV is the virus that causes glandular fever or kissing disease. It is also normally controlled by a healthy immune system, but when the immune system is weak, it can cause fevers, enlarged lymph nodes and sometimes develop into a type of cancer called lymphoma.~This treatment with specially trained T cells (called CTLs) has had activity against these viruses when the cells are made from the transplant donor. However, as it takes 2-3 months to make the cells, that approach is not practical when the subject already has an infection. We want to find out if we can use CTLs which have already been made from another donor that match the subject and his/her donor as closely as possible and if the CTLs will last in the body and have activity against these viruses.~In a recent study these cells were given to 50 patients with viral infections post transplant and over 70% had a complete or partial response. The purpose of this study is to make CTL lines leftover from that previous study available to patients with viral infections that have not responded to standard treatments.~These virus-specific CTLs are an investigational product not approved by the FDA.", - "NCTID": "NCT01945619" - }, - { - "brief_title": "Emergency Use of Adoptive Immunotherapy With CMV-Specific T Cells After Donor Bone Marrow Transplant of an Infant With Immunodeficiency Syndrome and CMV Infection", - "phase": "", - "drugs": "['therapeutic allogeneic lymphocytes', 'allogeneic bone marrow transplantation', 'total-body irradiation']", - "drugs_list": [ - "therapeutic allogeneic lymphocytes", - "allogeneic bone marrow transplantation", - "total-body irradiation" - ], - "diseases": "['Infection', 'Precancerous/Nonmalignant Condition']", - "diseases_list": [ - "Infection", - "Precancerous/Nonmalignant Condition" - ], - "enrollment": "", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Adenosine deaminase-deficient severe combined immunodeficiency syndrome (ADA-SCIDs) \n\n CMV interstitial pneumonia based on the constellation of clinical and radiological findings \n\n PATIENT CHARACTERISTICS: \n\n Female \n\n Oxygen desaturation (pulse oximetry 85% on room air) \n\n Abnormal chest radiograph \n\n No CMV retinitis \n\n PRIOR CONCURRENT THERAPY: \n\n Prior ganciclovir and foscarnet sodium", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Collecting the T cells from a donor and transplanting them into a patient may be effective treatment for immunodeficiency syndrome and CMV infection.~PURPOSE: This clinical trial is studying the emergency use of adoptive immunotherapy with CMV-specific T cells after donor bone marrow transplant of an infant with immunodeficiency syndrome and CMV infection.", - "NCTID": "NCT00547235" - }, - { - "brief_title": "A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)", - "phase": "Phase 3", - "drugs": "['CMV hyperimmune globulin', 'Placebo']", - "drugs_list": [ - "CMV hyperimmune globulin", - "Placebo" - ], - "diseases": "['Congenital Cytomegalovirus Infection', 'Maternal Cytomegalovirus Infection']", - "diseases_list": [ - "Congenital Cytomegalovirus Infection", - "Maternal Cytomegalovirus Infection" - ], - "enrollment": "399.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of primary maternal CMV infection on the basis of one of the following: \n\n A positive CMV Immunoglobulin M (IgM) antibody and low-avidity maternal CMV Immunoglobulin G (IgG) antibody screen \n\n Evidence of maternal seroconversion with development of CMV IgG antibody following a prior negative CMV screen \n\n Gestational age at randomization no later than 23 weeks 6 days based on clinical information and evaluation of the earliest ultrasound; or no later than 27 weeks 6 days for women with a positive IgM, negative IgG initially screened before 23 weeks who are rescreened after 2-4 weeks and have evidence of IgG seroconversion. \n\n Singleton pregnancy. A twin pregnancy reduced to singleton (either spontaneously or therapeutically) before 14 weeks by project gestational age is acceptable. \n\n ", - "exclusion_criteria": ": \n\n Maternal CMV infection pre-dating pregnancy as defined by a high IgG avidity index or a positive IgG in the presence of a negative IgM. \n\n Known hypersensitivity to plasma or plasma derived products \n\n Planned termination of pregnancy \n\n Known major fetal anomalies or demise \n\n Maternal Immunoglobulin A (IgA) deficiency \n\n Planned use of immune globulin, ganciclovir, or valganciclovir \n\n Maternal renal disease (most recent pre-randomization serum creatinine \u2265 1.4 mg/dL; all women must have serum creatinine measured during the pregnancy and prior to randomization) \n\n Maternal immune impairment (e.g., HIV infection, organ transplant on anti-rejection medications) \n\n Findings on pre-randomization ultrasound suggestive of established fetal CMV infection (cerebral ventriculomegaly, microcephaly, cerebral or intra-abdominal calcifications, abnormalities of amniotic fluid volume, echogenic bowel or ascites). Abnormally low amniotic fluid volume is defined as no fluid prior to 14 weeks or maximum vertical pocket < 2 cm on or after 14 weeks gestation. Abnormally high amniotic fluid volume is defined as > 10 cm. \n\n Positive fetal CMV findings from culture (amniotic fluid) or PCR. \n\n Congenital infection with rubella, syphilis, varicella, parvovirus or toxoplasmosis diagnosed by serology and ultrasound or amniotic fluid testing. \n\n Intention of the patient or of the managing obstetricians for the delivery to be outside a Maternal-Fetal Medicine Units Network (MFMU) Network center \n\n Participation in another interventional study that influences fetal or neonatal death \n\n Unwilling or unable to commit to 2 year follow-up of the infant", - "brief_summary": "Cytomegalovirus (CMV) is a common virus that usually presents with few if any side effects. When first infected, some people may have symptoms similar to mononucleosis (i.e., fatigue, weakness, fever, swollen glands). Most people in the United States are infected during childhood or as adults if they work around children. Pregnant women, who have not been infected with CMV in the past and become infected during pregnancy (i.e. a primary infection), may cause their babies to get infected with CMV. Babies that are infected may develop permanent disabilities including hearing loss and a small portion will die from the infection.~Currently it is not routine practice to screen pregnant women for CMV infection. Additionally, there is no agreement about how to evaluate and manage pregnant women infected with CMV for the first time. There is also no evidence that treatment is beneficial for the baby.~The purpose of this research study is to determine whether treating pregnant women who have a primary CMV infection with CMV antibodies will reduce the number of babies infected with CMV.", - "NCTID": "NCT01376778" - }, - { - "brief_title": "Validation of Lophius Kits T-Track\u00ae CMV and T-Track\u00ae EBV in Hemodialysis Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Renal Failure Chronic Requiring Dialysis']", - "diseases_list": [ - "Renal Failure Chronic Requiring Dialysis" - ], - "enrollment": "133.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient being hemodialysis-dependent due to end-stage kidney disease \n\n Male or female patient at least 18 years of age \n\n Written informed consent \n\n ", - "exclusion_criteria": ": \n\n Patient requires ongoing dosing with a systemic immunosuppressive drug \n\n Patient has received immunosuppressive therapy within the last three month \n\n Patient is known to be positive for HIV or suffering from chronic hepatitis infections \n\n Patient has significant uncontrolled concomitant infections or other unstable medical conditions that could interfere with the study objectives \n\n Patient has any form of substance abuse, psychiatric disorder or condition that, in the opinion of the investigator may invalidate communication with the investigator", - "brief_summary": "Cell-mediated immunity (CMI) and in particular T cells play a critical role in the rejection of transplanted organs. Thus, in transplant recipients a life-long and individualized immunosuppressive medication is required to avoid graft rejection. However, a too weak suppression of CMI causes acute and chronic graft damage leading to transplant loss, whereas a too potent suppression of CMI supports opportunistic infections and reactivation of persistent viruses.~One of the biggest challenges in the field of transplantation is to provide a personalized immunosuppressive and antiviral therapy based on reliable assessment and monitoring of CMI. This could lead to a reduction of graft rejections and virus reactivations in transplant recipients.~With the development of both assays T-Track\u00ae CMV and T-Track\u00ae EBV, Lophius Biosciences GmbH has implemented its novel proprietary T-activation technology for an improved assessment of the functionality of CMI in cytomegalovirus (CMV)- and/or Epstein-Barr virus (EBV)-seropositive individuals. In contrast to other existing systems the Lophius assays open up the opportunity to characterize the functionality of CMI as an entire network.~The planned clinical multicenter study aims to verify the suitability of the two assays for a reliable assessment of the functionality of CMI.~Hemodialysis patients have been identified as an appropriate patient cohort for investigating the clinical sensitivity of the Lophius assays as these patients closely resemble kidney transplant recipients prior to an immunosuppressive therapy.~The determination of the functional CMI in the course of an immunosuppressive treatment may in future enable physicians to optimize the individual immunosuppressive and antiviral therapy in transplant recipients to reduce the risk of rejection as well as virus reactivations and associated diseases.", - "NCTID": "NCT02630537" - }, - { - "brief_title": "Proportion of CMV Seropositive Kidney Transplant Recipients Who Will Develop a CMV Infection When Treated With an Immunosuppressive Regimen Including Everolimus and Reduced Dose of Cyclosporine Versus an Immunosuppressive Regimen With Mycophenolic Acid and Standard Dose of Cyclosporine A", - "phase": "Phase 4", - "drugs": "['Everolimus', 'mycophenolic acid']", - "drugs_list": [ - "Everolimus", - "mycophenolic acid" - ], - "diseases": "['Transplantation Infection', 'Cytomegalovirus Infection']", - "diseases_list": [ - "Transplantation Infection", - "Cytomegalovirus Infection" - ], - "enrollment": "186.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 18 years. \n\n End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation. \n\n Patient seropositive for CMV (confirmed within two weeks post-transplant) and having received an allograft from a CMV seropositive or seronegative donor. \n\n Receiving a kidney transplant from a deceased or living donor with compatible ABO blood type. \n\n Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study and two months later the discontinuation of the test drug. \n\n Total ischemia time below 36 hours. \n\n Capable of understanding the purpose and risks of the study. \n\n Fully informed and having given written informed consent (signed Informed Consent has been obtained). \n\n Affiliation to the social security regimen \n\n ", - "exclusion_criteria": ": \n\n CMV seronegative patient. \n\n Historical or current TGI (French equivalence of calculated PRA) > 85 % \n\n Presence of historical or current anti-HLA donor specific antibodies \n\n Patient who received anti-CMV therapy within the past 30 days prior to screening. \n\n Receiving or having previously received an organ transplant other than a kidney. \n\n Receiving a graft from a non-heart-beating donor. \n\n Patient known to be positive for Human Immunodeficiency Virus (HIV), Hepatitis B (HBV; HBs Ag positive) or Hepatitis C (HCV; anti-HCV Ab positive).elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels \u2265 2 times the upper value of the normal range of the investigational site or receiving a graft from a hepatitis C or B positive donor. \n\n Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer. \n\n Known allergy or intolerance to everolimus, valganciclovir, ganciclovir, mycophenolic acid, basiliximab, corticosteroids, or cyclosporine A or any of the product excipients. \n\n Severe hyperlipidemia defined by: total cholest\u00e9rol \u2265 9,1 mmol/L (\u2265 350 mg/dL) et/ou triglyc\u00e9rides \u2265 8,5 mmol/l (\u2265 750 mg/dL) in spite an adequate medication. \n\n Patient has adequate hematological post-transplant defined as: \n\n Absolute neutrophil count (ANC) > 1000 cells/\u03bcL. \n\n Platelet count > 50,000 cells/\u03bcL. \n\n Hemoglobin > 8.0 g/dL. \n\n Requiring initial therapy with induction immunosuppressive antibody preparations, such as anti-thymocyte globulins or rituximab or IVIG. \n\n Currently participating in another clinical trial investigating drugs. Observational studies are not considered as an ", - "brief_summary": "Cytomegalovirus (CMV) infection is the most frequent opportunistic viral infection after transplantation. It is associated with an increased incidence of acute rejection and lower graft and patient survivals. The goal of this study is to demonstrate that an immunosuppressive regimen associating everolimus and reduced dose of cyclosporine A can prevent acute rejection episodes as efficiently as standard regimen but also efficiently reduce the incidence of CMV infection at 6 months post-transplantation.", - "NCTID": "NCT02328963" - }, - { - "brief_title": "Clinical Validation of Lophius Biosciences Kit T-Track\u00ae CMV in Kidney Transplant Recipients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cytomegalovirus', 'Kidney Transplantation', 'CMV Specific Immune Response']", - "diseases_list": [ - "Cytomegalovirus", - "Kidney Transplantation", - "CMV Specific Immune Response" - ], - "enrollment": "97.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient receiving a kidney graft \n\n Recipient being CMV-seropositive prior transplantation and receiving a graft from either a CMV-seropositive or from a seronegative donor (intermediate risk groups, D+/R+; D-/R+,) \n\n Patient scheduled to follow the preemptive antiviral strategy with oral valganciclovir or intravenous ganciclovir after transplantation \n\n Patient receiving the standard triple immunosuppressive regimen (CNI, MMF/MPA or mTOR inhibitors, steroids), with or without induction therapy (except ATG) as start therapy after transplantation \n\n Male or female patient at least 18 years of age \n\n Written informed consent \n\n ", - "exclusion_criteria": ": \n\n Patient is scheduled for the optional visit 1, but requires ongoing treatment with a systemic immunosuppressive drug already prior to kidney transplantation (except induction therapy other than ATG) \n\n Patient receiving ATG as induction therapy \n\n Patient is known to be positive for HIV or suffering from chronic hepatitis infections \n\n Patient has significant uncontrolled concomitant infections or other unstable medical conditions before transplantation that could interfere with the study objectives \n\n Patient is unable to comply with the visit schedule in the protocol \n\n Patient has any form of substance abuse, psychiatric disorder or condition that, in the opinion of the investigator may invalidate communication with the investigator", - "brief_summary": "This study aims to validate whether Lophius Biosciences Kit T-Track\u00ae CMV is suitable to assess the functionality of CMV-specific cell-mediated immunity (CMI) and to determine a protective cut-off value for CMV reactivations/disease in kidney transplant recipients.~Lophius kit T-Track\u00ae CMV represents a highly standardized and sensitive diagnostic tool to assess the functionality of a network of clinically relevant CMV-reactive effector cells. It is based on the stimulation of peripheral blood mononuclear cells (PBMC) with urea-formulated immunodominant CMV proteins, pp65 and IE-1, and the subsequent quantification of CMV-specific CMI (spot forming colonies) using a highly sensitive IFN-\u03b3 ELISpot.", - "NCTID": "NCT02083042" - }, - { - "brief_title": "The Optimization of Mycoplasm Pneumonia Antibiotic Therapy", - "phase": "", - "drugs": "['Moxifloxacin', 'Cephalosporins and azithromycin']", - "drugs_list": [ - "Moxifloxacin", - "Cephalosporins and azithromycin" - ], - "diseases": "['Mycoplasma Pneumonia']", - "diseases_list": [ - "Mycoplasma Pneumonia" - ], - "enrollment": "208.0", - "inclusion_criteria": "inclusion criteria: \n\n Confirmed community acquired pneumonia \n\n 60ys\u2265age\u226518 ys \n\n Respiratory symptom (cough accompanied by little or no sputum) \n\n New infiltration showed by chest radiology(x-ray or CT) \n\n Lung signs was not obvious \n\n White blood cell<10,000/mm3 \n\n Without underlying diseases or mild \n\n ", - "exclusion_criteria": ": \n\n Age<18ys or >60ys \n\n Pregnancy or breast-feeding \n\n Over one week after the onset of symptoms \n\n HIV infection \n\n Recent 90-day hospitalized history(length of stay greater than 2 days) \n\n Live in nursing homes or rehabilitation hospitals \n\n Taken macrolides or quinolones medicines before enrollment", - "brief_summary": "Mycoplasma pneumoniae, an important pathogen of community acquired pneumonia,are becoming more and more resistant to macrolide. The study aim is to optimize anti-infection therapy.", - "NCTID": "NCT01259141" - }, - { - "brief_title": "Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients", - "phase": "Phase 3", - "drugs": "['maribavir', 'placebo']", - "drugs_list": [ - "maribavir", - "placebo" - ], - "diseases": "['Cytomegalovirus Infections']", - "diseases_list": [ - "Cytomegalovirus Infections" - ], - "enrollment": "681.0", - "inclusion_criteria": "inclusion criteria: \n\n Allogeneic stem cell transplant recipient \n\n Recipient or donor CMV seropositive \n\n Have transplant engraftment \n\n Able to swallow tablets \n\n ", - "exclusion_criteria": ": \n\n CMV organ disease \n\n HIV infection \n\n Use of other anti-CMV therapy post-transplant", - "brief_summary": "The purpose of this research study is to investigate whether or not maribavir is safe and effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who have had a stem cell transplant.", - "NCTID": "NCT00411645" - }, - { - "brief_title": "PTH - Preemptive Treatment for Herpesviridae", - "phase": "Phase 4", - "drugs": "['Aciclovir', 'Ganciclovir', 'Placebo']", - "drugs_list": [ - "Aciclovir", - "Ganciclovir", - "Placebo" - ], - "diseases": "['Viral Pneumonia']", - "diseases_list": [ - "Viral Pneumonia" - ], - "enrollment": "317.0", - "inclusion_criteria": "inclusion criteria: \n\n mechanical ventilation > 96 hrs and expected duration of mechanical ventilation of at least 2 days \n\n positive blood CMV PCR (500 IU/ml) OR positive oropharyngeal HSV PCR \n\n age > 18 years \n\n informed consent \n\n negative pregnancy test \n\n ", - "exclusion_criteria": ": \n\n < 18 years \n\n Receiving ganciclovir or aciclovir or another antiviral agent active against HSV/CMV \n\n Had received antiviral agent active against HSV/CMV during the previous month \n\n Hypersensitivity to aciclovir/ganciclovir \n\n Pregnancy \n\n Breast feeding \n\n Bone marrow failure \n\n Solid organ recipients \n\n Bone marrow recipients \n\n HIV positive patients \n\n Receiving immunosuppressive agents \n\n SAPS II > 75 \n\n Withdrawing/withholding \n\n Neutropenia (< 500 mm3) \n\n Thrombocytopenia (< 25 G/L) \n\n ICU readmission", - "brief_summary": "The aim of this study is to show that a preemptive treatment by ganciclovir (for positive CMV viremia) or aciclovir (for positive HSV oro-pharyngeal PCR) is able to increase the number of ventilator-free days at Day 60.", - "NCTID": "NCT02152358" - }, - { - "brief_title": "Markers of Airway Inflammation in BAL Fluid From Children With Asthma", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "103.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years of age or younger \n\n Scheduled for bronchoscopy at National Jewish Health for persistent asthma, persistent, poorly controlled wheezing, chronic cough, GERD, atelectasis, bronchopulmonary dysplasia, infection. \n\n Consent and assent from parent and patient [if appropriate]. \n\n ", - "exclusion_criteria": ": \n\n Unwillingness to consent/assent to retrieval of BAL fluid for research analysis.", - "brief_summary": "The study compares the biochemical markers in bronchoalveolar lavage samples from asthmatic children to those markers found in non-asthmatic children with other respiratory diseases. The investigators hypothesize that certain markers will be associated specifically with asthma.", - "NCTID": "NCT00838552" - }, - { - "brief_title": "Targeting Oxidative Stress in Chronic Beryllium Disease", - "phase": "Phase 1; Phase 2", - "drugs": "['Mesalamine', 'Placebo']", - "drugs_list": [ - "Mesalamine", - "Placebo" - ], - "diseases": "['Chronic Beryllium Disease']", - "diseases_list": [ - "Chronic Beryllium Disease" - ], - "enrollment": "18.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of chronic beryllium disease based on the criteria below: \n\n History of beryllium exposure, and; \n\n Positive blood and/or bronchoalveolar lavage Beryllium Lymphocyte Proliferation Tests (BeLPT), and; \n\n Biopsy-proven pathologic changes consistent with CBD-non-caseating granulomas and/or mononuclear cell interstitial infiltrates, and; \n\n Positive bronchoalveolar lavage (BAL) BeLPT and > 15% lymphocytes in BAL fluid. \n\n ", - "exclusion_criteria": ": \n\n History of Hepatic disease \n\n History of Renal disease \n\n Hypersensitivity to Pentasa (5-ASA) or salicylates. \n\n Pregnancy \n\n Presence of another disease that may be expected to significantly affect patient mortality (e.g., HIV), severe cor pulmonale); \n\n The use of blood thinners. \n\n Current use of tobacco (smoking or otherwise) in the past 6 months \n\n Patient inability to participate in the study, such as inability to undergo venipuncture and BAL procedures (if undergoing bronchoscopy) that form part of the inclusion/", - "brief_summary": "The purpose of this study is to understand if a drug called mesalamine helps to control inflammation associated with chronic beryllium disease (CBD). We hypothesize that in CBD subjects treated with prednisone, mesalamine treatment will enhance the immunosuppressive effects of prednisone, and thus reduce the immune response to beryllium.", - "NCTID": "NCT01088243" - }, - { - "brief_title": "The Safety and Effectiveness of FIAC in the Treatment of Cytomegalovirus (CMV) in Patients With AIDS", - "phase": "Phase 2", - "drugs": "['Fiacitabine']", - "drugs_list": [ - "Fiacitabine" - ], - "diseases": "['Cytomegalovirus Infections', 'HIV Infections']", - "diseases_list": [ - "Cytomegalovirus Infections", - "HIV Infections" - ], - "enrollment": "78.0", - "inclusion_criteria": "inclusion criteria \n\n Concurrent Medication: \n\n Allowed: \n\n Pentamidine aerosol for prophylaxis of recurrent Pneumocystis carinii pneumonia (PCP) in patients currently receiving such treatment. \n\n Prior Medication: \n\n Allowed: \n\n Zidovudine (AZT) but only if patient has been taking the drug for > 6 weeks at a dose = or < 600 mg/day, and had < 10 percent decrease in hematocrit, neutrophils, and platelets in the last 30 days. Those off AZT must have been off it for > 1 month. \n\n Patients must: \n\n Have documented cytomegalovirus (CMV) viremia or viruria. \n\n Have a diagnosis of HIV infection by ELISA or Western blot. \n\n Be able to participate as an outpatient. \n\n Be ambulatory. \n\n Grade 0 or 1 AIDS Clinical Trial Group toxicity grades for specified laboratory tests. \n\n Be competent to sign informed consent. \n\n Be able to cooperate with the treatment plan and evaluation schedule. \n\n NOTE: \n\n The screening tests must be initiated and completed within 4 weeks prior to the first dose of FIAC. \n\n Concomitant diseases allowed: \n\n Stable mucocutaneous Kaposi's sarcoma. \n\n Superficial or uncomplicated infections such as thrush. \n\n ", - "exclusion_criteria": " \n\n Co-existing Condition: \n\n Patients with the following are excluded: \n\n HIV wasting syndrome (involuntary weight loss > 10 percent of baseline body weight and/or chronic diarrhea or weakness and documented fever for at least 30 days). \n\n Clinical or x-ray evidence of bronchitis, pneumonitis, pulmonary edema, effusion, or suspected active tuberculosis. \n\n Any unstable medical condition including serious cardiovascular, infectious, oncologic, renal, or hepatic condition. \n\n Cytomegalovirus end organ disease. \n\n Kaposi's sarcoma requiring chemotherapy. \n\n Systemic fungal infection requiring amphotericin therapy. \n\n Diagnosis of idiopathic thrombocytopenic purpura (persistent platelet counts < 100000 platelets/mm3 for = or > 3 months). \n\n Patients with the following are excluded: \n\n HIV wasting syndrome. \n\n Clinical or x-ray evidence of bronchitis, pneumonitis, pulmonary edema, effusion, or suspected active tuberculosis. \n\n Any unstable medical condition including serious cardiovascular, infectious, oncologic, renal, or hepatic condition. \n\n Cytomegalovirus (CMV) end organ disease e.g., retinitis, hepatitis, gastroenteritis. \n\n Prior Medication: \n\n Excluded within 4 weeks of study entry: \n\n Zidovudine (AZT). \n\n Acyclovir. \n\n Ganciclovir (DHPG). \n\n Foscarnet. \n\n Interferon. \n\n Other drug with putative anticytomegaloviral activity. \n\n Any immunostimulating drug not specifically allowed.", - "brief_summary": "To find oral doses of FIAC (a pyrimidine nucleoside analog) that are effective in treating cytomegalovirus (CMV) viremia in HIV-infected immunocompromised patients; to determine tolerance and safety of FIAC in this patient population; and to determine pharmacokinetics following multiple doses of FIAC. (An example of another nucleoside analog effective against retroviruses such as HIV is zidovudine (AZT).) CMV infection is a medically significant opportunistic disease in patients with HIV-related infection. The purine nucleoside ganciclovir has been used to treat AIDS patients with CMV disease. Although ganciclovir is useful in treating CMV disease, such treatment is frequently complicated by hematologic (blood) toxicity. Also, treatment is difficult because it requires daily intravenous dosing. Test tube studies show that FIAC and its primary breakdown product FIAU are highly and specifically active against several viruses including CMV. A single-dose, pharmacokinetic (blood level) study showed that FIAC, when taken orally, is readily absorbed into the bloodstream, and most of it is converted to FIAU.", - "NCTID": "NCT00000981" - }, - { - "brief_title": "Shedding, Immunogenicity and Safety of Quadrivalent Live Intranasal Influenza Vaccine (QLAIV) in HIV-infected Children and Young Adults", - "phase": "Phase 2", - "drugs": "['Quadrivalent Live Attenuated Influenza Vaccine']", - "drugs_list": [ - "Quadrivalent Live Attenuated Influenza Vaccine" - ], - "diseases": "['Human Immunodeficiency Virus (HIV)']", - "diseases_list": [ - "Human Immunodeficiency Virus (HIV)" - ], - "enrollment": "101.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 2-25 \n\n Only supposed to get one dose of vaccine for upcoming influenza season \n\n No viral respiratory symptoms at time of immunization \n\n HIV-infected group: must have: \n\n HIV-infection documented by 2 tests such as positive serology, positive HIV DNA or positive HIV RNA; \n\n must thave a CD4>25% or 500, or \n\n must have CD4>15% or 200 and be on HAART \n\n Healthy controls: no major medical problems affecting the immune system \n\n Recruited among: \n\n HIV-unifected clients of the Children's Immunodeficiency Program(CHIP), \n\n Children's Hospital Colorado Child Health Clinic and Adolescent Clinics. \n\n ", - "exclusion_criteria": ": \n\n History of: \n\n reactive airway disease, \n\n recurrent wheezing, or \n\n asthma \n\n Active wheezing at time of immunization \n\n On any antiviral agents active against influenza (amantadien/rimantadine, zanamavir, oseltamivir) at time of immunization or planned over 21 days of shedding collection \n\n Receipt of IVIG within 3 months prior to enrollment \n\n Plan to receive IVIG during the 4 weeks after immunization \n\n Moderate to severely immunocompromised individual living in the home \n\n Pregnant \n\n Breastfeeding \n\n Plan to start immunosupressive medications or stop HAART over the 4 weeks following immmunization \n\n Temperature > 100F or 37.8C \n\n Rhinorrhea or cough not related to allergies at the time of immunization \n\n History of fungal sinusitis \n\n History of Guillain-Barre Syndrome \n\n Current on antibiotics \n\n Currently taking aspirin \n\n On an investigational drug at the time of immunization or planned over the 28 days of shedding collection \n\n On any experimental medication at time of immunization or planned over 21 days of shedding collection", - "brief_summary": "The goal of this study is to determine if there is a difference in shedding (primary objective) and in immunogenicity and safety (secondary objectives) between HIV-positive and HIV-negative children and young adults who are receiving the quadrivalent live-attenuated influenza vaccine (QLAIV).", - "NCTID": "NCT02474901" - }, - { - "brief_title": "Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients", - "phase": "Phase 3", - "drugs": "['maribavir', 'ganciclovir']", - "drugs_list": [ - "maribavir", - "ganciclovir" - ], - "diseases": "['Cytomegalovirus Infections']", - "diseases_list": [ - "Cytomegalovirus Infections" - ], - "enrollment": "307.0", - "inclusion_criteria": "inclusion criteria: \n\n Orthotopic liver transplant recipient \n\n Donor CMV seropositive / Recipient CMV seronegative \n\n Enrolled within 10 days after liver transplant \n\n Able to swallow tablets \n\n ", - "exclusion_criteria": ": \n\n Multiple organ transplant \n\n HIV infection \n\n CMV disease \n\n Use of other anti-CMV therapy at time of enrollment", - "brief_summary": "The purpose of this research study is to investigate whether or not oral maribavir is safe and effective compared to oral ganciclovir for preventing CMV disease when administered for up to 14 weeks in patients who have had a liver transplant.", - "NCTID": "NCT00497796" - }, - { - "brief_title": "A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy", - "phase": "Phase 1", - "drugs": "['Ganciclovir']", - "drugs_list": [ - "Ganciclovir" - ], - "diseases": "['Cytomegalovirus Retinitis', 'HIV Infections']", - "diseases_list": [ - "Cytomegalovirus Retinitis", - "HIV Infections" - ], - "enrollment": "38.0", - "inclusion_criteria": "inclusion criteria \n\n Concurrent Medication: \n\n Allowed: \n\n Zidovudine (AZT). \n\n AMENDED: 8/8/90 Other available antiretroviral therapy. \n\n Pneumocystis carinii pneumonia (PCP) prophylaxis, either systemic or local (aerosolized). \n\n Chemotherapy for Kaposi's sarcoma. \n\n Systemic therapy for intercurrent opportunistic infections. \n\n Acyclovir or other treatment of Herpes simplex virus (HSV) or Varicella zoster virus (VZV) infections. \n\n Systemic therapy deemed necessary for appropriate medical management. \n\n Patients must have AIDS and cytomegalovirus (CMV) retinitis in at least one eye, diagnosed by an ophthalmologist and verified by fundoscopy and fundus photography. \n\n ", - "exclusion_criteria": " \n\n Co-existing Condition: \n\n Patients with the following are excluded: \n\n Contraindication to intravitreal injection, including obvious external infection and vitreous hemorrhage. \n\n Medical opacities of cornea, lens, and/or vitreous which precludes fundus photography. \n\n Concurrent Medication: \n\n Excluded: \n\n Prophylactic acyclovir at time of study entry. \n\n Other anticytomegalovirus (CMV) therapy, particularly systemic ganciclovir, foscarnet, or CMV hyperimmune globulin. \n\n Topical ophthalmic medications should be avoided. \n\n Cytomegalovirus (CMV) therapies and chronic acyclovir, including necessary therapies for an intercurrent opportunistic infection. \n\n Patients with the following are excluded: \n\n Contraindication to intravitreal injection, including obvious external infection and vitreous hemorrhage. \n\n Medical opacities of cornea, lens, and/or vitreous which precludes fundus photography.", - "brief_summary": "AMENDED: 04-12-91 Population of patients changed FROM those who are intolerant of systemic therapy with NON-sight-threatening CMV retinitis TO those AIDS patients intolerant of systemic therapy with CMV retinitis.~AMENDED: 8/8/90. Changes made in neutrophils count from < 500 to < 750 cells/mm3. Nonrandomized eyes will not be used for the primary efficacy evaluation.~ORIGINAL DESIGN: To determine the effectiveness and safety of ganciclovir (DHPG) therapy in AIDS patients suffering from active cytomegalovirus (CMV) infection of the retina of the eye (retinitis) when the drug is administered directly into the fluid-filled vitreous cavity of the eye by injection.~CMV retinitis is the most frequently seen opportunistic infection of the eye in AIDS patients, and left untreated can lead to severe visual loss and blindness. While systemic administration of DHPG has been shown to be an effective treatment for CMV retinitis, the chronic administration required may be complicated by decreased blood cell counts (granulocytopenia) which may require discontinuation of treatment. While withholding treatment may allow recovery from the granulocytopenia, interruption of therapy may result in reactivation of the retinitis. Injection of DHPG into the vitreous cavity of the eye may be of benefit to severely neutropenic patients with CMV retinitis.", - "NCTID": "NCT00000673" - }, - { - "brief_title": "Trial of Donor T Cells Sensitized With Pentadecapeptides of the CMV-PP65 Protein for the Treatment of Cytomegalovirus (CMV) Infections Following Allogeneic Hematopoietic Stem Cell Transplants", - "phase": "Phase 1", - "drugs": "['CMV-Peptide-Specific T cells']", - "drugs_list": [ - "CMV-Peptide-Specific T cells" - ], - "diseases": "['Cytomegalovirus Infections']", - "diseases_list": [ - "Cytomegalovirus Infections" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Prior to receiving treatment, some patients may undergo diagnostic and/or other testing of their tissue, if available, to determine if their CMV infected cells are likely to respond to treatment with CMV specific T cells. Alternatively, blood samples may be required for research tests to ascertain that the CMV-specific T-cells do not contain any cells that could react against the patient. These patients will sign a separate pre-treatment consent. If it is determined that a patient will qualify for and might benefit from infusions of CMV CTLs, he/she will go on to sign the standard treatment consent for MSKCC IRB # 05-065 and be enrolled and treated on trial, if all other eligibility criteria are met. \n\n Each patient must satisfy at least one of the following criteria: \n\n The patient must have a clinically documented condition associated with CMV (e.g. interstitial pneumonia, hepatitis, retinitis) or \n\n The patient must have microbiological evidence of CMV viremia or tissue invasion as attested by viral culture, or detection of CMV antigenemia or detection of levels of CMV DNA in blood or body fluids consistent with CMV infection. \n\n The patient's CMV infection is clinically progressing or CMV viremia is persistent or increasing (as evidenced by quantitation of CMV antigenemia or CMV DNA in the blood) despite two weeks induction therapy with antiviral drugs. \n\n The patient has developed CMV viremia as attested by viral culture, or detection of CMV antigenemia or detection of levels of CMV DNA in blood or body fluids while receiving prophylactic doses of antiviral drugs to prevent CMV infection post transplant. or \n\n the patient is unable to sustain treatment with antiviral drugs due to drug associated toxicities (e.g. myelosuppression [ANC < 1000 ul/ml without GCSF support] or nephrotoxicity [corrected creatinine clearance < than or equal to 60ml/min/1.73m2 or creatinine >2 mg/dl]). \n\n Because CMV infections are life-threatening and may involve the lungs, liver, gastrointestinal tract, hematopoietic and central nervous systems, and antiviral drugs may also compromise renal and hematopoietic function, dysfunctions of these organs will not affect eligibility for this protocol. \n\n However, to be eligible, the patients should meet the following clinical criteria: \n\n They must have a stable blood pressure and circulation, not requiring pressor support. \n\n They should have adequate cardiac function as demonstrated by EKG and/or by echocardiographic evidence. \n\n They should have a life expectancy, even if they require respirator support, of at least 3 weeks. \n\n They are no age restrictions to eligibility for this protocol. \n\n ", - "exclusion_criteria": ": \n\n Patients requiring high doses of glucocorticosteroids (>0.5 mg/kg prednisone or its equivalent) as treatment for active (grade 2-4) acute graft vs. host disease (GVHD) or chronic GVHD. \n\n Patients who are moribund. \n\n Patients with other conditions not related to CMV infection (e.g. uncontrolled bacterial sepsis or invasive fungal infection) which are also life-threatening and which would preclude evaluation of the effects of a T cell infusion. \n\n Donor Eligibility for Donation of Blood Lymphocytes for Generation of \n\n Donor-Derived CMV-Specific T cells: \n\n Adequate health for donation as determined by institutional (related donor) or NMDP (unrelated donor) guidelines. Normal donors will be evaluated for evidence of prior sensitization to CMV by CMV serology. They will also be typed for HLA A, B, C and DR. For allogeneic hematopoietic progenitor cell transplant (HSCT) recipients, the marrow transplant donor will constitute the donor of choice, since those T-cells will grow and persist in a patient who has already engrafted with a transplant from that donor. However, if the HSCT donor is CMV seronegative or not available (e.g. a cord blood transplant or an unrelated donor who has not already donated T-cells for adoptive therapy), CMV-specific T-cells generated from a seropositive donor matched for at least 2 HLA alleles shared by the patient may be used. \n\n Normal donors fulfilling these criteria who consent to donate blood for the generation of CMV-specific T-cells for adoptive therapeutic purposes will receive a detailed clinical evaluation, including a medical history, physical examination, and serologic testing for transmissible diseases within 1 week of donation including hepBs Ag and hepatitis C antibody, HIV-1 and 2, HTLV-1 and 2, CMV (only if previously negative), VDRL, WNV, and Chagas An HIV+ donor will be rejected on medical grounds. Donors must have Hgb value > 10 gm/dl and must be capable of undergoing a single 3-6 unit leukapheresis (preferable) or a single unit of blood for T cells (for pediatric donors, no more than 5 ml/kg at any one blood draw). \n\n A prospective donor will be informed of the purposes of this study, and its requirements. If he/she consents, the donor will be requested to provide two blood samples: \n\n i. An initial donation of 25ml blood anticoagulated with heparin or ACD. This blood is used to establish a B cell line transformed with the B95.8 laboratory strain of EBV. This EBV+ B cell line/ (EBVBLCL) will be used as an antigen-presenting cell. When loaded with the pool of CMVpp65 pentadecapeptides, the EBVBLCL efficiently sensitize T cells from the same donors against CMV as well as EBV. \n\n Because the establishment and testing of an EBV transformed B cell line suitable for use or as an antigen-presenting cell require 4-5 weeks of in vitro culture, it is important that this sample be obtained as early as possible for patients at risk for a CMV infection. Because patients receiving HSCT from unrelated or HLA disparate donors are particularly at risk for severe CMV infections in the first 2-3 months after transplant, this blood sample should be obtained from the donor prior to donation of the hematopoietic progenitor cell transplant whenever possible. \n\n ii. A donation of either a single standard 2 blood volume leukapheresis collected in standard ACD anticoagulant. If it is impossible to collect a leukapheresis from some of the donors, a unit of whole blood will be acceptable. However, the AICTF (Adoptive Immune Cell Therapy Facility manufacturing the clinical grade cell products under GMP conditions in MSKCC) may only be able to generate a limited number of T cells from a unit of blood. This blood is required for isolation of the T cells to be sensitized with the pool of CMVpp65 15-mers loaded on the autologous EBVBLCL, and propagated in vitro. In addition, it is required to provide autologous feeder cells essential to sustain T-cell growth without the risk of stimulating the growth of alloreactive T-cells capable of inducing GVHD. \n\n This donation of a leukapheresis or a unit of blood will be obtained from unrelated HSCT donors at least 2 weeks after their donation of an HSCT, or as soon as possible thereafter. \n\n In order to limit the number of blood or leukapheresis donations that would be required of any donor, each donor will be informed of the following potential applications of the blood cells donated. The white cells contained in one leukapheresis are sufficient to grow enough T- cells to treat the three conditions below in a transplant patient: \n\n The use of cells to generate CMV-specific T-cells for potential use in the treatment of the patient for whom the donor has provided an HSCT, under MSKCC IRB # 05-065. \n\n The use of a fraction of the cells isolated to generate: \n\n immune T-cells specific for another virus, such as Epstein-Barr virus, that can cause lethal lymphomas in transplant recipients, and \n\n immune T-cells specific for a protein called WT-1, that is differentially expressed by malignant blood cells. \n\n Such T-cells could be used, under separate protocols, to treat EBV associated diseases (IRB 95-024) and/or to treat or prevent leukemia recurrence (07-055) in the patient receiving the donor's hematopoietic progenitor cell transplant. \n\n The donation of the immune T-cells generated from the donor that are not used for or required by the patient for whom they were originally intended to a bank of immune cells that will be stored and maintained cryopreserved under GMP conditions in the Adoptive Immune Cell Therapy Facility at MSKCC, These stored T-cells , may be used for the treatment of other patients with CMV or EBV infections/malignancies that express HLA alleles shared by the donor. \n\n In addition to these prospectively accrued donors, we have, since the initiation of this protocol, generated over 100 CMV-specific T-cells for patients at high risk for infection, of which far fewer patients have required treatment. Since these patients are now beyond the period of risk for CMV infection, their donors will be approached with a separate consent to allow for the use of their T cells in recipients other than the primary patients for whom they initially donated cells.", - "brief_summary": "The purpose of this study is to test the safety of a transfusion of specialized white cells from your transplant donor's blood, called T-cells, that have been grown and immunized against the CMV virus in the test tube. If the transplant donor is immune to CMV (ie: the donor has antibody to CMV in the blood), the T-cells will be selected and grown from the blood of the transplant donor. However, if the transplant donor is not immune to CMV, or if T-cells from the donor are not readily available, CMV-immune T-cells grown from the blood of another normal donor who is partially matched to the patients tissue type can be used. The transplant physician will explain which of these treatments is available to the patient.~This trial is called a phase I trial because phase I trials are designed to test the safety of different doses of an experimental treatment. We want to find out what effects, good and/or bad, a dose/doses of these immune T-cells will have on the patient and on the CMV infection.~Specifically, we wish to test CMV immune T-cells grown from your blood using a new method developed at our center. In this method, fragments of an important CMV protein, called CMVpp65, are chemically synthesized and then used to immunize T-cells in the test tube.", - "NCTID": "NCT00674648" - }, - { - "brief_title": "Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome", - "phase": "Phase 1", - "drugs": "['Foscarnet sodium']", - "drugs_list": [ - "Foscarnet sodium" - ], - "diseases": "['Cytomegalovirus Retinitis', 'HIV Infections']", - "diseases_list": [ - "Cytomegalovirus Retinitis", - "HIV Infections" - ], - "enrollment": "53.0", - "inclusion_criteria": "", - "exclusion_criteria": " \n\n Concurrent Medication: \n\n Excluded: \n\n Acyclovir. \n\n Zidovudine (AZT). \n\n Any potentially nephrotoxic agent, especially aminoglycosides, pentamidine, or amphotericin B. \n\n Prior Medication: \n\n Excluded: \n\n Ganciclovir. \n\n Foscarnet. \n\n Excluded within 7 days of study entry: \n\n Any potentially nephrotoxic agent. \n\n Excluded within 14 days of study entry: \n\n Cytomegalovirus hyperimmune globulin in therapeutic doses. \n\n Immunomodulators. \n\n Biologic response modifiers. \n\n Investigational agents. \n\n Amphotericin B maintenance for a systemic mycosis. \n\n Known allergy to foscarnet. \n\n Active AIDS-defining opportunistic infection other than cytomegalovirus (CMV) including systemic mycosis, pulmonary or neurologic impairment (comatose). \n\n Patient must be diagnosed as having: \n\n AIDS CDC Group IV.C. \n\n Cytomegalovirus (CMV) retinitis as identified by its characteristic ophthalmoscopic appearance and verified by fundus photography. \n\n One pending culture for CMV from blood and urine prior to study entry.", - "brief_summary": "To explore the safety and usefulness of foscarnet, an antiviral agent, in the treatment of cytomegalovirus (CMV) retinitis. Untreated CMV retinitis is a rapidly progressive, blinding disease in AIDS patients. The manner in which foscarnet breaks down in the body and the effect of increasing periodic intravenous doses are also studied. Foscarnet is active in vitro (test tube) against herpes viruses, including CMV, by inhibiting the virus DNA polymerases, enzymes necessary for virus replication, without affecting cellular DNA polymerases. Opportunistic CMV disease in AIDS is usually seen as retinitis, colitis, esophagitis, hepatitis, pancreatitis, encephalitis, or pneumonia. Ganciclovir has been used to treat AIDS patients with CMV disease but can cause severe neutropenia (very low neutrophil cell counts). Foscarnet does not suppress the production of neutrophils or other leukocytes (myelosuppression) and has shown in vitro activity against HIV.", - "NCTID": "NCT00000726" - }, - { - "brief_title": "Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component", - "phase": "", - "drugs": "['Foscarnet sodium', 'Ganciclovir']", - "drugs_list": [ - "Foscarnet sodium", - "Ganciclovir" - ], - "diseases": "['Cytomegalovirus Retinitis', 'HIV Infections']", - "diseases_list": [ - "Cytomegalovirus Retinitis", - "HIV Infections" - ], - "enrollment": "240.0", - "inclusion_criteria": "inclusion criteria \n\n Concurrent Medication: \n\n Allowed: \n\n Topical anti-Herpesvirus agents. \n\n Zidovudine (AZT) for patients in deferral or foscarnet treatment groups: \n\n 100 mg every 4 hours. For patients on ganciclovir: \n\n 100 mg every 8 hours. \n\n Dideoxyinosine (ddI) and other antiretroviral available via expanded access programs, investigational triazoles, granulocyte-macrophage colony-stimulating factor, and erythropoietin to treat marrow toxicity. The use of other investigational drugs will be considered on a drug by drug basis. \n\n It is not recommended that patients receiving ganciclovir take AZT simultaneously. If AZT is prescribed for patients taking ganciclovir, it should be prescribed at reduced doses and discontinued if hematologic toxicity develops. \n\n Patients must have: \n\n Diagnosis of AIDS by CDC criteria or a documented HIV infection. \n\n Cytomegalovirus (CMV) retinitis that does not require surgical intervention diagnosed in one or both eyes by a SOCA-certified ophthalmologist. \n\n The means available for compliance with follow-up visits (including a caregiver if necessary). \n\n Must consent to study or consent of parent or guardian if less than 18 years of age. \n\n Willingness to take reduced dose of zidovudine (AZT) if dictated by treatment assignment. \n\n Willingness to discontinue other systemic treatments for Herpesvirus infections while receiving foscarnet or ganciclovir. \n\n Prior Medication: \n\n Allowed: \n\n Zidovudine (AZT). \n\n ", - "exclusion_criteria": " \n\n Co-existing Condition: \n\n Patients with the following conditions or symptoms are excluded: \n\n Sufficient media opacities to preclude fundus photographs in both eyes. \n\n Concurrent Medication: \n\n Excluded: \n\n Other systemic treatments for Herpesvirus infections. \n\n Other anti-cytomegalovirus therapy. \n\n Excluded with foscarnet: \n\n Parenteral pentamidine, amphotericin B, or aminoglycosides. \n\n Use of marrow toxic agents with ganciclovir and nephrotoxic agents with foscarnet is discouraged, and alternative treatment should be used whenever possible. \n\n Patients with the following are excluded: \n\n Sufficient media opacities to preclude fundus photographs in both eyes. \n\n Known or suspected allergy to one of the study medications. \n\n Prior Medication: \n\n Excluded: \n\n Foscarnet or ganciclovir used previously to treat cytomegalovirus (CMV) retinitis. \n\n Excluded within 14 days of study entry: \n\n CMV hyperimmunoglobulin or other anti-CMV agents. \n\n Excluded within the past 28 days: \n\n Anti-CMV therapy. \n\n Active intravenous drug or alcohol abuse, sufficient in the investigator's opinion to prevent adequate compliance with study therapy and follow-up.", - "brief_summary": "To evaluate the relative effectiveness and safety of foscarnet versus ganciclovir for the treatment of cytomegalovirus (CMV) retinitis in people with AIDS; to evaluate the relative effect on survival of the use of these two anti-CMV agents in the treatment of CMV retinitis; to compare the relative benefits of immediate treatment with foscarnet or ganciclovir versus deferral of treatment for CMV retinitis limited to less than 25 percent of zones 2 and 3.~CMV retinitis is a common opportunistic infection in patients with AIDS. Ganciclovir is currently the only drug approved for treatment of CMV retinitis in immunocompromised patients. Ganciclovir suppresses CMV infections, and relapse occurs in virtually all AIDS patients when ganciclovir is discontinued. Because of their similar hematologic (blood) toxicities, the simultaneous use of ganciclovir and zidovudine (AZT) is not recommended. More recently the drug foscarnet has become available for investigational use. Studies so far indicate that remission of CMV retinitis occurs in 36 to 77 percent of patients, and that relapse occurs in virtually all patients when the drug is discontinued. The relative effectiveness of foscarnet compared with ganciclovir for the immediate control of CMV infections is unknown. Further, the long-term effects of foscarnet or ganciclovir on CMV retinitis, survival, and morbidity are unknown. There is also no definitive information on the relative effectiveness and safety of deferred versus immediate treatment for CMV retinitis confined to zones 2 and 3.", - "NCTID": "NCT00000665" - }, - { - "brief_title": "A Study of Foscarnet Plus Ganciclovir in the Treatment of Cytomegalovirus of the Eye in Patients With AIDS Who Have Already Been Treated With Ganciclovir", - "phase": "Phase 1", - "drugs": "['Foscarnet sodium', 'Ganciclovir']", - "drugs_list": [ - "Foscarnet sodium", - "Ganciclovir" - ], - "diseases": "['Cytomegalovirus Retinitis', 'HIV Infections']", - "diseases_list": [ - "Cytomegalovirus Retinitis", - "HIV Infections" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria \n\n Concurrent Medication: \n\n Allowed: \n\n Chemotherapy for Kaposi's sarcoma (excluding interferon) if patient is hematologically stable for at least 30 days prior to entry. \n\n Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC) after first two weeks of study period if absolute neutrophil count is > 1000 cells/mm3 and hemoglobin = or > 8 g/dl. \n\n Vancomycin. \n\n Fluconazole or investigational triazoles (e.g., itraconazole, SCH 39304) for disseminated fungal infection. \n\n Pneumocystis carinii pneumonia prophylaxis (except parenteral pentamidine). \n\n Acyclovir or other appropriate medication may be instituted in the event of the appearance of Herpes simplex virus \n\n (HSV) or Varicella zoster virus (VZV) infections. \n\n G-CSF or GM-CSF for grade 4 neutropenia. \n\n Concurrent Treatment: \n\n Allowed: \n\n Recombinant human erythropoietin. \n\n Prior Medication: Required: \n\n Completion of 14-day course of intravenous ganciclovir induction therapy (2.5 mg/kg IV q8h or 5 mg/kg q12h for 14 days) or foscarnet induction therapy (60 mg/kg q8h adjusted for renal function for 14 days) within 1 week prior to study entry. Patients who do not initiate the study immediately upon completing ganciclovir induction therapy should receive a maintenance ganciclovir regimen of 5 mg/kg/day or 6 mg/kg/day 5 x week or a foscarnet regimen of 90-120 mg/kg/day until initiating study drug. \n\n Patients must: \n\n Have a diagnosis of cytomegalovirus retinitis and HIV infection. \n\n Be capable of giving informed consent. Patients < 18 years of age may participate with the consent of parent, guardian, or person with power of attorney. \n\n Allowed: \n\n History of seizure disorder or a central nervous system (CNS) mass lesion. \n\n ", - "exclusion_criteria": " \n\n Co-existing Condition: \n\n Patients with the following conditions or symptoms are excluded: \n\n Evidence of tuberculous, diabetic or hypertensive retinopathy. \n\n Osteomalacia, neoplasm metastatic to bone or other bone disease. \n\n Any clinically significant pulmonary or neurologic impairment (for example, patients who are intubated or comatose). \n\n Retinal detachment. \n\n Corneal, lens, or vitreous opacification precluding funduscopic exam. \n\n Concurrent Medication: \n\n Excluded: \n\n Immunomodulators, biologic response modifiers or investigational agents not specifically allowed. \n\n Aminoglycosides, amphotericin B, probenecid, parenteral pentamidine. \n\n Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC) until completion of second week of maintenance therapy. ddC use is discouraged but not prohibited because of paucity of experience of this drug with ganciclovir and foscarnet. \n\n Anti-cytomegalovirus (CMV) therapy: \n\n Ganciclovir, CMV hyperimmune serum/globulin, interferons, immunomodulators. \n\n Prophylactic antiviral therapy with acyclovir. \n\n Patients with the following are excluded: \n\n Active AIDS-defining opportunistic infection requiring therapy that is currently causing nephrotoxicity or myelosuppression. \n\n Known hypersensitivity to either of the study therapies. \n\n Prior Medication: \n\n Excluded: \n\n Foscarnet or ganciclovir for CMV retinitis (excluding the 14-day induction period). \n\n Prior Treatment: \n\n Excluded: \n\n Cytomegalovirus (CMV) hyperimmune globulin within 14 days prior to study entry.", - "brief_summary": "To examine the safety and tolerance of the administration of ganciclovir and foscarnet given together or alternately; to determine the interactive pharmacokinetics (blood level) profile of long-term combined and alternating therapy with these two drugs. Additional objectives are to examine the effect of these treatments in controlling time to cytomegalovirus (CMV) retinitis progression and to examine the antiviral activity of combined and alternating ganciclovir/foscarnet treatment and development of antiviral resistance. Sight-threatening CMV retinitis occurs in at least 6 percent of AIDS patients. By 1991 (US), there may be 6000 to 10000 patients with CMV retinitis. Many clinical reports suggest that both ganciclovir (DHPG) and foscarnet have an antiviral effect against CMV that is often associated with clinical stabilization. Effectiveness of ganciclovir and foscarnet is correlated with weekly maintenance and since toxicity is dose-limiting in up to 20 percent of patients receiving either drug for long periods, it may be beneficial in long-term maintenance treatment to combine or alternate these two drugs at a lower total weekly dose of each drug.~This strategy may result in a greater net antiviral effect with less toxicity than is seen with either drug alone, because the toxicities of each drug are quite different.", - "NCTID": "NCT00000970" - }, - { - "brief_title": "Trial of Preemptive Treatment With Oral Valganciclovir Compared With Intravenous (IV) Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cell Transplant", - "phase": "Phase 3", - "drugs": "['Valganciclovir', 'Ganciclovir']", - "drugs_list": [ - "Valganciclovir", - "Ganciclovir" - ], - "diseases": "['Cytomegalovirus Infections']", - "diseases_list": [ - "Cytomegalovirus Infections" - ], - "enrollment": "39.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients receiving allogeneic peripheral blood stem cell transplant from either a related or unrelated donor at Washington University Medical Center. \n\n An initial episode of CMV viremia. \n\n At the time of randomization: \n\n ANC greater than or equal to 1000 \n\n Age greater than or equal to 18 \n\n Adequate renal function with creatinine clearance greater than 10 ml/min \n\n Total bilirubin less than or equal to 3.0 \n\n ", - "exclusion_criteria": ": \n\n Current GI graft versus host disease grade III-IV \n\n Development of CMV disease prior to or at the time of the first detection of CMV viremia by PCR \n\n Uncontrolled emesis or diarrhea (greater than or equal to 4 episodes per day) for 2 consecutive days \n\n Pregnant or nursing female patient \n\n Known hypersensitivity to ganciclovir", - "brief_summary": "The purpose of this trial is to determine if preemptive therapy with oral valganciclovir is as effective as intravenous ganciclovir in clearing cytomegalovirus (CMV) viremia as determined by quantitative CMV polymerase chain reaction (PCR) assay in patients who have undergone bone marrow or peripheral blood stem cell transplant.", - "NCTID": "NCT00241345" - }, - { - "brief_title": "Natural History of Cytomegalovirus (CMV) Infection and Disease Among Renal Transplant Recipients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Infection in Solid Organ Transplant Recipients']", - "diseases_list": [ - "Infection in Solid Organ Transplant Recipients" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Informed consent. \n\n Male/female patients at least 18 years old who will be followed at our outpatient clinic for at least one year. \n\n Recipients of first or repeat kidney transplants from living or deceased donors. \n\n ", - "exclusion_criteria": ": \n\n Recipients of any combined transplant (kidney/pancreas, kidney liver). \n\n Unlikely to comply with the requirements of the study.", - "brief_summary": "Although the accumulated knowledge regarding Cytomegalovirus (CMV) infection increased substantially over the past years, several issues still deserve further investigation. The epidemiology of this disease has been changing, perhaps influenced by new immunosuppressive strategies currently used and growing and widespread use of prophylaxis. The knowledge of the CMV viral load kinetics, using a polymerase chain reaction (PCR-based assay), among renal transplant recipients not receiving any prophylactic therapy will allow the determination of risk factors for and the impact of earlier intervention on CMV infection and disease. The goal is to ultimately improve the clinical outcomes for renal transplant recipients.", - "NCTID": "NCT01833416" - }, - { - "brief_title": "Probiotics for Prevention of Ventilator-Associated Pneumonia (VAP)", - "phase": "Phase 4", - "drugs": "['Probiotics', 'control']", - "drugs_list": [ - "Probiotics", - "control" - ], - "diseases": "['Drug Safety']", - "diseases_list": [ - "Drug Safety" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient age \u2265 18-year who received ventilator and agreed to participate by signing informed consent form \n\n ", - "exclusion_criteria": ": \n\n Immunocompromised host (e.g. HIV infection, On immunosupressive agents, ANC \u2264 500 cell/ml), Pregnancy, History of congenital heart disease, rheumatic fever, previously infective endocarditis, prosthetic valve, Contraindication for enteral feeding, History of milk or milk-product allergy", - "brief_summary": "Hospitalized patients with ventilator are randomized to receive fermented dairy product containing L. casei shirota or nothing. The main outcome is development of ventilator-associated pneumonia (VAP)", - "NCTID": "NCT01301131" - }, - { - "brief_title": "Galactomannan Antigen in Bronchoalveolar Lavage in the Diagnosis of Invasive Aspergillosis in Neutropenic Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Invasive Aspergillosis']", - "diseases_list": [ - "Invasive Aspergillosis" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n 100 BAL in hematological neutropenic patients at high risk of IA, admitted to our hospital, in which we usually perform a BAL for microbiological study when they present persistent fever and an opportunist infection suspicion. \n\n 100 BAL in patients without hematological illness and without IA suspicion, in which we perform an BAL because of another reason. \n\n ", - "exclusion_criteria": ": \n\n Patients without fulfilling inclusion criteria. \n\n Patients with some contraindication to perform a bronchoscopy.", - "brief_summary": "Invasive Aspergillosis (IA) is a very serious fungal infection. Hematological patients are the most affected group. IA has a very high morbimortality due to its rapid progression and because it is very difficult to be early diagnosed. Diagnosis is used to be done too late or even post-mortem. They are two new methods (techniques) trying to make the diagnosis on an early stage: detection of Galactomannan antigen of Aspergillus species and real - time polymerase chain reaction (PCR) of its DNA in blood. IA in immunocompromised patients is mainly located in lungs, so our hypothesis is that in patients where the investigators suspect IA the investigators should find earlier Galactomannan antigen or real -time PCR of Aspergillus in respiratory samples such as bronchoalveolar lavage (BAL), and its detection could be useful for diagnosis.~Objectives: To detect Galactomannan Antigen and Real Time - PCR for Aspergillus DNA in bronchoalveolar lavage. To validate the routine utility of these tests in BAL as a diagnostic method of IA and investigate if Galactomannan Antigen and Real Time - PCR for Aspergillus DNA in bronchoalveolar lavage can optimize blood test sensibility.~Methods: Prospective study. The investigators will include 200 patients. 100 of them will be hematological patients, neutropenic and at high risk to develop an IA. The other 100 will be patients without risk or no suspicion at all of IA. The investigators will perform a BAL in all patients. And blood detection of Galactomannan Antigen in hematological patients. The investigators will perform a standard microbiological culture of BAL and Galactomannan Antigen in both samples (bronchoalveolar lavage and blood). The investigators also will carry out Real Time - PCR for Aspergillus DNA detection in bronchoalveolar lavage.~Expected results: To detect Galactomannan Antigen and Real Time - PCR for Aspergillus DNA in BAL with more specificity and making earlier diagnosis than in blood. The investigators also expect to implant these techniques in BAL in the routine for IA diagnosis in neutropenic patients.", - "NCTID": "NCT01128907" - }, - { - "brief_title": "A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of Inhaled GSK1995057", - "phase": "Phase 1", - "drugs": "['GSK1995057', 'bronchoalveolar lavage', 'LPS', 'Placebo']", - "drugs_list": [ - "GSK1995057", - "bronchoalveolar lavage", - "LPS", - "Placebo" - ], - "diseases": "['Respiratory Disorders']", - "diseases_list": [ - "Respiratory Disorders" - ], - "enrollment": "53.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests nd cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. The investigator may discuss with GSK medical monitor as required. \n\n Male or female between 18 and 55 years of age inclusive: A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 MlU/ml and oestradiol less than 40 pg/ml (less than 140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until the last follow-up visit. \n\n Normal creatinine clearance values at screening (calculated from serum creatinine by a predicting equation using Cockcroft-Gault formula), normal serum creatinine value as defined by the local reference laboratory, normal urine microscopy and no significant proteinuria on dipstick testing. \n\n Body weight greater than and equal to 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive). \n\n No evidence of previous or active TB infection and a negative QuantiFERON TB Gold test taken within 7 days of dosing, and negative medical history with respect to active or latent mycobacterium tuberculosis complex infection. \n\n Normal spirometry (FEV1 greater than and equal to 85% of predicted, FEV1/FVC ratio greater than and equal to 70%) at screening. Predictions should be according to ECCS equations, and race corrections should be made for non-caucasians. \n\n Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. \n\n Available to complete all study assessments. \n\n Subjects who are able to use the inhaler device correctly. \n\n Able to read, comprehend and write English at a sufficient level to complete study related materials. \n\n ", - "exclusion_criteria": ": \n\n A history of Hepatitis B, Hepatitis C or HIV infection and/or a positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening \n\n Current or chronic history of liver disease, or known hepatic or biliary abnormalities. (With the exception of known Gilbert's syndrome or asymptomatic gallstones). \n\n A positive pre-study drug/alcohol screen. \n\n History of and/or a positive test for toxoplasmosis consistent with active toxoplasmosis infection at the time of enrollment. \n\n A positive RT-PCR test for influenza A/B. \n\n Current evidence or history of an influenza-like illness as defined by fever (greater than 380C) and two or more of the following symptoms within the last 7 days: cough, sore throat, runny nose, sneezing, limb/joint pain, headache, vomiting/diarrhoea in the absence of a known cause, other than influenza. \n\n Corrected QT interval (QTc) >450msec. \n\n History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units for males or greater than 14 units for females. One unit is equivalent to 8 g of alcohol and the following can be used as a guide: a half-pint (approximately 240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits. \n\n The subject is unwilling to abstain from alcohol consumption from 24 hr prior to dosing until discharge from the clinic, and for 24 hr prior to all other out-patient clinic visits. \n\n Subjects with a smoking history of greater than 5 cigarettes per day in the last 3 months (Part 1); smokers are not eligible to take part in Part 2.", - "brief_summary": "GSK1995057 is a fully human, single domain antibody directed against the TNFR1 receptor. The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of inhaled GSK1995057 in healthy subjects. The study will be in two parts. Part 1 is a single-dose escalating design of 5 sequential cohorts of healthy subjects. Part 2 is a single-dose, parallel group design comprising 2 groups of healthy subjects assessing the effect of GSK1995057 on lung inflammation following inhaled LPS challenge. Actual dose administered in Part 2 will be determined from emerging safety and PK data from Part 1 and Study TFR110951.", - "NCTID": "NCT01587807" - }, - { - "brief_title": "Infection and Cardiovascular Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cardiovascular Diseases', 'Coronary Disease', 'Cerebrovascular Accident', 'Heart Diseases', 'Myocardial Infarction', 'Infection', 'Chlamydia Infections', 'Cytomegalovirus Infections', 'Helicobacter Infections', 'Atherosclerosis']", - "diseases_list": [ - "Cardiovascular Diseases", - "Coronary Disease", - "Cerebrovascular Accident", - "Heart Diseases", - "Myocardial Infarction", - "Infection", - "Chlamydia Infections", - "Cytomegalovirus Infections", - "Helicobacter Infections", - "Atherosclerosis" - ], - "enrollment": "", - "inclusion_criteria": "No eligibility criteria", - "exclusion_criteria": "", - "brief_summary": "To investigate the role of chronic infection as a risk factor for vascular disease in a study of Native Americans. The primary focus is on the two most common agents Chlamydia pneumoniae and cytomegalovirus with a secondary emphasis on Helicobacter pylori.", - "NCTID": "NCT00005547" - }, - { - "brief_title": "Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus", - "phase": "", - "drugs": "['Blood sample', 'Cord blood sample', 'Saliva swab', 'Urine sampling', 'Vaginal swab']", - "drugs_list": [ - "Blood sample", - "Cord blood sample", - "Saliva swab", - "Urine sampling", - "Vaginal swab" - ], - "diseases": "['Infections, Cytomegalovirus', 'Cytomegalovirus Infections']", - "diseases_list": [ - "Infections", - "Cytomegalovirus", - "Cytomegalovirus Infections" - ], - "enrollment": "160.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects who the investigator believes that they can and will comply with the requirements of the protocol . \n\n A pregnant female, 18 years of age or older at the time of study enrolment. \n\n Women with confirmed primary CMV infection. \n\n Written informed consent obtained from the subject. \n\n ", - "exclusion_criteria": ": \n\n Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study entry. \n\n Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational pharmaceutical product. \n\n Previous vaccination against CMV infection. \n\n Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history or physical examination \n\n Major congenital defects, serious chronic illness or organ transplantation. \n\n Administration of immunoglobulins and/or any blood products within the three months preceding study enrolment or during the pregnancy. \n\n Documented Human immunodeficiency virus (HIV)-positive subject. \n\n Gestational age of more than 34 weeks, as determined by foetal ultrasound.", - "brief_summary": "This study is designed to evaluate maternal virological and immunological parameters to determine their ability to predict congenital cytomegalovirus (CMV) infection. When a pregnant woman is infected with CMV, her immune system (which protects her from infection) is activated and the virus can be found in the woman's bodily fluids (blood, saliva, urine, vaginal secretions). The aim of this study is to find out if there is a link between either the pregnant woman's immune response or the presence of the virus in these bodily fluids and the child/foetus being infected with the virus.", - "NCTID": "NCT01251744" - }, - { - "brief_title": "Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients With Acute Exacerbation of Bronchiectasis", - "phase": "Phase 4", - "drugs": "['Bronchoalveolar Lavage and Local Amikacin Injection']", - "drugs_list": [ - "Bronchoalveolar Lavage and Local Amikacin Injection" - ], - "diseases": "['Bronchiectasis']", - "diseases_list": [ - "Bronchiectasis" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Age\u226518 years and \u226480 years; \n\n Patients with non-cystic fibrosis bronchiectasis diagnosed by high-resolution CT; \n\n Are sensitive to amikacin; \n\n Acute exacerbation of bronchiectasis; \n\n Capable of the completion of bronchoscopy, alveolar lavage, pulmonary function testing etc; \n\n Willing to join in and sign the informed consent form. \n\n ", - "exclusion_criteria": ": \n\n Active bleeding without control\uff1b \n\n Receiving nasal or facial surgery recently\uff1b \n\n With severe cardio-pulmonary dysfunction, such as left heart failure, unstable arrhythmia, etc. \n\n With other respiratory diseases: such as active pulmonary tuberculosis, non-tuberculosis mycobacteria (NTM) pulmonary disease, pulmonary aspergillosis, etc. \n\n Be allergic to amikacin", - "brief_summary": "The therapy of bronchoalveolar lavage and local amikacin injection as one of the treatment of bronchiectasis developed in recent years.this study is aim to evaluate the Clinical Efficacy and Safety of Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients with Acute Exacerbation of Bronchiectasis.", - "NCTID": "NCT02509091" - }, - { - "brief_title": "Diagnosis of Ventilator- Associated Pneumonia in Children: A Comparative Study of Bronchoscopic and Non-Bronchoscopic Methods", - "phase": "Phase 3", - "drugs": "['bronchoaleolar lavage', 'Bronchoscopy']", - "drugs_list": [ - "bronchoaleolar lavage", - "Bronchoscopy" - ], - "diseases": "['Ventilator Associated Pneumonia']", - "diseases_list": [ - "Ventilator Associated Pneumonia" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Children on mechanical ventilation for more than 72 hours and having simplified clinical pulmonary infection score more than 6 were included in study. \n\n ", - "exclusion_criteria": ": \n\n Age less than 1 month.", - "brief_summary": "Background and Objectives: There is a need to validate and suggest easy and less costly diagnostic method for diagnosis of ventilator-associated pneumonia in developing country. The study was performed to compare available methods for the diagnosis and to characterize the organisms causing VAP.~Design and Methods: All patients on mechanical ventilation for more than 48 hours and simplified CPIS \u2265 6 were enrolled prospectively. Four diagnostic procedures, endotracheal aspiration (ETA), blind bronchial sampling (BBS), blind bronchoalveolar lavage (blind BAL) and bronchoscopic BAL (BAL) were performed in same sequence within 12 hours. The bacterial density \u2265 104 cfu/ mL BAL samples were taken as reference standard.", - "NCTID": "NCT00495963" - }, - { - "brief_title": "Alternate Donor Study of Pre-Emptive Cellular Therapy", - "phase": "Phase 2", - "drugs": "['CMV-specific T-cells, single infusion following single positive CMV PCR result']", - "drugs_list": [ - "CMV-specific T-cells", - "single infusion following single positive CMV PCR result" - ], - "diseases": "['Cytomegalovirus Infection']", - "diseases_list": [ - "Cytomegalovirus Infection" - ], - "enrollment": "52.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 16 years or older \n\n cytomegalovirus seropositive allogeneic T cell depleted (alemtuzumab-containing conditioning regimen) hematopoietic stem cell transplant recipient with cytomegalovirus (CMV) seropositive unrelated donor \n\n Patient Informed consent \n\n Prepared to undergo additional study procedures as per study schedule \n\n Patient has undergone counselling about risk \n\n Donor engraftment (neutrophils > 0.5x109/l)(to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion) \n\n Single positive cytomegalovirus PCR result (And to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion) \n\n The donor will be selected from the Anthony Nolan Trust registry or other donor registries that have approved the protocol and consent procedure. \n\n Donor must have met requirements of EU Tissue and Cells Directive(2004/23/EC) as amended and the UK statutory instruments pursuant therein. \n\n Healthy, Cytomegalovirus (CMV)seropositive donor - having passed medical for stem cell donation \n\n Subject and Donor must have negative serology for Human immunodeficiency virus (HIV), Hepatitis B and C, syphilis \n\n human leukocyte antigen (HLA) type A*0101, A*0201, A*2402, B*0702 and B*0801 \n\n Donor informed consent for stem cell mobilisation leucapheresis and storage \n\n ", - "exclusion_criteria": ": \n\n Pregnant or lactating women \n\n Co-existing medical problems that would place the patient at significant risk of death due to Graft versus Host Disease (GVHD) or its sequelae \n\n Human immunodeficiency virus infection \n\n Active acute Graft versus Host Disease (GVHD) > Grade I (to be assessed prior to CMV-specific T cell infusion ) \n\n Concurrent use of systemic corticosteroids(to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion ) \n\n Organ dysfunction (to be assessed prior to cytomegalovirus-specific T cell infusion ) as measured by: \n\n creatinine > 200 uM/l \n\n bilirubin > 50 uM/l \n\n alanine transferase > 3x upper limit of normal \n\n Donor pregnant or lactating \n\n Donor platelets < 50x109/l", - "brief_summary": "The purpose of this study is to evaluate the potential clinical benefit of pre-emptive cytomegalovirus (CMV)-specific adoptive cellular therapy following T cell depleted allogeneic hematopoietic stem cell transplantation (HSCT) for reducing recurrent CMV reactivation.", - "NCTID": "NCT01220895" - }, - { - "brief_title": "A Study to Evaluate Safety and Tolerability of a Therapeutic Vaccine, ASP0113, in Subjects Undergoing Allogeneic Hematopoietic Cell Transplant", - "phase": "Phase 2", - "drugs": "['ASP0113']", - "drugs_list": [ - "ASP0113" - ], - "diseases": "['Allogeneic Hematopoietic Cell Transplant']", - "diseases_list": [ - "Allogeneic Hematopoietic Cell Transplant" - ], - "enrollment": "9.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject is planned to undergo either of the following: \n\n Sibling Donor Transplant - 7/8 Human Leukocyte Antigen (HLA)-A, -B, -C, -DR\u00df1 match utilizing high resolution typing or 8/8 (HLA)-A, -B, -C, -DR\u00df1 match utilizing low or high resolution typing. \n\n Unrelated Donor Transplant - 7/8 or 8/8 HLA-A, -B, -C, -DR\u00df1 match utilizing high resolution typing. \n\n Subject has one of the following underlying diseases: Acute myeloid leukemia (AML) /Acute lymphoblastic leukemia (ALL) / Acute undifferentiated leukemia (AUL) /Acute biphenotypic leukemia / Chronic myelogenous leukemia (CML) / Chronic lymphocytic leukemia (CLL) / myelodysplastic syndrome(s) (MDS) \n\n Subject is scheduled to receive an allogeneic peripheral blood stem cell (PBSC) or bone marrow transplant (BMT) for the treatment of hematologic disorders \n\n ", - "exclusion_criteria": ": \n\n Subject has active CMV disease or infection or has received treatment for active CMV disease or infection within 90 days prior to transplant \n\n Subject has planned CMV prophylactic therapy with antiviral drugs or CMV-specific immunoglobulins \n\n Subject has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score > 3 \n\n Subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA) \n\n Subject has received any of the following substances or treatments: \n\n T-cell depletion of donor cell product. \n\n Alemtuzumab within 60 days prior to transplant, including conditioning regimen. Subjects for whom treatment with alemtuzumab is planned at any time from 60 days prior to through one year post-transplant should not be enrolled in the trial. \n\n Administration of a CMV vaccine, including any prior exposure to ASP0113. \n\n Subject has received an allogeneic stem cell transplant within one year prior to transplant \n\n Subject has a current malignancy in addition to the malignancy being treated for the study or the subject has a history of any other malignancy \n\n Subject has an unstable medical or psychiatric condition, including a history of illicit drug(s) or alcohol abuse that the Investigator believes will interfere with protocol requirements.", - "brief_summary": "This study is to evaluate safety and tolerability of a therapeutic vaccine, ASP0113, in subjects undergoing allogeneic HCT. The occurrence of CMV viremia and immunogenicity are also assessed.", - "NCTID": "NCT01903928" - }, - { - "brief_title": "The Effects of Conversion From Cyclosporine to Tacrolimus on the Changes of Cardiovascular Risk Profiles and Serum Metabolites in Renal Transplant Recipients", - "phase": "Phase 4", - "drugs": "['Tacrolimus']", - "drugs_list": [ - "Tacrolimus" - ], - "diseases": "['CYCLOSPORINE/TACROLIMUS']", - "diseases_list": [ - "CYCLOSPORINE/TACROLIMUS" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who received a kidney transplant at least 12 months ago prior to enrollment \n\n Patients who have kept in unchanged cyclosporine therapy at least for 6 months prior to enrollment. \n\n Female patients of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment, and agreed to the deliberate prevention of conception during the trial \n\n Patients who are considered clinically stable by observer's judgment. \n\n Patients must understand the purpose and risk of participating the the trial and signed on the written consent. \n\n ", - "exclusion_criteria": ": \n\n Patients who have previously received an organ transplant other than a kidney \n\n Patients diagnosed with congestive heart failure within 6 months (EF <35%) \n\n Patients with untreated ischemic heart disease \n\n Patients whose hemoglobin is in the level of <7.0 g/dL \n\n Patients who have a known hypersensitivity to tacrolimus \n\n Patients taking potassium sparing diuretics \n\n Patients newly diagnosed malignant tumors after organ transplant but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted \n\n Patients who are at the risk of drug abuse or mental disorders or communicate difficulties with the observer \n\n Patients who are pregnant or lactating", - "brief_summary": "The purpose of this study is to evaluate the effects of conversion from cyclosporine to tacrolimus on the changes of cardiovascular risk profiles and serum metabolites in renal transplant recipients.", - "NCTID": "NCT02496494" - }, - { - "brief_title": "Phase III Trial to Evaluate Efficacy and Safety of a Tetravalent Dengue Vaccine", - "phase": "Phase 3", - "drugs": "['Dengue 1,2,3,4 (attenuated) vaccine', 'Placebo']", - "drugs_list": [ - "Dengue 1,2,3,4 (attenuated) vaccine", - "Placebo" - ], - "diseases": "['Dengue']", - "diseases_list": [ - "Dengue" - ], - "enrollment": "16935.0", - "inclusion_criteria": "inclusion criteria: \n\n Children who have completed 24 months of age, adolescents and adults who have not completed 60 years of age; \n\n Agree with periodic contacts, either/or by phone, electronic means, and home visits. \n\n Show voluntary intention to participate in the study, documented by the participant's or participant's legal representative's signature of the informed consent form. \n\n ", - "exclusion_criteria": ": \n\n For women: Pregnancy (confirmed by positive beta-hCG test) or breastfeeding; \n\n Evidence of active neurological, cardiac, pulmonary, hepatic or renal disease as per clinical history and/or physical examination; \n\n Compromised immune system diseases including: decompensated diabetes mellitus, cancer (except basal cell carcinoma), congenital or acquired immune deficiencies and not controlled autoimmune, as per clinical history and/or physical examination; \n\n Behavioral, cognitive or psychiatric disease that in the opinion of the principal investigator or his representative physician, affects the participant ability to understand and cooperate with all study protocol requirements; \n\n Abusive usage of alcohol or drugs in the past 12 months that has caused medical, professional or family problems, indicated by clinical history; \n\n History of severe allergic reactions or anaphylaxis to the vaccine or to components of the vaccine in study; \n\n History of asplenia; \n\n Use of any investigational product within 28 days before or after receiving this study vaccination; \n\n Has participated in another clinical trial six months prior to inclusion in the study or planning to participate in another clinical trial within 2 years following inclusion; \n\n Use of immunosuppressant drugs such as: antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use (except topical or nasal). For this protocol will be considered for exclusion use of corticosteroids 3 months prior to the inclusion in the study and 6 months prior to the inclusion for the other therapies mentioned, and planned use of any immunosuppressant therapy within 2 years following inclusion in the study. It will be considered immunosuppressive dose of corticosteroids the equivalent to a dose \u226520 mg of prednisone per day for adults and the equivalent of prednisone at 2 mg/kg/day for children for over 7 days; \n\n Have received blood products in the past three months, including transfusions or immunoglobulin, or scheduled administration of blood products or immunoglobulin for the following 2 years after vaccination; \n\n Fever or suspected fever within 72 hours prior to vaccination or axillary temperature greater than 37,8\u00b0C on the day of vaccination (inclusion might be postponed until participant has completed 72 hours of no fever); \n\n Have received live virus vaccine within 28 days or killed virus vaccine in the last 14 days prior to vaccination, or have a scheduled immunization during the first 28 days after receiving the investigational product; \n\n Any other condition that might put in risk the safety/rights of a potential participant or hurdle his/her compliance with this protocol in investigator's opinion or his representative physician.", - "brief_summary": "This is a randomized, multicenter, double-blind, placebo-controlled Phase III study that will evaluate efficacy and safety of a live attenuated, tetravalent, lyophilized dengue vaccine produced by Butantan Institute.~The study will be carried out in multiple sites in Brazil. The study will be community-based in select urban areas where there's dengue transmission.~Study's intervention will be a single dose of the tetravalent dengue vaccine or placebo in a ratio 2:1. For efficacy analysis will be considered all dengue cases occurring after 28 days post-vaccination in the entire population of 16944 participants.~For safety analysis participants will be divided in three age groups: 18 to 59 ys, 7-17 ys and 2 to 6 ys. In each of these age groups there will be a minimum of 4992 participants. The age groups of 18 to 59 ys and 7 to 17 ys will start first. Once safety data for the first 21 days after vaccination is analysed for 450 participants in 7-to17-ys age group, the following group, of 2 to 6 ys, will start.~The study's hypothesis is that the vaccine under investigation and produced by Butantan Institute is safe and provides protection against dengue symptomatic disease of 80% or more with a lower bound of the 95% confidence interval of 25%. This way, the expected number of dengue cases virologically confirmed is 24 or more which will provide a response in terms of vaccine efficacy.~All participants will be followed up for five years to verify dengue incidence, regardless severity.", - "NCTID": "NCT02406729" - }, - { - "brief_title": "TT-CMV Observational Birth Cohort Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cytomegalovirus Disease']", - "diseases_list": [ - "Cytomegalovirus Disease" - ], - "enrollment": "600.0", - "inclusion_criteria": "inclusion criteria: \n\n All LBWIs whose weight is \u2264 1500 grams at birth \n\n LBWI is within first five days of life \n\n ", - "exclusion_criteria": ": \n\n LBWI not expected to live past first seven days of life \n\n LBWI has a severe congenital abnormality \n\n LBWI has received a RBC or platelet transfusion at another institution prior to transfer \n\n LBWI has received an in-utero transfusion \n\n LBWI is clinically suspected of having toxoplasmosis, rubella, herpes infection(s) at birth \n\n Refusal by the mother to grant consent for herself and/or refusal to grant consent for her LBWI \n\n If the mother of the child has previously participated in this study", - "brief_summary": "The spread of viruses through transfusions is the cause of serious illness and death in recipients whose immune systems are unable to fight infection. Another group of patients whose immune systems are underdeveloped and can be affected by a particular virus known as cytomegalovirus (CMV) is low birthweight infants (LBWIs). CMV can be spread through the placenta, during the birth process, through breast milk, while in the hospital or while caring for someone carrying the virus as well as through a transfusion, known as transfusion-transmitted (TT-CMV).~The spread of TT-CMV in LBWIs can be curtailed by transfusing blood products that are CMV negative as well as to filter the white cells in blood that carry the virus (leukoreduction). The purpose of this study is to see if the use of these two strategies can lower the spread of CMV through a transfusion. How safe the blood actually is through leukoreduction is not known and CMV still occurs in LBWIs. It is not clear whether this approach is optimal or whether additional safety steps are needed to completely prevent TT-CMV. Specific actions that could tell us when virus has reached the blood product or breast milk is to test each of these to determine if virus slipped unnoticed and/or when the product was not thoroughly filtered.~In this study, the investigators believe that the use of both prevention strategies will result in a lower rate of TT-CMV, and that the cause of TT-CMV may be found in the presence of CMV at the DNA level or by unfiltered white cells that remain in the blood product. Thus, the most significant clinical question that remains to be addressed is whether this double strategy for transfusion safety actually provides a zero CMV-risk blood supply or whether further safety measures (DNA testing + 100% leukoreduction) must be used to protect this extremely vulnerable patient group from CMV infection. This birth cohort study will be done with 6 participating NICUs, and will study both CMV positive and negative mothers in order to estimate the rate and pathway of CMV transmission to the LBWI who receives a transfusion. Another study goal is to compare or link any CMV infection by either transfused units where the virus was undetected, or filter failure. If CMV disease occurs, the investigators will be able to describe the course and outcome in LBWIs who develop TT-CMV.", - "NCTID": "NCT00907686" - } - ], - "1": [ - { - "brief_title": "Immune Response and Cytomegalovirus in Intensive Care Unit (ICU) Patients", - "phase": "", - "drugs": "['Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markings', 'Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markings']", - "drugs_list": [ - "Sampling of blood", - "phenotypic analysis sub-populations NK by cytometric of stream in multiple markings", - "Sampling of blood", - "phenotypic analysis sub-populations NK by cytometric of stream in multiple markings" - ], - "diseases": "['Cytomegalovirus Infection']", - "diseases_list": [ - "Cytomegalovirus Infection" - ], - "enrollment": "29.0", - "inclusion_criteria": "inclusion criteria: \n\n Age more than 18-year-old \n\n Informed consent \n\n ", - "exclusion_criteria": ": \n\n minors, \n\n pregnant or lactating women, \n\n adults under guardianship, \n\n immunosuppression at the entrance to resuscitation, \n\n AIDS", - "brief_summary": "This prospective study evaluate the immune status of patients admitted in ICU.CMV remains dormant in the body, but in people with immune deficiency, CMV could reactivate and cause life-threatening pneumonia.", - "NCTID": "NCT00699868" - }, - { - "brief_title": "Third Party Viral Specific T-cells (VSTs)", - "phase": "Phase 2", - "drugs": "['Viral Specific VST Infusion']", - "drugs_list": [ - "Viral Specific VST Infusion" - ], - "diseases": "['Viral Infection', 'Viral Reactivation', 'Infection in an Immunocompromised Host']", - "diseases_list": [ - "Viral Infection", - "Viral Reactivation", - "Infection in an Immunocompromised Host" - ], - "enrollment": "450.0", - "inclusion_criteria": "inclusion criteria: \n\n Immunocompromised patient with evidence of viral infection or reactivation \n\n Age >1 day \n\n Recipients who have had a stem cell transplant must be at least 21 days after stem cell infusion \n\n Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other steroid equivalent \n\n Must be able to receive CTL infusion in Cincinnati \n\n Informed consent obtained by PI or sub-investigator either in person or by phone \n\n ", - "exclusion_criteria": ": \n\n Active acute GVHD grades II-IV \n\n Uncontrolled bacterial or fungal infection \n\n Uncontrolled relapse of malignancy \n\n Infusion of ATG or alemtuzumab within 2 weeks of VST infusion", - "brief_summary": "The purpose of this study is to demonstrate that viral specific T-cells (a type of white blood cell) can be generated from an unrelated donor and given safely to patients with viral infections.", - "NCTID": "NCT02532452" - }, - { - "brief_title": "Adoptive Immunotherapy for CMV Disease", - "phase": "Phase 1; Phase 2", - "drugs": "['CMV vaccine']", - "drugs_list": [ - "CMV vaccine" - ], - "diseases": "['CMV Disease']", - "diseases_list": [ - "CMV Disease" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n For Patient: \n\n Consenting patients with indication for myeloablative BMT or NST with an HLA matching sibling available, for transplant. \n\n Patients at risk of CMV disease including seronegative patients; patients with seronegative donors, and seronegative donor for sero positive patients. \n\n Patients with resistant CMV viremia or CMV disease not responding to conventional treatment with ganciclovir, or Foscarnet. \n\n Patients with HLA phenotype for which a relevant peptide for CMV exists. \n\n For Donor: \n\n Consenting sibling >18 years old. \n\n HLA phenotype for which a relevant peptide for CMV exists. \n\n ", - "exclusion_criteria": ": \n\n For Patient: \n\n Patients with severe resistant GVHD where there may be a risk to administer DLI or immunized donor lymphocytes. \n\n For Donor: \n\n Consenting sibling >18 years old. \n\n HLA phenotype for which a relevant peptide for CMV exists. \n\n Donor with an infectious disease (e.g. HIV-1; HBV, etc.)", - "brief_summary": "Treatment strategy of patients:~Stem cell engraftment (myeloablative or NST) for induction of host vs graft myeloablative transplantation tolerance.~Whenever indicated, additional post NST DLI given in graded increment, to optimize control of GVHD.~Preparation of immune donor lymphocytes, either by donor immunization in-vitro with a CMV-specific peptide followed by administration of immunized donor lymphocytes, or by injection of donor lymphocytes and in-vivo sensitization of donor lymphocytes in the patient following DLI.~Pre-emptive treatment of seronegative patients at risk or patients with documented viremia or CMV disease with CMV-specific donor lymphocytes generated in-vivo in the donor or in the host by peptide immunization.~Consenting donors will be immunized with CMV-specific peptides, for induction of CTLs in-vivo following subcutaneous inoculation of peptides with adjuvant or donor APC pulsed with relevant peptides.", - "NCTID": "NCT00159055" - }, - { - "brief_title": "Primary Transplant Donor Derived CMVpp65 Specific T-cells for The Treatment of CMV Infection or Persistent CMV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation", - "phase": "Phase 2", - "drugs": "['CMV-pp65 CTLs']", - "drugs_list": [ - "CMV-pp65 CTLs" - ], - "diseases": "['Cytomegalovirus']", - "diseases_list": [ - "Cytomegalovirus" - ], - "enrollment": "58.0", - "inclusion_criteria": "inclusion criteria: \n\n Each patient must satisfy at least one of the following criteria: \n\n The patient must have a clinically documented condition associated with CMV (e.g. interstitial pneumonia, hepatitis, retinitis, colitis) Or \n\n The patient must have microbiological evidence of CMV viremia or tissue invasion as attested by viral culture, or detection of levels of CMV DNA in the blood or body fluids consistent with CMV infection. \n\n Patient must also satisfy at least one of the following criteria: \n\n The patient's CMV infection is clinically progressing or CMV viremia is persistent or increasing (as evidenced by quantitation of CMV DNA in the blood) despite two weeks induction therapy with antiviral drugs. \n\n Or \n\n The patient has developed CMV viremia as attested by viral culture, or detection of levels of CMV DNA in blood or body fluids while receiving prophylactic doses of antiviral drugs to prevent CMV infection post transplant. \n\n Or c. The patient is unable to sustain treatment with antiviral drugs due to drug associated toxicities (e.g. myelosuppression [ANC< 1000\u03bcl/ml without GCSF support] or nephrotoxicity [corrected creatinine clearance \u2264 60 ml/min/1.73 m2 or serum creatinine > 2 mg/dl]) Patient has CMV specific T-cells from the donor of his/her HSCT available. CMV infections are life threatening, and may involve multiple organ systems such as the lungs, liver, gastrointestinal tract, hematopoietic and central nervous systems. Antiviral drugs used for treatment may also compromise renal and hematopoietic function. Therefore, dysfunctions of these organs will not affect eligibility for this protocol Patients must meet the following clinical criteria to receive CMVpp65-CTL infusions \n\n Stable blood pressure and circulation, not requiring pressor support \n\n Evidence of adequate cardiac function as demonstrated by EKG and/or echocardiography. \n\n A life expectancy of at least 3 weeks, even if requiring artificial ventilation. \n\n There are no age restrictions \n\n ", - "exclusion_criteria": ": \n\n Patients requiring high doses of glucocorticosteroids (\u2265 0.3 mg/kg prednisone or its equivalent) 2. Patients who are moribund 3. Patients with other conditions not related to CMV infection (e.g. uncontrolled bacterial sepsis or invasive fungal infection) which are also life-threatening and which would preclude evaluation of the effects of a T-cell infusion. \n\n 3.4. Patients who are pregnant 6.1.3 Donor inclusion criteria 6.1.3a Donors in Group 1 (Historical Donors) Donors in Group 1 (Section 5.1) would have already been determined to be eligible and will have donated blood or leukocytes to establish CMV-specific T-cells under IRB # 05-065, 07-055, 95-024, or 11-130. There are no additional eligibility requirements for these donors. \n\n 6.1.3b Donors in Groups 2 & 3 (Prospective and Volunteer Donors) \n\n Transplant donors and healthy HLA typed volunteers who agree to provide T-cells for Third-party donation (section 5.1, Groups 2 and 3) will need to meet the following eligibility requirements prior to donation: \n\n Donors must satisfy the criteria specified in FDA 21 CFR 1271. \n\n Donors must be typed for HLA-A, B, C and DR \n\n Donors must have a hemoglobin value > 10g/dl \n\n Donors must be capable of undergoing, at least, a single standard 2 blood volume leukapheresis or a donation of one unit of whole blood \n\n 6.1.4 Donor ", - "brief_summary": "The purpose of this study is to see how well transfusions of T-cells work in treating CMV. T-cells are a type of white blood cell that helps protect the body from infection. A transfusion is the process by which blood from one person is transferred to the blood of another. In this case, the T-cells are made from the blood of donors who are immune to CMV. The T-cells are then grown and taught to attack the CMV virus in a lab.", - "NCTID": "NCT01646645" - }, - { - "brief_title": "Trial of Third Party Donor Derived CMVpp65 Specific T-cells for The Treatment of CMV Infection or Persistent CMV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation", - "phase": "Phase 2", - "drugs": "['CMVpp65 Specific T-cells']", - "drugs_list": [ - "CMVpp65 Specific T-cells" - ], - "diseases": "['CMV Infection', 'Persistent CMV Viremia']", - "diseases_list": [ - "CMV Infection", - "Persistent CMV Viremia" - ], - "enrollment": "41.0", - "inclusion_criteria": "inclusion criteria: \n\n Each patient must satisfy at least one of the following criteria: \n\n The patient must have a clinically documented condition associated with CMV (e.g. interstitial pneumonia, hepatitis, retinitis, colitis) Or \n\n The patient must have microbiological evidence of CMV viremia or tissue invasion as attested by viral culture, or detection of levels of CMV DNA in the blood or body fluids consistent with CMV infection. \n\n Patient must also satisfy at least one of the following criteria: \n\n The patient's CMV infection is clinically progressing or CMV viremia is persistent or increasing (as evidenced by quantitation of CMV DNA in the blood) despite two weeks induction therapy with antiviral drugs. \n\n Or \n\n The patient has developed CMV viremia as attested by viral culture, or detection of levels of CMV DNA in blood or body fluids while receiving prophylactic doses of antiviral drugs to prevent CMV infection post transplant. \n\n Or \n\n The patient is unable to sustain treatment with antiviral drugs due to drug associated toxicities (e.g. myelosuppression [ANC< 1000\u03bcl/ml without GCSF support] or nephrotoxicity [corrected creatinine clearance \u2264 60 ml/min/1.73 m^2 or serum creatinine > 2 mg/dl]) CMV infections are life threatening, and may involve multiple organ systems such as the lungs, liver, gastrointestinal tract, hematopoietic and central nervous systems. Antiviral drugs used for treatment may also compromise renal and hematopoietic function. Therefore, dysfunctions of these organs will not affect eligibility for this protocol. \n\n Patients must meet the following clinical criteria to receive CMVpp65-CTL infusions \n\n Stable blood pressure and circulation, not requiring pressor support \n\n Evidence of adequate cardiac function as demonstrated by EKG and/or echocardiography. \n\n A life expectancy of at least 3 weeks, even if requiring artificial ventilation. \n\n There are no age restrictions \n\n Patient must also satisfy at least one of the following criteria: \n\n The patient's HCT donor has not been previously infected by or sensitized to CMV (e.g. a cord blood transplant or a marrow or PBSC transplant from a seronegative donor). \n\n The patient's HCT donor, if seropositive, is either not available or not willing to provide leukocytes for generation of CMV-specific T-cells. \n\n There are CMVpp65-specific T-cells available in appropriate doses in the MSKCC Adoptive Immune T-cell Therapy Bank that are matched with the patient for 1 HLA allele and that exhibit CMVpp65-specific cytotoxic activity that is restricted by an HLA allele shared by the patient \n\n ", - "exclusion_criteria": ": \n\n Patients requiring high doses of glucocorticosteroids (\u2265 0.3 mg/kg prednisone or its equivalent) \n\n Patients who are moribund \n\n Patients with other conditions not related to CMV infection (e.g. uncontrolled bacterial sepsis or invasive fungal infection) which are also life-threatening and which would preclude evaluation of the effects of a T-cell infusion. \n\n Patients who are pregnant", - "brief_summary": "The purpose of this study is to see how well transfusions of T-cells work in treating CMV. Tcells are a type of white blood cell that helps protect the body from infection. A transfusion is the process by which blood from one person is transferred to the blood of another. In this case, the T-cells are made from the blood of donors who are immune to CMV. The T-cells are then grown and taught to attack the CMV virus in a lab.", - "NCTID": "NCT02136797" - }, - { - "brief_title": "Immune Response to Cytomegalovirus", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cytomegalovirus Infections']", - "diseases_list": [ - "Cytomegalovirus Infections" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18-65 \n\n CMV seropositive \n\n Informed consent given \n\n ", - "exclusion_criteria": ": \n\n CMV seronegative \n\n Abnormal blood counts (hemoglobin less than 12 g/dl, platelets less than 150,000/ul, absolute neutrophil count less than 1,500/ul, absolute lymphocyte count less than 1,000/ul) \n\n Known history of heart, lung, kidney, liver, or bleeding disorder \n\n Diagnosis of HIV infection \n\n Diagnosis or suspicion of immunodeficiency state \n\n History of intravenous drug use \n\n Currently pregnant", - "brief_summary": "This study will evaluate immune responses against cytomegalovirus (CMV). About 80 percent of adults have been exposed to this virus. CMV typically remains dormant (inactive) in the body, causing no problems. In people with immune suppression, however, the virus can become reactivated and cause life-threatening pneumonia. The knowledge gained from this study may be useful in developing ways to improve immune responses to CMV in stem cell transplant recipients.~Healthy normal volunteers between 18 and 65 years of age who have been exposed to cytomegalovirus are eligible for this study. Candidates will be screened with a medical history and blood tests. Those enrolled will provide a 30-milliliter (6-tablespoon) blood sample once a week for 4 weeks and a final sample 2 months later. The blood will be used to design a test to detect immune responses against CMV and determine the differences in these responses among healthy individuals.", - "NCTID": "NCT00034437" - }, - { - "brief_title": "Long Term Use of Valganciclovir for Prophylaxis of CMV Disease in Kidney and Pancreas Transplant Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['CMV Disease', 'Viral Resistance', 'Rejection', 'Death']", - "diseases_list": [ - "CMV Disease", - "Viral Resistance", - "Rejection", - "Death" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n 1) Age greater than 18 years 2) WBC greater than 2000/mm3 with ANC greater than 500/mm3 3) Platelet count greater than 50,000/mm3 4) Hematocrit greater than 24 5) Life expectancy greater than 1 year as determined by investigator 6) Females must have a negative pregnancy test and any sexual partner must also agree to practice a barrier and/or hormonal method of birth control while participating in this study and for 90 days after. Females must agree to have a pregnancy test if a menstrual cycle is missed, and if positive, this must be reported. \n\n - \n\n ", - "exclusion_criteria": ": \n\n Patients receiving systemic therapy for acute opportunistic infection at time of enrollment \n\n Patients receiving investigational drugs \n\n Patients with malignancies within the last 5 years with the exception of excised basal or squamous cell skin cancers \n\n Patients with active substance abuse or other condition that would impair compliance \n\n Patients who are unable to give informed consent \n\n Any patient with a creatinine clearance < 40 after delayed graft function and or post-transplant ATN has completely resolved, or the patient is deemed not to have the prospect of any further improvement of creatinine clearance (>40) as would occur with resolving ATN. \n\n Persistent ANC < 1,000 for 2 consecutive weeks despite treatment with G-CSF \n\n Any female patient who plans to become pregnant within one year", - "brief_summary": "CMV viral disease negatively affects transplant patients. CMV is the most prevalent infection in transplant patients and 3 month drug regimens to prevent the virus have been mostly unsuccessful, usually after the drug has been stopped, the patient develops the viral disease. Extended use of anti-viral drugs may, in fact, may lead to the development of resistant virus. We hypothesize that extended use (12 months) of valganciclovir (Valcyte\u2122)will not only be efficacious but will not be associated with the development of resistant CMV.~Sample Size: 100 patients at 3 sites have been enrolled~Patient Selection: Adult (>18 years) recipients of cadaveric or living donor kidneys, pancreas, or combine kidney-pancreas transplants.~Immunosuppression: To be determined according to each center's standard protocol (s).~Study Drug: Valcyte\u2122 Days 0 - 90: All Patients, 900 mg QD~Days 91 - 365:~Group 1: 900 mg QD Group 2: 450 mg QD~Assessment of Valgancicovir (Valcyte\u2122)Resistant CMV : Serial serum samples (at transplant, 6 weeks, and 3, 6, 9 and 12 months post-transplant) for PCR amplification and DNA sequence analysis from detectable CMV to identify the presence of mutations within the UL97 and UL54 genes.~Other Analyses:~Additional information will be evaluated relating to the development of CMV disease, development of ganciclovir toxicity, graft rejection or graft loss and patient death. Preliminary information regarding the predictive value of DNA assays for the development of CMV disease will be evaluated.", - "NCTID": "NCT00225394" - }, - { - "brief_title": "Tissue Biopsy and Imaging Studies in HIV-Infected Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['HIV', 'ICL', 'Healthy Volunteers']", - "diseases_list": [ - "HIV", - "ICL", - "Healthy Volunteers" - ], - "enrollment": "635.0", - "inclusion_criteria": "inclusion criteria: \n\n Greater than or equal to 18 years old. \n\n Ability to sign informed consent. \n\n For women of child-bearing potential, negative result on a serum or urine pregnancy test within 1 week prior to the procedure. \n\n Willingness to allow storage of blood or biopsy samples for possible future use to study HIV/AIDS, related diseases or the immune system; willingness to permit HLA testing. \n\n FOR PATIENTS UNDERGOING BIOPSIES: \n\n No medical contraindication to tonsillar, lymph node, or intestinal biopsy. \n\n For tonsillar biopsy, presence of visible tonsillar tissue; for lymph node biopsy, palpable lymph nodes. \n\n No aspirin or piroxicam (Feldene) for 10 days prior to the procedure; other non steroidal anti-inflammatory drugs (e.g. ibuprofen) must be discontinued the day prior to the procedure. Acetaminophen [Tylenol] is permitted at any time. \n\n FOR PATIENTS UNDERGOING BAL: \n\n Hematocrit greater than 27 percent, platelets greater than 50,000/ml. \n\n Baseline pulse-oximetry recording of 94 percent or greater unless clinical indication for bronchoscopy. \n\n No medical contraindication to bronchoscopy. \n\n In addition to the above: \n\n FOR HIV POSITIVE VOLUNTEERS: \n\n HIV infection must be confirmed by ELISA and western blot or dot blot. For patients with acute HIV infection and negative HIV serology, plasma HIV viral load greater than 10,000 copies/ml. \n\n FOR HEALTHY VOLUNTEERS: \n\n No underlying significant medical problem, especially an immunodeficiency or autoimmune disease, or an underlying problem requiring immunosuppressive therapy. \n\n Absence of HIV infection as confirmed by negative ELISA and, if indicated, western blot or dot blot. \n\n FOR ICL PATIENTS: \n\n Patients must meet the definition of ICL according to the CDC criteria: documented absolute CD4 T lymphocyte count of less than 300 cells per cubic millimeter or of less than 20 percent of total T cells on more than one occasion usually two to three months apart, without evidence of HIV infection or any defined immunodeficiency or therapy associated with depressed levels of CD4 T cells. \n\n Absence of HIV infection as confirmed by negative ELISA and, if indicated, western blot or dot blot. \n\n ", - "exclusion_criteria": ": \n\n FOR ALL VOLUNTEERS UNDERGOING BIOPSIES: \n\n Platelet count less than 75,000 platelets/mm(3). \n\n PT or PTT prolonged by greater than 2 seconds unless patient has documented lupus anticoagulant/anti-phospholipid syndrome, which is not associated with an increased bleeding risk \n\n Known underlying bleeding disorder. \n\n Pregnancy. \n\n FOR HIV-POSITIVE OR ICL VOLUNTEERS FOR LYMPH NODE BIOPSIES: \n\n Use of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy. \n\n FOR ALL VOLUNTEERS FOR INTESTINAL BIOPSIES: \n\n Use of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy. \n\n Significant heart valve abnormalities. \n\n Presence of pacemaker, artificial joint or vascular surgery graft. \n\n FOR ALL VOLUNTEERS FOR BAL: \n\n Use of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy. \n\n Pregnancy. \n\n Any medical condition for which the investigators believe bronchoscopy may be contraindicated. \n\n Allergy to lidocaine. \n\n History of asthma requiring therapy.", - "brief_summary": "This study will examine tissue from the tonsils, lymph nodes and large bowel of HIV-infected patients to investigate changes in viral load and certain white blood cells during treatment.~Normal volunteers and HIV-infected patients 18 years of age or older may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood and urine tests and possibly an electrocardiogram (EKG). Blood tests may include HLA typing, a genetic test of immune system markers.~Participants may undergo the following procedures:~Blood tests (patients and volunteers)~Biopsies The frequency of biopsies for given patients may vary, depending on their specific therapy. Typically, biopsies are done at a single time, or for patients starting a new therapy, biopsies could be performed before starting therapy, during therapy and possibly after completion of therapy.~Tonsil biopsies (patients and volunteers) Volunteers will have one tonsil biopsy. Patients will have no more than six tonsil biopsies, with no more than three in a 10-day period. The biopsy is done by an ear, nose and throat specialist as an outpatient procedure. The tonsils are numbed with a local anesthetic, and one to four pieces of tissue are extracted.~Lymph node biopsies (patients only) Patients will have no more than four lymph node biopsies, performed no more frequently than once a month. The biopsy is done by a surgeon and may require a 2- to 3-day hospital stay. The skin above the lymph nodes is numbed with a local anesthetic, an incision is made and the tissue is removed. Alternatively, a needle biopsy may be done, in which a small amount of lymph tissue is withdrawn through a special needle injected into the site.~Intestinal biopsies (patients and volunteers) Volunteers will have one intestinal biopsy procedure. Patients may have up to six intestinal biopsy procedures, each separated by at least 10 days. This is done by a gastroenterologist as an outpatient procedure. A flexible tube (sigmoidoscope or colonoscope) with a light and special lens at the tip is inserted into the rectum and large bowel. Wire instruments passed through the tube are used to extract small tissue samples.~Bronchoalveolar lavage (BAL; patients and volunteers) Volunteers and patients will undergo bronchoscopy in which a flexible tube (bronchoscope) with a light and special lens at the tip is inserted through the nose or mouth into the lungs, and the lining of the lung is sampled by washing the airways with small amounts of saline. The procedure is performed by a pulmonologist or critical care specialist, usually as an outpatient.", - "NCTID": "NCT00001471" - }, - { - "brief_title": "Response of Older Adults to Influenza Vaccination With Regard to Cytomegalovirus (CMV) Status", - "phase": "Phase 4", - "drugs": "['Fluarix']", - "drugs_list": [ - "Fluarix" - ], - "diseases": "['Influenza']", - "diseases_list": [ - "Influenza" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n No contraindications to vaccination as specified in the Green Book - Immunisation Against Infectious Disease, HMSO. \n\n Written informed consent obtained \n\n Subject aged no less than 50 years 0 days and no older than 79 years and 364 days at enrollment.", - "exclusion_criteria": "", - "brief_summary": "The study is being undertaken to evaluate responses to seasonal influenza vaccine in older adults with respect to their CMV status. CMV is cytomegalovirus and is an organism that infects many people, but does not usually cause disease in the individual unless they are immunocompromised i.e. their immune system is not working well such as in the case of HIV infection. CMV is believed to have infected up to 80% of individuals in the age group we will be looking at in our study and we are interested in whether this infection affects their responses to vaccination.", - "NCTID": "NCT00442975" - }, - { - "brief_title": "Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Kidney Transplant Recipients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Kidney Transplantation Recipients']", - "diseases_list": [ - "Kidney Transplantation Recipients" - ], - "enrollment": "199.0", - "inclusion_criteria": "inclusion criteria: \n\n age 16 or more \n\n agree with written informed consent \n\n ", - "exclusion_criteria": ": \n\n donor CMV IgG (+) and recipient CMV IgG (-)", - "brief_summary": "CMV is one of the most important opportunistic infection in transplant recipients. In South Korea, more than 95% of adults reveal sero-positivity for CMV IgG. Until now, sero-positivity for CMV IgG before solid organ transplantation is a laboratory test of choice to stratify the risk of CMV reactivation after solid organ transplantation. Theoretically, CMV-specific cell-mediate immune response before solid organ transplantation will further categorize the patients into high or low risk of CMV development after solid organ transplantation. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in kidney transplant candidates to predict the development of CMV infection after kidney transplantation.", - "NCTID": "NCT02025335" - }, - { - "brief_title": "Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Bone Marrow Transplant Recipients (ACE-BMT)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Bone Marrow Transplantation']", - "diseases_list": [ - "Bone Marrow Transplantation" - ], - "enrollment": "88.0", - "inclusion_criteria": "inclusion criteria: \n\n age 16 or more \n\n agree with written informed consent \n\n ", - "exclusion_criteria": ": \n\n no ", - "brief_summary": "CMV is one of the most important opportunistic infection in transplant recipients. In South Korea, more than 95% of adults reveal sero-positivity for CMV IgG. Until now, sero-positivity for CMV IgG before bone marrow organ transplantation is a laboratory test of choice to stratify the risk of CMV reactivation after solid organ transplantation. Theoretically, CMV-specific cell-mediate immune response before and after bone marrow transplantation will further categorize the patients into high or low risk of CMV development after bone marrow transplantation. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in bone marrow transplant candidates to predict the development of CMV infection after transplantation.", - "NCTID": "NCT02081716" - } - ], - "2": [ - { - "brief_title": "Prevalence of Pneumocystis Jirovecii and of Cytomegalovirus in Bronchial Wash Fluid of Patients Undergoing Bronchoscopy", - "phase": "", - "drugs": "['laboratory testing of PCP and CMV genetic material']", - "drugs_list": [ - "laboratory testing of PCP and CMV genetic material" - ], - "diseases": "['Patients Scheduled for Bronchoscopy']", - "diseases_list": [ - "Patients Scheduled for Bronchoscopy" - ], - "enrollment": "93.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients undergoing Fiberoptic Bronchoscopy for any indication and signing an informed consent form. \n\n ", - "exclusion_criteria": ": \n\n Hypoxemia < 90% at Room air", - "brief_summary": "The purpose of this study is to determine the incidence of the carriage state (asymptomatic colonization) with Pneumocystis Jirovecii (Pneumocystic Carinii Pneumonia, PCP) and Cytomegalovirus (CMV)in the human lung. These are pathogens causing pneumonia in patients with suppressed immune system, but not known to cause disease in otherwise normal people. The investigators hypothesis is that a carriage state exists for these two pathogens. To test this hypothesis the investigators will examine bronchoalveolar lavage fluid for genetic material of these two pathogens. The study population will be patients undergoing fiberoptic bronchoscopy and lavage for indications other than diagnosis of a presumed opportunistic infection.", - "NCTID": "NCT01395498" - }, - { - "brief_title": "Quantiferon - Cytomegalovirus (CMV) and the Prediction of CMV Infection In High Risk Solid Organ Transplant Recipients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cytomegalovirus Infection']", - "diseases_list": [ - "Cytomegalovirus Infection" - ], - "enrollment": "131.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female patients who fulfill the following criteria are eligible for inclusion. \n\n CMV D+/R- liver, kidney, heart, pancreas, lungor combined transplant recipients \n\n All eligible patients must be scheduled to receive 3 months of either valganciclovir, oral ganciclovir, or intravenous ganciclovir prophylaxis. \n\n Able to give written informed consent \n\n Are willing and able to comply with the protocol \n\n Age >=18 years \n\n ", - "exclusion_criteria": ": \n\n - Patient unwilling or unable to give informed consent", - "brief_summary": "Cytomegalovirus (CMV) is a common cause of illness in patients who have undergone a transplant. Serious infections due to CMV can affect many parts of the body including the lungs, the gut, and the liver. Since transplant recipients are at risk for CMV or have evidence of infection with CMV, they are given an antiviral drug (usually ganciclovir or valganciclovir). Despite this, there are a chance that CMV infection may cause problems in the future. The purpose of this study is to assess how well patients'immune systems responds to the CMV virus, so that in the future it may be possible to predict which patients are at highest risk of CMV.", - "NCTID": "NCT00817908" - }, - { - "brief_title": "Study of Lung Proteins in Patients With Pneumonia", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pneumonia', 'Pulmonary Disease', 'Lung Disease']", - "diseases_list": [ - "Pneumonia", - "Pulmonary Disease", - "Lung Disease" - ], - "enrollment": "750.0", - "inclusion_criteria": "inclusion criteria: \n\n All eligible patients undergoing diagnostic bronchoscopy who provide consent for proteomic analysis of BAL fluid supernatant and chart review of patient characteristics will be included in this study. \n\n A parent/guardian may provide consent for a child age 17 or under and a Legally Authorized Representative (LAR) may provide consent for adults unable to consent. \n\n ", - "exclusion_criteria": ": \n\n Patients undergoing bronchoscopy but not wanting to participate with either the chart review or the proteomic analysis of BAL fluid supernatant will be excluded.", - "brief_summary": "This study will examine the different types of proteins present in the lungs of patients with pneumonia to explore the causes of different types of the disease. Pneumonia is a condition that causes lung inflammation AND is often caused by an infection. It is usually diagnosed by lung x-rays and listening to the chest with a stethoscope. This method can diagnose pneumonia, but it does not provide information on the cause of the inflammation - information that might be helpful in guiding treatment. This study will measure proteins in the lungs of patients to see if certain proteins are associated with specific forms of pneumonia, and can thus serve as biomarkers for disease.~Patients undergoing diagnostic bronchoscopy at the NIH Clinical Center may participate in this study. Patients will undergo bronchoscopy and bronchoalveolar lavage as scheduled for their medical care. For this procedure, the patient's mouth and throat are numbed with lidocaine; a sedative may be given for comfort. A thin flexible tube called a bronchoscope is advanced through the nose or mouth into the lung airways to examine the airways carefully. Saline (salt water) is then injected through the bronchoscope into the air passage, acting as a rinse. A sample of fluid is then withdrawn for microscopic examination. Researchers in the current study will use some of the fluid obtained from the lavage to examine for protein content.~In addition to the bronchoscopy and bronchoalveolar lavage, participants will have about 2 tablespoons of blood drawn to compare blood test results with the results of the lung washings. Patients' medical records will be reviewed to obtain information on past medical history, current medical treatment, vital signs, and results of x-ray tests.~...", - "NCTID": "NCT00077909" - }, - { - "brief_title": "Collection of Lung Fluid and Tissue Samples for Research", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Leukocyte Disorders', 'Respiratory Tract Diseases', 'Bronchoscopy']", - "diseases_list": [ - "Leukocyte Disorders", - "Respiratory Tract Diseases", - "Bronchoscopy" - ], - "enrollment": "550.0", - "inclusion_criteria": "HEALTHY VOLUNTEER inclusion criteria FOR BRONCHOSCOPY AND BRONCHOSCOPIC PROCEDURES: \n\n 18 to 75 years of age \n\n Enrolled without regard to gender, race, or ethnicity \n\n NIH employees or non-employees eligible \n\n Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process \n\n Able and willing to complete the informed consent process \n\n Able and willing to arrange to have another person drive them home after the procedure \n\n Able and willing not to eat or drink anything for 6 hours prior and 2 hours after the procedure \n\n Willing to donate blood and respiratory tract samples for storage to be used for future research \n\n In good general health without clinically significant medical history \n\n Physical examination without clinically significant findings \n\n Screening laboratory tests without clinically significant abnormalities: \n\n Complete blood count with differential \n\n Serum chemistries including creatinine, blood urea nitrogen, glucose, liver enzymes and function tests, electrolytes \n\n HIV test and hepatitis serologies (HBsAg; HCV) if status is unknown \n\n Prothrombin time, partial thromboplastin time \n\n Urinalysis \n\n Female subjects must have negative urine pregnancy test within 1 week of participation and continue birth control practices prior to participation \n\n Chest radiograph (CXR) (if the subject has not had a CXR or computerized tomography [CT] scan of the chest within the prior7 days) \n\n Pulse oximetry \n\n Electrocardiogram (ECG) \n\n Treadmill exercise stress test (as indicated for history of angina or abnormalities on ECG) \n\n HEALTHY VOLUNTEER ", - "exclusion_criteria": " FOR BRONCHOSCOPY AND BRONCHOSCOPIC PROCEDURES: \n\n Less than 18 or greater than 75 years old \n\n A smoking history of 10 pack-years or more, a current smoker, or tobacco free for less than a year. \n\n Positive HIV status. Subjects must have a negative FDA-approved HIV blood test. [Note: Results of HIV enzyme-linked immunosorbent assay (ELISA) will be documented, but a negative HIV polymerase chain reaction (PCR) test result will be sufficient for eligibility screening of subjects with positive HIV ELISA that is due to prior participation in an HIV vaccine study] \n\n Acute or chronic hepatitis based on viral hepatitis serologies \n\n Pregnancy or breastfeeding \n\n Any active medical problems especially bleeding disorders, significant bruising or bleeding difficulties with intramuscular (IM) injections or blood draws, use of anticoagulants, or pulmonary disorders including asthma \n\n History of allergic reaction to lidocaine, sedative medications like Valium Trademark or Versed Trademark, or narcotic medications like morphine or fentanyl \n\n Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past three months. (Note that use of corticosteroid nasal spray for allergic rhinitis, topical corticosteroids for an acute uncomplicated dermatitis, or short-acting beta-agonists in controlled asthmatics is not excluded). \n\n Use of platelet inhibitors including aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) within 7 days of procedure \n\n Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer s ability to give informed consent \n\n PATIENT inclusion criteria FOR BRONCHOSCOPY AND BRONCHOSCOPIC PROCEDURES \n\n 18 to 75 years of age inclusive \n\n Known or suspected respiratory infections or infection susceptibility \n\n Enrolled without regard to gender, race, or ethnicity \n\n Must be enrolled in a concurrent NIH protocol and under the care of a primary physician outside of the NIH \n\n Able and willing to complete informed consent process \n\n Able and willing to arrange to have another person drive them home after the procedure \n\n Able and willing not to eat or drink anything for 6 hours prior and 2 hours after the procedure \n\n Willing to donate blood and respiratory tract samples for storage to be used for future research \n\n PATIENT ", - "brief_summary": "This study will collect fluid and tissue specimens from the lungs and nose of healthy people and people with a history of lung infections. The specimens will be examined for differences between the two groups that may be associated with susceptibility to certain infections.~Healthy normal volunteers and people with a history of lung infections between 18 and 75 years of age who are followed at NIH may be eligible for this study.~Participants undergo the following procedures:~Medical history and physical examination.~Blood and urine tests.~Electrocardiogram (ECG) and chest x-ray.~Treadmill exercise stress test (for people over 45 years old with a history of chest pain or ECG abnormalities).~Bronchoscopy: The subject s nose and throat are numbed with lidocaine and a sedative is given for comfort. A thin flexible tube called a bronchoscope is advanced through the nose or mouth into the lung airways to examine the airways carefully.~Fluid collection during the bronchoscopy using one of the following methods:~Bronchoalveolar lavage: Salt water is injected through the bronchoscope into the lung and immediately suctioned out, washing off cells lining the airways.~Bronchial brushings: A brush-tipped wire enclosed in a sheath is passed through the bronchoscope and a small area of the airway tissue is gently brushed. The brush is withdrawn with some tissue adhering to it.~Endobronchial biopsies: Small pinchers on a wire are passed through the bronchoscope and about 1 to 2 millimeters of tissue is removed.~Nasal scrape: A small device is used to scrape along the inside of the nose to collect some cells.", - "NCTID": "NCT00471250" - }, - { - "brief_title": "A Comparison of HIV-Infected Patients With and Without Opportunistic (AIDS-Related) Infection", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cytomegalovirus Infections', 'Cytomegalovirus Retinitis', 'Pneumonia, Pneumocystis Carinii', 'HIV Infections']", - "diseases_list": [ - "Cytomegalovirus Infections", - "Cytomegalovirus Retinitis", - "Pneumonia", - "Pneumocystis Carinii", - "HIV Infections" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria \n\n Patients may be eligible if they: \n\n Are HIV positive (except Group 3b). \n\n Are at least 13 years old (consent of parent or guardian required if under 18). \n\n Patients may be eligible for Group 1a if they: \n\n Have acute PCP. \n\n Have never received potent anti-HIV drugs or have not received potent anti-HIV drugs for at least 8 weeks prior to getting PCP. \n\n Have a CD4 cell count below 200 cells/mm3. \n\n Patients may be eligible for Group 1b if they: \n\n Have CMV disease. \n\n Meet 1 of the following requirements: (1) have never received potent anti-HIV drug containing a protease inhibitor (PI) or a nonnucleoside reverse transcriptase inhibitor (NNRTI), (2) have not received potent anti-HIV drugs for at least 8 weeks before getting CMV disease, or (3) have been on stable anti-HIV therapy for at least 3 months with no new anti-HIV drugs started before CMV disease returned. \n\n Have a CD4 cell count below 50 cells/mm3 if patient received anti-HIV drugs at any time in the past. \n\n Have an eye exam (patients with CMV retinitis). \n\n Patients may be eligible for Group 2a if they: \n\n Have a history of PCP. \n\n Are currently receiving potent anti-HIV drugs. \n\n Have been enrolled in ACTG 888. \n\n Have been off drugs to prevent PCP for at least 48 weeks prior to study entry. \n\n Have not developed PCP while on potent anti-HIV drugs. \n\n Have a CD4 cell count above 200 cells/mm3. \n\n Patients may be eligible for Group 2b if they: \n\n Have a history of CMV retinitis. \n\n Are currently receiving potent anti-HIV drugs. \n\n Have been off drugs to prevent CMV retinitis for at least 12 weeks prior to study entry. \n\n Have not developed CMV retinitis while on potent anti-HIV drugs. \n\n Have a CD4 cell count above 50 cells/mm3. \n\n Have an eye exam confirming lack of CMV retinitis activity within 28 days before study entry. \n\n Patients may be eligible for Group 3a if they: \n\n Are CMV-positive. \n\n Have never had PCP or CMV disease. \n\n Have never had a CD4 count below 200 cells/mm3. \n\n Have never taken medications to prevent PCP or CMV disease. \n\n Patients may be eligible for Group 3b if they: \n\n Are HIV-negative. \n\n Are CMV-positive. \n\n (The lay eligibility section reflects changes in the AIDS-related infections treated.) \n\n ", - "exclusion_criteria": " \n\n Patients will not be eligible if they: \n\n Have received a vaccine within 14 days of study entry or plan to receive one during the study. \n\n Have taken GM-CSF, any investigational drugs, or any drugs that might affect the immune system within 30 days of study entry or plan to take 1 of these medications during the study. (Prednisone for patients with PCP and G-CSF is allowed.) \n\n Abuse drugs.", - "brief_summary": "The purpose of this study is to understand how changes in the immune system of HIV-infected patients affect their risk for 3 serious infections: Pneumocystis carinii pneumonia (PCP), cytomegalovirus (CMV) retinitis, or CMV organ disease. The purpose also is to understand how anti-HIV medicines may improve the immune system in these patients. (This purpose reflects a change in the AIDS-related [opportunistic] infections studied.) Presently, HIV-infected patients who have had PCP or CMV disease stay on lifelong therapy to prevent the return of the disease. This study is trying to see if a special lab test can help identify which patients can stop this preventive therapy without having another episode of PCP or CMV organ disease. (This rationale reflects a change in the AIDS-related infections studied.)", - "NCTID": "NCT00005572" - } - ] - }, - { - "patient_id": "sigir-20153", - "patient": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", - "0": [ - { - "brief_title": "Extended Duration of Oral Anticoagulant Therapy After a First Episode of Idiopathic Pulmonary Embolism: a Randomized Controlled Trial. PADIS-PE Study.", - "phase": "Phase 3", - "drugs": "['warfarin', 'placebo of warfarin']", - "drugs_list": [ - "warfarin", - "placebo of warfarin" - ], - "diseases": "['Pulmonary Embolism']", - "diseases_list": [ - "Pulmonary Embolism" - ], - "enrollment": "374.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with a first episode of idiopathic pulmonary embolism who have been treated during 6 months (Plus 30 days or minus 15 days) using Vitamin K antagonist with a INR between 2 and 3. \n\n ", - "exclusion_criteria": ": \n\n Age < 18 \n\n warfarin hypersensibility \n\n unwilling or unable to give written informed consent \n\n distal or proximal deep vein thrombosis \n\n Pulmonary embolism which was provoked by a reversible major risk factor \n\n major thrombophilia (protein C, S or antithrombin deficiency, antiphospholipids antibodies, homozygous factor V Leiden) \n\n previous documented episode of proximal deep vein thrombosis or pulmonary embolism \n\n other indication for anticoagulant therapy (e.g.:atrial fibrillation, mechanic valve) \n\n patient on antithrombotic agent in whom antithrombotic agent should be started again after stopping anticoagulation \n\n pregnancy \n\n women without contraception \n\n planned major surgery in the next 18 months \n\n ongoing cancer or cured cancer in less than 2 years \n\n serious bleeding risk (e.g.: gastric ulcer) \n\n platelet count less than 100 Giga/l \n\n Life expectancy less than 18 months", - "brief_summary": "Rational: After 3 or 6 months of oral anticoagulation for an episode of acute venous thromboembolism (VTE), the risk of recurrent VTE is high (10 to 15% per year) in comparison with a low risk of recurrence if VTE was provoked by a major transient risk factor such as recent surgery (3% per year) independently of the initial presentation (deep vein thrombosis or pulmonary embolism). After a first episode of idiopathic VTE, 3 months of anticoagulation is associated with a very high risk of recurrence (27% per year); however, the benefit-risk of extended duration of anticoagulation (1 to 2 years) remains uncertain, mainly in relation with an increased risk of anticoagulant related bleeding. Therefore, the last ACCP conference group recommended 6 months of oral anticoagulant therapy after a first episode of idiopathic VTE. However, this recommendation is likely to be inadequate for at least two main reasons: (1) no studies compared 2 years to 6 months of anticoagulation after idiopathic VTE; and (2), if the frequency of recurrent VTE is similar after deep vein thrombosis and pulmonary embolism, however, the case fatality rate of recurrent VTE is higher after pulmonary embolism (12%) than after deep vein thrombosis (5%).~Objective : the main objective is to demonstrate that, after 6 months of oral anticoagulation for a first episode of idiopathic pulmonary embolism, 18 months of warfarin therapy is associated with a lower cumulative risk of recurrent VTE and major bleeding in comparison with that on 18 months of placebo. The secondary objectives are: (1) to determine the risk of recurrent VTE after 6 months of warfarin therapy and the presence or the absence of residual lung scan perfusion defect and the persistence or not of elevated D-dimer test; and (2), to determine the impact of extended duration of anticoagulation on the risk of VTE after stopping anticoagulant therapy on a follow-up of 2 years.~Method : French multicenter double blind randomized controlled trial. Inclusion and exclusion criteria and pulmonary diagnostic criteria have been defined. After completing 6 months of oral anticoagulation, a lung scan and D-dimer testing are performed; the investigators and the patients will be unaware of the results of these tests. Then, patients are randomized to receive 18 months of warfarin therapy or 18 months of placebo (the dose of placebo will be adapted according to false computer generated INR). The investigators, the radiologists and the patients are blinded of the treatment allocation. The project will be submitted to national ethical committee and written consent will be obtained from all included patients.~Required number of patients: the expected cumulative frequency of recurrent VTE and major bleeding over 18 months is 4.5% while on warfarin therapy and 16% while on placebo. For a \u03b1 risk of 5% (to falsely conclude to a true difference) and a \u03b2 risk of 10% (to falsely conclude to an absence of difference), 178 patients per group should be included. As 5% of patients are expected to be loss, a total of 374 patients is required.~Feasibility: about 50 patients per year are hospitalized in our department of medicine in Brest for an acute episode of idiopathic pulmonary embolism. Four additional centers will participate to the study and have a similar recruitment: HEGP (Pr Meyer, Dr Sanchez), CHU Antoine B\u00e9cl\u00e8re (Dr Parent, Pr Simmoneau), CHU Saint Etienne (Pr Mismetti, Pr D\u00e9cousus), CHU Grenoble (Pr Pison, Pr Carpentier). The study will be coordinated by the Clinical Center of Investigation of Brest Hospital; true and false INR will be generated by the clinic of anticoagulant of Ile de France (Dr Cambus).~Clinical implications: the first consequence of the study is to demonstrate that 6 months of warfarin therapy is inadequate and should be continued for at least 18 additional months after a first episode of idiopathic pulmonary embolism. This study has also the potential to confirm or not the contribution of lung scan and D-dimer testing to appreciate the risk of recurrent VTE after stopping anticoagulant therapy. Lastly, the medical economical impact of such therapeutic management will be evaluated.", - "NCTID": "NCT00740883" - }, - { - "brief_title": "Long-term Treatment for Cancer Patients With Deep Venous Thrombosis or Pulmonary Embolism", - "phase": "Phase 3", - "drugs": "['low molecular weight heparin', 'vitamin K antagonists']", - "drugs_list": [ - "low molecular weight heparin", - "vitamin K antagonists" - ], - "diseases": "['Venous Thromboembolism', 'Neoplasms']", - "diseases_list": [ - "Venous Thromboembolism", - "Neoplasms" - ], - "enrollment": "56.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with cancer and confirmed pulmonary embolism (PE) or deep vein thrombosis (DVT) of the leg who have been treated for minimally 6 and maximally 12 months with therapeutic doses of anticoagulants, i.e. LMWH or VKA or a new anticoagulant in a trial \n\n Written informed consent \n\n Indication for long-term anticoagulant therapy (e.g. because of metastasized disease, chemotherapy) \n\n ", - "exclusion_criteria": ": \n\n Legal age limitations (country specific), minimum age at least 18 years \n\n Indications for anticoagulant therapy other than DVT or PE \n\n Any contraindication listed in the local labeling of LMWH or VKA \n\n Childbearing potential without proper contraceptive measures, pregnancy or breastfeeding \n\n Life expectancy <3 months", - "brief_summary": "Background~Patients with cancer and a first deep venous thrombosis of the leg or pulmonary embolism (venous thromboembolism, VTE) are generally treated with low molecular weight heparin (LMWH)injections for 6 months, since this treatment is associated with a reduced incidence of recurrent VTE compared to vitamin K antagonists (VKA). It is recommended that patients with active malignancy (metastatic cancer and/or ongoing cancer treatment)continue anticoagulant treatment. However, it is unknown whether LMWH is still superior compared to VKA for the long-term anticoagulant treatment.~Aim~The aim of this study is to evaluate whether low-molecular-weight heparin more effectively reduces recurrent VTE compared to vitamin K antagonists in patients with cancer who have already completed 6 to 12 months of anticoagulant treatment because of deep venous thrombosis of the leg or pulmonary embolism.~Hypothesis~The investigators hypothesize that LMWH is more effective compared to VKA in the long-term treatment of VTE in cancer patients who have already been treated for 6-12 months with anticoagulants.~Design~This is a multicenter, multinational, randomized, open label trial.~Patients~Patients with a malignancy (all types, solid and hematological) who have received 6-12 months of anticoagulation for VTE and have an indication for continuing anticoagulation, will be randomly assigned to six additional months of LMWH or VKA. LMWH will be administered in a weight-adjusted scheme, with 65-75% of therapeutic doses. All types of LMWH and VKA are allowed, as long as weight adjusted dosing is possible for LMWH. The target INR will be 2.0-3.0. The primary efficacy outcome is symptomatic recurrent VTE, i.e. deep vein thrombosis and pulmonary embolism. The primary safety outcome is major bleeding.~Sample size~A total of 65 to 87 recurrent VTE events are needed to show a 50% reduction with LMWH as compared to VKA (type I error 0.05, two-sided, power respectively 80 and 90%). To observe 75 events, with a 10% event rate per half year in the VKA arm and 5% in the LMWH arm a total of 1000 patients will need to be included.~Organisation~Outcomes will be adjudicated by a central adjudication committee. A steering committee will be formed, preferably consisting of one member of every participating center. An electronic case report form will be used for data collection. Also, an electronic trial master file will be used.", - "NCTID": "NCT01164046" - }, - { - "brief_title": "Study of Diagnosis and Pathophysiology of Pulmonary Embolism (APE 1 Trial)", - "phase": "", - "drugs": "['Scintigraphic interpretation']", - "drugs_list": [ - "Scintigraphic interpretation" - ], - "diseases": "['Pulmonary Embolism', 'Right Heart Strain']", - "diseases_list": [ - "Pulmonary Embolism", - "Right Heart Strain" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria: \n\n Referred from clinical departments at Odense University Hospital \n\n Referred to the Departments of Nuclear Medicine or Radiology for diagnostic evaluation of suspected pulmonary embolism \n\n Referred for lung scintigraphy, spiral computer tomography, or pulmonary angiography \n\n ", - "exclusion_criteria": ": \n\n Age below 18 \n\n Contrast allergy \n\n Pregnancy \n\n S-Creatinine above 200 micromol/L \n\n Metformin treatment \n\n Fibrinolytic or surgical therapy between examinations \n\n No informed consent \n\n Withdrawn consent \n\n Failed logistics (more than 24 hours between examinations) \n\n No conclusive pulmonary angiography", - "brief_summary": "The purpose of this study is to~investigate which method and criterion for diagnosing pulmonary embolism is the best and~determine the relationship between blood vessel constriction and clot size in patients developing heart failure", - "NCTID": "NCT00302601" - }, - { - "brief_title": "Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer", - "phase": "", - "drugs": "['LEFt clinical decision rule']", - "drugs_list": [ - "LEFt clinical decision rule" - ], - "diseases": "['Pregnancy', 'Deep Vein Thrombosis']", - "diseases_list": [ - "Pregnancy", - "Deep Vein Thrombosis" - ], - "enrollment": "366.0", - "inclusion_criteria": "inclusion criteria: \n\n Unselected pregnant women (as self-reported by patient and/or previously documented positive beta hCG on urine or serum pregnancy tests) with \n\n Suspected acute symptomatic deep vein thrombosis, defined as: \n\n New leg swelling or edema with onset in the last month or, \n\n New leg pain (buttock, groin, thigh or calf) with onset in the last month. \n\n ", - "exclusion_criteria": ": \n\n Below the age of legal consent in jurisdiction of residence (18 years old for Quebec and 16 years old for rest of Canada) \n\n Baseline imaging (imaging done after a minimum of 3 months of treatment for prior proximal DVT) not available if suspected recurrence in the same leg as prior \n\n Unable or unwilling to provide informed consent \n\n Concomitant symptoms of suspected pulmonary embolism (chest pain or shortness of breath or syncope/pre-syncope or unexplained tachycardia) \n\n Therapeutic anticoagulant more than 48 hours.", - "brief_summary": "This is prospective cohort study in pregnant women who present with signs and symptoms of possible deep vein thrombosis (DVT). All patients will have the same method of assessment of their DVT symptoms (the LEFt clinical decision rule will be applied and D-dimer test will be done) to determine if a compression ultrasound is required. All patients will be followed for a period of 3 months.", - "NCTID": "NCT02507180" - }, - { - "brief_title": "Characteristics of Patients With Missed Pulmonary Embolism in the ED: A Three Year Experience", - "phase": "", - "drugs": "['detection of pulmonary embolism']", - "drugs_list": [ - "detection of pulmonary embolism" - ], - "diseases": "['Missed Pulmonary Embolism at the Emergency Department']", - "diseases_list": [ - "Missed Pulmonary Embolism at the Emergency Department" - ], - "enrollment": "1251.0", - "inclusion_criteria": "inclusion criteria: \n\n patients 18 years of age or older, \n\n presented to the ED between January 2011 and March 2014, \n\n who received an ECG or any form of thoracic imaging. \n\n ", - "exclusion_criteria": ": \n\n patients below 18 years of age, as well as patients referred to the ED with suspected PE by departments within UHBS, other hospitals, or other healthcare providers", - "brief_summary": "The clinical presentation of acute pulmonary embolism ranges from mild dyspnea and cough to shock or sustained hypotension but it also may even be asymptomatic and diagnosed by imaging procedures performed for other purposes. (1) Depending on the clinical presentation, the case fatality rate for acute pulmonary embolism ranges from 1% up to 60%. Due to the often non-specific presentation, especially in mild to moderate acute pulmonary embolism PE is often underdiagnosed. Chest pain and shortness of breath are the two most common symptoms associated with pulmonary embolism, together these symptoms are responsible for approximately 10 million emergency department visits in the United States of America (US) (2). The aim of this study was to determine the sensitivity and specificity of diagnosing pulmonary embolism (PE) at the emergency department (ED) of the University Hospital Basel and the investigators have therefore retrospectively analyzed all cases with excluded or proven PE in our institution in the last three years. Data sets from the institute of radiology, the institute of pathology and the ED are consistently available from January 2011 until the present day and were screened for pulmonary embolism in discharge reports. Data from the ED include all patients between January 2011 and December 2013 that presented to the ED and received either an ECG or any form of thoracic imaging. Particular attention was paid to patients with PE in the discharge report. The third set of data includes all patients with PE as cause of death or as a secondary diagnosis in the autopsy report. After comparing the three sets of data to each other the investigators tried to determine the sensitivity and specificity of PE diagnosis at the ED respectively the rate of missed diagnoses. A PE was seen as missed if it is detected 24h after the patient presented to the ED or if it was detected at another department after the patient was transferred from the ED.", - "NCTID": "NCT02476721" - }, - { - "brief_title": "Epoprostenol in Pulmonary Embolism", - "phase": "Phase 4", - "drugs": "['epoprostenol']", - "drugs_list": [ - "epoprostenol" - ], - "diseases": "['Acute Pulmonary Embolism']", - "diseases_list": [ - "Acute Pulmonary Embolism" - ], - "enrollment": "14.0", - "inclusion_criteria": "inclusion criteria: \n\n acute (symptoms <24 hrs) with right ventricular dilatation (>30 mm end diastolic, systolic PAP > 50 mmHg, \n\n absence of right ventricular wall hypertrophy) \n\n ", - "exclusion_criteria": ": \n\n age below 18 years or above 70 years \n\n body mass index >35 kg/m2 \n\n duration of symptoms >24 hours (since onset or acute increase in symptoms) \n\n severe circulatory shock (systemic blood pressure systolic <80 mmHg, or diastolic blood pressure <45 mmHg) or respiratory failure, requiring mechanical ventilation. \n\n patients who, in the opinion of the supervising physician, require thrombolytic therapy. \n\n severe pre-existent cardiopulmonary disease (heart failure, obstructive pulmonary disease, emphysema) \n\n atrial fibrillation \n\n refusal or inability to give informed consent", - "brief_summary": "You are admitted to hospital because of pulmonary embolism. You are treated with anticoagulants.~The investigators know that, despite this treatment, pulmonary embolism can be a threat especially if heart function is compromized.~The investigators investigate a well known study drug (epoprostenol) on top of regular treatment with anticoagulants, to see if heart function can be optimized", - "NCTID": "NCT01014156" - }, - { - "brief_title": "Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery", - "phase": "Phase 1; Phase 2", - "drugs": "['LMWH: Dalteparin', 'Placebo']", - "drugs_list": [ - "LMWH: Dalteparin", - "Placebo" - ], - "diseases": "['Venous Thromboembolism', 'Lung Neoplasms', 'Pulmonary Embolism']", - "diseases_list": [ - "Venous Thromboembolism", - "Lung Neoplasms", - "Pulmonary Embolism" - ], - "enrollment": "102.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients must be at least 18 years of age. \n\n Patient may be of either gender. \n\n Patients must be diagnosed with resectable lung cancer or metastatic lung disease eligible to complete metastasectomy. \n\n Patients must be undergoing one of the following surgeries: segmentectomy, wedge resection, lobectomy, bilobectomy or pneumonectomy. \n\n Patients must be competent to understand consent documents. \n\n ", - "exclusion_criteria": ": \n\n All patients with known allergic or anaphylactic reaction to contrast dye, heparin or low molecular weight heparin (LMWH). \n\n Patients must not be under current anticoagulation for venous thromboembolism or other medical conditions. \n\n Patients must not have known renal impairment (defined as estimated glomerular filtration rate of less than 30ml/min/m2 as calculated by the Cockcroft-Gault method) either pre-operatively or as identified based on blood work obtained prior to the scheduled 30-day post-operative scan. \n\n Patients must not have known hepatic failure, with international normalized ratio (INR) of >1.5. \n\n Patients with history of, or ongoing liver disease, manifested as ascites or previous peritoneal tapping for ascites. \n\n Patients must not be pregnant or planning to become pregnant. \n\n Patients must not have been diagnosed or treated for VTE in the past 3 months prior to surgery. \n\n Patients must not have a known, objectively confirmed bleeding disorder. \n\n Patients must not have a present or previous increase risk of haemorrhage. \n\n Patients must not have a history of previous heparin induced thrombocytopenia. \n\n Baseline platelet count <75,000 but transient, recovered thrombocytopenia associated with chemotherapy will not be a basis for exclusion. \n\n Patients must not have previously inserted inferior vena cava filter.", - "brief_summary": "After any surgery, there is a risk of venous thromboembolism (VTE), including Deep Vein Thrombosis (DVT) in the major veins of the legs and Pulmonary Embolus (PE) in the lungs. These clots are usually prevented by the administration of low-molecular-weight heparin, a blood thinner that prevents clotting. In most surgical specialties like thoracic or vascular surgery, this treatment is used until patients are discharged from the hospital. However, in orthopaedic surgery, there is strong evidence that longer term preventative treatment up to 35 days after hospital discharge helps to reduce VTE occurrences. In thoracic surgery, there is an even greater risk of developing PE because of the surgical stress, the common presence of cancer and direct damage to blood vessels in the lung during surgery. Despite the potential utility, the use of extended VTE prevention has never been evaluated in the thoracic surgery population. If extended treatment prevents clots, more patients will avoid complications related to VTE. There is currently very limited information available on the incidence of venous thromboembolism (VTE) in patients undergoing lung cancer resection and the utility of extended thromboprophylaxis (ET) in this patient population. Furthermore, in contrast to patients undergoing orthopaedic surgery where ET has become standard of care, duration of thromboprophylaxis is not well defined in this patient population. Therefore, there is a clear need to systematically evaluate the effects of extended VTE prophylaxis on the incidence of VTE in the post-op population.", - "NCTID": "NCT02334007" - }, - { - "brief_title": "Fondaparinux as Monotherapy for DVT and/or Pulmonary Embolism", - "phase": "", - "drugs": "['Fondaparinux']", - "drugs_list": [ - "Fondaparinux" - ], - "diseases": "['Deep Vein Thrombosis', 'Pulmonary Embolism']", - "diseases_list": [ - "Deep Vein Thrombosis", - "Pulmonary Embolism" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Recurrent venous thromboembolism despite anticoagulation with warfarin(Or) \n\n Clinically important bleeding complications due to warfarin(Or) \n\n Inability to achieve the target INR on warfarin(Or) \n\n Nonbleeding side effects of warfarin, such as hair loss, rash, purple toe syndrome(Or) \n\n Patient with cancer on monotherapy with parenteral anticoagulation for DVT and/ or PE \n\n and \n\n Require at least 90 days of anticoagulation \n\n Require anticoagulation for objectively confirmed DVT and/or PE \n\n Age greater than 18 years \n\n Written informed consent \n\n ", - "exclusion_criteria": ": \n\n Patients with renal insufficiency, defined as creatinine > 1.5 mg/dl \n\n Patients in whom anticoagulation with any agent is deemed unsafe due to bleeding risk. \n\n Pregnancy \n\n Known hypersensitivity to fondaparinux", - "brief_summary": "To determine whether fondaparinux as monotherapy without warfarin is effective and safe for long-term (90 days) treatment of DVT and/or PE, thus gaining new long-term experience and data using fondaparinux.", - "NCTID": "NCT00413504" - }, - { - "brief_title": "Extended Out-of-hospital Low-molecular-weight Heparin Prophylaxis Against DVT and PE in Patients Undergoing Major Lung Resection", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Venous Thrombosis', 'Pulmonary Embolism', 'Lung Neoplasms']", - "diseases_list": [ - "Venous Thrombosis", - "Pulmonary Embolism", - "Lung Neoplasms" - ], - "enrollment": "150.0", - "inclusion_criteria": "Patient inclusion criteria \n\n At least 18 years of age \n\n Either gender \n\n Diagnosed with resectable lung cancer or metastatic lung disease eligible to complete metastasectomy \n\n Undergoing one of the following surgeries: Segmentectomy, wedge resection, lobectomy, bilobectomy or pneumonectomy \n\n Competent to understand and sign consent documents \n\n Patient ", - "exclusion_criteria": " \n\n Known allergic or anaphylactic reaction to contrast dye, heparin or low molecular weight heparin (LMWH) \n\n Under current anticoagulation for venous thromboembolism or other medical conditions \n\n Known renal impairment, defined as creatinine clearance value of less than 55ml/min/m2 as calculated by the Cockroft-Gault method \n\n History of, or ongoing liver disease, manifested as ascites or previous peritoneal tapping for ascites \n\n Pregnant or planning to become pregnant \n\n Diagnosed or treated for VTE in the past 3 months prior to surgery \n\n Present or previous increase risk of haemorrhage \n\n History of previous HIT (heparin induced thrombocytopenia) \n\n Platelet count must be below 75,000 \n\n Previously inserted Inferior Vena Cava Filter (IVC) filter.", - "brief_summary": "Postoperative venous thromboembolism (VTE) is a significant health-care problem, resulting in significant morbidity, mortality and resource utilization. The true incidence is unknown, and may range from 1% to 15%. At the current time, the clinical practice of VTE prophylaxis in thoracic surgery includes administration of unfractionated or low molecular weight heparin starting at the perioperative period and finishing at the time of patients' discharge. In orthopaedic surgery, prolonged thromboprophylaxis beyond 10 days and up to 35 days has become the standard of care. There is a clear need to systematically evaluate the incidence of VTE after resection of lung malignancies and to evaluate the role of extended VTE prophylaxis in preventing Deep Vein Thrombosis (DVT) and pulmonary embolus (PE) after those major lung resections. This study will involve patients undergoing lung resection for malignancy at St. Joseph's Healthcare Hamilton and the University Health Network's Toronto General Hospital. The study will include 150 consecutively recruited patients. Study interventions will include Computed Tomography with pulmonary embolus (PE) protocol and bilateral extended leg Doppler Ultrasound for the detection of Deep Vein Thrombosis 30 days post-surgery.~In summary, this study is aimed at evaluating, for the first time in a prospective manner, the actual incidence of DVT and PE in patients undergoing major lung resections for malignancies. The knowledge gained in this study will be used to inform a future investigation involving a Randomized Controlled Trial (RCT) to compare current post-operative thromboprophylaxis with an extended 30-day prophylaxis protocol with the hope of providing an evidence-based practice change in VTE prophylaxis care for this high risk population.", - "NCTID": "NCT02258958" - }, - { - "brief_title": "NT-proBNP as a Tool for the Detection of Acute Pulmonary Artery Embolism (APE)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pulmonary Embolism', 'Pulmonary Embolism Without Mention of Acute Cor Pulmonale']", - "diseases_list": [ - "Pulmonary Embolism", - "Pulmonary Embolism Without Mention of Acute Cor Pulmonale" - ], - "enrollment": "44.0", - "inclusion_criteria": "inclusion criteria: \n\n all patients referred to the ICU with suspected APE \n\n ", - "exclusion_criteria": ": \n\n none", - "brief_summary": "In patients with suspected APE (Acute Pulmonary Embolism) referred to the intensive care unit (ICU)after major surgery, serum NT-proBNP (N-terminal proBNP), Troponin-I and D-dimers were measured according to the standard hospital protocol. To definitively confirm or exclude APE, all patients underwent an angiographic CT-scan of the thorax.", - "NCTID": "NCT01633671" - }, - { - "brief_title": "Anticoagulation Length in Cancer Associated Thrombosis", - "phase": "Phase 2", - "drugs": "['Low Molecular Weight Heparin (LMWH)']", - "drugs_list": [ - "Low Molecular Weight Heparin (LMWH)" - ], - "diseases": "['Cancer', 'Thrombosis', 'Venous Thromboembolism', 'Deep Vein Thrombosis', 'Pulmonary Embolus']", - "diseases_list": [ - "Cancer", - "Thrombosis", - "Venous Thromboembolism", - "Deep Vein Thrombosis", - "Pulmonary Embolus" - ], - "enrollment": "2.0", - "inclusion_criteria": "inclusion criteria: \n\n Receiving LMWH for treatment of CAT for five months \n\n Locally advanced or metastatic cancer \n\n Able to self-administer LMWH, or have LMWH administered by a carer \n\n Able to give informed consent \n\n Age \u226516 years \n\n ", - "exclusion_criteria": ": \n\n Receiving drug other than LMWH for CAT \n\n Contraindication to anticoagulation \n\n Fitted with a prosthetic heart valve \n\n Pregnant and/or lactating females", - "brief_summary": "This is a two year, multicentre, mixed methods feasibility study including a randomised controlled two-arm interventional trial, a nested qualitative study, focus groups and a United Kingdom (UK) wide survey exercise.", - "NCTID": "NCT01817257" - }, - { - "brief_title": "Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)", - "phase": "", - "drugs": "['ActiveCare CECT device', 'Enoxaparin']", - "drugs_list": [ - "ActiveCare CECT device", - "Enoxaparin" - ], - "diseases": "['Bleeding', 'Deep Vein Thrombosis of Lower Limb', 'Pulmonary Embolism (PE)']", - "diseases_list": [ - "Bleeding", - "Deep Vein Thrombosis of Lower Limb", - "Pulmonary Embolism (PE)" - ], - "enrollment": "411.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult patient (Age >18). Patient intended to undergo elective primary unilateral THA surgery. Patient is able and willing to follow instructions of care after surgery. Patient is able and willing to sign the institution human subjects committee approved Informed Consent Form. \n\n ", - "exclusion_criteria": ": \n\n Patient who has a known coagulation disorder. Patient currently treated with anticoagulant medications. Patient with known thrombophilia Patient with current signs and symptoms of or history of DVT/PE. Patient who is uncooperative or unable to follow instructions. Patient currently suffering from a solid tumor malignancy. Patient with active peptic disease. Patient with known allergy to baby aspirin (81 mg) or enoxaparin. Patient with contraindication to use of the device including patients with leg gangrene, recent skin graft or medical situations where increase venous and lymphatic return is undesirable.Patient has major surgery procedure within 3 months prior to the study surgery, or patients with a major surgery procedure planning during the study period.Pregnant women.Patient who is participating in another clinical drug trial.", - "brief_summary": "Evaluation of the safety and effectiveness of ActiveCare+ CECT device +/- baby dose aspirin (81 mg QD) for lowering the potential risk for bleeding and of DVT during and after THA surgery in comparison with LMWH.", - "NCTID": "NCT00358735" - }, - { - "brief_title": "The D-KAF (Dalteparin in Knee-to-Ankle Fracture) Trial", - "phase": "Phase 4", - "drugs": "['Low Molecular Weight Heparin (dalteparin)']", - "drugs_list": [ - "Low Molecular Weight Heparin (dalteparin)" - ], - "diseases": "['Deep Vein Thrombosis', 'Pulmonary Embolism']", - "diseases_list": [ - "Deep Vein Thrombosis", - "Pulmonary Embolism" - ], - "enrollment": "700.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 16 years \n\n Unilateral or bilateral, closed or open, fractures of the lower extremity distal to the knee including: \n\n Isolated fractures of the tibia including tibial plateau, shaft and plafond and medial malleolus \n\n Isolated fractures of the fibula including fibular head, fibular diaphysis,distal fibula and lateral malleolus \n\n Combined fractures of the tibia and fibula \n\n Tibia and/or fibula fractures may be accompanied by fractures of the patella and/or foot as well as ligamentous injuries as long as either the tibia or the fibula is involved \n\n Patients must be scheduled to undergo surgery (internal or external fixation) for repair of their fracture during the current admission \n\n ", - "exclusion_criteria": ": \n\n Patients presenting greater than 72 hours after injury \n\n Major injury involving other site(s) \n\n Lower extremity vascular injury requiring surgical repair \n\n Known systemic bleeding disorder or INR > 1.5, aPTT > 40 sec, or platelets < 50 x 109/L at baseline \n\n Active, uncontrolled bleeding (as determined by the attending surgeon or delegate) \n\n Intracranial or other major bleed in the previous 4 weeks \n\n Ongoing need for anticoagulation for other reasons \n\n Previous DVT or PE (objectively proven or treated with anticoagulants) \n\n Known molecular hypercoagulable state \n\n Active cancer \n\n Inability to receive contrast dye because of pregnancy, contrast allergy, or renal failure (serum creatinine > 300 mmol/L) \n\n Hypersensitivity to heparin or LMWH (including history of HIT) \n\n Inability to arrange out-of-hospital study medication administration \n\n Anticipated inability to undergo endpoint duplex ultrasound or follow-up (day 14 \u00b1 2, 6 weeks, 3 months) \n\n Inability or refusal to provide informed consent\u00b7 Previous participation in this study \n\n Estimated weight less than 40 kg", - "brief_summary": "It is known that patients who fracture their legs sometimes develop blood clots (known as deep vein thrombosis) in their legs. These clots may cause pain and swelling in the leg or they may detach and travel to the lungs producing shortness of breath, chest pain, and sometimes death. Unfortunately, it is not known how frequently these complications occur after leg fractures, or if the use of a blood thinner medication can effectively and safely prevent these clots. Doctors at hospitals across Canada are conducting a study in which patients who have surgery for leg fractures receive either a once-daily injection of a blood thinner, known as low molecular weight heparin, or a placebo injection for up to 14 days after their fractures. Neither the patients nor the doctors know which patient is on the medication and which patient is on placebo. All patients receive an ultrasound examination of their legs at 2 weeks after surgery to monitor for deep vein thrombosis. In addition, all patients are checked for symptoms of leg or lung clots and any side effects of the medication for 3 months. If the blood thinner is shown to be effective at reducing this complication and documented to be safe and cost-effective in this setting it will be recommended for use in such patients. If, on the other hand, the frequency of deep vein thrombosis is too low to justify the cost or inconvenience of taking this medication, this will also be an important finding.", - "NCTID": "NCT00187408" - }, - { - "brief_title": "Efficacy and Safety of Low-molecular Weight Heparin for Thromboprophylaxis in Acutely Ill Medical Patients", - "phase": "Phase 3", - "drugs": "['Certoparin', 'Heparin']", - "drugs_list": [ - "Certoparin", - "Heparin" - ], - "diseases": "['Embolism']", - "diseases_list": [ - "Embolism" - ], - "enrollment": "342.0", - "inclusion_criteria": "inclusion criteria: \n\n Hospitalization due to an acute non-surgical disease \n\n Significant decrease in mobility \n\n ", - "exclusion_criteria": ": \n\n Indication for anticoagulant or thrombolytic therapy \n\n Major surgical or invasive procedure within the 4 weeks that precede randomization \n\n Expected major surgical or invasive procedure (including spinal/peridural/epidural anesthesia or lumbar puncture) within the 2 weeks that follow the randomization \n\n Immobilization due to cast or fracture of lower extremity \n\n Immobilization lasting longer than 3 days in the period prior to randomization \n\n Heparin administration longer than 36 hours in the period prior to randomization \n\n Acute ischemic stroke \n\n Other protocol-defined inclusion/", - "brief_summary": "Acutely ill immobilized patients are at a high risk for thromboembolic events including deep venous thrombosis or pulmonary embolism. Unfractionated heparin (UFH) and low molecular weight heparins (LMWH) are thought to be effective in preventing thromboembolic events. This study is designed to provide efficacy and safety data for thromboprophylaxis with the LMWH certoparin in comparison to thromboprophylaxis with UFH in acutely ill non-surgical patients.", - "NCTID": "NCT00311753" - }, - { - "brief_title": "DULCIS (D-dimer and ULtrasonography in Combination Italian Study)", - "phase": "", - "drugs": "['D-dimer']", - "drugs_list": [ - "D-dimer" - ], - "diseases": "['Venous Thromboembolism']", - "diseases_list": [ - "Venous Thromboembolism" - ], - "enrollment": "1100.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 18 years first episode of objectively documented symptomatic idiopathic VTE, either proximal lower extremity deep vein thrombosis (DVT) and/or pulmonary embolism (PE). \n\n Unprovoked or idiopathic , or associated with one or more of the following favouring factors \n\n \u00b7 - minor general surgery, arthroscopy or laparoscopy \n\n pregnancy or puerperium \n\n hormonal treatment (contraceptive or replacement therapy) \n\n travel \n\n minor traumas \n\n hospitalization in a medical ward \n\n reduced mobility (non complete immobilization) at least six months of VKA therapy ( or other type) for at least 3 months and not longer than 12 months ability to provide informed consent \n\n ", - "exclusion_criteria": ": \n\n Two or more episodes of objectively documented proximal DVT and or PE ( previous distal of superficial vein thrombosis are not ", - "brief_summary": "The purpose of this study is to evaluate the efficacy and safety of a standardized procedure to establish the optimal duration of anticoagulation in patients with venous thromboembolism.", - "NCTID": "NCT00954395" - }, - { - "brief_title": "An Observational Post-Authorization Safety Specialist Cohort Event Monitoring Study (SCEM) to Monitor the Safety and Utilization of Rivaroxaban (Xarelto\u00ae).", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Atrial Fibrillation', 'Deep Vein Thrombosis', 'Pulmonary Embolism']", - "diseases_list": [ - "Atrial Fibrillation", - "Deep Vein Thrombosis", - "Pulmonary Embolism" - ], - "enrollment": "3400.0", - "inclusion_criteria": "inclusion criteria: \n\n age 18 years or above after study start \n\n index date on or after study start \n\n signed, informed consent \n\n patients treated for DVT or PE \n\n patients with non-valvular AF (with one or more risk factors) treated for prevention of stroke and systemic embolism \n\n ", - "exclusion_criteria": ": \n\n any use of univalent direct thrombin inhibitor or direct factor Xa inhibitors \n\n use of anticoagulant therapy or other vitamin K antagonists recorded within one year prior to index date", - "brief_summary": "This study aims to evaluate the use of rivaroxaban and its short term safety when used by patients for the new indications of prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE. Any adult patient started by their care team on rivaroxaban or an alternative anticoagulant for the specified indications during the study period will be eligible to take part. A questionnaire will be completed by the care team of each patient at the start of treatment and again 12 weeks later. The care team will complete the questionnaires using information from the patient's medical notes, not by asking the patient directly. If a participant has an adverse event during the 12 week period, we may ask the patient's care team to fill out a further follow up questionnaire. No other examinations or tests will be performed. Patients will only be recruited to the study after the clinical decision to prescribe rivaroxaban or an alternative anticoagulant has been made, so that prescribing behaviour is not altered by the study. It is an observational, non-interventional study covering the whole of England and Wales.", - "NCTID": "NCT01871194" - }, - { - "brief_title": "Prediction and Characterization of Acute and Chronic Postoperative Pain", - "phase": "", - "drugs": "['Conditioned pain modulation']", - "drugs_list": [ - "Conditioned pain modulation" - ], - "diseases": "['Pain', 'Pain, Postoperative', 'Funnel Chest']", - "diseases_list": [ - "Pain", - "Pain", - "Postoperative", - "Funnel Chest" - ], - "enrollment": "52.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients undergoing minimally invasive repair of pectus excavatum \n\n Age > 15 years old \n\n ", - "exclusion_criteria": ": \n\n Previous thoracic surgery interventions \n\n Disorders affecting the central or peripheral nervous system \n\n Chronic pain (pain intensity assessed by numerical rating scale > 3) \n\n Inability to speak and understand Danish (instructions, questionnaires) \n\n Inability to understand and participate in experimental pain modulation \n\n Psychiatric disorders (ICD-10) \n\n A history of frostbite in the non-dominant upper limb \n\n Sores or cuts on non-dominant upper limb \n\n Cardiovascular disease \n\n A history of fainting and/or seizures \n\n Fracture in non-dominant upper limb \n\n Reynaud's phenomenon", - "brief_summary": "Despite enormous progress insufficient postoperative pain management remains a frequent problem in the early postoperative phase after surgery. Furthermore, the pain that persists after healing of the surgical wound is a large, but often unrecognized, clinical problem and it is estimated that 5-10% of those undergoing surgery will develop severe persistent pain leading to chronic disability and psychosocial distress.~Conditioned Pain Modulation (CPM), also known as the phenomenon pain-inhibits-pain, is a reduction in pain somewhere on the body in response to the application of a second painful stimulus outside the painful area. In recent years, the CPM has been identified as a psycho-physical measure with clinical relevance in characterizing the individual's ability to modulate pain and consequently the individual's disposition to acquire painful conditions.~The purpose of this study is primarily to assess the relationship between CPM efficacy and clinical postoperative pain (postoperative pain intensity, use of analgesics, the intensity of secondary hyperalgesia and allodynia, and the incidence of persistent postoperative pain) associated with minimally invasive repair of pectus excavatum. In addition, the study aims at identifying other patient- and/or surgery-related factors affecting the course of postoperative pain.~Hypothesis:~- The greater the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a second painful stimulus (Cold Pressor Test), the lower the risk of developing persistent postoperative pain.~Secondary hypotheses~The greater the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a different experimental painful stimulus (Cold Pressor Test) lower the pain intensity in the early postoperative period.~The greater the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a different experimental painful stimulus (Cold Pressor Test), the shorter duration of early postoperative pain.~The greater the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a different experimental painful stimulus (Cold Pressor Test), the lower the usage of epidural analgesia (mg / ml).~The larger the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a different experimental painful stimulus (Cold Pressor Test) the lower consumption of oral analgesics (mg / day).~Severe acute pain in the early postoperative period (postoperative days 0-3) is positively associated with the development of persistent postoperative pain (6 months postoperatively).~Presence of preoperative pain and / or high postoperative use of analgesics and / or high pain intensity during the first 6-8 weeks postoperatively predicts pain 6 months postoperatively.~The higher pain intensity and discomfort associated with brush-evoked allodynia and / or pinprick (Von Frey) secondary hyperalgesia the greater the risk for developing persistent postoperative pain (6 months postoperatively).~High levels of preoperative catastrophizing (assessed on the day of admission) is related to the severity of acute pain (rated third postoperative day) and chronic pain (assessed 6 months postoperatively), even if controlled for depression and anxiety.~The degree of preoperative positive and negative emotions (as assessed on the day of admission) is related to the degree of acute pain (rated third postoperative day) and chronic pain (assessed 6 months postoperatively) so that negative emotions are associated with high levels of pain, while positive feelings are related to low levels of pain.~The study population does not differ significantly from the normal population in terms of personality traits (emotional reactions, extraversion, openness to experience, friendliness, conscientiousness).~The study population does not experience a significant change in personality traits during the first 6 months after surgery.~The quality of life and self-esteem is lower among patients who develop persistent postoperative pain compared with pain patients.~Quality of life and self-esteem improve as a result of minimally invasive repair of pectus excavatum.", - "NCTID": "NCT01308385" - }, - { - "brief_title": "Prediction of Acute Postoperative Pain and Analgesic Consumption", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Postoperative Pain']", - "diseases_list": [ - "Postoperative Pain" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Elective minimally invasive surgical correction of funnel chest (pectus excavatum \n\n age \u226515 years. \n\n ", - "exclusion_criteria": ": \n\n Previous thoracic surgical interventions \n\n Presence of diseases affecting the central and/or peripheral nervous system \n\n Presence of chronic pain conditions \n\n Inability to speak and/or understand Danish \n\n Inability to understand and participate in the experimental pain session \n\n Presence of psychiatric disorders \n\n History of frostbite in the non-dominant upper limb \n\n Presence of sores or cuts on non-dominant upper limb \n\n Presence of cardiovascular disease \n\n History of fainting and/or seizures \n\n Presence of fractures of the non-dominant upper limb \n\n Presence of Reynaud's phenomenon. \n\n Secondary exclusions included: \n\n Insensitivity to experimental cold pressor pain \n\n Lack of epidural catheter placement \n\n Re-operation", - "brief_summary": "Pain is an expected part of surgical recovery but effective pain management remains challenging. The high variability in postoperative pain experience and analgesic treatment response between patients is part of the challenge. Few studies have yet combined preoperative assessment of responses to experimental pain with measurements of cognitive and emotional processes in the prediction of postoperative pain.~We hypothesize, that preoperative evoked brain potentials (using standard electroencephalographic brain imaging), endogenous pain inhibition capacity (conditioned pain modulation), responses to pressure/thermal pain stimulation, and/or situational pain-related catastrophic thinking are useful clinical predictors of postoperative pain and analgesic consumption.", - "NCTID": "NCT02230865" - }, - { - "brief_title": "The STOP CLOT Pilot Study: Study of Low Molecular Weight Heparin in High Risk Cesarean Section", - "phase": "Phase 2; Phase 3", - "drugs": "['Tinzaparin']", - "drugs_list": [ - "Tinzaparin" - ], - "diseases": "['Deep Vein Thrombosis']", - "diseases_list": [ - "Deep Vein Thrombosis" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria (must meet inclusion criteria 1, 2 and 3): \n\n At high risk for thromboembolism (any one of the following): \n\n Age > 35 years \n\n Obesity (> 80 kg) \n\n Para 4 \n\n Gross varicose veins \n\n Current infection \n\n Pre-eclampsia \n\n Immobility prior to surgery (> 4 days) \n\n Major current disease: includes heart or lung disease, cancer, inflammatory bowel disease, and nephrotic syndrome. \n\n Emergency cesarean section in labour \n\n Extended major pelvic or abdominal surgery (e.g. cesarean hysterectomy) \n\n Patients with a family history of VTE \n\n History of superficial phlebitis \n\n Delivered by cesarean section (emergency or planned) \n\n Signed, informed consent \n\n ", - "exclusion_criteria": " (must not meet any of the following criteria): \n\n Greater than 36 hours since delivery \n\n Need for anticoagulation, including: \n\n Women with a confirmed thrombophilia \n\n Women with paralysis of lower limbs \n\n Women with personal history of VTE \n\n Women with antiphospholipid antibody syndrome (APLA) \n\n Women with mechanical heart valves \n\n Contraindication to heparin therapy, including: \n\n History of heparin induced thrombocytopenia \n\n Platelet count of less than 100,000 x 10^6/L \n\n Hemoglobin <= 90 g/L or a greater than 30 g/L drop in hemoglobin compared to last antepartum result \n\n History of osteoporosis \n\n History of steroid use (one week or more) \n\n Active bleeding \n\n Documented peptic ulcer within 6 weeks \n\n Heparin, bisulfite, or fish allergy \n\n Severe hypertension (systolic blood pressure [SBP] > 200 and/or diastolic blood pressure [DBP] > 120) \n\n Severe hepatic failure (International Normalized Ratio [INR] > 1.8) \n\n Women with serum creatinine > 80 and an abnormal 24 hour creatinine clearance. \n\n Contraindications to magnetic resonance imaging (MRI), including: \n\n Women with electrically, magnetically or mechanically activated implants \n\n Women with claustrophobia \n\n Women < 18 years of age", - "brief_summary": "Venous thromboembolism (VTE) remains the most common cause of maternal death in the developed world. VTE includes two conditions, deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT refers to a blood clot that has formed in a deep vein, often in the legs and/or pelvis and PE refers to the passage of these clots into the lungs (which can be fatal). VTE is up to 10 times more common in pregnant women than non-pregnant women of comparable age. More than a third of pregnancy related VTE occur during the 6 weeks after delivery. When compared with vaginal delivery, cesarean delivery further increases the risk of pregnancy associated VTE by three-fold.~A medication called low molecular weight heparin is sometimes prescribed during pregnancy and after delivery to prevent VTE. However, clinical practice varies because there hasn't been adequate research to determine that this medication is safe and effective at preventing VTE during this time. The potential benefits of the medication must also be weighed against its cost and possible side effects.~The researchers are conducting a study that will assess the effectiveness and safety of low molecular weight heparin in women who are at moderate to high risk of VTE after a cesarean section. They will monitor these women to determine if those who received the medication have fewer blood clots. Participants will also be monitored closely for any side effects.", - "NCTID": "NCT00225108" - }, - { - "brief_title": "Treatment Study Comparing Manual Treatment or Advice in Acute, Musculoskeletal Chest Pain", - "phase": "", - "drugs": "['chiropractic treatment', 'Self-management']", - "drugs_list": [ - "chiropractic treatment", - "Self-management" - ], - "diseases": "['Musculoskeletal Chest Pain', 'Non-cardiac Chest Pain', 'Undiagnosed Chest Pain']", - "diseases_list": [ - "Musculoskeletal Chest Pain", - "Non-cardiac Chest Pain", - "Undiagnosed Chest Pain" - ], - "enrollment": "115.0", - "inclusion_criteria": "inclusion criteria: \n\n To be included in the project the participant must \n\n Have chest pain as their primary complaint. \n\n Have an acute episode of pain of less than 7 days duration before admission. \n\n Consent to the standardized evaluation program at the chest pain clinic. \n\n Have pain the in the thorax and/or neck. \n\n Be able to read and understand Danish. Be between 18 and 75 year of age. \n\n Be a resident of the Funen County. \n\n Patients will not be included if any of the following conditions are present \n\n ACS. \n\n Have had Percutaneous Coronary Intervention (PCI) or Coronary Artery By-pass Grafting (CABG). \n\n Have a condition that is likely to results in the episode of chest pain. The condition must be verified clinically during admission (i.e. pulmonary embolism, pneumonia, dissection of the aorta, \u2026). \n\n Inflammatory joint disease. \n\n Insulin dependent diabetes. \n\n Fibromyalgia. \n\n Malignant disease. \n\n Apoplexy, dementia, or unable to cooperate. \n\n Major osseous anomaly. \n\n Osteoporosis. \n\n Pregnancy. \n\n Does not want to participate. \n\n Other - the reason for non-inclusion will be registered. \n\n ", - "exclusion_criteria": ": \n\n Participants will be excluded following baseline evaluation if any of the following conditions are present \n\n Pain not related to the joints and muscles of the neck and/or thorax (CTA negative, see below). \n\n New incidence of any of the above mentioned conditions/pathologies.", - "brief_summary": "Acute chest pain is a common cause of hospital admission. Active approaches are directed towards diagnosis and treatment of potentially life threatening conditions, especially acute coronary syndrome and coronary artery disease. However, a considerable number of patients may have chest pain caused by biomechanical dysfunction of muscles and joints of the chest wall or the cervical and thoracic spine (20%). The diagnostic approaches and treatment options for this group of patients are scarce and there is a lack of formal clinical studies and validated outcome measures addressing the effect of manual treatment approaches.~Objective: This single blind randomized clinical trial investigates whether chiropractic treatment can reduce pain and improve function in a population of patients with acute, musculoskeletal chest pain when compared to advice directed towards promoting self-management.~Methods: Among patients admitted to a chest pain clinic in a university hospital under suspicion of acute coronary syndrome, 120 patients with an episode of acute chest pain of musculoskeletal origin are included in the study. All patients have completed the chest pain clinic diagnostic procedures, and acute coronary syndrome and other obvious reasons for chest pain have been excluded. After completion of the study evaluation program, the patients are randomized into one of two groups: A) advice promoting self-management and individual instructions focusing on posture and muscle stretch; B) a course of chiropractic therapy of up to ten treatment sessions focusing on high velocity, low amplitude manipulation of the cervical and thoracic spine together with a choice of mobilisation and soft tissue techniques. In order to establish suitable outcome measures, two pilot studies were conducted. Outcome measures are pain, function, overall health, and patient-rated treatment effect measured at 4, 12, and 52 weeks following treatment.", - "NCTID": "NCT00462241" - }, - { - "brief_title": "Improving Venous Thromboembolism Prophylaxis", - "phase": "Phase 4", - "drugs": "['VTE-P Tollgate', 'BLAZE Pop up', 'Usual Care']", - "drugs_list": [ - "VTE-P Tollgate", - "BLAZE Pop up", - "Usual Care" - ], - "diseases": "['Venous Thromboembolism', 'Delivery of Health Care', 'Quality Improvement']", - "diseases_list": [ - "Venous Thromboembolism", - "Delivery of Health Care", - "Quality Improvement" - ], - "enrollment": "3000.0", - "inclusion_criteria": "inclusion criteria: \n\n Inpatients with age > 17 years old \n\n ", - "exclusion_criteria": ": \n\n Outpatients \n\n Inpatients with age less than or equal to 17 years old", - "brief_summary": "Preventing the formation of blood clots in the veins so they do not injure leg veins or travel to the lungs, also called venous thromboembolism prophylaxis (VTE-P) is an essential component of safe in-patient care, yet it is deployed sub-optimally in many hospitals, including The investigators own. Two prior VTE-P improvement projects were completed at Mayo Clinic hospitals, one in the Department of Medicine, and the other in selected divisions of the Department of Surgery. Both projects resulted in marked improvement in the percentage of patients receiving appropriate VTE-P. This project seeks to utilize the lessons learned from these two pilots along with known best practices for "spreading" to deploy methods that enhance VTE-P to the entire hospitalized population. The investigators seek appropriate VTE-P rates exceeding 95%.", - "NCTID": "NCT01304108" - }, - { - "brief_title": "Dyspnea and Biomarkers in a Prehospital Setting", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Dyspnea', 'Heart Failure', 'Asthma', 'COPD']", - "diseases_list": [ - "Dyspnea", - "Heart Failure", - "Asthma", - "COPD" - ], - "enrollment": "546.0", - "inclusion_criteria": "inclusion criteria: \n\n patient had to present with shortness of breath as the primary complaint (defined as either the sudden onset of dyspnea without history of chronic dyspnea or an increase in the severity of chronic dyspnea) \n\n ", - "exclusion_criteria": ": \n\n age <18 years \n\n history of renal insufficiency, trauma, severe coronary ischemia (unless patient's predominant presentation was dyspnea), and other causes of dyspnea: \n\n pneumonia \n\n pulmonary embolism \n\n carcinoma \n\n pneumothorax \n\n pleural effusion \n\n intoxications (drugs) \n\n anaphylactic reactions \n\n upper airway obstruction \n\n bronchial stenosis \n\n gastroesophageal reflux disorder \n\n according to the history, clinical status, and additional laboratory tests available in pre-hospital setting (D-dimer, troponin, C-reactive protein)", - "brief_summary": "In patients presenting with acute dyspnea in a pre-hospital setting, the early and correct diagnosis may present a significant clinical challenge. Physical examination, chest radiography, electrocardiography, and standard biological tests often fail to accurately differentiate heart failure (HF) from pulmonary causes of dyspnea. Timely differentiation of HF from other causes of dyspnea may permit the early institution of appropriate medical therapy. Brain natriuretic peptide (BNP) and amino-terminal pro-brain natriuretic peptide (NT-proBNP) have been proposed as early markers of HF and demonstrated to be useful for diagnosing and excluding HF in the emergency department. A combination of BNP or NT-proBNP testing and standard clinical assessment has been suggested to be superior to either tool used in isolation. Some previous studies have also suggested that quantitative capnometry (QC) may be useful in differentiating between cardiac and obstructive causes of respiratory distress. Therefore, the investigators hypothesized that a new combination of NT-proBNP testing, standard clinical assessment, and partial pressure of end-tidal CO2 (PetCO2) would optimize evaluation and differentiation of acute dyspnea in a pre-hospital setting.~The aim of this study was to determine the accuracy of combination of QC, NT-proBNP, and clinical assessment in differentiating acute HF from obstructive pulmonary disease (COPD/asthma) as a cause of acute dyspnea in pre-hospital emergency setting.", - "NCTID": "NCT00878475" - }, - { - "brief_title": "Randomized Controlled Trial of Anticoagulation vs. Placebo for a First Symptomatic Isolated Distal Deep-vein Thrombosis (IDDVT)", - "phase": "Phase 3", - "drugs": "['nadroparine calcium', 'Placebo']", - "drugs_list": [ - "nadroparine calcium", - "Placebo" - ], - "diseases": "['Distal (Calf) Deep-vein Thrombosis']", - "diseases_list": [ - "Distal (Calf) Deep-vein Thrombosis" - ], - "enrollment": "260.0", - "inclusion_criteria": "inclusion criteria: \n\n All outpatients with an acute, symptomatic, distal DVT will be included in the study, provided they correspond to the following diagnostic and ", - "exclusion_criteria": ", and they have signed an informed consent form. \n\n ", - "brief_summary": "CACTUS-PTS is a randomized, placebo-controlled, double-blind study which aims primarily to determine the effectiveness of a 6 week course of therapeutic-dose LMWH (nadroparine) injections vs. placebo in patients with a first symptomatic isolated distal (calf) deep-vein thrombosis (IDDVT), as measured by rate of proximal DVT and symptomatic PE at 6 weeks. Additionally, the study aims to determine if the 6 week course of treatment with therapeutic-dose LMWH (nadroparine) injections, compared to placebo, decreases the frequency of post-thrombotic syndrome (PTS) at 1 year.", - "NCTID": "NCT00421538" - }, - { - "brief_title": "Postoperative Analgesia After Total Hip Replacement", - "phase": "Phase 3", - "drugs": "['Intrathecal morphine at surgery, 0.1mg and placebo', 'Patient Controlled Analgesia with iv morphine and placebo', 'intrathecal morphine AND patient controlled analgesia with iv morphine']", - "drugs_list": [ - "Intrathecal morphine at surgery", - "0.1mg and placebo", - "Patient Controlled Analgesia with iv morphine and placebo", - "intrathecal morphine AND patient controlled analgesia with iv morphine" - ], - "diseases": "['Total Hip Replacement']", - "diseases_list": [ - "Total Hip Replacement" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients accepted for fast-track total hip replacement, i.e.ASA 3 or lower \n\n ", - "exclusion_criteria": ": \n\n Not able to speak dutch \n\n communication problems \n\n dementia \n\n mental retardation", - "brief_summary": "There are several treatments for postoperative pain after Hip Replacement Surgery. However, some require an intravenous line which may interfere with rehabilitation after surgery. This study aims to evaluate which method of pain treatment is best after Hip Replacement Surgery. Patients will either receive pain treatment at surgery, continuous intravenous pain treatment, or both. In the first two days after surgery, patients will frequently be asked to rate their pain, and use of other pain medication will be monitored.", - "NCTID": "NCT00219921" - }, - { - "brief_title": "Respiratory Therapy and Newborn Pain: Comparison Between Techniques", - "phase": "", - "drugs": "['Thoracoabdominal rebalancing', 'Physical Therapy']", - "drugs_list": [ - "Thoracoabdominal rebalancing", - "Physical Therapy" - ], - "diseases": "['Newborn Pain', 'Respiratory Therapy Techniques']", - "diseases_list": [ - "Newborn Pain", - "Respiratory Therapy Techniques" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Newborns up to 28 days with any weight and gestational age in ventilatory support or oxygen therapy and clinical indication for Physical Therapy. \n\n ", - "exclusion_criteria": ": \n\n Newborns with contraindication of respiratory therapy, those that had problems during any of the study procedures and changes in those suffering from respiratory support or oxygen therapy during data collection. \n\n If there was failure to collect any of the parameters for evaluating the newborn also was no longer part of the sample.", - "brief_summary": "This study intend to assess the pain intensity of newborns in neonatal intensive care unit (NICU) undergoing different techniques of respiratory therapy and compare these procedures. A randomized controlled clinical trial and blind trial with newborns admitted to NICU. The babies were categorized according to gestational age , age, weight, diagnosis, support and signs of respiratory distress. Then, they were allocated by lot to come from one of 3 groups: G1 - control, G2 - undergoing physical therapy; G3 - received the thoracoabdominal rebalancing. Each newborn received just one physical therapy session in that they were assessed before one of the three procedures (T1), immediately after (T2) and after 15 minutes (T3). This evaluation found cardiorespiratory parameters (oxygen saturation, heart and respiratory rate) and three specific scales for pain assessment (NIPS, NFCS and PIPP). The hypothesis is that newborns hospitalized in intensive care unit did not show pain when undergoing respiratory therapy.", - "NCTID": "NCT01240044" - }, - { - "brief_title": "Effect of Gabapentin on Orthopedic Pain", - "phase": "Phase 4", - "drugs": "['Placebo', 'Gapabentin']", - "drugs_list": [ - "Placebo", - "Gapabentin" - ], - "diseases": "['Degenerative Arthritis and Postoperative Pain']", - "diseases_list": [ - "Degenerative Arthritis and Postoperative Pain" - ], - "enrollment": "34.0", - "inclusion_criteria": "inclusion criteria: \n\n Undergoing a hip arthroplasty, total knee arthroplasty, hip fracture repair American Society of Anesthesiologist rating I-III as determined by your anesthesiologist \n\n ", - "exclusion_criteria": ": \n\n Pregnancy and breast feeding \n\n An allergy to any of the drugs to be used in the study (midazolam, Celecoxib, gabapentin, hydromorphone, bupivacaine) \n\n History of a sleep disorder (Obstructive sleep apnea or daytime somnolence) \n\n History of taking chronic narcotic pain medications or gabapentin \n\n History of rheumatoid arthritis, a psychiatric disorder, or diabetes with impaired renal function \n\n History of alcohol or illicit drug abuse. \n\n History of a kidney or liver problem. \n\n Inability or unwilling to use patient-controlled analgesia. \n\n Unable to meet the criteria for removal of the endotracheal tube in the Operating Room \n\n History of asthma, hives or an allergic type reaction following an aspirin or other NSAIDS drug such as Ibuprofen. \n\n History of stroke or heart attack or thrombotic event within the past 3 months \n\n Lactose intolerance \n\n History of cardiac surgery", - "brief_summary": "This study is being done to determine if a drug called gabapentin helps in the postoperative management of patients undergoing hip and knee operations. The investigators wish to determine the effect of gabapentin on pain and sleep following surgery. If we can lessen a patient's pain and improve sleep, the patient will be better able to participate in their physical therapy. Gabapentin has already been shown to lessen postoperative pain when given before surgery. In healthy patients, it has also been shown to improve certain aspects of sleep. We hope to identify the effect of the drug, when given after surgery, on patients' pain and sleep.", - "NCTID": "NCT01546857" - }, - { - "brief_title": "Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery", - "phase": "Phase 4", - "drugs": "['Ropivacaine', 'Placebo', 'An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively']", - "drugs_list": [ - "Ropivacaine", - "Placebo", - "An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively" - ], - "diseases": "['Pain, Postoperative', 'Anesthesia, Conduction', 'Arthroplasty, Replacement, Hip']", - "diseases_list": [ - "Pain", - "Postoperative", - "Anesthesia", - "Conduction", - "Arthroplasty", - "Replacement", - "Hip" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Primary total hip replacement \n\n ", - "exclusion_criteria": ": \n\n general anaesthesia \n\n Allergy to local anesthetics of the amide type \n\n Revision surgery \n\n Bilateral surgery \n\n Chronic pain patient \n\n Women in the fertile age", - "brief_summary": "The purpose of this study was to evaluate the analgesic efficacy of the nervus cutaneous femoral lateralis (NCFL) blockade on postoperative pain after total hip replacement surgery. The NCFL-block is a pure sensory block. We hypothesized that the NCFL-block would reduced the postoperative pain without delaying mobilization.", - "NCTID": "NCT02289937" - }, - { - "brief_title": "PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT Pilot)", - "phase": "Phase 3", - "drugs": "['Fragmin (Dalteparin) LMWH verus Unfractionated Heparin (UFH)']", - "drugs_list": [ - "Fragmin (Dalteparin) LMWH verus Unfractionated Heparin (UFH)" - ], - "diseases": "['Critically Ill', 'Deep Venous Thrombosis']", - "diseases_list": [ - "Critically Ill", - "Deep Venous Thrombosis" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Admission to ICU \n\n Men and women greater than 18 years of age or older \n\n Expected to remain in ICU admission greater than 72 hours \n\n ", - "exclusion_criteria": ": \n\n Contraindications to LMWH or blood products \n\n Trauma, post orthopedic surgery, post cardiac surgery or post neurosurgery patients, \n\n Uncontrolled hypertension as defined by a systolic blood pressure > 180 mmHg or a diastolic blood pressure > 110 mmHg, \n\n Hemorrhagic stroke, DVT, PE or major hemorrhage on admission or within 3 months, \n\n Coagulopathy as defined by INR >2 times upper limit of normal [ULN], or PTT >2 times ULN, \n\n Renal insufficiency as defined by a creatinine clearance <30ml/min, \n\n A need for oral or intravenous or subcutaneous therapeutic anticoagulation, \n\n Heparin allergy, proven or suspected heparin-induced thrombocytopenia (HIT), \n\n Receipt of >2 doses of UFH or LMWH in ICU, \n\n Pregnant or lactating, \n\n Withdrawal of life support or limitation of life support, \n\n Prior enrollment in this trial \n\n Prior enrollment into a related RCT \n\n Thrombocytopenia defined platelet count < 100 x 109/L, \n\n Bilateral lower limb amputation, \n\n Allergy to pork or pork products", - "brief_summary": "PROTECT Pilot objective is to assess: 1) the feasibility of timely enrollment and complete, blinded study drug administration, 2) the bioaccumulation of LMWH in patients with acquired renal insufficiency and its association with bleeding, 3) the feasibility of scheduled twice weekly lower limb ultrasounds, and 4) recruitment rates for a future randomized trial.", - "NCTID": "NCT00182364" - }, - { - "brief_title": "Sex Differences in Coronary Pathophysiology", - "phase": "", - "drugs": "['30 cc blood draw', 'Intravascular ultrasound (IVUS)', 'Coronary pressure/flow wire testing', 'Coronary pressure/flow testing: Acetycholine challenge', 'Procedure: Coronary pressure/flow testing: Nitroglycerin challenge', 'Procedure: Procedure: Coronary pressure/flow testing: Adenosine challenge']", - "drugs_list": [ - "30 cc blood draw", - "Intravascular ultrasound (IVUS)", - "Coronary pressure/flow wire testing", - "Coronary pressure/flow testing: Acetycholine challenge", - "Procedure: Coronary pressure/flow testing: Nitroglycerin challenge", - "Procedure: Procedure: Coronary pressure/flow testing: Adenosine challenge" - ], - "diseases": "['Chest Pain', 'Ischemia']", - "diseases_list": [ - "Chest Pain", - "Ischemia" - ], - "enrollment": "126.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient referred for elective coronary angiography because of a reasonable clinical suspicion of coronary ischemia. \n\n Presence of angina or an anginal equivalent (including chest, back, shoulder, arm, neck, jaw discomfort, or shortness of breath brought on by physical exertion, emotional stress, or certain times of day/month). \n\n ", - "exclusion_criteria": ":1) Asymptomatic (such as a pre-op cath) \n\n 2) Status-post heart transplant \n\n 3) Status-post coronary artery bypass grafting \n\n 4) Age <18 \n\n 5) Renal insufficiency (creatinine >1.5) \n\n 6) Presence of an acute coronary syndrome (STEMI or NSTEMI), Tako-tsubo, an abnormal ejection fraction (EF<55%), cardiogenic shock, or recent VT/VF \n\n 7) Presence of another likely explanation of chest pain, such as pulmonary hypertension or aortic stenosis \n\n 8) History of adverse reaction to any of the medications being used (acetylcholine, nitroglycerin, adenosine, or heparin) \n\n 9) Currently taking vasoactive medication (such as nitroglycerin) \n\n 10) Inability to provide an informed consent, including an inability to speak, read, or understand English, Spanish, Chinese, Farsi, Japanese, Korean, Russian, or Vietnamese \n\n 11) A hearing impairment that won't allow for a typical verbal conversation or a visual impairment that won't allow for reading of the written consent \n\n 12) Participation in another study (with the exception of the Stanford Gene-PAD study) \n\n 13) A potentially vulnerable subject (including minors, pregnant women, economically and educationally disadvantaged, decisionally impaired, and homeless people)", - "brief_summary": "This is a research study evaluating possible causes of chest pain (or an anginal equivalent, such as fatigue resulting in a decrease in exercise tolerance, shortness of breath, or back, shoulder, neck, or jaw pain) in people with no evidence of significant coronary artery disease on their coronary angiogram (pictures of the blood vessels in the heart). The purpose of the research study is to determine if there is diffuse atherosclerosis (plaque) not appreciated by angiography, or if the coronary endothelium (lining of the blood vessels in the heart) and/or microcirculation (small vessels in the heart that are not easily seen with an angiogram) are not functioning properly in those who have chest pain (or an anginal equivalent), but normal coronary arteries on angiography. Specifically, we are interested if these findings are more common in women than men.", - "NCTID": "NCT00823563" - }, - { - "brief_title": "The Analgesic Efficacy of Periarticular Infiltration of Local Anaesthetic for Total Hip Replacement", - "phase": "Phase 4", - "drugs": "['Levobupivacaine', 'Intrathecal morphine']", - "drugs_list": [ - "Levobupivacaine", - "Intrathecal morphine" - ], - "diseases": "['Total Hip Arthroplasty']", - "diseases_list": [ - "Total Hip Arthroplasty" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients scheduled for unilateral total hip replacement \n\n Consent to spinal anaesthesia \n\n ASA Grade I to III \n\n ", - "exclusion_criteria": ": \n\n Patient refusal \n\n Mini-Mental Score < 25 \n\n Allergy to bupivacaine, morphine, paracetamol, diclofenac \n\n Skin lesions/infection at site of injection \n\n Uncorrected renal dysfunction \n\n Coagulation disorders \n\n chronic pain condition other than hip pain", - "brief_summary": "Total hip replacement is a major surgical procedure usually associated with significant pain in the early postoperative period. In our hospital, total hip replacement is routinely performed under spinal anaesthesia with intrathecal bupivacaine local anaesthetic plus opioid in the form of preservative free morphine. The use of 'local infiltration analgesia' as an alternative postoperative analgesic technique has been investigated.In this technique the surgeon infiltrates the surgical site with a long-acting local anaesthetic and places a catheter under direct vision which remains in situ and is used to administer local anaesthetic in the postoperative period until such time as it is removed (when no longer deemed necessary for pain relief or at a pre-set time in the postoperative period e.g. 48 hours). We hypothesize that infiltration of the surgical site with peri- and intraarticular levobupivacaine local anaesthetic would be an efficacious pain management technique and would not be inferior to intrathecal morphine for postoperative pain management.", - "NCTID": "NCT01312077" - }, - { - "brief_title": "The Effect of Periarticular Multi-Drug Regimen on Pain After Partial Hip Replacement", - "phase": "Phase 4", - "drugs": "['periarticular injection of multidrug regimen', 'none of medication preoperatively and intraoperatively']", - "drugs_list": [ - "periarticular injection of multidrug regimen", - "none of medication preoperatively and intraoperatively" - ], - "diseases": "['Femoral Neck Fracture']", - "diseases_list": [ - "Femoral Neck Fracture" - ], - "enrollment": "258.0", - "inclusion_criteria": "inclusion criteria: \n\n femoral neck fracture \n\n partial hip replacement \n\n ", - "exclusion_criteria": ": \n\n r/o infection \n\n reoperation \n\n mental change", - "brief_summary": "This prospective randomized study aims to evaluate the effectiveness of periarticular multi-drug regimen injection on the relief of pain in patients undergoing partial hip replacement.~Total 258 patients will be randomized into one of two groups (groupC or groupI) based on Excel number generation.~Patients in group C will receive no medication intraoperatively, and patients in group I will receive oral oxycodone and celecoxib preoperatively and a periarticular injection of multi-drug regimen during operation.~Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 1, 4, 7 postoperative day.", - "NCTID": "NCT01112436" - }, - { - "brief_title": "Sensory Changes From Chest Drains", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Thoracotomy', 'Chronic Pain']", - "diseases_list": [ - "Thoracotomy", - "Chronic Pain" - ], - "enrollment": "21.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 18 \n\n Able to cooperate \n\n able to speak and read Danish \n\n ", - "exclusion_criteria": ": \n\n repeat surgery \n\n cognitive dysfunction \n\n other nerve injury on the thorax \n\n abuse (medicine/ alcohol etc)", - "brief_summary": "Does chest drains contribute to the post thoracotomy pain syndrome", - "NCTID": "NCT01274871" - }, - { - "brief_title": "Anatomical, Radiological and Biomechanical Examination of Athletic Groin Pain Patients and Physical Therapy Intervention", - "phase": "", - "drugs": "['Biomechanics led physical therapy rehabilitation']", - "drugs_list": [ - "Biomechanics led physical therapy rehabilitation" - ], - "diseases": "['Groin Pain']", - "diseases_list": [ - "Groin Pain" - ], - "enrollment": "600.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of athletic groin pain \n\n Professional athlete in full time training with groin pain diagnosis \n\n ", - "exclusion_criteria": ": \n\n Post infective osteitis \n\n Bone tumour \n\n Acute injury", - "brief_summary": "Athletic groin pain (AGP) is a chronic condition common in multi-directional sports (Walden et al. 2007, Robinson et al. 2004, Murphy et al. 2012). It is a complex injury with a challenging diagnosis. Dramatic differences in the anatomical diagnoses of AGP cohorts exist in the literature (Renstrom et al. 1980, Lovell et al. 1995, Holmich et al. 2007, Bradshaw et al. 2008). This may be due to the complexity of the anatomy in the region and the absence of magnetic resonance imaging (MAGNETIC RESONANCE IMAGE) to confirm clinical examination.~Dynamic actions undertaken in field sports (including change of direction cutting) are particularly associated with the development of athletic groin pain (Holmich et al. 2014). Dynamic multi-plane, multi-joint actions can overload musculoskeletal and fascial structures in the hip and groin. Despite this, traditional groin pain assessments do not involve an examination of sport specific actions. An examination of jumping, hopping and cutting mechanics, which is possible with the use of three dimensional motion capture techniques, will provide additional information with which to diagnosis and rehabilitate athletes.~While the majority of published studies on AGP have focused on surgical management (Serner et al. 2015), exercise therapy has been found to be an effective treatment (Holmich et al. 1995). In exercise therapy studies the best results were shown by Holmich et al (1995) where subjects suffered for an average of 9.9 months with symptoms and a strength and stability program focused on adductor strength returned them to sport in 18.5 weeks. The latest paper on rehabilitation by Jardi et al. demonstrates little improvement with a mean time to return to training of 86 days +/-15. The focus remains on improving strength of isolated muscle groups and not attempting to address underlying biomechanical abnormalities that may be leading to overload. Accurate biomechanical assessment and individualized rehabilitation based on the high speed multiplanar movements that drive the athlete's symptoms may enhance the efficiency of rehabilitation. Moreover post-rehabilitation changes in biomechanical factors may provide a further insight into the biomechanical factors associated with AGP.~The purpose of this study was to:~Describe clinical presentation (physical examination and magnetic resonance imaging findings) for a group of athletes presenting with AGP~To describe the different biomechanical diagnoses that exist in AGP patients~To examine the effects of a biomechanics led exercise intervention to rehabilitate chronic groin pain~It is hypothesised that standardised magnetic resonance imaging will aid in the anatomical diagnosis of athletic groin pain patients. From a biomechanics perspective, distinct subgroups/clusters will exist that differ from each other in how they undertake dynamic sport specific actions. These distinct clusters will describe potential biomechanical diagnoses that exist in groin pain patients. A biomechanics led rehabilitation program will return groin pain patients back to sport more quickly than previous rehabilitation programs without biomechanical diagnostic information.~Brief protocol Participants will be recruited from patients with chronic athletic groin pain who present for investigation and rehabilitation at Sports Surgery Clinic, Ireland. A standardised clinical examination will be undertaken including range of motion assessment, pain provocation and load tolerance tests, and palpation.~A Magnetic Resonance Image of the hip and groin region will then be undertaken and read by a consultant sports physician.~Biomechanical assessment will include capturing of jumping, hopping and cutting mechanics through the use of three dimensional motion capture technology and force plates. Here reflective markers are placed on the skin at anatomical landmarks. These markers are picked up by the cameras and tracked at 200 frames per second. Participants will contact the force plate with their foot on undertaking the movements. Force and marker data will be combined to calculate joint angles and moments.~Physical therapy assessment will include an assessment of functional movement, range of motion testing, adductor squeeze tests, strength assessment of hip and trunk. Physiotherapists will utilise three dimensional biomechanical data during cutting and landing to inform individualised rehabilitation. Rehabilitation will consist of movement control, whole body strength and power, linear running mechanics, multi-directional mechanics and conditioning sessions. Participants will have follow up physical therapy appointments approximately every two weeks. A hip and groin outcome score (HAGOS) will be used to monitor the morbidity and severity of the injury throughout the rehabilitation process.~Once the physiotherapist determines that the patient is ready to return to play a biomechanical re-test will be undertaken.", - "NCTID": "NCT02437942" - }, - { - "brief_title": "Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography", - "phase": "Phase 3", - "drugs": "['Cardiac Computed Tomography']", - "drugs_list": [ - "Cardiac Computed Tomography" - ], - "diseases": "['Acute Coronary Syndrome', 'Myocardial Infarction', 'Unstable Angina Pectoris']", - "diseases_list": [ - "Acute Coronary Syndrome", - "Myocardial Infarction", - "Unstable Angina Pectoris" - ], - "enrollment": "1000.0", - "inclusion_criteria": "inclusion criteria: \n\n Participant had at least five minutes of chest pain or equivalent (chest tightness; pain radiating to left, right, or both arms or shoulders, back, neck, epigastrium, jaw/throat; or unexplained shortness of breath, syncope/presyncope, generalized weakness, nausea, or vomiting thought to be of cardiac origin) at rest or during exercise within 24 hours of ED presentation, warranting further risk stratification, as determined by an ED attending. \n\n 2 or more cardiac risk factors (diabetes, hypertension, hyperlipidemia, current smoker and family history of coronary artery disease). \n\n Able to provide a written informed consent. \n\n <75 years of age, but >40 years of age. \n\n Able to hold breath for at least 10 seconds. \n\n Sinus rhythm. \n\n ", - "exclusion_criteria": ": \n\n New diagnostic ischemic ECG changes (ST-segment elevation or depression > 1 mm or T-wave inversion > 4 mm) in more than two anatomically adjacent leads or left bundle branch block \n\n Documented or self-reported history of CAD (MI, percutaneous coronary interventions [PCIs], coronary artery bypass graft [CABG], known significant coronary stenosis [>50%]) \n\n Greater than 6 hours since presentation to ED. \n\n BMI >40 kg/m2 \n\n Impaired renal function as defined by serum creatinine >1.5 mg/dL* \n\n Elevated troponin-T (> 0.09 ng/ml) \n\n Hemodynamically or clinically unstable condition (BP systolic < 80 mm Hg, atrial or ventricular arrhythmias, persistent chest pain despite adequate therapy) \n\n Known allergy to iodinated contrast agent \n\n Currently symptomatic asthma \n\n Documented or self-reported cocaine use within the past 48 hours (acute) \n\n On Metformin therapy and unable or unwilling to discontinue for 48 hours after the CT scan \n\n Contraindication to beta blockers (taking daily antiasthmatic medication): This exclusion only applies to patients with a heart rate >65 bpm at sites using a non-dual source CT scanner \n\n Participant with no telephone or cell phone numbers or no address (preventing follow-up) \n\n Participant with positive pregnancy test. Women of childbearing potential, defined as <2 years of menopause in the absence of hysterectomy or tube ligation, must have a pregnancy test performed within 24 hours before the CT scan. \n\n Participant unwilling to provide a written informed consent.", - "brief_summary": "The growing availability of cardiac computed tomography (CT)* in emergency departments (EDs) across the U.S. expands the opportunities for its clinical application, but also heightens the need to define its appropriate use in the evaluation of patients with acute chest pain. To address this need, we performed a randomized diagnostic trial (RDT) to determine whether integrating cardiac CT, along with the information it provides on coronary artery disease (CAD) and left ventricular (LV) function, can improve the efficiency of the management of these patients (i.e. shorten length of hospital stay, increase direct discharge rates from the ED, decreasing healthcare costs and improving cost effectiveness while being safe).", - "NCTID": "NCT01084239" - }, - { - "brief_title": "Usefulness of Chest Wall Tenderness as Bedside Test to Exclude Acute Coronary Syndrome in Different Demographic Groups", - "phase": "", - "drugs": "['Clinical examination: chest wall tenderness']", - "drugs_list": [ - "Clinical examination: chest wall tenderness" - ], - "diseases": "['Chest Pain']", - "diseases_list": [ - "Chest Pain" - ], - "enrollment": "110.0", - "inclusion_criteria": "inclusion criteria: All patients over the age of 18 years presenting with the leading symptom of first time or recurrent acute chest pain in the emergency room of the Department of Internal Medicine, University Hospital of Zurich. \n\n ", - "exclusion_criteria": ": \n\n Missing informed consent. \n\n Cardiopulmonary unstable patients. \n\n No self reported chest pain. \n\n Recent thoracic surgery within1 year, inflammatory joint disease, fibromyalgia, cardiogenic shock.", - "brief_summary": "To determine the significance of a simple bedside clinical test (chest wall tenderness) to exclude myocardial ischemia in different demographic groups.", - "NCTID": "NCT01724996" - }, - { - "brief_title": "Effect of Early Mechanical Ventilation to Severe Acute Pancreatitis", - "phase": "", - "drugs": "['early mechanical Ventilation', 'Conventional Mechanical Ventilation']", - "drugs_list": [ - "early mechanical Ventilation", - "Conventional Mechanical Ventilation" - ], - "diseases": "['Acute Pancreatitis', 'Complication of Ventilation Therapy']", - "diseases_list": [ - "Acute Pancreatitis", - "Complication of Ventilation Therapy" - ], - "enrollment": "2.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of pancreatitis:typical pain, increase in serum lipase or amylase, onset of abdominal pain within 72h before admission \n\n The diagnosis criteria of Severe Acute Pancreatitis is according to Atlanta criteria revisited in 2012 \n\n the diagnosis of ARDS meets the criteria of Berlin definition \n\n ", - "exclusion_criteria": ": \n\n chronic respiratory disease as chronic obstructive pulmonary disease (COPD), asthma \n\n organic cardiopathy \n\n pregnancy", - "brief_summary": "Acute lung injury (ALI) and acute respiratory distress syndrome(ARDS) represent the most common and earliest organ dysfunction in acute pancreatitis, presenting as dyspnea and intractable hypoxemia, with secondary bilateral pulmonary infiltrates on radiograph. And mechanical ventilation (MV) is the essential intervention to improve oxygenation. When to initiate MV remains uncertain. In this study, we aim to compare the effect of early MV and conventional MV, and we hypothesize that early MV may be a better treatment option.", - "NCTID": "NCT01992224" - }, - { - "brief_title": "A Comparison of Certoparin and Unfractionated Heparin in the Prevention of Thromboembolic Events in Acutely Ill Medical Patients", - "phase": "Phase 3", - "drugs": "['Certoparin', 'Unfractionated Heparin']", - "drugs_list": [ - "Certoparin", - "Unfractionated Heparin" - ], - "diseases": "['Thromboembolism']", - "diseases_list": [ - "Thromboembolism" - ], - "enrollment": "3254.0", - "inclusion_criteria": "inclusion criteria: \n\n Hospitalized medical patients 70 years of age or older \n\n Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances) \n\n written informed consent \n\n ", - "exclusion_criteria": ": \n\n immobilization longer than 3 days prior to randomization \n\n prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system \n\n expected major surgical or invasive procedure within the next 3 weeks after randomization \n\n LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization \n\n immobilization due to cast or fracture \n\n indication for anticoagulatory or thrombolytic therapy \n\n acute symptomatic DVT / PE \n\n known hypersensitivity to any of the study drugs or drugs with similar chemical structures \n\n Acute or history of heparin induced thrombocytopenia type II (HIT II) \n\n Other protocol-defined inclusion/", - "brief_summary": "This study is designed to provide efficacy and safety data for certoparin in the prophylaxis of venous thromboembolism in immobilized, acutely ill medical patients.", - "NCTID": "NCT00451412" - }, - { - "brief_title": "Echo Detection of Endoscopic Retrograde Cholangiopancreatography (ERCP) Air Embolus", - "phase": "", - "drugs": "['Transthoracic Echocardiography']", - "drugs_list": [ - "Transthoracic Echocardiography" - ], - "diseases": "['Air Embolism as A Complication of Medical Care']", - "diseases_list": [ - "Air Embolism as A Complication of Medical Care" - ], - "enrollment": "17.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject is undergoing ERCP as part of their medical care \n\n Subject will be of age 19 or older \n\n ", - "exclusion_criteria": ": \n\n Subject positioning for the ERCP is prone, thereby inhibiting the performance of the TTE \n\n Subject intolerance of the pressure of the TTE probe \n\n Subject body habitus interferes with obtaining adequate images to assess for intra-cardiac air", - "brief_summary": "Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopy technique to visualize and evaluate the pancreatic and biliary systems. It has been reported that rare instances of air embolus have been found associated with the performance of an ERCP and many of these events are fatal. It is our proposal to use transthoracic echocardiography to continuously evaluate for the presence of intra-cardiac air secondary to ERCP venous air embolism and attempt to quantify the incidence of this complication and any potential patient factors that might increase the risk of this complication.", - "NCTID": "NCT01535248" - }, - { - "brief_title": "PROSPER: PostpaRtum PrOphylaxiS for PE Randomized Control Trial Pilot", - "phase": "Phase 3", - "drugs": "['Dalteparin Sodium']", - "drugs_list": [ - "Dalteparin Sodium" - ], - "diseases": "['Venous Thromboembolism', 'Postpartum']", - "diseases_list": [ - "Venous Thromboembolism", - "Postpartum" - ], - "enrollment": "62.0", - "inclusion_criteria": "inclusion criteria: \n\n Women must be at high risk for thromboembolism for one of the following reasons: \n\n Known low risk thrombophilia (Known = diagnosed prior to enrollment and low risk thrombophilia includes heterozygous factor V Leiden or prothrombin gene variant or protein C deficiency or protein S deficiency. If not previously tested then assumed not to have thrombophilia). \n\n Immobilization (defined as >90% of waking hours in bed, of a week or more at any point in the antepartum period). \n\n OR any two of the following reasons: \n\n Postpartum infection (fever (temperature>38.5oC) and clinical signs/symptoms of infection and elevated neutrophil count (higher than local lab normal)) \n\n Postpartum hemorrhage (Estimated blood loss >1000 ml during delivery and postpartum) \n\n Pre-pregnancy BMI >25 kg/m2 \n\n Emergency cesarean birth (emergency = not planned prior to onset of labour) \n\n Smoking >5 cigarettes per day prior to pregnancy \n\n Preeclampsia (blood pressure \u2265 140mmHG systolic and/or \u226590 mmHg diastolic on at least one occasion and proteinuria (1+ on urine dipstick or 300mg/dl or total excretion of 300mg/24 hours) or typical end-organ dysfunction. \n\n Infant birth weight (adjusted for sex and gestational age) <3rd percentile (i.e., small for gestational age). \n\n ", - "exclusion_criteria": ": \n\n Less than 6 hours or more than 36 hours since delivery at the time of randomization \n\n Need for anticoagulation as judged by the local investigator, may include but not limited to: \n\n Personal history of previous provoked or unprovoked VTE (DVT or PE) \n\n Continuation of LMWH that was started in the antenatal period for VTE prophylaxis \n\n Mechanical heart valve \n\n Known high-risk thrombophilia (Known = diagnosed prior to enrolment and high-risk thrombophilia includes deficiency of antithrombin (at least 1 abnormal lab result), persistently positive anticardiolipin antibodies (> 30U/ml on two measurements a minimum of six weeks apart), persistently positive Anti B2 glycoprotein antibodies (> 20U/ml on two measurements a minimum of six weeks apart), persistently positive lupus anticoagulant (positive on two measurements a minimum of six weeks apart), homozygous factor V Leiden (FVL), homozygous prothrombin gene mutation (PGM), compound heterozygosity factor V Leiden (FVL) and prothrombin gene mutations (PGM), more than 1 thrombophilia (any combination of 2 or more: FVL, PGM, protein C deficiency, protein S deficiency). If not previously tested then assumed not to have thrombophilia). \n\n Contraindication to heparin therapy, including: \n\n History of heparin induced thrombocytopenia (HIT) \n\n Platelet count of less than 80,000 x 106/L on postpartum Complete Blood Count(CBC) \n\n Hemoglobin \u2264 75 g/L on postpartum CBC \n\n Active bleeding at any site (not resolved prior to randomization) \n\n Excessive postpartum vaginal bleeding (>1 pad per hour prior to randomization). \n\n Documented gastrointestinal ulcer within 6 weeks prior to randomization \n\n History of heparin or LMWH allergy \n\n Severe postpartum hypertension (systolic blood pressure (SBP) > 200mm/hg and/or diastolic blood pressure (DBP) > 120mm/hg) \n\n Severe hepatic failure (INR >1.8 if liver disease suspected) \n\n Have received more than one dose of heparin or LMWH since delivery \n\n < age of legal majority in local jurisdiction (age <18 in Canada) \n\n Prior participation in PROSPER \n\n Unable or refused to consent", - "brief_summary": "The purpose of this study is to determine if it is feasible to conduct a multi-center randomized trial to determine whether a blood thinner, low-molecular-weight-heparin (LMWH), is effective at preventing blood clots, thromboembolism (VTE), in postpartum women at risk.", - "NCTID": "NCT01274637" - }, - { - "brief_title": "Inhaled Prostacyclin for Adult Respiratory Distress Syndrome (ARDS) and Pulmonary Hypertension", - "phase": "", - "drugs": "['PGE1 (prostacyclin)', 'normal saline']", - "drugs_list": [ - "PGE1 (prostacyclin)", - "normal saline" - ], - "diseases": "['Adult Respiratory Distress Syndrome', 'Pulmonary Hypertension']", - "diseases_list": [ - "Adult Respiratory Distress Syndrome", - "Pulmonary Hypertension" - ], - "enrollment": "67.0", - "inclusion_criteria": "inclusion criteria: \n\n After obtaining informed consent the following patients will be included: \n\n All patients admitted to the ICU with pulmonary hypertension (mean PA > 35 mmHg). \n\n All patients in ICU with post operative pulmonary HTN (mean PA > 35 mm Hg). \n\n All patients with ARDS (PaO2/FiO2 < 200 - arterial hypoxemia, bilateral infiltrates on Chest X-ray infiltrates on CXR and a wedge < 20 mm Hg on swan ganz parameters) or signs of heart failure. \n\n ", - "exclusion_criteria": ": \n\n Patients to be excluded will be those with: \n\n Pulmonary embolus. \n\n Cor pulmonale. \n\n Ejection fraction of < 30%, wedge > 20 mm Hg. \n\n Non-intubated patients. \n\n Pediatric patients (< 16 yrs of age).", - "brief_summary": "Summary of the proposed research:~The intravenous application of prostacyclin (PGE1) or its stable analogue, iloprost, has been used to cause a decrease not only of the pulmonary but also of the systemic vascular tone. Aerosolized prostacyclin, on the other hand, can result in a selective pulmonary vasodilatation without affecting the systemic blood pressure as shown in preliminary studies/case reports. No large trials exist for this type of use of the drug so far. Furthermore, aerosolized PGI2 can improve gas exchange and pulmonary shunt in clinical settings of impaired ventilation/perfusion ratio as it occurs in adult respiratory distress syndrome (ARDS) due to the redistribution of pulmonary blood flow from non-ventilated to ventilated, aerosol accessible lung regions. Therefore, the investigators propose to carry out a prospective, double blinded, randomized trial to show that the nebulized iloprost decreases pulmonary hypertension selectively and improves oxygenation in ARDS.", - "NCTID": "NCT00314548" - }, - { - "brief_title": "A Preemptive Epidural Ropivacaine for Postoperative Pain Relief in Degenerative Lumbar Spine Surgery", - "phase": "Phase 4", - "drugs": "['Placebo (one of medication)', 'Ropivacaine (epidural injection)']", - "drugs_list": [ - "Placebo (one of medication)", - "Ropivacaine (epidural injection)" - ], - "diseases": "['Postoperative Pain']", - "diseases_list": [ - "Postoperative Pain" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n laminectomy \n\n ", - "exclusion_criteria": ": \n\n r/o infection \n\n reoperation \n\n mental change \n\n allergy to local anesthetics", - "brief_summary": "This prospective randomized study aims to evaluate the effectiveness of epidural injection of ropivacaine on the relief of pain in patients undergoing laminectomy.~Total 60 patients will be randomized into one of two groups (groupC or groupI) based on Excel number generation.~Patients in group C will receive no medication intraoperatively, and patients in group I will receive epidural injection of 0.1% ropivacaine 10ml before skin incision.~Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4,12,24,48 hour postoperatively.", - "NCTID": "NCT01117610" - }, - { - "brief_title": "Study of CPAP as Intervention After Lung Resection", - "phase": "", - "drugs": "['Cpap']", - "drugs_list": [ - "Cpap" - ], - "diseases": "['Lung Cancer', 'Pulmonary Complications']", - "diseases_list": [ - "Lung Cancer", - "Pulmonary Complications" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n medical diagnosis of lung cancer and an indication for lung resection (lobectomy, bilobectomy and pneumonectomy) with posterolateral thoracotomy; \n\n aged between 40 and 75 years. \n\n ", - "exclusion_criteria": ": \n\n Patients who refused to participate in the survey; \n\n lung resection with incisions other than posterolateral; \n\n patients who had contraindications to the use of noninvasive ventilation.", - "brief_summary": "The aim of this study was to compare the oxygenation index (OI), dyspnea, and pain scale and evaluate the duration of thoracic drainage and pleural air leaks after lung resection in two groups of patients: chest physiotherapy (CP) patients and combined CP and Continuous Positive Airway Pressure (CPAP) patients.", - "NCTID": "NCT01285648" - }, - { - "brief_title": "Clinical Trial Evaluating the Optimal Technique for Chest Tube Removal", - "phase": "", - "drugs": "['Chest tube pull on inspiration', 'Expiration']", - "drugs_list": [ - "Chest tube pull on inspiration", - "Expiration" - ], - "diseases": "['Chest Tube Removal']", - "diseases_list": [ - "Chest Tube Removal" - ], - "enrollment": "342.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who are post thoracotomy, pulmonary resection (wedge, lobectomy, segmentectomy, pneumonectomy), AND \n\n Have at least one chest tube. \n\n ", - "exclusion_criteria": ": \n\n Less than 19 years old, \n\n With interstitial lung disease, OR \n\n Any patient intubated.", - "brief_summary": "There are two commonly used methods to remove chest tubes following thoracotomy. One is to remove the chest tube at maximum inspiration, (patient is asked to take a deep breath in and hold it), and the other is to pull the chest tube at maximum expiration,(patient is asked to blow out as much air as they can can and hold it). There has been considerable discussion among Thoracic surgeons that one of these two methods may decrease the risk of pneumothorax, the most common complication associated with chest tube removal. The investigators will compare the two methods, and also identify risk factors of developing pneumothorax during chest tube removal.", - "NCTID": "NCT00873587" - }, - { - "brief_title": "Comparative Study of Prophylactic Agent for Venous Thromboembolism After Total Knee Arthroplasty", - "phase": "Phase 2", - "drugs": "['acetylsalicylic acid', 'rivaroxaban']", - "drugs_list": [ - "acetylsalicylic acid", - "rivaroxaban" - ], - "diseases": "['Venous Thromboembolism']", - "diseases_list": [ - "Venous Thromboembolism" - ], - "enrollment": "156.0", - "inclusion_criteria": "inclusion criteria: \n\n all patients undergone primary total knee arthroplasty \n\n ", - "exclusion_criteria": ": \n\n renal insufficiency, contrast allergy, simultaneous bilateral TKA, hemorrhagic disorder, sever liver disease", - "brief_summary": "The purpose of this study is to compare the efficacy of two prophylactic agent(aspirin 300mg/day and rivaroxaban 10mg/day) for venous thromboembolism after total knee arthroplasty.", - "NCTID": "NCT02271399" - }, - { - "brief_title": "Noninvasive Continuous Positive Airway Pressure (NCPAP) in Children", - "phase": "Phase 3", - "drugs": "['NCPAP by helmet', 'NCPAP by facial mask']", - "drugs_list": [ - "NCPAP by helmet", - "NCPAP by facial mask" - ], - "diseases": "['Acute Respiratory Failure']", - "diseases_list": [ - "Acute Respiratory Failure" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n PaO2/FiO2 ratio <300 \n\n Respiratory rate >50 breaths/min \n\n Chest x-ray compatible with pulmonary infection \n\n No clinical improvement after breathing oxygen at 8 l/min or more for at least 15 min \n\n ", - "exclusion_criteria": ": \n\n Presence of an endotracheal tube or a tracheostomy before PICU admission \n\n Facial deformities \n\n Upper airway obstruction \n\n Cyanotic congenital heart disease \n\n Facial trauma \n\n Recurrent apnea \n\n Neuromuscular weakness \n\n Pulmonary hypoplasia \n\n Pulmonary vascular anomalies \n\n Imminent respiratory or cardiac arrest \n\n COPD and/or chronic CO2 retention \n\n Status asthmaticus \n\n Pneumothorax \n\n Hemodynamic instability \n\n Alteration in consciousness with a Glasgow coma score (GCS) <10 \n\n Aspiration or excessive bronchial secretions \n\n Enrollment in other research protocol", - "brief_summary": "In critically ill pediatric patients with Acute Respiratory Failure (ARF), Noninvasive Continuous Positive Airway Pressure (NCPAP) is applied to avoid intubation and all related complications such as tracheal injury and predisposition to nosocomial pulmonary infections. The choice of the interface is one of the crucial issues affecting treatment outcome in pediatric age and in particular in preschool children in whom intolerance frequently compromise noninvasive respiratory treatment. NCPAP is applied either through nasal or facial tight fitting masks and the most important principle in guiding the selection of an interface is that it should fit comfortably. However, while nasal mask can leak gas when the infant opens his/her mouth, facial mask can cause significant gastric distension and vomiting, with risk of aspirating gastric contents. Moreover, complications such as air leaks, skin irritation on the bridge of the nose, and discomfort reported with nasal or facial masks in children frequently lead to interruption of the respiratory treatment. Thus, improving the interface between the patient and the ventilator would be expected to facilitate longer and more effective application of NCPAP.~A new small helmet specifically designed for young infants has been recently introduced to administer NCPAP. In a recent short term crossover physiological randomized controlled trial, the investigators found that NCPAP by helmet was associated with enhanced feasibility, less need of sedation and prolonged application time (see references below). The purpose of this prospective randomized multicenter study is to compare the efficacy and feasibility of NCPAP delivered either by helmet or by facial mask to treat acute respiratory failure in infants admitted to Pediatric Intensive Care Unit (PICU).", - "NCTID": "NCT01242150" - }, - { - "brief_title": "The Effects of Surgery for Painful External Snapping Hip", - "phase": "", - "drugs": "['Surgery for external snapping hip']", - "drugs_list": [ - "Surgery for external snapping hip" - ], - "diseases": "['Hip Pain']", - "diseases_list": [ - "Hip Pain" - ], - "enrollment": "62.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients undergoing surgery for painful external snapping hip \n\n 18 years or older \n\n ", - "exclusion_criteria": ": \n\n Inability to comply with the protocol (e.g. due to dementia)", - "brief_summary": "The purpose of this study is to assess the pain-relieving effects of surgery for painful external snapping hip.", - "NCTID": "NCT02204514" - }, - { - "brief_title": "Exparel in Minimally Invasive Cardiac Surgery", - "phase": "Phase 4", - "drugs": "['Exparel infiltration']", - "drugs_list": [ - "Exparel infiltration" - ], - "diseases": "['Cardiac Disease']", - "diseases_list": [ - "Cardiac Disease" - ], - "enrollment": "9.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients aged 18-75 years inclusive and American Society of Anesthesiologists physical status 2-4. \n\n Undergoing minimally invasive cardiac surgery. \n\n Subjects must be physically and mentally able to participate in the study and complete all study assessments. \n\n Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of thoracotomy and chest tube sites infiltration. \n\n ", - "exclusion_criteria": ": \n\n History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics \n\n Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a thoracotomy and chest tube sites infiltration. \n\n Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study. \n\n Any subject, who in the opinion of the Investigator, is on chronic pain medicine, including large doses of nonsteroidal antiinflammatory drugs. \n\n Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.", - "brief_summary": "The investigators are presently using Exparel, a slow released local anesthestic, in patients undergoing minimally invasive cardiac surgery. The primary objective of this study is to assess the efficacy of EXPAREL when delivered into the thoracotomy and chest tube sites to provide prolonged postoperative analgesia in patients undergoing minimally invasive cardiac surgery. Efficacy will be assessed by: the effectiveness of analgesia as measured by the subject's overall postoperative pain scores and postsurgical analgesic use.", - "NCTID": "NCT02008370" - }, - { - "brief_title": "CT Calcium Scoring in Suspected Stable Angina", - "phase": "", - "drugs": "['CT calcium scoring']", - "drugs_list": [ - "CT calcium scoring" - ], - "diseases": "['Coronary Disease']", - "diseases_list": [ - "Coronary Disease" - ], - "enrollment": "705.0", - "inclusion_criteria": "inclusion criteria: \n\n non-acute chest pain \n\n those who underwent CT calcium scoring \n\n availability of all relevant risk factor information \n\n ", - "exclusion_criteria": ": \n\n previous coronary disease i.e., myocardial infarction or revascularization", - "brief_summary": "Patients with stable chest pain presenting to general practitioners in UK are routinely referred to the chest pain clinics in the hospitals. They are assessed by clinical history including risk factors, cardiovascular exam, resting ECG, chest x-ray, and exercise ECG. CT calcium scoring (CTCS) is a technique that is very sensitive in identifying and quantifying calcified atherosclerotic plaques. Recent guidance from the National Institute of Clinical Excellence (NICE, citation 1) proposes the use of CTCS in patients with stable chest pain who have low likelihood of coronary artery disease (CAD). They recommend that patients with low likelihood (10-30%) have a CTCS and if the score is 0, they can be considered to have non-cardiac chest pain. However, there is controversy regarding relationship of absent calcification with significant CAD and its prognostic value.~At our institution, we have been performing CTCS in this patient cohort since 2003. We plan to retrospectively review the usefulness in CTCS in patients with different likelihood for significant CAD, particularly in patients with absent calcium and compare with the traditional assessment. We also plan to follow-up these patients for any myocardial infarction and death from any cause.", - "NCTID": "NCT01660594" - }, - { - "brief_title": "The Effect of a Respiratory Muscle Warm-up Prior to Exercise in Patients With Chronic Obstructive Pulmonary Disease", - "phase": "", - "drugs": "['Inspiratory Warm Up', 'Expiratory Warm Up', 'Combination Warm Up', 'Control Trial']", - "drugs_list": [ - "Inspiratory Warm Up", - "Expiratory Warm Up", - "Combination Warm Up", - "Control Trial" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "5.0", - "inclusion_criteria": "inclusion criteria: \n\n A clinical diagnosis of COPD \n\n Aged between 35 and 90 years \n\n Able to fluently read and speak English \n\n Willing and able to sign informed consent \n\n Be able to comply with the procedures outlined for the study \n\n ", - "exclusion_criteria": ": \n\n Cardiac disease (including arrhythmias) \n\n A medicinal requirement for rate limiting calcium antagonists or beta blockers \n\n Cerebrovascular disease \n\n Peripheral vascular disease \n\n Requirement for supplemental oxygen therapy \n\n CO2 (carbon dioxide) retention \n\n Malignancy \n\n Orthopaedic or neurological conditions effecting the ability to exercise \n\n Clinically apparent heart failure \n\n Renal, hepatic or inflammatory disease \n\n Instability of COPD \n\n Any other reason leading to the inability to complete the requirements of the study. \n\n Additionally: If participants have a resting HR above 120beats.min-1, systolic blood pressure above 180mm Hg or diastolic blood pressure above 100mm Hg prior to the 6 minute walk test they will not be able to commence the test.", - "brief_summary": "The purpose of this study is to investigate the effects of performing a breathing muscle warm up before exercise in patients who have chronic obstructive pulmonary disease (COPD). The main aim is to see whether performing a breathing muscle warm up can improve distance walked in a 6 minute walk test and also decrease perceptions of effort and breathlessness.", - "NCTID": "NCT02532075" - }, - { - "brief_title": "The Effect of Intravenous Lidocaine on Pain After Tonsillectomy", - "phase": "Phase 4", - "drugs": "['Intravenous lidocaine injection', 'Intravenous normal saline injection']", - "drugs_list": [ - "Intravenous lidocaine injection", - "Intravenous normal saline injection" - ], - "diseases": "['Postoperative Pain']", - "diseases_list": [ - "Postoperative Pain" - ], - "enrollment": "62.0", - "inclusion_criteria": "inclusion criteria: \n\n Tonsillectomy \n\n ", - "exclusion_criteria": ": \n\n mental change \n\n allergy to local anesthetics", - "brief_summary": "This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing tonsillectomy.~A total of 62 patients will be randomized into one of two groups (group C or group I) based on Excel number generation.~Patients in group C will receive received normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.~Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4, 12, 24, 48 hours postoperatively.", - "NCTID": "NCT01291979" - }, - { - "brief_title": "Electrical Skin Conductance Monitoring as an Assessment of Post Operative Pain Scores", - "phase": "", - "drugs": "['Total Hip Replacement (THR) and Total Knee Replacement (TKR)']", - "drugs_list": [ - "Total Hip Replacement (THR) and Total Knee Replacement (TKR)" - ], - "diseases": "['Postoperative Pain']", - "diseases_list": [ - "Postoperative Pain" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients undergoing unilateral THR and TKR who are between the ages of 18 and 85 regardless of the anesthesia and postoperative analgesia type. \n\n Patients participating in other studies may participate in this study as well \n\n Patients with Motor Activity Assessment Scale (MAAS) Score of 3 and 4 \n\n ", - "exclusion_criteria": ": \n\n Age <18, >85 \n\n History of chronic pain as defined by use of long acting opioid medication > 6 months duration. \n\n MAAS Score of <3 and >4. \n\n Anticholinergic agent use \n\n Patients with the following conditions: \n\n Autonomic neuropathy \n\n Pacemaker/AICD \n\n Burn patients or patients with severe dermatologic conditions (as defined by skin conditions causing further pain to patients that actively has to be treated) \n\n Allergy to adhesive tape \n\n Communication barriers \n\n Bilateral Procedures \n\n Patient with diagnosis of \n\n Dysautonomia \n\n Sympathetic dysfunction such as: Raynaud disease, Buerger disease \n\n Disorders of sweating such as: Acquired idiopathic generalized anhidrosis", - "brief_summary": "Pain has been defined as a subjective experience. Various pain assessment tools, (such as NRS) have been developed and validated to objectively monitor and treat pain. There are certain patient populations, in whom, the current pain assessment tools cannot be used effectively due to communication problems such as cognitively impaired patients. In the US, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has made it mandatory to monitor and treat pain. In the absence of reliable pain assessment tools that would objectively measure pain, there is also risk of under treatment and overtreatment of pain that may lead to negative outcomes. Therefore, a monitor that is able to predict pain levels objectively, will help to achieve above goals. The investigators are using Skin Conductance Algesimeter (SCA) to measure pain by analyzing changes in skin conductance.", - "NCTID": "NCT02408263" - }, - { - "brief_title": "The Effect of Intravenous Lidocaine and Intraperitoneal Lidocaine Irrigation on Pain After Laparoscopic Cholecystectomy", - "phase": "Phase 4", - "drugs": "['Intravenous lidocaine injection', 'Intraperitoneal lidocaine irrigation group', 'Intravenous normal saline injection']", - "drugs_list": [ - "Intravenous lidocaine injection", - "Intraperitoneal lidocaine irrigation group", - "Intravenous normal saline injection" - ], - "diseases": "['Postoperative Pain']", - "diseases_list": [ - "Postoperative Pain" - ], - "enrollment": "83.0", - "inclusion_criteria": "inclusion criteria: \n\n Laparoscopic cholecystectomy \n\n ", - "exclusion_criteria": ": \n\n mental change \n\n allergy to local anesthetics", - "brief_summary": "This prospective randomized study aims to comparison the effectiveness of intravenous lidocaine injection and intraperitoneam lidocaine irrigation on the relief of pain in patients undergoing laparoscopic cholecystectomy.~A total of 83 patients will be randomized into one of three groups (group C or group I or group P) based on Excel number generation.~Patients in group C will receive normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.~Patients in group P will receive intraperitoneal lidocaine irrigation with 3.5 mg/kg lidocaine and normal saline 100cc.~Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 2, 4, 8, 12, 24, 48 hours postoperatively.", - "NCTID": "NCT01608373" - }, - { - "brief_title": "The Effect of Intravenous Lidocaine on Pain After Lumbar Spinal Fusion", - "phase": "Phase 4", - "drugs": "['Intravenous lidocaine injection', 'Intravenous normal saline injection']", - "drugs_list": [ - "Intravenous lidocaine injection", - "Intravenous normal saline injection" - ], - "diseases": "['Postoperative Pain']", - "diseases_list": [ - "Postoperative Pain" - ], - "enrollment": "54.0", - "inclusion_criteria": "inclusion criteria: \n\n 1-level posterior lumbar fusion \n\n ", - "exclusion_criteria": ": \n\n mental change \n\n allergy to local anesthetics \n\n chronic analgesics user", - "brief_summary": "This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing 1-level posterior lumbar fusion.~A total of 54 patients will be randomized into one of two groups (group C or group I) based on Excel number generation.~Patients in group C will receive received normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.~Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4, 12, 24, 48 hours postoperatively.", - "NCTID": "NCT01319682" - }, - { - "brief_title": "Prescription and Utilization of Low Molecular Weight Heparin in Usual Medical Practice for the Curative Treatment of Venous Thromboembolism in Patients With Cancer", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Venous Thromboembolism']", - "diseases_list": [ - "Venous Thromboembolism" - ], - "enrollment": "419.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects must provide informed consent \n\n Men or women aged 18 years or more \n\n Ongoing cancer disease recent diagnosis of veinous thromboembolism treatment with Low Molecular Weight Heparin before entry into the study \n\n ", - "exclusion_criteria": ": \n\n - Contraindication to the use of Low Molecular Weight Heparin", - "brief_summary": "The study purpose is to document the prescription and the use of Low Molecular Weight Heparin in usual medical practice in patients with cancer and established Venous Thromboembolism. This study also aims at gathering epidemiological data on the Low Molecular Weight Heparin therapy of Venous Thromboembolism in patients with cancer.", - "NCTID": "NCT01803022" - }, - { - "brief_title": "The Effect of Intravenous Lidocaine on Pain After Thyroidectomy", - "phase": "Phase 4", - "drugs": "['Intravenous lidocaine injection', 'Intravenous normal saline injection']", - "drugs_list": [ - "Intravenous lidocaine injection", - "Intravenous normal saline injection" - ], - "diseases": "['Postoperative Pain']", - "diseases_list": [ - "Postoperative Pain" - ], - "enrollment": "56.0", - "inclusion_criteria": "inclusion criteria: \n\n Total thyroidectomy \n\n ", - "exclusion_criteria": ": \n\n mental change \n\n allergy to local anesthetics", - "brief_summary": "This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing thyroidectomy.~A total 56 patients will be randomized into one of two groups(group C or group I) based on Excel number generation.~Patients in group C will receive normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5mg/kg lidocaine followed by a continuous lidocaine infusion of 2mg/kg/hr.~Visual analogue scale pain scores, fentanyl consumption, the frequency at which patients pushed the button(FPB) of a patient-controlled analgesia system, and presence or absence of nausea and vomiting will be recorded at 2,4,8,12,24,48 hours postoperatively.", - "NCTID": "NCT01608360" - }, - { - "brief_title": "Analgesic Control Following Knee Arthroscopy", - "phase": "", - "drugs": "['Intraarticular injection', 'Intra-articular injection of 0.5% Bupivacaine']", - "drugs_list": [ - "Intraarticular injection", - "Intra-articular injection of 0.5% Bupivacaine" - ], - "diseases": "['Knee', 'Arthroscopy', 'Analgesia']", - "diseases_list": [ - "Knee", - "Arthroscopy", - "Analgesia" - ], - "enrollment": "98.0", - "inclusion_criteria": "inclusion criteria: \n\n those undergoing knee arthroscopy for: diagnostic purposes, removal of loose bodies, articular cartilage debridement or, meniscectomy \n\n age over 18 years \n\n ", - "exclusion_criteria": ": \n\n American Society of Anaesthesiologists (ASA) grade \u22653; \n\n arthroscopic assisted osteotomies; \n\n a history of two or more prior procedures on the ipsilateral knee; \n\n post-operative morbidities indirectly linked to the procedure (e.g. anaesthetic complications, DVT or PE); \n\n systemic steroid requirements; \n\n previous intra-articular anaesthetic or steroid injection within the last three months; \n\n intra-articular HA injection within the last nine months; \n\n intra-articular sepsis within the previous three months; \n\n prior history of knee arthroplasty, peri-articular fracture, ligamentous instability, inflammatory arthritis or a previous diagnosis of Complex Regional Pain Syndrome.", - "brief_summary": "This study aims to investigate the analgesic effects offered by bupivacaine and Durolane (a hyaluronic acid supplement) administered immediately following the completion of knee arthroscopy.", - "NCTID": "NCT01169389" - }, - { - "brief_title": "Quantifying Lung Tumor Movement Under Deep Inspiration Breath Holds", - "phase": "", - "drugs": "['CT scan of the chest under deep inspiration breath hold']", - "drugs_list": [ - "CT scan of the chest under deep inspiration breath hold" - ], - "diseases": "['Lung Cancer']", - "diseases_list": [ - "Lung Cancer" - ], - "enrollment": "8.0", - "inclusion_criteria": "inclusion criteria: \n\n biopsy confirmed primary lung cancer \n\n undergoing radiotherapy or chemoradiotherapy \n\n able to perform adequate deep inspiration breath hold \n\n patients of childbearing potential must practice adequate contraception \n\n signed study-specific informed consent form \n\n ", - "exclusion_criteria": ": \n\n unable to perform adequate deep inspiration breath hold \n\n prior tumor resection \n\n prior chest or neck RT \n\n pregnant", - "brief_summary": "Radiotherapy is a common treatment for lung cancer. One Challenge of delivering radiation treatment to lung tumors accurately is tumor movement which occurs as a patient breathes. In some situations, tumors move enough during breathing so that some or all of the tumor may be missed by a radiation treatment. One way to decrease the amount a lung tumor moves during radiotherapy treatments is for patients to held their breath briefly during a radiation treatment. By doing this, a patient's lung tumor may not move as much as it would during regular breathing. In this study, the investigators aim to study patients with lung cancers which move during breathing. Patients will be asked to hold their breath after inspiration while a CT scan of their lung tumor is obtained. The purpose of this study is to study how much less patients' lung tumors move when they hold their breath", - "NCTID": "NCT00643370" - }, - { - "brief_title": "Autologous Redirected RNA Meso-CIR T Cells", - "phase": "Phase 1", - "drugs": "['Autologous T cells']", - "drugs_list": [ - "Autologous T cells" - ], - "diseases": "['Malignant Pleural Mesothelioma']", - "diseases_list": [ - "Malignant Pleural Mesothelioma" - ], - "enrollment": "18.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects must have histologically confirmed MPM (epithelial or biphasic). \n\n Subjects must have completed standard first line therapy with a platinum-based double regimen and had PD or they must have chosen not to pursue primary standard of care therapy. \n\n ECOG performance status 0 to 1. \n\n Age greater than 18 years \n\n Life expectancy > 4 months \n\n At least 2 weeks since prior and no other concurrent chemotherapy, radiotherapy, or immunotherapy (e.g., interferons, tumor necrosis factor, interleukins, or monoclonal antibodies). In addition, the patient must have fully recovered from any adverse events related to these agents. \n\n More than 4 weeks since prior and no other concurrent investigational agents. \n\n Subjects must have measurable disease as defined by accepted MPM measurement techniques (modified RECIST criteria). \n\n Blood coagulation parameters: PT such that international normalized ratio (INR) is < 1.5 (or an in-range INR, usually between 2 and 3, if a subject is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thromboembolus) and a PTT < 1.2 times the upper limit of normal. \n\n Subjects must have adequate venous peripheral access for apheresis. Patients must also have adequate venous access for subsequent modified CIR T-cell administration which can be done through a central venous access (e.g. port of systemic chemotherapy). \n\n Short-term therapy for acute conditions not specifically related to MPM is allowed if such therapy does not include any immune modulating agents. \n\n Male and Female subjects agree to use approved contraceptive methods (e.g. birth control pills, barrier device, intrauterine device , abstinence) during the study and for 3 months following the last dose of the study cell infusion. \n\n Subject must understand and sign the study-specific informed consent . \n\n Satisfactory organ and bone marrow function as defined by : \n\n Absolute neutrophil count > 1,000/\u00b5l Platelets > 100,000/\u00b5l Hematocrit > 30 % AST(SGOT)/ALT(SGPT) < 3x the institutional normal upper limit Bilirubin < 2.0 mg/dL unless secondary to malignant bile duct obstruction Creatinine < 1.5x the institutional normal upper limit \n\n ", - "exclusion_criteria": ": \n\n Previously treated with any investigation therapy within 1 month prior to screening. \n\n Sacromatoid MPM histology which does not express mesothelin \n\n Prior invasive malignancies unless surgically and medically cured without evidence of recurrent disease for 5 years with the exception of non-melanoma skin cancer, prostate cancer with PSA level < 1.0. \n\n Prior hematologic malignancy with bone marrow transplantation or immune modifying therapy within the past 4 weeks with the exception of thyroid replacement. \n\n Use of immunosuppressive drugs with 4 weeks prior to study entry, or anticipated use of immunosuppressive agents. \n\n Any clinically -significant pericardial effusion, CHF (NY Heart Association Grade II-IV ), or cardiovascular condition. \n\n Any clinically -significant pleural effusion or ascites that cannot be drained with standard approaches or with pre-enrollment in dwelling drainage device placement. \n\n Forced vital capacity < 50% predicted, DLCO < 40% predicted. \n\n Underlying lung disease requiring supplemental oxygen therapy. \n\n Have a recognized immunodeficiency disease including cellular immunodeficiency, hypogammaglobulinemia, or dysgammaglobulinemia; patients who have acquired hereditary, congenital immunodeficiency. \n\n Viral infections: HIV, HCV, HBV. \n\n Pregnant women are excluded from this study because autologous transduced T cells, breastfeeding should be discontinued if the mother is treated. \n\n Feasibility assessment during screening demonstrates < 30% transfection of target lymphocytes, or < 5-fold expansion in modified CIR T-cells in response to CD3/CD28 costimulation.", - "brief_summary": "To determine the safety and manufacturing feasibility of IV autologous chimeric immune receptor (CIR) T cells transfected with anti-mesothelin messenger RNA (mRNA) expressing a single chain antibody variable fragment linked to the intracellular CD 3 zeta T cell receptor domain and the 4-1BB costimulatory domain.", - "NCTID": "NCT01355965" - }, - { - "brief_title": "Triathlon\u00ae Posteriorly Stabilized (PS) Total Knee System - Outcomes Study", - "phase": "", - "drugs": "['Triathlon\u00ae PS Total Knee System']", - "drugs_list": [ - "Triathlon\u00ae PS Total Knee System" - ], - "diseases": "['Arthroplasty, Replacement, Knee']", - "diseases_list": [ - "Arthroplasty", - "Replacement", - "Knee" - ], - "enrollment": "409.0", - "inclusion_criteria": "inclusion criteria: \n\n The subject is a male or non-pregnant female 21-80 years of age at the time of enrollment. \n\n The subject requires a primary cemented total knee replacement. \n\n The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN). \n\n The subject has intact collateral ligaments. \n\n The subject has signed the IRB approved, study specific Informed Patient Consent Form. \n\n The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation. \n\n ", - "exclusion_criteria": ": \n\n The subject has inflammatory arthritis. \n\n The subject is morbidly obese, BMI > 40. \n\n The subject has a history of total or unicompartmental reconstruction of the affected joint. \n\n The subject has had a high tibial osteotomy or femoral osteotomy. \n\n The subject has a neuromuscular or neurosensory deficiency that would limit the ability to assess the performance of the device. \n\n The subject has a systemic or metabolic disorder leading to progressive bone deterioration. \n\n The subject is immunologically suppressed, or receiving chronic steroids (>30 days duration). \n\n The subject's bone stock is compromised by disease or infection and cannot provide adequate support and/or fixation to the prosthesis. \n\n The subject has had a knee fusion at the affected joint. \n\n The subject has an active or suspected latent infection in or about the knee joint. \n\n The subject is a prisoner.", - "brief_summary": "The purpose of this study is to evaluate the clinical outcomes (range of motion, pain, function, radiographic stability, and health related quality of life) of patients receiving the Triathlon\u00ae Posterior Stabilized (PS) Total Knee System. These outcomes will be evaluated using pre-operative scores and comparing them to post-operative scores in addition to being compared with cases who received the Scorpio\u00ae PS implant.", - "NCTID": "NCT00957021" - }, - { - "brief_title": "Assessment of Ability of Breath Hold for Left-sided Breast Cancer Radiation Therapy to Reduce Side Effects to Heart", - "phase": "", - "drugs": "['Cardiac SPECT perfusion scan']", - "drugs_list": [ - "Cardiac SPECT perfusion scan" - ], - "diseases": "['Breast Cancer']", - "diseases_list": [ - "Breast Cancer" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n signed an Institutional Review Board (IRB)-approved informed consent document for protocol \n\n age >= 18 years \n\n histologically confirmed left-sided breast cancer scheduled to undergo curative intent radiation treatment post lumpectomy or mastectomy \n\n stage 0-III left-sided breast cancer (including DCIS) \n\n SPECT score of 0 at baseline \n\n radiation oncologist agrees target volume coverage will not be compromised via use of the DIBH technique along with conformal field shaping \n\n ", - "exclusion_criteria": ": \n\n active cardiac disease, defined as a history of angina, arrhythmias, myocardial infarction, congestive heart failure, or any other cardiac condition, which in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient \n\n symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators \n\n concurrent chemotherapy \n\n prior receipt of mediastinal radiation therapy \n\n pregnant or lactating women \n\n inability to understand and follow breathing instructions for the DIBH procedure", - "brief_summary": "The purpose of this research study is to demonstrate that Deep Inspiration Breath Hold (DIBH), the technique used at the University of North Carolina (UNC) for left-side breast cancer radiation therapy, can reduce side effects to the heart.", - "NCTID": "NCT01849614" - } - ], - "1": [ - { - "brief_title": "Italian Pulmonary Embolism Registry - IPER", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Acute Pulmonary Embolism']", - "diseases_list": [ - "Acute Pulmonary Embolism" - ], - "enrollment": "1700.0", - "inclusion_criteria": "inclusion criteria: \n\n consecutive patients with acute pulmonary embolism \n\n ", - "exclusion_criteria": ": \n\n age <18 years", - "brief_summary": "RAZIONALE~Pulmonary embolism is a complex disease, with a highly variable clincal presentation. Diagnosis starts with clinical probability assessment mainly based on medical history and rapidly available clinical data. Pulmonary embolism can be managed by emergency department, cardiology, pneumology geriatrics or internal medicine physicians. Thus, initial clinical management can varies based on the attitude of the attending physician.~Diagnosis is a crucial point as it can influence short term mortality.~OBJECTIVE~The registry has 3 main objectives:~educational objective,~improvement in the knowledge of epidemiology, management and outcome of acute pulmonary embolism in Italy~scientific objective", - "NCTID": "NCT01604538" - }, - { - "brief_title": "Once Daily Enoxaparin for Outpatient Treatment of Acute DVT and/or Pulmonary Embolism", - "phase": "", - "drugs": "['Enoxaparin']", - "drugs_list": [ - "Enoxaparin" - ], - "diseases": "['Deep Vein Thrombosis', 'Pulmonary Embolism']", - "diseases_list": [ - "Deep Vein Thrombosis", - "Pulmonary Embolism" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Symptomatic acute deep venous thrombosis and/or pulmonary embolism confirmed by venous ultrasound and/or CT scan. \n\n Pulmonary embolism patients with normal right ventricular size on chest CT scan. \n\n Age greater than 18 years \n\n Anticipated discharge within 72 hours of admission \n\n Written informed consent \n\n ", - "exclusion_criteria": ": \n\n Pregnancy or intend to become pregnant \n\n Patients requiring ongoing hospitalization > 72 hours \n\n Hypersensitivity to heparin, pork products or enoxaparin \n\n Creatinine > 2.0 mg/dl \n\n Recurrent DVT and/or PE with oral anticoagulation \n\n Surgery or medical procedure planned during the study that may pose a significant bleeding risk \n\n Prior history of heparin-induced thrombocytopenia \n\n Inability to participate for follow up appointments and study visits \n\n Life expectancy < 30 days \n\n High risk of bleeding: \n\n Active major bleeding within 30 days by GUSTO criteria \n\n History of intracranial bleeding \n\n Major surgery or trauma within 10 days \n\n Head injury requiring hospitalization within 1 year \n\n Intracranial tumor \n\n Neurosurgery or non-cataract ophthalmologic surgery within 1 month \n\n Thrombocytopenia", - "brief_summary": "To investigate the efficacy and safety of once daily enoxaparin as a bridge to warfarin for the outpatient treatment of acute deep venous thrombosis or pulmonary embolism.", - "NCTID": "NCT00413374" - }, - { - "brief_title": "Outpatient Treatment of Low-risk Pulmonary Embolism", - "phase": "", - "drugs": "['Outpatient Treatment of Pulmonary Embolism']", - "drugs_list": [ - "Outpatient Treatment of Pulmonary Embolism" - ], - "diseases": "['Pulmonary Embolism']", - "diseases_list": [ - "Pulmonary Embolism" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Pulmonary Embolism, diagnosed by CTA or high probability VQ Scan \n\n Total Pulmonary Embolism Severity Index (PESI) score <86 \n\n ", - "exclusion_criteria": ": \n\n Massive Pulmonary Embolism: Hypotension with signs of right heart strain on CTA or Echocardiogram \n\n Sustained Systolic Blood Pressure (SBP) <95 mmHg during Emergency Department or observation stay. \n\n Age <18 \n\n Pregnant \n\n Renal insufficiency (Creatinine Clearance <30) \n\n Hepatic Dysfunction (AST/ALT/ALP > 3 times upper limit of normal) \n\n Unreliable social situation or inability to follow up \n\n Contraindication to enoxaparin, warfarin and rivaroxaban \n\n Atrial or ventricular dysrhythmia(s)", - "brief_summary": "This study is looking at the safety and effectiveness of treating Patients diagnosed with a low-risk Pulmonary Embolism (PE) in an outpatient setting instead of the standard, in-patient hospitalization. Patients have several medical tests done during their Emergency Department visit. Based on those tests, those who are determined to have a low-risk PE are eligible to participate in the study. Those choosing to participate are discharged after 12 hours of medical observation. Patients who choose to participate are followed up by telephone approximately 90 days later.", - "NCTID": "NCT02355548" - }, - { - "brief_title": "Arixtra PE Study- Outpatient Management of Stable Acute Pulmonary Embolism: Once Daily Subcutaneous Fondaparinux", - "phase": "", - "drugs": "['Fondaparinux']", - "drugs_list": [ - "Fondaparinux" - ], - "diseases": "['Pulmonary Embolism']", - "diseases_list": [ - "Pulmonary Embolism" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients enrolled into the trial must meet all of the following criteria: \n\n At least 18 years of age and able to provide informed consent \n\n Objectively confirmed symptomatic APE [intraluminal filling defect on spiral computed tomography (CT) or pulmonary angiography, or high- probability ventilation-perfusion (V/Q)lung scan \n\n Stable and low risk defined as: \n\n Hemodynamically stable (HR\u2264120, no hypotension, no tachypnea, no mental status change, no shock state) \n\n O2 supplement \u22644 L/NC \n\n Lack of electrocardiographic or echocardiographic evidence for new RV strain \n\n Radiographically non-massive PE (absence of saddle emboli on PA gram or spiral CT, perfusion defect on V/Q scan <50% \n\n No significant cardiac abnormalities (EF<35%, unstable angina, positive stress test within the past 3 months without revascularization) or pulmonary disease (severe COPD, pulmonary HTN). \n\n Negative cardio-specific biomarkers obtained at baseline (TNT, BNP) \n\n No moderate or severe RV dysfunction on echocardiogram \n\n Women of childbearing potential must have a negative pregnancy test (urine or serum) within 24 hours of enrollment \n\n ", - "exclusion_criteria": ": \n\n Patients meeting one or more of the following criteria are not eligible for enrollment into the trial: \n\n In the opinion of the clinician, the patient should receive in-patient standard medical therapy \n\n Contraindication for anticoagulation therapy (active or recent bleeding, recent surgery, bleeding diathesis, recent neurologic event) \n\n Is receiving therapeutic doses of UFH or LMWH for >24 hours \n\n Thrombolytic or glycoprotein IIb/IIIa agents administered within 24 hours prior to enrollment \n\n Platelet count <100,000 \n\n Creatinine clearance <30 mL/min at time of enrollment \n\n Presence of neuraxial anesthesia and/or post-operative indwelling epidural catheter \n\n Known history of antiphospholipid antibody syndrome \n\n Weight >150 kg (330.7 lbs) or <45 kg (99.2 lbs) \n\n Life expectancy \u22643 months \n\n Associated arterial thrombosis \n\n Heparin induced thrombocytopenia (HIT) diagnosed within the past 100 days \n\n IVC filter \n\n Any condition that in the opinion of the investigator will prohibit compliance with study procedures and treatment", - "brief_summary": "To assess the safety and efficacy of outpatient treatment using fondaparinux and oral Vit K antagonist, warfarin (Coumadin) in patients with stable acute pulmonary embolus (APE)when initial therapy is administered in the hospital. Prospectively validate risk stratification criteria for predicting patient suitability for outpatient treatment of acute pulmonary embolism.", - "NCTID": "NCT00378027" - }, - { - "brief_title": "Safety Study of Outpatient Treatment for Pulmonary Embolism", - "phase": "Phase 3", - "drugs": "['Outpatient care (vs traditional inpatient care)']", - "drugs_list": [ - "Outpatient care (vs traditional inpatient care)" - ], - "diseases": "['Pulmonary Embolism']", - "diseases_list": [ - "Pulmonary Embolism" - ], - "enrollment": "343.0", - "inclusion_criteria": "inclusion criteria: \n\n age >18 years \n\n objectively confirmed diagnosis of pulmonary embolism \n\n patients at low-risk (Pulmonary Embolism Severity Index score <=85) \n\n ", - "exclusion_criteria": ": \n\n patients at high-risk (Pulmonary Embolism Severity Index score >85) \n\n presence of hypoxemia (arterial SO2 <90% measured by pulse oximetry or an paO2 on room air of <60 mm Hg measured by blood gas analysis) \n\n systolic blood pressure of <100 mm Hg \n\n chest pain necessitating parenteral opioid administration \n\n active bleeding or at high-risk of major bleeding (stroke during the preceding 10 days, gastrointestinal bleeding during the preceding 14 days, or platelets <75,000 per mm3) \n\n renal failure (creatinine clearance of <30 ml/minute based on the Cockcroft-Gault formula) \n\n body mass >150 kg \n\n history of HIT or allergy to heparins \n\n therapeutic oral anticoagulation (INR \u22652)at the time of pulmonary embolism diagnosis \n\n potential barriers to treatment adherence or follow-up (alcoholism, illicit current or recent drug use, psychosis, dementia, homelessness, lack of telephone access, transportation time to nearest ED >45 minutes) \n\n known pregnancy \n\n imprisonment \n\n diagnosis of pulmonary embolism >23 hours ago \n\n refusal or inability to provide informed consent \n\n prior enrollment in the study", - "brief_summary": "The purpose of this randomized clinical trial is to determine whether outpatient treatment is as effective and safe as inpatient treatment among low-risk patients with pulmonary embolism.", - "NCTID": "NCT00425542" - }, - { - "brief_title": "Age-adjusted D-dimer Cut-off to Rule Out Pulmonary Embolism in the Emergency Department : A Real Life Impact Study", - "phase": "", - "drugs": "['No intervention']", - "drugs_list": [ - "No intervention" - ], - "diseases": "['Pulmonary Embolism']", - "diseases_list": [ - "Pulmonary Embolism" - ], - "enrollment": "1507.0", - "inclusion_criteria": "inclusion criteria: \n\n Consecutive out patients with suspected PE in whom PE has been considered ruled out by negative D-dimers using an age-adjusted cut-off. \n\n ", - "exclusion_criteria": ": \n\n Life expectancy less than 3 months. \n\n Geographic inaccessibility for follow-up. \n\n Therapeutic anticoagulation for any indication. \n\n Pregnancy. \n\n Age less than 18.", - "brief_summary": "A multicentre multinational prospective management outcome study has recently proven the safety of a diagnostic strategy combining clinical probability assessment with an age-adjusted D-dimer cut-off, defined as a value of (age x 10) in patients > 50 years, for ruling out PE in outpatients, with a very low likelihood of subsequent symptomatic VTE. Moreover, this study showed that such a strategy increased the diagnostic yield of D-dimers, as it allowed ruling out PE without further investigation in a significantly higher proportion of patients than when using standard cut-off, particularly so in patients 75 years or older.~The objective of the present study is to confirm in a prospective cohort of real life patients the usefulness of the age-adjusted D-dimer cut-off to rule out PE in patients presenting to the emergency department with suspected PE.", - "NCTID": "NCT02601846" - }, - { - "brief_title": "A Simple Clinical Tool to Help Diagnose Pulmonary Embolism: Phase 1", - "phase": "", - "drugs": "['Augmented pulse oximetry using incentive spirometer.', 'Incentive spirometer.']", - "drugs_list": [ - "Augmented pulse oximetry using incentive spirometer.", - "Incentive spirometer." - ], - "diseases": "['Pulmonary Embolism']", - "diseases_list": [ - "Pulmonary Embolism" - ], - "enrollment": "1500.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years of age or greater. \n\n Agrees and able to participate in the study. \n\n Room air SpO2 (oxygen saturation) less than 92% and newly-diagnosed PE (or controls with no PE) based on CT angiogram result. \n\n ", - "exclusion_criteria": ": \n\n Clinical concern for instability. \n\n Systolic blood pressure less than 100 mm Hg. \n\n Heart rate \u2265140 beats per minute. \n\n Oxygen saturation less than 85% with more than 4 L supplemental oxygen. \n\n Unable to participate/comply with instructions for using the incentive spirometer. \n\n Patients from the Federal Medical Center in Rochester, Minnesota. \n\n Patients who do not speak English (due to the need for expediency). \n\n Patients will be under the care of the Emergency Department team who have the skills and resources to monitor and treat patients if they were to become unstable.", - "brief_summary": "The goal of this project is to determine if the change in oxygen saturation during deep inspiration (augmented pulse oximetry) can be used as a method to rule out pulmonary embolism (PE). The investigators propose to evaluate a simple, non-invasive clinical tool to help rule out PE. The investigators plan to measure the oxygen saturation of 40 consecutive patients with newly-diagnosed PE (within 60 minutes of diagnosis) and 80 matched controls who do not have a PE. Trained, blinded Respiratory Therapists or Study Coordinators will record each patient's oxygen saturation before, during, and after a 2-minute period of deep inspirations (vital capacity [the maximal amount of air that can be inhaled, measured in milliliters]) using an incentive spirometer. The investigators' central hypothesis is that persons with a PE will not respond to augmented pulse oximetry and will not significantly improve or normalize their oxygen saturation.", - "NCTID": "NCT01898637" - }, - { - "brief_title": "Evaluation of ST2 and IL-33 in Patients Presenting to the Emergency Department With Trouble Breathing", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Pulmonary Disease', 'Asthma', 'Pulmonary Embolism', 'Pneumonia', 'Pulmonary Hypertension']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease", - "Asthma", - "Pulmonary Embolism", - "Pneumonia", - "Pulmonary Hypertension" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Presenting to the Emergency Department with signs and symptoms of dyspnea (short of breath, tachypnea, hyperventilation, etc) within the last 24 hours \n\n Normal cardiac output as measured by noninvasive bioimpedance \n\n Greater than or equal to 18 years of age \n\n Patient or legal representative willing and able to provide informed consent and comply with study procedures \n\n ", - "exclusion_criteria": ": \n\n A history of congestive heart failure and a BNP > 500pg/mL (or NTproBNP > 900pg/mL) if obtained by the treating physician \n\n Treating physician suspects patient has new onset congestive heart failure \n\n ECG changes diagnostic of acute myocardial ischemia/infarction \n\n Ischemic chest pain within the prior 24 hours by history \n\n Obvious chest trauma", - "brief_summary": "Trouble breathing (dyspnea) is a nonspecific symptom associated with many diseases such as chronic obstructive pulmonary disease (lung disorder in which the flow of air to the lungs is blocked), asthma, pneumonia, pulmonary hypertension (high blood pressure in the lungs), congestive heart failure (fluid build-up in the lungs because the heart is not pumping normally) and pulmonary embolism (blood clot in the lungs). The purpose of this study is to test two blood markers called ST2 and IL-33. Blood markers are proteins or other compounds in your blood that physicians use to diagnose different diseases and to determine what the course of an illness will be. In preliminary research studies, ST2 and IL-33 have been elevated in patients with a wide variety of diseases where the lungs are the primary organs involved. This research study will further investigate the ability of ST2 and IL-33 to predict the severity of disease and the possible use of ST2 and IL-33 in the diagnosis of various lung diseases.", - "NCTID": "NCT00707811" - }, - { - "brief_title": "Low Dose Rt-PA for Acute Normotensive Pulmonary Embolism With RVD", - "phase": "Phase 4", - "drugs": "['Recombinant tissue plasminogen activator (rt-PA)', 'Low Molecular Weight Heparin']", - "drugs_list": [ - "Recombinant tissue plasminogen activator (rt-PA)", - "Low Molecular Weight Heparin" - ], - "diseases": "['Pulmonary Thromboembolisms', 'Pulmonary Embolism']", - "diseases_list": [ - "Pulmonary Thromboembolisms", - "Pulmonary Embolism" - ], - "enrollment": "460.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 y\u2264Age\u226475y \n\n Acute PE (first symptoms occurred 14 d or less before randomization) confirmed by lung scan, or a positive computed tomographic pulmonary angiogram, or a positive selective pulmonary angiogram \n\n Hemodynamic stability, diastolic pressure>90mmHg. \n\n RV dysfunction confirmed by echocardiography (\u22651 criterion), except left-side heart disease, congenital heart disease and mitral valve disease. \n\n Increase of the right ventricle showed presented with RV end-diastolic anteroposterior diameter >25 mm, Right/left ventricular end-diastolic diameter >1 (apical or subcostal 4-chamber view) or Right/left ventricular end-diastolic anteroposterior diameter >0.5 \n\n Hypokinesis of RV-free wall (range of motion less than 5 mm) \n\n Tricuspid regurgitation pressure >30mmHg \n\n ", - "exclusion_criteria": ": \n\n RV anterior wall thickness > 5mm confirmed by echocardiography \n\n Active internal bleeding and spontaneous intracranial hemorrhage in preceding 6 months \n\n Major surgery, organ biopsy or non-compressible punctures within 2 weeks \n\n Ischemic stroke occurred within 2 months \n\n Gastrointestinal bleeding within 10 days \n\n Severe trauma occurred within15 days \n\n Neurosurgery or eye surgery within 1 months \n\n Severe hypertension difficult to control (systolic blood pressure>180mmHg or diastolic blood pressure>110mmHg) \n\n Cardiopulmonary resuscitation \n\n Platelet count less than 100\u00d7109 / L \n\n Pregnancy, or within 2 week post partum \n\n Infective endocarditis; left atrial thrombus; aneurysm \n\n Serious liver and kidney dysfunction \n\n Diabetic hemorrhagic retinopathy \n\n Suffering with bleeding disorders \n\n Chronic thromboembolic pulmonary hypertension \n\n Moderate to severe chronic obstructive pulmonary disease (COPD).", - "brief_summary": "In selected patients with acute pulmonary embolism(PE), low dose (50mg/2h) recombinant tissue plasminogen activator (rt-PA) regimen had been reported to have less bleeding tendency than the FDA-approved rt-PA 100mg/2h regimen 100mg/2h regimen (3% vs.10%), it is worthwhile to reveal whether low dose rt-PA plus low molecular weight heparin (LMWH) can rapidly reverses RV pressure overload in PE, but not increase bleeding and other adverse events. The aim of the study is to compare thrombolytic treatment with LMWH in patients with acute normotensive PE with right ventricular dysfunction(RVD).", - "NCTID": "NCT01531829" - }, - { - "brief_title": "Evaluation of Rapid Emergency Echography for Acute Dyspnoea", - "phase": "", - "drugs": "['Echocardiography according to the READ method.']", - "drugs_list": [ - "Echocardiography according to the READ method." - ], - "diseases": "['Acute Dyspnea']", - "diseases_list": [ - "Acute Dyspnea" - ], - "enrollment": "500.0", - "inclusion_criteria": "inclusion criteria: \n\n Admission to the Emergency Department Age \u2265 75 years \n\n AND criteria of acute dyspnoea: \n\n Breathe rate \u2265 25 cycles/minute \n\n or PaO2 \u2264 70 mmHg \n\n or SpO2 \u2264 92% in room air \n\n or PacO2 \u2265 45 mmHg and pH \u2264 7.35 AND Electrocardiogram in sinus rhythm at admission \n\n ", - "exclusion_criteria": ": \n\n None", - "brief_summary": "Elderly people constitute the largest proportion of emergency room patients, representing 12% of all emergency room admissions. The need for diagnostic tests or therapeutic interventions is much greater in this patient population. Cardiovascular diseases and symptoms represent 12% of the causes for emergency room admission, and patients suffering from cardiovascular disease are those whose emergency room visit lasts longest.~The diagnostic approach in the emergency room in elderly patients admitted for acute dypsnoea is complex, and early identification of acute left-sided heart failure (ALSHF) is vital as it has an impact on prognosis. The clinical signs are difficult to interpret, and are non-specific, particularly at the acute phase and in elderly or obese patients. Indeed, some authors have reported up to 50% of diagnostic errors in elderly patients.~Measure of the blood concentration of a natriuretic peptide allows a quick diagnosis. However, peptides suffer from several limitations, particularly in situations that are often encountered in elderly patients, such as sepsis, renal failure, acute coronary syndrome, pulmonary embolism, chronic respiratory failure, atrial fibrillation and high body mass index. Diagnostic performance deteriorates with increasing age, and there is a significant increase in this grey-zone in patients aged \u226575 years. In critical situations in elderly patients, assessment of natriuretic peptides serve mainly to rule out a diagnosis of left heart failure.~Some authors have suggested using lung ultrasound in the initial work-up of acute respiratory failure, since some specific profiles are known to be related to the presence of interstitial oedema, reflecting impaired left heart function (e.g. presence of B lines). These studies were performed in the context of intensive or critical care, but data are sparse regarding the application of this approach in the emergency room.~The hypothesis is that the diagnostic accuracy of a targeted and quick echographic approach, namely the READ method (Rapid Echography for Acute Dyspnoea), comprising targeted lung ultrasound combined with isolated measure of transmitral flow, would be superior to that of NT-proBNP assessment for the diagnosis of ALSHF in elderly patients (\u226575 years) admitted to the emergency department.", - "NCTID": "NCT02531542" - }, - { - "brief_title": "PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)", - "phase": "Phase 3", - "drugs": "['LMWH (Fragmin, dalteparin)', 'Unfractionated Heparin']", - "drugs_list": [ - "LMWH (Fragmin", - "dalteparin)", - "Unfractionated Heparin" - ], - "diseases": "['Critical Illness', 'Deep Venous Thrombosis']", - "diseases_list": [ - "Critical Illness", - "Deep Venous Thrombosis" - ], - "enrollment": "3659.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient is >/= 18 years of age \n\n Actual body weight is >/= 45 kg \n\n Admission to ICU expected to be >/= 72 hours in duration \n\n ", - "exclusion_criteria": ": \n\n Neurosurgery within last 3 months \n\n Ischemic stroke within last 3 months \n\n Intracranial hemorrhage within last 3 months \n\n Systolic Blood Pressure >/= 180mm Hg, Diastolic Blood Pressure >/= 110mm Hg for >/= 12 hours requiring vasoactive drug infusion \n\n Major hemorrhage within last week unless definitively treated \n\n Coagulopathy as defined by INR >/= 2 times upper limit of normal [ULN], or PTT >/= 2 times ULN, at time of screening \n\n Thrombocytopenia defined as platelet count /= 3 doses of LMWH during this ICU admission) \n\n Lack of informed consent", - "brief_summary": "The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (Fragmin, dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal leg Deep Vein Thrombosis (DVT) diagnosed by compression ultrasound, and the secondary outcomes of Pulmonary Embolism (PE), bleeding, Heparin-Induced Thrombocytopenia (HIT), and objectively confirmed venous thrombosis at any site.", - "NCTID": "NCT00182143" - }, - { - "brief_title": "Education Bundle to Decrease Patient Refusal of VTE Prophylaxis", - "phase": "", - "drugs": "['Patient-centered education bundle']", - "drugs_list": [ - "Patient-centered education bundle" - ], - "diseases": "['Venous Thromboembolism', 'Deep Venous Thrombosis', 'Pulmonary Embolism']", - "diseases_list": [ - "Venous Thromboembolism", - "Deep Venous Thrombosis", - "Pulmonary Embolism" - ], - "enrollment": "19652.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients on the four trial floors who miss at least one dose of VTE prophylaxis will be included in the study. \n\n ", - "exclusion_criteria": ": \n\n N/A", - "brief_summary": "The investigators have recently developed a registry of missed doses of VTE prophylaxis that includes retrospective data on missed doses of VTE prophylaxis. To decrease rates of VTE prophylaxis refusal, the group has developed a patient-centered education bundle that will be delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting education materials include a 2-page education sheet and an educational video.~The investigators hypothesize that patient refusal of VTE prophylaxis is associated with significant knowledge gaps among patients regarding patients' risk of developing VTE and the benefits of VTE prophylaxis and that delivering an education bundle to patients that refuse VTE prophylaxis will improve compliance with VTE prophylaxis and decrease rates of VTE.", - "NCTID": "NCT02402881" - }, - { - "brief_title": "The Blood Saving Effect of Tranexamic Acid in Total Knee Arthroplasty With Rivaroxaban as Thromboprophylaxis", - "phase": "Phase 4", - "drugs": "['Tranexamic Acid 5%,5ml/amp (intraoperative)', 'Tranexamic Acid 5%,5ml/amp (3 hours after operation)', '0.9% Normal Saline (intraoperative)', '0.9% Normal Saline (3 hours after operation)', 'rivaroxaban (10mg)']", - "drugs_list": [ - "Tranexamic Acid 5%,5ml/amp (intraoperative)", - "Tranexamic Acid 5%,5ml/amp (3 hours after operation)", - "0.9% Normal Saline (intraoperative)", - "0.9% Normal Saline (3 hours after operation)", - "rivaroxaban (10mg)" - ], - "diseases": "['Osteoarthritis, Knee']", - "diseases_list": [ - "Osteoarthritis", - "Knee" - ], - "enrollment": "294.0", - "inclusion_criteria": "inclusion criteria: \n\n End-stage arthritis of the knee \n\n Failure of medical treatment or rehabilitation \n\n Hemoglobin > 10g/dl \n\n No use of non-steroid anti-inflammatory agent one week before operation \n\n ", - "exclusion_criteria": ": \n\n Preoperative Hemoglobin \u226610 g/dl \n\n History of infection or intraarticular fracture of the affective knee \n\n Renal function deficiency (GFR < 55 ml/min/1.73m2)which is relative contraindicated for venography \n\n Elevated liver enzyme, history of liver cirrhosis, impaired liver function and coagulopathy (including long-term use anticoagulant) \n\n History of deep vein thrombosis, ischemic heart disease or stroke", - "brief_summary": "The aim of this study was to conduct a prospective, randomized, double-blind study and assess the efficacy of and safety for thromboprophylaxis of rivaroxaban in total knee arthroplasty patients when tranexamic acid is used for bleeding prophylaxis.", - "NCTID": "NCT02458729" - }, - { - "brief_title": "Early Rehabilitation After Total Hip Replacement", - "phase": "", - "drugs": "['Supervised progressive resistance training', 'Control group']", - "drugs_list": [ - "Supervised progressive resistance training", - "Control group" - ], - "diseases": "['Osteoarthritis, Hip']", - "diseases_list": [ - "Osteoarthritis", - "Hip" - ], - "enrollment": "73.0", - "inclusion_criteria": "inclusion criteria: \n\n Total hip replacement for osteoarthrosis \n\n Living within 30 km from the hospital \n\n Motivated to attend training 2 times/week in 10 weeks \n\n Reduced functional ability measured as: HOOS score < 67 \n\n written informed consent \n\n ", - "exclusion_criteria": ": \n\n Comorbidities such as cancer, neuromuscular diseases, heart diseases etc. \n\n Cognitive impairment \n\n Body mass index > 35 \n\n Resurfacing prosthesis \n\n Scheduled additional prosthetic surgery in lower extremity within 6 months", - "brief_summary": "The purpose of this study is to determine whether supervised progressive resistance training is effective in the early phase after Total Hip Replacement. The investigators hypothesise that 10 weeks of supervised, progressive resistance training immediately after discharge will lead to increased functional performance, muscle strength and muscle power compared to standard rehabilitation consisting of home-based exercise.", - "NCTID": "NCT01214954" - }, - { - "brief_title": "Pain During Chest Tube Withdrawal: Evaluation Using Pan Monitor", - "phase": "", - "drugs": "['Chest drain withdrawal', 'Pain Monitor']", - "drugs_list": [ - "Chest drain withdrawal", - "Pain Monitor" - ], - "diseases": "['Chest Pain']", - "diseases_list": [ - "Chest Pain" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n patients undergoing removal of a chest tube after lung surgery, \n\n patients able to indicate the pain score. \n\n ", - "exclusion_criteria": ": \n\n pregnancy, lactation , \n\n insulin-dependent diabetes with dysautonomia, \n\n central or peripheral neurological disease, agitation, \n\n inability to understand the protocol, \n\n inability to use the Pain Monitor: skin abnormalities at the site of measurement, pacemaker or implantable defibrillator, condition affecting the sympathetic nervous system, tremor of the extremities, \n\n contra-indication to oral morphine , \n\n respiratory failure, severe hepatic insufficiency, intracranial hypertension, epilepsy associations \n\n recent administration of neostigmine or of atropine.", - "brief_summary": "Pain evaluation remains a clinical problem. Pain Monitor allows pain evaluation using the measurement of skin conductance.~Withdrawal of chest tube can be painful and the purpose of the study was to compare auto-evaluation of pain (visual analogic scale) and the index measured by the Pain Monitor.", - "NCTID": "NCT02015858" - }, - { - "brief_title": "Glucose Metabolism Disorders and Metabolic Syndrome Before and After Primary Hip and Knee Replacement", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Hyperglycemia', 'Hypercholesterolemia', 'Persistent Postoperative Pain', 'Hip Replacement', 'Knee Replacement']", - "diseases_list": [ - "Hyperglycemia", - "Hypercholesterolemia", - "Persistent Postoperative Pain", - "Hip Replacement", - "Knee Replacement" - ], - "enrollment": "155.0", - "inclusion_criteria": "inclusion criteria: \n\n Primary hip and knee replacement for osteoarthritis \n\n Enrolled previously into study NCT01021826 \n\n ", - "exclusion_criteria": ": \n\n Arthritis other than osteoarthritis (based on study NCT01021826) \n\n Medication affecting glucose metabolism (excl. antidiabetic agents) (based on study NTC01021826) \n\n Died before follow-up phase \n\n Did not undergo the planned hip or knee replacement", - "brief_summary": "Osteoarthritis patients undergoing primary hip and knee replacement are followed-up and changes in their glucose metabolism and other metabolic parameters (obesity, cholesterol levels) are examined. Persistent postoperative pain is examined as secondary outcome.", - "NCTID": "NCT01743313" - }, - { - "brief_title": "Cost of Monitoring Patients Treated With Vitamin K Antagonists in Spain", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Anticoagulation']", - "diseases_list": [ - "Anticoagulation" - ], - "enrollment": "1144.0", - "inclusion_criteria": "For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com \n\n inclusion criteria: \n\n Patients aged 18 or older over the study period \n\n Patients with a diagnosis for NVAF or VTE anytime in their medical records \n\n Patients having at least one year of enrolment in the database prior to the index date \n\n Patients newly initiated with VKA during the study period (index date) \n\n ", - "exclusion_criteria": ": \n\n Patients with a diagnosis for both NVAF and VTE anytime in their medical records", - "brief_summary": "To estimate annualized total cost rates (i.e. direct medical costs from hospitalizations, consultations, medications, and tests) of adequately controlling a patient (i.e. INR between 2-3 and TTR\u2265 60%) diagnosed with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE), and treated with vitamin K antagonists (VKA) in Spain.", - "NCTID": "NCT02427516" - } - ], - "2": [ - { - "brief_title": "PERC Rule to Exclude Pulmonary Embolism in the Emergency Deparment", - "phase": "", - "drugs": "['PERC based Strategy']", - "drugs_list": [ - "PERC based Strategy" - ], - "diseases": "['Emergency Patients']", - "diseases_list": [ - "Emergency Patients" - ], - "enrollment": "1922.0", - "inclusion_criteria": "inclusion criteria: \n\n Acute onset of, or worsening of dyspnea Or chest pain \n\n Low clinical pretest probability of PE, empiricially estimated by the gestalt. \n\n ", - "exclusion_criteria": ": \n\n Other obvious cause than PE for dyspnea or chest pain \n\n Acute severe presentation \n\n Contra-indication to CTPA \n\n Concurrent anticoagulation treatment \n\n Current diagnosed thrombo-embolic event \n\n Inability to follow up \n\n Prisoners \n\n Pregnancy \n\n No social security \n\n Participation in another intervention trial", - "brief_summary": "The Pulmonary Embolism Rule Out Criteria (PERC) is an 8-item rule, that was derived and tested to rule out the diagnosis of Pulmonary Embolism (PE) in the Emergency Department (ED) amongst low risk patients. Even though meta analyses have confirmed the safety of its utilization, equipoise remains - especially in European country where the prevalence of PE is higher than in the US- on whether this rule could be safely applied to all low risk emergency patients with a suspicion of PE.~The PROPER Trial is a non inferiority , cluster randomized trial. All centers will recruit patients with a suspicion of PE and a low pre test probability. To rule out the diagnosis of PE, center will use the usual diagnostic strategies with D-dimeres measurement for 6 months, and PERC based strategy for 6 months.~In the control group (usual strategy), patients will be tested for D-dimeres, followed if positive by a Computed Tomography of Pulmonary Artery (CTPA).~In the intervention group (PERC Based), patients will be first assessed with PERC score. If PERC=0, then the diagnosis of PE will be exclude with no supplemental investigations. If PERC>0, then patients will undergo the usual strategy, with D-dimeres measurement +/- CTPA.~The primary outcome is the failure percentage of the diagnostic strategy, defined as diagnosed deep venous thrombosis (DVT) or PE at 3 month follow up, among patients for whom PE has been initially ruled out.", - "NCTID": "NCT02375919" - }, - { - "brief_title": "Strategies for Suspected Pulmonary Embolism in Emergency Departments", - "phase": "", - "drugs": "['Computer-Assisted diagnostic Decision Support', 'written diagnostic guidelines', 'electronic therapeutic reminders']", - "drugs_list": [ - "Computer-Assisted diagnostic Decision Support", - "written diagnostic guidelines", - "electronic therapeutic reminders" - ], - "diseases": "['Quality of Health Care', 'Pulmonary Embolism']", - "diseases_list": [ - "Quality of Health Care", - "Pulmonary Embolism" - ], - "enrollment": "1331.0", - "inclusion_criteria": "inclusion criteria: \n\n patient with suspected pulmonary embolism \n\n prescription of a specific paraclinical diagnostic investigation or start of a specific treatment for pulmonary embolism \n\n ", - "exclusion_criteria": ": \n\n confirmation or exclusion of pulmonary embolism before admission in emergency department \n\n confirmation of deep venous thrombosis before admission in emergency department \n\n suspicion of pulmonary embolism during hospitalization (in-patient) \n\n suspicion of pulmonary embolism without investigation realization \n\n patient already included in the study \n\n patient refusing the utilization of his data for the study", - "brief_summary": "Aims: 1) To evaluate the effectiveness of two interventions aimed at improving the management of patients with suspected pulmonary embolism: Written guidelines and Computer-Assisted Decision Support (CADS). 2) To evaluate the impact of electronic reminders on the appropriateness of the treatment of patients with suspected PE~Design: Pragmatic, unblinded, cluster randomised controlled study.~Setting: 20 French Emergency Departments~Patients: Out patients suspected of having pulmonary embolism~Methods: Emergency physicians will prospectively complete a standardized electronic form on Personal Data Assistant (PDA), including patients' characteristics, the clinical probability if assessed, the diagnostic tests performed, the treatments initiated and the final diagnostic and therapeutic decisions. Patients will be interviewed at the end of a 3-month follow-up period using a standardized questionnaire.~The reference rate of appropriateness of the diagnostic management before intervention will be assessed in each centre. At the end of this preliminary period, the centres will be randomized in two fold two groups according to a factorial design with stratification on their reference level of appropriateness. Half of the centres will have written guidelines and half a Computer-Assisted Decision Support for the diagnosis of PE on the PDA. In each of these two main groups, half of the centres will have electronic reminders on their PDA concerning the treatment of PE.~Judgment criteria~Main : Rate of strategies considered as validated according to the results of the systematic review and meta-analysis.3~Secondary judgment criteria (diagnosis):~Rate of strategies considered as validated or acceptable according to the opinion of international advisors.~Rate of thromboembolic-events during a 3-month follow-up period in patients for whom pulmonary embolism will be ruled out~Costs of the diagnostic management~Secondary judgment criteria (treatment):~Delay between Emergency Department admission and the first dose of antithrombotic treatment in patients with high clinical probability of PE according to the Revised Geneva Score~Rate of inappropriate treatment according to international recommendations for patients with confirmed PE.~Number of patients: By estimating that the rate of appropriateness would be 55% in the written guidelines group, 1331 patients are necessary to highlight an absolute superiority of 15% in the CADS group (rate of conformity of 70%).~The number of patients will be adjusted at the end of the preliminary period according to the level of appropriateness before interventions considering that it will improve less than 5% in the written guidelines group.", - "NCTID": "NCT00188032" - }, - { - "brief_title": "Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: PERFECT", - "phase": "", - "drugs": "['Catheter directed debulking of Pulmonary Embolus']", - "drugs_list": [ - "Catheter directed debulking of Pulmonary Embolus" - ], - "diseases": "['Pulmonary Embolism']", - "diseases_list": [ - "Pulmonary Embolism" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Must be Age greater than or equal to 18 \n\n Obtain informed written consent. \n\n Diagnosed with acute pulmonary embolism (PE) (< 14 days) \n\n Catheter-directed therapy (CDT) was performed to treat acute PE", - "exclusion_criteria": "", - "brief_summary": "A prospective observational study to evaluate the safety and effectiveness data of catheter-directed therapy (CDT) including percutaneous mechanical thrombectomy (PMT) for treatment of acute pulmonary embolism (PE)", - "NCTID": "NCT01097928" - }, - { - "brief_title": "Accuracy of Multi-organ Ultrasound for the Diagnosis of Pulmonary Embolism", - "phase": "", - "drugs": "['Ultrasound scan']", - "drugs_list": [ - "Ultrasound scan" - ], - "diseases": "['Pulmonary Embolism']", - "diseases_list": [ - "Pulmonary Embolism" - ], - "enrollment": "357.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with clinical suspected pulmonary embolism \n\n Simplified Well's score>4 (PE likely) or D-dimer value \u2265500ng/ml \n\n Patients that undergo MCTPA in the Emergency Department for suspected pulmonary embolism \n\n ", - "exclusion_criteria": ": \n\n Refused consent \n\n Less than 18 years old \n\n Not possible to perform ultrasound scan within 3 hours before MCTPA", - "brief_summary": "Patients with suspected Pulmonary Embolism (PE) and a high clinical probability or a high D-dimer level should undergo a second level diagnostic test such as Multidetector Computed Tomography Angiography (MCTPA). Unfortunately MCTPA involves radiation exposure, is expensive, is not feasible in unstable patients and has contraindications. UltraSound (US) is safe and rapidly available even in unstable patients. Many authors evaluated the diagnostic role of Compression Ultrasound Scan (CUS) for detecting limbs Deep Vein Thrombosis (DVT), TransThoracic Echocardiography (TTE) for detecting Right Ventricular Dysfunction (RVD) or Thoracic UltraSound (TUS) for detecting subpleural infarcts in patients with suspected PE. No previous studies have investigated the diagnostic accuracy of CUS, TTE and TUS combined (multiorgan US) for the diagnosis of PE. This study evaluates the diagnostic accuracy of multiorgan US.~Methods. Consecutive patients that underwent MCTPA in the Emergency Department for clinical suspicion of PE and with a simplified Well's score>4 (PE likely) or with a D-dimer value \u2265500ng/ml were enrolled in the study. MCTPA was considered the gold standard for PE diagnosis. A multiorgan US was performed by an emergency physician sonographer before MCTPA. PE was considered echographically present if CUS was positive for DVT or TTE was positive for RVD or at least one pulmonary subpleural infarct was detected with TUS. The accuracy of the single and multiorgan US was calculated.", - "NCTID": "NCT01635257" - }, - { - "brief_title": "Special Drug Use Investigation of Xarelto for Venous Thromboembolism (VTE)", - "phase": "", - "drugs": "['Rivaroxaban (Xarelto, BAY59-7939)']", - "drugs_list": [ - "Rivaroxaban (Xarelto", - "BAY59-7939)" - ], - "diseases": "['Venous Thromboembolism']", - "diseases_list": [ - "Venous Thromboembolism" - ], - "enrollment": "2540.0", - "inclusion_criteria": "inclusion criteria: \n\n - Patients who start rivaroxaban for VTE(pulmonary embolism, deep vein thrombosis) anticoagulation therapy. \n\n ", - "exclusion_criteria": ": \n\n - Patients who are contraindicated based on the product label and have already received Xarelto treatment.", - "brief_summary": "The objective of this investigation is to assess safety and effectiveness of Xarelto under practice routine use in VTE secondary prevention after acute DVT, focusing on hemorrhagic-related AEs, recurrent venous thromboembolism (PE/DVT), all-cause mortality. This study is a company sponsored, one- arm prospective cohort study with patients to whom Rivaroxaban treatment for VTE (PE/DVT) has been chosen. The study includes a standard observation period (1 year) and an extension survey period (2 years, at the longest).", - "NCTID": "NCT02558465" - }, - { - "brief_title": "VERITAS: An Evaluation of the Veniti Vidi Retrievable Inferior Vena Cava Filter System in Patients at Risk for Pulmonary Embolism", - "phase": "", - "drugs": "['Veniti Inferior Vena Cava Filter']", - "drugs_list": [ - "Veniti Inferior Vena Cava Filter" - ], - "diseases": "['Deep Vein Thrombosis', 'Pulmonary Embolus']", - "diseases_list": [ - "Deep Vein Thrombosis", - "Pulmonary Embolus" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n \u2265 18 years \n\n Investigator judges caval filtration clinically indicated for prevention of pulmonary embolism in patient with venous thromboembolic disease or at high risk for venous thromboembolic disease. Patient must meet at least one of the following: \n\n Anticoagulant therapy is contraindicated, has failed, cannot be achieved or maintained, must be interrupted, resulted in complication, or places the patient at high risk of complication and the patient has: \n\n Pulmonary embolus \n\n Iliocaval deep vein thrombosis (DVT) \n\n Severe trauma with high risk of venous thromboembolism including closed head injury, spinal cord injury, or multiple long bone or pelvic fractures \n\n Surgery planned with high risk of venous thromboembolism including procedures such as bariatric, orthopedic, or pelvic surgery \n\n Past history of thromboembolic disease undergoing surgery \n\n Therapeutic anticoagulation can be achieved, but the patient has: \n\n Venous thromboembolism such as pulmonary embolism or DVT with limited cardiopulmonary reserve \n\n Massive pulmonary embolism already treated with thrombectomy or any thrombolytic therapy \n\n Chronic pulmonary embolism already treated with thrombectomy \n\n Large, free floating proximal, e.g., iliofemoral or iliocaval, DVT \n\n Iliocaval DVT with planned catheter thrombectomy or thrombolysis treatment OR \n\n Medical condition with high risk of venous thromboembolism \n\n ", - "exclusion_criteria": ": \n\n Condition that inhibits radiographic visualization of the IVC \n\n Known inadequate venous anatomy to allow insertion or retrieval of the filter from the IVC including occlusion of the SVC or jugular veins \n\n Known IVC transverse diameter at target implant site > 28 mm \n\n Known obstructing abdominal mass or anatomy that is not suitable for infra-renal placement of IVC filter \n\n Known duplication of IVC or left-sided IVC \n\n Severe kyphosis or scoliosis \n\n Known IVC thrombosis extending to renal veins, or renal or gonadal vein thrombosis \n\n Risk for septic pulmonary embolism \n\n Confirmed bacteremia \n\n Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min, or dialysis dependent. \n\n Contrast agent allergy that cannot be adequately pre-medicated \n\n Known hypersensitivity to Nitinol (nickel-titanium), platinum, Polyether ether ketone (PEEK), UV Cure Adhesive or Cyanoacrylate Adhesive \n\n Uncontrolled or active coagulopathy or known uncorrectable bleeding diathesis \n\n Life expectance < 6 months \n\n Female of childbearing potential who is pregnant or plans to become pregnant during the duration of the clinical study. (If a female of child bearing potential wishes to participate, she must have negative pregnancy test within 48 hours of the implantation and any retrieval procedures.) \n\n Has filter in place or underwent filter retrieval in previous 60 days \n\n Simultaneously participating in another therapeutic drug or device clinical trial or has participated in such trial in the 30 days prior to enrollment \n\n Investigator considers patient to be a poor candidate for the study or that including the patient may compromise the study, e.g., suspect patient may not comply with follow up procedures, concomitant conditions \n\n Patient does not wish to consent to study or comply with study procedures, including possible 2 year follow up", - "brief_summary": "This is a prospective, multicenter single arm, nonrandomized study that will include 150 patients at a maximum of 20 investigational sites. It is estimated that it may take 13 months to complete enrollment. Follow-up will continue through 24 months post-implant or one month post-retrieval, whichever occurs first. It is required that filters be retrieved from at least 50 patients and the filter is permanent in at least 50 patients.", - "NCTID": "NCT01787773" - }, - { - "brief_title": "Low Molecular Weight Heparin for 72 Hours Followed by Dabigatran for Acute Intermediate-Risk Pulmonary Embolism.", - "phase": "Phase 4", - "drugs": "['Dabigatran']", - "drugs_list": [ - "Dabigatran" - ], - "diseases": "['Pulmonary Embolism']", - "diseases_list": [ - "Pulmonary Embolism" - ], - "enrollment": "400.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u226518 years \n\n Objectively confirmed diagnosis of acute PE by multidetector CT angiography, ventilation/perfusion lung scan, or selective invasive pulmonary angiography, according to established diagnostic criteria, with or without symptomatic deep vein thrombosis \n\n Absence of hemodynamic collapse, or decompensation, at presentation; Hemodynamic collapse or decompensation \n\n Intermediate-risk category of PE severity indicated by a positive (score \u22651) simplified pulmonary embolism severity index (sPESI), in combination with the presence of at least one of the following criteria at presentation: \n\n At least one sign of RV pressure overload/dysfunction on CT angiography or echocardiography \n\n Signs of myocardial injury as indicated by elevated troponin levels \n\n Signs of (RV) failure as indicated by NT-proBNP levels >600 pg/ml at baseline. \n\n Ability of the subject to understand the character and individual consequences of the clinical trial; signed and dated informed consent of the subject available before the start of any specific trial procedures \n\n ", - "exclusion_criteria": ": \n\n Pregnancy (a negative serum or urine pregnancy test should be available for women of child-bearing potential before study inclusion) or lactation \n\n Women of childbearing potential who do not practice a medically accepted highly effective contraception during the trial and one month beyond \n\n History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product \n\n Participation in another clinical trial during the present clinical trial or within the last three months \n\n Medical or psychological condition that would not permit completion of the trial or signing of informed consent \n\n Use of a fibrinolytic agent, surgical thrombectomy, interventional (catheter-directed) thrombus aspiration or lysis, or use of a cava filter to treat the index episode of PE \n\n Treatment with any therapeutically dosed anticoagulant for more than 48 hours prior to enrolment \n\n Need for long-term treatment with a low molecular weight heparin, vitamin K antagonists or NOAC, for an indication other than the index PE episode, or for antiplatelet agents except acetylsalicylic acid at a dosage \u2264100 mg/day; \n\n Active bleeding or known significant bleeding risk (e.g., gastrointestinal ulcer, malignant neoplasms, injuries or recent surgeries of the brain, spinal cord or eyes, recent intracranial bleedings, known or suspected esophagus varices, aneurysms or intraspinal or intracranial vascular abnormalities) \n\n Artificial heart valves requiring treatment with an anticoagulant \n\n Renal insufficiency with estimated creatinine clearance <30 ml/min/1.73m2 \n\n Chronic liver disease with aminotransferase levels two times or more above the local upper limit of normal range \n\n Concomitant administration of strong inhibitors of P-glycoprotein like ketoconazole, cyclosporin, itraconazole or dronedarone \n\n Unwillingness or inability to adhere to treatment or to the follow-up visits \n\n Life expectancy less than 6 months", - "brief_summary": "This prospective, multicenter, multinational, phase IV, interventional single-armed (management) trial will focus on the safety, efficacy and cost-effectiveness of a new oral anticoagulant in the treatment of patients with acute intermediate-risk PE based on validated imaging (echocardiographic or CT angiographic) and laboratory biomarker (circulating levels of cardiac troponins and natriuretic peptides) parameters and their combinations.", - "NCTID": "NCT02596555" - }, - { - "brief_title": "Follow-up in Rivaroxaban Patients in Setting of Thromboembolism", - "phase": "", - "drugs": "['Non-interventional study']", - "drugs_list": [ - "Non-interventional study" - ], - "diseases": "['Venous Thromboembolism']", - "diseases_list": [ - "Venous Thromboembolism" - ], - "enrollment": "1343.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients aged 18 years or older with an objectively verified diagnosis of DVT and/or PE and treated according to routine clinical practice with Rivaroxaban \n\n ", - "exclusion_criteria": ": \n\n Patients in whom follow-up is unlikely or impossible \n\n Patients unable to give consent \n\n Patients who receive heparin therapy for more than 48 hours \n\n Patients who receive more than one dose of warfarin \n\n Patients with an indication for anticoagulation other than DVT and/or PE \n\n All contraindications listed in the local product information (SmPC) will form part of the ", - "brief_summary": "In patients with acute clots (deep vein thrombosis or pulmonary embolism) the investigators will collect real world data on their short and long term outcomes. The investigators hypothesise that in patients treated from the outset with rivaroxaban that: 1. treatment will be non-inferior to treatment with conventional anticoagulants (heparins and warfarin); 2. there will be less bleeding than when patients are on conventional anticoagulants; 3. there will be a lower long-term incidence of morbidity from chronic thromboembolic pulmonary hypertension and post-thrombotic limb syndrome.", - "NCTID": "NCT02248610" - }, - { - "brief_title": "Prognostic Value of Heart-type Fatty Acid-Binding Protein (h-FABP) in Acute Pulmonary Embolism", - "phase": "", - "drugs": "[\"Dosage de l'h-FABP\"]", - "drugs_list": [ - "Dosage de l'h-FABP" - ], - "diseases": "['Pulmonary Embolism']", - "diseases_list": [ - "Pulmonary Embolism" - ], - "enrollment": "165.0", - "inclusion_criteria": "inclusion criteria: \n\n patients with acute pulmonary embolism diagnosed in the emergency departement \n\n ", - "exclusion_criteria": ": \n\n patient under guardianship \n\n patient without social insurance \n\n pregnant women \n\n refusal to sign the consent \n\n myocardial infarction in the 10 days before pulmonary embolism", - "brief_summary": "The patients presenting with acute pulmonary embolism and right ventricular dysfunction are at high risk for life-threatening events and must be identified in the emergency department for adequate care and hospital admission. Echocardiography can identify right ventricular dysfunction, but this test is not always available, and echocardiographic criteria of right ventricular dysfunction vary among published studies. The primary purpose of this protocol is to study the prognostic value of a cardiac biomarker, h-FABP (heart-type Fatty Acid-Binding Protein) , to identify in the emergency department the patients presenting with high risk pulmonary embolism. As secondary outcomes, H-FABP results will be compared to other cardiac biomarkers (BNP, troponin) and clinical score performances that have been previously studied to stratify the prognosis of patients with pulmonary embolism in the emergency department.", - "NCTID": "NCT01326507" - }, - { - "brief_title": "D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months", - "phase": "", - "drugs": "['Discontinue anticoagulant therapy (Negative d-dimer)', 'Continue on anticoagulant therapy (positive d-dimer)']", - "drugs_list": [ - "Discontinue anticoagulant therapy (Negative d-dimer)", - "Continue on anticoagulant therapy (positive d-dimer)" - ], - "diseases": "['Deep Vein Thrombosis', 'Pulmonary Embolism']", - "diseases_list": [ - "Deep Vein Thrombosis", - "Pulmonary Embolism" - ], - "enrollment": "410.0", - "inclusion_criteria": "inclusion criteria: \n\n Be >= 18 years of age \n\n Have had ONE episode of unprovoked proximal DVT and/or PE \n\n Have completed 3 uninterrupted months of warfarin therapy (target INR of 2.0-3.0) \n\n ", - "exclusion_criteria": ": \n\n Another indication for long-term anticoagulation (e.g., atrial fibrillation) \n\n A high risk of bleeding as evidenced by any of the following: \n\n Age greater than 75 years \n\n Previous episode of major bleeding where the cause was not effectively treated \n\n Known chronic thrombocytopenia with a platelet count of less than 120,000 x 10^9 /L \n\n Known chronic renal impairment with a creatinine of more than 150 mumols /litre (1.7 mg/dl) \n\n Known chronic liver disease with a total bilirubin of more than 25 mumols /litre (1.5 mg/dl) \n\n Active peptic ulcer disease \n\n Poor compliance with, or control of, anticoagulant therapy during initial treatment \n\n Requires dual antiplatelet therapy (e.g. aspirin and clopidogrel) \n\n A vena caval filter \n\n Has had D-dimer testing performed within 2 months of potential enrollment other than for evaluation of suspected recurrent VTE that was not confirmed \n\n Has a life expectancy less than 5 years \n\n Is unable to attend follow-up visits because of geographic inaccessibility \n\n Is participating in a competing clinical investigation", - "brief_summary": "The purpose of this study is to determine if the risk of recurrent venous thromboembolism (VTE) after stopping therapy is low and acceptable in patients with a first unprovoked proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) who have completed 3 months of therapy and who have a negative D-dimer test on therapy and 1 month after stopping therapy.", - "NCTID": "NCT00720915" - }, - { - "brief_title": "Inter-Observer Reliability and Accuracy of Tricuspid Annular Plane Systolic Excursion in Patients With Suspected PE in the ED", - "phase": "", - "drugs": "['Echocardiogram']", - "drugs_list": [ - "Echocardiogram" - ], - "diseases": "['Pulmonary Embolism']", - "diseases_list": [ - "Pulmonary Embolism" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Concern for PE by attending physician and CTPA ordered \n\n ", - "exclusion_criteria": ": \n\n If patient is under the age of 18, a prisoner, or a ward of the state \n\n CTPA ordered but not performed", - "brief_summary": "The purpose of this study will be to evaluate the measurement of tricuspid annular plane systolic excursion (TAPSE) by emergency physician performed echocardiogram on patients with suspected pulmonary embolism (PE) who are scheduled to get a computed tomography of the pulmonary arteries (CTPA)", - "NCTID": "NCT02356120" - }, - { - "brief_title": "Clinical Decision Rule Validation Study to Predict Low Recurrent Risk in Patients With Unprovoked Venous Thromboembolism", - "phase": "Phase 4", - "drugs": "['Application of theMen continue and HER DOO2 rule']", - "drugs_list": [ - "Application of theMen continue and HER DOO2 rule" - ], - "diseases": "['Idiopathic Venous Thromboembolism']", - "diseases_list": [ - "Idiopathic Venous Thromboembolism" - ], - "enrollment": "2779.0", - "inclusion_criteria": "inclusion criteria: \n\n First episode of major unprovoked VTE \n\n VTE objectively proven \n\n VTE treated for 5-12 months with anticoagulant therapy authorized for the REVERSE II study (initial or ongoing therapy) \n\n Absence of recurrent VTE during the treatment period \n\n ", - "exclusion_criteria": ": \n\n Less than 18 years of age \n\n Patients who have already discontinued anticoagulant therapy \n\n Patients requiring ongoing anticoagulation for reasons other than VTE \n\n Being treated for a recurrent unprovoked VTE \n\n Patients with high risk thrombophilia \n\n patients who plan on using exogenous estrogen(OCP,HRT)if anticoagulant therapy is discontinued \n\n Patients with pregnancy associated VTE \n\n Geographically inaccessible for follow-up \n\n Patients unable or unwilling to provide informed consent", - "brief_summary": "The main objective of this study is to verify whether a new clinical decision rule identifying patients diagnosed with unprovoked blood clots who have a low risk of recurrence can safely stop oral anticoagulant therapy after 5-7 months of treatment.", - "NCTID": "NCT00967304" - }, - { - "brief_title": "Canadian Outpatient VTE Management Registry", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Medical Prevention Therapy']", - "diseases_list": [ - "Medical Prevention Therapy" - ], - "enrollment": "915.0", - "inclusion_criteria": "inclusion criteria: \n\n Objectively confirmed VTE \n\n Initiation of enoxaparin treatment within Day 0-10 after diagnosis of VTE: \n\n Outpatients who will be treated with enoxaparin + VKA in combination are permitted to receive initial treatment other than enoxaparin for a maximum of 48 hours or 2 treatment doses preceding entry into the study \n\n Outpatients on enoxaparin monotherapy are permitted to receive up to 10 days of treatment other than enoxaparin preceding entry into the study. \n\n ", - "exclusion_criteria": ": \n\n - Medical or psychiatric disorders associated with altered cognition or mentation that precludes understanding of the informed consent process. \n\n The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.", - "brief_summary": "Primary Objective:~- To obtain prospective, clinical practice-based data on how symptomatic VTE is managed with low molecular weight heparin (LMWH) enoxaparin in Canadian outpatient settings.~Secondary Objective:~To describe the demographic and clinical characteristics of patients with symptomatic VTE including characteristics of VTE, VTE risk factors and bleeding risk factors.~To assess the frequency of patient characteristics that would necessitate adjustment in the dose or duration of enoxaparin therapy, e.g. high BMI, impaired creatinine clearance, advanced age, cancer-associated VTE.~To assess the degree of adherence in clinical practice to Consensus Guidelines (ACCP/American College of chest Physician 2008) for the management of acute VTE, vis a vis:~Appropriate dosing of enoxaparin~Recommended duration of initial LMWH therapy~Adequate overlap of LMWH with vitamin K antagonists (VKA)~Recommended duration of longterm VKA~Frequency of use of LMWH monotherapy to treat cancer-related VTE~To access safety outcomes (including bleeding and recurrent VTE)~To describe the utilization of resources due to bleeding and recurrent VTE during the treatment period.", - "NCTID": "NCT01133002" - }, - { - "brief_title": "Efficacy of Low (30ml) Versus Full Dose (100ml) Contrast CT Pulmonary Angiography in Detecting Emboli", - "phase": "", - "drugs": "['Low-Dose IV Contrast', 'Siemens Sensation 64-MDCT scanner.', 'Visipaque 320 non-ionic isoosmolar contrast agent']", - "drugs_list": [ - "Low-Dose IV Contrast", - "Siemens Sensation 64-MDCT scanner.", - "Visipaque 320 non-ionic isoosmolar contrast agent" - ], - "diseases": "['Multiple Pulmonary Emboli']", - "diseases_list": [ - "Multiple Pulmonary Emboli" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients referred for CT pulmonary angiogram to exclude pulmonary embolus \n\n ", - "exclusion_criteria": ": \n\n Class 3 or 4 Congestive Heart Failure \n\n Supraventricular tachycardia \n\n History of contrast allergy \n\n Unable to give informed consent \n\n Patients with serum creatinine >1.28 mg/dl without referring physician approval", - "brief_summary": "With the improvement in CT scanners and injectors, diagnostic chest CT can now be performed in less than 10 seconds. It was hypothesized that diagnostic CT pulmonary angiograms could be done with less than the usual 80-120 ml of contrast used. We have developed a method of performing diagnostic CT pulmonary angiograms with 30 ml of intravenous contrast in most patients. The long-term objective of this study is to show that there is no difference in the diagnostic efficacy of this low dose 30 ml technique when compared to the more traditional full-dose technique.", - "NCTID": "NCT01935141" - }, - { - "brief_title": "Eliquis (VTE Treatment and Prevention of Recurrent VTE) rPMS", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Venous Thromboembolism']", - "diseases_list": [ - "Venous Thromboembolism" - ], - "enrollment": "29.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult (\u226519 years of age) patients who are initiating treatment with Eliquis for the treatment of VTE or prevention of recurrent VTE for the first time in accordance with the Korean package insert will be enrolled in the study \n\n ", - "exclusion_criteria": ": \n\n Patients with prior treatment with Eliquis before enrollment in this study \n\n Patients receiving Eliquis treatment for an indication not approved indication in Korea \n\n Patients meeting any of the following criteria will not be included in the study: \n\n i) Hypersensitivity to the active substance or to any of the excipients \n\n ii) Clinically significant active bleeding \n\n iii) Hepatic disease associated with coagulopathy and clinically relevant bleeding risk \n\n iv) Patients with increased bleeding risk due to such as following diseases: \n\n Recent gastrointestinal ulceration history \n\n Recent intracranial or intracerebral haemorrhage history \n\n Intraspinal or intracerebral vascular abnormalities \n\n Recent brain, spinal or ophthalmic surgery history \n\n Recent brain or spinal injury \n\n Known or suspected oesophageal varices \n\n Arteriovenous malformations \n\n Vascular aneurysms \n\n Patients with malignant neoplasms at high risk of bleeding \n\n Concomitant treatment with any other anticoagulant agent: \n\n i) Unfractionated heparin (UFH) \n\n ii) Low molecular weight heparins (enoxaparin, dalteparin, etc) \n\n iii) Heparin derivatives (fondaparinux, etc) \n\n iv) oral anticoagulants (warfarin, rivaroxaban, dabigatran, etc) except under the circumstances of switching therapy to or from apixaban or when UFH is given at doses necessary to maintain a patent central venous or arterial catheter \n\n Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption", - "brief_summary": "To assess the real-world safety/effectiveness of Eliquis in Korean venous thromboembolism (VTE) patients and patient characteristics that are associated with bleeding among patients taking Eliquis. To identify factors that might be associated with the safety and effectiveness profile in Korean VTE patients.", - "NCTID": "NCT02546817" - } - ] - }, - { - "patient_id": "sigir-20154", - "patient": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", - "0": [ - { - "brief_title": "ProspEctive First Evaluation in Chest Pain Trial", - "phase": "", - "drugs": "['Coronary CT Angiography', 'Stress Test']", - "drugs_list": [ - "Coronary CT Angiography", - "Stress Test" - ], - "diseases": "['Chest Pain', 'Shortness of Breath', 'Suspected Acute Coronary Syndrome']", - "diseases_list": [ - "Chest Pain", - "Shortness of Breath", - "Suspected Acute Coronary Syndrome" - ], - "enrollment": "411.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with chest pain or SOB admitted for rule out acute coronary syndrome \n\n Age \u226545 years \n\n EKG non-diagnostic for acute coronary syndrome \n\n At least 1 set of negative troponin I \n\n ", - "exclusion_criteria": ": \n\n Patient with ST elevation myocardial infarction. \n\n Patients with non-ST elevation myocardial infarction. \n\n Patients with known CAD. \n\n Patients with serum creatinine > 1.5. \n\n Atrial fibrillation or marked irregular heart rhythm. \n\n Patients in whom heart rate cannot be controlled. \n\n Patient with allergies to iodinated contrast agents. \n\n Pregnant women \n\n Patients unable to give informed consent", - "brief_summary": "The purpose of this study is to determine the best initial test in patients admitted to the hospital complaining of chest pain.", - "NCTID": "NCT01604655" - }, - { - "brief_title": "AngioSeal Versus Radial Approach in Acute Coronary Syndrome", - "phase": "Phase 4", - "drugs": "['Percutaneous coronary intervention']", - "drugs_list": [ - "Percutaneous coronary intervention" - ], - "diseases": "['Acute Coronary Syndrome']", - "diseases_list": [ - "Acute Coronary Syndrome" - ], - "enrollment": "240.0", - "inclusion_criteria": "inclusion criteria: \n\n Non-ST-segment elevation ACS patients [ischemic symptoms suspicious of non-ST-segment elevation ACS (unstable angina or non-ST-segment elevation AMI) defined as clinical presentation compatible with a new manifestation of worsening of chest pain characteristic of ischemia, at rest or at minimum effort, lasting more than 10 minutes, and at least one of the following items: (a) ECG changes compatible with new ischemia (ST segment depression of at least 1 mm, or transient ST segment elevation, or ST segment elevation \u2264 1 mm, or T wave inversion > 2 mm in at least 2 contiguous shunts); (b) cardiac enzymes (CK-MB or troponin T or I) above the upper normality range limit; (c) patients > 60 years of age without ECG or myocardial necrosis markers changes, however with previous documentation of coronary atherosclerotic disease (CAD), confirmed by previous hospitalization due to AMI, previous percutaneous or surgical myocardial revascularization procedure, significant CAD confirmed by coronary angiography, or positive functional test for myocardial ischemia]; \n\n Intention to submit patient to early invasive strategy consisting of coronary angiography immediately followed by PCI, when applicable, in the first 72 hours after admission; \n\n Signed informed consent; \n\n Patient eligible for transradial and transfemoral coronary angiography and PCI, being pre-requisites: (a) palpable radial artery with normal Allen test or/and oximetry tests, (b) familiarity of the operator with the radial and femoral techniques using AngioSeal, (c) agreement of the operator to use the access route determined by the randomization process. \n\n ", - "exclusion_criteria": ": \n\n Less than 18 years of age; \n\n Pregnancy; \n\n Chronic use of vitamin K antagonists or direct thrombin inhibitors, or oral Xa-factor antagonists; \n\n Hypersensitivity to antiplatelet and/or anticoagulant drugs; \n\n Active bleeding or high bleeding risk (severe liver failure, active peptic ulcer, creatinine clearance < 30 mL/min, platelets count < 100.000 mm3); \n\n Uncontrolled systemic hypertension; \n\n Cardiogenic shock; \n\n Previous myocardial revascularization surgery with \u2265 1 internal mammary or radial artery graft; \n\n Documented chronic peripheral arterial disease preventing the use of the femoral technique; \n\n Severe concomitant disease with life expectancy below 12 months; \n\n Participation in drug or devices investigative clinical trials in the last 30 days; \n\n Indication of elective percutaneous coronary intervention to be performed in a moment different from immediately after coronary angiography; \n\n Medical, geographic or social conditions impairing the participation in the study or inability to understand and sign the informed consent term.", - "brief_summary": "Among non-ST-segment elevation acute coronary syndrome patients submitted to early invasive strategy and randomized for the transfemoral or transradial approach, the AngioSeal vascular closure device would decrease the prevalence of vascular complications at puncture site, reaching the non-inferiority criterion when compared to the radial access.", - "NCTID": "NCT01653587" - }, - { - "brief_title": "Rule Out Myocardial Infarction by Computer Assisted Tomography", - "phase": "", - "drugs": "['Cardiac Computed Tomography']", - "drugs_list": [ - "Cardiac Computed Tomography" - ], - "diseases": "['Acute Coronary Syndrome', 'Myocardial Infarction', 'Unstable Angina Pectoris']", - "diseases_list": [ - "Acute Coronary Syndrome", - "Myocardial Infarction", - "Unstable Angina Pectoris" - ], - "enrollment": "368.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with any episode > five minutes of chest pain being admitted to rule out acute coronary syndrome \n\n ", - "exclusion_criteria": ": \n\n Positive initial troponin or CK-MB tests \n\n Diagnostic ECG changes (ST- segment elevation or horizontal ST- segment depression in more than two contiguous leads) \n\n Unstable clinical condition (hemodynamically unstable, ventricular tachycardia, persistent chest pain despite adequate therapy) \n\n Creatinine Clearance <50 mL/min \n\n Known allergy to iodinated contrast agents \n\n Patients on metformin therapy unable or unwilling to discontinue therapy for 48 hours after CT scan procedure \n\n Known asthma, reactive airway disease \n\n Patients currently in atrial fibrillation \n\n Previous intolerance to beta blocker \n\n Patients that are referred for coronary angiography/PCI by their PCP or cardiologist.", - "brief_summary": "The goal of this research is to determine noninvasively whether detection of coronary stenosis and plaque by multidetector computed tomography (MDCT) in patients with acute chest pain suspected of acute coronary syndrome (ACS) enhances triage, reduces cost and is cost effective. Among the 5.6 million patients with ACP presenting annually in emergency departments (ED) in the United States, a subgroup of two million patients is hospitalized despite normal initial cardiac biomarker tests and electrocardiogram (ECG). This subgroup is at low (20%) risk for ACS during the index hospitalization. Most (80-94%) patients with a diagnosis of ACS have a significant epicardial coronary artery stenosis ( >50% luminal narrowing). However, in -10% of patients non-stenotic coronary plaque triggers events, i.e. vasospasms, leading to myocardial ischemia. Since the absence of plaque excludes a coronary cause of chest pain, these patients could in theory be discharged earlier reducing unnecessary hospital admissions. Recent publications demonstrate high sensitivity and specificity of MDCT for the detection of significant coronary stenosis compared with coronary angiography and the detection of coronary plaque as validated with intravascular ultrasound. Using 64- slice MDCT we propose to study 400 patients with ACP, negative initial cardiac biomarkers and non-diagnostic ECG. We will analyze MDCT images for the presence of significant coronary artery stenosis and plaque and correlate the data with the clinical diagnosis of ACS (AHA guidelines) during the index hospitalization to determine the sensitivity and specificity. MDCT data, risk factors, and the results of standard diagnostic tests available at the time of MDCT will be used to generate a multivariate prediction function and derive a clinical decision rule. Based on this decision rule we will compare the diagnostic accuracies and cost effectiveness of competing strategies. We hypothesize that an MDCT- based diagnostic strategy will reduce the time to diagnosis of ACS, number of hospitalizations, and absolute cost of management of patients with acute chest pain compared to standard clinical care and is cost effective.", - "NCTID": "NCT00990262" - }, - { - "brief_title": "Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography", - "phase": "Phase 3", - "drugs": "['Cardiac Computed Tomography']", - "drugs_list": [ - "Cardiac Computed Tomography" - ], - "diseases": "['Acute Coronary Syndrome', 'Myocardial Infarction', 'Unstable Angina Pectoris']", - "diseases_list": [ - "Acute Coronary Syndrome", - "Myocardial Infarction", - "Unstable Angina Pectoris" - ], - "enrollment": "1000.0", - "inclusion_criteria": "inclusion criteria: \n\n Participant had at least five minutes of chest pain or equivalent (chest tightness; pain radiating to left, right, or both arms or shoulders, back, neck, epigastrium, jaw/throat; or unexplained shortness of breath, syncope/presyncope, generalized weakness, nausea, or vomiting thought to be of cardiac origin) at rest or during exercise within 24 hours of ED presentation, warranting further risk stratification, as determined by an ED attending. \n\n 2 or more cardiac risk factors (diabetes, hypertension, hyperlipidemia, current smoker and family history of coronary artery disease). \n\n Able to provide a written informed consent. \n\n <75 years of age, but >40 years of age. \n\n Able to hold breath for at least 10 seconds. \n\n Sinus rhythm. \n\n ", - "exclusion_criteria": ": \n\n New diagnostic ischemic ECG changes (ST-segment elevation or depression > 1 mm or T-wave inversion > 4 mm) in more than two anatomically adjacent leads or left bundle branch block \n\n Documented or self-reported history of CAD (MI, percutaneous coronary interventions [PCIs], coronary artery bypass graft [CABG], known significant coronary stenosis [>50%]) \n\n Greater than 6 hours since presentation to ED. \n\n BMI >40 kg/m2 \n\n Impaired renal function as defined by serum creatinine >1.5 mg/dL* \n\n Elevated troponin-T (> 0.09 ng/ml) \n\n Hemodynamically or clinically unstable condition (BP systolic < 80 mm Hg, atrial or ventricular arrhythmias, persistent chest pain despite adequate therapy) \n\n Known allergy to iodinated contrast agent \n\n Currently symptomatic asthma \n\n Documented or self-reported cocaine use within the past 48 hours (acute) \n\n On Metformin therapy and unable or unwilling to discontinue for 48 hours after the CT scan \n\n Contraindication to beta blockers (taking daily antiasthmatic medication): This exclusion only applies to patients with a heart rate >65 bpm at sites using a non-dual source CT scanner \n\n Participant with no telephone or cell phone numbers or no address (preventing follow-up) \n\n Participant with positive pregnancy test. Women of childbearing potential, defined as <2 years of menopause in the absence of hysterectomy or tube ligation, must have a pregnancy test performed within 24 hours before the CT scan. \n\n Participant unwilling to provide a written informed consent.", - "brief_summary": "The growing availability of cardiac computed tomography (CT)* in emergency departments (EDs) across the U.S. expands the opportunities for its clinical application, but also heightens the need to define its appropriate use in the evaluation of patients with acute chest pain. To address this need, we performed a randomized diagnostic trial (RDT) to determine whether integrating cardiac CT, along with the information it provides on coronary artery disease (CAD) and left ventricular (LV) function, can improve the efficiency of the management of these patients (i.e. shorten length of hospital stay, increase direct discharge rates from the ED, decreasing healthcare costs and improving cost effectiveness while being safe).", - "NCTID": "NCT01084239" - }, - { - "brief_title": "Study of Percutaneous Renal Artery Intervention for Patient With Heart Failure", - "phase": "", - "drugs": "['Renal Artery Stenting']", - "drugs_list": [ - "Renal Artery Stenting" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Men and women age 18 or older referred for invasive evaluation of possible renal artery stenosis will be screened for enrollment. \n\n Patients must be inpatients admitted for heart failure exacerbation, or have been admitted to a hospital for heart failure exacerbation within the past 90 days. Heart failure is defined as physician documentation or report of any of the following clinical symptoms of heart failure described as dyspnea on exertion, dyspnea occurring in the supine position, fluid retention; or the description of rales, jugular venous distension, pulmonary edema on physical exam, or pulmonary edema on chest x-ray; without being clearly attributable to liver, kidney, or lung disease. Patients must have one of the following: 1. an ejection fraction of 50%; 2. an ejection fraction of 25-50% in the setting of a systolic blood pressure of at least 160 mmHg; or 3. an ejection fraction of 25-50% and a systolic blood pressure of at least 140 mmHg while being treated with at least 2 antihypertensive medications. Patients who meet these criteria and have a proven hemodynamically significant renal artery stenosis (as described in the procedure section) will be included \n\n ", - "exclusion_criteria": ": \n\n Patients with heart failure from structural heart disease (including greater than moderate dysfunction of the mitral or aortic valve), acute coronary syndrome, post-partum cardiomyopathy, or acute rejection of a transplanted heart will be excluded. Patients who are considered unlikely to survive to hospital discharge will be excluded. Patients with fibromuscular dysplasia, prior renal stenting, or anatomy unsuitable for renal stenting (i.e. prior vascular surgery making stent delivery impossible) will be excluded. Patients who are unable to take aspirin and clopidogrel will be excluded. Patients with a creatinine clearance <30 mL/min or a history of renal transplantation will be excluded. Pregnant women will be excluded. \n\n -", - "brief_summary": "This study will address the role of percutaneous renal intervention for a hemodynamically significant renal artery stenosis in patients with heart failure exacerbations. Current guidelines suggest evaluation for renal artery stenosis in patients with pulmonary edema or heart failure that cannot be attributed to poor left ventricular function. While case series have suggested benefit to percutaneous intervention in patients with heart failure, no randomized study has addressed the potential benefit of renal stenting for heart failure patients. Two large randomized trial of renal stenting for hypertension or poor kidney function failed to show benefit in patients with intermediate renal artery lesions. No evaluation of the potential hemodynamic significance of the lesions was performed prior to randomization. The investigators will enroll patients with heart failure exacerbations not attributable to declining left ventricular function, valvular disease, acute coronary syndrome, or heart transplant rejection, who on non-invasive imaging appear to have renal artery stenosis. After routine invasive assessment, including renal angiography and pressure-wire assessment, patients with hemodynamically significant renal artery stenoses will be randomized to stent implantation or medical therapy. Patients will then be followed to determine whether stenting impacts cardiac mortality or hospitalization for heart failure.", - "NCTID": "NCT01403714" - }, - { - "brief_title": "Cell Therapy in Myocardial Infarction", - "phase": "Phase 2; Phase 3", - "drugs": "['Autologous Bone Marrow Mononuclear Cells (ABMMC) Transplantation']", - "drugs_list": [ - "Autologous Bone Marrow Mononuclear Cells (ABMMC) Transplantation" - ], - "diseases": "['Acute Myocardial Infarction']", - "diseases_list": [ - "Acute Myocardial Infarction" - ], - "enrollment": "166.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients will be eligible if presenting all characteristics described below: \n\n ST segment elevation myocardial infarction in two or more contiguous leads, and according to the WHO definition, at least one of the following two: \n\n i) Presence of chest pain. ii) Elevation of the myonecrosis markers. \n\n Age between 30 and 80 years old. \n\n Ejection fraction \u226450% on Echocardiogram (Simpson) and segmentary dysfunction of the infarction area, measured between the 3rd and 5th day post AMI. \n\n Among patients submitted to thrombolytic therapy, the angioplasty of the related artery should be preferably done up to 24h after thrombolysis, with a maximum deadline of 72h after thrombolysis. \n\n ", - "exclusion_criteria": ": \n\n Patients will be ineligible if presenting any of the characteristics described below: \n\n AMI related artery presenting TIMI < 3 at the moment f cell injection. \n\n Left Main Coronary Artery Lesion of >50% or multivessel coronariopathy (>70% lesion in vessels with >2,0mm diameter in left anterior descending, circumflex and right coronary territory) indicating the need for CABG or angioplasty with three or more stents implant. \n\n Coronary anatomy, after thrombolytic reperfusion, presenting no need for angioplasty with stent implant. \n\n Final Diastolic Pression of the LV higher than 30 mmHg during ventriculography for evaluating EF inclusion criteria for the research protocol (item c of inclusion criteria). \n\n Cardiac arrest or Killip IV AMI at admission with need of ventilatory support. \n\n Cardiogenic shock persisting up to the third day after AMI (with need of Intra-aortic balloon pump or vasopressors). \n\n AMI mechanical complications (ventricular septal defect, papillary muscle rupture, and left ventricular free wall rupture). \n\n Significant valve disease, defined as aortic stenosis (mean systolic pressure gradient across the aortic valve >50mmHg), mitral stenosis with a valvar area less than 1,5 cm,2 moderate to severe aortic and/or mitral regurgitation. \n\n Chronic use of immunosuppressive agents. \n\n > 2,0 mg/dl creatinine or previous dialysis treatment. \n\n Presence of fever on the past 48h before injection glaring active systemic infection according to ACCP/SCCM (American College of Chest Physicians/Society of Critical Care Medicine) sepsis definition. \n\n Sustained ventricular tachycardia 48h after AMI. \n\n Illicit drugs abuse or alcohol abuse (based on DSM IV). \n\n Any co morbidity, with survival impact in two years. \n\n Myocarditis \n\n Active liver disease \n\n COPD in continuous steroids use. \n\n Hematological disease, neoplasm, bone disease or hemostatic disturbances. \n\n Inflammatory disease or chronicle infectious disease. \n\n Presence of definitive implantation of a cardiac pace maker or cardiac defibrillator. \n\n Impossibility to reach a cells suspension of 100 million mononuclear cells due to cells paucity in the bone marrow aspirate.", - "brief_summary": "The purpose of this study is to determine cell therapy efficacy in patients with ST elevation acute myocardial infarction (STEMI)", - "NCTID": "NCT00350766" - }, - { - "brief_title": "Renal Artery Calcium and Hypertension", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Hypertension', 'Atherosclerosis']", - "diseases_list": [ - "Hypertension", - "Atherosclerosis" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Every patient referred fo abdominal CT aged 30-100 \n\n ", - "exclusion_criteria": ": \n\n Contraindication for IV contrast injection failure to demonstrate renal arteries with contrast refusal to sign an informed consent", - "brief_summary": "CT of the abdomen is a very common examination performed for various indications.One of the common findings is vascular calcifications including calcifications of the renal arteries.Calcifications in the carotid arteries and coronary arteries are good predictor for obstructive atherosclerotic disease.Stenosis of the renal arteries can cause symptomatic or asymptomatic hypertension with subsequent clinical sequelae. Therefore early diagnosis of this condition is imperative.~The goal of our study is to investigate the correlation between incidental calcifications of the renal arteries in CT examinations and the presence of actual stenosis of these vessels in patients with and without hypertension.", - "NCTID": "NCT00388869" - }, - { - "brief_title": "Coronary Arteriosclerosis in Patients With Acute Ischemic Stroke", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Ischemic Stroke', 'Myocardial Ischemia', 'Coronary Arteriosclerosis']", - "diseases_list": [ - "Ischemic Stroke", - "Myocardial Ischemia", - "Coronary Arteriosclerosis" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 18 years old \n\n Symptoms suggestive of an acute ischemic stroke \n\n Informed consent \n\n ", - "exclusion_criteria": ": \n\n Present intracerebral or subarachnoid haemorrhage \n\n Present intracerebral vascular malformation \n\n Present transient ischemic attack \n\n Prior coronary bypass surgery or percutaneous coronary intervention \n\n Pacemaker \n\n Allergy to contrast \n\n Lack of cooperation", - "brief_summary": "The specific objectives of this thesis are in a cohort of patients with an acute ischemic stroke,~To establish the degree of coronary arteriosclerosis.~To describe left ventricular systolic and diastolic function in relation to changes of NT-proBNP.", - "NCTID": "NCT00701818" - }, - { - "brief_title": "Assessment of the Effects of Atorvastatin Therapy on Myocardial Deformation Characteristics, in Patients With STEMI", - "phase": "Phase 4", - "drugs": "['Atorvastatin']", - "drugs_list": [ - "Atorvastatin" - ], - "diseases": "['Myocardial Infarction']", - "diseases_list": [ - "Myocardial Infarction" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Signed Informed Consent Form \n\n Patients having physical and mental ability to participate in the study \n\n Patients of both sexes aged 35 to 65 years \n\n Presence of documented ST-elevation myocardial infarction confirmed by ECG, as well as troponin I and CK-MB levels. \n\n Presence of hemodynamically relevant stenosis of one artery (i.e., the infarct-related artery) confirmed by coronary angiography (CAG), with the occlusion of other arteries not exceeding 30%. \n\n ", - "exclusion_criteria": ": \n\n A history of repeat or recurrent myocardial infarction; \n\n A history of chronic heart failure (CHF) III-IV by New-York Heart Association (NYHA); \n\n Presence of left ventricular hypertrophy confirmed by echocardiography; \n\n QRS complex exceeding 1.0; \n\n Ejection fraction less than 40%; \n\n Presence of hemodynamically relevant stenosis exceeding 30% in several coronary arteries confirmed by CAG; \n\n Type 1 diabetes mellitus; \n\n Type 2 diabetes mellitus requiring pharmacotherapeutic correction with insulin; \n\n Any severe concurrent disease; \n\n A history of acute cerebrovascular accident (ACVA) within the 6 month period preceding the study; \n\n Active hepatic disease or liver enzyme elevation of unclear etiology more than 3 times higher than the upper limit of normal; \n\n Hepatic failure or bilirubin elevation more than 1.5 times higher than the upper limit of normal; \n\n Uncontrolled arterial hypertension (AH), with systolic blood pressure (SBP) exceeding 180 mm Hg and diastolic blood pressure (DBP) exceeding 110 mm Hg; \n\n A history of heart rhythm and/or cardiac conduction disorder; \n\n Inborn and/or acquired heart defects; \n\n A history of aortic aneurysm; \n\n Current existence of severe anemia (Hb < 100 g/L); \n\n Chronic renal disease (creatinine clearance < 30 mL/min); \n\n Uncorrected thyroid dysfunction, with hyper- or hypothyroidism; \n\n Intolerance of statins; \n\n Alcohol abuse and drug use; \n\n Participation in other clinical studies within the last two months.", - "brief_summary": "The primary goal~\u2022 To assess the effect of atorvastatin in patients treated since the first 24-96 hours of the disease on the parameters of global and regional myocardial deformation in the infarcted area and the structural and functional properties of arteries at day 7, at 12, 24, 36 and 48 weeks of treatment;~The secondary goals. To evaluate the effect of treatment:~on the parameters of the global and regional myocardial deformation in the intact area on day 7, on 12, 24, 36 and 48 weeks of treatment;~on the parameters of the global and regional myocardial deformation depending on the degree of coronary blood flow restoration by thrombolysis in myocardial infarction (TIMI)~on systolic and diastolic left ventricular function in the presence of initial impairments, or absence of the negative dynamics of these parameters in case of normal baseline values;~on the clinical diagnostic criteria for the development or progression of heart failure;~the dynamics of the duration and extent of myocardial ischemia according to the daily ECG monitoring on day 7, at 12, 24, 36 and 48 weeks of treatment;~the appearance of new prognostically significant cardiac arrhythmias~on the pulse wave velocity~the thickness of the intima-media complex (IMT); 200 patients are planned to be include in a randomized, single-center, open, prospective, controlled clinical trial, the enrollment will be held at the Department of Therapy of Medical Institute of Penza State University.~Definition of the study group:~The patients with STEMI (myocardial infarction with ST-segment elevation) will be included in the study~Group 1 STEMI - 100 patients receiving atorvastatin 80 mg / day for 48 weeks;~Group 2 STEMI - 100 patients receiving atorvastatin 20 mg / day for 48 weeks Planned number of patients: Pre-Screening - 300 subjects; screening and randomization - 200 subjects.~Patients will be randomized by random number generation to include in the group 1 or 2. All included patients will be on the standard basis therapy of the coronary artery disease, according to the national recommendation.", - "NCTID": "NCT02590653" - }, - { - "brief_title": "POSTconditioning During Coronary Angioplasty in Acute Myocardial Infarction Study", - "phase": "Phase 2", - "drugs": "['Postconditioning', 'Primary angioplasty and stenting without additional intervention']", - "drugs_list": [ - "Postconditioning", - "Primary angioplasty and stenting without additional intervention" - ], - "diseases": "['Myocardial Reperfusion Injury']", - "diseases_list": [ - "Myocardial Reperfusion Injury" - ], - "enrollment": "78.0", - "inclusion_criteria": "inclusion criteria: \n\n clinical evidence of myocardial infarction defined by the presence of ischemic chest pain lasting more than 30 minutes, with a time interval from the onset of symptoms less than 6 hours before hospital admission, associated with typical ST-segment elevation on the 12-lead ECG \n\n angiographic-detected culprit lesion with stenosis diameter >70% and TIMI flow grade <=1 \n\n ", - "exclusion_criteria": ": \n\n previous acute myocardial infarction \n\n previous myocardial revascularization (angioplasty or coronary bypass) \n\n previous heart valve replacement \n\n previous heart transplant \n\n clinical instability precluding the suitability of the study \n\n cardiogenic shock or persistent hypotension (systolic blood pressure <100 mmHg) \n\n rescue angioplasty after thrombolytic therapy \n\n evidence of coronary collaterals (Rentrop grade>0) in the risk area \n\n advanced atrioventricular block \n\n significant bradycardia \n\n absence of sinus rhythm \n\n inability to lay flat (due to severe cardiac heart failure/respiratory insufficiency) \n\n history or clinical evidence of bronchospastic lung disease \n\n pregnancy \n\n known existence of a life-threatening disease with a life expectancy <6 months \n\n inability to give informed consent \n\n any contraindication to undergo cardiac-MRI, such as implanted metallic objects (cardiac pacemakers and/or implantable cardioverter defibrillator, implanted insulin pumps or any other type of electronic devices, cerebral clips, aneurysm clips) or any other contraindication to cardiac-MRI (such as claustrophobia)", - "brief_summary": "The POST-conditioning during coronary angioplasty in Acute Myocardial Infarction (POST-AMI) trial will evaluate the usefulness of postconditioning in limiting infarct size and microvascular damage during the early and late phases after AMI.", - "NCTID": "NCT01004289" - }, - { - "brief_title": "Stenting of Renal Artery Stenosis in Coronary Artery Disease Study", - "phase": "Phase 3", - "drugs": "['stenting angioplasty plus medical therapy', 'Medical therapy']", - "drugs_list": [ - "stenting angioplasty plus medical therapy", - "Medical therapy" - ], - "diseases": "['Renal Artery Stenosis', 'Left Ventricular Hypertrophy']", - "diseases_list": [ - "Renal Artery Stenosis", - "Left Ventricular Hypertrophy" - ], - "enrollment": "168.0", - "inclusion_criteria": "inclusion criteria: \n\n ischemic heart disease \n\n angiographic diagnosis of atherosclerotic RAS >50% and \u226480% \n\n ", - "exclusion_criteria": ": \n\n Atherosclerotic RAS>80% \n\n RAS secondary to fibromuscular dysplasia \n\n AMI \n\n single functioning kidney and/or sCr >4 mg/dl \n\n severe aortic valve stenosis \n\n aortic aneurism necessitating surgery", - "brief_summary": "The Stenting of Renal Artery Stenosis in Coronary Artery Disease (RASCAD) study is a randomized controlled trial designed to evaluate the effect of renal artery stenting+medical therapy versus medical therapy alone on left ventricular mass progression and cardiovascular morbidity and mortality in patients affected by coronary artery disease and renal artery stenosis.", - "NCTID": "NCT01173666" - }, - { - "brief_title": "Supramaximal Titrated Inhibition of RAAS in Dilated Cardiomyopathy", - "phase": "Phase 4", - "drugs": "['Benazepril', 'Valsartan', 'Metoprolol']", - "drugs_list": [ - "Benazepril", - "Valsartan", - "Metoprolol" - ], - "diseases": "['Dilated Cardiomyopathy']", - "diseases_list": [ - "Dilated Cardiomyopathy" - ], - "enrollment": "480.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of dilated cardiomyopathy \n\n Left ventricular ejection fraction < 35% \n\n NYHA Functional classes of II-IV \n\n Symptomatic but not rapidly deteriorating 1 month before enrollment \n\n Signed informed consent \n\n ", - "exclusion_criteria": ": \n\n Contradictions and intolerance of the studied drugs: \n\n supine systolic arterial blood pressure < 90 mmHg, \n\n renal artery stenosis >50%, \n\n pregnancy or lactation, \n\n impaired renal function (estimated glomerular filtration rate < 60 ml/min/1.73m2, \n\n impaired liver function (total bilirubin >2 times upper limit of normal, \n\n serum aspartate AST or alanine ALT >3 times the upper limit of normal), \n\n hemoglobin less than 8 mg/dl, hyperkalaemia (serum potassium >5.5mmol/l), \n\n obstructive lung disease, \n\n advanced atrioventricular block, \n\n any co-morbidity with impact on survival, and \n\n known intolerance to benazepril, valsartan and metoprolol succinate; \n\n HF secondary to a known cause: \n\n coronary artery disease based on coronary angiography (\u226550% stenosis in \u22651 of the major coronary arteries) and/or a history of myocardial infarction or angina pectoris, \n\n acute or subacute stage of myocarditis, \n\n primary valve disease, \n\n diabetes mellitus, \n\n excessive use of alcohol or illicit drugs; \n\n Expected or performed cardiac resynchronization therapy and heart transplantation.", - "brief_summary": "Dilated cardiomyopathy (DCM) is a poorly understood cause of systolic heart failure and is the most common indication for heart transplantation worldwide. Despite advances in medical and device therapy, the 5-year mortality of patients with DCM remains high.~Patients diagnosed of dilated cardiomyopathy with a NYHA functional class of II to IV and left ventricular ejection fraction(LVEF) <35% were selected for randomized controlled study of the efficacy and safety of high dose Renin-angiotensin system (RAS) inhibitor (benazepril or valsartan), in comparison with low dose RAS inhibitor(benazepril or valsartan) and standard beta-adrenergic blocker therapy (metoprolol). The primary endpoint was all cause death or admission for heart failure. Additional prespecified outcomes included all-cause death, cardiovascular death, all-cause admission, heart failure admission. Secondary cardiovascular outcomes included the changes from baseline to the last available observation after treatment in NYHA functional class, quality-of-life scores, LVEF, LVEDD, mitral regurgitation and wall-motion score index assessed by ECG. Adverse events were reported during in-hospital observation and follow-ups.", - "NCTID": "NCT01917149" - }, - { - "brief_title": "Rapid Intravascular Cooling in Myocardial Infarction as Adjunctive to Percutaneous Coronary Intervention", - "phase": "", - "drugs": "['Endovascular cooling by the Celsius Control System', 'Standard of care']", - "drugs_list": [ - "Endovascular cooling by the Celsius Control System", - "Standard of care" - ], - "diseases": "['Acute Anterior Myocardial Infarction']", - "diseases_list": [ - "Acute Anterior Myocardial Infarction" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Each eligible patient must meet the following inclusion criteria : \n\n Have ECG evidence of ongoing acute anterior myocardial infarction, involving a large area of myocardium, as defined by the following ECG criteria: a. Anterior infarct: ST-segment elevation >0.2mV measured 0.08 sec after the J point in 2 or more anatomically contiguous precordial leads, V1 through V4; and/or >0.2mV in lead V5 V6 \n\n Present to the RAPID MI-ICE site within six (6) hours of the onset of acute cardiac ischemic signs or symptoms (such as chest pain or pressure, arm or jaw pain, dyspnea, nausea/vomiting, or syncope) \n\n Be a candidate for PCI and have PCI planned as the immediate intervention. \n\n Be willing and able to comply with study procedures, including returning for the MRI scan at 4 \u00b12 days and return for the clinical examination on Day 30 \n\n Provide written informed consent prior to the initiation of study-specific procedures \n\n Be in Killips Class I \n\n ", - "exclusion_criteria": ": \n\n Patients are not eligible for the study if they meet one or more of the following criteria: \n\n Age less than eighteen (<18) years of age \n\n Age greater than seventy-five (>75) years of age \n\n Are pregnant \n\n Have a suspected aortic dissection \n\n History of a prior anterior myocardial infarct or prior large myocardial infarct. \n\n The suspected etiology of myocardial infarction is primarily related to substance abuse (e.g., cocaine, methamphetamine, etc.) \n\n Acute administration of a thrombolytic agent for the qualifying MI \n\n If (during the screening process) the determination is made by site-study personnel that initiation of cooling prior to diagnostic coronary angiography is technically not feasible for any reason (should the patient be randomized to the Hypothermia Arm), the prospective subject should not be enrolled \n\n Require an immediate surgical or procedural intervention other than PCI (e.g. CABG) \n\n Present in cardiogenic shock or with end-stage cardiomyopathy \n\n Have undergone at least ten (10) minutes of cardiopulmonary resuscitation (CPR) prior to presentation to the PCI facility \n\n History of previous MI with known, pre-existing, anterior pathologic Q-waves \n\n History of surgical coronary artery revascularization (e.g., CABG, MIDCAB, or OPCAB) \n\n Recent stroke (within 3 months) \n\n Active bleeding, coagulopathy, or other contraindication to the placement of a heparin-coated 14F central venous catheter via a 14F femoral venous introducer sheath (e.g., known history of heparin induced thrombocytopenia, or IVC filter) \n\n Contraindications to hypothermia, such as patients with known hematologic dyscrasias which affect thrombosis (e.g., cryoglobulinemia, sickle cell disease, serum cold agglutinins) or vasospastic disorders (such as Raynaud's or thromboangitis obliterans) \n\n Personal or familial history of malignant hyperthermia \n\n Known end-stage renal disease (ESRD; e.g., on dialysis, or status-post renal transplant), known hepatic failure (e.g., cirrhosis, or acute hepatitis), or any other contraindication to receiving meperidine (such as use of MAO inhibitors within previous 14 days, history of seizures, history of hypersensitivity to meperidine, etc.) [Note: Patients with a contraindication to buspirone administration may be enrolled but should not be given buspirone as part of the anti-shivering regimen.] \n\n Any other acute or chronic condition which the Investigator believes will unacceptably increase the risk of study participation or interfere with study procedures and assessments \n\n Deemed unsuitable by the investigators to participate in the study. \n\n Signs of cardiogenic shock or other signs of significant heart failure such as rales over the lungs \n\n Active or recent (within 1 month prior to study enrollment) participation in another investigational clinical research study", - "brief_summary": "Rapid MI-ICE-Pilot is designed to demonstrate the safety and efficacy of the Celsius Control\u2122 System (CCS) endovascular catheter to reduce the infarct size resulting from acute anterior myocardial infarction when used in combination with cold saline as an adjunct to immediate percutaneous coronary intervention (PCI) in patients with an occluded infarct-related artery.", - "NCTID": "NCT00417638" - }, - { - "brief_title": "Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration", - "phase": "Phase 1; Phase 2", - "drugs": "['CAP-1002 Allogeneic Cardiosphere-Derived Cells', 'Placebo']", - "drugs_list": [ - "CAP-1002 Allogeneic Cardiosphere-Derived Cells", - "Placebo" - ], - "diseases": "['Myocardial Infarction']", - "diseases_list": [ - "Myocardial Infarction" - ], - "enrollment": "156.0", - "inclusion_criteria": "inclusion criteria \n\n History of MI (STEMI or NSTEMI) within the prior 12 months due to a coronary artery event and evidenced by at least two of the following: typical ischemic symptoms, serial ST-T changes (new ST elevation or new left bundle block) and/or elevated troponin or CK-MB >5 times the upper limit of normal. Also at least one of the following: development of pathological Q wave ECG changes, imaging evidence of new loss of viable myocardium, or new regional wall motion abnormalities. \n\n History of percutaneous coronary intervention (PCI), with stent placement resulting in TIMI flow = 3, in the coronary artery supplying the infarcted, dysfunctional territory and through which the treatment will be infused. \n\n At least one assessment of left ventricular ejection function (LVEF) \u22640.45 as determined by any one of the standard modalities (echocardiography, ventriculography, nuclear imaging, CT and/or MRI) prior to or during the screening period. \n\n For subjects that fulfill the criteria of Recent MI (i.e., within 90 days of MI) at time of screening visit: assessment must be post-reperfusion after index MI and the most recent test prior to or during the screening period. \n\n For subjects that fulfill the criteria of Chronic MI (i.e., greater than 90 days from MI) at the time of screening visit: assessment must be at least 21 days post-reperfusion after index MI and the most recent test prior to or during the screening period. \n\n Note: subjects may screen as a Recent MI but be randomized into the Chronic MI strata if the infusion date is > 90 days post-MI. \n\n Left ventricular infarct size of \u2265 15% of left ventricular mass in the qualifying infarct-related region to be infused as determined by centrally read screening MRI, with associated thinning and/or hypokinesis, akinesis, or dyskinesis, with no large aneurysmal area in the infarcted regions. \n\n No further revascularization clinically indicated at the time the subject is assessed for participation in the clinical trial. \n\n Ability to provide informed consent and follow-up with protocol procedures. \n\n Age \u2265 18 years. \n\n ", - "exclusion_criteria": " \n\n Subjects with a history of coronary artery bypass surgery, and a patent graft (arterial or saphenous vein graft) attached to the coronary artery to be infused. \n\n Diagnosed or suspected myocarditis. \n\n History of cardiac tumor, or cardiac tumor demonstrated on screening MRI. \n\n History of acute coronary syndrome in the 4 weeks prior to study infusion. \n\n History of previous stem cell therapy. \n\n History of radiation treatment to the central or left side of thorax. \n\n Current or history (within the previous 5 years) of systematic auto-immune or connective tissue disease including, but not limited to, giant cell myocarditis, cardiac or systemic sarcoidosis, Dressler's syndrome, chronic recurrent or persistent pericarditis. \n\n History of or current treatment with immunosuppressive , anti-inflammatory, or other agents to treat manifestations of systemic immunologic reactions, including chronic systemic corticosteroids, biologic agents targeting the immune system, anti-tumor and anti-neoplastic drugs, anti-VEGF, or chemotherapeutic agents within 3 months prior to enrollment. \n\n Prior ICD and/or pacemaker placement where study imaging site has not been trained and certified specifically for this protocol to conduct cardiac MRI in subjects with ICD and/or pacemaker placement. \n\n a. Presence of a pacemaker and/or ICD generator with any of the following limitations/conditions are excluded: i. Manufactured before the year 2000, ii. Leads implanted < 6 weeks prior to signing informed consent, iii. Non-transvenous epicardial, abandoned, or no-fixation leads, iv. Subcutaneous ICDs, v. Leadless pacemakers, vi. Any other condition that, in the judgement of device-trained staff, would deem an MRI contraindicated. \n\n b. Pacemaker dependence with an ICD (Note: pacemaker-dependent candidates without an ICD are not excluded). \n\n c. A cardiac resynchronization therapy (CRT) device implanted < 3 months prior to signing informed consent. \n\n Estimated glomerular filtration rate < 30 mL/min. \n\n Participation in an on-going protocol studying an experimental drug or device, or participation in an interventional clinical trial within the last 30 days. \n\n Diagnosis of arrhythmogenic right ventricular cardiomyopathy. \n\n Current alcohol or drug abuse. \n\n Pregnant/nursing women and women of child-bearing potential that do not agree to use at least two forms of active and highly reliable method(s) of contraception. Acceptable methods of contraception include contraceptive pills, depo-progesterone injections, a barrier contraceptive such as a condom with or without spermicide cream or gel, diaphragms or cervical cap with or without spermicide or gel, or an intrauterine device (IUD). \n\n Human Immunodeficiency Virus (HIV) infection. \n\n Viral hepatitis. \n\n Uncontrolled diabetes (HbA1c>9%). \n\n Abnormal liver function (SGPT/ALT > 3 times the upper reference range) and/or abnormal hematology (hematocrit < 25%, WBC < 3000 \u00b5l, platelets < 100,000 \u00b5l) studies without a reversible, identifiable cause. \n\n Sustained ventricular tachycardia (VT) or non-sustained ventricular tachycardia > 30 beats, not associated with the acute phase of a previous MI (> 48 hours after the MI onset) or a new acute ischemic episode. \n\n Ventricular fibrillation not associated with a new acute ischemic episode. \n\n New York Heart Association (NYHA) Class IV congestive heart failure. \n\n Evidence of tumor on screening chest/abdominal/pelvic (body) CT scan. \n\n Any prior transplant. \n\n Known hypersensitivity to dimethyl sulfoxide (DMSO). \n\n Known hypersensitivity to bovine products. \n\n Any malignancy within 5 years (except for in-situ non-melanoma skin cancer and in-situ cervical cancer) of signing the ICF. \n\n Any condition or other reason that, in the opinion of the Investigator or Medical Monitor, would render the subject unsuitable for the study.", - "brief_summary": "The purpose of this study is to determine whether Allogeneic Cardiosphere-Derived Cells (CAP-1002) is safe and effective in decreasing infarct size in patients with a myocardial infarction.", - "NCTID": "NCT01458405" - }, - { - "brief_title": "Benefits of Medical Therapy Plus Stenting for Renal Atherosclerotic Lesions", - "phase": "Phase 3", - "drugs": "['Atacand/HCT, Caduet', 'GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting)']", - "drugs_list": [ - "Atacand/HCT", - "Caduet", - "GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting)" - ], - "diseases": "['Atherosclerosis', 'Cardiovascular Diseases', 'Hypertension, Renovascular', 'Renal Artery Obstruction']", - "diseases_list": [ - "Atherosclerosis", - "Cardiovascular Diseases", - "Hypertension", - "Renovascular", - "Renal Artery Obstruction" - ], - "enrollment": "947.0", - "inclusion_criteria": "inclusion criteria: \n\n Either \n\n Documented history of hypertension on two or more anti-hypertensive medications OR \n\n Renal dysfunction, defined as Stage 3 or greater chronic kidney disease (CKD) based on the new National Kidney Foundation (NKF) classifications (estimated glomerular filtration rate [GFR] less than 60 mL per minute per 1.73 m^2, calculated by the modified Modification of Diet in Renal Disease [MDRD] formula) \n\n One or more severe renal artery stenoses by any of the following pathways: \n\n a. Angiographic: greater than or equal to 60% and less than 100% by renal angiogram OR b. Duplex: systolic velocity of greater than 300 cm/sec OR c. Core Lab approved Magnetic Resonance Angiogram (MRA) (refer to the protocol for specific criteria) demonstrating stenosis greater than 80% OR stenosis greater than 70% with spin dephasing on 3D phase contrast MRA OR stenosis greater than 70% and two of the following: i. Ischemic kidney is greater than 1 cm. smaller than contralateral kidney ii. Ischemic kidney enhances less on arterial phase iii. Ischemic kidney has delayed Gd excretion iv. Ischemic kidney hyper-concentrates the urine v. 2-D phase contrast flow waveform shows delayed systolic peak vi. Post-stenotic dilatation d. Clinical index of suspicion combined with a Core Lab approved Computed Tomography Angiography (CTA) demonstrating Stenosis is greater than 80% by visual assessment on high quality CTA Stenosis is greater than 70% on CTA by visual assessment and there are two of the following i. The length of the ischemic kidney is greater than 1 cm. smaller than contralateral kidney ii. Reduced cortical thickness of ischemic kidney iii. Less cortical enhancement of ischemic kidney on arterial phase iv. Post-stenotic dilatation \n\n ", - "exclusion_criteria": ": \n\n Unable to provide informed consent \n\n Unable or willing to comply with study protocol or procedures \n\n Must be greater than 18 years of age \n\n Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to be present prior to randomization \n\n Pregnancy or unknown pregnancy status in female of childbearing potential \n\n Participation in any drug or device trial during the study period, unless approved by the Steering Committee \n\n Prior enrollment in the CORAL study \n\n History of stroke within 6 months, if associated with a residual neurologic deficit* \n\n Any major surgery, major trauma, revascularization procedure, unstable angina, or myocardial infarction 30 days prior to study entry* \n\n Any planned major surgery or revascularization procedure, outside of the randomly allocated renal stenting indicated by the protocol, after randomization* \n\n Hospitalization for heart failure within 30 days* \n\n Comorbid condition causing life expectancy of less than or equal to 3 years* \n\n Allergic reaction to intravascular contrast, not amenable to pre-treatment \n\n Allergy to stainless steel \n\n Allergy to all of the following: aspirin, clopidogrel, ticlopidine \n\n Known untreated aneurysm of the abdominal aorta greater than 5.0 cm.* \n\n Previous kidney transplant \n\n a. Stenosis of greater than 50% of a previously treated revascularized renal artery OR b. Treatment of any renal artery stenosis within the past 9 months (roll-in patients can have prior treatment on the contralateral side) \n\n Kidney size less than 7 cm. supplied by target vessel \n\n Hydronephrosis, nephritis or other known cause of renal insufficiency, not due to large vessel renal artery stenosis \n\n Visualized stenosis of only an accessory renal artery supplying greater than 1/2 of the ipsilateral renal parenchyma, without stenosis in a dominant renal artery \n\n Local lab serum Cr greater than 4.0 mg/dl on the day of randomization* \n\n Presence of a renal artery stenosis not amenable for treatment with a stent, known to be present prior to randomization \n\n The index lesion cannot be treated with a single stent (i.e. greater than 18 mm. in length) \n\n The placement of a stent will necessitate covering a renal artery branch renal artery with a stent \n\n The stenosis is in an artery less than 3.5 mm. in diameter \n\n The stenosis involves a segmental renal artery branch \n\n Abrupt vessel closure or dissection after diagnostic angiography [NOTE: Patients with abrupt vessel closure or dissection as a result of diagnostic angiography will not be randomized but will undergo stent revascularization, receive optimal medical therapy and will be followed for the full study period] *Roll-in patients do not need to meet these inclusion/", - "brief_summary": "This study will compare medical therapy plus stenting of hemodynamically significant renal artery stenoses versus medical therapy alone in patients with systolic hypertension and renal artery stenosis.", - "NCTID": "NCT00081731" - }, - { - "brief_title": "Comparison of Stenting Versus Best Medical Therapy for Treatment of Ostial Renal Artery Stenosis: a Trial in Patients With Advanced Atherosclerosis", - "phase": "Phase 4", - "drugs": "['Herkulink renal artery Stent', 'best medical therapy']", - "drugs_list": [ - "Herkulink renal artery Stent", - "best medical therapy" - ], - "diseases": "['Renal Artery Stenosis']", - "diseases_list": [ - "Renal Artery Stenosis" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n PAD and unilateral ostial >60% RAS and hypertension \n\n ", - "exclusion_criteria": ": \n\n Conditions which imply RAS stenting (bilateral significant renal disease, single functioning kidney, or patients whose conditions cannot be managed medically or by intervention) \n\n Allergy to contrast agents or medication administered for best medical treatment (in particular ASA and statins)", - "brief_summary": "Renal artery stenosis (RAS) usually refers to a disease of the large extra-renal arterial vessels and most frequently is caused by atherosclerotic obstructions. The prevalence of atherosclerotic RAS increases with age, male gender, traditional cardiovascular risk factors (hypertension, diabetes, smoking, hyperlipidemia) and atherosclerotic comorbidities like coronary artery or peripheral artery disease (PAD). A prevalence up to 40% has been reported in patients with PAD. Undoubtedly, atherosclerotic RAS is a progressive disease, as more than half of the patients exhibit an increasing degree of stenosis within five years after diagnosis, and one out of five patients with a critical stenosis (>60%) suffers renal atrophy and renal failure during this period. RAS may be treated conservatively by so called best medical treatment, surgically, or by endovascular interventions using balloon angioplasty and stenting.~The purpose of the investigators study is to determine the incidence and the predictors of RAS in patients with PAD, and to compare the effect of renal artery stenting versus best medical treatment in patients with hypertension and ostial renal artery stenosis in a randomized controlled trial.", - "NCTID": "NCT00711984" - }, - { - "brief_title": "Renal Fractional Flow Reserve in Renal Artery Stenting", - "phase": "", - "drugs": "['Renal artery stenting']", - "drugs_list": [ - "Renal artery stenting" - ], - "diseases": "['Renal Artery Stenosis', 'Hypertension']", - "diseases_list": [ - "Renal Artery Stenosis", - "Hypertension" - ], - "enrollment": "45.0", - "inclusion_criteria": "inclusion criteria: \n\n At least moderate (60% or more) renal artery stenosis with atheromatic appearance in angiography \n\n Hypertension defined according to WHO criteria \n\n Age 18-75 years \n\n Signed informed consent obtained \n\n ", - "exclusion_criteria": ": \n\n Bilateral renal artery stenosis or significant renal artery stenosis in solitary kidney \n\n Contraindications to percutaneous renal angioplasty with stenting \n\n Atrophy of the kidney supplied with stenosed artery \n\n Other well known secondary reason for hypertension \n\n Chronic heart failure NYHA II-IV \n\n Significant valvular heart disease qualified for surgery \n\n Persistent atrial fibrillation \n\n Renal failure with GFR below 30ml/min", - "brief_summary": "The purpose of the study is to determine potential utility of renal fractional flow reserve in prognosis predicting after renal stent implantation.", - "NCTID": "NCT01128933" - }, - { - "brief_title": "Revascularization Strategies for STEMI; The CMR Endpoint Study", - "phase": "", - "drugs": "['IRA-PCI', 'SS-PCI']", - "drugs_list": [ - "IRA-PCI", - "SS-PCI" - ], - "diseases": "['Acute Myocardial Infarction']", - "diseases_list": [ - "Acute Myocardial Infarction" - ], - "enrollment": "250.0", - "inclusion_criteria": "inclusion criteria: \n\n High risk ST elevation myocardial infarction evidenced by: \u22652 mm ST elevation in 2 anterior or lateral leads; or \u22652 mm ST elevation in 2 inferior coupled with ST depression in 2 contiguous anterior leads for a total ST deviation of \u22658 mm; or New left bundle branch block with at least 1 mm concordant ST elevation. \n\n Multivessel CAD as evidenced by \u22651 significant (\u226570% by visual assessment or FFR<0.80 for 50-70% stenosis) stenosis in non-IRA. \n\n Successful IRA-PCI with <10% residual angiographic stenosis and TIMI III flow. \n\n Written informed consent. \n\n ", - "exclusion_criteria": ": \n\n Age \u2264 18 years. \n\n Prior coronary artery bypass graft (CABG) surgery. \n\n Administration of thrombolytic therapy. \n\n Non-IRA stenosis is a chronic total occlusion or located in left main artery. \n\n Hemodynamic instability evidenced by BP<90 mmHg, Killip class \u22652, need for inotropes/vasopressors. \n\n Known renal insufficiency (estimated GFR < 50ml/min). \n\n Contraindication to CMR.", - "brief_summary": "Revascularization strategies for ST elevation myocardial infarction (STEMI) study (ASSIST-CMR) will compare the effects of two revascularization strategies [same sitting multivessel primary PCI (SS-PCI) and culprit vessel only primary PCI (IRA-PCI)] on myocardial infarct size (MIS) as determined by cardiac magnetic resonance (CMR) imaging in patients presenting with STEMI and multivessel disease (MVD).", - "NCTID": "NCT01818960" - }, - { - "brief_title": "Zainidip in Renal Artery Stenosis", - "phase": "Phase 4", - "drugs": "['stent', 'Aspirine', 'Clopidogrel', 'Lercanidipine']", - "drugs_list": [ - "stent", - "Aspirine", - "Clopidogrel", - "Lercanidipine" - ], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "149.0", - "inclusion_criteria": "inclusion criteria: \n\n Age between 40 - 75 \n\n Diameter of stenosis of renal artery or main branch of renal artery \u226560\uff05. If diameter of stenosis is 60% - 75%, pressure difference between proximal and distal end \u226520 mm Hg (1mmHg=0.133kPa) or Captopril renography positive; \n\n Systolic blood pressure before taking antihypertensive \u2265180mmHg and/or diastolic blood pressure \u2265110 mmHg; taking three antihypertensive including one diuretics with systolic blood pressure \u2265140mmHg and/or \u226590 mmHg; \n\n length of ipsilateral kidney is greater than 7.0cm. \n\n ", - "exclusion_criteria": ": \n\n Estimated glomerular filtration rate (eGFR) <30 ml/ (min\ufe521.73 m 2) [eGFR (mL/min/1.73 m2) = 186.3 * serum creatinine (mg/dl) -1.154 * Age-0.203 * 0.742 (female)[11]; \n\n unstable condition and unable to tolerate interventional therapy; \n\n anatomy of renal artery pathology not suitable for interventional therapy; \n\n allergic to dihydropyridines; \n\n III degree atrioventricular block \n\n contrast allergy ; \n\n any known malignant tumor; \n\n non-compliant, history of alcoholism or drug abuse.", - "brief_summary": "To evaluate the efficacy of renal artery stent combined with standardized medical therapy as treatment for renal artery stenosis.", - "NCTID": "NCT02594410" - }, - { - "brief_title": "CD-NP (Cenderitide) Therapy for the Preservation of Left Ventricular Function", - "phase": "Phase 1", - "drugs": "['CD-NP']", - "drugs_list": [ - "CD-NP" - ], - "diseases": "['ST Elevation (STEMI) Myocardial Infarction of Anterior Wall']", - "diseases_list": [ - "ST Elevation (STEMI) Myocardial Infarction of Anterior Wall" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Significant chest discomfort and /or shortness of breath \n\n ST segment elevation (1.5 mV total) in two or more adjacent anterior precordial leads \n\n Successful reperfusion therapy (>TIMI grade 2 flow) either with thrombolytics or any mechanical forms of revascularization, including stent, PTCA, thrombectomy, etc. within 24 hours of onset of symptoms as documented by coronary angiography \n\n No previously known history of AMI (prior to current cardiac event) or no previous ECG (prior to current cardiac event) suggesting an old AMI (Q wave on presenting ECG is not an exclusion).. \n\n ", - "exclusion_criteria": ":(Assessed at the time of enrollment unless otherwise stated) \n\n Cardiogenic shock, acute heart failure or hypotension (Systolic BP < 90 mmHg) \n\n Previous known decreased EF < 40% \n\n Atrial Fibrillation \n\n Persistent signs and symptoms of Post MI ischemia \n\n Requirement of pressors for maintenance of blood pressure. \n\n Intra-aortic blood pump use \n\n Significant (moderate-severe) valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension. \n\n Severe congenital heart diseases \n\n Sustained ventricular tachycardia or ventricular fibrillation \n\n Second or third degree heart block without a permanent cardiac pacemaker \n\n Stroke within 3 months or other evidence of significantly compromised CNS perfusion \n\n Total bilirubin of > 2.5 mg/dL or other liver enzymes >2.5 times the upper limit of normal if available clinically and measured within the last 7 days \n\n Patients with calculated GFR <30 ml by MDRD equation or those with acute kidney injury as defined by an increase of plasma creatinine of 0.5 mg/dL from a plasma creatinine measured within the last 7 days \n\n Serum sodium of < 125 mEq/dL or > 160 mEq/dL if available clinically and measured within the last 7 days \n\n Serum potassium of < 3.0 mEq/dL or > 5.8 mEq/dL if available clinically and measured within the last 7 days \n\n Hemoglobin < 8.5 gm/dl if available clinically and measured within the last 7 days \n\n Other acute or chronic medical conditions or laboratory abnormality which may increase the risks associated with study participation or may interfere with interpretation of the data \n\n Received an investigational drug within 1 month prior to dosing \n\n Female subject who is pregnant or breastfeeding \n\n In the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any reasons", - "brief_summary": "The primary endpoint is to assess the safety and tolerability of Cenderitide (CD-NP) with the incidence of symptomatic hypotension being one of the key safety variables.", - "NCTID": "NCT02071602" - }, - { - "brief_title": "The MASS COMM Post-Randomization Phase Cohort Study", - "phase": "", - "drugs": "['PCI']", - "drugs_list": [ - "PCI" - ], - "diseases": "['Coronary Artery Disease']", - "diseases_list": [ - "Coronary Artery Disease" - ], - "enrollment": "2879.0", - "inclusion_criteria": "inclusion criteria: \n\n Candidates for this study must meet ALL of the following criteria: \n\n Subject is at least 18 years old. \n\n Subject requires single- or multi-vessel percutaneous coronary intervention (PCI) of de novo or restenotic target lesion (including in-stent restenotic lesions). N.B. staged procedure will not be considered to meet the endpoint component of repeat revascularization if either of the following pre-catheterization procedure qualifying clinical laboratory values are met: \n\n eGFR is less than 60 ml/min or \n\n creatinine is greater than 1.5 mg/dl \n\n Subject's lesion(s) is (are) amenable to stent treatment with currently available FDA-approved bare metal or drug eluting stents. \n\n Subject is an acceptable candidate for non-emergency, urgent or emergency CABG. \n\n Subject has clinical evidence of ischemic heart disease in terms of a positive functional study, or documented symptoms. \n\n Documented stable angina pectoris [Canadian Cardiovascular Society Classification (CCS) 1, 2, 3, or 4], unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), non-ST segment elevation myocardial infarction, or documented silent ischemia. \n\n Subject and the treating physician agree that the subject will comply with all follow-up evaluations. \n\n Subject has been informed of the nature and purpose of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site. \n\n Angiographic inclusion criteria \n\n The target lesion(s) is (are) de novo or restenotic (including in-stent restenotic) native coronary artery lesion(s) with greater or equal to 50 and less than 100% stenosis (visual estimate), or the target lesion is an acute (less than 1 month) total occlusion as evidenced by clinical symptoms. \n\n If Fractional Flow Reserve (FFR) is measured, target lesion(s) has (have) evidence of a hemodynamically significant stenosis determined by FFR measurement (FFR less than or equal to 0.8). \n\n Target lesions(s) is (are) located in an infarct (if not treated with primary PCI) or non-infarct-related artery with a 70% or greater stenosis (by visual estimate) greater than 72 hours following the STEMI. \n\n Lesions treated with PCI greater than 72 hours following STEMI would be subject to the same protocol inclusion/", - "exclusion_criteria": " listed above and below with the exception that a target lesion of 70% or greater stenosis may be treated with or without symptoms or abnormal stress test). \n\n ", - "brief_summary": "The primary objective of the Post-Randomization Phase Cohort Study is to continue to assess the safety of non-emergency PCI performed at hospitals without cardiac surgery on-site in patients with myocardial ischemia (other than ST-segment elevation myocardial infarction [STEMI]).", - "NCTID": "NCT02072421" - }, - { - "brief_title": "EXecutive Registry: Evaluating XIENCE V\u00ae in a Multi Vessel Disease", - "phase": "", - "drugs": "['Coronary artery placement of a drug-eluting stent']", - "drugs_list": [ - "Coronary artery placement of a drug-eluting stent" - ], - "diseases": "['Coronary Disease', 'Coronary Artery Disease', 'Coronary Artery Stenosis', 'Coronary Artery Restenosis']", - "diseases_list": [ - "Coronary Disease", - "Coronary Artery Disease", - "Coronary Artery Stenosis", - "Coronary Artery Restenosis" - ], - "enrollment": "400.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient must be at least 18 years of age \n\n Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V\u00ae EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site \n\n Patient has been diagnosed a MVD, as documented by coronary angiography, i.e. presenting a severe stenosis (>50%) amenable to PCI in at least 2 major epicardial vessels or their principal bifurcation branches (diagonal or obtuse marginal) \n\n Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram -ECG- consistent with ischemia) \n\n Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery \n\n Patient must agree to undergo all protocol-required follow-up examinations. \n\n Angiographic inclusion criteria \n\n Patients may receive up to 4 planned XIENCE V\u00ae EECSS stents, depending on the number of vessels treated and their respective lesion length. When multiple lesions are present in one or more main coronary branches, complete revascularization should be attempted with the implantation of a maximum of 4 planned stents \n\n Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy) \n\n Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate \n\n Target lesion < or = 28 mm in length by visual estimation \n\n Target lesions must be in a major artery or its principal branches (diagonal or obtuse marginal) with a visually estimated stenosis of > or = 50% \n\n Two lesions in a single main coronary artery or its branches do not constitute a MVD situation, therefore this type of patient must not be enrolled \n\n ", - "exclusion_criteria": ": \n\n Patient has had a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure (non-procedural/spontaneous MI, CK-MB > or = to 2 times upper limit of normal) and CK and CK-MB have not returned within normal limits at the time of procedure \n\n Patient has current unstable arrhythmias \n\n Patient has a known left ventricular ejection fraction (LVEF) <30% \n\n Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant \n\n Patient is receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure. \n\n Patient is receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.) \n\n Patient is receiving chronic anticoagulation therapy (e.g. coumadin) \n\n Patient has a known hypersensitivity or contraindication to aspirin, paclitaxel, either heparin or bivalirudin, clopidogrel or ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated \n\n Elective surgery is planned within the first 9 months (+/- 14 days) after the procedure that will require discontinuing either aspirin or clopidogrel \n\n Patient has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis) \n\n Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dl, patient on dialysis) \n\n Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions \n\n Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months \n\n Patient has had a significant GI or urinary bleed within the past six months \n\n Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e. less than one year) \n\n Patient is already participating in another investigational use device or drug study or has completed the follow-up phase of another study within the last 30 days. \n\n Angiographic ", - "brief_summary": "The purpose of this two part study is the assessment of the performance of the XIENCE V\u00ae Everolimus Eluting Coronary Stent System (XIENCE V\u00ae EECSS) in the treatment of the specific setting of patients with Multi-Vessel Coronary Artery Disease (MVD).", - "NCTID": "NCT01310309" - }, - { - "brief_title": "Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization", - "phase": "", - "drugs": "['Percutaneous coronary intervention', 'FFR']", - "drugs_list": [ - "Percutaneous coronary intervention", - "FFR" - ], - "diseases": "['ST-elevation Myocardial Infarction', 'Multi Vessel Disease']", - "diseases_list": [ - "ST-elevation Myocardial Infarction", - "Multi Vessel Disease" - ], - "enrollment": "650.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 18 years. \n\n Acute onset of chest pain of < 12 hours' duration. \n\n ST-segment elevation \u2265 0.1 millivolt in \u2265 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block. \n\n Culprit lesion in a major native vessel. \n\n MVD (non-culprit vessels with angiographic stenosis >50%) \n\n Successful primary PCI \n\n ", - "exclusion_criteria": ": \n\n Pregnancy. \n\n Known intolerance of acetylsalicylic acid, clopidogrel, heparin or contrast. \n\n Inability to understand information or to provide informed consent. \n\n Haemorrhagic diathesis or known coagulopathy. \n\n Stent thrombosis \n\n Significant left main stem stenosis \n\n Cardiogenic shock at admittance", - "brief_summary": "In patients with ST-elevation myocardial infarction (STEMI) the primary treatment is acute angioplasty of the acute occlusion (culprit lesion). In STEMI patients with multi vessel disease (MVD) no evidence based treatment of the non-culprit lesions exists. We aim to provide evidence as to whether full revascularization or revascularization of the culprit lesion only provides the best prognosis for the patient.", - "NCTID": "NCT01960933" - }, - { - "brief_title": "EXCEL Clinical Trial", - "phase": "", - "drugs": "['Percutaneous Coronary Intervention', 'CABG']", - "drugs_list": [ - "Percutaneous Coronary Intervention", - "CABG" - ], - "diseases": "['Chronic Coronary Occlusion', 'Unprotected Left Main Coronary Artery Disease', 'Stent Thrombosis', 'Vascular Disease', 'Myocardial Ischemia', 'Coronary Artery Stenosis', 'Coronary Disease', 'Coronary Artery Disease', 'Coronary Restenosis']", - "diseases_list": [ - "Chronic Coronary Occlusion", - "Unprotected Left Main Coronary Artery Disease", - "Stent Thrombosis", - "Vascular Disease", - "Myocardial Ischemia", - "Coronary Artery Stenosis", - "Coronary Disease", - "Coronary Artery Disease", - "Coronary Restenosis" - ], - "enrollment": "1905.0", - "inclusion_criteria": "inclusion criteria: \n\n * inclusion criteria for RCT: \n\n Unprotected left main coronary artery (ULMCA) disease with angiographic diameter stenosis (DS) \u226570% requiring revascularization, or \n\n ULMCA disease with agniographic DS >=50% but < 70% requiring revascularization, with one or more of the following present: \n\n Non-invasive evidence of ischemia referable to a hemodynamically significant left main lesion (large area of ischemia in both the LAD and LCX territories, or in either the LAD or LCX territory in the absence of other obstructive coronary artery disease to explain the LAD or LCX defect), or stress-induced hypotension or stress-induced fall in LVEF, or stress-induced transient ischemic dilatation of the left ventricle or stress-induced thallium/technetiumlung uptake, and/or \n\n IVUS minimum lumen area (MLA) <= 6.0mm2, and/or \n\n Fractional Flow Reserve (FFR) <=0.80 \n\n Left Main Equivalent Disease \n\n Clinical and anatomic eligibility for both PCI and CABG \n\n Silent ischemia, stable angina, unstable angina or recent MI \n\n Ability to sign informed consent and comply with all study procedures including follow-up for at least three years \n\n ", - "exclusion_criteria": ": \n\n * Clinical ", - "brief_summary": "To establish the safety and efficacy of the commercially approved XIENCE Family Stent System (inclusive of XIENCE PRIME, XIENCE V, XIENCE Xpedition and XIENCE PRO [for use outside the United States [OUS] only]) in subjects with unprotected left main coronary artery disease by comparing to coronary artery bypass graft surgery.", - "NCTID": "NCT01205776" - }, - { - "brief_title": "A Clinical Evaluation of Absorb\u2122 Bioresorbable Vascular Scaffold (Absorb\u2122 BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT)", - "phase": "", - "drugs": "['XIENCE V EECSS', 'Absorb BVS System']", - "drugs_list": [ - "XIENCE V EECSS", - "Absorb BVS System" - ], - "diseases": "['Coronary Artery Disease', 'Coronary Artery Stenosis', 'Coronary Disease', 'Coronary Stenosis']", - "diseases_list": [ - "Coronary Artery Disease", - "Coronary Artery Stenosis", - "Coronary Disease", - "Coronary Stenosis" - ], - "enrollment": "480.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject must be at least 18 years of age at the time of signing the informed consent form. \n\n Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure. \n\n Subject must have evidence of myocardial ischemia (e.g., stable angina, unstable angina, post-infarct angina or silent ischemia) suitable for elective percutaneous coronary intervention (PCI). Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objective sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG. In the absence of noninvasive ischemia, fractional flow reserve (FFR) must be done and indicative of ischemia. \n\n Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery. \n\n Female subject of childbearing potential does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential, a pregnancy test must be performed with negative results known within 14 days (\u226414 days) prior to the index procedure per site standard test. \n\n Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure. \n\n Subject agrees to not participate in any other investigational clinical studies for a period of 1 year following the index procedure. \n\n ", - "exclusion_criteria": ": \n\n Any surgery requiring general anesthesia or discontinuation of aspirin and/or P2Y12 inhibitor is planned within 12 months after the index procedure. \n\n Subject has a known hypersensitivity or contraindication to device material (cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers) and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid). Subject has a known contrast sensitivity that cannot be adequately pre-medicated. \n\n Subject has a known allergic reaction, hypersensitivity or contraindication to: \n\n Aspirin; or \n\n All P2Y12 inhibitors (including clopidogrel and ticlopidine, and prasugrel and ticagrelor when they become available); or \n\n Heparin and bivalirudin. \n\n Subject had an acute myocardial infarction (AMI) within 7 days of the index procedure and both creatine kinase (CK) and creatine kinase myocardial-band isoenzyme (CK-MB) have not returned to within normal limits at the time of index procedure. \n\n Subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes. \n\n Subject has a cardiac arrhythmia as identified at the time of screening which at least one of the following criteria is met: \n\n Subject requires coumadin or any other agent for chronic oral anticoagulation. \n\n Subject likely to become hemodynamically unstable due to their arrhythmia. \n\n Subject has poor survival prognosis due to their arrhythmia. \n\n Subject has a known left ventricular ejection fraction (LVEF) < 30% assessed by any quantitative method. LVEF may be obtained within 6 months prior to the procedure for subjects with stable coronary artery disease (CAD). For subjects presenting with acute coronary syndrome (ACS), LVEF must be assessed during the index hospitalization (which may include during the index procedure by contrast left ventriculography) but prior to randomization in order to confirm the subject's eligibility. \n\n Subject has received CABG at any time in the past. \n\n Subject has undergone prior PCI within the target vessel during the last 12 months or undergone prior PCI within the non-target vessel within 30 days before the index procedure. \n\n Subject requires future staged PCI either in target or non-target vessels. \n\n Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants. \n\n At the time of screening, the subject has a malignancy that is not in remission. \n\n Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy. \n\n Subject has previously received or is scheduled to receive radiotherapy to coronary artery (vascular brachytherapy), or chest/mediastinum. \n\n Subject is receiving or will receive chronic anticoagulation therapy (e.g., coumadin or any other anticoagulation agents). \n\n Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3. \n\n Subject has a known or documented hepatic disorder as defined as cirrhosis or Child-Pugh \u2265 Class B. \n\n Subject has known renal insufficiency as defined as an estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 or dialysis at the time of screening. \n\n Subject is high risk of bleeding; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months; will refuse blood transfusions. \n\n Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months or any prior intracranial bleed, any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc.). \n\n Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the subject if radial or brachial access can be used. \n\n Subject has life expectancy < 2 years for any non-cardiac cause or cardiac cause. \n\n Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. \n\n Subject is currently participating in another clinical trial that has not yet completed its primary endpoint or protocol-required medications or invasive procedures. \n\n Angiographic inclusion criteria \n\n Assessment of angiographic eligibility is per visual assessment by an investigator both for qualitative and quantitative variables. On-line QCA is recommended to be used for appropriately sizing of the vessel. If on-line QCA cannot be used, visual estimation is required. \n\n One or two de novo target lesions: \n\n If there is one target lesion, a second non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful, uncomplicated result prior to randomization of the target lesion. \n\n If two target lesions are present, they must be present in different epicardial vessels and both satisfy the angiographic eligibility criteria. \n\n The definition of epicardial vessels means the left anterior descending artery (LAD), the left circumflex artery (LCX), and the right coronary artery (RCA) and their branches. Thus, for example, the subject must not have lesions requiring treatment in both the LAD and a diagonal branch. \n\n Target lesion must be located in a native coronary artery with a visually estimated or quantitatively assessed %DS of \u2265 50% and < 100% with a thrombolysis in myocardial infarction (TIMI) flow of \u2265 1 and one of the following: stenosis \u2265 70%, an abnormal functional test (e.g., fractional flow reserve, stress test), unstable angina or post-infarct angina. \n\n Target lesion must have a Dmax (by on-line QCA) or reference vessel diameter (RVD) (by visual estimation) \u2265 2.50 mm and \u2264 3.75 mm (on-line QCA assessment is recommended). \n\n Target lesion must have a lesion length \u2264 24 mm based on either visual estimation or on-line QCA. \n\n Angiographic ", - "brief_summary": "To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.", - "NCTID": "NCT01923740" - }, - { - "brief_title": "A Clinical Evaluation of the XIENCE PRIME Small Vessel Everolimus Eluting Coronary Stent System in Japanese Population", - "phase": "", - "drugs": "['XIENCE PRIME SV EECSS']", - "drugs_list": [ - "XIENCE PRIME SV EECSS" - ], - "diseases": "['Vascular Disease', 'Myocardial Ischemia', 'Coronary Artery Stenosis', 'Coronary Disease', 'Coronary Artery Disease', 'Coronary Restenosis']", - "diseases_list": [ - "Vascular Disease", - "Myocardial Ischemia", - "Coronary Artery Stenosis", - "Coronary Disease", - "Coronary Artery Disease", - "Coronary Restenosis" - ], - "enrollment": "65.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject must be at least 20 years of age. \n\n Subject or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements. \n\n Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia). \n\n Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery. \n\n Subject must agree to undergo all protocol-required follow-up procedures. \n\n Subject must agree not to participate in any other clinical study for a period of one year following the index procedure. \n\n Angiographic inclusion criteria \n\n One (target) or two (one target and one non-target) de novo lesions each in a different epicardial vessel. \n\n Lesion(s) must be located in a major artery or branch with a visually estimated diameter stenosis of \u2265 50% and < 100% with a TIMI flow of \u2265 1. \n\n Lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of \u2265 2.25 mm and < 2.5 mm. \n\n Lesion(s) must be located in a native coronary artery with length by visual estimation of \u2264 22 mm. \n\n ", - "exclusion_criteria": ": \n\n Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB \u2265 2 times upper limit of normal) and CK and CK-MB have not returned to within normal limits at the time of procedure. \n\n The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes. \n\n Subject has current unstable cardiac arrhythmias associated with hemodynamic instability. \n\n Subject has a known left ventricular ejection fraction (LVEF) < 40% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary). \n\n Subject has received coronary brachytherapy in any epicardial vessel. \n\n Subject has received any organ transplant or is on a waiting list for any organ transplant. \n\n Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure. \n\n Subject is receiving or scheduled to receive planned radiotherapy to the chest/mediastinum. \n\n Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.). \n\n Subject is receiving chronic anticoagulation therapy (e.g., heparin, warfarin). \n\n Subject will require Low Molecular Weight Heparin (LMWH) post-procedure. \n\n Subject has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated. \n\n Elective surgery is planned within 6 months after the procedure that will require discontinuing either aspirin or clopidogrel. \n\n Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood cell (WBC) of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis). \n\n Subject has known renal insufficiency (examples being but not limited to serum creatinine level \u2265 2.0 mg/dL, or on dialysis). \n\n Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions. \n\n Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months. \n\n Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months. \n\n Subject has extensive peripheral vascular disease that precludes safe 5 French catheter insertion. \n\n Subject has other medical illness (e.g., cancer) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year). \n\n Subject is currently participating in another clinical study that has not yet completed its primary endpoint. \n\n Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test*. \n\n Whether a subject who met this criterion will be asked for pregnancy test will be decided per site standard. However, subject enrollment in the study is not allowed without pregnancy test result. \n\n Angiographic ", - "brief_summary": "The purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System (EECSS) (2.25 mm diameter stent) in treatment of subjects with ischemic heart disease caused by de novo lesions.", - "NCTID": "NCT01115933" - }, - { - "brief_title": "Medical and Endovascular Treatment of Atherosclerotic Renal Artery Stenosis (METRAS Study)", - "phase": "Phase 4", - "drugs": "['Optimal medical therapy', 'revascularization']", - "drugs_list": [ - "Optimal medical therapy", - "revascularization" - ], - "diseases": "['Renal Artery Stenosis']", - "diseases_list": [ - "Renal Artery Stenosis" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n RAS affecting the main renal artery or its major branches at angio-CT either > 70% or, if < 70 with post-stenotic dilatation AND \n\n resistance index (RI) < 0.55 or > 0.55 but < 0.80 with evidence of intrarenal heterogeneity of the RI as revealed by a CV > 10% in the RI across the upper, mid and lower third of each kidney. \n\n ", - "exclusion_criteria": ": \n\n refusal to participate to study, \n\n previous endovascular or surgical treatment of RAS, \n\n fibromuscular RAS, \n\n planned or actual pregnancy, or childbearing potential without measures adequate to prevent pregnancy, \n\n life expectancy < 2 years, \n\n patient currently participating in another trial possibly influencing the safety of the patient and/or the outcomes of the study, \n\n co-morbid conditions limiting participation and follow-up.", - "brief_summary": "Renal atherosclerotic stenosis (RAS) is a prevalent cause of secondary hypertension (HT). Since there are still uncertainties as to whether and in what patients revascularization by means of percutaneous renal angioplasty (PTRAS) should be pursued, we designed a study exploiting an optimized patient selection strategy and using hard experimental endpoints to unravel these uncertainties.~Primary objective: to determine if revascularization by means of PTRAS is superior or equivalent to optimal medical treatment for preserving glomerular filtration rate in the ischemic kidney as assessed by 99mTcDTPA sequential renal scintiscan.~Secondary objectives: to determine if the two treatments are equivalent in lowering blood pressure (BP), preserving overall renal function and regressing damage in the target organs of hypertension.~Design: prospective multicenter randomized, unblinded two-arm study.~Eligible patients will have clinical and/or radiological evidence of unilateral or bilateral RAS, defined by stenosis of the proximal portion of the renal artery and its main bifurcations at angioCT. Duplex scan will exclude nephroangiosclerosis as the latter could bias the assessment of the outcome of revascularization.~Inclusion criteria. RAS affecting the main renal artery or its major branches at angio-CT either > 70% or, if < 70 with post-stenotic dilatation.~Renal function will be assessed with 99mTc-DTPA renal scintigraphy.~Sample size (30 patients per arm) was calculated to have a 90% power to detect a difference in means of GFR in the vascularized (or control untreated kidney) of 7.5 ml/min.~Arms~Revascularization: digital scan angiography and PTA with stenting of the renal artery at the ostium or at truncular level, plus optimal medical therapy.~Medical therapy: the drug regimen that had been optimized during the run-in period.~Experimental endpoints:~The absolute value of GFR assessed by 99TcDTPA in the ischemic kidney will be used as quantitative variable and compared between groups at each time point. A categorical definition of kidney loss, defined as a GFR in the ischemic kidney of < 5 ml/min, will be also used and the rate of achievement of such endpoint will be compared.~Duration: 5 years.", - "NCTID": "NCT01208714" - }, - { - "brief_title": "Safety and Feasibility of the Injectable BL-1040 Implant", - "phase": "Phase 1; Phase 2", - "drugs": "['BL-1040']", - "drugs_list": [ - "BL-1040" - ], - "diseases": "['Cardiovascular Disease']", - "diseases_list": [ - "Cardiovascular Disease" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Signed informed consent \n\n 18 to 75 years of age, inclusive \n\n Male or female \n\n Negative pregnancy test for women of child-bearing potential, or surgically sterile, or post menopausal \n\n Acute MI defined as: \n\n Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following: \n\n Ischemic symptoms; \n\n Development of pathologic Qwaves on the ECG; \n\n ECG changes indicative of ischemia (ST segment elevation or depression) \n\n First anterior or inferolateral STEMI or Qwave MI (QMI Anterior: V1-V3 or V1-V4 or V1-V5 or V1-V6.QMI Inferior: L2, L3, AVF, or L2, L3, AVF+ V5, V6 or L2, L3, AVF+ V6-V9 [posterior leads]) \n\n Regional wall motion score index (at least 4 out of 16 akinetic segments) \n\n One or more of the following: \n\n LVEF >20% and <45% measured and calculated by 2-dimensional measurement \n\n Biomarkers: peak CK > 2000 IU \n\n Infarct size > 25% as measured by MRI \n\n Successful revascularization with PCI with 1 stent only, within 7 days of the index MI \n\n At time of application of study device, patient must have patent infarct related artery (IRA) and TIMI flow grade = 3 \n\n ", - "exclusion_criteria": ": \n\n History of CHF, Class I to Class IV, as per NYHA criteria \n\n History of prior LV dysfunction \n\n At time of application of study device - Killip III-IV (pulmonary edema, cardiogenic shock - hypotension systolic < 90 mmHg and evidence of peripheral hypoperfusion oliguria, cyanosis, sweating) or HR > 100 bpm \n\n Prior CABG \n\n Prior MI \n\n History of stroke \n\n Significant valvular disease (moderate or severe) \n\n Patient is a candidate for CABG or PCI on non-IRA \n\n Patient is being considered for CRT within the next 30 days \n\n Renal insufficiency (eGFR < 60) \n\n Chronic liver disease (> 3 times upper limit of normal) \n\n Life expectancy < 12 months \n\n Current participant in another clinical trial, or participation in another trial within the last 6 months \n\n Any contraindication to coronary angiography, MRI or PCI procedures \n\n Patient taking anti-coagulation medication prior to MI \n\n Pregnant or lactating women; pregnancy confirmed by urine pregnancy test", - "brief_summary": "This is a Phase I, multi-center, open label study designed to assess the safety and feasibility of the injectable BL-1040 implant to provide scaffolding to infarcted myocardial tissue.", - "NCTID": "NCT00557531" - }, - { - "brief_title": "Echocardiography Management for Patients Requiring Care for Non-Cardiac Surgery", - "phase": "Phase 3", - "drugs": "['Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE)']", - "drugs_list": [ - "Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE)" - ], - "diseases": "['Cardiovascular Risk Factors']", - "diseases_list": [ - "Cardiovascular Risk Factors" - ], - "enrollment": "35.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 65 years \n\n Hypertension (HTN) \n\n Diabetes \n\n Obesity (body mass index [BMI] >35) \n\n Renal insufficiency \n\n Tobacco usage \n\n Hypercholesterolemia \n\n Sleep apnea/heavy snoring at night \n\n Clinical diagnosis of CHF as defined by: \n\n Dyspnea on exertion \n\n Paroxysmal nocturnal dyspnea \n\n Orthopnea \n\n Elevated jugular venous pressure \n\n Pulmonary rales \n\n Third heart sound \n\n Cardiomegaly or pulmonary edema on chest x-ray \n\n Peripheral edema \n\n Hepatomegaly \n\n Pleural effusion \n\n Palpitations/irregular heart beats \n\n Chest pain at rest and or exercise \n\n Murmur on examination \n\n Known coronary artery disease (CAD)/stents/coronary artery bypass graft (CABG) \n\n Known valvular disease \n\n Known stroke or transient ischemic attacks (TIA) \n\n ", - "exclusion_criteria": ": \n\n Patients expected to say in the hospital for less than 24 hours. \n\n Inability of undergo TEE and TTE \n\n Clinical evidence or suspicion of elevated intracranial pressure. \n\n Preoperative shock or systemic sepsis \n\n Emergency Operation \n\n ASA Class V \n\n Inability of give informed consent \n\n Participation in another clinical trial \n\n Prisoner", - "brief_summary": "The growing population of University of Nebraska Medical Center patients with heart failure combined with the increasing number of surgical procedures performed each year supports the need for a critical analysis of how to most appropriately manage these patients during the perioperative period, especially for non-cardiac surgery. Echo-guided hemodynamic management (EGHEM) is the use of echocardiography data to normalize and/or optimize in real-time, cardiac output and ventricular filling pressures in the perioperative period for non-cardiac surgical cases. The purpose of this study is to test the hypothesis that EGHEM compared to standard management practices will result in a reduced length of hospital stay in the noncardiac surgery population. The primary goal of health care providers for patients requiring anesthetic care, perioperative care, or critical care is ensuring the adequacy of the patient's circulatory function by optimizing cardiac output and ventricular filling pressure. Currently, the use of the ECG monitor and systemic blood pressure are the standard of care for assessing circulatory function. However, those data cannot provide accurate information on cardiac output and ventricular filling pressure for patients with cardiovascular risk factors and/or comorbidities. As a result, managing the hemodynamic parameters of these patients, as well as their intravenous fluid needs and resuscitation strategy, we hypothesize that using traditional approaches may lead to significant volume overload and post-operative cardiovascular complications and morbidity. In this study we propose an EGHEM strategy that incorporates standard echocardiography generated data points in addition to the systemic blood pressure and ECG signal to assess, manage, modify and optimize patient cardiac preload, afterload, heart rate and contractility in the perioperative period. Based on our initial observations and preliminary data using the EGHEM approach, we hypothesize that we can demonstrate a significant decrease in hospital length of stay and an overall decrease in perioperative morbidity at 30 days in the non-cardiac surgery population using EGHEM compared to standard practices. In this proposal we have designed a single center, prospective, randomized clinical trial to test our hypothesis.", - "NCTID": "NCT01050361" - }, - { - "brief_title": "Which One Should be Treated in the Setting of Acute ST Elevation Myocardial Infarction - Culprit Lesion or Culprit Vessel?", - "phase": "", - "drugs": "['Primary PCI']", - "drugs_list": [ - "Primary PCI" - ], - "diseases": "['Myocardial Infarction']", - "diseases_list": [ - "Myocardial Infarction" - ], - "enrollment": "637.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who underwent primary PCI for acute STEMI and had >1 lesion in the culprit artery \n\n ", - "exclusion_criteria": ": \n\n Presence of LMCA lesion \n\n Cardiogenic shock \n\n Previous CABG operation \n\n Decision for CABG operation after primary PCI \n\n Severe valvular disease including aortic stenosis of mitral insufficiency \n\n Severe kidney disease (serum creatinine >2.5 mg/dl or patients on maintenance hemodialysis) \n\n Rejection of second PCI by the patient after the index event", - "brief_summary": "The current guidelines still recommend emergent PCI of the culprit lesion and state that primary PCI should be limited to the culprit vessel with the exception of cardiogenic shock and persistent ischaemia after PCI of the supposed culprit lesion. This recommendation is based on a high number of studies. However, several studies are present about the safety and efficacy of non-culprit vessel PCI during acute MI. Nowadays, the debate is increasingly going on about the PCI of the non-culprit arteries during the index event with newer prospective randomized studies. Besides, it is still unclear for the culprit artery whether to treat only the culprit lesion or all the other lesions in the culprit vessel during the index event. The present report describes a retrospective comparison between the two strategies during primary PCI for STEMI, looking for their influence on the clinical and angiographic course of the patients.", - "NCTID": "NCT02356510" - }, - { - "brief_title": "Substrate Modification in Stable Ventricular Tachycardia in Addition to Implantable Cardioverter Defibrillator (ICD) Therapy", - "phase": "", - "drugs": "['Substrate modification', 'VT ablation', 'ICD Implantation']", - "drugs_list": [ - "Substrate modification", - "VT ablation", - "ICD Implantation" - ], - "diseases": "['Ventricular Tachycardia', 'Coronary Artery Disease', 'Left Ventricular Dysfunction']", - "diseases_list": [ - "Ventricular Tachycardia", - "Coronary Artery Disease", - "Left Ventricular Dysfunction" - ], - "enrollment": "110.0", - "inclusion_criteria": "inclusion criteria: \n\n Coronary artery disease For the purpose of this study, coronary artery disease will be defined as the presence of a 50 % or more diameter stenosis of the left main coronary artery, or 75 % or more diameter stenosis of the left anterior descending, circumflex or right coronary arteries, or the history of a surgical or percutaneous revascularization procedure, or history of successful thrombolysis, or a history of prior myocardial infarction (e.g.: documented by Q-wave, R-reduction, aneurysm) \n\n Left ventricular ejection fraction \u2264 50 % as estimated by echocardiography or contrast ventriculography within the previous 30 days and evidence for old myocardial infarction (ECG, echocardiographic or venticulographic). \n\n One episode of documented stable clinical VT without any reversible causes \n\n Written informed consent \n\n ", - "exclusion_criteria": ": \n\n Age < 18 years or > 80 year \n\n Protruding LV thrombus on pre-ablation echocardiogram \n\n Acute myocardial infarction within the preceding 1 months \n\n Class IV NYHA heart failure \n\n Valvular heart disease or mechanical heart valve precluding access to the left ventricle \n\n Unstable angina \n\n Cardiac surgery involving cardiotomy (not CABG) within the past 2 months \n\n Serum creatinine > 220 mmol/L (2.5 mg/dL) \n\n Thrombocytopenia or coagulopathy \n\n Contraindication to heparin \n\n Pregnancy \n\n Acute illness or active systemic infection \n\n Other disease process likely to limit survival to less than 12 months \n\n Significant medical problem that in the opinion of the principal investigator would preclude enrollment in the study \n\n Participation in another investigational study \n\n Unwillingness to participate or lack of availability for follow-up \n\n Incessant VT or electrical storm \n\n Bundle branch reentry tachycardia as the presenting VT \n\n Preexisting ICD", - "brief_summary": "The main objective of this study is to compare the time from randomization to the first recurrence of any ventricular tachycardia (VT) in patients undergoing VT ablation (for stable VTs) and substrate ablation (for unstable VTs) after an initial episode of stable VT and patients not undergoing ablation, with both groups under the protection of an ICD.", - "NCTID": "NCT00919373" - }, - { - "brief_title": "Clinical Study to Examine the Effects of Erythropoietin on Left Ventricular Function After Acute Myocardial Infarction", - "phase": "Phase 2", - "drugs": "['epoetin alfa']", - "drugs_list": [ - "epoetin alfa" - ], - "diseases": "['Myocardial Infarction']", - "diseases_list": [ - "Myocardial Infarction" - ], - "enrollment": "529.0", - "inclusion_criteria": "inclusion criteria: \n\n Successful primary PCI (TIMI 2/3) for a first acute myocardial infarction, diagnosed by: \n\n chest pain suggestive for acute myocardial infarction \n\n symptom onset < 12 hour before hospital admission, or < 24 hour in case ongoing ischemia \n\n ECG with ST-T segment elevation > 1 mV in 2 or more leads \n\n TIMI flow 0/1 before primary PCI on diagnostic coronary angiography; \n\n ", - "exclusion_criteria": ": \n\n Hemoglobin levels > 10.6 mmol/L; \n\n Anticipated additional revascularisation within 4 months; \n\n Cardiogenic shock; \n\n Presence of other serious medical conditions \n\n Pregnancy/breast feeding \n\n Malignant hypertension \n\n End stage renal failure (creatinin > 220 micromol/l) \n\n Previous treatment with rh-EPO \n\n Blood transfusion <12 weeks prior to randomisation \n\n Polycythemia vera \n\n Previous acute myocardial infarction \n\n Concomitant inflammatory or malignant disease \n\n Recent trauma or major surgery \n\n Unwilling to sign informed consent \n\n Atrial fibrillation", - "brief_summary": "The primary objective of this study is to establish the effects of a single bolus of EPO, administered within three hours after a primary PCI for a first acute myocardial infarction, on left ventricular function.", - "NCTID": "NCT00449488" - }, - { - "brief_title": "Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD.", - "phase": "", - "drugs": "['FFR-guided revascularisation strategy', 'randomised to guidelines group']", - "drugs_list": [ - "FFR-guided revascularisation strategy", - "randomised to guidelines group" - ], - "diseases": "['Myocardial Infarction', 'Multivessel Coronary Artery Disease']", - "diseases_list": [ - "Myocardial Infarction", - "Multivessel Coronary Artery Disease" - ], - "enrollment": "885.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients between 18-85 years presenting with STEMI who will be treated with primary PCI in < 12 h after the onset of symptoms* and have at least one stenosis of >50% in a non-IRA on QCA or visual estimation of baseline angiography and judged feasible for treatment with PCI by the operator. \n\n Patients with symptoms for more than 12 hr but ongoing angina complaints can be randomised \n\n ", - "exclusion_criteria": ": \n\n Left main stem disease (stenosis > 50%) \n\n STEMI due to in-stent thrombosis \n\n Chronic total occlusion of a non-IRA \n\n Severe stenosis with TIMI flow \u2264 II of the non-IRA artery. \n\n Non-IRA stenosis not amenable for PCI treatment (operators decision) \n\n Complicated IRA treatment, with one or more of the following; \n\n Extravasation, \n\n Permanent no re-flow after IRA treatment (TIMI flow 0-1), \n\n Inability to implant a stent \n\n Known severe cardiac valve dysfunction that will require surgery in the follow-up period. \n\n Killip class III or IV already at presentation or at the completion of culprit lesion treatment. \n\n Life expectancy of < 2 years. \n\n Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus and known true anaphylaxis to prior contrast media of bleeding diathesis or known coagulopathy. \n\n Gastrointestinal or genitourinary bleeding within the prior 3 months, \n\n Planned elective surgical procedure necessitating interruption of thienopyridines during the first 6 months post enrolment. \n\n Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. \n\n Pregnancy or planning to become pregnant any time after enrolment into this study. \n\n Inability to obtain informed consent. \n\n Expected lost to follow-up.", - "brief_summary": "The Compare-Acute trial is a prospective randomised trial in patients with multivessel disease, who are admitted into hospital with a ST-elevation Myocardial Infarction. The purpose of the study is to compare a FFR guided multivessel PCI taking place during the primary PCI with a primary PCI of the culprit vessel only.~Patients will be enrolled after successful revascularisation of the culprit vessel. Patients that have at least one lesion with a diameter of stenosis of more than 50% on visual estimation, feasible (operators judgement) for treatment with PCI in a non-infarct related artery, will be randomised either to the FFR guided complete revascularisation arm or staged revascularisation by proven ischemia or persistence of symptoms of angina.~Approximately 885 patients will be entered in the study.~Study hypothesis: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines.", - "NCTID": "NCT01399736" - }, - { - "brief_title": "Inflammation in Type 2 Myocardial Infarction", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Myocardial Infarction', 'Inflammation', 'Critical Illness']", - "diseases_list": [ - "Myocardial Infarction", - "Inflammation", - "Critical Illness" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n \u226521 years of age \n\n admitted to the Medical Intensive or Coronary Care Units \n\n sepsis or respiratory failure \n\n clinically indicated troponin measurement within 24 hours of ICU admission \n\n ", - "exclusion_criteria": ": \n\n unstable angina or Type 1 MI \n\n percutaneous or surgical coronary revascularization within 7 days \n\n heart failure exacerbation \n\n primary valvular disorder \n\n aortic dissection \n\n infiltrative heart disease or hypertrophic cardiomyopathy \n\n myocarditis \n\n pulmonary embolism \n\n electrocardiogram with >1mm ST segment elevation in two consecutive leads \n\n serum cardiac troponin >99th percentile URL but no clear rise or fall pattern \n\n history of chronic inflammatory disease \n\n use of therapeutic-dose anticoagulants / antiplatelet agents other than aspirin \n\n pregnant or incarcerated \n\n enrolled in a competing study", - "brief_summary": "Type 2 myocardial infarction (MI) is defined as myocardial necrosis that results from an imbalance of myocardial oxygen supply and demand. Although type 2 MI is highly prevalent in patients with critical illness and strongly associated with mortality, the pathophysiology remains poorly understood. Inflammation is central to the development of atherosclerosis, plaque rupture, and other subtypes of MI, but the role of inflammation in type 2 MI and myocardial necrosis has not been defined. The investigators aim to to delineate the mechanistic role of inflammation in myocardial necrosis and type 2 MI complicating critical medical illness.", - "NCTID": "NCT02385487" - }, - { - "brief_title": "Left Atrial Distensibility to Predict Left Ventricular Filling Pressure and Prognosis in Patients With Severe Mitral Regurgitation", - "phase": "", - "drugs": "['Cardiac catheterization']", - "drugs_list": [ - "Cardiac catheterization" - ], - "diseases": "['Mitral Valve Insufficiency', 'Atrial Fibrillation', 'Heart Failure']", - "diseases_list": [ - "Mitral Valve Insufficiency", - "Atrial Fibrillation", - "Heart Failure" - ], - "enrollment": "111.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with severe mitral regurgitation are admitted for surgical intervention and are willing to participate in this study. \n\n ", - "exclusion_criteria": ": \n\n Presence of mitral stenosis \n\n More than mild severity of aortic valvular problem \n\n Any abnormality of atrial septum (e.g., atrial septal defect or aneurysm) \n\n Rhythm other than sinus rhythm \n\n Inadequate image quality \n\n Lack of informed consent", - "brief_summary": "A large left atrial (LA) volume, which represents chronic diastolic dysfunction, is associated with a poor outcome, regardless of systolic function. Thus, the LA volume provides a long-term view of whether the patient has diastolic dysfunction, regardless of the loading conditions present at the examination, such as hemoglobin A1c in diabetes mellitus. To date, the relation between the LA volume and left ventricular (LV) filling pressure has not been confirmed directly by simultaneous echocardiographic catheterization. The present study, therefore, assessed the correlation between the LA volume and LV filling pressure in patients with severe mitral regurgitation (MR). Because the LA pressure increases to maintain adequate LV diastolic filling, increased atrial wall tension tends to dilate the chamber and stretch the atrial myocardium. Therefore, the lower the ability of the left atrium to stretch, the greater the pressure in the left atrium. The study is designed to assess 1) the relationship between LV filling pressure and LA distensibility, and 2) the power of left atrial distensibility to predict the prognosis, including operation mortality, the rate of post-operation atrial fibrillation, and late heart failure event in patients with severe mitral regurgitation.", - "NCTID": "NCT01172184" - }, - { - "brief_title": "REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation", - "phase": "", - "drugs": "['Renal sympathetic denervation', 'VT ablation alone']", - "drugs_list": [ - "Renal sympathetic denervation", - "VT ablation alone" - ], - "diseases": "['Ventricular Tachycardia']", - "diseases_list": [ - "Ventricular Tachycardia" - ], - "enrollment": "21.0", - "inclusion_criteria": "inclusion criteria: \n\n \u2265 18 years of age \n\n Structural heart disease (post-MI, dilated cardiomyopathy, sarcoid myopathy, hypertrophic cardiomyopathy, chagas-related cardiomyopathy, etc.) \n\n Planned for catheter-based ablation of VT \n\n All patients will have an existing ICD \n\n Accessibility of renal vasculature (determined by renal angiography) \n\n Ability to understand the requirements of the study \n\n Willingness to adhere to study restrictions and comply with all post- procedural follow-up requirements \n\n ", - "exclusion_criteria": ": \n\n MI or CVA within 30 days \n\n Coronary Artery Bypass Graft (CABG) within 30 days of this procedure \n\n Known renovascular abnormalities that would preclude RSDN (eg, renal artery stenosis) \n\n GFR <30 ml/min (unless receiving dialysis) \n\n Life expectancy <1 year for any medical condition \n\n Any condition resulting in a contraindication to anticoagulation (e.g. GI bleeding) \n\n Inability to give informed consent \n\n Known pregnancy or positive -HCG within 7 days of procedure.", - "brief_summary": "Despite significant advances in the management of ventricular arrhythmias through the use of ICD therapy, AADs, and catheter-based ablation strategies, considerable challenges remain. The optimal method for the prevention of recurrent VT following catheter ablation remains unclear. RSDN may be an effective tool for preventing ventricular arrhythmias, and associated ICD therapies, by reducing central sympathetic tone, catecholamine levels, and the renin-angiotensin- aldosterone system and promoting ventricular remodeling. Although RSDN has been shown to reduce the recurrence of VT in a case report of 2 patients suffering from electrical storm, to date no large prospective randomized study has evaluated the impact of RSDN in the prevention of recurrent VT in patients following catheter ablation of VT with ischemic or non-ischemic ventricular dysfunction. This study will specifically evaluate the safety and efficacy of adjunctive RSDN in the prevention of ICD therapy in patients with ischemic or non-ischemic ventricular dysfunction who are to receive a catheter-based VT ablation.", - "NCTID": "NCT01858194" - }, - { - "brief_title": "Numen Stent Assessment Using OCT Technique in a Single Center Study", - "phase": "Phase 2; Phase 3", - "drugs": "['Numen']", - "drugs_list": [ - "Numen" - ], - "diseases": "['Hyperplasia', 'Restenosis']", - "diseases_list": [ - "Hyperplasia", - "Restenosis" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria \n\n Patients must meet all of the following criteria: \n\n The patient must be > 18 years of age; \n\n Diagnosis of stable angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) or ACS (except STEMI). \n\n Treatment of de novo lesion in a major coronary artery in patients with single or two-vessel disease. \n\n Target vessel diameter at the lesion site is >2.50mm and <3.50mm in diameter (QCA); \n\n Target lesion is >10mm and <24mm in length (visual estimate); \n\n Target lesion stenosis is >50% and <100% (visual estimate); \n\n Acceptable candidate for coronary artery bypass surgery (CABG); \n\n Patient is willing to comply with the specified follow-up evaluation; \n\n Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee. \n\n ", - "exclusion_criteria": " \n\n Patients will be excluded if any of the following conditions apply: \n\n multiple lesions in the same vessel; \n\n ACS with STEMI (within 48 hours) \n\n vessel size < 2.50mm and >3.50mm reference diameter; \n\n length of the lesion > 24 mm; \n\n unprotected left main coronary disease with >50% stenosis; \n\n have an ostial target lesion; \n\n have a target lesion in a venous graft; \n\n angiographic evidence of thrombus within target lesion; \n\n calcified lesion which cannot be successfully predilated; \n\n Documented left ventricular ejection fraction >25%; \n\n Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment; \n\n Pretreatment with devices other than balloon angioplasty; \n\n Prior stent within 5mm of target lesion; \n\n Recipient of heart transplant; \n\n Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, cobalt, chromium, or contrast agent (that cannot be managed medically) \n\n Recent (6 months) cerebrovascular accidents or intracranial hemorrage \n\n Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study; \n\n Currently participating in an investigational drug or another medical device study; \n\n In the investigator's opinion, the lesion is not suitable for stenting. \n\n Life expectancy \u2264 12 months", - "brief_summary": "This is a prospective single centre Study designed to assess by OCT the effect of NUMEN cobalt-chromium balloon-expandable stent in inducing neointimal hyperplasia in de novo native coronary lesions of patients with Stable Angina Pectoris or ACS (except STEMI).~A total of 60 consecutive patients will be enrolled in the study. Patients with de novo native coronary artery lesions >10mm and <24mm in length and >2.50mm to <3.50mm in diameter by QCA estimate who meet all eligibility criteria will be enrolled and undergone stent implantation. After stent deployment an OCT imaging will be performed within the treated segment. Patients will be followed at 30 days, 6 months and 12 months post-procedure, with all patients having repeat angiography and OCT at 6 months.~It is anticipated that the total length of the study will be 18 months: 6 months to complete patient enrolment and 12 months for follow-up.", - "NCTID": "NCT00774917" - }, - { - "brief_title": "Safety and Efficacy of Conivaptan in Hyponatremic Patients With Symptomatic Acute Decompensated Heart Failure (ADHF)", - "phase": "Phase 3", - "drugs": "['conivaptan', 'placebo']", - "drugs_list": [ - "conivaptan", - "placebo" - ], - "diseases": "['Hyponatremia', 'Acute Decompensated Heart Failure']", - "diseases_list": [ - "Hyponatremia", - "Acute Decompensated Heart Failure" - ], - "enrollment": "9.0", - "inclusion_criteria": "inclusion criteria: \n\n Presents to emergency department with documented history of CHF and symptomatic ADHF, will be treated for ADHF, and primary reason for admission to the hospital is ADHF \n\n Dyspnea at rest or with minimal exertion and must have moderate shortness of breath (SOB) in any of the first three Provocative Dyspnea Assessment positions \n\n Severe pulmonary congestion as evidenced by jugular venous distention or lower extremity/sacral edema or rales upon chest auscultation or chest x-ray. \n\n BNP > 400 or NT-pro BNP > 1500 drawn during Screening \n\n Systolic blood pressure >= 100 mmHg to < 180 mmHg at time of start of study drug \n\n Serum sodium value >= 115 mEq/L (115 mmol/L) and < 135 mEq/L (135 mmol/L) during Screening \n\n ", - "exclusion_criteria": ": \n\n Clinical evidence of volume depletion \n\n Active ongoing acute coronary syndrome or acute ST segment elevation myocardial infarction (or has experienced a myocardial infarction within 30 days of Screening) \n\n In cardiogenic shock \n\n Calculated creatinine clearance < 30 mL/min/1.73 m2 as estimated by the Modification of Diet in Renal Disease (MDRD) equation, has received intravenous (IV) contrast agent within 72 hours prior to randomization or is expected to receive IV contrast agent within the first 72 hours of study participation \n\n Ultrafiltration within the past 72 hours. \n\n Currently using or expected to use inotropic therapy \n\n Cardiac bypass grafts in the past 60 days \n\n Cerebrovascular accident in the past 30 days \n\n Uncontrolled brady- or ventricular tachyarrhythmias requiring emergent pacemaker placement or treatment \n\n Hemodynamically significant uncorrected primary cardiac valvular disease or hypertrophic cardiomyopathy \n\n Untreated severe hypothyroidism, hyperthyroidism or adrenal insufficiency based on medical history \n\n ALT or AST elevations > 5 times upper limit of normal \n\n Biliary liver cirrhosis, history or presence of severe hepatic encephalopathy, ascites, esophageal variceal bleeding within the past three months, severe portal hypertension or surgical portosystemic shunt. \n\n Received any organ transplant, clinical diagnosis of pneumonia, symptomatic hyponatremia requiring urgent intervention or any concurrent illness which, in the opinion of the investigator, may interfere with treatment or evaluation of safety \n\n Pregnant or lactating \n\n Currently using vasopressin, oxytocin or desmopressin", - "brief_summary": "This study will evaluate the safety and effectiveness of Conivaptan, a vasopressin antagonist, in the treatment of hyponatremic subjects having symptomatic acute decompensated heart failure (ADHF).", - "NCTID": "NCT00843986" - }, - { - "brief_title": "LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin", - "phase": "", - "drugs": "['Enoxaparin']", - "drugs_list": [ - "Enoxaparin" - ], - "diseases": "['Coronary Artery Disease', 'Acute Myocardial Infarction']", - "diseases_list": [ - "Coronary Artery Disease", - "Acute Myocardial Infarction" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 to 80 \n\n Anterior myocardial infarction with: \n\n Pathological Q-waves in at least 3 contiguous anterior precordial leads, assumed to be new \n\n CK peak>5 times the upper limit of normal with positive MB bands \n\n Ejection fraction <=40% or anterior dyskinesis or documented LV Thrombus \n\n MI onset < 7 days from randomization \n\n ", - "exclusion_criteria": ": \n\n Inability to give written informed consent \n\n Medical conditions that would prohibit discharge within 48 hours with the exception of need for anticoagulation \n\n Cardiogenic shock, rest angina unresponsive to medical therapy or serious ventricular arrhythmia in the 24 hours prior to randomization \n\n Patients scheduled for surgical procedure in the next 4 months that would prevent use of enoxaparin or warfarin \n\n Anemia: Baseline Hgb<=9 gm for women, <=10 gm for men or platelet count<100,000 \n\n Renal insufficiency (creatinine >2.0 mg/dl) \n\n Serious liver disease as reflected by INR>1.3 \n\n Stroke within past 6 months or a prior documented intracranial or subarachnoid hemorrhage \n\n Active bleeding or major surgery within 2 weeks prohibiting the use of anticoagulants \n\n Acute pericarditis \n\n Women of childbearing potential unless pregnancy test negative \n\n Cardiac or non-cardiac condition with expected survival< 6 months \n\n Severe peripheral vascular disease \n\n Patients who undergo cardiac surgery, including CABG, as a result of their index myocardial infarction \n\n Allergy to aspirin, heparin or warfarin, pork or pork products \n\n History of recurrent thromboembolic disease or a history of Protein C, Protein S, antithrombin III deficiency or known bleeding disorder. \n\n Current use of warfarin or need for chronic anticoagulation \n\n Current participation in other trials using investigational drugs or devices \n\n Prior enrollment in this trial", - "brief_summary": "To prospectively evaluate the utility of enoxaparin vs. oral warfarin in reduction of echocardiographic indices of LV mural thrombus. The primary outcome is the presence of LV mural thrombus at 3.5 months. The secondary outcome is cost analysis comparing the two arms.", - "NCTID": "NCT00321009" - }, - { - "brief_title": "IMAGE-HF Project I-A: Cardiac Imaging in Ischemic Heart Failure (AIMI-HF)", - "phase": "", - "drugs": "['Advanced cardiac imaging', 'Standard Cardiac Imaging']", - "drugs_list": [ - "Advanced cardiac imaging", - "Standard Cardiac Imaging" - ], - "diseases": "['Heart Failure', 'Coronary Artery Disease', 'Ischemic Cardiomyopathy']", - "diseases_list": [ - "Heart Failure", - "Coronary Artery Disease", - "Ischemic Cardiomyopathy" - ], - "enrollment": "1390.0", - "inclusion_criteria": "inclusion criteria: \n\n Age >18 years \n\n Known or highly suspected coronary artery disease (CAD) documented by coronary angiography or by history of previous MI or evidence of moderate ischemia or scar based on prior imaging \n\n LV dysfunction most likely attributable to ischemic heart disease with EF <45% measured by any acceptable means (echo, nuclear RNA, PET or SPECT perfusion, Angiography, Cardiac MR) within the previous 6 months AND NYHA class II-IV symptoms within the past 12 months. \n\n OR \n\n LV dysfunction most likely attributable to ischemic heart disease with EF \u226430% measured by any acceptable means (echo, nuclear RNA, PET or SPECT perfusion, Angiography, Cardiac MR) within the previous 6 months AND NYHA class I within the past 12 months \n\n ", - "exclusion_criteria": ": \n\n Severe medical conditions that significantly affect the patient's outcome (eg. severe COPD, active metastatic malignancy) and would preclude revascularization. \n\n < 4 weeks post ST segment elevation myocardial infarction (STEMI) \n\n Already identified as not suitable for revascularization; \n\n Emergency revascularization indicated \n\n Severe valvular heart disease requiring surgery \n\n Contraindications to CMR (eg metallic implant, claustrophobia, renal failure (GFR <30 ml/min/1.73m2),). However patients with permanent pacemakers or implanted defibrillators or GFR <30 ml/min/1.7m2, will be randomized only to standard imaging (SPECT) versus PET or entered into the registry if only 1 modality is available \n\n Pregnancy \n\n Potential for non compliance to tests involved in this protocol \n\n Incapacity to provide informed consent", - "brief_summary": "Medical imaging is one of the fastest growing sectors in health care and increases in utilization underscore the need to ensure imaging technology is developed and used effectively. Evaluation of the clinical and economic impact of such imaging lags behind the technology development. Heart failure (HF) represents the final common pathway for most forms of heart disease and morbidity and mortality remain high. There is a need to identify imaging approaches that have a positive impact on therapy decisions, patient outcomes and costs. As well as standard methods to evaluate new and emerging techniques to better test their potential in a clinical management setting.~PRIMARY OBJECTIVES: to compare the effect of HF imaging strategies on the composite clinical endpoint of cardiac death, MI, resuscitated cardiac arrest and cardiac re-hospitalization (WHF, ACS, arrhythmia). Patients with an ischemic heart disease (IHD) etiology will follow HF imaging strategy algorithms according to the question(s) asked by the physicians (is there ischemia and/or viability), in agreement with their local practices for standard and alternative imaging.~SECONDARY OBJECTIVES:~To evaluate the effect of imaging modalities within and between the imaging subgroups (advanced (CMR and PET), PET, MRI and standard (SPECT)) on the primary and secondary outcomes in patients being evaluated either for viability and/or ischemia.~To evaluate the impact of adherence to recommendations between modalities on outcomes in patients being evaluated for either viability or ischemia.~To compare the effect of HF imaging strategies on:~The incidence of revascularization procedures (PCI, CABG, none) and the interaction of the imaging strategy and types of revascularization on outcomes~LV remodeling: LV volumes, LVEF,~HF symptoms, NYHA class~QOL (MLHFQ, the EQ5D)~The evolution of serum prognostic markers in HF (e.g. BNP, RDW, hs-cTnT, hs-CRP, ST2)~Health economics: Costs estimated through regression analysis and cost effectiveness assessed through decision modeling.~The safety of imaging tests measured by cumulative radiation, adverse reactions to imaging contrast agents and stress testing agents will also be determined.~The evolution of renal function (eGFR) and LV remodeling-associated biomarkers (e.g. PIIINP, OPN).~Event rates of each component of the composite endpoint as well as the combined endpoint of CV death and HF hospitalization~All-cause mortality", - "NCTID": "NCT01288560" - }, - { - "brief_title": "Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)", - "phase": "", - "drugs": "['Ezetimibe']", - "drugs_list": [ - "Ezetimibe" - ], - "diseases": "['Primary Hypercholesterolemia', 'Homozygous Familial Hypercholesterolemia']", - "diseases_list": [ - "Primary Hypercholesterolemia", - "Homozygous Familial Hypercholesterolemia" - ], - "enrollment": "4105.0", - "inclusion_criteria": "inclusion criteria: \n\n Outpatient men or women, age 18 years and above. \n\n Patients with primary (heterozygous familial and non-familial) hypercholesterolemia or homozygous familial hypercholesterolemia. \n\n ", - "exclusion_criteria": ": \n\n Known hypersensitivity to Ezetimibe. \n\n Moderate to severe hepatic insufficiency. \n\n Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal. \n\n Pregnancy or lactation. \n\n Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine", - "brief_summary": "The purpose of this study is to evaluate the overall safety, tolerability, and efficacy of Ezetimibe when used alone or in combination with a statin in patients with hypercholesterolemia", - "NCTID": "NCT00704535" - }, - { - "brief_title": "Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia", - "phase": "Phase 3", - "drugs": "['Fluvastatin']", - "drugs_list": [ - "Fluvastatin" - ], - "diseases": "['Heterozygous Familial Hypercholesterolemia', 'Mixed Dyslipidemia']", - "diseases_list": [ - "Heterozygous Familial Hypercholesterolemia", - "Mixed Dyslipidemia" - ], - "enrollment": "84.0", - "inclusion_criteria": "inclusion criteria: \n\n 10-16 years old Heterozygous familial hypercholesterolemia \n\n ", - "exclusion_criteria": ": \n\n Homozygous familial hypercholesterolemia Pregnant or lactating females Major surgery during the six month prior study \n\n Other protocol defined inclusion and ", - "brief_summary": "The purpose of the study is to assess the safety and efficacy of fluvastatin in children diagnosed with heterozygous familial hypercholesterolemia", - "NCTID": "NCT00171236" - }, - { - "brief_title": "The Effect of Granulocyte Colony Stimulating Factor (G-CSF) on Myocardial Function After Acute Anterior Myocardial Infarction, a Prospective Double Blind Randomized Placebo Controlled Study", - "phase": "", - "drugs": "['G-CSF', 'placebo infusion of normal saline']", - "drugs_list": [ - "G-CSF", - "placebo infusion of normal saline" - ], - "diseases": "['Myocardial Infarction']", - "diseases_list": [ - "Myocardial Infarction" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n First anterior myocardial infarction. \n\n Low systolic ventricular function. \n\n ", - "exclusion_criteria": ": \n\n Bleeding tendency \n\n Contraindication to G-CSF \n\n Cardiogenic shock \n\n Hemodynamic instability \n\n Hepatic or renal disease \n\n Multivessel disease", - "brief_summary": "The investigators applied G-CSF to patients 2 weeks after acute anterior MI and successful PCI to evaluate the efficacy and safety of G-CSF in improving myocardial function as cytokine which improve inflammation and mobilize stem cells from bone marrow for regeneration of myocardium.", - "NCTID": "NCT00756756" - }, - { - "brief_title": "COmbined N-acetylcysteine and Bicarbonate in PCI To Reduce Adverse Side Effect of contrasT", - "phase": "Phase 2; Phase 3", - "drugs": "['N-acetylcysteine', 'Sodium Bicarbonate']", - "drugs_list": [ - "N-acetylcysteine", - "Sodium Bicarbonate" - ], - "diseases": "['Contrast Induced Nephropathy']", - "diseases_list": [ - "Contrast Induced Nephropathy" - ], - "enrollment": "477.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 21 year \n\n Glomerular Filtration Rate (GFR) 15-60ml/min calculated by MDRD formula \n\n Scheduled to undergo elective PCI \n\n Able to receive 12 hours of pre-hydration \n\n Written informed consent \n\n ", - "exclusion_criteria": ": \n\n GFR less than 15ml/min or patients diagnosed with end stage renal failure \n\n Increase in serum creatinine levels of > 0.5mg/dl or 44umol/l in the previous 24 hours \n\n Preexisting dialysis \n\n Pulmonary edema or moderate to severe congestive heart failure (New York Heart \n\n Association [NYHA] III-IV) \n\n Patient unable to withstand the fluid load and hemodynamics compromise \n\n Uncontrolled hypertension (untreated systolic blood pressure > 160 mmHg, or diastolic blood pressure > 100mmHg.) \n\n Emergency cardiac catheterization (i.e. patient presenting with ST segment elevation myocardial infarction undergoing primary angioplasty) \n\n Recent exposure to radiographic contrast (within two days of the study). \n\n Allergic to radio-contrast \n\n Administration of sodium bicarbonate solution or NAC within 48 hours before the PCI. \n\n Patient unable to give consent \n\n Clinically vulnerable condition requiring continuous fluid therapy e.g. severe sepsis \n\n Use of NSAID, aminoglycocide, cyclosporin, cysplatin within 48 hours prior to PCI and throughout the study duration", - "brief_summary": "This is a randomised controlled trial to investigate the efficacy of preventive regimen of hydration with high dose oral N-acetylcysteine and intravenous sodium bicarbonate pretreatment in patients with stable advanced renal insufficiency (CKD stage 3 and 4:GFR 15-60ml/min/1.73m2 calculated by Modification of Diet in Renal Disease Study equation (MDRD formula)) undergoing elective percutaneous coronary intervention (PCI).", - "NCTID": "NCT00497328" - }, - { - "brief_title": "Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients (Study P05647)", - "phase": "", - "drugs": "['Vytorin (R) (Ezetimibe + Simvastatin)']", - "drugs_list": [ - "Vytorin (R) (Ezetimibe + Simvastatin)" - ], - "diseases": "['Hypercholesterolemia']", - "diseases_list": [ - "Hypercholesterolemia" - ], - "enrollment": "4748.0", - "inclusion_criteria": "inclusion criteria: \n\n Outpatient men or women, age 18 years and above \n\n Patients with primary (heterozygous familial and non-familial) hypercholesterolemia \n\n ", - "exclusion_criteria": ": \n\n Known hypersensitivity to Ezetimibe and Simvastatin \n\n Moderate to severe hepatic insufficiency \n\n Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal \n\n Pregnancy or lactation \n\n Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine", - "brief_summary": "This study aims to establish the safety, tolerability, and efficacy of Vytorin (R) (Ezetimibe + Simvastatin) (SCH 465981) on a select population of Filipinos with hypercholesterolemia.", - "NCTID": "NCT00909389" - }, - { - "brief_title": "Chest Ultrasound of ER Patients With Cough or SOB", - "phase": "", - "drugs": "['Nuvis Diagnostic Ultrasound System']", - "drugs_list": [ - "Nuvis Diagnostic Ultrasound System" - ], - "diseases": "['Cough', 'Dyspnea', 'Wheezing']", - "diseases_list": [ - "Cough", - "Dyspnea", - "Wheezing" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Presenting to the Emergency Department with cough, wheezing and/or dyspnea (shortness of breath) \n\n Referred for CXR and/or CT scan \n\n ", - "exclusion_criteria": ": \n\n Life threatening medical condition requiring immediate treatment \n\n Unable to sit up for a chest ultrasound \n\n Unable to consent \n\n Pregnant \n\n Unable to speak, read and write in English", - "brief_summary": "Acute dyspnea (shortness of breath) is a common complaint for patients presenting to the Emergency Department (ED). The chest radiograph (CXR) has been the mainstay in evaluating patients with shortness of breath and often provides the timely diagnosis of pneumonia, pneumothorax, pulmonary edema, among other primary diseases of the lung. There are limitations with chest radiograph such as large body mass (e.g, obesity) and patient positioning. On occasion, chest radiography findings are difficult to interpret. Lung ultrasonography may offer a means of clarifying ambiguous results.~The objective of this study to determine the usefulness of point of care lung ultrasound in evaluating patients presenting to the ED with shortness of breath, cough and/or wheezing.", - "NCTID": "NCT02269761" - } - ], - "1": [ - { - "brief_title": "Right Ventricular Apical Versus True Mid-septal Pacing", - "phase": "Phase 4", - "drugs": "['Pacing site - the implantation in the right ventricular (RV) apex', 'Pacing site - the implantation in the septum']", - "drugs_list": [ - "Pacing site - the implantation in the right ventricular (RV) apex", - "Pacing site - the implantation in the septum" - ], - "diseases": "['Ventricular Rhythm From Artificial Pacing']", - "diseases_list": [ - "Ventricular Rhythm From Artificial Pacing" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Indication for cardiac pacing. \n\n ", - "exclusion_criteria": ": \n\n renal insufficiency \n\n iod allergy \n\n claustrophobia \n\n significant valvular disease \n\n recent acute coronary syndrome \n\n planned cardiac surgery \n\n ejection fraction of left ventricle less than 50% \n\n live expectancy less than 3 years \n\n expected non-compliance of the patient", - "brief_summary": "Background Right ventricular (RV) artificial apical pacing can negatively impact synchrony of left ventricular contraction. The pacing from the septum of the RV can present an advantage in terms of less expressed dyssynchrony and reduced negative impact on left ventricular (LV) function. However, results of randomized studies comparing apical and septal pacing are not uniform. All these results have been affected by improper implantation of the septal lead, with many apparently septal leads being, in fact, implanted off-septum. The aim of the study is to compare true septal pacing with other RV pacing locations.~Methods/Design This is a prospective, randomized, single center study. Patients with standard indications for cardiac pacing with the expectation of high percentage RV pacing will be enrolled. They will be randomized into apical and septal pacing. The real location of leads in patients randomized to septal pacing will be confirmed using cardiac CT. After cardiac CT, three groups of patients will be created: 1) apical pacing, 2) true septal (in which the position of the lead has been verified to be in the septum), and 3) apparent septal (in which the position of the lead was found to be off-septum). Primary end-point are changes in standard echocardiographic parameters (LV ejection fraction, LV end-systolic volume, and LV end-diastolic volume) and the concentration of N-terminal pro brain natriuretic peptide (NT-proBNP) from baseline to 6 months, 1 year and three years. Secondary end-points are changes in echo-parameters of LV synchrony.~Discussion It is hypothesized that correct septal pacing will be associated with reduce negative impact on the function of the left ventricle (i.e. smaller decreases in LV EF and smaller increases in LVEDV, LVESV) and NT-proBNP, and less expressed LV dyssynchrony.", - "NCTID": "NCT02412176" - }, - { - "brief_title": "Renal Stent Placement for the Treatment of Renal Artery Stenosis in Patients With Resistant Hypertension", - "phase": "", - "drugs": "['iCAST\u2122 Rx Stent System']", - "drugs_list": [ - "iCAST\u2122 Rx Stent System" - ], - "diseases": "['Renal Artery Stenosis', 'Hypertension, Renovascular']", - "diseases_list": [ - "Renal Artery Stenosis", - "Hypertension", - "Renovascular" - ], - "enrollment": "68.0", - "inclusion_criteria": "General inclusion criteria: \n\n Age \u2265 18 at the time of informed consent. \n\n Subject or subject's legal representative have been informed of the nature of the trial, agrees to participate, and has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF). \n\n Subjects that have bilateral kidneys or a solitary functioning kidney with Renal Artery Stenosis in at least one kidney and an average Systolic Blood Pressure (SBP) \u2265 155mmHg. \n\n Subject has a history of maximum tolerable dose of \u2265 3 anti-hypertensive medications of different classes, one of which must be a diuretic (for at least two weeks prior to Medical Documentation Screening period). \n\n a. A documented history for a minimum of 3 months showing reasonable and aggressive efforts to manage hypertension prior to consent. This must include the use of a broad variety of medications that have been used and failed or not tolerated. \n\n Subject must have documented clinical evidence to support likelihood of angiographic findings > 80% whether it is DUS, CTa, MRa or other medical evidence. \n\n New York Heart Association (NYHA) class I, II, or III the time of trial enrollment. \n\n Note: When a subject has bilateral Renal Artery Stenosis both of which require stenting, it is recommended to treat both kidneys with an iCAST\u2122 RX Stent System during the index procedure. In the event that a subject needs a renal stenting procedure staged for renal protection, it is important that the Investigator treats the second renal artery with an iCAST\u2122 RX Stent System after 30 days of the index procedure. If subjects with bilateral stenosis have only one lesion that meets protocol inclusion criteria that lesion should be treated per protocol. The recommendation is to NOT treat the second non-qualifying lesion, however if the operator feels strongly it is indicated, then they should treat per standard of care after 30-days post index procedure in order to comply with ", - "exclusion_criteria": " #10. \n\n Subjects with flash pulmonary edema are allowed into the trial should they meet all other Inclusion and ", - "brief_summary": "The purpose of this trial is to test how well the iCAST\u2122 RX Stent works in patients diagnosed with atherosclerotic renal artery stenosis and whether or not increased blood flow by the stent will help to control blood pressure.", - "NCTID": "NCT01673373" - }, - { - "brief_title": "Amlodipine/Atorvastatin (Caduet\u00ae) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)", - "phase": "", - "drugs": "['Amlodipine/Atorvastatin']", - "drugs_list": [ - "Amlodipine/Atorvastatin" - ], - "diseases": "['Hypertension', 'Angina Pectoris', 'Hypercholesterolemia', 'Familial Hypercholesterolemia']", - "diseases_list": [ - "Hypertension", - "Angina Pectoris", - "Hypercholesterolemia", - "Familial Hypercholesterolemia" - ], - "enrollment": "1291.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or Female subjects intend to treat their cardiovascular disease who are prescribed Amlodipine /Atorvastatin (Caduet\u00ae) Combination Tablets by their Physicians \n\n ", - "exclusion_criteria": ": \n\n Subjects who have been prescribed Amlodipine /Atorvastatin (Caduet\u00ae) Combination Tablets before.", - "brief_summary": "In this survey, to collect the safety and efficacy information of Amlodipine /Atorvastatin (Caduet\u00ae Combination Tablets) in daily medical practice will be examined. In addition, the necessity of special Investigation and post-marketing clinical studies will be examined, while investigating unexpected adverse drug reactions during the survey period and understanding of the status of frequency of adverse drug reactions in daily medical practice.", - "NCTID": "NCT01107743" - }, - { - "brief_title": "An Epidemiological Study Aimed to Record Standard Daily Practice in Managing Patients With Hypercholesterolemia", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Hypercholesterolemia']", - "diseases_list": [ - "Hypercholesterolemia" - ], - "enrollment": "330.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with hypercholesterolemia currently receiving a lipid lowering agent \n\n ", - "exclusion_criteria": ": \n\n Pregnancy and lactation.", - "brief_summary": "This study is aimed to collect the following Serbia-specific epidemiology data on hypercholesterolemia: patents characteristics, patients' management/treatment and physicians' standard practice. In addition, the aim is to determine the proportion of patients on lipid-lowering pharmacological treatment who have reached the LDL-C and HDL-C treatment goals.", - "NCTID": "NCT01206231" - }, - { - "brief_title": "Polish Survey on the Efficacy of the Hypercholesterolemia Treatment", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Hypercholesterolemia']", - "diseases_list": [ - "Hypercholesterolemia" - ], - "enrollment": "1500.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients on lipid lowering drug treatment \n\n Lipid lowering drug treatment lasting at least 3 months \n\n No lipid lowering drug/dose change for a minimum 6 weeks prior to enrolment to the study \n\n ", - "exclusion_criteria": ": \n\n Lack of patient's signed informed consent form \n\n Lack of the blood sample taken for lipid profile and glucose within 10 days before or after assessment of the patient", - "brief_summary": "The purpose of the survey is to evaluate the efficacy of treatment of hypercholesterolemia in Polish patients who are currently on lipid- lowering pharmacological therapy . Efficient treatment is defined as achievement of the LDL cholesterol level goals according to the European Society of Cardiology 2007 guidlines.", - "NCTID": "NCT01243255" - } - ], - "2": [ - { - "brief_title": "Safety of 6-month Duration of Dual Antiplatelet Therapy After Acute Coronary Syndromes (SMART-DATE)", - "phase": "", - "drugs": "['P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)']", - "drugs_list": [ - "P2Y12 inhibitor (clopidogrel", - "ticagrelor", - "prasugrel)" - ], - "diseases": "['Acute Coronary Syndrome']", - "diseases_list": [ - "Acute Coronary Syndrome" - ], - "enrollment": "2712.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject must be \u2265 20 years. \n\n Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving percutaneous coronary intervention and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. \n\n Subject must have a culprit lesion in a native coronary artery with significant stenosis (>50% by visual estimate) eligible for stent implantation. \n\n Subject must have clinical diagnosis of ACS that includes unstable angina and MI. The specific definitions of ACS, as follows; 1) ST-segment elevation MI (STEMI) : elevation of ST-segment more than 0.1 mV in 2 or more contiguous electrocardiographic (ECG) leads or new left bundle-branch block with elevated biomarkers of myocardial necrosis 2) Non-ST-segment elevation MI (NSTEMI) : Elevated biomarkers of myocardial necrosis (troponin or CK-MB > upper reference limit) with one of the following; (a) Transient ST-segment elevation or depression, or T-wave changes consistent with myocardial ischemia, (b) Identification of a culprit lesion at coronary angiography 3) Unstable angina : An accelerating pattern or recurrent episodes of chest pain at rest or with minimal effort and new ST-segment depression of at least 0.05 mV, or T wave inversion of at least 0.3 mV in at least 2 leads. The ECG criteria for unstable angina were based on the TACTICS-TIMI 18 trial. \n\n Target lesion(s) must be located in a native coronary artery with visually estimated diameter of \u2265 2.25 mm and \u2264 4.25 mm. \n\n Target lesion(s) must be amenable for percutaneous coronary intervention \n\n ", - "exclusion_criteria": ": \n\n The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Biolimus, Everolimus, Zotarolimus, and Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.) \n\n Patients with active pathologic bleeding \n\n Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months. \n\n Systemic (intravenous) Biolimus, everolimus, zotarolimus use within 12 months. \n\n Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study. \n\n History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions \n\n Noncardiac comorbid conditions are present with life expectancy <1 year or that may result in protocol noncompliance (per site investigator's medical judgment). \n\n An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first 12 months post enrollment. \n\n Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.", - "brief_summary": "Objective : To test the safety of 6 month-duration of dual antiplatelet therapy (DAPT) compared to conventional 12-month-or-longer duration after second-generation drug-eluting stent (DES) implantation in patients with acute coronary syndrome (ACS).~Hypothesis : A 6-month duration of DAPT is non-inferior to a conventional 12-month-or longer duration of DAPT at preventing the occurrence of major adverse cardiac and cerebrovascular events (MACCE) at 18-month after second-generation DES implantation in patients with ACS.", - "NCTID": "NCT01701453" - }, - { - "brief_title": "Vascular Endothelial Growth Factor (VEGF), Platelet Derived Growth Factor (PDGF), Hepatocyte Growth Factor (HGF) in Patients With Acute Coronary Syndrome (ACS)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Acute Coronary Syndrome']", - "diseases_list": [ - "Acute Coronary Syndrome" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n typical chest pain; \n\n ST segment elevation or depression in ECG; \n\n indication for coronary angiography; if necessary with PCI and 4) signed inform consent. \n\n ", - "exclusion_criteria": ": \n\n known past history of a myocardial infarction; \n\n not signed informed consent.", - "brief_summary": "The main aim of the study is a comparison of serum and plasma concentration of VEGF (Vascular Endothelial Growth Factor), HGF (Hepatocyte Growth Factor) and PDGF (Platelet Derived Growth Factor) with markers of myocardial injury as troponin I, hsCRP, CK-MB and NT-proBNP assessed in patients with first episode of acute coronary syndrome (ACS) in their lives and the estimation of assumed value of VEGF, HGF and PDGF in prognosis of cardiovascular complications at 3 months follow up especially with respect to myocardial infarction (MI), exacerbation of angina, reintervention (PTCA,CABG), symptoms of heart failure, stroke, rehospitalization due to cardiovascular reasons and death. The dynamics of changes in serum and plasma concentration of growth factors in comparison with values of myocardial injury markers will be checked. For the realization of the purpose of the study biochemical measurements will be performed twice i.e. just after admission to hospital and 24h later. Area of a myocardial injury will be estimated by echocardiography examination.", - "NCTID": "NCT00844987" - }, - { - "brief_title": "Trial of a Cardiac Rehabilitation Program Delivered Remotely Through the Internet", - "phase": "", - "drugs": "['vCRP']", - "drugs_list": [ - "vCRP" - ], - "diseases": "['Cardiovascular Disease']", - "diseases_list": [ - "Cardiovascular Disease" - ], - "enrollment": "79.0", - "inclusion_criteria": "inclusion criteria: \n\n Men and women admitted for an IHD event (acute coronary syndrome or revascularization procedure) who are at low or moderate risk.91 \n\n Regular Internet access (home, work or other environment). \n\n Over 18 years of age. \n\n Permission of the attending physician. \n\n Able to read, write and understand English without difficulty. \n\n No physical limitations to regular activity. \n\n ", - "exclusion_criteria": ": \n\n Previous experience with a cardiac rehabilitation program. \n\n Patients with depression, uncontrolled diabetes and other significant co-morbidities that may interfere with effective IHD management. \n\n Those patients, who in the mind of the attending physician, are unsuitable for participation. \n\n Those unable to provide informed consent. \n\n Pregnant women. \n\n High-risk patients for safety considerations (future studies will include high-risk patients).", - "brief_summary": "Cardiac rehabilitation programs (CRP) are a proven treatment for those with ischemic heart disease (IHD). These programs have been demonstrated to improve adherence to regular physical activity, a healthy diet and smoking cessation, as well as modify risk factors for IHD such as hypercholesterolemia, hypertension, obesity and type 2 diabetes. In addition, CRP are cost effective and can result in a 25% reduction in reoccurrence of mortality. Despite the known benefits of CRP, as little as 10% to 25% of eligible patients attend these programs. One of the main barriers to attendance is proximity to a CRP, as the majority of these programs are limited to hospitals in large urban areas. However, cardiovascular diseases do not discriminate by geography, resulting in a geographic inequity of care for patients living in rural, remote and smaller urban/sub-urban centres. Currently there are no CRP specifically designed for patients in rural and remote areas. The use of the Internet may present itself as a viable alternative. We have recently completed a pilot study of a virtual CRP (vCRP) that demonstrated significant improvements in exercise capacity and risk factors. This investigation will study the vCRP in a group of IHD patients who do not have access to hospital-based CRP.~Hypotheses A. Participation in a 4 month Internet-based cardiac rehabilitation program will result in significant improvements in exercise capacity compared to usual care, in patients with diagnosed IHD.~B. Participation in a 4 month Internet-based cardiac rehabilitation program will result in significant improvements in exercise capacity after one year compared to usual care, in patients with diagnosed IHD.~Study Population Men and women over 18 years will be identified from consecutive in-patients of the British Columbia Provincial Heart Centre at St. Paul's Hospital in Vancouver who reside in either the Northern Interior or Coast Garibaldi health areas. Patients will be eligible if they have IHD, Internet access, no previous experience with cardiac rehabilitation and no physical limitations to exercise. A total of 74 patients (37 per group) will be recruited and randomized to either usual care, or a 4 month 'virtual' cardiac rehabilitation program delivered via the Internet.~Usual Care Group Patients randomized to usual care will be provided with simple guidelines for safe exercising and healthy eating habits, and return to the care of their primary care physician. Patients will return at 4 and 16 months later for outcome assessment. There will be no contact between the study personnel and usual care patients for the duration of the study, nor will there be any attempt to control the level of patient care.~Intervention The vCRP has been developed to mimic hospital-based CRP and includes online intake forms, one-on-one chat sessions with vCRP nurse, dietitian and exercise specialist, data collection (exercise heart rate, blood pressure, glucose- if diabetic), peer-support group chat sessions, ask-an-expert chat sessions, education, progress reports and online resources. Upon randomization to the intervention, patients will receive access to the website, a heart rate monitor and a blood pressure monitor and trained in their use. The heart rate monitors allow for exercise heart rate data to be stored and downloaded to their home computer and then uploaded to the vCRP webserver. The exercise data will be reviewed weekly. A letter to the patient's primary care physician will be sent to outline the vCRP intervention, the treatment algorithms to be used and indicate under what circumstances the vCRP nurse and/or patient may contact them with regards to their management. Patients will receive one-on-one counselling by the nurse, dietitian and exercise specialist via chat sessions at 3 to 4 week intervals. After the 4 month intervention, patients will be discharged into the care of their primary care physician.~Outcomes Participants will be assessed at baseline, 4 and 16 months for risk factors and lifestyle behaviours. The primary outcomes will be the change in exercise capacity as between the two groups from baseline to 4 months, and from baseline to 16 months. Exercise capacity will be assessed as total time on a symptom-limited exercise stress test.", - "NCTID": "NCT00683813" - } - ] - }, - { - "patient_id": "sigir-20155", - "patient": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", - "0": [ - { - "brief_title": "Massage Therapy in Juvenile Idiopathic Arthritis", - "phase": "", - "drugs": "['Massage therapy', 'Standard care']", - "drugs_list": [ - "Massage therapy", - "Standard care" - ], - "diseases": "['Juvenile Idiopathic Arthritis']", - "diseases_list": [ - "Juvenile Idiopathic Arthritis" - ], - "enrollment": "6.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of JIA (ILAR classification) \n\n Age 5 to 17 years \n\n Ability to speak/read French or English; one caregiver per child will be recruited; \n\n Presence of pain, defined as: pain reported by the child and/or caregiver, and/or joint tenderness and/or stress pain in at least 1 joint during physical examination performed by rheumatologist. Pain reported by the child/caregiver is not a prerequisite because some children develop behaviors and guarding postures to avoid pain \n\n Absence of anticipated change in treatment. If, during the study, a change in treatment is necessary, the change will be recorded but the child will not be withdrawn \n\n Stable dosages of medications and absence of intra-articular corticosteroid injections for 4 weeks prior to enrolment \n\n Eligibility confirmed by child's rheumatologist. \n\n ", - "exclusion_criteria": ": \n\n No current MT \n\n Systemic arthritis with quotidian fevers \n\n Acute infection \n\n Open skin lesion \n\n Fibromyalgia \n\n Sleep apnea \n\n Medications: anticoagulants, muscle relaxants, analgesic medications (acetaminophen allowed) \n\n Pregnancy.", - "brief_summary": "While there has been progress in juvenile idiopathic arthritis (JIA) management, there is no cure. Despite receiving standard of care, many children live with pain. Thus, it is not surprising that families turn to complementary and alternative medicines (CAM) therapies, including massage therapy (MT). Little is known about the efficacy of MT in JIA.~In this project, a massage therapist will teach parents how to provide a massage to their child with JIA at bedtime, at home. The feasibility of establishing a home MT program for children with JIA will be evaluated. In addition, the effects of MT on JIA will be examined.~This proposal is relevant to JIA families, who ask questions on MT to professionals of the JIA clinic.~Beyond providing education to JIA families, this project demonstrates the team approach to JIA management. Team members will include a pediatric rheumatology nurse and a massage therapist.", - "NCTID": "NCT02218580" - }, - { - "brief_title": "Resilience for Older Workers With OA Through Exercise", - "phase": "", - "drugs": "['Exercise', 'No Exercise']", - "drugs_list": [ - "Exercise", - "No Exercise" - ], - "diseases": "['Osteoarthritis, Knee', 'Osteoarthritis, Hip']", - "diseases_list": [ - "Osteoarthritis", - "Knee", - "Osteoarthritis", - "Hip" - ], - "enrollment": "24.0", - "inclusion_criteria": "inclusion criteria: \n\n 45 years of age or older \n\n McMaster employee \n\n Sedentary job (stand or walk for <1/3 of work day) \n\n Able to safely climb two flights of stairs \n\n Hip pain \n\n Hip pain during internal rotation and hip flexion \n\n Knee pain \n\n Less than 30 minutes of morning stiffness in the knee \n\n Crepitus in the knee with active range of motion \n\n Bony enlargement around the knee \n\n Bony tenderness to palpation at the knee \n\n No warmth around the knee \n\n ", - "exclusion_criteria": ": \n\n Any other forms of arthritis \n\n Osteoporosis-related fracture \n\n History of patellofemoral symptoms \n\n Active non-arthritic hip or knee disease \n\n Hip or knee surgery \n\n Use of cane or walking aid \n\n Unstable heart condition \n\n Neurological conditions \n\n Hip, knee or ankle injuries in past 3 months \n\n Physician-advised restriction to physical activity \n\n Any injuries that would prohibit participation in exercise \n\n Ipsilateral ankle conditions \n\n Currently receiving cancer treatment \n\n Currently pregnant", - "brief_summary": "Exercise is effective at reducing pain while improving physical function. However we do not know if exercise can boost resilience in the workplace, to allow people with osteoarthritis to work as long as they desire. Previous research shows that exercise holds the most promise for helping people enjoy their work because it reduces sick time, reduces pain, and improves productivity. However, little work has examined the effect of exercise for people with arthritis in the workplace. The purpose of the study is to investigate whether exercise improves resilience in the workplace, mobility, fitness, strength, and pain in comparison to no exercise in those with knee and/or hip osteoarthritis.", - "NCTID": "NCT02609672" - }, - { - "brief_title": "Survey of Osteoarthritis Real World Therapies (MK-0663-140)", - "phase": "", - "drugs": "['Standard of care for treatment of osteoarthritis (OA) of knee(s)']", - "drugs_list": [ - "Standard of care for treatment of osteoarthritis (OA) of knee(s)" - ], - "diseases": "['Osteoarthritis']", - "diseases_list": [ - "Osteoarthritis" - ], - "enrollment": "1261.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of primary osteoarthritis of the knee(s) \n\n Presently receiving prescribed oral or topical analgesics for a minimum duration of two weeks prior to enrollment \n\n ", - "exclusion_criteria": ": \n\n Arthritis other than primary osteoarthritis \n\n Treatment with disease-modifying antirheumatic drugs (DMARDS), methotrexate or biologics \n\n Subtotal or total joint replacement in the affected knee \n\n Chronic severe pain of other causes that in the opinion of the investigator may require long-term analgesia or confound the present study \n\n Currently enrolled in a clinical trial or who have participated in a clinical trial within the past 30 days", - "brief_summary": "This was a study to estimate the proportion of participants with osteoarthritis of the knee(s) who were treated with oral or topical analgesics for their symptoms, who did and did not report adequate pain relief at Baseline and to characterize their pain level over a 12-month follow-up period.", - "NCTID": "NCT01294696" - }, - { - "brief_title": "Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy", - "phase": "", - "drugs": "['Walk with Ease']", - "drugs_list": [ - "Walk with Ease" - ], - "diseases": "['Joint Pain', 'Breast Cancer']", - "diseases_list": [ - "Joint Pain", - "Breast Cancer" - ], - "enrollment": "78.0", - "inclusion_criteria": "inclusion criteria: \n\n Taking an aromatase inhibitor as adjuvant treatment for State I, II, or II breast cancer for at least 4 weeks \n\n Experiencing more than mild joint pain/symptoms \n\n 21 or older \n\n have permission from physician to engage in moderate intensity physical activity \n\n ", - "exclusion_criteria": ": \n\n Undergoing chemotherapy and/or radiation therapy at any time during the study period \n\n Scheduled for major surgery during the study period \n\n Presently engaged in high levels of physical activity on a daily basis \n\n Less than 21 years of age \n\n Unable to walk or engage in moderate intensity physical activity", - "brief_summary": "For post-menopausal women diagnosed with hormone-receptor positive breast cancer tumors, aromatase inhibitors (AIs) are the standard adjuvant hormone treatment to prolong disease-free survival and time-to-recurrence. Unfortunately, joint pain/stiffness/achiness (arthralgia) is a common side-effect of AIs. This proof-of-concept study explores how an evidence-based physical activity (PA) program- the Arthritis Foundation's Walk with Ease (WWE) program- can be adapted for breast cancer survivors on AI therapy to: 1) Help them maintain or achieve recommended levels of PA, 2) reduce their joint pain/stiffness/achiness, and 3) thereby enable them to remain on AI therapy as prescribed.", - "NCTID": "NCT01900418" - }, - { - "brief_title": "Platelet-Rich Plasma vs Corticosteroid Injection as Treatment for Degenerative Pathology of the Temporomandibular Joint", - "phase": "Phase 1", - "drugs": "['Group A (corticosteroid injection group)', 'Group B (platelet rich plasma injection group)']", - "drugs_list": [ - "Group A (corticosteroid injection group)", - "Group B (platelet rich plasma injection group)" - ], - "diseases": "['Degenerative Joint Disease']", - "diseases_list": [ - "Degenerative Joint Disease" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: The following diagnostic criteria for patient selection are to be used: \n\n Patients will need to have a history of chronic pain (at least 3 months) refractory to conservative therapy with non-steroidal anti-inflammatory medications, muscle relaxants, diet modifications and splint therapy \n\n Patients will also need to have imaging findings (radiography or magnetic resonance imaging) that show mild to severe degenerative changes of the temporomandibular joint \n\n ", - "exclusion_criteria": ": ", - "brief_summary": "1.0 BACKGROUND AND HYPOTHESES~1.1 Osteoarthritis is a continuous and entirely physiologic adaptive process that occurs in every joint. These include the replication of cells that produce matrix, enzymes, protease inhibitors, cytokines, and other peptides. Along with the synthesis of new tissue there is a release of breakdown products into the synovial fluid. Enzymes and phagocytes are required to clear these breakdown products. Normal tissue turnover involves synthesis and breakdown in well-regulated balance. In the degenerative state this balance is upset producing inflammation-derived alterations to the synovium, cartilage, capsule, tendons, and bone. Common causes of such alterations include increased loading, physical stress, and traumatic injury to the joint.~1.2 The rationale for the use of corticosteroids in temporomandibular joint therapy is that they inhibit prostaglandin synthesis and decrease the activity of collagenase and other enzymes that degrade the articular cartilage. Platelet rich plasma is a novel therapeutic agent that has several potential advantages over corticosteroids for the treatment of degenerative pathology of the temporomandibular joint. Platelet rich plasma has been shown to have anti-inflammatory, analgesic, and anti-bacterial properties. It also restores intra-articular hyaluronic acid, increases glycosaminoglycan condrocyte synthesis, balances joint angiogenesis, and provides a scaffold for stem cell migration. Autologous platelet rich plasma injections for treatment of knee cartilage degenerative lesions and osteoarthritis have shown longer efficacy than hyaluronic acid injections in reducing pain and recovering articular function. Similarly, platelet rich plasma has shown to have better outcomes than corticosteroid injections in the management of lateral epicondylitis, and better outcomes than hyaluronic acid injections in the management of osteochondral lesions of the talus.~1.3 Current treatments for degeneration and osteoarthritis of the temporomandibular joint are focused primarily on palliation by reducing inflammation and inflammatory mediators. This study seeks to validate a therapeutic agent that has the potential to actively prevent the progression of degeneration in addition to reducing pain and inflammation", - "NCTID": "NCT01920373" - }, - { - "brief_title": "Perioperative Flare in RA: Characterization of Clinical and Biological Features", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Rheumatoid Arthritis']", - "diseases_list": [ - "Rheumatoid Arthritis" - ], - "enrollment": "162.0", - "inclusion_criteria": "inclusion criteria: \n\n Age >18 \n\n Patients with Rheumatoid Arthritis undergoing total joint replacement surgery \n\n Satisfy American College of Rheumatology(ACR)/European League Against Rheumatism(EULAR) 2010 classification criteria and/or the 1987 RA criteria (see below) and be diagnosed with RA \n\n For control subjects: Have OA(Osteoarthritis), SLE(Systemic lupus erythematosus) or other inflammatory arthritis. \n\n ", - "exclusion_criteria": ": \n\n Diagnosis of any other systemic rheumatic disease \n\n Diagnosis of or crystalline arthropathy. \n\n Unable to understand or read English. \n\n Unable to follow the study protocol in a reliable manner. \n\n Age < 18 or >75. \n\n EXPLANATION OF CRITERIA: \n\n Rheumatoid arthritis 1987 criteria: \n\n morning stiffness in and around joints lasting at least 1 hour before maximal improvement; \n\n soft tissue swelling (arthritis) of 3 or more joint areas observed by a physician; \n\n swelling (arthritis) of the proximal interphalangeal, metacarpophalangeal, or wrist joints; \n\n symmetric swelling (arthritis); \n\n rheumatoid nodules; \n\n the presence of rheumatoid factor; and \n\n radiographic erosions and/or periarticular osteopenia in hand and/or wrist joints. \n\n Criteria 1 through 4 must have been present for at least 6 weeks. Rheumatoid arthritis is defined by the presence of 4 or more criteria, and no further qualifications (classic, definite, or probable) or list of exclusions are required. \n\n ACR/EULAR 2010 criteria for the classification of RA: \n\n Table 3. The 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis \n\n Target population (Who should be tested?): Patients who \n\n have at least 1 joint with definite clinical synovitis (swelling)* \n\n with the synovitis not better explained by another disease \n\n Classification criteria for RA (score-based algorithm: add score of categories A-D; \n\n a score of \u22656/10 is needed for classification of a patient as having definite RA \n\n Score \n\n A. Joint involvement \n\n 1 large joint 0 \n\n 2-10 large joints 1 \n\n 1-3 small joints (with or without involvement of large joints) 2 \n\n 4-10 small joints (with or without involvement of large joints) 3 \n\n >10 joints (at least 1 small joint) 5 \n\n B. Serology (at least 1 test result is needed for classification) \n\n Negative RF and negative ACPA 0 \n\n Low-positive RF or low-positive ACPA 2 \n\n High-positive RF or high-positive ACPA 3 \n\n C. Acute-phase reactants (at least 1 test result is needed for classification) \n\n Normal CRP and normal ESR 0 \n\n Abnormal CRP or abnormal ESR 1 \n\n D. Duration of symptoms \n\n < 6 weeks 0 \n\n 6 weeks 1 \n\n The criteria are aimed at classification of newly presenting patients. In addition, patients with erosive disease typical of rheumatoid arthritis (RA) with a history compatible with prior fulfillment of the 2010 criteria should be classified as having RA. Patients with longstanding disease, including those whose disease is inactive (with or without treatment) who, based on retrospectively available data, have previously fulfilled the 2010 criteria should be classified as having RA.", - "brief_summary": "Researchers at the Hospital for Special Surgery are trying to learn more about post-operative rheumatoid arthritis flare (RA). This study hopes to understand RA flare after total joint replacement surgery and what the result of flaring is for patients over the 6 weeks post operation.~Through this study we aim to describe rates, characteristics, and risk factors of RA flare within 6 weeks of total hip arthroplasty (THA) and total knee arthroplasty (TKA)", - "NCTID": "NCT02111057" - }, - { - "brief_title": "Zimmer POLAR - Total Knee Arthroplasty (TKA)", - "phase": "", - "drugs": "['Zimmer Persona Total Knee System']", - "drugs_list": [ - "Zimmer Persona Total Knee System" - ], - "diseases": "['Polyarthritis', 'Osteoarthritis', 'RheumatoId Arthritis', 'Traumatic Arthritis']", - "diseases_list": [ - "Polyarthritis", - "Osteoarthritis", - "RheumatoId Arthritis", - "Traumatic Arthritis" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient 18-75 years of age, inclusive; \n\n Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following: \n\n rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; \n\n collagen disorders and/or avascular necrosis of the femoral condyle; \n\n post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; \n\n moderate valgus, varus, or flexion deformities; \n\n the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee; \n\n Patient has participated in a study-related Informed Consent process; \n\n Patient is willing and able to complete scheduled study procedures and follow-up evaluations; \n\n Independent of study participation, patient is a candidate for commercially available Persona fixed bearing knee components implanted in accordance with product labeling. \n\n ", - "exclusion_criteria": ": \n\n Patient is currently participating in any other surgical intervention studies or pain management studies; \n\n Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint; \n\n Insufficient bone stock on femoral or tibial surfaces; \n\n Skeletal immaturity; \n\n Neuropathic arthropathy; \n\n Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb; \n\n Stable, painless arthrodesis in a satisfactory functional position; \n\n Severe instability secondary to the absence of collateral ligament integrity; \n\n Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin; \n\n Patient has a known or suspected sensitivity or allergy to one or more of the implant materials; \n\n Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.); \n\n Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.", - "brief_summary": "The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance measured by pain and function, quality of life data, radiographic parameters and survivorship.", - "NCTID": "NCT01859130" - }, - { - "brief_title": "Study of Apremilast to Evaluate the Safety and Effectiveness for Patients With Rheumatoid Arthritis", - "phase": "Phase 2", - "drugs": "['Apremilast 30 mg', 'Apremilast 20 mg', 'Placebo']", - "drugs_list": [ - "Apremilast 30 mg", - "Apremilast 20 mg", - "Placebo" - ], - "diseases": "['Rheumatoid Arthritis']", - "diseases_list": [ - "Rheumatoid Arthritis" - ], - "enrollment": "237.0", - "inclusion_criteria": "inclusion criteria: \n\n Must have a documented diagnosis of Rheumatoid Arthritis (1987 American College of Rheumatology Criteria) with onset of signs/symptoms of disease \u2265 4 months of duration from randomization. \n\n Must be receiving treatment on an outpatient basis. \n\n Must have active disease despite current methotrexate treatment as defined below: \n\n \u2265 6 swollen joints (66 swollen joint count) AND \n\n \u2265 6 tender joints (68 tender joint count) \n\n -. Must meet at least one of the four lab requirements below: \n\n High Sensitivity C-Reactive Protein (hsCRP) \u2265 10 mg/L \n\n Erythrocyte Sedimentation Rate (ESR) > 28 mm after the first 1 hour \n\n Positive for Rheumatoid Factor (RF) \n\n Positive for Anti-cyclic Citrullinated Peptide (anti-CCP) antibodies \n\n For participants participating in the Magnetic Resonance Imaging (MRI) assessment: \n\n \u2022 Must have Rheumatoid Arthritis joint involvement, as assessed by swollen joint counts in: 1) at least two Metacarpophalangeal (MCP) swollen joints on the same hand, or 2) at least one swollen Metacarpophalangeal (MCP) joint and swollen wrist on the same hand. \n\n Must have been treated with methotrexate for at least 4 months prior to randomization, and must be on stable dose. Participants will be required to maintain their stable dose through Week 52 of the study. Oral folate (folic acid) supplementation is required with a minimum dose of 5 mg/week, or instead leucovorin may be used up to 10 mg/week orally. \n\n \u2022 Non-steroidal anti-inflammatory drugs (NSAIDs) and pain medications are allowed, however, must be on stable regimen for at least 7 days prior to randomization and through Week 52 of the study. \n\n Oral corticosteroids (if taken) are allowed, however, must be on stable dose of prednisone \u2264 10 mg/day or equivalent for at least 28 days prior to randomization and through Week 52 of the study. \n\n Must meet the following laboratory criteria at screening: \n\n White blood cell count \u2265 3000/mm^3 (\u2265 3.0 x 10^9/L) and < 14,000/mm^3 (< 14 x 10^9/L) \n\n Platelet count (\u2265 100,000/\u03bcL ((\u2265 100 x 10^9/L) \n\n Serum creatinine \u2264 1.5 mg/dL (\u2264 132.6 \u03bcmol/L) \n\n Aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase or serum glutamic-pyruvic transaminase (ALT/ SGPT) \u2264 2 x upper limit of normal (ULN). If initial test shows Aspartate aminotransferase (AST) or alanine aminotransferase (SLT) or 2 times the upper limit of normal (ULN), one repeat test is allowed during the screening period. \n\n Total bilirubin \u2264 2 mg/dL (\u2264 34 \u03bcmol/L). If initial test result is > 2 mg/dL, one repeat test is allowed during the screening period. \n\n Hemoglobin \u2265 9 g/dL (\u2265 5.6 mmol/L) \n\n Hemoglobin A1c \u2264 9.0% \n\n Negative for hepatitis B surface antigen \n\n Negative for hepatitis C antibody \n\n Males who engage in activity in which conception is possible must use protocol described barrier contraception while on Investigational Product and for at least 28 days after the last dose of Investigational Product. \n\n Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use protocol described contraception while on Investigational Product and for at least 28 days after taking the last dose or Investigational Product. \n\n ", - "exclusion_criteria": ": \n\n Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization. \n\n Rheumatic autoimmune disease other than Rheumatoid Arthritis, including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis or significant systemic involvement secondary to Rheumatoid Arthritis (eg, vasculitis, pulmonary fibrosis or Felty syndrome). Sj\u00f6gren syndrome secondary to Rheumatoid Arthritis is allowable. \n\n Functional Class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis. \n\n Prior history of, or current, inflammatory joint disease other than Rheumatoid Arthritis (eg, gout, reactive arthritis, psoriatic arthritis, ankylosing spondylitis, Lyme disease). \n\n Receiving treatment with Disease-modifying antirheumatic drugs (DMARDs) (other than methotrexate), including biologic Disease-modifying antirheumatic drugs (DMARDs)Previous use is only allowed after adequate washout prior to randomization. \n\n Inadequate response to treatment with an anti-tumor necrosis factor (anti-TNF) agent. Patients who terminated previous anti-tumor necrosis factor (anti-TNF) treatment due to cost or safety reason, such as discomfort with the subcutaneous injections, may participate in this study after adequate washout. \n\n Treatment with any investigational agent within four weeks (or five half-lives of the investigational drug, whichever is longer) of screening. \n\n Previous treatment with any cell depleting therapies, including investigational agents. \n\n Treatment with intravenous gamma globulin, plasmapheresis or Prosorba\u00ae column within 6 months of baseline. \n\n Intra-articular or parenteral corticosteroids are not allowed within 6 weeks prior to randomization. \n\n Any previous treatment with alkylating agents such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation. \n\n Pregnant women or nursing (breast feeding) mothers. \n\n Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including severe or very severe chronic obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus as defined by Hemoglobin A1c > 9.0%) or gastrointestinal (GI) disease. \n\n Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids. \n\n Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, Hepatitis B and C, and herpes zoster, but excluding onychomycosis) or any major episode of infection requiring hospitalization or treatment with IV or oral antibiotics within 4 weeks of screening. \n\n History of positive Human Immunodeficiency Virus (HIV), or congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease). \n\n History of malignancy, including solid tumors and hematologic malignancies (except basal cell carcinoma of the skin that has been excised and cured). \n\n History of alcohol, drug or chemical abuse within the 6 months prior to screening. \n\n Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. \n\n Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. \n\n Any condition that in the investigator's opinion would interfere significantly with the efficacy evaluations, including the pain and joint assessments (eg, fibromyalgia). \n\n For Magnetic Resonance Imaging (MRI) Only: \n\n Receiving medication(s) or will require medication(s) during the study that impact on vascular flow (eg, nitrates, calcium channel blockers, ergot containing drugs) on the day of the Magnetic Resonance Imaging (MRI test and in the investigator's judgement the subject cannot hold back from taking these medications on the day of the Magnetic Resonance Imaging (MRI) prior to the Magnetic Resonance Imaging (MRI) test. The subject can continue taking the medication(s) at any time after the Magnetic Resonance Imaging (MRI) test is completed, as clinically indicated and scheduled. Exclusions of antihypertensive and migraine medications can be determined after discussion with the Sponsor. \n\n Unable to undergo an Magnetic Resonance Imaging (MRI) examination, including but not limited to the presence of a pacemaker, defibrillator, or other implanted device such as anterior interbody cages, aneurysm clip, pedicle screws, or any other metal contained in the body (eg, such as tattoos that contain metallic pigment, or metal in the eyes from metal grinding [eg, a metal worker, etc]), or severe claustrophobia, or any other contraindication to an Magnetic Resonance Imaging (MRI) as per local imaging center guidelines. \n\n Allergic or adverse reactions to gadolinium \n\n Estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73m2 (based on the Modification of Diet in Renal Disease [MDRD] formula).", - "brief_summary": "The purpose of this study is to determine whether Apremilast is safe and effective in the treatment of patients with rheumatoid arthritis, specifically in improving signs and symptoms of rheumatoid arthritis (tender and swollen joints, pain, physical function and structure) in treated patients who have had an inadequate response to Methotrexate.", - "NCTID": "NCT01285310" - }, - { - "brief_title": "Infliximab Therapy in Patients With Refractory Polymyalgia Rheumatica", - "phase": "Phase 3", - "drugs": "['infliximab', 'inactive powder']", - "drugs_list": [ - "infliximab", - "inactive powder" - ], - "diseases": "['Polymyalgia Rheumatica']", - "diseases_list": [ - "Polymyalgia Rheumatica" - ], - "enrollment": "23.0", - "inclusion_criteria": "inclusion criteria: \n\n PMR patients that after 2 years of corticosteroid treatment are not able to reduce the dose of prednisone below 5 mg/day or equivalent. \n\n PMR patients that after 6 months of corticosteroid treatment are not able to reduce the dose of prednisone below 7,5 mg/day or equivalent. \n\n PMR patients should fulfill the criteria proposed by Chuang et al (8): \n\n Age \u2265 of 50 years. \n\n Development of bilateral moderately/severe aching and stiffness persisting for 1 month or more, involving two of the following areas: neck or torso, shoulders or proximal regions of the arms, and hips or proximal aspects of the thighs. \n\n ESR \u2265 40 mm/h. \n\n Complete clinical response to low-dose of steroids (prednisone or equivalent \u2264 20mg/day) \n\n ", - "exclusion_criteria": ": \n\n -Patients with biopsy-proven GCA or those with cranial symptoms or signs suggestive of GCA but without biopsy-proven arteritis. \n\n Patients with clinical features suggestive of RA or other connective tissue disorders. \n\n Chronic infections such as HIV, hepatitis B or C, active mycobacterial or fungal infections, etc. \n\n Neoplasm or a history of malignancy in the preceding 5 years. \n\n Patients with multiple sclerosis or other demilinizating disorders. \n\n Patients with cytopenias: leukopenia (leukocytes \u2264 3.5x109/L.), thrombocytopenia (platelets \u2264 100x109/L.) and/or anemia (\u2264 10 g./dl.) \n\n Patients with cardiac failure (functional class III / IV). \n\n Any other condition that contraindicates Infliximab therapy", - "brief_summary": "Rheumatic Polymyalgia(PMR) is a relatively common chronic inflammatory disorder of unknown origin which predominantly develops in elderly subjects and presents with severe pain and stiffness in the neck, shoulder and pelvic girdles, along with increased acute phase reactants. Systemic manifestations such as fever, anorexia and weight loss are characteristic signatures of PMR.~Corticosteroids (CS) constitute the standard treatment of PMR. Although in most patients the symptoms of the disease disappear after one or two years of treatment, a proportion of patients remain CS-dependent with the subsequent CS toxicity. Open label studies have suggested that tumour necrosis factor (TNF) antagonists lead to sustained improvement and CS sparing effect in patients with refractory PMR.~The investigators conducted a randomised, double-blind, placebo controlled trial with infliximab in CS-dependent patients with PMR. Patients with CS-dependent PMR (defined as requiring \u2265 5 mg/day after at least 2 years of treatment to maintain remission or \u2265 7.5 mg/day after at least 6 months) were randomly assigned to receive Infliximab (5 mg/kg i.v) at 0, 2, 6, 14 and 22 weeks (n = 12) or placebo (n = 11) together with CS that were reduced according to a predefined schedule. The primary outcome was the proportion of responder patients -defined as individuals with both complete clinical and analytical remission without receiving CS for at least three months- at 24 weeks. Secondary outcomes were cumulative CS doses and adverse events proportion.", - "NCTID": "NCT01423591" - }, - { - "brief_title": "High-Field MRI Characterization of Wrist and Hand Cartilage Abnormalities in Inflammatory and Chronic Rheumatisms", - "phase": "", - "drugs": "['high-field MRI (3 Teslas)', 'high-field MRI (3 Teslas)', 'high-field MRI (3 Teslas)', 'high-field MRI (3 Teslas)']", - "drugs_list": [ - "high-field MRI (3 Teslas)", - "high-field MRI (3 Teslas)", - "high-field MRI (3 Teslas)", - "high-field MRI (3 Teslas)" - ], - "diseases": "['Abnormality', 'Inflammation', 'Rheumatism']", - "diseases_list": [ - "Abnormality", - "Inflammation", - "Rheumatism" - ], - "enrollment": "34.0", - "inclusion_criteria": "inclusion criteria: \n\n gp Suspects or affected by rheumatoid polyarthritis \n\n Morning articular Stiffness of at least 15 minutes. \n\n Arthalgias or Arthritises of at least three joints(articulations), among which those of the hand. \n\n Possible rheumatoid Presence of a factor(mailman) and\\or Antibody anti peptides positive citrullin\u00e9s. \n\n Typical possible radiological Hurts on the standard clich\u00e9s(pictures) of the reached(affected) joints(articulations). \n\n gp Affected by stiffening spondylitis with axial and peripheral infringement : \n\n . Lumbago and steepness lumbar vertebra inflammatory. 2. Arthralgias and\\or peripheral arthritises 3. Possible presence of an all\u00e8le HLA 4. Possible presence of a sacro-illite 5. Absence of the other rheumatic markers \n\n gp Affected by connectivity with anti-nuclear antibody positive and / or specific antibodies, suffering of polyarthralgias with or without arthritis \n\n gp Healthy control \n\n gp Presenting a degenerative osteoarthritis of the wrist traumatic comment, noticed radiologically, which will serve as not inflammatory control. \n\n ", - "exclusion_criteria": ": \n\n Claustrophobia, \n\n metallic foreign bodies, \n\n pacemakers The pregnant women, \n\n parturients or who breast-feed are excluded from the study", - "brief_summary": "The present project aims at evaluating the diagnostic potential of high-field MRI (3 Teslas) for joint disease. At this field, given that isotropic image resolution of 400 microns can be obtained, one could expect an early detection of joint abnormalities. The additional aim of this project will be to develop a quantitative analyse of the corresponding high-resolution images.", - "NCTID": "NCT01058161" - }, - { - "brief_title": "Efficacy Study Of Tofacitinib In Pediatric JIA Population", - "phase": "Phase 3", - "drugs": "['CP-690,550 (tofacitinib)', 'placebo']", - "drugs_list": [ - "CP-690,550 (tofacitinib)", - "placebo" - ], - "diseases": "['Juvenile Idiopathic Arthritis']", - "diseases_list": [ - "Juvenile Idiopathic Arthritis" - ], - "enrollment": "225.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female aged 2 to <18 years. \n\n Must meet International League Against Rheumatism (ILAR) JIA diagnostic criteria for one of the following categories with active disease for at least 6 weeks: \n\n Extended oligoarthritis; \n\n Polyarthritis (RF+); \n\n Polyarthritis (RF-); \n\n Systemic JIA with active arthritis but without active systemic features in the prior 6 months and at the time of enrollment; \n\n Psoriatic arthritis; \n\n Enthesitis related arthritis. Subjects with polyarticular course JIA (ie, extended oligoarthritis, polyarthritis RF+, polyarthritis RF , systemic JIA with active arthritis but without active systemic features) must have a minimum of 5 active joints (an active joint is defined as a joint with swelling or, in the absence of swelling, limited range of motion accompanied by either pain on motion or tenderness) at screening and baseline to be eligible for study entry. \n\n Subjects with psoriatic or enthesitis related arthritis must have a minimum of 3 active joints (an active joint is defined as a joint with swelling or, in the absence of swelling, limited range of motion accompanied by either pain on motion or tenderness) at screening and baseline to be eligible for study entry. \n\n Treatment with stable doses of a Non Steroidal Anti inflammatory Drug (NSAID) and/or a stable dose of an oral glucocorticoid, and/or a stable dose of methotrexate is permitted. \n\n For subjects receiving an oral glucocorticoid: Glucocorticoids may be administered at a maximum dose of 0.2 mg of prednisone equivalent per kilogram per day or 10 mg per day for \u2265 2 weeks before baseline, whichever is lower. \n\n For subjects receiving methotrexate (MTX) treatment: MTX may be administered either orally or parenterally at doses not to exceed 25 mg/wk or 20 mg/m2/week (whichever is lower); participants must have taken MTX for 3 months and be at a stable dose for at least 6 weeks before baseline. Subjects taking MTX must be taking folic acid or folinic acid in accordance with local standards. \n\n For subjects with psoriatic arthritis, the following topical treatments for psoriasis are allowed: non medicated emollients for use over the whole body; topical steroids including hydrocortisone and hydrocortisone acetate \u22641% for the palms, soles, face, and intertriginous areas only; tar, salicylic acid preparations, and shampoos free of corticosteroids are permitted only for the scalp \n\n Inadequate response or intolerance to at least one Disease Modifying Anti Rheumatic Drug (DMARD), which may include MTX or biologic agents; in the case of ERA and psoriatic arthritis, inadequate response to Non Steroidal Anti Inflammatory Drugs (NSAIDs). \n\n No evidence or history of untreated or inadequately treated active or latent tuberculosis (TB) infection as evidenced by the following: \n\n A negative QuantiFERON \u00aeTB Gold In Tube test performed within the 3 months prior to screening. A negative purified protein derivative (PPD) test can be substituted for the QuantiFERON\u00ae TB Gold In Tube test only if the central laboratory is unable to perform the test or cannot determine the results to be positive or negative and the Pfizer medical monitor is informed and agrees on a case by case basis. \n\n Chest radiograph without changes suggestive of active tuberculosis (TB) infection within 3 months prior to screening is recommended and should be performed according to local standards of care or country-specific guidelines. \n\n No history of either untreated or inadequately treated latent or active TB infection. \n\n If a subject has previously received an adequate course of therapy for either latent (9 months of isoniazid in a locale where rates of primary multi drug resistant TB infection are <5% or an acceptable alternative regimen) or active (acceptable multi drug regimen) TB infection, neither a PPD test nor a QuantiFERON-Gold\u00aeTM test need be obtained. A chest radiograph should be obtained if not done within the 3 months prior to screening. To be considered eligible for the study, the chest radiograph must be negative for active tuberculosis infection. \n\n A subject who is currently being treated for latent TB infection can only be enrolled with confirmation of current incidence rates of multi-drug resistant TB infection, documentation of an adequate treatment regimen, and prior approval of the Sponsor. \n\n Fertile males and females who are, in the opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) must be willing and able to use a highly effective method of contraception as outlined in this protocol during the study and for at least 28 days after the last dose of study medication. \n\n 6 Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. \n\n 7. Evidence of a personally signed and dated Informed Consent document and Assent document (as appropriate) indicating that the subject and a legally acceptable representative/parent(s)/legal guardian has been informed of all pertinent aspects of the study. \n\n ", - "exclusion_criteria": " \n\n Subjects with any of the following characteristics/conditions will not be included in the study: \n\n Previous JIA treatment with tofacitinib. \n\n Systemic JIA (sJIA) with active systemic features (including subjects with characteristic sJIA fever and rash or serositis within 6 months of enrollment). \n\n Persistent oligoarthritis. \n\n Undifferentiated JIA. \n\n Infections: \n\n Chronic infections; \n\n Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 6 months prior to the first dose of study drug; \n\n Any treated infections within 2 weeks of Baseline visit; \n\n A subject know to be infected with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C; \n\n History of infected joint prosthesis with prosthesis still in situ. \n\n History of recurrent (more than one episode) herpes zoster or disseminated (at least one episode) herpes zoster, or disseminated (at least one episode) herpes simplex. \n\n Active uveitis (according to SUN criteria) within 3 months of enrollment. \n\n Blood dyscrasias, including: \n\n Hemoglobin <10 g/dL or Hematocrit <33%; \n\n White Blood Cell count <3.0 x 109/L; \n\n Neutrophil count <1.2 x 109/L; \n\n Platelet count <100 x 109/L; \n\n Lymphocyte count <0.75 x 109/L. \n\n Estimated glomerular filtration rate [GFR] <40 mL/min/1.73 m2 at Screening. GFR will be calculated by the central lab using the bedside Schwartz formula. \n\n Current or recent history of uncontrolled clinically significant renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease. \n\n Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \u22651.5 times the upper limit of normal. \n\n History of any other rheumatologic disease, other than Sjogren's syndrome.. \n\n History or current symptoms suggestive of lymphoproliferative disorders (eg, Epstein Barr Virus [EBV] related lymphoproliferative disorder, lymphoma, leukemia, or signs and symptoms of current lymphatic disease). \n\n Vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the first dose of study drug, or is expected to be vaccinated or to have household exposure to these vaccines during treatment or during the 6 weeks following discontinuation of study drug. \n\n Subjects without documented evidence of having received at least one dose of the varicella vaccine in countries where the vaccine is approved and standard of care or those who do not have evidence of prior exposure to varicella zoster virus (VZV) based on serological testing (ie, VZV IgG Ab). \n\n Current malignancy or history of any malignancy with the exception of adequate treated or excised basal cell or squamous cell or cervical cancer in situ. \n\n Subjects who have previously failed more than 3 biologic therapies (with different mechanisms of action) for JIA. \n\n Subjects with a first degree relative with a hereditary immunodeficiency; IgA deficiency not exclusionary. \n\n Recent (within 28 days prior to first dose of study drug) significant trauma or major surgery. \n\n Subjects receiving potent and moderate CYP3A4 inhibitors or inducers. \n\n Prior treatment with non B cell specific lymphocyte depleting agents/therapies (eg, almetuzumab [CAMPATH], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc.). Subjects who have received rituximab or other selective B lymphocyte depleting agents (including experimental agents) are eligible if they have not received such therapy for at least 1 year prior to study baseline and have normal CD 19/20+ counts by FACS analysis. \n\n Use of prohibited prescription or non prescription drugs and dietary supplements listed in Appendix 1 and Appendix 4 within the specified time frame prior to the first dose of study medication. \n\n Herbal supplements must be discontinued at least 28 days prior to the first dose of study medication. \n\n Use of certain biologic and non biologic DMARDs are disallowed at any time during this study (Appendix 1). \n\n For subjects with PsA, oral and topical medications and alternative treatments that could affect psoriasis are prohibited (see Inclusion Criterion 2 for exceptions). This includes topical corticosteroids, tars, keratolytics, anthralin, vitamin D analogs, and retinoids which must be discontinued at least 2 weeks prior to first dose of study drug. Also prohibited is ultraviolet B (UVB) (narrowband or broadband) phototherapy that must be discontinued at least 2 weeks prior to first dose of study drug. Psoralens + ultraviolet A (UVA) phototherapy (PUVA) must be discontinued at least 4 weeks prior to first dose of study drug. \n\n Subjects who are children of or related to investigational site staff members, site staff members otherwise supervised by the investigator, or Pfizer employees directly involved in the conduct of the study. \n\n Participation in other studies involving investigational drug(s) within 4 weeks or 5 half lives (whichever is longer) prior to study entry and/or during study participation. Exposure to investigational biologics should be discussed with the Sponsor. \n\n Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. \n\n Pregnant or nursing females are excluded.", - "brief_summary": "Evaluate efficacy, safety and tolerability of tofacitinib in pediatric JIA patients.", - "NCTID": "NCT02592434" - }, - { - "brief_title": "Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Rheumatoid Arthritis', 'Ankylosing Spondylitis', 'Psoriatic Arthritis']", - "diseases_list": [ - "Rheumatoid Arthritis", - "Ankylosing Spondylitis", - "Psoriatic Arthritis" - ], - "enrollment": "155.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients aged \u2265 18 years for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis \n\n Patients must fulfill international and national guidelines for the use of a biological disease modifying antirheumatic drug in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (chest x-ray and interferon gamma release assay or purified protein derivative-skin test negative for tuberculosis). In addition one of the following criteria must be fulfilled: \n\n unsatisfactory disease modifying antirheumatic drug response defined as failure to treatment with at least two disease modifying antirheumatic drugs including Methotrexate in patients with rheumatoid arthritis or psoriatic arthritis \n\n unsatisfactory non steroidal antiinflammatory drug response in patients with ankylosing spondylitis or unsatisfactory response to prior biological disease modifying antirheumatic drugs in patients with rheumatoid arthritis or psoriatic arthritis or ankylosing spondylitis \n\n ", - "exclusion_criteria": ": \n\n Patients who meet contraindications as outlined in the latest version of the Humira syringe\u00ae summary of product characteristics and Humira Pen\u00ae summary of product characteristics \n\n Patients participating in another study program or clinical trial \n\n Patients who have been treated with Humira before", - "brief_summary": "The purpose of this study is to assess whether or not adalimumab (Humira\u00ae) can influence pain medication in participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) with or without comorbidities, which do not constitute a contraindication for adalimumab as stated in the released summary of product characteristics. Therefore it shall be evaluated if pain medication which is used in these participants is changed, reduced or stopped due to adalimumab treatment.", - "NCTID": "NCT01273519" - }, - { - "brief_title": "Close Kinetic Chain Exercise With Kinesio Taping in the Management of Patellofemoral Pain Syndrome", - "phase": "", - "drugs": "['Acetaminophen 500mg', 'Kinesio taping']", - "drugs_list": [ - "Acetaminophen 500mg", - "Kinesio taping" - ], - "diseases": "['Patellofemoral Pain Syndrome']", - "diseases_list": [ - "Patellofemoral Pain Syndrome" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria: \n\n Age between fifteen and thirty-five years, \n\n Presenting unilateral PFPS with six months of evolution, \n\n Presenting anterior or retro knee pain that presents itself when undergoing two or more of the following activities: \n\n (squatting, running,kneeling, jumping,climbing stairs,physically active patients, with at least thirty minutes of physical activity at least three times per week.) \n\n ", - "exclusion_criteria": ": \n\n Patients with previous knee surgeries, \n\n Chronic pain with more than one year of evolution, \n\n Pregnancy or suspected pregnancy \n\n Application of intra-articular steroids in the three months prior to their evaluation \n\n Patients with meniscal injuries \n\n Ligament or intra-articular knee structures \n\n Degenerative diseases such as diabetes \n\n Rheumatoid arthritis \n\n Osteoarthritis of the knee, hip or ankle \n\n History of dislocation or subluxation of patella \n\n Osgood Schlatter syndrome \n\n Patellar tendinitis or quadriceps.", - "brief_summary": "The investigators will include patients attending outpatient clinic in the area of Orthopedics and Traumatology of our hospital with a diagnosis of unilateral Patellofemoral Pain Syndrome.~Two groups would be made, the control group will receive treatment with acetaminophen and physical therapy rehabilitation, closed chain exercises and stretches at home intended for the strengthening of quadriceps, abductors and internal rotators of the hip for the duration of six weeks. The experimental treatment group will receive the above plus the application of the technique NUCAP Medical Upper Knee Spider \u00ae Kinesio taping on the affected knee. Both groups will be evaluated by an external consultation. They will be assessed by the Tegner Activity Scale, the Kujala score of the WOMAC and visual analog scale (VAS) for pain assessment; these scales will be applied at the beginning, third and sixth week", - "NCTID": "NCT02241148" - }, - { - "brief_title": "Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young Adults", - "phase": "Phase 2", - "drugs": "['Rilonacept']", - "drugs_list": [ - "Rilonacept" - ], - "diseases": "['Juvenile Idiopathic Arthritis']", - "diseases_list": [ - "Juvenile Idiopathic Arthritis" - ], - "enrollment": "71.0", - "inclusion_criteria": "inclusion criteria: \n\n Fulfills International League Against Rheumatism (ILAR) criteria for SJIA \n\n Duration of SJIA lasting at least 6 weeks since onset \n\n Active disease as defined by at least two joints with active disease \n\n Not currently receiving methotrexate OR if taking methotrexate, the dose has remained stable or has been discontinued for 4 weeks prior to screening \n\n Has never received certain biologics OR if previously received biologics, discontinued etanercept for at least 4 weeks prior to screening and discontinued infliximab or adalimumab for at least 8 weeks prior to screening \n\n Not currently receiving corticosteroids OR if taking oral corticosteroids, the dose has remained stable between 2 and 60 mg/day for at least 2 weeks prior to screening \n\n ", - "exclusion_criteria": ": \n\n Past treatment with anakinra, rilonacept, or other biologic IL-1 inhibitor \n\n Treatment with other disease-modifying antirheumatic drugs (DMARDs) including, but not limited to, azathioprine, sulfasalazine, cyclosporine, and thalidomide within 4 weeks of screening \n\n Treatment with leflunomide without cholestyramine washout at the end of therapy \n\n Treatment with cyclophosphamide within 3 months of study entry \n\n Treatment with tacrolimus or tocilizumab within 4 weeks of study entry \n\n Treatment with rituximab within 6 months of study entry \n\n Treatment with intravenous immunoglobulin (IVIG) within 4 weeks of screening \n\n Kidney disease \n\n AST or ALT levels more than two times the upper limit of normal \n\n Bilirubin levels higher than 1.5 mg/dl \n\n Thrombocytopenia, leukopenia, or neutropenia \n\n Abnormal prothrombin time (PT) and partial thromboplastin time (PTT) tests \n\n Low levels of plasma fibrinogen \n\n Evidence of chronic recurrent infection or other significant, non-SJIA illness that might interfere with study participation \n\n Psychological or cognitive difficulties that might interfere with study participation \n\n Current drug or alcohol abuse \n\n Anticipated poor compliance to assigned study regimen \n\n Participation in another clinical trial within 30 days of study entry \n\n Major surgical procedure within 3 months of study entry", - "brief_summary": "Systemic juvenile idiopathic arthritis (SJIA) is a type of arthritis that typically occurs before 16 years of age. SJIA usually involves heat, pain, swelling, and stiffness in the body's joints. It can also involve fever, rash, anemia, and inflammation in various parts of the body. Rilonacept is a drug that can reduce inflammation. The purpose of this study is to determine whether a rilonacept drug regimen initiated early is more effective than a similar rilonacept drug regimen initiated 4 weeks later when treating children and young adults with SJIA.", - "NCTID": "NCT00534495" - }, - { - "brief_title": "A Controlled Study to Evaluate the Safety and Immunogenicity of StreptAnova\u2122 in Healthy Adults", - "phase": "Phase 1", - "drugs": "['StreptAnova\u2122 (Group A streptococcal (GAS) vaccine)', 'Hepatitis B vaccine', 'Hepatitis A vaccine', 'Human Papillomavirus vaccine']", - "drugs_list": [ - "StreptAnova\u2122 (Group A streptococcal (GAS) vaccine)", - "Hepatitis B vaccine", - "Hepatitis A vaccine", - "Human Papillomavirus vaccine" - ], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "39.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female healthy adults ages 18 to 50 years inclusive; \n\n Good general health as determined by screening evaluation no greater than 42 days before the first immunization; \n\n For women of childbearing age, use of adequate birth control from enrollment until 180 days after the last injection; \n\n Written informed consent, after reading the consent form and having adequate opportunity to discuss the study with an investigator or a qualified designee. \n\n ", - "exclusion_criteria": ": \n\n Presence of any febrile illness or any known or suspected acute illness on the day of any first immunization; \n\n Any chronic illness, whether or not active treatment is required; \n\n Any immunodeficiency (congenital or acquired); \n\n Any history of cardiac pathology (acquired or severe/persistent congenital); \n\n Any history of congenital malformation syndromes associated with congenital heart disease (syndrome complexes, e.g. VATER association; chromosomal disorders, e.g. Down's Syndrome; teratogenic agents, e.g. fetal alcohol syndrome; others, e.g. Noonan's); \n\n Any history of clinical manifestations of auto-immune or systemic diseases (inflammatory disorders, e.g. JRA, SLE, Kawasaki disease; inborn errors of metabolism, e.g. Fabry; connective tissue disorders, e.g. Marfan syndrome; neuromuscular disorders, e.g. Friedreich ataxia; endocrine-metabolic disorders, e.g. hypothyroidism; hematologic disorders, e.g. sickle cell anemia); \n\n Any history of acute rheumatic fever (ARF), post-streptococcal glomerulonephritis (PSGN), undiagnosed acute self-limiting polyarthritis (swelling, heat, redness or tenderness or pain and limitation of motion in >2 joints), or chorea (purposeless, involuntary rapid movements of the trunk and/or extremities); \n\n Any previous echocardiogram suggestive of cardiac pathology; \n\n Any immediate family history (parents, siblings) of ARF, PSGN, self-limiting polyarthritis, chorea, or a collagen-vascular disease such as Lupus or Sj\u00f6gren's syndrome; \n\n Receipt of systemic glucocorticoids (a dose \u2265 20 mg/day prednisone or equivalent) within one month, or any other cytotoxic or immunosuppressive drug within six months; \n\n Receipt of any investigational drug within six months, or prior participation in a clinical trial of a group A streptococcal vaccine; \n\n Receipt of blood products or immunoglobulin (IVIg or IMIg) within three (3) months of study entry/baseline serologic evaluation; \n\n Any physical findings suggestive of acute or chronic illness; \n\n History of receiving Adriamycin or other chemotherapy; \n\n Use of any of the following diet pills: fenfluramine, phentermine, or dexfenfluramins (also known as Pondimin, Redux, Adipex, or Fastin); \n\n History of sensitivity to any component of study vaccines; \n\n Evidence of tissue cross-reactive antibodies to human heart, joint cartilage, kidney, cerebral cortex or basal ganglia by indirect fluorescent antibody assay at pre-vaccination screening; \n\n Repeatable clinical laboratory abnormalities (blood or urine), as defined by lab normal ranges. To exclude transient abnormalities, the investigator may repeat a test up to twice, and if the repeat test is normal, subject may be enrolled; \n\n Echocardiographic finding of valvular dysfunction (stenosis, leaflet thickening or nodules, restricted leaflet mobility, or prolapse), LV dysfunction, atrial or ventricular enlargement, mild or greater mitral regurgitation or aortic insufficiency, moderate or greater tricuspid regurgitation or pulmonic insufficiency, pericardial effusion, or other cardiac pathology as identified by echocardiologist*; \n\n Receipt of any vaccines within 2 weeks of Dose 1; \n\n Clinically significant abnormality on screening electrocardiogram* \n\n Pregnancy or breastfeeding.", - "brief_summary": "This is a single-centered trial of a group A streptococcal (GAS) vaccine, StreptAnova\u2122. The study is designed to assess safety and immunogenicity of three doses (0, 1, 6 months) of one dosage (600 \u00b5g protein) in healthy adults 18 through 50 years of age.", - "NCTID": "NCT02564237" - }, - { - "brief_title": "A Study to Assess the Effect of Tocilizumab + Methotrexate on Prevention of Structural Joint Damage in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)", - "phase": "Phase 3", - "drugs": "['tocilizumab [RoActemra/Actemra]', 'Placebo', 'Methotrexate']", - "drugs_list": [ - "tocilizumab [RoActemra/Actemra]", - "Placebo", - "Methotrexate" - ], - "diseases": "['Rheumatoid Arthritis']", - "diseases_list": [ - "Rheumatoid Arthritis" - ], - "enrollment": "1196.0", - "inclusion_criteria": "inclusion criteria: \n\n adult patients at least 18 years of age with moderate to severe active RA for at least 6 months; \n\n inadequate response to a stable dose of MTX; \n\n patients of reproductive potential must be using reliable methods of contraception. \n\n ", - "exclusion_criteria": ": \n\n major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study; \n\n prior treatment failure with an anti-tumor necrosis factor agent; \n\n women who are pregnant or breast-feeding.", - "brief_summary": "This 3 arm study will compare the safety and efficacy, with respect to a reduction in signs and symptoms and prevention of joint damage, of tocilizumab versus placebo, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients will be randomized to receive tocilizumab 4 mg/kg IV, tocilizumab 8 mg/kg IV or placebo IV, every 4 weeks. All patients will also receive methotrexate, 10-25 mg/week. The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals. After completion of the 2 year study participants could participate in the optional 3 year open label extension phase (year 3 to 5).", - "NCTID": "NCT00106535" - }, - { - "brief_title": "Interleukin-1 Receptor Antagonist (IL-1RA) (ANAKINRA) IN SEVERE SYSTEMIC-ONSET JUVENILE IDIOPATHIC ARTHRITIS", - "phase": "Phase 2; Phase 3", - "drugs": "['Anakinra', 'Pneumo23']", - "drugs_list": [ - "Anakinra", - "Pneumo23" - ], - "diseases": "['Systemic-Onset Juvenile Idiopathic Arthritis']", - "diseases_list": [ - "Systemic-Onset Juvenile Idiopathic Arthritis" - ], - "enrollment": "24.0", - "inclusion_criteria": "inclusion criteria: \n\n SO-JIA (Edmonton's revision of Durban's consensus conference criteria) \n\n Age: at least 2 years and less than 20 years at treatment initiation \n\n Disease duration of at least 6 months \n\n Failure of corticosteroid treatment or requirement for corticosteroid treatment at a daily dose equal to or over 0.3 mg/kg (10 mg in patients whose weight is over 34 kg) \n\n Active and severe systemic symptoms and/or arthritis as assessed by an experienced pediatric Rheumatologists, with at least 3 of the following criteria when assessing Giannini's core-set items: 1) physician global assessment of disease activity of at least 20/100; 2) parent/patient assessment of disease effect on overall well-being of at least 20/100; 3) functional disability with a Children Health Assessment Questionnaire (CHAQ, Ref [9]) score equal to or higher than 0.375/3; 4) 2 joints or more with active arthritis 5) 2 joints or more with non-irreversible limited range of motion (irreversible limited range of motion will be defined by radiological evidence of irreversible joint damage and ankylosis) 6) erythrocyte sedimentation rate (ESR) equal to or higher than 20. \n\n In the absence of disease-related fever, either CRP or first hour ESR or both have to be over the upper limit of normal values so that treatment effect on the systemic part of the disease can be objectively evaluated. \n\n Patients with polyarthritis (at least 5 joints with inflammation and/or limitation of motion) will be eligible for this study only if at least 50% of the affected joints do not present radiological evidence of irreversible damage. \n\n Informed consent signed by the parents or the person legally responsible for the patient if the patient is less than 18, and by the patient if old enough \n\n Teenager girls or young women with childbearing potential must use a contraceptive method (including abstinence \n\n tuberculin test performed before Day 1 and must either be negative or positivity must be related to previous immunization and of normal intensity according to the investigator's judgment \n\n ", - "exclusion_criteria": ": \n\n Previous treatment with IL-1Ra \n\n intra-articular injection or change in the doses of non-steroidal anti-inflammatory drugs and corticosteroids in the 4 weeks preceding the initiation of anakinra treatment \n\n Treatment with another immunosuppressive or disease-modifying drugs that could not be stopped before inclusion (for a duration depending on the drug pharmacokinetic properties) \n\n Contra-indication to the use of anakinra including ongoing active infection or allergy to E Coli's derivate or other components of the drug \n\n Previous history of malignancy or heart insufficiency \n\n Patients with asthma require to be previously assessed by a pneumonologist \n\n Obvious need of therapeutic intervention before study completion such as surgery, intra-articular injection, life vaccine administration \n\n Any of the following: leucocyte counts < 3.6 x 10e9/L, polymorphonuclear neutrophil counts < 1.5 x 10e9/L, platelets < 150 000/mm3, serum creatinin > 1.5 the upper limit of normal range for age, serum alanine and aspartate transaminases > 2 times the upper limit of the normal range, serum bilirubin > 2 times the upper limit of the normal range", - "brief_summary": "Main objective: To test the efficacy of anakinra treatment in children or young adults with corticosteroid-resistant or -dependent Systemic-Onset Juvenile Idiopathic Arthritis (SO-JIA)~Design: Double blind, randomized trial testing the efficacy of one month Anakinra treatment versus placebo (2 groups of 12 patients each). All the patients will be treated with anakinra during the following 11 months and the dose of corticosteroids will be gradually tapered (= descriptive part of the trial to assess the tolerance and efficacy over 12 months).~Hypothesis: 70% significant improvement after 1 month in Anakinra-treated patients versus no more than 10% in the placebo group.~Main inclusion criteria : diagnosis of SO-JIA (Durban consensus conference criteria), age: 2 to 20 years at inclusion, active, corticosteroid-resistant or -dependent disease, no previous IL-1ra treatment.", - "NCTID": "NCT00339157" - }, - { - "brief_title": "Protocol For The Quantitation Of Pain In The Diagnosis Of Polymyalgia Rheumatica", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Polymyalgia Rheumatica', 'Rheumatoid Arthritis', 'Rheumatic Disease']", - "diseases_list": [ - "Polymyalgia Rheumatica", - "Rheumatoid Arthritis", - "Rheumatic Disease" - ], - "enrollment": "142.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients signing Informed Consent \n\n ", - "exclusion_criteria": ": \n\n Patients less than 50 years old", - "brief_summary": "The aim of this study is to evaluate a simple and rapid method in order to better define and treat Polymyalgia Rheumatica by measuring levels of muscle achiness and pain with a blood pressure cuff.", - "NCTID": "NCT00847236" - }, - { - "brief_title": "A Short Metaphyseal Fitting Total Hip Arthroplasty in Young and Elderly Patients", - "phase": "Phase 4", - "drugs": "['Total Hip Arthroplasty']", - "drugs_list": [ - "Total Hip Arthroplasty" - ], - "diseases": "['Osteonecrosis', 'Osteoarthritis']", - "diseases_list": [ - "Osteonecrosis", - "Osteoarthritis" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Osteoarthritis of hip joint requiring total hip arthroplasty \n\n ", - "exclusion_criteria": ": \n\n Neurologic disorders affecting motor function of lower extremity foot and ankle disorders limiting ambulation of the patient \n\n Patients with bone metabolic disorders other than osteoporosis which prevents normal bone metabolism \n\n Multi-systemic inflammatory arthritis which debilitates patients other than hip joint.", - "brief_summary": "The investigators determined whether~new short, metaphyseal-fitting cementless anatomical femoral stem provides major functional improvements~radiographically secure implant fixation is achieved with this new stem~the bone content is preserved at the baseline level or above at the final follow-up~these procedures are associated with early failure and complications.", - "NCTID": "NCT01345097" - }, - { - "brief_title": "A Study Assessing the Efficacy and Safety of Lodotra\u00ae Compared to Prednisone IR in Subjects Suffering From PMR", - "phase": "Phase 3", - "drugs": "['Lodotra\u00ae', 'Prednisone IR (immediate release)']", - "drugs_list": [ - "Lodotra\u00ae", - "Prednisone IR (immediate release)" - ], - "diseases": "['Polymyalgia Rheumatica']", - "diseases_list": [ - "Polymyalgia Rheumatica" - ], - "enrollment": "62.0", - "inclusion_criteria": "inclusion criteria: \n\n Males or females, 50 years of age or older who provided written informed consent. \n\n Females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner). \n\n Subjects newly diagnosed with polymyalgia rheumatica and previously untreated with glucocorticoids for PMR. The diagnosis of polymyalgia rheumatica must be confirmed by all of the following criteria: \n\n New onset bilateral shoulder pain or new onset bilateral shoulder and hip girdle pain. \n\n PMR VAS score over the last 24 hours before the Screening Visit \u2265 50 (on a 0 - 100 scale). \n\n Morning stiffness duration of \u2265 45 min on the day before the Screening Visit. \n\n Acute phase response shown by elevated C-reactive protein (CRP; \u2265 2 times ULN). \n\n Subjects willing and able to participate in all aspects of the study and comply with the use of study medication. \n\n ", - "exclusion_criteria": ": \n\n Females who are pregnant (positive \u03b2-hCG test) or lactating. \n\n Subjects with any contraindication/history of hypersensitivity to predniso(lo)ne or other ingredients. \n\n Significant renal impairment (serume creatinine > 150 \u00b5mol/L). \n\n Significant hepatic impairment (ALT, AST and GGT > 2.5 ULN). \n\n Subjects suffering from another disease which requires glucocorticosteroid treatment. Topical glucocorticosteroids, e.g. intra-nasal or inhaled glucocorticosteroids are allowed but should be kept at a stable dose throughout the study. \n\n Continued use of systemic glucocorticoids within 4 weeks prior to the Screening Visit. \n\n Joint injections with glucocorticoids within 6 weeks prior to the Screening Visit. \n\n Subjects who require treatment with non-permitted concomitant therapies. \n\n Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal or psychiatric disease at the time of screening, as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the subject at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results. \n\n Active alcohol or drug abuse. \n\n Subjects suffering from giant cell arteritis, late onset rheumatoid arthritis or other inflammatory rheumatoid diseases. \n\n Subjects suffering from drug-induced myalgia. \n\n Subjects suffering from fibromyalgia \n\n Subjects suffering from systemic lupus erythemathosus. \n\n Subjects suffering from neurological conditions, e.g. Parkinson's disease. \n\n Subjects suffering from active cancer. \n\n Subjects suffering from an active infection. \n\n Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days prior to the Screening Visit.", - "brief_summary": "The study compares the efficacy and safety of modified release prednisone versus immediate release prednisone in patients suffering from polymyalgia rheumatica.", - "NCTID": "NCT01821040" - }, - { - "brief_title": "Draining PLN and Synovial Inflammation in RA Knee Joints Pre and Post Anti-TNF or B Cell Depletion Therapy", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Rheumatoid Arthritis']", - "diseases_list": [ - "Rheumatoid Arthritis" - ], - "enrollment": "7.0", - "inclusion_criteria": "inclusion criteria \n\n Signed, IRB-approved, written informed consent \n\n Subjects can be of either gender but must be more than 18 years old. \n\n Subjects must fulfill the disease activity criteria for RA and a DAS28 will be assessed at baseline and at 2 months after rituximab therapy. \n\n Aim A - Eligible subjects must meet criteria for RA and have an inadequate response to MTX defined as DAS28 >5.1. They must have been on a steady dose of MTX (between 15 and 20 mg /week for a minimum of 8 weeks). Subjects must have evidence of knee synovitis on exam to enter the study. \n\n Aim B - Subjects must have demonstrated a response to a TNF antagonist as evidenced by a DAS score <2.8 or <4 tender and swollen joints. Flare will be defined as a DAS 28 >5.1 of more than 8 swollen and tender joints. Subjects must have evidence of knee synovitis to enter the study. Subjects will be off etanercept, infliximab or adalimumab for 4 weeks before starting BCDT. All subjects must also be on a stable dose of DMARD (MTX, leflunomide, azulfidine, hydroxychloroquine) for 8 weeks before entry into the study. \n\n ", - "exclusion_criteria": " \n\n Patients will be excluded for medical or other reasons at the discretion of the investigators. The reasons for the exclusion must be recorded, e.g. risk of non-compliance, vulnerability, medically unstable, etc. \n\n Active systemic disorders or inflammatory conditions (i.e., chronic infection with hepatitis B, hepatitis C or HIV) other than the conditions being studied. \n\n Patients with a plasma creatinine > 1.5 mg/dl \n\n Aim B - Subjects with an allergy to corticosteroids will be excluded from the study. \n\n Anyone answering yes to the following questions will be excluded: \n\n Do you have a history of: \n\n Cardiac (Heart) pacemaker or defibrillator? \n\n Cardiac (Heart) valve replacement or prosthesis? \n\n Aneurysm clips from brain surgery? \n\n Ear prosthesis (cochlear or stapedial implant)? (hearing aids?) \n\n Neurostimulator? \n\n Biostimulator? \n\n Any type of pumps in or on your body? \n\n Shrapnel, gunshot wound, BB pellet? \n\n Metallic penile prosthesis? \n\n Metallic blood vessel filter or stent? \n\n Orthopedic prosthesis? \n\n Have you ever had an injury involving metal fragments in your eye? \n\n Have you ever had neurosurgery (brain or skull surgery)? \n\n Note: Subjects treated with rituximab will not be excluded from study based on their immunosuppressive drugs but use of these agents will be recorded and discussed in the analysis.", - "brief_summary": "The purpose of this study is to examine the effect of anti-TNF therapy on rheumatoid arthritis using magnetic resonance imaging (MRI) and ultrasound imaging.~Anti-TNF therapies include a group of medications such as Enbrel, Remicade and Humira that affect your body's inflammatory response. These medications are routinely prescribed for the treatment of rheumatoid arthritis.", - "NCTID": "NCT01083563" - }, - { - "brief_title": "Interleukin-1 Trap to Treat Autoinflammatory Diseases", - "phase": "Phase 2", - "drugs": "['IL-1 Trap']", - "drugs_list": [ - "IL-1 Trap" - ], - "diseases": "['Inflammation', 'Familial Mediterranean Fever', \"Still's Disease, Adult-Onset\"]", - "diseases_list": [ - "Inflammation", - "Familial Mediterranean Fever", - "Still's Disease", - "Adult-Onset" - ], - "enrollment": "11.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female subjects with inflammatory disease greater than or equal to 18 years of age. \n\n Participation in NIH study number 94-AR-0105 (Genetics and Pathophysiology of FMF and Related Disorders) \n\n Subjects presenting with active NOMID, MWS, FCAS, FMF, or adult Still's disease based on clinical signs/symptoms and/or biochemical markers such as acute phase reactants (CRP, SAA or ESR). Subjects need not have both clinical features and biochemical markers of disease to be enrolled. However, both clinical and laboratory responses will be evaluated in each subject for improvement as outcome measures (even improvement of laboratory values found to be within the normal range at baseline). \n\n NOMID, MWS, and FCAS: Diagnosis will be based on the history of classical features of disease including fevers, rash, joint involvement, CNS involvement. Approximately half of all subjects with these clinical syndromes are mutation negative; however, in the experience of the principal investigator these subjects show favorable clinical response to IL-1 blockade with anakinra. Therefore, subjects with or without recognized mutations in CIAS1 will be eligible to enroll in this study. Active disease will be defined as either the presence of aforementioned classical features, or a history of such features that became quiescent in the setting of therapy with anakinra. However, before a patient who has quiescent disease and is currently taking anakinra can receive study drug, he/she must fulfill criteria for active disease after anakinra has been discontinued. \n\n FMF will be diagnosed on the basis of documented presence of one or two mutant alleles of MEFV as well as the history of classical clinical features of FMF such as periodic fevers, rash, arthritis, arthralgia, or episodes of serositis. Subjects must be considered non-responsive to colchicine (up to 2 milligrams per day) on the basis of continued symptoms or flares (greater than or equal to one per month) or elevated acute phase reactants (ESR, CRP or SAA greater than or equal to 1.5 times the upper limit of normal between attacks) despite treatment with maximally tolerated doses of colchicine. Positive genetic test will be required for FMF to rule out the possibility that non-response to colchicine is due to misdiagnosis. \n\n Adult Still's disease will be diagnosed on the basis of history of classical clinical features such as fevers, evanescent salmon-pink rash, arthritis, arthralgia, and myalgia. Active disease will be defined as presence of one or more of these features and/ or elevation of acute phase reactants (ESR, CRP or SAA greater than or equal to 1.5 times the upper limit of normal). \n\n Subjects currently treated with anakinra may be enrolled in this study even though autoinflammatory disease may be quiescent. For these subjects a history of active autoinflammatory disease prior to treatment with anakinra will be sufficient. Subjects must be greater than 48 hours from their last dose of anakinra before beginning IL-1 Trap therapy, and will not take anakinra for the remainder of their enrollment in the study. However, before study drug is administered subjects have to manifest signs of active disease as described above \n\n Stable dose of steroids, NSAIDs, DMARDs, or colchicine for four weeks prior to enrollment visit. \n\n Females of childbearing potential (young women who have had at least one menstrual period regardless of age) must have a negative urine pregnancy test at screening and a negative serum pregnancy test at baseline prior to performance of any radiologic procedure or administration of study medication. \n\n Women of childbearing age and men able to father a child, who are sexually active, who agree to use a form of effective birth control, including abstinence. \n\n Negative PPD test using 5 T.U. intradermal testing per CDC guidelines, and no evidence of active TB on chest X-ray. Subjects with latent TB (positive PPD test) currently treated with adequate therapy initiated for at least one month prior to first dose of study medication may be included. Full prophylaxis regimens will be completed. Subjects who have been BCG-vaccinated will also be skin-tested. \n\n Able to understand, and complete study-related questionnaires. \n\n Able and willing to give informed consent and abide with the study procedures. \n\n ", - "exclusion_criteria": ": \n\n Treatment with a live virus vaccine during 3 months prior to baseline visit. No live vaccines will be allowed throughout the course of this study. \n\n Current treatment with TNF inhibitors or recent discontinuation of TNF inhibitors (use within less than 5 half-lives of TNF inhibitor agent). \n\n Presence of active infections or a history of pulmonary TB infection with or without documented adequate therapy. Subjects with current active TB, or recent close exposure to an individual with active TB are excluded from the study. \n\n Chest x-ray read by a radiologist with pleural scarring and/or calcified granuloma consistent with prior TB. \n\n Positive test for or prior history of HIV, Hepatitis B or C. \n\n History or concomitant diagnosis of congestive heart failure. \n\n History of malignancy. Subjects deemed cured of superficial malignancies such as cutaneous basal or squamous cell carcinomas, or in situ cervical cancer may be enrolled. \n\n Known hypersensitivity to CHO cell derived biologicals or any components of IL 1 Trap. \n\n Presence of any additional rheumatic disease or significant systemic disease. For example, major chronic infectious/ inflammatory/ immunologic disease (such as inflammatory bowel disease, psoriatic arthritis, spondyloarthropathy, SLE in addition to autoinflammatory disease). \n\n Presence of any of the following laboratory abnormalities at enrollment visit: creatinine greater than 1.5 times the upper limit of normal, WBC less than 3.6 x 10(9)/mm(3); platelet count less than 150,000 mm(3); ALT or AST greater than 2.0 x ULN (ALT/AST greater than 2.0 x ULN in an adult Still's disease patient would prompt a hepatology consult prior to enrollment unless these abnormalities are considered by the Principal Investigator to be reflective of the underlying Still's disease). \n\n Lactating females or pregnant females. \n\n Subjects with asthma not adequately controlled on current therapy. \n\n Enrollment in any other investigational treatment study or use of an investigational agent, or has not yet completed at least 4 weeks or 5 half-lives, whichever is longer, since ending another investigational device or drug trial. \n\n Subjects for whom there is concern about compliance with the protocol procedures. \n\n Presence of other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the subject's safety, inhibit protocol participation, or interfere with interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.", - "brief_summary": "Autoinflammatory diseases are illnesses characterized by episodes of inflammation that, unlike autoimmune disorders, lack the production of high titer autoantibodies or antigen-specific T cells. There is growing genetic and clinical evidence that Interleukin-1 (IL-1) plays a pathogenic role in several of these diseases. This exploratory study aims to examine the utility of the experimental drug candidate, IL 1 Trap (Regeneron Pharmaceuticals, Inc.) in the treatment of adult subjects with the autoinflammatory disorders Neonatal Onset Multisystem Inflammatory Disease (NOMID), Muckle-Wells Syndrome (MWS), and Familial Cold Autoinflammatory Syndrome (FCAS), Familial Mediterranean Fever (FMF), and adult Still's disease. FMF is associated with mutations in pyrin encoding MEFV. NOMID, MWS and FCAS are associated with mutations in cryopyrin-encoding CIAS1.~This pilot study is designed to address: 1) the utility of IL 1 Trap in the treatment of subjects with diseases known to respond to IL-1 blockade (NOMID/MWS/FCAS) as shown by response to treatment with anakinra [Kineret]; 2) the response to IL-1 blockade of subjects with Adult Still's disease and colchicine-resistant FMF once the efficacy of IL-1 Trap has been established in NOMID/MWS/FCAS subjects; and 3) the biochemistry and genetics of autoinflammatory diseases and IL-1 related inflammation.~IL-1 Trap is a recombinant fusion protein with picomolar affinity for IL-1 and a half-life of approximately 7.5 days in humans. This agent is currently in Phase 2 clinical studies for the treatment of rheumatoid arthritis and initial studies have shown activity against clinical and biochemical indicators of inflammation. Compared with anakinra, this agent may exhibit improved dosing convenience, potential for fewer injection site reactions, and improved efficacy due to the extremely high affinity of IL-1Trap for its target.~In this study, biochemical, genetic, and clinical correlates of autoinflammatory disease will initially be measured at baseline following a withdrawal of any TNF or IL-1 inhibitor medications where applicable. Subjects will receive a course of therapy with IL-1 Trap that is predicted to provide an estimated 3-4 weeks of anti-inflammatory activity. Clinical, biochemical, and genetic correlates of inflammation will be measured at appropriate intervals to ascertain response and to further elucidate disease mechanisms. Subjects will be eligible, based on clinical response, to enter a 1- year extension phase with IL-1 Trap. Those subjects who complete the 1-year extension phase, and maintain improved clinical and laboratory parameters compared to baseline values, may continue to receive study medication at their current dose until the study drug is commercially available.~Investigator comment:~This protocol (from the NIH standpoint) is a continuation of the ongoing protocol 05-AR-0014, with a new change in study sponsor, the NIH replacing Regeneron as sponsor. this protocol therefore still contains background and procedural information that refer to patients with FMF and FCAS and or MWS and Still's disease, however only patients with Still's disease will be newly enrolled from this point on, enrollment for the FCAS and or MWS patients has already been completed and it has been decided to not enroll any more FMF patients because the number of subjects is too low to reach reasonable conclusions, in addition it has been difficult to recruit patients that are eligible. The background section and study procedures have largely been left as in the currently IRB approved protocol.", - "NCTID": "NCT00094900" - }, - { - "brief_title": "Rheumatoid Arthritis Patients on Adalimumab to Evaluate Its Effect on Synovitis Using Ultrasonography in an Egyptian Population", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Rheumatoid Arthritis']", - "diseases_list": [ - "Rheumatoid Arthritis" - ], - "enrollment": "16.0", - "inclusion_criteria": "inclusion criteria: \n\n A patient will be enrolled in this study if he/she fulfills ALL of the following criteria: \n\n Male or Female patients \u2265 18 years of age with diagnosis of RA \n\n Patient is eligible to start adalimumab therapy according to the local product label and prescription guidelines \n\n Patient is na\u00efve to all biologics e.g. anti-cluster of differentiation 4 (anti-CD4) and anti-TNF treatments at the start of the study \n\n Patient has no history of inflammatory arthritis other than rheumatoid arthritis \n\n Patient has no history of lymphoma or leukemia or other malignancies \n\n Has negative result of tuberculosis (TB) screening test or is receiving TB prophylaxis as per local guidelines, Provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations \n\n ", - "exclusion_criteria": ": \n\n Patients that are not diagnosed with rheumatoid arthritis as judged by the American College of Rheumatology criteria \n\n Patient is currently diagnosed with any condition other than rheumatoid arthritis that may affect radiography progression \n\n Susceptibility to infections including TB, as judged by the investigator \n\n Patient is carrier of Hepatitis B virus \n\n Patient is a pregnant or lactating female at the time of screening", - "brief_summary": "This Post-Marketing Observational Study (PMOS) was conducted to assess the effectiveness of adalimumab on reducing synovitis (inflammation of the synovial membrane, which lines movable synovial joints, such as shoulders, elbows, wrists, knees, and hips) in adult participants with Rheumatoid Arthritis (RA) in Egypt. B-mode ultrasonography data was collected from participants receiving adalimumab treatment who had not been treated with any other anti-tumor necrosis factor (anti-TNF) therapy in the past.", - "NCTID": "NCT01782469" - }, - { - "brief_title": "TORPEDO Study: A Study on Rapid Effect of Tocilizumab in Patients With Rheumatoid Arthritis With an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) or Anti-TNF", - "phase": "Phase 3", - "drugs": "['tocilizumab [RoActemra/Actemra]', 'placebo', 'tocilizumab [RoActemra/Actemra]']", - "drugs_list": [ - "tocilizumab [RoActemra/Actemra]", - "placebo", - "tocilizumab [RoActemra/Actemra]" - ], - "diseases": "['Rheumatoid Arthritis']", - "diseases_list": [ - "Rheumatoid Arthritis" - ], - "enrollment": "103.0", - "inclusion_criteria": "inclusion criteria: \n\n adult patients >/= 18 years of age \n\n active moderate or severe rheumatoid arthritis of <10 years duration with inadequate response to methotrexate or anti-TNF \n\n on methotrexate treatment for at least 10 weeks, at least 8 weeks on stable dose \n\n patients receiving oral corticosteroids and/or NSAIDs should be at stable dose for 4 weeks \n\n ", - "exclusion_criteria": ": \n\n rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA \n\n functional class IV by ACR classification \n\n history of inflammatory joint disease other than RA \n\n previous treatment with cell-depleting therapies, abatacept or rituximab \n\n active current or history of recurrent infection, or any major episode of infection requiring hospitalization or treatment with iv antibiotics <4 weeks or oral antibiotics <2 weeks prior to screening", - "brief_summary": "This study will assess the onset and maintenance of effect of tocilizumab on relief in patients with active moderate or severe rheumatoid arthritis who have had an inadequate response to DMARDs or anti-TNF. For the first, double-blind, part of the study patients will be randomized to receive an iv infusion of either 8mg/kg tocilizumab or placebo. After 4 weeks this will be followed by 11 months treatment with tocilizumab 8mg/kg iv infusion every 4 weeks. Methotrexate or DMARD therapy will be continued throughout study treatment. Target sample size is >100.", - "NCTID": "NCT00977106" - }, - { - "brief_title": "A Double-blind, Randomised, Parallel Group,Comparative Study With Rose-hip Liquid and Placebo Given to Healthy Volunteers in the Winter Season Aiming to Evaluate the Occurences of Flu and Catching a Cold", - "phase": "Phase 3", - "drugs": "['Rose hip Liquid']", - "drugs_list": [ - "Rose hip Liquid" - ], - "diseases": "['Flu', 'Common Cold']", - "diseases_list": [ - "Flu", - "Common Cold" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n First Men and women aged 50 + years \n\n It is accepted that the subjects can be treated for medical diseases. \n\n It is also accepted that the subjects receiving daily medication such as diuretics and medication for Hypertension, hypercholesterolemia and blood glucose-lowering treatment, medicine that strengthens the heart, symptom-relieving medication for joint disease, etc. \n\n Subjects may also use n-3 fatty acids (fish oil), as long as the fixed dosage. \n\n ", - "exclusion_criteria": ": \n\n Subjects who have been treated with rose hip extracts or powder within 3 months before screening. \n\n Subjects who have been treated with ginger, avocado / soy, large doses of vitamins (including vitamin C) or other known dietary supplements within 3 months before screening \n\n Subjects that have been deemed to be have a hard time collaboration \n\n Subjects who abuse narcotics. \n\n Subjects who abuse alcohol \n\n Subjects with a current mental illness \n\n Subjects with known allergy to rose hips \n\n Subjects participating in another clinical trial, or have participated in another clinical trial within 3 months before this trial started.", - "brief_summary": "The trial is an investigator-initiated, double-blind, randomized, placebo-controlled phase III study.~After the patient has receiving information about the study and after given written informed consent, the patient will be screened.~The patient's medical history and demographic information will be recorded. The patient will then be asked questions in accordance to the study questionnaires, and they will also be asked to complete questionnaires regarding quality of life - and finally they be instructed on how to complete the diary.~All patients are randomized to receive standardized rose hip liquid or matching placebo. The subject is instructed to take the liquid form of rose hips in the morning and evening meal. The subject will also be advised to call the clinic if there is an acute attack of cold and / or flu because they must then increase the in-take of study treatment to 3 double dose for 5 days and then return to normal dose.~The subject will then be asked a series of questions under study questionnaires, and be instructed in how questionnaires (SF-12) and diary filled. This is to provide security to the validation output values Investigator or study nurse will take telephone contact with the subject once a month, subjects will be asked about how things are going and to remember to take the liquid and whether they have completed the diary.~The last patient visit will take place after 6 months. Any side effects will be reported to and reviewed with HybenVital ApS in collaboration with medical experts.", - "NCTID": "NCT01459952" - }, - { - "brief_title": "Study of Tocilizumab to Treat Polymyalgia Rheumatica", - "phase": "Phase 2", - "drugs": "['Tocilizumab']", - "drugs_list": [ - "Tocilizumab" - ], - "diseases": "['Polymyalgia Rheumatica (PMR)']", - "diseases_list": [ - "Polymyalgia Rheumatica (PMR)" - ], - "enrollment": "10.0", - "inclusion_criteria": "Disease- Specific inclusion criteria: \n\n Patients must meet the following inclusion criteria to be eligible for study entry: \n\n Diagnosed with polymyalgia rheumatica and enrolled within one month of diagnosis. \n\n Disease Specific ", - "exclusion_criteria": ": \n\n Patients will be excluded from the study based on the following criteria: \n\n Symptoms or diagnosis of temporal arteritis, including headache, jaw claudication, hyperesthesia of scalp, abnormal palpated temporal artery, visual disturbances, temporal artery biopsy positivity \n\n Concurrent rheumatoid arthritis \n\n Presence of rheumatoid factor and CCP \n\n Other inflammatory arthritis or other connective tissue diseases, such as but not limited to systemic lupus erythematosus, systemic sclerosis, vasculitis, polymyositis, dermatomyositis, mixed connective tissue disease \n\n Treatment of polymyalgia rheumatica with more than 20mg of daily prednisone or its equivalent at the time of screening \n\n Treatment with more than 30mg of daily prednisone or its equivalent since diagnosis. Treatment with 30mg of daily prednisone or its equivalent since diagnosis for more than 2 weeks. \n\n More than 4 weeks of corticosteroid therapy prior to enrollment \n\n History of bowel perforation within the past five years. \n\n Active diverticulitis. \n\n Pre-existing or recent onset demyelinating disorders", - "brief_summary": "This is a fifteen-month open label, Phase IIa clinical trial is being conducted to assess the tolerability, safety and efficacy of a medication called Tocilizumab (Actemra\u00ae) in patients with polymyalgia rheumatica (PMR).", - "NCTID": "NCT01396317" - }, - { - "brief_title": "Impact of Literacy Level on Patient Education and Health Among People With Arthritis", - "phase": "Phase 2", - "drugs": "['11th grade reading level arthritis materials', 'Interactive in-person arthritis education']", - "drugs_list": [ - "11th grade reading level arthritis materials", - "Interactive in-person arthritis education" - ], - "diseases": "['Rheumatoid Arthritis', 'Psoriatic Arthritis', 'Polyarthritis']", - "diseases_list": [ - "Rheumatoid Arthritis", - "Psoriatic Arthritis", - "Polyarthritis" - ], - "enrollment": "134.0", - "inclusion_criteria": "inclusion criteria: \n\n Native English speaker \n\n Patient at the Rheumatology Clinic at Brigham and Women's Hospital, Boston, Massachusetts \n\n Diagnosis of rheumatoid arthritis, psoriatic arthritis, or seronegative polyarthritis", - "exclusion_criteria": "", - "brief_summary": "People with poor literacy may have worse health and less knowledge about how to manage their disease than patients at high reading levels. Patients with arthritis usually receive information on how to manage their disease that is written at an 11th grade reading level. The purpose of this study is to compare the health outcomes of patients with arthritis given either standard 11th grade level materials or interactive, in-person arthritis education along with materials written at a lower reading level.", - "NCTID": "NCT00023205" - }, - { - "brief_title": "Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)", - "phase": "", - "drugs": "['etanercept', 'methotrexate (MTX)']", - "drugs_list": [ - "etanercept", - "methotrexate (MTX)" - ], - "diseases": "['Rheumatoid Arthritis']", - "diseases_list": [ - "Rheumatoid Arthritis" - ], - "enrollment": "1754.0", - "inclusion_criteria": "inclusion criteria: \n\n The Test Group will be patients with rheumatoid arthritis, newly starting therapy with etanercept (Enbrel). inclusion criteria for the exposed cohort subjects are: \n\n Patients aged 18 years and over at the time of diagnosis; \n\n Patients from the BSRBR with moderate RA as defined by a DAS28 (>3.2 and \u22645.1); \n\n Patients who have given informed consent for long term follow-up and access to all medical records; \n\n Patients initiating (i.e. at leats one treatment) treatment with etanercept (Enbrel) for RA. \n\n The Control Group: \n\n Patients aged 18 years and over a the time of diagnosis; \n\n Patients from the BSRBR with moderate RA as defined by a DAS28 (>3.2 and \u22645.1); \n\n Patients who have given informed consent for long term follow-up and access to all medical records; Patients are receiving at least one traditional DMARD and have never been prescribed a biologic agent; \n\n ", - "exclusion_criteria": ": \n\n Per BSRBR registry since data is retropsectively being analyzed", - "brief_summary": "To assess the baseline (i.e. RA therapy initiation) characteristics in a real-world setting across two moderate RA cohorts: a Test Group of patients newly exposed to etanercept (Enbrel) therapy and a Control Group of patients with similar disease characteristics newly exposed to other, non-biologic therapies.~To assess the change over time (from baseline to the most recent follow-up) in the characteristics described at baseline in 2 British Society for Rheumatology Biologics Register (BSRBR) cohorts (i.e. moderate RA patients treated with Disease modifying anti-rheumatic drugs (DMARDs) alone versus moderate RA patients treated with Enbrel).", - "NCTID": "NCT01557322" - }, - { - "brief_title": "Current Adoption of Composite Indices in Evaluating Rheumatoid Arthritis Patients: An Observational Study", - "phase": "", - "drugs": "['As per routinary clinical care']", - "drugs_list": [ - "As per routinary clinical care" - ], - "diseases": "['Rheumatoid Arthritis']", - "diseases_list": [ - "Rheumatoid Arthritis" - ], - "enrollment": "293.0", - "inclusion_criteria": "inclusion criteria: \n\n Eighteen years of age or older with diagnosis of RA based on the 1987 American College of Rheumatology (ACR) criteria and in accordance with local guidelines. \n\n Patients eligible to anti-TNF therapy \n\n Patients na\u00efve to anti-TNFa drugs \n\n Patients with radiography (hands and feet) executed by 6 months before the baseline or at baseline according to modified Sharp Van der Hejde method [Sharp JT et al. 1985; Sharp JT. Et al. 1989; Van der Heijde DM et al. 1989] Patients capable of understanding and completing the questionnaire Patients capable of understanding and signing an informed consent form \n\n ", - "exclusion_criteria": ": \n\n Patients with tumors \n\n Patients already included in clinical trials", - "brief_summary": "This is an observational study of composite indices, including the CLARA (CLinical ARthritis Activity) index, in rheumatoid arthritis (RA) patients in routine clinical practice in Italy in order to evaluate clinical remission and low disease activity. Data will be collected only from patients providing informed consent. In this study we aimed to assess the psychometric properties of a new composite instrument termed CLinical ARthritis Activity (PRO-CLARA) that uses only three PRO measures from among the 7 ACR Core Data Set. We hypothesized that this index would facilitate rapid and easy RA activity assessment in daily routine.", - "NCTID": "NCT00793403" - }, - { - "brief_title": "Interferon-lambda: Novel Biologics for Controlling Neutrophil-mediated Pathology in Rheumatic Diseases?", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Arthritis', 'Vasculitis']", - "diseases_list": [ - "Arthritis", - "Vasculitis" - ], - "enrollment": "85.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy volunteer or \n\n Recent diagnosis of rheumatoid arthritis within 1 month or \n\n New diagnosis of giant cell arteritis within 1 month or \n\n New diagnosis of anti-neutrophil cytoplasm antibody associated vasculitis within 1 month or \n\n Flare of anti-neutrophil cytoplasm antibody associated vasculitis within one month \n\n ", - "exclusion_criteria": ": \n\n Unable to provide written informed consent", - "brief_summary": "Neutrophils emerge as key immune cells in the initiation and perpetuation of immune responses in autoimmune diseases. They display marked abnormalities in phenotype and function in various autoimmune diseases, including systemic vasculitis, systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA).~These neutrophils are characterised by an extended life span, increased capacity to produce reactive oxygen species, active gene expression and release of extracellular traps. Consequently, there is a need for better understanding of neutrophil phenotype and functions in these conditions, as well as for identifying molecules capable of specifically manipulating neutrophil function. The investigators have recently discovered that interferon lambdas (IFN-\u03bbs), also known as interleukin 28 (IL28) and interleukin 29 (IL29), class II cytokines with previously studied anti-viral biological functions, specifically suppress neutrophil infiltration and interleukin-1\u03b2 production and thereby, halt and reverse the development of collagen induced arthritis (CIA). The investigators propose to further investigate the cellular and molecular mechanisms behind this suppression and examine the translational potential of the investigators' finding by examining the IFN-\u03bb receptor expression and function in neutrophils isolated from the blood of healthy donors and rheumatic patients (early rheumatoid arthritis and vasculitis).", - "NCTID": "NCT02498808" - }, - { - "brief_title": "Clinical and Radiographic Outcomes of the Corin Tri-Fit Total Hip Replacement", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Osteoarthritis of Hip', 'Congenital Hip Dysplasia', 'Avascular Necrosis']", - "diseases_list": [ - "Osteoarthritis of Hip", - "Congenital Hip Dysplasia", - "Avascular Necrosis" - ], - "enrollment": "37.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients scheduled for primary, unilateral total hip replacement (THR) with no previous history of hip replacement and/or fracture surgery. \n\n Patients with arthritis secondary Noninflammatory Degenerative Joint Diseases (NIDJD), including osteo/degenerative arthritis, congenital hip dysplasia, and avascular necrosis. \n\n Patients who do not meet any of the ", - "exclusion_criteria": ". \n\n ", - "brief_summary": "The study will evaluate the radiographs (x-rays) of 100 patients with a TriFIT total hip at 2 weeks, 3 months, 6 months, 12 months, and yearly following surgery to see if there has been any movement or wear in the hip stem over the course of the study. The study will also record clinical data on each patient using various functional tests and questionnaires at the same intervals.", - "NCTID": "NCT02162186" - }, - { - "brief_title": "Study Evaluating the Cost of the Treatments of the Refractory Psoriatic Arthritis to the Conventional Therapy", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Arthritis, Psoriatic, Psoriasis']", - "diseases_list": [ - "Arthritis", - "Psoriatic", - "Psoriasis" - ], - "enrollment": "107.0", - "inclusion_criteria": "inclusion criteria: \n\n Eighteen years of age or older \n\n Inflammatory arthropathy associated with psoriasis meet the ACR criteria for PsA \n\n Patients with diagnosis of active and progressive PsA who have failure with conventional treatments \n\n ", - "exclusion_criteria": ": \n\n Significant concurrent medical diseases including cancer or a history of cancer, uncontrolled congestive heart failure, myocardial infarctions within 12 months or other clinically significant cardiovascular diseases, immunodeficiency syndromes or concomitant infectious diseases.", - "brief_summary": "The purpose of this study is to conduct an economic analysis on the cost of conventional therapy as compared to biologic therapy and the direct/indirect costs of disease management in patients with refractory psoriatic arthritis (PsA). Primary outcomes are to qualify the economic burden of refractory PsA care. The secondary outcomes are to assess efficacy, safety, and cost effectiveness of different therapies.", - "NCTID": "NCT00303186" - }, - { - "brief_title": "A Study on Assessment of STELARA and Tumor Necrosis Factor Alpha Inhibitor Therapies in Participants With Psoriatic Arthritis", - "phase": "", - "drugs": "['No Intervention']", - "drugs_list": [ - "No Intervention" - ], - "diseases": "['Psoriatic Arthritis']", - "diseases_list": [ - "Psoriatic Arthritis" - ], - "enrollment": "991.0", - "inclusion_criteria": "inclusion criteria: \n\n Must have a confirmed diagnosis of psoriatic arthritis (PsA) as determined by a rheumatologist according to ClASsification criteria for Psoriatic Arthritis (CASPAR) criteria \n\n Must be starting either STELARA or any new approved tumor necrosis factor alpha inhibitor (TNFi) (including TNFi biosimilar) as a new biologic disease-modifying antirheumatic drug (bDMARD) therapy in a first, second or third line of bDMARD therapy for PsA at the time of enrollment into the observational study or within a maximum 2-month window after the baseline visit \n\n Must sign a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements \n\n ", - "exclusion_criteria": ": \n\n Participant is starting STELARA or a TNFi therapy as fourth or further line of biologic treatment \n\n Participant is unwilling or unable to participate in long-term data collection \n\n Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or the first data collection time point \n\n Participant is currently enrolled in an interventional study", - "brief_summary": "The purpose of this study is to evaluate treatment retention in psoriatic arthritis participants with STELARA or tumor necrosis factor alpha inhibitor (TNFi) therapies in relation to effectiveness, safety, benefit/risk and to examine clinical response.", - "NCTID": "NCT02627768" - }, - { - "brief_title": "Rituximab in Systemic Sclerosis", - "phase": "Phase 2; Phase 3", - "drugs": "['Rituximab', 'Placebo (NaCl)']", - "drugs_list": [ - "Rituximab", - "Placebo (NaCl)" - ], - "diseases": "['Systemic Sclerosis']", - "diseases_list": [ - "Systemic Sclerosis" - ], - "enrollment": "22.0", - "inclusion_criteria": "inclusion criteria: \n\n Systemic sclerosis fulfilling ACR or LeRoy's criteria \n\n Active polyarthritis defined by > 6/53 tender joints and > 4/53 swollen joints \n\n Ongoing first line therapy by prednisone (max 10 mg/d) and DMARDS (methotrexate, leflunomide, azathioprine or mycophenolate) \n\n Birth control if applicable \n\n ", - "exclusion_criteria": ": \n\n Overlap syndrome defined by clinical symptoms and positive specific auto-antibodies (anti-CCP, anti-SSA, anti-DNA DNA anti-Sm) (Rheumatoid factors and anti-RNP are not ", - "brief_summary": "The purpose of this study is to determine whether rituximab is effective in the treatment of articular symptoms that occur in systemic sclerosis related polyarthritis", - "NCTID": "NCT01748084" - }, - { - "brief_title": "Rheumatic Heart Disease School Project", - "phase": "", - "drugs": "['Echocardiography']", - "drugs_list": [ - "Echocardiography" - ], - "diseases": "['Rheumatic Heart Disease']", - "diseases_list": [ - "Rheumatic Heart Disease" - ], - "enrollment": "8519.0", - "inclusion_criteria": "inclusion criteria: \n\n Schoolchildren in Southeast Nepal aged 5-16 years \n\n Written informed consent by the principal of the school \n\n Passive consent from the parents \n\n ", - "exclusion_criteria": " \n\n No formal ", - "brief_summary": "Acute rheumatic Fever (ARF) results from an autoimmune response due to molecular mimicry between the M-protein on the group A \u03b2-hemolytic streptococci (GABHS) cell membrane and cardiac myosin, and may lead through recurrent or sustained inflammation to Rheumatic Heart Disease (RHD). RHD remains a major contributor to morbidity and premature death in the working age population in Nepal. Secondary prevention with regular oral or intravenous administration of penicillin continued until early adulthood is recommended to prevent the progression of the development of endocarditis and subsequent valvular dysfunction.~Screening for rheumatic heart disease using echocardiography has the potential to detect rheumatic valvular lesions at an earlier, clinically silent stage, as compared to clinical examination alone and might have a beneficial impact on long-term outcome of children with RHD. Schoolchildren aged 5-16 years from several public and private schools from rural and urban areas in Southeastern Nepal will be screened for RHD using portable echocardiography.~Three main inter-related objectives will be pursued in three phases of the study: In a first phase using a cross sectional approach, the prevalence of clinical and subclinical RHD will be investigated among a representative sample of schoolchildren from public and private schools in urban and rural areas. In a second phase, using a cohort study approach among those children diagnosed at different stages of RHD, clinical outcomes with regular medical surveillance will be assessed (a), and clinical and social risk factors associated with prognosis of the disease after receiving medical care at various stages of disease at diagnosis will be determined (b). A third phase will integrate the prevalence rates from phase 1 and the clinical outcomes from phase 2 in a mathematical model to assess the impact of screening and RHD treatment on health resource utilization.", - "NCTID": "NCT01550068" - }, - { - "brief_title": "Study Comparing Etanercept (ETN) Against a Placebo for Etanercept on a Background Nonsteroidal Anti Inflammatory Drug (NSAIDs) in the Treatment of Early Spondyloarthritis (SpA) Patients Who do Not Have X-ray Structural Changes", - "phase": "Phase 3", - "drugs": "['etanercept', 'Background NSAID', 'PLACEBO', 'Background NSAID']", - "drugs_list": [ - "etanercept", - "Background NSAID", - "PLACEBO", - "Background NSAID" - ], - "diseases": "['Spondylitis, Ankylosing']", - "diseases_list": [ - "Spondylitis", - "Ankylosing" - ], - "enrollment": "225.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of axial spondyloarthritis as defined by Assessments in Ankylosing Spondylitis (ASAS)criteria \n\n Active symptoms defined as Ankylosing Spondylitis Disease Activity Index{BASDAI) > or = 4 \n\n Axial symptoms of back pain with a less than favorable response to on steroidal anti inflammatory drugs at optimal dosage for greater than 4 weeks \n\n ", - "exclusion_criteria": ": \n\n Evidence of current or recent episode of uveitis \n\n Evidence of IBD flare within 6 months \n\n Previous treatment with an anti Tumor necrosis factor(TNF) \n\n Active tuberculosis \n\n Radiographic sacroiliitis grade 3-4 unilaterally or >= 2 bilaterally", - "brief_summary": "This is a two part study. During period one there will be a comparison of Etanercept (ETN) against a placebo with both arms maintaining the background anti inflammatory drug prescribed by their Physician. The hypothesis is that Etanercept will be superior to the placebo arm as determined by the proportion of subjects achieving Assessments in Ankylosing Spondylitis (ASAS)40 improvement at 12 weeks. This will be followed by 92 weeks extension where everyone in the trial receives Etanercept (ETN) and a background non steroidal anti inflammatory drug(NSAID).", - "NCTID": "NCT01258738" - }, - { - "brief_title": "A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis", - "phase": "Phase 4", - "drugs": "['etanercept', 'etanercept', 'placebo']", - "drugs_list": [ - "etanercept", - "etanercept", - "placebo" - ], - "diseases": "['Axial Spondyloarthritis']", - "diseases_list": [ - "Axial Spondyloarthritis" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female subjects aged 18 years and over at the time of consent to the study. \n\n Diagnosis of SpA, as defined by the ASAS criteria for axial SpA \n\n Axial involvement refractory to previous or current intake of NSAIDs, defined as at least 2 NSAIDs at maximum tolerated dose determined from past medical history taken for a duration of > 1 month (for both NSAIDs combined) before the Screening visit. \n\n Active axial involvement defined by mini BASDAI \n\n ", - "exclusion_criteria": ": \n\n Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial. \n\n Subjects who have received any previous treatment with etanercept or other TNF\u03b1 inhibitors or biologic agents. \n\n Subjects with a known or expected allergy, contraindication, or hypersensitivity to etanercept or its excipients.", - "brief_summary": "This study will compare the Non Steroidal Anti-Inflammatory Drugs (NSAIDs) sparing effect of etanercept with that of placebo in adult subjects with axial Spondyloarthritis.", - "NCTID": "NCT01298531" - }, - { - "brief_title": "Operative Versus Conservative Treatment of Scaphoid Fractures", - "phase": "Phase 4", - "drugs": "['Scaphoid screw']", - "drugs_list": [ - "Scaphoid screw" - ], - "diseases": "['Scaphoid Fracture']", - "diseases_list": [ - "Scaphoid Fracture" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Mature skeleton \n\n Isolated, acute complete fracture of the mid third of the scaphoid \n\n ", - "exclusion_criteria": ": \n\n acute fractures of both hands \n\n one hand missing \n\n other injuries than scaphoid fractures \n\n rheumatoid, osteoarthritis or polyarthritis \n\n previous soft tissue injuries of the hand \n\n drug or alcohol abuse \n\n participant in trial during the previous month", - "brief_summary": "The aim of this study is to compare the time to return to previous activity~level between operative treatment and non-operative cast immobilization of~patients with an acute complete fracture of the middle part of the scaphoid,~without any dislocation or comminution visible CT-scan.", - "NCTID": "NCT00205985" - }, - { - "brief_title": "Tremelimumab and CP-870,893 in Patients With Metastatic Melanoma", - "phase": "Phase 1", - "drugs": "['CD40 agonist monoclonal antibody CP-870,893', 'tremelimumab', 'laboratory biomarker analysis']", - "drugs_list": [ - "CD40 agonist monoclonal antibody CP-870,893", - "tremelimumab", - "laboratory biomarker analysis" - ], - "diseases": "['Recurrent Melanoma', 'Stage IV Melanoma']", - "diseases_list": [ - "Recurrent Melanoma", - "Stage IV Melanoma" - ], - "enrollment": "25.0", - "inclusion_criteria": "Inclusion \n\n Patients with metastatic melanoma who have measurable disease \n\n ECOG PS 0 or 1 \n\n Adequate bone marrow function \n\n WBC >= 3,000 \n\n Hgb >= 9 \n\n Plt >= 100 \n\n Adequate hepatic function, defined by the following parameters: \n\n Total bilirubin WNL unless associated with hepatobiliary metastases or Gilbert syndrome, then total bilirubin =< 2 x ULN \n\n Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN unless associated with hepatic metastases, then ALT and AST =< 5 x ULN \n\n Signed, written informed consent \n\n Exclusion \n\n Previous treatment with any other compound that targets CD40 or CTLA4 \n\n Concurrent treatment with any anticancer agent outside of this protocol \n\n Prior allogeneic bone marrow transplant \n\n History of brain metastases, even if previously treated \n\n History of autoimmune disorder, including type 1 diabetes mellitus, pemphigus vulgaris, systemic mastocytosis, systemic lupus erythromatosis, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjorgen's syndrome, vasculitis/arteritis, Behcet's syndrome, autoimmune thyroiditis, multiple sclerosis, or uveitis \n\n History of chronic inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, or current acute colitis or enterocolitis of any etiology \n\n History of diverticulitis (even a single episode) or evidence at baseline, including evidence limited to CT scan only. Note diverticulosis is not an exclusion criterion per se. \n\n History (within the previous year) of stroke or transient ischemic attack, unstable angina, myocardial infarction, congestive heart failure \n\n History of deep venous thrombosis or migratory thrombophlebitis (Trousseau) \n\n Hereditary or acquired coagulopathies (e.g., hemophilia, von Willebrand's disease, or cancer-associated DIC) \n\n Prior allergic reactions attributed to other monoclonal antibodies \n\n Concurrent or planned concurrent treatment with systemic high dose (immunosuppressive) corticosteroids or treatment with systemic corticosteroids within 4 weeks of baseline \n\n Treatment on another therapeutic clinical trial within 4 weeks of enrollment in this trial \n\n Concurrent or planned concurrent treatment with anticoagulants such as Coumadin or heparin, except to maintain patency of in-dwelling catheters \n\n Ongoing or active infection; treatment with systemic antibiotics or antifungals for ongoing or recurrent infection (topical use of antibiotics or antifungals is allowed) \n\n Pregnancy or breast-feeding; female patients must be surgically sterile, be postmenopausal, or must agree to use effective contraception during the period of therapy and for 12 months following the last dose of either tremelimumab or CP-870,893; all female patients with reproductive potential must have a negative pregnancy test prior to enrollment \n\n Other uncontrolled, concurrent illness that would preclude study participation; or, psychiatric illness or social challenges that would entail unreasonable risk or preclude informed consent or compliance with study procedures", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Monoclonal antibodies, such as tremelimumab and CD40 agonist monoclonal antibody CP-870,893, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving tremelimumab together with CD 40 agonist monoclonal antibody CP-870, 893 may kill more tumor cells.~PURPOSE: This phase I trial is studying the side effects and best dose of giving tremelimumab together with CD40 agonist monoclonal antibody CP-870,893 in treating patients with metastatic melanoma.", - "NCTID": "NCT01103635" - }, - { - "brief_title": "Surveillance of Streptococcal Infections in Children in India", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Group A Beta Hemolytic Streptococcal (GAS) Infection']", - "diseases_list": [ - "Group A Beta Hemolytic Streptococcal (GAS) Infection" - ], - "enrollment": "663.0", - "inclusion_criteria": "inclusion criteria: \n\n All students (approximately 225-250) attending four classes in four rural schools, grades 2-5, in rural villages near Chandigarh, and all students in classes 2-6 approximately 225-250 attending one rural village school near Vellore were asked to participate. \n\n Approximately an equal number of boys and girls participated. \n\n Selection of the schools for the study was determined by such factors as the accessibility to a rural regional clinic, housing facilities for medical staff, and passable tertiary roads to the villages and the schools. \n\n ", - "exclusion_criteria": ": \n\n All volunteers had a history of acute rheumatic fever and acute glomerulonephritis and evidence of rheumatic fever and rheumatic heart disease on physical examination at the initial survey were excluded from the study. \n\n Excluded also was a child with a compromising illness such as cystic fibrosis that might require frequent or intermittent antibiotic treatment.", - "brief_summary": "Information from this study is needed to plan an eventual trial of a GAS vaccine in India if and when one is available. A GAS vaccine is currently a priority of the Indian Council for Medical Research (ICMR), and this project has been approved by the Joint Working Group (US and Indian Delegates) of the Vaccine Action Program, a joint effort of the ICMR and NIAID to implement cooperative efforts between the two countries on mutual objectives in vaccine development. Currently, several GAS vaccines are in development, supported by NIAID, and other sources, and one candidate is in phase one clinical trial authorized by the FDA. Information on the antigenic structure of GAS isolated in India will be needed for planning vaccine composition. It is the view of the Indian Ministry of Health and Indian Council for Medical Research that eventual prevention and control of rheumatic fever and rheumatic heart disease in India, now a heavy burden on the children will require a GAS vaccine, which requires both access to primary health care and a vaccine if and when it is available.~Information on incidence is needed to determine the size of a future vaccine cohort in order to obtain a statistically significant result on vaccine efficacy. Although unrelated to vaccine development, information on the incidence of GAS pharyngitis is needed in India to implement primary and secondary acute rheumatic fever (ARF) and rheumatic heart disease (RHD) prevention programs as were implemented in the USA and Europe forty years ago.~A vaccine trial is not part of this study, nor is there any intervention, other than antibiotic treatment of all children volunteers who develop GAS pharyngitis or impetigo.~An additional point should be made about the importance of obtaining epidemiological data on streptococcal disease in India, and on the emm types of GAS that cause infections. The population of India is over one billion people, representing nearly twenty five percent of the world's population. Information on GAS epidemiology from India is scant to say the least, and it is sorely needed. We now know that streptococcal toxic shock syndrome and fasciitis that have occurred in the U. S., Europe, Australia, and Japan, with greater frequency in recent years are caused by several genetically similar emm types of GAS. The implication of such genetic and epidemiologic data is that these genetically related strains have spread worldwide, Current information from India is far too limited to know if these virulent strains of GAS occur in India, and if they do, to what extent might they be the cause of frequent invasive disease in hospitalized patients.~Equally important, we do not know if a potentially high virulent GAS strain is currently emerging in some locale(s) in India, and what possible threat it might become, if it were to be transported to other worldwide geographic regions. Although not a specific aim of this proposal, the surveillance conducted to accomplish the aims of this protocol will provide essential information on the possible emergence of an unexpected emm type with pathogenic potential.~...", - "NCTID": "NCT00342199" - }, - { - "brief_title": "Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region", - "phase": "Phase 4", - "drugs": "['Etanercept , Methotrexate', 'Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide']", - "drugs_list": [ - "Etanercept ", - "Methotrexate", - "Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide" - ], - "diseases": "['Rheumatoid Arthritis']", - "diseases_list": [ - "Rheumatoid Arthritis" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of RA \n\n Currently receiving an adequate dose of methotrexate (MTX) for treatment of RA \n\n Active RA at time of screening and baseline \n\n ", - "exclusion_criteria": ": \n\n Previous or current treatment with etanercept (ETN), other tumor necrosis factor-alpha inhibitors, or other biologic agents \n\n Concurrent treatment with a DMARD, other than MTX, at screening \n\n Receipt of any DMARD, other than MTX, within 3 months before screening", - "brief_summary": "The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.", - "NCTID": "NCT00422227" - }, - { - "brief_title": "Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis", - "phase": "Phase 4", - "drugs": "['Etanercept (Enbrel)', 'Placebo']", - "drugs_list": [ - "Etanercept (Enbrel)", - "Placebo" - ], - "diseases": "['Ankylosing Spondylitis']", - "diseases_list": [ - "Ankylosing Spondylitis" - ], - "enrollment": "82.0", - "inclusion_criteria": "inclusion criteria \n\n Active and severe ankylosing spondylitis \n\n Ankylosing spondylitis refractory to standard anti-rheumatic treatment \n\n Between 18 and 70 years of age \n\n ", - "exclusion_criteria": " \n\n Prior exposure to any TNF-inhibitor, including etanercept \n\n DMARDs (other than hydroxychloroquine, methotrexate and sulphasalazine) within 4 weeks of study drug initiation \n\n Dose of NSAIDs changed within two weeks of study drug initiation", - "brief_summary": "Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis.", - "NCTID": "NCT00420238" - }, - { - "brief_title": "Short Term Efficacy of a Starting Dose of 12.5 mg of Prednisone in Polymyalgia Rheumatica Patients", - "phase": "Phase 4", - "drugs": "['prednisone']", - "drugs_list": [ - "prednisone" - ], - "diseases": "['Polymyalgia Rheumatica']", - "diseases_list": [ - "Polymyalgia Rheumatica" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n patients with PMR, diagnosed according to the criteria of Bird et al \n\n ", - "exclusion_criteria": ": \n\n patients with arthritis \n\n patients with giant cell arteritis \n\n patients with Parkinson's disease \n\n patients with hypothyroidism \n\n patients with scapulohumeral periarthritis \n\n patients with fibromyalgia \n\n patients unable to cooperate", - "brief_summary": "Polymyalgia rheumatica (PMR) is a common inflammatory condition affecting elderly people and involving the girdles. The mainstay of treatment is oral glucocorticoids (GC), with the recent BSR-BHPR guidelines suggesting an initial prednisone dose comprised between 15 and 20 mg as appropriate. However, probably because of the dramatic response of PMR to GC, randomized controlled trials of treatment are lacking. As a result, there is no evidence from controlled studies on the efficacy of different initial doses or drug tapering. Objective of the study: to test if 12.5 mg prednisone/day is an adequate starting dose in polymyalgia rheumatica (PMR) and to evaluate clinical predictors of drug response.~Methods: 60 consecutive PMR patients will be treated with a starting dose of 12,5 mg/day prednisone. Clinical, laboratory, and ultrasonographic features will be recorded as possible predictors of response to prednisone. Remission is defined as disappearance of at least 75% of the signs and symptoms of PMR and normalization of ESR and CRP within the first month, a scenario allowing steroid tapering.", - "NCTID": "NCT01169597" - } - ], - "1": [ - { - "brief_title": "RhEumatiC Heart diseAse Genetics", - "phase": "", - "drugs": "['Next generation sequencing']", - "drugs_list": [ - "Next generation sequencing" - ], - "diseases": "['Rheumatic Heart Disease']", - "diseases_list": [ - "Rheumatic Heart Disease" - ], - "enrollment": "1000.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical and echocardiographic signs of RHD using WHF criteria \n\n ", - "exclusion_criteria": ": \n\n Congenital heart disease", - "brief_summary": "Rheumatic fever (RF) is an autoimmune disease that is mediated by the cellular and humoral immune response that follows an untreated pharyngeal Streptococcus pyogenes infection. The most serious complication is rheumatic heart disease (RHD), one of the most common problems facing children and young adults worldwide, which leads to chronic valvular lesions. It is estimated that 60% of all acute rheumatic fever cases will develop RHD.~The pathogenesis of RHD is complex with both environmental and genetic factors contributing to its etiology. The investigators know little about the genetic etiology, cellular events and modifiers of progression of RHD, and there exists a wide range of disease severity and progression to severe valve pathology.~Thus, the investigators will study the genetics of RHD in Rwanda, a country with a very high incidence of RHD, using a combination of next-generation targeted exome capture, transcriptomics, and expressed quantitative trait loci (eQTL) analysis.", - "NCTID": "NCT02118818" - }, - { - "brief_title": "Efficacy of BLIS K12 as Preventive Measure for Rheumatic Children", - "phase": "", - "drugs": "['Streptococcus Salivarius BLIS K12']", - "drugs_list": [ - "Streptococcus Salivarius BLIS K12" - ], - "diseases": "['Rheumatic Fever']", - "diseases_list": [ - "Rheumatic Fever" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Rheumatic heart disease with recommended strep prophylaxis \n\n ", - "exclusion_criteria": ": \n\n less than one year from first diagnosis \n\n refusal to take the tablets", - "brief_summary": "The purpose of this study is to determine whether daily treatment with Streptococcus Salivarius BLIS K-12 prevents streptococcal throat infection in children that have had an episode of rheumatic fever.", - "NCTID": "NCT02407106" - }, - { - "brief_title": "Genetic Susceptibility to Rheumatic Heart Disease in the Pacific Region", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Rheumatic Heart Disease', 'Mitral Stenosis']", - "diseases_list": [ - "Rheumatic Heart Disease", - "Mitral Stenosis" - ], - "enrollment": "2372.0", - "inclusion_criteria": "Cases \n\n inclusion criteria: \n\n Diagnosis of rheumatic heart disease based on one of: \n\n World Heart Federation definite echocardiographic criteria \n\n World Heart Federation borderline echocardiographic criteria and history of acute rheumatic fever \n\n Mitral stenosis with valve area less than 2.0 cm2 \n\n Previous surgery for rheumatic heart disease \n\n ", - "exclusion_criteria": ": \n\n Age less than five years \n\n Inability to give consent \n\n New Controls \n\n inclusion criteria: \n\n Healthy individual living in a community where cases were identified \n\n ", - "brief_summary": "The purpose of this study is to investigate whether there are genetic differences between patients with rheumatic heart disease and members of the general population.", - "NCTID": "NCT02188862" - } - ], - "2": [ - { - "brief_title": "Plasma Adiponectin Levels and Relations With Cytokines in Children With Acute Rheumatic Fever", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Acute Rheumatic Fever']", - "diseases_list": [ - "Acute Rheumatic Fever" - ], - "enrollment": "87.0", - "inclusion_criteria": "For the study subjects, diagnosis of ARF was made according to the Modified Jones criteria (4) and appropriate treatment was started. Patients were divided into three groups by clinical findings. Group 1 included patients with only chorea, while patients with arthritis and carditis were involved in Group 2 and patients with only carditis were included in the Group 3. A group with only arthritis was not established since the patients with isolated arthritis are usually followed up at primary and secondary healthcare facilities rather than referring those patients to our tertiary healthcare center.", - "exclusion_criteria": "", - "brief_summary": "We aimed to investigate if adiponectin facilitates diagnosis of ARF by analyzing adiponectin levels in acute and convalescent periods of the acute rheumatic fever and by comparing results with that of healthy control group; also by comparatively examining levels of adiponectin in ARF cases who had different clinical findings at presentation. In addition, we aimed to investigate its role in the pathogenesis of ARF by evaluating correlations with cytokines such as TNF-\u03b1, IL-6 and IL-8 and acute phase reactants.", - "NCTID": "NCT01886846" - } - ] - }, - { - "patient_id": "sigir-20156", - "patient": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", - "0": [ - { - "brief_title": "Thyroid Disorders in Malaysia: A Nationwide Multicentre Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Hypothyroidism', 'Subclinical Hypothyroidism', 'Hyperthyroidism', 'Subclinical Hyperthyroidism', 'Graves Disease', \"Hashimoto's Thyroiditis\", 'Iodine Deficiency', 'Genetic Susceptibility']", - "diseases_list": [ - "Hypothyroidism", - "Subclinical Hypothyroidism", - "Hyperthyroidism", - "Subclinical Hyperthyroidism", - "Graves Disease", - "Hashimoto's Thyroiditis", - "Iodine Deficiency", - "Genetic Susceptibility" - ], - "enrollment": "2498.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged equal or more than 18 years old at the time of sampling \n\n Malaysian citizen \n\n ", - "exclusion_criteria": ": \n\n Respondents who did not give consent", - "brief_summary": "This will be a population based study looking at the prevalence of thyroid disorders in Malaysia (including hypo- and hyperthyroidism, subclinical hypo- or hyperthyroidism) and its association with different ethnicity and iodine status. The study will also look at genetic susceptibility for autoimmune thyroid disorders in the Malaysian population~General hypotheses:~The prevalence of thyroid disorders in Malaysia is 10% for hypothyroidism and 2% for hyperthyroidism Hypo- and hyperthyroidism is associated with iodine status in our population There are different susceptibility gene for autoimmune thyroid disorder in different ethnicity in our population", - "NCTID": "NCT02190214" - }, - { - "brief_title": "Is a Low Thyreotropin Level Predictive of Recurrent Arrhythmia After Catheter Ablative Surgery?", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Atrial Fibrillation', 'Subclinical Hyperthyroidism']", - "diseases_list": [ - "Atrial Fibrillation", - "Subclinical Hyperthyroidism" - ], - "enrollment": "327.0", - "inclusion_criteria": "inclusion criteria: \n\n Atrial fibrillation or AV-nodal reentry tachycardia \n\n Fulfills criteria for ablation (severe arrhythmia symptoms; for atrial fibrillation patients, having tried at least one antiarrhythmic agent with poor effect) \n\n Admitted for ablation for the first time \n\n Has left blood samples for thyroid status (TSH, free T4, free T3) \n\n ", - "exclusion_criteria": ": \n\n Atrial flutter \n\n Overt hyperthyroidism", - "brief_summary": "Overt hyperthyroidism (so-called goiter in lay language) is a hormonal disturbance that is known to increase the risk of atrial fibrillation (a common heart arrhythmia with potentially severe consequences) in some patients. Previous research has indicated that even slight elevations in thyroid hormone levels - so called subclinical hyperthyroidism - may increase this risk. When atrial fibrillation and overt hyperthyroidism are found simultaneously in a patient, the hormonal imbalance must be treated first in order to later resolve the arrhythmia. It is unclear whether this strategy holds true for subclinical hyperthyroidism. Our two hypotheses are: 1) Subclinical hyperthyroidism is more prevalent in patients admitted for atrial fibrillation ablation than in the population as a whole, and 2) Patients with subclinical hyperthyroidism and atrial fibrillation benefit less from ablation than others.~As a control group, we have chosen patients admitted for ablation of AV-nodal Reentry Tachycardia at the same clinics as the cases. No correlation has ever been shown between AV-nodal Reentry Tachycardia and hyperthyroidism.", - "NCTID": "NCT01789541" - }, - { - "brief_title": "Maternal Autoimmune Thyroid Disease and Fetal Thyroxin", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pregnancy Complicated by Hyperthyroidism', 'Hypothyroidism in Pregnancy']", - "diseases_list": [ - "Pregnancy Complicated by Hyperthyroidism", - "Hypothyroidism in Pregnancy" - ], - "enrollment": "83.0", - "inclusion_criteria": "inclusion criteria: \n\n Autoimmune hyper or hypothyroidism, diagnosed by an endocrinologist, treated, based on clinical and laboratory tests and ultrasound thyroid examination. \n\n Patients were included if they were seen by gynecologist at Clinic for Gynecology up until 20th week of gestation and not later. \n\n 20 healthy pregnant women in control group were directed for cordocentesis due to age. \n\n ", - "exclusion_criteria": ": \n\n Any other chronic diseases.", - "brief_summary": "The purpose of this trial is to correlate fetal thyroid hormones from fetal cord blood with clinical (maternal antithyroid drug dose and antithyroid antibodies) and ultrasound (US) parameters of fetal thyroid function from pregnant mothers with autoimmune thyroid disease (AITD).", - "NCTID": "NCT01528904" - }, - { - "brief_title": "Follow-up Study of the RAI-Treated Hyperthyroid Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Hyperthyroidism', 'Cardiovascular Diseases', 'Atrial Fibrillation']", - "diseases_list": [ - "Hyperthyroidism", - "Cardiovascular Diseases", - "Atrial Fibrillation" - ], - "enrollment": "5222.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients: Radioiodine treatment for hyperthyroidism given in the Tampere University Hospital between January 1969 and June 2002 \n\n Controls: age- and gender-matched control subject identified for each patient from the Population Register Centre. The control subject had to be alive at the time when the patient received the first RAI treatment", - "exclusion_criteria": "", - "brief_summary": "Previous studies of hyperthyroid patients suggest that they remain at increased risk of cardiovascular morbidity after restoring euthyroidism.~The study objective is to compare the rate and causes of hospitalization of hyperthyroid patients treated with radioactive iodine (RAI) with those of an age- and gender-matched reference population in a long-term follow-up study.", - "NCTID": "NCT00471458" - }, - { - "brief_title": "Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter", - "phase": "", - "drugs": "['Total thyroidectomy', 'Dunhill operation', 'Bilateral subtotal thyroidectomy']", - "drugs_list": [ - "Total thyroidectomy", - "Dunhill operation", - "Bilateral subtotal thyroidectomy" - ], - "diseases": "['Goiter']", - "diseases_list": [ - "Goiter" - ], - "enrollment": "600.0", - "inclusion_criteria": "Inclusion Criterion \n\n a bilateral non-toxic multinodular goiter with normal appearing on ultrasound of the neck posterior aspects of both thyroid lobes. \n\n ", - "exclusion_criteria": ": \n\n multinodular goiter involving posterior aspect/s of thyroid lobe/s, \n\n suspicion of thyroid cancer, \n\n previous thyroid surgery, \n\n thyroiditis, \n\n subclinical or clinically overt hypothyroidism or hyperthyroidism, \n\n pregnancy or lactation, \n\n age < 18 years or > 65 years, \n\n ASA 4 grade (American Society of Anesthesiology), \n\n inability to comply with the follow-up protocol.", - "brief_summary": "The aim of this three-arm randomized study was to evaluate results of different thyroid resection modes among patients with bilateral multinodular non-toxic goiter, with special emphasis put on recurrence rate and morbidity rate, in a 5-year follow-up.", - "NCTID": "NCT00946894" - }, - { - "brief_title": "Rituximab (RTX) Therapy in Patients With Active TAO", - "phase": "Phase 4", - "drugs": "['Rituximab', 'Iv Methylprednisolone', 'peroral methylprednisolone and Methotrexate']", - "drugs_list": [ - "Rituximab", - "Iv Methylprednisolone", - "peroral methylprednisolone and Methotrexate" - ], - "diseases": "['Ophthalmopathy, Thyroid-Associated']", - "diseases_list": [ - "Ophthalmopathy", - "Thyroid-Associated" - ], - "enrollment": "26.0", - "inclusion_criteria": "inclusion criteria: \n\n \u25e6Man or woman between 18-70 years TAO with CAS of \u2265 4 (less than 3 months). \n\n Euthyroid for at least 6 weeks \n\n ", - "exclusion_criteria": ": \n\n Dysthyroid optic neuropathy (DON) \n\n Ulcerative Keratitis \n\n Previous treatment with steroids for TAO (do not include prophylaxis for TAO in connection with radio iodine treatment) \n\n Previous Treatment with Rituximab (MabThera\u00ae) \n\n Positive Hepatitis B or C serology. \n\n Receipt of a live vaccine within 4 weeks prior RTX+MTX to randomization \n\n History of recurrent significant infection or history of recurrent bacterial infections \n\n Patient who may not attend to the protocol according to the investigators opinion. \n\n Pregnancy or lactation \n\n Significant cardiac, including significant or uncontrolled arrhythmia, or pulmonary disease (including obstructive pulmonary disease). \n\n Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications \n\n Concomitant malignancies or previous malignancies. \n\n Previous active tuberculosis \n\n Alcoholism \n\n Alcoholic related liver disease or other chronical liver disease \n\n Bone marrow depression with leukopenia, thrombocytopenia or significant anemia \n\n Rheumatoid or other significant pulmonary disease \n\n Allergy to the active substance or any other substance in the medications or murine proteins \n\n Active, severe infections (such as tuberculosis, sepsis or opportunistic infections) \n\n Patients with severe immunosuppression \n\n Severe cardiac failure or severe uncontrolled heart disease", - "brief_summary": "Thyroid Associated Ophthalmopathy is condition affecting the eyes of about 10% of patients with Graves disease. Its combination of protrusion affecting the looks of the patient and pain is often severely affecting the quality of life among these patients.~The standard treatment for this illness today is intravenous glucocorticoids together with methotrexate. The purpose of this study is to evaluate the effect of rituximab on patients that do not respond to or relapse after conventional therapy.", - "NCTID": "NCT02378298" - }, - { - "brief_title": "A Study to Evaluate Efficacy of YM060 on Diarrhea-predominant Irritable Bowel Syndrome (D-IBS) in Female Patients", - "phase": "Phase 2", - "drugs": "['YM060', 'placebo']", - "drugs_list": [ - "YM060", - "placebo" - ], - "diseases": "['Irritable Bowel Syndrome']", - "diseases_list": [ - "Irritable Bowel Syndrome" - ], - "enrollment": "409.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients meeting the Rome III Diagnostic Criteria \n\n Loose (mushy) or watery stools within the last 3 months \n\n Abdominal discomfort and/or pain during their non-menstrual period \n\n ", - "exclusion_criteria": ": \n\n Patients with a history of surgical resection of the stomach, small intestine or large intestine \n\n Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative) \n\n Patients with a history or current diagnosis of colitis ischemic \n\n Patients with a current diagnosis of enteritis infectious \n\n Patients with a current diagnosis of hyperthyroidism or hypothyroidism \n\n Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study \n\n Patients with a history or current diagnosis of malignant tumor \n\n Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them", - "brief_summary": "A study to verify the superiority of YM060 (ramosetron) to placebo for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.", - "NCTID": "NCT01274000" - }, - { - "brief_title": "Sleepiness and the Risk of Falling", - "phase": "", - "drugs": "['zolpidem']", - "drugs_list": [ - "zolpidem" - ], - "diseases": "['Aging', 'Balance', 'Sleep']", - "diseases_list": [ - "Aging", - "Balance", - "Sleep" - ], - "enrollment": "24.0", - "inclusion_criteria": "inclusion criteria: \n\n Males and females \n\n Aged 18 to 35, or 60 to 85 \n\n Lived at Denver altitude or higher for at least one year \n\n Stable treated diseases: thyroid dysfunction (including hypothyroidism and hyperthyroidism), hypertension, hypercholesterolemia, urinary incontinence, prostate enlargement, gastroesophageal reflux disease, irritable bowel syndrome \n\n ", - "exclusion_criteria": ": \n\n Aged 36 to 59, under 18, or over 85 \n\n BMI less than 18.6 or greater than 30 kg/m2, women below 95 pounds regardless of BMI \n\n Sleep duration is less than 5 or more than 9 hours \n\n Sensitivity to sleeping medications \n\n Night work in the preceding 6 months \n\n Transmeridian travel (across more than 2 time zones) in the last 1 month \n\n Bone mineral density DXA T-score of less than -1.75 \n\n Orthostatic intolerance \n\n Prior history of falls in past year \n\n Prior history of injurious fall in past 5 years \n\n Hip fracture following a fall \n\n Difficulty rising from a sitting position without use of hands to push off \n\n Needing to walk slowly or with a wide base of support to maintain balance \n\n Hormone replacement therapy for less than 3 months \n\n Connective Tissue and Joint Disorders \n\n Neurologic Disorders \n\n Musculoskeletal Disorders \n\n Immune Disorders \n\n Sleep Disorders \n\n Chronobiologic Disorders \n\n Cardiovascular Disorders \n\n Respiratory Disorders \n\n Kidney and Urinary Tract Disorders \n\n Infectious Diseases \n\n Gastrointestinal Disorders \n\n Hematopoietic Disorders \n\n Neoplastic Diseases \n\n Endocrine and Metabolic Diseases \n\n Psychopathology \n\n Dementia \n\n Drug dependency", - "brief_summary": "The purpose of this project is to examine the impact of sleeping pills and waking up in the middle of the night on walking balance and cognitive function, to identify risk factors for falls in older adults. A significant percentage of falls, approximately 33 to 52 percent, occur during the nighttime and morning hours when people are normally sleeping; therefore, it is possible that sleep and sleeping medication related impairments in balance may contribute to this risk.", - "NCTID": "NCT00383357" - }, - { - "brief_title": "Grand Autohemo-Therapy With Oxygen-ozone on Patients With Hypertonia", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Hypertonia']", - "diseases_list": [ - "Hypertonia" - ], - "enrollment": "19.0", - "inclusion_criteria": "inclusion criteria: \n\n Resistant Hypertension > 140 / > 90mmHg \n\n Inclusion age : 45 + \n\n Regular monitoring of blood levels considered \n\n pre-medication to lower blood pressure for at least 3 weeks before the preliminary investigation consistent \n\n Men and Women \n\n ", - "exclusion_criteria": ": \n\n derailed diabetes \n\n renal impairment , renal creatinine clear <50 ml \n\n Non - austherapierte cancer / tumor patients \n\n Non - adjusted thyroid dysfunction \n\n BMI> 35 \n\n LVEF Stage II \n\n regurgitation > Stage I \n\n abdominal aneurysm \n\n infections \n\n acute febrile infections with temperature > 38.5 \u00b0 C \n\n COPD and asthma to stage III \n\n dyspnea NYHA > Stage III \n\n z.n. Stroke shorter than 12 weeks \n\n Acute liver failure \n\n Acute Apoplexy \n\n Severe poisoning \n\n drug addiction \n\n hyperthyroidism \n\n Hypotension \n\n hypocalcemia \n\n hypoglycemia \n\n ozone allergy \n\n pregnancy \n\n clotting problems ( hemophilia ) \n\n pre-existing condition with hemoglobin < 9mg/dl \n\n Fresh myocardial infarction \n\n Internal bleeding \n\n thrombocytopenia \n\n Acute alcohol \n\n Citrus allergy when using sodium citrate", - "brief_summary": "The objective of this clinical study is to evaluate the influence of the Great autohemotherapy with oxygen-ozone (hyperbaric ozone therapy ) to describe the cardiovascular system in patients with resistant hypertension. The primary endpoint is the change in mean blood pressure after 10 treatments .~In addition, data are collected on the immune system as well as for food and sleep quality.", - "NCTID": "NCT01902602" - }, - { - "brief_title": "Multiple Oral Administration of ASP7991 to Non-elderly Male Subjects", - "phase": "Phase 1", - "drugs": "['ASP7991', 'Placebo']", - "drugs_list": [ - "ASP7991", - "Placebo" - ], - "diseases": "['Healthy', 'Pharmacokinetics of ASP7991']", - "diseases_list": [ - "Healthy", - "Pharmacokinetics of ASP7991" - ], - "enrollment": "36.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy, as judged by the investigator/sub investigator based on the results of physical examination obtained before study drug administration \n\n Body weight: \u226550.0 kg, <80.0 kg \n\n BMI: \u226517.6, <26.4 \n\n Serum corrected calcium concentration: \u22659.0mg/dL, <10.4 mg/dL \n\n ", - "exclusion_criteria": ": \n\n Received any investigational drugs in other clinical or post-marketing studies within 120 days before screening \n\n Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before screening \n\n Received medication (including marketed drug) within 7 days before hospitalization, vitamin preparation including vitamin D and supplement including calcium or is scheduled to receive medication \n\n A deviation from normal criteria range of 12-lead ECG (QT evaluation) \n\n A deviation from the normal range in clinical laboratory tests \n\n Highly sensitive cardiac troponin T (at screening): \u22650.014 ng/mL \n\n History of drug allergies \n\n Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before admission \n\n Concurrent or previous hepatic disease (e.g., viral hepatitis, drug-induced liver injury) \n\n Concurrent or previous endocrine disorders (e.g., hyperthyroidism, aberration in growth hormone)", - "brief_summary": "This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after multiple oral administrations to non-elderly subjects.", - "NCTID": "NCT01872013" - }, - { - "brief_title": "Antithyroid Drug Treatment of Thyrotoxicosis in Young People", - "phase": "Phase 3", - "drugs": "['Block and Replace', 'Dose Titration', 'carbimazole', 'propylthiouracil', 'thyroxine']", - "drugs_list": [ - "Block and Replace", - "Dose Titration", - "carbimazole", - "propylthiouracil", - "thyroxine" - ], - "diseases": "['Paediatric Thyrotoxicosis']", - "diseases_list": [ - "Paediatric Thyrotoxicosis" - ], - "enrollment": "81.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients with thyrotoxicosis aged between 2 and 16 years at the time of diagnosis. Thyrotoxicosis will be diagnosed by the paediatrician on the basis of the clinical picture and the biochemistry (suppressed TSH with high thyroid hormone levels). \n\n Child has consented/assented or consent via parent/guardian has been gained prior to any study specific procedures \n\n ", - "exclusion_criteria": ": \n\n Known toxic adenoma / toxic hyperplasia (germline activating TSHR mutation). \n\n McCune Albright Syndrome. \n\n Previous episodes of Thyrotoxicosis.. \n\n Known allergic response to any of the study medication or ingredients as per SmPC. \n\n Previous participation in this study.", - "brief_summary": "The investigators aim to establish whether biochemical control during anti-thyroid drug therapy in young people with thyrotoxicosis varies depending upon whether a 'block and replace' or 'dose titration' regimen is used. The investigators will also assess remission rates and the frequency of side-effects in the two treatment groups.", - "NCTID": "NCT01436994" - }, - { - "brief_title": "Lacrimal Drainage System Obstruction Associated to Radioactive Iodine Therapy for Thyroid Carcinoma", - "phase": "", - "drugs": "['Radioiodine therapy']", - "drugs_list": [ - "Radioiodine therapy" - ], - "diseases": "['Lacrimal Apparatus Disease']", - "diseases_list": [ - "Lacrimal Apparatus Disease" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Thyroid carcinoma \n\n Previous thyroidectomy \n\n ", - "exclusion_criteria": ": \n\n Potential causes of dry eye (autoimmune diseases, contact lens wearers or drugs that alter tear production, such as antihistamines and psychotropic) \n\n Use of other anti-neoplastic, such as 5-fluorouracil and docetaxel, which can cause epiphora and OVL \n\n Lacrimal gland / ocular trauma \n\n Radiation therapy for other diseases or radiotherapy of head and neck \n\n Patients with diseases that alter the neural control of tear secretion, hormone therapies, pterygium, Graves' disease with or without ophthalmopathy, blepharitis and other conditions that may reduce tear production or result in rapid evaporation.", - "brief_summary": "The radioactive radioiodine therapy (Na131I) for the treatment of differentiated thyroid carcinoma is a procedure used for ablation of remaining thyroid tissue after thyroidectomy and metastases. Although serious complications are uncommon after treatment, there are well-documented adverse reactions secondary to the involvement of the salivary glands, such as dry mouth, pain in the parotid glands and dysphagia, even after administration of low doses of radioiodine. However, ocular complications of such treatment are scarcely reported in literature.~Among them the investigators can mention recurrent and chronic conjunctivitis, keratoconjunctivitis sicca and dry eye, affecting 23% of patients undergoing radioactive iodine therapy. Dysfunction of the lacrimal gland is described in recent studies, especially after high cumulative dose of the drug. Likewise, epiphora and nasolacrimal duct obstruction have been reported as complications associated with the use of radioiodine, although studies are not available to assess its true incidence through the systematic evaluation of patients.~It can be seen in routine practice that these patients would normally be referred for ophthalmological examination only if a complaint, what happens in the process of OVL already installed after the use of high doses of radioiodine. With the early evaluation of these patients, the investigators focused on detecting the process of ongoing obstruction in order to study interventions that prevent its final installation.", - "NCTID": "NCT01579344" - }, - { - "brief_title": "Long Term Follow-up of Bone Mineral Density in Hormone Treated Turner Syndrome", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Turner Syndrome']", - "diseases_list": [ - "Turner Syndrome" - ], - "enrollment": "54.0", - "inclusion_criteria": "inclusion criteria: \n\n Turner syndrome verified by karyotyping \n\n ", - "exclusion_criteria": ": \n\n untreated hypothyroidism or hyperthyroidism \n\n present or past malignant diseases \n\n clinical liver disease \n\n treatment with drugs known to interfere with bone metabolism (e.g. glucocorticoids)", - "brief_summary": "Turner Syndrome (TS) is associated with osteopenia and osteoporosis. Reduced bone mineral density (BMD) and increased risk of fractures are present in many younger and middle-aged women with TS. The objective is therefore to describe longitudinal changes in BMD in TS.~The study is an observational follow-up study. Examinations at baseline, after 5 and 10 years.~Bone mineral density is measured by dual energy x-ray absorptiometry (DEXA) and bone turnover by bone markers.~Main Outcome Measures: Bone mineral density (BMD; grams/ square centimetre) were measured at lumbar spine, hip and the non-dominant forearm.", - "NCTID": "NCT00625001" - }, - { - "brief_title": "Effects of Thyroid Hormone Withdrawal on Metabolic Parameters During Radioactive Iodine Therapy in Thyroid Cancer", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Hypothyroidism']", - "diseases_list": [ - "Hypothyroidism" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n radioiodine therapy after total thyroidectomy in differentiated thyroid cancer \n\n age over 18 \n\n ", - "exclusion_criteria": ": \n\n kidney failure, liver failure, heart failure \n\n infection \n\n inflammation \n\n autoimmune disease \n\n other chronic disease", - "brief_summary": "The incidence of differentiated thyroid cancer is increasing in Korea. A significant number of them experience severe hypothyroidism in preparation for radioactive iodine (RAI) therapy after total thyroidectomy.~Because the function of thyroid hormone is closely linked with lipid and glucose metabolism, overt hypothyroidism after thyroid hormone withdrawal during RAI therapy may induce the changes of metabolic parameters.~We investigate the effects of thyroid hormone withdrawal on metabolic and cardiovascular parameters during radioactive iodine therapy in differentiated thyroid cancer.", - "NCTID": "NCT01744769" - }, - { - "brief_title": "Omega-3 Fatty Acids and Muscle Protein Synthesis", - "phase": "", - "drugs": "['omega-3 fatty acids', 'corn oil']", - "drugs_list": [ - "omega-3 fatty acids", - "corn oil" - ], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "43.0", - "inclusion_criteria": "inclusion criteria: \n\n Body mass index (BMI) < 30 kg/m2; \n\n Age 18-45 yr; or \n\n Age 65-85 yr \n\n ", - "exclusion_criteria": ": \n\n Those taking medications known to affect substrate metabolism or medications that may confound the findings from our study (synthetic steroids, glucocorticoids etc.); \n\n Those with evidence of significant organ system dysfunction (e.g. diabetes mellitis, cirrhosis, hypo- or hyperthyroidism; hypertension); \n\n Body mass index > 30 kg/m2 \n\n Age <18 yr, 45-65 yr or > 85 yr \n\n Those performing >1.5h of exercise/wk", - "brief_summary": "The purpose of this study is to determine whether omega-3 fatty acid supplementation influences muscle protein synthesis rates in young and older adults.", - "NCTID": "NCT00794079" - }, - { - "brief_title": "Weight Loss Maintenance and Compensatory Mechanisms Activated With a Very-low Calorie Diet", - "phase": "", - "drugs": "['Multidisciplinary outpatient program', 'Inpatient lifestyle program']", - "drugs_list": [ - "Multidisciplinary outpatient program", - "Inpatient lifestyle program" - ], - "diseases": "['Obesity, Morbid']", - "diseases_list": [ - "Obesity", - "Morbid" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n volunteers from Central Norway \n\n if female: taking oral contraceptives or post-menopausal \n\n body mass index 30-45 kg/m2 \n\n stable weight (<2kg variation in the last 3 months) \n\n not currently dieting to lose weight \n\n ", - "exclusion_criteria": ": \n\n Pregnancy \n\n breast feeding \n\n drug or alcohol abuse within the last two years \n\n current medication known to affect appetite or induce weight loss \n\n enrollment in another obesity treatment program \n\n history of psychological disorders \n\n history of eating disorders \n\n history of diabetes type 1 or 2 \n\n gastrointestinal disorders (particular cholelithiasis) \n\n kidney -, liver -, lung- or cardiovascular disease \n\n malignancies", - "brief_summary": "Very-low calorie diets are relatively safe and effective in inducing significant weight loss, when used in selective individuals and under clinical supervision. However, weight loss maintenance in the long-term remains the main challenge, with many experiencing a significant weight regain. Several compensatory mechanisms are activated under weight reduction, both at the level of energy intake (such as increased appetite) and energy expenditure (such as reduced energy expenditure), and increase the risk of relapse.~The main aim of this study is to compare the effect of two multidisciplinary lifestyle interventions on weight loss maintenance at one year, after initial weight loss during 8 weeks very-low calorie diet. Participants will be allocated (non-randomly) to either an outpatient program in the obesity unit of the local hospital, or to an inpatient program consisting of a continuous care intervention, with three intermittent stays (each with three-week duration) in a rehabilitation center over a one year period. Moreover, the investigators aim to assess the impact of weight loss (achieved with a very low calorie diet) and weight loss maintenance on compensatory mechanisms activated during weight reduction.", - "NCTID": "NCT01834859" - }, - { - "brief_title": "LDL-Cholesterol Lowering Effect of KB2115 as Add on to Statin", - "phase": "Phase 2", - "drugs": "['KB2115']", - "drugs_list": [ - "KB2115" - ], - "diseases": "['Dyslipidemia']", - "diseases_list": [ - "Dyslipidemia" - ], - "enrollment": "180.0", - "inclusion_criteria": "inclusion criteria: \n\n Signed informed consent \n\n Males or females aged 18 to 75 years. Female patients must be non-fertile. To be considered as non-fertile, females must fulfil the following: \n\n Non-nursing and non-pregnant 12 months prior to enrolment \n\n Not of child bearing potential ie, either documented irreversible surgically sterile (bilateral oophorectomy or hysterectomy is acceptable, but not tubal ligation) or post-menopausal. Post-menopausal is defined as serum follicle-stimulating hormone (FSH) levels in the post-menopausal range combined with amenorrhea for more than 1 year in a woman above 50 years of age, or amenorrhea for more than 2 years below 50 years of age \n\n Patients with hypercholesterolemia treated with stable doses of the below listed lipid lowering medication for at least 3 months prior to randomization \n\n Atorvastatin not more than 20 mg/day or \n\n Simvastatin not more than 40 mg/day \n\n LDL-cholesterol > 3.0 mmol/L (Week -1) \n\n Subject able and willing to comply with all study requirements \n\n At randomization, diet as instructed by the investigator during the last 4 weeks prior to randomization and willingness to follow these instructions throughout the study \n\n ", - "exclusion_criteria": ": \n\n Cholesterol lowering agents other than the defined statins \n\n History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the investigator \n\n Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product as judged by the investigator \n\n Chronic (> 3 months) pain condition requiring daily medication with pain killers \n\n Glycosylated haemoglobin (HbA1c) > 7.0% \n\n Diabetes requiring medication other than metformin \n\n Clinically abnormal physical findings and laboratory values as judged by the investigator and abnormal resting ECG, eg, QTc interval > 450 msec \n\n Body Mass Index of \u2265 40 kg/m2 \n\n Resent history (< 3 month) of stroke or transient ischemic attacks \n\n History of seizure disorder, except febrile convulsions \n\n A current diagnosis of cancer, unless in remission \n\n Blood pressure (BP) of > 160/95 mm Hg \n\n History of cardiac arrhythmia, such as intermittent supraventricular tachyarrhythmia and atrial fibrillation \n\n Unstable angina pectoris, myocardial infarction or coronary bypass graft surgery or percutaneous coronary intervention < 6 month before randomization \n\n Congestive heart failure New York Heart Association Class > 2 \n\n Unstable or severe angina pectoris or peripheral artery disease \n\n Known thyroid disease or thyroid biomarkers (TSH, T3, free T3, T4, free T4) outside reference range for normal at enrolment and at baseline \n\n Positive urine pregnancy test in women at enrolment \n\n Use of thyroid replacement therapy and hormone replacement therapy (including contraceptive pills) for last 3 months before randomization", - "brief_summary": "Thyroid hormones are known to reduce cholesterol levels through regulation of a number of key enzymes involved in synthesis, degradation, and lipid transport. However, the currently marketed thyroid agonists are non-selective, and cannot be used for the treatment of hypercholesterolemia due to extrahepatic consequences of hyperthyroidism, especially on heart, bone, and muscle.~To take advantage of thyroid hormone effect on lipid metabolism for the treatment of hypercholesterolemia, it is necessary to develop a selective thyroid receptor agonist that can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the extrahepatic tissue. KB2115 is a thyroid agonist developed to be liver selective.~The purpose of the study is to assess the efficacy and safety of KB2115 as add on therapy to low and middle doses of statin following 12 weeks of exposure compared to placebo. The aim of the study is to assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115 at doses between 25 and 100 \u00b5g and to define a clinically relevant dose or dose range for future studies.", - "NCTID": "NCT00593047" - }, - { - "brief_title": "Thyroid Hormones Treatment in Asthma Exacerbation", - "phase": "", - "drugs": "['IV thyroxin', 'Placebo']", - "drugs_list": [ - "IV thyroxin", - "Placebo" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years of age or older \n\n Known Asthma \n\n The exacerbation is defined as moderate or severe. \n\n Not currently enrolled as an active participant in another clinical trial of a medical therapy or device. \n\n The patient or first degree family relative (in cases where the patient is intubated) has authorized his/her consent to participate in this trial. The patient will be asked to give his consent only after initial bronchodilator therapy \n\n ", - "exclusion_criteria": ": \n\n 60 years of age or older \n\n Known thyroid disorders \n\n Subject where thyrotoxicosis is suspected \n\n Known heart disease \n\n Heart rate > 140", - "brief_summary": "This study will explore whether supplementation with thyroid hormones in the set-up of asthma exacerbation could improve the clinical outcomes.~The study will include adults admitted to Rambam health care campus for moderate to severe Asthma exacerbation.~The study is a prospective, randomized, double-blind, placebo-controlled, clinical trial. Patients will be randomized on admission to receive treatment with intra-venous thyroxine (100mcg once on admission and additional 100mcg after 12 hours) or placebo. The study treatment will be given only after the initial bronchodilator therapy, oxygen and informed consent are given. The primary endpoint is the time to return of the peak expiratory flow (PEF) rate to normal values or personal base line.", - "NCTID": "NCT02086799" - }, - { - "brief_title": "Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment", - "phase": "Phase 2", - "drugs": "['Transcranial Direct Current Stimulation (TDCS)', 'Sham/no-stimulation']", - "drugs_list": [ - "Transcranial Direct Current Stimulation (TDCS)", - "Sham/no-stimulation" - ], - "diseases": "['Electric Stimulation Therapy', 'Obesity', 'Weight Loss', 'Eating']", - "diseases_list": [ - "Electric Stimulation Therapy", - "Obesity", - "Weight Loss", - "Eating" - ], - "enrollment": "148.0", - "inclusion_criteria": "inclusion criteria: \n\n BMI greater than or equal to 25 kg/m(2). \n\n Age 18-60 years. Women who are post-menopausal will be excluded from the study due to changes in their metabolism that could affect weight loss. We will set the cutoff at age 60 so that the age difference between the men and women is not too great for analysis purposes. Minors under the age of 18 will be excluded because the time requirements of the study are such that they would interfere with school schedules. \n\n Right-handedness (because the treatment will be given to the left dorsolateral prefrontal cortex and the evidence accumulated in this region was only in right-handed individuals) \n\n Weight stable (plus or minus 5 percent) for last 3 months as determined by volunteer report. \n\n ", - "exclusion_criteria": ": \n\n Weight > 300 lbs (136 kg), as this is the weight limit of the fMRI machine \n\n Use of medication affecting metabolism and appetite in the last three months \n\n Current pregnancy, pregnancy within the past 6 months or currently lactating \n\n History or clinical manifestations of acute or chronic disorders or conditions that may affect appetite or energy expenditure (such as, but not limited to type 1 or type 2 diabetes, Cushing s disease, thyroid disorders, coccidiomycoses) \n\n Gastrointestinal disease, including inflammatory bowel diseases (e.g. Chron s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active) which may alter metabolism \n\n Current, unstable medical conditions such as hepatitis, renal insufficiency, cancer requiring treatment in the last 5 years, or central nervous system disorders etc. as assessed by history and physical exam \n\n Evidence of alcohol abuse as defined by greater than or equal to 8 point score on the Alcohol consumption screening AUDIT questionnaire in adults \n\n Evidence of nicotine use or of drug use such as amphetamines, cocaine, heroin, or marijuana \n\n Postmenopausal women or symptoms of perimenopause (e.g. hot flashes, onset of irregular periods following age 40, elevation of FSH >20 IU following age 40 years) \n\n Any conditions contraindicated for MRI (e.g., pacemaker, metal in the cranial cavity, significant claustrophobia, holes in the skull made by trauma or surgery) \n\n Any condition not specifically mentioned above that, in the opinion of the investigator, may interfere with the study or prove unsafe for participation.", - "brief_summary": "This study will determine whether electrical stimulation of an area of the brain called the dorsolateral prefrontal cortex, which is important in determining the feeling of fullness after eating, affects how much food a person eats and weight loss over 4 weeks. It will also compare weight changes in people who attend weight loss counseling sessions and those who do not over this period of time.~Obese, non-diabetic people between 18 and 60 years of age who are in good health and who live in the Phoenix, AZ, metropolitan area are eligible for this study. Candidates must have a body mass index of 35 kg/m(2) or more and weigh less than 350 pounds.~Participants are admitted to the NIH inpatient unit in Phoenix for the first 9 days of the study for tests, which include meal tests to determine eating behaviors and caloric intake, blood and urine tests, glucose tolerance test, weight measurement, psychological assessments and DEXA scan to measure body fat. For 3 of the days, they will be asked to eat all of their food from automated vending machines. Some subjects receive transcranial direct current stimulation (TDCS). For this procedure, electrodes that conduct electricity are placed on the head and arm and the current is turned on for 40 minutes. Some tingling may be felt under the electrodes. Other subjects receive sham TDCS, with the current turned on only very briefly.~After the evaluations, subjects are discharged home from the NIH unit and instructed to eat 25 percent fewer calories than they consumed while on a weight maintenance diet the first 3 days of their inpatient stay. They maintain the lower calorie diet at home for 4 weeks. During this period they come to the NIH unit 3 days a week to receive either real or sham TDCS.", - "NCTID": "NCT00739362" - }, - { - "brief_title": "Effects of Mirtazapine on Appetite in Advanced Cancer Patients", - "phase": "Phase 2", - "drugs": "['Mirtazapine', 'Placebo']", - "drugs_list": [ - "Mirtazapine", - "Placebo" - ], - "diseases": "['Advanced Cancer', 'Anorexia', 'Weight Loss', 'Insomnia']", - "diseases_list": [ - "Advanced Cancer", - "Anorexia", - "Weight Loss", - "Insomnia" - ], - "enrollment": "98.0", - "inclusion_criteria": "inclusion criteria: \n\n Advanced cancer patients seen in outpatient clinics or inpatient units at MD Anderson Cancer Center, with presence of anorexia for at least one month, and accompanied by weight loss of > 5 % of pre-illness body weight in the last 6 months. Anorexia on the day of enrollment (day 0 +/-3) must be > 4/10 on ESAS. \n\n Patients > 18 years of age \n\n Karnofsky Performance score of > 40 at time of inclusion into study \n\n Ability to provide informed consent and comply with study procedures \n\n Ability and willingness to return to engage in telephone follow-up by research nurse on days 2 (+/- 3 days), 8 (+/- 3 days), 16 ( +/- 3 days), and 22 (+/- 3 days) and return to outpatient clinic for evaluation on days 15 (+/- 3 days), and 29 (+/- 3 days). \n\n Negative urine pregnancy test at time of inclusion into study for female patients of childbearing potential, within 24 hours of study enrollment. \n\n For patients receiving chemotherapy eligibility to be determined after discussion with primary oncologist \n\n Drowsiness of 11 at baseline indicating moderate or severe depression will be excluded from the study and will be referred for appropriate follow up by counselor and psychiatry evaluation. \n\n Patients on chronic use of benzodiazepines are excluded", - "brief_summary": "Primary objective: This is a preliminary study to determine if Mirtazapine in comparison to placebo will improve appetite in advanced cancer patients with anorexia and weight loss. An improvement of appetite is defined as a decrease of 2 in the appetite score from baseline on the Edmonton Symptom Assessment Scale (ESAS) at day 15 (+/-3 days).~Secondary objective-A: To determine if Mirtazapine in comparison to placebo will improve insomnia ( as measured by Pittsburgh Sleep Quality Index) on day 15 ( +/- 3 days), and day 29 ( +/- 3 days)~Secondary objective - B: To determine if Mirtazapine in comparison to placebo will improve other common symptoms such as pain, nausea and fatigue( as measured by ESAS), depression and anxiety ( as measured by Hospital Anxiety and Depression scale), and quality of life ( as measured by Functional Assessment of Anorexia/Cachexia Therapy ) in advanced cancer patients with anorexia/cachexia, on days 15 (+/-3 days), and 29 (+/-3 days)~Other Objectives:~To provide exploratory data on the effects of Mirtazapine on weight gain, and preservation/gain lean muscle mass ( anthropometric measurements and Bioelectric Impedance), on days 15 (+/-3 days), and 29 (+/-3 days).~To provide exploratory data on the effects of a Mirtazapine dose increase to 30 mg on decreased side effects of drug and increased appetite on day 29 (+/-3 days).", - "NCTID": "NCT00488072" - }, - { - "brief_title": "Treatment for Depressed, Obese Individuals at Risk for Cardiovascular Disease (CVD)", - "phase": "", - "drugs": "['Behavior Modification for Weight Loss', 'Alternative Approach to Weight Loss', 'Cognitive-Behavior Therapy for Depression', 'Depression Support and Education']", - "drugs_list": [ - "Behavior Modification for Weight Loss", - "Alternative Approach to Weight Loss", - "Cognitive-Behavior Therapy for Depression", - "Depression Support and Education" - ], - "diseases": "['Obesity', 'Major Depressive Disorder', 'Dysthymic Disorder', 'Cardiovascular Disease']", - "diseases_list": [ - "Obesity", - "Major Depressive Disorder", - "Dysthymic Disorder", - "Cardiovascular Disease" - ], - "enrollment": "76.0", - "inclusion_criteria": "inclusion criteria \n\n Female and male participants, with a BMI of 27 kg/m2 to 45 kg/m2 \n\n Age 18 - 70 years old \n\n Presence of current major depressive disorder or dysthymic disorder \n\n At least 2 CVD risk factors, as characterized by the metabolic syndrome, including: \n\n Elevated waist circumference (males 40 inches or 102 cm; females 35 inches of 88 cm) \n\n Fasting blood glucose 100 mg/dL \n\n Blood pressure 130/85 mm Hg \n\n Triglycerides 150 mg/dL \n\n Reduced HDL cholesterol (males 40 mg/dL; females 50 mg/dL) \n\n OR medications for these conditions \n\n Able to comply will all study procedures and schedule \n\n Able to speak and read English \n\n ", - "exclusion_criteria": " \n\n Cardiovascular event (e.g., myocardial infarction, stroke) within the past 12 months \n\n Use of tricyclic anti-depressants, monoamine oxidase inhibitors or paroxetine, mood stabilizers, or antipsychotic medications. (Note: participants who take SSRI/SNRI may be acceptable, provided they have been on a stable dose of these medications 3 months.) \n\n Use of weight-loss medications or any medications known to significantly affect weight (e.g., oral steroids) in past 3 months \n\n Weight loss of 5% or more in past 6 months \n\n Enrollment in weight reduction program in prior 3 months \n\n Treatment in individual psychotherapy for any psychiatric disorder in prior 3 months (Note: participants in couples or family counseling will be allowed.) \n\n Severe depression or severe impairment of functioning as judged by the assessor or PI \n\n Presence of active suicidal ideation \n\n Diabetes \n\n Alcohol/drug abuse/dependence \n\n Renal/hepatic disease \n\n Change in thyroid medications in last 3 months \n\n Pregnant/lactating, within 6-months post-partum \n\n Current diagnoses, or history within the last 5 years, of anorexia or bulimia \n\n Psychotic symptoms or hospitalization for a psychiatric disorder in previous 12 months \n\n Mood disorder NOS, substance-induced mood disorders, mood disorders due to a general medical condition \n\n History of bipolar disorder \n\n History of head trauma \n\n Any changes in smoking behavior in prior 3 months (or plans to change in the next 3 months) \n\n Plans for bariatric surgery \n\n Any other uncontrolled major medical problems \n\n Women who are pregnant", - "brief_summary": "To determine whether individuals who suffer from depression and obesity are able to lose weight and show improvements in mood and cardiovascular disease risk factors following 20 weeks of a combined treatment of cognitive-behavior therapy for depression and behavior modification for weight loss. Participants will be assigned to one of three treatments: 1) cognitive-behavior therapy for the treatment of depression combined with an alternative approach to weight loss, 2) a weight loss intervention combined with a depression support and education , or 3) cognitive-behavioral therapy for depression combined with a weight loss intervention.", - "NCTID": "NCT01692574" - }, - { - "brief_title": "A Phase II Trial of Valproic Acid in Patients With Advanced Thyroid Cancers of Follicular Cell Origin", - "phase": "Phase 2", - "drugs": "['Valproic Acid', 'Liothyronine Sodium']", - "drugs_list": [ - "Valproic Acid", - "Liothyronine Sodium" - ], - "diseases": "['Thyroid Neoplasm']", - "diseases_list": [ - "Thyroid Neoplasm" - ], - "enrollment": "13.0", - "inclusion_criteria": "inclusion criteria: \n\n Advanced/poorly differentiated thyroid cancers of follicular cell origin that have no uptake (less than 1%) on radioiodine scan or are unresponsive to radioiodine therapy. Unresponsiveness to radioiodine therapy is defined as a patient s thyroglobulin not falling to less than 2ng/ml within 6 months after previous radioiodine ablative treatment. \n\n Extensive (invasive) loco-regional tumor mass and/or metastatic spread, rendering patient inoperable. \n\n Thyroglobulin (Tg) levels greater than or equal to 100 ng/ml in the absence of Tg antibodies. Patients who are Tg-antibody (Tg-Ab) positive may be included despite a lower Tg level if they have detectable disease on cross sectional imaging. (The presence of Tg-Ab may lead to falsely low Tg levels and therefore render the Tg a less sensitive marker of disease. However, Tg-Ab has been shown to also act as a tumor marker, and will be used as an endpoint for the study in patients who are Tg-Ab positive.). \n\n Within 18 months of enrollment, patients must have had an radioactive iodine (RAI) scan, showing no or therapeutically insignificant RAI uptake (less than or equal to 1%). \n\n Initial therapy must have included total/near-total thyroidectomy and RAI ablation therapy. \n\n Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their malignancy in the month prior to treatment and must have recovered from all side effects of therapeutic and diagnostic interventions. \n\n Greater than or equal to 18 years of age. \n\n Must be able to understand and sign the Informed Consent Document. \n\n Clinical performance status of Eastern Oncology Cooperative Group (ECOG) less than or equal to 1. \n\n Life expectancy of greater than three months. \n\n Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (HCG) within 72 hours prior to study entry and must be willing to practice effective birth control to prevent pregnancy while receiving treatment and for three months after treatment is discontinued. All males of child fathering potential must also be willing to practice effective birth control. \n\n Laboratory results must be within the following parameters before entry: \n\n Absolute Neutrophil Count greater than 750 cells/mm(3) \n\n Hemoglobin greater than 8.0 gm/dl \n\n Platelet count greater than 75000/mm(3) \n\n Creatinine less tha 1.5 times upper limit of normal (ULN) \n\n Total protein greater than 6.4. \n\n Total bilirubin should be less than 1.5 times ULN. \n\n Aspartate aminotransferase (AST) serum glutamic oxaloacetic (SGOT), alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) less than 1.5 times ULN. \n\n Amylase less than 1.5 times ULN \n\n Ammonia less than 1.5 times ULN \n\n ", - "exclusion_criteria": ": \n\n Allergy to valproic acid. \n\n Current coexisting malignancy other than basal cell carcinoma. \n\n Women of child-bearing potential who are pregnant or breastfeeding. \n\n Valproic acid is a known teratogen, causing primary neural tube defects, facial abnormalities, and skeletal malformation; therefore pregnant women will be excluded. Additionally, patients that become pregnant while on study protocol will be discontinued immediately. \n\n Active systemic infections, coagulation disorders or other major medical illnesses. \n\n Patients taking tolbutamide, warfarin, zidovudine, benzodiazepines, clonazepam, diazepam. \n\n Seizure disorder.", - "brief_summary": "Background:~Patients who have advanced thyroid cancer have a low long-term survival rate. These types of thyroid cancer do not respond well to conventional surgery or radiation, or to specific thyroid cancer treatments such as radioactive iodine treatment and thyroid hormone for thyroid stimulating hormone (TSH) suppression.~Valproic acid has long been approved as an anticonvulsant to treat seizures in patients with epilepsy. It has also been used to treat bipolar disorder. Recent studies have shown that valproic acid has promising effects in thyroid cancer treatment because it may help destroy cancer cells and help conventional treatments be more effective. However, valproic acid is not approved for thyroid cancer and is therefore an investigational drug.~Objectives:~To determine whether valproic acid can inhibit tumor growth or induce tumor cell death.~To determine whether valproic acid can make tumor cells increase their uptake of radioiodine.~Eligibility:~- Individuals at least 18 years of age who have advanced-stage thyroid cancer that is either unresponsive to conventional treatments or fails to absorb radioiodine.~Design:~Eligible participants will continue on the standard thyroid hormone suppression therapy and begin receiving valproic acid for a total of 10 weeks. Participants will keep a study diary to record doses and side effects, and will have regular clinic visits to provide blood samples and receive additional valproic acid.~After 10 weeks, participants will have a Thyrogen scan to measure radioiodine uptake after valproic acid therapy. Tumor biopsies and blood samples will be taken at this time.~If there is increased radioiodine uptake on the scan, participants will have additional radioiodine therapy.~If there is no increased uptake on the scan, participants will continue on valproic acid for 7 more weeks. After 16 total weeks of treatment, additional blood samples and scans will be taken. Participants may continue to take valproic acid if the thyroid cancer appears to be responding to the treatment.~Follow-up visits will be scheduled at 3, 6, 9 (for patients continuing on valproic acid only), and 12 months.", - "NCTID": "NCT01182285" - }, - { - "brief_title": "Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Their Pregnancy", - "phase": "Phase 4", - "drugs": "['Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.']", - "drugs_list": [ - "Assessment of intellectual development", - "capacities of attention", - "learning process and degree of hyperactivity of the children between 6 and 9 years." - ], - "diseases": "['Hyperthyroid']", - "diseases_list": [ - "Hyperthyroid" - ], - "enrollment": "252.0", - "inclusion_criteria": "inclusion criteria: \n\n A-For the child born to hyperthyroid mother during pregnancy : \n\n oOld from 6 to 9 years included oAge of gestation between \u226537 and <41 weeks of amenorrhoea oBorn from a mono-foetale pregnancy oEuthyro\u00efd at the time of the entry in the study oProvided education for at the elementary school on a level adapted to its age \n\n B-For hyperthyroid mother during pregnancy : \n\n oHyperthyro\u00efd during pregnancy (transitory gestation hyperthyroid or disease of Basedow) oEuthyro\u00efd at the time of the entry in the study \n\n C-For the child born to euthyroid mother during pregnancy : \n\n oOld from 6 to 9 years included oAge of gestation between \u226537 and <41 weeks of amenorrhoea oBorn from a mono-foetale pregnancy oEuthyro\u00efd at the time of the entry in the study oProvided education for at the elementary school on a level adapted to its age \n\n D-For euthyroid mother during pregnancy : \n\n Euthyro\u00efd at the time of the entry in the study \n\n ", - "exclusion_criteria": ": \n\n A-For the child born to hyperthyroid mother during pregnancy : \n\n Discovered of a thyroid dysfonction at the time of the entry in the study \n\n B-For hyperthyroid mother during pregnancy: \n\n Discovered of a thyroid dysfonction at the time of the entry in the study \n\n C-For the child born to euthyroid mother during pregnancy: \n\n Discovered of a thyroid dysfonction at the time of the entry in the study \n\n D-For euthyroid mother during pregnancy: \n\n oDiscovered of a thyroid dysfonction at the time of the entry in the study oCarrying anti-TPO antibody at the time of the entry in the study", - "brief_summary": "MAIN OBJECTIVE :~To assess the consequences of a maternal hyperthyro\u00efd during pregnancy on intellectual development of the child from 6 to 9 years~SECONDARY OBJECTIVES :~To assess the consequences of a maternal hyperthyro\u00efd during pregnancy on the capacities of attention, learning process and the degree of hyperactivity of the child from 6 to 9 years.~To study if it exist differences of intellectual development, capacities of attention, learning process, and degree of hyperactivity in the child from 6 to 9 years, born to hyperthyroid mother during pregnancy, according to:~the etiology of the maternal hyperthyro\u00efd (transitory gestation hyperthyroid versus disease of Basedow),~the use or not of a anti-thyroid treatment,~the rate of TSH n\u00e9onatal (measured with the blotter by tracking with J3 at all the new born ones).", - "NCTID": "NCT01779817" - }, - { - "brief_title": "Re-differentiation of Radioiodine-Refractory BRAF V600E-mutant Papillary Thyroid Carcinoma With GSK2118436", - "phase": "", - "drugs": "['GSK2118436']", - "drugs_list": [ - "GSK2118436" - ], - "diseases": "['Papillary Thyroid Carcinoma']", - "diseases_list": [ - "Papillary Thyroid Carcinoma" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Histologically confirmed papillary thyroid carcinoma, including its variants, such as tall cell PTC or poorly differentiated thyroid carcinoma, that is metastatic or unresectable AND harbors a BRAF V600E mutation \n\n Evaluable disease, as defined by at least one lesion that can be accurately measured in at least one dimension on CT scan or ultrasound, if present in the neck \n\n Radioiodine-refractory disease \n\n Life expectancy > 6 months \n\n Able to swallow and retain oral medication \n\n Normal organ and marrow function \n\n ", - "exclusion_criteria": ": \n\n Pregnant or breastfeeding \n\n Previous treatment with a specific BRAF or MEK inhibitor \n\n Receiving any other study agents \n\n Known brain metastases \n\n History of allergic reactions attributed to compounds of similar chemical or biologic composition to GSK2118436, bovine TSH, mannitol or iodine \n\n Active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs \n\n History of known glucose-6-phosphate dehyrogenase (G6PD) deficiency \n\n Corrected QT interval >/= 480 msecs; history of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks; Class II, III, or IV heart failure, abnormal cardiac valve morphology; or history of known cardiac arrhythmias \n\n Taking herbal remedies \n\n Subjects with significant symptoms from their thyroid cancer, or have a large burden of rapidly progressive iodine-refractory PTC who are in need of other systemic therapy, as judged by their treating physician \n\n Uncontrolled current illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or psychiatric illness/social situations that would limit compliance with study requirements \n\n History of a different malignancy unless disease-free for at least 5 years and deemed to be at low risk for recurrence \n\n HIV-positive on combination antiretroviral therapy", - "brief_summary": "Radioactive iodine therapy is often part of the standard treatment for Papillary Thyroid Carcinoma (PTC) patients. However, in many patients, tumors develop a resistance or no longer respond to radioactive iodine therapy (iodine-refractory). Several lines of evidence suggest that blocking the BRAF gene may help to re-sensitize the tumors to radioactive iodine. BRAF is a protein that plays a central role in the growth and survival of cancer cells in some types of PTC. The investigational drug GSK2118436 may work by blocking the BRAF protein in cancer cells lines and tumors that have a mutated BRAF gene.~In this research study, the investigators are looking to see if GSK2118436 can re-sensitize iodine-refractory PTC to radioactive iodine therapy. The investigators are also looking at the safety of adding GSK2118436 to radioactive iodine therapy.", - "NCTID": "NCT01534897" - }, - { - "brief_title": "Functional Lipids and Appetite Regulation", - "phase": "", - "drugs": "['SALATRIM']", - "drugs_list": [ - "SALATRIM" - ], - "diseases": "['Obesity']", - "diseases_list": [ - "Obesity" - ], - "enrollment": "22.0", - "inclusion_criteria": "inclusion criteria: \n\n healthy males \n\n Normal weigh, e.i. BMI between 18,5-25 kg/m2 \n\n age 18-40 years \n\n ", - "exclusion_criteria": ": \n\n donation of blood 3 monhts prior or during the study \n\n gastrointestinal disorders, diabetes, hypertension, hyperlipidemia, chronic infectious disease \n\n smoking \n\n consumption of more than 21 alcoholic drinks/week \n\n elite athletes \n\n on mediation \n\n diet supplements", - "brief_summary": "To evaluate the short-term effects of structured lipids on appetite regulation.", - "NCTID": "NCT00259259" - }, - { - "brief_title": "Is the Routine Pressure Dressing After Thyroidectomy Necessary?", - "phase": "Phase 4", - "drugs": "['Normal dressing', 'Pressure dressing']", - "drugs_list": [ - "Normal dressing", - "Pressure dressing" - ], - "diseases": "['Thyroid Neoplasms', 'Thyroid Nodules', 'Graves Disease', 'Goiter']", - "diseases_list": [ - "Thyroid Neoplasms", - "Thyroid Nodules", - "Graves Disease", - "Goiter" - ], - "enrollment": "116.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients underwent thyroidectomy in Srinagarind hospital, Khonkaen University \n\n ", - "exclusion_criteria": ": \n\n Patients with cervical lymph nodes metastases requiring neck dissection \n\n Patients that tissue pathology shown anaplastic carcinoma \n\n Patients with clinical or laboratory indicators of coagulation disorders", - "brief_summary": "Thyroidectomy is an operation that is commonly performed. After an operation a pressure dressing by Hypafix is usually used due to the belief that it will help to reduce complications such as post-operative bleeding or haematoma. However, the practice is uncomfortable to patients and makes it hard to detect early haematomas.~We carried out a prospective randomised study to study the role of pressure dressing after thyroid surgery by evaluating the amount of fluids collected in the operative bed by ultrasonography compared with normal dressing.", - "NCTID": "NCT00400465" - }, - { - "brief_title": "Sub-Study of the PREVIEW Study Australia", - "phase": "", - "drugs": "['Low calorie diet administered from 0 to 2 months', 'High Protein / Low Glycaemic Index', 'Moderate Protein / High Glycaemic Index']", - "drugs_list": [ - "Low calorie diet administered from 0 to 2 months", - "High Protein / Low Glycaemic Index", - "Moderate Protein / High Glycaemic Index" - ], - "diseases": "['Pre-diabetes', 'Obesity']", - "diseases_list": [ - "Pre-diabetes", - "Obesity" - ], - "enrollment": "292.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 25 - 45 years and 55 - 70 years \n\n Overweight or obesity status BMI>25 kg/m2 \n\n Pre-diabetes. The criteria from WHO/IDF (International Diabetes Foundation) for assessing pre-diabetes will be used as the formal inclusion criteria, i.e. having: Impaired Fasting Glucose (IFG): Fasting venous plasma glucose concentration 5.6 - 6.9 mmol/l or Impaired Glucose Tolerance (IGT): Venous Plasma glucose concentration of 7.8 - 11.0 mmol/l at 2 h after oral administration of 75 g glucose (oral glucose tolerance test, OGTT), with fasting plasma glucose less than 7.0 mmol/l. Due to potential between-lab variation (local assessments), HbA1c is not used as an inclusion criteria in the screening. \n\n Informed consent required \n\n Ethnic group - No restrictions \n\n Smoking - Smoking is allowed, provided subjects have not recently (within 1 month) changed habits. However, smoking status is monitored throughout the study and used as a confounding variable. \n\n Motivation - Motivation and willingness to be randomized to any of the groups and to do his/hers best to follow the given protocol \n\n Other - Able to participate at CID's during normal working hours. \n\n ", - "exclusion_criteria": ": \n\n Based on interview and/or questionnaire, individuals with the following problems will be excluded: \n\n Medical conditions as known by the subjects: Diabetes mellitus (other than gestational diabetes mellitus); Significant cardiovascular disease including current angina; myocardial infarction or stroke within the past 6 months; heart failure; symptomatic peripheral vascular disease; Systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg whether on or off treatment for hypertension. If being treated, no change in drug treatment within last 3 months; Advanced chronic renal impairment; Significant liver disease e.g. cirrhosis (fatty liver disease allowed); Malignancy which is currently active or in remission for less than five years after last treatment (local basal and squamous cell skin cancer allowed); Active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsorption; Previous bariatric surgery; Chronic respiratory, neurological, musculoskeletal or other disorders where, in the judgement of the investigator, participants would have unacceptable risk or difficulty in complying with the protocol (e.g. physical activity program); A recent surgical procedure until after full convalescence (investigators judgement); Transmissible blood-borne diseases e.g. hepatitis B, HIV; Psychiatric illness (e.g. major depression, bipolar disorder). \n\n Medication: Use currently or within the previous 3 months of prescription medication that has the potential of affecting body weight or glucose metabolism such as glucocorticoids (but excluding inhaled and topical steroids; bronchodilators are allowed), psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). Low dose antidepressants are allowed if they, in the judgement of the investigator, do not affect weight or participation to the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the participant has been on a stable dose for at least 3 months. \n\n Personal/Other: Engagement in competitive sports; Self-reported weight change of >5 % (increase or decrease) within 2 months prior to screening; Special diets (e.g. vegan, Atkins) within 2 months prior to study start. A lacto-vegetarian diet is allowed; Severe food intolerance expected to interfere with the study; Regularly drinking > 21 alcoholic units/week (men), or > 14 alcoholic units/week (women); Use of drugs of abuse within the previous 12 months; Blood donation or transfusion within the past 1 month before baseline or CID's; Self-reported eating disorders; Pregnancy or lactation, including plans to become pregnant within the next 36 months; No access to either phone or Internet (this is necessary when being contacted by the instructor's during the maintenance phase); Adequate understanding of national language; Psychological or behavioral problems which, in the judgement of the investigator, would lead to difficulty in complying with the protocol. \n\n Laboratory screening: If all of the above criteria are satisfied, the participant is eligible for a glucose tolerance test (blood at 0 and 120 mins), and blood glucose concentrations are analyzed immediately (Haemocue). In addition full blood count, urea, and electrolytes may be analyzed as a further safety evaluation. \n\n ONLY IF the glucose tolerance test meets the entry criteria for the study, the remaining samples are sent to the local laboratory for a safety check, with the following ", - "brief_summary": "The aim of this study is to investigate possible enduring effects of a standard 2-month weight loss program on appetite regulation, bone homeostasis and muscle strength in younger and older adults, as well as the impact of differences in dietary composition during weight maintenance.", - "NCTID": "NCT02030249" - }, - { - "brief_title": "Web-Based Weight Loss & Weight Maintenance Intervention for Older Rural Women, Also Known as Women Weigh-in for Wellness", - "phase": "", - "drugs": "['Experimental: Web-based only (WO) weight intervention', 'Experimental: WO plus peer-led discussion board (WD)', 'Experimental: WO & professional email counseling (WE)']", - "drugs_list": [ - "Experimental: Web-based only (WO) weight intervention", - "Experimental: WO plus peer-led discussion board (WD)", - "Experimental: WO & professional email counseling (WE)" - ], - "diseases": "['Overweight and Obesity']", - "diseases_list": [ - "Overweight and Obesity" - ], - "enrollment": "301.0", - "inclusion_criteria": "inclusion criteria: \n\n women aged 40-69 \n\n overweight or Class I & II obese (BMI 28 to 39.9)or BMI 40 to 45 with physician clearance \n\n state a commitment to losing weight \n\n speak and read English \n\n able to communicate over the telephone \n\n able to use a computer with minimal assistance and complete electronic forms and surveys \n\n have access to and are able to access the Internet \n\n commitment to access the website as required by the research intervention including weekly self-reporting of calories and fat grams, weekly self-reporting of physical activity, pedometer steps, and body weight, and weekly (or more often) participation in other website components as determined by group to which randomized and phase of intervention \n\n have or are willing to obtain an email account \n\n have access to a DVD player \n\n able to walk without an assistive device \n\n answer 'no' to all questions on the Physical Activity Readiness Questionnaire (PAR-Q) or obtain clearance from their physician to become more active \n\n ", - "exclusion_criteria": ": \n\n diagnosed with Type 1 diabetes \n\n diagnosed with Type 2 diabetes and require insulin \n\n \u2265 10% weight loss in last six months \n\n enrolled in a weight loss management program \n\n enrolled in a formal program of cardiac rehabilitation or undergoing physical rehabilitation \n\n taking medications that affect weight loss or weight gain \n\n other physical or medical restrictions that would preclude following the minimum recommendations for moderate physical activity and healthy eating.", - "brief_summary": "This project will evaluate an Internet delivery strategy to address weight loss and maintenance among rural midlife and older women.", - "NCTID": "NCT01307644" - }, - { - "brief_title": "The Dose of Radioactive Iodine Needed to Ablate the Thyroid Remnant Left Behind After Thyroidectomy", - "phase": "Phase 3", - "drugs": "['Radioactive iodine']", - "drugs_list": [ - "Radioactive iodine" - ], - "diseases": "['Thyroid Neoplasms']", - "diseases_list": [ - "Thyroid Neoplasms" - ], - "enrollment": "160.0", - "inclusion_criteria": "inclusion criteria: \n\n Total or near total thyroidectomy performed for papillary or follicular thyroid cancer \n\n R0-1 resection, no macroscopic cancer left behind at surgery \n\n Physically and emotionally able to undergo radioiodine treatment \n\n A written informed consent \n\n ", - "exclusion_criteria": ": \n\n Pregnancy \n\n Physical or psychiatric illness that may deteriorate during the isolation period required by radioiodine therapy", - "brief_summary": "The thyroid cells take up iodine, and radioactive iodine is commonly used to irradiate residual thyroid tissue and thyroid cancer following surgical removal of the thyroid gland (thyroidectomy). A whole body radioactive iodine scanning is usually carried out after thyroidectomy to assess the amount of thyroid tissue left behind at surgery (that might still contain cancer), and to evaluate the presence of iodine avid lesions elsewhere in the body (that might be cancer metastases). A large dose of radioactive iodine is often given, still the optimal iodine dose to ablate the thyroid remnant after surgery is not known. In this study, two radioactive iodine doses are compared in the ablation of the thyroid remnant, a smaller (1110 MBq) dose and a larger (3700 MBq) dose. The study participants are randomly allocated using a 1:1 ratio to receive either the smaller or the larger radioactive iodine dose. These treatments are compared for safety, adverse effects, and the need for subsequent repeat treatments. The individual absorbed radiation doses are measured. The study hypothesis is that fewer repeat radioiodine treatments might be needed after the larger dose, but the larger dose might be associated with a higher frequency of adverse events.", - "NCTID": "NCT00115895" - }, - { - "brief_title": "Effects of THW and rhTSH in Glomerular Filtration Rate During RIT", - "phase": "", - "drugs": "['rhTSH Group']", - "drugs_list": [ - "rhTSH Group" - ], - "diseases": "['Other Impaired Renal Function Disorder']", - "diseases_list": [ - "Other Impaired Renal Function Disorder" - ], - "enrollment": "28.0", - "inclusion_criteria": "inclusion criteria: \n\n Normal Renal Function \n\n ", - "exclusion_criteria": ": \n\n Abnormal Renal Function \n\n Renal metastasis", - "brief_summary": "To observe the influence of thyroid hormone withdrawal and of recombinant human TSH during radioiodine therapy in renal function.", - "NCTID": "NCT01945125" - }, - { - "brief_title": "Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer", - "phase": "Phase 3", - "drugs": "['Lapatinib', 'Paclitaxel']", - "drugs_list": [ - "Lapatinib", - "Paclitaxel" - ], - "diseases": "['Neoplasms, Gastrointestinal Tract']", - "diseases_list": [ - "Neoplasms", - "Gastrointestinal Tract" - ], - "enrollment": "273.0", - "inclusion_criteria": "inclusion criteria: \n\n Specific Information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject eligibility is provided in the Investigator's Brochure (IB) Pilot Part \n\n Subjects eligible for enrollment in the Pilot Part of the study must meet all of the following criteria: \n\n Signed informed consent \n\n Male or female; \u2265 20 years (at the time of giving consent) \n\n Any histologically or cytologically confirmed gastric carcinoma independent of tumor ErbB2 status \n\n Subjects who have received one prior regimen for gastric carcinoma and developed disease progression or recurrence. The regimen must have contained 5-fluoropyrimidine and/or cisplatin \n\n Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by echocardiogram (ECHO). Multigated acquisition (MUGA) scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive (LVEF of \u226550% required if normal range of LVEF is not provided by institution) \n\n Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 \n\n Able to swallow and retain oral medication \n\n Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study \n\n Washout period from the prior last therapy as follows; Chemotherapy (except for agents below) 4 weeks (I.V) Chemotherapy (except for agents below) 2 weeks (P.O) Trastuzumab, Bevacizumab 4 weeks Mitomycin-C, nitrosourea 6 weeks Radiotherapy, Immunotherapy, Biologic therapy and Surgery (except for minor surgical procedure) 2 weeks \n\n Willing to complete all screening assessments as outlined in the protocol \n\n Adequate organ function as defined in Table 2 Baseline Laboratory Values \n\n Able to be hospitalized for PK analysis during cycle 1 \n\n Life expectancy of at least 12 weeks from the first dose of study treatment) \n\n Randomized Part \n\n Subjects eligible for enrollment in the Randomized Part of the study must meet all of the following criteria: \n\n Signed informed consent \n\n Male or female; \u2265 20 years (at the time of giving consent) \n\n Histologically or cytologically confirmed gastric carcinoma with documented amplification of ErbB2 by fluorescence in situ hybridization (FISH) in primary or metastatic tumor tissue \n\n Subjects who received one prior regimen for gastric carcinoma and defined as progression disease. The regimen must be containing 5-fluoropyrimidine and/or cisplatin \n\n Measurable lesion(s) according to RECIST (Response Evaluation Criteria in Solid Tumors) \n\n Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by echocardiogram. MUGA scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive (LVEF of \u226550% required if normal range of LVEF is not provided by institution) \n\n ECOG Performance Status of 0 to 1 \n\n Able to swallow and retain oral medication \n\n Archived (or Biopsy ) tumor tissue available for FISH testing [Wolff, 2007] in central laboratory \n\n Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study \n\n Washout period from the prior last therapy as follows; Chemotherapy (except for agents below) 4 weeks (IV) Chemotherapy (except for agents below) 2 weeks (P.O) Trastuzumab, Bevacizumab 4 weeks Mitomycin-C, nitrosourea 6 weeks Radiotherapy, Immunotherapy, Biologic therapy and Surgery (except for minor surgical procedure) 2 weeks \n\n Willing to complete all screening assessments as outlined in the protocol \n\n Adequate organ function as defined in Table 2 \n\n Gastrectomy status depending on the result in the Pilot Part \n\n Life expectancy of at least 12 weeks from the first dose of study treatment \n\n Table 2 Baseline Laboratory Values \n\n SYSTEM LABORATORY (VALUES) \n\n Hematologic: \n\n ANC (absolute neutrophil count) \n\n Hemoglobin: \n\n Platelets (\u2265 2.0 \u00d7 10^9/L) (\u2265 9 g/dL) (\u2265 100 \u00d7 10^9/L) Hepatic Albumin Serum bilirubin AST and ALT (\u2265 2.5 g/dL) (\u2264 1.25 x ULN) (\u2264 2.5 \u00d7 ULN without liver metastases) (\u2264 5 \u00d7 ULN if documented liver metastases) Renal Serum Creatinine \n\n Calculate Creatinine Clearance (see Section 11.3) (\u2264 2.0 mg/dL) \n\n - OR - (\u226530 mL/min) \n\n ", - "exclusion_criteria": ": \n\n Subjects meeting any of the following criteria must not be enrolled in the study: \n\n Pregnant or lactating female at anytime during the study \n\n Planned concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, hormonal therapy) while taking investigational treatment \n\n Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2) \n\n Peripheral neuropathy of Grade 2 or greater \n\n Malabsorption syndrome, disease significantly affecting gastrointestinal function. Subjects with ulcerative colitis and Crohn's disease are also excluded \n\n History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible \n\n Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety \n\n Life threatening infection \n\n Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent \n\n Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure \n\n Known history or clinical evidence of central nervous system (CNS) metastasis \n\n Concurrent treatment with prohibited medications, including herbal remedies and Chinese traditional medicines \n\n Concurrent treatment with an investigational agent within 28 days prior to the administration of paclitaxel and/or lapatinib \n\n Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to paclitaxel, including polyethoxylated castor oil, alcohol, or lapatinib or their excipients \n\n Anamnesis or diagnosis of pulmonary disorder, such as interstitial pneumonia, pulmonary fibrosis or serious hypoxia \n\n Gastrectomy surgery if Pilot Part of the study determines that partial gastrectomy (pylorus spared) or total/partial gastrectomy (pylorus removed) has a significant negative impact upon lapatinib PK and safety profile \n\n Known history of use of any EGFR agent (except Trastuzumab) \n\n Prior gastric cancer treatment which included a taxane.", - "brief_summary": "EGF104578 is two-part study (Pilot part/Randomized part).Pilot part is designed to find the optimal (best) doses of lapatinib and paclitaxel when given together,Randomized part is designed to evaluate the overall survival in patients receiving lapatinib and paclitaxel compared to patients receiving only paclitaxel.", - "NCTID": "NCT00486954" - }, - { - "brief_title": "Minimize Radioactive Iodine Ablation Of Remnant Thyroid in Differentiated Thyroid Cancer", - "phase": "Phase 2; Phase 3", - "drugs": "['I131', 'I123']", - "drugs_list": [ - "I131", - "I123" - ], - "diseases": "['Thyroid Neoplasms']", - "diseases_list": [ - "Thyroid Neoplasms" - ], - "enrollment": "556.0", - "inclusion_criteria": "inclusion criteria: \n\n patients with differentiated thyroid cancer \n\n recently underwent total thyroidectomy (within 6 months) \n\n pathological criteria \n\n T1bN0 : Tumor size 1-2cm with no microscopic extension with multifocality (within three foci) \n\n T3N0 : Tumor size <=2cm with microscopic extension (less than strap muscle) \n\n T1-3N1a : 3 or less micrometastatic lymph node \n\n ", - "exclusion_criteria": ": \n\n differentiated thyroid cancer with aggressive variant, poorly differentiated thyroid cancer, medullary thyroid cancer, anaplastic thyroid cancer \n\n gross extension (strap muscle or more) \n\n thyroid cancer with distant metastasis \n\n previous remote history of thyroid cancer surgery \n\n history of cervical external beam radiation therapy \n\n previous history of comorbid cancer within 5 years \n\n renal insufficiency (Ccr <30ml/min) \n\n women with pregnancy or breast feeding", - "brief_summary": "The researchers investigated the rate of biochemical remission in patients without radioactive iodine therapy compared to patients with low dose radioactive iodine treatment in differentiated thyroid cancer patients who underwent total thyroidectomy.", - "NCTID": "NCT02418247" - }, - { - "brief_title": "Effects of Oral Salt Supplementation on Physical Performance During a Half-ironman", - "phase": "", - "drugs": "['Salt administration', 'Placebo administration']", - "drugs_list": [ - "Salt administration", - "Placebo administration" - ], - "diseases": "['Hyponatremia']", - "diseases_list": [ - "Hyponatremia" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n -Triathletes with previous experience in half-ironman \n\n ", - "exclusion_criteria": ": \n\n -Potential participants (triathletes) with a previous history of muscle disorder, cardiac or kidney disease or those taking medicines or supplements during the two prior weeks were discarded.", - "brief_summary": "Background: Ultradistance athletes frequently consume salt supplements during competitions to compensate the loss of electrolytes by sweating. The aim of this study was to investigate the effectiveness of oral salt supplementation to improve exercise performance during a half-ironman triathlon. Methodology: Twenty-six experienced triathletes were matched for age, anthropometric data and training status and randomly placed into the salt group (113 mmol Na+ and 112 mmol Cl-) or the control group (cellulose). The experimental treatments were provided in unidentifiable capsules and were ingested before and during the race. Participants competed in a real half-ironman triathlon and race time was measured by means of chip timing. Pre and post-race, body mass, maximal force during a whole-body isometric strength test, maximal height during a countermovement jump, and blood samples were obtained. Sweat samples were obtained during the running section.", - "NCTID": "NCT02103491" - }, - { - "brief_title": "The Effect of Calcium on Postprandial Lipid Profile and Appetite", - "phase": "", - "drugs": "['high calcium intake']", - "drugs_list": [ - "high calcium intake" - ], - "diseases": "['Obesity']", - "diseases_list": [ - "Obesity" - ], - "enrollment": "18.0", - "inclusion_criteria": "inclusion criteria: \n\n healthy meals \n\n BMI 24-31 kg/m2 \n\n age between 18-50 years \n\n hemoglobin >8 mmol/L \n\n ", - "exclusion_criteria": ": \n\n donation of blood 6 months before and under the study \n\n milk allergy, diabetes, hypertension, hyperlipidemia, cronic infectious disease \n\n use of dietary supplements 3 months before and under the study \n\n smoking \n\n elite athletes \n\n use of medication", - "brief_summary": "The purpose of this study is to investigate the effect of calcium on postprandial lipid profile and appetite.", - "NCTID": "NCT00464035" - }, - { - "brief_title": "Radioactive Iodine in Treating Patients Who Have Undergone Surgery for Liver Cancer", - "phase": "Phase 3", - "drugs": "['adjuvant therapy', 'iodine I 131 ethiodized oil']", - "drugs_list": [ - "adjuvant therapy", - "iodine I 131 ethiodized oil" - ], - "diseases": "['Liver Cancer']", - "diseases_list": [ - "Liver Cancer" - ], - "enrollment": "300.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Histologically confirmed primary hepatocellular carcinoma (HCC) \n\n Completely resected disease with clear margins \n\n No residual disease by postoperative CT scan \n\n No metastatic disease \n\n PATIENT CHARACTERISTICS: \n\n Age: \n\n 17 and over \n\n Performance status: \n\n Karnofsky 60-100% \n\n Life expectancy: \n\n Not specified \n\n Hematopoietic: \n\n WBC greater than 1,500/mm^3 \n\n Platelet count greater than 50,000/mm^3 \n\n Hepatic: \n\n Bilirubin less than 2.92 mg/dL \n\n PT less than 4 seconds over control \n\n Renal: \n\n Creatinine less than 2.26 mg/dL \n\n Other: \n\n No contraindication to contrast or radioactive iodine \n\n No uncontrolled thyrotoxicosis \n\n No other prior or concurrent malignancy \n\n Not pregnant or nursing \n\n PRIOR CONCURRENT THERAPY: \n\n Biologic therapy \n\n Not specified \n\n Chemotherapy \n\n Not specified \n\n Endocrine therapy \n\n Not specified \n\n Radiotherapy \n\n Not specified \n\n Surgery \n\n See Disease Characteristics \n\n Recovered from prior surgery \n\n Other \n\n No other prior treatment for HCC", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Radioactive iodine may be effective in reducing the rate of recurrence of liver cancer after surgery to remove the tumor. It is not yet known if radioactive iodine is more effective than no further treatment after surgery.~PURPOSE: Randomized phase III trial to determine the effectiveness of radioactive iodine in treating patients who have undergone surgery for liver cancer.", - "NCTID": "NCT00027768" - }, - { - "brief_title": "Decitabine in Treating Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Iodine I 131", - "phase": "Phase 2", - "drugs": "['Decitabine', 'Iodine I 131', 'Recombinant thyrotropin alfa', 'Fludeoxyglucose F 18', 'Positron emission tomography']", - "drugs_list": [ - "Decitabine", - "Iodine I 131", - "Recombinant thyrotropin alfa", - "Fludeoxyglucose F 18", - "Positron emission tomography" - ], - "diseases": "['Recurrent Thyroid Cancer', 'Stage IVA Follicular Thyroid Cancer', 'Stage IVA Papillary Thyroid Cancer', 'Stage IVB Follicular Thyroid Cancer', 'Stage IVB Papillary Thyroid Cancer', 'Stage IVC Follicular Thyroid Cancer', 'Stage IVC Papillary Thyroid Cancer']", - "diseases_list": [ - "Recurrent Thyroid Cancer", - "Stage IVA Follicular Thyroid Cancer", - "Stage IVA Papillary Thyroid Cancer", - "Stage IVB Follicular Thyroid Cancer", - "Stage IVB Papillary Thyroid Cancer", - "Stage IVC Follicular Thyroid Cancer", - "Stage IVC Papillary Thyroid Cancer" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria: \n\n Histologically confirmed papillary thyroid or follicular thyroid carcinoma: \n\n Differentiated disease; \n\n Metastatic disease documented by ultrasound, computed tomography (CT) scan (without iodinated contrast), or MRI - All metastatic disease foci =< 10 mm in all dimensions \n\n Must have been treated with total or near-total thyroidectomy AND at least 1 course of iodine I 131 (131I)(>=29.9 mCi) OR demonstrated negative uptake on a postoperative low-dose131I scan \n\n Must have undergone whole body 131I scan 1-3 days after administration of =< 5.5 mCi of 131I demonstrating no visible iodine uptake within the lesions unless demonstrated negative uptake on a postoperative low-dose131I scan within the past 12 weeks: \n\n Must have 24-hour urine iodine excretion =< 500 mcg within 1 week of 131I scan \n\n Must be receiving thyroid hormone therapy AND have thyroid-stimulating hormone level =< 0.5 mU/L \n\n No known brain metastases \n\n Performance status: \n\n Eastern Cooperative Oncology Group (ECOG) 0-2 OR Karnofsky 60-100% \n\n Hematopoietic: \n\n Absolute neutrophil count >= 1,500/mm3; \n\n Platelet count >= 100,000/mm3; \n\n White Blood Count (WBC) >= 3,000/mm3 \n\n Hepatic: \n\n aspartate aminotransferase-alanine aminotransferase (AST and ALT) =< 2.5 times upper limit of normal; \n\n Bilirubin normal \n\n Renal: \n\n Creatinine not elevated OR \n\n Creatinine clearance >= 60 mL/min \n\n Cardiovascular: \n\n No symptomatic congestive heart failure; \n\n No unstable angina pectoris; \n\n No cardiac arrhythmia \n\n Not pregnant or nursing \n\n Negative pregnancy test \n\n Fertile patients must use effective contraception \n\n No prior allergic reaction attributed to compounds of similar chemical or biological composition to decitabine \n\n No concurrent uncontrolled illness \n\n No active or ongoing infection \n\n No psychiatric illness or social situation that would preclude study compliance \n\n No prior cytotoxic chemotherapy for thyroid cancer \n\n At least 6 months since prior external beam radiotherapy administered for locoregional disease in the thyroid bed or to the cervical or upper mediastinal lymph node regions (no more than 6,000 cGy) \n\n More than 6 months since other prior radiotherapy and recovered \n\n More than 6 months since prior therapeutic 131I > 10 mCi \n\n More than 18 months since prior cumulative 131I activity of at least 500 mCi \n\n More than 12 months since prior amiodarone (Unless 24-hour urinary iodine excretion is =< 500 mcg) \n\n No concurrent combination antiretroviral therapy for HIV-positive patients \n\n No other concurrent anticancer therapy \n\n No other concurrent investigational agents \n\n More than 6 months since prior intrathecal iodinated contrast (Unless 24-hour urinary iodine excretion is =< 500 mcg) \n\n More than 3 months since prior IV or oral iodinated contrast for radiographic studies (Unless 24-hour urinary iodine excretion is =< 500 mcg)", - "exclusion_criteria": "", - "brief_summary": "This phase II trial is studying how well decitabine works in treating patients with metastatic papillary thyroid cancer or follicular thyroid cancer that has stopped responding to radioactive iodine. Iodine I 131 (radioactive iodine) kills thyroid cancer cells. Metastatic thyroid cancer cells can lose the ability to be treated with radioactive iodine. Decitabine may help thyroid cancer cells regain the ability to respond to treatment with radioactive iodine.", - "NCTID": "NCT00085293" - }, - { - "brief_title": "Children s Growth and Behavior Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Obesity', 'Eating Behaviors', 'Healthy Volunteers']", - "diseases_list": [ - "Obesity", - "Eating Behaviors", - "Healthy Volunteers" - ], - "enrollment": "1500.0", - "inclusion_criteria": "inclusion criteria: \n\n Volunteers will qualify if they meet the following criteria. \n\n Age 8 17 years. \n\n Weight, height and BMI greater than or equal to 5th percentile for age and sex according to Centers for Disease Control and Prevention 2000 US standard. \n\n Cognitively capable of completing study procedures (FSIQ greater than or equal to 70). \n\n Good general health based on a normal history and physical examination (with the exception of overweight and minor, well-controlled illnesses). \n\n ", - "exclusion_criteria": ": \n\n Individuals will be excluded (and provided treatment referrals as needed) for the following reasons: \n\n History of major cardiovascular disease or any other serious obesity-related complication as assessed during history and physical exam. Individuals with untreated or major illnesses relating to the endocrine and/or cardiovascular systems are excluded because these illnesses will likely influence outcomes. Such obesity-related comorbidities include hypertension (defined by age- sex- and height- specific standards, and fasting hyperglycemia consistent with diabetes (fasting glucose > 126 mg/dL). \n\n Presence of other major illnesses: renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing syndrome, untreated hyper- or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication). Non-serious medical illnesses, such as seasonal allergies, will be reviewed on a case-by-case basis. \n\n Regular use of any medication known to affect body weight or eating behavior (e.g., many medications prescribed for attention deficit hyperactivity disorder, or ADHD). Medication use for non-serious conditions (e.g., acne) will be considered on a case-by-case basis. \n\n Current pregnancy or a history of pregnancy. A negative pregnancy test before starting the study will be required for postmenarcheal girls. \n\n Current and regular use of tobacco products and/or alcohol. \n\n A significant reduction in weight during the past three months, for any reason, exceeding 5% of body weight. \n\n A history of significant or recent brain injury that may considerably influence performance on neurocognitive measures (i.e., any history of loss of consciousness greater than or equal to 30 minutes associated with a head injury, any history of memory loss or hospitalization associated with a head injury, or greater than or equal to 2 concussions within last year). \n\n Presence of any significant, full-threshold psychiatric disorder based on DSM criteria such as schizophrenia, bipolar disorder, alcohol or substance abuse, anorexia or bulimia nervosa, or any disorder that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study. These individuals will not be permitted to enroll in the current study and will be referred for treatment. Individuals who present with other psychiatric disorders, including sub-threshold psychiatric disorders, will be permitted to enroll in the study. Sub-threshold psychiatric disorders include symptoms that do not meet diagnostic threshold based on the DSM criteria for mental disorders, but which are nevertheless significantly impairing or distressing. If, based on the opinion of the investigators, a participant requires treatment for his/her psychiatric symptoms,, the individual will be referred for treatment. Participants who develop any psychiatric disorder or significant psychiatric symptoms at any follow-up assessment during the study will not be excluded, but will be provided with treatment referrals. \n\n Any other condition in the child or parents/guardians that, in the opinion of the investigators, would impede compliance or possibly hinder completion of the study (e.g., significant Learning Disorder). \n\n Additional exclusions for (optional) stool sample collection include: \n\n Stool Sample only: \n\n Diagnosis or history of inflammatory bowel disease, including ulcerative colitis or Crohn's disease, celiac sprue, irritable bowel syndrome, or other inflammatory disorders of the intestine. \n\n Diarrhea within 1 week prior to sampling. \n\n Antibiotic use within 4 weeks prior to sampling. \n\n In addition, Experiments 1 and 2 have specific additional exclusions: \n\n Experiment 1 only: \n\n Regular use of medications that could influence autonomic or endocrine functioning, including alpha and beta blockers, oral contraceptives, or prescription pain medication. \n\n Scoring as highly active on the International Physical Activity Questionnaire (due to decreased cortisol reactivity). \n\n Experiment 2 only: \n\n Participants will be excluded if MRI and MEG is contraindicated (metal in body, braces, glasses required to correct vision, presence of non-organic [e.g., cochlear] implants or cerebral clips, permanent tattooed makeup or general tattoos in a dangerous location on the body or made with colors whose content in iron cannot be definitely ruled out. \n\n Youth will be excluded if they are left-handed. \n\n All participants will receive a written explanation of the purposes, procedures, and potential hazards of the study. Communication of this information and of the participant s assent as well as the consent of the parent or guardian will be documented in the medical record and copies of all signed documents given to each family. All participants will be informed of their right to withdraw from the study.", - "brief_summary": "Background:~- Studies show that many factors affect children s eating behavior and health. These include sleep, mood, thinking skills, and genetics. Studying children over time may identify children at higher risk for eating-related health concerns.~Objective:~- To understand how genes and environment influence eating behavior and health over time.~Eligibility:~- Children ages 8 17 in good general health.~Design:~Screening visit 1: Medical history, physical exam, body measurements, and questions.~14 days: Participants will wear a wrist monitor and answer smartphone prompts about eating and mood. They may give a stool sample.~Screening visit 2:~Body measurements.~Saliva, urine, and blood samples.~Heart tests.~Meals provided (after fasting overnight).~Questionnaires and interview.~Behavior, thinking, and exercise tests.~X-ray of left wrist and full body.~Some parents may have medical history, physical exam, and questions at screening visits. They may answer questions at the yearly visits.~Participants will have up to 6 yearly visits. They will give a urine sample and body measurements, and repeat the X-rays. They will have questions and behavior and thinking tasks. They may give stool samples. Visits will range from 3 to 8 hours.~Participants may choose to participate in other studies:~Stress and Hormones, 1 visit: While resting, participants will give saliva samples and have their heart monitored. Then they will do math. They will repeat the resting part, then do a computer task.~Brain Imaging, 2 visits: Twice, participants will perform tasks with a magnetic cone on their head then answer questions. Once, they will have an MRI, lying still in a scanner with a coil on their head.~Sleep, 2 visits: Participants will have food provided, answer questions and do tasks.~Participants will be compensated for the time and inconvenience involved with completing study procedures.~...", - "NCTID": "NCT02390765" - }, - { - "brief_title": "A Study Of Sunitinib Compared To Placebo For Patients With Advanced Pancreatic Islet Cell Tumors", - "phase": "Phase 3", - "drugs": "['sunitinib malate', 'Placebo']", - "drugs_list": [ - "sunitinib malate", - "Placebo" - ], - "diseases": "['Carcinoma, Islet Cell', 'Carcinoma, Pancreas']", - "diseases_list": [ - "Carcinoma", - "Islet Cell", - "Carcinoma", - "Pancreas" - ], - "enrollment": "171.0", - "inclusion_criteria": "inclusion criteria: \n\n Well-differentiated advanced/metastatic pancreatic islet cell tumor \n\n Tumor has shown progression within the past year. \n\n ", - "exclusion_criteria": ": \n\n Current treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational anticancer agent other than somatostatin analogues \n\n Prior treatment with any tyrosine kinase inhibitors or anti-VEGF[Vascular endothelial growth factor] angiogenic inhibitors. \n\n Prior treatment with non-VEGF-targeted angiogenic inhibitors is permitted", - "brief_summary": "This study randomized patients with advanced pancreatic islet cell tumors to receive either sunitinib or placebo. Patients who were randomized to sunitinib received 37.5 mg of sunitinib daily, those randomized to placebo received a tablet that looked similar but had no active drug. Neither the patient or the doctor knew whether the patient was receiving sunitinib or placebo. Patients were followed to determine the status and size of their tumors, survival, quality of life and safety of the drug.~The study was designed to detect a 50% improvement in median PFS[Progression Free Survival] with 90% power and was to enroll 340 subjects. An interim analysis was planned when 130 events had occurred, and the final analysis was to be conducted when 260 events had occurred.~Study A6181111 was stopped early during the enrollment period because of a clear and clinically meaningful improvement in efficacy for the sunitinib treatment arm as recommended by the DMC [Data Monitoring Committee]. The actual number of subjects enrolled was 171 and the actual number of PFS events recorded was 81 PFS events. The decision to terminate the study was not based on safety concerns related to sunitinib administration.", - "NCTID": "NCT00428597" - }, - { - "brief_title": "Framingham State Food Study", - "phase": "", - "drugs": "['Feeding study']", - "drugs_list": [ - "Feeding study" - ], - "diseases": "['Obesity', 'Diabetes', 'Cardiovascular Disease']", - "diseases_list": [ - "Obesity", - "Diabetes", - "Cardiovascular Disease" - ], - "enrollment": "234.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged 18 to 65 years \n\n BMI \u2265 25 kg/m2 \n\n Weight \u2264 425 lbs \n\n Medical clearance from a primary care provider \n\n Plans to matriculate at Framingham State University (campus-based participants: students), work on campus (campus-based participants: faculty and staff), or live in the greater Framingham area (community-based participants) throughout the academic year of enrollment in the study \n\n Academic and social clearance from the FSU Office of Enrollment and Student Development (student participants) or willingness to comply with Criminal Offender Record Information (CORI) check and Sex Offender Registry Information (SORI) check (community-based subjects) \n\n Willingness to eat and drink only the foods and beverages on the study menus during participation, with no food allergies or aversions \n\n Willingness to eat in the dining hall \n\n Willingness to abstain from consuming alcohol during participation \n\n ", - "exclusion_criteria": ": \n\n Change in body weight exceeding \u00b110% during prior year \n\n Recent adherence to a special diet \n\n Recent adherence to a vigorous physical activity regimen (e.g., participation in a varsity sport) \n\n Chronic use of any medication or dietary supplement that could affect study outcomes \n\n Current smoking (1 cigarette in the last week) \n\n Heavy baseline alcohol consumption (> 10 drinks/week) or history of binge drinking (\u2265 5 drinks in 1 day, anytime in past 6 months) \n\n Physician diagnosis of a major medical/psychiatric illness or eating disorder \n\n Abnormal HgA1c, TSH, BUN, creatinine; hematocrit < 30; ALT > 200% of normal upper limit \n\n Plans for a vacation during the study that would preclude adherence to prescribed diet \n\n Additional exclusions for female participants: Irregular menstrual cycles; any change in birth control medication during the 3 months prior to enrollment; pregnancy or lactation during the 12 months prior to enrollment", - "brief_summary": "This study will evaluate the effects of dietary composition on energy expenditure and chronic disease risk factors, while also exploring physiological mechanisms underlying these effects.", - "NCTID": "NCT02068885" - }, - { - "brief_title": "Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer", - "phase": "Phase 2", - "drugs": "['Iodine I-131', 'Placebo Administration', 'Selumetinib']", - "drugs_list": [ - "Iodine I-131", - "Placebo Administration", - "Selumetinib" - ], - "diseases": "['Metastatic Thyroid Gland Carcinoma', 'Poorly Differentiated Thyroid Gland Carcinoma', 'Recurrent Thyroid Gland Carcinoma', 'Stage IV Thyroid Gland Follicular Carcinoma AJCC v7', 'Stage IV Thyroid Gland Papillary Carcinoma AJCC v7', 'Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7', 'Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7', 'Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7', 'Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7', 'Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7', 'Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7']", - "diseases_list": [ - "Metastatic Thyroid Gland Carcinoma", - "Poorly Differentiated Thyroid Gland Carcinoma", - "Recurrent Thyroid Gland Carcinoma", - "Stage IV Thyroid Gland Follicular Carcinoma AJCC v7", - "Stage IV Thyroid Gland Papillary Carcinoma AJCC v7", - "Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7", - "Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7", - "Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7", - "Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7", - "Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7", - "Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of recurrent and/or metastatic thyroid cancer \n\n Histological or cytological confirmation of thyroid carcinoma of follicular origin (including papillary, follicular, or poorly differentiated subtypes and their respective variants); NOTE: medullary and anaplastic thyroid cancers are excluded; Hurthle cell carcinomas are excluded (defined as having an invasive tumor composed of > 75% oncocytic [Hurthle] cells lacking the nuclear features of papillary carcinoma, tumor necrosis, and marked mitotic activity); patients with oncocytic (Hurthle cell) variants of papillary thyroid carcinoma (defined as a tumor composed of a majority of oncocytic [Hurthle] cells having the nuclear features of papillary carcinoma) are eligible to participate \n\n RAI-avid lesion on a radioiodine scan (a diagnostic, post-therapy, or post-ablation scans) performed =< 24 months prior to registration, which suggests that therapy with 131I is justifiable in the judgment of the investigator \n\n Clinically or radiographically evident structural disease; patients with measurable disease and those with only non-measurable (non-target) structural disease (according to modified Response Evaluation Criteria in Solid Tumors [RECIST] version [v] 1.1 criteria) are eligible; \n\n NOTE 1: Modification of the RECIST v1.1 measurable disease criteria includes a change in the definition of what is considered a measurable malignant lymph node; a malignant lymph node is considered measurable if any of the following apply: \n\n It is noted to be RAI-avid on radioactive iodine imaging (diagnostic or post-therapy whole body scans acceptable) and it measures >= 1 cm in the long axis, \n\n It is pathologically proven to be involved with thyroid cancer (by cytology or pathology) and it measures >= 1 cm in the long axis, or \n\n Its short axis is >= 1.5 cm when assessed by computed tomography (CT) scan NOTE 2: Patients only with biochemical evidence of disease without structural evidence of cancer are not eligible for this study \n\n For patients with non-measurable, structural disease the following must apply: \n\n Undetectable thyroglobulin antibody AND \n\n A serum thyroglobulin of 10 ng/ml or greater in the context of suppressed thyroid-stimulating hormone (TSH) (TSH =< 0.4 mcU/ml) =< 28 days prior to study registration; use of any thyroglobulin assay is allowed, though all serum thyroglobulin measurements for study purposes must be conducted with the same thyroglobulin assay \n\n Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 \n\n Able to swallow and retain orally-administered medication with no clinically significant gastrointestinal abnormalities that may alter absorption \n\n Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 28 days prior to randomization) \n\n Platelet count >= 100,000/mm^3 (obtained =< 28 days prior to randomization) \n\n Hemoglobin > 9.0 g/dL (obtained =< 28 days prior to randomization) \n\n Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 28 days prior to randomization) \n\n Aspartate transaminase (AST) =< 2.5 x ULN (or =< 5 x ULN in presence of liver metastases) (obtained =< 28 days prior to randomization) \n\n Creatinine =< 1.5 mg/dL OR calculated creatinine clearance of >= 50 ml/min by either the Cockcroft-Gault formula or 24-hours urine collection analysis (obtained =< 28 days prior to randomization) \n\n Negative pregnancy test performed =< 7 days prior to registration for women of childbearing potential only \n\n Provide informed written consent \n\n Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study) \n\n Note: during the Active Monitoring Phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up \n\n Willing to provide mandatory archival tumor tissue (block or minimum of 30 unstained slides from a primary or recurrent/metastatic thyroid cancer) for correlative research purposes; NOTE: patients with less archival tumor tissue available may still be eligible for the study after discussion with Academic and Community Cancer Research United (ACCRU); receipt of archival tumor tissue is not required for study registration and initiation of therapy \n\n Willing to provide mandatory blood samples for correlative research purposes \n\n ", - "exclusion_criteria": ": \n\n 131I therapy =< 6 months prior to registration; Note: 131I administered solely for diagnostic purposes is not considered 131I therapy \n\n External beam radiation therapy =< 28 days prior to registration; note: previous treatment with radiation is allowed if the investigator judges it will not compromise patient safety on the study \n\n Having been treated with a total cumulative (lifetime) 131I therapeutic activity > 800 mCi (excluding 131I activity administered for diagnostic scans) \n\n Treatment with chemotherapy or targeted therapy (e.g. tyrosine kinase inhibitor) =< 28 days prior to registration \n\n Prior exposure to mitogen-activated protein kinase kinase (MEK), RAS, or RAF inhibitors (note: previous exposure to sorafenib is allowed) OR history of hypersensitivity to selumetinib, thyrotropin alpha (Thyrogen), or any excipient agents \n\n Unresolved toxicity > Common Terminology Criteria for Adverse Events (CTCAE) grade 2 from previous anti-cancer therapy, except for alopecia \n\n Cardiac conditions as follows: \n\n Uncontrolled hypertension (blood pressure [BP] >=150/95 mmHg despite medical therapy) \n\n Left ventricular ejection fraction < 55% measured by echocardiography \n\n Atrial fibrillation with a ventricular rate > 100 beats per minute (bpm) on electrocardiogram (ECG) at rest \n\n Symptomatic heart failure (New York Heart Association [NYHA] grade II-IV) \n\n Prior or current cardiomyopathy \n\n Severe valvular heart disease \n\n Uncontrolled angina (Canadian Cardiovascular Society grade II-IV despite medical therapy) \n\n Acute coronary syndrome =< 6 months prior to registration \n\n Ophthalmological conditions as follows: \n\n Intra-ocular pressure > 21 mmHg, or uncontrolled glaucoma (irrespective of intra-ocular pressure) \n\n Current or past history of central serous retinopathy or retinal vein occlusion \n\n Symptomatic or untreated leptomeningeal disease, brain metastasis, or spinal cord compression \n\n Unable to follow a low iodine diet or requiring medication with high content in iodide (e.g., amiodarone) \n\n Received iodinated intravenous contrast within =< 2 months of registration; avoidance of iodinated oral contrast is also preferred but not strictly required for study enrollment; NOTE: those who have had iodinated intravenous contrast within this time frame may still be eligible if a urinary iodine analysis reveals that excess iodine has been cleared (defined as urinary iodine documented to be < 300 mcg/day by either a spot urinary iodine or 24-hour urinary iodine measurement) \n\n Any of the following: \n\n Pregnant women \n\n Nursing women \n\n Men or women of childbearing potential who are unwilling to employ adequate contraception \n\n Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens \n\n Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy; NOTE: patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial \n\n Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, hepatitis B infection, hepatitis C infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements \n\n Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. (NOTE: Performance of investigational 124I PET/CT scans is allowed prior to and during conduct of this study) \n\n Other active malignancy =< 2 years prior to registration that will interfere with conduct of this trial; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history of prior malignancy, patients must not be receiving other specific treatment (chemotherapy, hormonal therapy, radiation) for their cancer \n\n Not willing to discontinue use of supplemental vitamin E", - "brief_summary": "This phase II trial studies how well iodine I-131 works with or without selumetinib in treating patients with thyroid cancer that has returned (recurrent) or has spread from where it started to other places in the body (metastatic). Many thyroid cancers absorb iodine. Due to this, doctors often give radioactive iodine (iodine I-131) alone to treat thyroid cancer as part of standard practice. It is thought that the more thyroid tumors are able to absorb radioactive iodine, the more likely it is that the radioactive iodine will cause those tumors to shrink. Selumetinib may help radioactive iodine work better in patients whose tumors still absorb radioactive iodine. It is not yet known whether iodine I-131 is more effective with or without selumetinib in treating thyroid cancer.", - "NCTID": "NCT02393690" - }, - { - "brief_title": "Decision Making on Radioactive Iodine Treatment for Papillary Thyroid Cancer", - "phase": "Phase 2; Phase 3", - "drugs": "['Decision aid exposure']", - "drugs_list": [ - "Decision aid exposure" - ], - "diseases": "['Thyroid Cancer']", - "diseases_list": [ - "Thyroid Cancer" - ], - "enrollment": "74.0", - "inclusion_criteria": "inclusion criteria for patient participants: \n\n Individuals with papillary thyroid carcinoma who have had complete resection of their thyroid at surgery (total or near-total thyroidectomy, or hemi- [subtotal] with completion thyroidectomy)on or after September 1, 2009 \n\n Age at time of first thyroid cancer surgery must be at least 18 years or older \n\n The papillary thyroid cancer TNM pathologic stage must be pT1 or pT2, N0 (or Nx), M0 (or Mx) (TNM stage, AJCC VI) (ie. primary tumor size 1-4 cm, no known positive lymph nodes at the time of primary surgery, no extension of the tumor outside the thyroid, no venous or lymphatic invasion, and no known distant metastases at primary surgery, with no tall cell features, as per surgical pathology report) \n\n Must be able to communicate in spoken and written English \n\n Must be able to use a computer \n\n Must be able to provide informed consent on one's own (without any need for translation) \n\n ", - "exclusion_criteria": " for patient participants: \n\n Participants not meeting inclusion criteria \n\n Concurrent diagnosis of medullary or anaplastic or poorly differentiated thyroid cancer or thyroid lymphoma \n\n Prior radioactive treatment for thyroid cancer \n\n Individuals who have been taken off their thyroid hormone for testing or treatment, will not be eligible for the study while off this medication. \n\n Individuals who are unwilling for investigators to confirm their pathologic stage of disease through review of pathology report(s) will be ineligible for the study \n\n inclusion criteria for the physician feedback component of this study: \n\n - Physicians and surgeons caring for thyroid cancer patients, in active practice at University Health Network in Toronto, Ontario, Canada.", - "brief_summary": "In this study, we will test, using a randomized controlled trial design, whether the use of a computer-based decision aid (DA) may improve general knowledge and reduce personal decisional conflict in patients with early stage papillary thyroid cancer (PTC), when compared to usual care. Patients with early stage PTC will be required to have surgical pathologic criteria for which adjuvant RAI treatment may be considered optional.", - "NCTID": "NCT01083550" - }, - { - "brief_title": "Dental Safety Profile of High-Dose Radioiodine Therapy", - "phase": "", - "drugs": "['Radioiodine']", - "drugs_list": [ - "Radioiodine" - ], - "diseases": "['Thyroid Cancer']", - "diseases_list": [ - "Thyroid Cancer" - ], - "enrollment": "202.0", - "inclusion_criteria": "inclusion criteria: \n\n histologically confirmed differentiated thyroid cancer \n\n status after total thyroidectomy \n\n status after subsequent high-dose radioiodine treatment \n\n regular follow-up by a board-certified dentist \n\n a minimum follow-up of 1 year after radioiodine therapy. \n\n ", - "exclusion_criteria": ": \n\n anaplastic thyroid cancer", - "brief_summary": "We aim to assess the incidence of oral and dental adverse events after high-dose radioiodine therapy for differentiated thyroid cancer.", - "NCTID": "NCT00439478" - }, - { - "brief_title": "Cardiovascular System in Obesity: Effect of Treatment", - "phase": "Phase 2", - "drugs": "['fenfluramine', 'phentermine']", - "drugs_list": [ - "fenfluramine", - "phentermine" - ], - "diseases": "['Heart Diseases', 'Obesity', 'Vascular Diseases']", - "diseases_list": [ - "Heart Diseases", - "Obesity", - "Vascular Diseases" - ], - "enrollment": "", - "inclusion_criteria": "Men and women, ages 18 to 60. Body weight was 130 to 180 percent of ideal body weight.", - "exclusion_criteria": "", - "brief_summary": "To determine the long-term efficacy of the combination therapy of phentermine and fenfluramine in conjunction with diet, exercise, and behavior modification in the treatment of simple, moderate obesity.", - "NCTID": "NCT00000506" - }, - { - "brief_title": "Take HEED (Healthy Eating and Exercise Decisions)", - "phase": "", - "drugs": "['culturally adapted behavior change']", - "drugs_list": [ - "culturally adapted behavior change" - ], - "diseases": "['Obesity']", - "diseases_list": [ - "Obesity" - ], - "enrollment": "223.0", - "inclusion_criteria": "inclusion criteria: \n\n BMI greater than 30 \n\n African American \n\n 40-46 years old \n\n ", - "exclusion_criteria": ": \n\n - bariatric surgery within the previous 5 years", - "brief_summary": "This is a randomized intervention that examines the effect of culturally adapted weight loss program in African American (AA) females age 40-65. Evidence suggests that AA women are more successful with weight loss programs that are culturally tailored (Karanja, et al, 2002). Take HEED is a combination of 2 interventions, Therapeutic Lifestyle Changes Diet (TLC) from ATP-III and the CHANGE exercise program, which have shown success independently in previous clinical trials with AAs.", - "NCTID": "NCT00306709" - }, - { - "brief_title": "Effects of Images Following Long-term Aerobic Exercise on Brain Activation", - "phase": "", - "drugs": "['Aerobic Exercise']", - "drugs_list": [ - "Aerobic Exercise" - ], - "diseases": "['Obesity']", - "diseases_list": [ - "Obesity" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or Female \n\n 18-65 years old (inclusive) \n\n Weigh less than 350 lbs \n\n Body mass index (BMI) between 25-43 kg/m2 \n\n Willing to fast for 10 hours prior to examination \n\n Right handed \n\n ", - "exclusion_criteria": ": \n\n Diagnosis (by self report) of diabetes \n\n Diagnosis (by self report) of neurological condition \n\n Current or past alcohol or drug abuse problem \n\n Smoking \n\n Have internal metal medical devices including cardiac pacemakers, aortic or cerebral aneurysm clips, artificial heart valves, ferromagnetic implants, shrapnel, wire sutures, joint replacements, bone or joint pins/rods/screws/clips, metal plates, metal fragments in your eye, or non-removable metal jewelry such as rings \n\n Unable or unwilling to complete the imaging procedures for the duration of the MRI scan due to claustrophobia or other reason", - "brief_summary": "The primary purpose of this study is to quantify activation of regions of the brain associated with appetite and reward after viewing high sugar and high fat (HS/HF) images compared to control images following long-term aerobic exercise.~After long-term aerobic exercise compared to a no-exercise control group, viewing HS/HF food images vs. control images will result in higher activation of regions of the brain associate with appetite (hypothalamus).~After long-term aerobic exercise compared to a no-exercise control group consumption of a sucrose solution compared to an artificially sweetened solution and a tasteless solution, viewing HS/HF food images vs. control images will result in lower activation of regions of the brain associated with reward [amygdala, anterior cingulate cortex (ACC), Orbitalfrontal Cortex (OFC), and ventral tegmental area (VTA), striatum, insula] in overweight and obese men and women.~Exploratory Aims As exploratory aims, investigators will test a preliminary brain connectivity analysis.", - "NCTID": "NCT02162524" - } - ], - "1": [ - { - "brief_title": "Remission Induction and Sustenance in Graves' Disease 2", - "phase": "", - "drugs": "['Stop medication']", - "drugs_list": [ - "Stop medication" - ], - "diseases": "['Graves Disease', 'Hyperthyroidism']", - "diseases_list": [ - "Graves Disease", - "Hyperthyroidism" - ], - "enrollment": "139.0", - "inclusion_criteria": "inclusion criteria: \n\n Graves hyperthyroidism in remission after ATD \n\n ", - "exclusion_criteria": ": \n\n Age < 18, severe concomitant disease", - "brief_summary": "ATD therapy for Graves' disease is one of the commonly used options for therapy of the hyperthyroidism. The investigators study how to optimally keep patients in remission.", - "NCTID": "NCT00796913" - }, - { - "brief_title": "Block-replacement Therapy During Radioiodine Therapy", - "phase": "Phase 4", - "drugs": "['MTZ+LT4', 'Methimazole']", - "drugs_list": [ - "MTZ+LT4", - "Methimazole" - ], - "diseases": "['Toxic Nodular Goitre', \"Graves' Disease\"]", - "diseases_list": [ - "Toxic Nodular Goitre", - "Graves' Disease" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Hyperthyroid patients going to be treated with radioiodine either due to recurrent Graves' disease or toxic nodular goiter. \n\n ", - "exclusion_criteria": ": \n\n Age < 18 yrs. \n\n Allergy to anti-thyroid drugs \n\n Substernal or large (> 100ml) goiter \n\n Severe endocrine ophthalmopathy \n\n Pregnancy or lactation \n\n Suspicion of thyroid malignancy \n\n Unsafe contra-conception \n\n Physical or mental condition that hinders corporation", - "brief_summary": "Background: The use of radioactive iodine (131I) therapy as the definite cure of hyperthyroidism is widespread. According to a survey on the management of Graves' disease, thirty per cent of physicians prefer to render their patients euthyroid by antithyroid drugs (ATD) prior to 131I therapy. This strategy is presumably chosen to avoid 131I induced 'thyroid storm', which, however, is rarely encountered. Several studies have consistently shown that patients who are treated with ATD prior to 131I therapy have an increased risk of treatment failure. Mostly, patients with Graves' disease have been studied, while other studies were addressed also toxic nodular goiter. Thus, it is generally accepted that ATD have 'radioprotective' properties, although this view is almost exclusively based on retrospective data and is still under debate. Indeed, this dogma was recently challenged by two randomized trials in Graves' disease, none of which showed such an adverse effect of methimazole pretreatment. It cannot be excluded that the earlier results may have been under influence of selection bias, a source of error almost unavoidable in retrospective studies. Whether ATD is radioprotective also when used in the post 131I period has also been debated. In the early period 131I therapy following a transient rise in the thyroid hormones is seen which may give rise to discomfort in some patients. The continuous use of ATD during 131I therapy, possibly in combination with levothyroxine (BRT: block-replacement therapy), leads to more stable levels of the thyroid hormones. By resuming ATD following 131I therapy, euthyroidism can usually be maintained until the destructive effect of 131I ensues. Nevertheless, many physicians prefer not to resume ATD, probably due to reports supporting that such a strategy reduces the cure rate. Parallel to the issue of ATD pretreatment, the evidence is based on retrospective studies and the ideal set-up should be reconsidered. To underscore the importance of performing randomized trials we showed recently that resumption of methimazole seven days after 131I therapy had no influence on the final outcome.~Aim:To clarify by a randomized trial whether BRT during radioiodine therapy of hyperthyroid patients influences the final outcome of this therapy, in a comparison with a regime in which methimazole as mono-therapy is discontinued 8 days before radioiodine.~Patients and Methods: Consecutive patients suffering from recurrent Graves' disease (n=50) or a toxic nodular goiter (n=50) are included. All patients are rendered euthyroid by methimazole (MMI) and randomized either to stop MMI eight days before 131I or to be set on BRT. This latter medication continues until three months after 131I. Calculation of the 131I activity (max. 600 MBq) includes an assessment of the 131I half-life and the thyroid volume. Patients are followed for one year with close monitoring of the thyroid function.", - "NCTID": "NCT00150124" - }, - { - "brief_title": "Thyroid Disease and Personality Study", - "phase": "", - "drugs": "['blood sampling']", - "drugs_list": [ - "blood sampling" - ], - "diseases": "[\"Graves' Disease\"]", - "diseases_list": [ - "Graves' Disease" - ], - "enrollment": "500.0", - "inclusion_criteria": "inclusion criteria: \n\n aged between 20 and 85 years \n\n euthyroid Graves' disease \n\n ", - "exclusion_criteria": ": \n\n Patients who were not capable to complete the questionnaire due to severe cognitive dysfunction or under education were excluded from this study", - "brief_summary": "Observe the relationship between thyroid function and personality traits", - "NCTID": "NCT02620085" - }, - { - "brief_title": "Antithyroid Drugs During Radioiodine Therapy", - "phase": "Phase 4", - "drugs": "['Methimazole']", - "drugs_list": [ - "Methimazole" - ], - "diseases": "['Toxic Nodular Goitre', 'Graves Disease']", - "diseases_list": [ - "Toxic Nodular Goitre", - "Graves Disease" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n Hyperthyroid patients going to be treated with radioiodine either due to recurrent Graves' disease or toxic nodular goiter. \n\n ", - "exclusion_criteria": ": \n\n Age < 18 yrs. \n\n Allergy to anti-thyroid drugs \n\n Substernal or large (> 100ml) goiter \n\n Severe endocrine ophthalmopathy \n\n Pregnancy or lactation \n\n Suspicion of thyroid malignancy \n\n Unsafe contraconception \n\n Physical or mental condition that hinders corporation", - "brief_summary": "Background: The use of radioactive iodine (131I) therapy as the definite cure of hyperthyroidism is widespread. According to a survey on the management of Graves' disease, thirty per cent of physicians prefer to render their patients euthyroid by antithyroid drugs (ATD) prior to 131I therapy. This strategy is presumably chosen to avoid 131I induced 'thyroid storm', which, however, is rarely encountered. Several studies have consistently shown that patients who are treated with ATD prior to 131I therapy have an increased risk of treatment failure. Mostly, patients with Graves' disease have been studied, while other studies were addressed also toxic nodular goiter. Thus, it is generally accepted that ATD have 'radioprotective' properties, although this view is almost exclusively based on retrospective data and is still under debate (13). Indeed, this dogma was recently challenged by two randomized trials in Graves' disease, none of which showed such an adverse effect of methimazole pretreatment. It cannot be excluded that the earlier results may have been under influence of selection bias, a source of error almost unavoidable in retrospective studies. Whether ATD is radioprotective also when used in the post 131I period has also been debated. In the early period 131I therapy following a transient rise in the thyroid hormones is seen which may give rise to discomfort in some patients. The continuous use of ATD during 131I therapy leads to more stable levels of the thyroid hormones. By resuming ATD following 131I therapy, euthyroidism can usually be maintained until the destructive effect of 131I ensues. Nevertheless, many physicians prefer not to resume ATD, probably due to reports supporting that such a strategy reduces the cure rate. Parallel to the issue of ATD pretreatment, the evidence is based on retrospective studies and the ideal set-up should be reconsidered. To underscore the importance of performing randomized trials we showed recently that resumption of methimazole seven days after 131I therapy had no influence on the final outcome.~Aim: To clarify by a randomized trial whether continuous use of methimazole during radioiodine therapy influences the final outcome of this therapy, in a comparison with a regime in which methimazole as mono-therapy is discontinued 8 days before radioiodine.~Patients and Methods: 80 consecutive patients suffering from recurrent Graves' disease or a toxic nodular goiter are included. All patients are rendered euthyroid by methimazole (MMI) and randomized either to stop MMI eight days before 131I or to continue MMI until four weeks after 131I. Calculation of the 131I activity (max. 600 MBq) includes an assessment of the 131I half-life and the thyroid volume. Patients are followed for one year with close monitoring of the thyroid function.", - "NCTID": "NCT00150137" - }, - { - "brief_title": "Post-Radioiodine Graves' Management: The PRAGMA-Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "[\"Graves' Disease\"]", - "diseases_list": [ - "Graves' Disease" - ], - "enrollment": "803.0", - "inclusion_criteria": "inclusion criteria: \n\n Out-patients 18 years of age or over, who have given written informed consent to participate in the study \n\n Diagnosed with Graves' disease \n\n Received radioiodine for treatment of Graves' disease \n\n Had a minimum of 12 months follow-up after RI \n\n Most recent RI dose 5 years ago or less at the time of enrollment \n\n ", - "exclusion_criteria": ": \n\n Patients unable to give informed consent \n\n Age 17 years or younger \n\n Cause of thyrotoxicosis other than Graves' disease \n\n Patients who have had more than one dose of radioiodine can only be included in the study once, using data pertaining to their most recent treatment episode. \n\n Patients who might not adequately understand verbal explanations or written information given in English, or who have special communication needs", - "brief_summary": "Thyroid dysfunction following radioiodine for Graves' disease is common, potentially detrimental and avoidable. A variety of clinical strategies are employed in the post-radioiodine era util the patient is on a stable thyroid hormone replacement regimen, which include the use of anti-thyroid drugs, antithyroid drugs with thyroxine, early thyroxine replacement and watchful monitoring until the onset of hypothyroidism. Which of these is most effective in avoiding dysthyroidism, is unknown. This study aims to address this lack of evidence. It will focus on Graves' disease as this is the commonest cause of thyrotoxicosis and the commonest indication for RI therapy. It will provide an insight into potential strategies for improving important clinical outcomes.", - "NCTID": "NCT01885533" - }, - { - "brief_title": "Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease", - "phase": "Phase 4", - "drugs": "['Potassium Iodide']", - "drugs_list": [ - "Potassium Iodide" - ], - "diseases": "['Graves Disease', 'Hyperthyroidism']", - "diseases_list": [ - "Graves Disease", - "Hyperthyroidism" - ], - "enrollment": "36.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult patients with a clinical diagnosis of Graves Disease \n\n Patients who have selected surgical resection as treatment of their Graves Disease \n\n Prior use of anti thyroid medication so that patient is clinically and biochemically euthyroid \n\n ", - "exclusion_criteria": ": \n\n Patients deemed unfit for surgery by operating surgeon or anesthesist \n\n Patients who are clinically hyperthyroid or have T3 or T4 levels 2X the upper limit of normal", - "brief_summary": "The purpose of this study is to determine whether a brief course of SSKI (saturated solution of potassium iodide) administered preoperatively provides any benefit in the surgical management of patients undergoing thyroidectomy as definitive management of their Graves Disease.", - "NCTID": "NCT00946296" - }, - { - "brief_title": "Color Flow Doppler Ultrasound in Subclinical Thyroid Dysfunction", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Subclinical Hypothyroidism', 'Hyperthyroidism', 'Thyroid Dysfunction']", - "diseases_list": [ - "Subclinical Hypothyroidism", - "Hyperthyroidism", - "Thyroid Dysfunction" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n patients with subclinical hypothyroidism or hyperthyroidism \n\n patients with thyroid nodules and normal thyroid function \n\n ", - "exclusion_criteria": ": \n\n patients who are taking thyroxine, antithyroid drugs, lithium or amiodarone \n\n patients who had thyroid surgery or radioiodine therapy \n\n patients with NYHA class 3 or 4 heart failure", - "brief_summary": "Overt hyperthyroidism and hypothyroidism are associated with inverted hemodynamic changes.Regional blood flow disturbances (including intrathyroidal) were also reported in these thyroid disorders. The purpose of this study is to investigate the thyroid vascularity and blood flow by Color Flow Doppler Sonography in patients with subclinical thyroid dysfunction", - "NCTID": "NCT00437931" - }, - { - "brief_title": "The Effect of Radioactive Iodine Administration for Thyroid Diseases on H.Pylori Eradication", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Helicobacter Pylori Infected Patients', 'Thyroid Cancer Patients', 'Hyperthyroidism']", - "diseases_list": [ - "Helicobacter Pylori Infected Patients", - "Thyroid Cancer Patients", - "Hyperthyroidism" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult patients between the ages of 18 and 80. \n\n Patients with diagnosed thyroid disease referred for thyroid scan or treatment with radioactive iodine (131I). \n\n Patients who provide informed consent \n\n ", - "exclusion_criteria": ": \n\n Patients without diagnosed thyroid disease. \n\n Patients who are pregnant or breast feeding. \n\n Patients who have received previous treatment for H. pylori infection. \n\n Patients taking proton pump inhibitors. \n\n Patients with recent or current use of antibiotics. \n\n Patients allergic to iodine (131I).", - "brief_summary": "Because of the high iodine uptake in the stomach, radioactive iodine treatment for thyroid diseases (cancer or hyperthyroidism) or radioactive iodine administered for thyroid scan may be able to eradicate H.pylori infection from the stomach of patients infected with H.pylori.~Also to test the hypothesis that CagA virulent strains of H.pylori are more common in patients with thyroid cancer than with other thyroid diseases.", - "NCTID": "NCT00822289" - }, - { - "brief_title": "Thyroid Treatment Trial", - "phase": "", - "drugs": "['Intravenous Methylprednisolone + Oral Methotrexate vs Intravenous Methylprednisolone + Placebo']", - "drugs_list": [ - "Intravenous Methylprednisolone + Oral Methotrexate vs Intravenous Methylprednisolone + Placebo" - ], - "diseases": "['Graves Ophthalmopathy']", - "diseases_list": [ - "Graves Ophthalmopathy" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n Confirmed TED (as defined by Bartley and Gorman19) \n\n - Eyelid retraction (upper eyelid margin at or above the superior corneoscleral limbus in primary gaze without frontalis muscle contraction) in association with any one of the following: \n\n Thyroid dysfunction or abnormal regulation (increased serum thyroxine or triiodothyronine level, decreased serum thyroid stimulating hormone level, absence of thyroid radioiodine uptake suppression after administration of triiodothyronine, or the presence of thyroid stimulating immunoglobulins in serum) \n\n Exophthalmos (Hertel measurement of at least 20mm) \n\n Extraocular muscle involvement (restrictive myopathy or objective evidence of enlarged muscles) \n\n Optic nerve dysfunction (abnormal visual acuity, colour vision, pupillary reaction or perimetry not attributable to other causes) \n\n OR \n\n - Thyroid dysfunction or abnormal regulation in association with any one of the following: \n\n -Exophthalmos \n\n - Extraocular muscle involvement \n\n - Optic nerve dysfunction \n\n Active disease \n\n Inflammatory Index \n\n Inflammatory Index \n\n Soft tissue feature Rating Chemosis 0 Absent \n\n Moderate (up to lid margin) \n\n Severe (over lid margin; persists on closing eye) \n\n Conjunctival injection 0 Absent 1 Present \n\n Lid injection 0 Absent \n\n 1 Present \n\n Lid edema 0 Absent \n\n Moderate \n\n Severe (festoons, overhang) \n\n Pain at rest (clearly defined as retrobulbar aching) 0 Absent 1 Present \n\n Pain on movement 0 Absent \n\n 1 Present \n\n Total possible 8 \n\n Active disease is defined as an inflammatory index of at least 3 together with acute or subacute onset (3 months and under) and/or evidence of progression (from history or clinical observation). \n\n (3) Moderate or severe disease \n\n Primary Criteria \n\n Mild Moderate Severe Inflammatory Index <3 3-5 >5 \n\n Motility <1/3 1/3 to 2/3 >2/3 (involving any one muscle) limitation limitation Limitation \n\n Elevation, depression, adduction and abduction of the individual eyes will be measured with a modified Aimarck perimeter with input from both patient and the orthoptist who performs the test 20. \n\n Secondary Criteria 21,22,23,24 \n\n Mild Moderate Severe Exophthalmos (mm) <21 21-24 25 or more \n\n Best corrected vision (Logmar) - - 0.6 or worse \n\n CT criterion (Muscle Diameter Index) 21-24 25-30 31 and above \n\n These criteria are not considered absolutes and emphasize measurable indices based on previous studies. \n\n The presence of at least 1 primary criterion and at least 1 secondary criterion places the patient in the more advanced disease group (in the situation where 1 primary criterion is mild and the other severe, the presence of 1 severe secondary criterion will yield a severe grade whereas absence of this criterion will result in a mild grade) eg 1) a patient with an inflammatory index of 6 and moderate limitation of extraocular motility, 21mm proptosis, 0.3 vision and MDI of 26 has moderate disease as the secondary criteria for severe disease was not present eg 2) a patient with an inflammatory index of 5 and mild limitation of extraocular motility, 21mm proptosis, 0.3 vision and MDI of 30 has moderate disease as 1 primary and 2 secondary criteria for moderate disease were present eg 3) a patient with inflammatory index of 6 and mild limitation of extraocular motility, 20mm proptosis, 0.3 vision and MDI of 21 has mild disease as the secondary criterion for severe disease was absent and the other primary parameter (motility) was graded mild. \n\n (4) Age between 21 - 60 \n\n (5) Written informed consent is obtained \n\n ", - "exclusion_criteria": ": \n\n Previous treatment for TED \n\n Oral steroids (e.g. immunosuppressive dose) for last 3 months, radiotherapy \n\n Intravenous pulsed steroid or methrotrexate therapy \n\n Medically unfit to receive I/V high-dose pulsed methylprednisolone or methotrexate \n\n History of cardiac arrthymias, recent acute myocardial infarction \n\n History of seizure \n\n History of acute bleeding peptic ulcer \n\n History of pulmonary tuberculosis, Hepatitis B carrier, Hepatitis C positivity, HIV \n\n Uncontrolled diabetes or hypertension (to be eligible for the trial, random blood glucose must be < 11.1 mmol/L and blood pressure must be 140/90 or lower#. If above these limits, patients can be treated and reviewed at 2 weeks for enrolment when criteria are met - provided the patient does not have optic neuropathy) \n\n Hepatic dysfunction (Alb, AST, ALT and Alkaline phosphates levels must be within normal range for eligibility) \n\n Renal impairment (Urea and Creatinine levels must be within normal range) \n\n Abnormal blood count (outside normal range) \n\n Others \n\n Fertile females considering becoming pregnant during the course of the study and those not willing to take precautions to avoid pregnancy \n\n Both female and male planning to start a family during the trial period or within 6 months of stopping the drugs \n\n History of seizure \n\n History of mental / psychiatric disorder \n\n Patients with clinical features of optic nerve disc pallor at primary presentation will be excluded", - "brief_summary": "This project will compare the efficacy and safety of 2 methods of disease modification in the treatment of active moderate and severe thyroid orbitopathy. A prospective, randomized, double-blind, parallel, controlled multidisciplinary clinical trial involving Singapore National Eye Centre, National University Hospital, Changi General Hospital, Tan Tock Seng Hospital and University of British Columbia Orbital Services, Singapore Eye Research Institute, Singapore General Hospital Endocrinology and Radiology Departments and Tan Tock Seng Hospital Rheumatology Department is planned. The SingHealth-SGH High Field MR Research Laboratory will be involved in the MR imaging of the trial patients.~Patients who satisfy the inclusion and exclusion criteria will be asked to participate in this trial. After informed consent (Appendix B) is obtained, each patient will be randomized into one of two treatment arms: 1) Intravenous high-dose pulsed methylprednisolone (1 gram infusion over 1 hour per day with a total of 3 doses over 3 days; 4 cycles at 6 weekly intervals) and oral placebo and 2) Intravenous high-dose pulsed methylprednisolone (same dose) plus oral methotrexate 7.5 mg per week for 2 weeks, increased to 10 mg per week for another 2 weeks then 12.5 mg per week for 5 months (total 6 months of methotrexate treatment). Depending on patient response, the dose can be further increased by 2.5mg per week every 4 weeks to a maximum of 20 mg per week. A strict management protocol will be observed for each recruited patient. Patients who develop adverse side effects or need for surgical intervention will receive appropriate treatment (i.e. treatment will deviate from the protocol but will continue to be monitored). Patients who refuse treatment will be observed clinically and with imaging as a natural control group until such time as intervention is accepted.~The patients will have a baseline assessment followed by regular visits to assess treatment response and adverse effects. Observations will include the use of an inflammatory index, motility measurements including quantitative ductions, exophthalmometry readings, palpebral aperture readings and indices of optic nerve function. With regards to the imaging, the patients will be assessed with an initial quantitative CT scan and 3-Tesla MRI scan prior to treatment. After treatment is started, patients will also undergo repeat MRI scan at 24 weeks and 72 weeks to assess quantitative changes with treatment using the Muscle Diameter Index (MDI) and Pixel Value Ratio (PVR) for the inferior rectus, superior rectus, the medial rectus, lateral rectus and orbital fat (Appendix E). Serum and urine will be obtained at the same time intervals as the MRI scan to assess levels of thyroid hormones, thyroid antibodies and urinary glycosaminoglycans (GAGs). Free T4, free T3 and TSH will be recorded to monitor control of hyperthyroidism. Thyroid antibodies measured will include thyroid stimulating immunoglobulin (TSI), thyrotropin-binding inhibition antibody (TB II), thyroid peroxidase antibodies and thyroglobulin antibody. Other tests including the full blood count, urea and electrolytes will be run prior to each dose of steroid treatment and during follow-up to monitor for adverse effects.~The results of the assessments will be analyzed for significant differences in treatment response between the 2 groups. The indices of interest will include the percentage of patients in each group who demonstrate a decrease in the inflammatory index of at least 2 points and the time taken for 50% of patients to show such a decrease. Other parameters that reflect the visual function and motility will be compared at different points in time after starting treatment to observe response and sustainability of response. From the serial MRI scans, quantitative analysis of orbital tissues will be done to identify changes with treatment. Antibody and GAG levels will be analyzed to detect any change with treatment. The types and frequency of adverse side effects in the 2 groups will also be assessed.~80 normal subjects will be recruited for MRI scan of the orbits and brain to obtain normative values for the MDI and PVR for the Asian population (Appendix E). This will include 20 subjects from each of 4 decades (21-30 years, 31-40 years, 41-50 years, 51-60 years).~The normative data will also be used to create a virtual orbital atlas. This aspect of the study will be performed in collaboration with the Labs for Information Technology (A-Star).", - "NCTID": "NCT00348413" - }, - { - "brief_title": "Genetic Polymorphisms Associated With Cigarette Smoking and Risk of Graves' Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "[\"Graves' Disease\"]", - "diseases_list": [ - "Graves' Disease" - ], - "enrollment": "1998.0", - "inclusion_criteria": "inclusion criteria: \n\n Graves' disease patients", - "exclusion_criteria": "", - "brief_summary": "Cigarette smoking is a well-recognized risk factor of Graves' disease and, particularly, Graves' ophthalmopathy. Hence, germline polymorphisms of detoxification genes and genes belonging to the major DNA repair/apoptosis pathways might have an important role in disease susceptibility. In addition, as some of these genes are regulated by thyroid hormones, they could affect the outcome of these patients. Our objective was to assess the influence of the GST, CYP and TP53 gene polymorphisms in the risk of Graves' disease and its outcome.", - "NCTID": "NCT00505011" - }, - { - "brief_title": "Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy", - "phase": "Phase 1; Phase 2", - "drugs": "['Azithromycin']", - "drugs_list": [ - "Azithromycin" - ], - "diseases": "['Graves Ophthalmopathy']", - "diseases_list": [ - "Graves Ophthalmopathy" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of Graves Orbitopathy \n\n Clinical activity score higher than 2 \n\n Must be able to swallow tablets \n\n ", - "exclusion_criteria": ": \n\n sight-threatening Graves Orbitopathy \n\n Diplopia in primary gaze \n\n Macrolide allergy or intolerance", - "brief_summary": "The purpose of this study is to examine the effects of Azithromycin (a macrolide class antibiotic), given three times weekly, for patients with active moderate-severe, non sight-threatening, Graves Orbitopathy.~Indices for follow-up will include:~Clinical activity score~Anti-TSH receptor antibody levels~Thickening of extraocular muscles per ultrasound~Quality of life score for Graves Orbitopathy patients", - "NCTID": "NCT01379196" - }, - { - "brief_title": "Sleep Plus Eating Routines for Weight Loss", - "phase": "Phase 2", - "drugs": "['Weight Loss Education', 'Sleep and Eating Routine']", - "drugs_list": [ - "Weight Loss Education", - "Sleep and Eating Routine" - ], - "diseases": "['Overweight and Obesity']", - "diseases_list": [ - "Overweight and Obesity" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria: \n\n age 21 to 65 \n\n BMI 25 to 45 \n\n sleep 7 hours or less most nights \n\n ", - "exclusion_criteria": ": \n\n use of medications affecting sleep \n\n sleep apnea \n\n shift work", - "brief_summary": "The present study will test the effectiveness of two different approaches for preparing overweight/obese individuals for weight loss: 1)providing important information about weight control, including dispelling common myths; or 2) developing a consistent sleep and eating routine to prepare for the challenges of a weight control intervention.", - "NCTID": "NCT01717352" - }, - { - "brief_title": "Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy", - "phase": "", - "drugs": "['Robot-assisted thyroidectomy', 'Open thyroidectomy']", - "drugs_list": [ - "Robot-assisted thyroidectomy", - "Open thyroidectomy" - ], - "diseases": "['Thyroid Nodule', 'Goiter', 'Thyroiditis', 'Graves Disease']", - "diseases_list": [ - "Thyroid Nodule", - "Goiter", - "Thyroiditis", - "Graves Disease" - ], - "enrollment": "5.0", - "inclusion_criteria": "inclusion criteria: \n\n The patient must have given his/her informed and signed consent \n\n The patient must be insured or beneficiary of a health insurance plan \n\n The patient is available for 12 months of follow-up \n\n The patient is a candidate for total thyroidectomy because of a nodular pathology, a diffuse goiter, thyroiditis, or Basedow's disease \n\n Patient has calcitoninemia < 9 ng/pl \n\n Patient has normal calcemia \n\n Patient has PTH level between 5 ng/l and 75 ng/l \n\n The subject has a normal laryngeal mobility \n\n ", - "exclusion_criteria": ": \n\n The patient is participating in another study \n\n The patient is in an exclusion period determined by a previous study \n\n The patient is under judicial protection, under tutorship or curatorship \n\n The patient refuses to sign the consent \n\n It is impossible to correctly inform the patient \n\n The patient is pregnant \n\n The patient is breastfeeding \n\n The patient is not available for 12 months of follow-up \n\n Subject has a preoperative diagnosis of cancer on fine needle aspiration biopsy of the thyroid or cervical lymph node \n\n Lymph node metastasis strongly suspected clinically and/or sonographically \n\n The subject has an extension of substernal thyroid (diving goiter) \n\n Family history of medullary thyroid cancer \n\n The subject has a history of neck surgery \n\n Contraindication for general anesthesia", - "brief_summary": "The main objective is to compare 12 month complication rates between a new surgical method for thyroidectomy (robot-assisted endoscopic thyroidectomy via a sub-clavical approach) and open thyroidectomy.", - "NCTID": "NCT01320813" - }, - { - "brief_title": "Study of the Efficacy of Local Analgesia as an Adjunct to General Anesthesia in Thyroidectomy and Parathyroidectomy", - "phase": "", - "drugs": "['Superficial Cervical Plexus Block', 'Local Wound Infiltration', '0.9% saline', 'Marcaine']", - "drugs_list": [ - "Superficial Cervical Plexus Block", - "Local Wound Infiltration", - "0.9% saline", - "Marcaine" - ], - "diseases": "['Thyroid Neoplasms', 'Goiter, Nodular', 'Thyroid Nodule', \"Graves' Disease\", 'Hyperparathyroidism']", - "diseases_list": [ - "Thyroid Neoplasms", - "Goiter", - "Nodular", - "Thyroid Nodule", - "Graves' Disease", - "Hyperparathyroidism" - ], - "enrollment": "36.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient \u2265 18 years old \n\n Surgical indication for parathyroidectomy or thyroidectomy \n\n ", - "exclusion_criteria": ": \n\n Patients < 18 years old \n\n Patient with history of chronic opioid use \n\n Patient with chronic pain syndromes \n\n Patient with allergy to marcaine", - "brief_summary": "We aim to study the effect of local anesthetic when used in conjunction with general anesthesia during thyroidectomy or parathyroidectomy. We hypothesize there is equivalent pain control between bilateral superficial cervical plexus block and local wound infiltration when used in conjunction with a general anesthetic.", - "NCTID": "NCT02205801" - }, - { - "brief_title": "Parathyroid Reimplantation in Forearm Subcutaneous Tissue During Thyroidectomy: a Simple Way to Avoid Ipoparathyroidism and Evaluate Graft Function", - "phase": "", - "drugs": "['Thyroidectomy and parathyroid reimplantation in forearm subcutaneous tissue']", - "drugs_list": [ - "Thyroidectomy and parathyroid reimplantation in forearm subcutaneous tissue" - ], - "diseases": "['Thyroid Goiter', 'Thyroid Carcinoma', 'Multinodular Goiter', 'Graves Diseases']", - "diseases_list": [ - "Thyroid Goiter", - "Thyroid Carcinoma", - "Multinodular Goiter", - "Graves Diseases" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients affected by benign thyroid disease undergoing thyroidectomy", - "exclusion_criteria": "", - "brief_summary": "The purpose of this study is to evaluate safety and effectiveness of normal parathyroid tissue reimplantation in forearm subcutaneous tissue in case of accidental removal of parathyroid gland during thyroid surgery.", - "NCTID": "NCT02194920" - }, - { - "brief_title": "A Study Into the Effect of Seprafilm in Open Total Thyroidectomy", - "phase": "", - "drugs": "['Seprafilm (Sanofi, USA)']", - "drugs_list": [ - "Seprafilm (Sanofi", - "USA)" - ], - "diseases": "['Thyroid Carcinoma']", - "diseases_list": [ - "Thyroid Carcinoma" - ], - "enrollment": "19.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 21-75 \n\n Histological confirmation of differentiated thyroid cancer requiring surgery, symptomatic goiters, thyroid nodules requiring histological analysis, or thyrotoxicosis poorly controlled by medication. \n\n Undergoing total thyroidectomy \n\n ", - "exclusion_criteria": ": \n\n Previous neck surgery \n\n Previous neck radiotherapy \n\n Patients with a known history of keloids \n\n Patients with a known history of motility disorders in the upper gastrointestinal tract and preexisting swallowing difficulty. \n\n Patients with metastatic disease; patients with disease that would require postop radiation therapy, radionuclide iodine therapy and any adjuvant therapies. \n\n Patients with advanced disease that would require radical or modified neck dissection \n\n Patients with lobe larger than 10 cm, or nodule larger than 8 cm which require extensive dissection that may confound the study \n\n Patients with connective tissue diseases and chronic diseases on long-term medications that may interfere with wound healings such as steroids", - "brief_summary": "The investigators intend to determine the role of Seprafilm, a popular anti-adhesive agent in minimising internal adhesion formation in the neck after thyroid surgery and therefore reduce swallowing discomfort experienced by patients after surgery.", - "NCTID": "NCT01865838" - }, - { - "brief_title": "The Effects of Mindsets on the Brain's Response to Food Cues", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Obesity']", - "diseases_list": [ - "Obesity" - ], - "enrollment": "35.0", - "inclusion_criteria": "inclusion criteria: \n\n MRI compatibility \n\n 25-55 yrs old \n\n 25-40 BMI \n\n weight stable \n\n right handed \n\n ", - "exclusion_criteria": ": \n\n MRI incompatibility \n\n left handed", - "brief_summary": "Previous studies have shown that obese individuals exhibit greater reward-related brain activity in response to food cues than lean individuals and our group has shown that successful weight loss maintainers who were previously obese and now maintain a healthy weight have increased control-related activity when viewing food cues. These findings suggest key roles for both reward-related brain areas and inhibitory control regions in eating behavior. However, no studies to date have examined (a) whether the response to food cues (i.e., cue-reactivity) can be changed in obese individuals, (b) which strategies are most effective at altering brain response to food cues, or (c) the neural mechanisms that support such change.~Given the omnipresent environmental cues to eat and the association between heightened reward-responsivity and obesity, it is critical to investigate ways to potentially alter food cue-reactivity in the obese. The most widely employed approach for behavioral weight loss treatment is Cognitive Behavioral Therapy (CBT), which incorporates strategies to control and change cognitions (e.g., avoid desire to eat tempting foods by focusing on something else). This approach is sometimes described as change- focused because modifying negative thoughts is assumed to thereby change associated maladaptive emotions and behaviors. Alternatively, emerging evidence suggests Acceptance and Commitment Therapy (ACT), which teaches participants to recognize and accept their cravings as feelings that need not be acted upon, may also be effective in treating obesity. A third strategy often employed in smoking cessation and substance abuse treatment is to focus on the long-term consequences of behaviors, however this form of treatment is not typically used in behavioral weight loss therapy. Thus although each approach is potentially effective, these treatment approaches differ greatly in the cognitive strategies they employ.~The primary aim of the proposed research is to compare a cognitive strategy used in CBT ('CHANGE'), a cognitive strategy emphasized in ACT ('ACCEPT'), and a cognitive strategy used in smoking cessation ('LATER') relative to a control condition ('NOW'), in their effectiveness in altering reward and inhibitory control responses to food cues among obese individuals.", - "NCTID": "NCT01913743" - } - ], - "2": [ - { - "brief_title": "Selenium Supplementation Versus Placebo in Patients With Graves' Hyperthyroidism", - "phase": "", - "drugs": "['Selenium', 'Placebo']", - "drugs_list": [ - "Selenium", - "Placebo" - ], - "diseases": "[\"Graves' Hyperthyroidism\"]", - "diseases_list": [ - "Graves' Hyperthyroidism" - ], - "enrollment": "431.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 years or older. \n\n Active Graves' hyperthyroidism (suppressed TSH (< 0.1) and positive TRAb) measured within the last two months prior to the inclusion date. \n\n Written informed consent \n\n ", - "exclusion_criteria": ": \n\n Major co-morbidity, making the participants unlikely to continuously receive trial intervention in the intervention period. \n\n Previous treatment with radioactive iodine. \n\n Current ATD treatment having been received for more than two months. \n\n Treatment with immunomodulatory drugs, such as cyclosporine A, methotrexate, cyclophosphamide. \n\n Allergy towards the components in the selenium and placebo pills. \n\n Pregnant or breast-feeding women. \n\n Intake of selenium supplementation above 70 \u00b5g per day (70 \u00b5g corresponds to the amount in a multivitamin tablet). \n\n Unable to read and understand Danish. \n\n Lack of informed consent", - "brief_summary": "The purpose of this study is to investigate if selenium supplementation to the standard treatment with anti-thyroid drugs in patients with Graves' hyperthyroidism, will lead to a fewer people with anti-thyroid treatment failure and faster remission, in terms of better quality of life during the first year of treatment and more patients staying in remission.", - "NCTID": "NCT01611896" - }, - { - "brief_title": "Shared Decision Making in Graves Disease - Graves Disease (GD) Choice", - "phase": "", - "drugs": "['Decision Aid']", - "drugs_list": [ - "Decision Aid" - ], - "diseases": "[\"Graves' Disease\", 'Thyroid Disease', 'Hyperthyroidism']", - "diseases_list": [ - "Graves' Disease", - "Thyroid Disease", - "Hyperthyroidism" - ], - "enrollment": "93.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults \u2265 18 years \n\n Diagnosis of Graves Disease \n\n Appointment with endocrinologist to discuss treatment options for Graves Disease \n\n ", - "exclusion_criteria": ": \n\n Major barriers to participate in shared decision making or to providing informed consent (i.e. dementia, severe hearing or visual impairment)", - "brief_summary": "The investigators' decision aid for patients with GD, GD Choice, will be the result of a user-centered participatory action research involving) synthesis of the best available evidence from the literature and real-world registry experience, ii) input and involvement of patients, clinicians and other stakeholders, iii) direct observation of encounters and iv) extensive field-testing. The goal is to create a decision aid that will be rigorously evidence-based, clear and complete, able to be used by clinicians with minimal training time, while satisfying extant standards for rigorous high-quality shared decision making tools.", - "NCTID": "NCT02107794" - }, - { - "brief_title": "Role of the Microbiome in Graves' Orbitopathy", - "phase": "Phase 1; Phase 2", - "drugs": "['LAB4']", - "drugs_list": [ - "LAB4" - ], - "diseases": "[\"Graves' Disease\"]", - "diseases_list": [ - "Graves' Disease" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Group A: Untreated Graves' hyperthyroidism (or within 4 weeks of initiating ATD treatment) \n\n definition hyperthyroidism: TSH decreased, FT4 and /or FT3 increased \n\n definition Graves': diffusely enlarged thyroid gland either by palpation or echograpy, and/or homogeneous thyroid uptake at scintigraphy, or positive TSHRAb \n\n first episode or recurrence of Graves' hyperthyroidism \n\n minimal or no eye signs, defined as lid retraction / lid lag but no other signs. \n\n Planned treatment with antithyroid drugs either titration regimen or block-and-replace regimen for 18 months. \n\n Group B. Untreated Graves' hyperthyroidism (or within 4 weeks of initiating ATD treatment) with overt signs of GO as defined by EUGOGO1 \n\n Mild GO: patients whose features of GO have only a minor impact on daily life insufficient to justify immunosuppressive or surgical treatment. They usually have only one or more of the following: minor lid retraction (<2 mm), mild soft tissue involvement, exophthalmos <3 mm above normal for race and gender, transient or no diplopia, and corneal exposure responsive to lubricants) \n\n Moderate-to-severe GO: Patients without sight-threatening GO whose eye disease has sufficient impact on daily life to justify the risks of immunosuppression (if active) or surgical intervention (if inactive). Patients with moderate-to-severe GO usually have any one or more of the following: lid retraction R2 mm, moderate or severe soft tissue involvement, exophthalmos >3 mm above normal for race and gender, inconstant, or constant diplopia. \n\n Sight -threatening GO: Patients with dysthyroid optic neuropathy (DON) and/or corneal \n\n ", - "exclusion_criteria": ": \n\n Previous or planned treatment with 131I or thyroidectomy (A&B); sight threatening GO requiring decompression (B); drugs interfering with the natural course of GO (A&B): steroids, immunosuppressants, thiazolidinediones, antibiotics / antifungals / antivirals (both topical and systemic for at least 4 weeks prior to recruitment to the study); acute diarrhea illness (gastroenteritis for at least 4 weeks prior to recruitment to the study); Drugs interfering with thyroid function (A&B): amiodarone, lithium, iodine supplements; Drug or alcohol abuse (A&B); no informed consent (A&B); Age less than 18 (A&B); Pregnancy (A&B).", - "brief_summary": "Graves' orbitopathy (GO), also known as thyroid eye disease, affects approximately 3 million people in Europe with an estimated socioeconomic burden of 6.4 billion euros per annum. GO is a complication of Graves' disease which is an autoimmune disease and the commonest cause of an overactive thyroid gland. The treatment of GO remains unsatisfactory and the majority of patients report long-term impairment of quality of life. The effects of gut derived antigens, from micro-organisms and nutrients, on the autoimmune response will be tested in the animal model by probiotic and contra-biotic intervention. In the Indigo interventional trial the investigators will add to the standard anti-thyroid drug treatment (ATD) a specifically designed probiotics (LAB4, Cultech Ltd., West Glamorgan, UK) to assess whether it is possible to modify the microbiome in GD patients and improve their immunological status.", - "NCTID": "NCT02373995" - }, - { - "brief_title": "rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter", - "phase": "Phase 2", - "drugs": "['Recombinant human thyrotropin (Thyrogen)']", - "drugs_list": [ - "Recombinant human thyrotropin (Thyrogen)" - ], - "diseases": "['Benign Nontoxic and Toxic Goiter', \"Graves' Disease\"]", - "diseases_list": [ - "Benign Nontoxic and Toxic Goiter", - "Graves' Disease" - ], - "enrollment": "110.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy volunteers with an intact thyroid gland \n\n Patients with nontoxic/subtoxic nodular goiter confirmed by ultrasonography \n\n Patients with toxic nodular goiter \n\n Patients with Graves' disease \n\n ", - "exclusion_criteria": ": \n\n Treatment with drugs that alter thyroid function or size (the last 3 months prior to inclusion) \n\n Prior 131I treatment \n\n Alcohol, medicine or drug abuse \n\n Pregnancy or lactation \n\n No safe contraception \n\n Participation in another clinical trial \n\n Allergic reaction towards rhTSH \n\n Fine needle biopsy without valid diagnostic criteria for benign disease \n\n Suspicion of malignancy, increased ionized serum calcium and/or serum calcitonin \n\n Incontinence \n\n Physically or psychic condition that hinders corporation \n\n Ischemic attack up till 3 months before inclusion", - "brief_summary": "The trials in this protocol deals with the effect of pretreatment with rhTSH on radioiodine treatment of thyroid size and function, in patients with nontoxic and toxic nodular goiter. It is an introduction of a novel principle, based on prospective, randomized double blind investigations. Attached to this, we investigate the acute effects of rhTSH on thyroid size (measured by ultrasonography), both in healthy individuals and in patients with nontoxic nodular goiter. Thus, the investigations are divided into 4 categories listed below:~Prospective randomized double blind study of pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine in nontoxic multinodular goiter.~Prospective randomized double blind study of the pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine on thyroid size and function in patients with a very large (>100 ml) nontoxic or toxic goiter.~Does administration of 0.9 mg recombinant human TSH affect thyroid function and volume in healthy individuals? A randomized double-blind cross-over trial.~Does administration of 0.3 mg recombinant human TSH affect thyroid function and volume in healthy individuals and in patients with multinodular non-toxic goiter? A randomized double-blind cross-over trial.~As a final note we investigate, in a pilot-study;~The influence of rhTSH on thyroid radioiodine uptake in patients with hyperthyroidism treated with continuous block-replacement therapy.", - "NCTID": "NCT00145366" - }, - { - "brief_title": "Differential Diagnosis of STA-PSV in Thyrotoxicosis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Thyrotoxicosis', 'Peak Systolic Velocity of Superior Thyroid Artery', 'Thyroiditis', 'Graves Disease']", - "diseases_list": [ - "Thyrotoxicosis", - "Peak Systolic Velocity of Superior Thyroid Artery", - "Thyroiditis", - "Graves Disease" - ], - "enrollment": "169.0", - "inclusion_criteria": "inclusion criteria: \n\n newly diagnosed without taking any antithyroid drug or beta receptor blocker with TSH level below the lower limits of reference range \n\n is willing to be enrolled \n\n ", - "exclusion_criteria": ": \n\n unwilling \n\n taking antithyroid drug or beta receptor blocker \n\n taking foods or medicine rich in iodine in 8 weeks \n\n women with pregnant or lactation", - "brief_summary": "Aim: Graves's disease and thyroiditis can both characterized with thyrotoxicosis, but their clinical outcome and therapy is quiet different. Measurement of iodine uptake is the gold standard to differential diagnosis the thyroiditis or Graves's disease. But the iodine uptake is limited for its availability in china and easily influenced by medicine or food contained iodine.The blood pattern of thyroid CFDS is useful for differentiate the cause of thyrotoxicosis.Most previous studies using the descriptive pattern of thyroid CFDS is easily varied by operator subjective judgement. This study is focus on the role of peak systolic velocity of thyroid superior artery in differential diagnosis of thyrotoxicosis. Methods: Patients with thyrotoxicosis symptoms without recent medicine history were enrolled in two clinical center. Its thyroid function, iodine uptake , CFDS of thyroid and peak systolic velocity of thyroid superior artery is detected. Thyrotoxicosis is defined as TSH level below the low value of normal range. Graves disease is defined as the typical symptoms of graves disease such as graves ophthalmopathy or increased iodine uptake. Thyroiditis is defined as lack of typical symptoms of graves disease or decreased iodine uptake.We use receiver operator curve(ROC) to evaluate its diagnosis value", - "NCTID": "NCT01227499" - }, - { - "brief_title": "The Prospective Study of Standard Treatment of Graves Disease Iodine 131 and Prevention of Adverse Reactions", - "phase": "Phase 3", - "drugs": "['Iodine 131']", - "drugs_list": [ - "Iodine 131" - ], - "diseases": "['Hypothyroidism', 'Exophthalmos']", - "diseases_list": [ - "Hypothyroidism", - "Exophthalmos" - ], - "enrollment": "627.0", - "inclusion_criteria": "inclusion criteria: \n\n a typical clinical symptoms of Graves disease, diffuse goiter, eye signs (including exophthalmos), thyroid function (FT3, FT4, rTSH) and thyroid autoantibodies and imaging examinations to confirmed. \n\n ", - "exclusion_criteria": ": \n\n 131I treatment contraindications, those who have not signed the informed consent, failure to complete treatment and follow-up estimates of patients and patients not suitable for radionuclide therapy", - "brief_summary": "Iodine 131 (131I\uff09 treatment on Graves disease and Graves ophthalmopathy relationship has always been the focus of debate. Majority view is that the current treatment does not increase 131I Graves ophthalmopathy, therefore,Graves disease associated with exophthalmos is not a contraindication of 131I treatment. While treatment with corticosteroids, a timely corrective measures to be effective in preventing Graves ophthalmopathy adverse effects. But the merger with severe proptosis in patients with Graves , especially infiltrative exophthalmos , the application of 131I treatment will induce or aggravate not yet reached consensus, so, the 131I treatment is still very careful , mainly due to plaque prospective study and visual assessment is not lack of uniform standards, and a variety of factors (including smoking, work status, and 131I treatment of thyroid doses, etc.) may also interfere or influence the ultimate effect of 131I on the Graves ophthalmopathy. In the view of this situation Graves disease patients with Graves ophthalmopathy could be 131I treatment or not, how to dose adjustments, and the use of which required treatment with systemic issues such as research, explore treatment exophthalmos reduction and mitigation of increased proptosis reasonable treatment of symptoms. To further promote the standardization of 131I treatment of Graves disease on basis.", - "NCTID": "NCT01204359" - }, - { - "brief_title": "Low Doses of Cholestyramine in the Treatment of Hyperthyroidism", - "phase": "", - "drugs": "['Cholestyramine', 'Cholestyramine', 'Placebo powder']", - "drugs_list": [ - "Cholestyramine", - "Cholestyramine", - "Placebo powder" - ], - "diseases": "['Graves Disease']", - "diseases_list": [ - "Graves Disease" - ], - "enrollment": "45.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with newly diagnosed hyperthyroid Graves' disease \n\n ", - "exclusion_criteria": ": \n\n If the patient had been treated previously \n\n diabetes, kidney, or liver disease", - "brief_summary": "The enterohepatic circulation of thyroid hormones is increased in thyrotoxicosis.Bile-salt sequestrants (ionic exchange resins) bind thyroid hormones in the intestine and thereby increase their fecal excretion. Based on these observations, the use of cholestyramine has been tried. The present study evaluates the effect of low doses of cholestyramine as an adjunctive therapy in the management of hyperthyroidism", - "NCTID": "NCT00677469" - }, - { - "brief_title": "Effect of Lugol's Solution in the Patients With Graves' Disease", - "phase": "", - "drugs": "[\"lugol's solution\"]", - "drugs_list": [ - "lugol's solution" - ], - "diseases": "['Graves Disease']", - "diseases_list": [ - "Graves Disease" - ], - "enrollment": "36.0", - "inclusion_criteria": "inclusion criteria: \n\n Graves disease \n\n ", - "exclusion_criteria": ": \n\n Anticoagulant usage, \n\n Previous thyroid operation, \n\n Refused to participate in this study.", - "brief_summary": "Context: Although some of endocrine surgeons administer Lugol's solution to decrease thyroid gland vascularity, there is still no agreement on its effectiveness.~Objective: The aims of this clinical trial are to evaluate thyroid blood flow and microvessel density in the patients with Graves' disease according to the Lugol's solution treatment preoperatively.~Design: Retrospective clinical trial. Setting: A tertiary referral center. Method: Thirty-six patients were randomly assigned to preoperative medication with Lugol's solution. Patients in group 1 (n=17) received Lugol's solution for 10 days before surgical intervention, whereas patients in group 2 (n=19) didn't receive it.~Main Outcome Measures: Blood flow through the thyroid arteries of patients with Graves' disease was measured by color flow Doppler ultrasonography. The microvessel density (MVD) was assessed immunohistochemically and Western blot analysis using the level of expression of CD-34 in thyroid tissue. The thyroid gland's weight and blood loss were measured in all patients.", - "NCTID": "NCT00432146" - }, - { - "brief_title": "Rituximab in the Treatment of Graves' Disease", - "phase": "Phase 1; Phase 2", - "drugs": "['Methimazole', 'Rituximab', 'Immunization with various vaccines']", - "drugs_list": [ - "Methimazole", - "Rituximab", - "Immunization with various vaccines" - ], - "diseases": "['Graves\u00b4 Disease', 'Thyroid Associated Ophthalmopathy']", - "diseases_list": [ - "Graves\u00b4 Disease", - "Thyroid Associated Ophthalmopathy" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Graves\u00b4 disease \n\n Adequate anticonception in women. \n\n ", - "exclusion_criteria": ": \n\n Performance status >2 \n\n Previous rituximab treatment \n\n Immunosuppressive treatment \n\n Serious concomitant disease \n\n Active infections \n\n Pregnancy / breast feeding.", - "brief_summary": "Aim:~In a phase II pilot study encompassing 20 patients with Graves' disease to evaluate the effect of rituximab:~1. Biochemically as assessed by markers of disease activity ( free T4, free T3, TSH, TSH-receptor antibodies, anti-TPO)", - "NCTID": "NCT00150111" - }, - { - "brief_title": "Doxycycline Treatment in Mild Thyroid-Associated Ophthalmopathy", - "phase": "Phase 2", - "drugs": "['Doxycycline hyclate', 'Placebo']", - "drugs_list": [ - "Doxycycline hyclate", - "Placebo" - ], - "diseases": "['Graves Ophthalmopathy', 'Graves Disease', 'Thyroid-associated Ophthalmopathy', 'Thyroid Diseases', 'Endocrine System Diseases', 'Eye Diseases, Hereditary', 'Hyperthyroidism', 'Autoimmune Diseases', 'Immune System Diseases']", - "diseases_list": [ - "Graves Ophthalmopathy", - "Graves Disease", - "Thyroid-associated Ophthalmopathy", - "Thyroid Diseases", - "Endocrine System Diseases", - "Eye Diseases", - "Hereditary", - "Hyperthyroidism", - "Autoimmune Diseases", - "Immune System Diseases" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of Thyroid-associated ophthalmopathy \n\n Mild TAO \n\n Normal serum free thyroxine and free triiodothyronine concentrations \n\n No previous specific therapy for TAO, except for local measures \n\n Written informed consent is obtained \n\n ", - "exclusion_criteria": ": \n\n Pregnant females as determined by positive (serum or urine) hCG test at screening or prior to dosing, or lactating females \n\n Uncontrolled diabetes or hypertension \n\n History of mental / psychiatric disorder \n\n Hepatic dysfunction (Alb, AST, ALT and Alkaline phosphates levels must be within normal range for eligibility) \n\n Renal impairment (Urea and Creatinine levels must be within normal range) \n\n Tetracycline allergy or intolerance", - "brief_summary": "The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50 mg/d), administered for 12 weeks, on patients with mild Thyroid-Associated Ophthalmopathy (TAO).", - "NCTID": "NCT02203682" - }, - { - "brief_title": "Neuropsychologic and Immunological Evaluation in Treatment of Thyroid Diseases. Is Selenium Efficient?", - "phase": "Phase 2", - "drugs": "['selenium', 'placebo']", - "drugs_list": [ - "selenium", - "placebo" - ], - "diseases": "['QoL Before and After 9 Month of Medical Treatment of Graves\u00b4Thyrotoxicosis', 'Potential Effect of Selenium']", - "diseases_list": [ - "QoL Before and After 9 Month of Medical Treatment of Graves\u00b4Thyrotoxicosis", - "Potential Effect of Selenium" - ], - "enrollment": "44.0", - "inclusion_criteria": "inclusion criteria: \n\n New diagnose of autoimmune thyrotoxicosis \n\n biochemically proven with increased thyroxin \n\n low TSH and elevated TRAb/or positive scintigraphy. \n\n Age 18 - 55. Willing to participate - \n\n ", - "exclusion_criteria": ": \n\n No previous head trauma, \n\n No difficulties with swedish language, \n\n No medication which could affective neuropsychological testing, \n\n No planned or ongoing pregnancies. \n\n Normal intellectual capacity. \n\n No severe ophthalmopathy, or other severe disease", - "brief_summary": "Graves thyrotoxicosis is a common autoimmune disease. Patients suffer at diagnosis from weight loss, increased heart rate and stress intolerance. Some patients have difficulties in regaining quality of life. Diagnosis is found through elevated thyroid hormones thyroxin, suppressed TSH (thyroid stimulating hormone) from the pituitary and elevated stimulatory antibodies, TRAb (thyrotropin receptor antibody) to the thyroid. Selenium is sparse in western Europe. This compound has important function in thyroid hormone metabolism and on the immune system. It is not known whether addition of selenium affects the well being of patients with Graves\u00b4thyrotoxicosis. The subject of this study is to investigate this", - "NCTID": "NCT01247077" - }, - { - "brief_title": "Next-generation Sequencing (NGS) of Peripheral Blood Immune Repertoire in Graves' Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Graves Disease']", - "diseases_list": [ - "Graves Disease" - ], - "enrollment": "200.0", - "inclusion_criteria": "Patients with Graves disease", - "exclusion_criteria": "", - "brief_summary": "Graves' disease (MIM 27500) is the leading cause of hyperthyroidism worldwide. The prevalence of Graves' disease is quite high (2.7% in women), and there is solid evidence of genetic predisposition. Despite its clinical and scientific significance, Graves' disease is still mysterious in terms of its susceptibility genes or pathophysiological mechanisms. The immune repertoire, being the sum of T and B lymphocytes in a body at any given time, is both a snapshot and a historical record of a person's immune function. Thanks to the power of next-generation sequencing (NGS), massively parallel sequencing of the B cell and T cell receptors suddenly becomes plausible, and opens a door for many creative approaches to study immune related diseases. The ultimate goal of this project is to use both the NGS deep sequencing and immune repertoire experiment to perform Graves' disease sub-group genetic fine mapping, and to identify Graves' disease-specific T cell and B cell receptors. Furthermore, using the immune repertoire approach, investigators want to study the critical epitopes of thyroid auto-antigens, and to delineate the pathophysiological steps in various disease stages and in various sub-groups. Investigators expect to solve the immune repertoire of Graves' disease of different sub-group presentations and at various disease activity stages.", - "NCTID": "NCT02210741" - }, - { - "brief_title": "Application of Digital Infrared Thermal Imaging (DITI) in Graves' Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "[\"Graves' Disease\"]", - "diseases_list": [ - "Graves' Disease" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Graves' disease patients. Healthy people \n\n ", - "exclusion_criteria": ": \n\n Pregnancy. <16 years old or > 60 years old", - "brief_summary": "Graves' disease is characterized by thyrotoxicosis, goiter, ophthalmopathy and dermopathy. Pathogenesis involves autoimmune process. The investigators think temperatures of the area involved in the inflammation may change. Thus the investigators plan to take temperature pictures of Graves' patients using digital infrared thermal imaging system and observe the change.", - "NCTID": "NCT01182584" - }, - { - "brief_title": "Bone Structure and Strength Evaluated by Extreme-CT Scan Before and After Treatment of Hyper- and Hypothyroidism", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Hyperthyroidism', 'Hypothyroidism']", - "diseases_list": [ - "Hyperthyroidism", - "Hypothyroidism" - ], - "enrollment": "93.0", - "inclusion_criteria": "inclusion criteria: \n\n informed consent, female sex, age 20-85 years, indication for treatment of the thyroid disorder, \n\n ", - "exclusion_criteria": ": \n\n pregnancy, renal insufficiency, known osteoporosis, other disease that may affect bone metabolism, medication which affects bone metabolism, T-score below -3.5, thyroidea ophthalmopathy with indication for steroids,", - "brief_summary": "The aim to evaluate the bone structure by Dexa-scan, extreme CT and bone markers before and one year after treatment for a thyroid functional disorder", - "NCTID": "NCT02005250" - }, - { - "brief_title": "Effect of Childhood Radioiodine Therapy on Salivary Function", - "phase": "", - "drugs": "['Radioiodine']", - "drugs_list": [ - "Radioiodine" - ], - "diseases": "['Xerostomia', 'Hyperthyroidism', 'Thyroid Cancer']", - "diseases_list": [ - "Xerostomia", - "Hyperthyroidism", - "Thyroid Cancer" - ], - "enrollment": "70.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who have been treated with radioiodine therapy \n\n Patients who have never received radioiodine therapy (negative control group) \n\n ", - "exclusion_criteria": ": \n\n Non-English speaking subjects will be excluded due to our lack of translation support resources at this time. Of note, participation in our study cannot benefit participants in any way.", - "brief_summary": "Radioiodine (I-131) therapy for thyroid disease is known to decrease salivary function in adult patients. The impact of pediatric I-131 exposure on salivary function is unknown. The investigators goals are to answer this question by measuring salivary gland function before and after I-131 administration in children who receive radioiodine therapy at our hospital for thyroid disease.", - "NCTID": "NCT02375451" - }, - { - "brief_title": "A Prospective Randomized Equivalence Trial to Evaluate the Safety of the Ligasure in Thyroid Surgery", - "phase": "", - "drugs": "['Ligasure Device']", - "drugs_list": [ - "Ligasure Device" - ], - "diseases": "['Multinodular Goitre', \"Grave's Disease\", 'Thyroid Nodule']", - "diseases_list": [ - "Multinodular Goitre", - "Grave's Disease", - "Thyroid Nodule" - ], - "enrollment": "96.0", - "inclusion_criteria": "inclusion criteria: \n\n multinodular goiter \n\n Grave's disease \n\n thyroid nodule \n\n ", - "exclusion_criteria": ": \n\n thyroid carcinoma \n\n reoperative surgery", - "brief_summary": "This is a randomized, prospective equivalence trial on the safety of the Ligasure Vessel Sealing System as used in thyroid surgery. The Ligasure system is a hand held surgical device that uses heat to seal blood vessels during surgery. It has been a tested and accepted technology in abdominal surgery and it is now being applied to surgery of the thyroid gland because it is faster than the traditional method of tying blood vessels that a surgeon must do manually. To remove the thyroid gland safely the surgeon must dissect the gland away from the recurrent laryngeal nerve which controls the vocal cords and patient's voice. Protecting this nerve is the key step in all thyroid surgery as its damage can permanently alter a patient's voice and even obstruct the airway. At this time the worldwide accepted rate of nerve injury is 2 in 100 patients. The hypothesis of this study is that the nerve injury rates for surgery using the Ligasure device are similar to that seen when surgeons manually tie blood vessels. The investigators protocol will evaluate the function of the recurrent laryngeal nerve after removing the thyroid gland using the Ligasure device in comparison to the traditional method where the surgeon manually ties blood vessels. In this study, for patients undergoing total thyroidectomy for a benign condition, each patient will be randomized to have one lobe of thyroid (left or right) removed using manual tying of blood vessels and the other side will have the surgeon use the Ligasure device to seal blood vessels. Every patient has a pre- and post-operative independent assessment of vocal cord function using nasopharyngoscopy to ensure that the vocal cords are working normally prior to surgery and also to document vocal cord dysfunction if there is an injury to the recurrent laryngeal nerve. The investigators intent is to show that the Ligasure system is a safe method to sealing vessels in thyroid surgery and that the thermal dispersion of this device does not pose a significant increase in risk to the recurrent laryngeal nerve", - "NCTID": "NCT01163565" - } - ] - }, - { - "patient_id": "sigir-20157", - "patient": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", - "0": [ - { - "brief_title": "Reducing the Risk of Developing Major Depression in Adolescents/Young Adults With Minor Depression/Depression Symptoms", - "phase": "", - "drugs": "['motivational interviewing, brief advice in primary care']", - "drugs_list": [ - "motivational interviewing", - "brief advice in primary care" - ], - "diseases": "['Depression']", - "diseases_list": [ - "Depression" - ], - "enrollment": "93.0", - "inclusion_criteria": "inclusion criteria include: \n\n (1) age 14-18 years and \n\n (2) one risk factor for developing depression in the next two years: sub-clinical depressed mood (not meeting criteria of major depression), \n\n a family history of depression in a parent or sibling, or past personal history of depression or personal perception of risk depression and desire to participate \n\n ", - "exclusion_criteria": ": \n\n criteria include meeting criteria or undergoing active treatment for major depression (5 or more symptoms nearly every day with functional impairment, minor depression), \n\n bipolar disorder, \n\n panic disorder, \n\n conduct disorder, \n\n substance abuse or having suicidal ideation. \n\n Active treatment for depression is defined as receiving anti-depressant medication or counseling within one year of remission of symptoms from the most recent episode. \n\n Those who meet DSM-IV criteria for minor depression (3-4 symptoms) or who report significant functional impairment (very difficult or above on the Prime MD functional impairment scale) will be notified and offered a referral for an evaluation by a mental health specialist (and will be strongly encouraged to attend). \n\n Those with 1-2 symptoms of depression will also be offered evaluation and treatment from a mental health specialist. In each case, the primary care physician will be notified and the parents (if under the age of 19).", - "brief_summary": "The purpose of this research study is to assess the feasibility of a combined primary care/web-based depression prevention intervention. Primary care physicians (PCP) currently lack an alternative behaviorally-based approach to antidepressant medications for individuals with depression symptoms or minor depression, but who have not yet developed Major Depression.~The objective of this study is to compare the feasibility and efficacy of motivational interviewing (MI) versus brief advice in primary care to engage adolescents with a web-based depression prevention intervention.", - "NCTID": "NCT00145951" - }, - { - "brief_title": "Interpersonal Psychotherapy for Treatment Resistant Depression", - "phase": "", - "drugs": "['IPT+ antidepressant drugs', 'fluoxetine', 'sertraline', 'paroxetine', 'Citalopram', 'escitalopram', 'fluvoxamine', 'Venlafaxine', 'Duloxetine', 'Bupropion', 'Lithium', 'Risperidone', 'tranylcypromine', 'Imipramine', 'amitriptyline', 'Clomipramine', 'nortriptyline', 'trazodone', 'Mirtazapine', 'sulpiride']", - "drugs_list": [ - "IPT+ antidepressant drugs", - "fluoxetine", - "sertraline", - "paroxetine", - "Citalopram", - "escitalopram", - "fluvoxamine", - "Venlafaxine", - "Duloxetine", - "Bupropion", - "Lithium", - "Risperidone", - "tranylcypromine", - "Imipramine", - "amitriptyline", - "Clomipramine", - "nortriptyline", - "trazodone", - "Mirtazapine", - "sulpiride" - ], - "diseases": "['Treatment Resistant Depression']", - "diseases_list": [ - "Treatment Resistant Depression" - ], - "enrollment": "74.0", - "inclusion_criteria": "inclusion criteria: \n\n Primary diagnose of unipolar treatment resistant depression \n\n ", - "exclusion_criteria": ": \n\n Patients diagnose of: bipolar disorder, psychosis, high suicide risk, Intellectual disability, illicit drug dependence. \n\n Currently in or having received psychotherapy in the last 4 weeks", - "brief_summary": "The purpose of this study is to determine whether combination of antidepressant drugs plus interpersonal psychotherapy is superior to antidepressant drugs alone in treatment resistant depression.", - "NCTID": "NCT01896349" - }, - { - "brief_title": "Enhanced Collaborative Depression Treatment in Primary Care: The RESPECT-D-E Trial", - "phase": "", - "drugs": "['RESPECT-D', 'RESPECT-D-E (Enhanced)']", - "drugs_list": [ - "RESPECT-D", - "RESPECT-D-E (Enhanced)" - ], - "diseases": "['Depressive Disorder, Major', 'Depressive Disorder, Minor', 'Dysthymic Disorder']", - "diseases_list": [ - "Depressive Disorder", - "Major", - "Depressive Disorder", - "Minor", - "Dysthymic Disorder" - ], - "enrollment": "131.0", - "inclusion_criteria": "inclusion criteria: \n\n Males and Females, ages 18 and older who are self-reporting generally good health. \n\n Newly started on an antidepressant medication, switched to a different antidepressant medication or prescribed an increased dosage of antidepressant medication within the past 2 weeks. \n\n A Hamilton Depression Rating Scale (HAM-D) score of greater than 10. \n\n A Patient Health Questionnaire (PHQ-9) score of 10 or greater, with endorsement of depressed mood or anhedonia, and endorsement of impaired daily function. \n\n Meets diagnostic criteria for Major Depressive Disorder, persistent Minor Depressive Disorder (i.e., > 1 month duration), or Dysthymic Disorder via a structured interview with the PRIME-MD. \n\n Able to read, understand, and sign the Informed Consent in English. \n\n Willing and able to comply with study requirements. \n\n Well-versed in using a personal computer and the internet and must have easy access to a computer connected to the internet everyday (both weekdays and weekends). \n\n Enrollment in Surescripts Pharmacy benefit plan \n\n Currently under care with a Provider in Family Medicine at Cheshire Medical Center / Dartmouth-Hitchcock Keene \n\n ", - "exclusion_criteria": ": \n\n Subjects must not have a major psychiatric co-morbid condition (schizophrenia, bipolar affective disorder, obsessive-compulsive disorder, PTSD, or a depressive disorder with psychotic features, as determined from chart review and patient report). \n\n Subjects must not have a substance use disorder or dependence as assessed by: CAGE Alcohol Dependence Questionnaire score >3 \n\n Subjects must not have a history of treatment -resistant depression as defined by the following: Psychiatric hospitalization within the past year; More than 2 clinically ineffective antidepressant medication trials, of adequate duration and adequate dose, within the current depressive episode; Any history of Electroconvulsive Therapy (ECT); A trial of Monoamine Oxidase inhibitor (MAO) within the past year. \n\n Subjects must not report being actively suicidal \n\n Subjects must score 4 or greater on the Callahan Six-Item Cognitive Screening assessment \n\n Subjects must not be diagnosed with a terminal or near terminal medical illness such that their primary care provider has estimated the patient has less than 6 months to live. \n\n Subjects reporting any medical condition that would make it unsafe to participate in a research study. \n\n Participation in any other clinical research study within the past 30 days. \n\n Participation in any on-line depression-related coaching or lifestyle improvement program within the past 5 years.", - "brief_summary": "Primary care physicians have emerged as the predominant mental health care providers for diagnosing and treating depression. The majority of patients with mood disorders receive treatment in the primary care setting, within which approximately 10-30% of all patients present with a depressive disorder. Comprehensive 'Collaborative Care' models of depression management significantly improve depression outcomes and health-related quality of life. Core features of these programs include use of a trained depression care manager to closely coordinate with primary care clinicians, support treatment recommendations, provide patient education, conduct patient follow-up to ensure adequate treatment, and manage as-needed access to psychiatrists for patients with more complex presentations. Evidence based Collaborative Care models do not currently weave in the use of web-based or mobile technologies. These technologies offer unique features that may make collaborative depression care more effective. The digital health coaching program for depressive symptoms enhanced during Phase I of the current project is a web-based tool featuring video, text, links and graphics which provide patients with education, self-management techniques, tailored feedback, and tools for tracking treatment progress. The RESPECT-D (Re-engineering Systems of Primary Care Treatment of Depression) intervention is a collaborative depression management model for primary care. The primary objective of this project is to compare the efficacy of an enhanced Collaborative Care model for depression (RESPECT-D-E) to the standard model (RESPECT-D) for patients with minor and major depression and dysthymic disorder. This study will be a randomized controlled trial with 150 participants who are receiving antidepressant medication treatment in the primary care setting. The primary objectives are: reduction in subject reported depressive symptoms, improvement in subject reported health related quality of life and improvement in subject adherence to treatment regimen as demonstrated by self-report measures and clinician-administered assessment. The investigators hypothesize that compared to RESPECT-D at 12 weeks, participants randomized to RESPECT-D-E will demonstrate: a greater reduction in depressive symptoms, a greater improvement in health-related quality of life and a greater satisfaction with quality of depression care received.", - "NCTID": "NCT01583400" - }, - { - "brief_title": "Cognitive Behavioral Therapy, Self-Efficacy, and Depression in Persons With Chronic Pain", - "phase": "", - "drugs": "['cognitive behavior therapy']", - "drugs_list": [ - "cognitive behavior therapy" - ], - "diseases": "['Depression']", - "diseases_list": [ - "Depression" - ], - "enrollment": "138.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 and over with chronic pain and \n\n score of 27 or higher on CES-D scale \n\n ", - "exclusion_criteria": ": \n\n 17 or younger, no chronic pain, \n\n cognitively unable to participate in programming", - "brief_summary": "The investigators are exploring the role of Cognitive Behavioral Therapy (CBT), a treatment for depression, on self-efficacy (feeling empowered to accomplish a given task) and depression in persons with chronic pain and depression. Past research has shown that persons with chronic pain show improvement in self-efficacy and depression scores when they are using CBT. The Pain rehabilitation Center (PRC) at Mayo Clinic is adding CBT focused groups to better understand the role of CBT on self-efficacy and depression in persons with chronic pain and depression.", - "NCTID": "NCT01055665" - }, - { - "brief_title": "Effects of Interpersonal Psychotherapy on Depression During and After Pregnancy", - "phase": "", - "drugs": "['Interpersonal Psychotherapy (IPT)']", - "drugs_list": [ - "Interpersonal Psychotherapy (IPT)" - ], - "diseases": "['Depression', 'Anxiety Disorders']", - "diseases_list": [ - "Depression", - "Anxiety Disorders" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n No more than 28 weeks pregnant at the time of study entry \n\n History of depression or anxiety \n\n Current symptoms of distress \n\n Score of 9 or greater on the Edinburgh Postnatal Depression Scale (EPDS) \n\n English-speaking \n\n ", - "exclusion_criteria": ": \n\n Plans to move away from the area prior to giving birth \n\n Current use of steroids for medical conditions", - "brief_summary": "This study will evaluate the impact of interpersonal psychotherapy on the course of depression during and after pregnancy, as well as its effect on infant birth outcomes.", - "NCTID": "NCT00380419" - }, - { - "brief_title": "TRIAD - Treatment of Insomnia and Depression", - "phase": "Phase 2; Phase 3", - "drugs": "['Antidepressant', 'Desensitization Therapy for Insomnia', 'Cognitive Behavioral Therapy for Insomnia']", - "drugs_list": [ - "Antidepressant", - "Desensitization Therapy for Insomnia", - "Cognitive Behavioral Therapy for Insomnia" - ], - "diseases": "['Sleep Initiation and Maintenance Disorders', 'Depression']", - "diseases_list": [ - "Sleep Initiation and Maintenance Disorders", - "Depression" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Meets criteria for Major Depressive Disorder \n\n Between 18 and 75 years of age and adequately fluent in English \n\n Meets criteria for an insomnia disorder \n\n ", - "exclusion_criteria": ": \n\n Women who are currently pregnant, breast-feeding, or not using a reliable birth control method. \n\n People for whom the antidepressant medication(s) provided in the study is not indicated \n\n People who have had minimum adequate trials of (or have not been able to tolerate) all three study medications. \n\n People with uncontrolled medical conditions. \n\n People with moderate or severe sleep disorders other than insomnia \n\n Individuals on a fixed night shift or rotating work schedule that requires a night shift. \n\n Patients with a current principal diagnosis of a psychiatric disorder that necessitates treatment that is not offered in the study.", - "brief_summary": "The aim of the proposed three-site study is to increase the rate of full remission from major depressive disorder (MDD) at the end of 16 weeks of treatment for people who experience both major depressive disorder and insomnia.", - "NCTID": "NCT00767624" - }, - { - "brief_title": "Interpersonal Therapy for Depression in Breast Cancer", - "phase": "Phase 4", - "drugs": "['Interpersonal Psychotherapy', 'Problem-Solving Therapy', 'Brief Supportive Psychotherapy']", - "drugs_list": [ - "Interpersonal Psychotherapy", - "Problem-Solving Therapy", - "Brief Supportive Psychotherapy" - ], - "diseases": "['Major Depression']", - "diseases_list": [ - "Major Depression" - ], - "enrollment": "134.0", - "inclusion_criteria": "inclusion criteria: \n\n A primary psychiatric diagnosis of Major Depressive Disorder as defined by: a score of 18 or above in the 17-item Hamilton Depression Scale; Male or female ages 18+; \n\n Ability to give consent \n\n Diagnosis of Breast Cancer \n\n Patients may be either English or Spanish speaking \n\n ", - "exclusion_criteria": ": \n\n Lifetime history of psychosis or bipolar disorder \n\n Patients meeting diagnostic statistic manual for mental disorder criteria for alcohol or substance use disorders who require acute detoxification. \n\n Current suicide risk. \n\n Advanced cancer or other condition that limits remaining life expectancy to less than 6 months. \n\n Patients who are receiving effective medication for Depression", - "brief_summary": "The investigators propose a randomized clinical trial to compare the efficacy of Interpersonal Psychotherapy (IPT), Problem-Solving Therapy (PST), and Brief Supportive Psychotherapy (BSP), in improving depressive symptoms, psychosocial functioning, and quality of life among patients with breast cancer and major depressive disorder (MDD).", - "NCTID": "NCT01191580" - }, - { - "brief_title": "Bending Adolescent Depression Trajectories Through Personalized Prevention", - "phase": "", - "drugs": "['Interpersonal Psychotherapy- Adolescent Skills Training', 'Coping with Stress']", - "drugs_list": [ - "Interpersonal Psychotherapy- Adolescent Skills Training", - "Coping with Stress" - ], - "diseases": "['Depression']", - "diseases_list": [ - "Depression" - ], - "enrollment": "205.0", - "inclusion_criteria": "inclusion criteria: \n\n Currently in the 6th to 11th grades \n\n Adolescent and parent must be English-speaking \n\n Parental consent and adolescent consent \n\n ", - "exclusion_criteria": ": \n\n Presence of current Major Depressive Disorder, dysthymia, bipolar disorder, or significant psychosis \n\n Suicide attempt in the past week or significant suicidal ideation in the past week \n\n Presence of significant psychopathology or significant pervasive developmental delays that would make the group inappropriate", - "brief_summary": "Investigators will combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better bend trajectories of depression that surge throughout adolescence.", - "NCTID": "NCT01948167" - }, - { - "brief_title": "Escitalopram (Lexapro\u00ae) In Patients With Major Depression With Atypical Features", - "phase": "Phase 3", - "drugs": "['Escitalopram']", - "drugs_list": [ - "Escitalopram" - ], - "diseases": "['Atypical Depression']", - "diseases_list": [ - "Atypical Depression" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria: \n\n age 18 to 65 years, \n\n DSM-IV episode of Major Depression non-psychotic with atypical features. \n\n \u226519 score on the 29-item HAM-D, \n\n ability to give informed consent, if patients are of child-bearing potential \n\n A minimum 2-week washout from existing psychotropics (5 weeks for fluoxetine). \n\n ", - "exclusion_criteria": ": \n\n bipolar depression, \n\n Any Axis I psychotic disorder \n\n currently suicidal or suicide risk, \n\n history of substance abuse in the previous 12 months, \n\n history of hypersensitivity to escitalopram, or citalopram \n\n serious or unstable medical disorders, \n\n starting or terminating psychotherapy during the previous 12 weeks, \n\n ECT treatment in the previous 3 months, \n\n pregnancy or planning pregnancy.", - "brief_summary": "Aims of Study:~The aims of this study are 1) to examine the clinical utility of escitalopram in patients with major depression with atypical features; 2) to evaluate the tolerability of escitalopram in major depression with atypical features.~Study hypothesis and objectives. This study is proposed as an open-label study to gather pilot data to examine whether escitalopram has clinical utility in the treatment of major depression with atypical features. Because of the exploratory nature of the design, no specific study hypotheses can be generated regarding efficacy of the drug. Our primary hypothesis is that the effect size of escitalopram in atypical depression will be similar to the effect size of escitalopram in major depression, its FDA approved indication.", - "NCTID": "NCT00610506" - }, - { - "brief_title": "Affective Processing in Depression and Epilepsy", - "phase": "", - "drugs": "['fMRI', 'Hamilton Depression Rating Scale', \"Beck's Depressive Inventory\", 'Interictal Dysphoric Disorder Inventory (IDDI)']", - "drugs_list": [ - "fMRI", - "Hamilton Depression Rating Scale", - "Beck's Depressive Inventory", - "Interictal Dysphoric Disorder Inventory (IDDI)" - ], - "diseases": "['Epilepsy', 'Depression', 'Healthy']", - "diseases_list": [ - "Epilepsy", - "Depression", - "Healthy" - ], - "enrollment": "14.0", - "inclusion_criteria": "For Control Group \n\n inclusion criteria: \n\n Healthy adults of 18 years of age or older. \n\n ", - "exclusion_criteria": ": \n\n Subject has no history of affective disorders \n\n Subject scores higher than 5 on Hamilton Depression Rating Scale \n\n Subject with prior primary diagnosis of any psychotic disorder, bipolar disorder, anxiety disorder, or any other serious medical or neurological disorder \n\n Subject is pregnant \n\n Subject is unable to undergo a MRI \n\n Epilepsy Only Group \n\n inclusion criteria: \n\n Subject is at least 18 years of age \n\n Subject has confirmed temporal lobe epilepsy (TLE) \n\n ", - "brief_summary": "The goal of this study is to determine whether there are unique markers on neuroimaging that are associated with depression in epilepsy.", - "NCTID": "NCT00855725" - }, - { - "brief_title": "Genetic and Neural Predictors of Adolescent Depression", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Major Depressive Disorder']", - "diseases_list": [ - "Major Depressive Disorder" - ], - "enrollment": "100.0", - "inclusion_criteria": "Adult Cohort \n\n A. MDD Mothers Cohort inclusion criteria: \n\n Current or past Major Depressive Disorder \n\n English as first language or English fluency \n\n Biological daughter who meets inclusion/", - "exclusion_criteria": " for High Risk Female Adolescent \n\n B. Healthy Control Mothers Cohort inclusion criteria: \n\n No history of psychopathology \n\n English as first language or English fluency \n\n Biological daughter who meets inclusion/", - "brief_summary": "This study aims to examine the relationship between mood and brain activity in adolescent girls in order to better understand the genetic and neural predictors of adolescent depression. The participants in this study will be healthy female adolescents aged 12-14 and their mothers. They will participate for a total of six months. Adolescent participants will have three study sessions at McLean Hospital, and during two of them, their mothers will also have assessments. Adolescent assessments will include interviews, questionnaires, computer tasks, and collection of a saliva sample for genetic analyses. Their second study visit will include an fMRI scan. Parent assessments will include an interview, questionnaires, and a computer task.", - "NCTID": "NCT01743716" - }, - { - "brief_title": "New Clinical Applications for Internet-based Cognitive Behavior Therapy for Insomnia and Depression", - "phase": "", - "drugs": "['Therapist guided Internet-CBT for insomnia w. extra support', 'Therapist guided Internet-CBT for insomnia', 'Therapist guided Internet-CBT for insomnia and depression', 'Therapist Guided Internet-CBT for depression plus insomnia placebo']", - "drugs_list": [ - "Therapist guided Internet-CBT for insomnia w. extra support", - "Therapist guided Internet-CBT for insomnia", - "Therapist guided Internet-CBT for insomnia and depression", - "Therapist Guided Internet-CBT for depression plus insomnia placebo" - ], - "diseases": "['Insomnia', 'Major Depression', 'Minor Depression']", - "diseases_list": [ - "Insomnia", - "Major Depression", - "Minor Depression" - ], - "enrollment": "440.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical level of Insomnia (more than 10 on ISI) \n\n Meets criteria for Insomnia according to DSM-IV-TR \n\n Enough language skills \n\n Only Trial 1: Meets criteria for Major or Minor Depressive Disorder according to DSM-IV-TR (for minor depression a MADRS-S-level of >19 is required). \n\n ", - "exclusion_criteria": ": \n\n Sleep disorders requiring other treatment \n\n Alcohol/drugs abuse \n\n Started to use or changed the dose of antidepressant drug during the last 2 months \n\n Somatic or psychiatric conditions requiring acute care \n\n Working night shifts \n\n Only Trial 2: Meets criteria for Major or Minor Depressive Disorder according to DSM-IV-TR (for minor depression a MADRS-S-level of >19 is required for exclusion).", - "brief_summary": "This study includes two sub-trials. Both are included in this singe registration since they have parallel inclusion of participants and have been approved by the Swedish ethics board together in one application.~Trial 1 includes patients with both insomnia and major or minor depression. Participants are randomized to either a combined therapist guided Internet-CBT for insomnia and depression, or to Internet-CBT for depression with an addition of a placebo intervention for insomnia. The primary purpose is to evaluate changes in insomnia and depression severity for the combination treatment compared to the depression treatment, after treatment and at 6 and 36 months follow up. A secondary purpose is to evaluate cognitive functioning before and after treatment, as well as cost effectiveness. Recruitment is done in the Stockholm County through mass media and the Internet psychiatry clinic's regular patient recruitment.~Trial 2 includes patients with insomnia who do not meet criteria for major or minor depression. All participants start therapist guided Internet-CBT for insomnia. After 4 weeks patients that are judged to be at risk of treatment failure are randomized to either continued treatment or treatment with added support intended to enhance outcome. The primary purpose is to evaluate change in insomnia severity for participants who get added support, compared to continued treatment with regular support level. A secondary purpose is to evaluate cognitive functioning before and after treatment, as well as cost effectiveness. Recruitment is done in the Stockholm County through mass media and the Internet psychiatry clinic's regular patient recruitment.~NOTE:~The first participants in trial 1 will be regarded as pilots, due to problems with the experimental treatment: technical issues as well as problems with the design of treatment modules. These problems were corrected when discovered. 12 participants in the experimental arm were affected by these errors. The pilot participants will not be included in the main analyses of data. This was decided upon on 31st of October 2014.", - "NCTID": "NCT01663844" - }, - { - "brief_title": "Duloxetine for the Treatment of Postpartum Depression", - "phase": "", - "drugs": "['duloxetine']", - "drugs_list": [ - "duloxetine" - ], - "diseases": "['Postpartum Depression', 'Major Depressive Disorder']", - "diseases_list": [ - "Postpartum Depression", - "Major Depressive Disorder" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n adult female subjects age 18 and above if onset of depression within 4 weeks of delivery,or onset of depression antenatally either during pregnancy or before pregnancy \n\n must score greater than or equal to 12 on the Edinburgh Postnatal Depression Scale \n\n speak English or Spanish \n\n have access to a telephone \n\n provide written and verbal consent \n\n ", - "exclusion_criteria": ": \n\n have current or lifetime psychosis \n\n an unstable medical condition \n\n hypertension \n\n narrow-angle glaucoma \n\n liver disease \n\n seizure disorders \n\n bulimia \n\n anorexia \n\n mania \n\n substance abuse disorders \n\n have a known hypersensitivity to duloxetine or any of the active ingredients \n\n are in need of inpatient hospital treatment with an excluded medication \n\n adolescents under the age of 18 \n\n Medication Exclusion \n\n other antidepressants \n\n antipsychotic agents \n\n quinolone antibiotics \n\n Type 1C antiarrhythmics \n\n daily benzodiazepines \n\n Treatment with a monoamine oxidase inhibitor", - "brief_summary": "The purpose of this study is to assess whether the antidepressant, duloxetine, is equally effective as a treatment for subjects who have a Postpartum Onset Depression compared to subjects who have an onset of Major Depressive Disorder prior to delivery. The hypothesis is that duloxetine will be as effective in subjects with Postpartum Major Depressive Disorder as in subjects with a Major Depressive Disorder.", - "NCTID": "NCT00617045" - }, - { - "brief_title": "Phenotype Depression Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Major Depressive Disorder']", - "diseases_list": [ - "Major Depressive Disorder" - ], - "enrollment": "279.0", - "inclusion_criteria": "inclusion criteria: \n\n age 21-65 years including males, females and minorities \n\n diagnosis of DSM-IV major depression or Bipolar I or II with current episode of depression \n\n HDRS-17 > 20 and HDRS-24 > 24 \n\n negative pregnancy test for women of childbearing potential \n\n not breast feeding \n\n stable on current dose of psychotropic medication or free from all psychotropic medications for 4 weeks prior to EUH CIN admission (8 weeks for fluoxetine) \n\n no suicide attempt within six months of screening \n\n ", - "exclusion_criteria": ": \n\n evidence of untreated or poorly controlled endocrine, cardiovascular, pulmonary, hematological, renal, or neurological disease \n\n history of CNS trauma or active seizure disorder requiring medication unless otherwise approved by principle investigator \n\n autoimmune or inflammatory disorder of any kind \n\n chronic infection (e.g. hepatitis B or C or HIV) \n\n chronic use of agents known to affect the immune system including glucocorticoid therapy within the past 1 year, methotrexate within the past 1 year, chemotherapy of any kind (past or present), immunotherapy of any kind (past or present), aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) (within the past 2 weeks) and statins (within the past 1 month) unless otherwise approved by principle investigator \n\n hemoglobinopathies (e.g. thalassemia) \n\n a positive pregnancy test \n\n organ transplants \n\n cancer of any type \n\n a score of <28 on the Mini Mental Status Exam (MMSE)unless otherwise approved by principle investigator \n\n meets criteria for schizophrenia (Given overlap of generalized anxiety disorder (GAD) with major depression, GAD will not be exclusionary) \n\n current eating disorders \n\n active abuse of alcohol or illicit/prescription drugs within the past year unless otherwise approved by principle investigator. \n\n MGH-S >3 unless otherwise approved by principle investigator \n\n BMI >40 unless otherwise approved by the principle investigator \n\n active suicidal intent or plan and a score >2 on the HDRS suicide item (item #3). \n\n any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with participating in or completing the protocol", - "brief_summary": "To facilitate the development of a personalized approach to the treatment of patients with major depression, this study is designed to elaborate the clinical and neurobiological phenotype of depressed patients with increased inflammation. The data obtained in this proposal will allow the investigators to test the hypothesis that depression and inflammation interact to elaborate a relatively discreet phenotype that warrants an individualized approach to diagnosis and treatment of patients with depression. Moreover, the identification of specific environmental risk factors for inflammation will foster the elaboration of preventative strategies for patients at risk.", - "NCTID": "NCT01426997" - }, - { - "brief_title": "Simulated Dawn Med Students", - "phase": "", - "drugs": "['Simulated Dawn Light Box', 'Sleep Hygiene instructions']", - "drugs_list": [ - "Simulated Dawn Light Box", - "Sleep Hygiene instructions" - ], - "diseases": "['Depression', 'Anxiety', 'Fatigue', 'Sleepiness', 'Sleep Disruption']", - "diseases_list": [ - "Depression", - "Anxiety", - "Fatigue", - "Sleepiness", - "Sleep Disruption" - ], - "enrollment": "46.0", - "inclusion_criteria": "inclusion criteria: \n\n Being a first year medical student \n\n Good academic standing after the first module \n\n Reporting attending morning lectures regularly. \n\n ", - "exclusion_criteria": ": \n\n No reported history of psychiatric illness,sleep illness, ophthalmic illness \n\n No current use of photosensitizing medications", - "brief_summary": "Medical students score higher than the general population on measures of depression, anxiety, fatigue, poor sleep and sleepiness. Data suggest that disparages in circadian phase might contribute to these problems. From an internal validity standpoint, first year medical students are an ideal group to study. The majority of the students will be matched on variables such as education, age, and intelligence. However, more importantly, they have a nearly identical life style when it comes to factors such as schedule, living conditions, level of stress, and timing of stressors. The specific aim and hypothesis is:Medical students randomized to sleep hygiene counseling plus simulated dawn will report less depression, anxiety, fatigue, sleepiness, and sleep disruption (as measured by standardized questionnaires) than students randomized to just sleep hygiene counseling.", - "NCTID": "NCT02088593" - }, - { - "brief_title": "Exploratory Study on the Mood and Cytokine Levels in Female Healthy Participants and Major Depressive Disorder Patients", - "phase": "Phase 1", - "drugs": "['Placebo', 'Salmonella typhi vaccine (Typhim Vi)']", - "drugs_list": [ - "Placebo", - "Salmonella typhi vaccine (Typhim Vi)" - ], - "diseases": "['Major Depressive Disorder']", - "diseases_list": [ - "Major Depressive Disorder" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Has body mass index (BMI) [weight in kilograms / (height in meters x height in meters)] between 18 and 30 kg/m2 \n\n For young healthy participants: female, 25 to 45 years of age; elderly healthy participants: female: \u2265 65 years of age & with baseline C-reactive protein (CRP) > 5 mg/mL; (partially) remitted MDD patients: female, 25 to 45 years of age \n\n inclusion criteria specific for patients with MDD: -Patients with a history (within 24 months) of MDD must have a Montgomery-Asberg Depression Rating Scale (MADRS) total score < 15 and symptom remission (temporary absence of disease symptoms) relative to the acute episode must have been present for at least 3 months \n\n ", - "exclusion_criteria": ": \n\n Has a current Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) axis I diagnosis (other than MDD) \n\n Has recently experienced a psychosocial stressor within 6 months \n\n Has acute symptoms of suicidality (the likelihood of an individual completing suicide) \n\n Has a DSM-IV diagnosis of substance abuse or dependence within 6 months prior to screening evaluation \n\n Has been exposed to an experimental medication or experimental medical device within 90 days before screening \n\n Has a serology (scientific study of blood serum and other bodily fluids) positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or HIV antibodies at screening \n\n Has been exposed to typhoid or typhoid vaccine within 5 years before screening \n\n Has been prior exposed to the Trier Social Stress Test (TSST) \n\n Has received electroconvulsive therapy (shock therapy) within 3 months before screening \n\n Has been involuntarily committed to psychiatric hospitalization \n\n Has donated 1 or more units (approximately 450 mL) of blood or had an acute loss of an equivalent amount of blood within 90 days prior to study medication administration", - "brief_summary": "The purpose of this study is to explore the effect of an inflammatory and a psychosocial stressor and the combination thereof on mood in healthy young and elderly participants and patients with Major Depressive Disorder (MDD).", - "NCTID": "NCT01533285" - }, - { - "brief_title": "Service Member Fatigue and Lack of Motivation Following Concussion", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Fatigue', 'Traumatic Brain Injury']", - "diseases_list": [ - "Fatigue", - "Traumatic Brain Injury" - ], - "enrollment": "45.0", - "inclusion_criteria": "inclusion criteria mTBI GROUP: \n\n Diagnosis of at least one mTBI during deployment; \n\n At least six months from time of injury; \n\n Age range 18 or older; \n\n A self-report of somatic or behavioral symptoms that developed within 3 months following mTBI and were not present before injury, and may or may not be present at enrollment: \n\n Easy fatiguability \n\n Sleep disturbance \n\n Headache or other chronic widespread pain that does not seem related to extremity injury \n\n Emotional lability \n\n Lack of spontaneity or apathy \n\n Lack of motivation \n\n Feelings of anxiety \n\n Personality change that they or others have noticed \n\n Irritability or aggressiveness \n\n The mTBI participant provides informed consent. \n\n ", - "exclusion_criteria": " mTBI GROUP: \n\n Daily use of stimulants, narcotics, hypnotic or anxiolytics \n\n Diagnosis of sleep apnea, thyroid disorder, or rheumatoid arthritis \n\n Any history of head injury associated with a loss of consciousness that lasted longer than 24 hours (not including sedation); \n\n Daily use of more than 600mg caffeine (equivalent to approximately five cups of coffee). \n\n Headaches more than once a month prior to deployment; \n\n Pregnancy; \n\n Claustrophia; \n\n Inability to comfortably lie supine for two hours \n\n inclusion criteria companion group \n\n Chosen by a mTBI participant as a close companion (i.e, spends or in the last 3 years has spent a minimum of 1 hour per week on average with the mTBI participant and with whom the mTBI participant is comfortable discussing personal matters); \n\n The companion provides informed consent. \n\n ", - "brief_summary": "Background:~- Many service members have reported feeling tired, a loss of motivation, mood changes, and problems working with others after they have a concussion during deployment. These problems may lead to problems with their job and relationships. This study hopes to figure out what parts of the brain may be affected in people with these problems after a concussion.~Objectives:~- To learn more about the problems that may occur after service members have a concussion during deployment and return home.~Eligibility:~Service members or veterans between 18 and 40 years of age who have had a mild traumatic brain injury (concussion) in the past 6 months.~Companions (at least 18 years of age) of the service members will also be included in this study. Companions will have interacted with the service member at least 1 hour a week since deployment.~Design:~Service members will have 1 week of tests at the National Institutes of Health Clinical Center. Companions will have 2 days of tests at the Center.~Each day, service members will have 4 or 8 hours of tests. Tests will include a medical history and physical exam, neuropsychological tests and imaging studies. The tests will ask about fatigue, stress, mood, pain, daily activities, and family support. The imaging studies will measure brain function at rest and during activity.~Companions will have a medical history and physical exam. They will also complete several questionnaires about themselves as well as the service member/veteran. The tests will ask about fatigue, stress, mood, pain, daily activities, and family support....", - "NCTID": "NCT01496586" - }, - { - "brief_title": "Randomized, School-based Effectiveness Trial of the Adolescent Depression Awareness Program", - "phase": "", - "drugs": "['Adolescent Depression Awareness Program (ADAP)']", - "drugs_list": [ - "Adolescent Depression Awareness Program (ADAP)" - ], - "diseases": "['Adolescent - Emotional Problem', 'Depression', 'Prevention Harmful Effects']", - "diseases_list": [ - "Adolescent - Emotional Problem", - "Depression", - "Prevention Harmful Effects" - ], - "enrollment": "17000.0", - "inclusion_criteria": "inclusion criteria: \n\n enrolled in one of the participating schools parental consent and student assent is required for the web-based survey \n\n ", - "exclusion_criteria": ": \n\n not enrolled in the participating schools", - "brief_summary": "The primary goal of the proposed research is to assess the effectiveness of the Adolescent Depression Awareness Program (ADAP), a school-based depression education program, in increasing depression literacy and treatment seeking in high school students. The ADAP intervention will be carried out in approximately 60 schools with over 15,000 students. The following are ADAP Implementation Sites: Baltimore Archdiocese High Schools; New Castle County, Delaware; Washtenaw County, Michigan; and York County, Pennsylvania.", - "NCTID": "NCT02099305" - }, - { - "brief_title": "Computer-Assisted Cognitive-Behavioral Therapy for Adolescent Depression", - "phase": "", - "drugs": "['Computer-assisted cognitive-behavioral therapy', 'Usual care treatment']", - "drugs_list": [ - "Computer-assisted cognitive-behavioral therapy", - "Usual care treatment" - ], - "diseases": "['Depression']", - "diseases_list": [ - "Depression" - ], - "enrollment": "216.0", - "inclusion_criteria": "inclusion criteria: \n\n Beck Depression Inventory > o = 10 \n\n Meets diagnostic criteria of a depressive disorder according Kiddie Sads Present and Lifetime Version interview (K-SADS-PL) \n\n Parent or caregiver giving informed consent and adolescent giving informed assent \n\n ", - "exclusion_criteria": ": \n\n Suicidal risk requiring in-patient care \n\n Bipolar Disorder \n\n Current substance dependence \n\n Current alcohol dependence \n\n Current psychosis \n\n Low intellectual abilities \n\n Current treatment with antidepressant and/or psychotherapy", - "brief_summary": "Background: Most adolescents suffering depression are treated in primary care clinics. Cognitive-behavior therapy (CBT) is effective in the treatment of adolescent depression. The availability of appropriately trained CBT therapist may be limited, especially in primary care clinics. One way to increase the availability of CBT is to use computer-assisted CBT (c-CBT). It can be effective in the treatment of adults, although the outcomes in adolescents remain unclear.~Purpose: The purpose of this study is to determine whether a computer-assisted cognitive-behavioral therapy is effective for the treatment of depression in adolescents between 15 and 19 years of age in 4 primary care clinics in Santiago, Chile.~Study design: A two-arm single-blind (outcomes assessor) randomized controlled trial will be carried out with 216 adolescents. The efficacy, the adherence, and acceptability of the computerized-assisted cognitive behavioral therapy will be evaluated.", - "NCTID": "NCT01862913" - }, - { - "brief_title": "Retrospective Database Study of Real World Abilify Outcomes in Major Depressive Disorder (MDD)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Depressive Disorder, Major']", - "diseases_list": [ - "Depressive Disorder", - "Major" - ], - "enrollment": "23514.0", - "inclusion_criteria": "inclusion criteria: \n\n \u22651 fill for an augmentation therapy medication from Table 1 during the identification period of 01 January 2005 - 30 November 2008. \n\n 12 months of continuous enrollment with medical and pharmacy benefits each before the index date (pre-index period) and after the index date (post-index period). \n\n \u22651 medical claim with a primary International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) diagnosis for MDD (296.2x, 296.3x, 311.xx) during the pre-index period. \n\n Age \u226518 years as of the year of the pre-index period. \n\n ", - "exclusion_criteria": ": \n\n No pharmacy claims for atypical antipsychotics, mood stabilizers, anxiolytics, anticonvulsants, or stimulants, during the pre-index period. \n\n No medical claims with primary or secondary diagnoses for non-MDD episodic mood disorders or schizophrenia during the pre-index or post-index periods.", - "brief_summary": "To examine the differences in health care utilization and costs between MDD patients on adjunctive aripiprazole therapy and MDD patients on other augmentation therapies.", - "NCTID": "NCT01284218" - }, - { - "brief_title": "Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence", - "phase": "Phase 2", - "drugs": "['Fluoxetine', 'Placebo']", - "drugs_list": [ - "Fluoxetine", - "Placebo" - ], - "diseases": "['Depressive Disorder, Major', 'Cannabis Abuse']", - "diseases_list": [ - "Depressive Disorder", - "Major", - "Cannabis Abuse" - ], - "enrollment": "70.0", - "inclusion_criteria": "inclusion criteria: \n\n DSM-IV diagnosis of current marijuana abuse or dependence, confirmed by SCID-SUD \n\n DSM-IV diagnosis of current major depressive disorder, confirmed by the K-SADS \n\n Marijuana use of at least two days within the week prior to enrollment \n\n Demonstrated adequate levels of depressive symptoms within the week prior to enrollment \n\n ", - "exclusion_criteria": ": \n\n DSM-IV diagnosis of bipolar disorder, schizoaffective disorder, or schizophrenia \n\n Hypo or hyperthyroidism \n\n Significant cardiac, neurological, or kidney impairment \n\n Liver disease (SGOT, SGPT, or gamma-GTP greater than 3 times the normal level) \n\n Use of antipsychotic or antidepressant medication in the month prior to enrollment \n\n DSM-IV dependence on any substance except marijuana or nicotine; alcohol dependence, or history of drug use \n\n History of significant medication side effects from any SSRI antidepressant \n\n Pregnant \n\n Unable to use adequate contraceptive methods for the duration of the study \n\n Inability to read or understand English", - "brief_summary": "Adolescents who are diagnosed with major depressive disorder are often also diagnosed with marijuana dependence. Fluoxetine is an antidepressant medication currently used to treat young people who are diagnosed with major depressive disorder. The purpose of this study is to determine the effectiveness of fluoxetine in treating adolescents and young adults diagnosed with both major depressive disorder and marijuana dependence.", - "NCTID": "NCT00149643" - }, - { - "brief_title": "Sleep Deprivation and Energy Balance", - "phase": "", - "drugs": "['sleep deprivation', 'Normal sleep']", - "drugs_list": [ - "sleep deprivation", - "Normal sleep" - ], - "diseases": "['Sleep Deprivation']", - "diseases_list": [ - "Sleep Deprivation" - ], - "enrollment": "17.0", - "inclusion_criteria": "inclusion criteria: \n\n All subjects will be sedentary. Sedentary will be defined as those with an occupational calorie expenditure that is not estimated at greater than 50% above basal (desk job or light activity at work: on feet 30-50% of the work day) and whose exercise activity is defined as sedentary according to a self-reported activity questionnaire, and confirmed by actigraphy measurements. Sedentary lifestyle will be defined as fewer than four 20 min episodes of moderate or vigorous intensity activity in the previous four weeks. \n\n ", - "exclusion_criteria": ": \n\n We will exclude subjects who have any medical or psychiatric disorders, including history of anxiety or depression, and those taking any medications. \n\n Those found to have depression on a depression screening tool (BDI-II) will be excluded. \n\n Current smokers will be excluded. \n\n All female subjects will undergoing a screening pregnancy test and excluded if positive. \n\n Subjects found to have significant sleep disorders will be excluded. - \n\n Subjects found to have occult coronary artery disease by exercise treadmill testing will be excluded.", - "brief_summary": "Chronic sleep deprivation may constitute an important and potentially correctable behavioral factor in the alarming increase in obesity. There are no definitive experimental studies in humans showing whether sleep deprivation indeed contributes to increased energy intake and/or reduced energy expenditure. The investigators propose a series of novel studies to investigate abnormalities in energy homeostasis imparted by sleep deprivation. The investigators will measure food intake, energy expenditure (basal metabolic rate, thermal effect of food, and non-exercise activity thermogenesis), and neurohormone levels in 24 healthy subjects with normal BMI (20-25 kg/m2). Twelve subjects (6 men and 6 women) will be randomized to sleep deprivation. Measurements will be compared to those obtained in 12 subjects who are randomized to a control group, and are not sleep deprived. The investigators will test the following hypotheses: 1. That sleep deprivation results in positive energy balance (increased caloric intake and decreased energy expenditure, as reflected by decreased non-exercise activity thermogenesis). 2. That dysregulation of appetite and energy expenditure is associated with changes in molecules controlling appetite and metabolism. 3. That changes associated with 8 days of modest sleep deprivation resolve, at least in part, over a 4 day recovery period.", - "NCTID": "NCT01334788" - }, - { - "brief_title": "Multidimensional Assessment of Fatigue in Multiple Sclerosis- Observational Study - Ticino", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Multiple Sclerosis']", - "diseases_list": [ - "Multiple Sclerosis" - ], - "enrollment": "93.0", - "inclusion_criteria": "inclusion criteria: \n\n Definite diagnosis of MS (14,15) or CIS (16);according to the most recent standard criteria \n\n Expanded Disability Status Scale (EDSS) score < 7.0 (17); \n\n Last magnetic resonance imaging (MRI) within the previous 12 months; \n\n Male or female; \n\n >18 years old; \n\n Willing to perform the study procedures; \n\n Signed Informed consent. \n\n ", - "exclusion_criteria": ": \n\n Mini Mental Status Examination (MMSE) score < 24; \n\n Relapse within the last 3 months; \n\n Radiologically isolated syndrome (RIS); \n\n History of drug and/or alcohol abuse; \n\n Any serious general medical condition like decompensated cardiopulmonary disease, cancer or decompensated renal failure, as well as any neurological condition (other than MS) that can interfere with the correct execution of the study design.", - "brief_summary": "Fatigue is a common symptom in patients with multiple sclerosis, however, its nature is not completely understood. Fatigue overlaps often with other symptoms such as somnolence, depression and cognitive disorders, from which it is not always readily distinguished. The evaluation of fatigue and the three most frequently associated symptoms using a multidimensional approach might allow to understand, which methodology is the best indicated to estimate the prevalence of fatigue with greatest accuracy, leading to a better differentiation of the symptoms in the diagnostic setting.", - "NCTID": "NCT02082002" - }, - { - "brief_title": "Internet-CBT for Insomnia", - "phase": "", - "drugs": "['Therapist guided Internet-CBT for insomnia', 'Brief Internet-CBT for insomnia, without support', 'Therapist Guided Internet-CBT for depression']", - "drugs_list": [ - "Therapist guided Internet-CBT for insomnia", - "Brief Internet-CBT for insomnia", - "without support", - "Therapist Guided Internet-CBT for depression" - ], - "diseases": "['Insomnia', 'Depression']", - "diseases_list": [ - "Insomnia", - "Depression" - ], - "enrollment": "191.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical level of Insomnia (more than 10 on ISI) \n\n Meets criteria for Insomnia according to DSM-IV-TR \n\n Enough language skills \n\n Only Trial 2: Meets criteria for Major Depressive Disorder according to DSM-IV-TR \n\n ", - "exclusion_criteria": ": \n\n Sleep disorders requiring other treatment \n\n High consumption of alcohol/drugs that affect sleep \n\n Started to use or changed the dose of antidepressant drug during the last 2 months \n\n Somatic or psychiatric conditions requiring acute care \n\n Working night shifts \n\n Only Trial 1: Meets criteria for Major Depressive Disorder according to DSM-IV-TR", - "brief_summary": "This study includes two sub-trials.~In trial 1 patients suffering from insomnia but not meeting the criteria for depression are randomised to either therapist guided Internet-based CBT for insomnia or to a control group with a non-guided, brief self-help program that acts as a placebo control. The primary purpose is to evaluate reduction in Insomnia severity (compared to placebo) after treatment and at follow-ups at 6-month, 1 year and 3 years. Secondary purpose is to evaluate the costeffectiveness of the treatment and to evaluate if the insomnia treatment has a preventive effect on future depressive episodes. Recruitment is done through mass media and includes all regions of Sweden. Initial assessment based on questionnaires and telephone interviews.~Trial 2 includes patients suffering from both Insomnia and depression. Randomization is done between either CBT for insomnia or CBT for depression (both Internet-based) to evaluate each respective treatment's effect on both insomnia and depression. The patients need for further treatment after the initial one will be measured and used as a secondary outcome. Recruitment is done through mass media but only citizens in the Stockholm area are included since the initial assessment are based on both questionnaires and telephone interviews as well as a visit at a psychiatrist located at the Internet psychiatry clinic in Stockholm.~Both trials will include health economic data and analysis. For the longer follow-up periods (1 and 3 years), registers will be used to analyse consumption of sleep medication and antidepressants as well as general health care utilization.", - "NCTID": "NCT01256099" - }, - { - "brief_title": "Integrated Treatment for Comorbid Depression and Obesity in Adolescents", - "phase": "Phase 1", - "drugs": "['CBT for depression and healthy lifestyle plus exercise', 'CBT for depression']", - "drugs_list": [ - "CBT for depression and healthy lifestyle plus exercise", - "CBT for depression" - ], - "diseases": "['Depression', 'Overweight']", - "diseases_list": [ - "Depression", - "Overweight" - ], - "enrollment": "36.0", - "inclusion_criteria": "inclusion criteria: \n\n Adolescents must: 1) be between the ages of 12 and 18 years (18 year olds must still be in high school and living at home); 2) be at or above the 85th percentile with reference to age and gender-specific Body Mass Index (BMI); 3) have at least one parent available to participate in the treatment protocol; 4) speak English; 5) agree to study participation and random assignment; and 6) be available for follow-up. In order to meet the depressed mood criterion, adolescents must have a primary diagnosis of major depressive disorder (single or recurrent), based on the KSADS-PL with a CGI-Severity \u2265 3 for depression and CDRS \u2265 36. Participants must be healthy, as established by their primary care physician, in order to participate in the exercise program - \n\n ", - "exclusion_criteria": ": \n\n Adolescents will be excluded if: 1) they are currently receiving psychotherapy or participating in another weight loss program (only can have been in a weight loss program in the past); 2) they have a medical condition that would interfere with the prescribed dietary plan or participation in physical activity; 3) they are developmentally delayed such that the intervention materials will not be appropriate; 4) they are actively suicidal at intake; 5) they have not been on a stable dose of a psychostimulant for 6 months to ensure that a recently prescribed psychostimulant is not contributing to weight loss; 6) teens on an SSRI will not be allowed to participate due to potential effects of medication on weight loss; 7) they have a substance abuse or dependence diagnosis; or 8) they have failed a medication or psychotherapy trial for depression in the past.", - "brief_summary": "Lifetime prevalence of major depression is estimated at 28% by age 18 (Lewinsohn et al., 1999), with higher cumulative rates in females (35%) than males (19%). Approximately 17% of children and adolescents in the United States are obese as defined by a BMI above the 95th percentile, with more than 30% falling between the 85th and 95th percentiles (Ogden et al., 2008). Overweight children and adolescents are at increased risk for type 2 diabetes (Pinhas-Hamiel et al., 1996) and overwhelming risk for adult obesity (Guo et al., 1994). There is a substantial percentage of adolescents who are both overweight and depressed with estimates from clinical samples averaging 25%. Treatment of teens with comorbid medical and psychiatric conditions such as overweight/obesity and depression has received little to no attention in the psychosocial treatment research literature. Due to the large number of adolescents who are both depressed and overweight, developing a behavioral treatment that addresses both problems simultaneously has important public health significance. The purpose of this proposal is to combine treatments for depression and overweight to address these co-occurring conditions in one intervention. The long-term objectives of this research are to develop efficient and effective treatments for co-occurring physical and emotional disorders. The research program will be divided into 3 major phases: a development phase (Stage 1a), a pilot study phase (Stage 1b), and a revision phase. During the development phase (Stage 1a), a treatment for overweight teens and CBT treatment for depressed teens will be adapted into one integrated protocol that addresses depression using CBT techniques, an exercise component, and advice regarding healthy eating. As part of this phase, we will adapt existing intervention manuals and therapist training materials, and gain some initial clinical experience with the intervention via an open trial with 6 teens. During the randomized pilot study phase (Stage 1b), the integrated intervention will be compared to a control group receiving CBT treatment for depression alone (N=40 in total). During the pilot phase, the feasibility and acceptability of administering the program will be assessed. In addition, we will compare change in depressed mood at end of treatment and 6 month follow-up periods across the two groups. During the revision phase, the intervention manual will be further developed and refined, based on experiences and observations made during the development and pilot study phases.", - "NCTID": "NCT01128764" - }, - { - "brief_title": "Middle School Matters Study", - "phase": "", - "drugs": "['Positive Thoughts and Actions Program', 'Individual Support Program']", - "drugs_list": [ - "Positive Thoughts and Actions Program", - "Individual Support Program" - ], - "diseases": "['Depression']", - "diseases_list": [ - "Depression" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n 7th and 8th grade students at 4 participating middle schools \n\n Score 14 or above on the Mood and Feelings Questionnaire at screening (approximately top 25%) \n\n No imminent plans to move or change to non-participating school \n\n At minimum 6th grade language skills \n\n Agree to participate in random assignment and research interviews \n\n One Parent/caregiver willing to complete research interviews \n\n ", - "exclusion_criteria": ": \n\n Student with past or current Major Depressive Disorder (MDD) or Probable MDD \n\n Students with parents who do not speak English or Spanish \n\n Students in concurrent treatment \n\n Students in self-contained classroom, or with cognitive delays, or emotional behavioral problems that would preclude them from benefiting from the group or being a good group member \n\n Parent not willing to complete research interviews", - "brief_summary": "This study aims to evaluate the short-term and long-term efficacy of two preventative intervention approaches designed to support middle school youth.", - "NCTID": "NCT01220635" - }, - { - "brief_title": "Efficacy and Safety of Escitalopram for Prevention of Depression Induced by Peg-Interferon in Hepatitis C Patients", - "phase": "Phase 2", - "drugs": "['Escitalopram', 'Placebo']", - "drugs_list": [ - "Escitalopram", - "Placebo" - ], - "diseases": "['Major Depressive Disorder', 'Hepatitis C, Chronic']", - "diseases_list": [ - "Major Depressive Disorder", - "Hepatitis C", - "Chronic" - ], - "enrollment": "133.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with chronic hepatitis C who are going to initiate treatment with peginterferon alfa2a + ribavirin. \n\n Age 18-65 years. \n\n Signed informed consent. \n\n If female, they are not in fertile period or they use barrier contraceptives. \n\n Patients able to understand and fill written questionnaires. \n\n ", - "exclusion_criteria": ": \n\n Hepatic cirrhosis or carcinoma. \n\n Less than 4000/mm3 leucocytes, or less than 70000/mm3 platelets. \n\n Hemoglobin less than 11 g/dL (females) or 12 (males). \n\n Any risk factor for hemolysis. \n\n Comorbid severe medical conditions (kidney, immune system, lung, heart, thyroid, etc). \n\n Baseline mental disorders that require antidepressants (depressive disorders and anxiety disorders). \n\n Other baseline mental disorders (delirium, substance use disorders). \n\n Mental disorders at any time (dementia, psychotic disorders, bipolar disorders. \n\n Contraindications of escitalopram (hypersensibility, diabetes, patients using serotoninergic agents, drugs that enhance the risk of bleeding, or monoamineoxidase inhibitors -MAOIs-).", - "brief_summary": "The purpose of this study is to determine whether the use of an antidepressant (escitalopram) can prevent depressive episodes that appear during the treatment with peg-interferon and ribavirin in patients with chronic hepatitis C.", - "NCTID": "NCT00166296" - }, - { - "brief_title": "Effects of Mirtazapine on Appetite in Advanced Cancer Patients", - "phase": "Phase 2", - "drugs": "['Mirtazapine', 'Placebo']", - "drugs_list": [ - "Mirtazapine", - "Placebo" - ], - "diseases": "['Advanced Cancer', 'Anorexia', 'Weight Loss', 'Insomnia']", - "diseases_list": [ - "Advanced Cancer", - "Anorexia", - "Weight Loss", - "Insomnia" - ], - "enrollment": "98.0", - "inclusion_criteria": "inclusion criteria: \n\n Advanced cancer patients seen in outpatient clinics or inpatient units at MD Anderson Cancer Center, with presence of anorexia for at least one month, and accompanied by weight loss of > 5 % of pre-illness body weight in the last 6 months. Anorexia on the day of enrollment (day 0 +/-3) must be > 4/10 on ESAS. \n\n Patients > 18 years of age \n\n Karnofsky Performance score of > 40 at time of inclusion into study \n\n Ability to provide informed consent and comply with study procedures \n\n Ability and willingness to return to engage in telephone follow-up by research nurse on days 2 (+/- 3 days), 8 (+/- 3 days), 16 ( +/- 3 days), and 22 (+/- 3 days) and return to outpatient clinic for evaluation on days 15 (+/- 3 days), and 29 (+/- 3 days). \n\n Negative urine pregnancy test at time of inclusion into study for female patients of childbearing potential, within 24 hours of study enrollment. \n\n For patients receiving chemotherapy eligibility to be determined after discussion with primary oncologist \n\n Drowsiness of 11 at baseline indicating moderate or severe depression will be excluded from the study and will be referred for appropriate follow up by counselor and psychiatry evaluation. \n\n Patients on chronic use of benzodiazepines are excluded", - "brief_summary": "Primary objective: This is a preliminary study to determine if Mirtazapine in comparison to placebo will improve appetite in advanced cancer patients with anorexia and weight loss. An improvement of appetite is defined as a decrease of 2 in the appetite score from baseline on the Edmonton Symptom Assessment Scale (ESAS) at day 15 (+/-3 days).~Secondary objective-A: To determine if Mirtazapine in comparison to placebo will improve insomnia ( as measured by Pittsburgh Sleep Quality Index) on day 15 ( +/- 3 days), and day 29 ( +/- 3 days)~Secondary objective - B: To determine if Mirtazapine in comparison to placebo will improve other common symptoms such as pain, nausea and fatigue( as measured by ESAS), depression and anxiety ( as measured by Hospital Anxiety and Depression scale), and quality of life ( as measured by Functional Assessment of Anorexia/Cachexia Therapy ) in advanced cancer patients with anorexia/cachexia, on days 15 (+/-3 days), and 29 (+/-3 days)~Other Objectives:~To provide exploratory data on the effects of Mirtazapine on weight gain, and preservation/gain lean muscle mass ( anthropometric measurements and Bioelectric Impedance), on days 15 (+/-3 days), and 29 (+/-3 days).~To provide exploratory data on the effects of a Mirtazapine dose increase to 30 mg on decreased side effects of drug and increased appetite on day 29 (+/-3 days).", - "NCTID": "NCT00488072" - }, - { - "brief_title": "The EARN-Health Trial of Financial Savings and Health", - "phase": "", - "drugs": "['Savings program']", - "drugs_list": [ - "Savings program" - ], - "diseases": "['Depression', 'Anxiety', 'Alcohol Abuse', 'Tobacco Abuse']", - "diseases_list": [ - "Depression", - "Anxiety", - "Alcohol Abuse", - "Tobacco Abuse" - ], - "enrollment": "678.0", - "inclusion_criteria": "inclusion criteria: \n\n English-speaking US residents \n\n ages 18 and older \n\n below 50% of the area median income \n\n have a regular Internet connection \n\n ", - "exclusion_criteria": ": \n\n non-English speakers \n\n non-US residents \n\n children, \n\n history of or current enrollment in other incentivized savings programs", - "brief_summary": "The current literature in social epidemiology and public health suggests that low financial savings has an unsurprising negative relationship with subjective well-being, and increases the odds of making visits to a healthcare provider, receiving a chronic disease diagnosis, and experiencing medical disability. Earn.org is a community-based non-profit based in San Francisco with a mission to help low-income workers build lifelong savings habits and financial capability. The organization is one of the largest providers of goal-based savings accounts or matched savings accounts in the US. The investigators propose to conduct a randomized controlled trial to determine the health effects of Earn's savings program. Through this trial, the investigators will test three principal hypotheses: (1) Participants in the Earn account, as compared to a control group, are hypothesized to demonstrate improved scores on mental health scales assessing depression and anxiety.~(2) Participants in the Earn account, as compared to a control group, are hypothesized to experience lower odds of harmful behaviors associated with stress, specifically tobacco and alcohol abuse. The investigators hypothesize that the effect on behaviors will be of smaller effect size, and more delayed, than the effect on mental health outcomes, judging from similar effects observed in the micro-credit literature.~(3) The mediating variables between Earn account participation and beneficial health outcomes will include increased optimism and internal locus of control.", - "NCTID": "NCT02185612" - }, - { - "brief_title": "The Effects of Ginseng on Cancer-Related Fatigue", - "phase": "Phase 2", - "drugs": "['Panax Ginseng', 'Placebo', 'Questionnaires']", - "drugs_list": [ - "Panax Ginseng", - "Placebo", - "Questionnaires" - ], - "diseases": "['Advanced Cancers', 'Solid Tumors']", - "diseases_list": [ - "Advanced Cancers", - "Solid Tumors" - ], - "enrollment": "158.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients with a histological diagnosis of cancer. \n\n Rate fatigue on a numerical scale during the previous 24 hours as >/= 4 on a 0 to 10 scale (0 = no fatigue and 10 = worst possible fatigue). \n\n Describe fatigue as being present every day for most of the day for a minimum of 2 weeks. \n\n Memorial delirium assessment scale /=8 g/dL within 2 weeks of enrollment. If the patient has not had blood drawn for a hemoglobin level in the previous two weeks, one will be performed to determine eligibility. Patients with a hemoglobin level <9g/dL will be evaluated for treatment of anemia. \n\n Able to understand and sign the informed consent. \n\n No concurrent use of chronic systemic steroids (defined as currently on more than 1 week of treatment). \n\n Controlled pain and depression symptoms, if present ( defined as no change in the Morphine equivalent dose of 30% or change in the dose of antidepressant medication in the past 2 weeks) \n\n Patients should have a Zubrod 1 week of radiation therapy, and if they have been approved to go on study by their primary oncologist. The PI/designated research staff of this study will obtain and document approval from the primary oncologist and principal investigator of the clinical trial in case the patient is on another clinical trial as referenced in the patient's study documents. \n\n Negative pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last 12 months. Pregnancy test to be performed no greater than 14 days prior to consent in study. In cases of women with elevated b-HCG, these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy. Women of childbearing potential need to be on or use contraception, or be abstinent during the study period. Their male partners must also use contraception (condom) or maintain abstinence. Birth controls specifications: Women who are able to become pregnant must use birth control during the study and for 30 days after the last ginseng/placebo dose. Acceptable forms of birth control include barrier methods (such as condom or diaphragm) with spermicide. \n\n ", - "exclusion_criteria": ": \n\n Major contraindication to ginseng: allergy/hypersensitivity to Panax species or their constituents (history of arrhythmias, agitation, or motor tics, or severe angina pectoris). \n\n Currently taking ginseng, methylphenidate or modafinil or have taken it within the previous 10 days. \n\n Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study. \n\n Currently with a diagnosis of major depression, manic depressive disorder, obsessive-compulsive disorder, or schizophrenia). \n\n Symptomatic tachycardia and uncontrolled hypertension (determined to be clinically significant by the PI). \n\n Currently receiving phenobarbital, diphenylhydantoin, primidone, phenylbutazone, MAOIs, clonidine and tricyclic antidepressant drugs \n\n Uncontrolled diabetes mellitus as defined by a random blood sugar of >200mg/dl not being monitored by their primary care physician. \n\n No concurrent full dose anticoagulant therapy. 16, indicating moderate to severe depression; \n\n is between 18 and 50 years old; and \n\n is able to speak and read English sufficiently to be able to complete the study procedures \n\n ", - "exclusion_criteria": ": \n\n meets lifetime criteria for: \n\n bipolar disorder \n\n a primary psychotic disorder \n\n anorexia nervosa \n\n bulimia nervosa \n\n has started an SUD or MDD medication dose within the 8 weeks prior to enrollment \n\n is imminently suicidal", - "brief_summary": "This study will evaluate the effectiveness of Sober Network Interpersonal Psychotherapy (IPT) in treating women with depression and comorbid substance abuse.", - "NCTID": "NCT01550913" - }, - { - "brief_title": "Exploring the Effectiveness of the 'Back of the Net' Intervention on Indices of Physical and Psychological Measures", - "phase": "", - "drugs": "['Exercise', 'Online Cognitive Behavioural Therapy']", - "drugs_list": [ - "Exercise", - "Online Cognitive Behavioural Therapy" - ], - "diseases": "['Self Concept', 'Body Fat Composition', 'Depression', 'Perceived Social Support']", - "diseases_list": [ - "Self Concept", - "Body Fat Composition", - "Depression", - "Perceived Social Support" - ], - "enrollment": "140.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy males aged 18-40 years \n\n Available twice a week for 10 weeks and willing to participate in moderate intensity exercise for 50 minutes at each session \n\n Not regularly physically active (i.e., engages in a structured exercise session once or less per week) \n\n Willing to participate in the internet-based CBT intervention once per week for 10 weeks \n\n ", - "exclusion_criteria": ": \n\n Current illness or history of clinical conditions that prevents participation in exercise \n\n Currently alcohol/drug abusing \n\n Major cognitive or psychiatric impairments \n\n Currently receiving medication for major psychiatric disorders, including depression", - "brief_summary": "To date very little research has focused on the mental health of young men. The main aim of the proposed research is to explore the effectiveness of a combined exercise and internet-based cognitive behavioral therapy (CBT) intervention (called Back of the Net) on indices of suicide risk in young men. A second aim is to explore the relationship between physical self-concept, self esteem, body fat composition, body circumference and changes in depression as a result of an exercise intervention. It is hypothesised that the combined exercise and internet-delivered CBT intervention will have greater benefits for indices of suicide risk compared to an exercise-only intervention, an internet-delivered CBT-only intervention and a control condition.", - "NCTID": "NCT00971217" - }, - { - "brief_title": "The Effects of Thalidomide on Symptom Clusters", - "phase": "Phase 2", - "drugs": "['Thalidomide', 'Placebo']", - "drugs_list": [ - "Thalidomide", - "Placebo" - ], - "diseases": "['Advanced Cancers']", - "diseases_list": [ - "Advanced Cancers" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n Have weight loss of > 5% within the last 6 months \n\n Present with anorexia, fatigue and one of the following: anxiety, depression or sleep disturbances, during the preceding 24 hours, with an average intensity of each symptom >/= 3 on a scale of 0 to 10, in which 0=no symptom, and 10= the worst possible symptom. \n\n Describe the symptoms as being present every day for a minimum of 2 weeks. \n\n Have no clinical evidence of cognitive failure \n\n Must be 18 years or older. \n\n Expect to live at least >/= 4 weeks \n\n Must have negative serum pregnancy test within 24 hours of study enrollment in women of childbearing potential. FDA criteria for the status of not of childbearing potential, hysterectomy, or menopausal for 24 consecutive months. \n\n Understand and sign written informed consent. \n\n Have no concurrent steroids with the exception of steroids used concurrently with chemotherapy as part of a regimen or to reduce nausea. \n\n Willing and able to comply with S.T.E.P.S.[System for Thalidomide Education and Prescribing Safety] \n\n Patient's Absolute neutrophil count (ANC) at time of study enrollment is >/= 750 mm (to be drawn within 14 days prior to registration) \n\n May be on chemotherapy if at a stable dose. Targeted therapies or hormone therapies are permitted once patient has completed two weeks of treatment. \n\n ", - "exclusion_criteria": ": \n\n Have major contraindication to thalidomide, i.e. hypersensitivity. \n\n Present with National Cancer Institute (NCI) Common Toxicity Criteria Grade 3 or more peripheral neuropathy. \n\n Are not able to complete the baseline assessment forms. \n\n Are pregnant or lactating. \n\n Patients with clinical history of seizures \n\n Patients with an ANC of 2.0 mg/dl at baseline will be excluded (to be drawn within 29 days prior to registration). \n\n Patients on Revlimid (lenalidomide). \n\n Patients on investigational chemotherapy/agents.", - "brief_summary": "The goal of this clinical research study is to learn if thalidomide can improve symptoms such as pain, fatigue,anxiety, poor appetite, depression, and sleep problems in patients with advanced cancer.", - "NCTID": "NCT00379353" - }, - { - "brief_title": "Assessment of MDD Management in Andalusia", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['MDD Management Strategies']", - "diseases_list": [ - "MDD Management Strategies" - ], - "enrollment": "5309.0", - "inclusion_criteria": "inclusion criteria: \n\n MDD Diagnosis Participants of the PismaEP study 18 yo. or older \n\n ", - "exclusion_criteria": ": \n\n No specific ", - "brief_summary": "The main objectives of this study are to describe medical professionals responsible of the management of patients with MDD in a representative region of Andalusia (in terms of type of sites managing the disease, and referral to SC criteria); Describe MDD patient characteristics at inclusion in the PISMA-Ep Study; and to evaluate those factors associated to a higher incidence of referral from PC to SC.", - "NCTID": "NCT01510886" - }, - { - "brief_title": "Methylphenidate for Depressed Cancer Patients Receiving Palliative Care", - "phase": "", - "drugs": "['Methylphenidate', 'Placebo', 'Selective Serotonin Uptake Inhibitor (SSRI)']", - "drugs_list": [ - "Methylphenidate", - "Placebo", - "Selective Serotonin Uptake Inhibitor (SSRI)" - ], - "diseases": "['Depression', 'Palliative Care', 'Cancer', 'Mental Disorder']", - "diseases_list": [ - "Depression", - "Palliative Care", - "Cancer", - "Mental Disorder" - ], - "enrollment": "47.0", - "inclusion_criteria": "inclusion criteria: \n\n Inclusion: \n\n Either enrolled in the OHSU radiology/oncology clinic or VA palliative care, and living within 120 miles of the Portland VAMC. \n\n Life-limiting disease is any type of solid or blood cancer. \n\n Eighteen years of age or older. \n\n Life expectancy of 1 year or less as reflected by hospice admission or palliative care status. Although exact life expectancy can not be predicted, actively dying patients with estimated life expectancy of < 10 days are unlikely to be enrolled. \n\n Diagnosis of major depression disorder as determined by the Structured Clinical Interview for Diagnosis (SCID). \n\n Significant depressive cognitive symptomatology as determined by a MADRS greater than 19. \n\n Currently taking an SSRI but still depressed enough to meet eligibility criteria or not taking SSRI but depressed enough to start on SSRI. \n\n Willing and able to give informed consent to participate in this study as demonstrated by the MacArthur Competence Assessment Tool for clinical research. \n\n Speaks/understands English. \n\n For patients at home who cannot self-administer medications, has a caregiver who can assist with administering medication. \n\n ", - "exclusion_criteria": ": \n\n Exclusion: \n\n Dementia or Delirium as determined by the Short Portable Mental Status Questionnaire (SPMSQ) score of less than 7. \n\n Diagnosis of delirium as determined by the Confusional Assessment Method (CAM). \n\n Any of the following Brief Psychiatric Rating Scale (BPRS) items rated 4 -, elated mood, suspiciousness, hallucinations, excitement, distractibility or motor hyperactivity. \n\n Severe insomnia. \n\n Severe anxiety. \n\n Significant suicidal ideation. \n\n History of current mental disorder in which depressive symptoms occur, but for which psychostimulants are contraindicated (schizophrenia and bipolar disorder will be based on history; active psychotic symptoms on selected BPRS items). \n\n History of stimulant abuse or other active, severe substance abuse. \n\n Contraindications to methylphenidate or an SSRI including significant cardiac arrhythmias; uncontrolled, severe hypertension; moderate-severe angina; seizure disorder; severe COPD; use of medications such as Levodopa, monoamine oxidase inhibitors, and lithium; diagnosis of narrow-angle glaucoma; or history of SSRI-induced hyponatremia,. \n\n Physical symptoms including increased blood pressure (DBP greater than 115, SBP greater than 180), pulse greater than 120, irregular pulse, or chest pain consistent with angina. \n\n Treatment for depression with a non-SSRI antidepressant including Bupropion and Venlafaxine during protocol. \n\n Known serum creatinine > 3.0, or severe liver disease as reflected by jaundice or hepatic encephalopathy. \n\n Unable to swallow pills, however if patient has gastrostomy tube or feeding tube in place the study medicines may be administered by this route. Pills may be poured into food. \n\n Receiving hospice care in a skilled nursing facility.", - "brief_summary": "The purpose of this study is to determine whether methylphenidate is an effective treatment for depression and to document the safety and tolerability of methylphenidate in combination with an Selective Serotonin Reuptake Inhibitor (SSRI) in SSRI treated, terminally ill, hospice and palliative care cancer patients. The investigators hypothesize that depressed hospice and palliative care patients will be more likely to have a 50% reduction in scores on a clinical measure of depression after treatment with Methylphenidate plus an SSRI compared to those patients who are taking a placebo plus an SSRI.", - "NCTID": "NCT00129467" - }, - { - "brief_title": "Clinical Registry of Patients Under Treatment With Atypical Antipsychotics", - "phase": "", - "drugs": "['Atypical Antipsychotics']", - "drugs_list": [ - "Atypical Antipsychotics" - ], - "diseases": "['Schizophrenia', 'Major Depressive Disorder', 'Bipolar Depressive Disorder', \"Parkinson's Disease With Hallucinations\"]", - "diseases_list": [ - "Schizophrenia", - "Major Depressive Disorder", - "Bipolar Depressive Disorder", - "Parkinson's Disease With Hallucinations" - ], - "enrollment": "665.0", - "inclusion_criteria": "inclusion criteria: \n\n at least 18 years-old \n\n have a diagnosis of schizophrenia, major depressive disorder, bipolar depressive disorder, parkinson's disease with hallucination \n\n such patients should receive antipsychotics as their usual treatment \n\n they should give informed consent before participating \n\n ", - "exclusion_criteria": ": \n\n no treatment with atypical antypsichotics \n\n other diseases", - "brief_summary": "Antipsychotic drugs are characterized by blocking dopaminergic D2 receptors. They have been found to be effective and safe for the treatment of schizophrenia, bipolar disorders, depressive episodes associated with bipolar disorder, or psychotic symptoms in the context of Parkinson's disease. Atypical antipsychotics have lower blocking potency on D2 receptors, at the time that interact with serotoninergic, adrenergic and histaminergic receptors, among others. Quetiapine extended-release has the same clinical efficacy as the immediate-release formulation, but reduces the amount of daily doses, possibly contributing to increased treatment adherence.~The purpose of this registry is to explore adherence to treatment, the occurrence of adverse drug reactions and the clinical outcomes in a sample of patients under treatment with atypical antipsychotics in several Central American countries. For this study, clinical data will be extracted from the medical records of 1000 patients with schizophrenia, depressive disorders or Parkinson's Disease with hallucinations. Occurrence of adverse drug reactions, namely weight gain, somnolence, extrapyramidal reactions and symptoms of orthostatic hypotension; adherence to treatment; and changes in quality of life and clinical status will be assessed during the first 8 weeks of treatment.", - "NCTID": "NCT02409823" - }, - { - "brief_title": "Efficacy of Ramelteon on Insomnia Symptoms Associated With Jet Lag in Healthy Adult Volunteers", - "phase": "Phase 4", - "drugs": "['Ramelteon', 'Ramelteon', 'Ramelteon', 'Placebo']", - "drugs_list": [ - "Ramelteon", - "Ramelteon", - "Ramelteon", - "Placebo" - ], - "diseases": "['Circadian Dysregulation']", - "diseases_list": [ - "Circadian Dysregulation" - ], - "enrollment": "110.0", - "inclusion_criteria": "inclusion criteria \n\n Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. \n\n Willing to travel from Hawaii to the East Coast and have a minimum stay of 6 days at the destination in a sleep laboratory during the entire study. \n\n Has lived in Hawaii for at least 12 months and has not been traveling outside of Hawaii for 4 consecutive days within 30 days prior to the Outpatient Screening Visit. \n\n History of sleep disturbance associated with jet lag symptoms, with at least two occurrences in the last three years, as defined in the International Classification of Sleep Disorders. \n\n Habitual bedtime should be determined by sleep history as between 9:00 PM and 12:00 AM as determined by sleep history prior to randomization. \n\n Have regular bedtime (within 1 hour) for 1 week prior to travel. \n\n The subject has a subjective sleep latency of less than 30 minutes and a subjective total sleep time of 6.5 hours but less than 9 hours, as determined by sleep history. \n\n Mean subjective sleep latency of less than 30 minutes and a mean subjective total sleep time of greater than 6.5 hours but less than 9 hours in 3 of 5 nights after the outpatient screening visit, as determined by post-sleep questionnaire. \n\n Willingness and ability to comply with study procedures, including travel time, sleep, and waking-hour activities, light-exposure restriction, and food intake. \n\n Body mass index between 18 and 34, inclusive. \n\n Negative test result for selected substances of abuse (including alcohol) at Initial Screening, the In-Patient Actigraphy Screening Nights 1 and 2, and the Treatment Period. \n\n Negative test result for hepatitis B Surface antigen and hepatitis C virus antibody. \n\n ", - "exclusion_criteria": " \n\n Known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds. \n\n History of primary sleep disorders as determined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised within the past 6 months. \n\n Current sleep disorder as assessed by presence of sleep apnea, period leg movement syndrome, insomnia, daytime napping of more than 20 minutes, chronic fatigue. \n\n Ever had a history of seizures, sleep apnea, restless leg syndrome, periodic limb movement syndrome, or chronic obstructive pulmonary disease. \n\n History of psychiatric disorder (including schizophrenia, bipolar disorder, mental retardation, or cognitive disorder, anxiety, or depression) within the past 12 months. \n\n Current, clinically significant neurological (including cognitive), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, as determined by the investigator. \n\n History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised, or regularly consumes more than 14 alcoholic drinks per week. \n\n History of drug abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised. \n\n Positive urine drug screen or a positive urine drug screen or alcohol breathalyzer test. \n\n Sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the administration of single blind study medication. \n\n Positive hepatitis panel including anti- hepatitis A virus (only IgM is exclusionary), hepatitis B surface antigen, or anti- hepatitis C virus. \n\n Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator. \n\n Any additional condition(s) that in the Investigator's opinion would: \n\n affect sleep/wake function \n\n prohibit the subject from completing the study \n\n cause a situation such that it would not be in the best interest of the subject to participate in the study. \n\n Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the administration of study medication. \n\n Smokes greater than 3 cigarettes per day or uses tobacco products during nightly awakenings. \n\n Has flown across greater than 3 time zones within 28 days prior to or during screening. \n\n Reports high caffeine consumption (greater than 600 mg daily). \n\n Participated in any other investigational study and/or taken any investigational drug within 30 days or 5 half-lives of the investigational drug prior to the first dose of double blind study medication, whichever is longer. \n\n Used any central nervous system medication within 1 week (or 5 half lives of the drug, whichever is longer) prior to the administration of study medication. These medications must not have been used to treat psychiatric disorders. \n\n Used prescription or over-the-counter (OTC) hypnotic medication (including melatonin) within 3 months of the screening visits. \n\n Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including: \n\n Anxiolytics \n\n Sedatives \n\n Antidepressants \n\n CNS active drugs (including herbal) \n\n Anticonvulsants \n\n Narcotic analgesics \n\n Sedating H1 antihistamines \n\n St. John's Wort \n\n Systemic steroids \n\n Kava-kava \n\n Respiratory stimulants \n\n Ginkgo-biloba \n\n Decongestants \n\n Over-the-counter and prescription stimulants \n\n Antipsychotics \n\n Over-the-counter and prescription diet aids \n\n Muscle Relaxants Drugs affecting sleep/wake function \n\n Melatonin \n\n Modafinil", - "brief_summary": "The purpose of this study to determine the degree to which ramelteon, once daily (QD), can reduce the insomnia symptoms associated with rapid, eastward travel across 5 time zones.", - "NCTID": "NCT00492011" - }, - { - "brief_title": "Risperidone vs. Bupropion ER Augmentation of SSRIs in Treatment-Resistant Depression", - "phase": "Phase 3", - "drugs": "['Rispridone (drug) and Bupropion ER (drug)']", - "drugs_list": [ - "Rispridone (drug) and Bupropion ER (drug)" - ], - "diseases": "['Unipolar Depression']", - "diseases_list": [ - "Unipolar Depression" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female 18 years or older \n\n DSM-IV diagnosis of major depressive disorder of at least moderate severity, but without psychotic features \n\n Ham-D 17 score of 18 or above \n\n Have a documentable history of 2 prior adequate trials of antidepressants including an SSRI without sufficient response. A clinically adequate trial is defined as having taken a minimum effective dose of an antidepressant for at least 3 weeks without a significant change in depressive symptoms. \n\n Must be currently on an serotonin uptake inhibitor (to include venlafaxine or duloxetine) at an adequate dose for at least 3 weeks. \n\n Ability and willingness to provide consent for participation in the study. \n\n ", - "exclusion_criteria": ": \n\n Any medical condition that would preclude treatment with an SSRI, risperidone, or bupropion ER \n\n Any clinically significant unstable medical condition \n\n Diagnosis of bipolar disorder or a primary diagnosis of any psychotic disorder \n\n Current psychotic symptoms (hallucination or delusions) \n\n Alcohol or drug abuse or dependence in the last 3 months (excluding nicotine and caffeine dependence/abuse) or abuse within the last month \n\n Documented non-response to the combination of a novel antipsychotic or bupropion ER and a SSRI \n\n Concomitant use of any psychotropic other than an SSRI or zolpidem (PRN for sleep) \n\n Score of 4 on the suicide item of the Ham-D scale and determination by the investigator of significant suicide risk \n\n Known sensitivity to risperidone or bupropion ER", - "brief_summary": "The purpose of this study is to evaluate the comparative effectiveness of Risperdal (risperidone) or bupropion ER (extended release) combined with a SSRI medication and to test the relative safety of the combinations.", - "NCTID": "NCT00179244" - }, - { - "brief_title": "Impact of Atypical Antipsychotic Therapy on Health Outcomes and Costs Among Patients With Major Depressive Disorder", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Depressive Disorder, Major']", - "diseases_list": [ - "Depressive Disorder", - "Major" - ], - "enrollment": "501.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who meet the following criteria will be included in the study: \n\n aged 18 to 64 years \n\n diagnosis of major depressive disorder during the study timeframe (ICD 9 codes 296.2, 296.3, 311) \n\n evidence of at least 6 consecutive claims for traditional antidepressant therapy with a 30 day supply or at least 2 claims with a 90 day supply (consecutive defined as \u226415 days gap) \n\n must be continually enrolled during the study timeframe and have both medical and pharmacy benefits \n\n evidence of at least 4 consecutive claims for an atypical antipsychotic prescription with a 30 day supply or 2 claims with a 90 day supply (consecutive defined as \u226415 days gap) \n\n evidence of antidepressant therapy for at least 60 consecutive days prior to the initiation of atypical antipsychotic \n\n After at least a 60 day trial of traditional antidepressant medications, patient augments with an atypical antipsychotic medication for at least 4 months. \n\n ", - "exclusion_criteria": ": \n\n Patients are excluded if they: \n\n have any claims for a diagnosis of schizophrenia, schizoaffective or bipolar disorder during the study period \n\n have Electroconvulsive therapy (ECT) during the study period \n\n new augmentation with mood stabilizers, L-thyroxine (T4), L-Thyronine (T3), buspirone, stimulant, or others during the post-period (table 1) \n\n are pregnant during the study period \n\n patients with Medicare or Medicaid", - "brief_summary": "The primary objective is to examine changes in pre/post-augmentation healthcare costs and resource utilization in patients diagnosed with major depressive disorder (MDD) who augment their current antidepressant therapy with an atypical antipsychotic.", - "NCTID": "NCT01145313" - }, - { - "brief_title": "Girls in Transition Study: Helping Girls Enter the Teenage Years", - "phase": "Phase 1", - "drugs": "['Girls in Transition (GT) program', 'Waitlist Control']", - "drugs_list": [ - "Girls in Transition (GT) program", - "Waitlist Control" - ], - "diseases": "['Depression', 'Anxiety']", - "diseases_list": [ - "Depression", - "Anxiety" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n Female \n\n Student in grades 6 through 8 \n\n Student in participating school \n\n ", - "exclusion_criteria": ": \n\n Male", - "brief_summary": "This is a pilot study of the Girls in Transition (GT) program, an intervention designed to promote resilience and reduce gender-related risk factors for depression. The goal of the study is to gather preliminary data on the effects of the GT program.", - "NCTID": "NCT00641940" - }, - { - "brief_title": "Effects of Sleep Duration on Eating and Activity Behaviors", - "phase": "", - "drugs": "['Increase Sleep', 'Decrease Sleep']", - "drugs_list": [ - "Increase Sleep", - "Decrease Sleep" - ], - "diseases": "['Sleep', 'Obesity']", - "diseases_list": [ - "Sleep", - "Obesity" - ], - "enrollment": "37.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 8-11 years old \n\n BMI for age and gender > 5th percentile (but no greater than 100% overweight) \n\n Sleep approximately 9-10 hours nightly \n\n Attend elementary school \n\n Like at least 1 food and 1 activity used in the reinforcement paradigm \n\n Able to understand and complete the reinforcement paradigm \n\n ", - "exclusion_criteria": ": \n\n Existence of a diagnosable sleep disorder \n\n Medical or psychiatric condition that could influence sleep or weight \n\n Onset of menarche \n\n Inability to complete study materials, including diagnosed disabilities \n\n Dietary restrictions/allergies to foods used in the study that preclude them from study participation", - "brief_summary": "The purpose of the proposed study is to determine whether the amount children sleep is associated with changes in hormones, hunger, motivation to eat, and food intake. Fifty children 8-11 years old who sleep 9-10 hours per night will be enrolled for a 3-week study. For 1 week each, children will be asked to sleep their typical amount, increase their sleep by 1-\u00bd hours, and decrease their sleep by 1-\u00bd hours. Half of the children will be asked to increase their sleep first and half to decrease their sleep first. During each week, the following will be gathered: sleep duration (measured by actigraphy, which is a small device that measures sleep), levels of hormones measured through blood draws, self-reported hunger and appetite, food intake (measured by 3 days of 24-hour recall), how motivated children are to eat (measured using a computer activity), and child height and weight. We believe that when children sleep less they will show changes in hormones associated with hunger and appetite, report being hungrier, be more motivated to eat, and eat more food.", - "NCTID": "NCT01030107" - }, - { - "brief_title": "Application and Evaluation of Group Cognitive Intervention for Depressed Adolescents", - "phase": "Phase 1", - "drugs": "['CBT plus parent education', 'CBT alone']", - "drugs_list": [ - "CBT plus parent education", - "CBT alone" - ], - "diseases": "['Community Adolescents at Risk for Depression and Suicide']", - "diseases_list": [ - "Community Adolescents at Risk for Depression and Suicide" - ], - "enrollment": "31.0", - "inclusion_criteria": "inclusion criteria: \n\n willing to participate group assignment and grant consents \n\n ", - "exclusion_criteria": ": \n\n unwilling to participate potential group activity and grant consents \n\n severe physical or psychiatric disorders", - "brief_summary": "Cognitive behavioral therapy (CBT) is effective and CBT with parental involvement has potential in preventing and treating adolescent depression. The purpose of this study was to compare the short- and long-term effectiveness of CBT alone and CBT plus parental education for community-based adolescents at risk for depression and suicide in Taiwan. It is hypothesized that the CBT alone and CBT with parental education group are more effective than the control group.", - "NCTID": "NCT00946413" - }, - { - "brief_title": "Pilot Study to Evaluate Individualized Choice of Antidepressants in Patients With Cancer", - "phase": "Phase 1", - "drugs": "['Mirtazapine', 'Citalopram']", - "drugs_list": [ - "Mirtazapine", - "Citalopram" - ], - "diseases": "['Major Depressive Disorder', 'Neoplasms']", - "diseases_list": [ - "Major Depressive Disorder", - "Neoplasms" - ], - "enrollment": "21.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosed with a malignancy \n\n Informed consent obtained and signed \n\n Greater than or equal to 18 years of age \n\n Life expectancy determined to be greater than or equal to 6 months \n\n Diagnosed with Major Depressive Disorder based on clinical examination and the DSM-IV-TR criteria \n\n PHQ-9 depression assessment completed by subject, with a score of 10 or greater \n\n Able to take whole or crushed tablets by mouth or by feeding tube \n\n ", - "exclusion_criteria": ": \n\n Unable to complete self-report instruments due to illiteracy, neurologic illness, visual problems, inability to speak or read English, or other causes \n\n Treatment with antidepressants or antipsychotics within the last 3 months \n\n Psychotic or manic behavior \n\n Active suicidal ideation or plan \n\n Current illicit substance abuse \n\n Severe renal impairment as defined by creatinine clearance of <15 milliliters/minute/1.73 meters squared (mL/min/m2) \n\n Severe hepatic impairment as defined by Aspartate Aminotransferase (AST) or alanine aminotransferase (ALT) >5x the upper limit of normal, or a total bilirubin > 3.0 milliliters/deciliter (mL/dL) \n\n History of congenital long QT syndrome \n\n Clinically significant congestive heart failure or bradyarrhythmias \n\n Treatment with a concomitant medication that is known to have a strong association with corrected QT interval (QTc) prolongation AND a QTc >460 for men or >470 for women. Applicable to the citalopram arm only", - "brief_summary": "This is a pilot study to test the hypothesis that the antidepressants mirtazapine and citalopram are effective treatment for major depressive disorder (MDD) in cancer patients.", - "NCTID": "NCT01725048" - }, - { - "brief_title": "Trial of a Sustained Release Methylphenidate in the Treatment of Fatigue in Cancer Patients", - "phase": "Phase 3", - "drugs": "['Methylphenidate', 'Placebo']", - "drugs_list": [ - "Methylphenidate", - "Placebo" - ], - "diseases": "['Breast Cancer', 'Fatigue', 'Gastrointestinal Cancer']", - "diseases_list": [ - "Breast Cancer", - "Fatigue", - "Gastrointestinal Cancer" - ], - "enrollment": "42.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient diagnosed with breast, gastrointestinal, lymphoma, myeloma or lung cancer undergoing chemotherapy or hormonal treatment \n\n Patient is > or = 18 years of age \n\n Patient has Brief Fatigue Inventory fatigue worst score of > or = 4 at baseline \n\n Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of < or = 2 at baseline \n\n Patient has a life expectancy > or = 6 months from the start of the study \n\n Patient is using acceptable birth control methods. Female participants (if of child bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) must use medically acceptable methods of birth control. Medically acceptable methods of contraception include abstinence, birth control pills, diaphragm with spermicide, condom with foam or spermicide, vaginal spermicidal suppository or surgical sterilization \n\n Patient must speak and understand English \n\n Patient has provided written informed consent to participate in the study prior to enrollment to the study \n\n ", - "exclusion_criteria": ": \n\n History of hypersensitivity reaction to methylphenidate \n\n History of or current seizure disorder, glaucoma, major psychiatric diagnosis, narcolepsy, Tourette's syndrome, tension or agitation \n\n History of clinically significant cardiac disease. \n\n Uncontrolled hypertension: has not been on a stable treatment dose for the past month, or has a systolic pressure consistently (defined as 3 consecutive blood pressure readings within the last 30 days) greater than 150 mm Hg or diastolic pressure consistently greater than 85 mm Hg \n\n History of fibromyalgia \n\n Use of alcohol while participating in the study \n\n Current use of illicit drugs or history of alcohol or drug abuse and/or abuse potential (see protocol for criteria) \n\n Moderate to severe depression (> or = 20 on Beck Depression Index II) \n\n If taking antidepressants, no changes in dose and/or no start of new course of treatment in the last 30 days \n\n Currently taking psychostimulants (including appetite suppressants), monoamine oxidase (MAO) inhibitors, anticoagulant or anticonvulsant therapy \n\n Current use of corticosteroids, medications, or stimulants (i.e., vivarin) used to improve fatigue symptoms \n\n Use of an investigational medication within the past month \n\n Current use of the following herbals or supplements for fatigue relief (DHEA, SAME, ginkgo, ginseng, St. John's Wort (including DHEA, SAME, ginkgo, ginseng, St. John's Wort, metabolite, effedrin, basil, citronella, fennel, horseradish roots, lavender flowers, lemon verbena, marjoram, mint, nettle, pine needles, rosemary, sage, savory, thyme, bay, cayenne pepper, cinnamon, eucalyptus, hyssop, myrrh, oregano, peppermint, ginseng, green, black or Chinese tea, ephedra (aka - ma-huang), popotillo, and Mormon tea) \n\n Any coexisting medical condition or are taking any concomitant medication that is likely to interfere with the safe administration of methylphenidate \n\n Patients who start epoetin within 30 days prior to enrollment \n\n Patients who start taking epoetin during the first week of the study \n\n Hemoglobin < 8.0 gm/dl \n\n Patients with a thyroid-stimulating hormone (TSH) value > or = 1.5 times the upper limit of normal (ULN) \n\n Albumin value 50% lower than the lower limit of normal \n\n Evidence of hepatic impairment [total bilirubin > or = 2.5 times ULN (normal range of 0 - 1.0 mg/dl, serum glutamate pyruvate transaminase (SGPT) > or = 2.5 times ULN)] \n\n Evidence of renal impairment (serum creatinine > 2.5 times ULN, normal range of 0.8 - 1.5 mg/dl) \n\n A severe narrowing (pathological or iatrogenic), obstruction of the gastrointestinal tract, or gastrointestinal malabsorption \n\n If taking anxiolytics, and/or hypnotics, no changes in dose and/or no start of new course of treatment in the last 30 days \n\n Patients with nausea, vomiting, or diarrhea of Common Toxicity Criteria for Adverse Effects (CTCAE) grade III or higher \n\n If taking anticonvulsants for sensory neuropathy (Gabapentin or Pregabalin), no changes in dose and/or no start of new course of treatment in the last 30 days \n\n History of severe headaches within 30 days prior to enrollment", - "brief_summary": "The goal of this clinical research study is to see if the drug OROS Methylphenidate HCl (Concerta) can help to control fatigue in patients with breast, gastrointestinal, lymphoma, myeloma or lung cancer who are going through chemotherapy or hormonal treatment or have completed chemotherapy or hormonal treatment in the last 12 months. The safety of this drug will also be studied. Another goal of the study is to see how certain cytokines change while patients undergo chemotherapy or hormonal treatment.", - "NCTID": "NCT00516269" - }, - { - "brief_title": "Erythropoietin in the Prevention of Acute Mountain Sickness", - "phase": "Phase 4", - "drugs": "['Erythropoietin']", - "drugs_list": [ - "Erythropoietin" - ], - "diseases": "['Acute Mountain Sickness']", - "diseases_list": [ - "Acute Mountain Sickness" - ], - "enrollment": "39.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy adults \n\n ", - "exclusion_criteria": ": \n\n History of serious illness \n\n Current smoker or Hemoglobin >15.5gm/dL \n\n Uncontrolled hypertension", - "brief_summary": "Acute mountain sickness (AMS) is a syndrome of nonspecific symptoms and is therefore subjective. The Lake Louise Consensus Group defined acute mountain sickness as the presence of headache in an unacclimatized person who has recently arrived at an altitude above 2,500 m plus the presence of one or more of the following: gastrointestinal symptoms (anorexia, nausea, or vomiting), insomnia, dizziness, and lassitude or fatigue. An increase in RBC mass is a natural feature of altitude acclimatization. Hypoxia-induced erythropoietin (EPO) secretion begins hours after ascent and stimulates bone marrow production of red blood cells, but this takes weeks to effect an increase in red cell mass . Therefore, it is feasible that EPO therapy weeks before altitude exposure decrease high altitude illness.~In 1996, Young et al in U.S. Army Research Institute of Environmental Medicine (USARIEM) reported that autologous erythrocyte infusion did not ameliorate the decrement in maximal oxygen uptake at 4,300m altitude despite increasing arterial oxygen carrying capacity. On the basis of this report, USARIEM did not recommend use of recombinant EPO for altitude acclimatization.~However, increases in erythrocyte count, hematocrit and hemoglobin associated with EPO therapy have been shown to decrease fatigue and increase work capacity and exercise tolerance. In addition, improvement in CNS function and cognitive ability has been noted with EPO therapy. Subjective benefits include improvement in sleep habits, tolerance to cold; decreased dyspnea, anginal symptoms and tachycardia and improved appetite, all of which are symptoms associated with high altitude illness.~The investigators also reported improved muscle energy metabolism with EPO in dialysis patients, but not with RBC transfusion.~In this study, the investigators will conduct a randomised controlled trial to assess the effect of EPO administration on AMS at an altitude of 4,130 m.", - "NCTID": "NCT01665781" - }, - { - "brief_title": "Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients", - "phase": "Phase 3", - "drugs": "['Testosterone', 'Placebo']", - "drugs_list": [ - "Testosterone", - "Placebo" - ], - "diseases": "['Advanced Cancer']", - "diseases_list": [ - "Advanced Cancer" - ], - "enrollment": "53.0", - "inclusion_criteria": "inclusion criteria: \n\n Male patients with any advanced cancer (metastatic or locally recurrent) who have a bioavailable testosterone (BT) of < 70 ng/dL. \n\n Male patients who have fatigue present every day for the last two weeks and have an Edmonton Symptom Assessment System (ESAS) fatigue score during the last 24 hours of >/= to 4 on a 0 to 10 scale (in which 0 = no fatigue and 10 = worst possible fatigue). \n\n Male patients who are willing to receive intramuscular injections every 2 weeks and are 18 years of age or older are eligible for this study. \n\n Participants must be willing to have blood samples drawn at screening and/or baseline and every two weeks until the end of treatment. \n\n Prostatic Specific Antigen (PSA) level must be lower than 4.0 ng/mL to be eligible for this study and Digital Rectal Exam (DRE) must be normal. \n\n Eastern Cooperative Oncology Group (ECOG) PS /= 9 g/dL. If the patient has not had blood drawn for a hemoglobin level in the past 28 days, one will be done to determine eligibility. Patients with a hemoglobin < 9 g/dL will be referred for treatment of their anemia. \n\n ", - "exclusion_criteria": ": \n\n Patients who are determined incapable of completing questionnaires due to cognitive or physical deficits are ineligible for this study \n\n Abnormal Digital Rectal Exam (DRE) at baseline or history of severe untreated benign prostatic hypertrophy (BPH) with International Prostatic Symptom Score (IPSS) >19. \n\n Patients with a history of prostate cancer, a history of breast cancer or adenocarcinoma of unknown origin. \n\n A history of untreated obstructive sleep apnea. \n\n Uncontrolled severe heart failure (NYHA Class III or IV), uncontrolled cardiac arrhythmia or severe chronic obstructive pulmonary disease (COPD) requiring home oxygen. \n\n Patients who have evidence of pre-existing hypopituitarism/hypogonadism including status post bilateral orchiectomy, for which replacement therapy is mandated, are ineligible for this study. \n\n Patients exhibiting clinically diagnosed severe dehydration are ineligible. \n\n Patients with a history of uncontrolled arrhythmia. \n\n Patients who are currently receiving androgen therapy or dehydroepiandrosterone (DHEA) \n\n Diabetics with a history of frequent episodes of hypoglycemia or uncontrolled diabetes mellitus (DM) defined as a fasting glucose over 200 mg/dL or HbA1c above 8%. \n\n Uncontrolled thyroid disease \n\n Hypercalcemia (corrected calcium > 10.5 g/dL); estimated glomerular filtration rate < 60 mg/min using the Modification of Diet in Renal Disease glomerular filtration rate (MDRD GFR); ALT > 3x the upper limit of normal (UNL) \n\n Patients on warfarin, cyclosporine, dong quai, eucalyptus, dicumarol, germander, Jin bu huan, kava, pennyroyal, chaparral, comfrey, phenprocoumon are ineligible for this study. \n\n Unstable symptoms could contribute to fatigue such as severe pain (score> 6 on ESAS) or severe depression (defined as a score of 15 or greater on the Depression Subscale of the Hospital Anxiety Depression Scale [HADS]). These symptoms should be resolved or stable for >/= 2 weeks at baseline for inclusion into study. \n\n Patients with hematocrit (Hct) > upper normal limits (UNL) will be excluded due to possible polycythemia. If the patient has not had blood drawn for a hematocrit level in the past 28 days, one will be performed at baseline to determine eligibility. \n\n Patients who have a known sensitivity to sesame seed products.", - "brief_summary": "The goal of this clinical research study is to learn if and how testosterone replacement therapy may affect fatigue in males with advanced cancer and low testosterone levels.", - "NCTID": "NCT00965341" - }, - { - "brief_title": "Pexacerfont for Stress-induced Food Craving", - "phase": "Phase 1", - "drugs": "['Pexacerfont']", - "drugs_list": [ - "Pexacerfont" - ], - "diseases": "['Daily Oral Pexacerfont for 28 Days (300 mg/Day Loading Dose for 7 Days, Followed', 'Placebo']", - "diseases_list": [ - "Daily Oral Pexacerfont for 28 Days (300 mg/Day Loading Dose for 7 Days", - "Followed", - "Placebo" - ], - "enrollment": "31.0", - "inclusion_criteria": "inclusion criteria: \n\n Body Mass Index (BMI) > 22 kg/m(2) \n\n Score of 15 or higher on the Dietary Restraint Scale, with endorsement of the Restraint \n\n Scale item Do you give too much time and thought to food? \n\n Age 21 - 65 years. \n\n (4a) For women of childbearing potential: must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study drug, and agree to use an adequate method of contraception to avoid pregnancy for a period of 6 months beginning from first dose of randomized treatment. Women of childbearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Adequate methods of contraception for sexually active women are having a male sexual partner(s) who is surgically sterilized prior to inclusion; having a sexual partner(s) who is/are exclusively female; using oral contraceptives (either combined or progesterone only) with a single-barrier method of contraception consisting of spermicide and condom or diaphragm; using double-barrier contraception, specifically, a condom plus spermicide and a female diaphragm or cervical cap; or using an approved intrauterine device (IUD) with established efficacy. \n\n (4b) Men, unless surgically sterilized (vasectomy with documentation of azoospermia), must agree to practice abstinence or use barrier contraception, and not donate sperm, for a period of 6 months beginning from first dose of randomized treatment. \n\n ", - "exclusion_criteria": ": \n\n Current employment at NIDA IRP or Bristol-Myers Squibb (BMS), or being in the immediate family of an employee. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. \n\n Current participation in another clinical study that includes exposure to an investigational or non-investigational drug or device. \n\n Participation in a clinical study for a condition related to weight or dieting within the preceding month. \n\n Any history of participation in a trial involving pexacerfont or closely related compounds. \n\n Any medical condition or laboratory finding that, in the judgment of the investigators, could adversely affect safety or study integrity. Examples include but are not limited to diabetes type 1 and type 2, ischemic heart disease, uncontrolled hypertension, and history of cerebrovascular accident or transient ischemic attack. \n\n For women: pregnancy, breastfeeding, or planning to become pregnant within 6 months from the administration of first dose of study drug. \n\n Past or present diagnosis of any eating disorder, including Anorexia Nervosa, Bulimia Nervosa, and Eating Disorder NOS (e.g., Binge-Eating Disorder). (Eating-disordered individuals probably represent a distinct population and should therefore be studied separately.) \n\n Past or present diagnosis of schizophrenia, bipolar disease, or any psychotic disorder; past or present diagnosis of dementia or any other disorder that has led to a clinically significant cognitive impairment; present diagnosis of any mood or anxiety disorder; any other psychiatric condition that presently requires, or in the past month has required, pharmacological intervention. \n\n Past or present diagnosis of any substance-use disorder except nicotine dependence. \n\n Urine tests positive for illegal drugs. \n\n Evidence of thyroid disorder by medical history or screening physical exam, with TSH < 0.36 or greater than 3.74 UIU/ml; or current or history of use of thyroid medication. \n\n Adrenal or pituitary pathology as evidenced by medical history or suggested by abnormal screening labs. \n\n Current seizure disorder or a significant history (as judged by the investigators) of a seizure disorder, other significant neurological disorders (e.g., Parkinson's Disease, multiple sclerosis, stroke, neurodegenerative disease, cerebral palsy) or severe head trauma (including closed head trauma, penetrating head injury, skull fracture, or intracranial hemorrhage), or CNS tumor. \n\n Active liver disease or a history of hepatic intolerance to medications that, in the investigators' judgment, is medically significant. \n\n History of diabetes mellitus type I and II or gastric bypass or reduction surgery. \n\n Justification: illnesses that change metabolism or the absorption from the GI tract, would interfere with drug metabolism or absorption). \n\n Difficulty swallowing tablets or capsules. \n\n Exclusionary physical and laboratory test findings: \n\n QTc > 475 msec \n\n platelets less than or equal to 75,000/mm(3) \n\n hemoglobin less than or equal to 9g/dL \n\n neutrophils, absolute less than or equal to 1000/mm3 \n\n SGOT (AST) > 2.5 times upper limit of normal \n\n SGPT (ALT) > 2.5 times upper limit of normal \n\n bilirubin 2 times upper limit of normal \n\n GFR < 60mL/min/1.73m2 or significant proteinuria \n\n diastolic blood pressure > 105 mmHg \n\n TSH < 0.36 or > 3.74 UIU/ml \n\n Current use or history of use in the last 3 months of psychiatric medications, including but not limited to antidepressants, lithium, antipsychotics, anxiolytics, antiepileptics, opiates, or hypnotics. \n\n Any change in a non-excluded medication in the past 3 months. \n\n Systemic intake of corticosteroids acutely within 2 weeks or chronically (> 28 days) within the last 6 months. (Topical hydrocortisone and inhaled corticosteroids are allowed.) \n\n Use of medications that are CYP3A4 inhibitors or inducers (see Appendix 3); study applicants should not take these medications for at least 7 days prior to randomization and during the remainder of the study. \n\n Dietary restrictions or food aversions that would interfere with valid assessment of eating in our laboratory sessions.", - "brief_summary": "Background:~- Stress can cause people to give in to temptations to eat less healthily. People who are on weight loss diets often have problems sticking to their diets when they are stressed. Some tests have shown that the drug pexacerfont can help reduce stress-related seeking of high-calorie foods. However, it has not been tested on reducing food craving. Researchers want to test pexacerfont on people who are on diets to see if it can reduce stress-related food cravings.~Objectives:~- To see if pexacerfont can help reduce stress-induced food cravings.~Eligibility:~- Individuals between 21 and 65 years of age who are on a diet to control their weight.~Design:~Participants will be screened with a physical exam and medical history. This study requires seven visits over about 35 days.~Participants will take either pexacerfont or placebo pills during the study. They will have three pills every morning. They will record video of themselves taking the pills every day.~Every evening, participants will fill out a questionnaire. It will ask questions about feelings and behaviors related to eating and food craving.~Participants will have regular study visits while taking the pills. The visits will involve questions about stressful situations and food cravings. One visit will involve a mildly stressful math test, followed by tasting of different foods. This test will look at whether pexacerfont can affect food preferences. Participants will provide blood and saliva samples as directed at these study visits.~Participants will have follow-up phone calls 1, 3, and 6 months after the end of the study.", - "NCTID": "NCT01656577" - }, - { - "brief_title": "The Flamenco (Fitness League Against MENopause COsts) Project", - "phase": "", - "drugs": "['exercise']", - "drugs_list": [ - "exercise" - ], - "diseases": "['Quality of Life', 'Cardiovascular Diseases', 'Diabetes', 'Dyslipidemias', 'Metabolic Syndrome']", - "diseases_list": [ - "Quality of Life", - "Cardiovascular Diseases", - "Diabetes", - "Dyslipidemias", - "Metabolic Syndrome" - ], - "enrollment": "160.0", - "inclusion_criteria": "inclusion criteria: \n\n Age: 45-60 years. \n\n Not to have other severe somatic or psychiatric disorders, or other diseases that prevent physical loading (Answer no to all questions on the Physical Activity Readiness Questionnaire-PAR-Q) . \n\n Not to be engaged in regular physical activity >20 min on >3 days/week. \n\n Able to ambulate, with or without assistance. \n\n Able to communicate. \n\n Informed consent: Must be capable and willing to provide consent. \n\n ", - "exclusion_criteria": ": \n\n Acute or terminal illness. \n\n Myocardial infarction in the past 3 months. \n\n Not capable to ambulate. \n\n Unstable cardiovascular disease or other medical condition. \n\n Upper or lower extremity fracture in the past 3 months. \n\n Severe dementia (MMSE < 10). \n\n Unwillingness to either complete the study requirements or to be randomised into control or training group. \n\n Presence of neuromuscular disease or drugs affecting neuromuscular function.", - "brief_summary": "Spain is the second country in the world that consume more drugs. The average drug expenditure per capita in Andaluc\u00eda during 2011 was 219.2 \u20ac. This drug spending increases during the perimenopausal period. According to the Study of the Economic Impact of Sport on Health Spending of the Ministry of Health of the Generalitat of Catalonia, for every euro invested in sports promotion 50 euros are saved in health spending accumulated over 15 years. The main objectives of this project are: i) To analyze the (cost-effectiveness) effect of an exercise program on the prescription of drugs in a sample of Andalusian women aged 45-60 years. ii ) To study the level of physical activity and sedentarism (measured objectively by accelerometry ) , functional capacity , quality of life and clinical profile of this population. iii ) To analyze the relationship between levels of physical activity / sedentarism and pharmaceutical expenditure. In the present project, an exercise program aimed at minimizing symptoms and health problems associated with the perimenopausal period will be performed (Dyslipidemia, diabetes, anxiety, depression, quality of life, quality of sleep, obesity, osteoporosis and cardiovascular disease). A total of 160 perimenopausal women will be randomly assigned to the intervention group exercise (n = 80 ) or to the usual care group (n = 80). Participants in the intervention group will train 3 days / week ( 60 min per session ) for 16 weeks.~With the analysis of the results of this project new patterns of objective work as well as the most significant practical resources for the design of a master plan may be determined. Results are expected to be able to shed some light on the implementation of programs of health promotion that are both time beneficial for the Andalusian Public Health and for the family , institutional and community economy.", - "NCTID": "NCT02358109" - }, - { - "brief_title": "Mechanism of tDCS-induced Learning Enhancement - the Role of Serotonin", - "phase": "Phase 1", - "drugs": "['tDCS', 'Citalopram', 'sham-tDCS + placebo']", - "drugs_list": [ - "tDCS", - "Citalopram", - "sham-tDCS + placebo" - ], - "diseases": "['Healthy Young and Older Adults']", - "diseases_list": [ - "Healthy Young and Older Adults" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n right handedness \n\n unobtrusive neuropsychological screening \n\n ability to provide written informed consent \n\n no pathological findings in head MRI \n\n age: 18 to 35 years (young adults) or 50-80 years (older adults) \n\n Highly effective contraception (Pearl Index < 1) or reliable abstinence from any heterosexual relationships in women of childbearing potential \n\n ", - "exclusion_criteria": ": \n\n severe internal or psychiatric disease (especially depression or suicidal thoughts) \n\n epilepsy \n\n cognitive impairment (< SD under age adjusted norm in neuropsychological testing) \n\n concurrent taking of serotonin precursors (tryptophan, 5-HTP) or MAO inhibitors \n\n concurrent taking of tramadol or triptans \n\n concurrent taking of pimozide or linezolid \n\n concurrent taking of other drugs prolonging the QT-interval \n\n long-QT-syndrome \n\n hypokalemia or hypomagnesemia \n\n known intolerance of the study medication \n\n claustrophobia or metallic implants, tattoos (MRI ", - "brief_summary": "The aim of this study is to assess whether the application of a selective serotonin reuptake inhibitor (SSRI) enhances and prolongs the learning enhancement achieved by anodal transcranial direct current stimulation (atDCS). For this, young and older healthy subjects will be tested with a well established learning paradigm. Results of this study may help to support the application of atDCS also in patients, e.g. with dementia or mild cognitive impairment.", - "NCTID": "NCT02092974" - }, - { - "brief_title": "Pathways Linking Reduced Sleep Duration and Quality to Obesity Risk", - "phase": "", - "drugs": "['Baseline', 'Sleep restriction', 'Reduced Sleep Quality']", - "drugs_list": [ - "Baseline", - "Sleep restriction", - "Reduced Sleep Quality" - ], - "diseases": "['Obesity', 'Diabetes']", - "diseases_list": [ - "Obesity", - "Diabetes" - ], - "enrollment": "23.0", - "inclusion_criteria": "inclusion criteria: \n\n Normal weight \n\n Healthy \n\n Normal sleep times \n\n ", - "exclusion_criteria": ": \n\n Sleep disorders \n\n Overweight \n\n Diabetes \n\n Other health conditions \n\n Excessive caffeine and alcohol intake \n\n Smoking", - "brief_summary": "This study is designed to study the pathways through which short sleep duration or poor sleep quality can lead to an increased risk of developing diabetes and obesity.", - "NCTID": "NCT00915707" - }, - { - "brief_title": "Quetiapine Augmentation Versus Clomipramine Augmentation of SSRI for Obsessive-compulsive Disorder Patients", - "phase": "Phase 4", - "drugs": "['Quetiapine', 'Clomipramine']", - "drugs_list": [ - "Quetiapine", - "Clomipramine" - ], - "diseases": "['Obsessive Compulsive Disorder']", - "diseases_list": [ - "Obsessive Compulsive Disorder" - ], - "enrollment": "21.0", - "inclusion_criteria": "inclusion criteria: \n\n primary OCD diagnosis according to DSM IV criteria \n\n current symptoms were responsible for significant distress \n\n previous trial of at least 12 weeks with SSRI (being at least 8 weeks at maximum tolerated dosage) failed to produce full remission of OCD symptoms \n\n ", - "exclusion_criteria": ": \n\n presence of clinical or neurological diseases that may be worsen by the medications included in treatment protocol \n\n current substance dependence or abuse, \n\n current psychotic symptoms \n\n current suicide risk \n\n and current pregnancy or intention to get pregnant before the end of the treatment protocol", - "brief_summary": "The objective of this trial is to compare in an open trial format the efficacy of association of clomipramine and quetiapine with SSRI after SSRI treatment failed to produce complete remission of obsessive compulsive disorder symptoms.", - "NCTID": "NCT00564564" - }, - { - "brief_title": "Mindfulness and Acceptance Applied in Colleges Through Web-Based Guided Self-Help", - "phase": "Phase 1", - "drugs": "['Web-Based Guided Self-Help']", - "drugs_list": [ - "Web-Based Guided Self-Help" - ], - "diseases": "['College Student Mental Health']", - "diseases_list": [ - "College Student Mental Health" - ], - "enrollment": "113.0", - "inclusion_criteria": "inclusion criteria for Counselors: \n\n Currently working at a College Counseling Center \n\n Willingness to take the ACT guided self-help training through the counselor portal until reaching a passing criterion of 80% \n\n Willingness to distribute flyers about the study to five students, in an attempt to recruit 3 clients to participate in the self-help modules \n\n ", - "exclusion_criteria": " for Counselors: \n\n Prior participation in this study \n\n inclusion criteria for Student Clients: \n\n Currently being treated at a College Counseling Center \n\n Willingness to participate in three half-hour modules as part of a web-based guided self-help program and complete pre and post assessments across a period of 4 weeks \n\n Referred to the study/self-help modules by counselor \n\n Participation will comply with targeted enrollment plans, and attention will be paid to selecting an ethnically/racially diverse group \n\n Student is clinically stable as per counselor judgment (e.g., not actively suicidal, psychotic, or disruptive) \n\n ", - "brief_summary": "College counseling centers (CCCs) are being faced with increasing demands for services to meet the treatment needs of their students, in the context of increasingly severe cases and declining resources. Innovative, cost effective solutions are needed.~The proposed project seeks to meet these needs by testing a web-based guided self-help version of Acceptance and Commitment Therapy (ACT), an evidence-based transdiagnostic therapy found to effectively treat a range of psychological problems. An ACT program would provide a means of implementing effective treatment for the range of problems in the CCC setting, while the guided self-help format would reduce counselors' workload, improving cost-effectiveness and reducing waiting lists. This would both treat students and train counselors in how to implement the ACT intervention. Three self-help lessons have been developed, as well as a counselor portal to review students' use of the program and to receive training on implementing ACT guided self-help.~The study is a pre-post, open(i.e., non-randomized) feasibility trial with 20 counselors and 60 clients from multiple CCCs throughout the country.", - "NCTID": "NCT01808404" - }, - { - "brief_title": "Double Blinded, Placebo-Controlled Trial of Paliperidone Addition in SRI-Resistant Obsessive-Compulsive Disorder", - "phase": "Phase 2", - "drugs": "['Paliperidone', 'Placebo']", - "drugs_list": [ - "Paliperidone", - "Placebo" - ], - "diseases": "['Obsessive-Compulsive Disorder']", - "diseases_list": [ - "Obsessive-Compulsive Disorder" - ], - "enrollment": "34.0", - "inclusion_criteria": "inclusion criteria: \n\n Meets DSM-IV-TR criteria for a principal current diagnosis of OCD which is confirmed by both clinical evaluation and by structured interviews. OCD subjects with other comorbidities will be included provided OCD is judged to be the chief complaint. \n\n Subjects must continue to experience clinically significant symptoms of OCD (Y-BOCS score \u226519 and a rating of moderate or greater on the Clinical Global Impressions (CGI) scale) despite at least two adequate SRI monotherapy trials. One unsatisfactory trial can include the SRI currently being taken by the patient provided that the duration of treatment is 12 weeks or more and that the dose has been adequate. Subjects must be taking a clinically effective dose of a SRI (i.e., clomipramine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline) for at least 12 weeks. Subjects must be on their current dose for at least 12 weeks and must maintain their current dose throughout the study. \n\n Between the ages of 18-70 years of age. \n\n Only subjects with OC symptoms of at least one-year duration will be included. \n\n Eligible subjects must be in good physical health. Screening procedures will include detailed medical history, complete physical and neurological exams, routine blood studies (CBC, liver function tests, electrolytes), ECG, urine toxicology screen, and serum pregnancy test in women of child-bearing potential. \n\n ", - "exclusion_criteria": ": \n\n Primary depression, schizophrenia or other psychotic disorders. \n\n Active bipolar disorder. \n\n Non-responder in the past to atypical antipsychotic augmentation. This criterion was chosen to prevent recruiting a sample of chronically refractory OCD cases that would otherwise be suited for more extreme interventions such as deep brain stimulation. \n\n Non-responder in the past to an adequate trial (> 20 hours) of cognitive-behavioral therapy that will be assessed by records review. \n\n Current clinically significant suicidality or individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical intervention. \n\n Alcohol or other significant substance abuse within the last 6 months. \n\n History of neurosurgery, encephalitis or significant head trauma or a significant medical condition such as heart, liver, or renal disease. \n\n Nursing mothers or women of childbearing potential who do not use adequate contraception will be excluded. \n\n Subjects at an increased risk for seizures will also be excluded from this study (e.g., subjects with a history of seizures [other than childhood febrile seizures], subjects taking concomitant medications known to lower the seizure threshold). \n\n Estimated IQ < 80, mental retardation, dementia, brain damage, or other cognitive impairment that would interfere with the capacity to participate in the study and complete measures. If needed, the WASI will be used to assess this at screening. \n\n Concurrent use of benzodiazepines, other than for treatment of insomnia, will be prohibited during the trial. No other psychotropic medications will be permitted.", - "brief_summary": "Obsessive-compulsive disorder (OCD) is a common, chronic, and oftentimes disabling disorder. The only established treatments for OCD are a specific form of Cognitive Behavioral Therapy (CBT) and the Serotonin Reuptake Inhibitor medications (SRIs). Few patients with OCD experience complete symptom resolution with either modality and even after two consecutive SRI trials, as many as 30%-40% of patients fail to derive a satisfactory response. Pharmacological options for these SRI-resistant cases include switching to a different antidepressant, increasing the dose of SRI, or augmentation with another agent.~Previous studies showed that approximately 33-50% of OCD patients who have not had an adequate response to SRI medication had a positive response when an atypical antipsychotic medication was added. However, the problematic acute and long-term side effects of these medications are of concern and, at times, limit their use. Paliperidone has a number of advantages over these medications including fewer drug interactions and better tolerability. Thus, this study is designed to determine whether paliperidone augmentation of an existing medication is effective relative to taking a placebo and your existing medication.", - "NCTID": "NCT00632229" - }, - { - "brief_title": "To Determine if Sleep Deprivation Results in Increased Esophageal Acid Exposure", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Gastroesophageal Disease']", - "diseases_list": [ - "Gastroesophageal Disease" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Male/Female - 18-80 \n\n 2 or more episodes of heartburn a week for last 3 months \n\n ", - "exclusion_criteria": ": \n\n Previous upper GI surgery \n\n Underlying co-morbidity \n\n Narcotic medications \n\n Psychotropic's and Benzodiazapines medications \n\n Hx of psychological abnormalities \n\n Hx of ETOH in previous 6 mos. \n\n Diabetes Mellitus \n\n Neuropathy \n\n Seizures \n\n Sleep Apnea \n\n Co-morbidity that interfere w/sleep \n\n Women who are pregnant, or childbearing yrs, not on BC", - "brief_summary": "The purpose of this study is to determine if sleep deprivation results in increased esophageal acid exposure in healthy controls and gastroesophageal reflux disease (GERD) patients.", - "NCTID": "NCT01093339" - }, - { - "brief_title": "Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia", - "phase": "Phase 2", - "drugs": "['armodafinil', 'placebo', 'armodafinil', 'armodafinil']", - "drugs_list": [ - "armodafinil", - "placebo", - "armodafinil", - "armodafinil" - ], - "diseases": "['Schizophrenia']", - "diseases_list": [ - "Schizophrenia" - ], - "enrollment": "287.0", - "inclusion_criteria": "Key inclusion criteria: \n\n The patient has a diagnosis of schizophrenia according to the DSM-IV-TR criteria and the patient has been clinically stable in a nonacute phase of their illness. \n\n Documentation that the patient has received treatment with olanzapine, oral risperidone, or paliperidone for schizophrenia for at least 6 weeks prior to the screening visit and has been on a stable dose of that antipsychotic medication for at least 4 weeks prior to the screening visit. \n\n The patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator. \n\n Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or documented abstinence. \n\n The patient has a PANSS negative symptom score of 15 or more at the screening and baseline visits. \n\n Key ", - "exclusion_criteria": ": \n\n The patient has a severity rating of moderate or worse on any item of the PANSS positive symptom subscale. \n\n The patient has any Axis I disorder according to DSM-IV-TR criteria, including schizoaffective disorder, apart from schizophrenia and nicotine dependence, or any Axis II disorder that would interfere with the conduct of the study. \n\n The patient has moderate to severe depressive symptoms, as indicated by the CDSS. \n\n The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present. \n\n The patient has tardive dyskinesia, akathisia, moderate or worse level of extrapyramidal symptoms, or any other clinically significant movement disorder. \n\n The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or has a history of multiple clinically relevant allergies. \n\n The patient is a pregnant or lactating woman. \n\n The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.", - "brief_summary": "The primary objective of the study is to evaluate whether armodafinil treatment is more effective than placebo as adjunctive therapy to antipsychotic medication in alleviating the negative symptoms of schizophrenia", - "NCTID": "NCT00772005" - }, - { - "brief_title": "Exercise Behavior Among Young Adults Study", - "phase": "", - "drugs": "['Exercise info', 'Implementation intentions', 'Industriousness', 'pedometer']", - "drugs_list": [ - "Exercise info", - "Implementation intentions", - "Industriousness", - "pedometer" - ], - "diseases": "['Physical Activity']", - "diseases_list": [ - "Physical Activity" - ], - "enrollment": "221.0", - "inclusion_criteria": "inclusion criteria: \n\n be currently enrolled in full-time university coursework \n\n be between 18 and 24 years old \n\n understand and respond to screening questions in English \n\n be able to read at a Grade 6 level \n\n have adequate health, as assessed by having a body mass index between 18.5 and 29.9 (anyone with a BMI of 30+ is considered obese; National Heart, Lung, & Blood Institute, 2012) to ensure that regular, moderate to intense exercise activity will not negatively affect health \n\n identify as individuals who have tried to initiate and continue an exercise regimen sometime in the past but have been unable to maintain the activity \n\n indicate the desire to initiate physical activity at the current time \n\n be willing to attempt to maintain an exercise schedule during the three-week intervention period to which they will be randomly assigned \n\n be willing to participate in the 2-month and 6-month follow up periods \n\n ", - "exclusion_criteria": ": \n\n not already be meeting current USDHHS physical activity recommendations (i.e., at least 150 minutes of moderate-intensity exercise per week) \n\n not have major cognitive impairments (i.e., assessed by whether they can understand and respond adequately to all screening questions) \n\n not report consuming more than three (women) or four (men) alcoholic drinks per day (as this may interfere with their ability to engage in physical activity and confound study results) \n\n not be pregnant \n\n not have children \n\n not have preexisting physical limitations or recent injuries \n\n not have major cognitive impairments (i.e., assessed by whether they can understand and respond adequately to all screening questions)", - "brief_summary": "The rate of adult obesity in the United States has increased more than two times since 1970, and the rate of child-teen obesity has increased by four times. One of the antecedents of obesity is an inactive lifestyle. Exercise has been known to be associated with increases in both physical and mental health by increasing longevity, preventing risk of obesity, coronary heart disease, and hypertension, and increasing self-esteem and overall quality of life. The broad aim of the current study is to investigate the effectiveness of psychoeducational training to increase exercise activity initiation and maintenance in young adults.~The goal of this study is to compare three training approaches for college students to increase exercise behavior. One approach provides general information on the different types of exercises and benefits of engaging in exercise behavior after an initial questionnaire assessment session. A second approach includes the general exercise information and questionnaire assessment as well as training on how to create specific goal intentions (i.e., implementation intentions) to aid in exercise initiation. A third approach uses all the components of the second approach but also tests the utility of a personality-informed module by incorporating concepts from the theory of learned industriousness. It is expected that the third approach will be the most effective in helping participants initiate and maintain their exercise activities during the course of the study duration.", - "NCTID": "NCT02204176" - } - ], - "1": [ - { - "brief_title": "Brief Group Intervention Using EFT (Emotional Freedom Techniques) for Depression in College Students", - "phase": "Phase 1", - "drugs": "['EFT (Emotional Freedom Techniques)']", - "drugs_list": [ - "EFT (Emotional Freedom Techniques)" - ], - "diseases": "['Depression']", - "diseases_list": [ - "Depression" - ], - "enrollment": "70.0", - "inclusion_criteria": "inclusion criteria: \n\n A score of 19 or more on the Beck Depression Inventory \n\n Currently enrolled at the University of Santo Tomas \n\n Able to read, understand, and complete forms \n\n ", - "exclusion_criteria": ": \n\n None", - "brief_summary": "Depression is an important mental health concern in college students. This study will recruit students who test positive for moderate to severe depression on the Beck Depression Inventory (BDI). Subjects will be randomly assigned to either a treatment or a control condition. Those in the treatment group will receive four 90 minute group classes using EFT (Emotional Freedom Techniques) to address traumatic memories and other self-identified causes of depression. It will compare them to a no treatment control group.", - "NCTID": "NCT01117532" - }, - { - "brief_title": "Event Related Potentials in Borderline Personality Disorder and Major Depression", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Borderline Personality Disorder', 'Major Depression']", - "diseases_list": [ - "Borderline Personality Disorder", - "Major Depression" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n age between 18 and 45 \n\n female \n\n noncontrols diagnosis: major depression &/or borderline personality disorder \n\n Control participants should have neither major depression or borderline pers. \n\n meet Structured Controlled Interview for DSM - II cut off scores \n\n meet Beck Depression Inventory (BDI)cut off scores \n\n meet Borderline Evaluation of Severity Over Time(BEST) cut off scores. \n\n ", - "exclusion_criteria": ": \n\n based on having none of the below diagnoses from patient history, prior clinical records and based on MINI Plus International Neuropsychiatry Interview \n\n schizophrenia \n\n psychosis \n\n Attention Deficit Hyperactivity Disorder \n\n Obsessive Compulsive Disorder \n\n bipolar disorder \n\n mental retardation \n\n dementia \n\n CNS disease \n\n Post-Traumatic Stress Disorder in non-borderline personality disorder groups \n\n Recreational drug or alcohol use in the past week.", - "brief_summary": "This study examines whether depression in people with borderline personality disorder is different than depression in people without borderline personality disorder.~Unlike people who have depression alone (i.e. without borderline personality disorder), people with borderline personality disorder have depressions that often do not improve with medications. This makes treating depression much more challenging in someone with borderline personality disorder than without borderline personality disorder.~Borderline personality disorderis associated with difficulty in understanding and communicating feelings. Impaired emotion processing may reflect dysfunction of an area of the brain, the anterior cingulate.~Depression is associated with changes in anterior cingulate activity. The investigators believe that when borderline personality disorder is present with depression, brain activity changes in the anterior cingulate will not be the same as in depressed patients without borderline personality disorder.~An electroencephalogram records brain electrical activity. In this study, the investigators will measure electroencephalogram indices reflecting anterior cingulate activity.~HYPOTHESIS: In this study, the investigators predict that when borderline personality is present with depression, electroencephalogram indices of anterior cingulate activity will be different from when depression is present alone (without borderline personality). This could help to explain why people with borderline personality have depressions that are harder to treat than depressions in people without borderline personality.~The investigators also predict that electroencephalogram indices of the anterior cingulate will reflect emotional processing ability, as measured by validated questionnaires.", - "NCTID": "NCT01469663" - }, - { - "brief_title": "Effect of Ketamine vs. Active Placebo on Suicidal Ideation in Depressed Inpatients With Major Depressive Disorder or Bipolar Depression.", - "phase": "Phase 1", - "drugs": "['Ketamine', 'Midazolam', 'Treatment as usual (TAU)']", - "drugs_list": [ - "Ketamine", - "Midazolam", - "Treatment as usual (TAU)" - ], - "diseases": "['Major Depressive Disorder', 'Bipolar I Disorder', 'Bipolar II Disorder', 'Bipolar Depression', 'Suicidal Ideation']", - "diseases_list": [ - "Major Depressive Disorder", - "Bipolar I Disorder", - "Bipolar II Disorder", - "Bipolar Depression", - "Suicidal Ideation" - ], - "enrollment": "9.0", - "inclusion_criteria": "inclusion criteria: \n\n Provision of written informed consent \n\n [MDD stream only] Diagnosis of major depressive disorder, currently depressed as determined by DSM-IV diagnostic criteria (confirmed using the MINI) \n\n [BD stream only] Diagnosis of bipolar disorder, type I or type II, currently depressed as determined by DSM-IV diagnostic criteria (confirmed using the MINI) \n\n Both females and males, aged 18 to 65 years \n\n Inpatient status \n\n Female patients of childbearing potential must have a negative urine human chorionic gonadotropin (hCG) test at enrolment and must be taking or willing to take some acceptable form of birth control during the course of the study if they are or plan to be sexually active \n\n The ability to understand and comply with the requirements of the study and capable of providing informed consent \n\n Suffering from suicidal ideation/attempts as evidenced by a score of >0 on either of the SSI or CSSRS or both. \n\n ", - "exclusion_criteria": ": \n\n Current or past psychotic symptoms \n\n Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria \n\n Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrollment \n\n Any pervasive developmental disorder (according to DSM-IV criteria) \n\n Diagnosis of dementia (according to DSM-IV criteria) \n\n Known intolerance or hypersensitivity to ketamine or midazolam as judged by the investigator \n\n Significant medical condition that would contraindicate the use of ketamine, midazolam or that is untreated and would need urgent attention (as determined by treating physician) \n\n Medical conditions that would significantly affect absorption, distribution, metabolism, or excretion of ketamine or midazolam \n\n Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator \n\n Any clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator \n\n Pregnancy (or female of child-bearing age not using adequate contraception) or lactation \n\n A positive \u03b2-hCG test at enrollment \n\n Involvement in the planning and conduct of the study \n\n Previous enrollment or randomisation of treatment in the present study \n\n Participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements", - "brief_summary": "Depression and suicidal ideation/attempt/death are major causes of morbidity and mortality from psychiatric illnesses. In 2009, the World Health Organization listed depression as the leading cause of years lost due to disability worldwide. Suicide is the 9th most common cause of death in Canada with 1.6% of Canadians ultimately dying from suicide (Statistics Canada, 2012) and the 2nd most common cause of death in young people after accidental deaths. This information highlights the importance of finding treatments to prevent suicidal deaths.~Ketamine has been shown to provide rapid treatment response for major depressive episodes both in major depressive disorder (MDD) and bipolar disorder (BD), via a single intravenous infusion which persists for at least 72 hours.~The purpose of this study is to conduct a pilot trial of IV ketamine + treatment as usual (TAU) vs. midazolam (an active placebo) + TAU to estimate sample size for a full-scale RCT examining these treatments for decreasing suicidal ideation among depressed inpatients with major depressive disorder and bipolar depression.~A total of 52 patients will be recruited for this trial. All subjects will be inpatients at Sunnybrook Health Sciences Centre with a diagnosis of either major depressive disorder or bipolar disorder type I or II currently depressed. Suicidal ideation must be present at baseline assessment in order to be included in the study. Thirteen subjects will be randomized to each treatment arm in each treatment stream - that is, 13 will be recruited to ketamine + TAU in the major depressive disorder stream, and 13 will be recruited to the midazolam + TAU in the major depressive stream. Likewise, 26 subjects with bipolar depression will be randomized to these two treatments.", - "NCTID": "NCT02593643" - }, - { - "brief_title": "Modafinil for Atypical Depression", - "phase": "Phase 2; Phase 3", - "drugs": "['modafinil']", - "drugs_list": [ - "modafinil" - ], - "diseases": "['Atypical Depression']", - "diseases_list": [ - "Atypical Depression" - ], - "enrollment": "65.0", - "inclusion_criteria": "inclusion criteria: \n\n adults 18-65 years of age \n\n DSM-IV criteria for major depressive episode with atypical features as assessed by the Atypical Depression Diagnostic Scale \n\n minimum score of 18 on the Hamilton Depression Scale (29-item version) at baseline \n\n baseline Clinical Global Impressions Severity score of 4 or more \n\n written informed consent \n\n negative serum pregnancy test for women of childbearing potential \n\n ", - "exclusion_criteria": ": \n\n any current primary DSM-IV Axis I disorder other than depression \n\n history of DSM-IV diagnosis of bipolar I disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition \n\n history of substance abuse or dependence within the last 3 months \n\n suicide risk or serious suicide attempt with the last year \n\n clinically significant medical condition or laboratory or EKG abnormality \n\n history of non-response to three prior adequate trials of antidepressants \n\n women of childbearing potential who are unwilling to practice an acceptable method of contraception \n\n history of hypersensitivity to modafinil \n\n use of an investigational medication within the last 28 days \n\n use of antidepressant medication with 28 days of screening", - "brief_summary": "The purposes of the study are to: 1) evaluate the short-term efficacy and safety of modafinil in atypical depression; and 2) to evaluate the efficacy of modafinil in preventing relapse of atypical depression. The hypothesis is that modafinil is safe and effective in the treatment of atypical depression.", - "NCTID": "NCT00215176" - }, - { - "brief_title": "Transcranial Direct Current Stimulation (tDCS) and Cognitive Task in Depression", - "phase": "Phase 1", - "drugs": "['Transcranial direct current stimulation combined with cognitive training']", - "drugs_list": [ - "Transcranial direct current stimulation combined with cognitive training" - ], - "diseases": "['Depression']", - "diseases_list": [ - "Depression" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Participants are aged 18-65 years. \n\n Participant meets criteria for a DSM-V Major Depressive episode. Criteria are as follows: Five or more symptoms present during the same 2-week period, including either 1 or 2: 1) depressed mood, 2) loss of interest or pleasure, 3) significant weight loss or gain, 4) insomnia or hypersomnia, 5) psychomotor agitation or retardation, 6) fatigue or loss of energy, 7) feelings of worthlessness or excessive or inappropriate guilt, 8) diminished ability to think concentrate or make decisions, and 9) recurrent thoughts of death, recurrent suicidal ideation, suicide attempt or plan. \n\n MADRS score of 20 or more. \n\n Right handed \n\n A history of non-response to \u2265 2 adequate trials of antidepressant medication treatment. \n\n ", - "exclusion_criteria": ": \n\n DSM-V psychotic disorder. \n\n Drug or alcohol abuse or dependence (preceding 6 months). \n\n Inadequate response to ECT (current episode of depression). \n\n Regular benzodiazepine medication \n\n Rapid clinical response required, e.g., due to high suicide risk. \n\n Clinically defined neurological disorder or insult. \n\n Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites. \n\n Pregnancy.", - "brief_summary": "Among antidepressant treatments, electroconvulsive therapy (ECT) remains the most effective. However, patient concerns with cognitive side effects have encouraged trials of new, non-convulsive forms of mild brain stimulation such as transcranial Direct Current Stimulation (tDCS). Our past and present studies of tDCS suggest that it has antidepressant effects and is safe, painless and well tolerated. However, not all patients may have an adequate response, raising the need to find ways of optimising efficacy. This clinical pilot study will examine the feasibility and safety of combining tDCS with a cognitive training task which engages the same brain region targeted by tDCS for treatment of depression.", - "NCTID": "NCT02296437" - }, - { - "brief_title": "Prevention of Seasonal Affective Disorder", - "phase": "Phase 3", - "drugs": "['Extended-release bupropion hydrochloride']", - "drugs_list": [ - "Extended-release bupropion hydrochloride" - ], - "diseases": "['Seasonal Affective Disorder']", - "diseases_list": [ - "Seasonal Affective Disorder" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient has a history of Major Depressive Disorder (MDD) with a seasonal pattern. \n\n ", - "exclusion_criteria": ": \n\n Patient has a current or past history of seizure disorder or brain injury. \n\n Patient has a history or current diagnosis of anorexia nervosa or bulimia. \n\n Patient has recurrent summer depression more frequently than winter depression. \n\n Patient has primary diagnosis of panic disorder, Obsessive Compulsive Disorder (OCD), Posttraumatic Stress Disorder (PTSD), acute distress disorder, bipolar II disorder or other psychotic disorders. \n\n Patient has initiated psychotherapy within the last 3 months.", - "brief_summary": "This is a placebo controlled study evaluating the effectiveness of medication in preventing depressive episodes in subjects with a history of Seasonal Affective Disorder (SAD).", - "NCTID": "NCT00046241" - }, - { - "brief_title": "MoodHelper: Internet Cognitive Behavioral Therapy (CBT) for Depression", - "phase": "", - "drugs": "['Pure self-help Internet CBT for depression', 'Guided self-help Internet CBT', 'Stepped-Care Internet CBT condition']", - "drugs_list": [ - "Pure self-help Internet CBT for depression", - "Guided self-help Internet CBT", - "Stepped-Care Internet CBT condition" - ], - "diseases": "['Depression']", - "diseases_list": [ - "Depression" - ], - "enrollment": "1816.0", - "inclusion_criteria": "inclusion criteria: \n\n Participants must have a score \u2265 10 on the self-report Patient Health Questionnaire (PHQ-8), indicative of clinically significant, moderate depression. \n\n Participants must identify their primary healthcare provider in one of the 8 performance sites, and give permission to contact him or her for the purpose of periodic progress reports as well as a referral contact in case any emergent crises are detected. \n\n Participant must be 18 years of age have access to a computer with internet and a working email address. \n\n Participants must also indicate they are planning to continue receiving services from one of the performance site clinics/organizations for at least the next 6 months", - "exclusion_criteria": "", - "brief_summary": "Evidence-based treatments (EBTs) for mental health conditions are often not available to persons needing them in the community. Our aim is to test a novel Internet intervention that has the promise of eventually improving the Reach and Implementation of mental health EBTs, speeding the translation of research successes into improved community care.", - "NCTID": "NCT01379027" - }, - { - "brief_title": "The Serotonin Transporter Availability for Prognosing Major Depressive Disorder (MDD) Treatment and Detecting MDD", - "phase": "Phase 2", - "drugs": "['Sertraline HCl', 'I-123-ADAM SPECT']", - "drugs_list": [ - "Sertraline HCl", - "I-123-ADAM SPECT" - ], - "diseases": "['Major Depressive Disorder']", - "diseases_list": [ - "Major Depressive Disorder" - ], - "enrollment": "37.0", - "inclusion_criteria": "inclusion criteria: \n\n - For MDD subjects \n\n Subject meets the DSM-IV criteria for MDD \n\n Subject has a minimum score of 18 on the 17-item HAMD total score \n\n Subject has a minimum score of 2 on item 1, depressed mood, of HAMD \n\n Subject is free from prior antidepressant medication for at least 5 times of elimination half-lives \n\n For healthy subjects \n\n Subject without past or current neuropsychiatric illnesses based on a clinical interview including Mini-International Neuropsychiatric Interview (M.I.N.I.) and a physical examination \n\n Subject without exposure to psychotropic medication or other substances known to affect the brain serotonin system within 1 year prior to entering the study \n\n ", - "exclusion_criteria": ": \n\n Subject with history of any co-morbid neuropsychiatric disease \n\n Subject with history of treatment resistant to at least two full doses and courses of antidepressant medication \n\n Subject with history of alcohol or substance dependence or abuse \n\n Subject with allergic history to the investigational products \n\n Subject with severe cardiovascular disease or cerebrovascular disease which is judged by investigators for safety concerns as inappropriate for this study \n\n Subject with malignancy within past 5 years \n\n Subject with any diseases judged by investigators as inappropriate for this study \n\n Female subject being pregnant, nursing, or lactating \n\n Female subject of childbearing potential not using a medically acceptable form of birth control \n\n Subject is unable to undergo MRI scan to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations \n\n Subject participated in any investigational drug trial within 4 weeks before entering this study", - "brief_summary": "Objectives:~To evaluate the relationship between improvement of Hamilton Depression Rating Scale (HAMD) score and basal SERT availability (binding potential) for the prognosis of MDD subjects being treated with Sertraline HCl~To evaluate the SERT availability by means of I-123-ADAM SPECT imaging study for assisting in detecting MDD~To evaluate the relationship between basal HAMD score and basal SERT availability for MDD subjects~To evaluate the relationship between basal HAMD somatic subscale score and basal SERT availability for MDD subjects~To evaluate the relationship between change of SERT availability and change of HAMD score for MDD patients being treated with Sertraline HCl", - "NCTID": "NCT02473783" - }, - { - "brief_title": "Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder", - "phase": "Phase 3", - "drugs": "['Duloxetine Hydrochloride']", - "drugs_list": [ - "Duloxetine Hydrochloride" - ], - "diseases": "['Depressive Disorder']", - "diseases_list": [ - "Depressive Disorder" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Signed the informed consent \n\n Meet criteria for major depressive disorder without psychotic features. \n\n Have a level of understanding sufficient to provide informed consent and to communicate with the investigator and site personnel. \n\n Have had at least one other major depressive episode prior to the one being experienced at study entry. \n\n You are reliable and agree to keep all appointments for clinic visits, tests and procedures required by the protocol. \n\n ", - "exclusion_criteria": ": \n\n You have had treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry. \n\n Any women who are pregnant or breast feeding. \n\n If you have any serious medical illnesses other than major depressive disorder. \n\n If you have previously participated in a clinical trial for duloxetine. \n\n Any previous or current diagnosis of bipolar, schizophrenia, or other psychotic disorders.", - "brief_summary": "The purpose of this study is to determine if duloxetine is effective when compared to placebo in preventing recurrence of major depressive disorder in patients who have responded to open-label duloxetine treatment.", - "NCTID": "NCT00036309" - }, - { - "brief_title": "A Neuroimaging Investigation of Brain Activity in Major Depressive Disorder and Bipolar Disorder", - "phase": "Phase 4", - "drugs": "['Fluoxetine+Olanzapine', 'Olanzapine', 'Functional Magnetic Resonance Imaging']", - "drugs_list": [ - "Fluoxetine+Olanzapine", - "Olanzapine", - "Functional Magnetic Resonance Imaging" - ], - "diseases": "['Major Depressive Disorder']", - "diseases_list": [ - "Major Depressive Disorder" - ], - "enrollment": "42.0", - "inclusion_criteria": "inclusion criteria: (All three groups) \n\n age 18-55 years \n\n satisfactory physical health \n\n education level and a degree of understanding to communicate effectively with the investigator c \n\n capable of providing informed consent \n\n female subjects of childbearing potential, a medically accepted means of contraception. \n\n Additional inclusion criteria for the patient groups include \n\n DSM-IV-TR criteria for a diagnosis of BD or MDD \n\n currently meeting criteria for an MDE and \n\n a Hamilton Depression Rating Scale 17 Item (HDRS-17) score of > 17 \n\n blood indices within normal clinical ranges. \n\n ", - "exclusion_criteria": ": (All three groups) \n\n DSM-IV-TR criteria for substance abuse or dependence (except nicotine or caffeine) within the past 6 months \n\n comorbid neurological or other major psychiatric disorders as defined in the DSM-IV-TR; \n\n history of neurological trauma resulting in loss of consciousness; \n\n uncorrected hypothyroidism or hyperthyroidism, including elevated thyroid stimulating hormone (TSH); \n\n other unstable medical condition; \n\n female subjects who are pregnant or nursing; \n\n Additional ", - "brief_summary": "This study employs functional magnetic resonance imaging to compare brain activation patterns during a depressive episode in patients diagnosed with bipolar disorder, major depressive disorder, and a group of healthy control subjects. Depressed patients will be treated with a combination of fluoxetine and olanzapine and undergo MRI scans before, during, and after pharmacotherapy.", - "NCTID": "NCT00188942" - }, - { - "brief_title": "Lithium Versus Paroxetine in Patients With Major Depression Who Have a Family History of Bipolar Disorder or Suicide", - "phase": "Phase 3", - "drugs": "['paroxetine', 'lithium']", - "drugs_list": [ - "paroxetine", - "lithium" - ], - "diseases": "['Major Depressive Disorder']", - "diseases_list": [ - "Major Depressive Disorder" - ], - "enrollment": "2.0", - "inclusion_criteria": "inclusion criteria: \n\n Not currently participating in a drug or medical device clinical trial \n\n Male or female over the age of 18 \n\n DSM - IV Diagnosis of major depression \n\n Positive family history of bipolar disorder or completed suicide \n\n ", - "exclusion_criteria": ": \n\n Not able to give informed consent \n\n Pregnant or breast-feeding \n\n Current additional psychiatric diagnoses including Panic Disorder, Post -Traumatic Stress Disorder (PTSD) or Psychosis \n\n History of mania or hypomania \n\n Active substance abuse or dependence in the last 6 months \n\n Current depressive episode less than 4 weeks or greater than 12 months in duration \n\n Current or prior adequate trial of lithium or paroxetine \n\n Current use of other medications such as antidepressants for the treatment of depression \n\n Clinically significant medical illness, in particular kidney problems", - "brief_summary": "This study is being done to look at how well people respond to two very different drug treatments for depression. Clinically, people with depression can respond differently to drug treatments for reasons which are not always clear. Some of our own recent research suggests that people with depression who have a family history of bipolar disorder or completed suicide, may react differently to standard antidepressant medications than those without such a family history. Our data shows that family history of completed suicide, as well as the known predictor of family history of bipolar disorder, may help identify a pre-bipolar high risk group i.e. they currently have depression but at some future date will declare a bipolar illness (manic-depression) by virtue of development of a manic episode also. Our research suggests that treatment- emergent symptoms in response to a trial of antidepressant, such as agitation may be strong predictors of future bipolarity and inherently dangerous particularly as they are not ascribed to the antidepressant treatment. Finally, it is possible that this subgroup of those with depressive illness may respond better and more safely to lithium, a mood stabiliser used in known bipolar depression.~The objective of this proposal is to investigate response to acute lithium treatment in subjects who meet the diagnostic criteria for major depression, but who are potentially at risk for bipolar disorder, by virtue of family history of bipolarity or completed suicide.", - "NCTID": "NCT00400088" - }, - { - "brief_title": "Jump Step - A Participatory Approach to Physical Activity & Mental Wellness", - "phase": "", - "drugs": "['Group Medical Visits']", - "drugs_list": [ - "Group Medical Visits" - ], - "diseases": "['Major Depressive Disorder', 'Bipolar, Depression']", - "diseases_list": [ - "Major Depressive Disorder", - "Bipolar", - "Depression" - ], - "enrollment": "80.0", - "inclusion_criteria": "We will recruit up to 80 participants who \n\n inclusion criteria: \n\n are adults (\u226518yrs) \n\n have a confirmed psychiatric assessment of Major Depressive Disorder (MDD) and/or Bipolar II, depressive \n\n are of moderate or higher severity (PHQ-9 >14) \n\n are community-dwelling and able to attend Group Medical Visits in the Lower Mainland \n\n are able to comply with scheduled visits, treatment plan, and other procedures; \n\n read, write, and speak English with acceptable auditory and visual acuity \n\n provide signed/dated informed consent; and \n\n able to walk independently. \n\n ", - "exclusion_criteria": ": \n\n Active psychotic symptoms \n\n a primary active diagnosis of substance abuse. \n\n Participants will need to have a working proficiency in English as group discussions, accompanying texts, and instructions will all be in English. To provide adequate translation services for these elements in one or more other languages is beyond our budget and may also influence the dynamics of the GMV. It could be considered in a future iteration of this research program.", - "brief_summary": "The WHO, the Pan American Health Organization, the EU Council of Ministers, the World Federation of Mental Health, and the UK Royal College of Psychiatrists all agree -there can be no health without mental health. Within Canada, 6.7M people live with a mental illness and when family and caregivers are included almost everyone is affected.~A systematic review (2014) concluded that physical activity has a significant potential for reducing depressive symptoms in people with a mental illness. Globally, physical inactivity is pandemic. Current guidelines recommend a minimum of only a 150 minutes a week of moderately vigorous exercise but 85% of Canadians do not meet the national recommendations. How then can people with depression be motivated to become physically more active?~Group Medical Visits (GMVs) can be used to provide health services and they have proven effective in some settings, including mood disorders. As well as providing economic and resource efficiencies, the GMV model has the potential to add a 'support group/accountability' element for behavioural interventions such as physical activity promotion; such influence is not present in an individual patient-physician consultation.~Jump Step is a 14-week program within a GMV setting designed to motivate and support people with depression to engage in regular physical activity. The investigators seek to design, implement, and evaluate the effectiveness of the Group Medical Visits focused on promoting physical activity for patients with depression.", - "NCTID": "NCT02549547" - }, - { - "brief_title": "Efficacy Study of Korean Red Ginseng to Treat Depression", - "phase": "", - "drugs": "['Korean Red Ginseng']", - "drugs_list": [ - "Korean Red Ginseng" - ], - "diseases": "['Major Depressive Disorder']", - "diseases_list": [ - "Major Depressive Disorder" - ], - "enrollment": "35.0", - "inclusion_criteria": "inclusion criteria: \n\n Outpatients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder. \n\n Those who are in remission, which is defined as a MADRS score 8 on two consecutive visits at a 4-week interval. \n\n Their primary psychiatric clinician determined that they would benefit from an adjuvant treatment of Korean red ginseng for residual symptoms. \n\n ", - "exclusion_criteria": ": \n\n Those who have a history of substance abuse or dependence within 1 month. \n\n Those who have clinically significant abnormal laboratory values or any other abnormal baseline laboratory findings considered by psychiatrists to be indicative of conditions that might affect the study results. \n\n Those who have a past history of hypersensitivity or intolerance to Korean red ginseng. \n\n Those who participated in clinical trials within 1 month before entering the study entry. \n\n Those who are pregnant or are breast feeding. \n\n Those who have a immediate risk of harming self or others or history of suicide attempts in the year before the screening precluded inclusion in the study. \n\n The patients unable/unlikely to comprehend/follow the protocol.", - "brief_summary": "The purpose of this study is to determine whether Korean Red Ginseng are effective in the treatment of the residual symptoms of depression as an adjuvant treatment.", - "NCTID": "NCT01496248" - }, - { - "brief_title": "Interventional Study of Wellbutrin XL in Major Depressive Disorder With Atypical Features", - "phase": "Phase 4", - "drugs": "['Bupropion extended release']", - "drugs_list": [ - "Bupropion extended release" - ], - "diseases": "['Depressive Disorder, Major']", - "diseases_list": [ - "Depressive Disorder", - "Major" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Age over 20 years \n\n DSM-IV episode of MDD non-psychotic with atypical features characterized by mood reactivity and 2 or more symptoms of vegetative reversal (including overeating, oversleeping, severe fatigue or leaden paralysis, and a history of rejection sensitivity) \n\n More than 19 score on the 29-item HAM-D \n\n Ability to give informed consent \n\n ", - "exclusion_criteria": ": \n\n Bipolar depression \n\n Any Axis I psychotic disorder \n\n A history of suicide attempt, self-injurious action (excluding action with no intention of suicide) or overdosage (excluding apparently accidental overdosage) \n\n Patients with more than 3-point score of suicide (HAM-D-29 Item 18) or patients whose C-SSRS assessment suggests that they are or have been at significant risk for harming themselves or have actually harmed themselves, or who, in the opinion of the investigator (sub-investigator), are at significant risk for harming self or others \n\n A history of substance abuse in the previous 12 months \n\n A history of hypersensitivity to bupropion or any other components of the preparations used in the study (Wellbutrin SR 150mg and Wellbutrin XL 300 mg tablets) \n\n Serious or unstable medical disorders \n\n Starting or terminating psychotherapy during the previous 12 weeks, \n\n ECT treatment in the previous 3 months \n\n Subject has a life time diagnosis of anorexia nervosa or bulimia within the past 12 month \n\n Subject has a current or history of seizure disorder or brain injury (traumatic or disease-related) or any condition which predisposes to seizure- subject treated with other medications or treatment regimens that lower seizure threshold- subject undergoing abrupt discontinuation of alcohol or sedatives \n\n Subjects that previously failed adequate courses of pharmacotherapy from two different classes of antidepressants or previous adequate course(s) of bupropion \n\n Pregnancy or planning pregnancy - when a patient is in active reproductive age, he or she has to agree to use relevant contraception during the study \n\n Patients on monoamine oxidase inhibitors (MAOIs) \n\n Patients being treated with any other preparations containing bupropion as the incidence of seizures is dose dependent", - "brief_summary": "The aims of this study are 1) to examine the clinical utility of bupropion hydrochloride extended release (Wellbutrin XL\u00ae) in patients with Major Depressive Disorder (MDD) with atypical features; 2) to evaluate the tolerability of bupropion hydrochloride extended release (Wellbutrin XL\u00ae) in patients with MDD with atypical features.", - "NCTID": "NCT01477931" - }, - { - "brief_title": "Therapy for Undergraduate College Students Who Binge Drink and Are Depressed", - "phase": "", - "drugs": "['Combined Motivational Interviewing and Cognitive Behavioral Therapy', 'Cognitive Behavioral Therapy']", - "drugs_list": [ - "Combined Motivational Interviewing and Cognitive Behavioral Therapy", - "Cognitive Behavioral Therapy" - ], - "diseases": "['Depression', 'Alcohol Abuse']", - "diseases_list": [ - "Depression", - "Alcohol Abuse" - ], - "enrollment": "96.0", - "inclusion_criteria": "inclusion criteria: \n\n Currently enrolled in college as an undergraduate student. \n\n Ages 18-24 years (inclusive). \n\n Presence of two binge drinking episodes in the past month (defined as consumption of 5 or more drinks in 2 hours for males and 4 for females; NIAAA, 2004). \n\n BDI-II 12 (12 is often used to indicate the presence of at least mild depressive symptoms) and <30 (indicating severe depression). \n\n ", - "exclusion_criteria": ": \n\n Meeting criteria for substance dependence or abuse (any substance) in the past six months (students with alcohol abuse will not be excluded). \n\n Diagnosis of bulimia, psychosis, or bipolar disorder. \n\n Having received any psychosocial treatment for depression or substance abuse in the past month. \n\n Having received CBT for depression and/or alcohol use in the previous 6 months. \n\n If receiving pharmacological treatment for depression or substance abuse, has not been on a stable dose for at least 4 weeks. \n\n Discontinued an antidepressant medication less than 1 month ago. \n\n Meeting criteria for severe depression or posing a serious suicide or homicide risk.", - "brief_summary": "The purpose of this study is to investigate the effectiveness of 2 different therapy courses for undergraduate college students who binge drink and experience depressive symptoms.", - "NCTID": "NCT01632319" - }, - { - "brief_title": "Electroencephalography (EEG) Biomarkers of Response in Depression", - "phase": "Phase 4", - "drugs": "['venlafaxine (Effexor)', 'placebo']", - "drugs_list": [ - "venlafaxine (Effexor)", - "placebo" - ], - "diseases": "['Major Depressive Disorder']", - "diseases_list": [ - "Major Depressive Disorder" - ], - "enrollment": "44.0", - "inclusion_criteria": "inclusion criteria: \n\n All subjects will meet DSM-IV criteria for depression on the basis of a SCID-P interview, with subjects having a score on the 17-item Ham-D > 17 (with item #1 > 2). \n\n Subjects will meet criteria both at recruitment and after a one-week single blind placebo wash-in. Study includes outpatients only. \n\n ", - "exclusion_criteria": ": \n\n All subjects will have no serious medical illness. The investigators will exclude patients also meeting criteria for the following groups of axis I diagnoses: \n\n delirium or dementia \n\n substance-related disorders \n\n schizophrenia or other psychotic disorders, or eating disorders. \n\n In addition, patients meeting criteria for cluster A or B axis II diagnoses will be excluded. \n\n Subjects with a history of current or past active suicidal ideation, or suicide attempts will be excluded from the study.", - "brief_summary": "There are two specific aims of this project:~To identify physiologic indicators of venlafaxine treatment response using quantitative EEG (QEEG) cordance, and to determine if cordance changes are specifically associated with response to venlafaxine~To identify predictors of placebo response in major depression using QEEG cordance/bispectral index (BIS) and neuropsychological testing", - "NCTID": "NCT00759122" - } - ], - "2": [ - { - "brief_title": "Acupuncture in the Treatment of Depression", - "phase": "Phase 3", - "drugs": "['Acupuncture']", - "drugs_list": [ - "Acupuncture" - ], - "diseases": "['Depressive Disorders', 'Depression']", - "diseases_list": [ - "Depressive Disorders", - "Depression" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Must meet criteria for Major Depression. \n\n Must be free of other mental or physical disorders that could cause depression, and also free from conditions that would typically exclude participants from trials involving pharmacologic antidepressants. \n\n Cannot be receiving other treatments or require immediate clinical attention.", - "exclusion_criteria": "", - "brief_summary": "The current large randomized placebo-controlled trial is testing the ability of acupuncture to treat major depression. The study is unique in that treatment effects will be from the perspective of both Western psychiatry and Chinese medicine.", - "NCTID": "NCT00010517" - }, - { - "brief_title": "OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females", - "phase": "Phase 2", - "drugs": "['onabotulinumtoxinA', 'Normal Saline']", - "drugs_list": [ - "onabotulinumtoxinA", - "Normal Saline" - ], - "diseases": "['Depressive Disorder, Major']", - "diseases_list": [ - "Depressive Disorder", - "Major" - ], - "enrollment": "258.0", - "inclusion_criteria": "inclusion criteria: \n\n Moderate to severe major depressive disorder \n\n ", - "exclusion_criteria": ": \n\n Prior treatment with botulinum toxin of any serotype for any reason \n\n Use of antidepressant medication for depression within 2 weeks of study \n\n Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis", - "brief_summary": "This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX\u00ae) compared with placebo as treatment for major depressive disorder (MDD) in adult females.", - "NCTID": "NCT02116361" - }, - { - "brief_title": "The Effect of Fish Oil in Major Depressive Disorder", - "phase": "Phase 2; Phase 3", - "drugs": "['Omega-3 fatty acids', 'placebo']", - "drugs_list": [ - "Omega-3 fatty acids", - "placebo" - ], - "diseases": "['Major Depressive Disorder']", - "diseases_list": [ - "Major Depressive Disorder" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n DSM-IV criteria for major depressive disorder. \n\n Age being age 18-65. \n\n Capacity and willingness to give written informed consent. \n\n ", - "exclusion_criteria": ": \n\n Any major medical illnesses. \n\n A recent or past history of any Axis-I diagnoses besides major depressive disorder, including psychotic disorders; cognitively impaired mental disorders; impulse control disorders; substance use disorder or substance abuse (last 6 months prior to the studies); primary anxiety disorders, including post-traumatic stress disorder and panic disorder; and bipolar disorders; or Axis-II diagnoses, i.e. borderline and antisocial personality disorder.", - "brief_summary": "The first part is a double-blind placebo-controlled trial to identify the effects of omega-3 polyunsaturated fatty acids (PUFAs) monotherapy in depression. The second part is a double-blind trial to identify the effects of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on different symptom clusters in patients with depression.", - "NCTID": "NCT01371383" - }, - { - "brief_title": "Effectiveness of School-Based Cognitive Behavioral Therapy in Preventing Depression in Young Adolescents", - "phase": "Phase 3", - "drugs": "['Adolescent only Penn Resiliency Program (Adolescent PRP)', 'Parent Penn Resiliency Program (Parent PRP)']", - "drugs_list": [ - "Adolescent only Penn Resiliency Program (Adolescent PRP)", - "Parent Penn Resiliency Program (Parent PRP)" - ], - "diseases": "['Depression', 'Anxiety']", - "diseases_list": [ - "Depression", - "Anxiety" - ], - "enrollment": "400.0", - "inclusion_criteria": "inclusion criteria: \n\n Student with above average levels of depression and anxiety symptoms (students with average or below average symptoms will be enrolled into the study space permitting) \n\n ", - "exclusion_criteria": ": \n\n Not a student in a participating school \n\n Not a student in grades six through eight", - "brief_summary": "This study will evaluate the effectiveness of the Penn Resiliency Program, a school-based cognitive behavioral depression prevention program for young adolescents.", - "NCTID": "NCT00360451" - }, - { - "brief_title": "Follow-up Study With Clinical Vitamin D Supplementation Trial on Patients With Depression (DepFuD)", - "phase": "", - "drugs": "['Vitamin D 10 micrograms', 'Vitamin D 100 micrograms']", - "drugs_list": [ - "Vitamin D 10 micrograms", - "Vitamin D 100 micrograms" - ], - "diseases": "['Depression', 'Depressive Disorder']", - "diseases_list": [ - "Depression", - "Depressive Disorder" - ], - "enrollment": "3028.0", - "inclusion_criteria": "inclusion criteria: \n\n patients referred to the recruitment sites for treatment for depression \n\n mild, moderate or severe depression, \n\n mild, moderate or severe episode of recurrent depression \n\n ", - "exclusion_criteria": ": \n\n bipolar or psychotic depression \n\n psychotic disorder \n\n severe substance abuse \n\n disabilities in senses that affect functioning and severely threat completing the trial \n\n diseases that affect vitamin D metabolism (such as sarcoidosis, hypercalcemia, hypofunction of kidney) \n\n pregnancy or lactation \n\n current use of high dose vitamin D supplementation \n\n current use of high dose calcium supplementation", - "brief_summary": "Depression affects 350 million people worldwide. In the light of the global disease burden statistics, the efficacy of current treatments for depression appears insufficient. Thus, research on novel treatment interventions and predictors for good treatment response are warranted. Earlier prospective follow-up studies and intervention studies suggest that several bio-psychosocial factors, including high serum concentrations of vitamin D, are related to better treatment outcomes. In this follow-up study with randomized clinical vitamin D supplementation trial on patients with depression, the investigators aim to~clarify how a six-month intervention with vitamin D supplementation affects treatment response, recovery, and the biological pathways related to depression. This aims to finding potential sub-groups getting benefits from vitamin D supplementation. In addition, the investigators want to~investigate and characterize factors related to recovery from depression and working ability in depression patients in the long-term. The investigators are especially interested in the bio-psychosocial factors and the aims include examining both the individual's positive resources.~The trial will start with a six-month double-blinded randomized controlled trial with vitamin D supplementation. The aim is to recruit altogether 3028 patients with non-psychotic, unipolar depression, aged 18-65 years, who are referred to the recruitment sites for treatment for depression. The participants will be randomized to low (10 \u00b5g/day) or high (100 \u00b5g/day) vitamin D supplementation group. Clinically necessary antidepressant treatments will continue during the intervention as needed. After six months of intervention, the participants will be followed up at 18 months and at 5 years.~Several measurements will be conducted during the intervention and follow-up period. Participants will fill a variety of clinical questionnaires and questionnaires with background information. All participants give blood samples for biomarker analyses at time points 3, 6, 18 months and 5 years. Clinical interviews of mental disorders (e.g. SCID) and anthropometric measurements (e.g. weight, height, blood pressure) will be carried out.", - "NCTID": "NCT02521012" - }, - { - "brief_title": "Effectiveness and Acceptability of Internet-delivered Treatment for Depression, Anxiety and Stress", - "phase": "", - "drugs": "['Space from Depression', 'Space from Anxiety', 'Space from Stress']", - "drugs_list": [ - "Space from Depression", - "Space from Anxiety", - "Space from Stress" - ], - "diseases": "['Depression', 'Anxiety', 'Stress']", - "diseases_list": [ - "Depression", - "Anxiety", - "Stress" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Participants must be at least 18 years of age. Participants must have self-reported mild to severe symptoms of depression (5-27+) according to PHQ-9, self-reported mild to severe symptoms of anxiety (5-21+) according to GAD-7, or self-reported mild to severe symptoms of stress (15-34+) according to the stress sub-scale of DASS-21. \n\n ", - "exclusion_criteria": ": \n\n Students who currently are in face-to-face therapy at UCCS or BHS will be excluded. Students who score in the red zone in terms of risk of self-harm on the screening questions routinely used at UCCS will not be referred to the study. Students who score greater than 0 on the PHQ-9 self-harm item during the initial screening phase will be automatically directed to be further evaluated and alerted that a counselor will try to reach them. Based on this further evaluation, they may be recommended to seek help from their health/counseling service and may/may not be eligible to participate in the study. They will be telephoned within 1 working day and contacted by email if they cannot be reached by phone.", - "brief_summary": "The aims of this study are to test the effectiveness and acceptability of internet-delivered treatment for depression, anxiety and stress in university students. These data will inform the methods for a future randomized controlled trial.~The trial will establish an initial estimate of the effectiveness of these online interventions for students in terms of within-group effect sizes associated with changes in depression, anxiety and stress from pre to post-intervention and follow-up. These data will be used to estimate the sample size for a future trial to ensure that the study is sufficiently powered. A conservative estimate using the 90% upper confidence limit will be used to inform the sample size calculation of the definitive RCT.~Acceptability of the intervention to participants will be assessed using data on usage and engagement with the intervention (e.g. percentage of participants completing each module, average number of log ins, average time spent per session and total time spent on the program). These data are acquired through the online SilverCloud system. Satisfaction with will be assessed through the use of a post-intervention questionnaire on satisfaction with accessing and using an online delivery format for treatment.", - "NCTID": "NCT02614443" - }, - { - "brief_title": "Objective Diagnostic Markers and Personalized Intervention in MDD Patients", - "phase": "", - "drugs": "['SSRIs']", - "drugs_list": [ - "SSRIs" - ], - "diseases": "['Depressive Disorder, Major']", - "diseases_list": [ - "Depressive Disorder", - "Major" - ], - "enrollment": "2400.0", - "inclusion_criteria": "For MDD group: \n\n inclusion criteria: \n\n Age between 18-55, male or female; \n\n The diagnosis of MDD consistent with DSM-IV (M.I.N.I) \n\n First-episode or relapsed; \n\n Certain ability of reading and writing to complete the questionnaire survey and psychological assessment. \n\n All participants provide written confirmation of informed consent prior to engaging the study protocol. \n\n ", - "exclusion_criteria": ": \n\n Current psychopathology or a history of neurologic conditions, including alcohol/substances dependence, the diagnosis of cognition impairment; \n\n Severe somatic diseases, such as severe cardio-cerebral vascular diseases, respiratory diseases, liver diseases, kidney diseases, or malignant tumors; \n\n Not signed the informed consent; \n\n Been engaging other studies. \n\n For Healthy control group \n\n inclusion criteria: \n\n age between 18 and 55 years at the time of enrollment; \n\n providing written confirmation of informed consent prior to engaging the study. \n\n ", - "brief_summary": "Major depressive disorder (MDD) is one of the most common psychiatric disorders, with high recurrence rate, suicide rate and disability rate. It's reported that the global burden caused by MDD will be up to the second rank among all the disease burdens by 2020. China is also confronted with the daunting challenges against MDD. It's assessed that the monthly incidence of MDD is 6.1%, non-hospitalizing rate reaches up to 92% and the non-treatment rate is approximate 95%. However, to date, the pathogenesis of MDD is obscure and the current therapies don't work well. Therefore, it's urgent and critical to elucidate the pathogenesis of MDD, to develop early diagnostic criteria and effective intervention in MDD. Considering the diversity of weights on genetic factor and environmental factor in MDD, in this project, the investigators aim firstly to explore the effect of genetic-environmental interactionon the pathogeny of MDD for classifying MDD into genetic type, environmental type and others based on a case-control study. We next conduct the neurobiological, neurocognitive and psycho-behavioral assessments among MDD, schizophrenia and healthy groups to screen the salient endophenotypes for establishing the diagnostic models of MDD . The investigators further analyse the changes of these indicators after 8 weeks'medication to select the potential predictors for therapeutic evaluations and interventional options in MDD patients. Finally, the investigators continue a 2-year follow-up study to test and verify the predictors of prognosis in MDD patients.", - "NCTID": "NCT02023567" - }, - { - "brief_title": "MRI Study of Brain Activity and Risk for Depression in Adolescents", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Involutional Depression', 'Anxiety Disorders']", - "diseases_list": [ - "Involutional Depression", - "Anxiety Disorders" - ], - "enrollment": "88.0", - "inclusion_criteria": "OFFSPRING SUBJECTS - inclusion criteria: \n\n Age: 10-30. \n\n Can give consent/assent. Parents will provide consent for all minors. \n\n All subjects will have IQ greater than 80. \n\n High risk Psychopathology: Offspring of adults with a history of MDD. \n\n Low risk Psychopathology: Offspring of adults with no history of MDD and low developmental levels of emotion dysregulation. Subjects born to parents with only anxiety disorders will be included in this group. \n\n OFFSPRING SUBJECTS - ", - "exclusion_criteria": ": \n\n Any medical condition that increases risk for MRI (e.g. pacemaker, metallic foreign body in eye). \n\n Pregnancy: \n\n Both groups: All subjects will be free of current impairing affective disorders, separation anxiety disorder, social anxiety disorder, panic disorder, generalized anxiety disorder, PTSD, ADHD, as well as lifetime history of substance dependence, psychosis, pervasive developmental disorder, major affective disorder, obsessive compulsive disorder, conduct disorder, anorexia. All subjects will be born to parents with no history of schizophrenia or bipolar disorder. \n\n PARENT SUBJECTS - inclusion criteria: \n\n Age: 18-55 \n\n Can give consent/assent \n\n Offspring: All subjects will have offspring participating in this same protocol. \n\n Have an IQ greater than 80 \n\n Past history of MDD \n\n No lifetime history of MDD \n\n ADULT SUBJECTS - ", - "brief_summary": "Anxiety in children of parents with major depressive disorder (MDD) poses a particularly high risk for later-life MDD. In adults, MDD involves dysfunction in prefrontal brain regions that regulate attention to emotional stimuli. These abnormalities: i) have been found primarily in adults with specific familial forms of MDD; ii) persist after recovery from MDD, and iii) relate to anxiety. These findings raise the possibility that risk for MDD is tied to dysfunction in prefrontal regions involved in regulation of emotion, which possibly manifests as early-life anxiety. If this possibility were confirmed in never-depressed adolescents at high risk for MDD, the findings would provide key insights into the developmental neurobiology of MDD. The goal of this protocol is to study the neural substrate of risk for MDD in young people. This protocol tests the hypothesis that adolescents at high risk for MDD by virtue of childhood anxiety and parental history of MDD exhibit dysfunction in prefrontal cortex and amygdala, regions involved in emotion regulation. This goal will be accomplished through fMRI studies of emotion regulation in high and low-risk adolescents.~For this research, at-risk adolescents will be recruited from participants in an NIMH-funded extramural study at New York University (NYU) examining the biology of risk for anxiety and depressive disorders. Over a three-year period, 45 high-risk probands and 60 low-risk comparisons will be studied, including 20 comparisons from the NYU sample and 40 from the Washington DC metropolitan area. In the present protocol, to be conducted at NIH, subjects will undergo volumetric MRI scans to assess structural abnormalities in the prefrontal cortex and medial temporal lobe. They will complete a series of four out-of-scanner cognitive tasks and two fMRI-based cognitive tasks that measure modulation of attention to emotional stimuli. The fMRI tasks are hypothesized to differentially engage the prefrontal cortex and amygdala in low vs. high risk subjects. These tasks will be used to test the hypothesis that at-risk individuals exhibit enhanced amygdala and reduced prefrontal activation on the fMRI emotion/attention tasks.", - "NCTID": "NCT00047944" - }, - { - "brief_title": "Incidence of Metabolic Syndrome and Thyroid Dysfunction in Patients With Major Depressive Disorder", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Major Depressive Disorder', 'Metabolic Syndrome', 'Thyroid Dysfunction']", - "diseases_list": [ - "Major Depressive Disorder", - "Metabolic Syndrome", - "Thyroid Dysfunction" - ], - "enrollment": "140.0", - "inclusion_criteria": "inclusion criteria: \n\n patient with major depressive disorder \n\n age over 18 years \n\n ", - "exclusion_criteria": ": \n\n subject who cannot give information.", - "brief_summary": "Aim 1 is to study prevalence and 1 year incidence of metabolic syndrome in major depressive disorder and factors correlation.~Aim 2 is to study prevalence and 1 year incidence of thyroid dysfunction in major depressive disorder and factors correlation.", - "NCTID": "NCT01682785" - }, - { - "brief_title": "Potential Use Of Brain Network Activation Analysis to Diagnose Major Depression", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Major Depressive Disorder']", - "diseases_list": [ - "Major Depressive Disorder" - ], - "enrollment": "70.0", - "inclusion_criteria": "For Patients with Major Depressive Disorder \n\n inclusion criteria: \n\n \u2022 Male and female outpatients, aged 18-55 years \n\n Subjects meeting full criteria for the diagnosis of current Major Depressive Disorder (MDD) without psychotic features, as determined by clinical evaluation and Mood Module of structured diagnostic interview (SCID), completed by the study clinician. \n\n HAM-D17 score of 14 or higher \n\n Able to provide informed consent \n\n Right handed, normal (corrected) vision and normal hearing \n\n ", - "exclusion_criteria": ": \n\n \u2022 Other primary diagnoses including major depressive disorder with psychotic features, bipolar disorder, schizoaffective disorder, schizophrenia, dementia, attention deficit hyperactivity disorder (ADHD). \n\n Substance use disorder (abuse or dependence with active use within the last 6 months). \n\n Significant sensory deficits such as deafness or blindness. \n\n Severe or unstable medical illness, including history of closed head injury resulting in loss of consciousness, seizure disorder; history of neurological disorders. \n\n Pregnant or nursing females who are not using an accepted method of contraception (birth control pill, IUD, combination of barrier methods) \n\n Clinically significant abnormal laboratory values or electrocardiogram For Healthy Controls \n\n inclusion criteria: \n\n Males and females, aged 18-55 years \n\n Subjects who do not meet full criteria for any of the major psychiatric diagnosis including MDD, bipolar disorder, schizophrenia, substance abuse/dependence, attention deficit hyperactivity disorder (ADHD), as determined by clinical evaluation and structured diagnostic interview, completed by the study clinician. \n\n Right handed, normal (corrected) vision and normal hearing \n\n ", - "brief_summary": "The investigators are doing this study to find out if they can use electroencephalographic (EEG) recordings, which measure brain waves, to predict response to antidepressant treatments, as well as to distinguish patients who have depression from those who do not. In particular the investigators want to test the usefulness of a new type of analysis of EEG recordings called brain network activation or BNA. BNA allows to identify patterns of activation in brain networks and to track their changes over time.", - "NCTID": "NCT01579942" - }, - { - "brief_title": "Psychotherapy Plus: Combining Cognitive Behavioral Therapy With tDCS", - "phase": "", - "drugs": "['cognitive behavioral therapy', 'tDCS', 'sham-tDCS']", - "drugs_list": [ - "cognitive behavioral therapy", - "tDCS", - "sham-tDCS" - ], - "diseases": "['Major Depression']", - "diseases_list": [ - "Major Depression" - ], - "enrollment": "209.0", - "inclusion_criteria": "inclusion criteria: \n\n - unipolar major depressive disorder \n\n ", - "exclusion_criteria": ": \n\n neurological diseases or relevant psychiatric diseases other than major depressive disorder \n\n current medication other than SSRI or Mirtazapine \n\n manic episodes (lifetime) \n\n psychotic symptoms (lifetime) \n\n treatment with psychotherapy within the past 2 years \n\n treatment with electroconvulsive therapy (lifetime)", - "brief_summary": "The study will investigate whether cognitive behavioral psychotherapy (CBT) combined with prefrontal transcranial direct current stimulation (tDCS) is more efficacious with regard to symptom reduction in depressed patients than CBT combined with sham-tDCS or CBT alone.", - "NCTID": "NCT02633449" - }, - { - "brief_title": "St. John's Wort Extract LI 160 for the Treatment of Atypical Depression", - "phase": "Phase 3", - "drugs": "[\"St. John's Wort extract\", 'Placebo']", - "drugs_list": [ - "St. John's Wort extract", - "Placebo" - ], - "diseases": "['Atypical Depression']", - "diseases_list": [ - "Atypical Depression" - ], - "enrollment": "201.0", - "inclusion_criteria": "Main inclusion criteria: \n\n Mild to moderate depression (ICD-10 F32.0, F32.1) with atypical features according to DSM-IV, lasting at least 3 months \n\n Female and male Caucasians aged 18 to 70 years \n\n At least one of HAMD-28 scale items 22-26 scores >1", - "exclusion_criteria": "", - "brief_summary": "The aim of tis study is to assess the efficacy and safety of Jarsin\u00ae 300 mg as an acute treatment in mild to moderate depression with atypical features.", - "NCTID": "NCT00861978" - }, - { - "brief_title": "Safety and Efficacy Study of Vilazodone and Discovering Genetic Markers Associated With Response in Patients With Major Depressive Disorder", - "phase": "Phase 2", - "drugs": "['Vilazodone']", - "drugs_list": [ - "Vilazodone" - ], - "diseases": "['Major Depressive Disorder']", - "diseases_list": [ - "Major Depressive Disorder" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Male or female patients 18-65 years of age, inclusive.", - "exclusion_criteria": "", - "brief_summary": "The purpose is to evaluate the safety and usefulness of the investigational drug, vilazodone in depression.", - "NCTID": "NCT00290914" - }, - { - "brief_title": "Examination of Brain Serotonin Receptors in Patients With Mood Disorders", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Mood Disorder', 'Bipolar Disorder', 'Depression']", - "diseases_list": [ - "Mood Disorder", - "Bipolar Disorder", - "Depression" - ], - "enrollment": "214.0", - "inclusion_criteria": "inclusion criteria: \n\n MDD SAMPLES: \n\n Seventy subjects (ages 18 to 60) with MDD will be selected who additionally meet criteria for one of 3 subgroups: \n\n A) MDD, Currently depressed with FPDD, as defined by DSM-IV criteria for recurrent MDD, currently in a major depressive episode, who have a first degree relative with MDD but no first degree relatives with mania, alcoholism, or antisocial personality disorder. \n\n B) MDD, Currently in remission with a history of FPDD, defined as a period of at least six months with no more than one clinically significant symptom, and during which time subjects were not taking an AD agent. Subjects will thus meet the historical criteria for recurrent MDD (DSM-IV). We will also require that subjects previously had a least one antidepressant drug trial, to ensure that the severity of previous episodes warranted treatment. \n\n C) MDD, Currently depressed, non-FPDD. To assess the specificity of the findings in MDD to FPDD, a sample meeting criteria for MDD, currently in a depressive episode, but not FPDD will also be imaged. \n\n BIPOLAR DEPRESSED SAMPLE: \n\n Forty five subjects (ages 18 to 60) who meet DSM-IV criteria for bipolar disorder and are currently in a major depressive episode. Subjects may be inpatients or outpatients. Because effective treatment will not be discontinued for the purposes of this protocol, subjects will be identified who have never been treated or who have discontinued medication due to lack of efficacy, noncompliance, physician order or other reasons prior to study entry. \n\n HEALTHY, LOW RISK, CONTROL SAMPLE: \n\n One hundred and four subjects (ages 18 to 60) who have not met criteria for any major psychiatric disorder. The control subjects will have no known first or second degree relatives with mood disorders. \n\n CUSHINGS DISEASE CONTROL SAMPLE: \n\n Ten subjects (ages 18 to 60) with probable Cushing's Disease will be recruited who have both clinical and biochemical evidence of hypercortisolism (including urinary free cortisol excretion higher than the upper limit of normal (greater than 248) nmole/day, and marked central adiposity, cutaneous atrophy, proximal myopathy, and large purple striae). The diagnosis of probable Cushing's Disease will also have been established prior to referral via CRH and ACTH. \n\n MENSTRUALLY-RELATED DYSPHORIC DISORDER SAMPLE: \n\n (n equals 12; ages 18-50). These females are recruited, screened and diagnosed by collaboration under protocol number 81-M-0126, previously approved by IRB, entitled 'The Phenomenology and Biophysiology of Menstrually Regulated Mood and Behavioral Disorders', principal investigator, David Rubinow, M.D. As described in that protocol these subjects must have a regular menstrual cycle lasting 21 - 33 days and meet the following criteria: 1) history within the last two years of at least six months with menstrually-related mood or behavioral disturbances of at least moderate severity - that is, disturbances that are distinct in appearance and associated with a notable degree of subjective distress; 2) a 30 percent increase in mean negative mood ratings (relative to the range of the scale employed) in the premenstrual week compared with the week following the end of menses in at least two of the three cycles; 3) age 18 to 50; 4) not pregnant and in good medical health; 5) regular menses. \n\n REMITTED MDD WITH AND WITHOUT A HISTORY OF PPD: \n\n (n=40; ages 18-40). These subjects are recruited, screened and diagnosed by collaboration under 95-M-0097, previously approved by IRB entitled An Endocrine Modal for Postpartum Mood Disorders. These subjects will have a history of DSM-IV MDD. Twenty will also have had a hypomanic/manic episode that occurred within three months of childbirth and twenty will have not had the latter within three months of childbirth. Women will have been well for a minimum of one year, have a regular menstrual cycle for at least three months, medication free (including birth control pill), have no history of puerperal suicide attempts or psychotic episodes requiring hospitalization. Any women with a current axis I psychiatric diagnosis will be excluded from participating in this protocol. \n\n HEALTHY FEMALE CONTROLS UNDER 95-M-0097: \n\n (n=20, age 18-40). These healthy control women are under an identical drug administration regimen as the 40 remitted MDD women above and will similarly be recruited and screened under 95-M-0097. They will meet the same criteria specified for the remitted MDD group above but will not have any past or present Axis I diagnosis or evidence of menstrually related mood disorders. This healthy sample of females will have given birth. \n\n ", - "exclusion_criteria": ": \n\n Subjects must not have taken antidepressant or other medications likely to alter monoamine neurochemistry or cerebrovascular function for at least 3 weeks (8 weeks for fluoxetine) prior to scanning. Subjects being scanned at two points or the same point twice in their menstrual cycle must not have taken birth control pills for at least 6 months prior to scanning. However, effective medications will not be discontinued for the purposes of this study. Instead, subjects will be recruited who are not currently receiving psychotropic drugs. Subjects will also be excluded if they have: \n\n serious suicidal ideation or behavior; \n\n psychosis to the extent that the ability to provide informed consent is in doubt; \n\n medical or neurological illnesses likely to affect physiology or anatomy; \n\n a history of drug or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (DSM IV criteria); \n\n current pregnancy \n\n current breast feeding; \n\n general MRI ", - "brief_summary": "The purpose of this study is to evaluate the function of certain brain chemicals and receptors in patients with mood disorders. This study will also examine how the stress hormone cortisol affects brain function.~Data suggest that serotonin 1A (5-HT1A) receptor function is abnormal in patients with mood disorders, such as major depressive disorder (MDD) and bipolar disorder (BP). However, these data are limited because they are based on small sample sizes. In this study, PET scans will be used to compare 5-HT1A receptor binding potential between mood disorder patients and healthy volunteers.~All participants will have an initial medical and psychiatric evaluation. Depression severity, anxiety, negative thinking, level of functioning, intelligence, and cognitive functions will be measured. Urine, saliva, and blood will be collected. Women will have a pregnancy test and tests to determine menstrual phase and time of ovulation. Participants will undergo magnetic resonance imaging (MRI) and PET scans of the brain. Some participants will have other procedures such as a lumbar puncture. Participants with Cushing's disease will undergo imaging as a comparison group.", - "NCTID": "NCT00026832" - }, - { - "brief_title": "Brief Culturally Adapted Cognitive Behaviour Therapy for Depression", - "phase": "", - "drugs": "['Ca CBT']", - "drugs_list": [ - "Ca CBT" - ], - "diseases": "['Depression']", - "diseases_list": [ - "Depression" - ], - "enrollment": "140.0", - "inclusion_criteria": "inclusion criteria: \n\n All those who fulfil the diagnostic criteria of Depressive episode (F32) or Recurrent depressive disorder (F33 except 33.4 ) using ICD10 RDC (based on interviews using SCAN Urdu version), \n\n Are between the ages of 19-60, \n\n Score 8 or more on HADS, Depression Subscale, and \n\n Who live within traveling distance of the psychiatry department will be approached \n\n ", - "exclusion_criteria": ": \n\n Excessive use of alcohol or drugs (using ICD 10 RDC for alcohol or drug abuse or dependence) \n\n Significant cognitive impairment (for example learning disability or dementia) and \n\n Active psychosis", - "brief_summary": "Cognitive behaviour therapy (CBT) has an effective evidence base in the west and is recommended by the national bodies in many countries in the West. Our group has adapted CBT for depression and psychosis in Pakistan for use with local clients. Initial evaluations have found that these therapies are effective. However, due to the financial restraints it would be useful if the investigators find that brief version of the CBT might be applicable and effective in non western cultures. Therefore in this study, the investigators will be testing effectiveness of brief version of culturally adapted CBT for depression in a randomized controlled trial (RCT) in Pakistan.", - "NCTID": "NCT01799551" - }, - { - "brief_title": "E-Compared-CH: Comparative Effectiveness Research on Internet-based Depression Treatment - Swiss Trial", - "phase": "", - "drugs": "['Blended CBT', 'Treatment as usual']", - "drugs_list": [ - "Blended CBT", - "Treatment as usual" - ], - "diseases": "['Depressive Disorder, Major']", - "diseases_list": [ - "Depressive Disorder", - "Major" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Being 18 years of age or older \n\n Meet DSM-IV diagnostic criteria for MDD confirmed by MINI International Neuropsychiatric Interview version 5.0 \n\n Informed Consent \n\n Having access to a PC and Internet connection \n\n Having a Smartphone that is compatible with the mobile component of the intervention \n\n Understanding of the German language spoken and written \n\n ", - "exclusion_criteria": " \n\n Current high risk for suicide according to the MINI Interview section C \n\n Serious psychiatric co-morbidity: substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview \n\n Currently receiving psychological treatment for depression \n\n Being unable to comprehend the spoken and written language (German) \n\n Not having access to a PC and fast Internet connection (i.e. broadband or comparable). \n\n Not having a Smartphone that is compatible with the mobile component of the intervention that is offered or not willing to carry a Smartphone during the duration of treatment", - "brief_summary": "To compare the clinical and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU) in Swiss patients in secondary care", - "NCTID": "NCT02410616" - }, - { - "brief_title": "A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression", - "phase": "Phase 4", - "drugs": "['Duloxetine']", - "drugs_list": [ - "Duloxetine" - ], - "diseases": "['Atypical Depression']", - "diseases_list": [ - "Atypical Depression" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n DSM-IV Major Depression or Dysthymia with Atypical Features \n\n Age 18-65 \n\n Physically healthy \n\n HAMD(24) > 14 \n\n ", - "exclusion_criteria": ": \n\n Prior experience with Duloxetine \n\n History of Psychosis or Bipolar Disorder, Borderline Personality Disorder \n\n Unstable medical disorder; any history of Epilepsy \n\n Currently taking medication that can interact with Duloxetine \n\n Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol) \n\n Serious suicidal ideation judged at least somewhat likely to be acted upon or require hospitalization \n\n Current (past two weeks) use of psychoactive medication (four weeks for Fluoxetine) \n\n Pregnancy \n\n Currently breast feeding \n\n Fecund women failing to use acceptable birth control \n\n Refractory Depression (defined as failure to respond to one or more adequate trials of marketed antidepressants [i.e., >=2/3 PDR maximum dose for at least 4 weeks] during current episode) \n\n Serious suicidal ideation, recent (past six months) suicidal activity, any life-time history of serious suicide attempt (e.g., admitted to ICU, any duration of coma) \n\n Currently taking medication deemed effective", - "brief_summary": "This is a Pilot Study to get a first indication whether Duloxetine may be effective for depressed patients with Atypical Features.", - "NCTID": "NCT00296699" - }, - { - "brief_title": "Study of Supplementation of Antidepressants With Fish Oil to Improve Time to Clinical Response", - "phase": "", - "drugs": "['Omega-3 fatty acid', 'Bovine gelatin capsules']", - "drugs_list": [ - "Omega-3 fatty acid", - "Bovine gelatin capsules" - ], - "diseases": "['Major Depressive Disorder']", - "diseases_list": [ - "Major Depressive Disorder" - ], - "enrollment": "78.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of Major Depressive Disorder. \n\n Allowed comorbidities: Dysthymia, Anxiety Disorders. \n\n 18 years old or older. \n\n Males + Females. \n\n English-speaking. \n\n Women of reproductive age must be on adequate birth control, either oral contraceptives or using condoms or other barrier methods with spermicidal agents. \n\n Subjects may be undergoing psychotherapy, but must maintain current psychotherapy status. Must not start therapy if not already in therapy. If in therapy, must have received at least 6 sessions prior to entering the study. \n\n Subjects may continue taking herbals or supplements during the study, but they may not start any new herbals or supplements during the study. \n\n ", - "exclusion_criteria": ": \n\n 2 or more failed trials of antidepressants (adequate dose and duration, and documented). \n\n Substance dependence in the past 6 months. \n\n Current substance use or abuse (MJ, benzodiazepines, narcotics). If BZD use, patient must be tapered off and wait 1 month before being included in the trial. \n\n Psychosis. \n\n Bipolar Affective Disorder Type I, II or NOS. \n\n Pregnancy (current or planned). \n\n Unstable medical illness (pt has to be stable for at least 3 months, and may be excluded per investigator discretion). \n\n Dementia. \n\n Mental retardation. \n\n Traumatic Brain Injury. \n\n History of Stroke. \n\n History of seizure disorder. \n\n Electroconvulsive therapy within past 6 months. \n\n If, at the investigator's discretion, it is suspected that the subject will likely not comply with the study protocol. \n\n Imminent risk for suicide.", - "brief_summary": "This study will be a randomized controlled trial set in an outpatient clinic, involving patients with major depressive disorder, who will be treated with antidepressant therapy, which will be individually agreed upon by the subject and his or her physician. Patients will be randomized to receive either placebo or fish oil capsules containing eicosapentaenoic acid (EHA) and docosahexaenoic acid (DHA) in addition to their antidepressant medication. Subjects will complete a brief dietary and exercise habits survey at the beginning of the trial to take into account lifestyle factors that may be significant in symptom resolution. Their progress will be monitored over a period of twelve weeks, with standardized rating scales completed by subjects and treating physicians. At the end of the study, scores will be compared between groups to look for differences in timing and degree of symptom improvement to analyze whether improvement occurred faster in the group receiving essential fatty acids (EFAs) than in the one receiving placebo. The primary hypothesis is that supplementation of antidepressant therapy with omega-3 fatty acids will decrease the lag period between the start of therapy and the time of clinically significant symptom improvement. A secondary hypothesis is that the results of this study will be consistent with numerous previous studies showing improvement in symptom control in major depressive disorder when antidepressants are supplemented with omega-3 fatty acids.", - "NCTID": "NCT00963196" - }, - { - "brief_title": "Comparison of Vitamin B12 Supplementation to Selective Serotonin Reuptake Inhibitor (SSRI) Versus SSRI Antidepressant Treatment Alone", - "phase": "", - "drugs": "['Vitamin B12']", - "drugs_list": [ - "Vitamin B12" - ], - "diseases": "['Major Depressive Disorder']", - "diseases_list": [ - "Major Depressive Disorder" - ], - "enrollment": "268.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults between ages 18 to 64 years who meet the criteria for a depressive episode as measured by a score of \u2265 16 on first 17 items of HAM-D (Urdu version. \n\n Patients with low normal B12 levels in serum (>191 but < 300 pg/ml) \n\n Those who will provide informed consent \n\n ", - "exclusion_criteria": ": \n\n Patients with concurrent unstable medical illness \n\n History of manic episodes or psychotic illness \n\n Psychotic symptoms within depressive episode", - "brief_summary": "While treating depression, significant numbers respond poorly to anti-depressants; one cause is vitamin B12 deficiency. The investigators are conducting an open label randomized controlled trial to investigate difference in response to SSRI monotherapy alone versus SSRI and intramuscular B12 replacement in people with low-normal B12 levels. 300 participants will be allocated to each arm of intervention at out patient clinics of the department of Psychiatry at Aga Khan University Hospital, Karachi Pakistan. Baseline and 3 month measurement of depression will be on Hamilton Rating Scale for Depression (Urdu version) and response rates compared.", - "NCTID": "NCT00939718" - }, - { - "brief_title": "Mental Health First Aid for College Students", - "phase": "", - "drugs": "['Mental Health First Aid']", - "drugs_list": [ - "Mental Health First Aid" - ], - "diseases": "['Depression', 'Anxiety', 'Suicidal Ideation', 'Eating Disorders']", - "diseases_list": [ - "Depression", - "Anxiety", - "Suicidal Ideation", - "Eating Disorders" - ], - "enrollment": "2543.0", - "inclusion_criteria": "inclusion criteria: \n\n Student enrolled in a participating campus as a full-time, residential undergraduate during the 2009-2010 or 2010-2011 academic years. Student must have been living in a participating residence hall. \n\n ", - "exclusion_criteria": ": \n\n Students under 18 years of age.", - "brief_summary": "Most college students with mental disorders do not receive treatment, and over 80% of those who die by suicide have never made contact with campus mental health services. Knowledge, stigma, and other health beliefs represent significant barriers to help-seeking for many of these students. However, there have been no large-scale intervention studies for reducing these barriers to mental health treatment on college campuses. This project will fill this gap by determining whether a community mental health education program, Mental Health First Aid (MHFA), is an effective method to increase number of students who seek mental health services on college campuses. MHFA is an international, 12-hour training program that has been shown to increase knowledge of mental illnesses and their treatments, decrease stigma, and increase helping behaviors in community members. However, it has not been tested in a college setting in the United States. To determine the effectiveness of MHFA in US colleges, the proposed project will involve a randomized control trial of the MHFA training program on 32 campuses representing a range of higher education institutions, from community colleges in rural areas to research universities in large, urban areas. The MHFA training program will be administered to peer supports such as residential advisors. Administrative data from campus mental health services and pre- and post-intervention surveys will be used to collect outcome data on service utilization, knowledge, attitudes, and other measures. Data analyses will focus on identifying changes in students' behaviors, knowledge, and attitudes toward mental illnesses that can be attributed to the MHFA training. In addition to testing a novel and timely mental health intervention for college students, this project will result in improved data collection measures for college populations, and will lay the foundation for stronger connections and future collaborations between diverse campus communities. If the MHFA program is successful in reducing stigma and increasing general on-campus awareness and early treatment of emerging mental health problems, then it may provide a cost-effective means for enabling more students to seek early treatments for developing mental health problems.", - "NCTID": "NCT02021344" - } - ] - }, - { - "patient_id": "sigir-20158", - "patient": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", - "0": [ - { - "brief_title": "Neurobehavioral Consequences of Sleep Apnea in Children", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Lung Diseases', 'Sleep Apnea Syndromes']", - "diseases_list": [ - "Lung Diseases", - "Sleep Apnea Syndromes" - ], - "enrollment": "", - "inclusion_criteria": "No eligibility criteria", - "exclusion_criteria": "", - "brief_summary": "To identify physiological and clinical measures of obstructive sleep-disordered breathing that are associated with increased morbidity in children.", - "NCTID": "NCT00006323" - }, - { - "brief_title": "Trans Nasal Insufflation for the Treatment of Snoring", - "phase": "", - "drugs": "['Trans Nasal Insufflation (TNI) [nasal canula]']", - "drugs_list": [ - "Trans Nasal Insufflation (TNI) [nasal canula]" - ], - "diseases": "['Obstructive Sleep Apnea']", - "diseases_list": [ - "Obstructive Sleep Apnea" - ], - "enrollment": "11.0", - "inclusion_criteria": "inclusion criteria: \n\n Consenting adults over the age of 21 \n\n Diagnosed obstructive sleep apnea \n\n ", - "exclusion_criteria": ": \n\n Unstable cardiovascular disease \n\n Uncontrolled hypertension (BP > 190/110) \n\n Severe intrinsic lung diseases (supplemental O2 > 2 L/min during the day) \n\n History of chronic renal insufficiency \n\n History of hepatic insufficiency \n\n Pregnancy \n\n Bleeding disorders or Coumadin use \n\n Sleep Disorders other than Obstructive Sleep Apnea (OSA) \n\n Tracheostomy \n\n Allergy to lidocaine", - "brief_summary": "This research is being done to examine if a nasal cannula can be used to keep the throat open during sleep, thereby treating sleep apnea.~People with sleep apnea and people who snore without sleep apnea may take part in this study. Sleep apnea is a disorder caused by pauses in breathing due to repetitive closure of the throat. The most common form of treatment for sleep apnea is continuous positive airway pressure (CPAP) therapy. While CPAP therapy remains the simplest and most effective treatment for snoring and sleep apnea, patients have to wear a nasal mask throughout the night. For this reason, patients often have difficulty sticking to therapy.~Participants enrolled in this study will spend 3-nights in a sleep laboratory. In all nights, the investigators will monitor your sleep and your breathing throughout the night. The investigators will apply several electrodes (sensors) to your scalp and face to monitor your sleep and breathing, and other sensors to your chest, abdomen, cheek, and a finger to monitor your breathing and oxygen level.", - "NCTID": "NCT00832026" - }, - { - "brief_title": "Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing", - "phase": "", - "drugs": "['SomnaPatch', 'Polysomnography']", - "drugs_list": [ - "SomnaPatch", - "Polysomnography" - ], - "diseases": "['Obstructive Sleep Apnea', 'Central Sleep Apnea', 'Mixed Sleep Apnea', 'Cheyne-Stokes Respiration']", - "diseases_list": [ - "Obstructive Sleep Apnea", - "Central Sleep Apnea", - "Mixed Sleep Apnea", - "Cheyne-Stokes Respiration" - ], - "enrollment": "190.0", - "inclusion_criteria": "inclusion criteria: \n\n Able to understand and sign the informed consent \n\n Able to comply with visits and follow ups included in this protocol \n\n Ages 20-85 years \n\n ", - "exclusion_criteria": ": \n\n An unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related this trial or interferes with the clinical trial and data collection. \n\n Skin rash on the nose or on the maxillary area. \n\n A history of skin allergy to medical tape, and hypoallergenic tapes. \n\n A history of skin cancer on the nose or on the maxillary area. \n\n A history of the base of skull fractures, facial fractures", - "brief_summary": "The purpose of this study is to evaluate the accuracy of Somnarus diagnostic technology for diagnosis of sleep apnea in human subjects. This includes evaluation of Somnarus technology in Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA), including Cheyne - Stokes respiration (CSR).", - "NCTID": "NCT02034175" - }, - { - "brief_title": "Sleep Health in Preschoolers: a Randomized Controlled Trial", - "phase": "", - "drugs": "['SHIP (Sleep Health in Preschoolers)', 'SHIP Control Arm']", - "drugs_list": [ - "SHIP (Sleep Health in Preschoolers)", - "SHIP Control Arm" - ], - "diseases": "['Sleep Initiation and Maintenance Disorders']", - "diseases_list": [ - "Sleep Initiation and Maintenance Disorders" - ], - "enrollment": "500.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 30-71 months \n\n Child behavioral sleep problem, as demonstrated by a score on the Children's Sleep Habits Questionnaire (CSHQ) of at least 50, or a score of 41-49 and reported weeknight sleep of 9hrs or less per night \n\n English speaking parent or guardian \n\n ", - "exclusion_criteria": ": \n\n Sleep disordered breathing, as demonstrated by a score on the CSHQ of at least 5 \n\n Currently taking prescribed sleep medications, psychostimulants, and/or systemic corticosteroids \n\n Serious medical conditions likely to affect sleep, including diabetes or cancer \n\n Major cognitive or developmental disorder, including autism spectrum disorder", - "brief_summary": "The SHIP study is a randomized controlled trial of an intervention for preschool children with sleep problems, in which we aim to give parents the knowledge, motivation, and skills necessary to set goals, problem-solve, and improve their child's sleep. In collecting three years of follow-up data, we will be able to determine the impact of the SHIP intervention on childhood sleep problems, obesity, academic achievement, and emotional and behavioral problems, as well as parental stress and daytime tiredness. This study has the dual potential to expand treatment resources for young children with behavioral sleep problems and to increase our scientific understanding of the long-term consequences of early childhood sleep problems.", - "NCTID": "NCT02255721" - }, - { - "brief_title": "Assessment of Sleep Complaints in Brain Tumor Survivors", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Brain Tumors']", - "diseases_list": [ - "Brain Tumors" - ], - "enrollment": "153.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u22658 to \u2264 18 years of age \n\n Brain tumor survivor \n\n \u22655 years post diagnosis \n\n \u22652 years post active cancer-directed therapy or observation only \n\n Parents speak and read English fluently \n\n Potential participant reads English fluently \n\n Potential participant/guardian willing to sign consent \n\n ", - "exclusion_criteria": ": \n\n Survivor of any cancer other than a brain tumor.", - "brief_summary": "Survivors of pediatric brain tumors are noted to have increased rates of excessive daytime sleepiness. However, very little data are available regarding the specific sleep disturbances of pediatric brain tumor survivors. Children ages 8 to 18 years of age who are at least 5 years from diagnosis and at least 2 years post treatment or observation only for a brain tumor will be targeted to assess the prevalence of sleep complaints.~The study focuses on the following objectives:~To estimate sleep disturbance in a cohort of pediatric brain tumor survivors.~Estimate the rates of parent- and self-reported excessive daytime sleepiness in pediatric brain tumors~Estimate the rates of parent-reported sleep-disordered breathing, including snoring and witnessed apneas, in pediatric brain tumor survivors~Estimate the rates of parent- and self-reported behavioral sleep problems, including nocturnal enuresis, bedtime resistance, nighttime awakenings, nightmares, and fatigue in pediatric brain tumor survivors.~The Study focuses on the following secondary objectives:~To describe bedtime patterns and sleep hygiene of pediatric brain tumor survivors.~Estimate the typical parent- and self-reported weekday sleep duration of pediatric brain tumor survivors~Estimate the typical parent- and self-reported weekend sleep duration of pediatric brain tumor survivors and if it differs from the weekday sleep duration~Estimate the typical parent- and self-reported consistency of sleep hygiene in pediatric brain tumor survivors", - "NCTID": "NCT01102998" - }, - { - "brief_title": "Sleep Disorders in Children With ADHD", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Attention Disorder With Hyperactivity (ADHD)']", - "diseases_list": [ - "Attention Disorder With Hyperactivity (ADHD)" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n - We will compare a group of children with ADHD, other psychiatric disorder, and a healthy group of children age 5 - 10 \n\n ", - "exclusion_criteria": ": \n\n mental retardation -", - "brief_summary": "ADHD is often associated with sleep difficulties. Attention-deficit/hyperactivity disorder (ADHD) is the most common problem presented to children mental health services. The disorder affects approximately 5 % of school-age children. The core symptoms of this disorder include varying degrees of inattention, impulsiveness and restlessness.~In addition to the core symptoms, ADHD is associated with other problems (e.g. academic underachievement, poor social relations and sleep disturbances).~Despite clinical observations of sleep problems in children with ADHD, there is little empirical research on this topic. The prevalence, type of sleep problems, and significance of these sleep disturbances in children with ADHD remain undocumented.~The objective is to determine the relationship of sleep problems to attention deficit/hyperactive disorder, comorbid disorders, and the effect of stimulant treatment.", - "NCTID": "NCT00224731" - }, - { - "brief_title": "Reducing Sleep Disparities in Minority Children", - "phase": "", - "drugs": "['Sleep Counselor Intervention', 'Sleep Education Control']", - "drugs_list": [ - "Sleep Counselor Intervention", - "Sleep Education Control" - ], - "diseases": "['Sleep']", - "diseases_list": [ - "Sleep" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy child age 5-6 years old \n\n School enrollment for a minimum of 5 hours/day \n\n Positive Children's Sleep Habits Questionnaire (score \u2265 41) \n\n Permanent housing for the previous 12 months \n\n Permission for research staff to complete 5-9 home over 1 year \n\n Have telephone access or a contact with telephone access \n\n Fluent in either English or Spanish \n\n ", - "exclusion_criteria": ": \n\n Serious co-morbid condition that may impact sleep including: \n\n genetic syndromes \n\n neuromuscular disorders \n\n seizure disorder \n\n mental retardation \n\n autism \n\n severe learning disabilities \n\n psychiatric disorders \n\n attention-deficit/hyperactivity disorder", - "brief_summary": "Inadequate sleep is a major health problem of childhood that often fails to receive attention until significant neurobehavioral and other health problems are noted. Although adequate sleep is essential for normal growth and brain development, studies show that children from minority and economically disadvantaged families are more likely to experience shorter sleep times and more sleep fragmentation compared to their Caucasian and economically advantaged counterparts. As a result, they are disproportionately affected by the adverse health and quality of life consequences of poor sleep. There are currently no intervention studies to the investigators knowledge aimed at addressing sleep disparities by improving sleep duration and sleep hygiene in early school-aged children from minority populations. This study seeks to close the 'sleep gap' that exists between the sleep duration of minority school-aged children and that of their non-minority peers. An interdisciplinary team of researchers and clinicians from Columbia University's Pediatric Lung and Sleep Disorders Center, School of Public Health, Psychiatry Department, and two outpatient clinic systems affiliated with Columbia are collaborating to reduce sleep disparities by improving sleep duration in a group of 5-6 year old minority children. The primary goal of this study is to evaluate the efficacy of a tailored, interactive, educational and behavioral intervention that utilizes trained sleep counselors to assist parents in improving their children's sleep hygiene and reducing risk factors for poor sleep, thereby increasing sleep duration over a 12-month period in a randomized controlled trial of children identified with sleep problems (Aim 1). The investigators will screen 375 parents of 5-6 year old children from 5 primary care clinics to identify children with and without sleep problems and enroll 90 of the 375 children screened who have sleep problems in a randomized controlled trial of an in-home sleep intervention. Using an initial home assessment, baseline actigraphy data, sleep logs recorded by parents, and information regarding risk factors for poor sleep collected from each family during screening, the investigators will work with intervention parents to develop a personalized sleep plan for their children. The investigators will evaluate the effect of the intervention on: a) nightly sleep duration; b) neurocognitive function; and c) behavioral disorders.", - "NCTID": "NCT01301989" - }, - { - "brief_title": "Diagnosis of Patients With Low or Intermediate Suspicion of SAHS or With Comorbidity: Standard Laboratory Polysomnography Compared With Three Nights of Home Respiratory Polygraphy.", - "phase": "", - "drugs": "['Home Respiratory Polygraphy', 'Standard Polysomnography']", - "drugs_list": [ - "Home Respiratory Polygraphy", - "Standard Polysomnography" - ], - "diseases": "['Obstructive Sleep Apnea Syndrome']", - "diseases_list": [ - "Obstructive Sleep Apnea Syndrome" - ], - "enrollment": "56.0", - "inclusion_criteria": "inclusion criteria \n\n Patients with low or medium suspicion of Sleep Apnea \n\n Patients with notorious comorbidity \n\n Age between 18 and 75 years \n\n Capability to fill in written questionnaires \n\n ", - "exclusion_criteria": " \n\n Patients with high suspicion of sleep apnea \n\n Serious heart disease, resistant systemic hypertension, Suspicion of non-apneic sleep disorders, such as narcolepsy, REM behavior disorders and restless leg syndrome. \n\n Patients with diagnosis of SAHS \n\n Lack of informed consent.", - "brief_summary": "Study Objectives: Obstructive sleep apnea (OSA) diagnosis using simplified methods such as home respiratory polygraphy (HRP) is only recommended in patients with a high pre-test probability. The aim is to determine the diagnostic efficacy, therapeutic decision-making and costs of OSA diagnosis using PSG or three consecutive studies of HRP in patients with mild-moderate suspicion of sleep apnea or with co-morbidity that can mask OSA symptoms.~Design and Setting: Randomized, blinded, crossover study of three nights of HRP (3N-HRP) vs. PSG. The diagnostic efficacy was evaluated with ROC curves. Therapeutic decisions to assess concordance between the two different approaches were analyzed by sleep physicians and respiratory physicians (staff and residents) using agreement level and kappa coefficient. The costs of each diagnostic strategy were considered.", - "NCTID": "NCT01820156" - }, - { - "brief_title": "Efficacy of Telemonitoring on CPAP Treatment Compliance in Obstructive Sleep Apnea (OSA) Patients", - "phase": "", - "drugs": "['Standard follow-up', 'Telemonitoring']", - "drugs_list": [ - "Standard follow-up", - "Telemonitoring" - ], - "diseases": "['Sleep Apnea Syndrome']", - "diseases_list": [ - "Sleep Apnea Syndrome" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Men and Women over 18 years old \n\n Diagnosed as OSA and requiring CPAP treatment \n\n Written informed consent form signed. \n\n ", - "exclusion_criteria": ": \n\n Patients with impaired lung function (overlap syndrome, obesity hypoventilation syndrome, and restrictive disorders) \n\n Severe heart failure \n\n Severe chronic pathology associated \n\n Psychiatric disorder \n\n Periodic leg movements \n\n Pregnancy \n\n Other dyssomnias or parasomnias \n\n Patients already treated with CPAP", - "brief_summary": "The purpose of this study is to compare the effectiveness of telemonitoring versus standard follow-up on CPAP treatment compliance in Obstructive Sleep Apnea Syndrome (OSAS).", - "NCTID": "NCT02517346" - }, - { - "brief_title": "Sleep, Mood, and Behavior Study", - "phase": "", - "drugs": "['Cognitive Behavioral Therapy-Sleep']", - "drugs_list": [ - "Cognitive Behavioral Therapy-Sleep" - ], - "diseases": "['Sleep Difficulties in Pediatric Anxiety Disorder', 'Generalized Anxiety Disorder', 'Separation Anxiety Disorder', 'Social Phobia']", - "diseases_list": [ - "Sleep Difficulties in Pediatric Anxiety Disorder", - "Generalized Anxiety Disorder", - "Separation Anxiety Disorder", - "Social Phobia" - ], - "enrollment": "51.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), and Social Phobia (SP) \n\n Previous enrollment Cognitive Behavioral Therapy arm in ClinicalTrials.gov Identifier: NCT00774150 study, entitled, Transdisciplinary Studies of CBT for Anxiety in Youth: Child Anxiety Treatment Study (CATS) \n\n The child/adolescent must have a sleep problem defined as: difficulties at least 3 times within a 2-week period in one or more of the following domains: \n\n difficulties going to sleep \n\n difficulties waking during the night \n\n difficulties getting up on time for school because of tiredness/sleepiness \n\n daytime tiredness and/or irritability that the child or parent attributed to insufficient sleep \n\n erratic sleep-wake schedules \n\n ", - "exclusion_criteria": ": \n\n IQ below 70 as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI). \n\n Requires current ongoing treatment with psychoactive medications including anxiolytics and antidepressants. \n\n Acutely suicidal or at risk for harm to self or others. \n\n Any motor impairments or eye-hand coordination problems \n\n Sleep disorder or parasomnia. \n\n Taking any medication that might interfere with sleep. \n\n Has a medical problem that might interfere with sleep.", - "brief_summary": "The purpose of this study is to assess whether improving sleep in children and adolescents with anxiety disorder will further enhance affective, clinical, and social functioning.", - "NCTID": "NCT00787397" - }, - { - "brief_title": "A Study to Examine the Relationship Between Sleep Apnea and Cleft Lip/Palate", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Obstructive Sleep Apnea Syndrome', 'Cleft Lip/Palate']", - "diseases_list": [ - "Obstructive Sleep Apnea Syndrome", - "Cleft Lip/Palate" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n 100 children with cleft lip/palate and signs and symptoms of OSAS, parents who can read and write English \n\n ", - "exclusion_criteria": ": \n\n Parents who cannot read and write English, children with severe neurological compromise", - "brief_summary": "The study is to examine the relationship between sleep apnea and neurocognitive behaviors in children with cleft lip/palate. Describe the incidence and severity of obstructive sleep apnea in an unselected population of grade school aged children with surgically repaired cleft palate.~A. Is the incidence of OSA higher in children with cleft palate than age matched historical control groups? B. Are nighttime symptoms an adequate screening tool to exclude the diagnosis of OSA in children with surgically repaired cleft palate? Describe the velopharyngeal closure patterns during speech in an unselected population of grade school aged children with surgically repaired cleft palate. Describe the neurobehavioral phenotype of an unselected population of grade school aged children with surgically repaired cleft palate.", - "NCTID": "NCT00156442" - }, - { - "brief_title": "New Markers to Measure Clotting in Patients With the Obstructive Sleep Apnoea Hypopnoea Syndrome", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Obstructive Sleep Apnoea Hypopnoea Syndrome', 'Biomarkers of Fibrin Clot Structure', 'Biomarkers of Vascular Endothelial Injury']", - "diseases_list": [ - "Obstructive Sleep Apnoea Hypopnoea Syndrome", - "Biomarkers of Fibrin Clot Structure", - "Biomarkers of Vascular Endothelial Injury" - ], - "enrollment": "66.0", - "inclusion_criteria": "inclusion criteria: \n\n 18-80 year old with h/o daytime sleepiness, snoring and apnoeas \n\n ", - "exclusion_criteria": ": \n\n Refusal to give written informed consent. \n\n Personal or family history of pro- thrombotic or bleeding disorders, severe liver disease (clotting problems) and those prescribed warfarin or heparin. \n\n Those with borderline sleep studies (4% Diprate or AHI 10-14 per hour). \n\n Aged less than 18 years or greater than 80 years.", - "brief_summary": "Obstructive Sleep Apnoea Hypopnoea Syndrome(OSAHS)affects at least 4% of males and 2% of females.~OSAHS is the combination of excessive daytime sleepiness, snoring and apnoeas (stopping breathing at night). As well as affecting tiredness, mood, concentration and quality of life - there is growing concern that it can increase the risk of high blood pressure, heart problems, strokes and thromboses (clots in the veins).~It appears that OSAHS may affect the thickness of the blood and cause it to clot more easily it also causes damage to the lining of the blood vessels (endothelial injury). These effects seem independent of other risk factors such as obesity, smoking, family history of clots etc.~The investigators are testing new biomarkers: gel point and fractal dimension developed at the Swansea University to measure the 'clotting' of the blood in people with OSAHS and a similar group of people who snore and who are sleepy but do not have OSAHS on sleep studies (Controls) Also markers of vascular inflammation are being measured.", - "NCTID": "NCT01525160" - }, - { - "brief_title": "Regulation of Vascular Thrombosis in Sleep Apnea", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Obstructive Sleep Apnea']", - "diseases_list": [ - "Obstructive Sleep Apnea" - ], - "enrollment": "14.0", - "inclusion_criteria": "inclusion criteria: \n\n 21 years or older \n\n Patient of the Weill Cornell Pulmonary Associates and Cornell Center for Sleep Medicine practices \n\n Clinically indicated for an overnight sleep study within six months prior to or after the outpatient office visit \n\n ", - "exclusion_criteria": ": \n\n Pregnancy", - "brief_summary": "Sleep Apnea is a prevalent condition that has been increasingly diagnosed in the adult population and is now considered an independent risk factor for the development of cardiovascular disease. A better understanding of the mechanisms associated with the development of cardiovascular disease in sleep apnea is needed.~This research will investigate the function of the adenosine deaminase (ADA) in subjects with sleep disorders. This enzyme is responsible for metabolizing adenosine, a neuromodulator that is released during periods of sleep apnea and that has been found to promote vascular thrombosis. There are multiple types of ADA that are genetically determined and have different levels of function. Those different forms of this enzyme may determine groups that are more susceptible to the development of thrombosis. Given the known association between sleep apnea and thrombosis, this study will determine if polymorphisms of this enzyme are differentially found in subjects with sleep apnea as compared to other sleep disturbances. The overall objective of this experiment is to assess the presence of ADA polymorphisms in sleep apnea.", - "NCTID": "NCT00859690" - }, - { - "brief_title": "European Sleep Apnea and Sudden CArdiac Death ProjEct", - "phase": "", - "drugs": "['Positive Airway Pressure Therapy']", - "drugs_list": [ - "Positive Airway Pressure Therapy" - ], - "diseases": "['Sleep Apnea', 'Sudden Cardiac Death', 'Heart Failure', 'Ischemic Cardiomyopathy']", - "diseases_list": [ - "Sleep Apnea", - "Sudden Cardiac Death", - "Heart Failure", - "Ischemic Cardiomyopathy" - ], - "enrollment": "900.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with ICM indicated for ICD/CRT-D implant based on current ESC Guidelines for primary prevention of sudden cardiac death \n\n ", - "exclusion_criteria": ": \n\n Previously diagnosed sleep apnea CPAP, BiPAP or ASV treatment \n\n Patients with previously implanted ICD/CRT-D device indicated for device replacement \n\n Uncontrolled hypertension \n\n Severe valvular heart disease/dysfunction with exception of ischemic and functional mitral regurgitation \n\n Acute coronary syndrome or acute cardiac decompensation in 4 weeks before ICD/CRT-D implant \n\n Expected indication of heart transplant in period of 12 months or less after ICD/CRT-D implant \n\n Expected cardiac surgery or percutaneous coronary intervention in period of 12 months or less after ICD/CRT-D implant \n\n Severe pulmonary diseases \n\n Rejection of participation in the study \n\n Pregnancy \n\n Age of 80 years and higher in time of ICD/CRT-D implant", - "brief_summary": "The objective of ESCAPE-SCD Study is assessment of the effect of sleep apnea on sudden cardiac death risk and cardiovascular outcomes in patients with ischemic cardiomyopathy. The ESCAPE - SCD Study will address following specific study questions:~Is obstructive sleep apnea (OSA) and/or central sleep apnea (CSA) an independent risk factor of sudden cardiac death (SCD) in patients with ischemic cardiomyopathy (ICM) indicated for ICD/CRT-D implant based on current European Society of Cardiology (ESC) Guidelines for primary prevention of sudden cardiac death?~Can treatment of predominant (>50%) obstructive sleep apnea by appropriate Positive Airway Pressure (PAP) therapy decrease risk of sudden cardiac arrhythmic death in ICM patients?~Can treatment of predominant (>50%) obstructive sleep apnea by appropriate PAP therapy improve cardiovascular outcomes in ICM patients indicated for ICD/CRT-D implant?~Does obstructive sleep apnea represent a novel factor that may improve risk stratification of sudden cardiac death and advance identification of those patients that will benefit from ICD/CRT-D therapy?", - "NCTID": "NCT02506166" - }, - { - "brief_title": "Effect of Nasal Continuous Positive Airway Pressure (CPAP) Blood Pressure and Vascular Endothelial Growth Factor in Obstructive Sleep Apnea Syndrome", - "phase": "", - "drugs": "['Continuous positive airway pressure (CPAP)', 'Sham Continuous positive airway pressure (CPAP)']", - "drugs_list": [ - "Continuous positive airway pressure (CPAP)", - "Sham Continuous positive airway pressure (CPAP)" - ], - "diseases": "['Obstructive Sleep Apnea']", - "diseases_list": [ - "Obstructive Sleep Apnea" - ], - "enrollment": "140.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 20 to 80 yrs \n\n Apnea hypopnea index (AHI) > 10/hr on Polysomnograph (PSG) with symptoms of obstructive sleep apnea (OSA) as described previously \n\n Epworth Sleepiness Scale (ESS) >10 \n\n Patients with hypertension will still be eligible to enter and continue the study as long as there is no alteration of anti-hypertensive medications during the study period \n\n ", - "exclusion_criteria": ": \n\n Patients having problems staying awake during driving, shift work \n\n Recent myocardial infarction \n\n Unstable angina \n\n Underlying malignancy", - "brief_summary": "Sleep-disordered breathing (SDB) briefly means cessation of breathing during sleep at least 5 times per hour. SDB is a common disorder affecting 9 to 24% of the middle-aged and overall 4% of the middle-aged male population suffers from the Obstructive sleep apnea syndrome (OSA) i.e. Sleep-disordered breathing (SDB) with associated daytime sleepiness. Several major epidemiological studies have shown that SDB is not only an independent risk factor for hypertension but it is also strongly associated with heart failure and stroke. The mechanism for the linkage between SDB and cardiovascular consequences is not fully determined. Vascular endothelial growth factor (VEGF) is a soluble 34-46 kD angiogenic heparin-binding glycoprotein. This cytokine regulates multiple endothelial cell functions including vascular permeability and vascular tone and some data suggest that it may contribute to the atherosclerotic process. Recent studies have shown increased plasma and serum concentrations of Vascular endothelial growth factor (VEGF) in patients with OSA and there were correlations between VEGF concentrations and the severity of OSA, as indexed by the minimum oxygen saturation level and the frequency of the upper airway obstruction per hour of sleep. A recent non-randomized study with a small sample size has shown a significant decrease in Vascular endothelial growth factor (VEGF) concentrations in patients in whom nocturnal hypoxia improved after 1 year of nasal continuous positive airway pressure (CPAP) therapy.~Despite robust evidence showing improvement of symptoms, cognitive function and quality of life in obstructive sleep apnea (OSA) patients treated with nasal CPAP, there are nevertheless conflicting data whether Continuous positive airway pressure (CPAP) can reduce daytime blood pressure (BP) in patients with OSA. Two randomized placebo controlled studies have shown reduction of 24-hr systolic and diastolic blood pressure (BP) in obstructive sleep apnea (OSA) patients after 1 month of nasal continuous positive airway pressure (CPAP) therapy while other investigators have shown no such benefit.~This randomized, sham-placebo controlled study aims to assess 1) the effect of nasal continuous positive airway pressure (CPAP) over a period of 3 months on 24 hr blood pressure (BP); and 2) whether any change in BP and plasma Vascular endothelial growth factor (VEGF) is related to the baseline severity of obstructive sleep apnea (OSA) and continuous positive airway pressure (CPAP) compliance.", - "NCTID": "NCT00300872" - }, - { - "brief_title": "Comparison Of The Berlin Questionnaire To The Portland Sleep Quiz", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Sleep Apnea']", - "diseases_list": [ - "Sleep Apnea" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults more than 18 years old \n\n ", - "exclusion_criteria": ": \n\n Subjects Unwilling to Complete the Questionnaire", - "brief_summary": "This trial is enrolling patients who are already being seen at OHSU sleep disorder center or have been referred for clinical reasons by their physician to the OHSU sleep disorder center and are going to have a sleep study that would be paid for by their insurance company for clinical reasons.~The purpose of this study is to determine whether the Portland sleep apnea quiz has a higher specificity and negative predictive value then the Berlin Sleep Questionnaire in a patient population with a high predisposition to sleep apnea presenting to a sleep center.", - "NCTID": "NCT01269073" - }, - { - "brief_title": "Sleep Apnoea Syndrome Without Chronic Heart Failure", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Sleep Apnoea Syndrome']", - "diseases_list": [ - "Sleep Apnoea Syndrome" - ], - "enrollment": "26.0", - "inclusion_criteria": "inclusion criteria: \n\n patients with supected sleep apnoea syndrome and scheduled diagnosis at a sleep laboratory \n\n male and female patients aged at least 18 years \n\n persons who understand and follow the instructions of the study staff \n\n singed informed consent \n\n ", - "exclusion_criteria": ": \n\n persons being housed in an institution by court or governmental order \n\n pregnancy or breastfeeding \n\n patients who are not able to consent \n\n acute or chronic inflammations of the external and middle auditory canal \n\n abnormal anatomic proportionsof the external and middle auditory canal which are pathological or congenital, for example limitation of the auditory canal \n\n persons in a dependence or in an employment contract to the investigator \n\n participation in another study at the same time", - "brief_summary": "It is the objective of this study to collect scientific data of sleep apnoea syndrome patients\u00b4 cardiac and respiratory function by additional sensors.", - "NCTID": "NCT01775241" - }, - { - "brief_title": "Sleep Apnea Screening", - "phase": "", - "drugs": "['Berlin and Epworth questionaries', 'Sleep apnea monitoring in those patients in whom a pacemaker with monitoring apnea system has been implanted.', 'Night polygraph / Polysomnography']", - "drugs_list": [ - "Berlin and Epworth questionaries", - "Sleep apnea monitoring in those patients in whom a pacemaker with monitoring apnea system has been implanted.", - "Night polygraph / Polysomnography" - ], - "diseases": "['Sleep Apnea/Hypopnea Syndrome']", - "diseases_list": [ - "Sleep Apnea/Hypopnea Syndrome" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 years or older \n\n No previous diagnosis of sleep apnea \n\n Fulfilling at least one of the following: \n\n Pacemaker indication \n\n ICD or CRTD therapy indication \n\n Heart failure and preserved LVEF (40-50%) \n\n Heart failure and reduced LVEF (<40%) \n\n Signed informed consent \n\n ", - "exclusion_criteria": ": \n\n Age younger than 18 years \n\n Renal hemodialysis \n\n Cardiac transplant indication \n\n Women who are pregnant \n\n Advanced cancer \n\n Enrollment in another investigational study \n\n Able and willing to comply with all testing and requirements \n\n Patient not suitable for inclusion due to psychiatric conditions or short life expectancy", - "brief_summary": "To assess the incidence of Sleep Apnea-Hypopnea Syndrome (SAHS), both obstructive and central, in patients with: 1) pacemaker indication; 2) implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRTD), 3) heart failure and preserved left ventricular ejection fraction (LVEF) and 4) heart failure and reduced LVEF.", - "NCTID": "NCT02569749" - }, - { - "brief_title": "Prognostic Impact of Sleep Apnea on Cardiovascular Morbidity and Mortality, in End Stage Renal Disease Patients", - "phase": "", - "drugs": "['No Sleep Apnea', 'Sleep Apnea - untreated', 'Sleep Apnea - treated']", - "drugs_list": [ - "No Sleep Apnea", - "Sleep Apnea - untreated", - "Sleep Apnea - treated" - ], - "diseases": "['Obstructive Sleep Apnea', 'End Stage Renal Disease']", - "diseases_list": [ - "Obstructive Sleep Apnea", - "End Stage Renal Disease" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n end stage renal disease on renal replacement therapy \n\n age \u2265 18 years \n\n ", - "exclusion_criteria": ": \n\n unstable congestive heart failure \n\n active psychiatric disease", - "brief_summary": "The purpose of this study is to prospectively evaluate the impact of sleep apnea on the cardiovascular morbidity and mortality of patients with end-stage renal disease.", - "NCTID": "NCT02073305" - }, - { - "brief_title": "Effect of Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea on Resistant Hypertension", - "phase": "", - "drugs": "['continuous positive airway pressure']", - "drugs_list": [ - "continuous positive airway pressure" - ], - "diseases": "['Resistant Hypertension', 'Obstructive Sleep Apnea']", - "diseases_list": [ - "Resistant Hypertension", - "Obstructive Sleep Apnea" - ], - "enrollment": "92.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 - 65 \n\n known hypertension on \u2267 3 anti-hypertensive drugs \n\n Apnea-hypopnea index \u226715 \n\n able to give informed written consent \n\n ", - "exclusion_criteria": ": \n\n moderate renal impairment (glomerular filtration rate <30 mL/min/m2 ) \n\n endocrine/renal/cardiac causes of secondary HT \n\n congestive heart failure and clinically fluid overloaded \n\n On drugs that elevates BP e.g. NSAID, steroid \n\n Non-compliance to anti-hypertensive medications \n\n Unstable medical conditions such as unstable angina, recent myocardial infarction/stroke within 3 months \n\n Active inflammatory/infective conditions e.g. rheumatoid arthritis \n\n Excessive sleepiness that can be risky e.g. occupational driver, machine operator \n\n Modification/changes of anti-hypertensive regimen within 8 weeks", - "brief_summary": "The objectives of this study are to investigate the effect of continuous positive airway pressure (CPAP) treatment on blood pressure control and vascular inflammation in subjects with resistant hypertension and moderate obstructive sleep apnea (OSA).", - "NCTID": "NCT00881985" - }, - { - "brief_title": "Understanding Sleep Problems in Children With Autism Spectrum Disorder", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Sleep Problems']", - "diseases_list": [ - "Sleep Problems" - ], - "enrollment": "58.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of Autism Spectrum Disorder; supported by ADOS and the ADI or SCQ (subjects). \n\n Age greater than or equal to 4 or less than or equal to 9 years; \n\n Parents have given informed consent. \n\n Parent/Caregiver fluent in written and spoken English. \n\n Controls only: A SCQ score of less than 10 without parental or physician concern for another neurodevelopmental disorder will be used to define normal children. \n\n ", - "exclusion_criteria": ": \n\n Current use of psychoactive medications (e.g. fluoxetine, methylphenidate, risperidone, lithium, etc.)*; \n\n Current or use within the last 1 month of beta-blockers or melatonin; \n\n Current use of sleep aids; \n\n Presence of untreated medical problems that could otherwise explain sleep problems (e.g. obstructive sleep apnea, gastroesophageal reflux disease - GERD); \n\n Blindness. \n\n Controls only: current or past diagnosis of ADHD, depression, anxiety or with any other psychiatric conditions. (7) Controls only: Sibling has a diagnosis of Autism Spectrum Disorder. \n\n Psychoactive medications can be discontinued but the parents must discuss medication discontinuation with their prescribing physician prior to reducing or stopping the medications.", - "brief_summary": "The investigators will examine whether sleep problems in children with autism spectrum disorder (ASD) are related to alterations in the production of melatonin (MT), a hormone that plays an important role in regulating sleep-wake cycle. Children with ASD experience high rates of sleep disturbances that potentially contribute to problems with thinking and behavior. It is unclear if changes in MT production cause sleep problems in children with ASD. MT is frequently used to treat these sleep problems; however, it has not been well established whether MT is an effective treatment. Our hypotheses concerning MT is children with ASD and sleep problems will have a delayed sleep-wake cycle and/or decreased MT production. This study will compare children diagnosed with ASD to healthy control children with no ASD diagnosis. All subjects will be recruited from one of three sites: Baylor College of Medicine, Oregon Health & Science University and Columbia University. The investigators will use a standardized questionnaire to determine whether the child has sleep problems. The investigators will measure MT levels in saliva in ASD children with sleep problems and in a group of control children without sleep problems. Total 24-hour MT production will be determined from urine samples in these same two groups.", - "NCTID": "NCT00691080" - }, - { - "brief_title": "Effect of Bariatric Surgery on Obstructive Sleep Apnea in a Danish Cohort", - "phase": "", - "drugs": "['bariatric surgery']", - "drugs_list": [ - "bariatric surgery" - ], - "diseases": "['Obstructive Sleep Apnoea (OSA)']", - "diseases_list": [ - "Obstructive Sleep Apnoea (OSA)" - ], - "enrollment": "56.0", - "inclusion_criteria": "inclusion criteria: \n\n BMI > 35 \n\n attending bariatric surgery \n\n ", - "exclusion_criteria": ": \n\n retrognathia \n\n micrognathia, \n\n acromegaly \n\n downs syndrome", - "brief_summary": "Studies have shown high prevalence (60-94%) of obstructive sleep apnoea (OSA) among patients undergoing bariatric surgery.~Fifteen studies are published investigating the effect of bariatric surgery on OSA. All of them conclude a highly positive effect on OSA by bariatric surgery and weight loss. However these studies are biased by a huge number of drop outs. The drop out rate in the studies are around 60 percent.~The Investigators state that the prevalence of OSA among patients undergoing bariatric surgery in Denmark is high. The Investigators state that the effect of bariatric surgery is significant on severity of OSA. The Investigators state that we can perform a study without a huge number of dropouts.", - "NCTID": "NCT02012868" - }, - { - "brief_title": "Obstructive Sleep Apnoea and Adipose Tissue Dysfunction", - "phase": "", - "drugs": "['Continuous positive airway pressure devices']", - "drugs_list": [ - "Continuous positive airway pressure devices" - ], - "diseases": "['Obstructive Sleep Apnoea', 'Obesity', 'Hypoxia']", - "diseases_list": [ - "Obstructive Sleep Apnoea", - "Obesity", - "Hypoxia" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria: \n\n men with or without obstructive sleep apnoea \n\n ", - "exclusion_criteria": ": \n\n weight loss interventions \n\n steroid use \n\n active smoking", - "brief_summary": "Dysfunctional adipose tissue predisposes to cardiovascular disease. Similarly, the risk of cardiovascular disease appears to be increased in subjects with obstructive sleep apnoea. Reduced adipose tissue oxygen availability has been described in obesity and may also be a mechanism in obstructive sleep apnoea. Hypoxia induces inflammation and fibrosis in adipose tissue which are factors contributing to cardiovascular risk. The investigators hypothesize that adipose tissue's oxygen uptake is reduced in subjects with obstructive sleep apnoea by comparing in vivo AT oxygenation and blood flow in tissue of control subjects.", - "NCTID": "NCT02518633" - }, - { - "brief_title": "The SNORES Randomized Clinical Trial", - "phase": "", - "drugs": "['Screening for obstructive sleep apnea', 'CPAP - continuous positive airway pressure']", - "drugs_list": [ - "Screening for obstructive sleep apnea", - "CPAP - continuous positive airway pressure" - ], - "diseases": "['PCOS', 'Sleep Apnea']", - "diseases_list": [ - "PCOS", - "Sleep Apnea" - ], - "enrollment": "4.0", - "inclusion_criteria": "inclusion criteria \n\n Females 18 - 50 years old. \n\n Receiving care from an Obstetrician / gynecologist or a Reproductive endocrinology infertility specialist \n\n Polycystic ovarian syndrome defined by the modified Rotterdam criteria \n\n Able to speak and understand as well as give informed consent in English \n\n ", - "exclusion_criteria": " \n\n Late onset congenital adrenal hyperplasia \n\n Cushings disease \n\n Androgen-secreting tumors \n\n Previous diagnosis of obstructive sleep apnea \n\n Current use of over the counter or prescribed sleep medications. \n\n Examples of medications that exclude a patient from this study include but are not limited to Unisom, Ambien or Lunesta. \n\n Patients who are taking non-prescribed herbal medications for sleep will not be excluded from the study. Examples of these include but are not limited to melatonin, chamomile, or valerian. \n\n Untreated thyroid disease \n\n Prolactin excess \n\n Patients with the following medical conditions will be excluded from the study as portable sleep apnea monitors are not indicated in patients with severe pulmonary disease, neuromuscular disease, or congestive heart failure.", - "brief_summary": "Randomized clinical trial among women with polycystic ovary syndrome (PCOS) who present for fertility treatment to evaluate the impact of screening for obstructive sleep apnea.", - "NCTID": "NCT02442999" - }, - { - "brief_title": "Continuous Transcutaneous Electrical Stimulation in Sleep Apnoea", - "phase": "", - "drugs": "['Transcutaneous electrical stimulation', 'Sham stimulation']", - "drugs_list": [ - "Transcutaneous electrical stimulation", - "Sham stimulation" - ], - "diseases": "['Obstructive Sleep Apnoea']", - "diseases_list": [ - "Obstructive Sleep Apnoea" - ], - "enrollment": "44.0", - "inclusion_criteria": "inclusion criteria: \n\n males and females, age >18years and <75years, body-mass index (BMI) >18 and <40kg/m2, non-smokers, sleep apnoea with an ODI \u226515/h or sleep apnoea with an ODI \u22655/h plus an Epworth sleepiness score >10. \n\n ", - "exclusion_criteria": ": \n\n morbid obesity (BMI>40kg/m2) or cachexia (BMI<18kg/m2), obesity-hypoventilation syndrome (total sleep time with oxygen saturation (SpO2) less than 90% of more than 10% of the night), active smokers or smoking history of >20pack years, acute or critical illness, acute psychosis or chronic mental disorder affecting capacity, previous home-mechanical non-invasive ventilation and metal implants in the upper part of the body (this excludes dental implants).", - "brief_summary": "The aim of this randomized, double-blinded, sham-controlled cross-over trial is to demonstrate the effectiveness of continuous transcutaneous electrical stimulation of the pharyngeal dilator muscles to reduce sleep-disordered breathing.", - "NCTID": "NCT01661712" - }, - { - "brief_title": "Acromegaly & Sleep Apnoea", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Acromegaly']", - "diseases_list": [ - "Acromegaly" - ], - "enrollment": "653.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults aged 16 and above. \n\n Referred to the Sleep Apnoea Clinic for assessment of obstructive sleep apnoea \n\n Have capacity to given informed consent. \n\n ", - "exclusion_criteria": ": \n\n Patients under 16 years of age \n\n Not referred to the Sleep Apnoea Clinic \n\n Unable to give informed consent", - "brief_summary": "Estimates of the prevalence of acromegaly, a condition resulting from excess growth hormone secretion, are as high as 1:1000. If detected late acromegaly increases the risk of joint destruction, heart disease, sleep apnoea, high blood pressure, diabetes, and polyps in the colon. To have a greater effect on long-term outcomes this disease needs to be detected early. By screening a 'high risk' population (sleep apnoea clinic) the investigators may be able to detect these patients earlier and prevent late complications of the disease. At LTHT the referral pathway for new referrals to the sleep apnoea clinic involves initial attendance to pick up a pulse oximeter to wear overnight to measure oxygen levels. These readings show approximately 1:4 patients displays evidence of significant obstructive sleep apnoea to warrant referral to the treatment group for continuous positive airway pressure (CPAP), weight management, and occasionally mandibular adjustment.~Patients attending the sleep apnoea clinic either as new referral or for review will be asked to participate in the proposed study. The study is cross-sectional in design incorporating two sub-populations within the sleep apnoea clinic. The first cohort comprises patients under follow-up known to have sleep apnoea, and the second cohort those patients prospectively attending the sleep apnoea clinic for assessment. If after an explanation of the study they agree to participate blood will be taken for assessment of IGF-I and they will be asked to complete a simple questionnaire.~The aim will to be to screen 1000 consecutive patients. The questionnaire will incorporate five simple questions to be completed with a 'yes' or 'no' answer. Where IGF-I levels are elevated patients will be investigated further for the possibility of acromegaly. The presence of biochemically proven acromegaly will be used to determine if the simple question has sufficient sensitivity to use as a screening tool.", - "NCTID": "NCT02371057" - }, - { - "brief_title": "Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's Disease", - "phase": "Phase 4", - "drugs": "['ROZEREM', 'Ramelteon']", - "drugs_list": [ - "ROZEREM", - "Ramelteon" - ], - "diseases": "[\"Parkinson's Disease\"]", - "diseases_list": [ - "Parkinson's Disease" - ], - "enrollment": "4.0", - "inclusion_criteria": "inclusion criteria: \n\n 45-85 years of age and living in the community \n\n Male or female of non-child bearing potentials (non-child bearing is defined as at lease 6 months post-menopause or surgically sterile) \n\n Must have a diagnosis of Parkinson's disease \n\n Must have complaints of sleep disturbance \n\n ", - "exclusion_criteria": ": \n\n Patients with diagnosis of or those meeting DSM-IV criteria for major depression, schizophrenia or schizoaffective disorder, bipolar disorder, substance abuse disorder, other mental illness that is known to contribute to sleep disturbance, epilepsy, other medical conditions that are known to cause or contribute to sleep disturbances \n\n Patients currently using melatonin or ramelteon, hypnotics, benzodiazepines, antidepressants, blood-brain barrier permeable beta blockers, steroids, antipsychotics \n\n Patients with clinically significant blood or urine abnormalities \n\n Patients who have taken any investigational drug less than 1 month prior to the baseline visit \n\n Patients with multiple concomitant disorders with or without medications thought to produce sleep disturbances \n\n Patients with pre-existing sleep disturbances unrelated to Parkinson's disease \n\n Patients with severe hepatic impairment (Child-Pugh Class C) \n\n Patients with severe COPD (those with elevated pCO2 levels or those needing nocturnal oxygen therapy \n\n Patients with severe sleep apnea \n\n Patients who have sensitivity to ramelteon or any constituents of the Rozerem preparation \n\n Patients taking rifampin or potent inducers of CYP1A2, CYP3A4, CYP2C9 (ketoconazole, fluconazole) \n\n Patients living in a nursing home. Those living in assisted living facilities and board and care facilities may be included \n\n Patients unable to comply with the study protocol", - "brief_summary": "Patients with Parkinson's disease represent a significant proportion of VA elderly patients. Sleep disturbances and caregiver burnout association with this condition represent a significant problem. In this study, the investigators propose to perform an evaluation of a fixed doe of ramelteon on sleep in VA outpatients diagnosed with Parkinson's disease.~The hypothesis to be examined is that ramelteon will improve the quality of sleep in patients with Parkinson's disease while indirectly improving the quality of life for the patients and caregivers. The investigators further hypothesize that these changes will occur through restructuring and normalization of the sleep architecture.", - "NCTID": "NCT00462254" - }, - { - "brief_title": "Mometasone Furoate on Sleep Disturbances in Subjects With Seasonal Allergic Rhinitis (Study P04608) (COMPLETED)", - "phase": "Phase 4", - "drugs": "['Mometasone Furoate Nasal Spray (MFNS)', 'Placebo']", - "drugs_list": [ - "Mometasone Furoate Nasal Spray (MFNS)", - "Placebo" - ], - "diseases": "['Seasonal Allergic Rhinitis']", - "diseases_list": [ - "Seasonal Allergic Rhinitis" - ], - "enrollment": "401.0", - "inclusion_criteria": "inclusion criteria: \n\n Must be >=18 years of age and older, of either sex, and of any race. \n\n Clinically symptomatic at Screening (Day -7 to -4)and at Baseline (Day 1) \n\n At Screening Visit, must have complaints of sleep disturbance while symptomatic with seasonal allergic rhinitis (SAR) and must have a score of 30 or greater for the Sleep Disturbance Sleep Scale (items 1,3,7 and 8) \n\n At the Baseline Visit, must have complaints of sleep disturbance and daytime somnolence while symptomatic with SAR and with a score of 30 or greater for the Sleep Problems Index II (SLP9) and 30 or greater for the Daytime Somnolence Sleep Scale (items 6, 9, and 11) \n\n Must have a 2-year or longer history of SAR occurring during the same season as the current study. \n\n Must have skin tests positive for outdoor allergens common in subjects with SAR prevalent during the time of this study, such as, trees, grasses, weeds, ragweed, and molds. The skin tests should be performed at Screening if not done within 12 months prior to the Screening Visit \n\n Must be free of clinically significant disease that would interfere with study evaluations \n\n Women of childbearing potential need to use a medically accepted method of birth control prior to Screening and during the study, or provide documentation of surgical sterilization. Women who are not sexually active at enrollment must consent to the use of a medically accepted method of birth control if/when they become sexually active during study participation. \n\n Female subjects of childbearing potential must have a negative urine pregnancy test at the time of enrollment at the Baseline Visit. \n\n ", - "exclusion_criteria": ": \n\n Women who are pregnant, intend to become pregnant during the study, or are nursing \n\n Evidence of nasal polyps, deviated septum, or other intranasal anatomical obstruction(s) that would interfere with nasal airflow \n\n Acute or chronic sinusitis being treated with antibiotics and/or topical or oral nasal decongestants \n\n Acute respiratory infection within 2 weeks of the Screening Visit \n\n Diagnosis of clinically relevant sleep problems unassociated with allergies \n\n Complaints (within 12 months of the Screening Visit to their health-care provider) of difficulty sleeping or daytime sleepiness while not experiencing SAR symptoms, and continue with these complaints \n\n Snoring associated with an enlarged uvula or other upper airway pathology \n\n Had episodes of snoring associated with gasping or choking \n\n Awakened suddenly, on more than 1 occasion during the month preceding the Screening Visit, with a gasping or choking feeling \n\n Requires the use of oral appliances at night for bruxism (teeth gnashing) or temporomandibular joint problems \n\n Diagnosis of asthma with daytime and nighttime asthma symptoms not controlled by short-acting beta-2 adrenoceptor agonists \n\n Dependence on nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids. \n\n Currently undergoing a progressive course of immunotherapy (hyposensitization). Subjects on a regular maintenance schedule prior to the Screening Visit and who wish to remain on this schedule during the study are eligible for study inclusion; however, they may not receive hyposensitization treatment within 24 hours prior to any study visit \n\n Smokers or ex-smokers who have smoked within the previous 6 months \n\n Concomitant medical problem that may interfere with participation in the study, eg, repeated migraine episodes, uncontrolled convulsive disorders. \n\n Any of the following clinical conditions: Active or quiescent tuberculosis infection of the respiratory tract, untreated fungal, bacterial, systemic viral infections or ocular herpes simplex. \n\n Subjects participating in any other clinical study(ies). \n\n Subjects allergic to or with a sensitivity to the study drug or its excipients. \n\n Subjects who are night-shift workers or do not have a standard asleep at night/awake during the day cycle", - "brief_summary": "This study will hope to show that by relieving the participant's nasal symptoms of seasonal allergies using mometasone furoate nasal spray, the participant will obtain a better quality of night-time sleep, which in turn, causes less daytime sleepiness so that he/she can function productively during the day.", - "NCTID": "NCT00358527" - }, - { - "brief_title": "Melatonin for Sleep in Children With Autism", - "phase": "Phase 1", - "drugs": "['supplemental liquid melatonin', 'flavored liquid or liquid supplemental melatonin']", - "drugs_list": [ - "supplemental liquid melatonin", - "flavored liquid or liquid supplemental melatonin" - ], - "diseases": "['Autistic Disorder', 'Insomnia']", - "diseases_list": [ - "Autistic Disorder", - "Insomnia" - ], - "enrollment": "17.0", - "inclusion_criteria": "inclusion criteria: \n\n Children with autism ages 4-10 years. \n\n Diagnosis of autism based on Autism Diagnostic Observation Schedule (ADOS). \n\n Time to fall asleep of 30 minutes or longer by parent report at least 3 nights/week in the last 3 months. \n\n Children may take seasonal allergy medications. \n\n Children may take the following medications for the same dose at least 3 months: Citalopram (Celexa), Escitalopram (Lexapro), Amphetamine-dextroamphetamine (Adderall), Atomoxetine (Strattera), Methylphenidate(Ritalin), Dextroamphetamine(Dexedrine), Risperidone (Risperdal. \n\n ", - "exclusion_criteria": ": \n\n Children taking medications other than those in the inclusion criteria. \n\n Children with primary sleep disorder other than insomnia (such as sleep-disordered breathing). \n\n Children with non-febrile unprovoked epileptic seizure within the last two years. \n\n Children with liver disease or high fat diets, as melatonin metabolism may be affected in these children. \n\n Children who are visually impaired (partially or completely blind) as light suppresses melatonin synthesis and these children may have altered diurnal melatonin rhythms. \n\n Children with known genetic syndromes co-morbid with autism including fragile X, Down syndrome, neurofibromatosis, or tuberous sclerosis. \n\n Children who have outside normal limits on blood work for complete blood count, liver and renal function and hormone levels of ACTH, cortisol, LH, FSH, prolactin, testosterone and estradiol. \n\n Tanner staging beyond level 1 at any time point in the study. \n\n Children whose assessment score does not place them on the autism spectrum.", - "brief_summary": "The purpose of this study is to determine if liquid supplemental melatonin is an effective treatment for children with autism who have sleep problems related to insomnia (difficulty falling asleep).", - "NCTID": "NCT00927030" - }, - { - "brief_title": "Mirena and Estrogen for Control of Perimenopause Symptoms and Ovulation Suppression", - "phase": "", - "drugs": "['Mirena', 'Estradiol', 'Placebo Gel']", - "drugs_list": [ - "Mirena", - "Estradiol", - "Placebo Gel" - ], - "diseases": "['Menopausal and Other Perimenopausal Disorders']", - "diseases_list": [ - "Menopausal and Other Perimenopausal Disorders" - ], - "enrollment": "39.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 40-52 \n\n History of regular menstrual cycles every 20-35 days in mid-reproductive life (20-35 years of age) \n\n At least 1 period within the past 3 months \n\n BMI less than 35 kg/m2 \n\n Presence of at least one of the following perimenopausal symptoms: \n\n Hot flashes (vasomotor symptoms) \n\n Cyclical headache, bloating or adverse mood \n\n Self-reported poor quality of sleep \n\n ", - "exclusion_criteria": ": \n\n Age < 40 years \n\n Hysterectomy or bilateral oophorectomy \n\n Cigarette smoking \n\n Signs or symptoms of restless leg syndrome or sleep apnea \n\n Any chronic renal or hepatic disease that might interfere with excretion of gonadotropins or sex steroids \n\n Moderate/vigorous aerobic exercise > 4 hours per week \n\n Inability to read/write English \n\n Pregnant Women \n\n Prisoners \n\n Decisionally challenged subjects \n\n Any medical condition that makes use of Topical estradiol or Mirena contraindicated. \n\n Sex hormone use within the past 30 days \n\n History of cancer, blood clots or blood clotting disorder", - "brief_summary": "Hormonal treatment of perimenopausal women has frequently utilized oral contraceptive pills (OCPs). Because of their ability to suppress ovulation and establish cycle control, OCPs have become a popular option, and one that is FDA approved for use until menopause. However, use of OCPs in women in their 40's and 50's carries significant cardiovascular risks. Venous thromboembolism risk is 3-6 fold greater in OCP users, and the risk of myocardial infarction (MI) is approximately doubled in OCP users over the age of 40. This occurs at an age where the background population risk of MI begins to increase, such that the absolute number of cases rises substantially. Women with additional risk factors for cardiovascular disease have a much greater risk for MI (6-40-fold) in association with OCPs. There are also large subgroups of midlife women who are not candidates for OCP use, such a smokers and migraineurs. Moreover, the trend towards lower estrogen dosing with OCPs containing 20 micrograms of ethinyl estradiol has not led to a detectable decrease in thromboembolic risk.~Because of their increased potential risks, it is appropriate to seek alternatives to OCPs and to explore lower doses of hormones to relieve perimenopausal symptoms that occur prior to a woman's final menses. Recent evidence indicates that the hypothalamic-pituitary axis of reproductively aging women is more susceptible to suppression by sex steroids that previously believed. It is possible that hormone doses as low as 50 micrograms of transdermal estradiol (TDE) can suppress the hypothalamic-pituitary axis of midlife women. It is also tempting to speculate that the low but measurable circulating doses of levonorgestrel that are present when a woman uses the Mirena intrauterine system (IUS) can contribute to or even independently suppress the hypothalamic-pituitary axis, and reduce the hormonal fluctuations that result in worsening of perimenopausal symptoms. The combination of low dose TDE plus Mirena may therefore confer superior symptom control as well as contraceptive effectiveness, at far less risk.", - "NCTID": "NCT01613131" - } - ], - "1": [ - { - "brief_title": "Evaluating the Relationship Between Sleep-Disordered Breathing and Daytime Alertness", - "phase": "", - "drugs": "['Continuous Positive Airway Pressure (CPAP)']", - "drugs_list": [ - "Continuous Positive Airway Pressure (CPAP)" - ], - "diseases": "['Sleep Apnea, Obstructive']", - "diseases_list": [ - "Sleep Apnea", - "Obstructive" - ], - "enrollment": "144.0", - "inclusion_criteria": "inclusion criteria: \n\n Experiences symptoms of OSA, including snoring and sleepiness \n\n Stable medical history with no change in medications that could affect sleepiness \n\n ", - "exclusion_criteria": ": \n\n Suspected diagnosis of a sleep disorder other than OSA (i.e., periodic leg movements, narcolepsy, insomnia, central sleep apnea, sleep hypoventilation syndrome) \n\n Medically unstable health conditions (e.g., heart attack, congestive heart failure) \n\n Use of psychotropic medications that cause sedation in the 3 months prior to study entry \n\n Recent or confirmed history of recreational drug use or alcohol abuse \n\n Pregnant \n\n Inability to communicate verbally, write, or read \n\n Visual, hearing, or cognitive impairment", - "brief_summary": "Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person repeatedly stops breathing, or experiences shallow breathing for short periods of time during sleep. Daytime sleepiness is a common symptom of OSA and may affect an individual's level of alertness throughout the day. The primary purpose of this study is to evaluate the relationship between the severity of sleep-disordered breathing and levels of daytime alertness at baseline (untreated state) in a group of subjects with and without sleep apnea. In addition the change in daytime sleepiness in subjects with sleep apnea being treated with a continuous positive airway pressure (CPAP) machine, a common treatment for OSA will also be assessed.", - "NCTID": "NCT00393913" - }, - { - "brief_title": "Pediatric Adenotonsillectomy Trial for Snoring", - "phase": "", - "drugs": "['Early Adenotonsillectomy (eAT)', 'Watchful Waiting with Supportive Care (WWSC)']", - "drugs_list": [ - "Early Adenotonsillectomy (eAT)", - "Watchful Waiting with Supportive Care (WWSC)" - ], - "diseases": "['Sleep-Disordered Breathing']", - "diseases_list": [ - "Sleep-Disordered Breathing" - ], - "enrollment": "459.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of mild sleep-disordered breathing (MSDB) defined as meeting all of the following criteria: \n\n Caregiver report of habitual snoring that occurs most of the night on at least three nights per week, and has been present for at least three months (on average occurring > 3 nights per week or more half of sleep time) and \n\n Centrally-scored polysomnogram (PSG) confirming an obstructive apnea index (OAI) <1/hour and apnea-hypopnea index (AHI) \u22643/hour and no oxygen saturation (SpO2) desaturation < 90% in conjunction with obstructive events, confirmed on PSG. \n\n Tonsillar hypertrophy \u22652 based on a standardized scale of 0-4. \n\n Deemed to be a candidate for AT by otolaryngologist (ENT) evaluation (i.e., no technical issues that would be a contraindication for surgery such as submucous cleft palate.) \n\n Primary indication for AT is nocturnal obstructive symptoms (i.e., not recurrent infections or other indications). \n\n ", - "exclusion_criteria": ": \n\n Previous tonsillectomy, including partial tonsillectomy \n\n Recurrent tonsillitis that merits prompt adenotonsillectomy (AT) per the American Academy of Otolaryngology-Head and Neck Surgery Clinical Practice Guidelines (i.e., \u22657 episodes/yr in the past year; \u22655 episodes/year over the past 2 years or \u22653 episodes/yr over the past 3 years.) \n\n Severe obesity (body mass index (BMI) z-score \u22653). \n\n Failure to thrive, defined as either height or weight being below the 5th percentile for age and gender. \n\n Severe chronic health conditions that might hamper participation or confound key variables under study, including but not limited to: \n\n Severe cardiopulmonary disorders such as cystic fibrosis, and congenital heart disease. \n\n Bleeding disorders \n\n Sickle Cell Disease \n\n Epilepsy requiring medication \n\n Significant cardiac arrhythmia noted on PSG including: non-sustained ventricular tachycardia, atrial fibrillation, second degree atrioventricular block, sustained bradycardia, or sustained tachycardia. \n\n Other severe chronic health problems such as diabetes, narcolepsy, and poorly controlled asthma. \n\n Known genetic, craniofacial, neurological or psychiatric conditions likely to affect the airway, cognition or behavior; \n\n Current use of psychotropic medication (other than medications for attention deficit hyperactivity disorder, hypnotics, antihypertensives, hypoglycemic agents including insulin, anticonvulsants, anticoagulants, or growth hormone. \n\n Diagnosis of autism spectrum disorder. \n\n Intellectual deficit or assigned to a self-contained classroom for all academic subjects. \n\n History of severe developmental disability or Adaptive Behavior Assessment System (ABAS-3) score \u226460. \n\n Children/caregivers planning to move out of the area within the year. \n\n Children in foster care. \n\n Children/caregivers who do not speak English or Spanish well enough to complete the neurobehavioral measures.", - "brief_summary": "The purpose of this study is to evaluate the effects of early adenotonsillectomy (eAT) on the behavior, sleep-disordered breathing symptoms and quality of life for children who snore, but do not have obstructive sleep apnea, as well as identify factors that moderate responses to the surgery. Half of participants will receive eAT, while the other half will be observed with watchful waiting and supportive care.", - "NCTID": "NCT02562040" - }, - { - "brief_title": "Identification of Sleep-Disordered Breathing in Children", - "phase": "", - "drugs": "['Observational follow-up study of adenotonsillectomy']", - "drugs_list": [ - "Observational follow-up study of adenotonsillectomy" - ], - "diseases": "['Sleep', 'Sleep Apnea Syndromes', 'Sleep Disordered Breathing']", - "diseases_list": [ - "Sleep", - "Sleep Apnea Syndromes", - "Sleep Disordered Breathing" - ], - "enrollment": "160.0", - "inclusion_criteria": "inclusion criteria: \n\n Assent of child (if over the age of 9 or younger but able to understand the nature of the study) \n\n At least one parent or guardian must sign an informed consent \n\n Child must be either a healthy volunteer or scheduled for an adenotonsillectomy for any reason \n\n Children scheduled for adenotonsillectomies must be referred to the program by a treating otolaryngologist who practices at the University of Michigan or St. Joseph Mercy Hospital in Ann Arbor, Michigan \n\n ", - "exclusion_criteria": ": \n\n Mental or physical limitations that would prevent proper interpretation of neurobehavioral tests \n\n Medical history that could confound interpretation of EEG or behavioral data, including epilepsy, psychiatric diagnoses (other than disruptive behavior disorders), head trauma with loss of consciousness for more than 30 seconds, or chronic medication use (e.g., benzodiazepines, other hypnotics, or antihistamines) \n\n Current treatment by a physician or past surgical treatment for SDB \n\n A known medical condition that carries independent high risk of SDB (e.g., Pierre Robin syndrome, Down syndrome, or neuromuscular disorders) or excessive daytime sleepiness (e.g., narcolepsy) \n\n Inability to schedule polysomnography, a Multiple Sleep Latency Test, and neurobehavioral testing before the surgical date \n\n Determination by any of the patient's physicians that sleep testing is required before surgery can be scheduled (to avoid the possibility that study enrollment itself could affect ability to complete the study) \n\n Prior enrollment of a sibling in the study \n\n Expectation that the child will no longer have convenient access to University of Michigan facilities within 6 months or expectation of further surgery within that period \n\n Additional ", - "brief_summary": "The purpose of this research is to study and improve the methods used to detect childhood breathing problems during sleep that can affect daytime behavior at home and school. Early diagnosis of these sleep disorders may allow doctors to treat children at a time when the consequences can still be reversed.", - "NCTID": "NCT00233194" - }, - { - "brief_title": "Evaluation of Swallowing in Patients With Obstructive Sleep Apnea", - "phase": "", - "drugs": "['clinical, endoscopical and manometric evaluation']", - "drugs_list": [ - "clinical", - "endoscopical and manometric evaluation" - ], - "diseases": "['Sleep Apnea, Obstructive']", - "diseases_list": [ - "Sleep Apnea", - "Obstructive" - ], - "enrollment": "21.0", - "inclusion_criteria": "inclusion criteria: \n\n diagnosis of obstructive sleep apnea syndrome \n\n ", - "exclusion_criteria": ": \n\n other causes of dysphagia \n\n pharyngeal surgery \n\n prior treatment for obstructive sleep apnea", - "brief_summary": "The purpose of this study is to test the hypothesis that obstructive sleep apnea syndrome is associated with deviant pharyngeal swallowing function, using clinical, endoscopical and manometric evaluation.", - "NCTID": "NCT01335594" - }, - { - "brief_title": "Follow-up Studies of Primary Snoring(PS) and Obstructive Sleep Apnea Hypopnea Syndrome(OSAHS) in Chinese Children", - "phase": "", - "drugs": "['Adenotonsillectomy', 'Conservative treatment', 'no treatment']", - "drugs_list": [ - "Adenotonsillectomy", - "Conservative treatment", - "no treatment" - ], - "diseases": "['Obstructive Sleep Apnea Syndrome']", - "diseases_list": [ - "Obstructive Sleep Apnea Syndrome" - ], - "enrollment": "500.0", - "inclusion_criteria": "inclusion criteria: \n\n Children aged 3-12 yrs, who are referred for clinical evaluation of habitual snoring and who were scheduled for an overnight polysomnogram. \n\n ", - "exclusion_criteria": ": \n\n Children who are suffered from any chronic medical or psychiatric condition \n\n Children with acute respiratory infection \n\n Children with severe craniofacial deformities \n\n Children with cardiopulmonary diseases \n\n Children with a genetic syndrome that was known to affect cognitive abilities, or are receiving medications that are known to interfere with memory or sleep onset or heat rate", - "brief_summary": "The study is designed to investigate the natural course of Primary snoring in 1-2 years or more and the different effect of drug and surgical treatment applied in children with obstructive sleep apnea (OSAS) by comparing the polysomnography(PSG) and sleep questionaires in 6 months after treatment.", - "NCTID": "NCT02447614" - }, - { - "brief_title": "Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children", - "phase": "", - "drugs": "['CPAP treatment', 'No CPAP treatment']", - "drugs_list": [ - "CPAP treatment", - "No CPAP treatment" - ], - "diseases": "['Sleep Apnea, Obstructive', 'Sleep Apnea Syndromes', 'Child Behavior Disorders', 'Attention Deficit Disorder With Hyperactivity', 'Disorders of Excessive Somnolence']", - "diseases_list": [ - "Sleep Apnea", - "Obstructive", - "Sleep Apnea Syndromes", - "Child Behavior Disorders", - "Attention Deficit Disorder With Hyperactivity", - "Disorders of Excessive Somnolence" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Children ages 5-12 years old, \n\n Scheduled for an adenotonsillectomy for treatment of sleep apnea, \n\n Child must provide assent, and \n\n Parent or legal guardian must be able to speak and read English, and agree to the study. \n\n ", - "exclusion_criteria": ": \n\n No siblings of children already enrolled in the study, \n\n Children who expect to have another surgery (in addition to AT) during the period of participation in this study, \n\n Neurological, psychiatric, or medical conditions, or social factors that may affect test results, prevent children from returning for required study visits, or interfere with the study treatment, or \n\n Certain medications that affect sleepiness or alertness, for example: \n\n Stimulants (such as Ritalin, Adderall, or Concerta), \n\n Sleep aides (such as Melatonin, Ambien, or Ativan), or \n\n Sedating medicines (such as Benadryl, Klonopin, Xanax, or Valerian).", - "brief_summary": "Obstructive sleep-disordered breathing (SDB) affects 2-3% of children and may lead to problems with nighttime sleep and daytime behavior, learning, sleepiness, and mood. Adenotonsillectomy (AT) is the second most common surgical procedure in children. It is now performed more often for suspected SDB than for any other indication. However, recent studies indicate that many if not most children still have SDB after AT, and many still have learning or behavioral problems associated with SDB. The goals of this study are: (1) to assess the extent that behavior, cognition, and sleepiness in children can improve with Continuous positive airway pressure (CPAP) treatment after AT, and (2) to identify which patients stand to gain most from post-operative assessment and treatment.", - "NCTID": "NCT01554527" - }, - { - "brief_title": "Investigating Reaction Time Among Children Who Snore", - "phase": "", - "drugs": "['PVT-192']", - "drugs_list": [ - "PVT-192" - ], - "diseases": "['Snoring']", - "diseases_list": [ - "Snoring" - ], - "enrollment": "93.0", - "inclusion_criteria": "inclusion criteria: \n\n Ability to understand how to perform reaction time test and complete without assistance. \n\n ", - "exclusion_criteria": ": \n\n Children who are unable to understand or perform test or parents refusal.", - "brief_summary": "The investigators feel that children who have OSA or sleep-disordered breathing may have a different reaction time than normal variants. Children who have OSA are known to have behavioral and sleep patterns that are different. It makes sense their reaction time may be different than normal as well. We plan to measure reaction times via a 10 minute psychomotor vigilance test device in children who snore who are coming in for a sleep study or for adenotonsillectomy.", - "NCTID": "NCT02053012" - }, - { - "brief_title": "Evaluating Behavioral Treatments to Improve Adherence to Continuous Positive Airway Pressure (CPAP) Therapy in People With Obstructive Sleep Apnea (The BREATHE Study)", - "phase": "", - "drugs": "['MET', 'ED']", - "drugs_list": [ - "MET", - "ED" - ], - "diseases": "['Sleep Apnea, Obstructive', 'Continuous Positive Airway Pressure']", - "diseases_list": [ - "Sleep Apnea", - "Obstructive", - "Continuous Positive Airway Pressure" - ], - "enrollment": "306.0", - "inclusion_criteria": "inclusion criteria: \n\n OSA confirmed by polysomnography (PSG) \n\n CPAP is the prescribed form of treatment for OSA \n\n Judged by sleep physician to respond to CPAP \n\n ", - "exclusion_criteria": ": \n\n Apnea/hypoxia index (AHI) less than 15 and no daytime functional symptoms or associated cardiovascular disease \n\n Diagnosis of another sleep disorder that causes arousals from sleep \n\n Past treatment for OSA \n\n Current substance abuse problem \n\n Diagnosis of a serious medical condition that would interfere with involvement in the study \n\n History of a major psychiatric disorder, other than depression \n\n Change in antidepressant medication in the 3 months before study entry", - "brief_summary": "Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person repeatedly stops breathing or experiences shallow breathing for short periods of time during sleep. The most common treatment for OSA is the use of a continuous positive airway pressure (CPAP) machine, but many people have trouble adhering to the treatment schedule. This study will evaluate the effectiveness of two behavioral therapy programs used in combination with CPAP for improving treatment adherence in people with OSA.", - "NCTID": "NCT00623246" - }, - { - "brief_title": "Single Dose Pharmacokinetic and Pharmacodynamic Evaluation of Three Different Doses of Zolpidem in Children", - "phase": "Phase 1; Phase 2", - "drugs": "['Zolpidem']", - "drugs_list": [ - "Zolpidem" - ], - "diseases": "['Insomnia', 'Sleep Disorder']", - "diseases_list": [ - "Insomnia", - "Sleep Disorder" - ], - "enrollment": "63.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female between the ages of 2 years and 18 years. \n\n Written consent must be obtained form the parent/legal guardian for all minors. Written assent must be obtained from all minors > 6 years of age. \n\n Female subjects of child-bearing potential must not be pregnant and if females are fertile and sexually active, must have documented a negative urine HCG and assure use of effective contraception acceptable to the investigator (abstinence accepted) during the study period. \n\n Subjects must meet the following criteria for a diagnosis of insomnia as determined by the subject's private physician or study investigator and subject's history: \n\n the complaint is significant difficulty (defined by frequency, severity, and/or chronicity) initiating or maintaining sleep;. The problem is viewed problematic by the child and/or caregiver; \n\n the sleep disturbance causes clinically significant impairment in school performance, behavior, learning, or development for the child as reported by the child and/or caregiver; \n\n the sleep disturbance does not occur exclusively in the context of an intrinsic dyssomnia such as narcolepsy, restless legs syndrome, or sleep-related breathing disorders; a circadian rhythm disorder; or a parasomnia; \n\n the sleep disturbance is not attributable to either the direct physiologic effect of a drug of abuse or misuse of a prescribed medication. \n\n ", - "exclusion_criteria": ": \n\n Pregnancy and/or breastfeeding; \n\n The presence of any untreated (where treatment is available), or unstable, progressive, or evolving clinically significant renal, endocrine, hepatic, respiratory, cardiovascular, neurologic, hematologic, immunologic, cerebrovascular disease or malignancy; \n\n Elevations in screening blood tests of renal (SCr) and liver (ALT, AST and/or bilirubin) > 2 times the upper limit of normal for age. \n\n Receiving any medications that may modulate Zolpidem metabolism, primarily drugs that will enhance or reduce the activity of CYP450 3A, 2C9, or 2D6 activity. Note: If patient is receiving a medication that might be considered an inducer or an inhibitor, please discuss with the PI prior to excluding them. \n\n Receiving any medications with sleep-impairing properties at a dose/dose interval that would be judged by the study investigator as to interfere with the assessment of Zolpidem sleep response. \n\n Currently using any systemic contraceptive steroids including: oral contraceptives, transdermal patch, vaginal insert, levonorgestrel implant and medroxyprogesterone acetate contraceptive injection.", - "brief_summary": "This is a multicenter trial to evaluate the single-dose safety, tolerability and pharmacokinetics-pharmacodynamics of Zolpidem in a group of children with sleep disturbances stratified by age and dose.", - "NCTID": "NCT00494468" - } - ], - "2": [] - }, - { - "patient_id": "sigir-20159", - "patient": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", - "0": [ - { - "brief_title": "The Interaction Between Severe Acute Respiratory Distress Syndrome Viral Proteins and Monocytes", - "phase": "", - "drugs": "['blood sampling']", - "drugs_list": [ - "blood sampling" - ], - "diseases": "['Severe Acute Respiratory Syndrome']", - "diseases_list": [ - "Severe Acute Respiratory Syndrome" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy adults, children and cord blood", - "exclusion_criteria": "", - "brief_summary": "Severe acute respiratory syndrome (SARS) is a new threat to public health since November, 2002. The SARS is highly contagious and is believed to be transmitted by person-to-person through droplet and direct contact. The patients present with fever, chills, cough, myalgia, dyspnea, and diarrhea. The symptoms aggravate in the second week and nearly 40% of the patients develop respiratory failure that requires assisted ventilation. The mortality rate is reported as 6.5%-7%.~After several months, the world scientists found the etiology to be a new coronavirus not belonging to the previous coronavirus group I, II and III. The new virus is called SARS associated coronavirus (SARS-CoV).~Although the high morbidity and mortality of SARS occurred in adults, there was rare mortality reported in the children. The report from Hong Kong pointed out that the symptoms of SARS in younger children were milder and the clinical course was not as aggressive as in adults. Therefore, the aim of the project is to design the experiment to see the differences of immunological responses to SARS-CoV protein in healthy younger children, teenagers, and adults. The investigators hope that the result could explain the reason for milder disease in younger children and the immunological pathogenesis of SARS.", - "NCTID": "NCT00172263" - }, - { - "brief_title": "Collection and Testing of Respiratory Samples", - "phase": "", - "drugs": "['artus Influenza A/B RT-PCR Test']", - "drugs_list": [ - "artus Influenza A/B RT-PCR Test" - ], - "diseases": "['QIAGEN ResPlex II Advanced Panel', 'Influenza A', 'Respiratory Syncytial Virus Infections', 'Infection Due to Human Parainfluenza Virus 1', 'Parainfluenza Type 2', 'Parainfluenza Type 3', 'Parainfluenza Type 4', 'Human Metapneumovirus A/B', 'Rhinovirus', 'Coxsackie Virus/Echovirus', 'Adenovirus Types B/C/E', 'Coronavirus Subtypes 229E', 'Coronavirus Subtype NL63', 'Coronavirus Subtype OC43', 'Coronavirus Subtype HKU1', 'Human Bocavirus', 'Artus Influenza A/B RT-PCR Test', 'Influenza B']", - "diseases_list": [ - "QIAGEN ResPlex II Advanced Panel", - "Influenza A", - "Respiratory Syncytial Virus Infections", - "Infection Due to Human Parainfluenza Virus 1", - "Parainfluenza Type 2", - "Parainfluenza Type 3", - "Parainfluenza Type 4", - "Human Metapneumovirus A/B", - "Rhinovirus", - "Coxsackie Virus/Echovirus", - "Adenovirus Types B/C/E", - "Coronavirus Subtypes 229E", - "Coronavirus Subtype NL63", - "Coronavirus Subtype OC43", - "Coronavirus Subtype HKU1", - "Human Bocavirus", - "Artus Influenza A/B RT-PCR Test", - "Influenza B" - ], - "enrollment": "272.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects that sign the Informed Consent form required for prospectively enrolling patients into the study. \n\n Subjects that present at a hospital, clinic, or physician's office with the signs and symptoms of a respiratory tract infection. \n\n Subjects with an acute respiratory infection where said acute respiratory infection is suspected of being caused by an Influenza virus. \n\n ", - "exclusion_criteria": ": \n\n Subjects where the duration of the symptoms of such an acute respiratory infection is greater than or equal to 5 days (i.e., \u22655).", - "brief_summary": "The study will be conducted using nasopharyngeal swab specimens collected prospectively from individuals suspected of having the signs and symptoms of an acute respiratory tract infection caused by a respiratory virus. A series of standard viral culture tests validated for routine use in the clinical laboratory, and/or a series of PCR-based Laboratory Developed Tests (PCR-LDT) validated by a central reference laboratory will be used to verify the performance of the investigational artus Influenza A/B RT-PCR test and the QIAGEN ResPlex II Advanced Panel test. From each specimen five (5) aliquots will be prepared: (a) one aliquot will be tested in real-time using the assigned viral culture reference methods; (b) one aliquot will be used to extract nucleic acid in real-time for investigational testing; (c) one aliquot of the specimen will be stored at --70C for subsequent shipment to the reference laboratory for PCR-LDT testing, (d) one aliquot will be archived at -70C for subsequent follow-up by the reference laboratory (e.g., bi-directional sequencing of positive specimens), and (e) any remaining specimen will be stored for the Fresh vs. Frozen Study. The extracted nucleic acid generated from the second aliquot (i.e., b above) will be split and subjected to testing by both the artus Influenza A/B RT-PCR test and the ResPlex II Advanced Panel test.", - "NCTID": "NCT01302418" - }, - { - "brief_title": "The Benefit and Harm of Fever Suppression by Antipyretics in Influenza", - "phase": "Phase 4", - "drugs": "['Paracetamol', 'Placebo', 'Backup NSAID ibuprofen']", - "drugs_list": [ - "Paracetamol", - "Placebo", - "Backup NSAID ibuprofen" - ], - "diseases": "['Influenza']", - "diseases_list": [ - "Influenza" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults aged between 18-30 \n\n Presenting with symptoms of acute URTI (at least two among the following symptoms: body temperature \u226537.8\u00b0C, cough, rhinorrhea, sore throat, headache, myalgia/arthralgia) within 48 hours of illness onset \n\n being tested positive with a QuickVue rapid influenza test \n\n ", - "exclusion_criteria": ": \n\n Allergic to paracetamol or any other antipyretics \n\n Have any underlying immunocompromized condition or be receiving immunosuppressive agents. \n\n Have any history of chronic liver disease, or any active lung, heart or renal diseases requiring regular medication.", - "brief_summary": "The purpose of this study is to investigate the potential benefits and risks of antipyretics use in naturally occurring influenza virus infections in humans.", - "NCTID": "NCT01891084" - }, - { - "brief_title": "Acute Viral Hepatitis and Diabetes Mellitus", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Acute Viral Hepatitis', 'Diabetes Mellitus']", - "diseases_list": [ - "Acute Viral Hepatitis", - "Diabetes Mellitus" - ], - "enrollment": "250.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients between the ages of 18 to 70 years \n\n ", - "exclusion_criteria": ": \n\n Recent intake of drugs known to cause acute hepatitis \n\n History of alcohol ingestion >40mg/day \n\n Suspected ischemic hepatitis \n\n Illness causing acute hepatitis such as Malaria hepatits, enteric hepatitis, Leptospirosis, septecemia \n\n HIV. \n\n Associated co morbidities, which can affect survival such as cardiovascular disease and diabetic nephropathy. \n\n Recent intake of drugs known to cause acute hepatitis \n\n History of alcohol ingestion >40mg/day \n\n Suspected ischemic hepatitis \n\n Malaria hepatits, enteric hepatitis, Leptospirosis, septecemia \n\n Co infection with HIV. \n\n Comorbidities which affect survival such as CAD and diabetic nephropathy. \n\n Gestational diabetes \n\n Pregnant female \n\n Cirrhosis", - "brief_summary": "It has been observed that several of patients having prolonged or complicated course of acute viral hepatitis have underlying diabetes. It is possible that with impaired hepatocyte regenerating capacity, these patients run a more prolonged and complicated course.~We hypothesize that acute hepatitis infection has a prolonged and complicated course among diabetic patients.", - "NCTID": "NCT00689546" - }, - { - "brief_title": "Household Transmission of Zoonotic Influenza Viruses in a Cohort of Egyptian Poultry Growers", - "phase": "", - "drugs": "['Questionnaire', 'Blood sample', 'Nasal wash', 'Throat swab']", - "drugs_list": [ - "Questionnaire", - "Blood sample", - "Nasal wash", - "Throat swab" - ], - "diseases": "['Influenza']", - "diseases_list": [ - "Influenza" - ], - "enrollment": "2400.0", - "inclusion_criteria": "inclusion criteria: \n\n Poultry-exposed individuals with poultry in the household willing to participate by signing a consent or assent form as appropriate for age, completing the study questionnaire, and permitting the withdrawal of blood, nasal washes, nasal swabs, and throat swabs. \n\n ", - "exclusion_criteria": ": \n\n Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy. (Note that we have chosen to exclude such populations because of their increased risk of acquiring infections, they are relatively few, and are not representative of a national sample.) \n\n Terminally ill individuals. \n\n Children who are less than 2 years old when baseline enrollment is performed.", - "brief_summary": "This study seeks to determine the incidence and transmission of avian influenza viruses in humans exposed to poultry. Enrolled subjects will be selected from five different rural areas (villages) in the Nile delta region in Egypt where poultry are commonly raised. From those study sites, 2400 healthy subjects will be monitored for 6 years with annual follow up visits to measure sero-prevalence and exposure variables, and more importantly, biweekly or weekly visits to measure incidence of infection, measure secondary transmission rates, monitor symptoms, and assess immunological response.~Primary Objectives:~To estimate the incidence of avian influenza (AI) in poultry-exposed human populations.~To estimate sero-prevalent of AI in poultry-exposed human populations.~To investigate potential risk factors associated with AI human infections in poultry-exposed individuals.~To investigate secondary infection risk for household contacts.~Secondary Objectives:~To characterize the antigenic and genetic makeup of AI viruses infecting humans.~To monitor the pathogenicity and disease severity of AI viruses causing human infections and the associated immune response.~To investigate the serologic response following confirmed influenza virus infection.", - "NCTID": "NCT02459171" - }, - { - "brief_title": "Clinical Evaluation of QFlu Combo Test", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cough', 'Myalgia', 'Nasal Obstruction', 'Sore Throat', 'Headache', 'Fatigue', 'Fever']", - "diseases_list": [ - "Cough", - "Myalgia", - "Nasal Obstruction", - "Sore Throat", - "Headache", - "Fatigue", - "Fever" - ], - "enrollment": "506.0", - "inclusion_criteria": "inclusion criteria: \n\n Those who exhibit flu-like symptom(s) during a flu season and who (or whose guardians) are willing to participate in the study.", - "exclusion_criteria": "", - "brief_summary": "Currently effective antivials for influenza treatment are two influenza viral neuraminidase inhibitors, oseltamivir (Tamiflu) and zanamivir (Relenza). Resistance to these drugs is reflected by reduced susceptibility of viral neuraminidase to these drugs. The hypothesis is that the signal ratio of two reagents (with or without a single concentration of the drug) correlates the IC50 value, an accurate measurement of drug resistance but impractical for clinical use.", - "NCTID": "NCT01506583" - }, - { - "brief_title": "Clinical IGSP-CHOP Boston", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Influenza']", - "diseases_list": [ - "Influenza" - ], - "enrollment": "500.0", - "inclusion_criteria": "inclusion criteria: \n\n For pediatric population: Age of patient: 30 days - 5 years; for adult population: any age \n\n Illness onset within past 5 days \n\n Symptoms of fever (>=38\u00b0) plus one or more of the following: cough, runny nose, congestion, or sneezing (twice or more within one day). These symptoms must be present at the time of presentation to the emergency department (ED) or admission to the hospital. \n\n Patient or parent/guardian is able to give informed consent \n\n ", - "exclusion_criteria": ": \n\n Pediatric patient or non-verbal adult is not accompanied by a caregiver \n\n Participant/caregiver cannot be reached by phone in 7-10 days \n\n Patient has a condition that can compromise respiratory function or the handling of respiratory secretions (e.g., severe cognitive dysfunction, spinal cord injuries, or other neuromuscular disorders)", - "brief_summary": "The main purpose of this study is to look at relationships between types of flu viruses and characteristics of infected patients, including vaccination status, organ system involvement, and disease severity. In this study, 500 patients with respiratory illnesses will have nose/throat fluid samples collected. At Children's Hospital Boston, patients 30 days to 5 years of age will be recruited; at Beth Israel Deaconess Medical Center, patients of any age will be eligible. The researchers will compare the symptoms of infection by similar flu virus types and look at differences in the flu virus types between the 2 age groups of patients. The researchers will also look at whether any flu virus types first show up in the children prior to infecting the adults. Hopefully this study will improve understanding of how flu viruses develop, spread, and cause disease. This information may help the development of more effective flu vaccines, prevention measures, and treatments.", - "NCTID": "NCT00428831" - }, - { - "brief_title": "Phase I Study of West Nile Virus Vaccine", - "phase": "Phase 1", - "drugs": "['VRC-WNVDNA020-00-VP']", - "drugs_list": [ - "VRC-WNVDNA020-00-VP" - ], - "diseases": "['West Nile Fever']", - "diseases_list": [ - "West Nile Fever" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n A participant must meet all of the following criteria: \n\n 18 to 65 years old. \n\n Available for clinical follow-up through Week 32 and contact (correspondence, telephone or e-mail) or clinical visit through Week 52 of the study. \n\n Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. \n\n Complete an Assessment of Understanding prior to enrollment and verbalize understanding of all questions answered incorrectly. \n\n Able and willing to complete the informed consent process. \n\n Willing to receive HIV test results and willing to abide by NIH guidelines for partner notification of positive HIV results. \n\n Willing to donate blood for sample storage to be used for future research and genetic testing, including HLA analysis. \n\n In good general health without clinically significant medical history and has satisfactorily completed screening. \n\n Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) less than 40 within the 28 days prior to enrollment. \n\n Laboratory Criteria within 28 days prior to enrollment: \n\n Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to 13.5 g/dL for men. \n\n White blood cell (WBC) equal to 3,300-12,000 cells/mm(3). \n\n Absolute neutrophil count (ANC) within institutional normal range. \n\n Total lymphocyte count greater than or equal to 800 cells/mm(3). \n\n Platelets equal to 125,000 - 400,000/mm(3). \n\n Alanine aminotransferase (ALT; SGPT) less than or equal to 1.25 x upper limit of normal. \n\n Serum creatinine less than or equal to 1 x upper limit of normal (less than or equal to 1.3 mg/dL for females; less than or equal to 1.4 mg/dL for males). \n\n Normal urinalysis defined as negative glucose, negative or trace protein, and no clinically significant blood in the urine. \n\n Negative FDA-approved HIV blood test. [Note: Results of HIV ELISA will be documented, but a negative HIV PCR will be sufficient for eligibility screening of subjects with positive HIV ELISA that is due to prior participation in an HIV vaccine study.] \n\n Negative hepatitis B surface antigen. \n\n Negative anti-HCV and negative hepatitis C virus (HCV) PCR. \n\n Laboratory Criteria within 12 weeks (84 days) prior to enrollment: \n\n Negative flavivirus serology (in the Focus Technologies WNV antibody ELISA assay) within 84 days prior to enrollment and no history of prior vaccination against yellow fever or Japanese encephalitis virus; and no history of prior vaccination against West Nile virus with an investigational vaccine. \n\n Female-Specific Criteria: \n\n Negative beta-HCG pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential. \n\n A female participant must meet any of the following criteria: \n\n No reproductive potential because of menopause (one year without menses) or because of a hysterectomy, bilateral oophorectomy, or tubal ligation, \n\n or \n\n Participant agrees to be heterosexually inactive at least 21 days prior to enrollment and through Week 32 of the study, \n\n or \n\n Participant agrees to consistently practice contraception at least 21 days prior to enrollment and through Week 32 of the study by one of the following methods: \n\n condoms, male or female, with or without a spermicide \n\n diaphragm or cervical cap with spermicide \n\n intrauterine device \n\n contraceptive pills or patch, Norplant, Depo-Provera or other FDA-approved contraceptive method \n\n male partner has previously undergone a vasectomy \n\n ", - "exclusion_criteria": ": \n\n A volunteer will be excluded if one or more of the following conditions apply. \n\n Women: \n\n Breast-feeding or planning to become pregnant during the 32 weeks of study participation. \n\n Volunteer has received any of the following substances: \n\n Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past six months. (Note that use of corticosteroid nasal spray for allergic rhinitis, topical corticosteroids for an acute uncomplicated dermatitis, or short-acting beta-agonists in controlled asthmatics are not excluded). \n\n Blood products within 120 days prior to HIV screening. \n\n Immunoglobulin within 60 days prior to HIV screening. \n\n Investigational research agents within 30 days prior to initial study vaccine administration. \n\n Live attenuated vaccines within 30 days prior to initial study vaccine administration. \n\n Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration. \n\n Current anti-TB prophylaxis or therapy. \n\n Volunteer has a history of any of the following clinically significant conditions: \n\n Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain. \n\n Autoimmune disease or immunodeficiency. \n\n Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids. \n\n Diabetes mellitus (type I or II), with the exception of gestational diabetes. \n\n History of thyroidectomy or thyroid disease that required medication within the past 12 months. \n\n Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years. \n\n Hypertension that is not well controlled by medication or is more than 145/95 at enrollment. \n\n Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws. \n\n Malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of the study. \n\n Seizure disorder other than: 1) febrile seizures under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring treatment within the last 3 years. \n\n Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen. \n\n Allergic reaction to aminoglycoside antibiotics. \n\n Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within five years prior to enrollment, a history of suicide plan or attempt. \n\n Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent. \n\n Active smoker within the past 5 years AND with 25 pack-years or greater smoking history. \n\n If age 51-65 years and with 3 or more of the 5 health risk factors noted below, the subject will be excluded: \n\n Current smoker (or quit smoking less than 28 days prior to enrollment) \n\n BMI greater than 35 \n\n Fasting low density lipoprotein (LDL) greater than 159 mg/dL or fasting cholesterol greater than 239 mg/dL \n\n Systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg \n\n Fasting blood glucose greater than 125 mg/dL \n\n Note: The fasting blood tests require 8 hours fast prior to the blood draw. The results used for eligibility screening must be from tests completed no more than 12 weeks (84 days) prior to day of enrollment. The individual criteria for BMI (inclusion item 9), blood pressure (exclusion item 15) and smoking history (exclusion item 23) must also be met.", - "brief_summary": "This study will test the safety of an experimental vaccine for preventing West Nile virus infection. The virus is spread mainly by mosquito bites. Symptoms can include high fever, headache, neck stiffness, stupor, muscle weakness, vision loss, numbness and paralysis. Rarely, infection leads to permanent nerve damage and possibly death. The vaccine used in the study is made from DNA that codes for West Nile virus proteins. Injected into a muscle, the DNA instructs the body to make a small amount of West Nile virus protein. This study will see if the body creates resistance or immunity to these proteins. Participants cannot get West Nile virus from the vaccine.~Healthy normal volunteers between 18 and 65 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests for various infections and other medical problems. Women who are able to become pregnant are given a pregnancy test. Women who are pregnant or breastfeeding may not participate. Anyone who has received a vaccination for Yellow Fever or Japanese Encephalitis virus in the past may not participate in this research study.~Participants will receive three injections of the experimental vaccine, the first on the first study day (Day 0), the second on Day 28, and the third on Day 56. The injections are given with a device called Biojector\u00ae (Registered Trademark) 2000 that delivers the vaccine through the skin into the muscle without the use of a needle. On the day of each injection, subjects are given a diary card to take home for recording their temperature and any symptoms or side effects for 5 days. They return to the clinic 2 weeks after each injection, bringing the completed card with them at that time. In addition to the injections, subjects have the following tests and procedures during clinic visits:~Medical history and, if needed, physical examination: Day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32~Vital signs and weight: Day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32~Lymph node exam: Day 0 and weeks 2, 4, 6, 8, 10, and 12~Blood samples: Day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32~Pregnancy test (for women): Day 0 and weeks 4, 8 and 32~Urine sample: Day 0 and weeks 2, 4, 6, 8, and 10~The blood and urine tests are for health checks. Some blood samples are also used to study the immune response to the vaccine and for gene testing.", - "NCTID": "NCT00300417" - }, - { - "brief_title": "Host Responses in Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection", - "phase": "", - "drugs": "['blood samples', 'blood samples']", - "drugs_list": [ - "blood samples", - "blood samples" - ], - "diseases": "['Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection']", - "diseases_list": [ - "Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection" - ], - "enrollment": "17.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 18 years \n\n Transplanted by a functional kidney \n\n affected by a hepatitis E chronic \n\n Benefiting from a follow-up in the Center of Nephrology and renal Transplantation or in the service of H\u00e9pato-gastro-ent\u00e9rologie of the CHU The Conception in Marseille \n\n Having signed a consent informed about participation in the study \n\n ", - "exclusion_criteria": ": \n\n Affected by another sharp or chronic viral infection", - "brief_summary": "Hepatitis E is a worldwide disease. It is the leading or second leading cause of acute hepatitis in adults in developing countries from sub-Saharan Africa or Southeast Asia, where it is hyperendemic and principally water-borne. In industrialised western countries, hepatitis E was until recently considered as imported from hyperendemic geographical areas, but is currently an emerging autochthonous infectious disease. A growing body of data from Europe, America, Australia, and Asia strongly indicate that pigs represent a major Hepatitis E Virus (HEV) reservoir and might be a source of zoonotic transmission to humans through direct or indirect exposure. Hepatitis E typically causes self-limited acute infection. However, the overall death rate is 1-4%, and it can reach 20% in pregnant women and might be still higher in patients with underlying chronic liver disease. To date, no preventive or curative treatment of hepatitis E is available.", - "NCTID": "NCT01090232" - }, - { - "brief_title": "Trial on the Ideal Duration of Oral Antibiotics in Children With Pneumonia", - "phase": "Phase 4", - "drugs": "['Amoxicillin-Potassium Clavulanate Combination', 'Placebo']", - "drugs_list": [ - "Amoxicillin-Potassium Clavulanate Combination", - "Placebo" - ], - "diseases": "['Pneumonia']", - "diseases_list": [ - "Pneumonia" - ], - "enrollment": "19.0", - "inclusion_criteria": "inclusion criteria: \n\n Children admitted with severe pneumonia as defined by the presence of all the following as defined as below: \n\n 3 months to 59 months old \n\n History of cough and/or shortness of breath \n\n Unwell for <= 7 days -Increased respiratory rate ( \u2265 50/min if \u226412 months old, \u2265 40/min) or retractions,- \n\n Any of the following signs/symptoms are present at examination that would necessitate admission: chest retractions, cyanosis, saturation< 92% on air, poor feeding or lethargy \n\n Documented fever (axillary /central temp \u2265 38/38.5\u00b0C) within 24 hrs of admission \n\n Abnormal CXR with presence of alveolar infiltrates \n\n Responds to IV antibiotics by the first 72 hrs and able to go home with oral antibiotics i.e. no more hypoxia and afebrile and reduced respiratory symptoms \n\n ", - "exclusion_criteria": ": \n\n Children who (a) are transferred from another hospital (b) refuse blood taking (c) have a doctor diagnosis of asthma or recurrent wheezing illness (d) have a diagnosis of bronchiolitis i.e. wheezing in a child with a CXR with no consolidation (e) not acute illness ( ie >7 days) (f) unable to come for follow-up (g) not community acquired pneumonia e.g. aspiration pneumonia (h)complicated pneumonia with effusion, pneumothorax, clinical suspicion of necrotizing pneumonia (i)PICU admission or use of Non-invasive ventilation (j)significant comorbidities that can increase the risk of having a complicated pneumonia- (k) need for use of other antibiotics like anti-staph or macrolides (l)extra-pulmonary infection e.g. meningitis (m)allergy to penicillin (n) unable to tolerate oral antibiotics (o) underlying illness that can predispose to recurrent pneumonia \n\n -", - "brief_summary": "To determine, in children hospitalized with pneumonia, if an extended duration of oral antibiotics (10 days) will be superior to a shorter duration (3 days) of antibiotics in improving clinical outcomes.~Secondary Aims:~Describe the prevalence of respiratory viruses and bacteria at presentation.~Investigate the depression, anxiety and stress scores (DASS21) and quality of life scored (QOL) by parents of the children during admission, pre-discharge and post discharge and at follow-ups.", - "NCTID": "NCT02258763" - }, - { - "brief_title": "Magnetic Resonance (MR) Spectroscopy In Familial Mediterranean Fever (FMF) Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Familial Mediterranean Fever']", - "diseases_list": [ - "Familial Mediterranean Fever" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Fulfilling the Tel Hashomer criteria for the diagnosis of FMF [5]. \n\n Suffering from episodes of exertional leg pain and or exertional ankle edema \n\n 18-45 years old \n\n On a stable (\u2265 2 weeks) dose of oral colchicine therapy \n\n Non-smokers \n\n ", - "exclusion_criteria": ": \n\n with known peripheral vascular disease (PVD) and/or multiple risk factors for PVD (such as diabetes, hypertension, hyperlipidemia) \n\n Suffering from muscular or neurological diseases not related to FMF \n\n With elevated serum creatinine / liver enzymes/ creatine phosphokinase (CPK) levels. \n\n Suffering from claustrophobia, or with metal fragments in body tissue, or with other contraindications for MRI.", - "brief_summary": "Familial Mediterranean fever (FMF) is an inherited disorder of unknown etiology, characterized by recurrent episodes of fever, peritonitis and/or pleuritis.~Fever is the cardinal manifestation of FMF and is present in most attacks accompanied by abdominal pain.~Another clinical manifestation in patients with FMF is exertional muscle pain, usually in the thigh, which appears even after minor exercise or physical activity in young patients with generally good health (other than FMF) and in good physical condition. Some patients also complain of ankle edema after relatively minor physical activity, which subsides after a night rest. Although these manifestations are quite common in FMF patients and form part of the minor criteria for the diagnosis, the etiopathogenesis has not been examined.~The purpose of the suggested study is to evaluate and characterize the anatomical and biochemical changes in the muscles of the thigh and in the ankle triggered by physical activity in FMF patients complaining of exertional lower leg myalgias and edema after minor physical exercise.", - "NCTID": "NCT00658060" - }, - { - "brief_title": "Treatment of Viral Hemorrhagic Fevers With Intravenous Ribavirin in Military Treatment Facilities", - "phase": "Phase 2", - "drugs": "['Ribavirin (Virazole) Injection']", - "drugs_list": [ - "Ribavirin (Virazole) Injection" - ], - "diseases": "['Lassa Fever', 'Crimean-Congo Hemorrhagic Fever']", - "diseases_list": [ - "Lassa Fever", - "Crimean-Congo Hemorrhagic Fever" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n An individual will be enrolled in this study if the patient: \n\n Meets the case definition for a probable or a suspected case of CCHF or LF (see below). \n\n Has read and signed the Informed Consent. \n\n Is at least 18 years of age (17, if active military) and not greater than 65 years of age. \n\n Has a blood sample drawn and a type and cross-match ordered for transfusion. \n\n Agrees to collection of required specimens. \n\n Agrees to report any Adverse Events, Serious and Unexpected Adverse Events for the duration of the study. \n\n Agrees to a follow-up visit and to donate blood and urine specimens at day 14 (\u00b12 days) and once between days 28 and 60 after the first dose of IV Ribavirin and to all follow-up visits for anemia or other medical conditions as required by the attending physician. \n\n Woman of childbearing age must have a pregnancy test performed. If negative, she must agree not to become pregnant during treatment and for 7 months after receiving Ribavirin. She also must agree to not breast feed during treatment and for 7 months after receiving Ribavirin. Two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period. She will be counseled concerning the risks of IV Ribavirin versus no treatment if the pregnancy test is positive. \n\n Man agrees not to have intercourse with pregnant woman during treatment and for 7 months after receiving Ribavirin, and take precautions to avoid producing pregnancies during treatment and for 7 months after receiving Ribavirin. At least two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period to avoid a pregnancy. \n\n Has a hemoglobin greater than or equal to10 g/dL before starting IV Ribavirin \n\n Note: Malaria should be excluded as a possibility for illness in patients suspected to have VHF. \n\n Probable Case of Crimean-Congo Hemorrhagic Fever: \n\n All subjects will have a history of possible exposure to CCHF, either having: \n\n Worked or slept outdoors in the CCHF endemic area within 2 weeks of illness onset, with or without a history of tick-bite or tick exposure, (Endemic area includes, but not necessarily limited to: Saudi Arabia, Kuwait, Oman, United Arab Emirates, Iran, Iraq, Turkey, Greece, Bulgaria, Albania, Montenegro, the Kosovo region of Serbia, Bosnia-Herzegovina, Macedonia, the whole of Africa, India, Pakistan, Afghanistan, Kazakhstan, Uzbekistan, Kyrgyzstan, Tajikistan, Turkmenistan, Azerbaijan, Georgia, the Crimean region of the Ukraine, Rostov-Don and Astrakhan regions of Russia, and the Xinjiang [northwestern] region of the People's Republic of China), OR \n\n Handled blood or freshly butchered meat of domestic livestock in CCHF endemic area during 2 weeks before the onset of illness, OR \n\n Had direct contact with blood, tissues, secretions, or excretions of a CCHF patient (suspected or confirmed), including laboratory specimens, OR \n\n Worked with the virus in the laboratory setting and have a clinical syndrome consistent with CCHF as defined by: \n\n Acute illness with fever and at least two of these symptoms: myalgia, low back pain, and headache, \n\n And the appearance of three or more of the following five groups of signs/symptoms: \n\n Hemorrhage (one or more petechiae, ecchymoses, purpura, gingival bleeding, epistaxis, gastrointestinal tract bleeding), \n\n Elevated AST levels (above the upper limits of normal for the laboratory), \n\n Thrombocytopenia (below the lower limits of normal), \n\n Hypotension (systolic pressure < 90 mm Hg), or \n\n Azotemia, renal failure (serum creatinine above the upper limits of normal). \n\n Prognostic indicators exist for subjects at increased risk of severe CCHF. Any of these indicators occurring in the first 5 days of illness, predict a mortality greater than 90% (Swanepoel et al., 1989). Patients with these prognostic indicators may benefit most from drug therapy, if resources become limiting: \n\n WBC > 10,000/mm3 \n\n Platelet count < 20 x 103/mm3 \n\n AST > 200 U/L \n\n ALT > 150 U/L \n\n APTT > 60 seconds \n\n Fibrinogen < 110 mg/dL \n\n Probable Case of Lassa Fever: \n\n All subjects will have a history of possible exposure to Lassa fever, either having: \n\n By residence or travel in an endemic area where contact with rodents was possible within 3 weeks of onset of illness, (Endemic area includes, but not necessarily limited to: Sierra Leone, Liberia, Nigeria, Mali, Central African Republic, and Guinea.) or \n\n Contact with a suspect patient or their body fluids (including laboratory specimens) within 3 weeks of symptom onset, or \n\n Worked with the virus in the laboratory setting. And have \n\n A negative malaria smear. And have \n\n Signs and symptoms compatible with Lassa fever, either: \n\n Fever plus pharyngitis plus retrosternal pain plus proteinuria (positive predictive value of 81% when these three criteria are met, McCormick et al., 1987a,b),OR \n\n Fever plus unexplained mucosal bleeding, OR \n\n Fever plus unexplained edema of the face and neck, OR \n\n Suspected Case of CCHF or LF \n\n Have a clinical syndrome consistent with CCHF or LF, meeting most of the above criteria of a probable case and the patient has an epidemiological history of potential exposure to the bunyavirus or arenavirus (i.e., recent field duty and/or other individuals in his troop have CCHF or LF). \n\n ", - "exclusion_criteria": ": \n\n Has known intolerance to Ribavirin. \n\n Is irreversibly ill on presentation, as defined by presence of profound shock (shock which does not respond to supportive therapy within 3 hours after admission). \n\n Has hemoglobin less than 10 g/dL that cannot be corrected to 10 g/dL before initiation of IV Ribavirin \n\n Has history of hemoglobinopathies (i.e., sickle-cell anemia or thalassemia major). \n\n Has history of autoimmune hepatitis. \n\n Has a calculated serum creatinine clearance of < 30 mL/min. \n\n History of such as second or third degree heart block or sick sinus syndrome and without a pacemaker and no capability of a pacemaker placement or Wolfe-Parkinson-White Syndrome. \n\n A sinus bradycardia of less than 40 beats per minute. \n\n Is currently being treated with Didanosine (ddI). ddI must be discontinued before starting IV Ribavirin. \n\n Relative ", - "brief_summary": "This is a Phase 2 study of the safety and efficacy of Intravenous (IV) Ribavirin in treating patients presenting with a probable or suspected case of viral hemorrhagic fever (either Crimean Congo or Lassa Fever) at a military medical treatment hospital. All patients will be treated with a 10 day course of IV Ribavirin if they meet all the inclusion and none of the exclusion criteria.", - "NCTID": "NCT00992693" - }, - { - "brief_title": "Home Oxygen Treatment of Childhood Acute Bronchiolitis", - "phase": "", - "drugs": "['Home oxygen therapy']", - "drugs_list": [ - "Home oxygen therapy" - ], - "diseases": "['Bronchiolitis, Viral', 'Home Nursing']", - "diseases_list": [ - "Bronchiolitis", - "Viral", - "Home Nursing" - ], - "enrollment": "85.0", - "inclusion_criteria": "inclusion criteria: \n\n Age: 2-24 months, but age postconception of over 44 weeks. \n\n Ac. bronchiolitis clinical diagnosis: acute respiratory illness including nasal congestion, coughing and wheezing or crackles simplified, Tachypnea or retractions of the chest. \n\n X-ray confirms a viral diagnosis of bronchiolitis \n\n First attack of wheezing \n\n O2 Saturation < 91% room air while arrival to the ER \n\n The baby and his family have a way to return to the ER after discharge \n\n The family lives a distance of less than 30 minutes drive from the center of Emergency Medicine \n\n The baby lives in an environment with no smoking \n\n The baby's family is available by phone \n\n The baby's family is ready for continuous monitoring of the baby at home 11th. Disease severity index (RDSS) of < 4 (see definitions) \n\n ", - "exclusion_criteria": ": \n\n Previous morbidity: cardiac, pulmonary, neuromuscular, nutrition (including FTT). And congenital or acquired airway problem. \n\n Age since conception is less than -44 weeks. \n\n History of apneas \n\n Bacterial pneumonia suggested by a localized-focal finding on X-ray \n\n Previous wheezing attack \n\n O2 Saturation > 92% on room air \n\n Family has no transportation available follow-up visits \n\n The family lives at a distance greater than 30 minutes drive from the medical facility \n\n The baby was treated with steroids for this attack \n\n There is no continuous monitoring of the baby at home", - "brief_summary": "Background: acute bronchiolitis (AB) is a common reason for hospitalization of infants in all population groups, and is usually due to respiratory syncytial virus (RSV) infection. The main cause for hospitalization is often a need for oxygen, but can also include high fever (with a suspected secondary bacterial infection) or increasing respiratory distress. In a minority of cases (some of which can be identified in advance by defining risk groups) a serious illness may develop, including risk of respiratory failure and death. Most cases will just require supplemental oxygen and suction of secretions from the nose (as listed in the recommendations of the American Academy of Pediatrics - AAP). However, this apparently simple treatment still requires continued hospitalization. This results in a sharp increase in bed occupancy in Israeli hospital pediatric departments in the winter months. In recent years two studies from developed countries have been published where safety has been demonstrated for home oxygen treatment for babies with AB. However, feasibility studies have not been published yet, for example for populations living in poor conditions. The General Health Services (Klalit) in Israel provides integrated hospital and community health service to the majority of the population living o in our region, thus presenting an opportunity for optimal interventions related to this disease.", - "NCTID": "NCT01618175" - }, - { - "brief_title": "Controlled Trial: 5-day Course of Rifampin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus", - "phase": "", - "drugs": "['doxycycline', 'rifampin']", - "drugs_list": [ - "doxycycline", - "rifampin" - ], - "diseases": "['Scrub Typhus']", - "diseases_list": [ - "Scrub Typhus" - ], - "enrollment": "476.0", - "inclusion_criteria": "inclusion criteria: \n\n inclusion criteria were: \n\n Adults aged 18 years or older \n\n A fever of higher than 37.5\u00b0C \n\n The concurrent presence of eschar or a maculopapular skin rash; and the clear presence of more than two symptoms such as headache, malaise, myalgia, coughing, nausea and abdominal discomfort. \n\n Patients were hospitalized at Chosun University Hospital in Kwangju, Korea or one of its two community-based affiliated hospitals which are all located in southwestern Korea between 2006 and 2009. \n\n ", - "exclusion_criteria": ": \n\n The ", - "brief_summary": "New antibiotics are required to have not only the antibacterial activity against doxycyline-resistant O. tsutsugamushi but also lower risk for resistance or any cross-resistance to others.~In this prospective, open-label, randomized trial, we enroll patients with mild-to-moderate scrub typhus. We compared the efficacy and safety of a 5-day rifampin therapy with those of a 5-day doxycycline therapy at Chosun University Hospital, or one of its two community-based affiliated hospitals which are all located in southwestern Korea between 2006 and 2009.", - "NCTID": "NCT00568711" - }, - { - "brief_title": "The Sero-Prevalence and Genetic Study for the Infectious Diseases and Metabolic Syndrome in Solomon Islands", - "phase": "", - "drugs": "['diagnosis, treatment and education']", - "drugs_list": [ - "diagnosis", - "treatment and education" - ], - "diseases": "['Flavivirus Infection', 'Alphavirus Infections', 'Malaria', 'Parasitic Disease', 'Leptospirosis', 'Hypertension', 'Metabolic Syndromes']", - "diseases_list": [ - "Flavivirus Infection", - "Alphavirus Infections", - "Malaria", - "Parasitic Disease", - "Leptospirosis", - "Hypertension", - "Metabolic Syndromes" - ], - "enrollment": "1477.0", - "inclusion_criteria": "inclusion criteria: \n\n For community participants: Health volunteers who are willing to join this study (including the stool and blood testing) after explanation and sign the informed consents. \n\n For hospital cases: The patients ,who were suspicious of malaria, leptospirosis, Alpha-viral(Chikungunya virus, Ross river virus), and flavivirus infections (dengue fever, Japanese encephalitis..ect) by the attending physicians, will be informed about this study by drawing blood samples if they agree to participate. \n\n ", - "exclusion_criteria": ": \n\n The participants whose stool or blood samples were in-adequate or missing will be excluded from this study. \n\n The participants whose documented personal information is fake or cannot be identifiable will also be excluded from this study.", - "brief_summary": "The study project can be divided into two parts: (1) health screening for the community and (2) clinical diagnosis and treatment for patients at National Referral Hospital (NRH) in Solomon islands. The health screening includes a questionnaire, stool parasitic screening and blood laboratory tests. A total of 800 subjects will participate in this study. The collected samples are venous blood (20 ml/per subject) and stool in order to conduct the related tests mentioned above.~As for the collection of target patients, KMUH will cooperate with NRH to collect two kinds of blood samples: the blood samples of confirmed malarial cases and those of cases suspicious of Flaviviral, Alpha-viral, Rickettsial, and Leptospiral infections. The expected received cases are 600 each year. The venous blood samples (20 ml/per subject) will be used to conduct related tests mentioned above. At the same time, the subjects will also have to fill out a related questionnaire which includes height, weight, waist line, heath behavior and habit, and past history, etc.", - "NCTID": "NCT01080989" - }, - { - "brief_title": "Experimental Vaccine for Prevention of Ebola Virus Infection", - "phase": "Phase 1", - "drugs": "['VRC-EBOADV018-00-VP']", - "drugs_list": [ - "VRC-EBOADV018-00-VP" - ], - "diseases": "['Ebola Hemorrhagic Fever', 'Ebola Virus Disease', 'Ebola Virus Vaccines', 'Envelope Glycoprotein, Ebola Virus', 'Filovirus']", - "diseases_list": [ - "Ebola Hemorrhagic Fever", - "Ebola Virus Disease", - "Ebola Virus Vaccines", - "Envelope Glycoprotein", - "Ebola Virus", - "Filovirus" - ], - "enrollment": "48.0", - "inclusion_criteria": "inclusion criteria: \n\n A subject must meet all of the following criteria: \n\n 18 to 50 years old. \n\n Available for clinical follow-up through Week 48. \n\n Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. \n\n Complete an AoU prior to enrollment and verbalize understanding of all questions answered incorrectly. \n\n Able and willing to complete the informed consent process. \n\n Willing to donate blood for sample storage to be used for future research. \n\n In good general health without clinically significant medical history. \n\n Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) less than 40 within the 28 days prior to enrollment. \n\n Laboratory Criteria within 28 days prior to enrollment: \n\n Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to 13.5 g/dL for men \n\n White blood cells (WBC) equal to 3,300-12,000 cells/mm(3) \n\n Differential either within institutional normal range or accompanied by site physician approval \n\n Total lymphocyte count greater than or equal to 800 cells/mm(3) \n\n Platelets equal to 125,000 - 400,000/mm(3) \n\n Alanine aminotransferase (ALT) less than or equal to 1.25 upper limit of normal \n\n Serum creatinine less than or equal to 1 x upper limits of normal (less than or equal to 1.3 mg/dL for females; less than or equal to 1.4 mg/dL for males) \n\n Normal urinalysis defined as negative glucose, negative or trace protein and no clinically significant blood in the urine. \n\n Negative FDA-approved HIV blood test, at low risk of HIV exposure as assessed by behavioral risk interview, and amenable to HIV risk reduction counseling. [Note: Results of HIV ELISA will be documented, but a negative HIV polymerase chain reaction (PCR) test result will be sufficient for eligibility screening of subjects with positive HIV ELISA that is due to prior participation in an HIV vaccine study] \n\n Negative hepatitis B surface antigen (HBsAg) \n\n Negative anti-HCV and negative hepatitis C virus (HCV) PCR. \n\n a PTT within institutional normal range and PT less than or equal to upper limit of institutional normal range. \n\n Female-Specific Criteria: \n\n Negative beta-HCG pregnancy test (urine or serum) for women presumed to be of reproductive potential. \n\n A female participant must meet one of the following criteria: \n\n No reproductive potential because of menopause [one year without menses] or because of a hysterectomy, bilateral oophorectomy, or tubal ligation, OR \n\n Participant agrees to be heterosexually inactive at least 21 days prior to enrollment and through Week 24 of the study, OR \n\n Participant agrees to consistently practice contraception at least 21 days prior to enrollment and through Week 24 of the study by one of the following methods: \n\n condoms, male or female, with or without a spermicide \n\n diaphragm or cervical cap with spermicide \n\n intrauterine device \n\n contraceptive pills or patch, Norplant, Depo-Provera or any other FDA-approved contraceptive method \n\n male partner has previously undergone a vasectomy. \n\n ", - "exclusion_criteria": ": \n\n A subject will be excluded if one or more of the following conditions apply. \n\n Women: \n\n Breast-feeding or planning to become pregnant during the first 24 weeks after enrollment. \n\n Subject has received any of the following substances: \n\n Ebola vaccines or any recombinant adenoviral vector vaccine in a prior clinical trial. \n\n Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past six months. [Note: that use of corticosteroid nasal spray for allergic rhinitis, topical corticosteroids for an acute uncomplicated dermatitis, or short-acting beta-agonists in controlled asthmatics are not excluded.] \n\n Blood products within 120 days prior to HIV screening \n\n Immunoglobulin within 60 days prior to HIV screening \n\n Live attenuated vaccines within 30 days prior to initial study vaccine administration \n\n Investigational research agents within 30 days prior to initial study vaccine administration \n\n Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration \n\n Current anti-tuberculosis prophylaxis or therapy \n\n Subject has a history of any of the following clinically significant conditions: \n\n Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain \n\n Idiopathic urticaria within the past 2 years \n\n Autoimmune disease or immunodeficiency \n\n Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or parenteral corticosteroids. \n\n Diabetes mellitus (type I or II), with the exception of gestational diabetes. \n\n History of thyroidectomy or thyroid disease that required medication within the past 12 months. \n\n A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema. \n\n Hypertension that is not well controlled by medication or blood pressure that is more than 145/95 at enrollment. \n\n Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions), significant bruising or bleeding difficulties with IM injections or blood draws, or use of anticoagulant medications. \n\n Malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of the study. \n\n Seizure disorder other than: 1) febrile seizures under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring treatment within the last 3 years. \n\n Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen. \n\n Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within 5 years prior to enrollment, a history of suicide plan or attempt. \n\n Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a subject's ability to give informed consent. \n\n A family history of pulmonary embolism associated with deep vein thrombosis without a known cause (such as hormonal contraceptive use or neoplasm) in a biologically related parent, sibling, child under the age of 60 years, or a family history of systemic lupus erythematosus in a biologically related parent, sibling, or child of any age.", - "brief_summary": "This study will determine if an experimental vaccine to prevent Ebola virus infection is safe and what side effects, if any, it causes. Ebola virus infection may range from mild to severe, and may cause breathing problems, severe bleeding, kidney problems and shock that can lead to death. The vaccine used in this study contains man-made genetic material similar to one part of the Ebola virus, which is designed to stimulate an immune response to the virus. The vaccine itself cannot cause Ebola virus infection because it does not contain any Ebola virus.~Participants are assigned to one of three groups as they enter into the study. Of the first 16 people in the study, 12 receive the lowest study dose of vaccine and 4 receive placebo (an inactive substance). If this dose is safe, then of the next 16 people who enter the study, 12 receive a higher dose of the vaccine, and the remaining 4 receive placebo. If this dose is safe, the final 12 people in the last group of 16 receive the highest study dose, and 4 receive placebo. The vaccine is given as a single injection in the arm on the day of enrollment.~Participants keep a diary for 5 days, recording their temperature, symptoms and any reaction at the injection site. They call a study nurse the day after vaccination to report how they feel, and they return to the clinic approximately six times for follow-up evaluations. These visits may include a check of vital signs, physical examination, blood and urine tests, or other medical tests if needed.~...", - "NCTID": "NCT00374309" - }, - { - "brief_title": "The Study of Drotrecogin Alfa (Activated) in a Subpopulation of Adult Patients With Severe Sepsis", - "phase": "Phase 4", - "drugs": "['Drotrecogin alfa (activated)']", - "drugs_list": [ - "Drotrecogin alfa (activated)" - ], - "diseases": "['Sepsis']", - "diseases_list": [ - "Sepsis" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Adult patients with severe sepsis. \n\n Presence of a suspected or proven infection. \n\n One or more sepsis-associated organ failure. \n\n ", - "exclusion_criteria": ": \n\n Are indicated for the treatment with drotrecogin alfa (activated) in the investigative site country. \n\n Are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country. \n\n Platelet count <30,000/mm3. \n\n Are receiving therapeutic heparin.", - "brief_summary": "Severe sepsis is defined as a systemic inflammatory response syndrome that results from infection and is associated with acute organ dysfunction. It usually results from bacterial infections, but it may occur in response to other pathogens, such as fungi, viruses, and parasites.", - "NCTID": "NCT00045760" - }, - { - "brief_title": "Monitoring the Efficacy of Anthelmintics for the Treatment of Soil Transmitted Helminths P2", - "phase": "Phase 4", - "drugs": "['Mebendazole']", - "drugs_list": [ - "Mebendazole" - ], - "diseases": "['Ascaris Lumbricoides', 'Ascaris Suum', 'Trichuris Trichiura', 'Trichuris Vulpis', 'Ancylostoma Duodenal', 'Ancylostoma Caninum', 'Ancylostoma Ceylanicum', 'Necator Americanus']", - "diseases_list": [ - "Ascaris Lumbricoides", - "Ascaris Suum", - "Trichuris Trichiura", - "Trichuris Vulpis", - "Ancylostoma Duodenal", - "Ancylostoma Caninum", - "Ancylostoma Ceylanicum", - "Necator Americanus" - ], - "enrollment": "250.0", - "inclusion_criteria": "", - "exclusion_criteria": ": \n\n Subjects who are unable to provide a stool sample at follow-up \n\n Subjects who are experiencing a severe concurrent medical condition \n\n Subjects with diarrhea at first sampling", - "brief_summary": "Objectives:~The overall objective is to monitor efficacy of mebendazole (MBZ) against Soil-Transmitted Helminths (STH).~The primary objective is:~(1) to monitor the efficacy a single dose 500 mg of mebendazole (MBZ) against Soil-Transmitted Helminths (STH) infections by means of Faecal Egg Count Reduction (FECR) and Cure Rate (CR).~The secondary objectives are:~to assess the occurrence of Necator americanus and Ancylostoma duodenal.~to assess the occurrence of \u03b2-tubulin mutations related to resistance before and after drug administration.~to evaluate the role of dogs and pigs as reservoir for zoonotic transmission.", - "NCTID": "NCT01379326" - }, - { - "brief_title": "Ability of Bedside Ultrasound to Predict Progression of Severity of Disease in Dengue Fever", - "phase": "", - "drugs": "['diagnostic bedside ultrasound']", - "drugs_list": [ - "diagnostic bedside ultrasound" - ], - "diseases": "['Dengue', 'Disease Progression']", - "diseases_list": [ - "Dengue", - "Disease Progression" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Age >3 months and <16 years \n\n Clinical suspicion of dengue hemorrhagic fever. (Revised WHO Classification System) \n\n Not a prisoner or ward of the state \n\n Parents able and willing to give consent. Children older then 7 able and willing to give assent \n\n ", - "exclusion_criteria": ": \n\n Allergic to Ultrasound gel \n\n Prisoners or wards of the state \n\n Unstable patients \n\n Known pleural effusion, ascites, or gallbladder wall thickening.", - "brief_summary": "The purpose of this study is determine the ability of bedide ultrasound performed in the Emergency Department and Outpatient Department can predict the severity of disease during a Dengue Fever outbreak in children, in Siem Reap, Cambodia. Our hypothesis is that the presence of gallbladder wall thickening and/or pleural effusions in children correlates with progression to Dengue hemorrhagic fever and Dengue shock. In addition, we hypothesize that sonographic imaging of pediatric patients presenting to the emergency department with a fever during a Dengue fever outbreak will change management and disposition.", - "NCTID": "NCT02134652" - }, - { - "brief_title": "Seroepidemiology of Japanese Encephalitis Virus Infection in Hualien, Taiwan", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Japanese Encephalitis']", - "diseases_list": [ - "Japanese Encephalitis" - ], - "enrollment": "312.0", - "inclusion_criteria": "inclusion criteria: \n\n Living in the specific 2 villages in Hualien county \n\n Aged 18-85 \n\n ", - "exclusion_criteria": ": \n\n 1. Difficulty to have blood test due to coagulopathy or small blood vessels", - "brief_summary": "Japanese encephalitis (JE) is one of important zoonotic infectious diseases in Taiwan. JE caused by Japanese encephalitis virus (JEV) which transmitted by Culex tritaeniorhynchus and used swine as amplifying host. Infections leading to overt encephalitis are estimated to be 1 in 1000 cases. Among JE confirmed cases, approximately 25 percent of cases die and 50 percent of the survivals develop permanent neurologic and/or psychiatric sequelae. JEV circulated in Taiwan are belonged to genotype III and the vaccine strain selected from same genotype. Genotype I JEV was first detected in northern Taiwan in 2008 by CDC, and the same genotype JEV were detected in mosquito collected in central Taiwan by our group. In order to study the genotypic shift of JEV in Taiwan areas, and the effects of the replacement of genotype on vaccine, we will conduct the JEV seroepidemiology in Hualien county which was the highest incidence of JEV in Taiwan. The aims of this study were: (1) study the circulating of genotype I JEV in Hualien county; (2) determine the virulence of genotype I JEV in human; (3) differential diagnosis of JEV genotype I or III infection among confirmed cases; (4) measure the cross neutralizing activity, after immunized with genotype III JEV vaccine, against genotype I JEV; (5) determine the age-specific seroprevalence of JEV antibody; (6) estimate the annual risk of infection for JEV.", - "NCTID": "NCT01163123" - }, - { - "brief_title": "Livestock Contact and MRSA in Rural Areas", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Staphylococcus Aureus Infection']", - "diseases_list": [ - "Staphylococcus Aureus Infection" - ], - "enrollment": "1342.0", - "inclusion_criteria": "inclusion criteria: \n\n Cohort A: Participant or child of participant in the Agricultural Health Study \n\n Cohort B: Resident of Iowa \n\n ", - "exclusion_criteria": ": \n\n Cohort A: Age <8 months \n\n Cohort B: Age <8 months", - "brief_summary": "Background:~- MRSA is a type of bacteria that causes serious health problems. It can cause severe infections and is difficult to treat. MRSA has been found in a high number of people who work with some kinds of livestock, such as pigs. Researchers want to study people in rural areas, where more people work with or around livestock. They want to see if MRSA is more common or causes more serious infections in these areas.~Objectives:~- To look at the relationship between livestock handling (especially pigs) and MRSA bacteria in people in rural areas.~Eligibility:~Participants in the Agricultural Health Study in Iowa, including those who are exposed to livestock.~Healthy volunteers who are not exposed to livestock.~Design:~This study requires an initial visit and monthly follow-up surveys for 18 months.~At the first visit, participants will have throat and nose swabs to collect cell and bacteria samples. They will also complete a questionnaire about their health habits. Other questions will ask about any work that brings them into contact with livestock like cows, pigs, or chickens.~Every month for the next 17 months, participants will complete another questionnaire to record any changes in their health and livestock contact information. They will also collect throat and nose swabs. They will send the questionnaires and the swabs to the study researchers.~Participants will be paid for the first visit and for every monthly survey and swab collection they return.~No treatment will be given as part of this protocol.", - "NCTID": "NCT01375621" - }, - { - "brief_title": "Epidemiology and Pulmonary Response To Organic Dust Exposure", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Lung Diseases, Obstructive', 'Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Lung Diseases", - "Obstructive", - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "", - "inclusion_criteria": "No eligibility criteria", - "exclusion_criteria": "", - "brief_summary": "To characterize the nature of pulmonary responses to organic dust exposures in order to gain insight into patterns of respiratory disease in agricultural workers.", - "NCTID": "NCT00005288" - } - ], - "1": [ - { - "brief_title": "Rapid Diagnostic Tests and Clinical/Laboratory Predictors of Tropical Diseases In Patients With Persistent Fever in Cambodia, Nepal, Democratic Republic of the Congo and Sudan (NIDIAG-Fever)", - "phase": "", - "drugs": "['rk28 ICT', 'IT LEISH (rK39)', 'Immunochromatographic HAT test', 'HAT Serostrip', 'Card Agglutination Trypanosoma Test (CATT)-10', 'Typhidot M', 'S. typhi IgM/IgG', 'Test-it Typhoid IgM', 'Test-it Leptospirosis IgM', 'Leptospira IgG/IgM']", - "drugs_list": [ - "rk28 ICT", - "IT LEISH (rK39)", - "Immunochromatographic HAT test", - "HAT Serostrip", - "Card Agglutination Trypanosoma Test (CATT)-10", - "Typhidot M", - "S. typhi IgM/IgG", - "Test-it Typhoid IgM", - "Test-it Leptospirosis IgM", - "Leptospira IgG/IgM" - ], - "diseases": "['Visceral Leishmaniasis', 'Human African Trypanosomiasis', 'Enteric Fever', 'Melioidosis', 'Brucellosis', 'Leptospirosis', 'Relapsing Fever', 'Rickettsial Diseases', 'HIV', 'Tuberculosis', 'Malaria', 'Amoebic Liver Abscess']", - "diseases_list": [ - "Visceral Leishmaniasis", - "Human African Trypanosomiasis", - "Enteric Fever", - "Melioidosis", - "Brucellosis", - "Leptospirosis", - "Relapsing Fever", - "Rickettsial Diseases", - "HIV", - "Tuberculosis", - "Malaria", - "Amoebic Liver Abscess" - ], - "enrollment": "1927.0", - "inclusion_criteria": "inclusion criteria: \n\n fever for \u2265 1 week \n\n \u2265 5 years old (18 years onward in Cambodia) \n\n ", - "exclusion_criteria": ": \n\n unwilling or unable to give written informed consent \n\n unable in the study physician's opinion to comply with the study requirements \n\n existing laboratory confirmed diagnosis \n\n need of immediate intensive care due to shock or respiratory distress", - "brief_summary": "Tropical fevers have been a diagnostic challenge from the antiquity. Nowadays, despite the availability of good diagnostic capacities, undifferentiated febrile illnesses continue to be a thorny problem for travel physicians. In developing countries, the scarcity of skilled personnel and adequate laboratory facilities makes the differential diagnosis of fevers even more complex. Health care workers must often rely on syndrome-oriented empirical approaches to treatment and might overestimate or underestimate the likelihood of certain diseases. For instance Neglected Tropical Diseases (NTD) contribute substantially to the burden of persistent (more than 1 week) fevers in the Tropics, causing considerable mortality and major disability. These diseases are however rarely diagnosed at primary health care (PHC) level. The difficulty in establishing the cause of febrile illnesses has resulted in omission or delays in treatment, irrational prescriptions with polytherapy, increasing cost and development of drug resistance.~In resource-limited settings, clinical algorithms constitute a valuable aid to health workers, as they facilitate the therapeutic decision in the absence of good laboratory capacities. There is a critical lack of appropriate diagnostic tools to guide treatment of NTDs. While clinical algorithms have been developed for some NTDs, in most cases they remain empirical. Besides, they rarely take into account local prevalence data, do not adequately represent the spectrum of patients and differential diagnosis at the primary care level and often have not been properly validated. The purpose of the study is to develop evidence-based Rapid Diagnostic Test (RDT)-supported diagnostic guidelines for patients with persistent fever (\u2265 1 week) in the Democratic Republic of the Congo (DRC), Sudan, Cambodia and Nepal.", - "NCTID": "NCT01766830" - } - ], - "2": [] - }, - { - "patient_id": "sigir-201510", - "patient": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", - "0": [ - { - "brief_title": "Menstrual Effects On Mood Symptoms in Bipolar Disorder", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Bipolar Disorder']", - "diseases_list": [ - "Bipolar Disorder" - ], - "enrollment": "45.0", - "inclusion_criteria": "inclusion criteria: \n\n Ages 18-45; \n\n Bipolar Disorder (BD) I or II (DSM-IV criteria) must agrees to communication between PI and Psychiatrist; \n\n Healthy Control without Past or Current Major Depression, Psychotic Disorder, premenstrual syndrome or Premenstrual Dysphoric Disorder; \n\n 25-31day menstrual cycles; \n\n Minimum 6 menstrual cycles per year \n\n ", - "exclusion_criteria": ": \n\n Current DSM-IV Criteria Alcohol or Substance Abuse/Dependence; \n\n Pregnancy; \n\n Chronic Anovulation (<4 menstrual cycles/yr); \n\n Menopause (< 1menses in 1yr); \n\n Active thyroid disease; \n\n Hormonal Contraception", - "brief_summary": "Background and Rationale for Study: Estrogen and progesterone are female hormones that regulate the menstrual cycle and likely serve an important role in the regulation of mood. Premenstrual Syndrome (PMS) which affects 75% of healthy women is a cyclic pattern of mild dysphoria and physical discomfort that begin 1-2weeks pre-menses, and resolve by 2-3 days post-onset of menses. Up to 66% of women with bipolar disorder (BD) describe premenstrual mood changes that range from mild symptoms to severe worsening that require hospitalization. Therefore, the hormonal shifts of the menstrual cycle likely influence bipolar symptoms, but confirmatory research is lacking.~Study questions: The primary aims and hypotheses are to characterize bipolar mood symptoms throughout the menstrual cycle and to determine if women with BD have: 1) a) increased severity and persistence of depression and mania symptoms in the late luteal (premenstrual) vs early follicular phase, b) larger change in mood symptoms from the late luteal (premenstrual) to the early follicular phase, compared to healthy women, 2) more relapses, in the late luteal compared to the early follicular phase. The secondary aims are to determine: 1) frequency and severity of premenstrual dysphoric disorder (PMDD) type symptoms in bipolar women; 2) association between bipolar mood variability and a) menstrual phase, b) ovulatory vs anovulatory cycles, c) antimanic drug treatment.", - "NCTID": "NCT00472615" - }, - { - "brief_title": "Studies in Porphyria IV: Gonadotropin-Releasing Hormone (GnRH) Analogues for Prevention of Cyclic Attacks", - "phase": "", - "drugs": "['luteinizing hormone-releasing factor']", - "drugs_list": [ - "luteinizing hormone-releasing factor" - ], - "diseases": "['Porphyria']", - "diseases_list": [ - "Porphyria" - ], - "enrollment": "", - "inclusion_criteria": "PROTOCOL ENTRY CRITERIA: \n\n --Disease Characteristics-- Acute porphyria, i.e.: Acute intermittent porphyria Hereditary coproporphyria Variegate porphyria Definite cyclic attacks with severe abdominal pain and other porphyria symptoms during luteal phase of menstrual cycle only Attacks resolve completely within 5 days of onset of menses, i.e., no symptoms between attacks At least 4 to 6 attacks during the 6 months prior to entry More than half of these attacks must meet the following criteria: Readily distinguishable from menstrual cramps and premenstrual syndrome Required hospitalization for narcotic analgesics, phenothiazines, hematin, intravenous fluids, or other treatment Luteal attacks not requiring hospitalization must be similar in symptoms and differ only in severity No life-threatening porphyria attacks No cyclic abdominal pain unless caused by porphyria --Prior/Concurrent Therapy-- At least 6 months since ovulation suppression --Patient Characteristics-- Reproductive: Menstrual cycle 25-35 days for at least 6 months prior to entry Pelvic exam normal within 60 days prior to entry Pap smear normal, i.e., no dysplasia No amenorrhea No other menstrual abnormality No other gynecologic abnormality Negative pregnancy test Medically approved contraception required for 2 months prior to entry and throughout study OR at least 1 menstrual cycle following tubal ligation Other: No allergy to gonadotropin-releasing hormone analogues No clinically significant abnormal laboratory test results No medical contraindication to protocol treatment", - "exclusion_criteria": "", - "brief_summary": "OBJECTIVES:~Assess whether chronic administration of gonadotropin-releasing hormone analogues is safe and effective for the prevention of cyclic attacks of acute porphyria in women.", - "NCTID": "NCT00004330" - }, - { - "brief_title": "A Treatment Study for Premenstrual Syndrome (PMS)", - "phase": "Phase 1", - "drugs": "['Leuprolide', 'Estradiol Patches', 'Progesterone', 'Placebo patch', 'Placebo injection', 'Placebo suppository']", - "drugs_list": [ - "Leuprolide", - "Estradiol Patches", - "Progesterone", - "Placebo patch", - "Placebo injection", - "Placebo suppository" - ], - "diseases": "['Premenstrual Syndrome', 'Menstruation Disturbances']", - "diseases_list": [ - "Premenstrual Syndrome", - "Menstruation Disturbances" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n The subjects of this study will be women who meet the criteria for MRMD as described in Protocol No. 81-M-0126, 'The Phenomenology and Biophysiology of Menstrually-related Mood and Behavioral Disorders.' In brief, these criteria include: \n\n history within the last two years of at least six months with menstrually-related mood or behavioral disturbances of at least moderate severity--i.e., disturbances that are distinct in appearance and associated with a notable degree of subjective distress; \n\n symptoms should have a sudden onset and offset; \n\n age 18-50; \n\n not pregnant and in good medical health; \n\n medication free. \n\n All patients participating in this protocol will have already participated in Protocol No. 81-M-0126 and will have a prospectively confirmed and predictable relationship between their mood disorder and the premenstrual phase of the menstrual cycle, i.e., a 30% change in severity of symptom self rating scales, relative to the range of the scale employed, during the seven days premenstrually compared with the seven days post-menstrually in two out of three months of study. \n\n The Schedule for Affective Disorders and Schizophrenia will be administered to all patients prior to study entry. Any patient with a current axis I psychiatric diagnosis will be excluded from participating in this protocol. \n\n Prior to treatment, a complete physical and neurological examination will have been performed and the following routine laboratory data obtained: \n\n A. Blood \n\n Complete blood count; thyroid function tests; cortisol; renal function tests, such as blood urea nitrogen (BUN) and creatinine; electrolytes; glucose; liver function tests. \n\n B. Urine \n\n Routine urinalysis; urine pregnancy test. \n\n GnRH agonist will not be administered to any subject with significant clinical or laboratory abnormalities. The blood tests and urinalysis will be repeated 2 weeks after GnRH agonist administration to rule out any evidence of acute renal, hepatic or hematologic toxicity. \n\n Results of Pap smear performed within one year of the onset of treatment will be obtained. \n\n ", - "exclusion_criteria": ": \n\n The following conditions will constitute contraindications to treatment with hormonal therapy and will preclude a subject's participation in this protocol: \n\n current Axis I psychiatric diagnosis \n\n history consistent with endometriosis, \n\n diagnosis of ill-defined, obscure pelvic lesions, particularly, undiagnosed ovarian enlargement, \n\n hepatic disease as manifested by abnormal liver function tests, \n\n history of mammary carcinoma, \n\n history of pulmonary embolism or phlebothrombosis \n\n undiagnosed vaginal bleeding \n\n porphyria \n\n diabetes mellitus \n\n history of malignant melanoma \n\n cholecystitis or pancreatitis, \n\n cardiovascular or renal disease \n\n pregnancy \n\n Any woman meeting the Stages of Reproductive Aging Workshop Criteria (STRAW) for the perimenopause. Specifically, we will exclude any woman with an elevated plasma follicle stimulating hormone (FSH) level (>= 14 IU/L) and with menstrual cycle variability of > 7 days different from their normal cycle length. \n\n Subjects taking birth control pills will be excluded from the study. \n\n Subjects taking diuretics, prostaglandin inhibitors, or pyridoxine (putative treatments for MRMD) will similarly be excluded from the study \n\n Patients taking psychotropic agents (e.g., lithium carbonate, tricyclic antidepressants). \n\n All subjects will be required to use non-hormonal forms of birth control (e.g., barrier methods) to avoid pregnancy during this study.", - "brief_summary": "This study examines the effects of estrogen and progesterone on mood, the stress response, and brain function and behavior in women with premenstrual syndrome.~Previously this study has demonstrated leuprolide acetate (Lupron (Registered Trademark)) to be an effective treatment for PMS. The current purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in women with PMS.~PMS is a condition characterized by changes in mood and behavior that occur during the second phase of the normal menstrual cycle (luteal phase). This study will investigate possible hormonal causes of PMS by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. The results of these hormonal studies will be compared between women with PMS and healthy volunteers without PMS (see also protocol 92-M-0174).~At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies.", - "NCTID": "NCT00001259" - }, - { - "brief_title": "Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel", - "phase": "Phase 2", - "drugs": "['Skin test panel', 'Skin test panel']", - "drugs_list": [ - "Skin test panel", - "Skin test panel" - ], - "diseases": "['Premenstrual Syndrome']", - "diseases_list": [ - "Premenstrual Syndrome" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Person is over the age of 20 but not older than age 45. \n\n Person is willing to participate as evidenced by signing the written informed consent form. \n\n Suffers from known dominant severe symptom of breast swelling and tenderness (level 7-10 according to standard scale of PMS symptoms severity) \n\n Other severe symptoms of Premenstrual syndrome (based on WHO and ACOG criteria). This may include one or more of PMS symptoms with level 7-10 according to standard scale of PMS symptoms severity. \n\n At work, school, home, or in daily routine, at least one of the PMS symptoms caused reduction of productivity or inefficiency \n\n At least one of the PMS symptoms caused avoidance of or less participation in hobbies or social activities \n\n At least one of the PMS symptoms interfere with relationships with others: \n\n i. Timing of PMS symptom(s): during the 14 days prior to onset of menstrual flow (rather than spotting) and up to 5 days during the menstrual flow. \n\n ii. Pattern and length of PMS symptomatic period: minimum of 2 days, up to 14 days. \n\n iii. For PMS diagnosis two out of last three consecutive menstrual cycles were monitored by daily monitoring of symptoms. \n\n iv. Timing and length of asymptomatic phase: day 6 to at least day 10 of the menstrual cycle. \n\n v. Cyclicity - presentation of the 'off-on' phenomenon: there should be a clear shift from no PMS symptoms to PMS symptoms. \n\n vi. Reliable non hormonal contraception. \n\n ", - "exclusion_criteria": ": \n\n Pregnant or lactating woman \n\n Oral contraceptives during last three months, including hormonal IUD (trade name mirena). \n\n Serious health problems. \n\n Unexplained menstrual disorders. \n\n Treated by hormones (estrogen and progesterone). \n\n For healthy: Irregular or abnormal test results.", - "brief_summary": "The EVE-PMS technology is intended for determination of intolerance or sensitivity to sex hormones, among women suffering from severe PreMenstrual Syndrome (PMS).~The system includes skin testing panel for identification of hormones to which the patients might be sensitive. Tests are applied close to the ovulation period and the skin reaction is examined in 20 minutes, 48 hours and daily during the following month. Results of skin tests and patient's history will determine the value of EVE-PMS Skin-Test Panel as a diagnostic tool for severe PMS patients.", - "NCTID": "NCT00866437" - }, - { - "brief_title": "Dose-dependent Effects of VAC BNO 1095 on Cyclic Mastodynia and Premenstrual Syndrome", - "phase": "Phase 3", - "drugs": "['VAC BNO 1095 film coated tablets']", - "drugs_list": [ - "VAC BNO 1095 film coated tablets" - ], - "diseases": "['Cyclic Mastodynia', 'Premenstrual Syndrome']", - "diseases_list": [ - "Cyclic Mastodynia", - "Premenstrual Syndrome" - ], - "enrollment": "191.0", - "inclusion_criteria": "inclusion criteria: \n\n Females aged 18 to 45 who have signed an Informed Consent Form (ICF) at screening visit S-2 (screening visit -2) at the latest. \n\n Subject has a history of cyclic mastodynia and premenstrual syndrome \n\n Stable cycle duration of 25 to 35 days during the past 6 months before screening visit S-2. \n\n At screening visit S-2 subject is reporting at least one physical premenstrual syndrome symptom rated moderate or severe (lead symptom requiring treatment) and one psychic symptom for the late luteal phase of the preceding cycle, using the Calendar of Pre-menstrual Experiences (COPE) symptom list \n\n At screening visit S-2 subject is reporting symptoms of a total score of at least 15 in the late luteal phase of the preceding cycle, using the Calendar of Pre-menstrual Experiences (COPE) symptom list \n\n In both run-in cycles: \n\n Visual analog scale greater or equal 50 mm at least on one of the days of the late luteal phase \n\n Cyclic course of the mastodynia, i.e. visual analog scale in the mid follicular phase (maximum value of 5 daily recordings) is less than 75 % of the visual analog scale in the late luteal phase (maximum value of 5 daily recordings) \n\n Premenstrual syndrome sum score resulting from Calendar of Pre-menstrual Experiences (COPE) must be 20 or more in the late luteal phase (average of daily recordings documented on days -5 to -1) \n\n At least one physical premenstrual syndrome symptom must have been rated moderate or severe on at least one day of the late luteal phase, and one psychic symptom is present \n\n Premenstrual syndrome sum score resulting from Calendar of Pre-menstrual Experiences (COPE) must not exceed 10 at day 4 of the menstruation \n\n Premenstrual syndrome sum score resulting from Calendar of Pre-menstrual Experiences (COPE) must not exceed 8 in the mid follicular phase (average of daily recordings documented on days 6 to 10) \n\n Note: Late luteal phase is defined as days -5 to -1 (5 days prior to the onset of menses) while mid follicular phase is defined as days 6 to 10 after the onset of menses. \n\n ", - "exclusion_criteria": ": \n\n Pre- Menstrual Dysphoric Disorder \n\n Intake of any of the following medications before treatment start (visit S-2 up to visit V0) and within 6 months prior to visit S-2: \n\n Any treatment for mastodynia or premenstrual complaints \n\n Sexual hormones, combinations and inhibitors \n\n Pituitary hormones and their inhibitors \n\n Hypothalamic hormones \n\n Neuroleptics, antidepressants \n\n Serotonin-re-uptake-inhibitors \n\n Prolactin-inhibitors or prolactin stimulating preparations \n\n Non Steroidal Anti-Inflammatory Drugs (NSAIDs) or any other analgetics including antirheumatics \n\n Spironolactone \n\n Androgens \n\n Gonadotrophin inhibitors \n\n Diuretics \n\n Danazol \n\n Psychotropic agents", - "brief_summary": "Prospective, double-blind, placebo-controlled, 3 parallel groups, multi-center study in 180 patients with cyclic mastodynia with premenstrual syndrome. 225 patients will be screened to achieve 180 patients eligible for randomisation, 60 to each treatment group, of which 150 are expected to complete the study per protocol.~Study objectives:~Identification of the optimal dosage of VAC BNO 1095 (product name) film coated tablets for treatment of cyclic mastodynia and premenstrual syndrome.~To prove the efficacy of VAC BNO 1095 film coated tablets in the treatment of cyclic mastodynia.~Dose regimen:~Group 1: VAC BNO 1095 1x10 mg:~1 tablet of verum in the morning, 1 placebo tablet in the evening~Group 2: VAC BNO 1095 2x10 mg:~1 tablet of verum in the morning, 1 tablet of verum in the evening~Group 3: Placebo:~1 tablet placebo in the morning, 1 tablet placebo in the evening~The study consists of a 2-cycle run-in period, followed by 3 cycles of treatment. After first screening further visits are scheduled after the end of each of the first and second run-in cycle, and after the first, second and third treatment cycle, respectively.~Visits will be performed during the menses at day 3 (-1+3 days), i.e. 2 days after day 1 of menstruation number n, with exception of the first screening visit which can be performed at any time prior to the first run-in cycle. Subsequently the time between the first study visit and the onset of the first run-in cycle menses T shall be added to the overall study duration.~In case that the next menstruation does not commence as expected, the patient should contact her investigator immediately in order to schedule a new appointment, approximately on the actual day 3 of the menses.", - "NCTID": "NCT01309113" - }, - { - "brief_title": "LNG-IUS for Treatment of Dysmenorrhea", - "phase": "Phase 2", - "drugs": "['LNG-IUS', 'Combined oral contraceptives']", - "drugs_list": [ - "LNG-IUS", - "Combined oral contraceptives" - ], - "diseases": "['Adenomyosis']", - "diseases_list": [ - "Adenomyosis" - ], - "enrollment": "62.0", - "inclusion_criteria": "inclusion criteria: \n\n Women have dysmenorrhoea and/or chronic pelvic pain secondary to adenomyosis. \n\n Planning for birth spacing for at least 2 years. \n\n Patient aged between 20-45 years old. \n\n Ultrasonographic and Doppler examination suggestive of adenomyosis. \n\n Living in a nearby area to make follow-up reasonably possible. \n\n ", - "exclusion_criteria": ": \n\n Pregnancy \n\n Evidence of defective coagulation. \n\n History or evidence of malignancy. \n\n Hyperplasia in the endometrial biopsy. \n\n Incidental adnexal abnormality on ultrasound. \n\n Contraindications to COCs. \n\n Absolute contraindication of LNG-IUS insertion. \n\n Previous endometrial ablation or resection \n\n Uninvestigated postcoital bleeding \n\n Untreated abnormal cervical cytology", - "brief_summary": "Adenomyosis is a disease entity diagnosed when endometrial glands and stroma deep in the myometrium are associated with surrounding myometrial hypertrophy. The finding classically associated with adenomyosis is excessive uterine bleeding accompanied by worsening dysmenorrhea. The advent of endovaginal US has substantially improved the ability to diagnose adenomyosis. Different US features of adenomyosis have been reported, including uterine enlargement not explainable by the presence of leiomyomas, asymmetric thickening of the anterior or posterior myometrial wall, lack of contour abnormality or mass effect, heterogeneous poorly circumscribed areas within the myometrium, anechoic lacunae or cysts of varying sizes, and increased echotexture of the myometrium.~Transvaginal power Doppler application is useful in studying the vascular tree of adenomyosis and can aid clinicians in planning the most appropriate therapeutic strategy. The differential diagnosis using power Doppler sonography is based on vascular characteristics. Adenomyosis is characterized by a preserved vascular texture supply that results in dilated spiral arteries running perpendicular toward the myometrium into the endometrial surface. Leiomyomata exhibits a vascular tree that typically circumscribes the solid mass. 2D transvaginal power Doppler angiography should be used to improve diagnostic sensitivity and facilitate appropriate therapeutic intervention.~The levonorgestrel-releasing intrauterine system (IUS), Mirena, has been approved in Europe for contraception since 1990. Because of the suppressive effect of levonorgestrel on the endometrium, Mirena has also been proven to be effective for the management of menorrhagia and dysmenorrhea, and as a progestin component in postmenopausal hormone therapy. It was introduced in Taiwan in 1995 as an alternative therapy for idiopathic menorrhagia. Many cases of menorrhagia are caused by adenomyosis, and Mirena was, therefore, introduced for the treatment of adenomyosis in Taiwan.~The current study is designed to evaluate the best treatment modality for treatment of adenomyosis clinical by assessment of dysmenorrhea and or chronic pelvic pain by visual analogue scale and menstrual blood loss by menstrual diary, imaging by ultrasound and Doppler indices.", - "NCTID": "NCT01601366" - }, - { - "brief_title": "Norwegian Adenomyosis Study I", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Adenomyosis']", - "diseases_list": [ - "Adenomyosis" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Premenopausal women aged 30 - 50 years old \n\n scheduled for vaginal, abdominal or laparoscopic total hysterectomy \n\n one or more of the following clinical symptoms: bleeding disorders (menorrhagia, irregular bleeding, hypermenorrhoea), chronic pelvic pain, dysmenorrhoea, or dyspareunia \n\n junction zone definable \n\n ", - "exclusion_criteria": ": \n\n postmenopausal women, \n\n pregnancy \n\n gynecological cancer \n\n GnRH analog therapy or systemic hormone therapy in the last three months prior to hysterectomy \n\n junctional zone not identifiable", - "brief_summary": "Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of the uterus. It affects about 15-20% of the female population.~The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation (dysmenorrhea) and in addition chronic pelvic pain. Subfertility and infertility have been correlated with adenomyosis.~Parity, age and uterine abrasion increase the risk of adenomyosis. Hormonal factors such as local hyperestrogenism and elevated levels of prolactin have been identified, but autoimmune and mechanical factors are also hypothesized.~Regarding treatment, the most effective measure is hysterectomy. As this is a very drastic measure in younger women, levonogestrel-releasing intrauterine devices, Gonadotropin releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation have been tried, but studies are few in number, retrospective, and have small sample sizes.~Adenomyosis has so far not been subject to extensive research efforts. The pathogenesis of adenomyosis remains still unclear, there are not many satisfying treatment options and diagnostics include mostly magnetic resonance imaging (MRI) and histology.~The investigators designed a series of 3 studies with a broad approach in understanding adenomyosis. This is part 1.~NAPPED-1: comparison of 3D-transvaginal ultrasound with MRI and histology in the diagnostic of adenomyosis", - "NCTID": "NCT02201719" - }, - { - "brief_title": "Norwegian Adenomyosis Study III: Peristalsis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Adenomyosis', 'Infertility', 'Dysmenorrhea']", - "diseases_list": [ - "Adenomyosis", - "Infertility", - "Dysmenorrhea" - ], - "enrollment": "3.0", - "inclusion_criteria": "inclusion criteria: \n\n Premenopausal women aged 20-45 years having been diagnosed with adenomyosis earlier and have no other pathology of the uterus, regardless of clinical symptoms. \n\n ", - "exclusion_criteria": ": \n\n Postmenopausal women, \n\n Pregnant women, \n\n Gynaecological cancer, \n\n GnRH analog therapy or systemic hormone therapy in the last three months prior to hysterectomy, \n\n Endometriosis, \n\n Uterine fibroids", - "brief_summary": "Spontaneous contractions (peristalsis) of the non-pregnant uterus is widely investigated and the role of correct peristalsis is most important for correct sperm transport towards the fallopian tubes and implantation of the embryo, thus obtaining pregnancy. At the same time, an impaired uterine peristalsis is discussed to be the reason for lower pregnancy rates and may also account for heavy menstrual bleedings and menstrual pain.~In this study, the uterine peristalsis of women with adenomyosis will be investigated. This condition is associated to heavy menstrual bleeding, menstrual pain and infertility.", - "NCTID": "NCT02197936" - }, - { - "brief_title": "The Effect of Toremifene Treatment to the Magnetic Resonance Imaging (MRI) Findings in Premenstrual Mastalgia", - "phase": "Phase 3", - "drugs": "['toremifene', 'placebo']", - "drugs_list": [ - "toremifene", - "placebo" - ], - "diseases": "['Breast Pain']", - "diseases_list": [ - "Breast Pain" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Premenstrual mastalgia \n\n Age 20-45 years \n\n Reliable non-hormonal contraception \n\n ", - "exclusion_criteria": ": \n\n Pregnancy \n\n Breast cancer or uterine corpus cancer \n\n Unexplained menstrual disorders \n\n Serious health problems \n\n Hormonal contraception, including hormonal IUD trade name Mirena \n\n Oestrogen and/or progestin treatment \n\n Hysterectomy and/or oophorectomy or radiation therapy \n\n Artificial cardiac pacemaker/metallic prostheses", - "brief_summary": "The purpose of this study is to determine the effect of toremifene treatment to the MRI findings of the breast in women suffering from premenstrual mastalgia.", - "NCTID": "NCT00534846" - }, - { - "brief_title": "The Oral Contraceptive Pill for Premenstrual Worsening of Depression", - "phase": "", - "drugs": "['Drospirenone and ethinyl estradiol', 'Placebo']", - "drugs_list": [ - "Drospirenone and ethinyl estradiol", - "Placebo" - ], - "diseases": "['Premenstrual Syndrome', 'Depression']", - "diseases_list": [ - "Premenstrual Syndrome", - "Depression" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria \n\n Women who are non-smokers between the ages of 18-45 years (smokers 18-34 years); \n\n Regular menstrual cycles (26-34 days in length, predictable within 7 days) for the past 6 months; \n\n Determination that the antidepressant medication was initiated for the treatment of unipolar major depression, minor depression (depression, not otherwise specified), or dysthymia. Major depression and dysthymia will be evaluated through administration of the Mini-International Neuropsychiatric Interview (MINI). Minor depression will be evaluated by administration of the Structured Clinical Interview for Diagnosis-IV(SCID)10 section J.3. \n\n Use of an antidepressant for at least 3 months for treatment of a depressive disorder, with stable dose for at least 2 months. It is acceptable to be on more than one psychiatric medication as long as one of them is an antidepressant. \n\n Expected continued use of the same antidepressant at the same dose for the duration of the study; \n\n 30% increase of the mid-follicular phase Montgomery-\u00c5sberg Depression Rating Scale (MADRS) score to the late-luteal phase MADRS will be required for eligibility during the tracking phase of the study and will be assessed prospectively over 1 menstrual cycle. \n\n Normal pelvic exam and PAP smear in the past 12 months; \n\n Normal TSH at screen - if on thyroid medication, must be on a stable dose for 2 months or greater, and have a normal TSH at screen; \n\n Negative serum HCG at baseline, and negative urine HCG at visits 3 and 5; \n\n Normal potassium (K) levels at screen; \n\n Willingness to use barrier contraceptive methods during the study, if sexually active; \n\n Good general health. \n\n ", - "exclusion_criteria": ": \n\n Amenorrhea or irregular menstrual periods (defined as unable to predict within 7 days) during past 6 months \n\n Pregnancy or breastfeeding (serum HCG test administered at baseline study visit, and urine HCG at visits 3 and 5) \n\n Current cigarette smoking in women who are older than 34 years \n\n Presence of any of the following psychiatric and substance use disorders, based on administration of the MINI at the baseline study visit: \n\n Any history of mania or hypomania suggesting bipolar disorder Any lifetime history of a psychotic disorder \n\n Depression deemed by the physician investigator to be too severe to be treated in the study \n\n Use of benzodiazepines or antipsychotic to target premenstrual symptoms \n\n Luteal-phase dose adjustment of the antidepressant. Use of a hormone releasing IUD (intrauterine device) \n\n Use of an OCP or other systemic hormonal therapies (oral, transdermal or injection preparations of androgens, estrogens, or progestins) in the past 2 months; \n\n Any contraindication or previous adverse event to any OCP therapy; \n\n Current use of ketoconazole, rifampin, carbamazepine, topiramate, oxcarbazepine, modafinil, phenytoin, or phenobarbital (because of interaction with hormonal therapy). \n\n Current use of potassium-sparing agents, such as potassium-sparing diuretics (e.g., spironolactone), ACE inhibitors, angiotensin-II receptor antagonists, heparin, aldosterone antagonists, NSAIDS, potassium sparing diuretics or potassium-supplements (because of risk of developing arrhythmia with two potassium-elevating agents). \n\n Hepatic dysfunction, renal insufficiency, pulmonary, adrenal, or metabolic diseases (including elevated serum potassium levels, if known) that may put subject at risk when treated with study medication.", - "brief_summary": "To determine if augmentation with the oral-contraceptive pill containing drospirenone and ethinyl estradiol is more effective than placebo in the treatment of premenstrual breakthrough of depression.", - "NCTID": "NCT00633360" - }, - { - "brief_title": "Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder", - "phase": "Phase 4", - "drugs": "['Flutamide', 'Placebo']", - "drugs_list": [ - "Flutamide", - "Placebo" - ], - "diseases": "['Premenstrual Syndrome']", - "diseases_list": [ - "Premenstrual Syndrome" - ], - "enrollment": "115.0", - "inclusion_criteria": "inclusion criteria: \n\n Meets DSM-IV criteria for PMDD by history \n\n Regular menstrual cycles that are 25 to 35 days in length during the year prior to study entry \n\n Willing to use barrier methods of birth control during the study if sexually active \n\n If engaged in psychotherapy for at least 3 months before study entry, participation will be allowed if the intensity of psychotherapy remains the same during the study \n\n Normal PAP and physical exam, including pelvic exam, within the 1 year prior to study entry \n\n ", - "exclusion_criteria": ": \n\n Use of oral contraceptives or other exogenous hormone preparations within the 3 months prior to study entry \n\n Suicide attempt or severe suicidal ideation within the 2 years prior to study entry \n\n History of any psychotic disorder or bipolar disorder \n\n Substance abuse, except nicotine, within the 6 months prior to study entry \n\n Use of pharmacological treatment for PMDD symptoms (e.g., antidepressants, hormones, gonadotropin-releasing hormone agonists, anxiolytics, calcium, herbal preparations, diuretics) within the 3 months prior to study entry \n\n Daily use of psychotropic or anticonvulsant medications within the 3 months prior to study entry \n\n Use of sleeping pills more than once per week \n\n Consumption of more than 50 ounces of alcohol per week \n\n Pregnant or breastfeeding \n\n Hepatic, renal, autoimmune, or chronic inflammatory disease \n\n Seizure disorder \n\n Inability to read or follow instructions in English", - "brief_summary": "This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual dysphoric disorder.", - "NCTID": "NCT00611923" - }, - { - "brief_title": "Global Study of Women's Health", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Endometriosis', 'Infertility', 'Chronic Pelvic Pain', 'Tubal Ligation']", - "diseases_list": [ - "Endometriosis", - "Infertility", - "Chronic Pelvic Pain", - "Tubal Ligation" - ], - "enrollment": "1459.0", - "inclusion_criteria": "inclusion criteria: \n\n A patient who meets all of the following criteria is eligible for the study: \n\n Premenopausal female 18 to 45 years of age \n\n Attending for her first diagnostic laparoscopy or for laparoscopy for tubal sterilisation \n\n Has no previous history of endometriosis diagnosis through surgery \n\n ", - "exclusion_criteria": ": \n\n A patient who meets any of the following criteria is ineligible for the study: \n\n Already has a surgically-confirmed diagnosis of endometriosis \n\n Aged less than18 or greater than 45 \n\n Aged 18-45 but post-menopausal", - "brief_summary": "Endometriosis, a condition in which the lining of the uterus grows on nearby tissues, is a common condition that affects women of reproductive age worldwide. The diagnosis of endometriosis is usually made at surgery. The most common symptom is pelvic pain. This pain may occur at the same time as menstrual bleeding, at other times of the cycle, or during or after sexual intercourse. Previous studies reveal the diagnosis of endometriosis is often delayed between 8 and 12 years after the first symptoms. Women with chronic pelvic pain report a lower quality of life. No studies, however, have been conducted to assess whether women with endometriosis-related pelvic pain are affected differently than those with pelvic pain from other or no identifiable causes.~This large-scale study is designed to gather prospective epidemiological data on the impact of and risk factors for endometriosis across countries worldwide. A study of this scale and scope has never been performed; it is anticipated that the study will provide novel insights into the effects of the condition and associated symptoms on women s lives across different countries, as well as explore differences in the effects of various potential risk factors.~This is an international study conducted at more than 20 sites worldwide and coordinated by Oxford University in the United Kingdom. At the National Institutes of Health, 250 premenopausal women between 18 and 45 years of age who are having their first diagnostic laparoscopy or laparoscopy for tubal sterilization will participate. None will have had a prior diagnosis of endometriosis through surgery. Women will be informed about the study when their laparoscopy is scheduled.~Procedures~Patient completion of an online questionnaire before scheduled surgery. The following will be assessed by the questionnaire:~Quality of life~General gynecologic and medical history~Family history~General information~Use of health care services~Risk factors~Surgeon completion of questionnaire about surgical findings.~Follow-up: Women who consent will be contacted every 1 2 years.", - "NCTID": "NCT00849173" - }, - { - "brief_title": "Tranexamic Acid (TA) vs Combined Oral Contraceptive (COCP) Pilot Study", - "phase": "", - "drugs": "['Oral tranexamic acid', 'Oral Contraceptive Pills']", - "drugs_list": [ - "Oral tranexamic acid", - "Oral Contraceptive Pills" - ], - "diseases": "['Menorrhagia']", - "diseases_list": [ - "Menorrhagia" - ], - "enrollment": "17.0", - "inclusion_criteria": "inclusion criteria: \n\n Menstruating females with menorrhagia or menometrorrhagia referred to hematology or gynecology clinics at Texas Childrens Hospital. Menorrhagia is defined as regular periods with heavy menstrual bleeding with a PBAC score greater than 100; menometrorrhagia is heavy vaginal bleeding occurring at irregular intervals. \n\n PBAC Score greater than 100 for 2 consecutive cycles \n\n Pelvic ultrasound that excludes pelvic pathology that can cause menorrhagia within 12 months prior to study participation. \n\n Normal external genitalia examination within 6 months prior to study participation. \n\n Normal thyroid stimulating hormone (TSH) in the last 6 months prior to study participation. \n\n Negative urine or serum pregnancy test within 4 weeks prior to study participation. \n\n ", - "exclusion_criteria": ": \n\n Presence of intra uterine device. \n\n Presence of a diagnosed bleeding disorder based on the standard work-up including complete blood count (CBC), prothrombin time, partial thromboplastin time, fibrinogen, von Willebrand panel and platelet function analysis (PFA-100) or platelet aggregation. \n\n Intake of medications with increased risk of bleeding \n\n Taking herbal products. \n\n Sexually active status. \n\n Body weight less than 40 kg.", - "brief_summary": "Menorrhagia, considered a public health challenge and reported by 5 to 10% of adult women, is encountered even more frequently in adolescents. Surveys of school students in the United States (US) and Europe reported menorrhagia in 37% to 55% of adolescent females. Medical management of adolescent menorrhagia includes various formulations of hormonal therapy and the antifibrinolytic agent epsilon aminocaproic acid. Oral tranexamic acid (TA), a more potent antifibrinolytic agent used as standard therapy for menorrhagia in adult women and in adolescent women in Europe and Canada, was not previously available in the US. Subsequent to US FDA approval in November 2009 of a novel oral TA formulation to treat cyclic heavy menstrual bleeding in adult women, this medication is currently included in the treatment armamentarium for adult menorrhagia. There is currently no preliminary data available in the US about the clinical use of oral TA in an exclusive adolescent population with menorrhagia. Oral contraceptive pills (OCP) are considered standard therapy in the management of menorrhagia in teen-aged women. Oral TA has been shown to be more efficacious than progesterone-only hormonal therapy for menorrhagia in adult women. However, there is no data available comparing the efficacy of oral TA and combined OCP (COCP) in adult women or in adolescents with menorrhagia.~The study hypothesis is that, in adolescent menorrhagia, oral TA will have comparable efficacy in reducing menstrual blood loss (MBL) and improving quality of life (QOL) when compared to the commonly prescribed COCP.~This hypothesis was tested by comparing the efficacy of these two medications, in a prospective randomized crossover trial in post-menarchal young girls with menorrhagia.", - "NCTID": "NCT01428713" - }, - { - "brief_title": "Norplant and Irregular Bleeding/Spotting", - "phase": "Phase 4", - "drugs": "['doxycycline']", - "drugs_list": [ - "doxycycline" - ], - "diseases": "['Endometrial Bleeding', 'Periodontal Disease']", - "diseases_list": [ - "Endometrial Bleeding", - "Periodontal Disease" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria \n\n Regular menstrual periods for the last 2 cycles \n\n Currently not using hormonal contraceptives, including oral contraceptives, patch, ring, or Norplant in 2 months prior to study entry, or Depo-Provera in 12 months prior to study entry \n\n Currently not using tetracycline-class antibiotics \n\n Normal Pap smear \n\n ", - "exclusion_criteria": " \n\n Pregnancy or breastfeeding within 2 months of study entry \n\n Chronic migraine headaches \n\n Uncontrolled high blood pressure \n\n Untreated sexually transmitted diseases \n\n Alcoholism or drug abuse within 12 months of study entry \n\n Insulin dependent diabetes \n\n Liver, kidney, or gallbladder disease \n\n Participation in another clinical trial within 30 days of study entry \n\n History of cancer \n\n History of blood clots, strokes, or heart disease", - "brief_summary": "Irregular or prolonged menstrual bleeding and/or spotting are common side effects in patients using progestin-only hormonal contraception such as levonorgestrel implants (Norplant). Doxycycline, a drug approved by the Food and Drug Administration (FDA) to treat gum disease, may reduce the occurrence of uterine bleeding and spotting in women who use Norplant. This study will evaluate the effects of doxycycline on uterine bleeding/spotting in women using Norplant.", - "NCTID": "NCT00064766" - }, - { - "brief_title": "Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA)", - "phase": "Phase 4", - "drugs": "['Tranexamic acid', 'Mefenamic acid', 'Placebo', 'Mirena (Levonorgestrel IUS, BAY86-5028)']", - "drugs_list": [ - "Tranexamic acid", - "Mefenamic acid", - "Placebo", - "Mirena (Levonorgestrel IUS", - "BAY86-5028)" - ], - "diseases": "['Uterine Hemorrhage']", - "diseases_list": [ - "Uterine Hemorrhage" - ], - "enrollment": "187.0", - "inclusion_criteria": "inclusion criteria: \n\n Signed and dated informed consent \n\n Healthy female subjects requesting contraception \n\n Age: 18 - 45 years inclusive \n\n Successful interval insertion of MIRENA \n\n History of regular cyclic menstrual periods \n\n Normal or clinically insignificant cervical smear not requiring further follow up \n\n ", - "exclusion_criteria": ": \n\n Pregnancy or lactation \n\n Climacteric symptoms prior to the screening visit \n\n Known or suspected clinically significant ovarian cysts, endometrial polyps, fibroids, or other genital organ pathology, that, in the opinion of the investigator, may interfere with the assessment of the bleeding profile during the study \n\n Undiagnosed abnormal genital bleeding \n\n Current or history of thrombembolic disease, or established risk factors for venous thromboembolism \n\n Current migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia, or exceptionally severe headaches \n\n Hypersensitivity to any ingredient of the investigational medicinal products or the non-investigational medicinal product \n\n Daily or frequent use of a nonsteroidal anti-inflammatory drug (NSAIDs) for any condition \n\n Not willing to use nonsteroidal anti-inflammatory drug (NSAIDs) medication as pain medication during the double blind treatment period", - "brief_summary": "The purpose of the study is to investigate if the study drugs (tranexamic acid or mefenamic acid) can control irregular bleeding during the first 3 months of using Mirena. The study drugs tested are tested against placebo (dummy medication not containing any active drug). Treatment period is followed by a one-month period when study drugs are not taken but Mirena use is continued.", - "NCTID": "NCT01295294" - }, - { - "brief_title": "Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea", - "phase": "Phase 2; Phase 3", - "drugs": "['DRSP 3 mg/EE 20 \u00b5g (13 cycles)', 'DRSP 3 mg/EE 30 \u00b5g (6 cycles)']", - "drugs_list": [ - "DRSP 3 mg/EE 20 \u00b5g (13 cycles)", - "DRSP 3 mg/EE 30 \u00b5g (6 cycles)" - ], - "diseases": "['Dysmenorrhea']", - "diseases_list": [ - "Dysmenorrhea" - ], - "enrollment": "420.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients aged 20 years or older at obtaining informed consent \n\n Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before the final enrollment \n\n Patients having a total dysmenorrheal score of at least 3 points in twice of the latest menstruation before the final enrollment \n\n ", - "exclusion_criteria": ": \n\n Patients with ovarian chocolate cysts \n\n Patients with fibroid needed to be treated \n\n Patients with estrogen-dependent tumors and patients with cervical cancer or suspected cervical cancer \n\n Patients with undiagnosed abnormal vaginal bleeding \n\n Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease, or coronary artery disease or a history of those diseases \n\n Patients aged 35 years or older who smoke at least 15 cigarettes per day \n\n Patients with migraine accompanied by prodromata \n\n Patients with pulmonary hypertension or valvular heart disease \n\n Patients who are regularly taking nutritional products that contain St. John's Wort \n\n Patients who underwent surgical treatment for endometriosis within 2 months prior to screening \n\n Patients who may need to regularly use analgesics for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)", - "brief_summary": "The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety", - "NCTID": "NCT00461305" - }, - { - "brief_title": "Study About Patients Using Copper Intrauterine Device", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Copper Intrauterine Device Induced Bleeding']", - "diseases_list": [ - "Copper Intrauterine Device Induced Bleeding" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Regularly menstruating women before CIUD insertion. \n\n Age between 18 and 35 years. \n\n Hormonal treatment has not been taken at least two months before the study. \n\n Non steroidal anti-inflammatory drugs has not been taken 24 hours before the examination. \n\n ", - "exclusion_criteria": ": \n\n Pregnancy. \n\n The presence of pelvic pathology as ovarian cysts, pelvic endometriosis, endometrial polyps or fibrosis. \n\n Present or past history of pelvic inflammatory disease. \n\n Patients on hormonal treatment in the last two months before the study. \n\n Patients on non steroidal anti-inflammatory drugs last 24 hours before the examination.", - "brief_summary": "THE AIM OF THE this study is to assess the hemodynamic changes of uterine artery in patients with CIUD induced bleeding by using transvaginal color Doppler indices (uterine artery resistance index and pulsatility index) to prove the relationship between these changes and bleeding in these patient .", - "NCTID": "NCT01541241" - }, - { - "brief_title": "A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC", - "phase": "", - "drugs": "['transdermal estradiol', 'naproxen', 'oral placebo']", - "drugs_list": [ - "transdermal estradiol", - "naproxen", - "oral placebo" - ], - "diseases": "['Contraception', 'Bleeding']", - "diseases_list": [ - "Contraception", - "Bleeding" - ], - "enrollment": "129.0", - "inclusion_criteria": "inclusion criteria: \n\n Must be of reproductive age from 18 to 45 years \n\n Must be choosing LNG-IUC for contraception \n\n Must be English-speaking \n\n Be willing to avoid additional use of exogenous hormones, such as oral contraceptives, for the duration of the study \n\n Be willing to avoid additional use of nonsteroidal antiinflammatory drugs, such as ibuprofen or aspirin for the duration of the study \n\n Be willing to comply with the study protocol, keep the bleeding diary and comply with follow-up visits and telephone interviews as scheduled \n\n Be willing and able to provide informed consent \n\n ", - "exclusion_criteria": ": \n\n Known or suspected pregnancy \n\n Contraindication to estrogen use, such as presence or history of: \n\n venous thromboembolism \n\n Arterial thrombosis \n\n Thrombophilia disorders, or known family history of \n\n Hypertension \n\n Migraine headaches with aura or focal neurologic involvement, or any migraine over age 35 years \n\n Recent or planned future major surgery which will result in prolonged immobilization during the study period \n\n Presence or history of severe hepatic disease or liver tumors \n\n Known or suspected estrogen-dependent neoplasm \n\n Vaginal bleeding of unknown etiology \n\n Any cigarette smoking and age over 35 years \n\n Contraindications to nonsteroidal anti-inflammatory use, such as presence or history of: \n\n Gastrointestinal ulcer disease \n\n Renal insufficiency or failure \n\n Aspirin-induced asthma or hypersensitivity reaction \n\n Systemic lupus erythematosus (SLE) and mixed connective tissue disorders \n\n Use of anticoagulants \n\n Cardiovascular disease \n\n Use of medications that alter estrogen metabolism, i.e. rifampin, certain anti-seizure medications \n\n Regular use of an NSAID \n\n Current diagnosis of menorrhagia, metrorrhagia, symptomatic uterine fibroids, or endometrial polyp \n\n Hypersensitivity or allergy to any of the components of the estradiol patch \n\n Use of injectable contraception within 6 months of the start of the study medication \n\n Delivery or abortion in the previous 4 weeks \n\n Prior use of LNG-IUD \n\n Any condition, that in the opinion of the investigator, would contraindicate study participation", - "brief_summary": "We hypothesize that the addition of oral naproxen or transdermal estradiol will decrease the number of days of unscheduled bleeding experienced by first-time users of the levonorgestrel intrauterine system (LNG-IUC) during the first 12 weeks of use compared to an oral placebo. The objective of this study is to compare the total number of days of bleeding experienced by first time users of the LNG-IUC randomized to oral naproxen or estradiol patch compared to those randomized to placebo for the first 12 weeks of use. We will enroll women initiating LNG-IUC to one of 3 groups, transdermal estrogen, oral naproxen or oral placebo. We will enroll a total of 114 women, 38 in each group. Women will keep bleeding diaries for 16 weeks which will be used to calculate the total number of bleeding or spotting days. Statistical analysis will be performed to evaluate if there is less bleeding among the treatment arms then the placebo arm.", - "NCTID": "NCT00789802" - }, - { - "brief_title": "Investigation of Tibolone and Escitalopram in Perimenopausal Depression", - "phase": "Phase 4", - "drugs": "['Tibolone', 'Escitalopram', 'Natvia']", - "drugs_list": [ - "Tibolone", - "Escitalopram", - "Natvia" - ], - "diseases": "['Perimenopausal Depression']", - "diseases_list": [ - "Perimenopausal Depression" - ], - "enrollment": "2.0", - "inclusion_criteria": "inclusion criteria: \n\n Females who are currently physically well and between 45 and 55 years of age \n\n Current DSM-IV diagnosis of depression disorder \n\n Able to give informed consent \n\n Perimenopausal as determined by symptom profile on the Stages of Reproductive Aging Workshop and gonadal hormonal profile \n\n ", - "exclusion_criteria": ": \n\n Known abnormalities in the hypothalamic-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, active or past history of a venous thromboembolic event, breast pathology, undiagnosed vaginal bleeding or abnormal Pap smear results in the previous 2 years. \n\n Patients with any significant unstable medical illness such as epilepsy and diabetes or known active cardiac, renal or liver disease; or the presence of illness causing immobilisation. \n\n Patients receiving treatment for depression including antidepressant medications, electroconvulsive therapy (ECT) / Transcranial Magnetic Stimulation (TMS), formal psychotherapy or counselling, within the past 6 months \n\n Patients experiencing severe melancholia, neurovegetative symptoms or current suicidality necessitating acute hospitalisation or intensive psychiatric treatment. \n\n Patients with psychotic symptoms or past history of severe mental illness including schizophrenia, and bipolar disorder. \n\n Use of any form of estrogen, progestin or androgen as hormonal therapy, or antiandrogen including tibolone or use of phytoestrogen supplements as powder or tablet \n\n Pregnancy / Lactation \n\n Smoking cigarettes and other nicotine products. \n\n illicit drug use and more than 3 standard drinks per day", - "brief_summary": "Many perimenopausal women experience severe mood symptoms for the first time in their life, with no past psychiatric history. The importance of clearly identifying and treating a disorder that is increasingly referred to as perimenopausal depression is highlighted by the wide-reaching impact this can have on the lives of women suffering from it. This is not a minor or short term mood disturbance; it is a severe depressive illness, needing effective and early treatment. Relationships, employment, participation in social roles and individual well-being can all be disrupted by the combination of the mood, hormonal and physical changes associated with the transition to menopause. The term perimenopausal depression denotes the onset of depression coinciding with the onset of reproductive hormone changes.~Many women with this type of depression experience serious and long term debilitating symptoms. Treatment commonly draws on traditional approaches for the management of major depression including the use of antidepressants such as selective serotonin reuptake inhibitors (SSRIs) as the first line response. However, standard treatment of perimenopausal depression using antidepressants has only shown small improvements at best and at worst, is associated with severe side effects. Some SSRIs have been shown to be less effective in postmenopausal women compared to child bearing age women. Hormone treatments directly targeting the fluctuating reproductive hormone systems (in particular estrogen) through the administration of compounds such as tibolone, have significant potential as a better overall treatment.~To date, there is still a lack of clear clinical evidence about the best approach for the biological treatment of women with perimenopausal depression. The project we now propose to conduct is a 12-week randomised controlled trial (RCT) of 2.5 mg/day tibolone compared to 10mg/day of escitalopram (an SSRI that has targeted serotonin action)compared to placebo to discover the best treatment approach for a hitherto understudied depression that affects a large proportion of women in their late forties and fifties.", - "NCTID": "NCT01368068" - }, - { - "brief_title": "The Treatment of Insomnia in Symptomatic Peri- and Postmenopausal Women", - "phase": "", - "drugs": "['Eszopiclone', 'Placebo']", - "drugs_list": [ - "Eszopiclone", - "Placebo" - ], - "diseases": "['Menopause', 'Insomnia']", - "diseases_list": [ - "Menopause", - "Insomnia" - ], - "enrollment": "67.0", - "inclusion_criteria": "inclusion criteria: \n\n Women 40+ years old. \n\n Subject must have any of the following perimenopausal or postmenopausal signs and symptoms as defined by the Stages of Reproductive Aging Workshop (STRAW): \n\n Early Menopausal Transition (Stage -2): Variable cycle length >7 days different from normal. \n\n Late Menopausal Transition (Stage -1) : > 2 skipped cycles and an interval of amenorrhea > 60 days. \n\n Post Menopause (Stage +1): Amenorrhea for at least 12 months. \n\n Surgical Post Menopause \n\n Hysterectomized women with one or both ovaries preserved will be eligible if FSH levels > 20 IU/L. \n\n If on hormonal therapy, history of menstrual-cycle abnormalities consistent with any of 2a-2e above indicating peri-/postmenopausal status prior to initiation of hormonal therapy. \n\n One or both the following insomnia symptoms for \u00b3 3 nights per week for at least one month prior to study enrollment: \n\n Difficulty initiating sleep (\u00b3 30 minutes) \n\n Difficulty maintaining sleep (wake time after sleep onset \u00b3 30 minutes) \n\n Daytime function or well-being is impaired as a result of insomnia. \n\n Mild depression and/or anxiety at screening visit defined as: \n\n Mild Depressive symptoms defined by Montgomery-\u00c5sberg Depression Rating Scale-MADRS (MADRS) \u00b3 10 administered at screening visit, or \n\n Mild Anxiety symptoms defined by Beck Anxiety Inventory (BAI) \u00b3 10 administered at screening visit. \n\n May have (but not required) hot flushes \n\n May have (but not required) developed insomnia after discontinuation of hormonal therapy. \n\n If subject is on an antidepressant, they must have stable doses for at least 2 months. \n\n If subject is on hormonal therapy, dose must be stable for at least 2 months. \n\n General Good Health \n\n ", - "exclusion_criteria": ": \n\n According to M.I.N.I (Mini International Neuropsychiatric Interview), subject meets current or past criteria for past 3 months: \n\n Major Depression \n\n Dysthymia \n\n Panic disorder \n\n PTSD (Post-Traumatic Stress Disorder) \n\n According to M.I.N.I, subject has no evidence of current suicidal ideation, homicidal ideation, or psychotic symptoms at screening visit. \n\n Suicide attempt in the past 5 years. \n\n According to M.I.N.I, subject meets criteria for substance use disorder diagnosis within the past 5 years. \n\n Subject has current or recent use (in the past month and used > 25% of time) of hypnotic agents. \n\n Subject is on an antidepressant or hormone therapy in past 2 months. (Unless they are taking currently and have had a stable dose for \u2265 2 months). \n\n Subject has: \n\n Unstable medical abnormality \n\n Unstable chronic disease. \n\n History of significant cardiac, renal, or hepatic disease, or seizure disorder. \n\n Regular use of any disallowed medication (Including; Clarithromycin, Itraconazole, Ketoconazole, Nefazodone, Nelfinavir, Olanzapine, Rifampin, Ritonavir, Troleandomycin) currently or in the past month. \n\n Subject has a disorder or history of a condition (e.g., mal-absorption, gastrointestinal surgery) that may interfere with drug absorption, distribution, metabolism, or excretion. \n\n Subject has a been previously diagnosed sleep apnea, restless leg syndrome (RLS), or periodic leg movement syndrome (PLMS), or has any condition that may affect sleep (e.g., chronic pain, urinary incontinence, etc.). \n\n Subject reports consumption of more than two alcoholic beverages daily, 14 or more alcoholic beverages weekly, or five or more alcoholic beverages on any given day during the past month. \n\n Currently pregnant or breastfeeding \n\n Subject is a rotating or third/night shift worker. \n\n Subject often travels across multiple time zones. \n\n Subject is currently enrolled in another clinical trial, subject has participated in any investigational drug study within 30 days prior to screening, or plans to participate in another investigational drug study during participation in this study.", - "brief_summary": "To examine the change in sleep patterns and mood symptoms in response to eszopiclone (Lunesta) using a double-blind placebo-controlled cross-over study design in perimenopausal and postmenopausal women who experience insomnia, mild depression and/or anxiety.", - "NCTID": "NCT00374192" - }, - { - "brief_title": "An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060)", - "phase": "Phase 2", - "drugs": "['Etonogestrel-releasing IUS', 'Etonogestrel-releasing IUS', 'Etonogestrel-releasing IUS', 'Multiload-cu 375\u00ae']", - "drugs_list": [ - "Etonogestrel-releasing IUS", - "Etonogestrel-releasing IUS", - "Etonogestrel-releasing IUS", - "Multiload-cu 375\u00ae" - ], - "diseases": "['Contraception']", - "diseases_list": [ - "Contraception" - ], - "enrollment": "84.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy female subjects in need for contraception will be selected to participate in the trial; \n\n Each subject must be >=18 to <=40 years of age at screening and in need for contraception; \n\n Each subject must have given birth to at least one child (gestational age >=28 weeks); \n\n Each subject must have a uterus with a measured length between 6.0 and 9.0 cm (extremes included) from external os to fundus uteri. \n\n ", - "exclusion_criteria": ": \n\n A subject must not be pregnant or suspected to be pregnant; \n\n A subject must not have had an ectopic pregnancy in the past or must not have a history or presence of predisposing factors for this condition such as salpingitis, endometritis or pelvic peritonitis; \n\n A subject must not have a history or presence of any malignancy; \n\n A subject must not have a history or presence of premalignant disease of the uterus or cervix, including endometrial hyperplasia, or (other) sex-steroid sensitive premalignancies; \n\n A subject must not have an active venous thromboembolic disorder (e.g. deep vein thrombosis, pulmonary embolism); \n\n A subject must not have a history or presence of severe hepatic disease with AST and/or ALT levels of >=3 times the upper normal limit; \n\n A subject must not have congenital or acquired malformations or distortions of the uterus or cervix; \n\n A subject must not have large or multiple uterine fibromyomata, or a smaller uterine fibromyoma which may interfere with the insertion of the MIUS/IUD according to the investigator; \n\n A subject must not have vaginal bleeding of undiagnosed etiology; \n\n A subject must not have dysmenorrhea interfering with daily activities or menorrhagia", - "brief_summary": "This is a phase 2, randomized, active-controlled, parallel-group, multicenter, single-blind trial of three different doses of etonogestrel releasing medicated intrauterine systems (ENG-MIUS) in healthy parous women in need for contraception.~The primary trial objective is to explore safety and acceptability of three doses of an ENG-releasing medicated intrauterine system (ENG-MIUS) as compared to Multiload-cu 375\u00ae.", - "NCTID": "NCT00967746" - }, - { - "brief_title": "The Role of Vitamin D in Menopause: Relationship to Menopausal Symptoms in Body Composition", - "phase": "Phase 1", - "drugs": "['Vitamin D', 'Placebo']", - "drugs_list": [ - "Vitamin D", - "Placebo" - ], - "diseases": "['Menopause, Premature', 'Hot Flushes', 'Obesity', 'Vitamin D Deficiency']", - "diseases_list": [ - "Menopause", - "Premature", - "Hot Flushes", - "Obesity", - "Vitamin D Deficiency" - ], - "enrollment": "23.0", - "inclusion_criteria": "inclusion criteria: \n\n Women in late menopausal transition or early menopause \n\n Age 40-55 \n\n BMI >25 kg/m2 \n\n Suffer from menopausal symptoms \n\n Change in previously regular cycles consisting of at least \u22652 skipped cycles and an interval of amenorrhea (\u226560 days) in the last year \n\n Negative pregnancy test \n\n Vitamin D insufficiency (<30 ng/ml) \n\n Weight stability (+/- 5%) for 3 months \n\n ", - "exclusion_criteria": ": \n\n No period for >12 months \n\n Hormone use (i.e. menopausal hormone therapy, oral contraceptive, other hormonal medications) in last 3 months \n\n History of hysterectomy more than 11 months ago \n\n Abnormal screening blood tests (i.e. elevated serum calcium level, elevated creatinine) \n\n History of medical conditions where Vitamin D supplementation is not indicated (i.e. chronic renal insufficiency, elevated calcium, sarcoidosis or other granulomatous disease, lymphoma, or tuberculosis \n\n History of osteoporosis or osteoporosis on baseline DXA (expect less than 4% of screened population)84 \n\n Vitamin D deficiency (<10 ng/ml) as we felt it was unethical to withhold supplementation for 12 months in severe deficiency (according to our KPNW survey, this will exclude <2% of population) \n\n Consuming more than 400 IU of Vitamin D supplementation daily (we felt such doses taken outside of the study design could confound results) \n\n Current smoker (within the last year) \n\n Taking medications that affect body weight \n\n Prior bariatric surgery \n\n Taking medications or herbal supplements that affect mood (i.e. antidepressants) or menopausal symptoms (i.e. herbal meds) or sleep \n\n Weighing more than 400 pounds (cannot fit on DEXA scan) \n\n Not fluent in English or cognitively impaired", - "brief_summary": "Specific Aim 1: To compare effects of Vitamin D supplementation to usual care on symptoms in women transitioning to early postmenopause and determine the associated effect size in order to conduct a power analysis for a future RCT. Hypothesis: Vitamin D insufficient women in early postmenopause who are randomized to supplementation, titrated to achieve sufficiency for 2 months, will have fewer symptoms including hot flashes, mood, and musculoskeletal complaints than women randomized to usual care.~Specific Aim 2: To compare effects of Vitamin D supplementation to usual care on body composition (by dual-energy x-ray absorptiometry [DXA] and by weight, BMI, waist to hip ratio) in overweight/obese women transitioning to early postmenopause and determine the associated effect size for a power analysis for a future RCT. Hypothesis: Vitamin D insufficient women in the menopausal transition randomized to supplementation, titrated to achieve sufficiency for 9 months, will improve DXA body composition (less total body and abdominal fat), compared to women in usual care, who will have increased body weight, including total and abdominal fat.~Specific Aim 3: To estimate the proportion of overweight/obese middle-aged women who achieve sufficiency by 1 month versus 2 or more months and to determine if achieving sufficiency by 1 month varies by baseline characteristics. Hypothesis: About 80% of participants will achieve sufficient Vitamin D level by 1 month. Those who need more than 1 month for sufficiency will have lower baseline levels and higher initial BMI.", - "NCTID": "NCT01141972" - }, - { - "brief_title": "Evaluation of the Ovarian Reserve in Infertile Patients With Endometriosis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Endometriosis']", - "diseases_list": [ - "Endometriosis" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18-35 years of age. Written and signed informed consent by the patient to participate in the study. Patients with regular menses, both ovaries, serum TSH within normal range, body mass index (BMI) <30 kg/m2 with normal sperm analysis of the husband. \n\n ", - "exclusion_criteria": ": \n\n Patients with previous endocrine disorders. Cases in which the cause for infertility was other than endometriosis (except for patients with tubal obstruction, in the control group). \n\n Patient with previous surgery for endometriosis.", - "brief_summary": "Comparison between Ovarian reserve markers in patients with minimal/mild endometriosis and patients with tubal factor infertility", - "NCTID": "NCT01941017" - }, - { - "brief_title": "China Clinical Trial for Therapeutic MR-HIFU Ablation of Uterine Fibroids", - "phase": "", - "drugs": "['MR-HIFU uterine fibroid treatment']", - "drugs_list": [ - "MR-HIFU uterine fibroid treatment" - ], - "diseases": "['Uterine Fibroids']", - "diseases_list": [ - "Uterine Fibroids" - ], - "enrollment": "107.0", - "inclusion_criteria": "inclusion criteria: \n\n Women, age between 18 and 55 years \n\n Weight < 140 kg \n\n Pre- or peri-menopausal \n\n Uterine size < 24 weeks \n\n Cervical cell assessment by Pap smear/Thin-prep Cytologic Test (TCT): Normal, Low Grade Squamous Intraepithelial Lesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells of Uncertain Significance (ASCUS) subtypes of cervical tissue \n\n Fibroids selected for treatment meeting the following criteria: \n\n Total planned ablation volume of all fibroids should not exceed 250 ml, and \n\n No more than 5 fibroids should be planned for ablation, and \n\n Dominant fibroid (diameter) is greater than or equal to 3 cm, and \n\n Fibroids which are completely non-enhancing under Magnetic Resonance (MR) contrast agent should not be treated as the identification of treated volume becomes ambiguous \n\n Highly perfused or brighter than myometrium in T2-weighted MRI (according to the T2 contrast obtained using the Philips MR-HIFU protocol) fibroids should not be treated \n\n MR-HIFU device accessibility to fibroids such that at least 50% of the total fibroid volume can be treated \n\n Willing and able to attend all study visits \n\n ", - "exclusion_criteria": ": \n\n Other pelvic disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis) \n\n Desire for future pregnancy \n\n Significant systemic disease, even if controlled \n\n Positive pregnancy test \n\n Hematocrit < 25% \n\n Extensive scarring along anterior lower abdominal wall (> 50% of area) \n\n Surgical clips in the direct path of the HIFU beam \n\n MRI contraindicated \n\n MRI contrast agent contraindicated \n\n Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurements are not feasible) \n\n Calcifications around or throughout uterine tissues \n\n Communication barrier \n\n Suspected malignancy", - "brief_summary": "The purpose of this study is to demonstrate safety and effectiveness of the Philips Sonalleve Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) for treatment of uterine fibroids in a Chinese population.", - "NCTID": "NCT01588899" - }, - { - "brief_title": "Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation", - "phase": "", - "drugs": "['Femring\u00ae', 'DepoProvera \u00ae']", - "drugs_list": [ - "Femring\u00ae", - "DepoProvera \u00ae" - ], - "diseases": "['Metrorrhagia']", - "diseases_list": [ - "Metrorrhagia" - ], - "enrollment": "71.0", - "inclusion_criteria": "inclusion criteria: \n\n Women age 18 or older who are initiating Depo-Provera for contraception \n\n English or Spanish-speaking \n\n Have a negative urine pregnancy test \n\n ", - "exclusion_criteria": ": \n\n Contraindications to either Depo-Provera or Femring (estrogen vaginal ring) \n\n Have used Depo-Provera or Mirena in the prior 6 months \n\n Have had an induced abortion, spontaneous abortion, or birth in prior 8 weeks", - "brief_summary": "Many women choose Depo-Provera for birth control because it is easy to use and very effective. However, a significant number of Depo-Provera users experience irregular bleeding during the first 90 days. Many users discontinue after their first injection due to irregular bleeding. This study will evaluate the effect of using an estrogen vaginal ring during the first 90 days of Depo-Provera use to see if it is acceptable to women and whether it decreases irregular bleeding during the first 90 days of use and increases continuation to a second injection.", - "NCTID": "NCT00563576" - }, - { - "brief_title": "To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)", - "phase": "Phase 3", - "drugs": "['Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'Ortho Tri Cyclen Lo']", - "drugs_list": [ - "Estradiol valerate", - "Dienogest (Natazia", - "Qlaira", - "BAY86-5027)", - "Ortho Tri Cyclen Lo" - ], - "diseases": "['Contraception']", - "diseases_list": [ - "Contraception" - ], - "enrollment": "409.0", - "inclusion_criteria": "inclusion criteria: \n\n Signed and dated informed consent \n\n Age between 18 and 50 years (inclusive), smokers maximum age of 35 years (inclusive) at Visit 1 \n\n Otherwise healthy female subjects requesting contraception and currently using a LNG, NGM, or norethindrone/norethindrone acetate containing OC in a 21-day regimen and suffering from at least moderate pelvic pain, headache or both defined by an average of the highest 3 values of >/=35 mm on a VAS during cycle days 22-28 (35 mm VAS is the expected standard deviation of the population VAS reduction) \n\n Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the last 6 months before screening) Women with atypical squamous cell of undetermined significance (ASCUS) can be included if they have a negative human papilloma virus (HPV) test result. The laboratory will perform an HPV test if the Pap smear result is ASCUS. \n\n Able to tolerate ibuprofen and willing to use only ibuprofen supplied by the investigator \n\n ", - "exclusion_criteria": ": \n\n Pregnancy or lactation (less than three cycles since delivery, abortion, or lactation before start of treatment) \n\n Body mass index (BMI) >32 kg/m2 \n\n Hypersensitivity to any of the study drug ingredients \n\n Individuals not willing to consume pork and beef products. Women may be included if they are willing to take the capsules \n\n Safety relevant laboratory values, provided by the central laboratory, outside inclusion range before start of treatment \n\n Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication (such as but not limited to duodenal ulcers, gastritis, gastrectomy or gastric resection surgery, or renal compromise) \n\n Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results \n\n Any disease or condition that may worsen under hormonal treatment \n\n Undiagnosed abnormal genital bleeding \n\n Abuse of alcohol, drugs, or medicines (eg, laxatives) \n\n Other contraceptive methods \n\n Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results \n\n Simultaneous participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator \n\n Major surgery scheduled for the study period \n\n Subject is a dependent person, eg: a family member or member of the Investigator's staff \n\n Inability to cooperate with the study procedures for any reason, including language comprehension, psychiatric illness, inability to get to the study site", - "brief_summary": "The objective of the study is to compare the oral contraceptive (OC) SH T00658ID over Ortho Tri-Cyclen Lo administered for 13 cycles to healthy female volunteers between 18 and 50 years of age who request oral contraceptive protection. Subjects on a levonorgestrel (LNG), norgestimate (NGM), norethindrone or norethindrone acetate containing oral contraceptive in a 21-day regimen suffering from hormone withdrawal-associated symptoms such as pelvic pain or headache or both, and willing to continue OC use but to switch to SH T00658ID or Ortho Tri-Cyclen Lo.", - "NCTID": "NCT00754065" - }, - { - "brief_title": "Targeted Vessel Ablation of Type 3 Uterine Fibroids With Magnetic Resonance Guided High Intensity Focused Ultrasound", - "phase": "", - "drugs": "['Magnetic Resonance guided High Intensity Focused Ultrasound']", - "drugs_list": [ - "Magnetic Resonance guided High Intensity Focused Ultrasound" - ], - "diseases": "['Uterine Fibroid']", - "diseases_list": [ - "Uterine Fibroid" - ], - "enrollment": "6.0", - "inclusion_criteria": "inclusion criteria: \n\n Able to give informed consent; \n\n A type 3 uterine fibroid; \n\n Sufficient physical condition to undergo deep sedation; \n\n Waist circumference that allows positioning on the HIFU table top inside the MR bore. \n\n ", - "exclusion_criteria": ": \n\n Contra-indication for MRI scanning according to the hospital guidelines; \n\n Contra-indication to injection of gadolinium-based contrast agent, including known prior allergic reaction to any contrast agent, and renal failure (GFR <30 mL/min/1.73 m2); \n\n Surgical clips or considerable scar tissue in the HIFU beam path; \n\n A total of more than ten fibroids; \n\n Post- or peri-menopausal status; \n\n Fibroid size >10 cm in diameter; \n\n Patient has an active pelvic infection; \n\n Patient has an undiagnosed pelvic mass outside the uterus; \n\n Patient who is not able to tolerate the required stationary prone position during treatment.", - "brief_summary": "So-called type 1 and 2 uterine fibroids are well treatable with Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU). The other type, type 3 fibroids, however, are known for their high perfusion and poor treatment outcome after MR-HIFU. This study proposes a new strategy to treat type 3 fibroids with MR-HIFU. Very precise, small, high-power sonications (heating points) will be used to occlude (part of) the feeding vessels of the fibroid. This deminishes the negative effect of the high perfusion and is hypothesized to transform a type 3 fibroid into a type 2 or possibly even a type 1 fibroid. Consequently, the bulk volume of the fibroid can be treated using the standard approach.", - "NCTID": "NCT02633254" - }, - { - "brief_title": "CKD-828 Primary Hypertension Trial(Dose-selection)", - "phase": "Phase 2", - "drugs": "['S-Amlodipine, Telmisartan', 'S-Amlodipine', 'Telmisartan', 'Placebo']", - "drugs_list": [ - "S-Amlodipine", - "Telmisartan", - "S-Amlodipine", - "Telmisartan", - "Placebo" - ], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "430.0", - "inclusion_criteria": "inclusion criteria: \n\n age 18 years or older \n\n stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure >=95 and <=115 mmHg \n\n ability to provide written informed consent \n\n ", - "exclusion_criteria": ": \n\n severe hypertension defined as: a mean seated cuff diastolic blood pressure >=116mmHg or a mean seated cuff systolic blood pressure >=200mmHg \n\n known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma) \n\n has severe heart disease(Heart failure NYHA functional class 3, 4), unstable angina or myocardial infarction, arrhythmia within the past three months \n\n has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months \n\n Type I Diabets Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) > 8% \n\n known severe or malignant retinopathy \n\n hepatic or renal dysfunction as defined by the following laboratory parameters: AST/ALT > UNL X 2, serum creatinine > UNL X 1.5 \n\n acute or chronic inflammatory status need to treatment \n\n need to additional antihypertensive drugs during the study \n\n need to concomitant medications known to affect blood pressure during the study \n\n history of angioedema related to ACE inhibitors or Angiotensin II Receptor Blockers \n\n known hypersensitivity related to either study drug \n\n history of drug or alcohol dependency \n\n any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bypass, active inflammatory bowel syndrome within 12 months prior to screening, currently active gatritis, ulcers of gastrointetinal/rectal bleeding, impaired pancreatic fuction such as pancreatitis,obstructions of the urinary tract or difficulty in voiding) \n\n cannot swallow investigational products \n\n administration of other study drugs within 4 weeks prior to randomization \n\n premenopausal women(last menstration < 1year) not using adequte contraception, pregnant or breast-feeding \n\n history of malignancy including leukemia and lymphoma within the past 5 years \n\n in investigator's judgment", - "brief_summary": "The aim of this trial is to determine the best dose combination of S-Amlodipine and Telmisartan as compared to monotherapy by assessing the blood pressure lowering effects of a once daily regimen of various combinations of S-Amlodipine and Telmisartan, compared to their monotherapy components and placebo, in patients with stage I or II essential hypertension(a mean seated cuff diastolic blood pressure >=95 and <=115 mmHg).", - "NCTID": "NCT01128322" - }, - { - "brief_title": "Radial Extracorporeal Shock Wave Therapy on Chronic Low Back Pain: a Prospective Controlled Study", - "phase": "", - "drugs": "['Radial Extracorporeal Shock Wave Therapy 2000 impulses', 'Radial Extracorporeal Shock Wave Therapy 4000 impulses']", - "drugs_list": [ - "Radial Extracorporeal Shock Wave Therapy 2000 impulses", - "Radial Extracorporeal Shock Wave Therapy 4000 impulses" - ], - "diseases": "['Low Back Pain']", - "diseases_list": [ - "Low Back Pain" - ], - "enrollment": "26.0", - "inclusion_criteria": "inclusion criteria: \n\n Symptom of low back pain during last 4 weeks \n\n Low back pain history for more than 3 months \n\n ", - "exclusion_criteria": ": \n\n Have lower limbs radiating pain beyond knee joints \n\n Spinal tumorous or infectious disease, fracture, ankylosing spondylitis, cauda equina syndrome or other severe spinal diseases \n\n Spinal surgical history \n\n Severe heart, lung, liver, kidney disease or high blood pressure \n\n With cardiac pacemaker \n\n Coagulopathy or thrombosis \n\n Have ESW therapy or pharmaceutical treatment for low back pain during last 1 months \n\n Mental illnesses or none cooperation \n\n Pregnancy", - "brief_summary": "The aim of this prospective study is to explore the pain-alleviating effect of low-energy extracorporeal shock wave therapy(ESWT) in patients with chronic low back pain.", - "NCTID": "NCT01928784" - } - ], - "1": [ - { - "brief_title": "Uterine Leiomyoma Treatment With Radiofrequency Ablation", - "phase": "", - "drugs": "['Radiofrequency ablation of fibroids']", - "drugs_list": [ - "Radiofrequency ablation of fibroids" - ], - "diseases": "['Uterine Fibroids']", - "diseases_list": [ - "Uterine Fibroids" - ], - "enrollment": "26.0", - "inclusion_criteria": "inclusion criteria \n\n Premenopausal (at least 1 menstrual period in last 3 months) \n\n Age >21years \n\n Fibroids are associated with heavy bleeding, pelvic pressure or discomfort, urinary or bowel symptoms, or dyspareunia \n\n Desires surgical management of fibroids \n\n Uterus \u226416 weeks in size \n\n All fibroids \u2264 10cm in maximum diameter by ultrasound or MRI assessment within the last year. \n\n Total number of fibroids \u22646 by ultrasound or MRI assessment within the last year. (For this study Fibroids will be leiomyomas > 2cm) \n\n Had a Pap smear within the last 3 years with appropriate follow-up and treatment for cellular abnormalities \n\n Endometrial biopsy indicates no hyperplasia or cancer (biopsy only required if age >45 years and has anovulatory heavy bleeding) \n\n Able to tolerate laparoscopic surgery \n\n Able to give informed consent \n\n ", - "exclusion_criteria": " \n\n Planned treatment for infertility \n\n Pedunculated fibroid with thin stalk (total stalk length is <25% maximum diameter of fibroid) \n\n Intracavitary (FIGO Type 0) fibroid \n\n Symptomatic fibroids are only FIGO Type 1 (submucosal with \u2265 50% intracavitary) \n\n Planned concomitant surgical procedure in addition to treatment of uterine fibroids \n\n Use of Essure or any other metallic, implantable device within pelvis \n\n Pregnancy \n\n Pelvic infection with the last 3 months \n\n History of pelvic malignancy and/or pelvic radiation \n\n Known or high suspicion for dense pelvic adhesions \n\n Fibroids treated by myomectomy, uterine artery embolism, radio-frequency ablation, MRI Guided focused ultrasound, or cryomyolysis within the last 3 months", - "brief_summary": "The ULTRA study is a single-arm trial of 100 premenopausal women with symptomatic uterine fibroids who undergo treatment with the Acessa device. The Acessa device is a new FDA approved minimally invasive treatment for uterine fibroids that uses radiofrequency energy to destroy fibroid tissue. The fibroids then shrink and symptoms are significantly improved. The radiofrequency energy is delivered to the fibroids during an outpatient surgical procedure. There is minimal blood loss and pain and women return to the usual activities 5-9 days after the Acessa procedure.~The investigators will evaluate changes in fibroid-related symptoms from before the Acessa treatment to 3, 6, 12, 18, 24, 30, and 36 months after Acessa treatment. The investigators will also assess operative outcomes including procedure duration, complications, blood loss, post-operative pain, and the time to return to usual activities. The investigators will determine long-term efficacy of Acessa by evaluating the rate of re-treatment for symptomatic fibroids after the Acessa procedure.~Study participants will be recruited at 5 sites within the UC Fibroid Network: UC Davis, UC Irvine, UC Los Angeles, UC San Diego, and UC San Francisco. UC San Francisco will serve as the Coordinating Center for the trial with oversight of all scientific and administrative aspects of the study. All study data will be stored securely in a HIPAA compliant, secure database monitored by the UC San Francisco Coordinating Center. A data safety and monitoring board will oversee participant safety and protection.", - "NCTID": "NCT01840124" - }, - { - "brief_title": "Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914", - "phase": "Phase 2", - "drugs": "['ulipristal acetate 20 mg', 'ulipristal acetate 10 mg', 'placebo']", - "drugs_list": [ - "ulipristal acetate 20 mg", - "ulipristal acetate 10 mg", - "placebo" - ], - "diseases": "['Leiomyoma']", - "diseases_list": [ - "Leiomyoma" - ], - "enrollment": "72.0", - "inclusion_criteria": "inclusion criteria: \n\n Female gender-to evaluate effects in the target population for clinical trials. \n\n History of uterine leiomyoma causing symptoms of bleeding, pressure, or pain, as defined by the American College of Obstetrics and Gynecology (ACOG) practice bulletin: \n\n Excessive uterine bleeding will be evidenced by either of the following-profuse bleeding with flooding or clots or repetitive periods lasting for more than 8 days; or anemia due to acute or chronic blood loss; \n\n OR \n\n Pelvic discomfort caused by leiomyomata, either acute and severe or chronic lower abdominal or low back pressure or bladder pressure with urinary frequency not due to urinary tract infection. \n\n Uterine leiomyoma(ta) of at least 2 cm size. \n\n In good health. Chronic medication use is acceptable except for glucocorticoid use. Other chronic medication use may be acceptable at the discretion of the research team. Interval use of over-the-counter drugs is acceptable but must be recorded. \n\n Menstrual cycles of 24 - 35 days. \n\n Hemoglobin greater than 10 g/dL (for those wishing surgery); iron may be administered to improve red blood cell counts. \n\n Willing and able to comply with study requirements. \n\n Age 25 to 50. \n\n Using mechanical (condoms, diaphragms) sterilization or abstinence methods of contraception for the duration of the study. \n\n Negative urine pregnancy test. \n\n Body mass index (BMI) less than or equal to 33, if a surgical candidate or less than or equal to 35, if not a surgical candidate. \n\n Creatinine less than 1.3 mg/dL. \n\n Liver function tests within 130% of upper limit. \n\n If interested in hysterectomy, no desire for fertility. \n\n ", - "exclusion_criteria": ": \n\n Significant abnormalities in the history, physical or laboratory examination. \n\n Pregnancy. \n\n Lactation. \n\n Use of oral, injectable or inhaled glucocorticoids or megestrol within the last year. \n\n Unexplained vaginal bleeding. \n\n History of malignancy within the past 5 years. \n\n Use of estrogen or progesterone-containing compounds, such as oral contraceptives and hormone replacement therapy, within 8 weeks of study entry, including transdermal, injectable, vaginal and oral preparations. \n\n Use of agents known to induce hepatic P450 enzymes; use of imidazoles. \n\n Current use of Gonadotropin-releasing hormone (GnRH) analogs or other compounds that affect menstrual cyclicity. \n\n Follicle stimulating hormone (FSH) greater than 20 IU/mL. \n\n Untreated cervical dysplasia. \n\n Need for interval use of narcotics. \n\n Abnormal adnexal/ovarian mass. \n\n Use of herbal medication having estrogenic or antiestrogenic effects within the past 3 months. \n\n Contradiction to anesthesia, for women planning surgery. \n\n Genetic causes of leiomyomata. \n\n Previous participation in the study. \n\n Known recent rapid growth of fibroids, defined as a doubling in size in six months.", - "brief_summary": "This study will evaluate whether the experimental drug ulipristal acetate can shrink uterine fibroids in pre-menopausal women.", - "NCTID": "NCT00290251" - }, - { - "brief_title": "Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids", - "phase": "", - "drugs": "['MR Guided Focused Ultrasound', 'Placebo MR Guided Focused Ultrasound']", - "drugs_list": [ - "MR Guided Focused Ultrasound", - "Placebo MR Guided Focused Ultrasound" - ], - "diseases": "['Uterine Fibroids']", - "diseases_list": [ - "Uterine Fibroids" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Age>18 years \n\n Premenopausal \n\n Symptomatic fibroids \n\n Fibroids accessible for focused ultrasound treatment \n\n ", - "exclusion_criteria": ": \n\n Desires future fertility \n\n Current pregnancy \n\n Hematocrit <30% \n\n Emergency room visit in last 3 months for fibroid symptoms \n\n History of venous thromboembolism \n\n Fibroids that are: >10cm, non-enhancing with contrast \n\n Adenomyosis \n\n Contraindications to undergoing MRI \n\n Unexplained menstrual irregularity", - "brief_summary": "This is a pilot randomized, blinded, placebo-controlled trial of a noninvasive, FDA approved treatment for uterine fibroids called MR Guided Focused Ultrasound (MRgFUS). Our hypothesis is that MRgFUS provides superior relief of fibroid symptoms compared with the placebo, a sham MRgFUS treatment. The investigators will recruit 20 premenopausal women with symptomatic uterine fibroids to participate in the trial. Participants will be randomly assigned in a 2:1 ratio to the active treatment arm (MRgFUS) versus the sham MRgFUS treatment. Participants will remain blinded to their group assignment for 3 months. After 3 months, participants will be told their treatment group and those assigned to the sham group will be offered complimentary MRgFUS if they desire it. Women will be excluded if they are inappropriate candidates for a 3 month delay in fibroid treatment, such as those with significant anemia. The investigators will assess the change from baseline to 1 and 3 months after treatment in fibroid symptoms, quality of life, fibroid volume measured by MRI, and hematocrit.", - "NCTID": "NCT01377519" - }, - { - "brief_title": "Conventional Infertility Treatment vs. Fast Track to IVF", - "phase": "", - "drugs": "['intrauterine insemination', 'infertility']", - "drugs_list": [ - "intrauterine insemination", - "infertility" - ], - "diseases": "['Infertility']", - "diseases_list": [ - "Infertility" - ], - "enrollment": "503.0", - "inclusion_criteria": "inclusion criteria: \n\n Female partner age 21 up to 40th birthday, at the time of recruitment. Infertility is defined as failure to conceive a recognized pregnancy after one year (or 12 menstrual cycles) of unprotected intercourse. \n\n Male partner has a normal semen analysis with a sperm concentration of >15 million total motile sperm, >1% normal forms by strict criteria, or >5 million total motile sperm on IUI prep. \n\n Female patient has at least one ovary and at least one ipsilateral patent fallopian tube confirmed by HSG or laparoscopy; pelvic pathology amenable to operative laparoscopy (pelvis restored to functional). The open tube cannot have had a previous ectopic (tubal) pregnancy and the closed tube cannot be a hydrosalpinx (a tube that is blocked at the end and filled with fluid), unless a tubal ligation has been performed at the junction of the uterus and fallopian tube. \n\n Patients with surgically corrected stages I and II endometriosis will be included. \n\n Normal uterine cavity demonstrated by HSG, Sonohysterogram (SHG), or hysteroscopy; pathologies of uterine cavity amenable to operative hysteroscopy (cavity restored to normal and demonstrated by post operative study). \n\n Anovulatory patients who did not conceive after a minimum of three ovulatory cycles with any medications, not including gonadotropin therapy. Anovulatory patients unable to achieve ovulation at dosages up to 150 mg of clomiphene or standard dosages of other ovulation inducing medications (i.e. bromocriptine). Hypoestrogenic hypothalamic amenorrhea patients will qualify immediately for inclusion, prior to any gonadotropin therapy. \n\n Normal ovarian reserve demonstrated in all patients i.e., cycle day 3 FSH/E2 values of <15 mIU/mL and <100 pg/mL, respectively. Normal TSH and prolactin. \n\n Female body mass index \u2264 38. \n\n ", - "exclusion_criteria": ": \n\n Previous tubal reconstructive surgery in which the pelvis was not restored to functional. \n\n Unilateral or bilateral hydrosalpinx (a tube that is blocked at the end and filled with fluid) that has not had a tubal ligation performed at the junction of the uterus and fallopian tubes. \n\n A laparoscopy that demonstrated pelvic adhesions or endometriosis for which the pelvis could not be restored to normal by surgery or endometriosis was not ablated or excised. All patients with stages III and IV endometriosis. \n\n One or more prior ectopic pregnancies in which one or both tubes were rendered nonfunctional; two or more ectopic pregnancies, even if tubes are patent. \n\n Severe male factor (i.e.; semen analysis with a sperm concentration of <15 million total motile sperm, <1% normal forms by strict criteria, or <5 million total motile sperm on IUI prep). Couples using donor semen will be excluded. \n\n Previous treatment with IUI or IVF. Previous treatment of normal ovulation patients with gonadotropins. \n\n Inadequate ovarian reserve demonstrating FSH >15 mIU/mL or estradiol > 100 pg/mL. \n\n Patients requiring gamete intrafallopian tube transfer (GIFT), zygote intrafallopian tube transfer (ZIFT), or tubal embryo transfer (TET). \n\n Female body mass index > 38.", - "brief_summary": "The purpose of this randomized prospective clinical trial is to determine whether an infertility treatment that moves quickly to In Vitro Fertilization (IVF) is more cost effective than the usual treatment strategy which includes various combinations of infertility drugs and intrauterine insemination (IUI) prior to utilizing In Vitro Fertilization.", - "NCTID": "NCT00260091" - }, - { - "brief_title": "Pilot of Letrozole for Uterine Myomas", - "phase": "Phase 4", - "drugs": "['Letrozole', 'Placebo']", - "drugs_list": [ - "Letrozole", - "Placebo" - ], - "diseases": "['Leiomyoma', 'Uterine Fibroids']", - "diseases_list": [ - "Leiomyoma", - "Uterine Fibroids" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria: \n\n \u226521 years old \n\n Premenopausal (at least one menses in last 3 months) \n\n Symptomatic fibroids (fibroids visualized on ultrasound or MRI and heavy uterine bleeding, pelvic pressure or discomfort, urinary or bowel abnormalities, dyspareunia) \n\n Fibroids that are \u22644 in total number or Fibroids that are \u22647 in total number if all fibroids are less than 4cm (40 mm) each \n\n Fibroids that are \u22647cm in maximum diameter, on screening imaging, if \u22644 fibroids in total number(fibroid is defined as any mass with radiographic characteristics of fibroid >2cm) \n\n Up to date in Pap smear screening and surveillance \n\n Endometrial biopsy (required if age>45 years with irregular bleeding) does not indicate premalignant or malignant cells \n\n Agree to use non-hormonal barrier method of contraception during study period if at risk for pregnancy \n\n Has primary care provider or gynecologist \n\n Agrees not to start new medications/treatments for fibroids during the study \n\n Able to give informed consent \n\n ", - "exclusion_criteria": ": \n\n Fibroids treated by surgery, radiologic procedure, or GnRH agonist or antagonist in the last 3 months \n\n Any submucosal fibroid \u22652cm that is >50% in uterine cavity (FIGO Type 0 or Type 1 fibroids) amenable to hysteroscopic resection \n\n Use of exogenous estrogen and/or progestin in the last month. (for 3 month long-acting depoprovera injection, no use in last 3 months) \n\n Pregnant, lactating, or planning to become pregnant in the next 6 months \n\n Hematocrit <27% or visit to emergency room or hospitalization for fibroid symptoms in the last 3 months (cannot be safely randomized to a placebo) \n\n History of osteopenia or osteoporosis \n\n History of hyperlipidemia \n\n Current liver or kidney disease \n\n Unable or unwilling to attend 4 study visits \n\n Pelvic imaging concerning for gynecologic cancer or cancer of the genitourinary or gastrointestinal system \n\n Does not have primary care provider or gynecologist", - "brief_summary": "PLUM evaluates the drug letrozole as a treatment for uterine fibroids. This study is a randomized, blinded, placebo-controlled trial of oral letrozole among premenopausal women with symptomatic uterine fibroids. Participants will be randomly assigned in a 1:1 ratio to either oral letrozole 2.5mg/day for 6 months (Group A) or intermittent dosing with letrozole 2.5mg/day and an identical placebo capsule (Group B).", - "NCTID": "NCT02470741" - }, - { - "brief_title": "ENDmetriosis and Reserve Ovarienne", - "phase": "", - "drugs": "['blood samples']", - "drugs_list": [ - "blood samples" - ], - "diseases": "['Deep Endometriosis Stage III', 'Deep Endometriosis Stage IV']", - "diseases_list": [ - "Deep Endometriosis Stage III", - "Deep Endometriosis Stage IV" - ], - "enrollment": "118.0", - "inclusion_criteria": "inclusion criteria: \n\n female patient between 18 and 38 years \n\n endometriosis stage III or IV in the AFSr classification \n\n laparoscopy included deep endometriosis procedures (adhesiolysis, ureterolysis, cystectomy, resection of bowel, urinary or deep peritoneal endometriosis) \n\n written informed consent \n\n ", - "exclusion_criteria": ": \n\n previous adnexectomy or adnexectomy during surgery", - "brief_summary": "Endometriosis is the ectopic implantation of endometrial glands and stroma, and can be ovarian and peritoneal (superficial or deep). There are 4 stages in endometriosis according to severity, and the stage is established on the basis of intra-operative observations. The AFSr classification is currently most used (I-IV,minimal, mild, moderate, severe). Most associated with endometriosis are subfertility and pelvic pain.~In the surgical management of deep endometriosis, the issue of fertility is pivotal. There is a higher rate of infertility in a population of women with endometriosis as compared to the general population, even though the mechanisms are not yet elucidated. Patients with deep endometriosis can be referred to the surgeon for subfertility, but even when they are referred for chronic pain, future fertility considerations are taken into account in the planning of the surgery, as the patients are often young.~It is now well documented that ovarian cystectomy is deleterious with regards to the ovarian reserve, and more so in endometriomas than in any other type of benign cysts. The ovarian reserve is the functional potential of the ovaries, reflecting the quantity and quality of remaining follicles. Studies have also relied greatly on the measure of serum anti-mullerian hormone (AMH) to evaluate the effect of cystectomy on ovarian reserve, as AMH is currently the most reliable marker to assess ovarian reserve. A significant difference was found between AMH before and following cystectomy in several studies. The deleterious effect of deep endometriosis surgery which comprises a wide dissection and adhesiolysis of the pelvis in many cases, even when no cystectomy has been performed, is therefore not entirely ruled out. To the best of our knowledge, there are no studies on the effect of deep endometriosis surgery, apart from ovarian surgery, on ovarian reserve.~Our center is very active in the laparoscopic surgical treatment of deep endometriosis, with more than 200 cases every year. The objective of this trial is to assess the effect of deep endometriosis surgery on the ovarian reserve, whether a cystectomy is performed or not, by measuring serum AMH before and after surgery, at 6 months and 1 year post-operatively.", - "NCTID": "NCT02400684" - }, - { - "brief_title": "Efficacy and Safety of SH T00660AA in Treatment of Endometriosis", - "phase": "Phase 3", - "drugs": "['Visanne (BAY86-5258, SH T00660AA)', 'Placebo']", - "drugs_list": [ - "Visanne (BAY86-5258", - "SH T00660AA)", - "Placebo" - ], - "diseases": "['Endometriosis']", - "diseases_list": [ - "Endometriosis" - ], - "enrollment": "198.0", - "inclusion_criteria": "inclusion criteria: \n\n Female patients with endometriosis-associated pelvic pain \n\n ", - "exclusion_criteria": ": \n\n Pregnant or lactating women \n\n history or suspicion of hormone dependent tumor \n\n therapy resistant endometriosis \n\n need for primary surgical treatment \n\n any other conditions which forbid the participation.", - "brief_summary": "The purpose of this study is to demonstrate safety and efficacy of SH T00660AA compared to placebo in the treatment of endometriosis", - "NCTID": "NCT00225199" - }, - { - "brief_title": "Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients", - "phase": "Phase 4", - "drugs": "['observation natural cycle', 'Agonist GnRH; estradiol Valerate; progesterone']", - "drugs_list": [ - "observation natural cycle", - "Agonist GnRH; estradiol Valerate; progesterone" - ], - "diseases": "['Infertility']", - "diseases_list": [ - "Infertility" - ], - "enrollment": "70.0", - "inclusion_criteria": "inclusion criteria: \n\n infertile females with preserved gonadal function \n\n ages 18 - 44 years old included \n\n first oocyte donation cycle \n\n ", - "exclusion_criteria": ": \n\n BMI: > 28 \n\n recurrent miscarriages (3 or more) \n\n recurrent of implantation failure \n\n severe male factor \n\n important miomas \n\n > 44 years old \n\n Problems with the drugs used in the study", - "brief_summary": "The purpose of this study is to compare the natural cycle (without any medication) with the well-established artificial cycle in an egg donation program.", - "NCTID": "NCT01353846" - }, - { - "brief_title": "Laparoscopic Surgical Management of Endometriosis on Fertility", - "phase": "", - "drugs": "['retrospective study']", - "drugs_list": [ - "retrospective study" - ], - "diseases": "['Endometriosis']", - "diseases_list": [ - "Endometriosis" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients over 18 years \n\n Patients operated by laparoscopy for endometriosis in our department between 2006 and 2014. \n\n ", - "exclusion_criteria": ": \n\n Patients under 18 years", - "brief_summary": "The aim of the investigators study is to know the results of the endometriosis surgery and particularly to highlight a benefit of this surgery on fertility.", - "NCTID": "NCT02481739" - }, - { - "brief_title": "Biologic Predictors of Leiomyoma Treatment Outcomes", - "phase": "", - "drugs": "['DNA analysis', 'Hormonal analysis']", - "drugs_list": [ - "DNA analysis", - "Hormonal analysis" - ], - "diseases": "['Uterine Leiomyomas', 'Fibroids', 'Uterine Fibroids', 'Myomas']", - "diseases_list": [ - "Uterine Leiomyomas", - "Fibroids", - "Uterine Fibroids", - "Myomas" - ], - "enrollment": "38.0", - "inclusion_criteria": "inclusion criteria: \n\n Able and willing to give consent \n\n Age 18 or older \n\n Presence of known uterine leiomyoma \n\n ", - "exclusion_criteria": ": \n\n 1. Suspected malignancy", - "brief_summary": "The purpose of this study is to search for the hereditary (genetic) causes of uterine fibroids. Some women with uterine fibroids may have one or more genes that make them more likely to develop uterine fibroids. We are trying to identify these genes to better understand how and why uterine fibroids develop and to design better treatment options for women with uterine fibroids. This information may also help us to understand and treat other problems that may be caused by these genes.", - "NCTID": "NCT01936493" - } - ], - "2": [ - { - "brief_title": "Histopathological Diagnosis of Adenomyosis", - "phase": "", - "drugs": "['hysteroscopic endo-myometrial biopsy', 'ultrasound']", - "drugs_list": [ - "hysteroscopic endo-myometrial biopsy", - "ultrasound" - ], - "diseases": "['Adenomyosis']", - "diseases_list": [ - "Adenomyosis" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n females complaining of pelvic congestion: dysmenorrhea, dyspareunia, chronic pelvic pain, menorrhagia, metrorrhagia \n\n ", - "exclusion_criteria": ": \n\n refusal of the patient to get enrolled in the study", - "brief_summary": "The purpose of this study is to develop and evaluate a hysteroscopic endo-myometrial biopsy for diagnosing adenomyosis.", - "NCTID": "NCT02340533" - }, - { - "brief_title": "Somatic Stem Cells in Endometriosis", - "phase": "", - "drugs": "['genetic analysis']", - "drugs_list": [ - "genetic analysis" - ], - "diseases": "['Endometriosis']", - "diseases_list": [ - "Endometriosis" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n inclusion criteria for patients with endometriosis: \n\n Female patients with ovarian endometriosis, peritoneal and recto-vaginal. \n\n Aged between 20 and 40. \n\n Signing of informed consent for collection and storage of biological samples. \n\n ", - "exclusion_criteria": ": \n\n Contraindications for endometrial biopsy. \n\n Failure to sign informed consent for collection and storage of biological samples.", - "brief_summary": "Human endometrium is a very dynamic tissue characterized by cyclical process of proliferation, differentiation and cellular shedding as part of each menstrual cycle. This issue suggests the presence of somatic stem cells. Endometriosis is characterized by presence of endometrium outside the uterine cavity. The existence of a somatic stem cell population in endometrium could explain the incorrect proliferation of these cells, which would lead to formation of endometriotic foci.", - "NCTID": "NCT01412138" - }, - { - "brief_title": "Quality of Life in Endometriosis - a Case Control Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Endometriosis', 'Quality of Life', 'Pain', 'Sexuality', 'Anxiety', 'Depression', 'Infertility']", - "diseases_list": [ - "Endometriosis", - "Quality of Life", - "Pain", - "Sexuality", - "Anxiety", - "Depression", - "Infertility" - ], - "enrollment": "1267.0", - "inclusion_criteria": "inclusion criteria: \n\n female >18 years fluent German \n\n Cases: diagnosis of endometriosis Control 1: no endometriosis, no chronic pain Control 2: no endometriosis, chronic abdominal/pelvic pain \n\n ", - "exclusion_criteria": ": \n\n male (Except for partner questionnaires) \n\n <18years \n\n not fluent in German", - "brief_summary": "Endometriosis, one of the most common diseases of women during their reproductive period., may present a chronic disabling disease with major impact on women's life. Therapeutic options are limited and recurrence of disease symptoms is frequent.~The current study investigates the quality of life and several risk factors for the development of endometriosis as well as satisfaction with medical support in a minimum of 600 women with different stages of endometriosis and the same number of control women matched for age (\u00b1 3 years) and nationality. To evaluate specific features of endometriosis-associated pain a second group of 100 women with chronic abdominal/pelvic pain not related to endometriosis is investigated. Recruitment takes place in different university clinics, and districts hospitals in Switzerland, Germany. And Austria. Control women i.e. women without any evidence for endometriosis presenting for annual routine gynaecological controls are collected at the same places.~A composition of different internationally validated questionnaires as well as specific questions on dealing with endometriosis is used to collect information on the quality of life and potential risk factors for endometriosis. Questions on sexuality and partnership are also distributed to women's partners. All diagnosis of endometriosis and classification of ASRM (American Society for Reproductive Medicine) disease stages are based on woman's medical charts.", - "NCTID": "NCT02511626" - } - ] - }, - { - "patient_id": "sigir-201511", - "patient": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", - "0": [ - { - "brief_title": "Maternal Hypothyroidism in Pregnancy", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Hypothyroidism']", - "diseases_list": [ - "Hypothyroidism" - ], - "enrollment": "72.0", - "inclusion_criteria": "inclusion criteria: \n\n TSH value >98th centile in early pregnancy \n\n ", - "exclusion_criteria": ": \n\n Women with known hypothyroidism", - "brief_summary": "There is general agreement that thyroid gland function should be assessed in pregnant women. When the gland produces too little thyroid hormone (hypothyroidism), all of the woman's bodily functions slow down, and there are problems with her baby's development. Until now, physicians have identified this problem on an individual basis (case-finding), but this approach misses many of the cases. Our trial aims to replace case-finding with a routine blood test that is highly effective at detecting hypothyroidism, thereby allowing treatment to correct the deficiency. This approach can eventually be implemented throughout the United States.", - "NCTID": "NCT00818896" - }, - { - "brief_title": "Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism", - "phase": "Phase 1", - "drugs": "['Ferrous sulfate tablets 325 mg, po, TID', 'Ferrous sulfate plus levothyroxine']", - "drugs_list": [ - "Ferrous sulfate tablets 325 mg", - "po", - "TID", - "Ferrous sulfate plus levothyroxine" - ], - "diseases": "['Iron Deficiency Anemia', 'Subclinical Hypothyroidism']", - "diseases_list": [ - "Iron Deficiency Anemia", - "Subclinical Hypothyroidism" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis and laboratory confirmation of iron deficiency anemia and subclinical hypothyroidism \n\n Must be able to swallow tablets \n\n ", - "exclusion_criteria": ": \n\n Multifactorial anemia or anemia due to other reasons \n\n Iron deficiency anemia requiring urgent intervention- cardiac ischemia, severe anemia, GI or GU losses due to malignancy and or acute/subacute big loses by respiratory, G\u0130, GU, etc. system \n\n Prior thyroid disorder and/or treatment history \n\n Presence of any other co-morbid disease like renal insufficiency/ failure, coronary heart disease, hypertension, diabetes mellitus, any endocrine system disease other than subclinical hypothyroidism", - "brief_summary": "To determine whether iron deficiency anemia can be an indication for the treatment of subclinical hypothyroidism.", - "NCTID": "NCT00535561" - }, - { - "brief_title": "Phase 4 Study in Secondary Hypothyroidism: Body Weight Adapted Thyroxin Treatment and Triiodothyronine Supplementation", - "phase": "Phase 4", - "drugs": "['Thyroxin, Triiodothyronine']", - "drugs_list": [ - "Thyroxin", - "Triiodothyronine" - ], - "diseases": "['Secondary Hypothyroidism', 'Hypopituitarism', 'Hyperlipidemias']", - "diseases_list": [ - "Secondary Hypothyroidism", - "Hypopituitarism", - "Hyperlipidemias" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n hypopituitarism of at least 3 axes (TSH plus gonadotropin, somatotropin, corticotropin or ADH deficiency) \n\n termination of surgical or radiation treatment of pituitary tumors at least six month before study entry \n\n BMI of 20 - 39.9 kg/m2 \n\n non-smoking status. \n\n ", - "exclusion_criteria": ": \n\n history of cardiovascular or pulmonary diseases \n\n current thyroxin dosage > 1.6 \u00b5g/kg bw \n\n pregnancy \n\n epilepsy \n\n cerebrovascular diseases \n\n nodular goiter", - "brief_summary": "The purpose of this study is to determine whether a body weight adjusted dose of thyroxin is superior to treatment guided by laboratory results of thyroxin hormones in patients with central hypothyroidism. Moreover beneficial effects of triiodthyronine supplementation are investigated.", - "NCTID": "NCT00360074" - }, - { - "brief_title": "Thyroxin Treatment in Sub Clinical Hypothyroidism, on the Apnea Hypopnea Index Score, Lipids and Highly Sensitive CRP", - "phase": "Phase 3", - "drugs": "['levothyroxine', 'sugar pill']", - "drugs_list": [ - "levothyroxine", - "sugar pill" - ], - "diseases": "['Dyslipidemia']", - "diseases_list": [ - "Dyslipidemia" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients >18 years old \n\n With Subclinical hypothyroidism defined as serum TSH concentration above 5.0 IU/mL when serum FT4 level is within the reference range \n\n With OSA defined as mild OSA: AHI 5 to 15/h; moderate OSA:AHI 15 to 30/h; and severe OSA: AHI greater than 30/h (30) will be enrolled. \n\n With confirmed sustained subclinical hypothyroidism, thus excluding patients with a temporary condition such as that in recovery from a non-thyroidal illness, measurement of TSH and FT4 will be conducted within four weeks before randomization. \n\n ", - "exclusion_criteria": ": \n\n Current treatment with Levothyroxine and lipid lowering medications or within two months before randomization. \n\n Conditions known to cause dyslipidemia e.g. uncontrolled diabetes mellitus (HbA1c >9), alcoholism and some medication use e.g. Estrogens. Glucocorticoids, Retinoids or Interferons. \n\n Conditions indicating levothyroxine treatment (34); including TSH levels more than 10 mU/l, clear symptoms or signs associated with thyroid failure and not related to OSA . e.g. goiter. \n\n State of pregnancy, Breast feeding or allergy to levothyroxine.", - "brief_summary": "Obstructive sleep apnea (OSA) and hypothyroidism are both commonly found in clinical practice, and share a number of symptoms and clinical features. It has been shown that hypothyroid subjects are at high risk of developing sleep disorder breathing and OSA, and adequate thyroxine treatment may reduce the sleep disordered breathing.. However, the time-course and effect of treating subclinical hypothyroidism in OSA patients on the respiratory events during sleep is not known.~Subclinical hypothyroidism is associated with an increased risk of coronary heart disease (CHD). Dyslipidemia is a known complications of subclinical hypothyroidism and the effect of thyroxine treatment on lipid profile is controversial . Some reports suggested higher serum high-sensitivity C-reactive protein (hs-CRP), than healthy subjects; however, the effect of levothyroxine is controversial.~This project will help us to know if the treatment of subclinical hypothyroidism will improve the symptoms and reduce the progression of OSA, which may improve patients' quality of life by reducing the complication of OSA (hypertension, , depression, Cardiovascular diseases, etc.) or may even reduce mortality.It will help us to know the effect of subclinical hypothyroidism treatment on of lipid profiles and hs-CRP.", - "NCTID": "NCT01486667" - }, - { - "brief_title": "Mechanistic Study of Subclinical Hypothyroidism In the Elderly", - "phase": "", - "drugs": "['Levothyroxine', 'Liothyronine', 'Thyrotropin-Releasing Hormone']", - "drugs_list": [ - "Levothyroxine", - "Liothyronine", - "Thyrotropin-Releasing Hormone" - ], - "diseases": "['Subclinical Hypothyroidism']", - "diseases_list": [ - "Subclinical Hypothyroidism" - ], - "enrollment": "14.0", - "inclusion_criteria": "inclusion criteria: \n\n men and women aged 70 and older \n\n TSH between 4.5 and 19.9 mU/L as an outpatient \n\n ability to provide informed consent \n\n ", - "exclusion_criteria": ": \n\n Laboratory Tests: \n\n TSH <4.5 mU/L or >20 mU/L on repeat testing at least four weeks later or free T4 level outside the reference range \n\n thyroid peroxidase (TPO) antibody positive \n\n abnormal liver function tests (LFTs >3 x upper limit of normal) \n\n hemoglobin <11 g/dL \n\n Surgeries or Procedures: \n\n thyroid surgery \n\n pituitary surgery \n\n bariatric surgery \n\n bowel resection involving the jejunum and upper ileum \n\n radioactive iodine therapy \n\n radiation treatments to head or neck \n\n Medical Conditions: \n\n diagnosis of pituitary disease \n\n diagnosis of amyloidosis, sarcoidosis, hemochromatosis \n\n diagnosis of adrenal insufficiency \n\n obesity with BMI > 35 mg/kg2 \n\n history of stroke \n\n chronic or ongoing angina, Class II or higher congestive heart failure, or uncontrolled hypertension with current blood pressure greater than 160/100 \n\n diabetes mellitus with hemoglobin A1C level greater than 8.0% in the past six months \n\n celiac sprue, Crohn's disease, ulcerative colitis, Zollinger-Ellison syndrome \n\n renal insufficiency with calculated glomerular filtration rate <45 cc/min \n\n cognitive impairment with Mini Mental State Exam[30] <24/30 \n\n history of any seizures \n\n unstable medical or psychological condition in the judgment of the principal investigator \n\n Medications: \n\n thyroid hormone preparations \n\n antithyroid drugs \n\n medications that interfere with the absorption or metabolism of thyroid hormone \n\n medications that interfere with the TRH stimulation test \n\n proton pump inhibitors", - "brief_summary": "Subclinical hypothyroidism, defined as an elevated TSH in the setting of normal thyroid hormone levels, is a common diagnosis in the elderly. The purpose of this study is to examine the hypothalamic-pituitary-thyroid axis in men and women aged 70 years and older with persistent subclinical hypothyroidism. To evaluate the mechanism behind this condition, participants will undergo thyrotropin releasing hormone stimulation testing at 3 visits: baseline and while taking two different thyroid hormone preparations, levothyroxine and liothyronine. The investigators will also assess physiologic responses to these two different thyroid hormone medications to help us understand how the thyroid works in advanced age.", - "NCTID": "NCT02399475" - }, - { - "brief_title": "Thyroxine Titration Study", - "phase": "Phase 4", - "drugs": "['Thyroxine']", - "drugs_list": [ - "Thyroxine" - ], - "diseases": "['Hypothyroidism']", - "diseases_list": [ - "Hypothyroidism" - ], - "enrollment": "55.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female subjects >18 years of age \n\n Primary hypothyroidism \u22656 months duration arising from autoimmune hypothyroidism, thyroidectomy or radioiodine treatment \n\n Thyroxine dose \u2265100 mcg/day \n\n No change in thyroxine dose in past 2 months \n\n Serum TSH of 0.1-4.8 mU/L \n\n Adequate contraceptive measures for women of childbearing age \n\n ", - "exclusion_criteria": ": \n\n Major systemic illness affecting quality of life or likely to affect participation in the study \n\n Treatment with T3 currently or in past 2 months \n\n History of thyroid cancer requiring suppression of TSH secretion by thyroxine \n\n Ischaemic heart disease - previous myocardial infarction, angina or coronary artery revascularisation \n\n Renal failure: serum creatinine >135 micromol/L \n\n Known liver disease with alkaline phosphatase or ALT >2x upper limit of reference range \n\n Bony fracture in past 3 months or Paget's disease of bone \n\n Secondary (central) hypothyroidism or hypopituitarism", - "brief_summary": "The aim of the study is to examine the effects of fine titration of thyroxine dosage on symptoms of hypothyroidism, wellbeing and quality of life. The hypothesis is that symptoms of hypothyroidism, wellbeing and quality of life will be improved in thyroxine-treated subjects when serum thyrotropin (TSH) is suppressed and/or in the lower reference range, compared to when TSH is in the upper reference range.", - "NCTID": "NCT00111735" - }, - { - "brief_title": "Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment", - "phase": "", - "drugs": "['Levothyroxine', 'Desiccated thyroid extract']", - "drugs_list": [ - "Levothyroxine", - "Desiccated thyroid extract" - ], - "diseases": "['Primary Hypothyroidism.']", - "diseases_list": [ - "Primary Hypothyroidism." - ], - "enrollment": "180.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients will be between the ages of 18 to 65 and will have been on levothyroxine for primary hypothyroidism for at least 6 months. \n\n ", - "exclusion_criteria": ": \n\n Patients will be excluded if they have the following problems: pregnancy, plan for pregnancy in the next 12 months, cardiac disease, especially coronary artery disease, chronic obstructive lung disease, malabsorption disorder, gastrointestinal surgeries, significant renal or liver dysfunction, seizure disorders, thyroid and non-thyroid active cancers, uncontrolled psychosis, psychotropic medication use, steroid use, amiodarone, chemotherapy for cancer, iron supplement more than 325mg per day, carafate/ proton pump inhibitor use, cholestyramine use, and those with recent PCS orders who are expected to move out of the geographic area, age less than 18 years old or older than 65 years old. \n\n Patients scheduled for deployment will be excluded.", - "brief_summary": "Our hypothesis is that hypothyroid patients on DTE may have a decrease in symptoms, an improvement of cognitive function, and an increase in sense of well-being/ quality of life equivalently compared with L-T4.", - "NCTID": "NCT01739972" - }, - { - "brief_title": "Treatment Trial of Subclinical Hypothyroidism in Down Syndrome", - "phase": "", - "drugs": "['Levothyroxine']", - "drugs_list": [ - "Levothyroxine" - ], - "diseases": "['Down Syndrome', 'Subclinical Hypothyroidism']", - "diseases_list": [ - "Down Syndrome", - "Subclinical Hypothyroidism" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria: \n\n Males and females, ages 8 - 20 years \n\n Diagnosis of Down syndrome \n\n Subclinical hypothyroidism: TSH level between 5 - 10 mIU/L, normal T4 \n\n Parental/guardian permission (informed consent) and if appropriate, child assent \n\n Females who are at least 11 years of age or who are menarchal must have a negative urine/serum pregnancy test \n\n Committed to adherence to levothyroxine treatment and study completion \n\n ", - "exclusion_criteria": ": \n\n Pregnancy \n\n Type 1/Type 2 diabetes \n\n Chronic medical conditions or medication use that can affect growth, nutrition, blood glucose, insulin secretion, or thyroid function (such as lithium or certain seizure medications) \n\n Current use of levothyroxine or anti-thyroid hormone \n\n Cyanotic congenital heart disease, or pulmonary hypertension (as described by last echo report in subjects with CHD), or congenital heart disease considered medically unstable by the study cardiologists", - "brief_summary": "The purpose of this research study is to learn about the effects of treating subclinical hypothyroidism (SCH) with thyroid hormone replacement in children and adolescents with Down syndrome (DS). We hypothesize that treatment of SCH with thyroid hormone replacement will improve cardiometabolic health and quality of life.", - "NCTID": "NCT01832753" - }, - { - "brief_title": "The TRUST Study - Depression Substudy", - "phase": "Phase 4", - "drugs": "['Levothyroxine', 'Placebo']", - "drugs_list": [ - "Levothyroxine", - "Placebo" - ], - "diseases": "['Subclinical Hypothyroidism', 'Depression']", - "diseases_list": [ - "Subclinical Hypothyroidism", - "Depression" - ], - "enrollment": "426.0", - "inclusion_criteria": "inclusion criteria: \n\n Community-dwelling patients aged >= 65 years with subclinical hypothyroidism \n\n Written informed consent \n\n ", - "exclusion_criteria": " \n\n Subjects currently on Levothyroxine or antithyroid drugs, amiodarone or lithium \n\n Recent thyroid surgery or radio-iodine (within 12 months) \n\n Grade IV NYHA heart failure \n\n Prior clinical diagnosis of dementia \n\n Recent hospitalisation for major illness or elective surgery (within 4 weeks) \n\n Terminal illness \n\n Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption \n\n Subjects who are participating in ongoing RCTs of therapeutic interventions (including CTIMPs) \n\n Plan to move out of the region in which the trial is being conducted within the next 2 years (proposed minimum follow-up period)", - "brief_summary": "Mild thyroid failure is a common condition among older adults and has been associated with numerous adverse effects on health, such as cardiovascular disease, cognition disturbances and muscular problems. Mild thyroid failure has also been associated with an increased risk of developing depression. To date, only few studies have investigated the effect of thyroid hormone replacement on depression in patients with mild thyroid failure. This study therefore aims to assess whether thyroid hormone replacement in older adults with mild thyroid failure is associated with a decrease in the presence of depressive symptoms. This study forms a substudy of a large international study on thyroid hormone replacement in older adults with mild thyroid failure (the TRUST study).", - "NCTID": "NCT01853579" - }, - { - "brief_title": "Erythropoietin in the Prevention of Acute Mountain Sickness", - "phase": "Phase 4", - "drugs": "['Erythropoietin']", - "drugs_list": [ - "Erythropoietin" - ], - "diseases": "['Acute Mountain Sickness']", - "diseases_list": [ - "Acute Mountain Sickness" - ], - "enrollment": "39.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy adults \n\n ", - "exclusion_criteria": ": \n\n History of serious illness \n\n Current smoker or Hemoglobin >15.5gm/dL \n\n Uncontrolled hypertension", - "brief_summary": "Acute mountain sickness (AMS) is a syndrome of nonspecific symptoms and is therefore subjective. The Lake Louise Consensus Group defined acute mountain sickness as the presence of headache in an unacclimatized person who has recently arrived at an altitude above 2,500 m plus the presence of one or more of the following: gastrointestinal symptoms (anorexia, nausea, or vomiting), insomnia, dizziness, and lassitude or fatigue. An increase in RBC mass is a natural feature of altitude acclimatization. Hypoxia-induced erythropoietin (EPO) secretion begins hours after ascent and stimulates bone marrow production of red blood cells, but this takes weeks to effect an increase in red cell mass . Therefore, it is feasible that EPO therapy weeks before altitude exposure decrease high altitude illness.~In 1996, Young et al in U.S. Army Research Institute of Environmental Medicine (USARIEM) reported that autologous erythrocyte infusion did not ameliorate the decrement in maximal oxygen uptake at 4,300m altitude despite increasing arterial oxygen carrying capacity. On the basis of this report, USARIEM did not recommend use of recombinant EPO for altitude acclimatization.~However, increases in erythrocyte count, hematocrit and hemoglobin associated with EPO therapy have been shown to decrease fatigue and increase work capacity and exercise tolerance. In addition, improvement in CNS function and cognitive ability has been noted with EPO therapy. Subjective benefits include improvement in sleep habits, tolerance to cold; decreased dyspnea, anginal symptoms and tachycardia and improved appetite, all of which are symptoms associated with high altitude illness.~The investigators also reported improved muscle energy metabolism with EPO in dialysis patients, but not with RBC transfusion.~In this study, the investigators will conduct a randomised controlled trial to assess the effect of EPO administration on AMS at an altitude of 4,130 m.", - "NCTID": "NCT01665781" - }, - { - "brief_title": "Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism", - "phase": "Phase 4", - "drugs": "['Growth hormone', 'Growth hormone treatment and puberty']", - "drugs_list": [ - "Growth hormone", - "Growth hormone treatment and puberty" - ], - "diseases": "['Hypothyroidism']", - "diseases_list": [ - "Hypothyroidism" - ], - "enrollment": "16.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients should have clinical and biochemical evidence of hypothyroidism, T4 less than 5.0 ng /dl , fT4 less than 1.0 mcg/dl and TSH of more than 10. Patients with prolonged hypothyroidism should have growth failure and delayed bone age of at least 2 SD from the mean. Patients with short term hypothyroidism should have normal growth velocity and bone age. \n\n Females 8 to 16 years old. \n\n Males 9 to 17 years old. \n\n Patients without any chronic medical conditions. \n\n Availability of a parent or guardian to attend study visits with the patient and to be actively involved in the patient treatment plan. \n\n Give written informed consent prior to any study specific screening procedure with the understanding that the patient has the right to withdraw from the study at any time without penalty. \n\n ", - "exclusion_criteria": ": \n\n Taking medications that affect their growth. (eg. Systemic corticosteroids, anabolic steroids) \n\n Experiencing other health problems/conditions that affect their growth rate such as growth hormone deficiency, Cushing Syndrome, rickets, and chronic diseases. \n\n Patients with any condition that is a contraindication for GH therapy would include conditions such as an active tumor, impaired glucose tolerance, neurofibromatosis (worsening of neurofibromatosis), and hypertrophy of tonsils and adenoids with sleep apnea. Contraindications for patients for GNRHa therapy would include a severe systemic reaction to GNRHa which is rare, osteopenia, and osteoporosis, because delaying puberty will worsen the condition. \n\n Moving to a location that the patient will not be able to be followed by a pediatric endocrinologist. \n\n Patient is not willing to continue with the study. -", - "brief_summary": "The purpose of this study is to see if giving growth hormone and Lupron along with thyroid hormone will improve final height in patients with long term hypothyroidism. Lupron is a medicine which is used to delay puberty and to prevent early closure of growing bones which might increase growth potential. Growth hormone is used to restore growth rate. This study will include children with short term and long term hypothyroidism.", - "NCTID": "NCT00206375" - }, - { - "brief_title": "Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone", - "phase": "", - "drugs": "['thyroxine', 'thyroxine and triiodothyronine']", - "drugs_list": [ - "thyroxine", - "thyroxine and triiodothyronine" - ], - "diseases": "['Hypothyroidism']", - "diseases_list": [ - "Hypothyroidism" - ], - "enrollment": "36.0", - "inclusion_criteria": "inclusion criteria: \n\n Premenopausal women with overt primary hypothyroidism (reduced T4 concentration accompanied by increased TSH concentration at the time of initial diagnosis) who did not receive thyroid hormones \n\n ", - "exclusion_criteria": ": \n\n Peri- and postmenopause \n\n Pregnancy \n\n Major comorbidity \n\n Use of drugs that affect metabolism or bioavailability of thyroid hormones preparations.", - "brief_summary": "The objective of this study was to analyze the features of monotherapy with L-T4 in comparison with combined therapy with L-T4 and L-T3 in patients with primary hypothyroidism.", - "NCTID": "NCT00715572" - }, - { - "brief_title": "Study of Optimal Replacement of Thyroxine in the Elderly", - "phase": "Phase 4", - "drugs": "['Levothyroxine', 'Levothyroxine']", - "drugs_list": [ - "Levothyroxine", - "Levothyroxine" - ], - "diseases": "['Hypothyroidism']", - "diseases_list": [ - "Hypothyroidism" - ], - "enrollment": "48.0", - "inclusion_criteria": "inclusion criteria: \n\n Males and Females aged 80 years or older \n\n Diagnosed with hypothyroidism and treated with Levothyroxine for at least 6 months \n\n Living independently in the community \n\n All TSH results within the range 0.4 - 4mU/L in the 3 months before commencing the study \n\n Participant has provided written informed consent for participation in the study, prior to any study-specific procedures \n\n ", - "exclusion_criteria": ": \n\n Established dementia and therefore deemed incapable of providing informed consent. \n\n Other medical conditions which, inthe opinion of the Chief Investigator, would prevent them from participating in the study (for example, end stage cancer, severe chronic health conditions where the patient is housebound) \n\n Nursing Homes or Residential Care Home residents \n\n Individuals with thyroid cancer: since they require high doses of LT4 to suppress their serum TSH \n\n Individuals on 25 mcg dailty of LT4: dose reduction will mean that they stop thyroid replacement treatment \n\n Non english speaking individuals \n\n Participation in any other investigational trials within the last 3 months \n\n Participants prescribed medications that can affect thyroid function (amiodarone, lithium, carbimazole or propylthiouracil) \n\n Known or suspected lactose intolerance (this would have implications for the proposed over-encapsulated IMP)", - "brief_summary": "All patients with hypothyroidism are currently treated the same way, regardless of age. The investigators want to look at whether people aged 80 years or older would benefit from being treated with lower doses of levothyroxine. There are three reasons why the investigators think this could be beneficial, but this is not yet proven:~Some older people with hypothyroidism may have few symptoms.~Doctors look at the amount of Thyroid Stimulating Hormone (TSH) in the patient's blood to decide the dose of Thyroxine received. The standard normal TSH range used to determine the dose of levothyroxine is from younger people. The investigators wonder whether this is appropriate to all age ranges particularly as the investigators know that older people may normally have higher TSH values.~If TSH levels are too low there may be a slight increased risk of problems such as brittle bones or an irregular heartbeat.~The best way to test whether older people benefit from lower doses of levothyroxine is by a large clinical trial. Before the investigators can do this, the investigators need to run a smaller clinical trial called a pilot study (SORTED 1) to examine whether this is practical and acceptable. The pilot study aims to recruit 50 patients with hypothyroidism aged 80 or above.~Participants will be randomly allocated to receive their routine or lower dose of levothyroxine. Follow-up will be conducted over approximately 25 weeks.~The investigators also propose a qualitative study (SORTED 2) to specifically understand patient's willingness to take part in a RCT and participant's experience of the intervention.~Finally, the investigators propose a retrospective cohort study of 400 treated hypothyroid patients aged 80 years or more registered in 2008 in Primary Care Practices with the aim of studying outcomes after 4 years. The cohort study will collect data required to inform a sample size calculation for a future full study where the primary outcome will be 4 year mortality.", - "NCTID": "NCT01647750" - }, - { - "brief_title": "Clinical and Genetic Analysis in Congenital Hypothyroidism Due to Thyroid Dysgenesis.", - "phase": "", - "drugs": "['Clinical and radiologic exams and blood samples']", - "drugs_list": [ - "Clinical and radiologic exams and blood samples" - ], - "diseases": "['Congenital Hypothyroidism']", - "diseases_list": [ - "Congenital Hypothyroidism" - ], - "enrollment": "558.0", - "inclusion_criteria": "inclusion criteria: \n\n - Patient: newborn (0-27 days) or infant (28 days 23 months), or child or adult with congenital hypothyroidism (that is to say with a TSH > 15 mU / ml at screening on filter paper and / or plasma TSH> 10 mU / ml) diagnosed in the first months of life, whatever their age, sex, weight and size. \n\n Subjects with blood levels of free thyroid hormones (FT3 and FT4) in the standards will be described as having subclinical hypothyroidism. \n\n If treatment with L-thyroxine could be stopped without relapse (that is to say, always with a TSH <5 mU / ml with different controls), hypothyroidism is said to be transient, whatever the age of discontinuation of treatment. \n\n No pre or neonatal goitre by palpation or ultrasound thyroid \n\n negative perchlorate test (ie decreased rate of iodine captation <10% at 2h injection of perchlorate) when the thyroid gland in place \n\n No self-immunity known to thyroid in children with and / or his mother (defined by a antithyroperoxidase antibodies and / or antithyroglobulin) \n\n Signature of free and informed consent by the patient or his legal representative \n\n Affiliation or enjoying a social security system \n\n ", - "exclusion_criteria": ": \n\n Presence of markers antithyroid autoimmunity in children and / or mother (antithyroperoxidase antibodies and / or antithyroglobulin) \n\n Pre or neonatal goiter on palpation or ultrasound thyroid \n\n Test positive perchlorate (ie salting rate of iodine> 10% at 2 injection perchlorate) \n\n Patients of foreign origin returned to their country will be excluded from the study.", - "brief_summary": "Congenital hypothyroidism (CH) is a rare disease that affects 1 in 3500 newborn. This condition is detected consistently since the late 1970s in France, which has led to early care and a significant improvement in prognosis and intellectual stature of these children. However neurodevelopmental disorders persist in 10-15% of cases. More associated diseases have been reported in approximately 10% of cases. These observations are in most cases poorly understood. The family nature of the CH is now well recognized and a dozen genes involved up to now. However, in the majority of cases (HC not due to a disorder of the organification of iodine), few mutations have been found in the reported number of patients (5-10%), suggesting the involvement of other genes. Some of the genes have been implicated in particular specific syndromic forms but many pathological associations remain unexplained. Also, a more complete genetic elucidation of CH would enable a better understanding of its etiology and thus its risk of familial recurrence (frequently asked questions by parents of children with CH) and secondly the presence of associated pathologies.~Main goal: to describe the population with CH (not due to a disorder of the organification of iodine) not only on clinical, biological and radiological (phenotypic analysis) but also on the genetic level to establish a genotype / phenotype correlation.", - "NCTID": "NCT01916018" - }, - { - "brief_title": "Measurement of Hormonal Concentration in Chylothorax Fluid in Infants With Congenital Chylothorax", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Congenital Chylothorax']", - "diseases_list": [ - "Congenital Chylothorax" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria: \n\n Infants with congenital chylothorax requiring thorax drain \n\n ", - "exclusion_criteria": ": \n\n none", - "brief_summary": "Late onset Hypothyroidism was found in infant with congenital hypothyroidism. The hypothesis is that infants with congenital hypothyroidism may lose thyroxin and other hormones via the chylothorax fluid causing transient hypothyroidism. In this study hormonal concentration will be measured in the chyle as well as hormonal serum level.", - "NCTID": "NCT00267345" - }, - { - "brief_title": "Post Partum Thyroiditis 2: Long Term Observations", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Hypothyroidism']", - "diseases_list": [ - "Hypothyroidism" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Defined group of women who tested positive for post partum thyroiditis in 1985. \n\n Control group randomly picked from those who tested negative. \n\n ", - "exclusion_criteria": ": \n\n -", - "brief_summary": "The study tries to determine if post partum thyroiditis has marked long term (20 years after partum) risk for developing hypothyroidism.", - "NCTID": "NCT00287144" - }, - { - "brief_title": "Physiotherapeutic Intervention in Children With Chronic Functional Constipation", - "phase": "", - "drugs": "['diaphragmatic breathing, isometric training of the abdominal muscles and abdominal massage']", - "drugs_list": [ - "diaphragmatic breathing", - "isometric training of the abdominal muscles and abdominal massage" - ], - "diseases": "['Chronic Constipation']", - "diseases_list": [ - "Chronic Constipation" - ], - "enrollment": "72.0", - "inclusion_criteria": "inclusion criteria: \n\n Less than 2 per week defecation \n\n Fecal incontinence \n\n Retentive behavior \n\n Pain at defecation and \n\n Hard stools \n\n ", - "exclusion_criteria": ": \n\n Medication use (calcium, antacid, diuretic and hematinic) \n\n Organic causes (spina bifid, hypothyroidism, hirschusprung disease, developmental delay neuropsychomotor, kidney disease and metabolic diseases)", - "brief_summary": "The purpose of this study is to determine whether physiotherapy is effective in the treatment of the chronic functional constipation in children.", - "NCTID": "NCT00906971" - }, - { - "brief_title": "A Study on the Mechanism of Cough Hypersensitivity", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cough']", - "diseases_list": [ - "Cough" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n chronic cough group: \n\n cough lasting \u2265 8 weeks,characterized by irritating dry cough. \n\n sensitive to fumes\uff0cdust,the odorous and cold air. \n\n with normal chest x-rays. 4.17-70 years old. \n\n 5.without smoking history. healty controls group: 1.17-70 years old. 2.without smoking hitory or stop smoking for more than 2 years. 3.without chronic cough. 4.without chronic respiratory diseases. 5.without chronic heart, liver, kidney,and autoimmune disease. 6.with normal chest x-rays. 7.with normal pulmonary ventilation function,and histamine challenge test showed negative result. \n\n ", - "exclusion_criteria": ": \n\n chronic cough group and healty controls group: \n\n with respiratory tract infection within 8 weeks. \n\n with chronic respiratory diseases or severe heart, liver, kidney,and autoimmune disease. \n\n using Angiotensin-Converting Enzyme Inhibitors(ACEI),bronchodilators,glucocorticosteroid,antihistaminics within one week. \n\n women during pregnancy or lactation. \n\n patients with malignant tumours.", - "brief_summary": "The aim of this study is described as follows,~To establish a validated method to test cough reflex sensitivity conducted by transient receptor potential vanilloid 1(TRPV1).~To observe the variance of cough reflex sensitivity conducted by transient receptor potential ankyrin 1(TRPA1) of chronic patients and the relationship between cough reflex sensitivity conducted by TRPA1 and conducted by TRPV1.~To study the distribution of TRPA1 and TRPV1 channels and their relationship to cough reflex sensitivity.", - "NCTID": "NCT02591550" - }, - { - "brief_title": "The Effect of Donepezil on Sedation and Other Symptoms", - "phase": "Phase 3", - "drugs": "['Donepezil', 'Placebo']", - "drugs_list": [ - "Donepezil", - "Placebo" - ], - "diseases": "['Advanced Cancer']", - "diseases_list": [ - "Advanced Cancer" - ], - "enrollment": "27.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient with drowsiness/sedation caused by opiate for > 3 days and its intensity more or equal to 3/10 (0 to 10 scale; 0 = no sedation, 10=worst possible sedation). \n\n Patient receiving a regular dose of a strong opioid for the treatment of cancer pain, and no dose changes or dose change within 50% for at least 48 hours.Regular administration, defined as short acting opioids oral or parenteral every 4 hours around clock, slow release oral opioids every 12 hs or 24 hs, or transdermal opioids every 72 hours. Strong opioids include morphine, hydromorphone, methadone, fentanyl, and oxycodone. \n\n Patient with relatively intact cognition defined by the Mini Mental State Examination according to age and educational level. A score of 24 or above is usually considered normal. \n\n Patient willing to engage in follow up visit with a nurse by phone on day 2-7 (each day), 11 and 15 of the study and to return for follow up visit on day 8 of treatment. If patient is unable to come to clinic, assessment will be performed through telephone. \n\n Sexually active females at risk of being pregnant with a negative urine pregnancy test \n\n Written consent form signed. \n\n Patients are 18 years or older \n\n Concurrent radiation treatment (defined as 10 or less fractions for a palliative indication) is allowed \n\n Concurrent chemotherapy is allowed, if the first two cycles have been well tolerated (defined as no grade 3 or 4 non-hematological toxicity) \n\n ", - "exclusion_criteria": ": \n\n Major contraindication to donepezil i.e. hypersensitivity to donepezil or piperidine derivatives. \n\n Patients in whom a major change in opiate dose, analgesia requirements, anesthetic procedures or general anesthetic is expected over the next seven days. \n\n Treatment with anti-cholinergic agents (i.e., glycopyrrolate) \n\n Patients taking Methylphenidate. \n\n Patients with tube feeding (due to difficulty of accurate assessing some of the symptoms such as appetite and anorexia). \n\n History of ongoing arrhythmia causing a rhythm other than a sinus rhythm", - "brief_summary": "Primary Objective:~1. To determine the effectiveness of donepezil as compared to placebo for the management of opiate-induced sedation/drowsiness in patients with stable cancer pain~Secondary Objectives:~To assess the side-effects in both groups of 1 week treatment of 5 mg donepezil and placebo~To assess the effects of donepezil on fatigue (FACIT-Fatigue), and other symptoms (Anderson Symptom Assessment Scale)~To assess the effects of donepezil on cognition (Symbol Digit Modalities Test)~To assess the effects of donepezil on constipation (number of bowel movements)", - "NCTID": "NCT00352664" - }, - { - "brief_title": "Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children", - "phase": "Phase 3", - "drugs": "['thyroid hormone and folinic acid']", - "drugs_list": [ - "thyroid hormone and folinic acid" - ], - "diseases": "['Down Syndrome']", - "diseases_list": [ - "Down Syndrome" - ], - "enrollment": "175.0", - "inclusion_criteria": "inclusion criteria: \n\n patient with a karyotype demonstrating homogeneous, free or Robertsonian translocation trisomy 21 \n\n patient having undergone a cardiac ultrasound not demonstrating any severe heart disease \n\n patient aged 6 to 18 months at inclusion \n\n ", - "exclusion_criteria": ": \n\n congenital hypothyroidism \n\n hypothyroidism demonstrated by laboratory tests (TSH > 7mUI/l) \n\n presenting or having presented hyperthyroidism \n\n presenting or having presented leukaemia \n\n presenting or having presented West syndrome or any other form of epilepsy or unstable neurological disease \n\n presenting or having presented signs of central nervous system distress: stroke, postoperative hypoxia, meningitis) \n\n presenting severe heart disease on cardiac ultrasound, with haemodynamic effects \n\n presenting non-controlled cardiac arrhythmia \n\n Apgar < 7 to 5 min at birth \n\n Gestational age < 231 days (33 gestation weeks)", - "brief_summary": "Evaluation of the following in very young children with Down syndrome:~the efficacy of systematic treatment with L-thyroxine at controlled doses (clinically and by ultrasensitive thyreostimulating hormone (TSH) assay),~the efficacy of systematic folinic acid treatment at a dose of 1 mg/kg/o.i.d,~any interaction between these two treatments.", - "NCTID": "NCT01576705" - }, - { - "brief_title": "Effects of Gaseous Cryotherapy on Knee ROM After TKA: A Feasibility Study", - "phase": "", - "drugs": "['Cryoton \u2122', 'Control ice bag']", - "drugs_list": [ - "Cryoton \u2122", - "Control ice bag" - ], - "diseases": "['Osteoarthritis, Knee']", - "diseases_list": [ - "Osteoarthritis", - "Knee" - ], - "enrollment": "65.0", - "inclusion_criteria": "inclusion criteria: \n\n Planned unilateral TKA done at Verdun Hospital. \n\n Capacity to communicate in French or English. \n\n ", - "exclusion_criteria": ": \n\n Complications during or after the surgery. \n\n Inability to perform the tests due to other diseases. \n\n Contraindications to cryotherapy such as Raynaud's disease, cryoglobulinemia, hemoglobinopathy, polyneuropathy associated with temperature sensitivity deficits or allergy to cold.", - "brief_summary": "A pilot study was performed to investigate the feasibility of a large randomized controlled trial (RCT) to assess the effects of hyperbaric gaseous cryotherapy (HGC) on the change in knee flexion range of motion in the first two days after total knee arthroplasty.", - "NCTID": "NCT02516280" - }, - { - "brief_title": "Vocal Acoustic Biomarkers in Depression", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Depression']", - "diseases_list": [ - "Depression" - ], - "enrollment": "125.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 - 80. \n\n Written informed consent. \n\n Current MDD according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) \n\n Recently started to receive or about to start receiving treatment for MDD \n\n Quick Inventory of Depressive Symptomatology - Clinician-Rated (QIDS-C) and QIDS-IVR scores equal or greater than 10 at baseline visit. \n\n ", - "exclusion_criteria": ": \n\n Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment. \n\n History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, other than alcohol, active within the last 12 months. \n\n History or current diagnosis of dementia. \n\n Diagnosis or history of hypothyroidism.", - "brief_summary": "This Phase II SBIR study will replicate pilot study methods establishing computer-automated methods for assessing depression severity using interactive voice response system technology and demonstrating feasibility of obtaining measures of depression severity and treatment response through vocal acoustic analysis of speech samples obtained over the telephone. The study will automate vocal acoustic analysis methods, evaluate applicability to other patient populations (non-English speakers, children/young adult, and geriatric), and further develop multivariate acoustic models to enhance biomarker sensitivity to treatment response and prediction of the response likelihood for individual patients.", - "NCTID": "NCT00844948" - }, - { - "brief_title": "Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer", - "phase": "Phase 3", - "drugs": "['Lapatinib', 'Paclitaxel']", - "drugs_list": [ - "Lapatinib", - "Paclitaxel" - ], - "diseases": "['Neoplasms, Gastrointestinal Tract']", - "diseases_list": [ - "Neoplasms", - "Gastrointestinal Tract" - ], - "enrollment": "273.0", - "inclusion_criteria": "inclusion criteria: \n\n Specific Information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject eligibility is provided in the Investigator's Brochure (IB) Pilot Part \n\n Subjects eligible for enrollment in the Pilot Part of the study must meet all of the following criteria: \n\n Signed informed consent \n\n Male or female; \u2265 20 years (at the time of giving consent) \n\n Any histologically or cytologically confirmed gastric carcinoma independent of tumor ErbB2 status \n\n Subjects who have received one prior regimen for gastric carcinoma and developed disease progression or recurrence. The regimen must have contained 5-fluoropyrimidine and/or cisplatin \n\n Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by echocardiogram (ECHO). Multigated acquisition (MUGA) scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive (LVEF of \u226550% required if normal range of LVEF is not provided by institution) \n\n Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 \n\n Able to swallow and retain oral medication \n\n Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study \n\n Washout period from the prior last therapy as follows; Chemotherapy (except for agents below) 4 weeks (I.V) Chemotherapy (except for agents below) 2 weeks (P.O) Trastuzumab, Bevacizumab 4 weeks Mitomycin-C, nitrosourea 6 weeks Radiotherapy, Immunotherapy, Biologic therapy and Surgery (except for minor surgical procedure) 2 weeks \n\n Willing to complete all screening assessments as outlined in the protocol \n\n Adequate organ function as defined in Table 2 Baseline Laboratory Values \n\n Able to be hospitalized for PK analysis during cycle 1 \n\n Life expectancy of at least 12 weeks from the first dose of study treatment) \n\n Randomized Part \n\n Subjects eligible for enrollment in the Randomized Part of the study must meet all of the following criteria: \n\n Signed informed consent \n\n Male or female; \u2265 20 years (at the time of giving consent) \n\n Histologically or cytologically confirmed gastric carcinoma with documented amplification of ErbB2 by fluorescence in situ hybridization (FISH) in primary or metastatic tumor tissue \n\n Subjects who received one prior regimen for gastric carcinoma and defined as progression disease. The regimen must be containing 5-fluoropyrimidine and/or cisplatin \n\n Measurable lesion(s) according to RECIST (Response Evaluation Criteria in Solid Tumors) \n\n Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by echocardiogram. MUGA scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive (LVEF of \u226550% required if normal range of LVEF is not provided by institution) \n\n ECOG Performance Status of 0 to 1 \n\n Able to swallow and retain oral medication \n\n Archived (or Biopsy ) tumor tissue available for FISH testing [Wolff, 2007] in central laboratory \n\n Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study \n\n Washout period from the prior last therapy as follows; Chemotherapy (except for agents below) 4 weeks (IV) Chemotherapy (except for agents below) 2 weeks (P.O) Trastuzumab, Bevacizumab 4 weeks Mitomycin-C, nitrosourea 6 weeks Radiotherapy, Immunotherapy, Biologic therapy and Surgery (except for minor surgical procedure) 2 weeks \n\n Willing to complete all screening assessments as outlined in the protocol \n\n Adequate organ function as defined in Table 2 \n\n Gastrectomy status depending on the result in the Pilot Part \n\n Life expectancy of at least 12 weeks from the first dose of study treatment \n\n Table 2 Baseline Laboratory Values \n\n SYSTEM LABORATORY (VALUES) \n\n Hematologic: \n\n ANC (absolute neutrophil count) \n\n Hemoglobin: \n\n Platelets (\u2265 2.0 \u00d7 10^9/L) (\u2265 9 g/dL) (\u2265 100 \u00d7 10^9/L) Hepatic Albumin Serum bilirubin AST and ALT (\u2265 2.5 g/dL) (\u2264 1.25 x ULN) (\u2264 2.5 \u00d7 ULN without liver metastases) (\u2264 5 \u00d7 ULN if documented liver metastases) Renal Serum Creatinine \n\n Calculate Creatinine Clearance (see Section 11.3) (\u2264 2.0 mg/dL) \n\n - OR - (\u226530 mL/min) \n\n ", - "exclusion_criteria": ": \n\n Subjects meeting any of the following criteria must not be enrolled in the study: \n\n Pregnant or lactating female at anytime during the study \n\n Planned concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, hormonal therapy) while taking investigational treatment \n\n Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2) \n\n Peripheral neuropathy of Grade 2 or greater \n\n Malabsorption syndrome, disease significantly affecting gastrointestinal function. Subjects with ulcerative colitis and Crohn's disease are also excluded \n\n History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible \n\n Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety \n\n Life threatening infection \n\n Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent \n\n Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure \n\n Known history or clinical evidence of central nervous system (CNS) metastasis \n\n Concurrent treatment with prohibited medications, including herbal remedies and Chinese traditional medicines \n\n Concurrent treatment with an investigational agent within 28 days prior to the administration of paclitaxel and/or lapatinib \n\n Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to paclitaxel, including polyethoxylated castor oil, alcohol, or lapatinib or their excipients \n\n Anamnesis or diagnosis of pulmonary disorder, such as interstitial pneumonia, pulmonary fibrosis or serious hypoxia \n\n Gastrectomy surgery if Pilot Part of the study determines that partial gastrectomy (pylorus spared) or total/partial gastrectomy (pylorus removed) has a significant negative impact upon lapatinib PK and safety profile \n\n Known history of use of any EGFR agent (except Trastuzumab) \n\n Prior gastric cancer treatment which included a taxane.", - "brief_summary": "EGF104578 is two-part study (Pilot part/Randomized part).Pilot part is designed to find the optimal (best) doses of lapatinib and paclitaxel when given together,Randomized part is designed to evaluate the overall survival in patients receiving lapatinib and paclitaxel compared to patients receiving only paclitaxel.", - "NCTID": "NCT00486954" - }, - { - "brief_title": "Very Low Density Lipoprotein Turnover in Young and Elderly Individuals", - "phase": "", - "drugs": "['Stable Isotope Infusion']", - "drugs_list": [ - "Stable Isotope Infusion" - ], - "diseases": "['Aging']", - "diseases_list": [ - "Aging" - ], - "enrollment": "24.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 to 35 years, or 60 to 75 years. \n\n Body mass index \u2264 27 kg\u2022m2 \n\n Ability to sign informed consent. \n\n Score of \u226526 for Mini-Mental State Exam \n\n ", - "exclusion_criteria": ": \n\n Diabetics (plasma glucose concentration >200 mg/dl at 2 hr after oral intake of 75 g glucose). \n\n Fasting plasma triacylglycerol concentration above 500 mg/dl \n\n Kidney disease. \n\n Liver disease. \n\n Bleeding disorders. \n\n Anaemia (Hb < 13 g/dl in males or < 12 g/dl in females). \n\n Endocrine disease (with the exception of well-regulated hypothyroidism). \n\n Positive hepatitis or HIV screens. \n\n Alcohol (CAGE questionnaire; abnormal liver enzyme values) or drug abuse (amphetamines, cocaine, opioids, marijuana). \n\n Lipid altering agents. \n\n Score of <26 for Mini-Mental State Exam", - "brief_summary": "Intrahepatic and intramyocellular lipid concentrations are elevated in elderly individuals relative to young people, despite no significant difference in fasting plasma TAG concentrations. Our general hypothesis is that the increase in intrahepatic fat with age results from reduced VLDL turnover, and therefore elderly individuals in this study will display lower VLDL turnover rates than young individuals. The aims of this study are a) to compare VLDL turnover in young and elderly individuals, and b) to compare a bolus method and a constant infusion method of assessing VLDL turnover.", - "NCTID": "NCT02113215" - }, - { - "brief_title": "Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia", - "phase": "", - "drugs": "['thyroxine']", - "drugs_list": [ - "thyroxine" - ], - "diseases": "['Hypothyroxinemia']", - "diseases_list": [ - "Hypothyroxinemia" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Birth weight: less than 1500g \n\n Gestation: 22 weeks 0 day \u2264 \n\n Serum free thyroxine level lower than 0.8 ng/dl \n\n Serum thyrotropin lower than 10 \u03bcU/ml \n\n Age of between 2 and 4 weeks after birth \n\n Informed consent \n\n ", - "exclusion_criteria": ": \n\n any known thyroid disease in mother", - "brief_summary": "In order to determine the efficacy and safety of thyroxine replacement, a randomized clinical trial of thyroxine supplementation for VLBW infant with hypothyroxinemia during the first month of age is conducted.", - "NCTID": "NCT00565890" - }, - { - "brief_title": "A Study of Lenalidomide Versus Placebo in Subjects With Transfusion Dependent Anemia in Lower Risk Myelodysplastic Syndrome (MDS) Without Del 5q", - "phase": "Phase 3", - "drugs": "['Lenalidomide', 'Placebo']", - "drugs_list": [ - "Lenalidomide", - "Placebo" - ], - "diseases": "['Anemia']", - "diseases_list": [ - "Anemia" - ], - "enrollment": "239.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years or older \n\n Diagnosis of low or intermediate-1 risk Myelodysplastic (MDS) with any chromosome karyotype except del 5q[31] \n\n Anemia that requires red blood cell transfusions \n\n Resistant to erythropoiesis stimulating agents (ESAs) or blood erythropoietin level > 500 mU/mL \n\n Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) \u2264 2 \n\n Must agree to follow pregnancy precautions as required by the protocol. \n\n Must agree to receive counseling related to teratogenic and other risks of lenalidomide \n\n Must agree not to donate blood or semen \n\n Must be willing to consent to two or more bone marrow aspirate procedures to be completed during study \n\n ", - "exclusion_criteria": ": \n\n Subjects previously receiving immunomodulating or immunosuppressive agents, or epigenetic or deoxyribonucleic acid (DNA) modulation agents \n\n Allergic reaction to thalidomide \n\n Renal insufficiency creatinine clearance (CrC1)<40 mL/min by Cockcroft-Gault method) \n\n Prior history of cancer, other than MDS, unless the subject has been free of the disease for \u2265 5 years. (Basal cell carcinoma of the skin, carcinoma in situ of the cervix, or stage Tumor (T) 1a or T1b prostate cancer is allowed) \n\n Absolute neutrophil count (ANC) < 500/uL \n\n Platelets < 50,000/uL \n\n Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3X upper limit of normal \n\n Uncontrolled hyperthyroidism or hypothyroidism \n\n Significant neuropathy \n\n Prior stem cell transplantation \n\n Anemia due to reasons other than MDS \n\n History of deep venous thrombosis (DVT) or pulmonary embolus (PE) within past 3 years \n\n Significant active cardiac disease within the past 6 months \n\n Known Human Immunodeficiency Virus (HIV) infection; known Hepatitis C infection or active Hepatitis B infection", - "brief_summary": "The purpose of this study is to investigate whether lenalidomide would reduce the number of red blood cell transfusions (RBC) needed in anemic (RBC transfusion-dependent) participants with low or intermediate-1 risk MDS without a deletion 5q chromosome abnormality. The study also investigated the safety of lenalidomide use in these participants. Two-thirds of the participants received oral lenalidomide and one-third of the participants received oral placebo.", - "NCTID": "NCT01029262" - }, - { - "brief_title": "The Using of NEurocryostimulation in Military Ankle Sprains", - "phase": "", - "drugs": "['neurocryostimulation with Duo-cryo\u00ae device', 'cryotherapy with Cold pack\u00ae or ice-cubes pack']", - "drugs_list": [ - "neurocryostimulation with Duo-cryo\u00ae device", - "cryotherapy with Cold pack\u00ae or ice-cubes pack" - ], - "diseases": "['Sprain of Lateral Ligament of Ankle Joint']", - "diseases_list": [ - "Sprain of Lateral Ligament of Ankle Joint" - ], - "enrollment": "190.0", - "inclusion_criteria": "inclusion criteria: \n\n age equal or less than 40 years-old, military subject, acute ankle injury, To have completed and signed the informed consent. \n\n ", - "exclusion_criteria": ": \n\n contraindications to cryotherapy ( cold allergy, cryoglobulinemia, Raynaud's phenomenon, cutaneous sensory abnormalities, and diabetes mellitus), paracetamol allergy, 4th grade sprains according to the Trevino Classification (with bone wrenching), to take analgesic or anti-inflammatory treatment other than paracetamol.", - "brief_summary": "Introduction: The military population is at high-risk for injury with by painful sprains, especially of the ankle. The referenced treatment method for pain is the cryotherapy, consisting in applying cold-packs to the injured ankle several times a day. However, another pain treatment has been developed and is commonly used by high-level sports teams and rheumatologists but its efficacy has never been assessed within a military population, i.e. the hyperbaric CO2 cryotherapy, also called the neurocryostimulation.~Research design: This study was carried out on a French multicenter basis, the study consisting in a randomized controlled superiority trial and open-label prospective analysis in the treatment of 40-year-old military patients or younger suffering from acute ankle sprains. Two groups were made: patients were treated either by neurocryostimulation or by the referenced cryotherapy (cold-packs). The care protocol for both groups consisted in six supervised 30 minute-sessions within a period of three consecutive days.~Hypothesis: Neurocryostimulation is more effective in the treatment of pain severity resulting from an ankle sprain than the referenced treatment by cold-packs. Moreover, we theorized that the total consumption of paracetamol and the number of days of temporary inaptitude and of work exemption were lower in patients treated by neurocryostimulation.~Outcomes:~For each session, pain severity is assessed on a 100-mm Visual Analog Scale at the beginning and at the end of session 20 minutes later after a four-step walk.", - "NCTID": "NCT01716871" - }, - { - "brief_title": "A Study to Evaluate the Effects of a Natural Supplement in Adults With Chronic Functional Constipation", - "phase": "Phase 2; Phase 3", - "drugs": "['Natural Fibre Supplement']", - "drugs_list": [ - "Natural Fibre Supplement" - ], - "diseases": "['Constipation']", - "diseases_list": [ - "Constipation" - ], - "enrollment": "70.0", - "inclusion_criteria": "inclusion criteria: \n\n To be considered eligible for enrolment into the study, subjects must; \n\n Be able to give written informed consent, \n\n Be between 18 and 80 years of age, \n\n Subject has chronic functional constipation according to the Rome III Diagnostic Criteria, where (f) is mandatory. \n\n i. Must include two or more of the following: \n\n Straining during at least 25% of def\u00e6cations \n\n Lumpy or hard stools in at least 25% of def\u00e6cations \n\n Sensation of incomplete evacuation for at least 25% of def\u00e6cations \n\n Sensation of anorectal obstruction / blockage for at least 25% of defaecations \n\n Manual man\u0153uvers to facilitate at least 25% of def\u00e6cations (e.g., digital evacuation, support of the pelvic floor) \n\n Fewer than 3 def\u00e6cations per week ii. Loose stools are rarely present without the use of laxatives iii. Insufficient criteria for irritable bowel syndrome * Criteria fulfilled for the last 3 months, with symptom onset at least 6 months prior to diagnosis \n\n Subjects will continue on his/her normal diet, \n\n The subject agrees to complete the Patient Diary for two weeks prior to study entry and for the duration of the study. \n\n ", - "exclusion_criteria": ": \n\n Subjects will be excluded from the study if they meet any of the below criteria; \n\n Are less than 18 and greater than 80 years of age, \n\n Females are pregnant, lactating or wish to become pregnant during the study. \n\n Are hypersensitive to any of the components of the test product, \n\n Have a significant acute or chronic, unstable and untreated disease or any condition which contraindicates, in the investigators judgement, entry to the study, \n\n Subject has an obstructive or metabolic aetiology for constipation, \n\n Subject has a history of laxative abuse (greater than the daily dosage recommended on the label for any laxative), \n\n Subject has used a probiotic or prebiotic product or a dietary fibre supplement in the 4 weeks prior to the baseline visit, \n\n Subject has a history of drug and/or alcohol abuse at the time of enrolment \n\n Having a condition or have taken a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; \n\n Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial, \n\n Subjects may not be receiving treatment involving experimental drugs, \n\n If the subject has been in a recent experimental trial, these must have been completed not less than 90 days prior to this study. \n\n Have a malignant disease or any concomitant end-stage organ disease", - "brief_summary": "Constipation is common in the general population, especially in women and in the elderly. Hard stool is a complaint often associated with constipation, which suggests that stool softening would provide a major benefit in the strategy of treatment.~This investigative fibre product is primarily a soluble dietary fibre with added probiotics and a prebiotic. It is not digested in the small intestine and partly remains undigested by bacteria in the gut. Also, as probiotics are believed to help restore a healthy gut flora, reduce pH, assist with digestion of food and reduce gaseous by-products they may aid the improvement of intestinal motility.~The objective of this study is to assess if this investigative, fibre product effects the number of bowel movements per week and if this in turn impacts quality of life and symptoms of constipation.", - "NCTID": "NCT02073006" - }, - { - "brief_title": "Domperidone in Secondary Progressive Multiple Sclerosis (SPMS)", - "phase": "Phase 2", - "drugs": "['Domperidone']", - "drugs_list": [ - "Domperidone" - ], - "diseases": "['Multiple Sclerosis, Secondary Progressive']", - "diseases_list": [ - "Multiple Sclerosis", - "Secondary Progressive" - ], - "enrollment": "64.0", - "inclusion_criteria": "inclusion criteria: \n\n written informed consent obtained \n\n with Multiple Sclerosis, and with secondary progressive disease course \n\n screening Expanded Disability Status Scale (EDSS) score between 4.0 and 6.5 inclusive \n\n screening timed 25 foot walk (average of two trials) lof 9 seconds or more \n\n ", - "exclusion_criteria": ": \n\n Long QT interval, defined as corrected QT interval of more than 470 msec in men and more than 450 msec in women on baseline ECG \n\n Patients with known long-QT syndrome \n\n Patients with known ventricular arrhythmia \n\n Patients with a known electrolyte disturbance \n\n Patients undergoing treatment with drugs that increase the QTc interval \n\n Patients undergoing treatment with drugs that inhibit CYP3A4, in particular: Ketoconazole, Fluconazole, Erythromycin, Clarithromycin, Ritonavir \n\n Patients with a history of breast cancer or carcinoma in situ \n\n Patients with known renal insufficiency \n\n Patients with known allergy or other intolerability to domperidone \n\n Patients currently using Fampridine or 4-aminopyridine \n\n Patients planning to start Fampridine or 4-aminopyridine during the study period \n\n Patients planning to start Baclofen or Tizanidine during the duration of the study \n\n Patients planning to increase or decrease their dose of Baclofen or Tizanidine during the study period \n\n Patients planning to receive treatment with Botulinum toxin in the leg muscles during the duration of the study \n\n Patients with a significiant hepatic impairment \n\n Patients with a prolactinoma \n\n Patients in whom gastrointestinal stimulation could be dangerous \n\n Patients using MAO inhibitors \n\n Patients with a history of breast cancer \n\n Pregnant or breast-feeding women", - "brief_summary": "The purpose of this clinical trial is to determine if Domperidone in a dose of 40 mg daily can prevent worsening of walking ability in people secondary progressive MS. The number of participants in this study will be 62. A maximum of 75 people with secondary progressive MS will be included. Each patient will be followed for 12 months from inclusion. Domperidone is a medication which has been shown to increase levels of the hormone prolactin. The best understood function of prolactin is the stimulation of milk production in women after delivery. However, the increase in prolactin levels seen in patients treated with standard doses of Domperidone (in doses of up to 80mg per day) usually does not lead to clinical symptoms. Prolactin has been shown to improve myelin repair in mice. Domperidone therefore may also improve myelin repair in people with MS. Domperidone is currently approved in Canada to treat slow moving bowels and nausea, for instance in patients with Parkinson's Disease or Diabetes Mellitus, where too slowly moving bowels can cause constipation. Domperidone is available as a tablet that is usually taken four times per day. Doses up to 80mg per day may be used but we estimate that a dose of only 40mg daily will be needed to stimulate myelin repair. Domperidone is usually well tolerated.", - "NCTID": "NCT02308137" - }, - { - "brief_title": "Effects of Antipsychotic Medications on Energy Intake and Expenditure", - "phase": "", - "drugs": "['H218O and 2H2O, administered as a mixed cocktail']", - "drugs_list": [ - "H218O and 2H2O", - "administered as a mixed cocktail" - ], - "diseases": "['Schizophrenia', 'Schizoaffective Disorder', 'Weight Gain']", - "diseases_list": [ - "Schizophrenia", - "Schizoaffective Disorder", - "Weight Gain" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria: \n\n non-diabetic \n\n schizophrenic or schizoaffective \n\n currently prescribed olanzapine or ziprasidone \n\n 18-80 y.o. \n\n ", - "exclusion_criteria": ": \n\n <18 or >80 years of age \n\n diabetic \n\n not schizophrenic or schizoaffective \n\n not currently prescribed olanzapine or ziprasidone", - "brief_summary": "Aim 1: To evaluate the effect of antipsychotic treatment group on Activity Energy Expenditure. The project hypothesizes that subjects treated with olanzapine will demonstrate a greater decrease in AEE over time than subjects treated with ziprasidone, due at least in part to sedating effects of olanzapine.~Aim 2: To evaluate the effect of antipsychotic treatment group on Energy Intake. The project hypothesizes that subjects treated with olanzapine will demonstrate a greater increase in EI over time than subjects treated with ziprasidone, based on higher histamine type 1 (H1) receptor affinity of olanzapine and the relationship between H1 affinity and hunger and/or satiety.", - "NCTID": "NCT00836251" - }, - { - "brief_title": "Study to Assess Safety of an Inactivated H5N1 Influenza Vaccine Administered in GelVac Nasal Powder to Healthy Young Adults", - "phase": "Phase 1", - "drugs": "['GelVac\u2122 nasal powder H5N1 influenza vaccine.', 'Placebo']", - "drugs_list": [ - "GelVac\u2122 nasal powder H5N1 influenza vaccine.", - "Placebo" - ], - "diseases": "['Phase 1 Safety Study of GelVac Nasal Powder H5N1 Influenza Vaccine']", - "diseases_list": [ - "Phase 1 Safety Study of GelVac Nasal Powder H5N1 Influenza Vaccine" - ], - "enrollment": "7.0", - "inclusion_criteria": "inclusion criteria: \n\n able to read and sign Informed Consent Form (ICF). \n\n male or female > 18 and < 49 years of age at the time the ICF is signed. \n\n generally healthy, as determined by medical history and clinical assessment. \n\n able to attend all scheduled visits and to comply with all trial procedures. \n\n if female of child-bearing potential, use of an acceptable method of contraception or abstinence for at least 4 weeks prior to the first vaccination through at least four weeks after the second vaccination. Acceptable methods are hormonal birth control or a barrier method with spermicide. \n\n if female, post menopausal (no menstrual period within the last 12 months), surgically sterile (hysterectomy or tubal ligation), or have a negative urine pregnancy test within 24 hours prior to the time of vaccination. \n\n ", - "exclusion_criteria": ": \n\n has a known allergy to fruits (e.g., apples, oranges) or pectin and/or pectin by-products (including jams or jellies). \n\n has a known allergy to dairy/milk products/lactose. \n\n is breast-feeding or pregnant or planning on becoming pregnant within 1 month of vaccination. \n\n has a history of a chronic viral infection (i.e.; Shingles, Herpes Zoster, HIV). \n\n has a history of severe allergic reaction following influenza vaccination, systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing the same substances. \n\n has a history of demyelinating disease (esp. Guillian-Barre Syndrome). \n\n history of Bell's Palsy. \n\n immunosuppression as a result of underlying illness or treatment. \n\n use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 \u00b5g/day of beclomethasone dipropionate or equivalent) within 1 month prior to vaccination. \n\n use of other immunosuppressive or cytotoxic drugs or radiation therapy within six months prior to vaccination. \n\n use of OTC or other 'herbal' immune suppressant or stimulants within the 6 months prior to vaccination. \n\n active neoplastic disease or history of any hematologic malignancy in the past 5 years (except localized skin or prostate cancer that is stable in the absence of therapy). \n\n acute or chronic condition that (in the opinion of the Investigator) would render vaccination unsafe or would interfere with the evaluation of responses including, but not limited to the following: known chronic liver disease, significant renal disease, oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV, unstable or progressive neurologic disorder, insulin-treated diabetes mellitus, and asthma. \n\n use of experimental vaccines within 6 months prior to study entry, or expected use of experimental vaccines during the entire study period after inoculation with study vaccine. \n\n participation in another clinical trial 30 days prior to study entry. \n\n use of experimental devices or participation in a medical procedure trial within the month prior to study entry, or expected use of experimental devices or participation in a medical procedure trial during the entire study period. \n\n receipt of immunoglobulin or other blood product within 3 months prior to enrollment. \n\n receipt of other licensed vaccines within the preceding 6 months or expected to receive a licensed vaccine within 28 days following last trial vaccination. \n\n subject is enrolled in a conflicting clinical trial. \n\n any disorder or therapy contraindicating influenza vaccination. \n\n Have a clinically significant structural abnormality of the nasopharynx (e.g., obvious deviation that obstructs airflow in either nostril), as determined by the investigator \n\n acute respiratory disease at the time of enrollment. \n\n febrile illness with temperature greater than or equal to 38 degrees Celsius (100.4 degrees F) within 72 hours prior to enrollment. \n\n receipt of allergy shots within the preceding 7 days or expected to receive allergy shots within 7 days following vaccination. \n\n any condition that, in the opinion of the investigator, would pose a health risk to the participant. \n\n presence of any active disease or condition at the administration site that, in the opinion of the Investigator, would impact vaccine delivery or assessment of vaccination site. \n\n history of drug abuse or alcohol abuse in the five years prior to enrollment. Subject who abuses alcohol or other drugs of abuse.", - "brief_summary": "This is a double-blind, placebo controlled, safety and immunogenicity study of GelVac\u2122 nasal powder H5N1 influenza vaccine. Healthy male and female subjects between 18 and 49 years of age who are eligible for study participation will be enrolled in the trial. It is expected that 10 subjects will be screened to obtain 7 subjects who will be eligible for study participation.~The primary objective is to determine the frequency and severity of local and systemic adverse events of vaccine.~The secondary objective is to assess the immunogenicity of the vaccine based on geometric mean titers (GMT) of serum HAI, serum neutralizing, and nasal wash IgA antibodies.", - "NCTID": "NCT01258062" - }, - { - "brief_title": "The Effect of Administration of Small Doses of Thyroxine on Glucose and Lipid Metabolism, in Type 2 Diabetes Mellitus.", - "phase": "", - "drugs": "['thyroxine', 'Placebo', 'A meal (730kcal, 50%carbohydrate, of which 38% was starch, 40% fat, and 10% protein)']", - "drugs_list": [ - "thyroxine", - "Placebo", - "A meal (730kcal", - "50%carbohydrate", - "of which 38% was starch", - "40% fat", - "and 10% protein)" - ], - "diseases": "['Diabetes Mellitus']", - "diseases_list": [ - "Diabetes Mellitus" - ], - "enrollment": "33.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy or treatment naive type 2 diabetes euthyroid subjects, with a micronodular texture of the thyroid gland. \n\n Recreationally active \n\n With stable body weight and diet during the last two months. \n\n ", - "exclusion_criteria": ": \n\n Any systemic disease(besides glucose abnormalities) \n\n Any medication therapy \n\n Diabetic complications", - "brief_summary": "We investigated the effect of the administration of small doses of thyroxine to healthy humans and patients with type 2 diabetes on postprandial forearm muscle glucose uptake, insulin sensitivity indices, lipid metabolism, in vitro glucose uptake and GLUT4 recruitment in the plasma membrane of monocytes.", - "NCTID": "NCT02509858" - }, - { - "brief_title": "Efficacy of T1675 Versus Placebo in Patients With Bilateral Treated Moderate Dry Eye Syndrome", - "phase": "Phase 2", - "drugs": "['Food supplement (T1675)']", - "drugs_list": [ - "Food supplement (T1675)" - ], - "diseases": "['Dry Eye Syndromes']", - "diseases_list": [ - "Dry Eye Syndromes" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Signed and dated informed consent. \n\n Male or female aged from 18 to 90 years old. \n\n Known treated bilateral dry eye. \n\n Dry eye syndrome confirmed by ocular examination with a fluorescein and/or lissamine green staining, BUT and Schirmer, performed within the last 12 months before Inclusion Visit, for both eyes. \n\n Bilateral symptomatology suggestive of dry eye defined by: at least one of the following ocular symptoms suggestive of dry eye (burning, stinging, dryness feeling, sandy and/or gritty sensation, light sensitivity, reflex tearing, ocular fatigue) and Questioning on patient's feeling (score >=3). \n\n Fulfilling the following criteria of dry eye syndrome in both eyes defined by: Keratoconjunctivitis defined by a lissamine green score \u2265 4 (Van Bijsterveld score) and Schirmer test <= 10 mm in 5 min or BUT < 10 s \n\n ", - "exclusion_criteria": ": \n\n severe dry eye symptom \n\n eyelid dysfunction \n\n severe progressive rosacea \n\n any relevant ocular anomaly interfering with ocular surface \n\n best corrected far visual acuity <= 1/10 \n\n history of ocular allergy \n\n traumatism, infection, inflammation within last 3 months \n\n ocular surgery and laser within the last 3 months \n\n lasik, laser, PKR within the last 12 months \n\n contact lenses \n\n any concomitant nutritive supplementation, vitamins \n\n any topical concomitant treatment", - "brief_summary": "To evaluate the efficacy of a 6-month (\u00b1 14 days) dietary supplementation period with T1675, a per os omega 3 and omega 6 polyunsaturated essential fatty acid dietary formulation, versus placebo in patients with bilateral treated moderate dry eye syndrome", - "NCTID": "NCT00357201" - }, - { - "brief_title": "Thyroid Hormones Treatment in Asthma Exacerbation", - "phase": "", - "drugs": "['IV thyroxin', 'Placebo']", - "drugs_list": [ - "IV thyroxin", - "Placebo" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years of age or older \n\n Known Asthma \n\n The exacerbation is defined as moderate or severe. \n\n Not currently enrolled as an active participant in another clinical trial of a medical therapy or device. \n\n The patient or first degree family relative (in cases where the patient is intubated) has authorized his/her consent to participate in this trial. The patient will be asked to give his consent only after initial bronchodilator therapy \n\n ", - "exclusion_criteria": ": \n\n 60 years of age or older \n\n Known thyroid disorders \n\n Subject where thyrotoxicosis is suspected \n\n Known heart disease \n\n Heart rate > 140", - "brief_summary": "This study will explore whether supplementation with thyroid hormones in the set-up of asthma exacerbation could improve the clinical outcomes.~The study will include adults admitted to Rambam health care campus for moderate to severe Asthma exacerbation.~The study is a prospective, randomized, double-blind, placebo-controlled, clinical trial. Patients will be randomized on admission to receive treatment with intra-venous thyroxine (100mcg once on admission and additional 100mcg after 12 hours) or placebo. The study treatment will be given only after the initial bronchodilator therapy, oxygen and informed consent are given. The primary endpoint is the time to return of the peak expiratory flow (PEF) rate to normal values or personal base line.", - "NCTID": "NCT02086799" - }, - { - "brief_title": "Thermoregulation in the Preterm Infant", - "phase": "", - "drugs": "['Polyethylene for thermoregulation in the preterm infant']", - "drugs_list": [ - "Polyethylene for thermoregulation in the preterm infant" - ], - "diseases": "['Nursing Care']", - "diseases_list": [ - "Nursing Care" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria: \n\n Preterm Infant were included according with the Official Mexican Norm -007-SSA2-1993 (1995) \n\n ", - "exclusion_criteria": ": \n\n Preterm Infant were not included in case of malformations that involved lost of the cutaneous integrity or in case of severe cardiac congenital disease.", - "brief_summary": "The purpose of this study is to compare the response of temperature adaptation in preterm infant using the polyethylene wrap with and without previous drying.", - "NCTID": "NCT01236599" - } - ], - "1": [ - { - "brief_title": "Metabolic Changes in Hypothyroid Patients", - "phase": "", - "drugs": "['L-thyroxine']", - "drugs_list": [ - "L-thyroxine" - ], - "diseases": "['Hypothyroidism']", - "diseases_list": [ - "Hypothyroidism" - ], - "enrollment": "22.0", - "inclusion_criteria": "inclusion criteria: \n\n Newly diagnosed hypothyroidism with tsh over 40 mU/L, etiology chronic autoimmune thyroiditis \n\n Healthy controls matched regarding sex, age and body mass index \n\n ", - "exclusion_criteria": ": \n\n Pregnancy, breastfeeding", - "brief_summary": "Hypothyroidism is a frequent condition in danish women, but often overlooked. Along with fatigue one of the main symptoms is weight gain as a result to significantly decreased energy expenditure.~This study was undertaken to elucidate changes in glucose, lipid and amino acid turnover in these patients.", - "NCTID": "NCT00524238" - }, - { - "brief_title": "Central Hypothyroidism and Cardiovascular Risk", - "phase": "", - "drugs": "['levothyroxine']", - "drugs_list": [ - "levothyroxine" - ], - "diseases": "['Hypopituitarism']", - "diseases_list": [ - "Hypopituitarism" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients with pituitary hypopituitarism \n\n ", - "exclusion_criteria": ": \n\n Unavailability of data", - "brief_summary": "Retrospective trial of 300 patients with pituitary insufficiency treated in Department of Medica Endocrinology, Rigshospitalet, Copenhagen University concerning levothyroxine (T4) replacement and cardiovascular risk factors. The hypothesis is that subtle central hypothyroidism is associated with adverse cardiac risk factors, such as body composition and serum lipids, and that improved T4 replacement will eliminate this increased risk, independently of other pituitary hormone replacements.", - "NCTID": "NCT01574859" - }, - { - "brief_title": "Effects of L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Hypothyroidism", - "phase": "Phase 4", - "drugs": "['L-thyroxine']", - "drugs_list": [ - "L-thyroxine" - ], - "diseases": "['Hypothyroidism', 'Thyroid Diseases', 'Endocrine System Diseases']", - "diseases_list": [ - "Hypothyroidism", - "Thyroid Diseases", - "Endocrine System Diseases" - ], - "enrollment": "700.0", - "inclusion_criteria": "inclusion criteria: \n\n 40 \n\n 75 years old \n\n Diagnosis of overt or subclinical hypothyroidism in two occasions with a minimum interval period of three months \n\n ", - "exclusion_criteria": ": \n\n Pregnant or lactating women \n\n Severe hepatic or renal dysfunction \n\n Psychiatric disabilities, acute cardiovascular and cerebrovascular diseases, chronic respiratory diseases, familiar hypercholesterolemia, malignancy, cholelithiasis, pancreatitis, bowel diseases and other disorders influencing lipid and bile acid metabolism \n\n Taking lipid-lowering agents and other drugs influencing thyroid function, lipid and bile acid metabolism \n\n Obviously poor compliance.", - "brief_summary": "Hypothyroidism is a common clinical entity which is often complicated by dyslipidemia. It is also reported increased risk for incidence of atherosclerosis and resulting coronary heart disease(CHD), heart failure(HF) and cardiovascular(CV) death. The effect of L-thyroxine replacement treatment on serum lipid and atherosclerosis is controversial in hypothyroid patients, especially in those with mild or moderate subclinical hypothyroidism. The present study was designed to investigate whether L-thyroxine replacement was effective in improving serum lipid profiles and retarding atherosclerosis progress.~Studies have shown that hypothyroidism increased the risk of COVID-19 composite poor outcomes. This study also aimed to investigate whether L-thyroxine replacement therapy was effective in reducing the incidence and mortality of COVID-19, and in improving the severity of COVID-19 and COVID-19 related complications.", - "NCTID": "NCT01848171" - }, - { - "brief_title": "TG Gene Mutations and Congenital Hypothyroidism", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Congenital Hypothyroidism']", - "diseases_list": [ - "Congenital Hypothyroidism" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Patients with congenital hypothyroidism due to thyroglobulin defective synthesis. \n\n ", - "exclusion_criteria": ": \n\n Patients with another disease.", - "brief_summary": "The aim of this study was to identify mutations in the thyroglobulin gene that might be present in patients with fetal goiter and congenital goiter hypothyroidism.", - "NCTID": "NCT00493103" - }, - { - "brief_title": "Osteopathy and Latent Hypothyroidism", - "phase": "", - "drugs": "['OMT']", - "drugs_list": [ - "OMT" - ], - "diseases": "['Latent Hypothyroidism']", - "diseases_list": [ - "Latent Hypothyroidism" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n latent hypothyroidism \n\n ", - "exclusion_criteria": ": \n\n Factors that Alter Thyroxine and Triiodothyronine Binding in Serum \n\n Increased thyroxin-binding globulin \n\n Decreased thyroxin-binding globulin \n\n Binding inhibitors \n\n Inherited Salicylates \n\n Pregnancy \n\n Androgens \n\n Furosemide \n\n Neonatal state \n\n Anabolic steroids \n\n Free fatty acids \n\n Estrogens \n\n Glucocorticoids \n\n Phenytoin \n\n Hepatitis \n\n Severe illness \n\n Carbamazepine \n\n Porphyria \n\n Hepatic failure \n\n nonsteroidal antiinflammatory drug (variable, transient) \n\n Heroin \n\n Nephrosis \n\n Heparin \n\n Methadone \n\n Nicotinic acid \n\n Mitotane L-Asparaginase \n\n 5-Fluorouracil \n\n SERMS (e.g., tamoxifen, raloxifene) \n\n Perphenazine \n\n spinal pathologies", - "brief_summary": "This study evaluates the effectiveness of stimulating the neurological segments c8-th5 in patients with latent hypothyroidism.~One half of the participants will receive an osteopathic manuel treatment in order to stimulate the relevant segments, the other half will receive no treatment.", - "NCTID": "NCT02430857" - }, - { - "brief_title": "Subclinical Hypothyroidism and Mind in the Elderly", - "phase": "Phase 2; Phase 3", - "drugs": "['levothyroxine sodium', 'excipient without levothyroxine (placebo)']", - "drugs_list": [ - "levothyroxine sodium", - "excipient without levothyroxine (placebo)" - ], - "diseases": "['Subclinical Hypothyroidism']", - "diseases_list": [ - "Subclinical Hypothyroidism" - ], - "enrollment": "70.0", - "inclusion_criteria": "inclusion criteria: \n\n TSH between 4 and 10 mUI/L inclusive \n\n ", - "exclusion_criteria": ": \n\n Known and treatment of thyroideal disease \n\n Arrythmia \n\n Anticoagulant treatment \n\n Dementia \n\n Disease leading to dementia (acv, LIVER....)", - "brief_summary": "Some recommendations of expert consensus on subclinical hypothyroidism (SH) are controversial in those areas with not enough information to reach a conclusion, such as not recommending treatment with thyrotrophic hormone of 4-10 mUI/L and free thyroxin in normal range. The body changes or symptoms at this stage are often mistaken as aging. There are studies showing significant changes in heart (slow rate, lower ejection fraction, diastolic dysfunction); hypercholesterolemia, dysfunction cognitive abilities (memory attention\u2026).~The prevalence of SH increases with age, reaching 14% over 65 years old. This age group increase as the population ages highlights the need for evidence to improve recommendations for the elderly.~NEUROPSI is a validated neuropsychological test sensible for mild cognitive alterations. It can be applied to individuals with little schooling.~This study aims to determine positive change in cognitive abilities (NEUROPSI), ejection fraction, and body percent of lean and adipose tissue without adverse effects, placebo versus thyroxin supplement to keep thyroid-stimulating hormone (TSH) between 0.5-2.5 mUI/L in elderly with TSH 4-10 mIU/L.", - "NCTID": "NCT00921050" - }, - { - "brief_title": "Levothyroxine Treatment in Thyroid Benign Nodular Goiter", - "phase": "", - "drugs": "['Levothyroxin treatment']", - "drugs_list": [ - "Levothyroxin treatment" - ], - "diseases": "['Thyroid Nodule']", - "diseases_list": [ - "Thyroid Nodule" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n age between 20 to 90 years old \n\n Benign nodular goiter diagnosed with thyroid echo and fine-needle - aspiration cytology \n\n ", - "exclusion_criteria": ": \n\n Age younger than 20 or older than 90 years old \n\n Pregnancy \n\n Allergy to eltroxin \n\n Taking other drugs which will have drug interaction with eltroxin \n\n patients with cardiovascular disease, hypertension, gastrointestinal disease", - "brief_summary": "We will study the effect of taking eltroxin at different time, i.e. fasting or postprandial periods. We will also study the effect of levothyroxin treatment in Chinese people", - "NCTID": "NCT00552253" - }, - { - "brief_title": "Method of Endogenous TSH Stimulation in the Follow-up of Differentiated Thyroid Cancer", - "phase": "", - "drugs": "['L-thyroxin']", - "drugs_list": [ - "L-thyroxin" - ], - "diseases": "['Thyroid Cancer']", - "diseases_list": [ - "Thyroid Cancer" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Differentiated thyroid cancer \n\n treated by thyroidectomy and at least 1 ablation with 131-I > 5 months ago \n\n TSH < 4 imU/L \n\n ", - "exclusion_criteria": ": \n\n Pregnancy \n\n Known metastasis", - "brief_summary": "The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine treatment. In the follow-up of patients it is necessary to induce TSH elevation to test for cancer recurrence. One of the options is to stop L-thyroxin replacement for several weeks. Current pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks in majority of patients.", - "NCTID": "NCT01840332" - } - ], - "2": [ - { - "brief_title": "Detection of Celiac Disease in Patients With Hypothyroidism", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Celiac Disease', 'Hypothyroidism', 'Celiac Sprue', 'Malabsorption']", - "diseases_list": [ - "Celiac Disease", - "Hypothyroidism", - "Celiac Sprue", - "Malabsorption" - ], - "enrollment": "500.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with the diagnosis of hypothyroidism that require thyroid replacement therapy. \n\n ", - "exclusion_criteria": ": \n\n Surgical resection of thyroid tissue, neck irradiation, radioactive iodine therapy, prior medical treatment with lithium, methimazole, propylthiouracil, ethionamide, amiodarone, or sunitinib, prior serologic testing for celiac disease.", - "brief_summary": "The study evaluates whether hypothyroid patients requiring elevated doses of levothyroxine to maintain a euthyroid state are at increased risk of having celiac disease. It also attempts to determine if there is a threshold level of levothyroxine needed to maintain a euthyroid state in patients with hypothyroidism that should prompt serologic testing for celiac disease.", - "NCTID": "NCT01862510" - }, - { - "brief_title": "Observational Study With Prospective and/or Retrospective Follow-up, Without Modifying Patient Treatment and Follow-up Practices for the Initial Treatment of Hypothyroidism in France", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Hypothyroidism']", - "diseases_list": [ - "Hypothyroidism" - ], - "enrollment": "1285.0", - "inclusion_criteria": "inclusion criteria: \n\n Recently diagnosed hypothyroid subject (either during the inclusion period, or within the 6 previous months) for whom, data related to the diagnosis is available if the diagnosis was not carried out initially by the investigating doctor \n\n Subject, who has given his/her oral consent for participation \n\n ", - "exclusion_criteria": ": \n\n Subject included in clinical trial or having participated in a clinical trial during the last 3 months \n\n Subject presenting a major and objectifiable risk of not being able to follow-up until the next TSH level (moving, problems encountered during another study, pathology affecting the vital prognosis in the short-term) \n\n All contraindications to L\u00e9vothyrox", - "brief_summary": "This observational survey with prospective and/or retrospective follow-up is designed to study practices for the initial treatment of hypothyroidism in France without modifying subject treatment.", - "NCTID": "NCT01197183" - } - ] - }, - { - "patient_id": "sigir-201512", - "patient": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", - "0": [ - { - "brief_title": "Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice", - "phase": "", - "drugs": "['Head CT Decision Aid']", - "drugs_list": [ - "Head CT Decision Aid" - ], - "diseases": "['Head Injury']", - "diseases_list": [ - "Head Injury" - ], - "enrollment": "971.0", - "inclusion_criteria": "inclusion criteria: \n\n Parents and their child, seeking care for a child who: \n\n Is < 18 years of age; \n\n Had blunt trauma above the eyebrows (not isolated to face or eyes); \n\n Is positive for at least 1 of the PECARN clinical prediction rule predictors described below: \n\n PECARN Predictors for children < 2 years of age: \n\n Severe mechanism (PECARN definition)* Loss of consciousness > 5 seconds Acting abnormally per parent Initial ED GCS < 15 by attending (or CT decision-maker) Other signs of altered mental status (PECARN definition) Presence of occipital, temporal or parietal scalp hematoma Palpable skull fracture or unclear if skull fracture \n\n PECARN predictors for children 2-18 years of age: \n\n Severe mechanism (PECARN definition)* Any loss of consciousness Any vomiting since the injury Severe headache in ED Initial ED GCS < 15 by attending (or CT decision-maker) Other signs of altered mental status (PECARN definition)** Any sign of basilar skull fracture Clinicians include attending physicians and fellows or midlevel providers caring for children with head trauma \n\n ", - "exclusion_criteria": ": \n\n Parents of children with: \n\n GCS scores < 15 \n\n Evidence of penetrating trauma, signs of basilar skull fracture, or depressed skull fracture on physical examination \n\n Brain tumors \n\n Ventricular shunts \n\n Bleeding disorder \n\n Pre-existing neurological disorders complicating assessment \n\n Neuroimaging at an outside hospital before transfer \n\n Signs of altered mental status (agitation, somnolence, repetitive questioning, or slow response to verbal communication) \n\n Syncope or seizure disorder preceded (led to) head trauma or seizure post head trauma \n\n Known to be pregnant \n\n Communication barriers such as visual or hearing impairment that may preclude use of the decision aid. \n\n Strong suspicion of abuse for this head injury", - "brief_summary": "The investigators will test the impact of a decision aid, Head CT Choice, to determine if its use improves parents' knowledge and engagement in decision making and safely decreases healthcare utilization in children presenting to the emergency department with blunt head trauma.", - "NCTID": "NCT02063087" - }, - { - "brief_title": "Spontaneous Intracranial Hypotension Treatment SIHT", - "phase": "", - "drugs": "['24 hours Trendelenburg position', '24 hours bed rest', 'EBP']", - "drugs_list": [ - "24 hours Trendelenburg position", - "24 hours bed rest", - "EBP" - ], - "diseases": "['Spontaneous Intracranial Hypotension']", - "diseases_list": [ - "Spontaneous Intracranial Hypotension" - ], - "enrollment": "64.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years or more \n\n No contraindication for BPE \n\n Severe or moderate headache within 15 min standing, mild or no headache after 15 min bed rest \n\n Headache from 5 to 28 days \n\n Normal or evidence of low CSF on MRI \n\n Signed informed consent \n\n ", - "exclusion_criteria": ": \n\n Known dural leak in the previous 2 months the onset of headache \n\n Abnormal MRI \n\n First BPE for SIH \n\n The patient has participated in another clinical trial than can interact with the evaluation \n\n Contraindication of Trendelenburg position", - "brief_summary": "Spontaneous intracranial hypotension (SIH) is an infrequent disease, related to a leak of cerebrospinal fluid. There are not controlled studies for this treatment.The main of this study is to demonstrate the superiority of the Trendelenburg position compared to supine position during 24 hours after an epidural blood patch for a spontaneous intracranial hypotension", - "NCTID": "NCT02261792" - }, - { - "brief_title": "Is a Two-Film Skull X-ray Series as Sensitive as a Four-Film Series in the Diagnosis of Skull Fractures in Paediatric Patients", - "phase": "", - "drugs": "['4-views series', '2-views serie']", - "drugs_list": [ - "4-views series", - "2-views serie" - ], - "diseases": "['Head Trauma']", - "diseases_list": [ - "Head Trauma" - ], - "enrollment": "14.0", - "inclusion_criteria": "inclusion criteria: \n\n Children who had a radiography for head trauma \n\n ", - "exclusion_criteria": ": \n\n None", - "brief_summary": "Minor head injuries are a common presenting complaint in the pediatric emergency department. Skull x-rays are a useful tool in the evaluation of paediatric patients with a history of minor head trauma. However, there exists ongoing controversy regarding the ideal number of views that should be obtained in a skull series. This study aims to determine if there is a significant difference in the diagnostic accuracy of skull x-rays in the diagnosis of fracture in paediatric minor head trauma patients when a 2-film series as opposed to a 4-film series is provided to participating pediatric emergency physicians.", - "NCTID": "NCT01448473" - }, - { - "brief_title": "Study of Current Practice Evaluating the Efficacy of a Mobile Short Message Service (SMS) on Post-fracture Management.", - "phase": "", - "drugs": "['Use of SMS']", - "drugs_list": [ - "Use of SMS" - ], - "diseases": "['Low Trauma Non Vertebral Fracture']", - "diseases_list": [ - "Low Trauma Non Vertebral Fracture" - ], - "enrollment": "97.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients of more than 50 years old \n\n Low trauma non vertebral fracture \n\n Ambulatory patient \n\n Direct access to mobile phone (or access with the help of a close person) and ability to communicate via SMS. \n\n Patient who doesn't oppose to his participation in the study \n\n Affiliation to the social security \n\n ", - "exclusion_criteria": ": \n\n Patients hospitalized for the fracture in the orthopaedics department because these more severe patients have a systematic screening and management of osteoporosis. \n\n Fractures whose location is not suggestive of osteoporotic fracture (cervical spine, skull, hands, fingers, toes) \n\n Pathological fractures (cancer or myeloma) \n\n Traumatic fractures \n\n Severe alterations of cognitive functions \n\n Resident subjects except Paris and the surrounding area", - "brief_summary": "The purpose of the study is to show that the standardized sending of SMS improve the bone mineral density (BMD) screening of patients seen in the Emergency department for low trauma fracture.", - "NCTID": "NCT01915745" - }, - { - "brief_title": "Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children", - "phase": "Phase 3", - "drugs": "['Lorazepam', 'Lorazepam']", - "drugs_list": [ - "Lorazepam", - "Lorazepam" - ], - "diseases": "['Status Epilepticus', 'Seizures']", - "diseases_list": [ - "Status Epilepticus", - "Seizures" - ], - "enrollment": "140.0", - "inclusion_criteria": "inclusion criteria: \n\n Children presenting convulsing to the pediatric emergency or developing seizure while in casualty \n\n Age 6-14 years \n\n ", - "exclusion_criteria": ": \n\n Known hypersensitivity to any benzodiazepine \n\n Child has received any parenteral anti-convulsant within 1 hr prior to enrollment \n\n Presence of severe cardio-respiratory compromise or cardiac arrhythmias \n\n Presence of upper respiratory tract infection \n\n Presence of basal skull fracture causing cerebro-spinal fluid (CSF) rhinorrhea", - "brief_summary": "Status epilepticus (SE) is a common pediatric emergency which is potentially life-threatening and requires rapid termination. Early and effective treatment is essential to prevent the morbidity and mortality associated with prolonged convulsive SE. Lorazepam is the standard of care for control of SE when administered by intra-venous (IV) route. The investigators intend to compare efficacy and adverse effect profile of intra-nasal vs. intravenous routes of administration of lorazepam. In resource poor settings, sometimes trained personnel or appropriate equipment for intra-venous cannulation is not available. Alternate routes of administration, if shown equivalent to conventional IV route, will be very useful in such settings or for out of hospital management of seizures in children.", - "NCTID": "NCT00735527" - }, - { - "brief_title": "Use of MigraineBoxTM Head and Neck Cooling Bath for Treatment of Primary Headache in the Emergency Department", - "phase": "", - "drugs": "['MigraineBoxTM']", - "drugs_list": [ - "MigraineBoxTM" - ], - "diseases": "['Primary Headache']", - "diseases_list": [ - "Primary Headache" - ], - "enrollment": "29.0", - "inclusion_criteria": "inclusion criteria: \n\n 18-85 years old \n\n Benign headache \n\n Physician intends to treat headache pain in the ED with either droperidol, prochlorperazine, or a parenteral narcotic \n\n ", - "exclusion_criteria": ": \n\n Unable to provide informed consent \n\n Headache due to trauma, subarachnoid hemorrhage, meningitis, intracerebral bleed, cranial tumor, sinusitis, dental pathology, temporomandibular joint dysfunction, glaucoma, or systemic infection \n\n Known renal impairment \n\n Known hepatic impairment \n\n A history of coronary artery disease, peripheral vascular disease, or cerebrovascular disease \n\n Perforated ear drum \n\n Pregnant", - "brief_summary": "MigraineBoxTM is a simple, contoured cooling bath for the head and neck. Effectiveness of MigraineBoxTM will be studied in primary headaches in the emergency department. The user simply reclines his/her head and neck into this device that has contours that support the head and neck. Luke warm water is filled into the MigraineBoxTM before use and then a frozen insert is placed inside. This will gradually cool the water surrounding the patient's head and theoretically provide headache relief.", - "NCTID": "NCT01977001" - }, - { - "brief_title": "Study of Cerebrospinal Fluid Samples in Diagnosing Carcinomatous Meningitis in Patients With Cancer or Meningeal Syndrome", - "phase": "", - "drugs": "['diagnostic laboratory biomarker analysis', 'immunoenzyme technique', 'magnetic resonance imaging']", - "drugs_list": [ - "diagnostic laboratory biomarker analysis", - "immunoenzyme technique", - "magnetic resonance imaging" - ], - "diseases": "['Brain and Central Nervous System Tumors', 'Breast Cancer', 'Metastatic Cancer']", - "diseases_list": [ - "Brain and Central Nervous System Tumors", - "Breast Cancer", - "Metastatic Cancer" - ], - "enrollment": "80.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Meets 1 of the following criteria: \n\n Diagnosis of metastatic breast cancer with evidence suggestive of carcinomatous meningitis, with or without brain metastasis \n\n Other type of cancer with evidence suggestive of carcinomatous meningitis \n\n Meningeal syndrome without context of cancer \n\n PATIENT CHARACTERISTICS: \n\n No other prior cancers \n\n Not pregnant or nursing \n\n PRIOR CONCURRENT THERAPY: \n\n No prior intrathecal treatment \n\n At least 4 weeks since prior interferon \n\n No concurrent participation in another clinical trial", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Studying samples of cerebrospinal fluid from patients with cancer or meningeal syndrome may help doctors identify biomarkers related to cancer.~PURPOSE: This clinical trial is studying cerebrospinal fluid samples in diagnosing carcinomatous meningitis in patients with cancer or meningeal syndrome.", - "NCTID": "NCT00938756" - }, - { - "brief_title": "Ondansetron for Pediatric Mild Traumatic Brain Injury", - "phase": "Phase 1", - "drugs": "['Ondansetron', 'PLacebo']", - "drugs_list": [ - "Ondansetron", - "PLacebo" - ], - "diseases": "['Traumatic Brain Injury', 'Brain Concussion']", - "diseases_list": [ - "Traumatic Brain Injury", - "Brain Concussion" - ], - "enrollment": "16.0", - "inclusion_criteria": "inclusion criteria: \n\n Children aged between 8 and 17 years old. This will be limited to this small spectrum of age to insure better homogeneity in the evaluation of the participants and streamlining of outcome measures. Also, this is the age group for which our measurement tool has been validated. \n\n Occurrence of a mTBI as defined by the presence of a head trauma, a Glasgow coma scale of 13 to 15 and at least one of the three following criteria4 : \n\n Any period of loss of consciousness. \n\n Any loss of memory for events immediately before or after the accident. \n\n Any alteration in mental state at the time of the accident (eg, feeling dazed, disoriented). \n\n And the absence of the following criteria: \n\n Post-traumatic amnesia greater than 24 hours. \n\n Glasgow Coma Scale < 13, 30 minutes post accident. \n\n The trauma occurred in the preceding 24 hours. \n\n ", - "exclusion_criteria": ": \n\n 1. Inability to obtain a proper written informed consent (language barrier, absence of a parental authority, developmental delay, intoxication, patient too confuse to consent according to the treating physician). \n\n 2. Known allergic reaction or intolerance to ondansetron. 3. Known rhythm or cardiac problem, or history of sudden death in the proximal family 4. Patients who are taking a medication which could increase the QT interval. 5. Patients who received ondansetron in the previous 24 hours 6. Any abnormality on radiological studies, including any bleeding in the brain or skull fracture. \n\n 7. Multi-system injuries with treatment requiring admission to hospital or procedural sedation in the ED.", - "brief_summary": "Background: Most patients suffering from mild Traumatic Brain Injury (mTBI) present persistent symptoms at one week post injury. A systematic review showed a paucity of studies for short term outcomes following mTBI. Among potential treatments for mTBI, ondansetron has shown promising results based on clinical experience and a single retrospective study. Objectives: The primary objective of this pilot study is to determine the feasibility of a randomized controlled trial evaluating the effect of ondansetron to decrease post concussion symptoms at one week following mTBI in children. More specifically, this pilot study will evaluate the proportion of participants who complete assessment at one week following intervention. Method: This will be a randomized, double blinded, controlled trial performed among children aged between 8 and 17 years old who sustained a mTBI in the previous 24 hours. Participants visiting the emergency department will be randomized to receive one dose of either ondansetron or placebo. The primary outcome of interest is defined as an increase from pre-concussion baseline of at least 3 symptoms from the Post Concussion Symptom Inventory (PCSI) one week following trauma. Secondary outcomes will include time to full recovery, mean PCSI score, and outcomes at one month following head trauma. The primary analysis will compare the proportion of participants with persistence of symptoms at one week in both groups. The full study sample size was calculated to have 90% power to detect a decrease in the proportion of persistence of symptoms from 50% to 30% with an alpha value of 0.05. Approximately 126 patients will therefore be recruited in each arm. The investigators plan to recruit 30 participants (10% of the final population) for the pilot study. Expected results: This pilot study should confirm the feasibility of the randomized controlled trial by showing that 90% of the recruited participants provide data on the primary outcome at one week following intervention. On the long term, the investigator expect that ondansetron will decrease the proportion of patients sustaining persistent symptoms of concussion from 50% to lower than 30%.", - "NCTID": "NCT01815125" - }, - { - "brief_title": "Cardiac Arrest Recovery EEG Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cardiac Arrest', 'Arrhythmia']", - "diseases_list": [ - "Cardiac Arrest", - "Arrhythmia" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Cardiac Arrest: \n\n Patients 18 years and older: \n\n with cardiac arrest in the hospital and successfully resuscitated, or \n\n with cardiac arrest out of the hospital and successfully resuscitated \n\n ICD patients: \n\n Patients 18 years and older: \n\n Who are undergoing elective procedure in the electrophysiology laboratory for placement of a cardiac defibrillator and who will most likely undergo induction of ventricular arrhythmia as part of the procedure \n\n ", - "exclusion_criteria": ": \n\n Cardiac Arrest: \n\n Cardiac arrest and a known pre-existing cerebral pathology such as brain tumor, cerebral hemorrhage, encephalitis or immediately post-op neurosurgery. \n\n CNS infection \n\n Skull defects and scalp diseases that are not amenable to standard EEG testing \n\n ICD patients: \n\n Known pre-existing cerebral pathology such as brain tumor, cerebral hemorrhage, encephalitis or immediately post-op neurosurgery. \n\n CNS infection \n\n Skull defects and scalp diseases that are not amenable to standard EEG testing", - "brief_summary": "The purpose of the study is to collect EEG's as close to the cardiac arrest as possible using a standard hospital EEG machine and an investigational EEG device to help determine the neurological status of the cardiac arrest patient and to help decide on possible treatment and chance of recovery. The investigational EEG machine will be simple to operate as well as easy to interpret for the clinician and the nurses. It is not to replace the electrophysiologist interpretation but to determine ealy on if further evaluation and treatment can help the patient.", - "NCTID": "NCT00483873" - }, - { - "brief_title": "Treatment of West Nile Virus With MGAWN1", - "phase": "Phase 2", - "drugs": "['MGAWN1', 'Placebo - normal saline']", - "drugs_list": [ - "MGAWN1", - "Placebo - normal saline" - ], - "diseases": "['West Nile Neuroinvasive Disease', 'West Nile Virus Infection', 'Encephalitis', 'Meningitis', 'Acute Flaccid Paralysis', 'West Nile Fever']", - "diseases_list": [ - "West Nile Neuroinvasive Disease", - "West Nile Virus Infection", - "Encephalitis", - "Meningitis", - "Acute Flaccid Paralysis", - "West Nile Fever" - ], - "enrollment": "13.0", - "inclusion_criteria": "inclusion criteria: \n\n Provide written informed consent \n\n Be >=18 years of age at the time of enrollment \n\n Have West Nile Fever defined as: \n\n temperature >38\u00b0C, headache, AND \n\n positive diagnostic test for WNV Ribonucleic acid or Immunoglobulin M with serum or cerebrospinal fluid (CSF) \n\n OR have West Nile Neuroinvasive Disease (includes neurological signs and/or symptoms of West Nile meningitis, encephalitis, and/or acute flaccid paralysis), defined as: \n\n \u2022 West Nile encephalitis (must meet criteria a and b below) \n\n Encephalopathy (depressed or altered level of consciousness, lethargy, or personality change lasting 24 hours) \n\n CSF pleocytosis >=5 cells/mm^3 \n\n AND/OR \n\n \u2022 West Nile meningitis (must meet criteria c and d) \n\n Clinical signs of meningeal inflammation, including nuchal rigidity, Kernig or Brudzinski sign, photophobia, or phonophobia \n\n CSF pleocytosis >=5 cells/mm^3 \n\n AND/OR \n\n \u2022 Acute flaccid paralysis (must meet criteria e and f) \n\n Acute onset of limb weakness with marked progression over 48 hours \n\n Two or more of the following conditions: \n\n asymmetry to weakness \n\n areflexia or hyporeflexia of affected limb(s) \n\n absence of pain, paresthesia, or numbness in affected limb(s) \n\n CSF pleocytosis >=5 cells/mm^3 \n\n CSF elevated protein levels (4.5 g/L) \n\n electrodiagnostic studies consistent with an anterior horn cell process \n\n or abnormal increased signal in the anterior gray matter as documented by spinal cord magnetic resonance imaging \n\n Have epidemiological factors consistent with West Nile Virus infection (must meet criterion a or b below): \n\n Appropriate time of year for West Nile Virus transmission in region \n\n Travel history to a region where West Nile Virus is active \n\n Develop signs and/or symptoms within 14 days before study enrollment. \n\n If female of childbearing potential or male and in a sexual relationship with a female of childbearing potential, agree (or have partner agree) to practice abstinence or use 2 of the following methods of contraception for 120 days (approximately 4 months) after study drug administration: \n\n Oral contraceptives, or other form of hormonal birth control including hormonal vaginal rings or transdermal patches \n\n An intrauterine device \n\n Barrier contraception (condom) with a spermicide (i.e., female subject ensures use by male partner[s]) \n\n Any other equivalent method of contraception (as judged by the investigator)", - "exclusion_criteria": "", - "brief_summary": "This study will test a drug called MGAWN1 for the treatment of West Nile infections.", - "NCTID": "NCT00927953" - }, - { - "brief_title": "Correlation Between Headaches and Septum and Nasal Mucosa Contact", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Nasal Septum Deviation', 'Headache']", - "diseases_list": [ - "Nasal Septum Deviation", - "Headache" - ], - "enrollment": "2000.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients older than 18 years whom underwent sinuses or facial tomography. \n\n ", - "exclusion_criteria": ": \n\n Patients with clinical history of trauma", - "brief_summary": "Headache is the most common complaint to neurologists. In the 80\u00b4s and 90's few papers, with limited number of patients, have proposed the association between nasal septum contact and headache. The International Classification of Headaches Disorders proposed specific diagnostic criteria for this entity.~With the major use of CT scans, the contact between nasal mucosa and septum is daily observed in many patients without complaint of headache.~The purpose of this study is to determine if there is any correlation between nasal and septum mucosa contact and the prevalence of headache. The investigators hypothesized that no correlation will be found using CT scans in a large series of patients.", - "NCTID": "NCT01943929" - }, - { - "brief_title": "PBASE-system Acute Migraine Clinical Investigation", - "phase": "", - "drugs": "['PBASE-system 2.0']", - "drugs_list": [ - "PBASE-system 2.0" - ], - "diseases": "['Acute Migraine']", - "diseases_list": [ - "Acute Migraine" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Willing and able to provide written informed consent prior to participation in the clinical investigation \n\n Male or female aged between 18 and 65 years \n\n Diagnosed as suffering from migraine with or without aura according to IHS classification (ICHD-II) \n\n Reported history of 2 to 6 migraine episodes per month during previous 3 months, confirmed during a prospective baseline period of one month \n\n Reported history of no less than 50% of migraine episodes involving moderate or severe pain intensity, confirmed during a prospective baseline period of one month \n\n Reported history of at least 48 hours of freedom from headache between migraine attacks, confirmed during a prospective baseline period of one month \n\n Reported history of the majority of untreated migraine attack durations lasting 8 hours or more \n\n Onset of migraine headache occured before age 50 \n\n Reported history of migraine for more than one year \n\n Able and willing to maintain current preventive headache medication regimen(s) (no change in type, frequency or dose) from baseline screening visit to 2 weeks post-treatment \n\n Able to understand and complete the electronic diary \n\n Experiencing an acute migraine attack of moderate to severe pain intensity at the time of treatment \n\n Treatment is possible within 5 hours of migraine onset \n\n ", - "exclusion_criteria": ": \n\n Reported history of 15 or more headache days per month (i.e. headaches of any kind), confirmed during a prospective baseline period of one month \n\n Reported frequency of non-migraine headaches exceeding 6 days per month, confirmed during a prospective baseline period of one month \n\n Unable to distinguish between migraine headaches and other headache types at the onset of a migraine attack \n\n Treatment with Botox received within 6 months of the screening visit, or between the screening and treatment visit \n\n Previously treated with an implantable stimulator or any implantable devices in the head and/or neck \n\n Diagnosed as having a pronounced anterior septal deviation \n\n History of sinus surgery, transphenoidal surgery for pituitary or other lesions or CSF rhinorrhea \n\n Fitted with a pacemaker /defibrillator \n\n Previously treated with radiation to the face \n\n Ongoing bacterial infection in the nasal cavity \n\n History of nose bleeds (epistaxis) \n\n Ongoing malignancy in the nasal cavity \n\n Concomitant condition that could cause excessive bleeding \n\n Known allergy to polyvinylchloride,the material used for fabrication of the balloon part of Catheter A100, or medicinal liquid paraffin \n\n Concurrent condition or risk of non-compliance that, in the investigator's opinion, may affect the interpretation of performance or safety data or which otherwise contraindicates participation in a clinical investigation \n\n Any change in migraine prophylaxis between the screening and treatment visit \n\n Women of childbearing potential who is pregnant or at risk of becoming pregnant prior to or during the treatment phase \n\n Participation in a clinical research study within 3 months of enrolment or planned participation at any time during this clinical investigation \n\n Considered to meet the definition of vulnerable in the Investigator's opinion \n\n Headache or migraine episode within the 48 hours prior to treatment \n\n PRN (as required) or acute migraine medication(s) taken within the 48 hours prior to treatment", - "brief_summary": "To evaluate the performance and safety of the PBASE-system when used in the treatment of acute migraine episodes of moderate to severe intensity. The study will evaluate the effect of treatment on migraine pain and symptoms during an acute attack and also any long-term effect.", - "NCTID": "NCT01680029" - }, - { - "brief_title": "Oral Glycerol and High-Dose Rectal Paracetamol to Improve the Prognosis of Childhood Bacterial Meningitis", - "phase": "Phase 3", - "drugs": "['Glycerol and paracetamol', 'Paracetamol', 'Paracetamol', 'Paracetamol', 'Placebo', 'Paracetamol and glycerol', 'Glycerol']", - "drugs_list": [ - "Glycerol and paracetamol", - "Paracetamol", - "Paracetamol", - "Paracetamol", - "Placebo", - "Paracetamol and glycerol", - "Glycerol" - ], - "diseases": "['Bacterial Meningitis']", - "diseases_list": [ - "Bacterial Meningitis" - ], - "enrollment": "466.0", - "inclusion_criteria": "inclusion criteria: \n\n All children aged \u2265 2 months, admitted to Queen Elizabeth Hospital, Blantyre, Malawi, with possible or confirmed acute bacterial meningitis \n\n ", - "exclusion_criteria": ": \n\n Age less than two months \n\n Trauma \n\n Relevant underlying illness such as intracranial shunt, previous neurological disease (cerebral palsy, Down's syndrome) \n\n Previous permanent hearing loss (not conductive hearing loss) if known \n\n Immunosuppression except HIV infection.", - "brief_summary": "Bacterial meningitis remains a significant cause of morbidity and mortality in children, especially in countries with limited resources. Efforts to improve the grim outcome have included altering the first line antibiotic therapy, controlling seizures and managing fluids more carefully. Adjuvant therapy of steroids has been used with limited success in children in the West and with no proven value in Malawi and other resource constrained settings. Glycerol has been used to reduce brain oedema in neurosurgery and it has recently been shown to reduce morbidity in childhood meningitis in South America. Paracetamol in a high dosage has been shown to reduce inflammation and cytokine levels in septicaemia with improved outcomes in adults.~In Malawi the investigators have tried adjuvant steroids with no improvement in outcome of childhood meningitis. They have recently concluded a study of ceftriaxone which has shown no improvement in mortality though there is less hearing loss than with chloramphenicol and benzyl penicillin.~Following the encouraging results of the Childhood South American Study it is important to assess the use of adjuvant glycerol in children in the investigators' setting. Paracetamol is routinely used in meningitis because of the accompanying fever and headache. This is an opportunity to study its place as adjuvant therapy more carefully than has previously been done.~The investigators propose a prospective, randomized, double blind 2 by 2 factorial designed study to assess the advantage of ceftriaxone (antibiotic) given with paracetamol and glycerol in combination, singly or with neither adjuvant therapy in childhood bacterial meningitis.", - "NCTID": "NCT00619203" - }, - { - "brief_title": "Daptomycin in Pediatric Patients With Bacterial Meningitis", - "phase": "Phase 1", - "drugs": "['Daptomycin']", - "drugs_list": [ - "Daptomycin" - ], - "diseases": "['Meningitis']", - "diseases_list": [ - "Meningitis" - ], - "enrollment": "1.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 3 months and < 16 years \n\n Bacterial meningitis \n\n Written parental (or appropriate legal representative) informed consent prior to study inclusion \n\n ", - "exclusion_criteria": " \n\n Gram-negative bacteria in the CSF \n\n Creatinine clearance < 80ml/min/1.73m2 \n\n Creatinine phosphokinase level > 2x upper age related norm \n\n Known allergy or hypersensitivity to daptomycin \n\n Known clinical significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, endocrine, hematologic, autoimmune disease, or primary immunodeficiency \n\n Height and weight below 3rd or above 95th percentile \n\n History of, or current muscular disease \n\n Underlying neurological disease with disruption of blood brain barrier \n\n Epilepsy \n\n Muscular weakness, history of peripheral neuropathy, or Guillain-Barr\u00e9 syndrome", - "brief_summary": "5 Children > 3months and < 16 years with Gram-positive meningitis will receive a single dose of daptomycin 24 hours after the first dose of ceftriaxone. 4-8 hours after daptomycin administration a second lumbar puncture is performed to determine the peak concentration of daptomycin in the cerebrospinal fluid. In parallel peak and trough level of daptomycin will be measured in the plasma. The investigators anticipate that daptomycin penetrates into the cerebrospinal fluid in bactericidal concentrations", - "NCTID": "NCT01522105" - }, - { - "brief_title": "Evaluation of Brain Lesions in HIV-infected Patients for Diagnosis of Primary Central Nervous System Lymphoma", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['HIV Infections', 'Lymphoma, AIDS-Related']", - "diseases_list": [ - "HIV Infections", - "Lymphoma", - "AIDS-Related" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult (18 years old or older) HIV-infected patient \n\n HIV infected by OraQuick rapid test using saliva, venipuncture whole blood, or fingerstick whole blood; or by reactive ELISA and Western Blot as determined by an outside CLIA-approved laboratory facility or by NIH Clinical Pathology Laboratory or SAIC-Frederick Inc Monitoring Laboratory. HIV infection as determined by an outside CLIA-approved laboratory facility will be verified by a standard HIV-1 ELISA with Western Blot confirmation prior to brain biopsy. \n\n Evidence of contrast-enhancing focal brain lesion(s) as seen on MRI or CT \n\n Willingness to give informed consent and provided by Durable Power of Attorney. In the event that no Durable Power of Attorney has been designated and the patient is unable to do so, the NIH Ethics Committee will be consulted. All patients must designate a Durable Power of Attorney in order to participate in the study. \n\n Willingness to undergo the procedures involved in the diagnostic evaluation: lumbar puncture, FDG-PET scan, 201Tl-SPECT scan, and brain biopsy. \n\n Permit the storage of blood, CSF, and tissue samples for future research use \n\n Willingness to undergo HLA testing \n\n ", - "exclusion_criteria": ": \n\n Previous PCNSL \n\n History of prior malignancy other than PCNSL unless in remission for 1 year or longer; non-melanoma skin cancer and Kaposi's sarcoma excepted \n\n History of previous diagnosis of toxoplasmic encephalitis or other CNS infection causing focal contrast-enhancing brain lesions \n\n Pregnancy or currently breast feeding \n\n Have any other condition that the research team considers a contraindication to participating in the study, e.g. severe cardiac, renal, or pulmonary dysfunction. \n\n Weight greater than 400 lb for PET and 500 lb for SPECT (limit of the gantry).", - "brief_summary": "This study will evaluate the usefulness of two tests in quickly distinguishing whether a patient with HIV infection and focal brain lesions (an injury in a specific area of the brain) has a rare type of cancer called primary central nervous system lymphoma (PCNSL), or a parasitic infection called toxoplasmic encephalitis.~Toxoplasmic encephalitis is caused by a parasite and can be treated with antibiotics. PCNSL (lymphoma of the brain or spinal cord) must be definitively diagnosed with a brain biopsy (removal of a small piece of brain tissue), and the treatment is radiation therapy and chemotherapy.~The tests under study for diagnosing PCNSL or toxoplasmic encephalitis are measurement of Epstein Barr virus (EBV) DNA in cerebrospinal fluid (CSF) and FDG-PET scan of the brain. EBV is often found in the CSF of people with PCNSL. The study also will compare the accuracy of two imaging techniques-TI-SPECT and FDG-PET-in distinguishing between toxoplasmosis and PCNSL.~Patients 18 years of age and older who have HIV infection and at least one focal brain lesion without a prior history of PCNSL or toxoplasmic encephalitis may be eligible for this study. Each candidate is screened with a medical history, physical examination, blood and urine tests and MRI scans of the brain.~Upon entering the study, all participants take medication to treat toxoplasmic encephalitis. They undergo lumbar puncture (spinal tap) to obtain CSF for analysis, an FDG-PET scan, and a 201TI-SPECT scan. For the PET scan, a radioactive substance is injected into an arm, followed by scanning in a doughnut-shaped machine similar to a CT scanner. SPECT is similar to PET but uses a different radioactive tracer, and the patient lies on a table while the SPECT camera rotates around the patient's head. Patients whose test results indicate a low risk for lymphoma continue antibiotic therapy for toxoplasmosis. They have repeat MRI scans around 4, 7, and 14 days after starting the drug to monitor the response to therapy. Antiretroviral therapy is initiated in patients who are not already on such a regimen.~Patients whose test results indicate a high risk for PCNSL have a CT scan to look for evidence of lymphoma elsewhere in the body and are referred for consultation with a neurosurgeon to discuss undergoing a brain biopsy. The brain biopsy is done in the operating room under general anesthesia. A small cut is made in the scalp and a small opening is made in the skull over the area of the brain to be biopsied. A needle is placed in the opening in the skull and, guided by CT or MRI, moved to the abnormal area of the brain, where a small piece of tissue is removed for study under a microscope.~Patients found to have toxoplasmosis are discharged from the hospital to the care of their primary care physician after they are getting better and are tolerating all their medications. They return to NIH for follow-up visits about 4 weeks, and 6 months after discharge.~Patients found to have lymphoma are referred to the National Cancer Institute for screening for enrollment in a treatment protocol. Patients who are not eligible for a treatment protocol are referred back to their primary care physician or for another NIH treatment protocol, if one is available. Patients with lymphoma are seen at the NIAID outpatient clinic for follow-up visits and laboratory examinations every 3 months for 2 years.", - "NCTID": "NCT00226304" - }, - { - "brief_title": "Treatment of Acute Migraine Headache in Children", - "phase": "Phase 2", - "drugs": "['Metoclopramide', 'Placebo']", - "drugs_list": [ - "Metoclopramide", - "Placebo" - ], - "diseases": "['Migrainous Headache']", - "diseases_list": [ - "Migrainous Headache" - ], - "enrollment": "31.0", - "inclusion_criteria": "inclusion criteria: \n\n Males or Females age 8-18 years \n\n Girls 11 years or older must have a negative urine/serum pregnancy test. \n\n Diagnosis of pediatric migrainous headache. The criteria for pediatric migraine headache based on the most recent ICHD criteria are listed below. The requirement of 5 attacks (A) will not be required for this study, this making the diagnosis migrainous headache. As described elsewhere in the protocol, this change is required to make the study applicable to ED patients who require treatment before five attacks have occurred. \n\n ", - "exclusion_criteria": ": \n\n Evidence that headache is due to a secondary underlying disorder based on history or physical examination. \n\n Pregnant or lactating females. \n\n Any investigational drug use within 30 days. \n\n Known to have a contraindication to metoclopramide or valproic acid such as pregnancy, liver disease, hematologic disease, or metabolic disease. \n\n Have used metoclopramide (or other antidopaminergic medications) or valproic acid within two days of presentation. \n\n Severe developmental disorders or mental retardation if insufficient information can be obtained to make a clear diagnosis of migraine or judge headache severity. \n\n If patients re-present to the ED, they can not be re-enrolled.", - "brief_summary": "Migraine is common in children and is one of the most common etiologies of headache leading to emergency room presentation in children. Despite this, few studies have investigated the treatment of acute migraine headache in the emergency room. We will perform a prospective, double-blind, placebo-controlled study of metoclopramide versus placebo in the treatment of acute migraine headache. The primary outcome will be the number of subjects headache free at two hours.", - "NCTID": "NCT00355394" - }, - { - "brief_title": "A New Cochlear Implant Electrode For Inner Ear Malformations", - "phase": "", - "drugs": "['Cork Electrode']", - "drugs_list": [ - "Cork Electrode" - ], - "diseases": "['Inner Ear Malformations']", - "diseases_list": [ - "Inner Ear Malformations" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Must have an inner ear malformation \n\n Must meet the criteria for cochlear implantation \n\n ", - "exclusion_criteria": ": \n\n Prior cochlear implantation surgery", - "brief_summary": "The custom made device was produced by Med-El Company. It has a cork like stopper instead of the usual silicon ring to prevent gusher. There are two types of electrodes consisting of different length. Standard one is 25 mm (contact space 1.7 mm) and the short one is 20 mm (contact space 1.3 mm). It was used in 50 patients with different inner ear malformations. Thirteen patients had gusher, and 11 patients oozing during cochleostomy. One patient with initial prototype of the cork electrode had to be revised because of persistent oozing around the electrode. Another patient had slow extrusion of the electrode most probably due to CSF (cerebrospinal fluid) pulsation and had to be revised. Both patients had no more CSF fistula.~CSF fistula in inner ear malformations is a serious situation which may lead to recurrent meningitis. The new cochlear implant electrode with cork stopper looks promising in preventing the postoperative CSF leak around the electrode.", - "NCTID": "NCT02011867" - }, - { - "brief_title": "Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days of Age With Probable and Confirmed Meningitis", - "phase": "Phase 1; Phase 2", - "drugs": "['Meropenem']", - "drugs_list": [ - "Meropenem" - ], - "diseases": "['Meningitis']", - "diseases_list": [ - "Meningitis" - ], - "enrollment": "51.0", - "inclusion_criteria": "inclusion criteria: \n\n Informed consent form signed by the parents/carers \n\n Chronological age below 90 days inclusive \n\n The presence of: \n\n clinical signs consistent with BM (hyperthermia or hypothermia or temperature instability PLUS 1 or more neurological findings among coma, seizures, neck stiffness, apnoea, bulging fontanelle), \n\n OR CSF pleocytosis (\u2265 20 cells/mm3) \n\n OR a positive Gram stain of CSF. \n\n ", - "exclusion_criteria": ": \n\n Presence of a CSF device \n\n Proven viral or fungal meningitis \n\n Severe congenital malformations if the infant is not to expect to survive for more than 3 months \n\n Other situations where the treating physician considers a different empiric antibiotic regimen necessary \n\n Known intolerance or contraindication to the study medication \n\n Participation in any other clinical study of an investigational medicinal product \n\n Renal failure and requirement of haemofiltration or peritoneal dialysis \n\n Meningitis with an organism known to be resistant to meropenem", - "brief_summary": "This phase I-II multicenter international trial is designed to study the pharmacokinetics of meropenem and to characterize the safety profile of meropenem in the treatment of infants \u2264 90 days of postnatal age with probable or confirmed bacterial meningitis.", - "NCTID": "NCT01554124" - }, - { - "brief_title": "Fibrin Sealant for the Sealing of Dura Sutures", - "phase": "Phase 2", - "drugs": "['Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)', 'Standard of care']", - "drugs_list": [ - "Fibrin Sealant", - "Vapor Heated", - "Solvent/Detergent-treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)", - "Standard of care" - ], - "diseases": "['Pathological Processes in the Posterior Fossa', 'Dura Defects']", - "diseases_list": [ - "Pathological Processes in the Posterior Fossa", - "Dura Defects" - ], - "enrollment": "95.0", - "inclusion_criteria": "inclusion criteria: \n\n Preoperative inclusion criteria: \n\n Subjects undergoing elective craniotomy / craniectomy for pathological processes in the posterior fossa (such as benign and malignant tumors, vascular malformations, and Chiari 1 malformations) that result in dura defects requiring dura substitution for closure and who are able and willing to comply with the procedures required by the protocol \n\n Signed and dated written informed consent from the subject or from his/her legal representative prior to any study-related procedures \n\n Age >= 3 years, either gender \n\n Intraoperative inclusion criteria: \n\n Surgical Wound Classification Class I and Risk Index Category (RIC) <= 2. Penetration of mastoid air cells during partial mastoidectomy is permitted and will be recorded. \n\n A patch of autologous fascia or pericranium or suturable collagen-based dura substitute was cut to size and then sutured into the dura defect. \n\n The hem of native dura exposed along and under the craniotomy edge is wide enough to facilitate suturing and to allow for sufficient surface area for adherence of the investigational product. \n\n ", - "exclusion_criteria": ": \n\n Preoperative ", - "brief_summary": "The purpose of this study is to investigate the efficacy and safety of FS VH S/D 500 s-apr, a double virus-inactivated biological two-component fibrin sealant, for use in posterior fossa surgery as an adjunct to dura and dura substitute sutures in preventing postoperative cerebrospinal fluid (CSF) leakage.", - "NCTID": "NCT00681824" - }, - { - "brief_title": "Omr-IgG-am(Trademark) for Treating Patients With or at High Risk for West Nile Virus Disease", - "phase": "Phase 2", - "drugs": "['Omr-IgG-am']", - "drugs_list": [ - "Omr-IgG-am" - ], - "diseases": "['West Nile Virus']", - "diseases_list": [ - "West Nile Virus" - ], - "enrollment": "2.0", - "inclusion_criteria": "inclusion criteria: \n\n In order to participate in this clinical trial, all subjects (or legal representative) must provide written informed consent. Only patients meeting entry criteria will be enrolled. Eligible subjects must fall into one of two categories: \n\n A. Hospitalized patients greater than or equal to 18 years of age with encephalitis and/or myelitis as defined below: \n\n New neurologic abnormality: \n\n Asymmetric extremity weakness without sensory abnormality; or \n\n Other neurologic abnormality (including altered level of consciousness, dysarthria and dysphagia) plus fever (subjective or objective) within the previous 4 days \n\n AND \n\n CSF examination within the previous 96 hours showing: \n\n Absence of organism on gram or fungal stain \n\n White blood cell count greater than or equal to 4 per mm(3) corrected for significant red blood cell contamination. \n\n Ratio of CSF: plasma glucose of greater than or equal to 40% (CSF glucose/plasma glucose greater than or equal to 0.4) \n\n OR \n\n B. Hospitalized patients without encephalitis and/or myelitis as defined below who meet the following criteria: \n\n A positive IgM serology or PCR test for WNV in blood or cerebrospinal fluid, \n\n AND \n\n Clinical illness compatible with WNV infection as described by occurrence of greater than or equal to 3 of the following findings during the preceding less than or equal to 10 days: \n\n Diarrhea, headache, fever greater than 38 degrees Celsius, nausea and/or vomiting, myalgias and/or arthralgias, nuchal rigidity, macular or papular rash, new neurological abnormality \n\n AND \n\n A risk factor for the development of WNV neurologic disease as defined by: \n\n Age greater than or equal to 40 years, or \n\n Age greater than or equal to 18 years, plus immunosuppression, as defined by any of the following: \n\n Hematologic malignancy, previous diagnosis of diabetes mellitus, chemotherapy within previous 4 weeks, stem cell transplant recipient or solid organ transplant recipient, taking immunosuppressive medications, including prednisone greater than or equal to 7.5 mg/day within the previous 4 weeks, history of human immunodeficiency virus (HIV) infection, congenital immunodeficiency syndrome (including common variable immunodeficiency) \n\n ", - "exclusion_criteria": ": \n\n Unable to obtain valid informed consent \n\n History of intolerance (including anaphylaxis) to IVIg or related compounds \n\n Known history of IgA deficiency \n\n Known history of hypersensitivity to maltose. \n\n History of (or at time of study entry) hyperviscosity syndrome including but not limited to: \n\n Waldenstrom's macroglobulinemia \n\n Multiple myeloma \n\n Total white blood cell count greater than 80,000/mm(3) \n\n Hematocrit greater than 55% \n\n Platelet count greater than 700,000/mm(3) \n\n Meets criteria of Class III or IV of the New York Heart Association Classification for congestive heart failure patients \n\n Serum creatinine greater than 2.5 mg/dL or requires dialysis \n\n Alternate explanation (as determined by the investigator) for clinical findings (such as structural brain lesion, cerebrovascular accident, or other infectious disease, including confirmed infections with other flaviviruses) \n\n Pregnant or breastfeeding (negative serum or urine pregnancy test within previous 72 hours if woman is not postmenopausal or has not been surgically sterilized) \n\n Investigator's opinion that patient would be unable to adhere to protocol requirements \n\n Receipt of ribavirin, interferon alpha, intravenous immunoglobulin or any investigational drug for treatment of WNV or hepatitis within 15 days prior to study entry.", - "brief_summary": "Investigators will assess whether Omr-IgG-am(Trademark), an intravenous immunoglobulin (IVIg) containing antibodies specific for West Nile virus (WNV), is safe and well-tolerated in patients with suspected or laboratory diagnosed WNV disease. An initial estimation of efficacy will also be made.~This Phase I/II study will enroll hospitalized adults with a presumptive diagnosis of West Nile encephalitis and/or myelitis or those with a positive laboratory test for diagnosis of WNV infection who are at high risk for progressing to severe neurologic disease based on age or immunosuppression. Patients will be randomized in blocks of five to receive either Omr-IgG-am(Trademark), Polygam(Registered Trademark) S/D (IVIG containing minimal anti-WNV antibodies) or normal saline in a ratio of 3:1:1. Patients and investigators will be blinded to treatment assignments.~Patients will receive a single intravenous dose of study medication or one of two placebos. The study participants will receive 0.5 grams/kg of Omr-IgG-am(Trademark) or Polygam(Registered Trademark) S/D or a comparable volume of normal saline. All patients will be followed for safety, natural history endpoints, and efficacy. A subset of patients will have pharmacokinetic measurements of specific anti- WNV antibodies assessed following treatment.~The primary endpoints are safety and tolerability following Omr-IgG-am(Trademark) administration.~Secondary endpoints include pharmacokinetics of specific anti-WNV antibodies, mortality in confirmed WNV positive patients, and the combination of mortality and functional status at three months in both confirmed WNV-infected patients and all patients by intention to treat. This combined endpoint will be measured using four standardized measures of cognitive and functional status: the Barthel Index; the Modified Rankin Scale; the Glasgow Outcome Score; and the Modified Mini-Mental Status Examination. A comparison of outcomes will be made for the group receiving Omr-IgG-am(Trademark) versus those receiving either placebo, and between the two placebo groups. Other secondary endpoints include the proportion of patients in each group returning to pre-morbid baseline and each subject's improvement at 3 months as compared to that subject's worst (of any previous) evaluation.~Natural history endpoints will also be assessed. They will include the duration of intensive care unit (ICU) and hospital stay, development and persistence of WNV-specific IgG and IgM antibodies, combined functional score and mortality at 3 months between the group with encephalitis and/or myelitis at baseline versus the group with a positive WNV test only, outcomes in patients treated late in coma and correlation of outcome with time-to-treatment following symptom onset.", - "NCTID": "NCT00069316" - }, - { - "brief_title": "Surveillance of Hospitalised Pneumonia and Bacterial Meningitis in T\u00f4ne District, Togo, 2010-2013", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pneumonia, Bacterial', 'Pneumonia, Viral', 'Meningitis, Bacterial']", - "diseases_list": [ - "Pneumonia", - "Bacterial", - "Pneumonia", - "Viral", - "Meningitis", - "Bacterial" - ], - "enrollment": "2000.0", - "inclusion_criteria": "Pneumonia surveillance: \n\n inclusion criteria: \n\n resident of T\u00f4ne sanitary district - requiring hospitalisation for at least one night for clinical pneumonia syndrome \n\n hospitalised in a study site during the study period \n\n ", - "exclusion_criteria": ": \n\n absence of informed consent by patient or legal tutor \n\n Meningitis surveillance: \n\n inclusion criteria: \n\n resident of T\u00f4ne sanitary district \n\n presenting clinical signs of acute bacterial meningitis \n\n hospitalised in a study site during the study period \n\n ", - "brief_summary": "The aim of this study is to estimate the burden of disease due to pneumococci, other bacteria and viruses in the African meningitis belt prior to pneumococcal conjugate vaccine introduction and to estimate the population impact of the vaccine after its implementation in 2014. In a defined population of a sanitary district in northern Togo, during the period 2010 to 2017, investigators enroll patients of all ages with suspected pneumonia requiring hospitalization or suspected bacterial meningitis. Patients are evaluated by bacteriology and molecular biology techniques on blood, cerebro-spinal fluid, nasal aspirates and by chest X-ray.", - "NCTID": "NCT01747369" - }, - { - "brief_title": "Slow Initial \u03b2-lactam Infusion With High-dose Paracetamol to Improve the Outcomes of Childhood Bacterial Meningitis", - "phase": "Phase 4", - "drugs": "['Infusion with paracetamol', 'Bolus without paracetamol']", - "drugs_list": [ - "Infusion with paracetamol", - "Bolus without paracetamol" - ], - "diseases": "['Bacterial Meningitis']", - "diseases_list": [ - "Bacterial Meningitis" - ], - "enrollment": "375.0", - "inclusion_criteria": "Eligibility criteria: \n\n The study entry is assessed for all children at age 2 months - 15 years who present at these centers with the symptoms and signs suggestive of bacterial meningitis (BM), and to whom lumbar puncture is performed. \n\n inclusion criteria: \n\n All patients whose cerebrospinal fluid (CSF) turns out to be cloudy, positive by Gram staining or latex agglutination, or shows at least 50 leukocytes per mm3, will be enrolled in the study. \n\n Participants: ", - "exclusion_criteria": " \n\n ", - "brief_summary": "The main purpose of this trial is to test if mortality of childhood bacterial meningitis can be reduced by slow, continuous infusion of cefotaxime initially, instead of the traditional bolus administration four times daily (qid), combined with high-dose paracetamol orally, when both treatments are executed for the first 4 days. The series will be collected at Hospital Pedi\u00e1trico David Bernardino, Luanda, Angola.~The recruitment of patients begins, the conditions permitting, in early 2012. The criteria for patient participation is a child at the age of 2 months to 15 years who presents with the symptoms and signs suggestive of bacterial meningitis, for whom a lumbar puncture is performed, and the cerebrospinal fluid analysis suggests bacterial meningitis.", - "NCTID": "NCT01540838" - }, - { - "brief_title": "Protocol to Ease Acute Cephalalgia in Emergency-department", - "phase": "", - "drugs": "['Recommendation to use global headache treatment protocol']", - "drugs_list": [ - "Recommendation to use global headache treatment protocol" - ], - "diseases": "['Cephalalgia']", - "diseases_list": [ - "Cephalalgia" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Complain about cephalalgia \n\n Age 28 to 55 years. \n\n ", - "exclusion_criteria": ": \n\n Fever > 38,0 \u00b0C \n\n History of breath disease, long term use of oxygen therapy, chronic obstructive pulmonary disease, dyspnea \n\n History of cranial traumatism, heart attack, cerebrovascular accident <3 month \n\n Inability to read or understand french. \n\n Pregnancy", - "brief_summary": "The purpose of this study is to determine if the use of a therapeutic and global protocol to relieve cephalalgia is helpful in the emergency department of Grenoble University Hospital.", - "NCTID": "NCT02236442" - }, - { - "brief_title": "Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion", - "phase": "Phase 3", - "drugs": "['Arterial line', 'Motion']", - "drugs_list": [ - "Arterial line", - "Motion" - ], - "diseases": "['Healthy', 'Hypoxia']", - "diseases_list": [ - "Healthy", - "Hypoxia" - ], - "enrollment": "18.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female of any race \n\n 18-50 years old, inclusive \n\n Females: negative urine pregnancy test on the day of study participation (prior to exposure to hypoxia) \n\n Completed within the last year: physical exam by a licensed physician, physician assistant (PA), or advanced practice nurse; including a 12 lead ECG, a medical history, and blood test (complete blood count and sickle cell trait/disease screening) \n\n Meets specific demographic requirements for the monitoring device under study \n\n Willing and able to provide written informed consent \n\n Able to participate for the duration of the evaluation \n\n ", - "exclusion_criteria": ": \n\n A room-air baseline % modulation < 1.5% on all four fingers on the test hand \n\n Under 18 years or over 50 years of age \n\n Pregnant and/or lactating women \n\n Hypertension: on three consecutive readings, systolic pressure greater than 145 mm Hg or diastolic pressure greater than 90 mm Hg \n\n Ventricular premature complexes (VPC's) that are symptomatic or occur at a rate of more than four per minute \n\n History of seizures (except childhood febrile seizures) or epilepsy \n\n History of unexplained syncope \n\n Daily or more frequent use of anxiolytic drugs (benzodiazepines) for treatment of anxiety disorder \n\n Recent history of frequent migraine headaches: average of two or more per month over the last year \n\n Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.) \n\n History of acute altitude sickness at or below moderate elevation (up to 5,000-10,000 feet) defined as three or more of the following symptoms: moderate to severe headache, general malaise, dizziness/lightheadedness, nausea/vomiting, fatigue/weakness, shortness of breath, nosebleed, persistent rapid pulse, or peripheral edema \n\n History of significant respiratory disease such as severe asthma or emphysema or sleep apnea \n\n Sickle cell disease or trait \n\n Clinically significant abnormal finding on medical history, physical examination, clinical laboratory test or ECG. Clinical significance will be assessed by the principal investigator or study physician as designated. \n\n History of stroke, transient ischemic attack or carotid artery disease \n\n History of myocardial ischemia, angina, myocardial infarction, congestive heart failure or cardiomyopathy \n\n History of chronic renal impairment \n\n Severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors \n\n Unwillingness or inability to remove colored nail polish or artificial nails from test digit(s) \n\n Unwillingness or inability to give informed consent \n\n Prior or known allergies to: lidocaine (or similar pharmacological agents, e.g., Novocain) or heparin \n\n Recent arterial cannulation (i.e., less than 30 days prior to study date) \n\n Six or more arterial cannulations of each (right & left) radial artery \n\n History of clinically significant complications from previous arterial cannulation \n\n Current use of blood thinners: prescription or daily aspirin use \n\n History of bleeding disorders or personal history of prolonged bleeding from injury.", - "brief_summary": "To validate the proposed claims for pulse rate and saturation accuracy in a diverse subject population during motion over a specified saturation range.", - "NCTID": "NCT02247765" - }, - { - "brief_title": "What Needle Diameter Should Physician Use When They Perform Lumbar Puncture ? A Randomized Controlled Trial", - "phase": "Phase 4", - "drugs": "['whitacre 24 gauge', 'whitacre 22 gauge']", - "drugs_list": [ - "whitacre 24 gauge", - "whitacre 22 gauge" - ], - "diseases": "['Post-lumbar Puncture Headache', 'Backache']", - "diseases_list": [ - "Post-lumbar Puncture Headache", - "Backache" - ], - "enrollment": "62.0", - "inclusion_criteria": "inclusion criteria: \n\n All adult patients (>= 18 years old) referred at the Neurological Day Center to get a lumbar puncture \n\n ", - "exclusion_criteria": ": \n\n Contraindication to get a lumbar puncture", - "brief_summary": "This study is intended to help guide the choice of needle diameter when performing a lumbar puncture.~Smaller spinal needles have been shown to decrease rate of adverse events such as post-lumbar puncture headache and hearing loss.~The main drawback to using smaller needles is diminished flow rate; some textbooks recommend using needles no smaller than 22 gauge because of the slow flow rate though others recommend smaller needles, namely 22-24 gauge.~Some authors have described a successful use of spinal needles as small as 25 gauge when performing a lumbar puncture.~The investigators do not believe that the flow-rate difference between 22 and 24 gauge needles is significant enough to justify using the larger needles.~The investigators trial will compare the Whitacre 22 gauge and Whitacre 24 gauge needles for flow rate, and incidence of the known complications of pain during procedure and backache at 8 and 15 days post-procedure.~The investigators will also look at whether smaller needles are associated with less pain during the procedure and less backache the next 2 weeks after the procedure.", - "NCTID": "NCT01481922" - }, - { - "brief_title": "In Vivo Alzheimer Proteomics", - "phase": "", - "drugs": "['administration of stable isotope-labelled leucine-', 'collection of CSF, blood, urine, saliva']", - "drugs_list": [ - "administration of stable isotope-labelled leucine-", - "collection of CSF", - "blood", - "urine", - "saliva" - ], - "diseases": "['Probable Alzheimer Disease', 'Parkinson Disease', 'Neurological Disease Without Cognitive Degradation', 'Brain Trauma', 'Acute Hydrocephaly']", - "diseases_list": [ - "Probable Alzheimer Disease", - "Parkinson Disease", - "Neurological Disease Without Cognitive Degradation", - "Brain Trauma", - "Acute Hydrocephaly" - ], - "enrollment": "89.0", - "inclusion_criteria": "inclusion criteria: \n\n Reports written consent, informed and signed by the patient and a trusted person \n\n Subject member or beneficiary of a social security system \n\n Specific criteria for group 1 and 2B : \n\n Age between 55 and 85 years old for patients \n\n Subject with AD or other neurodegenerative disease (frontotemporal dementia, dementia with Lewy bodies, Parkinson disease) \n\n Subjects with chronic adult hydrocephalus (HCA) requiring depletion lumbar puncture (PL) \n\n Specific criteria for group 2A : \n\n - Adult patient requiring neurosurgery with CSF shunt (subject with brain trauma, acute hydrocephaly) and favorable evolution that allows removal of the shunt \n\n ", - "exclusion_criteria": ": \n\n Patient deprived of liberty by judicial or administrative decision \n\n Major protected by law \n\n Pregnancy, women of childbearing age with risk of pregnancy, or breast-feeding \n\n Presence of a transmissible viral disease (HlV, hepatitis B and C) \n\n Patient included in a clinical trial \n\n lnadequate cardiac, hepatic or severe renal disfunction \n\n Disease amino acid metabolism (Leucinose..) \n\n ", - "brief_summary": "In France, an estimated 860 000 patients are affected by Alzheimer Disease (AD) which represents, as in other developed countries, a major public health issue. In many cases, AD diagnosis is uncertain and its clinical evolution unpredictable. The exactitude of the diagnosis is however particularly important in the perspective of the validation and use of new therapeutic strategies in AD. Detection of cerebrospinal fluid (CSF) diagnosis biomarkers fell short in the detection, of atypical/mixed cases, of some differential diagnosis, and in differentiating rapid or slow clinical evolutions. Hence, CSF analysis gives a unique opportunity to detect and validate biomarkers in many neurological disorders. Nevertheless, in medical practice, CSF biological analysis is currently limited to a small number of analytes.Quantitative and targeted mass spectrometry, especially operated in the Multiple reaction monitoring mode (MRM), represents an alternative to immunodetection and could be used to detect specific biomarkers in complex matrices such as plasma by specifically discriminating the proteotypic peptides corresponding to each proteins. Mass spectrometry has also the ability to distinguish and quantify isotopically labelled and unlabeled selected targets. This ability was used in a publication by the group of R. Bateman (Washington University, St Louis, USA) who could, after administering stable isotope-labelled leucine, evaluate Ab synthesis and clearance in humans. This approach has an enormous potential to study the metabolism of proteins within the human CNS and consequently help in the understanding and diagnosis of neurological disorders.The main objective of this program is set up a targeted quantitative mass spectrometry method for existing and stable isotope-labelled CSF biomarkers in the neurological field; exploit this approach for diagnostic purpurses and to gain knowledge in the pathophysiology of diseases.", - "NCTID": "NCT02263235" - }, - { - "brief_title": "Study on the Efficacy of Phenytoin in the Prophylaxis of Seizures of Patients With Pneumococcal Meningitis at Least 50 Yrs Old.", - "phase": "Phase 4", - "drugs": "['Phenytoin', 'placebo']", - "drugs_list": [ - "Phenytoin", - "placebo" - ], - "diseases": "['Seizures', 'Pneumococcal Meningitis']", - "diseases_list": [ - "Seizures", - "Pneumococcal Meningitis" - ], - "enrollment": "26.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult patients > or = 50 years old. \n\n Diagnosed of pneumococcal meningitis due to clinical characteristics plus a positive CSF Gram stain and/or a detection of pneumococcal antigen or PCR \n\n or \n\n Suspected pneumococcal meningitis since it is an episode related to otitis, pneumonia, sinusitis or pericranial fistula or in patients with known risk factors such as myeloma or splenectomy. \n\n ", - "exclusion_criteria": ": \n\n To have seizures prior to arrive to the hospital or the inclusion in the study. \n\n Pregnancy or breastfeeding. \n\n To have conduction abnormalities in ECG. \n\n History of allergy or intolerance to phenytoin. \n\n Patients with meningitis as a complication of neurosurgical procedures. \n\n Epileptic patients taking usually anticonvulsivants. \n\n Refusal by the patient or family to participate and/or to sign the informed consent.", - "brief_summary": "To evaluate the efficacy of the prophylaxis with phenytoin in the prevention of seizures in patients with pneumococcal meningitis. Hypothesis: Administration of prophylactic phenytoin will reduce the incidence of seizures in patients with pneumococcal meningitis older than 50 yrs.", - "NCTID": "NCT01478035" - }, - { - "brief_title": "Study to Evaluate Safety and Effectiveness of Spinal Sealant", - "phase": "", - "drugs": "['Spinal Sealant System', 'Standard of care']", - "drugs_list": [ - "Spinal Sealant System", - "Standard of care" - ], - "diseases": "['Spinal Procedure Requiring Dura Incision']", - "diseases_list": [ - "Spinal Procedure Requiring Dura Incision" - ], - "enrollment": "158.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who are scheduled for an elective spinal procedure that requires a dural incision will be considered for study participation. \n\n Patient requires a procedure that involving surgical wound classification Class 1/Clean (per CDC criteria) \n\n Presence of a non-watertight dural closure, either spontaneously or upon Valsala maneuver at 20-25 cm H20 for 5-10 seconds. \n\n ", - "exclusion_criteria": ": \n\n Active spinal and/or systemic infection \n\n Patient requires additional spinal surgery within the study time period \n\n Patient has had a previous spinal surgery involving dural exposure and/or entry at the same level(s) as the study procedure \n\n Patient has a pre-existing external lumbar CSF drain or internal CSF shunt \n\n Patient is participating in a clinical trial of another investigational device or drug \n\n Patient with creatinine > 2.0 mg/dL \n\n Patient with total bilirubin > 2.5 mg/dL \n\n Pregnant or breast-feeding females or females who wish to become pregnant during the length of study participation \n\n Patient has been treated with chronic steroid therapy (>4 weeks) unless discontinued more than 6 weeks prior to surgery \n\n Patient has documented history or significant coagulopathy with a PTT >35 sec, PT/INR >1.2, receiving asprin, or NSAIDS at the time of surgery \n\n Patient receiving warfarin or heparin at the time of surgery \n\n Patient has a diagnosed and documented compromised immune system and/or autoimmune disease \n\n Patient has has chemotherapy treatment within 6 months prior to, or planned during the study \n\n Patient has had prior radiation treatment to the surgical site or has planned radiation therapy within 30 days post procedure \n\n Patient has known malignancy or other condition with prognosis shorter than 6 months \n\n Patients with documented history of uncontrolled diabetes \n\n Patient requires use of synthetic or non-autologous duraplasty material \n\n Patient has a gap greater than 2mm remaining after primary dural closure \n\n Patient has undergone laminoplasty decompression \n\n Patient has undergone a syringomyelia procedure where the shunt is not placed in the subarachnoid position \n\n Patient has undergone a Chiari Malformation procedure that does not entail a dural incision at or below the C1 level \n\n The investigator determines that participation in the study may jeopardize the safety or welfare of the patient \n\n The investigator determines that the patient should not be included in the study for reason(s) not already specified", - "brief_summary": "To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain watertight dural closure in patients undergoing spinal surgery.", - "NCTID": "NCT00594035" - }, - { - "brief_title": "The Safety and Effectiveness of Retrovir in HIV-Infected Patients Who Have Problems Related to the Nervous System", - "phase": "", - "drugs": "['Zidovudine']", - "drugs_list": [ - "Zidovudine" - ], - "diseases": "['HIV Infections']", - "diseases_list": [ - "HIV Infections" - ], - "enrollment": "", - "inclusion_criteria": "", - "exclusion_criteria": " \n\n Co-existing Condition: \n\n Patients with the following are excluded: \n\n Neuropsychological (NP) impairments more severe than described in the inclusion criteria. \n\n Evidence of nervous system dysfunction being caused by factors other than HIV infection, including history of head trauma, multiple sclerosis, epilepsy, or presence of concurrent central nervous system (CNS) infections or neoplasms, e.g., toxoplasmosis, primary or metastatic CNS lymphoma, progressive multifocal leukoencephalopathy, cryptococcal or other fungal meningitis, and CNS tuberculous infections. \n\n Lymphoma or other tumor requiring cytotoxic chemotherapy. \n\n Concurrent Medication: \n\n Excluded: \n\n Other antiretroviral agents. \n\n Patients with the following are excluded: \n\n AIDS or advanced ARC. \n\n Neuropsychological (NP) impairments more severe than described above; i.e., defective performance on NP test battery in 3 or more NP areas on the NP screening battery at 2 standard deviations below the mean. \n\n Evidence of nervous system dysfunction being caused by factors other than HIV infection, including history of head trauma, multiple sclerosis, epilepsy, or presence of concurrent central nervous system (CNS) metastatic CNS lymphoma, progressive multifocal leukoencephalopathy, cryptococcal or other fungal meningitis, and CNS tuberculous infections. \n\n Prior Medication: \n\n Excluded: \n\n Antiretroviral agents including zidovudine (AZT). \n\n Prior Treatment: \n\n Excluded within 3 months of study entry: \n\n Blood transfusion. \n\n Impaired performance on a defined neuropsychological test battery. \n\n Asymptomatic HIV infection. \n\n Persistent generalized lymphadenopathy (PGL). \n\n Early AIDS related complex (ARC). \n\n Seropositive for human immunodeficiency virus (HIV) demonstrated by positive ELISA test and confirmed by Western blot with no or minimal symptomatology or HIV infection. \n\n Ability to give informed consent or a person with durable power of attorney who can give informed consent. \n\n Willingness to be followed by the originating medical center for 1 year. \n\n History of drug or alcohol abuse.", - "brief_summary": "To assess the efficacy of Retrovir (AZT) therapy in the treatment of HIV Ab positive persons with impairments in neuropsychological functioning. To assess the safety, virologic, and immunologic effects of AZT therapy in HIV Ab positive persons with neuropsychological impairment but minimal other symptomatology.", - "NCTID": "NCT00002288" - }, - { - "brief_title": "Infection, Sepsis and Meningitis in Surinamese Neonates", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Neonatal Sepsis', 'Neonatal Infection', 'Neonatal Meningitis']", - "diseases_list": [ - "Neonatal Sepsis", - "Neonatal Infection", - "Neonatal Meningitis" - ], - "enrollment": "190.0", - "inclusion_criteria": "inclusion criteria: \n\n This study aims to include all neonates presenting here and at the high and medium care facilities with clinical signs of infection, sepsis or meningitis (age: 0-1 month) that require infection work up (i.e., laboratory testing and culturing): \n\n Baseline controls: uncomplicated jaunice, no other signs of infection \n\n Clinical signs of infection: tachypnea, dyspnea, apnea, grunting, tachycardia, bradycardia, hypotension, poor perfusion, vomitus, abdominal distension, constipation, poor feeding, lethargy, irritability, convulsions, temperature instability, pale, yellow, bleak, petechiae, bruising, bleeding. \n\n ", - "exclusion_criteria": ": \n\n Extreme prematurity: gestational below 32 weeks of gestational age \n\n Extreme dysmaturity: birthweight below 1500 grams \n\n Maternal HIV or malignancy", - "brief_summary": "Suriname is a small developing country in South America with a population of half a million people. Early neonatal death in Suriname is high with 16 per 1000 live births. Unpublished data from the Suriname Perinatal and Infant Mortality Survey estimate contribution of infection to early neonatal mortality at 25% (4 per 1000 live births) of all deaths. In comparison, incidence rates of neonatal sepsis alone are 3.5 per 1000 live births. These numbers indicate an increased burden of neonatal infection in Suriname versus the U.S. In any case about 40 newborns that die each year of infection are a huge loss, also considering the small Surinamese community. Despite this overall idea on the impact of infectious disease in Surinamese neonates exact information regarding incidence, type of infection (e.g., localized, viral, early-onset or late-onset sepsis), risk factors (e.g., insufficient antenatal care, maternal Group B-Streptococcus status), etiology, microbial causes, morbidity, antibiotic treatment (type and duration), and epidemiological determinants (e.g., gestational age, sex, ethnicity) are lacking.~From a clinical perspective, there is still a challenge to identify neonates with infection. Neonates are often admitted with ambivalent clinical symptoms and receive preventive antibiotics that are costly, promote pathogen-resistance, and have negative long-term effects (i.e., on the development of the intestinal bacterial flora). Currently, assessment of blood leukocyte or trombocyte counts and levels of CRP are insufficiently sensitive to be used as biomarkers, while confirmation of actual sepsis or meningitis by positive culture results is relatively rare (0.5-3% in the United States). This complicates decisions on duration of antibiotic treatment and hospitalization significantly, while no other biomarkers exist.~The circulating isoforms of adhesion molecules (cAMs), which mediate interactions of leukocytes with the vascular endothelium, have been proposed as biomarkers for infection and sepsis. During infection they accumulate in the bloodstream as a result of shedding, which represents their removal from cell surfaces of endothelial cells and leukocytes by enzymes called sheddases. Recently, we have reviewed mechanisms behind shedding of cAMs in neonatal, pediatric and adult sepsis. The shedding process reflects a critical and active process in orchestrating interaction between leukocytes and the endothelium for an effective host response, while minimizing collateral tissue damage. As a result, both plasma levels of cAMs and their sheddases are subject to change during infection and sepsis. Additionally, compelling, albeit limited, data suggest changes of levels of cAMs in CSF in adult and pediatric meningitis.~To date, some evidence exists of changes in levels of cAMs during malaria (in children from Malawi) and sepsis, although not sensitive enough to predict outcomes in the clinic. Those levels have never been assessed simultaneously with levels of their sheddases in blood or CSF as a diagnostic tool. We propose that this combined approach may provide more detailed information about the extent of inflammatory activation in neonates.While a balance in levels is maintained under resting conditions or mild (local) infection, it may be perturbed during sepsis or meningitis . Thus, simultaneous measurement of these levels could promote early identification of infection, and may even distinguish between mild infection, systemic infection or meningitis. Currently, manufacturers are rapidly developing Luminex\u00ae technology as an advanced, fast, high-throughput and clinically feasible bedside tool for such an approach.~We hypothesize that incidence rates of neonates with infection in Suriname are high. We further hypothesize that, upon signs of infection, the simultaneous measurement of cAMs and their SEs in serum and CSF discriminates between infected and non-infected neonates. We aim to: 1) identify and follow neonates at the Academic Hospital Paramaribo with signs of infection to establish incidence rates of infection, and 2) investigate diagnostic potential of our proposed biomarker combination in these neonates for infection, type of infection (e.g., local (mild), sepsis or meningitis) and outcomes.", - "NCTID": "NCT02486783" - }, - { - "brief_title": "Safety of and Immune Response to an HIV-1 Subtype C Vaccine (AVX101) in HIV Uninfected Adults", - "phase": "Phase 1", - "drugs": "['AVX101', 'placebo']", - "drugs_list": [ - "AVX101", - "placebo" - ], - "diseases": "['HIV Infections']", - "diseases_list": [ - "HIV Infections" - ], - "enrollment": "96.0", - "inclusion_criteria": "inclusion criteria: \n\n HIV uninfected \n\n At low risk for HIV infection \n\n Willing to receive HIV test results \n\n Good general health \n\n Acceptable methods of contraception for females of reproductive potential \n\n Hepatitis B surface antigen negative \n\n Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV is positive \n\n Meets educational requirements of the study \n\n ", - "exclusion_criteria": ": \n\n HIV vaccines or placebos in prior HIV vaccine trial \n\n Immunosuppressive medications within 168 days prior to first study vaccine administration \n\n Blood products within 120 days prior to first study vaccine administration \n\n Immunoglobulin within 60 days prior to first study vaccine administration \n\n Live attenuated vaccines within 30 days prior to first study vaccine administration \n\n Investigational research agents within 30 days prior to first study vaccine administration \n\n Subunit or killed vaccines within 14 days prior to first study vaccine administration \n\n Allergy treatment with antigen injections within 30 days prior to first vaccine administration \n\n Current tuberculosis prophylaxis or therapy \n\n Serious adverse reaction to a vaccine. A person who had an adverse reaction to pertussis vaccine as a child is not excluded. \n\n Autoimmune disease or immunodeficiency \n\n Active syphilis \n\n Unstable asthma \n\n Type 1 or type 2 diabetes mellitus \n\n Thyroid disease requiring treatment in the past 12 months \n\n Serious angioedema within the past 3 years \n\n Uncontrolled hypertension \n\n Bleeding disorder \n\n Malignancy unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period \n\n Seizure disorder requiring medication within the past 3 years \n\n Asplenia \n\n Mental illness that would interfere with compliance with the protocol \n\n Other conditions that, in the judgment of the investigator, would interfere with the study \n\n Pregnant or breastfeeding", - "brief_summary": "The purpose of this study is to evaluate the safety of and immune response to an alphavirus replicon, HIV-1 subtype C gag vaccine, AVX101, in HIV uninfected adults in the United States, South Africa, and Botswana.", - "NCTID": "NCT00097838" - }, - { - "brief_title": "Rifampicin Explorative PK Study for Tuberculous Meningitis Comparing Oral and Intravenous Preparation", - "phase": "Phase 2", - "drugs": "['Rifampicin intravenous', 'Oral rifampicin']", - "drugs_list": [ - "Rifampicin intravenous", - "Oral rifampicin" - ], - "diseases": "['Tuberculous Meningitis']", - "diseases_list": [ - "Tuberculous Meningitis" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 years or older \n\n Probable/possible tuberculosis meningitis using uniform case definition \n\n Agree to participate in the study \n\n ", - "exclusion_criteria": ": \n\n Patient with antituberculosis treatment within last 2 weeks. \n\n Increase liver function >5x upper limit of normal \n\n Pregnancy", - "brief_summary": "Tuberculous (TB) meningitis is the most severe manifestation of TB infection, leaving up to 50% of patients dead or neurologically disabled. Current treatment is similar to treatment of lung TB, although penetration of some antibiotics into the brain is poor and the immune-pathology of TB meningitis is very different from pulmonary TB. In a recent phase II clinical trial from the investigators group, the first of its kind globally, intensified antibiotic treatment, with moxifloxacin and high dose rifampicin, strongly reduced mortality of TB meningitis.~The investigators aim to examine the effect of intensified antibiotic treatment on mortality and morbidity of TB meningitis in a phase 3 clinical trial, preceded with an explorative pharmacokinetic (PK) study to examine if higher oral doses rifampicin result in exposures similar to the i.v. dose used in our phase 2 trial, since oral rifampicin could be implemented much easier in low-resource settings.", - "NCTID": "NCT01802502" - }, - { - "brief_title": "A Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis (Study P04512)", - "phase": "Phase 3", - "drugs": "['Placebo for MF', 'Placebo for FP', 'Mometasone', 'Fluticasone']", - "drugs_list": [ - "Placebo for MF", - "Placebo for FP", - "Mometasone", - "Fluticasone" - ], - "diseases": "['Perennial Allergic Rhinitis']", - "diseases_list": [ - "Perennial Allergic Rhinitis" - ], - "enrollment": "351.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with perennial allergic rhinitis meeting all of the followings. \n\n Patients with symptoms of perennial allergic rhinitis, the severity of which is moderate or severer according to the severity grading provided in the Guidelines for the Management of Allergic Rhinitis in Japan (partly modified) with the 4-nasal symptom score of 4 or over at informed consent and during the pre-treatment observation period \n\n Patients with positive reaction to the eosinophil count in nasal discharge or nasal challenge test in addition to the skin test or specific IgE antibody test \n\n Outpatients aged 16 years or over at informed consent \n\n Patients in either sex \n\n Patients (or their legal representatives in case of patients aged under 20 years) capable of giving written informed consent \n\n Patients capable of recording nasal allergy diary every day \n\n ", - "exclusion_criteria": ": \n\n Patients with a complication of tuberculous diseases or lower respiratory tract infections, and those with a complication of otorhinolaryngeal infections(acute upper respiratory tract inflammation, acute laryngopharyngitis, acute tonsillitis, etc.) requiring treatments judged by the investigator (subinvestigator) at the time of enrollment to randomization \n\n Patients with a complication of infection or systemic mycosis for which no effective antibiotics are available \n\n Patients with a complication of recurrent epistaxis \n\n Patients with uncured nasal septal ulcer, operated nose or nasal trauma. \n\n Patients with a history of hypersensitivity to steroids and any ingredients of the study drugs \n\n Pregnant, lactating or possibly pregnant patients or the patients who themselves or whose partners wish to become pregnant during the study \n\n Patients with severe hepatic or renal disorder, heart or blood disease, diabetes mellitus, hypertension, or other serious complication, suffering from problems with systemic condition \n\n Patients who have pollens as multiple allergens and the period from 7 days before enrollment to randomization to completion of the treatment period coincides with the period of scattering of relevant pollens \n\n Patients with a complication of vasomotor rhinitis or eosinophilic rhinitis \n\n Patients with a complication of a nasal disease (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, or septal deviation) which may interfere with efficacy evaluation of the study drugs \n\n Patients with a complication of a disease (acute upper respiratory tract inflammation, acute laryngitis or acute tonsillitis, etc.) of severity affecting nasal symptoms within 7 days before enrollment \n\n Patients who have previously received MF nasal spray \n\n Patients who used FP nasal spray within 28 days before initiation of the pre-treatment observation period (7 days before enrollment to randomization) \n\n Patients who have participated in clinical trials of other investigational product(s) within 120 days (4 months) before obtaining informed consent or participating at present \n\n Patients in whom prior medication expected to be effective for allergic rhinitis was not drawn long enough before initiation of treatment with the investigational product or the preceding medication cannot be withdrawn \n\n Patients who are being treated with specific desensitization therapy or nonspecific allassotherapy or in whom such the therapy was withdrawn within 90 days (3 months) before obtaining informed consent (except for patients receiving the maintenance therapy at present in whom the therapy began more than 180 days (6 months) before obtaining the informed consent) \n\n Other patients whom the investigator or the subinvestigator judged to be inappropriate for participation in the present study", - "brief_summary": "This study was conducted to see if mometasone nasal spray is efficaceous for the treatment of perennial allergic rhinitis. Patients will be randomized to active mometasone, placebo mometasone, active fluticasone, or placebo fluticasone.", - "NCTID": "NCT00783224" - }, - { - "brief_title": "Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder (PTSD)", - "phase": "Phase 2", - "drugs": "['paroxetine', 'placebo']", - "drugs_list": [ - "paroxetine", - "placebo" - ], - "diseases": "['Post-Traumatic Stress Disorder', 'Stress Disorders, Post-Traumatic']", - "diseases_list": [ - "Post-Traumatic Stress Disorder", - "Stress Disorders", - "Post-Traumatic" - ], - "enrollment": "5.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who are primarily diagnosed with PTSD (Posttraumatic Stress Disorder: 309.81) using DSM-IV-TR criteria. The CAPS-DX (Clinician-Administered PTSD Scale-DX) and M.I.N.I. (The Mini International Neuropsychiatric Interview, Japanese version 5.0.0. [2003]) will be used for diagnosis \n\n Pathologic condition: Patients who experienced a motor vehicle accident (MVA) with severe or potential severe physical injury more than 3 months ago but less than 12 months ago \n\n Patients aged 20 and <65 at the time of signing the Informed consent \n\n Male and female patients \n\n Inpatient/outpatient status: Both are permitted \n\n Patients who are able to give written informed consent in person (i.e., patients who are capable of giving written informed consent on their own) \n\n Patients whose combined score of the CAPS-SX standard B, C, and D is over 50 \n\n ", - "exclusion_criteria": ": \n\n Patients primarily diagnosed with a DSM-IV-TR Axis I disorder other than PTSD (e.g. major depressive disorder, dysthymic disorder, specific phobia [simple phobia], obsessive-compulsive disorder, panic disorder, etc.) within 6 months of week -4 (start of baseline phase) \n\n Patients presenting with a current major depressive episode that preceded the diagnosis of PTSD \n\n Patients receiving disability payments due to PTSD or other psychiatric diseases \n\n Patients currently engaged in compensation litigation whereby personal gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders \n\n Patients who meet the DSM-IV-TR criteria for substance abuse or dependence (alcohol or drugs) within 6 months of Week -4 (start of baseline phase) \n\n Patients with history of a suicide attempt within 6 months before Week -4 (start of baseline phase), or have, in the opinion of the investigator, C. high risk of suicide according to the MINI at Week -4 \n\n Patients who are pregnant, lactating or of childbearing potential and are likely to become pregnant \n\n Patients receiving electro-convulsive therapy (ECT) prior to Week -4 (start of baseline phase) \n\n Patients receiving another investigational product within 12 weeks before Week -4 (start of baseline phase) \n\n Patients with a history or complication of manic psychosis \n\n Patients with a history or complication of convulsive disorder (epilepsy, etc.) \n\n Patients with a diagnosis or complication of a cognitive disorder (MMSE <=24 points) \n\n Patients with a history and complication of serious cerebral organic disorder. (e.g. cerebrovascular disorder, meningitis, degenerative disease and other neurological disorders and seizures; however, bleeding in the upper arachnoid membrane should not be excluded) \n\n Patients unable or unwilling to undergo the fMRI procedure (e.g., cerebrovascular clipping surgery, pacemaker, any internal metals with magnetism, and claustrophobia) \n\n Patients with glaucoma \n\n Patients with a known tendency for bleeding or those with predisposing conditions \n\n Patients with a history of hypersensitivity to paroxetine \n\n Patients with serious physical symptoms (cardiac, hepatic and renal dysfunction, or hematopoietic dysfunction, etc.). For seriousness, Grade 3 of Criteria for seriousness of adverse reactions to drugs, etc. (Yakuan No.80) is used as an index \n\n Patients with a history or complication of cancer or malignant tumour \n\n Patients with chronic hepatitis type B and/or C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody \n\n Others whom the investigator or sub-investigator considers ineligible for or unable to participate in the investigation \n\n Criteria at Week 0 (start of Treatment Phase): \n\n Subjects whose drug compliance rate for Drug 1 (Run-in Phase placebo) is <80% between Week -4 and Week 0; \n\n Subjects whose CAPS-SX total score of the standard B, C, and D at Week 0 varied by 25% or more compared with those at Week -2", - "brief_summary": "This is a single-blind, placebo-controlled, parallel group study to evaluate the efficacy of BRL29060A (paroxetine hydrochloride hydrate, hereafter paroxetine) administered orally over the dose range of 20 mg to 50 mg once daily after supper for 12 weeks in Japanese patients with posttraumatic stress disorder (PTSD) as assessed by the change from baseline in CAPS-SX total score. Also the effect of paroxetine on regional cerebral blood flow (rCBF) induced by subthreshold emotional arousing (or symptom stimulating) tasks will be determined using functional magnetic resonance imaging (fMRI) for exploratory assessment of the correlation between the change in rCBF and the efficacy.~The sample size is 30 subjects. The study period consists of 4 weeks of run-in phase, 12 weeks of treatment phase, 0-3 weeks of taper phase and follow-up examination at 2 weeks after the last dose, for a total of 18-21 weeks.~Subjects will visit the clinic at the start of run-in phase, Week -2, the start of treatment phase, Weeks 2, 4, 6, 8 and 12 of treatment, and follow-up examination.", - "NCTID": "NCT00557622" - }, - { - "brief_title": "Study Evaluating Pneumococcal Meningitis in the Paediatric Population in Spain Four Years After the Marketing of Prevenar.", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pneumococcal Meningitis']", - "diseases_list": [ - "Pneumococcal Meningitis" - ], - "enrollment": "160.0", - "inclusion_criteria": "inclusion criteria: \n\n All children from 0 up to 14 years with diagnosis of confirmed or probable pneumococcal meningitis or with diagnosis of suspected bacterial meningitis without bacterial or viral isolation will be included into the study.", - "exclusion_criteria": "", - "brief_summary": "The aim of this study is to determine the prevalence of pneumococcal meningitis in the paediatric population in Spain four years after the marketing of Prevenar. Also secondary objectives are: 1) to determine the clinical characteristics and outcome of the disease; and 2) to determine serotypes and antibiotic resistance patterns.", - "NCTID": "NCT00227214" - }, - { - "brief_title": "Safety Study of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine for Meningitis", - "phase": "Phase 1", - "drugs": "['meningococcal meningitis conjugate vaccine, quadrivalent', 'meningococcal meningitis conjugate vaccine, quadrivalent']", - "drugs_list": [ - "meningococcal meningitis conjugate vaccine", - "quadrivalent", - "meningococcal meningitis conjugate vaccine", - "quadrivalent" - ], - "diseases": "['Meningococcal Meningitis', 'Meningococcal Infections']", - "diseases_list": [ - "Meningococcal Meningitis", - "Meningococcal Infections" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Willing and able to give informed consent and comply with all aspects of the evaluation after the nature of the study is explain \n\n For the purpose of this study, a healthy volunteer is defined as healthy male or female, with no significant chronic conditions \n\n Age 18 to 50 years old \n\n Either gender. Abstinence or use of contraception during the eight weeks after vaccination will be required for non menopausal (< two years post-menopause) or non surgically sterile women \n\n Persons with antibody titer(s) of <2 \u00b5g/mL to serogroup(s) A, C, Y, or W-135 polysaccharides as measured by ELISA \n\n ", - "exclusion_criteria": ": \n\n Age less than 18 years or over 50 years. \n\n History of Guillain-Barr\u00e9 syndrome (GBS). \n\n Pregnancy or lactation. \n\n History of meningococcal meningitis. \n\n History of invasive (clinical or laboratory diagnosis) meningococcal disease. \n\n History of meningococcal meningitis vaccination. \n\n Screening laboratory abnormalities (in the opinion of the Investigator) that would raise safety concerns for participation in the study. \n\n Use of immunosuppressive drugs within 30 days prior to study enrollment, not including topical or inhaled steroids/cytotoxic agents. \n\n History of anaphylactic shock, asthma, urticaria, or other allergic or hypersensitivity reactions following vaccination. \n\n History of severe allergic disorders or autoimmune connective tissue disorders, including rheumatoid arthritis. A high sensitivity C-Reactive Protein (CRP) test at screening will be used as part of the assessment of autoimmune disorders by the Principal Investigator. \n\n Use of systemic antibiotics within 72 hours prior to study enrollment. \n\n History of cirrhosis. \n\n Positive results of testing for HepBsAg, Hepatitis C or HIV-1 or HIV-2 antibodies. \n\n Positive results of drug screen (amphetamine, THC, cocaine). \n\n Persons with antibody titer(s) of >2 \u00b5g/mL to serogroup (s) A, C, Y, or W 135 as measured by ELISA. \n\n Unable to understand all of the study requirements. \n\n Prisoners. \n\n Participation in a clinical trial in the last three months. \n\n History of any serious chronic medical or psychiatric illnesses. \n\n History of significant head trauma, alcohol or substance abuse or other medical illnesses that could cause a neurological deficit (e.g., cerebro-vascular disease) . \n\n Chronic medication use that, in the opinion of the Investigator, may influence or bias the clinical outcome of the trial. \n\n Individuals will be excluded from participation in this trial if they are judged by the Principal Investigator as having a significant impairment in their capacity for judgment or reasoning that compromise their ability to make decisions in their best interest.", - "brief_summary": "The purpose of this study is to evaluate the safety of a new conjugate vaccine, NmVac4-A/C/Y/W-135-DT, compared to the safety of a similar, licensed meningococcal A/C/Y/W-135-DT conjugate vaccine. The investigators will also evaluate the production of antibodies to of NmVac4-A/C/Y/W-135-DT\u2122 conjugate vaccine compared to the licensed vaccine, as a measure of vaccine effectiveness.", - "NCTID": "NCT01482052" - }, - { - "brief_title": "Norepinephrine Transporter Availability in PTSD", - "phase": "Phase 1", - "drugs": "['[C-11]MENET']", - "drugs_list": [ - "[C-11]MENET" - ], - "diseases": "['Posttraumatic Stress Disorder']", - "diseases_list": [ - "Posttraumatic Stress Disorder" - ], - "enrollment": "9.0", - "inclusion_criteria": "inclusion criteria: \n\n PTSD as determined by the Structural Clinical Interview for DSMIV (SCID) interview of PTSD and the Clinical Administered PTSD Scale (CAPS). \n\n Veteran with history of active duty service and currently discharged from active duty service \n\n Free of psychotropic medication for four weeks before the study \n\n ", - "exclusion_criteria": ": \n\n History of shrapnel or other foreign bodies which would preclude MRI scanning \n\n Meningitis \n\n Traumatic brain injury \n\n Neurological disorder or organic mental disorder \n\n History of loss of consciousness \n\n Current or lifetime history of alcohol abuse or substance abuse or dependence base on the SCID \n\n Current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia based on the SCID \n\n History of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness \n\n Evidence of a major or neurological illness on physical examination or as a result of laboratory studies \n\n positive urine toxicology screen \n\n Current steroid use", - "brief_summary": "The objective of this proposal is to collect pilot data to characterize the binding of [11C]MENET in combat-exposed war veterans with posttraumatic stress disorder (PTSD). Approximately two hundred thousand veterans will be returning stateside upon the end of combat operations in Iraq, and 13% of returning veterans will have PTSD. 15% of all war veterans will develop chronic PTSD symptoms requiring a lifetime of mental health care. Little is known about the dysregulation of PTSD veteran's neurochemical state including the noradrenergic system which plays a primary role in memory and stress response. This includes heightened anxiety, fear and hyperarousal symptoms characteristic of PTSD. The noradrenergic system is a concentration of neurons in the brainstem nucleus, locus coerulues, that have projections to the amygdale and prefrontal cortex. The norepinephrine transporter (NET) is responsible for regulating and terminating noradrenergic transmission, and is a specific marker for neuronal integrity. Hyperactivity of the noradrenergic system up-regulates NET protein. An unresolved problem in studying the noradrenergic system is identification of suitable radiopharmaceutical to non-invasively measure alterations in the density of NET. The investigators propose to address this challenge by using positron emission tomography (PET) to measure stress-induced changes in NET expression in combat-exposed war veterans with PTSD. The central hypothesis of this proposal is that war veterans with PTSD have an up-regulation of NET in the locus coerulues resulting from hyperactivity of the noradrenergic system compared to healthy controls. Through a series of experiments, the investigators will determine the in vivo binding characteristics of [11C]MENET. The investigators will use this information to optimally design an experimental protocol to measure the availability of NET in a pilot group of combat-exposed war veterans with PTSD. The aims of this proposal are: 1) Measure the uptake kinetics and whole brain distribution of [11C]MENET in combat-exposed veterans with PTSD and healthy controls, 2) Develop a quantitative kinetic model of [11C]MENET uptake to calculate the NET availability in brain. The subjects undergoing imaging in this work will be recruited by Dr. J. Douglas Bremner (Co-Investigator) at Emory University and Atlanta Veteran Affairs Hospital. Our long-term goal is to develop a longitudinal study framework to assess the NETs dysregulation during onset of PTSD as well as its transition to chronic lifetime PTSD.", - "NCTID": "NCT01799837" - }, - { - "brief_title": "Persistence of Bactericidal Antibodies in Adults Who Received a Booster Dose of Menactra\u00ae Approximately 4 Years Earlier", - "phase": "Phase 4", - "drugs": "['Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine']", - "drugs_list": [ - "Meningococcal (Groups A", - "C", - "Y", - "and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine" - ], - "diseases": "['Meningitis', 'Meningococcal Meningitis', 'Meningococcal Infections']", - "diseases_list": [ - "Meningitis", - "Meningococcal Meningitis", - "Meningococcal Infections" - ], - "enrollment": "110.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged \u2265 18 years on the day of inclusion \n\n Received booster dose of Menactra vaccine in trial MTA77 \n\n Informed consent form has been signed and dated \n\n Able to attend the scheduled visit and to comply with all trial procedures. \n\n ", - "exclusion_criteria": ": \n\n Participation at the time of trial enrollment (or in the 4 weeks preceding trial enrollment) in another clinical trial investigating a vaccine, drug, medical device, or medical procedure \n\n Receipt of any meningococcal vaccine, including serogroup B meningococcal vaccine, after receipt of the booster dose of Menactra vaccine administered in trial MTA77 \n\n Receipt of immune globulins, blood or blood-derived products in the past 3 months \n\n Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) \n\n History of meningococcal infection, confirmed either clinically, serologically, or microbiologically \n\n Bleeding disorder, thrombocytopenia, or receipt of anticoagulants contraindicating venipuncture at the discretion of the Investigator \n\n Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily \n\n Current alcohol abuse or drug addiction \n\n Any illness that, in the opinion of the Investigator, might interfere with trial conduct or trial results \n\n Receipt of oral or injectable antibiotic therapy within 72 hours prior to the blood draw. (A prospective subject should not be included in the trial until 72 hours has passed.) \n\n Identified as an Investigator or employee of the Investigator or trial center with direct involvement in the proposed trial, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed trial.", - "brief_summary": "The aim of this study is to provide information on the persistence of bactericidal antibodies following Menactra booster vaccination in study MTA77 ( NCT01442675).~Objective:~To evaluate the persistence of antibody responses (determined by a serum bactericidal assay using human complement (SBA-HC)) approximately 4 years after the administration of a booster dose of Menactra vaccine in trial MTA77", - "NCTID": "NCT02633787" - } - ], - "1": [ - { - "brief_title": "Association Between Craniofacial Fractures and Brain Injuries: Diagnostic and Therapeutic Considerations", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Brain Injuries', 'Skull Fractures']", - "diseases_list": [ - "Brain Injuries", - "Skull Fractures" - ], - "enrollment": "1000.0", - "inclusion_criteria": "inclusion criteria: \n\n Severe traumatic brain injury, GCS 8 or less and/or Craniofacial fracture \n\n ", - "exclusion_criteria": ": \n\n Died before admitted to hospital", - "brief_summary": "This study evaluates the association between traumatic brain injuries and craniofacial or/and skull fractures. Purpose is to find out the amount of missed diagnoses and improve primary diagnostics of trauma patients.", - "NCTID": "NCT02418169" - }, - { - "brief_title": "TASALL - TachoSil\u00ae Against Liquor Leak", - "phase": "Phase 3", - "drugs": "['TachoSil\u00ae', 'Current Practice']", - "drugs_list": [ - "TachoSil\u00ae", - "Current Practice" - ], - "diseases": "['Cerebrospinal Fluid Leaks']", - "diseases_list": [ - "Cerebrospinal Fluid Leaks" - ], - "enrollment": "726.0", - "inclusion_criteria": "Main inclusion criteria (Positive response): \n\n \u2022 Is the surgical approach/procedure consistent with skull base surgery? I.e. one of the following: \n\n Lateral approach to the foramen magnum: Far lateral, extreme lateral, anterolateral, posterolateral \n\n Approach to the jugular foramen: Infratemporal, juxta condylar, transjugular \n\n Approach to the cerebello pontine (CP) angle and petrous apex retrosigmoid \n\n Approach to the middle fossa: Subtemporal (+/- petrous apex drilling), pterional approach (any fronto temporal approach +/- orbitozygomatic deposition) \n\n Approach to the anterior fossa: Subfrontal (uni or bilateral) \n\n Approach to the midline posterior fossa \n\n Main ", - "exclusion_criteria": " (Negative response): \n\n Has the patient been subject to neurosurgery involving opening of the dura mater within the last 3 months? \n\n Is the patient anticipated to undergo any additional neurosurgery involving opening of the dura mater which may affect the efficacy evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the Efficacy Follow-up Week 7\u00b11 week? \n\n Is the patient anticipated to undergo any additional neurosurgery involving opening of the dura mater which may affect the safety evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the Safety Follow-up Week 28\u00b12 weeks? \n\n The surgical approach/procedure is consistent with any transcranial or transfacial or combination of transcranial - transfacial approaches with wide defect in the skull base? I.e. any of the following: \n\n Trans basal approach \n\n Total petrosectomy \n\n Trans facial approach \n\n Trans sphenoidal approach \n\n Endoscopic procedures \n\n Trans oral approach (and any extension: Le Fort, mandibulotomy) \n\n The surgical approach is consistent with one of the following approaches? \n\n Translabyrinthine approach \n\n Retrolabyrinthine approach \n\n Transcochlear (limited transpetrosal) approach \n\n Did the arachnoid membrane and the CSF containing system remain intact during surgery? \n\n Does the patient have more than one dura opening (not including dura openings from extraventricular or lumbar drains)? \n\n Has TachoSil, fibrin or polymer sealants been used during the current surgery prior to randomization?", - "brief_summary": "The primary objective is to demonstrate superiority of TachoSil\u00ae compared to current practice as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing must be evaluated post-operatively. The secondary objective is to evaluate the safety of TachoSil\u00ae as an adjunct in sealing the dura mater.~The trial population will consist of 726 randomised (1:1) patients elected for skull base surgery. The trial duration consists of screening, surgery, efficacy follow-up after 7\u00b11 weeks and safety follow-up 28\u00b12 weeks after surgery.", - "NCTID": "NCT01355627" - }, - { - "brief_title": "Evidence Based Diagnostics and Treatment Planning Solution for Traumatic Brain Injuries", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Traumatic Brain Injury']", - "diseases_list": [ - "Traumatic Brain Injury" - ], - "enrollment": "396.0", - "inclusion_criteria": "inclusion criteria: \n\n Severe or moderate brain trauma subjects with need of ICU care: \n\n Glasgow Coma Score (GCS) \u2264 8 after the primary stabilization has been performed in the field (= patient not hypoxic or hypotensive) and at least 30 min interval from the moment of injury. \n\n GCS 9 - 13 and the patient is deteriorating \n\n The patient has GCS \u2264 13 and has other injuries, which require interventions for hemodynamic or ventilatory incidents \n\n The patient is in urgent need of neurosurgery (craniotomy, impression skull fracture, severe haemorrhagic contusion, or ICP measurement) \n\n Moderate or mild brain trauma not in need of ICU care: \n\n - All other patients who fulfil the diagnostic criteria for an acute TBI but without any ", - "exclusion_criteria": " defined below \n\n ", - "brief_summary": "Adult patients, age \u2265 18 years, with clinically diagnosed mild, moderate or severe brain trauma will be asked to participate in the study. This prospective database will consist of 400 subjects with TBI, 200 from both TUCH and Cambridge Addenbrooke's Hospital. In addition, 100 controls will be recruited, with 50 from both centres.This study is a prospective clinical observational study with detailed data collecting. All patients will be treated according to the accepted, standardized, existing guidelines that are based on national and international recommendations. New treatment interventions will NOT be evaluated during the data acquisition for this study.", - "NCTID": "NCT02021877" - }, - { - "brief_title": "Diagnostic Algorithm in Patients With Minor Head Injury", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Minor Head Injury', 'Traumatic Brain Injury']", - "diseases_list": [ - "Minor Head Injury", - "Traumatic Brain Injury" - ], - "enrollment": "12500.0", - "inclusion_criteria": "inclusion criteria: \n\n head injury, nausea, vomiting \n\n ", - "exclusion_criteria": ": \n\n no head injury", - "brief_summary": "The objective of this prospective study is to evaluate the reliability of plain x-rays vs.cranial computed tomography as a screening method for skull fractures and its prognostic value for intracranial bleeding (ICB).", - "NCTID": "NCT00452036" - }, - { - "brief_title": "Bedside Sedation for the Prevention of Post Dural Puncture Headache", - "phase": "Phase 2", - "drugs": "['Midazolam']", - "drugs_list": [ - "Midazolam" - ], - "diseases": "['Post Dural Puncture Headache']", - "diseases_list": [ - "Post Dural Puncture Headache" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n 18-50 years old \n\n Undergoing diagnostic LP for any indication for the first time \n\n ", - "exclusion_criteria": ": \n\n COPD \n\n Any known chronic pulmonary disease \n\n Acute febrile illness \n\n Persistent headaches \n\n Known sensitivity to Benzodiazepines \n\n Current or prior substance abuse disorder \n\n Cognitive decline", - "brief_summary": "Dural or lumbar puncture (LP), the passing of a needle into the space of the spinal cord, is a common procedure in everyday clinical practice. The most common use for LP is to measure the spinal fluid pressure and sample spinal fluid for laboratory analysis. However, it is also used for therapeutic purposes, such as administering chemotherapy or spinal anesthesia.~A notorious side effect of dural puncture is headache that ranges from mild to debilitating and may last for several days following the procedure. Among diagnosed patients, 39% experience at least 1 week of impaired ability to perform activities of daily living. The likelihood of developing a headache after dural puncture depends on a number of factors. As fluid leak is assumed to be the culprit mechanism in this headache strategies to minimize the leak seem to offer the best path to lowering the incidence of headache after diagnostic LP, the commonest clinical context of dural puncture in medical practice.~Lumbar puncture is a highly stressful event for most patients. As both pain and anxiety cause adrenergic stimulation, they also cause an increase in ICP. We believe that this mild increase in ICP, occurring before the puncture as well as during the puncture itself may exacerbate the pressure difference between the CSF space and the epidural space and so worsen the CSF leak Furthermore, this excess pressure, although mild, might cause the dural puncture hole to widen slightly and so further augment the leak and possibly even prolong it. Furthermore, the very anticipation of pain causes a rise in neurotransmitters that may cause a sensitization effect and worsen pain. This increase in adrenergic drive as well as the sensitization to pain can be effectively blunted by the periprocedural use of mild IV sedation. Benzodiazepines, with their sedative-hypnotic qualities are well suited for this task.~This study aims to test the effect of mild peri-procedural IV sedation using Midazolam on the rates of headache after diagnostic LP.~Patients undergoing a diagnostic LP will be randomized into two groups. Group 1 will undergo the procedure as routinely practiced. Group 2 will be given Midazolam IV 10-5 minutes prior to the procedure and undergo the same diagnostic procedure. All patients in the study will remain under observation in the hospital for at least 6 hours.~Patients will be evaluated for headache and specifically for headache. Clinical follow up will continue for 72 hours by administering a short questionnaire over the telephone.", - "NCTID": "NCT01503788" - }, - { - "brief_title": "Cerebrospinal Fluid Drainage (CSFD) in Acute Spinal Cord Injury", - "phase": "", - "drugs": "['CSFD and elevation of MAP', 'Maintenance of MAP']", - "drugs_list": [ - "CSFD and elevation of MAP", - "Maintenance of MAP" - ], - "diseases": "['Spinal Cord Injury']", - "diseases_list": [ - "Spinal Cord Injury" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged 18-75 years inclusive; \n\n Diagnosis of acute SCI; \n\n Injury is less than 24 hours old; \n\n ISNCSCI Impairment Scale Grade A, B or C based upon first ISNCSCI evaluation after arrival to the hospital; \n\n Neurological level of injury between C4-C8 based upon first ISNCSCI evaluation after arrival to the hospital; \n\n Women of childbearing potential must have a negative serum \u03b2-hCG pregnancy test or a negative urine pregnancy test; \n\n Patient is willing to participate in the study; \n\n Informed consent document signed by patient or witnessed informed consent document; \n\n No contraindications for study treatment(s); \n\n Able to cooperate in the completion of a standardized neurological examination by ISNCSCI standards (includes patients who are on a ventilator). \n\n ", - "exclusion_criteria": ": \n\n Injury arising from penetrating mechanism; \n\n Significant concomitant head injury defined by a Glasgow Coma Scale (GCS) score < 14 with a clinically significant abnormality on a head CT (head CT required only for patients suspected to have a brain injury at the discretion of the investigator); \n\n Pre-existing neurologic or mental disorder which would preclude accurate evaluation and follow-up (i.e. Alzheimer's disease, Parkinson's disease, unstable psychiatric disorder with- hallucinations and/or delusions or schizophrenia); \n\n Prior history of SCI; \n\n Recent history (less than 1 year) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation, in the opinion of the investigator; \n\n Is a prisoner; \n\n Participation in another clinical trial within the past 30 days; \n\n Acquired immune deficiency syndrome (AIDS) or AIDS-related complex; \n\n Active malignancy or history of invasive malignancy within the last five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitely treated. Patients with carcinoma in situ of the uterine cervix treated definitely more than 1 year prior to enrollment may enter the study.", - "brief_summary": "The purpose of this Phase IIB randomized controlled trial is to evaluate the safety and efficacy of CSFD and to provide a preliminary clinical efficacy evaluation of the combination of CSFD and elevation of mean arterial pressure (MAP) in patients with acute spinal cord injury (SCI). The objectives of the trial are to evaluate (i) efficacy of reducing intrathecal pressure (ITP) by CSFD in patients with acute SCI; (ii) preliminary efficacy of combination of CSFD and elevation of MAP compared to elevation of MAP alone in improving neurologic motor outcomes in patients with acute SCI; and, (iii) safety of intensive CSFD in acute SCI patients.", - "NCTID": "NCT02495545" - }, - { - "brief_title": "Measure of Cerebrospinal Fluid (CSF) Pressure Variation With Patient Positioning", - "phase": "", - "drugs": "['Myelogram']", - "drugs_list": [ - "Myelogram" - ], - "diseases": "['Back Pain']", - "diseases_list": [ - "Back Pain" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Need a lumbar or cervical myelogram as part of routine care. \n\n ", - "exclusion_criteria": ": \n\n Not needing a myelogram in the cervical or lumbar spine.", - "brief_summary": "This is a study looking at pressure changes in the fluid that surrounds the spine when a person is positioned in 2-3 different ways.", - "NCTID": "NCT00231374" - }, - { - "brief_title": "The EPIC Project: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines", - "phase": "", - "drugs": "['The National Prehospital TBI Management Guidelines']", - "drugs_list": [ - "The National Prehospital TBI Management Guidelines" - ], - "diseases": "['Brain Injuries, Traumatic', 'Injuries, Acute Brain', 'TBI (Traumatic Brain Injury)']", - "diseases_list": [ - "Brain Injuries", - "Traumatic", - "Injuries", - "Acute Brain", - "TBI (Traumatic Brain Injury)" - ], - "enrollment": "26873.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults and children with physical trauma who: 1) are transported directly to or are transferred to a level I TC by participating EMS agencies, 2) have hospital diagnosis(es) consistent with TBI (either isolated or multisystem trauma that includes TBI), and 3) meet at least one of the following definitions for severe TBI: a) last prehospital GCS or first hospital/trauma center GCS <9; b) AIS-head of \u22653, c) CDC Barell Matrix-Type 1, d) undergo prehospital ETI, nasal intubation, or cricothyrotomy. \n\n ", - "exclusion_criteria": ": \n\n Patients with brain injury from: 1) non-mechanical mechanisms (e.g., drowning); 2) choking, primary asphyxiation, or strangulation; 3) environmental injury (e.g., hyperthermia); 4) poisoning (e.g., drug overdose, carbon monoxide, insecticides); 5) intracranial hemorrhage of non-traumatic origin; 6) other non-traumatic, acute neurological emergencies (e.g., bacterial meningitis).", - "brief_summary": "Evaluation of the impact (on survival and other outcomes) of implementing the Brain Trauma Foundation/National Association of EMS Physicians Traumatic Brain Injury (TBI) guidelines in the prehospital EMS systems throughout the state of Arizona.", - "NCTID": "NCT01339702" - }, - { - "brief_title": "Cerebrospinal Fluid (CSF) Drainage and Cytokine Profiling in the Treatment of Acute Spinal Cord Injury (SCI)", - "phase": "", - "drugs": "['CSF Drainage', 'No CSF Drainage']", - "drugs_list": [ - "CSF Drainage", - "No CSF Drainage" - ], - "diseases": "['Spinal Cord Injuries']", - "diseases_list": [ - "Spinal Cord Injuries" - ], - "enrollment": "31.0", - "inclusion_criteria": "inclusion criteria: \n\n Injured subjects: \n\n Complete or incomplete acute SCI between C0 and T11 \n\n Admitted within 48 hours of injury \n\n Undergoing spinal decompressive surgery \n\n Undergoing lumbar puncture for spinal anesthetic or myelography \n\n Neurologically intact \n\n ", - "exclusion_criteria": ": \n\n Pre-existing neurodegenerative disorder \n\n Associated head or spine injury", - "brief_summary": "The overall purpose of this pilot study is to evaluate CSF drainage as a potential neuroprotective strategy after acute spinal cord injury (SCI).", - "NCTID": "NCT00135278" - }, - { - "brief_title": "DuraSeal Sealant Post Market Study", - "phase": "", - "drugs": "['DuraSeal Dural Sealant System', 'Standard of Care']", - "drugs_list": [ - "DuraSeal Dural Sealant System", - "Standard of Care" - ], - "diseases": "['Elective Cranial Procedures With Dural Incision']", - "diseases_list": [ - "Elective Cranial Procedures With Dural Incision" - ], - "enrollment": "237.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient is between 18 and 75 years of age \n\n Patient is scheduled for an elective cranial procedure that entails a dural incision \n\n Evidence of intraoperative non-watertight closure", - "exclusion_criteria": "", - "brief_summary": "DuraSeal Dural Sealant has been approved as a dural sealant by the FDA for use in cranial and spinal procedures. This study was completed to further evaluate the safety of the DuraSeal Sealant in a post-approval setting as compared to control (defined as methods typically employed by surgeons to seal the dura).", - "NCTID": "NCT00704340" - } - ], - "2": [ - { - "brief_title": "Concussion and Post Traumatic Stress in Traumatic Brain Injury", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Concussion', 'Stress Disorders, Post-Traumatic']", - "diseases_list": [ - "Concussion", - "Stress Disorders", - "Post-Traumatic" - ], - "enrollment": "1.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients will be recruited from the Bellevue Hospital Emergency Services (Emergency Department and Trauma Bay) or from among inpatient populations at Bellevue Hospital. They will need to be consentable and able/willing to participate and meet criteria for distribution into one of the three subject populations (structural TBI, non-structural TBI, injured/non-TBI) described here: \n\n mild to moderate structural traumatic brain injury (TBI) as evidenced by CT scan demonstrating the presence of hemorrhage (subdural, epidural, subarachnoid or intraparenchymal), brain contusion, or skull fracture. \n\n non-structural TBI(concussion), meaning no signs of structural injury on imaging; however, they complain of usual brain injury symptoms such as headache, dizziness, cognitive impairments, etc., A subject with a traumatically induced physiological disruption of brain function, manifested by >1 of the following: \n\n Any period of loss of consciousness (LOC). \n\n Any loss of memory for events immediately before or after the accident. \n\n Any alteration in mental state at the time of accident (i.e. feeling dazed, disoriented, or confused). \n\n Focal neurological deficit(s) that may or may not be transient, but where the severity of the injury does not exceed the following: \n\n Loss of consciousness of approximately 30 minutes or less \n\n After 30 minutes, an initial Glasgow Coma Scale (GCS) of 13-15 \n\n Posttraumatic amnesia (PTA) not greater than 24 hours. \n\n Non-brain injured subjects that have suffered some type of injury such as to the extremities or other parts of the body. The subjects will have sustained a blunt or penetrating trauma such as, to the corpus or extremities (i.e. car accident, falling). \n\n ", - "exclusion_criteria": ": \n\n Subjects that receive minor penetrating trauma insufficiently traumatizing to result in sufficient sequelae will be excluded. \n\n Subjects suffering burns, anoxic injury or multiple/extensive injuries resulting in any medical, surgical or hemodynamic instability will also be excluded. \n\n Particularly for the purposes of eye tracking all subjects that are blind (no light perception), are missing eyes, do not open eyes will be excluded from the research. \n\n It is pertinent that subjects be able to detect light and have both eyes in order for the eye tracking data to be effective and significant. \n\n Any physical or mental injury or baseline disability rendering task completion difficult will be excluded, also inability to participate in longtitudinal care, or obvious intoxication or blood alcohol level greater than 0.2. \n\n Pregnant individuals and prisoners will also be excluded from the study.", - "brief_summary": "Mild brain injury or concussion affects about four million Americans each year. Some people recover completely while others, especially those with multiple concussions, develop chronic headaches, neurodegenerative diseases and psychiatric disorders. One of the reasons that concussion is difficult to treat is that it is difficult to detect. Radiographic studies such as CT (computed tomography scan) are by definition unrevealing of structural injury in concussed patients. Some MRI (magnetic resonance imaging) sequences may be useful adjuncts in the diagnosis of concussion but even these are not consistently present in all patients with symptoms. Clinical tests for concussion often require baseline studies, and thus are generally reserved for athletes and others at highest risk for concussion.~The investigators have developed a novel eye movement tracking algorithm performed while subjects watch television or a music video that determines whether the eyes are moving together (conjugate) or are subtly not together (disconjugate). The investigators preliminary data shows that people with lesions in their brain or recovering from brain injury have disconjugate gaze that is not detectable by ophthalmologic examination but is detected by our algorithm.", - "NCTID": "NCT02119533" - }, - { - "brief_title": "The EVICEL\u00ae Neurosurgery Phase III Study", - "phase": "Phase 3", - "drugs": "['EVICEL Fibrin Sealant', 'Hydrogel sealant']", - "drugs_list": [ - "EVICEL Fibrin Sealant", - "Hydrogel sealant" - ], - "diseases": "['Cerebrospinal Fluid Leak']", - "diseases_list": [ - "Cerebrospinal Fluid Leak" - ], - "enrollment": "234.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects \u226518 years of age undergoing craniotomy/craniectomy for pathological processes in the supratentorial region or posterior fossa \n\n Subjects or legally authorized representatives must be willing to participate in the study and provide written informed consent. \n\n Surgical wound classification Class I \n\n The cuff of native dura along the craniotomy edge on each side is adequate, based on surgeon's judgment, to facilitate suturing and to allow for sufficient surface area for adherence of the investigational product \n\n Presence of intra-operative cerebrospinal fluid (CSF) leakage following primary dural closure or after Valsalva maneuver \n\n ", - "exclusion_criteria": ": \n\n Subjects with a dural lesion from a recent surgery that still has the potential for CSF leakage. \n\n Chemotherapy within 30-days prior to enrollment or scheduled within 7-days following surgery \n\n Radiation therapy to the head within 30-days prior to enrollment or scheduled within 7-days following surgery \n\n A previous craniotomy/craniectomy within 6 months prior to the study surgery. \n\n Known hypersensitivity to the components of the investigational product. \n\n Subjects with a known allergy to FD&C Blue #1 dye \n\n Subjects with an infection present at the surgical site \n\n Subjects with an infection indicated by any one of the following: clinical diagnosis of infection, fever, positive urine culture, positive blood culture, positive chest X-ray. \n\n Female subjects of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period. \n\n Female subjects who are nursing. \n\n Exposure to another investigational drug or device clinical trial within 30 days prior to enrollment or anticipated in the 60 day follow-up period. \n\n Subjects with severely altered renal or hepatic function, with a compromised immune system or autoimmune disease who can NOT receive hydrogel sealant. \n\n Subjects with penetratring traumatic injuries to the head with damage to the dura \n\n Dural injury during craniotomy/craniectomy that cannot be eliminated by widening the craniotomy/craniectomy to recreate the native dural cuff. \n\n Patient has a gap between durotomy edges of greater than 2mm after primary dural closure. \n\n Approaches that would not allow sutured dural closure such as trans-sphenoidal or trans-labirinthine-/petrosal/-mastoid. Superficial penetration of mastoid air cells are allowed. \n\n Use of implants made of synthetic materials coming into direct contact with dura \n\n Use of other fibrin sealants or PEG-based sealants on the dural closure. Approved fibrin sealants may be used for hemostasis if not in contact with the dura. \n\n Hydrocephalus, except occlusive hydrocephalus caused by posterior fossa pathology or incompletely open cerebrospinal fluid pathways, to be treated during surgical procedure. \n\n Placement of Gliadel Wafers \n\n Intersecting durotomy scars in the surgical path from a previous operation that cannot be completely removed by the planned dural resection. \n\n Two or more separate cranial dural defects, including defects from ventricular cannulation and ventriculo-peritoneal shunting. \n\n Subjects with any other intra-operative findings identified by the surgeon that may preclude the conduct of the study procedure. \n\n Confined bony structures where nerves are present where neural compression may result due to swelling.", - "brief_summary": "The objective of this study is to evaluate the safety and efficacy of EVICEL\u00ae Fibrin Sealant (Human) for use as an adjunct to sutured dural repair in cranial surgery.", - "NCTID": "NCT02457546" - }, - { - "brief_title": "Cases With Traumatic and Non Traumatic Brain Damage Treated in the Intensive Care", - "phase": "", - "drugs": "['type of the brain injury', 'type of the brain injury', 'type of the brain injury', 'type of the brain injury', 'type of the brain injury', 'type of the brain injury']", - "drugs_list": [ - "type of the brain injury", - "type of the brain injury", - "type of the brain injury", - "type of the brain injury", - "type of the brain injury", - "type of the brain injury" - ], - "diseases": "['Brain Injuries']", - "diseases_list": [ - "Brain Injuries" - ], - "enrollment": "135.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients treated in the ICU with the diagnose of traumatic or nontraumatic brain damage, with a more than 24-hour stay. \n\n ", - "exclusion_criteria": ": \n\n Patients admitted less than 24 hour.", - "brief_summary": "Cases of traumatic and nontraumatic brain damage have high rates of morbidity and mortality. In this study of cases being treated in the ICU for a diagnosis of brain damage, it was aimed to evaluate the relationship between mortality and the distribution of reason for and resulting type of brain damage and to determine other factors affecting mortality.", - "NCTID": "NCT02475226" - }, - { - "brief_title": "Vitamin d Levels in Children With Bacterial Meningitis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Bacterial Meningitis']", - "diseases_list": [ - "Bacterial Meningitis" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Probable bacterial meningitis patients: Clinical manifestation (Any person with sudden onset of fever (> 38.5 \u00b0C rectal or 38.0 \u00b0C axillary) and one of the following signs: neck stiffness, altered consciousness or other meningeal sign) with cerebrospinal fluid examination showing at least one of the following: \n\n A. turbid appearance; B.leukocytosis (> 100 cells/mm3); C.leukocytosis (10-100 cells/ mm3) AND either an elevated protein (> 100 mg/dl) or decreased glucose (< 40 mg/dl) \n\n Confirmed bacterial meningitis patients: A case that is laboratory-confirmed by growing (i.e. culturing) or identifying (i.e. by Gram stain or antigen detection methods) a bacterial pathogen (Hib, pneumococcus or meningococcus) in the cerebrospinal fluid or from the blood in a child with a clinical syndrome consistent with bacterial meningitis \n\n ", - "exclusion_criteria": ": \n\n Congenital immunodeficiency patients \n\n HIV patients \n\n Patients with corticosteroid treatment for long time \n\n Patients with disorders in adrenal gland and pituitary gland and hypothalamus \n\n Patients with tuberculosis", - "brief_summary": "The purpose of this study is to determine whether deficiency of Vitamin D has association with outcomes of children with bacterial meningitis.", - "NCTID": "NCT02467309" - }, - { - "brief_title": "Vancomycin Concentration in Cerebrospinal Fluid During Pneumococcal Meningitis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pneumococcal Meningitis']", - "diseases_list": [ - "Pneumococcal Meningitis" - ], - "enrollment": "14.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults (> 18 yr) with suspicion of pneumococcal meningitis requiring intensive care unit \n\n ", - "exclusion_criteria": ": \n\n Allergy to one of the antibiotics used in the study", - "brief_summary": "Adding vancomycin to the antibiotic regimen is recommended for the treatment of pneumococcal meningitis in adults. Use of dexamethasone as adjunct therapy has proved to reduce mortality and neurologic sequelae in adult patients with pneumococcal meningitis. However, use of dexamethasone may impair penetration of vancomycin in cerebrospinal fluid. In a purely observational manner, we thought to measure blood and CSF concentrations of vancomycin in adult patients with pneumococcal meningitis, treated with vancomycin, third-generation cephalosporin and dexamethasone.", - "NCTID": "NCT00162578" - }, - { - "brief_title": "Bacterial Meningitis in Adults: Analysis of the Determinants of Mortality and Neurosensory Sequelae", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Meningitis, Bacterial']", - "diseases_list": [ - "Meningitis", - "Bacterial" - ], - "enrollment": "527.0", - "inclusion_criteria": "inclusion criteria: \n\n Positive CSF culture and/or positive soluble antigens in CSF with or without a cell reaction \n\n Positive PCR in CSF \n\n Purpura fulminant (with or without positive CSF culture) \n\n Positive PCR in blood and/or positive blood culture AND CSF cell reaction. \n\n ", - "exclusion_criteria": ": \n\n Age less than 18 years old \n\n Refusal to participate", - "brief_summary": "Major changes in the epidemiological characteristics of bacterial meningitis have been observed as a result of changes in behaviour, human interventions (use of antibiotics, prophylactic vaccinations), as well as poorly elucidated mechanisms responsible for epidemic outbreaks.~The objective of this study is to identify the determinants of in-hospital mortality of bacterial meningitis in adults.~Hypothesis : the standardized data collection concerning cases of bacterial meningitis in adults with telephone follow-up would allow analysis of the determinants of mortality and neurosensory sequelae, description of the psychosocial impact and proposal of new treatment strategies.", - "NCTID": "NCT01730690" - }, - { - "brief_title": "Neisseria Meningitidis Burden of Disease Study", - "phase": "", - "drugs": "['Data collection', 'CSF samples testing']", - "drugs_list": [ - "Data collection", - "CSF samples testing" - ], - "diseases": "['Streptococcus Pneumoniae', 'Neisseria Meningitidis', 'Haemophilus Influenzae']", - "diseases_list": [ - "Streptococcus Pneumoniae", - "Neisseria Meningitidis", - "Haemophilus Influenzae" - ], - "enrollment": "521.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects who the investigator believes can and will comply with the requirements of the protocol or subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol. \n\n Written informed consent obtained from the subject/from the parent(s)/LAR of the subject. \n\n A male or female subject who visits the hospital with suspected bacterial meningitis. \n\n CSF sample taken as part of routine practice. \n\n ", - "exclusion_criteria": ": \n\n Child in care.", - "brief_summary": "This study aims to provide an estimate of the proportion of suspected cases of bacterial meningitis that are due to N. meningitidis and the serogroup responsible in The Philippines and Vietnam.", - "NCTID": "NCT01730391" - } - ] - }, - { - "patient_id": "sigir-201513", - "patient": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", - "0": [ - { - "brief_title": "Comparison of Ultrasound and Videofluoroscopic Imaging Techniques in Diagnosing Dysphagia in Stroke Patients", - "phase": "", - "drugs": "['No intervention']", - "drugs_list": [ - "No intervention" - ], - "diseases": "['Dysphagia']", - "diseases_list": [ - "Dysphagia" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n The Stroke Center inpatients and outpatients with known or suspected dysphagia can be included for study as well as patients who are admitted specifically for this protocol. (Difficulty swallowing food or pills,changed swallowing ability,coughing or choking when eating, shortness of breath during swallowing, food backing up into the mouth or nasal passage, fever or voice changes after swallowing, pain when swallowing, unexplained loss of weight. \n\n ", - "exclusion_criteria": ": \n\n Patients who are severely demented or severely compromised will be excluded if they do not have sufficient cognitive ability to follow directions. Non-ambulatory patients will be excluded if they cannot be braced or supported within the fluoroscopy unit. Highly agitated individuals will also be excluded if they are unable to remain confined in the equipment.", - "brief_summary": "Introduction Patients with stroke may be silent aspirators or at risk for laryngeal penetration or aspiration because of abnormal oropharyngeal functioning and thus are at risk for aspiration pneumonia and its serious effects. By providing identification of the components of the abnormal swallow, and comparing swallowing across tasks, the investigators may avoid aspiration and can instruct patients on preventative or compensatory swallowing techniques.~Materials and methods~Oral examination-A neurologist and speech pathologist examine the patient's swallowing function. The patient is interviewed about difficulties with food intake, chewing and swallowing during meals.~Ultrasound examination-Ultrasound creates image of areas inside the body using sound waves. With the patient in a sitting position, a 3/4-inch transducer (device for transmitting and receiving sound waves) is placed under the chin to visualize epiglottis movements during swallowing.~Modified barium swallow-While standing or sitting, the patient swallows 1/2 teaspoon of flavored barium (a radioactive substance) six times (a total of 3 teaspoons), while the tongue and pharynx (tube leading from the mouth to the esophagus) are scanned and videotaped at the same time epiglottis movement will be trace with ultrasound. The barium is given in three consistencies-thin, medium and thick (pudding-like).~The investigators will study the oral, pharyngeal and upper esophageal phases of swallow using videofluoroscopy and correlate with ultrasound tracing of epiglottis movement in patients with stroke conditions. Most of the previous studies of swallowing have utilized diagnostic imaging technique to provide a complete swallowing assessment, but limited capabilities for screening large population of patients.~INCLUSION CRITERIA: The Stroke Center inpatients and outpatients with known or suspected dysphagia can be included for study as well as patients who are admitted specifically for this protocol. (Difficulty swallowing food or pills,changed swallowing ability,coughing or choking when eating, shortness of breath during swallowing, food backing up into the mouth or nasal passage, fever or voice changes after swallowing, pain when swallowing, unexplained loss of weight.~EXCLUSION CRITERIA: Patients who are severely demented or severely compromised will be excluded if they do not have sufficient cognitive ability to follow directions. Non-ambulatory patients will be excluded if they cannot be braced or supported within the fluoroscopy unit. Highly agitated individuals will also be excluded if they are unable to remain confined in the equipment.~Analytic Methods The Student t test will be used to analyze the difference in epiglottis movements during swallowing amongst different phases. Levene's test for equality of variances will be applied to examine the variability of epiglottis movements during swallowing between the groups. All statistical analysis will be performed with SPSS.", - "NCTID": "NCT01249300" - }, - { - "brief_title": "Voice and Swallowing Outcomes Following Revision Anterior Cervical Spine Surgery", - "phase": "", - "drugs": "['Voice and Swallowing evaluations']", - "drugs_list": [ - "Voice and Swallowing evaluations" - ], - "diseases": "['Dysphagia', 'Dysphonia']", - "diseases_list": [ - "Dysphagia", - "Dysphonia" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients undergoing revision anterior cervical spine surgery \n\n ", - "exclusion_criteria": ": \n\n Primary pathology of the upper aero-digestive tract other than mild chronic pharyngitis, pre-existing vocal cord paralysis.", - "brief_summary": "Evaluate voice and swallowing outcomes post operatively.", - "NCTID": "NCT01017055" - }, - { - "brief_title": "A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients", - "phase": "Phase 2", - "drugs": "['Botulinum Toxin Type B (Myobloc)', 'Matched placebo to Myobloc']", - "drugs_list": [ - "Botulinum Toxin Type B (Myobloc)", - "Matched placebo to Myobloc" - ], - "diseases": "['Drooling']", - "diseases_list": [ - "Drooling" - ], - "enrollment": "54.0", - "inclusion_criteria": "inclusion criteria: \n\n Parkinsons' Disease patients with Sialorrhea for at least 3 months \n\n ", - "exclusion_criteria": ": \n\n Patients with non-idiopathic PD parkinsonism \n\n Patients previously exposed to botulinum toxins \n\n Patients with a history of aspiration pneumonia, moderate/severe choking and/or moderate/severe dysphagia \n\n Patients with prior salivary gland surgery", - "brief_summary": "To determine safety, tolerability and preliminary efficacy of intraglandular injections of MYOBLOC for the treatment of sialorrhea in Parkinsons' Disease patients", - "NCTID": "NCT00515437" - }, - { - "brief_title": "Effect of Surface Electrical Stimulation on Movement of the Larynx", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "47.0", - "inclusion_criteria": "inclusion criteria: \n\n The Healthy volunteers will be without cardiac, pulmonary, neurological, otolaryngological, psychiatric or speech, swallowing and hearing problems as determined by medical history and examination by a physician. \n\n ", - "exclusion_criteria": ": \n\n History of Rheumatic fever, mitral valve prolapse, or cardiac arrhythmias as determined by medical history, physical and EKG. A physician will auscultate for cardiac murmurs prior to any study to exclude volunteers who might be at risk for endocarditis. Subjects will have an EKG as part of the screening for participation in the study. \n\n Pregnancy will exclude women from participation because the study involves radiation exposure. \n\n None of the Healthy volunteers will have a reduction in the range of vocal fold movement during the nasoendoscopy that might suggest laryngeal paralysis or paresis, joint abnormality or neoplasm. \n\n Healthy Volunteers who have a cardiac demand pacemaker, dementia, exhibit non-stop vocalization, significant reflux due to use of a feeding tube, or drug toxicity will not be included for VitalStim, as these are contraindications to use of the device.", - "brief_summary": "This study will examine whether surface electrical stimulation on the skin of the throat will: 1) move the larynx (voice box); 2) move the vocal folds in the larynx; and 3) cause less movement of the larynx when applied during swallowing. It is important that the larynx moves up and forward while swallowing so that food does not go into the airway. A device called VitalStim\u00ae (Registered Trademark), which provides electrical stimulation to the skin on the neck and under the chin, is widely used to treat people who have problems swallowing. This study will determine if VitalStim can move the voice box or the vocal folds in the larynx. This information is important for patients who have long-term problems raising or closing their larynxes when they swallow.~Healthy volunteers between 20 and 60 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, electrocardiogram, and nasoendoscopy. For the latter procedure, the inside of the subject's nose is sprayed with a decongestant, opening the nasal passages. A small flexible tube called a nasoendoscope is passed through the nose to the back of the throat. The scope allows observation of the larynx while the subject speaks, sings, whistles and makes prolonged vowel sounds.~Participants are familiarized with the VitalStim device before beginning the experimental procedures. The device consists of two sets of electrodes and a stimulation unit. The electrodes are placed on the neck and under the chin. Stimulation causes different sensations, according to the intensity level. They include tingling/crawling, vibrating warm/burning, and grabbing. Subjects then undergo the following procedures:~Nasoendoscopy with muscle stimulation: The inside of the nose is sprayed with a decongestant and the nasoendoscope is passed through one nostril to the back of the throat. Electrodes are placed on the throat area and under the chin. Stimulation is delivered 10 times at various places on the neck and under the chin while the subject sits quietly. This test shows if the vocal folds in the voice box move with surface electrical stimulation.~Videofluoroscopy with muscle stimulation at rest and during swallowing: This is an x-ray study of the head and neck during swallowing and at rest to determine how stimulation affects the level of the voice box in the neck. Electrodes are placed under the chin and on the throat. The subject swallows 5 milliliters of barium, a contrast material that can be seen easily on x-ray. The x-ray machine is turned on for a few seconds at a time during each swallow of the barium and another 10 times while the subject is remaining still without swallowing.", - "NCTID": "NCT00104000" - }, - { - "brief_title": "Brain Mapping of Voice Control", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Voice Disorders']", - "diseases_list": [ - "Voice Disorders" - ], - "enrollment": "174.0", - "inclusion_criteria": "inclusion criteria: \n\n The inclusion criteria for normal volunteers are normal vocal function and average health as determined by the staff otolaryngologist. Normal vocal function refers to normal voice quality, a negative history for voice or laryngeal disorders. Persons with significant pulmonary, neurological and psychiatric function will not be recruited. The primary inclusion criteria for the voice disordered groups are a current diagnosis of spasmodic dysphonia (abductor or adductor type), muscular tension dysphonia or voice tremor. These persons will not have pulmonary, neurological or psychiatric disorders or ", - "exclusion_criteria": ". \n\n inclusion criteria - for Patients with Spasmodic Dysphonia: \n\n Intermittent strained hoarseness, uncontrolled voice breaks or changes in pitch are present during vowels, liquids (r & l) and semi-vowels (w & y), during speech for adductor SD or prolonged voiceless consonants producing breathy breaks for abductor SD; \n\n Less prominent symptoms during whisper, singing or falsetto, \n\n Normal voice and vocal fold movement for protective and emotional laryngeal function, such as cough, laugh or cry; \n\n A diagnosis of adductor or adductor spasmodic dysphonia based on voice testing and fiberoptic nasolaryngoscopy by a board certified otolaryngologist and Speech-Language Pathologist during the initial interview; \n\n Exclusion of other laryngeal pathologies based on a fiberoptic nasolaryngoscopic examination conducted during the initial interview by the staff otolaryngologist. \n\n inclusion criteria - for Patients with Muscular Tension Dysphonia: \n\n Increased phonatory muscle tension in the paralaryngeal and suprahyoid muscles on palpation; \n\n A consistent hypertonic laryngeal posture for phonation, such as either an anterior-posterior squeeze (pin-hole posture) or ventricular hyper adduction and an absence of SD or vocal tremor as determined by a Speech-Language Pathologist and the staff otolaryngologist; \n\n Exclusion of other laryngeal pathologies based on a fiberoptic nasolaryngoscopic examination conducted during the initial interview by the staff otolaryngologist. \n\n inclusion criteria - for Patients with Vocal Tremor: \n\n Vocal tremor during vocalization that primarily involves laryngeal structures; \n\n Exclusion of other laryngeal pathologies based on a fiberoptic nasolaryngoscopic examination conducted during the initial interview by the staff otolaryngologist. \n\n ", - "brief_summary": "Some voice disorders are caused by uncontrolled muscle actions that affect the larynx or voice box.~The purpose of this study is to understand 1) how the brain controls voice production; 2) how changes in sensation within the voice box affect brain control of the voice box; 3) how the central nervous system is affected when people have motor or sensory abnormalities that affect the voice box; and 4) whether patients with voice disorders differ from people without voice disorders in the way the brain controls the voice box. By better understanding these concepts, researchers hope to develop improved treatments for patients with voice disorders.~Forty-five healthy adult volunteers and 90 patients with voice disorders will participate in this study. Participants must be between the ages of 20 and 70. The study will involve two visits to the Clinical Center. During the first visit, participants will undergo a medical history and physical exam. During the second visit, investigators will perform the following procedures on study participants: 1) look at the voice box with a nasolaryngoscope, a fine tube through the nose; 2) use MRI [magnetic resonance imaging] to record brain activity while participants use their voice to speak; 3) changing sensation in the voice box by dripping a topical anesthetic onto the vocal folds; and 4) using MRI to again record brain activity during speech immediately after applying the topical anesthetic.~Participants will receive up to $700 in compensation for their involvement in this study.", - "NCTID": "NCT00066911" - }, - { - "brief_title": "A New Insertion Technique for Laryngeal Mask Airway", - "phase": "", - "drugs": "['Group 1 Classic', 'Group 2 pre-inflated', 'Group 3 ELL-PIC']", - "drugs_list": [ - "Group 1 Classic", - "Group 2 pre-inflated", - "Group 3 ELL-PIC" - ], - "diseases": "['Airway Morbidity']", - "diseases_list": [ - "Airway Morbidity" - ], - "enrollment": "450.0", - "inclusion_criteria": "inclusion criteria: \n\n ASA (American Society of Anesthesiologists patient fitness category) I, II, III \n\n Age 18-90 \n\n General anesthetic for where LMA (Laryngeal Mask Airway) placement is not contraindicated will be included \n\n ", - "exclusion_criteria": ": \n\n Small mouth opening \n\n Preoperative sore throat/dysphagia/dysphonia \n\n Patients at increased risk for aspiration \n\n Morbid obesity BMI > 40 \n\n Untreated chronic GERD \n\n Pregnancy \n\n Suspected supraglottic abnormalities \n\n N2O use \n\n Need for oral-pharyngeal suctioning \n\n Undergoing oral and nasal surgery \n\n Intubation or any oral instrumental manipulations other than \n\n LMA placements intraoperatively or postoperatively", - "brief_summary": "A laryngeal mask airway (LMA) is an airway device that is commonly used and placed under general anesthesia to facilitate ventilation of the patient's lungs while anesthetized. It is similar to an endotracheal tube (a breathing tube) but is less invasive. It is also placed as a backup when the Anesthesiologist is unable to pass a breathing tube and the patient is not adequately ventilating. Unfortunately, an LMA may lead to complications similar to those of breathing tube placement, such as sore throat and hoarse voice. Previous studies have examined several variables that may affect how often complications occur; these variables include giving anti-inflammatory medications and inflating the LMA to different pressures (the working end of the LMA, which rests in the patient's throat, has a cuff that is inflated to provide a seal). We are studying the effect of the PLACEMENT TECHNIQUE on postoperative sore throat, hoarse voice, and difficulty swallowing. We will be using 3 placement techniques - the traditional placement technique, a slightly different traditional placement technique, and a new technique, abbreviated the ELLIA method. The hypothesis of this study is that a new LMA insertion technique will have no difference in postoperative pharyngolaryngeal morbidity including sore throat, dysphagia and dysphonia.", - "NCTID": "NCT01749033" - }, - { - "brief_title": "Implications of Pacifier Use in Israeli Children", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Crossbite', 'Openbite', 'Drooling']", - "diseases_list": [ - "Crossbite", - "Openbite", - "Drooling" - ], - "enrollment": "400.0", - "inclusion_criteria": "inclusion criteria: \n\n healthy children aged 3-4 years that use a pacifier \n\n ", - "exclusion_criteria": ": \n\n children suffering from a chronic or developmental disease that can affect the orofacial region \n\n finger sucking children children suffering from low muscle tonus, abnormal drooling", - "brief_summary": "The purpose of this study is to examine pacifier sucking habits among children, and to assess implications of the oral habit - for example malocclusions and drooling. The effect of pacifier sucking will be recorded and compared to pacifier type and frequency of use.", - "NCTID": "NCT01249885" - }, - { - "brief_title": "Open-Label and Single-Arm Study of MYOBLOC\u00ae in the Treatment of Troublesome Sialorrhea in Adults", - "phase": "Phase 3", - "drugs": "['MYOBLOC']", - "drugs_list": [ - "MYOBLOC" - ], - "diseases": "['Sialorrhea']", - "diseases_list": [ - "Sialorrhea" - ], - "enrollment": "187.0", - "inclusion_criteria": "inclusion criteria: \n\n Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring secondary to any disorder or related to any cause, including, but not limited to, Parkinson's Disease (PD), adult cerebral palsy, amyotrophic lateral sclerosis (ALS), stroke, traumatic brain injury, oral cancer, and side effects of other medications. \n\n Able to read and provide written informed consent before enrollment into the study, or the subject's caregiver (Legally Authorized Representative) can provide written informed consent. \n\n Male or female, 18 to 85 years of age (inclusive). \n\n Minimum unstimulated salivary flow rate of 0.2 g/min at screening \n\n Minimum Investigator's Drooling Frequency and Severity Scale (DFSS) score of 4 at screening. \n\n Ability and availability to participate in the study for up to 1 year (ALS subjects: ability and availability to participate in the study for at least 6 months), based on overall health of the subject and disease prognosis \n\n ", - "exclusion_criteria": ": \n\n A moderate to high risk of aspiration will exclude participation in this study. Subjects whose risk of aspiration are judged by the Investigator to be satisfactorily controlled by placement of PEG tube or G-tube for nutritional support are eligible to participate. \n\n Respiratory forced vital capacity (FVC) of <20% of predicted \n\n Prior botulinum toxin type A or B treatment in the salivary gland(s) identified for treatment in this study within 24 weeks before screening. Prior botulinum toxin type A or B treatment into other anatomical regions not selected for treatment in this study is not exclusionary, but must have occurred at least 12 weeks before screening \n\n Subjects should be excluded if, in the Investigator's opinion, the subject failed to respond to previous treatment with botulinum toxin. Subjects should not receive nor have any plans for receiving any botulinum toxin treatment, other than the study drug (MYOBLOC), during the entire course of the study (from the point the informed consent is signed until subject's participation is complete). \n\n Concomitant use, or exposure within 5 half-lives of screening, of aminoglycoside antibiotics, curare-like agents, or other agents that interfere with neuromuscular function \n\n Prior salivary gland surgery \n\n Current treatment or treatment at any time during the study with Coumadin\u00ae (warfarin) or similar anti-coagulant medications. Anti-platelet medications are not specifically exclusionary \n\n Evidence of any clinically significant neurologic disease \n\n Pregnancy or lactation \n\n Anticipated or scheduled surgery during the study period. A PEG tube/G tube may be placed for nutritional support at any time during the study and will not exclude the subject from continued study participation. \n\n Major surgery (requiring general anesthesia, except PEG tube/G tube placement ) within the previous 6 months before screening. \n\n Current infection at the sialorrhea treatment injection site(s) \n\n History of drug or alcohol abuse currently or within the previous 6 months \n\n Participation in another clinical drug, device, or biological agent study within 30 days of screening or while participating in this study", - "brief_summary": "Multicenter, open-label, outpatient study of the safety and effectiveness of repeated doses of MYOBLOC over a 1-year duration in adult subjects with troublesome sialorrhea.", - "NCTID": "NCT02610868" - }, - { - "brief_title": "Prospective Comparison of Large vs. Small Diameter Esophageal Stents for Palliation of Malignant Dysphagia", - "phase": "Phase 1", - "drugs": "['Self-expandable metal stent']", - "drugs_list": [ - "Self-expandable metal stent" - ], - "diseases": "['Esophageal Cancer']", - "diseases_list": [ - "Esophageal Cancer" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n age \u2265 18 years \n\n dysphagia due to unresectable esophageal cancer \n\n participant resides within 50 km of Tenwek Hospital \n\n tumor is \u2264 9 cm in length and > 2 cm distal to the upper esophageal sphincter (UES) \n\n no esophago-respiratory fistula (ERF) or suspected perforation is present \n\n ", - "exclusion_criteria": ": \n\n unable to provide written informed consent", - "brief_summary": "Esophageal cancer often causes difficulty swallowing (dysphagia) that can be relieved by placement of a stent (a flexible, expandable tube that props open the blockage caused by the cancer). Stents are effective but can cause complications. Stents come in different diameters. The purpose of this study is to learn if stents of different diameters are more or less effective for treatment of dysphagia caused by esophageal cancer.", - "NCTID": "NCT01894763" - }, - { - "brief_title": "Unusual Clinical Findings of Herpes Esophagitis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Herpes Esophagitis', 'Vocal Fold Palsy']", - "diseases_list": [ - "Herpes Esophagitis", - "Vocal Fold Palsy" - ], - "enrollment": "1.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient of Herpes esophagitis with vocal palsy presentation \n\n ", - "exclusion_criteria": ": \n\n Patient of Herpes esophagitis without vocal palsy presentation", - "brief_summary": "Herpes esophagitis presents a clinical diagnostic challenge. The investigators report the first case of herpes esophagitis presenting as vocal fold palsy in an immunocompetent host. The investigators case highlights the importance of performing a detailed laryngoscopic examination in any patient with prolonged husky voice.", - "NCTID": "NCT01501526" - }, - { - "brief_title": "Improving Functional Outcomes in Patients With Unilateral Vocal Cord Paralysis: Assessment of Adaptation Using Functional Magnetic Resonance Imaging", - "phase": "", - "drugs": "['voice evaluation and fMRI', 'undergo voice evaluation and fMRI prior']", - "drugs_list": [ - "voice evaluation and fMRI", - "undergo voice evaluation and fMRI prior" - ], - "diseases": "['Intrathoracic Malignancies', 'Unilateral Vocal Cord Paralysis']", - "diseases_list": [ - "Intrathoracic Malignancies", - "Unilateral Vocal Cord Paralysis" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with UVCP undergoing type I thyroplasty or vocal fold augmentation for rehabilitation of speech and swallowing. \n\n inclusion criteria for the healthy subjects: \n\n From age 18-85 \n\n ", - "exclusion_criteria": ": \n\n for the UVCP patients includes the following: \n\n History of significant psychiatric condition (e.g. schizophrenia, obsessive-compulsive disorder, significant dementia), \n\n History of the following neurological conditions: CVA, seizure disorders, demyelinating conditions, systemic neuromuscular disorders, cerebral palsy, Alzheimer's disease. \n\n History of previous moderate to severe traumatic brain injury. \n\n History of significant cardiovascular, gastrointestinal or renal disease (e.g. myocardial infarction within the previous 12 months, significant vaso-occlusive disease, severe or advanced asthma, or renal compromise) \n\n History of achalasia \n\n History of dysphagia, odynophagia, or aphasia unrelated to present illness. \n\n History of significant claustrophobic reactions. \n\n Standard contraindications to MR examinations (e.g. implanted stimulators, pregnancy). \n\n ", - "brief_summary": "The purpose of this study is to see how the brain re-learns to control the larynx in speaking and swallowing when undergoing surgical rehabilitation in the form of either thyroplasty or vocal fold augmentation for unilateral vocal cord paralysis. What is needed is information on how the brain re-learns to control speaking and swallowing so that we can eventually learn how to help patients re-learn faster after their procedure. Functional Magnetic Resonance Imaging (or fMRI) will allow us to image your brain as you speak and swallow. We will produce brain maps for speaking, swallowing and hand movements.", - "NCTID": "NCT00597844" - }, - { - "brief_title": "Vocal Warm-up and Respiratory Muscle Training", - "phase": "", - "drugs": "['Vocal Warm-up', 'Respiratory Muscle Training']", - "drugs_list": [ - "Vocal Warm-up", - "Respiratory Muscle Training" - ], - "diseases": "['Voice Disorders']", - "diseases_list": [ - "Voice Disorders" - ], - "enrollment": "41.0", - "inclusion_criteria": "inclusion criteria: \n\n Age between 20-60. \n\n No occurence of speech therapy simultaneously to the intervention \n\n ", - "exclusion_criteria": ": \n\n Professional voice use in another activity; \n\n Frequent use of alcohol and tobacco; \n\n Influenza and/or upper respiratory tract infections (eg, rhinitis, sinusitis, pharyngitis) during the period of participation in the research.", - "brief_summary": "The purpose of this study is to verify the effects of two speech-pathology interventions: vocal warm-up and respiratory training in teachers who work in a public school of the city of Salvador-Bahia, with or without complaints of vocal disorders. It is a preventive study and the hypothesis is that both approaches can produce positive voice changes, but the Vocal Warm-up will produce the most significant changes.", - "NCTID": "NCT02102399" - }, - { - "brief_title": "Safety and Efficacy Study of Oral Glycopyrrolate Liquid for the Treatment of Pathologic (Chronic Moderate to Severe) Drooling in Pediatric Patients 3 to 18 Years of Age With Cerebral Palsy or Other Neurologic Conditions", - "phase": "Phase 3", - "drugs": "['Oral Glycopyrrolate Liquid']", - "drugs_list": [ - "Oral Glycopyrrolate Liquid" - ], - "diseases": "['Cerebral Palsy', 'Neurological Conditions', 'Mental Retardation', 'Sialorrhea']", - "diseases_list": [ - "Cerebral Palsy", - "Neurological Conditions", - "Mental Retardation", - "Sialorrhea" - ], - "enrollment": "137.0", - "inclusion_criteria": "inclusion criteria: \n\n To be included in this study, patients must meet the following criteria: \n\n Male or female, weighing at least 13 kilograms (27 pounds), aged 3 through 18 years \n\n Diagnosis of cerebral palsy and/or mental retardation or any other neurologic impairment or condition (cognitively capable and cognitively impaired patients may be enrolled) \n\n Chronic drooling in the absence of treatment to the extent that the chin or clothing becomes wet on most days by confirming the Modified Teacher's Drooling Scale score \u2265 5 \n\n Must be living in a situation where reliable parents/caregivers are willing and capable of administering medications, as determined by the investigator \n\n Written informed consent signed by the parent or legally acceptable representative \n\n Written assent signed by the age-appropriate patient if mentally capable, as determined by the investigator, and required by the site's Institutional Review Board \n\n If female of childbearing potential, the patient must have a negative pregnancy test at screening and Visit 2 \n\n If female of childbearing potential and sexually active, she must use a medically acceptable form of contraception \n\n ", - "exclusion_criteria": ": \n\n Patients are excluded from this study if they meet any of the following criteria: \n\n Patients who used glycopyrrolate within approximately 24 hours prior to the start of the baseline period, which began on Day -2 \n\n Patients who used prohibited medications within 5 plasma half-lives of the medication prior to the start of the baseline period \n\n Patients injected with intrasalivary gland botulinum toxin within 10 months prior to the start of the baseline period \n\n Patients using intraoral devices or prosthetics for the treatment of drooling within 1 week prior to the start of the baseline period \n\n Patients receiving acupuncture for the treatment of drooling or who have received acupuncture for the treatment of drooling within 3 months prior to the start of the baseline period \n\n Patients who have medical conditions contraindicating anticholinergic therapy including gastrointestinal reflux, narrow-angle glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract (i.e., delayed gastric emptying, pyloroduodenal stenosis, etc.), paralytic ileus, intestinal atony, vesicoureteral reflux, reactive airway disease, myasthenia gravis, hyperthyroidism, cardiac arrhythmias and/or tachycardia, and/or clinically significant electrocardiogram abnormalities, as determined by the investigator \n\n Patients who have a known contraindication to the study medication, including allergy to the study medication or any of its components \n\n Patients who have poorly controlled seizures defined as daily seizures \n\n Patients who have a history of obstructive disease of the gastrointestinal tract (i.e., intestinal obstruction) \n\n Patients who have clinically significant hepatic or renal impairment, at the discretion of the investigator \n\n Patients who are pregnant or breastfeeding \n\n Patients who have received any investigational drugs within 30 days of study entry \n\n Patient, families, or parents/caregivers who are expected to be non-compliant with the study procedures, as judged by the investigator \n\n Patients who are unable to meet the requirements of the study for any reason, as determined by the investigator \n\n Patients who have unstable mental disease, as determined by the investigator", - "brief_summary": "This is an open-label clinical research study of an oral glycopyrrolate liquid for the treatment of chronic moderate to severe drooling in patients with cerebral palsy or other neurological conditions. Patients participating in the study will receive oral glycopyrrolate liquid (1 mg/5 ml) three times a day (TID) for study duration of 24 weeks. After a washout, screening, and 2-day baseline period, patients will be enrolled in a 4-week dose titration period. Glycopyrrolate liquid doses will be titrated using dose levels in the Dose Titration Schedule. Titration will begin at 0.02 mg/kg per dose TID and sequentially increased in 0.02 mg/kg per dose increments TID every 5-7 days during the first four weeks until optimal individualized response is obtained for each patient or a maximum dose of 0.1 mg/kg TID is reached, not exceeding 3 mg TID or Dose-level 5 in the Dose Titration Schedule, whichever is lesser. Optimal dose for each patient is the dose at which he/she is receiving the maximum benefit from the study drug (greatest improvement in drooling) while experiencing minimum side effects. All patients will receive close attention by study staff throughout the study.", - "NCTID": "NCT00491894" - }, - { - "brief_title": "Sensory Function in Idiopathic Voice Disorders", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Phonation Disorder', 'Spastic Dysphonia', 'Voice Disorder']", - "diseases_list": [ - "Phonation Disorder", - "Spastic Dysphonia", - "Voice Disorder" - ], - "enrollment": "370.0", - "inclusion_criteria": "inclusion criteria - Normal Volunteers: \n\n Normal volunteers between the ages of 20 and 80 years of age will be selected after a screening examination. \n\n Subjects will be without cardiac, pulmonary, neurological, otolaryngological, psychiatric or speech and hearing problems as determined by medical history and examination by an otolaryngologist. \n\n None of the subjects included for study will have a reduction in the range of vocal fold movement during non-speech tasks such as whistling suggesting either paralysis or paresis, joint abnormality or neoplasm. \n\n ", - "exclusion_criteria": " - Normal Volunteers: \n\n Any patient with a history of airway obstruction will be excluded from the study. \n\n No smokers or tobacco users will be included in the study. \n\n Subjects with a history of a psychiatric disorder, under the care of a psychiatrist, or on medications for treatment of a psychiatric disorder will be excluded from study. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, currently under treatment for a major depression, or a history of schizophrenia or a bipolar disorder. However, a history of a previous episode of a minor reactive depression would not exclude a person from participation. \n\n Any individual with: 1) an implant or surgical clip - implanted neural stimulator, implanted cardiac pacemaker or autodefibrillator, cochlear implant, ocular implant, aneurysm clip, artificial heart valve, insulin pump, orthopedic pins or prosthesis: 2) a foreign body - metal shavings, shrapnel, orthodontic braces, tattoos or permanent eye liner; and/or, 3) any other implanted device or foreign body not listed above that is possibly ferromagnetic will also be excluded from study seven because of contraindications for magnetic resonance imaging. \n\n inclusion criteria - Patients with Spasmodic Dysphonia: \n\n Symptoms present during speech and not apparent at rest. \n\n Symptoms less evident during whisper, singing or falsetto. \n\n Symptoms become worse with prolonged speaking, practice or anxiety. \n\n Reflexive and emotional aspects of voice function are unaffected, such as coughing, laughter or crying. \n\n ", - "brief_summary": "This research study is designed to improve understanding about voice disorders that are due to uncontrolled muscle contractions affecting the voice box. The type of voice disorder depends on which muscles of the voice box are involved. Abductor spasmodic dysphonia may lead to a weak voice. Adductor spasmodic dysphonia may result in a strangled voice. Muscular tension dysphonia may lead to a strained voice. Some of the major goals of the study are to;~understand how sensation from the voice box affects voice and speech production~develop better ways to diagnose sensation abnormalities affecting the voice box~determine if patients with voice disorders differ from persons without voice disorders in the way they respond to sensory information from their voice box~Researchers believe that by understanding better how sensations of the voice box are presented and how the muscles in the larynx respond to those sensations they will be able to develop better treatments for patients suffering from voice disorders. ...", - "NCTID": "NCT00001922" - }, - { - "brief_title": "Role of Neurotransmission and Functional CNS Networks in Spasmodic Dysphonia", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Spasmodic Dysphonia', 'Focal Dystonia']", - "diseases_list": [ - "Spasmodic Dysphonia", - "Focal Dystonia" - ], - "enrollment": "37.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy research volunteers and adult patients with ADSD and WC will be eligible for the study. \n\n Adult patients with ADSD will have clinically documented ADSD established by voice and speech testing and fiberoptic nasolaryngoscopy. \n\n Patients will be required to have: \n\n Intermittent uncontrolled voice breaks in vowels, liquids (r & l), semivowels (w & y) during speech in ADSD (at least 3 voice breaks), or \n\n Less prominent symptoms during whisper, singing, falsetto, or shout; \n\n Normal voice and vocal fold movement during protective laryngeal functions and emotional phonation, such as cough, laughter, cry. \n\n Adult patients with WC will have clinically documented WC established by history and neurological examination. \n\n Controls will be healthy subjects with a negative history of laryngeal, neurological, or psychiatric problems. \n\n All participants will be from 21 to 80 years old and right hand dominant. \n\n All participants should be able to perform a sequential finger-tapping task for 40 seconds consecutively \n\n ", - "exclusion_criteria": ": \n\n Subjects who are incapable of giving an informed consent. \n\n Pregnant or breastfeeding women until a time when they are no longer pregnant or breastfeeding. \n\n Subjects with past or present medical history of (a) neurological problems, such as stroke, movement disorders (other than SD and WC in the patient group), brain tumors, traumatic brain injury with loss of consciousness, ataxias, myopathies, myasthenia gravis, demyelinating diseases, alcoholism, drug dependence; (b) psychiatric problems, such as schizophrenia, major and/or bipolar depression, obsessive-compulsive disorder; (c) laryngeal problems, such as vocal fold paralysis, paresis, vocal fold nodules and polyps, carcinoma, chronic laryngitis. (d) ventricular arrhythmias, renal and hepatic insufficiency, vascular headache, or carcinoid syndrome. \n\n Patients who are currently taking medications known to affect GABA and dopamine receptor binding. Occasionally, patients report receiving such medication, although dopaminergic and GABA agonist/antagonists are not typically prescribed in these patients. \n\n Patients who received treatment with botulinum toxin injections into the laryngeal muscles within the past 3 months. \n\n Patients with vocal and hand tremor or muscle tension dysphonia. \n\n Subjects who have tattoos with contraindications to MRI, ferromagnetic objects in their bodies (e.g., implanted stimulators, surgical clips, prosthesis, artificial heart valve, etc.) that cannot be removed for the purpose of study participation. \n\n Subjects who received previous radiation exposure greater than 5.0 rem per year. \n\n WC patients who experience focal hand dystonia at rest. \n\n WC patients who have focal hand dystonia associated with trauma or a known neuroanatomic lesion or disease.", - "brief_summary": "This study will examine how the brain controls speech in patients with spasmodic dysphonia, a voice disorder that involves involuntary spasms of muscles in the larynx (voice box), causing breaks in speech. Although the causes of spasmodic dysphonia are unknown, recent studies found changes in brain function in patients with the disorder that may play a role in its development.~People between 21 and 80 years of age with adductor spasmodic dysphonia may be eligible for this study. Candidates are screened with the following procedures:~Medical history and physical examination.~Nasolaryngoscopy to examine the larynx. For this test, the inside of the subject s nose is sprayed with a decongestant and a small, flexible tube called a nasolaryngoscope is passed through the nose to the back of the throat to allow examination of the larynx. The subject may be asked to talk, sing, whistle and say prolonged vowels during the procedure. The nasolaryngoscope is connected to a camera that records the movement of the vocal cords during these tasks.~Voice and speech recording to measure the type and severity of voice disorder. Subjects are asked questions about their voice disorder and their voice is recorded while they repeat sentences and sounds.~Participants undergo positron emission tomography (PET) and magnetic resonance imaging (MRI) of the brain, as follows:~PET: A catheter is placed in a vein in the subject s arm to inject a radioactive substance called a tracer that is detected by the PET scanner and provides information on brain function. [11C]flumazenil is used in one scanning session and [11C]raclopride is used in another. For the scan, the subject lies on a bed that slides in and out of the doughnut-shaped scanner, wearing a custom-molded mask to support the head and prevent it from moving during the scan. For the first scan the subject lies quietly for 60 minutes. For the second scan, the subject lies quietly for 50 minutes and is then asked to say sentences during another 50 minutes. The amount of radiation received in this study equals to a uniform whole-body exposure of 0.9 rem, which is within the dose guideline established by the NIH Radiation Safety Committee for research subjects. The guideline is an effective dose of 5 rem received per year.~MRI: This procedure uses a strong magnetic field and radio waves instead of X-rays to obtain images of the brain. The subject lies on a table that slides into the scanner, a narrow metal cylinder, wearing ear plugs to muffle loud knocking sounds that occur during the scan. Images of the brain structure are obtained while the subject lies still in the machine for 10 minutes. This is followed by functional MRI (fMRI) for 60 minutes, in which pictures are taken while the subject speaks, showing changes in brain regions that are involved in speech production.", - "NCTID": "NCT00713414" - }, - { - "brief_title": "Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet", - "phase": "", - "drugs": "['Cisatracurium', 'Normal saline']", - "drugs_list": [ - "Cisatracurium", - "Normal saline" - ], - "diseases": "['Intubation,Endotracheal']", - "diseases_list": [ - "Intubation,Endotracheal" - ], - "enrollment": "34.0", - "inclusion_criteria": "inclusion criteria: \n\n 6 months of age to 17 years of age (not yet 18) \n\n Male or female \n\n English or Spanish speaking \n\n Normal airway (Mallampati Classification ) \n\n American Society of Anesthesiology Physical Status Classification I or II \n\n Elective surgical procedure expected to last at least 45 minutes in length \n\n Written informed consent/assent for participation given by the parent legal guardian and subject (if applicable) \n\n ", - "exclusion_criteria": ": \n\n < 6 months of age, > 17 years of age \n\n Difficult airway (Mallampati Classification) \n\n History of previous difficult intubation, suspected abnormal airway: *micrognathia \n\n facial trauma \n\n airway tumor \n\n epiglottitis \n\n retropharyngeal abscess \n\n foreign body, etc. \n\n Scheduled for non-elective, emergent OR procedure \n\n Parent, legal guardian, or subject is unavailable or unwilling to consent for study participation", - "brief_summary": "The investigators' primary specific aims are to demonstrate that:~Pediatric patients with normal airways, undergoing elective surgical procedures, can be successfully intubated when deeply sedated, without the use of muscle relaxants using the Shikani Optical Stylet.~Shikani intubation of pediatric patients is equally effective in children that are deeply sedated or paralyzed as evidenced by a non-significant difference in:~Time to intubation (defined as no more than a 30 second time difference between the two groups);~Incidence of adverse events.", - "NCTID": "NCT00912990" - }, - { - "brief_title": "Treatment of Drooling With Type A Botulinum Toxin in Children With Cerebral Palsy", - "phase": "", - "drugs": "['botulinum toxin A injection']", - "drugs_list": [ - "botulinum toxin A injection" - ], - "diseases": "['Cerebral Palsy', 'Drooling']", - "diseases_list": [ - "Cerebral Palsy", - "Drooling" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n diagnosis of cerebral palsy \n\n severe drooling \n\n aged 6-21 yrs \n\n subjects (or their guardian) who are able to understand the requirements of the study and sign the informed consent form \n\n ", - "exclusion_criteria": ": \n\n age below 6 yrs or above 21 yrs \n\n known allergy or sensitivity to the study medication or its component \n\n diagnosis of myasthenia gravis, amyotrophic lateral sclerosis or any other disease that might interfere with neuromuscular function \n\n subjects who have prior surgery of the submandibular gland \n\n subjects who are receiving medication that affect drooling such as anticholinergic drug \n\n inability to give informed consent", - "brief_summary": "The purpose of this study is to evaluate the effectiveness of botulinum toxin injection to treat drooling in children with cerebral palsy, and to find the most appropriate dosage, duration of effect and side effects.", - "NCTID": "NCT00173745" - }, - { - "brief_title": "To Compare Effect of Sevoflurane Versus Desflurane on the Return of Swallowing Reflexes in the Elderly", - "phase": "Phase 4", - "drugs": "['Sevoflurane', 'Desflurane']", - "drugs_list": [ - "Sevoflurane", - "Desflurane" - ], - "diseases": "['Pulmonary Aspiration']", - "diseases_list": [ - "Pulmonary Aspiration" - ], - "enrollment": "51.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 60-85 years' old \n\n Both male and female patients \n\n ASA I-II \n\n Body mass index (BMI) \u2264 30 kg/m2 \n\n Elective surgery under general anaesthesia with the use of laryngeal mask airway (LMA) / LMA Proseal / LMA Supreme \n\n Type of surgery: Urogynecological, General Surgery, Orthopedics, Eye, Vascular, Plastic \n\n Surgery/anaesthesia lasting for 0.5-3 hours \n\n ", - "exclusion_criteria": ": \n\n Patients with difficulty in swallowing, preexisting neuromuscular or central nervous system disorder \n\n Patients undergoing intra abdominal, thoracic, face, nasal or throat surgery \n\n Known condition interfering with gastric emptying \n\n Patients with cognitive or hearing impairment and inability to provide informed consent \n\n ASA III-IV patients \n\n Use of muscle relaxant during the course of general anesthesia \n\n Contraindication or previous adverse response to any of the study drugs", - "brief_summary": "Anaesthesia and surgery has become more common in the elderly as the population survives longer. Anaesthesia in the elderly confers a higher risk which is related to the aging process and the diseases that accompany seniority. As such, there is a need to provide optimal anaesthetic management in order to minimize complications and risks perioperatively. One of the changes associated with ageing is the progressive decrease in protective laryngeal reflexes. Any depression of upper airway reflexes increases the chance of pulmonary aspiration and compromises the maintenance of the airway.~Desflurane is an inhalational agent strongly favored due to its lower solubility in blood, lean tissue and fat as compared to sevoflurane. This enables the agent to be quickly eliminated at the end of surgery, with minimal metabolic breakdown, thus facilitating more rapid emergence as compared to sevoflurane anesthesia in elderly undergoing general anaesthesia. McKay et al conducted a study in 2005 in US, which showed that the choice of inhalational agent itself can influence the return of protective airway reflexes. In the study, the inhalational agent sevoflurane was found to cause significant impairment of swallowing, in comparison with desflurane(1). However, the aforementioned study focussed on the general population. As such, the purpose of this study is to determine whether the choice of inhalational anesthetic (sevoflurane versus desflurane) has similar influence on the return of protective airway reflexes in the geriatric population in Malaysia, and whether the significance is greater in the elderly population.", - "NCTID": "NCT01833676" - }, - { - "brief_title": "Randomized Controlled Trial of Voice on Children With Vocal Nodules", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Vocal Fold Nodules']", - "diseases_list": [ - "Vocal Fold Nodules" - ], - "enrollment": "114.0", - "inclusion_criteria": "inclusion criteria \n\n Eligibility is contingent on the presence of apparent vocal fold nodules, which are defined as bilateral, localized, benign, superficial growths with protrusion on the medial surface of the true vocal folds at the junction of their anterior and middle thirds. This examination is based on video-stroboscopic examination, or, in rare cases, on operative microsuspension laryngoscopy. In addition, strict ", - "exclusion_criteria": " are applied toward excluding masses that are not nodules. Defining characteristics for these inclusion criteria are based upon the evaluations of three senior otolaryngologists of each participant's exam. Children evaluated by the senior otolaryngologist at each institution suspected to have vocal fold nodules are candidates for inclusion to this study. Patient de-identified images of the stroboscopy are reviewed by each of the other two laryngologists; only those children with confirmed vocal fold nodules by the all three senior otolaryngologists will be considered for entry into this study. \n\n Children 6 to10 years of age will be enrolled. The rationale for this age range was previously noted. In brief, children in this age range (a) have similar educational and social exposures; (b) will likely not yet encounter pubertal changes affecting the larynx; and (c) are relatively cognitively homogeneous. Moreover, children in this age range have the ability to cooperate with voice therapy and have also been shown to be tolerant of stroboscopic examination. Finally, the voice therapy regimen in this protocol has been shown to be clinically effective for many children in this age range. \n\n Voice-related quality of life must be affected to the extent that baseline PVRQOL scores are <87.5 (on a scale of the worst, 0, to the best, 100) at the time of entry into the trial. Based on previously published data, this subset of scores will be clearly distinct from scores in children with normal voices. In addition, scores <87.5 represent worse than average scores among children diagnosed with vocal fold nodules. \n\n Dysphonia duration prior to randomization must be at least 12 weeks, in order to ensure that vocal dysfunction is chronic in nature. \n\n Hearing in better ear of 35 dB or better. \n\n Agreement by informed consent from the parents and informed assent from the child participant with anticipated commitment to compliance throughout the follow up period of 3 months is necessary for enrollment which includes time commitment of up to 3 hours per week to therapy sessions and homework. \n\n Vocal fold nodules are a pathology that predominantly affects males. A number of studies and the databases utilized to track this pathology at the clinical sites indicate that the male: female ratio is approximately 7:3. Given this background, the enrollment plan for the current investigation will seek to have a 30% female representation of the patients enrolled in this study to ensure appropriate gender representation. Additionally, patients with a diagnosis of pediatric vocal fold nodules predominantly are found in Caucasian populations. However, in accordance with the National Institute of Health Revitalization Act of 1993 the inclusion of minorities in this proposal will be targeted to the representation of minorities in the greater Boston, Philadelphia and Milwaukee metropolitan regions. \n\n ", - "brief_summary": "The primary objective of this study is to determine the impact of voice therapy on voice-related quality of life in children age 6-10 years old with apparent vocal fold nodules, as measured by the validated Pediatric Voice-Related Quality of Life Instrument (PVRQOL)administered 4 weeks after completion of voice therapy.", - "NCTID": "NCT01255735" - }, - { - "brief_title": "Prospective Study of Voice Therapy in Children: A Pilot Study", - "phase": "", - "drugs": "['Adventures in Voice: Pediatric Voice Therapy']", - "drugs_list": [ - "Adventures in Voice: Pediatric Voice Therapy" - ], - "diseases": "['Vocal Fold Nodules']", - "diseases_list": [ - "Vocal Fold Nodules" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of vocal fold nodules. \n\n Age 4-11 yr. \n\n Informed Consent. \n\n English comprehension and production sufficient to participate in the protocol and in voice therapy. \n\n Considered behaviorally and cognitively appropriate by the ear, nose, and throat physician and speech-language pathologist for voice therapy. \n\n Parent and child willingness to participate in all aspects of the protocol and voice therapy. \n\n ", - "exclusion_criteria": ": \n\n Co-morbid medical conditions or medications that would mask or amplify the outcome of voice therapy, including (a) developmental or other neuromuscular conditions, (b) major illness, chronic or acute, with the exception of laryngopharyngeal reflux disease (LPR) or allergies and their treatments, which are common in both children and adults with voice disorders, thus their exclusion would severely restrict the participant pool and, moreover, threaten external validity. \n\n Hearing loss: > 20 dB hearing loss at 1000, 2000, 4000 Hz in at least one ear.", - "brief_summary": "The purpose of this prospective study is to obtain preliminary data on changes in pre-post voice therapy outcomes in children diagnosed with vocal fold nodules, as a function of a series of cognitive operations. The primary outcome is voice-related quality of life (questionnaire). Secondary outcomes are standard acoustic and aerodynamic measures derived from sustained vowel and running speech samples.", - "NCTID": "NCT02217111" - }, - { - "brief_title": "Treatment of Children With Obstructive Sleep Apnea and Laryngomalacia: the Role of Laser Supraglottoplasty", - "phase": "", - "drugs": "['supraglottoplasty with laser', 'supraglottoplasty with laser']", - "drugs_list": [ - "supraglottoplasty with laser", - "supraglottoplasty with laser" - ], - "diseases": "['Sleep Apnea, Obstructive', 'Respiration Disorders']", - "diseases_list": [ - "Sleep Apnea", - "Obstructive", - "Respiration Disorders" - ], - "enrollment": "160.0", - "inclusion_criteria": "inclusion criteria: \n\n 1 year old to 18 years of age, clinical signs or symptoms of obstructive sleep apnea (snoring, witnessed apneas, daytime somnolence, restless sleeping, or cyanosis), abnormal polysomnogram (mild, moderate, or severe OSA) including CO2 measures, failed or refused trial of CPAP, or not recommended by their pulmonologist or primary care doctor. \n\n ", - "exclusion_criteria": ": \n\n prior laser supraglottoplasty, prior adenoidectomy prior tonsillectomy, stridor with cyanosis or apnea, severe respiratory distress, recurrent pneumonia (x3), Laryngeal cyst, vocal cord (VC) Paralysis, airway vascular malformation, neoplasm, subglottic hemangioma, paradoxical vocal cord (VC) motion, posterior glottic stenosis, glottic webs, discoordinate pharyngolaryngomalacia, or refusal to participate.", - "brief_summary": "This is a research study of the effect of treating laryngomalacia (floppiness of tissue on top of the voice box that can possibly block breathing) found in association with obstructive sleep apnea (blockage of breathing while sleeping).~The purpose of this study is to determine which is the best treatment for children with obstructive sleep apnea and laryngomalacia: adenotonsillectomy alone or adenotonsillectomy with laser supraglottoplasty (removal of tissue on top of the voice box to open the airway).", - "NCTID": "NCT00394550" - }, - { - "brief_title": "Brain Activation During Simple Vocal Behaviors", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Auditory Perception']", - "diseases_list": [ - "Auditory Perception" - ], - "enrollment": "37.0", - "inclusion_criteria": "inclusion criteria: \n\n Males and females of any race or ethnicity will be eligible to participate in this study. \n\n Volunteers must be between the ages of 18 and 45 with normal hearing and voice function. Participants will be further selected for having a steady heart rate. A history of voice training is not required, but participants must be able to produce grossly independent voice F0 and amplitude changes. \n\n ", - "exclusion_criteria": ": \n\n Contraindications to participation include: pregnancy, cardiac pacemaker or auto defibrillator, artificial heart valve, neural pacemaker, surgical metal clips in the brain, eye, or on blood vessels, cochlear implants, ocular implants or foreign bodies such as metal shavings or splinters, insulin pump, implanted drug infusion device, shrapnel, bullet or shot wound, and tattooed makeup. Participants will be screened with the NMR Center Safety Screening Questionnaire which also includes items such as intraventricular shunts, transdermal medication patches, wire sutures, bone/joint pins, screws, nails, or plates, and body piercings. Given that surgical staples, orthopedic pins, orthodontic braces and dental implants are no longer considered absolute contraindications in MRI, Dr. Saxon or Dr. Kearney will approve or disapprove participation in the study based on their judgment of the MR compatibility of these items, using published guides including those referenced above. \n\n Volunteers will be also excluded if they are found to be pregnant, report any tendency toward claustrophobia or are unable for any reason to lie still within an MR scanner.", - "brief_summary": "This study will examine the central regions and brain activation patterns associated with simple vocal behaviors under conditions of normal auditory feedback-when people hear themselves speak. Such feedback plays a major role in learning and maintaining human voice control. But voice control can be harmed by neurological injury or disease, reducing the ability of a person to orally communicate. Research has shown that auditory feedback is continuously monitored, brought about by both automatic and voluntary corrections in the amplitude (loudness) and frequency of (pitch) of the human voice. This study aims to determine which areas of the brain have activity dependent on the level of blood oxygen. It will provide new knowledge about basic vocal motor control and provide a basis for investigations into the integration of hearing and speaking in human vocal expression throughout life.~Participants 18 to 45 years of age with normal hearing and voice function and with a steady heart rate may be eligible for this study.~Participants will be evaluated by a speech-language specialist, regarding a history of voice health and measures of voice function. They will be tested on their ability to vary voice amplitude and frequency and tested on their hearing. Also, they will undergo an electrocardiogram to determine their heart rate.~For the study, participants will undergo an MRI scan. During the MRI scan, patients will lie still on a table that can slide in and out of a metal cylinder surrounded by a strong magnetic field. Scanning time varies from 20 minutes to 3 hours, with most scans between 45 and 90 minutes. Patients may be asked to lie still for up to 90 minutes at a time. As the scanner takes pictures, there will be loud knocking noises, and patients will wear headphones to muffle the sound. The headphones will also enable patients to hear their voice. The patient's head will be positioned with a coil of 25 to 30 cm diameter and supported by a headrest. A microphone will be placed about 2 cm from the patient's mouth for communication and collection of data. Also, an angled mirror will be attached to the head coil, so that the patient can look outside of the scanner. By way of a projection screen, the patient will receive a visual cue to vocalize, or use his or her voice.~Patients will be asked to repeatedly do some of the following vocalization tasks: (1) rest, (2) hum or sigh without voicing (exhale), (3) hum or sigh audibly, (4) hum audibly while increasing or decreasing voice frequency, and (5) hum audibly while increasing or decreasing voice amplitude. During the scan, patients will be able to communicate with the MRI staff at all times and may ask to be moved out of the machine at any time. Some scans may be done in a 3 Tesla scanner. It is the latest advance in MRI, with a stronger magnetic field than in the more common 1.5 Tesla scanner. Functional MRI is done while a person is performing tasks, such as moving a limb or speaking. The fMRI scan will take about 1 hour.", - "NCTID": "NCT00071734" - }, - { - "brief_title": "Efficacy of Nebulized Beclomethasone Dipropionate (BDP) in the Treatment of Moderate Croup", - "phase": "Phase 3", - "drugs": "['beclomethasone dipropionate suspension for nebulisation 800 mcg/2 ml', 'Placebo solution for nebulisation 2 ml']", - "drugs_list": [ - "beclomethasone dipropionate suspension for nebulisation 800 mcg/2 ml", - "Placebo solution for nebulisation 2 ml" - ], - "diseases": "['Croup']", - "diseases_list": [ - "Croup" - ], - "enrollment": "6.0", - "inclusion_criteria": "inclusion criteria: \n\n Written informed consent obtained by parents/legal representative prior to any study-related procedures. \n\n Male or female subject aged between 6 months and 3 years referring to ER with acute onset barky cough, stridor, hoarseness, and respiratory distress \n\n Children with a diagnosis of moderate croup (Westley score 3-8) \n\n ", - "exclusion_criteria": ": \n\n Symptoms or signs of any other cause of stridor; \n\n Previous acute angioneurotic oedema; \n\n Children with diagnosis of severe croup (Wesley score >8); \n\n History of congenital or acquired stridor, diagnosis of epiglottitis, chronic pulmonary disease, asthma, severe systemic disease, exposure to chickenpox virus within the previous 21 days, or known immune dysfunction; \n\n Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study; \n\n Treatment with oral or parenteral corticosteroids within the previous 2 weeks; Treatment with epinephrine for respiratory distress before enrollment; \n\n Previous visit to an emergency room department due to croup during this episode of the disease; \n\n Inability of the parent to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments; \n\n Enrollment in another clinical trial in the previous 4 weeks or subject already admitted in this study \n\n Lack of a telephone at home;", - "brief_summary": "Acute laryngotracheobronchitis, better known as croup, is one of the common respiratory complaints among children and the most common cause of airway obstruction in children aged six months to six years. Patients with croup are typically visited by physicians during two peak time periods throughout the year. The first one is in the autumn, usually as a result of parainfluenza virus, and the second peak occurs in early winter, a consequence of RSV. Croup affects males more commonly than females and affects children between the ages of 6 months to 6 years. The incidence of croup peaks in children at 2 years of age; croup in older children is uncommon, and recurrent episodes are frequently observed.~Croup symptoms are generally short-lived, with about 60% of children showing resolution of their barky cough within 48 h. However, a few children continue to have symptoms for up to 1 week. Although most children with croup recover without specific treatment, up to 15% require hospital admission, and, among those admitted, up to 5% may require intubation.~Nebulised adrenaline is effective but it has a short duration of action and potentially dangerous side effects, and it is therefore not recommended for use in the community in mild-moderate Croup.~Oral and intramuscular steroid treatment, when given in adequate doses in hospital, has been shown to be effective for moderate to severe croup in a number of trials and a meta analysis.~It has been suggested that nebulised administration is superior to the oral or intramuscular route of administration for a more rapid onset of action and fewer side-effects.~This study is aimed to demonstrate the effectiveness of nebulised steroid administration as beclomethasone dipropionate in croup patients compare to placebo.", - "NCTID": "NCT00938353" - }, - { - "brief_title": "Oropharyngeal Space in Videolaryngoscopy", - "phase": "", - "drugs": "['C-MAC \u00ae videolaryngoscope', 'Coopdech\u00ae videolaryngoscope', 'McGrath\u00ae Series 5 videolaryngoscope', 'Glidescope\u00ae Cobalt videolaryngoscope', 'King Vision\u00ae videolaryngoscope', 'Venner\u00ae videolaryngoscope', 'McGrath\u00ae MAC']", - "drugs_list": [ - "C-MAC \u00ae videolaryngoscope", - "Coopdech\u00ae videolaryngoscope", - "McGrath\u00ae Series 5 videolaryngoscope", - "Glidescope\u00ae Cobalt videolaryngoscope", - "King Vision\u00ae videolaryngoscope", - "Venner\u00ae videolaryngoscope", - "McGrath\u00ae MAC" - ], - "diseases": "['Abrasion of Soft Palate', 'Intubation Complication']", - "diseases_list": [ - "Abrasion of Soft Palate", - "Intubation Complication" - ], - "enrollment": "489.0", - "inclusion_criteria": "inclusion criteria: \n\n Informed patient consent \n\n ASA I - III \n\n Age > 18 years \n\n Elective surgery, other than head and/or neck surgery \n\n Pre-operative Mallampati I - III \n\n BMI < 35 kg/m2 \n\n Fasted (\u22656 hours) \n\n ", - "exclusion_criteria": ": \n\n No informed patient consent \n\n ASA \u2265 IV \n\n Age < 18 year \n\n Emergency surgery, surgery of head and/of neck \n\n Locoregional anaesthesia \n\n Pre-operative Mallampati IV \n\n BMI > 35 kg/m2 \n\n Fasted < 6 hours \n\n Pre-operative expected difficult airway (restrict neck movement, thyromental distance < 65mm, retrognathia) \n\n Bad, fragile dentition \n\n Dental crowns and/or fixed partial denture", - "brief_summary": "In this randomised crossover trial we measure the space between the right side of the laryngoscope blade and the right palatopharyngeal wall in a cohort of ASA I-III patients with a normal mouth opening. We compare the remaining spaces for seven different videolaryngoscopes and compare these to a classic Macintosh laryngoscope.", - "NCTID": "NCT01609101" - }, - { - "brief_title": "TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults", - "phase": "Phase 3", - "drugs": "['Telithromycin', 'Penicillin']", - "drugs_list": [ - "Telithromycin", - "Penicillin" - ], - "diseases": "['Tonsillitis', 'Pharyngitis']", - "diseases_list": [ - "Tonsillitis", - "Pharyngitis" - ], - "enrollment": "233.0", - "inclusion_criteria": "inclusion criteria: \n\n Age equal to or over 13 years; \n\n For female subjects, the following conditions are to be met: \n\n Subject is premenarchal or surgically incapable of bearing children, \n\n Subject is of childbearing potential and all of the following conditions are met: \n\n Have normal menstrual flow within 1 month before study entry, \n\n Have negative pregnancy test (urine pregnancy test sensitive to at least 50 mU/mL, and \n\n Must agree to use an accepted method of contraception throughout the study (if sexually active); \n\n Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on: \n\n A positive result from a rapid detection test for Group A streptococcal antigen and submission of a throat swab specimen for bacterial culture, identification, and antibiotic-susceptibility testing; and \n\n A sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs: \n\n Tonsil and/or pharyngeal erythema and/or exudate; \n\n Cervical adenopathy; \n\n Uvular edema; \n\n Fever \n\n ", - "exclusion_criteria": ": \n\n Symptoms that collectively suggest nonstreptococcal T/P (eg, laryngitis, coryza, conjunctivitis, diarrhea, cough); \n\n History of positive throat culture for Streptococcus pyogenes in the absence of clinical signs and symptoms of T/P; \n\n Infection of the deep tissues of the upper respiratory tract (eg, epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (eg, sinusitis, otitis media, or orbital/periorbital cellulitis); \n\n History of rheumatic heart disease; \n\n Known congenital prolonged QT syndrome; \n\n Known or suspected uncorrected hypokalemia (\u22643 mmol/L [mEq/L) or hypomagnesemia or bradycardia (<50 bpm); \n\n Known impaired renal function, as shown by creatinine clearance \u226425 mL/min \n\n Myasthenia gravis; \n\n History of hypersensitivity or intolerance to macrolides, penicillins, or cephalosporins; \n\n Previous enrollment in this study or previous treatment with telithromycin; \n\n Children of the investigator or subinvestigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the protocol. \n\n Is currently being treated with systemic antibacterials or has been treated with systemic antibacterials within 14 days prior to enrollment; \n\n Has been treated with any investigational medication within the last 30 days; \n\n Has been treated with rifampicin, phenytoin, carbamazepine, or St. John's wort within the last 2 weeks.", - "brief_summary": "This is a multinational, randomized (1:1), double blind, comparator-controlled, 2 parallel treatment group study in subjects equal to or over 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P). Each subject will receive either telithromycin, 400 mg over-encapsulated tablets, 800 mg once daily for 5 days or penicillin V 250 mg over-encapsulated tablets, 500 mg three times daily for 10days. Matching placebo capsules will be dispensed to maintain the blind between the treatment groups.A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.", - "NCTID": "NCT00315549" - }, - { - "brief_title": "Randomized Controlled Trial (RCT) in Children With Severe Pneumonia", - "phase": "", - "drugs": "['Day-care treatment vs. hospital care']", - "drugs_list": [ - "Day-care treatment vs. hospital care" - ], - "diseases": "['Severe Pneumonia']", - "diseases_list": [ - "Severe Pneumonia" - ], - "enrollment": "368.0", - "inclusion_criteria": "inclusion criteria: \n\n Age: 2 to 59 months \n\n Sex: Both boys and girls \n\n Severe pneumonia according to WHO criteria (Severe pneumonia is defined as cough or difficult breathing with lower chest wall in drawing with or without fast breathing which is defined as the respiratory rate \u2265 50 breaths per minute for children aged 2-11 months and \u2265 40 breaths per minute for children aged 12-59 months) \n\n Attend the Radda Clinic and ICHSH between 8:00 am to 4:00 pm (Sunday through Saturday) \n\n Written informed consent by respective parents/guardians \n\n ", - "exclusion_criteria": ": \n\n Very severe and non-severe pneumonia \n\n Nosocomial pneumonia \n\n History of taking antibiotics for pneumonia within 48 hour prior to enrollment \n\n Chronic illnesses like tuberculosis, cystic fibrosis \n\n Congenital deformities/anomalies e.g. Down's Syndrome, congenital heart disease \n\n Immunodeficiency \n\n Trauma/burn \n\n Bronchiolitis \n\n Bronchial asthma \n\n Lives far away from the Radda Clinic and ICHSH (outside 5 km radius from the respective study site) \n\n Parents/guardians not consenting for inclusion of their children in the study", - "brief_summary": "Pneumonia is the leading cause of childhood morbidity and death in many developing countries including Bangladesh, causing about 2 million deaths worldwide each year. Pneumonia is an infection of the lungs, most commonly caused by viruses or bacteria like Streptococcus pneumoniae and Haemophilus influenzae. Depending on the clinical presentation, pneumonia can be classified as very severe, severe or non-severe, with specific treatment for each of them except for antibiotic therapy. Severe and very severe pneumonia require hospitalization for additional supportive treatment such as suction, oxygen therapy and administration of bronchodilator. In Bangladesh, the number of hospital beds is inadequate for admission of all pneumonia cases that require hospitalization; however, it is also important to provide institutional care to those children who cannot be hospitalized due to bed constraints. Provision of appropriate antibiotics and supportive cares during the period of stay at established day-care centres could be an effective alternative. The impetus for this study came from the findings of our recently completed study titled Daycare-based management of severe pneumonia in under-5 children when hospitalization is not possible due to the lack of beds. This study successfully managed children (n=251), but it was not a randomized trial and thus direct comparison of the efficacy of management of severe pneumonia at the day-care centre, essential for building confidence for implementing this management policy, is not possible. We, the researchers at the International Centre for Diarrhoeal Disease Research, Bangladesh, could not plan a randomized, controlled trial (RCT) because of ethical reasons. Now that we have data suggesting effectiveness as well as safety of the day-care based treatment for management of children with severe pneumonia, a RCT should be possible. Two hundred fifty-one children with severe pneumonia were enrolled at the Radda Clinic from June 2003 to May 2005. The mean age was 7\u00b17 (2-55) months, 86% infants, 63% boys and 91% breast-fed. History of cough was present in 99% cases, fever in 89% and rapid breathing in 67% cases. Forty-four percent of children were febrile (\u226538\u00b0C), 93% children had vesicular breath sound and 99% bilateral rales. Fifty-seven percent of children were hypoxic with mean oxygen saturation of (93\u00b14)%, which was corrected by oxygen therapy (98\u00b13)%. Eighty percent of children had severe pneumonia and 20% had very severe pneumonia. The mean duration of clinic stay was (7\u00b12) days. Two hundred thirty-four (93%) children completed the study successfully, 11 (4.4%) referred to hospitals (only one participant had to visit hospital at night due to deterioration of his condition, 9 were referred to hospital at the time of clinic closure i.e., at 5 pm and one participant was referred to hospital during the morning hours) and 6 (2.4%) left against medical advice (LAMA). There was no death during the period of clinic stay but only four (1.6%) deaths occurred during the 3 months follow-up. The study indicated that treatment of severe pneumonia in children at the day-care centre is effective and safe and thus it is comparable to the hospital care. If the day-care based management is found to have comparable efficacy to that of hospitalized management of severe pneumonia in children then they could be managed at outpatient, day-care set ups reducing hospitalization and thus freeing beds for management of other children who need hospitalized care. Additionally, availability of the treatment facility in community set-ups will be cost and time saving for the population. Children of either sex, aged 2-59 months, attending the Radda Clinic and Institute of Child Health and Shishu Hospital (ICHSH) with severe pneumonia will be randomized to receive either the day-care management at the clinic or hospitalized management at the ICHSH. Children randomized to receive day-care treatment will stay at the clinic from 8 am-5 pm and will receive antibiotics and other supportive cares. At 5 pm, they would be send to respective homes with advice to bring back their children to the clinic next morning, and advised to provide other supports at home. The same management would be continued till improvement and discharged and followed up every 2 weeks for 3 months. Children randomized to receive hospitalized management would be admitted at ICHSH and receive standard treatment like antibiotics and other supportive cares. The same treatment would be continued for 24 hours/day (rather than 9 hours/day at the day-care clinic) till improvement and discharged and followed-up at the ICHSH every 2 weeks for 3 months. About 3000 children with pneumonia visit Radda Clinic each year and about 200 of them will have severe pneumonia requiring hospitalization. Thus, we hope to enroll 368 (184 in each site) children with severe pneumonia during a 2-year study period.", - "NCTID": "NCT00455468" - }, - { - "brief_title": "A Study to Identify and Characterise Bacteria Causing Chronic Cough Among Children in United Kingdom", - "phase": "", - "drugs": "['Cough swab', 'Oropharyngeal swab', 'Nasopharyngeal swabs', 'Blood sample', 'Bronchoscopy/ bronchoalveolar lavage samples', 'Data collection']", - "drugs_list": [ - "Cough swab", - "Oropharyngeal swab", - "Nasopharyngeal swabs", - "Blood sample", - "Bronchoscopy/ bronchoalveolar lavage samples", - "Data collection" - ], - "diseases": "['Infections, Respiratory Tract']", - "diseases_list": [ - "Infections", - "Respiratory Tract" - ], - "enrollment": "19.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects who the investigator believes that parent(s)/ legally acceptable representative can and will comply with the requirements of the protocol. \n\n A male or female child between, and including, six to 72 months of age at the time of enrolment. \n\n Written informed consent obtained from the parent(s)/ legally acceptable representative of the subject. \n\n No antibiotic therapy within four weeks prior to the visit. \n\n No cystic fibrosis or known major immunodeficiency such as agammaglobulinaemia, T cell deficiency or Human Immunodeficiency Virus / Acquired Immune Deficiency Syndrome. \n\n No documented evidence or suspicion of gastroesophageal reflux disease. \n\n No evidence of an upper viral respiratory infection four weeks prior to the visit. \n\n In addition, all subjects regarded as 'cases' must satisfy all the following criteria at study entry: \n\n Persistent cough greater than eight weeks. \n\n No response to five-day prednisolone treatment. \n\n Chest X-ray showing no evidence of a lobar pneumonia or gross structural abnormality. \n\n In addition, all subjects regarded as 'controls' must satisfy the following criteria at study entry: \n\n No respiratory symptoms four weeks prior to the visit. \n\n No documented evidence or suspicion of lung disease upon physical examination. \n\n ", - "exclusion_criteria": ": \n\n Concurrently participating in another study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. \n\n Use of any investigational or non-registered product within 30 days prior to study procedures, or planned use during the study period. \n\n Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. \n\n Child in care.", - "brief_summary": "The purpose of this study is to investigate the role of Haemophilus influenzae and other bacteria in causing chronic cough, through a direct comparison of chronic cough cases and healthy controls recruited from paediatric respiratory clinics in the United Kingdom.", - "NCTID": "NCT01292213" - }, - { - "brief_title": "Effect of Desipramine on Upper Airway Collapsibility and Genioglossus Muscle Activity in Patients With Obstructive Sleep Apnea - Study B", - "phase": "Phase 2", - "drugs": "['Desipramine', 'Placebo']", - "drugs_list": [ - "Desipramine", - "Placebo" - ], - "diseases": "['Sleep Apnea, Obstructive']", - "diseases_list": [ - "Sleep Apnea", - "Obstructive" - ], - "enrollment": "16.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosed OSA (moderate-to-severe; apnea hypopnea index >15 events/hr) \n\n ", - "exclusion_criteria": ": \n\n Cardiovascular disease other than well controlled hypertension \n\n Depression", - "brief_summary": "Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal participants. Until recently, the search for medicines to activate pharyngeal muscles in sleeping humans has been discouraging. However, exciting new animal research has shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle activity to waking levels. In this protocol the investigators will test the effect of desipramine (a tricyclic antidepressant with strong noradrenergic and antimuscarinic effects) on upper airway collapsibility and genioglossus muscle activity (EMG GG) during sleep in OSA patients.", - "NCTID": "NCT02436031" - }, - { - "brief_title": "Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Children", - "phase": "Phase 1", - "drugs": "['0.5ml/dose for a person', '0.5ml/dose for a person']", - "drugs_list": [ - "0.5ml/dose for a person", - "0.5ml/dose for a person" - ], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy subjects aged from 6 months to 5years old of normal intelligence \n\n The subjects'guardians are able to understand and sign the informed consent \n\n Subjects established as healthy after medical history questioning,physical examination and clinical decision and in accordance with vaccination requirements of the experimental vaccine \n\n Subjects who can comply with the requirements of the clinical trial program according to the researcher's views \n\n Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine \n\n Subjects with temperature <37\u00b0C on axillary setting \n\n ", - "exclusion_criteria": ": \n\n ", - "brief_summary": "Haemophilus influenzae is an important pathogen which can cause primary infection and respiratory viral infection in infants and leaded to secondary infections. The infection of haemophilus is a major cause of morbidity and mortality in infants and children. At present, the developed conjugant Hib vaccine is proved to be safe and effective, 90-99% of children will produce antibody of protection after 3 doses. Because Hib vaccine can prevent meningitis, pneumonia, epiglottis inflammation and other serious infection caused by Hib bacteria, the WHO suggested that Hib vaccine should be included in the infant's normal immune programming.~Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus polysaccharide vaccine with a relatively poor immune response in the infants under the age of two, and the remaining 60% with a low antibody level and a short duration.~According to the present immunization schedule, to reach the median level of antibody levels there are at least 4 doses in need. So it is meaningful to improving vaccine immunogenicity, to provide high levels of long-term protection and to reduce the number of injections.~The objective of this study is to evaluate the safety of the group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine.", - "NCTID": "NCT01406509" - }, - { - "brief_title": "Stimulus-Stimulus Pairing Study", - "phase": "", - "drugs": "['Stimulus-stimulus pairing', 'Vocal recorder']", - "drugs_list": [ - "Stimulus-stimulus pairing", - "Vocal recorder" - ], - "diseases": "['Autism Spectrum Disorder']", - "diseases_list": [ - "Autism Spectrum Disorder" - ], - "enrollment": "16.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of autism \n\n Currently do not emit vocalizations or minimally verbal \n\n Willingness of the participant's parent/guardian to bring their child to the Marcus Autism Center for one-hour appointments, five days a week, for six weeks. \n\n ", - "exclusion_criteria": ": \n\n 1. Children with significant problem behavior that interferes with structured intervention", - "brief_summary": "The purpose of the current study is to deliver the SSP procedure to children diagnosed with autism that do not have vocal language. The study will also aim to gather data in the natural environment using a voice recorder.", - "NCTID": "NCT02464527" - }, - { - "brief_title": "Postoperative Distress and Cosmetic Outcomes After Open Versus Robotic Thyroidectomy", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Thyroidectomy', 'Distress', 'Surgery']", - "diseases_list": [ - "Thyroidectomy", - "Distress", - "Surgery" - ], - "enrollment": "84.0", - "inclusion_criteria": "inclusion criteria: \n\n (a) a minimally invasive follicular thyroid carcinoma \u22644 cm in diameter, or \n\n (b) a papillary thyroid carcinoma \u22642 cm in diameter. \n\n ", - "exclusion_criteria": ": \n\n (a) previous neck operations; \n\n (b) age <21 or >65 years; \n\n (c) prior vocal fold paralysis or a history of voice or laryngeal disease requiring therapy; \n\n (d) a malignancy with definite extrathyroid invasion, multiple lateral neck node metastasis, perinodal infiltration at a metastatic lymph node, or distant metastasis; and/or \n\n (e) a lesion located in the thyroid dorsal area (especially adjacent to the tracheoesophageal groove) caused by possible injury to the trachea, esophagus, or recurrent laryngeal nerve (RLN)", - "brief_summary": "Robotic assistance during thyroid surgery has been utilized clinically in Korea since late 2007. Robotic thyroidectomy has also been validated for surgical management of the thyroid gland. Compared with endoscopic thyroidectomy, the use of a robot in an endoscopic approach via the axilla provides a broader view of the thyroid bed, albeit from a lateral, as opposed to the conventional anterior, perspective. The wrist action of a surgical robot also provides a greater degree of movement than afforded by the use of simple endoscopic instruments, and tremor is eliminated.~Although several reports on operative outcomes of the robotic technique have appeared, no prospective trials comparing the clinical results of robotic with conventional open thyroidectomy have been described. We therefore designed a prospective trial comparing outcomes, including postoperative distress and patient satisfaction, between patients undergoing robotic and conventional open thyroidectomy.", - "NCTID": "NCT01075269" - }, - { - "brief_title": "Immunogenicity and Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Infants and Children", - "phase": "Phase 3", - "drugs": "['A+C+hib Conjugate Vaccine', 'Placebo', 'A+C Vaccine', 'Hib vaccine']", - "drugs_list": [ - "A+C+hib Conjugate Vaccine", - "Placebo", - "A+C Vaccine", - "Hib vaccine" - ], - "diseases": "['Group A, C Polysaccharide Meningitis', 'Type b Haemophilus Influenza']", - "diseases_list": [ - "Group A", - "C Polysaccharide Meningitis", - "Type b Haemophilus Influenza" - ], - "enrollment": "2394.0", - "inclusion_criteria": "For the children (aged from 2 to 5 years old) \n\n inclusion criteria: \n\n Healthy subjects aged from 2 to 5 years old of normal intelligence. \n\n The subjects' guardians are able to understand and sign the informed consent. \n\n Subjects established as healthy after medical history questioning, physical examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine. \n\n Subjects who can comply with the requirements of the clinical trial program according to the researcher's views. \n\n Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine. \n\n Subjects with temperature <37\u00b0C on axillary setting. \n\n ", - "exclusion_criteria": ": \n\n Subject who has a medical history of Meningitis; \n\n Subject that has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on; \n\n Subject who is allergic with tetanus toxoid components; \n\n Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection; \n\n Subject who has a history of allergic reactions; \n\n Any known immunological dysfunction; \n\n Had received gamma globulin or immune globulin, in the past two weeks \n\n Subject suffering from congenital malformations, dysgenopathy or serious chronic disease; \n\n Any acute infections \n\n Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives \n\n For the infants (aged from 6 to 23 months old) \n\n inclusion criteria: \n\n Healthy subjects aged from 6 months to 23 months old of normal intelligence. \n\n The subjects' guardians are able to understand and sign the informed consent. \n\n Subjects established as healthy after medical history questioning, physical examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine. \n\n Subjects who can comply with the requirements of the clinical trial program according to the researcher's views. \n\n Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine. \n\n Subjects with temperature<37\u00b0C on axillary setting. \n\n ", - "brief_summary": "Haemophilus influenzae is an important pathogen which can cause primary infection and respiratory viral infection in infants and leaded to secondary infections. The infection of haemophilus is a major cause of morbidity and mortality in infants and children. At present, the developed conjugant Hib vaccine is proved to be safe and effective. Because Hib vaccine can prevent meningitis, pneumonia, epiglottis inflammation and other serious infection caused by Hib bacteria, the WHO suggested that Hib vaccine should be included in the infant's normal immune programming.~Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus polysaccharide vaccine with a relatively poor immune response in the infants under the age of two, and the remaining 60% with a low antibody level and a short duration.~According to the present immunization schedule, to reach the median level of antibody levels there are at least 4 doses in need. So it is meaningful to improving vaccine immunogenicity, to provide high levels of long-term protection and to reduce the number of injections.~After the phase I study which was conducted in August, 2011, the safety profile of this vaccine is proved to be acceptable. The phase III study is aimed to further evaluate the safety and the immunization of the vaccine. The objective of this study is to evaluate the safety of the group A, C polysaccharide meningococcal and type b haemophilus influenzal conjugate vaccine.", - "NCTID": "NCT01428908" - }, - { - "brief_title": "A Post Marking Study to Evaluate the Safety of FluMist in Children", - "phase": "", - "drugs": "['FLuMist', 'TIV (Injection)', 'Unvaccinated Control']", - "drugs_list": [ - "FLuMist", - "TIV (Injection)", - "Unvaccinated Control" - ], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "29296.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy \n\n Age: born within the same calendar quarter as the reference FluMist vaccinee. \n\n ", - "exclusion_criteria": ": \n\n Children who have evidence of medical conditions that put them at high risk for complications of influenza (e.g., chronic cardiovascular and pulmonary disease) will be excluded from this control group.", - "brief_summary": "To assess the safety of FluMist vaccination", - "NCTID": "NCT00569894" - }, - { - "brief_title": "Phase 3 Study of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine", - "phase": "Phase 3", - "drugs": "['A+C+hib Conjugate Vaccine', 'Placebo', 'A+C Vaccine', 'Hib vaccine']", - "drugs_list": [ - "A+C+hib Conjugate Vaccine", - "Placebo", - "A+C Vaccine", - "Hib vaccine" - ], - "diseases": "['Meningitis', 'Influenza']", - "diseases_list": [ - "Meningitis", - "Influenza" - ], - "enrollment": "900.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy subjects aged 3 to 5 months, normal intelligence. \n\n The subjects' guardians are able to understand and sign the informed consent. \n\n Healthy subjects confirmed by medical history questioning, physical examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine. \n\n Subjects who can comply with the requirements of the clinical trial program according to the researcher's views. \n\n Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine. \n\n Subjects with temperature<=37\u00b0C on axillary setting. \n\n ", - "exclusion_criteria": " for the first vaccination: \n\n Subject who has a medical history of Meningitis; \n\n Subject who has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on; \n\n Subject who is allergic with tetanus toxoid components; \n\n Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection; \n\n Subject who has a history of allergic reactions; \n\n Any known immunological dysfunction; \n\n Had received gamma globulin or immune globulin, in the past two weeks \n\n Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws \n\n Any acute infections in last 7 days \n\n Any prior administration of immunodepressant or corticosteroids in last 6month \n\n Any prior administration of other research medicines in last 1 month \n\n Any prior administration of attenuated live vaccine in last 28 days \n\n Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine \n\n Subject suffering from congenital malformations, developmental delay or serious chronic disease; \n\n Any acute infections \n\n Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives \n\n ", - "brief_summary": "Haemophilus influenzae is an important pathogen which can cause primary infection and respiratory viral infection in infants and leaded to secondary infections. The infection of haemophilus is a major cause of morbidity and mortality in infants and children. At present, the developed conjugant Hib vaccine is proved to be safe and effective. Because Hib vaccine can prevent meningitis, pneumonia, epiglottis inflammation and other serious infection caused by Hib bacteria, the WHO suggested that Hib vaccine should be included in the infant's normal immune programming.~Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus polysaccharide vaccine with a relatively poor immune response in the infants under the age of two, and the remaining 60% with a low antibody level and a short duration.~The immunogenicity and safety of this vaccine has been proved in older children aged 6-23 months and 2-5 years. And in the phase I study which was conducted in February, 2012, the safety profile of this vaccine is proved to be acceptable in infants aged 3-5 months. The phase III study is aimed to further evaluate the safety and the immunization of the vaccine. The objective of this study is to evaluate the safety of the group A, C polysaccharide meningococcal and type b haemophilus influenzal conjugate vaccine.", - "NCTID": "NCT01580033" - }, - { - "brief_title": "Assessing the Necessity of Prescribing Antibiotics (Clavulin or Clindamycin Versus Placebo) Post-peritonsillar Abscess Drainage", - "phase": "", - "drugs": "['Clavulin', 'Randomization to Placebo', 'Clindamycin']", - "drugs_list": [ - "Clavulin", - "Randomization to Placebo", - "Clindamycin" - ], - "diseases": "['Peritonsillar Abscess']", - "diseases_list": [ - "Peritonsillar Abscess" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Older than 18 years of age \n\n Diagnosed with a peritonsillar abscess that has been drained and purulence has been obtained \n\n ", - "exclusion_criteria": ": \n\n Pregnant \n\n Under the age of 18 \n\n Bilateral peritonsillar abscesses \n\n Recently drained peritonsillar abscess \n\n Immunocomprimised", - "brief_summary": "This study aims to look at the necessity for prescribing antibiotics post-drainage of peritonsillar abscesses (PTA). This will be a single-blinded randomized-control trial with two arms - patients receiving placebo versus those receiving a seven day course of oral Amoxicillin-Clavulanic acid. The main objective measure will be to assess if there is resolution of the peri-tonsillar abscess and there has been no reaccumulation. Patients will be blinded to whether they receive placebo or amoxicillin-clavulanic acid. Patients will be phoned after 7 days to assess if their symptoms have resolved via an over the phone questionnaire. Anaerobic and aerobic cultures will be obtained.", - "NCTID": "NCT01715610" - }, - { - "brief_title": "The Effect of Peritonsillar Infiltration of Ketamine and Dexamethasone for Postoperative Pain Relief in Children Following Adenotonsillectomy", - "phase": "Phase 1; Phase 2", - "drugs": "['saline', 'Ketamine', 'Dexamethasone', 'ketamine-dexamethasone']", - "drugs_list": [ - "saline", - "Ketamine", - "Dexamethasone", - "ketamine-dexamethasone" - ], - "diseases": "['Tonsillectomy']", - "diseases_list": [ - "Tonsillectomy" - ], - "enrollment": "160.0", - "inclusion_criteria": "inclusion criteria: \n\n children age 3-12 years ASAI,II \n\n ", - "exclusion_criteria": ": \n\n contraindication for usage of Ketamine, dexamethasone \n\n upper respiratory tract infection \n\n increase intracranial pressure( ICP) \n\n history of allergy ,seizure,psychiatric illness, , bleeding disorders \n\n chronic usage of analgesic ,antiemetic ,stroied drugs two weeks before surgery, \n\n history of peritonsillar abscess, , tonsillitis within two weeks, -", - "brief_summary": "The immediate postoperative period after tonsillectomy, , is often difficult. These children frequently have severe pain but postoperative airway edema along with increased sensitivity to the respiratory-depressant effects of opioids may result in obstructive symptoms and hypoxemia. Opioid consumption may be reduced by non-steroidal anti-inflammatory drugs, but these drugs may be associated with increased bleeding after this operation.~Methods: One hundred sixty ASA I-II children 3-12 were randomized four groups of 40 each. Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg dexamethasone 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per tonsil 3 min prior to tonsillectomy. Study drugs were marked only with a coded number label. A computer-generated table of numbers guided randomization. Modified Hannallah pain scale [observational pain scores (OPS)], nausea, vomiting, bleeding, rescue analgesia, sedation and Aldrete scores were recorded at first, 15th, 30th and 60th min postoperatively. Patients were interviewed on the day after surgery to assess the postoperative pain, nightmares, hallucinations, vomiting and bleeding. All the children were premedicated with midazolam hydrochloride 0.3 mg/kg) and fentanyl 1micro g/kg intavenously. Anesthesia was induced with thiopental 5mg/kg and atracurium0.3mg/kg. Anesthesia was maintained with isoflurane 1.5% and nitrous oxide 30% in oxygen. The two surgeon used the same dissection and snare technique for all cases and hemostasis done with bipolar cutter. At the end of the surgery neuromuscular blockade was reversed by neostigmine 0.03 mg/kg) and atropine 0.01 mg/kg intravenously), anesthesia was discontinued and the tracheal tube removed in the operating room when patients were deep. After extubation the patients were taken to the postanesthesia care unit (PACU) where an nurse who were unaware of the study drug observed the patients. The pain scoring observer nurse in PACU was consistent. Time to awaken (from the end of anesthesia until the patients opened their eyes on command) and time to the first administration of postoperative analgesia were recorded. Pethidine in a titrated dose (total 1 mg/kg) was administered intravenously for rapid pain relief to patients with a OPS score > 4 or who were crying during two consecutive five minute observation periods until the child was comfortable. Postoperative pain during the first 24 h was assessed using a four-point scale: 0 no pain, 1 mild pain, 2 moderate pain, 3 severe pain by questioning their parents. In the ward the standardized postoperative analgesic technique was with acetaminophen supp (40 mg/kg followed by three doses of 20 mg/kg at 6-hour intervals to be given as needed for pain. Pethidine in a titrated dose (total 1 mg/kg) was administered intravenously for rapid pain relief to patients who had pain scale >3.Any supplementary analgesia , nausea and vomiting, bleeding, sleep disturbance and nightmares that the child might have had as surgery were assessed during a telephone follow up 24 h later.", - "NCTID": "NCT01198210" - }, - { - "brief_title": "Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Nasopharyngeal Carriage of Streptococcus Pneumoniae']", - "diseases_list": [ - "Nasopharyngeal Carriage of Streptococcus Pneumoniae" - ], - "enrollment": "3900.0", - "inclusion_criteria": "inclusion criteria for FinIP-vaccinated children: \n\n age 3 to 5 years \n\n enrolled in the FinIP trial and has received at least one dose of study vaccine in the infant vaccine schedule (3+1 or 2+1) \n\n at least one parent with fluent Finnish \n\n informed consent from one parent \n\n ", - "exclusion_criteria": " for FinIP-vaccinated children \n\n PCV vaccination administered, other than the randomized study vaccine \n\n history of antimicrobial treatment within 4 weeks (the child can be enrolled later) \n\n inclusion criteria for unvaccinated siblings \n\n age 5 to 9 years \n\n younger sibling living in the same household having participated in the FinIP trial (regardless of the vaccination schedule) \n\n at least one parent with fluent Finnish \n\n informed consent from one parent \n\n ", - "brief_summary": "The purpose of this study is to assess the direct effects of the ten-valent pneumococcal conjugate vaccine administered to infants on nasopharyngeal carriage at 3 to 5 years of age.~These children have been vaccinated in infancy in the cluster-randomized Finnish Invasive pneumococcal Disease (FinIP) Trial (a separate protocol reported at ClinicalTrials.gov Identifier:NCT00861380) during 2009 to 2011.~Also the indirect effect on nasopharyngeal carriage will be assessed on vaccinees' elder non-vaccinated siblings aged 5 to 9 years.", - "NCTID": "NCT01925222" - }, - { - "brief_title": "Efficacy of Peritonsillar Dexmedetomidine Infiltration for Postadenotonsillectomy Pain", - "phase": "Phase 4", - "drugs": "['Dexmedetomidine']", - "drugs_list": [ - "Dexmedetomidine" - ], - "diseases": "['Pain Postoperative, Intraoperative Hemorrhage']", - "diseases_list": [ - "Pain Postoperative", - "Intraoperative Hemorrhage" - ], - "enrollment": "71.0", - "inclusion_criteria": "inclusion criteria: \n\n children aged 3-9 years American Society of Anesthesiologists 1-2 status, scheduled for adenotonsillectomy \n\n ", - "exclusion_criteria": ": \n\n Children with systemic disease, metabolic and endocrin disorders, growth developmental and motor-mental retardation, those who had a history of allergy to any of the study drugs, peritonsillar abscess, hypertension, psychiatric and epileptic disorders, chronic pain syndrome, and those who received analgesics within 24 h prior to surgery were excluded from study.", - "brief_summary": "The purpose of the present study is the clinical assessment of the efficacy of preincisional peritonsillar infiltration of dexmedetomidine on postoperative pain relief in children undergoing adenotonsillectomy.", - "NCTID": "NCT02013570" - }, - { - "brief_title": "The Impact of Arousal Threshold in Obstructive Sleep Apnea", - "phase": "Phase 4", - "drugs": "['Donepezil', 'placebo']", - "drugs_list": [ - "Donepezil", - "placebo" - ], - "diseases": "['Obstructive Sleep Apnea']", - "diseases_list": [ - "Obstructive Sleep Apnea" - ], - "enrollment": "44.0", - "inclusion_criteria": "inclusion criteria: \n\n Ages 18-70 years \n\n sleep study (with apnea hypopnea index>5) \n\n Diagnosis of obstructive sleep apnea \n\n ", - "exclusion_criteria": ": \n\n Any known unstable cardiac (apart from treated hypertension), pulmonary (including asthma), renal, neurologic (including epilepsy), neuromuscular, or hepatic disease. \n\n Susceptible to stomach ulcers. \n\n Pregnant women or Nursing mothers \n\n Using positive airway pressure (PAP) therapy over one week or longer \n\n Body weight <55kg \n\n History of hypersensitivity to Afrin, Lidocaine and/or Donepezil \n\n History of bleeding diathesis and/or gastrointestinal bleeding. \n\n Use of any medications that may affect sleep or breathing. \n\n A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders. \n\n Substantial cigarette (>5/day), alcohol (>3oz/day) or use of illicit drugs. \n\n More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day. \n\n Deprived from sleep in the recent one week \n\n Desaturations to below 70% lasting greater than 10 seconds in duration per event in the sleep study (without Oxygen).", - "brief_summary": "The investigators hypothesis is that obstructive sleep apnea (OSA) patients with a low arousal threshold may wake up too early during a respiratory event, before upper airway muscles can be activated to achieve stable ventilation. Thus, strategies to manipulate the respiratory arousal threshold could potentially improve the quality of sleep and sleep disordered breathing. Agents that raise arousal threshold are therefore likely to benefit some patients with OSA. The overall goal of this project is to determine the importance of the arousal threshold in OSA, determine which patients might benefit from a raised arousal threshold, and test this hypothesis by using pharmacological manipulation of the arousal threshold to achieve this goal.", - "NCTID": "NCT02264353" - }, - { - "brief_title": "The Effects of Trazodone on Sleep Apnea Severity", - "phase": "", - "drugs": "['Placebo pill', 'Trazodone']", - "drugs_list": [ - "Placebo pill", - "Trazodone" - ], - "diseases": "['Sleep Apnea, Obstructive']", - "diseases_list": [ - "Sleep Apnea", - "Obstructive" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria for OSA Patients: \n\n OSA (elevated AHI). \n\n Age range 18-70 years. \n\n ", - "exclusion_criteria": ": \n\n Any known cardiac (apart from treated hypertension), pulmonary (including asthma), renal, neurologic (including epilepsy), neuromuscular, or hepatic disease. \n\n Susceptible to stomach ulcers. \n\n Pregnant women. \n\n History of hypersensitivity to Afrin, Lidocaine, trazodone and/or donepezil. \n\n History of bleeding diathesis and/or gastrointestinal bleeding. \n\n Use of any medications that may affect sleep or breathing. \n\n A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders. \n\n Substantial cigarette (>5/day), alcohol (>3oz/day) or use of illicit drugs. \n\n More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day. \n\n Desaturations to below 70% lasting greater than 10 seconds in duration per event on polysomnography.", - "brief_summary": "In Obstructive sleep apnea (OSA), the upper airway closes over and over again during sleep. This leads to disrupted sleep (waking up during the night), daytime sleepiness, and an increased risk for developing high blood pressure. Currently, the best treatment for obstructive sleep apnea is sleeping with a mask that continuously blows air into the nose (i.e. Continuous positive airway pressure [CPAP] treatment). While CPAP treatment stops the upper airway from closing in most people, many people have difficulty sleeping with the mask in place and therefore do not use the CPAP treatment. This research study is being conducted to learn whether using a sedative will improve OSA severity by altering some of the traits that are responsible for the disorder.", - "NCTID": "NCT01817907" - }, - { - "brief_title": "Crossover Study With the ProSeal and Supreme Laryngeal Mask Airway", - "phase": "", - "drugs": "['LMA Supreme', 'LMA ProSeal']", - "drugs_list": [ - "LMA Supreme", - "LMA ProSeal" - ], - "diseases": "['Paralysis']", - "diseases_list": [ - "Paralysis" - ], - "enrollment": "94.0", - "inclusion_criteria": "inclusion criteria: \n\n American Society of Anesthesiology physical status grade I-II \n\n Age 18-80 yr \n\n Elective gynecological surgery \n\n Supine position \n\n ", - "exclusion_criteria": ": \n\n Known or predicted difficult airway \n\n Body mass index >35 kg m-2 \n\n Risk of aspiration", - "brief_summary": "The LMA Supreme is a new extraglottic airway device which brings together features of the LMA ProSeal, Fastrach and Unique. We test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProSeal and the LMA Supreme in paralyzed anesthetized patients", - "NCTID": "NCT00626951" - } - ], - "1": [ - { - "brief_title": "TELI TON - Telithromycin in Tonsillitis", - "phase": "Phase 3", - "drugs": "['Telithromycin (HMR3647)', 'Penicillin']", - "drugs_list": [ - "Telithromycin (HMR3647)", - "Penicillin" - ], - "diseases": "['Tonsillitis', 'Pharyngitis']", - "diseases_list": [ - "Tonsillitis", - "Pharyngitis" - ], - "enrollment": "314.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 6 months to less than 13 years of age (<13); \n\n Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on: \n\n A positive result from a rapid detection throat swab test for Group A streptococcal antigen and submission of a throat swab specimen for bacterial culture, identification, and antibiotic-susceptibility testing; and \n\n A sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs: \n\n Tonsil and/or pharyngeal erythema and/or exudate; \n\n Cervical adenopathy; \n\n Uvular edema; \n\n Fever \n\n ", - "exclusion_criteria": ": \n\n Symptoms that collectively suggest nonstreptococcal T/P (eg, laryngitis, coryza, conjunctivitis, diarrhea, cough); \n\n History of positive throat culture for Streptococcus pyogenes in the absence of clinical signs and symptoms of T/P; \n\n Infection of the deep tissues of the upper respiratory tract (eg, epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (eg, sinusitis, otitis media, or orbital/periorbital cellulitis); \n\n History of rheumatic heart disease; \n\n Females of childbearing potential (ie, have reached menarche); \n\n Known congenital prolonged QT syndrome; \n\n Known or suspected uncorrected hypokalemia (\u22643 mmol/L [mEq/L]), or hypomagnesemia or bradycardia (<50 bpm); \n\n Myasthenia gravis; \n\n Known impaired renal function, as shown by creatinine clearance \u226425 mL/min \n\n The subject: \n\n Is being treated with drugs not permitted by the study protocol ie, cisapride, pimozide, astemizole, terfenadine, ergotamine, dihydroergotamine, Class IA (eg, quinidine and procainamide) or Class III (eg, dofetilide) antiarrhythmic agents, simvastatin, lovastatin and atorvastatin; \n\n Is currently being treated with systemic antibacterials or has been treated with systemic antibacterials within 14 days prior to enrollment;- Has been treated with any investigational medication within the last 30 days; \n\n Has been treated with rifampicin, phenytoin, carbamazepine, or St. John's wort within the last 2 weeks. \n\n History of hypersensitivity or intolerance to macrolides, penicillins, or cephalosporins; \n\n Previous enrollment in this study or previous treatment with telithromycin; \n\n Children of the investigator or subinvestigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the protocol.", - "brief_summary": "This is a multinational, randomized (1:1), double blind, double dummy, comparator-controlled, 2 parallel treatment group study in subjects from 6 months to < 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P).Each subject will receive either telithromycin 25 mg/kg once daily for 5 days or penicillin V, 13.3 mg/kg three times daily for 10 days. Matching placebo for telithromycin and penicillin V will also be dispensed for 5 and 10 days respectively, to provide blinding to the different treatment regimens. A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.", - "NCTID": "NCT00315042" - }, - { - "brief_title": "Impact of Anti-inflammatory and Antibiotic Therapy on the Emergence of Peri-tonsillar Abscess", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Abscess, Peritonsillar']", - "diseases_list": [ - "Abscess", - "Peritonsillar" - ], - "enrollment": "711.0", - "inclusion_criteria": "inclusion criteria: \n\n clinical existence of a PLA (phlegmon), validated by a senior ENT, usually (but not necessarily) following a request by an emergency. The visible appearance to the merits throat must justify puncture. Cases will be included whether or not they had consulted for a sore throat in the 10 days preceding the date of diagnosis \n\n ", - "exclusion_criteria": ": \n\n Neoplastic disease of the throat, scalable Hematologic with tonsillar localization History of tonsillectomy", - "brief_summary": "Analyze in children and adults, risk factors in the onset of the APA. The main hypothesis focuses on the use of anti-inflammatory in the context of pharyngitis or sore throat before the symptoms of ABS. Secondary objectives:~- Analyze the implementation of a rapid diagnostic test and its result on the occurrence of an ABS~- Measure the frequency of prescription and describe the reasons for not prescribing an antibiotic for patients who consulted for a sore throat and having developed a PLA~- Describe the microbial flora could puncture of patients hospitalized for APA", - "NCTID": "NCT00954031" - } - ], - "2": [ - { - "brief_title": "Ultrasound and Videofluoroscopy for Diagnosing Swallowing Disorders", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Deglutition Disorder', 'Motor Neuron Disease']", - "diseases_list": [ - "Deglutition Disorder", - "Motor Neuron Disease" - ], - "enrollment": "750.0", - "inclusion_criteria": "inclusion criteria: \n\n Any Clinical Center inpatients and outpatients with known or suspected dysphagia on any other NIH institute protocol can be included for study as well as patients who are admitted specifically for this protocol. \n\n Those patients at risk for oropharyngeal dysfunction will be screened initially by completing a self-assessment swallowing questionnaire, and by an interview with staff and/or family members. Patients who demonstrate appropriate signs and symptoms of dysphagia and oral motor impairment on the screening assessment will be considered for the protocol: \n\n Difficulty swallowing food or pills. \n\n Changed swallowing ability. \n\n Coughing or choking when eating. \n\n Shortness of breath during swallowing. \n\n Food backing up into the mouth or nasal passage. \n\n Fever or voice changes after swallowing. \n\n Pain when swallowing. \n\n Unexplained loss of weight. \n\n ", - "exclusion_criteria": ": \n\n Patients who are severely demented or severely compromised will be excluded if they do not have sufficient cognitive ability to follow directions. \n\n Patients who are non-ambulatory will be excluded if they can not be braced or supported within the fluoroscopy unit. \n\n Highly agitated individuals will also be excluded if they are unable to remain confined in the equipment. \n\n Infants and children under age 3 will be excluded due to radiation risk on the developing visual system.", - "brief_summary": "This study will identify clinical signs and symptoms critical for diagnosing swallowing disorders and will characterize swallowing problems in various patient populations, such as patients with Parkinson's disease, stroke, post-polio syndrome, multiple sclerosis and other conditions that cause swallowing abnormalities.~Patients with swallowing difficulties who are enrolled in NIH neurology or speech pathology protocols may be eligible for this study. Participants will undergo the following procedures:~Oral examination-A neurologist and speech pathologist examine the patient's swallowing function. The patient is interviewed about difficulties with food intake, chewing and swallowing during meals.~Ultrasound examination-Ultrasound creates image of areas inside the body using sound waves. With the patient in a sitting position, a 3/4-inch transducer (device for transmitting and receiving sound waves) is placed under the chin to visualize tongue movements during swallowing.~Modified barium swallow-While standing or sitting, the patient swallows 1/2 teaspoon of flavored barium (a radioactive substance) six times (a total of 3 teaspoons), while the tongue and pharynx (tube leading from the mouth to the esophagus) are scanned and videotaped. The barium is given in three consistencies-thin, medium and thick (pudding-like).~Electromyography-A small plastic strip with wires attached is placed under the patient's chin. The patient then swallows 1/2 ounce of barium three times in a row, and the movement of the chin muscles during swallowing is displayed. Patients may also be asked to swallow 5/8 cup of barium twice; once with the head tilted upward and once with the head untilted.~Depending on the test results, patients may be asked to return for follow-up study and monitoring.", - "NCTID": "NCT00001220" - }, - { - "brief_title": "Penicillin and Metronidazole in Treatment of Peritonsillar Abscess", - "phase": "", - "drugs": "['penicillin and metronidazole in peritonsillar abscess']", - "drugs_list": [ - "penicillin and metronidazole in peritonsillar abscess" - ], - "diseases": "['Peritonsillar Abscess']", - "diseases_list": [ - "Peritonsillar Abscess" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n referring doctor suspects peritonsillar abscess \n\n patient is voluntary \n\n patient has daily access to his/her e-mail \n\n patient speaks and understands Finnish of Swedish \n\n female patients have adequate birth-control method \n\n patient has peritonsillar abscess \n\n ", - "exclusion_criteria": ": \n\n allergy to penicillin \n\n allergy to metronidazole \n\n use of metronidazole in preceding one month \n\n pregnancy \n\n breast-feeding \n\n renal insufficiency \n\n liver insufficiency \n\n alcoholism (drunk at least once a week) \n\n participant in another clinical trial at the moment \n\n treatment of peritonsillar abscess requires in-patient care \n\n tonsillectomy during the next 30 days \n\n army recruit", - "brief_summary": "Treatment of peritonsillar abscess varies. To study whether broad spectrum antibiotics are required in addition to abscess drainage, a prospective, double blind, placebo-controlled, randomized study on 200 adult patients with peritonsillar abscess is performed. 100 patients are given penicillin and metronidazole and 100 patients get penicillin and placebo. Recovery and recurrence are analyzed.", - "NCTID": "NCT01255670" - } - ] - }, - { - "patient_id": "sigir-201514", - "patient": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", - "0": [ - { - "brief_title": "Iron Supplementation Using Total Dose Infusion and Oral Routes for Treatment of Iron Deficiency Anemia in Pregnancy", - "phase": "Phase 4", - "drugs": "['Theragran Hematinic', 'low molecular weight iron dextran']", - "drugs_list": [ - "Theragran Hematinic", - "low molecular weight iron dextran" - ], - "diseases": "['Treatment of Iron Deficiency Anemia in Pregnancy']", - "diseases_list": [ - "Treatment of Iron Deficiency Anemia in Pregnancy" - ], - "enrollment": "212.0", - "inclusion_criteria": "inclusion criteria: \n\n Maternal age 20-35 years old. \n\n Singleton pregnancy between 16 - 24 weeks. \n\n Iron deficiency anemia with average hemoglobin ranging from 7-9 g % at the onset of the study. \n\n ", - "exclusion_criteria": ": \n\n Extremes of reproductive age (less than 20 years old or more than 35 years old). \n\n Patients with multiple pregnancies. \n\n Anemia not linked to iron deficiency. \n\n Allergy to iron derivatives. \n\n Any medical disorder like diabetes or tuberculosis (TB), viral hepatitis cirrhosis, cardiovascular disease, renal disease, autoimmune disease, suspected acute infection, cancer. \n\n Those who had received parenteral iron treatment earlier within 3 months before the start of the study. \n\n Any obstetric complicating factors like pregnancy induced hypertension. \n\n Patients with history of chronic blood loss.", - "brief_summary": "Evaluate the effect of iron supplementation using oral routes in comparison with total dose infusion of low molecular weight iron dextran in iron deficiency anemia during pregnancy.", - "NCTID": "NCT02086838" - }, - { - "brief_title": "To Compare the Efficacy of I.V 200 mg Iron Sucrose and 500 mg Iron Sucrose to Treat Anemia in Pregnancy", - "phase": "", - "drugs": "['Iron sucrose 200 mg', 'Iron sucrose 500 mg']", - "drugs_list": [ - "Iron sucrose 200 mg", - "Iron sucrose 500 mg" - ], - "diseases": "['Pregnancy']", - "diseases_list": [ - "Pregnancy" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Singleton pregnancy \n\n Iron deficiency anemia \n\n Intolerance or low compliance for oral iron \n\n ", - "exclusion_criteria": ": \n\n Known allergy for iron supplements \n\n Anemia not due to iron deficiency \n\n Acute infection \n\n Liver failure or viral hepatitis \n\n Thalassemia or hemoglobinopathies \n\n Asthma \n\n Multiple pregnancy", - "brief_summary": "This study is aimed to compare the efficacy of 2 doses of iron sucrose given intravenously - 200 mg versus 500 mg.", - "NCTID": "NCT02441439" - }, - { - "brief_title": "Rituximab in Auto-Immune Hemolytic Anemia", - "phase": "Phase 3", - "drugs": "['rituximab (Mabthera\u00ae)', 'Placebo']", - "drugs_list": [ - "rituximab (Mabthera\u00ae)", - "Placebo" - ], - "diseases": "['Warm Autoimmune Hemolytic Anemia']", - "diseases_list": [ - "Warm Autoimmune Hemolytic Anemia" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 18 years \n\n AIHA defined at time of diagnosis by a Hgb level \u00a3 10 g/dL, with a reticulocytes count > 120 109/L, signs of hemolysis (at least a haptoglobin level < 4 mg/L), and a positive direct antiglobulin test (DAT) ( IgG or IgG + complement pattern). \n\n Disease duration equal or less than 6 weeks at time of inclusion --> removed by amendment n\u00b04 and substituted by :First episode of AIHA to hot antibody previously untreated or treated corticosteroids for less than 6 weeks. \n\n Patients with an associated autoimmune thrombocytopenia (Evans' syndrome) will be eligible for the study if the platelet count is over 30 x 109/L at inclusion. \n\n Normal level gammaglobulins in the serum (i.e. >5g/L) at inclusion. \n\n Absence of detectable lymph nodes on a total body CT-scan (to be performed before inclusion if not performed at diagnosis). \n\n Effective means of contraception during treatment and for six months after completion of treatment for all women of child bearing age \n\n Negative serum pregnancy test within 14 days prior to study entry. \n\n Written informed consent \n\n ", - "exclusion_criteria": ": \n\n Previous treatment with rituximab \n\n AIHA diagnosed and treated more than 6 weeks prior to inclusion removed by amendment n\u00b04 and substituted by AIHA relapsed or newly diagnosed but treated with corticosteroids for more than 6 weeks \n\n Ongoing immunosuppressive therapy (other than corticosteroids) or previous treatment administered within 2 weeks prior to the beginning of the study treatment \n\n Non-Hodgkin Lymphoma (NHL) other than stage A chronic lymphoid leukemia \n\n Previous or concomitant malignancy other than basal cell or squamous cell carcinoma of the skin, carcinoma-in-situ of the cervix, or other malignancy for which the patient had not been disease-free for at least 5 years. \n\n Autoimmune disorder such as SLE with at least one extra-hematological manifestation requiring a treatment with steroids and/or immunosuppressive drugs. \n\n Any other associated cause congenital or acquired hemolytic anemia (except thalassemia trait or heterozygous sickle cell anemia). \n\n Negative DAT or DAT positive with isolated anti-C3d pattern related to the presence of a monoclonal IgM with cold agglutinin properties. \n\n Positive HIV test and/or hepatitis virus C infection and/or positive hepatitis B virus surface antigen (HbsAg). \n\n Neutrophils count < 1,000/mm 3 at inclusion. \n\n Impaired renal function as indicated by a serum creatinine level > 2 mg/d \n\n Inadequate liver function as indicated by a total bilirubin level > 2.0 mg/dL and/or an AST or ALT level > 2x upper limit of normal. \n\n New York Heart Classification III or IV heart disease. \n\n Previous history of severe psychiatric disorder or are unable to comply with study and follow-up procedures \n\n Pregnant or lactating women, or woman planning to become pregnant within 12 months of receiving study drug \n\n Absence of written informed consent.", - "brief_summary": "The hypothesis based on retrospective data is that, the rate of overall response-rate (PR + CR) at 1 year will be much higher in the rituximab arm (80%) than in the placebo arm (20%).Thirty four patients (17 in each arm) will be include (amendment n\u00b06 - 15/10/2013) over a 3 year period (amendment n\u00b03 - 11/12/2012).", - "NCTID": "NCT01181154" - }, - { - "brief_title": "A Functional Food for the Prevention of Iron-deficiency Anemia", - "phase": "Phase 1", - "drugs": "['Control bread', 'Teff Bread']", - "drugs_list": [ - "Control bread", - "Teff Bread" - ], - "diseases": "['Anemia']", - "diseases_list": [ - "Anemia" - ], - "enrollment": "55.0", - "inclusion_criteria": "inclusion criteria: \n\n Caucasian \n\n Primiparous \n\n Singleton pregnancy (wk 20 to wk 30) \n\n Non smokers \n\n Pre pregnancy BMI between 19.8 and 26 \n\n Healthy, free from iron metabolism disorders (pregnancy induced hypertension \n\n Not taking medicines known to influence iron status \n\n Not taking iron supplements (multivitamins will be accounted for) \n\n Free from gastrointestinal disorders \n\n No allergies \n\n ", - "exclusion_criteria": ": \n\n Pregnancy haemoglobin concentrations are not within the normal range (below 70g/l or over 160g/l)", - "brief_summary": "It has been estimated that 1 in 2 women expecting a baby will be diagnosed with iron deficiency. In turn iron deficiency can affect the health and wellbeing or both mother and child. Studies show that low iron stores prior to conception and low iron intakes during pregnancy may both be contributing to this problem. Although dietary supplements may be one solution, research indicates that daily compliance is low (Nguyen et al., 2008). Furthermore, prescribed iron supplements may result in uncomfortable side-effects, including constipation (Wulff & Ekstrom, 2003).~It is been observed in Ethiopia that iron deficiency anemia is lower than average; a finding that has been attributed to regular Teff consumption (Gies et al., 2003). Teff (Eragrostis tef) is a staple food usually consumed in the form of Enjera (flat bread prepared using a range of cereals). Research has shown that Teff is a rich source of iron that is easily absorbed by the body.~Although it is believed that regular Teff consumption may prevent to onset of iron deficiency anemia there is no research to support this. Therefore, the aim of the present study is to es-tablish whether incorporating Teff into the daily diet may be one way to improve blood profile and prevent the onset of iron deficiency anemia in expectant mothers. Study findings will demonstrate whether Teff may be an alternative source of iron that can be easily incorporated into the daily diet of both pregnant mothers and the lay public.", - "NCTID": "NCT01055431" - }, - { - "brief_title": "Fermented Iron-rich Supplement in Reducing Anemia", - "phase": "Phase 2", - "drugs": "['supplement containing 60 mg iron sulfate', 'iron rich food supplement (60 mg iron)', 'iron rich food supplement (10 mg iron)', 'supplement containing 10 mg iron sulfate']", - "drugs_list": [ - "supplement containing 60 mg iron sulfate", - "iron rich food supplement (60 mg iron)", - "iron rich food supplement (10 mg iron)", - "supplement containing 10 mg iron sulfate" - ], - "diseases": "['Iron Deficiency Anemia']", - "diseases_list": [ - "Iron Deficiency Anemia" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n 18-49 years \n\n Regular menstruation in the last three months \n\n Hemoglobin <12 mg/dl; \n\n Serum Ferittin<20mcg/L \n\n BMI 18.5Kg/m^2 to 29.9 kg/m^2 \n\n ", - "exclusion_criteria": ": \n\n history of gastrointestinal or hematological disorders, \n\n taking medications that could interfere with hematopoiesis or dietary iron absorption \n\n pregnant (based on pregnancy test).", - "brief_summary": "The consequences of iron deficiency anemia in women are enormous, and especially in developing countries, as the condition adversely affects both their productive and reproductive capabilities. The study seeks to: 1) compare changes in iron status indicators among women receiving an iron-rich organic food supplement versus ferrous sulfate supplement, and 2) determine the suitable level of food supplement needed to prevent/reduce iron deficiency anemia among women in developing country settings.~A double-blind, randomized, controlled, intervention trial will be implemented in women of childbearing age, 60 women with iron deficiency anemia and 60 women with iron deficiency. After screening potential subjects (up to 500 expected), approximately 30 will be recruited into each of four study groups; assuming 30% dropout rate, to detect an increase of 30% in ferritin as significant between the two time points at 80% power and alpha value of 0.05. Subjects who meet the inclusion criteria will be randomized into the four groups consisting of: 2 control groups (daily 60mg ferrous sulfate (FS-60) or daily 10mg ferrous sulfate (FS-10)), and 2 test groups (daily 60mg iron-rich supplement (IRS-60) or 10mg iron-rich supplement (IRS-10)). Subjects will take daily FS-60 and IRS-60 under supervision for 8 weeks while subjects taking FS-10 and IRS-10 will take the supplement under supervision for 12 consecutive weeks.", - "NCTID": "NCT02037724" - }, - { - "brief_title": "Relative Bioavailability of Iron and Folic Acid in New Test Supplement", - "phase": "Phase 1", - "drugs": "['Daminaide 995 - SuppleFem Sprinkles', 'Materna']", - "drugs_list": [ - "Daminaide 995 - SuppleFem Sprinkles", - "Materna" - ], - "diseases": "['Iron Deficiency', 'Folic Acid Deficiency']", - "diseases_list": [ - "Iron Deficiency", - "Folic Acid Deficiency" - ], - "enrollment": "18.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy pregnant women between 18 and 45 years of age in the second or third trimester of pregnancy (24-32 weeks of gestational age). \n\n Normal Hb (Hb\u2265110g/L and Hb\u2264144g/L) \n\n ", - "exclusion_criteria": ": \n\n Chronic illness (clinically significant neurological, endocrine, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic diseases) \n\n A history or presence of hemosiderosis, hemochromatosis, peptic ulcer, regional enteritis, ulcerative colitis \n\n A history of or current use of IV iron therapy or erythropoietin therapy \n\n A history or presence of any clinically significant gastrointestinal pathology (eg. chronic diarrhea, inflammatory bowel disease, partial gastrectomy), unresolved gastrointestinal symptoms (eg. diarrhea or vomiting), steatorrhea, or other conditions known to interfere with the absorption, distribution, metabolism or excretion of iron or folic acid \n\n Abnormal hemoglobin electrophoresis ie. sickle cell anemia, thalassemia, etc. \n\n Current acute illness and/or taking antibiotics \n\n Known or suspected allergies to Materna\u00ae, or any ingredient present in Materna or SuppleFem Sprinkles or any of the foods to be consumed during the trial. \n\n Mildly to severely anemic women (Hb<110 g/L) or elevated hemoglobin (above 144g/L) \n\n Complications in pregnancy (including pregnancy induced hypertension, preeclampsia, a history of severe antepartum hemorrhage) \n\n Blood transfusion within last 3 months", - "brief_summary": "Deficiencies of iron and folic acid during pregnancy can lead to adverse outcomes for the fetus, thus supplements are recommended. Adherence to current tablet-based supplements is documented to be poor. Recently a powdered form of micronutrients has been developed which may decrease side-effects and thus improve adherence. However, before testing the efficacy of the supplement as an alternate choice for supplementation during pregnancy, the bioavailability of the iron needs to be determined. The objective of this study is to measure the relative bioavailability of iron and folic acid from a powdered supplement that can be sprinkled on semi-solid foods or beverages versus a traditional tablet supplement in pregnant women.", - "NCTID": "NCT00789490" - }, - { - "brief_title": "Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) Versus Oral Iron for Iron Deficiency Anaemia in Pregnant Women", - "phase": "Phase 3", - "drugs": "['ferrous sulphate', 'Ferinject']", - "drugs_list": [ - "ferrous sulphate", - "Ferinject" - ], - "diseases": "['Anaemia']", - "diseases_list": [ - "Anaemia" - ], - "enrollment": "252.0", - "inclusion_criteria": "inclusion criteria: \n\n Pregnant women aged \u226518, gestational week \u226520, \u226433 at baseline visit with normal antenatal screening test results. \n\n Iron deficiency anaemia defined as Hb concentration \u22658 g/dl and \u226410.4 g/dL and serum ferritin \u226420 mcg/L at screening. \n\n Demonstrated the ability to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments. Patients (or their representative) must provide written informed consent for their participation in the study. \n\n ", - "exclusion_criteria": ": \n\n Blood transfusion, erythropoietin treatment, parenteral iron or oral iron treatment (1 month prior to screening) or anticipated need for a blood transfusion during the study. \n\n Anaemia not caused by iron deficiency (e.g., aplastic, megaloblastic or haemolytic anaemia) or related to acute or ongoing, haemoglobinopathies, rheumatic and other chronic diseases, autoimmune diseases, malignancies, bone marrow diseases, enzyme defects and drug induced anaemia. \n\n Acute or chronic infection, clinically relevant active inflammatory disease (C-reactive protein >10 mg/dl or outside reference range), any acute infection at screening. \n\n Pre-eclampsia. \n\n Multiple pregnancy. \n\n Evidence on any significant abnormalities on anomaly ultrasound. \n\n Haemochromatosis or other iron storage disorders. \n\n Folate deficiency (S-folate <4.5 nmol/L) at screening. \n\n Vitamin B12 deficiency (S-cobalamin <145 pmol/L) at screening. \n\n Serious medical condition, uncontrolled systemic disease or any other medical condition that, in the judgment of the Investigator, prohibits the patient from entering or potentially completing the study. \n\n Known chronic renal failure (defined as creatinine clearance <30 mL/min calculated by Cockcroft-Gault or modification of diet in renal disease formula). \n\n Severe cardiovascular diseases. \n\n Known human immunodeficiency virus/acquired immunodeficiency syndrome, hepatitis B virus or hepatitis C virus infection. \n\n Inability to fully comprehend and/or perform study procedures in the Investigator's opinion \n\n History of endocrine disorders \n\n Ongoing significant neurological or psychiatric disorders including psychotic disorders or dementia \n\n Recent significant bleeding/surgery (within the 3 months prior to screening). \n\n Chronic/acute hepatic disorder or elevating of liver enzymes (aspartate aminotransferase, alanine aminotransferase) over 2 times above the upper normal limit at screening. \n\n Participation in any other interventional study since estimated conception and throughout study participation. \n\n Known hypersensitivity to FCM or other IV iron preparations.", - "brief_summary": "The purpose of this study is to look at how well Ferric Carboxymaltose, an intravenous iron therapy (iron that is infused directly into your body through a vein), compares with ferrous sulphate capsules taken by mouth in the treatment of iron deficiency anaemia during pregnancy.", - "NCTID": "NCT01131624" - }, - { - "brief_title": "Immunopathology of Autoimmune Hemolytic Anemia", - "phase": "", - "drugs": "['blood samples']", - "drugs_list": [ - "blood samples" - ], - "diseases": "['Autoimmune Hemolytic Anemia']", - "diseases_list": [ - "Autoimmune Hemolytic Anemia" - ], - "enrollment": "27.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients diagnosed with primary warm Autoimmune Hemolytic Anemia (wAIHA) \n\n Secondary AHAI (infections, hematological diseases, systemic diseases) \n\n Naive of treatment for hemolytic anemia or in relapse \n\n Older than 16 \n\n Able to understand written and spoken French \n\n who have provided written informed consent \n\n inclusion criteria for CONTROLS \n\n Persons without auto-immune disease, cancer or active infection. \n\n Older than 16 \n\n Able to understand written and spoken French \n\n who have provided written informed consent \n\n ", - "exclusion_criteria": ": \n\n Cold agglutinin disease \n\n Pregnancy \n\n Persons without national health insurance \n\n ", - "brief_summary": "Autoimmune hemolytic anemia (AIHA) is an auto-immune disease mediated by specific antibodies targeting red blood cells. Its pathogenesis is not completely understood, and the role of T cells have been rarely studied.~The aim of this study is to compare the frequency of circulating T cells, T cell polarization and functions, notably regulatory T cells, during warm AIHA by comparison to healthy controls.~The role of treatments, such as steroids, will also be determined in patients with warm AIHA.", - "NCTID": "NCT02158195" - }, - { - "brief_title": "EXTEND EXpanding Treatment for Existing Neurological Disease", - "phase": "Phase 2", - "drugs": "['Hydroxyurea']", - "drugs_list": [ - "Hydroxyurea" - ], - "diseases": "['Sickle Cell Anemia']", - "diseases_list": [ - "Sickle Cell Anemia" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Pediatric participants with a severe form of sickle cell anemia (HbSS, HbS\u03b20 thalassemia, HbSD, HbSOArab) \n\n Age: \u2265 2 and \u2264 17 years of age, at the time of enrollment \n\n Time-averaged maximum velocity (TAMV) TCD Velocity in the conditional (170 - 199 cm/sec) or abnormal (\u2265200 cm/sec) range by Transcranial Doppler ultrasonography examination within 6 months of enrollment, abnormal or conditional TCD velocity and currently on commercial hydroxyurea for primary stroke prevention, or previously enrolled in SCATE, a previous stroke with abnormal or conditional TCD prior to stroke event. \n\n Parent or guardian willing and able to provide informed consent and child gives assent \n\n Ability to comply with study related treatments, evaluations, and follow- up visits \n\n ", - "exclusion_criteria": ": \n\n Inability to take or tolerate daily oral hydroxyurea, including \n\n Known allergy to hydroxyurea therapy \n\n Known positive serology to HIV infection \n\n Known malignancy \n\n Current lactation \n\n Abnormal historical laboratory values (most recent pre-enrollment values unless previously enrolled in SCATE): \n\n Hemoglobin concentration < 6.0 gm/dL \n\n Absolute reticulocyte count < 100 x 109/L with a hemoglobin concentration < 8.0 gm/dL \n\n White Blood Cell (WBC) count < 3.0 x 109/L \n\n Absolute neutrophil count (ANC) < 1.0 x 109/L \n\n Platelet count < 100 x 109/L \n\n Use of therapeutic agents for sickle cell disease (e.g., hydroxyurea, arginine, decitabine, magnesium, chronic transfusions) within 3 months of enrollment unless they have an abnormal TCD velocity and receive commercial hydroxyurea for primary stroke prevention or were previously enrolled in the SCATE study or for secondary stroke prevention in a child with a previous stroke. \n\n Current participation in other therapeutic clinical trials, except SCATE \n\n Known serum creatinine more than twice the upper limit for age AND \n\n 1.0 mg/dL \n\n Any condition or chronic illness, which in the opinion of the clinical investigator makes participation ill-advised \n\n Pregnancy (for post-menarchal females only) \n\n Erythrocyte transfusion within the past 2 months \n\n Previous stem cell transplant or other myelosuppressive therapy (unless they have an abnormal TCD velocity and receive commercial hydroxyurea for primary stroke prevention or for secondary stroke prevention in a child with a previous stroke or were previously enrolled in SCATE)", - "brief_summary": "The primary goal of the Phase II EXTEND trial is to investigate the effects of open-label hydroxyurea treatment, escalated to maximum tolerated dose, for children with Sickle Cell Anemia and either conditional (170 - 199 cm/sec) or abnormal (\u2265200 cm/sec) Transcranial Doppler velocities. The primary endpoint will be measured after 18 months of hydroxyurea but treatment will continue until a common study termination date.", - "NCTID": "NCT02556099" - }, - { - "brief_title": "Impact of Iron/Folic Acid vs Folic Acid Supplements During Pregnancy on Maternal and Child Health", - "phase": "", - "drugs": "['Ferrous Sulfate + folic acid', 'Folic acid']", - "drugs_list": [ - "Ferrous Sulfate + folic acid", - "Folic acid" - ], - "diseases": "['Iron Deficiency', 'Iron Deficiency Anemia']", - "diseases_list": [ - "Iron Deficiency", - "Iron Deficiency Anemia" - ], - "enrollment": "2367.0", - "inclusion_criteria": "inclusion criteria: \n\n uncomplicated singleton pregnancy, first enrollment visit \u2264 20 weeks gestation - \n\n ", - "exclusion_criteria": ": \n\n < 18 years of age \n\n did not live in the county \n\n did not anticipate delivery at participating hospital \n\n were not mentally competent \n\n had a chronic health problem or hemoglobin < 100 g/L at the initial visit \n\n were taking iron at the time.", - "brief_summary": "According to a national study in 2002, the prevalence of ID, IDA, and ID+IDA among pregnant women in China was 42.6%, 9.1%, and 61.7% respectively. A similar study in Hebei province at the same time showed that the prevalence of IDA among pregnant and lactating mothers was 46.39% and 47.21% respectively. There was a significant difference between urban and rural areas. Women living in rural areas had higher chances of having IDA (p<0.01). WHO and UNICEF recommend taking iron, folic acid and multiple micronutrients during pregnancy. However, we don't know much about their influence on maternal and infant health and their clinical effectiveness. Health Department of China recommends taking 400ug folic acid before pregnancy and during early pregnancy. But for various reasons, not all expecting mothers take this advice. Besides, we don't have a national level technical standard of how to take nutrition supplements during pregnancy. Therefore, it's crucial for us to study if iron/folic acid or folic acid only can prevent perinatal complications, as well as their influences on infant and toddler health.~The purpose of this study is to test whether taking iron/folic acid and folic acid only from early pregnancy until delivery will lower the chances of pregnancy complications, and to see how supplements affect gestation results. As well, it will evaluate a) whether taking iron supplement during pregnancy can prevent IDA during pregnancy; b) whether taking iron supplement can increase mother and fetus iron storage; and c) how mother's iron level affects newborn's iron level. We hope to understand nutrition conditions during pregnancy and investigate the relations between pregnancy diet and complications during pregnancy, weight gain during pregnancy, and newborn birth weight. We will evaluate the influence of taking iron and folic acid during pregnancy on the health of infants and toddlers.", - "NCTID": "NCT02221752" - }, - { - "brief_title": "A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia", - "phase": "Phase 2", - "drugs": "['prednisone, low dose rituximab']", - "drugs_list": [ - "prednisone", - "low dose rituximab" - ], - "diseases": "['Autoimmune Hemolytic Disease (Cold Type) (Warm Type)']", - "diseases_list": [ - "Autoimmune Hemolytic Disease (Cold Type) (Warm Type)" - ], - "enrollment": "23.0", - "inclusion_criteria": "inclusion criteria: \n\n Newly diagnosed warm or cold AIHA, defined by symptomatic anemia and positive DAT, in the absence of underlying lymphoproliferative, infectious or neoplastic disease (according to the single Center diagnostic criteria). \n\n Idiopathic warm or cold AIHA relapsed after first line treatment with oral prednisone. \n\n Aged >18 years \n\n ECOG performance status grade 0, 1 or 2 \n\n No psychiatric illness that precludes understanding concepts of the trial or signing informed consent \n\n Patients who have provided written informed consent prior to study participation, with the understanding that the consent may be withdrawn by the patient at any time without prejudice. \n\n ", - "exclusion_criteria": ": \n\n Cell or humoral immunologic deficit (congenital or acquired) \n\n Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent \n\n Active bacterial, viral, or fungal infection requiring systemic therapy HIV or HbsAg positive (with HBV-DNA+) or HCV-Ab positive (with HCV-RNA+) patients \n\n History of malignancies within 3 years prior to study entry \n\n Concomitant immunosuppressive or cytotoxic treatment \n\n Positive pregnancy test. Lactation. \n\n The presence of associated organ-specific autoimmune diseases do not constitute ", - "brief_summary": "The aim of this prospective study was to evaluate the activity, safety and the duration of the response of low dose rituximab associated with standard oral prednisone as first line therapy in newly diagnosed warm autoimmune hemolytic anemia and cold hemagglutinin disease, and as second line therapy in warm autoimmune hemolytic anemia relapsed after standard oral prednisone. Further aim was to correlate the clinical response to biological parameters (cytokine and anti-erythrocyte antibody production in cultures).", - "NCTID": "NCT01345708" - }, - { - "brief_title": "Enhancing Treatment of Iron Deficiency and Iron Deficiency Anemia With an Antioxidant, Vitamin E", - "phase": "Phase 1", - "drugs": "['Vitamin E', 'Placebo']", - "drugs_list": [ - "Vitamin E", - "Placebo" - ], - "diseases": "['Iron Deficiency', 'Iron Deficiency Anemia']", - "diseases_list": [ - "Iron Deficiency", - "Iron Deficiency Anemia" - ], - "enrollment": "44.0", - "inclusion_criteria": "inclusion criteria: \n\n Between 9-24 months of age \n\n Weighed 5.5 lbs or more at birth \n\n Born at 34 week gestation or more \n\n ", - "exclusion_criteria": ": \n\n Consumed infant formula within the past 3 months \n\n Inflammatory bowel disease, cystic fibrosis, liver or kidney disease, cancer, HIV, primary immune deficiencies, anemia unrelated to iron status, chronic blood loss in stool, inherited disorders or iron status, or bleeding or coagulation disorders) \n\n Previous diagnosis of iron deficiency or iron deficiency anemia \n\n Previous treatment of iron deficiency or iron deficiency anemia", - "brief_summary": "The study addresses treatment of iron deficiency, the most common nutritional deficiency that infants and young children encounter. With the knowledge that iron deficiency may irreversibly affect a baby's long-term neurodevelopment and behavior, the investigators are offering free screening blood draws at Children's Hospital Colorado to older babies and toddlers (9-24 months old). If their blood results indicate a serum ferritin of \u2264 15 micrograms/dL without the presence of an elevated C-reactive protein (CRP), they will be invited to continue in the intervention portion of the study, where they will receive iron supplements as well as vitamin E (or placebo) for an eight week treatment period. The rationale for the study is to test whether addition of Vitamin E, an antioxidant and anti-inflammatory agent, improves the treatment response to supplemental iron.", - "NCTID": "NCT01700426" - }, - { - "brief_title": "Doppler or Amniocentesis to Predict Fetal Anemia", - "phase": "Phase 3", - "drugs": "['Fetal Middle Cerebral Artery Doppler measurement']", - "drugs_list": [ - "Fetal Middle Cerebral Artery Doppler measurement" - ], - "diseases": "['Rh Isoimmunization']", - "diseases_list": [ - "Rh Isoimmunization" - ], - "enrollment": "157.0", - "inclusion_criteria": "inclusion criteria: \n\n Pregnant women with red cell alloimmunization associated with a risk of fetal anemia (D, E, c or Duffy (Fya )antibodies, alone or in combination with other antibodies) \n\n Gestational age between 12 and 34 weeks at study entry, viable fetus and accurate dating \n\n Maternal serum test-result, above the threshold at which the fetus is considered to be at risk of developing hemolytic anemia and thus a potential candidate for invasive testing. \n\n ", - "exclusion_criteria": ": \n\n Presence of Kell-antibodies \n\n Presence of fetal hydrops at first ultrasonographic examination \n\n Major fetal congenital or chromosomal anomalies", - "brief_summary": "In pregnancies complicated by Rhesus disease, the mother has developed antibodies which cross the placenta and can cause anemia and death of the fetus. When the anemia is detected on time, the fetus can be saved by giving it blood transfusions during the pregnancy.~The standard test to predict whether the fetus needs a blood transfusion is examination of the amniotic fluid. To obtain this fluid a needle has to be inserted in the womb, which has a risk of preterm delivery, infection, and making the disease worse. This is called amniocentesis.~A new safe test, using Doppler ultrasound, has been developed to possibly replace the amniocentesis.~The aim of this study is to compare the new Doppler test with the standard amniocentesis. If the Doppler test is at least as good, this safe test may replace the amniocentesis in the management of pregnancies with Rhesus disease.", - "NCTID": "NCT00295516" - }, - { - "brief_title": "Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease", - "phase": "Phase 2", - "drugs": "['cyclophosphamide', 'filgrastim']", - "drugs_list": [ - "cyclophosphamide", - "filgrastim" - ], - "diseases": "['Anemia, Hemolytic, Autoimmune', 'Felty Syndrome', 'Purpura, Thrombocytopenic', 'Autoimmune Diseases']", - "diseases_list": [ - "Anemia", - "Hemolytic", - "Autoimmune", - "Felty Syndrome", - "Purpura", - "Thrombocytopenic", - "Autoimmune Diseases" - ], - "enrollment": "32.0", - "inclusion_criteria": "PROTOCOL ENTRY CRITERIA: \n\n --Disease Characteristics-- \n\n Diagnosis of severe autoimmune hematologic disease Autoimmune hemolytic anemia OR Immune thrombocytopenia \n\n Failure of at least 2 standard treatment approaches (e.g., prednisone therapy, splenectomy, intravenous immunoglobulin, or other immunosuppressants) \n\n Inability to taper prednisone dose to less than 10 mg/day OR Autoimmune neutropenia including the following: Felty's syndrome OR Disorders of large granular lymphocytes with recurrent infections or absolute neutrophil count less than 200/mm3 \n\n --Prior/Concurrent Therapy-- \n\n See Disease Characteristics \n\n --Patient Characteristics-- \n\n Age: Not specified \n\n Performance status: Not specified \n\n Hematopoietic: See Disease Characteristics \n\n Hepatic: Not specified \n\n Renal: Creatinine no greater than 2.5 mg/dL \n\n Cardiovascular: Ejection fraction at least 40% \n\n Pulmonary: FVC, FEV1, or DLCO at least 50% predicted \n\n Other: \n\n Not pregnant or nursing \n\n Negative pregnancy test \n\n Fertile patients must use effective contraception \n\n Not preterminal or moribund", - "exclusion_criteria": "", - "brief_summary": "OBJECTIVES:~I. Determine the response rate and 1-year event-free survival in patients with severe autoimmune hematologic disease treated with high-dose cyclophosphamide.", - "NCTID": "NCT00010387" - }, - { - "brief_title": "S. Japonicum and Pregnancy Outcomes", - "phase": "Phase 2", - "drugs": "['Praziquantel', 'Placebo']", - "drugs_list": [ - "Praziquantel", - "Placebo" - ], - "diseases": "['Schistosomiasis']", - "diseases_list": [ - "Schistosomiasis" - ], - "enrollment": "370.0", - "inclusion_criteria": "inclusion criteria: \n\n For screening: \n\n Female, age 18 or over. \n\n Present to a study midwife with suspected pregnancy. \n\n Live in a study village. \n\n For the main study: \n\n Infected with S. japonicum. \n\n Pregnancy as determined by urine pregnancy test. \n\n Age 18 or older. \n\n Participant is otherwise healthy as determined by history, physical exam, ultrasound and laboratory assessment. \n\n Pregnancy between 12-16 weeks gestation. \n\n Ability to provide informed consent to participate. \n\n ", - "exclusion_criteria": ": \n\n Presence of significant disease/illness that is either acute or chronic. This will be defined by history, physical examination, ultrasound and laboratory assessment. In particular: \n\n History of seizures or other neurologic disorder, chronic medical problem determined by history or physical examination, e.g. active hepatitis, tuberculosis, heart disease. \n\n Grade 3 or higher laboratory abnormality of blood urea nitrogen (BUN), Creatinine, bilirubin, white blood cell count, or platelet count will warrant exclusion. Grade 2 or higher abnormality of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) will warrant exclusion. For hemoglobin, women with severe anemia defined as hemoglobin less than 7.0 g/dl will be excluded. \n\n Women with myoma on ultrasound that are sub-mucosal or women with myoma that is in any location and greater than 5 cm in size. \n\n Women with congenital anomalies of the reproductive tract that would be expected to cause decreased fetal weight or greatly increase the risk of prematurity such as duplicate uterus, uterine septum. \n\n For less clear cases, the researchers will define significant illness as one that significantly alters a woman's ability to perform activities of daily living, causes symptoms at least two days per week, or necessitates regular use of medication. In the case of acute medical conditions such as urinary tract infection, pneumonia, febrile illness, enrollment may be postponed until the illness is successfully treated (not currently on any medication for the illness) or the illness self resolves if this occurs before 16 weeks gestation. \n\n Presence of cysts in the eye suggestive of neurocysticercosis. \n\n Regular use of a medication for a chronic medical condition. \n\n History of severe allergic reaction (anaphylaxis, facial swelling, or difficulty breathing) or seizure with praziquantel administration. \n\n Fetus has congenital anomaly determined by 12-16 week ultrasound or is determined to be nonviable (e.g. blighted ovum). \n\n Twin or higher order pregnancy. \n\n Woman has been enrolled into this study for a previous pregnancy. \n\n Inability to comprehend study procedures and provide informed consent due to limited cognitive abilities or other, or refuses to provide informed consent.", - "brief_summary": "The purpose of the study is to understand whether the drug praziquantel (PZQ) is safe for the mother and developing baby when the mother has schistosomiasis (a type of worm) infection, and whether the drug may improve the mother's and baby's health. The usual practice is to wait until after a mother has finished breast feeding before giving the medicine. Approximately 375 infected pregnant women, ages 18 and over, in endemic villages in Leyte, The Philippines will participate. Study volunteers 12-16 weeks pregnant will be given PZQ or an inactive pill (placebo) and stay in the hospital overnight. Small blood samples will be collected before and after the medication is taken. Three stool and urine samples will be taken during a total of 7 study visits. An ultrasound image (picture or outline of the unborn baby) will be performed. When the baby is born, a small blood sample will be taken. Mother and baby will be followed for up to 8 months before the baby is born and 1 month after.", - "NCTID": "NCT00486863" - }, - { - "brief_title": "Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease With Ferrous Sulphate", - "phase": "Phase 4", - "drugs": "['Ferrous sulphate']", - "drugs_list": [ - "Ferrous sulphate" - ], - "diseases": "['Ulcerative Colitis', \"Crohn's Disease\"]", - "diseases_list": [ - "Ulcerative Colitis", - "Crohn's Disease" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with proven iron deficiency anaemia on World Health Organisation (WHO)criteria Patients aged 13 - 18 will be considered adolescents, and aged >18 as adults. \n\n ", - "exclusion_criteria": ": \n\n Anaemia caused by B12 or folate deficiency, or secondary to drugs used to treat IBD; haemoglobinopathies or myelodysplasia; severe cardiopulmonary, hepatic or renal disease; severe cardiopulmonary, hepatic or renal disease; pregnancy and breast feeding females.", - "brief_summary": "Iron deficiency anaemia is common in inflammatory bowel disease (IBD), affecting at least 20% patients at any one time. Hepcidin, a recently described anti-microbial peptide synthesized by the liver, is a key regulator of iron homeostasis. It interferes with absorption of iron into enterocytes, macrophages and hepatocytes by binding to ferroportin. Hepcidin levels rise when total body iron levels rise and protect against iron overload; conversely, in iron deficiency, levels are low. Hepcidin levels also rise under the influence of interleukins (IL)-6 and -1, a factor likely to contribute to iron deficient erythropoesis in active IBD. Whether hepcidin levels predict resistance to oral iron therapy in IBD is unknown, though it may impair its immediate oral absorption. Adult IBD patients who are anaemic report quality of life and fatigue scores comparable to those seen in malignancy.~IBD diagnosed in adolescence interferes with growth, education and employment as well as psychosocial and sexual development. Not surprisingly, adolescents with IBD have a high prevalence of psychological distress, particular depression. Limited historical, and our own data suggest that children and adolescents with IBD are more anaemic than adults, and less often treated with oral iron. What is not clear is whether the apparent under-utilisation of oral iron in paediatric care is because of a perceived lack of benefit or doctors' concerns about possible side effects including worsening disease activity.~To address these questions, the investigators propose a comparative study of 6 weeks of oral iron supplementation in adolescents and adults with iron deficiency anaemia in IBD. Patients will be given oral iron supplementation. Before and after iron therapy, the investigators shall assess haemoglobin concentrations; IBD activity; quality of life (QOL), perceived stress, mood and fatigue; iron metabolism, including serum hepcidin.", - "NCTID": "NCT01991314" - }, - { - "brief_title": "Effect of Vitamin E Supplementation on Hemoglobin Levels in Healthy Adults", - "phase": "Phase 1; Phase 2", - "drugs": "['Vitamin E', 'placebo (edible oil)']", - "drugs_list": [ - "Vitamin E", - "placebo (edible oil)" - ], - "diseases": "['Anemia']", - "diseases_list": [ - "Anemia" - ], - "enrollment": "357.0", - "inclusion_criteria": "inclusion criteria: \n\n mildly anemic (on the basis of screening) volunteer males and non-pregnant and non-lactating females, giving written informed consent. \n\n normolipidemic, normotensive \n\n no history of: i. diabetes, hyperlipidemia, obesity, asthma, cancer, respiratory, cardiovascular, nervous, gastrointestinal, hepatic, urogenital, musculoskeletal, endocrine, psychiatric, sexually-transmitted disease, during the last 5 years. \n\n ii. severe acute or chronic blood loss during last 6 months. iii. bleeding or clotting abnormality during last 1 year. iv. regular cigarette smoking, tobacco chewing v. consumption of vitamin E, vitamin B12, folate, iron or antioxidant during the last 6 months prior to enrollment. \n\n ", - "exclusion_criteria": ": \n\n pregnant and lactating females. \n\n cigarette smoking, tobacco chewing, alcohol consumers \n\n blood transfusions during the last 1 year \n\n history of diabetes mellitus, hypertension, dyslipidemia , obesity asthma, cancer, respiratory, renal, nervous, gastrointestinal, hepatic, urogenital, musculoskeletal, endocrine, psychiatric, cardiovascular disorder/disease during the last five years. \n\n severe acute blood loss during last 6 months. \n\n bleeding or clotting abnormalities during the last 1 year. \n\n consumed vitamin E, B12, folate, iron or antioxidants supplements during the last 6 months.", - "brief_summary": "Anemia is one of the major health problems of the developing countries of the world [1]. According to the WHO reference criteria, an adult is labeled as anemic, if the blood hemoglobin concentration falls below 13.0 g/dL in men or less than 12.0 g/dL in the non-pregnant women [2]. Hemoglobin concentrations below the lower limit of normal are a common laboratory finding in apparently healthy people in general population all over the world [3-5]. Many of these mildly anemic individuals are not investigated sufficiently to establish the probable cause of their anemia and thus may end up with morbidity and health problems, especially the young women in developing countries [4].~Only few studies on the use of vitamin E in the correction of anemia have been published and hardly any on correction of mild anemia in healthy adults. The objective of this intervention study was to investigate the association of vitamin E supplementation with post-supplemental blood hemoglobin levels in mildly anemic healthy Pakistani adults.", - "NCTID": "NCT02181348" - }, - { - "brief_title": "Ferrous Sulphate Supplement in Women With Iron Deficiency Anaemia", - "phase": "Phase 1", - "drugs": "['Tardyferon 80 mg']", - "drugs_list": [ - "Tardyferon 80 mg" - ], - "diseases": "['Iron Deficiency Anemia']", - "diseases_list": [ - "Iron Deficiency Anemia" - ], - "enrollment": "55.0", - "inclusion_criteria": "inclusion criteria: \n\n Women 18-45 years old with iron deficiency anaemia \n\n haemoglobin level between 85 g/L and 105 g/L \n\n serum ferritin level < 15 \u00b5g/L \n\n D14 + 7 days of the menstruation cycle on the day of pharmacokinetic evaluation \n\n Standard diet \n\n ", - "exclusion_criteria": ": \n\n - Anaemia related to other causes than iron deficiency and particularly inflammatory anaemia, anaemia due to marrow failure, haemopathy, haemoglobinopathies (sickle cell disease, thalassemia), haemolytic anaemia, anaemia due to acute haemorrhage, or anaemia related to chronic renal failure, \n\n Haemochromatosis or iron overload of secondary origin (blood transfusion), \n\n Long term treatment known to modify iron absorption, \n\n Gastro duodenal ulcer, \n\n Inflammatory bowel disease or any digestive disease which could modify iron absorption, \n\n Fructose intolerance, syndrome of malabsorption of glucose, galactose, deficit of sucrase-isomaltase, \n\n Serious or progressive disease (cardiac, pulmonary, hepatic, renal, haematological, malignancy, autoimmune disease, infectious disease or neuropsychiatric disorders), \n\n Surgery undergone within 1 month prior to selection visit or a surgery planned during the study realization.", - "brief_summary": "The purpose of this study is to investigate the pharmacokinetics of serum iron (the amount of iron in blood) after single oral administration of 2 tablets of L0008 80 mg (as ferrous sulphate) in women with iron deficiency anaemia.", - "NCTID": "NCT01757119" - }, - { - "brief_title": "the Efficacy and Safety of Vitamin C for Iron Supplementation in Adult IDA Patients", - "phase": "Phase 4", - "drugs": "['ferrous succinate and vitamin C', 'ferrous succinate', 'ferrous succinate']", - "drugs_list": [ - "ferrous succinate and vitamin C", - "ferrous succinate", - "ferrous succinate" - ], - "diseases": "['Anemia, Iron-Deficiency']", - "diseases_list": [ - "Anemia", - "Iron-Deficiency" - ], - "enrollment": "440.0", - "inclusion_criteria": "inclusion criteria: \n\n Hemoglobin (Hb) < 120 g/L in men and Hb < 110 g/L in women; Mean Corpuscular Volume(MCV) < 80 fl, Mean Corpuscular Hemoglobin(MCH) < 27 pg, and Mean Corpuscular Hemoglobin Concentration(MCHC) < 0.32; the blood biochemical examination: serum ferritin < 12 g/L, serum iron < 8.95 mol/L, transferrin saturation <15%, and total iron binding capacity>64.44 mol/L; with a history of Menorrhagia, monophagia or eating disorders; Willing to sign a Informed consent form. \n\n ", - "exclusion_criteria": ": \n\n Pregnant women; drug allergy; the patients with serious gastrorrhagia, other peptic ulcers, active bleeding, hepatic insufficiency, heart disease or renal insufficiency; those patients can't tolerate the medicine orally, or participate in other clinical study, or refuse to sign a Informed consent Form.", - "brief_summary": "IDA patients ofen receive ferrous succinate treatment to speed up the recovery of anemia, the doctor will prescribe ferrous succinate with or without vitamin C according to their own preferences. In theory, only the divalent iron can be absorbed in duodenum and upper jejunum, vitamin C can oxidize ferric iron into divalent iron and maintains a certain degree of acidity in the intestine, and then promotes the absorption of iron. In current clinical practice, it's lack of randomized controlled trial(RCT) about the efficacy and safety of vitamin C for iron supplementation in patients with IDA. In this study, the efficacy and safety of vitamin C for iron supplementation in adult IDA patients are explored by RCT. The dosage regimens of ferrous succinate with or without vitamin C are randomly assigned to patients who meet the inclusion criteria, and these patients are followed up every two weeks. On the one hand, whether the addition of vitamin C can accelerate the recovery of anemia is evaluated, on the other hand, whether the addition of vitamin C can increase the incidence of gastrointestinal tract discomfort is aslo appraised , the discomfort include vomiting, nausea, abdominal pain, diarrhea and constipation. We hypothesis that vitamin C can increase the absorption of iron and accelerate the recovery of anemia, it also increases incidence of gastrointestinal adverse events because of increased iron absorption at the same time.", - "NCTID": "NCT02631668" - }, - { - "brief_title": "Long Term Effects of Erythrocyte Lysis", - "phase": "", - "drugs": "['Clinical Evaluations', 'Laboratory Studies']", - "drugs_list": [ - "Clinical Evaluations", - "Laboratory Studies" - ], - "diseases": "['Sickle Cell Disease', 'Hemolytic Anemia']", - "diseases_list": [ - "Sickle Cell Disease", - "Hemolytic Anemia" - ], - "enrollment": "390.0", - "inclusion_criteria": "inclusion criteria: \n\n Established Diagnosis of Hemolysis \n\n Sickle Cell Disease (e.g., HbSS, HbS/\u03b2-thalassemia, HbSC) \n\n Other conditions with hemolysis (e.g., RBC membranopathies, enzymopathies, unstable hemoglobinopathies, PNH) \n\n Age \n\n SCD participants: 5 years of age up to 19th birthday \n\n All other participants: 5 years of age and up (no age limit) \n\n ", - "exclusion_criteria": ": \n\n Previous cardiac surgery \n\n Known left ventricle dysfunction (i.e. shortening fraction < 28%) \n\n Known right sided congenital heart defect such as atrial septal defect or pulmonary valve stenosis", - "brief_summary": "In this prospective observational trial, participants with chronic hemolysis will be assessed with echocardiogram for elevated tricuspid jet velocity and other evidence of pulmonary hypertension. Participants will have laboratory studies evaluating: severity of hemolysis, splenic function, inflammation, endothelial dysfunction, and hypercoagulability. There will be 3 main categories of participants enrolled in this study: (1) pediatric participants with severe sickle cell disease (SCD) (HbSS, HbS/\u03b2\u00b0 thalassemia ) who are not receiving treatment (e.g., hydroxyurea or chronic transfusions); (2) pediatric participants with other forms of SCD or severe SCD (HbSS, HbS/\u03b2\u00b0 thalassemia) patients being treated with hydroxyurea or chronic transfusions; and (3) pediatric and adult participants with other non-sickling hematological disorders.", - "NCTID": "NCT00842621" - }, - { - "brief_title": "The Optimization of Bioavailability From Iron Supplements: Study 1", - "phase": "", - "drugs": "['Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days', 'Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 days']", - "drugs_list": [ - "Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days", - "Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 days" - ], - "diseases": "['Iron Deficiency', 'Anemia', 'Iron Deficiency Anemia']", - "diseases_list": [ - "Iron Deficiency", - "Anemia", - "Iron Deficiency Anemia" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Female, 18 to 45 years old, \n\n Serum ferritin levels 5.0 mg/L, >1.0 g/L, respectively, \n\n Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement), \n\n Continuous/long-term use of medication during the whole studies (except for contraceptives), \n\n Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration, \n\n Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months, \n\n Earlier participation in a study using stable iron isotopes, \n\n Known hypersensitivity or allergy to iron supplements, \n\n Women who are pregnant or breast feeding, \n\n Intention to become pregnant during the course of the studies, \n\n Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. \n\n Known or suspected non-compliance, drug or alcohol abuse, \n\n Inability to follow the procedures of the studies, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, \n\n Participation in another study with investigational drug within the 30 days preceding and during the present studies, \n\n Enrolment of the investigator, his/her family members, employees and other dependent persons", - "brief_summary": "Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem worldwide, especially in women of reproductive age and young children. Iron supplementation is an effective strategy to prevent and treat ID and IDA. There is a lack of data on iron bioavailability from different supplementation regimens and how to optimize bioavailability in a cost-effective and patient-friendly way. The present study will test whether the fractional and total iron absorption from iron supplements (60 mg) administered daily for 14 days differs from that of iron supplements (60 mg) administered every second day for 28 days. The prevailing serum hepcidin concentration (SHep) is the major determinant of iron absorption and erythrocyte iron utilization. Therefore we will monitor SHep during the whole supplementation period. We hypothesize that the fractional and total iron absorption from the daily administration of 60 mg is lower than that from the administration on every second day due to increased SHep levels when supplements are administered daily.~The study will provide important insights about the optimization of iron bioavailability from different supplementation regimens including the performance of SHep, a key regulator of human iron metabolism.", - "NCTID": "NCT02175888" - }, - { - "brief_title": "Intravenous Ferric Carboxymaltose (Ferinject\u00ae) With or Without Erythropoietin in Patients Undergoing Orthopaedic Surgery", - "phase": "Phase 4", - "drugs": "['Ferinject \u00ae']", - "drugs_list": [ - "Ferinject \u00ae" - ], - "diseases": "['Iron Deficiency Anemia']", - "diseases_list": [ - "Iron Deficiency Anemia" - ], - "enrollment": "75.0", - "inclusion_criteria": "inclusion criteria: \n\n > 18 years of age and signed written informed consent \n\n Patients scheduled to undergo major orthopaedic surgery (hip or knee arthroplasty or back surgery) \n\n 10 g/dl < Hb < 13.0 g/dl for men and 10 g/dl < Hb < 12.0 g/dl for women, at screening ( 3 weeks prior to surgery) \n\n Ferritin < 100 \u03bcg/l or 100-300 with TSat < 20% \n\n ", - "exclusion_criteria": ": \n\n Suspicion of iron overload (Ferritin >300 \u03bcg/l or/and TSAT>50%) \n\n Active severe infection/inflammation (defined as serum CRP > 20 mg/l) or diagnosed malignancy \n\n Folate-and/or Vitamin B12 deficiency (according to local lab reference range) \n\n Known history of hepatitis B/C or HIV-positive \n\n Liver values 3 times higher than normal \n\n Immunosuppressive or myelosuppressive therapy \n\n A concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients. \n\n Pregnancy or lactation \n\n Transfusion within 1 month prior to study inclusion, EPO treatment with in the last 4 weeks, any iron treatment within 4 weeks prior to the inclusion in the trail \n\n Participation in any other therapeutic trial within the previous month \n\n History of thromboembolic events in the family or the patient \n\n Severe peripheral, coronary or carotid artery disease \n\n Bodyweight < 50 kg \n\n Patients not able to understand the German language", - "brief_summary": "Study Design: Single-centre, block randomised, blinded, controlled, phase IIIb, parallel group pilot study.~Primary Objective:~\u2022 To evaluate the effect of the administration of ferric carboxymaltose (Ferinject\u00ae) with or without erythropoietin vs. no treatment (standard therapy) on the preoperative anaemia status in patients undergoing orthopaedic surgery~Secondary Objective:~To gain informations for the design of a possible follow-up study~To evaluate the effect of the administration of ferric carboxymaltose (Ferinject\u00ae) with or without erythropoietin vs. no treatment (standard therapy) on pre- and postoperative Hb levels, iron status, transfusion rate, days until discharge.~To evaluate the tolerability and safety of Ferinject\u00ae~Study Centres:~This is a single centre study~Patients:~A total of 75 completed patients (50 patients in the intravenous iron treatment groups and 25 patients in the no treatment group will be recruited.", - "NCTID": "NCT00706667" - }, - { - "brief_title": "High Dose Ribavirin in the Treatment of Chronic Hepatitis C", - "phase": "Phase 2", - "drugs": "['High ribavirin dose', 'Standard ribavirin dose']", - "drugs_list": [ - "High ribavirin dose", - "Standard ribavirin dose" - ], - "diseases": "['Chronic Hepatitis C']", - "diseases_list": [ - "Chronic Hepatitis C" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female patients aged 18-65 years \n\n Elevated liver enzymes levels \n\n Compensated liver disease \n\n Available liver histology confirming METAVIR F2 fibrosis \n\n Written consent to participation \n\n ", - "exclusion_criteria": " \n\n Age <18, >65 \n\n Prior ribavirin treatment \n\n Intolerance towards ribavirin, PegIFN or erythropoetin \n\n Pregnancy or breast feeding \n\n Relevant cardiovascular or pulmonary disease \n\n Kidney insufficiency (creatinine clearance <50ml/min) \n\n Coinfection with HIV or hepatitis B virus \n\n Hepatic comorbidities (hemochromatosis, Wilson's disease, autoimmune disorders) \n\n Alcohol consumption > 40g/day \n\n Psychiatric disorders \n\n Malignancy (except for basalioma) \n\n Active consumption of illicit drugs \n\n Participation in another trial shorter than 3 months prior to inclusion \n\n Lack of consent", - "brief_summary": "Treatment of patients with chronic hepatitis C infected with genotype 1 hepatitis C virus (HCV) consists of combined peginterferon/ribavirin for 48 weeks. Approximately 50% of patients experience sustained virological response which equals cure. All other patients either do not respond or experience recurrence of HCV virus and chronic hepatitis. Important predictors of successful treatment are sustained dosing of both peginterferon and ribavirin. With regard to the latter, clinical evidence indicates that higher ribavirin doses may in fact even improve treatment outcome. However, high ribavirin doses cause hemolytic anemia which require dose reductions. Recent clinical experience show that erythropoetic growth factors, including erythropoetin, can counteract hemolytic anemia caused by antiviral treatment in chronic hepatitis C patients. Therefore, the current trial aims to test whether higher ribavirin doses adapted to a target plasma concentrations instead of a weight-based dosing result in better healing rates, and whether ribavirin-associated hemolytic anemia can be compensated by concommitant erythropoetin treatment.~Using a randomized, controlled, open-label design, the investigators hypothesize that patients with high ribavirin doses adapted to plasma levels experience better viral clearance than patients treated with standard weight-based ribavirin doses. In addition, the investigators hypothesize that erythropoetin treatment will counteract hemolytic anemia induced by ribavirin thereby allowing maintenance of target plasma concentrations without ribavirin dose reductions.", - "NCTID": "NCT00944684" - }, - { - "brief_title": "Effects of Taking Prenatal Vitamin-mineral Supplements During Lactation on Iron Status and Markers of Oxidation", - "phase": "", - "drugs": "['Iron', 'Iron', 'Placebo']", - "drugs_list": [ - "Iron", - "Iron", - "Placebo" - ], - "diseases": "['Iron Overload', 'Oxidative Stress', 'Iron-deficiency Anemia']", - "diseases_list": [ - "Iron Overload", - "Oxidative Stress", - "Iron-deficiency Anemia" - ], - "enrollment": "114.0", - "inclusion_criteria": "inclusion criteria: \n\n Women less than 4 weeks postpartum \n\n 18 years of age or older \n\n Took prenatal vitamins for at least 3 months during pregnancy \n\n Successfully initiated breastfeeding \n\n ", - "exclusion_criteria": ": \n\n Anemic (Hgb < 110 g/L)", - "brief_summary": "Most breastfeeding women are told by their health care provider to continue taking prenatal vitamins after they give birth. A woman's requirement for iron while breastfeeding is low, yet prenatal vitamins contain a large amount of iron. The purpose of this study is to see if breastfeeding women are getting too much iron when taking prenatal vitamins.", - "NCTID": "NCT01047098" - }, - { - "brief_title": "Transfusion Effects in Myelodysplastic Patients: Limiting Exposure", - "phase": "Phase 4", - "drugs": "['Red Blood Cell transfusion']", - "drugs_list": [ - "Red Blood Cell transfusion" - ], - "diseases": "['Myelodysplastic Syndromes']", - "diseases_list": [ - "Myelodysplastic Syndromes" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n diagnosis myelodysplastic syndrome (primary or secondary) based on cytopenia in at least 1 cell line + dysplasia in 2 cell lines (and no other cause (especially deficiencies)) and a pathologic anatomic diagnosis after bone marrow punction. \n\n refractory anaemia (RA): blood: \u2264 1% blasts, \u2264 1 x 109 monocytes; bone marrow: < 5% blasts, ringed sideroblasts \u2264 15% of the erythroid cells \n\n refractory anaemia with ringed sideroblasts (RARS): blood: \u2264 1% blasts, \u2264 1 x 109 monocytes; bone marrow: < 5% blasts, ringed sideroblasts > 15% of the erythroid cells \n\n refractory anaemia with excess blasts (RAEB): blood: < 5% blasts, \u2264 1 x 109 monocytes; bone marrow: blasts \u2265 5 -\u2264 20% \n\n chronic myelomonocytic leukaemia (CMML): blood: >1 x 109/l monocytes, <5% blasts; bone marrow: blasts < 20%, increase of the monocytic component \n\n erythrocyte transfusion need \n\n working knowledge of the national language \n\n written consent for participating this study (informed consent) \n\n ", - "exclusion_criteria": ": \n\n candidate for bone marrow- or organ transplantation \n\n medication: growth factors (GM-CSF), or EPO \n\n patients who will receive an intensive chemotherapeutic treatment with a cytopenia, expected longer than 2 weeks \n\n refractory anaemia with excess blasts in transformation (RAEB-t): blood: \u2265 5% blasts or Auer rods; bone marrow: or blasts > 20 - < 30% or Auer rods \n\n pregnancy at the moment of inclusion \n\n patients with congenital severe haemolytic anaemia, like thalassemia or sickle cell anaemia \n\n patients with AIDS or a severe congenital or acquired (e.g. iatrogenic) immunological disorder \n\n severe active infections at the moment of inclusion \n\n severe cardiac, pulmonal, neurological, metabolic or psychiatric disease at the moment of inclusion", - "brief_summary": "The goal of this study was to compare a restrictive RBC transfusion policy (a Hb transfusion trigger: 7.2 gr/dl) with a more liberal RBC transfusion policy (a Hb transfusion trigger: 9.6 gr/dl) on physical fatigue.", - "NCTID": "NCT00202371" - }, - { - "brief_title": "Iron Treatment for Young Children With Non-anemic Iron Deficiency", - "phase": "Phase 4", - "drugs": "['Ferrous Sulfate', 'Placebo', 'Dietary counseling']", - "drugs_list": [ - "Ferrous Sulfate", - "Placebo", - "Dietary counseling" - ], - "diseases": "['Non-anemic Iron Deficiency']", - "diseases_list": [ - "Non-anemic Iron Deficiency" - ], - "enrollment": "132.0", - "inclusion_criteria": "inclusion criteria: \n\n Age between 18 and 36 months attending any well child visit \n\n Informed parental consent \n\n ", - "exclusion_criteria": ": \n\n Previously diagnosed: developmental disorder, genetic, chromosomal or syndromic condition, chronic medical condition, (with the exception of asthma and allergies), including chronic anemia, iron deficiency or recent oral iron supplementation or treatment \n\n Prematurity with a gestational age less than 35 weeks; low birth weight less than 2500 grams \n\n Attending the office for an acute illness, such as a viral illness, or other health concern other than well-child assessment \n\n Any contraindications to receiving elemental iron (i.e. NHP [natural health product], comparator or placebo) \n\n The use of any Natural Health Product containing the same medicinal ingredient(s) as the investigational product \n\n English not spoken to the child in the home or in a child care setting", - "brief_summary": "The pre-school years are critical years for children to acquire early learning skills such as language, fine motor and social skills; this is termed early child development. Primary care doctors (family doctors and pediatricians) are in a unique position to identify children with health or developmental problems. Screening is the process of testing healthy people for the earliest signs of health problems, followed by treatment, with the expectation that screening will improve the health of those screened. The focus of this research is screening young children for the earliest signs of iron deficiency (low blood iron levels) followed by treatment with oral iron.~Previous research has shown that children with later stages of iron deficiency have serious delays in their development. Some research has shown that these delays may persist into young adulthood often with a significant reduction in intelligence. Early stages of iron deficiency may be difficult for parents or doctors to detect, and a blood test is usually needed. However, Canadian guidelines do not recommend screening all children for iron deficiency, because there is not enough good quality research to prove that screening is effective.~In this study, the investigators will ask parents to allow their child between the ages of 1 to 3 years to have a blood test for iron levels. If the blood level is low, the child will be randomly assigned to receive either oral iron liquid for 4 months plus diet counseling, or a placebo liquid plus diet counseling. A psychologist will measure each child's early learning ability before and after the treatment. If this approach to screening children's blood iron levels followed by treatment improves children's development, parents and doctors may consider that routine blood screening tests are justified. Overall, this research is an important step to improving the ways in which primary care doctors can ensure that children have the best start to life-long health and achievement.", - "NCTID": "NCT01481766" - }, - { - "brief_title": "The Optimization of Bioavailability From Iron Supplements: Study 2", - "phase": "", - "drugs": "['Single oral iron dose of 120 mg per day for 3 consecutive days', 'Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive days']", - "drugs_list": [ - "Single oral iron dose of 120 mg per day for 3 consecutive days", - "Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive days" - ], - "diseases": "['Iron Deficiency', 'Anemia', 'Iron Deficiency Anemia']", - "diseases_list": [ - "Iron Deficiency", - "Anemia", - "Iron Deficiency Anemia" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Female, 18 to 45 years old, \n\n Serum Ferritin levels <20 \u00b5g/L, \n\n Normal body Mass Index (18.5-25 kg/m2), \n\n Body weight <65 kg, \n\n Signed informed consent \n\n ", - "exclusion_criteria": ": \n\n Anaemia (Hb < 11.7 g/dL), \n\n Elevated c-reactive protein or alpha1 glycoprotein concentrations >5.0 mg/L, >1.0 g/L, respectively, \n\n Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement), \n\n Continuous/long-term use of medication during the whole studies (except for contraceptives), \n\n Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration, \n\n Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months, \n\n Earlier participation in a study using stable iron isotopes, \n\n Known hypersensitivity or allergy to iron supplements, \n\n Women who are pregnant or breast feeding, \n\n Intention to become pregnant during the course of the studies, \n\n Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. \n\n Known or suspected non-compliance, drug or alcohol abuse, \n\n Inability to follow the procedures of the studies, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, \n\n Participation in another study with investigational drug within the 30 days preceding and during the present studies, \n\n Enrolment of the investigator, his/her family members, employees and other dependent persons", - "brief_summary": "Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem worldwide, especially in women of reproductive age and young children. Iron supplementation is an effective strategy to prevent and treat ID and IDA. There is a lack of data on iron bioavailability from different supplementation regimens and how to optimize bioavailability in a cost-effective and patient-friendly way. The daily supplementation with 1-4 mg Fe/kg body weight for 3 months is reported to be the most effective method to rapidly increase iron stores in subjects with ID and IDA. In IDA patients, medical practitioners often prescribe supplementation regimens with 120 mg iron per day split into 2 doses with 60 mg iron, arguing that the splitting would increase iron bioavailability compared with one single high dose. However, there is no scientific evidence for this assumption; to the contrary, results from a recent study suggest that iron bioavailability from a second supplementation dose of iron after a first supplementation dose of iron is impaired due to increased hepcidin levels. To address this bioavailability issue, the present study will determine iron absorption from 120 mg iron administered for 3 consecutive days and compare it with that from 2 doses of 60 mg iron per day administered for 3 consecutive days. The investigators hypothesize that the iron bioavailability from the single daily dose will be lower than that from the 2 doses. By measuring also hepcidin, this study will provide important insights on the iron bioavailability from a single dose of iron and on the same amount iron split into two doses (b.i.d. administration).", - "NCTID": "NCT02177851" - }, - { - "brief_title": "Iron Status and Hypoxic Pulmonary Vascular Responses", - "phase": "", - "drugs": "['Intravenous administration of ferric carboxymaltose', 'Subacute hypoxic exposures']", - "drugs_list": [ - "Intravenous administration of ferric carboxymaltose", - "Subacute hypoxic exposures" - ], - "diseases": "['Lung Hypoxia', 'Pulmonary Arterial Hypertension', 'Iron Deficiency']", - "diseases_list": [ - "Lung Hypoxia", - "Pulmonary Arterial Hypertension", - "Iron Deficiency" - ], - "enrollment": "31.0", - "inclusion_criteria": "inclusion criteria: \n\n Willing and able to give informed consent for participation in the study \n\n Men and women aged 18 years or older and generally in good health \n\n Detectable tricuspid regurgitation on echocardiography during both normoxia and hypoxia enabling measurement of pulmonary arterial pressure \n\n For iron-deficient volunteers: ferritin \u226415microg/L and transferrin saturation <16% \n\n For iron-replete volunteers: ferritin \u226520microg/L and transferrin saturation \u226520% \n\n ", - "exclusion_criteria": ": \n\n Haemoglobin <8.0g/dl \n\n Haemoglobinopathy \n\n Iron overload defined as ferritin >300microg/L \n\n Hypoxia at rest or on walking (SaO2 <94%) or significant comorbidity that may affect haematinics, pulmonary vascular or ventilatory responses, e.g. current infection, a chronic inflammatory condition, known cardiovalvular lesion or pulmonary hypertension, uncontrolled asthma or chronic obstructive pulmonary disease \n\n Exposure to high altitude (>2,500m) within the previous six weeks or air travel >4 hours within the previous week \n\n Iron supplementation or blood transfusion within the previous 6 weeks \n\n Pregnancy or breast feeding", - "brief_summary": "On exposure to hypoxia (low oxygen) the normal response is for pulmonary arterial systolic blood pressure (PASP, blood pressure through the lungs) to increase. We have previously shown that raising iron by giving an infusion of iron into a vein reduces this pressure rise and that lowering iron by giving a drug that binds iron, magnifies this response. This is potentially a clinically important observation since iron-deficient people may be at increased risk of pulmonary hypertension if exposed transiently or permanently to hypoxia due to lung disease or residence at high altitude; furthermore if this were true then intravenous iron could be an important treatment in this patient group in the event of hypoxic exposure. The observed effects of iron on PASP are likely to be because iron levels affect oxygen sensing. Low iron levels make the body behave as if exposed to low oxygen by inhibiting the breakdown of the family of oxygen-sensing transcription factors, 'hypoxia inducible factor' or HIF. This includes one of the body's normal responses to low oxygen levels - raising blood pressure through the lungs.~This study will answer the question (1) do iron-deficient volunteers have a greater rise in PASP with hypoxia than those who are iron-replete, and (2) does giving intravenous iron cause a greater reduction in the rise in PASP in those who are iron-deficient than iron-replete? The purpose of this study is not to test the safety or clinical efficacy of iron which is already known.", - "NCTID": "NCT01847352" - }, - { - "brief_title": "A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)", - "phase": "Phase 2", - "drugs": "['Fostamatinib 150 mg bid']", - "drugs_list": [ - "Fostamatinib 150 mg bid" - ], - "diseases": "['Warm Antibody Autoimmune Hemolytic Anemia']", - "diseases_list": [ - "Warm Antibody Autoimmune Hemolytic Anemia" - ], - "enrollment": "26.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject must have had a diagnosis of primary or secondary warm antibody AIHA. \n\n - Must have failed at least 1 prior treatment regimen for AIHA. \n\n ", - "exclusion_criteria": ": \n\n Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria. \n\n Subject with a platelet count of < 30,000/\u03bcL. \n\n Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable or is not well-controlled on current therapy. \n\n Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure \u2265 130 mmHg, or diastolic blood pressure \u2265 80 mmHg.", - "brief_summary": "The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).", - "NCTID": "NCT02612558" - }, - { - "brief_title": "Improving Multivitamin Supplementation to Pregnant Women", - "phase": "Phase 4", - "drugs": "['Pregvit\u00ae', 'Orifer F\u00ae']", - "drugs_list": [ - "Pregvit\u00ae", - "Orifer F\u00ae" - ], - "diseases": "['Pregnancy', 'Morning Sickness', 'Nausea', 'Vomiting', 'Hyperemesis Gravidarum']", - "diseases_list": [ - "Pregnancy", - "Morning Sickness", - "Nausea", - "Vomiting", - "Hyperemesis Gravidarum" - ], - "enrollment": "1370.0", - "inclusion_criteria": "inclusion criteria: \n\n Any woman who discontinued her standard vitamins due to gastrointestinal symptoms or due to the tablet size, with one ofthe following conditions: \n\n Morning sickness. \n\n Gastrointestinal disorders: Crohn's disease, ulcerative colitis, peptic or duodenal ulcer, irritable colon, celiac disease. \n\n Iron deficiency anemia. \n\n Hypothyroidism. \n\n Depression. \n\n ", - "exclusion_criteria": ": \n\n Women who do not agree to consent to this protocol. \n\n Women with a known hypersensitivity to any of the ingredients of Pregvit\u00ae, or Orifer\u00ae F.", - "brief_summary": "The purpose of this study is to compare the tolerability of Pregvit\u00ae to a common prenatal vitamin (Orifer\u00ae F) among pregnant women with morning sickness or those suffering from a variety of conditions.", - "NCTID": "NCT02300155" - }, - { - "brief_title": "Mean Reticulated Haemoglobin (Hb) Content (RetHe) Analysis of Renal Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['End-Stage Renal Failure', 'Functional Iron Deficiency']", - "diseases_list": [ - "End-Stage Renal Failure", - "Functional Iron Deficiency" - ], - "enrollment": "250.0", - "inclusion_criteria": "inclusion criteria: \n\n Two groups of random routine anonamised blood samples (for use in determinimg a local normal range for the Reticulated Haemoglobin Content [RetHe])will be included in the study: \n\n Normal red blood cell (RBC) Indices (Hb , Haematocrit, Mean Cell Volume ande Mean Cell Haemoglobin Content) ; an attempt will be made to select an equal mixture of men / women and an appropriate age spread to provide a valid control range for the group of test subjects (renal patients) The student Investigator will ask Haematology staff to record minimum details of iron deficient patients and normal test results noted at routine validation [positive identification number (barcode)/ age / sex] - these samples will be coded and additionally analysed for RetHe test. \n\n ", - "exclusion_criteria": ": \n\n All renal patient who have had surgery and / or a Blood Transfusion OR bleeding episodes within the last month prior to the study are excluded as this would interfere with red cell parameters. \n\n All patients < 16 years and >85 years are excluded from the study.", - "brief_summary": "Anaemia is a common complication of Chronic Kidney Disease (CKD) the management of which has been aided by the use of synthetic recombinant human erythropoietin therapy (r-HuEPO). This red cell stimulating agent creates the further complication of Functional Iron Deficiency (FID) where, despite normal iron stores, patients fail to respond to therapy as they do not possess enough available iron to meet the demand of increased red cell production. Effective response to r-HuEPO therapy depends on an appropriate monitoring of 'available' iron levels.~Previous research into the clinical utility of testing for reticulated haemoglobin concentrations (Ret He) instead of Serum Ferritin and Transferrin Saturation analysis has indicated an advantage as an iron deficient prognostic marker however, further knowledge is required on the use of this new laboratory test (RetHe) to predict Functional Iron Deficiency (FID) level and to study it's relationship with responses to therapy.~This proposed study aims to estimate a local working Normal (non deficient) and Iron Deficient Reticulated Haemoglobin Content (RET He) reference range from surplus anonamous samples. Routine monthly blood samples from Pre Dialysis and Haemodialysis patients will be used to evaluate the sensitivity and specificity of the RET He test compared to current laboratory tests and investigate its predictive ability for Functional Iron Deficiency in these patients.~Studying , measuring and statistically analysing the change in the RET He parameters in Haemodialysis and Pre Dialysis patients over 3 months will look for evidence of a direct relationship between RET He values and the patients response to therapy. The data will be used to provide a predictive picture of what levels of RET He indicate Functional Iron Deficiency.~The introduction of this test (RetHe) may provide clinicians with a one sample/one test control over iron therapies and ensure the patient gets the most benefit from erythropoietin therapy.", - "NCTID": "NCT01126905" - }, - { - "brief_title": "Carbon Monoxide Levels and Sickle Cell Disease Severity", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Sickle Cell Disease', 'Sickle Cell Anemia', 'Anemia, Sickle Cell']", - "diseases_list": [ - "Sickle Cell Disease", - "Sickle Cell Anemia", - "Anemia", - "Sickle Cell" - ], - "enrollment": "106.0", - "inclusion_criteria": "ELIGIBILITY CRITERIA: \n\n All volunteer subjects must be at least 18 years of age and have provided informed, written consent for participation in this study. Eligibility in the study is determined prior to enrollment on the basis of the following inclusion and ", - "exclusion_criteria": ". Laboratory values obtained within the preceding 60 days are sufficient for screening purposes. \n\n inclusion criteria for SCD Cohort \n\n Males or females 18 years of age or older \n\n Diagnosis of sickle cell disease (any form; electrophoretic or HPLC documentation is required) \n\n ", - "brief_summary": "Background:~- Some people with sickle cell disease have different health problems than others. This may be related to how easily and frequently the red blood cells break apart in the blood. Researchers want to test breath and blood samples from people with sickle cell disease to look for very small amounts of carbon monoxide, which is produced when red blood cells break apart. They will compare these results with breath samples from healthy volunteers. Studying different levels of carbon monoxide may help predict what health problems a person with sickle cell disease may get. It may also provide more information on possible treatments.~Objectives:~- To study breath carbon monoxide levels and their possible relation to the severity of sickle cell disease.~Eligibility:~Individuals at least 18 years of age with sickle cell disease.~Healthy volunteers who are matched for age, sex, and race with the sickle cell disease group.~Design:~Participants will be screened with a medical history.~Participants with sickle cell disease will provide a blood sample and have a heart function test. They will also breathe into a bag to provide an exhaled breath sample.~Healthy volunteers will provide an exhaled breath sample.~No treatment or care will be provided as part of this study.", - "NCTID": "NCT01547793" - }, - { - "brief_title": "Lapdap and Coartemether for Uncomplicated Malaria", - "phase": "Phase 3", - "drugs": "['Chlorproguanil-dapsone (Lapdap)', 'Lumefantrine-artemether (Coartemether )']", - "drugs_list": [ - "Chlorproguanil-dapsone (Lapdap)", - "Lumefantrine-artemether (Coartemether )" - ], - "diseases": "['Malaria']", - "diseases_list": [ - "Malaria" - ], - "enrollment": "1200.0", - "inclusion_criteria": "inclusion criteria: \n\n presentation at health centre with febrile illness \n\n monoinfection with P falciparum \n\n parasitaemia >=500/microlitre \n\n fever or history of fever \n\n ", - "exclusion_criteria": ": \n\n signs of severe or complicated malaria (persistent vomiting with or without dehydration, history of convulsion during the present illness, inability to sit or stand, parasitaemia >200,000/ul) \n\n severe malnutrition \n\n clinically evident concomitant disease \n\n PCV <20% \n\n history of allergy to the study medications \n\n residence outside the study area and hence difficult to follow up", - "brief_summary": "Lapdap (chlorproguanil-dapsone) is an affordable and effective drug, but patients with glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic effects of the dapsone component of Lapdap; therefore there is a need to evaluate the extent to which the risks associated with the use of the drug in settings without G6PD screening might outweigh the benefits to malaria treatment. The investigators will evaluate, in operational settings, the safety and effectiveness of Lapdap and coartemether (lumefantrine-artemether) for treatment of uncomplicated malaria in patients 6 months to 10 years of age.", - "NCTID": "NCT00118794" - }, - { - "brief_title": "Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia", - "phase": "", - "drugs": "['ferrous sulphate (drug)']", - "drugs_list": [ - "ferrous sulphate (drug)" - ], - "diseases": "['Schistosomiasis', 'Helminthiases', 'Anaemia']", - "diseases_list": [ - "Schistosomiasis", - "Helminthiases", - "Anaemia" - ], - "enrollment": "480.0", - "inclusion_criteria": "inclusion criteria:all schoolchildren, in grade 2 and 3, at four selected schools - \n\n ", - "exclusion_criteria": ": \n\n -", - "brief_summary": "The objectives of this study is:~to establish the coverage rate of weekly iron supplementation in children in intervention schools over a period of nine months~document any side effects of weeekly iron supplementation among children in intervention schools over a period of nine months asses the feasibility of incorporating the weekly iron supplementation programme into the normal school activity in intervention schools determine the extent of acceptability and support for the iron supplementation programme by staff at the health centre nearest to the intervention schools~compare the praziquantel efficacy and schistosomiasis reinfection in children in intervention schools with that of children in control schools following the introduction of weekely iron supplementation over a period of nine months~determine the impact of weekly iron supplementation on haemoglobin levels of children in intervention schools and compare with children in control schools over a period of nine months", - "NCTID": "NCT00276224" - }, - { - "brief_title": "Etanercept (Enbrel) for Juvenile Myelomonocytic Leukemia", - "phase": "Phase 2", - "drugs": "['Etanercept']", - "drugs_list": [ - "Etanercept" - ], - "diseases": "['Leukemia']", - "diseases_list": [ - "Leukemia" - ], - "enrollment": "1.0", - "inclusion_criteria": "inclusion criteria: \n\n All children greater than 6 months of age and less than 18 years of age with newly-diagnosed previously untreated or previously diagnosed JMML, which has reoccurred after treatment with chemotherapy, stem cell transplantation, and/or cis-retinoic acid. \n\n A diagnosis of JMML is confirmed only if the following criteria for JMML are met: a) ALL of the following: Absence of t(9;22) or BCR-ABL by PCR or FISH; Absolute monocyte count >1000 (1 X 109/\u00b5L); <20% bone marrow blasts; b) At least 2 of the following: Elevated Hb F hemoglobin; Myeloid precursors in peripheral blood; WBC >10,000 (10 X 109/\u00b5L); GM-CSF hypersensitivity in methylcellulose culture of bone marrow progenitors cells. \n\n Adequate hepatic function (bilirubin equal or less than 2.0 mg/dl; ALT equal or less than 3x normal) \n\n Adequate renal function (serum creatinine equal or less than 2 x normal) \n\n Performance Status: Have a Karnofsky score >50. \n\n Written, informed consent according to institution guidelines. \n\n ", - "exclusion_criteria": ": \n\n Pregnant or lactating. \n\n Receiving any other chemotherapy. Patients must have been off chemotherapy for at least 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment. \n\n Febrile neutropenia at study entry.", - "brief_summary": "Primary Objectives:~1.1 Estimate rate of response and define acute toxicity to etanercept used in an up-front phase II window in newly diagnosed or relapsed JMML.~1.2 Determine if response to Tumor Necrosis Factor (TNF) blockade correlates with genetic basis of Juvenile Myelomonocytic Leukemia (JMML) [mutations in NF1, Ras, SHP2] or levels of TNFa.~1.3 Determine if TNF blockade by etanercept results in inhibition of free levels of TNFa and other cytokines by ELISA and bioassay and improves blood counts.~1.4 Estimate the two year event free survival and overall survival in JMML patients following etanercept and allogeneic hematopoietic stem cell transplantation.", - "NCTID": "NCT00509600" - } - ], - "1": [ - { - "brief_title": "Bovine Lactoferrin to Prevent and Cure Iron Deficiency and Iron Deficiency Anemia in Complicated Pregnancies", - "phase": "Phase 4", - "drugs": "['Lattoglobina (Grunenthal) containing bLf', 'FerroGrad by Abbott']", - "drugs_list": [ - "Lattoglobina (Grunenthal) containing bLf", - "FerroGrad by Abbott" - ], - "diseases": "['Iron Deficiency', 'Iron Deficiency Anemia', 'Pregnancy']", - "diseases_list": [ - "Iron Deficiency", - "Iron Deficiency Anemia", - "Pregnancy" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n pregnant women with one of genetic thrombophilia markers as factor V Leiden, prothrombin 20210A mutation, antiphospholipid antibodies, hyperhomocysteinemia and deficiencies of antithrombin, protein C, or protein S. \n\n pregnant women affected by HT and suffering of iron deficiency (ID) and iron deficiency anemia (IDA) \n\n different trimester of pregnancy \n\n previous miscarriage/s \n\n previous preterm delivery/ies \n\n iron disorders as iron deficiency and iron deficiency anemia are defined by the number of red blood cells <4.000.000/mL, the hemoglobin concentration \u2264 11 g/dL, the total serum iron \u2264 30 mg/dL and serum ferritin \u226412 ng/mL. \n\n ", - "exclusion_criteria": ": \n\n absence of iron deficiency and iron deficiency anemia \n\n non-pregnant women \n\n uncomplicated pregnancies \n\n no informed consent \n\n other treatments of iron supplementation \n\n recent blood transfusion \n\n other concomitant diseases \n\n ascertained allergy to milk proteins or to iron products.", - "brief_summary": "The purpose of this study is to determine whether bovine lactoferrin is effective in preventing and curing iron deficiency and iron deficiency anemia in Hereditary Thrombophilia affected women during pregnancy.~The proposed clinical trial is considered as PHASE IV because in Italy bLf is commercialized by Grunenthal, as Lattoglobina\u00ae (capsules with 100 mg of bLf), to prevent and cure iron deficiency and iron deficiency anemia in pregnant women.", - "NCTID": "NCT01221844" - }, - { - "brief_title": "Early Detection of Anaemia During the Maternity", - "phase": "Phase 3", - "drugs": "['dosage of the NFS and iron']", - "drugs_list": [ - "dosage of the NFS and iron" - ], - "diseases": "['Anemia']", - "diseases_list": [ - "Anemia" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n Every patient followed at the HME at the beginnig of the pregnancy \n\n ", - "exclusion_criteria": ": \n\n pregnency women who don't speak french \n\n pregnancy women affected by b\u00e9ta thalassemia \n\n pregnancy woman having had a p\u00e9riconceptionnel treatment against the anaemia", - "brief_summary": "Estimate the efficiency of a strategy of premature screening of the maternal anaemia during the first quarter of pregnancy versus the usual strategy of screening of the anaemia during the sixth month.", - "NCTID": "NCT00827463" - }, - { - "brief_title": "Effectiveness of LNS and MNP Supplements to Prevent Malnutrition in Women and Their Children in Bangladesh", - "phase": "", - "drugs": "['LNS-PLW', 'LNS-Child', 'MNP', 'IFA']", - "drugs_list": [ - "LNS-PLW", - "LNS-Child", - "MNP", - "IFA" - ], - "diseases": "['Malnutrition']", - "diseases_list": [ - "Malnutrition" - ], - "enrollment": "4011.0", - "inclusion_criteria": "inclusion criteria: \n\n Gestational age \u2264 20 weeks \n\n Planning to remain in the study area during pregnancy and the following three years (i.e., a permanent resident of the study area) \n\n ", - "exclusion_criteria": ": \n\n Pregnancy identified and registered in the CHDP program before the beginning of the enrollment.", - "brief_summary": "The program effectiveness study aims to assess the effect of a lipid-based nutrition supplement (LNS) and micronutrient powder (MNP) provided in a programmatic context for improving maternal nutritional status during pregnancy and lactation (LNS only), and preventing malnutrition in infants and young children (LNS and MNP) in Bangladesh.", - "NCTID": "NCT01715038" - } - ], - "2": [ - { - "brief_title": "Use of Cast Iron Pots to Improve Maternal Anemia", - "phase": "", - "drugs": "['Cast Iron Pot', 'Alumnium Pot']", - "drugs_list": [ - "Cast Iron Pot", - "Alumnium Pot" - ], - "diseases": "['Iron-deficiency Anemia']", - "diseases_list": [ - "Iron-deficiency Anemia" - ], - "enrollment": "34.0", - "inclusion_criteria": "inclusion criteria: \n\n Pregnant women of any age in their first trimester of pregnancy with anemia defined as a Hemoglobin less than 11 and/or a hematocrit less than 33 \n\n Willingness and ability to cook in provided cast iron pot at least 3x/week \n\n Singleton gestations \n\n ", - "exclusion_criteria": ": \n\n Any secondary cause of anemia including inherited and acquired hemolytic anemias (sickle cell disease, thalessemia, malaria, etc) Inability or unwillingness to try to use cast iron pot approximately 3x/week \n\n Women with severe chronic illness and high likelihood of preterm birth and/or expected long-term hospitalizations during pregnancy. Multifetal gestations", - "brief_summary": "Anemia of pregnancy is defined as a hemoglobin concentration of less than 11 g/dL in the first and third trimesters, and less than 10.5 g/dL in the second trimester. The rates of anemia are variable and depend largely on preexisting iron stores and supplementation. Estimates from the World Health Organization report that 35% to 75% of pregnant women in developing countries and 18% of women from industrialized countries are anemic. Maternal anemia is associated with an increased risk of preterm birth, low birthweight, and small for gestational age infants. Many studies have shown improvement in these outcomes with maternal iron supplementation in cases of iron-deficiency anemia. Mounting evidence also indicates that maternal iron deficiency in pregnancy reduces fetal iron stores, perhaps well into the first year of life.~Anemia in pregnancy can also impact maternal morbidity and mortality. Viteri reported that anemic pregnant women are at greater risk of death during the perinatal period and that anemia is the major contributory or sole cause of death in 20-40% of the 500,000 maternal deaths per year.~The need for iron averages close to 1000mg in a typical singleton gestation. This amount considerably exceeds the iron stores of most women and will result in iron-deficiency anemia unless supplemental iron is taken. One problem with iron supplement use is compliance, secondary to adverse effects such as constipation and nausea. Research on the use of cast iron pots in decreasing the incidence of iron-deficiency anemia in non-pregnant women has been promising. These studies have demonstrated good compliance with no reported adverse effects. The aim of our study is to determine if providing anemic women in the first trimester of pregnancy with a cast iron pot will decrease the incidence of anemia later in pregnancy.~Hypothesis: Cooking in cast iron pots will increase hematocrit levels in pregnancy.", - "NCTID": "NCT02341300" - }, - { - "brief_title": "Relative Contributions of Red Cell Catabolism and Dietary Absorption to Fetal Iron Accretion During Pregnancy", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Iron Deficiency']", - "diseases_list": [ - "Iron Deficiency" - ], - "enrollment": "23.0", - "inclusion_criteria": "inclusion criteria: \n\n Singleton pregnancy \n\n Non-smoker \n\n No pre-existing medical complications (such as HIV-infection, eating disorders, hemoglobinopathies, malabsorption diseases, steroid use, substance abuse history, or taking medications known to influence iron homeostasis) \n\n ", - "exclusion_criteria": ": \n\n Complicated pregnancy (including gestational diabetes, pregnancy-induced hypertension, or preeclampsia) \n\n Individuals been previously treated for lead exposure, or those that have been identified as having elevated blood lead concentrations during childhood, will be excluded from the study", - "brief_summary": "The two specific aims of this study are 1) to assess the relative contributions of two major maternal iron sources (i.e. dietary iron intake and red cell catabolism) at supplying iron to the fetus, and 2) to determine the impact of maternal and fetal iron status on placental transfer of these two iron sources in pregnant women and adolescents during the last trimester of pregnancy.", - "NCTID": "NCT01588665" - }, - { - "brief_title": "Prenatal Iron and Malaria Study", - "phase": "Phase 4", - "drugs": "['iron']", - "drugs_list": [ - "iron" - ], - "diseases": "['Malaria']", - "diseases_list": [ - "Malaria" - ], - "enrollment": "470.0", - "inclusion_criteria": "inclusion criteria: \n\n Women aged 15-45 years resident in the predefined study area \n\n Pregnant, with gestational age <23 weeks \n\n ", - "exclusion_criteria": ": \n\n Failure to provide a blood sample \n\n Initial haemoglobin concentration <90 g/L \n\n Reported medical history suggestive of sickle cell anaemia, epilepsy, diabetes \n\n Obstetric history suggestive of eclampsia or pre-eclampsia \n\n Obvious mental retardation or metabolic disorder; \n\n No written consent \n\n Carrying multiples \n\n Woman planning to leave the homestead or to be absent for prolonged periods in the course of the pregnancy or within a 1-month period thereafter \n\n Woman planning to deliver outside the research clinic.", - "brief_summary": "The purpose of this study is to compare the presence of Plasmodium infection in parturient women who antenatally received a combination of iron-fortified foods with iron supplements versus iron-fortified foods only.", - "NCTID": "NCT01308112" - } - ] - }, - { - "patient_id": "sigir-201515", - "patient": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", - "0": [ - { - "brief_title": "Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke", - "phase": "", - "drugs": "['Reveal LINQ Insertable Cardiac Monitor']", - "drugs_list": [ - "Reveal LINQ Insertable Cardiac Monitor" - ], - "diseases": "['Ischemic Stroke']", - "diseases_list": [ - "Ischemic Stroke" - ], - "enrollment": "53.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with a recent ischemic stroke or transient ischemic attack (TIA) with brain infarction on brain imaging. \n\n No history of atrial fibrillation or finding of atrial fibrillation on standard inpatient monitoring (electrocardiogram, telemetry, 24-hour Holter monitor) \n\n Have a presumed stroke etiology: Lacunar or small vessel thrombosis, extra-cranial or intracranial atherosclerotic stenosis or dissection, arteriopathy or vasculitis, hypercoagulable state, aortic arch plaque with or without mobile elements, or evidence of a low-risk cardiac source (e.g., patent foramen ovale with or without atrial septal aneurysm and with or without evidence of venous thromboembolic source). \n\n Have virtual CHADS2 score \u22653 or \n\n Have 2 or more of the following co-morbidities: obstructive sleep apnea, coronary artery disease, (Chronic Pulmonary Obstructive Disease (COPD), hyperthyroidism, Body Mass Index> 30, prior myocardial infarction, prolonged PR interval (>175 ms) or renal impairment (GFR 30-60). \n\n Patient or legally authorized representative who is willing to sign written consent form. \n\n Patient is \u226540 years old (patients younger than 40 years old have a very low likelihood of having atrial fibrillation and are therefore excluded from the study). \n\n Patient can have the device implanted within 7 days of the incident ischemic event \n\n ", - "exclusion_criteria": ": \n\n Documented history of AF or atrial flutter. \n\n Evidence of a high-risk cardiac source of embolism (Left Ventricular or Left Atrial thrombus or smoke, emboligenic valvular lesion or tumor) \n\n Untreated hyperthyroidism. \n\n Myocardial infarction or coronary bypass grafting within 1 month prior to the stroke/TIA. \n\n Valvular disease requiring immediate surgical intervention. \n\n Permanent indication for anticoagulation at enrollment. \n\n Permanent oral anticoagulation contraindication. \n\n Already included in another clinical trial that will affect the objectives of this study. \n\n Life expectancy is less than 1 year. \n\n Pregnancy. Urine or serum pregnancy test is required for women of child bearing potential to exclude pregnancy. \n\n Patient is indicated for implant with a pacemaker, implantable cardioverter-defibrillator, CRT device, or an implantable hemodynamic monitoring system \n\n Patient is not fit, or is unable or unwilling to follow the required procedures of the Clinical Investigation Plan. \n\n Cryptogenic Stroke: A stroke/TIA will be considered cryptogenic if no cause is determined despite extensive inpatient workup according to the standard diagnostic protocol at North Shore University Hospital.", - "brief_summary": "The purpose of this study is to determine the incidence of paroxysmal atrial fibrillation (AF) in ischemic stroke patients who have a presumed known stroke etiology other than atrial fibrillation.", - "NCTID": "NCT02232022" - }, - { - "brief_title": "Ischemia Care Biomarkers of Acute Stroke Etiology (BASE)", - "phase": "", - "drugs": "['Biomarker blood draw']", - "drugs_list": [ - "Biomarker blood draw" - ], - "diseases": "['Ischemic Stroke', 'Atrial Fibrillation', 'Transient Ischemic Attacks', 'Transient Cerebrovascular Events', 'Thrombotic Stroke', 'Stroke of Basilar Artery', 'Cardioembolic Stroke']", - "diseases_list": [ - "Ischemic Stroke", - "Atrial Fibrillation", - "Transient Ischemic Attacks", - "Transient Cerebrovascular Events", - "Thrombotic Stroke", - "Stroke of Basilar Artery", - "Cardioembolic Stroke" - ], - "enrollment": "1750.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients >18 years of age \n\n Signs and symptoms suggestive of AIS or TIA \n\n One of the following: \n\n BASE - Arrival to the emergency department or hospital within 18 hrs of symptom onset or last known normal time \n\n BASE 24 - Arrival to the emergency department or hospital within 24 hours +/- 6 hours (i.e. 18 - 30 hour window) of symptom onset or last known normal time and clinical evidence suggesting Acute Ischemic Stroke. \n\n Head CT or MRI ruling out other pathology such as vascular malformation, hemorrhage, tumor or abscess which would likely be responsible for presenting neurologic symptoms \n\n Informed consent obtained \n\n ", - "exclusion_criteria": ": \n\n Any central nervous system infection, i.e. meningitis or encephalitis in the past 30 days \n\n Any form of head trauma, stroke or intracranial hemorrhage in the past 30 days \n\n Known primary or metastatic cancer involving the brain \n\n Active Cancer defined as a diagnosis of cancer, within 6 months before enrollment, any treatment for cancer within the previous 6 months, or recurrent or metastatic cancer. \n\n Autoimmune diseases: such as lupus, rheumatoid arthritis, Crohn's disease, ulcerative colitis \n\n Active infectious diseases (eg. HIV/AIDS, hepatitis C) \n\n Any underlying medical condition which in the opinion of the investigator would prohibit the patient from providing informed consent \n\n Major surgery within three months prior to the index event", - "brief_summary": "The proposed study will validate the clinical use of new biomarker blood tests to identify blood components that may differentiate between diverse stroke etiologies and clinical outcomes as listed below:~Differentiate between cardioembolic and large artery atherosclerotic ischemic strokes, when hemorrhagic stroke is ruled out.~In cases of ischemic strokes of unknown or cryptogenic etiology, determine the ability of biomarker blood tests to predict etiology between cardioembolic and large artery atherosclerotic.~In cases of cardioembolic ischemic stroke, further differentiation of cardioembolic ischemic strokes into those caused by atrial fibrillation (AF) and those not caused by AF.~Differentiate transient ischemic attacks (TIAs) from acute ischemic strokes.~Differentiate TIAs from non-ischemic transient neurological events (TNE) with similar symptoms.", - "NCTID": "NCT02014896" - }, - { - "brief_title": "Atrial Fibrillation and Premature Atrial Complexes in Patients With Ischemic Stroke.", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Stroke', 'Atrial Fibrillation', 'Premature Atrial Complexes']", - "diseases_list": [ - "Stroke", - "Atrial Fibrillation", - "Premature Atrial Complexes" - ], - "enrollment": "264.0", - "inclusion_criteria": "inclusion criteria: \n\n admitted with ischemic stroke at a single center \n\n time from diagnose to inclusion maximum 7 days. \n\n written informed consent or surrogate informed consent eligible \n\n age > 18 years. \n\n ", - "exclusion_criteria": ": \n\n hemorrhagic stroke \n\n terminal illness and expected lifespan of less than 6 months. \n\n any physical or mental condition which make the patients unsuitable for participation in the study. \n\n known with a pacemaker \n\n anticoagulation treatment of other reasons than atrial fibrillation.", - "brief_summary": "The purpose of this study is to improve secondary prevention of ischemic stroke patients by~Estimating prevalence and the prognostic significance of frequent premature atrial complexes in ischemic stroke patients in relation to death, recurrent stroke and atrial fibrillation.~Characterize ischemic stroke patients by~Echocardiographic characteristics~Biochemical markers~Plaque composition in the carotid arteries~in order to improve risk stratification.", - "NCTID": "NCT02180542" - }, - { - "brief_title": "Home Monitoring in the Management of Hypertension and Diabetes Mellitus", - "phase": "", - "drugs": "['Home monitoring']", - "drugs_list": [ - "Home monitoring" - ], - "diseases": "['Hypertension', 'Type 2 Diabetes Mellitus']", - "diseases_list": [ - "Hypertension", - "Type 2 Diabetes Mellitus" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Regardless of whether they are currently receiving antihypertensive therapy, systolic blood pressure higher than 140 mmHg or diastolic blood pressure higher than 90 mmHg. \n\n Whether or not use oral hypoglycemic agents or insulin injections, the fasting plasma is higher than 7.0 mmol/L, or postprandial blood glucose higher than 11.1 mmol/L. \n\n ", - "exclusion_criteria": ": \n\n With life-threatening disease. \n\n With the various effects of metabolic diseases such as hyperthyroidism, hypothyroidism, etc. \n\n Stroke, myocardial infarction and other serious cardiovascular and cerebrovascular diseases occurred within 3 months. \n\n Serum creatinine level higher than 176.8 mmol/L \n\n Dementia or severe cognitive decline \n\n Unable to do a long-term follow-up or do not agree to participate in this trial.", - "brief_summary": "The home monitoring of automated measuring devices may improve the management of the chronic diseases, and may decrease the incidence of fatal disease. The investigators conducted a small sample and short observation time research to explore the feasibility to carry out later large-scale research.", - "NCTID": "NCT00968786" - }, - { - "brief_title": "Retrospective Treatment Pattern Survey for the Patient With and Without History of Stroke", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "1000.0", - "inclusion_criteria": "inclusion criteria: \n\n Outpatients attending neurology specialty centers, either with or without history of stroke, receiving hypertension medication \n\n ", - "exclusion_criteria": ": \n\n Secondary hypertension patients \n\n Patients not receiving hypertension medication", - "brief_summary": "This study will compare hypertension treatment pattern of stroke patients with non-stroke patients receiving medical care from outpatient clinics at neurology specialty centers in Korea. It will evaluate target BP achievement rate in patients with stroke compared to patients without stroke and investigate factors affecting BP target goal efficacy in these patients.", - "NCTID": "NCT00785057" - }, - { - "brief_title": "LAA Excision With AF Ablation Versus Oral Anticoagulants for Secondary Prevention of Stroke", - "phase": "", - "drugs": "['Thoracoscopic LAA Excision plus AF Ablation', 'Warfarin or Novel Oral Anticoagulants']", - "drugs_list": [ - "Thoracoscopic LAA Excision plus AF Ablation", - "Warfarin or Novel Oral Anticoagulants" - ], - "diseases": "['Atrial Fibrillation', 'Stroke', 'Systemic Embolism']", - "diseases_list": [ - "Atrial Fibrillation", - "Stroke", - "Systemic Embolism" - ], - "enrollment": "474.0", - "inclusion_criteria": "inclusion criteria: \n\n 18-80 years \n\n Have documented AF episodes \n\n The occurrence of ischemic stroke, TIA or systemic thromboembolism at least one month before enrollment \n\n Capable of understanding and signing the CRF \n\n ", - "exclusion_criteria": ": \n\n Reversible AF \n\n Modified Rankin score \u22654 \n\n Having a history of rheumatic, severe valvular heart disease or heart valve replacement \n\n Having symptomatic carotid artery disease \n\n Having another disease which requires lifelong warfarin therapy \n\n Medical conditions limiting expected survival to <1 year \n\n Women of childbearing potential (unless post-menopausal or surgically sterile) \n\n Participation in any other clinical mortality trial \n\n Unable to give informed consent", - "brief_summary": "This cohort study aims to evaluate thoracoscopic left atrial appendage excision plus atrial fibrillation ablation versus oral anticoagulants for the prevention of stroke and non-central nervous systemic embolism in patients with atrial fibrillation and thromboembolism.", - "NCTID": "NCT02478294" - }, - { - "brief_title": "PFO ACCESS Registry", - "phase": "", - "drugs": "['Device closure with the AMPLATZER PFO Occluder']", - "drugs_list": [ - "Device closure with the AMPLATZER PFO Occluder" - ], - "diseases": "['Patent Foramen Ovale', 'Stroke']", - "diseases_list": [ - "Patent Foramen Ovale", - "Stroke" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Patent foramen ovale (PFO); recurrent cryptogenic stroke; failed antiplatelet/anticoagulant therapy \n\n ", - "exclusion_criteria": ": \n\n International normalized ration (INR) outside of 2-3; intracardiac thrombus (subjects may be enrolled after resolution of thrombus)", - "brief_summary": "Closure of Patent Foramen Ovale with the AMPLATZER\u00ae PFO OCCLUDER in patients with at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional therapy.", - "NCTID": "NCT00583401" - }, - { - "brief_title": "Subclinical AtrIal FibrilLation and StrokE PreveNtion Trial", - "phase": "Phase 4", - "drugs": "['Anticoagulant']", - "drugs_list": [ - "Anticoagulant" - ], - "diseases": "['Atrial Fibrillation']", - "diseases_list": [ - "Atrial Fibrillation" - ], - "enrollment": "2054.0", - "inclusion_criteria": "inclusion criteria: \n\n Age >= 18 years \n\n CHADS2 score >=2 \n\n Sinus rhythm \n\n Cardiac Implantable Electronic Device \n\n ", - "exclusion_criteria": ": \n\n Atrial fibrillation \n\n Severe heart valve disease \n\n Anticoagulation therapy \n\n Pregnancy", - "brief_summary": "Introduction: Patients with atrial fibrillation (AF) have a substantial risk of stroke and systemic embolism. Subclinical AF is often suspected to be the cause of stroke in these patients. The detection of asymptomatic AF episodes is a challenge and the real rate of occurrence of these episodes remains unknown. The rate of stroke is high among patients who have received a pacemaker and this device can detect subclinical episodes of rapid atrial rate, which correlate with electrocardiographically documented AF. The net benefit of anticoagulant treatment is well established in patients with clinical AF but data about anticoagulation in subclinical AF setting is unknown. The aim of this study is to assess the impact of anticoagulant therapy on subclinical AF, directed by cardiac implantable electronic device (CIED) intensive monitoring, on the incidence of stroke and systemic embolism and correlate the AF episodes detected by CIED with thromboembolic events. Methods: This is a prospective, randomized, unicentric, parallel clinical study in patients with atrioventricular pacemaker, defibrillator, or cardiac resynchronization therapy devices in sinus rhythm and CHADS2 score (an index of the risk of stroke in patients with atrial fibrillation, range from 0 to 6) \u2265 2 . Patients will be randomized to the intervention group - intensive monitoring arm (Group I) or control group - routine schedule arm (Group II) in a 1:1 ratio. Time to inclusion will be 24 months and all patients will be followed up for a period of 36 months. Group I, patients will be submitted to device data collection every 2 months, while in Group II, patients will be managed conventionally. Patients from Group I with episodes of subclinical AF will receive anticoagulant therapy, as well as patients with clinical AF of both arms. Device data from Group II patients will not be analyzed until they achieve the primary endpoint. Primary endpoint: stroke or systemic embolism. Secondary endpoints: subclinical AF rate, total mortality, cardiovascular mortality, myocardial infarction, cardiovascular hospitalization, and bleeding rates. Expected outcome: It is expected that anticoagulation therapy of subclinical AF directed by CIED intensive monitoring will reduce the incidence of stroke and systemic embolism comparing to patients with non-diagnosed subclinical AF.", - "NCTID": "NCT02004509" - }, - { - "brief_title": "Potential Risk Factors for Stroke", - "phase": "Phase 1", - "drugs": "['cytokine and leukocyte activation profile']", - "drugs_list": [ - "cytokine and leukocyte activation profile" - ], - "diseases": "['Carotid Atherosclerosis', 'Cerebrovascular Accident', 'Diabetes Mellitus', 'Hypercholesterolemia', 'Hypertension']", - "diseases_list": [ - "Carotid Atherosclerosis", - "Cerebrovascular Accident", - "Diabetes Mellitus", - "Hypercholesterolemia", - "Hypertension" - ], - "enrollment": "500.0", - "inclusion_criteria": "Male or female greater than 18 years of age. \n\n Patient must have documented hypertension (diastolic BP greater than 90 mmHg or systolic BP greater than 140 mmHg) for greater than 1 year OR hypercholesterolemia (LDL greater than 160 or total Chol greater than 240 with a total cholesterol/HDL-Chol ratio more than 1.6 for greater that 1 year OR Diabetes (blood glucose greater than 150 mg/dl requiring oral antihyperglycemics or insulin dependent) for greater than 1 year OR any combination. \n\n Subgroup eligibility for risk factors with cerebral ischemic events must meet criteria #2 plus documented stroke by physical exam and CT and/or MRI consistent with ischemic infarction or TIA witnessed and recorded by medical personnel. \n\n Patient will be excluded if enrollment time is within 30 days of a stroke, myocardial infarction, or surgery. Patient may be enrolled after 30 days of the above events. \n\n No patients on immunosuppressive therapy. \n\n No patients who are unable to follow up for 1 year from the time of enrollment. \n\n No stroke patients with an identifiable cardiac source (including atrial fibrillation, mural thrombus, valvular disease with vegetation).", - "exclusion_criteria": "", - "brief_summary": "Early studies have shown that the immune system may play a role in the development of strokes. Conditions such as high blood pressure, high cholesterol, diabetes, and old age can activate the immune system and increase the risk of developing hardening of the arteries (atherosclerosis) and damaged blood vessels.~Researchers will attempt to characterize factors that may contribute to atherosclerosis and stroke by measuring certain components of the immune system, cytokines and leukocyte activation. Measurements will be taken from patients that are considered to be stroke prone and from patients without risk factors for the development of stroke. Researchers will measure the immune system components at the beginning of the study, at six months, and at the one-year completion of the study.~The study will attempt to determine;~I) If patients with risk factors for stroke have an increased activation of the immune system~II) If patients with risk factors for stroke that are symptomatic have higher levels of immune system activation compared to patients who do not have symptoms~III) If patients with increased activation of the immune system have accelerated hardening of the arteries (atherosclerosis)", - "NCTID": "NCT00001368" - }, - { - "brief_title": "Identification the Cause of Cerebral Infarction in Patients With Cancer", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cryptogenic Embolic Stroke', 'Active Cancer']", - "diseases_list": [ - "Cryptogenic Embolic Stroke", - "Active Cancer" - ], - "enrollment": "118.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects with acute ischemic stroke who presented within 7 days from symptom onset \n\n Subjects who had embolic infarction outside the perforator territory revealed by diffusion-weighted imaging \n\n Subjects with undetermined cause of stroke despite of initial evaluation including electrocardiogram and brain imaging upon admission \n\n Subjects who performed brain magnetic resonance image (MRI) and MR angiography (MRA), cardiac work-ups (12-lead electrocardiography, transthoracic and/or transesophageal echocardiography with injection of agitated saline (or agitated saline transcranial Doppler monitoring), and 24-hour Holter and/or telemonitoring) \n\n Subjects with informed consent \n\n ", - "exclusion_criteria": ": \n\n Subjects with single subcortical infarction \n\n Subjects with primary brain tumor \n\n Inability to perform comprehensive studies \n\n Refusal or withdrawal of the consent", - "brief_summary": "Although there has been increasing interest in the association between cancer and cerebrovascular disease, the underlying pathophysiology of stroke in cancer patients is still not fully understood. The aim of this study is to investigate the stroke mechanisms in patients with cancer-associated stroke.", - "NCTID": "NCT02212496" - }, - { - "brief_title": "A Cross-sectional Study for the Determination of the Prevalence of Non-valvular Atrial Fibrillation Among Patients Diagnosed With Hypertension", - "phase": "", - "drugs": "['Standard of care']", - "drugs_list": [ - "Standard of care" - ], - "diseases": "['Hypertension', 'Atrial Fibrillation']", - "diseases_list": [ - "Hypertension", - "Atrial Fibrillation" - ], - "enrollment": "1119.0", - "inclusion_criteria": "inclusion criteria: \n\n Female and male outpatients aged 60 years and older \n\n Patients having being diagnosed with arterial hypertension \n\n For patients without a history of AF diagnosis, the decision to perform electrocardiography testing, either standard 12-lead ECG or ambulatory ECG, at the study visit has been made as per the investigator's routine practice \n\n Patients with available medical records \n\n Written signed and dated informed consent \n\n ", - "exclusion_criteria": " \n\n Presence of any condition/circumstance which in the opinion of the investigator would make the patient unfit to participate in the study or would compromise the quality of the study data (e.g., non-native speaker or patient who does not understand the local language unless reliable interpreter services are available; failure to cooperate due to major psychiatric disturbances, dementia, or substance use disorder) \n\n Patients currently participating in any investigational program with interventions outside of routine clinical practice or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to enrollment", - "brief_summary": "Arterial hypertension has been recognized as a major causal factor for atrial fibrillation (AF), the most common sustained cardiac arrhythmia. In light of its worldwide increasing prevalence and incidence and the accompanied increase in the risk of stroke, thromboembolic events and mortality, AF has emerged as a global healthcare problem.~Early diagnosis of AF, prior to the occurrence of complications is a recognized priority for the prevention of strokes. Once diagnosed, anticoagulant therapy is the cornerstone in the management of the risk of stroke in AF patients. The 2012 ESC Guidelines recommend the use of a risk factor-based approach to stroke risk stratification for AF patients.~This study aims towards gaining real-world data on the prevalence of non-valvular atrial fibrillation (NVAF) among hypertensives in Greece. The rate of ESC guideline-adherent antithrombotic therapy on the basis of stroke and bleeding risk assessments, and factors influencing treatment decision-making will be assessed as well in patients diagnosed with the arrhythmia.~Finally, potential differences in the NVAF prevalence in adequately and inadequately controlled hypertensives will be documented.", - "NCTID": "NCT02585076" - }, - { - "brief_title": "The Mobile Diabetes Mgmt. Study With Type 2 Diabetes", - "phase": "", - "drugs": "['Traditional care with paper', 'Health-on G App. + Physician Web']", - "drugs_list": [ - "Traditional care with paper", - "Health-on G App. + Physician Web" - ], - "diseases": "['Type 2 Diabetes']", - "diseases_list": [ - "Type 2 Diabetes" - ], - "enrollment": "184.0", - "inclusion_criteria": "inclusion criteria: \n\n 20-80 years of age \n\n Type 2 diabetes patients (who have taken stably oral diabetic drugs or insulin, and been doing lifestyle improvement by doctor's advice for recent over 3 months) \n\n in case insulin treated, patients with basal insulin once a day or premixed insulin twice a day \n\n HbA1c between 7.0% and 10.0% \n\n ability to understand and use smartphone application \n\n ", - "exclusion_criteria": ": \n\n type 1 diabetes or patients using insulin pump \n\n severe complications (stage IV,V chronic kidney failure, diabetic food complications, unstable angina pectoris, MI or stroke, surgical procedure of coronary & peripheral artery within recent 6 months) \n\n uncontrolled hypertension \n\n pregnant woman, fertile woman who will not use contraception \n\n unable to use application during treatment \n\n taking medication which can affect on glucose level \n\n alcohol abuse or dependency \n\n over 2.5 times from the upper limit of liver enzyme level \n\n DKA(diabetic ketoacidosis) or HHS(Hyperglycemic hyperosmolar syndrome) history during recent 6 months", - "brief_summary": "A Multi-center, Randomized, Parallel, Open Clinical Trial to Evaluate the Glycemic Control Effect of the Mobile Healthcare Service Using U-Healthcare Clinical Decision Support System (CDSS) and U-Healthcare Gateway in Patients with Type 2 Diabetes Mellitus", - "NCTID": "NCT02451631" - }, - { - "brief_title": "PREVAIL: PREvention of VTE After Acute Ischemic Stroke With LMWH Enoxaparin ( - VTE: Venous Thromboembolism - LMWH: Low Molecular Weight Heparin)", - "phase": "Phase 4", - "drugs": "['Enoxaparin sodium']", - "drugs_list": [ - "Enoxaparin sodium" - ], - "diseases": "['Acute Ischemic Stroke']", - "diseases_list": [ - "Acute Ischemic Stroke" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Acute ischemic stroke, any territory, with an appropriate neuroradiologic study (head CT scan or brain MRI scan) providing results consistent with non hemorrhagic stroke \n\n Onset of symptoms of qualifying stroke within 48 hours prior to randomization. In patients receiving thrombolytic therapy for the acute stroke, such as tissue-type plasminogen activator (tPA), administration of study drug may not start until at least 24 hours after completion of thrombolytic therapy \n\n Significant motor impairment of the leg, as indicated by a NIHSS score \u22652 on item 6 \n\n Inability to walk without assistance \n\n ", - "exclusion_criteria": ": \n\n Females who are pregnant, breast-feeding, or of childbearing potential and not using medically acceptable and effective contraception \n\n Clinical evidence of VTE at screening \n\n Any evidence of active bleeding on the basis of clinical judgment \n\n Prior history of intracranial hemorrhage (including that at screening) \n\n Spinal or epidural analgesia or lumbar puncture within the preceding 24 hours \n\n Thrombolytic therapy (e.g., tPA) or intra-arterial thrombolytic therapy within the preceding 24 hours.Thrombolytic therapy is permitted for treatment of the acute stroke but must have been completed 24 hours prior to randomization. \n\n Comatose at screening (NIHSS score \u22652 on item 1a) \n\n Known or suspected cerebral aneurysm or arteriovenous malformation \n\n Confirmed malignancy that may pose an increased risk for bleeding or otherwise compromise follow-up or outcome assessment (e.g., lung cancer) \n\n Impaired hemostasis, i.e., known or suspected coagulopathy (acquired or inherited); baseline platelet count <100,000/mm3; aPTT 1.5 X the laboratory upper limit of normal; or international normalized ratio(INR) >1.5 \n\n Major surgery or recent major trauma within the previous 3 months \n\n Anticipated need for full-dose treatment with therapeutic levels of an anticoagulant (LMWH, UFH, oral anticoagulant), e.g., for cardiogenic source of embolism or dissection \n\n Treatment with a LMWH or UFH at prophylactic dose for more than 48 hours prior to randomization(patients receiving LMWH or UFH less than 48 hours prior to randomization may be randomized) \n\n Allergy to heparin or enoxaparin sodium, or known hypersensitivity to heparin, enoxaparin, or pork products \n\n History of heparin or enoxaparin induced thrombocytopenia and/or thrombosis (heparin-induced thrombocytopenia [HIT], heparin-associated thrombocytopenia [HAT], or heparin-induced thrombotic thrombocytopenia syndrome [HITTS]) \n\n History of hypersensitivity to iodinated contrast media and/or iodine \n\n Bacterial endocarditis \n\n Prosthetic heart valve \n\n Known or suspected severe anemia (Hg <10.0 g/dL) \n\n Uncontrolled arterial hypertension (systolic blood pressure [BP] >180 mmHg or diastolic BP >100 mmHg) at the time of randomization or clinical hypertensive urgency \n\n Any other clinically relevant serious diseases, including severe liver disease or renal failure [creatinine clearance <30 mL/min on at least two occasions]. \n\n Treatment with other investigational agents or devices within the previous 30 days, planned use of other investigational drugs or devices, or previous enrollment in this study.", - "brief_summary": "Primary objective:~To demonstrate superiority of enoxaparin 40 mg sc qd in the prevention of VTE compared to UFH (unfractionated heparin) 5000 U sc q12 hours given for 10 \u00b1 4 days following acute ischemic stroke.~Secondary objectives:~To compare the incidence of VTE between the 2 treatment groups at 30, 60, and 90 days from the time of randomization~To compare neurologic outcomes between the 2 treatment groups, including incidence of stroke recurrence, rate of stroke progression, and patient functional status, during the 10 \u00b1 4 days of treatment, and after 30, 60, and 90 days from the time of randomization~To evaluate the safety of using enoxaparin compared to UFH for VTE prevention in patients following acute ischemic stroke", - "NCTID": "NCT00077805" - }, - { - "brief_title": "Safe Implementation of Thrombolysis in Stroke - Monitoring Study", - "phase": "", - "drugs": "['alteplase']", - "drugs_list": [ - "alteplase" - ], - "diseases": "['Stroke']", - "diseases_list": [ - "Stroke" - ], - "enrollment": "6475.0", - "inclusion_criteria": "inclusion criteria: \n\n Female or male in-patient \n\n Age 18 - 80 years \n\n Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition, gaze, vision and/or neglect. Ischemic stroke is defined as an event characterized by sudden onset of acute focal neurological deficit, presumed to be caused by cerebral ischemia, after CT scan exclusion of hemorrhage \n\n Onset of symptoms within 3 hours prior to initiation of thrombolysis treatment \n\n Stroke symptoms present for at least 30 minutes that had not significantly improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure, or migraine disorder \n\n Patients are willing to receive thrombolysis treatment and to give informed consent with regard to retrieval of data and follow up procedures, according to the regulations in participating countries \n\n Willingness and ability to comply with the study protocol \n\n ", - "exclusion_criteria": ": \n\n Evidence of intracranial hemorrhage (ICH) on the CT-scan \n\n Symptoms of ischemic attack began more than 3 hours prior to infusion start or when time of symptom onset is unknown \n\n Minor neurological deficit or symptoms rapidly improving before start of infusion \n\n Severe stroke as assessed clinically and/or by appropriate imaging techniques \n\n Seizure at onset of stroke \n\n Symptoms suggestive of subarachnoid hemorrhage, even if the CT-scan is normal \n\n Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory \n\n Patients with any history of prior stroke and concomitant diabetes \n\n Prior stroke within the last 3 months \n\n Platelet count of below 100,000/mm\u00b3 \n\n Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, or aggressive management (IV medication) necessary to reduce BP to these limits \n\n Blood glucose <50 or > 400 mg/dl \n\n Known hemorrhagic diathesis \n\n Patients receiving oral anticoagulants, e.g. warfarin sodium \n\n Manifest or recent severe or dangerous bleeding \n\n Known history of or suspected intracranial hemorrhage \n\n Suspected subarachnoid hemorrhage or condition after subarachnoid hemorrhage from aneurysm \n\n Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) \n\n Hemorrhagic retinopathy, e.g. in diabetes (vision disturbances may indicate hemorrhagic retinopathy) \n\n Recent (less than 10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture \n\n Bacterial endocarditis, pericarditis \n\n Acute pancreatitis \n\n Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial- aneurysm, arterial/venous malformation \n\n Neoplasm with increased bleeding risk \n\n Severe liver disease, including hepatic failure, cirrhosis, portal hypertension oesophageal varices) and active hepatitis \n\n Major surgery or significant trauma in past 3 months \n\n All in- and ", - "brief_summary": "Study to evaluate the safety and efficacy of intravenous alteplase within 3 hours of symptom onset in acute ischemic stroke patients", - "NCTID": "NCT02229812" - }, - { - "brief_title": "Tailored Treatment of Permanent Atrial Fibrillation", - "phase": "Phase 3", - "drugs": "['Medtronic Cardiac Ablation System', 'Class I or III Antiarrhythmic Medications']", - "drugs_list": [ - "Medtronic Cardiac Ablation System", - "Class I or III Antiarrhythmic Medications" - ], - "diseases": "['Atrial Fibrillation']", - "diseases_list": [ - "Atrial Fibrillation" - ], - "enrollment": "210.0", - "inclusion_criteria": "inclusion criteria: \n\n History of symptomatic, continuous atrial fibrillation defined as: Continuous atrial fibrillation lasting greater than 1 year but less than 4 years or nonself-terminating atrial fibrillation, lasting greater than 7 days but no more than 1 year, with at least one failed direct current cardioversion. A failed cardioversion was defined as an unsuccessful cardioversion or one in which normal sinus rhythm was established but not maintained beyond 7 days. \n\n Atrial fibrillation symptoms included the following: palpitations, fatigue,exertional dyspnea, exercise intolerance \n\n Age between 18 and 70 years \n\n Failure of at least one Class I or III rhythm control drug \n\n Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study. \n\n ", - "exclusion_criteria": ": \n\n Structural heart disease of clinical significance including: \n\n Previous cardiac surgery (excluding coronary artery bypass graft and mitral valve repair) \n\n Symptoms of congestive heart failure including, but not limited to, New York Heart Association (NYHA) Class III or IV congestive heart failure and/or documented ejection fraction <40% measured by acceptable cardiac testing \n\n Left atrial diameter >55 mm \n\n Moderate to severe mitral or aortic valvular heart disease \n\n Stable/unstable angina or ongoing myocardial ischemia \n\n Myocardial infarction (MI) within 3 months of enrollment \n\n Congenital heart disease (not including atrial septal defect or patent foramen ovale without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure \n\n Prior atrial septal defect of patent foramen ovale closure with a device using a percutaneous approach \n\n Hypertrophic cardiomyopathy (left ventricular septal wall thickness >1.5 cm) \n\n Pulmonary hypertension (mean or systolic pulmonary artery pressure >50 mm Hg on Doppler echo) \n\n Any prior ablation for atrial fibrillation \n\n Enrollment in any other ongoing arrhythmia study \n\n Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the management may interfere with this study \n\n Active infection or sepsis \n\n Any history of cerebral vascular disease including stroke or transient ischemic attacks \n\n Pregnancy or lactation \n\n Left atrial thrombus at the time of ablation \n\n Untreatable allergy to contrast media \n\n Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes \n\n History of blood clotting (bleeding or thrombotic) abnormalities \n\n Known sensitivities to heparin or warfarin \n\n Severe chronic obstructive pulmonary disease (defined as forced expiratory volume 1 (FEV1) <1) \n\n Severe co-morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate", - "brief_summary": "The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac Ablation System compared to medical therapy in the persistent and long-standing persistent atrial fibrillation population.", - "NCTID": "NCT00514735" - }, - { - "brief_title": "A Blood Pressure Regulation and Stroke Risk Evaluation Study in Hypertensive Patients Treated With Eprosartan", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Stroke', 'Hypertension']", - "diseases_list": [ - "Stroke", - "Hypertension" - ], - "enrollment": "533.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult patients (age greater or equal to 18 years) \n\n Hypertensive patients, with a sitting Systolic Blood Pressure above 140 mmHg or 130 mmHg in diabetics and high/very high risk patients, according to ESC/ESH Guidelines \n\n Patients being prescribed eprosartan under the terms and conditions of the local label and administered according to standard medical practice \n\n Patients with at least one of the following conditions: \n\n Newly diagnosed hypertension, \n\n Inability to tolerate other antihypertensive medications, or \n\n Lack of response to current antihypertensive medication(s) \n\n ", - "exclusion_criteria": ": \n\n 1. Any contraindication to eprosartan or the excipients (according to the local label)", - "brief_summary": "The primary objective of the study is to evaluate the proportion of hypertensive patients who achieve regulation of their blood pressure (BP) levels according to the European Society of Cardiology / European School of Haematology (ESC/ESH) Guidelines, after treatment with eprosartan for 6 months under standard medical practice conditions. The absolute change in Systolic blood pressure from baseline will also be calculated.~This study also aims in the evaluation of Framingham stroke risk profile score of patients treated with eprosartan under standard clinical practice conditions during the observation period. Besides the primary and the secondary objective of the study, the assessment of the percentage of patients who experienced Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs) (overall and per observed event) and the percentage of patients who discontinued treatment prematurely before the advent of the 6-month observation period due to toxicity to the study medication constitutes another important objective that is related to the safety of the treatment.", - "NCTID": "NCT01562613" - }, - { - "brief_title": "Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus", - "phase": "Phase 4", - "drugs": "['amlodipine/benazepril']", - "drugs_list": [ - "amlodipine/benazepril" - ], - "diseases": "['Albuminuria']", - "diseases_list": [ - "Albuminuria" - ], - "enrollment": "332.0", - "inclusion_criteria": "inclusion criteria: \n\n Mild to moderate hypertension \n\n Type 2 diabetes mellitus \n\n Presence of protein in the urine (albuminuria) \n\n ", - "exclusion_criteria": ": \n\n Kidney disease not caused by diabetes or hypertension \n\n Renal artery stenosis \n\n Myocardial infarction or stroke within the last 6 months \n\n Type 1 diabetes mellitus \n\n Pregnant or lactating females \n\n Cancer within the last 5 years", - "brief_summary": "Type 2 diabetes mellitus is usually associated with high blood pressure, which is a risk factor for kidney disease. Aggressive blood pressure reduction is an important strategy to protect the kidney and reduce urinary protein which develops with kidney disease. This study will evaluate the effects of amlodipine/benazepril in reducing blood pressure and urinary protein in hypertensive subjects with type 2 diabetes mellitus.", - "NCTID": "NCT00136773" - }, - { - "brief_title": "Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)", - "phase": "Phase 3", - "drugs": "['amiodarone', 'sotalol', 'propafenone', 'flecainide', 'quinidine', 'moricizine', 'disopyramide', 'procainamide', 'adrenergic beta antagonists', 'verapamil', 'diltiazem', 'digoxin', 'catheter ablation', 'pacemaker, artificial']", - "drugs_list": [ - "amiodarone", - "sotalol", - "propafenone", - "flecainide", - "quinidine", - "moricizine", - "disopyramide", - "procainamide", - "adrenergic beta antagonists", - "verapamil", - "diltiazem", - "digoxin", - "catheter ablation", - "pacemaker", - "artificial" - ], - "diseases": "['Arrhythmia', 'Atrial Fibrillation', 'Cardiovascular Diseases', 'Heart Diseases']", - "diseases_list": [ - "Arrhythmia", - "Atrial Fibrillation", - "Cardiovascular Diseases", - "Heart Diseases" - ], - "enrollment": "", - "inclusion_criteria": "Elderly men and women with atrial fibrillation and other risk factors for stroke.", - "exclusion_criteria": "", - "brief_summary": "To compare two standard treatment strategies for atrial fibrillation: ventricular rate control and anticoagulation vs. rhythm control and anticoagulation.", - "NCTID": "NCT00000556" - }, - { - "brief_title": "An Observational Cross-sectional Study Evaluating the Use of Re-sources and the Sociodemographic and Clinical Characteristics of Patients Diagnosed With Non-valvular Atrial Fibrillation With a Risk of Stroke or Systemic Embolism on Anticoagulant Therapy and Treated in Primary Care Centers", - "phase": "", - "drugs": "['Direct Oral Anticoagulant (DOAC)']", - "drugs_list": [ - "Direct Oral Anticoagulant (DOAC)" - ], - "diseases": "['Stroke', 'Prevention and Control', 'Atrial Fibrillation']", - "diseases_list": [ - "Stroke", - "Prevention and Control", - "Atrial Fibrillation" - ], - "enrollment": "247.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients \u226518 years of age diagnosed with non-valvular atrial fibrillation with a risk of stroke or systemic embolism treated in primary care centres. \n\n Patients on regular treatment with anticoagulants who have changed their therapeutic regimen due to any clinical situation and have been on treatment with a direct oral anticoagulant for at least three months before being recruited (date of signing the in-formed consent). \n\n Patients whose first direct oral anticoagulant prescription is written by the specialist (cardiologist, haematologist, internist, etc.) and who are followed in primary care. \n\n Patients who have given their informed consent in writing. \n\n ", - "exclusion_criteria": ": \n\n Patients who changed their anticoagulant therapy within a period of less than three months before signing the informed consent. \n\n Patients with cognitive impairment preventing them from understanding what is written in the patient information sheet or the informed consent, or from per-forming the self-administered questionnaires. \n\n Patients who started anticoagulant therapy for non-valvular atrial fibrillation with a direct oral anticoagulant .", - "brief_summary": "This is a retrospective observational study to describe the sociodemographic and clinical characteristics of patients diagnosed with non-valvular atrial fibrillation (NVAF) at risk of stroke or systemic embolism, who at least three months ago changed their anticoagulant therapy, due to any clinical situation, and are currently on treatment with a direct oral anticoagulant (DOAC)", - "NCTID": "NCT02559232" - }, - { - "brief_title": "Valsartan/Hydrochlorothiazide Combination vs Amlodipine in Patients With Hypertension, Diabetes, and Albuminuria.", - "phase": "Phase 4", - "drugs": "['valsartan/hydrochlorothiazide']", - "drugs_list": [ - "valsartan/hydrochlorothiazide" - ], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "144.0", - "inclusion_criteria": "inclusion criteria: \n\n type 2 diabetes \n\n elevated blood pressure and pulse pressure \n\n albuminuria \n\n ", - "exclusion_criteria": ": \n\n Severe hypertension \n\n History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm \n\n Liver, kidney (not caused by diabetes), or pancreas disease \n\n Type 1 diabetes or uncontrolled type 2 diabetes \n\n Allergy to certain medications used to treat high blood pressure \n\n Other protocol-defined inclusion/", - "brief_summary": "The purpose of this study is assess if treatment with valsartan and a diuretic, hydrochlorothiazide, has beneficial effects in people with high blood pressure, diabetes, and albuminuria (protein in the urine) compared with amlodipine. In particular, the study will assess whether the treatment will decrease the stiffness of the blood vessels.", - "NCTID": "NCT00171561" - }, - { - "brief_title": "Use of Loop Recorders for Diagnosis of Palpitations in A&E", - "phase": "", - "drugs": "['Implantable Loop Recorder']", - "drugs_list": [ - "Implantable Loop Recorder" - ], - "diseases": "['Palpitations']", - "diseases_list": [ - "Palpitations" - ], - "enrollment": "56.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 years or older \n\n Good history of episodic symptomatic sustained palpitations (sudden onset and offset, fast heart beats, may be associated with shortness of breath or dizziness) \n\n Terminates before presentation to hospital \n\n Episodes occur at a frequency of less than once every two weeks \n\n Never previously caught on ECG or ambulatory monitoring \n\n Normal resting ECG \n\n ", - "exclusion_criteria": ": \n\n Contraindication to ILR implantation i.e. ongoing oral anticoagulation with INR >1.6, ongoing infection, sepsis or fever, etc. \n\n Palpitations suggestive of extrasystoles (single missed or dropped beats) \n\n Known or suspected severe valvular or myocardial heart disease \n\n An audible heart murmur \n\n Any abnormality on the surface ECG \n\n Thyrotoxicosis \n\n Patients who refuse an ILR when offered will not be included in either limb of the study", - "brief_summary": "Heart rhythm abnormalities underlie one of the common presenting complaints to the A&E and out-patient departments, specifically awareness of heart beats or palpitations. Unless an ECG (electrocardiogram) tracing of the heart rhythm can be recorded while the patient is having symptoms, it is very difficult to determine the cause of the palpitations. The conventional approach is to refer these patients from the emergency departments to the Cardiology outpatients where they undergo repeated short term rhythm monitoring hoping to record the rhythm underlying the patient's complaint. Unfortunately, this often yields no results thus delaying definitive treatment and incurring extra costs of repeated investigations and A&E presentations. This study aims to compare the ability of the conventional approach to establish a definite diagnosis compared to that of an early invasive monitoring approach with a small implantable device that records the heart rhythm at all time for up to 18 months.", - "NCTID": "NCT01170559" - }, - { - "brief_title": "Cardiovascular Health Study (CHS)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Heart Diseases', 'Cardiovascular Diseases', 'Coronary Disease', 'Cerebrovascular Accident', 'Diabetes Mellitus', 'Hypertension', 'Heart Failure, Congestive']", - "diseases_list": [ - "Heart Diseases", - "Cardiovascular Diseases", - "Coronary Disease", - "Cerebrovascular Accident", - "Diabetes Mellitus", - "Hypertension", - "Heart Failure", - "Congestive" - ], - "enrollment": "5888.0", - "inclusion_criteria": "Eligible participants were sampled from Medicare eligibility lists in each area. Those eligible included all persons living in the household of each individual sampled from the Health Care Financing Administration (HCFA) sampling frame, who were 65 years or older at the time of examination, were noninstitutionalized, were expected to remain in the area for the next three years, and were able to give informed consent and did not require a proxy respondent at baseline. Potentially eligible individuals who were wheelchair-bound in the home at baseline or were receiving hospice treatment, radiation therapy or chemotherapy for cancer were excluded.", - "exclusion_criteria": "", - "brief_summary": "To determine the extent to which known risk factors predict coronary heart disease and stroke in the elderly, to assess the precipitants of coronary heart disease and stroke in the elderly, and to identify the predictors of mortality and functional impairments in clinical coronary disease or stroke.", - "NCTID": "NCT00005133" - }, - { - "brief_title": "Sitagliptin in the Elderly", - "phase": "Phase 2", - "drugs": "['Sitagliptin 100 mg']", - "drugs_list": [ - "Sitagliptin 100 mg" - ], - "diseases": "['Type 2 Diabetes']", - "diseases_list": [ - "Type 2 Diabetes" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria: \n\n type 2 diabetes managed by diet or metformin only \n\n A1c < 8.5% \n\n ", - "exclusion_criteria": ": \n\n treated with insulin or oral agents other than metformin in the past 6 months \n\n evidence of diabetic complications including coronary artery disease, stroke, transient ischemic attacks, peripheral vascular disease, nephropathy, retinopathy, or neuropathy \n\n type 1 diabetes or a history suggestive of a secondary causes of diabetes \n\n A1c \u2265 8.5% \n\n participated in another clinical trial within the past 30 days", - "brief_summary": "Diabetes is common in the elderly; by the age of 70, approximately 25% of the population will have diabetes. Unfortunately, currently available medications are often not as effective or not well tolerated in older adults. Sitagliptin is a new medication in a new class of agent called incretins. Incretins have many potential advantages for the treatment of diabetes in the elderly. They stimulate insulin secretion, which is impaired in all older people with diabetes. The incidence of hypoglycemia with currently available medications increases with age, and incretins rarely cause hypoglycemia . They assist with weight loss, whereas many current medications used to manage diabetes result in weight gain in the elderly. They improve insulin action, and insulin resistance is a major problem in older people with diabetes.", - "NCTID": "NCT00451113" - }, - { - "brief_title": "Study of Aspirin and TPA in Acute Ischemic Stroke", - "phase": "Phase 1", - "drugs": "['Aspirin']", - "drugs_list": [ - "Aspirin" - ], - "diseases": "['Acute Ischemic Stroke']", - "diseases_list": [ - "Acute Ischemic Stroke" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients must meet all of the inclusion criteria. \n\n Diagnosis of acute ischemic stroke with onset less than 4.5 hours prior to the planned start of intravenous alteplase. Acute ischemic stroke is defined as a measurable neurological deficit of sudden onset, presumed secondary to focal cerebral ischemia. Stroke onset will be defined as the time the patient was last known to be without the new clinical deficit. Patients whose deficits have worsened in the last 4.5 hours are not eligible if their first symptoms started more than 4.5 hours before. If the stroke started during sleep, stroke onset will be recorded as the time the patient was last known to be at baseline. \n\n Disabling neurological deficit attributable to acute ischemic stroke in the middle cerebral artery territory. \n\n NIHSS less than or equal to 18 for left hemisphere strokes, NIHSS less than or equal to 16 for others. \n\n Evidence of MCA occlusion (stem or branch) prior to drug administration by TCD, CTA or MRA. \n\n Age 18-85 years, inclusive. \n\n Able to sign informed consent. \n\n For MRI Arm only: \n\n Screening MRI diagnostic of focal cerebral ischemia corresponding to the clinical deficits. The MRI evaluation must involve echo planar diffusion weighted imaging, MRA, and MRI perfusion. A normal appearing MRA with an appropriate perfusion deficit is eligible. An apparent stenosis or occlusion on MRA with normal appearing perfusion distally will not be eligible. Poor quality or uninterpretable MRA will not make patient ineligible. Patients who have a normal appearing DWI are eligible. \n\n Evidence on PWI MRI or a perfusion defect corresponding to the acute stroke syndrome. The PWI will be assessed by relative mean transit time (MTT) images obtained prior to the start of rt-TPA therapy. \n\n ", - "exclusion_criteria": ": \n\n Patients will be excluded from study participation for any of the following reasons: \n\n Current participation in another study with an investigational drug or device within, prior participation in the present study, or planned participation in another therapeutic trial, prior to the final (day 30) assessment in this trial. \n\n Absence of acoustic window to insonate the MCA on the involved side. \n\n Time interval since stroke onset of less than 3 hours is impossible to determine with high degree of confidence. \n\n Symptoms suggestive of subarachnoid hemorrhage, even if CT or MRI scan is negative for hemorrhage. \n\n Evidence of acute myocardial infarction defined as having at least two of the following three features: 1) Chest pain suggestive of cardiac ischemia; 2) EKG findings of ST elevation of more greater than 0.2 mV in 2 contiguous leads, new onset left bundle branch block, ST segment depression, or T-wave inversion; 3) Elevated troponin I. \n\n Acute Pericarditis. \n\n Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test. \n\n Neurological deficit that has led to stupor or coma (NIHSS level of consciousness [item I a] score greater than or equal to 2). \n\n High clinical suspicion of septic embolus. \n\n Minor stroke with non-disabling deficit or rapidly improving neurological symptoms. \n\n Baseline NIHSS greater than 18 for left hemisphere stroke or greater than 16 for others. \n\n Evidence of acute or chronic ICH by head CT or MRI. \n\n CT or MRI evidence of non-vascular cause for the neurological symptoms. \n\n Signs of mass effect causing shift of midline structures on CT or MRI. \n\n Persistent hypertension with systolic BP greater than 185 mmHg or diastolic BP greater than 110 mmHg (mean of 3 consecutive arm cuff readings over 20-30 minutes), not controlled by antihypertensive therapy or requiring nitroprusside for control. \n\n Anticipated need for major surgery within 72 hours after start of study drugs, e.g., carotid endarterectomy, hip fracture repair. \n\n Any intracranial surgery, intraspinal surgery, or serious head trauma (any head injury that required hospitalization) within the past 3 months. \n\n Stroke within the past 3 months. \n\n History of ICH at any time in the past. \n\n Major trauma at the time of stroke, e.g., hip fracture. \n\n Blood glucose greater than 200 mg/dl. \n\n Presence or history of intracranial neoplasm (except small meninigiomas) or arteriovenous malformation. \n\n Intracranial aneurysm, unless surgically or endovascularly treated more than 3 months before. \n\n Seizure at the onset of stroke. \n\n Active internal bleeding. \n\n Major hemorrhage (requiring transfusion, surgery or hospitalization) in the past 21 days. \n\n Major surgery, serious trauma, lumbar puncture, arterial puncture at a non-compressible site, or biopsy of a parenchymal organ in last 14 days. Major surgical procedures include but are not limited to the following: major thoracic or abdominopelvic surgery, neurosurgery, major limb surgery, carotid endarterectomy or other vascular surgery, and organ transplantation. For non-listed procedures, the operating surgeon should be consulted to assess the risk. \n\n Presumed or documented history of vasculitis. \n\n Known systemic bleeding or platelet disorder, e.g., von Willebrand's disease, hemophilia, ITP, TTP, others. \n\n Platelet counts less than 100,000 cells/micro L. \n\n Congenital or acquired coagulopathy (e.g., secondary to anticoagulants) causing either of the following: \n\n Activated partial thromboplastin time (aPTT) prolongation greater than 2 seconds above the upper limit of normal for local laboratory, except if due to isolated factor XII deficiency. \n\n INR greater than or equal to 1.4. Patients receiving warfarin prior to entry are eligible provided INR is less than 1.4 and warfarin can be safely discontinued for at least 48 hours. \n\n Life expectancy less than 3 months. \n\n Other serious illness, e.g., severe hepatic, cardiac, or renal failure; acute myocardial infarction; or complex disease that may confound treatment assessment. \n\n Severe renal failure: Serum creatinine greater than 4.0 mg/dL or dependency on renal dialysis. \n\n AST or ALT greater than 3 times the upper limit of normal for the local laboratory. \n\n Treatment of the qualifying stroke with any thrombolytic, anti-thrombotic or GPIIbIIIa inhibitor outside of this protocol. \n\n Any administration of a thrombolytic drug in the prior 7 days. \n\n Treatment of the qualifying stroke with intravenous heparin unless aPTT prolongation is no greater than 2 seconds above the upper limit of normal for local laboratory prior to study drug initiation. \n\n Treatment of the qualifying stroke with a low molecular weight heparin or heparinoid. \n\n Known hypersensitivity to TPA. \n\n Anticoagulation (evidenced by abnormal INR, aPTT, or platelet count) caused by herbal therapy. \n\n FOR non-MRI arm only (#42-43): \n\n Ischemic changes on screening CT of greater than approximately one third of the territory of the middle cerebral artery territory by qualitative assessment. \n\n Patients who were excluded by screening MRI, except for exclusions #45 (contraindication to MRI) and #46 (PWI was not obtained or is uninterpretable) and #50 (MRI not obtainable because it would have put the patient out of the 3 hour time window for alteplase). \n\n FOR MRI arm only (#44-51): \n\n Contraindication to MRI scan. \n\n PWI not obtained or uninterpretable. \n\n No MTT defect corresponding to acute stroke deficit. \n\n DWI abnormality larger than approximately one third of the territory of the middle cerebral artery territory by qualitative assessment. \n\n Satellite DWI hyperintensity with corresponding hyperintensity on T2 weighted image or FLAIR in a vascular territory different than the index stroke (this is evidence of a new ischemic lesion greater than 3 hours in duration). \n\n Evidence of multiple microbleeds on gradient echo MRI (GRE). \n\n MRI not obtained because it would have put the patient out of the 3 hour time window for alteplase.", - "brief_summary": "This study will determine the safety of 500mg of aspirin added to IV TPA at standard doses to prevent re-occlusion of cerebral vessels after successful reperfusion. In ischemic stroke brain arteries are occluded either by an embolus originating in the heart or large vessels leading to the brain or by a process of acute thrombosis of the cerebral arteries over a ruptured atherosclerotic plaque. Rupture of the plaque exposes thrombogenic elements within the plaque and leads to accumulation and activation of platelets and induction of the clotting cascade eventually leading to acute thrombosis and occlusion of the artery. TPA is currently approved by the Food and Drug Administration to treat heart and brain problems caused by blockage of arteries. It activates plasminogen and leads to disintegration of the thrombus/embolus. It is effective only if begun within 3 to 4.5 hours of onset of the stroke because of potential deleterious side effects including life threatening symptomatic intracranial hemorrhage (sICH) when the drug is administered outside of this time window.~Reperfusion of the ischemic brain (i.e. timely opening of the occluded artery) with TPA is associated with improved outcome. However, in about 33% of patients that have successfully reperfused after TPA the artery re-occludes within the first few hours resulting in worsening neurological symptoms and worse functional outcome. This re-occlusion is speculated to result from re-thrombosis over an existing ruptured atherosclerotic plaque. This is explained by the relatively short half life of TPA leaving the exposed ruptured plaque intact which leads to re-activation of platelets and clotting factors and re-thrombosis. Thus, we hypothesize that the addition of an antiplatelet agent to TPA would result in lower rates of re-occlusion after AIS. The FDA approved TPA for patients with AIS but discouraged the concomitant use of anti-platelet or anti-thrombotic drugs for the first 24hours after administration of TPA because of concerns that such therapy may result in increased rates of intracerebral hemorrhage. Aspirin is a well known platelet anti-aggregant that works by inhibition of cycloxygenase 1 and reduction in thromboxane A levels. It has a rapid onset of action and additional potential beneficial anti-inflammatory effects in patients with AIS. The international stroke study showed that acute treatment of stroke patients with 500mg of aspirin is safe and feasible and results in better outcome. Furthermore, the drug was safe in these circumstances with an ICH rate of only .~Therefore, the purpose of this clinical trial is to examine the safety and efficacy of the combination of aspirin with rt-TPA in patients with AIS.", - "NCTID": "NCT00417898" - }, - { - "brief_title": "The Effect of Implementing Hyper-acute Stroke Guidelines on Decision-Making for or Against Thrombolytic Therapy for Stroke in the Emergency Department", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Stroke']", - "diseases_list": [ - "Stroke" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Patients presenting to the emergency Signs and symptoms of acute ischemic stroke: impairment of language, motor function, cognition and/or gaze, vision or neglect. \n\n Patients with an NIH Stroke Scale score > 4 \n\n ", - "exclusion_criteria": ": \n\n Age less than 19 \n\n Patient symptomatic for greater than five hours. Intravenous thrombolytic therapy must be instituted within three hours of symptom onset in order to minimize the risk of Intracerebral or symptomatic hemorrhage; other interventions such as intra-arterial thrombolytic therapy and clot retrieval allow for a six-hour window. One hour is an achievable time for arrival to institution of therapy, therefore a five-hour limit on enrollment allows the greatest number of patients the possibility of therapy. \n\n Inability to verify a clear onset of symptoms. As noted, time elapsed since the patient's last known baseline state is correlated to Intracerebral and symptomatic hemorrhage, and therapy is approved only for patients with a clear time of onset.", - "brief_summary": "The objective of this study is to determine if the implementation of guidelines utilizing immediate CT Perfusion and CT Angiography in addition to non-contrast CT alters (reduces or increases) the time to decision-making for or against rt-PA in acute ischemic stroke, and by extension, time to therapy in treated patients and time to transfer from the department for all patients. A secondary objective is to determine if using CTP/CTA-inclusive hyperacute stroke guidelines improves safety by decreasing symptomatic intracerebral hemorrhage and mortality in patients who receive rt-PA.", - "NCTID": "NCT01050049" - }, - { - "brief_title": "Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography", - "phase": "Phase 3", - "drugs": "['Cardiac Computed Tomography']", - "drugs_list": [ - "Cardiac Computed Tomography" - ], - "diseases": "['Acute Coronary Syndrome', 'Myocardial Infarction', 'Unstable Angina Pectoris']", - "diseases_list": [ - "Acute Coronary Syndrome", - "Myocardial Infarction", - "Unstable Angina Pectoris" - ], - "enrollment": "1000.0", - "inclusion_criteria": "inclusion criteria: \n\n Participant had at least five minutes of chest pain or equivalent (chest tightness; pain radiating to left, right, or both arms or shoulders, back, neck, epigastrium, jaw/throat; or unexplained shortness of breath, syncope/presyncope, generalized weakness, nausea, or vomiting thought to be of cardiac origin) at rest or during exercise within 24 hours of ED presentation, warranting further risk stratification, as determined by an ED attending. \n\n 2 or more cardiac risk factors (diabetes, hypertension, hyperlipidemia, current smoker and family history of coronary artery disease). \n\n Able to provide a written informed consent. \n\n <75 years of age, but >40 years of age. \n\n Able to hold breath for at least 10 seconds. \n\n Sinus rhythm. \n\n ", - "exclusion_criteria": ": \n\n New diagnostic ischemic ECG changes (ST-segment elevation or depression > 1 mm or T-wave inversion > 4 mm) in more than two anatomically adjacent leads or left bundle branch block \n\n Documented or self-reported history of CAD (MI, percutaneous coronary interventions [PCIs], coronary artery bypass graft [CABG], known significant coronary stenosis [>50%]) \n\n Greater than 6 hours since presentation to ED. \n\n BMI >40 kg/m2 \n\n Impaired renal function as defined by serum creatinine >1.5 mg/dL* \n\n Elevated troponin-T (> 0.09 ng/ml) \n\n Hemodynamically or clinically unstable condition (BP systolic < 80 mm Hg, atrial or ventricular arrhythmias, persistent chest pain despite adequate therapy) \n\n Known allergy to iodinated contrast agent \n\n Currently symptomatic asthma \n\n Documented or self-reported cocaine use within the past 48 hours (acute) \n\n On Metformin therapy and unable or unwilling to discontinue for 48 hours after the CT scan \n\n Contraindication to beta blockers (taking daily antiasthmatic medication): This exclusion only applies to patients with a heart rate >65 bpm at sites using a non-dual source CT scanner \n\n Participant with no telephone or cell phone numbers or no address (preventing follow-up) \n\n Participant with positive pregnancy test. Women of childbearing potential, defined as <2 years of menopause in the absence of hysterectomy or tube ligation, must have a pregnancy test performed within 24 hours before the CT scan. \n\n Participant unwilling to provide a written informed consent.", - "brief_summary": "The growing availability of cardiac computed tomography (CT)* in emergency departments (EDs) across the U.S. expands the opportunities for its clinical application, but also heightens the need to define its appropriate use in the evaluation of patients with acute chest pain. To address this need, we performed a randomized diagnostic trial (RDT) to determine whether integrating cardiac CT, along with the information it provides on coronary artery disease (CAD) and left ventricular (LV) function, can improve the efficiency of the management of these patients (i.e. shorten length of hospital stay, increase direct discharge rates from the ED, decreasing healthcare costs and improving cost effectiveness while being safe).", - "NCTID": "NCT01084239" - }, - { - "brief_title": "Honolulu Heart Program", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cardiovascular Diseases', 'Coronary Disease', 'Cerebrovascular Accident', 'Heart Diseases', 'Heart Failure, Congestive', 'Myocardial Infarction', 'Asthma', 'Emphysema', 'Lung Diseases, Obstructive', 'Aortic Aneurysm, Abdominal', 'Bronchitis', 'Dementia', 'Hypertension', 'Chronic Obstructive Pulmonary Disease', 'Heart Failure']", - "diseases_list": [ - "Cardiovascular Diseases", - "Coronary Disease", - "Cerebrovascular Accident", - "Heart Diseases", - "Heart Failure", - "Congestive", - "Myocardial Infarction", - "Asthma", - "Emphysema", - "Lung Diseases", - "Obstructive", - "Aortic Aneurysm", - "Abdominal", - "Bronchitis", - "Dementia", - "Hypertension", - "Chronic Obstructive Pulmonary Disease", - "Heart Failure" - ], - "enrollment": "", - "inclusion_criteria": "No eligibility criteria", - "exclusion_criteria": "", - "brief_summary": "To investigate coronary heart disease and stroke among American men of Japanese ancestry who were living on the island of Oahu in 1965. Morbidity and mortality surveillance of the original cohort is continuing.", - "NCTID": "NCT00005123" - }, - { - "brief_title": "Valsartan in Elderly Isolated Systolic Hypertension Study", - "phase": "Phase 4", - "drugs": "['target blood pressure']", - "drugs_list": [ - "target blood pressure" - ], - "diseases": "['Aged', 'Systolic Hypertension']", - "diseases_list": [ - "Aged", - "Systolic Hypertension" - ], - "enrollment": "3079.0", - "inclusion_criteria": "inclusion criteria: \n\n Outpatients aged over 70 years and less than 85 years, regardless of sex. \n\n Patients with stable seated systolic blood pressure of over 160 mmHg and diastolic blood pressure of less than 90 mmHg at two visits within 2 to 4 weeks. \n\n Previously untreated patients or patients who are on other therapy that can be converted to valsartan. \n\n ", - "exclusion_criteria": ": \n\n Patients with secondary hypertension or malignant hypertension. \n\n Patients with seated systolic blood pressure of over 200 mmHg. \n\n Patients with seated diastolic blood pressure of over 90 mmHg. \n\n Patients with a history of cerebrovascular disorder or myocardial infarction within 6 months prior to enrolment in the study. \n\n Patients who underwent coronary arterioplasty within 6 months prior to enrolment in the study or patients who will undergo coronary arterioplasty within 6 months after entry. \n\n Patients with severe heart failure (NYHA functional classification III and IV). \n\n Patients with severe aortic stenosis or valvular disease. \n\n Patients with atrial fibrillation, atrial flutter, or serious arrhythmia. \n\n Patients with renal dysfunction with serum creatinine level of over 2 mg/dL. \n\n Patients with serious liver dysfunction. \n\n Patients with a history of hypersensitivity to valsartan. \n\n Other patients who are judged to be inappropriate for the study by the investigator or sub-investigator.", - "brief_summary": "The aim of this study is to compare the incidence of cardiovascular events between two target systolic blood pressure levels, below 140 mmHg and below 150 mmHg under treatment with valsartan in elderly isolated systolic hypertensive patients in Japan.", - "NCTID": "NCT00151229" - }, - { - "brief_title": "Epidemiology of Carotid Disease in Elderly Adults", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cardiovascular Diseases', 'Heart Diseases', 'Hypertension', 'Carotid Artery Diseases', 'Atherosclerosis']", - "diseases_list": [ - "Cardiovascular Diseases", - "Heart Diseases", - "Hypertension", - "Carotid Artery Diseases", - "Atherosclerosis" - ], - "enrollment": "", - "inclusion_criteria": "No eligibility criteria", - "exclusion_criteria": "", - "brief_summary": "To determine whether a population with isolated systolic hypertension (ISH) had a higher prevalence of carotid disease than a normotensive population matched for age and sex, and to determine specific risk factors for carotid disease.", - "NCTID": "NCT00005230" - }, - { - "brief_title": "The Effects of Blood Pressure Reduction on Cerebral Perfusion and Cognition in the Elderly Population", - "phase": "Phase 4", - "drugs": "['anti-hypertensive medication']", - "drugs_list": [ - "anti-hypertensive medication" - ], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Age >= 70 years \n\n Systolic office blood pressure >= 160 mmHg \n\n Systolic home blood pressure >= 155 mmHg \n\n ", - "exclusion_criteria": ": \n\n Diabetes Mellitus \n\n Atrial fibrillation \n\n Dementia \n\n Renal failure requiring dialysis \n\n Life expectancy of less than 1 year \n\n Disabling stroke \n\n Contraindication for MRI or anti-hypertensive medication \n\n Systolic blood pressure > 220 mmHg", - "brief_summary": "The purpose of this study is to determine if a reduction in systolic blood pressure induced by anti-hypertensive medication results in changes in cerebral perfusion and cognition in hypertensive elderly. Hypertensive elderly will be treated using open-label anti-hypertensive medication for 8-12 weeks. Changes in cerebral perfusion and cognition will be assessed before and after treatment.", - "NCTID": "NCT00966199" - }, - { - "brief_title": "Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese(MEGA Study)", - "phase": "Phase 4", - "drugs": "['Diet', 'Diet+pravastatin']", - "drugs_list": [ - "Diet", - "Diet+pravastatin" - ], - "diseases": "['Hyperlipidemia']", - "diseases_list": [ - "Hyperlipidemia" - ], - "enrollment": "8000.0", - "inclusion_criteria": "inclusion criteria: \n\n TC:220\uff5e270mg/dl \n\n Male: 40-70 years old/ female: postmenopausal-70 years old \n\n <40kg in weight \n\n ", - "exclusion_criteria": ": \n\n FH \n\n History of CHD(angina, MI, post-PTCA/CABG, etc.) \n\n History of CVA(stroke, TIA, etc.) \n\n Underlying malignant tumor", - "brief_summary": "To evaluate the primary preventive effect of low-dose pravastatin against coronary heart disease (CHD) in Japanese hypercholesterolemic patients.", - "NCTID": "NCT00211705" - }, - { - "brief_title": "The Hypertension in the Very Elderly Trial (HYVET)", - "phase": "Phase 4", - "drugs": "['Indapamide SR 1.5mg; Perindopril 2-4mg']", - "drugs_list": [ - "Indapamide SR 1.5mg; Perindopril 2-4mg" - ], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "4000.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged 80 or older \n\n Sitting systolic BP 160-199 mmHg AND sitting diastolic BP < 110 mmHg \n\n ", - "exclusion_criteria": ": \n\n Known accelerated hypertension (retinal haemorrhages or exudates or papilloedema). \n\n Overt clinical congestive heart failure requiring treatment with a diuretic or angiotensin converting enzyme inhibitor. Subjects allowed if treated with digoxin only. \n\n Renal failure (serum creatinine of more than 150 \u00b5mol/l). \n\n Previous documented cerebral or subarachnoid haemorrhage in the last 6 months. (Ischaemic cerebral and cardiac events do not exclude, although the patient must be neurologically and cardiologically stable.) \n\n Condition expected to severely limit survival, e.g. terminal illness. \n\n Known secondary hypertension (e.g. renal artery stenosis, chronic renal insufficiency, and endocrine cause). \n\n Gout. \n\n Clinical diagnosis of dementia. \n\n Resident in a nursing home, i.e. where the dependency and care requirements of the patients are such that they require the regular input of qualified nurses and therefore the majority of staff in the home are nurses (other forms of residential care are acceptable). \n\n Unable to stand up or walk \n\n Participation in a drug trial within the past month preceding selection. \n\n Alcohol or drug abuse. \n\n Less than 2 months placebo run-in. \n\n Contraindications to use of trial drugs", - "brief_summary": "The purpose of this study is to assess the benefits and risks of treating very elderly (those aged 80 or older) individuals with hypertension.", - "NCTID": "NCT00122811" - }, - { - "brief_title": "Burden of Illness in Atrial Fibrillation", - "phase": "", - "drugs": "['Standard of care in AF in Denmark']", - "drugs_list": [ - "Standard of care in AF in Denmark" - ], - "diseases": "['Atrial Fibrillation']", - "diseases_list": [ - "Atrial Fibrillation" - ], - "enrollment": "107532.0", - "inclusion_criteria": "inclusion criteria: \n\n Primary and secondary diagnosis with AF; \n\n The base population of AF patients will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code (ICD10-code: DI480, DI481, DI482, DI483, DI484, DI489) will be included. \n\n ", - "exclusion_criteria": ": \n\n Patients younger than 18 and older than 90 years of age.", - "brief_summary": "The overall goal of this retrospective registry study is to investigate the burden-of.illness in atrial fibrillation (AF) in Denmark. Several Danish registries will be utilized to collect information on the diseases epidemiology including incidence and prevalence of AF and stroke as well as a stroke risk stratification of the Danish AF-population, the clinical and economical burden (in terms of direct and indirect cost) of AF and stroke to Danish patients, healthcare providers / healthcare system and society as well as describing treatment patterns with anticoagulant agents and their consequences in terms of stroke, bleeds, death and according cost in a real-life setting.", - "NCTID": "NCT02615587" - }, - { - "brief_title": "Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women?", - "phase": "Phase 2; Phase 3", - "drugs": "['Smoking cessation treatment plus moderate intensity exercise', 'Smoking cessation treatment plus health education']", - "drugs_list": [ - "Smoking cessation treatment plus moderate intensity exercise", - "Smoking cessation treatment plus health education" - ], - "diseases": "['Lung Cancer', 'Heart Disease', 'COPD']", - "diseases_list": [ - "Lung Cancer", - "Heart Disease", - "COPD" - ], - "enrollment": "59.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy sedentary smokers (> 4 per day for at least one year) \n\n Ages 18 to 65 years \n\n Must be able to give informed consent \n\n Must live in the area for the next 3 months \n\n Willing to use the nicotine patch to attempt smoking cessation \n\n Must receive consent to participate from primary care physician \n\n ", - "exclusion_criteria": ": \n\n Cannot read or write fluently in the English language \n\n Pregnancy or plans to attempt pregnancy \n\n 60 minutes or more per week of moderate or vigorous physical activity \n\n Smokes cigars, pipes, or uses smokeless tobacco at least once per week \n\n Currently in a quit smoking program \n\n Currently using NRT of any kind or using any other quit smoking method or treatment \n\n Never had an adverse reaction to the nicotine patch resulting in discontinuation of use \n\n Poor willingness or inability to comply with protocol requirements \n\n An employee of the Centers for Behavioral and Preventive Medicine \n\n Previous participant in Commit to Quit or Fit to Quit smoking cessation studies \n\n Another member of the household is or has been enrolled in this study \n\n Currently taking a medication that might impact heart rate response, including but not limited to: \n\n Acebutolol Atenolol Carvedilol Metoprolol Nadolol Pindolol Propranolol Timolol \n\n Medical problems: \n\n Cardiac disease of any kind such as angina, a history of myocardial infarction or valve disease including mitral valve prolapse. Anyone with an interventional procedure such as a stent \n\n Pain, discomfort (or other anginal equivalent) in the chest, neck, jaw, arms or other areas that may be due to ischemia \n\n Cerebrovasular disease such as stroke or history of transient ischemic attacks \n\n Peripheral vascular disease (such as claudication) \n\n Diabetes (both Type I and II) \n\n Chronic infectious disease (HIV, hepatitis) (hepatitis A is okay) \n\n Liver disease \n\n Cystic fibrosis (CF) \n\n Chronic obstructive pulmonary disease (COPD) (see asthma and bronchitis under questionable) \n\n Interstitial lung disease \n\n Emphysema \n\n Chronic Bronchitis \n\n Orthopnea (difficulty breathing except in the upright position) or paroxysmal nocturnal dyspnea (sudden shortness of breath at night typically triggered by lying down) \n\n Current diagnosis of Chronic Fatigue Syndrome \n\n Current diagnosis of Fibromyalgia \n\n Abnormal exercise stress test \n\n Hypertension (anyone currently being followed and/or treated for hypertension) \n\n Cancer treatment (other than skin cancer) within the past 6 months \n\n Musculoskeletal problems such as osteoarthritis, gout, osteoporosis or back, hip or knee pain that can interfere with physical activity (i.e., walking at a brisk pace - about 3-mph) \n\n Any other serious medical condition that might make exercise unsafe or unwise \n\n Psychiatric Problems \n\n Hospitalization for a psychiatric disorder in the last 6 months \n\n Currently suicidal or psychotic, (or suicidal/psychotic in last 6 months) \n\n Self-report of more than three alcoholic drinks per day on 5 or more days; 5 or more alcoholic drinks on 3 or more days \n\n Taking these specific medications for psychiatric problems: Mood stabilizer (Lithium, Depakote, Neurontin), Antipsychotics (Haldol, Clozaril, Risperdal) \n\n Must be on other current psychiatric medications for at least three months \n\n REQUIRES MD CONSENT FOR THE SPECIFIC CONDITION \n\n Lightheadedness, dizziness, vertigo, or fainting \n\n Last electrocardiogram (EKG) performed was abnormal \n\n Anemia \n\n Previous ETT for medical reason with normal results \n\n Irregular heart beats or palpitations in the past two years \n\n Heart murmurs in the past two years - the person will need physician's consent and an echocardiogram showing no evidence of significant heart disease", - "brief_summary": "This study compares the effects of a standard smoking cessation treatment, including one-time brief counseling and provision of nicotine patch plus an 8-week moderate intensity exercise program versus the same standard smoking cessation treatment plus equivalent contact control among 60 healthy women. We hypothesize that participants in the smoking cessation plus moderate intensity exercise condition will be more likely to quit smoking than participants in the smoking cessation treament plus contact control condition.", - "NCTID": "NCT00420160" - }, - { - "brief_title": "Angiotensin II Receptor Blockers (ARB) and ACE Inhibitors (ACEI) on Silent Brain Infarction and Cognitive Decline", - "phase": "Phase 4", - "drugs": "['Angiotensin II Receptor Antagonists', 'Angiotensin-converting Enzyme Inhibitors']", - "drugs_list": [ - "Angiotensin II Receptor Antagonists", - "Angiotensin-converting Enzyme Inhibitors" - ], - "diseases": "['Brain Infarction', 'Hypertension']", - "diseases_list": [ - "Brain Infarction", - "Hypertension" - ], - "enrollment": "395.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with essential hypertension (systolic blood pressure>=140 mmHg and/or diastolic blood pressure>=90, or treated with antihypertensive drugs) \n\n Patients with any finding of stroke, silent brain infarction, and white matter lesion on magnetic resonance imaging \n\n ", - "exclusion_criteria": ": \n\n Secondary hypertension \n\n Atrial fibrillation \n\n History or signs of cerebral disorders other than cerebrovascular disease \n\n Malignant tumor \n\n Chronic renal failure \n\n Severe congestive heart failure \n\n Hyperkalemia \n\n Stenosis of bilateral renal artery", - "brief_summary": "The purpose of this study is to elucidate whether or not angiotensin II receptor blockers (ARB) are more beneficial or equal to angiotensin converting enzyme inhibitors (ACEI) on development or progression of silent brain infarction and cognitive decline in Japanese patients with essential hypertension in the elderly.", - "NCTID": "NCT00126516" - }, - { - "brief_title": "The Signal-averaged ElectrocArdiogram in Long Term Follow-up of Chronic CHagas Disease - RIO de Janeiro Cohort", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cardiac Arrhythmia', 'Stroke', 'Left Ventricular Function Systolic Dysfunction', 'Cardiac Death', 'Chagas Cardiomyopathy']", - "diseases_list": [ - "Cardiac Arrhythmia", - "Stroke", - "Left Ventricular Function Systolic Dysfunction", - "Cardiac Death", - "Chagas Cardiomyopathy" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinically stable outpatients with at least 10 years of regular outpatients follow-up and positive epidemiological history and serological confirmation of Chagas disease with ate least two immunological tests \n\n ", - "exclusion_criteria": ": \n\n Any degree of atrioventricular block or non-sinus rhythm \n\n Previous documented acute coronary events (due to documented obstructive epicardial coronary vessels) \n\n Chronic obstructive pulmonary disease \n\n Rheumatic valvular heart disease \n\n Alcohol addiction \n\n Thyroid dysfunction \n\n Abnormal serum electrolytes and biochemical abnormalities", - "brief_summary": "The study investigated 100 subjects, both genders, with chronic Chagas disease, confirmed by at least two distinct serological tests, and classified according to Los Andes classification in a long term follow-up aiming at identifying the predictive value of the signal-averaged electrocardiogram for cardiac death and ventricular tachycardia.~All subjects admitted to the study were submitted to clinical history taking, physical examination, and noninvasive assessment, including blood pressure measurement, resting 12-lead surface electrocardiogram, 24h ambulatory electrocardiogram monitoring, M-Mode/two-dimensional echocardiogram, signal-averaged electrocardiogram in both time and frequency domains. Selected subjects were further submitted to treadmill stress test and coronary angiography to rule out coronary heart disease.~Subjects were followed by non-investigational primary care assistance at three to six months scheduled clinical visits on an outpatients basis. Both noninvasive and invasive evaluation during follow-up were requested at discretion of primary evaluation. Adverse outcomes were ascertained by review of medical records and active contact to either study subjects or their relatives.", - "NCTID": "NCT01340963" - }, - { - "brief_title": "Study With Migraid Device in Acute, Early Treatment of Migraine With Typical Aura", - "phase": "", - "drugs": "['Migraid']", - "drugs_list": [ - "Migraid" - ], - "diseases": "['Migraine With Typical Aura']", - "diseases_list": [ - "Migraine With Typical Aura" - ], - "enrollment": "134.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients must have a current history of migraine with typical aura where the aura is usually followed by headache according to the International Headache Society (IHS) criteria. \n\n Patients are male or female. N.B. When female patients are treated for migraine attacks with triptans then the required precautions and safety measures should be taken in order to prevent pregnancy. \n\n Patients with an age between 18 and 65 years. \n\n Patients must have experienced 1-4 moderate (grade 2) or severe (grade 3) migraine attacks per month for at least two months prior to entry into the study. \n\n Patients must be willing to keep their prophylactic drug treatment for migraine unchanged. \n\n Patients must be able to distinguish migraine headaches from other headache types (e.g. tension-type headaches) at the onset of a migraine attack. \n\n Patients must be able to understand and complete the diary card \n\n Patients must be willing and able to give written informed consent prior to entry into the study. \n\n Patients must be willing and able to carry the Migraid and, if necessary, apply it in a public place. \n\n ", - "exclusion_criteria": ": \n\n Migraine patients with a typical aura but without any migraine headache thereafter. \n\n Patients with a history suggestive of ischaemic heart disease (IHD) or any present evidence of ischaemic heart disease (like angina pectoris, previous myocardial infarction, documented silent ischaemia, Prinzmetal's angina), or symptoms consistent with IHD. \n\n Patients suffering from coronary vasospasm or any atherosclerotic disease (cerebrovascular disease [CVD], peripheral vascular disease [PVD] or Raynaud's disease) which places them at increased risk of coronary ischaemia. \n\n Patients with a history of cerebrovascular accident (CVA) or transient ischaemic attacks (TIA). \n\n Patients with a supine diastolic blood pressure of > 95 mm Hg and/or systolic blood pressure > 160 mm Hg (treated or untreated) at Visit 1. \n\n Patients with a history of epilepsy or structural brain lesions which lower their convulsion threshold. \n\n Patients with tension-type headaches > 15 days/month in either of the two months prior to the study. \n\n Current abuse of opioid analgesics or other psychotropic drugs. History (within the past year) or current abuse of ergotamine (abuse as defined as > 10 mg/week). Current abuse of alcohol (according to local recommendations) or other drugs. \n\n Patients suffering from any severe concurrent medical condition which may affect the interpretation of efficacy and safety data or which otherwise contraindicates participation in a clinical study. \n\n Patients with a history of ophthalmoplegic, basilar or hemiplegic migraine. \n\n Patients with a history of impaired hepatic or renal function. \n\n Patients who have participated in a clinical trial within the previous 3 months or are planning to participate in another clinical research study at any time during this study. \n\n Patients with any concurrent medical or psychiatric condition that, in the investigator's opinion, may affect the interpretation of efficacy or safety data or which otherwise contraindicates participation in a clinical trial. \n\n Patients cannot be participating investigators, study co-ordinators, employees of investigators, or family members of any of the aforementioned.", - "brief_summary": "The purpose of the study was to assess the efficacy of Migraid in terms of preventing headaches in patients with migraine with typical aura. The secondary objectives were to assess whether Migraid is able to achieve pain relief and/or relief of migraine associated symptoms and to evaluate the safety and tolerability of the study treatment.", - "NCTID": "NCT00126035" - }, - { - "brief_title": "A Study of Pre-hospital Treatment of Acute Myocardial Infarction Based on Diagnosis by Interpretation of Remotely Acquired ECG and Thrombolysis With Accelerated Alteplase ( Actilyse\u00ae)", - "phase": "", - "drugs": "['Alteplase (Actilyse)', 'Standard therapy']", - "drugs_list": [ - "Alteplase (Actilyse)", - "Standard therapy" - ], - "diseases": "['Myocardial Infarction']", - "diseases_list": [ - "Myocardial Infarction" - ], - "enrollment": "59.0", - "inclusion_criteria": "inclusion criteria: \n\n Ischemic cardiac pain of >= 20 minutes and <= 6 hours \n\n Age 18 - 80 years \n\n Ability to give informed consent (witnessed verbal or written) \n\n Ability to follow protocol and comply with follow -up requirements \n\n ", - "exclusion_criteria": ": \n\n Current participation in another clinical trial \n\n Patient will be ineligible for pre hospital administration of actilyse if any of the following apply: \n\n Acute myocardial infarction (AMI) treated with a thrombolytic agent within the preceding 4 days \n\n BP (blood pressure) > 180/100 mmHg (on one measurement) \n\n Significant bleeding disorder within the past 6 months \n\n Major surgery, biopsy of a parenchymal organ, or significant trauma (including any trauma associated with the current AMI) within 3 months \n\n History of stroke, transient ischaemic attack, or central nervous system structural damage (e.g. neoplasm, aneurysm, intracranial surgery) \n\n Oral anticoagulation \n\n Recent (within 10 days) non - compressible vascular puncture \n\n Pregnancy (positive urine pregnancy test) or lactation, parturition within the previous 30 days, or female of childbearing potential not using adequate birth control (oral contraception) \n\n Severe liver disease, including hepatic failure, cirrhosis portal hypertension (oesophageal varices) and active hepatitis \n\n Diabetes with definite history of retinopathy \n\n Other serious illness (e.g. malignancy, active infection) \n\n Bacterial endocarditis / pericarditis \n\n Acute pancreatitis \n\n Documented ulcerative gastrointestinal disease during last 3 month, arterial aneurysms, arterial / venous malformations \n\n Any other condition that the investigator feels would pose a significant hazard to the subject if the investigational therapy was to be initiated \n\n Patients who are not excluded from thrombolytic therapy by the criteria above will, in addition, need to satisfy the following 'inclusion' criteria prior to the pre - hospital thrombolysis: \n\n 12 lead ECG criteria: ST segment elevation >= 0.1 mV in two contiguous electrocardiogram (ECG) standard leads indicative of AMI, or ST elevation >= 0.2 mV in two contiguous chest leads and all left bundle branch block (LBBB) with clinical indication of AMI", - "brief_summary": "The general aim of this study was to assess the feasibility of treating acute myocardial infarction (AMI) by physician-directed pre-hospital thrombosis, using accelerated alteplase (Actilyse\u00ae) and a diagnostic technique involving remote electrocardiogram (ECG) acquisition by paramedics", - "NCTID": "NCT02235389" - }, - { - "brief_title": "Thrombolysis Versus Primary Angioplasty for AMI in Elderly Patients", - "phase": "Phase 4", - "drugs": "['Tenecteplase + UFH (+ clopidogrel, since 01/97)', 'Primary angioplasty']", - "drugs_list": [ - "Tenecteplase + UFH (+ clopidogrel", - "since 01/97)", - "Primary angioplasty" - ], - "diseases": "['Acute Myocardial Infarction']", - "diseases_list": [ - "Acute Myocardial Infarction" - ], - "enrollment": "266.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects of 75 or more years of age \n\n Diagnosis of AMI: chest pain or any symptom of myocardial ischemia of, at least, 20 minutes of duration, not responding to nitrate therapy, an evolution period of less than 6 hours after symptom onset until randomization process, and, at least, one of the following alterations: \n\n ST-elevation >=2 mm in 2 or more precordial leads \n\n ST-elevation >=1 mm in 2 or more anterior leads \n\n Complete de novo (or probably de novo) left bundle branch block (LBBB) \n\n Subject should be able to give informed consent prior to randomization process and should agree to fulfill all procedures described in the protocol, including follow-up after hospital discharge. A written consent signed by a close relative with witness is also acceptable. \n\n ", - "exclusion_criteria": ": \n\n Documented contraindication to the use of fibrinolytics. 1.1. Internal active bleeding or known history of hemorrhagic diathesis 1.2. History of previous CVA of any kind or at any time 1.3. Intracranial tumor, arteriovenous malformation, aneurysm or cerebral aneurysm repair 1.4. Major surgery, parenchymal biopsy, ocular surgery or severe traumatism in the 6 weeks prior to randomization 1.5. Unexplained puncture in a non-compressible vascular location in the last 24 hours prior to randomization 1.6. Confirmed arterial hypertension with a reliable measurement of systolic AP >180 mmHg or diastolic AP >110 mmHg 1.7. Known thrombocytopenia < 100.000 platelets/mL 1.8. Prolonged (>20 minutes) or traumatic cardiopulmonar resuscitation (CPR) in the 2 weeks prior to randomization 1.9. History or signs suggesting aortic dissection \n\n Cardiogenic shock \n\n Estimated door-to-needle time >120 minutes \n\n Administration of fibrinolysis in the 14 days prior to randomization \n\n Administration of any glycoprotein IIa/IIIb inhibitor in the 24 hours prior to randomization \n\n Administration of any Low Molecular Weight Heparin (LMWH) in the 8 hours prior to randomization \n\n Actual oral anticoagulant treatment \n\n Suspected AMI secondary to occlusion of one lesion treated previously with a percutaneous coronary intervention (within the previous 30 days for angioplasty or conventional stent and within the previous 12 months for coated stents) \n\n Dementia or acute confusional state at the time of randomization \n\n Subject incapacity or unwillingness to give informed consent -at least, verbally \n\n Known renal failure (basal creatinine> 2,5 mg/dl) \n\n Reduced life expectancy (<12 months) due to advanced or terminal concomitant condition \n\n Subject participation in another clinical trial (assessing a drug or a device) in the 30 days prior to randomization", - "brief_summary": "General objective: To compare the efficacy and safety of primary angioplasty(PA) with that of thrombolytic therapy (TT) for the treatment of AMI in patients >=75 years old with ST-segment elevation or LBBB AMI <6 hours of evolution without contraindications for TT.~Hypothesis: The therapeutical strategy based on PA is superior to that based initially on TT in patients >=75 years old with AMI.~Participating Centers: 27 Spanish hospitals performing >50 PA/year. Primary Endpoint (PE): Incidence of the aggregate of death of any cause, reinfarction or disabling stroke at 30 days. There are also 7 secondary endpoints (SE).~Procedure: Diagnosis of inclusion/exclusion criteria --> Centralized randomization --> Treatment allocation to 1) TT with weight adjusted TNK + unfractionated heparin or 2) PA within 120 minutes. Estimated Sample size and recruitment time: 570 patients in 19 months. Follow-up: Blinded evaluation of events (PROBE regulations) specified in PE and SE at 30 days and 12 months. Quality control: 100% variable and follow-up review by external CRO. Safety Committee and Event Adjudication Committee formed by experts not participating in the study.", - "NCTID": "NCT00257309" - }, - { - "brief_title": "Postoperative Atrial Fibrillation and Long-term Survival", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Death', 'Stroke', 'Myocardial Infarction']", - "diseases_list": [ - "Death", - "Stroke", - "Myocardial Infarction" - ], - "enrollment": "519.0", - "inclusion_criteria": "inclusion criteria: \n\n previously cardiac operation, CABG or AVR \n\n ", - "exclusion_criteria": ": \n\n Previous Atrial fibrillation", - "brief_summary": "The aim of the investigators trial was to evaluate association between new onset postoperative atrial fibrillation (POAF) and late cardiovascular morbidity and mortality.", - "NCTID": "NCT02349269" - }, - { - "brief_title": "Endothelial Cell Dysfunction in Pulmonary Hypertension", - "phase": "Phase 1", - "drugs": "['Heart Catheterization']", - "drugs_list": [ - "Heart Catheterization" - ], - "diseases": "['Secondary Pulmonary Arterial Hypertension']", - "diseases_list": [ - "Secondary Pulmonary Arterial Hypertension" - ], - "enrollment": "27.0", - "inclusion_criteria": "ELIGIBILITY CRITERIA: \n\n Pilot: The pilot study will enroll two groups of individuals: 1) patients who have either IPAH or a secondary form known to have similar histopathology (PAH), and 2) age, gender, and race matched control subjects for each patient. \n\n Main: The main study will enroll three groups of individuals: 1) patients who have either IPAH or a secondary form known to have similar histopathology (PAH), 2) patients with PH ascribed to a nonvascular injury process, and 3) age, gender, and race matched control subjects for each PAH patient. Subjects must be at least 18 years of age and must be able to provide informed, written consent for participation in this study. There is no exclusion based on race or gender. \n\n inclusion criteria FOR PULMONARY ARTERIAL HYPERTENSION PATIENTS: \n\n The inclusion criteria for this study are as follows: \n\n Patients diagnosed with IPAH \n\n Patients diagnosed with secondary pulmonary hypertension known to have histopathology similar to the primary form or PAH. Clinical conditions causing pulmonary hypertension with histopathology similar to the primary form are listed below. \n\n i. Eisenmenger Syndrome \n\n ii. Collagen vascular disease \n\n iii. Liver disease with portal hypertension \n\n iv. Toxin induced injury (anorexic agents, rapeseed oil) \n\n v. HIV disease \n\n vi. Sickle cell disease \n\n ", - "exclusion_criteria": " FOR PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION: \n\n Pregnant women (all women of childbearing age will be required to have a screening urine or blood pregnancy test) \n\n Age less than 18 years \n\n Inability to provide informed written consent for participation in the study \n\n Mean PA less than or equal to 25mmHg or PVR less than 3 wood units \n\n PCW greater than 16 mmHg unless increase accounted for by increased transpulmonary gradient greater than or equal to 10 mmHg \n\n Patients receiving more than 1 year of oral therapy or more than 6 months of IV therapy. \n\n inclusion criteria FOR PATIENTS WITH NONVASCULAR INJURY-INDUCED PULMONARY HYPERTENSION: \n\n The inclusion criteria are as follows: \n\n Patients diagnosed with pulmonary hypertension not known to have histopathology similar to the primary form. Etiologies are listed below. \n\n Congenital or acquired valvular or myocardial disease \n\n Pulmonary parasitic diseases \n\n Arterial hypoxemia with hypercapnea \n\n COPD with hypoxemia and forced expiratory volume/forced vital capacity (FEV1/FVC) greater than 2 standard deviations from normal \n\n Interstitial lung disease with reduced total lung capacity greater than 2 standard deviations from normal and infiltrates on chest x-ray \n\n Pulmonary thromboembolic disease as evidenced by lung perfusion scan or pulmonary angiogram, or intravenous drug abuse \n\n Pulmonary hypertension due to congenital abnormalities of the lungs, thorax and diaphragm \n\n ", - "brief_summary": "This study will examine and test healthy volunteers and patients with pulmonary hypertension to try to learn more about the disease and find better ways to detect, treat, and, if possible, slow progression. Pulmonary hypertension is a rare blood vessel disorder of the lung in which the pressure in the pulmonary artery (the blood vessel that leads from the heart to the lungs) rises above normal levels and may become life-threatening.~Normal volunteers and patients with pulmonary hypertension 18 years of age and older may be eligible for this study. All candidates are screened with a review of their medical records. Normal volunteers also have a medical history, electrocardiogram, echocardiogram (heart ultrasound), and pulmonary function test, in which the subject breathes in and out of a tube that measures lung volume, mechanics and function.~All participants undergo the following tests and procedures:~Echocardiogram to measure heart function and blood pressure in the lungs. A small probe held against the chest uses sound waves to obtain pictures of the heart.~Magnetic resonance imaging (MRI) to evaluate the heart's pumping action. Subjects lie on a stretcher that slides into a long, tube-shaped scanner. The machine uses a magnetic field and radio waves to obtain images of the heart.~6-minute walk to measure how far the subject can walk in 6 minutes. Subjects walk around the hospital for 6 minutes at a comfortable pace.~Exercise testing to measure the ability to exercise and the subject's oxygen levels during exercise. Subjects exercise on a bike or treadmill while the oxygen and carbon dioxide they breathe are measured using a small device placed in the mouth.~Right heart catheterization to measure pressure in the heart and lungs. A small catheter (plastic tube) is placed in an arm vein. A longer catheter called a central line is placed in a deeper vein in the neck or just below the neck, or in the leg or arm. A long, thin catheter that measures blood pressure directly is then inserted into the vein and advanced through the chambers of the heart into the lung artery to measure all the pressures in the heart and obtain blood samples.~Genetic and protein studies. DNA, RNA, and proteins from blood samples are studied for genes and proteins that might predict the development or progression of pulmonary hypertension.~In addition to the above, patients whose pulmonary hypertension was caused by a blood vessel injury undergo the tests described below. The right heart catheter inserted for the catheterization procedure remains in place to obtain measurements of the effects of nitric oxide and nitrite in the following procedures:~Inhalation of nitric oxide (a gas naturally produced by cells lining arteries) at 30-minute intervals to examine its effect on lung and heart pressures.~Inhalation of aerosolized nitrite at 5-minute intervals to measure its effects on lung and heart pressures.~Inhalation of nitric oxide for up to 24 hours to obtain multiple measurements of its effect on lung and heart pressures.~Blood draws for laboratory tests.~In patients whose pulmonary hypertension was caused by a blood vessel injury, we also plan to follow response to standard therapy. After the initiation of standard therapy, we will restudy the same parameters (excluding NO and sodium nitrite studies) in these patients at approximately 4 months, and yearly for 5 years", - "NCTID": "NCT00098072" - }, - { - "brief_title": "A Trial Using Double-Bolus THR-100 Versus Streptokinase", - "phase": "Phase 3", - "drugs": "['THR-100', 'Streptokinase']", - "drugs_list": [ - "THR-100", - "Streptokinase" - ], - "diseases": "['Acute Myocardial Infarction']", - "diseases_list": [ - "Acute Myocardial Infarction" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female patients aged 30 to < 75 years inclusive. \n\n Patients presenting within 12 hours with symptoms presumed secondary to an acute myocardial infarction lasting at least 20 minutes and accompanied by ECG evidence of > 1mm of ST elevation in 2 or more limb leads or > 2mm in 2 or more contiguous precordial leads or suspected new left bundle branch block will be eligible. \n\n Patients must be in the hospital or the emergency department and able to receive the study medication within 12 hours of onset of symptoms. \n\n Females of child-bearing age, not using a generally accepted method of contraception must have a negative urine pregnancy test. \n\n Written informed consent should be sought from the patient prior to inclusion in the study. If unable to do so, informed verbal consent will be obtained. If neither is possible, a legally acceptable representative (relative) should provide written consent. \n\n NB Verbal or written consent should be followed by written informed consent from the patient at the earliest subsequent opportunity. \n\n ", - "exclusion_criteria": ": \n\n Previous administration of staphylokinase. \n\n Active bleeding or known hemorrhagic diathesis. \n\n Any history of stroke, transient ischemic attack, dementia, or structural CNS damage e.g. neoplasm, aneurysm, AV malformation. \n\n Major surgery or trauma within the past 3 months. \n\n Significant hypertension i.e. SBP 180 mm Hg and/or DBP 110 mm Hg at any time from admission to randomization. \n\n Current treatment with vitamin K antagonists resulting with an INR > 1.5. \n\n Anticipated difficulty with vascular access. \n\n Prolonged (>10 min) cardiopulmonary resuscitation or cardiogenic shock. \n\n Patients who have participated in an investigational drug study within the past 30 days. \n\n Pregnancy or lactation, parturition within the previous 30 days. \n\n Any serious concomitant systemic or life limiting disorder that would be incompatible with the trial \n\n Patients known to have a history of or life limiting malignant disease or HIV. \n\n Significant hepatic or renal dysfunction or any other condition which, in the opinion of the Investigator, makes the patient unsuitable for study entry. \n\n Previous participation in this trial", - "brief_summary": "This novel fibrinolytic agent is a 136 amino acid single chain protein secreted by some strains of Staphylococcus aureus and readily produced by recombinant DNA technology. Two natural variants of recombinant staphylokinase, THR-100 and SakSTAR, have been developed for investigational use in preliminary trials. Like SK, it forms an equimolar complex with plasmin which in turn activates plasminogen to plasmin. Unlike SK, the complexed, activated molecule (which undergoes proteolytic cleavage of the first ten amino acids to generate active staphylokinase) has a high degree of fibrin-selectivity in a human plasma milieu. This fibrin-selectivity is due in large measure to potent activation at the clot surface by trace amounts of plasmin, and rapid inactivation of the circulating complex by antiplasmin. Hence, it provides an interesting and promising alternative therapy.", - "NCTID": "NCT01305226" - }, - { - "brief_title": "Identification of Genetic, Biochemical and Hormonal Factors Contributing to Atrial Fibrillation", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Atrial Fibrillation']", - "diseases_list": [ - "Atrial Fibrillation" - ], - "enrollment": "1300.0", - "inclusion_criteria": "inclusion criteria for Atrial Fibrillation group: \n\n Male or female at least 18 years old \n\n Subjects with a history of or current Atrial Fibrillation \n\n Subjects able to give informed consent ", - "exclusion_criteria": " for Atrial Fibrillation group: no history of atrial fibrillation \n\n inclusion criteria for Controls: \n\n Male or female at least 18 years old \n\n Subjects with no history of Atrial Fibrillation \n\n Subjects able to give informed consent ", - "brief_summary": "The purpose of this study is to establish a genebank repository of blood samples and data to generate information about the hereditary (genetic) basis of atrial fibrillation.", - "NCTID": "NCT00599118" - }, - { - "brief_title": "The Role of Heart Stiff and Weak Atrium on Exercise Capacity in Patients With Hypertrophic Cardiomyopathy", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cardiomyopathy, Hypertrophic']", - "diseases_list": [ - "Cardiomyopathy", - "Hypertrophic" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria - HCM Patients: \n\n HCM defined as maximal LV wall thickness by echocardiography greater than 13mm in the absence of other causes of LVH or greater than 15mm asymmetrical LV wall thickness if there is a history of mild hypertension (defined as systolic less than 160mmHg and diastolic less than 100mHg) controlled for greater than 6 months \n\n Non-obstructive HCM \n\n Age greater than or equal to 21 years. \n\n Patients with LV obstruction treated by LV myotomy and myectomy or percutaneous septal alcohol ablation that meet inclusion criteria are eligible for this study. \n\n ", - "exclusion_criteria": " - HCM Patients: \n\n LV outflow obstruction noted during Doppler echocardiography at rest or with Valsalva maneuver defined as instantaneous peak gradient greater than 30 mmHg \n\n Hemodynamically significant valvular disorders, history of significant coronary obstruction (greater than 50% in any single artery), angina symptoms, myocardial ischemia on an imaging stress test or evidence of prior myocardial infarction. Patients older than 40 years of age with effort induced anginal symptoms typical of coronary insufficiency and a coronary distribution of myocardial ischemia on an imaging stress test will be considered for the study if coronary angiography rules out significant obstructive coronary disease. \n\n Chronic atrial fibrillation \n\n Cardiac pacemaker or other metallic implant unsafe for MRI \n\n Uncontrolled hypertension \n\n Dependence on a beta blocker that cannot be withdrawn \n\n Dependence on a calcium blocker that cannot be withdrawn \n\n Current use of digoxin \n\n History of digitalis intolerance \n\n Renal failure \n\n Diabetes mellitus \n\n Pregnancy or lactation \n\n Failure to indicate effective method of birth control measures if female patient is of childbearing age. \n\n Inability to exercise or disease states likely to result in impaired exercise capacity (such as pulmonary, hematological and musculoskeletal disorders) \n\n Echocardiographic images of insufficient quality, even after administration of contrast agent, for volumetric analysis. \n\n Inability to provide informed consent", - "brief_summary": "This study will examine how heart stiffness and a weak atrium affect exercise capacity and symptoms in patients with hypertrophic cardiomyopathy (HCM). The atrium is the booster pumping chamber of the heart that helps the ventricle (main pumping chamber), to fill properly. HCM is an inherited disease in which the ventricle becomes thickened and, in some patients, stiff. The stiffness makes it difficult for the ventricle to fill and empty, causing breathing difficulty, fatigue, and reduced exercise capacity. Scar formation and a weakened atrium can cause the heart to stiffen. Information gained from this study may guide doctors in prescribing medicines to reduce scarring or improve atrial function.~Patients 21 years of age and older with hypertrophic cardiomyopathy may be eligible for this study. Candidates will be screened with a medical history and physical examination, electrocardiogram (EKG), blood tests, Holter monitor, and echocardiogram. A Holter monitor is a device about the size of a Walkman that is connected to three wires that are attached to the chest. It is worn for 24 hours to provide continuous monitoring of heart rhythm. An echocardiogram uses a small probe that emits sound waves to produce images of the heart. The probe is moved across the chest and the reflection of the sound waves from the chambers of the heart produce images showing the heart's thickness and function.~Participants will undergo the following tests and procedures over 3 days:~Physical examination and echocardiogram.~Intravenous cannula insertion: A plastic tube is inserted into an arm vein for collecting blood samples to measure substances that the heart and circulatory system release at rest and during exercise.~Impedance cardiography: A small current of electricity is passed across the chest and electrodes similar to those used for an EKG test are placed to measure blood flow in the area of the current.~Pulmonary artery catheterization: A catheter (plastic tube) is inserted into a vein either in the arm, under the collarbone, or in the neck and advanced to the right atrium and ventricle. The catheter remains in place during the echocardiogram tilt and bicycle exercise tests (see below).~Echocardiogram tilt test: The patient lies flat on a table. After a few minutes, the table is tilted so that the patient's head is just above his or her feet for a short while, then is positioned flat again, and then tilted so the feet are just above the head. Echocardiographic measurements and blood samples are taken at intervals to examine heart function during changes in posture.~Echocardiogram bicycle stress test: The patient exercises for as long as possible on a bicycle-like machine while lying on his or her back. Echocardiographic measurements and blood samples are taken at intervals during the test.~Treadmill stress test: The patient runs for as long as possible on a treadmill that increases in difficulty. The patient wears a facemask or mouthpiece through which small amounts of gases are added in order to measure the ability of the heart and lung to increase their effectiveness with exercise.~Digoxin loading: Only patients who demonstrate limited exercise capacity and for whom digoxin is not a risk will undergo this procedure. A medicine that makes the heart contract more strongly, digoxin is used to treat certain heart abnormalities. Patients are given doses of either digoxin or placebo (a look-alike injection with no active ingredient) at 4-hour intervals over a 24-hour period and then repeat the tilt test and the bicycle and treadmill exercise tests", - "NCTID": "NCT00074880" - }, - { - "brief_title": "Incidence of Male Pudendal Artery Stenosis in Suboptimal Erections Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Erectile Dysfunction Due to Arterial Insufficiency']", - "diseases_list": [ - "Erectile Dysfunction Due to Arterial Insufficiency" - ], - "enrollment": "19.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject must be undergoing coronary or peripheral angiography for suspected or known coronary or peripheral atherosclerotic disease \n\n Subject must be male \u2265 35 and \u2264 70 years old \n\n Subject must provide written informed consent before any study-related procedures are performed \n\n Subject must agree to comply with study procedures and follow-up for the entire length of the study \n\n ", - "exclusion_criteria": ": \n\n Subject is unable to safely attempt sexual intercourse secondary to severe cardiac disease or other health condition \n\n Subject has a life expectancy of < 12 months \n\n Subject's serum creatinine is > 2.5 mg/dl \n\n Subject has known aorto-iliac occlusive disease, previous AAA endograft procedure or open surgical procedure \n\n Subject has history of prostatic carcinoma requiring surgery (i.e., prostatectomy), pelvic radiation, or hormonal/chemotherapy \n\n Subject has a history of myocardial infarction, stroke, life-threatening arrhythmia, or unstable angina requiring hospitalization within 3 months (90 days) prior to enrollment \n\n Subject has had exposure to PDE5 inhibitor (per subject's concomitant medication list) within the 72 hours prior to the scheduled baseline angiography \n\n Subject has a history of renal transplantation \n\n Subject has a penile implant \n\n Subject has become unstable or has received a maximum radiation dose, increased procedure time, and/or maximum contrast dose (in the Investigator's opinion) from the primary angiographic procedure that would compromise the safety of the subject by proceeding with enrollment into the IMPASSE study", - "brief_summary": "The purpose of this study is to determine the proportion of men with known or suspected coronary artery disease (CAD) and/or peripheral arterial disease (PAD) that have angiographic identifiable erectile related artery (ERA) atherosclerotic disease defined as at least one ERA stenosis greater than or equal to 50% (per core lab Quantitative Vascular Analysis - QVA).", - "NCTID": "NCT01341483" - }, - { - "brief_title": "Glucose Metabolism, Muscle Mass/Function and Inflammation in the Elderly", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Sarcopenia', 'Diabetes Mellitus']", - "diseases_list": [ - "Sarcopenia", - "Diabetes Mellitus" - ], - "enrollment": "76.0", - "inclusion_criteria": "inclusion criteria: \n\n Type 2 diabetes mellitus: patients taking drugs for diabetes will be diagnosed as having diabetes. In all other patients, a diagnosis will be established according to the criteria of the American Diabetes Association \n\n Sarcopenia (non-severe): individuals with low muscle mass and either low muscle strength or low physical performance will be diagnosed with sarcopenia, according to the criteria of the European Working Group on Sarcopenia in Older People (EWGSOP) \n\n Healthy volunteers: no diabetes, no sarcopenia and none of the ", - "exclusion_criteria": " \n\n ", - "brief_summary": "A thorough characterization of glucose metabolism and inflammaging in elderly subjects will help determine to what extent each of these factors affects muscle mass/function and contributes to age-related muscle wasting. The investigators will correlate patterns of insulin secretion/sensitivity with muscle quality/quantity in diabetic and non-diabetic elderlies (\u226570 years old). By comparing different groups (healthy, sarcopenic, diabetic, diabetic/sarcopenic), the investigators expect to identify an oxidative/inflammatory signature (e.g., circulating interleukins/myokines, plasma antioxidant capacity) specific for the sarcopenic phenotype and related to muscle insulin resistance.", - "NCTID": "NCT02426073" - }, - { - "brief_title": "Safety and Efficacy of Cryoballoon Ablation of Atrial Fibrillation as First-line Therapy", - "phase": "", - "drugs": "['Cryoballoon ablation']", - "drugs_list": [ - "Cryoballoon ablation" - ], - "diseases": "['Paroxysmal Atrial Fibrillation']", - "diseases_list": [ - "Paroxysmal Atrial Fibrillation" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n paroxysmal atrial fibrillation, symptomatic \n\n ", - "exclusion_criteria": ": \n\n atrial fibrillation other than PAF, asymptomatic, previous AF ablation", - "brief_summary": "Cryoballoon ablation of paroxysmal atrial fibrillation can be used as first-line therapy compared to second choice after failed medical therapy", - "NCTID": "NCT01920295" - }, - { - "brief_title": "Effect of Exercise on Risk-factors of Elderly Women", - "phase": "Phase 3", - "drugs": "['physical exercise, wellness']", - "drugs_list": [ - "physical exercise", - "wellness" - ], - "diseases": "['Atrophy']", - "diseases_list": [ - "Atrophy" - ], - "enrollment": "246.0", - "inclusion_criteria": "inclusion criteria: \n\n Community living Caucasian woman \u2265 65 years; live expectation > 2 years \n\n ", - "exclusion_criteria": ": \n\n secondary osteoporosis \n\n CVD-events including stroke \n\n Participation in other studies \n\n Medication with impact on bone during the last 2 years: \n\n bisphosphonates \n\n parathormone \n\n strontium \n\n HRT, anabolic steroids \n\n calcitonin \n\n natriumflourides \n\n active Vit-D-metabolites \n\n cortisone > 5 mg/d \n\n medication with impact on falls \n\n low physical performance (<50 Watt during ergometry) \n\n excessive alcohol-intake", - "brief_summary": "The purpose of this study is to determine whether exercise training may impact relevant risk factors and health costs of community living women older 65 years.", - "NCTID": "NCT00267839" - }, - { - "brief_title": "Manual vs Amigo SmartTouch Atrial Fibrillation Study", - "phase": "", - "drugs": "['Catheter ablation for atrial fibrillation, manual', 'Ablation using Amigo remote catheter system']", - "drugs_list": [ - "Catheter ablation for atrial fibrillation", - "manual", - "Ablation using Amigo remote catheter system" - ], - "diseases": "['Atrial Fibrillation']", - "diseases_list": [ - "Atrial Fibrillation" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n atrial fibrillation \n\n scheduled for catheter ablation \n\n ", - "exclusion_criteria": ": \n\n contraindication to magnetic resonance imaging \n\n pregnancy \n\n life expectancy of less than six months \n\n participation in another trial that would conflict with this trial", - "brief_summary": "Atrial fibrillation is a common form of heart rhythm disturbance that for some patients is treated by catheter ablation (making an ablation lesion or burn inside the heart using a fine wire (catheter)). A new system for manipulating the catheters has recently been introduced into clinical practice (the Amigo Remote Catheter System (RCS)). This trial is designed to answer two primary questions: a) is the contact force (the force with which the catheter comes into contact with the heart) any different using the RCS to manual techniques,and b)are the resulting ablation lesions within the heart any different in terms of the volume and contiguity of the lesions produced. Additionally the investigators aim to determine how the two techniques compare in success (the proportion of patients whose heart rhythm disturbance is corrected by the procedure).", - "NCTID": "NCT01583855" - }, - { - "brief_title": "Erythropoietin in Radiocontrast Induced Nephropathy (ERIN) Trial", - "phase": "Phase 4", - "drugs": "['erythropoeitin']", - "drugs_list": [ - "erythropoeitin" - ], - "diseases": "['Contrast Induced Nephropathy']", - "diseases_list": [ - "Contrast Induced Nephropathy" - ], - "enrollment": "17.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects age 18 and over and of either gender. \n\n Scheduled to receive CT scan with intravenous contrast dye. \n\n Non diabetics or subjects with type 1 or 2 diabetes mellitus \n\n Written informed consent. \n\n Subjects who are on diuretics and non-steroidal inflammatory agents will not be excluded. \n\n Subjects who have received n-acetylcysteine or sodium bicarbonate pre CT scan will not be excluded \n\n ", - "exclusion_criteria": ": \n\n Pregnant or lactating women. \n\n End-stage renal disease (on hemodialysis or peritoneal dialysis) \n\n A known history of acute renal failure \n\n Subjects receiving glucophage/metformin or glucovance \n\n Subjects who cannot give written informed consent. \n\n Subjects receiving peritoneal dialysis or hemodialysis. \n\n Subjects enrolled in another investigational drug study \u2264 30 days of enrollment into the present study. \n\n Subjects with a known hypersensitivity or anaphylaxis to contrast dye or iodine. \n\n Subjects with known hypersensitivity or anaphylaxis to erythropoietin, mammalian-cell derived products, or human albumin. \n\n Age < 18 years \n\n Use of any erythropoietin replacement or transfusion within the prior 3 days \n\n Baseline Hemoglobin > 12.0 g/dL \n\n Uncontrolled hypertension, systolic BP > 180 mmHg or diastolic BP > 110 mmHg in any recording in the past 24 hours. \n\n Evidence of hemodynamic instability \n\n Subject unable to follow protocol due to mental incompetence or other reason \n\n Inaccessibility of medical record \n\n Subjects with a history of MI, CVA, active angina or unstable angina within the past three months \n\n Subjects with a history of current malignancy, where current malignancy is defined as subjects undergoing treatment with chemotherapy or radiation therapy, subjects with known metastatic disease, and those with terminal malignant disease. \n\n Subject with any known history of seizure disorders", - "brief_summary": "Full Title: A Randomized Controlled Trial of Procrit for the Prevention of Acute Renal Failure in Patients Receiving Intravenous Contrast~Primary Objective: To evaluate the efficacy of a one-time dose of intravenous erythropoietin administration in the prevention or attenuation of contrast-induced acute renal failure.~Secondary Objectives: To evaluate serum and urinary markers of renal injury, including KIM-1, BMP-7, and TGF-b, along with other biomarkers, in subjects receiving intravenous contrast and correlate their expression with clinical outcomes~Study Design: Prospective, multi-centered, randomized, double blind, placebo controlled trial of a one-time dose of EPO. Subjects will be followed for seven days or until hospital discharge, whichever is longer. Total estimated study duration 3 years.", - "NCTID": "NCT00476619" - }, - { - "brief_title": "Low Dose Prolonged Infusion of Tissue Type Plasminogen Activator Therapy in Massive Pulmonary Embolism", - "phase": "Phase 4", - "drugs": "['25 mg Actilyse ( Boehringer Ingelheim, Germany) infusion in 6 hours']", - "drugs_list": [ - "25 mg Actilyse ( Boehringer Ingelheim", - "Germany) infusion in 6 hours" - ], - "diseases": "['Pulmonary Embolism']", - "diseases_list": [ - "Pulmonary Embolism" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with massive PE aged 18 years or older with confirmed PE and able to give informed consent will be included in the study. PE is defined according to current guidelines as adult patients presenting with signs and symptoms suggestive of PE plus imaging documentation on computed tomography angiography. Massive PE was defined as acute PE with sustained hypotension (systolic blood pressure<90 mm Hg for at least 15 minutes or requiring inotropic support, not due to a cause other than PE, such as arrhythmia, hypovolemia, sepsis, or left ventricular [LV] dysfunction), pulselessness, or persistent profound bradycardia (heart rate<40 bpm with signs or symptoms of shock). \n\n ", - "exclusion_criteria": ": \n\n Patients with prior intracranial hemorrhage, known structural intracranial cerebrovascular disease (eg, arteriovenous malformation), known malignant intracranial neoplasm, ischemic stroke within 3 months, suspected aortic dissection, active bleeding or bleeding diathesis, recent surgery encroaching on the spinal canal or brain, and recent significant closed-head or facial trauma with radiographic evidence of bony fracture or brain injury were excluded from the study.", - "brief_summary": "The aim of the present study was to assess the effects of low-dose (25mg) prolonged administration (in 6 hours) of tissue type plasminogen activator (tPA) on in-hospital mortality and outcomes in patients with massive PE.", - "NCTID": "NCT02029456" - } - ], - "1": [ - { - "brief_title": "Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale (DEFENSE-PFO)", - "phase": "Phase 4", - "drugs": "['Device closure', 'Standard medical treatment']", - "drugs_list": [ - "Device closure", - "Standard medical treatment" - ], - "diseases": "['Patent Foramen Ovale']", - "diseases_list": [ - "Patent Foramen Ovale" - ], - "enrollment": "210.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects who have had a cryptogenic stroke within the previous 3 months, radiologically verified \n\n Subjects who have been diagnosed with a high-risk* Patent Foramen Ovale (PFO), echocardiographically verified (*PFO size \u2265 2 mm or atrial septal aneurysm or hypermobility by TEE) \n\n Subjects willing to participate in follow-up visits \n\n Absence of other potential causes of stroke \n\n ", - "exclusion_criteria": ": \n\n Any identifiable cause of thromboembolic cause other than PFO \n\n Subjects with intracardiac thrombus or tumor, dilated cardiomyopathy, prosthetic heart valve or mitral stenosis, endocarditis \n\n Subjects with significant atherosclerosis or dissection of the aorta, collagen vascular disease, arteritis, vasculitis and coagulopathy \n\n Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina \n\n Subjects who have a non-vascular origin of the neurological symptoms after brain imaging (CT scan or MRI) \n\n History of intracranial bleeding, confirmed arterio-venous malformation,aneurysm or uncontrolled coagulopathy \n\n Pre-existing neurological disorders or intracranial disease, e.g. multiple sclerosis \n\n Subjects with left ventricular aneurysm or akinesis \n\n Subjects with atrial fibrillation/atrial flutter (chronic or intermittent) \n\n Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum \n\n Subjects who could not undergo the TEE examination \n\n Subjects with contraindication to aspirin or Clopidogrel therapy \n\n Pregnant or desire to become pregnant within the next year \n\n Subjects who have a underlying malignancy", - "brief_summary": "Background and hypothesis:~The appropriate treatment strategy for secondary stroke prevention in patients with cryptogenic stroke and patent foramen ovale (PFO) remains challenging. Clinical and anatomical variables reported to be risk factors associated with stroke recurrence include older age, large PFO, large right-to-left shunting, and combined atrial septal aneurysm (ASA), which, however, were not confirmed by other studies. The investigators hypothesized that percutaneous closure of PFO could be an effective option for secondary prevention in cryptogenic stroke patients with high-risk PFO.~Trial Objective:~The primary objective of this study is to assess whether percutaneous device closure of PFO is superior to conventional antithrombotic treatment in preventing stroke recurrence in the cryptogenic stroke patients with high-risk PFO.", - "NCTID": "NCT01550588" - }, - { - "brief_title": "Improving Blood Pressure Management in Patients With Diabetes", - "phase": "Phase 4", - "drugs": "['Lifestyle Counselling; Opinion Leader Influence Statements']", - "drugs_list": [ - "Lifestyle Counselling; Opinion Leader Influence Statements" - ], - "diseases": "['Hypertension', 'Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']", - "diseases_list": [ - "Hypertension", - "Diabetes Mellitus", - "Type 1", - "Diabetes Mellitus", - "Type 2" - ], - "enrollment": "227.0", - "inclusion_criteria": "inclusion criteria: \n\n The following patients will be eligible for study participation: \n\n Patients with either type 1 or type 2 diabetes. Diabetes will be defined as those patients presently taking either oral hypoglycemic agents or insulin therapy (oral hypoglycemic agents to include all drugs in the drug classes of: alpha-glucosidase inhibitors, biguanides, meglitinides, sulfonylureas, thiazolidinediones and adjunctive therapy) taken for >6 months to rule-out steroid-induced diabetes and gestational diabetes. \n\n ", - "exclusion_criteria": ": \n\n Patients will be excluded from the study if they: \n\n Do not provide or are unable to provide written informed consent \n\n Refuse or are unlikely to attend follow-up visits for BP measurements \n\n Are institutionalized \n\n Are <18 years of age \n\n Do not understand English \n\n Enrolled in other diabetes or hypertension trials \n\n Subjects will be recruited whether or not they are receiving antihypertensive therapy.", - "brief_summary": "About 22% of Canadians have high blood pressure, or hypertension. However, studies have shown that only 1 out of 5 people with hypertension have their blood pressure controlled.~Diabetes is also an important risk factor for heart disease and stroke. About half of people with diabetes also have hypertension - a deadly combination. Studies have shown that only about 1 in 10 people with diabetes have their blood pressure controlled adequately - clearly something needs to be done to improve this.~Heart disease, stroke, hypertension, and diabetes are conditions that occur in the community, so we need to explore innovative solutions that will work in the community. Pharmacists are well-placed in the community to help identify people with diabetes and hypertension. This has worked very well in previous studies in patients with high cholesterol levels. Pharmacists and nurses have complementary skills which, when working as a team, may help identify and better manage hypertension in people with diabetes.~Our main objective is to test whether a community pharmacist and nurse team can improve blood pressure control in people with diabetes and hypertension.", - "NCTID": "NCT00374270" - }, - { - "brief_title": "Local Versus Systemic Thrombolysis for Acute Ischemic Stroke (SYNTHESIS)", - "phase": "Phase 3", - "drugs": "['local interarterial recombinant tissue plasminogen activator', 'intravenous (IV) rt-PA']", - "drugs_list": [ - "local interarterial recombinant tissue plasminogen activator", - "intravenous (IV) rt-PA" - ], - "diseases": "['Stroke', 'Cerebrovascular Accident']", - "diseases_list": [ - "Stroke", - "Cerebrovascular Accident" - ], - "enrollment": "54.0", - "inclusion_criteria": "inclusion criteria: \n\n Sudden focal neurological deficit attributable to a stroke \n\n Clearly defined time of onset, allowing initiation of intravenous treatment within 3 hours of symptoms onset and intra-arterial treatment within 6 hour of symptoms onset. \n\n Age between 18 and 80 years \n\n ", - "exclusion_criteria": ": \n\n Disability preceding stroke consistent with a modified Rankin scale score of 2-4 (see glossary for Rankin scale) \n\n Coma at onset \n\n Severe stroke as assessed clinically (e.g. NIHSS>25) \n\n Rapidly improving neurological deficit or minor symptoms \n\n Seizure at onset of stroke \n\n Clinical presentation suggestive of a subarachnoid hemorrhage (even of CT scan is normal) or condition after subarachnoid hemorrhage from aneurysm \n\n Previous history of or suspected intracranial hemorrhage \n\n Previous history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) \n\n Septic embolism, bacterial endocarditis, pericarditis \n\n Acute pancreatitis \n\n Arterial puncture at a non compressible site (e.g. subclavian or jugular vein puncture) or traumatic external heart massage or obstetrical delivery within the previous 10 days \n\n Another stroke or serious head trauma within the preceding 3 months \n\n Major surgery or significant trauma in past 3 month \n\n Urinary tract hemorrhage within the previous 21 days \n\n Documented ulcerative gastrointestinal disease during the last 3 months, esophageal varices, arterial-aneurysm, arterial/venous malformations \u2022 Neoplasm with increased bleeding risk \n\n Severe liver disease, including hepatic failure, cirrhosis, portal hypertension (esophageal varices) and active hepatitis \n\n Current therapy with intravenous or subcutaneous heparin or oral anticoagulants (e.g. warfarin sodium) to rise the clotting time \n\n Known hereditary or acquired hemorrhagic diathesis, baseline INR greater than 1.5, aPTT more than 1.5 times normal, or baseline platelet count less than 100,000 per cubic millimeter \n\n Baseline blood glucose concentrations below 50 mg per deciliter (2.75 mm/L) or above 400 mg per deciliter \n\n Hemorrhagic retinopathy, e.g. in diabetes (vision disturbances may indicate hemorrhagic retinopathy) \n\n Any history of prior stroke and concomitant diabetes \n\n Prior stroke within the last 3 months \n\n Known contrast sensitivity \n\n Severe uncontrolled hypertension defined by a blood pressure \u2265 185 mmHg systolic or diastolic \u2265 110 mm Hg in 3 separate occasions at least 10 minutes apart or requiring continuous IV therapy \n\n Prognosis very poor regardless of therapy; likely to be dead within months. \n\n Unlikely to be available for follow-up (e.g., no fixed home address, visitor from overseas).Any other condition which local investigators feels would pose a significant hazard in terms of risk/benefit to the patient, or if therapies are impracticable. \n\n Computed tomographic (CT) scan ", - "brief_summary": "The purpose of this study is to determine whether intra-arterial rt-PA within 6 hours from an ischemic stroke onset, compared with intravenous infusion of the same drug within 3 hours, increases the proportion of independent survivors at 3 months.", - "NCTID": "NCT00540527" - }, - { - "brief_title": "Mobile Stroke-Unit for Reduction of the Response Time in Ischemic Stroke", - "phase": "", - "drugs": "['MSU', 'OCCM']", - "drugs_list": [ - "MSU", - "OCCM" - ], - "diseases": "['Stroke']", - "diseases_list": [ - "Stroke" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Age between 18 and 80 years \n\n Onset of symptoms until call at least 30 min prior to the end of the approved time window for thrombolysis (and not after awakening) \n\n Clinical signs of ischemic stroke with suddenly occurring, measurable neurological deficits defined as impairment of language, motor function, facial palsy or asymmetry \n\n Patient is willing to participate voluntarily and to sign a written informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relative. \n\n Patients who are unable to sign but who are able to understand the meaning of participation in the study may give an oral witnessed informed consent. These patients have to make undoubtfully clear that they are willing to participate voluntarily and must be able to understand an explanation of the contents of the information sheet. \n\n ", - "exclusion_criteria": ": \n\n Age younger than 18 or older than 80 years \n\n Non-acute onset of symptoms \n\n No focal stroke-like symptoms \n\n Pregnant patients", - "brief_summary": "Stroke, the most common cause of permanent disability, the second most common cause of dementia and third most common cause of death, has tremendous socio-economic consequences.~Currently, systemic thrombolysis with the tissue plasminogen activator represents the only causal and approved treatment for acute ischemic stroke. However, the chances to save the brain tissue by a thrombolytic therapy exponentially decrease with proceeding time after onset of symptoms.~In most cases, the beginning of the thrombolysis therapy is delayed by a variety of factors, like delivery to the hospital, re-examinations and delay of blood analysis or of CT scans. Due to this, a thrombolytic therapy is possible only in a minority of the stroke patients (2-5 %). The aim of this study is to investigate whether a Mobile Stroke Unit, a rescue car with an integrated CT scanner, necessary for essential diagnostics, contributes to a better stroke management by saving precious time until a therapeutic decision is made. The trial is planned as a monocentric, randomised prospective trial.", - "NCTID": "NCT00792220" - }, - { - "brief_title": "Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin\u00ae in Acute Ischemic Hemispheric Stroke", - "phase": "Phase 3", - "drugs": "['Cerebrolysin', '0.9% Saline Solution']", - "drugs_list": [ - "Cerebrolysin", - "0.9% Saline Solution" - ], - "diseases": "['Stroke']", - "diseases_list": [ - "Stroke" - ], - "enrollment": "119.0", - "inclusion_criteria": "inclusion criteria: \n\n Female or male inpatients. \n\n Age: 18-80 years. \n\n If female, patient must not be pregnant \n\n Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze,vision or neglect. Ischemic stroke is defined as an event characterized by the sudden onset of an acute focal neurologic deficit presumed to be due to cerebral ischemia after CT scan excludes haemorrhage. \n\n Onset of symptoms within 3 hours prior to initiation of rt-PA administration. \n\n Stroke symptoms are to be present for at least 30 minutes and have not significantly improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure or migraine disorder. \n\n Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable, according to the regulatory and legal requirements of the participating country. \n\n Patients who are unable to sign but who are able to understand the meaning of participation in the study may give an oral witnessed informed consent. These patients have to make clear undoubtful that they are willing to participate voluntarily and must be able to understand an explanation of the contents of the information sheet. A written consent has to be obtained as soon as possible. \n\n Willingness and ability to comply with the protocol. \n\n ", - "exclusion_criteria": ": \n\n Evidence of intracranial haemorrhage (ICH) on the CT-scan \n\n Violation of inclusion criteria not approved by clinical study director or study safety officer \n\n Failure to perform or to evaluate screening or baseline examinations \n\n Hospitalisation (except for study purposes) or change of concomitant medication 4 weeks prior to screening or during screening period \n\n Participation in another therapeutic clinical trial 3 months before baseline \n\n Patients with any history of prior stroke and concomitant diabetes \n\n Prior stroke within the last 3 months \n\n Platelet count of below 100x103/mm3 \n\n Blood glucose <50 or >400 mg/dl (<2.77 or >22.15 mmol/L) \n\n Known haemorrhagic diathesis \n\n Manifest or recent severe or dangerous bleeding \n\n Known bacterial endocarditis, pericarditis \n\n Acute pancreatitis \n\n Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial-aneurysm, arterial/venous malformation \n\n Neoplasm with increased bleeding risk \n\n Severe liver disease, including hepatic failure, cirrhosis, portal hypertension, oesaphageal varices) and active hepatitis \n\n Major surgery or significant trauma in past 3 months \n\n Lab values seriously abnormal, and/or more than 2 lab values abnormal not approved by clinical study director or study safety officer \n\n Serious drug allergies \n\n Hypersensitivity to one of the components of the drug \n\n Severe renal impairment \n\n Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, or aggressive management (IV medication) necessary to reduce BP to these limits \n\n Recent (less than 10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture) \n\n Chronic intoxication or chronic substance use disorder with pharmaceuticals, drugs, alcohol or industrial poisons \n\n Symptoms of ischemic attack began more than 3 hours prior to start of thrombolytic therapy or if time of symptom onset is unknown \n\n Minor neurological deficit or symptoms rapidly improving before start of infusion \n\n Severe stroke as assessed clinically (e.g. NIHSS >25) and/or by appropriate imaging techniques \n\n Epilepsy or epileptic seizure at onset of stroke \n\n Symptoms suggestive of subarachnoid haemorrhage, even if the CT-scan is normal \n\n Known history of or suspected intracranial haemorrhage \n\n Suspected subarachnoid haemorrhage or condition after subarachnoid hemorrhage from aneurysm \n\n Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) \n\n Haemorrhagic retinopathy, e.g. in diabetes (vision disturbances may indicate haemorrhagic retinopathy) \n\n Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory \n\n Patients receiving oral anticoagulants, e.g. warfarin sodium \n\n Special attention should be given to possible additive effects when used in conjunction with anti-depressants or MAO-inhibitors \n\n Cerebrolysin should not be mixed with balanced amino acid solutions in an infusion", - "brief_summary": "It should be shown that Cerebrolysin in combination with Alteplase, the medication that should recover the blood flow through the brain, is an effective and save medication to treat ischeamic stroke.", - "NCTID": "NCT00840671" - }, - { - "brief_title": "Atrial Fibrillation Detected by Continuous ECG Monitoring", - "phase": "", - "drugs": "['Implantable loop recorder (Medtronic Reveal LINQ(TM))']", - "drugs_list": [ - "Implantable loop recorder (Medtronic Reveal LINQ(TM))" - ], - "diseases": "['Atrial Fibrillation', 'Stroke', 'Hypertension', 'Diabetes']", - "diseases_list": [ - "Atrial Fibrillation", - "Stroke", - "Hypertension", - "Diabetes" - ], - "enrollment": "6000.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 70-90 years, and \n\n Previously diagnosed with \u22651 of: \n\n Diabetes mellitus (type 1 or type 2, with or without medical therapy) \n\n Hypertension (with or without medical therapy) \n\n Heart failure \n\n Previous diagnosed stroke (previous transient ischemic attack is not considered an inclusion criterion) \n\n ", - "exclusion_criteria": ": \n\n History of atrial fibrillation or flutter irrespective of type \n\n Cardiac pacemaker or defibrillator (with or without re-synchronization therapy) \n\n Contraindication to oral anticoagulation therapy \n\n Anticoagulation therapy; vitamin K antagonists, direct oral anticoagulants, or (low-molecular) heparins. Therapy with platelet inhibitors such as acetyl-salicylic acid, clopidogrel, persantine is not considered an exclusion criterion \n\n Renal failure treated with permanent dialysis \n\n Uncorrected congenital heart disease, or severe valvular stenosis, obstructive cardiomyopathy, active myocarditis, or constrictive pericarditis. \n\n On a waiting list for major surgery (cardiac, thoracic or abdominal) \n\n Cardiac or thoracic surgery has been performed within 3 months from inclusion \n\n Any major organ transplant (e.g. lung, liver, heart, or kidney) \n\n Cytotoxic or cytostatic chemotherapy and/or radiation therapy for treatment of a malignancy within 6 months before randomization or clinical evidence of current malignancy with the following exceptions: Basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if stable, localized disease with a life expectancy of > 2.5 years in the opinion of the investigator) \n\n Life-expectancy shorter than 6 months \n\n Known to be human immunodeficiency virus (HIV) positive with an expected survival of less than 5 years due to HIV infection \n\n Recent (within 3 months) history of alcohol or drug abuse based on self-reporting \n\n Any condition (e.g. psychiatric illness, dementia) or situation, that in the investigators opinion could put the subject at significant risk, confound the study results, or interfere significantly with the subject participation in the study \n\n Unwillingness to participate or patient does not understand Danish language", - "brief_summary": "The LOOP study aims to determine whether screening for atrial fibrillation (AF) with implantable loop recorder and initiation of oral anticoagulation (OAC) if AF is detected will reduce the risk of stroke and systemic arterial embolism in patients with risk factors for stroke.", - "NCTID": "NCT02036450" - }, - { - "brief_title": "ReoPro and Retavase to Restore Brain Blood Flow After Stroke", - "phase": "Phase 2", - "drugs": "['Abciximab (ReoPro) and Reteplase (Retavase)']", - "drugs_list": [ - "Abciximab (ReoPro) and Reteplase (Retavase)" - ], - "diseases": "['Cerebrovascular Accident']", - "diseases_list": [ - "Cerebrovascular Accident" - ], - "enrollment": "42.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients may be enrolled in the study only if they meet all of the following criteria: \n\n Diagnosis of acute ischemic stroke with onset between 3 and 24 hours prior to planned start of study drugs. Acute ischemic stroke is defined as a measurable neurological deficit of sudden onset, presumed secondary to focal cerebral ischemia, and not otherwise attributable to ICH or another disease process. Stroke onset will be defined as the time the patient was last known to be without the new clinical deficit. Patients whose deficits have worsened in the last 24 hours are not eligible if their first symptoms started more than 24 hours before. If the stroke started during sleep, stroke onset will be recorded as the time the patient was last known to be intact. A careful history is important to determine when the patient was last without the presenting deficits. \n\n Disabling neurological deficit attributable to the acute stroke at the start of study drugs. \n\n NIHSS less than or equal to 16. \n\n Evidence on PWI MRI of a perfusion defect corresponding to the acute stroke syndrome of at least 2cm in diameter in both long and short axis in any slice. The PWI will be assessed by relative mean transit time (MTT) images. The MRI evaluation must involve echo planar diffusion weighted imaging, MRA, and MRI perfusion. A normal appearing MRA with an appropriate perfusion defect is eligible. An apparent stenosis or occlusion on MRA with normal appearing perfusion distally will not be eligible. Poor quality or uninterpretable MRA will not make patient ineligible. Patients who have a normal DWI are eligible. \n\n Age 18 - 80 years, inclusive. \n\n ", - "exclusion_criteria": ": \n\n Patients will be excluded from the study for any of the following reasons: \n\n General: \n\n Current participation in another study with an investigational drug or device within, prior participation in the present study, or planned participation in another therapeutic trial, prior to the final assessment in this trial. \n\n Time interval since stroke onset of less than 24 hours impossible to determine with high degree of confidence. \n\n Symptoms suggestive of subarachnoid hemorrhage, even if CT or MRI scan is negative for hemorrhage. \n\n Evidence of acute myocardial infarction defined as having at least two of the following three features: 1.) Chest pain suggestive of cardiac ischemia; 2.) EKG findings of ST elevation of greater than 0.2 mV in 2 contiguous leads, new onset left bundle branch block, ST segment depression, or T-wave inversion; 3.) Elevated troponin I \n\n Contraindication to MRI scan. \n\n Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test. \n\n Patients who would refuse blood transfusions if medically indicated. \n\n Stroke Related: \n\n Neurological deficit that has led to stupor or coma (NIHSS level of consciousness score greater than or equal to 2). \n\n High clinical suspicion of septic embolus. \n\n Minor stroke with non-disabling deficit or rapidly improving neurological symptoms. \n\n Baseline NIHSS greater than 16. \n\n MRI/CT Related: \n\n Evidence of acute or chronic ICH by head CT or MRI. \n\n Evidence of microbleed on gradient echo MRI (GRE). \n\n CT or MRI evidence of non-vascular cause for the neurological symptoms. \n\n Signs of mass effect causing shift of midline structures. \n\n Incomplete or uninterpretable DWI and PWI. \n\n DWI abnormality larger than approximately one third of the territory of the middle cerebral artery territory by qualitative assessment. \n\n Satellite DWI hyperintensity with corresponding hyperintensity on T2 weighted image or FLAIR in a vascular territory different than the index stroke (this is evidence of a new ischemic lesion possibly greater than 24 hours in duration). \n\n Safety Related: \n\n Persistent hypertension with systolic BP greater than 185 mmHg or diastolic BP greater than 110 mmHg (mean of 3 consecutive arm cuff readings over 20-30 minutes), not controlled by antihypertensive therapy or requiring nitroprusside for control. \n\n Anticipated need for major surgery within 72 hours after start of study drugs, e.g., carotid endarterectomy, hip fracture repair. \n\n Any intracranial surgery, serious head trauma (any head injury that required hospitalization), within the past 3 months. \n\n Stroke within the past 3 months. \n\n History of ICH at any time in the past. \n\n Major trauma at the time of stroke, e.g., hip fracture. \n\n Blood glucose greater than 200 mg/dl. \n\n Presence or history of intracranial neoplasm (except small meningiomas) or arteriovenous malformation. \n\n Intracranial aneurysm, unless surgically treated greater than 3 months. \n\n Major hemorrhage in past 21 days. \n\n Major surgery, serious trauma, lumbar puncture, arterial puncture at a non-compressible site, or biopsy of a parenchymal organ in last 14 days. Major surgical procedures include but are not limited to the following: major thoracic or abdominopelvic surgery, neurosurgery, major limb surgery, carotid endarterectomy or other vascular surgery, and organ transplant. For non-listed procedures, the operating surgeon should be consulted to assess the risk. \n\n Presumed or documented history of vasculitis. \n\n Known systemic bleeding disorder, e.g., von Willebrand's disease, hemophilia, others. \n\n Platelet count less than 100,000 cells/microL. \n\n Congenital or acquired coagulopathy (e.g. secondary to anticoagulants causing either of the following: \n\n Activated partial thromboplastin time (aPPT) prolongation greater than 2 seconds above the upper limit of normal for local laboratory, except if due to isolated factor XII deficiency. Protamine sulfate reversal of heparin effect does not alleviate this criterion. \n\n INR greater than or equal to 1.4. Patients receiving warfarin prior to entry are eligible provided INR is less than 1.4 and warfarin can be safely discontinued for at least 48 hours. \n\n Potentially Interfering with Outcome Assessment: \n\n Life expectancy less than 3 months. \n\n Other serious illness, e.g., severe hepatic, cardiac, or renal failure; acute myocardial infarction; or a complex disease that may confound treatment assessment. \n\n Serum creatinine, AST or ALT greater than 3 times the upper limit of normal for the local laboratory. \n\n Drug Related: \n\n Treatment of the qualifying stroke with any thrombolytic or GPIIbIIIa inhibitor outside of this protocol. \n\n Any administration of a thrombolytic drug in the prior 7 days. \n\n Treatment of the qualifying stroke with intravenous heparin unless aPTT prolongation is no greater than 2 seconds above the upper limit of normal for local laboratory prior to study drug initiation. \n\n Treatment of the qualifying stroke with a low molecular weight heparinoid. \n\n Previous administration of abciximab, if known. \n\n Known allergy to murine proteins. \n\n Anticoagulation (evidenced by PT, PTT, or platelet count) caused by herbal therapy.", - "brief_summary": "This study will evaluate the safety and effectiveness of two types of blood thinners, abciximab (ReoPro) and reteplase (Retavase) for restoring normal brain blood flow after ischemic stroke (stroke resulting from a blood clot in the brain).~The only therapy approved by the Food and Drug Administration to treat ischemic stroke is the clot buster drug rt-PA. This treatment, however, is effective only if begun within 3 hours of onset of the stroke and most patients do not get to the hospital early enough to benefit from it. There is thus a pressing need to develop effective stroke treatments that can be initiated more than 3 hours after onset.~Patients between 18 and 80 years of age who have experienced a mild or moderate acute stroke between 3 and 24 hours before starting study drugs may be eligible for this study. Candidates will be screened with a physical examination, blood tests and a magnetic resonance imaging (MRI) scan (if an MRI was not done during the stroke evaluation).~All participants will receive ReoPro. Some will also receive Retavase, which may boost the effectiveness of ReoPro. Retavase is administered in a single dose through a needle in the vein over 2 minutes. ReoPro is infused into the vein over 12 hours. Patients will be monitored with physical examinations, blood tests, computed tomography (CT) scans, and three or four MRI scans of the brain to evaluate both the response to treatment and side effects of the drugs. An MRI scan will be done 24 hours, 5 days and 30 days after starting the study medication, and possibly during screening for this study.~CT involves the use of specialized x-rays to obtain images of the brain. The patient lies still in the scanner for a short time while the X-ray images are formed. MRI uses a strong magnetic field and radio waves to demonstrate structural and chemical changes in tissue. MRI is more sensitive than x-ray in evaluating acute stroke. The patient lies on a table in a metal cylinder (the scanner) while the pictures are being taken. During part of the MRI, a medicine called gadolinium contrast is injected in a vein. This medicine brightens the images, creating better pictures of the blood flow.", - "NCTID": "NCT00039832" - }, - { - "brief_title": "Effect of GlucoNorm vs Glyburide on Post-Prandial Hyperglycemia in Elderly Subjects With Type 2 Diabetes", - "phase": "Phase 2", - "drugs": "['glyburide', 'GlucoNorm']", - "drugs_list": [ - "glyburide", - "GlucoNorm" - ], - "diseases": "['Type 2 Diabetes']", - "diseases_list": [ - "Type 2 Diabetes" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Type 2 diabetes > 3 months duration \n\n Male or female \n\n Over 65 years of age \n\n Diet controlled only \n\n HgbA1C < 8.5% \n\n ", - "exclusion_criteria": ": \n\n Treatment with oral hypoglycemic agents or insulin or the likelihood of requiring treatment with these during the study. \n\n Anemia - hgb below 130 g/L (males) and below 120 g/L (females). \n\n Taking medications that known to interfere with glucose metabolism eg systemic corticosteriods, non-selective beta blockers. \n\n Known or suspected allergy to glyburide, sulfa drugs or GlucoNorm impaired liver function, as shown by but not limited to AST and/or ALT > 2x the upper limit of normal. \n\n Impaired renal function, as shown by but not limited to serum creatinine > 133 \u00b5mol/L (males) or 124 \u00b5mol/L (females). \n\n Participated in another clinical trial within the past 30 days.", - "brief_summary": "The results from the DECODE Study have shown that postprandial (1 - 2 hours after a meal) hyperglycemia (elevated blood sugar) is more common in elderly people with diabetes than younger people with diabetes and is the best predictor of the development of complications. The DECODE Study involved 6941 people who already had diabetes and 702 who did not have diabetes. Diabetes is diagnosed when the blood sugar 1st thing in the morning is over 7.0 mmol/L. The DECODE Study showed that people at risk for diabetes can have a normal blood sugar 1st thing in the morning but have a high blood sugar 2 hours after a meal and that these people are at risk for developing heart disease and other complications of diabetes. These people would not be identified as at risk if only a fasting blood sugar is done. Studies in younger people with diabetes have shown that after a meal, insulin levels are more like a person without diabetes and glucose (blood sugar) levels are lower with GlucoNorm than with Glyburide. There is no data available that demonstrates this in elderly people with type 2 diabetes.~You have been invited to participate in this study because you have type 2 diabetes controlled by diet and/or exercise or metformin only and are over 65 years of age.~The purpose of this study is to determine whether GlucoNorm has a greater effect than Glyburide on insulin levels and glucose (blood sugar) levels after a meal in elderly people with type 2 diabetes who control their diabetes with diet and exercise.", - "NCTID": "NCT00451620" - }, - { - "brief_title": "PREdicting Atrial Fibrillation or Flutter", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Atrial Fibrillation', 'Atrial Flutter']", - "diseases_list": [ - "Atrial Fibrillation", - "Atrial Flutter" - ], - "enrollment": "360.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient meets the approved FDA indication to receive the ICM \n\n Patient is suspected, based on demographics, to be at high risk of having AF, as determined by the clinical investigator \n\n Patient has a CHA2DS2-VASc score \u2265 2 [Note: stroke/TIA criterion as part of the CHA2DS2-VASc score for this trial is limited to either an ischemic stroke or TIA, which occurred more than one year prior to enrollment.] \n\n Patient is 18 years of age or older \n\n Patient has a life expectancy of 18 months or more \n\n ", - "exclusion_criteria": ": \n\n Patient has a documented history of AF or atrial flutter \n\n Patient has a symptom complex consistent with an arrhythmia (where an ICM may have an alternate indication for use) \n\n Patient had an ischemic stroke or TIA within past year prior to enrollment \n\n Patient has a history of a hemorrhagic stroke \n\n Patient is currently implanted with a permanent pacemaker, insertable loop recorder, implantable defibrillator, cardiac resynchronization therapy device (pacemaker or defibrillator) \n\n NYHA Class IV Heart Failure patient \n\n Patient had heart surgery within previous 90 days prior to enrollment \n\n Patient had an MI within the previous 90 days prior to enrollment \n\n Patient is taking chronic immunosuppressant therapy \n\n Patient is taking an anti-arrhythmic drug \n\n Patient is contraindicated for long term anticoagulation medication \n\n Patient is taking a long-term anticoagulation medication \n\n Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional / psychological diagnosis) \n\n Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from the principal investigator \n\n Patient has a creatinine clearance <30 ml/min or is on dialysis \n\n Active pregnancy", - "brief_summary": "The purpose of this study is to determine, through continuous monitoring with a cardiac monitoring device placed under the skin, the incidence of atrial fibrillation or flutter (AF). The cardiac monitor will be placed in patients without symptoms but at risk for AF. It is hoped that this information may assist health care professionals in treatment decisions related to the early identification of patients at high risk for AF.", - "NCTID": "NCT01851902" - }, - { - "brief_title": "Orthostatic Hypotension and Diabetes Mellitus", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Orthostatic Hypotension', 'Diabetes Mellitus Type 2']", - "diseases_list": [ - "Orthostatic Hypotension", - "Diabetes Mellitus Type 2" - ], - "enrollment": "500.0", - "inclusion_criteria": "inclusion criteria: \n\n diabetes mellitus \n\n age (70 years and older) \n\n ", - "exclusion_criteria": ": \n\n Known autonomic dysfunction \n\n Neurodegenerative diseases \n\n Current malignancy \n\n Living in a nursing-home \n\n Irregular pulse", - "brief_summary": "Rationale: Orthostatic hypotension increases with age and is associated with increased vascular and all-cause mortality. The prevalence of orthostatic hypotension is also increased in diabetic subjects. In order to prevent related adverse events and vascular mortality it is of great interest to examine the prevalence of orthostatic hypotension in elderly diabetic subjects.~Objective: To examine the prevalence of orthostatic hypotension and associated adverse events in type 2 diabetic elderly subjects.~Study design: Cross-sectional observational study.~Study population: Elderly type 2 diabetic subjects (70 years and older).", - "NCTID": "NCT00807976" - }, - { - "brief_title": "Essential Hypotension and Allostasis Registry", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Fibromyalgia', 'Blood Pressure', 'Depression', 'Panic Attack', 'POTS', 'Inappropriate Sinus Tachycardia', 'Coronary Heart Disease', 'Acute Coronary Syndrome (ACS)', 'Acute Myocardial Infarction (AMI)', 'Cerebrovascular Disease (CVD)', 'Transient Ischemic Attack (TIA)', 'Atrial Fibrillation', 'Diabetes Mellitus', 'Cancer', 'Systolic Heart Failure', 'Diastolic Heart Failure', 'Chronic Fatigue Syndrome', 'Syncope', 'Vasovagal Syncope']", - "diseases_list": [ - "Fibromyalgia", - "Blood Pressure", - "Depression", - "Panic Attack", - "POTS", - "Inappropriate Sinus Tachycardia", - "Coronary Heart Disease", - "Acute Coronary Syndrome (ACS)", - "Acute Myocardial Infarction (AMI)", - "Cerebrovascular Disease (CVD)", - "Transient Ischemic Attack (TIA)", - "Atrial Fibrillation", - "Diabetes Mellitus", - "Cancer", - "Systolic Heart Failure", - "Diastolic Heart Failure", - "Chronic Fatigue Syndrome", - "Syncope", - "Vasovagal Syncope" - ], - "enrollment": "5000.0", - "inclusion_criteria": "inclusion criteria: \n\n Any patient regardless of the age of gender \n\n ", - "exclusion_criteria": ": \n\n Any non-correctable secondary cause of increase or decrease in blood pressure \n\n or a pathology that alters the prognosis before the entrance of the patient into this registry. \n\n nephropathy prior to the admission, \n\n familial dyslipidemia, \n\n previous gastric bypass, \n\n pre-existing heart failure, \n\n chemotherapy-induced cardiotoxicity, \n\n arrhythmogenic right ventricular dysplasia, \n\n long QT syndrome, \n\n hypertrophic cardiomyopathy \n\n restrictive cardiomyopathy or sudden death syndromes other than coronary disease \n\n Down syndrome, \n\n having one single kidney before entering to this registry, \n\n polycystic kidney, \n\n disability to continue with the treatment \n\n organ transplantation (other than cornea), \n\n HIV positive, \n\n homocystinuria, \n\n myelomeningocele, \n\n autoimmune diseases, \n\n paraplegia, \n\n chronic infections (TB), \n\n myocarditis of any cause, \n\n blood dyscrasia with coagulation disorders, \n\n history of pulmonary embolism, \n\n sustained or non-sustained ventricular tachycardia, \n\n idiopathic tachycardia associated with syncope which is not cured by radiofrequency ablation, \n\n pulmonary hypertension, \n\n diabetes insipidus, \n\n COPD, \n\n Gitelman syndrome, \n\n Cervical cancer associated with human Papillomavirus, \n\n multiple sclerosis, \n\n hemochromatosis, \n\n not compact ventricle. \n\n It is important to emphasize that all of these patients, currently excluded from the registry, may be studied in the future, they keep on follow-up and taken 6 BP. \n\n Additionally it is planned to compare the evolution of patients with secondary causes of hypertension or hypotension with essential disorders", - "brief_summary": "The essential arterial hypotension and allostasis registry is a prospective, observational research that has the purpose of demonstrating that essential blood pressure (BP) disorders and the associated comorbidities are a result of the inappropriate allostatic response to daily life stress. This required a functioning brain orchestrating the evaluation of the threat and choosing the response, this is a mind-mediated phenomenon. If the response is excessive it contributes to high BP, if deficient to low BP, and the BP itself will identify the allostatic pattern, which in turn will play an important role in the development of the comorbidities.~To do so, consecutive patients of any age and gender that visit a cardiologist's office in Medellin, Colombia, are recruited. Individuals are classified according to their arterial BP and allostasis and follow them in time to see what kind of diseases develops the most (including BP) in the follow up according to the categorization of the characteristic chosen and after adjustment for confounder's variables. In addition, stress events with their date are registered.~HYPOTHESIS~The causes of the diseases are multifactorial.~Physical, biochemical, psychological, social, and cultural dimensions of development dynamically interact to shape the health development process.~A person\u00b4s health depends on their:~Biological and physiologic systems~External and internal environment (a) physical, b) internal behavioural and arousal state as registered by the brain.~Their interaction.~The allostatic mechanisms to the internal and external stressors (allostatic load) involves a network composed by:~Functional systems; mediated by:~The Autonomic Nervous System~The endocrine system~The immune system~Structural changes: whenever the internal and/or external stressors are long lasting and/or strength enough, they may induce changes in:~Epigenetic, endophenotypes, polyphenism.~Plasticity~The interaction between a) and b).~The network response do not affect exclusively the BP, propitiating the development of comorbidities, which may prompt strategies for prevention, recognition and ultimately, treatment.~The allostatic model defines health as a state of responsiveness.~The concept of psycho-biotype: The allostasis is the result of both: biological (allostasis) and psychological (psychostasis) abilities. It is proposed that both components behave in similar direction and magnitude.~Immune disorders may be associated with the development of cancer. High BP population has a higher sympathetic and lower vagal tone, this has been associated with a decrease in the immune\u00b4s system function.~Resources and energy depletion: Terms like weathering have been used to describe how exposures to different allostatic loads gradually scrape away at the protective coating that keeps people healthy. It is postulated that High BP individuals have more resources and energy.", - "NCTID": "NCT02018497" - }, - { - "brief_title": "Cyclosporine A to Treat Hypertrophic Cardiomyopathy (HCM)", - "phase": "Phase 2", - "drugs": "['Cyclosporine A']", - "drugs_list": [ - "Cyclosporine A" - ], - "diseases": "['Cardiomyopathy, Hypertrophic', 'Heart Hypertrophy']", - "diseases_list": [ - "Cardiomyopathy", - "Hypertrophic", - "Heart Hypertrophy" - ], - "enrollment": "32.0", - "inclusion_criteria": "Patients of either gender, aged 18-75 years, with HCM caused by sarcomeric gene mutations determined by existing protocols. \n\n LV wall thickness of greater than or equal to 20 mm measured in any LV segment by MRI. \n\n Severe symptoms refractory to medical treatment (New York Heart Association functional class III or IV). \n\n No LV outflow tract obstruction at rest greater than 30 mm Hg as determined by cardiac catheterization. \n\n No coronary artery disease (greater than 50% arterial luminal narrowing of a major epicardial vessel). \n\n No chronic atrial fibrillation. \n\n No bleeding disorder (PTT greater than 35 sec, pro time greater than 14 sec, platelet count less than 154 k/mm(3). \n\n No anemia (Hb less than 12.7 g/dl in males and less than 11.0 g/dl in females). \n\n No renal impairment (serum creatinine greater than 1.3 mg/dl). \n\n No hepatitis B or C; nor unexplained abnormal LFTs. \n\n No inability to estimate LV wall thickness. \n\n No positive urine pregnancy test. \n\n No pregnant or lactating female patients. \n\n No concurrent use of immunosuppressives or steroids. \n\n No diabetes mellitus. \n\n No history of malignancy other than skin tumors (squamous and basal cell) in the last 5 years. \n\n No condition that excludes the patient from undergoing an MRI test.", - "exclusion_criteria": "", - "brief_summary": "This study will examine the effectiveness of the drug cyclosporine in treating hypertrophic cardiomyopathy (HCM), a condition in which the heart muscle thickens. The thickened muscle can impair the heart's pumping action or decrease its blood supply, or both. Various symptoms, such as chest pain, shortness of breath, fatigue, and palpitations, may result. In animal studies, cyclosporine prevented heart muscle from thickening in mice that had been engineered to develop thick hearts.~Patients with HCM 18 to 75 years old are screened for this study under protocol 98-H-0102 and this protocol. Screening tests include blood tests, echocardiogram to measure heart thickness, Holter monitor to record heartbeats, treadmill exercise test, and various imaging tests including a thallium scan, radionuclide angiography, magnetic resonance imaging (MRI), and cardiac catheterization to examine heart function and blood supply.~Patients admitted to the study will be randomly assigned to take either cyclosporine tablets or a placebo (a look-alike tablet with no active ingredient) twice a day for 6 months. During a brief hospital stay at the start of the study, blood samples will be taken to measure cyclosporine levels. After discharge, heart rate and blood pressure will be checked and blood tests done during follow-up visits once a week for 2 weeks and then every two weeks until the end of the 6-month treatment period. At that time, patients will be hospitalized a second time for repeat tests to determine the effects of the drug on the heart condition. They include thallium scan, radionuclide angiogram, MRI, treadmill exercise test, cardiac catheterization, and echocardiogram. An echocardiogram and MRI will be repeated 1 year after the start of the study to evaluate long term effects of the drug, if any.", - "NCTID": "NCT00001965" - }, - { - "brief_title": "Pilot Safety Study of Coronary CTA for the Diagnosis of Acute Coronary Syndrome in the Emergency Room", - "phase": "", - "drugs": "['computed coronary angiography', 'Exercise stress echocardiography']", - "drugs_list": [ - "computed coronary angiography", - "Exercise stress echocardiography" - ], - "diseases": "['Acute Coronary Syndrome', 'Coronary Artery Disease', 'Cardiac Death', 'Myocardial Infarction']", - "diseases_list": [ - "Acute Coronary Syndrome", - "Coronary Artery Disease", - "Cardiac Death", - "Myocardial Infarction" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient is in Sinus Rhythm \n\n Typical or atypical chest pain lasting more than 5 min in the last 24 hs. \n\n Estimated pre-test probability of significant coronary artery disease more than 15%. \n\n Absence of ECG changes suggestive of myocardial ischemia (ST-segment deviation >1 mm or T Wave inversion > 4 mm in at least two contiguous leads). \n\n Negative initial troponins I at admission (<0.05 ng/ml) \n\n ", - "exclusion_criteria": ": \n\n Known allergy to iodinated contrast. \n\n Known renal insufficiency or Creatinine >1.5 mg/dl at admission. \n\n History of known coronary artery disease or prior myocardial revascularization \n\n Any of the following:hemodynamic instability, persistent chest pain despite treatment, Systolic blood pressure <100 mm Hg. \n\n Cardiac arrhythmia with rapid or irregular ventricular response. \n\n Inability to perform an exercise test. \n\n Patient is incapable of providing informed consent.", - "brief_summary": "The Diagnosis of acute coronary syndrome in patients presenting with acute chest pain is problematic when both, electrocardiogram and serum troponins are normal. Multidetector row computed tomography angiography (CTA) allows direct and rapid non-invasive visualization of coronary artery disease.~The investigator's aim is to assess the diagnostic accuracy and safety of a novel diagnostic strategy based on MDCT as compared to a strategy using stress echocardiography in the workup of patient with chest pain, normal electrocardiogram, normal troponins and suspected coronary artery disease. Additionally, the cost associated with both strategies will be compared.~Methods. A total of 150 patients with acute chest pain coming to the emergency room with intermediate probability of significant coronary artery disease, normal ECG and troponins will be prospectively randomized to MDCT or stress echocardiography with exercise. Patients showing coronary stenosis >50% at MDCT or abnormal stress echocardiography or inconclusive results will be admitted for further study. The primary endpoint of the study is the detection of an acute coronary syndrome, defined as typical or atypical angina with documented significant coronary artery disease (>50% stenosis) on invasive coronariography, a positive stress test or the occurrence of cardiac death, myocardial infarction or need for revascularization during 6 month follow-up. All MDCT angiograms and echocardiograms will be evaluated by an experienced radiologist and cardiologist.", - "NCTID": "NCT01682096" - } - ], - "2": [ - { - "brief_title": "Cryptogenic Stroke Study", - "phase": "", - "drugs": "['Sleuth AT Implantable ECG Monitoring System']", - "drugs_list": [ - "Sleuth AT Implantable ECG Monitoring System" - ], - "diseases": "['Cryptogenic Stroke']", - "diseases_list": [ - "Cryptogenic Stroke" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Recent stroke (within 30 days) as defined by who has a sudden onset of focal neurological deficits presumed vascular etiology and lasting more than 24 hours. \n\n Negative brain image for hemorrhagic stroke \n\n In sinus rhythm at time of enrollment \n\n ", - "exclusion_criteria": ": \n\n Know history of atrial fibrillation \n\n Previous implanted cardiac device (ppM or ICD) \n\n Serious illness making it unlikely to survive one year \n\n Known secondary cause of stroke", - "brief_summary": "The purpose of this study is to determine whether the Sleuth Implantable Loop Recorder will enhance detection of latent atrial fibrillation in patients after cryptogenic stroke.", - "NCTID": "NCT00861133" - }, - { - "brief_title": "Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS)", - "phase": "", - "drugs": "['Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)']", - "drugs_list": [ - "Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)" - ], - "diseases": "['Stroke']", - "diseases_list": [ - "Stroke" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 18 years \n\n Seen at UCSF Medical Center for cryptogenic stroke or high-risk TIA \n\n Onset of stroke or TIA symptoms within the previous 60 days \n\n ", - "exclusion_criteria": ": \n\n Definite small-vessel etiology by history or imaging \n\n Source found on vascular imaging of possible culprit vessels \n\n Source found by echocardiography (TEE not required) \n\n History of atrial fibrillation \n\n Atrial fibrillation on admission ECG \n\n Atrial fibrillation detected by inpatient cardiac telemetry (at least 24 hours required) \n\n Obvious culpable systemic illness such as endocarditis \n\n Patient unable to provide written, informed consent", - "brief_summary": "Atrial fibrillation (AF) is a common and treatable cause of ischemic stroke, but it can be paroxysmal and asymptomatic, and therefore difficult to detect. Patients with stroke routinely undergo 24 hours of continuous cardiac telemetry during hospitalization for stroke as a means of excluding AF. Small studies indicate that extending the duration of monitoring with portable outpatient telemetry devices detects more cases of AF. However, these studies are small and lack control groups, and cannot demonstrate that prolonged cardiac monitoring detects more cases of AF than routine clinical follow-up. The investigators therefore propose a pilot study to determine the feasibility of randomizing patients to prolonged cardiac monitoring or routine clinical follow-up. The investigators will enroll 40 consecutive adult patients seen at the University of California at San Francisco (UCSF) Neurovascular service with cryptogenic stroke or high-risk TIA (ABCD2 score 4 or greater). Enrolled patients will be randomized in a 1:1 fashion. Group A will be assigned to wear an ambulatory cardiac event monitor for 21 days. Group B will be discharged home without a monitor and will serve as controls during routine clinical follow-up. The investigators' primary outcome will be feasibility, defined as more than 80% of randomized patients completing full clinical follow-up and more than 70% of cardiac monitoring if applicable. The investigators' secondary outcomes will be diagnoses of AF at 90 days and 1 year and diagnoses of recurrent stroke at 1 year.", - "NCTID": "NCT00932425" - }, - { - "brief_title": "Patent Foramen Ovale in Cryptogenic Stroke Study", - "phase": "Phase 4", - "drugs": "['Warfarin', 'Aspirin']", - "drugs_list": [ - "Warfarin", - "Aspirin" - ], - "diseases": "['Ischemic Stroke', 'Patent Foramen Ovale']", - "diseases_list": [ - "Ischemic Stroke", - "Patent Foramen Ovale" - ], - "enrollment": "630.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 30-85 \n\n Ischemic stroke within 30 days \n\n Glasgow outcome scale \u2265 3 \n\n No contraindications to warfarin/aspirin \n\n ", - "exclusion_criteria": ": \n\n Basal INR > 1.4 \n\n Post-procedural stroke \n\n Severe carotid atherosclerosis \n\n Cardioembolic stroke \n\n Contraindications to transesophageal echocardiography", - "brief_summary": "The study sought to assess the rate of recurrent stroke and death in stroke patients with a patent foramen ovale randomized to treatment with warfarin or aspirin. This was a multicenter study conducted at 48 U.S. Institutions.", - "NCTID": "NCT00697151" - }, - { - "brief_title": "Post-Embolic Rhythm Detection With Implantable Versus External Monitoring", - "phase": "", - "drugs": "['Medtronic Reveal LINQ', 'Sorin Spiderflash-t']", - "drugs_list": [ - "Medtronic Reveal LINQ", - "Sorin Spiderflash-t" - ], - "diseases": "['Stroke', 'Atrial Fibrillation', 'Arrhythmias, Cardiac']", - "diseases_list": [ - "Stroke", - "Atrial Fibrillation", - "Arrhythmias", - "Cardiac" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of the index event* made by a stroke specialist of an acute ischemic stroke or TIA occurring within the previous 90 days. The event must be either: \n\n an arterial ischemic stroke confirmed by neuroimaging; or \n\n transient ischemic attack with diffusion weighted positive lesion on MRI \n\n At least one 12-lead ECG has already been obtained as part of the routine clinical post-stroke/TIA work-up, and no ECGs have shown any episodes of atrial fibrillation or atrial flutter \n\n The patient is being actively investigated for the etiology of the stroke/TIA event and additional cardiac monitoring is desired to screen further for the possibility of occult paroxysmal atrial fibrillation/flutter \n\n Age 18 years or older \n\n Informed consent from the patient \n\n The patient is expected to survive at least 6 months. \n\n ", - "exclusion_criteria": ": \n\n Any previously documented atrial fibrillation or atrial flutter, i.e. a past history of atrial fibrillation/flutter or atrial fibrillation/flutter detected on ECG, Holter, or telemetry following the index stroke/TIA event (a remote history of transient perioperative atrial fibrillation is not exclusionary) \n\n Planned carotid endarterectomy or carotid artery stenting within 90 days \n\n Any condition for which there is already an indication for long term anticoagulation Pacemaker or implantable cardioverter defibrillator device \n\n Work-up for stroke that has already included extended (>48 hour) external ECG (excluding telemetry) \n\n Stroke and/or comorbid illness will prevent completion of planned follow-up assessments", - "brief_summary": "The overall aim of this trial is to determine the most cost effective approach to diagnose paroxysmal atrial fibrillation (PAF) following transient ischemic attack (TIA) and stroke.~A summary of the rationale for this study is as follows:~Recently completed randomized trials of cardiac monitoring following stroke have established that PAF is more common than previously recognized in cryptogenic stroke.~The majority of TIA/stroke patients will have at least one potential stroke mechanism identified by the time etiologic investigations completed.~Detecting PAF in patients with strokes with known causes (eg. lacunar and large vessel atherosclerosis) is clinically important since appropriate anticoagulation for AF reduces stroke recurrence in all patients with prior TIA/stroke not just cryptogenic strokes.~There are competing technologies for evaluating cardiac rhythm and diagnosing AF but no cost effectiveness data~The rates of PAF in strokes with known causes (SKC) have not been well characterized.~PER-DIEM is a pilot study to compare two different cardiac monitoring technologies as first-line investigations to detect PAF in patients with recent stroke and TIA. The study will also assess whether a pivotal trial is feasible and warranted.~The principal research questions to be addressed in this study will be:~Whether implantable loop recorder (ILR) plus remote monitoring will diagnose more paroxysmal AF / atrial flutter and provide a better assessment of the total burden of AF resulting in a greater proportion of patients started on an OAC versus the external loop recorder (ELR) strategy.~What is the relative cost-effectiveness as a first-line investigation of long-term implantable ECG (ILR) coupled with remote monitoring for 12 months compared to external event-triggered ECG loop recorder (ELR) for 30 days in the diagnosis clinically actionable AF in following TIA/stroke.~2) What is the feasibility, patient compliance, diagnostic accuracy and rates of AF detection (>30 seconds) of ILR compared to the ELR strategies.", - "NCTID": "NCT02428140" - }, - { - "brief_title": "Finding Atrial Fibrillation in Patients With Unexplained Stroke Using Longterm Cardiac Monitoring", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Stroke']", - "diseases_list": [ - "Stroke" - ], - "enrollment": "85.0", - "inclusion_criteria": "inclusion criteria: \n\n Computerized Tomography (CT) or Magnetic resonance imaging (MRI) verified cryptogenic stroke or TIA; \n\n > 18 years of age, \n\n the ability to provide a written consent \n\n ", - "exclusion_criteria": ": \n\n prior or known AFIB \n\n AF found during work up including 24 hour telemetric monitoring.", - "brief_summary": "The SURPRISE study investigates atrial fibrillation(AFIB) in patients with a previous unexplained stroke. It uses long term monitoring of the heart of up to three years, searching for paroxysmal atrial fibrillation(PAF) otherwise undetected in this population.", - "NCTID": "NCT01498146" - }, - { - "brief_title": "Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Stroke', 'Foramen Ovale, Patent']", - "diseases_list": [ - "Stroke", - "Foramen Ovale", - "Patent" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years old patients \n\n signed informed consent \n\n all consecutive patients undergoing a successful percutaneous closure of a PFO secondary to a cryptogenic stroke \n\n ", - "exclusion_criteria": ": \n\n all patients with an alternative aetiology of the initial stroke \n\n all patients in whom the percutaneous closure of the PFO is contraindicated \n\n all patients with a known allergy to aspirin and or clopidogrel", - "brief_summary": "Following a cryptogenic stroke, many patients are nowadays treated with the percutaneous closure of a patent foramen ovale (PFO), assuming that the aetiology of the stroke is secondary to a paradoxical embolism. After the PFO closure procedure a dual antiplatelet regimen is often prescribed for 3-6 months and several cardiologic and neurologic follow-up exams are scheduled in the first 12 months of follow-up. Usually a transthoracic +/- transoesophageal echocardiography (TTE +/- TEE) are performed at 6 months, however this kind of control is not systematically performed. In order to improve the clinical outcomes in this young patients' population, the investigators prospectively perform a complete cardiologic and neurologic follow-up program to all patients undergoing a successful percutaneous closure of a PFO.~The aim of these controls is to confirm the good position of the PFO-device, to confirm the absence of any residual right to left shunt or any significant atrial arrhythmias Furthermore this prospective follow-up will analyze the possible mechanisms leading to a cerebral stroke recurrence (e.g. size of the PFO, presence of an atrial septal aneurysm, presence of a residual shunt, size of the utilized closure device, ....).", - "NCTID": "NCT01149447" - }, - { - "brief_title": "Diurnal Variation in Hypertensive Stroke Patients", - "phase": "Phase 4", - "drugs": "['Amlodipine, Losartan']", - "drugs_list": [ - "Amlodipine", - "Losartan" - ], - "diseases": "['Stroke', 'Hypertension']", - "diseases_list": [ - "Stroke", - "Hypertension" - ], - "enrollment": "84.0", - "inclusion_criteria": "inclusion criteria: \n\n aged 35 to 85 years \n\n hypertensive patients who had an ischemic stroke \n\n ", - "exclusion_criteria": ": \n\n patients aged below 35 years or above 86 years; \n\n patients who had a hemorrhagic stroke; \n\n patients whose systolic BP (SBP) was over 220 mmHg or whose diastolic BP (DBP) was above 120 mmHg during an acute phase, or whose SBP was over 180 mmHg or whose DBP was over 110 mmHg one week after their hospital visit; \n\n patients with secondary hypertension related to renovascular, endocrinologic, or pregnant conditions \n\n patients who went to bed in the middle of the day or very late at night; (6) patients who were using intravenous antico-agulants or thrombolytics; \n\n (7) patients with a severe stroke (NIH stroke scale > 20); (8) patients who could not give their consent to investigators; (9) patients with severely impaired liver function (AST or ALT \u2265 100); (10) patients with severely impaired renal function (serum creatinine \u2265 2.0 mg/dL); (11) patients with cancer; (12) patients who were pregnant or lactating; (13) patients with other grave diseases such as hypertensive encephalopathy, aortic dissection, acute myocardial infarction, or severe congestive heart failure; and (14) patients who were allergic to the test or control drugs", - "brief_summary": "This study was conducted to evaluate and compare the effectiveness of Amodipin\u00ae (amlodipine camsylate) with that of Cozaar\u00ae (losartan potassium) in hypertensive patients with an acute ischemic stroke by measuring their 24-hour ambulatory BP (ABP).", - "NCTID": "NCT01830517" - }, - { - "brief_title": "U-CHAMP: Urban Cardiovascular Health Assessment and Management Program", - "phase": "", - "drugs": "['participant referral to primary care network physician']", - "drugs_list": [ - "participant referral to primary care network physician" - ], - "diseases": "['Cardiovascular Diseases', 'Hypertension', 'Hyperlipidemia', 'Hyperglycemia']", - "diseases_list": [ - "Cardiovascular Diseases", - "Hypertension", - "Hyperlipidemia", - "Hyperglycemia" - ], - "enrollment": "110.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults 18-85 years \n\n Signed consent \n\n ", - "exclusion_criteria": ": \n\n None", - "brief_summary": "High blood pressure, elevated blood glucose and high cholesterol are related to the increased risk of stroke and heart disease. Many studies have shown that this risk can be significantly reduced by lowering blood pressure, blood glucose and cholesterol levels.~Through a collaborative effort between Calgary Safeway pharmacists and Calgary Health Region family physician PCN's, U-CHAMP will deliver a program to assist in the identification and management of people with elevated blood pressure, blood glucose and cholesterol and through this effort, reduce the risk of heart disease and stroke in the urban Calgary population aged 18-85 years.", - "NCTID": "NCT00626041" - }, - { - "brief_title": "Systolic Hypertension in the Elderly Program (SHEP) (Pilot Study)", - "phase": "Phase 2", - "drugs": "['chlorthalidone', 'reserpine', 'hydralazine', 'metoprolol']", - "drugs_list": [ - "chlorthalidone", - "reserpine", - "hydralazine", - "metoprolol" - ], - "diseases": "['Cardiovascular Diseases', 'Heart Diseases', 'Hypertension', 'Vascular Diseases']", - "diseases_list": [ - "Cardiovascular Diseases", - "Heart Diseases", - "Hypertension", - "Vascular Diseases" - ], - "enrollment": "", - "inclusion_criteria": "Men and women, aged 60 or over. Isolated systolic hypertension. Normal diastolic pressure of less than 90 mm Hg.", - "exclusion_criteria": "", - "brief_summary": "The SHEP Pilot Study had six objectives, each designed to develop and test critical components of a full scale trial directed at the health consequences of treating isolated systolic hypertension (ISH) in the elderly.~l. To estimate and compare the yield of participants for randomization into a clinical trial from various community groups using various recruitment techniques.~2. To estimate compliance with the visit schedule and to the prescribed double-blind regimens.~3. To estimate and compare the effectiveness of specified antihypertensive medications in reducing the blood pressure.~4. To estimate and compare the unwanted effects of specified antihypertensive medication in an elderly population.~5. To evaluate the feasibility and effectiveness of periodic behavioral assessment in this population.~6. To develop and test methods of ascertaining stroke and other disease endpoints.", - "NCTID": "NCT00000499" - }, - { - "brief_title": "Efficacy and Security of an Endovascular Treatment as First Choice Procedure Compared With a Standard Intravenous Thrombolytic Therapy Treatment for Patients With Acute Ischemic Stroke Within 4.5 Hours After Onset", - "phase": "", - "drugs": "['EVT (endovascular treatment )', 'IVT (intravenous thrombolytic therapy)']", - "drugs_list": [ - "EVT (endovascular treatment )", - "IVT (intravenous thrombolytic therapy)" - ], - "diseases": "['Acute Ischaemic Stroke']", - "diseases_list": [ - "Acute Ischaemic Stroke" - ], - "enrollment": "124.0", - "inclusion_criteria": "inclusion criteria: \n\n 80 or less years old patients with acute stroke produced by a main artery occlusion \n\n NIHSS National Institutes of Health Stroke Scale score greater than 6 (severe neurological impairment) \n\n Patients receiving EVT or IVT within 4.5 hours after onset \n\n ", - "exclusion_criteria": ": \n\n EVT or IVT contraindication \n\n Previous neurological impairment, severe concomitant disease or poor prognosis. \n\n Pregnancy or breastfeeding \n\n Known hypersensitivity to any study drugs \n\n Severe organic disease for which there is not risk compensation.", - "brief_summary": "This study will compare two ways of treatment for acute ischemic stroke: an endovascular treatment (EVT), defined as intraarterial thrombolysis and/or mechanical thrombectomy as a first choice treatment versus intravenous thrombolytic therapy (IVT) only or followed by EVT in patients with acute ischemic stroke due to a main brain artery occlusion within 4.5 hours after onset. Patients treated with IVT only or with IVT followed by EVT will be analyzed separately.", - "NCTID": "NCT02164357" - }, - { - "brief_title": "IV Double and Triple Concentrated Nicardipine for Stroke and ICH", - "phase": "Phase 4", - "drugs": "['Nicardipine']", - "drugs_list": [ - "Nicardipine" - ], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Males or females, 18 years of age or older. \n\n Acute ischemic cerebral stroke (IS) with uncontrollable hypertension that may need to be controlled for the purpose of considering thrombolytic therapy or anticoagulation therapy. \n\n Intracerebral hemorrhagic (ICH) stroke patients, including subarachnoid hemorrhage (SAH) (surgically treated or not), any territory with an appropriate study (head CT scan or MRI scan) providing results consistent with this diagnosis, who may require the control of hypertension or control of blood pressure. \n\n ", - "exclusion_criteria": ": \n\n Allergy to Nicardipine or known hypersensitivity to Nicardipine. \n\n Chronic renal failure or Creatinine blood sample levels> 2.0. \n\n Impaired hepatic function defined as a two times value of liver enzymes. \n\n Severe left ventricular dysfunction defined as ventricular ejection fraction < 30%. \n\n Patients or authorized representative who refused be enrolled into this study. \n\n Advanced aortic stenosis. \n\n Pregnant or nursing women will not be enrolled in this study. \n\n No patient will be allowed to be enrolled in this study more than once. \n\n Patients may not be enrolled into other clinical studies during their involvement with this study.", - "brief_summary": "Hypertension (high blood pressure) can often cause neurological worsening in patients with stroke, intracerebral hemorrhage and subarachnoid hemorrhage. Intravenous infusion of nicardipine (Cardene) for control of hypertension is FDA approved. The disadvantage of Nicardipine IV drip is the relative large volume of fluid needed (up to 150 cc/hr). The purpose of this study is to evaluate safety and efficacy of double or triple concentrated peripheral intravenous (IV) Nicardipine.", - "NCTID": "NCT00325793" - }, - { - "brief_title": "Stroke DOC Arizona TIME - Stroke Team Remote Evaluation Using a Digital Observation Camera", - "phase": "", - "drugs": "['Telephone', 'Two way audio/video telemedicine consult']", - "drugs_list": [ - "Telephone", - "Two way audio/video telemedicine consult" - ], - "diseases": "['Stroke, Acute']", - "diseases_list": [ - "Stroke", - "Acute" - ], - "enrollment": "60.0", - "inclusion_criteria": "Subject inclusion criteria \n\n For inclusion in the study, subjects must fulfill all of the following criteria: \n\n Written Informed Consent \n\n Eighteen years of age or older \n\n Symptoms consistent with acute stroke (ischemic or hemorrhagic) \n\n Acute presentation of stroke symptoms, per bedside physician discretion (onset generally less than 12 hours and likely less than 3 hours) \n\n Subject ", - "exclusion_criteria": " \n\n The following is the sole criterion for exclusion from the study: \n\n Unlikely to complete study through 90-day follow-up", - "brief_summary": "Noninvasive prospective multi-center study of an interactive 2-way, wireless or site-independent, audiovisual telemedicine system designed for real-time remote examination of acute stroke symptoms and deficits as a basis for treatment consultation and recommendation.~Study aims (1) to determine the impact of a site-independent, remote, telemedicine consultation system on decision making in the Emergency Department, regarding the decision to treat or not to treat with thrombolytics; (2) to assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine versus telephone only; (3) to assess the appropriateness of thrombolytic treatment decisions in telemedicine versus telephone-only consultations; and (4) to assess the completeness of the data collection in telemedicine versus telephone-only consultations.~60 patients in Arizona with acute presentation of stroke symptoms, per bedside practitioner discretion (onset generally less than 12 hours and likely less than 3 hours)~Two arms: Video Camera/Telemedicine (Intervention n = 30) and No Video Camera/Telephone only (Control n = 30)", - "NCTID": "NCT00623350" - }, - { - "brief_title": "The Effect of Leucine on Body Composition and Muscle Characteristics in Elderly, Type 2 Diabetes Patients", - "phase": "Phase 2; Phase 3", - "drugs": "['Leucine', 'Wheat flour']", - "drugs_list": [ - "Leucine", - "Wheat flour" - ], - "diseases": "['Type 2 Diabetes']", - "diseases_list": [ - "Type 2 Diabetes" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of type 2 diabetes \n\n ", - "exclusion_criteria": ": \n\n Impaired renal or liver function \n\n Cardiac disease \n\n Subjects with metal implants \n\n Hypertension \n\n Diabetes complications \n\n Exogenous insulin therapy", - "brief_summary": "The purpose of this study is to determine whether long term leucine supplementation has a positive effect on body composition and muscle characteristics in elderly, type 2 diabetes patients.", - "NCTID": "NCT00643773" - } - ] - }, - { - "patient_id": "sigir-201516", - "patient": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", - "0": [ - { - "brief_title": "Upper Airway Microbial Development During the First Year of Life", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "180.0", - "inclusion_criteria": "inclusion criteria: \n\n Moms age 14 and older (will sign Informed Consent Statement (ICS), not an assent) \n\n Mother of child enrolled must have a physician diagnosis of asthma or being treated for asthma (for 140 subjects; 40 subjects will be recruited from mothers and fathers without atopy - asthma, eczema, seasonal allergies) \n\n Child must be enrolled during first week of life \n\n Signed informed consent from parent(s) or legal guardian(s) \n\n ", - "exclusion_criteria": ": \n\n Child has a history of wheezing or underlying lung disease \n\n Respiratory complications at birth (airway support higher then nasal cannula) \n\n Born earlier then 37 weeks gestation \n\n Congenital heart defects (not including Patent Ductus Arteriosus (PDA), hemodynamically insignificant Ventricular Septal Defect (VSD) or Atrial Septal Defect (ASD) \n\n Underlying neuromuscular disease \n\n Severe upper airway obstruction, sleep apnea, tracheomalacia, or laryngomalacia \n\n Hydrocephalus \n\n History of seizures \n\n History of arrhythmia and baseline oxygenation level <90% on room air \n\n Infant is non-viable \n\n Severe gastroesophageal reflux \n\n Prior chest surgery or structural abnormalities of the lungs or chest wall \n\n Has a history of adverse reaction to chloral hydrate \n\n Ward of the state \n\n Any physical finding(s) that would compromise the safety of the subject or the quality of the study data as determined by the site investigator", - "brief_summary": "This study tests the hypothesis that an increase in pathogenic bacteria within the infant airway leads to increased airway inflammation, decreased airway function and ultimately airway obstruction throughout the first one to two years of life.", - "NCTID": "NCT01978288" - }, - { - "brief_title": "A Study to Evaluate MK0476 and Fluticasone to Control Asthma in Patients With Mild Persistent Asthma (0476-910)", - "phase": "Phase 3", - "drugs": "['MK0476, montelukast sodium / Duration of Treatment: 1 Year', 'Comparator : fluticasone propionate / Duration of Treatment: 1 Year']", - "drugs_list": [ - "MK0476", - "montelukast sodium / Duration of Treatment: 1 Year", - "Comparator : fluticasone propionate / Duration of Treatment: 1 Year" - ], - "diseases": "['Asthma, Bronchial']", - "diseases_list": [ - "Asthma", - "Bronchial" - ], - "enrollment": "994.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient is male or female, 6-14 years of age with mild persistent asthma \n\n Patient has a history of the following symptoms: wheezing, chest tightness, cough, etc. \n\n Patient has asthma diagnosed by a doctor \n\n ", - "exclusion_criteria": ": \n\n Patient is hospitalized \n\n Patient has had major surgery or participated in another clinical trial in the last 4 weeks \n\n Patient has been on a breathing tube for asthma", - "brief_summary": "A study to evaluate MK0476 and Fluticasone to control asthma in patients with mild persistent asthma.", - "NCTID": "NCT00489346" - }, - { - "brief_title": "Study of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Hayfever With or Without Asthma (P03472)", - "phase": "Phase 3", - "drugs": "['Desloratadine']", - "drugs_list": [ - "Desloratadine" - ], - "diseases": "['Rhinitis, Allergic, Seasonal', 'Asthma']", - "diseases_list": [ - "Rhinitis", - "Allergic", - "Seasonal", - "Asthma" - ], - "enrollment": "54.0", - "inclusion_criteria": "inclusion criteria: \n\n Children must be >= 6 to < 12 years of age of either sex and any race. \n\n Children's parent(s) or legal representative(s) must demonstrate their willingness to participate in the study and comply with its procedures by signing an informed consent \n\n Children must be free of any clinically significant disease (other than SAR) that would interfere with study evaluations \n\n Children's parent(s) or legal representative(s) must understand and be able to adhere to dosing and visit schedules, agree to report concomitant medications and adverse events to the Investigator or designee \n\n The diagnosis of seasonal allergic rhinitis with or without intermittent asthma will be assessed by: \n\n Clinical history of sneezing, rhinorrhea (nasal discharge/running nose or post-nasal drip), nasal stuffiness/congestion and nasal itching and non-nasal symptoms (eye symptoms) as itching, burning, tearing and redness, during the previous pollen season \n\n Ascertained skin prick positivity (or RAST positivity) to one of the following: grasses, parietaria, birch, hazelnut (the skin test has to be performed within the last year) \n\n Children must be clinically symptomatic with SAR at Visit 1 (day 1): the total (nasal + non nasal) symptoms score must be >= 8 with a nasal congestion score of >= 2, and the non-nasal symptoms severity score must be >= 2 \n\n Asthma symptoms (wheezing, cough, difficulty breathing, chest tightness) will be evaluated at visit 1 (day 1) and graded only for child with concomitant asthma \n\n ", - "exclusion_criteria": ": \n\n Children who have not observed the designated washout periods for any of the prohibited medications \n\n Children with persistent asthma (mild, moderate or severe) or perennial allergic rhinitis (PAR) \n\n Children with rhinitis medicamentosa \n\n Children who have had an upper respiratory tract or sinus infection that required antibiotic therapy within 14 days prior to Visit 1 (day 1), or children who have had a viral upper respiratory infection within 7 days prior to Visit 1 (day 1) \n\n Children who have nasal structural abnormalities, including nasal polyps and marked septal deviation, that significantly interfere with nasal airflow \n\n Children who, in the opinion of the Investigator, are dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids \n\n Children with a history of hypersensitivity to desloratadine or any of its excipients \n\n Children who have any current clinically significant metabolic, cardiovascular, hepatic, renal, immunologic, neurologic, hematologic, gastrointestinal, cerebrovascular or respiratory disease, or any other disorder which, in the judgment of the Investigator, may interfere with the study evaluations or affect subject safety \n\n A known lack of response to H1-antihistamines", - "brief_summary": "The purpose of this study was to test the effectiveness and safety of desloratadine (Aerius) syrup in children with hayfever with or without asthma. Patients took desloratadine syrup once a day for 28 days. Once a week, the doctor measured the patient's hayfever symptoms. The doctor also rated how much relief the patient got from treatment and recorded any side effects.", - "NCTID": "NCT00805324" - }, - { - "brief_title": "Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic Disease", - "phase": "", - "drugs": "['Collection of nasal epithelial cells']", - "drugs_list": [ - "Collection of nasal epithelial cells" - ], - "diseases": "['Allergic Rhinitis']", - "diseases_list": [ - "Allergic Rhinitis" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients: \n\n Patients between 6 and 17 years old \n\n Patients with allergic rhinitis \n\n Witness: \n\n Patients between 6 and 17 years old \n\n Patients without allergic rhinitis and asthma \n\n ", - "exclusion_criteria": ": \n\n Rhino-bronchitis infection dated from less than 15 days \n\n Patients younger than 6 or older than 17 years", - "brief_summary": "Using a human pangenomic microarray, the researchers established expression profiles of nasal epithelial cells, collected by brushing of patients belonging to one of four distinct groups:~allergic rhinitis to dust mite (AR) isolated (n=12),~AR associated with bronchial hyperreactivity (n=12),~AR associated with asthma (n=14),~control (n=14).", - "NCTID": "NCT00569361" - }, - { - "brief_title": "Pediatric Asthma Alert Intervention for Minority Children With Asthma", - "phase": "Phase 2", - "drugs": "['Pediatric Asthma Alert (PAAL)', 'Standard asthma education']", - "drugs_list": [ - "Pediatric Asthma Alert (PAAL)", - "Standard asthma education" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "350.0", - "inclusion_criteria": "inclusion criteria: \n\n All 6 criteria must be met: \n\n Physician-diagnosed asthma (based on caregiver report with validation from the child's physician) \n\n > 2 ED visits or > 1 hospitalization for asthma within past 12 months \n\n Mild persistent to severe persistent asthma based on NHLBI guidelines criteria (7-9) having any 1 of the following: \n\n An average of > 2 days per week of asthma symptoms \n\n > 2 days per week with rescue medication use (albuterol, xopenex) OR \n\n > 2 days per month of nighttime symptoms \n\n Age > 3 and < 10 years \n\n Reside in Baltimore Metropolitan area \n\n Not currently participating in another asthma study or sibling enrolled in PAAL study \n\n ", - "exclusion_criteria": ": \n\n Inability to speak and understand English \n\n No access to a working phone or alternate phone for follow-up surveys \n\n Co-morbid respiratory condition including cystic fibrosis, chronic lung disease (BPD), lung cancer, tracheostomy that could interfere with the assessment of asthma-related outcome measures. \n\n Children residing in foster care or where consent cannot be obtained from a legal guardian.", - "brief_summary": "Young inner-city children with asthma have the highest emergency department (ED) visit rates. Relying on the emergency department for asthma care can be a dangerous sign of poorly controlled asthma. This research will focus on whether having a specialized asthma nurse join the family at a child's doctor visit after an ED visit for asthma to make sure the child and parent keep the follow-up appointment and have the nurse remind the child's doctor to prescribe preventive asthma medicines and an asthma action plan for home (PAAL intervention) will result in young children with asthma having fewer days with wheezing and cough.~The investigators hypothesize that:~Significantly more children receiving the PAAL intervention will attend greater than 2 non-urgent visits and greater than 6 refills for the child's anti-inflammatory medications over 12 months when compared to children in the control or standard asthma education group.~Children in the PAAL intervention group will experience less morbidity and caregivers will experience increased quality of life compared to children in the control of standard asthma education group.", - "NCTID": "NCT00860418" - }, - { - "brief_title": "Promoting Tolerance to Common Allergens in High-Risk Children: Global Prevention of Asthma in Children (GPAC) Study", - "phase": "Phase 2", - "drugs": "['Oral mucosal immunoprophylaxis (OMIP)', 'Placebo']", - "drugs_list": [ - "Oral mucosal immunoprophylaxis (OMIP)", - "Placebo" - ], - "diseases": "['Allergic Sensitization', 'Asthma']", - "diseases_list": [ - "Allergic Sensitization", - "Asthma" - ], - "enrollment": "51.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosed with eczema (atopic dermatitis) \n\n Family history of eczema, allergic rhinitis, or asthma \n\n Allergy to one or more of the following: egg white, cow's milk, peanut, or soybean \n\n Weigh at least 9.5 kg (20.9 lbs) \n\n Parent or guardian willing to provide informed consent \n\n ", - "exclusion_criteria": ": \n\n Allergy to house dust mite, cat, or timothy grass \n\n Born prematurely (before 36th week's gestation) \n\n Previous diagnosis of asthma OR have had 3 or more distinct episodes of wheeze during the first year of life \n\n Chronic pulmonary disease \n\n Chronic disease requiring therapy \n\n Past or current treatment with systemic immunomodulator medication \n\n Past or current treatment with allergen-specific immunotherapy \n\n Received 10 or more days of systemic steroids in the 3 months prior to study entry \n\n Orofacial abnormalities that are likely to interfere with the subject's ability to take study treatment \n\n Participated in another clinical study within the 3 months prior to study entry", - "brief_summary": "The purpose of this study is to determine whether early childhood exposure to common allergens (substances that can trigger allergies and asthma) can prevent the development of asthma in children at high risk for developing the disease.", - "NCTID": "NCT00346398" - }, - { - "brief_title": "Management of Recurrent Croup", - "phase": "Phase 3", - "drugs": "['Fluticasone', 'Prednisolone IF needed']", - "drugs_list": [ - "Fluticasone", - "Prednisolone IF needed" - ], - "diseases": "['Croup']", - "diseases_list": [ - "Croup" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Pediatric population: 6 months to 15 years of age \n\n 2 or more episodes of croup in 12 month period \n\n croup defined as acute onset inspiratory stridor, barking cough, with respiratory distress. \n\n ", - "exclusion_criteria": ": \n\n Grade 3 or 4 subglottic stenosis \n\n Subglottic hemangioma \n\n Posterior laryngeal cleft \n\n Recurrent respiratory papillomatosis \n\n External compression (Innominate artery compression, mediastinal mass, (double aortic arch, etc) \n\n Symptoms or signs suggesting another cause of stridor, such as epiglottitis, bacterial tracheitis, or supraglottic foreign body \n\n Tracheomalacia/ bronchomalacia severe enough to cause respiratory distress \n\n Current steroid therapy for previously diagnosed condition, i.e. reactive airway disease. \n\n Other medical conditions necessitating chronic steroid utilization", - "brief_summary": "Presently children who experience recurring croup symptoms receive a variety of treatments. This is because it is not clear which treatments may be best. Some children are given inhaled steroids (similar to what children with asthma use). Others are carefully watched and cautioned to avoid potential triggers (certain foods, environmental allergens, etc), and should episodes of croup recur they are treated with a short course of oral steroids. The purpose of this study is to compare two safe and clinically appropriate methods for treating recurrent croup, daily inhaled steroids versus observation with oral steroids on an as needed basis, to see if either is useful in preventing future episodes of croup.", - "NCTID": "NCT01748162" - }, - { - "brief_title": "An Approved Drug to Study a New Indication for Seasonal Allergic Rhinitis in Patients With Asthma (0476-269)", - "phase": "Phase 3", - "drugs": "['MK0476, montelukast sodium', 'Comparator: placebo']", - "drugs_list": [ - "MK0476", - "montelukast sodium", - "Comparator: placebo" - ], - "diseases": "['Rhinitis, Allergic, Seasonal', 'Asthma, Bronchial']", - "diseases_list": [ - "Rhinitis", - "Allergic", - "Seasonal", - "Asthma", - "Bronchial" - ], - "enrollment": "831.0", - "inclusion_criteria": "inclusion criteria: \n\n Non-smoker \n\n A 2-year documented history of seasonal allergic rhinitis \n\n A 1-year documented history of chronic asthma \n\n Positive allergy testing \n\n ", - "exclusion_criteria": ": \n\n Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.", - "brief_summary": "The purpose of this study is to determine the effect of an approved medication on the symptoms of seasonal allergic rhinitis (a seasonal variety of inflammation of the mucous membrane of the nose) in patients who are experiencing symptoms of seasonal allergic rhinitis and asthma.", - "NCTID": "NCT00092885" - }, - { - "brief_title": "The Effect of Allergen Immunotherapy on Exhaled Nitric Oxide in Adult Patients With Asthma and Allergic Rhinitis", - "phase": "", - "drugs": "['Allergen immunotherapy']", - "drugs_list": [ - "Allergen immunotherapy" - ], - "diseases": "['Allergic Asthma', 'Allergic Rhinitis']", - "diseases_list": [ - "Allergic Asthma", - "Allergic Rhinitis" - ], - "enrollment": "17.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects over 18 years old with allergic asthma and/or allergic rhinitis who are beginning allergen desensitization \n\n ", - "exclusion_criteria": ": \n\n Smokers \n\n Subjects of dimished capacity", - "brief_summary": "This study will evaluate whether exhaled nitric oxide levels are affected by allergen immunotherapy (allergy shots). The investigators' hypothesis is that successful allergen immunotherapy may be accompanied by decreased exhaled nitric oxide levels.", - "NCTID": "NCT01318954" - }, - { - "brief_title": "Assessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone", - "phase": "Phase 3", - "drugs": "['beclomethasone dipropionate', 'placebo']", - "drugs_list": [ - "beclomethasone dipropionate", - "placebo" - ], - "diseases": "['Asthma', 'Allergic Rhinitis']", - "diseases_list": [ - "Asthma", - "Allergic Rhinitis" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n children with intermittent asthma and allergic rhinitis \n\n ", - "exclusion_criteria": ": \n\n children with acute respiratory symptoms in the last 4 weeks \n\n children with nasal polyposis or bronchial or respiratory tract infections \n\n children with a severe exacerbation of asthma resulting in hospitalization during the last month", - "brief_summary": "Although it is well known that the presence of uncontrolled inflammation in upper airways may compromise the control of asthma and may favor the progression of asthma toward more severe grades of disease, few studies addressed whether therapies aimed to control both upper and lower airway inflammation may be more effective in controlling asthma. Markers of oxidative stress and of inflammation such as Nitrotyrosine and IL-5 are increased in the airways of children with atopic asthma and correlated with the levels of oral and nasal FeNO, and with the grade of atopy. We hypothesize that the treatment with Beclometasone nebulized with a facial mask (for treating both upper and lower airways) will be able to reduce the production of oxidants as well as of IL5 in both districts thus promoting clinical and functional improvements in mild intermittent asthmatic children. The results provided by this study will contribute to further clarify the relationship between nasal and bronchial inflammation.", - "NCTID": "NCT01113489" - }, - { - "brief_title": "Studio NaVA - National Study on Quality of Life in Adolescents Affected by Allergic Rhinitis With or Without Asthma", - "phase": "", - "drugs": "['Data Collection']", - "drugs_list": [ - "Data Collection" - ], - "diseases": "['Allergic Rhinitis', 'Asthma']", - "diseases_list": [ - "Allergic Rhinitis", - "Asthma" - ], - "enrollment": "1200.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical cases n\u00b0: 600 adolescents affected by allergic rhinitis with/without asthma, from 14 to 17 years age. \n\n Controls n\u00b0: 600 subject (5 for each participant Pediatrician) of the same age range, without respiratory pathology. \n\n ", - "exclusion_criteria": ": \n\n Subjects that have not allergic rhinitis with/without asthma diagnosis or are <14 years old or >17 years old", - "brief_summary": "Studio Nava is a National Study aiming to assess allergic rhinitis and asthma outcomes on Quality of Life and Quality of Sleep in adolescent patients by means of Web Survey. Studio Nava also proposes the innovative use of a web platform (http://nava.ibim.cnr.it/) that contains all standardized tools (medical-healthcare web form, ACT, Asthma control test; PSQI, Pittsburgh Sleep Quality Index; T5SS, Total Symptom Score; modified SIDRIA for adolescents; Rhinasthma; VAS scale), that will be available for the doctors after the registration to the web platform. Downloaded questionnaires will be delivered to case-patient, asking him/her to fill them during the waiting time of the visit.", - "NCTID": "NCT02380495" - }, - { - "brief_title": "A Comparison of Combivent UDV (Ipratropium 500mcg and Salbutamol 2.5mg) and Salbutamol UDV Alone (2.5mg)", - "phase": "Phase 4", - "drugs": "['ipratropium plus salbutamol UDV', 'salbutamol UDV']", - "drugs_list": [ - "ipratropium plus salbutamol UDV", - "salbutamol UDV" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "500.0", - "inclusion_criteria": "inclusion criteria \n\n All patients must have a known history of asthma and present to the hospital/clinic with severe acute exacerbation. \n\n Male or female patients 2 to 10 years of age. \n\n Parents or legal guardians of patients must sign an Informed Consent Form prior to participation in the trial. \n\n ", - "exclusion_criteria": " \n\n Patients with known or suspected hypersensitivity to study drugs \n\n Patients with medical condition that would contraindicate the use of beta2-adrenergic or anticholinergic medications \n\n Patients with first wheezing episode only \n\n Prior intubation for asthma for more than 24 hours \n\n Patients who used ipratropium within six hours prior to consultation \n\n Patients with concurrent stridor or possible presence of intra-thoracic foreign body \n\n Patients with disease known to have chronic effect on respiratory function ( e.g., cystic fibrosis or cardiac disease) \n\n Patients requiring immediate resuscitation or airway intervention \n\n With psychiatric disease or psychosocial problems \n\n Patients on other investigational drugs or have used any other investigational drugs within the past month", - "brief_summary": "To compare the bronchodilator efficacy of ipratropium plus salbutamol (Combivent) with salbutamol alone given every 20 minutes for three doses in asthmatic children with severe acute exacerbation", - "NCTID": "NCT00273962" - }, - { - "brief_title": "Children With Asthma in New Orleans After Hurricane Katrina", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Asthma', 'Allergies']", - "diseases_list": [ - "Asthma", - "Allergies" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n A child will be included in the HEAL intervention study if he or she: \n\n Is a male or female child four to twelve years old, inclusive, at the time of recruitment, living in Orleans Parish or surrounding areas impacted by flooding. \n\n Has previously been given a diagnosis of asthma by a healthcare provider and who has symptoms as described below (Criteria 3) for more than one year. \n\n Is currently receiving long-term asthma control therapy, as reported at baseline, and either has symptoms consistent with persistent asthma (criterion 3a, see below) or has evidence of uncontrolled disease (criterion 3b); or is not currently receiving long-term asthma control therapy and has symptoms consistent with persistent asthma (criterion 3a) and also has evidence of uncontrolled disease (criterion 3b): \n\n 3a. Evidence of persistent asthma as defined by the National Asthma Education and Prevention Program (NAEPP) of the National Heart Lung and Blood Institute Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma (1997), which includes: asthma symptoms 3 or more days per week during the last two weeks, sleep disturbed due to asthma at least 3 times in the past month, or albuterol use (Metered Dose Inhaler or nebulizer) for quick relief at least 8 times in the past two weeks, not including use as a preventive for exercise. \n\n 3b. Evidence of uncontrolled disease as defined by at least one of the following additional criteria: \n\n i. One asthma-related unscheduled visit to an emergency department (ED), urgent care (UC), or clinic in the previous 12 months. \n\n ii. One asthma-related overnight hospitalization in the previous 12 months. \n\n iii. One or more bursts of oral corticosteroids or equivalent in the previous 12 months. \n\n 4) Has a parent or legal guardian willing to sign the written informed consent prior to initiation into the study. \n\n 5) Is willing to sign the assent form, if age appropriate. \n\n ", - "exclusion_criteria": ": \n\n A child will be excluded from the HEAL intervention study if she or he: \n\n Is defined as having mild intermittent asthma at baseline evaluation. \n\n Has had a life-threatening asthma exacerbation in the last 5 years requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure. \n\n Has significant medical illnesses other than asthma such as: any hematologic, endocrine, respiratory (other than asthma) or cardiac condition requiring daily medications; significant neurological disorder requiring daily medications; any clotting disorder; any obvious severe mental retardation that prohibits the child or the child s caregiver from answering questions or following instructions; any autoimmune disease; any immune deficiency; or any other serious medical condition including Juvenile diabetes mellitus, hypo- or hyper- thyroidism, hemophilia, Von Willebrands disease, sickle cell disease, cerebral palsy, rheumatoid arthritis, lupus, psoriasis, hyperimmunoglobulin E syndrome, or diagnosed allergic bronchopulmonary aspergillosis. \n\n Has not had a home evaluation completed within 4-6 weeks of the Screening Visit (may be re-screened). \n\n Lives with a foster parent. \n\n Has caregiver (typically the parent or guardian) who does not have access to a phone. \n\n Plans to move out of the recruitment area over the next year. \n\n One child from each household will be selected to participate in the study. In the case of multiple eligible children, the youngest child will be included in the study.", - "brief_summary": "This study will examine whether exposure to the increased levels of mold and other allergens in New Orleans post-Hurricane Katrina affect symptoms in children with asthma. It will also determine if having an asthma counselor (AC) can reduce a child s asthma symptoms in this setting. An AC helps the families in the study obtain appropriate health care, medicines and social services for their asthmatic child and instructs them about avoiding allergens and ridding allergens from the home.~Children between 4 and 12 years of age living in Orleans Parish or surrounding areas impacted by flooding who have moderate to severe asthma may be eligible for this study.~Parents provide a family medical history and information about the child s asthma symptoms, medications and medical history. The children undergo the following procedures:~Medical examination and blood tests~Spirometry (for children 6 and older) or peak flow (for children under 6) test: For spirometry, the child wears a nose clip and breathes into a mouthpiece attached to a machine that measures how fast air moves out of the child s lungs. For the peak flow meter test, the child blows into a plastic tube after taking a deep breath.~Allergy skin testing: 24 common allergens are applied to the arm by little pricks or scratches and the skin is observed for reactions to the allergens.~Study staff visit the participants homes three times during the 1-year study to test for moisture, mold and other allergens. After the first visit, families are randomly assigned to one of two groups. Group 1 participants attend two educational group sessions about asthma and then three individual sessions. An AC visits the home one time during the study to instruct the family on how to use supplies provided to reduce allergens in the home. Group 2 participants have an individual special teaching meeting with the AC at the end of the study. After the meeting, the AC visits the home to instruct the family on use of the supplies.~Families are surveyed by phone every 3 months during the study to answer questions about the child s asthma attacks, medicines used, doctor visits, school days, missed, or work days missed to care for the child. At the end of the study, the child has a final medical examination, blood test, and breathing test.", - "NCTID": "NCT00426634" - }, - { - "brief_title": "Efficacy and Safety of Fluticasone Propionate(FP)/ Salmeterol Xinafoate (SLM) Hydro Fluoro Alkane (HFA) Metered Dose Inhaler (MDI) in Pediatric Patients With Bronchial Asthma", - "phase": "Phase 4", - "drugs": "['FP/ SLM HFA MDI 50/25 mcg', 'FP HFA MDI 50 mcg']", - "drugs_list": [ - "FP/ SLM HFA MDI 50/25 mcg", - "FP HFA MDI 50 mcg" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n The written informed consent must be obtained from his/her parent or legally acceptable representative. If the investigator can get the oral consent from the patient, the investigator should record so in the informed consent which is signed by his/her parent or legally acceptable representative. \n\n Ethnic origin is Japanese \n\n Aged >=6 months and <=4 years at Visit 1. \n\n Male and pre-menarchial female. Pre-menarchial females are defined as any female who has yet to begin menses. \n\n Patient: outpatient \n\n Diagnosis as a pediatric asthma has been made by reference to JPGL 2012 and the document which is of help as evidence should be kept as source document. As for <2 years old, children are going to be diagnosed according to an instruction as follows in JPGL2012 as a reference. There are 3 or more episodes of marked expiratory wheezing, regardless of the presence of respiratory tract infection. It is also needed to confirm that there is asymptomatic period for about a week between each episode. In addition to this finding, if there is at least one of following findings, it is more helpful to diagnose infantile asthma: At least one of parents is diagnosed with bronchial asthma by a physician (including past history); Specific immunoglobulin E (IgE) antibody for inhalation antigen is detected in at least one of parents; Diseased child is diagnosed with atopic dermatitis by a physician (including past history); Specific IgE antibody for inhalation antigen is detected in diseased child; High serum IgE level in diseased child or his/her family (serum IgE level should be determined by considering age); Eosinophils and creola bodies found in sputum (examine nasal discharge eosinophilia and peripheral blood eosinophilia); Expiratory wheezing occurs when there is no airway infection; Expiratory wheezing and labored respiration or oxygen saturation are improved after beta-2 stimulant inhalation. \n\n A patient who needs to be treated with Inhaled corticosteroid (ICS)/ Long-acting beta 2 agonist (LABA) and fulfill following all conditions: At least one documented exacerbation in that the patient treated with systemic glucocorticosteroids, aminophylline dose intravenous(d.i.v) or continuous isoproterenol inhalation in the 12 months prior to Visit 1. Or a well-documented regular treatment with ICS (FP 200-400 mcg daily or equivalent) continuous use in the 12 months prior to Visit 1; The patient has not received systemic glucocorticosteroids, aminophylline d.i.v., ICS (FP>200 mcg daily or equivalent) or continuous isoproterenol inhalation within 4 weeks prior to Visit 1. \n\n ", - "exclusion_criteria": ": \n\n A patient who has suffered from upper and lower respiratory tract infection and then received medication within 2 weeks prior to Visit 1. \n\n A patient who is diagnosed upper and lower respiratory tract infection at Visit 1. Or a patient who has or is suspected to have deep-seated mycosis or infection to which no effective antibacterial agent is available. Or a patient who is suspected to have respiratory syncytial (RS) virus infection and cannot be identified to be negative for RS virus antigen. \n\n A patient who has respiratory disorder other than bronchial asthma, and the investigator judges the respiratory disorder affect the assessment of efficacy in this study. \n\n A patient who has unstable liver disease or chronic stable hepatitis B receiving significant immunosuppressive agents due to risk of hepatitis B reactivation. \n\n A patient who has malformation/foreign particle lodged in an airway. Or subjects who have known, pre-existing, clinically significant gastroesophageal reflux disease , endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment. \n\n A patient who has or is suspected to have hypersensitivity to study medications, the rescue medication or any ingredients of them. \n\n A patient who has been treated with another investigational product within 1 months prior to Visit 1 or within five half-lives (t-half) of the prior investigational study (whichever is the longer of the two). \n\n As for the patients who has evaluable ECG data at Visit 1, QT interval corrected (Fridericia) for heart rate (QTc[F])>=450 milliseconds (msec). The QT interval corrected for heart rate (QTc) should be based on averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period. As for the patients who don't has evaluable ECG data at Visit 1, if the patient has known prolonged QTc>=450 msec (any correction is valid), the patient will be excluded. \n\n A patient who is child in care (including foster parent system), or whom the investigator judges inappropriate for the study. \n\n Randomization Inclusion Criterion : \n\n A patient who has asthma symptoms scores (total of daytime and night-time) both over >=6 in total and >=1 per day for >=3 days at the last 7 consecutive days of the run-in period (excluding the day of Visit 2). Completion of symptom scores (daytime and night-time) on 5 or more days out of the last 7 consecutive days during the run-in period is required. \n\n Randomization ", - "brief_summary": "This study is a multicenter, stratified, randomized, active control, double-blinded, parallel-group comparative study with an open-label extension period. The study is designed to evaluate the efficacy and safety of FP/ SLM HFA MDI 50/25 microgram (mcg) one or two inhalation twice daily (BID) for 8 weeks in comparison with FP HFA MDI 50 mcg one or two inhalation BID, in 6-month to 4-year-old Japanese patients with bronchial asthma. The study is also designed to evaluate the safety of long-term treatment of FP/ SLM HFA MDI 50/25 mcg one or two BID for 16 weeks.~The subjects meeting the eligibility criteria will enter the run-in period of 2 weeks and receive FP 50 mcg 1 or 2 inhalation bid (FP 100 or 200 mcg/day), before randomization. The subjects under 2 years of age at Visit 1 will receive only 1 inhalation bid during the run-in period. The subjects who meet the eligibility criteria for randomization will be stratified according to their age (<2 or >=2 year-old) at Visit 1 and randomized to one of the two treatment groups.~The total duration of participation in the study will be 10 weeks for a comparison period completion and 27 weeks for a completion.", - "NCTID": "NCT02113436" - }, - { - "brief_title": "Adaptation of the Pediatric Asthma Control & Communication Instrument (PACCI) in a Pediatric Emergency Department", - "phase": "", - "drugs": "['PACCI-ED use']", - "drugs_list": [ - "PACCI-ED use" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "77.0", - "inclusion_criteria": "inclusion criteria: \n\n Child presented to study institution emergency department during study period \n\n Child was 1 - 17 years-old \n\n Child has physician-diagnosed asthma by parent report \n\n Attending physician for child believed emergency department visit was due to asthma \n\n Attending physician for child completed informed consent and was randomized to PACCI-ED or control group at beginning of study \n\n ", - "exclusion_criteria": ": \n\n Child has major pulmonary or cardiac co-morbid illness \n\n Family of child was non-English speaking \n\n Child was triaged to the med-trauma bay for severe respiratory distress", - "brief_summary": "This study examined whether the Pediatric Asthma Control and Communication Instrument for the Emergency Department (PACCI-ED), a 12-item questionnaire, can help doctors in the emergency department accurately assess a child's asthma control.~This study involved an intervention with the doctors in the emergency department of an urban pediatric hospital. The intervention was done when one of the doctors involved in the study treated a child aged 1-17 years for an asthma exacerbation. Parents answered questions on the PACCI-ED about their children's asthma. Half of the doctors were allowed to see the PACCI-ED results and half were not. The two groups of doctors were compared on their ability to correctly identify asthma control categories, whether a child's asthma was worsening or improving, whether the family was administering controller medications as often as they should, and how much burden the child's asthma was for the family.", - "NCTID": "NCT01895478" - }, - { - "brief_title": "Effect of Montelukast on Basophils, In-vitro", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Allergic Asthma', 'Allergic Rhinitis']", - "diseases_list": [ - "Allergic Asthma", - "Allergic Rhinitis" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria: \n\n Allergic asthma or allergic rhinitis \n\n age 12+ \n\n ", - "exclusion_criteria": ": \n\n smokers", - "brief_summary": "Subjects with either allergic asthma or allergic rhinitis will be recruited to obtain blood. This blood will be used to be stimulated with to whatever the patient allergic. In the laboratory, this stimulated blood will be measured for histamine, leukotrienes, IL-13 and IL-3. These are chemicals responsible for allergy symptoms.", - "NCTID": "NCT00710450" - }, - { - "brief_title": "Inhaled Corticosteroids in U-5 Children With Acute Respiratory Infection in Uganda: A Randomised Trial", - "phase": "Phase 3", - "drugs": "['Inhaled corticosteroid', 'Placebo']", - "drugs_list": [ - "Inhaled corticosteroid", - "Placebo" - ], - "diseases": "['Bacterial Pneumonia', 'Viral Pneumonia', 'Acute Asthma']", - "diseases_list": [ - "Bacterial Pneumonia", - "Viral Pneumonia", - "Acute Asthma" - ], - "enrollment": "1010.0", - "inclusion_criteria": "inclusion criteria: \n\n children aged 2 to 59 months with cough and or difficult breathing \n\n ", - "exclusion_criteria": ": \n\n Presence of a serious concurrent illness such as meningitis, Children with congenital or acquired heart disease Severe anaemia Measles pneumonia Foreign body inhalation A confirmed diagnosis of pulmonary tuberculosis", - "brief_summary": "The purpose of this study is to find out whether adjunct treatment with inhaled corticosteroids lead to faster improvement and reduce mortality of children under 5 years of age admitted to hospital with ALRI.", - "NCTID": "NCT01868113" - }, - { - "brief_title": "Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled LPS", - "phase": "Phase 1; Phase 2", - "drugs": "['Gamma Tocopherol 700 mg capsules,', 'Placebo']", - "drugs_list": [ - "Gamma Tocopherol 700 mg capsules,", - "Placebo" - ], - "diseases": "['Mild, Allergic Asthma']", - "diseases_list": [ - "Mild", - "Allergic Asthma" - ], - "enrollment": "23.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18-50 of both genders \n\n Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy \n\n History of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician diagnosed asthma. \n\n Positive methacholine test. A positive test is defined as a provocative concentration of methacholine of 10 mg/ml or less producing a 20% fall in Forced Expiratory Volume in 1 second (FEV1) (PC20 methacholine) by the method used in a separate screening protocol. \n\n FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70 (without use of bronchodilating medications for 12 hours or long acting beta agonists for 24 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma. \n\n Allergic sensitization to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response. \n\n Symptom Score (this will be submitted as an attachment) no greater than 16 (out of a possible 24) for total symptom score with a value no greater than 3 for any one score. No more than one score may be greater or equal than 3. \n\n subjects must be willing to avoid caffeine for 12 hours prior to all visits. \n\n ", - "exclusion_criteria": ": \n\n Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic infections/immunodeficiency, history of tuberculosis \n\n Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months \n\n Moderate or Severe asthma \n\n Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. \n\n Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current National Heart, Lung and Blood Institute (NHLBI) guidelines for diagnosis and management of asthma. (Not to include prophylactic use of albuterol prior to exercise). \n\n Viral upper respiratory tract infection within 2 weeks of challenge. \n\n Any acute infection requiring antibiotics within 2 weeks of exposure or fever of unknown origin within 2 weeks of challenge. \n\n Severe asthma \n\n Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements. \n\n Medications which may impact the results of the Clinical Center Reference Endotoxin (CCRE) exposure, interfere with any other medications potentially used in the study (to include steroids, beta antagonists, non-steroidal anti-inflammatory agents) \n\n Any history of smoking in the year prior to study enrollment; lifetime smoking history > 10 pack years \n\n Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma \n\n Allergy/sensitivity to study drugs, including E coli, or their formulations. \n\n Known hypersensitivity to methacholine or to other parasympathomimetic agents \n\n History of intubation for asthma \n\n Unwillingness to use reliable contraception if sexually active (Intrauterine device, birth control pills/patch, condoms). \n\n Abnormal Prothrombin Time (PT) or Partial Thromboplastin Time (PTT) values at screening or during the treatment period. Normal values will be those published by the clinical lab (Labcorp, INC). \n\n Any bleeding disorder \n\n Radiation exposure history will be collected. Subjects whose exposure history within the past twelve months would cause them to exceed their annual limits will be excluded. \n\n Pregnancy", - "brief_summary": "To test the hypothesis that gamma tocopherol (vitamin E) supplement inhibits endotoxin induced airways inflammation in allergic asthmatics", - "NCTID": "NCT02104505" - }, - { - "brief_title": "Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART)", - "phase": "Phase 3", - "drugs": "['Vitamin D 3 cholecalciferol', 'Vitamin D3']", - "drugs_list": [ - "Vitamin D 3 cholecalciferol", - "Vitamin D3" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "876.0", - "inclusion_criteria": "inclusion criteria: \n\n Personal history of asthma, eczema, allergic rhinitis or a history of asthma, eczema, allergic rhinitis in the biological father of the child \n\n Gestational age between 10 and 18 weeks at the time of randomization \n\n Maternal age between 18 and 39 years \n\n Not a current smoker \n\n English or Spanish speaking \n\n Intent to participate for the full 4 years (through Pregnancy and then until the 3rd birthday of the child) \n\n ", - "exclusion_criteria": ": \n\n Not meeting inclusion criteria \n\n Gestational age greater than 18 weeks \n\n Presence of chronic medical conditions \n\n Taking vitamin D supplements containing more than 2000 IU/day of vitamin D3 \n\n Multiple gestation pregnancy (twins, triplets) \n\n Pregnancy achieved by assisted reproduction techniques (e.g., IUI, IVF)", - "brief_summary": "Vitamin D supplementation given to pregnant women will prevent asthma in their offspring and children.", - "NCTID": "NCT00920621" - }, - { - "brief_title": "Using the Telephone to Improve Care in Childhood Asthma", - "phase": "", - "drugs": "['Telephone Asthma Program']", - "drugs_list": [ - "Telephone Asthma Program" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "362.0", - "inclusion_criteria": "inclusion criteria: \n\n Physician diagnosis of asthma for at least a year \n\n At least one acute exacerbation of asthma in past 12 months that required a visit to the emergency department, hospitalization or an unscheduled office visit for acute care and/or a course of oral steroids. \n\n Taking daily controller medications or symptoms consistent with persistent asthma \n\n ", - "exclusion_criteria": ": \n\n No phone \n\n Unable to speak English \n\n Child has another disease that requires regular monitoring by pediatrician \n\n A sibling is already enrolled in the study \n\n Child's primary asthma provider is an asthma specialist", - "brief_summary": "Asthma is the most common chronic disease of childhood and a major cause of morbidity in the United States. If asthma symptoms are controlled, a child with asthma can stay well and lead a normal life. Daily use of inhaled steroids controls symptoms and reduces morbidity and emergent health care utilization in children with persistent asthma, and is safe for long-term use. However, inhaled steroids are underused in community asthma care.~The Telephone Asthma Program (TAP) is a series of brief, telephone calls with a trained coach to help the parent manage the child's asthma care. The coach will teach self-management skills, help the parent to use the child's asthma medicines effectively, provide support and remind the parent to go for follow-up care with the pediatrician. We hypothesized that the Telephone Asthma Program will reduce the incidence of acute exacerbations of asthma that require emergent care, improve the quality of life of children with asthma and their parents, and increase the daily use of inhaled steroids in children with persistent asthma. We evaluated the Telephone Asthma Program in a randomized controlled trial involving 362 children aged 5 to 12 years old cared for by community pediatricians. Eligible children were randomized to the TAP program or usual care by their pediatrician.", - "NCTID": "NCT00660322" - }, - { - "brief_title": "Air Cleaners for Children and Adolescents With Asthma and Dog Allergy", - "phase": "", - "drugs": "['IQAir Allergen 100 Air cleaners']", - "drugs_list": [ - "IQAir Allergen 100 Air cleaners" - ], - "diseases": "['Asthma', 'Allergy']", - "diseases_list": [ - "Asthma", - "Allergy" - ], - "enrollment": "22.0", - "inclusion_criteria": "inclusion criteria: \n\n Children and adolescents between 8 and 17 years of age at the start of the trial (born after 01 March '88, but before 01 September '97). \n\n Bronchial asthma, diagnosed by a physician, and confirmed by a physician at a paediatric department of a Norwegian Hospital. \n\n Allergy against dogs, confirmed by skin prick test. Average infiltrate at least 4 millimetres against dog, diagnosed by a new skin prick test at entry. For details about skin prick test, see attachment no. 6. \n\n Having had nose or breathing symptoms by contact with dogs, when no drugs against asthma or allergy have been taken. \n\n Able to co-operate at cold air hyperventilation test and spirometry (see attachment no. 2). \n\n Given written consent (by parents of children below 12; by parents and child when above 12, but below 16; by patient when above 16). \n\n ", - "exclusion_criteria": ": \n\n Positive house dust mite skin prick test, with a more than 3 mm infiltrate. \n\n Having taken oral beta-2-agonists or theophylline preparations for the last 2 weeks before trial start, or oral steroids for the last 3 months before start of the trial. \n\n Active smoking. \n\n Dogs or cats in the home. \n\n Staying away from the home continuously for more than 14 days in the trial period or during the last month before trial start. \n\n Being an in-patient in a special department or institution for asthma and allergy in the trial period or the last 3 months before the trial. \n\n Having another chronic disease that can influence the results of ECP or cold air hyperreactivity tests. \n\n Other types of mechanical ventilation or air filtration systems in the homes, except for those for kitchen stoves.", - "brief_summary": "The purpose is to find out if Icleen IQAir, HEPA-filter air cleaners with high capacity and pre-set speed functions, have a beneficial effect on patients with asthma and allergy to dogs.~Air cleaners will be installed in the bedrooms and living rooms in the homes of children and adolescents aged 8-17 years at the study entry, with allergy to dogs, but not to house dust mites.~The investigators will look upon the significance of this study, and of a previous study with a similar design and the same main parameters to find out if this trial supports the results of the first trial by the same project leader, or makes it likely that the seemingly beneficial effects of the first study occurred by chance.~Main parameters:~hyperventilation cold air challenge test~Supportive parameters:~serum ECP~symptom scores~The trial will be a parallel, double blind placebo controlled one.", - "NCTID": "NCT00220753" - }, - { - "brief_title": "Efficacy of LAMA Added to ICS in Treatment of Asthma", - "phase": "Phase 2", - "drugs": "['CHF 5259 12.5 \u00b5g', 'CHF 5259 placebo']", - "drugs_list": [ - "CHF 5259 12.5 \u00b5g", - "CHF 5259 placebo" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "98.0", - "inclusion_criteria": "inclusion criteria: \n\n History of asthma \u2265 5 years and diagnosed before 40 years old \n\n Uncontrolled asthma on low-medium doses of Inhaled CorticoSteroid (ICS) with ACQ (Asthma Control Questionnaire) \u22651.5 \n\n Pre-bronchodilator FEV1 \u226540% and <90% of their predicted normal value \n\n Positive reversibility test \n\n ", - "exclusion_criteria": ": \n\n Pregnant or lactating women \n\n Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) \n\n Patients treated for asthma exacerbation in the 4 weeks prior to study entry \n\n Patients who are in therapy for gastroesophageal reflux disease \n\n Patients who have a clinically significant cardiovascular condition", - "brief_summary": "The purpose of this study is to evaluate the superiority of the glycopyrrolate bromide (CHF 5259 pMDI) versus placebo on top of QVAR\u00ae pMDI, in terms of lung functions parameters, as well as to assess its safety.", - "NCTID": "NCT02296411" - }, - { - "brief_title": "Salbutamol Tolerance Onset", - "phase": "Phase 4", - "drugs": "['salbutamol', 'Placebo']", - "drugs_list": [ - "salbutamol", - "Placebo" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria: \n\n male or female \n\n 18 to 65 years of age \n\n non smoker \n\n beta agonist naive for at least 14 days \n\n baseline FEV1 at least 70% predicted \n\n no respiratory tract infection or allergen exposure (if atopic) within 4 weeks of visit 1 \n\n ", - "exclusion_criteria": ": \n\n poorly controlled asthma \n\n pregnant or lactating women", - "brief_summary": "Overuse of inhaled bronchodilator beta agonist medication results in a loss of effectiveness (i.e. tolerance). This has been shown for the short acting beta agonist salbutamol and the long acting beta agonist salmeterol. Tolerance to salmeterol is present within 24 hours. The onset of tolerance to salbutamol is not known.", - "NCTID": "NCT01338311" - }, - { - "brief_title": "Thoracic Computed Tomography Scan for Diagnosis of Aspirated Foreign Bodies.", - "phase": "", - "drugs": "['Thoracic CT Scan']", - "drugs_list": [ - "Thoracic CT Scan" - ], - "diseases": "['Aspirated Foreign Body of Lower Respiratory Tract']", - "diseases_list": [ - "Aspirated Foreign Body of Lower Respiratory Tract" - ], - "enrollment": "311.0", - "inclusion_criteria": "inclusion criteria: \n\n age between 6 months and 16 years \n\n suspicion of a foreign body aspiration \n\n health care assurance \n\n information of parents \n\n ", - "exclusion_criteria": ": \n\n emergency situation \n\n certainly of foreign body presence \n\n delay for CT Scan realization longer than 24 hours \n\n no speaking French parents \n\n parents refusal.", - "brief_summary": "To access CT Scan as a diagnostic tool for foreign bodies aspiration.", - "NCTID": "NCT00747981" - }, - { - "brief_title": "Inhaler Lung Deposition in Chronic Obstructive Pulmonary Disease (COPD)", - "phase": "Phase 4", - "drugs": "['SALBUTAMOL']", - "drugs_list": [ - "SALBUTAMOL" - ], - "diseases": "['CHRONIC OBSTRUCTIVE PULMONARY DISEASE', 'ASTHMA', 'HEALTHY SUBJECTS']", - "diseases_list": [ - "CHRONIC OBSTRUCTIVE PULMONARY DISEASE", - "ASTHMA", - "HEALTHY SUBJECTS" - ], - "enrollment": "65.0", - "inclusion_criteria": "inclusion criteria: \n\n - COPD patients, either male or female, over the age of 40 with a clinical diagnosis of COPD with airflow obstruction(FEV1/FVC<0.7) and post-bronchodilator FEV1>50% predicted, gas trapping (on lung volume testing), and decreased carbon monoxide transfer factor. \n\n Healthy subjects will be nonsmokers(or exsmokers stopped 5 years ago), will have no respiratory disease, normal spirometry and be age-matched to the COPD patients. \n\n Asthmatic subjects, either male or female, over the age of 18 with a clinical diagnosis of Asthma with airflow obstruction (FEV1/FVC<0.7). \n\n All patients should be capable of giving informed consent. \n\n ", - "exclusion_criteria": ": \n\n Oral corticosteroids taken within last month. \n\n Current involvement (or involvement in the last 4 weeks)in clinical trials assessing investigational medicinal products. \n\n Previous adverse reaction to short or long acting \u03b22 agonist. \n\n Any subject with a contraindication to taking inhaled beta2-adrenoceptor agonists (especially salbutamol) as listed in the British National Formulary will not be entered into this study. \n\n Those who have experienced an acute respiratory exacerbation requiring emergency room treatment and/ or hospitalisation within four weeks of visit 1 (screening visit). \n\n Pregnant or breastfeeding women. \n\n Subjects unable to give Informed Consent.", - "brief_summary": "Patients with chronic obstructive pulmonary disease (COPD) experience breathing difficulties because the airways deep in their lungs become narrowed. COPD patients use inhaler drugs to provide relief from breathlessness. However, current inhalers are inefficient as they deliver a 'coarse-mist' of drug-droplets that do not reach the deep airways.~In our study, we will use an inhaler of 'fine-mist' drug-droplets, tagged with a radioactive tracer to track them. We will take images of the lungs to see if the fine-mist droplets reach the deep airways, and assess if this improves the breathing capacity in our patients. Our research may allow the development of new, more efficient inhalers to improve treatment for patients with COPD.", - "NCTID": "NCT01721291" - }, - { - "brief_title": "Internet-Based Program to Improve Asthma Management in Children", - "phase": "", - "drugs": "['AsthmaNet']", - "drugs_list": [ - "AsthmaNet" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "600.0", - "inclusion_criteria": "inclusion criteria: \n\n Asthma \n\n Receives asthma care at a clinic in Western Washington \n\n Has access to the internet at home \n\n ", - "exclusion_criteria": ": \n\n Does not speak or read English", - "brief_summary": "Asthma is a respiratory condition that affects millions of children. It can be controlled, however, with the proper medications and treatment. AsthmaNet, an internet-based asthma management system, aims to improve the asthma care of children by providing their parents and doctors with appropriate tools and feedback related to asthma management. The purpose of this study is to evaluate the effectiveness of AsthmaNet at improving quality of care and controlling asthma symptoms in children.", - "NCTID": "NCT00377663" - }, - { - "brief_title": "An Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Asthma", - "phase": "Phase 3", - "drugs": "['fluticasone furoate + vilanterol', 'inhaled corticosteroid with or without a long acting beta2-agonist']", - "drugs_list": [ - "fluticasone furoate + vilanterol", - "inhaled corticosteroid with or without a long acting beta2-agonist" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "4233.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects eligible for enrolment in the study must meet all of the following criteria: \n\n Informed consent: Subjects must be able to provide informed consent, have their consent signed and dated. \n\n Type of subject: Subjects with documented GP diagnosis of asthma as their primary respiratory disease. \n\n Current Anti-Asthma Therapy: All subjects must be prescribed maintenance therapy and receiving ICS with or without LABA (either a fixed combination or via separate inhalers), and for at least 4 weeks prior to Visit 2. \n\n Other background asthma medication such as anti-leukotrienes are permitted \n\n All subjects on ICS monotherapy or ICS/LABA combination (this can be a fixed dose combination or an ICS alone or LABA alone in separate inhalers) must have had symptoms in the past week prior to Visit 2. Symptoms are defined by daytime symptoms more than twice per week, use of short-acting beta2-agonist bronchodilator more than twice per week, any limitation of activities, or any nocturnal symptoms/awakening. (The symptoms are based on subject's recall and are consistent with the GINA and in principal with the BTS/SIGN guidelines). \n\n Subject questionnaires: Subjects must be able to complete the electronic subject questionnaires as well as those questionnaires that are completed by phone or provide a proxy e.g. a partner/relative/a friend who can do so on their behalf \n\n Gender and Age: Male or female subjects aged \u226518 years of age at Visit 1. A female is eligible to enter and participate in the study if she is of: \n\n Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms. However in questionable cases, a blood sample with FSH > 40MIU/ml and estradiol <40pg/ml (<147 pmol/L) is confirmatory. \n\n OR Child bearing potential has a negative urine pregnancy test at Visit 2, and agrees to one of the highly effective and acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - Visit 2 to the end of the study). \n\n ", - "exclusion_criteria": ": \n\n Subjects meeting any of the following criteria must not be enrolled in the study: \n\n Recent history of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 6 months. \n\n COPD Respiratory Disease: A subject must not have current evidence or GP diagnosis of chronic obstructive pulmonary disease. \n\n Other diseases/abnormalities: Subjects with historical or current evidence of uncontrolled or clinically significant disease. Significant is defined as any disease that, in the opinion of the GP/ Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. \n\n Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g., beta2-agonists, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the GP/ Investigator, contraindicates the subject's participation will also be excluded. \n\n Investigational Medications: A subject must not have used any investigational drug within 30 days prior to Visit 2 or within five half-lives (t\u00bd) of the prior investigational study (whichever is longer of the two), (if unsure discuss with the medical monitor prior to screening) \n\n Chronic user of systemic corticosteroids: A subject who, in the opinion of the GP/Investigator, is considered to be a chronic user of systemic corticosteroids for respiratory or other indications (if unsure discuss with the medical monitor prior to screening) \n\n Subjects who are using LABA without an ICS as asthma maintenance therapy. \n\n Subjects who plan to move away from the geographical area where the study is being conducted during the study period and/or if subjects have not consented to their medical records being part of the electronic medical records database that is operational in the Salford area.", - "brief_summary": "This study is designed to compare the effectiveness and safety of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) or 200mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) ) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with the existing asthma maintenance therapy over twelve months in subjects diagnosed with asthma. This is a Phase III multi-centre, randomised open label study. Subjects who meet the eligibility criteria are randomised and will enter a 12 month treatment period.", - "NCTID": "NCT01706198" - }, - { - "brief_title": "Revaccination With Pollinex\u00ae Quattro", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Allergic Rhinitis']", - "diseases_list": [ - "Allergic Rhinitis" - ], - "enrollment": "108.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults and children from the age of 12 years on, who are diagnosed with recurrent seasonal allergic rhinitis (SAR) caused by grass pollen. \n\n A previous specific immunotherapy finished at least five years ago had to be successful. \n\n ", - "exclusion_criteria": ": \n\n Contraindications according to the patient information leaflet", - "brief_summary": "The purpose of this non interventional study (NIS) was to observe the efficacy of Pollinex\u00ae Quattro as a short-term revaccination in patients who have already been successfully desensitized at least five years ago against grass-pollen but developed a recurrent allergy.", - "NCTID": "NCT02579720" - }, - { - "brief_title": "Effect of Flovent Discus vs QVAR vs Pulmicort Flexhaler on Short Term Growth", - "phase": "Phase 4", - "drugs": "['Fluticasone, Budesonide, Beclomethasone', 'Fluticasone, Beclomethasone, Budesonide', 'Budesonide, Fluticasone, Beclomethasone', 'Budesonide, Beclomethasone, Fluticasone', 'Beclomethasone, Fluticasone, Budesonide', 'Beclomethasone, Budesonide, Fluticasone']", - "drugs_list": [ - "Fluticasone", - "Budesonide", - "Beclomethasone", - "Fluticasone", - "Beclomethasone", - "Budesonide", - "Budesonide", - "Fluticasone", - "Beclomethasone", - "Budesonide", - "Beclomethasone", - "Fluticasone", - "Beclomethasone", - "Fluticasone", - "Budesonide", - "Beclomethasone", - "Budesonide", - "Fluticasone" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects will include females (6 to 9 years of age) and males (6 to 11 years of age). \n\n All subjects must have a history of physician diagnosed mild intermittent or mild persistent asthma as documented by PCP medical record or detailed history by study investigator. \n\n All subjects must have a height within normal limits (5th to 95th percentile) and no history of abnormal growth as assessed by medical history. \n\n All subjects must be pre-pubertal (Tanner Stage 1 Sexual Maturity) as assessed by physical examination. \n\n Subjects may be on current treatment with montelukast as this drug does not affect growth. If a subject is on montelukast at screening/baseline, they will remain on a stable dose throughout the study. \n\n Subjects must be willing to comply with study requirements. \n\n ", - "exclusion_criteria": ": \n\n Subjects will be excluded if they have asthma greater than mild persistent severity as defined by NHLBI guidelines. \n\n Subjects will be excluded if they used any systemic or nasal steroids within the past 60 days. \n\n Subjects will be excluded if they had more than one burst of systemic steroids within the past year. \n\n Subjects will be excluded if their baseline FEV1 is < 80% predicted. \n\n Subjects will be excluded if they have any other serious systemic disease other than asthma. \n\n Subjects will be excluded if they have taken any medication known to affect growth i.e. ADHD medications within the past 60 days \n\n Subjects will be excluded if they have a history of allergy to any of the study medications, milk protein or lactose. \n\n Subjects will be excluded if they have active chickenpox or measles or recent exposure to chickenpox or measles. \n\n Subjects will be excluded if they have any history of tuberculosis of the respiratory tract. \n\n Subjects will be excluded if they have any active fungal, bacterial, viral or parasitic infections. \n\n Subjects will be excluded if they have any history of herpes simplex infection of the eye. \n\n Subjects will be excluded if they have taken any immunosuppressive drugs within the past 2 months. \n\n Subjects will be excluded if they have any history of Churg-Strauss syndrome or other eosinophilic disorders. \n\n Subjects will be excluded if an investigator deems they have any mental or development health issues, such as autism, moderate to severe mental retardation or severe ADHD,that interferes with their ability to complete the knemometry measurements. \n\n Subjects will be excluded if an investigator deems they have any physical issues, such as inability to sit independently or amputation of lower leg, that interferes with their ability to complete the knemometry measurements.", - "brief_summary": "Children with mild persistent asthma that have asthma symptoms once or twice a week and use a daily controller, while children with mild intermittent asthma rarely have asthma symptoms and do not use a daily controller. Inhaled corticosteroids are the standard treatment for mild peristent asthma. The purpose of this study is to measure children rate of growth while on different inhaled corticosteroids.", - "NCTID": "NCT01520688" - }, - { - "brief_title": "Double-blind, Multiple Dose Study of Tezepelumab (AMG 157) in Adults With Mild Atopic Asthma", - "phase": "Phase 1", - "drugs": "['Placebo', 'Tezepelumab']", - "drugs_list": [ - "Placebo", - "Tezepelumab" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "31.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female subjects with history of mild atopic asthma between 18 and 60 years-of-age \n\n Body mass index (BMI) between 18 and 35 kg/m^2 \n\n Normal or clinically acceptable physical examination (PE), clinical laboratory values, and electrocardiogram (ECG); clinically acceptable PE includes history of mild atopic asthma \n\n Used only inhaled short-acting \u03b22-agonists infrequently to treat asthma \n\n No current exposure to allergens to which subject experiences asthmatic responses \n\n No other lung disease, exacerbations of asthma or lower respiratory tract infections for at least 6 weeks prior to screening \n\n Positive skin prick test to common aeroallergens at screening \n\n Additional inclusion criteria apply \n\n ", - "exclusion_criteria": ": \n\n History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion; \n\n History or current medical conditions that are contraindicated for methacholine challenge, such as myocardial infarction or stroke within previous 3 months, known cardiac disease, uncontrolled hypertension and aortic or cerebral aneurysm \n\n Evidence of active or suspected bacterial, viral, fungal or parasitic infections within past 6 weeks \n\n Subject has know type I/II diabetes \n\n History of residential exposure to tuberculosis or has a positive purified protein derivative (PPD) or QuantiFERON test within 4 weeks before randomization \n\n Subject who has history of malignancy of any type within 5 years prior to enrollment \n\n Subjects tested positive for drugs/alcohol or nicotine use at screening \n\n Subjects tested positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C \n\n Additional ", - "brief_summary": "The purpose of this study is to assess the late and early asthmatic response after an allergen inhalation challenge in adults with mild atopic asthma after receiving multiple doses of tezepelumab (AMG 157), as well as the safety, tolerability, immunogenicity, and pharmacokinetics of multiple doses of tezepelumab in adults with mild atopic asthma.", - "NCTID": "NCT01405963" - }, - { - "brief_title": "Novel MRI Techniques in the Evaluation of Pulmonary Vascular Disease", - "phase": "Phase 1; Phase 2", - "drugs": "['3-Helium gas']", - "drugs_list": [ - "3-Helium gas" - ], - "diseases": "['Pulmonary Hypertension']", - "diseases_list": [ - "Pulmonary Hypertension" - ], - "enrollment": "9.0", - "inclusion_criteria": "inclusion criteria: \n\n All cases referred to the clinic for assessment for possible pulmonary hypertension. \n\n ", - "exclusion_criteria": ": \n\n patients with a cardiac pacemaker or retained temporary pacing wire \n\n patients with aneurysm clip \n\n non MRI compatible heart valve prosthesis \n\n intra orbital metalic foreign body \n\n pregnancy \n\n metal prosthesis/spinal rods \n\n retained shrapnel \n\n cochlear implants/bladder stimulator", - "brief_summary": "The diagnosis of a patient with pulmonary hypertension (PH) requires many investigations. At present cardiac catheterisation is the cornerstone investigation in these patients where it is used to establish disease severity and estimate prognosis. It is an invasive procedure which is expensive and not without risk to the patient. Despite the multitude of tests performed, identifying those patients with PH who have a poor diagnosis can be difficult. The aim of this study is to improve the assessment of patients with PH using novel magnetic resonance techniques.", - "NCTID": "NCT02026531" - }, - { - "brief_title": "Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm", - "phase": "Phase 4", - "drugs": "['Salbutamol sulfate/Ipratropium bromide', 'Salbutamol']", - "drugs_list": [ - "Salbutamol sulfate/Ipratropium bromide", - "Salbutamol" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female patients with a diagnosis of asthma according to the American Thoracic Society Criteria \n\n Patients aged 7 to 12 years inclusive \n\n Patients able to perform spirometry \n\n Patients with FEV1 (forced expiratory volume in the first second) \u2265 80% of predicted normal value after saline \n\n Patients with PD20 (provocative dose that reduces FEV1 by 20 %) metacholine lower than 8 mg/ml \n\n Patients or responsible relatives willing and able to sign an informed consent form \n\n ", - "exclusion_criteria": ": \n\n Patients on treatment for or suspected as having glaucoma \n\n Patients with known allergy of contra-indications to either salbutamol, ipratropium or their excipients \n\n Patients suspected on clinical grounds to have pneumonia, pneumothorax or pneumomediastinum \n\n Patients with a history of chest surgery \n\n Patients with other respiratory conditions if diagnosed. These include pulmonary fibrosis, bronchiectasis, cystic fibrosis, sarcoidosis, pulmonary tuberculosis, pulmonary complications of AIDS \n\n Patients requiring drugs for the treatment of the acute asthma attack other than the study drugs or oxygen \n\n Patients who have been previously recruited into this study \n\n Patients with myocardiopathy, pulmonary edema or other life threatening diseases, which in the judgement of the pediatrician precludes their entry into the study \n\n Patients with obvious or previously diagnosed serious hepatic or renal disease \n\n Patients who have been under the following drugs within the specified periods of time prior to determination of Baseline FEV1 or metacholine challenge \n\n INHALED: \n\n Short acting \u03b22 agonists: 6 hours \n\n Long acting \u03b22 agonists: 12 hours \n\n Ipratropium bromide: 8 hours \n\n DSCG (disodium cromoglicate): 7 days \n\n Nedocromil: 7 days \n\n ORAL: \n\n Short acting \u03b22 agonists: 18 hours \n\n Anticholinergics: 7 days \n\n Short acting theophylline: 24 hours \n\n Long acting theophylline: 72 hours \n\n Antihistamines: 7 days \n\n Astemizole: 3 months \n\n Ketotifen: 3 months \n\n INHALED or ORAL: Other investigational drugs: 3 months \n\n INHALED or ORAL: Corticosteroids: 30 days", - "brief_summary": "The purpose of this study was to evaluate whether 2 puffs of fixed combination of aerosolized 120 mcg salbutamol sulphate (equivalent to 100 mcg of the base) + 20 mcg ipratropium bromide confers significant additional protection against metacholine induced bronchoconstriction in asthmatic atopic patients when compared to 2 puffs of aerosolized 100 mcg salbutamol alone.", - "NCTID": "NCT02182713" - }, - { - "brief_title": "School-Based Preventive Asthma Care Technology: A Trial Using a Novel Technology to Improve Adherence", - "phase": "", - "drugs": "['School-Based Medication Delivery']", - "drugs_list": [ - "School-Based Medication Delivery" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "99.0", - "inclusion_criteria": "inclusion criteria (all 4 criteria must be met): \n\n Physician-diagnosed asthma (based on parent report). \n\n Persistent asthma (criteria based on NHLBI guidelines). Any 1 of the following: \n\n An average of >2 days per week with asthma symptoms \n\n >2 days per week with rescue medication use \n\n >2 days per month with nighttime symptoms \n\n \u22652 episodes of asthma during the past year that have required systemic corticosteroids \n\n Age \u22653 and \u226410 years. \n\n Attending school in participating Rochester City School District preschools or elementary schools. \n\n ", - "exclusion_criteria": ": \n\n Inability to speak and understand English. (*Parents unable to read will be eligible, and all instruments will be given verbally.) \n\n No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible alternate phone number). \n\n Family planning to leave the school district within fewer than 6 months. \n\n The child having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures. \n\n Children in foster care or other situations in which consent cannot be obtained from a guardian.", - "brief_summary": "The goal of this new translational project is to test the feasibility and effectiveness of implementing school-based directly observed therapy of preventive asthma medications in a real-world setting, using state-of-the-art web-based technology for systematic screening, electronic report generation, and communication between nurses, caregivers, and primary care providers. With the use of a novel method to improve adherence and subsequently reduce morbidity, the investigators hypothesize that this novel adaptation of school-based asthma care will; 1) be feasible and acceptable among this population and among school and community stakeholders, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and emergency room / urgent care use for asthma care). The investigators anticipate that enhancing preventive healthcare for young urban children with asthma through partnerships with the schools using a novel technology will yield improved health, prevention of suffering, decreased absenteeism from school, and reduced healthcare costs.", - "NCTID": "NCT01175434" - }, - { - "brief_title": "Triple in Asthma Dose Finding", - "phase": "Phase 2", - "drugs": "['CHF 5259 plus Foster 100/6 \u00b5g', 'Foster 100/6 \u00b5g']", - "drugs_list": [ - "CHF 5259 plus Foster 100/6 \u00b5g", - "Foster 100/6 \u00b5g" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "211.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female patients aged >=18 years \n\n Uncontrolled asthma on medium doses of ICS+LABA with ACQ >=1.5 \n\n Pre-bronchodilator FEV1 \u226540% and <80% of their predicted normal value \n\n ", - "exclusion_criteria": ": \n\n Pregnant or lactating women \n\n Diagnosis of COPD \n\n Patients treated for asthma exacerbations in the 4 weeks prior to study entry \n\n Patients who are in therapy for gastroesophageal reflux disease \n\n Patients who have a clinically significant cardiovascular condition", - "brief_summary": "The purpose of this study is to determine the optimal dose of CHF 5259 (glycopyrrolate bromide) on top of Foster which provides the optimal additive bronchodilator effect to asthmatic patients whose symptoms are uncontrolled with medium dose of inhaled corticosteroids plus long acting beta2 agonists.", - "NCTID": "NCT02127866" - }, - { - "brief_title": "Clinical Study to Evaluate the Efficacy and Safety of VR506 Using a New Inhaler for the Treatment of Asthma", - "phase": "Phase 2; Phase 3", - "drugs": "['VR506']", - "drugs_list": [ - "VR506" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "197.0", - "inclusion_criteria": "Inclusion: \n\n Written informed consent \n\n Adolescents aged 12-17 years & adults aged 18-65 years (both inclusive) \n\n Documented clinical history of severe asthma requiring prednisone/prednisolone therapy, high-intensity treatment ICS, OCS, LABA \n\n Stable OCS dose for \u22657 days before Screening Visit & during Screening Period. \n\n At least 80% compliant w/regular asthma medication per investigator at end of Screening Period \n\n Documented asthma reversibility within 5 yrs prior to/during Screening Period, or diagnosis of asthma that is incontrovertible per investigator \n\n Ability to use nDPI correctly, per investigator's review of completed inhaler operation checklist \n\n Ability to use eDiary correctly, assessed by investigator at end of Screening Period \n\n Ability to comply w/study procedures, including blood sampling \n\n Ability to perform technically satisfactory pulmonary function tests \n\n Available to complete all study visits before 12 noon \n\n BMI of 16-26 kg/m2 in adolescents and 18-32 kg/m2 in adults \n\n Oral PIF \u226540 L/min, using an appropriate device set to match resistance of inhaler \n\n Good health, except for presence of asthma, per medical history/physical examination \n\n Negative drug/alcohol/urine cotinine screen. Subjects must test negative for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, cotinine, ethanol & opiates (unless given as prescription medicine) \n\n Non-smokers or ex-smokers with a smoking history of less than 10 pack-yrs (e.g. <20 cigarettes per day for 10 years or <40 cigarettes per day for 5 years) & stopped smoking for at least 1 year prior to Screening Visit. Smoking will not be permitted throughout study \n\n Female subjects of child-bearing potential must be using medically acceptable forms of contraception [abstinence, hormonal (oral/implant/transdermal/injection), in use for \u22653 consecutive months before first dose of study medication, double barrier (condom w/spermicide, or diaphragm w/spermicide), IUD, or vasectomised partner (\u22656 months since vasectomy)]. \n\n Exclusion: \n\n Regular use (\u22653 times/wk) of topical steroids to treat dermatitis/rhinitis/allergic conjunctivitis, within 28 days of Screening Visit \n\n Subjects who have/who have had, an upper/lower respiratory tract infection within 28 days of Screening Visit \n\n Subjects w/brittle asthma \n\n Subjects w/asthma that required admission to an ICU and/or ventilation within previous 12 months \n\n Subjects whose comorbidities, per investigator's opinion, are major contributors to their respiratory symptoms (e.g. COPD, bronchiectasis, dysfunctional breathlessness, vocal cord dysfunction, gastro-oesophageal reflux) \n\n Previously/currently diagnosed as having Churg-Strauss syndrome \n\n Previously/currently diagnosed as having pulmonary eosinophilia \n\n History of lung cancer \n\n Subjects w/current diagnosis of HIV infection \n\n Active chronic hepatitis B or C infection \n\n Subjects who have clinically significant abnormality/finding from examination, tests, or history that may compromise subject safety, specifically any history of cardiac, renal or hepatic impairment \n\n Subjects with an abnormal ECG \n\n Persistent arterial hypotension, with average SBP readings of \u226495 mmHg \n\n Persistent elevation of blood pressure, with average SBP readings of \u2265160 mmHg or average DBP readings of \u2265100 mmHg \n\n Pregnant or lactating females \n\n Participation in another clinical study in 28 days prior to Screening Visit \n\n Evidence of clinically significant renal, hepatic, cardiac, pulmonary (apart from asthma) or metabolic dysfunction, e.g. diabetes mellitus, thyrotoxicosis, uncorrectable hypokalaemia, or predisposition to low levels of serum potassium \n\n Current/history of drug/alcohol abuse/dependence per WHO criteria \n\n Inability to communicate well w/investigator \n\n Donation of \u2265450 mL of blood/blood products within previous 3 months prior to screening \n\n History of allergy/intolerance/contraindications to corticosteroids/lactose, or severe allergy to milk proteins \n\n Consumption of alcohol- or caffeine-containing foods/beverages from midnight before or during Screening Visit \n\n History of medically diagnosed chronic respiratory diseases other than asthma (e.g. chronic obstructive pulmonary disease, ABPA in the absence of asthma)", - "exclusion_criteria": "", - "brief_summary": "To evaluate the clinical efficacy, safety, tolerability and dose-response relationship, using oral corticosteroid (OCS) modulation, of 3 different doses of VR506 using a twice daily regimen from a new dry powder inhaler (nDPI) for 16 weeks in subjects with severe persistent asthma requiring OCS therapy, i.e. Step 5 treatment as defined by modified Global Initiative for Asthma (GINA) guidelines 2011.", - "NCTID": "NCT01720069" - }, - { - "brief_title": "HealthSpark 2: Improving Asthma Care for Preschool Children", - "phase": "", - "drugs": "['Asthma education']", - "drugs_list": [ - "Asthma education" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "2000.0", - "inclusion_criteria": "inclusion criteria: \n\n Children ages 1 - 5 years, enrolled in one of the designated SPARK child care centers \n\n ", - "exclusion_criteria": ": \n\n Children under the age of 1 year \n\n Children whose parents do not want to participate \n\n Children whose child care centers do not want to participate", - "brief_summary": "From a previous community needs survey, we determined that asthma was a particular problem in our community-based research network of child care centers. This study will examine whether a moderate intervention can help these centers improve their asthma-friendly rating as per NHLBI guidelines. We will both center directors and parents to establish baseline data on child health and the asthma-friendliness of each center. We will use a wait-list control, with all centers eventually receiving the intervention.", - "NCTID": "NCT00304304" - }, - { - "brief_title": "CDC Medicaid Asthma Home Visit Project", - "phase": "", - "drugs": "['CHW intervention']", - "drugs_list": [ - "CHW intervention" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "373.0", - "inclusion_criteria": "inclusion criteria: \n\n caretaker is age 18 or older and child is age 3-17 \n\n have not controlled as thma \n\n residence in King County \n\n spoken language is English or Spanish \n\n Child is enrolled in a Medicaid managed care health plan offered by Community Health Plan of Washington (CHPW) or Molina Health Plan of Washington, Inc (Molina). \n\n ", - "exclusion_criteria": ": \n\n Parent/guardian plans to move out of King County within the next year or lacks permanent housing. \n\n Parent/guardian has a mental or physical disability making it impossible to participate in the protocols. \n\n The household appears to be unsafe for visitation by the CHW. \n\n The child has other serious chronic medical conditions (e.g. poorly controlled sickle cell disease, cystic fibrosis) that cause sufficient limitation in functional status so that that asthma control is not a priority. \n\n The family is enrolled in another asthma research study within the past three years. This is to avoid the potential confounding effect from other studies. \n\n The child is in foster care or group care settings.", - "brief_summary": "Asthmatic children age 3-17 from low income households in King County are randomly assigned into a community health worker (CHW) intervention group and a control group. The intervention is in-home education and support related to asthma self-management. The main outcome measures are asthma symptom-free days, caretaker's asthma-related quality of life score, and health care utilization for asthma measured at baseline and 12 months after baseline enrollment.", - "NCTID": "NCT02258308" - }, - { - "brief_title": "An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol 100/25 Microgram (mcg) Inhalation Powder, Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Fluticasone Propionate 250 mcg Inhalation Powder in Adults and Adolescents With Persistent Asthma", - "phase": "Phase 3", - "drugs": "['Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler', 'Placebo inhalation powders via ELLIPTA inhaler', 'Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler', 'Placebo inhalation powder via ACCUHALER/DISKUS inhaler', 'Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler']", - "drugs_list": [ - "Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler", - "Placebo inhalation powders via ELLIPTA inhaler", - "Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler", - "Placebo inhalation powder via ACCUHALER/DISKUS inhaler", - "Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "1526.0", - "inclusion_criteria": "inclusion criteria \n\n Subjects must give their signed and dated written informed consent to participate prior to commencing any study related activities. \n\n Subjects must be outpatients >=12 years of age at Visit 1 who have had a diagnosis of asthma, as defined by the National Institutes of Health, for at least 12 weeks prior to Visit 1 (Note: Countries with local restrictions prohibiting enrollment of adolescents will enroll subjects >=18 years of age only). \n\n Subjects may be male or an eligible female. An eligible female is defined as having non-childbearing potential or having childbearing potential and a negative urine pregnancy test at Screening and agrees to use an acceptable method of birth control consistently and correctly. \n\n Subjects must have a FEV1 of >=80% of the predicted normal value. \n\n Subjects are eligible if they have received mid dose ICS plus LABA (equivalent to FP/salmeterol 250/50 twice daily or an equivalent combination via separate inhalers) for at least the 12 weeks immediately preceding Visit 1. \n\n All subjects must be able to replace their current SABA treatment with albuterol/salbutamol aerosol inhaler at Visit 1 for use, as needed, for the duration of the study. Subjects must be able to withhold albuterol/salbutamol for at least 6 hours prior to study visits. \n\n If in the opinion of the investigator the subject's asthma is well controlled. ", - "exclusion_criteria": " \n\n History of Life-Threatening Asthma, defined for this protocol as an asthma episode that required intubation and/or associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 5 years. \n\n Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management or in the opinion of the Investigator, expected to affect the subject's asthma status or the subject's ability to participate in the study. \n\n Any asthma exacerbation requiring oral corticosteroids within 12 weeks of Visit 1 or resulting in an overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1. \n\n A subject must not have current evidence of Atlectasis, Bronchopulmonary dysplasia, Chronic bronchitis, Chronic obstructive pulmonary disease, Pneumonia, Pneumothorax, Interstitial lung disease, or any evidence of concurrent respiratory disease other than asthma \n\n A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study. \n\n A subject must not have used any investigational drug within 30 days prior to Visit 1 or within five half-lives (t\u00bd) of the prior investigational study, whichever is longer of the two. \n\n Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of RELVAR\u2122 ELLIPTA inhaler, SERETIDE\u2122 ACCUHALER/DISKUS inhaler or FP 250. \n\n History of severe milk protein allergy. \n\n Administration of prescription or non-prescription medication that would significantly affect the course of asthma, or interact with study drug. \n\n A subject must not be using or require the use of immunosuppressive medications during the study. \n\n A subject will not be eligible if he/she or his/her parent or legal guardian has any infirmity, disability, disease, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol, including visit schedule and completion of the daily diaries. \n\n Current tobacco smoker or has a smoking history of 10 pack-years (20 cigarettes/day for 10 years). A subject may not have used inhaled tobacco products or inhaled marijuana within the past 3 months (e.g., cigarettes, cigars, electronic cigarettes, or pipe tobacco). \n\n A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.", - "brief_summary": "This study is a randomized, double-blind, double-dummy, parallel group, multicenter, non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are currently receiving mid dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist (LABA) (equivalent to fluticasone propionate [FP]/salmeterol 250/50 microgram [mcg]twice daily [BD]), either via a fixed dose combination product or through separate inhalers. The study consists of a LABA washout period of 5 days and a run-in period of 4 weeks, followed by a treatment period of 24 weeks, and a follow up contact period of one week. The total duration of the study is 30 weeks. Approximately 1461 subjects will be randomized to one of the following three treatments (487 per treatment): fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg once daily (OD) in the evening (PM) via ELLIPTA\u2122 inhaler plus placebo BD via ACCUHALER\u2122/DISKUS\u2122; FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler; FP 250 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler. In addition, all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms. This study will determine if FF/VI 100/25 mcg OD via ELLIPTA inhaler is non-inferior to FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler in adult and adolescent asthmatic subjects already adequately controlled on a twice-daily ICS/LABA.~SERETIDE, ELLIPTA, ACCUHALER, RELVAR, and DISKUS are trademarks of the GlaxoSmithKline Group of Companies.", - "NCTID": "NCT02301975" - }, - { - "brief_title": "The Effects of RPL554 on Top of Standard COPD Reliever Medications", - "phase": "Phase 2", - "drugs": "['Salbutamol', 'Ipratropium', 'RPL554', 'Salbutamol matched placebo', 'Ipratropium matched placebo', 'RPL554 matched placebo']", - "drugs_list": [ - "Salbutamol", - "Ipratropium", - "RPL554", - "Salbutamol matched placebo", - "Ipratropium matched placebo", - "RPL554 matched placebo" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "36.0", - "inclusion_criteria": "inclusion criteria: \n\n Provide informed consent \n\n Males not donating sperm and using adequate contraception or females who are surgically sterile or postmenopausal \n\n 12-lead ECG showing:Heart rate 45 to 90 bpm, QTcF\u2264450 msec, QRS \u2264120 msec, PR interval \u2264220 msec, no clinically significant abnormality \n\n Capable of complying with all study restrictions and procedures including ability to use the study nebuliser correctly. \n\n BMI 18 to 33 kg/m2 with a minimum weight of 45 kg. \n\n COPD diagnosis for at least 1 year and clinically stable COPD in previous 4 weeks \n\n Demonstrates reversibility to bronchodilator (two puffs of salbutamol followed by two puffs of ipratropium) via spirometry: \n\n Post-bronchodilator FEV1/forced vital capacity (FVC) ratio of \u22640.70 \n\n Post-bronchodilator FEV1 \u226540 % and \u226480% of predicted normal \n\n \u2265150 mL increase from pre-bronchodilator FEV1 \n\n Chest X-ray showing no abnormalities \n\n Meet the concomitant medication restrictions and be expected to do so for the rest of the study. \n\n Smoking history of \u226510 pack years. \n\n Capable of withdrawing from long acting bronchodilators throughout the study and short acting bronchodilators for 8 hours prior to study treatment. \n\n ", - "exclusion_criteria": ": \n\n History of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation. \n\n COPD exacerbation requiring oral steroids in the previous 3 months \n\n History of one or more hospitalisations for COPD in the previous 12 months \n\n Respiratory tract infection (both upper and lower) treated with antibiotics in previous 12 weeks \n\n Evidence of cor pulmonale or clinically significant pulmonary hypertension. \n\n Other respiratory disorders \n\n Previous lung resection or lung reduction surgery. \n\n Oral therapies for COPD in the previous 3 months and throughout the study. \n\n Drug or alcohol abuse in the past 3 years \n\n Received an experimental drug within 3 months or five half lives, whichever is longer. \n\n Prior exposure to RPL554 \n\n Patients with a history of chronic uncontrolled disease that the Investigator believes are clinically significant. \n\n Documented cardiovascular disease in last 3 months \n\n Major surgery, (requiring general anaesthesia) in the previous 6 weeks, or will not have fully recovered from surgery, or planned surgery through the end of the study. \n\n History of malignancy of any organ system within 5 years with the exception of localised skin cancers (basal or squamous cell) \n\n Clinically significant abnormal values for safety laboratory tests \n\n A disclosed history, or one known to the Investigator, of significant non compliance in previous investigational studies or with prescribed medications. \n\n Requires oxygen therapy, even on an occasional basis. \n\n Inability to adequately perform whole body plethysmography. \n\n Any other reason that the Investigator considers makes the subject unsuitable to participate. \n\n Patients with known hypersensitivity to atropine or its derivatives, or to ipratropium bromide, salbutamol or RPL554 or their excipients/components.", - "brief_summary": "This study evaluates the addition of RPL554 to standard reliever medications for chronic obstructive pulmonary disorder (COPD). All patients will receive the same six treatments in a randomised sequence:~salbutamol,~ipratropium,~salbutamol + RPL554,~ipratropium + RPL554,~RPL554~Placebo", - "NCTID": "NCT02542254" - }, - { - "brief_title": "Ipratropium or Salbutamol Sulphate Alone or Combination Therapy Salbutamol and Ipratropium in Patients With COPD", - "phase": "Phase 4", - "drugs": "['Ipratropium bromide 500 \u00b5g/salbutamol sulphate 3 mg', 'Ipratropium 500 \u00b5g', 'Salbutamol sulphate 3 mg', 'Salbutamol sulphate 6 mg']", - "drugs_list": [ - "Ipratropium bromide 500 \u00b5g/salbutamol sulphate 3 mg", - "Ipratropium 500 \u00b5g", - "Salbutamol sulphate 3 mg", - "Salbutamol sulphate 6 mg" - ], - "diseases": "['Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "33.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female patients with moderate to severe stable COPD: \n\n Patients with a diagnosis of chronic bronchitis and/or emphysema \n\n FEV1 <65% of predicted value without regard to prior treatment \n\n Forced expiratory ration (FER = FEV1/VC) <70% of predicted value without regard to prior treatment \n\n Patients must not have had a respiratory infection or an exacerbation of COPD during the four weeks immediately prior to entering the trial \n\n Patients must not have changed their normal treatment for COPD during the four weeks immediately prior to entering the trial \n\n Patient aged \u226540 years \n\n Patients with a smoking history of \u226515 pack-years \n\n Patients must have given informed consent to participate in the trial \n\n ", - "exclusion_criteria": ": \n\n Patients with a diagnosis of asthma, bronchiectasis, cystic fibrosis or bronchiolitis obliterans \n\n Patients with any of the following: \n\n untreated angle closure glaucoma \n\n hypertrophic obstructive cardiomyopathy \n\n tachyarrhythmia \n\n recent myocardial infarction (within six months of screening visit) \n\n severe organic cardiac or vascular disorder \n\n untreated hyperthyroidism \n\n diabetes mellitus (after approval of Protocol Amendment 1, the inclusion of well controlled diabetic patients was allowed) \n\n Patients who are pregnant, or who are planning a pregnancy, and nursing mothers \n\n Patients known to be hypersensitive to anticholinergic drugs or to \u03b22 agonists \n\n Patients known to abuse drugs or alcohol \n\n Patients, who in the opinion of the investigator, are likely not to co-operate with any of the requirements of the trial \n\n Patients with a PaO2 (arterial carbon dioxide tension) <56 mmHg (7.5 kPa) at rest while breathing air without regard to prior treatment \n\n Patients with a SaO2 \u226485% at rest while breathing air without regard to prior treatment \n\n Patients who are taking part in another investigation, and patients who have participated in another clinical trial during the three months immediately preceding entry to this trial \n\n Patients on home oxygen concentrator therapy \n\n Patients who have previously participated in the randomised phase of this trial", - "brief_summary": "Study to compare the effects of nebulised salbutamol or ipratropium alone in patients with COPD with those of combined salbutamol and ipratropium nebuliser solution on arterial oxygen saturation (SaO2) and to characterise patients with COPD (chronic obstructive pulmonary disease) at risk of significant arterial oxygen desaturation following nebulised salbutamol.", - "NCTID": "NCT02182856" - }, - { - "brief_title": "Study of Brain Blood Flow During Induced Hypercapnia (Excess Blood Carbon Dioxide)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Healthy', 'Hypercapnia']", - "diseases_list": [ - "Healthy", - "Hypercapnia" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Any normal volunteer above the age of 18 years old who is capable of giving informed consent. \n\n ", - "exclusion_criteria": ": \n\n Subjects will be excluded if they have contraindications to MR scanning, such as the following: aneurism clip, implanted neural stimulator, implanted cardiac pacemaker or autodefibrillator, chochlear implant, ocular foreign body (e.g., metal shavings), or insulin pump. Also, subjects will be excluded if they have panic disorder or migrane (because of possible complications with CO2 inhilation), or if they have cirrhosis, are on high dose aspirin therapy, or have an allergy to acetazolamide injection). Subjects will be excluded if they have allergies to sulfonamide drugs or if they have a chronic respiratory illness.", - "brief_summary": "This study will evaluate magnetic resonance imaging (MRI ) methods for measuring changes in the brain's blood flow during hypercapnia (a condition of excess carbon dioxide in the blood). MRI is a diagnostic tool that uses a large magnet and radio waves to produce images of the body without X-rays.~Healthy normal volunteers in this study may have as many as six MRI scans over a 2-year period. For this procedure, the person lies on a stretcher placed in a strong magnetic field produced by the MRI machine. During the scan, the person's blood carbon dioxide (CO2 ) levels will be increased either by: 1) breathing air mixtures containing up to 5% CO2; or 2) receiving an intravenous (I.V.) injection of a drug called acetazolamide.~Persons who breathe CO2 will have their heart rate, blood pressure and oxygen levels monitored throughout the procedure. Those receiving acetazolamide will have the drug injected intravenously (I.V.) into an arm vein. If the volunteer experiences any unpleasant side effects from the CO2 or acetazolamide, the study will be stopped.~The information gained from this study will be used to develop better ways to study brain function, possibly leading to better diagnostic and treatment methods.", - "NCTID": "NCT00001845" - } - ], - "1": [ - { - "brief_title": "Childhood Asthma and Schooling: The Truth Unveiled", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Bronchial Asthma']", - "diseases_list": [ - "Bronchial Asthma" - ], - "enrollment": "450.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of bronchial asthma \n\n Must be able to swallow tablets \n\n ", - "exclusion_criteria": ": \n\n Steroid inhalation or ingestion", - "brief_summary": "Childhood Asthma and Schooling: The Truth Unveiled.", - "NCTID": "NCT00930826" - }, - { - "brief_title": "A Study of Inhalation of 20,000 EU CCRE in Normal Volunteers Compared to Allergic Asthmatic Individuals", - "phase": "Phase 1", - "drugs": "['Clinical Center Reference Endotoxin (CCRE)', 'Clinical Center Reference Endotoxin (CCRE)']", - "drugs_list": [ - "Clinical Center Reference Endotoxin (CCRE)", - "Clinical Center Reference Endotoxin (CCRE)" - ], - "diseases": "['Asthma', 'Hypersensitivity']", - "diseases_list": [ - "Asthma", - "Hypersensitivity" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria for healthy controls: \n\n Normal lung function, defined as (Knudson 1976/1984 predicted set): \n\n FVC of > 80 % of that predicted for gender, ethnicity, age and height FEV1 of > 80 % of that predicted for gender, ethnicity, age and height FEV1/FVC ratio of > .75 \n\n Oxygen saturation of > 94 % and normal blood pressure (Systolic between 150 - 90, Diastolic between 90-60 mm Hg) \n\n Symptom Score no greater than 6 (out of a possible 24) for total symptom score with a value no greater than 2 for any one score. \n\n Negative methacholine inhalation challenge as performed in the screening protocol. (Less than a 20% decrease in FEV1 at a maximum methacholine concentration of 10 mg/ml) \n\n --Negative pregnancy test for females \n\n Negative allergy skin test (AST) \n\n inclusion criteria for allergic asthmatics also include: \n\n History of episodic wheezing, chest tightness, or shortness of breath after age of 6 years consistent with asthma, or physician diagnosed asthma after age of 6 years. \n\n Positive methacholine test. \n\n FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70 (without use of bronchodilating medications for 12 hours) \n\n Allergic sensitization to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive AST. \n\n Negative allergy skin test as performed in the screening protocol. \n\n ", - "exclusion_criteria": ": \n\n Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, or chronic thyroid disease. \n\n Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months. \n\n Use of systemic steroid therapy within the preceding 12 months for an asthma exacerbation. All use of systemic steroids in the last year will be reviewed by a study physician. \n\n Use of inhaled steroids, cromolyn or leukotriene inhibitors (montelukast or zafirlukast) except for use of cromolyn exclusively prior to exercise. \n\n Use of daily theophylline within the past month. \n\n Use of tricyclics and MAO inhibitors \n\n Pregnancy or nursing a baby. \n\n Cigarette smoking > 1 pack per month. \n\n Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. \n\n Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. \n\n Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to include prophylactic use of albuterol prior to exercise). \n\n Viral upper respiratory tract infection within 2 weeks of challenge. \n\n Any acute infection requiring antibiotics within 2 weeks of challenge \n\n Receipt of LAIV (Live Attenuated Influenza Vaccine), also know as FluMist\u00ae, within the prior 14 days", - "brief_summary": "This will be a single center, open label study comparing baseline characteristics of recovered sputum cells (collected on screening day) to those of cells recovered 6 hours after inhalational challenge with 20,000 EU Clinical Center Reference Endotoxin (CCRE, a component of air pollution)) within each group as well as cross group comparisons between individuals with allergic asthma (AA's)and normal volunteers (NV's). The primary objective of this study is to test the hypothesis that persons with allergic asthma will have an increased neutrophil response to challenge with 20,000 EU CCRE compared to normal volunteers. Secondary objectives include post CCRE comparison between AA's and NV's with regard to changes in airway cells and blood as well as changes in mucociliary clearance (MCC) in response to inhalation of 20,000 EU CCRE.", - "NCTID": "NCT00839124" - }, - { - "brief_title": "Effect of Ozone on Airway Inflammation in Allergic Asthmatics Treated With Omalizumab", - "phase": "", - "drugs": "['omalizumab']", - "drugs_list": [ - "omalizumab" - ], - "diseases": "['Asthma', 'Allergy']", - "diseases_list": [ - "Asthma", - "Allergy" - ], - "enrollment": "1.0", - "inclusion_criteria": "inclusion criteria: \n\n Normal lung function, defined as (Knudson 1976/1984 predicted set): \n\n FVC of > 80 % of that predicted for gender, ethnicity, age and height \n\n FEV1 of > 80 % of that predicted for gender, ethnicity, age and height \n\n FEV1/FVC ratio of > 80 % of predicted values \n\n Evidence of allergy to house dust mite \n\n Oxygen saturation of > 94 % \n\n Normal blood pressure (Systolic between 150 - 90, Diastolic between 90-60 mm Hg) \n\n Symptom Score (defined in section f) no greater than 20 (out of a possible 60) for total symptom score with a value no greater than 3 for any one score. No more than one score may be greater or equal than 3. \n\n IgE within the following ranges and body weights for omalizumab dosing: IgE \u226530-700 int. units/mL, and weight 30-90 kg. \n\n ", - "exclusion_criteria": ": \n\n A history of significant chronic illnesses (to include diabetes, autoimmune diseases, immunodeficiency state, known ischemic heart disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or severe asthma, hypertension) \n\n Allergy to any medications which may be used in the course of this study (albuterol, acetaminophen, aspirin or non-steroidal anti-inflammatory agents, corticosteroids, lactose, polyethylene glycol) \n\n Positive pregnancy test at time of initial screening \n\n Medications which may impact the results of the ozone challenge, interfere with any other medications potentially used in the study (to include steroids, beta antagonists, non-steroidal anti-inflammatory agents) or suggest an ongoing illness (such as antibiotics) \n\n Mega doses of vitamins and supplements, homeopathic/naturopathic medicines \n\n Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally resolved symptomatically for 2 weeks. Documentation of normal lung function (as defined in Specific inclusion criteria) must be met. \n\n Unspecified illnesses, which in the judgment of the investigator increase the risk associated with ozone inhalation challenge, will be a basis for exclusion. \n\n Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months. \n\n Use of systemic steroid therapy within the preceding 12 months. \n\n Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or zafirkulast) initiated within the past month (except for use of cromolyn exclusively prior to exercise). Patients must be on a stable regimen of therapy and shown to be stable. \n\n Use of daily theophylline within the past month. \n\n Pregnancy or nursing a baby. \n\n Cigarette smoking > 1 pack per month. \n\n Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. \n\n Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. \n\n Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to include prophylactic use of albuterol prior to exercise). \n\n Dosing level of an inhaled steroid must be consistent with mild episodic asthma as outlined by the NHLBI NAEPP guidelines. Any dose of inhaled steroid typically used for moderate or severe asthma will result in exclusion from the protocol.", - "brief_summary": "Ozone can cause acute airway inflammation in both asthmatics and normal volunteers. However, in asthmatics ozone can cause episodes of worsening of asthma. We want to learn if chronic allergic response, known as IgE-induced airway inflammation is what causes the increased inflammation in response to ozone. To do this we will examine the response to ozone in a group of asthmatics treated with omalizumab, a medicine available and approved for use in people with asthma, or a placebo control. The placebo for this study is inert physiologic saline (salt water) which contains no omalizumab. Both the omalizumab and the placebo will be administered as an injection under the skin. Omalizumab, also called Xolair, is a humanized monoclonal antibody, which means that it originally was produced in mice, then genetically engineered to look more like human than mouse antibody. Omalizumab inactivates IgE, a protein our own immune systems make as part of allergic reactions. The purpose of this study is to test the hypothesis that omalizumab, by blocking this aspect of allergic reactions, will decrease the number of inflammatory cells in the airway after ozone challenge. We also hypothesize that omalizumab will decrease the effects of ozone on changes in lung function, mucociliary clearance (a measure of how quickly mucus clears form the airway) and airway reactivity. Airway reactivity is a measure of how sensitive the airways are to a medication used to diagnose asthma, called methacholine. We will examine these as additional information we can learn during the course of the study. This is a blinded study, meaning that neither you nor the researchers know if you get the active drug or placebo, but that information can be obtained if needed. The placebo is an injection of inert physiological saline (salt water) which contains no omalizumab.", - "NCTID": "NCT00287378" - } - ], - "2": [ - { - "brief_title": "Viral Inception of Asthma: Prospective Study From Infancy to School-age", - "phase": "", - "drugs": "['prednisolone']", - "drugs_list": [ - "prednisolone" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n age 3-23 months \n\n be delivered at >=37 weeks \n\n first wheezing episode \n\n written informed consent from guardian \n\n ", - "exclusion_criteria": ": \n\n chronic illness other than atopy \n\n previous systemic or inhaled corticosteroid treatment \n\n participation to another study \n\n varicella contact if previously intact \n\n need for intensive care unit treatment, or \n\n poor understanding of Finnish", - "brief_summary": "The purpose of this study is to study prospectively the early clinical and immunological events in children susceptible to rhinovirus induced early wheezing (i.e., recently found highest risk factor for recurrent wheezing/asthma) and the efficacy of systemic corticosteroid to modify these events.~Up to 50% of children suffer from acute wheezing before school-age. The prevalence of childhood asthma is 5-7%. Although pediatric asthma is mainly allergic, the exacerbations are associated with respiratory viral infections in 95% of cases. The means to predict asthma from environmental factors have been limited mainly to sensitization to aeroallergens (3-fold risk), which start to develop usually at 2-3 years of age. VINKU 1-study (orig. VINKU-study) discovered simultaneously with two other groups, that early wheezing associated with rhinovirus, the common cold virus, is the strongest predictor of recurrent wheezing/asthma (up to 10-fold risky). Noteworthily, viral infections work as risk markers already during infancy, a lot earlier than the sensitization to aeroallergens. The investigators also found retrospectively that early wheezers affected by rhinovirus responded to 3 day course of oral prednisolone (inexpensive and widely available treatment): recurrent wheezing decreased by 50% during following 12 months and the difference appeared to continue. VINKU 5V-study is currently investigating the clinical history, prevalence of asthma and airway hyperreactivity of these same children at school-age. The mechanism of rhinovirus associated risk or why they respond to prednisolone are largely unknown. However, the susceptibility to rhinovirus infections is associated with atopy and therefore it is possible these children may have impaired anti-inflammatory (Treg) responses and more likely to wheeze with any pro-inflammatory response (Th1 or Th2). Moreover, they may not effectively clear viruses, because they can not limit rhinovirus to nose and it spreads to lower airways and causes wheezing. VINKU 2-study will prospectively investigate the immunological events in young first-time wheezers affected by rhinovirus, and prospectively study the clinical efficacy of systemic corticosteroid in them. Most likely these children will benefit from the drug in terms of less recurrent wheezing, the investigators will also explore immunological effects of the drug and their link to clinical efficacy. The results are expected to give basis for the prevention of asthma and for the development of new treatment strategies and they can be directly applied to clinical medicine.", - "NCTID": "NCT00731575" - }, - { - "brief_title": "Airway Inflammation and Bronchial Hyperresponsiveness in Rhinitic Children With or Without Asthma", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Rhinitis', 'Asthma', 'Inflammation', 'Hypersensitivity']", - "diseases_list": [ - "Rhinitis", - "Asthma", - "Inflammation", - "Hypersensitivity" - ], - "enrollment": "280.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of allergic rhinitis and/or asthma \n\n Sensitized to more than 1 common aeroallergens \n\n ", - "exclusion_criteria": ": \n\n Respiratory infection 2 weeks prior to initial visit \n\n Children with nasal polyposis \n\n History of immunotherapy \n\n Unable to complete the test or had limited understanding \n\n Use of systemic corticosteroids 4 weeks prior to initial visit \n\n Nasal and inhaled corticosteroids 2 weeks prior to initial visit \n\n Leukotriene receptor antagonists 2 weeks prior to initial visit", - "brief_summary": "This is a prospective observational study , to clarity the characteristics of airway inflammation, airway reactivity and airway resistance in rhinitic children with or without asthma and to explore the possible predictors in the progression of allergic rhinitis to asthma.", - "NCTID": "NCT02360072" - }, - { - "brief_title": "Chest Ultrasound of ER Patients With Cough or SOB", - "phase": "", - "drugs": "['Nuvis Diagnostic Ultrasound System']", - "drugs_list": [ - "Nuvis Diagnostic Ultrasound System" - ], - "diseases": "['Cough', 'Dyspnea', 'Wheezing']", - "diseases_list": [ - "Cough", - "Dyspnea", - "Wheezing" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Presenting to the Emergency Department with cough, wheezing and/or dyspnea (shortness of breath) \n\n Referred for CXR and/or CT scan \n\n ", - "exclusion_criteria": ": \n\n Life threatening medical condition requiring immediate treatment \n\n Unable to sit up for a chest ultrasound \n\n Unable to consent \n\n Pregnant \n\n Unable to speak, read and write in English", - "brief_summary": "Acute dyspnea (shortness of breath) is a common complaint for patients presenting to the Emergency Department (ED). The chest radiograph (CXR) has been the mainstay in evaluating patients with shortness of breath and often provides the timely diagnosis of pneumonia, pneumothorax, pulmonary edema, among other primary diseases of the lung. There are limitations with chest radiograph such as large body mass (e.g, obesity) and patient positioning. On occasion, chest radiography findings are difficult to interpret. Lung ultrasonography may offer a means of clarifying ambiguous results.~The objective of this study to determine the usefulness of point of care lung ultrasound in evaluating patients presenting to the ED with shortness of breath, cough and/or wheezing.", - "NCTID": "NCT02269761" - }, - { - "brief_title": "Assessment of Cough and Wheeze With Breath Sound Documenting Device", - "phase": "", - "drugs": "['PulmoTrack\u00ae 2010 with WIM-PC\u2122 and WIM-CC\u2122 Technologies']", - "drugs_list": [ - "PulmoTrack\u00ae 2010 with WIM-PC\u2122 and WIM-CC\u2122 Technologies" - ], - "diseases": "['Respiratory Sounds']", - "diseases_list": [ - "Respiratory Sounds" - ], - "enrollment": "55.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient and/or parents/guardian signed informed consent \n\n Patients with cough or shortness of breath \n\n ", - "exclusion_criteria": ": \n\n Chest tubes \n\n Skin lesions precluding attachment of sensors \n\n Respiratory distress \n\n Pregnant women", - "brief_summary": "The study goal is to create a database of respiratory sounds recordings, to evaluate and validate the WIM technology and to evaluate the efficacy of a specific treatment by comparing the severity of the respiratory symptoms before and after the administration of the treatment.", - "NCTID": "NCT00711399" - }, - { - "brief_title": "Anti-inflammatory H1 Antihistamines Allergic Rhinitis", - "phase": "Phase 4", - "drugs": "['Levocetirizine', 'Desloratadine']", - "drugs_list": [ - "Levocetirizine", - "Desloratadine" - ], - "diseases": "['Allergic Rhinitis']", - "diseases_list": [ - "Allergic Rhinitis" - ], - "enrollment": "115.0", - "inclusion_criteria": "inclusion criteria: \n\n persistent allergic rhinitis \n\n ", - "exclusion_criteria": ": \n\n the presence of asthma or nasal polyps, \n\n acute and chronic upper respiratory infections, \n\n administration of intranasal or systemic corticosteroids or H1 antihistamines in the past 30 days.", - "brief_summary": "The main purpose of the treatment of persistent allergic rhinitis is to improve symptoms and patients' quality of life and prevent the development of asthma. Therapeutic strategies also target a reduction of pro-inflammatory mediators released from activated cells, including mast cells and epithelial cells. The presence of allergic inflammation in nasal mucosa may increase the risk of asthma occurrence, especially in patients with persistent allergic rhinitis. H1 antihistamines are widely recommended in all types of allergic rhinitis, regardless of symptom severity or persistence. They control all of the symptoms, but to a lesser extent nasal congestion. New generation agents, such as levocetirizine and desloratadine, possess anti-inflammatory properties, reducing allergic inflammation.", - "NCTID": "NCT02507635" - }, - { - "brief_title": "Asthma Clinical Research Network (ACRN)", - "phase": "Phase 3", - "drugs": "['Albuterol', 'Colchicine', 'Adrenal Cortex Hormones', 'Adrenergic-Beta Agonists']", - "drugs_list": [ - "Albuterol", - "Colchicine", - "Adrenal Cortex Hormones", - "Adrenergic-Beta Agonists" - ], - "diseases": "['Asthma', 'Lung Diseases']", - "diseases_list": [ - "Asthma", - "Lung Diseases" - ], - "enrollment": "0.0", - "inclusion_criteria": "Patients with asthma; specific eligibility criteria vary for each study.", - "exclusion_criteria": "", - "brief_summary": "This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma.", - "NCTID": "NCT00000577" - }, - { - "brief_title": "Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR", - "phase": "", - "drugs": "['Levocetirizine dihydrochloride']", - "drugs_list": [ - "Levocetirizine dihydrochloride" - ], - "diseases": "['Rhinitis, Allergic, Seasonal']", - "diseases_list": [ - "Rhinitis", - "Allergic", - "Seasonal" - ], - "enrollment": "459.0", - "inclusion_criteria": "inclusion criteria: \n\n male or female subjects \u2265 12 years \n\n 2 year history of seasonal allergic rhinitis \n\n documented hypersensitivity to local seasonal allergens (grass pollen) \n\n documented pollen-induced asthma \n\n without acute ongoing exacerbation of asthma or allergic rhinitis \n\n no continuous ongoing treatment for rhinitis or asthma \n\n ", - "exclusion_criteria": ": \n\n non-allergic rhinitis and anatomic abnormalities disturbing the analysis of nasal capacity \n\n symptomatic rhinitis or asthma due to tree pollens \n\n currently treated by specific grass pollen immunotherapy \n\n suffering from non-allergic asthma \n\n chronic use of inhaled steroids and/or long acting \u03b22 agonists; and/or corticosteroid dependent asthma \n\n atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids \n\n contraindication for salbutamol use", - "brief_summary": "Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR", - "NCTID": "NCT00521040" - }, - { - "brief_title": "Magnesium and Asthma - Clinical Trials", - "phase": "Phase 2", - "drugs": "['Magnesium']", - "drugs_list": [ - "Magnesium" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "240.0", - "inclusion_criteria": "Mild to moderate persistent asthma (NAEPP 1997 revised guidelines) \n\n Current use of inhaled beta-2- agonists or steroid inhaler therapy only (No use of prednisone in past 3 months) \n\n No use of products (i.e. antacids, laxatives, supplements) containing more than 50 mg Mg daily in the last 3 months \n\n No current use of theophylline, leukotriene antagonists, or other systemic immunomodulating compounds \n\n Nonsmoker \n\n No concurrent pulmonary disease (pulmonary hypertension, cystic fibrosis, sarcoidosis, bronchiectasis, hypersensitivity pneumonitis, restrictive lung disease, abnormal DLCOva) \n\n No concurrent medical diagnoses (alcoholism, coronary artery disease, diabetes, HIV infection, chronic hepatitis, uncontrolled hypertension, chronic renal failure or a psychiatric disorder that is judged to make full participation difficult) \n\n Not pregnant or lactating.", - "exclusion_criteria": "", - "brief_summary": "Asthma currently affects an estimated 15 million Americans. A number of studies have found an association between low dietary magnesium (Mg) intake and increased asthma incidence and severity of symptoms. However, clinical intervention trials are necessary to directly assess whether there is a true protective or preventative causal relationship between low Mg and asthma. In our study, we will assess the effects of 6 1/2 months of oral Mg supplements or placebo on clinical markers of asthma control, indirect biomarkers of inflammation, bronchial hyperresponsiveness, and indices of oxidative defense and damage in subjects with mild to moderate persistent asthma.", - "NCTID": "NCT00029510" - }, - { - "brief_title": "Study to Assess the Efficacy of Ipratropium Bromide Associated With High Dose Salbutamol by Repeated Nebulisation Versus Repeat Nebulisation of Salbutamol Alone, in Acute Asthmatic Attacks in Young Children", - "phase": "Phase 4", - "drugs": "['Ipratropium bromide', 'Placebo', 'Salbutamol']", - "drugs_list": [ - "Ipratropium bromide", - "Placebo", - "Salbutamol" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "3.0", - "inclusion_criteria": "inclusion criteria: \n\n Boys or girls between 3 and 6 years old \n\n Presenting to emergency departments with an acute asthmatic attack \n\n Requiring nebulised bronchodilator therapy \n\n Rint increased by 200 % compared to theoretical Rint \n\n Signed, informed consent obtained from the child's parents/legal guardian in accordance with current national legislation and good clinical practice (GCP) defined by the International Conference on Harmonization (ICH) \n\n ", - "exclusion_criteria": ": \n\n Ipratropium bromide received within four hours before admission \n\n First acute asthmatic attack \n\n Hospital admission to intensive care with asthma within six months before inclusion \n\n Hospital admission for asthma during the month prior to inclusion \n\n Corticosteroid-dependent asthma (oral corticosteroid therapy) or recently stopped corticosteroid therapy \n\n Concomitant cardiac disease \n\n Life threatening disease requiring immediate management; including: silent chest on auscultation, cyanosis, bradycardia less than 60 beats/min (bpm), confusion, coma \n\n Hypersensitivity to ipratropium bromide, salbutamol, or to any of their excipients \n\n Renal or hepatic insufficiency \n\n Poorly controlled diabetes \n\n Patients suffering from a disease considered to be severe by the investigator and which, in the opinion of the investigator, could interfere or invalidate the measurements performed in the trial \n\n Past history of lung surgery \n\n Major respiratory disease: pulmonary fibrosis, bronchiectasis, sarcoidosis, tuberculosis, respiratory disease due to AIDS, cystic fibrosis \n\n Patients unable to follow with protocol or correctly undergo the evaluations \n\n Patients who are taking part in another clinical trial during this trial or who have done so within the month before the trial \n\n Previous participation in this trial", - "brief_summary": "To determine whether addition of ipratropium bromide to salbutamol nebulisations produces significantly greater bronchodilation in young children presenting to an emergency department with an acute attack of asthma", - "NCTID": "NCT02235428" - } - ] - }, - { - "patient_id": "sigir-201517", - "patient": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", - "0": [ - { - "brief_title": "Home-Based or Clinic-Based Human Papillomavirus (HPV) Screening", - "phase": "", - "drugs": "['Cervical Papanicolaou Test', 'Cytology Specimen Collection Procedure', 'Questionnaire Administration', 'Screening Method', 'Screening Method']", - "drugs_list": [ - "Cervical Papanicolaou Test", - "Cytology Specimen Collection Procedure", - "Questionnaire Administration", - "Screening Method", - "Screening Method" - ], - "diseases": "['Atypical Squamous Cell of Undetermined Significance', 'Cervical Carcinoma', 'Cervical Intraepithelial Neoplasia Grade 2/3', 'Health Status Unknown', 'Human Papillomavirus Infection', 'Low Grade Cervical Squamous Intraepithelial Neoplasia', 'Stage 0 Cervical Cancer']", - "diseases_list": [ - "Atypical Squamous Cell of Undetermined Significance", - "Cervical Carcinoma", - "Cervical Intraepithelial Neoplasia Grade 2/3", - "Health Status Unknown", - "Human Papillomavirus Infection", - "Low Grade Cervical Squamous Intraepithelial Neoplasia", - "Stage 0 Cervical Cancer" - ], - "enrollment": "1335.0", - "inclusion_criteria": "inclusion criteria: \n\n Able to provide informed consent in English \n\n ", - "exclusion_criteria": ": \n\n Have had hysterectomy \n\n Currently pregnant \n\n Received treatment of cervical dysplasia with LEEP, cone biopsy, laser procedure or cryotherapy within THREE years \n\n Received colposcopy of cervix within TWO years \n\n Received Pap test within ONE year \n\n Immunocompromised (positive human immunodeficiency virus [HIV] test, transplant recipient, received chemotherapy for cancer, or taking immunosuppressant drugs) \n\n Decisionally impaired adults requiring a legally authorized representative", - "brief_summary": "This randomized clinical trial studies home-based HPV or clinic-based Pap screening for cervical cancer. It is not yet known whether home-based screening is more effective, cost-effective, and/or acceptable than clinic-based screening for cervical cancer.", - "NCTID": "NCT01550783" - }, - { - "brief_title": "Cervical Cancer Screening With Human Papillomavirus Testing", - "phase": "", - "drugs": "['HPV screening']", - "drugs_list": [ - "HPV screening" - ], - "diseases": "['CIN3', 'CIN2', 'Cervical Cancer']", - "diseases_list": [ - "CIN3", - "CIN2", - "Cervical Cancer" - ], - "enrollment": "50000.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged 30-64 years \n\n Mentally competent to be able to understand the consent form \n\n Able to communicate with study staff \n\n Physically able to have a pelvic exam \n\n ", - "exclusion_criteria": ": \n\n Reporting no previous sexual activity \n\n History of cervical cancer \n\n Previous treatment for cervical pre-cancer in the last six months \n\n Hysterectomy \n\n Plans to move out of the study area in the next 12 months \n\n Screened for cervical cancer in the last 12 months (depending on local regulations)", - "brief_summary": "HPV testing for primary cervical cancer screening of women over 30 years of age is likely to become the standard of care in the near future in many areas of the world. Its high sensitivity can significantly improve the effectiveness of screening programs and its prolonged negative predictive value can allow extension of screening intervals. However, a single HPV test has low positive predictive value and can lead to unnecessary workup and over-treatment and generate unnecessary distress. This multi-centric study will screen 50,000 women with HPV testing and compare several triage approaches that can follow HPV testing in order to make an HPV-based screening programme efficient, affordable and sustainable.", - "NCTID": "NCT01881659" - }, - { - "brief_title": "Follow-up Study of GSK Biologicals' Human Papilloma Virus (HPV) Vaccine to Prevent Cervical Infection in Young Adults", - "phase": "Phase 2", - "drugs": "['HPV 16/18 VLP AS04']", - "drugs_list": [ - "HPV 16/18 VLP AS04" - ], - "diseases": "['Infections, Papillomavirus']", - "diseases_list": [ - "Infections", - "Papillomavirus" - ], - "enrollment": "776.0", - "inclusion_criteria": "inclusion criteria: \n\n Participated in study 580299/001 and received all three doses of vaccine/placebo. \n\n Written informed consent obtained from the subject prior to enrollment \n\n ", - "exclusion_criteria": ": \n\n Decoding of the subject's treatment allocation to either the subject or the investigator in study 580299/001.", - "brief_summary": "Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This is an observer blind follow up study of the study HPV-001, which evaluated the ability of the HPV vaccine to prevent HPV infection. The current study invites all of the 1113 subjects in the HPV-001 study that received all three doses of vaccine/placebo to be enrolled and followed-up for several additional years to see if the HPV vaccine prevents HPV-16 and HPV-18 infections and to evaluate the safety of the vaccine. Subjects will remain in the same study group as in the primary study. No vaccine or placebo will be administered in this study.~The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.", - "NCTID": "NCT00120848" - }, - { - "brief_title": "Transmission Reduction and Prevention With HPV Vaccination (TRAP-HPV) Study", - "phase": "Phase 4", - "drugs": "['HPV vaccine, Gardasil 9', 'Hepatitis A vaccine']", - "drugs_list": [ - "HPV vaccine", - "Gardasil 9", - "Hepatitis A vaccine" - ], - "diseases": "['Human Papillomavirus Infection']", - "diseases_list": [ - "Human Papillomavirus Infection" - ], - "enrollment": "1000.0", - "inclusion_criteria": "inclusion criteria: \n\n Couple must have been in a new relationship that started no more than six months prior to study entry \n\n Both partners plan on remaining in Montreal for at least 1 year \n\n Plan on having continued sexual contact with partner \n\n Be willing to comply with study procedures \n\n ", - "exclusion_criteria": ": \n\n Volunteers must not have been vaccinated against HPV-Gardasil-9 (both partners) \n\n Any history of cervical, penile, oral or anal cancers \n\n Being pregnant or plan on immediately becoming pregnant", - "brief_summary": "Human papillomavirus (HPV) is a member of the Papillomaviridae family of DNA viruses that is capable of infecting humans. HPV infection can cause cancers of the cervix, vulva, vagina, and anus in women or cancers of the anus and penis in men. Two prophylactic vaccines have been proven to be highly effective in preventing the acquisition of HPV infection and the genital precancerous lesions caused by it. However, we do not know yet if a previously infected individual, once vaccinated, would be less infective to her or his sexual partner. We plan to conduct a study, called Transmission Reduction And Prevention with HPV vaccination (TRAP-HPV) study to answer this question. It will include 500 sexually active couples* (total of 1000 individuals) in university student health clinics in Montreal (age 18-45 years). It will be a randomized placebo-controlled, double-blinded intervention trial. Study participants will be followed up to 12 months. Behavioural and biological data will be collected at the time of study enrolment, then at months 2, 4, 6, 9 and 12 post-enrolment. The results of this trial will be invaluable in informing policies regarding vaccination of women and men.", - "NCTID": "NCT01824537" - }, - { - "brief_title": "Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18", - "phase": "Phase 3", - "drugs": "['Cervarix\u2122', 'Havrix\u2122-based investigational formulation']", - "drugs_list": [ - "Cervarix\u2122", - "Havrix\u2122-based investigational formulation" - ], - "diseases": "['Infections, Papillomavirus']", - "diseases_list": [ - "Infections", - "Papillomavirus" - ], - "enrollment": "18729.0", - "inclusion_criteria": "inclusion criteria: \n\n A woman whom the investigator believes that she and/or her parents/legally acceptable representative can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits). \n\n A woman between, and including, 15 and 25 years of age at the time of the first vaccination. \n\n Written informed consent must be obtained from the subject prior to enrollment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legal guardian of the subject and, in addition, the subject should sign and personally date a written informed assent). \n\n Subject must be free of obvious health problems as established by medical history and clinical examination before entering into the study. \n\n Subject must have a negative urine pregnancy test. \n\n Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using adequate contraceptive precautions for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series. \n\n Has had no more than 6 lifetime sexual partners prior to enrollment. This criterion may not be applicable in subjects less than 18 years of age, according to local regulatory/ethical requirements. \n\n Subject must have intact cervix. \n\n ", - "exclusion_criteria": ": \n\n Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study. \n\n A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Months 0-8). \n\n Previous administration of components of the investigational vaccine. \n\n Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. \n\n Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. \n\n Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. days 0-29) each dose of vaccine. Administration of some routine vaccines up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window. \n\n Previous vaccination against human papillomavirus (HPV). \n\n History of vaccination against Hepatitis A or a known clinical history of Hepatitis A disease. \n\n History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test. \n\n Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination. \n\n History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines. \n\n Hypersensitivity to latex. \n\n Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests. \n\n History of chronic condition(s) requiring treatment. \n\n Received immunoglobulins and/or blood product within 90 days preceding enrollment. Enrollment will be deferred until the subject is outside of specified window. \n\n Acute disease at the time of enrolment. \n\n Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a pelvic exam cannot be performed. Enrollment will be deferred until condition is resolved according to investigator's medical judgement.", - "brief_summary": "Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in young adolescents and women of 15/25 years of age at study start. Approximately 18.000 study subjects will either receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.~The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.", - "NCTID": "NCT00122681" - }, - { - "brief_title": "Acceptability of Human Papillomavirus (HPV) Vaccine in Female Sex Workers", - "phase": "Phase 4", - "drugs": "['Gardasil']", - "drugs_list": [ - "Gardasil" - ], - "diseases": "['Human Papillomavirus Infection']", - "diseases_list": [ - "Human Papillomavirus Infection" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Between the age of 18 and 26 years \n\n Registered female sex worker living in Lima \n\n Healthy with no known immune deficiency \n\n Willing to participate in a study of HPV vaccine including a Pap smear, three pregnancy tests, blood draws, and three vaccine administrations over 7 months \n\n Willing to provide informed consent \n\n ", - "exclusion_criteria": ": \n\n Currently pregnant or planning to get pregnant in the next six months \n\n Known immune deficiency disorder \n\n Current receipt of immunosuppressive drugs \n\n Allergy to yeast or known contraindication to HPV vaccine \n\n Women who have had their cervix removed \n\n Previous HPV vaccination \n\n Current fever over 100 degrees Fahrenheit", - "brief_summary": "The primary objectives of this study are to determine the acceptance and potential for the effective use of HPV vaccine in the standard and a modified schedule in female sex workers. Secondary objectives include ascertaining the prevalence of HPV types among female sex workers by age and sexual experience.", - "NCTID": "NCT00925288" - }, - { - "brief_title": "Clinical Evaluation of the APTIMA\u00ae HPV Assay and Comparison With the HR HC2\u00ae Test Using LBC ThinPrep\u00ae Specimens", - "phase": "", - "drugs": "['Thinprep\u00ae LBC', 'APTIMA\u00ae HPV Assay', 'HR HC2\u00ae HPV DNA', 'Colposcopy']", - "drugs_list": [ - "Thinprep\u00ae LBC", - "APTIMA\u00ae HPV Assay", - "HR HC2\u00ae HPV DNA", - "Colposcopy" - ], - "diseases": "['Human Papilloma Virus Infection']", - "diseases_list": [ - "Human Papilloma Virus Infection" - ], - "enrollment": "10000.0", - "inclusion_criteria": "inclusion criteria: \n\n Women aged 30 - 60 years \n\n Women attending gynaecological practices for routine screening \n\n Women who gave informed consent to participation in the study \n\n ", - "exclusion_criteria": ": \n\n Women with hysterectomy or known destructive therapy to the cervix \n\n Women who are pregnant \n\n Women with an abnormal cytology result during the previous 6 months \n\n Women with known HIV infection or history of transplants \n\n Women vaccinated against HPV \n\n Women participating in another research protocol", - "brief_summary": "To assess and compare the performance of the HR HPV HC2\u00ae test (Qiagen/Digene) and the APTIMA\u00ae HPV Assay (Hologic) using LBC Specimens (ThinPrep\u00ae Pap Test) for the detection of HPV infection and high-grade CIN lesions in a screening population of women 30 years of age or older in Germany.", - "NCTID": "NCT02634190" - }, - { - "brief_title": "Oral Human Papillomavirus Infection in HIV-infected Men", - "phase": "", - "drugs": "['Oral swabs for HPV-typing and high-risk HPV-determination']", - "drugs_list": [ - "Oral swabs for HPV-typing and high-risk HPV-determination" - ], - "diseases": "['Papillomavirus Infections', 'HIV Infections']", - "diseases_list": [ - "Papillomavirus Infections", - "HIV Infections" - ], - "enrollment": "500.0", - "inclusion_criteria": "inclusion criteria: \n\n HIV-infected men who have sex with men \n\n ", - "exclusion_criteria": ": \n\n None", - "brief_summary": "Human papillomavirus (HPV)-infection belong to the most common sexually transmitted diseases worldwide. HIV-infected men having sex with men /MSM) are strongly associated with a higher prevalence of genitoanal HPV-infection, and perianal HPV-infections have been detected in up to 90% of HIV-positive men. The data concerning the incidence of oral HPV-infection in HIV-positive men, especially in the era of highly antiretroviral therapy, are conflicting. Thus, this prospective study mainly focuses on the incidence and prevalence of oral HPV-infection, spectrum of HPV-types, and oral high-risk HPV viral load in HIV-positive men.", - "NCTID": "NCT00421486" - }, - { - "brief_title": "Randomized Clinical Trial on Clinical Management of ASCUS and LSIL (ALTS)", - "phase": "Phase 3", - "drugs": "['Thinprep', 'Hybrid capture 2', 'Colposcopy']", - "drugs_list": [ - "Thinprep", - "Hybrid capture 2", - "Colposcopy" - ], - "diseases": "['Cervical Intraepithelial Neoplasia']", - "diseases_list": [ - "Cervical Intraepithelial Neoplasia" - ], - "enrollment": "5060.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesion (LSIL) \n\n 18 years or older \n\n Able to give informed consent with reasonable likelihood of follow-up \n\n ", - "exclusion_criteria": ": \n\n Previous Hysterectomy \n\n History of excisional or ablative treatment of cervix, such as laser treatment, radiation therapy, cauterization (burning), freezing or surgery such as cone biopsy or loop electrosurgical excision procedure (LEEP). \n\n Already known to be pregnant \n\n Already known to be human immunodeficiency virus (HIV) positive (HIV may negatively affect the clinical history of human papillomavirus (HPV), making triage less appropriate.", - "brief_summary": "Approximately 65 million Pap smears are performed each year in the United States. The vast majority of results are negative (no abnormality identified) but about 5 percent to 8 percent are reported as abnormal. Most low-grade changes regress spontaneously; only a minority of such lesions would progress to a cancer precursor without treatment. However, there is no way to determine morphologically which patients are at risk or progression. Therefore, both high- and low-grade lesions were often managed with colposcopy and directed biopsy.~Epidemiologic, virologic and molecular studies have clearly demonstrated that human papillomavirus (HPV) is the central cause of cervical cancer. The motivation for the Atypical squamous cells of undetermined significance (ASCUS)- Low grade squamous intraepithelial lesion (LSIL) Triage Study (ALTS) trial was to use the information we have gained about the role of HPV to design better treatment and prevention strategies to reduce the burden of cervical cancer and its precursors.~ALTS consisted of three management strategies: (1) immediate colposcopy of all women; (2) repeat cytology with colposcopy only if the results show a high grade lesion; and (3) HPV testing and repeat cytology in combination, with referral to colposcopy if either the HPV test is positive or the cytology shows a high grade lesion. Four Clinical Centers University of Alabama, Birmingham Alabama (AL); Magee-Womens Hospital, Pittsburgh Pennsylvania (PA); University of Oklahoma, Oklahoma City OK; and University of Washington, Seattle Washington (WA) enrolled approximately 5,000 women with recent diagnosis of ASCUS or LSIL. Participants were followed at six month intervals for a total of 2 years.~The ALTS database and ALTS specimens continue to be a valuable research resource in studies of cervical cancer precursors, screening tests, visual assessment of the cervix and investigation of biomarkers.", - "NCTID": "NCT01131312" - }, - { - "brief_title": "The IMAP Study Improving Management of Mildly Abnormal Pap Smears", - "phase": "Phase 3", - "drugs": "['HPV DNA testing', 'Conventional management (repeat Pap smear at 6 months)', 'Decision aid with choice of management']", - "drugs_list": [ - "HPV DNA testing", - "Conventional management (repeat Pap smear at 6 months)", - "Decision aid with choice of management" - ], - "diseases": "['Cervix Neoplasms']", - "diseases_list": [ - "Cervix Neoplasms" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Women with ONLY the following results on a routine Pap smear: \n\n Low grade epithelial abnormality; \n\n Minor changes in squamous cell; \n\n Minor changes in squamous cells with appearances consistent with Papillomavirus \n\n Women aged between 18-70 years \n\n ", - "exclusion_criteria": ": \n\n Women who are pregnant or planning to become pregnant in the next 12 months \n\n Women with previous Pap smear abnormality for 2 years.", - "brief_summary": "The study compares the psychosocial outcomes of different management strategies for women with minor atypia (including 'HPV effect') detected on Pap smears: conventional management (a repeat Pap smear at 6 months) versus Human papillomavirus (HPV) DNA testing, a new method proposed for the management of minor atypia and the informed choice of either management supported by a decision aid.~The study examines women's informed preferences for each of these options and compares the psychosocial outcomes in women who are or are not given the choice of management.~HPV DNA testing offers considerable changes to the management of women with minor atypia and there is evidence from the USA which suggests that the use of HPV DNA testing as a triage strategy is effective for women within this group (Solomon et al 2001). The introduction of HPV DNA testing may bring both benefits and harms to women. These harms and benefits are not well understood. Examination of the psychosocial outcomes of HPV DNA testing compared to conventional management and women's preferences for each is needed to guide decisions concerning HPV DNA testing in cervical screening in Australia and also internationally.", - "NCTID": "NCT00119509" - }, - { - "brief_title": "Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease", - "phase": "Phase 4", - "drugs": "['Human Papillomavirus Vaccine']", - "drugs_list": [ - "Human Papillomavirus Vaccine" - ], - "diseases": "['Inflammatory Bowel Disease', 'Uterine Cervical Dysplasia']", - "diseases_list": [ - "Inflammatory Bowel Disease", - "Uterine Cervical Dysplasia" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria: \n\n Women 9-26 years of age \n\n Have inflammatory bowel disease (ie. Crohns disease or ulcerative colitis) \n\n ", - "exclusion_criteria": ": \n\n Pregnancy \n\n Taking corticosteroids \n\n Allergy to yeast aluminum component of the HPV vaccine \n\n Positive for all HPV types in the Gardasil vaccine-6, 11, 16, 18", - "brief_summary": "The Gardasil vaccine, a vaccine targeted towards the human papillomavirus (HPV), has been shown to prevent the transmission of several strains of HPV in young women. Women with inflammatory bowel disease (IBD) may not respond as well to this vaccine, either due to having IBD or due to immunosuppressants used to control IBD. This study will test how well women with IBD respond to the Gardasil vaccine.", - "NCTID": "NCT01034358" - }, - { - "brief_title": "Overlooked Population at Risk for AIN.", - "phase": "", - "drugs": "['Screening Anal Pap Smear - No High Resolution Anoscopy', 'Screening Anal Pap Smear - With High Resolution Anoscopy']", - "drugs_list": [ - "Screening Anal Pap Smear - No High Resolution Anoscopy", - "Screening Anal Pap Smear - With High Resolution Anoscopy" - ], - "diseases": "['High Grade Cervical Dysplasia', 'Cervical Cancer']", - "diseases_list": [ - "High Grade Cervical Dysplasia", - "Cervical Cancer" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Women \u2265 40 years old \n\n Previous or current high grade cervical dysplasia or cervical cancer \n\n ", - "exclusion_criteria": ": \n\n Women \u2265 40 years old because the median time between the diagnosis of anal cancer and previous cervical cancer is approximately 20 years. \n\n chemotherapy or radiation therapy within the last 6 months", - "brief_summary": "The purpose of this study is to determine the possibility and compliance of performing anal Pap smear and Human Papilloma Virus (HPV) DNA testing on women with high grade lower genital tract dysplasia or cervical cancer and determining the prevalence of anal dysplasia in this population using a high-resolution anoscopy (HRA). In addition, it is being done to potentially develop screening, diagnostic and treatment protocol for anal dysplasia in women with high-grade lower genital tract dysplasia or cervical cancer.", - "NCTID": "NCT01953094" - }, - { - "brief_title": "The Effect of Probiotics on the Clearance of the Human Papillomavirus and on Cytological Lesions Caused by the Virus", - "phase": "", - "drugs": "['probiotic drinkers']", - "drugs_list": [ - "probiotic drinkers" - ], - "diseases": "['HPV-related Cytological Abnormalities on PAP Smear (LSIL)']", - "diseases_list": [ - "HPV-related Cytological Abnormalities on PAP Smear (LSIL)" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n women with a new LSIL diagnosis an HPV positivity on PAP smear \n\n ", - "exclusion_criteria": ": \n\n women over 65 \n\n immunocompromised patients (because of disease or drugs)", - "brief_summary": "Aim: In this project proposition the investigators would like to examine the effect of immune modulation by probiotics on the clearance of HPV-infections.~This study provides a model for viral infection but also for cancer precursors. This would be an excellent model (and the only possible short-term model) to examine an effect on cancer precursors. Cancer precursors (cytological abnormalities such as L-SIL) are a scientifically accepted surrogate endpoint for cervical cancer, for example in HPV-vaccine studies.~Research question: Does daily intake of probiotics lead to a better immune-response in HPV-infected women, i.e. does it facilitate clearance of the virus and/or regression of cytological lesions?", - "NCTID": "NCT01097356" - }, - { - "brief_title": "Long Term Immunogenicity of Quadrivalent Human Papillomavirus Vaccine (Gardasil\u00ae)in HIV-infected Adolescents and Young Adults", - "phase": "Phase 3", - "drugs": "['Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil \u00ae)', 'Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil \u00ae)']", - "drugs_list": [ - "Quadrivalent Human Papillomavirus (6", - "11", - "16 and 18) vaccine (Gardasil \u00ae)", - "Quadrivalent Human Papillomavirus (6", - "11", - "16 and 18) vaccine (Gardasil \u00ae)" - ], - "diseases": "['HPV', 'HIV']", - "diseases_list": [ - "HPV", - "HIV" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n For both HIV-infected and healthy subjects: \n\n Subjects aged 13-27 years, females and males \n\n Written informed consent from parent or guardian if applicable (age<18 years) \n\n For HIV-infected subjects: \n\n HIV-positive \n\n Asymptomatic subjects (generalized lymphadenopathy is accepted) \n\n Lymphocyte CD4+ count > or equal to 350 cells/mm3 \n\n For subjects receiving HAART: \n\n Good compliance to therapy \n\n At least two suppressed viral loads HIV-RNA (<37copies/ml9 during 6 months prior to enrollment. \n\n ", - "exclusion_criteria": ": \n\n For female subjects (both HIV-infected and healthy) \n\n Pregnancy or breastfeeding \n\n Total hysterectomy. Participants who have undergone partial hysterectomy and have a cervix are not excluded. \n\n For both females and males (HIV-infected and healthy): \n\n Prior vaccination with quadrivalent HPV vaccine Gardasil before study entry. \n\n History of severe allergic reaction after previous vaccination or hypersensitivity to any vaccine component. \n\n Any serious chronic or progressive disease (other than HIV) according to the judgment of the investigator: \n\n Acute infection requiring therapy or fever at time of enrollment \n\n Chronic autoimmune or oncologic disease receiving chemotherapy \n\n Concomitant therapies (other than HAART): \n\n Chronic therapy (for more than 14 days consecutively) with immunosuppressive or immunomodulating agents or chemotherapy during the 6 months prior to study entry. \n\n Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation prior to study entry. \n\n Use of investigational agents within 4 weeks prior to study enrollment. \n\n Current drug or alcohol use or dependence. \n\n Documented history of non-adherence to antiretroviral treatment regimen within 12 months prior to study entry.", - "brief_summary": "Infection with human immunodeficiency virus (HIV) is an important risk factor for HPV infection and the development of HPV-associated lesions in female and male anogenital tract. Data on safety and immunogenicity of quadrivalent human papillomavirus vaccine in HIV-infected population are few. The present study is a non-randomized controlled clinical trial with the primary objective to determine safety ad immunogenicity of quadrivalent human papillomavirus vaccine (Gardasil\u00ae) in HIV-infected female and male adolescents and young adults.", - "NCTID": "NCT01512784" - }, - { - "brief_title": "Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities", - "phase": "", - "drugs": "['human papillomavirus vaccine L1, type 6,11,16,18']", - "drugs_list": [ - "human papillomavirus vaccine L1", - "type 6,11,16,18" - ], - "diseases": "['Papillomavirus Infections']", - "diseases_list": [ - "Papillomavirus Infections" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Women between 18 and 26 years of age \n\n Women able to consent for themselves \n\n Referring Pap smear was ASCUS, + HPV or LGSIL \n\n Women who decide they wish to get the Gardasil vaccination series \n\n ", - "exclusion_criteria": ": \n\n Women who have had previous cryotherapy of the cervix, LEEP or cervical conization \n\n Women who had their first Gardasil injection prior to their referring Pap smear \n\n Women under the age of 18 \n\n Women unable to consent for themselves \n\n Women who are pregnant currently trying to conceive \n\n Women in an immunocompromised state (diabetes, HIV, on chronic immunosuppressants or steroids, etc) \n\n Women who do not want the Gardasil vaccination series", - "brief_summary": "This project will compare the rate of regression of minimally abnormal Pap smears to normal in women who receive Gardasil to a historical control group.~Research hypothesis: Women with low grade cervical dysplasia on Papanicolaou (Pap) smear that receive Gardasil vaccination will revert to a normal within one year at a rate 33% higher than historical controls that did not receive Gardasil vaccination.", - "NCTID": "NCT00501189" - }, - { - "brief_title": "Crossover Vaccination of Women Previously Randomized Into Protocol 04-C-N191", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cervical Neoplasia', 'HPV Infections']", - "diseases_list": [ - "Cervical Neoplasia", - "HPV Infections" - ], - "enrollment": "5444.0", - "inclusion_criteria": "inclusion criteria: \n\n To be eligible to receive crossover vaccination, participants must fulfill all of the following inclusion criteria: \n\n Participation Status: Women previously randomized into the HPV-16/18 vaccine trial 04-C-N191, also known as the Costa Rica Vaccine Trial. \n\n Planned Residence: Residents of Guanacaste or Puntarenas Province or willingness to visit one of the study clinics for participation. \n\n Consent: Written informed consent obtained prior to enrollment into the crossover protocol. \n\n ", - "exclusion_criteria": ": \n\n The following criteria will be checked for all potential participants at the time of enrollment. If any apply, the participant will not be included in the study. \n\n History of (a) allergic reaction (e.g., difficulty breathing) after receipt of any vaccine, (b) hypersensitivity to latex. \n\n History of vaccine related adverse events during the vaccination phase that, at the discretion of the investigators, preclude vaccination during the crossover phase. \n\n Are receiving vaccination with Cervarix , are sexually experienced and of childbearing potential (i.e., not surgically sterilized), and are unwilling to use an effective method of birth control for 30 days before vaccination until 60 days after the last Cervarix vaccination (approximately 9 months). Acceptable forms of birth control include abstinence, surgical sterilization, hormonal contraceptives (e.g., oral, injectable, implant, and patch), intrauterine devices, and diaphragm or condom. \n\n History of chronic condition that per attending doctor opinion precludes her from receiving vaccination (e.g., no proper treatment available or participant is unwilling to stay under proper treatment). \n\n The participant has a diagnosed autoimmune illness (per the specific requirement of the INCIENSA IRB). \n\n The vaccine or vaccines the participant is interested in receiving are contraindicated in her case.", - "brief_summary": "Background:~- National Cancer Institute Protocol 04-C-N191, also known as the Costa Rica Vaccine Trial, was a double-blind controlled study of the effectiveness of an experimental human papillomavirus (HPV) vaccine in preventing cervical cancer in young women in Costa Rica. Costa Rica was part of the first large study to show the association between HPV and cervical cancer, and the study contributed greatly to the understanding of this association. The women who have participated in the vaccine trial in Costa Rica are reaching the end of the follow-up period offered in the vaccine trial protocol, and as a result they are being offered the chance to have complementary vaccinations against HPV, hepatitis A, and hepatitis B.~Objectives:~To offer participants in the Costa Rica Vaccine Trial the vaccine that they did not receive during the masked portion of the trial (HPV vaccine or hepatitis A vaccine) and hepatitis B vaccination.~To collect information about exposure to known and suspected risk factors for HPV infection and cervical cancer from women who are receiving vaccination against HPV at crossover.~Eligibility:~- Women who participated in National Cancer Institute Protocol 04-C-N191.~Design:~All participants will be offered vaccination against hepatitis B.~Women who received the hepatitis A vaccine during the trial will be offered vaccination against HPV.~Women who received the HPV vaccine during the trial will be offered vaccination against hepatitis A.~Appropriate vaccinations (including a combined hepatitis A and hepatitis B vaccine) will be available to reduce the number of injections that participants will be asked to receive.~All vaccines will be given according to the manufacturer's specifications for appropriate length of time between vaccine doses.", - "NCTID": "NCT01086709" - }, - { - "brief_title": "Patient Compliance to Self-collection for Detection of HPV-DNA", - "phase": "", - "drugs": "['Self-collection', 'Gynecologist collection']", - "drugs_list": [ - "Self-collection", - "Gynecologist collection" - ], - "diseases": "['Compliance', 'Cervical Cancer']", - "diseases_list": [ - "Compliance", - "Cervical Cancer" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Women between 25-59 years-old \n\n Not pregnant \n\n Had held their last Pap smear for over a year \n\n Could read. \n\n ", - "exclusion_criteria": ": \n\n Women with previous hysterectomy \n\n History of cervical cancer or its precursors \n\n Bearers of some state of chronic immunosuppression (such as HIV ou autoimmune diseases) \n\n Those who underwent self-collection of their specimen during menstrual period", - "brief_summary": "A study to investigate the compliance of unassisted women to self-collection of specimens for Hybrid Capture (HC) for detection of Human Papilloma Virus (HPV) DNA compared to Pap smear collection by medical personnel, as screening method to identify precursor lesions of cervical cancer.", - "NCTID": "NCT02431520" - }, - { - "brief_title": "Human Papillomavirus (HPV) Vaccine (Cervarix TM) Efficacy, Immunogenicity & Safety Trial in Adult Japanese Women With GSK Biologicals HPV-16/18 Vaccine", - "phase": "Phase 2", - "drugs": "['HPV-16/18 vaccine (Cervarix\u2122)', 'Aimmugen\u2122']", - "drugs_list": [ - "HPV-16/18 vaccine (Cervarix\u2122)", - "Aimmugen\u2122" - ], - "diseases": "['Infections, Papillomavirus']", - "diseases_list": [ - "Infections", - "Papillomavirus" - ], - "enrollment": "1046.0", - "inclusion_criteria": "inclusion criteria : \n\n Subjects who the investigator/co-investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. \n\n A Japanese female subject between, and including, 20 and 25 years of age at the time of the first vaccination. \n\n Written informed consent obtained from the subject prior to enrolment. \n\n Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study. \n\n Subjects must have a negative urine pregnancy test. \n\n Subjects must be of non-childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. \n\n Subject must have an intact cervix \n\n ", - "exclusion_criteria": ": \n\n Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine/control within 30 days preceding the first dose of study vaccine/control, or planned use during the study period. \n\n Pregnant or breastfeeding women. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study. \n\n A women planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period, up to 2 months after the last vaccine dose \n\n previous administration of components of the investigational vaccine \n\n Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. \n\n Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of vaccine. Routine vaccines may be allowed up to 8 days before the first dose of study vaccine. \n\n Previous vaccination against HPV. \n\n History of vaccination against hepatitis A or a known clinical history of hepatitis A disease \n\n Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. \n\n Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination \n\n History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines \n\n Hypersensitivity to latex \n\n Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests. \n\n Cancer or autoimmune disease under treatment. \n\n History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test. \n\n Heavy bleeding or heavy vaginal discharge such that a pelvic examination can not be performed \n\n Acute disease at the time of enrolment. \n\n Oral temperature >= 37.5\u00b0C / axillary temperature > 37.5\u00b0C. \n\n Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).", - "brief_summary": "Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. This study will evaluate the efficacy in prevention of persistent HPV-16 or HPV-18 cervical infection lasting at least 6 months, the immunogenicity and safety of GSK Biologicals HPV-16/18 vaccine (Cervarix TM ) over 24 months in Japanese adult women aged 20 - 25 years of age at study start. Approximately 1000 study subjects will either receive the HPV vaccine or a control vaccine (Hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.~The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.", - "NCTID": "NCT00316693" - }, - { - "brief_title": "Evaluation of an Mhealth Intervention to Increase Adherence to Triage of HPV+ Women", - "phase": "", - "drugs": "['mHealth Intervention Group']", - "drugs_list": [ - "mHealth Intervention Group" - ], - "diseases": "['Patient Adherence']", - "diseases_list": [ - "Patient Adherence" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Women 30 years and older living in a household visited by Community Health Workers (CHWs). \n\n ", - "exclusion_criteria": ": \n\n Women with a previous HPV test. \n\n Women with precancerous lesion or cervical cancer. \n\n Current pregnancy. \n\n Women with Mental disability.", - "brief_summary": "Cervical cancer remains a serious health problem, particularly in developing countries. It is the leading cause of cancer death among women and mainly affects women of low socioeconomic status.~Evidence has shown that HPV-test self-collection can reduce social and health services barriers to screening and increase coverage. However, high coverage will not result in a decrease of disease burden if women are not diagnosed/treated. The HPV-test indicates whether a woman is positive or not, and a triage test is needed to identify HPV-positive women who need to perform diagnostic procedures. Several triage methods are available. In Argentina, cytology is used as triage method; therefore, all HPV-positive women who have performed self-collection at home need to attend health centers to undergo cytology. However, the proportion of women who have completed triage is low, therefore new innovative strategies are needed to increase attendance to cytology of these women.~This study will be carried out in Jujuy, one of the Argentinian provinces with highest cervical cancer mortality rates and where HPV- self-collection has been introduced as programmatic strategy for screening under-users.~This trial is population-based cluster-randomized study that aims to evaluate the effectiveness of a mHealth intervention versus usual care to increase adherence to cytological triage among women with HPV-positive self-collected tests.~An overall number of 240 Community Health Workers (CHWs) from the Primary Health Care System (PHCS) of the Province of Jujuy will be randomized into two groups:~mHealth Intervention Group: Women with HPV self-collected tests will receive a mixed intervention which includes counseling through an interactive Apps specifically devised to increase adherence to triage which will be run on a tablet, and SMS text messages to remind them to attend triage. In addition, Heads of CHWs, chiefs of gynecology services and CHWs will receive reminders via e-mails and SMS message to contact women if after 60 days from the HPV-results HPV+ they have not performed triage.~Usual Care Group: Women with HPV self-collected tests receive usual care.~A database built specifically for the study will be used; it will include data about randomization Group, agreement to participate in the study and socio-demographic data. Data on HPV-testing and triage will be uploaded importing the data from SITAM, using the Unique Identification Number (DNI).~Data Analysis~Effectiveness to enhance adherence to cytological triage: Adherence to triage will be considered for each CHW. This will be defined as the number of women with triage smears within 30, 60 and 90 days. There will be a comparison of the percentage of HPV-positive women that did the Pap test within those time intervals in the mHealth intervention group and the Usual Care group. The effect of the mHealth intervention against usual care will be estimated using a means difference test or a non-parametric test for independent samples.", - "NCTID": "NCT02561208" - }, - { - "brief_title": "Study to Evaluate the Efficacy of the Human Papillomavirus Vaccine in Healthy Adult Women of 26 Years of Age and Older", - "phase": "Phase 3", - "drugs": "['Cervarix', 'Placebo control']", - "drugs_list": [ - "Cervarix", - "Placebo control" - ], - "diseases": "['Infections, Papillomavirus', 'Papillomavirus Vaccines']", - "diseases_list": [ - "Infections", - "Papillomavirus", - "Papillomavirus Vaccines" - ], - "enrollment": "5752.0", - "inclusion_criteria": "inclusion criteria: \n\n A woman who the investigator believes that she can and will comply with the requirements of the protocol. \n\n A women of at least 26 years of age at the time of the first vaccination. \n\n Written informed consent obtained from the subject prior to enrolment. \n\n Free of obvious health problems as established by medical history and clinical examination before entering into the study. \n\n Subject must have intact cervix. \n\n Subject must have a negative urine pregnancy test. This test is not applicable to women of non-childbearing potential. \n\n Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using an effective method of birth control for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series. \n\n ", - "exclusion_criteria": ": \n\n Pregnant or breastfeeding (women must be at least three months post-pregnancy and not breastfeeding to enter the study). \n\n A women planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose (Month 0 - 8). \n\n Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 84). \n\n Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. \n\n Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. days 0 - 29) the first dose of study vaccine. Planned administration/administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window. \n\n Previous administration of components of the investigational vaccine \n\n Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period. \n\n History of HPV infection/treatment or planned treatment to evaluate an abnormal cervical cytology (Pap smear) test, e.g. colposcopy. \n\n Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination. \n\n History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine. \n\n Hypersensitivity to latex. \n\n Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests. \n\n History of chronic condition(s) requiring treatment. \n\n Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study vaccine, or planned administration during the study period. Enrolment will be deferred until the subject is outside of specified window. \n\n Acute disease at the time of enrolment. \n\n Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a pelvic exam cannot be performed (and no cervical sample can be taken). Enrolment will be deferred until condition is resolved according to investigators medical judgement.", - "brief_summary": "This is a multicentre study in which women were planned to receive either the Human Papillomavirus Vaccine (HPV) vaccine or control. Under Protocol Amendment 3, study participation will last approximately 48 months and involves a total of eleven scheduled visits. Under Protocol Amendment 4, study participation will last up to 84 months and involves a maximum of seventeen scheduled visits.", - "NCTID": "NCT00294047" - }, - { - "brief_title": "Type Distribution of Human Papillomavirus in Adult African Women Diagnosed With Invasive Cervical Cancer", - "phase": "", - "drugs": "['Collection of cervical cancer tissue samples', 'Data collection']", - "drugs_list": [ - "Collection of cervical cancer tissue samples", - "Data collection" - ], - "diseases": "['Infections, Papillomavirus', 'Cervical Cancer']", - "diseases_list": [ - "Infections", - "Papillomavirus", - "Cervical Cancer" - ], - "enrollment": "591.0", - "inclusion_criteria": "inclusion criteria: \n\n A female aged 21 years or more, presenting with a lesion macroscopically suggestive of invasive cervical cancer. \n\n Scheduled for cervical biopsy as per routine procedure at the participating institution on the day of the visit or on a later date. \n\n Written or oral-witnessed informed consent obtained from the subject prior to any study procedure. \n\n No prior chemo- or radiotherapy for cervical cancer. \n\n ", - "exclusion_criteria": ": \n\n Not applicable", - "brief_summary": "The aim of the study is to assess the distribution of the most frequent types of human papillomavirus in African women diagnosed with invasive cervical cancer.", - "NCTID": "NCT01207999" - }, - { - "brief_title": "Typing of Human Papilloma Virus (HPV) From Female Genital Warts", - "phase": "", - "drugs": "['Medical / Surgical Treatment']", - "drugs_list": [ - "Medical / Surgical Treatment" - ], - "diseases": "['Genital Warts', 'Human Papilloma Virus']", - "diseases_list": [ - "Genital Warts", - "Human Papilloma Virus" - ], - "enrollment": "156.0", - "inclusion_criteria": "inclusion criteria: \n\n All female patients with genital warts \n\n ", - "exclusion_criteria": ": \n\n Patients who are pregnant, too frail or ill for gynaeoclogical examination and refusal to participate", - "brief_summary": "This is a longitudinal observational study of women presenting to Groote Schuur Hospital with genital warts. The study will evaluate the socio-demographic characteristics of the women using a structured questionnaire. It will also document the site and extend of the genital warts and genotyping will be performed on the warts. HIV status will be determined with patient consent, treatment modalities will be documented as will the outcome of treatment over a 6 month's period. Risk factors for recurrence or failure of treatment will be analysed as will the costs of treating women with genital warts.", - "NCTID": "NCT01192282" - }, - { - "brief_title": "Biomarkers to Detect Anal Intraepithelial Neoplasia in Thai Men Who Have Sex With Men", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Anal Intraepithelial Neoplasia']", - "diseases_list": [ - "Anal Intraepithelial Neoplasia" - ], - "enrollment": "450.0", - "inclusion_criteria": "inclusion criteria: \n\n MSM with HIV negative \n\n MSM with HIV positive", - "exclusion_criteria": "", - "brief_summary": "The goals of this application are to assess the usefulness of biomarkers, including p16 proteins, minichromosome maintenance (MCM) proteins, high-risk human papillomavirus (HPV) types, and E6 and E7 mRNA/oncoproteins, as adjunct tools to anal Pap smear in identifying HGAIN and to study the impact of HIV infection on the characteristics of anal cytology (by anal Pap smear) and biomarkers. To fulfill these goals, in addition to routine practice, it will be necessary to follow 450 MSM (315 HIV-positives and 135 HIV-negatives) over 60 months, and perform HRA and biomarkers on all clients at baseline and every 12 months. Information from this study would inform AIN screening and follow up approaches in HIV-positive and HIV-negative MSM in both resource-limited and resource-rich settings.", - "NCTID": "NCT01637298" - }, - { - "brief_title": "Assessing the Psychosocial Burden in Women With an Abnormal Pap Results After Screening Interventions", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Papanicolaou Smear']", - "diseases_list": [ - "Papanicolaou Smear" - ], - "enrollment": "151.0", - "inclusion_criteria": "inclusion criteria: \n\n female, between 18 and 45 years of age and must have recently experienced an abnormal pap results within the past 3 months. \n\n ", - "exclusion_criteria": ": \n\n has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives \n\n has other concurrent/active STD's \n\n has a history of known prior vaccination with an HPV vaccine \n\n has a history of recent (within 1 year from date of enrollment) or ongoing alcohol abuse or other drug abuse.", - "brief_summary": "The primary purpose of this study is to assess the psychosocial burden in women who have experienced an abnormal pap results after screening interventions.", - "NCTID": "NCT00520117" - }, - { - "brief_title": "Efficacy and Safety Study of PGA (Poly-gamma Glutamic Acid) for Cervical Intraepithelial Neoplasia", - "phase": "Phase 2", - "drugs": "['Poly-gamma Glutamic Acid', 'Placebo']", - "drugs_list": [ - "Poly-gamma Glutamic Acid", - "Placebo" - ], - "diseases": "['Cervical Intraepithelial Neoplasia']", - "diseases_list": [ - "Cervical Intraepithelial Neoplasia" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Fertile women between age of 20 and 49 \n\n Patients with cervical intraepithelial neoplasia 1(CIN1) \n\n HPV(Human Papilloma Virus) positive(+) \n\n White Blood Cell Count(WBC) over 4thous/ul, Hemoglobin above over 9.0g/dL Platelet over 150thous/uL and ANC(Absolute Neutrophil Count) over 1,500 10^6/L \n\n AST(Aspartate Aminotransferase) no less than 4 times higher than normal ALT(Alanine Aminotransferase) no less than 4 times higher than normal \n\n Normal for EKG(Electrocardiography) and no active disease detected trough chest X-ray \n\n Be informed of the nature of the study and will give written informed consent \n\n ", - "exclusion_criteria": ": \n\n Malignant tumor in any organ other than cervical intraepithelial neoplasia \n\n Active liver disease, immune disorder and severe renal failure \n\n Leukemia, collagenosis, sclerosis, autoimmune disease, clinically significant allergic disease(mild allergic symptom not required medicine excluded) \n\n Diagnosed diabetes \n\n Taking any of followings affecting immunological reaction within 7 days (Glucocorticoid, vitamins, health food and oriental medicine etc) \n\n Pregnancy and breastfeeding \n\n Registered in other clinical trials \n\n Patients whom the investigator considers inappropriate to participate in the study", - "brief_summary": "The purpose of this study is to determine the efficacy and the safety of PGA(Poly-gamma Glutamic Acid) for the the fertile women with Cervical Intraepithelial Neoplasia (CIN1).", - "NCTID": "NCT01826045" - } - ], - "1": [ - { - "brief_title": "Human Papillomavirus (HPV) and Risk of Cervical Precancer and Cancer", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cervical Neoplasia']", - "diseases_list": [ - "Cervical Neoplasia" - ], - "enrollment": "131110.0", - "inclusion_criteria": "inclusion criteria: \n\n Women in KPNC aged 25 years or older who tested positive for HPV. \n\n Will also include a random sample of women who tested negative for HPV. \n\n ", - "exclusion_criteria": ": \n\n Male. \n\n Children under 18.", - "brief_summary": "Background:~In most women, HPV infection does not cause symptoms and the infection goes away on its own. In a small percentage of women, the HPV infection does not go away and sometimes can result in cervical precancer or cancer.~There are several different types of HPV. A better understanding of which types are related to cervical precancer and cancer may help guide doctors in clinical management of women who test positive for HPV and better understand why some women develop disease while others do not.~Objectives:~To determine whether certain types of HPV are more risky than others and if so, whether they warrant separate detection in screening for cervical precancer and cancer.~To determine if lasting infection by different HPV types carry different risk of cervical precancer and cancer.~To determine what viral and genetic factors influence the development of cervical precancer and cancer.~To evaluate new HPV tests and new biomarkers of cervical cancer risk.~Eligibility:~-Women 30 years of age and older who are in the cervical cancer screening program at the Kaiser Permanente health plan in Northern California. Women who tested positive for HPV and a random sample of women who tested negative for the virus are included.~Design:~-Data about participants genetic background and the type of carcinogenic HPV with which they are infected are analyzed.", - "NCTID": "NCT00435214" - }, - { - "brief_title": "Compass - Randomised Controlled Trial of Primary HPV Testing for Cervical Screening in Australia", - "phase": "", - "drugs": "['Molecular testing for HPV', 'Liquid Based Cytology']", - "drugs_list": [ - "Molecular testing for HPV", - "Liquid Based Cytology" - ], - "diseases": "['Cancer of the Cervix', 'Cervical Intraepithelial Neoplasia']", - "diseases_list": [ - "Cancer of the Cervix", - "Cervical Intraepithelial Neoplasia" - ], - "enrollment": "76181.0", - "inclusion_criteria": "inclusion criteria: \n\n Australian residents with a cervix, aged 25-69 years who are attending for routine cervical screening. (Note: since April 2016 recruitment has been confined to the younger strata, i.e. women age-eligible for HPV vaccination aged at least 25 and born on or after 1st July 1980, as the recruitment target of the older cohort was met). \n\n Participants may have been previously enrolled in the Compass Pilot but must have been discharged to routine screening. Women may also be in follow-up management for a previous abnormality or unsatisfactory cytology. \n\n ", - "exclusion_criteria": ": \n\n Previous total hysterectomy (uterus and cervix). \n\n The presence of symptoms or signs for which cervical cancer must be excluded. \n\n Currently undergoing treatment for cervical cancer. \n\n Currently enrolled in the Compass Pilot Study.", - "brief_summary": "Compass is a randomised controlled trial of primary HPV testing for cervical cancer screening in Australia. A pilot study involving 5,000 women was carried out in 2013-2014. The trial will involve recruiting 76,300 women from primary health clinics. Women aged 25-69, attending for cervical screening or for routine follow-up will be invited to participate in the 2-arm trial. A liquid-based cytology (LBC) sample will be taken from consenting women and sent to VCS Pathology. Women will be randomised in a 1:2 parallel group allocation to LBC and HPV arms using randomisation with the minimisation procedure, with stratification by birth cohort according to whether offered HPV vaccination in Australia's national publicly-funded HPV vaccination program (date of birth >=July 1st 1980 and <1st July 1980). In the LBC (active control) arm, women will undergo 2.5 yearly image read cytology screening with reflex HPV triage testing for low grade cytology. In the HPV (intervention) arm women will undergo 5 yearly HPV screening with partial genotyping enabling separate identification of HPV16 and HPV18 and referral of this group for diagnostic evaluation, and secondary randomisation of intermediate risk women testing positive for oncogenic HPV (but not HPV 16 or 18) to either image read LBC screening or dual-stained (DS) cytology testing with p16/Ki67. The laboratory reports issued to practitioners will specify the recommended management for women, according to study arm and test results.Participating women will be flagged and clinical outcomes will be tracked via the Compass Register. Data linkage between the Compass Register and HPV vaccination records held on the Australian Immunisation Register will be performed in order to integrate vaccination and screening histories for trial participants. Participants will be actively followed for an anticipated 5 years from the time of recruitment and the primary outcome is based on the total cumulative detection of CIN3+ after exit testing at 5 years. The anticipated study completion date of March 2027 takes into consideration the final migration of participants to the National Cancer Screening Register and allows for two years to follow-up any intermediate risk results occurring in the last of the recruited trial participants.", - "NCTID": "NCT02328872" - }, - { - "brief_title": "HPV Testing for Cervical Cancer Screening Study", - "phase": "", - "drugs": "['Cervical cancer screening undertaken by HPV testing as a single primary screening test with cytology triage of women who are HPV positive', 'Cervical cancer screening undertaken by HPV testing as a single primary screening test with cytology triage of women who are HPV positive']", - "drugs_list": [ - "Cervical cancer screening undertaken by HPV testing as a single primary screening test with cytology triage of women who are HPV positive", - "Cervical cancer screening undertaken by HPV testing as a single primary screening test with cytology triage of women who are HPV positive" - ], - "diseases": "['Cervical Cancer Screening']", - "diseases_list": [ - "Cervical Cancer Screening" - ], - "enrollment": "25223.0", - "inclusion_criteria": "inclusion criteria: \n\n Women from 25 to 65 years of age, registered with the Medical Services Plain in BC attending a collaborating healthcare provider for routine cervical screening in Metro Vancouver or Greater Victoria. \n\n ", - "exclusion_criteria": ": \n\n pregnant \n\n history of invasive cervical cancer \n\n no cervix \n\n HIV positive or on immunosuppressive treatments \n\n unable or unwilling to give informed consent \n\n Treatment of moderate or greater dysplasia within last 5 years", - "brief_summary": "This is a randomised controlled trial of HPV testing with cytology triage for HPV positive women compared to liquid-based cervical cytology (LBC). Although LBC is not widely used for cervical cancer screening in Canada at present, the Pan-Canadian Cervical Cancer Forum has recommended its use and as it is likely to be the standard of care by the time these data are published, the trial has been designed to account for this. Further, LBC will improve the cost-effectiveness of HPV testing because the LBC medium is suitable for both HPV testing as well as cytology and thereby allows the triage testing to be undertaken from the same sample without having to recall the women.", - "NCTID": "NCT00461760" - }, - { - "brief_title": "Human Papillomavirus (HPV) Testing to Improve Cervical Cancer Screening in the Mississippi Delta", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cervical Intraepithelial Neoplasia']", - "diseases_list": [ - "Cervical Intraepithelial Neoplasia" - ], - "enrollment": "664.0", - "inclusion_criteria": "inclusion criteria: \n\n Five-hundred women attending colposcopy and 500 women receiving cytology screening, including 250 unscreened women, will be recruited for the study. Non-pregnant, non-hysterectomized women aged 26-65 will be recruited. \n\n ", - "exclusion_criteria": ": \n\n Women under 26 or over 65 years of age. \n\n Pregnant women or women having given birth to a child in the past 8 weeks. To insure women included in the study are not pregnant, we will ask women during the consenting process if they are pregnant. Women who answer yes for either query will be excluded. Participants will also receive a reminder call for their 2-week self-collection. At that time, women again will be asked if they are pregnant. If any woman answers yes, she will be instructed to not self-collect. \n\n Women who have had a total hysterectomy. \n\n Women who have an overt cancerous lesion visible upon exam by the clinician. \n\n Other reasons to exclude women include the inability to speak English, the appearance of mental incompetence, or refusal to participate or sign the informed consent form.", - "brief_summary": "Background:~Cancer of the cervix (bottom third of the uterus, or womb) can be prevented by regular Pap tests (also called Pap smears), which check for changes in the cells of the cervix. Because many women in the United States have regular Pap smears, cervical cancer is not common in this country. However, the disease is common among women in the Mississippi Delta because of poor participation in screening programs.~The major causes of cervical cancer are persistent human papillomaviruses (HPV) infection by cancer-associated HPV types and lack of screening. These viruses cause an infection that often goes away by itself, but if it does not go away, over a long time lead to cervical cancer. HPV causes cervical abnormalities, which are detected by Pap smears and then treated.~Objectives:~-To determine whether an at-home self-collection method for obtaining cells from the cervix can be a simple, safe and inexpensive way to screen for cervical cancer for women who don t go to the health clinic regularly.~Eligibility:~Women who reside in the counties of Leflore, Sunflower, Washington or Tallahatchie, Mississippi.~Women between 26 and 65 years of age who are not pregnant and who have not had a hysterectomy.~Design:~Screening study participants undergo the following:~The doctor takes a cervical sample using the same self-collection device that women will use at home to self-collect.~Pelvic examination and Pap test. For this test, the woman lies on an exam table and the doctor inserts an instrument called a speculum into the vagina, opening it to see the cervix. A special brush is used to take a few cells from the cervix. The cells are placed on a glass slide and sent to a lab for examination.~Cervical cell specimen collection using an at-home self-collection kit that participants will use at home after 2 weeks~At-home self-collection by participant after 2 weeks.~Referral to a doctor for follow-up care, if needed.~Colposcopy (see below) in all women with a Pap test that is abnormal or positive for HPV and for some women with a normal smear.~Colposcopy study participants undergo the following:~The doctor takes a cervical sample using the same self-collection device that women will use at home to self-collect.~Colposcopy, an exam in which the doctor examines the cervix using a light and looks through a magnifying device to see if there is any abnormal tissue on the cervix. During this exam, the doctor may remove a small sample of tissue to diagnose any abnormality. Participants also have a sample collected using the self-collection kit.~At-home cervical sample collection by participant after 2 weeks.~Notification if further medical care is required and treatment if the biopsy looks abnormal.", - "NCTID": "NCT00443313" - }, - { - "brief_title": "Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)", - "phase": "Phase 3", - "drugs": "['V501', 'Comparator: Placebo', 'Human Papillomavirus (HPV) 16 Monovalent']", - "drugs_list": [ - "V501", - "Comparator: Placebo", - "Human Papillomavirus (HPV) 16 Monovalent" - ], - "diseases": "['Cervical Cancer', 'Genital Warts']", - "diseases_list": [ - "Cervical Cancer", - "Genital Warts" - ], - "enrollment": "5759.0", - "inclusion_criteria": "inclusion criteria: \n\n Female with an intact uterus with lifetime history of 0-4 sexual partners \n\n ", - "exclusion_criteria": ": \n\n Prior Human Papillomavirus (HPV) vaccination \n\n Prior abnormal paps \n\n History of genital warts", - "brief_summary": "The primary purpose of the study is to determine if GARDASIL (V501) with four components is able to prevent cervical cancer, cervical dysplasia, including Cervical Intraepithelial Neoplasia (CIN)(Any Grade) and Adenocarcinoma In Situ (AIS), and genital warts.", - "NCTID": "NCT00092521" - }, - { - "brief_title": "Recombinant Human Interferon a-2b Gel for HPV Gynecological Infections", - "phase": "Phase 2; Phase 3", - "drugs": "['Yallaferon\u00ae']", - "drugs_list": [ - "Yallaferon\u00ae" - ], - "diseases": "['HPV Infection']", - "diseases_list": [ - "HPV Infection" - ], - "enrollment": "325.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 30 to 65 years of age the sex life of female patients; \n\n , liquid-based cytology (TCT) check no intraepithelial lesions and malignant cells; \n\n , HPV DNA typing test for high-risk HPV positive (including a single high-risk type positive, and more high-risk type of positive and high-and low-risk hybrid positive). \n\n 15 kinds of high-risk types, including HPV16, 18,31,33,35,39,45,51,52,53,56,58,59,66,68 \n\n ", - "exclusion_criteria": ": \n\n (1) cervical intraepithelial neoplasia (CIN); (2), combined with a severe fungal, trichomonas vaginitis; (3), severe primary diseases associated with cardiovascular, liver, kidney and hematopoietic system; (4), allergies or allergy to the drug known ingredients. (5), within 30 days to accept other clinical trials of drugs or are participating in clinical trials; (6), pregnant and lactating women and to be pregnant women; (7), the researchers do not consider it appropriate clinical trials.", - "brief_summary": "to assess the efficacy and safety of recombinant human interferon \u03b1-2b gel (Yallaferon\u00ae) for the treatment of patients with cervical high-risk HPV infections; to analyze the HPV type infections and clinical negative conversion.~285 patients with positive high risk HPV infection were randomized into interferon gel group and control group at ratio of 2:1 (203 patients in treatment group and 82 patients in control group). The patients in treatment group received 1g recombinant human \u03b1-2b interferon gel every other day for consecutive 3 courses of treatment, whereas no treatment was conducted in control group.", - "NCTID": "NCT01824992" - }, - { - "brief_title": "Evaluation of ELISA Assay on Human Papilloma Viruses (HPV) Infection Population", - "phase": "", - "drugs": "['peripheral blood isolation']", - "drugs_list": [ - "peripheral blood isolation" - ], - "diseases": "['Patient With Invasive Cervical Carcinoma', 'Patient With CIN Lesion', 'Patient With HPV Infected Patients Without Histopathologic Lesion', 'Normal Populations.']", - "diseases_list": [ - "Patient With Invasive Cervical Carcinoma", - "Patient With CIN Lesion", - "Patient With HPV Infected Patients Without Histopathologic Lesion", - "Normal Populations." - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy volunteers \n\n People infected with HPV type 16 but without CIN lesions \n\n Patients with CIN lesions \n\n Patients with cervical cancer from National Taiwan University Hospital \n\n Informed consent is obtained, and the protocols are reviewed and approved by the appropriate Investigative Review Boards", - "exclusion_criteria": "", - "brief_summary": "Cervical cancer the most frequent neoplasm and the fifth mortality rate of malignancies of the women in the world. It results in about 1,000 women in Taiwan and about 200,000 women worldwide dying of cervical cancer each year. Human papilloma viruses (HPV) have been consistently implicated in causing cervical cancer especially those high-risk types (HPV 16,18,31,45) have been strongly associated with cervical cancer. Around 50-80 % of women are infected by HPV within their whole lives. However, only 1% of HPV-infected women have cervical cancer eventually. Seventy and 91% of HPV infection could be cleaned up by host immune responses within 1 and 2 years later. It shows that host immunity plays an important role in the progression, persistence, or regression of HPV infection.~There are two main defense lines in the host immunity including innate immunity and adoptive immunity. Adoptive immunity plays more important roles in the defense of HPV infections than innate immunity. The adoptive immunity could be further divided into humoral immunity and cell-mediated immunity. Humoral immunity regulated by Th2 helper T lymphocytes to generate memory B cells to produce antibody which provide the protective function to HPV infection. Cell-mediated immunity regulated by Th1 helper T lymphocytes to induce antigen-specific cytotoxic T cells which could kill the HPV-infected cells. Although there are many researches focused on the immunity to HPV infection, there is no conclusion about the relationship between humoral and cell-mediated immunities on HPV infection and roles of humoral and cell-mediated immunities in the prognosis of HPV-infected population and cervical cancer patients.~Our research team has focused on the establishment of platforms on cell-mediated immunity to HPV infection and on the correlation of cell-mediated immunity and prognosis of HPV-infected population and cervical cancer patients for years. In order to survey the host immunity to HPV infection more comprehensively, we propose this proposal. First, we would like to set up the platforms to elucidate the humoral immunity to HPV infection in normal population and patients with CIN lesion or cervical cancer. Second, we would to survey the correlation betweem humoral immunity and status and clinico-pathologic items of HPV-infected populations. Our research results will have a more comprehensive overview in the host immunity to HPV infection and its related diseases. It could provide more information in the prevention and treatment of HPV infection in the future.", - "NCTID": "NCT00673192" - }, - { - "brief_title": "Screening and Identification of Biomarkers on Cervical Cancers", - "phase": "", - "drugs": "['surgery']", - "drugs_list": [ - "surgery" - ], - "diseases": "['Cervical Cancer']", - "diseases_list": [ - "Cervical Cancer" - ], - "enrollment": "250.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy volunteers \n\n People infected with HPV type 16 but without CIN lesions \n\n Patients with CIN lesions \n\n Patients with cervical cancer from National Taiwan University Hospital \n\n Informed consent is obtained, and the protocols are reviewed and approved by the appropriate Investigative Review Boards. \n\n ", - "exclusion_criteria": ": \n\n None", - "brief_summary": "Cervical cancer the most frequent neoplasm and the fifth mortality rate of malignancies of the women in the world. It results in about 1,000 women in Taiwan and about 200,000 women worldwide dying of cervical cancer each year. Human papilloma viruses (HPV) have been consistently implicated in causing cervical cancer especially those high-risk types (HPV 16,18,31,45) have been strongly associated with cervical cancer. Around 50-80 % of women are infected by HPV within their whole lives. However, only 1% of HPV-infected women have cervical cancer eventually. Seventy and 91% of HPV infection could be cleaned up by host immune responses within 1 and 2 years later. It shows that host immunity plays an important role in the progression, persistence, or regression of HPV infection.~There are two main defense lines in the host immunity including innate immunity and adoptive immunity. Adoptive immunity plays more important roles in the defense of HPV infections than innate immunity. The adoptive immunity could be further divided into humoral immunity and cell-mediated immunity. Humoral immunity regulated by Th2 helper T lymphocytes to generate memory B cells to produce antibody which provide the protective function to HPV infection. Cell-mediated immunity regulated by Th1 helper T lymphocytes to induce antigen-specific cytotoxic T cells which could kill the HPV-infected cells. Although there are many researches focused on the immunity to HPV infection, there is no conclusion about the relationship between humoral and cell-mediated immunities on HPV infection and roles of humoral and cell-mediated immunities in the prognosis of HPV-infected population and cervical cancer patients.~Our research team has focused on the establishment of platforms on cell-mediated immunity to HPV infection and on the correlation of cell-mediated immunity and prognosis of HPV-infected population and cervical cancer patients for years. In order to survey the host immunity to HPV infection more comprehensively, we propose this 3-year proposal. First, we would like to set up the platforms to survey the humoral immunity to HPV infection in normal population and patients with CIN lesion or cervical cancer. Second, we would to elucidate the correlation between humoral immunity and status and clinico-pathologic items of HPV-infected populations. Third, we would like to survey if the humoral immunity correlate with the prognosis of patients with cervical lesions. Fourth, we would like to elucidate the correlation betweenHLA haplotype and humoral immunity in HPV-infected populations. Our research results will have a more comprehensive overview in the host immunity to HPV infection and its related diseases. It could provide more information in the prevention and treatment of HPV infection in the future.", - "NCTID": "NCT00854269" - }, - { - "brief_title": "Clinical Evaluation of the APTIMA\u00ae HPV Assay Using the PANTHER\u2122 System", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Human Papilloma Virus Infection']", - "diseases_list": [ - "Human Papilloma Virus Infection" - ], - "enrollment": "11816.0", - "inclusion_criteria": "inclusion criteria: \n\n the sample had an aliquot with a valid positive or negative APTIMA HPV Assay TIGRIS System result (from testing under protocol 2007HPVASCUS30) \n\n an aliquot is available and suitable for testing, and \n\n the sample was randomly selected for inclusion. \n\n ", - "exclusion_criteria": ": \n\n sample integrity was compromised (eg, stored under unacceptable conditions)", - "brief_summary": "The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.", - "NCTID": "NCT01446198" - }, - { - "brief_title": "Follow-up Study to Evaluate the Long-term Efficacy of the HPV Vaccine (580299) in Healthy Young Adult Women in Brazil", - "phase": "Phase 2", - "drugs": "['Blood sampling', 'Collection of cervical specimen', 'Cervarix']", - "drugs_list": [ - "Blood sampling", - "Collection of cervical specimen", - "Cervarix" - ], - "diseases": "['Infections, Papillomavirus']", - "diseases_list": [ - "Infections", - "Papillomavirus" - ], - "enrollment": "433.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. \n\n Subjects who participated in study 580299-007. \n\n Written informed consent obtained from the subject prior to enrollment. \n\n ", - "exclusion_criteria": ": \n\n Use or planned use of any investigational or non-registered product other than the study vaccine. \n\n Decoding of the subject's 580299-001 treatment allocation to either the subject or the investigator. \n\n Administration or planned administration of any other HPV vaccine, other than the vaccine administered in study 580299-001.", - "brief_summary": "Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IIb study is designed to evaluate the the long-term efficacy, safety and immunogenicity of the 580299 HPV vaccine (CervarixTM) in a Brazilian cohort of women vaccinated in the phase IIb, blinded, primary study 580299/001 (NCT00689741) and having participated in follow-up study 580299/007 (NCT00120848). Only subjects who participated in the primary & follow-up study will be enrolled in this long-term follow-up study. Subjects were aged 15-25 years at the time of entry into the primary study.~The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.", - "NCTID": "NCT00518336" - }, - { - "brief_title": "Knowledge and Perceptions About Human Papillomavirus and Cervical Cancer Risk Among Young Adults", - "phase": "", - "drugs": "['survey administration']", - "drugs_list": [ - "survey administration" - ], - "diseases": "['Cervical Cancer', 'Precancerous Condition']", - "diseases_list": [ - "Cervical Cancer", - "Precancerous Condition" - ], - "enrollment": "0.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Currently enrolled in a college, university, or community college in the Greater Cleveland metropolitan area \n\n Currently single and never married \n\n PATIENT CHARACTERISTICS: \n\n Not specified \n\n PRIOR CONCURRENT THERAPY: \n\n Not specified", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Learning about young adults' knowledge and perceptions about risk factors for the human papilloma virus and cervical cancer may help doctors learn more about how to prevent human papilloma virus infection and cervical cancer in the future.~PURPOSE: This clinical trial is studying knowledge and perceptions of the risk factors for human papilloma virus infection and cervical cancer in young adults.", - "NCTID": "NCT00736216" - }, - { - "brief_title": "Hybrid Capture Test on Mobile Unit Program to Improve Cervical Cancer Screening in Brazilian Rural and Remote Areas", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cervical Cancer Squamous Cell', 'Human Papilloma Virus Infection', 'Human Papilloma Virus-Related Carcinoma', 'Prevention']", - "diseases_list": [ - "Cervical Cancer Squamous Cell", - "Human Papilloma Virus Infection", - "Human Papilloma Virus-Related Carcinoma", - "Prevention" - ], - "enrollment": "5079.0", - "inclusion_criteria": "inclusion criteria: \n\n Any women who come to do the Papanicolaou test at the Barretos Cancer Hospital and in the mobile units on the remote Brazilian areas. \n\n ", - "exclusion_criteria": ": \n\n not applicable.", - "brief_summary": "This study evaluates the women cervical samples through molecular tests in order to:~1. Deploy the test careHPV (hybrid capture test) in mobile unities of the Barretos Cancer Hospital to evaluate their performance;", - "NCTID": "NCT01539668" - }, - { - "brief_title": "Community Awareness, Resources and Education (CARE I): Project 3", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cervical Abnormality']", - "diseases_list": [ - "Cervical Abnormality" - ], - "enrollment": "2394.0", - "inclusion_criteria": "inclusion criteria: \n\n Female \n\n 18 years or older \n\n Able to give informed consent \n\n Intact cervix \n\n No prior history of invasive cervical cancer \n\n English speaking \n\n Willing to have biological specimens stored for future studies \n\n Resident of Appalachian Ohio \n\n ", - "exclusion_criteria": ": \n\n Pregnant \n\n Medical or psychiatric illness that precludes research project requirements, ability to give informed consent, or protocol compliance. \n\n Smokers (will be contacted by study team to see if they are eligible/willing to participate in CARE: Project 2", - "brief_summary": "Community Awareness, Resources and Education (CARE) Project - Project 3 will determine if Appalachian women have unique risk factors for an abnormal Pap smear that might contribute to the increased risk of cervical abnormalities, specifically cancer, in their communities.", - "NCTID": "NCT02113514" - } - ], - "2": [ - { - "brief_title": "APTIMA HPV 16 18/45 Genotype Assay on the TIGRIS DTS System in Women With ASC-US or Negative Pap Test Results", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Human Papillomavirus Infection']", - "diseases_list": [ - "Human Papillomavirus Infection" - ], - "enrollment": "1260.0", - "inclusion_criteria": "inclusion criteria: \n\n \u2022 the subject attended a colposcopy visit, and \n\n the referral Pap sample had a valid APTIMA HPV Assay result, and \n\n the sample had an APTIMA HPV Assay positive result, or \n\n the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of cervical intraepithelial neoplasia (CIN) grade 2 [CIN2] or more severe (eg, CIN2, CIN grade 3 [CIN3], or cervical cancer; CIN2+), or \n\n the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of normal or CIN grade 1 (= 18 years of age \n\n Intact cervix \n\n Not pregnant \n\n Able to provide informed consent \n\n ", - "exclusion_criteria": ": \n\n < 18 years of age \n\n Pregnant at screening \n\n Cervix not intact \n\n not able to provide informed consent", - "brief_summary": "RATIONALE: Finding certain changes in genes may help doctors predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer and may help the study of cancer in the future.~PURPOSE: This clinical trial is studying genes that may predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer.", - "NCTID": "NCT00458562" - }, - { - "brief_title": "An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus Types in Women in Egypt", - "phase": "", - "drugs": "['Endocervical samples']", - "drugs_list": [ - "Endocervical samples" - ], - "diseases": "['Human Papillomavirus Infection']", - "diseases_list": [ - "Human Papillomavirus Infection" - ], - "enrollment": "490.0", - "inclusion_criteria": "inclusion criteria: \n\n Women >= 18 years of age attending a clinic for gynaecological examination. \n\n Women who agree to provide a cervical sample for human papillomavirus testing. \n\n Written informed consent obtained from the subject. \n\n ", - "exclusion_criteria": ": \n\n Referral for abnormal cervical sample at the current visit. \n\n Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed. \n\n History of hysterectomy. \n\n Known diagnosis of immunosuppression, or patient on immunosuppressives. \n\n Pregnant women. \n\n Having received one or more doses of HPV vaccine prior to participating in the study.", - "brief_summary": "The purpose of the study is to determine the Human Papillomavirus (HPV) prevalence and HPV type distribution among women aged >= 18 years, attending out-patient health services for gynaecological examination and who agree to HPV testing in Egypt .", - "NCTID": "NCT01158209" - }, - { - "brief_title": "European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System", - "phase": "", - "drugs": "['BD HPV assay on Viper LT']", - "drugs_list": [ - "BD HPV assay on Viper LT" - ], - "diseases": "['Uterine Cervical Neoplasms']", - "diseases_list": [ - "Uterine Cervical Neoplasms" - ], - "enrollment": "1365.0", - "inclusion_criteria": "inclusion criteria: \n\n Referred to follow up due to one or more abnormal Pap or an HPV infection \n\n Subjects who have provided informed consent \n\n Subjects who meet the minimum age set forth by the ethics committee (EC) and/or national screening guidelines. \n\n ", - "exclusion_criteria": ": \n\n Known to be pregnant \n\n With prior complete or partial hysterectomy involving removal of cervix \n\n Subjects with an application of chemical compounds to the cervical area 24 hour prior to study entry- this includes acetic acid, iodine, spermicide, douche, anti-fungal meds. \n\n Subjects on who conization, Loop electrosurgical excision procedure (LEEP), laser surgery or cryosurgery has been performed.", - "brief_summary": "The purpose of the study is to compare the results of the Becton Dickinson (BD) Human Papilloma Virus (HPV) Assay on the Viper LT instrument from SurePath media diluted in HPV diluent (pre-quot and/or residual), PreservCyt media diluted in HPV diluent (pre-quot and/or residual) and a BD cervical brush in BD transport medium to reference histology results from biopsy.", - "NCTID": "NCT01671462" - }, - { - "brief_title": "Study on the Prevalence of Human Papillomavirus Types in Women >= 15 Years of Age in the Kingdom of Saudi Arabia", - "phase": "", - "drugs": "['Cervical samples', 'Data collection']", - "drugs_list": [ - "Cervical samples", - "Data collection" - ], - "diseases": "['Infections, Papillomavirus', 'Cervical Cancer']", - "diseases_list": [ - "Infections", - "Papillomavirus", - "Cervical Cancer" - ], - "enrollment": "420.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects/Subjects' parents or guardians, who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study, \n\n Women >=15 years of age attending a clinic for routine cervical screening, \n\n Written informed consent obtained from the subject and/or subject's parent/guardian. \n\n ", - "exclusion_criteria": ": \n\n Referral for abnormal cervical sample at the current visit, \n\n Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed, \n\n No cervical sample provided, \n\n History of hysterectomy, \n\n Known diagnosis of immunosuppression, or patient on immunosuppressives, \n\n Pregnant female >=25 years of age.", - "brief_summary": "This study aims to determine the prevalence of human papillomavirus (HPV) and to assess the HPV type distribution among women >= 15 years of age, attending routine gynaecological examination in the Kingdom of Saudi Arabia.", - "NCTID": "NCT01213459" - }, - { - "brief_title": "Pap Smear Research Study", - "phase": "", - "drugs": "['Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16)']", - "drugs_list": [ - "Diagnostic cervical cancer screening tests (Pap smear", - "HPV and/or p16)" - ], - "diseases": "['Cervical Cancer']", - "diseases_list": [ - "Cervical Cancer" - ], - "enrollment": "1712.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years and older \n\n Ability to speak and clearly understand English \n\n Female patients \n\n ", - "exclusion_criteria": ": \n\n No previous history of Cervical Cancer Treatment(LEEP,Laser,Cone etc.) \n\n Women who have had Pap smears within the previous 10 months \n\n Women under the age of 18. \n\n Women who are pregnant. \n\n Inability to give informed consent in English", - "brief_summary": "The principal hypothesis of this study is that HPV testing and/or p16 testing, either alone or in combination or associated with a Pap smear, will demonstrate greater specificity for clinically significant precancerous disease than will a Pap smear alone and that these tests will be of comparable or superior sensitivity than the Pap smear.", - "NCTID": "NCT00743626" - } - ] - }, - { - "patient_id": "sigir-201518", - "patient": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", - "0": [ - { - "brief_title": "Heart Failure in the Community", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cardiovascular Diseases', 'Heart Diseases', 'Heart Failure', 'Coronary Disease', 'Diabetes Mellitus', 'Hypertension', 'Obesity']", - "diseases_list": [ - "Cardiovascular Diseases", - "Heart Diseases", - "Heart Failure", - "Coronary Disease", - "Diabetes Mellitus", - "Hypertension", - "Obesity" - ], - "enrollment": "", - "inclusion_criteria": "No eligibility criteria", - "exclusion_criteria": "", - "brief_summary": "To monitor trends in congestive heart failure in Olmsted County, Minnesota.", - "NCTID": "NCT00053534" - }, - { - "brief_title": "Lifestyle Intervention for Heart Failure", - "phase": "", - "drugs": "['Usual Care', 'Exercise Training', 'Dietary Counseling']", - "drugs_list": [ - "Usual Care", - "Exercise Training", - "Dietary Counseling" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "85.0", - "inclusion_criteria": "inclusion criteria: \n\n diagnosis of NYHA I, II or III heart failure (as identified by any of the following physical findings of heart failure (jugular venous distension, crackles, edema, S3); pulmonary edema on chest x-ray; BNP > 100 pg/ml; or at least two of the following symptoms: paroxysmal nocturnal dyspnea, shortness of breath, swelling, fatigue; \n\n previous chemotherapy that contributed to the development of heart failure (i.e., heart failure develops or worsens after receiving chemotherapy, with no other obvious explanation); \n\n oriented to person, place, and time; \n\n living in the Houston area (Harris county or a contiguous county), or planning to stay in the area for at least the next 16 weeks. \n\n 18 years of age or older. \n\n diagnosis of cancer \n\n have completed treatment, or are on long-term adjuvant or maintenance chemotherapy only \n\n ", - "exclusion_criteria": ": \n\n remain in NYHA class IV heart failure despite therapy; \n\n have health problems or current treatments that would make exercise unsafe, as determined by the cardiologist; \n\n cannot provide informed consent;", - "brief_summary": "The goal of this behavioral research study is to learn if education and training about exercise can help to change the lifestyle of cancer survivors with symptoms of heart failure.", - "NCTID": "NCT00633633" - }, - { - "brief_title": "Interleukin-1 Blockade in Recently Decompensated Heart Failure", - "phase": "Phase 2; Phase 3", - "drugs": "['Anakinra (weeks 1-2)', 'Anakinra (weeks 3-12)', 'Placebo']", - "drugs_list": [ - "Anakinra (weeks 1-2)", - "Anakinra (weeks 3-12)", - "Placebo" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n All 6 criteria need to be met for enrollment of the patient in the study \n\n Primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of all 2 conditions listed below: \n\n dyspnea or respiratory distress or tachypnea at rest or with minimal exertion; \n\n evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met); \n\n pulmonary congestion/edema at physical exam OR chest X-Ray; \n\n plasma Brain Natriuretic Peptide (BNP) levels \u2265200 pg/ml; \n\n invasive measurement of left ventricular end-diastolic pressure >18 mmHg or of pulmonary artery occluding pressure (wedge) >16 mmHg. \n\n The patient has a prior documentation of impaired left ventricular systolic function (ejection fraction <50%) at most recent assessment by any imaging modality (within 12 months). \n\n The patient is now clinically stable and meets standard criteria for hospital discharge as documented by all the 3 conditions listed below: \n\n absence of dyspnea or pulmonary congestion/distress at rest; \n\n absence of pitting edema in the lower extremities, or in any other region; \n\n stable hemodynamic parameters (blood pressure, heart rate). \n\n The patient is of age \u226521 years old, and is willing and able to provide written informed consent. \n\n The patient is willing and able to comply with the protocol (i.e. self administration of the treatment, and exercise protocol). \n\n The patient has screening plasma C-reactive protein levels >2 mg/L. \n\n ", - "exclusion_criteria": " Subjects will not be eligible if they meet any of the following 15 ", - "brief_summary": "The RED-HART is a randomized double-blinded placebo-controlled study of Anakinra (IL-1 blocker) in patients with recently decompensated heart failure to determine the safety and efficacy in terms of aerobic exercise capacity and ventilatory efficiency measured with a cardiopulmonary exercise test.", - "NCTID": "NCT01936909" - }, - { - "brief_title": "Hospitalization at Home of Elderly Patients With Heart Failure", - "phase": "", - "drugs": "['Treatment of elderly patients in a GMW', 'Treatment of elderly patients in GHHS']", - "drugs_list": [ - "Treatment of elderly patients in a GMW", - "Treatment of elderly patients in GHHS" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "101.0", - "inclusion_criteria": "inclusion criteria: \n\n Acute exacerbation of chronic heart failure, \n\n Age over 75, \n\n Appropriate care supervision at home, \n\n Telephone connection, \n\n Living in the hospital-at-home catchment area and informed consent. \n\n ", - "exclusion_criteria": ": \n\n Absence of family and social support; \n\n Patients who need mechanical ventilation, \n\n Severe dementia, \n\n End-stage cancer, \n\n History of severe renal impairment or hepatic failure with ascitis.", - "brief_summary": "Aim of the study was to evaluate the efficacy of hospital-at-home treatment compared with inpatient care in selected elderly patients with acute exacerbation of chronic heart failure (CHF).", - "NCTID": "NCT00623571" - }, - { - "brief_title": "Congestive Heart Failure Trends in the Elderly 1970-94", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cardiovascular Diseases', 'Heart Diseases', 'Heart Failure, Congestive', 'Heart Failure']", - "diseases_list": [ - "Cardiovascular Diseases", - "Heart Diseases", - "Heart Failure", - "Congestive", - "Heart Failure" - ], - "enrollment": "", - "inclusion_criteria": "No eligibility criteria", - "exclusion_criteria": "", - "brief_summary": "To investigate trends in the incidence and survival rates of congestive heart failure (CHF) in two successive cohorts of elderly people (1970-74, 1990-94) in a health maintenance organization (HMO).", - "NCTID": "NCT00005499" - }, - { - "brief_title": "Feasibility of Pharmaceutical Interventions in Elderly Heart Failure Patients.", - "phase": "", - "drugs": "['heart-failure related pharmaceutical intervention']", - "drugs_list": [ - "heart-failure related pharmaceutical intervention" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "29.0", - "inclusion_criteria": "inclusion criteria: \n\n 75 years or older \n\n diagnosis of previous or new heart failure based on signs and symptoms as defined by the 'European Society of Cardiology guidelines on acute and chronic heart failure' \n\n diagnosis had to be confirmed by a recent echocardiogram \n\n ", - "exclusion_criteria": ": \n\n not Dutch speaking \n\n treatment restrictions had been applied on admission", - "brief_summary": "Heart failure therapies (e.g. beta blockers) have been successful in decreasing mortality rates, as well as diminishing hospitalizations. Also, pharmacist collaboration has been shown to have a beneficial impact on heart failure related outcomes. Regardless, a high residual event rate is to be noted.~In our pilot study, we wished to document whether a clinical pharmacist could still play a role in the heart failure management of an elderly inpatient heart failure population.", - "NCTID": "NCT02149940" - }, - { - "brief_title": "Thiamine Supplementation to Improve Cardiac Function in Patients With Congestive Heart Failure", - "phase": "", - "drugs": "['Thiamine', 'Placebo']", - "drugs_list": [ - "Thiamine", - "Placebo" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with stable congestive heart failure on a prescription for diuretic drugs \n\n ", - "exclusion_criteria": ": \n\n Acute heart failure \n\n Foreseeable need for further changes in medication \n\n Current medication containing vitamins \n\n Patients with a creatinine above 250 \u03bcmol/l", - "brief_summary": "Working Hypothesis: a treatment with thiamine improves functional status and heart function of patients with congestive heart failure when on a diuretic treatment.", - "NCTID": "NCT00770107" - }, - { - "brief_title": "Heart Failure, Functional and Cognitive Decline, and Psychiatric Symptoms in Nursing Home Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Heart Failure, Congestive']", - "diseases_list": [ - "Heart Failure", - "Congestive" - ], - "enrollment": "586.0", - "inclusion_criteria": "inclusion criteria: \n\n All new residents to participating long-term care facilities \n\n Age 65 or over \n\n ", - "exclusion_criteria": ": \n\n Residing in any long-term care facility for more than 8 weeks \n\n Inability or refusal to obtain informed consent \n\n Palliative diagnosis and not expected to survive 6 weeks \n\n Residents admitted for respite care and expected to be returned to the community", - "brief_summary": "Heart failure is very common in the elderly, in whom it may lead to functional and intellectual problems. Functional problems include loss in the ability to perform basic tasks of daily living such as bathing or dressing. No studies have yet described the rate at which heart failure causes these problems to develop. This study aims to find out whether nursing home patients deteriorate more quickly with respect to function and intellect if they have heart failure. Participants will undergo a thorough health history and physical examination and will be followed every 3 months for up to a year. Over 30 nursing homes in Kitchener, Waterloo, Cambridge, and Hamilton, in South Central Ontario (Canada), are participating in this study. Every 3 months, participants will be reviewed with respect to function, intellect, mood and behaviours. Results between those with heart failure will be compared to those of people without heart failure. The results of this study will be used to plan further studies to see whether good treatment of heart failure can preserve function, intellect, and prevent depression and other mood problems.", - "NCTID": "NCT00182065" - }, - { - "brief_title": "Effects of Carvedilol on Health Outcomes in Heart Failure", - "phase": "Phase 4", - "drugs": "['carvedilol plus nurse management']", - "drugs_list": [ - "carvedilol plus nurse management" - ], - "diseases": "['Heart Failure, Congestive']", - "diseases_list": [ - "Heart Failure", - "Congestive" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n primary hospitalization with heart failure and LVEF < 40% \n\n patient informed consent has been obtained \n\n absence of pulmonary congestion \n\n age > 18 years \n\n ", - "exclusion_criteria": ": \n\n End-stage renal or hepatic disease \n\n Acute myocardial infarction as primary diagnosis during index hospitalization \n\n Life-expectancy < 6-months \n\n Contraindication to beta blocker use \n\n Current beta-blocker therapy \n\n Planned bypass or valve surgery during index hospitalization", - "brief_summary": "The purpose of our study was to determine if a strategy of starting a heart medication (Beta-blocker) before patients leave the hospital and then being seen by a nurse manager would reduce subsequent hospitalizations compared to usual care.~Hypothesis: A nurse-directed heart failure management program with inpatient initiation of beta blockers will improve health outcomes in a vulnerable, predominantly Hispanic and African American population.", - "NCTID": "NCT00381030" - }, - { - "brief_title": "Power Spectral Analysis of Breath Sound in Pulmonary Edema", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pulmonary Edema']", - "diseases_list": [ - "Pulmonary Edema" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients in the intensive care unit using ventilator \n\n ", - "exclusion_criteria": ": \n\n Asthma, COPD, non-ventilated patients", - "brief_summary": "Pulmonary edema can be classified into cardiogenic pulmonary edema and non-cardiogenic pulmonary edema according to the underlying etiology. Cardiogenic pulmonary edema is caused by the dysfunction in the cardiac pumping capability, leading to the transudation accumulation in the pulmonary peri-capillary space. The predisposing factors of non-cardiogenic pulmonary edema are numerous, including severe infection, renal failure, auto-immun reaction, etc. The mortality rate of pulmonary edema is relatively high, especially the non-cardiogenic one. To distinguish the type of pulmonary edema at the early stage is important for its treatment.~Lung sound analysis via stethoscope is a simple diagnostic method to lung diseases clinically. Among many kinds of lung sounds, the crackle and rale are frequently found in pulmonary edema. Rale is also called moist rale. It is considered as low-frequency wheezes and is often seen in cardiogenic pulmonary edema. On the other hand, crackle is also called dry rale, which is a kind of high-frequency wheezes and usually seen in Acute Respiratory Distress Syndrome (ARDS) that is classified into non-cardiogenic pulmonary edema.~This proposed project intends to establish a digital diagnostic method for pulmonary edema. The lung sound of patient with pulmonary edema will be collected by the lung sound acquisition system. By identifying the significant spectrum characteristics of cardiogenic pulmonary edema and non-cardiogenic pulmonary edema, the diagnostic system might be established.", - "NCTID": "NCT00767195" - }, - { - "brief_title": "Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Preserved)", - "phase": "Phase 3", - "drugs": "['Candesartan', 'Placebo']", - "drugs_list": [ - "Candesartan", - "Placebo" - ], - "diseases": "['Congestive Heart Failure']", - "diseases_list": [ - "Congestive Heart Failure" - ], - "enrollment": "734.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female aged 18 or above \n\n Congestive Heart Failure with symptoms for more than 4 weeks before starting study \n\n Provision of informed consent \n\n ", - "exclusion_criteria": ": \n\n Current low blood pressure with symptoms \n\n Liver disease considered significant by the study doctor \n\n Pregnant or lactating females", - "brief_summary": "A study to evaluate the effect of Atacand on patients with heart failure with preserved left ventricular function", - "NCTID": "NCT00634712" - }, - { - "brief_title": "A Trial of Fimasartan for Early Diastolic Heart Failure", - "phase": "Phase 4", - "drugs": "['Fimasartan', 'Antihypertensive treatment']", - "drugs_list": [ - "Fimasartan", - "Antihypertensive treatment" - ], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Untreated hypertension: systolic BP \u2265 140 or diastolic BP \u2265 90 mmHg or Treated hypertension \n\n Current heart failure symptoms with NYHA class II \n\n Evidence of diastolic dysfunction showing any 2 of the following: \n\n E/E' > 10, LV posterior wall thickness > 11 mm, BNP level > 40 pg/mL \n\n ", - "exclusion_criteria": ": \n\n Planned cardiac surgery or planned major non-cardiac surgery within the study period \n\n Stroke or coronary revascularization in the past 6 months \n\n LV ejection fraction < 50% \n\n Hypertrophic or restrictive cardiomyopathy, moderate or severe valve disease, constrictive pericarditis \n\n Atrial fibrillation with a heart rate > 120/min \n\n Sitting systolic BP < 100 mmHg \n\n Sitting systolic BP > 160 mmHg or diastolic BP > 95 mmHg despite antihypertensive therapy \n\n Significant renal disease manifested by serum creatinine > 2.5 mg/dL \n\n Clinically significant pulmonary disease, coronary artery disease \n\n A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer \n\n Female of child-bearing potential who do not use adequate contraception and women who are pregnant or breast-feeding", - "brief_summary": "Approximately half of hypertensive patients have diastolic dysfunction and diastolic dysfunction is associated with development of congestive heart failure and increased mortality. Although diastolic heart failure associated with hypertension is a clinically significant problem, few clinical trials have been conducted and there is no proven pharmacological therapy to improve outcomes. To the best of the investigators knowledge, there has been no randomized trial to demonstrate that an antihypertensive drug improves diastolic function in hypertensive patients with diastolic dysfunction. The investigators hypothesize that fimasartan added to standard therapy will be superior to placebo in improving diastolic dysfunction in mildly symptomatic patients with hypertension and diastolic dysfunction, and try to examine this hypothesis in a double-blind, randomized comparison study using echocardiography.", - "NCTID": "NCT01691118" - }, - { - "brief_title": "The Effect of GHRH Therapy on Myocardial Structure and Function in Congestive Heart Failure", - "phase": "Phase 2", - "drugs": "['Growth hormone releasing hormone/ placebo']", - "drugs_list": [ - "Growth hormone releasing hormone/ placebo" - ], - "diseases": "['Congestive Heart Failure']", - "diseases_list": [ - "Congestive Heart Failure" - ], - "enrollment": "3.0", - "inclusion_criteria": "inclusion criteria: \n\n subjects will be at least 50 years of age, \n\n women who are post-menopausal. \n\n clinical evidence of congestive heart failure, with ongoing management by conventional medical therapy \n\n a left ventricular ejection fraction below 40% as measured by echocardiogram performed within 6 months of study enrollment. \n\n Left ventricular end-diastolic dimension greater than 60 mm as measured by an echocardiogram performed within 6 months of study enrollment. \n\n regular heart rate/pacer \n\n hemodynamically stable and able to complete symptom-limited bicycle ergometry exercise test; \n\n and be in New York Heart Association Classification II or III. \n\n ", - "exclusion_criteria": ": \n\n Subjects with hematocrit equal to or less than 33%; \n\n body mass index equal to or greater than 40; \n\n unstable angina within six months; \n\n inducible ischemia by exercise stress testing, radionuclide scintigraphy, or dobutamine echocardiography; \n\n known or suspected myocarditis; \n\n known or suspected restrictive or infiltrative cardiomyopathy; \n\n coronary artery stenosis >70% and < 100% by catheterization should such data be available; \n\n inadequate cardiac echo window; \n\n primary diastolic dysfunction in heart failure \n\n inability to perform cycle ergometry; \n\n critical aortic stenosis; \n\n severe mitral regurgitation by Doppler echocardiography; \n\n uncontrolled or poorly controlled hypertension; \n\n hypertrophic cardiomyopathy; \n\n renal failure, determined by creatinine > 2.0. \n\n untreated thyroid disease; \n\n active alcoholism, \n\n breast cancer; \n\n prostate cancer; \n\n inability to provide informed consent; \n\n uncontrolled hyperlipidemia; (Triglycerides >1200 and/or LDL > 160) \n\n patients with known bleeding disorders; \n\n patients using atropine, artane, scopolamine, and cogentin. \n\n Subjects who have implanted devices that contain metal and are not adherent to the body will be excluded from the MRI testing in this study. These devices include pacemakers, implanted ICD's, infusion pumps, nerve stimulators, metal debris in the eye, or loose metal, such as shrapnel or a bullet. \n\n Inability to lie flat on back for an extended period of time. The MRI testing requires this posture. \n\n History of any noncutaneous malignancy within 5 years of screening. \n\n STUDY TERMINATION CRITERIA: \n\n The following clinical events will define drop-points for worsening clinical conditions and will terminate subject involvement in the study: \n\n Unstable angina \n\n Acute myocardial infarction (chest pain with EKG changes and increased troponin) \n\n NYHA Class IV heart failure for greater than one week (a brief episode of NYHA Class IV heart failure may result from medical or dietary indiscretion, adverse effects of non-study medications, poorly controlled hypertension and other potentially reversible mechanisms) \n\n Documented sustained ventricular tachycardia \n\n Resuscitated cardiac arrest \n\n Unexplained syncope \n\n Diagnosis of sleep apnea that is not medically supervised. \n\n Symptomatic documented bradycardia \n\n Diagnosis of a new non-cutaneous malignancy \n\n Developing ", - "brief_summary": "PP1- The purpose of this study is to determine whether giving more of the hormone produced by everyone called growth hormone releasing hormone (GHRH) can improve heart function in individuals with congestive heart failure. You must be 50 years old or older, have a diagnosis of congestive heart failure, and have a high likelihood of having lower than normal growth hormone effect. GHRH is approved by the US FDA for treatment in children with growth hormone deficiency because GHRH stimulates Growth Hormone (GH). Its use for treatment of congestive heart failure in adults is investigational.~Growth hormone releasing hormone is a hormone produced in the brain. We will be using synthetic hormone made in the laboratory. It is identical to the hormone in the brain.~Many older people, due to aging have low levels of growth hormone. The aim of this study is to find out whether restoring growth hormone levels to the levels found in younger individuals and then maintaining those levels for 12 weeks will help strengthen heard muscles in older persons with congestive heart failure.", - "NCTID": "NCT00791843" - }, - { - "brief_title": "Tai Chi Training for Elderly People With Chronic Heart Failure", - "phase": "", - "drugs": "['Tai Chi training']", - "drugs_list": [ - "Tai Chi training" - ], - "diseases": "['Chronic Heart Failure']", - "diseases_list": [ - "Chronic Heart Failure" - ], - "enrollment": "45.0", - "inclusion_criteria": "inclusion criteria: \n\n Verified diagnosis of heart failure \n\n Left ventricle ejection fraction < 50 \n\n Stable medical treatment with Angiotensin Converting Enzyme blockers and Betareceptor blockers (if no contraindications) experience of fatigue according to the Multidimensional Fatigue Inventory \n\n 70 years or older \n\n Swedish speaking \n\n ", - "exclusion_criteria": ": \n\n Instable angina pectoris \n\n Myocardial infarction within the last three months \n\n Cognitive impairment \n\n No experienced fatigue", - "brief_summary": "Physical activity is recommended in the treatment of heart failure. Elderly people demand various forms of physical activity. Tai chi has shown to be an appreciated form of physical activity among elderly, although there is a lack of studies focusing people aged 70 years and older.~The overall goal with the project is to find a form of physical activity that is safe and free from side effects, suitable for elderly people with chronic heart failure. The hypothesis is that for patients participating in tai chi training during three months the degree of self rated fatigue will be reduced and health-related quality of life will increase, compared with a control group receiving ordinary care. The primary aim is to study the effect of tai chi training on fatigue and health-related quality of life. A second aim is to study effects on physical function and levels of brain natriuretic peptide (BNP) in blood plasma. A tertiary aim is to describe the experience of participating in tai chi training.~A mixed methods study is conducted. Fortyfive patients with a verified diagnosis of heart failure in the age of 70 years or older, who experience fatigue according to the Multi Fatigue Inventory (MFI-20), was randomized to intervention or control group. Three groups with 8-9 participants each completed a tai chi training programme twice-weekly for 16 weeks. Data was collected at baseline, directly after the 16 weeks of training, and 6 and 12 months thereafter. The programme is worked out by an expert in Chinese traditional medicine to suit elderly people with chronic heart failure, and the classes were led by experienced leaders. Before the start of the study a small pilot study was conducted to test the feasibility of the programme. A group of seven patients completed the programme for eight weeks without any problems.~If tai chi has a good effect on fatigue, health-related quality of life and physical function, this form of physical activity can be a valuable complement to other medical treatment. Tai chi has a potential to be offered to many patients to a relatively low cost. It can be practiced in groups or in private, and also through internet connection.", - "NCTID": "NCT01294111" - }, - { - "brief_title": "Effects of Losartan on Insulin Resistance in Patients With Heart Failure", - "phase": "Phase 4", - "drugs": "['losartan']", - "drugs_list": [ - "losartan" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "16.0", - "inclusion_criteria": "inclusion criteria: \n\n chronic stable heart failure \n\n ", - "exclusion_criteria": ": \n\n renal dysfunction or under treatment with antidiabetic agents", - "brief_summary": "The purpose of this study is to evaluate the effects of losartan, an ARB, on glucose metabolism and inflammatory cytokines in CHF patients treated with ACE inhibitors.", - "NCTID": "NCT00663377" - }, - { - "brief_title": "The Efficacy of Breathing Exercise With BreatheMAX Device on Airway Secretion Clearance and Lung Function", - "phase": "", - "drugs": "['BreatheMAX (OPEP)', 'BreatheMAX (OIS and OPEP)', 'BreatheMAX (unload and non-oscillated)']", - "drugs_list": [ - "BreatheMAX (OPEP)", - "BreatheMAX (OIS and OPEP)", - "BreatheMAX (unload and non-oscillated)" - ], - "diseases": "['Bronchial Secretion Retention']", - "diseases_list": [ - "Bronchial Secretion Retention" - ], - "enrollment": "28.0", - "inclusion_criteria": "inclusion criteria: \n\n Intubated patients (with and without mechanical ventilator support) with secretion 1.5 ml/h, If the patients are breathing with mechanical ventilation, the PEEP level must be less than 6 centimeter of water and one of following \n\n Clinical and radiologic diagnosis of pulmonary infection \n\n Acute or chronic airway inflammation disease such as pneumonia, bronchiectasis, chronic obstructive pulmonary disease or chronic bronchitis and at least one sign of secretion accumulation in bronchial such as medium-coarse crackle, wheezing, persistent rhonchi and decrease breath sound \n\n Stable of cardiopulmonary function at least 2 days before the study and the patients don't receive the vasopressors drug within 5 days before collects the data \n\n Stable of hydration status or positive fluid balance at least 2 days before collects the data \n\n Ability to breathe or tolerate spontaneously breathing trial with T-piece at least 2 minutes with fraction of inspired oxygen less than 0.4 and without developing hypoxemia \n\n Good conscious and well cooperation \n\n ", - "exclusion_criteria": ": \n\n Pneumothorax (nontreated) \n\n Massive hemoptysis \n\n Acute myocardial infarction (with angina chest pain) \n\n High intracranial pressure (>20 mm Hg) \n\n Major arrhythmia", - "brief_summary": "The efficacy of breathing exercise with oscillated inspiratory loading and oscillated positive expiratory pressure for airway secretion clearance and lung function in intubated patients, both with and without mechanical ventilation dependence", - "NCTID": "NCT02553200" - }, - { - "brief_title": "Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Congestive Heart Failure Receiving Therapy for Breast Cancer", - "phase": "", - "drugs": "['Laboratory Biomarker Analysis']", - "drugs_list": [ - "Laboratory Biomarker Analysis" - ], - "diseases": "['Breast Carcinoma']", - "diseases_list": [ - "Breast Carcinoma" - ], - "enrollment": "162.0", - "inclusion_criteria": "inclusion criteria: \n\n European American patients with DNA available \n\n European American patients who developed CHF and patients who did not develop CHF following a full course of treatment with an anthracycline and bevacizumab \n\n African American cases (based on a drop in left ventricular ejection fraction [LVEF] < 50 or a drop from baseline > 20 points) and African American controls", - "exclusion_criteria": "", - "brief_summary": "This research trial studies whole exome sequencing in finding causative variants in germline deoxyribonucleic acid (DNA) samples from patients with congestive heart failure receiving therapy for breast cancer. Studying samples of germline DNA in the laboratory from patients with congestive heart failure receiving therapy for breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to congestive heart failure.", - "NCTID": "NCT02610426" - }, - { - "brief_title": "Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment", - "phase": "Phase 2", - "drugs": "['KW-3902IV']", - "drugs_list": [ - "KW-3902IV" - ], - "diseases": "['Heart Failure, Congestive', 'Renal Insufficiency']", - "diseases_list": [ - "Heart Failure", - "Congestive", - "Renal Insufficiency" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Stable congestive heart failure \n\n Impaired renal function \n\n Taking oral loop diuretic \n\n ", - "exclusion_criteria": ": \n\n Acutely decompensated (unstable) and end stage heart failure \n\n Diuretics other than loop diuretics \n\n Pregnant or nursing \n\n Inability to follow instructions \n\n Participation in another clinical trial within past 30 days", - "brief_summary": "The purpose of this study is to characterize the safety and tolerability of KW-3902IV and measure its effect on renal function.", - "NCTID": "NCT00159614" - }, - { - "brief_title": "Add-on Effects of Valsartan on Morbi- Mortality (KYOTO HEART Study)", - "phase": "Phase 4", - "drugs": "['Valsartan', 'Non-ARB']", - "drugs_list": [ - "Valsartan", - "Non-ARB" - ], - "diseases": "['Hypertension', 'Ischemic Heart Disease', 'Congestive Heart Failure', 'Stroke']", - "diseases_list": [ - "Hypertension", - "Ischemic Heart Disease", - "Congestive Heart Failure", - "Stroke" - ], - "enrollment": "3031.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of hypertension \n\n Clinical diagnosis of one or more risk factors, such as diabetes, smoking habit, lipid metabolism abnormality, history of ischemic heart disease (IHD) or cerebrovascular disease, obesity (BMI>25), chronic heart failure (NYHA II-III), and electrocardiogram (ECG) abnormality (LVH) \n\n ", - "exclusion_criteria": ": \n\n Patients who have already been administered ARB \n\n Patients with IHD within 6 months after percutaneous coronary intervention(PCI), and who are stable but are going to implement PCI or coronary artery bypass grafting(CABG) \n\n Severe/malignant/secondary hypertensive patients \n\n Pregnant women and women of childbearing potential \n\n History of heart failure, unstable angina, myocardial infarction, PTCA, or CABG within the preceding 6 months \n\n Arrhythmia needed to be treated or accompanied with symptoms, second or third degree AV block \n\n Severe renal impairment (Serum creatinine >3.0 mg/dl) \n\n Severe hepatic impairment (Hepatic failure, Cirrhosis, etc.)", - "brief_summary": "The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients in Japan with hypertension in terms of the morbidity and mortality.", - "NCTID": "NCT00149227" - }, - { - "brief_title": "Effect of Ivabradine and Beta-blockers Combination Versus Beta-blockers Up-titration on Right Ventricular Pacing", - "phase": "Phase 4", - "drugs": "['Ivabradine plus beta-blocker (bisoprolol)', 'betablocker titration']", - "drugs_list": [ - "Ivabradine plus beta-blocker (bisoprolol)", - "betablocker titration" - ], - "diseases": "['Heart Rate Control in ICD Patients With Heart Failure']", - "diseases_list": [ - "Heart Rate Control in ICD Patients With Heart Failure" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 18 years. \n\n Patients with stable chronic heart failure implanted with mono-cameral or bicameral ICD with a home monitoring remote control. \n\n Moderate to severe left ventricular dysfunction (FE \u2264 40%). \n\n Any cause of heart failure was allowed apart congenital heart disease. \n\n Bicameral ICD programmed in DDD or AAI/DDD with AV interval < 300 msec. \n\n Rest ECG heart rate \u226570 bpm; \n\n Sinus rhythm. \n\n In therapy with low-dose of beta-blocker (bisoprolol 1,25-2,5 mg) and with the maximum dose tolerated of angiotensin-converting enzyme inhibitor or blockade of angiotensin II receptor, mineralocorticoid antagonist, antiplatelet and lipid-lowering therapy, unless contraindicated. \n\n ", - "exclusion_criteria": ": \n\n Inability of providing informed consent; \n\n Age < 18 years. \n\n State of pregnancy or lactation. \n\n Recent (<2 months) myocardial infarction; \n\n Contraindications to beta-blockers and ivabradine; \n\n Rest ECG heart rate < 70 bpm; \n\n No sinus rhythm. \n\n Administration of non-dihydropyridinic calcium channels antagonists, digitalis, class I antiarrhythmic drugs, strong inhibitors of cytochrome P450 3A4 at the time of enrollment.", - "brief_summary": "The aim of this prospective, randomized and controlled trial is to evaluate the use of the ivabradine in combination to a low-dose of beta-blocker (bisoprolol) versus up-titration of beta-blocker (bisoprolol) to obtain heart rate (HR) control with reduction in RV pacing in single-chamber or dual chambers ICD recipients HF patients with moderate to severe left ventricular dysfunction (FE \u2264 40%) and an heart rate \u2265 70 bpm in sinus rhythm over a 12-months follow up.~Besides the investigators want to assess if the combination of ivabradine to a low-dose of beta-blocker (bisoprolol) versus up-titration of beta-blocker (bisoprolol) may determine a lower degree of left ventricular dysfunction progression, the reduction of ventricular arrhythmias burden and ICD appropriate therapy occurrence and the improvement of quality of life in ICD heart failure patients.", - "NCTID": "NCT01868880" - }, - { - "brief_title": "RESynchronizaTiOn theRapy and bEta-blocker Titration", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Beta Blocker Intolerance', 'Congestive Heart Failure']", - "diseases_list": [ - "Beta Blocker Intolerance", - "Congestive Heart Failure" - ], - "enrollment": "254.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients on optimal therapy for heart failure (diuretics, ACE inhibitors and aldosterone antagonists), with stable dose in the previous month; \n\n Successfully implanted with CRT-D according to current European Society of Cardiology (ESC) guidelines; \n\n New York Heart Association (NYHA) functional class: II, III and IV; \n\n Left Ventricular Ejection Fraction (LVEF) \u2264 35%; \n\n Duration of ventricular depolarization wave (QRS) \u2265 120ms (NYHA III or IV) or \u2265 150ms in NYHA II; \n\n Patients with chronic atrial fibrillation will be eligible for the study only if they undergo ablation ; \n\n 18 years or above \n\n ", - "exclusion_criteria": ": \n\n Failure to comply with the scheduled follow-up; \n\n Life expectancy less than 12 months ; \n\n Pregnant women; \n\n Tricuspid valve mechanics; \n\n Severe aortic stenosis or other valve disease ; \n\n Patients already receiving CRT.", - "brief_summary": "Patients will be treated according to the clinical practice of the participating centers and to the international guidelines for the treatment of heart failure.The present analysis provides a collection of data about the changes to drug therapy after the Cardiac Resynchronization Therapy (CRT) procedure , and any signs and symptoms of intolerance to prescribed medications.", - "NCTID": "NCT02173028" - }, - { - "brief_title": "Breath Analysis in Obstructive Sleep Apnoea", - "phase": "", - "drugs": "['Placebo-CPAP device', 'CPAP']", - "drugs_list": [ - "Placebo-CPAP device", - "CPAP" - ], - "diseases": "['Obstructive Sleep Apnoea (OSA)']", - "diseases_list": [ - "Obstructive Sleep Apnoea (OSA)" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI) of >20/h. \n\n Currently >20/h oxygen desaturations (\u22654% dips) during an ambulatory nocturnal pulse oximetry performed on the last night of a 4-night period without CPAP. \n\n Treated with CPAP for more than 12 months, minimum compliance 4h/night, apnoea-hypopnoea index (AHI) <10 with treatment (according to CPAP- download) and current ESS <10. \n\n Age between 20 and 75 years at trial entry. \n\n ", - "exclusion_criteria": ": \n\n Previous ventilatory failure (awake SpO2 <93% and PaCO2>6kPa). \n\n Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension or hypotension (>180/110 or <90/60mmHg) \n\n Previously diagnosed with Cheyne-Stokes breathing. \n\n Current professional driver; any previous sleep related accident. \n\n Acute inflammatory disease. \n\n Acute or chronic hepatic disease. \n\n Renal failure or renal replacement therapy. \n\n Use of inhaled drugs.", - "brief_summary": "Clinical trial in patients with obstructive sleep apnoea that are randomised to either continue or withdraw continuous positive airway pressure therapy to identify a disease-specific exhaled breath pattern by mass spectrometry.", - "NCTID": "NCT02050425" - }, - { - "brief_title": "Rituximab in Rheumatoid Arthritis Lung Disease", - "phase": "Phase 3", - "drugs": "['Rituximab']", - "drugs_list": [ - "Rituximab" - ], - "diseases": "['Rheumatoid Arthritis', 'Interstitial Pneumonia']", - "diseases_list": [ - "Rheumatoid Arthritis", - "Interstitial Pneumonia" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of RA according to the revised 1987 American Rheumatism Association criteria \n\n Absence of clinical features suggesting infection, neoplasm, sarcoidosis, interstitial lung disease other than UIP or NSIP, other collagen vascular disease, or exposure to known fibrogenic drugs or environmental factors \n\n Diagnosis of progressive interstitial pneumonia of UIP or NSIP subtype, based on the following criteria \n\n Clinical symptoms consistent with interstitial lung disease with onset between 3 months and 36 months prior to screening. \n\n Worsening as demonstrated by any one of the following within the past year: \n\n > 10% decrease in Forced Vital Capacity (FVC) \n\n increasing infiltrates on chest X-ray or High Resolution Computed Tomography (HRCT), or worsening dyspnea at rest or on exertion \n\n Diagnosis of UIP or NSIP by either of the following: \n\n Open or video-assisted thoracic surgery (VATS) lung biopsy showing definite or probable UIP or NSIP \n\n HRCT scan showing definite or probable UIP or NSIP AND abnormal pulmonary function tests (reduced FVC or decreased diffusing capacity of carbon monoxide (DLco) or impaired gas exchange at rest or with exercise) AND insidious onset of otherwise unexplained dyspnea or exertion and bibasilar, inspiratory crackles on auscultation \n\n FVC > 50% of predicted value at Screening \n\n DLco >30% of predicted value at Screening \n\n 5. No change of disease-modifying anti-rheumatic drug (DMARD) treatment within the last 3 months \n\n ", - "exclusion_criteria": ": \n\n History of clinically significant environmental or drug exposure known to cause pulmonary fibrosis. \n\n Forced expiratory volume in one second (FEV1) FEV1/FVC ratio < 0.6 at screening (pre- or post-bronchodilator). \n\n Residual volume > 120% predicted at Screening \n\n Evidence of active infection \n\n Any pulmonary condition other than UIP/NSIP, which, in the opinion of the site principal investigator, is likely to result in the death of the patient within the next year \n\n History of unstable or deteriorating cardiac or neurologic disease \n\n Pregnancy or lactation \n\n Treatment with cyclophosphamide, cyclosporine, interferon gamma or beta, anti-tumor necrosis factor therapy, anti-interleukin 1 (IL1) therapy or with endothelin receptor blockers within the last 8 weeks; experimental therapy for rheumatoid arthritis \n\n Creatinine > 1.5 X upper limit of normal range (ULN) at Screening \n\n Hematology outside of specified limits: white blood cell (WBC) < 2,500/mm^3 or absolute neutrophil count (ANC) < 1500 \n\n Hematocrit < 27% or > 59%, platelets < 100,000/mm^3 at screening \n\n Positive hepatitis B or C serology \n\n Any medical condition, which in the opinion of the site principal investigator, may be adversely affected by the participation in this study \n\n History of recurrent significant infection or history of recurrent bacterial infections \n\n Known active bacterial, viral fungal mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening \n\n Abnormal neurological examination reflective of central nervous disease, including paresis, cognitive impairment and problems with coordination \n\n Current enrollment in another clinical trial \n\n Fever (>99.5\u00ba F) \n\n History of previous rituximab administration \n\n Receipt of any vaccine, particularly live viral vaccines, within 4 weeks of first study dose \n\n Decreased Immunoglobulin G (IgG) and Immunoglobulin M (IgM) levels (below lower limit of normal range) \n\n Present or past malignancy \n\n History of severe allergic or anaphylactic reaction to administration of humanized or murine monoclonal antibodies \n\n Positive human immunodeficiency virus (HIV) serology", - "brief_summary": "This study will examine the course of patients with progressive rheumatoid arthritis associated interstitial lung disease (RA-ILD) treated with rituximab for safety and progression-free survival at 48 weeks. Safety of rituximab therapy in this disease will be assessed through patient history, physical exams and laboratory parameters.~Twelve male/or female patient with RA-associated lung disease (6 of each nonspecific interstitial pneumonia (NSIP) and usual interstitial pneumonia (UIP) histological subtype) will be enrolled~The study involves 12 visits over 48 weeks~Rituximab will be administered intravenously at Day 1 and Day 15 with repeat dosing at six months.", - "NCTID": "NCT00578565" - }, - { - "brief_title": "Sleep-disordered Breathing in Eisenmenger Syndrome", - "phase": "", - "drugs": "['Polysomnography']", - "drugs_list": [ - "Polysomnography" - ], - "diseases": "['Eisenmenger Syndrome', 'Congenital Heart Disease', 'Sleep-disordered Breathing']", - "diseases_list": [ - "Eisenmenger Syndrome", - "Congenital Heart Disease", - "Sleep-disordered Breathing" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Eisenmenger Syndrome (definition: Pulmonary \u2265 systemic vascular resistance with pulmonary-to-systemic shunt and cyanosis (periphery oxygen saturation < 92% at rest and/or < 87% during exercise). \n\n Stable for \u2265 3 months (no hospitalization, no change of medication, no deterioration). \n\n ", - "exclusion_criteria": ": \n\n Down's syndrome. \n\n Iron deficiency (definition: Ferritin < 12 \u00b5g/l and/or transferring saturation < 20%). \n\n Regular phlebotomy. \n\n Suspicion of risk of non-compliance.", - "brief_summary": "Sleep-disordered breathing (SDB) is a wellknown comorbidity in cardiovascular disease. Knowledge about SDB in adult congenital heart disease is limited.", - "NCTID": "NCT02614417" - }, - { - "brief_title": "Safety Comparison of Pioglitazone and Glyburide in Type 2 Diabetes Subjects With Mild to Moderate Congestive Heart Failure", - "phase": "Phase 3", - "drugs": "['Pioglitazone', 'Glyburide']", - "drugs_list": [ - "Pioglitazone", - "Glyburide" - ], - "diseases": "['Diabetes Mellitus']", - "diseases_list": [ - "Diabetes Mellitus" - ], - "enrollment": "518.0", - "inclusion_criteria": "inclusion criteria \n\n Females of childbearing potential must be using appropriate birth during the entire duration of the study or must be surgically sterile. \n\n Subjects with a clear diagnosis of type 2 diabetes mellitus using diagnostic criteria of the American Diabetes Association who have been taking a sulfonylurea and/or insulin for at least 30 days prior to Visit 1 or who have been withdrawn from metformin therapy, during the 30 days prior to Visit 1, due to congestive heart failure. \n\n Subjects with a clinical diagnosis of congestive heart failure, New York Heart Association Class II or early Class III. Subjects should not previously have been in Class IV heart failure. \n\n Diagnosis of left ventricular congestive heart failure as evidenced by a left ventricular ejection fraction less than 40% at screening based on an echocardiogram. \n\n Subjects who have demonstrated the need for oral hypoglycemic agents and have participated in dietary counseling. \n\n Glycosylated hemoglobin greater than 7.0% at screening. \n\n Subjects on optimal therapy for congestive heart failure. Medication doses should be stable for at least two weeks prior to randomization. \n\n ", - "exclusion_criteria": " \n\n Na\u00efve to antidiabetic therapy. \n\n Within the past three months were treated with rosiglitazone, pioglitazone HCl, or troglitazone or those previously treated with rosiglitazone, pioglitazone HCl, or troglitazone but discontinued from therapy due to lack of efficacy or clinical or laboratory signs of intolerance. \n\n Type 1 (insulin-dependent) diabetes mellitus or a history of ketoacidosis. \n\n Has taken any other investigational drug during the 30 days prior to Visit 1 or who will receive such a drug during the timeframe of this study. \n\n History of chronic alcoholism or drug abuse during the six months prior to the study. \n\n Has had any of the following within three months prior to Visit 1: myocardial infarction, coronary angioplasty or bypass graft, unstable angina pectoris, transient ischemic attacks, or documented cerebrovascular accident that in the investigator's opinion would warrant exclusion from the study. \n\n Abdominal, thoracic, or vascular surgery during the three months prior to Visit 1 that in the investigator's opinion would warrant exclusion from the study. \n\n Subjects with a planned surgical or catheterization intervention within the six months following Visit 1. \n\n Subjects awaiting cardiac transplantation. \n\n Intercurrent illness severe enough to require hospitalization during the three weeks prior to Visit 1. \n\n Body mass index greater than 48 kg/m2 as calculated by [Weight (kg)/Height (m)2]. \n\n Anemia having a hemoglobin less than 10.5 g/dL for males and less than 10 g/dL for females. \n\n Thyroid stimulating hormone greater than 3.5 mU/L or less than 0.3 mU/L. The thyroid stimulating hormone can be repeated at two months. The subject is eligible if the screening thyroid stimulating hormone is elevated, and the repeat value at two months is less than 3.5 mU/L. \n\n Triglyceride level greater than 500 mg/dL. \n\n Clinical evidence of active liver disease or alanine transaminase levels greater than 1.5 times the upper limit of normal. \n\n Serum creatinine greater than 2.0 mg/dL for males and greater than 1.8 mg/dL for females or urinalysis protein (albumin) excretion greater than 2 plus on Combistix or equivalent (if elevated, may be re-screened in one month). \n\n Unstable coronary syndromes which in the opinion of the investigator would warrant exclusion from the study. \n\n Systolic blood pressure of greater than 150 mmHg or diastolic blood pressure greater than 100 mmHg. \n\n Serious uncontrolled cardiac rhythm disturbances which in the opinion of the investigator would warrant exclusion from the study. \n\n Symptomatic orthostatic hypotension or systolic blood pressure less than 90 mm/Hg. \n\n Severe, advanced peripheral vascular disease (limb threatening ischemia) or claudication resulting in the inability to walk greater than 1 block or to climb 10 stairs without interruption. \n\n Lower extremity amputation. \n\n Any other serious disease or condition at screening or at randomization which might affect life-expectancy or make it difficult to successfully manage and follow the subjects according to the protocol. \n\n Unexplained clinically significant findings on chest x-ray.", - "brief_summary": "The purpose of this study is to compare the safety of Pioglitazone, once daily (QD), to Glyburide in Type 2 Diabetes Subjects with Mild to Moderate Congestive Heart Failure", - "NCTID": "NCT00521820" - }, - { - "brief_title": "Treatment Use of Domperidone for Gastroparesis", - "phase": "", - "drugs": "['Domperidone']", - "drugs_list": [ - "Domperidone" - ], - "diseases": "['Gastroesophageal Reflux Disease', 'GERD', 'Gastroparesis']", - "diseases_list": [ - "Gastroesophageal Reflux Disease", - "GERD", - "Gastroparesis" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Male or female \n\n Age 18 and older \n\n Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy. \n\n Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. \n\n Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including: \n\n increased prolactin levels \n\n extrapyramidal side effects \n\n breast changes \n\n cardiac arrhythmias including QT prolongation and death \n\n There is a potential for increased risk of adverse events with the drugs listed in the domperidone protocol addendum. \n\n ", - "exclusion_criteria": ": \n\n History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded. \n\n Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc> 450 milliseconds for males, QTc>470 milliseconds for females). \n\n Clinically significant electrolyte disorders. \n\n Gastrointestinal hemorrhage or obstruction \n\n Presence of a prolactinoma (prolactin-releasing pituitary tumor). \n\n Pregnant or breast feeding female \n\n Known allergy to domperidone", - "brief_summary": "Domperidone is a drug that may be of benefit to individuals with gastroesophageal reflux disease (GERD), with upper GI symptoms, gastroparesis, and chronic constipation.~This is a long-term treatment program for prescription of this drug to all patients who, in the investigators' judgement, could benefit from its use.", - "NCTID": "NCT02227927" - }, - { - "brief_title": "The Role of Angiotensin Type I Receptor in the Regulation of Human Coronary Vascular Function", - "phase": "Phase 3", - "drugs": "['Angiotensin II type 1 receptor antagonists']", - "drugs_list": [ - "Angiotensin II type 1 receptor antagonists" - ], - "diseases": "['Hypertension', 'Atherosclerosis', 'Heart Failure, Congestive', 'Myocardial Infarction']", - "diseases_list": [ - "Hypertension", - "Atherosclerosis", - "Heart Failure", - "Congestive", - "Myocardial Infarction" - ], - "enrollment": "49.0", - "inclusion_criteria": "Patient must be over 18 years of age requiring diagnostic cardiac catheterization will participate. \n\n Women on chronic estrogen therapy are eligible for the study. \n\n Patients investigated for chest pain syndrome with normal coronary arteries with and without risk factors for atherosclerosis, patients with coronary artery disease, and patients with heart failure. \n\n No patients with unstable angina; significant left main disease (greater than 50% stenosis); Recent myocardial infarction (less than 1 month); Pregnancy, lactation; Allergy to losartan; Renal failure (creatinine greater than 2.5 mg/dl); Inability to withdraw ACE inhibitors.", - "exclusion_criteria": "", - "brief_summary": "The renin angiotensin system (RAS) plays an important physiological and pathophysiological role in the control of blood pressure and plasma volume. Inhibition of the RAS is useful in the treatment of hypertension, cardiac failure and in some patients with myocardial infarction. Several recent clinical trials with angiotensin converting enzyme inhibitors (ACEI) have shown that they also reduce the incidence of myocardial infarction, but the mechanisms underlying this anti-ischemic effect are poorly understood. ACEI reduce angiotensin II synthesis and prevent bradykinin degradation. Results from ongoing studies in the Cardiology Branch (Protocol 95-H-0099) designed to investigate the link between ACEI and the vascular endothelium indicate that ACEI improve both endothelial dysfunction and metabolic coronary vasodilation, an effect that is partially mediated by bradykinin. The current protocol is designed to investigate whether the beneficial effects of ACEI on endothelial function are also partly due to inhibition of angiotensin II. The recent development of selective angiotensin II type 1 (AT1) receptor antagonists allows us to specifically examine the effects of angiotensin II on vasomotor activity.", - "NCTID": "NCT00001629" - }, - { - "brief_title": "A Study to Investigate the Plasma Concentration of YM150 After Repeated Administration to Elderly Subjects", - "phase": "Phase 1", - "drugs": "['YM150', 'Placebo']", - "drugs_list": [ - "YM150", - "Placebo" - ], - "diseases": "['Healthy Elderly Subject', 'Pharmacokinetic of YM150']", - "diseases_list": [ - "Healthy Elderly Subject", - "Pharmacokinetic of YM150" - ], - "enrollment": "36.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and all tests \n\n Body weight: male: \u226545.0 kg, <85.0 kg; female: \u226540.0 kg, <75.0 kg \n\n BMI (at screening): \u226517.6, <30.0 \n\n ", - "exclusion_criteria": ": \n\n Use of any other investigational drug in another clinical study or a post-marketing clinical study within 120 days before the administration of the study drug \n\n Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment. \n\n Any surgical intervention (including tooth extraction) or trauma within 90 days before hospitalization until the administration, or plan of any surgical intervention within 10 week after the final administration \n\n A deviation from the normal reference range of blood pressure, pulse rate, body temperature, or 12-lead ECG \n\n PT or aPTT on blood coagulation tests outside the upper or lower reference limits (PT: 9.9 to 15.4 sec.; aPTT: 22.5 to 49.5 sec.) \n\n Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before the study \n\n Concurrent or previous hepatic disease (e.g. viral hepatitis, drug-induced liver injury) \n\n Concurrent or previous heart disease (e.g. congestive heart failure, angina pectoris, arrhythmia requiring treatment) \n\n Concurrent or previous respiratory disease (e.g. serious bronchial asthma, chronic bronchitis; except for a history of childhood asthma) \n\n Concurrent or previous renal disease (e.g. acute renal failure, glomerulonephritis, interstitial nephritis; except for a history of calculus) \n\n Concurrent or previous malignant tumor \n\n Excessive smoking or drinking habit [measure of excessive: alcohol: average 45 g/day (a 633 mL bottle of beer contains 25 g of alcohol, and 180 mL of Japanese sake contains 22 g of alcohol), smoking: average 20 cigarettes/day] \n\n Previous treatment with YM150", - "brief_summary": "The purpose of this study is to evaluate the safety and plasma concentration change of YM150 after repeated administration to healthy elderly male and female subjects.", - "NCTID": "NCT01514825" - }, - { - "brief_title": "Evaluating Mechanisms of Blood Pressure Reduction Using Meditation in Hypertensive African Americans", - "phase": "", - "drugs": "['Enhanced health education', 'Transcendental Meditation program']", - "drugs_list": [ - "Enhanced health education", - "Transcendental Meditation program" - ], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "152.0", - "inclusion_criteria": "inclusion criteria: \n\n Self-identifies as African American \n\n Resides in Washington, DC or surrounding communities \n\n Has stage I hypertension, defined as systolic blood pressure between 140 and 159 mm Hg and/or diastolic blood pressure between 90 and 99 mm Hg, on average, without taking antihypertensive medications in the sympatholytic class (e.g., beta blockers, alpha antagonists, central nervous system agonists) \n\n ", - "exclusion_criteria": ": \n\n Blood pressure levels of less than 140/90 mm Hg or greater than 160/100 mm Hg \n\n History of clinical cardiovascular disease (e.g., heart attack, angina, intermittent claudication, congestive heart failure, stroke) \n\n Long-term kidney failure \n\n Any other life-threatening illness (e.g., advanced cancer) \n\n History of major psychiatric disorder (e.g., psychosis, dementia, substance abuse disorder)", - "brief_summary": "High blood pressure is a common health problem among people in the United States. This study will compare the effectiveness of a meditation program versus a health education program at decreasing stress and lowering blood pressure levels among African-American adults with high blood pressure.", - "NCTID": "NCT00681200" - }, - { - "brief_title": "Effects of Amlodipine/Benazepril in the Hypertensive African-American Population With Type 2 Diabetes Mellitus", - "phase": "Phase 4", - "drugs": "['Amlodipine/benazepril']", - "drugs_list": [ - "Amlodipine/benazepril" - ], - "diseases": "['Hypertension']", - "diseases_list": [ - "Hypertension" - ], - "enrollment": "275.0", - "inclusion_criteria": "inclusion criteria: \n\n African-American \n\n males and females \n\n current diagnosis of type 2 diabetes documented by medical history; \n\n mean sitting diastolic blood pressure of \u2265 90 and \u2264 110 mm Hg; \n\n HbA1C \u2264 9.5% \n\n ", - "exclusion_criteria": ": \n\n having unilateral or bilateral renal artery stenosis; \n\n having clinically significant cardiac dysrhythmias; \n\n having a significant history of coronary artery disease within the past 6 months; \n\n having a history or diagnosis of congestive heart failure (CHF); \n\n having any clinically relevant cardiac valvular disease", - "brief_summary": "This study evaluated the efficacy and safety of amlodipine/benazepril compared with that of enalapril in the treatment of hypertension in African-American patients with type 2 diabetes.", - "NCTID": "NCT00367978" - }, - { - "brief_title": "AutoSet for Her Clinical Trial Protocol", - "phase": "", - "drugs": "['Standard AutoSet algorithm', 'Modified AutoSet algorithm']", - "drugs_list": [ - "Standard AutoSet algorithm", - "Modified AutoSet algorithm" - ], - "diseases": "['Obstructive Sleep Apnea']", - "diseases_list": [ - "Obstructive Sleep Apnea" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n Pre-menopausal females aged \u2265 18 years \n\n Current positive airway pressure (PAP)(CPAP or APAP) therapy user with 'current' defined as on PAP therapy for at least 1 month prior to study entry \n\n Diagnostic PSG available \n\n Diagnosis of mild-moderate OSA (AHI \u2264 30) \n\n Participants willing and able to give written informed consent \n\n ", - "exclusion_criteria": ": \n\n Participants currently using Bi-level PAP \n\n Participants currently using supplemental oxygen \n\n Participants who are pregnant \n\n Subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury) \n\n Participants who the researcher believes are unsuitable for inclusion because either: \n\n they do not comprehend English \n\n they are unable to provide written informed consent \n\n they are physically unable to comply with the protocol", - "brief_summary": "The purpose of this study is to assess the efficacy and user preference of the Newport AutoSet for Her in female obstructive sleep apnea (OSA) patients.~Efficacy will be evaluated by comparing the apnea and hypopnea index (AHI) and oxygen desaturation index (ODI) of the Newport AutoSet for Her algorithm to a standard algorithm.~User preference will be evaluated by subjective feedback relating to comfort, ease of falling asleep, sleep disturbance and feeling of being refreshed.", - "NCTID": "NCT01826513" - }, - { - "brief_title": "Effectiveness of SisterTalk Hartford for Weight Loss Among African-American Women", - "phase": "", - "drugs": "['SisterTalk Hartford', 'Attention control video series']", - "drugs_list": [ - "SisterTalk Hartford", - "Attention control video series" - ], - "diseases": "['Overweight', 'Obesity']", - "diseases_list": [ - "Overweight", - "Obesity" - ], - "enrollment": "322.0", - "inclusion_criteria": "inclusion criteria: \n\n BMI of at least 25.0 \n\n self-identifies as Black or African-American \n\n able to do mild physical activity such as walking or chair exercises \n\n ", - "exclusion_criteria": ": \n\n has insulin dependent diabetes \n\n is pregnant, nursing, or had a baby in the past 4 months \n\n has ever been treated for an eating disorder (e.g. anorexia nervosa, bulimia) \n\n had a heart attack in the past 2 years requiring hospitalization \n\n has ever had a stroke \n\n has congestive heart failure \n\n has uncontrolled hypertension \n\n currently participating in another study \n\n is on a doctor-prescribed diet that cannot be changed (e.g. very low protein diet for a person in liver failure)", - "brief_summary": "The purpose of the SisterTalk Hartford study was to assess whether a theoretically- and scientifically-based, culturally acceptable weight loss program could be effectively translated into a faith-based program and subsequently delivered in the church to help African-American women lose weight.", - "NCTID": "NCT01282749" - }, - { - "brief_title": "Study to Investigate Sleep Apnea Patients at Altitude", - "phase": "", - "drugs": "['altitude exposure']", - "drugs_list": [ - "altitude exposure" - ], - "diseases": "['Obstructive Sleep Apnea Syndrome']", - "diseases_list": [ - "Obstructive Sleep Apnea Syndrome" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Obstructive sleep apnea syndrome based on symptoms and a sleep study \n\n ", - "exclusion_criteria": ": \n\n Sleep disorders other than obstructive sleep apnea syndrome \n\n Other than mild, stable cardiovascular disease \n\n Other than mild lung disease \n\n Chronic rhinitis, previous uvulopalatopharyngoplasty \n\n Treatment with drugs that affect respiratory center drive \n\n Internal, neurologic or psychiatric disease that interferes with sleep quality \n\n Previous intolerance to moderate or low altitude < 2600m", - "brief_summary": "The purpose of the study is to investigate the effect of an altitude sojourn on patients with the obstructive sleep apnea syndrome", - "NCTID": "NCT00514826" - }, - { - "brief_title": "Continuous Transcutaneous Electrical Stimulation in Sleep Apnoea", - "phase": "", - "drugs": "['Transcutaneous electrical stimulation', 'Sham stimulation']", - "drugs_list": [ - "Transcutaneous electrical stimulation", - "Sham stimulation" - ], - "diseases": "['Obstructive Sleep Apnoea']", - "diseases_list": [ - "Obstructive Sleep Apnoea" - ], - "enrollment": "44.0", - "inclusion_criteria": "inclusion criteria: \n\n males and females, age >18years and <75years, body-mass index (BMI) >18 and <40kg/m2, non-smokers, sleep apnoea with an ODI \u226515/h or sleep apnoea with an ODI \u22655/h plus an Epworth sleepiness score >10. \n\n ", - "exclusion_criteria": ": \n\n morbid obesity (BMI>40kg/m2) or cachexia (BMI<18kg/m2), obesity-hypoventilation syndrome (total sleep time with oxygen saturation (SpO2) less than 90% of more than 10% of the night), active smokers or smoking history of >20pack years, acute or critical illness, acute psychosis or chronic mental disorder affecting capacity, previous home-mechanical non-invasive ventilation and metal implants in the upper part of the body (this excludes dental implants).", - "brief_summary": "The aim of this randomized, double-blinded, sham-controlled cross-over trial is to demonstrate the effectiveness of continuous transcutaneous electrical stimulation of the pharyngeal dilator muscles to reduce sleep-disordered breathing.", - "NCTID": "NCT01661712" - }, - { - "brief_title": "The Role of Angiotensin Type I Receptor in the Regulation of Human Peripheral Vascular Function", - "phase": "Phase 3", - "drugs": "['Angiotensin II type 1 receptor antagonists']", - "drugs_list": [ - "Angiotensin II type 1 receptor antagonists" - ], - "diseases": "['Atherosclerosis', 'Heart Failure, Congestive', 'Hypertension', 'Myocardial Infarction']", - "diseases_list": [ - "Atherosclerosis", - "Heart Failure", - "Congestive", - "Hypertension", - "Myocardial Infarction" - ], - "enrollment": "36.0", - "inclusion_criteria": "Patients over 18 years with endothelial dysfunction requiring diagnostic cardiac catheterization. \n\n Normal volunteers or patients undergoing catheterization who have normal coronary arteries without risk factors for atherosclerosis will be used as controls. \n\n No unstable angina. \n\n No significant left main disease (greater than 50% stenosis). \n\n No recent myocardial infarction (less than 1 month). \n\n No pregnancy, lactation. \n\n No allergy to losartan. \n\n No renal failure (creatinine greater than 2.5 mg/dl). \n\n Ability to withdraw ACE inhibitors.", - "exclusion_criteria": "", - "brief_summary": "The renin angiotensin system (RAS) plays an important physiological and pathophysiological role in the control of blood pressure and plasma volume. Inhibition of the RAS is useful in the treatment of hypertension, cardiac failure and in some patients with myocardial infarction. Several recent clinical trials with angiotensin converting enzyme inhibitors (ACEI) have shown that they also reduce the incidence of myocardial infarction, but the mechanisms underlying this anti-ischemic effect are poorly understood. ACEI reduce angiotensin II synthesis and prevent bradykinin degradation. Results from ongoing studies in the Cardiology Branch (Protocol 95-H-0099) designed to investigate the link between ACEI and the vascular endothelium indicate that ACEI improve peripheral endothelial function, an effect that is partially mediated by bradykinin. The current protocol is designed to investigate whether the beneficial effects of ACEI on peripheral endothelial function are also due to inhibition of angiotensin II. The recent development of selective angiotensin II type 1 (AT1) receptor antagonists allows us to specifically examine the effects of angiotensin II on vasomotor activity.", - "NCTID": "NCT00001628" - }, - { - "brief_title": "Angiotensin II Receptor Blockers (ARB) and ACE Inhibitors (ACEI) on Silent Brain Infarction and Cognitive Decline", - "phase": "Phase 4", - "drugs": "['Angiotensin II Receptor Antagonists', 'Angiotensin-converting Enzyme Inhibitors']", - "drugs_list": [ - "Angiotensin II Receptor Antagonists", - "Angiotensin-converting Enzyme Inhibitors" - ], - "diseases": "['Brain Infarction', 'Hypertension']", - "diseases_list": [ - "Brain Infarction", - "Hypertension" - ], - "enrollment": "395.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with essential hypertension (systolic blood pressure>=140 mmHg and/or diastolic blood pressure>=90, or treated with antihypertensive drugs) \n\n Patients with any finding of stroke, silent brain infarction, and white matter lesion on magnetic resonance imaging \n\n ", - "exclusion_criteria": ": \n\n Secondary hypertension \n\n Atrial fibrillation \n\n History or signs of cerebral disorders other than cerebrovascular disease \n\n Malignant tumor \n\n Chronic renal failure \n\n Severe congestive heart failure \n\n Hyperkalemia \n\n Stenosis of bilateral renal artery", - "brief_summary": "The purpose of this study is to elucidate whether or not angiotensin II receptor blockers (ARB) are more beneficial or equal to angiotensin converting enzyme inhibitors (ACEI) on development or progression of silent brain infarction and cognitive decline in Japanese patients with essential hypertension in the elderly.", - "NCTID": "NCT00126516" - }, - { - "brief_title": "STOPBANG As A Screening Tool for Obstructive Sleep Apnoea in Pregnancy", - "phase": "", - "drugs": "['STOPBANG Questionnaire', 'Overnight pulse oximetry', 'Epworth Sleepiness Scale']", - "drugs_list": [ - "STOPBANG Questionnaire", - "Overnight pulse oximetry", - "Epworth Sleepiness Scale" - ], - "diseases": "['Obstructive Sleep Apnoea', 'Pregnancy']", - "diseases_list": [ - "Obstructive Sleep Apnoea", - "Pregnancy" - ], - "enrollment": "117.0", - "inclusion_criteria": "inclusion criteria: \n\n Pregnant women \n\n Body mass index \u2265 40 at first midwife appointment \n\n Women \u2265 18 years of age \n\n ", - "exclusion_criteria": ": \n\n Pre-existing obstructive sleep apnoea on treatment \n\n Pre-existing restrictive or obstructive respiratory disease \n\n Women with another cause of sleep apnoea (e.g. central sleep apnoea) \n\n Women under 18 years of age \n\n Women who do not provide or refuse consent \n\n Women lacking capacity to consent", - "brief_summary": "This study evaluates the use of the STOPBANG questionnaire to predict whether a pregnant woman with class III obesity has obstructive sleep apnoea. All participants will have a STOPBANG score and modified STOPBANG score (substituting Epworth score > 10 with the tired item) calculated and then be tested with overnight pulse oximetry to see if they meet ODI criteria for obstructive sleep apnoea.", - "NCTID": "NCT02542488" - } - ], - "1": [ - { - "brief_title": "Flu Vaccination in Congestive Heart Failure", - "phase": "Phase 4", - "drugs": "['Flu Vaccine', 'Conventional medical therapy for heart failure']", - "drugs_list": [ - "Flu Vaccine", - "Conventional medical therapy for heart failure" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "117.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female patient's > 21 years of age with a severe congestive heart failure (New York Heart Association class III or IV) requiring an immediate administration of intravenous vasodilators drugs, oxygen therapy, and no less than 160 mg of intravenous furosemide were eligible for inclusion. \n\n Definite evidence of underlying heart failure was also required as shown by at least two of the following: \n\n a) Orthopnea on admission \n\n b) X-ray showing evidences of elevated wedge pressure indicating congestive heart failure \n\n c) recent prior hospitalization (within the 30 days prior to the index hospitalization) because a congestive heart failure episode \n\n d) echocardiography data showing a poor left ventricular ejection fraction (0.40 or lower measuring with the biplane Simpson's method \n\n e) non-invasive ventilation to the maintenance of SaO2 above 90% \n\n f) wet rales in at least the lower half of the lungs fields \n\n Patients with a final diagnosis of Congestive Heart Failure as a consequence of necrotic or chronic ischemic heart disease, or infective origin such as chronic Chagas Disease, chronic valvular heart disease (surgically repaired or not), and idiopathic origin were also included for the present study \n\n ", - "exclusion_criteria": ": \n\n Patients with a concomitant infective disease were excluded from the study \n\n Patients with evidence of evolving with multi organic failure (hepatic or renal dysfunction requiring dialysis), terminal disease, or any impeding cause of follow-up, including contraindications of vaccination, were excluded from the study \n\n Those with congestive heart failure following unstable coronary artery disease, or prior by-pass surgery, or angioplasty or congestive heart failure complicating myocardial infarction requiring urgent intervention were excluded also \n\n Those individuals who required mechanical ventilation on admission \n\n Patients with prior vaccinations were also excluded \n\n Pregnancy condition was an exclusion criterion \n\n Those patients who were unable or refused to give a written inform consent was also excluded of the present study", - "brief_summary": "We evaluated the preventive impact of vaccination on subsequent death events in 117 severe congestive heart patients requiring ventilator support without endotracheal intubations and aggressive medical therapy.~They were randomly allocated in a single-blind manner as a unique intramuscular influenza vaccination or as controls.~The first primary outcome evaluated at 6 months follow-up - cardiovascular death - occurred in 3% of the patients in the vaccine group Vs 17% in controls (p=0.022). The composite end point occurred in 33% of the patients in the vaccine group Vs 74% in control group, p = <0.001.", - "NCTID": "NCT00664339" - }, - { - "brief_title": "SUrvey of Guideline Adherence for Treatment of Systolic Heart Failure in Real World", - "phase": "", - "drugs": "['guideline adherence']", - "drugs_list": [ - "guideline adherence" - ], - "diseases": "['Heart Failure, Congestive']", - "diseases_list": [ - "Heart Failure", - "Congestive" - ], - "enrollment": "1.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects admitted to hospital with systolic heart failure(LVEF under 45%) in 2009 \n\n Subjects, age 20 or/and above \n\n Subjects admitted to hospital (emergency area, to internal medicine or to cardiology wards, CCU or intensive care) with dyspnea and verification of heart failure based on following criteria; \n\n Symptoms typical of heart failure : breathlessness at rest or on exercise, fatigue, tiredness, ankle swelling and Signs typical of heart failure : tachycardia, tachypnoea, pulmonary rales, pleural effusion, raised jugular venous pressure, peripheral oedema, hepatomegaly \n\n Objective evidence of a structural or functional abnormality of the heart at rest : cardiomegaly, third heard sound, cardiac murmurs, abnormality on the echocardiogram, raised natriuretic peptide concentration \n\n ", - "exclusion_criteria": ": \n\n Subject who expired during hospitalization", - "brief_summary": "The purpose of this study is to survey the guideline compliance of the cardiologists in the treatment of systolic heart failure in Korea", - "NCTID": "NCT01390935" - }, - { - "brief_title": "Aldosterone Blockade in Heart Failure", - "phase": "Phase 3", - "drugs": "['Spironolactone', 'Placebo']", - "drugs_list": [ - "Spironolactone", - "Placebo" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "8.0", - "inclusion_criteria": "inclusion criteria: \n\n HF by Framingham criteria \n\n At least one admission to hospital for HF within the last 180 days \n\n New York Heart Association Class II thru IV \n\n Echocardiographic criteria:At least moderate diastolic dysfunction, Ejection fraction >45% \n\n ", - "exclusion_criteria": ": \n\n Creatinine clearance <40 mls/min/1.73m2 \n\n Potassium >5.0 mmol/L \n\n Recent acute coronary syndrome in the prior 4 weeks \n\n Planned revascularization, defibrillator or pacemaker in next 4 months \n\n Known previous intolerance to aldosterone antagonist", - "brief_summary": "Heart failure causes significant morbidity and mortality and is the most rapidly increasing cardiovascular diagnosis in North America overall prevalence is estimated at 0.4% to 2.4%. Recently, heart failure with a preserved ejection fraction (HFNEF) was found in up to 50% of patients with symptomatic heart failure. Many studies have demonstrated that HFNEF has a poor prognosis with a mortality rate of up to 8% per year and a 50% chance of needing to be admitted to hospital in the next year. There are no proven therapies for this type of heart failure.~Aldosterone blockers (these drugs block a hormone that is elevated in patients with heart failure) are used in other types of heart failure. Our goal is to see if this type of drug improves the function of the heart by looking at the thickness of the heart muscle using MRI. Also we will measure the amount of tissue formation and breakdown in the heart. The trial will be done using both the drug and a placebo so that we can see what effects are due to the drug.", - "NCTID": "NCT00523757" - }, - { - "brief_title": "Pain Assessment, Incidence & Nature in Heart Failure", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Heart Diseases']", - "diseases_list": [ - "Heart Diseases" - ], - "enrollment": "349.0", - "inclusion_criteria": "inclusion criteria: \n\n Advanced HF (Stage D or advanced Stage C HF) with: \n\n symptoms of dyspnea at rest or with minimal exertion systolic dysfunction or preserved systolic function (diastolic heart failure) Outpatient care setting (office, clinic or home hospice). \n\n Patient already receiving optimal medical therapy per ACC/AHA guidelines (ACEI or ARB + \u03b2-blocker +aldosterone antagonist) for at least 1 month or explanation of intolerance of specific medication. We will exclude those not on optimized medications with no notation of intolerance; however, we will keep a tally to quantify patients who are considered advanced Heart Failure but are not on recommended medications. \n\n Can be awaiting LVAD, transplantation or other procedure \n\n Age > 18 years and able to sign informed consent to participate \n\n ", - "exclusion_criteria": ": \n\n Cognitive or other impairment which prevents accurate assessment of symptoms or ability to provide informed consent. \n\n Heart failure due to recent onset of acute viral myocarditis, peripartum myocarditis. \n\n Patient on hemodialysis or receiving mechanical ventilation \n\n Patients receiving investigational agents or devices. \n\n Patients who have received heart transplant or a destination Left Ventricular Assist Device", - "brief_summary": "Heart failure, a chronic illness afflicting 5 million persons in the United States is known to cause shortness of breath and fatigue, yet at least half of persons with heart failure also report the presence of pain.~The cause of pain for these persons is not clear. PAIN-HF (Pain Assessment, Incidence & Nature in Heart Failure), conducted through the Palliative Care-Heart Failure Education And Research Trials (PC-HEART) collaborative will identify the prevalence of pain, its location, severity and impact on activities and the possible causes of pain in persons living with heart failure. The study will also try to understand relationships between other problems and pain, as well as what treatments are given to reduce pain.~Understanding sources of pain and its characteristics is the first step in helping health care providers better manage pain and related problems in persons with heart failure.", - "NCTID": "NCT00444301" - }, - { - "brief_title": "High-Dose Aldactone for Treatment of Diuretic Resistant Heart Failure", - "phase": "Phase 4", - "drugs": "['Spironolactone']", - "drugs_list": [ - "Spironolactone" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years or older patients with congestive heart failure \n\n Hypervolemic by at least 2 of the following criteria: 1) Peripheral edema; 2) jugular venous distention greater than 7 cm; 3) radiographic pulmonary edema or pleural effusion; 4) enlarged liver or ascites; 5) pulmonary rales, paroxysmal nocturnal dyspnea or orthopnea \n\n Diuretic resistance as defined by loop diuretic requirements of furosemide greater or equal to 160 mg IV total daily dose or equivalent dose of torsemide or bumetanide. ( 1 mg bumetanide = 10 mg torsemide = 20 mg furosemide) \n\n Estimated glomerular filtration rate (eGFR) of > 30ml/min. according to the MDRD Study equation at the time of admission. \n\n Female patients of child bearing potential must have a negative urine pregnancy test to be eligible. \n\n ", - "exclusion_criteria": ": \n\n Acute coronary syndrome \n\n Patients with a baseline eGFR < 30 ml/min according to the MDRD equation. \n\n Baseline potassium serum concentration 5.3 meq/L \n\n Requirement for intravenous pressors \n\n Systemic infection \n\n Patients with concomitant end-stage liver disease \n\n Significant valvular disease \n\n Patients with pulmonary embolism \n\n Patients with high output heart failure \n\n Pregnant patients", - "brief_summary": "Prospective, open-label, randomized cohort study comparing adding high-dose spironolactone to usual heart failure care versus usual care in patients with acute decompensated heart failure. Patients will be randomized in a 1:1 fashion to either usual care or high-dose spironolactone plus usual care. Both arms of the study will continue with treatment of ADHF until euvolemia as defined as the resolution of pulmonary edema, peripheral edema, abdominal bloating and/or jugular venous distention. Assessment of clinical status and serum electrolytes, symptoms and renal function will be performed in accordance to standard of care.", - "NCTID": "NCT02429388" - }, - { - "brief_title": "The Congestive Heart Failure Adherence Redesign Trial", - "phase": "Phase 3", - "drugs": "['Enhanced Training', 'Enhanced Education']", - "drugs_list": [ - "Enhanced Training", - "Enhanced Education" - ], - "diseases": "['Heart Failure, Congestive', 'Cardiovascular Diseases', 'Heart Diseases']", - "diseases_list": [ - "Heart Failure", - "Congestive", - "Cardiovascular Diseases", - "Heart Diseases" - ], - "enrollment": "320.0", - "inclusion_criteria": "inclusion criteria: \n\n inclusion criteria (PCP) 1. Provider must be the health professional who is managing the potential patient enrollee's heart failure medication(s). \n\n inclusion criteria (Patients) \n\n Participant has been diagnosed with Heart Failure (HF), \n\n Self reported family income is less than $30,000/year, \n\n Has experienced at least one hospitalization for acute, decompensated, HF within the previous 6 months based upon: \n\n Being admitted for symptoms of HF (ex: peripheral edema, shortness of breath and fatigue), and \n\n responding to anti-failure therapy such as diuretics and other anti-failure therapy such as ACE Inhibitors, ARBs, or Beta blockers. \n\n Has evidence of systolic dysfunction, defined by an ejection <50 by 1 of 3 methods: echocardiography, radiographic contrast ventriculography, or nuclear ventriculography; done within the last year. \n\n Age \u2265 18 years \n\n Currently resides in Cook County, Illinois. \n\n Speaks English or Spanish. \n\n The primary care provider (PCP) has consented and has no more than 12 patients enrolled. \n\n Completed the informed consent process. \n\n Successfully completed the 30-day run-in period and study baseline visit \n\n ", - "exclusion_criteria": ": \n\n ", - "brief_summary": "The purpose of this study is to test whether a culturally sensitive self-management (SM) intervention, compared to an education only control, will reduce all-cause hospital days in patients with mild to moderate heart failure and household income less than $30,000 per year.", - "NCTID": "NCT01698242" - }, - { - "brief_title": "Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial", - "phase": "", - "drugs": "['Ultrafiltration therapy']", - "drugs_list": [ - "Ultrafiltration therapy" - ], - "diseases": "['Congestive Heart Failure']", - "diseases_list": [ - "Congestive Heart Failure" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients will be recruited from the cardiology clinic at Hennepin County Medical Center. Patients are eligible for the study if they are: \n\n Older than 18 \n\n Not pregnant \n\n Have heart failure with worsening hypervolemia despite oral diuretics \n\n Have at least two of the following signs or symptoms of hypervolemia: JVD, edema >1+, rales pulmonary edema on chest x-ray, orthopnea or PND \n\n Not more than 10 kg above their usual baseline weight \n\n Have, in the opinion of the treating physician, a need for a minimum of 2 liters of volume removal \n\n ", - "exclusion_criteria": ": \n\n Systolic blood pressure < 90 mmHg \n\n Serum creatinine > 3.0 mg/dL \n\n Hematocrit >45 % \n\n Uncontrolled arrhythmias \n\n Need for hospitalization \n\n Require renal replacement therapy \n\n Contraindication to anticoagulation with heparin \n\n Poor venous access. \n\n -", - "brief_summary": "This trial will look at the effectiveness and patient acceptance of ultrafiltration therapy in an outpatient setting.~The purpose of this study is to determine if ambulatory patients who suffer from heart failure and hypervolemia can be safely and effectively treated in an outpatient infusion clinic. The results from this trial will be useful in planning a larger, randomized trial comparing usual care and ultrafiltration for this patient population in similar ambulatory settings.", - "NCTID": "NCT00319384" - }, - { - "brief_title": "Diuretic Efficacy of Dexamethasone in Heart Failure", - "phase": "Phase 1", - "drugs": "['dexamethasone']", - "drugs_list": [ - "dexamethasone" - ], - "diseases": "['Heart Failure, Congestive']", - "diseases_list": [ - "Heart Failure", - "Congestive" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Congestive heart failure patients due to any cause \n\n Patients with normal cortical function \n\n Congestive heart failure patients who are on diuretic therapy \n\n Clinically stable and body weight maintained the same for at least 3 days without signs of fluid retention \n\n ", - "exclusion_criteria": ": \n\n Patient refusal \n\n Signs of infection", - "brief_summary": "The purpose of this study is to determine whether glucocorticoids have potent diuretic effects in patients with congestive heart failure.", - "NCTID": "NCT00263302" - }, - { - "brief_title": "Short Term Hemodynamic Effects of Controlled Slow Breathing With Biofeedback in Patients With Heart Failure", - "phase": "", - "drugs": "['Slow breathing']", - "drugs_list": [ - "Slow breathing" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "11.0", - "inclusion_criteria": "inclusion criteria: NORMAL SUBJECTS \n\n Normal subject without history, signs-symptoms or diagnosis of heart failure \n\n Age over 18 and willing and able to provide informed consent. \n\n ", - "exclusion_criteria": ": NORMAL SUBJECTS \n\n Known allergy to electrode gel and medical adhesive used on electrocardiographic electrodes. \n\n Pregnancy (as any effect of this device use on pregnancy is not known). \n\n Patient belonging to a vulnerable population such as institutionalized persons, prisoners and persons with decisional incapacity or dementia. \n\n Presence of severe aortic regurgitation. \n\n Second degree Mobitz type II or third degree heart block, unless treated with a cardiac pacemaker. \n\n Implantation of a left ventricular assists device, hemodynamic monitor, activated minute ventilation pacemaker, or biventricular pacemaker (Cardiac Resynchronization Therapy) with the V-to-V interval set at more than 5 milliseconds offset. \n\n Implantation of a cardiac resynchronization device within the last 30 days. \n\n inclusion criteria: CHRONIC AMBULATORY HEART FAILURE \n\n Patients over the age of 18 and able to give consent \n\n Ability to understand and willing to sign informed consent \n\n Diagnosis of Chronic Heart Failure and currently on optimal medical therapy \n\n ", - "brief_summary": "Heart failure is associated with faster breathing, which has a negative impact on the functioning of the heart. This leads to fatigue, shortness of breath, and exercise intolerance. It has been shown that when slow breathing technique was taught to patients with heart failure, they had a reduction in their sensation of shortness of breath and an improvement in their exercise performance.~The study will compare the short-term effects of controlled slow breathing with biofeedback in normal healthy subjects, acute heart failure, and chronic stable heart failure. The purpose is to see if there is any change in the objective measurements of heart function while breathing at normal rates compared to a controlled slower rate.", - "NCTID": "NCT00971386" - }, - { - "brief_title": "Water Immersion in Right-Sided Heart Failure: A Pilot Study", - "phase": "Phase 4", - "drugs": "['Water immersion']", - "drugs_list": [ - "Water immersion" - ], - "diseases": "['Right Sided Cardiac Failure']", - "diseases_list": [ - "Right Sided Cardiac Failure" - ], - "enrollment": "13.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients must have right sided failure secondary to right ventricular dysfunction, pulmonary hypertension, or tricuspid regurgitation \n\n Age greater than 18 years of age \n\n Right heart catheterization within the last year to rule out left-sided failure. \n\n Evidence of fluid overload as indicated by 2 or more of the following: 1.) 2+ or more pitting edema of the lower extremities, 2.) scrotal or penile edema, 3.) JVP greater than or equal to 10 cm, 4.) abdominal ascites \n\n ", - "exclusion_criteria": ": \n\n Pulmonary capillary wedge pressure above 16 mmHg or history of elevated left ventricular filling pressures. \n\n Serum creatinine > 2.0 \n\n Current use of an angiotensin I converting enzyme inhibitor or angiotensin receptor blocker will preclude participation in the RAS neurohormone portion of the study.", - "brief_summary": "This is an unblinded pilot study comparing (against a randomized control day without water immersion) the diuretic and natriuretic effects of water immersion in patients with right heart failure.", - "NCTID": "NCT00654264" - }, - { - "brief_title": "Bi Treatment With Hydralazine/Nitrates Versus Placebo in Africans Admitted With Acute Heart Failure", - "phase": "Phase 3", - "drugs": "['Hydralazine', 'Isosorbide Dinitrate']", - "drugs_list": [ - "Hydralazine", - "Isosorbide Dinitrate" - ], - "diseases": "['Acute Heart Failure', 'Left Ventricular Dysfunction']", - "diseases_list": [ - "Acute Heart Failure", - "Left Ventricular Dysfunction" - ], - "enrollment": "500.0", - "inclusion_criteria": "inclusion criteria: \n\n > 18 years of age \n\n Hospital admission for acute heart failure as defined by the presence of acute dyspnea and the presence of clinical signs of heart failure on physical examination. \n\n Where available, NT-proBNP >900 pg/ml, >1800 pg/ml if the patient has atrial fibrillation at screening or >450 pg/ml if BMI > 35 kg/m2, LVEF <45% assessed by echocardiography or other method within the previous 12 months \n\n Background therapy with at least ACE-inhibitor or angiotensin receptor blocker (ARB) and beta-blocker (unless beta-blocker is contraindicated due to severe volume overload, low output heart failure, or cardiogenic shock) \n\n Available for regular follow up \n\n ", - "exclusion_criteria": ": \n\n Currently being treated with Hydralazine and/or nitrates or a history of intolerance to oral therapy with either hydralazine or nitrates. \n\n . Any intravenous treatment for heart failure, except IV furosemide (eg. IV inotropes, pressors, nitrates or nesiritide) at the time of screening. \n\n Systolic blood pressure <100 mmHg \n\n Plan for revascularization \n\n Greater than 96 hours after admission \n\n Reversible etiology of acute heart failure such as myocarditis, acute myocardial infarction, arrhythmia. Acute MI is defined as symptoms and major electrocardiogram (ECG) changes(i.e., ST segment elevations), and arrhythmia includes unstable heart rates above 120/min or below 50/min. \n\n Hypertrophic obstructive cardiomyopathy, constrictive cardiomyopathy, endomyocardial fibroelastosis \n\n Known severe congenital heart disease (such as uncorrected tetralogy of fallot or transposition of the aorta) \n\n Severe aortic or mitral stenosis or severe rheumatic mitral regurgitation. \n\n Renal impairment (defined by creatinine >3 mg/dL) at screening or on any type of dialysis. \n\n Known hepatic impairment (total bilirubin >3mg/dl) or increased ammonia levels at screening. \n\n History of systemic lupus erythematous. \n\n Stroke or TIA within 2 weeks from screening. \n\n Women who are pregnant or lactating. \n\n Allergy to organic nitrates. \n\n History or presence of any other diseases (ie. Including malignancies or AIDS) with a life expectancy of < 12 months", - "brief_summary": "To investigate the effect of hydralazine isosorbide dinitrate on clinical outcomes, symptoms, cardiac parameters and functional status of African patients hospitalized with AHF and left ventricular dysfunction during 24 weeks of therapy.~Administration of hydralazine/nitrates will be superior to placebo administration in reducing HF readmission or death, improving dyspnoea, reducing blood pressure and brain natriuretic peptide (BNP) in African patients admitted with AHF and left ventricular dysfunction.", - "NCTID": "NCT01822808" - }, - { - "brief_title": "Atrial Fibrillation and Congestive Heart Failure Trial", - "phase": "Phase 4", - "drugs": "['Rate vs rhythm control strategies for atrial fibrillation', 'Rate vs rhythm control strategies in atrial fibrillation']", - "drugs_list": [ - "Rate vs rhythm control strategies for atrial fibrillation", - "Rate vs rhythm control strategies in atrial fibrillation" - ], - "diseases": "['Atrial Fibrillation', 'Congestive Heart Failure']", - "diseases_list": [ - "Atrial Fibrillation", - "Congestive Heart Failure" - ], - "enrollment": "1376.0", - "inclusion_criteria": "inclusion criteria: \n\n Left ventricular ejection fraction /=6 hours (duration of AF will be determined by history), within the past 6 months with electrocardiographic confirmation; or \n\n an episode lasting >/=10 minutes (by history) within the past 6 months with electrocardiographic confirmation in a patient with a prior electrical cardioversion for AF. \n\n In the opinion of the clinical investigator, the patient must be eligible for long-term treatment with either treatment strategy of AF. \n\n ", - "exclusion_criteria": ": \n\n AF is known to be present and uninterrupted for more than 12 months prior to randomization. However, if such a patient is cardioverted and maintained in sinus rhythm for >/=24 hours, he or she becomes eligible. \n\n Reversible cause of AF such as acute pericarditis, pulmonary embolism, hyperthyroidism, alcohol intoxication. \n\n AF occurring and not persisting beyond 10 days of surgery or myocardial infarction. \n\n Reversible cause of CHF such as severe aortic or mitral stenosis and tachycardia-induced cardiomyopathy. \n\n Decompensated CHF within 48 hours of randomization. \n\n Antiarrhythmic drugs other than calcium channel blockers, beta-blockers or digoxin required for other arrhythmias or other indications. \n\n More than 7 days of amiodarone therapy within the last month prior to randomization. \n\n Second or third degree AV block, sinus pause >3 seconds, resting heart rate <50 bpm without a permanent pacemaker. \n\n History of drug-induced Torsades de Pointes or congenital long QT syndrome. \n\n Prior AV nodal ablation or Maze surgery. \n\n Probable cardiac transplantation in the next 6 months. \n\n Chronic renal failure requiring dialysis. \n\n Women of child-bearing potential and not on a reliable method of birth control. \n\n Geographic or social factors, drug or alcohol abuse making follow-up or compliance difficult. \n\n Other noncardiovascular medical condition (such as cancer) making 1 year survival unlikely. \n\n Less than 18 years of age.", - "brief_summary": "Heart failure is a clinical syndrome where the heart is unable to pump enough blood to satisfy the organism's metabolic needs. Heart failure has become a major clinical and public health problem with approximately 300,000 Canadians being affected. Atrial fibrillation is a rhythm disorder in which the upper chambers of the heart (the atria) are paralyzed by continuous electrical activity. Some of the continuous chaotic electrical activity in the atria travels to the lower cavities of the heart (the ventricles) causing then to beat irregularly and very rapidly. It is the most frequent cardiac arrhythmia, affecting 5% of individuals 65 years and older and it is associated with an increased risk of stroke. Both conditions (heart failure and atrial fibrillation) often co-exist in the same patient. Heart failure promotes atrial fibrillation and atrial fibrillation aggravates heart failure. The Atrial Fibrillation and Congestive Heart Failure (AF-CHF) trial is investigating whether preservation of normal cardiac rhythm influences mortality and morbidity. The AF-CHF study began in 2001 and 1,378 patients have been enrolled from 123 participating centres, in North America, South America, Europe, and Israel. The results of this trial which are expected in October 2007, will improve decision-making for the physician and will provide useful information to healthcare organizations responsible for the care of heart failure patients.", - "NCTID": "NCT00597077" - }, - { - "brief_title": "Comparison of Oral or Intravenous Thiazides vs Tolvaptan in Diuretic Resistant Decompensated Heart Failure", - "phase": "Phase 4", - "drugs": "['tolvaptan', 'Chlorothiazide', 'Metolazone']", - "drugs_list": [ - "tolvaptan", - "Chlorothiazide", - "Metolazone" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n age of 18 years or older \n\n hospital admission for hypervolemic decompensated heart failure complicated by loop diuretic resistance \n\n 24 hour telemetry monitoring on an inpatient ward \n\n basic metabolic panel laboratory assessment twice daily during the study period \n\n Hypervolemia will be diagnosed by the admitting provider as either (i) pulmonary artery catheterization with a pulmonary capillary wedge pressure greater than 19mmHg plus a systemic physical exam finding of hypervolemia (peripheral edema, ascites, or pulmonary edema on auscultation) or (ii) in the absence of pulmonary artery catheterization data 2 of the following signs or symptoms: peripheral edema ascites, jugular venous pressure > 10mmHg, or pulmonary edema on chest x-ray. \n\n Loop diuretic resistance is defined as a provider decision to pursue combination diuretic therapy because of failure to reach provider defined adequate diuresis (can not exceed urine output of 2 L in past 12 hours) despite receipt of an intravenous loop diuretic dose of a furosemide equivalent of at least 240mg/day over at least the past 12 hours (40mg furosemide = 20mg torsemide = 1mg bumetanide). \n\n ", - "exclusion_criteria": ": \n\n decision to pursue hemodialysis by a nephrologist \n\n estimated glomerular filtration rate by the MDRD equation < 15ml/min/m2 \n\n systolic blood pressure < 85mmHg \n\n pregnancy \n\n serum potassium < 3.0mEq/L \n\n serum sodium > 145mEq/L or < 130mEq/L \n\n severe malnutrition \n\n advanced liver disease \n\n inability to perform standing weights \n\n inability to collect and measure urine with either a foley catheter or urine collection containers \n\n concomitant therapy with strong CYP3A4 inhibitors/inducers (systemic ketoconazole, clarithromycin, itraconazole, telithromycin, saquinavir, nelfinavir, ritonavir, nefazodone, rifampin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine, St. John's Wort) \n\n concomitant therapy with p-glycoprotein inhibitors (cyclosporine, erythromycin, tacrolimus, dronedarone, quinidine, or verapamil) \n\n non-study diuretics (spironolactone doses >75mg/day, eplerenone > 75mg/day, non-study thiazides or loop diuretics, or systemic acetazolamide, triamterene, or amiloride therapy) \n\n thiazides administration in the previous 24 hours prior to randomization", - "brief_summary": "Broad Objectives: To determine the comparative efficacy of commonly employed strategies to overcome loop diuretic resistance when added to concomitant loop diuretics in hospitalized decompensated heart failure patients with hypervolemia~Specific Aims:~Compare the 48-hour weight change of either intravenous chlorothiazide or oral tolvaptan compared to standard-of-care oral metolazone when combined with standardized loop diuretic dosing for diuretic resistance in decompensated heart failure~Compare the adverse effects of electrolyte depletion and renal function changes between intravenous chlorothiazide or oral tolvaptan compared to standard-of-care oral metolazone when combined with standardized loop diuretic dosing for diuretic resistance in acute heart failure~Pharmacoeconomic analysis of the direct costs of intravenous chlorothiazide or oral tolvaptan compared to standard-of-care oral metolazone when combined with standardized loop diuretic dosing for diuretic resistance in acute heart failure~The investigators will conduct a dual center, randomized, double-blind, double-dummy, parallel design trial comparing: oral metolazone, intravenous chlorothiazide, or oral tolvaptan, in combination with loop diuretics in 60 patients hospitalized for hypervolemic decompensated heart failure and displaying loop diuretic resistance.", - "NCTID": "NCT02606253" - }, - { - "brief_title": "University of Michigan Advanced Heart Failure Tele-Monitoring and Flexible Diuretic Project", - "phase": "", - "drugs": "['Telemonitoring', 'Flexible Diuretic Regimen']", - "drugs_list": [ - "Telemonitoring", - "Flexible Diuretic Regimen" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "51.0", - "inclusion_criteria": "inclusion criteria: \n\n University of Michigan patients hospitalized for the treatment of heart failure, within the past 30 days. \n\n Patients must be receiving an oral loop diuretic on their home regimen or have received intravenous loop diuretic during the index hospitalization at the time of enrollment. \n\n Patients must have an assessment of left ventricular function within the previous 2 years. \n\n Patients must have LVEF \u2264 40%, or LVEF >40 with evidence of left atrial enlargement (LA dimension > 40 mm), BNP > 200 ng/ml or PCW > 18 mmHg. \n\n ", - "exclusion_criteria": ": \n\n Prisoners \n\n Residents of long term nursing facilities \n\n Enrollment into a hospice program \n\n Receiving dialysis \n\n Patients with dementia \n\n Patients with dGFR less than 20ml/min. \n\n Patients being worked up for heart surgery. \n\n Patients being worked up for heart transplant. \n\n Patients being evaluated for revascularization. \n\n Patients being evaluated for heart valve intervention. \n\n Patients with primary pulmonary hypertension.", - "brief_summary": "The proposed project is a 2x2 factorial designed study aimed at assessing the impact of 1) a home tele-monitoring system and 2) a flexible diuretic regimen among high risk heart failure patients in the University of Michigan Health System (UMHS).", - "NCTID": "NCT02344342" - }, - { - "brief_title": "Beta-Blocker Evaluation in Survival Trial (BEST)", - "phase": "Phase 3", - "drugs": "['adrenergic beta antagonists']", - "drugs_list": [ - "adrenergic beta antagonists" - ], - "diseases": "['Cardiovascular Diseases', 'Heart Diseases', 'Heart Failure, Congestive', 'Heart Failure']", - "diseases_list": [ - "Cardiovascular Diseases", - "Heart Diseases", - "Heart Failure", - "Congestive", - "Heart Failure" - ], - "enrollment": "", - "inclusion_criteria": "Men and women, ages 18 and over. Patients had compensated congestive heart failure due to idiopathic dilated cardiomyopathy or coronary disease with ejection fraction less than or equal to 0.35, were in the New York Heart Association functional class III or IV, and were taking an angiotensin-converting enzyme inhibitor, digitalis, and if needed, a diuretic. Patients with a specific indication for, or contraindication to, beta-blockade were excluded.", - "exclusion_criteria": "", - "brief_summary": "To determine if addition of a beta-blocker to standard therapy in Class III and Class IV heart failure patients reduced total mortality.", - "NCTID": "NCT00000560" - }, - { - "brief_title": "A Randomized Study of the MitraClip Device in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation", - "phase": "", - "drugs": "['MitraClip']", - "drugs_list": [ - "MitraClip" - ], - "diseases": "['Cardiovascular Diseases']", - "diseases_list": [ - "Cardiovascular Diseases" - ], - "enrollment": "42.0", - "inclusion_criteria": "inclusion criteria: \n\n Age between 18 years and 90 years old \n\n Clinically significant functional mitral regurgitation (moderate-to-severe or severe mitral regurgitation), as defined by European Association of Echocardiography, within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory \n\n Assessed by the investigator to be on optimal standard of care therapy for heart failure for at least 4 weeks with no dose changes of heart failure drugs (with the exception of diuretics) during the last 2 weeks immediately prior to randomization \n\n Documented New York Heart Association Class III or Class IV heart failure, despite optimal standard of care therapy, within 90 days preceding randomization \n\n Minimum of one documented hospitalization (acute care admission or emergency room visit) for heart failure within 12 months preceding randomization OR values of at least 350 pg/mL for BNP or at least 1400 pg/mL for NT-proBNP after optimal medical and/or device management within 90 days preceding randomization \n\n Left ventricular ejection fraction (LVEF) \u226515% and \u226440% determined by transthoracic echocardiogram within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory \n\n Left ventricular end diastolic diameter (LVEDD) \u226555 mm determined by transthoracic echocardiogram within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory \n\n Patient is ambulatory and able to perform a 6MWT with the only limiting factor(s) being due to cardiovascular fitness \n\n Subject agrees to return for all required post-procedure follow-up visits \n\n The subject has been informed of the nature of the study and agrees to the study's provisions, including the possibility of randomization to the Control group, and has provided written informed consent as approved by the respective clinical site's Ethics Committee \n\n ", - "exclusion_criteria": ": \n\n Mitral regurgitation is primarily due to degenerative disease of the mitral valve apparatus (Degenerative mitral regurgitation), as determined by transesophageal echocardiography \n\n Status 1 heart transplant or prior orthotopic heart transplantation \n\n Introduction of a new heart failure drug class within the last 4 weeks prior to randomization \n\n Cardiovascular hospitalization within the last 2 weeks immediately prior to randomization \n\n Evidence of acute coronary syndrome, transient ischemic attack or stroke within 90 days prior to randomization \n\n Any percutaneous cardiovascular intervention, carotid surgery, cardiovascular surgery or atrial fibrillation ablation within 90 days prior to randomization \n\n Implant of any rhythm management device (i.e., pacemaker, Cardiac Resynchronization Therapy with or without cardioverter-defibrillator (CRT or CRT-D), or Implantable Cardioverter Defibrillator (ICD) within 90 days prior to randomization, or revision of any implanted rhythm management device within 90 days prior to randomization \n\n Need for any cardiovascular surgery \n\n Mitral valve surgery is considered a therapeutic option for the subject \n\n Renal replacement therapy \n\n Uncontrolled hypertension (i.e., BP >180 mmHg systolic and/or >105 mmHg diastolic) or hypotension (i.e., BP <90 mmHg systolic) \n\n Unstable angina pectoris as judged by the investigator, other clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias \n\n 6MWT distance >450 meters \n\n Mitral Valve Area (MVA) by planimetry <4.0 cm2; if MVA by planimetry is not measurable, pressure half-time measurement is acceptable; MVA must be confirmed by the Echocardiography Core Laboratory \n\n Leaflet anatomy which may preclude MitraClip device implantation, proper device positioning on the leaflets, or sufficient reduction in mitral regurgitation that may include: \n\n Evidence of calcification in the grasping area \n\n Presence of significant cleft in the grasping area \n\n Lack of both primary and secondary chordal support in the grasping area \n\n Prior mitral valve surgery \n\n Coaptation length \u22642 mm \n\n Leaflet mobility length <1 cm \n\n Presence of an IVC filter in the femoral vein that would interfere with the delivery catheter, or ipsilateral deep vein thrombosis (DVT) is present \n\n Contraindication to transseptal catheterization \n\n Subjects in whom transesophageal echocardiography is contraindicated \n\n Echocardiographic evidence of intracardiac mass, thrombus, or vegetation \n\n Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated) \n\n Presence of any of the following: \n\n Severe aortic stenosis (aortic valve area <1.0 cm2) or severe aortic regurgitation \n\n Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis) \n\n Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology \n\n Hemodynamic instability requiring inotropic support or mechanical heart circulatory support \n\n Active infections requiring current antibiotic therapy \n\n Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically \n\n Severe right ventricular failure or severe tricuspid regurgitation \n\n History of bleeding diathesis or coagulopathy or subject who refuses blood transfusions \n\n Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to randomization and be adherent to an accepted method of contraception \n\n Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the investigator \n\n Currently participating in another therapeutic or interventional heart failure trial, or in any trial of an unapproved drug or device (Subjects participating in observational studies or registries may be considered as eligible) \n\n Subject belongs to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures", - "brief_summary": "This trial is a randomized study of the MitraClip device in heart failure patients with clinically significant functional mitral regurgitation. A hierarchical composite of all-cause mortality and recurrent heart failure hospitalizations is hypothesized to occur at a lower rate with the use of the MitraClip device in addition to optimal standard medical therapy compared to optimal standard of care therapy alone.", - "NCTID": "NCT01772108" - }, - { - "brief_title": "Triage of Reduced Exercise Tolerance in Frail Elderly", - "phase": "", - "drugs": "['Index group']", - "drugs_list": [ - "Index group" - ], - "diseases": "['Heart Failure', 'Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Heart Failure", - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "841.0", - "inclusion_criteria": "inclusion criteria: \n\n patients aged 65 years and older \n\n must have a minimum of three chronic or vitality threatening diseases and/or use five or more medical drugs chronically in the last year \n\n must have dyspnea and/or reduced exercise tolerance (scored by two short questionnaires) \n\n ", - "exclusion_criteria": ": \n\n patients with both confirmed COPD and heart failure (Spirometry performed < 1 year ago and heart failure confirmed by echocardiography) \n\n patients unable or unwilling to sign informed consent", - "brief_summary": "Background of the study:~Many elderly suffer from reduced exercise tolerance or exercise induced shortness of breath (dyspnoea) which causes decreased mobility and restrictions in physical, psychological and social functioning. Patients commonly attribute this symptom to their age, and simply adjust their life style to it. Reduced exercise tolerance/dyspnoea is very common with prevalence rate of 20-60% of those aged 65 years and over. The main causus in the elderly are heart failure and chronic obstructive pulmonary disease (COPD). Both diseases have a high negative impact on the quality of life and are associated with frequent hospital admissions. Over-diagnosis, but more often under-diagnosis of heart failure and COPD is rather common in primary care. Establishing a diagnosis early in the course of the disease is useful because both diseases can be adequately and evidence-based treated. Therefore, an easy diagnostic triage-strategy followed bij direct treatment would be of great importance to asses and treat heart failure and COPD in elderly patient with shortness of breath.~Objective of the study:~Quantify how many frail elderly aged over 65 years with reduced exercise tolerance and/or exercise induced dyspnoea have previously unrecognised COPD and heart failure. Quantify the difference in prevalence of unrecognised COPD and heart failure between those who underwent the diagnostic triage compared to those who received care as usual. Quantify the effect of the diagnostic triage plus the additionally treatment changes on functionality and quality of life after 6 months compared to those who received care as usual. Quantify the cost-effectiveness of the diagnostic triage strategy compared to care as usual~Study design:~A clustered randomized diagnostic (follow-up) study~Study population:~First, pre-selection of patients aged over 65 years from 50 general practices is based on frailty. Frailty is based on the next criteria: use 5 or more different types of medical drugs chronically in the last year and/or have 3 or more chronic or vitality treating diseases (such as diabetes mellitus, COPD, heart failure, impaired vision). This will be done from the electronic medical files of the general practices. These elderly will receive the MRC questionnaire of dyspnoea and three additional questions related tot exercise intolerance. Those with any dyspnoea and/or reduced exercise tolerance will be invited to participate, except those with established heart failure and COPD.~Study parameters/outcome of the study:~Prevalence of latent heart failure and COPD. Difference in prevalence of latent heart failure and COPD between both groups.~Differences in functionality and quality of life after 6 months between both groups. Cost-effectiveness and experienced patient burden of the diagnostic triage strategy.", - "NCTID": "NCT01148719" - }, - { - "brief_title": "Comparison of Long- and Short-acting Diuretics in Congestive Heart Failure", - "phase": "Phase 4", - "drugs": "['furosemide', 'azosemide']", - "drugs_list": [ - "furosemide", - "azosemide" - ], - "diseases": "['Congestive Heart Failure']", - "diseases_list": [ - "Congestive Heart Failure" - ], - "enrollment": "320.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of heart failure based on a slight modification of the Framingham criteria as previously described within 6 months before the entry \n\n Current status of heart failure is NYHA II or III. \n\n Currently, loop diuretic(s) is (are) administered. \n\n No change in baseline therapy and symptoms of heart failure within a month \n\n ", - "exclusion_criteria": ": \n\n Current symptomatic hypotension \n\n Hypertension that has not been controlled to the satisfaction of the investigator \n\n Hemodynamically significant (in the investigators opinion) LV outflow tract obstruction (due to either aortic stenosis or ventricular hypertrophy) \n\n Acute coronary syndrome \n\n Primary pulmonary hypertension or pulmonary hypertension not due to LV dysfunction \n\n Serious cerebrovascular disease \n\n Acute myocardial infarction within the last 3 months \n\n Patients who require intravenous inotropes \n\n Cerebrovascular accident within the last 3 months \n\n Percutaneous coronary intervention or open heart surgery within the last 3 months \n\n On the waiting list for percutaneous coronary intervention or open heart surgery \n\n Serum creatinine > 2.5 mg/dl \n\n Serious liver disease \n\n Any change in cardiovascular drug therapy within a month prior to randomization \n\n History of chronic obstructive pulmonary disease or restrictive lung disease \n\n Diabetes mellitus that has not been well controlled (fasting blood glucose>200 mg/dl\u3001HbA1c > 8%) \n\n Any life-threatening acute disease \n\n Patients with implantable cardiac defibrillator \n\n Other diseases likely to cause death or serious disability during the period of the study \n\n Patients unable to walk without personal aid", - "brief_summary": "The purpose of this study is to compare therapeutic effects of furosemide, a short-acting loop diuretic, and azosemide, a long-acting one, in patients with heart failure, and to test our hypothesis that long-acting diuretics are superior to short-acting types in heart failure.", - "NCTID": "NCT00355667" - }, - { - "brief_title": "Safety/Tolerability, Pharmacokinetics/Pharmacodynamics (PK/PD) of LCZ696 in Patients With Stable Heart Failure", - "phase": "Phase 2", - "drugs": "['LCZ696']", - "drugs_list": [ - "LCZ696" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with documented heart failure (NYHA class II-IV) \n\n ", - "exclusion_criteria": ": \n\n Use of both ACEi and ARB, ACEi and DRI, ARB and DRI treatment, or all three medications at Screening", - "brief_summary": "This study assess the safety/tolerability, PK/PD of LCZ696 in patients with stable heart failure.", - "NCTID": "NCT00913653" - }, - { - "brief_title": "Safety and Efficacy of the Combination of Loop With Thiazide-type Diuretics in Patients With Decompensated Heart Failure", - "phase": "Phase 3", - "drugs": "['hydrochlorothiazide', 'Placebo']", - "drugs_list": [ - "hydrochlorothiazide", - "Placebo" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "232.0", - "inclusion_criteria": "inclusion criteria: \n\n History of chronic heart failure \n\n Admission for acute decompensated heart failure \n\n There is no prespecified inclusion criterion with respect to heart failure etiology and/or ejection fraction \n\n Receipt of an oral loop diuretic for at least 1 month before hospitalization, at a dose between 80 mg and 240 mg daily in the case of furosemide and an equivalent dose in the case of a different loop diuretic (20 mg of torasemide or 1 mg of bumetanide was considered to be equivalent to 40 mg of furosemide) \n\n ", - "exclusion_criteria": ": \n\n Other etiologies of fluid overload different from heart failure \n\n Hyponatremia: any symptomatic sodium value or a sodium level below 125mmol/l \n\n Unstable patients: acute coronary syndrome, cardiogenic shock or ICU admission. \n\n Patients requiring inotropic agents or renal replacement therapies \n\n Life expectancy < 6 months \n\n Prior treatment with thiazide-type diuretics \n\n Aldosterone antagonists are permitted if the patient had been taking them on a long-term basis (at least 30 days before randomisation) \n\n Pregnancy or breastfeeding period \n\n Active alcoholism and/or other substance abuse", - "brief_summary": "The purpose of this study is to determine whether a combined diuretic therapy (loop diuretics with thiazide-type diuretics) is more effective (in terms of improving fluid overload symptoms) among patients with decompensated heart failure in comparison with loop diuretic alone.", - "NCTID": "NCT01647932" - }, - { - "brief_title": "Dynamic Carbon Dioxide (CO2) Administration for Sleep Apnoea", - "phase": "Phase 2", - "drugs": "['Carbon dioxide', 'Carbon dioxide']", - "drugs_list": [ - "Carbon dioxide", - "Carbon dioxide" - ], - "diseases": "['Sleep Apnea, Central']", - "diseases_list": [ - "Sleep Apnea", - "Central" - ], - "enrollment": "24.0", - "inclusion_criteria": "inclusion criteria: \n\n Men and women 18 to 79 years of age who have New York Heart Association (NYHA) functional class I through IV heart failure due to ischemic, hypertensive, or idiopathic dilated cardiomyopathy and whose condition had been stabilized by means of optimal medical therapy for at least one month; \n\n An LVEF of less than 40% and central sleep apnea, defined as 15 or more episodes of apnea and hypopnea per hour of sleep, more than 50 percent of which are determined to be central rather than obstructive. \n\n ", - "exclusion_criteria": ": \n\n Pregnancy, \n\n Myocardial infarction, \n\n Unstable angina or cardiac surgery within the previous three months.", - "brief_summary": "Normally breathing is controlled by a reflex that responds to the levels of carbon dioxide (CO2) in the blood. In heart failure, where the heart muscle is damaged and therefore does not pump as well, this reflex is exaggerated. The result is a vicious circle: blood CO2 levels fluctuate wildly and as a result breathing also fluctuates with patients hyperventilating at times and briefly stopping breathing at others. During sleep this is called central sleep apnoea (CSA).~Patients with CSA wake up throughout the night and whilst some patients are oblivious to this, others are consciously breathless and many patients are tired during the day and feel unable to perform their daily activities.~As part of the body's stress response to the erratic pattern of breathing, both blood pressure and heart rate may rise to a level that is harmful in a failing heart, exacerbating the underlying heart failure. Indeed patients who demonstrate this CSA die sooner than those who have heart failure and stable breathing.~There are no proven specific therapies for CSA that stabilise breathing, improve sleep quality, and prolong life. We have designed a system which delivers very small doses of CO2, when the blood level of CO2 is predicted to be low. During short daytime recordings, using this system, we have demonstrated that it is possible to stabilise the body's CO2 levels.~We aim to test what happens when CO2 is given overnight whilst the patient is sleeping to see whether we can stabilise their breathing over longer durations and whether sleep quality could be improved so that patients are less tired during the day. In addition, we would like to measure whether the stress response is lessened if the breathing is successfully stabilised.", - "NCTID": "NCT01041924" - }, - { - "brief_title": "Safety and Effectiveness of Drug up Titration by Nurses Specialized in Heart Failure (HF) Patients", - "phase": "", - "drugs": "['Heart Failure (HF) nurse up-titration', 'Heart Failure (HF) cardiologist up-titration']", - "drugs_list": [ - "Heart Failure (HF) nurse up-titration", - "Heart Failure (HF) cardiologist up-titration" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "320.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient with de novo heart Failure and LVEF <= 40% admitted in hospital, without contraindications for BB prescription with cardiologist up-titration prescription and without having achieved BB target dose previous discharge and signing informed consent. \n\n ", - "exclusion_criteria": ": \n\n Contraindications for BB. \n\n Living in a nursing home. \n\n Life expectancy < 6 months. \n\n Unable to self-care or mental disease without caregiver. \n\n Unable to weight \n\n Without phone \n\n Unable to go to clinic visit.", - "brief_summary": "Introduction: Heart Failure (HF) generates multiple hospital admissions and mortality, which are reduced with the administration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) drugs (Level of Evidence A). The effect is dose-dependent. Nevertheless, dosages are suboptimal. European Guidelines 2012 recommend close monitoring and up-titration of drugs by HF nurses. Trials are needed to evaluate their effectiveness and safety. Objective: To compare doses achieved by patients of BB, ACEI, ARB II and MRA in 4 months ( % relative to target doses) in the intervention group (HF nurse) and in the control group ( cardiologist), adverse events, Left Ventricular Ejection Fraction (LVEF), New York Heart Association (NYHA), 6 min. walking test, quality of life, Nt-proBNP, readmissions and mortality. Hypothesis: Non-inferiority. Design: Multicenter randomized controlled trial. New (de novo) HF patients with LVEF \u2264 40%, NYHA II-III, without contraindications to BB of 17 Spanish hospitals will be included. Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration. In the control group doses are decided by the cardiologist clinical support and education being provided by nurses. Variables: age, sex, education, psycho-social level, Cardio Vascular Risk Factors (CVRF), NYHA, LVEF, ischemic cardiopathy., N-terminal pro B-type natriuretic peptide (Nt-proBNP), 6min. walking test, Creatinine/Glomerular Filtration Rate (GFR), Potassium (K), haemoglobin, Blood Pressure (BP), Heart Rate (HR), mg./drug, European Heart Failure Self-Care Behaviour Scale (EHFScBS), Minnesota Living with Heart Failure questionnaire (MLHFQ), European Quality of life Scale (EQ-5D). Expected Results: If our hypothesis were confirmed, evidence would be provided on the effectiveness of this healthcare management, that could be economically evaluated in future studies. A qualitative study also will be undertaken to explore barriers and facilitators to implementation", - "NCTID": "NCT02546856" - }, - { - "brief_title": "Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device", - "phase": "Phase 2", - "drugs": "['Paradym CRT + Physiological Diagnosis (PhD)']", - "drugs_list": [ - "Paradym CRT + Physiological Diagnosis (PhD)" - ], - "diseases": "['Congestive Heart Failure']", - "diseases_list": [ - "Congestive Heart Failure" - ], - "enrollment": "520.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject eligible for implantation of a CRT-D device according to current available guidelines for cardiac resynchronization therapy \n\n Subject has severe heart failure (NYHA Class III or IV) \n\n Subject has experienced at least one heart failure event within six months prior to enrollment \n\n Subject continues to have heart failure symptoms despite receiving optimal medical therapy \n\n Schedule for implant of a PARADYM CRT-D (Model 8770) \n\n Subject has signed and dated an informed consent form \n\n ", - "exclusion_criteria": ": \n\n Any contraindication for standard cardiac pacing \n\n Any contraindication for ICD therapy \n\n Abdominal implantation site \n\n Hypertrophic or obstructive cardiomyopathy \n\n Acute myocarditis \n\n Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month \n\n Recent (within the last month) or planned cardiac revascularization or coronary angioplasty \n\n Correctable valvular disease that is the primary cause of heart failure \n\n Mechanical tricuspid valve \n\n Receiving continuous intra-venous infusion of positive inotropic therapy or intermittent therapy (intravenous infusion) more than twice per week \n\n Heart transplant recipient \n\n Renal insufficiency requiring dialysis \n\n Already included in another clinical study \n\n Life expectancy less than 12 months \n\n Inability to understand the purpose of the study or refusal to cooperate \n\n Inability or refusal to provide informed consent or HIPAA \n\n Unavailability for scheduled follow-up at the implanting center \n\n Known sensitivity to 1mg dexamethasone sodium phosphate (DSP) \n\n Under guardianship \n\n Age of less than 18 years \n\n Pregnancy", - "brief_summary": "The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This trial will study the effectiveness of the diagnostic feature to detect heart failure events in medically stable, ICD-indicated, congestive heart failure patients.", - "NCTID": "NCT00957541" - }, - { - "brief_title": "Group Psychotherapy Among Congestive Heart Failure Patients", - "phase": "", - "drugs": "['Existential Group Therapy']", - "drugs_list": [ - "Existential Group Therapy" - ], - "diseases": "['Congestive Heart Failure (CHF)']", - "diseases_list": [ - "Congestive Heart Failure (CHF)" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of heart failure at levels III and IV, according to the classification of the NYHA (New York Heart Association) for 3 months or more. \n\n Clinical diagnosis of LVEF less than 50% or were on diuretic therapy for more than three months with at least one previous hospitalization due to heart failure disease. \n\n ", - "exclusion_criteria": ": \n\n uncertain prognosis for 12 months due to other conditions. \n\n acute coronary disease in recent months. \n\n existence of another life-threatening illness of the patient (such as active cancer, chronic kidney failure). \n\n severe neurological problem (Brain syndrome / orientation problem/ difficult peripheral neuropathy). \n\n severe mental illness (active psychosis / suicide risk / severe dementia). \n\n linguistic limitations (such as misunderstanding of the Hebrew language / stuttering / untreated audio impairment). \n\n a significant functional problem (such as unconsciousness / connection to respiration device / confined to a wheelchair or bed / severe walking disability / needs help with complete basic daily activities). \n\n objective limit that endangers liability for participation in the seven meetings (such as remote residential / tourist / convict / drug addict). \n\n subjects whose mother tongue is not Hebrew.", - "brief_summary": "This study will examine the efficacy of group therapy utilizing the Existential Approach in heart failure patients when compared to a control group of patients who are waiting for the same group treatment. This comparison will be achieved by measuring changes in the variables studied namely, the levels of psychological distress and levels of psycho-social adjustment.", - "NCTID": "NCT01414439" - }, - { - "brief_title": "Evaluation of the Samsung LABGEO IVD-A20 CHF Test in a Point-of-Care Setting", - "phase": "", - "drugs": "['Samsung LABGEO IVD-A20 CHF Test']", - "drugs_list": [ - "Samsung LABGEO IVD-A20 CHF Test" - ], - "diseases": "['Congestive Heart Failure']", - "diseases_list": [ - "Congestive Heart Failure" - ], - "enrollment": "191.0", - "inclusion_criteria": "inclusion criteria: \n\n CHF Subjects: 21 years of age or greater, with clinically confirmed CHF or have presented to the clinical site with signs, symptoms and/or risk factors suggestive of heart failure. \n\n Subjects with Potentially confounding comorbidities: Non-CHF subjects 21 years of age or greater, with potentially confounding comorbidities such as diabetes, renal insufficiency, hypertension and chronic obstructive pulmonary disease (COPD) \n\n Healthy Subjects: apparently healthy subjects greater than 45 years of age, with no prior history of cardiac-related disease. \n\n ", - "exclusion_criteria": ": \n\n Apparently healthy subjects with a history of MI, CHF or other cardiac-related disease; \n\n Subjects with acute decompensated heart failure currently on nesiritide therapy; \n\n Subjects having participated in another experimental drug, biologic, or invasive device study within 30 days prior to signing informed consent for this study, or enrolled concurrently in any other investigative study; and \n\n Subjects unable to or refusing to provide written informed consent.", - "brief_summary": "To establish the performance characteristics of the Samsung LABGEO IVD-A20 CHF Test in intended use settings, by comparing test results of the A20 CHF Test with results obtained from an FDA-cleared comparator assay.", - "NCTID": "NCT02107495" - }, - { - "brief_title": "REBEAT Resynchronisation and Beta-Blocker European Trial", - "phase": "Phase 4", - "drugs": "['Contak Renewal (CRT-D)']", - "drugs_list": [ - "Contak Renewal (CRT-D)" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "354.0", - "inclusion_criteria": "inclusion criteria: \n\n Symptomatic heart failure and indication for cardiac resynchronization therapy (CRT), Hemodynamic stability with documented intolerance to beta-blocker therapy or treatment with beta-blocking agents at sub-optimal dosages (<25% of optimal dosage). \n\n ", - "exclusion_criteria": ": \n\n chronic atrial fibrillation; indications for permanent antibradycardia pacing; mechanical tricuspid valve; Severe aortic stenosis or other primary valve disease causing cardiomyopathy", - "brief_summary": "This protocol will evaluate the effect of cardiac resynchronization therapy (CRT) combined with beta-blocker therapy in patients with symptomatic heart failure in whom beta-blocker therapy was either not tolerated or could not be up titrated to optimal doses before CRT. Cardiac resynchronization therapy will be combined with automatic implantable cardioverter defibrillator (AICD, CRT-D) as it has been shown to be associated with an improvement in prognosis in the patients with left ventricular systolic dysfunction and heart failure.", - "NCTID": "NCT00305526" - }, - { - "brief_title": "Genomic Response Analysis of Heart Failure Therapy in African Americans", - "phase": "", - "drugs": "['FDC I/H']", - "drugs_list": [ - "FDC I/H" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "225.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years and older \n\n History of heart failure with an LVEF (less than OR equal to) < 0.35 for at least 6 months OR an LVEF < 0.45 with left ventricular internal end diastole (defined by a diameter of more than 2.9 cm per square meter of body surface area OR more than 6.5 cm on the basis of echocardiography). ** Echo must be done within 6 months of enrollment** \n\n New York Heart Association (NYHA) Class II-IV \n\n Background heart failure therapy that includes angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs), and beta blockers (BBs) for at least 3 months (or documentation of intolerance to ACEi/ARBs and BBs) \n\n Self-designated race as African American or black (would include subjects whose country of origin was outside the USA such as Africa, the Caribbean, or Central America). \n\n ", - "exclusion_criteria": ": \n\n History of intolerance to either nitrates or hydralazine \n\n Treatment with the combination of hydralazine and nitrates for the previous 3 months \n\n Revascularization or myocardial infarction within last 90 days \n\n Received cardiac resynchronization therapy (CRT) AND did not have an assessment of cardiac function documenting an LVEF < 35% (less than OR equal to 35%) at least 90 days post CRT \n\n Presence of clinically significant valvular heart disease, hypertrophic or restrictive cardiomyopathy, active myocarditis, or uncontrolled hypertension. (Note that uncontrolled hypertension is defined as blood pressure consistently greater than 160 mmHg systolic and 95 mmHg diastolic) \n\n Women who are currently pregnant, planning on becoming pregnant in the next two years, or those who do not agree to prevent pregnancy. \n\n Subjects who are on continuous home inotropes, a left ventricular assist device, or who are post cardiac transplant.", - "brief_summary": "The response to therapy with a fixed dose combination of isosorbide dinitrate and hydralazine (FDC I/H) is enhanced in African Americans with heart failure and reduced ejection fraction (HFrEF) when compared to similar white cohorts. This study will seek to confirm the previous genetic sub-study from AHeFT which suggested a functional polymorphism of guanine nucleotide binding protein beta polypeptide 3 subunit (GNB3), C825T in exon 10, influences the therapeutic efficacy of FDC I/H. This study will initiate treatment with FDC I/H in 500 self designated African American subjects with systolic heart failure. They will be followed for up to two years on therapy. Clinical outcomes (survival, heart failure hospitalizations, and change in quality of life) on FDC I/H will be compared by GNB3 genotype subset. The hypothesis to be confirmed is that subjects homozygous for the T allele (those with the GNB3 TT genotype which is present in approximately 50% of black subjects) demonstrate enhanced therapeutic benefit from FDC I/H.", - "NCTID": "NCT02305095" - }, - { - "brief_title": "Prospective Aerobic Reconditioning Intervention Study", - "phase": "", - "drugs": "['Exercise', 'Control']", - "drugs_list": [ - "Exercise", - "Control" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "201.0", - "inclusion_criteria": "inclusion criteria: \n\n Age greater than or equal to 60 years of age \n\n Symptoms of congestive heart failure \n\n Able to understand and give informed consent \n\n ", - "exclusion_criteria": ": \n\n Age <60 years \n\n Does not have CHF \n\n Significant change in cardiac medication <3 weeks \n\n Myocardial infarction <3 weeks \n\n CABG surgery <3 months \n\n Angina pectoris not controlled during daily activity by pharmacological therapy or at <4 METS activity \n\n Sustained hypertension with systolic> 190 and diastolic> 110 on medications \n\n Valvular heart disease as the primary etiology of CHF \n\n Significant aortic stenosis \n\n Stroke of <3 months or with any physical restriction impairment that would prevent participation in exercise programs \n\n Chronic obstructive pulmonary disease on therapy that limits exercise duration \n\n Uncontrolled diabetes mellitus \n\n Active treatment for cancer or other noncardiovascular conditions with life expectancy less than three years \n\n Anemia 10 gms Hb) \n\n Renal insufficiency (cr >2.5 mg/dl) \n\n Psychiatric disease - uncontrolled major psychoses, depressions, dementia, or personality disorder \n\n Dementia - MMSE \n\n 24 22 for \n\n 8th grade education) \n\n Lack of an acoustic window sufficient to allow definition of endocardial borders on the screening echocardiogram. \n\n Plans to leave area or be admitted to a nursing home within 2 years. \n\n Inability to walk at least 420 feet in 6 minutes without a cane or other assistive device. \n\n Inability to exercise at or near home. \n\n At the discretion of the clinical staff, it is believed that the participant cannot or will not complete the protocol because of frailty, illness, or other reason. \n\n Participation in a regular exercise regimen more than one time per week for at least twenty minutes per session; including but not limited to walking, swimming, weight lifting, golfing, or taking an exercise class. \n\n Inability to ambulate without cane or other assistive device during biomechanics testing or treadmill. \n\n Inability to attend at least fourteen weeks of the facility-based intervention", - "brief_summary": "The purpose of this study is :~To determine if aerobic exercise conditioning can improve symptoms, cardiovascular function and quality of life in elderly patients with congestive heart failure.~To describe the baseline clinical characteristics, cardiovascular function and neurohumoral function in elderly patients with congestive heart failure.~To determine the specific cardiovascular and noncardiovascular mechanisms by which symptoms and quality of life may improve following exercise conditioning in elderly patients with congestive heart failure.", - "NCTID": "NCT01113840" - }, - { - "brief_title": "The Influence of Beta Blocker Therapy on the Hemodynamic Response to Inotrope Infusion in Patients With Acute Decompensated Heart Failure", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Acute Decompensated Heart Failure', 'Heart Failure']", - "diseases_list": [ - "Acute Decompensated Heart Failure", - "Heart Failure" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients \u2265 18 years of age and English-speaking who are admitted to the General Cardiology or Heart Failure Services at the University of North Carolina Hospitals with acute decompensated heart failure (ADHF). \n\n Patients deemed by the health care team to require hemodynamic monitoring with a pulmonary artery catheter and inotropic therapy. Patients receiving at least 3 doses of continued beta blocker therapy with carvedilol, metoprolol succinate, or metoprolol tartrate and patients receiving no beta blocker therapy or have missed at least 5 doses of beta-blocker therapy. \n\n ", - "exclusion_criteria": ": \n\n Concomitant treatment with other beta blockers, non-selective alpha blockers (e.g. terazosin, prazosin, doxazosin), non-dihydropyridine calcium antagonists, antiarrhythmic agents except for chronic stables doses of amiodarone, dofetilide or mexiletine. \n\n Use of inotropes or IV vasoactive agents within 7 days or at time of enrollment Patients with hemodynamically unstable arrhythmias (e.g., Systolic Blood Pressure (SBP) < 80, Heart Rate (HR) > 110), uncorrected primary valvular disease, or current mechanical support including left ventricular assist device (LVADs), Impella devices and balloon pumps \n\n Patients who have missed more than 1 dose of beta blocker within 72 hours of starting inotrope \n\n No subjects will be excluded based upon race, gender or ethnicity.", - "brief_summary": "Purpose: To compare the hemodynamic effects of dobutamine and milrinone in hospitalized patients who are receiving Beta Blocker Participants: Patients who are admitted to the General Cardiology and Heart Failure Services at the University of North Carolina Hospitals with acute decompensated heart failure, who have maintained steady state concentrations of beta blocker therapy (carvedilol or metoprolol), and who are deemed by the health care team to require pulmonary artery catheter placement and inotropic therapy with dobutamine or milrinone by continuous infusion. Patients that are not currently receiving beta blocker therapy will be enrolled for comparative purposes; however, any patient not at steady state (on or off beta blocker therapy) will not be enrolled.~Procedures: After obtaining informed consent, patients will be assigned to the appropriate sub-study group based on beta blocker use (Study A: patients on stable doses of metoprolol and Study B: patients on stable doses of carvedilol). All patients should receive dobutamine followed by milrinone as outlined in the dosing algorithm (see inotrope dosing algorithm attached, as part of the usual standard of practice). Baseline pulmonary artery catheter hemodynamic parameters will be collected prior to administration of inotrope trial of dobutamine followed by milrinone. Hemodynamic parameters will be recorded per the dosing algorithm following initiation and dose titration. Dose titration will be determined by the health care team based upon patient response or lack thereof and tolerability. Changes in hemodynamic parameters in response to dobutamine or milrinone will be compared within study groups. Additionally, data will continue to be collected on patients receiving not beta blocker therapy for comparative purpose.", - "NCTID": "NCT01971944" - }, - { - "brief_title": "Multiple Patient Program to Ensure Access to LCZ696 Treatment to Patients Diagnosed With Heart Failure With Reduced Ejection Fraction (HF-rEF)", - "phase": "", - "drugs": "['LCZ696']", - "drugs_list": [ - "LCZ696" - ], - "diseases": "['Heart Failure With Reduced Ejection Fraction (HF-rEF)']", - "diseases_list": [ - "Heart Failure With Reduced Ejection Fraction (HF-rEF)" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria \n\n The patient(s) for whom the MPP is sought meets all of the following: \n\n Is suffering from a serious or life-threatening disease or condition \n\n Does not have access to a comparable or satisfactory alternative treatment (i.e., comparable or satisfactory treatment is not available or does not exist) \n\n Patient should be on optimized standard of care treatment, including treatment with ARBs or ACEI, beta-blockers and MRA; \n\n Intolerance to evidence-based target doses should be documented by the treating physician \n\n Meets any other relevant medical criteria for compassionate use of the investigational product \n\n Patients eligible for inclusion in this program have to fulfill all of the following criteria: \n\n Adult patients (but not younger than 18 year old) will be included, upon completion of written informed consent before any assessment is performed. \n\n Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction: \n\n \u2022 LVEF \u2264 35% at the time of screening for participation in the program (any local measurement, made within the past 6 months using echocardiography, MUGA, CT scanning, MRI or ventricular angiography is acceptable, provided there are no subsequent measurement above 35%) \n\n Patient had a hospitalization for HF within the last 12 months \n\n Patients must be on an ACEI or an ARB at a stable dose for at least 4 weeks prior to starting treatment with LCZ696 \n\n Patients must be treated with a \u03b2-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to starting treatment with LCZ696 (reason should be documented for patients not on CHF target doses per local guidelines, or in absence of that medication). \n\n An aldosterone antagonist should also be considered in all patients, taking account of renal function, serum potassium and tolerability. If given, the dose of aldosterone antagonist should be optimized according to guideline recommendations and patient tolerability, and should be stable for at least 4 weeks prior to starting treatment with LCZ696 \n\n ", - "exclusion_criteria": " \n\n Patients fulfilling any of the following criteria are not eligible for inclusion in this program: \n\n The patient is eligible for participation in any of the IMP's ongoing clinical trials \n\n The patient has recently completed a clinical trial that has been terminated and other options (e.g., trial extensions, amendments, etc.) are available to continue a similar treatment. \n\n The patient is being transferred from an ongoing clinical trial for which the patient is still eligible for participation \n\n History of hypersensitivity or allergy to LCZ696 or to any of its metabolites; to drugs of similar chemical classes, ARBs, or NEP inhibitors; as well as known or suspected contraindications to LCZ696 \n\n Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer \n\n Previous history of intolerance to recommended target doses of ARBs \n\n Known history of angioedema \n\n Requirement of concomitant treatment with both ACEIs and ARBs \n\n Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy) \n\n Symptomatic hypotension and/or a SBP less than 100 mm Hg over the last 4 weeks prior to starting treatment with LCZ696 \n\n Estimated GFR below 30 mL/min/1.73m2 as measured by the simplified MDRD formula \n\n Presence of bilateral renal artery stenosis \n\n Serum potassium above 5.2 mmol/L during the week prior to starting treatment with LCZ696 \n\n Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within the 3 months prior to starting treatment with LCZ696 \n\n Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after the schedule date to start treatment with LCZ696 \n\n Implantation of a cardiac resynchronization therapy pacemaker (CRT-P) or a cardiac resynchronization therapy defibrillator (CRT-D) or upgrading of an existing conventional pacemaker or an implantable cardioverter defibrillator (ICD) to CRT device within 3 months prior to starting treatment with LCZ696, or intent to implant such a device. \n\n Also, patients who had implantation of a conventional pacemaker or an ICD or had a revision of a pacemaker or other device leads within 1 month before starting treatment with LCZ696 are excluded. \n\n Heart transplant or ventricular assistance device (VAD) or intent to transplant (on transplant list) or implant a VAD \n\n History of severe pulmonary disease \n\n Diagnosis of peripartum or chemotherapy induced cardiomyopathy within the 12 months prior to starting treatment with LCZ696 \n\n Documented untreated ventricular arrhythmia with syncopal episodes within the 3 months prior to starting treatment with LCZ696 \n\n Symptomatic bradycardia or second or third degree heart block without a pacemaker \n\n Presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation \n\n Presence of other hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis \n\n Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs, including but not limited to any of the following: \n\n History of active inflammatory bowel disease during the 12 months before starting treatment with LCZ696. \n\n Current duodenal or gastric ulcers during the 3 months prior to starting treatment with LCZ696 \n\n Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 2 x ULN prior to starting treatment with LCZ696, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt \n\n Active treatment with cholestyramine or colestipol resins \n\n Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 3 x ULN prior to starting treatment with LCZ696, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt \n\n Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (above 5 mIU/mL) \n\n Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method (if accepted by the local regulatory authority and ethics committee) or a barrier method plus a hormonal method \n\n Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progesterone agent. \n\n Reliable contraception should be maintained throughout the treatment and for 7 days after LCZ696 treatment discontinuation \n\n Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea, or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. \n\n Presence of any other disease with a life expectancy of < 3 years \n\n Any condition, not identified in the protocol that in the opinion of the treating physician is likely to prevent the patient from safely tolerating LCZ696 or complying with the requirements of the therapy.", - "brief_summary": "Novartis has set up this global Multiple Patient Program (MPP) treatment plan to provide access to life-saving treatment with LCZ696 for patients that were not previously exposed to LCZ696 but have no other option to receive LCZ696 in their country prior to market authorization OR commercial availability, based on local regulatory and legal requirements.", - "NCTID": "NCT02389933" - }, - { - "brief_title": "EarlySense Monitoring Device Evaluation on CHF Patients", - "phase": "", - "drugs": "['EarlySense monitoring device']", - "drugs_list": [ - "EarlySense monitoring device" - ], - "diseases": "['Congestive Heart Failure']", - "diseases_list": [ - "Congestive Heart Failure" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Age over 45 years old \n\n CHF class II or III with LVEF<40% \n\n Hospitalized at least once for CHF deterioration over previous 12 month period \n\n Able and willing to cooperate with this trial for at least a 3 month period \n\n Home close to participating center \n\n ", - "exclusion_criteria": ": \n\n Recent (within 3 month) admission to ICU or CC-ICU due to severe CHF episode requiring artificial ventilation \n\n Asthma or COPD", - "brief_summary": "CHF patients will be monitored using EarlySense ES-16 device and will simultaneously fill diaries and log their weight daily. The data collected and analyzed by the ES-16 device will be correlated with the CHF status data.", - "NCTID": "NCT00382746" - }, - { - "brief_title": "BOAT: Beta Blocker Uptitration With OptiVol After Cardiac Resynchronization Therapy (CRT)", - "phase": "Phase 4", - "drugs": "['Beta blocker (carvedilol or metoprolol succinate)', 'CRT (cardiac resynchronization therapy)']", - "drugs_list": [ - "Beta blocker (carvedilol or metoprolol succinate)", - "CRT (cardiac resynchronization therapy)" - ], - "diseases": "['Congestive Heart Failure']", - "diseases_list": [ - "Congestive Heart Failure" - ], - "enrollment": "2.0", - "inclusion_criteria": "inclusion criteria: \n\n NYHA III-IV \n\n QRS > 120 msec \n\n On medical therapy, but beta blocker dose not @ target (carvedilol 25 bid, metoprolol succinate 200 qd) \n\n ", - "exclusion_criteria": ": \n\n QRS < 120 msec \n\n On target beta blocker dose", - "brief_summary": "Many heart failure patients are unable to reach target beta blocker doses. This study will address whether cardiac resynchronization therapy (CRT) will enable uptitration of beta-blockers to target doses and whether it will favorably affect remodeling by reducing left ventricular end systolic volume (LVESV), with measurable clinical benefit, beyond CRT alone (without changes in beta-blocker dose).", - "NCTID": "NCT00433043" - }, - { - "brief_title": "Study to Characterize Atrial Fibrillation in CHF Patients Indicated for CRT", - "phase": "Phase 4", - "drugs": "['Vitatron biventricular pacemaker']", - "drugs_list": [ - "Vitatron biventricular pacemaker" - ], - "diseases": "['Congestive Heart Failure, Atrial Fibrillation']", - "diseases_list": [ - "Congestive Heart Failure", - "Atrial Fibrillation" - ], - "enrollment": "172.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient is willing and able to comply with the protocol \n\n Patient is willing to sign written informed consent \n\n Patient is expected to remain available for Follow-up visits \n\n Patient age is 18 years and older \n\n patient is on a stable medication regimen (including beta blockers) for at least 4 weeks prior to enrollment \n\n Baseline criteria: patients should meet all of the following criteria, to be determined at the baseline assessment procedure within 4 weeks prior to device implantation: - New York Heart Association functional classification III or IV \n\n QRS duration > 130 ms \n\n Left ventricular ejection fraction < 35% measured by echocardiography left ventricular end diastolic dimension > 55 mm measured by echocardiography \n\n ", - "exclusion_criteria": ": \n\n Patients with unstable angina or who have experienced an acute myocardial infarction or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within 3 months prior to enrollment or who are candidates for CABG or PTCA \n\n Patients who have experienced CVA or TIA with permanent disability within 3 months prior to enrollment \n\n Patient on, or anticipated to require, intravenous inotropic drug therapy \n\n Patients with severe primary pulmonary disease (such as cor pulmonale) \n\n Post heart transplant patients and patients on an urgency list for cardiac transplantation \n\n Supine systolic blood pressure greater than 170 mm \n\n Patient who are not expected to survive for 8 months of study participation due to other medical conditions \n\n Women who are pregnant or with child bearing potential and who are not on a reliable form of birth control \n\n Serum creatinine greater than 250 mol/l \n\n Untreated hyperthyroidism \n\n Patients enrolled in any concurrent (drug and/or device) study \n\n Patients with an existing implantable cardioverter defibrillator (ICD) or indications for an ICD including those patients with sustained VT within the previous month \n\n Patients with permanent atrial arrhythmias. Permanent atrial arrhythmia is defined as an arrhythmia for which any possible type of cardioversion is not considered or that is recurrent within 24 hours from an attempted cardioversion \n\n Patients with contraindications for implantation of a cardiac pacing device \n\n Patients who are already implanted with a cardiac pacing device for purposes other than Cardiac Resynchronization Therapy", - "brief_summary": "The purpose of the study is to characterize atrial arrhythmias in patients indicated for Cardiac Resynchronization Therapy (CRT) and to monitor changes in atrial arrhythmias while CRT is provided.", - "NCTID": "NCT00156728" - }, - { - "brief_title": "Resynchronization Therapy in Young Patients With and Without CHD", - "phase": "", - "drugs": "['congestive heart failure patients']", - "drugs_list": [ - "congestive heart failure patients" - ], - "diseases": "['Dilated Cardiomyopathy', 'Pediatric']", - "diseases_list": [ - "Dilated Cardiomyopathy", - "Pediatric" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosed with dilated cardiomyopathy \n\n normal heart anatomy or those with repaired congenital defects that have a 4 chambered heart \n\n referred for a Biventricular pacemaker implantation or upgrade with the diagnosis of dilated cardiomyopathy or for an echocardiogram due to the diagnosis of dilated cardiomyopathy without pacemaker \n\n signed informed consent \n\n ", - "exclusion_criteria": ": \n\n cannot travel back to Children's Healthcare of Atlanta for follow-up \n\n Patients with a transplanted heart \n\n no informed consent", - "brief_summary": "Pacemakers can be attached to one or more than one of the heart chambers. After watching pacemakers work over time, doctors have found that the pacemakers that stimulate only one chamber of the heart sometimes lead to problems later. These problems may be changes in the size and shape of the heart. The heart cannot work as well when some of these changes happen. We need to learn more about these changes and how to prevent them. There has not been an easy way to do this. A new treatment called Cardiac Resynchronization Therapy (CRT) is associated with biventricular pacing where two chambers of the heart are stimulated simultaneously. Tissue Doppler Imaging,Tissue Synchronization Imaging and 3 dimensional echocardiography are new forms of technology that look at the heart while it works. They are similar to a moving x-ray that can watch the heart muscles moving. The movement can be measured. Doctors will check for changes that happen over time. This has not been studied in children before because this kind of is new to this group of patients. This technology is noninvasive which means it can be done from the outside of the body and is painless.~The hearts of children grow fast. It is important to be able to know if the pacemaker or problems from dilated cardiomyopathy are causing any changes in the heart that might cause problems. We expect to be able to use information we learn from this study to improve how we use pacemakers in the future to avoid problems that can happen over time.", - "NCTID": "NCT00208806" - } - ], - "2": [ - { - "brief_title": "Biomarkers to Classify Heart Failure", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "511.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients admitted with symptomatic heart failure, diagnosed within 2 years. \n\n Diagnosis of congestive heart failure using the modified Framingham criteria: \n\n Simultaneous presence of at least 2 major criteria or 1 major criterion in conjunction with 2 minor criteria or a previous clear diagnosis of heart failure. \n\n Major criteria: \n\n Paroxysmal nocturnal dyspnea or orthopnea \n\n Neck vein distention \n\n Rales/Crackles (>10 cm from base of lungs) \n\n Acute pulmonary edema \n\n S3 gallop \n\n Increased central venous pressure (>16 cm H2O at right atrium) \n\n Hepatojugular reflux \n\n Weight loss >4.5 kg in 5 days in response to treatment Echocardiographic left ventricular dysfunction \n\n Minor criteria: \n\n Bilateral ankle edema \n\n Nocturnal cough \n\n Dyspnea on exertion \n\n Hepatomegaly \n\n Pleural effusion \n\n Weight loss >4.5 kg caused by heart failure where factors other than treatment of CHF could have contributed to the weight loss \n\n Tachycardia (heart rate >120 beats/min) Minor criteria are acceptable only if they cannot be attributed to another medical condition (such as pulmonary hypertension, chronic lung disease, cirrhosis, ascites, or the nephrotic syndrome). \n\n ", - "exclusion_criteria": ": \n\n Patients unable to provide blood sample \n\n Patients unable to provide consent \n\n Patient with life expectancy of less than 6 months, or has major co-morbidities. \n\n Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. \n\n Participants who have participated in another research trial involving an investigational product in the past 30 days.", - "brief_summary": "The purpose of this study is to evaluate existing biomarkers and see if they can be used to accurately diagnose the etiology of heart failure.", - "NCTID": "NCT02347722" - }, - { - "brief_title": "Kyoto Congestive Heart Failure Study", - "phase": "", - "drugs": "['Standard']", - "drugs_list": [ - "Standard" - ], - "diseases": "['Congestive Heart Failure', 'Heart Failure, Diastolic', 'Heart Failure, Systolic', 'Elderly Frail', 'Guideline Adherence']", - "diseases_list": [ - "Congestive Heart Failure", - "Heart Failure", - "Diastolic", - "Heart Failure", - "Systolic", - "Elderly Frail", - "Guideline Adherence" - ], - "enrollment": "4056.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients who admitted to the participating centers due to acutly decompensated CHF defined by modified Framingham criteria \n\n Patients who underwent heart failure treatment including intravenus drug \n\n ", - "exclusion_criteria": ": \n\n none", - "brief_summary": "The purpose of this study is to investigate the patient characteristics, selection of treatment, and factors associated with clinical outcomes in Japanese patients with acutely decompensated congestive heart failure.", - "NCTID": "NCT02334891" - }, - { - "brief_title": "Effect of Post Discharge Follow-up on Readmission Rates for Congestive Heart Failure Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Congestive Heart Failure', 'Systolic Dysfunction']", - "diseases_list": [ - "Congestive Heart Failure", - "Systolic Dysfunction" - ], - "enrollment": "21.0", - "inclusion_criteria": "inclusion criteria: \n\n Age =/or >18 \n\n Admitted to the Heart Failure Unit with acute decompensated heart failure \n\n Referred to the Congestive Heart Failure Disease Management Program \n\n ", - "exclusion_criteria": ": \n\n Age<18 \n\n Mentally incapacitated \n\n Discharge to a skilled nursing facility", - "brief_summary": "The purpose of this study is to test the hypothesis that a comprehensive post-discharge disease management system is more effective in reducing the readmission rate for heart failure patients compared to standard care.", - "NCTID": "NCT01529463" - }, - { - "brief_title": "Heart Failure Registry", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Heart Failure, Congestive']", - "diseases_list": [ - "Heart Failure", - "Congestive" - ], - "enrollment": "150000.0", - "inclusion_criteria": "inclusion criteria: \n\n Received or is eligible to receive a principal hospital discharge diagnosis of HF or decompensated HF is present as determined clinically by the patient care team \n\n ", - "exclusion_criteria": ": \n\n Heart Failure is present as a co-morbid condition, but is not a principal focus of diagnosis or treatment during this hospitalization episode", - "brief_summary": "The purpose of this registry is to compile a large clinical database on the medical management of patients hospitalized with acute heart failure, using information collected from acute care hospitals across the United States.", - "NCTID": "NCT00530426" - }, - { - "brief_title": "A Study Comparing Blood Flow and Clinical and Safety Effects of the Addition of Natrecor (Nesiritide), Placebo or Intravenous Nitroglycerin to Standard Care for the Treatment of Worsening Congestive Heart Failure.", - "phase": "Phase 3", - "drugs": "['nesiritide']", - "drugs_list": [ - "nesiritide" - ], - "diseases": "['Symptomatic Decompensated Congestive Heart Failure', 'Congestive Heart Failure in Acute Coronary Syndrome']", - "diseases_list": [ - "Symptomatic Decompensated Congestive Heart Failure", - "Congestive Heart Failure in Acute Coronary Syndrome" - ], - "enrollment": "498.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with dyspnea (difficulty breathing and shortness of breath) at rest, while supine, or immediately upon minimal activity such as talking, eating, or bathing \n\n having evidence of heart disease, rather than pulmonary disease, as the primary cause for the dyspnea (by demonstrating at least two of the following: jugular venous distension, paroxysmal nocturnal dyspnea or 2-pillow orthopnea within 72 hours before the start of study drug, abdominal discomfort due to hepatosplanchnic congestion, chest x-ray with findings indicative of heart failure) \n\n having elevated cardiac filling pressures either by clinical estimate in non-catheterized patients, or a measured pulmonary capillary wedge pressure (PCWP) >= 20 mm Hg in catheterized patients \n\n requiring hospitalization and intravenous therapy for at least 24 hours for the treatment of acutely decompensated heart failure. \n\n ", - "exclusion_criteria": ": \n\n NPatients having systolic blood pressure consistently less than 90 mm Hg \n\n having cardiogenic shock (a sudden decrease in blood pressure that results in decreased perfusion of body tissues and organs), volume depletion, or any other clinical condition that would contraindicate the administration of an intravenous agent with potent vasodilating properties \n\n having their most recent pulmonary capillary wedge pressure (PCWP) < 20 mm Hg within 24 hours before randomization \n\n having a clinical status so acutely unstable that the potential subject could not tolerate placement of a right heart catheter or the 3-hour placebo period \n\n unable to have intravenous nitroglycerin withheld (e.g., intravenous nitroglycerin for management of an acute coronary syndrome).", - "brief_summary": "The purpose of this study is to compare the hemodynamic (blood flow) and clinical effects of the study drug, Natrecor (nesiritide, a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure) to those of intravenous nitroglycerin or placebo, when added to the standard care therapy that is usually administered in the treatment of patients with worsening congestive heart failure.", - "NCTID": "NCT00270374" - }, - { - "brief_title": "Gulf Acute Heart Failure Registry", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Acute Heart Failure']", - "diseases_list": [ - "Acute Heart Failure" - ], - "enrollment": "5005.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of acute heart failure \n\n Admitted to the participating hospitals \n\n ", - "exclusion_criteria": ": \n\n Patients with acute heart failure who are discharged from the emergency room without admission. \n\n Patients transferred from non-registry hospital \n\n Failure to obtain informed consent", - "brief_summary": "The Gulf Heart Association (GHA) sponsored Gulf acute heart failure registry (Gulf CARE)is a multinational , multicentre, prospective, observational, hospital-based registry of patients with acute heart failure(AHF) with 3 month and one year follow-up.~Study Hypothesis: Due to variations in age at presentation, risk factors for heart failure particularly high prevalence of rheumatic heart disease in certain Gulf countries, variable medical practices and heart failure management setup in the Gulf region, AHF patients in the Gulf states are expected to have different presentation and receive different management than patients in European countries resulting in different outcome. It is also hypothesized that there is considerable gap between heart failure management guidelines and clinical practices in the Gulf region.", - "NCTID": "NCT01467973" - }, - { - "brief_title": "Nutritional Evaluation of Patients With Congestive Heart Failure", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Congestive Heart Failure']", - "diseases_list": [ - "Congestive Heart Failure" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Congestive heart failure patients between tne ages 40 to 90,all stages of the disease. \n\n ", - "exclusion_criteria": ": \n\n non", - "brief_summary": "This study objective is to assess the nutritional status of Patients With Congestive Heart Failure.", - "NCTID": "NCT01977404" - }, - { - "brief_title": "Optimising Congestive Heart Failure Outpatient Clinic Project", - "phase": "", - "drugs": "['Nurse monitored heart failure program', 'Standard primary health care']", - "drugs_list": [ - "Nurse monitored heart failure program", - "Standard primary health care" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "208.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients 60 years of age or older \n\n Hospitalized with heart failure according to New York Heart Association (NYHA) class II-IV \n\n Left ventricular systolic dysfunction with an ejection fraction below 0.45, by echocardiography \n\n ", - "exclusion_criteria": ": \n\n An acute myocardial infarction or unstable angina pectoris within the last three months \n\n Valvular stenosis \n\n Dementia \n\n Severe concomitant disease \n\n Refusal to participate.", - "brief_summary": "This study examines whether a nurse monitored management program at the hospital heart failure outpatient clinic can improve quality of life in elderly patients with chronic heart failure, as compared to standard treatment in primary healthcare.", - "NCTID": "NCT01671995" - }, - { - "brief_title": "Beta-Blocker Continuation Versus Interruption in Heart Failure Worsening", - "phase": "Phase 4", - "drugs": "['beta-blocker treatment']", - "drugs_list": [ - "beta-blocker treatment" - ], - "diseases": "['Heart Failure, Congestive']", - "diseases_list": [ - "Heart Failure", - "Congestive" - ], - "enrollment": "180.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with heart failure treated with beta-blocker; hospitalisation for heart failure worsening with pulmonary oedema. \n\n Left ventricular ejection fraction less than 40% \n\n ", - "exclusion_criteria": ": \n\n Indication of intravenous positive inotropic treatment \n\n Indication to withdraw beta-blocker treatment", - "brief_summary": "The objective of the B-Convinced study is to demonstrate the non-inferiority of beta-blocker continuation compared to its interruption in patients with congestive heart failure who are treated by a beta-blocker and present with an episode of heart failure worsening with pulmonary oedema requiring hospital admission.~162 patients will be randomized in cardiology centers in France. Clinical status (primary endpoint) will be evaluated with a standardized questionnaire 3 days after hospital admission.", - "NCTID": "NCT00162565" - }, - { - "brief_title": "Assessment of Coronary Flow Reserve in Heart Failure Patients After Ultrafiltration Versus Diuretics", - "phase": "", - "drugs": "['Loop diuretics (furosemide, torsemide, bumetanide)', 'Ultrafiltration']", - "drugs_list": [ - "Loop diuretics (furosemide", - "torsemide", - "bumetanide)", - "Ultrafiltration" - ], - "diseases": "['Acute Decompensated Heart Failure']", - "diseases_list": [ - "Acute Decompensated Heart Failure" - ], - "enrollment": "4.0", - "inclusion_criteria": "inclusion criteria: \n\n males and non-pregnant female patients over 18 years admitted to the hospital or treated in an outpatient heart failure clinic with the primary diagnosis of acute decompensated heart failure. \n\n evidence of fluid overload more than 8 kg above their dry weight, and conforming to definition of hypervolemia (at least two of the following findings: more than 1+ pitting edema of the lower extremities, jugular venous pressure more than 10 cm water, pulmonary edema or pleural effusion on chest radiograph consistent with ADHF, ascites, paroxysmal nocturnal dyspnea, or equal or more than 2 pillow orthopnea. \n\n ", - "exclusion_criteria": ": \n\n acute coronary syndrome \n\n documented ischemic cardiomyopathy \n\n atrial fibrillation \n\n serum creatinine more than 3.0 mg/dL \n\n systolic blood pressure less than 90 mmHg \n\n hematocrit > 45% \n\n clinical instability likely to require intravenous vasopressors and/or intravenous vasoactive drugs (such as milrinone, dobutamine, nitroglycerin or nesiritide) during the present hospitalization \n\n severe pulmonary hypertension or use of pulmonary hypertension drugs (such as sildenafil, bosentan or other endothelin inhibitors) \n\n patients with documented hypertrophic obstructive cardiomyopathy or restrictive cardiomyopathy, \n\n patients with severe valvular heart disease, \n\n patients with recent cocaine use (within one month of presentation) \n\n patients with heart transplant \n\n patients with systemic infection \n\n patients on hemodialysis \n\n inability to obtain venous access \n\n contraindications for anticoagulation \n\n unable to lie flat for at least 20 minutes \n\n pregnant and breast-feeding women.", - "brief_summary": "The purpose of this research study is to compare the effects (good and bad) of ultrafiltration treatment with standard intravenous (in your vein) diuretic therapy (furosemide, torsemide, bumetanide) on your heart function and blood flow.", - "NCTID": "NCT01457053" - }, - { - "brief_title": "Organized Program To Initiate Lifesaving Treatment In Hospitalized Patients With Heart Failure (OPTIMIZE-HF)", - "phase": "Phase 4", - "drugs": "['Beta-blockers including Carvedilol', 'ACE inhibitors']", - "drugs_list": [ - "Beta-blockers including Carvedilol", - "ACE inhibitors" - ], - "diseases": "['Heart Failure, Congestive']", - "diseases_list": [ - "Heart Failure", - "Congestive" - ], - "enrollment": "50000.0", - "inclusion_criteria": "inclusion criteria: \n\n Hospitalized for episode of worsening heart failure as primary cause of admission or significant heart failure symptoms that develop during the hospitalization when the initial reason for admission was not heart failure. \n\n Systolic dysfunction (LVEF < 40%) or heart failure symptoms in the setting of preserved systolic function (diastolic dysfunction). \n\n ", - "exclusion_criteria": ": \n\n This study has no ", - "brief_summary": "This program is designed to improve medical care and education of hospitalized patients with heart failure and accelerate the initiation of evidence-based heart failure guideline recommended therapies by administering them before hospital discharge. A registry component focusing on admission to discharge and 60- to 90-day follow-up is designed to evaluate the demographic, pathophysiologic, clinical, treatment, and outcome characteristics of patients hospitalized with heart failure.", - "NCTID": "NCT00344513" - }, - { - "brief_title": "Cardiorenal Interactions During Treatment of Acute Decompensated Heart Failure: Diuretics Versus Ultrafiltration", - "phase": "Phase 3", - "drugs": "['ultrafiltration', 'diuretics']", - "drugs_list": [ - "ultrafiltration", - "diuretics" - ], - "diseases": "['Acute Decompensated Heart Failure']", - "diseases_list": [ - "Acute Decompensated Heart Failure" - ], - "enrollment": "1.0", - "inclusion_criteria": "inclusion criteria: \n\n >18 years old \n\n Severe systolic heart failure with ejection fraction <40% \n\n And Hospitalisation for decompensated heart failure \n\n And New York Heart Association (NYHA) III or IV \n\n And 1 of the following: \n\n Jugular vein distension>6cm \n\n Tissue Doppler mitral annulus lateral>12 or medial>15 \n\n Chest X-ray: pulmonary edema or pleural effusion \n\n ", - "exclusion_criteria": ": \n\n Need for inotropic or vasopressive agents \n\n Use of intravenous (IV) contrast media \n\n Acute coronary syndrome \n\n Need of dialysis \n\n Severe co-morbidity \n\n Contra-indications for anticoagulation \n\n Pregnancy", - "brief_summary": "The CRUF trial is a prospective randomized monocentric trial comparing different impact of diuretics versus ultrafiltration on renal congestion, plasma refill rate, echocardiographic filling pressures, neurohormonal activation and biomarkers of Acute Kidney Injury (AKI).", - "NCTID": "NCT01138683" - }, - { - "brief_title": "Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure (MELT-HF)--A Single Center Pilot Study.", - "phase": "Phase 3", - "drugs": "['Experimental: Placebo', 'Experimental: Metolazone']", - "drugs_list": [ - "Experimental: Placebo", - "Experimental: Metolazone" - ], - "diseases": "['Acute Decompensated Heart Failure']", - "diseases_list": [ - "Acute Decompensated Heart Failure" - ], - "enrollment": "147.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 years or older \n\n Current hospitalization for chronic congestive heart failure with admission up to 48 hours prior to inclusion. \n\n Chronic heart failure will be defined as requiring treatment for a minimum of 30 days prior to current admission, NYHA Class III or IV at the time of hospitalization, and left ventricular ejection fraction less than 40% within one year or evidence of heart failure with preserved ejection fraction and evidence of diastolic dysfunction on echocardiogram. \n\n Admitted with clinical decompensated heart failure based on history, physical exam, and parameters indicating extracellular volume expansion such as including JVP \u2265 8 cm of water and 1+ or greater peripheral edema \n\n Is able to be dosed with study medication within six (6) hours of first dose of IV diuretics \n\n ", - "exclusion_criteria": ": \n\n Baseline severe hypotension (Mean arterial pressure < 55 mm Hg) \n\n Creatinine clearance less than 20 ml/min or creatinine greater than 2.5 mg/dl. \n\n Serum sodium less than 128 meq/L. \n\n Serum Potassium < 3.0 meq/L. \n\n Known adverse reaction to metolazone \n\n Inability to take oral medications \n\n Severe Aortic Stenosis (AVA < 0.8cm2) \n\n History of Hypertrophic obstructive cardiomyopathy \n\n Metastatic Carcinoma per history \n\n Severe COPD, FEV < 1L \n\n Severe dyspnea requiring prolonged CPAP,BIPAP or intubation", - "brief_summary": "The primary objective of the study is to determine efficacy of metolazone as synergistic therapy with Lasix in patients with acute decompensated heart failure. This will be a single center double blinded randomized placebo- controlled pilot study of the addition of 5 mg of metolazone per day for 2 days compared to placebo in patients admitted with acute decompensated heart failure.", - "NCTID": "NCT02620384" - }, - { - "brief_title": "Medication Adherence Telemonitoring to Reduce Heart Failure Readmissions", - "phase": "", - "drugs": "['Medication adherence telemonitoring']", - "drugs_list": [ - "Medication adherence telemonitoring" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Hospitalized for heart failure \n\n Prescribed loop diuretic medication at discharge \n\n ", - "exclusion_criteria": ": \n\n Age less than 21 years \n\n New York Heart Association Class IV heart failure \n\n Terminal illness (<6 mo prognosis) \n\n Unable to self-administer medications due to mental illness or cognitive impairment \n\n Non-English/Spanish speaking \n\n Discharged to an institutional setting (e.g., nursing home) \n\n Cardiologist or primary care provider refusal \n\n Unavailable for follow-up \n\n No access to telephone \n\n Enrolled in another cardiac trial", - "brief_summary": "The overall purpose of this project is to determine the feasibility of conducting a large scale randomized clinical trial that compares remote monitoring of adherence to loop diuretics using a wireless electronic pillcap with usual care among recently hospitalized heart failure patients. The long-term goal of this program of research is to determine the effect of the adherence telemonitoring intervention on medication adherence and hospital readmissions among recently hospitalized heart failure patients.", - "NCTID": "NCT02378571" - }, - { - "brief_title": "Left Atrial Distensibility Guiding Management in Advanced Chronic Heart Failure", - "phase": "", - "drugs": "['left atrial distensibility-guiding prescription of heart failure drugs']", - "drugs_list": [ - "left atrial distensibility-guiding prescription of heart failure drugs" - ], - "diseases": "['Chronic Heart Failure']", - "diseases_list": [ - "Chronic Heart Failure" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Advanced chronic heart failure (HF) will be defined as left ventricular ejection fraction less than 35%, creatinine less than 2 mg/dL, and CHF NY functional class III-IV for more than 3 months. Enrolled patients should be admitted to hospital due to heart failure requiring adjustment of inotropic agents or diuretics within recent 6 months. \n\n ", - "exclusion_criteria": ": \n\n presence of mitral stenosis or prosthetic mitral valve \n\n any abnormality of atrial septum (e.g., atrial septal defect or aneurysm) \n\n inadequate image quality \n\n lack of informed consent", - "brief_summary": "Background and Purpose- According to our prior studies, left atrial (LA) distensibility was associated significantly with left ventricular filling pressure in patients with acute myocardial infarction (AMI), chronic stable angina, and severe mitral regurgitation. LA distensibility can be used as noninvasive Swan-Ganz catheter. Additionally, it could predict in-hospital mortality in AMI patients. In the current study, left atrial distensibility guiding management in advanced chronic heart failure will be performed to assess whether those management could influence long-term prognosis including mortality rate, rehospitalization rate and the duration of rehospitalization.~Materials and Methods- Advanced chronic heart failure (HF) is defined as left ventricular ejection fraction less than 35%, creatinine less than 2 mg/dL, and CHF NY functional class III-IV for more than 3 months. Enrolled patients should be admitted to hospital due to heart failure requiring adjustment of inotropic agents or diuretics within recent 6 months. Three hundred HF cases will be recruited - 100 with sinus rhythm, and 100 with atrial fibrillation served as LA distensibility guided treatment group (guide group) and another 100 patients, either sinus rhythm or atrial fibrillation, served as control group. The management of guide group will be adjusted by LA distensibility, including the dose of inotropic agents, diuretics, beta-blocker, ACEI, and AIIB. Initially, the guide group will be followed 1 time per 2 week at first 3 months, then 1 time per month later. The control group will be treated by conventional management and traditional echocardiography can be performed as in-charge doctor request. The necessity of hospitalization for heart failure will be adjusted by 2 cardiovascular specialists and all patients admitted for heart failure will be managed by the same one cardiovascular specialist (Shih-Hung Hsiao). The total duration of follow-up will be 2 years. For life-threatening heart failure, intravenous nitroprusside drip under continuous A-line monitor, percutaneous coronary intervention, Swan-Ganz catheter insertion, intra-aortic balloon pump, and ECMO can be done according to the order of in-charge doctor. The primary end-point will be all-cause mortality. The second end-points will be heart failure with hospitalization and the duration of each hospitalization. Additionally, the ratios of medication changes in 2-year follow-up, including diuretics, inotropic agents, beta blockers, ACEI, and AIIB, will be assessed. Analysis will also be performed to estimate the trends of heart function (either systolic or diastolic) and renal function during 2-year follow-up according to whether guiding by LA distensibility is done or not.", - "NCTID": "NCT01307722" - }, - { - "brief_title": "Cognition and Exercise Training", - "phase": "", - "drugs": "['high intensity interval training (HIIT)', 'moderate intensity continuous exercise training']", - "drugs_list": [ - "high intensity interval training (HIIT)", - "moderate intensity continuous exercise training" - ], - "diseases": "['Metabolic Syndrome', 'Coronary Heart Disease', 'Chronic Heart Failure']", - "diseases_list": [ - "Metabolic Syndrome", - "Coronary Heart Disease", - "Chronic Heart Failure" - ], - "enrollment": "6.0", - "inclusion_criteria": "inclusion criteria: \n\n Elderly healthy subjects : with no MetS and no-documented CHD, both males and females, aged>60 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. \n\n Patients with metabolic syndrome and no-documented CHD, both males and females, aged > 18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. MetS will be defined according to recent updated criteria: presence of at least three of five criteria, namely abdominal obesity (waist circumference cut-off depending on the recently published ethnic-based variations, triglycerides > 1.70 mmol/l, decreased HDL-cholesterol (< 1.0 mmol/l in men and < 1.3 mmol/l in women), systolic blood pressure > 130 mmHg or diastolic blood pressure > 85 mmHg, and FPG > 5.6 mmol/l. \n\n CHD patients, both males and females, aged > 18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. Moreover, they must have documented CHD (prior myocardial infarction, prior coronary angiography or angioplasty, or documented myocardial ischemia on myocardial scintigraphy). \n\n Patients with documented stable chronic heart failure will be recruited if they show the following inclusion criteria: \n\n \u226518 years \n\n Left ventricular ejection fraction (LVEF) <40% (measured within 6 months of their enrolment by MUGA Scan, echo or radiological ventriculography) \n\n NYHA functional class I-III \n\n Optimal therapy at stable doses including a beta-blocker and an ACE inhibitor or ARA for at least 6 weeks prior to investigation (unless documented rationale for variation). \n\n Able to perform an symptom limited exercise test. \n\n Capacity and willingness to sign the informed consent form. \n\n ", - "exclusion_criteria": ": \n\n For healthy elderly subjects: \n\n age under 60 years \n\n lack of expressed written consent \n\n metabolic syndrome \n\n coronary heart disease \n\n chronic systolic heart failure \n\n resting left ventricular ejection fraction < 40 % \n\n symptomatic aortic stenosis \n\n chronic atrial fibrillation \n\n malignant exertional arrhythmias \n\n non-cardiopulmonary limitation to exercise (e.g: arthritis or claudication) \n\n severe exercise intolerance. \n\n For patients with metabolic syndrome: \n\n lack of expressed written consent \n\n coronary heart disease \n\n chronic systolic heart failure \n\n resting left ventricular ejection fraction < 40 % \n\n symptomatic aortic stenosis \n\n chronic atrial fibrillation \n\n malignant exertional arrhythmias \n\n non-cardiopulmonary limitation to exercise (e.g: arthritis or claudication) \n\n severe exercise intolerance. \n\n For patients with CHD \n\n lack of expressed written consent \n\n recent acute coronary event (< 3 months) \n\n chronic systolic heart failure \n\n resting left ventricular ejection fraction < 40 % \n\n symptomatic aortic stenosis \n\n severe non-revascularize coronary disease including left main coronary stenosis \n\n patient awaiting coronary artery bypass surgery \n\n chronic atrial fibrillation \n\n presence of permanent ventricular pacemaker \n\n malignant exertional arrhythmias \n\n non-cardiopulmonary limitation to exercise (e.g: arthritis or claudication) \n\n severe exercise intolerance. \n\n For CHF patients: \n\n Any relative or absolute contraindications to exercise training among patients with stable chronic heart failure according to current recommendations (Working Group on Cardiac Rehabilitation 2001) \n\n Fixed-rate pacemaker or ICD devices with heart rate limits set lower than the exercise training target heart rate. \n\n Major cardiovascular event of procedure within the 3 months preceding enrolment in the study. \n\n Atrial fibrillation \n\n Heart failure secondary to significant uncorrected primary valvular disease (except for mitral regurgitation secondary to LV dysfunction) \n\n Heart failure secondary to congenital heart disease or obstructive cardiomyopathy.", - "brief_summary": "The aim of study is to investigate the impact of two different training modalities (high intensity interval training (HIIT) versus moderate intensity continuous exercise training (MICET) on cognitive performance, cerebral oxygenation, cardiac output and physical fitness in older healthy adults, patients with metabolic syndrome, coronary heart disease and heart failure. The investigators hypothesized that HIIT modality will lead to a larger improvement in physical fitness (i.e. VO2peak), cardiovascular parameters (cardiac output and stroke volume) and cognitive performance at rest and during submaximal exercise. The primary endpoint will be the improvement in cognitive performance.", - "NCTID": "NCT01906957" - }, - { - "brief_title": "Pilot Study: Hypovitaminosis D, Hyperparathyroidism and Hypomagnesemia in Patients With Congestive Heart Failure", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Congestive Heart Failure', 'Hypovitaminosis D', 'Hyperparathyroidism']", - "diseases_list": [ - "Congestive Heart Failure", - "Hypovitaminosis D", - "Hyperparathyroidism" - ], - "enrollment": "48.0", - "inclusion_criteria": "inclusion criteria: \n\n congestive heart failure \n\n ", - "exclusion_criteria": ": \n\n pregnant \n\n hospitalized within one month \n\n taking calcium, vitamin D or magnesium supplements \n\n proteinuria > 1g/24h \n\n creatinine clearance <35 (MDRD)", - "brief_summary": "People with heart failure may have low magnesium and low vitamin D levels. They may also have abnormally high levels of parathyroid hormones. Magnesium and vitamin D are important chemicals that are not routinely measured in blood tests. We are studying how many people with heart failure have low levels of magnesium and vitamin D. We are also studying how many people with heart failure have overactive parathyroid glands and if that is related to their vitamin D levels.", - "NCTID": "NCT00887666" - }, - { - "brief_title": "Role of USCOM in Adult Patients With Heart Failure", - "phase": "", - "drugs": "['Ultrasonic cardiac output monitor', 'Echocardiography']", - "drugs_list": [ - "Ultrasonic cardiac output monitor", - "Echocardiography" - ], - "diseases": "['Acute Decompensated Heart Failure', 'Congestive Heart Failure Compensated']", - "diseases_list": [ - "Acute Decompensated Heart Failure", - "Congestive Heart Failure Compensated" - ], - "enrollment": "242.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 18 years, AND \n\n Written informed consent by patient or nearest relative where appropriate, AND Either \n\n Referred for echocardiography, OR \n\n At least one typical symptom and one typical sign consistent with possible heart failure, OR \n\n Healthy volunteers \n\n ", - "exclusion_criteria": ": \n\n Age <18 years \n\n Prior enrollment in study \n\n Patients with known or suspected pregnancy", - "brief_summary": "Objective:~The Ultrasonic Cardiac Output Monitor (USCOM) is a non-invasive, quantitative method for measuring and monitoring cardiovascular haemodynamic parameters in patients. The aims of this study are:~To investigate whether USCOM-derived haemodynamic parameters such as Cardiac output (CO), inotropy and oxygen delivery (DO2) have a role in the diagnosis of patients with a compensated heart failure syndrome (cHFS) or acute decompensated heart failure syndrome (adHFS)~To investigate whether USCOM-derived haemodynamic parameters such as CO, inotropy and DO2 correlate with heart failure staging, especially New York Heart Association (NYHA) class and American Heart Association (AHA) stage.~To investigate whether USCOM-derived haemodynamic parameters such as velocity time interval (vti), stroke volume (SV), CO, SV index (SVI), CO index (CI), inotropy and DO2 correlate with ejection fraction.~To investigate whether USCOM-derived haemodynamic variables may be used as prognostic indicators of 30-day, 6-month and 1-year Major Adverse Cardiac Events (MACE).~To evaluate the agreement between hemodynamic measurements obtained using the Ultrasonic Cardiac Output Monitor (USCOM\u00ae; USCOM Ltd., Sydney, Australia), and reference standards as determined by 2 Dimensional echocardiography (2D-echo) measurements in groups of haemodynamically stable and unstable adult patients.~Design:~This prospective observational cohort study will be conducted in the Prince of Wales Hospital in Hong Kong.~Setting and Subjects:~Patients will be screened and recruited from adult patients either scheduled for elective 2D-echo at a cardiology clinic at the Prince of Wales Hospital, or attending the emergency department at the Prince of Wales Hospital.~Interventions:~Haemodynamic measurements made using the USCOM and 2D-echo will be compared. In order to assess inter-observer variability, a second, blinded operator will repeated 15% of scans.", - "NCTID": "NCT02289508" - }, - { - "brief_title": "Nurse-Led Heart Failure Care Transition Intervention for African Americans: The Navigator Program", - "phase": "", - "drugs": "['Heart Failure Self Care Support', 'Usual heart failure care']", - "drugs_list": [ - "Heart Failure Self Care Support", - "Usual heart failure care" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "11.0", - "inclusion_criteria": "inclusion criteria: \n\n hospitalized with admitting diagnosis of heart failure in prior 8 weeks \n\n self-identified as African American \n\n community-dwelling (i.e., not in a long-term care facility) \n\n residence within a predefined radius in Baltimore City \n\n working telephone in their home \n\n provide signed informed consent \n\n ", - "exclusion_criteria": ": \n\n cannot speak or understand English \n\n severe renal insufficiency requiring dialysis \n\n acute myocardial infarction within preceding 30 days \n\n receiving home care services for HF post discharge \n\n legally blind or have major hearing loss \n\n screen positive for cognitive impairment on the Mini-cog at baseline \n\n unable to stand independently on a weight scale (limited ability to participate in HAT system) \n\n weigh more than 325 pounds (exceed scale capacity) \n\n serious or terminal condition such as psychosis or cancer (actively receiving chemo or radiation) \n\n pregnant", - "brief_summary": "Heart failure (HF) affects over 5 million Americans with HF morbidity reaching epidemic proportions. Annual rates of new and recurrent HF events including hospitalization and mortality are higher among African Americans. In this study, the investigators are testing an interdisciplinary model for heart failure care, with focus on enhancing self management and use of telehealth, which has significant potential to improve self management and outcomes.~The main purpose of this study is to learn how to help African Americans with heart failure care for themselves at home. We hope to find out if a team including a nurse and community health navigator using a computer telehealth device can help people with heart failure stay healthier. The team will help people with heart failure to manage their medication, monitor their symptoms and weigh themselves every day after they leave the hospital. The team will also help people with heart failure learn to solve problems that may keep them from following their treatment plan.", - "NCTID": "NCT01141907" - }, - { - "brief_title": "How the Elderly Live With Pain in Heart Failure", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "56.0", - "inclusion_criteria": "inclusion criteria: \n\n Men and women \u2265 60 years. \n\n Admission to hospital for worsening HF \n\n ", - "exclusion_criteria": ": \n\n History of uncontrolled hypertension. \n\n Severe valve disease. \n\n End-stage (Stage D) HF, including treatment with chronic ionotropic drugs or left ventricular assist device support. \n\n Advanced malignancy or other medical condition with life expectancy less than 2 years or undergoing active chemotherapy or radiation therapy. \n\n Advanced chronic kidney disease (CKD) defined as estimated glomerular filtration rate (GFR) < 20 mL/min/1.73 m2 based upon the Modification of Diet in Renal Disease (MDRD) study equation), or on chronic or intermittent dialysis or dialysis anticipated within the next 6 months. \n\n Chronic anemia with hemoglobin < 9 gm/dl for males, < 8 gm/dl for females or acute anemia requiring transfusion of 2 or more units of blood.", - "brief_summary": "The How the Elderly Live with Pain in Heart Failure (HELP-HF) study provides the opportunity to assess the complaints of pain in a cohort of HF patient admitted to Thomas Jefferson University Hospital (TJUH). Additional information on their existing co-morbid conditions, an inventory of their prescribed medications, and details regarding the type of treatment interventions (over the counter analgesia and other comfort practices) they report using will be collected.", - "NCTID": "NCT01794728" - }, - { - "brief_title": "CHF Management Using Telemedicine", - "phase": "", - "drugs": "['Telemedicine']", - "drugs_list": [ - "Telemedicine" - ], - "diseases": "['Congestive Heart Failure (CHF)']", - "diseases_list": [ - "Congestive Heart Failure (CHF)" - ], - "enrollment": "106.0", - "inclusion_criteria": "inclusion criteria: \n\n Physician diagnosed CHF \n\n Member of Kaiser Permanente Georgia", - "exclusion_criteria": "", - "brief_summary": "The overall objective of this study is to improve clinical outcomes and quality of life for congestive heart failure (CHF) patients by integrating a readily available, low cost technology - the telephone - into coordinated CHF care.", - "NCTID": "NCT00309764" - }, - { - "brief_title": "Plasma ExtrAcellular RNAs and Biomarkers of Heart FaiLure During Decongestion: PEARL-HF Study", - "phase": "", - "drugs": "['Monitoring on heart failure therapy']", - "drugs_list": [ - "Monitoring on heart failure therapy" - ], - "diseases": "['Congestive Heart Failure']", - "diseases_list": [ - "Congestive Heart Failure" - ], - "enrollment": "400.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 21 years of age \n\n Left ventricular ejection fraction \u2264 50% (at any time in the past) \n\n Symptomatic (NYHA class II-IV) heart failure (as diagnosed by clinician, radiographic images, or abnormal natriuretic peptide level) \n\n Hospital admission, Emergency Department visit, or outpatient diuretic escalation of therapy for destabilized HF at least once in the 6 months prior to enrollment \n\n ", - "exclusion_criteria": ": \n\n Severe renal insufficiency defined as serum creatinine > 2.5 mg/dl \n\n United Organ Network Sharing status 1B for heart transplantation (outpatient inotrope use, LV assist device) \n\n Inoperable aortic valvular heart disease \n\n Life expectancy <1 year due to causes other than HF such as advanced cancer \n\n Cardiac transplantation or revascularization indicated or expected within 6 months \n\n Severe obstructive or restrictive pulmonary disease, defined as a forced expiratory volume in 1 sec <1 L (when diagnosed as standard of care) \n\n Subject unable or unwilling to provide written informed consent \n\n Coronary revascularization (percutaneous coronary intervention or bypass surgery) within the previous 3 months", - "brief_summary": "The primary objective is to measure the association between extracellular RNA (ex-RNA) levels in plasma in patients receiving aggressive outpatient therapy for CHF with (1) cardiac remodeling and (2) cardiovascular events. The investigators will follow patients during standard medical therapy for CHF to assess changes in ex-RNA levels in the plasma, and how these are associated with cardiac remodeling (by cardiac imaging) and outcomes.", - "NCTID": "NCT02632656" - }, - { - "brief_title": "Efficacy and Cost Effectiveness of Relaxation and Response to CHF", - "phase": "", - "drugs": "['relaxation technique', 'educational program']", - "drugs_list": [ - "relaxation technique", - "educational program" - ], - "diseases": "['Chronic Heart Failure']", - "diseases_list": [ - "Chronic Heart Failure" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria: \n\n CHF diagnosis, NY stage 2 or 3 \n\n ", - "exclusion_criteria": ":", - "brief_summary": "Despite the development of significant pharmaceutical treatments, morbidity and mortality of chronic heart failure (CHF) patients remain high, patients\ufffd quality of life is poor, and their health care utilization is heavy. It is therefore important to find a cost effective non-pharmaceutical treatment to help CHF patients manage the disease. The relaxation response has been found to be effective in managing CHF-related conditions. With its favorable physiological changes, the relaxation response is likely to benefit CHF patients.", - "NCTID": "NCT00012818" - }, - { - "brief_title": "Trial of a Tailored Message Program to Implement CHF Guidelines", - "phase": "", - "drugs": "['CHF Self-management Education (Web-based Education)']", - "drugs_list": [ - "CHF Self-management Education (Web-based Education)" - ], - "diseases": "['Heart Failure']", - "diseases_list": [ - "Heart Failure" - ], - "enrollment": "700.0", - "inclusion_criteria": "inclusion criteria: \n\n EF <40%, getting majority care at the VA, not enrolled in another CHF study, ability to read English. \n\n ", - "exclusion_criteria": ":", - "brief_summary": "Congestive heart failure is a serious health problem in the United States and is associated with excessive morbidity and mortality. Several classes of medications have been shown to improve mortality in patients with CHF. Despite this these medications are widely under prescribed. Guidelines have been shown to improve patient outcomes and several guidelines on the management of CHF have been published. Implementation of guidelines is challenging and most strategies have focused on changing physician behavior. Patient-based interventions have been shown to be effective in implementing guidelines on CHF but they have been very labor intensive. A computer based intervention to implement CHF guidelines, if effective, would be beneficial.", - "NCTID": "NCT00013026" - }, - { - "brief_title": "A Morbidity-Mortality and Remodeling Study With Valsartan", - "phase": "Phase 4", - "drugs": "['valsartan']", - "drugs_list": [ - "valsartan" - ], - "diseases": "['Hypertension', 'Ischemic Heart Disease', 'Congestive Heart Failure']", - "diseases_list": [ - "Hypertension", - "Ischemic Heart Disease", - "Congestive Heart Failure" - ], - "enrollment": "3000.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of hypertension, ischemic heart disease and congestive heart failure \n\n ", - "exclusion_criteria": ": \n\n Pregnancy \n\n Severe renal damage \n\n Severe liver damage \n\n Acute myocardial infarction", - "brief_summary": "The JIKEI HEART Study has been designed to investigate whether concomitant treatment with valsartan, an angiotensin II receptor blocker (ARB), in addition to conventional treatment, will improve the prognosis of 3000 Japanese patients with cardiovascular diseases.", - "NCTID": "NCT00133328" - }, - { - "brief_title": "The Effect of CRT on the Hypercapnic Ventilatory Response", - "phase": "", - "drugs": "['CRT Implantation']", - "drugs_list": [ - "CRT Implantation" - ], - "diseases": "['Sleep Disordered Breathing', 'Heart Failure']", - "diseases_list": [ - "Sleep Disordered Breathing", - "Heart Failure" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Heart failure with reduced ejection fraction (<40%) \n\n Either no significant sleep disordered breathing or moderate to severe CSA \n\n Able to consent to the study \n\n Ambulatory \n\n Aged 18-100 years \n\n ", - "exclusion_criteria": ": \n\n Patients on Non-Invasive Ventilation \n\n Predominant OSA \n\n Unable to consent or attend for the study", - "brief_summary": "Central Sleep Apnoea (CSA) affects up to half of patients with severe heart failure and is associated with a poor prognosis. CSA is manifest as episodes of deep breathing interspersed with very shallow or absent breathing and is largely due to an exaggerated response to rising carbon dioxide in the blood, which normally drives how hard we breathe. Cardiac Resynchronization therapy (CRT), in which a pacemaker is implanted to improve co-ordinated contraction of the heart, has been shown to reduce the severity of CSA in some patient groups. We aim to determine whether this improvement is due to normalization of the body's response to carbon dioxide in the blood. Our hypothesis is that CRT improves CSA by normalizing the brain's response to carbon dioxide.", - "NCTID": "NCT02203383" - }, - { - "brief_title": "Utility of Serial BNP Levels in Emergency Department CHF", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Congestive Heart Failure']", - "diseases_list": [ - "Congestive Heart Failure" - ], - "enrollment": "52.0", - "inclusion_criteria": "inclusion criteria: \n\n age18 or older \n\n primary diagnosis of CHF in the Emergency Department \n\n admission to the hospital or transfer to the Observation Unit \n\n ", - "exclusion_criteria": ": \n\n minors, prisoners,pregnant women,unable to provide consent \n\n unstable angina or acute myocardial infarction in the ED \n\n dialysis dependent patients \n\n use of nesiritide as a therapy in the ED", - "brief_summary": "The purpose of the study is to determine if a series of BNP blood tests performed on patients who present to the Emergency Department with congestive heart failure (CHF) can predict which patients may have adverse outcomes. If the BNP is shown to be predictive of bad outcomes in certain patients, those patients might receive more intensive therapy early to prevent such outcomes. This was a prospective trial enrolling patients who presented to the ED and were diagnosed with heart failure. Subjects had a blood test for BNP, which is elevated in the presence of heart failure, collected twelve hours after their initial clinical BNP was obtained in the ED. Demographics, history, length of hospital stay, and other approved data were collected. At 30 days and 6 months after discharge, a follow up call was made to determine if the subject had required additional emergency care, had been admitted to a hospital, or had died during that period of time.", - "NCTID": "NCT00534066" - }, - { - "brief_title": "The Jackson Heart Study of Cardiovascular Disease Among African Americans", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cardiovascular Diseases', 'Heart Diseases', 'Atherosclerosis', 'Coronary Disease', 'Hypertension', 'Cerebrovascular Disorders']", - "diseases_list": [ - "Cardiovascular Diseases", - "Heart Diseases", - "Atherosclerosis", - "Coronary Disease", - "Hypertension", - "Cerebrovascular Disorders" - ], - "enrollment": "3000.0", - "inclusion_criteria": "inclusion criteria: \n\n African American \n\n Residents of Jackson, Mississippi \n\n ", - "exclusion_criteria": ": \n\n Institutionalization", - "brief_summary": "This is a prospective study of the environmental and genetic factors that influence the development of cardiovascular disease (CVD) in African American men and women. The cohort is a collaboration among multiple institutions (Jackson State University, Mississippi State Department of Health, Tougaloo College, and the University of Mississippi Medical Center), the National Institute on Minority Health and Health Disparities (NIMHD), and the National Heart, Lung, and Blood Institute (NHLBI).", - "NCTID": "NCT00005485" - } - ] - }, - { - "patient_id": "sigir-201519", - "patient": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", - "0": [ - { - "brief_title": "Epidemiology of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease (COPD)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Pulmonary Disease', 'Chronic Bronchitis']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease", - "Chronic Bronchitis" - ], - "enrollment": "976.0", - "inclusion_criteria": "inclusion criteria: \n\n 1. Written informed consent. 2. Age \u2265 40 years. 3. Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio (post-bronchodilator) <70%. 4. FEV1 (post-bronchodilator) < 80% of predicted. \n\n ", - "exclusion_criteria": ": \n\n 1. Moderate and severe exacerbations during the last 4 weeks. 2. Pregnancy. 3. Already participated in the study (allowed to participate only once).", - "brief_summary": "The purpose of this study was to investigate the prevalence of chronic bronchitis in patients suffering from moderate to very severe chronic obstructive pulmonary disease (COPD), and to assess the difference in exacerbation rates in patients suffering from moderate to very severe COPD with chronic bronchitis vs. a population of patients without chronic bronchitis.", - "NCTID": "NCT02128529" - }, - { - "brief_title": "Systemic Consequences and Comorbidities in Mild/Moderate Chronic Obstructive Pulmonary Disease (COPD), Time for Action!", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n age 40-80 years old \n\n cases: spirometry (post-bronchodilator) based diagnosis of COPD (GOLD criteria) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment. \n\n smoking controls: no COPD (spirometry based) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment. \n\n non-smoking controls: no COPD (spirometry based) + < 1 pack year \n\n ", - "exclusion_criteria": ": \n\n Respiratory disorder other than COPD \n\n \u03b11-antitrypsin deficiency \n\n Known history of significant inflammatory disease other than COPD \n\n COPD exacerbation within 4 weeks prior to study \n\n Lung surgery \n\n Recent diagnosis of cancer \n\n Therapy with oral corticosteroids in the last 6 weeks \n\n Significant cardiovascular comorbidity \n\n Significant orthopedic/musculoskeletal problems", - "brief_summary": "The aim of this prospective case-control study is to investigate the prevalence, severity and incidence of systemic consequences in newly detected patients with mild and moderate Chronic obstructive pulmonary disease (COPD). Special attention will be paid to skeletal muscle dysfunction and physical inactivity as these factors are, together with smoking, potentially modifiable.", - "NCTID": "NCT01314807" - }, - { - "brief_title": "Chronic Obstructive Pulmonary Disease (COPD) in Patients Hospitalized for Acute Decompensated Heart Failure.", - "phase": "", - "drugs": "['COPD']", - "drugs_list": [ - "COPD" - ], - "diseases": "['Disease']", - "diseases_list": [ - "Disease" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Heart failure \n\n ", - "exclusion_criteria": ": \n\n Ambulatory patients", - "brief_summary": "The presence of chronic obstructive pulmonary disease (COPD) would confer increased in-hospital mortality and length of hospital stay in patients with acute decompensated heart failure Assess the (1) prevalence of COPD in patients who are hospitalized for acute decompensated heart failure and (2) the association between COPD and in-hospital mortality or length of stay in this cohort.", - "NCTID": "NCT02340702" - }, - { - "brief_title": "A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore:", - "phase": "Phase 3", - "drugs": "['Roflumilast', 'Placebo', 'Salbutamol']", - "drugs_list": [ - "Roflumilast", - "Placebo", - "Salbutamol" - ], - "diseases": "['COPD']", - "diseases_list": [ - "COPD" - ], - "enrollment": "626.0", - "inclusion_criteria": "Main inclusion criteria: \n\n Willingness to sign a written informed consent \n\n Chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2009 \n\n Chinese or Malay or Indian ethnicity \n\n History of chronic obstructive pulmonary disease symptoms for at least 12 months prior to baseline visit V0 \n\n Forced expiratory volume in the first second/ Forced vital capacity (FEV1/FVC) ratio (post-bronchodilator) < 70% \n\n Forced expiratory volume in the first second (FEV1) (post-bronchodilator) < 50 % of predicted \n\n Former smoker (defined as: smoking cessation at least one year ago) or current smoker both with a smoking history of at least 10 pack years \n\n Main ", - "exclusion_criteria": ": \n\n Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics not stopped at V0 \n\n Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0 \n\n History of asthma diagnosis in patients < 40 years of age or relevant lung disease other than COPD \n\n Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0 \n\n Known alpha-1-antitrypsin deficiency", - "brief_summary": "The aim of this trial is to determine the efficacy, safety and tolerability of 500 \u00b5g Roflumilast tablets once daily in patients with COPD in China, Hong Kong, and Singapore.", - "NCTID": "NCT01313494" - }, - { - "brief_title": "Efficacy and Safety of 400 \u03bcg Twice Daily of Aclidinium Bromide vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)", - "phase": "Phase 3", - "drugs": "['aclidinium bromide 400 \u03bcg', 'aclidinium bromide placebo']", - "drugs_list": [ - "aclidinium bromide 400 \u03bcg", - "aclidinium bromide placebo" - ], - "diseases": "['COPD']", - "diseases_list": [ - "COPD" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n A diagnosis of stable moderate to severe COPD as defined by GOLD (the Global Initiative for Chronic Obstructive Lung Disease) guidelines(http://www.goldcopd.org); a postbronchodilator FEV1/forced vital capacity [FVC] ratio < 70% and FEV1 \u2265 30% to <80% of the predicted value. \n\n Current or former cigarette smokers with a smoking history of at least 10 pack-years. \n\n ", - "exclusion_criteria": ": \n\n History or current diagnosis of asthma \n\n Patients who have been hospitalized for an acute COPD exacerbation within 3 months prior to Visit 1 \n\n Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Visit 1. \n\n Patients with any clinically significant respiratory conditions other than COPD", - "brief_summary": "The purpose of this study was to observe the Efficacy and safety of 400 \u03bcg twice daily of aclidinium bromide vs. placebo when administered to patients with moderate to severe chronic obstructive pulmonary disease (COPD).", - "NCTID": "NCT01636401" - }, - { - "brief_title": "Biomarkers and Genetic Factors Related to Emphysema", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Emphysema', 'Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Emphysema", - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "145.0", - "inclusion_criteria": "inclusion criteria for All Participants: \n\n Able to read and write English \n\n At least 30 pack-year smoking history (the equivalent of smoking a pack a day for 30 years) \n\n Able to participate in the informed consent process \n\n Relatively stable clinical status for the past six weeks (i.e., no illness in the 6 weeks before study entry) \n\n inclusion criteria for Participants with Emphysema: \n\n Global Initiative for Chronic Obstructive Lung Disease (GOLD) class II, III, or IV COPD, as determined by post-bronchodilator spirometry values OR \n\n More than minimal emphysema on an acceptable-quality chest CT scan \n\n inclusion criteria for Participants without Emphysema: \n\n GOLD class I COPD or GOLD class 0 (2005 classification), as determined post-bronchodilator spirometry values AND \n\n No or minimal emphysema on an acceptable-quality chest CT scan \n\n ", - "exclusion_criteria": ": \n\n Pregnant \n\n Prisoner \n\n Vulnerable populations \n\n Recent illness (defined as increased cough, sputum production, worsening malaise, or need for unscheduled physician visit in the 6 weeks prior to enrollment) \n\n Coexisting active chronic inflammatory or collagen vascular disease, immunodeficiency of any kind, non-cutaneous malignancy (melanoma is an exclusion), or previous organ transplant \n\n Congenital abnormalities of the lung or previous lung surgery \n\n Known active hepatitis B, hepatitis C, or HIV/AIDS (not prospectively evaluated) \n\n CT evidence of lung disease other than emphysema (including significant fibrosis, bronchiectasis, consolidation, or indeterminate nodules)", - "brief_summary": "Emphysema, a common type of chronic obstructive pulmonary disease (COPD), is a long-term lung disease that is usually caused by cigarette smoking. This study will examine both current smokers and former smokers who have emphysema, as well as current and former smokers who do not have emphysema, to determine if certain factors found in the blood are related to the risk of developing emphysema.", - "NCTID": "NCT00757120" - }, - { - "brief_title": "The Natural History of Gene Expression in the Lung Cells of Non-Smokers, Smokers and Ex-Smokers in Health and Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Pulmonary Disease (COPD)', 'Smoking', 'Smoking Cessation', 'Chronic Bronchitis', 'Emphysema']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease (COPD)", - "Smoking", - "Smoking Cessation", - "Chronic Bronchitis", - "Emphysema" - ], - "enrollment": "171.0", - "inclusion_criteria": "inclusion criteria: \n\n Group A: Healthy nonsmokers \n\n All study individuals should be enrolled in the Airway protocol #1204012331 Collection of Airway, Blood and/or Urine Specimens from Subjects for Research Studies \n\n Willing and able to provide informed consent for the long term follow up study with repeated bronchoscopies \n\n Male and Female subject \u226518 years of age \n\n Never smokers is defined as someone who has smoked < 100 cigarettes per lifetime and whose urine nicotine <2 ng/mL and/or urine cotinine <5 ng/mL, at entry into the study \n\n Group B: Healthy current smokers Inclusion: \n\n All study individuals should be enrolled in the Airway protocol \n\n Willing and able to provide informed consent for the long term follow up study with repeated bronchoscopies \n\n Male and Female subject \u226518 years of age \n\n Active smoker as evidenced by self-report and urine nicotine >30 ng/mL and/or urine cotinine >50 ng/mL \n\n Group C: Healthy smokers who elect to stop smoking Inclusion: \n\n All study individuals should be enrolled in the Airway protocol \n\n Willing and able to provide informed consent for the long term follow up study with repeated bronchoscopies \n\n Male and Female subject \u226518 years of age \n\n Current smoker as evidenced by self-report and urine nicotine >30 ng/mL and/or urine cotinine >50 ng/mL \n\n Be a current smoker willing to stop smoking \n\n Group D - Current smokers with COPD Inclusion: \n\n All study subjects will be enrolled in the Airway protocol #1204012331 Collection of Airway, Blood and/or Urine Specimens from Subjects for Research Studies \n\n All study subjects should meet the lung disease criteria for having COPD may be of any stage (GOLD I - IV), be ambulatory and have no evidence of respiratory failure \n\n All study subjects should be able to provide informed consent for the long term follow up study with repeated bronchoscopies \n\n Male and Female subject \u226518 years of age \n\n Active smokers as evidenced by urine nicotine >30 ng/mL and/or urine cotinine >50 ng/mL \n\n Group E - Current smokers with COPD who elect to stop smoking Inclusion: \n\n All study subjects will be enrolled in the Airway protocol #1204012331 Collection of Airway, Blood and/or Urine Specimens from Subjects for Research Studies \n\n All study subjects should meet the lung disease criteria for having COPD may be of any stage (GOLD I - IV), be ambulatory and have no evidence of respiratory failure \n\n All study subjects should be able to provide informed consent for the long term follow up study with repeated bronchoscopies \n\n Male and Female subject \u226518 years of age \n\n Active smokers as evidenced by urine nicotine >30 ng/mL and/or urine cotinine >50 ng/mL \n\n Be a current smoker willing to stop smoking \n\n ", - "exclusion_criteria": ": \n\n Groups A - E \n\n Individuals unable to provide proper informed consent \n\n Habitual use of drugs and/or alcohol within the past six months (Acceptable: Marijuana one time in three months; average of two alcoholic beverages per day; drug and/or alcohol abuse is defined as per the DSM-IV Substance Abuse Criteria) \n\n Individuals with asthma and with recurrent or recent (within three months) and/or acute pulmonary infection \n\n Individuals with allergy to lidocaine \n\n Significant kidney disease or subjects on dialysis \n\n Females who are pregnant or lactating or intending to become pregnant in the next 12 months \n\n Subjects who are HIV positive \n\n Subjects that have unstable coronary artery disease as evidenced by unstable angina, >Class II New York Heart Association (NYHA) cardiac status, history of congestive heart failure or MI within the last 12 months \n\n Subjects who are contraindicated for undergoing bronchoscopy \n\n Subjects having any medical condition that in the opinion of the investigator would preclude the subject from entering the study \n\n Groups D and E \n\n - Subjects may not have evidence of respiratory failure such as SpO2 <90% or PaO2 <60 mmHg \n\n Groups C and E \n\n Current major depression or other significant psychiatric disorder \n\n Subjects currently taking anti-depressant medication", - "brief_summary": "Cigarette smoking is the major risk factor for chronic obstructive pulmonary disease (COPD, commonly known as chronic bronchitis and emphysema). Despite this clear link, only 15-20% of smokers develop COPD suggesting that genetic factors affect the lung's susceptibility to the stress of cigarette smoke. The cells lining the airways (epithelium) and cells that help defend the lung (alveolar macrophages) of smokers develop gene expression changes that are different from that of nonsmokers. In the investigators' previous studies they have demonstrated that there are greater than 200 genes that are responsive to cigarette smoke in these cells. But the investigators do not know whether the gene expression is static or changes as a function of time. Genes that show significant changes over time may be relevant to the progression of the disease. Even though quitting smoking reduces the rate at which the lungs decline, many-smokers still go on to develop COPD. This study will provide insights into the natural history of smoking-related gene expression of the lung cells in health and disease.", - "NCTID": "NCT00974064" - }, - { - "brief_title": "Protein Biomarker Discovery and Validation in Chronic Obstructive Pulmonary Disease (COPD) And Asthma", - "phase": "", - "drugs": "['Exhaled Breath Condensate (EBC)']", - "drugs_list": [ - "Exhaled Breath Condensate (EBC)" - ], - "diseases": "['Asthma', 'COPD']", - "diseases_list": [ - "Asthma", - "COPD" - ], - "enrollment": "9.0", - "inclusion_criteria": "inclusion criteria: \n\n Criteria for Asthma \n\n INCLUSION \n\n History consistent with asthma: episodic wheezing, shortness of breath, or cough \n\n Airway lability recognized by at least 12% improvement in Forced Expiratory Volume (FEV1) after 2 puffs of beta2 agonist Age >18yrs \n\n FEV1 >40% predicted \n\n Never smoker, current smoker, or quit smoking \u22655 years ago Criteria for COPD \n\n INCLUSION \n\n History consistent with COPD: dyspnea with exertion, productive cough, progressive course \n\n Smoking history of at least 20 pack years \n\n Current smoker or quit smoking \u22655 years ago \n\n Age >18yrs \n\n FEV1: Forced Vital Capacity (FVC) ratio < 0.70 following 2 puffs of albuterol \n\n FEV1 greater than 50% predicted \n\n ", - "exclusion_criteria": ": \n\n Exclusion for Asthma EXCLUSION \n\n Other respiratory illness other than asthma \n\n Chronic infectious process \n\n Significant other medical illness \n\n Inability to consent \n\n Pregnancy Exclusion for COPD EXCLUSION \n\n Other respiratory illness other than COPD \n\n Chronic infectious process \n\n Significant other medical illness \n\n Inability to consent \n\n Pregnancy", - "brief_summary": "The purpose of the study is to better understand proteomics of asthma and COPD, and response to therapy. There are two Phases to this study broken into two arms. In Phase I, we propose is to use discovery proteomics and techniques to identify protein expression signatures. Subjects who complete Phase I are eligible, but not required, to enroll in Phase II. In Phase II, we propose to establish and validate the predictive value of protein signatures for treatment responses using inhaled corticosteroids.", - "NCTID": "NCT02487394" - }, - { - "brief_title": "Benefits of Liquid Oxygen in COPD Patients Presenting Desaturation During Exercise.", - "phase": "Phase 4", - "drugs": "['oxygen']", - "drugs_list": [ - "oxygen" - ], - "diseases": "['Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "112.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical stable moderate to severe COPD (FEV1 <70%, FEV 1 / FVC <70%) total lung capacity (TLC> 80%) without conventional criteria for LTOT, optimal medical therapy, mean SpO2 \u2264 88% during the 6 minuts walking test and active life outside the home, other than active smoking or are in program respiratory rehabilitation. \n\n ", - "exclusion_criteria": ": \n\n Current smokers - Presence of respiratory failure and criteria for LTOT (PO2 <55 mmHg or 55-60 mmHg associated with pulmonary arterial hypertension, chronic cor pulmonale, congestive heart failure, arrhythmias or polycythemia). - Presence of impaired mobility - Cognitive impairment or intellectual disability to fill in questionnaires - No acceptance of liquid oxygen - Presence of active comorbidities (cardiovascular disease, rheumatologic, renal, hepatic) - Participation in pulmonary rehabilitation programs", - "brief_summary": "The purpose of this study is analyzed the impact of oxygen adjusted during exercise in COPD patients without conventional for LTOT but with exercise desaturation.", - "NCTID": "NCT02273830" - }, - { - "brief_title": "Efficacy and Safety of Tiotropium Compared to Salmeterol and Placebo in Patients With Chronic Obstructive Bronchitis (COPD)", - "phase": "Phase 3", - "drugs": "['Tiotropium inhalation powder capsules', 'Salmeterol inhalation aerosol', 'Placebo inhalation aerosol', 'Placebo inhalation powder capsules']", - "drugs_list": [ - "Tiotropium inhalation powder capsules", - "Salmeterol inhalation aerosol", - "Placebo inhalation aerosol", - "Placebo inhalation powder capsules" - ], - "diseases": "['Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "584.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 40 years. \n\n A diagnosis of relatively stable, moderate to severe COPD with: \n\n Screening FEV1 \u2264 60% of predicted normal value (calculated according to European Community for Coal and Steel (ECCS) criteria and screening FEV1/FVC \u2264 70% \n\n Smoking history \u2265 10 pack-years (a pack-year is 20 cigarettes per day for one year or equivalent) \n\n Ability to be trained in the proper use of the HandiHaler\u00ae device and Metered Dose Inhaler (MDI). \n\n Ability to perform all study related tests including the Shuttle Walking Test, acceptable pulmonary function tests, including Peak expiratory flow rate (PEFR) measurements, and maintenance of diary card records. \n\n Ability to give written informed consent in accordance with Good Clinical Practice and local regulations. \n\n ", - "exclusion_criteria": ": \n\n Clinically significant diseases other than COPD. \n\n Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion, will be excluded. \n\n All patients with a serum glutamic oxaloacetic transaminase (SGOT) > 80 IU/L, serum glutamic pyruvic transaminase (SGPT) > 80 IU/L, bilirubin >2.0 mg/dL or creatinine > 2.0 mg/dL will be excluded regardless of clinical condition. \n\n A recent history (i.e., one year or less) of myocardial infarction. \n\n Any cardiac arrhythmia requiring drug therapy or hospitalisation for heart failure within the past three years. \n\n Inability to abstain from regular daytime use of oxygen therapy for more than 1 hour per day. \n\n Known active tuberculosis. \n\n History of cancer within the last five years (excluding basal cell carcinoma) \n\n History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis. \n\n Patients who have undergone thoracotomy with pulmonary resection. \n\n Any upper respiratory infection in the past six weeks prior to the screening visit or during the run-in period. \n\n Current participation in a pulmonary rehabilitation programme or completion of a pulmonary rehabilitation programme in the six week prior to the screening visit. \n\n Known hypersensitivity to anticholinergic drugs, salmeterol, or any of the components of the lactose powder capsule or MDI delivery systems. \n\n Known symptomatic prostatic hypertrophy or bladder neck obstruction. \n\n Patients with known narrow-angle glaucoma. \n\n Current treatment with cromolyn sodium or nedocromil sodium. \n\n Current treatment with antihistamines (H1 receptor antagonists). \n\n Oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day. \n\n Current use of \u03b2-blocker medication. \n\n Current treatment with monoamine oxidase inhibitors or tricyclic antidepressants. \n\n Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception. \n\n Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count > 600mm3. \n\n History of and/or active significant alcohol or drug abuse. \n\n Concomitant or recent use of an investigational drug within one month or six half lives (whichever is greater) prior to the screening visit. \n\n Changes in the pulmonary therapeutic plan within the six weeks prior to the screening visit. \n\n Inability to comply with the medication restrictions specified in Section 4.2 of the trial protocol", - "brief_summary": "The objective of this study is to compare the long-term (six month) bronchodilator efficacy and safety of tiotropium inhalation capsules, salmeterol inhalation aerosol and placebo inpatients with COPD.", - "NCTID": "NCT02173691" - }, - { - "brief_title": "Endothelial Dysfunction and Chronic Obstructive Pulmonary Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Pulmonary Disease', 'Endothelial Dysfunction']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease", - "Endothelial Dysfunction" - ], - "enrollment": "117.0", - "inclusion_criteria": "inclusion criteria: \n\n COPD patients in stable condition ( without exacerbation min 1 months ago) \n\n Over 40 years \n\n History of at least 10 py \n\n ", - "exclusion_criteria": ": \n\n acute exacerbation of COPD \n\n active malignancy \n\n autoimmune disease \n\n acute myocardial infarction \n\n diabetes mellitus with late complications \n\n congestive heart failure \n\n women of childbearing potential", - "brief_summary": "The purpose of this study is to investigate the role of endothelial dysfunction in chronic obstructive pulmonary disease.", - "NCTID": "NCT02092675" - }, - { - "brief_title": "High Risk Populations Among COPD Patients in Japan", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['COPD']", - "diseases_list": [ - "COPD" - ], - "enrollment": "1016.0", - "inclusion_criteria": "inclusion criteria \n\n Patients with a diagnosis of COPD (FEV1/FVC<0.7 confirmed based on the past medical records) \n\n Patients aged 40 years and over at the diagnosis of COPD \n\n Outpatient \n\n 10 or more pack-years of current or former smokers \n\n Patients who have traceable medical records of COPD (including the results of spirometry) going back more than a year \n\n Patients who meet any of the following two criteria \n\n Patients who have medical records of the results of spirometry at more than two different time points excluding the time point of COPD exacerbations* for the past 3 years \n\n Patients who can provide the results of reversibility testing for respiratory tract \n\n Patients who give written informed consent regarding the participation in this study \n\n ", - "exclusion_criteria": " \n\n Patients currently with COPD exacerbations \n\n Patients who currently enroll in the other interventional study including clinical trials \n\n Patients who concurrently develop or have a history of lung cancer \n\n Patients who are disabled to understand the study procedure or answer the questionnaire (i.e. due to the history of alcohol or drug abuse)", - "brief_summary": "The patients with complications of COPD and asthma have features mixed with two diseases, COPD and asthma. Therefore, the outcomes are worsened if the patients with COPD have symptoms overlapped with asthma, however, no sufficient data exist in Japan for estimating the prevalence of ACOS in patients with COPD. The primary objective of this NIS is to clarify the proportion of ACOS defined by GINA and GOLD in patients with COPD. The main secondary objectives are To explore the features of history of COPD exacerbations, symptoms, eosinophilic inflammation and patient background in patients with ACOS, to clarify the history of COPD exacerbations in patients with COPD, to evaluate the degrees of eosinophilic inflammation of the respiratory tract in patients with COPD and to evaluate the symptoms in patients with COPD. This is a cross-sectional study targeting COPD patients receiving outpatient treatment and follow-up by physicians in Japan. FSI is scheduled as 2Q 2015 and DBL would be locked by 3Q 2015.", - "NCTID": "NCT02413359" - }, - { - "brief_title": "Predictive Ability of the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) for Acute Exacerbations (PACE) in Patients With COPD", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "70.0", - "inclusion_criteria": "inclusion criteria: \n\n Type of subject: Outpatients \n\n Informed consent: Subjects must give their signed and dated written informed consent to participate. \n\n Gender: Male or Female \n\n Age: 40 years of age or older at Visit 1 \n\n COPD diagnosis: Documented diagnosis of COPD at least 6 months prior to Visit 1 in accordance with the following definition by the GOLD (Global Initiative for Chronic Obstructive Lung Disease) guideline: Post bronchodilator FEV1/FVC < 0.7. \n\n History of exacerbations: At least one COPD exacerbation which required the use of any additional treatment in the last 12 months prior to Visit 1. \n\n For subjects who were diagnosed between 6 to 12 months prior to Visit 1, they should have at least one COPD exacerbation that required the use of any additional treatment since diagnosis. \n\n Tobacco use: Smokers or ex-smokers with a smoking history of more than 10 pack years. \n\n ", - "exclusion_criteria": ": \n\n Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study \n\n Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if COPD is the current diagnosis. \n\n Non-compliance: Subjects unable to comply with any aspect of this study protocol or scheduled visits to the study centre", - "brief_summary": "Chronic Obstructive Pulmonary Disease (COPD) is a major health concern, with a substantial impact on a patient's life. However, the impact of COPD is currently under-recognised and, as a result, COPD is under-treated. An exacerbation of COPD is a major element that causes poor quality of life and loss of productivity. Therefore, minimizing the frequency of exacerbations is a short term treatment goal in COPD management and could improve Quality of Life (QoL) significantly in all severity groups of COPD.~Although the use of spirometry for the determination of disease severity in COPD is supported by guidelines, a lung function test alone does not provide a measurement of the overall impact of COPD on health status and is not generally available especially in primary care centre. Therefore, a standardised and effective dialogue between patients and physicians in a consultation could address the impact of COPD on a patient's QoL in this situation.~The COPD Assessment Test (CAT), recently launched in 2009, is a short and simple, self-administered questionnaire designed to assess the condition of patients and overall impact of COPD, and to improve patient-physician communication. It has been proven that the CAT has good repeatability and discriminative properties which suggest that it is sensitive to treatment effects at a group level. The CAT score with its better ability to assess the impact of COPD on patients, suggests potential to predict a significant change in COPD status such as acute exacerbations of COPD.~Since the CAT is designed to assess the impact of COPD on the patient by measuring overall impairment, it has better correlations with other instruments, such as the Clinical COPD Questionnaire (CCQ), MRC (Medical Research Council) dyspnoea scale, St George's Respiratory Questionnaire (SGRQ),and the 6-minute walk test. However, it does not correlate well with FEV1 (Forced Expiratory Volume in One Second).~While the CAT shares some similarities with other questionnaires, there are several important differences. For example, the SGRQ is substantially longer than the CAT, is complex to administer and requires the use of a computer for scoring. The CAT is designed to provide a holistic measure of the impact of COPD on the patient, whereas the MRC dyspnoea scale only measures dyspnoea, and the CCQ only assesses clinical disease control. Thus, the CAT is the only validated, short and simple assessment test which can provide a holistic measure of the impact of COPD on patients, ensuring both the physicians and the patients gain the understanding needed to manage COPD optimally.~QoL is defined as an individual's perception of their position in their life in the context of the culture and value systems. Therefore, the extent of understanding of the questionnaire might be influenced by language and ethnicities. Since the validation findings so far have been based on data from the US and Europe, PACE may provide better quality of data across ethnic groups given that mainly Asian subjects will participate in this study.~PACE is designed to evaluate whether the CAT has a high predictive value in detecting subsequent exacerbations of COPD. If so, this result might enable both patients and physicians to better target and optimise management. The primary objective is to evaluate the predictability of the CAT to have subsequent exacerbations in COPD patients. Secondary objectives are to evaluate the predictability of the CAT to have moderate to severe exacerbations or time to the first exacerbation, to identify risk predictors for COPD exacerbations, and to evaluate correlations between CAT scores and FEV1 values, or MRC dyspnea scores. An experimental objective is to evaluate the correlation between the CAT score between 2 consecutive follow-ups (e.g. Week 8 & baseline, Week 16 & Week 8) and a COPD exacerbation over the following treatment period adjusting for demographics, MRC scores, lung function parameters, medical history, and therapy history.~PACE is a multicentre, prospective, observational study designed to evaluate the predictability of the CAT score to have COPD exacerbations over 24 weeks. During the study, subjects continue taking their regular prescribed treatment. Investigators are free to make medication adjustments where required. Eligible subjects will have a clinic visit every 8 weeks, during which they will complete the CAT questionnaire, the Exacerbation Check List (ECL), MRC dyspnea scale, and spirometry. A regular phone call is placed every 8 weeks in between clinic visits to collect data for the ECL.There is no follow-up period.~550 male and female outpatient subjects will be recruited for PACE to obtain approximately 300 exacerbation events. This study will capture the winter periods in Australia, China, Korea and Taiwan, when incidence of exacerbations is at its peak.~Statistical analysis will be performed on subjects' data to derive the PACE end-points.", - "NCTID": "NCT01254032" - }, - { - "brief_title": "Prevalence of Malignant and Premalignant Lesions in the Head & Neck in Patients With Chronic Obstructive Pulmonary Disease", - "phase": "", - "drugs": "['Stroboscopic nasopharyngeal laryngoscopy', 'Stroboscopic nasopharyngeal laryngoscopy', 'Stroboscopic nasopharyngeal laryngoscopy']", - "drugs_list": [ - "Stroboscopic nasopharyngeal laryngoscopy", - "Stroboscopic nasopharyngeal laryngoscopy", - "Stroboscopic nasopharyngeal laryngoscopy" - ], - "diseases": "['COPD, HEAD&NECK CANCER,SCREENING']", - "diseases_list": [ - "COPD", - "HEAD&NECK CANCER,SCREENING" - ], - "enrollment": "250.0", - "inclusion_criteria": "inclusion criteria: \n\n group of adult COPD patients. \n\n Adult patients with smoking history and no clinical manifestation of COPD who will be recruited form the institute of pulmonary medicine and the otolaryngology outpatient clinic. \n\n Adult patients with lung disease unrelated to smoking, i.e. bronchial asthma who will be recruited from the institute of pulmonary medicine \n\n ", - "exclusion_criteria": ": \n\n Patients with an acute disease or COPD exacerbation \n\n Pregnant patients \n\n Patients who were intubated \u22643 months prior to inclusion \n\n Patients with a medical history of surgical intervention in the upper airway \n\n Patients with a medical history of malignant disease in the upper airway \n\n Patients who underwent radiotherapy of head and neck", - "brief_summary": "Head and neck cancers usually occur in patients who have a history of long tobacco use. Chronic obstructive pulmonary disease (COPD) is a chronic progressive disease of the airways and lung parenchyma that is also associated with exposure to tobacco. COPD and head & neck cancer share a common environmental risk factor in cigarette smoke exposure. the investigators hypothesize that patients with chronic lung disease related to smoking have a higher risk to develop cancer in the head and neck.~The investigators designed a study to assess the prevalence of cancer and pre-cancer disease in the head & neck in patients with chronic lung disease. the investigators will examine patients with and without a history of smoking and chronic lung disease in order to determine the prevalence of head and neck cancer in the different groups. The patients who will be included in the study will undergo comprehensive evaluation of their lung function and voice performance.~This study is a joint effort of the Pulmonology Institute and the Department of Otolaryngology, Head & Neck Surgery in Israel and the Netherlands.", - "NCTID": "NCT02333812" - }, - { - "brief_title": "12-week Treatment With Inhaled Tiotropium (18 mcg Once Daily) on Lung Function and Static Lung Volumes in Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Patients. Correlation to Dyspnoea Scales", - "phase": "Phase 3", - "drugs": "['Tiotropium inhalation capsules', 'Placebo inhalation capsules']", - "drugs_list": [ - "Tiotropium inhalation capsules", - "Placebo inhalation capsules" - ], - "diseases": "['Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "116.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female patients 40 years of age or older. \n\n All patients had to have a diagnosis of COPD and had to meet the following spirometric and static lung volume criteria: \n\n Patients had to have relatively stable, moderate to severe airway obstruction with: \n\n FEV1 \u2264 50 % of predicted value, \n\n FEV1/SVC \u2264 70 %. \n\n All patients had to have the presence of lung hyperinflation as demonstrated by RV \u2265 125 % of predicted value. \n\n Predicted normal values were calculated according to European Community Coal and Steel (ECCS) \n\n Males: \n\n FEV1 predicted (L) = 4.30 x height (metres) - 0.029 x age (years) - 2.49 \n\n RV predicted (L) = 1.31 x height (metres) + 0.022 x age (years) - 1.23 \n\n Females: \n\n FEV1 predicted (L) = 3.95 x height (metres) - 0.025 x age (years) - 2.60 \n\n RV predicted (L) = 1.81 x height (metres) - 0.016 x age (years) - 2.00 \n\n Patients had to be current or ex-smokers with a smoking history of more than 10 pack-years (p.y.). Patients who never smoked cigarettes were excluded. \n\n Number of p.y. = Number of cigarettes/day / 20 x years of smoking \n\n Patients had to be able to perform all study related tests including the SWT, acceptable pulmonary function tests including PEFR measurements, and had to be able to maintain records during the study period as required in the protocol. \n\n Patients had to be able to inhale medication from the HandiHaler. \n\n All patients had to sign an informed consent form prior to participation in the trial i.e. prior to pre-study washout of their usual pulmonary medication. \n\n Eosinophilia < 600/mm\u00b3 documented in the past year (if not available, a blood count cell was performed). \n\n ", - "exclusion_criteria": ": \n\n Patients with a history of asthma, allergic rhinitis or atopy. \n\n Patients with significant diseases other than COPD were excluded. A significant disease was defined as a disease which in the opinion of the investigator may have either put the patient at risk because of participation in the study or a disease which may have influenced the results of the study or the patient's ability to participate in the study. \n\n Patients with a recent history (i.e. one year or less) of myocardial infarction. \n\n Patients with a recent history (i.e. three years or less) of heart failure, pulmonary oedema, or patients with cardiac arrhythmia requiring drug therapy. \n\n Patients who regularly used daytime oxygen therapy for more than one hour per day and in the investigator.s opinion was unable to abstain from the use of oxygen therapy. \n\n Patients with known active tuberculosis. \n\n Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma were allowed. \n\n Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis. \n\n Patients who underwent thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reason were evaluated as per exclusion criterion No. 2. \n\n Patients with lower respiratory tract infection in the past six weeks prior to the Screening Visit (Visit 1) or during the run-in period. \n\n Patients who were currently in a pulmonary rehabilitation programme or who completed a pulmonary rehabilitation programme in the six weeks prior to the Screening Visit (Visit 1). \n\n Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system. \n\n Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction. \n\n Patients with known narrow-angle glaucoma. \n\n Patients who were treated with \u03b2-blockers, cromolyn sodium or nedocromil. \n\n Patients who were treated with antihistamines (H1 receptor antagonists) or antileukotrienes. \n\n Patients who were treated with monoamine oxidase inhibitors or tricyclic antidepressants. \n\n Patients using oral corticosteroid medication at unstable doses (i.e. less than six weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day. \n\n Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intra-uterine devices, diaphragm or subdermal implants). \n\n Patients with history and/or active significant alcohol or drug abuse. \n\n Patients who took another investigational drug within one month or ten half lives (whichever was greater) prior to Visit 1.", - "brief_summary": "Determine the effect of 12-week treatment with inhaled tiotropium bromide on lung function and static lung volumes, correlate this effect with dyspnoea in COPD patients.", - "NCTID": "NCT02172378" - }, - { - "brief_title": "MISSION COPD - Modern Innovative SolutionS in Improving Outcomes iN COPD", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "114.0", - "inclusion_criteria": "inclusion criteria - Patients: \n\n Male of Female, aged 18 years or above. \n\n Attended the MISSION clinic as a patient. \n\n Participant is willing and able to give informed consent for participation in the study. \n\n ", - "exclusion_criteria": " - Patients: \n\n - The patient is unable or unwilling to give consent \n\n inclusion criteria - Health Care Professionals \n\n Male or Female, aged 18 or above. \n\n Attended the MISSION clinic as a health care professional \n\n Participant is willing and able to give informed consent for participation in the study. \n\n ", - "brief_summary": "MISSION is a new and novel way of delivering highly specialised Chronic Obstructive Pulmonary Disease (COPD) care and has the potential to change the way COPD care across the UK is delivered as well as services for other long term health conditions. The MISSION model has been piloted in asthma which is the subject of an ongoing research study. This is the first model of this type in COPD and the current research study aims to evaluate the outcomes of the project. This will be done in several different ways. The study is a mixed methods evaluation of the new service comparing outcomes before and after the clinic using retrospective data analysis and prospective qualitative interview. The study will be conducted at Portsmouth Hospitals NHS Trust and will recruit patients who attend MISSION COPD clinics as well as staff who attended MISSION clinics in a professional capacity.", - "NCTID": "NCT02534766" - }, - { - "brief_title": "A Behavioral Therapy for Insomnia Co-existing With COPD", - "phase": "", - "drugs": "['Cognitive Behavioral Therapy for Insomnia', 'COPD Education', 'Attention Control']", - "drugs_list": [ - "Cognitive Behavioral Therapy for Insomnia", - "COPD Education", - "Attention Control" - ], - "diseases": "['Insomnia', 'COPD', 'Chronic Obstructive Pulmonary Disease', 'Fatigue']", - "diseases_list": [ - "Insomnia", - "COPD", - "Chronic Obstructive Pulmonary Disease", - "Fatigue" - ], - "enrollment": "109.0", - "inclusion_criteria": "inclusion criteria: \n\n mild to very severe COPD. \n\n age \u2265 45 years of age with no other major healthproblems. \n\n clinically stable at the time of enrollment into the study. \n\n insomnia. \n\n ", - "exclusion_criteria": ": \n\n evidence of restrictive lung disease or asthma. \n\n pulse oximetry reading of < 90% at rest or < 85% at night for > 5 min. \n\n evidence of a major sleep disorder other than insomnia. \n\n hypnotic use. \n\n acute respiratory infection within the previous 2 months. \n\n presence of a potentially debilitating disease such as cancer, congestive heart failure, kidney disease, liver failure or cirrhosis; evidence of alcohol or drug abuse, musculoskeletal or degenerative nerve disease. \n\n a self-reported current diagnosis of major depression or psychiatric disease or a Hospital Anxiety and Depression Scale (HADS) depression score of > 11. \n\n currently participating in pulmonary rehabilitation.", - "brief_summary": "Difficulty falling asleep, staying asleep or poor quality sleep (insomnia) is common in people with chronic obstructive pulmonary disease. Insomnia is related to greater mortality, with four times the risk of mortality for sleep times < 300 minutes. Insomnia is also related to greater morbidity, with 75% greater health care costs than people without insomnia. However, insomnia medications are used with caution in COPD due to potential adverse effects. Common features of COPD such as dyspnea, chronic inflammation, anxiety and depression also affect insomnia and can interfere with therapy outcomes. While cognitive behavioral therapy for insomnia (CBT-I), a therapy that provides guidance on changing unhelpful sleep-related beliefs and behavior, is effective for people with primary insomnia and people with other chronic illnesses, the efficacy and mechanisms of action of such a therapy are yet unclear in people with both insomnia and COPD. The objective in this application is to rigorously test efficacy of two components of insomnia therapy - CBT-I and COPD education (COPD-ED) - in people with coexisting insomnia and COPD, and to identify mechanisms responsible for therapy outcomes. The central hypothesis is that both CBT-I and COPD-ED will have positive, lasting effects on objectively and subjectively measured insomnia and fatigue. The rationale for the proposed study is that once the efficacy and mechanisms of CBT-I and COPD-ED are known, new and innovative approaches for insomnia coexisting with COPD can be developed, thereby leading to longer, higher quality and more productive lives for people with COPD, and reduced societal cost due to the effects of insomnia. The investigators plan to test our central hypothesis by completing a randomized controlled comparison of CBT-I, COPD-ED and non-COPD, non-sleep health education attention control (AC) using a highly efficient 4-group design. Arm 1 comprises 6 weekly sessions of CBT-I+AC; Arm 2=6 sessions of COPD-ED+AC; Arm 3=CBT-I+COPD-ED; and Arm 4=AC. This design will allow completion of the following Specific Aims: 1. Determine the efficacy of individual treatment components, CBT-I and COPD-ED, on insomnia and fatigue. 2. Define mechanistic contributors to the outcomes after CBT-I and COPD-ED. The research proposed in this application is innovative because it represents a new and substantive departure from the usual insomnia therapy, namely by testing traditional CBT-I with education to enhance outcomes.", - "NCTID": "NCT01973647" - }, - { - "brief_title": "Effects of Nutritional Supplementation in Malnourished Patients in Stable COPD", - "phase": "Phase 4", - "drugs": "['enteral nutrition emulsion']", - "drugs_list": [ - "enteral nutrition emulsion" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease(COPD)', 'Malnutrition']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease(COPD)", - "Malnutrition" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients from Zhujiang Hospital affiliated from Southern Medical University \n\n Patients aged between 40 and 90 years old \n\n Patients gendered into male or female \n\n Patients with pulmonary function test of FEV1/FVC<70% and FEV1<80% predicted \n\n Patients presenting one or more of the following situations of malnutrition or nutritional risk: BMI <21 kg/m2 (or<23 kg/m2 in patients \u2265 65); unintentional weight loss >10% in the past 6 months; unintentional weight loss >5% in last month; FFMI <15 kg/m2 (women) or <16 kg/m2 (men) \n\n Patients able to answer question \n\n Patient able to eat and drink \n\n Patients who signed informed consent \n\n ", - "exclusion_criteria": ": \n\n Patients with signs of an airway infection \n\n Patients with malignant disorders \n\n Patients with recent surgery \n\n Patients with gastrointestinal ,cardiovascular diseases,neurological diseases or endocrine disease \n\n Patients with bullae lung \n\n patients treated with oral steroids or immunosuppressors \n\n Patients requiring other nutritional supplements or parenteral nutrition \n\n Patients suffering from acute exacerbation over the previous 4 weeks \n\n Patients with lack of motivation or poor compliance", - "brief_summary": "Insufficient energy intake and systematic inflammation lead to malnutrition in patients with chronic obstructive pulmonary disease (COPD). Nutritional supplementation improves the patients'nutritional status by increasing energy intake and providing anti-inflammatory elements\uff0cwhich can relieve the patients' symptoms and delay the disease progression.", - "NCTID": "NCT02197871" - }, - { - "brief_title": "Cough Responses to Tussive Agents in Health and Disease", - "phase": "", - "drugs": "['Cough Challenge Tests', 'ambulatory cough recording', 'Cough questionnaires']", - "drugs_list": [ - "Cough Challenge Tests", - "ambulatory cough recording", - "Cough questionnaires" - ], - "diseases": "['Asthma', 'Chronic Obstructive Airway Disease', 'Chronic Cough']", - "diseases_list": [ - "Asthma", - "Chronic Obstructive Airway Disease", - "Chronic Cough" - ], - "enrollment": "102.0", - "inclusion_criteria": "inclusion criteria: \n\n General \n\n Adult subjects aged 18 years and over \n\n Meet criteria for subject groups as outlined below \n\n (1) Healthy volunteers \n\n Non-smokers \n\n No history of respiratory disease \n\n (2) Healthy smokers \n\n Current smokers with smoking history of \u226510 pack years \n\n Spirometry within normal limits i.e. FEV1>80% predicted and FEV1/FVC ratio >75% predicted \n\n (3) Asthma \n\n Physician diagnosis of asthma \n\n Airways hyperresponsiveness to methacholine; PC20<16mg/ml (within last 2 years) \n\n Non-smokers or ex-smoker with smoking history of \u226410 pack years \n\n (4) COPD \n\n Physician diagnosis of COPD \n\n Ex-smokers with smoking history of \u226520 pack years \n\n Spirometry demonstrating airflow obstruction i.e. FEV1/FVC ratio <70% \n\n (5) Chronic Cough \n\n History of a dry cough for >8 weeks \n\n Normal CXR \n\n Non-smokers or ex-smoker with smoking history of \u226410 pack years \n\n ", - "exclusion_criteria": ": \n\n 1) Symptoms of upper respiratory tract infection within the last 6 weeks 2) Participation in another clinical trial of an investigational drug within the last 4 weeks 3) Use of medication likely to alter cough reflex sensitivity i.e. ACE inhibitors, codeine phosphate, morphine sulphate, 4) Patients with severe respiratory disease i.e. FEV1 < 1 litre, 5) Significant medical co-morbidities likely to affect ability to participate in the trial or affect cough reflex sensitivity e.g. diabetes, stroke, Parkinson's disease, multiple sclerosis etc.", - "brief_summary": "The sensitivity of a persons cough reflex can be measured by getting them to breath in (inhale) irritant chemicals. The purpose of this clinical research study is to test the sensitivity of the cough reflex to a variety of chemicals that can be inhaled to see if coughing responses are different between healthy people and people with respiratory problems that make them cough.", - "NCTID": "NCT01297790" - }, - { - "brief_title": "Ease of Use and Correct Use Study of Placebo ELLIPTA\u00ae Inhaler in COPD Subjects", - "phase": "Phase 4", - "drugs": "['Placebo', 'Questionnaire']", - "drugs_list": [ - "Placebo", - "Questionnaire" - ], - "diseases": "['Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "278.0", - "inclusion_criteria": "inclusion criteria: \n\n Age: >=40 years of age at Visit 1 \n\n Diagnosis of COPD with a documented history of COPD for at least one year, in accordance with the definition by the American Thoracic Society/European Respiratory Society. \n\n Severity of Disease: Post albuterol/salbutamol forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio <0.70 and FEV1 <=70% of predicted obtained within two years of Visit 1. \n\n Smoking History: Current or former (defined as subjects who have quit smoking for at least 3 months prior to Screening/Visit 1) cigarette smokers with a >10 pack-year smoking history (Number of pack years = [number of cigarettes per day divided by 20] x number of years smoked [e.g., 10 pack-years is equal to 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years]). \n\n Current COPD Therapy: Currently receiving maintenance (with one or more long-acting bronchodilators, such as a long-acting muscarinic antagonist (LAMA; also known as a long-acting anti-cholinergic) or long-acting beta 2-agonist (LABA) inhaler therapy (with no prior or ongoing use of ELLIPTA inhaler) for the treatment of COPD. Subjects must be able to continue using their currently prescribed COPD maintenance inhaler therapy throughout the study and as needed short acting beta-adrenergic agonist (SABA) for rescue use. \n\n Ability to Use Inhalers: Subject must be able to demonstrate correct use of ELLIPTA inhaler within three attempts at Visit 1. \n\n Males \n\n Females who are not pregnant or not planning a pregnancy during the study or not lactating. \n\n Informed Consent: Capable of giving signed and dated written informed consent which includes compliance with the requirements and restrictions listed in the consent form and in the protocol. \n\n Subject understands and is willing, able, and likely to comply with study procedures and restrictions. \n\n Subject must be able to read, comprehend, and record information in English. \n\n ", - "exclusion_criteria": ": \n\n A subject will not be eligible for inclusion in this study if any of the following criteria apply \n\n Asthma: Subjects with a current primary diagnosis of asthma. \n\n COPD medications: Receiving only inhaled short-acting beta-adrenergic agonists, i.e., albuterol as their daily COPD therapy (as needed [prn] or regularly scheduled); Has changed maintenance COPD treatment within 4 weeks prior to Screening/Visit 1 or plans to change COPD treatment within 4 weeks of Visit 1. \n\n COPD/Exacerbations/Hospitalization: Subjects that have experienced a COPD exacerbation requiring systemic corticosteroids (oral, parenteral or depot) and/or antibiotics within four weeks of Visit 1. A subject must not have had any hospitalization for COPD within three months prior to Visit 1; Subjects with uncontrolled COPD, in the investigator's judgment that would affect subject's ability to evaluate ease of use and correct use. \n\n Other Respiratory Disorders: Subjects with other respiratory disorders, including active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases. \n\n Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening/Visit 1. \n\n Oxygen: Use of long-term oxygen therapy (LTOT; defined as oxygen therapy prescribed for greater than 12 hours per day) or nocturnal oxygen. \n\n Other Disease Abnormalities: Historical or current evidence of clinically significant or rapidly progressing or unstable cardiovascular, neurological, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the analysis if the disease/condition exacerbated during the study; Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study. \n\n Compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures, or unable to continue their current COPD medications. \n\n Alcohol and Drug Abuse: A known or suspected history of alcohol or drug abuse within the last 2 years. \n\n A history of hypersensitivity to any components of the study inhaler (e.g., lactose, magnesium stearate). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates participation will also be excluded. \n\n Prior or Ongoing use of the ELLIPTA inhaler (including both investigational and commercially available product). \n\n Investigational Product: Subjects who have received an investigational drug and/or medical device within 30 days of entry into this study (Screening/Visit 1), or within five drug half-lives of the investigational drug, whichever is longer.", - "brief_summary": "Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The mainstay for treatment involves the use of inhaled medications, including short and/or long-acting bronchodilators along with inhaled corticosteroids. For inhaled medications, the choice of inhalation device is an important consideration because an inadequate technique reduces the effects of inhalation. Therefore, the development of an easy-to-use inhaler that delivers the drug to the lungs effectively, is important. This study will assess the correct use of the ELLIPTA inhaler by subjects with COPD and to assess ease of use of the ELLIPTA inhaler, as rated by those subjects determined to be using the inhaler correctly. Study will be divided into two visits i.e. Screening/Visit 1 (day 1) and Visit 2 (Day 28 +/-2) with a phone call on Day 8+/-2 days of Visit 1 to assess safety. In this multi-center, single-arm, randomised (to receive one of two versions of the ELLIPTA inhaler Ease of Use questionnaires), open-label, placebo study, only subjects who are have never used the ELLIPTA inhaler before and have an established diagnosis of COPD and receiving COPD therapy and are able to demonstrate correct use of the ELLIPTA inhaler at Visit 1 will be considered eligible to participate in this study. Approximately 252 subjects will be screened with an expectation of 208 subjects completing the study while demonstrating correct ELLIPTA inhaler use at visit 2.~ELLIPTA is a registered trademark of the GlaxoSmithKline Group of Companies.", - "NCTID": "NCT02586493" - }, - { - "brief_title": "Study of a Tiotropium Inhaler For Shortness of Breath in Advanced Non-Small Cell Lung Cancer", - "phase": "Phase 2", - "drugs": "['Tiotropium', 'Placebo']", - "drugs_list": [ - "Tiotropium", - "Placebo" - ], - "diseases": "['NSCLC', 'Dyspnea']", - "diseases_list": [ - "NSCLC", - "Dyspnea" - ], - "enrollment": "34.0", - "inclusion_criteria": "inclusion criteria: \n\n Histologically or cytologically proven incurable stage IIIb or stage IV non-small cell lung cancer. \n\n Dyspnea as defined by a score of 2 or higher on the 10-point Dyspnea Numeric Scale (Appendix 2). \n\n New dyspnea or worsening dyspnea within the last 6 months per patient reporting. \n\n ", - "exclusion_criteria": ": \n\n Age < 18. \n\n An FEV1 / FVC ratio < 0.7 with an FEV1 of < 80% predicted post-bronchodilator. \n\n Life expectancy < 3 months. \n\n Significant worsening of dyspnea over the last week such that an acute cardiac or respiratory condition is considered likely (e.g. pneumonia, heart failure). \n\n Myocardial infarction within the previous month. \n\n Heart rate \u2265 120. \n\n Active tuberculosis or tuberculosis receiving antibiotic therapy. \n\n Current or previous use of ipratropium, tiotropium, or oxitropium (see Appendix 6). \n\n Sensitivity to atropine. \n\n Pre-existing diagnosis of asthma or moderate to severe Chronic Obstructive Pulmonary Disease \n\n Use of beta-adrenergic bronchodilators more than once per week. \n\n Use of experimental therapy with known cholinergic or adrenergic effects. \n\n Uncontrolled glaucoma. \n\n Urinary retention. \n\n An active upper or lower respiratory infection or having taken antibiotics for any recent respiratory infection within 4 weeks. \n\n Symptomatic pleural or pericardial effusion. \n\n Evidence of reversible proximal endobronchial obstruction. \n\n Oxygen saturation < 90%. \n\n A hemoglobin of < 100 g/litre. Testing is to be within 4 weeks of randomization. \n\n Calculated or urine creatinine clearance \u2264 50 mL/min (see Appendix 5 for calculation). Testing it to be within 4 weeks of randomization. \n\n Weight loss > 10% of usual body weight within 6 months. \n\n Known pregnancy or lactating. \n\n Unable to independently fill out quality of life forms or give informed consent. \n\n -", - "brief_summary": "The feeling of shortness of breath is very common in lung cancer. It is uncomfortable for patients and upsetting for their family. Although drugs like morphine and oxygen can help some patients feel better, they don't help everybody, and they are not used in patients with early symptoms. More relief is needed for these patients. The investigators are studying a drug called tiotropium, which is used in emphysema. It is an inhaler that opens the airways to allow easier breathing. Every patient will get the drug but also a placebo, in a random (flip of a coin) order. They will get each for 2 weeks. The investigators will see if they feel better with the drug.", - "NCTID": "NCT01172925" - }, - { - "brief_title": "Characterisation of Healthy Volunteers, Asthma and Chronic Obstructive Pulmonary Disease Patients for Inhalation Profile, Pharyngometry, Spirometric Indices and Lung Morphometry", - "phase": "Phase 1", - "drugs": "['Inhalation Profiling']", - "drugs_list": [ - "Inhalation Profiling" - ], - "diseases": "['Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "106.0", - "inclusion_criteria": "inclusion criteria: \n\n A subject will be eligible for inclusion in this study only if all of the following criteria apply. \n\n All volunteers must be aged between 21 to 70 years inclusive and be competent to understand and give informed consent. \n\n All female volunteers of child bearing potential must have provided a negative pregnancy test before inclusion and prior to any HRCT scan. \n\n Body weight < 120 kg and BMI within the range 18 - 35 kg/m2 (inclusive). \n\n Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. \n\n Available to complete the study \n\n Subject will then be included only if they fulfil all criteria for the following relevant cohort Healthy: Cohort \n\n Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history and physical. A subject with a clinical abnormality or parameters outside the reference range for the population being studied may be included if the Investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. \n\n Non-smokers (never smoked or not smoking for >12 months with <1 pack year history) (Pack years = (cigarettes per day smoked/20) x number of years smoked)) \n\n No history of a chronic respiratory disorder. \n\n No history of acute respiratory disease within four weeks prior to inclusion. \n\n No history of breathing problems such as a history of asthma, unless the asthma was in childhood and has now completely resolved, no longer requiring maintenance or intermittent therapy. \n\n No other significant medical disorder that may affect the respiratory system or that causes significant disability. \n\n Asthmatic: Cohort \n\n Clinically diagnosed with asthma, for at least 6 months, stratified as either: mild, moderate or severe, based on current treatment, using the British Thoracic Society - - Guidelines on Asthma [BTS, 2009]. For inhaled steroid equivalence to budesonide please refer to the GINA guidelines [GINA, 2008] \n\n Mild, defined Step 1 or 2 by BTS Asthma Guidelines \n\n Moderate, defined as step 3 by BTS Asthma Guidelines \n\n Severe, defined as step 4 or 5 by BTS Asthma Guidelines \n\n Non-smokers (never smoked or not smoking for >12 months with <1 pack year history (Pack years = (cigarettes per day smoked/20) x number of years smoked)) \n\n Able to withhold from short acting bronchodilators for 6 hours and long acting bronchodilators for 12 hours before study assessments \n\n No history of acute respiratory disease within four weeks prior to inclusion. \n\n No history of any other inflammatory lung condition or carcinoma of the lung. \n\n No exacerbation of disease requiring hospitalisation within previous four weeks. \n\n COPD: Cohort \n\n - Clinically diagnosed COPD, for at least 6 months prior to screening, either: mild, moderate or severe/very severe (stage I, II, III/IV) COPD as defined by GOLD guidelines [GOLD 2008]. The following lung function criteria are post bronchodilator \n\n Stage I: \n\n Mild COPD. FEV1/FVC < 70%, FEV1 \u2265 80% predicted with or without chronic symptoms (cough, sputum production) Stage II \n\n Moderate COPD. FEV1/FVC < 70%. 50% \u2264 FEV1 < 80% predicted with or without chronic symptoms (cough, sputum production) Stage III and IV \n\n Severe COPD. FEV1/FVC < 70%. 30% \u2264 FEV1 < 50% predicted with or without chronic symptoms (cough, sputum production) \n\n Very Severe COPD.FEV1/FVC < 70%, FEV1 < 30% predicted or FEV1 < 50% predicted plus chronic respiratory failure \n\n Subject is a smoker or an ex-smoker with a smoking history of at least 10 pack years (Pack years = (cigarettes per day smoked/20) x number of years smoked)). \n\n No history of acute respiratory disease within four weeks prior to inclusion \n\n No history of any other inflammatory lung condition or carcinoma of the lung. \n\n No exacerbation of disease requiring hospitalisation within previous four weeks. \n\n Able to withhold from short acting bronchodilators for 6 hours and long acting bronchodilators for 12 hours before study assessments \n\n ", - "exclusion_criteria": ": \n\n A subject will not be eligible for inclusion in this study if any of the following criteria apply: \n\n As a result of the medical interview, physical examination or screening investigations, the physician responsible considers the volunteer unfit for the study. \n\n Any pregnant female \n\n Volunteers who have a past or present disease, which as judged by the Investigator, may affect subject safety or influence the outcome of the study. \n\n The subject has received an investigational drug or participated in any other research trial within 30 days or five half-lives, or twice the duration of the biological effect of any drug (whichever is longer). \n\n The subject that has both asthma and COPD. \n\n Previous inclusion in a research and/or medical protocol involving nuclear medicine, \n\n Any Radiological investigations with significant radiation burden (a significant radiation burden being defined as ICRP category IIb or above: No more than 10 mSv in addition to natural background radiation, in the previous 3 years including the dose from this study). \n\n The subject has a history of alcohol or drug abuse. \n\n The subject has had a respiratory tract infection within four weeks of the start of the study. \n\n The subject has a history of claustrophobia. \n\n The subject is unable to perform the Multi Channel Recorder and/or Pharyngometry assessments correctly. \n\n The subject has a known allergy or hypersensitivity to milk protein. \n\n Unwillingness or inability to follow any of the procedures outlined in the protocol. \n\n Subject is kept under regulatory of judicial order in an institution. \n\n Subject is mentally or legally incapacitated.", - "brief_summary": "This is a clinical study, with no investigational product, to characterise the inhalation profiles of healthy volunteers, volunteers with mild, moderate and severe Asthma and volunteers with mild, moderate and severe Chronic Obstructive Pulmonary Disease (COPD), through the novel dry powder inhaler.", - "NCTID": "NCT01345266" - }, - { - "brief_title": "Association Between Increased Oxidative Stress, Anti-Inflammatory Fatty Acid Formation, and Airway Infection in People With Asthma and Chronic Obstructive Pulmonary Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Asthma', 'Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Asthma", - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "43.0", - "inclusion_criteria": "inclusion criteria: \n\n No change from the MIA and LEUKO trials \n\n ", - "exclusion_criteria": ": \n\n No change from the MIA and LEUKO trials", - "brief_summary": "Chronic obstructive pulmonary disease (COPD) and asthma are common respiratory diseases in which people experience long-term inflammation of the lungs. Exacerbations, or prolonged worsening of symptoms, of asthma and COPD are often life-threatening and can lead to frequent need for hospitalization. Even with the proper use of bronchodilators, corticosteroids, and other currently available medications, clinical responses among people with COPD and asthma are variable. There remains a significant unmet clinical need for new therapeutic approaches and insights, including the identification of biomarkers to accurately assess the presence of airway infection and intensity of airway inflammation. This study will investigate potential natural biological causes and new biomarkers for increased susceptibility to persistent airway infection in asthma and COPD.", - "NCTID": "NCT00595114" - }, - { - "brief_title": "Outcomes Associated With Early or Delayed Maintenance Treatment Post-Chronic Obstructive Pulmonary Disease Exacerbation", - "phase": "", - "drugs": "['Early maintenance treatment', 'Delayed Maintenance treatment']", - "drugs_list": [ - "Early maintenance treatment", - "Delayed Maintenance treatment" - ], - "diseases": "['Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "3806.0", - "inclusion_criteria": "inclusion criteria: \n\n at least 40 years of age, \n\n continuously enrolled for medical and pharmacy benefits during their pre- and post-period \n\n diagnosis of COPD (ICD 491.xx, 492.xx, 496.xx) \n\n ", - "exclusion_criteria": ": \n\n Patients were excluded if they had MTx in the pre-index period (to ensure inclusion of MTx-na\u00efve patients) or if they received their first MTx during 181 to 365 days of the post-period (as dispensing of MTx unlikely to be related to the index exacerbation). \n\n Additionally, patients were excluded if they had any of the following comorbid conditions anytime during the study period: respiratory cancer, cystic fibrosis, fibrosis due to, bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, or sarcoidosis, and \n\n also if they had other doses (unapproved in the US) of fluticasone propionate-salmeterol xinafoate combination (100/50 mcg or 500/50 mcg) or budesonide dipropionate-formoterol fumarate fixed dose combination (any dose).", - "brief_summary": "The timing of initiating short-term treatment for COPD exacerbations with oral corticosteroids and/or antibiotic therapy has been shown to influence the recovery time of exacerbations with early initiation of exacerbation therapy having a faster symptom recovery compared to delayed initiation. While oral corticosteroids and/or antibiotic therapy are crucial for immediate exacerbation therapy, maintenance therapy with controller medications for COPD has been recommended to reduce the risk of future exacerbations. The initiation of maintenance therapy after a COPD exacerbation has been shown to be beneficial in the reduction of risk of future exacerbations. However, there is a lack of information on whether the timing of this initiation influences the risk of future exacerbations. The following study evaluates the impact of early versus delayed initiation of controller medication therapy for maintenance treatment following a COPD-related exacerbation on outcomes of future exacerbations and costs in patients with COPD.", - "NCTID": "NCT01431911" - }, - { - "brief_title": "Telithromycin in Respiratory Tract Infections", - "phase": "Phase 4", - "drugs": "['telithromycin']", - "drugs_list": [ - "telithromycin" - ], - "diseases": "['Respiratory Tract Infections']", - "diseases_list": [ - "Respiratory Tract Infections" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n General Conditions \n\n Outpatients \n\n Fulfillment of clinical diagnostic criteria for one of the following indications: \n\n Mild to moderate Community Acquired Pneumonia (CAP) \n\n Acute bacterial Exacerbation of Chronic Bronchitis (AECB) \n\n Acute Sinusitis (AS) \n\n For CAP \n\n The Criteria to be fulfilled are: \n\n New onset of at least two of the following: \n\n Cough \n\n Production of purulent sputum \n\n Auscultatory findings compatible with pneumonia, e.g. rales, evidence of pulmonary consolidation \n\n Dyspnea or tachypnea \n\n Fever \n\n Elevated total white blood cell count > 10 000/mm3 or >15% bands regardless of total count \n\n Chest X-ray findings supporting a clinical diagnosis of bacterial pneumonia (e.g. new infiltrate) \n\n For AECB \n\n The Criteria to be fulfilled are: \n\n Chronic bronchitis defined as cough and excessive sputum production for more than 2 consecutive years and on most days in a 3-month consecutive period. \n\n Exacerbation defined by: \n\n Increase in sputum purulence, or \n\n Increase in sputum volume, or \n\n Increase in dyspnea \n\n For AS \n\n The criteria to be fulfilled are: \n\n At least two of the major or one major and two minor factors listed below, for more than one week and less than 4 weeks: \n\n Major factors: \n\n Facial pressure and/or pain \n\n Facial congestion or fullness \n\n Nasal obstruction \n\n Nasal purulence or postnasal discharge \n\n Hyposmia or anosmia \n\n Fever \n\n Minor factors: \n\n Headache \n\n Halitosis \n\n Fatigue \n\n Dental pain \n\n Cough \n\n Ear pain, pressure or fullness \n\n ", - "exclusion_criteria": ": \n\n General Conditions \n\n Subjects presenting with any of the following will not be included in the study: \n\n Treatment required during the study with ergot alkaloid derivatives, pimozide, astemizole, terfenadine, cisapride, simvastatin, atorvastatin and lovastatin, and the oral use of the benzodiazepines midazolam, triazolam and alprazolam. \n\n History of congenital or family history of long QT syndrome (if not excluded by ECG) or known acquired QT interval prolongation. \n\n Known hypersensitivity to telithromycin or to macrolide antibiotics. \n\n Hospital acquired infections (hospitalization for more than 72 hours within 7 days of study entry). \n\n Pregnant or breast-feeding women. For the women of childbearing potential it is left to the investigators discretion to establish a lack of pregnancy, e.g. with contraceptive use, menstrual pattern, urinary pregnancy test. \n\n Subjects with severely impaired renal function (creatinine clearance <30 ml/min). \n\n Subjects that had received anti-bacterials for more than 24 hours within 7 days prior to enrollment in the study, unless the treatment has failed. \n\n Subjects receiving medications, including other anti-microbials or anti-cancer drugs, that could interfere with the evaluation. \n\n Microbiologically documented infection with a pathogen known prior to inclusion to be resistant to the study medications. \n\n Infection, other than the primary infection for which the subject is being included in the study that requires use of other systemic anti-bacterial drug. \n\n Splenectomised subjects. \n\n Use of Ketek\u00ae (telithromycin) or participation in a study using Ketek\u00ae (telithromycin) in the previous 30 calendar days. \n\n Subjects that have received any investigational drug within 4 weeks of enrollment in the study. \n\n No subject will be allowed to enroll in this study more than once. \n\n For CAP \n\n Additional ", - "brief_summary": "Primary Objectives:~The primary objective of the study is to evaluate clinical efficacy i.e. to show that with respect to clinical cure rate, Ketek\u00ae (telithromycin) in the treatment of community acquired respiratory tract infections: community acquired pneumonia (CAP), acute bacterial exacerbation of chronic bronchitis (AECB) and acute sinusitis (AS), in outpatients.~Secondary Objectives:~The secondary objectives are to:~Further assess the efficacy of Ketek\u00ae (telithromycin) by considering the rate at which additional antibacterials were prescribed to treat the primary infection; the rate of hospitalisation due to a complication of the primary infection and assessment of bacteriological data, chest X-ray and sinus X-ray if available.~Evaluate safety of Ketek\u00ae (telithromycin) through Adverse Event (AE) and Serious Adverse Event (SAE) reporting", - "NCTID": "NCT00261105" - }, - { - "brief_title": "NO Donors and Inhibitors to Study Imbalance of Nitrogen Stress and Antioxidant Defense in COPD", - "phase": "", - "drugs": "['Aminoguanidine', 'Placebos']", - "drugs_list": [ - "Aminoguanidine", - "Placebos" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy non-smokers \n\n Normal spirometry (FEV1 >90 % predicted; exhaled NO bigger than or equal to 10 ppb; flow 50 ml/s) \n\n At risk (current smokers) \n\n Normal spirometry, with or without chronic symptoms (cough, sputum production) \n\n FEV1 reversibility of <15% after inhaled beta2-agonists* \n\n Moderate COPD \n\n FEV1 greater than or equal to 30% and < 80% \n\n FEV1/FVC < 70% predicted \n\n FEV1 reversibility of <15% after inhaled beta2-agonists \n\n With or without chronic symptoms (cough, sputum production, dyspnea) \n\n Able to comprehend and grant a written informed consent \n\n ", - "exclusion_criteria": ": \n\n Concomitant use or pre-treatment within the last 4 weeks with oral steroids \n\n Respiratory infection within 4 weeks prior to entry into the trial \n\n Females who are pregnant or lactating \n\n History of current or past drug or alcohol abuse", - "brief_summary": "The primary aim of this study is to investigate the effects of oral and inhaled administration of L-arginine and of inhaled aminoguanidine on bronchial and alveolar exhaled NO and NO metabolites in exhaled breath condensate, induced sputum, nasal lavage and mouth wash fluid in healthy non-smokers, current smokers and patients with COPD.", - "NCTID": "NCT00180635" - }, - { - "brief_title": "The International Nocturnal Oxygen (INOX) Trial", - "phase": "", - "drugs": "['Concentrator', 'Sham concentrator']", - "drugs_list": [ - "Concentrator", - "Sham concentrator" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease', 'Nocturnal Desaturation']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease", - "Nocturnal Desaturation" - ], - "enrollment": "243.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with a diagnosis of COPD supported by a history of past smoking and obstructive disease: FEV1<70% predicted, FEV1/FVC<70% and a total lung capacity by body plethysmography >80% predicted; \n\n Stable COPD at study entry, as demonstrated by (1) no acute exacerbation and (2) no change in medications for at least 6 weeks before enrollment in the trial; \n\n Non-smoking patients for at least 6 months before enrollment in the trial; \n\n SpO2 at rest < 95%; \n\n Patients fulfilling the current definition of nocturnal oxygen desaturation, i.e., >=30% of the recording time with transcutaneous arterial oxygen saturation <90% on at least one of two consecutive recordings; \n\n Ability ot give informed consent. \n\n ", - "exclusion_criteria": ": \n\n Patients with severe hypoxemia fulfilling the usual criteria for continuous oxygen therapy at study entry: PaO2 <=55 mmHg; or PaO2 <= 59 mmHg with clinical evidence of at least one of the following: (1) with right ventricular hypertrophy (P pulmonale on ECG:3 mm leads ll, lll, aVf); (2) right ventricular hypertrophy; (3)Peripheral edema (cor pulmonale); (4) hematocrit >=55%; \n\n Patients with proven sleep apnea (defined by an apnea/hypopnea index of >=15 events/hour) or suspected sleep apnea on oximetry tracings; \n\n Patients currently using nocturnal oxygen therapy; \n\n Patients with known left heart or congenital heart diseases, interstitial lung diseases, bronchiectasis as the main cause of obstructive disease, lung carcinoma, severe obesity (body mass index >= 40 kg/m\u00b2), or any other disease that could influence survival.", - "brief_summary": "This multicenter randomized placebo controlled trial aims to determine if in patients with COPD not qualifying for LTOT but presenting significant nocturnal arterial oxygen desaturation, whether nocturnal oxygen therapy provided for a period of 4 years decreases mortality or delay the prescription of LTOT.", - "NCTID": "NCT01044628" - }, - { - "brief_title": "Biomarker Assay Validation in Healthy Smokers and COPD Smokers and Ex-smokers", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['COPD', 'Asthma']", - "diseases_list": [ - "COPD", - "Asthma" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria for Healthy Smoking Subjects \n\n Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. \n\n Be between 18 and 75 years of age, inclusive, at informed consent. \n\n Healthy as determined by a physician, based on medical history and physical examination. \n\n Must have smoked regularly in the 12-month period preceding the screening visit and have a pack history of \u2265 5 pack years (number of pack years = number of cigarettes per day/20 x number of years smoked). \n\n inclusion criteria for All COPD Subjects \n\n Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. \n\n Aged between 40 and 75 years of age inclusive, at the time of signing the informed consent. \n\n COPD diagnosis: Subjects with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines (Celli, 2004). Symptoms must be compatible with COPD for at least 1 year prior to screening and post-bronchodilator spirometry readings at screening: \n\n Post-bronchodilator FEV1/FVC ratio of <0.7 \n\n Post-bronchodilator FEV \u226540 % and \u226480 % of predicted normal values calculated using NHANES reference equations. \n\n Additional Inclusion for Smoking COPD Subjects 1. Must have smoked regularly in the 12-month period preceding the screening visit and have a pack history of \u2265 5 pack years (number of pack years = number of cigarettes per day/20 x number of years smoked). \n\n ", - "exclusion_criteria": " for Healthy Smoking Subjects Any potential subject who meets any of the following criteria will be excluded from the participating study. \n\n Upper or lower respiratory tract infection within 4 weeks of the screening visit. \n\n Positive test for alcohol at screening. \n\n Taking prescription medication in the 14 days before screening. \n\n Subjects whose primary consumption of tobacco is via methods other than cigarettes (manufactured or self-rolled). Primary methods of tobacco consumption that are excluded include, but are not limited to pipes, cigars and e-cigarettes. \n\n Subjects who are unable to produce a total weight of at least 0.1 grams (g) of selected sputum at screening \n\n Urinary cotinine levels at screening < 30 ng/ml. \n\n Subject is mentally or legally incapacitated. \n\n Subject is an employee of the Sponsor or contract research organization (CRO), or a relative of an employee of the Sponsor or CRO. \n\n Any other reason that the Investigator considers makes the subject unsuitable to participate. \n\n ", - "brief_summary": "This study will collect sputum samples from healthy smokers, COPD smokers and COPD ex-smokers to analyse biomarkers of inflammation", - "NCTID": "NCT02490358" - }, - { - "brief_title": "NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "400.0", - "inclusion_criteria": "inclusion criteria \n\n Participants must meet all of the following criteria for enrollment: \n\n Male or female, 18 to 60 years of age \n\n Must have clinical evidence of moderate-severe atopic asthma: \n\n self-reported symptoms suggestive of asthma (such as wheezing, chest tightness, shortness of breath, cough nocturnal symptoms) \n\n within the past year, and \n\n --*a positive methacholine test confirming diagnosis [provocative concentration causing a 20% fall in forced expiratory volume in 1 second (PC20 FEV1) <16 mg/mL for participants on inhaled corticosteroids and <8 mg/mL for participants not on inhaled corticosteroids] or postbronchodilator FEV1 with at least 12% or 200 mL increase in FEV1 or forced volume vital capacity (FVC) on bronchodilator challenge, and \n\n --no other diagnosis that could explain symptoms. \n\n If there is documentation of a recent methacholine challenge, those results may be used in lieu of conducting a secondary methacholine challenge. \n\n Permanently resides within 50 miles of the CRU. \n\n Able to present a valid government issued form of identification for entry to the NIEHS campus \n\n Able to receive asthma treatment medication(s) via mail \n\n Willingness to comply with instructions regarding medication regimen, diet, and life style as directed by the investigator that are required per protocol \n\n Access to a vacuum cleaner with a detachable hose component \n\n If a woman is found to be pregnant or breastfeeding at the screening or baseline visit, they may continue their participation in the study but will be excluded from participation in the methacholine challenge and bronchoscopy procedures in this study while pregnant. \n\n Bronchoscopy Visit Inclusion Criterion \n\n In addition to the above inclusion criteria, participants must be able to fast for 6 hours (no food or drink, except a small amount of water if needed to take approved medications) prior to the bronchoscopy visit in order to be eligible for enrollment in the bronchoscopy visit. \n\n ", - "exclusion_criteria": " \n\n Participants meeting any of the following criteria at screening will not be eligible for enrollment or to continue with study visits: \n\n Current smoker, significant second-hand smoke exposure (defined by urine cotinine >200 ng/mL at screening), or a history of smoking greater than 5 pack years. Smoking encompasses all inhaled products, including e-cigarettes. \n\n piCO Smokealyzer value of >11ppm \n\n History of the following comorbidities: chronic obstructive pulmonary disease, cystic fibrosis (CF), emphysema, non-CF bronchiectasis, pulmonary fibrosis, sarcoidosis, unstable angina, pulmonary hypertension \n\n Allergy or history of adverse reactions to methacholine \n\n Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures \n\n Comorbid diseases that affect global health or survival- such as DVT, pulmonary embolism, class III - IV congestive heart failure, or a malignancy under treatment \n\n Bronchoscopy Visit ", - "brief_summary": "Background:~- Asthma is a serious clinical and public health problem. Researchers want to collect data to better understand how bacteria and other things in the environment can affect people's asthma.~Eligibility:~- Nonsmoking adults age 18 - 60 who have moderate to severe asthma and are not pregnant or breastfeeding.~Design:~Partaicipants will complete a medical history form before the first visit.~Study visits will include collecting medical history, and conducting physical exam, lung and smoking tests. Participants will give blood, urine, stool, dust, saliva, and sputum samples.~Participants will take tests that measure their breathing abilities. They will give saliva samples for DNA study. They will get kits to collect stool and dust samples at home. They will fill out surveys.~Participants will have visits every 6 months for 5 years. They can schedule sick visits, if needed, at no cost to the participant. For all visits, they will have asthma check-ups and get treatment, at no cost to the participant.~Some participants may take part in a sub-study that includes one 4-hour visit. They will have medical history, physical exam, and lung tests. They will have urine tests to check for pregnancy and tobacco exposure. Then they will have bronchoscopy. For this, an intravenous line will be placed in an arm vein. The nose and throat will be numbed. A flexible fiber-optic tube will be inserted into their airways through the nose. Their airways will be examined and areas of their lung will be washed. A small sample of cells will be taken.", - "NCTID": "NCT02327897" - }, - { - "brief_title": "Effect of a 10,000 EU Dose of Endotoxin in Allergic and Mildly Asthmatic Adults", - "phase": "Phase 1", - "drugs": "['Clinical Center Reference Endotoxin (CCRE)']", - "drugs_list": [ - "Clinical Center Reference Endotoxin (CCRE)" - ], - "diseases": "['Rhinitis, Allergic, Perennial', 'Rhinitis, Allergic, Seasonal', 'Asthma']", - "diseases_list": [ - "Rhinitis", - "Allergic", - "Perennial", - "Rhinitis", - "Allergic", - "Seasonal", - "Asthma" - ], - "enrollment": "11.0", - "inclusion_criteria": "inclusion criteria: \n\n inclusion criteria \n\n Specific allergy to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response. \n\n FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .75 (without use of bronchodilating medications for 12 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma. \n\n History of nasal allergy, including episodic, perennial, or seasonal sneezing, nasal congestion or cough, or such symptoms associated with specific exposures (such as cat or dog) \n\n Criteria for classification as having asthma with allergic rhinitis vs. allergic rhinitis alone: \n\n History of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician diagnosed asthma. \n\n Provocative concentration of methacholine producing a 20% fall in FEV1 (PC20 methacholine) of less than 10 mg/ml by the method used (see below). \n\n ", - "exclusion_criteria": ": \n\n Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, or chronic thyroid disease. \n\n Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months. \n\n Use of systemic steroid therapy within the preceding 12 months for an asthma exacerbation. All use of systemic steroids in the last year will be reviewed by a study physician. \n\n Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or zafirkulast) initiated within the past month (except for use of cromolyn exclusively prior to exercise). Patients must be on a stable regimen of therapy and shown to be stable. \n\n Use of daily theophylline within the past month. \n\n Pregnancy or nursing a baby. \n\n Cigarette smoking > 1 pack per month. \n\n Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. \n\n Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. \n\n Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to include prophylactic use of albuterol prior to exercise). \n\n Dosing level of an inhaled steroid must be consistent with mild episodic asthma as outlined by the NHLBI NAEPP guidelines. Any dose of inhaled steroid typically used for moderate or severe asthma will result in exclusion from the protocol. \n\n Viral upper respiratory tract infection within 2 weeks of challenge. \n\n Any acute infection requiring antibiotics within 2 weeks of challenge.", - "brief_summary": "The purposes of this pilot safety study are to identify a dose of inhaled Clinical Center Reference Endotoxin (CCRE) that is well tolerated by allergic subjects that induces measurable increases in neutrophil content of induced sputum that can be employed to screen large populations for susceptibility to the inflammatory effect of inhaled endotoxin.", - "NCTID": "NCT00839189" - }, - { - "brief_title": "Prospective Validation of Cough, Dyspnea, and Quality of Life Questionnaires in Patients With IPF", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Interstitial Lung Disease', 'Idiopathic Pulmonary Fibrosis']", - "diseases_list": [ - "Interstitial Lung Disease", - "Idiopathic Pulmonary Fibrosis" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Completion of informed consent. \n\n Adults over the age of 18. \n\n Diagnosis of IPF per ATS guidelines. \n\n Clinically stable at the time of enrollment defined as no antibiotics within the past month, with the exception of those patients currently listed for Lung Transplantation. \n\n No changes in immunosuppressive regimens (if applicable) over past month. \n\n ", - "exclusion_criteria": ": \n\n Inability to understand or complete paper and pencil questionnaires. \n\n Patient not planning to return to Stanford for clinic visits.", - "brief_summary": "The purpose of this study is to test cough, dyspnea (shortness of breath), and quality of life (QOL) questionnaires for their accuracy, sensitivity, and ability to reliably measure the severity of cough, breathlessness, and changes in cough and disease-related quality of life over time in Idiopathic Pulmonary Fibrosis (IPF) patients. These questionnaires have been used in other types of disease, but have not all been tested and validated in patients with cough due to IPF. Our hypothesis is that worsening of cough, dyspnea, and cough-related QOL questionnaire scores will correlate with physiologic markers of IPF severity and worsening of disease. Written, valid questionnaires measuring cough, dyspnea, and QOL are important to assess the benefit of investigational drugs under development to treat patients with IPF.", - "NCTID": "NCT01874223" - }, - { - "brief_title": "Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Asthma', 'Bronchiolitis']", - "diseases_list": [ - "Asthma", - "Bronchiolitis" - ], - "enrollment": "45.0", - "inclusion_criteria": "inclusion criteria: \n\n patient is admitted to the ER with shortness of breath \n\n patient management is according to standardized protocols used in Hadassah Mt. Scopus pediatric emergency department including: \n\n asthma management protocol \n\n bronchiolitis management protocol \n\n ages 0 - 15 \n\n patient's parent/guardian is able to comprehend and give informed consent for participating in the study \n\n ", - "exclusion_criteria": ": \n\n patient has received any dose of inhaled bronchodilators in the hour prior to enrollment \n\n patient has received oral or IV steroids in a time window of 30 minutes to 5 hours prior to enrollment \n\n ventilated patients, while ventilated \n\n chest skin lesions \n\n cystic fibrosis \n\n hemodynamic instability \n\n patient's parent/guardian objects to the study protocol \n\n concurrent participation in any other clinical study \n\n physician objection", - "brief_summary": "Phenotype characterization of shortness of breath of pediatric emergency room patients by objective wheeze and cough monitoring improves diagnostic and severity assessment accuracy and correlates with overall patient outcomes.", - "NCTID": "NCT01414322" - }, - { - "brief_title": "The Short-term Effect of ELTGOL on Pulmonary Ventilation Valued Through Electrical Impedance Tomography in Cystic Fibrosis Patients", - "phase": "", - "drugs": "['ELTGOL', 'Acapella']", - "drugs_list": [ - "ELTGOL", - "Acapella" - ], - "diseases": "['Cystic Fibrosis']", - "diseases_list": [ - "Cystic Fibrosis" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: Volunteers with Cystic Fibrosis and lung disease with chest hemiper\u00edmetro \u2265 37 cm. ", - "exclusion_criteria": ": Episode of pulmonary infectious exacerbations in the last four weeks or during the study period; cor pulmonale; facial deformity that causes air leakage; facial trauma and recent face or esophagus surgery; chest pain; hemoptysis in the last week; continued use of supplemental oxygen (> 8 hours / day); hemoptysis; hemodynamic instability and do not understand the use and command of the techniques used.", - "brief_summary": "Cystic Fibrosis (CF) is the most common lethal autosomal recessive disease. Respiratory therapy is always recommended to the CF patient with pulmonary involvement and has differents techniques and devices, however, there is no consensus on the effectiveness of the techniques used, there is a need to determine the applicability of the therapeutic resources used. Therefore, the aim of the study is to determine the short-term effectiveness of ELTGOL on Average Electrical Impedance on the End of Expiration (MIEFE) pulmonary, assessed by Electrical Impedance Tomography (EIT) in individuals with CF through a clinical trial randomized crossover. Volunteers will be included with FC with moderate to severe lung disease with chest \u2265 74 cm that do not show: episode of pulmonary infectious exacerbations in the last four weeks or during the study period; cor pulmonale; facial deformity that causes air leakage; facial trauma and recent face or esophagus surgery; chest pain; hemoptysis in the last week; continued use of supplemental oxygen (> 8 hours / day); hemoptysis; hemodynamic instability and do not understand the use and command of the techniques used. The sample is selected by convenience from the database of individuals assisted data in Integrative Medicine Institute Professor Fernando Figueira (IMIP). The research will be developed in three phases, divided into three days with an interval of at least 48 hours between phases. The first day will undergo initial assessment and in the days following the intervention by day, ELTGOL or Acapella, in a randomized order.", - "NCTID": "NCT02600039" - }, - { - "brief_title": "Exhaled NO Testing in Filariasis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Filariasis']", - "diseases_list": [ - "Filariasis" - ], - "enrollment": "96.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 6 years or older of either gender \n\n Patients presenting with pulmonary symptoms a. Confirmed or suspected asthma patients: i. Patients presenting with symptoms consistent with an acute exacerbation of asthma, including: \n\n 1. Wheezing 2. Shortness of breath 3. Chest tightness 4. Cough ii. Disposition to the asthma room after triage and physician evaluation (disposition to other areas of the A&E allowed if due to no available space in the asthma room) iii. Patients are potentially eligible with or without a past history of health care provider diagnosed asthma iv. Patients are potentially eligible regardless of the number of previous episodes of wheezing (i.e. patients with a first episode of bronchospasm are potentially eligible) v. If suspected or documented to have pneumonia or a pulmonary infiltrate, patients are potentially eligible if: \n\n They have a dry cough (no production of purulent sputum) \n\n They have bronchospasm as manifested by wheezing or need for salbutamol (albuterol) breathing treatments vi. Patients with wheezing are not eligible if they: \n\n 1. Have purulent sputum production 2. Have known or suspected: \n\n a. Tuberculosis b. Immunodeficiency c. Congestive heart failure d. Foreign body aspiration b. Patients presenting with a chief complaint of cough: i. Potentially eligible patients will have a cough of greater than one week (seven days) duration ii. Asthma room disposition is not required for these subjects iii. If suspected or documented to have pneumonia or a pulmonary infiltrate, patients are potentially eligible if: \n\n 1. They have a dry cough (no production of purulent sputum) iv. Patients with cough are not eligible if: \n\n Have purulent sputum production \n\n Have known or suspected: \n\n Tuberculosis \n\n Immunodeficiency \n\n Congestive heart failure \n\n Foreign body aspiration \n\n Patients will be medically stable at the time of the consent process (see ", - "exclusion_criteria": " below) \n\n A minimum of 2 years of continuous residence in Guyana at the time of enrollment, exclusive of short trips out of the country (at least 21 of previous 24 months physically in Guyana) \n\n English speaking \n\n ", - "brief_summary": "This study is looking at the difference in exhaled nitric oxide levels in patients with and without laboratory evidence of filariasis.", - "NCTID": "NCT01628497" - }, - { - "brief_title": "Asthma Severity in Children and Environmental Agents", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "", - "inclusion_criteria": "Siblings of a birth cohort recruited 1997-1999 \n\n Age less than 11 years \n\n Physician diagnosed asthma \n\n Active symptoms (wheeze, persistent cough, chest tightness, shortness of breath) or medication use in the 12 months prior to enrollment.", - "exclusion_criteria": "", - "brief_summary": "This study measures residential exposures (indoor allergens, mold, nitrogen dioxide, nicotine) and relates exposure levels to daily symptoms (wheeze, persistent cough, chest tightness, shortness of breath) and medication use, in a population of children with physician diagnosed asthma, followed for 12 months.", - "NCTID": "NCT00042705" - }, - { - "brief_title": "Reduced Contractile Reserve: a Therapeutic Target in Heart Failure With Preserved Ejection Fraction(HFpEF)", - "phase": "", - "drugs": "['Dobutamine', 'Amlodipine']", - "drugs_list": [ - "Dobutamine", - "Amlodipine" - ], - "diseases": "['Heart Failure With Preserved Ejection Fraction', 'Pulmonary Disease', 'Left Ventricular Hypertrophy/Hypertension']", - "diseases_list": [ - "Heart Failure With Preserved Ejection Fraction", - "Pulmonary Disease", - "Left Ventricular Hypertrophy/Hypertension" - ], - "enrollment": "14.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female; Age 18 or older. \n\n Left ventricular ejection fraction \u2265 50%. \n\n Symptomatic heart failure or appropriate comparator group criteria \n\n Informed consent signed by the subject \n\n ", - "exclusion_criteria": ": \n\n Symptoms of active ischemia. \n\n Moderate or severe mitral or aortic stenosis, or severe aortic insufficiency. \n\n Serum creatinine > 3.0 or chronic hemodialysis. \n\n Known chronic hepatic disease; defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels > 3.0 times the upper limit of normal as read at the local lab. \n\n Severe renal dysfunction, i.e. glomerular filtration rate (GFR) <30 ml/min. \n\n Atrial fibrillation \n\n Myocardial infarction within the last year \n\n Coronary bypass surgery within the last 6 months \n\n Stroke within the last 6 months \n\n Known aortic aneurysm \n\n Contra-indication to withdrawal of beta blocker or antihypertensive medications \n\n Resting or orthostatic hypotension (SBP < 90 mmHg) \n\n Any gastrointestinal disorder which would interfere with drug absorption \n\n Any significant valvular heart disease, including prior multiple valve replacement. \n\n Pericardial Disease \n\n Infiltrative or hypertrophic cardiomyopathy \n\n Cor pulmonale \n\n Unstable coronary disease \n\n Pregnancy \n\n Any condition which may prevent the subject from adhering to the study protocol, as determined by the investigator \n\n Heart Failure with Preserved Ejection Fraction \n\n Clinical evidence of heart failure with preserved ejection fraction, as manifest by at least 2 symptoms or signs, including dyspnea on exertion or at rest, orthopnea, jugular venous distention or hepatojugular reflux, rales or edema. \n\n Controlled systolic BP (< 150 mmHg on the day of study) \n\n Pulmonary Disease Group \n\n Known obstructive airways disease with objective documentation of an isolated obstructive defect by pulmonary function testing. \n\n No history of heart failure. \n\n No history of cardiovascular disease, with the exception of hypertension or hyperlipidemia \n\n History and physical examination free of signs and symptoms of heart failure, including elevated jugular venous pressure, hepatojugular reflux, rales or edema. \n\n Baseline echocardiographic examination without evidence of heart failure, including systolic dysfunction of the LV or RV, or evidence of more than mild diastolic dysfunction on non-invasive assessment. \n\n HTN/LVH Group \n\n Known history of hypertension. \n\n Echocardiographic evidence of left ventricular hypertrophy and diastolic dysfunction. \n\n No history or physical examination evidence of heart failure, including excessive dyspnea on exertion, dyspnea at rest, orthopnea, PND, jugular venous distention, hepatojugular reflux, rales or edema.", - "brief_summary": "Heart failure with preserved ejection fraction (HFpEF) accounts for over 50% of heart failure cases in the United States, affecting a primarily elderly population. No treatment has been shown to affect mortality in HFpEF, which is more than 50% at five years a hospitalization. This project explores the underlying cardiovascular physiology of patients with HFpEF with the goal of identifying new therapeutic targets that would allow improved treatment of this devastating disease.", - "NCTID": "NCT01354613" - }, - { - "brief_title": "A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma", - "phase": "Phase 3", - "drugs": "['Levalbuterol', 'Levalbuterol UDV TID', 'Placebo']", - "drugs_list": [ - "Levalbuterol", - "Levalbuterol UDV TID", - "Placebo" - ], - "diseases": "['Asthma']", - "diseases_list": [ - "Asthma" - ], - "enrollment": "197.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject's parent/legal guardian must give written informed consent, including privacy authorization, prior to study participation. Complete documentation regarding the consent process must be recorded in the case report form (CRF) and source documentation. \n\n Subject's parent/legal guardian must be willing and able to comply with the study procedures and visit schedules. \n\n Subject, male or female, must be between the ages of birth and <48 months, exclusive, at the time of consent. \n\n Subjects 24 to <48 months of age must have a history of physician-diagnosed asthma (defined as at least 3 episodes of respiratory symptoms consistent with asthma symptoms including, but not limited to, cough, wheeze, or dyspnea). \n\n Subjects 0 to <24 months of age must have a history of 3 episodes of respiratory symptoms that in the judgement of the investigator could be consistent with asthma or reactive airways disease. \n\n Subject must be in good health and not affected by any other chronic conditions, including respiratory disorders other than asthma. \n\n In subjects with a chest radiograph (taken 12 months prior to screening visit), no evidence of any chronic cardiopulmonary condition other than asthma should be present as discerned by the Investigator. \n\n Subject's parent/legal guardian must be able to complete the diary cards and medical event calendars (MEC) reliably on a daily basis and understand dosing instructions and questionnaire completion. \n\n ", - "exclusion_criteria": ": \n\n Subject who requires or is expected to require any disallowed medications \n\n Subject who has participated in an investigational drug study within 30 days prior to screening, or who is currently participating in another clinical trial. \n\n Subject or parent/legal guardian who has daily commitments during the study that would interfere with trial measurements, compliance, or both. \n\n Subject who has a history of hospitalization for asthma, reactive airways disease, or bronchospasm within 4 weeks prior to screening or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial. \n\n Subject who has experienced significant blood loss within 60 days of study drug. \n\n Subject with a clinical diagnosis of cystic fibrosis. \n\n Subject who was born prematurely, defined as less than 38 weeks gestational age at birth, and is <1 year of age at screening \n\n Subject whose body weight is less than 7.0 kg at screening. This minimum weight requirement is based upon standard pediatric growth charts [CDC 2000]. \n\n Subject with a known sensitivity to levalbuterol or racemic albuterol, or any of the excipients contained in any of these formulations. \n\n Subject using any prescription drug with which levalbuterol or racemic albuterol sulfate administration is contraindicated. \n\n Subject with a history of life-threatening asthma, defined as previous asthma episodes requiring intubation or associated with hypercapnia, respiratory arrest, or hypoxic seizures. \n\n Subject with clinically significant abnormalities that may interfere with the metabolism or excretion of the study drugs or study participation (eg, abnormalities of renal, hepatic, metabolic, or endocrine function). \n\n Subject with a history of cancer. \n\n Subject with any chronic or congenital cardiorespiratory condition other than asthma including, but not limited to, bronchopulmonary dysplasia, congenital heart disease, and cystic fibrosis. \n\n Subject affected by an upper or lower respiratory tract infection in the 3 weeks prior to screening. \n\n Subject with a history of ventilation for a respiratory condition occurring at or near birth, including those associated with prematurity or bronchopulmonary dysplasia. Ventilatory support for elective non-cardiopulmonary surgery is not exclusionary. - Subject with any clinically significant abnormal laboratory values (hematology, blood chemistry). \n\n Subject with a clinically significant abnormal 12-lead ECG that would put the subject at risk for experiencing adverse cardiac effects. \n\n Subject who is a relative of a staff member.", - "brief_summary": "A Safety, Efficacy, and Tolerability Study of Daily Dosing with Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to <48 Months with Asthma.", - "NCTID": "NCT00809757" - } - ], - "1": [ - { - "brief_title": "Effects of Bronchodilators in Mild Chronic Obstructive Pulmonary Disease (COPD)", - "phase": "Phase 4", - "drugs": "['Ipratropium Bromide']", - "drugs_list": [ - "Ipratropium Bromide" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease (COPD)']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease (COPD)" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n diagnosis of mild COPD OR healthy control subjects \n\n 40-80 years old \n\n able to perform all study procedures \n\n Smoking history > 10 pack years (for mild COPD) or smoking history < 10 pack years (for healthy control subjects) \n\n ", - "exclusion_criteria": ": \n\n allergy to atrovent \n\n history of asthma, atopy or nasal polyps \n\n Oxygen desaturation < 80 % during exercise \n\n recent history of CAD (under a year) or any significant diseases that could contribute to dyspnea or exercise limitation", - "brief_summary": "In people with mild COPD, the ability to exhale air from the lungs is partly limited because of narrowing and collapse of the airways. This results in the trapping of air within the lungs and over-distention of the lungs and chest (lung hyperinflation).~Breathing at high lung volumes (hyperinflation) is an important cause of breathing discomfort (dyspnea) in people with COPD. Bronchodilators help to relax muscles in the airways or breathing tubes. Bronchodilators are often prescribed if a cough occurs with airway narrowing as this medication can reduce coughing, wheezing and shortness of breath. Bronchodilators can be taken orally, through injection or through inhalation and begin to act almost immediately but with the effect only lasting 4-6 hours. The main purpose of this study is to examine the effects of inhaled bronchodilators on breathing discomfort and exercise endurance in patients with mild COPD.", - "NCTID": "NCT00202176" - }, - { - "brief_title": "PROCHYMAL\u2122 (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)", - "phase": "Phase 2", - "drugs": "['Prochymal\u2122', 'Placebo']", - "drugs_list": [ - "Prochymal\u2122", - "Placebo" - ], - "diseases": "['Pulmonary Disease, Chronic Obstructive', 'Pulmonary Emphysema', 'Chronic Bronchitis']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive", - "Pulmonary Emphysema", - "Chronic Bronchitis" - ], - "enrollment": "62.0", - "inclusion_criteria": "inclusion criteria: \n\n Participant must have a diagnosis of moderate or severe COPD. \n\n Participant must have a post-bronchodilator FEV1/forced vital capacity (FVC) ratio < 0.7. \n\n Participant must have a post-bronchodilator FEV1 % predicted value \u2265 30% and < 70%. \n\n Participant must be between 40 and 80 years of age, of either sex, and of any race. \n\n Participant must be a current or ex-smoker, with a cigarette smoking history of \u2265 10 years or > 10 pack-years. \n\n ", - "exclusion_criteria": ": \n\n Participant has been diagnosed with asthma or other clinically relevant lung disease other than COPD (e.g. restrictive lung diseases, sarcoidosis, tuberculosis, idiopathic pulmonary fibrosis, bronchiectasis, or lung cancer). \n\n Participant has been diagnosed with \u03b11-antitrypsin deficiency. \n\n Participant has a body mass greater than 150 kg (330 lb) or less than 40 kg (88 lb). \n\n Participant has active infection. \n\n Participant has had a significant exacerbation of COPD or has required mechanical ventilation within 4 weeks of screening. \n\n The participant with clinically relevant uncontrolled medical condition not associated with COPD. \n\n Participant has documented history of uncontrolled heart failure. \n\n Participant has pulmonary hypertension due to left heart condition. \n\n Participant has atrial fibrillation or significant congenital heart defect/disease. \n\n Participant has initiated pulmonary rehabilitation within 3 months of screening. \n\n Participant is allergic to bovine or porcine products. \n\n Participant has evidence of active malignancy, or prior history of active malignancy that has not been in remission for at least 5 years. \n\n Participant has a life expectancy of < 6 months.", - "brief_summary": "The objective of the present study is to establish the safety and efficacy of multiple administrations of Prochymal\u2122(ex-vivo cultured human adult mesenchymal stem cells) in participants with moderate to severe chronic obstructive pulmonary disease (COPD).", - "NCTID": "NCT00683722" - }, - { - "brief_title": "Genetic Mechanisms of Chronic Obstructive Pulmonary Disease (COPD)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Lung Disease']", - "diseases_list": [ - "Chronic Obstructive Lung Disease" - ], - "enrollment": "", - "inclusion_criteria": "Age greater than or equal to 40 years \n\n Cigarette smoking greater than or equal to 30 pack years \n\n Obstructive Spirometry \n\n First degree relative with smoking history willing to participate", - "exclusion_criteria": "", - "brief_summary": "The purpose of this study is to determine whether genetic factors contribute to an individuals risk of developing obstructive lung disease from smoking cigarettes.", - "NCTID": "NCT00018408" - }, - { - "brief_title": "Osteoporosis and Chronic Obstructive Pulmonary Disease (COPD)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['COPD', 'Osteoporosis', 'Osteopenia']", - "diseases_list": [ - "COPD", - "Osteoporosis", - "Osteopenia" - ], - "enrollment": "250.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 18 years \n\n Men and women \n\n COPD according to the ATS-guidelines, divided in severity according to the GOLD criteria \n\n Written consent \n\n ", - "exclusion_criteria": ": \n\n Age < 18 years \n\n No written consent", - "brief_summary": "The goals of the trial are:~To determine the prevalence of osteoporosis in subgroups of COPD patients.~To look for risk factors of osteoporosis in COPD patients.~To create sub-groups for prospective research concerning the effects of bisphosphonates on osteoporosis variables in COPD patients.", - "NCTID": "NCT00231127" - }, - { - "brief_title": "Interaction in Chronic Obstructive Pulmonary Disease Experiment", - "phase": "", - "drugs": "['Tiotropium (Spiriva) + Salbutamol (Ventolin)', 'placebo']", - "drugs_list": [ - "Tiotropium (Spiriva) + Salbutamol (Ventolin)", - "placebo" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease', 'Cardiovascular Disease', 'Smoking', 'Bronchodilation']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease", - "Cardiovascular Disease", - "Smoking", - "Bronchodilation" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n COPD Gold stage II-III (FEV1/FVC<0,70 and FEV1 30-80% of predicted value). \n\n Current cigarette smoking (at the time of performing the study). \n\n Willing to provide written informed consent. \n\n Refrain from smoking and bronchodilators > 8 hours (depends on treatment) before the test. \n\n Registered in one of the recruitment institutes. \n\n ", - "exclusion_criteria": ": \n\n COPD gold stage I or IV. \n\n Asthmatic component: History of asthma, present asthma by complaints, eosinophilia or reversibility \u2265 10% of predicted. \n\n Unable to communicate. \n\n Physically unable to perform any of the tests. \n\n Non-COPD respiratory disorders. \n\n Previous lung-volume reduction surgery and/or lung transplantation. \n\n Evidence of alcohol, drug or solvent abuse. \n\n Known \u03b1-1 antitrypsin deficiency.", - "brief_summary": "The final purpose of this study is to determine whether bronchodilation and cigarette smoking in Chronic Obstructive Pulmonary Disease (COPD) patients interact, resulting in an increase of cardiovascular disease. The aim of this part of the study is to demonstrate the basic mechanism: Does increased respiratory function after administration of a bronchodilator in patients with COPD lead to elevated pulmonary retention of the harmful compounds in inhaled cigarette smoke and to short-term biological effects associated with cardiovascular disease?", - "NCTID": "NCT00981851" - }, - { - "brief_title": "Effects of Advair\u00ae in Outpatients With Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbation", - "phase": "Phase 3", - "drugs": "['prednisone group', 'Advair group']", - "drugs_list": [ - "prednisone group", - "Advair group" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease (COPD)']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease (COPD)" - ], - "enrollment": "14.0", - "inclusion_criteria": "inclusion criteria: \n\n diagnosis of COPD \n\n history of 15 pack-years or more of cigarette smoking \n\n evidence of irreversible obstruction (FEV1<70% of predicted value, ratio FEV1/FVC<70%, and improvement of FEV1of less than 20% after bronchodilator in previous respiratory tests done when they were stable) \n\n ", - "exclusion_criteria": ": \n\n history of asthma or atopy \n\n need of being hospitalized \n\n use of oral or intravenous steroid within the preceding 30 days \n\n history of multiresistant bacterial infection (not applicable if absence of multi-resistant bacterial infection has been proved by a negative expectoration culture in the previous 6 months), bronchiectasis or recent COPD exacerbation (< 6 weeks) or diabetes. \n\n oxygen-dependant COPD patients or patients previously known with hypercapnia (PCO2>45 mmHg) at steady state \n\n use of high doses of Advair (more than 50/500 bid) or Symbicort (more than 12/400 bid) \n\n known cardiac arrhythmia such as atrial fibrillation, supraventricular tachycardia or paroxysmal auricular tachycardia", - "brief_summary": "Short course of steroids in COPD exacerbation improves FEV1 and decreases the relapse rate. However, some concerns remain about using systemic steroids for all patients with acute exacerbation. Their short-term advantages may be outweighed by the occurrence of adverse side effects such as hyperglycemia, which is difficult to manage on an outpatient basis. In this context, the possibility of treating patients with COPD exacerbation with inhaled steroids having less systemic adverse effects is interesting. The objectives are to compare relapse rate, lung function, the severity of dyspnea and, systemic and sputum inflammatory markers in outpatients with acute COPD exacerbations treated with fluticasone/salmeterol (Advair\u00ae) or oral prednisone for 10 days. The hypothesis is that Advair\u00ae is as effective as prednisone in treatment of outpatients with COPD exacerbation. The primary endpoint is to determine if the relapse rate at one month is equivalent for both treatments. The secondary endpoints are to compare lung function and dyspnea score and, systemic and sputum inflammatory markers modulation after 10 days of both treatments. We will recruit 30 outpatients in each group from our COPD clinic. Patients will receive prednisone (40mg/day) with placebo diskus or Advair\u00ae 50/500ug 2 inhalations bid (twice the regular dose) with placebo pills for 10 days. All patients will receive antibiotics and short-acting bronchodilators as needed. We expect to demonstrate that the improvement of lung function, dyspnea, inflammatory markers and relapse rate are equivalent in both treatments suggesting that Advair\u00ae could be a good alternative to prednisone for patients with steroid-induced hyperglycemia.", - "NCTID": "NCT00531791" - }, - { - "brief_title": "Case Method Education on COPD to General Practitioners", - "phase": "", - "drugs": "['Case method education in COPD', 'Traditional education in COPD']", - "drugs_list": [ - "Case method education in COPD", - "Traditional education in COPD" - ], - "diseases": "['COPD']", - "diseases_list": [ - "COPD" - ], - "enrollment": "822.0", - "inclusion_criteria": "inclusion criteria: \n\n Primary Health Care Centers (PHCC): >10.000 patients listed. >70% permanent employed general practitioners \n\n Patients: Diagnosis of COPD registered at the COPD. Grade of COPD 2-3 (GOLD) at the latest spirometry completed since 2008. \n\n ", - "exclusion_criteria": ": \n\n None", - "brief_summary": "Background:~COPD is an inflammatory and chronic obstructive lung disease, mainly caused by smoking. Most patients with COPD are discovered and treated in primary health care. Co-morbidity with heart disease, hypertension, diabetes, osteoporosis and underweight is common. It is important to diagnose COPD at an early stage, primarily to motivate smoking cessation, which is the most important factor for decelerating the progress of COPD. In addition, medication and rehabilitation to reduce symptoms of COPD can be given. Previous studies in Sweden have shown poor quality of primary health care provided to patients with COPD.~As general practitioners often deal with multiple medical problems and patients' motivation when diagnosing and treating COPD we hypothesize that case method education (see description under intervention) in COPD has better effect than traditional education (see description under intervention).This study aims to examine the effect of case method education on (1) learning in COPD among general practitioners and on (2) health in their patients with COPD.~Method:~Primary health care centers (PHCC) in Stockholm will be recruited. The PHCCs will be randomized to either case method education (n=9 PHCCs) or traditional education (n=9 PHCCs) in COPD for their general practitioners. The educations will be held during two times (two hours each) within a time range of three months, covering examination and treatment of patients with COPD. At least 10.000 patients should be listed at PHCCs included. Random sampling of 45 patients with COPD at stage 2-3 will be done from each PHCC. The patients will fill in a self-assessment questionnaire including CCQ, CAT and LINQ (see outcome measures) as well as questions about medication, exacerbations and other chronic diseases. The questionnaire will be sent to the patients 1-2 months before the education and 18 months after the education. Differences in assessments in the questionnaire before and after the education will be compared between the patients listed at the PHCCs that have received case method education vs. traditional education. In addition, general practitioners (approximately, n=180) at the PHCCs will fill in a questionnaire, immediately before and 12 months after the education, covering the learning outcomes in order to study differences in learning between the two intervention groups.", - "NCTID": "NCT02213809" - }, - { - "brief_title": "Outcomes for Chronic Obstructive Pulmonary Disease Moderate Exacerbators Initiating Treatment", - "phase": "", - "drugs": "['Fluticasone Propionate / Salmeterol Xinafoate Combination (FSC)', 'Anticholinergics (AC)']", - "drugs_list": [ - "Fluticasone Propionate / Salmeterol Xinafoate Combination (FSC)", - "Anticholinergics (AC)" - ], - "diseases": "['Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "2849.0", - "inclusion_criteria": "inclusion criteria: \n\n minimum age 40 years at index \n\n continuously enrolled in health plan \n\n diagnosis of COPD (ICD-9 codes of 491, 492, 496) \n\n at least one moderate exacerbation event as defined previously. \n\n ", - "exclusion_criteria": " \n\n Exclusionary comorbid conditions of respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis (TB), bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary TB, or sarcoidosis \n\n Patients excluded if they did not receive treatment within the treatment assessment period following moderate exacerbation \n\n Receipt of maintenance medication in the pre-period \n\n Presence of treatment switch, discontinuation of index drug, or any COPD-related exacerbation during the treatment assessment period", - "brief_summary": "Patients with moderate COPD as defined by GOLD guidelines constitute almost 46% to 54% of all diagnosed COPD patients. Yet limited data exists on characterizing this study population in terms of drug therapy patterns and COPD-related resource use and costs. The objective of the following study was to conduct an analysis in the real-world setting to (1) identify and characterize COPD patients with moderate exacerbations and (2) evaluate the impact of initiating different maintenance therapies in this population. Maintenance therapy medications include inhaled corticosteroids (ICS), long-acting beta agonists (LABAs), combination of ICS+LABA, and anticholinergics (ACs) including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium [IPR]).", - "NCTID": "NCT01395875" - }, - { - "brief_title": "Effect of Traditional Chinese Medicine on Outcomes in Patients With Severe / Very Severe COPD", - "phase": "Phase 3", - "drugs": "['Salmeterol / fluticasone (Seretide\u00ae)', 'Bufeijianpi granule', 'Bufeiyishen granule', 'Yiqizishen granule', 'Placebo Bufeijianpi granule', 'Placebo Bufeiyishen granule', 'Placebo Yiqizishen granule']", - "drugs_list": [ - "Salmeterol / fluticasone (Seretide\u00ae)", - "Bufeijianpi granule", - "Bufeiyishen granule", - "Yiqizishen granule", - "Placebo Bufeijianpi granule", - "Placebo Bufeiyishen granule", - "Placebo Yiqizishen granule" - ], - "diseases": "['Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "564.0", - "inclusion_criteria": "inclusion criteria: \n\n A confirmed diagnosis of severe to very severe COPD. \n\n medically stable \n\n Age between 40 and 80 years. \n\n Syndrome differentiation belongs to syndrome of deficiency of pulmonosplenic qi, syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney. \n\n with a two-week wash-out period prior to randomization \n\n Without participations in other interventional trials in the previous one month. \n\n With the informed consent signed. \n\n ", - "exclusion_criteria": ": \n\n Pregnant or breast-feeding women. \n\n Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study. \n\n Current respiratory disorders other than COPD (e.g., bronchiectasis, bronchial asthma, tuberculosis, lung fibrosis, pulmonary thromboembolic, diffuse panbronchiolitis). \n\n Complicated with a neuromuscular disorder, which affected the respiration. \n\n Complicated with heart failure (NYHA Class III or IV),or myocardial infarction within six months ,or unstable hemodynamics. \n\n Complicated with malignancy, congenital or acquired immune deficiency. \n\n Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation). \n\n Participating in other trials or allergic to the used medicine.", - "brief_summary": "The aim of this study is to compare the effectiveness of two treatments for severe / very severe COPD patients: one, conventional medicine based on 2013 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines; the other, TCM treatments and conventional medicine, which have been evaluated and have certain effect.", - "NCTID": "NCT02270424" - }, - { - "brief_title": "SERETIDE 50/500mcg Versus Tiotropium Bromide On Exacerbation Rates In Severe Chronic Obstructive Pulmonary Disease", - "phase": "Phase 4", - "drugs": "['Tiotropium bromide 18mcg', 'Fluticasone propionate/ salmeterol combination 50/500mcg']", - "drugs_list": [ - "Tiotropium bromide 18mcg", - "Fluticasone propionate/ salmeterol combination 50/500mcg" - ], - "diseases": "['Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "1270.0", - "inclusion_criteria": "inclusion criteria: \n\n Established clinical history of moderate to severe COPD. \n\n Post bronchodilator FEV1 of < 50% of predicted normal. \n\n FEV1 / FVC ratio <70%. \n\n Reversibility to 400mcg albuterol of less or equal to 10 predicted at Visit 1. \n\n Free from exacerbation in the 6 weeks prior to screening. \n\n Current or former smoker with a smoking history of = 10 pack-years and has a history of COPD exacerbations. \n\n ", - "exclusion_criteria": ": \n\n Current asthma, eczema, atopic dermatitis and/or allergic rhinitis. \n\n Has a known respiratory disorder other than COPD (e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis). \n\n Has narrow-angle glaucoma, prostatic hyperplasia or obstruction of the neck of the bladder that in the opinion of the investigator should prevent the subject from entering the study. \n\n Has undergone lung transplantation and/or lung volume reduction. \n\n Female who is a nursing mother. \n\n Requires regular (daily) long-term oxygen therapy (LTOT). \n\n Is receiving beta-blockers (except eye drops). \n\n Has a serious, uncontrolled disease likely to interfere with the study. \n\n Has received any other investigational drugs within the 4 weeks prior to Visit 1. \n\n Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse. \n\n Has a known or suspected hypersensitivity to beta2-agonists, inhaled corticosteroids, anticholinergic agents or any components of the formulations (e.g. lactose or milk protein).", - "brief_summary": "This is a comparator study to assess the relative efficacy of the combination product fluticasone propionate/salmeterol 50/500 and tiotropium bromide on the rate of exacerbations of chronic obstructive pulmonary disease (COPD) over a two year study interval.", - "NCTID": "NCT00361959" - }, - { - "brief_title": "Pennsylvania Study Of Chronic Obstructive Pulmonary Exacerbations", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "1066.0", - "inclusion_criteria": "inclusion criteria: \n\n Phase 1 & Gene Expression: --Current hospitalization for COPD exacerbation \n\n Phase 1 & 2: COPD & ONE of the following criteria: \n\n History of hospitalization for COPD exacerbation, OR \n\n Currently on supplemental oxygen, OR \n\n History of evaluation for lung transplant or LVRS, OR \n\n >/= 6 months post-LVRS \n\n Phase 1 or 2: \n\n Current or former smoker, >/= 20 pack-yr. smoking history \n\n FEV1 6 months \n\n ", - "exclusion_criteria": ": \n\n < 20 pack-yr. smoking history \n\n Diagnosis of pulmonary fibrosis, bronchiectasis, mediastinal mass, or presence of a pulmonary mass \n\n Asthma \n\n FEV1 > 70% or FEV1/FVC >70%", - "brief_summary": "The overall purpose of PA-SCOPE is to determine why black and rural residents of Pennsylvania might be at higher risk for deadly, debilitating, and costly hospitalizations for chronic obstructive pulmonary disease (COPD)- and then to show that repeat acute exacerbations in high-risk patients can be reduced with one simple intervention. We believe that 1) COPD patients who are black or who live in rural areas of Pennsylvania are at higher risk of acute exacerbations requiring hospitalization and 2) this elevated risk can be reduced with one simple intervention: access to a 1-800 Temple Call Center where patients can get immediate customized advice on managing COPD exacerbations in their early stages. We will test these beliefs in PA-SCOPE. The collaborators with Temple University Hospital on the PA-SCOPE project are Lancaster General Hospital, Western Pennsylvania Hospital, and the Philadelphia College of Osteopathic Medicine.", - "NCTID": "NCT00774176" - }, - { - "brief_title": "The Role of Nebulized Budesonide in the Treatment of Acute Exacerbations of COPD", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['COPD Acute Exacerbation']", - "diseases_list": [ - "COPD Acute Exacerbation" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n COPD patients who were admitted to our pulmonary department for an acute exacerbation were prospectively enrolled in the study \n\n ", - "exclusion_criteria": ": \n\n COPD patients hospitalized with specific reasons like pneumonia, pulmonary emboli, congestive heart failure, pneumothorax etc. as the cause of acute exacerbation, or patients with risk of imminent respiratory failure requiring mechanical ventilation or direct admission to the ICU were excluded.", - "brief_summary": "This study was designed to evaluate the hypothesis that nebulized budesonide) might be an alternative to systemic corticosteroids (SC) in the treatment of patients with acute exacerbations of COPD (AECOPD).", - "NCTID": "NCT00274222" - }, - { - "brief_title": "Comparative Effectiveness of Symbicort vs. Advair Among COPD Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['COPD']", - "diseases_list": [ - "COPD" - ], - "enrollment": "3000.0", - "inclusion_criteria": "inclusion criteria: \n\n Continuous health plan enrollment for 12 months before and after index Rx, at least one prescription for BFC or FSC during intake period, naive to ICS/LABA therapies in year prior to first prescription claim, COPD diagnosis, aged 40 or over at time of first prescription. \n\n ", - "exclusion_criteria": ": \n\n ICS/LABA combination during pre-index period, patients with a claim for BFC and FSC on the same day, patients diagnosed with cancer, patients with long-term OCS medication use during pre-index period.", - "brief_summary": "This study is intended to evaluate treatment effectiveness of BFC compared to FSC in COPD patients new to ICS/LABA combination therapy.", - "NCTID": "NCT01921127" - }, - { - "brief_title": "Strategy for Early Treatment of Exacerbations in COPD: Standing Prescriptions of Advair With a Written Action Plan in the Event of an Exacerbation", - "phase": "Phase 4", - "drugs": "['Double dose of Salmeterol + Fluticasone Propionate', 'Self-management education on the use of a self-administered prescription for exacerbation.', 'Self-administered prescription']", - "drugs_list": [ - "Double dose of Salmeterol + Fluticasone Propionate", - "Self-management education on the use of a self-administered prescription for exacerbation.", - "Self-administered prescription" - ], - "diseases": "['COPD', 'Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "COPD", - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "37.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of stable COPD; \n\n 40 years or older; \n\n Smoking history of at least 10 pack-years; \n\n Forced Expiratory Volume in one second (FEV1) \u2264 70 % of predicted value and FEV1 / Forced Vital Capacity (FVC) < 0.70; \n\n Dyspnea \u2265 2 on the Medical Research Council (MRC) scale; \n\n At least 2 exacerbations requiring prednisone treatment in the past 3 years; \n\n Using a written action plan and having demonstrated adequate use of the self-administered antibiotic & prednisone (adequate use defined as prednisone started by the patient within 72 hours of symptom worsening and patient called the case-manager as recommended for following the response); \n\n Already on Advair BID (twice a day) as a maintenance therapy or able to switch over to Advair if already taking another combination medication (Symbicort) as maintenance therapy for COPD. \n\n ", - "exclusion_criteria": ": \n\n History of asthma or allergic rhinitis before the age of 40; \n\n Regular use of oxygen, oral corticosteroids, antibiotics; \n\n Unstable or life threatening co-morbid condition; \n\n Medical conditions or taking medications known to affect tremor and/or heart rate (HR). \n\n Pre-existing medical conditions or on concomitant medications contraindicated with salmeterol or fluticasone propionate (e.g. monoamine oxidase inhibitors and tricyclic antidepressants, beta-adrenergic receptor blocking agents, non potassium-sparing diuretics, inhibitors of cytochrome P450 (ritonavir, ketoconazole)); \n\n On theophyllines. \n\n Colonized with pseudomonas aeruginosa.", - "brief_summary": "The purpose of this pilot study is to determine whether early treatment of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) with a combination therapy, Salmeterol + Fluticasone Propionate (SFP - Advair) will reduce the use of prednisone, known as the conventional treatment.~Primary objective: To determine whether early treatment with combination therapy (SFP) can reduce the use of prednisone (the conventional treatment) in the event of an AECOPD.~Secondary objectives:~To evaluate the feasibility of this treatment approach and to provide pilot data (needed for a larger multi-centre clinical trial;~To evaluate the feasibility and need of assessment during and after exacerbation onset, health-related quality of life and physical activity;~To evaluate the safety of this approach; this is in terms of the delay in starting prednisone and an unfavourable outcome (ER visits and/or hospitalization).", - "NCTID": "NCT02136875" - }, - { - "brief_title": "Responses Induced by Smoking in Individuals Being Susceptible and Non-Susceptible for Development of COPD", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18-75 years \n\n Age, pack years, FEV1/FVC and FEV1% predicted must fit in one of the 5 groups described above. \n\n Able to stop smoking for 10 days and start smoking 3-4 cigarettes within 1 hour \n\n Physically and mentally able to undergo the total study protocol \n\n Written informed consent \n\n ", - "exclusion_criteria": ": \n\n Participation in another study \n\n Alpha-1-antitrypsin deficiency \n\n Selected grade 1-3 co-morbidity listed in the ACE-27 \n\n Active pulmonary infection like tuberculosis, pneumonia, flue, tracheobronchitis \n\n Active extra-pulmonary infection like hepatitis A-C, cystitis, gastro-enteritis etc \n\n Pulmonary diseases like sarcoidosis, IPF, silicosis, hypersensitivity pneumonitis \n\n Life threatening diseases like carcinoma, AIDS (including HIV+), acute leukaemia etc \n\n Medication that may affect the results of the study: NSAID's, immunosuppressive agents like prednisolon, metotrexate, azathioprine,Acenocoumarol", - "brief_summary": "COPD is ranked number 3 by the WHO list of important diseases worldwide and is the only disease with increasing mortality. The pathogenesis of cigarette smoke-induced COPD is obscure, therefore more insight is needed to design effective anti-inflammatory agents. We hypothesize that healthy individuals who are susceptible to smoking demonstrate a higher and aberrant inflammatory response to cigarette smoke. This susceptibility is caused by heterogeneous factors and is associated with various polymorphic genes that interact with each other and with the environment.~Objective:~To define mediators involved in the early induction of COPD in susceptible smokers (and so to define new drug targets)~To develop new biological and clinical markers for the early diagnosis and monitoring of COPD~To compare between susceptible and non-susceptible individuals the corticosteroid responsiveness of bronchial epithelial cells in vitro, and to study the mechanisms of smoking-induced corticosteroid unresponsiveness.~To study the role of candidate genes that may play a role in the development of fixed airway obstruction, and to identify clues for patient's responsiveness to specific drugs.", - "NCTID": "NCT00807469" - }, - { - "brief_title": "Analysis of the Time Taken to Triple Therapy (NOVARTIS)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['COPD']", - "diseases_list": [ - "COPD" - ], - "enrollment": "20154.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged \u226540 years at initial date of COPD diagnosis \n\n COPD diagnosis with Quality Outcome Framework (QoF) approved read code \n\n has spirometry data supportive of a COPD diagnosis in the 5 years around initial date diagnosis of COPD (FEV1 % predicted) \n\n Patient has one year of data prior to initial date of COPD diagnosis \n\n Patient has a minimum of two years of data post initial date of COPD diagnosi \n\n ", - "exclusion_criteria": ": \n\n Patients whose initial date of COPD diagnosis is before 1997", - "brief_summary": "The proposed study will evaluate (for newly diagnosed Chronic Obstructive Pulmonary Disease (COPD) patients)the time taken to prescription of triple therapy by aiming to answer these following research questions:~The percentage of patients prescribed triple therapy, and when they first started receiving triple therapy.~For patients prescribed triple therapy, the time taken to triple therapy from initial diagnosis of COPD.~The variation in treatment pathways.~The factors associated with time taken to triple therapy.", - "NCTID": "NCT01786720" - }, - { - "brief_title": "Evaluation of the Efficacy and Safety of QVA149 (110/50 \u03bcg o.d.) vs Tiotropium (18 \u00b5g o.d.) + Salmeterol/Fluticasone Propionate FDC (50/500 \u00b5g b.i.d.) in Patients With Moderate to Severe COPD", - "phase": "Phase 4", - "drugs": "['QVA149', 'Tiotropium', 'Salmeterol/fluticasone']", - "drugs_list": [ - "QVA149", - "Tiotropium", - "Salmeterol/fluticasone" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease (COPD)']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease (COPD)" - ], - "enrollment": "1053.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who have signed Informed Consent Form prior to initiation of any study-related procedure. \n\n Male and female adults aged \u2265 40 years. \n\n Patients with moderate to severe airflow obstruction with stable COPD (Stage 2 or Stage 3) according to the 2014 GOLD Guidelines. \n\n Patients with a post-bronchodilator FEV1 \u226540 and < 80% of the predicted normal value, and post-bronchodilator FEV1/FVC < 0.70 at run-in Visit 101. (Post refers to 15 min after inhalation of 400 \u00b5g of salbutamol). \n\n Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 years, or \u00bd pack/day x 20 years). An ex-smoker is defined as a patient who has not smoked for \u2265 6 months at screening. \n\n Patients who are on triple treatment at least for the last 6 months (LAMA +LABA/ICS). \n\n ", - "exclusion_criteria": ": \n\n Patients who have not achieved acceptable spirometry results at Visit 101 in accordance with ATS (American Thoracic Society)/ERS (European Respiratory Society) criteria for acceptability (one retest may be performed for patients that don't meet the acceptability criteria) . \n\n Patients who have had more than one COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the last year prior to Visit 1. \n\n Patients who developed a COPD exacerbation of any severity either 6 weeks before the screening (Visit 1) or between screening (Visit 1) and treatment (Visit 201) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation. \n\n Other protocol-defined inclusion/", - "brief_summary": "This study will evaluate the efficacy and safety of QVA149 (110/50 \u03bcg o.d.) vs tiotropium (18 \u00b5g o.d.) + salmeterol/fluticasone propionate FDC (50/500 \u00b5g b.i.d.) in patients with moderate to severe COPD", - "NCTID": "NCT02603393" - }, - { - "brief_title": "Chest Ultrasound of ER Patients With Cough or SOB", - "phase": "", - "drugs": "['Nuvis Diagnostic Ultrasound System']", - "drugs_list": [ - "Nuvis Diagnostic Ultrasound System" - ], - "diseases": "['Cough', 'Dyspnea', 'Wheezing']", - "diseases_list": [ - "Cough", - "Dyspnea", - "Wheezing" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Presenting to the Emergency Department with cough, wheezing and/or dyspnea (shortness of breath) \n\n Referred for CXR and/or CT scan \n\n ", - "exclusion_criteria": ": \n\n Life threatening medical condition requiring immediate treatment \n\n Unable to sit up for a chest ultrasound \n\n Unable to consent \n\n Pregnant \n\n Unable to speak, read and write in English", - "brief_summary": "Acute dyspnea (shortness of breath) is a common complaint for patients presenting to the Emergency Department (ED). The chest radiograph (CXR) has been the mainstay in evaluating patients with shortness of breath and often provides the timely diagnosis of pneumonia, pneumothorax, pulmonary edema, among other primary diseases of the lung. There are limitations with chest radiograph such as large body mass (e.g, obesity) and patient positioning. On occasion, chest radiography findings are difficult to interpret. Lung ultrasonography may offer a means of clarifying ambiguous results.~The objective of this study to determine the usefulness of point of care lung ultrasound in evaluating patients presenting to the ED with shortness of breath, cough and/or wheezing.", - "NCTID": "NCT02269761" - } - ], - "2": [ - { - "brief_title": "Substudy : Patients With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease", - "phase": "", - "drugs": "['No specific intervention for this study']", - "drugs_list": [ - "No specific intervention for this study" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n male and female \n\n COPD with an FEV1 of under 60% of predicted \n\n non-smoker \n\n between 50 and 75 years old \n\n experiencing an acute exacerbation of COPD (24-48 hours, before treatment) \n\n ", - "exclusion_criteria": ": \n\n all inflammatory disease (HIV, cancer, renal and cardiac deficiency) \n\n hormonal dysregulation \n\n inferior limb pathology \n\n neuromuscular pathology \n\n history of tobacco or alcool abuse \n\n oxygen dependent", - "brief_summary": "Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Its prevalence is in progression and COPD is expected to become the fourth leading cause of death by 2030. COPD is characterized by periods of stability interspersed with acute infectious/inflammatory flare-ups, also called acute exacerbations, during which patients deteriorate, sometimes to the point of requiring immediate medical assistance. Although most patients eventually recover, repeated episodes of exacerbations may accelerate COPD progression. Exacerbations may further compromise the integrity of limb muscles by promoting further loss in muscle mass and strength.~The overall objective of this substudy is to elucidate how an acute COPD exacerbation may affect limb muscles.", - "NCTID": "NCT02282436" - }, - { - "brief_title": "Predictive Questionnaires for Risk of Acute COPD (Chronic Obstructive Pulmonary Disease) Exacerbations", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['COPD']", - "diseases_list": [ - "COPD" - ], - "enrollment": "634.0", - "inclusion_criteria": "inclusion criteria: \n\n Signed informed consent \n\n Age \u2265 40 years \n\n Patients fulfilling criteria for COPD according to the Global initiative for chronic obstructive pulmonary disease (GOLD) stage I or higher \n\n Smokers or ex-smokers of at least 10 pack-years \n\n Patients suffering an AECOPD either: \n\n Admitted to hospital due to AECOPD (severe exacerbation) or \n\n Confirmed AECOPD at GP (general practitioner) setting (moderate exacerbation) Definition AECOPD: Increase in respiratory symptoms requiring treatment with oral corticosteroids, antibiotics or both. \n\n ", - "exclusion_criteria": ": \n\n Patients who have never smoked \n\n Patients with active long-term respiratory disease (e.g. bronchial asthma, cystic fibrosis, severe bronchiectasis, malignancy, restrictive lung diseases etc.) \n\n Exacerbation of COPD due to other causes such as pneumothorax and acute decompensated congestive heart failure \n\n Difficulties in communication (cognitive deterioration, sensorial disability, language barriers) \n\n Severe disease with poor vital prognosis (life length expectancy less than one year)", - "brief_summary": "COPD patients frequently suffer intermittent exacerbations of their disease characterised by acute deterioration of symptoms. Acute exacerbations of COPD (AECOPD) are associated with significant impairment of health status, use of health care resources, poor prognosis and increased mortality. The development of simple and practical predictive tools would help to identify COPD patients at greater risk of suffering exacerbations, which is important since those patients would need more intense and early treatment.~This one-year prospective cohort non-drug study will evaluate several COPD-specific questionnaires as predictive tools and the presence of cardiovascular comorbidities as risk factors, for the composite events in study cohorts. The trial duration consists of a screening period (4-6 weeks) and a follow-up period (12 months), 4 visits in total along the study.", - "NCTID": "NCT01248507" - }, - { - "brief_title": "Danish Quality Assurance Project on Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (COPD) in Outpatient Lung Clinics", - "phase": "", - "drugs": "['Education']", - "drugs_list": [ - "Education" - ], - "diseases": "['Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "1820.0", - "inclusion_criteria": "inclusion criteria: \n\n Outpatient with the diagnosis or referral diagnosis of COPD. \n\n COPD must be the primary reason for this outpatient contact (for both new patients and controls). \n\n ", - "exclusion_criteria": ": \n\n Any co-morbidity that hampers the diagnosis and treatment of COPD in accordance with the COPD guidelines used locally (e.g. malignant disease, dementia or sequelae of apoplexy). \n\n Asthma without the presence of COPD", - "brief_summary": "Danish Quality Assurance Project on Diagnosis and Treatment of COPD in Outpatient Lung Clinics", - "NCTID": "NCT00268866" - }, - { - "brief_title": "Endothelial Dysfunction in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Pulmonary Disease (COPD)', 'Inflammatory Disease', 'Endothelial Dysfunction']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease (COPD)", - "Inflammatory Disease", - "Endothelial Dysfunction" - ], - "enrollment": "29.0", - "inclusion_criteria": "inclusion criteria: \n\n presence of COPD according to standard criteria \n\n acute exacerbation of COPD according to recommended international criteria \n\n over 40 years of age \n\n history of at least 10 py \n\n ", - "exclusion_criteria": ": \n\n pneumonia \n\n history or signs of congestive heart failure, \n\n acute myocardial infarction \n\n thoracotomy incl. resection of lungtissue \n\n interstitial lung disease \n\n acute or chronic renal failure \n\n active malignancy \n\n autoimmune disease", - "brief_summary": "The purpose of the study is to determine a possible association between the clinical entity of exacerbation, markers of systemic inflammation and endothelial dysfunction in patients with COPD.", - "NCTID": "NCT01460082" - }, - { - "brief_title": "Treatment in Patients Hospitalized With Acute Exacerbation of Chronic Obstructive Pulmonary Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "400.0", - "inclusion_criteria": "inclusion criteria: \n\n Hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease \n\n Age\u2265 40years old \n\n ", - "exclusion_criteria": ": \n\n The first diagnosis which caused hospitalization is not acute exacerbation of chronic obstructive pulmonary disease \n\n Chest radiography shows congestive heart failure \n\n Chest CT shows lung cancer, active pulmonary tuberculosis, pulmonary thromboembolism or interstitial lung diseases \n\n Serious cardiac failure, renal insufficiency or hepatic dysfunction", - "brief_summary": "Chronic obstructive pulmonary disease has become a serious global health care and public health problems due to its high prevalence, high morbidity and heavy economic burden. Acute exacerbation of chronic obstructive pulmonary disease is one of the most important causes of death in patients with COPD. Systemic corticosteroids therapy is recommended in COPD exacerbations. In clinical practice for the treatment of acute exacerbation of COPD\uff0c antibiotic application is still controversial. Evidence from current guideline is based on strict criteria from randomized controlled trials, thus the given condition is simplified. Patients meet the criteria account for the minority in the real world. Therefore, it is still not clear whether most patients benefit from the recommended treatment. In our design, hospitalized patients with acute exacerbation of COPD will be enrolled, with their treatment, arterial hypoxemia, recovery time and length of hospitalization being observed. The main purpose is to evaluate the benefit effect of current recommended treatment of acute exacerbation of COPD in the real world.", - "NCTID": "NCT02219360" - }, - { - "brief_title": "COPD Research Registry", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Pulmonary Disease (COPD)']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease (COPD)" - ], - "enrollment": "50000.0", - "inclusion_criteria": "inclusion criteria: \n\n -Individuals over the age of 18 who have COPD or may be considered to be at increased risk for development of COPD. \n\n ", - "exclusion_criteria": ": \n\n -Individuals under the age of 18", - "brief_summary": "The COPD Research Registry is a confidential database of individuals diagnosed with COPD or at risk of developing COPD. The Registry was established in 2007 by the COPD Foundation with the purpose of providing a mechanism for researchers to boost enrollment in clinical trials and other research studies. The COPD Foundation is working with National Jewish Health in Denver, Colorado to serve as the Registry's Data Coordinating Center and to ensure strictest confidentiality of participant information.", - "NCTID": "NCT01785706" - }, - { - "brief_title": "Smoking Cessation in Patients With COPD (SMOCC) in General Practice", - "phase": "Phase 4", - "drugs": "['Counseling and Nicotine replacement (CN)', 'Counseling, Nicotine replacement and Bupropion (CNB)']", - "drugs_list": [ - "Counseling and Nicotine replacement (CN)", - "Counseling", - "Nicotine replacement and Bupropion (CNB)" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease (COPD)']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease (COPD)" - ], - "enrollment": "667.0", - "inclusion_criteria": "inclusion criteria: \n\n A software program using Anatomical Therapeutical Chemical (ATC) prescription codes and International Classification of Primary Care (ICPC) diagnosis codes selected potential patients with COPD. Criteria: age >35 years and a diagnosis recorded as COPD or as ICPC code R95/96, or a prescription of at least three times of bronchodilators (ATC code R03a/bc) and/or prescription of at least two times of inhaled anti-inflammatory medication in the past year (ATC code R03). General practitioners (GPs) had to confirm the diagnosis of the selection. Patients were eligible to participate if they met the following criteria: \n\n Current smoking \n\n Suffering from COPD according to the GP's diagnosis \n\n In command of the Dutch language. \n\n ", - "exclusion_criteria": ": \n\n Too ill \n\n Under control of a chest physician \n\n Serious physical or psychological comorbidity", - "brief_summary": "Background: Smoking cessation is the key element in the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). The role of the general practice in assisting these patients with successful quitting smoking was suboptimal. Therefore we evaluated the effectiveness of two smoking cessation programs (counseling and nicotine replacement) for smokers with COPD in routine general practice, one with (CNB) and one without (CN) the combination with bupropion-SR, compared to usual care (UC) and explored the role of COPD symptoms in successful smoking cessation.~Method: RCT with 667 patients with COPD, 68 general practices were randomly allocated. The usual care group (UC) consisted of 148 patients (22 practices), the first intervention group (counseling plus nicotine replacement (CN) of 243 patients (21 practices) and the second intervention group of 276 patients (25 practices. Main outcome measure was (biochemically verified) point prevalence.", - "NCTID": "NCT00628225" - }, - { - "brief_title": "A Study of Safety and Efficacy of Infliximab (Remicade) in Patients With COPD", - "phase": "Phase 3", - "drugs": "['Infliximab']", - "drugs_list": [ - "Infliximab" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease', 'COPD']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease", - "COPD" - ], - "enrollment": "234.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients must have moderate or severe COPD \n\n Patients must have at least one episode of COPD-related symptoms (eg, cough, sputum production, shortness of breath) within 2 months prior to screening ", - "exclusion_criteria": ": \n\n Patients must not have asthma as main component of obstructive airway disease \n\n Patients must not have had a moderate or severe exacerbation of COPD within previous 1 month", - "brief_summary": "The purpose of this study is to evaluate the safety and effectiveness of infliximab (Remicade) in patients with Chronic Obstructive Pulmonary Disease (COPD). Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.", - "NCTID": "NCT00056264" - }, - { - "brief_title": "Beta-Blockers for the Prevention of Acute Exacerbations of Chronic Obstructive Pulmonary Disease", - "phase": "Phase 3", - "drugs": "['Metoprolol succinate', 'Placebo']", - "drugs_list": [ - "Metoprolol succinate", - "Placebo" - ], - "diseases": "['Pulmonary Disease, Chronic Obstructive']", - "diseases_list": [ - "Pulmonary Disease", - "Chronic Obstructive" - ], - "enrollment": "532.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female subjects, \u2265 40 and less than 85 years of age \n\n Clinical diagnosis of at least moderate COPD as defined by the Global Initiative for Obstructive Lung Disease (GOLD) criteria (53): \n\n Post bronchodilator FEV1/FVC < 70% (Forced expiratory volume in 1 second/ forced vital capacity), \n\n Post bronchodilator FEV1 < 80% predicted, with or without chronic symptoms (i.e., cough, sputum production). \n\n Cigarette consumption of 10 pack-years or more. Patients may or may not be active smokers. \n\n To enrich the population for patients who are more likely to have acute exacerbations (54), each subject must meet one or more of the following 4 conditions: \n\n Have a history of receiving a course of systemic corticosteroids and/or antibiotics for respiratory problems in the past year, \n\n Visiting an Emergency Department for a COPD exacerbation within the past year, or \n\n Being hospitalized for a COPD exacerbation within the past year \n\n Be using or be prescribed supplemental oxygen for 12 or more hours per day \n\n Willingness to make return visits and availability by telephone for duration of study. \n\n ", - "exclusion_criteria": ": \n\n A diagnosis of asthma established by each study investigator on the basis of the recent American Thoracic Society/European Respiratory Society and National Institute for Health and Care Excellence guidelines. \n\n The presence of a diagnosis other than COPD that results in the patient being either medically unstable, or having a predicted life expectancy < 2 years. \n\n Women who are at risk of becoming pregnant during the study (pre-menopausal) and who refuse to use acceptable birth control (hormone-based oral or barrier contraceptive) for the duration of the study. \n\n Current tachy or brady arrhythmias requiring treatment \n\n Presence of a pacemaker and/or internal cardioverter/defibrillator \n\n Patients with a history of second or third degree (complete) heart block, or sick sinus syndrome \n\n Baseline EKG revealing left bundle branch block, bifascicular block, ventricular tachyarrhythmia, atrial fibrillation, atrial flutter, supraventricular tachycardia (other than sinus tachycardia and multifocal atrial tachycardia), or heart block (2nd degree or complete) \n\n Resting heart rate less than 65 beats per minute, or sustained resting tachycardia defined as heart rate greater than 120 beats per minute. \n\n Resting systolic blood pressure of less than 100mm Hg. \n\n Subjects with absolute (Class 1) indications for beta-blocker treatment as defined by the combined American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons Guidelines which include myocardial infarction, acute coronary syndrome, percutaneous coronary intervention or coronary artery bypass surgery within the prior 3 years and patients with known congestive heart failure defined as left ventricular ejection fraction <40%.(29, 30) \n\n Critical ischemia related to peripheral arterial disease. \n\n Other diseases that are known to be triggered by beta-blockers or beta-blocker withdrawal including myasthenia gravis, periodic hypokalemic paralysis, pheochromocytoma, and thyrotoxicosis \n\n Patients on other cardiac medications known to cause atrioventricular (AV) node conduction delays such as amiodarone, digoxin, and calcium channel blockers including verapamil and diltiazem as well as patients taking clonidine. \n\n Hospitalization for uncontrolled diabetes mellitus or hypoglycemia within the last 12 months. \n\n Patients with cirrhosis \n\n A clinical diagnosis of bronchiectasis defined as production of > one-half cup of purulent sputum/day. \n\n Patients otherwise meeting the inclusion criteria will not be enrolled until they are a minimum of four weeks from their most recent acute exacerbation (i.e., they will not have received a course of systemic corticosteroids, an increased dose of chronically administered systemic corticosteroids, and/or antibiotics for an acute exacerbation for a minimum of four weeks).", - "brief_summary": "This is a multicenter, prospective, randomized, double-blind, placebo-controlled trial that will enroll 1028 patients with at least moderately severe COPD over a three year period and follow them at regular intervals for one year. The primary endpoint is time to first acute exacerbation. Secondary endpoints include rates and severity of COPD exacerbations, cardiovascular events, all-cause mortality, lung function, dyspnea, quality of life and metoprolol-related side effects.", - "NCTID": "NCT02587351" - }, - { - "brief_title": "A Pragmatic Cluster Trial of a Tailored Intervention to Improve COPD Management", - "phase": "", - "drugs": "['Implementation educational programme']", - "drugs_list": [ - "Implementation educational programme" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease (COPD)']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease (COPD)" - ], - "enrollment": "540.0", - "inclusion_criteria": "inclusion criteria: \n\n patients with diagnosed COPD via the medical records with code J44 \n\n ", - "exclusion_criteria": ": \n\n terminal illness \n\n cognitive impairments", - "brief_summary": "Background: Chronic Obstructive Pulmonary Disease (COPD) remains a major health problem, which is strongly related to smoking. Despite publication of guidelines on the prevention and treatment of COPD, not all COPD patients receive the best available healthcare. Investigators developed a tailored implementation strategy for improving primary care physicians' adherence to COPD management guidelines. The primary aim of the presented trial is to evaluate the effects of this strategy on physician's performance. The secondary aim is to examine the validity of the tailoring of implementation interventions.~Primary Trial Hypothesis: To study if the rate of adherence to the COPD guideline over a 1 year will increase among participants assigned to the intervention group in comparison to those assigned to the control group?~Methods/Design: A two-arm pragmatic cluster randomized trial is planned. A total of 540 patients with diagnosed COPD will be included from 18 general practices in Poland. A tailored implementation program will be offered to general practitioners. Participating physicians in the intervention practices (n=18) will receive training to provide brief anti-smoking counselling. An additional form containing COPD severity scale will be inserted into patient's medical records. The checklist with key information about the disease and its management while consulting a patient with COPD will be provided to practitioners. Investigators will provide practices with training inhaler devices for general practitioners (GPs) to teach patients in correct use of each device and to note this education/training in patient's medical records. The control practices will provide usual care.~Discussion: The results of this trial will be directly applicable to primary care in Poland and add to the growing body of evidence on interventions to improve chronic illness care.", - "NCTID": "NCT01893476" - }, - { - "brief_title": "Non-invasive Assessment of Pulmonary Vascular Resistance in Elderly Patients With Chronic Obstructive Pulmonary Disease", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chronic Obstructive Pulmonary Disease', 'Pulmonary Hypertension', 'Cor Pulmonale']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease", - "Pulmonary Hypertension", - "Cor Pulmonale" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n diagnosis of COPD stage II, III or IV according to the GOLD guidelines \n\n signed the informed consent \n\n ", - "exclusion_criteria": ": \n\n ischemic cardiopathy \n\n severe valvular disease \n\n atrial fibrillation \n\n left bundle branch block", - "brief_summary": "Many studies have evaluated the viability of measuring the pulmonary vascular resistance (PVR) by non-invasive methods in patients with pulmonary hypertension, pulmonary thromboembolism, ischemic cardiopathy and valvular disease. The investigators have not found other studies which evaluate the PVR in elderly patients with COPD. The hypothesis is that in patients with COPD, the severity of obstruction, expressed by GOLD class, is associated with an increase of PVR.", - "NCTID": "NCT01554774" - }, - { - "brief_title": "Dyspnea and Biomarkers in a Prehospital Setting", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Dyspnea', 'Heart Failure', 'Asthma', 'COPD']", - "diseases_list": [ - "Dyspnea", - "Heart Failure", - "Asthma", - "COPD" - ], - "enrollment": "546.0", - "inclusion_criteria": "inclusion criteria: \n\n patient had to present with shortness of breath as the primary complaint (defined as either the sudden onset of dyspnea without history of chronic dyspnea or an increase in the severity of chronic dyspnea) \n\n ", - "exclusion_criteria": ": \n\n age <18 years \n\n history of renal insufficiency, trauma, severe coronary ischemia (unless patient's predominant presentation was dyspnea), and other causes of dyspnea: \n\n pneumonia \n\n pulmonary embolism \n\n carcinoma \n\n pneumothorax \n\n pleural effusion \n\n intoxications (drugs) \n\n anaphylactic reactions \n\n upper airway obstruction \n\n bronchial stenosis \n\n gastroesophageal reflux disorder \n\n according to the history, clinical status, and additional laboratory tests available in pre-hospital setting (D-dimer, troponin, C-reactive protein)", - "brief_summary": "In patients presenting with acute dyspnea in a pre-hospital setting, the early and correct diagnosis may present a significant clinical challenge. Physical examination, chest radiography, electrocardiography, and standard biological tests often fail to accurately differentiate heart failure (HF) from pulmonary causes of dyspnea. Timely differentiation of HF from other causes of dyspnea may permit the early institution of appropriate medical therapy. Brain natriuretic peptide (BNP) and amino-terminal pro-brain natriuretic peptide (NT-proBNP) have been proposed as early markers of HF and demonstrated to be useful for diagnosing and excluding HF in the emergency department. A combination of BNP or NT-proBNP testing and standard clinical assessment has been suggested to be superior to either tool used in isolation. Some previous studies have also suggested that quantitative capnometry (QC) may be useful in differentiating between cardiac and obstructive causes of respiratory distress. Therefore, the investigators hypothesized that a new combination of NT-proBNP testing, standard clinical assessment, and partial pressure of end-tidal CO2 (PetCO2) would optimize evaluation and differentiation of acute dyspnea in a pre-hospital setting.~The aim of this study was to determine the accuracy of combination of QC, NT-proBNP, and clinical assessment in differentiating acute HF from obstructive pulmonary disease (COPD/asthma) as a cause of acute dyspnea in pre-hospital emergency setting.", - "NCTID": "NCT00878475" - }, - { - "brief_title": "Vasoactive Intestinal Peptide in COPD", - "phase": "", - "drugs": "['Vasoactive Intestinal Peptide (VIP)']", - "drugs_list": [ - "Vasoactive Intestinal Peptide (VIP)" - ], - "diseases": "['COPD', 'Pulmonary Hypertension']", - "diseases_list": [ - "COPD", - "Pulmonary Hypertension" - ], - "enrollment": "34.0", - "inclusion_criteria": "inclusion criteria: \n\n Confirmed moderate to severe COPD with or without pulmonary hypertension \n\n Male and female patients. \n\n Aged 18 - 75 years. \n\n Written consent. \n\n Adequate contraception in female patients of childbearing age. \n\n Negative pregnancy test (four-weekly test repetition). \n\n ", - "exclusion_criteria": ": \n\n Lack of consent \n\n Pregnancy (four-weekly tests) \n\n Lactation \n\n Presumed non-cooperativeness \n\n Patients outside the stipulated age range \n\n Myocardial infarction within the last 12 months \n\n Stroke within the last 12 months \n\n Malignant diseases in anamnesis \n\n Legal incapacity \n\n Parallel participation in a clinical trial \n\n Parallel participation in a clinical trial within the last 4 weeks", - "brief_summary": "This study, a new immunomodulatory therapy of COPD with vasoactive intestinal peptide (VIP) was evaluated. Based on preliminary unpublished clinical and experimental results, the course of disease under VIP treatment and the molecular mechanisms involved were assessed.~34 patients with severe COPD were treated either with VIP inhalation in addition to conventional therapy or inhalation of placebo plus conventional therapy for a period of 3 months. The trial was conducted as a double blind, comparative study with two parallel groups.", - "NCTID": "NCT00464932" - }, - { - "brief_title": "Functional Proteomics of Alveolar Macrophages", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['COPD']", - "diseases_list": [ - "COPD" - ], - "enrollment": "72.0", - "inclusion_criteria": "inclusion criteria: \n\n COPD, smoker \n\n COPD, non smoker \n\n ", - "exclusion_criteria": ": \n\n none", - "brief_summary": "The purpose of this study is to obtain young white blood cells (monocytes) from the investigators donated blood for research into how these cells change into large, mature white blood cells (macrophages) and how smoking causes Chronic Obstructive Pulmonary Disease (COPD).", - "NCTID": "NCT00806091" - } - ] - }, - { - "patient_id": "sigir-201520", - "patient": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", - "0": [ - { - "brief_title": "Dementia Early Recognition and Response in Primary Care", - "phase": "Phase 2; Phase 3", - "drugs": "['Educational Dementia training']", - "drugs_list": [ - "Educational Dementia training" - ], - "diseases": "['Dementia']", - "diseases_list": [ - "Dementia" - ], - "enrollment": "125.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with memory or other cognitive impairments suggestive of dementia syndrome \n\n those with a formal diagnosis of dementia, of any type. \n\n ", - "exclusion_criteria": ": \n\n Patients and carers who are already involved in concurrent research \n\n If the key professional feels that an approach to the person with dementia or their carer would be inappropriate, for example the dementia is very severe, or that an approach may increase distress \n\n and any other important reason that the key professional may have for why the person with dementia or their carer should not be contacted.", - "brief_summary": "The purpose of this study is to develop and test an educational intervention for dementia in primary care, combining timely diagnosis, psychosocial support around the period of diagnosis and management concordant with guidelines.", - "NCTID": "NCT00866099" - }, - { - "brief_title": "Physical Exercise for Prevention of Dementia", - "phase": "", - "drugs": "['Intervention group', 'Control group']", - "drugs_list": [ - "Intervention group", - "Control group" - ], - "diseases": "['Memory Disorders', 'Mild Cognitive Impairment', 'Aging']", - "diseases_list": [ - "Memory Disorders", - "Mild Cognitive Impairment", - "Aging" - ], - "enrollment": "1000.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 50 years old \n\n ", - "exclusion_criteria": ": \n\n Medical conditions that compromise survival or limit physical activity \n\n Geriatric Depression Scale-15 score of 6 or higher \n\n Alcohol intake > 4 units/day \n\n Mini- Mental State Examination < 24 \n\n Clinical Dementia Rating score of 1 or more", - "brief_summary": "The principal aim of this study is to verify whether a program of supervised, multimodal physical exercise improves cognitive function and/or reduces the rate of cognitive decline in older adults", - "NCTID": "NCT02236416" - }, - { - "brief_title": "Intervention Programs for Decreasing Caregiver Burden in Caregivers of Patients With Dementia", - "phase": "", - "drugs": "['Behavioral intervention']", - "drugs_list": [ - "Behavioral intervention" - ], - "diseases": "[\"Alzheimer's Disease\", 'Dementia']", - "diseases_list": [ - "Alzheimer's Disease", - "Dementia" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n 30-80years old \n\n Caregivers who spend their own time with dementia patients over 4 hours a day \n\n caregiver distress scores >= 2 \n\n caregivers of patients in Alzheimer's disease dementia ( mild to moderate stage of dementia, Mini-Mental Status Examination:10 \n\n 26) \n\n ", - "exclusion_criteria": ": \n\n illiterate \n\n severe hearing/visual acuity difficulty \n\n cognitive impairment", - "brief_summary": "The purpose of this study is to investigate if behavioral intervention for dementia caregivers will decrease caregiver burden in caregivers of patients with dementia. This multicenter, randomized trial will be conducted with 80 dementia caregivers, who will be randomized into two groups. One group consists of 40 participants who will receive behavioral intervention and 40 who will not receive intervention (waitlist control). The waitlist control group will be also provided the same intervention after the intervention group has completed the intervention. The behavioral intervention consists of 90-min-session a day with an interval of two weeks for 2 months. The primary outcome measures are the changes in scores of Zaret's Burden Inventory and Philadelphia Geriatric Center for Moral Scale (PGCMS).", - "NCTID": "NCT02397980" - }, - { - "brief_title": "Tailored Activity Program-Veterans Affairs", - "phase": "", - "drugs": "['Tailored Activity Program', 'Attention Control']", - "drugs_list": [ - "Tailored Activity Program", - "Attention Control" - ], - "diseases": "['Dementia']", - "diseases_list": [ - "Dementia" - ], - "enrollment": "322.0", - "inclusion_criteria": "inclusion criteria: \n\n inclusion criteria for Veterans with dementia include: \n\n English speaking \n\n diagnosed with dementia as above \n\n able to participate in at least two activities of daily living \n\n ADLs - bathing \n\n dressing \n\n grooming \n\n toileting \n\n transferring from bed to chair \n\n not currently participating in any other dementia-related intervention. \n\n If the Veteran with dementia is on any of four classes of psychotropic medications: \n\n antidepressant \n\n benzodiazepines \n\n antipsychotic \n\n anti-convulsant \n\n an anti-dementia medication (memantine or a cholinesterase inhibitor) \n\n We will require that he/she have been on a stable dose for 60 days prior to enrollment to minimize possible confounding effects of concomitant medications (the typical time frame used in clinical trials). \n\n Caregivers of Veterans must be: \n\n English speaking \n\n self-identify as the primary member of the family caring (hands-on or supervision) for the Veteran and 21 years of age or older (male or female) \n\n living with the Veteran \n\n accessible by telephone to schedule interview, intervention sessions and follow-up interviews \n\n planning to live in area for 8 months (to reduce loss to follow-up) \n\n indicate willingness to learn activity use \n\n report one or more NPS in the Veteran in the past month \n\n not currently participating in any other caregiver-related intervention. \n\n Finally, we will require that caregivers taking a psychotropic medication (antidepressant, benzodiazepines, antipsychotic, or anti-convulsant) at time of telephone screen be on a stable dose of the medication for 60 days prior to enrollment. \n\n ", - "exclusion_criteria": ": \n\n Non English speaking \n\n Non-Veteran \n\n No caregiver \n\n No diagnosis of dementia", - "brief_summary": "The Tailored Activity Program - Veterans Administration is a Phase III efficacy trial designed to reduce behavioral symptoms in Veterans with dementia living with their caregivers in the community. The study uses a randomized two group parallel design with 160 diverse Veterans and caregivers. The experimental group receives a transformative patient-centric intervention designed to reduce the burden of behavioral symptoms in Veterans with dementia. An occupational therapist conducts an assessment to identify a Veteran's preserved capabilities, deficit areas, previous roles, habits, and interests to develop activities tailored to the Veteran. Family caregivers are then trained to incorporate activities into daily care. The attention-control group receives bi-monthly telephone contact where education on topics relevant to dementia is provided to caregivers. Key outcomes include reduced frequency and severity of behavioral symptoms using the 12-item Neuropsychiatric Inventory (primary endpoint), reduced caregiver burden, enhanced skill acquisition, efficacy using activities, and time spent providing care at 4 months; and long-term effects (8 months) on the Veteran's quality of life and frequency and severity of behavioral symptoms, and caregiver use of activities. The programs' impact of Veterans Administration cost is also examined. Study precision will be increased through face-to-face research team trainings with procedural manuals and review of audio-taped interviews and intervention sessions.", - "NCTID": "NCT01357564" - }, - { - "brief_title": "A Longitudinal Multidimensional Population Study on Brain Aging", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Dementia', 'Alzheimer Disease', 'Vascular Dementia']", - "diseases_list": [ - "Dementia", - "Alzheimer Disease", - "Vascular Dementia" - ], - "enrollment": "1321.0", - "inclusion_criteria": "inclusion criteria: \n\n to be resident in Abbiategrasso \n\n to be born between 1935 and 1939 \n\n ", - "exclusion_criteria": ": \n\n to refuse to participate \n\n te be not contactable in any way (mail, telephone) \n\n to be legally resident, but actually living somewhere else", - "brief_summary": "Longitudinal observational study of cognitive functions, physical health and biological parameters in the whole population living in Abbiategrasso born between 1935 and 1939,1773 subjects, followed for six years in order to know the prevalence and the incidence of dementia and risk and protective factors of normal and pathological mental aging.~The peculiarities of this study that must assure the outcome efficacy are:~Selected age: since 70-75 years old people represents a transition age from adulthood to old age, it is of special interest to study the evolution of psychic and physical functions of this population~Whole population not a sample study~Location: the small area involved (Abbiategrasso is a town of 30.000 inhabitants)can contribute to guarantee more homogeneity among the subjects and reduce undesired variability~multidimensional assessment(biological, clinical, social, psychological data collected) After initial screening, the recruited population will be followed up for two more times (every two years )", - "NCTID": "NCT01345110" - }, - { - "brief_title": "Implementation Study of Dementia Guidelines in Primary Care", - "phase": "", - "drugs": "['Dementia Training Program']", - "drugs_list": [ - "Dementia Training Program" - ], - "diseases": "['Dementia']", - "diseases_list": [ - "Dementia" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n GP and practice or district nurse must participate as a duo \n\n ", - "exclusion_criteria": ": \n\n None", - "brief_summary": "The purpose of this study is to determine whether a specially developed Dementia Training Program for duos of general practitioners and primary care nurses is able to increase the number dementia diagnoses in elderly people living in the community and increase the adherence to clinical dementia guidelines", - "NCTID": "NCT00459784" - }, - { - "brief_title": "Home-delivered Intervention for Depressed, Cognitively Impaired Elders", - "phase": "", - "drugs": "['Problem Adaptation Therapy (PATH)', 'Supportive Therapy']", - "drugs_list": [ - "Problem Adaptation Therapy (PATH)", - "Supportive Therapy" - ], - "diseases": "['Depression', 'Dementia', 'Geriatrics']", - "diseases_list": [ - "Depression", - "Dementia", - "Geriatrics" - ], - "enrollment": "134.0", - "inclusion_criteria": "inclusion criteria \n\n Age: >64 (65 years and older). \n\n Diagnosis: Major depression, unipolar as determined by the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID), using Diagnostic and Statistical Manual for Mental Disorders (DSM)IV criteria. \n\n Severity of depression: Montgomery Asberg Depression Rating Scale (MADRS) >=18. \n\n Disability, i.e. impairment in at least 1 Instrumental Activity of Daily Living as measured by Philadelphia Multilevel Assessment Instrument - Instrumental Activities of Daily Living subscale (MAI-IADL). \n\n Evidence of at least mild cognitive impairment but not severe impairment (Dementia Rating Scale (DRS) total score between 90 and 133 inclusive). \n\n Caregiver (family member or professional) able and willing to participate in treatment. \n\n Off antidepressants, cholinesterase inhibitors, or memantine or on a stable dosage for 12 weeks and no medical recommendation for change of these agents in the near future. \n\n Command of English sufficient to participate in therapy and research assessments. \n\n ", - "exclusion_criteria": " \n\n High suicide risk, i.e. intent or plan to attempt suicide in near future. \n\n Axis I psychiatric disorder or substance abuse other than unipolar major depression, non-psychotic depression. \n\n Axis II diagnosis of antisocial personality as determined by the SCID personality disorder section (using DSM-IV criteria). \n\n Moderate to Severe Dementia: We will exclude participants with DRS Total Score corresponding to moderate or more severe dementia (DRS Total <=90). \n\n Acute or severe medical illness (i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry); drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids); or chronic addictive drug use. \n\n Current involvement in psychotherapy. \n\n Aphasia.", - "brief_summary": "Among older adults the combination of depression, cognitive impairment (memory problems), and disability contribute to a worsening of physical and mental health and to poor treatment outcomes. Antidepressants help fewer than 40% of depressed elders with memory problems achieve remission from their depression. Interventions involving talking therapy are underdeveloped and understudied. Therefore, this research study will test the efficacy of Problem Adaptation Therapy (PATH), a new home-delivered psychosocial intervention for elders with major depression, memory problems, and disability. PATH focuses on the subject's ecosystem (the patient, the caregiver, and the home-environment) and targets behavioral problems related to both depression and disability.~PATH is delivered in a subject's home, where cognitively impaired, disabled elders face most of their difficulties. Local Home Delivered Meals programs will refer clients who have symptoms of depression and are interested in research. All participants will have an available caregiver (family, significant other, or professional) and will be randomized to 12 weekly sessions of PATH or Supportive Therapy, the current standard of care for talking therapy. The study will test whether home-delivered PATH is more effective than home-delivered Supportive Therapy in reducing the subjects' depression and disability and in increasing self-efficacy over the 12-week treatment period.", - "NCTID": "NCT01350349" - }, - { - "brief_title": "Goals of Care: A Nursing Home Trial of Decision Support for Advanced Dementia", - "phase": "", - "drugs": "['Goals of care decision support']", - "drugs_list": [ - "Goals of care decision support" - ], - "diseases": "['Dementia']", - "diseases_list": [ - "Dementia" - ], - "enrollment": "302.0", - "inclusion_criteria": "inclusion criteria: \n\n Surrogate for nursing home resident with advanced dementia, paired with resident with advanced dementia \n\n ", - "exclusion_criteria": ": \n\n Non-related legal surrogate without personal knowledge of resident", - "brief_summary": "This cluster randomized controlled trial is to examine whether decision support for goals of care can improve quality of communication and decision-making and improve the quality of palliative care for nursing home residents with advanced dementia.", - "NCTID": "NCT01565642" - }, - { - "brief_title": "Making Memory Better for Seniors With Mild Cognitive Impairment", - "phase": "", - "drugs": "['Cognitive training']", - "drugs_list": [ - "Cognitive training" - ], - "diseases": "['Mild Cognitive Impairment']", - "diseases_list": [ - "Mild Cognitive Impairment" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of Mild Cognitive Impairment \n\n ", - "exclusion_criteria": ": \n\n Clinical diagnosis of dementia \n\n History of neurological conditions known to impair cognition \n\n History of alcohol or drug abuse \n\n History of chronic psychiatric illness \n\n Current symptoms of moderate to severe depression (Geriatric Depression Scale >19) or anxiety (Beck Anxiety Inventory >15)", - "brief_summary": "The purpose of this study is to investigate the feasibility and effectiveness of a cognitive training group in individuals with Mild Cognitive Impairment, using a new paradigm that will optimize ecological validity by (1) focusing on everyday memory problems, (2) supplementing traditional memory training with the teaching of an empirically-supported problem-solving approach, and (3) employing a clinically representative sample of individuals with MCI (e.g., not excluding those with mild affective symptoms).", - "NCTID": "NCT01532739" - }, - { - "brief_title": "Dementia Phenotypes in Primary Care, Hospital, and National Mortality Registries", - "phase": "", - "drugs": "['This is not an intervention study']", - "drugs_list": [ - "This is not an intervention study" - ], - "diseases": "['Dementia']", - "diseases_list": [ - "Dementia" - ], - "enrollment": "51000.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients aged 18 years and over \n\n Registered with a participating general practice during the study period \n\n Minimum one year of records prior to study entry meeting CPRD data quality criteria \n\n Followed on or after 1 January 1997 \n\n ", - "exclusion_criteria": ": \n\n Patients without recorded gender \n\n Less than 1 year of follow-up between study entry and date of administrative censoring", - "brief_summary": "Most patients with dementia in the UK use their local hospitals and general (family) practices throughout their illness. Linked electronic health records from primary care, hospital and death certificates records therefore provide useful information about the diagnosis and prognosis of patients who develop dementia.~In this study we will assess the validity of dementia diagnoses in linked primary care, hospital and death records, by examining the timing of important health transitions in patients with recorded dementia, and we will estimate the lifetime risk of recorded dementia in different age and sex groups", - "NCTID": "NCT02549872" - }, - { - "brief_title": "Evaluating the Effectiveness of a Community Based Intervention for Persons With Dementia and Their Caregivers in a Developing Country", - "phase": "", - "drugs": "['Home based, flexible, stepped care intervention', 'Home based, flexible, stepped care intervention after 6 months. Families will be free to choose any health care they desire during the waiting period.']", - "drugs_list": [ - "Home based", - "flexible", - "stepped care intervention", - "Home based", - "flexible", - "stepped care intervention after 6 months. Families will be free to choose any health care they desire during the waiting period." - ], - "diseases": "['Dementia', 'Behavioral Symptoms', 'Mental Health']", - "diseases_list": [ - "Dementia", - "Behavioral Symptoms", - "Mental Health" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n All probable cases will be examined by a trained clinician (AD) to confirm the diagnosis of dementia according to DSM IV criteria and graded using the Clinical Dementia Rating (CDR) Scale. \n\n CDR mild and moderate dementia. \n\n The principal caregiver, as identified by the family, was enrolled for the trial. The principal caregiver was generally the spouse, although in some instances another family member was the principal caregiver, particularly when the spouse was not in a position to care. \n\n ", - "exclusion_criteria": ": \n\n CDR severe dementia or severe co-morbid physical health conditions.", - "brief_summary": "The aim of this trial was to apply a home based, flexible, stepped-care intervention designed to improve the awareness and knowledge of family caregivers regarding dementia, to maximise their caregiving resources and to improve their caregiving skills. A Randomized Controlled Trial (RCT) will be used to evaluate the same wherein the intervention group will get the services immediately and the control arm would receive the same after a period of 6 months.", - "NCTID": "NCT00479271" - }, - { - "brief_title": "Young Onset Dementia - the Difficult Diagnosis and the Stressful Life for the Whole Family", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Frontotemporal Dementia', 'Alzheimer Disease']", - "diseases_list": [ - "Frontotemporal Dementia", - "Alzheimer Disease" - ], - "enrollment": "250.0", - "inclusion_criteria": "inclusion criteria: \n\n Debut of dementia symptoms before the age of 65 years, but age at time of inclusion may be up to 70 years. \n\n FTD (Neary et al 1998 criteria) \n\n Primary progressive aphasia (Mesulam 2003 criteria) \n\n AD (DSM-IV) \n\n Community living, excl. dementia-specific living facilities manned 24/7 \n\n Family member with regular contact at least x 1/week. \n\n ", - "exclusion_criteria": ": \n\n Lack of informed consent \n\n No close or appropriate family member \n\n Frontal lobe dysfunction due to non-progressive injury, i.e. cerebral infarction \n\n Frontal lobe dysfunction due to motor neuron disease (ALS) \n\n Other dementia specific condition with frontal lobe dysfunction (Huntington, HIV, Down syndrome, alcoholic dementia) \n\n Mental retardation \n\n Current substance abuse, incl. excessive alcohol consumption for the past 12 months", - "brief_summary": "People diagnosed with young onset dementia are today mostly assigned to the same healthcare services as people developing dementia at an older age. They and their families are however in a quite different life situation, which is likely to generate different challenges and specific needs for tailored healthcare services, of importance in maintaining their perceived quality of life.~The investigators of this study wish to assess the factors influencing these families' quality of life, their specific needs and their use of healthcare services by the use a combination of quantitative and qualitative methods. The main aim of this study is to provide better future healthcare services to these families, and to develop a programme for optimal collaboration between specialist healthcare services and the local dementia teams.", - "NCTID": "NCT02055092" - }, - { - "brief_title": "Examining the Relationship Between Hormone Therapy (HT) and Cognitive Function (The WHIMS-ECHO Study)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Dementia']", - "diseases_list": [ - "Dementia" - ], - "enrollment": "2922.0", - "inclusion_criteria": "inclusion criteria: \n\n Participated in the WHIMS study \n\n ", - "exclusion_criteria": " \n\n Non-English speaking \n\n Hearing Impaired", - "brief_summary": "This is a prospective, observational study of the cohort of older post-menopausal participants in the WHI Memory Study, a sub-cohort of participants in the WHI Hormone Trials. Annual cognitive assessments and ascertainment of cognitive impairment enable the continued monitoring of long-term effects of randomization to HT on cognition and identification of predictors of cognitive vulnerability and resilience in older women.", - "NCTID": "NCT00745056" - }, - { - "brief_title": "Problem Adaptation Therapy (PATH) vs. Supportive Therapy in Treating Depressed, Cognitively Impaired Older Adults", - "phase": "", - "drugs": "['PATH', 'ST-CI']", - "drugs_list": [ - "PATH", - "ST-CI" - ], - "diseases": "['Depression']", - "diseases_list": [ - "Depression" - ], - "enrollment": "74.0", - "inclusion_criteria": "inclusion criteria: \n\n Meets Diagnostic and Statistical Manual for Mental Disorders(DSM)IV criteria for unipolar major depression \n\n Severity of depression greater than or equal to 17 on MADRS \n\n Disability as determined by at least 1 impairment in instrumental activities of daily living \n\n Evidence of executive dysfunction or impairment in at least one of the following cognitive domains of Dementia Rating Scale (DRS): attention, construction, conceptualization, and memory ([scaled score less than 7] adjusted for age and race based on Mayo's older participants normative data) \n\n Family member or caregiver able and willing to participate in treatment \n\n Not currently taking antidepressants, cholinesterase inhibitors, or memantine or on a stable dosage for 8 weeks prior to study entry with no medical recommendation for change of these agents in the near future \n\n ", - "exclusion_criteria": ": \n\n High suicide risk \n\n Axis I psychiatric disorder or substance abuse other than unipolar major depression or nonpsychotic depression \n\n Axis II diagnosis of antisocial personality \n\n Moderate to severe dementia: DRS total score corresponding to moderate or more severe impairment (scaled score less than or equal to 5) \n\n Acute or severe medical illness (e.g., delirium; metastatic cancer; decompensated cardiac; liver or kidney failure; major surgery; stroke; myocardial infarction during the 3 months prior to entry) \n\n Currently taking drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids) \n\n Currently receiving psychotherapy \n\n Aphasia \n\n Sensory problems \n\n Inability to speak English", - "brief_summary": "This study will evaluate the efficacy of Problem Adaptation Therapy (PATH) vs. Supportive Therapy for Cognitively Impaired (ST-CI) older adults in reducing depression and disability in treating depressed, cognitively impaired older adults.", - "NCTID": "NCT00368940" - }, - { - "brief_title": "Safe & Easy for Alzheimer's Disease and Related Pathologies", - "phase": "", - "drugs": "[\"Patient's answer with non pharmacological therapeutic\"]", - "drugs_list": [ - "Patient's answer with non pharmacological therapeutic" - ], - "diseases": "['Cognitive Deterioration']", - "diseases_list": [ - "Cognitive Deterioration" - ], - "enrollment": "14.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects with a diagnosis of Alzheimer's disease according to NINCDS-ADRDA (McKhann, Drachman et al. 1984) or typical or atypical Alzheimer's disease (Dubois B. et al. 2007). \n\n Score at Mini Mental Test (MMSE) \u226516. \n\n Subjects residing in nursing homes. \n\n Subjects beneficiaries of a social security scheme. \n\n Signature of free and informed consent. \n\n ", - "exclusion_criteria": ": \n\n Failure to pass the neuropsychological tests because of a sensory or motor deficit. \n\n Sensory deficit (olfactory or visual) preventing the patient made perfectly meet the therapeutic solutions. \n\n Prescription of a new treatment psychotropic (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week before the evaluation; \n\n Persons deprived of liberty (administrative or judicial).", - "brief_summary": "All over the world the increasing prevalence of chronic disorders and its impact on functional decline is challenging the sustainability of health care systems. Older individuals also frequently experience the reversible frailty syndrome, which overlaps with chronic diseases, increasing incidence of disability.~Building a global system aiming to take in charge all causes leading to loss of autonomy is a rather complicated task involving numerous Information and Communication technologies (ICT) solutions which are not always easy to use in everyday life.~The SafEE (Safe Easy Environment) project aim is to improve the safety, autonomy and quality of life of older people at risk.~The SafEE2 project develop non pharmacological therapeutic through diferent ICT (stimulation aromatherapy automatic fragrance ...) .~The goal of this study is to validate the acceptability, sensitivity and efficacy of the systems.", - "NCTID": "NCT02518243" - }, - { - "brief_title": "IGF and Other Neurotrophic Factors in Patients With Dementia", - "phase": "", - "drugs": "['lumbar puncture']", - "drugs_list": [ - "lumbar puncture" - ], - "diseases": "['Dementia']", - "diseases_list": [ - "Dementia" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n dementia, controls(lumbar puncture at our department) \n\n ", - "exclusion_criteria": ": \n\n <18\u00e5r \n\n other CNS disease", - "brief_summary": "The global prevalence of dementia is close to 36 million (2010). Furthermore the number is predicted to double in the next 20 years, primarily due to the demographic ageing. A perspective that will challenge the current healthcare systems and national economies.~Dementia is characterized by progressive deterioration in cognition, function and behavior that is sufficiently severe to compromise social and occupational functioning.~The pathogenesis of dementia remains elusive. Thus, there is a need to increase our understanding of the mechanisms leading to the most common forms of dementia. A better understanding of the disease may enable an earlier diagnosis and importantly, a causal treatment of Alzheimer as opposed to the merely symptomatic options available to day.~An experiment with rats and memory might already have taken the first step towards this. The experiment has demonstrated that administration of IGF-II to rats significantly enhances memory retention and prevents forgetting. Furthermore inhibitory avoidance learning leads to an increase in the hippocampal expression of IGF-II. Finally, yet importantly, injections of recombinant IGF-II into hippocampus after training or memory retrieval significantly enhance memory retention and prevent forgetting.~The spinal fluid and the serum will be analysed at the Medical Research Laboratory. The immunological concentrations of IGF-I and -II are measured by validated in-house analyses. Furthermore, Aarhus University Hospital has a unique technique, whereby it is possible to measure the bioactivity of IGF-I and -II in the cerebrospinal fluid. The concentrations of NGF, BDNF and sCD-163 in spinal fluid and serum will be analysed by already established techniques.~The purpose of this study is therefore to define the concentration and biological activity of IGF-I, IGF-II, BDNF, NGF and sCD-163 in the cerebrospinal fluid and serum in patients with Alzheimer's compared with controls.", - "NCTID": "NCT02271750" - }, - { - "brief_title": "Freezing of Gait: Clinical, Cognitive, and Imaging Features", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Parkinson Disease']", - "diseases_list": [ - "Parkinson Disease" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria for Parkinson disease (PD) subjects with freezing of gait (FOG): \n\n Diagnosis of PD by United Kingdom Brain bank criteria \n\n Hoehn & Yahr stage I-IV \n\n Levodopa treated and responsive \n\n Able to manage 12 hours off dopaminergic medication \n\n Age 18-85 years \n\n Presence of FOG by history and seen by examiner at their clinical office visit or in a video taken at home \n\n Able sign a consent document and willing to participate in all aspects of the study \n\n Able to have an MRI scan (no pacemakers or history of claustrophobia) \n\n ", - "exclusion_criteria": " for Parkinson disease (PD) subjects with freezing of gait (FOG): \n\n Dementia that precludes completing study protocol \n\n Stage V PD - unable to walk independently when off \n\n History of FOG without ever being seen to have it \n\n Atypical parkinsonism: Progressive Supranuclear Palsy (PSP), Multiple System Atrophy (MSA), Corticobasal Degeneration (CBD), Vascular Parkinsonism \n\n Treatment with medications that cause parkinsonism: drug-induced parkinsonism \n\n Any neurological or orthopedic disorders that interfere with gait \n\n Treatment with medications that will interfere with NET-PET (norepinephrine transporter-positron emission tomography) ligand binding \n\n a. Noradrenergic drugs: methylphenidate, atomoxetine, serotonin-norepinephrine reuptake inhibitors (e.g., venlafaxine) \n\n Absence or loss of levodopa response \n\n Any contraindications for MRI scan including pacemaker, deep brain stimulator, bladder stimulator, etc. \n\n inclusion criteria for Parkinson disease (PD) subjects but no freezing of gait (FOG): \n\n Diagnosis of PD by United Kingdom Brain bank criteria \n\n Hoehn & Yahr stage I-IV \n\n Levodopa treated and responsive \n\n Able to manage 12 hours off dopaminergic medication \n\n Age 18-85 years, age, gender and duration matched to the PD with FOG recruits \n\n Absence of FOG by history and by exam, confirmed by caregiver and FOG-Q item 3 score of 0. \n\n Able sign a consent document and willing to participate in all aspects of the study \n\n Able to have an MRI scan (no pacemakers or history of claustrophobia) \n\n ", - "brief_summary": "Freezing of gait (FOG) is among the most disabling motor features of Parkinson disease (PD) and is present in other forms of parkinsonism as well. FOG is a brief (usually lasting <30 seconds) episode of absence or a greatly reduced forward movement of the feet despite intention to walk. It typically occurs when patients initiate gait (so-called start hesitation) and when attempting to turn. It is a leading cause of falls and often results in a wheelchair-dependent state. FOG greatly interferes with activities of daily living, causes social isolation and poor quality of life.~FOG is one of the least understood features of PD. It possibly may develop independent of the other motor features of the disease, and be caused by specific pathological changes in the brain. Previous studies on FOG have shown conflicting information and have not lead to clear understanding of the pathophysiology. One key reason for this is that there appears to be multiple subtypes which have rarely been taken into account.~The purpose of this study is to show that different types of FOG exist and to see if there is a connection to cognitive differences or gait patterns.", - "NCTID": "NCT02387281" - }, - { - "brief_title": "Improving Communication About Serious Illness", - "phase": "", - "drugs": "['Communication Feedback Form for Patients with Serious Illness']", - "drugs_list": [ - "Communication Feedback Form for Patients with Serious Illness" - ], - "diseases": "['Critical Illness', 'Chronic Disease', 'Terminal Care', 'Palliative Care', 'Communication', 'Advance Care Planning', 'Neoplasm Metastasis', 'Lung Neoplasms', 'Pulmonary Disease, Chronic Obstructive', 'Heart Failure', 'End Stage Liver Disease', 'Kidney Failure, Chronic']", - "diseases_list": [ - "Critical Illness", - "Chronic Disease", - "Terminal Care", - "Palliative Care", - "Communication", - "Advance Care Planning", - "Neoplasm Metastasis", - "Lung Neoplasms", - "Pulmonary Disease", - "Chronic Obstructive", - "Heart Failure", - "End Stage Liver Disease", - "Kidney Failure", - "Chronic" - ], - "enrollment": "817.0", - "inclusion_criteria": "inclusion criteria: \n\n Eligible primary clinicians will include all clinicians who provide ongoing primary or specialty care to eligible patient populations. This will include primary care physicians (family medicine and internal medicine), oncologists, pulmonologists, cardiologists, gastroenterologists, nephrologists, neurologists, hepatologists, and geriatricians. Primary clinicians may also include nurse practitioners and physician assistants playing a primary role with eligible patients. A primary role denotes any clinician for whom having a discussion about end-of-life care with eligible patients would be indicated \n\n Eligible interprofessional team members will include nurses, social workers and other clinicians who are part of an enrolled primary clinician's clinic team. \n\n Eligible patients will be those under the care of a participating clinician who are 18 years of age or older, have had 2 or more visits with the primary clinician in the last 18 months, and meet diagnostic criteria. Diagnostic criteria include: 1) metastatic cancer or inoperable lung cancer; 2) chronic obstructive pulmonary disease with FEV1 values <35% predicted or oxygen dependence or restrictive lung disease with a TLC < 50% predicted; 3) New York Heart Association Class III or IV heart failure; 4) Child's Class C cirrhosis or MELD score of >17; 5) dialysis-dependent renal failure and either diabetes or a serum albumin of < 2.5; or, 6) older than 75 years with at least one life-limiting chronic illness or older than 90 years. Additional criteria include: PAH w. 6MWD <250m, restrictive lung disease (IPF, ILD) w/ TLC <50%, and cystic fibrosis with FEV1 < 30%. Eligible patients will also be English-speaking and have no significant dementia or cognitive impairment that would limit his/her ability to complete questionnaires. \n\n Eligible family members will be identified by the patient, with the criterion that the patient would want the family member involved in medical decision-making for the patient if he/she was not able. For the purpose of this study, family member is not confined to legal next-of-kin or immediate family member. Any family member, friend, or caregiver is eligible who is English-speaking and has no dementia or delirium limiting his/her ability to complete questionnaires. \n\n ", - "exclusion_criteria": ": \n\n Reasons for exclusion for all subject groups include: legal or risk management concerns; and physical or mental limitations preventing ability to complete research activities.", - "brief_summary": "The purpose of this study is to improve care delivered to patients with serious illness by enhancing communication among patients, families, and clinicians in the outpatient setting. We are testing a new way to help patients share their preferences for talking about end-of-life care with their clinicians and families. To do this we created a simple, short feedback form. The form is designed to help clinicians understand what patients would like to talk about. The goal of this research study is to show that using a feedback form is possible and can be helpful for patients and their families.", - "NCTID": "NCT01933789" - }, - { - "brief_title": "Randomized Evaluation of Default Access to Palliative Services", - "phase": "", - "drugs": "['Default ordering of palliative consult']", - "drugs_list": [ - "Default ordering of palliative consult" - ], - "diseases": "['COPD', 'ESRD', 'Dementia']", - "diseases_list": [ - "COPD", - "ESRD", - "Dementia" - ], - "enrollment": "34239.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 65 years or older \n\n Current hospitalization of at least 3 calendar days (modified ITT) \n\n Diagnosis of one or more of the following: \n\n End-stage renal disease (ESRD) on dialysis \n\n Chronic obstructive pulmonary disease (COPD) with home oxygen dependence or 2 or more hospitalizations in the past 12 months \n\n Dementia admitted from a long-term care facility or prior placement of a surgical feeding tube or 2 or more additional hospitalizations in the past 12 months \n\n ", - "exclusion_criteria": ": \n\n 1. Patients younger than 65 years old will not receive the intervention", - "brief_summary": "This is a large pragmatic, randomized controlled trial to test the real-world effectiveness of inpatient palliative care consultative services in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients. The investigators hypothesize that improved patient-centered outcomes can be achieved without higher costs by simply changing the default option for inpatient palliative care consultation for eligible patients from an opt-in to an opt-out system. To test this hypothesis the investigators will conduct a clinical trial at 11 hospitals using the same electronic health record within Ascension Health, the largest non-profit health system in the U.S.", - "NCTID": "NCT02505035" - }, - { - "brief_title": "Study of Palliative Care Intervention for Advanced Cancer Patients and Their Caregivers -Educate Nurture Advise Before Life Ends (ENABLE III)", - "phase": "", - "drugs": "['Later entry group', 'Early palliative care intervention']", - "drugs_list": [ - "Later entry group", - "Early palliative care intervention" - ], - "diseases": "['Advanced Cancer']", - "diseases_list": [ - "Advanced Cancer" - ], - "enrollment": "360.0", - "inclusion_criteria": "inclusion criteria FOR PATIENTS: \n\n Able to speak and understand English \n\n Over age 18 \n\n NEW diagnosis, recurrence, or progression of an advanced stage cancer within THIRTY days of the date the patient was informed of the diagnosis by his/her oncology clinician. \n\n Estimated survival of 2 years or less \n\n Diagnosed with an advanced stage cancer such as one of the following: \n\n Lung Cancer: Stage IIIB or IV non-small cell, or extensive stage small cell \n\n Breast Cancer: Stage IV with poor prognostic indicators including but not limited to: a) >2 cytotoxic regimens for MBC; b) diagnosis of MBC less then or equal to 12 months since completion of adjuvant or neoadjuvant treatment; c) triple negative disease (ER/PR - and Her 2-);d) parenchymal brain mets and/or carcinomatous meningitis \n\n Gastrointestinal (GI) Cancers: Unresectable stage III or IV \n\n Genitourinary (GU) Cancers: Stage IV (for prostate cancer inclusion is limited to persons with hormone refractory prostate cancer) \n\n Brain Cancer: Unresectable, Grade IV \n\n Melanoma, Stage IV \n\n Hematologic Malignancies -Leukemia (e.g. acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL) - advanced stage, treatment refractory, poor prognosis cell type or chromosomal abnormalities, older age -Lymphoma- Stage IV or treatment refractory Hodgkin's disease or non-Hodgkin's lymphoma -Multiple Myeloma - elevated \u03b22-microglobulin, albumin <3.5, PCLI >1%, CRP >6\u00b5g/mL, elevated LDH, plasmablastic morphology, abnormal. chromosome 13. \n\n Completion of baseline interview \n\n inclusion criteria FOR PATIENTS FOR BIOMARKER SUB-STUDY: \n\n 1. Only patients with lung, breast, GI, GU cancer are eligible \n\n inclusion criteria FOR CAREGIVERS: \n\n Able to read and understand English \n\n Anyone identified by the patient as a person who knows you well & is involved in your medical care. \n\n PATIENT ", - "exclusion_criteria": ": \n\n Dementia or significant confusion (Impaired cognitive status as indicated by a score of 3 or less on the Callahan six-item cognitive screening tool 18) \n\n Axis I psychiatric diagnosis of severe mental illness (DSM-IV) (e.g. schizophrenia, bipolar disorder, or active substance use disorder) \n\n Patients will not be excluded if they do not identify a caregiver \n\n Prior involvement with palliative care service within the last year \n\n Minimum predicted survival of less than 12 weeks (3 months) \n\n PATIENT BIOMARKER SUBSTUDY ", - "brief_summary": "ENABLE III is a randomized clinical trial that evaluates a phone-based palliative care intervention designed to improve quality of life, mood, and symptom management for patients with an advanced stage cancer and their caregivers.~The primary aims of this clinical trial are to determine whether a palliative care intervention (introduced immediately or 12 weeks after diagnosis) can improve survival, quality of life, mood, symptom intensity and end-of-life care.", - "NCTID": "NCT01245621" - }, - { - "brief_title": "Pharmacokinetics of Eleclazine in Adults With Normal and Impaired Renal Function", - "phase": "Phase 1", - "drugs": "['Eleclazine']", - "drugs_list": [ - "Eleclazine" - ], - "diseases": "['Long QT Syndrome']", - "diseases_list": [ - "Long QT Syndrome" - ], - "enrollment": "55.0", - "inclusion_criteria": "inclusion criteria: \n\n All Individuals: \n\n Be a nonsmoker or consume < 20 cigarettes per day \n\n Have a calculated body mass index (BMI) from 18 to 36 kg/m^2, inclusive, at study screening \n\n Have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator \n\n Screening labs within defined thresholds \n\n Individuals with mild, moderate, or severe renal impairment must also meet the following additional inclusion criteria to be eligible for participation in this study: \n\n Must have diagnosis of chronic (> 6 months), stable renal impairment with no clinically significant changes within 3 months (90 days) prior to study drug administration (Day 1) \n\n Individuals with severe renal impairment, creatinine clearance (CLcr) must be 15-29 mL/min, inclusive (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the screening evaluation. If an individual's score changes during the course of the study, the score at screening will be used for classification. \n\n Individuals with moderate renal impairment, CLcr must be 30-59 mL/min, inclusive (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the screening evaluation. If an individual's score changes during the course of the study, the score at screening will be used for classification. \n\n Individuals with mild renal impairment , CLcr must be 60-89, inclusive mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the screening evaluation. If an individual's score changes during the course of the study, the score at screening will be used for classification. \n\n Individuals with normal renal function must also meet the following additional inclusion criteria to be eligible for participation in this study: \n\n Must, in the opinion of the Investigator, be in good health based upon medical history, physical examination, vital signs, and screening laboratory evaluations \n\n Must have an CLcr of \u2265 90 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the screening evaluation. \n\n ", - "exclusion_criteria": ": \n\n History of meningitis or encephalitis, epilepsy, seizures, migraines, tremors, myoclonic jerks, narcolepsy, obstructive sleep apnea, anxiety, syncope, head injuries or a family history of seizures \n\n Presence or history of cardiovascular disease (including history of myocardial infarction based on ECG and/or clinical history, any history of ventricular tachycardia, congestive heart failure, cardiomyopathy, or left ventricular ejection fraction < 40%), cardiac conduction abnormalities, a family history of Long QT Syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years \n\n Syncope, palpitations, or unexplained dizziness \n\n Implanted defibrillator or pacemaker \n\n Medical history of renal carcinoma or hepatorenal syndrome. \n\n Individuals receiving or anticipating use of hemodialysis, peritoneal dialysis, or any other renal replacement therapy or other medical procedure that serves as a surrogate for renal function during the study. \n\n Individuals with fluctuating or rapidly deteriorating renal function. Assessment of the stability of the individual's renal function will be determined by the investigator. \n\n Renal allograft recipients \n\n Experienced hypertensive crisis, required the addition of \u22651 antihypertensive drug, or required more intensive antihypertensive therapy (eg, addition of a new drug class) in the last 3 months", - "brief_summary": "This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of eleclazine and its metabolite, GS-623134, in participants with normal and impaired renal function. Participants in the healthy control group will be matched to participants with impaired renal function by age (\u00b1 5 years), gender, and body mass index (\u00b1 10%).", - "NCTID": "NCT02441829" - }, - { - "brief_title": "Vitamin D's Effect on Physical Performance in the Elderly", - "phase": "", - "drugs": "['Bio-D-Mulsion Forte\u00ae', 'Placebo']", - "drugs_list": [ - "Bio-D-Mulsion Forte\u00ae", - "Placebo" - ], - "diseases": "['Family Member']", - "diseases_list": [ - "Family Member" - ], - "enrollment": "101.0", - "inclusion_criteria": "inclusion criteria: \n\n Men and women ages 55 years and over \n\n English or Spanish speaking \n\n Interest in participating in a novel nutritional supplement program \n\n Willingness to follow recommendations, including going off of all vitamin-D and calcium containing supplements, multivitamins, or OTC medications (e.g., Tums) 2 weeks before starting the study and during the intervention \n\n Scoring 0-2 errors on the Short Portable Mental Status Questionnaire \n\n ", - "exclusion_criteria": ": \n\n Less than 55 years of age \n\n Currently enrolled in another research trial for vitamin D dietary supplements or other bone disease treatments \n\n Unable to consent to the study \n\n Living in a skilled or intermediate care level nursing facility \n\n Women who are pregnant, during their period, or less than 2 days before or after their period at the time of the assessment \n\n Psychiatric diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, major depression with psychotic features, delirium, and alcohol or substance abuse/dependence \n\n Bleeding disorders \n\n Aphasia or sensory, motor, and/or visual disturbances that could interfere with assessments, including inability to walk 10 feet without a walking aid \n\n Gastrointestinal disorders that could lead to uncertain resorption of the study supplements \n\n Major conditions such as neurologic, cardiovascular, pulmonary, renal, endocrine, thyroid, hepatic, autoimmune, or bone/joint that could interfere with vitamin D metabolism, psychometric tests, or body composition assessment (especially renal and heart failure) \n\n Erratic, accelerated, or mechanically-controlled irregular heart rhythms, atrial fibrillation/flutter, or atrioventricular block or implanted electronic device \n\n Any condition restricting blood flow, such as severe systemic vascular resistance \n\n Acute fever, diarrhea, or edema at the time of the assessment \n\n Dermatological lesions or excessive hair that would be in contact with the placement of the electrodes for the ESC assessment \n\n Hematologic or oncologic disorders treated with chemotherapy in the previous two years \n\n Dysfunctional levels of hemoglobins like carboxyhemoglobin or methemoglobin \n\n Active chemotherapy or radiation treatment for cancer \n\n Recent infusion of dyes into the bloodstream such as methylene blue, indocyanine green, indigo carmine, or fluorescein \n\n Diagnosis of a terminal illness \n\n Persons may not be in the second part of the study while participating in another trial for drugs, supplements, or treatment that affects serum vitamin D level \n\n Persons may not be in the second part of the study if they are unwilling to go off all vitamin D and calcium containing supplements, multivitamins, and over the counter medications 2 weeks prior to starting the study and for the duration of the second part of the study \n\n Persons may not be in this study if they are unwilling to have their blood drawn \n\n Persons may not be in the second part of the study if they are taking steroids, HCTZ, or any other drug known to interfere with vitamin D metabolism or taking diuretics or any other drug that interferes with hydration status \n\n Persons may not be in this study if they are unwilling to refrain from alcohol, caffeine, and stimulants (amphetamines) 12 hours before the examination \n\n Persons may not be in this study if they are unwilling to stop physical activity or sauna use 8 hours before the examination \n\n Persons may not be in this study if they are unwilling to remove fingernail polish or false fingernails during the testing", - "brief_summary": "The purpose of this study is to compare vitamin D deficient and vitamin D sufficient elderly individuals and examine the effect of a vitamin D dietary supplement on serum vitamin D level, bone formation, resorption, and mineral density, flexibility, balance, general inflammation,and quality of life. Enhancing nutritional status is necessary to prevent the continued proliferation of chronic diseases, e.g., bone disease and other chronic disorders thought to now be related to low levels of vitamin D, which are some of the leading disablers and killers of Americans. Americans also have difficulties with compliance to prescription medications due to their toxicity and side effects. This study aims to learn more about how a vitamin D nutritional supplement may improve nutritional status and enable the body to normalize system functioning,which may improve the quality of life for people with vitamin D deficiency. The results of this research will be used to determine if vitamin D is beneficial for overall health among elderly individuals.", - "NCTID": "NCT02066441" - }, - { - "brief_title": "Psychosocial Support for Cancer Patients", - "phase": "", - "drugs": "['Dignity Psychotherapy', 'Supportive Psychotherapy', 'Standard Palliative Care']", - "drugs_list": [ - "Dignity Psychotherapy", - "Supportive Psychotherapy", - "Standard Palliative Care" - ], - "diseases": "['Cancer']", - "diseases_list": [ - "Cancer" - ], - "enrollment": "281.0", - "inclusion_criteria": "inclusion criteria: \n\n The patient must be at least 18 years of age (because of the nature of Dignity Psychotherapy, which presumes a relatively advanced level of social and psychological development). \n\n Have a terminal illness (Stage IV with a prognosis of less than 6 months, but expected to live at least 7 to 10 days, i.e. the average length of the protocol) \n\n Must be able to identify a family member/significant other who agrees to participate in the study (in the case of Dignity Psychotherapy, this family member/significant other will receive the generativity document) \n\n Be able to communicate with an English-speaking therapist (patients who are visually impaired will be offered assistance with the consent forms and surveys) \n\n In the investigator's judgement, participant is cognitively able to provide valid, informed consent. \n\n ", - "exclusion_criteria": ": \n\n Significant psychiatric disturbance sufficient to preclude participation in a psychotherapeutic intervention (e.g. acute, severe psychiatric symptoms which would require individual treatment and medication management rather than a psychotherapy intervention). \n\n Active psychotic mental disorder (e.g. schizophrenia, acute mania), or marked paranoid ideation. Patients who are on stable regimens of psychotropic medications (e.g. antidepressants for clinical depression) or who are in concurrent individual or group psychotherapy will not be excluded. This information regarding concurrent psychiatric treatment will be collected and utilized as a co-variate in data analysis. \n\n Presence of a cognitive disturbance (i.e. delirium or dementia) sufficient to preclude participation in psychotherapy, and/or data collection. \n\n Physical limitations or illness severity sufficient to preclude participation in psychotherapy", - "brief_summary": "This is an international, 3-site trial (Winnipeg Canada, MSKCC NYC, Perth Australia) accruing 120 patients per site (120x3). The purpose of this study is to compare two types of counseling for cancer patients: Dignity Psychotherapy and Supportive Psychotherapy as well as Standard Palliative Care. Many cancer patients seek counseling to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. We, the investigators at Memorial Sloan-Kettering Cancer Center, have developed a type of counseling we call Dignity Psychotherapy. It is intended to help cancer patients maintain or enhance a sense of purpose, meaning, and overall quality of life, despite having cancer. Supportive Psychotherapy is another type of counseling intended to help patients feel more at ease and express and reflect on any feelings or concerns they might have about their illness. Both of these types of counseling will be compared to Standard Palliative Care. We will look at how these types of treatments affect patients' mood, outlook, and quality of life. We also want to see how the type of treatment they receive affects their family members and significant others.", - "NCTID": "NCT00133965" - }, - { - "brief_title": "Intervention and Outcomes in Duarte Galactosemia", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Duarte Galactosemia']", - "diseases_list": [ - "Duarte Galactosemia" - ], - "enrollment": "566.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy Children/Children with Duarte Galactosemia: \n\n Age between 6-12 years \n\n ", - "exclusion_criteria": ": \n\n Chronic illness \n\n Any condition unrelated to Duarte Galactosemia but known to cause developmental problems \n\n Children who did not have the current parent/guardian as the primary caregiver when the child was an infant", - "brief_summary": "The purpose of this study is to learn about Duarte galactosemia (DG). This study will examine the possible effects of Duarte galactosemia (DG) in children, and determine whether dietary exposure to milk in infancy or early childhood is associated with developmental outcomes of school-age children with Duarte galactosemia (DG).", - "NCTID": "NCT02519504" - } - ], - "1": [ - { - "brief_title": "A Pilot Study to Explore the Safety and Tolerability of Galantamine HBr in the Treatment of Pick Complex/Frontotemporal Dementia", - "phase": "Phase 2", - "drugs": "['galantamine hydrobromide']", - "drugs_list": [ - "galantamine hydrobromide" - ], - "diseases": "['Frontotemporal Dementia', 'Pick Complex']", - "diseases_list": [ - "Frontotemporal Dementia", - "Pick Complex" - ], - "enrollment": "41.0", - "inclusion_criteria": "inclusion criteria: \n\n Outpatients with a clinical diagnosis of Frontotemporal Dementia or Pick Complex (PC/FTD) documented for at least 1 year with either primary progressive aphasia or frontotemporal dementia \n\n recent MRI or CT confirming frontotemporal lobar atrophy consistent with Frontotemporal Dementia or Pick Complex PC/FTD \n\n opportunity to perform certain activities of daily living as described in the Alzheimer's Disease Cooperative Study -- Activities of Daily Living Inventory \n\n living with or having regular visits (least 4 days/week) from a responsible caregiver \n\n Mini Mental State Examination score > 5 and the ability to complete baseline neuropsychometric testing \n\n able to see, hear, and communicate sufficiently, and willing to complete serial neuropsychometric tests \n\n female subjects of childbearing age must be surgically sterile or practicing an effective method of birth control before entry and throughout the study. \n\n ", - "exclusion_criteria": ": \n\n No neurodegenerative disorders and other causes of dementia or cognitive impairment from acute cerebral injuries, cerebrovascular disease or hypoxic cerebral damage, vitamin deficiency states, infection cerebral neoplasia \n\n no primary memory disturbance or an amnestic syndrome more compatible with Alzheimer's disease or other primary degenerative dementia \n\n no uncontrolled epilepsy or clinically significant psychiatric disease, cardiovascular disease, hepatic, renal, pulmonary, metabolic, or endocrine disturbances, active peptic ulcer and urinary outflow obstruction \n\n no use of any agent used for the treatment of dementia or other cognitive impairment \n\n no history of severe drug allergy or hypersensitivity to cholinesterase inhibitors, choline agonists or similar agents, or bromide", - "brief_summary": "The purpose of this study is to explore the safety and tolerability and the efficacy of galantamine treatment in subjects with Pick Complex/ Frontotemporal Dementia (PC/FTD). The safety and tolerability of galantamine therapy will be assessed over the entire treatment period (26 weeks). The 8 week withdrawal period will be used to confirm the safety of galantamine withdrawal in this subject group and it impact on any symptom improvement achieved during the first 18 weeks of galantamine treatment ( symptom improvement would be expected to stabilize or decline on withdrawal of an effective therapy).~The primary efficacy objective is to explore the effect of galantamine on behavior as measured by the Frontal Behavioral Inventory during the randomized withdrawal period. In addition, for subjects with primary progressive aphasia (limited ability for languages), the effects of galantamine on language will be explored using the Aphasia Quotient of the Western Aphasia Battery, and for all subjects the Clinical Global Impressions will be used to explore global change.", - "NCTID": "NCT00416169" - }, - { - "brief_title": "Improving Decision Making About Feeding Options for Dementia", - "phase": "", - "drugs": "['Feeding Options in Dementia Decision Aid']", - "drugs_list": [ - "Feeding Options in Dementia Decision Aid" - ], - "diseases": "['Dementia']", - "diseases_list": [ - "Dementia" - ], - "enrollment": "256.0", - "inclusion_criteria": "inclusion criteria: \n\n dementia diagnosis \n\n advanced cognitive impairment \n\n feeding problem \n\n age >= 65 \n\n surrogate decision maker \n\n ", - "exclusion_criteria": ": \n\n feeding tube decision made \n\n hospice \n\n BMI > 26 \n\n major psychosis or developmental delay", - "brief_summary": "This study is a randomized trial to test whether a decision aid can help to improve the quality of decision making about feeding options in care of patients with dementia.", - "NCTID": "NCT01113749" - }, - { - "brief_title": "Blood Gene Expression Signature in Patients Diagnosed With Probable Alzheimer's Disease Compared to Patients Suffering From Other Types of Dementia", - "phase": "", - "drugs": "['Blood sampling']", - "drugs_list": [ - "Blood sampling" - ], - "diseases": "[\"Alzheimer's Disease\", 'Dementia']", - "diseases_list": [ - "Alzheimer's Disease", - "Dementia" - ], - "enrollment": "550.0", - "inclusion_criteria": "inclusion criteria: \n\n AD group : \n\n Male or female patient, aged \u2265 40 years old included at entry. \n\n Patients having a clinical diagnosis of probable AD according to DSM-IV TR [F00.xx] and National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria. \n\n Written informed consent obtained from the patient or, if appropriate, from legal representative according to local laws and regulations. \n\n Evidence that brain imaging (either cerebral CT-scan or cerebral MRI) was performed to settle the AD diagnosis, and that the results are compatible with AD diagnosis. \n\n Neurological exam without any particularities or without any specific focal signs likely to be related to other conditions than AD. \n\n Patient compliant with study procedures. \n\n Non AD demented group : \n\n Male or female patient, aged \u2265 40 years old included at entry. \n\n Patients having a clinical diagnosis of dementia which can be one of the following : \n\n VaD according to NINDS-AIREN criteria or, \n\n LBD according to McKeith's criteria, or, \n\n FTD according to Neary's or Lund & Manchester criteria or, \n\n PDD according to DSM-IV TR criteria [F02.x] or, \n\n Mixed dementia which is defined in this study as patients fulfilling DSM-IV TR criteria [F02.8] for dementia with multiple aetiologies focussing on dementia of Alzheimer type with secondary occurrence of vascular dementia. \n\n Written informed consent obtained from the patient or, if appropriate, from legal representative according to local laws and regulations. \n\n Evidence that brain imaging (either cerebral CT-scan or cerebral MRI) was performed to settle the diagnosis of dementia, and that the results are compatible with the diagnosis of dementia. \n\n Absence of other signs or symptoms that may be better related to another type of dementia than the current dementia diagnosis. \n\n Patient compliant with study procedures. \n\n Cognitive impairment-free control group : \n\n Male or female subject, aged \u2265 60 years old included at entry. \n\n Written informed consent obtained from the subject. \n\n Absence of spontaneously reported significant cognitive complaints from the subject at entry. \n\n MMSE \u2265 27 at entry. \n\n Subject with no impairment in daily living activities. \n\n Subject compliant with study procedures. \n\n ", - "exclusion_criteria": ": \n\n AD group : \n\n Any pathology, medical condition or symptoms that may lead to reconsider the initial diagnosis of probable AD, or that may rend the initial diagnosis of probable AD doubtful at entry, according to the opinion of the investigator. \n\n Current or recent history of drug or alcohol abuse or dependence. \n\n Diagnostic of Mild Cognitive Impairment defined by subjective complaints from the patient regarding memory and/or cognitive symptoms, objective memory and/or cognitive impairment at testing but not meeting AD diagnostic criteria, and not affecting daily living activities. \n\n Current diagnosis of brain tumour. \n\n Any current pathology or medical condition, for which blood sampling may involve a risk for the patient's health, according to the opinion of the investigator. \n\n Pregnancy. \n\n Patient who is not registered at S\u00e9curit\u00e9 Sociale. \n\n Current participation in another study using an investigational non-marketed product. \n\n Non-AD demented group : \n\n Any pathology, medical condition or symptoms that may lead to reconsider the initial diagnosis of dementia the patient is suffering from, or that may rend the initial diagnosis of dementia doubtful at entry, according to the opinion of the investigator. \n\n Diagnostic of Mild Cognitive Impairment defined by subjective complaints from the patient regarding memory and/or cognitive symptoms, objective memory and/or cognitive impairment at testing but not meeting the diagnostic criteria for dementia, and not affecting daily living activities. \n\n Current diagnosis of brain tumour. \n\n Any current pathology or medical condition for which blood sampling may involve a risk for the patient's health, according to the opinion of the investigator. \n\n Current or recent history of drug or alcohol abuse or dependence. \n\n Pregnancy. \n\n Patient who is not registered at S\u00e9curit\u00e9 Sociale. \n\n Current participation in another study using an investigational non-marketed product. \n\n Cognitive impairment-free control group : \n\n Subject spontaneously complaining from significant cognitive impairment. \n\n Known family history of dementia. \n\n Diagnosis of any type of dementia (either AD or non-AD dementia), Mild Cognitive Impairment, or any current or past history of CNS pathology (including but not limited to brain injury, brain tumour, stroke, normal pressure hydrocephalus, Parkinson's disease, epilepsy, multiple sclerosis,\u2026) that may be responsible for the occurrence of dementia. \n\n History or current clinically significant psychiatric pathology (including but not limited to psychotic disorders, bipolar disorder, personality disorders). \n\n Current major depressive disorder, either treated or not, associated with clinically significant symptoms. \n\n Any current pathology or medical condition for which blood sampling may involve a risk for the subject's health, according to the opinion of the investigator. \n\n Current or recent history (within one month) of clinically significant pathology, medical condition (including hospitalization) or symptoms. However, chronic diseases or medical conditions which are considered stable are accepted, provided that they are compatible with other study selection criteria. \n\n Current or recent history of drug or alcohol abuse or dependence. \n\n Subject who is not registered at S\u00e9curit\u00e9 Sociale. \n\n Current participation in another study using an investigational non-marketed product.", - "brief_summary": "The objective of the study is to define the performance of blood-based signatures for Alzheimer's Disease (AD) in different patients populations including AD, non-AD dementia, and non-demented controls.", - "NCTID": "NCT00880347" - }, - { - "brief_title": "Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease", - "phase": "Phase 3", - "drugs": "['Standard intervention protocol', 'Standard intervention protocol + Cognitive training therapy', 'Standard intervention protocol + Reminiscence therapy', 'Standard intervention protocol + Made-to-measure program']", - "drugs_list": [ - "Standard intervention protocol", - "Standard intervention protocol + Cognitive training therapy", - "Standard intervention protocol + Reminiscence therapy", - "Standard intervention protocol + Made-to-measure program" - ], - "diseases": "[\"Alzheimer's Disease\"]", - "diseases_list": [ - "Alzheimer's Disease" - ], - "enrollment": "640.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients in the mild to moderate stages of Alzheimer's Disease : MMSE score between 16 and 26 ; and stages 3 to 5 of the Global Deterioration Scale \n\n Patients over 50 years of age \n\n Patients with social security affiliation \n\n ", - "exclusion_criteria": ": \n\n Patients suffering other type of dementia \n\n Institutionalized patients \n\n Patients with psychiatric disorder \n\n Patients with severe pathology in the terminal stages \n\n Patients receiving non pharmacological therapies other than that proposed in the study \n\n Enrollment in a pharmacological trial in the first 6 months", - "brief_summary": "ETNA3 is a multicentric randomised clinical trial conducted in France to evaluate the impact of cognitive training, reminiscence therapy and a made-to-measure program on the progression rate of dementia.", - "NCTID": "NCT00646269" - }, - { - "brief_title": "Effectiveness of Home-based Electronic Cognitive Therapy in Alzheimer's Disease", - "phase": "", - "drugs": "['Intervention Group', 'Control Group']", - "drugs_list": [ - "Intervention Group", - "Control Group" - ], - "diseases": "['Memory Disorders', 'Mild Cognitive Impairment', \"Alzheimer's Disease\"]", - "diseases_list": [ - "Memory Disorders", - "Mild Cognitive Impairment", - "Alzheimer's Disease" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n A diagnosis of mild cognitive impairment due to Alzheimer's disease (MCI due to AD) by the patient's referring clinician per recent National Institutes of Aging-Alzheimer's Association criteria (Albert et al., 2011). \n\n A diagnosis of mild Alzheimer's disease by the patient's referring clinician per recent National Institutes of Aging-Alzheimer's Association criteria (McKhann et al., 2011). \n\n 50-90 years of age. \n\n ", - "exclusion_criteria": ": \n\n Younger than the age of 50 or older than the age of 90. \n\n Any self-reported history of substance abuse or alcohol abuse. \n\n Any self-reported history of prior head trauma (e.g., stroke, traumatic brain injury) \n\n Any prior self-reported history of significant depression or other mood disorder.", - "brief_summary": "The current study will examine the use of a mobile electronic application used to deliver cognitive rehabilitation to patients with mild cognitive impairment due (MCI) due to Alzheimer's disease (AD), and patients with mild AD. Patients will be given a specific cognitive rehabilitation program on their mobile device (iPad) with specific tasks for them to complete. The goal of this study is to determine if a) patients are able to use and adhere to a cognitive rehabilitation program delivered to their mobile device and b) to determine if patients can improve their language, attention, and memory by completing cognitive rehabilitation tasks assigned to them.", - "NCTID": "NCT02521558" - }, - { - "brief_title": "Computerized Personal Interventions for Alzheimer's Patients", - "phase": "", - "drugs": "['Reminiscence therapy', 'Cognitive training', 'No treatment']", - "drugs_list": [ - "Reminiscence therapy", - "Cognitive training", - "No treatment" - ], - "diseases": "[\"Alzheimer's Disease\"]", - "diseases_list": [ - "Alzheimer's Disease" - ], - "enrollment": "159.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of Alzheimer's Disease \n\n MMSE score of 14-26 \n\n ", - "exclusion_criteria": ": \n\n Visual impairment \n\n Auditory impairment \n\n Psychiatric disorders", - "brief_summary": "The purpose of this study is to determine whether the use of computerized systems in 2 common non pharmacological therapies (cognitive training and reminiscence therapy) will improve the cognitive function of patients with mild to moderate Alzheimer's disease (AD), or at least delay its deterioration. In addition, the investigators hypothesize that using the computerized systems will result in improved well-being of the patients and their main caregivers / family members, and in improved patient-caregiver and patient-family relations.", - "NCTID": "NCT01329484" - }, - { - "brief_title": "CJD (Creutzfeldt-Jakob Disease) Quinacrine Study", - "phase": "Phase 2", - "drugs": "['Quinacrine', 'Placebo']", - "drugs_list": [ - "Quinacrine", - "Placebo" - ], - "diseases": "['Creutzfeldt-Jakob Disease']", - "diseases_list": [ - "Creutzfeldt-Jakob Disease" - ], - "enrollment": "69.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of probable or definite sCJD: Definite--biopsy confirmed sCJD; Probable--a progressive dementia with either a typical EEG or a typical MRI consistent with sCJD, and at least two of the following clinical features: myoclonus, pyramidal or extrapyramidal signs, visual symptoms, cerebellar signs, akinetic mutism, other focal higher cortical neurologic signs (e.g. neglect, apraxia, aphasia) \n\n 18 years of age or older \n\n Able to swallow \n\n Able to follow simple one-step commands \n\n Have had a brain MRI within 6 months and an EEG within 3 months ruling out other etiologies such as masses, strokes, or non-convulsive status epilepticus \n\n Consent to autopsy in the event of their death during or after the study \n\n ", - "exclusion_criteria": ": \n\n History of other significant or life-threatening disease, including: cancer; end-stage liver or renal disease; severe heart disease \n\n History of other disease requiring regular supportive care \n\n Liver disease \n\n Active alcoholism \n\n Bone marrow suppression \n\n Severe hypotension \n\n Severe psoriasis \n\n Poorly controlled diabetes \n\n Women who are pregnant or breast-feeding \n\n Men, or women of childbearing age, not practicing reliable contraception \n\n Serious allergies to quinacrine or other acridines \n\n Current or recent use of quinacrine (within 6 months) \n\n < 18 years of age \n\n Any other contraindication to taking quinacrine \n\n Genetic form of prion disease is identified prior to study enrollment \n\n Current use of anti-arrhythmics (at discretion of investigator) \n\n G6PD (Glucose 6-Phosphate Dehydrogenase) deficiency (at discretion of investigator)", - "brief_summary": "The purpose of this clinical trial is to determine the effectiveness of the medication quinacrine on survival in sporadic Creutzfeldt-Jakob disease (sCJD).", - "NCTID": "NCT00183092" - }, - { - "brief_title": "A Long-Term Safety And Tolerability Study Of Bapineuzumab In Alzheimer Disease Patients", - "phase": "Phase 3", - "drugs": "['Bapineuzumab 0.5 mg/kg', 'Bapineuzumab 1.0 m/kg']", - "drugs_list": [ - "Bapineuzumab 0.5 mg/kg", - "Bapineuzumab 1.0 m/kg" - ], - "diseases": "['Alzheimer Disease']", - "diseases_list": [ - "Alzheimer Disease" - ], - "enrollment": "198.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject has completed study 3133K1-3000 and brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of Alzheimer Disease \n\n Mini-Mental Status Examination (MMSE) >=10 at screening \n\n Caregiver able to attend all clinic visits with subject \n\n ", - "exclusion_criteria": ": \n\n Any medical or psychiatric contraindication or clinically significant abnormality that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response. \n\n Any significant brain MRI abnormality. \n\n Use of any investigational drugs or devices, other than bapineuzumab within the last 60 days prior to screening", - "brief_summary": "The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab in subjects with Alzheimer Disease who participated in study 3133K1-3000 (NCT00667810). Over 250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each subject's participation will last approximately 4 years.", - "NCTID": "NCT00996918" - }, - { - "brief_title": "Long Term Extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease", - "phase": "Phase 2", - "drugs": "['ACC-001', 'ACC-001', 'ACC-001']", - "drugs_list": [ - "ACC-001", - "ACC-001", - "ACC-001" - ], - "diseases": "[\"Alzheimer's Disease\"]", - "diseases_list": [ - "Alzheimer's Disease" - ], - "enrollment": "53.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA (NCT00959192) and met all inclusion criteria and non of the ", - "exclusion_criteria": ". \n\n Screening brain MRI scan is consistent with the diagnosis of AD. \n\n MMSE score 10 and above. \n\n ", - "brief_summary": "The purpose of this long term extension study is to assess safety, tolerability and immunogenicity of ACC-001 with QS-21 adjuvant in Japanese subjects with mild to moderate AD who were randomized in the preceding P2 double blind studies.", - "NCTID": "NCT01238991" - }, - { - "brief_title": "Study Evaluating Single Ascending Doses of AAB-001 Vaccine SAD Japanese Patients With Alzheimers Disease", - "phase": "Phase 1", - "drugs": "['bapineuzumab', 'bapineuzumab', 'bapineuzumab']", - "drugs_list": [ - "bapineuzumab", - "bapineuzumab", - "bapineuzumab" - ], - "diseases": "['Alzheimer Disease']", - "diseases_list": [ - "Alzheimer Disease" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of AD \n\n Age 50-85 \n\n MMSE 14-26 \n\n Other inclusion criteria Apply \n\n ", - "exclusion_criteria": ": \n\n Significant Neurological Disease \n\n Major Psychiatric Disorder \n\n Clinically Significant Systemic Illness \n\n Other ", - "brief_summary": "Evaluate safety, tolerability, and pharmacokinetics of single doses of the investigational AAB-001 Vaccine in Japanese patients with Alzheimer's disease.", - "NCTID": "NCT00397891" - } - ], - "2": [ - { - "brief_title": "Effects of Visual Arts Training on Dementia", - "phase": "", - "drugs": "['Visual Arts Training', 'Music Training']", - "drugs_list": [ - "Visual Arts Training", - "Music Training" - ], - "diseases": "['Dementia', 'Alzheimer Disease']", - "diseases_list": [ - "Dementia", - "Alzheimer Disease" - ], - "enrollment": "23.0", - "inclusion_criteria": "inclusion criteria: \n\n dementia \n\n ", - "exclusion_criteria": ": \n\n known comorbid cognitive or neurological impairments", - "brief_summary": "The study will use a randomized controlled trial to test the efficacy of two interventions (visual arts and music) for individuals with dementia, focusing on dementia of the Alzheimer's type (DAT). Interventions will be run for 10 weeks in dementia day centers and/or retirement residences. Participants will be tested before and after the intervention on a battery of cognitive, affective, and behavioural measures. They will be compared to a waitlist control group who don't receive the intervention.~The purpose of our research is twofold: treatment of symptoms and improved quality of life during disease progression in dementia. For the primary aim, the investigators are examining the potential of arts interventions on declining functions in dementia (memory, mood, and behavior) to investigate potential treatment effects. Secondly, quality of life will be measured, with the aim of looking beyond disease progression to contribute to an overall positive patient experience. Research has indicated the need for non-pharmacological treatments to be used as a first line of action against dementia symptoms and development. While, in best practice, pharmacological treatments should be used as a second-line approach.~Note: Music intervention dropped prior to study initiation.", - "NCTID": "NCT02432222" - }, - { - "brief_title": "Study on the Efficacy of Speed-Feedback Therapy for Elderly People With Dementia", - "phase": "Phase 4", - "drugs": "['Speed-feedback therapy system with a bicycle ergometer', 'Ergometer at conventional settings']", - "drugs_list": [ - "Speed-feedback therapy system with a bicycle ergometer", - "Ergometer at conventional settings" - ], - "diseases": "['Dementia']", - "diseases_list": [ - "Dementia" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n 65 years of age or older \n\n Diagnosed with dementia by a physician \n\n Mini-Mental State Examination score of 23 points or less \n\n Capable of participating at least once a week for 6 weeks in succession \n\n ", - "exclusion_criteria": ": \n\n Management of a medical risk required \n\n Impaired ability to pedal the ergometer because of an orthopedic or surgical disease of the lower extremities or central nerve paralysis \n\n Never having been on a bicycle, and incapable of pedaling well", - "brief_summary": "The purpose of this study is to verify the efficacy of speed-feedback therapy in improving the cognitive function of elderly people with dementia by a randomized controlled trial, and to demonstrate how that affects ADL and QOL.", - "NCTID": "NCT00450047" - }, - { - "brief_title": "Effect of Panax Ginseng on the Cognitive Performance in Alzheimer's Disease", - "phase": "Phase 1; Phase 2", - "drugs": "['Panax Ginseng']", - "drugs_list": [ - "Panax Ginseng" - ], - "diseases": "[\"Alzheimer's Disease\", 'Memory Decline']", - "diseases_list": [ - "Alzheimer's Disease", - "Memory Decline" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Alzheimer's disease \n\n ", - "exclusion_criteria": ": \n\n other neurologic disease", - "brief_summary": "We investigate the clinical efficacy of Panax ginseng in Alzheimer's disease (AD).", - "NCTID": "NCT00391833" - }, - { - "brief_title": "Experimental Study to Validate the Therapeutic Game CONEM-BETA", - "phase": "", - "drugs": "['CONEM-BETA + socio-educational training', 'Socio-educational training only']", - "drugs_list": [ - "CONEM-BETA + socio-educational training", - "Socio-educational training only" - ], - "diseases": "[\"Alzheimer's Disease\", 'Dementia']", - "diseases_list": [ - "Alzheimer's Disease", - "Dementia" - ], - "enrollment": "101.0", - "inclusion_criteria": "inclusion criteria Family Caregivers: \n\n to be a family caregiver of an person diagnosed with possible or probable Alzheimer's disease or other advanced stage dementia \n\n show interest in participating \n\n Sign informed consent \n\n inclusion criteria Alzheimer's or dementia person: \n\n to have a probable or possible Alzheimer type dementia or other advanced dementia according to a diagnosis done by a Specialized Evaluation Unit \n\n GDS 5-6 and a minimental equal or lower than 12. \n\n to preserve a verbal comprehension of basic instructions \n\n to preserve the mobility of the arms, as well as the visual and auditive capacities that allow to conduct the activities. \n\n ", - "exclusion_criteria": " Caregivers: \n\n to have a negative attitude towards the emotional interaction with his/her Alzheimer or dementia family member \n\n Unavailability \n\n to participate in other socio-educative interventions during the study period. \n\n Any other situation that makes the caregiver as not suitable according to investigator's criteria \n\n ", - "brief_summary": "The purpose of the study is to assess the efficacy of the systematic application of the CONEM-BETA game in the subjective welfare of family caregivers of patients with Alzheimer's disease or other advanced stage dementia.", - "NCTID": "NCT01652222" - }, - { - "brief_title": "Care Management for Patients With Alzheimer Disease and Their Family Caregivers", - "phase": "", - "drugs": "['care management']", - "drugs_list": [ - "care management" - ], - "diseases": "[\"Alzheimer's Disease\", 'Dementia']", - "diseases_list": [ - "Alzheimer's Disease", - "Dementia" - ], - "enrollment": "220.0", - "inclusion_criteria": "inclusion criteria: \n\n Alzheimers Disease \n\n ", - "exclusion_criteria": ": \n\n Inability to understand English \n\n No telephone", - "brief_summary": "This is a clinical trial to test the effectiveness of current guideline for the care of older adults with Alzheimer's disease. The study focuses on the primary care setting using a nurse care manager to facilitate guideline-level care. We are hypothesizing that patients who receive guideline-level care will have fewer behavioral problems than those who receive the usual care provided in primary care settings", - "NCTID": "NCT00246896" - }, - { - "brief_title": "e-CHAMP: Enhancing Care for Hospitalized Older Adults With Memory Problems", - "phase": "", - "drugs": "['e-CHAMP (Enhancing Care for Hospitalized Older Adults with Cognitive Impairment)', 'Standard Care']", - "drugs_list": [ - "e-CHAMP (Enhancing Care for Hospitalized Older Adults with Cognitive Impairment)", - "Standard Care" - ], - "diseases": "['Cognitive Impairment', 'Delirium']", - "diseases_list": [ - "Cognitive Impairment", - "Delirium" - ], - "enrollment": "424.0", - "inclusion_criteria": "inclusion criteria: \n\n 65 years of age or older \n\n Hospitalized in a medical ward \n\n Able to speak English \n\n Cognitive impairment based on screening at time of hospital admission \n\n ", - "exclusion_criteria": ": \n\n Previously enrolled in the study during prior hospitalization (for multiple admissions; only data from the first admission will be used) \n\n Enrolled in another clinical trial \n\n Does not have cognitive impairment based on screening at time of hospital admission", - "brief_summary": "The purpose of this study is to evaluate the effectiveness of a cognitive screening program coupled with a computerized decision support system in improving the quality of care for hospitalized older adults with cognitive impairment.", - "NCTID": "NCT00182832" - }, - { - "brief_title": "Impact of Therapeutic Educational Programme on the Alzheimer's Disease Affected Patient's Quality of Life", - "phase": "", - "drugs": "['Therapeutic Educational Program']", - "drugs_list": [ - "Therapeutic Educational Program" - ], - "diseases": "['Alzheimer Disease']", - "diseases_list": [ - "Alzheimer Disease" - ], - "enrollment": "170.0", - "inclusion_criteria": "inclusion criteria: \n\n patient suffering from mild to moderately severe Alzheimer's disease patients (MMSE 11 to 26) \n\n in community dwelling \n\n with an informal caregiver (person living with the patient or providing care 3 times a week or 8 hours per week) \n\n is informed and has given his/her consent \n\n whom caregiver is informed and has given his/her consent \n\n ", - "exclusion_criteria": ": \n\n patient with other type of dementia \n\n living in nursing home or long term care \n\n with no caregiver \n\n not informed or has not given his/her consent \n\n whom caregiver is not informed or has not given his/her consent", - "brief_summary": "Therapeutic education expands in Alzheimer's Disease management in France. Several studies revealed a positive impact on caregiver's burden and/or quality of life. The purpose of this study, is to determine whether a therapeutic educational programme for both AD patients and primary caregivers, in community dwelling, improves patient's quality of life.", - "NCTID": "NCT01796314" - }, - { - "brief_title": "Study of Adherence and Effects of Balance Exercices (SIEL BLEU Associatio)", - "phase": "", - "drugs": "['Workshop balances']", - "drugs_list": [ - "Workshop balances" - ], - "diseases": "['Gait Apraxia', 'Alzheimer Disease', 'Impaired Cognition']", - "diseases_list": [ - "Gait Apraxia", - "Alzheimer Disease", - "Impaired Cognition" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of Alzheimer's disease (AD) (DSM-IV/NINCDS-ADRDA criteria) \n\n Age \u2265 65 years old \n\n Mild AD (Mini-Mental State Examination score between 21 and 25), moderate AD (Mini-Mental State Examination score between 10 and 20) and severe AD (Mini-Mental State Examination score between 3 and 9) \n\n Able to walk without any aid on 15 meters. \n\n Near visual acuity \u2265 2 \n\n Absence of severe depression (score of the 15-item Geriatric Depression Scale \u2264 10) \n\n Written consent form to participate in the study (or trustworthy person or legal representative for severe AD) \n\n Being affiliated to a social security regime \n\n ", - "exclusion_criteria": ": \n\n Musculoskeletal disorders not related to Alzheimer's disease \n\n Near visual acuity < 2 \n\n History of cerebrovascular accident or other cerebro-spinal pathology \n\n Poor workmanship of the written or oral French language \n\n Refusal to be informed on possible hanging bare anomaly during study \n\n Score of Mini-Mental State Examination < 3 \n\n Presence of severe depression (score of the 15-item Geriatric Depression scale > 10) \n\n Use of walking aid \n\n Subject suffering from pre-existing impellent disturbances \n\n Refusal to participate (or trustworthy person or legal representative)", - "brief_summary": "The purpose of this study is to measure the adherence to Siel bleu balance exercises in patients with Alzheimer's disease, while taking into account the disease stages.", - "NCTID": "NCT01314638" - } - ] - }, - { - "patient_id": "sigir-201521", - "patient": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", - "0": [ - { - "brief_title": "A Study of Nitazoxanide in Patients With AIDS and Diarrhea Caused by Cryptosporidium", - "phase": "Phase 2", - "drugs": "['Nitazoxanide']", - "drugs_list": [ - "Nitazoxanide" - ], - "diseases": "['Cryptosporidiosis', 'HIV Infections']", - "diseases_list": [ - "Cryptosporidiosis", - "HIV Infections" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria \n\n Patients must have: \n\n Documented HIV infection. \n\n Intestinal cryptosporidiosis. \n\n Willingness to undergo a 1 week washout phase of all anticryptosporidial medications and stabilization on a protocol directed, antidiarrheal regimen. \n\n Greater than or equal to 4 stools per day, on average, for a minimum of 21 out of 28 days prior to study entry, secondary to cryptosporidiosis. \n\n AS PER AMENDMENT 2/10/97: \n\n Four or more stools per day, on average, during the 5-day screening period prior to baseline. \n\n ", - "exclusion_criteria": " \n\n Co-existing Condition: \n\n Patients with the following symptoms and conditions are excluded: \n\n Inability to tolerate oral medications. \n\n Life expectancy less than 3 months in the opinion of the investigator. \n\n Active CMV colitis, C. difficile colitis, giardiasis, salmonellosis, shigellosis, campylobacteriosis, inflammatory bowel disease, diarrhea secondary to another documented intestinal pathogen, or active or uncontrolled MAC disease, defined as symptomatic MAC disease and/or a patient who is not on appropriate anti-MAC therapy in the presence of MAC disease. \n\n NOTE: \n\n Patients who have been treated for MAC disease for at least 4 weeks and have resolved their symptoms may be enrolled. Patients dually infected with microsporidiosis may be randomized to the study but will not count toward the sample size. \n\n AS PER AMENDMENT 2/10/97: \n\n Failure to record a minimum of four days of information on the use of antidiarrheal medication and the frequency of bowel movements in the daily diary during the screening period. \n\n Allergy to corn or corn products. \n\n Concurrent Medication: \n\n Excluded: \n\n Need for continuing use of any medications with putative anticryptosporidial activity, including paromomycin, azithromycin, clarithromycin, spiramycin, bovine colostrum, monoclonal anticryptosporidial antibody preparations, letrazuril, atovaquone, diclazuril, octreotide and albendazole (prohibited during the acute treatment phase for patients dually infected with microsporidiosis).. \n\n NOTE: \n\n Patients who develop cryptosporidiosis while taking azithromycin or clarithromycin may be enrolled as long as they have been taking those medications for at least four weeks and remain on a stable dosage. \n\n All antidiarrheals that are not part of the protocol directed Antidiarrheal Stabilization Regimen. \n\n The addition of any new antiretroviral agent or immunomodulator therapy the first 63 days on the study. \n\n Prior Medication: \n\n Excluded: \n\n Treatment at any time prior with nitazoxanide. \n\n Addition of any new antiretroviral or increase in the dosage or current antiretrovirals within 4 weeks to study entry.", - "brief_summary": "To determine the frequency of complete, marked, and partial clinical responses in patients with cryptosporidiosis treated with 6 weeks of NTZ versus 21 days of placebo. To determine the safety of NTZ in subjects with cryptosporidiosis.~There is no proven therapy for cryptosporidiosis in persons with AIDS. Nitazoxanide appears to be a good candidate drug for further evaluation because of its effectiveness in preclinical models, the data from early clinical trials and its safety profile. Cooperation between clinical researchers and basic scientists in clinical trials of agents for HIV infection and its complications is a high priority for the ACTG, the NIAID, and the NIH. Thus, it is important to design a clinical trial of NTZ that includes cooperation with basic scientists.", - "NCTID": "NCT00001081" - }, - { - "brief_title": "A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Bovine Anti-Cryptosporidium Immunoglobulin (BACI) in the Treatment of Cryptosporidium Enteritis in AIDS Patients", - "phase": "Phase 1", - "drugs": "['Cryptosporidium Immune Whey Protein Concentrate (Bovine)']", - "drugs_list": [ - "Cryptosporidium Immune Whey Protein Concentrate (Bovine)" - ], - "diseases": "['Cryptosporidiosis', 'HIV Infections']", - "diseases_list": [ - "Cryptosporidiosis", - "HIV Infections" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria \n\n Concurrent Medication: \n\n Allowed: \n\n Antidiarrheal compounds (if dose remains stable). \n\n Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC), or alternative HIV therapy (provided dose was stable for at least 4 weeks prior to study entry). \n\n Patients must have: \n\n AIDS. \n\n Cryptosporidium parvum enteritis. \n\n Chronic diarrhea. \n\n Life expectancy of at least 4 weeks. \n\n Ability to tolerate food by mouth. \n\n Ability to take the histamine H2-receptor antagonist famotidine (Pepcid). \n\n Prior Medication: \n\n Allowed: \n\n Antidiarrheal compounds (provided dose has remained stable in the 7 days prior to study entry). \n\n Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC), or alternative HIV therapy (provided dose has remained stable for at least 4 weeks prior to study entry). \n\n ", - "exclusion_criteria": " \n\n Co-existing Condition: \n\n Patients with the following symptoms or conditions are excluded: \n\n Concurrent unresolved clinical infections with enteric pathogens other than C. parvum (e.g., rotavirus, Salmonella, Shigella, Campylobacter, Giardia, C. difficile toxin, Yersinia, amebiasis, MAI, CMV, Microsporida) as determined by history or routine microbiology screening. \n\n Other acute infections or concurrent immediately life-threatening medical crisis other than cryptosporidiosis. \n\n Grossly bloody diarrhea. \n\n Known allergy to milk or milk products (other than lactose intolerance). \n\n Prior Medication: \n\n Excluded: \n\n Other experimental therapy (e.g., macrolide antibiotics, paromomycin) within 30 days prior to study entry.", - "brief_summary": "PRIMARY: To assess the effect of bovine anti-Cryptosporidium immunoglobulin (BACI) on the volume of diarrhea due to Cryptosporidium parvum in AIDS patients who have protracted Cryptosporidium enteritis.~SECONDARY: To assess changes in stool consistency and frequency, body weight, and safety in this patient population.", - "NCTID": "NCT00002248" - }, - { - "brief_title": "Transmission and the Respiratory Tract in Cryptosporidiosis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cryptosporidiosis']", - "diseases_list": [ - "Cryptosporidiosis" - ], - "enrollment": "480.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female children aged 9-36 months at the time of enrollment \n\n Presence of acute or persistent diarrhea (diarrhea defined as 3 or more loose stool in the previous 24 hours AND not considered normal for that child if the child is exclusively breast fed OR any number of bloody stools in the previous 24 hours; less than or equal to 14 days duration for acute diarrhea; >14 days duration for persistent diarrhea) \n\n Child's parent/guardian speaks English or Luganda \n\n Parent/guardian provides full and free informed consent for child to participate in study \n\n ", - "exclusion_criteria": ": \n\n Unknown age \n\n Known cardiac, CNS, metabolic or endocrine disorders \n\n Moribund children \n\n Children with recent history of choking or sudden onset of symptoms with suspected foreign body inhalation", - "brief_summary": "Cryptosporidium is an intestinal parasite that causes diarrhea in children and adults. In addition to infection of the stomach, this parasite can infect the respiratory system causing a cough and/or problems breathing. This study will enroll 480 children between the ages of 9 and 36 months who come to Mulago Hospital for treatment of diarrhea. Researchers believe a large number of children with diarrhea and cough will have the parasite present in their sputum (mucus coughed up). Researchers also believe that children who have respiratory tract cryptosporidiosis may have a cough, increased number of breaths per minute, and/or a lower oxygen level. Blood, stool, saliva, and sputum samples will be collected from all children in the study and tested for Cryptosporidium. Children too young to provide a sputum sample will have a tube placed to collect a mucus sample from the lungs. Study participation may be as short as 4 hours or as long as 2 days depending on each child's health.", - "NCTID": "NCT00507871" - }, - { - "brief_title": "A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea", - "phase": "Phase 1", - "drugs": "['Nitazoxanide']", - "drugs_list": [ - "Nitazoxanide" - ], - "diseases": "['HIV Infections']", - "diseases_list": [ - "HIV Infections" - ], - "enrollment": "28.0", - "inclusion_criteria": "inclusion criteria \n\n Patients must have: \n\n AIDS diagnosis according to CDC criteria. \n\n CD4 count less than or equal to 200 cells/mm3 or CD4 count greater than or equal to 200 cells/mm3 and documented cryptosporidiosis for a minimum of 4 weeks. \n\n Cryptosporidial diarrhea as defined by: \n\n (1) presence of Cryptosporidium oocytes in a stool specimen within 14 days of enrollment; and (2) chronic diarrhea (i.e., an average of at least 4 bowel movements per day for a minimum of 2 weeks). \n\n Life expectancy of at least 1 month. \n\n Ability to tolerate food by mouth. \n\n Prior Medication: \n\n Required: \n\n Any anti-diarrheal or anti-emetic medication for which the dosage regimen has been stable for at least 1 week prior to enrollment. \n\n Any antiretroviral medications (e.g., zidovudine, ddI, ddC) for which the dosage regimen has been stable for at least 3 weeks prior to enrollment. \n\n Allowed: \n\n Medication for prophylaxis or maintenance therapy of opportunistic infection, stable for at least 2 weeks prior to enrollment. \n\n ", - "exclusion_criteria": " \n\n Co-existing Condition: \n\n Patients with the following symptoms or conditions are excluded: \n\n Grade 4 (hematologic) or Grade 3 (for all others) toxicity. (Patients with Grade 3 toxicity for hepatic parameters may be enrolled if, in the investigator's judgment, the abnormalities are due to biliary cryptosporidiosis.) \n\n Patients with the following prior conditions are excluded: \n\n Presence of Salmonella, Shigella, Campylobacter, Yersinia, Giardia lamblia, Entamoeba histolytica, Microsporidia, Isospora, Cyclospora, or Clostridium difficile toxin in stool (based on assessment within 14 days prior to enrollment by stool ova and parasite examination, culture, and C. difficile assay). \n\n History of intestinal Mycobacterium avium intracellular infection or intestinal Kaposi's sarcoma. \n\n History of Cytomegalovirus colitis, unless 28 days of therapy with ganciclovir or foscarnet completed subsequent to diagnosis. \n\n Prior Medication: \n\n Excluded: \n\n Investigational drug therapy within 14 days of enrollment, unless available under an FDA-authorized expanded access program. \n\n Any drug or therapy with possible anticryptosporidial activity (e.g., paromomycin, spiramycin, azithromycin, clarithromycin, hyperimmune bovine colostrum) within 14 days of enrollment.", - "brief_summary": "To determine the pharmacokinetics profile of single doses of nitazoxanide (NTZ) in patients with AIDS-related cryptosporidial diarrhea. To determine steady state concentrations of NTZ following repeated dosing. To assess the safety and efficacy of 4 dose levels of NTZ in these patients.~Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe, contributing substantially to morbidity, mortality, and health care costs in this population. NTZ exhibits antimicrobial activity that may extend to Cryptosporidial infection.", - "NCTID": "NCT00002444" - }, - { - "brief_title": "A Double-Blind, Placebo-Controlled Trial of Albendazole in HIV-Positive Patients With Intestinal Microsporidiosis", - "phase": "Phase 3", - "drugs": "['Albendazole']", - "drugs_list": [ - "Albendazole" - ], - "diseases": "['Protozoan Infections', 'HIV Infections']", - "diseases_list": [ - "Protozoan Infections", - "HIV Infections" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria \n\n Concurrent Medication: \n\n Required: \n\n If coincident enteric pathogens that are not eradicable (i.e., Mycobacterium avium complex) are detected, they should be treated appropriately and the patient must be on a stable regimen of therapy for at least two weeks. \n\n Allowed: \n\n Patients taking antidiarrheal medications must be on a stable regimen for at least seven days prior to randomization. \n\n Patients taking other concomitant medications, including antiretrovirals, must be on a stable regimen for two weeks prior to randomization. \n\n Patients must have: \n\n HIV positive status. Written documentation (for example, patient's chart) of HIV diagnosis is acceptable in lieu of repeat testing. Confirmation by Western blot is not necessary. \n\n Biopsy-proven microsporidiosis of the fourth portion of the duodenum or proximal jejunum within 90 days before randomization. \n\n Average of > 3 liquid bowel movements per day over 7 consecutive days immediately prior to randomization, with an average volume > 500 ml per day over three or more consecutive days immediately prior to randomization, as documented by data collected in a daily diary. NOTE: \n\n Patients receiving antidiarrheal therapy must meet these criteria despite such therapy. \n\n History of an average of > 3 liquid bowel movements per day for three additional weeks immediately preceding the 7-day period described above (for a total of four weeks), as documented in the patient's chart. \n\n ", - "exclusion_criteria": " \n\n Co-existing Condition: \n\n Patients with the following symptoms or conditions are excluded: \n\n Grade 4 neutropenia. \n\n Decompensated liver disease. \n\n Positive toxin analysis for C. difficile. \n\n Positive microscopic examination for Giardia lamblia, Entamoeba histolytica, and Isospora belli. \n\n Positive on culture for Shigella, Salmonella, Yersinia and Campylobacter. \n\n Positive fluorescent antibody test for Cryptosporidium. \n\n Evidence of CMV on small bowel biopsy, flexible sigmoidoscopic or colonoscopic biopsies within 90 days of randomization. \n\n Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study entry. \n\n Patients with the following prior conditions are excluded: \n\n Hypersensitivity to albendazole. \n\n Prior Medication: \n\n Excluded: \n\n Use of potential antiprotozoal drugs, e.g., mebendazole or metronidazole, within one week prior to enrollment. \n\n Receipt of albendazole during the one month prior to enrollment.", - "brief_summary": "To evaluate the efficacy (stool frequency) and safety (adverse experiences) of albendazole, administered for 28 days, compared to placebo and for 62 days in open-label fashion, in treating intestinal microsporidiosis in HIV-positive patients. To assess the effect of albendazole on stool volume, weight gain, microsporidial counts in small bowel biopsies, and on the relationship between microsporidial counts in stool and stool frequency and volume. To correlate microsporidial counts with the clinical course of microsporidiosis.", - "NCTID": "NCT00002191" - }, - { - "brief_title": "Microbiome Changes in Travelers to Tropical Destinations", - "phase": "", - "drugs": "['feces sample']", - "drugs_list": [ - "feces sample" - ], - "diseases": "['Intestinal Diseases']", - "diseases_list": [ - "Intestinal Diseases" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Travelers who intended to travel to tropical areas \n\n Good general health \n\n ", - "exclusion_criteria": ": \n\n Medication consumption \n\n Background diseases", - "brief_summary": "The human gut contain a wide range of microorganisms creating the gut microbiome. The microbiome has great impact on metabolic and immunologic processes and responses. Travelers who travel to tropical destinations where the intestinal infection risk is high are prone to microbiome changes. During the current study the travelers will give feces specimen before and after the travel and their microbiome will be analyzed.", - "NCTID": "NCT02295254" - }, - { - "brief_title": "WASH Benefits Bangladesh", - "phase": "", - "drugs": "['Water quality', 'Sanitation', 'Hand washing', 'Water quality, Sanitation, Hand washing (Combined WASH)', 'Nutrition', 'Nutrition, Water quality, Sanitation, Hand washing']", - "drugs_list": [ - "Water quality", - "Sanitation", - "Hand washing", - "Water quality", - "Sanitation", - "Hand washing (Combined WASH)", - "Nutrition", - "Nutrition", - "Water quality", - "Sanitation", - "Hand washing" - ], - "diseases": "['Malnutrition', 'Diarrhea', 'Child Development']", - "diseases_list": [ - "Malnutrition", - "Diarrhea", - "Child Development" - ], - "enrollment": "5040.0", - "inclusion_criteria": "inclusion criteria: \n\n (1) Infants (target child) will be eligible to participate in the study if they are: \n\n They are in utero at the baseline survey \n\n Their parents/guardians are planning to stay in the study village for the next 12 months (if a mother is planning to give birth at her natal home and then return, she will still be a candidate for enrollment) \n\n (2) Children < 36 months old at baseline that are living in the compound of a target child will be eligible to participate in diarrhea measurement if: \n\n They are < 36 months old at the baseline survey \n\n Their parents/guardians are planning to stay in the study village for the next 12 months \n\n (3) Children 18 - 27 months old at baseline that are living in the compound of a target child will be eligible to participate in intestinal parasite specimen collection if: \n\n They are 18 - 27 months old at the baseline survey \n\n Their parents/guardians are planning to stay in the study village for the next 12 months", - "exclusion_criteria": "", - "brief_summary": "Brief Summary:~The purpose of this study is to measure the independent and combined effects of interventions that improve water quality, sanitation, hand washing, and nutrition on child growth and development in the first years of life.", - "NCTID": "NCT01590095" - }, - { - "brief_title": "Efficacy of Bromopride and Simethicone Versus Bromopride in Functional Dyspepsia", - "phase": "Phase 3", - "drugs": "['FDC Bromopride 10 mg and Simethicone 80 mg', 'Bromopride 10 mg']", - "drugs_list": [ - "FDC Bromopride 10 mg and Simethicone 80 mg", - "Bromopride 10 mg" - ], - "diseases": "['Dyspepsia']", - "diseases_list": [ - "Dyspepsia" - ], - "enrollment": "339.0", - "inclusion_criteria": "inclusion criteria: \n\n Signed Informed Consent; \n\n Participants aged 18- 70 years; \n\n Clinical diagnosis of functional dyspepsia according to Rome III criteria; \n\n Minimum score of 22 points in PADYQ questionnaire \n\n ", - "exclusion_criteria": ": \n\n Diagnosis of gastroesophageal reflux disease, irritable bowel syndrome, inflammatory bowel disease, gallstones, strongyloidiasis, giardiasis or ascariasis, clinical disease or significant psychological; \n\n Positive diagnosis for Helicobacter pylori; \n\n Clinically significant organic diseases in the HDE (High Digestive Endoscopy) prior to randomization; \n\n History of esophageal surgery, gastrointestinal or other intra-abdominal surgery; \n\n Hypersensitivity to the components of the formulations; \n\n Allergy tartrazine yellow dye; \n\n Allergy to aspirin; \n\n Use of PPIs, H2 blockers, prokinetics, antibiotics, prostaglandins or bismuth salts in the last week before the screening visit; \n\n Use of NSAIDs or aspirin more than two days a week (except AAS <325mg / day), other drugs that induce gastrointestinal symptoms; \n\n Pregnant women or women without adequate contraception; \n\n Advance Participation in clinical trial protocols in the last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, subsection J), unless the investigator considers that there may be direct benefit to it; \n\n Changes in hematological and biochemical tests: hemoglobin less than 12 g / dl, results with value 2 times the reference for AST, ALT, Gamma GT and alkaline phosphatase; \n\n Diagnosis of neurological or psychiatric diseases or decompensated diabetes; \n\n Use of drugs with anticholinergic action, narcotic analgesics, sedatives, hypnotics or tranquilizers; \n\n Alcoholism or sporadic use of alcohol and illicit drug use.", - "brief_summary": "Multi-center, randomized, superiority, double blind clinical trial to asses the efficacy of fixed-dose combination of bromopride and simethicone versus isolated bromopride on research participants diagnosed with functional dyspepsia.", - "NCTID": "NCT02604576" - }, - { - "brief_title": "Secondary Lactose Intolerance Due to Chronic Norovirus Infection", - "phase": "", - "drugs": "['Lactose H2 breath test (LH2BT)']", - "drugs_list": [ - "Lactose H2 breath test (LH2BT)" - ], - "diseases": "['Chronic Diarrhea']", - "diseases_list": [ - "Chronic Diarrhea" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria: \n\n - Renal transplant recipient (RTR) with proven diagnosis of chronic norovirus infection, whereas chronic virus shedding is defined as more than two polymerase chain reaction (PCR) positive samples in an interval of at least one month (case group) or chronic diarrhoea defined as more than three bowel movements per day since more than four weeks (control group). \n\n ", - "exclusion_criteria": ": \n\n Missing informed consent. \n\n Primary lactose intolerance. \n\n Concomitant intestinal infection (other than norovirus). \n\n Subjects with galactosemia or patients requiring a low galactose diet. \n\n Age < 18 years.", - "brief_summary": "The objective of this study is to determine the prevalence of secondary lactose intolerance in renal transplant recipients (RTR) with chronic norovirus infection.~In the investigators cohort of 1000 renal transplant recipients (RTRs) in the University Hospital of Zurich, the investigators are currently aware of 10 patients with chronic norovirus infection, which was proven by positive polymerase chain reaction (PCR) analysis of recent stool samples, whereas chronic virus shedding is defined as more than two PCR positive samples in an interval of at least one month. Concomitant viral (other than norovirus), bacterial or parasitic (particularly Gardia lamblia) intestinal infections are excluded by negative stool cultures and PCR analyses, respectively. Main exclusion criterion for the present case series is a concomitant intestinal infection (other than norovirus) and primary lactose intolerance, which is previously excluded by absence of the CC genotype of the DNA variant -13910 T/C upstream in the LCT gene. After obtaining written and oral informed consent, the investigators perform a lactose hydrogen breath (LH2BT) test and a lactose tolerance test (LTT) in all eligible RTRs with proven chronic norovirus infection irrespective of current abdominal symptoms.~The study population (N=10) is divided into two groups according to the gastrointestinal symptoms (asymptomatic versus symptomatic, such as chronic diarrhoea or diffuse abdominal discomfort). The investigators chose the cut-off three or more stools per day as indicative of diarrhoea for the purpose of this study. RTRs with otherwise unexplainable chronic diarrhoea but absent norovirus infection serve as control group (N=10).", - "NCTID": "NCT01840891" - }, - { - "brief_title": "A Trial of Tap Water Treatment in the Elderly", - "phase": "", - "drugs": "['home drinking water treatment device']", - "drugs_list": [ - "home drinking water treatment device" - ], - "diseases": "['Diarrhea', 'Gastrointestinal Diseases']", - "diseases_list": [ - "Diarrhea", - "Gastrointestinal Diseases" - ], - "enrollment": "810.0", - "inclusion_criteria": "inclusion criteria \n\n 55 years or older \n\n primary source of drinking water used at home is supplied by Sonoma County Water Agency without use of home filtration device or bottled water \n\n all individuals living in the home must sign informed consent and agree to have the water treatment device installed \n\n no known immunocompromising conditions (including HIV/AIDS, active cancer, or transplant recipients). \n\n ", - "exclusion_criteria": ": \n\n persons with immunocompromising condition (including HIV/AIDS, active cancer, or transplant recipients) \n\n employees and family members of the Sonoma County Water Agency or a Sonoma County Water District", - "brief_summary": "This study is being conducted in Sonoma County, California.~Gastrointestinal illness and diarrhea are recognized as a significant cause of morbidity and mortality in the elderly. One study showed that 51% of deaths caused by diarrhea over a 9-year period occurred in individuals over the age of 74 years. Although many infectious diseases are more problematic in the elderly because of a decline in immune function and a higher incidence of pre-existing malnutrition and dehydration, it is still not known what the principal modes of transmission are and which infectious agents are responsible.~The principal objective of this study is to evaluate the ability of in-home treatment of tapwater to reduce gastrointestinal illness in non-institutionalized elderly individuals. The trial will test household-level treatment of drinking water by joint use of ultraviolet light and filtration devices. A secondary objective is an estimate of the incidence of specific bacterial, viral, and protozoan agents in stool specimens collected from elderly individuals with gastrointestinal symptoms that might be related to water consumption.", - "NCTID": "NCT00058942" - }, - { - "brief_title": "Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia", - "phase": "", - "drugs": "['Itopride,', 'Placebo']", - "drugs_list": [ - "Itopride,", - "Placebo" - ], - "diseases": "['Functional Dyspepsia', 'Gastric Emptying', 'Gastric Accommodation']", - "diseases_list": [ - "Functional Dyspepsia", - "Gastric Emptying", - "Gastric Accommodation" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n All adult male or non-pregnant female patients who are diagnosed as functional dyspepsia and fulfilling Rome III criteria (1) will be considered \n\n Patients should be negative for H. pylori on gastric biopsy and Urea Breath Test. \n\n duodenal biopsy in these patients should be negative for giardiasis or celiac disease or any other established organic pathology \n\n A normal upper abdominal ultrasound \n\n Willing to participate and give consent for participation in the study. \n\n ", - "exclusion_criteria": ": \n\n Age <18 years \n\n Helicobacter Pylori positive on gastric biopsy and / or UBT. \n\n Taking other medications that alter gastric motility like macrolide \n\n anti-emetics and antibiotics . \n\n Pregnant or breast-feeding females.", - "brief_summary": "Pathogenesis of functional dyspepsia is poorly understood. Gastrointestinal motor abnormalities, Helicobacter pylori infection, impaired gastric accommodation to a meal, hypersensitivity of the afferent nerves of the gut, psychological disturbances and central nervous system dysfunction have been proposed.~Pharmacological treatments for patients with functional dyspepsia remain unsatisfactory. Only small benefits relative to placebo have been found with histamine H2 receptor antagonists, proton pump inhibitor and Helicobacter pylori eradication.~Itopride is a dopamine antagonist with acetylcholinesterase inhibitory actions. This agent is currently indicated for patients with various upper GI symptoms.~This study is aimed to evaluate the effect of Itopride on gastric emptying(by 13-C Octanoic acid breath Test), accommodation (by Gastric Scintigraphy SPECT and slow nutrient drinking test)and symptoms in FD patients", - "NCTID": "NCT01226134" - }, - { - "brief_title": "Study to Evaluate Safety and Efficacy of Rifamycin SV Multi-Matrix System (MMX) for the Treatment of Traveler's Diarrhea (TD)", - "phase": "Phase 3", - "drugs": "['Placebo', 'Rifamycin SV MMX']", - "drugs_list": [ - "Placebo", - "Rifamycin SV MMX" - ], - "diseases": "[\"Traveler's Diarrhea\"]", - "diseases_list": [ - "Traveler's Diarrhea" - ], - "enrollment": "264.0", - "inclusion_criteria": "inclusion criteria \n\n Patients were enrolled in the study only if they met all of the following criteria: \n\n Male and female patients 18 years of age or older \n\n Female and male patients of childbearing potential must have agreed to use an effective method of birth control (this method must have been approved by the investigator and may have included total abstinence from sexual intercourse) during the treatment and follow-up study periods; female patients of childbearing potential must have had a negative pregnancy test in the 72 hours before randomization; female patients who abstained totally from sexual intercourse were not required to take the pregnancy test \n\n Recent travel (i.e., must be within 30 days of randomization) from an industrialized country \n\n Experiencing signs or symptoms indicative of acute bacterial diarrhea (TD), defined as at least three unformed, watery or soft, stools within the 24 hours preceding randomization and the duration of illness 72 hours before randomization, and able to provide an unformed stool sample during Screening (the latter can be the third unformed stool passed by the patient within the 24 hours preceding randomization); the bacterial cause of diarrhea was confirmed by microbiology analysis of the stool sample \n\n Experiencing one or more signs or symptoms of enteric infection (moderate to severe gas/flatulence, nausea, vomiting, abdominal cramps or pain, rectal tenesmus, or defecation urgency) \n\n Capable of and willing to give informed consent \n\n ", - "exclusion_criteria": " \n\n Patients were excluded from the study if they met any of the following criteria: \n\n Fever (> 100.4F or 38C) or presence of signs and symptoms of systemic infection Note: antipyretic medication should not have been administered in the 6 hours before this assessment \n\n Known or suspected infection with non-bacterial pathogen before randomization \n\n Presence of diarrhea for > 72 hours duration \n\n Presence of grossly bloody stool \n\n Presence of moderate to severe dehydration (i.e., presence of orthostatic hypotension and/or dehydration requiring treatment with intravenous fluids) \n\n History of ulcerative colitis, diarrhea-predominant irritable bowel syndrome, Crohn's disease, celiac sprue (gluten-enteropathy), chronic pancreatitis, malabsorption, or any other gastrointestinal disease associated with diarrhea. Note: lactose intolerance treated with lactase supplements or a lactose-free diet were not excluded if these regimens were maintained during the study. \n\n Receiving more than two doses of an antidiarrheal medication (e.g., antimotility, absorbent, adsorbent, antisecretory, or probiotics) within 24 hours before randomization \n\n Receiving one or more of the following antibiotics, which are active against gram negative bacteria TMP-SMX, fluorquinolone, azithromycin or rifaximin within 7 days before randomization \n\n Females pregnant or breast feeding or not using adequate birth control \n\n Known intolerance/hypersensitivity/resistance to rifamycin or rifamycin-related antibiotics or to any excipient included in the study medications \n\n Patients unable or unwilling to comply with study protocol (e.g., alcoholism, mental illness, travel schedule) \n\n Participation in a clinical study with another investigational drug in the 30 days prior to randomization or while participating in this study \n\n Previous participation in this study", - "brief_summary": "The purpose of this study is to determine whether Rifamycin SV MMX is a safe and effective treatment for Traveler's Diarrhea.", - "NCTID": "NCT01142089" - }, - { - "brief_title": "Relative Efficacy of Two Regimens of Ante-helminthic Treatment", - "phase": "", - "drugs": "['Albendazole']", - "drugs_list": [ - "Albendazole" - ], - "diseases": "['Helminthiasis']", - "diseases_list": [ - "Helminthiasis" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria:The inclusion criteria are; \n\n age of the child is 2-5 years old, \n\n he/she has not been suffering from serious chronic illness, \n\n the child stool test must be positive for STH, \n\n he/she had not been taken any antehelminthic drug in the previous six months, \n\n parents/guardian are agree for their child participation in the study. e - \n\n ", - "exclusion_criteria": ": \n\n age of the child less than 2 years old and more than 5 years old, \n\n his/her stool test negative for any intestinal helminth, \n\n he/she has been suffering from serious chronic illness, \n\n parents/guardian are not willing to give consent for their child's participation in the study, \n\n if he/she receives any antehelminthic drug after survey but before the study interventions.", - "brief_summary": "The most common soil transmitted helminthic infections(STHI) includes infection with Ascaris lumbricoides, Trichuris trichiura, and Hookworm. Growth retardation, malnutrition, anemia, impaired cognitive function and immunosuppression are main manifestations in children. Even within the developing world, wide differences exist in prevalence rates. The poorest countries have higher levels of STHI than those with a lower incidence of poverty. According to an estimate made by the WHO, the prevalence of A. lumbricoides, T. trichiura and Hookworm in South Asia was 27%, 20% and 16% respectively. Given that the prevalence of STHI in urban slums in Bangladesh is much higher than the other parts of the world and Asia and that there are major health and socio-economic consequences of such infections, it is important that we come up with effective means of reducing the prevalence of such infections. 60-80% of preschool children in urban slums of Bangladesh are infected with these STHI due to poor hygiene . At present deworming at six months interval is recommended but the effectiveness of this regimen of dewormig is questionable.~2. Hypothesis: Ante-helminthic treatment at every three month is more effective than ante-helminthic treatment at every six months to reduce soil transmitted helminthic infection, to reduce diarrheal and respiratory illness to improve nutritional status in preschool children.~3.Objective: The main objectives of the proposed study is to compare the relative efficacy of two different ante-helminthic treatment regimens to reduce the prevalence of STHI, diarrheal diseases, respiratory illness and to improve nutritional status in children 4. Design: The population of the study will be preschool children aged 2-5 year and will be selected randomly from an urban of Dhaka. They will be divided into two groups randomly. One group will get ante-helminthic at every three months interval and the other groups will get at six months interval for one year. Stool samples will be collected at the baseline and after three months completing one-year treatment of the above mentioned regimen. Blood haemoglobulin and nutritional status will also be measured at baseline and after three months of completion of treatment as mentioned above. The treatment will be 400 mg of Albendazole in a single dose.~5. Potential Impact: The findings of the research can be implemented by the government and non-government organization.", - "NCTID": "NCT00367627" - }, - { - "brief_title": "Safety Study of Live Attenuated Oral Shigella (WRSS1) Vaccine in Bangladeshi Adults and Children", - "phase": "", - "drugs": "['WRSS1']", - "drugs_list": [ - "WRSS1" - ], - "diseases": "['Diarrhea']", - "diseases_list": [ - "Diarrhea" - ], - "enrollment": "103.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy male or female adults from 18-39 years old, inclusive \n\n General good health as determined by the screening evaluation no greater than 30 days before admission \n\n Properly informed about the study, able to understand it and sign the informed consent form \n\n Normal bowel habits (< 3 grade 1 or 2 stools each day; \u2265 1 grade 1 or 2 stools every 2 days) \n\n Free of obvious health problems as established by medical history and clinical examination before entering into the study. \n\n Available for the entire period of the study and reachable by study staff throughout the entire follow-up period \n\n Females of childbearing potential who are willing to take a serum pregnancy test at screening and urine pregnancy tests before each vaccination. Pregnancy tests must be negative before each vaccination. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is also acceptable. \n\n Signed Informed Consent \n\n ", - "exclusion_criteria": ": \n\n Presence of a significant medical or psychiatric condition that in the opinion of the Investigator precludes participation in the study \n\n Known infection with Hepatitis C or Human Immunodeficiency Virus (HIV) \n\n History of congenital abdominal disorders, intussusception, abdominal surgery or any other congenital disorder. \n\n Participation in research involving another investigational product (defined as receipt of investigational product) 30 days before planned date of first vaccination or concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational product \n\n Clinically significant abnormalities on physical examination \n\n Clinically significant abnormalities in screening hematology, serum chemistry, or urinalysis as determined by the PI or the PI in consultation with the Study Physician \n\n History of febrile illness within 48 hours prior to vaccination \n\n Known or suspected impairment of immunological function based on medical history and physical examination \n\n Prior receipt of any Shigella vaccine \n\n Fever at the time of immunization. Fever is defined as a temperature \u2265 37.5 degrees Celsius (99.5 degrees Fahrenheit) on axillary, oral, or tympanic measurement \n\n Clinical evidence of active gastrointestinal illness \n\n Prior receipt of a blood transfusion or blood products, including immunoglobulins \n\n Presence of any significant systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would endanger the participant's health or is likely to result in non-conformance to the protocol. \n\n History of any neurologic disorders or seizures. \n\n Acute disease at the time of enrolment \n\n Evidence of current excessive alcohol consumption \n\n Evidence of current illicit drug use or drug dependence \n\n Current use of iron or zinc supplements within the past 7 days; current use of antacids (Histamine H2-receptor antagonists (H2 blockers), Omeprazole, over the counter (OTC) agents) or immunosuppressive drug \n\n Allergy to quinolone, sulfa, and penicillin classes of antibiotics \n\n History of any of the following conditions within the past 10 years: \n\n Arthritis (two or more episodes of joint pain and swelling) \n\n Gastrointestinal disease (diagnosed by a doctor as having irritable bowel disease, Crohn's disease, ulcerative colitis (biopsy confirmed), celiac disease, stomach or intestinal ulcers \n\n Dyspepsia (indigestion or heartburn requiring medication more than once per week) \n\n History of gallbladder disease \n\n History of chronic heart disease \n\n Any conditions which, in the opinion of the investigator, might jeopardize the safety of study participants or interfere with the evaluation of the study objectives \n\n Receipt of antimicrobial drugs for any reason or a fever \u2265 38 degrees Celsius within 7 days before vaccination \n\n History of diarrhea during the 7 days before vaccination. \n\n Has any household member(s) who is immunocompromised or under the age of 2 years old.", - "brief_summary": "This is a research study about an experimental (investigational) oral Shigella sonnei - Walter Reed S. sonnei (WRSS1). WRSS1 is a live vaccine that is being made to prevent disease from Shigella, which causes bloody, watery diarrhea. Infants and children living in developing countries experience the greatest consequences of this disease. The purpose of this study is to find a dose of the vaccine that is safe, tolerable, and develops an immune response. About 39 healthy adults, ages 18-39, and 48 healthy children, ages 5-9, will participate in this study. Once the vaccine is proven safe and tolerable in adults, then it will be tested in the children. This study will require volunteers to stay in the research facility for several nights for the first dose; they will not be required to stay overnight for the second and third doses. Participants will be assigned to receive 1 of 3 vaccine dose levels by mouth. Study procedures include: stool samples, blood samples and documenting side effects. Participants will be involved in study related procedures for about 8 months.", - "NCTID": "NCT01813071" - }, - { - "brief_title": "Safety and Immunogenicity of Single Dose Choleragarde\u00ae in HIV-Seropositive Adults", - "phase": "Phase 2", - "drugs": "['CholeraGarde\u00ae', 'Placebo']", - "drugs_list": [ - "CholeraGarde\u00ae", - "Placebo" - ], - "diseases": "['Cholera', 'Vibrio Infections', 'Diarrhea']", - "diseases_list": [ - "Cholera", - "Vibrio Infections", - "Diarrhea" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n HIV-seropositive, non-pregnant adults, aged 18 - 45 years old who have been on standard highly active antiretroviral therapy (HAART) for at least 6 months prior to enrollment or who have never started HAART regimen will be recruited in the study. \n\n All subjects must satisfy the following criteria at study entry: \n\n Male and female HIV seropositive adults aged 18 to 45 years old who have given the written informed consent. \n\n Will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection). \n\n CD4 T-lymphocyte count >500/mm3 for at least 6 months prior to inclusion \n\n Subjects that have never started HAART regimen must satisfy the following additional criteria at study entry. \n\n 1. Asymptomatic HIV infection as determined by: Medical history, Physical examination, Laboratory tests, Clinical judgment of the investigator \n\n Subjects that have been on standard highly active antiretroviral therapy (HAART) for at least 6 months prior to enrollment must satisfy the following additional criteria at study entry. \n\n History of CD4 nadir >150/mm3 \n\n Viral load (HIV-1 RNA levels) <200 copies/mL for at least 6 months prior to inclusion \n\n ", - "exclusion_criteria": ": \n\n The following criteria should be checked at the time of study entry, if any of the following is present then the subject will be excluded from the study: \n\n Overt signs of immunodeficiency e.g. oral thrush, rapid weight loss, recurrent pneumonia (i.e. Stage 3 or 4 of the WHO clinical staging system for HIV infection and disease in adults and adolescents \n\n Ongoing serious chronic illness (e.g. with signs of cardiac or renal failure) \n\n Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours \n\n Presence of V. cholerae 01 or 0139, Shigella, or Cryptosporidium in stool at baseline \n\n Intake of any anti-diarrhoeal medicine in the past week \n\n Acute disease one week prior to enrollment, with or without fever. Temperature \u226538\u00baC (oral or otic) warrants deferral of the vaccination pending recovery of the subject \n\n Receipt of antibiotics in the past 2 weeks \n\n Receipt of live or killed enteric vaccine in the last 4 weeks \n\n Receipt of killed oral cholera vaccine in the past \n\n Diarrhea (3 or more loose stools within a 24-hour period) 6 weeks prior to enrollment \n\n One or more episodes of diarrhea lasting for more than 2 weeks in the past 6 months \n\n One or more episodes of abdominal pain lasting for more than 2 weeks in the past 6 months \n\n Receipt of blood, blood products or a parenteral immunoglobulin preparation in the previous 6 months \n\n Receipt of any immunosuppressive therapy during the past 6 months \n\n A woman pregnant or planning to become pregnant during the period of subject's participation \n\n Any condition which in the opinion of the investigator, might interfere with the evaluation of the study objectives", - "brief_summary": "The purpose of this study is to assess the safety and immunogenicity of Peru-15 (CholeraGarde\u00ae) vaccine in HIV seropositive adult population of Bangkok Thailand", - "NCTID": "NCT00741637" - }, - { - "brief_title": "Proton Pump Inhibitors and Gastrointestinal Symptoms", - "phase": "Phase 4", - "drugs": "['Lactobacillus paracasei F19', 'Placebo']", - "drugs_list": [ - "Lactobacillus paracasei F19", - "Placebo" - ], - "diseases": "['Gastrointestinal Symptoms', 'Small Intestinal Overgrowth']", - "diseases_list": [ - "Gastrointestinal Symptoms", - "Small Intestinal Overgrowth" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n recent onset of typical reflux symptoms (heartburn and regurgitation). \n\n ", - "exclusion_criteria": ": \n\n age <18 or >70 yrs \n\n pregnancy or breast-feeding \n\n evidence of major concomitant diseases (i.e., tumors, cardiovascular disorders and hepatic and/or renal failure) \n\n use of PPIs or H2-antagonists, non-steroidal anti-inflammatory drugs (NSAIDs) or antibiotics in the previous 3 months \n\n presence of Helicobacter pylori (H. pylori) infection \n\n erosive esophagitis \n\n presence of bowel symptoms such as bloating, flatulence, abdominal pain, diarrhea and constipation in the last 6 months or irritable bowel syndrome (IBS) according to Rome III criteria.", - "brief_summary": "The aim of the study is to evaluate the potential protective effect of Lactobacillus paracasei subspecies paracasei F19 administration on bowel symptom onset in patients with gastro-esophageal reflux disease at long-term PPI treatment.", - "NCTID": "NCT02054455" - }, - { - "brief_title": "The Use of a Non-absorbable Marker for the Evaluation of the Gastrointestinal Transit", - "phase": "", - "drugs": "['Paromomycin Sulfate Fasted State', 'Paromomycin Sulfate Fed State', 'Paromomycin Sulfate w/ domperidone', 'Paromomycin Sulfate w/ loperamide HCl']", - "drugs_list": [ - "Paromomycin Sulfate Fasted State", - "Paromomycin Sulfate Fed State", - "Paromomycin Sulfate w/ domperidone", - "Paromomycin Sulfate w/ loperamide HCl" - ], - "diseases": "['Concentration-Time Profiles in Stomach & Intestine.']", - "diseases_list": [ - "Concentration-Time Profiles in Stomach & Intestine." - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy volunteers \n\n age: 20-35 year \n\n ", - "exclusion_criteria": ": \n\n Diseases \n\n Acute/chronic gastrointestinal disorders \n\n Medication use \n\n Possible pregnancy \n\n Frequent exposure to x-ray radiation during the past year \n\n HIV positive", - "brief_summary": "Aim of the study The aim of this study is to use Gabbroral\u00ae oral tablet formulation as marker for the evaluation of the gastrointestinal transit. By collecting and analyzing both gastric and intestinal fluids on different time points, the transfer dissolution can be distracted. For this study stomach fluid and intestinal fluid will be collected after oral intake of a commercially available dosing form of Paromomycin Sulfate (Gabbroral\u00ae oral tablet formulation), which is dissolved in a glas of 240mL water, in fasted or fed state. Four intake conditions will be tested on four different test days (with an intermediate period of at least 7 days).~intake of Gabbroral\u00ae oral tablet formulation, which will be dissolved in a glas of 240mL water, in fasted state.~intake of Gabbroral\u00ae oral tablet formulation in fed state.~Intake of 2 tablets of Motilium\u00ae (API: domperidone 10 mg) 20 minutes before the intake of Gabbroral\u00ae oral tablet formulation, which will be dissolved in a glas of 240mL water.~Intake of 2 tablets of Motilium\u00ae (API: loperamide HCl 2 mg) 20 minutes before the intake of Gabbroral\u00ae oral tablet formulation, which will be dissolved in a glas of 240mL water.~Conduct of the study~The study consists of four testing days in the University Hospitals Leuven, Gasthuisberg campus.~On each test day you come at the agreed time in fasting State to the Gastroenterology Department at UZ Leuven (Gasthuisberg, floor 0, Orange arrow). Fasted state means that you have eaten nothing for 12 hours for the investigation and only have been drinking water.~A basic clinical anamnesis will be taken by a doctor to make sure that you are a healthy volunteer for our study. For making sure that you are HIV negative, you will undergo an HIV test. In case of a female volunteer, a pregnancy test will be taken in account to make sure you are not pregnant.~Upon arrival at the hospital through the nose or the mouth two probes: one in the stomach and one in the gut. The position of both probes is controlled using fluoroscopy (x-ray).~After a stabilisation period of ca. 20 min you will be asked for taking a single dose of Gabbroral\u00ae oral tablet formulation. On four different test days, with an intermediate period of at least 7 days, we will follow every one of following intake conditions:~intake of Gabbroral\u00ae oral tablet formulation, which will be dissolved in a glas of 240mL water, in fasted state.~intake of Gabbroral\u00ae oral tablet formulation in fed state.~Intake of 2 tablets of Motilium\u00ae (API: domperidone 10 mg) 20 minutes before the intake of Gabbroral\u00ae oral tablet formulation, which will be dissolved in a glas of 240mL water.~Intake of 2 tablets of Motilium\u00ae (API: loperamide HCl 2 mg) 20 minutes before the intake of Gabbroral\u00ae oral tablet formulation, which will be dissolved in a glas of 240mL water.~After intake of the medicine at regular intervals, gastrointestinal fluids will be aspirated over 4 hours. You sit in a comfortable position in bed; eating and sleeping is not permitted (after 2 hours you have the possibility to drink some water).~After 4 hours, the gastrointestinal catheters will be removed and you may eat and roam freely.", - "NCTID": "NCT01780909" - }, - { - "brief_title": "SBI in Children With d-IBS", - "phase": "", - "drugs": "['Medical Food', 'Placebo']", - "drugs_list": [ - "Medical Food", - "Placebo" - ], - "diseases": "['Irritable Bowel Syndrome']", - "diseases_list": [ - "Irritable Bowel Syndrome" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Males and non-pregnant females between 8 years and 18 years at the time of consent. \n\n Able to obtain parental or legal guardian informed consent from subjects as applicable. \n\n d-IBS determined by ROME III criteria. A Rome III diagnosis consists of recurrent abdominal pain or discomfort at least 2days/week in the last 3 months prior to enrollment associated with two or more of the following10: \n\n 1. Improvement with defecation 2. Onset associated with a change in frequency of stool 3. Onset associated with a change in form (appearance) of stool. \n\n ", - "exclusion_criteria": ": \n\n Children taking pharmacologic treatment for d-IBS will be excluded. \n\n Children who are unable to articulate symptoms of IBS will be excluded. \n\n Non-English speaking children will be excluded. \n\n Children with known allergy or hypersensitivity to beef or any component of SBI. \n\n Pregnancy.", - "brief_summary": "IBS is the most common diagnosis in new patients in our pediatric gastroenterology clinic, accounting for 36 % of all new patients. Pediatric IBS patients always have a problem with defecation, characterized either as diarrhea predominant or constipation predominant. About one third of pediatric IBS subjects have d-IBS. There are no FDA approved treatments for children with d-IBS. There is evidence that diarrhea predominant irritable bowel syndrome d-IBS may be caused by a mild inflammation in the intestinal lining. Oral serum-derived bovine immunoglobulin protein isolate (SBI) is a medical food, believed to treat mild inflammation in the small intestine associated with some cases of d-IBS, especially those arising after acute gastroenteritis. It improved pain and diarrhea in adults with d-IBS. Our aim is to determine if SBI improves the number of spontaneous bowel movements in children with d-IBS.", - "NCTID": "NCT02609529" - }, - { - "brief_title": "Normative State and Variation in Growth, Hematology, Hydration, Oxidation, Infection, Inflammation, Guatemalan Children", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "91.0", - "inclusion_criteria": "inclusion criteria: \n\n To be attending one of the SOSEP systems assigned daycare centers \n\n To maintain an attendance of 80% during the 8 weeks of the fieldwork \n\n Aged 23 to 84 months \n\n Being apparently healthy and with no dietary restrictions related to the foods offered with the SOSEP menu. \n\n ", - "exclusion_criteria": ": \n\n Children whose parents of caregivers did not sign a consent form \n\n Children who refused to participate in the study \n\n Children who refused to adhere to the collections routines.", - "brief_summary": "This study will provide the researchers with an opportunity for the investigation of the biomarkers and different human biology component variable interactions in children; information that can generate new correlations between markers not known at the moment.~Regarding their analysis, variation could have multiple connotations. A categorical that refers to a specific state, established with a diagnostic standard. And a numerical, referring to a range or the absolute value limits in a continuous spectrum; this research will allow us to express variability in the distance amplitude of the obtained values level, as well as classifications or categories previously established in the possible cases.~OBJECTIVES PRINCIPAL OBJECTIVE~To estimate the inter and intra-individual variety in a selected series or biological variables determinant of growth, body composition, infection, oxidation, inflammation and hydration, in preschool children sharing the same institutional-based diet.~SPECIFIC OBJECTIVES~To determine the inter and intra-individual variation of growth in preschool children, with a similar diet, who attend Secretariat of Beneficial Works of the First Lady system daycare centers and to compare between semi-urban and rural.~To describe the inter-individual variation of the red blood cells circulating mass in preschool children, with a similar diet, who attend day care centers and to compare between semi-urban and rural.~To determine the inter-individual variation of systemic and intraintestinal oxidation in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural.~To describe the inter-individual variation of systemic and intraintestinal inflammation in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural.~To determine the inter and/or intra-individual variation of urinary tract infection and gastrointestinal parasite infestation in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural.~To describe the inter and intra-individual variation of the hydration status in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural.~To explore intra-individual associations in variables of the same research component or different component variables.", - "NCTID": "NCT02203890" - }, - { - "brief_title": "The Effect of an Urban Sanitation Intervention on Child Health", - "phase": "", - "drugs": "['Sanitation']", - "drugs_list": [ - "Sanitation" - ], - "diseases": "['Diarrhea', 'Helminthiasis']", - "diseases_list": [ - "Diarrhea", - "Helminthiasis" - ], - "enrollment": "1866.0", - "inclusion_criteria": "inclusion criteria: \n\n Children normally resident in households with access to new shared sanitation (the intervention) as selected by implementing organisation (WSUP) or control children normally resident in households sharing existing shared sanitation within geographically delimited project bounds and meeting WSUP site selection criteria (including number of people served) \n\n ", - "exclusion_criteria": ": \n\n Refusal to participate", - "brief_summary": "The purpose of this study is to determine the health impact of a basic sanitation intervention in Maputo, Mozambique.", - "NCTID": "NCT02362932" - }, - { - "brief_title": "Lao Zinc Study: Effects of Two Forms of Daily Preventive Zinc Versus Therapeutic Zinc Supplementation", - "phase": "", - "drugs": "['MNP', 'preventive zinc supplement', 'therapeutic zinc supplement', 'preventive placebo supplement', 'therapeutic placebo supplement', 'placebo powder']", - "drugs_list": [ - "MNP", - "preventive zinc supplement", - "therapeutic zinc supplement", - "preventive placebo supplement", - "therapeutic placebo supplement", - "placebo powder" - ], - "diseases": "['Diarrhea']", - "diseases_list": [ - "Diarrhea" - ], - "enrollment": "3433.0", - "inclusion_criteria": "inclusion criteria: \n\n Signed informed consent from at least one parent or primary caregiver \n\n Age 6-23 months initially \n\n Permanent resident of study area \n\n Planned availability during the period of the study \n\n Acceptance of home visitors \n\n ", - "exclusion_criteria": ": \n\n Weight-for-height z-score (WHZ) <-3Z with respect to WHO 2006 standards \n\n Presence of bipedal edema \n\n Severe illness warranting hospital referral \n\n Congenital abnormalities potentially interfering with growth \n\n Chronic medical condition (e.g. malignancy) requiring frequent medical attention \n\n Known HIV infection of index child or child's mother \n\n Hemoglobin <70 g/L \n\n Currently consuming zinc supplements \n\n Current participation in any other clinical trial", - "brief_summary": "The study will be conducted as a community-based, randomized, placebo-controlled, trial with four study groups. The overall objective of the study is to determine the optimal method for delivering zinc to young children, both for the prevention of zinc deficiency and treatment of diarrhea. In particular, the investigators plan to compare the impact on physical growth, morbidity, micronutrient status, immune function, environmental enteric dysfunction, parasite burden and hair cortisol concentration of: 1) daily preventive zinc supplementation as a micronutrient powder (MNP); 2) placebo powders; 3) daily preventive zinc supplementation as dispersible tablets; 4) therapeutic zinc supplementation as dispersible tablets given in relation to episodes of diarrhea.~In addition to the major outcomes mentioned above, the investigators will monitor adherence to the interventions, neuro-behavioral development, and the occurrence of any adverse events.", - "NCTID": "NCT02428647" - }, - { - "brief_title": "Study of Alternative Vaccination Schedule of Oral Cholera Vaccine", - "phase": "Phase 2", - "drugs": "['Modified killed oral cholera vaccine at 14 day interval', 'Modified killed oral cholera vaccine at 28 day interval']", - "drugs_list": [ - "Modified killed oral cholera vaccine at 14 day interval", - "Modified killed oral cholera vaccine at 28 day interval" - ], - "diseases": "['Cholera', 'Diarrhoea', 'Vibrio Infection']", - "diseases_list": [ - "Cholera", - "Diarrhoea", - "Vibrio Infection" - ], - "enrollment": "386.0", - "inclusion_criteria": "Healthy, non-pregnant adults aged 18 years and above and healthy children aged 1 - 17 will be recruited in Kolkata. \n\n inclusion criteria: \n\n Males or non-pregnant females aged 18 years and above and children aged 1 -17 years who the investigator believes will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection). \n\n Written informed consent obtained from the subjects or their parents/guardians, and written assent for children aged 12 - 17 years. \n\n Healthy subjects as determined by: \n\n Medical history \n\n Physical examination \n\n Clinical judgment of the investigator \n\n ", - "exclusion_criteria": ": \n\n Ongoing serious chronic disease \n\n For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening) \n\n Immunocompromising condition or therapy (for corticosteroids this would mean \u22650.5 mg/kg/day) \n\n Diarrhea (3 or more loose/watery stools within a 24-hour period) 6 weeks prior to enrollment \n\n One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months \n\n One or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months \n\n Intake of any anti-diarrhea medicine in the past week \n\n Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours \n\n Acute disease one week prior to enrollment, with or without fever. Temperature \u226538\u00baC warrants deferral of the vaccination pending recovery of the subject \n\n Receipt of immunoglobulin or any blood product during the past 3 months \n\n Receipt of antibiotics in past 14 days \n\n Receipt of live or killed enteric vaccine in past 4 weeks \n\n Receipt of killed oral cholera vaccine", - "brief_summary": "The absence of a boosting response after a 14 day interval with the two-dose regimen of the modified killed oral cholera vaccine raises the possibility that a longer dosing interval may be required to observe a boost in the immune response. This study will compare the immune responses following 14-day and 28-day dosing intervals.", - "NCTID": "NCT01233362" - }, - { - "brief_title": "MAgnetic Resonance Imaging in COeliac Disease", - "phase": "", - "drugs": "['Gluten free diet']", - "drugs_list": [ - "Gluten free diet" - ], - "diseases": "['Celiac Disease', 'Coeliac Disease', 'Celiac Sprue', 'Gluten Enteropathy']", - "diseases_list": [ - "Celiac Disease", - "Coeliac Disease", - "Celiac Sprue", - "Gluten Enteropathy" - ], - "enrollment": "72.0", - "inclusion_criteria": "Inclusion: \n\n Patients newly diagnosed with coeliac disease: \n\n Male or female \n\n Able to give informed consent \n\n Able to schedule the first MRI scan (Visit 2 of the study) within a month of having had a duodenal biopsy and not yet commenced on a gluten free diet. \n\n Inclusion \n\n Pilot study in healthy volunteers: \n\n Healthy volunteers (without any comorbidities) \n\n Able to give informed consent \n\n Exclusion Pilot study in patients \n\n Any past serious, unstable medical condition, unstable/uncontrolled diabetes mellitus, major psychiatric diagnosis \n\n Any reported history of gastrointestinal surgery that could affect gastrointestinal function (colectomy, small bowel resection) \n\n Pregnancy declared by candidate \n\n Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury \n\n Reported alcohol dependence \n\n Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists during or in the 2 weeks prior to the test. The following medications can be permitted during the course of the study, as long as they have been used at a constant dosage and were commenced at least 1 month prior to the start of the study: birth control pill, or depot intramuscular contraceptive preparation, oestrogen-progesterone replacement therapy, L-thyroxine, lowdose antidepressants (up to 25 mg day) of amitriptyline, nortriptyline, or selective serotonin reuptake inhibitor), or antihypertensive in the diuretic, angiotensin converting enzyme inhibitor or angiotensin II inhibitor classes. Antibiotic or probiotic treatment in the past 4 weeks \n\n Inability to lie flat or exceed scanner limits of weight <120kg \n\n Poor understanding of English language \n\n Participation of any medical trials for the past 3 months \n\n Judgement by the PI that the candidate who will be unable to comply with the full study protocol e.g. severe COPD \n\n Noncompliance to gluten free diet after first, untreated MRI. \n\n Exclusion \n\n Healthy volunteers: \n\n Serology positive test for coeliac disease markers \n\n Any reported history of gastrointestinal surgery that could affect gastrointestinal function (colectomy, small bowel resection) \n\n Presence of an intestinal stoma \n\n Pregnancy declared by candidate \n\n Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury \n\n Reported alcohol dependence \n\n Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists during or in the 2 weeks prior to the test. The following medications can be permitted during the course of the study, as long as they have been used at a constant dosage and were commenced at least 1 month prior to the start of the study: birth control pill, or depot intramuscular contraceptive preparation, oestrogen-progesterone replacement therapy, L-thyroxine, lowdose antidepressants (up to 25 mg day1 of amitriptyline, nortriptyline, or selective serotonin reuptake inhibitor), or antihypertensive in the diuretic, angiotensin converting enzyme inhibitor or angiotensin II inhibitor classes. \n\n Proton Pump Inhibitor (PPI), antibiotic or probiotic treatment in the past 12 weeks \n\n Inability to lie flat or exceed scanner limits of weight <120kg \n\n Poor understanding of English language \n\n Participation of any medical trials for the past 3 months", - "exclusion_criteria": "", - "brief_summary": "One in 100 people suffers from coeliac disease. It affects the lining of the bowel and causes many symptoms such as diarrhoea, wind, stomach pain, constipation and nausea. The only treatment so far is a strict glutenfree diet for life which reverses the bowel damage and often improves symptoms. Up to 25% of patients however may have persistent symptoms despite the gluten free diet but the reasons for this are not clear.~This research aims to help us understand how the gluten free diet works. Investigators will use medical imaging (magnetic resonance imaging or MRI) to measure the volumes of fluid in the small bowel, the size of the large bowel and the time it takes for foods to go through the entire bowel in patients who have just been diagnosed with coeliac disease by their hospital doctor. Investigators will also carry out a breath test and collect a stool sample for basic analysis of the stool bacteria.~Investigators will also collect questionnaires about their feelings and their bowel habits and will try to see how the MRI measurements relate to the patients' symptoms. Investigators will observe how all these measures change after one year of the gluten free diet that doctors will have prescribed as part of the coeliac patients' standard care. As such there is no dietary intervention in this study, investigators will simply study changes in the patients due to their standard treatment. Investigators will also look at a matched group of healthy volunteers to gather a likely reference range of the measurements. This research will be carried out in Nottingham with the help of the specialist coeliac clinics and it will last 3 years. There is a dedicated Coeliac Patient Public Involvement group who have helped plan this study.", - "NCTID": "NCT02551289" - }, - { - "brief_title": "Acute Gastrointestinal Tolerability Following a Single Serving of a Novel Dietary Fiber", - "phase": "", - "drugs": "['Novel Fiber', 'Positive Fiber control', 'Negative Control']", - "drugs_list": [ - "Novel Fiber", - "Positive Fiber control", - "Negative Control" - ], - "diseases": "['Signs and Symptoms, Digestive']", - "diseases_list": [ - "Signs and Symptoms", - "Digestive" - ], - "enrollment": "45.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject is male or female, 18-54 years of age, inclusive. \n\n Subject has a body mass index (BMI) \u226518.50 and \u226439.99 kg/m2 at visit 1 (day -7) and has been weight stable (\u00b1 4.5 kg) for the previous 3 months. \n\n Subject is judged to be in good health on the basis of medical history. \n\n Subject is willing to maintain his or her habitual diet and physical activity patterns, including habitual use of study approved medications and/or dietary supplements throughout the study period. \n\n Subject is willing to avoid foods/beverages that cause GI-distress, as well as high-fiber foods for 24 h prior to, and following, visits 2, 4, 6, 8, and 10. \n\n Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators. \n\n ", - "exclusion_criteria": ": \n\n Subject reports any clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, history of surgery for weight loss, gastroparesis, and clinically important lactose intolerance). \n\n History or presence of clinically important endocrine (including type 1 or 2 diabetes mellitus), cardiovascular, pulmonary, biliary, renal, hepatic, pancreatic, or neurologic disorders that, in the opinion of the Investigator, could interfere with the interpretation of the study results. \n\n Recent history (within 6 weeks of screening, visit 1) of constipation (defined as <3 bowel movements per week), and/or diarrhea (defined as \u22653 loose or liquid stools/d). \n\n Recent (within 6 weeks of screening, visit 1) episode of acute GI illness such as nausea, vomiting or diarrhea. \n\n Daily use of non-steroidal anti-inflammatory drugs (NSAIDS). \n\n Daily use of antacids, proton pump inhibitors, H2 blockers. \n\n Recent use of antibiotics (within 3 months of visit 2, day 0). \n\n Use of medications (over-the-counter and prescription) or dietary supplements (within 3 weeks of visit 2, day 0) known to influence GI function such as constipation medications and supplements (including laxatives, enemas, fiber supplements and/or suppositories); anti-diarrheal agents; anti-spasmodic; prebiotic and probiotic supplements. \n\n Extreme dietary habits, including but not limited to vegetarian diets and intentional consumption of a high fiber diet. \n\n Known allergy or sensitivity to food ingredients such as: soy, dairy (milk), wheat, egg, peanuts, tree nuts, fin fish and crustacean. \n\n Uncontrolled hypertension (systolic blood pressure \u2265160 mm Hg or diastolic blood pressure \u2265100 mm Hg at visit 1, day -7). One re-test will be allowed on a separate day prior to visit 2 (day 0), for subjects whose blood pressure exceeds either of these cut points at visit 1, in the judgment of the Investigator. \n\n History of cancer in the prior two years, except for non-melanoma skin cancer. \n\n Any major trauma or surgical event within 2 months of visit 2, day 0. \n\n Females who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are unwilling to commit to use of a medically approved form of contraception throughout the study period. The method of birth control must be recorded in the source documentation. \n\n Exposure to any non-registered drug product within 30 days prior to the screening visit. \n\n Recent history of (within 12 months of visit 1) or strong potential for alcohol or substance abuse. Alcohol abuse defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1\u00bd oz distilled spirits). \n\n Recent history of (within 2 months of visit 1) use of any tobacco-containing products. \n\n Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or confound the interpretation of the study results or put the subject at undue risk.", - "brief_summary": "The study will assess the gastrointestinal tolerability of a single serving of a novel dietary fiber at three different dose levels in generally healthy men and women. Double-blind controlled, cross-over clinical trial with negative (no added fiber) and positive controls. Single dose, with 24 hours data collection and 1 week wash-out between cross-overs. 45 randomized, generally healthy men and women, 18-54 y, BMI higher or equal to 18.5 and smaller or equal to 39.99 kg/m2. Novel dietary fiber ingredient and positive control will be delivered in 240 ml beverages.", - "NCTID": "NCT02530762" - }, - { - "brief_title": "WASH Benefits Kenya", - "phase": "", - "drugs": "['Water Quality', 'Sanitation', 'Handwashing', 'Nutrition']", - "drugs_list": [ - "Water Quality", - "Sanitation", - "Handwashing", - "Nutrition" - ], - "diseases": "['Malnutrition', 'Diarrhea', 'Child Development']", - "diseases_list": [ - "Malnutrition", - "Diarrhea", - "Child Development" - ], - "enrollment": "8246.0", - "inclusion_criteria": "Study Population Description: \n\n The subject population will be young children and their mothers/guardians living in several contiguous districts of Western Province, in the rural areas outside the towns of Bungoma and Kakamega. Communities must meet the following criteria: \n\n Located in a rural area (defined as villages with <25% residents living in rental houses, <2 gas/petrol stations and <10 shops) \n\n Not enrolled in ongoing WASH or nutrition programs \n\n No chlorine dispensers at water sources installed by programs separate from the present study \n\n Majority (>80%) of households do not have access to piped water into the home \n\n At least six eligible pregnant women in the cluster at baseline. \n\n From enrolled communities, household compounds will be enrolled if they meet the following criteria. \n\n inclusion criteria: \n\n One or more women who self-identify as pregnant at the time of the baseline survey \n\n The woman plans to stay in the community for the next 12 months. \n\n ", - "exclusion_criteria": ": \n\n (1) The study excludes households who do not own their home to help mitigate attrition during follow-up.", - "brief_summary": "The purpose of this study is to measure the independent and combined effects of interventions that improve sanitation, water quality, handwashing, and nutrition on child health and development in the first years of life.", - "NCTID": "NCT01704105" - }, - { - "brief_title": "A Study of the Safety and Efficacy of Infliximab (Remicade) in Pediatric Patients With Crohn's Disease", - "phase": "Phase 3", - "drugs": "['infliximab']", - "drugs_list": [ - "infliximab" - ], - "diseases": "['Crohn Disease']", - "diseases_list": [ - "Crohn Disease" - ], - "enrollment": "112.0", - "inclusion_criteria": "inclusion criteria: \n\n Between the ages of 6 and 17 years \n\n Have had Crohn's disease diagnosed for at least 3 months prior to screening, with gastritis, duodenitis, colitis, ileitis, or ileocolitis, previously confirmed by endoscopy and biopsy \n\n Have active Crohn's disease despite adequate current treatment with an immunomodulator (ie, AZA, 6-MP, or MTX). \n\n ", - "exclusion_criteria": ": \n\n Disease complications for which surgery might be indicated \n\n Surgery for bowel diversion with placement of a stoma within 3 months prior to screening \n\n Positive stool examination for enteric pathogens including Giardia lamblia, Clostridium difficile, Shigella species, and Salmonella species.", - "brief_summary": "A study of the safety and efficacy of infliximab (Remicade) in pediatric patients with moderate to severe Crohn's Disease", - "NCTID": "NCT00207675" - }, - { - "brief_title": "Safety and Immunogenicity of Peru-15 Vaccine When Given With Measles Vaccine in Healthy Indian and Bangladeshi Infants", - "phase": "Phase 2", - "drugs": "['Peru-15 Vaccine', 'Placebo']", - "drugs_list": [ - "Peru-15 Vaccine", - "Placebo" - ], - "diseases": "['Cholera', 'Diarrhea', 'Vibrio Infections']", - "diseases_list": [ - "Cholera", - "Diarrhea", - "Vibrio Infections" - ], - "enrollment": "74.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy male and female infants aged 9 - 12 months will be recruited from Vellore, India and Dhaka, Bangladesh. \n\n All subjects must satisfy the following criteria at study entry: \n\n Male or female infants aged 9 - 12 months whose parents or primary caretaker have given the written informed consent prior to study entry \n\n Will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection). \n\n Healthy subjects as determined by: \n\n Medical history \n\n Physical examination \n\n Clinical judgment of the investigator \n\n ", - "exclusion_criteria": ": \n\n Parents or primary caregiver are unwilling or unable to give written informed consent to participate in the study \n\n Ongoing serious chronic disease \n\n Immunocompromising condition or therapy \n\n Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours \n\n Intake of any anti-diarrheal medicine in the past week \n\n Acute disease one week prior to enrollment, with or without fever. Temperature \u226538\u00baC (oral) or axillary temperature \u2265 37.5\u00baC warrants deferral of the vaccination pending recovery of the subject \n\n Receipt of antibiotics in the past 2 weeks \n\n Receipt of live or killed enteric vaccine in the last 4 weeks \n\n Diarrhea (3 or more loose stools within a 24-hour period) 6 weeks prior to enrollment \n\n One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months \n\n One or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months \n\n Receipt of killed oral cholera vaccine \n\n Have previously received a dose of a measles-containing vaccine (MCV) \n\n Have previously presented with a disease potentially related to measles \n\n Receipt of blood, blood products or a parenteral immunoglobulin preparation in the previous 3 months \n\n History of anaphylaxis, any serious vaccine reaction, allergy to eggs, egg products or to any measles vaccine component \n\n any condition which in the opinion of the investigator, might interfere with the evaluation of the study objectives", - "brief_summary": "The purpose of this study is to confirm the safety and immunogenicity of Peru-15 vaccine in infants when given simultaneously with measles vaccine.", - "NCTID": "NCT00624975" - }, - { - "brief_title": "Dose-Finding Study of CS19 Expressing ETEC Challenge Strains", - "phase": "Phase 1", - "drugs": "['CS19 expressing ETEC strain']", - "drugs_list": [ - "CS19 expressing ETEC strain" - ], - "diseases": "[\"Travelers' Diarrhea\"]", - "diseases_list": [ - "Travelers' Diarrhea" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female between 18 and 45 years of age, inclusive. \n\n General good health, without significant medical illness, abnormal physical examination findings or clinical laboratory abnormalities as determined by principal investigator (PI) or PI in consultation with the medical monitor and Sponsor. \n\n Demonstrate comprehension of the protocol procedures and knowledge of ETEC illness by passing a written examination (pass grade \u2265 70%) \n\n Willing to participate after informed consent obtained. \n\n Available for entire inpatient portion of study and all outpatient study visits. \n\n Negative serum pregnancy test at screening (initial visit and day -7 to - 3) and a negative urine pregnancy test on the day of admission to the inpatient phase for female subjects of childbearing potential. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Alternatively, abstinence alone is acceptable. Female subjects who are unable to bear children must provide supporting documentation (e.g., prior tubal ligation or hysterectomy). \n\n ", - "exclusion_criteria": ": \n\n Presence of a significant medical condition, (e.g., psychiatric conditions or gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis or gastroesophageal reflux disease, inflammatory bowel disease, alcohol or illicit drug abuse/dependency), or other laboratory abnormalities which in the opinion of the investigator precludes participation in the study. \n\n Immunosuppressive illness or IgA deficiency (below the normal limits) \n\n Positive serology results for HIV, HBsAg, or HCV antibodies. \n\n Significant abnormalities in screening laboratory hematology, serum chemistry, urinalysis, as determined by PI or PI in consultation with the medical monitor and Sponsor. \n\n Allergy to fluoroquinolones, cotrimoxazole, or ampicillin/penicillin (excluded if allergic to two of three). \n\n Fewer than 3 stools per week or more than 3 stools per day as the usual frequency; loose or liquid stools other than on an occasional basis. \n\n History of diarrhea in the 2 weeks prior to planned inpatient phase. \n\n Regular use of laxatives or any agent that increases gastric pH (regular defined as at least weekly). \n\n Use of antibiotics during the 7 days before bacterial dosing or proton pump inhibitors, H2 blockers, or antacids within 48 hours of dosing. \n\n Travel to countries where ETEC or cholera infection is endemic (most of the developing world) within two years prior to dosing. \n\n History of vaccination for or ingestion of ETEC, cholera, or LT toxin. \n\n Stool culture (collected no more than 1 week prior to admission) positive for ETEC or other bacterial enteric pathogens (Salmonella, Shigella and Campylobacter). \n\n Use of any investigational product within 30 days preceding the receipt of the challenge inoculum, or planned use during the active study period. \n\n Use of any medication known to affect the immune function (e.g., corticosteroids) within 30 days preceding receipt of the challenge inoculum or planned use during the active study period. (Topical and intra-articular steroids will not exclude subjects). MANAGEMENT", - "brief_summary": "This will be a strain and dose-finding study in which CS19-ETEC strain WS0115A will be administered at a starting inoculum of 5 x 108 colony forming units (cfu) to 5 subjects as the initial step to establish a human disease model. If an 80% attack rate (AR) for predefined diarrheal disease is achieved without high output diarrhea, the same inoculum will be given to 5 - 10 more subjects for confirmation of AR. If an 80% AR is not achieved, AR and severity of disease will be evaluated to determine if the dose should be increased. The same sequence may be conducted with DS26-1 as necessary. If the WS0115A strain causes high output diarrhea, the dose will be adjusted down and further dose characterization continued. An iterative process will be used to select the optimal strain and dose with each step reviewed and approved by the medical monitor.", - "NCTID": "NCT00564863" - }, - { - "brief_title": "Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis for Ivory Coast (DOLF-Ivory Coast)", - "phase": "", - "drugs": "['Annual versus Semiannual Albendazole plus Ivermectin MDA']", - "drugs_list": [ - "Annual versus Semiannual Albendazole plus Ivermectin MDA" - ], - "diseases": "['Lymphatic Filariasis', 'Onchocerciasis', 'Soil Transmitted Helminth (STH) Infections']", - "diseases_list": [ - "Lymphatic Filariasis", - "Onchocerciasis", - "Soil Transmitted Helminth (STH) Infections" - ], - "enrollment": "14457.0", - "inclusion_criteria": "inclusion criteria: \n\n Study areas should be endemic for filariasis and onchocerciasis. \n\n Study population have limited or no prior experience with MDA. Males and Females greater than or equal to 5 years of age. \n\n ", - "exclusion_criteria": ": \n\n Children less than 5 years of age. \n\n Children who weigh less than 15 kg (33 lb)", - "brief_summary": "Approximately 4,000 people will participate per year. The study population will include females and males over 5 years of age who live in filariasis and onchocerciasis endemic areas. Subject selection will not be based on health status.~Two sites will be studied, and each study will last for 4 years. Participants will be studied only once in cross-sectional surveys. Some subjects may be included in more than one annual population survey, but this is not a longitudinal study.~Investigators will compare annual and semiannual mass drug administration (MDA) for lymphatic filariasis and onchocerciasis, and investigators will compare the impact of these MDA schedules on soil transmitted helminth infections. MDA will be administered by others (Ivorian Ministry of Health).~The investigators will test the hypothesis that semiannual mass drug administration (MDA) is superior to annual MDA for elimination of lymphatic filariasis, onchocerciasis and for control of soil transmitted helminth (STH) infections.~Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of lymphatic filariasis (LF) in these populations.~Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of onchocerciasis in these populations.~Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH) infection in these populations.", - "NCTID": "NCT02032043" - }, - { - "brief_title": "Comparative Efficacy of Ovule vs Tablet", - "phase": "Phase 3", - "drugs": "['Clotrimazole, vaginal ovule', 'Clotrimazole, vaginal tablet']", - "drugs_list": [ - "Clotrimazole", - "vaginal ovule", - "Clotrimazole", - "vaginal tablet" - ], - "diseases": "['Clotrimazole', 'Ovulen', 'Vulvovaginal Candidiasis']", - "diseases_list": [ - "Clotrimazole", - "Ovulen", - "Vulvovaginal Candidiasis" - ], - "enrollment": "466.0", - "inclusion_criteria": "inclusion criteria: \n\n Non-pregnant females aged at least 14 years in Germany or at least 16 years in Russia and not older than 50 years. \n\n Subjects presenting a symptomatic vulvovaginal yeast infection confirmed by microscopic evaluation (wet mount preparation). \n\n Subjects must be cooperative, able to understand the requirements of the trial participation, and willing to participate in the trial. For adolescents the informed consent has to be provided to a legal representative in addition. \n\n Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception. \n\n Negative saline smear for Trichomonas vaginalis \n\n ", - "exclusion_criteria": ": \n\n Subjects with known hypersensitivity to imidazoles or triazoles and their analogues. \n\n Subjects presenting a protozoan infection as confirmed by microscopic investigation. \n\n Pregnant, breast feeding or lactating subjects. \n\n Subjects with suspected bacterial vaginal infection. \n\n Subjects with abdominal pain, fever, or foul smelling vaginal discharge. \n\n Subjects who had a vaginal infection, or who had used an intravaginal or systemic antimycotic treatment within 60 days prior to visit 1. \n\n Subjects using or wishing to use intra-vaginal or systemic anti-infectives or systemic antifungal therapy during the trial. \n\n Subjects wishing to use contraceptive foams, creams, jellies, sponges, therapeutic ointments, condoms, diaphragms, and OTC vaginal products during treatment and 3 days thereafter (i.e. until day 4). \n\n Subjects unable to refrain from the use of vaginal tampons during treatment and for 3 days thereafter (i.e. until day 4). \n\n Subjects unable to refrain from the use of feminine hygiene products (e.g. douches, feminine deodorant products) for 2 weeks (i.e. from visit 1 until visit 2). \n\n Subjects suffering from chronic/recurrent vulvovaginal mycosis, defined as 4 or more mycologically proven symptomatic episodes during the last 12 months. \n\n Subjects suffering from diseases (e.g. diabetes, decreased cellular immunity) or being treated with drugs (e.g. immunosuppressants, corticosteroids, anti-infectives) which may predispose them to mycological infections. \n\n Subjects who received another investigational drug within 30 days before visit 1. \n\n Unwillingness to refrain from sexual activity during 3 days thereafter. \n\n Actual menstruation at visit 1 or expected menstruation within 4 days after visit 1.", - "brief_summary": "The study is focused to prove that the efficacy of a new Canesten formulation (ovule) is not inferior to the old Canesten formulation (tablet)", - "NCTID": "NCT00755053" - }, - { - "brief_title": "Dietary Fiber for Fecal Incontinence", - "phase": "", - "drugs": "['Psyllium', 'Gum Arabic', 'carboxymethylcellulose', 'Placebo']", - "drugs_list": [ - "Psyllium", - "Gum Arabic", - "carboxymethylcellulose", - "Placebo" - ], - "diseases": "['Fecal Incontinence']", - "diseases_list": [ - "Fecal Incontinence" - ], - "enrollment": "206.0", - "inclusion_criteria": "inclusion criteria: \n\n age \u226518 years \n\n living in the community (not a nursing home or assisted living facility) \n\n self-report of usually having FI of loose or liquid consistency at least twice in a 2-wk period \n\n toilets independently \n\n ability to read and write in English. \n\n Persons that regularly performed pelvic floor muscle exercises and/or biofeedback on a maintenance regimen for at least 20 wks or who took a steady dose of anti-motility medications on a regular schedule that still met the FI criteria were also eligible. \n\n ", - "exclusion_criteria": ": \n\n difficulty swallowing, \n\n a gastrointestinal (GI) tract altered by surgery, \n\n a malabsorption disorder, \n\n inflammatory bowel disease, \n\n gastrointestinal cancer or active cancer treatment, \n\n allergy to the fibers, \n\n regularly used a laxative or enema, were tube-fed, or unwilling to discontinue taking periodic self-prescribed fiber supplements or anti-diarrheal medications. \n\n a score \u226424 on the Mini Mental State Examination \n\n having/reporting fewer than two episodes of FI or being incapable of performing study procedures during the run-in baseline period", - "brief_summary": "The primary aim of this study was to compare the effects of supplementation with one of three dietary fibers (gum arabic, carboxy-methylcellulose, or psyllium) or a placebo on fecal incontinence (FI), symptom intolerance, and quality of life in community-living individuals who have incontinence of loose or liquid feces. A secondary aim was to explore the possible mechanism(s) underlying the supplements' efficacy (i.e., improvements in stool consistency, water-holding capacity or gel formation).", - "NCTID": "NCT01738607" - }, - { - "brief_title": "240 mL Water Drink Study", - "phase": "", - "drugs": "['Spring water']", - "drugs_list": [ - "Spring water" - ], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria: \n\n Apparently healthy; no medical conditions that might affect the study measurements \n\n Male or female \n\n Age between 18 and 55 years of age \n\n Body mass index (BMI) between 18.5 and 24.9 kg m-2 \n\n Suitable for MRI scanning (eg absence of metal implants, infusion pumps and pacemakers as assessed by the MRI safety questionnaire \n\n ", - "exclusion_criteria": ": \n\n Previous gastrointestinal surgery (excluding cholecystectomy and appendectomy) \n\n Known gastrointestinal disease \n\n Smoking \n\n History of alcohol or drug abuse \n\n Taking medication that is likely to affect gastrointestinal function \n\n Participation in night shift work the week prior to the study day. (Night work is defined as working between midnight and 6 am) \n\n Strenuous exercise greater than 10 hours per week \n\n Consumption of more than 21 units of alcohol in a typical week", - "brief_summary": "The GI MRI Research group at the University of Nottingham has been developing new, non-invasive magnetic resonance imaging (MRI) techniques to image the gastrointestinal tract. The investigators now want to characterise; in collaboration with the College of Pharmacy at the University of Michigan, the fasting volumes of gastric and small bowel liquid and their time courses over 2 hours after drinking the FDA recommended 240 mL of water drink for oral solid dosage forms testing.", - "NCTID": "NCT01792453" - }, - { - "brief_title": "Mebendazole in Newly Diagnosed High-Grade Glioma Patients Receiving Temozolomide", - "phase": "Phase 1", - "drugs": "['Mebendazole']", - "drugs_list": [ - "Mebendazole" - ], - "diseases": "['Newly Diagnosed High-Grade Glioma']", - "diseases_list": [ - "Newly Diagnosed High-Grade Glioma" - ], - "enrollment": "24.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients must have histologically confirmed newly diagnosed high-grade glioma(WHO Grade III or IV) \n\n Age \u226518 years \n\n Karnofsky Performance Score (KPS) \u2265 60% \n\n Life expectancy greater than 12 weeks \n\n Patients must have adequate organ and marrow function \n\n Completed >80% of the prescribed radiation therapy and concurrent temozolomide according to the Stupp regimen without grade 3 or 4 hematologic toxicity \n\n Patients may have received Gliadel during surgery \n\n Ability to swallow pills and keep medication record \n\n women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation. \n\n Ability to understand and willingness to sign a written informed consent document \n\n Be able to comply with treatment plan, study procedures and follow-up examinations \n\n ", - "exclusion_criteria": ": \n\n Patients must not have received prior therapy other than standard chemoradiation according to Stupp et al and Gliadel. \n\n Patients may not be receiving any other investigational agents while on study \n\n Patients who have known allergy to mebendazole or benzimidazole \n\n Patients who have previously had a severe side effect, such as agranulocytosis and neutropenia, in conjunction with previous mebendazole or benzimidazole class drug for a parasitic infection \n\n Patients who are taking metronidazole and cannot be safely moved to a different antibiotic greater than 7 days prior to starting mebendazole therapy \n\n Patients who have taken any benzimidazole (ABZ, flubendazole, thiabendazole, fenbendazole, triclabendazole, etc.) within the last 3 months \n\n Patients who are taking any anti-convulsant medication that interferes with the cytochrome P450 pathway (e.g. phenytoin, phenobarbital, carbamazepine, etc.) \n\n Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, chronic hepatitis, acute hepatitis, or psychiatric illness/social situation that would limit compliance with study requirements \n\n Pregnant women are excluded \n\n Patients with human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C positive; or with a history of chronic active hepatitis or cirrhosis \n\n Patients with a history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product administration or may interfere with the interpretation of the results \n\n Patients who are not available for follow-up assessments or unable to comply with study requirements", - "brief_summary": "The purpose of this study is to find the highest dose of mebendazole (MBZ) that can be safely given to people with malignant brain tumors in combination with the current standard of care (temozolomide) without causing severe side effects. We also want to find out if MBZ can slow the growth of the brain tumor. The study doctors have found that MBZ is effective against malignant brain tumors in the laboratory and animal models of brain tumors.", - "NCTID": "NCT01729260" - }, - { - "brief_title": "A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency", - "phase": "Phase 3", - "drugs": "['Pancrease MT 10.5, or MT 21', 'Placebo for Pancrease MT 10.5 or MT 21']", - "drugs_list": [ - "Pancrease MT 10.5", - "or MT 21", - "Placebo for Pancrease MT 10.5 or MT 21" - ], - "diseases": "['Exocrine Pancreatic Insufficiency', 'Steatorrhea', 'Malabsorption Syndromes', 'Cystic Fibrosis']", - "diseases_list": [ - "Exocrine Pancreatic Insufficiency", - "Steatorrhea", - "Malabsorption Syndromes", - "Cystic Fibrosis" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Have a diagnosis of CF documented by sweat chloride results (>60 mmol/L) and require pancreatic enzyme replacement therapy (PERT) to control clinical symptoms of EPI (nausea, vomiting, bloating, diarrhea, and abdominal pain) with a history of excess fat in the feces \n\n Have documentation of an abnormal COA-fat and a fecal elastase result of <100 micrograms fecal elastase/gram stool \n\n Must be on a stable diet and dose of pancreatic enzyme supplementation that has provided satisfactory symptom control for at least the past 1 month \n\n ", - "exclusion_criteria": ": \n\n No extreme physical wasting with loss of weight and muscle mass \n\n No severe, acute, or chronic pulmonary disease unrelated to complications of CF \n\n No worsening of pulmonary disease in past 30 days \n\n No use of drugs known to affect blood uric acid concentrations (e.g., aspirin, diflunisal, allopurinol, probenecid, thiazide diuretics, phenylbutazone, sulfinpyrazone) \n\n No known congenital (present at birth) abnormalities of the gastrointestinal tract, heart, or liver \n\n No distal intestinal obstruction syndrome (DIOS)", - "brief_summary": "The purpose of this study is to assess the effectiveness and safety of oral pancrelipase MT in the treatment of adult and pediatric/adolescent cystic fibrosis (CF) patients with clinical symptoms of exocrine pancreatic insufficiency (EPI).", - "NCTID": "NCT00662675" - }, - { - "brief_title": "Evaluation of AN777 in Elderly Subjects", - "phase": "Phase 2; Phase 3", - "drugs": "['Ad lib diet and Control placebo', 'Ad lib diet and An 777', 'Ad lib diet/ placebo/ exercise', 'Ad lib diet; AN 777; exercise']", - "drugs_list": [ - "Ad lib diet and Control placebo", - "Ad lib diet and An 777", - "Ad lib diet/ placebo/ exercise", - "Ad lib diet; AN 777; exercise" - ], - "diseases": "['Aged']", - "diseases_list": [ - "Aged" - ], - "enrollment": "108.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject (male or female) is at least 65 years of age \n\n Subject has a Geriatric Nutritional Risk Index (GNRI)of 92 or over \n\n Subject has Body Mass Index (BMI) > 20.0 but <30.0 \n\n Subject is ambulatory \n\n Subject agrees to maintain current activity level \n\n ", - "exclusion_criteria": ": \n\n Subject has undergone major surgery, less than 4 weeks prior to enrollment in the study \n\n Subject has current active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix \n\n Subject has stated immunodeficiency disorder \n\n Subject has stated history of diabetes \n\n Subject has stated presence of partial or full artificial limb \n\n Subject has stated kidney disease \n\n Subject has stated history of uncontrollable hypertension \n\n Subject had myocardial infarction within the last 3 months \n\n Subject had recent antibiotic use (within 1 week prior to screening). \n\n Subject has a history of allergy to any of the ingredients in the study products \n\n Subject has an obstruction of the gastrointestinal tract precluding ingestion of the study product, inflammatory bowel disease, short bowel syndrome or other major gastrointestinal disease \n\n Subject has stated uncontrolled severe diarrhea, nausea or vomiting \n\n Subject has untreated clinically significant ascites, pleural effusion or edema \n\n Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder or any other psychological condition that may interfere with study product consumption \n\n Subject is actively pursuing weight loss \n\n Subject is currently taking medications/dietary supplements/substances that could profoundly modulate metabolism or weight Exceptions for multi-vitamin/mineral supplement, inhaled steroids for asthma or chronic obstructive pulmonary disease, topical or optical steroids and short-term use (less than two weeks) of dexamethasone", - "brief_summary": "To evaluate whether AN777 with or without exercise affects muscle mass change in elderly subjects.", - "NCTID": "NCT00798291" - }, - { - "brief_title": "Amoxicillin/Metronidazole Based Quadruple Therapy for Helicobacter Pylori Eradication", - "phase": "Phase 4", - "drugs": "['Lansoprazole', 'Bismuth Potassium Citrate', 'Amoxicillin', 'Metronidazole', 'Clarithromycin']", - "drugs_list": [ - "Lansoprazole", - "Bismuth Potassium Citrate", - "Amoxicillin", - "Metronidazole", - "Clarithromycin" - ], - "diseases": "['Dyspepsia', 'Peptic Ulcer']", - "diseases_list": [ - "Dyspepsia", - "Peptic Ulcer" - ], - "enrollment": "215.0", - "inclusion_criteria": "inclusion criteria: \n\n Participants with non-investigated/functional dyspepsia or scarred peptic ulcer with indication of H pylori eradication treatment \n\n Ability and willingness to participate in the study and to sign and give informed consent \n\n confirmed H pylori infection by at least one of the following methods: C13-urea breath test, histology, rapid urease test or bacterial culture. \n\n ", - "exclusion_criteria": ": \n\n patients with peptic ulcer \n\n previous H. pylori eradication therapy \n\n Age below 18 years \n\n major systemic diseases \n\n previous gastric surgery \n\n pregnancy or breastfeeding \n\n allergy to any of the study drugs \n\n receipt of anti-secretory therapy, antibiotics or bismuth salts 4 weeks prior to inclusion", - "brief_summary": "No trial has examined the the efficacy of amoxicillin and metronidazole based quadruple therapy for Helicobacter pylori treatment. The study aims to compare the effectiveness and safety of 14-day amoxicillin-/metronidazole-based quadruple regiment and classical quadruple regiment for Helicobacter pylori eradication.", - "NCTID": "NCT02175901" - }, - { - "brief_title": "Efficacy and Safety of Primovist in Chinese Patients", - "phase": "Phase 3", - "drugs": "['Gadoxetic Acid Disodium (Primovist, BAY86-4873)']", - "drugs_list": [ - "Gadoxetic Acid Disodium (Primovist", - "BAY86-4873)" - ], - "diseases": "['Known or Suspected Focal Liver Lesions']", - "diseases_list": [ - "Known or Suspected Focal Liver Lesions" - ], - "enrollment": "234.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients between 18 and 75 years of age inclusive. \n\n Patients (men or women) with at least one focal liver lesion, either identified or suspected by ultrasound (US), Computed Tomography (CT)/spiral-CT, conventional angiography, CT-angiography (CTA), CT-arterioportography (CTAP) or unenhanced / contrast-enhanced MRI* within 2 months before entering the study \n\n For reference, the following pathologies will meet the definition of 'focal liver lesions': \n\n Hepatocellular carcinoma \n\n Cholangiole carcinoma \n\n Metastasis \n\n Focal lymphoma \n\n Adenoma \n\n Focal nodular hyperplasia \n\n Hemangioma \n\n Abscess \n\n Focal liver fibrosis \n\n Regenerative nodules \n\n Focal fatty infiltration \n\n Hydatid cyst \n\n Liver cyst \n\n Focal sparing in fatty liver \n\n Others \n\n Patients willing to undergo study procedures including safety follow-up \n\n Patients who have undergone or who are scheduled to undergo the defined procedure for SOR within one month before or after the study MRI \n\n Women of child-bearing potential with negative urine pregnancy test result within 24 hours before contrast medium (CM) injection \n\n Patients who are fully informed about the study and have signed the informed consent form \n\n ", - "exclusion_criteria": ": \n\n Patients who have previously entered this study \n\n Patients who have received any contrast material within 24 hours before injection with study drug, or who are scheduled to receive any contrast material within 24 hours after injection \n\n Patients who are, or suspected to be, nursing \n\n Patients who require emergency treatment \n\n Patients with severely impaired hepatic or renal functions (e.g. serum glutamic-pyruvic transaminase (SGPT) twice the upper limit of reference range, acute renal failure) \n\n Patients who are clinically unstable and whose clinical course during the observation period is unpredictable (e.g. due to previous surgery, acute myocardial infarction) \n\n Patients with any physical or mental status that interferes with the signing of informed consent \n\n Patients with known anaphylactoid or anaphylactic reaction to any contrast media or hypersensitivity to any allergen including drugs \n\n Patients with a contraindication for MRI \n\n Patients who are scheduled for liver biopsy/surgery or other surgeries within 24 hours after injection with contrast media, or who would have a biopsy within 24 hours before planned injection with contrast media \n\n Patients who are likely to have any therapy or change in therapy between the study MRI and the procedures for the SOR", - "brief_summary": "Participants who had been diagnosed or suspected by doctors to have focal liver lesions that need further evaluation in order to make an accurate diagnosis. Participants would need to have an enhanced magnetic resonance imaging (MRI) scan so that doctors could have further information about the number and characteristics of the focal liver lesions.~Participants were invited to take part in this clinical study. The purpose of this study was to evaluate Primovist, which is a liver-specific MRI contrast medium, on the efficacy of lesion detection and characterization, and tolerability in Chinese patients with known or suspected focal liver lesions.~Primovist, the investigational drug in this study, is a liver-specific MRI contrast medium developed by Bayer Schering Pharma AG. Its active substance is Gd-EOB-DTPA. Primovist was first approved in 2004 in Sweden followed by an approval in the European community, in Switzerland and Australia in the same year.~Procedures:~Before entry into the study and after entry of the study a physical examination was conducted, blood pressure and heart rate were measured, blood and urine samples were taken. Current medications and medical conditions (including suspected pregnancy) and medical and surgical history were elicited by doctors.~After entry into the study, participants were scheduled to have an MRI examination, which lasted about 25-35 minutes.~During the MRI examination, an initial MRI scan without contrast was acquired which followed by another MRI series after the intravenous administration of Primovist.~The following day participants were asked to return to the hospital for a follow-up safety evaluation.~Possible Benefit Participants were scheduled to receive an enhanced magnetic resonance imaging scan. Clinical studies indicated that Primovist increased the efficacy of detection and characterization of focal liver lesions by providing better contrast between the focal liver lesions and surrounding normal tissue. Primovist were shown to provide additional information regarding existence, number and characterization (lesion or non-lesion, malignant or benign) of these abnormalities.~Based on the experience with patients given Primovist, some adverse reactions were observed.~Most of undesirable effects were transient and of mild to moderate intensity. The most commonly noted adverse events (AEs) in subjects receiving Primovist for MRI were nausea and headache with an incidence of 1.1%. Other AEs that occurred in 0.5% of the subject population were feeling hot (0.8%), back pain (0.6%) and dizziness (0.5%).~All other AEs occurred in less than 0.5% of the patients, e.g. anxiety; coughing; eye disorder; fever; flatulence; generalized spasm; hypertension; injection site symptoms including edema, inflammation, and reaction; lightheadedness; parosmia; postural hypotension; taste perversion, motoric unrest; acute respiratory distress; fatigue; malaise; vomiting; palpitations, erythema, chest pain and back pain.~Coldness, warmth or pain at the injection site, injection site reaction, and injection site accumulation of fluid were rare. In very rare cases strong allergy-like reactions ranging to shock may occur.~Post-marketing tachycardia and restlessness have been reported. As in the case of other investigational drugs, there may also be unforeseen side effects.~Additional information concerning all Gadolinium- based contrast agents Primovist contains the rare earth metal gadolinium as active ingredient. There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents (especially Omniscan) in patients with severe renal impairment. NSF is a systemic disease characterised by formation of connective tissue in the skin, which becomes thickened and hard, sometimes leading to contractures and joint immobility. The clinical course is usually progressive and currently no treatment is available. To date NSF has only been reported in association with some Gd-containing contrast agents, but the role of these contrast agents in the overall pathogenesis of the disease is still not completely understood.~No reports of patients with NSF after administration of Primovist\u00ae are known. The risk to trigger NSF in risk patients with severe renal impairment is considered to be low for Primovist\u00ae due to the low dose given and the additional excretion via feces. Furthermore the participation of patients with severe renal impairment are excluded from this study.~In case the participants were suffering from renal insufficiency, they were told to tell their doctors prior to application of the contrast agent. In case the participants experienced any new alterations of the skin following the administration of the contrast agent, they were told to contact their doctors as soon as possible after they had recognized these symptoms.", - "NCTID": "NCT00526188" - }, - { - "brief_title": "Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis", - "phase": "", - "drugs": "['Pancrelipase']", - "drugs_list": [ - "Pancrelipase" - ], - "diseases": "['Cystic Fibrosis', 'Exocrine Pancreatic Insufficiency', 'Pancreatic Diseases', 'Digestive System Diseases']", - "diseases_list": [ - "Cystic Fibrosis", - "Exocrine Pancreatic Insufficiency", - "Pancreatic Diseases", - "Digestive System Diseases" - ], - "enrollment": "24.0", - "inclusion_criteria": "inclusion criteria \n\n Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency due to cystic fibrosis \n\n ", - "exclusion_criteria": " \n\n Patients with a history of hypersensitivity to the ingredient of LipaCreon. \n\n Patients with a history of hypersensitivity to porcine protein", - "brief_summary": "This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients due to cystic fibrosis receiving the treatment with LipaCreon in order to evaluate the effective and safe use of LipaCreon.", - "NCTID": "NCT01427712" - }, - { - "brief_title": "Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers", - "phase": "Phase 4", - "drugs": "['Budesonide 2 single doses, Metronidazole multiple-dose']", - "drugs_list": [ - "Budesonide 2 single doses", - "Metronidazole multiple-dose" - ], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy male subjects \n\n Caucasian origin \n\n Age: between 18 and 55 years (inclusive) \n\n Body mass index (BMI) within 18-30 kg/m\u00b2 \n\n Body weight at least 50 kg, at most 100 kg \n\n Non-smoker (or ex-smoker \u22651 year), proven by urine cotinine <500 ng/ml \n\n Clinically acceptable supine blood pressure and pulse rate, i.e. BP 100-145 mmHg systolic, 60-90 mmHg diastolic and pulse rate 50-100 bpm \n\n Normal ECG \n\n Participants must perform an adequate contraception during the study and until 6 months after the last dose of the present trial \n\n Ability to communicate well with the investigator and comply with the requirements of the entire study \n\n Written consent \n\n ", - "exclusion_criteria": ": \n\n Subjects with contraindications for budesonide \n\n Subjects with contraindications for metronidazole \n\n History or current clinical evidence of any cardiac, cardio-vascular, pulmonary, gastrointestinal, (cholangio-)hepatic, renal, endocrine, neurological, musculoskeletal, ophthalmological, infectious, haematological, oncological, psychiatric, or other acute or chronic diseases and/or pathological findings which might interfere with the drugs' safety, tolerability, absorption and/or pharmacokinetics \n\n History or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food \n\n Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables \n\n Current smoker or ex-smoker \u2264 1 year \n\n Excessive alcohol consumption (\u00b3 35 g/day in males) \n\n Abuse of drugs \n\n Positive drug screening \n\n Positive anti-HIV-test, HBsAg-test or anti-HCV-test \n\n Proneness to orthostatic dysregulation, faintings, or blackouts \n\n Heavy tea or coffee drinkers (more than 1 l \u2248 6 cups per day) \n\n Administration of glucocorticosteroids within 6 weeks prior to study day 1 or during the trial \n\n Repeated use of drugs during the last 4 weeks prior to study day 1 or during the trial, which might influence hepatic biotransformation \n\n Any medication including OTC medication within the last 14 days prior to study day 1 or during the trial (single intake of a drug may be accepted if judged by the investigators to have no clinical relevance and no relevance for the study objectives) \n\n Intake of grapefruit-containing food or beverages within 7 days prior to study day 1 or during the trial \n\n Clinically relevant acute or chronic bacterial, fungal or viral infections \n\n Surgery of the gastrointestinal tract which may interfere with drug absorption (not applicable for minor abdominal surgery such as e.g. appendectomy and herniotomy) \n\n Vegetarian diet or other peculiar dietary habits which would preclude the subject's acceptance of standardized (non-vegetarian) meals \n\n Subjects suspected or known not to follow instructions \n\n Subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study \n\n Patients known to be in financial difficulties, which could interfere with their appraisal of the informative instructions \n\n Vulnerable subjects (e.g., persons kept in detention or persons who are depending on the sponsor or the investigator) \n\n Blood donation or other blood loss of more than 400 ml within the last 2 months prior to study day 1 \n\n Participation in a clinical trial within the last 2 months prior to study day 1 (assessed by anamnestic inquiry)", - "brief_summary": "The primary objective of this study is to describe a possible effect of metronidazole on PK of budesonide in healthy volunteers.", - "NCTID": "NCT00338910" - }, - { - "brief_title": "Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral Tablet", - "phase": "Phase 1", - "drugs": "['Viagra 50 mg tablet', 'Formulation B ODT tablet 50 mg', 'Formulation C ODT tablet 50 mg', 'Formulation D ODT tablet 50 mg']", - "drugs_list": [ - "Viagra 50 mg tablet", - "Formulation B ODT tablet 50 mg", - "Formulation C ODT tablet 50 mg", - "Formulation D ODT tablet 50 mg" - ], - "diseases": "['Healthy Volunteers']", - "diseases_list": [ - "Healthy Volunteers" - ], - "enrollment": "16.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy subjects \n\n Weight: BMI from 17.5 to 30.5 \n\n ", - "exclusion_criteria": ": \n\n Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). \n\n A positive urine drug screen.", - "brief_summary": "The bioavailability of the oral disintegrating tablet formulations given without water will be similar to an equivalent dose of the standard oral tablet given with water.", - "NCTID": "NCT00950404" - }, - { - "brief_title": "A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia", - "phase": "", - "drugs": "['Zidovudine', 'Sargramostim']", - "drugs_list": [ - "Zidovudine", - "Sargramostim" - ], - "diseases": "['HIV Infections', 'Cytopenias']", - "diseases_list": [ - "HIV Infections", - "Cytopenias" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria \n\n Patients must have: \n\n Serum antibody to HIV with or without evidence of HIV antigenemia. \n\n White blood cells (WBC) = or < 4500 cells/mm3 measured on at least 2 occasions separated by a minimum of 1 week. \n\n Qualifying indications for AZT therapy. \n\n Life expectancy = or > 6 months. \n\n ", - "exclusion_criteria": " \n\n Co-existing Condition: \n\n Patients with the following conditions or symptoms are excluded: \n\n Current or past history of malignancy including Kaposi's sarcoma. \n\n Excessive diarrhea or significant malabsorption. \n\n If patients have had > 10 percent weight loss within the past 3 months, they should not have malabsorption as evidenced by serum carotene < 75 IU/ml, serum vitamin A < 75 IU/ml, significant malabsorption 4 foul-smelling or greasy stools per day or other criteria. \n\n Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (IO). \n\n Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP). \n\n Active OI requiring systemic treatment. \n\n Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia. \n\n Concurrent Medication: \n\n Excluded within 4 weeks of study entry: \n\n Zidovudine (AZT). \n\n Other antiviral agent associated with leukopenia. \n\n Investigational drug. \n\n Immunomodulators. \n\n Interferon. \n\n Steroids. \n\n Excluded within 8 weeks of study entry: \n\n Ribavirin. \n\n Excluded within 4 months of study entry: \n\n Suramin. \n\n Patients with the following are excluded: \n\n Current or past history of malignancy including Kaposi's sarcoma. \n\n Excessive diarrhea or significant malabsorption. \n\n Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (OI). \n\n Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP). \n\n Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia. \n\n Prior Medication: \n\n Excluded: \n\n Prophylactic therapy for Pneumocystis carinii pneumonia (PCP) that may cause leukopenia. \n\n Risk Behavior: \n\n Excluded: \n\n Current drug or alcohol abusers. \n\n Unprotected sexual contact or other activities that may result in reinfection with HIV. \n\n Patients must be willing to refrain from unprotected sexual contact or other activities that may result in reinfection with HIV.", - "brief_summary": "To evaluate the safety of repeated courses of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) administered subcutaneously to patients with HIV infection and leukopenia. To determine if administration of GM-CSF will prevent some or all of the hematologic toxicity associated with zidovudine ( AZT ) treatment in patients with pre-existing leukopenia. To assess any clinical and/or virologic benefits from administering alternating weeks of GM-CSF and AZT to patients with symptomatic HIV infection who have a history of cytologically confirmed Pneumocystis carinii pneumonia ( PCP ) or a circulating absolute CD4 lymphocyte count less than 200 cells/mm3.", - "NCTID": "NCT00002007" - }, - { - "brief_title": "A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas", - "phase": "Phase 1; Phase 2", - "drugs": "['Mebendazole', 'Vincristine', 'Carboplatin', 'Temozolomide', 'Bevacizumab', 'Irinotecan']", - "drugs_list": [ - "Mebendazole", - "Vincristine", - "Carboplatin", - "Temozolomide", - "Bevacizumab", - "Irinotecan" - ], - "diseases": "['DIPG', 'Pilomyxoid Astrocytoma', 'Pilocytic Astrocytoma', 'Glioma, Astrocytic', 'Optic Nerve Glioma', 'Pleomorphic Xanthoastrocytoma', 'Glioblastoma Multiforme', 'Anaplastic Astrocytoma', 'Diffuse Intrinsic Pontine Glioma', 'Low-grade Glioma', 'Brainstem Glioma', 'Gliosarcoma']", - "diseases_list": [ - "DIPG", - "Pilomyxoid Astrocytoma", - "Pilocytic Astrocytoma", - "Glioma", - "Astrocytic", - "Optic Nerve Glioma", - "Pleomorphic Xanthoastrocytoma", - "Glioblastoma Multiforme", - "Anaplastic Astrocytoma", - "Diffuse Intrinsic Pontine Glioma", - "Low-grade Glioma", - "Brainstem Glioma", - "Gliosarcoma" - ], - "enrollment": "36.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 1 year of age and \u2264 21 years of age \n\n Diagnosis \n\n 2.1. Group A - Low-grade Glioma Group: \n\n Histology: Biopsy-proven: \n\n Pilocytic Astrocytoma \n\n Fibrillary Astrocytoma \n\n Pilomyxoid Astrocytoma \n\n Pleomorphic Xanthoastrocytoma \n\n Other low grade astrocytomas \n\n Children with optic pathway tumors must have evidence of progressive disease on MRI and/or symptoms of deteriorating vision or, progressive hypothalamic/pituitary dysfunction or, diencephalic syndrome or precocious puberty. \n\n Patients with relapsed low-grade gliomas who have been previously treated with chemotherapy will be eligible for the study provided they have not previously failed therapy with any of the chemotherapeutic agents used in this study. \n\n 2.2 Group B - High-grade Glioma/Pontine Glioma Group: \n\n Histology: Biopsy-proven \n\n Anaplastic astrocytoma \n\n Glioblastoma multiforme \n\n Gliosarcoma. \n\n Patients with primary spinal cord malignant gliomas are eligible. \n\n For primary brainstem tumors, histologic verification is not required. Patients are eligible when diagnosed with clinical and radiographic (MRI) evidence of tumors which diffusely involve the brainstem. Patients with tumors which intrinsically (greater than 50% intra-axial) involve the pons or pons and medulla or pons and midbrain or entire brainstem are eligible. Tumors may contiguously involve the thalamus or upper cervical cord. \n\n Timing of therapy: \n\n Patients must be enrolled before treatment begins. Treatment must start within 14 days of study enrollment. \n\n All clinical and laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated in the eligibility section. \n\n Adequate hematologic, renal, liver function as demonstrated by laboratory values. \n\n Negative pregnancy test in women of childbearing potential within 7 days of initiating investigational therapy \n\n Life expectancy \u2265 3 months \n\n Concurrent medications: It is recommended that patients are weaned off or are on a tapering dose of corticosteroids before starting therapy on study. \n\n Patient or legal guardian must give written, informed consent or assent (when applicable) \n\n Recent mothers must agree not to breast feed while receiving medications on study. \n\n ", - "exclusion_criteria": ": \n\n Age < 1 year or > 21 years \n\n Patients who have known allergy to mebendazole or benzimidazole class drugs. \n\n Patients who have previously had a severe side effect, such as agranulocytosis and neutropenia, in conjunction with previous mebendazole or benzimidazole class drug for a parasitic infection . \n\n Patients who are taking metronidazole and cannot be safely moved to a different antibiotic greater than 7 days prior to starting mebendazole therapy. \n\n Pregnant female patients are not eligible for this study. Pregnancy tests with a negative result must be obtained in all post-menarchal females. \n\n Lactating females must agree they will not breastfeed a child while on this study. \n\n Males and females of reproductive potential may not participate unless they agree to use an effective contraceptive method and continue to do so for at least 6 months after the completion of therapy. \n\n Patients who are unable to take oral medications because of significant vomiting will be excluded. \n\n Group A - Low-grade Glioma Group ONLY: \n\n Patients who have failed prior chemotherapy with vincristine, carboplatin, or temozolomide for this tumor are excluded. \n\n Patients with Neurofibromatosis Type 1 \n\n Group B - High-grade Glioma/Pontine Glioma Group ONLY: \n\n Patients who failed prior chemotherapy with bevacizumab or irinotecan for this tumor are excluded. \n\n Patients who progressed on or within 12 weeks after completion of radiotherapy are excluded. \n\n Patients with a history or current condition that would preclude the use of bevacizumab", - "brief_summary": "This is a study to determine the safety and efficacy of the drug, mebendazole, when used in combination with standard chemotherapy drugs for the treatment of pediatric brain tumors. Mebendazole is a drug used to treat infections with intestinal parasites and has a long track record of safety in humans. Recently, it was discovered that mebendazole may be effective in treating cancer as well, in particular brain tumors. Studies using both cell cultures and mouse models demonstrated that mebendazole was effective in decreasing the growth of brain tumor cells.~This study focuses on the treatment of a category of brain tumors called gliomas. Low-grade gliomas are tumors arising from the glial cells of the central nervous system and are characterized by slower, less aggressive growth than that of high-grade gliomas. Some low-grade gliomas have a more aggressive biology and an increased likelihood of resistance or recurrence.~Low-grade gliomas are often able to be treated by observation alone if they receive a total surgical resection. However, tumors which are only partially resected and continue to grow or cause symptoms, or those which recur following total resection require additional treatment, such as chemotherapy. Due to their more aggressive nature, pilomyxoid astrocytomas, even when totally resected, will often be treated with chemotherapy. The current first-line treatment at our institution for these low-grade gliomas involves a three-drug chemotherapy regimen of vincristine, carboplatin, and temozolomide. However, based on our data from our own historical controls, over 50% of patients with pilomyxoid astrocytomas will continue to have disease progression while on this treatment. We believe that mebendazole in combination with vincristine, carboplatin, and temozolomide may provide an additional therapeutic benefit with increased progression-free and overall survival for low-grade glioma patients, particularly for those with pilomyxoid astrocytomas.~High grade gliomas are more aggressive tumors with poor prognoses. The standard therapy is radiation therapy. A variety of adjuvant chemotherapeutic combinations have been used, but with disappointing results. For high-grade gliomas this study will add mebendazole to the established combination of bevacizumab and irinotecan to determine this combinations safety and efficacy", - "NCTID": "NCT01837862" - }, - { - "brief_title": "Prevention of Persistence of Bacterial Vaginosis", - "phase": "Phase 3", - "drugs": "['intravaginal metronidazole']", - "drugs_list": [ - "intravaginal metronidazole" - ], - "diseases": "['Bacterial Vaginosis']", - "diseases_list": [ - "Bacterial Vaginosis" - ], - "enrollment": "117.0", - "inclusion_criteria": "inclusion criteria: \n\n women 18-40 yrs old \n\n abnormal vaginal discharge or malodor \n\n positive QuickVue test \n\n positive KOH whiff test \n\n Positive finding of clue cells greater than or equal to 20% on wet mount \n\n Able to give informed consent \n\n willing to abstain from alcohol during the 5 day therapy and 1 day following \n\n ", - "exclusion_criteria": ": \n\n immunocompromised women \n\n symptomatic VVC \n\n pregnancy or positive pregnancy test \n\n menstruating or breastfeeding women \n\n other oral or vaginal antifungal or antimicrobial drugs w/in past 2 wks \n\n women with MPC, PID", - "brief_summary": "This purpose of this study will be to conduct a double-blind, randomized, controlled clinical trial to determine the association between intravaginal high dose metronidazole (750mg), intravaginal high dose metronidazole combined with an antifungal agent(750mg metronidazole + 200mg miconazole) and low dose (37.5mg) intravaginal metronidazole, with the rate of persistent bacterial vaginosis.", - "NCTID": "NCT00741845" - } - ], - "1": [ - { - "brief_title": "Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence", - "phase": "Phase 3", - "drugs": "['Loperamide hydrochloride + simethicone chewable tablet', 'Loperamide hydrochloride', 'Loperamide hydrochloride + simethicone chewable placebo tablet', 'Loperamide hydrochloride placebo capsule']", - "drugs_list": [ - "Loperamide hydrochloride + simethicone chewable tablet", - "Loperamide hydrochloride", - "Loperamide hydrochloride + simethicone chewable placebo tablet", - "Loperamide hydrochloride placebo capsule" - ], - "diseases": "['Diarrhea']", - "diseases_list": [ - "Diarrhea" - ], - "enrollment": "217.0", - "inclusion_criteria": "inclusion criteria: \n\n Participant's symptoms of acute diarrhea must manifest within 48 hours prior to entering the trial \n\n Participant must have experienced at least three incidences of unformed stool within 24 hours prior to entering the trial (referring to any instances of watery stool or soft stool as determined after placing the stool in a container) \n\n Participant's most recently produced stool must be unformed stool \n\n Participant must give a positive answer to the following question: Have you felt any abdominal discomfort caused by gastrointestinal gas accumulation within the last hour \n\n Female participants must take effective contraceptive measures throughout the trial (including oral or injectable contraceptives, contraceptive tools, ligation) or be postmenopausal \n\n ", - "exclusion_criteria": ": \n\n Participant hospitalized for treatment of severe acute diarrhea or otherwise requires intravenous fluids or antibiotics on an outpatient basis \n\n Participant shows an axillary temperature greater than (>) 38.2 degrees Celsius (C) or an oral temperature > 38.6 degrees C \n\n Participant shows clinical symptoms of bloody or purulent stool or erythrocytes or leukocytes are detected in the participant's stool at > 3 per high power field \n\n Participant shows a sitting systolic blood pressure less than (<) 90 millimeter of mercury (mmHg) and/ or diastolic blood pressure < 60 mmHg \n\n Participant is unable to take medication orally or tolerate oral rehydration", - "brief_summary": "The purpose of this study is to evaluate the efficacy and safety of combined loperamide hydrochloride and simethicone compared to loperamide hydrochloride monotherapy in treating acute diarrhea associated with abdominal discomfort caused by gastrointestinal gas accumulation.", - "NCTID": "NCT02340481" - }, - { - "brief_title": "Fecal Microbiota Therapy for Recurrent Clostridium Difficile Colitis", - "phase": "", - "drugs": "['Stool']", - "drugs_list": [ - "Stool" - ], - "diseases": "['Clostridium Difficile']", - "diseases_list": [ - "Clostridium Difficile" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients > 18 years of age \n\n The patient has been treated with appropriate antimicrobial therapy for CDI. \n\n The patient has documented relapse/recurrence of infection as demonstrated by positive stool culture, or cytotoxin assay, or PCR toxin assay. \n\n Since this study does not involve treatments that have potential teratogenicity, and in general avoidance of antimicrobial treatment during pregnancy is advised (metronidazole is pregnancy category C), women of child-bearing age may be included in the study. \n\n ", - "exclusion_criteria": ": \n\n - Patients will be excluded from study participation if one of the following categories of ", - "brief_summary": "This study was developed in response to the July, 2013 FDA draft guidance regarding FMT for CDI. The weight of the evidence in the literature suggests that FMT is the most effective treatment for ambulatory outpatients affected by recurrent CDI who fail conventional therapy.~The anticipated benefits to research patients enrolled in this study include resolution of chronic diarrhea, return of bowel habits and nutritional status to normal, and resolution of chronic recurrent CDI.~FMT involves the endoscopic instillation of freshly obtained stool with millions of live bacteria into the recipient's colon by endoscopic lavage. With any endoscopic procedure, there is a risk of perforated viscous. This is very rare, but the risk is increased with severe CDI. The risk of acquisition of communicable enteric or blood borne pathogen appears to be negligible.", - "NCTID": "NCT01973465" - }, - { - "brief_title": "Efficacy and Safety of Fecal Microbiota Transplantation for Severe Clostridium Difficile Associated Colitis", - "phase": "", - "drugs": "['fecal microbiota transplantation']", - "drugs_list": [ - "fecal microbiota transplantation" - ], - "diseases": "['Clostridium Difficile']", - "diseases_list": [ - "Clostridium Difficile" - ], - "enrollment": "3.0", - "inclusion_criteria": "inclusion criteria: \n\n Both genders are eligible for study \n\n Age 18 years and older \n\n Able to provide written, informed consent \n\n Confirmed diagnosis of severe CDAD as defined above \n\n ", - "exclusion_criteria": ": \n\n (If any of the following apply, the subject MUST NOT enter the study): \n\n Pregnant or lactating women \n\n Need for prolonged antibiotics for other cause \n\n Other known etiology for diarrhea, or clinical infection with other known enteric pathogens \n\n Active, chronic conditions such as: Inflammatory bowel disease, Crohn's disease, Short bowel syndrome, Ulcerative or ischemic colitis \n\n Laxatives or motility-altering drugs within 12 hours of enrolment \n\n Clinically unstable. Hemodynamic instability defined as hypotension (mean arterial pressure < 60) not responsive to fluids. \n\n Any condition that, in the opinion of the investigator, would preclude safe participation in the trial or compromise the quality of the data obtained. \n\n Immune suppression, HIV, hematological or solid malignancy (chemotherapy in the past 3 months). \n\n Prior colon surgery", - "brief_summary": "Clostridium difficile has become one of the leading causes of hospital acquired infections, and is associated with increased mortality. Patients with C. difficile associated disease (CDAD) possess deficiencies in 'normal' fecal microbial composition, most likely as a result of earlier antibiotic usage. The current standard of care treatment for severe C. difficile, which consists of antibiotics, does not restore the microbiota. Restoration of the normal colonic microbiota by fecal microbiota transplantation (FMT) may enable reversion colonic microbial population to a more 'normal'state and lead to cure.~A few patients develop severe CDAD which may be complicated by adynamic ileus, or toxic megacolon. The management in this context is based on limited data, and for some the only available option is sub-total colectomy.~Although FMT is by no means a new therapeutic modality, there is limited information on its use for the treatment of acute CDAD, including severe CDAD. Because of the high morbidity and mortality associated with treatment of patients with severe CDAD, and because the evidence supporting the current recommendations is weak and based upon the demonstration that FMT is an effective strategy to re-establish a balanced intestinal microbiota with resultant cure of recurrent CDAD, we propose to study the efficacy and safety of FMT for severe CDAD.~Patients with severe CDAD can be divided into two operational groups; those that have diarrhea and those that suffer from adynamic ileus. We propose to apply FMT through colonoscopy for all patients because current data suggest that the overall success rate of FMT for recurrent CDAD with lower gastrointestinal tract FMT was higher than FMT through the upper gastrointestinal tract. In addition, for patients with adynamic ileus and toxic megacolon (i.e., the population with the highest CDAD-associated morbidity and mortality), intra-colonic FMT administration is the preferred alternative.", - "NCTID": "NCT01959048" - }, - { - "brief_title": "A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis", - "phase": "Phase 2", - "drugs": "['Metronidazole', 'Metronidazole-DRF1', 'Metronidazole-DRF2']", - "drugs_list": [ - "Metronidazole", - "Metronidazole-DRF1", - "Metronidazole-DRF2" - ], - "diseases": "['Clostridium Difficile Associated Diarrhea']", - "diseases_list": [ - "Clostridium Difficile Associated Diarrhea" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female patients 18 years of age or older \n\n Mild to moderate C.difficile associated diarrhea (CDAD) with a positive stool C.difficile toxin (by ELISA). \n\n Either a first episode of CDAD or a first recurrence (patients with more than 1 recurrence are not eligible) \n\n Greater than 3 watery or unformed bowel movements in the prior 24 hours \n\n Females of child bearing potential having a negative pregnancy test and taking adequate birth control measures. \n\n Patients should not consume alcohol at least 12 hours prior to dosing (i.e. in-house monitoring) and until 48 hours after the last dose of drug administration (until Day 14). \n\n Able to comprehend and give informed consent for the study and able to adhere to study schedules and protocol requirements. \n\n ", - "exclusion_criteria": ": \n\n Known prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives \n\n Life expectancy \u2264 60 days \n\n Sepsis, severe sepsis, or septic shock \n\n Signs or symptoms of peritonitis, megacolon or ileus \n\n History of ulcerative colitis or Crohn's disease \n\n Oral or parenteral antibiotic therapy with metronidazole or vancomycin or other drugs effective in treating DCAD (e.g., bacitracin, fusidic acid) within the 1 week prior to enrollment \n\n Recent history of significant drug or alcohol abuse within 1 year \n\n Any findings on physical examination, medical history, 12-lead ECG or clinical laboratory tests which, in the judgment of the Principal Investigator, would exclude patients from participating in the study \n\n Patients with history of blood dyscrasias, porphyria and active non-infectious disease of the central nervous system \n\n Patients with history of rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption \n\n Pregnant or lactating female patients \n\n Participation within 30 days before the start of this study in any experimental drug or device study, or currently participating in a study in which the administration of investigational drug or device within 60 days is anticipated \n\n Unable to participate in the study for any reason in the opinion of the Principal Investigator", - "brief_summary": "Clostridium difficile bacteria can be a cause of significant diarrheal disease, particularly in people who have taken potent antibiotics. When C. difficile multiplies within the colon, it produces two toxins that cause inflammation and resultant abdominal pain, fever and diarrhea. Current treatment of mild to moderate disease is with immediate release metronidazole, an antibiotic that kills C. difficile. Dr. Reddy's Laboratories has developed a delayed release form of metronidazole to release just before the colon to increase the concentration of antibiotic in the colon to improve the effectiveness of metronidazole treatment and potentially to allow less whole body exposure to the antibiotic.~This study will measure the amount of metronidazole in the blood and stool of patients with C. difficile associated diarrhea (CDAD) to confirm that the new formulations are releasing the antibiotic as designed, immediately before the colon.", - "NCTID": "NCT01559545" - } - ], - "2": [ - { - "brief_title": "Diagnosis of Neglected Tropical Diseases Among Patients With Persistent Digestive Disorders", - "phase": "", - "drugs": "['Stool culturing for pathogenic bacteria', 'Kato-Katz technique', 'Baermann technique', 'Mini-FLOTAC', 'Crypto/Giardia Duo Strip', 'Formalin-ether concentration technique', 'CCA RDT', 'Koga agar plate culture', 'Kinyoun staining', 'Multiplex PCR', 'Metagenomics analysis']", - "drugs_list": [ - "Stool culturing for pathogenic bacteria", - "Kato-Katz technique", - "Baermann technique", - "Mini-FLOTAC", - "Crypto/Giardia Duo Strip", - "Formalin-ether concentration technique", - "CCA RDT", - "Koga agar plate culture", - "Kinyoun staining", - "Multiplex PCR", - "Metagenomics analysis" - ], - "diseases": "['Soil-transmitted Helminthiasis', 'Schistosomiasis', 'Strongyloidiasis', 'Shigellosis', 'Intestinal Salmonellosis', 'Campylobacteriosis', 'Aeromonas Spp. Infections', 'Giardiasis', 'Amoebiasis', 'Dientamoebiasis', 'Cryptosporidium Spp. Infections']", - "diseases_list": [ - "Soil-transmitted Helminthiasis", - "Schistosomiasis", - "Strongyloidiasis", - "Shigellosis", - "Intestinal Salmonellosis", - "Campylobacteriosis", - "Aeromonas Spp. Infections", - "Giardiasis", - "Amoebiasis", - "Dientamoebiasis", - "Cryptosporidium Spp. Infections" - ], - "enrollment": "2800.0", - "inclusion_criteria": "inclusion criteria: \n\n Individuals aged \u22651 year presenting with persistent diarrhoea (\u22653 loose stools per days for \u22652 weeks; symptomatic group) and/or children (aged 1-18 years) with persistent abdominal pain (localized or diffuse abdominal pain lasting for \u22652 weeks, with possible intermittence/recurrence). \n\n Individuals with written informed consent provided. \n\n ", - "exclusion_criteria": ": \n\n Individuals in need of immediate intensive or surgical care. \n\n Individuals who are unable or unwilling to give written informed consent. \n\n Individuals who do not meet the inclusion criteria for being a case or control (e.g. people with acute diarrhoea). \n\n Individuals with clinical jaundice (assessed by direct observation of the conjunctivae). \n\n Individuals who are unable, in the study physician's opinion, to comply with the study requirements. \n\n Individuals who are already participating in other ongoing diagnostic studies and/or clinical trials.", - "brief_summary": "NIDIAG is an international collaboration on integrated diagnosis-treatment platforms, funded by the European Commission (EC). NIDIAG aims to develop an improved, patient-centred system for delivering primary health care in resource-constrained settings. NIDIAG will investigate three clinical syndromes, namely (i) persistent digestive disorders, (ii) persistent fever and (iii) neurological disorders, due to neglected tropical diseases (NTDs). The current study focuses on persistent digestive disorders, which are defined as diarrhoea or abdominal pain that last for at least 2 weeks.~While acute diarrhoea has been studied globally, few research activities have focused on the epidemiology, diagnosis and treatment of long-lasting diarrhoeal episodes (2 weeks and longer) in the tropics. The spectrum of possibly involved pathogens includes more than 30 bacterial, parasitic and viral infectious agents. This lack of data may be explained by the fact that people suffering from NTDs might only seek care at a late stage of the disease. Furthermore, health systems in affected regions are often weak and their primary health-care centres are often under-staffed and lack essential diagnostic equipment.~The hypothesis of this study is that development of an evidence-based syndromic approach can lead to better diagnosis and management of NTDs in patients with persistent digestive disorders. The study will be carried out in two West African countries (C\u00f4te d'Ivoire and Mali) and in two Asian countries (Indonesia and Nepal). The study will follow a case-control design and patients and controls will be prospectively enrolled. In order to address the knowledge gaps, three specific objectives will be pursued. First, the contribution of NTDs to the 'persistent digestive disorders syndrome' will be assessed. Second, the value of clinical features and rapid diagnostic tests (RDTs) for the diagnosis of target NTDs that give rise to persistent digestive disorders will be determined. Third, the clinical response to standard empiric and targeted treatment of several NTDs in patients with persistent digestive disorders will be evaluated. These objectives will provide a long-term benefit for the communities by improving the clinical decision-making process for the target NTDs and thus, better diagnostic work-up and patient management can be achieved in the study countries and other similar resource-constrained countries", - "NCTID": "NCT02105714" - }, - { - "brief_title": "Study Comparing Rifaximin With Xifaxan 200 mg in Traveler's Diarrhea", - "phase": "Phase 3", - "drugs": "['Rifaximin', 'Xifaxan\u00ae', 'Placebo Tablet']", - "drugs_list": [ - "Rifaximin", - "Xifaxan\u00ae", - "Placebo Tablet" - ], - "diseases": "['Diarrhea']", - "diseases_list": [ - "Diarrhea" - ], - "enrollment": "739.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult male or nonpregnant female aged \u226518 years non-indigenous travelers (for example; visiting students/faculty or international tourists) affected by naturally acquired acute diarrhea. Diarrhea is defined as the passage of at least 3 unformed stools in a 24-hour period. Stools are classified as formed (retains shape), soft (assumes shape of container), or watery (can be poured). When using this classification, both soft and watery stools are unformed and abnormal. \n\n At least 3 unformed stools recorded within the 24 hours immediately preceding randomization. \n\n At least 1 of the following signs and symptoms of enteric infection: \n\n abdominal pain or cramps \n\n nausea \n\n vomiting \n\n fecal urgency \n\n excessive gas/flatulence \n\n tenesmus \n\n Women of child-bearing potential have a negative pregnancy test prior to beginning therapy and agree to use effective contraceptive methods during the study. \n\n ", - "exclusion_criteria": ": \n\n Pregnant, breast feeding, or planning a pregnancy. \n\n Immediately prior to randomization, acute diarrhea for >72 hours. \n\n Presence of: \n\n fever (\u2265100 degrees fahrenheit [\u00b0F] or \u226537.8 degrees celsius [\u00b0C]), or \n\n hematochezia (blood in stool), or \n\n clinical findings suggesting moderate or severe dehydration. \n\n Active, uncontrolled, or clinically significant diseases or disorders of the heart, lung, kidney, gastrointestinal (GI) tract (other than infectious diarrhea in travelers), or central nervous system. \n\n Administration of any of the following: \n\n any antimicrobial agents with an expected activity against enteric bacterial pathogens within 7 days preceding randomization \n\n more than 2 doses of a symptomatic antidiarrheal compound such as antimotility agents, absorbent agents, and antisecretory agents within 8 hours preceding randomization \n\n Use of any drug such as aspirin or ibuprofen (Advil), which can cause GI bleeding. Acetaminophen (Tylenol) or paracetamol is acceptable.", - "brief_summary": "The primary objective is to demonstrate rifaximin 200 milligrams (mg) tablets (test) and Xifaxan\u00ae 200 mg tablets (reference) are clinically bioequivalent with respect to the clinical cure rates when administered 3 times a day (TID) for 3 days in participants with travelers' diarrhea.", - "NCTID": "NCT02498418" - }, - { - "brief_title": "300 Antibody Diagnostic Test Kit", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Acute Bacterial Infections', 'Acute Viral Infections']", - "diseases_list": [ - "Acute Bacterial Infections", - "Acute Viral Infections" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n current acute infection \n\n age 18-70 \n\n male or female \n\n any race \n\n currently active symptoms", - "exclusion_criteria": "", - "brief_summary": "For the development of a Point of Care IVD test kit for acute phase disease detection against a variety of bacterial and viral infections. Phase one includes 100 clinical diagnosed positive and 200 clinically normal serum and whole blood matched specimens for specificity and sensitivity determination for each marker. The positive samples must be IgM positive using any FDA cleared ELISA test kit. The negatives samples must be negative for IgM.", - "NCTID": "NCT01646411" - } - ] - }, - { - "patient_id": "sigir-201522", - "patient": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", - "0": [ - { - "brief_title": "Efficacy Of Itraconazole In Chronic Cavitary Pulmonary Aspergillosis", - "phase": "Phase 4", - "drugs": "['Itraconazole', 'treatment in cavitary pulmonary aspergillosis']", - "drugs_list": [ - "Itraconazole", - "treatment in cavitary pulmonary aspergillosis" - ], - "diseases": "['Chronic Cavitary Pulmonary Aspergillosis']", - "diseases_list": [ - "Chronic Cavitary Pulmonary Aspergillosis" - ], - "enrollment": "31.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical symptoms: -presence of chronic pulmonary/systemic symptoms lasting \u2265 six weeks. \n\n Radiological findings: \n\n Evidence of slowly progressive pulmonary lesions over weeks-months including cavities with surrounding inflammation. \n\n presence of intracavitary mass with a surrounding crescent of air,and presence of pleural thickening in peripheral lesions. \n\n Microbiological/Immunological findings: Positive results in the aspergillus precipitin test, demonstration of aspergillus hyphae in sputum or BAL fluid or cultures of BAL/sputum growing aspergillus species. \n\n The diagnosis of CCPA will be made if \n\n Patient satisfies at least 1, 2a or 2b and/ or any of the 3rd criteria. \n\n FNAC from the cavity wall will be considered in atypical cases \n\n ", - "exclusion_criteria": ": \n\n Invasive aspergillosis \n\n Allergic broncho-pulmonary aspergillosis (ABPA) \n\n Active tuberculosis or malignancy \n\n Pregnant females", - "brief_summary": "The purpose of this study is to determine whether there itraconazole is effective in the treatment of chronic cavitary pulmonary aspergillosis", - "NCTID": "NCT01259336" - }, - { - "brief_title": "Radiologic Features of Invasive Pulmonary Aspergillosis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Hematologic Disease', 'Solid Organ Transplantation']", - "diseases_list": [ - "Hematologic Disease", - "Solid Organ Transplantation" - ], - "enrollment": "130.0", - "inclusion_criteria": "inclusion criteria: \n\n IPA cases with solid organ transplant recipients and hematologic disease patients \n\n proven and probable invasive pulmonary aspergillosis by modified EORTC/MSG criteria \n\n ", - "exclusion_criteria": ": \n\n under 16 years old \n\n possible cases of invasive pulmonary aspergillosis", - "brief_summary": "Invasive pulmonary aspergillosis (IPA) is an opportunistic infection that primarily affects recipients of solid organ transplants (SOTs) and patients with chemotherapy- induced neutropenia.Although both of these populations are at high risk for IPA, they differ with regards to the specific defects in host defense mechanisms that increase their risk for IPA. Chemotherapy- induced neutropenia is the principal defect affecting patients with hematologic malignancies, whereas transplant recipients tend to have dysfunctional T cells and phagocytes, as a result of immunosuppressive drug therapy. Thus, the patterns of IPA-related infection and inflammation may differ according to the type of underlying immune defect. Although the clinical and radiological features of IPA in patients with neutropenia have been extensively studied, little is known about the characteristics of IPA in SOT recipients. The investigators therefore compared the IPA- related clinical and radiological findings in SOT recipients with those of neutropenic patients.", - "NCTID": "NCT01178177" - }, - { - "brief_title": "Inhalation of Liposomal Amphotericin B to Prevent Invasive Aspergillosis", - "phase": "Phase 2; Phase 3", - "drugs": "['nebulised liposomal amphotericin B']", - "drugs_list": [ - "nebulised liposomal amphotericin B" - ], - "diseases": "['Aspergillosis']", - "diseases_list": [ - "Aspergillosis" - ], - "enrollment": "320.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female hospitalized patients aged > 18 yr \n\n The patient has a hematologic malignancy or will receive a bone-marrow transplant \n\n The patient starts with a course of chemotherapy within 4 days or is already neutropenic at admission \n\n The expected duration of severe neutropenia (PMN<0.5x10*9/L) following study entry is > 10 days \n\n The patient is receiving oral antibiotic prophylaxis and fluconazole \n\n Written informed consent has been obtained \n\n ", - "exclusion_criteria": ": \n\n The patient shows evidence of a pulmonary fungal infection or a fungal sinusitis at trial entry \n\n The concomitant use of systemic anti-aspergillus treatment such as itraconazole or any intravenous formulation of amphotericin B at study entry \n\n Known hypersensitivity to amphotericin B \n\n Any evidence of pneumonia or pneumonitis at trial entry \n\n Any impossibility to use a nebulizer properly \n\n Expected survival < 3 months at entry \n\n Pregnancy", - "brief_summary": "A Phase II/III randomized double-blind study comparing the safety and the efficacy of a weekly administration of 25 mg nebulized AmBisome with nebulized placebo solution to prevent invasive pulmonary aspergillosis in neutropenic hemato-oncologic patients.", - "NCTID": "NCT00263315" - }, - { - "brief_title": "ATCF (Azole Therapy in Cystic Fibrosis)", - "phase": "Phase 2", - "drugs": "['Itraconazole/voriconazole']", - "drugs_list": [ - "Itraconazole/voriconazole" - ], - "diseases": "['Cystic Fibrosis', 'Aspergillus Infections']", - "diseases_list": [ - "Cystic Fibrosis", - "Aspergillus Infections" - ], - "enrollment": "11.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient with cystic fibrosis, \n\n men or women, \n\n age equal greater to 12 years, \n\n presenting with a positive sputum culture for Aspergillus confirmed twice within 6 months before study entry and at initial visit, \n\n written informed consent. \n\n ", - "exclusion_criteria": ": \n\n patients with a contraindication to one of the antifungal agents evaluated, \n\n pregnant women or nursing mothers, \n\n absence of an effective method of contraception in women of child-bearing potential, \n\n patients with signs or symptoms of invasive aspergillosis, \n\n patients with signs or symptoms of aspergilloma, \n\n patients with an infection caused by Burkholderia complex Cepacia or to mycobacteria, \n\n lung transplant patients, registered on a transplantation waiting list or whose registration is imminent, \n\n patients who received systemic antifungal therapy for more than 5 days within 2 months prior to inclusion, \n\n patients currently enrolled in another clinical drug trial, \n\n ongoing treatment with medicinal products contraindicated with itraconazole and voriconazole or with major interactions which reduce azole concentrations, \n\n patients treated by medication known to prolong QT interval, or with known prolongation of QTc interval > 450 msec in men and > 470 msec in women, \n\n Inability to follow or to understand the study procedures.", - "brief_summary": "Aspergillus infection is an infectious complication which frequently occurs in cystic fibrosis. The efficacy of azole therapy in patients with cystic fibrosis with persistent positive sputums for Aspergillus is still unknown. Furthermore, the efficacy of itraconazole and voriconazole in this indication has never been evaluated in a large prospective controlled clinical trial, even though many teams already use it. The ATCF study aims to assess in patients with cystic fibrosis with persistent Aspergillus positive cultures the efficacy of itraconazole and voriconazole on the negativisation of the sputum cultures for Aspergillus.", - "NCTID": "NCT01576315" - }, - { - "brief_title": "Nebulized Amphotericin B Lipid Complex in Invasive Pulmonary Aspergillosis in Paediatric Patients With Acute Leukaemia", - "phase": "Phase 2", - "drugs": "['AMPHOTERICIN B']", - "drugs_list": [ - "AMPHOTERICIN B" - ], - "diseases": "['Invasive Pulmonary Aspergillosis', 'Lymphoblastic Leukaemia', 'Myeloblastic Leukaemia', 'Lymphoblastic Leukemia', 'Myeloblastic Leukemia']", - "diseases_list": [ - "Invasive Pulmonary Aspergillosis", - "Lymphoblastic Leukaemia", - "Myeloblastic Leukaemia", - "Lymphoblastic Leukemia", - "Myeloblastic Leukemia" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n Age: patients between 3 and 18 years. \n\n Diagnosis of myeloblastic or lymphoblastic AL during intensive chemotherapy. \n\n Informed consent of parents/guardians and/or assent of the patient has been obtained. \n\n ", - "exclusion_criteria": ": \n\n Probable or proven invasive pulmonary fungal infection before entering the trial. \n\n Previous chronic renal impairment or baseline serum creatinine > 2.5 mg /dL \n\n Severe hepatic impairment. \n\n Moderate-severe asthma being treated pharmacologically. \n\n Antifungal treatment for filamentous fungi in the last 4 weeks. \n\n Participating or have participated in a clinical trial during the last 4 weeks. \n\n Mentally retarded \n\n Known allergy or hypersensitivity to the active ingredient of the study drug or to any of its excipients. \n\n Any serious concomitant disease that in the investigator's opinion could compromise the completion of the trial or affect the patient's tolerability to this treatment. \n\n Pregnancy (in women of fertile age). \n\n Breast-feeding. \n\n Patients are defined as having probable IFI when their radiological image is suggestive of fungal infection and they have positive antigenemia for Aspergillus. IFI would be proven when the presence of Aspergillus is confirmed in aspirate culture or by lung biopsy.", - "brief_summary": "The trial evaluates the overall tolerability of the drug and the efficacy of aerosolised amphotericin B as a lipid complex (ABLC) for primary prophylaxis of invasive pulmonary aspergillosis (IPA) in pediatric patients with acute leukemia undergoing intensive chemotherapy.", - "NCTID": "NCT01615809" - }, - { - "brief_title": "Nebulized Liposomal Amphotericin B Ambisome for Prophylaxis of Invasive Pulmonary Aspergillosis", - "phase": "Phase 2", - "drugs": "['liposomal Amphotericine B']", - "drugs_list": [ - "liposomal Amphotericine B" - ], - "diseases": "['Acute Myeloid Leukemia', 'Allogeneic Haematopoietic Progenitor Cell Transplant']", - "diseases_list": [ - "Acute Myeloid Leukemia", - "Allogeneic Haematopoietic Progenitor Cell Transplant" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient has decided voluntary to consent his or her participation signing the consent form before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. \n\n Patients with Acute myeloid Leukemia (AML), that will start induction chemotherapy or those patients submitted to an Allogeneic haematopoietic progenitor cell transplant. \n\n The patient is >18 years old. \n\n ", - "exclusion_criteria": ": \n\n Patient with prior Invasive Pulmonary Aspergillosis (IPA) history. \n\n History of allergy or hypersensitivity to Amphotericin B. \n\n Patient with intellectual deficit or patients with psychological alterations that make impossible the trial understanding. \n\n Pregnancy or breastfeeding. \n\n Patient has received other investigational drug or non traded product within 30 days before trial beginning. \n\n Patient is enrolled in another clinical research study or/and is receiving an investigational agent for any reason. \n\n Patient had major surgery within 4 weeks before enrollment.", - "brief_summary": "The trial is planned as a multicentric, national, phase II, open-label trial to evaluate safety and tolerance of nebulized Liposomal Amphotericin B (Ambisome) for LMA patients during the induction therapy ,intensification, plus Allogeneic Haematopoietic Progenitor Cell transplant in due course, as well for patients diagnosed of several malignant haematologic diseases and treated with Allogeneic Haematopoietic Progenitor Cell Transplant", - "NCTID": "NCT00391014" - }, - { - "brief_title": "Voriconazole for IPA in Chinese Patients With COPD", - "phase": "Phase 4", - "drugs": "['Voriconazole']", - "drugs_list": [ - "Voriconazole" - ], - "diseases": "['Invasive Pulmonary Aspergillosis', 'COPD']", - "diseases_list": [ - "Invasive Pulmonary Aspergillosis", - "COPD" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Cases of invasive pulmonary aspergillosis secondary to COPD \n\n ", - "exclusion_criteria": ": \n\n Use of voriconazole or itraconazole or amphotericin B or caspofungin or micafungin within 4 weeks prior to enrollment \n\n Known allergy to voriconazole \n\n Severe impairment of live or kidney function \n\n Septic shock \n\n Unwilling to sign informed consent", - "brief_summary": "voriconazole is recommended as first-line therapy for invasive pulmonary aspergillosis, however the efficacy and safety of voriconazole for treating invasive pulmonary aspergillosis secondary to COPD is not clear. This study aims to investigate the effectiveness and tolerability of intravenous voriconazole for treatment of invasive pulmonary aspergillosis in Chinese patients with COPD, by monitoring changes in clinical symptoms, eradication of aspergillus, improvement of chest imaging as well as record of possible adverse reactions following 2-week intravenous instillation of voriconazole.", - "NCTID": "NCT02234739" - }, - { - "brief_title": "A Multicentre Randomised Controlled Trial Comparing Two Strategies for the Diagnosis of Invasive Aspergillosis in High-risk Haematology Patients", - "phase": "Phase 3", - "drugs": "['Culture and histology', 'Aspergillus galactomannan and PCR']", - "drugs_list": [ - "Culture and histology", - "Aspergillus galactomannan and PCR" - ], - "diseases": "['Invasive Aspergillosis']", - "diseases_list": [ - "Invasive Aspergillosis" - ], - "enrollment": "240.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients fulfilling all the following criteria will be eligible for enrolment 1. Aged 18-80 years 2. Undergoing allogeneic haematopoietic stem cell transplantation (HSCT) for any reason OR Undergoing intensive combination chemotherapy for acute myeloid leukaemia (AML) or acute lymphoblastic leukaemia (ALL) 3. Has given written informed consent. \n\n - \n\n ", - "exclusion_criteria": ": \n\n Patients with any of the following will be ineligible for enrolment 1. Other immunocompromised states (e.g. HIV infection, solid organ transplantation, autoimmune conditions treated with immunosuppressants etc.) besides those outlined in the inclusion criteria above 2. Currently enrolled in an antifungal treatment trial (not an antifungal prophylaxis trial) 3. Past history of proven or probable IA (as per standardized definitions) during a previous cycle of chemotherapy 4. Currently have active IA or other active invasive fungal infection 5. Prior enrolment in this study \n\n -", - "brief_summary": "Aspergillus is a fungus found in soil, on farms and on construction sites. In those whose immune system is impaired it causes severe infection. The people who are particularly at high-risk of infection with Aspergillus (which is called Invasive Aspergillosis)are those with acute leukaemia who are having chemotherapy and those post bone marrow transplantation. Currently 15% of those at high-risk develop Invasive Aspergillosis and 60-90% of those with Invasive Aspergillosis die.~The main reason for this high death rate is that our current diagnostic tests are not good at detecting infection or often only detect the infection at advanced stages when treatment is ineffective. Because of the limitations of current diagnostic tests the current practice is to give empiric antifungal therapy (EAFT) early to treat suspected Invasive Aspergillosis. However studies have demonstrated that this therapy has only resulted in a minor reduction in the mortality rates and it also causes significant drug toxicity. It is a suboptimal treatment modality.~New tests have recently been developed to diagnose Invasive Aspergillosis. These tests are for the detection of an Aspergillus protein in blood and for the detection of Aspergillus DNA in blood. Available data suggests that these new tests make an early diagnosis and seem to be able to monitor responses to treatment. However no study has been reported to date which demonstrates that the use of these tests can impact on important patient outcomes. This trial is being performed to determine whether the use of the new diagnostic tests to guide antifungal therapy will help improve treatment of Invasive Aspergillosis, reduce drug toxicity and reduce the death rate in the high-risk patients as compared with the current standard method of diagnosis and treatment with EAFT.", - "NCTID": "NCT00163722" - }, - { - "brief_title": "Invasive Aspergillosis After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Hematological Diseases', 'Invasive Aspergillosis']", - "diseases_list": [ - "Hematological Diseases", - "Invasive Aspergillosis" - ], - "enrollment": "220.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 16 years \n\n Allogeneic HSCT for a haematological disease \n\n Written informed consent to the study \n\n ", - "exclusion_criteria": ": \n\n Pediatric patients", - "brief_summary": "Evaluation of incidence of invasive aspergillosis in patients who have undergone an allogeneic stem cell transplantation, with particular regard to the role of galactomannan assay and of early TC scan in asymptomatic patients.", - "NCTID": "NCT00838643" - }, - { - "brief_title": "To Determine Whether Galactomannan Test Will Help to Detect Fungal Infections Early and Hence Start Treatment Early", - "phase": "Phase 3", - "drugs": "['Galactomannan antigen monitoring, Aspergillus PCR', 'blood draws', 'blood draws for GM monitoring', 'Amphotericin-B deoxycholate', 'blood test', 'Blood test']", - "drugs_list": [ - "Galactomannan antigen monitoring", - "Aspergillus PCR", - "blood draws", - "blood draws for GM monitoring", - "Amphotericin-B deoxycholate", - "blood test", - "Blood test" - ], - "diseases": "['Aspergillosis']", - "diseases_list": [ - "Aspergillosis" - ], - "enrollment": "47.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with newly diagnosed acute leukemia or high risk myelodysplastic syndrome (MDS) receiving induction chemotherapy with expected duration of neutropenia (absolute neutrophil count of < 500/mL) of at least 10 days \n\n Patients with relapsed acute leukemia or MDS receiving salvage chemotherapy with expected duration of neutropenia (absolute neutrophil count of < 500/mL) of at least 10 days \n\n Patients with severe aplastic anemia (SAA) receiving chemotherapy or immunosuppressive therapy using antithymocyte globulin \n\n Patients receiving allogeneic/autologous hematopoeitic stem cell transplant (HSCT) using myeloablative conditioning regimens \n\n Patients are at least 12 years of age, with Karnofsky score of 70%.? \n\n Patients on consolidation chemo regimens like HIDAC and HyperCVAD type B with expected duration of neutropenia (ANC < 500/ml) of at least 10 days \n\n ", - "exclusion_criteria": ": \n\n Patients who are human immunodeficiency virus (HIV) infected \n\n Patients with uncontrolled bacteremia or active pulmonary infection at the time of randomisation \n\n Patients with pre-existing proven and probable invasive fungal infections, according to the definitions of the invasive Fungal Infections Cooperative Group of the European Organization for Research and Treatment of Cancer; Mycoses Study Group of the National Institute of Allergy and Infectious Disease [10]. \n\n Patients receiving concomitant piperacillin/tazobactam or co-amoxyclavulinic acid \n\n Patients on palliative chemotherapy \n\n Patients with history of allergy to triazoles \n\n Patients with prior history of anaphylactic reaction to conventional amphotericin B \n\n Patients with serum levels of aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, or bilirubin more than 5 times the upper limit of normal or renal impairment with calculated creatinine clearance < 30ml/min \n\n Patients with expected life-expectancy < 72 hours", - "brief_summary": "Chemotherapy lowers the white blood cell count or weakens the immune system for a long time. This puts the patients at a high risk of getting a serious fungal infection of the internal organs or blood. One of these infections is caused by a mold called Aspergillus and can be life threatening. Usually doctors give preventive antifungal therapy to try to lower the risk of this infection. Despite this, patients are still at risk of getting fungal infection. This study is thus designed to test Galactomannan - a component of cell wall of Aspergillus and hence detect and treat fungal infection early.", - "NCTID": "NCT00361517" - }, - { - "brief_title": "Evaluation of Bronchial Inflammation in Allergic Bronchopulmonary Aspergillosis (ABPA)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cystic Fibrosis,']", - "diseases_list": [ - "Cystic Fibrosis," - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n informed consent \n\n age between 4 and 45 years \n\n well-known Cystic fibrosis \n\n Lung function: FEV1 (% pred.) \u2265 70% \n\n ", - "exclusion_criteria": ": \n\n age < 4 and > 45 years \n\n lung function: FEV1 (% pred.)< 70% \n\n other chronic diseases or infections (e.g., HIV, tuberculosis, malignancy) \n\n pregnancy \n\n known alcohol, drug and/or drug abuse \n\n inability to capture the scale and scope of the study \n\n participation in another study", - "brief_summary": "Chronic bronchial inflammation is an important clinical feature in cystic fibrosis. Approximately 10% of patients with cystic fibrosis suffer from Allergic Bronchopulmonary Aspergillosis. In addition airway inflammation in patients with cystic fibrosis (CF) plays a major role in progression of CF lung disease. In patients with mild disease (Vital capacity >75%) airway inflammation is often under diagnosed.~Severity of allergy against Aspergillus fumigatus will be examined using radioallergosorbent test and skin Prick-test. Subsequently, in patients with established sensitization (RAST \u2265 0.35 IU/mL) a specific bronchial provocation with Aspergillus will be performed. In addition, exhaled nitric oxide,carbon monoxide, exhaled air temperature and inflammatory cells in sputum is measured. 24 hours after bronchial allergen provocation, exhaled NO, CO, air temperature, and bronchial responsiveness is determined and a second sputum obtained.~This study is designed to characterize patients with CF and sensitization against Aspergillus fumigatus in an early stage to prevent pulmonary complications of ABPA. In addition sputum cytokine profiles in CF patients with mild and moderate disease may be different in patients without and with involvement of small airway disease (SAD).", - "NCTID": "NCT00906568" - }, - { - "brief_title": "Aspergillus PCR Early Detection in High Risk Oncohematological Patients", - "phase": "", - "drugs": "['Aspergillus PCR technique', 'Aspergillus AGA technique']", - "drugs_list": [ - "Aspergillus PCR technique", - "Aspergillus AGA technique" - ], - "diseases": "['Infections']", - "diseases_list": [ - "Infections" - ], - "enrollment": "225.0", - "inclusion_criteria": "inclusion criteria: \n\n Signature of informed consent to participate in the study. \n\n Adult patients (> 18 years), diagnosed with acute myelogenous leukemia or myelodysplastic syndrome with chemotherapy (CT) intensive, or admitted to undergo allogeneic hematopoietic progenitor cells, or transplantation with graft versus host disease. \n\n The patient should be included in this protocol from the start of their chemotherapy or conditioning therapy as reflected in another section. \n\n ", - "exclusion_criteria": ": \n\n Employment of antifungal prophylaxis (30 days prior to inclusion) with triazole / polyene with activity against Aspergillus (itraconazole, voriconazole, posaconazole, amphotericin B inhalation). \n\n Use of other systemic antifungal activity against Aspergillus (amphotericin, terbinafine, flucytosine, echinocandins, etc.). Therefore it will Fluconazole prophylaxis exclusively. \n\n Background of IFI proven / probable prior \n\n Probable IFI / tested at the time of inclusion in the study. \n\n Exclusion will cause a lack of compliance with the inclusion criteria. \n\n Patients who have a lack of follow biweekly with galactomannan or PCR. Have a bacterial infection not properly treated and controlled before starting empirical antifungal treatment (according to the definition given above). And finally they have a neutropenia of short duration that it creates a significant risk of IFI. This information will not be known logically to include the patient in the study.", - "brief_summary": "ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION", - "NCTID": "NCT01742026" - }, - { - "brief_title": "Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis", - "phase": "Phase 4", - "drugs": "['Itraconazole']", - "drugs_list": [ - "Itraconazole" - ], - "diseases": "['Cystic Fibrosis']", - "diseases_list": [ - "Cystic Fibrosis" - ], - "enrollment": "35.0", - "inclusion_criteria": "inclusion criteria \n\n Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride greater than 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations \n\n Patient must be known to be chronically colonized with Aspergillus fumigatus. \n\n Patients must be clinically stable at randomization, no use of new inhaled, oral or intravenous antibiotics or oral or intravenous corticosteroids during the 14-day period prior to randomization. \n\n 6 years of age and older \n\n Patients must weigh at least 20 kg \n\n Post-menarche females must be using an effective form of contraception. \n\n ", - "exclusion_criteria": " \n\n Inability to give informed consent. \n\n Respiratory culture positive for B.cepacia complex \n\n Renal function abnormalities-Creatinine greater than 1.5 times upper limit of normal within a 30 day period prior to randomization \n\n Liver function abnormalities : AST or ALT greater or equal to 2.5 times the upper limit of normal within a 30 day period prior to randomization \n\n Neutropenia, absolute neutrophil count< or = 1000 within a 3-day period prior to randomization \n\n History of biliary cirrhosis documented by liver biopsy or imaging. \n\n History of portal hypertension. \n\n Investigational drug use within 30 days of randomization date. \n\n History of alcohol, illicit drug or medication abuse within 1 year of randomization. \n\n Women who are pregnant, breastfeeding or trying to conceive", - "brief_summary": "This clinical trial will attempt to determine whether we can improve clinical outcomes for patients with cystic fibrosis who are infected with a fungus called Aspergillus fumigatus.", - "NCTID": "NCT00528190" - }, - { - "brief_title": "Study Safety/Efficacy of AmBisome Loading Dose Regimen Versus Standard AmBisome Regimen for Initial Treatment", - "phase": "Phase 3", - "drugs": "['AmBisome']", - "drugs_list": [ - "AmBisome" - ], - "diseases": "['Invasive Aspergillosis', 'Other Fungal Infections']", - "diseases_list": [ - "Invasive Aspergillosis", - "Other Fungal Infections" - ], - "enrollment": "800.0", - "inclusion_criteria": "inclusion criteria: \n\n Immunocompromised due to hematologic malignancies, chemotherapy-induced neutropenia, hematopoietic stem cell transplantation, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy (greater than or less than 20 mg of Prednisone or equivalent for greater than or less than 3 weeks), treatment with other immunosuppressant medications, or other acquired or hereditary immunocompromising conditions that place the patients at risk for IFI. Evidence of Proven, Probably or Possible IFFI by modified EORTC criteria. Continued treatment with study drug is contingent upon confirmation of diagnosis of Proven or Probable IFI within 4 working days after study entry. \n\n ", - "exclusion_criteria": ": \n\n Life expectancy of less than 30 days; chronic IFI (defined as signs/symptoms of IFI present for less 4 weeks preceding entry into study;prior systemic therapy of greater than or less than 4 days with any polyene anti-fungal agent within 14 days of study enrollment;prior systemic therapy of greater than or less than 4 days with non-polyenes for the current, documented IFI. Use of another investigational, unlicensed drug within 30 days of screening or concurrent participation in another clinical trial using an investigational, unlicensed drug; serum creatinine greater than 2 x upper limit of normal (ULN), serum ALT or AST less than 5 x ULN; pregnant or lactating women; history of allergy or serious adverse reaction to any polyene anti-fungal agent.", - "brief_summary": "To evaluate and compare two AmBisome dosing regimens for the initial treatment of invasive aspergillosis and other filamentous fungal infections diagnosed by modified EORTC criteria in immunocompromised patients, as determined by overall response rates at end of course of treatment.", - "NCTID": "NCT00158730" - }, - { - "brief_title": "NexGen EBA Radiologic and Immunologic Biomarkers of Sterilizing Drug Activity in Tuberculosis", - "phase": "Phase 2", - "drugs": "['Treatment', 'PET/CT Scan', 'Sample Collection']", - "drugs_list": [ - "Treatment", - "PET/CT Scan", - "Sample Collection" - ], - "diseases": "['Pulmonary Tuberculosis']", - "diseases_list": [ - "Pulmonary Tuberculosis" - ], - "enrollment": "262.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 to 65 years with body weight from 30 kg to 90 kg \n\n Sputum acid-fast bacilli (AFB) smear positive (at least 1+ on the WHO International Union Against Tuberculosis and Lung Disease scale) \n\n Likely able to produce approximately 10 mL of sputum per day \n\n Xpert MTB/RIF-confirmed M.tb \n\n Rifampin-sensitive pulmonary tuberculosis as indicated by Xpert MTB/RIF \n\n ALT <3X upper limit of normal, creatinine <2X upper limit of normal \n\n Willingness to have samples stored \n\n ", - "exclusion_criteria": ": \n\n Clinically suspected disseminated TB or acuity of illness too much as deemed by clinicians \n\n Has been treated for tuberculosis within the past 3 years \n\n Treatment with agents known to have anti-tuberculosis activity (e.g., fluoroquinolones, linezolid) for any indications during the current episode of clinical illness or within 2 months prior to screening, whichever is longer \n\n Cirrhosis or chronic kidney disease \n\n Disease complications or concomitant illness that might compromise safety or the interpretation of trial endpoints, such as known diagnosis of chronic inflammatory condition (e.g., sarcoidosis, rheumatoid arthritis, and connective tissue disorder) \n\n Use of immunosuppressive medications, such as TNF-alpha inhibitors or systemic or inhaled corticosteroids, within 2 weeks prior to screening \n\n Subjects with diabetes, point of care HbA1c above 6.5, or random glucose over 200 mg/dL \n\n Conditions which compromise the subject s ability to take or absorb oral drugs \n\n Normal PA-Chest radiograph, determined during screening \n\n Total lung (left or right) collapse on PA-Chest radiograph \n\n HIV positive \n\n Pregnant or breastfeeding \n\n Any other condition that, in the responsible clinician s judgment, renders a subject too sick to safely tolerate 2 weeks study therapy \n\n Any condition that constitutes a contraindication to any of the drugs to be used on any study arms", - "brief_summary": "Background:~- Tuberculosis (TB) is a lung infection caused by bacteria. When people with TB cough, they may spread these bacteria. Researchers are looking for new TB medicines. They want to find a faster way to tell if a drug might combat TB.~Objective:~- To learn the effect of different anti-TB drugs on microbiological, radiographic and immunologic markers in people with TB.~Eligibility:~- Adults age 18-65 who weigh 30-90 kg and have common TB bacteria that can be treated with common TB medicines.~Design:~Participants will be admitted to the hospital for screening. They will have medical history, physical exam, and chest radiograph. They will give blood, urine, and sputum samples.~Participants will be put in 1 of 8 groups.~Participants will get one or a combination of TB medicines daily for about 14 days.~Each day, participants:~Will discuss side effects.~May have a physical exam.~Will spit mucus into a cup. They may breathe in saline water through a nebulizer to make them cough.~Participants will have blood taken 3-4 times during the study~Participants will have 2-3 Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG-PET/CT) scans. FDG is a radioactive sugar molecule which helps measure TB disease in the lungs. It will be injected into a vein. Participants will lie in a scanner that takes pictures.~Around study day 14, participants will leave the hospital. They will be referred to a local TB clinic. There they will get the standard 4 TB medicines. Those in group 8 will already be on these medicines and will have another FDG-PET/CT on day 28.~Participants will be in the study for up to 28 days.", - "NCTID": "NCT02371681" - }, - { - "brief_title": "Open-label Vitamin D Trial for Patients With Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis", - "phase": "", - "drugs": "['cholecalciferol (Vitamin D3)']", - "drugs_list": [ - "cholecalciferol (Vitamin D3)" - ], - "diseases": "['Cystic Fibrosis', 'Allergic Bronchopulmonary Aspergillosis']", - "diseases_list": [ - "Cystic Fibrosis", - "Allergic Bronchopulmonary Aspergillosis" - ], - "enrollment": "7.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female \u2265 12 years of age at enrollment \n\n Confirmed diagnosis of CF based on the following criteria: \n\n One or more clinical features consistent with the CF phenotype AND (b or c) \n\n Positive sweat chloride > 60 mEq/liter (by pilocarpine iontophoresis) \n\n two identifiable mutations consistent with CF \n\n Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. \n\n Clinically stable at enrollment as assessed by the site investigator \n\n Past or present respiratory culture positive for Aspergillus fumigatus \n\n IgE \u2265 250 and/or presence of class II or higher aspergillus specific IgE on enrollment \n\n Ability to comply with medication use, study visits and study procedures as judged by the site investigator - \n\n ", - "exclusion_criteria": ": \n\n 1. Systemic corticosteroids (1 mg/kg if < 20 kg or > 20 mg of prednisone per day),. \n\n 2. Investigational drug use within 30 days of screening 3. Laboratory abnormalities at screening \n\n a. Serum Calcium > 11 mg/dl b. 25(OH) D > 50 ng/ml at screening. c. Creatinine \u2265 1.5, or estimated GFR <60 by Cockcroft-Gault or MDRD equation. d. LFT\u2265 3xULN \n\n 4. History of transplantation or currently on lung transplant list 5. Positive serum pregnancy test at screening (to be performed on all post-menarche females) 6. Pregnant, breastfeeding, or if post-menarche female, unwilling to practice birth control during participation in the study 7. Presence of a condition or abnormality that in the opinion of the site investigator would compromise the safety of the subject or the quality of the data 8. Diagnosis of HIV and a CD4+ T cell count below 500 cells/ml or active hepatitis B or C infection. \n\n 9. Undergoing therapy for non-tuberculous mycobacterial infection", - "brief_summary": "The purpose of this study is to see if giving people with CF and ABPA enough vitamin D to make their blood levels of the vitamin higher, will reduce the allergic response in their body and make the symptoms caused by ABPA better.", - "NCTID": "NCT01222273" - }, - { - "brief_title": "Detection of Aspergillus Fumigatus and Sensitization in COPD Patients With Bronchiectasis vs Without Bronchiectasis", - "phase": "", - "drugs": "['Sputum induction', 'Skin prick test', 'Questionnaires']", - "drugs_list": [ - "Sputum induction", - "Skin prick test", - "Questionnaires" - ], - "diseases": "['Chronic Obstructive Pulmonary Disease']", - "diseases_list": [ - "Chronic Obstructive Pulmonary Disease" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Established diagnosis of COPD by medical doctor (based on clinical history or pulmonary function test) \n\n Smoking history of at least 10 pack-years \n\n CT Thorax available for assessment of bronchiectasis \n\n FEV1 >= 30% \n\n ", - "exclusion_criteria": ": \n\n Mechanical or non-invasive ventilation \n\n Other main respiratory diagnosis other than COPD \n\n Active mycobacterial disease \n\n Immunosuppression other than steroids \n\n Active cancer treatment", - "brief_summary": "A single center case-control study with 100 COPD patients will be organized to compare patients with and without bronchiectasis with regard to the presence of Aspergillus in sputum samples, Aspergillus sensitization and vitamin D. Induced sputum samples will be optimized for culture, Aspergillus galatomannan analysis and RT-PCR.~This study is part of a larger project in which we assume that chronic respiratory infection by Aspergillus fumigatus and the accompanying immune response play an important role in the development of bronchiectasis in COPD. We suspect that this mechanism is controlled by vitamin D and it fails by suppression of the vitamin D receptor by Aspergillus fumigatus.~The present study is designed by the Laboratory of pneumology and will be conducted in collaboration with the Laboratory of clinical bacteriology and mycology of the Catholic University of Leuven.", - "NCTID": "NCT02332122" - }, - { - "brief_title": "Analysis T Cells Response for Identification of Aspergillus Bronchitis With Cystic Fibrosis Patients", - "phase": "", - "drugs": "['T specific response for diagnostic of aspergillus bronchitis']", - "drugs_list": [ - "T specific response for diagnostic of aspergillus bronchitis" - ], - "diseases": "['Cystic Fibrosis Patient', 'Patient Without Treatment Against A.Fumigatus']", - "diseases_list": [ - "Cystic Fibrosis Patient", - "Patient Without Treatment Against A.Fumigatus" - ], - "enrollment": "68.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient with cystic fibrosis followed at Resource Centers and Cystic Fibrosis Skills (CRCM) Montpellier \n\n Patient aged 15 or over \n\n Patient able to understand the nature, purpose and methodology of the study. \n\n Patient and his legal representative for minors who have given their free and informed consent \n\n Affiliate or beneficiary of a social security scheme. \n\n ", - "exclusion_criteria": ": \n\n Patients on antifungal treatment at the time of sampling \n\n Pregnant or breastfeeding \n\n Major protected by law (guardianship, curator or under Backup Justice) \n\n Inability to understand the nature and goals of the study and / or communication difficulties with the investigator \n\n Subject attending another search including a period of exclusion still going to run-in", - "brief_summary": "The study aims to asses the ability of cell tests based on the analysis of the anti-Aspergillus cell responses and identify Aspergillus bronchitis with patients with cystic fibrosis.~In addition, the study will evaluate the contribution of biological classification of aspergillosis according to criteria recently proposed by Baxter et al. compared to the classification used in clinical practice in the hospital of Montpellier.", - "NCTID": "NCT02550041" - }, - { - "brief_title": "Safety and Efficacy Study of Inhaled AmBisome for Prevention of Aspergillus Colonization in Lung Transplant Recipients", - "phase": "Phase 2", - "drugs": "['Ambisome \u00ae', 'Regular standard of care medication']", - "drugs_list": [ - "Ambisome \u00ae", - "Regular standard of care medication" - ], - "diseases": "['Lung Transplant Recipient']", - "diseases_list": [ - "Lung Transplant Recipient" - ], - "enrollment": "4.0", - "inclusion_criteria": "inclusion criteria: \n\n Single or double lung transplant recipients who are at least one year out of transplantation. \n\n Age >18yrs of age \n\n Able to understand and complete informed consent. \n\n ", - "exclusion_criteria": ": \n\n Pregnant woman or woman capable of bearing children, who will not perform urine pregnancy test. \n\n Nursing mothers. \n\n Subjects with hypersensitivity to Amphotericin deoxycholate or liposomal Amphotericin. \n\n Subjects with a past history of bronchospasm associated with aerosol drug use. \n\n Subjects with active bacterial or viral infection as defined by the current use of non-prophylactic antibiotic anti-viral medications. \n\n Subjects treated with cytolytic medications (Campath /Thymoglobulin) within the last month. \n\n Subjects with an FEV1< 30% Predicted or FVC% <30%. \n\n Subjects requiring supplemental oxygen. \n\n Receipt of Inhaled or IV Amphotericin B within last 30 days. \n\n Subjects with known fungal infection as per MSG Criteria on therapy with antifungal drugs or diagnosed on the day of bronchoscopy. \n\n Current use of azoles active against molds (Voriconazole, itraconazole, posaconazole) for the prophylaxis. \n\n Serum creatinine > 150 mmol/L on the day of clinic visit. \n\n Liver enzymes ALT/ AST/ Alkphos greater than two times upper limit of normal. \n\n Concurrent intravenous aminoglycoside use. \n\n Subjects with fever > 38.2\u00b0C. \n\n Subjects on mechanical ventilation. \n\n Expected survival less than 6 months. \n\n Re-transplants and heart/lung transplant patients.", - "brief_summary": "Lung transplant recipients have the highest rate of Invasive Aspergillus (IA)infection among solid organ transplant recipients. The most important risk factor for the development of IA (which is associated with disease and death) is colonization of the organism in the respiratory tract.~Azoles are used to prevent the development of IA. Puffers containing antifungal medication can be used to treat the lungs without the need to worry about the medication interactions & side-effects in the blood. An example of this is the aerosolized amphotericin B. Its use is limited by the patients' tolerating this medication that may cause cough, nausea & contraction of the air pathways.~The lipid preparation is better tolerated and has longer dosing interval than inhaled amphotericin B. The investigators propose a pilot study to determine the long-term safety of inhaled AmBisome administration of drug and generate the preliminary data on the effectiveness of this drug to prevent aspergillus colonization.", - "NCTID": "NCT01254708" - }, - { - "brief_title": "The Immune Tolerance Mechanism Induced by IL-17-producing Regulatory T Cells in the Orthotopic Liver Transplant Recipients With Aspergillosis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Liver Transplantation', 'Aspergillus', 'Interleukin-17', 'Treg Cell', 'Immune Tolerance']", - "diseases_list": [ - "Liver Transplantation", - "Aspergillus", - "Interleukin-17", - "Treg Cell", - "Immune Tolerance" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Liver transplantation patients \n\n ", - "exclusion_criteria": ": \n\n Psychopath", - "brief_summary": "Infection accounted for the first cause of death in patients after liver transplantation, and 2 / 3 of the cause of death was fungal infections. The investigators group early found that T cell subsets playing a role of inducing immune tolerance were significantly increased in vivo of liver transplantation patients with aspergillus infection, which may be a kind of Treg cells expressing IL-17. To explore the immune tolerance mechanism induced by the immune balance cells is important to liver transplantation patients for improving efficacy and reducing the mortality. Therefore, the investigators are going to get the blood sample and liver tissue of the liver transplantation patients before and after treatment of aspergillus infection, flow cytometry analysis of blood T cell subsets, Cytometric Bead Array to detect changes in blood cytokines, laser capture microdissection to obtain liver biopsies of inflammatory cells in portal area and further for analysis of T cell subsets and protein. And the investigators are also to investigate the characteristics of CCR6 + CD4 + FOXP3 + Treg cell clones secreting IL-17 and the capacity of which suppressing conventional T cell proliferation. This study may find new methods, such as certain types of T cell subsets or cytokines for the treatment of liver transplant patients, which not only to anti-rejection but also to reduce fungal infection.", - "NCTID": "NCT01117077" - }, - { - "brief_title": "Cross-sectional Characterization of Idiopathic Bronchiectasis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Infection', 'Bronchial Diseases', 'Respiratory Tract Diseases']", - "diseases_list": [ - "Infection", - "Bronchial Diseases", - "Respiratory Tract Diseases" - ], - "enrollment": "275.0", - "inclusion_criteria": "inclusion criteria: \n\n The criteria for participants to enter the study mandates that each patient have received a standard (current clinical practice) diagnostic evaluation that includes a CT scan of the chest to document bronchiectasis, prior to enrolling in the Consortium study. To enter this protocol, adults must have bronchiectasis and meet the following criteria: \n\n Males or females, age greater than or equal to18 years \n\n Chronic cough \n\n An available CT of the chest (on a CD) that shows evidence of dilated airways fulfilling radiographic criteria for bronchiectasis in more than one lobe \n\n Ability to provide informed consent, including HIPAA consent \n\n ", - "exclusion_criteria": ": \n\n A participant should not be in the study if they have not had a standard clinical evaluation to rule out other potential causes of chronic sino-pulmonary disease. \n\n Known diagnosis of cystic fibrosis with classic clinical presentation and elevated sweat chloride levels and/or two known disease-causing CFTR mutations \n\n History of tuberculosis or other known explanation for bronchiectasis, such as alpha 1-antitrypsin deficiency (ZZ or ZS), confirmed or probable PCD, inflammatory bowel disease, rheumatoid arthritis, Sjogren s syndrome, allergic bronchopulmonary aspergillosis, or documented primary or acquired immunodeficiency \n\n Current smoker or > 10 pack-year history of tobacco use \n\n Prior solid organ transplant", - "brief_summary": "Background:~- Bronchiectasis is a type of lung condition in which the lungs airways are abnormally stretched and widened. This stretching and widening makes it difficult for mucus and other substances to move out of the lungs, encouraging the growth of bacteria and leading to breathing problems or infection. Bronchiectasis can be caused by genetic disorders or diseases such as tuberculosis or rheumatoid arthritis. Researchers are interested in developing better ways to diagnose and treat a lung problem called idiopathic or unexplained bronchiectasis.~Objectives:~- To better describe the physical characteristics, radiographic patterns, and airway microbiology of unexplained bronchiectasis and to look for possible genetic links or risk factors.~Eligibility:~Individuals at least 18 years of age who have a chronic cough and who have had a CT scan that has revealed signs of bronchiectasis.~Current smokers or those who have smoked for at least 10 years, as well as individuals who have known causes of bronchiectasis or who have had organ transplants, are not eligible to participate.~Design:~Participants will have one outpatient clinic visit for evaluation with a physical examination including detailed body size measurements and medical history and for collection of blood samples for routine lab tests and genetic analyses and a chest x-ray if no recent one is available.~Participants will also have tests of lung function, and measurement of a gas called nitric oxide in the nose. Participants whose initial tests show abnormal results may also be asked to have a nasal scrape to collect cell samples and/or a skin sweat test to measure salt concentrations.~Participants will also have a sputum specimen collected during the visit and will be asked to collect two additional early morning sputum samples and a mouth rinse at home within 2 weeks of the clinic visit, and mail the sample collection materials to the research team.", - "NCTID": "NCT01264055" - }, - { - "brief_title": "Preliminary Study of Dornase Alfa to Treat Chest Infections Post Lung Transplant.", - "phase": "Phase 2", - "drugs": "['Dornase Alfa', 'Isotonic Saline.']", - "drugs_list": [ - "Dornase Alfa", - "Isotonic Saline." - ], - "diseases": "['Lung Transplant Infection', 'Lower Respiratory Tract Infection']", - "diseases_list": [ - "Lung Transplant Infection", - "Lower Respiratory Tract Infection" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n Post bilateral sequential lung transplant \n\n Capable of performing airway clearance techniques / nebulisers \n\n Pulmonary exacerbation as defined by Fuchs et al \n\n Must be productive of sputum \n\n Able to provide informed consent within 48 hours of presentation. \n\n *Fuchs Scale(8): Treatment with / without parenteral antibiotics for 4/12 signs and symptoms: \n\n Change in sputum \n\n New or increased haemoptysis \n\n Increased cough \n\n Increased dyspnoea \n\n Malaise, fever or lethargy \n\n Temp above 38 \n\n Anorexia or weight loss \n\n Sinus pain or tenderness \n\n Change in sinus discharge \n\n Change in physical examination of the chest \n\n Radiographic changes indicative of pulmonary infection \n\n Decrease in pulmonary function by 10 % or more \n\n ", - "exclusion_criteria": ": \n\n Paediatric transplant <18yrs \n\n Single lung transplant - native lung physiology may confound outcome measures \n\n Interstate - unable to complete follow up \n\n Unable to perform lung function testing \n\n Unable to complete subjective outcome measures- unable to read English fluently \n\n Critically unwell / intensive care unit / ventilator dependent \n\n Within 2 months of transplant date *Cystic Fibrosis will be stratified", - "brief_summary": "Patients who have undergone lung transplantation are at an increased risk of developing chest infections due to long-term medication suppressing the immune response. In other chronic lung diseases such as cystic fibrosis (CF) and bronchiectasis, inhaled, nebulised mucolytic medication such as dornase alfa and isotonic saline are often used as part of the management of lung disease characterized by increased or retained secretions. These agents act by making it easier to clear airway secretions, and are currently being used on a case-by-case basis post lung transplantation.~To the investigators knowledge, these agents have not been evaluated via robust scientific investigation when used post lung transplant, yet are widely used in routine practice. Patients post lung transplant must be investigated separately as they exhibit differences in physiology that make the clearance of sputum potentially more difficult when compared to other lung diseases. Lower respiratory tract infections are a leading cause of hospital re-admission post lung transplant. Therefore, this highlights the need for a randomized controlled trial. The aim of this study is to assess the efficacy of dornase alfa, compared to isotonic saline, in the management of lower respiratory tract infections post lung transplant. Investigators hypothesize that dornase alfa will be more effective than isotonic saline.~The effect of a daily dose of dornase alfa and isotonic saline will be compared over a treatment period of 1 month. Patients admitted to hospital suffering from chest infections characterized by sputum production post lung transplant will be eligible for study inclusion. Patients will be followed up through to 3 months in total to analyze short-medium term lasting effect. Investigators wish to monitor physiological change within the lung non-invasively via lung function analysis whilst assessing patient perceived benefit via cough specific quality of life questionnaires. These measures will be taken at study inclusion and repeated after 1 month and 3 months. Day to day monitoring will be performed via patient symptom diaries, incorporating hospital length of stay and exacerbation rate. The outcomes of this study have the potential to guide clinical decision-making and highlight safe and efficacious therapies.", - "NCTID": "NCT01952470" - }, - { - "brief_title": "Ventilator Associated Pneumonia in Taper Guard Versus Normal Tube in ICU Patients", - "phase": "Phase 4", - "drugs": "['Taper Guard Endotracheal Tube', 'Conventional endotracheal tube']", - "drugs_list": [ - "Taper Guard Endotracheal Tube", - "Conventional endotracheal tube" - ], - "diseases": "['Ventilator Associated Pneumonia']", - "diseases_list": [ - "Ventilator Associated Pneumonia" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n All adult patients above 18 years old admitted into the Intensive Care unit and who is to be intubated and likely to receive more than 72 hours of ventilation would be admitted into the trial \n\n ", - "exclusion_criteria": ": \n\n presence of cavitary lung disease based on chest x-ray findings, \n\n primary lung cancer or another metastatic malignancy to the lungs, or known or suspected viral or fungal etiology, \n\n pneumocystis carinii pneumonia, \n\n legionella OR Mycoplasma pneumonia or active tuberculosis.", - "brief_summary": "Ventilator associated pneumonia ( VAP) adds burden to the care of the intensive care patients as they may cause the death of the patient or prolong the intensive care stay or complicate the illness in other ways. The risk of infection is dependent on the interplay between bacteria load into the lungs and the immune status. There has been a lot of focus on bacteria load reduction and this includes the use of subglottic suctioning in an attempt to reduce the amount of bacteria that may move into the lungs. The Hi Lo tubes which were designed to allow subglottic suctioning was significantly effective in reducing the incidence of ventilator associated pneumonia compared to normal tubes. A new generation of endotracheal tubes that not only incorporate subglottic suctioning but provide a more snug fit into the tracheal by a new tapering design may be even more useful to provide the solution for bacterial load reduction. Conventional tubes which may furrow on themselves to allow the creation of microchannels may aid microaspiration. The taper guard which has facilities for subglottic suctioning as well as the strategy to reduce furrowing to the minimum may be the answer to the problem of ventilator associated pneumonia. This study is to determine the extent of protection this tube has against ventilator associated pneumonia compared with conventional endotracheal tubes", - "NCTID": "NCT01501227" - }, - { - "brief_title": "Immune Reconstitution in Tuberculosis Disease", - "phase": "Phase 2", - "drugs": "['vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)', 'Placebo tablets']", - "drugs_list": [ - "vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)", - "Placebo tablets" - ], - "diseases": "['Pulmonary Tuberculosis (TB)']", - "diseases_list": [ - "Pulmonary Tuberculosis (TB)" - ], - "enrollment": "390.0", - "inclusion_criteria": "inclusion criteria: \n\n HIV negative patients, adult patients >18 years who has not started anti-TB therapy. \n\n Newly diagnosed pulmonary TB confirmed by microscopy or culture but also sputum-negative clinical TB cases (defined according to the WHO 2006 criteria for sputum smear-negative TB ie. clinical symptoms of TB, chest X-ray findings and response to standard treatment). \n\n ", - "exclusion_criteria": ": \n\n Patients who have already started treatment with anti-TB drugs for more that 5 days. \n\n HIV-positive patients. \n\n History of anti-TB treatment in the past 2 years. \n\n Local extra-pulmonary TB in the absence of lung manifestations. \n\n Hypercalcaemia (serum calcium > 3 mmol/L) identified at baseline. \n\n Pregnant and breast feeding women. \n\n Any known liver or kidney function abnormality, malignancy or patients treated with cardiac glycosides.", - "brief_summary": "The aim with study is to provide adjunctive therapy with vitamin D and phenylbutyrate together with standard anti-tuberculosis treatment to significantly improve clinical recovery among patients with untreated, active pulmonary tuberculosis.", - "NCTID": "NCT01698476" - }, - { - "brief_title": "An Open Cohort of Childhood Tuberculosis in Mbarara National Referral Hospital, Uganda", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Tuberculosis']", - "diseases_list": [ - "Tuberculosis" - ], - "enrollment": "396.0", - "inclusion_criteria": "inclusion criteria: \n\n Any child with at least one of the following criteria: \n\n Unexplained weight loss or documented failure to thrive or stagnant weight or Growth faltering on the growth charts over the past 3 months despite adequate nutrition and deworming, \n\n Non - remittent cough or wheeze for more than 2 weeks, \n\n Night sweats persistent or intermittent during the last 2 weeks \n\n Prolonged fever (temperature > 38\u00b0C) for 7 days, after common causes such malaria or pneumonia has been excluded. \n\n Wheeze/Stridor - persistent, non remitting during the last 2 weeks \n\n Chest pain - Persistent, localized, pleuritic in nature during the last 2 weeks \n\n Unexplained fatigue, weakness, apathy, lethargy or reduced playfulness during the last 2 weeks \n\n Painless superficial lymph node mass (>2x2cm)- \n\n Chronic onset meningitis (>5days), lymphocytic predominance in CSF or meningitis not responding to antibiotic treatment (ref 8) \n\n Recent gibbus \n\n Abdominal distention with ascites OR \n\n Any child with an abnormal chest X-ray (CXR) suggestive of TB (hilar/paratracheal adenopathy with/without airway compression, airspace opacification not responding to antibiotics or documented TB contact, lung cavities or miliary infiltrates) OR \n\n Asymptomatic child with a history of recent contact (within past year) with a pulmonary TB smear or culture positive patient and an abnormal chest X-ray AND \n\n Informed Consent signed by parent or legal representative \n\n ", - "exclusion_criteria": ": \n\n Current TB treatment (patient who received < 3 days of treatment or patients receiving IPT could be still included) or TB treatment completed within the past 6 months. \n\n Absence of informed consent \n\n Living outside of Greater Mbarara region. \n\n Unable or unwilling to attend to the follow-up visits", - "brief_summary": "The aims at investigating how the diagnosis of Tuberculosis in children in a setting of high TB and HIV prevalence can be improved and to assess the treatment outcomes and tolerance of the new WHO recommended TB drug dosages.", - "NCTID": "NCT01422798" - }, - { - "brief_title": "Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection", - "phase": "Phase 3", - "drugs": "['RPT + INH once weekly for 3 months given by DOT', 'Isoniazid (INH) daily for 9 months']", - "drugs_list": [ - "RPT + INH once weekly for 3 months given by DOT", - "Isoniazid (INH) daily for 9 months" - ], - "diseases": "['Tuberculosis']", - "diseases_list": [ - "Tuberculosis" - ], - "enrollment": "8053.0", - "inclusion_criteria": "inclusion criteria: \n\n Males or nonpregnant, non-nursing females > 2 years old. \n\n Tuberculin (PPD) skin test reactors at high risk for developing TB but without evidence of active TB. High-risk reactors are defined as: \n\n Household and other close contacts of persons with culture-confirmed TB who are TST-positive as part of a contact investigation conducted within two years of the date of enrollment. Close contact is defined as > 4 hours in a shared airspace during a one-week period. Among close contacts, a positive TST is defined as > 5 mm induration after 5 TU of PPD placed intradermally using the Mantoux technique. \n\n TST converters--converting from a documented negative to positive TST within a two-year period. This is defined as persons with a tuberculin skin test of > 10 mm within two years of a nonreactive test or persons with an increase of > 10 mm within a two-year period. \n\n HIV-seropositive, TST positive (> 5 mm induration) persons. \n\n Persons with > 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray, no prior history of TB treatment, > 5 mm induration on TST, and 3 sputum cultures negative for M. tuberculosis on final report. \n\n HIV-seropositive close contacts of persons with culture-confirmed TB, regardless of TST status. In addition, HIV-seropositive close contacts of persons with culture-confirmed TB who have a documented history of completing an adequate course of treatment for active TB or latent TB infection, are also eligible. \n\n Willing to provide signed informed consent, or parental consent and participant assent. \n\n ", - "exclusion_criteria": ": \n\n Current confirmed culture-positive or clinical TB \n\n Suspected TB (as defined by the site investigator) \n\n Tuberculosis resistant to isoniazid or rifampin in the source case \n\n A history of treatment for > 14 consecutive days with a rifamycin or > 30 consecutive days with INH during the previous 2 years. \n\n A documented history of a completing an adequate course of treatment for active TB or latent TB infection in a person who is HIV-seronegative. \n\n History of sensitivity/intolerance to isoniazid or rifamycins \n\n Serum aminotransferase aspartate (AST, SGOT) > 5x upper limit of normal among persons in whom AST is determined \n\n Pregnant or nursing females \n\n Persons currently receiving or planning to receive HIV-1 protease inhibitors or nonnucleoside reverse transcriptase inhibitors in the first 90 days after enrollment. \n\n Weight < 10.0 kg", - "brief_summary": "Open-label, multi-center, Phase III clinical trial to compare the effectiveness and tolerability of a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) to the effectiveness of a nine-month (270-dose)regimen of daily isoniazid (9INH) to prevent tuberculosis (TB) among high-risk tuberculin skin-test reactors, including children and HIV-infected persons, who require treatment of latent TB infection (LTBI).", - "NCTID": "NCT00023452" - }, - { - "brief_title": "To Assess the Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa", - "phase": "Phase 2", - "drugs": "['adalimumab']", - "drugs_list": [ - "adalimumab" - ], - "diseases": "['Hidradenitis Suppurativa']", - "diseases_list": [ - "Hidradenitis Suppurativa" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects with moderate to severe HS as defined by a HSSI > 8 AND at least ONE of the following: \n\n HS >1 year duration with multiple ER or doctors visits related to HS \n\n Intralesional kenalog injection >5/year, however none within 2 weeks of entry \n\n Failed systemic retinoids, but not within 3 months of entry \n\n Failed at least one prior course of antibiotic therapy, which must not have been administered within 2 weeks of entry to the study (excluding the recommended antibiotic regimen given for evidence of active infection immediately before enrollment) \n\n History of surgery (reconstructive), but not within 3 months of entry \n\n ", - "exclusion_criteria": ": \n\n Women who are pregnant, nursing, or planning pregnancy within 6 months after the last injection (this includes father's who plan on fathering a child within 6 months after their last injection). \n\n Use of other systemic anti-inflammatory medication except NSAIDs and low dose systemic steroids (equal or less than 10 mg daily prednisolone or equivalent). \n\n If found to have an active infection, patients must have completed topical or oral antibiotic therapy at least 7 days before first injection. \n\n Have a known history of serious infections (e.g., hepatitis, pneumonia or pyelonephritis) in the previous 3 months. \n\n Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening. \n\n Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (e.g., nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly. \n\n Have a concomitant diagnosis or history of congestive heart failure. \n\n Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.", - "brief_summary": "The trial is a 12-week phase 2 study. Subjects will be given subcutaneous injections at weeks 0 (160mg), 2 (80mg), and then every other week (40mg) until week 12 in subjects with moderate to severe hidradenitis suppurativa.", - "NCTID": "NCT00827996" - }, - { - "brief_title": "Effect of Supplementary Vitamin D in Patients With Diabetes Mellitus and Pulmonary Tuberculosis", - "phase": "Phase 4", - "drugs": "['Vitamin D', 'Calcium', 'Placebo Vit D', 'Placebo Calcium']", - "drugs_list": [ - "Vitamin D", - "Calcium", - "Placebo Vit D", - "Placebo Calcium" - ], - "diseases": "['Type 2 Diabetes Mellitus', 'Pulmonary Tuberculosis']", - "diseases_list": [ - "Type 2 Diabetes Mellitus", - "Pulmonary Tuberculosis" - ], - "enrollment": "435.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 30 to 60 years \n\n Patients having both TB and type 2 DM \n\n Patients consenting to participate \n\n No history of previous ATT \n\n Plane to have ATT and DM treatment \n\n ", - "exclusion_criteria": ": \n\n Age less than 30 years or greater than 60 years \n\n Pregnant women \n\n Patients having either TB or type 2 DM \n\n Patients refuse to participate \n\n Patients having extra-pulmonary TB or Multi-drug resistant MDR TB or relapse cases \n\n Patients having hepatic or renal diseases or HIV infection \n\n Patients having hypo- or hyper-parathyroidism \n\n Patients on corticosteroids or immunosuppressive or thiazides diuretics or any other drugs known to interfere with vitamin D levels", - "brief_summary": "Pakistan ranks fifth amongst high tuberculosis-(TB) burden countries, where TB persists as a major cause of misery and death. The Diabetes Mellitus-(DM) is also on rise in Pakistan and people suffering from DM are more prone to catch TB as compared to healthy individuals. This concurrence of two outbreaks may further increase the frequency of TB in Pakistan. The TB DM co-occurrence results in various clinical issues as TB in DM patient increases blood glucose, making DM more difficult to treat, while DM raises the risk of treatment failure, relapse and death among TB patients. In addition, both DM and TB usually coexist with micronutrients deficiencies like vitamin D, which has a vital role in immunity, insulin functioning and respiratory health. It has been suggested that the combined supplementation with vitamin D and calcium might be beneficial in improving the glucose metabolism but the current knowledge is very limited. In a resource restrained country with double burden of infectious and non-infectious diseases, an integrated approach with modification of treatment options may benefit in management of these outbreaks.~Therefore, this study aims whether vitamin D and calcium supplementation could influence the recovery in patients with TB of lung and DM.", - "NCTID": "NCT02169570" - }, - { - "brief_title": "Phase I Clinical Human Tolerability Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10", - "phase": "Phase 1", - "drugs": "['ESAT6-CFP10']", - "drugs_list": [ - "ESAT6-CFP10" - ], - "diseases": "['Healthy']", - "diseases_list": [ - "Healthy" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged from 18 to 40 years old, age difference is not more than 10 years old within the same batch of healthy volunteers, the male to female ratio of cases is 1:1. Body mass index should be in the range of 20 to 27 Body Mass Index BMI: weight (Kg)/ height (M2); \n\n Agreed to participate in the test and sign the informed consent; \n\n Subjects should comply with the requirements of the clinical trial protocol and be followed; \n\n Subjects have no history of TB (Tuberculosis)or family history of tuberculosis; \n\n People have no pulmonary tuberculosis or extrapulmonary tuberculosis,respiratory symptom or systemic symptoms; \n\n People have no tuberculosis focus after examination by X-ray chest radiograph and sputum bacilli; \n\n Subjects have no acute or chronic disease, acute infectious diseases, dermatoses or skin allergy caused by various reasons; \n\n Physical condition: have no history of heart, liver, kidney, gastrointestinal tract, nervous system, or metabolic disturbance, etc. ECG, blood pressure, heart rate, respiratory status and lab test indexes including blood, urine, liver and kidney function, etc are all normal within 4 weeks before screening; \n\n No close contacts of tuberculosis; \n\n Subjects have not participated in other clinical drug trials or inoculated against other prophylactic and immune globulin in the nearly 3 months; \n\n Temperature is normal; \n\n Stop smoking, drinking and drinking contains caffeinated. \n\n ", - "exclusion_criteria": ": \n\n Health people have close contacts of TB (Tuberculosis)patients, especially excreter in 3 weeks before selection; \n\n Suffering from any other serious disease, e.g. during cancer treatment, autoimmune disease, progressive atherosclerosis, diabetes accompanied with complications, chronic obstructive pulmonary disease (COPD) needing oxygen therapy, acute or progressive liver or kidney disease, congestive heart failure, etc.; \n\n People have history of allergy, convulsions, epilepsy, cerebropathy, neurological symptoms and signs; \n\n Patients who have impaired or abnormal immune function, e.g. patients treated with immunosuppressor or immunopotentiator, received immunoglobulin preparation or blood products or plasma extraction outside the gastrointestinal tract in 3 months, human immunodeficiency virus or related diseases; \n\n Acute febrile illness and infection; \n\n Taking part in other clinic trials; \n\n Subjects have participated in any other clinical drug trials in 3 months before our clinical tests; \n\n Allergic constitution, e.g. patients have allergic history to two or more kinds of drugs or food, or drug components; \n\n Substance abuse and alcoholics ; \n\n Pregnant or breast feeding women; \n\n Mental or physical disability; \n\n Informed leavers; \n\n Any other cases that may influence the test evaluation.", - "brief_summary": "In the tests, small sample of clinical study about Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 ( Recombination EC Allergen\uff09 healthy adults was carried out.~24 healthy adults were included as study objects, they were randomly divided into four groups of different Recombinant Allergen EC dose (1, 5, 10\u03bcg/mL, maximum tolerated dose 20\u03bcg/mL, 6 person/dose) for single arm intradermal injection.~The main examination items :vital signs (breathing, heart rate, blood pressure, body temperature ) of each volunteer at 15min, 30min, 1h, 2h, 4h, 8h, 24h, 48h, 72h, 96h after injection, skin reactivity (redness and/or induration) diameter of injection sites,local reaction ( rash, pain, itching, and skin and mucous membranes ) ,a variety of adverse events,routine blood,routine urine, liver and kidney function, ECG and chest X-ray films before and 7 days after intradermal injection .~Preliminary evaluation of safety and tolerability of Recombinant Allergen EC applied in humans, which can provide a safe dosage range for phase II clinical study.", - "NCTID": "NCT01999231" - }, - { - "brief_title": "Comparing Daily vs Intermittent Regimen of ATT in HIV With Pulmonary Tuberculosis", - "phase": "Phase 3", - "drugs": "['ATT (Ethambutol, Pyrazinamide, INH, Rifampicin)']", - "drugs_list": [ - "ATT (Ethambutol", - "Pyrazinamide", - "INH", - "Rifampicin)" - ], - "diseases": "['HIV Infection', 'Pulmonary TB']", - "diseases_list": [ - "HIV Infection", - "Pulmonary TB" - ], - "enrollment": "331.0", - "inclusion_criteria": "inclusion criteria: \n\n Age above 18 years. \n\n HIV-1/2 infected patients with Pulmonary TB. This includes sputum smear positive disease. \n\n Initially smear negative but Xpert-MTB positive or LPA positive taken as a surrogate marker for culture positivity (e.g. miliary TB, Mediastinal adenitis and Chest x-ray with persistent abnormality after antibiotics). as BACTEC (Becton-Dickinson) has been phased out ,Final inclusion will only be patients positive by LJ culture \n\n Persistent X-ray abnormality will be included for allocation. However final inclusion into both ITT and efficacy analysis will depend on positivity in LJ culture. \n\n Living within 40 km radius from the nearest sub centre of TRC and willing for attendance as prescribed. \n\n Likely to remain in the same area for at least one and half years after start of treatment. \n\n Willing for house visits and surprise checks. \n\n Willing to participate and give informed consent after going through the terms and conditions of the trial. \n\n ", - "exclusion_criteria": ": \n\n Patients with known hypersensitivity to rifampicin \n\n Pregnancy and lactation at initial presentation \n\n Major complications like HIV encephalopathy, renal dysfunction (serum creatinine > 1.5 mg% in the absence of dehydration) or jaundice (serum bilirubin > 2 mgs% along with SGOT /SGPT elevation > 2.5 times the upper limit of normal). \n\n Previous anti-tuberculosis treatment for more than 1 month. Prophylaxis (non-rifampicin containing regimen) will not be considered as prior antituberculosis treatment. \n\n Moribund, bedridden or unconscious patients. \n\n Co-morbid conditions like uncontrolled diabetes mellitus, cardiac failure, and malignancy at initial presentation. \n\n Major psychiatric illness. \n\n Patients on second line ART, mainly protease inhibitors, at initial presentation.", - "brief_summary": "Acquired Rifampicin Resistance has emerged as an important issue in the treatment of HIV-TB patients. It has not been a major problem in HIV-negative individuals treated for TB treated with standard intermittent regimens. The study would generate data on the efficacy of daily and thrice weekly regimen of ATT in pulmonary TB patients with HIV in the presence of highly active antiretroviral therapy (HAART). Not many trials have compared sputum conversion and adverse drug reaction between daily and intermittent regimens of ATT in HIV positive patients. This study provides a unique opportunity for comparison of daily and intermittent therapy for HIV patients with pulmonary TB looking into multiple dimensions of HIV-TB treatment namely efficacy, drug resistance, toxicity , drug interaction and immune reconstitution inflammatory syndrome. The primary outcome of the study is to compare the efficacy of three anti-TB regimens in a) reducing bacteriological failures and b) decreasing the emergence of Acquired Rifampicin Resistance (ARR). The secondary outcomes include unfavourable responses (clinical failures, deaths, relapses) as whole, treatment emergent adverse drug reactions, pharmacokinetic levels of ATT and incidence of immune reconstitution syndrome.", - "NCTID": "NCT00933790" - }, - { - "brief_title": "CF And Effects of Drugs Mixed Ex Vivo With Sputum for Mucolytic Treatment", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cystic Fibrosis']", - "diseases_list": [ - "Cystic Fibrosis" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy control subjects: \n\n Age 18-65 \n\n No history of lung disease \n\n Cystic fibrosis subjects: \n\n Age 18-65 \n\n No history of lung disease other than cystic fibrosis \n\n Diagnosis of CF if sweat chloride values > 60 mM on two separate pilocarpine iontophoresis sweat tests and/or two allelic CF-producing mutations in genetic analysis \n\n ", - "exclusion_criteria": ": \n\n Use of recreational drugs within 30 days prior to enrollment \n\n Use of tobacco within 30 days prior to enrollment, or > 10 pack-year tobacco history \n\n Pregnant or lactating females", - "brief_summary": "The investigators will collect samples of sputum from healthy volunteers and patients with cystic fibrosis for the purpose of: a) purifying airway mucins for plate-based binding studies and; b) assessment of the effects of carbohydrates on the rheologic properties of the sputum.~This study has two hypotheses:~Lectins from Pseudomonas aeruginosa and Aspergillus fumigatus bind to airway mucins in a fucose-dependent manner, and this binding can be inhibited by fucosyl glycomimetic compounds.~Fucosyl glycomimetics will compete with Pseudomonas aeruginosa lectin (PA-IIL) and Aspergillus fumigatus lectin (AFL) and disrupt lectin-driven mucin cross-linking in CF sputum.", - "NCTID": "NCT01533636" - }, - { - "brief_title": "Banlangen Granules Anti-seasonal Influenza Study", - "phase": "Phase 4", - "drugs": "['placebo of oseltamivir phosphate', 'oseltamivir phosphate', 'Banlangen (Radix Isatidis) granules', 'placebo of Banlangen(Radix Isatidis) granules']", - "drugs_list": [ - "placebo of oseltamivir phosphate", - "oseltamivir phosphate", - "Banlangen (Radix Isatidis) granules", - "placebo of Banlangen(Radix Isatidis) granules" - ], - "diseases": "['Influenza']", - "diseases_list": [ - "Influenza" - ], - "enrollment": "177.0", - "inclusion_criteria": "inclusion criteria: \n\n with confirmed influenza A(H1N1,H3N2) or influenza B virus infection by real time RT-PCR (rRT-PCR), age between 18-65 years old, axillary temperature \u226538\u00baC and with at least two constitutional symptoms (headache, chill, myalgia \uff0cor fatigue) and one respiratory symptom (cough \uff0csore throat,or coryza) . Illness onset had to be within 36 hours, and informed consent was obtained. \n\n ", - "exclusion_criteria": ": \n\n age younger than 18 or older than 65 years old. \n\n patients confirmed with bronchitis, pneumonia,pleural effusion and interstitial lung disease by Chest imaging (chest X-ray or CT) . \n\n Blood routine screening tests shows numeration of leukocyte 10.0\u00d7109/L or Neutrophil percentage \u226580%. \n\n Those have got suppurative tonsillitis or cough purulent sputum. \n\n Those with underling primary disorders, such as hematological disease, chronic obstructive pulmonary disease\uff08FEV1/FVC<70\uff05\uff0cFEV1/ predicated value<50\uff05\uff1b or respiratory failure or right heart failure\uff09\uff0c hepatic disease\uff08ALT or AST\u2265triple ULN\uff09, renal disease\uff08Serum Creatinine>2mg/dL\uff09,chronic congestive heart failure( NYHA \u2162-IV) \n\n 7. Patient is allergic to the study medication(s). 8. Women who are pregnant or may possibly become pregnant or are lactating with a positive urine pregnant test, obesity (abody mass index (BMI) of 25 kg/m2 or more). \n\n 9. Those with immunodeficiency ,such as malignant tumor ; Organs or bone marrow transplantation ; AIDS ;or taking immune inhibitors during the last 3 months. \n\n 10. Doubt or does alcohol/drug abuse of history. 11. Those have participated in other clinical trial within three month before study randomization. \n\n 12. Two weeks before the test , those with acute respiratory Infection\uff0cotitis,or nasosinusitis . \n\n 13. Those already vaccinated or who will receive influenza vaccine. 14.other reasons not suitable for enrollment based on the investigator's discretion.", - "brief_summary": "This study aimed to evaluate the efficacy and safety of the nature herbal medicine Banlangen granules in patients infected with seasonal influenza A (H1N1,H3N2) and influenza B virus.", - "NCTID": "NCT02232945" - }, - { - "brief_title": "Implantation of Markers for the Radiotherapy of Lung Cancer Patients", - "phase": "Phase 1", - "drugs": "['radiation therapy treatment planning/simulation', 'implanted fiducial-based imaging']", - "drugs_list": [ - "radiation therapy treatment planning/simulation", - "implanted fiducial-based imaging" - ], - "diseases": "['Lung Cancer']", - "diseases_list": [ - "Lung Cancer" - ], - "enrollment": "6.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Diagnosis of non-small cell lung cancer \n\n Stage I-IIIB disease \n\n No prior surgical tumor resection \n\n Respiration-induced tumor motion > 5 mm \n\n Recruited by attending physician or research nurse at the Medical College of Virginia Hospitals \n\n PATIENT CHARACTERISTICS: \n\n Not pregnant \n\n No insufficient lung function or other parameters prohibiting a bronchoscopy \n\n Not a prisoner or institutionalized \n\n PRIOR CONCURRENT THERAPY: \n\n See Disease Characteristics \n\n Concurrent chemotherapy allowed", - "exclusion_criteria": "", - "brief_summary": "This clinical trial studies imaging markers in planning radiation therapy in patients with lung cancer. Implanting markers in the tumor that can be seen using imaging procedures during radiation therapy may allow x-rays to be sent directly to the tumor and cause less damage to normal tissue.", - "NCTID": "NCT00856427" - }, - { - "brief_title": "Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab Therapy (Study P04644AM1) (TERMINATED)", - "phase": "Phase 3", - "drugs": "['infliximab', 'DMARDs (methotrexate; chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89.']", - "drugs_list": [ - "infliximab", - "DMARDs (methotrexate; chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89." - ], - "diseases": "['Rheumatoid Arthritis']", - "diseases_list": [ - "Rheumatoid Arthritis" - ], - "enrollment": "8.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients aged >35 and <=65 years with a diagnosis of rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) criteria for at least 1 year and no more than 10 years prior to start of therapy; have active disease (Disease Activity Score [DAS] 28 >2.8 and <3.5), with changes in the DAS 28 score <0.6 within the 6 weeks before inclusion; have stable RA basic therapy according to standard criteria for at least 3 months; have a chest X-ray within 1 month prior to first infusion with no evidence of malignancy, infections, or fibrosis; and have screening laboratory test results that meet prespecified criteria. Patient must have at least one swollen joint. Patient must have evidence of erosive disease by x-ray at baseline. \n\n ", - "exclusion_criteria": ": \n\n Patients were excluded if they met any of the following criteria: \n\n Women who are pregnant, nursing, or planning pregnancy within 15 months after screening (i.e., approximately 6 months following last infusion); \n\n Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer; \n\n History of any other therapeutic agent targeted at reducing tumor necrosis factor (TNF); \n\n History of previous administration of infliximab; \n\n History of receiving human/murine recombinant products or has a known allergy to murine products; \n\n Serious infection (such as hepatitis, pneumonia or pyelonephritis) in the previous 3 months. Less serious infections (such as acute upper respiratory tract infection [colds] or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator. \n\n Active tuberculosis (TB) or evidence of latent TB (positive purified protein derivative [PPD] skin test, a history of old or latent TB or chest X-ray without adequate therapy for TB initiated prior to first infusion of study drug), or evidence of an old or latent TB infection without documented adequate therapy. Patients with a current close contact with an individual with active TB and patients who have completed treatment for active TB within the previous 2 years are explicitly excluded from the trial. Patients with a household member who has a history of active pulmonary TB should have had a thorough evaluation for TB prior to study enrollment as recommended by a local infectious disease specialist or published local guidelines of TB control agencies. \n\n Hepatitis B surface antigen or Hepatitis C (HCV) antibody positive; documented Human Immunodeficiency Virus (HIV) infection; \n\n Have an opportunistic infection, including but not limited to evidence of active cytomegalovirus, active pneumocystis carinii, aspergillosis, or atypical mycobacterium infection, etc, within the previous 6 months; \n\n Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, psychiatric, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis); \n\n Concomitant congestive heart failure >= New York Heart Association (NYHA) II; \n\n Have a transplanted organ (with the exception of a corneal transplant >3 months prior to screening); \n\n Fibromyalgia; \n\n Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence); \n\n History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or peri-aortic areas), or splenomegaly; or \n\n Known recent substance abuse (drug or alcohol).", - "brief_summary": "This Phase 3, randomized, open-label, multicenter study in rheumatoid arthritis (RA) patients with low disease activity (Disease Activity Score 28 [DAS28] >2.8 and <3.5) is being conducted to evaluate induction of remission by adding infliximab to pre-existing treatment versus no additional treatment. All subjects eligible for this study, aged >35 to <=65 years, will have a diagnosis of RA according to American College of Rheumatology (ACR) criteria, and will be offered additional treatment with infliximab. Prior to the start of treatment, subjects must be on a stable regimen of disease modifying antirheumatic drugs (DMARDs) for at least 3 months. Subjects will be randomized (1:1) to basic therapy with or without infliximab for a total duration of 38 weeks followed by a follow-up period of up to 6 months. Subjects randomized to basic therapy + infliximab will receive infliximab 3 mg/kg at Weeks 0, 2, 6, 14, 22, 30, and 38. The primary objective of the study is to assess the rate of remission according to DAS 28 (<2.6) at the end of treatment (after 38 weeks). Safety assessments include the incidence of adverse events, serious adverse events, and clinically notable abnormal vital signs and laboratory values.", - "NCTID": "NCT00521924" - }, - { - "brief_title": "The Effects of Infliximab Versus Methotrexate in the Treatment of Moderate to Severe Psoriasis (Study P04271AM2)(COMPLETED)", - "phase": "Phase 3", - "drugs": "['infliximab', 'methotrexate']", - "drugs_list": [ - "infliximab", - "methotrexate" - ], - "diseases": "['Psoriasis']", - "diseases_list": [ - "Psoriasis" - ], - "enrollment": "868.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult male and female subjects (>= 18 to 75 years of age) with a diagnosis of moderate to severe plaque-type psoriasis for at least 6 months prior to study screening (subjects with concurrent psoriatic arthritis may also be enrolled). \n\n Subjects must be eligible for phototherapy or systemic therapy for their psoriasis and must have a Baseline Psoriasis Area and Severity Index (PASI) score of 12 or greater and have at least 10% of their total body surface area (BSA) involved at Baseline. \n\n Subjects must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study. \n\n Subjects must also meet the tuberculosis (TB) eligibility assessment and screening criteria as follows: Have no history of latent or active TB prior to screening; have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study medication; within 1 month prior to the first administration of study medication, either have negative diagnostic TB test results (defined as 2 negative tuberculin skin tests) OR have a newly identified positive diagnostic TB test result (defined as at least 1 positive tuberculin skin tests) during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study medication. \n\n Subjects must have had a chest x-ray (posterior-anterior and lateral) within 3 months prior to Screening with no evidence of malignancy, infection, fibrosis, or current or old active TB. \n\n Specific parameters must also be met with regard to screening laboratory test results and liver enzymes in order to be eligible to participate in the study. \n\n ", - "exclusion_criteria": ": \n\n Subjects who have non-plaque forms of psoriasis, current drug-induced psoriasis, are pregnant, nursing, or planning pregnancy; \n\n Subjects previously treated with MTX or infliximab; subjects who are taking specific drugs within the specified time frame prior to Baseline as follows: any therapeutic agent targeted at reducing tumor necrosis factor (TNF) or any biologic, live virus or bacterial vaccinations within 3 months; any systemic medications or treatments that could affect psoriasis or PASI evaluations, or any systemic immunosuppressants or lithium within 4 weeks; any topical medications or treatments that could affect psoriasis or PASI evaluations within 2 weeks. The only allowed topical treatments for psoriasis are shampoos (containing tar or salicylic acid only) and topical moisturizers. Subjects should not use these topical agents during the morning prior to a study visit. Non-medicated shampoos may be used on the morning of a visit. \n\n Subjects with poor health, including concomitant congestive heart failure (CHF); history of chronic or recurrent infectious disease, as specified; human immunodeficiency virus, hepatitis B, or hepatitis C; demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis; systemic lupus erythematosus; or who have had serious infections (eg, hepatitis, pneumonia, or pyelonephritis], or who have been hospitalized or received IV antibiotics, or who had an opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB), or a transplanted organ within specified time frames; or other conditions as specified in the protocol. \n\n Subjects who have used any investigational drugs within 4 weeks of Screening, who are participating in other clinical studies, staff or family members of study staff are excluded from participation in the study.", - "brief_summary": "This is a Phase 3b, randomized, parallel-group, multicenter, active-controlled, open-label study of the efficacy and safety of infliximab compared with methotrexate (MTX) in the treatment of moderate to severe psoriasis in adults who were diagnosed with moderate to severe plaque-type psoriasis for at least 6 months prior to screening (subjects with concurrent psoriatic arthritis may also be enrolled).", - "NCTID": "NCT00251641" - }, - { - "brief_title": "Detection of Genetic Markers of Lung Cancer", - "phase": "", - "drugs": "['Biopsy of the major carinal area', 'Biopsy of abnormal & suspicious areas of the bronchial tree', 'Evaluation of the tumor for DNA mutations', 'Bronchoalveolar Lavage (BAL) for cytokine analysis', 'Correlation of flow cytometric & RT PCR for TNM stage', 'Analysis of lymph nodes']", - "drugs_list": [ - "Biopsy of the major carinal area", - "Biopsy of abnormal & suspicious areas of the bronchial tree", - "Evaluation of the tumor for DNA mutations", - "Bronchoalveolar Lavage (BAL) for cytokine analysis", - "Correlation of flow cytometric & RT PCR for TNM stage", - "Analysis of lymph nodes" - ], - "diseases": "['Lung Cancer']", - "diseases_list": [ - "Lung Cancer" - ], - "enrollment": "6000.0", - "inclusion_criteria": "inclusion criteria: \n\n Histologic confirmation of lung cancer, lung metastases from a primary site other than lung, mesothelioma or a radiographic lesion highly suspicious for malignancy \n\n Written informed consent. \n\n Must be scheduled for a biopsy or surgical resection \n\n ", - "exclusion_criteria": ": \n\n None", - "brief_summary": "The purpose of this research study is to determine the genetic changes and immunologic changes that are involved in the development and progression of bronchogenic lung cancer.", - "NCTID": "NCT00280202" - }, - { - "brief_title": "The Quality of Life Study in Psoriasis Patients After Ustekinumab Treatment", - "phase": "Phase 4", - "drugs": "['Ustekinumab']", - "drugs_list": [ - "Ustekinumab" - ], - "diseases": "['Psoriasis']", - "diseases_list": [ - "Psoriasis" - ], - "enrollment": "36.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects are non-immunocompromised males or females 18 years of age or older \n\n Subjects have moderate-to-severe (\u226510% total body surface area) plaque psoriasis \n\n Subject diagnosed at least 6 months prior to entering the study \n\n Negative urine pregnancy test within 7 days before the first dose of ustekinumab in all women (except those surgically sterile or at least 5 years postmenopausal) \n\n Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study. \n\n Are considered eligible according to the following tuberculosis (TB) screening criteria: \n\n Have no history of latent or active TB prior to screening. An exception is made for subjects currently receiving treatment for latent TB with no evidence of active TB, or who have a history of latent TB and documentation of having completed appropriate treatment for latent TB within 3 years prior to the first administration of study agent. It is the responsibility of the investigator to verify the adequacy of previous antituberculous treatment and provide appropriate documentation. \n\n Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination. \n\n Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study agent. \n\n Within 1 month prior to the first administration of study agent, have a negative QuantiFERON-TB Gold test result, or have a newly identified positive QuantiFERON-TB Gold test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent. The QuantiFERON-TB Gold test are not required at screening for subjects with a history of latent TB and ongoing treatment for latent TB or documentation of having completed adequate treatment as described above; Subjects with documentation of having completed adequate treatment as described above are not required to initiate additional treatment for latent TB. \n\n Have a chest radiograph both posterior-anterior and lateral views, taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current, active TB or old, inactive TB. \n\n Subject meets concomitant medication requirements or agrees to complete a washout for restricted medications prior to starting the study. \n\n Washout Period : \n\n Must not have initiated or changed any other medications that could affect psoriasis (e.g. beta blockers, lithium salts, antimalarials) within the 4 week period prior to Week 0 or during the study \n\n Subjects must not have received immunosuppressive, chemotherapy and/or systemic therapy including oral calcineurin inhibitors (such as cyclosporine), retinoids (Vitamin A and analogues), Methotrexate, Azathioprine, 6-thioguanine, Mycophenolate mofetil (MMF), Hydroxyurea, or cytokines (such as interferon-gamma) within the 4 week period prior to Week 0 or during the study \n\n Subjects must not have received phototherapy (broadband or narrow-band UVB) within the 2 week period prior to Week 0 or during the study. \n\n Subjects must not have received photochemotherapy (PUVA) within the 4 week period prior to week 0 or during the study \n\n Subjects must not have received TNF-\u03b1 inhibitors (such as infliximab, etanercept, adalimumab) within the 12 week period prior to Week 0 or during the study \n\n Subjects must not have received alefacept within the 12 week period prior to Week 0 or during the study. \n\n Subjects must not have received ustekinumab within the 12 week period prior to Week 0 or during the study. \n\n Subjects must not have received treatment with an investigational drug within the previous 4 weeks or 5 half-lives prior to Week 0 (whichever is longer) or participation in another clinical trial within the 4 week period prior to Week 0 or during the study \n\n ", - "exclusion_criteria": ": \n\n Subject is younger than 18 years of age. \n\n Subject has less than 10% body surface involvement of his/her psoriasis. \n\n Subjects with erythrodermic, pustular, or guttate psoriasis \n\n History of known or suspected intolerance to any of the ingredients of the investigational study product. \n\n Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis. \n\n Evidence of active infections such as fevers, chills, sweats, or history of untreated Lyme disease and active severe infections within 4 weeks before screening visit, or between the screening and Week 0 visits \n\n Subject has a history of listeriosis, untreated TB, persistent or active infections requiring hospitalization or treatment with IV antibiotics, IV antiretrovirals, or IV antifungals within 30 days of baseline, or oral antibiotics, antivirals, or antifungals for purpose of treating infection, within 14 days of baseline. \n\n Have a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening. \n\n Refer to inclusion criteria for information regarding eligibility with a history of latent TB. \n\n Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening. \n\n Have a chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of malignancy or current active infection, including TB. \n\n Have had a nontuberculous mycobacterial infection or opportunistic infection (eg. Cytomegalovirus, pneumocystosis, aspergillosis) within 6 months prior to screening. \n\n History of immune compromised status [e.g. human immunodeficiency virus (HIV) positive status or other immune suppressing drug] or a congenital or acquired immunodeficiency or subject testing positive for HIV, Hepatitis B, and/or Hepatitis C during screening procedures. \n\n Subject has a poorly controlled medical condition including, but not limited to, unstable cardiovascular disease, poorly controlled diabetes, recent stroke, history of recurrent infections, or any other condition for which, in the opinion of the investigator, participation in the study would place the subject at risk \n\n Subject has a history of or ongoing drug or alcohol abuse \n\n Subject is not willing to comply with wash-out requirements (see above) \n\n Subject is known, or suspected of being unable to comply with the study protocol", - "brief_summary": "This study aims to see if patient quality of life can be approved after treatment with an injectable medication called ustekinumab for the treatment of generalized psoriasis. The investigators hypothesize that the investigators will see improvement in quality of life.", - "NCTID": "NCT01511315" - }, - { - "brief_title": "Treatment Of Knee Osteoarthritis With Intra-Articular Infliximab", - "phase": "Phase 4", - "drugs": "['Infliximab', 'Placebo', 'Standard of Care: Methylprednisolone acetate']", - "drugs_list": [ - "Infliximab", - "Placebo", - "Standard of Care: Methylprednisolone acetate" - ], - "diseases": "['Osteoarthritis of the Knee']", - "diseases_list": [ - "Osteoarthritis of the Knee" - ], - "enrollment": "16.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults \u2265 age 35 but \u2264 age 85. \n\n Painful knees for 3-60 months. \n\n VAS joint pain score greater than 30 mm (scale 0-100) \n\n Knee radiograph showing minimal to moderate change (early OA). \n\n No NSAID therapy for at least one week. \n\n Have the capacity to understand and sign an informed consent form. \n\n Gender: Male or female \n\n Women must be postmenopausal (no menstrual period for a minimum of 1 year) or surgically sterilized and have a negative serum pregnancy test on entry in the study. Men must agree to use adequate birth control during the study for 6 months after the infusion of study agent. \n\n Men and women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last infusion. \n\n The screening laboratory test results must meet the following criteria \n\n WBC (white blood cell count): >3.5/uL \n\n Hemoglobin: > 10 gm/dl \n\n Platelets: > 100,000/ul \n\n Serum Creatinine: < 1.8 \n\n SGPT (ALT - alanine aminotransferase) <3 times ULN \n\n UA (urinalysis) with microscopic exam: WNL \n\n Negative tests for HbsAg or hepatitis C Ab \n\n PT/PTT: WNL \n\n Are considered eligible according to the following TB screening criteria: \n\n Have no history of latent or active TB prior to screening. An exception is made for subjects who have a history of latent TB (defined for the purposes of this study as having had a positive result from either the tuberculin skin test or the QuantiFERON-TB Gold test prior to screening) and documentation of having completed an adequate treatment regimen for latent TB within 3 years prior to the first administration of study agent under this protocol. Adequate treatment for latent TB is defined according to local country guidelines for immunocompromised patients. If no local guidelines for immunocompromised patients exist, US guidelines must be followed. It is the responsibility of the investigator to verify the adequacy of previous anti-TB treatment and provide appropriate documentation. \n\n Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination. \n\n Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study agent. \n\n Within 1 month prior to the first administration of study agent, either have negative diagnostic TB test results (defined as both a negative tuberculin skin test and a negative QuantiFERON-TB Gold test, as outlined in Attachment 3 and Attachment 4, respectively), or have a newly identified positive diagnostic TB test result (defined as either a positive tuberculin skin test or a positive QuantiFERON-TB Gold test) during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent. The tuberculin skin test and QuantiFERON-TB Gold test are not required at screening for subjects with a history of latent TB and documentation of having completed adequate treatment as described in Inclusion Criterion 12a. Furthermore, these subjects are not required to initiate additional treatment for latent TB. \n\n Have a chest radiograph (both posterior-anterior and lateral views), taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current active TB or old inactive TB. \n\n ", - "exclusion_criteria": ": \n\n Moderate to Severe OA, as determined by severe joint space narrowing (Kellgren grade IV) (7) in medial and lateral compartments \n\n Insulin-dependent diabetes mellitus. \n\n Systemic inflammatory illness, e.g. rheumatoid arthritis. \n\n Intra-articular injections within 3 months. \n\n Prior treatment with infliximab or other anti-TNF drug. \n\n Acute injury to knees (< 2 weeks) \n\n Women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion (this includes father's who plan on fathering a child within 6 months after their last infusion). \n\n Have had any previous treatment with monoclonal antibodies or antibody fragments. \n\n History of receiving human/murine recombinant products or a known allergy to murine products. A known allergy to murine product is definitely an exclusion criterion \n\n Documentation of a positive test for hepatitis B surface antigen or hepatitis C. \n\n Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results. \n\n Have a known history of serious infections (e.g., hepatitis, pneumonia, or pyelonephritis) in the previous 3 months. \n\n Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening \n\n Currently receiving Coumadin, Ticlid, Plavix, or heparin/heparin analog within 7 days prior to synovial biopsy. \n\n Currently receiving aspirin within 7 days prior to synovial biopsy. \n\n Have a chest radiograph at screening that shows evidence of malignancy or infection. \n\n Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (e.g., nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly. \n\n Currently have any known malignancy or have a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence as well as carcinoma in situ of the cervix. \n\n Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease. \n\n Are unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access. \n\n Use of any investigational drug within 30 days prior to screening or within 5 half-lives of the investigational agent, whichever is longer. \n\n Presence of a transplanted solid organ (with the exception of a corneal transplant > 3 months prior to screening). \n\n Have a concomitant diagnosis or history of congestive heart failure Grade III-IV. \n\n Have had a nontuberculous mycobacterial infection or opportunistic infection (e.g., cytomegalovirus, Pneumocystis carinii, and aspergillosis) within 6 months prior to screening.", - "brief_summary": "The purpose of this study is to determine if an anti-inflammatory drug, called infliximab, will reduce inflammation in the synovial lining in patients with an early stage of osteoarthritis of the knee. It will also help determine if the study medication decreases the accumulation of synovial fluid and prevents cartilage breakdown.", - "NCTID": "NCT01144143" - }, - { - "brief_title": "Evaluation of Reactive Oxygen Metabolites in the Value of COPD", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['COPD(Chronic Obstructive Pulmonary Disease)']", - "diseases_list": [ - "COPD(Chronic Obstructive Pulmonary Disease)" - ], - "enrollment": "320.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of COPD according to GOLD 2013 \n\n ", - "exclusion_criteria": ": \n\n A history of asthma or other chronic lung diseases Take Antioxidant therapy There are new or recurrent symptomatic myocardial ischemia, severe arrhythmia, cardiac insufficiency cerebrovascular disease Senile dementia or cognitive impairment cancer Severe liver and kidney and other viscera function insufficiency Language communication barriers Limb activity disorder The last 3 months participated in sports training", - "brief_summary": "This study through the long-term observation followed up for 2 years to find the change of the COPD patients blood ROMs, systematically evaluate the relationship between ROMs and the severity of COPD. Evaluate the differences of prognosis between the different oxidative stress level (according to the level of ROMs are divided into higher and normal phenotype). Explore the new oxidative stress evaluation index ROMs application value in COPD.", - "NCTID": "NCT02297633" - } - ], - "1": [ - { - "brief_title": "Early Molecular Detection for the Improved Diagnosis of Invasive Pulmonary Aspergillosis and Invasive Pulmonary Zygomycosis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Immunocompromised Host', 'Invasive Pulmonary Fungal Infection', 'Invasive Pulmonary Aspergillosis', 'Invasive Pulmonary Zygomycosis']", - "diseases_list": [ - "Immunocompromised Host", - "Invasive Pulmonary Fungal Infection", - "Invasive Pulmonary Aspergillosis", - "Invasive Pulmonary Zygomycosis" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Patients currently enrolled in any NIH IRB approved Clinical Center protocol or under treatment at the CNMC who are undergoing bronchoscopy or lung biopsy for diagnosis of possible invasive pulmonary aspergillosis or invasive pulmonary zygomycosis. \n\n Informed consent of the patient or the patient's legally authorized representative. \n\n Fulfillment of one or more of the following EORTC/MSG host criteria: \n\n History of neutropenia (ANC < 500/mm(3)) within the past 3 months temporally related to the onset of radiographic changes \n\n Receipt of an allogeneic HSCT \n\n Receipt of solid organ transplantation \n\n Prolonged use of corticosteroids at an average minimum dose of 0.3 mg/kg/day prednisone equivalent for > 3 weeks \n\n Treatment with other recognized T-cell immune suppressants such as cyclosporine, TNF alpha blockers, specific monoclonal antibodies such as alemtuzumab, nucleoside analogues during the past 90 days \n\n Myelodysplastic syndrome \n\n Severe aplastic anemia \n\n Cushing's disease \n\n HIV/AIDS \n\n Primary immunodeficiencies (such as chronic granulomatous disease, severe combined immunodeficiency) \n\n The presence of one or more of the following signs on chest CT or radiograph: \n\n Dense well circumscribed lesions with or without a halo sign \n\n Air crescent sign \n\n Cavity \n\n Focal, segmental or lobar infiltrates \n\n ", - "exclusion_criteria": ": \n\n Interstitial or diffuse infiltrates on chest CT or radiograph \n\n Inability to provide informed consent \n\n Children weighing less than 10 kg \n\n Any other concomitant condition, which in the opinion of the investigator would place the patient at risk by participating in the study", - "brief_summary": "Background:~Fungal infections of the lung (pneumonia) can be caused by molds, such as Aspergillus and Zygomycetes, but these causes are often difficult for a doctor to diagnose. Early and accurate diagnosis of these infections can help doctors to select the correct medicines for proper treatment.~A number of methods are used to diagnose fungal pneumonia. Ones that are commonly used in clinical practice include radiographic imaging (chest X-rays and computed tomography (CT) scans), blood tests, and cultures taken from fluid from the lungs (broncho-alveolar lavage (BAL) fluid). Other new methods may improve the diagnosis of fungal pneumonias. These methods include tests that can detect DNA from the fungal germ in blood and BAL fluid of some patients with these infections.~Objectives:~To help develop better and more accurate methods of diagnosing fungal lung infections.~To detect fungal DNA and chemicals in the bloodstream and BAL fluid of immunocompromised patients with pneumonia.~Eligibility:~- Immunocompromised patients who are currently enrolled in another NIH protocol and who have a CT scan that shows a possible fungal infection of the lung.~Design:~Researchers will review patients' existing medical records and CT scans, and current pneumonia treatment plans.~Patients will provide blood and BAL samples for the duration of their treatment for pneumonia, as required by researchers. Additional CT scans will not be performed, except as part of existing treatment plans.", - "NCTID": "NCT00923832" - }, - { - "brief_title": "Diagnosing Pulmonary Aspergillosis in Patients With Hematological Malignancies: A Multicentre Prospective Evaluation of an Aspergillus PCR Assay and a Galactomannan ELISA in Bronchoalveolar Lavage Samples", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Invasive Aspergillosis']", - "diseases_list": [ - "Invasive Aspergillosis" - ], - "enrollment": "87.0", - "inclusion_criteria": "inclusion criteria: \n\n - hematological patients with lung infiltrates at high risk for invasive aspergillosis \n\n ", - "exclusion_criteria": ": \n\n - patients without informed consent", - "brief_summary": "Diagnosing invasive pulmonary aspergillosis (IPA) remains a challenge in patients (pts) with hematological malignancies. The clinical significance of testing bronchoalveolar lavage (BAL) samples both with polymerase chain reaction (PCR) and Aspergillus galactomannan (GM) ELISA is unclear, and the BAL cutoff for GM has not been clearly defined yet. Using a validated nested PCR assay and a GM ELISA, we prospectively examine BAL samples from hematological patients at high risk of PA.", - "NCTID": "NCT01430663" - }, - { - "brief_title": "Evaluation of Exhaled Breath Condensate in the Diagnosis of Invasive Pulmonary Aspergillosis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Invasive Pulmonary Aspergillosis']", - "diseases_list": [ - "Invasive Pulmonary Aspergillosis" - ], - "enrollment": "24.0", - "inclusion_criteria": "inclusion criteria: \n\n hospitalisation in the hematology or intensive care department \n\n age > 16 years \n\n informed consent \n\n proven or probable IPA (EORTC/ MSG criteria) \n\n galactomannan positivity in BAL or serum \n\n ", - "exclusion_criteria": ": \n\n age < 16 years", - "brief_summary": "The purpose of this study is to evaluate the diagnostic potential of biomarkers for invasive pulmonary aspergillosis in exhaled breath condensate.", - "NCTID": "NCT01247142" - }, - { - "brief_title": "Trial on the Efficacy and Safety of Two Different Glucocorticoid Dose Regimens in Allergic Bronchopulmonary Aspergillosis", - "phase": "Phase 2; Phase 3", - "drugs": "['Glucocorticoids', 'Glucocorticoids']", - "drugs_list": [ - "Glucocorticoids", - "Glucocorticoids" - ], - "diseases": "['Allergic Bronchopulmonary Aspergillosis']", - "diseases_list": [ - "Allergic Bronchopulmonary Aspergillosis" - ], - "enrollment": "92.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of ABPA \n\n Presence of all the following three criteria: \n\n immediate cutaneous hyperreactivity on aspergillus skin test \n\n elevated total IgE levels > 1000 IU/mL \n\n A fumigatus specific IgE levels > 0.35 kU/L, AND, \n\n Presence of two of the following criteria: \n\n presence of serum precipitating antibodies against A fumigatus \n\n fixed or transient radiographic pulmonary opacities \n\n absolute eosinophil count > 1000/\u00b5L \n\n central bronchiectasis on HRCT \n\n ", - "exclusion_criteria": ": \n\n If they have taken glucocorticoids for more than three weeks in the preceding six months \n\n Failure to give informed consent \n\n Enrollment in another trial of ABPA", - "brief_summary": "Allergic bronchopulmonary aspergillosis (ABPA) is a pulmonary disorder caused by a complex hypersensitivity response to antigens released by the fungus Aspergillus fumigatus. Oral corticosteroids are currently the treatment of choice for ABPA associated with bronchial asthma. They not only suppress the immune hyperfunction but are also anti-inflammatory. However, there is no data to guide the dose and duration of glucocorticoids and different regimens of glucocorticoids have been used in literature. The disorder is highly prevalent in India. The investigators have previously reported their experience with screening stable outpatients with bronchial asthma and acute severe asthma for ABPA. The investigators have also recently reported the prognostic factors associated with clinical outcomes in patients with ABPA.~The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and safety of two different glucocorticoid dose protocols in patients with ABPA.", - "NCTID": "NCT00974766" - }, - { - "brief_title": "Voriconazole With or Without Interferon Gamma in Treating Patients With Aspergillosis or Other Fungal Infections", - "phase": "Phase 2", - "drugs": "['recombinant interferon gamma', 'voriconazole']", - "drugs_list": [ - "recombinant interferon gamma", - "voriconazole" - ], - "diseases": "['Infection', 'Unspecified Adult Solid Tumor, Protocol Specific']", - "diseases_list": [ - "Infection", - "Unspecified Adult Solid Tumor", - "Protocol Specific" - ], - "enrollment": "", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Proven or probable invasive aspergillosis or other filamentous fungal infection by cytology, histopathology, or culture within the past 7 days \n\n Presenting with 1 of the following: \n\n Cancer \n\n Aplastic anemia \n\n Inherited immunodeficiencies \n\n Autoimmune deficiency disorders \n\n Acquired immunodeficiencies \n\n Recipient of autologous peripheral blood stem cell or bone marrow transplantation \n\n CNS aspergillosis or other filamentous fungal infection allowed \n\n No invasive zygomycosis infection \n\n PATIENT CHARACTERISTICS: \n\n Age \n\n 2 and over \n\n Performance status \n\n Not specified \n\n Life expectancy \n\n At least 7 days \n\n Hematopoietic \n\n Not specified \n\n Hepatic \n\n ALT no greater than 5 times upper limit of normal \n\n Renal \n\n Creatinine clearance at least 30 mL/min \n\n Other \n\n Not pregnant or nursing \n\n Negative pregnancy test \n\n Fertile patients must use effective barrier contraception \n\n No prior significant CNS disorder (e.g., multiple sclerosis or uncontrolled seizures) \n\n No prior grade 3 or 4 toxicity or severe allergic reaction to interferon gamma \n\n No prior intolerance or hypersensitivity to voriconazole or other azoles \n\n No acute or chronic graft-versus-host disease \n\n No conditions that would preclude study compliance \n\n PRIOR CONCURRENT THERAPY: \n\n Biologic therapy \n\n See Disease Characteristics \n\n No prior allogeneic peripheral blood or bone marrow transplantation \n\n No concurrent interferon alfa \n\n Chemotherapy \n\n Not specified \n\n Endocrine therapy \n\n Not specified \n\n Radiotherapy \n\n Not specified \n\n Surgery \n\n No prior solid organ transplantation \n\n Other \n\n Prior voriconazole allowed \n\n At least 24 hours since prior administration of any of the following: \n\n Astemizole \n\n Cisapride \n\n Pimozide \n\n Quinidine \n\n Sirolimus \n\n Terfenadine \n\n Rifabutin \n\n Ergot alkaloids \n\n Sildenafil citrate \n\n Amiodarone \n\n Flecainide \n\n Systemic lidocaine \n\n More than 14 days since prior long-acting barbiturates, carbamazepine, or rifampin \n\n No other concurrent systemic antifungal drugs \n\n No other concurrent investigational agents", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Antifungals such as voriconazole may be effective in controlling fungal infections. Combining voriconazole with interferon gamma may be more effective than voriconazole alone in treating fungal infections.~PURPOSE: Randomized phase II trial to compare the effectiveness of voriconazole with or without interferon gamma in treating patients who have aspergillosis or other fungal infections.", - "NCTID": "NCT00059878" - }, - { - "brief_title": "Individualisation of Voriconazole Antifungal Therapy Antifungal Therapy", - "phase": "Phase 2", - "drugs": "['VFEND']", - "drugs_list": [ - "VFEND" - ], - "diseases": "['Immunocompromised Patient', 'Aspergillosis', 'Fusarium']", - "diseases_list": [ - "Immunocompromised Patient", - "Aspergillosis", - "Fusarium" - ], - "enrollment": "33.0", - "inclusion_criteria": "inclusion criteria: \n\n Any adult \u226518 years old \n\n Patients where a new course of voriconazole is indicated for suspected or confirmed invasive aspergillosis or other serious fungal infections that is deemed by the treating physician to be susceptible to voriconazole \n\n Patients must have venous access to permit the administration of voriconazole and enable the procurement of multiple plasma samples to measure voriconazole concentrations. \n\n Estimated creatinine clearance \u2265 50 mL/min \n\n Able to give written informed consent \n\n Considered fit to receive the trial treatment \n\n Able to remain in the hospital for at least 5 days or until they complete their trial treatment \n\n Female patients must satisfy the investigator that they are not pregnant, or are not of childbearing potential, or are using adequate contraception \n\n Men must also use adequate contraception \n\n ", - "exclusion_criteria": ": \n\n Patients with an estimated creatinine clearance < 50 mL/minute (this precludes the use of intravenous voriconazole) \n\n Patients receiving any form of renal replacement therapy i.e. haemodialysis or haemofiltration \n\n Patients with hepatic insufficiency \n\n Female patients that are pregnant, breast feeding or planning pregnancy during the study \n\n Past history of intolerance to voriconazole \n\n Age <18 \n\n Evidence of a clinically relevant fungal isolate that is resistant to voriconazole \n\n QT prolongation on ECG \n\n Use of other medications that contraindicate the use of voriconazole \n\n Patients receiving any other medications that are contraindicated with the use of voriconazole i.e. terfenadine, long acting barbiturates, ergot alkaloids, etc. (Refer to SMPC). Only patients on rifampicin, rifabutin, phenytoin, and carbamazepine would have voriconazole precluded. Voriconazole influences with the pharmacokinetics of many additional agents- (see SMPC)- most importantly anti-rejection compounds- cyclosporine, tacrolimus] \n\n Uncontrolled cardiac, respiratory or other disease or any serious medical or psychiatric disorder that would preclude trial therapy or informed consent. \n\n Hypersensitivity to Voriconazole, its excipients or other triazoles", - "brief_summary": "This is a trial to determine whether giving a patient a tailored dose of voriconazole is safe and effective.", - "NCTID": "NCT01887457" - }, - { - "brief_title": "Sputum Pharmacokinetics of TB Drugs and Bacterial Drug Resistance", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Tuberculosis', 'Non-Tuberculosis Mycobacteria']", - "diseases_list": [ - "Tuberculosis", - "Non-Tuberculosis Mycobacteria" - ], - "enrollment": "215.0", - "inclusion_criteria": "inclusion criteria: \n\n At least 18 years of age \n\n Diagnosis of TB (and/or NTM for NIH clinical center subjects) \n\n Ongoing signs and/or symptoms of pulmonary TB (and/or NTM at the NIH CC) \n\n Suspected drug resistance (drug susceptible allowed at the NIH CC) \n\n Available to provide at least 3 sputa over 2 or more days \n\n Taking anti-tuberculosis medicines (or NTM meds at NIH CC) during the time sputa are provided \n\n Thought likely to be Mycobacterium culture positive (including NTM infected for the NIH CC) by enrolling physician \n\n GeneXpert MTB/RIF sputum TBpositive (China subjects only) \n\n Likely able to produce sputum samples while on study \n\n Willing to provide blood samples \n\n Willing to have samples stored \n\n ", - "exclusion_criteria": ": \n\n Acute liver or kidney disease \n\n Conditions which compromise the subject s ability to take or absorb oral drugs", - "brief_summary": "Background:~Many people around the world get tuberculosis (TB) and non-tuberculous mycobacteria (NTM) infections. Sometimes medicine that treats these infections does not get to where the bacteria are in the lungs. Researchers want to find a way to tell if enough medicine is getting to where it is needed in the lungs. They will look at how much medicine is in your sputum (what you cough up) compared to how much is in your blood. They will also investigate a new test to quickly figure out what medicines are likely to treat TB effectively.~Objective:~To determine the relationship between the concentration of TB drugs in plasma and sputum over time.~Eligibility:~People ages 18 and older who have TB or NTM infection that is suspected to be drug resistant. They must be taking TB or NTM medicines.~Design:~Participants will be screened with medical history.~Participants will be in the study for 2 8 days.~Participants will give 3 or more sputum samples over at least 2 different days. They will cough sputum into a cup.~Participants will have blood drawn 4 times a day on 2 different days.", - "NCTID": "NCT02534727" - } - ], - "2": [ - { - "brief_title": "Diagnosis of Invasive Pulmonary Aspergillosis (IPA) in Critically Ill Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Survival After IPA', 'Risk Factors for IPA']", - "diseases_list": [ - "Survival After IPA", - "Risk Factors for IPA" - ], - "enrollment": "85.0", - "inclusion_criteria": "inclusion criteria: \n\n > 18 years \n\n positive aspergillus culture in respiratory tract sample OR \n\n positive aspergillus galactomannan in respiratory tract sample \n\n ", - "exclusion_criteria": ": \n\n no inform consent \n\n age < 18 years", - "brief_summary": "Invasive pulmonary aspergillosis (IPA) is difficult to diagnose and remains a cause of high morbidity and mortality in critically ill patients in the ICU. Accepted diagnostic protocols for haemato-oncological patients are not applicable for critically ill patients in ICUs. Definitive discrimination between aspergillic colonisation and IPA often depends on the clinical experience of the treating physician, evaluating clinical signs, co-morbidities, and course of the disease. Life saving treatment with the first line antimycotic Voriconazol (Vfend\u00ae) can only be initiated after diagnosis of IPA.~In this prospective clinical trial the investigators aim to structure, optimize and fast track the diagnostic pathway of IPA in critically ill patients treated in our ICU-department.", - "NCTID": "NCT01866020" - }, - { - "brief_title": "Voriconazole vs. Amphotericin B in the Treatment of Invasive Aspergillosis", - "phase": "Phase 3", - "drugs": "['Voriconazole', 'Amphotericin B']", - "drugs_list": [ - "Voriconazole", - "Amphotericin B" - ], - "diseases": "['Acquired Immunodeficiency Syndrome', 'Aspergillosis', 'HIV Infections', 'Immunologic Deficiency Syndromes', 'Neutropenia']", - "diseases_list": [ - "Acquired Immunodeficiency Syndrome", - "Aspergillosis", - "HIV Infections", - "Immunologic Deficiency Syndromes", - "Neutropenia" - ], - "enrollment": "10.0", - "inclusion_criteria": "Males and females of greater than 12 years of age with any of the following conditions: \n\n Allogeneic or autologous bone marrow/ peripheral stem cell transplant. \n\n Hematological malignancy (including lymphoma). \n\n Aplastic anemia and myelodysplastic syndromes (currently on immunosuppressive treatment). \n\n Solid organ transplantation. \n\n Solid organ malignancy (after cytotoxic chemotherapy). \n\n HIV infection/AIDS. \n\n High dose prolonged corticosteroid therapy (greater than or equal to 20 mg daily of prednisone or equivalent for greater than 3 weeks) or prolonged therapy with other immunosuppressive agents (e.g., azathioprine, methotrexate). \n\n WITH a diagnosis of definite or probable acute invasive aspergillosis. \n\n The fungal infection at baseline should represent a new episode of acute invasive aspergillosis. Any course of systemic treatment with amphotericin B (conventional or lipid formulation) or itraconazole should have been completed at least 8 weeks prior to study entry. \n\n Signed informed consent must be obtained prior to study participation (patient, relative or legal representative). For patients aged 12-17 years, the written informed consent of the parents or legal guardian must also be obtained. \n\n Women of child bearing potential must have a negative pregnancy test at entry and must agree to use barrier methods of contraception throughout the study. \n\n No patients with sarcoidosis, aspergilloma or allergic bronchopulmonary aspergillosis. \n\n No patients with chronic invasive aspergillosis with a duration of symptoms or radiological findings for more than 4 weeks prior to study entry. \n\n No patients that have received systemic antifungal therapy at doses greater than 0.5 mg/kg/day for conventional or lipid formulations of amphotericin B or greater than 200 mg/day of itraconazole, for more than 96 hours during the two week period prior to study entry. \n\n No patients with a diagnosis of CMV pneumonia. \n\n No pregnant or lactating females. \n\n No patients with a history of hypersensitivity or intolerance to azole antifungal agents including miconazole, ketoconazole, fluconazole, or itraconazole. \n\n No patients with a history of hypersensitivity or severe intolerance (despite supportive therapy) to conventional or a lipid formulation of amphotericin B. \n\n No subjects who are receiving and cannot discontinue the following drugs at least 24 hours prior to randomization: Terfenadine, cisapride and astemizole (due to the possibility of QTc prolongation); Sulphonylureas (as these compounds have a narrow therapeutic window and an increase in plasma levels may lead to hypoglycemia). \n\n No subjects who have received the following drugs within 14 days prior to randomization: Rifampin, carbamazepine and barbiturates as these are potent inducers of hepatic enzymes and will result in undetectable levels of voriconazole. \n\n No patients who are receiving or are likely to received any investigational drug (any unlicensed new chemical entity), except one of the following classes of medications: cancer chemotherapeutic agents, antiretrovirals, therapies for HIV/AIDS-related opportunistic infections. \n\n No patients who are receiving the following medications or treatments during the study period: G-CSF or GM-CSF (for other than of granulocytopenia) any systemic antifungal medication active against Aspergillus white blood cell transfusions. \n\n No patients with the following abnormalities of liver function tests: AST, ALT greater than 5x ULN (upper limit normal); alkaline phosphatase, total bilirubin greater than 5x ULN. \n\n No patients with renal insufficiency that would contraindicate treatment with initial randomized therapy (serum creatinine greater than 2.5 mg/dl). \n\n No patients with a life expectancy of less than 72 hours. \n\n No patients on artificial ventilation, unlikely to be extubated within 24 hours of study entry. \n\n No patients for whom written informed consent cannot be obtained. \n\n No patients that have already participated in this trial. \n\n No patients with any condition which, in the opinion of the investigator, could affect patient safety, preclude evaluation of response, or render it unlikely that the contemplated course of therapy can be completed.", - "exclusion_criteria": "", - "brief_summary": "Invasive aspergillosis is a fungal disease which is increasing in incidence with the increase in immunocompromised persons in our population. Persons with prolonged neutropenia secondary to cytotoxic chemotherapies are at the highest risk for acute aspergillosis. Patients undergoing bone marrow transplantation, receiving prolonged corticosteroid or other immunosuppressive therapies, and persons with HIV infection and AIDS are also at risk. Even with antifungal therapy, aspergillosis in its acute invasive forms has a high mortality. In bone marrow transplantation patients and in those whose infection involves the brain, this mortality is greater than 90%. Amphotericin B in its conventional form, is the current standard treatment for this disease. Response to therapy with amphotericin B usually ranges between 20-60% in most studies. The higher response rates are usually seen in those patients who can tolerate this agent for at least 14 days. Because of its nephrotoxicity and other adverse effects, alternatives to conventional amphotericin B have been sought. These currently include liposomal forms of amphotericin B and itraconazole. Although these forms show a decrease in adverse effects, the efficacy of these drugs has not been shown to be equivalent to conventional amphotericin B.~Voriconazole is an investigational antifungal drug currently being brought to phase III trials in the US. This azole has been shown active against Aspergillus spp. in vitro, and in animal models and early human trials to be effective against aspergillosis. It has been shown to be well-tolerated and is available in an intravenous and oral formulation.~This study will evaluate the efficacy, safety, and toleration of voriconazole compared to conventional therapy with amphotericin B as primary treatment of acute invasive aspergillosis in immunocompromised patients. Patients will be randomized to open-labelled therapy with voriconazole or amphotericin B in a one-to-one ratio.", - "NCTID": "NCT00001646" - }, - { - "brief_title": "Diagnosing Invasive Aspergillosis by Polymerase Chain Reaction (PCR) Based Investigation of Bronchoalveolar Lavage Samples During Antifungal Therapy", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Invasive Aspergillosis']", - "diseases_list": [ - "Invasive Aspergillosis" - ], - "enrollment": "221.0", - "inclusion_criteria": "inclusion criteria: \n\n immunocomprimised patients with high risk of invasive aspergillosis and lung infiltrates \n\n informed consent \n\n ", - "exclusion_criteria": ": \n\n Children under the age of 5 years \n\n Informed consent not available", - "brief_summary": "Invasive pulmonary aspergillosis (IPA) remains a major cause for morbidity and mortality in patients (pts) with hematologic malignancies. As culture-based methods only yield results in a minority of patients, using non-culture-based methods for detection of aspergillosis in clinical specimens becomes increasingly important. Analyzing bronchoalveolar lavage (BAL) samples with polymerase chain reaction (PCR) is promising, however, the influence of current antifungal drugs on the performance of this diagnostic tool remains controversial.~The aim of the trial is to elucidate on the performance of BAL PCR under antifungal treatment.", - "NCTID": "NCT01448226" - }, - { - "brief_title": "COMBISTRAT: AmBisome\u00ae in Combination With Caspofungin for the Treatment of Invasive Aspergillosis", - "phase": "Phase 4", - "drugs": "['Ambisome', 'caspofungin']", - "drugs_list": [ - "Ambisome", - "caspofungin" - ], - "diseases": "['Invasive Aspergillosis']", - "diseases_list": [ - "Invasive Aspergillosis" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults and children > 10 years old. \n\n The patient is able to understand and has signed a written informed consent OR the parent or legal guardian is able to understand and has signed a written informed consent, which must be obtain prior to the initiation of any study procedures. \n\n Immunocompromised due to hematologic malignancies, chemotherapy-induced neutropenia, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy (\u2265 20 mg Prednisone or equivalent for \u2265 3 weeks) or treatment with other immunosuppressant medications. \n\n Evidence of Proven or Probable Invasive Aspergillosis, by modified EORTC criteria (Appendix 2), as modified below: \u2022 Proven Invasive Aspergillosis \u2022 Histopathologic or cytopathologic examination showing hyphae consistent with the presence of aspergillus from needle aspiration or biopsy specimen with evidence of associated tissue damage (either microscopically or unequivocally by imaging); or \u2022 Positive culture result for aspergillosis from a sample obtained by sterile procedure from normally sterile and clinically or radiologically abnormal site consistent with infection, excluding urine and mucous membranes \u2022 Probable Invasive Aspergillosis \u2022 At least 1 host factor criterion; and \u2022 1 microbiological criterion; and \n\n 1 major (or 2 minor) clinical criteria from abnormal site consistent with infection; and \u2022 No other pathogens detected to account for the clinical or radiographic signs of infection \n\n Or (Modification of EORTC Criteria): \u2022 Patients with recent Neutropenia (absolute neutrophil count < 500 cells/mm3 within 14 days of study enrollment); and \u2022 Chest CT scan positive for Halo or Air Crescent Sign (see Section 4.2.1, Diagnostic Considerations, below) and \u2022 No other pathogens detected to account for the clinical or radiographic signs of infection \n\n Females of childbearing potential must be surgically incapable of pregnancy, or practicing an acceptable method of birth control with a negative pregnancy test (blood or urine) at baseline. \n\n ", - "exclusion_criteria": ": \n\n Life expectancy < 30 days \n\n Allogenic stem cell transplant in the 6 previous months \n\n Chronic invasive fungal infection, defined as signs/symptoms of invasive fungal infection present for > 4 weeks preceding entry into study \n\n Prior anti-fungal systemic therapy of \u2265 96 hours for the current, documented IA. (On the other hand, is permissible prior systemic anti-fungal therapy for prophylaxis or as empiric therapy for febrile neutropenia). \n\n Use of another investigational, unlicensed drug within 30 days of screening or concurrent participation in another clinical trial using an investigational, unlicensed drug \u2022 Serum creatinine > 2x upper limit of normal (ULN) \n\n Serum ALT or AST > 5 x ULN \n\n Pregnant or lactating women \n\n History of allergy or serious adverse reaction to any polyene anti-fungal agent or echinochandin derivatives", - "brief_summary": "Combination therapy of caspofungin and amphotericin B could be a useful treatment option in invasive fungal disease, but before it can be routinely recommended; carefully controlled and well-designed randomized clinical trials are needed.", - "NCTID": "NCT00334412" - }, - { - "brief_title": "Trial of Combination Antifungal Therapy (Vori+Mica vs. Vori+Placebo) in Invasive Aspergillosis", - "phase": "Phase 2", - "drugs": "['Voriconazole, micafungin']", - "drugs_list": [ - "Voriconazole", - "micafungin" - ], - "diseases": "['Aspergillosis']", - "diseases_list": [ - "Aspergillosis" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n The patient or legally authorized representative has signed an informed consent/assent. \n\n Assent will be obtained as required by the UAMS IRB. \n\n The patient has a diagnosis of proven or probable invasive aspergillosis and with positive Aspergillus GM index (\u22650.5 ng/ml) provide the patient is not receiving antibiotics, such as piperacillin-tazobactam, that are known to cause false positive GMI \n\n The patient is 18 years of age or older. \n\n ", - "exclusion_criteria": ": \n\n The patient is being treated with an unlicensed investigational drug for aspergillosis. \n\n The patient has been administered an antifungal agent (voriconazole, itraconazole, posaconazole, caspofungin, micafungin, anidulafungin, amphotericin B, or lipid formulation of amphotericin B) for > 7 days immediately prior to randomization for treatment of the Probable, or Proven invasive aspergillosis for which the patient is being enrolled. \n\n Patient has invasive aspergillosis but with negative Aspergillus GM index. \n\n The patient is pregnant or lactating. If the patient is female and of childbearing potential, the patient must have a negative pregnancy test and avoid becoming pregnant while receiving study drug. A pregnancy test should be performed within 14 days prior to the first dose of study drug. \n\n The patient has alkaline phosphatase, ALT, AST or total bilirubin greater than five times the upper limit of normal. \n\n The patient has hepatic cirrhosis. \n\n Patients with creatinine > 3 will be enrolled only if able to receive oral voriconazole (specify oral loading dose is 6 mg/kg PO Q 12 hours for 24 hours) then oral maintenance 200 mg PO q 12 hours). \n\n The patient is on artificial ventilation, and unlikely to be extubated within 24 hours of study entry. \n\n The patient has a history of allergy, hypersensitivity, or any serious reaction to the azole or echinocandin class of antifungal agents. \n\n The patient has previously enrolled into this study. \n\n The patient has a concomitant medical condition, which in the opinion of the Investigator may create an unacceptable additional risk. \n\n The patient has an active microbiologically-documented deep infection due to a non-Aspergillus mold. \n\n The patient has a life expectancy of less than seven days.", - "brief_summary": "The purpose of this study is to evaluate the therapeutic effectiveness of combination antifungal therapy (CAT) of voriconazole plus micafungin versus voriconazole plus placebo equivalent as primary therapy for invasive aspergillosis (IA) in patients with hematological cancer.", - "NCTID": "NCT01207128" - }, - { - "brief_title": "Galactomannan Antigen in Bronchoalveolar Lavage in the Diagnosis of Invasive Aspergillosis in Neutropenic Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Invasive Aspergillosis']", - "diseases_list": [ - "Invasive Aspergillosis" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n 100 BAL in hematological neutropenic patients at high risk of IA, admitted to our hospital, in which we usually perform a BAL for microbiological study when they present persistent fever and an opportunist infection suspicion. \n\n 100 BAL in patients without hematological illness and without IA suspicion, in which we perform an BAL because of another reason. \n\n ", - "exclusion_criteria": ": \n\n Patients without fulfilling inclusion criteria. \n\n Patients with some contraindication to perform a bronchoscopy.", - "brief_summary": "Invasive Aspergillosis (IA) is a very serious fungal infection. Hematological patients are the most affected group. IA has a very high morbimortality due to its rapid progression and because it is very difficult to be early diagnosed. Diagnosis is used to be done too late or even post-mortem. They are two new methods (techniques) trying to make the diagnosis on an early stage: detection of Galactomannan antigen of Aspergillus species and real - time polymerase chain reaction (PCR) of its DNA in blood. IA in immunocompromised patients is mainly located in lungs, so our hypothesis is that in patients where the investigators suspect IA the investigators should find earlier Galactomannan antigen or real -time PCR of Aspergillus in respiratory samples such as bronchoalveolar lavage (BAL), and its detection could be useful for diagnosis.~Objectives: To detect Galactomannan Antigen and Real Time - PCR for Aspergillus DNA in bronchoalveolar lavage. To validate the routine utility of these tests in BAL as a diagnostic method of IA and investigate if Galactomannan Antigen and Real Time - PCR for Aspergillus DNA in bronchoalveolar lavage can optimize blood test sensibility.~Methods: Prospective study. The investigators will include 200 patients. 100 of them will be hematological patients, neutropenic and at high risk to develop an IA. The other 100 will be patients without risk or no suspicion at all of IA. The investigators will perform a BAL in all patients. And blood detection of Galactomannan Antigen in hematological patients. The investigators will perform a standard microbiological culture of BAL and Galactomannan Antigen in both samples (bronchoalveolar lavage and blood). The investigators also will carry out Real Time - PCR for Aspergillus DNA detection in bronchoalveolar lavage.~Expected results: To detect Galactomannan Antigen and Real Time - PCR for Aspergillus DNA in BAL with more specificity and making earlier diagnosis than in blood. The investigators also expect to implant these techniques in BAL in the routine for IA diagnosis in neutropenic patients.", - "NCTID": "NCT01128907" - }, - { - "brief_title": "Correlation Between Circulating Galactomannan and Beta-D-glucan and Clinical Outcome of Invasive Aspergillosis", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Invasive Aspergillosis']", - "diseases_list": [ - "Invasive Aspergillosis" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n proven or probable invasive aspergillosis with positive GM antigen test \n\n ", - "exclusion_criteria": ": \n\n Seronegative aspergillosis", - "brief_summary": "The investigators hypothesize that early galactomannan and beta-D-glucan features, namely the height of the initial value at the time of diagnosis and the subsequent rate of marker decay within the first week(s) following therapy (day 7, day 14) are important factors in predicting clinical outcome.", - "NCTID": "NCT01176071" - } - ] - }, - { - "patient_id": "sigir-201523", - "patient": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", - "0": [ - { - "brief_title": "Ability of Bedside Ultrasound to Predict Progression of Severity of Disease in Dengue Fever", - "phase": "", - "drugs": "['diagnostic bedside ultrasound']", - "drugs_list": [ - "diagnostic bedside ultrasound" - ], - "diseases": "['Dengue', 'Disease Progression']", - "diseases_list": [ - "Dengue", - "Disease Progression" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Age >3 months and <16 years \n\n Clinical suspicion of dengue hemorrhagic fever. (Revised WHO Classification System) \n\n Not a prisoner or ward of the state \n\n Parents able and willing to give consent. Children older then 7 able and willing to give assent \n\n ", - "exclusion_criteria": ": \n\n Allergic to Ultrasound gel \n\n Prisoners or wards of the state \n\n Unstable patients \n\n Known pleural effusion, ascites, or gallbladder wall thickening.", - "brief_summary": "The purpose of this study is determine the ability of bedide ultrasound performed in the Emergency Department and Outpatient Department can predict the severity of disease during a Dengue Fever outbreak in children, in Siem Reap, Cambodia. Our hypothesis is that the presence of gallbladder wall thickening and/or pleural effusions in children correlates with progression to Dengue hemorrhagic fever and Dengue shock. In addition, we hypothesize that sonographic imaging of pediatric patients presenting to the emergency department with a fever during a Dengue fever outbreak will change management and disposition.", - "NCTID": "NCT02134652" - }, - { - "brief_title": "Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Dengue', 'Dengue Fever', 'Dengue Hemorrhagic Fever']", - "diseases_list": [ - "Dengue", - "Dengue Fever", - "Dengue Hemorrhagic Fever" - ], - "enrollment": "3203.0", - "inclusion_criteria": "inclusion criteria: \n\n Ongoing participation in study CYD23 at the time of enrolment. \n\n Assent form was signed and dated by the participant (for participants >= 7 years old), and informed consent form was signed and dated by the parent(s) or another legally accepted representative and by 2 independent witnesses. \n\n Participant and parent/legally accepted representative were able to attend all scheduled visits to comply with all study procedures. \n\n ", - "exclusion_criteria": ": \n\n Planned participation in another dengue clinical trial during the present study \n\n Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.", - "brief_summary": "The purpose of this study was to conduct a passive surveillance of hospitalized dengue cases in participants who participated in study CYD23 (NCT00842530).~The Objectives:~To describe the incidence of virologically-confirmed hospitalized dengue cases.~To characterize hospitalized dengue cases.~To evaluate the occurrence of related and fatal serious adverse events (SAEs).", - "NCTID": "NCT01983553" - }, - { - "brief_title": "The Clinical Epidemiology of Hospitalized Dengue Cases in Malaysia", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Dengue Fever']", - "diseases_list": [ - "Dengue Fever" - ], - "enrollment": "322.0", - "inclusion_criteria": "inclusion criteria: \n\n Stage 1: \n\n Discharge diagnosis with International Classification of Disease (ICD) code A90 - A99 \n\n Availability of minimal dataset (name, IC, age, sex, diagnosis, date admit, date discharge, discharge status) \n\n Stage 2: \n\n Laboratory confirmed dengue (Non-structural 1 antigen, dengue IgM, high-titre dengue IgG, and dengue polymerase chain reaction (PCR) positive) \n\n ", - "exclusion_criteria": ": \n\n Nil", - "brief_summary": "Dengue infection has been identified as the fastest spreading mosquito-borne viral disease by World Health Organization (WHO), which affects more than 2.5 billion people living in the subtropical and tropical regions. Malaysia is hyper-endemic with all four dengue virus serotypes circulating and responsible for the escalating number of cases over the years. As of 28 February 2015, there are 62 deaths secondary to dengue infection being reported in Malaysia; and the total number of dengue cases reported in the same period was 23,966 which is 46% higher than the same reporting period of 2014. Although dengue virus has been identified for so many years and plenty of research work has been carried out, it was proven that there are still many aspects that we are not too sure about the disease. Therefore, this multi-center, observational cohort study is designed to investigate the clinical course of hospitalized dengue infection in Malaysia. The study population of this study consists of male or female patients with dengue to be randomly sampled from hospitals in Malaysia. This study will be conducted in 2 stages whereby the 1st stage will only focus on the basic social and clinical data to describe the clinical course of dengue as general and the 2nd stage will collect the more detailed clinical and management data to describe the detailed clinical course, management and prognosis of dengue. All hospital participation in this study is voluntary, and approval will be obtained from National Institute of Health (NIH) and Medical Research Ethics Committee (MREC) prior to any recruitment.", - "NCTID": "NCT02510638" - }, - { - "brief_title": "Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy Toddlers", - "phase": "Phase 3", - "drugs": "['Live, attenuated dengue serotype 1, 2, 3, and 4 virus', 'Yellow fever vaccine', 'Measles, mumps, and rubella (MMR) vaccine', 'Pneumococcal Conjugated Vaccine', 'Hepatitis A Pediatric Vaccine', 'Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine', 'Live, attenuated dengue serotype 1, 2, 3, and 4 virus', 'Yellow Fever Vaccine', 'Placebo (NaCl)', 'Measles, mumps, and rubella vaccine', 'Pneumococcal Conjugated Vaccine', 'Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine', 'Hepatitis A Pediatric Vaccine']", - "drugs_list": [ - "Live", - "attenuated dengue serotype 1", - "2", - "3", - "and 4 virus", - "Yellow fever vaccine", - "Measles", - "mumps", - "and rubella (MMR) vaccine", - "Pneumococcal Conjugated Vaccine", - "Hepatitis A Pediatric Vaccine", - "Diphtheria", - "tetanus", - "pertussis", - "polio", - "and Haemophilus influenzae vaccine", - "Live", - "attenuated dengue serotype 1", - "2", - "3", - "and 4 virus", - "Yellow Fever Vaccine", - "Placebo (NaCl)", - "Measles", - "mumps", - "and rubella vaccine", - "Pneumococcal Conjugated Vaccine", - "Diphtheria", - "tetanus", - "pertussis", - "polio", - "and Haemophilus influenzae vaccine", - "Hepatitis A Pediatric Vaccine" - ], - "diseases": "['Dengue', 'Dengue Hemorrhagic Fever', 'Yellow Fever']", - "diseases_list": [ - "Dengue", - "Dengue Hemorrhagic Fever", - "Yellow Fever" - ], - "enrollment": "792.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged 12 to 13 months on the day of inclusion. \n\n Born at full term of pregnancy (>=37 weeks) and with a birth weight >=2.5 kg as reported by the parent/legally acceptable representative. \n\n Participant in good health, based on medical history and physical examination. \n\n Participant had completed his/her vaccination schedule according to the official immunization calendar of Colombia and/or Peru, respectively. \n\n Informed consent form had been signed and dated by the parent(s) or other legally acceptable representative (and by 2 independent witnesses if required by local regulations). \n\n Participant and parent/legally acceptable representative/tutor able to attend all scheduled visits and to comply with all trial procedures. \n\n ", - "exclusion_criteria": ": \n\n Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination. \n\n Planned participation in another clinical trial during the present trial period. \n\n Planned receipt of any vaccine in the 4 weeks following first trial vaccination. \n\n Previous vaccination against YF, hepatitis A, or measles, mumps and rubella. \n\n Receipt of blood or blood-derived products in the past 3 months which might interfere with assessment of the immune response. \n\n Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 weeks or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). \n\n Personal known seropositivity for human immunodeficiency virus (HIV) as reported by the parent/legally acceptable representative. \n\n History of previous maternal vaccination against YF as reported by the parent/legally acceptable representative. \n\n Personal history of YF or dengue infection/disease as reported by the parent/legally acceptable representative. \n\n Known systemic hypersensitivity to any of the vaccine components of the vaccines that were used in the trial, or history of a life-threatening reaction to the vaccines used in the trial or to vaccines containing any of the same substances. \n\n History of contraindication to receipt of vaccines containing components of Stamaril\u00ae (yellow fever vaccine), measles, mumps and rubella vaccine, hepatitis A vaccine, pneumococcal conjugated vaccine or of diphtheria (D) toxoid, tetanus (T) toxoid, pertussis toxoid (PT), filamentous hemagglutinin (FHA), polyribosylribitol phosphate (PRP) and polio or other diphtheria, tetanus and pertussis vaccine (e.g., DTwP). \n\n Thrombocytopenia, as reported by the parent/legally acceptable representative. \n\n Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular (IM) vaccination. \n\n History of central nervous system disorder or disease, including seizures. \n\n Personal history of thymic pathology (e.g., thymoma), and/or thymectomy. \n\n Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion. \n\n Identified as a child (adopted or natural) of the Investigator or of employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center.", - "brief_summary": "The study was designed to evaluate whether the first CYD dengue vaccination can be administered concomitantly with Stamaril\u00ae yellow fever vaccine during the same day and visit, but at 2 different sites of administration.~Primary Objective:~To demonstrate the non-inferiority of the immune response against Yellow Fever (YF) in flavivirus (FV) non-immune subjects at baseline receiving one dose of Stamaril vaccine administered concomitantly with the first dose of CYD dengue vaccine compared to participants receiving one dose of Stamaril vaccine concomitantly with placebo.~Secondary Objectives:~To assess the non-inferiority of YF immune response 28 days post-Stamaril vaccination based on seroconversion rates regardless of the FV status of participants at baseline.~To describe the YF immune response 28 days post-Stamaril vaccination in both groups.~To describe the antibody (Ab) response to each dengue virus serotype 28 days post CYD dengue vaccine (Visit [V] 05 and V07), following CYD dengue vaccine Dose 1 and Dose 2 from Group 2 versus following CYD dengue vaccine Dose 2 and Dose 3 for Group 1 (effect of YF vaccination).~To describe the safety of Stamaril vaccine administered concomitantly with the first dose of CYD dengue vaccine, or Stamaril administered concomitantly with placebo.~To describe the safety of CYD dengue vaccine after the first dose of CYD dengue vaccine administered concomitantly with Stamaril vaccine or CYD vaccine administered alone.~To describe the safety of the CYD dengue vaccine in all participants after each dose.", - "NCTID": "NCT01436396" - }, - { - "brief_title": "Safety of and Immune Response to a Dengue Virus Vaccine (rDEN1delta30) in Healthy Adults", - "phase": "Phase 1", - "drugs": "['rDEN1delta30', 'Placebo']", - "drugs_list": [ - "rDEN1delta30", - "Placebo" - ], - "diseases": "['Dengue Fever']", - "diseases_list": [ - "Dengue Fever" - ], - "enrollment": "28.0", - "inclusion_criteria": "inclusion criteria: \n\n Willing to be followed for the duration of the study \n\n Willing to use acceptable methods of contraception \n\n Good general health \n\n ", - "exclusion_criteria": ": \n\n Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease \n\n Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study \n\n Liver, renal, or hematologic disease \n\n Alcohol or drug abuse within 12 months of study entry \n\n History of severe allergic reaction or anaphylaxis \n\n Emergency room visit or hospitalization for severe asthma within 6 months of study entry \n\n HIV-1 infected \n\n HCV infected \n\n Hepatitis B surface antigen positive \n\n Known immunodeficiency syndrome \n\n Use of corticosteroids or immunosuppressive drugs within 30 days of study entry. Participants who have used topical or nasal corticosteroids are not excluded. \n\n Live vaccine within 4 weeks of study entry \n\n Killed vaccine within 2 weeks of study entry \n\n Blood products within 6 months of study entry \n\n Investigational drugs or vaccines within 60 days prior to study entry or while currently enrolled in this clinical trial \n\n Previously received a licensed or experimental yellow fever or dengue vaccine \n\n Surgical removal of spleen \n\n History of dengue virus infection or other flavivirus infection \n\n Other condition that, in the opinion of the investigator, would affect the participant's participation in the study \n\n Pregnancy or breastfeeding \n\n Plan to travel to an area where dengue infection is common", - "brief_summary": "Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and subtropical regions of the world. The purpose of this study is to test the safety of and immune response to a new dengue virus vaccine in healthy adults.", - "NCTID": "NCT00089908" - }, - { - "brief_title": "Safety of and Immune Response to Two Different Dengue Virus Vaccines in Individuals Previously Immunized Against Dengue Virus", - "phase": "Phase 1", - "drugs": "['rDEN1delta30', 'rDEN2/4delta30(ME)', 'Placebo to rDEN1delta30 or rDEN2/4delta30(ME)']", - "drugs_list": [ - "rDEN1delta30", - "rDEN2/4delta30(ME)", - "Placebo to rDEN1delta30 or rDEN2/4delta30(ME)" - ], - "diseases": "['Dengue Hemorrhagic Fever']", - "diseases_list": [ - "Dengue Hemorrhagic Fever" - ], - "enrollment": "36.0", - "inclusion_criteria": "inclusion criteria: \n\n Previous vaccination with rDEN1delta30, rDEN2/4delta30(ME), OR rDEN4delta30 vaccine \n\n General good health \n\n Available for the duration of the study \n\n Willing to use accepted forms of contraception \n\n ", - "exclusion_criteria": ": \n\n Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease by history, physical examination, or laboratory studies including urinalysis \n\n Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study \n\n Certain abnormal laboratory values \n\n Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months of study entry \n\n History of severe allergy or anaphylaxis \n\n Severe asthma requiring an emergency room visit or hospitalization within 6 months of study entry \n\n HIV infected \n\n Hepatitis C virus infected \n\n Hepatitis B surface antibody positive \n\n Known immunodeficiency syndrome \n\n Use of corticosteroids or immunosuppressive drugs 30 days prior to study entry. Participants who have used topical or nasal corticosteroids are not excluded. \n\n Receipt of live vaccine within 4 weeks of study entry \n\n Receipt of killed vaccine within 2 weeks of study entry \n\n Absence of spleen \n\n Plan to travel to an area where dengue virus is common \n\n Any investigational product within 30 days of study entry \n\n Other condition that, in the opinion of the investigator, would interfere with the study \n\n Pregnancy or breastfeeding", - "brief_summary": "Dengue fever, which is caused by dengue viruses, is a major health problem in subtropical regions of the world. There are four different forms (serotypes) of dengue virus that can cause dengue fever. The purpose of this study is to determine the safety and immune response to a vaccine containing a particular dengue serotype when an individual has been previously vaccinated with a different dengue serotype.", - "NCTID": "NCT00458120" - }, - { - "brief_title": "Efficacy and Safety of Dengue Vaccine in Healthy Children", - "phase": "Phase 2", - "drugs": "['CYD Dengue Vaccine', 'Inactivated rabies virus vaccine', 'Placebo']", - "drugs_list": [ - "CYD Dengue Vaccine", - "Inactivated rabies virus vaccine", - "Placebo" - ], - "diseases": "['Dengue Virus', 'Dengue Fever', 'Dengue Hemorrhagic Fever', 'Dengue Diseases']", - "diseases_list": [ - "Dengue Virus", - "Dengue Fever", - "Dengue Hemorrhagic Fever", - "Dengue Diseases" - ], - "enrollment": "4002.0", - "inclusion_criteria": "inclusion criteria : \n\n Aged 4 to 11 years on the day of inclusion. \n\n Participant in good health, based on medical history and physical examination. \n\n Provision of assent form signed by the participants (for participants >= 7 years old) and informed consent form signed by the parent or another legally acceptable representative. \n\n Participant and parent/ legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures. \n\n Participant attended one of the schools involved in the trial and living in the Ratchaburi Province. \n\n For a female participant of child-bearing potential (girls post-menarche), avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination, until at least 4 weeks after the last vaccination. \n\n ", - "exclusion_criteria": " : \n\n Febrile illness (temperature >= 37.5\u00b0C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment. \n\n For a female participant of child-bearing potential (girls post-menarche), known pregnancy or positive urine pregnancy test on the day of the first trial vaccination. \n\n Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia. \n\n Planned participation in another clinical trial during the present trial period. \n\n Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or long-term systemic corticosteroids therapy. \n\n Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances. \n\n Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator. \n\n Receipt of blood or blood-derived products in the past 3 months. \n\n Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. \n\n Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination. \n\n Receipt of any vaccine in the 4 weeks preceding the first trial vaccination. \n\n Planned receipt of any vaccine in the 4 weeks following the first trial vaccination.e \n\n Participant who plans to attend another school (outside the trial area) or move to another city in the coming 30 months.", - "brief_summary": "The primary objective of the study was to assess the efficacy of CYD dengue vaccine after three injections in preventing symptomatic virologically-confirmed dengue (VCD) cases, regardless of the severity, due to any of the four serotypes in children aged 4 to 11 years at the time of inclusion.~Secondary objectives included to assess:~Vaccine efficacy against severe VCD cases~Vaccine efficacy against VCD cases following at least two injections with CYD dengue vaccine~Immune response to CYD dengue vaccine~Safety profile of CYD dengue vaccine. Safety assessments include solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period.~Other objectives included:~Vaccine efficacy against VCD cases following at least one injection with CYD dengue vaccine~Vaccine efficacy against VCD cases due to each serotype~Participants with clinical signs and symptoms for VCD", - "NCTID": "NCT00842530" - }, - { - "brief_title": "Study of ChimeriVax\u2122 Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years", - "phase": "Phase 2", - "drugs": "['CYD Dengue Vaccine Serotypes 1, 2, 3, and 4', 'Pneumococcal polysaccharide vaccine']", - "drugs_list": [ - "CYD Dengue Vaccine Serotypes 1", - "2", - "3", - "and 4", - "Pneumococcal polysaccharide vaccine" - ], - "diseases": "['Dengue Virus', 'Dengue Fever', 'Dengue Hemorrhagic Fever', 'Dengue Diseases']", - "diseases_list": [ - "Dengue Virus", - "Dengue Fever", - "Dengue Hemorrhagic Fever", - "Dengue Diseases" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria : \n\n Aged 2 to 11 years on the day of inclusion. \n\n Participant in good health, based on medical history, physical examination and laboratory parameters. \n\n Provision of Assent Form signed by the participants (for participants >=8 years old) and Informed Consent Form signed by the parents or another legally acceptable representative (and by an independent witness for illiterate parent[s]). \n\n Participant and parents/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures. \n\n For a female participant of child-bearing potential (girls post-menarche), avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination, until at least 4 weeks after the last vaccination. \n\n Documented receipt of yellow fever vaccine since at least one month before the first vaccination. \n\n ", - "exclusion_criteria": " : \n\n Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia. \n\n For a female participant of child-bearing potential (girls post-menarche), known pregnancy. \n\n For a female participant of child-bearing potential (girls post-menarche), known pregnancy or positive pregnancy test in blood sample taken at Screening. \n\n Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination. \n\n Planned participation in another clinical trial during the trial. \n\n Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy. \n\n Known systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances. \n\n Systemic hypersensitivity to YF vaccine or history of a life-threatening reaction to YF vaccine. \n\n Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator. \n\n Current or past alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures. \n\n Receipt of any blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response. \n\n Receipt of any vaccine in the 4 weeks preceding the first trial vaccination. \n\n Planned receipt of any vaccine in the 4 weeks following the first trial vaccination. \n\n Human Immunodeficiency Virus, hepatitis B antigen, or hepatitis C seropositivity in blood sample taken at Screening. \n\n Clinically significant laboratory abnormalities (as determined by the Investigator) in blood sample taken at Screening. \n\n Known previous vaccination with pneumococcal polysaccharide vaccine.", - "brief_summary": "The aim of the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine, against dengue disease.~Primary Objectives:~To describe the humoral immune response to dengue before and after each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years) previously vaccinated with yellow fever (YF) vaccine.~To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years).~To describe viremia after the first and second vaccinations with dengue vaccine in a subgroup of 130 randomized participants (100 participants in Dengue Vaccine Group and 30 participants in Control Group) in two age cohorts of children (6 to 11 years and 2 to 5 years).", - "NCTID": "NCT00788151" - }, - { - "brief_title": "Study of a Booster Dose of a Tetravalent Dengue Vaccine in Subjects Who Previously Completed the 3-dose Schedule", - "phase": "Phase 2", - "drugs": "['CYD Dengue Vaccine (5-dose formulation)', 'Placebo, NaCl 0.9%']", - "drugs_list": [ - "CYD Dengue Vaccine (5-dose formulation)", - "Placebo", - "NaCl 0.9%" - ], - "diseases": "['Dengue Fever', 'Dengue Hemorrhagic Fever']", - "diseases_list": [ - "Dengue Fever", - "Dengue Hemorrhagic Fever" - ], - "enrollment": "251.0", - "inclusion_criteria": "inclusion criteria: \n\n Had been identified as a potential participant by the Sponsor and is included in the list provided to the Investigator (i.e., aged 9 to 16 years on the day of first vaccination of CYD dengue vaccine in CYD13/CYD30 and has a post-dose 3 serum sample available [at least 400 microliters of serum]). \n\n Participants were in good health, based on medical history and physical examination. \n\n Assent form or informed consent form (ICF) had been signed and dated by the participant (based on local regulations), and ICF had been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations). \n\n Participant and parent(s)/legally acceptable representative(s) attended all scheduled visits and complied with all trial procedures. \n\n ", - "exclusion_criteria": ": \n\n Participant who received any other dengue vaccination that was not part of the CYD13 or CYD30 trials. \n\n Participant was pregnant, or lactating, or of childbearing potential (to be considered of non childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination). \n\n Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. \n\n Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination. \n\n Receipt of immune globulins, blood or blood-derived products in the past 3 months. \n\n Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). \n\n Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances. \n\n Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion. \n\n Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response. \n\n Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. \n\n Current alcohol abuse or drug addiction. \n\n Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature >= 38.0\u00b0C). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided. \n\n Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.", - "brief_summary": "The aim of the study was to assess and describe the booster effect of a CYD dengue vaccine dose administered 4 to 5 years after the completion of a 3-dose vaccination schedule.~Primary Objective~- To demonstrate the non-inferiority, in terms of geometric mean of titer ratios (GMTRs), of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD13 - NCT00993447 and CYD30 - NCT01187433 trials (participants from Group 1 only).~Secondary Objectives:~If the primary objective of non-inferiority was achieved: To demonstrate the superiority, in terms of GMTRs, of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD13 and CYD30 trials.~To describe the immune responses elicited by a CYD dengue vaccine booster and placebo injection in participants who received 3 doses of the CYD dengue vaccine in the CYD13 and CYD30 trials in all participants.~To describe the neutralizing antibody levels of each dengue serotype post-dose 3 (CYD13 and CYD30 participants) and immediately prior to booster or placebo injection in all participants.~To describe the neutralizing antibody persistence 6 months, 1 year, and 2 years post booster or placebo injection in all participants.~To evaluate the safety of booster vaccination with the CYD dengue vaccine in all participants.", - "NCTID": "NCT02623725" - }, - { - "brief_title": "Safety of and Immune Response of a 2-dose Regimen of rDEN1delta30 Dengue Virus Vaccine", - "phase": "Phase 1", - "drugs": "['rDEN1delta30', 'Placebo']", - "drugs_list": [ - "rDEN1delta30", - "Placebo" - ], - "diseases": "['Dengue']", - "diseases_list": [ - "Dengue" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Good general health \n\n Available for the duration of the study (23 weeks for Cohort 1 and 32 weeks for Cohort 2) \n\n Willing to use acceptable forms of contraception for the duration of the study \n\n ", - "exclusion_criteria": ": \n\n Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease \n\n Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study \n\n Significant laboratory abnormalities \n\n Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months prior to study entry \n\n History of severe allergic reaction or anaphylaxis \n\n Severe asthma \n\n HIV-1 infected \n\n Hepatitis C virus (HCV) infected \n\n Hepatitis B surface antigen positive \n\n Known immunodeficiency syndrome \n\n Use of corticosteroids or immunosuppressive medications within 30 days prior to study entry. Individuals using topical or nasal corticosteroids are not excluded. \n\n Previous receipt of a live vaccine within 4 weeks prior to study entry \n\n Previous receipt of a killed vaccine within 2 weeks prior to study entry \n\n Absence of spleen \n\n Previous receipt of blood products within 6 months prior to study entry \n\n Previous receipt of dengue virus or other flavivirus (e.g., yellow fever virus, St.Louis encephalitis, West Nile virus) infection \n\n Previous receipt of yellow fever or dengue vaccine \n\n Plans to travel to an area where dengue infection is common \n\n Previous receipt of any investigational agent within 30 days prior to study entry \n\n Other condition that, in the opinion of the investigator, would affect participation in the study \n\n Pregnant or breastfeeding", - "brief_summary": "Dengue fever, caused by dengue viruses, is a major health problem in tropical and subtropical regions of the world. The purpose of this study is to evaluate the safety of and immune response to a 2-dose regimen of a new monovalent dengue virus vaccine. This study will test the dengue virus vaccine DEN1delta30 in healthy adults.", - "NCTID": "NCT00473135" - }, - { - "brief_title": "Tetravalent Chimeric Dengue Vaccine Trial", - "phase": "Phase 1", - "drugs": "['Placebo (SC)', 'Placebo (ID)', 'Modified Live Tetravalent Chimeric Dengue Vaccine (SC)', 'Modified Live Tetravalent Chimeric Dengue Vaccine (ID)']", - "drugs_list": [ - "Placebo (SC)", - "Placebo (ID)", - "Modified Live Tetravalent Chimeric Dengue Vaccine (SC)", - "Modified Live Tetravalent Chimeric Dengue Vaccine (ID)" - ], - "diseases": "['Dengue']", - "diseases_list": [ - "Dengue" - ], - "enrollment": "72.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female at least 18 and less than or equal to 45 years old at time of screening. \n\n In good health as determined by medical history, physical examination including height and weight, and clinical safety laboratory examinations. For creatinine and alkaline phosphatase levels the applicable cut-offs for determination are the upper limits of normal only, as there is no clinical significance associated with results below the lower limits of normal for these laboratory values. For aspartate aminotransferase (AST) and alanine aminotransferase (ALT), the applicable cut-offs for determination are less than 1.5 times the upper limits of normal, as there is no clinical significance associated with results below the lower limits of normal for these laboratory values or with mild elevations above the upper limits of normal. \n\n Laboratory values not listed in Table 3 which are obtained as part of a reference laboratory pre-determined panel will be considered as acceptable for enrollment if they are either within reference laboratory normal range or within the ranges specified for a grade I AE per the protocol Toxicology Tables in Appendix B. Values within reference laboratory normal ranges or within ranges specified for a grade I AE per the Toxicology Tables in Appendix B will be considered as discussed with the medical monitor and may be enrolled with no further discussion. Values with deviations outside the ranges specified for a grade 1 AE in the Toxciology Tables in Appendix B will be discussed further between the PI and the medical monitor prior to vaccination and assessed for impact on volunteer safety. Urinalyses obtained from female volunteers on their menses may be repeated after their menses have concluded without discussion with the medical monitor. Laboratory values which are not listed in the Toxicology Tables in Appendix B and which are out of the reference laboratory normal range will be discussed with the DMID medical monitor to determine its relevance for safety and impact on enrollment and follow-up vaccinations. \n\n Blood tests negative for antibodies to human immunodeficiency virus (HIV)-1, Hepatitis C, dengue, West Nile, and negative for Hepatitis B surface antigen. \n\n No history of dengue or West Nile infection or participation in a previous dengue or West Nile vaccine trial. \n\n Females of child bearing potential must have a negative urine pregnancy test result during screening and a negative urine pregnancy test immediately prior to vaccination and be willing to use oral, implantable, transdermal or injectable contraceptives or another reliable means of contraception approved by the Investigator (intrauterine device, female condom, diaphragm with spermicidal, cervical cap, use of condom by the sexual partner or a sterile sexual partner, or abstinence) from screening until after the last blood sample (at day 270). \n\n Willing and able to give written informed consent to participate. \n\n Willing and able to communicate with the investigator and understand the requirements of the study. \n\n Electrocardiogram (ECG) in absence of clinical significance (e.g., complete left or right bundle branch block, incomplete left bundle branch block or sustained ventricular arrhythmia, or two premature ventricular contraction's (PVC's) in a row, or ST elevation consistent with ischemia). \n\n Weight: greater than or equal to 110 lb. \n\n Access to a fixed or mobile telephone. \n\n ", - "exclusion_criteria": ": \n\n Any condition which would limit the subject's ability to complete the study in the opinion of the Investigator. \n\n Clinically significant hematological, renal, hepatic, pulmonary, central nervous, cardiovascular, thromboembolic, autoimmune, coagulopathic, or gastrointestinal disorders or history of such disorders \n\n Any history of malignancy with the exception of basal cell carcinoma. \n\n Previous history , or current diagnosis of diabetes mellitus. \n\n Pulse >95 or <40 at rest or irregular, systolic blood pressure (bp) >170 or <90 at rest or diastolic bp >90 or <50 at rest, body temperature >100 F, respirations >25 per minute at rest. \n\n History of allergy to penicillin, neomycin, streptomycin or gentamicin. \n\n History of hypersensitivity to any vaccine. \n\n History of previous vaccination with Yellow Fever (YF) vaccine or Japanese Encephalitis (JE) vaccine or planned receipt of either YF or JE vaccine during the course of the study. \n\n Previous history of infection with dengue or West Nile or seropositive antibody status to dengue or West Nile virus or participation in a vaccine trial for either of these. \n\n Travel or planned travel to a dengue-endemic area including the Caribbean, Mexico, Central America, South America or Asia during the study period or in the month prior to screening. An updated map of dengue endemic areas is available at the CDC Yellow Book 2010 website (http://wwwnc.cdc.gov/travel/yellowbook/2010/chapter-5/dengue-fever-dengue-hemorrhagic-fever.aspx) and a list of dengue endemic countries is provided in the Manual of Procedures (MOP). \n\n Travel to a dengue endemic area within 1 month of screening. Volunteers who have a history of recent travel to a dengue endemic area may screen if they have returned to the US 30 or more days prior to the screening visit. \n\n Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 0.5 mg/kg/day). Intranasal or topical prednisone (or equivalent) are allowed. \n\n Personal history of recurring migraines or on prescription medication for treatment of recurring headaches or migraines. \n\n Use of any non-steroidal anti-inflammatory drugs (NSAIDs), including any aspirin-containing products, acetaminophen or systemic, topical, or intranasal antihistamines for the 3 days immediately prior to each vaccination. Systemic antihistamines may not be used at all during the first 21 days after each vaccination. \n\n During the first 14 days after each vaccination, anti-inflammatory drugs (NSAIDs) or acetaminophen may be used only if the subject has a fever >/= 100 F or if the subject has significant arm pain, myalgia, arthralgia, or headache and only after documenting the symptom in the memory aid. Intranasal or topical antihistamines may be used during the first 14 days after each vaccination only if the subject has significant allergy symptoms such as rhinitis, cough, eye inflammation, or pruritis and only after documenting the symptom in the memory aid. Intranasal or topical antihistamines, NSAIDs or acetaminophen should only be taken after documentation of symptoms or fever in the memory aid and should not be taken prophylactically. \n\n Receipt of any other investigational product in the month before study entry and during the entire study duration. \n\n Receipt or planned receipt of any licensed vaccine in the 4 weeks preceding either trial vaccination (2 weeks for inactivated vaccines) or planned receipt of any vaccine in the 4 weeks following each of the trial vaccinations. \n\n Concurrent or planned participation in any other clinical study during the conduct of this study. \n\n Receipt of blood products or immunoglobulins 8 weeks before study entry or planned use during the study period. \n\n Donation of blood 6 weeks before study entry or at any time during the study. \n\n Laboratory screening test result that is not within protocol specified normal range (Table 3 of protocol). \n\n Females who are pregnant or lactating.", - "brief_summary": "The purpose of this study is to test the safety and immune response to a live attenuated dengue vaccine that could protect people against all 4 types of dengue virus. Live attenuated means that while this vaccine contains 4 live dengue viruses the viruses have been attenuated (weakened) so as not to cause dengue disease in people. Dengue virus is spread to people by mosquitoes and can cause sickness and even death. Seventy-two subjects between the ages of 18-45 years old will be enrolled in this research study at Saint Louis University Center for Vaccine Development. Participants will be randomly assigned to 1 of 4 groups to receive 2 doses of the study vaccine or placebo (inactive substance). Study procedures include: maintaining a diary to record temperature and side effects, physical exam, electrocardiogram (ECG) (measures the activity of the heart), and blood samples. Participants will be involved in study related procedures for about 10 months.", - "NCTID": "NCT01110551" - }, - { - "brief_title": "A Cohort Study to Determine the Incidence of Dengue Fever and to Build Capacity for Dengue Vaccine Trials in Dengue-endemic Regions of South Asia", - "phase": "", - "drugs": "['Blood sample collection']", - "drugs_list": [ - "Blood sample collection" - ], - "diseases": "['Dengue']", - "diseases_list": [ - "Dengue" - ], - "enrollment": "2004.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject and/or subject's parent(s)/legally acceptable representative(s) (LAR[s]) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. (e.g., willingness to go to the hospital/clinic for visit[s] in case of AFI, able to observe the signs of dengue and to understand how to take and report body temperature, etc.). \n\n Signed/thumb-printed (and video recorded if required by law) informed consent (and assent if applicable) must be obtained from the subject/subject's parent(s)/LAR(s) at the hospital/clinic or during a home visit. If the subject/subject's parent(s)/LAR(s) are illiterate, the informed consent form (ICF) (or informed assent form [IAF] when applicable) will be countersigned by an impartial witness. \n\n Subject is part of a household with at least one child (aged less than 18 years) and in which informed consent (and assent if applicable) to study participation was obtained from at least one adult and one child. \n\n Male or female aged between and including 6 months and 50 years at the time of enrolment. \n\n Subject who plans, at the time of enrolment, to remain at same residence/study area during the two-year study period. \n\n ", - "exclusion_criteria": ": \n\n Child in care. \n\n Participation (current or planned) in another epidemiological study or in a clinical trial that would conflict with the current study, based on investigator's judgement. \n\n Terminal illness based on investigator's judgement. \n\n Mental incapacity based on investigator's judgement.", - "brief_summary": "The purpose of this study is to determine the incidence of dengue fever and to build capacity for dengue vaccine trials in dengue-endemic regions of South Asia.", - "NCTID": "NCT02570152" - }, - { - "brief_title": "Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US", - "phase": "Phase 2", - "drugs": "['Tetravalent CYD Dengue Vaccine , 5555 formulation', 'Tetravalent CYD Dengue Vaccine , 5553 formulation', 'Tetravalent CYD Dengue Vaccine, 4444 formulation']", - "drugs_list": [ - "Tetravalent CYD Dengue Vaccine ", - "5555 formulation", - "Tetravalent CYD Dengue Vaccine ", - "5553 formulation", - "Tetravalent CYD Dengue Vaccine", - "4444 formulation" - ], - "diseases": "['Dengue Fever', 'Dengue Hemorrhagic Fever', 'Dengue Virus']", - "diseases_list": [ - "Dengue Fever", - "Dengue Hemorrhagic Fever", - "Dengue Virus" - ], - "enrollment": "260.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy, as determined by medical history, clinical examination, and biological safety parameters. \n\n Aged 18 to 45 years on the day of inclusion. \n\n Provision of informed consent signed by the participant or another legally acceptable representative. \n\n For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, and until at least 4 weeks after the last study vaccination. \n\n Able to attend all scheduled visits and to comply with all trial procedures. \n\n ", - "exclusion_criteria": ": \n\n Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia. \n\n For a woman of child-bearing potential, known or suspected pregnancy or positive serum/urine pregnancy test. \n\n Breast-feeding woman. \n\n Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination. \n\n Planned participation in another clinical trial during the present trial period. \n\n Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 10 mg). Topical steroids were allowed. \n\n Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances. \n\n Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator. \n\n Current or past alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures. \n\n Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response. \n\n Receipt of any vaccine in the 4 weeks preceding the first trial vaccination. \n\n Planned receipt of any vaccine in the 4 weeks following each of the trial vaccinations. \n\n Human Immunodeficiency Virus (HIV), hepatitis B surface antigen, or hepatitis C virus seropositivity in blood sample taken at Screening. \n\n Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. \n\n Clinically significant laboratory test abnormalities (as determined by the investigator) in blood sample taken at Screening. \n\n Previous residence in, travel or planned travel of more than 2 weeks during the study period to areas with high dengue infection endemicity. \n\n Reported history of flavivirus infection as reported by the participant. \n\n Previous vaccination against flavivirus diseases (including Japanese encephalitis, tick-borne encephalitis, and yellow fever). \n\n Flavivirus vaccination planned during the trial period.", - "brief_summary": "This study used 3 different formulations of tetravalent CYD dengue vaccine.~The primary objective of the study was to evaluate the neutralizing antibody response after 2 doses of two different formulations of tetravalent dengue vaccine administered at Month 0 and Month 6.~The secondary objectives were:~To evaluate the safety of the 3 formulations of tetravalent CYD dengue vaccine.~To describe the neutralizing antibody responses to each of the 3 vaccine formulations.~To describe vaccine viremia after the first and second dose of each of the 3 vaccine formulations in a subset of participants.", - "NCTID": "NCT00617344" - }, - { - "brief_title": "Evaluation of the Safety and the Ability of a DNA Vaccine to Protect Against Dengue Disease", - "phase": "Phase 1", - "drugs": "['Tetravalent Dengue Vaccine (TVDV)', 'Tetravalent Dengue Vaccine (TVDV) with Vaxfectin\u00ae (low-dose)', 'Tetravalent Dengue Vaccine TVDV with Vaxfectin\u00ae (High Dose)']", - "drugs_list": [ - "Tetravalent Dengue Vaccine (TVDV)", - "Tetravalent Dengue Vaccine (TVDV) with Vaxfectin\u00ae (low-dose)", - "Tetravalent Dengue Vaccine TVDV with Vaxfectin\u00ae (High Dose)" - ], - "diseases": "['Dengue Disease', 'Dengue Fever']", - "diseases_list": [ - "Dengue Disease", - "Dengue Fever" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female age 18 to 50 (inclusive) years old at the time of enrollment \n\n Have negative anti-dengue, Japanese encephalitis, West Nile, and yellow fever ELISA serological tests \n\n Be informed of the nature of the study and provide written informed consent \n\n If the subject is of child-producing potential, he/she agrees to practice adequate birth control or abstain from sex \n\n Have access to the WRAIR Clinical Trials for at least 270 days, and be willing to refrain from participation in other investigational clinical trials \n\n Be in good general health \n\n ", - "exclusion_criteria": "-Subjects meeting any of the following criteria will be excluded from the study: \n\n History of Flavivirus infection or history of Flavivirus vaccine (experimental or licensed product) including Japanese encephalitis, yellow fever, and dengue \n\n Have a known or suspected hypersensitivity or adverse reaction to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain \n\n Have received a live-attenuated vaccine within 42 days prior to the initial injection on Day 0 or a subunit or killed vaccine within 30 days of the initial injection on Day 0 \n\n Have a positive screen for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or HIV antibody \n\n Are pregnant or breastfeeding \n\n Have donated or received blood, blood products, or plasma within 30 days prior to Day 0 \n\n Have any acute illness, including an oral body temperature >100.4\u00b0F, within 7 days before the initial injection on Day 0 \n\n Have a past or current history of malignant disease except for adequately treated skin cancer \n\n Exclusions include but are not limited to conditions pertaining to or evidence of immunodeficiency; allergies requiring treatment with antigen injections; autoimmune disease; severe migraine headaches; unstable asthma; clinically significant cardiac arrhythmias, diabetes mellitus, thyroid disease, a bleeding disorder or a seizure disorder. \n\n Have participated in an investigational drug, vaccine, or device study within a period of 30 days prior to Day 0; \n\n History of splenectomy \n\n Planned travel to dengue endemic areas during the study period", - "brief_summary": "The purpose of this study is to determine whether a new investigational dengue vaccine is safe, well-tolerated, and to see if an immune response against dengue disease will be generated.", - "NCTID": "NCT01502358" - }, - { - "brief_title": "Chikungunya Virus Vaccine Trial in Healthy Adults", - "phase": "Phase 1", - "drugs": "['VRC-CHKVLP059-00-VP']", - "drugs_list": [ - "VRC-CHKVLP059-00-VP" - ], - "diseases": "['Viral Vaccines', 'Chikungunya Fever', 'Chikungunya Virus Infection']", - "diseases_list": [ - "Viral Vaccines", - "Chikungunya Fever", - "Chikungunya Virus Infection" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n A participant must meet all of the following criteria: \n\n 18 to 50 years old \n\n Available for clinical follow-up through Week 44 \n\n Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process \n\n Complete an Assessment of Understanding prior to enrollment and verbalize understanding of all questions answered incorrectly \n\n Able and willing to complete the informed consent process \n\n Willing to donate blood for sample storage to be used for future research \n\n In good general health, with a BMI less than or equal to 40, without clinically significant medical history, and has satisfactorily completed screening \n\n Physical examination and laboratory results without clinically significant findings within the 56 days prior to enrollment \n\n Laboratory Criteria within 56 days prior to enrollment: \n\n Hemoglobin greater than or equal to11.5 g/dL for women; greater than or equal to13.5 g/dL for men \n\n WBC: 3,000-12,000 cells/mm(3). \n\n Differential either within institutional normal range or accompanied by physician approval \n\n Total lymphocyte count: greater than or equal to 800 cells/mm(3) \n\n Platelets = 125,000-500,000/mm(3) \n\n Alanine aminotransferase (ALT) less than or equal to 1.25 times upper limit of normal range \n\n Serum creatinine less than or equal to1x upper limit of normal (less than or equal to1.3 mg/dL for females; less than or equal to1.4 mg/dL for males). \n\n Negative FDA-approved HIV blood test \n\n Female-Specific Criteria \n\n Negative Beta-HCG pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential \n\n A woman of childbearing potential must agree to use an effective means of birth control from at least 21 days prior to enrollment through 12 weeks after last study vaccination \n\n ", - "exclusion_criteria": ": \n\n A participant will be excluded if one or more of the following conditions apply: \n\n Female-Specific Criteria \n\n Woman who is breast-feeding or planning to become pregnant during the time projected for individual study participation \n\n Systemic immunosuppressive medications or cytotoxic medications within 12 weeks prior to enrollment [with the exceptions that a short course of corticosteroids (less than or equal to10 days duration or a single injection) for a self-limited condition at least 2 weeks prior to enrollment will not exclude study participation] \n\n Blood products within 16 weeks prior to enrollment \n\n Immunoglobulin within 8 weeks prior to enrollment \n\n Prior vaccinations with an investigational CHIKV vaccine \n\n Investigational research agents within 4 weeks prior to enrollment \n\n Live attenuated vaccines within 4 weeks prior to enrollment \n\n Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 2 weeks prior to enrollment \n\n Current anti-TB prophylaxis or therapy \n\n Subject has a history of any of the following clinically significant conditions: \n\n A history of confirmed or suspected CHIKV infection \n\n A history of immune-mediated or clinically significant arthritis \n\n Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator \n\n Hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema \n\n Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that is expected to require the use of oral or intravenous corticosteroids \n\n Diabetes mellitus (type I or II), with the exception of gestational diabetes \n\n Idiopathic urticaria within the past year \n\n Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws \n\n Malignancy that is active, or treated malignancy for which there is not reasonable assurance of sustained cure, or malignancy that is likely to recur during the period of the study \n\n Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years \n\n Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen \n\n Psychiatric condition that may preclude compliance with the protocol; past or present psychoses; disorder requiring lithium; or within five years prior to enrollment, a history of suicide plan or attempt \n\n Any medical condition (such as thyroid disease or hypertension that are not well controlled by medication, or viral hepatitis) that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent", - "brief_summary": "Background:~- Chikungunya virus (CHIKV) is transmitted by mosquitoes. It can cause fever, headache, muscle pain, fatigue, and joint pain. The disease usually does not cause death. But the joint pain, which may be directly related to the infecting virus, may be severe and last for several months. CHIKV outbreaks are most common in Africa, India, and Asia. A new experimental vaccine for CHIKV has been developed, and researchers are testing it in healthy adults. Participants cannot develop CHIKV from this vaccine.~Objectives:~- To test the safety and effectiveness of a Chikungunya virus vaccine.~Eligibility:~- Healthy individuals between 18 and 50 years of age.~Design:~This study, including vaccine doses and followup tests, will last about 44 weeks. Participants will have three vaccination visits, six followup clinic visits, and three telephone contacts during this study. Vaccination visits will take about 4 hours. Most other clinic visits will usually take 2 hours. The telephone contacts will take about 15 minutes.~Participants will be screened with a physical exam and medical history. Blood samples will also be collected.~Participants will be assigned to one of three dose groups. Information about doses will be provided before the start of the vaccinations.~Vaccine injections will be given at the start of the study, at 4 weeks, and at 20 weeks. Participants will be asked to keep an eye on the injection site for 7 days and to notify researchers if there are any side effects.~Participants will be monitored throughout the study with blood samples and clinic visits.", - "NCTID": "NCT01489358" - }, - { - "brief_title": "Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine", - "phase": "Phase 1", - "drugs": "['D1ME100 (dengue-1 premembrane/envelope DNA vaccine)']", - "drugs_list": [ - "D1ME100 (dengue-1 premembrane/envelope DNA vaccine)" - ], - "diseases": "['Dengue']", - "diseases_list": [ - "Dengue" - ], - "enrollment": "22.0", - "inclusion_criteria": "inclusion criteria: \n\n Available to participate for the duration of the study (approximately 12 months) \n\n Completion and review of knowledge assement quiz \n\n ", - "exclusion_criteria": ": \n\n Pregnant (by history or as ascertained by pregnancy test) or lactating female \n\n Female who intends to become pregnant during the study \n\n Plan to have elective surgery during the study period \n\n HIV infection \n\n Known immunodeficiency or currently receiving immunosuppressive therapy (inhaled and topical steroids are allowed) \n\n History of splenectomy \n\n Administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 30 days after vaccination \n\n Evidence of active (acute or chronic) hepatitis B or C infection \n\n Autoimmune diseaseor subjects who describe a first-degree relative with clearly documented autoimmune disease \n\n Acute or chronic, clinically significant cardiac, pulmonary, hepatic, or renal abnormality, as determined by physical examination or basic laboratory screening \n\n Clinical or laboratory evidence of significant anemia \n\n History of flavivirus infection or previous receipt of flavivirus vaccine \n\n Positive serology for flaviviruses (all four dengue virus serotypes, Japanese encephalitis, Yellow fever virus, and West Nile virus), HIV-1, Hepatitis B surface antigen, or anti-hepatitis C virus antibodies prior to enrollment \n\n Use of any investigational or non-registered drug or vaccine other than the study vaccine within 60 days preceding the first dose of study vaccine, or planned use during the study period. \n\n Previous history of allergic or anaphylactic reaction to any vaccine \n\n Planned travel to areas with endemic dengue during the study period \n\n Any other significant finding which, in the opinion of the investigator, would increase the risk of having an adverse outcome from participating in this protocol", - "brief_summary": "The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.", - "NCTID": "NCT00290147" - }, - { - "brief_title": "Yellow Fever Virus Vaccine and Immune Globulin Study", - "phase": "Phase 1", - "drugs": "['YF-VAX\u00ae plus saline', '17D YF Vaccine plus Ig,']", - "drugs_list": [ - "YF-VAX\u00ae plus saline", - "17D YF Vaccine plus Ig," - ], - "diseases": "['Viremia']", - "diseases_list": [ - "Viremia" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n Able to understand and give informed consent \n\n Age 18-40 years old \n\n No medical contraindications to participation discovered at the screening visit \n\n Negative serologic test for HIV, HCV and Hepatitis B surface antigen at the screening visit \n\n Female volunteers of childbearing potential must agree to use effective birth control throughout the duration of the study. A negative urine pregnancy test must be documented prior to any injection. \n\n Must weigh at least 110 lbs \n\n ", - "exclusion_criteria": ": \n\n Any history of allergy or history of anaphylaxis to any of the vaccine components \n\n Any history of allergic reaction to human immune globulin or a history of IgA deficiency \n\n History of hypersensitivity to ingestion of eggs or allergic reaction to vaccines prepared in eggs or chick embryo cell cultures (e.g. influenza, measles) \n\n Known or suspected immunodeficiency (e.g. HIV infection, primary immunodeficiency disorder, leukemia, lymphoma), use of immunosuppressive or antineoplastic drugs (corticosteroids> 10 mg prednisolone/prednisone, or equivalent, for mare than 14 days in the last three months). Persons with previous skin cancer or cured non-lymphatic tumors are not excluded from the study. \n\n Any clinically significant chronic medical condition that is considered progressive including: hypertension, diabetes, gastrointestinal abnormalities (e.g. active peptic ulcer disease), cardiac, pulmonary, hepatic, renal, or neurologic disease. \n\n History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions, or occupational requirements that in the opinion of the investigator would preclude compliance with the trial \n\n Receipt of any live or inactivated vaccine between the screening visit and the day 0 visit, or any vaccine within 30 days of a vaccination visit \n\n Any subject found to be HIV positive, hepatitis B surface antigen positive, or hepatitis C antibody positive at the time of screening \n\n Any contraindication to intramuscular injection \n\n Women who are pregnant, nursing or expect to become pregnant during the study period \n\n Administration of a blood product or immune globulin product within 6 months of injection \n\n History of previous yellow fever, West Nile, dengue, St. Louis encephalitis, Japanese encephalitis or tick-borne encephalitis vaccination or infection \n\n Serologic evidence of previous yellow fever, West Nile, dengue, St. Louis encephalitis, Japanese encephalitis or tick-borne encephalitis vaccination or infection \n\n History of travel to a yellow fever endemic zone as defined by the Centers for Disease Control and Prevention. Health Information for International Travel, 2005-2006 \n\n History of thymus disorder or dysfunction, including myasthenia gravis, thymoma, thymectomy, or DiGeorge syndrome \n\n History of an autoimmune disorder", - "brief_summary": "The purpose of this study is to determine whether immune globulin can limit the amount of yellow fever vaccine virus present in the blood after vaccination without compromising the immunity associated with the yellow fever vaccine. The study will enroll 80 participants in two groups of 40 each. The first group will receive the yellow fever vaccine with salt-water placebo. The second group will receive yellow fever vaccine with immune globulin. The amount of vaccine virus and immune response in both groups will be compared. Yellow fever vaccine has been used to protect humans against Yellow Fever Vaccine disease since the 1930s.", - "NCTID": "NCT00254826" - }, - { - "brief_title": "Treatment of Viral Hemorrhagic Fevers With Intravenous Ribavirin in Military Treatment Facilities", - "phase": "Phase 2", - "drugs": "['Ribavirin (Virazole) Injection']", - "drugs_list": [ - "Ribavirin (Virazole) Injection" - ], - "diseases": "['Lassa Fever', 'Crimean-Congo Hemorrhagic Fever']", - "diseases_list": [ - "Lassa Fever", - "Crimean-Congo Hemorrhagic Fever" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n An individual will be enrolled in this study if the patient: \n\n Meets the case definition for a probable or a suspected case of CCHF or LF (see below). \n\n Has read and signed the Informed Consent. \n\n Is at least 18 years of age (17, if active military) and not greater than 65 years of age. \n\n Has a blood sample drawn and a type and cross-match ordered for transfusion. \n\n Agrees to collection of required specimens. \n\n Agrees to report any Adverse Events, Serious and Unexpected Adverse Events for the duration of the study. \n\n Agrees to a follow-up visit and to donate blood and urine specimens at day 14 (\u00b12 days) and once between days 28 and 60 after the first dose of IV Ribavirin and to all follow-up visits for anemia or other medical conditions as required by the attending physician. \n\n Woman of childbearing age must have a pregnancy test performed. If negative, she must agree not to become pregnant during treatment and for 7 months after receiving Ribavirin. She also must agree to not breast feed during treatment and for 7 months after receiving Ribavirin. Two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period. She will be counseled concerning the risks of IV Ribavirin versus no treatment if the pregnancy test is positive. \n\n Man agrees not to have intercourse with pregnant woman during treatment and for 7 months after receiving Ribavirin, and take precautions to avoid producing pregnancies during treatment and for 7 months after receiving Ribavirin. At least two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period to avoid a pregnancy. \n\n Has a hemoglobin greater than or equal to10 g/dL before starting IV Ribavirin \n\n Note: Malaria should be excluded as a possibility for illness in patients suspected to have VHF. \n\n Probable Case of Crimean-Congo Hemorrhagic Fever: \n\n All subjects will have a history of possible exposure to CCHF, either having: \n\n Worked or slept outdoors in the CCHF endemic area within 2 weeks of illness onset, with or without a history of tick-bite or tick exposure, (Endemic area includes, but not necessarily limited to: Saudi Arabia, Kuwait, Oman, United Arab Emirates, Iran, Iraq, Turkey, Greece, Bulgaria, Albania, Montenegro, the Kosovo region of Serbia, Bosnia-Herzegovina, Macedonia, the whole of Africa, India, Pakistan, Afghanistan, Kazakhstan, Uzbekistan, Kyrgyzstan, Tajikistan, Turkmenistan, Azerbaijan, Georgia, the Crimean region of the Ukraine, Rostov-Don and Astrakhan regions of Russia, and the Xinjiang [northwestern] region of the People's Republic of China), OR \n\n Handled blood or freshly butchered meat of domestic livestock in CCHF endemic area during 2 weeks before the onset of illness, OR \n\n Had direct contact with blood, tissues, secretions, or excretions of a CCHF patient (suspected or confirmed), including laboratory specimens, OR \n\n Worked with the virus in the laboratory setting and have a clinical syndrome consistent with CCHF as defined by: \n\n Acute illness with fever and at least two of these symptoms: myalgia, low back pain, and headache, \n\n And the appearance of three or more of the following five groups of signs/symptoms: \n\n Hemorrhage (one or more petechiae, ecchymoses, purpura, gingival bleeding, epistaxis, gastrointestinal tract bleeding), \n\n Elevated AST levels (above the upper limits of normal for the laboratory), \n\n Thrombocytopenia (below the lower limits of normal), \n\n Hypotension (systolic pressure < 90 mm Hg), or \n\n Azotemia, renal failure (serum creatinine above the upper limits of normal). \n\n Prognostic indicators exist for subjects at increased risk of severe CCHF. Any of these indicators occurring in the first 5 days of illness, predict a mortality greater than 90% (Swanepoel et al., 1989). Patients with these prognostic indicators may benefit most from drug therapy, if resources become limiting: \n\n WBC > 10,000/mm3 \n\n Platelet count < 20 x 103/mm3 \n\n AST > 200 U/L \n\n ALT > 150 U/L \n\n APTT > 60 seconds \n\n Fibrinogen < 110 mg/dL \n\n Probable Case of Lassa Fever: \n\n All subjects will have a history of possible exposure to Lassa fever, either having: \n\n By residence or travel in an endemic area where contact with rodents was possible within 3 weeks of onset of illness, (Endemic area includes, but not necessarily limited to: Sierra Leone, Liberia, Nigeria, Mali, Central African Republic, and Guinea.) or \n\n Contact with a suspect patient or their body fluids (including laboratory specimens) within 3 weeks of symptom onset, or \n\n Worked with the virus in the laboratory setting. And have \n\n A negative malaria smear. And have \n\n Signs and symptoms compatible with Lassa fever, either: \n\n Fever plus pharyngitis plus retrosternal pain plus proteinuria (positive predictive value of 81% when these three criteria are met, McCormick et al., 1987a,b),OR \n\n Fever plus unexplained mucosal bleeding, OR \n\n Fever plus unexplained edema of the face and neck, OR \n\n Suspected Case of CCHF or LF \n\n Have a clinical syndrome consistent with CCHF or LF, meeting most of the above criteria of a probable case and the patient has an epidemiological history of potential exposure to the bunyavirus or arenavirus (i.e., recent field duty and/or other individuals in his troop have CCHF or LF). \n\n ", - "exclusion_criteria": ": \n\n Has known intolerance to Ribavirin. \n\n Is irreversibly ill on presentation, as defined by presence of profound shock (shock which does not respond to supportive therapy within 3 hours after admission). \n\n Has hemoglobin less than 10 g/dL that cannot be corrected to 10 g/dL before initiation of IV Ribavirin \n\n Has history of hemoglobinopathies (i.e., sickle-cell anemia or thalassemia major). \n\n Has history of autoimmune hepatitis. \n\n Has a calculated serum creatinine clearance of < 30 mL/min. \n\n History of such as second or third degree heart block or sick sinus syndrome and without a pacemaker and no capability of a pacemaker placement or Wolfe-Parkinson-White Syndrome. \n\n A sinus bradycardia of less than 40 beats per minute. \n\n Is currently being treated with Didanosine (ddI). ddI must be discontinued before starting IV Ribavirin. \n\n Relative ", - "brief_summary": "This is a Phase 2 study of the safety and efficacy of Intravenous (IV) Ribavirin in treating patients presenting with a probable or suspected case of viral hemorrhagic fever (either Crimean Congo or Lassa Fever) at a military medical treatment hospital. All patients will be treated with a 10 day course of IV Ribavirin if they meet all the inclusion and none of the exclusion criteria.", - "NCTID": "NCT00992693" - }, - { - "brief_title": "Study of Live Attenuated ChimeriVax\u2122-Japanese Encephalitis Vaccine", - "phase": "Phase 2", - "drugs": "['Live attenuated Japanese encephalitis virus', 'Live attenuated Japanese encephalitis virus', 'Live attenuated Japanese encephalitis virus', 'ChimeriVax\u2122 diluent (Placebo)']", - "drugs_list": [ - "Live attenuated Japanese encephalitis virus", - "Live attenuated Japanese encephalitis virus", - "Live attenuated Japanese encephalitis virus", - "ChimeriVax\u2122 diluent (Placebo)" - ], - "diseases": "['Japanese Encephalitis']", - "diseases_list": [ - "Japanese Encephalitis" - ], - "enrollment": "128.0", - "inclusion_criteria": "inclusion criteria : \n\n All aspects of the protocol explained and written informed consent obtained from the participant. \n\n Aged \u226518 to < 49 years. \n\n In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results. \n\n Participant must be available for the study duration, including all planned follow-up visits. \n\n Participant must agree to take the following precautions to avoid insect bites for 7 days following vaccination by using N,N-diethyl-meta-toluamide (DEET)-containing insect repellent, where appropriate. \n\n For female participants: Negative pregnancy tests at Screening and Day 0, in conjunction with a menstrual and contraceptive history indicating a low probability of pregnancy in the opinion of the physician. Females of childbearing potential will be required to be correctly using an efficacious hormonal method of contraception or intrauterine device for at least 1 month before randomisation and during the on-study phase to Day 30. Barrier methods of contraception will not be considered acceptable for study entry. Female participants of child-bearing potential will sign an agreement that contraception will be correctly practised during the specified periods and will specify the method used. Female participants unable to become pregnant must have this documented (e.g., tubal ligation, hysterectomy or postmenopausal [at least one year since last menstrual period]). \n\n ", - "exclusion_criteria": " : \n\n A history of vaccination or infection to Japanese encephalitis (JE) or yellow fever (YF) or other flaviviruses (including Japanese encephalitis, tick-borne encephalitis, St Louis encephalitis, West Nile virus, dengue fever, Murray Valley encephalitis). Previous vaccination will be determined by history (interview of subject). \n\n Previous or current military service. \n\n History of residence in or travel to flavivirus endemic areas in the tropics (Cape York region of Northern Queensland, India, Southeast Asia, Central America, Caribbean or South America) for periods of 4 weeks or more. \n\n Known or suspected immunodeficiency (e.g., human immunodeficiency virus [HIV] infection, primary immunodeficiency disorder, leukemia, lymphoma), use of immunosuppressive or antineoplastic drugs (corticosteroids > 10 mg prednisone, or equivalent, in the last three months or during the trial (up to Day 30). \n\n History of thymoma, thymic surgery (removal) or myasthenia gravis. \n\n Clinically significant abnormalities on laboratory assessment (i.e., meeting the mild, moderate or severe criteria described in the toxicity gradings for laboratory values). \n\n Anaphylaxis or other serious adverse reactions characterised by urticaria or angioedema to foods, hymenoptera (bee family) stings, or drugs (including vaccines). \n\n Transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit or up to Day 30. \n\n Administration of another vaccine or antiviral within 30 days preceding the screening visit or up to Day 30 (these subjects will be rescheduled for vaccination at a later date). \n\n Physical examination indicating any clinically significant medical condition. \n\n Body temperature > 38.1\u00b0C (100.6\u00b0F) or acute illness within 3 days prior to inoculation (participant may be rescheduled). \n\n Intention to travel out of the area prior to the study visit on Day 30. \n\n Seropositive to hepatitis C virus or HIV or positive for Hepatitis B Surface Antigen. \n\n Lactation or intended pregnancy in female subjects. \n\n Excessive alcohol consumption, drug abuse, significant psychiatric illness. \n\n A known or suspected physiological or structural condition that compromises the integrity of the blood-brain barrier (e.g., significant hypertensive cerebrovascular disease, trauma, ischaemia, infection, inflammation of the brain). \n\n Intention to increase normal exercise routine, participate in contact sports or strenuous weight lifting or to initiate vigorous exercise from Screening until after Day 30.", - "brief_summary": "The purpose of this study is to assess the safety, tolerability, and immunogenicity of a new formulation of lyophilised ChimeriVax\u2122-JE, given at three dose levels, compared with placebo.~Primary Objectives:~Safety:~To obtain safety and tolerability data for a single subcutaneous vaccination with ChimeriVax\u2122-JE, at three dose levels, in healthy adult volunteers (18-49 years old).~Immunogenicity:~To obtain data on the antibody response to a single subcutaneous vaccination with ChimeriVax\u2122-JE, at three dose levels, in healthy adult volunteers without prior Japanese encephalitis immunity.~To assess the durability of immune response up to 12 months following a single subcutaneous vaccination with ChimeriVax\u2122-JE, at three dose levels.", - "NCTID": "NCT00981630" - }, - { - "brief_title": "Safety and Efficacy Study of Intravenous Immunoglobulin to Treat Japanese Encephalitis", - "phase": "Phase 2", - "drugs": "['Intravenous immunoglobulin [ImmunoRel\u2122 (batch 20081217)]']", - "drugs_list": [ - "Intravenous immunoglobulin [ImmunoRel\u2122 (batch 20081217)]" - ], - "diseases": "['Japanese Encephalitis']", - "diseases_list": [ - "Japanese Encephalitis" - ], - "enrollment": "22.0", - "inclusion_criteria": "inclusion criteria: \n\n Children aged between 1 and 14 years who had clinically diagnosed encephalitis on the basis of history of fever that lasted less than 14 days, altered consciousness with or without a history of new onset seizures with CSF finding of white cell count less than 1000 cells/mm3 with no organisms on Gram stain and a CSF: plasma glucose ratio > 40% admitted in Kanti Children's Hospital and BP Koirala Institute of Health Sciences, Nepal. \n\n ", - "exclusion_criteria": ": \n\n Asexual Plasmodium falciparum parasites in blood \n\n Coma appears secondary to other systemic condition, eg hepatic failure, cardiac failure, toxins. \n\n Patients who have documented antibiotic treatment before admission and in whom partially treated bacterial meningitis appears more likely than encephalitis \n\n Children with simple febrile convulsions, defined as a single seizure lasting less than 15 minutes followed by full recovery of consciousness within 60 minutes. \n\n Pregnant or breastfeeding females \n\n Children with a GCS of 3/15, who were receiving artificial ventilation without signs of spontaneous respiration, and with absent oculocephalic reflex.", - "brief_summary": "Japanese encephalitis is caused by a viral infection of the brain transmitted by the bite of an infected mosquito. Patients with Japanese encephalitis can rapidly develop worsening conscious level and seizures. Around a third will die from the infection and half of survivors have serious long-term neurological disability. The majority of those affected are children. There are many causes of viral encephalitis, however Japanese encephalitis virus is the most common cause worldwide with over 60,000 cases annually. It occurs over much of Asia and the geographical range is expanding. There is no specific treatment for Japanese encephalitis virus, although several have been trialed. In this study we examined the effect of a new treatment, called intravenous immunoglobulin, on children with Japanese encephalitis in Nepal. Prior studies have suggested intravenous immunoglobulin may neutralize Japanese encephalitis virus and suppress damaging inflammation in the brain. It has previously been used in individual cases but never examined in a randomized trial. There was recently a trial of IVIG in West Nile encephalitis in the United States, in which Professor Solomon was on the Scientific Advisory Committee. In this study we will look if intravenous immunoglobulin is safe in this context, and that this treatment may alter the way the immune system manages the infection. Therefore, in this pilot study we will test the hypothesis that IVIG can be safely given to children with suspected JE, with no increased risk of serious adverse events compared with placebo. The aim of this proposal is to conduct a pilot safety and tolerability randomized placebo controlled trial of intravenous immunoglobulin (IVIG) in patients with Japanese encephalitis, to explore the relationship between JEV viral load, pro-inflammatory markers called cytokines and blood brain barrier markers, and the effect of IVIG on these relationships.", - "NCTID": "NCT01856205" - }, - { - "brief_title": "Study of the Prognostic Value of Musculoskeletal Ultrasound in Adults With Chikungunya", - "phase": "", - "drugs": "['SF36 (QQoL)']", - "drugs_list": [ - "SF36 (QQoL)" - ], - "diseases": "['Infected by Chikungunya Virus']", - "diseases_list": [ - "Infected by Chikungunya Virus" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Age at onset of symptoms \u2265 45 years \n\n Seen in consultation at the University Hospital of Fort-de-France \n\n Suspected chikungunya infection (fever and sudden onset of joint pain affecting the wrists, hands, ankles or knees) \n\n Duration of symptoms suggestive of infection chikungunya less than or equal to 10 days \n\n Presence of joint pain on the day of inclusion \n\n No history of inflammatory arthritis \n\n Absence of steroidal or non-steroidal anti-inflammatory drugs taken within two weeks prior to inclusion \n\n Ability to participate in the study throughout its duration (12 months) \n\n Patient affiliated or beneficiary of a social health care. \n\n Acceptance to participate in the study and monitoring proposed and signed informed consent \n\n ", - "exclusion_criteria": ": \n\n Age at onset of symptoms <45 years \n\n Duration of symptoms suggestive of chikungunya for more than 10 days \n\n Lack of joint pain on the day of inclusion \n\n History of inflammatory arthritis Nonsteroidal anti-inflammatory drugs or \n\n Taking in the two weeks preceding the inclusion \n\n Inability to participate in the study throughout its duration (12 months) \n\n Patient is not affiliated or beneficiary of a social health care. \n\n Refusal to participate in the study or to sign a consent", - "brief_summary": "Chikungunya is a viral disease transmitted by mosquitoes whose clinical feature is the early joint damage. Approximately 8% of patients have chronic arthropathy resembling to the rheumatoid polyarthritis. The EchoCHIK study we propose is in the context of the epidemic in Martinique which began in January 2014. It should give a better understanding of arthritis and juxtaarticular of CHIK and look for signs that may allow ultrasound predict the evolution of chronic arthropathy of CHIK.", - "NCTID": "NCT02281123" - }, - { - "brief_title": "Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects", - "phase": "Phase 2", - "drugs": "['Ty800 (Salmonella typhi) Oral Vaccine']", - "drugs_list": [ - "Ty800 (Salmonella typhi) Oral Vaccine" - ], - "diseases": "['Typhoid Fever']", - "diseases_list": [ - "Typhoid Fever" - ], - "enrollment": "180.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy Males or Females aged 18 to 55 years, inclusive \n\n Capable of understanding and complying with the protocol requirements and be available for the duration of the protocol \n\n ", - "exclusion_criteria": ": \n\n History of malignancy, immunocompromised conditions or currently receiving immunosuppressive treatment including systemic steroids \n\n History of Typhoid Fever infection, vaccination against typhoid fever or participation in a Clinical Trial using S.typhi organism at any time \n\n History of travel to a typhoid endemic region within the last 5 years or history of raising a child from an endemic area. Endemic regions are South and East Asia, the Indian Subcontinent, Africa and Central and South America including Mexico \n\n History of persistent diarrhea, blood in stool, peptic ulcer disease, or inflammatory bowel disease \n\n Allergies or sensitivities to antibiotics, notably quinolones, penicillins, sulfonamides, cefalosporins and chloramphenicol, and components of the buffer solution, notably aspartame. \n\n People who are commercial food handlers, day care workers, or health care workers involved in direct patient care. Also people with young children under 2 years of age at home or household contacts who are immunocompromised, pregnant or breast-feeding", - "brief_summary": "The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine in healthy adult subjects.", - "NCTID": "NCT00498654" - }, - { - "brief_title": "Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants", - "phase": "Phase 2", - "drugs": "['Vi-CRM197 vaccine', 'Vi Polysaccharide (PS) vaccine', 'Pneumococcal conjugate vaccine']", - "drugs_list": [ - "Vi-CRM197 vaccine", - "Vi Polysaccharide (PS) vaccine", - "Pneumococcal conjugate vaccine" - ], - "diseases": "['Typhoid Fever']", - "diseases_list": [ - "Typhoid Fever" - ], - "enrollment": "200.0", - "inclusion_criteria": "Main eligibility criteria: \n\n Subjects belonging to 4 age groups will be enrolled into the trial: adults (18 to 45 years of age), children (24 to 59 months of age), older infants (9 to 12 months of age at enrollment) and infants (6 weeks of age at enrolment). \n\n Written informed consent will be obtained by the all subjects or their parents/ guardians (depending on the age group) before enrollment into the trial. \n\n Only females with a negative pregnancy test and willing to participate in family planning consultations (organized by the site study team) will be allowed to participate to the trial. \n\n Infants who have been vaccinated with 1 dose of BCG, HBV and OPV at birth can be enrolled into the trial, while infants who have received DTwP+HBV+Hib or OPV due at 6 weeks of age as per local EPI schedule cannot be enrolled into the trial.", - "exclusion_criteria": "", - "brief_summary": "This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in subjects from various age groups in India and Pakistan where Typhoid Fever is highly endemic and an efficacious vaccine against this disease is very much needed.", - "NCTID": "NCT01229176" - }, - { - "brief_title": "Topical PluroGel N for the Treatment of Mildly Infected Diabetic Foot Ulcers", - "phase": "Phase 2", - "drugs": "['PluroGel N', 'PluroGel']", - "drugs_list": [ - "PluroGel N", - "PluroGel" - ], - "diseases": "['Diabetic Foot Ulcer', 'Infection']", - "diseases_list": [ - "Diabetic Foot Ulcer", - "Infection" - ], - "enrollment": "42.0", - "inclusion_criteria": "inclusion criteria: \n\n Non-hospitalized subjects with Type 1 or Type 2 diabetes mellitus as defined by the American Diabetes Association diagnostic criteria (ADA, 2010). Diabetes may be treated with insulin, oral hypoglycemic agents, diet, or a combination of these therapies. Subjects whose diabetes is considered controlled by diet or medication in the opinion of the physician. \n\n Males or females at least 18 years old. \n\n Subjects must be considered by the investigator to be reliable, willing and able to give signed informed consent, and must sign the informed consent form. \n\n Subjects must have a full thickness (i.e., extending through dermis but not involving tendon, bone, or joint capsule) ulcer on the foot distal to the malleoli with a surface area \u22651 cm2 after the wound has undergone appropriate debridement. Subjects must have localized mild infection of the ulcer, as defined by the IDSA criteria as per Appendix C, with in the PGN1300 Protocol, which the investigator believes would ordinarily be treated on an outpatient basis. \n\n IDSA mild infection of an ulcer is defined as: \n\n The presence of \u22652 of the following items: \n\n Local swelling or induration \n\n Erythema \n\n Local tenderness or pain \n\n Local warmth \n\n Purulent discharge (thick, opaque to white or sanguineous secretion) Local infection involving only the skin and the subcutaneous tissue. If erythema, must be >0.5 cm to \u22642 cm around the ulcer. \n\n Diabetic Foot Infection-General Parameters Score of at least 2 must be obtained in order to be eligible for enrollment. \n\n Diabetic Foot Infection-Wound Size Score of at least 1 must be obtained in order to be eligible for enrollment. \n\n The diagnosis of mild infection must be confirmed immediately following the Day 0 (Enrollment Visit) debridement, although pre-debridement purulence is to be counted as one manifestation of infection. \n\n ", - "exclusion_criteria": ": \n\n Subjects with IDSA-defined moderate infection as per Appendix C, including cellulitis extending > 2 cm; lymphangitis; spread beneath the fascia; deep tissue abscess; osteomyelitis; gangrene; muscle, joint, or bone involvement. \n\n Subjects with IDSA-defined severe infection as per Appendix C, within PGN1300 Protocol including systemic toxicity or metabolic instability (e.g., fever, chills, tachycardia, hypotension, confusion, vomiting, leukocytosis, acidosis, hyperglycemia, or azotemia). \n\n Subjects with systemic inflammatory response signs, as manifested by \u22652 of the following : \n\n Temperature >38\u00b0C or <36\u00b0C \n\n Heart rate >90 beats/min \n\n Respiratory rate >20 breaths/min or PaCO2 <32 mm Hg \n\n White blood cell count >12 000 or <4000 cells/\u03bcL or \u226510% immature (band) forms \n\n Subjects with local wound complications (e.g., prosthetic materials). \n\n Subjects currently receiving antibiotic treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment. \n\n Subjects requiring concurrent systemic antimicrobials during the study period for any infection, including diabetic foot ulcer. \n\n Subjects in whom bone or joint involvement is suspected based on clinical examination (e.g., bone noted visually or by probing) or plain view X-ray. \n\n Subjects with clinically significant peripheral arterial disease requiring vascular reconstructive surgery. Subjects who are expected to be unable to care for their ulcer because of hospitalization, vacation, disability, etc. during the study period, or are unable to safely monitor the infection status at home. \n\n Subjects with known active alcohol or substance abuse within the 6 months preceding study entry. \n\n Subjects who are receiving immunosuppressive agents (other than corticosteroids), radiation therapy, or cytotoxic agents. \n\n Subjects who require treatment for a primary or metastatic malignancy (other than squamous or basal cell carcinoma of the skin). \n\n Subjects with a systemically immunocompromising disease, such as acquired immune deficiency syndrome or known human immunodeficiency virus infection. \n\n Subjects who have had an unexplained fever or chills during the week prior to enrollment. \n\n Subjects with other conditions considered by the investigator to be reasons for disqualification that may jeopardize subject safety or interfere with the objectives of the trial (e.g., acute illness or exacerbation of chronic illness, lack of motivation, history of poor compliance). \n\n Subjects with any known allergy or other contraindication to any ingredients in the study products. \n\n Women who are breast feeding, pregnant, or not using contraception unless sterile. \n\n Subjects who have been taking or expect to be taking any other investigational therapy within the 30 days prior to entry or during enrollment.", - "brief_summary": "This will be a randomized, double-blind (evaluator-blind), vehicle-controlled study of 50 enrolled subjects. Adult subjects (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the dermis but not involving joint capsule, tendon, and bone). Subjects must also provide informed consent and meet all other entry criteria to be enrolled and randomly assigned to receive PluroGel N or PluroGel vehicle.", - "NCTID": "NCT02091596" - }, - { - "brief_title": "Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS", - "phase": "Phase 3", - "drugs": "['13-valent pneumococcal conjugate vaccine', 'Blood draw']", - "drugs_list": [ - "13-valent pneumococcal conjugate vaccine", - "Blood draw" - ], - "diseases": "['HIV Infections', 'Pneumococcal Infections']", - "diseases_list": [ - "HIV Infections", - "Pneumococcal Infections" - ], - "enrollment": "331.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female subjects aged 18 years or older at the time of enrollment. \n\n All female and male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control from the signing of the informed consent form (ICF) until 3 months after the last dose of investigational product. \n\n Documented vaccination with 1 or more doses of 23vPS at least 6 months before study enrollment. \n\n CD4+ T-cell count >= 200 cells/\u00b5, obtained on the most recent 2 occasions within 6 months before the first investigational product vaccination. \n\n HIV-infected subjects with viral load <50,000 copies/mL, obtained on the most recent 2 occasions within 6 months before the first investigational product vaccination. \n\n Subject is receiving a stable dose of HAART for at least 6 weeks prior to the first investigational product vaccination, or not currently receiving antiretroviral therapy. \n\n Subject is expected to be available for the entire study period (approximately 18 months) and can be contacted by telephone. \n\n Subject must be able to complete an electronic diary (e-diary) and complete all relevant study procedures during study participation. \n\n Subject is deemed to be eligible for the study on the basis of medical history, physical examination, and clinical judgment. (Note: Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 6 weeks before investigational product vaccination, are eligible.) \n\n ", - "exclusion_criteria": ": \n\n Subjects with active AIDS related illness, including opportunistic infections or malignancy. \n\n Evidence of current illicit substance and/or alcohol abuse, that in the investigator's opinion, precludes the subject from participating in the study or interferes with the evaluation of the study objectives.. \n\n Receipt of any licensed or experimental pneumococcal conjugate vaccine prior to enrollment. \n\n Contraindication to vaccination with pneumococcal conjugate vaccine. \n\n Previous anaphylactic reaction to any vaccine or vaccine-related component. \n\n History of culture-proven invasive disease caused by Streptococcus pneumoniae within the last year. \n\n Current anticoagulant therapy or a history of bleeding diathesis or any condition associated with prolonged bleeding time that would contraindicate intramuscular injection. (Note: Use of antiplatelet drugs, such as aspirin and clopidogrel, is permitted.) \n\n Pregnant or breastfeeding women, as defined by history or positive human chorionic gonadotropin (hCG) urine test. All women of childbearing potential must have a urine pregnancy test. \n\n History of active hepatitis with elevation in pretreatment aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values >5 times the upper limit of normal within the last 6 months. \n\n Serious chronic disorder or any other disorder that, in the investigator's opinion, precludes the subject from participating in the study or interferes with the evaluation of the study objectives. (Note: Serious chronic disorders include metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, and clinically unstable cardiac disease). \n\n Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of, the study, or could preclude the evaluation of the subject's response. \n\n History of splenectomy. \n\n Receipt of any blood products, including immunoglobulin, within 42 days before investigational product vaccination until the last blood draw for the study (approximately 13 months after the first investigational product vaccination). \n\n Evidence of dementia or other severe cognitive impairment. \n\n Subject who is, in the opinion of the investigator, unable to receive a vaccination in the deltoid muscle of either arm because of insufficient muscle mass. \n\n Participation in another study using investigational product from 28 days before study enrollment until the blood draw at visit 6. Between the blood draw at visit 6 and the 6 month follow-up telephone call (visit 7), use of investigational product must be discussed with the Medical Monitor. (Note: Participation in purely observational studies is acceptable.) \n\n Residence in a nursing home, long-term care facility, or other institution or requirement of semi-skilled nursing care. An ambulatory resident of a retirement home or village is eligible for the trial. \n\n Subject who is a direct relative (child, grandchild, parent, or grandparent) of study personnel, or who is study personnel. \n\n Temporary Delay Criteria: \n\n Current febrile illness (oral temperature of =38.0\u00b0C [100.4\u00b0F]) or other acute illness within 48 hours before study vaccine administration. \n\n Currently receiving antibiotic therapy, or has completed a course of antibiotic therapy within 10 days before study vaccine administration. \n\n Receipt of novel influenza A (H1N1) vaccine within 14 days before investigational product vaccination (seasonal influenza vaccine can be given at any time at the discretion of the investigator).", - "brief_summary": "The study will evaluate the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 18 years of age or older who have been previously immunized with at least one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). All subjects will receive 3 doses of 13vPnC, with each study vaccine dose given approximately 6 months apart.", - "NCTID": "NCT00963235" - } - ], - "1": [ - { - "brief_title": "Studies on the Pathogen, Vector Control and Clinical Treatment of Dengue Fever in Guangzhou", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Dengue Fever']", - "diseases_list": [ - "Dengue Fever" - ], - "enrollment": "2000.0", - "inclusion_criteria": "inclusion criteria: \n\n Dengue patients confirmed by dengue virus NS1 or RNA \n\n ", - "exclusion_criteria": ": \n\n Pregnant women \n\n Fever diseases caused by other viruses \n\n Combined bacterial infection \n\n Without complications such as diabetes and tumor.", - "brief_summary": "The purpose of this study is to elucidate the local epidemic problem and epidemiological characters of dengue fever in Guangzhou, to establish diagnostic and treatment standard and clinical treatment system of severe cases to reduce the morbidity and mortality of dengue fever.", - "NCTID": "NCT02608047" - }, - { - "brief_title": "Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine For The Treatment Of Uncomplicated, Symptomatic Falciparum Malaria In Southeast Asia", - "phase": "Phase 2; Phase 3", - "drugs": "['Azithromycin/Chloroquine', 'Sulfadoxine-Pyrimethamine/Chloroquine']", - "drugs_list": [ - "Azithromycin/Chloroquine", - "Sulfadoxine-Pyrimethamine/Chloroquine" - ], - "diseases": "['Malaria, Falciparum']", - "diseases_list": [ - "Malaria", - "Falciparum" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n Females and males >=18 years of age with uncomplicated, symptomatic malaria as indicated by the presence of both of the following: a.) Blood smears positive for Plasmodium falciparum asexual parasitemia between 1000 -100,000 parasites/mL b.) Fever or history of fever (>= 38.5 C/101.2 F rectal or tympanic; >= 37.5 C/99.5 F axillary or >= 38 C/100.4 F oral) within the prior 24 hours \n\n Serum glucose >= 60 mg/dL (by fingerstick or peripheral blood collection) \n\n Positive rapid diagnostic test (Binax NOW ICT) for P. falciparum \n\n Women of childbearing potential must have a negative urine gonadotropin prior to entry into the study and must agree to use adequate contraception during the entire study \n\n ", - "exclusion_criteria": ": \n\n Severe or complicated malaria including subjects with any of the following: a.) Impaired consciousness, seizures or abnormal neurologic exam b.) Jaundice c.) Respiratory distress d.) Persistent vomiting e.) Hematuria, as reported by the patient f.) Parasite density > 100,000 parasites/mL g.) Presence of non-falciparum species on microscopy \n\n Pregnant or breast-feeding women \n\n History of allergy to or hypersensitivity to azithromycin or any macrolide, sulfonamides, pyrimethamine, or chloroquine \n\n Known history of blood dyscrasias (e.g., megaloblastic anemia, agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia) \n\n History of epilepsy or psoriasis \n\n History of treatment with any antimalarial drug (chloroquine, quinine, mefloquine, Malarone, SP, artemisinin compounds) or antibacterial with known antimalarial activity (macrolides, doxycycline, clindamycin) within 2 weeks prior to enrollment into the study \n\n Known or suspected cardiovascular, hepatic or renal abnormality that in the opinion of the Investigator would place the subject at increased risk to participate in the study. The following findings are specific exclusions: a.) serum creatinine > 2.0 x ULN b.) ALT and/or AST > 3 x ULN \n\n Inability to swallow oral medication in tablet form \n\n Treatment with other investigational drugs within 30 Days prior to enrollment into the study \n\n Alcohol and/or any other drug abuse \n\n Requirement to use medication during the study that might interfere with the evaluation of the study drug (nelfinavir, digoxin, ergot alkaloids, terfenadine, cyclosporine, hexobarbital and phenytoin) \n\n Specific systemic diseases or other medical conditions that would interfere with the evaluation of the therapeutic response or safety of the study drug \n\n Inability to comprehend and/or unwillingness follow the study protocol \n\n Intentions to leave the vicinity of the trial site in the next 42 days \n\n Prior participation in this study", - "brief_summary": "The primary objective is to confirm the hypothesis that azithromycin (optimal dose once daily for three days) plus chloroquine is non-inferior to sulfadoxine-pyrimethamine plus chloroquine for the treatment of uncomplicated, symptomatic malaria due to P. falciparum.", - "NCTID": "NCT00084240" - }, - { - "brief_title": "The Effect of Oseltamivir Treatment on the Yield of Polymerase Chain Reaction Test for Confirmed Influenza Infection", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Influenza']", - "diseases_list": [ - "Influenza" - ], - "enrollment": "215.0", - "inclusion_criteria": "inclusion criteria: \n\n clinical presentation that suggest influenza virus infection, including sudden onset of high fever, cough, headache, muscle and joint pain, severe malaise, sore throat and runny nose, \n\n positive to influenza virus by PCR test \n\n anti viral treatment was indicated \n\n ", - "exclusion_criteria": ": \n\n Immune compromised patients: patients after solid organ transplant, post bone marrow transplantation, with inherited or acquired immune deficiency, or patients treated chronically with immunosuppressive drugs. \n\n Pregnant women. \n\n Patients who were treated with oseltamivir in the previous 6 months", - "brief_summary": "The purpose of this study is to determine the duration of viral shedding in hospitalized patients with influenza virus, treated with oseltamivir.", - "NCTID": "NCT02334514" - } - ], - "2": [ - { - "brief_title": "Follow-up the Health Condition , Investigation of the Immuno-regulation , and the Study for Interaction of Viral Hepatitis--- Among Patients With or After Dengue Fever Infection", - "phase": "", - "drugs": "['dengue fever']", - "drugs_list": [ - "dengue fever" - ], - "diseases": "['Dengue']", - "diseases_list": [ - "Dengue" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of Dengue Fever", - "exclusion_criteria": "", - "brief_summary": "Originally test host's to understand the tracking healthily and immune change of the dengue fever in Taiwan. Blood drawing 20 c.c for liver examination, kidney and other biochemical function, analyze host immunity adjusts and controls the gene, and the reciprocation that may be produced with the virus hepatitis, besides collected 10 c.c urine at the same time. Urine check is in order to compare acute infect and infected over three month person, the change of chemical composition.~This plan expect to collect 150 healthy, 150 dengue fever infected and 150 dengue fever bleed hot or dengue fever shock disease group's patient, goal to understand health state and immunity of follow-up adjust and control the difference of the gene and the reciprocation may produce to virus hepatitis of light disease and serious disease.", - "NCTID": "NCT00629356" - } - ] - }, - { - "patient_id": "sigir-201524", - "patient": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", - "0": [ - { - "brief_title": "A Global Active Surveillance for Community Acquired Pneumonia", - "phase": "", - "drugs": "['Blood draw', 'Chest X-ray', 'urine specimen', 'Nasopharyngeal swab', 'sputum']", - "drugs_list": [ - "Blood draw", - "Chest X-ray", - "urine specimen", - "Nasopharyngeal swab", - "sputum" - ], - "diseases": "['Community Acquired Pneumonia']", - "diseases_list": [ - "Community Acquired Pneumonia" - ], - "enrollment": "5172.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult subjects 50 years of age or older \n\n Subject must reside in the surveillance area \n\n Subjects who present to a study healthcare facility where the treating physician clinically suspects CAP \n\n ", - "exclusion_criteria": ": \n\n Any subject who is transferred to a study healthcare facility after already being hospitalized for 48 hours or more at any other in-patient facility (such as a community hospital). \n\n Hospital Acquired pneumonia (ie, develops signs and symptoms of pneumonia after being hospitalized for 48 hours or more).", - "brief_summary": "This study is an observational surveillance study to identify adults 50 years and older who present to a study healthcare facility with signs and symptoms of Community-Acquired Pneumonia.", - "NCTID": "NCT00929721" - }, - { - "brief_title": "Chest Physiotherapy in Pediatrics Patients With Pneumonia", - "phase": "", - "drugs": "['Physiotherapy', 'Positioning and cough']", - "drugs_list": [ - "Physiotherapy", - "Positioning and cough" - ], - "diseases": "['Pneumonia']", - "diseases_list": [ - "Pneumonia" - ], - "enrollment": "72.0", - "inclusion_criteria": "inclusion criteria: \n\n Children aged 1 to 12 years with acute community-acquired pneumonia (cough, tachypnea, fever and with a chest radiography with lobar, segmental or bronchopneumonia within the first 48 hours) \n\n ", - "exclusion_criteria": ": \n\n Severely ill patients (hospitalized in intensive care units) \n\n Pleural effusion treated with chest drainage \n\n Atelectasis detected by x-ray \n\n Pneumonia or pleural effusion in the previous six months \n\n Other pulmonary underlying disease, heart disease, cerebral palsy or immune deficiency", - "brief_summary": "Chest physiotherapy has been used to treat pediatric patients hospitalized with pneumonia however there was no evidence to support a beneficial effect in pediatric patients.", - "NCTID": "NCT01017081" - }, - { - "brief_title": "Diagnosing Pneumonia Under Low-resource Conditions", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Asthma', 'Pneumonia', 'Bronchiolitis']", - "diseases_list": [ - "Asthma", - "Pneumonia", - "Bronchiolitis" - ], - "enrollment": "502.0", - "inclusion_criteria": "inclusion criteria: \n\n All children below 5 exceeding WHO age-dependent tachypnea criteria. \n\n ", - "exclusion_criteria": ": \n\n None", - "brief_summary": "Pneumonia is the commonest cause of death in children worldwide, killing 1.5 million children under the age of 5 years, every year. This is more than the number of children dying from AIDS, malaria and tuberculosis combined. The current diagnostic and management protocols for managing serious respiratory diseases in children are 30 years old and are greatly in need of updating. The successful establishment of useful clinical management criteria for children with respiratory diseases will have benefits for children in low resource regions around the world. The goals of the study are:~To determine if children with respiratory distress can be reliably diagnosed under low-resource conditions.~To identify the clinical tests that best differentiate pneumonia from wheezy diseases. These will be used to establish updated diagnostic criteria for common pediatric lung diseases that broaden the current pneumonia algorithm by adding another for wheezy illnesses.~The ultimate objective is to improve the management and outcome of acute respiratory conditions in children.~Investigators also wish to test the efficacy of a locally developed cell phone oximeter probe in a low resource setting.", - "NCTID": "NCT01997047" - }, - { - "brief_title": "Clinical Pediatric Pneumonia Score in Critically Ill Children", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Community Acquired Pneumonia']", - "diseases_list": [ - "Community Acquired Pneumonia" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n All intubated pediatric patients \n\n Age 1 day to 21 years \n\n Admitted to the LLUCH PICU with suspected pneumonia for the next 6 months \n\n Have received antibiotics for less than 12 hours \n\n Have been intubated for less than 24 hours \n\n Patients must be English or Spanish speaking for consent purposes. \n\n ", - "exclusion_criteria": ": \n\n Patients who have received antibiotics for greater than 12 hours \n\n Patients who have been intubated for greater than 24 hours \n\n Patients who are unable to tolerate non-bronchoscopic bronchoalveolar lavage", - "brief_summary": "The purpose of the study is to create a clinical pneumonia tool that can be used to predict the cause of community-acquired pneumonia, which is a lung infection that began outside of the hospital in critically ill children therefore limiting unnecessary antibiotic use. The investigators will enroll critically ill children admitted with acute respiratory failure and suspected pneumonia. Each patient will receive a clinical pneumonia score blinded from culture and respiratory viral panel results. All care after samples obtained will be at the discretion of the PICU team. The investigators believe that our clinical pneumonia scale with procalcitonin will accurately designate viral from bacterial etiologies.", - "NCTID": "NCT02139384" - }, - { - "brief_title": "Corticosteroids in Community-acquired Pneumonia", - "phase": "", - "drugs": "['corticosteroid']", - "drugs_list": [ - "corticosteroid" - ], - "diseases": "['Community-acquired Pneumonia']", - "diseases_list": [ - "Community-acquired Pneumonia" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Children hospitalized for community-acquired pneumonia \n\n 2-18 years old \n\n ", - "exclusion_criteria": ": \n\n Pulmonary chronic disease (including asthma) \n\n Immunodeficiency \n\n Diseases wich requires corticosteroids therapy (i.e. rheumatic diseases) \n\n Wheezing in current disease \n\n Previous hospitalization (14 days prior to admission) \n\n Pleural effusion on admission \n\n Malnutrition", - "brief_summary": "The purpose of this study is to determine the efficacy of addition of corticosteroid therapy to antibiotics in children hospitalized with community-acquired pneumonia.~The hypothesis is that the use of corticosteroids decreases the length of stay in children hospitalized with community-acquired pneumonia.", - "NCTID": "NCT01631916" - }, - { - "brief_title": "Randomized Controlled Trial (RCT) in Children With Severe Pneumonia", - "phase": "", - "drugs": "['Day-care treatment vs. hospital care']", - "drugs_list": [ - "Day-care treatment vs. hospital care" - ], - "diseases": "['Severe Pneumonia']", - "diseases_list": [ - "Severe Pneumonia" - ], - "enrollment": "368.0", - "inclusion_criteria": "inclusion criteria: \n\n Age: 2 to 59 months \n\n Sex: Both boys and girls \n\n Severe pneumonia according to WHO criteria (Severe pneumonia is defined as cough or difficult breathing with lower chest wall in drawing with or without fast breathing which is defined as the respiratory rate \u2265 50 breaths per minute for children aged 2-11 months and \u2265 40 breaths per minute for children aged 12-59 months) \n\n Attend the Radda Clinic and ICHSH between 8:00 am to 4:00 pm (Sunday through Saturday) \n\n Written informed consent by respective parents/guardians \n\n ", - "exclusion_criteria": ": \n\n Very severe and non-severe pneumonia \n\n Nosocomial pneumonia \n\n History of taking antibiotics for pneumonia within 48 hour prior to enrollment \n\n Chronic illnesses like tuberculosis, cystic fibrosis \n\n Congenital deformities/anomalies e.g. Down's Syndrome, congenital heart disease \n\n Immunodeficiency \n\n Trauma/burn \n\n Bronchiolitis \n\n Bronchial asthma \n\n Lives far away from the Radda Clinic and ICHSH (outside 5 km radius from the respective study site) \n\n Parents/guardians not consenting for inclusion of their children in the study", - "brief_summary": "Pneumonia is the leading cause of childhood morbidity and death in many developing countries including Bangladesh, causing about 2 million deaths worldwide each year. Pneumonia is an infection of the lungs, most commonly caused by viruses or bacteria like Streptococcus pneumoniae and Haemophilus influenzae. Depending on the clinical presentation, pneumonia can be classified as very severe, severe or non-severe, with specific treatment for each of them except for antibiotic therapy. Severe and very severe pneumonia require hospitalization for additional supportive treatment such as suction, oxygen therapy and administration of bronchodilator. In Bangladesh, the number of hospital beds is inadequate for admission of all pneumonia cases that require hospitalization; however, it is also important to provide institutional care to those children who cannot be hospitalized due to bed constraints. Provision of appropriate antibiotics and supportive cares during the period of stay at established day-care centres could be an effective alternative. The impetus for this study came from the findings of our recently completed study titled Daycare-based management of severe pneumonia in under-5 children when hospitalization is not possible due to the lack of beds. This study successfully managed children (n=251), but it was not a randomized trial and thus direct comparison of the efficacy of management of severe pneumonia at the day-care centre, essential for building confidence for implementing this management policy, is not possible. We, the researchers at the International Centre for Diarrhoeal Disease Research, Bangladesh, could not plan a randomized, controlled trial (RCT) because of ethical reasons. Now that we have data suggesting effectiveness as well as safety of the day-care based treatment for management of children with severe pneumonia, a RCT should be possible. Two hundred fifty-one children with severe pneumonia were enrolled at the Radda Clinic from June 2003 to May 2005. The mean age was 7\u00b17 (2-55) months, 86% infants, 63% boys and 91% breast-fed. History of cough was present in 99% cases, fever in 89% and rapid breathing in 67% cases. Forty-four percent of children were febrile (\u226538\u00b0C), 93% children had vesicular breath sound and 99% bilateral rales. Fifty-seven percent of children were hypoxic with mean oxygen saturation of (93\u00b14)%, which was corrected by oxygen therapy (98\u00b13)%. Eighty percent of children had severe pneumonia and 20% had very severe pneumonia. The mean duration of clinic stay was (7\u00b12) days. Two hundred thirty-four (93%) children completed the study successfully, 11 (4.4%) referred to hospitals (only one participant had to visit hospital at night due to deterioration of his condition, 9 were referred to hospital at the time of clinic closure i.e., at 5 pm and one participant was referred to hospital during the morning hours) and 6 (2.4%) left against medical advice (LAMA). There was no death during the period of clinic stay but only four (1.6%) deaths occurred during the 3 months follow-up. The study indicated that treatment of severe pneumonia in children at the day-care centre is effective and safe and thus it is comparable to the hospital care. If the day-care based management is found to have comparable efficacy to that of hospitalized management of severe pneumonia in children then they could be managed at outpatient, day-care set ups reducing hospitalization and thus freeing beds for management of other children who need hospitalized care. Additionally, availability of the treatment facility in community set-ups will be cost and time saving for the population. Children of either sex, aged 2-59 months, attending the Radda Clinic and Institute of Child Health and Shishu Hospital (ICHSH) with severe pneumonia will be randomized to receive either the day-care management at the clinic or hospitalized management at the ICHSH. Children randomized to receive day-care treatment will stay at the clinic from 8 am-5 pm and will receive antibiotics and other supportive cares. At 5 pm, they would be send to respective homes with advice to bring back their children to the clinic next morning, and advised to provide other supports at home. The same management would be continued till improvement and discharged and followed up every 2 weeks for 3 months. Children randomized to receive hospitalized management would be admitted at ICHSH and receive standard treatment like antibiotics and other supportive cares. The same treatment would be continued for 24 hours/day (rather than 9 hours/day at the day-care clinic) till improvement and discharged and followed-up at the ICHSH every 2 weeks for 3 months. About 3000 children with pneumonia visit Radda Clinic each year and about 200 of them will have severe pneumonia requiring hospitalization. Thus, we hope to enroll 368 (184 in each site) children with severe pneumonia during a 2-year study period.", - "NCTID": "NCT00455468" - }, - { - "brief_title": "Community Case Management of the Severe Pneumonia With Oral Amoxicillin in Children 2-59 Months of Age", - "phase": "", - "drugs": "['Amoxicillin', 'Referral to Health facility']", - "drugs_list": [ - "Amoxicillin", - "Referral to Health facility" - ], - "diseases": "['Severe Pneumonia']", - "diseases_list": [ - "Severe Pneumonia" - ], - "enrollment": "4070.0", - "inclusion_criteria": "inclusion criteria: \n\n Age between 2 to 59 months who present to LHWs with severe pneumonia. \n\n Informed consent given by a legal guardian. \n\n ", - "exclusion_criteria": ": \n\n Very severe disease. \n\n Persistent vomiting. \n\n Parental or caretaker refusal to participate in the study. \n\n Children currently being treated for non-severe pneumonia who advance to severe pneumonia. \n\n Suspected or known kerosene oil ingestion. \n\n Prior enrollment in the study within 2 weeks of last follow up \n\n Children with severe malnutrition . Children with severe diarrhea with signs of dehydration", - "brief_summary": "Two-arm cluster randomized controlled trial located in Hala district, Pakistan to determine the impact of using Lady Health Workers (LHW) of National Program for Family Planning and Primary Health Care to diagnose and manage severe pneumonia with oral amoxicillin on treatment failure rates at day 6 among 2-59 month old children. LHWs in the control arm receive a refresher in standard pneumonia case management. LHWs in the intervention arm receive standard training that is enhanced to include training in the recognition of severe pneumonia and its home management with oral amoxicillin. Clusters are by Union Council (UC), administrator units consisting of 7 to 25 LHWs; each UC is randomized to either enhanced pneumonia case management with oral amoxicillin therapy (intervention) for severe pneumonia or standard case management and referral to the nearest health facility for treatment (control). Process indicators reflecting the LHW's ability to assess, classify and treat pneumonia in the intervention group and cost-effectiveness data is also being collected.~Primary Hypothesis:~Enhanced pneumonia case management and oral amoxicillin therapy for severe pneumonia delivered by LHWs in the community will result in a reduction in treatment failure among children 2 - 59 months of age with severe pneumonia who are treated by the LHW compared with those referred for care by the LHW.~Secondary Hypotheses:~The proportion of treatment failure, [persistence of lower chest indrawing (LCI) or need for second line treatment between day 3 and day 14], will be less in the intervention arm compared with the control arm.~LHWs can adequately assess, classify, and treat severe pneumonia in 2 - 59 month old children, and adequately recognize and refer children who present with danger signs during initial antimicrobial therapy.", - "NCTID": "NCT01192789" - }, - { - "brief_title": "Trial of Amoxicillin Compared With Placebo for Pneumonia in Children Aged 2-59 Months", - "phase": "", - "drugs": "['Amoxicillin', 'Placebo']", - "drugs_list": [ - "Amoxicillin", - "Placebo" - ], - "diseases": "['Acute Respiratory Infections', 'Pneumonia']", - "diseases_list": [ - "Acute Respiratory Infections", - "Pneumonia" - ], - "enrollment": "900.0", - "inclusion_criteria": "inclusion criteria: \n\n Children aged 2 to 59 months attending the outpatient's clinics of participating sites \n\n WHO defined non-severe pneumonia \n\n Accessibility for follow-up \n\n Written informed consent by a parent or legal guardian \n\n ", - "exclusion_criteria": ": \n\n WHO signs of severe pneumonia recognised by lower chest wall retraction. Children who present with wheezing will be evaluated for lower chest wall indrawing after treatments with nebulised salbutamol. WHO signs of very severe disease/pneumonia defined as any of the following: \n\n Cyanosis \n\n Inability to drink \n\n Convulsions \n\n Abnormally sleepy or difficult to wake \n\n Severe malnutrition recognised by weight for age less than third percentile by the NCHS (National Child Health Statistics) growth chart and/or oedema (see chart). \n\n All patients with a previous history of 3 or more episodes of wheeze or diagnosed to have asthma. \n\n Known or clinically recognisable congenital heart disease with cyanosis or, congestive heart failure or cardiomegaly. \n\n Known or clinically recognisable acute/chronic organ system disorders including jaundice, nephrotic syndrome, severe anaemia manifested as extreme pallor etc. \n\n Other infectious conditions requiring antibiotic therapy at the day of contact including meningitis, tuberculosis, dysentery, osteomyelitis, septic arthritis etc. \n\n Children who have taken the appropriate doses of WHO-recommended dose of anti microbial drug for 48 hours prior to presentation. \n\n A history of hospitalization in the past 2 weeks \n\n Measles or a history of measles within the last month: Measles recognized by presence of fever with rash, and conjunctivitis. \n\n Prior enrolment in the current trial. \n\n Known penicillin allergy, including a history of rash, urticaria, or anaphylactic symptoms. \n\n The children living outside the municipal limits of the city who cannot be followed up.", - "brief_summary": "Many children with non-severe pneumonia (cough and fast breathing) have neither clinical pneumonia as assessed by physicians nor pneumonia on chest radiographs. Inappropriate use of antibiotics for these cases is leading to resistant strains of bacteria in the community. Evidence shows that almost 50% of antibiotic prescription is unnecessary.As over half of antibiotic prescription for ARI are not necessary since most of these infections are viral and do not respond to antibiotic therapy which will be source of resistance in the community.~To address this issue the investigators conducted this randomized, double blind placebo controlled clinical trial of oral Amoxicillin versus placebo in children with non-severe pneumonia taking into account all the necessary safety precautions for their well being.~The study hypothesis was that the clinical outcome of children 2 to 59 months of age with cough and fast breathing (WHO defined non-severe pneumonia) with or without wheezing is equivalent, whether they are treated with amoxicillin or placebo.", - "NCTID": "NCT00851487" - }, - { - "brief_title": "Trial on the Ideal Duration of Oral Antibiotics in Children With Pneumonia", - "phase": "Phase 4", - "drugs": "['Amoxicillin-Potassium Clavulanate Combination', 'Placebo']", - "drugs_list": [ - "Amoxicillin-Potassium Clavulanate Combination", - "Placebo" - ], - "diseases": "['Pneumonia']", - "diseases_list": [ - "Pneumonia" - ], - "enrollment": "19.0", - "inclusion_criteria": "inclusion criteria: \n\n Children admitted with severe pneumonia as defined by the presence of all the following as defined as below: \n\n 3 months to 59 months old \n\n History of cough and/or shortness of breath \n\n Unwell for <= 7 days -Increased respiratory rate ( \u2265 50/min if \u226412 months old, \u2265 40/min) or retractions,- \n\n Any of the following signs/symptoms are present at examination that would necessitate admission: chest retractions, cyanosis, saturation< 92% on air, poor feeding or lethargy \n\n Documented fever (axillary /central temp \u2265 38/38.5\u00b0C) within 24 hrs of admission \n\n Abnormal CXR with presence of alveolar infiltrates \n\n Responds to IV antibiotics by the first 72 hrs and able to go home with oral antibiotics i.e. no more hypoxia and afebrile and reduced respiratory symptoms \n\n ", - "exclusion_criteria": ": \n\n Children who (a) are transferred from another hospital (b) refuse blood taking (c) have a doctor diagnosis of asthma or recurrent wheezing illness (d) have a diagnosis of bronchiolitis i.e. wheezing in a child with a CXR with no consolidation (e) not acute illness ( ie >7 days) (f) unable to come for follow-up (g) not community acquired pneumonia e.g. aspiration pneumonia (h)complicated pneumonia with effusion, pneumothorax, clinical suspicion of necrotizing pneumonia (i)PICU admission or use of Non-invasive ventilation (j)significant comorbidities that can increase the risk of having a complicated pneumonia- (k) need for use of other antibiotics like anti-staph or macrolides (l)extra-pulmonary infection e.g. meningitis (m)allergy to penicillin (n) unable to tolerate oral antibiotics (o) underlying illness that can predispose to recurrent pneumonia \n\n -", - "brief_summary": "To determine, in children hospitalized with pneumonia, if an extended duration of oral antibiotics (10 days) will be superior to a shorter duration (3 days) of antibiotics in improving clinical outcomes.~Secondary Aims:~Describe the prevalence of respiratory viruses and bacteria at presentation.~Investigate the depression, anxiety and stress scores (DASS21) and quality of life scored (QOL) by parents of the children during admission, pre-discharge and post discharge and at follow-ups.", - "NCTID": "NCT02258763" - }, - { - "brief_title": "Community Acquired Pneumonia: Outcome, Quality of Life and Immune Status", - "phase": "Phase 4", - "drugs": "['Prevnar 13']", - "drugs_list": [ - "Prevnar 13" - ], - "diseases": "['Pneumonia', 'Streptococcus Pneumoniae', 'Immune Response']", - "diseases_list": [ - "Pneumonia", - "Streptococcus Pneumoniae", - "Immune Response" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who participated in the Ovidius or Triple-P study (2004-2009). \n\n Diagnosis in these studies with pneumococcal pneumonia or pneumonia due another identified organism. \n\n Age \u2265 18 years. \n\n Signing of informed consent. \n\n ", - "exclusion_criteria": ": \n\n Diagnosis of pneumonia without an identified causative organism. \n\n Fever at time of vaccination. \n\n Previous/known allergic reaction to any of the components of the vaccine given. \n\n Mentally incompetent. \n\n Previous pneumococcal conjugate vaccination. \n\n Pneumococcal polysaccharide vaccination within 6 months prior to inclusion. \n\n Clinical pneumonia within 1 month prior to inclusion.", - "brief_summary": "Community acquired pneumonia (CAP) is an important health problem with significant morbidity, mortality and cost. The most identified pathogen in CAP is Streptococcus pneumoniae. This was also the causative agent most frequently found in the Ovidius and Triple-P study, two consecutive clinical trials initiated by the St. Antonius Hospital Nieuwegein. Diagnosis of pneumococcal pneumonia can be based on positive blood cultures, sputum cultures, urine antigen testing or a serotype specific antibody response. When pneumococcal pneumonia is diagnosed by a positive culture, a matching serotype specific antibody response is expected. However not all patients in the Ovidius and Triple-P study with a culture proven pneumococcal pneumonia showed an antibody response against the infecting pneumococcal serotype. Patients who survived pneumococcal pneumonia are considered as a high-risk population for pneumococcal disease in the future. Possibly these patients have an impaired immune response against S. pneumoniae. In this study, pneumococcal vaccination of patients with S. pneumoniae CAP in the past enables investigating their immune response after vaccination compared to patients with CAP due another causative agent. Furthermore this study provides information to determine if there is a difference in vaccination response between pneumococcal pneumonia patients who had a culture matching serotype specific antibody response and between pneumococcal pneumonia patients who failed to elicit this response previously. Possibly these latter patients had a temporarily low titre due to the infection but another explanation is that there might be a structurally impaired immune response against S. pneumoniae or certain serotypes.", - "NCTID": "NCT02141009" - }, - { - "brief_title": "The Place of Imaging and Microbiology in the Diagnosis of Pneumonia in the Elderly", - "phase": "", - "drugs": "['Low dose CT']", - "drugs_list": [ - "Low dose CT" - ], - "diseases": "['Pneumonia']", - "diseases_list": [ - "Pneumonia" - ], - "enrollment": "203.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients above 65 years old \n\n AND at least one infectious sign: T\u00b0 >38\u00b0C or <35\u00b0C; C-reactive protein (CRP) >10 mg/L; leucocytes >10,000/mL with >85% polynuclear neutrophils or left deviation, \n\n AND at least one respiratory sign: cough; purulent sputum; chest pain; localized crackles; recently appeared dyspnea; oxygen saturation (SpO2) <90%; respiratory frequency >20/min, \n\n AND who will be prescribed antimicrobial therapy for suspicion of low respiratory tract infection, \n\n AND who will give consent himself or through his support person. \n\n ", - "exclusion_criteria": ": \n\n Diagnosis of pneumonia in the previous six months, \n\n AND/OR more than 48h of antimicrobial treatment given before hospitalization, \n\n AND/OR thoracic CT scan performed before hospitalization or inclusion of the patient. \n\n Each patient will be included only once.", - "brief_summary": "Diagnosis of pneumonia in the elderly is difficult because of the poor sensitivity and specificity of clinical signs as well as images from chest radiography (RT). New diagnostic tools such as thoracic low-dose computed tomography (CT), which exposes the patient to a weak dose of irradiation, could improve diagnosis. Moreover, low-dose CT could provide additional accuracy in the etiological clarification of pneumonia in elderly people.~As a first step, the investigators aim to perform a 1 year (12 months of inclusion + 3 months of follow-up) prospective study including the Divisions of Internal Medicine, Rehabilitation, Geriatrics and Radiology of the University Hospitals of Geneva. In this study, patients >65 years old with a clinical suspicion of low respiratory tract infection (LRTI) will be included. They will be prescribed antimicrobial therapy. Both chest radiography and low-dose thoracic CT will be performed within the first 72 hours after admission, as will blood tests and a nasopharyngeal swab.~The clinician's diagnosis, both before and after the results of the CT, will be compared at the end of the study to the adjudication committee's diagnostic opinion which will have access to all available clinical, laboratory and chest X-ray data and which will be considered the gold standard. At the end of the study, all the CT images will be blind-reviewed by two experts in radiology. The impact of CT scanning in the diagnosis of pneumonia will be assessed, both for its sensitivity and specificity in this population.~During the first 12 months of the study, all patients will undergo a systematic nasopharyngeal swab at admission and at discharge, from which eluates will be conserved. During the next 12 months, virological and bacteriological polymerase chain reactions (PCR) will be performed, using new diagnostic tools, in order to determine the etiological diagnosis in this population and to evaluate the impact of the new tools in the management of pneumonia for this population.~Analysis of these data will allow clinical, radiological and microbiological correlation.", - "NCTID": "NCT02467192" - }, - { - "brief_title": "Randomized Trial of Amoxicillin Versus Placebo for (Fast Breathing) Pneumonia", - "phase": "", - "drugs": "['Placebo', 'Amoxicillin']", - "drugs_list": [ - "Placebo", - "Amoxicillin" - ], - "diseases": "['Pneumonia', 'Tachypnea']", - "diseases_list": [ - "Pneumonia", - "Tachypnea" - ], - "enrollment": "4000.0", - "inclusion_criteria": "inclusion criteria: \n\n History of cough or difficult breathing < 14 days (observed or reported) AND \n\n Respiratory rate \u2265 50 breaths per minute in children 2 to <12 months (on two consecutive readings by independent physicians) OR respiratory rate \u2265 40 breaths per minute in children12- 59 months (on two consecutive readings by independent physicians) AND \n\n Written informed consent by a legal guardian \n\n ", - "exclusion_criteria": ": \n\n Previously enrolled in study \n\n Pedal edema \n\n History of hospitalization in last two weeks \n\n With severe lower chest wall in-drawing \n\n Known asthmatics,TB or other severe illness \n\n Antibiotics taken in last 48 hours \n\n Bulging fontanel \n\n Congenital heart disease \n\n Any surgical condition requiring hospitalization \n\n Out of catchment area \n\n Any general danger sign as defined by WHO: Stridor when calm; hypoxia (SaO2 < 90% in air) ; inability to feed; persistent vomiting (after three attempts to feed the baby within \u00bd hour); convulsions; reduced conscious level", - "brief_summary": "The relative benefits and risks of antibiotic therapy in WHO defined fast breathing pneumonia in pre-school children in resource limited settings are controversial both at an individual and public health level. Most infections are viral or self-limiting and non-selective drug treatment has contributed to the global epidemic of antibiotic resistance. There is no high quality trial evidence in managing children with fast breathing in community settings and the WHO itself has called for evidence on which to update guidance. The investigators proposed non inferiority trial comparing standard antibiotic treatment with placebo in poor urban slum settings in South Asia to address this deficit.", - "NCTID": "NCT02372461" - }, - { - "brief_title": "Lung Ultrasound in Pleuritic Chest Pain", - "phase": "", - "drugs": "['Lung ultrasound']", - "drugs_list": [ - "Lung ultrasound" - ], - "diseases": "['Community Acquired Pneumonia', 'Pleuritis', 'Pulmonary Embolism', 'Lung Cancer']", - "diseases_list": [ - "Community Acquired Pneumonia", - "Pleuritis", - "Pulmonary Embolism", - "Lung Cancer" - ], - "enrollment": "400.0", - "inclusion_criteria": "inclusion criteria: \n\n patient aged 18 years and older \n\n patient affected by thoracic pleuritic pain \n\n ", - "exclusion_criteria": ": \n\n patient affected by a chronic condition causing thoracic pain \n\n patient affected by acute cardiovascular diseases (e.g. acute coronary syndrome)", - "brief_summary": "Chest pain is an alarming symptom and one of the most frequent causes of access to the Emergency Departement. Although chest X-ray remains an essential step in the diagnostic process, several studies showed numerous limitations of radiography which frequently is inconclusive. Ultrasonography is a non-radiating imaging technique. Albeit a wide use of ultrasound, the utilization of ultrasound in the study of the lung has only recently been introduced in the clinical practice. Several studies proved that lung ultrasound is useful in the diagnosis of lung consolidation in community acquired pneumonia. Nowadays, ultrasound is not routinely used in the presence of chest pain. Our hypothesis based on clinical experience is that, in patients with pleuritic chest pain, lung ultrasound is very sensitive in detecting pneumonia and other lung diseases (such as pneumothorax) thus performing better than radiography. The primary aim of this study is to verify, in patients affected by pleuritic chest pain, the accuracy of lung ultrasound compared to chest-X-ray. The secondary aim is to evaluate the accuracy of lung ultrasound consolidations in distinguishing lung consolidation in pneumonia, atelectasis, pulmonary infarction, or tumors.", - "NCTID": "NCT02107001" - }, - { - "brief_title": "A Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics of BAYQ3939 in Patients With Bacterial Pneumonia", - "phase": "Phase 3", - "drugs": "['Ciprofloxacin (Cipro, BAYQ3939)']", - "drugs_list": [ - "Ciprofloxacin (Cipro", - "BAYQ3939)" - ], - "diseases": "['Pneumonia']", - "diseases_list": [ - "Pneumonia" - ], - "enrollment": "44.0", - "inclusion_criteria": "inclusion criteria: \n\n Males and non-pregnant, non-lactating females with written informed consent, 20 years of age or older. \n\n Within 48 hours prior to the first study drug administration, all patients should have the pathogens identified with appropriate specimens (e.g., sputum, tracheal aspirate, bronchoalveolar lavage [BAL], protected brushing specimen [PBS]), or should have appropriate specimens highly likely to identify the pathogens sampled. (However, the patients with Legionellosis is enrolled when the test of Legionella antigen is positive.) \n\n The following severe bacterial pneumonia meeting the diagnostic criteria of pneumonia or secondary infection of chronic respiratory disease \n\n Severe pneumonia \n\n Community-acquired pneumonia: PORT score III, IV or V \n\n Hospital-acquired pneumonia [HAP]-Group B and with a low risk for multidrug-resistant pathogens \n\n Patients with [HAP]-Group A whose pathogen is suspected to be Pseudomonas aeruginosa \n\n Hospitalized patients with bacterial pneumonia with a poor response to other antimicrobials Note: The patients should be limited to CAP patients with PORT score III, IV or V and HAP patients with-Group A or B who don't respond to or have a poor response to other antimicrobials over 3day's treatment.2 \n\n Secondary infection of chronic respiratory disease \n\n Patients who are hospitalized for the treatment of secondary infection of chronic respiratory disease \n\n Hospitalized patients with secondary infection of chronic respiratory disease with a poor response to other antimicrobials Note: The patients should be limited to secondary infection of chronic respiratory disease patients who don't respond to or have a poor response to other antimicrobials over 3day's treatment. \n\n ", - "exclusion_criteria": ": \n\n Creatinine clearance (Ccr) \u2264 30 mL/min or nephrotic syndrome \n\n Patient with chronic treatment of immunosuppressive drug \n\n Decompensated congestive heart failure \n\n Subject who received more than 24 hours of an antibacterial drug for the current infection \n\n Patient who requires Intensive Care Unit (ICU) management [In case subjects who don't correspond to the severity for ICU management need to be admitted to ICU due to a circumstance of the site (e.g. shortage of hospital beds), those subjects shall not be excluded] \n\n Patients with infections other than pneumonia or secondary infection of chronic pulmonary disease \n\n Lung abscess, or empyema \n\n Viral, fungal, mycobacterial, or atypical pneumonia as a primary diagnosis \n\n Known or suspected bacteremia secondary to Staphylococcus aureus \n\n Known causative microorganisms other than indication (microorganisms) of the study drug, or positive in urinary antigen test of Streptococcus pneumonia \n\n Infection that necessitates the use of a concomitant antibacterial agent in addition to study medication [excluding subjects with concomitant use of long-term, low-dose macrolide for chronic respiratory diseases, sulbactam sodium/ampicillin sodium (Unasyn-S) and clindamycin (Dalacin-S)] \n\n Known bronchial obstruction or a history of post-obstructive pneumonia \n\n Known primary lung cancer", - "brief_summary": "The main objective of this study is to investigate the safety, pharmacokinetics (PK) and the relationship between PK and pharmacodynamics (Minimum Inhibitory Concentration [MIC] and Mutant Prevention Concentration [MPC]) of intravenous BAYQ3939 (400 mg BID and 400 mg TID) in hospitalized patients with bacterial pneumonia or secondary infection of chronic respiratory disease with severe disease or a poor response to other antimicrobials. In addition, the efficacy of the ciprofloxacin, in terms of clinical response and microbiological response, will be investigated, but as a secondary endpoint.", - "NCTID": "NCT01561794" - }, - { - "brief_title": "Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation", - "phase": "Phase 2", - "drugs": "['aerosolized vancomycin or gentamicin']", - "drugs_list": [ - "aerosolized vancomycin or gentamicin" - ], - "diseases": "['Ventilator Associated Pneumonia', 'Respiratory Infection', 'Tracheobronchitis']", - "diseases_list": [ - "Ventilator Associated Pneumonia", - "Respiratory Infection", - "Tracheobronchitis" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n be on mechanical ventilation greater than 3 days \n\n greater than or equal to 18 years of age survival greater than 14 days \n\n greater than 2 ccs of tracheal secretions/4 hours \n\n ", - "exclusion_criteria": ": \n\n allergy to drugs, pregnancy", - "brief_summary": "The purpose of this study was to determine the effect of aerosolized antibiotics on respiratory infection in mechanically ventilated patients.We hypothesize that aerosolized antibiotics , which achieve high drug concentrations in the airway, would more effectively treat respiratory infection, decrease the need for systemic antibiotics and decrease antibiotic resistance.", - "NCTID": "NCT00396578" - }, - { - "brief_title": "Severe Pandemic H1N1 Infection in ICU: Comparative Resource Utilization", - "phase": "", - "drugs": "['We will compare the resources used by both groups']", - "drugs_list": [ - "We will compare the resources used by both groups" - ], - "diseases": "['Novel H1N1 Influenzal Acute Respiratory Infection']", - "diseases_list": [ - "Novel H1N1 Influenzal Acute Respiratory Infection" - ], - "enrollment": "400.0", - "inclusion_criteria": "inclusion criteria: \n\n > 18years, \n\n Suspected or confirmed influenza (Appendix A) \n\n Requirement for ICU admission due to respiratory distress or critical illness defined as one of:a) Inspired oxygen need of >50% for at least 4 hours (For FiO2 for non-intubated patients see Appendix B) b) mechanical ventilation c) Patient is receiving inotrope or vasopressor \n\n ", - "exclusion_criteria": ": \n\n 1. Age less than 18 years", - "brief_summary": "The main purpose of this study is to review the resource utilization of severe adult H1N1 pneumonia undergoing antiviral and oxygen therapy, mechanical ventilation and support with pulmonary rescue therapies ( nitric oxide, ECMO, HFO) in critically ill patients in Winnipeg. Secondary objectives include, comparison of resource utilization to other similar disorders (viral pneumonia, bacterial pneumonia, septic shock, ARDS). The investigators will also look at the percentage of patients that required ICU care as compared to those who could be cared for on medical wards. The investigators will determine the resources used by both groups and compare. Finally the investigators will record the frequency of chronic comorbidities in hospitalized adult H1N1 patients.", - "NCTID": "NCT01485237" - }, - { - "brief_title": "Preventing Pneumonia and Other Respiratory Problems in Persons With Spinal Cord Injury", - "phase": "Phase 2", - "drugs": "['Manual and mechanical assisted cough', 'Incentive spirometry']", - "drugs_list": [ - "Manual and mechanical assisted cough", - "Incentive spirometry" - ], - "diseases": "['Spinal Cord Injury']", - "diseases_list": [ - "Spinal Cord Injury" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n Chronic spinal cord injury that occurred more than 6 months ago \n\n An impaired ability to cough (cough peak flow less than 300 L/min) \n\n Oxygen saturation greater than or equal to 95% when awake and not receiving supplemental oxygen \n\n End-tidal carbon dioxide level less than 43 mm Hg \n\n Without a fever or other signs of an acute illness for the previous 2 weeks \n\n Able to learn the treatment protocol and have someone available at home to assist if needed to help set-up and use the equipment \n\n ", - "exclusion_criteria": ": \n\n Under 18 years of age \n\n Currently have a tracheotomy tube \n\n Have a history of an acute illness in the last 2 weeks \n\n Have lung disease as seen on chest x-ray that results in a baseline oxygen saturation decreasing below 95% during daytime hours and cannot be normalized by usual way of coughing \n\n Already utilizing an oximetry protocol \n\n Have a significant medical complication and psychiatric condition that would interfere with the conduct of the study or interpretation of the study results.", - "brief_summary": "It is known that individuals with spinal cord injury are at increased risk for respiratory tract infections like pneumonia. Part of this risk is due to weakened chest and abdominal muscles that are vital to deep breathing and the ability to cough. The purpose of this study is to look at the effectiveness of two different treatments in preventing pneumonia and other respiratory problems in persons with SCI.~This is a randomized controlled trial investigating the effectiveness of two different treatments. Participants will be randomly assigned to one of the two treatment groups. They will not be told the details of the other intervention since this could influence or change their activities during the study.", - "NCTID": "NCT00448045" - }, - { - "brief_title": "Errors in Prescription Antibiotics in Ventilator-associated Pneumonia", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pneumonia']", - "diseases_list": [ - "Pneumonia" - ], - "enrollment": "130.0", - "inclusion_criteria": "inclusion criteria: \n\n Be 18 years of age; \n\n Having the diagnosis of ventilator-associated pneumonia. \n\n ", - "exclusion_criteria": ": \n\n Be under 18 years of age;", - "brief_summary": "The infection is a major risk to hospitalized patients, especially those admitted to the Intensive Care Unit (ICU) and an unfavorable factor in the outcome of critically ill patients, increasing costs and prolonging hospitalization hospitalar. The ventilator-associated pneumonia (PAV) is considered the most prevalent nosocomial infection in the ICU, occurring in 9% to 68% of patients with prosthetic ventilat\u00f3ria.Due to the high rate of PAV and mortality related to it, is very important both prescription and administration of antibiotics correctly, as deescalation or escalation according the result of cultures.Therefore, the objectives of this study is assess if whether the antibiotic prescribed of ventilator-associated pneumonia following the orientation of literature. Will also be assessed the rate of PAV in patients critically ill adults, the main microorganisms responsible by PAV and determining antimicrobial susceptibility.", - "NCTID": "NCT02074033" - }, - { - "brief_title": "Flu Vaccine Against Childhood Pneumonia, Bangladesh", - "phase": "Phase 3", - "drugs": "['Trivalent inactivated influenza vaccine']", - "drugs_list": [ - "Trivalent inactivated influenza vaccine" - ], - "diseases": "['Pneumonia', 'Laboratory Confirmed Influenza']", - "diseases_list": [ - "Pneumonia", - "Laboratory Confirmed Influenza" - ], - "enrollment": "3508.0", - "inclusion_criteria": "inclusion criteria: \n\n Children will be included if they are de jure residents 6 months to 23 months old at the time of first dose vaccination residing in households under surveillance. \n\n ", - "exclusion_criteria": ": \n\n Children will be excluded if they have known chronic respiratory, cardiac, or neurological (including seizure disorders) illnesses, are severely malnourished or require hospitalisation for any other reason, are suspected of having tuberculosis (WHO guidelines) [83], are known to have egg allergy, or parents withhold consent.", - "brief_summary": "Pneumonia is the leading cause of child death worldwide. Data from Bangladesh indicates that influenza has a substantial association with pneumonia among children less than two years old. This study will use commercially available trivalent inactivated vaccine (killed vaccine) to see if it can prevent early childhood pneumonia among children less than two years old. The study will vaccinate children across three seasons (3 years), and look at the effect on the attack rate of pneumonia, as well as its effects on laboratory-confirmed influenza. It will also look at the effect on laboratory-confirmed influenza illness among the non-vaccinated household contacts of all ages of these children.", - "NCTID": "NCT01319955" - }, - { - "brief_title": "Diagnostic Value of Lung Ultrasound for Ventilator-Associated Pneumonia", - "phase": "", - "drugs": "['Lung ultrasound examination']", - "drugs_list": [ - "Lung ultrasound examination" - ], - "diseases": "['Ventilator-Associated Pneumonia']", - "diseases_list": [ - "Ventilator-Associated Pneumonia" - ], - "enrollment": "98.0", - "inclusion_criteria": "inclusion criteria: \n\n Mechanical ventilation for at least 48 hours, \n\n New or evolving infiltrate on chest radiograph (CXR) or computed tomography (CT), and \n\n A minimum of two of the following clinical criteria: \n\n Body temperature \u2265 38.5\u00b0 C (101\u00b0 F) or < 36\u00b0 C (97\u00b0 F) \n\n White blood cell count > 10,000/ml or < 4,000/ml or > 10% immature cells \n\n Partial pressure of oxygen in arterial blood < 60 mmHg or partial pressure of oxygen in arterial blood/ inspired oxygen fraction ratio < 300 \n\n Purulent respiratory secretions \n\n ", - "exclusion_criteria": ": \n\n Known ongoing pneumonia \n\n Patient younger than 18 years old \n\n Mechanical ventilation <48 hours \n\n Contraindication to bronchoscopy", - "brief_summary": "Ventilator-associated pneumonia (VAP) is the most common nosocomial infection acquired by mechanically-ventilated patients in the intensive care unit (ICU). It has significant clinical and economic consequences, as it is associated with considerable morbidity, increased mortality, and excess health care costs. Appropriate antibiotic therapy for patients with VAP significantly improves outcomes, making rapid identification of patients with VAP an important clinical goal.~This application is for support of a prospective, multi-centered study to evaluate the diagnostic value of lung ultrasound for VAP. The primary hypothesis is that the association of the Clinical Pulmonary Infection Score (CPIS) to specific lung ultrasound signs could allow for early and reliable diagnosis of bacterial VAP.~Objective 1: To evaluate the sensitivity, specificity, and diagnostic accuracy of lung ultrasound alone and in association with the CPIS.~Objective 2: To determine the frequency of specific lung ultrasound signs (subpleural consolidation, irregular B-lines) in VAP.~Objective 3: To promote development of a diagnostic pathway for VAP incorporating CPIS, lung ultrasound, and unprotected tracheal aspirate (UTA).", - "NCTID": "NCT02244723" - }, - { - "brief_title": "Montelukast for Postinfectious Cough", - "phase": "Phase 2", - "drugs": "['Montelukast']", - "drugs_list": [ - "Montelukast" - ], - "diseases": "['Cough']", - "diseases_list": [ - "Cough" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Cough is the main or only clinical symptom and was persistent for 3-8 weeks \n\n Chest X-ray reveals no noticeable pathological changes \n\n 18 year old, regardless of gender and ethical background \n\n Not taking angiotensin-converting enzyme inhibitor \n\n Patients must join the programme voluntarily and are able to attend examination and follow-up sessions \n\n ", - "exclusion_criteria": ": \n\n Patients diagnosed with allergic rhinitis, chronic nasosinusitis or bacterial respiratory tract infections \n\n Patients diagnosed with severe reportorial disease of other severe systemic disease \n\n Patients who are allergic to any drugs to be tested \n\n Patients who are non-cooperative during examination sessions or other steps of the trial \n\n Patients who are not able to or refuse to sign consent", - "brief_summary": "Cough is a common symptom of respiratory medicine clinic patients, which has complex etiology and wide-ranging. Cough is usually divided into three categories by time: acute cough, subacute cough and chronic cough. Subacute has a 3~8 weeks course of disease. Its main etiology is postinfectious cough, which is mostly secondary to viral infection.Considering its overexpression in postinfectious patient, Cysteinyl leukotriene (CysLTs) plays a role in gathering eosinophils to respiratory. The level of FENO has a significant correlation with inflammatory airway eosinophils. While CysLTs overexpressed in vivo, the level of FENO may increase. Montelukast, as CysLTs-receptor-1 antagonists\uff0c plays a role of controlling airway inflammation and decrease airway high activity by suppressing the biological activity of CysLTs. It is effective in theory to therapy sub-acute cough by Montelukast, to short the course and to relieve cough symptoms as soon as possible. The aim is to research whether FENO can be used as a biomarker to optimized treatment regimen of sub-acute cough.", - "NCTID": "NCT02352545" - }, - { - "brief_title": "Human Safety of Capsaicin Inhalation Challenge Testing for Young and Older Men", - "phase": "Phase 1", - "drugs": "['biological/vaccine']", - "drugs_list": [ - "biological/vaccine" - ], - "diseases": "['COPD']", - "diseases_list": [ - "COPD" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Men of ages 18 and 30 (Dates of birth 1973-1985) or 55-92 years old (Dates of birth 1911-1948). \n\n Must not currently be a cigarette smoker. If an ex-smoker then has not smoked for at least 10 years and consumption were no more than 10 pack years. \n\n Agrees to volunteers for the study and willing to sign the informed consent form. \n\n There were negative/normal screening tests for the following \n\n Responses to the questionnaire deny current and prior respiratory diseases (including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung d9sase) and no current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis). Subjects must not be taking any cardiac medications or admit to a physician-diagnosed cardiac condition. \n\n Normal spirometry measurements with FEV1 & FVC greater than 75% predicted and FEV1/FVC more than 69% \n\n Impedance oscillometry were within normal limits \n\n Negative physical examination of the chest with absence of wheezing and crackles on auscultation of the chest. \n\n Exhaled nitric oxide concentration is less than 35 ppb for younger and less than 65 ppb for older groups \n\n ", - "exclusion_criteria": ": \n\n men of: ages < 18, 31-54 and >92 years old; \n\n current cigarette smokers or exsmokers who have smoked within the past 10 years and/or smoked more than 10 pack/years; \n\n refusal to volunteer for the study and not willing to sign the informed consent form; \n\n screening test not considered normal by physician/PI and showing one or more of the following: \n\n one or more positive response to the questionnaire(e.g., current or past respiratory diseases including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung disease; and/or; current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis) and/or; admitting to taking a cardiac medication and/or; or physician-diagnosed cardiac condition (e.g., coronary heart disease, angina, myocardial infarction, valvular heart disease, cardiomyopathy, etc.); \n\n Abnormal spirometry measurements (FEV1 &/or FVC <75% predicted and FEV1/FVC <69%); \n\n Positive physical examination (performed by Physician/PI) with presence of wheezing and/or crackles on auscultation of the chest; \n\n Impulse oscillometry >4 times normal limits; \n\n Exhaled nitric oxide of >35ppb for younger group and >65 ppb for older group. -", - "brief_summary": "In 2004, the investigators initiated a human Capsaicin inhalation experiment under an Investigational New Drug (IND) protocol approved by the FDA (IND 69,642) and the subject safety procedures instituted and approved by the Institutional Review Board (IRB). As part of the study protocol, inhaled Capsaicin solutions were analyzed using high performance liquid chromatography (HPLC). The investigation employed safety procedures while conducting the human inhalation investigations. In addition, during our investigations we observed discrepancies between the predicted Capsaicin concentrations mixed by a registered pharmacist and the actual capsaicin concentrations determined by HPLC. The stability of Capsaicin solutions stored over a seven month period and refrigerated at 4degrees C and protected against ultraviolet light were examined.", - "NCTID": "NCT01621685" - }, - { - "brief_title": "Trial of Iseganan in Prevention of Ventilator-Associated Pneumonia", - "phase": "Phase 2; Phase 3", - "drugs": "['iseganan hydrochloride']", - "drugs_list": [ - "iseganan hydrochloride" - ], - "diseases": "['Pneumonia']", - "diseases_list": [ - "Pneumonia" - ], - "enrollment": "900.0", - "inclusion_criteria": "inclusion criteria: \n\n Greater than or equal to 18 years of age \n\n Orally/nasally intubated and receiving mechanical ventilation for <24 hours prior to scheduled randomization and administration of the first dose of Study Drug, and in the judgment of the attending physician, expected to remain intubated and mechanically ventilated for at least 48 hours \n\n Expected to survive for at least 21 days and to remain at the investigational site and not transferred to another institution while intubated during the 21-day study period \n\n Willing and able to provide written informed consent, or if unconscious or have altered sensorium, have a surrogate provide written informed consent as approved by the institution \n\n Negative pregnancy test within 7 days prior to randomization if a female of childbearing potential (Negative pregnancy test results [urine or serum] obtained for reason other than the purposes of this study are acceptable.) \n\n ", - "exclusion_criteria": ": \n\n Current diagnosis of pneumonia (Patients currently receiving antibiotics for treatment of pneumonia and patients who meet the study definition of clinically defined pneumonia at the time of screening will be excluded.) \n\n Absolute neutrophil count less than 1000/mm3 \n\n Human immunodeficiency virus infection with a last known CD4 count less than 500/mm3 \n\n Recipient of organ transplantation and receiving immunosuppressive therapy \n\n Current hematologic malignancy \n\n Previously documented cystic fibrosis \n\n Severe cranio-facial trauma or other medical condition expected to require imminent tracheostomy \n\n Patient, patient's family and/or physician not in favor of aggressive medical management or presence of an advanced directive to withhold life-sustaining treatment \n\n Moribund state or expected to survive less than 21 days due to an uncorrectable medical condition \n\n Participation in a clinical trial of any unlicensed drug, biologic or device within 30 days prior to the first dose of study drug \n\n Concurrent participation in a clinical trial of any unlicensed drug, biologic or device.", - "brief_summary": "This is a multinational, double-blind, placebo-controlled trial designed to assess whether iseganan, applied topically to the oral cavity, can prevent ventilator-associated pneumonia among patients who are intubated and mechanically ventilated and survive for up to 14 days.", - "NCTID": "NCT00118781" - }, - { - "brief_title": "Neurophysiology of Cough Reflex Hypersensitivity", - "phase": "", - "drugs": "['Hydrochloric acid (0.15 molar)', 'Saline']", - "drugs_list": [ - "Hydrochloric acid (0.15 molar)", - "Saline" - ], - "diseases": "['Cough', 'Healthy Controls']", - "diseases_list": [ - "Cough", - "Healthy Controls" - ], - "enrollment": "27.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy volunteers inclusion: \n\n Over 18 years \n\n Measurable cough reflex sensitivity - required as is the primary end-point \n\n No current or past history of chronic cough or chronic respiratory disease \n\n Chronic Cough Patients inclusion: \n\n Over 18 years \n\n Chronic persistent cough (> 8 weeks) despite investigation and/or treatment trials for cough variant asthma/post-nasal drip and gastro-oesophageal reflux \n\n Normal chest radiograph - primary respiratory cause for cough excluded \n\n Normal lung function - primary respiratory cause for cough excluded Measurable cough reflex sensitivity - required as primary end-point \n\n ", - "exclusion_criteria": ": \n\n Recent upper respiratory tract infection (<4 weeks) - this can lead to increased sensitivity of the cough reflex which resolves as the infection settles \n\n Pregnancy/breast-feeding - unknown effects of oesophageal acid infusion \n\n Current smokers or ex-smokers with < 6 month abstinence or history > 20 pack years - smoking can alter the sensitivity of the cough reflex \n\n Opiate or ACE inhibitor use or centrally acting medication - can alter the cough reflex sensitivity \n\n Symptomatic gastro-oesophageal reflux, post-nasal drip or asthma (chronic cough cohort may have been treated for these in the past but cough did not resolve) - these conditions are known to cause cough and alter cough reflex sensitivity \n\n Significant ongoing chronic respiratory/cardiovascular/gastro-intestinal/haematological/ neurological/psychiatric illness. We are aiming to recruit healthy volunteers and chronic cough patients who are otherwise healthy", - "brief_summary": "Central sensitisation is an increase in the excitability of nerves within the central nervous system, which can lead to heightened sensitivity to certain stimuli. This process is involved in some chronic pain conditions e.g. migraines and non-cardiac chest pain. Recent work by our group suggests central sensitisation may be an important mechanism leading to chronic cough.~The main questions in this study include:~Can the investigators induce temporary central sensitisation of the cough reflex in healthy volunteers for testing of new medications?~Can the investigators demonstrate exaggerated sensitisation in patients with chronic cough (indicating these patients are already centrally sensitised)?~In animal studies, acid infusion into the gullet (oesophagus) is able to induce central sensitisation of the cough reflex. Acid infusion into the oesophagus has also been shown to induce central sensitisation in human healthy volunteers, increasing the sensitivity to pain on the front of the chest but this study did not test the the cough reflex. Using human participants, the investigators plan to test whether acid infusion into the oesophagus increases the sensitivity of the cough reflex in healthy volunteers and also patients complaining of chronic cough.", - "NCTID": "NCT00977366" - }, - { - "brief_title": "Five Versus Seven Day Antibiotic Course for the Treatment of Pneumonia in the Intensive Care Unit", - "phase": "", - "drugs": "['5 Days of Antibiotics', '7 Days of Antibiotics therapy for pneumonia']", - "drugs_list": [ - "5 Days of Antibiotics", - "7 Days of Antibiotics therapy for pneumonia" - ], - "diseases": "['Pneumonia, Bacterial']", - "diseases_list": [ - "Pneumonia", - "Bacterial" - ], - "enrollment": "46.0", - "inclusion_criteria": "inclusion criteria: \n\n New diagnosis of pneumonia \n\n Patient in medical or surgical intensive care unit \n\n Age greater or equal than 18 years old \n\n ", - "exclusion_criteria": ": \n\n Neutropenia \n\n Recipient of a solid organ or bone marrow transplant \n\n Bacteremia \n\n Presence of Acinetobacter baumannii or Stenotrophomonas maltophilia from a respiratory tract culture \n\n Presence of a second infection requiring antibiotic therapy \n\n Pregnancy \n\n Enrollment in another clinical study \n\n Patient or surrogate unable to provide informed consent \n\n Attending intensive care unit physician declined enrollment in the study", - "brief_summary": "The goal of the study is to determine if patients who are being treated for pneumonia in the intensive care unit can be safely treated with five days of antibiotics (the current standard is seven to eight days). The goal is to determine if the investigators can minimize antibiotic complications while still treating the infection. Patients in the study are randomly assigned to either receive antibiotics for a goal of five days or a goal of seven days. Every patient is followed daily, and if they are not responding to the antibiotics, the treating team in the intensive care unit care can continue the antibiotics for a longer course regardless of what group the patient is assigned. The investigator's hypothesis is that patients in the five day treatment goal will be able to receive less antibiotics than patients in the seven day treatment goal without any adverse effects.", - "NCTID": "NCT01554657" - }, - { - "brief_title": "Bacterial Pulmonary Infection in PICU", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Bacterial Infection']", - "diseases_list": [ - "Bacterial Infection" - ], - "enrollment": "21.0", - "inclusion_criteria": "inclusion criteria: \n\n Parent or legal guardian has signed the informed consent. \n\n Age greater than 48 weeks post-conception and less than 18 years of age. \n\n Requiring mechanical ventilation in the intensive care unit (subjects will not be intubated solely for the purpose of this study). \n\n Presence of an abnormal chest x-ray (CXR) as determined by the primary care team (Note: if the attending radiologist disagrees with the reading of abnormal CXR, the subject will be followed for safety and replaced for analysis). \n\n Initiation of antibiotics by the assigned health care providers for suspected bacterial pneumonia (must be less than or equal to 12 hours prior to undergoing non-bronchoscopic bronchoalveolar lavage [NB-BAL]). \n\n ", - "exclusion_criteria": ": \n\n Presence of severe hypoxia (PaO2/FIO2 < 120). \n\n Documented or suspected increased intracranial pressure. \n\n Hemodynamic instability, defined as one of the following in the 4 hours preceding study entry: \n\n Initiation of any inotropic or vasopressor agents at any dose to improve blood pressure or tissue perfusion. \n\n Increase in infusion rate of any inotropic or vasopressor agents to improve blood pressure or tissue perfusion. \n\n Receipt of intravenous (IV) or oral (PO) antibiotics for suspected bacterial pneumonia for greater than or equal to 12 hours prior to non-bronchoscopic bronchoalveolar lavage (NB-BAL). \n\n Treatment for a previous episode of suspected bacterial pneumonia within three days prior to NB-BAL. \n\n Coagulopathy: \n\n Documented platelet count <50,000 x 10^6/mL at the time of enrollment (Exception: The subject may be enrolled if he/she receives a platelet infusion as a part of routine care that is completed within one hour of NB-BAL initiation), \n\n Extra-corporeal circuit, requiring anticoagulation, or \n\n Clinically apparent bleeding deemed important by either the PI or attending intensivist. \n\n Previous enrollment into this study. \n\n Cardiopulmonary instability during routine suctioning within 6 hours of NB-BAL. \n\n Oscillatory ventilation. \n\n Cystic fibrosis. \n\n Single ventricle physiology. \n\n Positive pleural fluid culture results prior to Day -1 during the current hospitalization.", - "brief_summary": "The purpose of this study is to develop a scoring system to allow doctors to accurately identify children on a mechanical ventilator who have bacterial pneumonia. Currently this diagnosis is very difficult to make, resulting in the overuse of antibiotics and the promotion of antibiotic-resistant bacteria in the pediatric intensive care unit (ICU). Four ICUs at 3 children's hospitals will participate. Study participants will include 150 children, ages 2 months to 17 years old who require mechanical ventilation, and in whom the bedside health care providers suspect bacterial pneumonia. Bacteria will be studied by sampling lung fluid through the breathing tube less than 12 hours after starting antibiotics, using a procedure known as non-bronchoscopic-bronchoalveolar lavage (NB-BAL). Participants may be involved in study related procedures for up to 31 days.", - "NCTID": "NCT00271531" - }, - { - "brief_title": "A Study of the Safety and Effectiveness of Doripenem in Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections", - "phase": "", - "drugs": "['No intervention']", - "drugs_list": [ - "No intervention" - ], - "diseases": "['Pneumonia, Bacterial', 'Nosocomial Infection', 'Intraabdominal Infections', 'Urinary Tract Infection']", - "diseases_list": [ - "Pneumonia", - "Bacterial", - "Nosocomial Infection", - "Intraabdominal Infections", - "Urinary Tract Infection" - ], - "enrollment": "170.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who are diagnosed with nosocomial pneumonia including ventilator-associated pneumonia, complicated intra-abdominal infections or complicated urinary tract infection \n\n Patients who are eligible for doripenem treatment \n\n ", - "exclusion_criteria": ": \n\n Pregnant or lactating females \n\n Patients with hypersensitivity to doripenem and/or its derivatives \n\n Known at study entry to have an infection caused by pathogen(s) resistant to doripenem \n\n Patients taking probenecid \n\n History of severe allergies to certain antibiotics such as penicillins, cephalosporins, and carbapenems \n\n Severe impairment of renal function including a calculated creatinine clearance of less than 10 mL per minute, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (less than 20 mL urine output per hour over 24 hours)", - "brief_summary": "The purpose of this study is to assess the safety and effectiveness of doripenem treatment among Filipino patients with nosocomial pneumonia, complicated intra-abdominal infections, and complicated urinary tract infection.", - "NCTID": "NCT01763008" - }, - { - "brief_title": "Clinical Evaluation of the Response to Chest Physiotherapy in Children With Acute Bronchiolitis", - "phase": "", - "drugs": "['Nebulization of hypertonic saline', 'Prolonged slow expiration technique (PSE)', 'Patient coughing Provocation (TP)', 'inspiratory maneuver to rhinopharyngeal cleaning DRR', 'Aspiration of secretions']", - "drugs_list": [ - "Nebulization of hypertonic saline", - "Prolonged slow expiration technique (PSE)", - "Patient coughing Provocation (TP)", - "inspiratory maneuver to rhinopharyngeal cleaning DRR", - "Aspiration of secretions" - ], - "diseases": "['Bronchiolitis']", - "diseases_list": [ - "Bronchiolitis" - ], - "enrollment": "77.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients admitted to the pediatric intensive care unit or pediatric nursing unit. Which they are diagnostic of acute viral bronchiolitis (AVB). \n\n ", - "exclusion_criteria": ": \n\n Presence of cyanotic congenital heart disease no longer for comparing the constants. \n\n Relative or absolute contraindication CPT techniques included in the protocol. \n\n Patients diagnosed with moderate or severe gastroesophageal reflux since the PSE gastroesophageal reflux can accentuate a previously exist. \n\n Patients with laryngeal diseases caused because the cough is a technique that is applied directly to the tracheal wall and can affect the larynx. \n\n Absence of cough reflects and presence of laryngeal stridor is a contraindication to chest physiotherapy in general. \n\n Systematic presence of gag reflex as the aspiration of secretions and coughing caused nasobucales stimulate this reflex", - "brief_summary": "The objective of this study is to evaluate the clinical response of children diagnosed with acute bronchiolitis, relative to a chest physiotherapy protocol. Comparing this treatment with standard care of the nursing staff and auxiliaries of infants patients aged 1 month to 2 years.", - "NCTID": "NCT02458300" - }, - { - "brief_title": "Fractional Concentration of Exhaled NO(FENO) to Direct Montelukast Treatment of Sub-acute Cough", - "phase": "", - "drugs": "['Montelukast', 'Placebo']", - "drugs_list": [ - "Montelukast", - "Placebo" - ], - "diseases": "['Coughing']", - "diseases_list": [ - "Coughing" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Cough is the main or only clinical symptom and was persistent for 3-8 weeks \n\n Chest X-ray reveals no noticeable pathological changes \n\n \u226518 year old, regardless of gender and ethical background \n\n Not taking angiotensin-converting enzyme inhibitor \n\n Patients must join the programme voluntarily and are able to attend examination and follow-up sessions \n\n ", - "exclusion_criteria": ": \n\n Patients diagnosed with rhinallergosis, chronic nasosinusitis or bacterial respiratory tract infections \n\n Patients diagnosed with severe reportorial disease of other severe systemic disease \n\n Patients who are allergic to any drugs to be tested \n\n Patients who are non-cooperative during examination sessions or other steps of the trial \n\n Patients who are not able to or refuse to sign consent", - "brief_summary": "Cough is a common symptom of respiratory medicine clinic patients, which has complex etiology and wide-ranging. Cough is usually divided into three categories by time: acute cough, subacute cough and chronic cough. Subacute has a 3~8 weeks course of disease. Its main etiology is postinfectious cough, which is mostly secondary to viral infection.Considering its overexpression in postinfectious patient, Cysteinyl leukotriene (CysLTs) plays a role in gathering eosinophils to respiratory. The level of FENO has a significant correlation with inflammatory airway eosinophils. While CysLTs overexpressed in vivo, the level of FENO may increase. Montelukast, as CysLTs-receptor-1 antagonists\uff0c plays a role of controlling airway inflammation and decrease airway high activity by suppressing the biological activity of CysLTs. It is effective in theory to therapy sub-acute cough by Montelukast, to short the course and to relieve cough symptoms as soon as possible. The aim is to research whether FENO can be used as a biomarker to optimized treatment regimen of sub-acute cough.", - "NCTID": "NCT02303600" - }, - { - "brief_title": "A Study on the Mechanism of Cough Hypersensitivity", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Cough']", - "diseases_list": [ - "Cough" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n chronic cough group: \n\n cough lasting \u2265 8 weeks,characterized by irritating dry cough. \n\n sensitive to fumes\uff0cdust,the odorous and cold air. \n\n with normal chest x-rays. 4.17-70 years old. \n\n 5.without smoking history. healty controls group: 1.17-70 years old. 2.without smoking hitory or stop smoking for more than 2 years. 3.without chronic cough. 4.without chronic respiratory diseases. 5.without chronic heart, liver, kidney,and autoimmune disease. 6.with normal chest x-rays. 7.with normal pulmonary ventilation function,and histamine challenge test showed negative result. \n\n ", - "exclusion_criteria": ": \n\n chronic cough group and healty controls group: \n\n with respiratory tract infection within 8 weeks. \n\n with chronic respiratory diseases or severe heart, liver, kidney,and autoimmune disease. \n\n using Angiotensin-Converting Enzyme Inhibitors(ACEI),bronchodilators,glucocorticosteroid,antihistaminics within one week. \n\n women during pregnancy or lactation. \n\n patients with malignant tumours.", - "brief_summary": "The aim of this study is described as follows,~To establish a validated method to test cough reflex sensitivity conducted by transient receptor potential vanilloid 1(TRPV1).~To observe the variance of cough reflex sensitivity conducted by transient receptor potential ankyrin 1(TRPA1) of chronic patients and the relationship between cough reflex sensitivity conducted by TRPA1 and conducted by TRPV1.~To study the distribution of TRPA1 and TRPV1 channels and their relationship to cough reflex sensitivity.", - "NCTID": "NCT02591550" - }, - { - "brief_title": "Preliminary Study of Dornase Alfa to Treat Chest Infections Post Lung Transplant.", - "phase": "Phase 2", - "drugs": "['Dornase Alfa', 'Isotonic Saline.']", - "drugs_list": [ - "Dornase Alfa", - "Isotonic Saline." - ], - "diseases": "['Lung Transplant Infection', 'Lower Respiratory Tract Infection']", - "diseases_list": [ - "Lung Transplant Infection", - "Lower Respiratory Tract Infection" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n Post bilateral sequential lung transplant \n\n Capable of performing airway clearance techniques / nebulisers \n\n Pulmonary exacerbation as defined by Fuchs et al \n\n Must be productive of sputum \n\n Able to provide informed consent within 48 hours of presentation. \n\n *Fuchs Scale(8): Treatment with / without parenteral antibiotics for 4/12 signs and symptoms: \n\n Change in sputum \n\n New or increased haemoptysis \n\n Increased cough \n\n Increased dyspnoea \n\n Malaise, fever or lethargy \n\n Temp above 38 \n\n Anorexia or weight loss \n\n Sinus pain or tenderness \n\n Change in sinus discharge \n\n Change in physical examination of the chest \n\n Radiographic changes indicative of pulmonary infection \n\n Decrease in pulmonary function by 10 % or more \n\n ", - "exclusion_criteria": ": \n\n Paediatric transplant <18yrs \n\n Single lung transplant - native lung physiology may confound outcome measures \n\n Interstate - unable to complete follow up \n\n Unable to perform lung function testing \n\n Unable to complete subjective outcome measures- unable to read English fluently \n\n Critically unwell / intensive care unit / ventilator dependent \n\n Within 2 months of transplant date *Cystic Fibrosis will be stratified", - "brief_summary": "Patients who have undergone lung transplantation are at an increased risk of developing chest infections due to long-term medication suppressing the immune response. In other chronic lung diseases such as cystic fibrosis (CF) and bronchiectasis, inhaled, nebulised mucolytic medication such as dornase alfa and isotonic saline are often used as part of the management of lung disease characterized by increased or retained secretions. These agents act by making it easier to clear airway secretions, and are currently being used on a case-by-case basis post lung transplantation.~To the investigators knowledge, these agents have not been evaluated via robust scientific investigation when used post lung transplant, yet are widely used in routine practice. Patients post lung transplant must be investigated separately as they exhibit differences in physiology that make the clearance of sputum potentially more difficult when compared to other lung diseases. Lower respiratory tract infections are a leading cause of hospital re-admission post lung transplant. Therefore, this highlights the need for a randomized controlled trial. The aim of this study is to assess the efficacy of dornase alfa, compared to isotonic saline, in the management of lower respiratory tract infections post lung transplant. Investigators hypothesize that dornase alfa will be more effective than isotonic saline.~The effect of a daily dose of dornase alfa and isotonic saline will be compared over a treatment period of 1 month. Patients admitted to hospital suffering from chest infections characterized by sputum production post lung transplant will be eligible for study inclusion. Patients will be followed up through to 3 months in total to analyze short-medium term lasting effect. Investigators wish to monitor physiological change within the lung non-invasively via lung function analysis whilst assessing patient perceived benefit via cough specific quality of life questionnaires. These measures will be taken at study inclusion and repeated after 1 month and 3 months. Day to day monitoring will be performed via patient symptom diaries, incorporating hospital length of stay and exacerbation rate. The outcomes of this study have the potential to guide clinical decision-making and highlight safe and efficacious therapies.", - "NCTID": "NCT01952470" - }, - { - "brief_title": "Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients", - "phase": "Phase 4", - "drugs": "['Sultamicillin']", - "drugs_list": [ - "Sultamicillin" - ], - "diseases": "['Ventilator Associated Pneumonia']", - "diseases_list": [ - "Ventilator Associated Pneumonia" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients admitted to intensive care units,with score in the Glasgow Coma scale less than nine. \n\n Requiring mechanical ventilation for more than 48 hours \n\n Includes all patients with structural or metabolic coma \n\n ", - "exclusion_criteria": ": \n\n Pregnant women \n\n History of allergic reactions to ampicillin sulbactam \n\n Patients admitted as potential organ donors \n\n Patients with an indication of antibiotic therapy, or who have received more than 2 doses of any antibiotic previously. \n\n Hospital stay for more than 48 hours before intubation.", - "brief_summary": "This study seeks to assess whether coma patients really benefit from the use of antibiotics as a prophylactic for reducing the incidence of early ventilator-associated pneumonia in this population group. For this we consider the use of ampicillin sulbactam antibiotic which has a low ability to induce resistance, efficacy and safety observed during the time that has been used, even in patients with neurosurgical pathology, and to be broadly available in our environment.~Our hypothesis is that neurological patients in coma state, requiring mechanical ventilation, the application of antibiotic prophylaxis compared with placebo reduces the incidence of early ventilator-associated pneumonia.", - "NCTID": "NCT01118403" - }, - { - "brief_title": "A Study of Two Forms of Pentamidine in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS", - "phase": "", - "drugs": "['Pentamidine isethionate']", - "drugs_list": [ - "Pentamidine isethionate" - ], - "diseases": "['Pneumonia, Pneumocystis Carinii', 'HIV Infections']", - "diseases_list": [ - "Pneumonia", - "Pneumocystis Carinii", - "HIV Infections" - ], - "enrollment": "", - "inclusion_criteria": "", - "exclusion_criteria": " \n\n Co-existing Condition: \n\n Patients with the following are excluded: \n\n Previous history of adverse reaction to pentamidine. \n\n History of asthma. \n\n Pulmonary Kaposi's sarcoma. \n\n Patients with the following are excluded: \n\n Previous history of adverse reaction to pentamidine. \n\n History of asthma. \n\n Pulmonary Kaposi's sarcoma. \n\n Inability to understand the consent procedure. \n\n All patients hospitalized at Cedars-Sinai Medical Center with AIDS and possible Pneumocystis carinii pneumonia (PCP) will be eligible. \n\n Patients with HIV antibody or AIDS and a clinical presentation suggesting PCP are eligible.", - "brief_summary": "To compare parenteral versus inhaled pentamidine in patients with documented Pneumocystis carinii pneumonia (PCP) with AIDS.", - "NCTID": "NCT00002292" - }, - { - "brief_title": "A Clinico-Bacteriological Study and Effect of Stress Ulcer Prophylaxis on Occurrence of Ventilator Associated Pneumonia", - "phase": "Phase 4", - "drugs": "['Ranitidine', 'Sucralfate']", - "drugs_list": [ - "Ranitidine", - "Sucralfate" - ], - "diseases": "['Ventilator Associated Pneumonia', 'Etiological Organisms', 'Antimicrobial Drug Susceptibility Pattern', 'Stress Ulcer Prophylaxis']", - "diseases_list": [ - "Ventilator Associated Pneumonia", - "Etiological Organisms", - "Antimicrobial Drug Susceptibility Pattern", - "Stress Ulcer Prophylaxis" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Age greater than 12 years \n\n Those on mechanical ventilation for more than 48 hours. \n\n ", - "exclusion_criteria": ": \n\n Pre-existing pneumonia at the beginning of ventilation or \n\n Developing pneumonia within 48 hours of ventilation. \n\n Patients on oral antibiotics", - "brief_summary": "Objective of this study was to determine incidence, risk factors, etiological micro-organisms and their antimicrobial susceptibility pattern and outcome of VAP; and to study effect of ranitidine vs. sucralfate, used for stress ulcer prophylaxis, on gastric colonization and on occurrence of VAP.~Methods: Design: Prospective randomized study. Setting: ICUs of Medicine Department and Anesthesiology Department, Maulana Azad Medical College and Lok Nayak Hospital, University of Delhi, New Delhi. Patients: 50 patients of age more than 12 years, who had been on ventilator for more than 48 hrs. Intervention: Endotracheal Aspirate and blood sample of all patients were cultured to determine micro-organisms causing VAP and their antimicrobial susceptibility pattern. Patients were divided into 2 groups on random basis. The first group was given ranitidine for stress ulcer prophylaxis while the second was given sucralfate. Thereafter, difference in gastric colonization (on basis of quantitative culture of nasogastric aspirate) and on occurrence of VAP in both the groups was compared.~Study Hypothesis: Study was designed to create data about Ventilator associated pneumonia in developing countries like India. This data is crucial for providing information for deciding future guidelines for treatment of and prevention of Ventilator associated pneumonia. Further to test the hypothesis that H2 blockers, by virtue of raising gastric Ph, increase gastric colonization by pathogenic organism and increase incidence of Ventilator associated pneumonia; patients were divided into two groups on random basis, as described above.", - "NCTID": "NCT00702871" - }, - { - "brief_title": "Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity", - "phase": "", - "drugs": "['ketamine']", - "drugs_list": [ - "ketamine" - ], - "diseases": "['Chronic Cough']", - "diseases_list": [ - "Chronic Cough" - ], - "enrollment": "24.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy Volunteers: \n\n Over 18 years old \n\n Measurable cough reflex sensitivity \n\n No current or past history of chronic cough or chronic respiratory disease. \n\n No symptoms of gastro-oesophageal reflux disease, asthma or post-nasal drip. \n\n Chronic Cough Patients \n\n Over 18 years old \n\n Chronic persistent cough (> 8 weeks) despite investigation and/or treatment trials for cough variant asthma/post nasal drip and gastro-oesophageal reflux disease. \n\n Normal CXR \n\n Normal lung function \n\n Measurable cough reflex sensitivity \n\n ", - "exclusion_criteria": ": \n\n Recent Upper Respiratory Tract Infection (4 weeks) \n\n Pregnancy/breast feeding \n\n Current smokers or ex-smokers with < 6 months abstinence or cumulative history of > 10 packyears \n\n Diabetes Mellitus \n\n Opiate or ACE Inhibitor use. \n\n Any centrally acting medication which has the potential to alter cough reflex sensitivity. \n\n Significant and ongoing chronic respiratory, cardiovascular (in particular hypertension), gastro-intestinal, haematological (porphyria), neurological or psychiatric illness. \n\n Drug or alcohol abuse \n\n History of allergy or reaction to ketamine of other NMDA receptor antagonists.", - "brief_summary": "A cough lasting more than 2 months is known as a chronic cough, affecting 12-23% of the adult non-smoking population. Chronic cough has many associated complications including incontinence, muscular chest pains, blackouts and depression. Current treatment is often ineffective in these patients. To develop new medications the investigators need to understand more about the mechanisms that can lead to excessive coughing.~This study plans to compare a group of 12 healthy volunteers and 12 patients with a chronic cough. The investigators hypothesise that that chronic cough patients have a more sensitive cough reflex as a result central nervous system hyper-excitability (central sensitisation). The investigators will measure cough reflex sensitivity before and after administration of ketamine, a medication that blocks an important receptor in the central nervous system.", - "NCTID": "NCT00858624" - }, - { - "brief_title": "A Study of CNTO 3157 in Healthy Normal and Asthmatic Participants Inoculated With Human Rhinovirus Type 16", - "phase": "Phase 1", - "drugs": "['CNTO 3157 (healthy participants)', 'Placebo (healthy participants)', 'CNTO 3157 (asthmatic patients)', 'Placebo (asthmatic patients)', 'HRV-16']", - "drugs_list": [ - "CNTO 3157 (healthy participants)", - "Placebo (healthy participants)", - "CNTO 3157 (asthmatic patients)", - "Placebo (asthmatic patients)", - "HRV-16" - ], - "diseases": "['Healthy Volunteers and Asthma']", - "diseases_list": [ - "Healthy Volunteers and Asthma" - ], - "enrollment": "76.0", - "inclusion_criteria": "inclusion criteria: \n\n Understanding of the study and a signed informed consent form before any study-related procedures \n\n Willing and able to adhere to the restrictions specified in the protocol \n\n Results of the following laboratory tests within the following limits: serum alanine aminotransferase (ALT) levels \u22642 x ULN; serum aspartate aminotransferase (AST) levels \u22642 x ULN \n\n Part 1 (healthy participants): \n\n a). Body weight in the range of 40 to 125 kg, inclusive. Have a body mass index (BMI) of 19 to 32 kg/m2, inclusive \n\n b). Healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments, coagulation and urinalysis, measurement of vital signs, and 12-lead electrocardiogram (ECG) performed at Screening Visit 2 \n\n Part 2: \n\n a). (BMI) of 19 to 40 kg/m2, inclusive; have a physician-documented diagnosis of asthma for at least 6 months prior to Screening Visit 2; have stable asthma based on physician assessment at Screening Visit 2 \n\n b). Have an Asthma Control Questionnaire (ACQ) symptom score less than (<)2.5 at Screening Visit 2 \n\n c). Have a prebronchodilator forced expiratory volume in the first second (FEV1) greater than or equal to (>=) 65 percent of predicted normal value at Screening Visit 2 \n\n ", - "exclusion_criteria": ": \n\n Part 1 (healthy participants): Has any condition that in the opinion of the investigators, would constitute a risk or a contraindication for participating in the study, prevent the participant from meeting or performing study requirements, or could interfere with the study objectives, conduct, or evaluation \n\n At Screening Visit 1 and throughout the study, works with (or lives with a family member who cares for) the elderly, (eg, nursing home), or lives with someone who may be at risk from transmission of the human rhinovirus type 16 (HRV-16) challenge agent, including, but not limited to, individuals with chronic lung disease (including asthma), a premature infant, or an immunocompromised individual \n\n Has had any acute illness, including a common cold, within 4 weeks prior to Screening Visit 1, or has had a major illness or hospitalization within 6 months prior to Screening Visit 1 \n\n Has active allergic rhinitis or perennial allergy symptoms (eg, due to ragweed) at Screening Visit 2 or expects to have active allergic rhinitis or perennial allergy symptoms during the study \n\n Has a current infection (eg, sepsis, pneumonia or pyelonephritis), or has been hospitalized and/or received antimicrobials for a serious infection during the 6 months prior to Screening Visit 1 \n\n Part 2 (asthmatic patients): Has a history of any other chronic lung disease, including chronic obstructive pulmonary disease (COPD), bronchiolitis, bronchiectasis, allergic bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea, pulmonary hypertension, or any other obstructive pulmonary disease, liver or renal insufficiency; significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, or other body system disorders that are clinically significant in the opinion of the investigator \n\n Has ever had an episode of life-threatening asthma defined as respiratory arrest or requiring intubation for asthma \n\n Has been hospitalized (for greater than 24 hours) due to asthma in the 5 years prior to Screening Visit 1 \n\n Has experienced an asthma exacerbation in the 12 weeks prior to Screening Visit 1 requiring management with systemic steroids \n\n Is receiving a high-dose inhaled corticosteroid (ICS) (>500 \u00b5g/day to fluticasone or equivalent). Use of low or medium dose ICS (\u2264500 \u00b5g/day fluticasone or equivalent) with or without permitted controller medications, eg, long-acting Beta2 agonists (LABA), leukotriene receptor antagonists (LTRA), is allowed", - "brief_summary": "The main purposes of this study are to evaluate the safety (Parts 1 and 2) and efficacy (Part 2) of pretreatment with CNTO 3157 in healthy adult and asthmatic adult participants before and after intranasal (into the nose) inoculation with human rhinovirus type 16 (HRV-16).", - "NCTID": "NCT01704040" - }, - { - "brief_title": "Randomized Controlled Trial of Doxycycline to Prevent Acquisition of Mycoplasma Pneumoniae in an Outbreak Setting", - "phase": "", - "drugs": "['Doxycycline treatment']", - "drugs_list": [ - "Doxycycline treatment" - ], - "diseases": "['Mycoplasma Pneumoniae']", - "diseases_list": [ - "Mycoplasma Pneumoniae" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n - Working at hospital facility where outbreak of Mycoplasma pneumoniae occured \n\n ", - "exclusion_criteria": ": \n\n - Pregnant, on antiseizure medications, allergic to macrolide antibiotics", - "brief_summary": "This study was designed to determine whether taking daily doxycycline during an outbreak of Mycoplasma pneumoniae could prevent a person from getting infected and interrupt ongoing disease transmission during an outbreak. Doxycycline is a treatment for Mycoplasma pneumoniae, but it is not certain that the drug could prevent disease if used prophylactically.", - "NCTID": "NCT00207584" - }, - { - "brief_title": "Study Evaluating Streptococcus Pneumoniae Serotype Carriage Rate for Nasopharyngeal Carriage in Filipino Children", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pneumonia, Bacterial']", - "diseases_list": [ - "Pneumonia", - "Bacterial" - ], - "enrollment": "500.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy children aged between 2 months and 5 years attending the well baby clinic in hospital. \n\n Informed consent obtained from parents or legal guardian.", - "exclusion_criteria": "", - "brief_summary": "Evaluation of the carriage rate of Streptococcus pneumoniae in the nasopharynx of healthy children and the carriage rate and distribution of Streptococcus pneumoniae serotypes", - "NCTID": "NCT00724828" - }, - { - "brief_title": "Dexamethasone to Treat Acute Chest Syndrome in People With Sickle Cell Disease", - "phase": "Phase 3", - "drugs": "['Dexamethasone', 'Placebo']", - "drugs_list": [ - "Dexamethasone", - "Placebo" - ], - "diseases": "['Anemia, Sickle Cell']", - "diseases_list": [ - "Anemia", - "Sickle Cell" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of sickle cell anemia (Hgb SS) or sickle-\u03b20-thalassemia (Hgb S\u03b20) \n\n Current episode of ACS, defined as a new lobar or segmental pulmonary infiltrate seen on a chest radiograph and two or more of the following findings: \n\n Temperature of 38.5\u00b0C or higher \n\n Tachypnea (i.e., rapid breathing) \n\n Dyspnea or increased work of breathing \n\n Chest wall pain \n\n Oxygen saturation of less than 90% in room air by pulse oximetry \n\n Current episode of ACS diagnosed in the 24 hours prior to study entry \n\n Ability to take medication in capsule form \n\n ", - "exclusion_criteria": ": \n\n Prior participation in this study \n\n Diagnosed with any medical condition that will likely be worsened by corticosteroid therapy, including any of the following conditions: \n\n Diabetes mellitus \n\n High blood pressure \n\n Esophageal or gastrointestinal ulceration or bleeding \n\n Known avascular necrosis \n\n Diagnosis of ACS in the 6 months prior to study entry \n\n Treatment with oral or parenteral corticosteroid therapy for any reason in the 14 days prior to study entry \n\n Use of inhaled corticosteroids or systemic corticosteroids for respiratory illness in the 3 months prior to study entry \n\n Long-term lung condition that requires treatment with corticosteroids \n\n Participation in a program of chronic transfusions that ended fewer than 4 months ago. A program of chronic transfusions includes a regimen of serial simple or exchange transfusions given at least every 6 weeks for at least three consecutive transfusions for the prevention of SCD-related complications. \n\n Pregnant \n\n Treatment with any investigational drug in the 90 days prior to study entry \n\n History of either tuberculosis or a positive skin test for tuberculosis \n\n Known HIV infection or a current systemic fungal infection", - "brief_summary": "People with sickle cell disease (SCD) may develop acute chest syndrome (ACS), which is a common and serious lung condition that usually requires hospitalization. Dexamethasone is a medication that may decrease hospitalization time for people with ACS, but it may also bring about new sickle cell pain. This study will evaluate the effectiveness of a dexamethasone regimen that includes a gradual dose reduction at decreasing hospitalization and recovery time in people with SCD and ACS.", - "NCTID": "NCT00530270" - }, - { - "brief_title": "The Effects of Sound Energy on Pulmonary Gas Exchange", - "phase": "", - "drugs": "['Induction of sound waves in lungs by sonic oscillator']", - "drugs_list": [ - "Induction of sound waves in lungs by sonic oscillator" - ], - "diseases": "['Respiratory Failure']", - "diseases_list": [ - "Respiratory Failure" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy male or female volunteers in the age group. \n\n ", - "exclusion_criteria": ": \n\n Any acute or chronic cardiopulmonary disorder including a simple common cold.", - "brief_summary": "Study of the effects of sonic pressure oscillations on pulmonary gas exchange with added dead space.", - "NCTID": "NCT02447731" - }, - { - "brief_title": "Prevention of Bacterial Infections in Newborn", - "phase": "Phase 3", - "drugs": "['Azithromycin and Placebo']", - "drugs_list": [ - "Azithromycin and Placebo" - ], - "diseases": "['Neonatal Infection']", - "diseases_list": [ - "Neonatal Infection" - ], - "enrollment": "829.0", - "inclusion_criteria": "inclusion criteria: \n\n Pregnant women (aged 18 to 45 years) \n\n in labour \n\n attending a health centre in western Gambia for delivery \n\n ", - "exclusion_criteria": ": \n\n Known HIV infection. \n\n Any chronic or acute conditions of the women that might interfere with the study as judged by the research clinician. \n\n Planned travelling out of the catchment area during the following 2 months (follow-up period) \n\n Planned caesarean section \n\n Known required referral \n\n Known multiple pregnancy \n\n Known severe congenital malformation \n\n Intrauterine death confirmed before randomization \n\n Known allergy to macrolides \n\n Consumption of antibiotic within the week before randomisation", - "brief_summary": "The last decade has witnessed an important reduction of the mortality in children under 5 years but such reduction has not impacted in neonates. Mortality in neonates contributes 40% of all deaths occurring in children below 5 years of age.~Severe bacterial disease is among the leading causes of neonatal deaths. Bacterial disease follows bacterial infection. Individuals can be infected without developing disease (carriage stage) but infection is needed to subsequently develop disease. In sub-Saharan Africa, bacterial carriage (i.e. in the birth canal and/or nasopharyngeal tract) is very common in all age groups, with the consequence that occurrence of bacterial disease is one of the highest in the world.~Newborns can be infected during labour - when passing through the birth canal - and during the first days/weeks of life, as a consequence of the close physical contact with the mother, if the latter carries bacteria in the nasopharyngeal tract.~If the mother is an important source of bacterial infection to the newborn, treating mothers with a powerful antibiotic during labour should decrease bacterial carriage and therefore diminish the risk of bacterial transmission to the newborn during the first days/weeks of life, which should in turn result in the lower occurrence of severe bacterial disease and hence lower mortality.~The purpose of this trial is to evaluate the impact of a single oral dose of azithromycin given to women in labour on bacterial carriage of the newborn as well as the women during the first month after delivery.~The investigators have selected an antibiotic (azithromycin) that in sub-Saharan Africa has already shown both a strong impact on bacterial nasopharyngeal carriage and on all-cause mortality when administered to everybody in a community (mass drug administration). This specific antibiotic has several advantages for being deployable as a simple intervention in rural Africa, i.e. it requires a single oral administration, it has no special storage requirements and it has the potential to eliminate many of the bacteria commonly causing severe disease in newborn.~This clinical trial will be conducted in a peri-urban health facility in Western Gambia. If an impact is shown, the next step would be to conduct a larger study aiming at establishing if the intervention, implemented at a lower level of care (most African women deliver at home assisted by traditional birth assistants), decreases the occurrence of neonatal bacterial disease", - "NCTID": "NCT01800942" - }, - { - "brief_title": "Bedside Lung Ultrasound in Young Children Presenting to the Emergency Department (ED) With Wheezing", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Wheezing', 'Bronchiolitis']", - "diseases_list": [ - "Wheezing", - "Bronchiolitis" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Age less than or equal to 24 months \n\n Presenting to the pediatric ED with wheezing \n\n ", - "exclusion_criteria": ": \n\n On home oxygen at baseline \n\n Cyanotic congenital cardiac disease (including: ToF, TAPVR, HLHS, d-TGA, TA, pulm atresia, critical pulm stenosis, but not including VSD, ASD, Coarctation of the Aorta) \n\n Endotracheal tube or tracheostomy in place and/or receiving mechanical ventilation \n\n Transferred from an outside hospital", - "brief_summary": "Young children presenting to the Emergency Department (ED) with wheezing often have prolonged stays in the ED or even get admitted to the hospital. This is a prospective observational study in which the investigators will use bedside 2D ultrasound to evaluate the lung ultrasound findings in children less than 24 months presenting to the ED with wheezing.~The investigators hypothesize that children less than 24 months presenting to the Emergency Department with wheezing will have a range of lung ultrasound findings that will include normal findings, B lines, subpleural consolidations, and pleural effusions. The investigators also hypothesize that the findings will be reproducible between two equally trained providers.~The investigators also hypothesize that lung ultrasound findings patients 0-24 months presenting to the ED with wheezing will correlate with specific clinical outcomes. An exploratory analysis will be performed to look for correlations between lung US findings and acute severity, final diagnosis, presenting symptoms, prematurity, risk factors for atopy, response to treatment and radiologic or viral studies if performed.", - "NCTID": "NCT01452945" - }, - { - "brief_title": "Capsaicin Cough Threshold in Chronic Cough Due to Postnasal Drip", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Post Nasal Drip']", - "diseases_list": [ - "Post Nasal Drip" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n - \n\n Postnasal Drip with chronic cough: \n\n Postnasal drip by rhinoscopy \n\n Cough by visual analog scale. \n\n Patients have to be 18 years old or older. \n\n Cough-variant asthma must be excluded by a negative methacholine challenge test within one year, or documented failure of chronic cough to resolve after administration of inhaled corticosteroid (> one-month duration). Asthma is defined by the ATS guidelines. \n\n Subjects must have a negative chest radiogram or Chest CT scan within 6 months. \n\n No active GERD symptoms (< 7 RSI score) & a stable dose of Proton Pump Inhibitor (4 weeks). \n\n Eligibility Criteria of Postnasal Drip without cough: \n\n Postnasal drip by rhinoscopy \n\n No cough by visual analog scale. \n\n Patients have to be 18 years old or older. \n\n ", - "exclusion_criteria": ": \n\n Subject ", - "brief_summary": "This study is being done to find out why some people with mucus dripping down the back of their throat have a nagging cough while others do not cough.", - "NCTID": "NCT00588627" - }, - { - "brief_title": "Inhalation Profiling of Idiopathic Pulmonary Fibrosis (IPF) Patients", - "phase": "Phase 1", - "drugs": "['Assessment of Idiopathic Pulmonary Fibrosis over a period of up to 6 months']", - "drugs_list": [ - "Assessment of Idiopathic Pulmonary Fibrosis over a period of up to 6 months" - ], - "diseases": "['Idiopathic Pulmonary Fibrosis']", - "diseases_list": [ - "Idiopathic Pulmonary Fibrosis" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n Males/females aged 40 years and over, at the time of signing the informed consent. \n\n A female patient is eligible to participate if she is of: Non child-bearing potential, where females are post-menopausal, defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milliinternational units per milliliter (MlU/mL) and estradiol < 40 picograms per mililiter (pg/mL) (<147 pmol/L) is confirmatory. Peri-menopausal or pre-menopausal, and have a negative pregnancy test as determined by serum or urine human chorionic gonadotropin (hCG) test, confirmed at screening, and then at each subsequent clinic visit before the CT scanning is conducted. \n\n BMI within the range 18 - 32 kilogram per meter^2 (kg/m^2) (inclusive). \n\n Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. \n\n Patients will have a diagnosis of IPF as determined by a responsible and experienced Respiratory physician and based on established criteria defined by the American Thoracic Society/European Respiratory Society: American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias. \n\n Patient's lung function measurements of Forced vital capacity (FVC) and Diffusing capacity of the Lung for Carbon Monoxide (DLCO) at screening must fall within the category below to be included in this study: FVC >=40 % predicted and DLCO >=30 % predicted. \n\n ", - "exclusion_criteria": ": \n\n Patients with a current Idiopathic Pulmonary Fibrosis (IPF) exacerbation. \n\n Patients with a known underlying cause of pulmonary fibrosis. \n\n Patients that have both IPF and Chronic obstructive pulmonary disease (COPD) that requires therapy with more than an intermittent bronchodilator or a long acting muscarinic antagonist, or where the Forced Expiratory Volume in One Second (FEV1)/ Forced vital capacity (FVC) ratio is <0.65. \n\n Patients with an upper or lower respiratory tract infection within four weeks of Visit 1. \n\n Patients with a recognised co-existing respiratory disorder other than usual interstitial pneumonia (UIP) (e.g. significant COPD, asthma, sarcoid, lung carcinoma) that in the opinion of the investigator would confound the study outcomes. \n\n Patients with poorly controlled left ventricular heart failure. \n\n Serious or uncontrolled medical, surgical or psychiatric disease that in the opinion of the investigator would compromise patient safety or confound the study data (e.g. congestive cardiac failure [CCF], asthma, angina, neurological disease, liver dysfunction and blood dyscrasia). \n\n Patients found to have clinically significant anaemia until adequately treated. \n\n Patients that have a history of alcohol abuse. \n\n Patients who are currently taking Pirfenidone for IPF or who have received Pirfenidone within the previous 30 days prior to Visit 1. \n\n Patients with previous exposure to ionising radiation > 5 millieSievert (mSv) in the 3 years prior to enrolment (not including ionising radiation used for therapeutic or diagnostic purposes or for purposes that involve patient benefit). \n\n Patients who have a history of claustrophobia. \n\n As a result of the medical history, physical examination or screening investigations, the physician responsible considers the patient unfit for the study. \n\n The patient is unable or unwilling to perform study assessments and procedures correctly. \n\n The patient has received an investigational drug for IPF within 30 days of the start of the study. \n\n A requirement for long-term oxygen therapy (LTOT) as defined by the prescription of oxygen to be used for greater than or equal to 12 hours of therapy per day. Note - short burst oxygen therapy is permitted. \n\n Patient is kept under regulatory or judicial order in an institution. \n\n Patient is mentally or legally incapacitated.", - "brief_summary": "This is a clinical study to characterise the lung function, airway morphometry, pharyngometry and inhalation profiles in patients with mild to severe Idiopathic Pulmonary Fibrosis (IPF) over a period of up to 6 months. Inhalation profiles will be recorded from patients with IPF as they inhale during tidal breathing, and following two sets of instructions (maximal effort and 'long, steady and deep' inhalation), across a range of airflow resistances that reflect those of typical inhalers used to deliver medication to the lungs. Mouth and throat dimensions will be measured using an acoustic reflectance Pharyngometer. Measurements of lung function will be made using conventional sprirometry, plethysmography and diffusion, whilst Low Dose High Resolution Computed Tomography (HRCT) will be used to scan the airways at two lung volumes; functional residual capacity (FRC) and total lung capacity (TLC). Data from HRCT will be used to reconstruct airway morphometry, and model inhaled particle deposition within the lung. Overall, the study allows a further understanding of the IPF patient population, using the data to assist in the development of new inhaled products for this disease. Following up the patients with additional HRCT scans at 3 and 6 months will enable the sensitivity of CT based criteria of disease progression to be compared with lung function criteria. No investigational product will be used in this study.", - "NCTID": "NCT02058602" - }, - { - "brief_title": "Determine the Association Between the Level of SCI With Chronic Respiratory Symptoms, Measures of Pulmonary Function, and Respiratory Illness.", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Spinal Cord Injuries']", - "diseases_list": [ - "Spinal Cord Injuries" - ], - "enrollment": "400.0", - "inclusion_criteria": "Spinal cord injury of >= 1 year in duration, and no other neuromuscular diseases", - "exclusion_criteria": "", - "brief_summary": "This study is using a standardized method to assess respiratory function in SCI in order to determine the association between level of SCI with chronic respiratory symptoms, measures of pulmonary function, and respiratory illness, both cross-sectionally and longitudinally.", - "NCTID": "NCT00011336" - }, - { - "brief_title": "Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.", - "phase": "", - "drugs": "['procedures']", - "drugs_list": [ - "procedures" - ], - "diseases": "['Nasopharyngeal Colonization and Acute Otitis Media']", - "diseases_list": [ - "Nasopharyngeal Colonization and Acute Otitis Media" - ], - "enrollment": "1320.0", - "inclusion_criteria": "inclusion criteria: \n\n Healthy Children: \n\n Male or female age greater than/equal to 6 months or less than/equal to 36 months old. \n\n Parent/guardian willing to bring to all study visits \n\n ", - "exclusion_criteria": ": \n\n Any major illness/condition that in investigator opinion would put subject at risk during study. \n\n Otorrhea or tympanostomy tubes present in either ear @ time of enrollment. \n\n Direct descendant of study site personnel. \n\n Subjects < 6 months old or >36 months old at the time of enrollment", - "brief_summary": "The purpose of this study is to Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.", - "NCTID": "NCT02591563" - } - ], - "1": [ - { - "brief_title": "Community Acquired Pneumonia in Telemark and Ostfold", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Community Acquired Pneumonia']", - "diseases_list": [ - "Community Acquired Pneumonia" - ], - "enrollment": "380.0", - "inclusion_criteria": "inclusion criteria: \n\n Symptoms of lower airway infection and radiologic sings of pneumonia. \n\n ", - "exclusion_criteria": ": \n\n Age<18 \n\n Serious psychiatric illness \n\n Mentally retarded \n\n Hospitalized last 14 days", - "brief_summary": "The aim of the study is to investigate the bacterial causes in community acquired pneumonia in adults admitted to hospital in two counties in Norway and to look at possible factors that makes the patients susceptible to pneumonia.", - "NCTID": "NCT00467701" - }, - { - "brief_title": "KEYS: Study Comparing Clinical Health Outcomes of Telithromycin Versus Azithromycin in Outpatients With Community-acquired Lower Respiratory Tract Infections", - "phase": "Phase 4", - "drugs": "['Telithromycin', 'Azithromycin']", - "drugs_list": [ - "Telithromycin", - "Azithromycin" - ], - "diseases": "['Respiratory Tract Infections', 'Chronic Bronchitis', 'Pneumonia']", - "diseases_list": [ - "Respiratory Tract Infections", - "Chronic Bronchitis", - "Pneumonia" - ], - "enrollment": "2051.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects meeting all of the following criteria will be considered for enrollment into the study: \n\n Male and female adult outpatient subjects diagnosed with AECB or CAP \n\n Female subjects must be either postmenopausal for \u2265 1 year or surgically incapable of bearing children. Women of childbearing potential must have a normal menstrual flow \u2264 1 month before study entry, a negative serum pregnancy test immediately prior to study entry, and meet the criteria for acceptable birth control. \n\n Informed consent must be obtained in writing for all subjects upon enrollment. \n\n Subjects will have a diagnosis of AECB or CAP, as defined below. \n\n AECB-Specific inclusion criteria: \n\n Subjects greater than or equal to 35 years of age \n\n Subjects with a documented history of chronic bronchitis: with a basal forced expiratory volume in one second (FEV1) < 70% and > 35%; who have had at least one or more AECB in the previous year; and with FEV1/forced vital capacity (FVC) < 70%. \n\n Subjects with a clinical diagnosis of AECB, presumed to be due to bacterial infection based on increased sputum purulence with either increased dyspnea or sputum volume \n\n Subjects producing spontaneous sputum \n\n Subjects with a \u2265 10 pack-year history of cigarette smoking \n\n CAP-Specific inclusion criteria: \n\n Fever (oral temperature > 38\u00b0C [100.4\u00b0F] or tympanic temperature > 38.5\u00b0C [101.2\u00b0F] or rectal temperature > 39\u00b0C [102.2\u00b0F]) \n\n Chills \n\n Pleuritic chest pain \n\n Cough \n\n Spontaneous production of purulent sputum or a change in sputum character \n\n Auscultatory findings (such as rales [also known as crepitations] and/or evidence of pulmonary consolidation [ie, dullness on percussion, bronchial breath sounds, egophony]) \n\n Subjects greater than or equal to 18 years of age \n\n Chest x-ray findings that support a clinical diagnosis of bacterial pneumonia (eg, presence of presumably new infiltrate[s]) \n\n Subjects with a clinical diagnosis of mild to moderate CAP due to bacterial infection based on at least 1 of the following signs and symptoms of CAP: \n\n In addition, subjects with a clinical diagnosis of CAP will have at least 1 of the following signs and symptoms of CAP: \n\n Dyspnea or tachypnea (particularly if progressive in nature) \n\n ", - "exclusion_criteria": ": \n\n Subjects presenting with any of the following will not be included in the study: \n\n Subjects with a known history of congenital long-QTc syndrome \n\n Subjects who are pregnant or breast-feeding \n\n Subjects who have hypersensitivity to telithromycin, azithromycin, or the macrolide classes of antibiotics \n\n Subjects who require or receive treatment with rifampin (Rifadin), phenytoin (Dilantin), carbamazepine (Carbatrol, Tegretol), phenobarbital, or St. John's wort (herbal supplement) within 2 weeks prior to Visit 1 or during the study \n\n Subjects who require treatment during the study with ergot alkaloid derivatives, cisapride (Propulsid), pimozide (Orap), bromocriptine, cabergoline (Dostinex), or pergolide (Permax) \n\n Subjects who have previously participated in this study \n\n Subjects with a previous history of myasthenia gravis \n\n Subjects with current acute respiratory failure or subjects who require aggressive airway management \n\n Hospitalized subjects and subjects from institutional care facilities \n\n Subjects who have been treated with oral or parenteral antibiotics within 14 days prior to enrollment or who plan to take antibiotics other than study drug during the treatment period \n\n Subjects who are receiving other medications, including systemic antimicrobial agents, or who have other disease conditions or infections that could interfere with the evaluation of drug efficacy or safety \n\n Subjects with a concomitant condition (including clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease) that makes either implementation of the protocol or interpretation of the study results difficult \n\n Subjects with a progressively fatal disease or life expectancy of < 3 months \n\n Subjects who have received any other investigational drug or device within 1 month prior to study entry, or who have such treatment planned during the study period \n\n Subjects with a recent (within 3 months) history of drug or alcohol abuse \n\n Immunocompromised subjects, including but not limited to subjects with: known human immunodeficiency virus infection (CD4 count < 200/mm3); known neutropenia (< 1500 neutrophils/mm3); chronic corticosteroid therapy (\u2265 10 mg/day prednisolone therapy or equivalent for at least the past 3 months); immunosuppressant treatment, other than corticosteroids, within the previous 6 months; splenectomized subjects or subjects with known hyposplenia or asplenia. \n\n Subjects with mental conditions that render them unable to understand the nature, scope, and possible consequences of the study \n\n Subjects who are unlikely to comply with the protocol (eg, have an uncooperative attitude, an inability to return for follow-up visits, or are unlikely to complete the study) \n\n Subjects who have known impaired hepatic function \n\n Subjects who have known impaired renal function \n\n AECB-Specific ", - "brief_summary": "The purpose of this study is to determine if 1 course of antibiotic treatment with telithromycin is superior to azithromycin in the treatment of lower respiratory tract infections (LRTIs), acute exacerbations of chronic bronchitis (AECBs) and community-acquired pneumonia (CAP) in the community setting.", - "NCTID": "NCT00132951" - }, - { - "brief_title": "An Open-label, Randomized, and Comparative Study to Evaluate the Efficacy and Safety of Cefoperazone/Sulbactam in Comparison to Cefepime for the Treatment of Hospital-acquired Pneumonia and Healthcare-associated Pneumonia", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pneumonia']", - "diseases_list": [ - "Pneumonia" - ], - "enrollment": "142.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female patients aged \u226718 years old \n\n Patients with nosocomial bacterial pneumonia at least 48 hours after hospitalization or patients with healthcare-associated pneumonia(HCAP*). \n\n Clinical findings \n\n At least two of the following signs: \n\n Cough \n\n Fever: axillary temperature > 37.5\u2103 or tympanic temperature > 38.5\u2103 \n\n Hypothermia: axillary temperature < 34\u2103 or tympanic temperature < 35\u2103 \n\n Purulent sputum production or respiratory secretion \n\n Total peripheral white blood cell (WBC) count > 10,000/mm3; or > 15% band forms, regardless of total peripheral white count; or leucopenia with total WBC < 4500/mm3 \n\n Auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony) \n\n Hypoxemia (defined as a partial O2 pressure <60 mmHg while the patient was breathing normal air or a decrease in the partial O2 pressure of \u226725% from an initial value) \n\n Radiographic findings The chest radiograph should show the presence of a new or progressive infiltration on the chest X-ray film \n\n Microbiologic criteria If sputum specimen is available and collected, both tests are mandatory with at least one of the following results is positive: \n\n (1) Within 24 hours prior to, or at the time of enrollment, all patients should have had a culture and susceptibility testing of respiratory secretions or sputum to study drugs (2)Gram stain of respiratory secretions or sputum \n\n Patient must be able to sign a written informed consent form prior to the start of the study procedures. If any patient is unable to give consent, it must be obtained from the patient's legal representative \n\n Subject has not received more than 24 hours of a parenteral antibacterial drug for the current pneumonia. If subject has received more than 24 hours of a parenteral antibacterial drug, he/she must be declared as treatment failure. \n\n ", - "exclusion_criteria": ": \n\n Woman who are pregnant (determined by urine test) or lactating state \n\n Patients with known bronchial obstruction or a history of postobstructive pneumonia. (This does not exclude patients who have chronic obstructive pulmonary disease) \n\n A neutrophil count <1000/mm3 \n\n Patients with pneumonia due to viral, fungal, or mycobacterial infection. \n\n Patients who were known to have been infected with human immunodeficiency virus \n\n Documented Legionella pneumonia \n\n Patients were infected with gram negative (G-) microorganism known to be resistant to one of the study antibiotics during trial \n\n Subjects with sputum gram stain of PMN>25, epithelial cell <10, and gram positive (G+) cocci in cluster predominant and phagocytosis \n\n Patients who have received any other investigational drug within 30 days prior to enrollment \n\n Patients who have received medications like cefoperazone, cefoperazone/sulbactam and cefepime within 30 days prior to enrollment \n\n Patients with abnormal pre-therapy laboratory data: aspartate aminotransferase (AST), alanine aminotransferase (ALT) \u2267 3X ULN (upper limit of normal); or serum creatinine, urea nitrogen > 3X ULN \n\n A history of hypersensitivity to penicillins, cephalosporins, carbapenems or J-lactam/J-lactamase inhibitors \n\n Severe disease (eg. septic shock, acute respiratory distress syndrome, and multiple organ failure) which may limit survival during therapy and follow-up period, or confound the results of the study as judged by the investigator", - "brief_summary": "This is a phase III, multi-center, open-label, comparative and randomized study in evaluating the efficacy and safety of cefoperazone/sulbactam versus cefepime for the treatment of hospital-acquired pneumonia and healthcare-associated pneumonia. The investigator will determine the total duration of study therapy, as clinically indicated. The minimum duration of study therapy will be 7 days and the maximum allowable duration of study therapy will be 21 days.", - "NCTID": "NCT01280461" - }, - { - "brief_title": "Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia", - "phase": "Phase 3", - "drugs": "['lefamulin', 'Moxifloxacin', 'Linezolid']", - "drugs_list": [ - "lefamulin", - "Moxifloxacin", - "Linezolid" - ], - "diseases": "['Community Acquired Pneumonia']", - "diseases_list": [ - "Community Acquired Pneumonia" - ], - "enrollment": "551.0", - "inclusion_criteria": "inclusion criteria: \n\n Be male or female at least 18 years of age. \n\n Provide written informed consent and be willing and able to adhere to the study-specified procedures and restrictions. \n\n Have an acute illness (7 days duration) with at least 3 of the following symptoms consistent with a lower respiratory tract infection (new or worsening): \n\n Dyspnea \n\n New or increased cough \n\n Purulent sputum production \n\n Chest pain due to pneumonia \n\n Have at least 2 of the following vital sign abnormalities: \n\n Fever (body temperature >38.0\u00b0C (100.4\u00b0F) measured orally or equivalent temperature from an alternate body site) or hypothermia (body temperature <35.0\u00b0C (95.0\u00b0F) measured orally or equivalent temperature from an alternate body site) \n\n Hypotension (systolic blood pressure <90 mmHg) \n\n Tachycardia (heart rate >100 beats/min) \n\n Tachypnea (respiratory rate >20 breaths/min) \n\n Have at least 1 other clinical sign or laboratory finding of CABP: \n\n Hypoxemia (i.e., O2 saturation <90% on room air or while receiving supplemental oxygen at subject's baseline requirement or PaO2 <60 mmHg) \n\n Auscultatory and/or percussion findings consistent with pneumonia (e.g., crackles, egophony, dullness) \n\n White blood cell (WBC) count >10,000 cells/mm3 or <4500 cells/mm3 or >15% immature neutrophils (bands) regardless of total WBC count \n\n Have radiographically-documented pneumonia within 48 hours before enrollment (i.e., infiltrates in a lobar or multilobar distribution or diffuse opacities on chest x-ray or chest computed tomography scan consistent with acute bacterial pneumonia). \n\n Have a Pneumonia Outcomes Research Team (PORT) Risk Class \u2265III. \n\n ", - "exclusion_criteria": ": \n\n Have received more than a single dose of a short-acting oral or IV antibacterial for CABP within 72 hours before randomization \n\n Require concomitant systemic antibacterial therapy potentially effective against CABP pathogens \n\n Have been hospitalized for 2 or more days within 90 days prior to the onset of symptoms or have resided in a nursing home or long-term healthcare facility within 30 days prior to the onset of symptoms. NOTE: Residence in an independent living facility is permitted. \n\n Have confirmed or suspected CABP caused by a pathogen known to be resistant to any of the study drugs (e.g., Pseudomonas aeruginosa, any pathogen of the Enterobacteriaceae Family) or attributable to etiologies other than community acquired bacterial pathogens (e.g., ventilator associated pneumonia, hospital acquired bacterial pneumonia, bacterial aspiration pneumonia, Pneumocystis jiroveci pneumonia or other fungal pneumonia, viral or mycobacterial infection of the lung). \n\n Have a noninfectious cause of pulmonary infiltrates (e.g., pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure, bronchial obstruction, lung cancer, cystic fibrosis). \n\n Have confirmed or suspected pleural empyema (does not include sterile parapneumonic effusions). \n\n Require mechanical ventilation.", - "brief_summary": "This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate to severe community-acquired bacterial pneumonia.", - "NCTID": "NCT02559310" - }, - { - "brief_title": "Nebulized Colistin for Hospital-Acquired Pneumonia", - "phase": "Phase 3", - "drugs": "['nebulized colistin', 'antibiotics']", - "drugs_list": [ - "nebulized colistin", - "antibiotics" - ], - "diseases": "['Pneumonia']", - "diseases_list": [ - "Pneumonia" - ], - "enrollment": "140.0", - "inclusion_criteria": "inclusion criteria: \n\n Adult (age>18 years) hospitalized patient with hospital-acquired pneumonia due to Gram negative bacteria \n\n ", - "exclusion_criteria": ": \n\n pregnancy \n\n lactating woman \n\n colistin allergy \n\n severe renal impairment \n\n epilepsy", - "brief_summary": "Nebulized Colistin for Adjunctive Therapy of Hospital-Acquired Pneumonia caused by Gram Negative Bacteria should be more effective than conventional therapy", - "NCTID": "NCT00920270" - }, - { - "brief_title": "Study of Cidecin\u2122 (Daptomycin) to Rocephin\u00ae (Ceftriaxone) in the Treatment of Moderate to Severe Community-Acquired Acute Bacterial Pneumonia Due to S. Pneumoniae", - "phase": "Phase 3", - "drugs": "['daptomycin']", - "drugs_list": [ - "daptomycin" - ], - "diseases": "['Pneumonia, Bacterial']", - "diseases_list": [ - "Pneumonia", - "Bacterial" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Provide signed and dated informed consent. \n\n Adults, 18 years of age or older of either gender and of any race weighing up to 150 kg. Female patients of childbearing potential MUST be nonpregnant (confirmed by negative serum pregnancy test), nonlactating, and must be willing to practice reliable birth control measures during and for at least 30 days after treatment with study drug(s). \n\n Have a new pulmonary infiltrate on chest radiograph. \n\n Exhibit at least two of the following clinical symptoms of pneumonia on history or physical: \n\n Cough \n\n Production of purulent sputum or change in character of sputum \n\n Auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation (dullness to percussion, bronchial breath sounds, or egophony) \n\n Dyspnea or tachypnea \n\n Documented fever, defined as body temperature >38.0 \u00baC (100.4 \u00baF) taken orally; >38.5 \u00baC (101.2 \u00baF) tympanically; or >39.0 \u00baC (102.2 \u00baF) rectally or hypothermia, defined as core body temperature of <35.0 \u00baC (95.0 \u00baF) \n\n An elevated total peripheral white blood cell count (WBC >10,000/mm3); or >15% immature neutrophils (bands), regardless of total peripheral white count; or leukopenia with total WBC <4500/mm3. \n\n Hypoxemia with a PO2 < 60 mmHg (on room air) or O2 saturation <90% on room air \n\n Pneumonia which requires hospitalization and intravenous therapy for at least 5 days. \n\n Willingness to participate in this study and to complete all follow-up assessments. \n\n ", - "exclusion_criteria": ": \n\n Patients with Grade V pneumonia (based on Fine Score; Attachment 8). \n\n Patients in respiratory failure or incipient respiratory failure if the patient is not a candidate for mechanical ventilation (for any reason). \n\n Any of the following pulmonary conditions that may preclude interpretation of study results: \n\n Cystic fibrosis \n\n Primary lung cancer or another malignancy metastatic to the lungs \n\n Known bronchial obstruction or a history of post-obstructive pneumonia \n\n Known or suspected active tuberculosis. \n\n Severe shock (systolic blood pressure <90 mm Hg for >30 minutes not corrected by fluid bolus). \n\n Clinical evidence of bacterial meningitis (based on lumbar puncture results). \n\n Severe renal impairment (calculated creatinine clearance <30 mL/min). \n\n Moribund clinical condition: high likelihood of death during the first 48 hours. \n\n If HIV positive, known CD4 counts <200/mm3 or evidence of Pneumocystis carinii pneumonia. \n\n Inability to tolerate ceftriaxone or history of allergy to beta-lactam antibiotics (history of rash alone will not exclude a patient). \n\n Any individual previously treated with a potentially effective anti-infective agent for > 24 hours (or one dosing day) within 72 hours of enrollment, or prior treatment with any investigational drug (including experimental biologic agents) in previous 30 days or prior therapy with daptomycin. \n\n Patients who must continue HMG-CoA reductase inhibitor therapy (e.g., simvastatin, lovastatin, etc.) during the study treatment period. \n\n Anticipation that a second non-protocol systemic antibiotic will be required. \n\n Induction chemotherapy within 2 weeks prior to enrollment (or exogenous therapies which are anticipated to result in PMN counts of <200 mm3 during Treatment Phase), or patients with severe neutropenia (<200 PMN cells/mm3). \n\n Patients considered unreliable to return for visits or to comply with study procedures. \n\n Progressive neoplastic disease (Note: patients with malignancies in remission are eligible). \n\n Women who are pregnant or nursing/lactating. \n\n Patients presenting with nosocomial pneumonia (i.e., <14 days after discharge from a skilled nursing facility or hospital with an initial hospitalization of >=3 days duration). \n\n Clinical suspicion of Legionella pneumonia.", - "brief_summary": "A COMPARASON OF CIDECIN\u2122 (DAPTOMYCIN) TO ROCEPHIN\u00ae (CEFTRIAXONE) IN THE TREATMENT OF MODERATE TO SEVERE COMMUNITY-ACQUIRED ACUTE BACTERIAL PNEUMONIA DUE TO S. PNEUMONIAE", - "NCTID": "NCT00540072" - }, - { - "brief_title": "Suitability of Antibiotic Treatment for CAP", - "phase": "", - "drugs": "['Intervention group', 'Control group']", - "drugs_list": [ - "Intervention group", - "Control group" - ], - "diseases": "['Community Acquired Pneumonia']", - "diseases_list": [ - "Community Acquired Pneumonia" - ], - "enrollment": "602.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 or older, \n\n admitted with CAP will be included sequentially. Pneumonia is defined as pulmonary infiltrate shown in a thoracic X-ray not known to be old, \n\n ", - "exclusion_criteria": ": \n\n patients with human immunodeficiency virus infection, \n\n immunosupressed patients (with a solid organ transplant, spelenectomy, treated with a prednisone dose of 10 mg/day or equivalent for longer than 30 days or with other immunodepressors, with neutropenia), \n\n those hospitalized in the 14 days prior and those living in assisted care facilities. \n\n pneumonia cases caused by infrequent agents (i.e. P. aerouginosa, S. Aureus) will also be excluded, as well as infectious processes requiring an extended treatment with antibiotocs (i.e. bacterial endocarditis, abscesses), \n\n pneumonia cases with pleural effusion requiring a drainage tube, \n\n patients who were deceased or admitted to ICU before randomization and those not giving their informed consent.", - "brief_summary": "The duration of antibiotic treatment in community-acquired pneumonia (CAP) lasts about 9-10 days, and is determined empirically. The last North American guideline for CAP recommends using clinical stability criteria as a reference to establish the duration of antibiotic treatment, which would result in about 5 days of antibiotic use for the majority of pneumonia cases. In order to validate this proposal we propose to carry out a randomized multicenter double-blind (until the 5th day) clinical trial with adult CAP patients admitted to 4 hospitals in Euskadi. A control group (with routine treatment) will be compared with an intervention group (antibiotic treatment for at least 5 days, which will be interrupted if temperature is =< 37,8\u00baC for at least 48 hours and no more than one sign of clinical instability is assessed), with regards to: mortality at 15 days, clinical recovery by days 10 and 30, clinical improvement after days 5 and 10 as evaluated by PRO scales, duration of antibiotic treatment. A non-inferiority dichotomous sequential analysis will be performed (for mortality after 15 days, clinical recovery by day 10 and in follow-up at 30 days, clinical improvement after days 5 and 10, with PRO scales) as well as a superiority analysis for the duration of the antibiotic treatment. A total of 1100 patients will be recruited, following their signed consent, during the inclusion period (18 months). Stability criteria will be measured daily. The rest of the variables will be measured at admission and by telephone on days 10 and 30.", - "NCTID": "NCT01661920" - }, - { - "brief_title": "Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP", - "phase": "", - "drugs": "['Point-of-Care diagnostic laboratory test']", - "drugs_list": [ - "Point-of-Care diagnostic laboratory test" - ], - "diseases": "['Community-acquired Pneumonia']", - "diseases_list": [ - "Community-acquired Pneumonia" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n \u25cf Adult patients greater than age 17 years who are initially evaluated in the ED with symptoms of CAP. This includes those who will be treated as outpatients and those admitted to the hospital (both ward and ICU). \n\n The definition of CAP is as follows: \n\n Presence of pulmonary infiltrates on chest radiography. (Initial reading may be performed by the ED physician - but has to be confirmed by board certified radiologist for inclusion in the study). \n\n At least 2 of the following: new onset of cough, productive sputum, shortness of breath, chest pain, fever > 380C, abnormal chest auscultation, WBC > 12,000 cells/mL. \n\n Able to provide informed consent \n\n Read, signed, and dated informed consent document \n\n Available for follow-up for the planned duration of the study \n\n ", - "exclusion_criteria": ": \n\n Patients with underlying immunosuppressive illness (HIV, neutropenia, asplenia, transplant recipient, cystic fibrosis, receipt of immunosuppressive medications including corticosteroids, (equivalent of prednisone > 10 mg) cancer chemotherapy, or anti-tumor necrosis factor agents. \n\n Patients residing in long-term care facilities", - "brief_summary": "This is a prospective interventional study to assess laboratory testing which will identify the microbial cause of pneumonia. This, in turn, will allow targeted antimicrobial agent selection for patients with community acquired-pneumonia (CAP).~Hypothesis: 1) To determine if Targeted strategy is non-inferior to Empiric therapy with respect to outcome endpoints. 2) To assess the use of innovative POC tests allows targeted narrow-spectrum antimicrobial therapy. 3) To determine if Targeted strategy is superior to Empiric therapy in patients with viral pneumonia", - "NCTID": "NCT01662258" - }, - { - "brief_title": "Does Azithromycin Cause QT Prolongation in Hospitalized Patients With Severe Community Acquired Pneumonia?", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pneumonia']", - "diseases_list": [ - "Pneumonia" - ], - "enrollment": "148.0", - "inclusion_criteria": "inclusion criteria: \n\n Severe community acquired pneumonia \n\n treated with azithromycin \n\n age over 18 years \n\n ", - "exclusion_criteria": ": \n\n Azithromycin initiated before hospitalization \n\n technically undecipherable ECG \n\n Permanent pacemaker", - "brief_summary": "The macrolide group of antibiotics can cause QT prolongation, and endanger the patient with life threatening arrythmias. QT prolongation caused by Azythromycin, a relatively new macrolide, is extremely rare, and was not reported in clinical trials. Our hypothesis is that patients hospitalized with severe community acquired pneumonia, usually with multiple comorbid conditions will have a higher rate of QT prolongation, compared to the clinical trials published", - "NCTID": "NCT01553734" - }, - { - "brief_title": "Procalcitonin Level and Kinetics in Children With Bacterial Infections", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Bacterial Infections', 'Bacteremia', 'Meningitis', 'Urinary Tract Infection', 'Mastoiditis', 'Lobar Pneumonia', 'Septic Arthritis', 'Cellulitis', 'Osteomyelitis']", - "diseases_list": [ - "Bacterial Infections", - "Bacteremia", - "Meningitis", - "Urinary Tract Infection", - "Mastoiditis", - "Lobar Pneumonia", - "Septic Arthritis", - "Cellulitis", - "Osteomyelitis" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Positive blood, urine, synovial, bone, pleural effusion, abscess or CSF culture \n\n Cellulitis, lobar pneumonia, osteomyelitis,", - "exclusion_criteria": "", - "brief_summary": "The purposes of this study are:~To determine whether procalcitonin level at admission of pediatric patients with bacterial infections can be used as a marker for prediction of defervescence and hospitalization length~To examine the kinetics of procalcitonin in pediatric patients with bacterial infections and persistent fever", - "NCTID": "NCT00714402" - } - ], - "2": [ - { - "brief_title": "Epidemiology of Community Acquired Pneumonia in North Israel", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Community Acquired Pneumonia']", - "diseases_list": [ - "Community Acquired Pneumonia" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Community acquired pneumonia \n\n Hospitalization \n\n ", - "exclusion_criteria": ": \n\n Immunocompromised patients \n\n Patients under chemotherapy treatment \n\n Patients under steroids treament", - "brief_summary": "Pneumonia in general and CAP in particular is considered as one of the most common bacterial infections, associated with high rates of morbidity and mortality and is highly significant economically since all respiratory infections, and pneumonia especially, cause about 80% of antimicrobials use in the community. The high frequency of respiratory infections and the excessive use of antimicrobials are major contributors to the development of pathogens resistant to antimicrobials. In addition, in CAP almost all patients are treated empirically, without identification of causing pathogen.~Aim of study: To identify common pathogens causing CAP in hospitalized patients in north Israel.", - "NCTID": "NCT00390819" - }, - { - "brief_title": "Usefulness of Microbiological Tests in Community-Acquired Pneumonia", - "phase": "", - "drugs": "['empirical versus microbiological guided treatment']", - "drugs_list": [ - "empirical versus microbiological guided treatment" - ], - "diseases": "['Community-Acquired Pneumonia']", - "diseases_list": [ - "Community-Acquired Pneumonia" - ], - "enrollment": "250.0", - "inclusion_criteria": "inclusion criteria: \n\n Age: 18 years and above \n\n Clinical and radiological diagnosis of community-acquired pneumonia \n\n Informed consent of patient \n\n Hospital admission \n\n ", - "exclusion_criteria": ": \n\n Prior hospital admission (less than 15 days) \n\n Alternative diagnosis at the discharge \n\n Immunosuppression (HIV infection, immunosuppressive therapies, neutropenia) \n\n Risk factors for unusual etiologies \n\n Patient is pregnant", - "brief_summary": "The hypothesis is that community-acquired pneumonia is usually a monomicrobial infection. Therefore, early detection of the etiology allows to select the most active, narrow-spectrum, and cheap, and less toxic antibiotic agent.", - "NCTID": "NCT00312741" - }, - { - "brief_title": "A Safety and Efficacy Study of Hospitalized Patients With Community-Acquired Pneumonia and Sepsis", - "phase": "Phase 2", - "drugs": "['Recombinant Chimeric Monoclonal Antibody']", - "drugs_list": [ - "Recombinant Chimeric Monoclonal Antibody" - ], - "diseases": "['Pneumonia', 'Sepsis']", - "diseases_list": [ - "Pneumonia", - "Sepsis" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Current diagnosis of community-acquired pneumonia. \n\n Evidence of systemic inflammatory response to infection. \n\n ", - "exclusion_criteria": ": \n\n Atypical or viral pneumonia based on clinical or epidemiologic suspicion by the investigator. \n\n Presence of organ failure.", - "brief_summary": "The objective of this study is to demonstrate the safety and efficacy of IC14 in the treatment of hospitalized patients with community-acquired pneumonia and sepsis.", - "NCTID": "NCT00042588" - }, - { - "brief_title": "A Clinical Pathway for Nursing Home Acquired Pneumonia", - "phase": "", - "drugs": "['a clinical pathway nursing home acquired pneumonia']", - "drugs_list": [ - "a clinical pathway nursing home acquired pneumonia" - ], - "diseases": "['Pneumonia', 'Lower Respiratory Tract Infection']", - "diseases_list": [ - "Pneumonia", - "Lower Respiratory Tract Infection" - ], - "enrollment": "680.0", - "inclusion_criteria": "inclusion criteria: \n\n Symptoms or signs of lower respiratory tract infection as defined by standardized criteria. \n\n ", - "exclusion_criteria": ": \n\n Residents were excluded if they were not expected to live longer than 30 days from the date of enrollment, had a previous anaphylactic or serious allergic reaction to quinolones, had advanced directives that they are not be transferred to hospital for treatment.", - "brief_summary": "Nursing home residents are frequently transferred to hospital for management of pneumonia. This often leads to hospital related complications and is a burden on the acute care health system. The purpose of this study is to assess whether managing residents with pneumonia and lower respiratory tract infection on site in the nursing home can reduce hospital admissions and can reduce complications and improve quality of life for residents. We have randomized residents with nursing home acquired pneumonia to on-site management, using a clinical pathway, versus usual care.", - "NCTID": "NCT00157612" - }, - { - "brief_title": "Sleep Apnea Syndrome and Community Acquired Pneumonia", - "phase": "", - "drugs": "['abbreviated polysomnography']", - "drugs_list": [ - "abbreviated polysomnography" - ], - "diseases": "['Sleep Apnea Syndrome', 'Polygraphy', 'Community Acquired Pneumonia', 'Infections']", - "diseases_list": [ - "Sleep Apnea Syndrome", - "Polygraphy", - "Community Acquired Pneumonia", - "Infections" - ], - "enrollment": "123.0", - "inclusion_criteria": "Group A: \n\n inclusion criteria: \n\n Hospital admission and Community acquired pneumonia \n\n ", - "exclusion_criteria": ": \n\n Nosocomial infections \n\n Low level of conscientiousness \n\n Neurological disease \n\n Impossibility to complete the questionnaires \n\n Group B \n\n inclusion criteria: \n\n Hospital admission and other infections different to respiratory infections", - "brief_summary": "The association of sleep apnea-hypopnea syndrome (SAHS) with the infections of the lower airway has not been studied. The aspiration of secretions of the upper airway and the colonization by microorganisms is considered a main event in most of the cases of community acquired pneumonia (CAP) , and specially in the nosocomial pneumonia. The silent aspiration to the lower airway is a common phenomenon in normal subjects during the sleep and some studies has reported that the patients with SAHS present an increase of the risk to pharyngeal aspirations. In fact, the presence of nasal and bronchial inflammation in patients with SAHS is a recognized event. The patients with SAHS could have a risk increased to develop pneumonia due to predisposition to the pharyngeal microaspiration to lower airways during the sleep and other mechanical factors associated. The prevalence of SAHS in patients with CAP could be increased as regards the data published for the same Spanish population. The presence of an apnea-hypopnea index (AHI) could be a risk factor not only to to CAP but to to present a unfavorable clinical evolution in comparison to patients with CAP with a normal AHI. The aim of this study will establish a relation between SAHS and the pneumonia risk.", - "NCTID": "NCT01071421" - }, - { - "brief_title": "Clinical Indicators of Radiographic Findings in Patients With Suspected Community-Acquired Pneumonia", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pneumonia']", - "diseases_list": [ - "Pneumonia" - ], - "enrollment": "350.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years of age or older \n\n acute respiratory symptoms \n\n positive chest radiographs \n\n patients from outpatient clinics and the emergency department \n\n ", - "exclusion_criteria": ": \n\n under the age of 18 \n\n suspected hospital-acquired pneumonia (positive radiographs within 10 days of hospital discharge) \n\n suspected aspiration pneumonia", - "brief_summary": "This is a study involving the emergency department and outpatient clinics of the David Grant United States Air Force (USAF) Medical Center, a tertiary care facility. Patients 18 years of age or older with acute respiratory symptoms and positive or equivocal chest radiographs from October 1, 2004 through May 31, 2005 will be included as positive cases. Controls will be randomly selected from a review of negative chest radiograph reports with a clinical history of an acute respiratory illness over the same time period. Once patients are appropriately identified as control or cases, outpatient charts will be reviewed to gather data on six clinical indicators. Sensitivities and specificities will be calculated for each clinical indicator, to determine which patients require chest radiographs in the setting of suspected community acquired pneumonia (CAP)", - "NCTID": "NCT00118651" - }, - { - "brief_title": "A Retrospective Study on Hospitalized Patients With Community-acquired Pneumonia in China (CAP-China)", - "phase": "", - "drugs": "['other']", - "drugs_list": [ - "other" - ], - "diseases": "['Community Acquired Pneumonia']", - "diseases_list": [ - "Community Acquired Pneumonia" - ], - "enrollment": "3000.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients > or = 14 years of age \n\n Patient meets the criteria of community acquired pneumonia \n\n Patient meets the criteria of healthcare-associated pneumonia \n\n ", - "exclusion_criteria": ": \n\n Patients <14 years of age \n\n Patient meets the criteria of hospital acquired pneumonia \n\n Known active tuberculosis or current treatment for tuberculosis \n\n Non-infectious pulmonary diseases \n\n HIV positive", - "brief_summary": "The purpose of this study is to evaluate the disease burden of hospitalized patients with CAP and healthcare-associated pneumonia (HCAP) in real life of China .", - "NCTID": "NCT02489578" - }, - { - "brief_title": "Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)", - "phase": "", - "drugs": "['clarithromycin modified release 500 mg']", - "drugs_list": [ - "clarithromycin modified release 500 mg" - ], - "diseases": "['Respiratory Tract Infection']", - "diseases_list": [ - "Respiratory Tract Infection" - ], - "enrollment": "335.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults, equal to or more than 18 years years of age \n\n Patients with respiratory tract infections, including any of the following: \n\n Acute tracheitis, acute tracheobronchitis \n\n Acute sinusitis \n\n Chronic sinusitis \n\n Acute tonsillopharyngitis \n\n Acute bronchitis \n\n Mild community-acquired pneumonia \n\n Acute exacerbation of chronic bronchitis \n\n ", - "exclusion_criteria": ": \n\n Known hypersensitivity to or previously intolerant of macrolides. \n\n Illness severe enough to warrant hospitalization or parenteral therapy. \n\n Concomitant use of any of the following medications: \n\n Drugs metabolized by CYP3A isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine. \n\n Drugs metabolized by other isozymes within CYP450 system: phenytoin, theophylline and valproate. \n\n Colchicine, Digoxin, Some antiretrovirals: zidovudine and ritonavir. \n\n Severe immunodeficiency and chronic disease conditions. \n\n Renal or hepatic impairment (creatinine clearance under 30 mL/min, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyltransferase (GGT) equal or more than 3x higher level in comparison with the norm). \n\n Mental condition rendering the subject unable to understand the nature of the study.", - "brief_summary": "The objective is to describe the time to recovery of symptoms (cough, mucus, fever, sore throat, and others), tolerability and compliance of treatment with clarithromycin once daily in patients with upper or lower respiratory tract infections in the routine clinical practice.", - "NCTID": "NCT01075204" - }, - { - "brief_title": "Microbiology and Clinical Outcome of Pneumonia", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Pneumonia']", - "diseases_list": [ - "Pneumonia" - ], - "enrollment": "2600.0", - "inclusion_criteria": "inclusion criteria: \n\n CAP criteria: \n\n Those pneumonia patients have not been admitted within 14 days before diagnosing pneumonia. \n\n Those pneumonia patients are not met the criteria of HCAP criteria as stated below. \n\n HCAP criteria: \n\n Regular hemodialysis, peritoneal dialysis or infusion therapy (ex TPN, repeated blood transfusion etc ) at a hospital or hemodialysis clinic. \n\n Receive radiation therapy or chemotherapy at out-patient clinics within 90 days \n\n to be admitted to an acute care hospital for two or more days within 90 days before the onset of pneumonia \n\n Resided in a nursing home or long-term care \n\n ", - "exclusion_criteria": ": \n\n The patients with HAP: pneumonia developed two days after admission or within 14 days after discharge (except RCW) \n\n VAP: HAP and with mechanical ventilation for at least 48h (except RCW patients) \n\n HIV positive with a CD4+ < 200", - "brief_summary": "BACKGROUND~Pneumonia occurring outside of the hospital setting is regarded as community acquired pneumonia. However, pneumonia occurring in non-hospital long-term care facilities constituted a distinct type of pneumonia from CAP. Kollef et al has justified health care associated pneumonia (HCAP) as a new category of pneumonia [1]. The HCAP patients are associated with severe disease, higher mortality rate, and greater length of stay and increased cost [1]. HCAP are often at risk for multi-drug resistant bacterial pathogens such as Pseudomonas aeruginosa, extended-spectrum beta-lactamase Klebsiella pneumoniae, Acinetobacter baumannii, and methicillin-resistant S. aureus (MRSA) [2].~Health care facilities have not been defined in Taiwan. Respiratory care ward (RCW) is a special unit to take care long-term ventilatory dependent patients in Taiwan. Some of the patients get pneumonia and are referred back to medical centers. Besides, community-acquired P. aeruginosa, Acinetobacter baumannii or MRSA have been reported [3-8]. Therefore, the core-organisms of HCAP in Taiwan might be multi-drug resistant and the causes of inadequate initial antibiotics treatment. The common pathogens were also unknown.~Till now, there are no data about the pathogens of HCAP in Taiwan. We define the health-care facilities and initiate a retrospective study to characterize the microbiology and clinical outcome of Community acquired pneumonia and Health-Care-Associated pneumonia in Taiwan. Further analysis will perform to confirm the differences between CAP an HCAP in Taiwan.~Objectives:~I. To characterize CAP and HCAP i. Microbiological epidemiology ii. Disease severity: PSI iii. Outcome : length of stay, mortality , antimicrobial susceptibility and treatment outcomes II. To characterize HCAP from RCW i. Microbiological epidemiology ii. Disease severity: PSI iii. Outcome : length of stay, mortality~Study design:~This is a retrospective multi-center cohort study to characterize microbiology, and clinical outcomes in Taiwan.~Data sources: CAP or HCAP registered in 4 medical centers from Jan 1 2007 to Dec. 31 2007. (2 in north Taiwan, 1 in central Taiwan, 1 in south Taiwan) Expected case number: 800 HCAP and 1800 CAP", - "NCTID": "NCT00873522" - }, - { - "brief_title": "A Polymerase Chain Reaction (PCR) - Based Method to Improve Antibiotic Prescribing for Pneumonia", - "phase": "", - "drugs": "['nasopharyngeal swab']", - "drugs_list": [ - "nasopharyngeal swab" - ], - "diseases": "['Pneumonia']", - "diseases_list": [ - "Pneumonia" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n presumed community-acquired pneumonia as diagnosed by the attending emergency department physician \n\n ", - "exclusion_criteria": ": \n\n age > 6 months \n\n immunodeficiency (primary, advanced HIV) \n\n cystic fibrosis \n\n malignancy \n\n known cardiac or lung defects \n\n bronchiectasis \n\n previous pneumonia or lung abscess in past 6 months \n\n conditions requiring treatment with immune suppressants", - "brief_summary": "Pneumonia, or lung infection, is usually treated with antibiotics targeted against the organisms that the physician guesses are causing the problem. The determination of the exact cause of a patient's pneumonia is difficult. The problem is that the two major causes of community-acquired pneumonia are not easily distinguished on clinical grounds and are best treated by different antibiotics. The investigators hypothesize that antibiotic therapy can be targeted and improved by doing polymerase chain reaction (PCR) testing of nose swabs to identify probable implicated organisms and their antibiotic resistance patterns. This pilot study will be important to ensure that the laboratory testing is functional and that the emergency department-laboratory communication is optimal prior to doing a full-fledged randomized clinical trial.", - "NCTID": "NCT00867841" - }, - { - "brief_title": "Clinical Trials to Reduce the Risk of Antimicrobial Resistance", - "phase": "Phase 2", - "drugs": "['IV meropenem', 'I.V. Meropenem', 'Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h', 'Linezolid or Vancomycin (per institutional guidelines) will be available for MRSA coverage.', 'tobramycin nebulization']", - "drugs_list": [ - "IV meropenem", - "I.V. Meropenem", - "Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h", - "Linezolid or Vancomycin (per institutional guidelines) will be available for MRSA coverage.", - "tobramycin nebulization" - ], - "diseases": "['Bacterial Pneumonia']", - "diseases_list": [ - "Bacterial Pneumonia" - ], - "enrollment": "43.0", - "inclusion_criteria": "inclusion criteria: \n\n Written informed consent by the subject/subject's LAR. \n\n Hospitalized males or females \u2265 18 yrs with respiratory failure requiring mechanical ventilation and clinical suspicion of HABP, HCAP or VABP. \n\n Onset or exacerbation of pneumonia at least 48 hours after admission to any patient health care facility or onset of pneumonia in a nursing home or rehabilitation facility with subsequent transfer to an acute care facility \n\n Women of childbearing potential if their pregnancy test is negative \n\n Subjects who have received previous antibacterial therapy within 14 days of pre-treatment bronchoscopy entry may be entered only if the subject has not responded clinically.). While less than 24 hours of pre-treatment antibiotics is preferential, recovery of >104 CFU/ml in the quantitative Bronchoscopic BAL will be seen as primary evidence that the prior therapy was not efficacious and enrollment will be allowed.) \n\n Patients should have clinical findings that support a diagnosis of HABP/VABP/HCAP: \n\n Within 48 hours before starting empiric therapy a subject's chest radiograph should show the presence of a NEW or progressive infiltrate, cavitation, or effusion suggestive of pneumonia \n\n Within 36 hours before the start of empiric study therapy, a quantitative culture of Bronchoscopic BAL fluid must be obtained. \n\n Patients with VABP should have a Clinical Pulmonary Infection Score of >/= 5. \n\n ", - "exclusion_criteria": ": \n\n Subjects with pneumonia caused by pathogens resistant to meropenem (MIC greater than or equal to 16\u00b5g/ml) or a prior meropenem therapy failure. \n\n Subjects with contra-indications to ANY study medication, in particular with known or suspected allergy or hypersensitivity. \n\n Women who are pregnant or lactating. \n\n Subjects taking anticonvulsant medications for a known seizure disorder.Patients with a history of seizures, AND who are stabilized on anti-seizure medication, may be enrolled into the study at the discretion of the site investigator. \n\n Subjects with known or suspected community acquired bacterial pneumonia (CABP) or viral pneumonia; or Subjects with acute exacerbation of chronic bronchitis without evidence of pneumonia. \n\n Subjects with primary lung cancer or another malignancy metastatic to the lungs. \n\n Subjects who were previously enrolled in this study. \n\n Subjects who have had an investigational drug or have used an investigational device within 30 days prior to entering the study. \n\n Subjects with another focus of infection requiring concurrent antibiotics that would interfere with evaluation of the response to study drug. \n\n Subjects with cystic fibrosis, AIDS with a CD4 lymphocyte count <200 cells/\u00b5l, neutropenia (absolute neutrophil count <500 cells/ml), known or suspected active tuberculosis. \n\n Subjects with little chance of survival for the duration of study therapy. \n\n Subjects with an APACHE II score >35. \n\n Subjects with underlying condition(s) which would make it difficult to interpret response to the study drugs. \n\n Subjects with hypotension or acidosis despite attempts at fluid resuscitation. Subjects requiring ongoing treatment with vasopressors will be eligible for the study if their hypotension is controlled and acidosis has resolved. Subjects with intractable septic shock are not eligible for enrollment. \n\n Subjects who have undergone bone marrow transplantation. \n\n Subjects with profound hypoxia as defined by a PaO2/FiO2 ratio <100.", - "brief_summary": "The primary objective of this study is to demonstrate a low rate of emergence of antibiotic resistance in P. aeruginosa and Acinetobacter spp during the treatment of hospitalized patients with pneumonia requiring mechanical ventilation treated with PD optimized meropenem administered as a prolonged infusion in combination with a parenteral aminoglycoside plus tobramycin by inhalation (Group 1) compared to therapy with meropenem alone (Group 2 - control arm).", - "NCTID": "NCT01570192" - }, - { - "brief_title": "A Registry Study on Hospitalized Patients With Community-acquired Pneumonia in Real-life of China", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Community Acquired Pneumonia']", - "diseases_list": [ - "Community Acquired Pneumonia" - ], - "enrollment": "3000.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients > or = 14 years of age \n\n Patient meets the criteria of community acquired pneumonia \n\n Patient meets the criteria of healthcare-associated pneumonia \n\n Informed consent to participate in the study is provided \n\n ", - "exclusion_criteria": ": \n\n Patients participating in a clinical trial or other intervention studies \n\n Patients <14 years of age \n\n Patient meets the criteria of hospital acquired pneumonia \n\n Known active tuberculosis or current treatment for tuberculosis \n\n Non-infectious pulmonary diseases \uff08e.g. pulmonary embolism, pulmonary edema, pulmonary vasculitis, interstitial pneumonia\uff09 \n\n HIV positive", - "brief_summary": "The purpose of this study is to evaluate the disease burden of hospitalized patients with CAP and HCAP in real life of China", - "NCTID": "NCT02492425" - }, - { - "brief_title": "Improving Antibiotic Use in Hospitalized Patients With Pneumonia", - "phase": "", - "drugs": "['ASP review']", - "drugs_list": [ - "ASP review" - ], - "diseases": "['Pneumonia']", - "diseases_list": [ - "Pneumonia" - ], - "enrollment": "763.0", - "inclusion_criteria": "inclusion criteria: \n\n have a positive Febrile Respiratory Illness (FRI) screen on admission to hospital (http://www.health.gov.on.ca/fr/public/programs/emu/sars/reports/dir_122303_acute_care_nonoutbreak.pdf) \n\n diagnosed with pneumonia by the admitting physician (Acute exacerbations of chronic obstructive lung disease are considered within the definition of pneumonia for the purposes of this study as they are commonly treated with the same antimicrobial regimens as patients with pneumonia) \n\n admitted to a medical ward \n\n ", - "exclusion_criteria": ": \n\n hospitalized for \u2265 48 consecutive hours in the preceding 3 months \n\n receiving immunosuppressants [defined as \u2265 40 mg prednisone daily (or steroid equivalent) for \u2265 2 weeks preceding hospitalization OR any other immunosuppressant used for systemic illness OR to prevent transplant rejection] \n\n neutropenic [defined as a polymorphonuclear count \u2264 0.5 x 109 cells/L] from any cause \n\n immunocompromised [defined as having leukemia, lymphoma, HIV with CD4 cell count \u2264 200, splenectomy or on cytotoxic chemotherapy] \n\n admitted to high acuity units such as intensive care units \n\n require mechanical ventilation, either non-invasive or invasive \n\n have a life expectancy of \u2264 3 months (palliative)", - "brief_summary": "The purpose of the study is to determine whether an antimicrobial stewardship program can decrease the length of hospital stay for patients with pneumonia. The antimicrobial stewardship program is run by a pharmacist and doctor with extensive training in managing infectious diseases. These two health care professionals are responsible for reviewing the records of patients admitted to hospital with pneumonia, and then making specific recommendations to the patient's attending physician about how to manage antibiotic treatment. These recommendations might include discontinuing the antibiotic, or changing the way antibiotics are delivered from intravenous form to pill form, among many other potential options. The attending physician considers whether these recommendations should be followed or rejected. The study has a control group of patients who are not reviewed by the antimicrobial stewardship team, and their length of hospital stay will be compared to the reviewed group of patients. Any differences between these two groups will be assumed to be due to the impact of the antimicrobial stewardship program. So far, no previous study has been able to demonstrate that an antimicrobial stewardship program can reduce the length of stay of patients admitted to hospital with pneumonia. This study has some important differences from previous studies that may make its conclusions more accurately reflect the true impact of antimicrobial stewardship programs. The most important difference is how the timing of the review is modelled in the analysis of the study results. Because the timing of the review varies between patients, with some patients being reviewed at earlier and some at later times, this subtle difference, if not accounted for in the analysis, can mask a true positive effect of the program on length of stay. The investigators study will account for this variation.", - "NCTID": "NCT02264756" - }, - { - "brief_title": "Assessment of Cough and Wheeze With Breath Sound Documenting Device", - "phase": "", - "drugs": "['PulmoTrack\u00ae 2010 with WIM-PC\u2122 and WIM-CC\u2122 Technologies']", - "drugs_list": [ - "PulmoTrack\u00ae 2010 with WIM-PC\u2122 and WIM-CC\u2122 Technologies" - ], - "diseases": "['Respiratory Sounds']", - "diseases_list": [ - "Respiratory Sounds" - ], - "enrollment": "55.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient and/or parents/guardian signed informed consent \n\n Patients with cough or shortness of breath \n\n ", - "exclusion_criteria": ": \n\n Chest tubes \n\n Skin lesions precluding attachment of sensors \n\n Respiratory distress \n\n Pregnant women", - "brief_summary": "The study goal is to create a database of respiratory sounds recordings, to evaluate and validate the WIM technology and to evaluate the efficacy of a specific treatment by comparing the severity of the respiratory symptoms before and after the administration of the treatment.", - "NCTID": "NCT00711399" - }, - { - "brief_title": "Impact of a Regional Antimicrobial Stewardship on the Length of Stay of Patients Admitted to Hospital With Pneumonia", - "phase": "", - "drugs": "['antimicrobial stewardship']", - "drugs_list": [ - "antimicrobial stewardship" - ], - "diseases": "['Pneumonia']", - "diseases_list": [ - "Pneumonia" - ], - "enrollment": "1400.0", - "inclusion_criteria": "inclusion criteria: \n\n Community-acquired pneumonia \n\n Immunocompetent \n\n Age > 18 years \n\n ", - "exclusion_criteria": ": \n\n Admitted to an intensive care unit or high intensity unit \n\n Requiring invasive or non-invasive ventilation \n\n Life expectancy less than 3 months \n\n Hospitalization within the previous 3 months for at least 48 consecutive hours \n\n Immunocompromised defined as defined as having leukemia, lymphoma, HIV with CD4 count <=200, splenectomy or on cytotoxic chemotherapy \n\n Neutropenic [defined as a PMN count<=0.5x109 cells/L] from any cause \n\n Receiving immunosuppressants [defined as >=40 mg prednisone daily (or steroid equivalent) for >=2 weeks preceding hospitalization OR any other immunosuppressant used for systemic illness OR to prevent transplant rejection", - "brief_summary": "This study evaluates the effectiveness of an antimicrobial stewardship program to reduce the length of stay of patients admitted to hospital with a diagnosis of pneumonia. The antimicrobial stewardship program will be implemented in several hospitals in Ontario, Canada. The program will identify patients with pneumonia, review their charts and make recommendations to their attending physicians about antibiotic management.", - "NCTID": "NCT02276092" - } - ] - }, - { - "patient_id": "sigir-201525", - "patient": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", - "0": [ - { - "brief_title": "Molecular Microbiology in Osteo-arthritis Infection", - "phase": "", - "drugs": "['Microbiological cultures and Molecular biology']", - "drugs_list": [ - "Microbiological cultures and Molecular biology" - ], - "diseases": "['Osteoarticular Infections']", - "diseases_list": [ - "Osteoarticular Infections" - ], - "enrollment": "229.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient are more than 18 years old \n\n Patient who do not declined to have his medical records reviewed for research \n\n Spondylodiscitis (S) group: \n\n Patients suspected of Discitis and/or Vertebral Osteomyelitis is defined by the need of spinal biopsy in infectious context. Spinal biopsies will be justified by one or more clinical or imaging findings: \n\n Clinical presentation \n\n Spinal pain unrelieved by rest \n\n Localized tenderness, Neurological deficits or limited range of motion \n\n Fever > 38\u00b0C \n\n Imaging findings (plain radiographs, MRI or CT): \n\n Erosions of end plates on adjacent vertebral bodies \n\n Decreased height of the intervertebral disk \n\n Presence of a nonvascularized zone suggesting presence of pus or necroses in intervertebral, epidural space or in paraspinal soft-tissues \n\n Prosthetic Joint Infection (PJI) Group \n\n Patients suspected of Prosthetic Joint Infection were defined by the need of surgical revision for diagnostic or therapeutic aiming in infectious context. This revision will be justified by one or more clinical, biological or imaging findings: \n\n Clinical presentation \n\n Persistent joint pain \n\n Fever > 38\u00b0C \n\n Erythematous, swollen, fluctuant, and/or tender surgical wound \n\n Wound dehiscence \n\n Limited range of joint motion \n\n Biological findings \n\n CRP > 10 mg/l \n\n Synovial leukocytes count > 1500/mm3 and polymorphonuclear leukocytes > 65% \n\n Imaging findings \n\n Prosthesis loosening: Periprosthetic osteolysis, progressive peri-prosthetic edging \n\n Scintigraphy by means of a technetium (Tc99m) scan, gallium citrate (Ga67) scan, or indium (In111)-labeled leukocyte showing fixation around the prosthesis. \n\n Septic arthritis (SA) Group \n\n Patients suspected of Septic arthritis without prosthesis were defined by the need of synovial punction and/or biopsy justified by one or more clinical, biological or imaging findings: \n\n Clinical presentation \n\n Acute joint pain and/or swelling \n\n Adenopathy near inflammatory joint \n\n Fever > 38\u00b0CBiological findings \n\n WBC > 10 000/ mm3 \n\n CRP > 10 mg/l \n\n Synovial leukocytes count > 2000/mm3 or polymorphonuclear leukocytes > 90% \n\n Imaging findings: \n\n Capsular and surrounding soft-tissues swelling \n\n Synovial notch and/or demineralization \n\n Periarticular Abscess \n\n ", - "exclusion_criteria": ": \n\n Patients already include. \n\n Patient without health insurance \n\n Antibiotic treatment before sampling does not constitute an exclusion criterion \n\n ", - "brief_summary": "Osteoarticular infections are painful and disabling diseases that require antimicrobial treatment adapted to the microorganisms implicated. Microbiological cultures are currently regarded as the reference for identification of pathogenic bacteria. However, the sensitivity of these cultures is very variable and depends both on the context in which clinical samples are taken, and on the pathogen involved. The rate of detection varies according to infection type: from 50 to 70% for infectious spondylodiscitis, 65 to 95% for prosthetic joint infections, 50% for gonococcal arthritis and 90% for non-gonococcal arthritis. The aim of the study is to evaluate the diagnostic performances of microbiological cultures and molecular methods in case of osteoarticular infections. The gold standard will be established by an expert group of osteoarticular infection (composed by a bacteriologist, a radiologist, a surgeon, an anatomy-pathologist and a rheumatologist), which established the final diagnosis of infected or not infected patients.", - "NCTID": "NCT01193803" - }, - { - "brief_title": "Clinical and Radiological Results of Osteochondral Repair Using MaioRegen in Knee and Ankle Surgery", - "phase": "", - "drugs": "['implantation of MaioRegen fleece into osteochondral lesion']", - "drugs_list": [ - "implantation of MaioRegen fleece into osteochondral lesion" - ], - "diseases": "['Osteochondral Lesion of Talus', 'Degenerative Lesion of Articular Cartilage of Knee']", - "diseases_list": [ - "Osteochondral Lesion of Talus", - "Degenerative Lesion of Articular Cartilage of Knee" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria: \n\n single osteochondral lesion in knee/ankle (2-4 sq cm) \n\n ", - "exclusion_criteria": ": \n\n multiple osteochondral lesions \n\n pre-existing injuries/arthropathies", - "brief_summary": "Osteochondral lesions in knee and ankle are injuries commonly seen in young patients. MaioRegen fleece is a cartilage substitute which can be used in circumscribed defects.~This prospective study follows patients treated with MaioRegen implants from pre-surgery until 24 months post-surgery.", - "NCTID": "NCT02345564" - }, - { - "brief_title": "Assessment of Protective Effect of JOINS on Cartilage in Knee Osteoarthritis", - "phase": "Phase 4", - "drugs": "['JOINS 200mg', 'Placebo']", - "drugs_list": [ - "JOINS 200mg", - "Placebo" - ], - "diseases": "['Knee Osteoarthritis']", - "diseases_list": [ - "Knee Osteoarthritis" - ], - "enrollment": "76.0", - "inclusion_criteria": "inclusion criteria: \n\n A female is eligible if she is of: \n\n Non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal \n\n Child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly \n\n Pregnancy test result of negative at screening \n\n Primary Knee OA(Osteoarthritis) on medial femorotibial compartment based on ACR(American College Rheumatology) Criteria. \n\n ACR Criteria : With Knee pain and satisfied at least 1 of 3 (\u2460 age > 50 years, morning stiffness < 30 minute, \u2462 Presence of Crepitus and Osteophytes on motion) \n\n Appropriately signed and dated informed consent has been obtained \n\n ", - "exclusion_criteria": ": \n\n Rheumatoid arthritis or inflammatory arthritis. \n\n Bilateral total knee replacement already treated, or planning for the procedure. \n\n Knee prosthesis already implanted, or foreseen within the next year. \n\n Clinically significant hip osteoarthritis. \n\n Severe renal insufficiency defined as creatinine clearance < 30ml/mln(Cockcroft formula). \n\n Clinically significant pulmonary, hepatic, renal or heart disorder or diagnosis crucial disease by investigator ( Glycosuria(Diabetes mellitus) or asthma patients are excluded from this clinical study and the patients who has a clinically significant disease are also excluded.). \n\n MRI contraindications : overweight, inferior limb diameter non-fitting the knee antenna, inserted pace-maker, metallic prosthesis( if known to interfere with MRI procedure or if known to be unsafe for MRI), metallic clips, insulin pump, cytostatic pump, hearing aid, essential tremor, claustrophobia, etc,. \n\n Allergic reaction to Clinical trial medication. \n\n Other clinical trial drugs during the 1 month prior to the screening visit.", - "brief_summary": "A Pilot study~Randomized and Double-blinded~Placebo controlled~In 2 parallel group (JOINS 200mg:Placebo = 1:1)~Overall 24 months treatment (JOINS:Placebo comparison up to 12 months, Additional follow-up assessment up to 24 months)~Provide rescue medicine throughout whole clinical trial period.", - "NCTID": "NCT01293955" - }, - { - "brief_title": "Study of OLT1177 Gel to Treat Moderate to Severe OA Knee Pain", - "phase": "Phase 2", - "drugs": "['Placebo Gel', 'OLT1177 Gel']", - "drugs_list": [ - "Placebo Gel", - "OLT1177 Gel" - ], - "diseases": "['Osteoarthritis', 'Pain']", - "diseases_list": [ - "Osteoarthritis", - "Pain" - ], - "enrollment": "202.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 45 to 80 years old, inclusive \n\n Clinical diagnosis of osteoarthritis in one target knee based on the following American College of Rheumatology (ACR) criteria: \n\n Knee Pain \n\n At least 1 of 3: \n\n Age > 50 years \n\n Morning stiffness lasting < 30 minutes \n\n Crepitus on motion \n\n Osteophytes on radiograph \n\n Symptoms associated with osteoarthritis of the knee (including pain) for \u2265 6 months prior to Screening \n\n Knee pain associated with osteoarthritis, which required NSAID or other therapy for \u2265 15 days during the preceding month \n\n Radiographic evidence of osteoarthritis by Kellgren-Lawrence classification with a rating of Grade 2 or 3 in the target knee (does not include borderline Grade 2), as confirmed by the Sponsor's designated rheumatologist through radiographic review of x-ray(s) taken no more than 1 year prior to the Screening visit. (Sharpening of the tibial spine is not considered to be an osteophyte) (See Appendix 4 for additional details) \n\n Meets pain assessment entry criteria as defined by Sponsor's pain eligibility algorithm and calculated by the study Interactive Web Response System \n\n No clinically significant change in physical activity and/or therapy for the past 3 months \n\n Able to provide written informed consent prior to initiation of any clinical trial-related procedures; and willing and able, in the opinion of the Investigator, to comply with all requirements of the clinical trial for the duration of the trial (such requirements include, but are not limited to: attending all study visits, refraining from elective surgery or extensive travel during participation) \n\n ", - "exclusion_criteria": ": \n\n General \n\n Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential may not be entered into the study if: \n\n They are or intend to become pregnant (including use of fertility drugs) during the study \n\n They are nursing \n\n They are not using an acceptable, highly effective method of contraception until all follow-up procedures are complete. (Acceptable, highly effective forms of contraception are defined as: oral contraception, intrauterine device, systemic [injectable or patch] contraception, double barrier methods, naturally or surgically sterile, strict abstinence or partner has been sterilized. If hormonal-based birth control is being used, subject or subject's sexual partner(s) must be on a stable-dose for \u2265 3 months prior to the Baseline visit and maintained at the same dosing level throughout the 9-week clinical trial.) \n\n Body Mass Index (BMI) over 40 \n\n A history of osteoarthritis symptoms that are completely non-responsive to non-steroidal anti-inflammatory drugs (NSAIDs) at the discretion of the Investigator \n\n Planned change (increase or decrease) in subject's level of physical activity (e.g., aerobic or anaerobic exercise) during the 6-week Treatment Period following randomization \n\n Enrollment in any trial and/or use of any Investigational Drug or device within the immediate 30-day period prior to the Baseline visit \n\n Enrollment in any study previously sponsored by Olatec Industries LLC, specifically Study OLT1177-01 or OLT1177-02 \n\n Pain Related \n\n Does not meet pain assessment entry criteria as defined by Sponsor's pain eligibility algorithm and calculated by the study Interactive Web Response System \n\n Clinically significant joint (other than the knee) or general pain at Baseline, at the discretion of the Investigator \n\n Musculoskeletal Related \n\n Clinically significant, excessive effusion heat and/or redness in the target knee as determined by the Investigator \n\n Knock-kneed or bow-legged, as defined by a valgus or varus deformity of \u2265 15 degrees \n\n Radiographic evidence of osteoarthritis by Kellgren-Lawrence classification with a rating of Grade 0, 1 or 4 in the target knee, as confirmed by the Sponsor's designated rheumatologist through radiographic review of x-ray(s) taken no more than 1 year prior to the Screening visit (sharpening of the tibial spine is not considered to be an osteophyte) \n\n Documented history of clinically significant pain associated with osteoarthritis of the spine or hips, at the discretion of the Investigator \n\n Significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or chondromalacia \n\n Clinically significant medio-lateral and/or anterior-posterior instability, at the discretion of the Investigator \n\n Open surgery of the target knee within the prior year or surgery to the contralateral knee or other weight-bearing joint within the prior year, if at the discretion of the Investigator it would interfere with the study. If subject had open surgery more than one-year prior, Sponsor's designated rheumatologist must confirm that such surgery did not have any negative impact or consequence to the target knee (e.g., deformity of angle to the bone, bone on bone, locking joints, etc.) \n\n Arthroscopic surgery of the target knee within the prior six months \n\n Any acute or chronic injury, other than osteoarthritis in the target knee, that will be treated during the trial with any medication not allowed during the Treatment Period \n\n Prior surgery of the target knee requiring insertion of a medical device or surgical hardware (e.g., screws) \n\n Any major trauma or injury (including sports injuries) to the target knee in the past 12 months \n\n Documented history of inflammatory joint disease, including but not limited to: rheumatoid arthritis, gout, pseudogout, Paget's disease, psoriatic arthritis, ankylosing spondylitis, chronic inflammatory disease (e.g., colitis), fibromyalgia (diagnosed in accordance with ACR criteria, as applicable), articular fracture, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders (e.g., hypermobility) or collagen gene mutations \n\n Any planned interventional and/or surgical procedure during the 6-week Treatment Period following randomization \n\n Concomitant Conditions, Diseases, Medications/Therapies and Medical History Related \n\n Any use of Rescue Medication within 24 hours prior to the Baseline visit or use of any other pain medication within 7 days prior to Baseline visit \n\n Uncontrolled hypertension, defined as blood pressure \u2265 150/95 mmHg \n\n A history of uncontrolled and untreated diabetes mellitus with an HbA1c level > 8; or blood sugar levels that are outside of the normal range and HbA1c level > 8 is subsequently confirmed \n\n Any inflammatory skin condition over the target knee application area \n\n Use of any prohibited concomitant medications/therapies during the 7-day Washout Period or planned use of any prohibited concomitant medications/therapies during the 6 week Treatment Period \n\n Use of intraarticular or intramuscular steroids in the target knee within the previous 3 months or in any other joint within the previous 30 days \n\n Use of intraarticular hyaluronate in the target knee within the previous 6 months or in any other joint within the previous 30 days \n\n Current substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse (including alcoholism and/or addiction to pain medications) that is determined at the discretion of the Investigator as likely to interfere with trial assessments or recur during the trial \n\n Use of any systemic (oral or parenteral) corticosteroids within the prior month \n\n Uncontrolled psychiatric conditions (e.g., mania, depression, anxiety, substance dependence of any kind) that would impair the subject from safely participating in the trial, including completing any protocol requirements \n\n Evidence of cognitive impairment including dementia that may interfere with subject's ability to complete daily pain diaries requiring recall of average pain level in the past 24 hours \n\n Significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological or neurological disease or prior surgery that may interfere with the subject successfully completing the trial, including completing any protocol requirements as determined by the Investigator \n\n History of or known positive for HIV, Hepatitis B surface antigen (HBsAg) or antibodies to Hepatitis C Virus (HCV) \n\n Diagnosed with any form of cancer within the past 5 years, except for treated basal cell or squamous cell carcinoma of the skin \n\n Any other medical conditions, diseases or prior surgeries that in the opinion of the Investigator would impair the subject from safely participating in the trial and/or completing any protocol requirements \n\n Active infection within 3 days of the Baseline visit", - "brief_summary": "The objectives of this trial are to investigate the efficacy and safety of six weeks of treatment with OLT1177 Gel in subjects with moderate to severe pain associated with osteoarthritis of the knee following cessation of pain therapy.", - "NCTID": "NCT02104050" - }, - { - "brief_title": "Studying DNA in Tumor Tissue Samples From Patients With Localized or Metastatic Osteosarcoma", - "phase": "", - "drugs": "['DNA analysis', 'RNA analysis', 'gene expression analysis', 'gene rearrangement analysis', 'mutation analysis', 'laboratory biomarker analysis']", - "drugs_list": [ - "DNA analysis", - "RNA analysis", - "gene expression analysis", - "gene rearrangement analysis", - "mutation analysis", - "laboratory biomarker analysis" - ], - "diseases": "['Sarcoma']", - "diseases_list": [ - "Sarcoma" - ], - "enrollment": "99.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Diagnosis of localized or metastatic osteosarcoma \n\n Banked snap-frozen tumor tissue samples and paired blood DNA samples available \n\n PATIENT CHARACTERISTICS: \n\n Not specified \n\n PRIOR CONCURRENT THERAPY: \n\n Not specified", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.~PURPOSE: This research study is looking at DNA in tumor tissue samples from patients with localized or metastatic osteosarcoma.", - "NCTID": "NCT01062438" - }, - { - "brief_title": "Evaluating the Safety and Efficacy Civamide in Osteoarthritis (OA) of the Knee(s)", - "phase": "Phase 3", - "drugs": "['Civamide (Zucapsaicin)']", - "drugs_list": [ - "Civamide (Zucapsaicin)" - ], - "diseases": "['Osteoarthritis of the Knee']", - "diseases_list": [ - "Osteoarthritis of the Knee" - ], - "enrollment": "695.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to entry into the Screening Period (Day -3). \n\n Subject has OA pain of the Target Knee with a WOMAC Pain Subscale baseline value of > 9 at the Baseline/Randomization Period (Maximum score is 20 for 5 questions with 0 = none; 4 = extreme. \n\n Subject must have a Functional Capacity Classification of I-III. \n\n Subject has taken a stable dose of NSAIDs or COX-2 inhibitor agents for OA pain for at least 22 of the previous 28 days and for each of the 2 days prior to the Screening Period (Day -3) and for at least each of the 2 days prior to the Baseline/Randomization Period (Day 1). Subject must also, agree and be expected to remain on this stable daily dose throughout the study. \n\n Subject is between 40-75 years of age. \n\n Diagnosis of OA is present for at least 6 months according to the ACR criteria for OA of the knee. \n\n Radiographic evidence of OA of the Target Knee (within the last 3 years) with a Kellgren-Lawrence scale of 2 or 3. \n\n Subject is generally in good health. \n\n Subject is expected to be compliant with study procedures. \n\n Females of child-bearing potential must have a negative urine pregnancy test at Screening. \n\n Female subjects of child-bearing potential agree to use an approved form of contraception and must be on the same contraceptive method and dosage schedule during the entire study. \n\n ", - "exclusion_criteria": ": \n\n Presence of tendonitis, bursitis, partial or complete joint replacement of Target Knee. \n\n Presence of active skin disease, erythema, infection, wound or irritation near the treatment area of the Target Knee. \n\n Subject has history of frequent headache or other painful conditions (other than OA) that is expected to require any use of systemic opiates or derivatives, or more than twice a week additional administration of different oral NSAIDs or COX-2 inhibitors (see Section 6.1, Table 2). \n\n Subject experiences regular significant pain due to osteoarthritis or other conditions in the non-target knee or other joints while on stable doses of their current analgesic therapy. \n\n Subject has an anticipated need for any surgical or other invasive procedure that will be performed on the Target Knee or other part of the body during the course of the study. \n\n OA secondary to local joint disorders (e.g., mechanical disorder, internal derangement of the knee), systemic metabolic disease, endocrine disorders, bony dysplasia, calcium crystal deposition disease, neuropathic arthropathy, frostbite, congenital abnormalities. \n\n Subject has history and/or diagnosis of rheumatoid arthritis, fibromyalgia, connective tissue disease, psoriatic arthritis, erosive inflammatory OA, diffuse idiopathic skeletal hyperostosis, severe neurologic or vascular disease. \n\n Subject has active (redness, swelling, fever, etc.) gout/pseudogout within 6 months prior to screening. \n\n Subject has Type I or Type II diabetes with peripheral neuropathies. \n\n Subject is extremely obese with BMI \u2265 39. \n\n Subject has had trauma to or surgery on the Target Knee within 1 year of Screening/Baseline. \n\n Subject has an underlying clinical condition, including previous malignancies that in the Investigator's judgment, is unstable. \n\n Subject has known allergy or hypersensitivity to capsicum, civamide, or capsaicin-containing products or any constituent of the cream formulation. \n\n Subject has a history of substance abuse within the past 12 months. \n\n Subject has participated in previous clinical study with Civamide Cream. \n\n Use of restricted medications (See Medication/Treatment Table, Section 5.1.2).", - "brief_summary": "To evaluate the safety and efficacy of Civamide Cream 0.075% as a treatment of the signs and symptoms associated with osteoarthritis of the knee.", - "NCTID": "NCT00995306" - }, - { - "brief_title": "Genetic Biomarkers in Tissue Samples From Patients With Osteosarcoma", - "phase": "", - "drugs": "['laboratory biomarker analysis']", - "drugs_list": [ - "laboratory biomarker analysis" - ], - "diseases": "['Osteosarcoma']", - "diseases_list": [ - "Osteosarcoma" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Samples from the COG tissue repository", - "exclusion_criteria": "", - "brief_summary": "This clinical trial studies genetic biomarkers in tissue samples from patients with osteosarcoma. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer", - "NCTID": "NCT01807143" - }, - { - "brief_title": "Dynamic Splinting After Total Knee Arthroplasty", - "phase": "", - "drugs": "['Knee Extension Dynasplint']", - "drugs_list": [ - "Knee Extension Dynasplint" - ], - "diseases": "['Reduced Knee Flexion']", - "diseases_list": [ - "Reduced Knee Flexion" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n Reduced flexibility in AROM of knee extension \n\n Pain that is worsened by bending over while legs are straight \n\n Impaired gait pattern \n\n Ability to understand informed consent and experiment responsibilities \n\n ", - "exclusion_criteria": ": \n\n Fractures \n\n Knee sepsis \n\n Osteomyelitis or any orthopedic infection \n\n Extensor mechanism dysfunction \n\n Psoriasis \n\n Knee joint neuropathy \n\n Previous Stroke or Brain Injury", - "brief_summary": "The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for knee flexion contracture following a total knee arthroplasty.", - "NCTID": "NCT00857701" - }, - { - "brief_title": "Biomarker Expression in Tissue Samples From Patients With Bone Sarcomas", - "phase": "", - "drugs": "['laboratory biomarker analysis']", - "drugs_list": [ - "laboratory biomarker analysis" - ], - "diseases": "['Localized Osteosarcoma', 'Metastatic Osteosarcoma', 'Recurrent Osteosarcoma']", - "diseases_list": [ - "Localized Osteosarcoma", - "Metastatic Osteosarcoma", - "Recurrent Osteosarcoma" - ], - "enrollment": "34.0", - "inclusion_criteria": "inclusion criteria: \n\n Tissue samples from patients with osteosarcomas obtained from the CHTN: \n\n P9754 clinical trial for patients with non-metastatic osteosarcoma \n\n AOST0121 clinical trial for patients with metastatic or recurrent osteosarcoma", - "exclusion_criteria": "", - "brief_summary": "This trial studies biomarker expression in tissue samples from patients with bone sarcomas. Studying biomarker in tissue samples from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer", - "NCTID": "NCT01807052" - }, - { - "brief_title": "Ultrasonography Assessment of Septic Arthritis on Native Joint", - "phase": "", - "drugs": "['Ultrasonography assessment']", - "drugs_list": [ - "Ultrasonography assessment" - ], - "diseases": "['Septic Arthritis']", - "diseases_list": [ - "Septic Arthritis" - ], - "enrollment": "28.0", - "inclusion_criteria": "inclusion criteria: \n\n Major patients hospitalized in Rheumatology, Infectiology, Orthopedy Department (hospital of Nantes, of La Roche sur Yon and of Saint-Nazaire) with a septic arthritis of shoulder, or elbow, or wrist , or hip, or knee, or ankle on native joint, with positive microbiologic culture joint fluid or positive hemoculture; the diagnosis was based on positive histology or imagery with an inflammatory joint fluid if the microbiologic cultures (hemoculture or joint effusion) were negative. \n\n ", - "exclusion_criteria": ": \n\n Presence of material on the targeted joint \n\n Age < 18 years old \n\n Patients under guardianship \n\n Pregnancy", - "brief_summary": "The aim of this trial is to study the interest of ultrasonography among patients with septic arthritis.~Currently, ultrasonography is useful for detecting small fluid effusions, for examining otherwise inaccessible joints, such as the hip and for helping the joint aspiration.~Accurate assessment of disease activity and joint damage in septic arthritis is important for monitoring treatment efficiency and for prediction of the outcome of the disease.~Nowadays, magnetic resonance imaging (MRI) provides better resolution than radiography or tomography for the detection of joint effusion and for differentiation between bone and soft tissue infectious. The sensibility is reported to be nearly 100% with a specificity of more than 75%.~However, MRI is expensive and not rapidly accessible.~Therefore, ultrasonography, a non invasive, painless, inexpensive, and non radiating exam can be used to assess the presence and extent of inflammation, destruction, and tissue response.~The objective is to describe, using ultrasonography, the abnormalities joint structure influenced the septic arthritis evolution and prognosis.~The investigators hope, at the end of this study, to evaluate ultrasonography interest in septic arthritis and to establish ultrasonography prognosis factors to predict treatment efficiency and functional outcome.", - "NCTID": "NCT02018952" - }, - { - "brief_title": "A Comparison Between Signature Total Knee Arthroplasty (TKA) to Conventional TKA and Computer Assisted TKA", - "phase": "", - "drugs": "['Signature Knee Guide', 'Conventional Instrumentation', 'Computer Assisted Navigation']", - "drugs_list": [ - "Signature Knee Guide", - "Conventional Instrumentation", - "Computer Assisted Navigation" - ], - "diseases": "['Joint Disease']", - "diseases_list": [ - "Joint Disease" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient is of legal age and skeletally mature \n\n Patient requires primary total knee arthroplasty due to non- inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, a vascular necrosis, dysplasia/DDH) or inflammatory joint disease (e.g., Rheumatoid arthritis). \n\n Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, haematological, etc., conditions that would pose excessive operative risk \n\n The patient will be available for follow up throughout the duration of the study. \n\n ", - "exclusion_criteria": ": \n\n Patient is unable to have an MRI scan due to the following conditions: \n\n Cardiac pacemaker \n\n Surgical clips in head (aneurysm clips) \n\n Some artificial heart valves \n\n Electronic inner ear implants \n\n Metal fragments in eyes \n\n Electronic stimulators \n\n Implanted pumps \n\n Patient has active infection or sepsis (treated or untreated) \n\n Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery. \n\n Patient is female of child-bearing age and not taking contraceptive precautions. \n\n Patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia). \n\n Patient has known moderate to severe renal insufficiency. \n\n Patient has a known or suspected metal sensitivity. \n\n Patient is immunosuppressed or receiving high doses of corticosteroids. \n\n Patient has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, or drug, alcohol abuse. \n\n Patient has BMI >40.", - "brief_summary": "This is a prospective, randomised clinical outcomes study comparing the Signature Personalised Patient Care, Conventional Total Knee Arthroplasty and Computer Assisted Navigation, using Vanguard Knee System. The aim of the study is to evaluate the safety and efficacy of TKA using Signature Personalised Patient Care compared to Conventional TKA and Computer Assisted Navigation.", - "NCTID": "NCT01145157" - }, - { - "brief_title": "A Study of the Effectiveness of Different Types of Exercise for People With Knee Osteoarthritis", - "phase": "", - "drugs": "['Kinesthesia, Balance, and Agility (KBA) Exercise', 'Standard LE Strength Training']", - "drugs_list": [ - "Kinesthesia", - "Balance", - "and Agility (KBA) Exercise", - "Standard LE Strength Training" - ], - "diseases": "['Knee Osteoarthritis']", - "diseases_list": [ - "Knee Osteoarthritis" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged 50 years or over of either gender \n\n Radiographic tibiofemoral OA grade 2 or higher, unilateral or bilateral \n\n Demonstrated knee OA related dysfunction per WOMAC score \n\n Not engaged in a regular exercise program for minimum of 6 months \n\n ", - "exclusion_criteria": ": \n\n Inability to obtain physician release for exercise \n\n High risk health status: \n\n e.g., uncontrolled medical conditions such as hypertension, diabetes, heart disease, pulmonary disease, high cholesterol, anginal type pain, dizziness or syncope, orthopnea or paroxysmal nocturnal dyspnea, ankle edema, heart palpitations or tachycardia, intermittent claudication, known heart murmur, unusual fatigue or shortness of breath with usual activities. \n\n Unresolved balance disorder \n\n Unresolved neurological disorder \n\n History of knee surgery or major knee trauma injury \n\n Hip or ankle instability, excessive weakness, surgery or major trauma injury \n\n Intra-articular joint injection within 4 weeks of the study", - "brief_summary": "This pilot study will test the testing and exercise training protocols for a larger study that is in the desing phase and may be modified based on the findings of this study. Two exercise groups will be compared; one is a stadard treatment group using leg strength exercises that are commonly employed in therapy clinics. The other group will do balance and agility type exercises, but no specific strength exercises. These KBA exercises are increasingly common in therapy clinics, but very little research has been conducted on their effectiveness in treating knee osteoarthritis symptoms. Participants in this study will complete three short paper and pencil tests at the beginning and end of the study (8 weeks of exercise) as well as a leg strength test, a leg endurance test, two short walking tests, and a stair climb/descend test. One of the paper and pencil tests will be taken every two weeks in an effort to see how quickly changes to symptoms might occur. The exercise programs will be conducted 3 afternoons per week (Mon-Wed-Fri) and will be lead by an ACSM certified instructor.", - "NCTID": "NCT00519922" - }, - { - "brief_title": "Effects of Hamstring Training in Different Modes on Stabilizing Knee Joints With Anterior Drawer Laxity", - "phase": "", - "drugs": "['plate-loaded kneeling leg curl with internal rotation', 'plate-loaded squat press', 'plate-loaded kneeling leg curl']", - "drugs_list": [ - "plate-loaded kneeling leg curl with internal rotation", - "plate-loaded squat press", - "plate-loaded kneeling leg curl" - ], - "diseases": "['Knee Instability']", - "diseases_list": [ - "Knee Instability" - ], - "enrollment": "28.0", - "inclusion_criteria": "inclusion criteria: \n\n The anterior drawer laxity of the knee joint in this study was defined as anterior displacement over 3 mm discrepancy between bilateral knee joints by a KT-2000 test under 20-pound force. \n\n ", - "exclusion_criteria": ": \n\n anterior displacement less than 3 mm discrepancy between bilateral knee joints by a KT-2000 test under 20-pound force.", - "brief_summary": "Question: To investigate how different modes of thigh muscles strengthening exercises emphasizing the knee internal rotators can be as effective as possible in improving the static stability and agility of the knees with anterior drawer laxity.~Design: Randomized controlled clinical trial.~Participants and Interventions:~Young men with anterior drawer laxity of the knee were randomly assigned to three experimental groups in different strengthening modes: plate-loaded squat press (SP), plate-loaded kneeling leg curl with internal rotation (KLCIR), and kneeling leg curl (KLC). The control group with stable knees received no training.~Outcome measures: static and dynamic knee stability, isokinetic strength. The purpose of this paper was to find out an optimal solution to the enhancement of the static and dynamic knee stability to a great extent.~Key words: anterior cruciate ligament; agility; knee stability; hamstring; knee internal rotator", - "NCTID": "NCT01170546" - }, - { - "brief_title": "A Randomized Trial Comparing the Lokomat\u00ae With a Gait-related Physiotherapy Program in Children With Cerebral Palsy", - "phase": "Phase 2", - "drugs": "['Lokomat', 'Physiotherapy']", - "drugs_list": [ - "Lokomat", - "Physiotherapy" - ], - "diseases": "['Cerebral Palsy']", - "diseases_list": [ - "Cerebral Palsy" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n age 5 to12 years inclusive \n\n assessed as GMFCS Levels II or III \n\n able to follow testing instructions, and participate in a minimum of 30 minutes of active PT \n\n able to reliably signal pain, fear and discomfort \n\n have passive range of motion (ROM) of hips and knees within minimum range requirement for Lokomat (hip and knee flexion contracture < 10 degrees, and knee valgus < 40 degrees) \n\n client of Child Development Program at Holland Bloorview \n\n able to commit to attendance of twice weekly for eight weeks (to support the primary efficacy analysis). \n\n ", - "exclusion_criteria": ": \n\n a fixed knee contracture > 10 degrees, knee valgus >40 degrees such that robotic leg orthosis will not be adaptable to lower limbs \n\n hip instability/subluxation > 45% \n\n orthopaedic surgery within the last 9 months (muscle) or 12 months (bone) \n\n Botulinum toxin-A (BTX-A) injections to lower limb in the last 4 months \n\n inability to discontinue BTX-A for period of 6 months (during trial) due to concerns about ROM or pain \n\n severe spasticity may be a contraindication \n\n any weightbearing restrictions \n\n seizure disorder that is not controlled by medication (if on medication, must not have had a seizure in the last 12 months) \n\n open skin lesions or vascular disorder of lower extremities \n\n not able to co-operate or be positioned adequately within the Lokomat as shown during the two Lokomat fitting/acclimatisation sessions \n\n not prepared or unable to discontinue a regular therapy intervention during the course of the trial \n\n involved in another intervention study", - "brief_summary": "The Lokomat is a robotic treadmill gait trainer that is used to help people who have neurologic conditions walk better. Early research with children with cerebral palsy (CP) shows that it may help to improve walking skills. The purpose of this two-group randomized study is to compare Lokomat training to regular physiotherapy (PT) as far as impact on walking abilities and related function. The primary (alternate) hypothesis is that children will improve more with Lokomat training in terms of gross motor skills and walking endurance.~The investigators are enrolling 40 ambulatory children who are ages 5 to 12 years, have CP and are in Gross Motor Function Classification System (GMFCS) Level II (n=20) or III (n=20). In this crossover randomized clinical trial (RCT), whether PT or Lokomat intervention is done first is decided by an independent randomization process that occurs after the first baseline assessment. In the Lokomat phase, children receive 8 to 10 weeks of twice weekly therapy for a maximum of 16 sessions. Each session is 35 minutes plus the time needed for set-up. The 35 minute PT program is also given twice weekly for 8 to 10 weeks for a maximum of 16 sessions, and focuses on a menu-based strength, co-ordination, fitness, walking and balance activities. There is a 6 week break between the Lokomat and PT interventions.~Each child has four study assessments during their ~6 months in the study. The first assessment is done before starting the Lokomat or physiotherapy phase. The second happens after the first intervention has finished. The child then has a 6-week break period. The third assessment is done at the end of this break, and the fourth occurs after the second intervention. The PT assessor who does these assessments will not be the same as the PT who gives the intervention. The assessor is blinded to the child's intervention phase and previous assessment results. The primary outcome measures are the Gross Motor Function Measure and 6 minute walk test. Secondary measures evaluate gait, functional abilities, participation, health related quality of life and individualized goals.~The randomized aspect of the study lets us look at outcome differences between children for Lokomat and PT within their first intervention phase (n=20/group). The cross-over phase evaluates within-child outcomes across the two phases. A qualitative component is concurrently underway to examine child/parent experiences and their views of Lokomat outcomes.", - "NCTID": "NCT02196298" - }, - { - "brief_title": "A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma", - "phase": "Phase 1", - "drugs": "['Anti-GD2 antibody']", - "drugs_list": [ - "Anti-GD2 antibody" - ], - "diseases": "['Neuroblastoma', 'Melanoma', 'Osteosarcoma', 'Ewing Sarcoma']", - "diseases_list": [ - "Neuroblastoma", - "Melanoma", - "Osteosarcoma", - "Ewing Sarcoma" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis: \n\n Part A: Recurrent or refractory neuroblastoma or melanoma. \n\n Part B: Recurrent or refractory neuroblastoma or melanoma. \n\n Part C: Recurrent or refractory osteosarcoma and Ewing sarcoma. \n\n Age: \u2264 21 years of age at the time of enrollment (i.e. participants are eligible until they reach their 22nd birthday). \n\n Does not have a clinically significant neurologic deficit or objective peripheral neuropathy (greater than or equal to grade 2). Peripheral (sensory or motor) neuropathy related to limb sparing procedure or amputation is allowed. \n\n Life expectancy: at least 8 weeks. \n\n Organ Function: Must have adequate organ and marrow function \n\n Performance status: Karnofsky \u2265 50 for > 10 years of age; Lansky \u2265 50 for children < 10 years of age. \n\n Prior Therapy: Patient must have fully recovered from the acute toxic effects of all prior therapy prior to enrolling on study. \n\n Myelosuppressive Chemotherapy: Must not have received myelosuppressive therapy within 2 weeks prior to study entry (4 weeks if nitrosurea). \n\n Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with biologic agent, including retinoic acid. Participants receiving IVIG are eligible; however, participant must not receive IVIG during the 4 days of antibody infusion. \n\n Radiation therapy: At least 2 weeks since prior local radiation therapy at the time of study entry. \n\n Growth factors: Must not have received hematopoietic growth factors (G-CSF, GM-CSF) for at least 1 week prior to study entry. \n\n Investigational agent: Must not have received investigational agent within 14 days of study entry. \n\n Immune therapy: Must not have received immunosuppressive (including glucocorticoids), immunostimulatory or any immunomodulatory treatment within 2 weeks of study entry. Steroid containing inhalers, steroid replacement for adrenal insufficiency and steroid premedication for prevention of transfusion or imaging contrast agent-related allergic reaction will be permitted. \n\n Patients may have had prior CNS metastasis providing: CNS disease has been previously treated and CNS disease has been clinically stable for 4 weeks prior to study entry (assessment must be made by CT or MRI). \n\n Written informed consent following institutional and federal guidelines. \n\n ", - "exclusion_criteria": ": \n\n Prior monoclonal antibody: Participants having received in vivo monoclonal antibodies for biologic therapy or for tumor imaging are eligible provided they did not experience a severe allergic reaction with the antibody. \n\n Pregnancy or Breast Feeding: Study participants who are pregnant are not eligible for this study. Pregnancy tests must be obtained in girls who are > 10 years of age or post-menarchal within 7 days prior to study enrollment. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method during participation in the trial. Breast feeding should be discontinued if a mother wishes to participate in this study. \n\n Allergy: known hypersensitivity to other recombinant human antibodies. \n\n An uncontrolled infection.", - "brief_summary": "Relapsed and/or refractory neuroblastoma, osteosarcoma, Ewing sarcoma and melanoma are considered difficult to treat and cure. For this study we are testing the use of a new experimental (investigational) antibody called hu14.18K322A. GD2 is expressed on the surface of most of these tumor types.~Two schedules of hu14.18K322A antibody will be evaluated in this study, (1) daily for four consecutive days schedule every 28 days and (2) once weekly for 4 weeks schedule every 28 days. Approximately 25-40 participants will be required to define the maximum tolerated dose for each schedule. Participants will continue on treatment for a maximum of 4 to 8 courses or until one or more of the criteria for off-treatment are met.", - "NCTID": "NCT00743496" - }, - { - "brief_title": "The Analgesic Effect of Combined Nerve Block and Systemic High Dose Glucocorticoid After Total Knee Arthroplasty.", - "phase": "Phase 4", - "drugs": "['Ropivacaine']", - "drugs_list": [ - "Ropivacaine" - ], - "diseases": "['Peripheral Nerve Block', 'Pain']", - "diseases_list": [ - "Peripheral Nerve Block", - "Pain" - ], - "enrollment": "74.0", - "inclusion_criteria": "inclusion criteria: \n\n Age> 50 years \n\n Patients set to cemented Total knee arthroplasty in spinal block \n\n ASA 1-3 \n\n ", - "exclusion_criteria": ": \n\n Patients who can not cooperate with the investigation \n\n Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations fully \n\n Patients who do not understand or speak Danish \n\n Patients receiving immunosuppressive therapy \n\n Patients receiving glucocorticoid daily \n\n Patients with a treatment-dependent diabetes mellitus \n\n Patients with known neuropathy in the lower limbs \n\n Allergy to those used in the study drugs \n\n Alcohol and / or drug abuse - the investigator's opinion \n\n Patients who can not tolerate NSAIDs \n\n Fixed several times daily consumption of strong opioids (morphine, ketogan, Oxynorm, methadone, fentanyl)", - "brief_summary": "Purpose:~The purpose of this study is to evaluate the postoperative analgesic effect of a combined Saphenous nerve block and Obturator nerve block with local infiltration analgesia in the tissue around the knee after total kneearthroplasty. In the combined nerve blocks we use a mixture of Ropivacaine and Adrenaline combined with high dose systemic dexamethasone and Ketorolac and the mixture for local infiltration consist of Ropivacaine, Adrenaline and Ketoroloc. The investigators hypothesis is that the combined nerve blocks reduces pain and reduces the opioid consumption and thus reduce side effects such as nausea, vomiting and lethargy compared to the current treatment with local infiltration analgesia.~Background:~Nerve blocks as analgesic treatment after orthopedic surgery is a recognized and proven procedure. The nerve blocks have the disadvantage that not only do they anesthetize the sensory nerve fibers but also the nerve fibers to the muscles of the leg. The Saphenous nerve block causes only stunning of sensory nerves to the knee region. The Obturator nerve block causes both stunning of the sensory nerves to the knee region and the thighs inward leading muscles, and does not affect the patient's mobilization capacity.~Both blocks are known to be a good addition to the analgesic treatment. Ropivacaine is a well-known local anesthetic. Adrenaline have also been used in other studies, in addition to the local anesthetic agent, and has been shown to prolong the effect of the nerve block. Saphenous and Obturator nerve block with all four drugs Ropivacaine and Adrenaline combined with high dose systemic Dexamethasone has not been systematically investigated in knee replacement surgery, and it is not known whether this method will provide better pain treatment.~Method~The patient can receive one of two treatments, determined randomly:~A. Saphenous and Obturator nerve block with active anesthetics (Ropivacaine, Adrenaline) combined with systemic ketoroloc and high dose Dexamethasone and local infiltration around the knee joint with placebo medicine (normal saline).~B. Both blocks with placebo medicine (normal saline) and local infiltration around the knee joint with activ local anesthetic.~Neither patient, investigator or staff around the patient will have knowledge of which treatment the patient has received.~The blocks will be placed before the operation and local infiltration around the knee joint will be given by the surgeon during the operation.", - "NCTID": "NCT02374008" - }, - { - "brief_title": "ESWT as a Treatment for Chronic NHO in TBI Patients", - "phase": "", - "drugs": "['ESWT - Extracorporeal Shockwave Therapy']", - "drugs_list": [ - "ESWT - Extracorporeal Shockwave Therapy" - ], - "diseases": "['TBI Traumatic Brain Injury']", - "diseases_list": [ - "TBI Traumatic Brain Injury" - ], - "enrollment": "12.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 18 years \n\n Brain injured patients with a diagnosis of NHO around the hip and/ or knee for a period of greater than one year. \n\n Patients who are able, or legal guardians who are willing, to provide informed consent after both oral and written information. \n\n ", - "exclusion_criteria": ": \n\n Pregnancy. \n\n Rheumatoid arthritis, ankylosing spondylitis, or femoral neck fractures \n\n Elevated serum alkaline phosphatase (SAP) levels and/or evidence of active bone remodelling in bone scan", - "brief_summary": "Effect of Extracorporeal Shock Wave Therapy on Chronic Neurogenic Heterotopic Ossification in Traumatic Brain Injured (TBI) patients~Chronic Neurogenic Heterotopic Ossification (NHO) - Heterotopic ossification is a well known late complication of traumatic brain injury. Extracorporeal Shock Wave Therapy - ESWT- is used in various medical situations and is being tested for feasibility of use in TBI patients.", - "NCTID": "NCT02331628" - }, - { - "brief_title": "Protracted Effect of Combined Nerve Blocks After Total Knee Arthroplasty", - "phase": "Phase 4", - "drugs": "['Dexamethasone 4 mg + Clonidine 75 microgram + Marcaine 90 mg + Adrenaline 90 microgram', 'Dexamethasone 2 mg + Clonidine 37,5 microgram + Marcaine 45 mg + Adrenaline 45 microgram', 'Ropivacaine + Toradol + Adrenaline']", - "drugs_list": [ - "Dexamethasone 4 mg + Clonidine 75 microgram + Marcaine 90 mg + Adrenaline 90 microgram", - "Dexamethasone 2 mg + Clonidine 37,5 microgram + Marcaine 45 mg + Adrenaline 45 microgram", - "Ropivacaine + Toradol + Adrenaline" - ], - "diseases": "['Pain', 'Total Knee Arthroplasty', 'Nerve Blocks']", - "diseases_list": [ - "Pain", - "Total Knee Arthroplasty", - "Nerve Blocks" - ], - "enrollment": "75.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 50 years \n\n Patients set to cemented Total knee arthroplasty in spinal block \n\n Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations fully \n\n Illness score 1-3 \n\n ", - "exclusion_criteria": ": \n\n Patients who can not cooperate with the investigation \n\n Patients who do not understand or speak Danish \n\n Patients receiving immunosuppressive therapy \n\n Patients with a treatment-dependent diabetes mellitus \n\n Patients with known neuropathy in the lower limbs \n\n Allergy to those drugs used in the study \n\n Alcohol and / or drug abuse - the investigator's opinion \n\n Patients who can not tolerate Non steroid analgesic drugs \n\n Use of strong opioid several times a day (morphine, ketogan, Oxynorm, methadone, fentanyl)", - "brief_summary": "Purpose:~The purpose of this study is to evaluate the postoperative analgesic effect of a combined Saphenous nerve block and Obturator nerve block with local infiltration analgesia in the tissue around the knee after surgery with knee replacement. In the combined nerve blocks we use a mixture of Bupivacaine, Adrenaline, Clonidine and Dexamethasone (protracted mixture) and the local infiltration consist of Ropivacaine, Adrenaline and Toradol. Our hypothesis is that the combined nerve blocks with protracted mixture prolongs block duration, reduces pain and reduces the need for morphine and thus reduce side effects such as nausea, vomiting and lethargy compared to the current treatment with local infiltration analgesia.~Background:~Nerve blocks as analgesic treatment after orthopedic surgery is a recognized and proven procedure. The nerve blocks have the disadvantage that not only do they anesthetize the sensory nerve fibers but also the nerve fibers to the muscles of the leg. The Saphenous nerve block causes only stunning of sensory nerves to the knee region. The Obturator nerve block causes both stunning of the sensory nerves to the knee region and the thighs inward leading muscles, and does not affect the patient's mobilization capacity.~Both blocks are known to be a good addition to the analgesic treatment. Bupivacaine is a well-known local anesthetic. Adrenaline, Clonidine and Dexamethasone have also been used in other studies, in addition to the local anesthetic agent, and has been shown to prolong the effect of the nerve block. Saphenous and Obturator nerve block with all four drugs Bupivacaine, Adrenaline, Clonidine and Dexamethasone has not been systematically investigated in knee replacement surgery, and it is not known whether this method will provide better pain treatment.~Method~The patient can receive one of three treatments, determined randomly:~A. Saphenous and Obturator nerve block with active anesthetics (Bupivacaine, Adrenaline, Clonidine, Dexamethasone) and local block around the knee joint with placebo medicine (normal saline).~B. Saphenous block with active anesthetics and both Obturator nerve block and local block around the knee joint with placebo medicine (normal saline).~C. Both block with placebo medicine (normal saline) and local block around the knee joint with effective local anesthetic.~Neither patient, investigator or staff around the patient will have knowledge of which treatment the patient has received.~The blocks will be injected before the operation and local infiltration around the knee joint will be given by the surgeon during the operation.", - "NCTID": "NCT02067078" - }, - { - "brief_title": "Arthrocentesis Study", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Periprosthetic Joint Infection', 'Septic Arthritis']", - "diseases_list": [ - "Periprosthetic Joint Infection", - "Septic Arthritis" - ], - "enrollment": "400.0", - "inclusion_criteria": "inclusion criteria: \n\n adult of 18 or more years \n\n written consent to participate in study \n\n suspicion of septic arthritis or periprosthetic joint infection \n\n joint aspirate minimum of 5 ml \n\n ", - "exclusion_criteria": ": \n\n is not able to understand the aim or purpose of this study \n\n empty joint aspirate", - "brief_summary": "The purpose of this study is to analyze pre- and intra-operative joint aspirates of native joints and joints with suspicion of periprosthetic joint infection (PJI) of the hip, knee and shoulder acquired in clinical routine. Joint aspirates are then analyzed with new diagnostic methods (microcalorimetry, PCR, alpha-defensin, etc.). Diagnostic speed and accuracy of these methods is compared to standard diagnostic methods in clinical routine, such as blood cultures of joint aspirates, cell count/differential, intra-operative tissue culture and histology and sonication.", - "NCTID": "NCT02530229" - }, - { - "brief_title": "Minimally Invasive Total Knee Replacement - Navigated Versus Non-navigated Study", - "phase": "Phase 4", - "drugs": "['Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique', 'Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigation']", - "drugs_list": [ - "Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique", - "Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigation" - ], - "diseases": "['Osteoarthritis']", - "diseases_list": [ - "Osteoarthritis" - ], - "enrollment": "86.0", - "inclusion_criteria": "inclusion criteria: \n\n Male or female subjects aged between 18 and 80 years inclusive. \n\n Subjects who require a primary total knee replacement and are considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol. \n\n Subjects who are able to give and have given voluntary, written informed consent to participate in this clinical investigation. \n\n Subjects who have given consent to the transfer of his/her information to DePuy. \n\n Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. \n\n ", - "exclusion_criteria": ": \n\n Subjects who have a pre-operative limb deformity of equal to or greater than 10\u00b0 varus or 15\u00b0 valgus as defined using the anatomical axis. \n\n Subjects who have a fixed flexion contracture of greater than 10\u00ba. \n\n Subjects who are clinically obese i.e. BMI \u226530. \n\n Subjects who have, in the opinion of the Investigator, an existing condition that would compromise their participation and follow-up in this study. \n\n Female subjects who are pregnant or lactating. \n\n Subjects who are known drug or alcohol abusers or have a psychological disorder that could affect follow-up care or treatment outcomes. \n\n Subjects who have participated in a clinical investigation with an investigational product in the last 3 months. \n\n Subjects currently involved in any personal injury litigation, medical-legal or worker's compensations claims. \n\n Subjects who have previously had a prosthetic knee replacement device (any type) of the affected knee. \n\n Subjects who present with ankylosis of the hip joint on the side to be treated or previous ipsilateral Upper Tibial Osteotomy/High Tibial Osteotomy. \n\n Subjects who require simultaneous bilateral total knee replacements. \n\n Subjects who have had a contralateral TKA performed less than six months before the proposed TKA. \n\n Subjects who have had a contralateral TKA and that knee was previously entered in the study. \n\n Subjects who, in the opinion of the surgeon, will require a contralateral TKA within 6 months of the index procedure. \n\n Subjects in whom the surgeon intends to implant a knee component that is not one of those listed in Table 1. \n\n Subjects who have inflammatory arthritis.", - "brief_summary": "The primary objective of this investigation is to compare the precision of long leg alignment achieved by the two types of procedure. The secondary objectives of this investigation are to:~Compare the accuracy of long leg alignment achieved by the two types of procedure.~Compare the number of optimal implantations achieved by the two types of procedure.~Compare the clinical performance of the knee replacement in subjects who have undergone one of the two types of procedure.~Compare the functional outcome achieved by subjects who have undergone one of the two types of procedure.~Compare the interface radiographic appearance 5 years post-operatively between the two types of procedure.~Compare the accuracy and precision of long leg alignment achieved by the two types of procedure 5 years post-operatively, i.e., at final follow-up and also the change in accuracy and precision between the final follow-up and baseline.~Compare the Adverse Events experienced by the subjects who have undergone the two types of procedure.", - "NCTID": "NCT00733330" - }, - { - "brief_title": "Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma", - "phase": "Phase 2", - "drugs": "['humanized anti-GD2 antibody', 'GM-CSF']", - "drugs_list": [ - "humanized anti-GD2 antibody", - "GM-CSF" - ], - "diseases": "['Recurrent Osteosarcoma']", - "diseases_list": [ - "Recurrent Osteosarcoma" - ], - "enrollment": "46.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients must have recurrent OS. OS must be verified by histopathology review by the site's Department of Pathology. (Patients registered at MSK must have pathology confirmed by MSK Department of Pathology.) \n\n Patients must be in a \u22652nd complete remission as indicated by appropriate radiologic evaluations at the time of study entry. \n\n Patients must be \u2265 1 year of age and \u2264 to 40 years of age at the time of enrollment. \n\n Prior therapy: \u22653 weeks should have elapsed since last cytotoxic therapy, immunotherapy or radiation therapy. More than one week should have elapsed since major surgery. \n\n NOTE: Minor surgery (e.g. minor biopsy, central venous catheter placement, shunt revision) is permitted within 1 week prior to enrollment) \n\n Adequate hematopoietic function defined as: \n\n Absolute neutrophil count \u2265 500/ul \n\n Absolute lymphocyte count \u2265 500/ul \n\n Platelet count \u2265 50,000/ul (transfusion independent) \n\n Adequate hepatic function as defined by: \n\n Total bilirubin of \u2264 1.5 times upper limit of normal (exception is made for patients with Gilbert's syndrome who may be considered eligible if total bilirubin is \u2264 3 times upper limit of normal). \n\n AST (SGOT) of \u2264 3 times upper limit of normal \n\n ALT (SGPT) of \u2264 3 times upper limit of normal \n\n Adequate renal function as defined by a serum creatinine of \u2264 1.5 times upper limit of normal \n\n Adequate cardiac function as defined by a shortening fraction of \u2265 28% or an ejection fraction \u2265 50% \n\n Adequate pulmonary function as defined by no evidence of dyspnea at rest at no history of exercise intolerance \n\n Adequate performance status as defined by ECOG score of \u2264 2 or Karnofsky/Lansky score \u2265 50% \n\n Prior treatment with other anti-GD2 antibodies is allowed (prior treatment with Hu3F8 is NOT allowed), but HAHA antibody titer must be negative \n\n Women of child-bearing potential must be willing to practice an effective method of birth control while on treatment \n\n Signed informed consent indicating awareness of the investigational nature of this program \n\n ", - "exclusion_criteria": ": \n\n Patients with OS in first complete remission. \n\n Presence of overt metastatic disease at any site. \n\n Active life-threatening infection. \n\n Pregnant women or women who are breast-feeding. \n\n Inability to comply with protocol requirements.", - "brief_summary": "The purpose of this study is to find out what effect an antibody called Humanized 3F8 (Hu3F8) and a drug called GM-CSF have on the patient and whether it can keep the patient in remission longer and/or prevent recurrence of the disease.", - "NCTID": "NCT02502786" - }, - { - "brief_title": "Optimizing Local Anesthetic Concentration for Continuous Femoral Nerve Blocks", - "phase": "Phase 4", - "drugs": "['0.1% and 0.4% perineural ropivicaine']", - "drugs_list": [ - "0.1% and 0.4% perineural ropivicaine" - ], - "diseases": "['Total Knee Arthroplasty', 'Knee Pain']", - "diseases_list": [ - "Total Knee Arthroplasty", - "Knee Pain" - ], - "enrollment": "48.0", - "inclusion_criteria": "inclusion criteria: \n\n Primary, bilateral TKA \n\n Age 18 years or older \n\n Postoperative analgesic pain includes bilateral continuous femoral nerve blocks \n\n ", - "exclusion_criteria": ": \n\n Chronic, high-dose opioid use \n\n History of opioid abuse \n\n Any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles \n\n Pregnancy \n\n Incarceration", - "brief_summary": "This is a randomized, observer-masked, controlled study. Subjects will be patients undergoing bilateral total knee arthroplasty (TKA). One side (left or right) will be randomized to one of two treatment groups: a postoperative ropivacaine concentration of 0.1% or 0.4%. The contralateral side will receive the other possible ropivacaine concentration of 0.1% or 0.4%. The basal rate and patient-controlled bolus volume will depend upon the treatment group, but the total dose of local anesthetic is the same for each. For the duration of the study, all patients will receive the current usual and customary analgesics for bilateral TKA patients. All patients will receive a ropivacaine perineural infusions initiated in the operating room and continued until at least the afternoon of postoperative day (POD) 2, as well as oral acetaminophen, a sustained-release oral opioid; and celecoxib. Rescue opioid and route of administration will be determined by pain severity using a Numeric Rating Scale of 0-10, with 0 equal to no pain and 10 being the worst imaginable pain.", - "NCTID": "NCT00923598" - }, - { - "brief_title": "Intra-articular Hyaluronan After Arthroscopic Meniscal Surgery", - "phase": "", - "drugs": "['Hyaluronan (0.5%, 5 mg/10 ml)', 'Standard arthroscopic meniscal surgery']", - "drugs_list": [ - "Hyaluronan (0.5%", - "5 mg/10 ml)", - "Standard arthroscopic meniscal surgery" - ], - "diseases": "['Arthroscopic Meniscal Surgery']", - "diseases_list": [ - "Arthroscopic Meniscal Surgery" - ], - "enrollment": "64.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female patients between 18 and 75 years of age. \n\n Good general health condition. \n\n Signed written informed consent. \n\n Patients with necessity for arthroscopic meniscal surgery. \n\n Ensured compliance of subject over the whole study period. \n\n ", - "exclusion_criteria": ": \n\n Concomitant or previous participation in a clinical investigation within the last 3 months prior to study inclusion. \n\n Knee joint arthroscopy in study relevant joint within 6 months prior to study inclusion. \n\n Patients with known hypersensitivity to the investigational device (i.e. active compound and excipients) or any component or procedure used in the study. \n\n Contraindication for the use of the investigational product or for the scheduled arthroscopy, used anesthesia and post-surgical treatment. \n\n Concomitant disease of sufficient severity (e.g. uncontrolled diabetes mellitus, carcinoma, etc.), which in the opinion of the investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study. \n\n Concomitant disease of sufficient severity at study relevant joint (e.g. known or suspected infection, peripheral neuropathy or presence of hemarthros). \n\n List of concomitant medications not allowed which interfere with the functional assessments of this study. \n\n Use of medication contraindicated for arthroscopic surgery. \n\n Intra-articular treatment with a sodium hyaluronate-based product within the last 6 months or use of corticosteroid containing substance within the last 3 months at study relevant joint. \n\n Recent history of drug and/or alcohol abuse (within the last 6 months) or patients with severe mental illness or suicidal tendency. \n\n Pregnant or lactating females. \n\n Participants of childbearing age (pre-menopausal) who do not accept the use of methods of birth control with pearl index \u2264 1% (i.e. oral contraceptives, vaginal ring, hormone-releasing Intrauterine Device (IUD), implants, depot syringes, hormone patch, double barrier method, tubal ligation, vasectomised partner,\u2026) during the treatment period and the first 4 weeks of follow-up period. \n\n Subjects having a high probability of non-compliance to the study procedures according to investigator's judgement (like illiteracy, insufficient knowledge of local language). \n\n Kellgren III-IV on study relevant side (confirmed by X-ray).", - "brief_summary": "The primary objective of this clinical investigation is to determine whether post-arthroscopic treatment with 10 ml of 0.5% sodium hyaluronate (VISCOSEAL\u00ae SYRINGE) can relief pain, improve mobility and promote joint recovery, compared to the standard arthroscopy procedure alone, in patients undergoing arthroscopic procedure.", - "NCTID": "NCT01482624" - }, - { - "brief_title": "Prevena\u2122 Incision Management System Over Primarily Closed Hip and Knee Incisions in Patients Immediately Post Total Hip and Knee Arthroplasty", - "phase": "Phase 4", - "drugs": "['Prevena Incisional Management System']", - "drugs_list": [ - "Prevena Incisional Management System" - ], - "diseases": "['Linear or Emi-linear Incisions', 'Total Hip Arthroplasty', 'Total Knee Arthroplasty']", - "diseases_list": [ - "Linear or Emi-linear Incisions", - "Total Hip Arthroplasty", - "Total Knee Arthroplasty" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject must be \u2265 18 years of age \n\n Subject must, at the treating physician's determination and definition, be an appropriate Candidate for primary total hip or knee arthroplasty \n\n Subjects who undergo primary total knee or hip arthroplasty must have a linear or semi-linear incision whose length and curvature should fit within the dimensions bound by the polyurethane foam (10 inches in length by 2.5 inches in width) \n\n Subject is able and willing to provide written informed consent and comply with visit schedule \n\n Subject must agree to avoid application of tanning lotions or exposure of ultraviolet radiation from sun or artificial sources such as a tanning bed on operative area for the duration of study participation \n\n Subject must not be pregnant if of child-bearing potential, or otherwise must be surgically sterilized or unable to conceive. All females, regardless of child-bearing potential, will receive a urine hCG test 2 weeks prior to surgery and the test result must be negative for pregnancy. \n\n Subjects who are of child-bearing potential must be utilizing an acceptable method of birth control (eg, birth control pills, condom with spermicide, diaphragm with spermicide, implants, IUD, injections, vaginal rings, hormonal skin patch, etc) and be willing to continue birth control for duration of study participation. If birth control method is the form of birth control pills, shots, implants skin patches, or IUD, the method must have been utilized for at least 30 days prior to study participation. \n\n Subject must be willing to wear loose fitting clothing for duration of treatment period \n\n Subject must be willing to comply with visit schedule for the duration of the study \n\n ", - "exclusion_criteria": ": \n\n Positive pregnancy test confirmed by hCG in urine \n\n Current or past (30 days prior to surgery) within time of screening attempts to become pregnant \n\n Current local or systemic infection (eg, skin infections, sinus infections, urinary tract infection, sepsis, etc) \n\n Current or past (14 days prior to surgery) within time of screening topical treatments on operative area (eg, laser hair or tattoo removal, sunless tanning lotions) \n\n Current or past (14 days prior to surgery) steroid topical therapies on operative area \n\n Current or past (30 days prior to surgery) use of oral steroids (NOTE: Use of non-topical, ophthalmic or aerosol types of steroids (ie, inhaled corticosteroids) are permitted at screening and throughout the clinical trial) \n\n Current or past (72 hours prior to surgery) within surgery use of antihistamines \n\n Current or past (30 days prior to surgery) within time of screening use of oral Tetracycline or AcutaneTM or topical Tetracycline or AcutaneTM on the operative area \n\n Presence of skin lesions or abnormalities on operative area \n\n Current or past malignancy requiring immunosuppressant therapy or chemotherapy within 5 years within time of screening \n\n Presence of excessive skin folds on operative area \n\n Intentional exposure of the operative area to ultraviolet radiation (14 days prior to surgery) within time of screening (ie, sunbathing or tanning bed) \n\n Presence of sunburned or peeling skin on operative area \n\n Tattoos on operative area \n\n Presence of severe, raised scar tissue on operative area which may interfere with pre and post skin evaluation assessments \n\n Presence of an open wound prior to the index surgical procedure on operative area \n\n Reported alcohol (\u2265 3 drinks per day) or drug abuse within the past 6 months \n\n Topical hypersensitivity or allergy to any disposable components of the dressing system (eg, silver, polyurethane, polyester, or acrylic adhesive) \n\n Topical hypersensitivity or allergy towards any medical adhesive \n\n Current enrollment or past participation in this clinical study or any other study within \u226430 days \n\n Any systemic or local active dermatological disease that might interfere with the evaluation of the operative area (eg, Meleney's ulcer, scleroderma, chronic urticaria, psoriasis, skin cancer, eczema, seborrhea, or malignancy) \n\n Connective tissue disease or collagen vascular disease (eg, Ehlers-Danlos syndrome, systemic lupus erythematosus, rheumatoid arthritis) \n\n Current or history of hematological disorders or conditions (eg, polycythemia vera, thrombocythemia, sickle-cell disease) \n\n Any Subject with conditions which can potentially result in abnormally pigmented skin (eg, melasma, vitiligo, pityriasis versicolor) \n\n Inability or refusal to wear loose fitting clothing for the duration of the treatment period \n\n Subjects in whom orthopaedic reconstruction is required in addition to total hip or knee arthroplasty \n\n Subjects who are having the total hip or knee arthroplasty as a result of acute orthopaedic trauma \n\n Subjects who have incurred acute orthopaedic trauma (ie, hip fracture) recently or at any time \n\n Subjects who have either acute or chronic open/active wounds present (including biopsies, ulcerations, etc) \n\n Subjects in whom the index procedure is a revision of a total hip or knee arthroplasty \n\n Subjects in whom the primary or partial total hip or knee arthroplasty would also be performed on the contra lateral knee or hip at the same time", - "brief_summary": "The intent of this study is to evaluate the Prevena \u2122 125 Unit and dressing system, when applied to either the hip or knee area over a surgical cut for the time you are hospitalized.", - "NCTID": "NCT01380665" - }, - { - "brief_title": "Trastuzumab in Treating Patients With Recurrent Osteosarcoma", - "phase": "Phase 2", - "drugs": "['trastuzumab', 'conventional surgery']", - "drugs_list": [ - "trastuzumab", - "conventional surgery" - ], - "diseases": "['Sarcoma']", - "diseases_list": [ - "Sarcoma" - ], - "enrollment": "", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Histologically confirmed recurrent osteosarcoma after initial systemic therapy with doxorubicin \n\n Measurable disease \n\n Immunohistochemical evidence of 2+ overexpression of HER2 \n\n PATIENT CHARACTERISTICS: \n\n Age: \n\n Any age \n\n Performance status: \n\n Karnofsky 80-100% \n\n Life expectancy: \n\n Not specified \n\n Hematopoietic: \n\n Not specified \n\n Hepatic: \n\n ALT or AST less than 3 times upper limit of normal (ULN) \n\n Bilirubin less than 1.5 times ULN \n\n Renal: \n\n Creatinine less than 1.5 times ULN OR \n\n Creatinine clearance greater than 60 mL/min \n\n Cardiovascular: \n\n Fractional shortening at least 29% by echocardiogram OR \n\n Ejection fraction at least 50% by MUGA \n\n No prior cardiac dysfunction, even if presently controlled \n\n Other: \n\n Not pregnant or nursing \n\n Negative pregnancy test \n\n Fertile patients must use effective contraception \n\n PRIOR CONCURRENT THERAPY: \n\n Biologic therapy: \n\n Not specified \n\n Chemotherapy: \n\n See Disease Characteristics \n\n At least 4 weeks since prior chemotherapy \n\n No prior anthracycline more than 450 mg/m^2 \n\n Endocrine therapy: \n\n Not specified \n\n Radiotherapy: \n\n Not specified \n\n Surgery: \n\n Not specified \n\n Other: \n\n No other concurrent cancer therapy", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.~PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who have recurrent osteosarcoma.", - "NCTID": "NCT00005033" - }, - { - "brief_title": "Adjuvant High-Dose Thiotepa and Stem Cell Rescue Associated With Conventional Chemotherapy in Relapsed Osteosarcoma", - "phase": "Phase 2", - "drugs": "['Thiotepa']", - "drugs_list": [ - "Thiotepa" - ], - "diseases": "['Osteosarcoma']", - "diseases_list": [ - "Osteosarcoma" - ], - "enrollment": "44.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 1 year and < 50 years \n\n First osteosarcoma relapse, either local or metastatic, or second relapse after exclusive surgery NB: Whenever possible, only patients with histological evidence of relapse will be included. \n\n Indication for chemotherapy confirmed by a multidisciplinary committee. \n\n Surgical resection of all tumor sites must be possible, either as first-line therapy or after chemotherapy. \n\n Lansky score \u2265 60%, or ECOG Performance Status \u2264 2 \n\n \u2265 21-day interval after first-line chemotherapy \n\n Blood tests, renal and liver functions within the normal range for age with, in particular, 7 days prior to study entry, blood or serum values as follows: \n\n blood: neutrophil count > 1 G/L; platelets >100 G/L \n\n renal: serum creatinine \u2264 1.5 x ULN depending on age; patients with serum creatinine values > 1.5 x ULN are eligible if creatinine clearance is > 70 mL/min/1.73 m\u00b2 \n\n liver: total bilirubin < 2 x ULN; ASAT and ALAT \u2264 5 x ULN \n\n cardiac: isotopic or echographic Left Ventricular Ejection Fraction > 50 %. \n\n Signed written informed consent; for children, signed consent from the patient (depending on age) and from the parents or legal representative is mandatory \n\n Documented negative serum \u03b2HCG for female patients of childbearing age \n\n Affiliation with health insurance. \n\n ", - "exclusion_criteria": ": \n\n Patients with multiple relapses for whom surgical resection seems impossible, even after chemotherapy. \n\n Patients already treated with high-dose chemotherapy regimens \n\n Patients with a contra-indication to the treatment proposed \n\n Patients not eligible for leukapheresis \n\n Two-year follow-up impossible due to social, family, geographic or psychological reasons \n\n Patient included in another protocol of clinical research \n\n Pregnant or lactating women.", - "brief_summary": "Approximately 150 new cases of osteosarcoma are reported each year in France, of which 15 to 20% are metastatic.~Further to the initial standard care, about 45% of the patients relapse within a median duration of 20 months.~Result of the OS94 study results and of the investigation performed within the CRLCC, indicate that 25 to 30 patients (children and adults) experience an osteosarcoma relapse each year in FRANCE.~According to several studies, the 5-year overall survival rate of patients in first relapse is 23-28%,with a median post relapse survival of 10 to 17 months. Multiple relapse cases are also reported in the COSS study, with a median time to second relapse of 0.8 year.~At present, there is no reference treatment for the standard care of osteosarcoma relapse in FRANCE.~Thiotepa is known for its antitumor effect in numerous malignant tumors. In 2007, a study from our institution reported that about 35% of all osteosarcoma relapses are treated with a high-dose thiotepa while the efficacy and tolerance of this therapeutic strategy have never been assessed.~These results highlight the need to the evaluate the efficacy and tolerance of this high-dose of thiotepa within a clinical trial and its inclusion in the standard care of the osteosarcoma at relapse.", - "NCTID": "NCT00978471" - }, - { - "brief_title": "Adult Dengue Platelet Study", - "phase": "", - "drugs": "['Platelet transfusion', 'Supportive care']", - "drugs_list": [ - "Platelet transfusion", - "Supportive care" - ], - "diseases": "['Dengue Fever']", - "diseases_list": [ - "Dengue Fever" - ], - "enrollment": "372.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 21years \n\n Probable or confirmed dengue \n\n a) Confirmed dengue: laboratory confirmation of acute dengue by either i) positive polymerase chain reaction (PCR) for viral ribonucleic acid (RNA), or ii)positive NS1 antigen test with a compatible clinical syndrome b) Probable dengue: Positive acute dengue serology and clinical presentation fulfilling either WHO 1997 or 2009 criteria for probable dengue. \n\n i) 1997 criteria: Acute febrile illness and two or more of the following: \n\n headache, \n\n retro-orbital pain, \n\n myalgia, \n\n arthralgia, \n\n rash, \n\n hemorrhagic manifestations, \n\n leucopoenia ii) 2009 criteria: Fever and two of the following: \n\n nausea/vomiting, \n\n rash, \n\n aches/pains, \n\n positive tourniquet test, \n\n leucopoenia, \n\n one or more warning sign \n\n abdominal pain/tenderness, \n\n persistent vomiting, \n\n clinical fluid accumulation, \n\n mucosal bleed, \n\n lethargy/restlessness, \n\n liver enlargement >2cm, \n\n increase in haematocrit concurrent with rapid decrease in platelet count \n\n Platelets \u2264 20x103/\u03bcL", - "exclusion_criteria": "", - "brief_summary": "Retrospective data in children with dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS), and in adults with dengue fever (DF), suggested a lack of benefit from prophylactic platelet transfusion for severe thrombocytopenia in dengue patients without bleeding. However, in Taiwan and Singapore, platelet transfusion was given to 13-50% of hospitalised dengue patients. This is a prospective randomised study to examine the safety and efficacy of prophylactic platelet transfusion in adults with dengue and severe thrombocytopenia without bleeding.~The hypotheses are:~Prophylactic platelet transfusion is safe in hospitalised dengue patients with severe thrombocytopenia.~Prophylactic platelet transfusion is effective in preventing bleeding in hospitalised dengue patients with severe thrombocytopenia.", - "NCTID": "NCT01030211" - }, - { - "brief_title": "ARIXTRA Local Study For Registration In China.", - "phase": "Phase 3", - "drugs": "['ARIXTRA infusion', 'Enoxaparine infusion']", - "drugs_list": [ - "ARIXTRA infusion", - "Enoxaparine infusion" - ], - "diseases": "['Thromboembolism', 'Knee Replacement', 'Hip Replacement']", - "diseases_list": [ - "Thromboembolism", - "Knee Replacement", - "Hip Replacement" - ], - "enrollment": "240.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients undergoing either an elective major hip or knee replacement or revision. \n\n Signed written informed consent. Men or women of non-child bearing potential(i.e., post menopausal or with hysterectomy of bilateral tubule ligation) or women of childbearing potential without any plan to have a child. \n\n ", - "exclusion_criteria": ": \n\n History of serious active bleeding in last 3 month \n\n Concurrent or history of thrombocytopenia ( Platelet< 100x109/L) \n\n History of hypersensitivity reaction to heparin, Low molecular weight heparin or pork product \n\n Acute bacterial endocarditis \n\n Congenital or acquired bleeding disease in last 3 months \n\n Concurrent uncontrolled ulcer or gastrointestinal disease with blood vessel dysplasia \n\n Concurrent hemorrhagic cerebrovascular disease or surgical history in cerebral, spine or eye \n\n Conditions need to leave a tubule in intradural or extradural \n\n Contraindication to anticoagulant or condition required to take long term oral anticoagulant \n\n Abnormality in hepatic (>1.5x UNL), renal (Clcr < 30ml/min) or cardiac function, uncontrolled hypertension or tumor Concurrent disorder of blood vessel in lower limb \n\n Positive result in Human Chorionic Gonadotropin test Participated in any other investigational study on Deep Vein Thrombosis prevention in last 90 days. \n\n Concurrently to have hip and knee or double hip/knee replacement at the same time", - "brief_summary": "This is a local registration study in China to compare the safety and efficacy of ARIXTRA to Enoxaparine in patients undergoing elective major hip or knee replacement or a revision of components.", - "NCTID": "NCT00328939" - }, - { - "brief_title": "iC9-GD2-CAR-VZV-CTLs/Refractory or Metastatic GD2-positive Sarcoma and Neuroblastoma", - "phase": "Phase 1", - "drugs": "['GD2 T cells', 'VZV vaccine', 'Fludarabine', 'Cyclophosphamide']", - "drugs_list": [ - "GD2 T cells", - "VZV vaccine", - "Fludarabine", - "Cyclophosphamide" - ], - "diseases": "['Osteosarcoma', 'Neuroblastoma']", - "diseases_list": [ - "Osteosarcoma", - "Neuroblastoma" - ], - "enrollment": "26.0", - "inclusion_criteria": "inclusion criteria: \n\n Procurement: \n\n Diagnosis of relapsed or refractory osteosarcoma OR relapsed or refractory high risk neuroblastoma not responsive to standard treatment. \n\n Either previously infected with varicella zoster virus(VZV; chicken pox) or previously vaccinated with VZV vaccine \n\n Karnofsky/Lansky score of greater than or equal to 50 \n\n Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent \n\n Treatment: \n\n Diagnosis of relapsed or refractory osteosarcoma OR relapsed or refractory high risk neuroblastoma not responsive to standard treatment. \n\n Recovered from the acute toxic effects of all prior chemotherapy \n\n Karnofsky/Lansky score of greater than or equal to 50 \n\n Bilirubin less than or equal to 3x upper limit of normal, AST less than or equal to 5x upper limit of normal, Serum creatinine less than or equal to 2x upper limit of normal, Hgb greater than or equal to 7.0 g/dl, ANC>500/uL, platelets > 50,000/uL \n\n Pulse oximetry of greater than or equal to 90% on room air \n\n Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the CTL infusion. Male partner should use a condom. \n\n Available autologous transduced cytotoxic T lymphocytes with greater than or equal to 20% expression of GD2 CAR and killing of GD2-positive targets greater than or equal to 20% in cytotoxicity assay \n\n Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent \n\n ", - "exclusion_criteria": ": \n\n Procurement: \n\n \u2022 Known primary immune deficiency or HIV positivity \n\n Treatment: \n\n Severe intercurrent infection \n\n Known primary immune deficiency or HIV positivity \n\n Pregnant or lactating \n\n History of hypersensitivity reactions to murine protein-containing products \n\n Known allergy to VZV vaccine", - "brief_summary": "The purpose of this study is to find the largest safe dose of GD2-T cells (also called iC9-GD2-CAR-VZV-CTLs) in combination with a varicella zoster vaccine and lymohodepleting chemotherapy. Additionally, we will learn what the side effects of this treatment are and to see whether this therapy might help patients with advanced osteosarcoma and neuroblastoma. Because there is no standard treatment for recurrent/refractory osteosarcoma and neuroblastoma at this time or because the currently used treatments do not work fully in all cases, patients are being asked to volunteer to take part in a gene transfer research study using special immune cells.~The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients.~Investigators have found from previous research that a new gene can be put into T cells that will make them recognize cancer cells and kill them. Investigators now want to see if a new gene can be put in these cells that will let the T cells recognize and kill sarcoma and neuroblastoma cells. The new gene is called a chimeric antigen receptor (CAR) and consists of an antibody called 14g2a that recognizes GD2, a protein that is found on sarcoma and neuroblastoma cells (GD2-CAR). In addition, it contains parts of the CD28 and OX40 genes which can stimulate T cells to make them live longer.~Investigators have found that CAR-T cells can kill some of the tumor, but they don't last very long in the body and so the tumor eventually comes back. T cells that recognize the virus that causes chicken pox, varicella zoster virus (VZV), remain in the bloodstream for many years especially if they are stimulated or boosted by the VZV vaccine. Investigators will therefore insert the GD2-CAR gene into T cells that recognize VZV. These cells are called iC9-GD2-CAR-VZV-specific T cells but are referred to as GD2-T cells for simplicity.", - "NCTID": "NCT01953900" - }, - { - "brief_title": "Lower Leg Edema Evaluation After Total Knee Arthroplasty Using Bioimpedance", - "phase": "", - "drugs": "['bioimpedance spectroscopy ImpediMed SFB7 Brisbane Australia']", - "drugs_list": [ - "bioimpedance spectroscopy ImpediMed SFB7 Brisbane Australia" - ], - "diseases": "['Edema']", - "diseases_list": [ - "Edema" - ], - "enrollment": "34.0", - "inclusion_criteria": "inclusion criteria: \n\n knee replacement surgery \n\n ", - "exclusion_criteria": ": \n\n pacemaker \n\n cardiac defibrillator \n\n other metallic implant than knee arthroplasty", - "brief_summary": "The purpose of this study is to evaluate the applicability and measurement properties of bioimpedance spectroscopy for postsurgical edema assessment after total knee arthroplasty", - "NCTID": "NCT00627770" - }, - { - "brief_title": "Magnetic Resonance (MR) Spectroscopy In Familial Mediterranean Fever (FMF) Patients", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Familial Mediterranean Fever']", - "diseases_list": [ - "Familial Mediterranean Fever" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Fulfilling the Tel Hashomer criteria for the diagnosis of FMF [5]. \n\n Suffering from episodes of exertional leg pain and or exertional ankle edema \n\n 18-45 years old \n\n On a stable (\u2265 2 weeks) dose of oral colchicine therapy \n\n Non-smokers \n\n ", - "exclusion_criteria": ": \n\n with known peripheral vascular disease (PVD) and/or multiple risk factors for PVD (such as diabetes, hypertension, hyperlipidemia) \n\n Suffering from muscular or neurological diseases not related to FMF \n\n With elevated serum creatinine / liver enzymes/ creatine phosphokinase (CPK) levels. \n\n Suffering from claustrophobia, or with metal fragments in body tissue, or with other contraindications for MRI.", - "brief_summary": "Familial Mediterranean fever (FMF) is an inherited disorder of unknown etiology, characterized by recurrent episodes of fever, peritonitis and/or pleuritis.~Fever is the cardinal manifestation of FMF and is present in most attacks accompanied by abdominal pain.~Another clinical manifestation in patients with FMF is exertional muscle pain, usually in the thigh, which appears even after minor exercise or physical activity in young patients with generally good health (other than FMF) and in good physical condition. Some patients also complain of ankle edema after relatively minor physical activity, which subsides after a night rest. Although these manifestations are quite common in FMF patients and form part of the minor criteria for the diagnosis, the etiopathogenesis has not been examined.~The purpose of the suggested study is to evaluate and characterize the anatomical and biochemical changes in the muscles of the thigh and in the ankle triggered by physical activity in FMF patients complaining of exertional lower leg myalgias and edema after minor physical exercise.", - "NCTID": "NCT00658060" - }, - { - "brief_title": "Chlorzoxazone in Hip and Knee Arthroplasty", - "phase": "Phase 4", - "drugs": "['chlorzoxazone', 'Placebo', 'THA', 'TKA']", - "drugs_list": [ - "chlorzoxazone", - "Placebo", - "THA", - "TKA" - ], - "diseases": "['Osteoarthritis of Hip', 'Osteoarthritis, Knee']", - "diseases_list": [ - "Osteoarthritis of Hip", - "Osteoarthritis", - "Knee" - ], - "enrollment": "400.0", - "inclusion_criteria": "inclusion criteria: \n\n Planned primary unilateral THA or TKA \n\n Patients (male/female) \u2265 18 \u00e5r \n\n Patients giving written informed consent and authority. \n\n Patients receiving spinal anaesthesia \n\n ", - "exclusion_criteria": ": \n\n Patients with intolerance to trial medications \n\n Rejection of or contraindicated spinal anaesthesia \n\n Patients with rheumatoid arthritis. \n\n Patients with Body Mass Index (BMI) \u2265 35 \n\n Patients that do not read or write Danish", - "brief_summary": "The purpose of this study is to elucidate whether patients operated with THA and TKA can benefit from treatment with chlorzoxazone.", - "NCTID": "NCT02405104" - }, - { - "brief_title": "Study of Resting and Exercising Body Functioning in Freeman-Sheldon Syndrome and Related Conditions", - "phase": "", - "drugs": "['Lactate, Glucose, and Adenosine Triphosphate Blood Levels', 'Physiological Stress Test', 'Functional Enquiry Form', 'Strength, Joint ROM, Girth and Length Measurements', 'Study Physical Examination', 'Observational Gait Analysis', 'Mental Health Interview']", - "drugs_list": [ - "Lactate", - "Glucose", - "and Adenosine Triphosphate Blood Levels", - "Physiological Stress Test", - "Functional Enquiry Form", - "Strength", - "Joint ROM", - "Girth and Length Measurements", - "Study Physical Examination", - "Observational Gait Analysis", - "Mental Health Interview" - ], - "diseases": "['Arthrogryposis', 'Craniofacial Abnormalities']", - "diseases_list": [ - "Arthrogryposis", - "Craniofacial Abnormalities" - ], - "enrollment": "0.0", - "inclusion_criteria": "Syndrome Group inclusion criteria: \n\n Freeman-Sheldon syndrome, \n\n Sheldon-Hall syndrome, \n\n Distal arthrogryposis type 1, or \n\n Distal arthrogryposis type 3 \n\n Deceased patients with enough clinical information available to satisfy study requirements \n\n Syndrome Group ", - "exclusion_criteria": ": \n\n Individuals not confirmed to have a condition under study \n\n Deceased patients without enough clinical information available to satisfy study requirements \n\n Patients with other anomalies, not having one of the above syndromes \n\n Patients or parents of minor children not willing to give consent \n\n Mature female patients who are pregnant or breast-feeding will be reassessed for consideration for enrolment. \n\n Mature female patients who are currently experiencing menses will be reassessed for consideration for enrolment. \n\n Patients with active, acute comorbid illness will be reassessed for consideration for enrolment. \n\n Control Group inclusion criteria: \n\n Subjects must be healthy and free of active disease. \n\n Subject or parent of minor child must be willing to give consent. \n\n Subjects must fall within the age-bracket to be matched with a Syndrome Group patient already screened and enroled in the study \n\n Subjects must be non-tobacco users and non-drinkers. \n\n Control Group ", - "brief_summary": "The hypotheses of the present study of Freeman-Sheldon syndrome (FSS) and related conditions are: (1) that exercise capacity is lower in FSS patients versus normal controls, and the lower exercise capacity is due to changes in the muscles' normal structure and an inability of sufficient quantity of the energy molecule to bind to muscle; (2) this muscle problem reduces amount of air that can get in the lung and amount of oxygen carried in the blood, which then has the effect of increasing heart and respiration rates, blood pressure, and deep body temperature, and produces muscle rigidity; (3) the events noted above, when they occur during cardiac stress testing, are related to a problem similar to malignant hyperthermia (MH) reported in some muscle disorders without use of drugs known to cause MH. MH (a life-threatening metabolic reaction that classically is triggered when susceptible persons receive certain drugs used in anaesthesia.", - "NCTID": "NCT01306994" - } - ], - "1": [ - { - "brief_title": "Surgical Lavage vs Serial Needle Aspiration for Infected Joints", - "phase": "Phase 3", - "drugs": "['Surgical Lavage (Arthrotomy)', 'Arthrocentesis (Serial needle aspiration)']", - "drugs_list": [ - "Surgical Lavage (Arthrotomy)", - "Arthrocentesis (Serial needle aspiration)" - ], - "diseases": "['Arthritis', 'Septic']", - "diseases_list": [ - "Arthritis", - "Septic" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with acute onset of symptoms of less than or equal to two weeks' duration. \n\n Patients with infection of only the following joints: ankle, knee, hip, wrist, elbow, or shoulder \n\n Patients with proven bacterial infection by positive gram stain or culture of synovial fluid and with white blood cell count in synovial flood consistent with infection (75,000 - 150,000 cells/mm3.) \n\n Cases with negative synovial fluid cultures if positive blood cultures are present and associated with typical inflammatory synovial fluid changes without other identifiable sources of infection and if antibiotic therapy had been initiated earlier to explain negative synovial fluid cultures. \n\n Monoarticular arthritis \n\n ", - "exclusion_criteria": ": \n\n Gonococcal infections \n\n Infected prosthetic joints \n\n Adjacent osteomyelitis preceding joint infection \n\n Septic arthritis occurring as an incidental event late in the course of otherwise fatal illness \n\n Patients that are 17 years old or less. \n\n Polyarticular arthritis.", - "brief_summary": "Joint spaces are aseptic areas, meaning that they do not contain microorganisms. Any injury to the joint space could cause the entry of microorganisms, with the potential to cause infection. Septic arthritis refers to the infection of a joint space with microorganisms, usually bacteria. This invasion initiates a process of inflammation and causes irreversible damage to a joint cavity. Patients typically present with pain, swelling, decreased motion, and inability to use the joint. When bacteria enter a joint space, the host immune system responds by concentrating inflammatory cells within the joint. While inflammatory cells serve to eliminate the bacteria, they also produce substances that not only attack bacteria but also could destroy the joint space. These substances are called enzymes, and they could damage the cartilage (translucent fairly elastic tissue around the joint) and adjacent bone in the process. Because cartilage has a poor ability to cure itself, this process may lead to irreversible damage and chronic joint dysfunction. Studies have found that signs of early joint damage can be found within hours following joint infection. This is true even if antibiotic therapy (medicine to fight the infection) is started within 24 hours of infection. Also, delay in treatment has been related to poor outcome. However, the best method of treating septic arthritis has yet to be determined. Currently, there are two accepted ways for treating septic arthritis: serial needle aspiration (introducing a needle in the joint to aspirate the inflammatory liquid), and surgical lavage (opening and cleaning the joint space in the OR under anesthesia). Antibiotics are also used with these two forms of treatment. Supporters of surgery believe that the most dependable method of eliminating bacteria from a joint space is through arthrotomy (opening the joint with a surgical incision) and lavage (irrigation of the joint with copious saline solution) .Promoters of serial needle aspiration support this method because it is quick, does not require opening the joint space, and can be performed without anesthesia.At present, there are no conclusive studies comparing the two techniques. Hopefully, this study will help delineate the best course of management.", - "NCTID": "NCT00313365" - }, - { - "brief_title": "Cancer Immune Therapy for the Treatment of Refractory Solid Tumours of Childhood", - "phase": "Phase 1", - "drugs": "['AV0113 DC-CIT', 'Data evaluation']", - "drugs_list": [ - "AV0113 DC-CIT", - "Data evaluation" - ], - "diseases": "['Childhood Solid Tumor']", - "diseases_list": [ - "Childhood Solid Tumor" - ], - "enrollment": "67.0", - "inclusion_criteria": "inclusion criteria: \n\n inclusion criteria for the safety and feasibility testing of AV0113 \n\n Male and female patients with a malignant neoplasia shall be eligible for this protocol provided they have no more conventional treatment options and have measurable disease. There is no age limit for participation in this study provided that the tumour is typical for the group of refractory solid neoplasias of childhood. \n\n Patients must not be HIV-positive. \n\n Patients must have primary tumour tissue or cells available at sufficient number to allow treatment according to the protocol. \n\n Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form. \n\n inclusion criteria for patients included in the long-term follow up and comparison with historic controls \n\n Patients suffering from bone or soft tissue sarcoma that received treatment with AV0113 or are documented in the database of the Medical University Vienna's Department of Orthopaedics. \n\n At least one disease recurrence after first CR or worse disease condition (e.g.: never reached CR). \n\n Diagnosis between 1992-2003 and/or inclusion time point during the years 2000-2004. \n\n Availability of date of death or of confirmation that patient is still alive (for the currentness of confirmation that patients are still alive only the time span from 1 April 2014 to 1 April 2015 is accepted). \n\n Patients not older than 27 years at their ITP. \n\n ", - "exclusion_criteria": ": \n\n ", - "brief_summary": "This is an un-blinded Phase 1 study in which 21 patients suffering from solid advanced paediatric malignancies (14 sarcoma and 7 non-sarcoma patients) are treated with AV0113, an anti-tumour immune therapy with autologous Dendritic Cells (DCs) loaded with tumour cell lysates, in order to investigate its safety and feasibility.~For obtaining a clearer picture of AV0113's utility in the treatment of bone and soft tissue sarcoma, a long-term (LT) follow-up investigation of the 14 sarcoma patients, which will be treated using the AV0113 Dendritic Cell Cancer Immune Therapy (DC-CIT) technology is planned, in order to gather first evidence for a potential LT effect of DC-CIT with AV0113.~Furthermore, a comparison of the 14 sarcoma patients treated with AV0113 DC-CIT with a cohort of matched historic control patients that were treated using standard of care will be conducted. It is planned to analyse 42 historic control sarcoma patients that will be matched for disease, recurrences, relapses etc.", - "NCTID": "NCT02533895" - }, - { - "brief_title": "A Study of Pre-Operative Treatment of Newly-Diagnosed, Surgically-Resectable Osteosarcoma With Doxorubicin, Ifosfamide, Etoposide, and Cisplatin With Early Metabolic Assessment of Response", - "phase": "Phase 1", - "drugs": "['Dexrazoxane', 'Doxorubicin', 'Cisplatin', 'G-CSF', 'PEG-filgrastim', 'Etoposide', 'Ifosfamide', 'Mesna', 'Leucovorin']", - "drugs_list": [ - "Dexrazoxane", - "Doxorubicin", - "Cisplatin", - "G-CSF", - "PEG-filgrastim", - "Etoposide", - "Ifosfamide", - "Mesna", - "Leucovorin" - ], - "diseases": "['Osteosarcoma', 'Lung Metastases']", - "diseases_list": [ - "Osteosarcoma", - "Lung Metastases" - ], - "enrollment": "2.0", - "inclusion_criteria": "inclusion criteria: \n\n Must be between 2 and 35 years of age at time of diagnosis \n\n Must have biopsy-proven, high-grade osteosarcoma. \n\n Patients with metastases are eligible as long as the lung is the only site of metastatic disease. \n\n The primary tumor and all pulmonary metastases must be deemed to be potentially resectable. There must be a commitment by the surgical team to resect the primary tumor at week 12, and pulmonary nodules at any point, unless the clinical situation indicates these interventions are not in the patient's best interest. \n\n Patients must have normal laboratory values and cardiac function as defined below: \n\n Creatinine clearance or radioisotope GFR of > or equal to 70ml/min/1.73 m2 OR \n\n A serum creatinine based on age/gender as follows: \n\n Age Maximum Serum Creatinine (mg/dL) Male Female \n\n 1 month to < 6 months 0.4 0.4 6 months to < 1 year 0.5 0.5 \n\n to < 2 years 0.6 0.6 \n\n to < 6 years 0.8 0.8 \n\n 6 to < 10 years 1 1 10 to < 13 years 1.2 1.2 13 to < 16 years 1.5 1.4 \n\n or equal to 16 years 1.7 1.4 \n\n Cardiac: Adequate cardiac function is defined as: \n\n Shortening fraction of > or equal to 28% by echocardiogram OR Ejection fraction of > or equal to 50% by radionuclide angiogram \n\n Hepatic: Adequate liver function is described as: \n\n Total bilirubin of < or equal to 1.5 x upper limit of normal (ULN) for age \n\n Hematologic function: adequate hematologic function is defined as: \n\n ANC > or equal to 1.5 x 10^9/L and platelet count > or equal to 100 x 10^9/L \n\n Female patients must have a negative pregnancy test \n\n Female patients who are lactating must agree to stop breast-feeding. \n\n Patients must not be known to be HIV positive. Testing for HIV is not mandatory. \n\n Sexually active patients of childbearing potential must agree to use effective contraception. \n\n Patients must be able to cooperate fully with all planned protocol therapy. \n\n Signed informed consent MUST be obtained from patient or parent/legal guardian prior to any study procedures and study entry. \n\n ", - "exclusion_criteria": ": \n\n Patients with any low-grade osteosarcoma, post-radiation osteosarcoma, and osteosarcoma associated with Paget's disease are not eligible. \n\n Patients with metastases other than lung metastases are not eligible. \n\n Patients may not have received prior chemotherapy.", - "brief_summary": "This is a pilot study that will allow investigators to collect data related to early and potentially more accurate response assessments using a chemotherapy protocol that eliminates methotrexate to maximize the dose intensity of doxorubicin. The pilot data will be used to seek funding to more fully address the hypotheses in a multi-institutional, Phase II or Phase III trial. The primary and secondary objectives are as follows:~Primary:~To evaluate the feasibility and potential usefulness of measuring early changes in tumor metabolic activity, assessed by Fludeoxyglucose-Positron Emission Tomography (FDG-PET) imaging and alkaline phosphatase activity, as early predictors of histological response rate at 12 weeks in osteosarcoma patients.~To explore whether histological response can be assessed by a computer algorithm using virtual microscopic images of pathology material, and whether quantifying necrosis in this way correlates with microscope slide-based review.~Secondary:~1. To gather pilot data on the histological response rate, 3-year event-free survival, and toxicity when children and young adults with resectable osteosarcoma are treated using a chemotherapy regimen of alternating courses of doxorubicin/cisplatin (DC) and doxorubicin/ifosfamide/etoposide (IDE).~All patients will receive 4 courses of preoperative chemotherapy courses. With the exception of high-dose methotrexate, which is given weekly, preoperative and postoperative chemotherapy courses are planned to begin every 21 days.~Patients with good histological response (those patients with > 90% tumor necrosis at time of definitive resection) will receive three postoperative chemotherapy courses. The 1st will consist of doxorubicin, dexrazoxane, cisplatin and Granulocyte-Colony Stimulating Factor (G-CSF)(or Polyethylene Glycol filgrastim). The 2nd course will consist of doxorubicin, dexrazoxane, ifosfamide, MESNA, etoposide, G-CSF (or PEG-filgrastim). The 3rd course will consist of ifosfamide, MESNA, etoposide, G-CSF (or PEG-filgrastrim). The total doxorubicin dose will be 450 mg/m2.~Patients with poor response (those patients with < 90% tumor necrosis found on pathology at time of definitive resection) will receive five postoperative chemotherapy courses. High Dose-Methotrexate will be administered during the 1st and 3rd postoperative chemotherapy courses as 4-weekly and 2-weekly doses, respectively. The 2nd course will consist of doxorubicin, dexrazoxane, cisplatin and G-CSF (or PEG-filgrastim). The 4th course will consist of doxorubicin, dexrazoxane, ifosfamide, Mesna, etoposide, G-CSF (or PEG-filgrastim). The 5th cycle will consist of ifosfamide, Mesna, etoposide, G-CSF (or PEG-filgrastrim). The total doxorubicin dose will be 450 mg/m2.", - "NCTID": "NCT01258634" - }, - { - "brief_title": "Ixabepilone in Treating Young Patients With Solid Tumors or Leukemia That Haven't Responded to Therapy", - "phase": "Phase 1", - "drugs": "['ixabepilone']", - "drugs_list": [ - "ixabepilone" - ], - "diseases": "['Brain and Central Nervous System Tumors', 'Childhood Germ Cell Tumor', 'Extragonadal Germ Cell Tumor', 'Kidney Cancer', 'Leukemia', 'Liver Cancer', 'Neuroblastoma', 'Ovarian Cancer', 'Sarcoma', 'Unspecified Childhood Solid Tumor, Protocol Specific']", - "diseases_list": [ - "Brain and Central Nervous System Tumors", - "Childhood Germ Cell Tumor", - "Extragonadal Germ Cell Tumor", - "Kidney Cancer", - "Leukemia", - "Liver Cancer", - "Neuroblastoma", - "Ovarian Cancer", - "Sarcoma", - "Unspecified Childhood Solid Tumor", - "Protocol Specific" - ], - "enrollment": "30.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Meets 1 of the following criteria: \n\n Histologically confirmed solid tumor (closed to accrual as of 10/4/2007) that relapsed after or failed to respond to front-line curative therapy and for which no other potentially curative treatment options exist \n\n Curative therapy may include surgery, radiotherapy, chemotherapy, or any combination of these modalities \n\n Eligible tumor types include, but are not limited to, the following: \n\n Rhabdomyosarcoma \n\n Other soft tissue sarcomas \n\n Ewing's sarcoma family of tumors \n\n Osteosarcoma \n\n Neuroblastoma \n\n Wilms' tumor \n\n Hepatic tumors \n\n Germ cell tumors \n\n Primary brain tumors \n\n Histologic confirmation may be waived for brain stem or optic glioma \n\n Diagnosis of relapsed or refractory leukemia \n\n Patients with refractory or second or greater relapsed leukemia must have > 25% blasts in the bone marrow (M3 bone marrow) with or without active extramedullary disease (except for leptomeningeal disease) \n\n Relapsed after or failed to respond to frontline curative therapy and no other potentially curative therapy (e.g., radiotherapy, chemotherapy, or any combination of these modalities) exists \n\n Patients with acute promyelocytic leukemia must be refractory to treatment with retinoic acid and arsenic trioxide \n\n Patients with Philadelphia chromosome positive chronic myelogenous leukemia must be refractory to imatinib \n\n No active CNS leukemia (CNS3) \n\n PATIENT CHARACTERISTICS: \n\n Age: \n\n 2 to 18 (solid tumor patients [closed to accrual as of 10/4/2007]) \n\n 1 to 21 (leukemia patients) \n\n Performance status: \n\n For patients age 11 to 21: \n\n Karnofsky 50-100% \n\n For patients age 1 to 10: \n\n Lansky 50-100% \n\n Life expectancy: \n\n Not specified \n\n Hematopoietic: \n\n Platelet count at least 100,000/mm^3 (20,000/mm^3 for leukemia patients) \n\n Hemoglobin \u2265 8.0 g/dL \n\n Hepatic: \n\n Bilirubin less than 1.5 times upper limit of normal (ULN) \n\n SGOT and SGPT less than 2.5 times ULN \n\n No hepatic dysfunction that would preclude study \n\n Renal: \n\n Creatinine normal for age OR \n\n Creatinine clearance at least 60 mL/min \n\n No renal dysfunction that would preclude study \n\n Other: \n\n No known severe prior hypersensitivity reaction to agents containing Cremophor EL \n\n No clinically significant unrelated systemic illness (e.g., serious infections or other organ dysfunction) that would preclude study \n\n No grade 2 or greater preexisting sensory neuropathy \n\n More than 2 month since prior and no concurrent evidence of graft vs host disease \n\n Not pregnant or nursing \n\n Negative pregnancy test \n\n Fertile patients must use effective contraception \n\n PRIOR CONCURRENT THERAPY: \n\n Biologic therapy: \n\n Recovered from all therapy-related acute toxic effects (leukemia patients only) \n\n Prior epoetin alfa allowed \n\n At least 3 days since other prior colony-stimulating factors (e.g., filgrastim (G-CSF), sargramostim (GM-CSF), or interleukin-11 (IL-11)) \n\n At least 6 months since prior bone marrow transplantation \n\n At least 2 months since prior stem cell transplantation or rescue (leukemia patients) \n\n At least 7 days since prior therapy with a biological agent and hematopoietic growth factor with the exception of erythropoietin \n\n More than 3 weeks since prior monoclonal antibody therapy (leukemia patients only) \n\n No concurrent GM-CSF or IL-11 \n\n No concurrent immunotherapy \n\n Chemotherapy: \n\n See Disease Characteristics \n\n Recovered from all therapy-related acute toxic effects (leukemia patients only) \n\n At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) \n\n No other concurrent anticancer chemotherapy \n\n Endocrine therapy: \n\n Concurrent corticosteroids allowed for the control of symptoms related to tumor-associated edema in patients with brain tumors \n\n Patients with brain tumors must be on a stable or tapering dose of corticosteroids for 7 days before baseline scan is performed for the purpose of assessing response to study therapy \n\n Must be on a stable or tapering dose of corticosteroids for 7 days prior to study entry (leukemia patients only) \n\n Radiotherapy: \n\n See Disease Characteristics \n\n Recovered from all therapy-related acute toxic effects (leukemia patients only) \n\n At least 4 weeks since prior radiotherapy \n\n More than 2 weeks since prior local palliative radiotherapy (leukemia patients only) \n\n More than 3 months since prior total-body irradiation, craniospinal radiotherapy, or radiotherapy to \u226550% of the pelvis (leukemia patients only) \n\n More than 6 weeks since prior other substantial bone marrow radiotherapy (leukemia patients only) \n\n No prior extensive radiotherapy (e.g., craniospinal irradiation, total body irradiation, or radiotherapy to more than half of the pelvis) \n\n No concurrent anticancer radiotherapy \n\n Surgery: \n\n See Disease Characteristics \n\n Other: \n\n Recovered from prior therapy \n\n At least 30 days since any prior investigational anticancer therapy \n\n At least 1 week since prior known inhibitors of CYP3A4, including any of the following: \n\n Antibiotics (i.e., clarithromycin, erythromycin, or troleandomycin) \n\n Anti-HIV agents (i.e, delaviridine, nelfinavir, amprenavir, ritonavir, idinavir, saquinavir, or lopinavir) \n\n Anti-fungals (i.e., itraconazole, ketoconazole, fluconazole [doses > 3mg/kg/day], or voriconazole) \n\n Anti-depressants (i.e., nefaxodone or fluovoxamine) \n\n Calcium channel blockers (i.e., verapamil or diltiazem) \n\n Anti-emetics (i.e., aprepitant [Emend\u00ae]) \n\n Miscellaneous agents (i.e., amiodarone) \n\n Grapefruit juice \n\n No other concurrent investigational agents \n\n No concurrent St. John's Wort \n\n No concurrent known inhibitors of CYP3A4, including grapefruit juice \n\n Concurrent other agents inducing CYP3A4 allowed", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone in treating young patients with relapsed or refractory solid tumors or leukemia.", - "NCTID": "NCT00030108" - }, - { - "brief_title": "A Phase I Trial of T Cells Expressing an Anti-GD2 Chimeric Antigen Receptor in Children and Young Adults With GD2+ Solid Tumors", - "phase": "Phase 1", - "drugs": "['Anti-GD2-CAR engineered T cells', 'AP1903', 'Cyclophosphamide']", - "drugs_list": [ - "Anti-GD2-CAR engineered T cells", - "AP1903", - "Cyclophosphamide" - ], - "diseases": "['Sarcoma', 'Osteosarcoma', 'Neuroblastoma', 'Melanoma']", - "diseases_list": [ - "Sarcoma", - "Osteosarcoma", - "Neuroblastoma", - "Melanoma" - ], - "enrollment": "15.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis \n\n (a) Osteosarcoma, neuroblastoma and melanoma that have been treated with standard frontline therapy and are judged to be incurable with standard therapy, based upon the fact that they are unresectable, metastatic, progressive/persistent or recurrent. \n\n Evaluable disease must be present. \n\n i) For all histologies except osteosarcoma and neuroblastoma, pathologic review of frozen tissue must document GD2+ expression. Positive expression is defined as at least 2+ expression (0-4+ scale) in >50 percent of the tumor cells using anti-GD2 mAb 14G2a. If adequate archived frozen tissue is available, this may be utilized, or if not, patients may undergo biopsy following enrollment to obtain tissue to assess GD2 expression, with the following restrictions. \n\n ii) Patients with histologies other than osteosarcoma or neuroblastoma must have adequate accessible tumor for biopsy (at least 1 cm diameter). \n\n iii) Procedures employed to acquire biopsies for tumor lysates will be limited to percutaneous needle or core biopsies, thoracoscopic excision or open biopsies of readily accessible lesions. Pulmonary lesions may be biopsied but extensive surgery such as thoracotomy or laparotomy should not be employed. \n\n iv) Patients who will require biopsy should not be enrolled if in the opinion of the principal investigator, the tumor site places the patient at substantial risk from the biopsy procedure. \n\n Weight greater than or equal to 15 kg \n\n Age less than or equal to 35 years old at the time of enrollment. \n\n Prior Therapy: \n\n The patient s malignancy must have relapsed after or failed to respond to frontline curative therapy and/or there must not be any curative treatment options available at the time of study entry. \n\n There is no limit to the number of prior treatment regimens. However, patients must have fully recovered from the acute toxic effects of prior chemotherapy, immunotherapy, or radiotherapy prior to study enrollment. Any grade 3 or 4 non-hematologic toxicity of any previous therapy must have resolved to grade 2 or less. \n\n Myelosuppressive chemotherapy: Patients must not have received myelosuppressive chemotherapy within 3 weeks of enrollment (6 weeks if prior nitrosourea). \n\n Hematopoietic growth factors: At least 7 days must have elapsed since the completion of therapy with a growth factor. At least 14 days must have elapsed after receiving pegfilgrastim. \n\n At least 7 days must have elapsed since the completion of therapy with a biologic agent, targeted agent, tyrosine kinease inhibitor or a metronomic nonmyelosuppressive regimen. \n\n Monoclonal antibodies: At least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody. \n\n Radiotherapy: 3 weeks must have elapsed since XRT \n\n Performance status: \n\n ECOG 0, 1 or 2, or for children less than or equal to 10 years of age, Lansky greater than or equal to 60. \n\n Cardiac function: \n\n Left ventricular ejection fraction greater than or equal to 40 percent or fractional shortening greater than or equal to 28 percent. \n\n Liver function: \n\n Serum total bilirubin < 2 mg/dl, serum AST and ALT less than or equal to 3 x upper limit of normal. Patients with Gilbert s syndrome are excluded from the requirement of a normal bilirubin and patients will not be excluded if liver enzyme elevation is due to tumor involvement. (Gilbert s syndrome is found in 3-10% of the general population, and is characterized by mild, chronic unconjugated hyperbilirubinemia in the absence of liver disease or overt hemolysis). NOTE: Adult values will be used for calculating hepatic toxicity and determining eligibility, as is standard on POB phase I trials. \n\n Renal function: \n\n Age-adjusted normal serum creatinine according to the following table or a creatinine clearance greater than or equal to 60 ml/min/1.73 m(2). \n\n Age less than or equal to 5 Maximum serum creatinine (mg/dl) 0.8 \n\n Age greater than 5 and less than or equal to 10 Maximum serum creatinine (mg/dl) 1.0 \n\n Age greater than 10 and less than or equal to 15 Maximum serum creatinine (mg/dl) 1.2 \n\n Age greater than 15 Maximum serum creatinine (mg/dl) 1.5 \n\n Marrow function: \n\n ANC must be > 750/mm(3), platelet count must be greater than or equal to 75,000/mm(3) (not achieved by transfusion). \n\n Ability to give informed consent. \n\n For patients <18 years of age, their legal guardian must give informed consent. Pediatric patients will be included in age-appropriate discussion in order to obtain verbal assent. \n\n Durable power of attorney form offered (patients (Bullet)18 years of age only). \n\n Birth Control \n\n Female and male patients (and when relevant their partners) must be willing to practice birth control (including abstinence) during and for two months after treatment, if of childbearing potential. \n\n ", - "exclusion_criteria": ": \n\n Concurrent Illnesses \n\n Clinically significant systemic illness (e.g. serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the judgment of the PI would compromise the patient s ability to tolerate protocol therapy or significantly increase the risk of complications. \n\n Peripheral nerve symptoms from prior therapies or from tumor compression > grade 1. \n\n Untreated CNS metastasis \n\n Extradural masses that have not invaded the brain parenchyma or parameningeal tumors without evidence for leptomeningeal spread will not render the patient ineligible. Patients with previous CNS tumor involvement that has been treated and is stable for at least 6 weeks following completion of therapy are eligible. \n\n Prior Therapy \n\n Previous treatment with genetically engineered GD2-CAR T cells. Previous vaccine therapy, anti-GD2 mAb therapy or therapy with other genetically engineered T cells is not an ", - "brief_summary": "Background~GD2 is a well-characterized tumor antigen in neuroblastoma, which is also expressed on osteosarcomas and some other sarcomas. T cells expressing 1st generation anti-GD2 chimeric antigen receptors (CARs) were safe and mediated modest antitumor activity in some patients with refractory neuroblastoma.~A 3rd generation anti-GD2-CAR (GD2-CAR.OX40.28.z.ICD9) has been produced and holds promise for increased activity compared to the 1st generation GD2-CAR already studied in clinical trials. As an added safety measure, the vector includes a suicide switch comprising a caspase dimerization domain (ICD9) that can be activated by a small molecule to induce death of the genetically engineered cells if they were induce untoward toxicity.~Objectives~Primary:Determine the feasibility of producing anti GD2-CAR cells meeting the established release criteria and to assess the safety of administering escalating doses of anti-GD2-CAR engineered T cells in children and young adults with GD2+ solid tumors, including neuroblastoma, following cyclophosphamide-based lymphodepletion.~Secondary:~Determine if administration anti-GD2-CAR engineered T cells mediate antitumor effects in children and young adults with GD2+ solid tumors;~Measure persistence of adoptively transferred anti-GD2-CAR T cells and correlate this with antitumor effects;~Extend information regarding the prevalence and intensity of GD2 expression in non-neuroblastoma, non-osteosarcoma solid tumors in children and young adults;~If unacceptable toxicity occurs that is possibly, probably or likely related to anti-GD2-CAR T cells, assess the capacity for AP1903, a dimerizing agent, to mediate clearance of the genetically engineered cells and resolve toxicity; and~Assess toxicity of AP1903 if administered to mediate clearance of anti-GD2-CAR T cells.~Eligibility~Patients 1-35 years of age, at least 15 kg, with osteosarcoma or a GD2+ solid tumor (including neuroblastoma) that has recurred after or not responded to standard therapy and is deemed incurable by standard therapy.~Design~After apheresis to collect T cells for transduction, patients receive cyclophosphamide 1800mg/m(2)/d as a lymphodepleting regimen. A phase I cell dose escalation scheme will used at 4 dose levels (1 x 10(5) transduced T cells/kg; 1 x 10(6) transduced T cells/kg; 3 x 10(6) transduced T cells/kg; and 1 x 10(7) transduced T cells/kg), using a standard 3 plus 3 dose escalation design. An expanded group of a total of 12 patients will be treated at the highest dose, comprising at least 6 osteosarcoma patients.~Patients will be monitored for toxicity, antitumor effects and persistence of anti-GD2-CAR T cells.~Patients with a PR, SD may receive a 2nd cycle at the next higher dose level a minimum of 60 days following completion of the first cycle if eligibility criteria are met.~A maximum of 36 patients may be treated on this study. Given that there is likelihood that some patients with non-osteosarcoma will not meet the criteria for GD2 expression to be eligible for enrollment, up to 72 subjects will be screened to enroll a maximum of 36 patients for treatment. Up to 2-3 patients will be accrued per month, and therefore this study may require up to 2-3 years to complete enrollment and treatment.~...", - "NCTID": "NCT02107963" - }, - { - "brief_title": "Glembatumumab Vedotin in Treating Patients With Recurrent or Refractory Osteosarcoma", - "phase": "Phase 2", - "drugs": "['Glembatumumab Vedotin', 'Laboratory Biomarker Analysis', 'Pharmacological Study']", - "drugs_list": [ - "Glembatumumab Vedotin", - "Laboratory Biomarker Analysis", - "Pharmacological Study" - ], - "diseases": "['Recurrent Osteosarcoma']", - "diseases_list": [ - "Recurrent Osteosarcoma" - ], - "enrollment": "22.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients must have had histologic verification of osteosarcoma at original diagnosis or relapse \n\n Patients must have measurable disease according to RECIST 1.1, and have relapsed or become refractory to conventional therapy \n\n Patient must have archival tumor specimen available for submission \n\n Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age \n\n Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study \n\n Myelosuppressive chemotherapy: must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea) \n\n Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent \n\n Radiation therapy (RT): >= 2 weeks for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation \n\n Monoclonal antibodies: must not have received any monoclonal based therapies within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) within 2 weeks, prior to study enrollment \n\n Peripheral absolute neutrophil count (ANC) >= 1000/uL \n\n Platelet count >= 75,000/uL (transfusion independent) \n\n Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) \n\n Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows: \n\n Age 1 to < 2 years (male and female: 0.6 mg/dL) \n\n Age 2 to < 6 years (male and female: 0.8 mg/dL) \n\n Age 6 to < 10 years (male and female: 1 mg/dL) \n\n Age 10 to < 13 years (male and female: 1.2 mg/dL) \n\n Age 13 to < 16 years (male: 1.5 mg/dL and female: 1.4 mg/dL) \n\n Age >= 16 (male: 1.7 mg/dL and female: 1.4 mg/dL) \n\n Total bilirubin =< 1.5 x upper limit of normal (ULN) for age \n\n Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 110 U/L; for the purposes of this study the ULN for SGPT is defined as 45 U/L \n\n Serum albumin > 2 g/dL \n\n Shortening fraction of >= 27% by echocardiogram, or \n\n Ejection fraction of >= 50% by radionuclide angiogram \n\n All patients and/or their parents or legal guardians must sign a written informed consent \n\n All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met \n\n ", - "exclusion_criteria": ": \n\n Patients with > grade 2 neuropathy according to the Modified (Balis) Pediatric Scale of Peripheral Neuropathies will be excluded except in cases in which neuropathy is secondary to prior surgery \n\n Patients who have previously received CDX-011 (CR011-vc monomethyl auristatin E [MMAE]; CDX-011) or other MMAE-containing agents \n\n Patients who have received other investigational drugs within 2 weeks or 5 half-lives (whichever is longer) prior to study enrollment \n\n Patients with a history of allergic reactions attributed to compounds of similar composition to dolastatin or auristatin; compounds of similar composition include auristatin PHE as an anti-fungal agent, auristatin PE (TZT-1027, Soblidotin, NSC-654663) as an anti-tumor agent and symplostatin 1 as an anti-tumor agent \n\n Patients with known central nervous system metastasis are not eligible \n\n Patients who have had major surgery within 2 weeks prior to enrollment are not eligible; procedures such as placement of a central vascular catheter, or limited tumor biopsy, are not considered major surgery \n\n Female patients who are pregnant are ineligible \n\n Lactating females are not eligible unless they have agreed not to breastfeed their infants \n\n Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained \n\n Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation and for 2 months after the end of study treatment", - "brief_summary": "This phase II trial studies how well glembatumumab vedotin works in treating patients with osteosarcoma that has come back (recurrent) or does not respond to treatment (refractory). Monoclonal antibodies, such as glembatumumab vedotin, may find tumor cells and help kill them.", - "NCTID": "NCT02487979" - }, - { - "brief_title": "Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer", - "phase": "Phase 2", - "drugs": "['cyclophosphamide', 'doxorubicin hydrochloride', 'etoposide', 'ifosfamide', 'vincristine sulfate', 'conventional surgery', 'radiation therapy']", - "drugs_list": [ - "cyclophosphamide", - "doxorubicin hydrochloride", - "etoposide", - "ifosfamide", - "vincristine sulfate", - "conventional surgery", - "radiation therapy" - ], - "diseases": "['Kidney Cancer', 'Sarcoma']", - "diseases_list": [ - "Kidney Cancer", - "Sarcoma" - ], - "enrollment": "", - "inclusion_criteria": "DISEASE CHARACTERISTICS: Diagnosis of peripheral primitive neuroectodermal tumor, including peripheral neuroepithelioma or Askin tumor OR Diagnosis of localized or metastatic Ewing's sarcoma, including the following: Unresectable or metastatic small cell osteosarcoma Unresectable or metastatic other nonrhabdomyosarcomatous soft-tissue sarcomas Unresectable or metastatic other non-osteosarcomatous bone sarcomas Desmoplastic small round-cell tumor Metastatic or non-metastatic Wilms' tumor Immunocytochemistry, electron microscopy, and/or chromosomal analysis may be required to rule out other small round cell neoplasms \n\n PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified \n\n PRIOR CONCURRENT THERAPY: Not specified", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells.~PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients with peripheral neuroectodermal tumors, Ewing's sarcoma, Wilms' tumor, or bone cancer.", - "NCTID": "NCT00002466" - }, - { - "brief_title": "Monoclonal Antibody A1G4 Plus BCG in Treating Patients With Cancer", - "phase": "Phase 1", - "drugs": "['BCG vaccine', 'monoclonal antibody A1G4 anti-idiotype vaccine']", - "drugs_list": [ - "BCG vaccine", - "monoclonal antibody A1G4 anti-idiotype vaccine" - ], - "diseases": "['Neuroblastoma', 'Sarcoma']", - "diseases_list": [ - "Neuroblastoma", - "Sarcoma" - ], - "enrollment": "24.0", - "inclusion_criteria": "DISEASE CHARACTERISTICS: \n\n Histologically confirmed GD2 positive tumors which include: \n\n High risk neuroblastoma (stage IV, or N-myc amplified, or localized neuroblastoma multiply recurrent) \n\n Recurrent or metastatic osteosarcoma \n\n Recurrent or metastatic GD2 positive sarcomas \n\n If free of disease, patient must be fully recovered from toxic effects or complications of prior treatments (chemotherapy or surgery) \n\n No greater than 6 months since last chemotherapy or surgery before first injection of A1G4 \n\n PATIENT CHARACTERISTICS: \n\n Age: \n\n Any age \n\n Performance status: \n\n Not specified \n\n Life expectancy: \n\n At least 6 months \n\n Hematopoietic: \n\n Absolute neutrophil count greater than 500/mm^3 \n\n Absolute leukocyte count greater than 500/mm^3 \n\n Peripheral T-cell phytohemagglutinin activation (PHA) at least 50% of normal \n\n Hepatic: \n\n Not specified \n\n Renal: \n\n Not specified \n\n Cardiovascular: \n\n No significant heart disease (NYHA class III or IV) \n\n Other: \n\n No other serious intercurrent illnesses \n\n No active infections requiring antibiotics \n\n No active bleeding \n\n No primary immunodeficiency \n\n Not pregnant or nursing \n\n Adequate contraception required of all fertile patients \n\n PRIOR CONCURRENT THERAPY: \n\n Biologic therapy: \n\n No concurrent antibiotics \n\n No prior mouse antibodies and detectable human antimouse antibody (HAMA) titer \n\n Chemotherapy: \n\n See Disease Characteristics \n\n At least 6 weeks since nitrosoureas \n\n At least 4 weeks since other systemic chemotherapy \n\n Endocrine therapy: \n\n No concurrent nonsteroidal anti-inflammatory agents \n\n No concurrent corticosteroid \n\n Radiotherapy: \n\n At least 4 weeks since radiotherapy \n\n No prior radiation therapy to the spleen \n\n Surgery: \n\n See Disease Characteristics \n\n No splenectomy", - "exclusion_criteria": "", - "brief_summary": "RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody A1G4 with BCG may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody A1G4 plus BCG in treating patients with cancer.", - "NCTID": "NCT00003023" - } - ], - "2": [] - }, - { - "patient_id": "sigir-201526", - "patient": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", - "0": [ - { - "brief_title": "Conventional Infertility Treatment vs. Fast Track to IVF", - "phase": "", - "drugs": "['intrauterine insemination', 'infertility']", - "drugs_list": [ - "intrauterine insemination", - "infertility" - ], - "diseases": "['Infertility']", - "diseases_list": [ - "Infertility" - ], - "enrollment": "503.0", - "inclusion_criteria": "inclusion criteria: \n\n Female partner age 21 up to 40th birthday, at the time of recruitment. Infertility is defined as failure to conceive a recognized pregnancy after one year (or 12 menstrual cycles) of unprotected intercourse. \n\n Male partner has a normal semen analysis with a sperm concentration of >15 million total motile sperm, >1% normal forms by strict criteria, or >5 million total motile sperm on IUI prep. \n\n Female patient has at least one ovary and at least one ipsilateral patent fallopian tube confirmed by HSG or laparoscopy; pelvic pathology amenable to operative laparoscopy (pelvis restored to functional). The open tube cannot have had a previous ectopic (tubal) pregnancy and the closed tube cannot be a hydrosalpinx (a tube that is blocked at the end and filled with fluid), unless a tubal ligation has been performed at the junction of the uterus and fallopian tube. \n\n Patients with surgically corrected stages I and II endometriosis will be included. \n\n Normal uterine cavity demonstrated by HSG, Sonohysterogram (SHG), or hysteroscopy; pathologies of uterine cavity amenable to operative hysteroscopy (cavity restored to normal and demonstrated by post operative study). \n\n Anovulatory patients who did not conceive after a minimum of three ovulatory cycles with any medications, not including gonadotropin therapy. Anovulatory patients unable to achieve ovulation at dosages up to 150 mg of clomiphene or standard dosages of other ovulation inducing medications (i.e. bromocriptine). Hypoestrogenic hypothalamic amenorrhea patients will qualify immediately for inclusion, prior to any gonadotropin therapy. \n\n Normal ovarian reserve demonstrated in all patients i.e., cycle day 3 FSH/E2 values of <15 mIU/mL and <100 pg/mL, respectively. Normal TSH and prolactin. \n\n Female body mass index \u2264 38. \n\n ", - "exclusion_criteria": ": \n\n Previous tubal reconstructive surgery in which the pelvis was not restored to functional. \n\n Unilateral or bilateral hydrosalpinx (a tube that is blocked at the end and filled with fluid) that has not had a tubal ligation performed at the junction of the uterus and fallopian tubes. \n\n A laparoscopy that demonstrated pelvic adhesions or endometriosis for which the pelvis could not be restored to normal by surgery or endometriosis was not ablated or excised. All patients with stages III and IV endometriosis. \n\n One or more prior ectopic pregnancies in which one or both tubes were rendered nonfunctional; two or more ectopic pregnancies, even if tubes are patent. \n\n Severe male factor (i.e.; semen analysis with a sperm concentration of <15 million total motile sperm, <1% normal forms by strict criteria, or <5 million total motile sperm on IUI prep). Couples using donor semen will be excluded. \n\n Previous treatment with IUI or IVF. Previous treatment of normal ovulation patients with gonadotropins. \n\n Inadequate ovarian reserve demonstrating FSH >15 mIU/mL or estradiol > 100 pg/mL. \n\n Patients requiring gamete intrafallopian tube transfer (GIFT), zygote intrafallopian tube transfer (ZIFT), or tubal embryo transfer (TET). \n\n Female body mass index > 38.", - "brief_summary": "The purpose of this randomized prospective clinical trial is to determine whether an infertility treatment that moves quickly to In Vitro Fertilization (IVF) is more cost effective than the usual treatment strategy which includes various combinations of infertility drugs and intrauterine insemination (IUI) prior to utilizing In Vitro Fertilization.", - "NCTID": "NCT00260091" - }, - { - "brief_title": "Randomized Population-Based Study on Chlamydia Trachomatis Screening", - "phase": "", - "drugs": "['Screening for urogenital Chlamydia trachomatis']", - "drugs_list": [ - "Screening for urogenital Chlamydia trachomatis" - ], - "diseases": "['Chlamydia Trachomatis', 'Infertility', 'Ectopic Pregnancy']", - "diseases_list": [ - "Chlamydia Trachomatis", - "Infertility", - "Ectopic Pregnancy" - ], - "enrollment": "30000.0", - "inclusion_criteria": "inclusion criteria: \n\n born in 1974, 1974 or 1976 AND living in Aarhus County October 1007 \n\n ", - "exclusion_criteria": ": \n\n -", - "brief_summary": "30,000 individuals living in Aarhus County, Denmark by Oct 1997 were randomized into two groups. The intervention group received an invitation to be tested for urogenital Chlamydia trachomatis by use of home-obtained and mailed sample (9,000 individuals). The control group received no intervention (21,000 individuals). Outcome measures: Number of tested individuals, number of detected infections, number of women developing PID, ectopic pregnancy or infertility, number of women giving birth to a child, number of women receiving IVF treatment and number of men developing epididymitis.~The hypothesis was that more individuals would be tested and treated for infections and that number of long term fertility complications would decline in the intervention group compared to control group.", - "NCTID": "NCT00827970" - }, - { - "brief_title": "Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery", - "phase": "Phase 3", - "drugs": "['ADHEXIL']", - "drugs_list": [ - "ADHEXIL" - ], - "diseases": "['Ovarian Cysts', 'Endometriosis', 'Adhesions']", - "diseases_list": [ - "Ovarian Cysts", - "Endometriosis", - "Adhesions" - ], - "enrollment": "80.0", - "inclusion_criteria": "inclusion criteria: \n\n Female patients aged 18-45 years at screening. \n\n Patients undergoing elective laparoscopic surgery involving at least one adnexa. \n\n ", - "exclusion_criteria": ": \n\n Pregnant (including ectopic pregnancy) or breastfeeding patient. \n\n Patients with a documented diagnosis of cancer. \n\n Patients with a lymphatic, hematologic or coagulation disorder. \n\n Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil\u2122. \n\n Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants. \n\n Patients who have participated in another clinical study within 30 days of enrolment. \n\n Investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study.", - "brief_summary": "The objective of this study is to evaluate the safety and efficacy of ADHEXIL\u2122 in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.", - "NCTID": "NCT00865488" - }, - { - "brief_title": "Sonographic Assessment and Visualization of Ectopics in Emergency Medicine", - "phase": "", - "drugs": "['Pelvic Ultrasound']", - "drugs_list": [ - "Pelvic Ultrasound" - ], - "diseases": "['Ectopic Pregnancy']", - "diseases_list": [ - "Ectopic Pregnancy" - ], - "enrollment": "600.0", - "inclusion_criteria": "inclusion criteria: \n\n pregnant females in 1st trimester \n\n present to emergency department \n\n complaint of abdominal/pelvic pain or vaginal bleeding \n\n ", - "exclusion_criteria": ": \n\n previous ultrasound diagnostic of location of pregnancy", - "brief_summary": "Observational study of the use of ultrasound by emergency physicians in the evaluation of patients at risk of ectopic pregnancy.", - "NCTID": "NCT01322958" - }, - { - "brief_title": "Immunopathogenesis of Chlamydia", - "phase": "", - "drugs": "['No intervention, only observational']", - "drugs_list": [ - "No intervention", - "only observational" - ], - "diseases": "['CHLAMYDIA INFECTIONS']", - "diseases_list": [ - "CHLAMYDIA INFECTIONS" - ], - "enrollment": "29.0", - "inclusion_criteria": "inclusion criteria: \n\n Female \n\n 11 to 21 years of age at the time of enrollment \n\n Positive for Chlamydia infections by urine or cervical PCR \n\n 5th Chlamydia-negative subject who fits all other inclusion criteria \n\n Negative pregnancy test \n\n Written informed consent provided \n\n Signed a HIPAA authorization form \n\n Willingness to comply with all the requirements of the protocol \n\n ", - "exclusion_criteria": ": \n\n Positive pregnancy test \n\n Negative for Chlamydia, unless 5th negative subject to be in the control group \n\n Any condition that in the opinion of the investigator would interfere with the ability of the potential subject to complete the study or would result in significant risk to the subject", - "brief_summary": "Sexually transmitted Chlamydia trachomatis infections are a widespread public health concern due to their prevalence and potentially devastating reproductive consequences, including pelvic inflammatory disease, infertility, and ectopic pregnancy. The goal of this study is to evaluate the risk factors for adverse outcomes following genital tract infection with Chlamydia trachomatis and to evaluate whether or not the presence of C. trachomatis in the rectum act as a reservoir for infection.", - "NCTID": "NCT00607659" - }, - { - "brief_title": "Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil", - "phase": "Phase 1; Phase 2", - "drugs": "['Anti adhesion agent']", - "drugs_list": [ - "Anti adhesion agent" - ], - "diseases": "['Bilateral Ovarian Disease']", - "diseases_list": [ - "Bilateral Ovarian Disease" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n Female patients aged 18-45 years at screening \n\n Patients undergoing elective laparoscopic surgery due to known or suspected bilateral ovarian disease \n\n ", - "exclusion_criteria": ": \n\n Pregnant (including ectopic pregnancy) or breastfeeding patient \n\n Patients with a documented diagnosis of cancer \n\n Patients with a lymphatic, hematologic or coagulation disorder \n\n Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil\u2122 \n\n Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants. \n\n Patients who have participated in another clinical study within 30 days of enrolment. \n\n Investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study.", - "brief_summary": "The objective is to evaluate the safety and initial efficacy of the Omrix Anti-Adhesion (AA) kit, Adhexil\u2122 in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.", - "NCTID": "NCT00544310" - }, - { - "brief_title": "The Prognosis of Early Pregnancy With Post Coital Bleeding", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Vaginal Bleeding During Pregnancy', 'Postcoital Bleeding']", - "diseases_list": [ - "Vaginal Bleeding During Pregnancy", - "Postcoital Bleeding" - ], - "enrollment": "120.0", - "inclusion_criteria": "inclusion criteria: \n\n women (age 18-40) with early pregnancy (4-23 weeks) with singleton or twins pregnancy that address to the Women E.R. due to vaginal bleeding. \n\n ", - "exclusion_criteria": ": \n\n age >40 or <18 \n\n women with history of more then 3 abortions. \n\n women with history of more then 2 pre term labor \n\n ectopic pregnancy \n\n placental previa \n\n women who takes anticoagulation therapy \n\n women with known pathology at cervix. \n\n women with known uterus defect. pregnancies with chromosomal defects or birth defects that was discovered at the screening tests.", - "brief_summary": "This is a prospective study, where the investigators will monitor pregnant women at 4-23 weeks of pregnancy coming to the Women- E.R. at Meir Hospital due to spontaneous -or after intercourse- bleeding or bleeding secretions. The women will fill out questionnaires regarding past illness, vaginal bleeding, and gynecologic history. Then they will undergo full examination including ultrasound. After discharge, the investigators will recommend to all the women who came due to bleeding or bleeding secretions to avoid intercourse for two weeks after the bleeding stops. Afterwards they will be monitored until their delivery date (filling questionnaires a month after coming to the E.R. and at the end of the pregnancy). After they give birth the investigators will assess the rate of pregnancy, obstetric and embryonic complications in each of the study groups.", - "NCTID": "NCT02363569" - }, - { - "brief_title": "Postpartum Intrauterine Device Study", - "phase": "", - "drugs": "['Copper T380A Intrauterine Device']", - "drugs_list": [ - "Copper T380A Intrauterine Device" - ], - "diseases": "['Africa', 'Contraception', 'Intrauterine Devices', 'Pilot Study']", - "diseases_list": [ - "Africa", - "Contraception", - "Intrauterine Devices", - "Pilot Study" - ], - "enrollment": "115.0", - "inclusion_criteria": "inclusion criteria: \n\n Primary inclusion criteria: \n\n Ages 18-45 attending prenatal care \n\n Greater than 34 weeks estimated gestational age \n\n Desire to use the CuT380A-IUCD for contraception postpartum \n\n Plan to stay in the area for at least 5 months postpartum \n\n If HIV+ the women must be WHO Clinical Stage 1 or 2, or known to be clinically well on antiretroviral therapy as documented in their health passport \n\n No prior cesarean delivery \n\n No treatment for pelvic inflammatory disease within 3 months prior to pregnancy \n\n No known uterine anomalies \n\n No known pelvic tuberculosis \n\n No known genital tract cancer \n\n No known allergy to copper \n\n No known history of ectopic pregnancy within 3 months prior to pregnancy. \n\n No evidence of clinical anemia as assessed by a clinician at enrollment \n\n Any other condition a clinician feels should preclude the woman from receiving the IUCD 10-minutes to 48 hours after delivery \n\n Secondary Eligibility Criteria \n\n Vaginal delivery within the last 48 hours \n\n No postpartum hemorrhage documented by the delivering clinician \n\n Not known to have ruptured membranes for greater than 24 hours prior to delivery \n\n No infection diagnosed by a clinician \n\n No fever of greater than 38\u00b0 during labour or delivery \n\n Any other condition which a clinician feels precludes the woman from receiving the IUCD 10 minutes to 48 hours after delivery. \n\n ", - "exclusion_criteria": ": \n\n prior cesarean section \n\n fever during labor and delivery \n\n AIDS, not well on antiretroviral therapy \n\n genital tuberculosis \n\n known uterine abnormalities or genital tract cancer \n\n history of ectopic pregnancy within 3 months of current pregnancy", - "brief_summary": "The purpose of this non-blinded randomized clinical trial is to pilot the design of a randomized clinical trial to be conducted in Malawi to investigate immediate postpartum insertion of the Copper T380 intrauterine contraceptive device (CuT380A-IUCD) compared to placement at the 6-week postpartum visit.~The investigators hypothesize that it will be feasible to enroll 140 women into this study, and that women will find the 10 minute to 48 hour time frame for IUCD placement acceptable.", - "NCTID": "NCT01175161" - }, - { - "brief_title": "Efficacy of Letrozole and CC Alone in an IUI Program in Cases With Surgically Treated Minimal to Mild Endometriosis", - "phase": "", - "drugs": "['Letrozole/IUI', 'CC/IUI']", - "drugs_list": [ - "Letrozole/IUI", - "CC/IUI" - ], - "diseases": "['Endometriosis']", - "diseases_list": [ - "Endometriosis" - ], - "enrollment": "136.0", - "inclusion_criteria": "inclusion criteria: \n\n Patient with minimal-mild endometriosis recently treated by laparoscopy with a waiting period of 6 to 12 months following the procedure \n\n No other infertility factors. \n\n Normal serum basal hormone levels as well as documented ovulation \n\n ", - "exclusion_criteria": ": \n\n Moderate or severe endometriosis \n\n Dense adnexal and/or ovarian adhesions due to pelvic inflammatory disease or previous pelvic surgery \n\n Age more than 36 years, BMI more than 30 kg/m2 \n\n women with a previous pregnancy", - "brief_summary": "To evaluate pregnancy rates with letrozole and CC alone in an IUI program for women with recently surgically treated minimal to mild endometriosis.", - "NCTID": "NCT01334762" - }, - { - "brief_title": "Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis", - "phase": "", - "drugs": "['CollaGUARD']", - "drugs_list": [ - "CollaGUARD" - ], - "diseases": "['Hysteroscopic Adhesiolysis']", - "diseases_list": [ - "Hysteroscopic Adhesiolysis" - ], - "enrollment": "9.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosed with intrauterine adhesions and found eligible for hysteroscopic adhesiolysis \n\n Willing to use additional contraception throughout study \n\n ", - "exclusion_criteria": ": \n\n Be pregnant or having a suspected molar pregnancy, lactating, or planning to become pregnant at any time during the study \n\n Has suffered or currently suffers from a gynaecological malignancy \n\n Has undergone a previous hysteroscopic surgery (such as removal of fibroids)", - "brief_summary": "Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis.", - "NCTID": "NCT02348541" - }, - { - "brief_title": "A Pilot Study of Early Postpartum Intrauterine Contraception", - "phase": "Phase 4", - "drugs": "['Levonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS), 52 Mg, 5 Year Duration']", - "drugs_list": [ - "Levonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS)", - "52 Mg", - "5 Year Duration" - ], - "diseases": "['Unplanned Pregnancy']", - "diseases_list": [ - "Unplanned Pregnancy" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Currently pregnant with a single gestation of at least 27 completed weeks estimated gestational age, with no complications of pregnancy including, but not limited to, preeclampsia, non-gestational diabetes, anemia. \n\n Desires to use intrauterine contraception (IUD) after delivery \n\n Anticipates having a vaginal delivery \n\n No intention to leave the area 7 months after enrollment \n\n Able to consent to participate in the study in English \n\n Has no known uterine anomalies \n\n Has no allergies to any components of the intrauterine contraception \n\n ", - "exclusion_criteria": ": \n\n Prior cesarean delivery \n\n Having been treated for pelvic inflammatory disease within 3 months prior to the start of the pregnancy \n\n Allergic to betadine \n\n Allergy to lidocaine \n\n Medical or personal conditions which in the judgment of study staff contradict participation in the study \n\n Any contraindications to use of the levonorgestrel-releasing intrauterine contraceptive system which includes: known or suspected breast carcinoma, acute liver disease or liver tumor, history of ectopic pregnancy, cervical cancer or carcinoma in situ \n\n After enrollment, and after delivery of the infant but before IUD insertion subjects will be excluded by checking with the attending obstetric physician and/or obstetric medical chart for the following: \n\n Endometritis or chorioamnionitis during the intrapartum period \n\n Membranes ruptured for greater than 24 hours prior to delivery \n\n Fever greater than or equal to 38C \n\n The need to use additional medications other than pitocin and/or misoprostol to control postpartum bleeding", - "brief_summary": "This is a prospective clinical trial of ultrasound guided intrauterine contraception insertion 10 minutes - 48 hours after vaginal delivery of single infant. A six month follow-up will entail three follow-up visits; 4-6 weeks, 3 months, and 6 months.~The objective of this study is to measure intrauterine device (IUD) expulsion and the feasibility of conducting a future clinical trial to evaluate placement of the levonorgestrel-releasing intrauterine contraceptive 10 minutes - 48 hours postpartum.", - "NCTID": "NCT00997932" - }, - { - "brief_title": "Long Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure", - "phase": "", - "drugs": "['Purse string closure technique', 'Continuously locked closure technique']", - "drugs_list": [ - "Purse string closure technique", - "Continuously locked closure technique" - ], - "diseases": "['Cesarean Section; Complications', 'Placenta Previa', 'Placenta Accreta']", - "diseases_list": [ - "Cesarean Section; Complications", - "Placenta Previa", - "Placenta Accreta" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Singleton pregnancy \n\n Term (> 37 weeks) pregnancy \n\n Cervical dilatation < 4 cm \n\n Kerr incision \n\n Age > 18 years old \n\n ", - "exclusion_criteria": ": \n\n Being in active phase of labor \n\n Emergency situations (fetal distress, cord prolapse, placental abruption,severe pre-eclampsia, eclampsia, placenta previa, vasa previa ) \n\n Having a history of uterine surgery (myomectomy, hysterotomy) other than CS \n\n Extension of Kerr incision \n\n Multiple pregnancy \n\n Maternal diabetes mellitus \n\n Maternal connective tissue disease \n\n Uterine malformation \n\n Uterine fibroids on Kerr incision line \n\n Chorioamnionitis", - "brief_summary": "Cesarean section (C/S) is an operation most commonly performed in Obstetrics and Gynecology Clinics. Complications related with incomplete healing of Kerr uterine incision after C/S (adhesions, separation (dehiscence), endometritis, endometriosis, anomalous placentation in subsequent pregnancies, incomplete or complete uterine rupture in subsequent pregnancies, ...) are very important issues. Classically Kerr incision is repaired with continuous locked suturing. Purse string suturing of Kerr incision may reduce the size of the incision and in turn may reduce short and long term complications. For this reason, the investigators aimed to compare two closure techniques.", - "NCTID": "NCT01289262" - }, - { - "brief_title": "Extended Clomiphene Citrate Regimen in Women With Polycystic Ovary Syndrome", - "phase": "Phase 2; Phase 3", - "drugs": "['clomiphene citrate', 'laparoscopic ovarian drilling (LOD)']", - "drugs_list": [ - "clomiphene citrate", - "laparoscopic ovarian drilling (LOD)" - ], - "diseases": "['Infertility']", - "diseases_list": [ - "Infertility" - ], - "enrollment": "160.0", - "inclusion_criteria": "inclusion criteria: \n\n Age: between 18-35 years \n\n Period of infertility > 2 years \n\n Serum level of FSH <10 U/L in the early follicular phase \n\n All women were CC-resistant PCOS, as they failed to ovulate with a dose of CC of 150 mg/day for 5 days per cycle for at least three consecutive cycles \n\n All women had patent Fallopian tubes proved by hysterosalpingography or laparoscopy and their partners satisfied the normal parameters of semen analysis according to the modified WHO criteria \n\n ", - "exclusion_criteria": ": \n\n Infertility due to causes other than CC- resistant PCOS or due to combined factors \n\n Body mass index (BMI) \u226535 Kg/m\u00b2 \n\n The use of metformin, gonadotropins, hormonal contraception or diet regimen within the last 6 months \n\n Women with congenital adrenal hyperplasia, hyperprolactinaemia or abnormal thyroid function \n\n Hypersensitivity or contraindications to Letrozole or clomiphene treatment \n\n Previous LOD", - "brief_summary": "One hundred and thirty six anovulatory women with CC-resistant PCOS were scheduled randomly into two equal groups. Group A (n=68); received CC (100 mg/day from cycle day 3 for 10 days) for up to six cycles. Group B (n=68) underwent LOD and followed up for 6 months. The primary outcome was the ovulation rate in each group; secondary outcomes were midcycle endometrial thickness and serum estradiol, midluteal serum progesterone, and the rates of clinical pregnancy and abortion.", - "NCTID": "NCT02381184" - }, - { - "brief_title": "Letrozole Versus Clomiphene Citrate for Ovulation Induction in Women With Poly Cystic Ovary Syndrome ( PCOS )", - "phase": "Phase 2", - "drugs": "['Letrozole', 'Clomiphene citrate', 'hcg hormone']", - "drugs_list": [ - "Letrozole", - "Clomiphene citrate", - "hcg hormone" - ], - "diseases": "['Anovulation', 'Polycystic Ovary Syndrome']", - "diseases_list": [ - "Anovulation", - "Polycystic Ovary Syndrome" - ], - "enrollment": "110.0", - "inclusion_criteria": "inclusion criteria: \n\n Age between 20-35 \n\n Primary or secondary infertility \n\n Patients diagnosed as PCOs according to Rotterdam criteria (Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group.,2003) \n\n ", - "exclusion_criteria": ": \n\n Any patients have any causes of infertility other than which mentioned in the inclusion criteria as: \n\n Hyperprolactinemia. \n\n Male factor of infertility. \n\n WHO Guidelines 2010 for Normal seminal fluid analysis : \n\n Volume> 1.5 ml \n\n ph 7.2 to 8.0 \n\n Liquefaction time 20 to 30 min \n\n Sperms concentration >15 million/ml \n\n Total motility 40%(Progressive motility + non progressive motility) \n\n Progressive motility 32% \n\n Morphology > 4% normal forms \n\n Thyroid dysfunction. \n\n Diabetes Mellitus. \n\n Known or suspicious tubal factor infertility by HSG or laparoscope. \n\n Endometrioses or pelvic inflammatory diseases .", - "brief_summary": "110 infertile women diagnosed as polycystic ovary syndrome (PCOS) at the age group of 20-35 distributed randomly :~55 women will receive letrozole 2.5mg twice daily orally from the 2nd day to the 6thday of the cycle for three successive cycles.~55 women will receive clomiphene citrate 50 mg twice daily orally from the 2nd day to the 6thday of the cycle for three successive cycles.~Patients will be subjected to:~Complete history taking:~Details about name, age~Menstrual history with determination of menarche~Amenorrhea or oligomenorrhea , Regularity of the cycle~History of endocrine disease.~History of previous operations.~Physical examination:~General examination:~With special concern to:~--Acne.~--Hirsutism .~--Weight.~--Height~--BMI was determined :~Wt. in kg \u0640\u0640\u0640\u0640\u0640\u0640\u0640\u0640\u0640\u0640\u0640\u0640\u0640\u0640\u0640\u0640\u0640\u0640\u0640 =~) Height in m)2~- Abdominal examination :~for scar of previous pelvic or abdominal operations .~Pelvic examination :~vaginal examination for enlarged cystic ovaries.~ultrasound for diagnosis of pcos.~PARAMETERS:~(1) rate of ovulation (primary parameter). (2) serum progesterone level on day 21. (3) number of mature follicles produced per cycle. (4) mean endometrial thickness. (6) chemical pregnancy. (7) ongoing pregnancy", - "NCTID": "NCT02551367" - }, - { - "brief_title": "GnRH-a and Pregnancy Rate in In Vitro Fertilization (IVF) Cycles.", - "phase": "", - "drugs": "['Leuprolide', 'IVF']", - "drugs_list": [ - "Leuprolide", - "IVF" - ], - "diseases": "['Endometriosis', 'Infertility']", - "diseases_list": [ - "Endometriosis", - "Infertility" - ], - "enrollment": "180.0", - "inclusion_criteria": "inclusion criteria: \n\n Infertility \n\n Mild endometriosis (until stage II) \n\n ", - "exclusion_criteria": ": \n\n ovarian endometrioma > 2 cm \n\n FSH > 12 mIU/ml \n\n Mail factor infertility", - "brief_summary": "The investigators attempted to establish a rationale for the Gonadotropin Releasing Hormone-agonist (GnRH-a) administration, post-laparoscopically, in women with mild endometriosis (until stage II, according to AFS) who underwent IVF-ET procedure. Since GnRH-a reduces cytokine's concentration in serum (Iwabe et al., 1998; Iwabe et al., 2003) and peritoneal fluid of women with endometriosis (Taketani et al., 1992) the investigators hypothesized that GnRH-a can reduces also cytokine's concentration in the follicular fluid and this action may improve the oocyte quality and the fertility of these women.", - "NCTID": "NCT01269125" - }, - { - "brief_title": "Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity", - "phase": "", - "drugs": "['Laparoscopic Gastric Plication']", - "drugs_list": [ - "Laparoscopic Gastric Plication" - ], - "diseases": "['Morbid Obesity']", - "diseases_list": [ - "Morbid Obesity" - ], - "enrollment": "35.0", - "inclusion_criteria": "inclusion criteria: \n\n Age: 18 - 60 years \n\n BMI 35-39.9 kg/m2 with one or more severe co-morbid conditions or BMI 40-55 kg/m2 \n\n Willingness to comply with dietary restrictions required by the protocol \n\n History of obesity for at least 5 years \n\n History of at least 6 months of documented failures with traditional non-surgical weight loss methods \n\n Willingness to follow protocol requirements which include: signing the informed consent form, completing routine follow-up visits for the study duration, and completing all pre- and post-operative laboratory and diagnostics tests in addition to the quality of life questionnaire \n\n If female with childbearing potential, using an appropriate form of contraception \n\n ", - "exclusion_criteria": ": \n\n Age less than 18, age greater than 60 \n\n Pregnancy \n\n History of major depressive disorder or psychosis \n\n Previous bariatric surgery or previous gastric surgery \n\n Presence of achalasia \n\n Any condition that, in the judgment of the investigator, would place a subject at undue risk, or could potentially compromise the results or interpretation of the study", - "brief_summary": "The purpose of this study is to collect data prospectively on the safety and efficacy of the Laparoscopic Gastric Plication operation for patients with Severe or Morbid Obesity.~The 95% confidence interval for average percentage of weight loss and body mass index will be computed at 6 months, one year and then annually. Analysis of comorbid conditions changes, quality of life and adverse events will be performed. With 50 subjects in the study, limited power is expected and no formal hypothesis testing will be performed.", - "NCTID": "NCT01207609" - }, - { - "brief_title": "The Effect of Pre-washing the Insemination Catheter on Pregnancy Outcome", - "phase": "", - "drugs": "['washing the insemination catheter with sperm washing media']", - "drugs_list": [ - "washing the insemination catheter with sperm washing media" - ], - "diseases": "['Infertility', 'Pregnancy']", - "diseases_list": [ - "Infertility", - "Pregnancy" - ], - "enrollment": "450.0", - "inclusion_criteria": "inclusion criteria: \n\n Infertile women age ranges from 18 to 40 years at the time of treatment at the MUHC reproductive centre. \n\n Patients undergoing IUI. \n\n Fresh and frozen sperm treatment cycles \n\n Hormone induced and natural cycle (no hormonal stimulation). \n\n Patients speaking English or/and French. \n\n Patients able to consent. \n\n ", - "exclusion_criteria": ": \n\n Patients younger than 18 years or older than 40 years of age. \n\n Patients undergoing ovarian stimulation without IUI. \n\n Patients who have been recruited in our study in a previous IUI cycle. \n\n Patients who don't speak English or French. \n\n Patients who are not able or refuse to consent. \n\n Patient who are recruited in a different IUI research study.", - "brief_summary": "The investigators hypothesize that washing the insemination catheter prior to performing the IUI (intrauterine insemination) will improve the pregnancy outcome in IUI cycles when compared to controls (without pre-washing the catheter).~Catheter washing is performed routinely before embryo transfer, however it is not done for IUI catheters. Therefore no data is available on applying the technique to IUI catheters prior to insemination.", - "NCTID": "NCT02445092" - }, - { - "brief_title": "Proportion of Hysterectomy After Female Sterilization", - "phase": "", - "drugs": "['Hysteroscopic device placement including Essure (ESS305, BAY1454032)', 'Tubal ligation']", - "drugs_list": [ - "Hysteroscopic device placement including Essure (ESS305", - "BAY1454032)", - "Tubal ligation" - ], - "diseases": "['Hysterectomy']", - "diseases_list": [ - "Hysterectomy" - ], - "enrollment": "10578.0", - "inclusion_criteria": "inclusion criteria: \n\n Age: 18 to 49 years at index date \n\n Gender: Female \n\n Diagnosis: Women who underwent hysteroscopic device sterilization procedure \n\n Diagnosis: Women who underwent tubal ligation sterilization procedure (includes laparoscopic tubal ligation), and salpingectomy \n\n ", - "exclusion_criteria": ": \n\n Patients undergoing in-vitro fertilization (IVF) procedures \n\n Embryo transfer, intrauterine \n\n Follicle puncture for oocyte retrieval, any method", - "brief_summary": "The objective of this study is to describe the proportion of hysterectomy in patients that had undergone sterilization through hysteroscopic device placement and the patients that had undergone sterilization through tubal ligation.", - "NCTID": "NCT02532361" - }, - { - "brief_title": "Sleeve Gastrectomy Versus Gastric Bypass for Private Pay Patients Seeking Obesity Surgery", - "phase": "", - "drugs": "['Laparoscopic Sleeve Gastrectomy', 'Laparoscopic Gastric Bypass']", - "drugs_list": [ - "Laparoscopic Sleeve Gastrectomy", - "Laparoscopic Gastric Bypass" - ], - "diseases": "['Morbid Obesity']", - "diseases_list": [ - "Morbid Obesity" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n The last 800 consecutive patients in the surgical practice of Drake Bellanger and Andrew Hargroder who had a laparoscopic sleeve gastrectomy. \n\n The last 800 consecutive patients in the surgical practice of Drake Bellanger and Andrew Hargroder who had a laparoscopic gastric bypass. \n\n ", - "exclusion_criteria": ": \n\n Subjects having any other obesity surgical procedure", - "brief_summary": "The purpose of this study is to determine laparoscopic sleeve gastrectomy is a safer surgery than the gastric bypass, gives similar weight losses and that the safety of gastric in private pay patients versus insurance patients will be similar. This is a retrospective chart review of intervention charts.", - "NCTID": "NCT01063959" - }, - { - "brief_title": "Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass", - "phase": "", - "drugs": "['Laparoscopic sleeve gastrectomy', 'Laparoscopic Roux-en-Y gastric bypass']", - "drugs_list": [ - "Laparoscopic sleeve gastrectomy", - "Laparoscopic Roux-en-Y gastric bypass" - ], - "diseases": "['Morbid Obesity']", - "diseases_list": [ - "Morbid Obesity" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n BMI >40 and < 60 kg/m2 \n\n No contraindication to any of the procedures \n\n No contraindication to general anesthesia \n\n No known addiction \n\n Patient able to provide informed consent \n\n ", - "exclusion_criteria": ": \n\n Contraindication to general anesthesia \n\n Known psychiatric pathology \n\n Pregnancy \n\n Previous major digestive surgery \n\n Immunosuppressive treatment including corticoids \n\n Coagulopathy (INR>1.5) or platelets < 50 000/\u00b5l \n\n Anemia (Hb<10g/dl) \n\n Severe comorbidity \n\n Malabsorptive disease or gastro-intestinal disease \n\n Myocardial infarction in previous year, angina, cardiac failure", - "brief_summary": "Prospective randomized clinical trial aiming to compare laparoscopic Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) with primary outcome on excess weight loss, and secondary outcomes on nutritional status, glycolipid profile, quality of life and pain assessments.", - "NCTID": "NCT02475590" - }, - { - "brief_title": "Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)", - "phase": "", - "drugs": "['Letrozole', 'Chinese herbal medicine granules or Chinese herbal medicine granules placebo']", - "drugs_list": [ - "Letrozole", - "Chinese herbal medicine granules or Chinese herbal medicine granules placebo" - ], - "diseases": "['Polycystic Ovary Syndrome']", - "diseases_list": [ - "Polycystic Ovary Syndrome" - ], - "enrollment": "420.0", - "inclusion_criteria": "inclusion criteria \n\n Chinese women with PCOS. PCOS must have been diagnosed based on the presence of two of the following three Rotterdam criteria : (1) oligomenorrhea, anovulation; (2) hyperandrogenism; and (3) the observation of polycystic ovaries by sonography. Oligomenorrhea is defined as an intermenstrual interval >35 days or <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days. \n\n History of at least one year of infertility. \n\n Age between 20 and 40 years old. \n\n Normal semen analysis based on World Health Organization criteria (2010). The husband did not need to sign the consent form because semen analysis is part of the clinical assessment at the sites. A sperm concentration \u226515 \u00d7 106/mL and total motility \u226540% in the semen analysis of the husband was required for the woman to be included. \n\n Normal uterine cavity and at least one tube patent upon hysterosalpingography or HyCoSy. \n\n ", - "exclusion_criteria": " \n\n History of significant system diseases such as heart, lung, or kidney diseases. \n\n History of other endocrine disorders. \n\n Use of hormonal therapy, including metformin, in the past 3 months. \n\n Previous sterilization procedures (vasectomy or tubal ligation) that have been reversed.", - "brief_summary": "This is a multicenter double-blind randomized controlled trial. A total of 420 anovulatory Chinese women with PCOS will be recruited, and the randomization will be stratified by each participating site. Participants will be randomized into one of the two treatment arms: letrozole and CHMG or letrozole and CHMG placebo. CHMG or its placebo will be taken twice a day for up to six months. Letrozole (2.5 mg daily) was given on days 3-7 of the menstrual cycle after a spontaneous period or withdrawal bleeding, and the dose will be increased to 5.0 mg daily during the last three months for non-pregnant women in both groups.The aim of the present study is to determine the efficacy of combined treatment with letrozole and CHMG on improving live birth rates in infertile Chinese women with PCOS. Our hypothesis is that the combination of letrozole and CHMG is more likely to increase the ovulation rate and decrease the miscarriage rate and result in a higher live birth rate in PCOS women than letrozole alone.", - "NCTID": "NCT01431352" - }, - { - "brief_title": "Resolution of Comorbidities, Safety and Efficacy of Greater Curvature Plication in Obese Patients.", - "phase": "", - "drugs": "['Laparoscopic Greater Curvature Plication']", - "drugs_list": [ - "Laparoscopic Greater Curvature Plication" - ], - "diseases": "['Obesity']", - "diseases_list": [ - "Obesity" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject is willing to give consent and comply with evaluation and treatment schedule; \n\n 18 to 65 years of age (inclusive); \n\n Have a BMI > 27 with one or more significant co-morbid medical conditions which are generally expected to be improved, reversed, or resolved by weight loss. These conditions may include but are not be limited to - \n\n Hyperlipidemia \n\n Type 2 diabetes \n\n Mild obstructive sleep apnea \n\n Hypertension \n\n Osteoarthritis of the hip or knee \n\n Agree to refrain from any type of weight-loss drug (prescription or OTC) or elective procedure that would affect body weight for the duration of the trial; \n\n HbA1C < 11% \n\n For subjects who have Type 2 diabetes, the anti-diabetic medication regimen is no more complex than oral metformin plus one oral sulfonylurea plus once daily insulin injection. \n\n Ability to self pay for the procedure and follow up. \n\n ", - "exclusion_criteria": ": \n\n Previous malabsorptive or restrictive procedures performed for the treatment of obesity; \n\n Scheduled concurrent surgical procedure, with the exception of SOC liver biopsy; \n\n Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery; \n\n Any condition which precludes compliance with the study; \n\n History or presence of pre-existing autoimmune connective tissue disease \n\n Use of prescription or over the counter weight reduction medications or supplements within thirty days of the Screening Visit or the duration of study participation. \n\n Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression requiring > 2 medications, or history of suicide attempts. Any condition which places the subject at undue risk for the procedure (surgeon's discretion).", - "brief_summary": "Various gastric restrictive procedures have evolved over the years but abandoned due to poor long term weight loss, food intolerance or severe gastroesophageal reflux. Laparoscopic gastric plication or laparoscopic greater curvature placation ( LGCP) has recently been done as an alternative to the other restrictive procedures. But the short and long term safety and efficacy outcomes of LGCP is not well documented in current literature. American society of metabolic and bariatric surgery ( ASMBS) guidelines state that LGCP procedures should be considered investigational at this time and should be performed under a study protocol with third party oversight (e.g. IRB) to ensure continuous evaluation of patient safety and to review adverse events and outcomes.~The objective of this study will be to demonstrate feasibility , short term and long term safety and efficacy of LGCP . This will be done by achieving gastric restriction by infolding of stomach and thereby achieving good weight loss .", - "NCTID": "NCT01512940" - }, - { - "brief_title": "Regional Fat Depots and Insulin Resistance", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Obesity', 'Insulin Resistance', 'Diabetes Mellitus Type 2']", - "diseases_list": [ - "Obesity", - "Insulin Resistance", - "Diabetes Mellitus Type 2" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n No major organ disease \n\n Fasting blood glucose < 126 mg/dL \n\n BMI 25-35 kg/m2 \n\n Nonpregnant/nonlactating \n\n ", - "exclusion_criteria": ": \n\n pregnancy/lactation \n\n major organ disease \n\n drugs that influence insulin resistance \n\n unstable body weight or active weight loss program \n\n outside BMI range or age range \n\n diabetic by fasting glucose criteria 126 mg/dL or higher", - "brief_summary": "The biological basis for insulin resistance associated with obesity is unknown. By studying equally-overweight/obese individuals who are either insulin resistant or insulin sensitive, the investigators will compare characteristics of fat tissue to test several hypotheses: 1) impaired differentiation and fat storage in the subcutaneous fat depot characterize insulin resistant individuals, who have, as a result, fat in other tissues like liver and muscle, as well as more fat circulating in the blood; 2) inflammation is greater in visceral and/or subcutaneous adipose tissue depots in insulin resistant individuals as compared with insulin sensitive individuals.", - "NCTID": "NCT01336777" - }, - { - "brief_title": "The Effects of Letrozole And Clomiphene Citrate For Induction of Ovulation In Polycystic Ovarian Syndrome(PCOS)", - "phase": "Phase 3", - "drugs": "['Letrozole']", - "drugs_list": [ - "Letrozole" - ], - "diseases": "['Polycystic Ovarian Syndrome']", - "diseases_list": [ - "Polycystic Ovarian Syndrome" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria \n\n Age > 18 years but < 40 years old \n\n Was diagnosed PCOS \n\n Normal husband's seminal fluid analysis (SFA) \n\n ", - "exclusion_criteria": " : \n\n Not having medical problems eg- renal disease, tyhroid disorder, hyperprolactinemia, liver disease. \n\n Other causes of anovulatory infertility", - "brief_summary": "As both medications i.e. CC and letrozole have been shown to be effective in inducing ovulation in PCOS patients, this study was performed in order to evaluate which regime (whether CC or letrozole) is the best to be used as the first line treatment for PCOS patients with infertility for local population. The best regime will therefore could be included in the protocol of management of infertility patients with PCOS so that the quality of patients' care could be improved.", - "NCTID": "NCT01577017" - }, - { - "brief_title": "Controlled Release of Oxycodone 10 mg In Pre-Medication For The Post Operative Analgesia In Elective Laparoscopic Bilateral Inguinal Hernia And Elective Laparoscopic Cholecystectomy", - "phase": "Phase 4", - "drugs": "['Oxycodone 10 mg']", - "drugs_list": [ - "Oxycodone 10 mg" - ], - "diseases": "['Elective Laproscopic Bilateral Inguinal Hernia', 'Elective Laproscopic Cholecystectomy']", - "diseases_list": [ - "Elective Laproscopic Bilateral Inguinal Hernia", - "Elective Laproscopic Cholecystectomy" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Local ethic committee approval \n\n Written informed consent \n\n ASA physical status I-III, scheduled for elective laparoscopic cholecystectomy and elective laparoscopic BIH \n\n ", - "exclusion_criteria": ": \n\n Difficulty in communication \n\n Allergy to oxycodone and/or morphine \n\n Allergy to local anesthetic \n\n History of alcohol and substance abuse \n\n Treated depression \n\n Chronic use of opioid or tramadol or NSAIDS \n\n Pregnancy \n\n Obstructive sleep apnea \n\n Anticipated fiber optic intubation \n\n Severe hepatic or renal impairment \n\n Weight <50 kg or > 100 kg \n\n Conversion to laparotomy \n\n Patient extubated in PACU. \n\n Any prior abdominal surgery", - "brief_summary": "A Prospective Double Blind RCT: Controlled Release Oxycodone 10 mg On a 12 h Dosing Schedule Started With The Premedication ,Placebo Controlled Study,On Post Operative Analgesia Management in Laparoscopic Cholecystectomy and Laparoscopic Bilateral Inguinal Hernia (BIH).~CRO is indicated for the management of moderate to severe pain when a continuous,around the clock analgesic is needed for an extended period of time.Its safety and efficacy in the first 12-24 hours post operative has not been established.", - "NCTID": "NCT00480142" - }, - { - "brief_title": "Establishing Visualization Grading Scale on LESS Cholecystectomy", - "phase": "", - "drugs": "['Cholecystectomy visualization']", - "drugs_list": [ - "Cholecystectomy visualization" - ], - "diseases": "['Cholecystitis']", - "diseases_list": [ - "Cholecystitis" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Signed informed consent \n\n 18 years of age and older \n\n All patients deemed to have a clinical and surgical indication to undergo a LESS cholecystectomy \n\n ", - "exclusion_criteria": ": \n\n Pregnancy \n\n Breastfeeding \n\n BMI>35 \n\n Serious comorbidities precluding a LESS cholecystectomy \n\n Known or suspected neuromuscular disorders impairing neuromuscular function \n\n Allergies to muscle relaxants, anesthetics or narcotics utilized for this study \n\n A (family) history of malignant hyperthermia \n\n A contraindication for neostigmine administration \n\n Chronic opioid use \n\n Prolonged QT syndrome \n\n Creatinine >2.0", - "brief_summary": "Essential to laparoscopic operations is adequate visualization. Unfortunately there is no grading system to assess the degree or quality of visualization. The primary objective of the project is to develop a laparoscopic visualization scoring system. We also intend to investigate the effects of neuromuscular blockade agents on visualization.", - "NCTID": "NCT02264444" - }, - { - "brief_title": "An Adipocyte-Driven Mechanism For Weight Regain After Weight Loss: The Yo-Yo Effect", - "phase": "", - "drugs": "['Meal replacement diet using Modifast', 'Normal diet combined with Modifast diet']", - "drugs_list": [ - "Meal replacement diet using Modifast", - "Normal diet combined with Modifast diet" - ], - "diseases": "['Obesity', 'Weight Loss', 'Diet']", - "diseases_list": [ - "Obesity", - "Weight Loss", - "Diet" - ], - "enrollment": "58.0", - "inclusion_criteria": "inclusion criteria: \n\n Age (years): 20-65 \n\n Body Mass Index (kg/m2): 28-35 \n\n Non-smokers \n\n ", - "exclusion_criteria": ": \n\n Subjects using prescription medication, or suffering from diseases or conditions that might influence the outcome of the study: this concerns diseases/medication that influence body weight regulation (malabsorption, untreated hypo/hyperthyroidism, eating disorders, systemic use of steroids, etc.) and obesity-related cardiovascular risk factors (heart disease, systolic and diastolic blood pressures > 160/100 mmHg, blood glucose > 6.1 mmol L-1, blood cholesterol > 7 mmol L-1, blood triglycerides > 3 mmol L-1) \n\n marked alcohol consumption > 21 alcoholic units week-1 (male), or >14 alcoholic units week-1 (female) \n\n planned major changes in physical activity during the study to an extent that might interfere with the study outcome as judged by the investigator; \n\n blood donation within the past 2 months prior to the study \n\n weight change of >3 kg within 2 months prior to the study \n\n psychiatric disease (based on medical history only) \n\n pregnant or lactating women, or women planning to become pregnant within the next 12 months \n\n surgically treated obesity \n\n participation in other clinical studies within the last 3 months \n\n drug abuse (based on clinical judgment) \n\n unable to give informed consent \n\n unable to engage in a low-calorie diet \n\n unable to lose more then 8% of body weight after weight-loss period \n\n following a special diet (vegetarian, Atkins or other).", - "brief_summary": "Almost half of the Dutch population is currently characterized by overweight and obesity. Losing weight is not the problem in obesity treatment, it is the seemingly obligatory weight regain after weight loss: the yoyo-effect. The primary objective of this study is to investigate the association between the weight-loss-induced cellular stress response and the rate of weight regain. The secondary objective is to investigate the differences in cellular stress response and weight regain after rapid and slow weight loss. To investigate this, subjects will receive meal replacements replacing either all or part of the daily meals during the intervention period. THe first group will consume 500 kcal/d diet for 5 weeks while the second group consumes a 1250 kcal/d diet for 3 months, both followed by 1 week normalization and a 2 week strict weight maintenance diet. During the 9-month follow-up period subjects will receive dietary advice according to the Dutch recommendations for healthy eating. The association between the amount of weight regain after the weight loss period and changes in adipokines, parameters of adipocyte metabolism, in vivo adipose tissue metabolism, adipocyte extracellular matrix gene expression profiles, adipocyte stress protein expression and gene polymorphisms in selected genes.", - "NCTID": "NCT01559415" - }, - { - "brief_title": "Proteomics Study of Gastric Bypass Surgery to Treat Type 2 Diabetes Mellitus", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Type 2 Diabetes']", - "diseases_list": [ - "Type 2 Diabetes" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n patients diagnosed as type 2 diabetes are planning to have Roux-en-Y gastric bypass \n\n age:18-65yr \n\n HbAlc>8% \n\n ", - "exclusion_criteria": ": \n\n diabetes (applies for control patients) \n\n chronic inflammatory disease \n\n malignant disease \n\n pregnancy \n\n prior gastric, duodenal, proximal jejunal surgery or pancreas resection \n\n current use of thiazolidinediones \n\n treatment with incretin mimetics or DPP IV inhibitors in the prior 3 months \n\n HbAlc<8% \n\n any condition felt by the investigator to interfere with ability to complete the study", - "brief_summary": "The purpose of this study is to reveal the key proteins involved in gastric bypassing surgery which may effect the decreased glucose in type 2 diabetes patietns, and evaluate standard remission rate as well as cost-benefit of gastric bypassing surgery for type 2 diabetes mellitus patients in China.", - "NCTID": "NCT01870713" - }, - { - "brief_title": "Role of Emotional Freedom Techniques in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy", - "phase": "", - "drugs": "['EFTs (emotional freedom techniques)', 'Tab. Midazolam 7.5 mg', 'Inj. Midazolam 0.7mg/kg', 'Inj. Propofol 2.5mg/kg', 'Inj. Atracurium 0.5 mg/kg', 'Sevoflurane 2.5 vol %', 'Inj. Cefuroxime 1.5 g IV', 'Drug: Inj. Ketorolac 30 mg IV', 'Inj. Zantac 50mg IV']", - "drugs_list": [ - "EFTs (emotional freedom techniques)", - "Tab. Midazolam 7.5 mg", - "Inj. Midazolam 0.7mg/kg", - "Inj. Propofol 2.5mg/kg", - "Inj. Atracurium 0.5 mg/kg", - "Sevoflurane 2.5 vol %", - "Inj. Cefuroxime 1.5 g IV", - "Drug: Inj. Ketorolac 30 mg IV", - "Inj. Zantac 50mg IV" - ], - "diseases": "['Postoperative Nausea and Vomiting']", - "diseases_list": [ - "Postoperative Nausea and Vomiting" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients undergoing elective laparoscopic cholecystectomy for gallstone disease. \n\n Patients with age range of 25 to 55 years \n\n ", - "exclusion_criteria": ": \n\n H/O chronic illness like DM, IHD, CRF, CLD, \n\n H/O acute or chronic psychiatric or psychological illness. \n\n H/O APD (acid peptic disease) or regurgitation. \n\n H/O of any chemotherapy (cancer drugs, opioids), radiotherapy, any history of repeated infection. \n\n H/O use of hepatotoxic drugs like acetaminophen, ciprofloxacin, ATT, valproic acid etc. in last one month. \n\n H/O alcohol intake in last one month. \n\n Previous hepatobilliary surgery. \n\n Complicated cholecystectomy in which laparoscopic cholecystectomy is converted to open cholecystectomy. \n\n Patients who are given opioids in postoperative period. \n\n Patients who need epidural analgesia in postoperative period.", - "brief_summary": "In our study the investigators want to evaluate the effects of EFTs (emotional freedom techniques) for reducing incidence of PONV (Postoperative nausea and vomiting). The effects of EFTs have been quiet evident on many aspects if the incidence of PONV is reduced then it will be much valuable adjunct to postoperative management of the patients.~Our hypothesis was Emotional freedom techniques are very useful to reduce the incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy.", - "NCTID": "NCT02169856" - } - ], - "1": [ - { - "brief_title": "Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location", - "phase": "Phase 3", - "drugs": "['Methotrexate', 'Uterine Evacuation', 'Expectant Management']", - "drugs_list": [ - "Methotrexate", - "Uterine Evacuation", - "Expectant Management" - ], - "diseases": "['Persistent Pregnancy of Unknown Location', 'Ectopic Pregnancy']", - "diseases_list": [ - "Persistent Pregnancy of Unknown Location", - "Ectopic Pregnancy" - ], - "enrollment": "255.0", - "inclusion_criteria": "inclusion criteria: \n\n Female with a persisting pregnancy of unknown location: \n\n A pregnancy of unknown location is defined as a pregnancy in a woman with a positive pregnancy test but no definitive signs of pregnancy in the uterus or adnexa on ultrasound imaging. A definitive sign of gestation includes ultrasound visualization of a gestational sac with a yolk sac (with or without an embryo) in the uterus or in the adnexa. Ultrasound must be performed within 7 days prior to randomization. \n\n Persistence of hCG is defined as at least 2 serial hCG values (over 2-14 days), showing < 15% rise per day, or < 50% fall between the first and last value. \n\n Patient is hemodynamically stable, hemoglobin >10 mg/dL \n\n Greater than or 18 years of age \n\n ", - "exclusion_criteria": ": \n\n Hemodynamically unstable in need of acute treatment \n\n Most recent hCG > 5000 mIU/mL \n\n Patient obtaining care in relation to a recently completed pregnancy (delivery, spontaneous or elective abortion) \n\n Diagnosis of gestational trophoblastic disease \n\n Subject unwilling or unable to comply with study procedures \n\n Known hypersensitivity to MTX \n\n Presence of clinical contraindications for treatment with MTX \n\n Prior medical or surgical management of this gestation \n\n Subject unwilling to accept a blood transfusion", - "brief_summary": "This is a randomized controlled trial to compare three currently available management strategies for women with a persisting pregnancy of unknown location (PPUL), which makes them at-risk for ectopic pregnancy. We will recruit hemodynamically stable women with a confirmed PPUL to be randomized to one of three strategies: 1) Uterine evacuation followed by methotrexate (MTX) for some (those that have evidence of a non visualized ectopic pregnancy) 2) Empiric treatment with MTX for all 3) Expectant management. Randomization will be 1:1:1 into these three arms. After randomization, they will be followed and treated clinically as is indicated by the progression of their condition. Primary outcome measures: uneventful decline of hCG to 5 IU/mL.", - "NCTID": "NCT02152696" - }, - { - "brief_title": "Are Serum Levels of Vascular Endothelial Growth Factor a Marker for the Early Diagnosis of Ectopic Pregnancy?", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Ectopic Pregnancy']", - "diseases_list": [ - "Ectopic Pregnancy" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria:The inclusion criterion was the presence at transvaginal ultrasound of an extraovarian adnexal mass in women with a suspected ectopic pregnancy (amenorrhea, bleeding and pain) with positive test for beta-hCG. \n\n - \n\n ", - "exclusion_criteria": ":The exclusion criterion was non-tubal ectopic pregnancy (cervical, cesarean scar, ovarian, and abdominal). \n\n -", - "brief_summary": "OBJECTIVE: This study evaluated serum vascular endothelial growth factor (VEGF) concentrations in women with ectopic pregnancy (EP), abnormal intrauterine pregnancy (aIUP) and normal intrauterine pregnancy (nIUP).~METHODS: This was a prospective, case-control study comparing serum VEGF concentrations among 72 women with ectopic pregnancy (n=35), abnormal IUP (n=15) and normal IUP (n=22) matched for gestational age. For the determination of serum VEGF concentration a solid phase sandwich ELISA was used. Patients were stratified according to serum VEGF above or below 200pg/mL.~RESULTS: The serum level of VEGF was significantly higher in women with ectopic pregnancy (median 211.1 pg/mL; range 5 - 1017.0 pg/mL) than in women with normal IUP (median 5 pg/mL; range 5- 310.6 pg/mL) P < 0.0001. Serum VEGF concentrations did not show any statistically significant difference between women with aIUP (median 231.9 pg/mL range 5 - 813.7 pg /mL ) and EP (median 211.1 pg/mL range 5 - 1017.0 pg/mL). When cut-off concentrations of 200 pg/mL for VEGF were used, a nIUP could be distinguished from an unviable (EP and aIUP) with a sensitive of 53%, specificity of 90.9%, a positive predictive value of 92.9% and a negative predictive value of 46.5%..~CONCLUSIONS: Serum VEGF could not distinguish between an EP and an aIUP. However, serum VEGF concentrations above 200 pg/mL could discriminate a nIUP from an unviable pregnancy (EP or aIUP) with a PPV of 92.9%.", - "NCTID": "NCT01261026" - }, - { - "brief_title": "Two-Dose Methotrexate for Ectopic Pregnancy", - "phase": "Phase 3", - "drugs": "['Methotrexate']", - "drugs_list": [ - "Methotrexate" - ], - "diseases": "['Ectopic Pregnancy']", - "diseases_list": [ - "Ectopic Pregnancy" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Confirmed diagnosis of ectopic pregnancy via \n\n D&E without products of conception identified on frozen pathology or \n\n VABRA without products of conception identified with pathologic evaluation or \n\n Ultrasound visualization of a gestational sac in the adnexa, with definitive visualization of a yolk sac or fetal pole \n\n the subject is hemodynamically stable without signs of hemoperitoneum \n\n laparoscopy has not been performed \n\n the subject is able to return for frequent follow-up care \n\n normal renal and liver function have been documented within 2 days \n\n normal white blood count and platelet count have been documented as per laboratory standard \n\n normal chest x-ray was obtained if the subject has a history of pulmonary disease \n\n no history of allergy or sensitivity to methotrexate or any component of its formulation \n\n ", - "exclusion_criteria": ": \n\n breastfeeding \n\n laboratory evidence of immunodeficiency \n\n alcoholism or chronic liver disease \n\n the concomitant use of non-steroidal anti-inflammatory drugs \n\n blood dyscrasia such as leukopenia, thrombocytopenia, or severe anemia \n\n active pulmonary disease \n\n hepatic, renal, or hematological dysfunction \n\n adnexal mass > or = 3.5 cm \n\n presence of fetal cardiac motion \n\n active major psychiatric disorder such as major depression, bipolar disease, psychotic disorder, or drug addiction \n\n subjects unable or unwilling to comply with study procedures or illiterate", - "brief_summary": "This study examines the safety and acceptability of a novel two dose regimen of methotrexate to treat ectopic pregnancy.", - "NCTID": "NCT00194272" - }, - { - "brief_title": "Overeating Different Fats and Influence on Muscle Mass and Body Fat Accumulation", - "phase": "", - "drugs": "['PUFA-group', 'SFA-group']", - "drugs_list": [ - "PUFA-group", - "SFA-group" - ], - "diseases": "['Obesity', 'Overfeeding', 'Muscle Mass', 'Body Composition', 'Ectopic Fat']", - "diseases_list": [ - "Obesity", - "Overfeeding", - "Muscle Mass", - "Body Composition", - "Ectopic Fat" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Body mass index 25-32 \n\n ", - "exclusion_criteria": ": \n\n Type 2 diabetes \n\n Type 1 diabetes \n\n Kidney disease \n\n Liver disease \n\n Abnormal clinical chemistry at screening \n\n Intense physical exercise > 2 hours per week \n\n Use of statins or drugs affecting energy metabolism \n\n Use of extreme diets", - "brief_summary": "To investigate metabolic and molecular response to fatty acid-specific overfeeding in overweight subjects, in relation to changes in ectopic fat, lean tissue mass and insulin sensitivity", - "NCTID": "NCT02211612" - }, - { - "brief_title": "Gastric Bypass After Previous Anti-reflux Surgery", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Clinically Severe Obesity', 'Gastroesophageal Reflux Disease']", - "diseases_list": [ - "Clinically Severe Obesity", - "Gastroesophageal Reflux Disease" - ], - "enrollment": "22.0", - "inclusion_criteria": "inclusion criteria: \n\n Status post, either open or laparoscopic, primary Nissen fundoplication with all the following requirements: \n\n Met NIH criteria for bariatric surgery \n\n With functional or failed antireflux surgery (Nissen fundoplication) \n\n Laparoscopic approach for revisional surgery \n\n ", - "exclusion_criteria": ": \n\n Any other type of revisional bariatric procedure \n\n Nonstandard revisional RYGB surgery \n\n Open approach for revision surgery \n\n Missing records and/or unreachable patients with scant information for analysis", - "brief_summary": "The goal of this study is to describe the clinical presentation, indications, and operative treatment as well as assess the morbidity, mortality, and overall performance of revisional Roux-en-Y gastric bypass (RYGB) after either failed or functional antireflux surgery ARS in obese patients. With such information, we hope to determine which features might assist us in advancing our knowledge about Gastro-Esophageal Reflux Disease GERD, the best option for primary ARS, and mechanisms of failure in the obese population as well as in identifying predictors of outcome after revisional surgery in this population.", - "NCTID": "NCT01041105" - } - ], - "2": [ - { - "brief_title": "Vascular Endothelial Growth Factor Levels in Ectopic Pregnancy", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Complication Following Ectopic Pregnancy']", - "diseases_list": [ - "Complication Following Ectopic Pregnancy" - ], - "enrollment": "30.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients who suspected ectopic pregnancy \n\n ", - "exclusion_criteria": ": \n\n hemodynamically unstable patient \n\n healthy pregnancy (a healthy increase in \u00df HCG) \n\n missed abortion \n\n incomplete abortion \n\n The patient who need immediate surgical treatment", - "brief_summary": "The aim of this study is to determine plasma Vascular Endothelial Growth Factor level and change in patient with ectopic pregnancy who needs to surgical treatment.~Patient with ectopic pregnancy diagnosed and treated with medically or surgically will be included in the study. This is an observational study.The plasma Vascular Endothelial Growth Factor level will be measured first day and two day after the diagnosis of ectopic pregnancy.", - "NCTID": "NCT01601964" - }, - { - "brief_title": "Activin A and Inhibin A in Predicting Outcome of Pregnancies of Unknown Location After Assisted Reproductive Technology", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Ectopic Pregnancies']", - "diseases_list": [ - "Ectopic Pregnancies" - ], - "enrollment": "96.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with pregnancy of unknown location (PUL) diagnosed 22 - 27 days after oocyte retrieval, at first ultrasound routine control (A pregnancy of unknown location (PUL) is a term used to classify a women with a positive pregnancy test and an empty uterus with no signs of an intrauterine or extrauterine pregnancy on a transvaginal ultrasound scan.) \n\n Patients with Intrauterine pregnancy : Viable intrauterine pregnancy (IUP) An intrauterine gestational sac containing a fetal pole with visible cardiac activity \n\n Patients with Ectopic pregnancy (Tubal ectopic pregnancy): An empty endometrial cavity with: (i) an inhomogeneous adnexal mass or (ii) an empty extrauterine gestational sac seen as hyperechoic ring or (iii) an extrauterine gestational sac with a yolk sac and/or fetal pole with or without cardiac activity", - "exclusion_criteria": "", - "brief_summary": "The purpose of this study is to determine the predictive value of a single serum determination of activin A and inhibin A for the prognosis of ectopic pregnancy after in Vitro Fertilization (IVF) cycles, in both native and donated oocytes.", - "NCTID": "NCT01589016" - }, - { - "brief_title": "BHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success", - "phase": "Phase 4", - "drugs": "['Methotrexate']", - "drugs_list": [ - "Methotrexate" - ], - "diseases": "['Ectopic Pregnancy']", - "diseases_list": [ - "Ectopic Pregnancy" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n patients with ectopic pregnancy \n\n healthy \n\n hemodynamic stable \n\n first ectopic \n\n ", - "exclusion_criteria": ": \n\n hemodynamic non-stable \n\n abnormal liver or kidney function \n\n allergy reaction to MTX", - "brief_summary": "The investigators want to compeer BHCG levels after Methotrexate ( MTX). treatment for Ectopic pregnancy in days 4 and 7 after MTX. to day 10 . The hypothesis is that BHCG level in day 10 is the best indicator for treatment success , superior to day 4 and 7 . According to the investigators impression BHCG level rises in days 4 and 7 due to destruction of the trophoblast tissue , and only day 10 is an indicator for treatment success", - "NCTID": "NCT01860690" - } - ] - }, - { - "patient_id": "sigir-201527", - "patient": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", - "0": [ - { - "brief_title": "Ferric Carboxymaltose Treatment to Improve Fatigue Symptoms in Iron-deficient Non-anaemic Women of Child Bearing Age", - "phase": "Phase 4", - "drugs": "['Ferinject', 'Saline']", - "drugs_list": [ - "Ferinject", - "Saline" - ], - "diseases": "['Iron Deficiency']", - "diseases_list": [ - "Iron Deficiency" - ], - "enrollment": "294.0", - "inclusion_criteria": "inclusion criteria: \n\n Signed informed consent prior to study specific procedures. \n\n Premenopausal, regularly menstruating women. \n\n Age \u226518 years. \n\n Body weight between 50 and 90 kg. \n\n Haemoglobin \u2265115 g/L. \n\n Iron deficiency at screening defined as follows: \n\n S-ferritin level <50 ng/mL, AND, TfS <20%, OR, \n\n S-ferritin level <15 ng/mL. \n\n Serum C-reactive protein: \n\n <5 mg/L if not on oral contraception, OR, \n\n <20 mg/L if use of oral contraception. \n\n Minimum total score of 5 on the Piper Fatigue Scale (PFS) (mean of items 2 to 23). \n\n Negative pregnancy test (serum human chorionic gonadotropin (hCG) at screening. \n\n Normal levels of vitamin B12 and folic acid at screening. \n\n Adequate contraception during the study period and for 1 month following study completion. \n\n Availability and willingness to complete all study visits and procedures per protocol. \n\n ", - "exclusion_criteria": ": \n\n Haemoglobin level <115 g/L. \n\n Haemoglobinopathy. \n\n Haemochromatose. \n\n Major depressive disorder based on Patient Health Questionnaire (PHQ-9) (5 items with scores \u22652; one of which corresponds to question number 1 or 2). \n\n Any active or unstable concurrent medical condition (e.g., cancer, renal dysfunction, liver dysfunction (aspartate aminotransferase (AST); alanine aminotransferase (ALT) >3-fold upper limit), angina (Class IV). \n\n Known human immunodeficiency virus/acquired immunodeficiency syndrome, hepatitis B virus or hepatitis C virus infection. \n\n Chronic inflammatory disease (e.g., rheumatoid arthritis; inflammatory bowel disease). \n\n Documented history of clinically significant level of sleep apnoea defined as 5 or more episodes per hour of any type of apnoea. \n\n Intake of concurrent medications that could interfere with physical or mental performance (e.g., antidepressive, antihistamines, narcotic or any chemotherapeutic agents known to cause drowsiness). \n\n Important recent weight loss (>10% within the past month). \n\n Body weight <50 kg or >90 kg. \n\n Thyroid dysfunction, thyroid stimulating hormone >4 \u03bcU/mL. \n\n Intake of iron preparations 4 weeks prior to screening. \n\n Use of gestagens e.g., Implanon, Mirena, Depo-Provera for menstruation repression (see Section 7.7, Prohibited Therapy or Concomitant Treatment, page 35). \n\n Known hypersensitivity to FCM or to any other iron preparation. \n\n Pregnancy (positive hCG test at screening) or breast feeding. \n\n Participation in any other interventional trial within 4 weeks prior to screening. \n\n Inability to fully comprehend and/or perform study procedures or provide written consent in the Investigator's opinion. \n\n Subject is not using adequate contraceptive precautions during the study and for up to 1 month after the last dose of the study medication. A highly effective method of birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner. \n\n Subject previously has entered this study. \n\n Subject will not be available for follow-up assessments.", - "brief_summary": "research study of Ferric carboxymaltose to treat fatigue/exhaustion symptoms, believed to be due to iron deficiency.", - "NCTID": "NCT01110356" - }, - { - "brief_title": "Hepcidine and Iron Deficiency in Critically Ill Patients", - "phase": "", - "drugs": "['hepcidin', 'ferritin and transferrin saturation']", - "drugs_list": [ - "hepcidin", - "ferritin and transferrin saturation" - ], - "diseases": "['Anemia', 'Critical Illness', 'Hospitalized for 5 Days or More']", - "diseases_list": [ - "Anemia", - "Critical Illness", - "Hospitalized for 5 Days or More" - ], - "enrollment": "408.0", - "inclusion_criteria": "inclusion criteria: \n\n Hospitalized man/woman in reanimation unit for at least 5 days. \n\n Age \u2265 18 years old. \n\n Patient having an anaemia such as defined by the WHO (World Health Organization) (for man: Hemoglobin < 13 g/dl, for woman: Hemoglobin < 12 g/dl). \n\n Signed inform consent by the patient or a close person. \n\n Subject affiliated to a national health insurance \n\n ", - "exclusion_criteria": ": \n\n Known iron metabolism pathology (such as primitive or secondary hemochromatosis, \u2026). \n\n Chronic anaemia (Hemoglobin \u2264 10 g/dl for more than 3 months). \n\n Current chemotherapy. \n\n Patient having an organ transplant \n\n Expected survival < 28 days post Intensive Care Unit discharge. \n\n Pregnancy \n\n Patient deprived of freedom, by judicial or administrative order. \n\n Major protected by the law. \n\n Contra-indication to the injectable iron treatment (allergy to ferric carboxymaltose, infection derivates (bacteriamy < 48 hours) untreated). \n\n Non speaking French patient, or patient unable to answer a questionnaire because of any neurologic disorder (stroke, brain trauma\u2026.).", - "brief_summary": "Anaemia is very frequent among critically ill patients, concerning more than 60 % of them at admission and more than 80% at intensive care unit discharge. Iron deficiency is also frequent at admission, with prevalence around 25 to 40%. During their stay in Intensive Care Unit, critically ill patients are exposed to repeated blood samples and to other blood losses (daily blood loss has been evaluated to be as high as 128 ml/day in median), this leads to direct iron loss. Prevalence of iron deficiency may thus be very important at Intensive Care Unit discharge. However, iron deficiency diagnosis is complicated in these patients, since inflammation induces an increase in plasma ferritin levels and a decrease in transferrin saturation, the two usual markers of iron deficiency. As a consequence, iron deficiency is usely under-diagnosed in these patients. Treatment of iron deficiency may be indicated to correct anaemia but also to improve patients fatigue and muscular weakness. The characterization of iron metabolism regulation by the hormone hepcidin opened new ways for the understanding and the follow-up of these complex clinical situations (combining inflammation and iron deficiency). Indeed, iron deficiency is associated with a decrease in hepcidin synthesis, while iron overload induces hepcidin synthesis. Furthermore, low hepcidin levels are required to mobilize iron from stores. Hepcidin has thus be proposed as a marker of iron deficiency in critically ill patients. To date, standard immunological methods of hepcidin quantitation are only proposed in the reasearch setting and could not be proposed in the clinical setting because it is too expensive. New approaches for hepcidin quantification, based on mass spectrometry are proposed and may be routinely implemented. We make the hypothesis that treating iron deficiency in critically ill anemic patients, diagnosed by hepcidin quantification, may improve the post-Intensive Care Unit rehabilitation, and may thus reduce post-Intensive Care Unit cost linked to hospital stay and anaemia treatment.~The aim of this study is to evaluate the medical economic interest of a new diagnostic method for iron deficiency, based on a quantitative dosage of hepcidin by mass spectrometry in critically ill anaemic patients.", - "NCTID": "NCT02276690" - }, - { - "brief_title": "Effect of Timing of Umbilical Cord Clamping on Anaemia at 8 and 12 Months and Later Neurodevelopment", - "phase": "", - "drugs": "['Early (\u226430 seconds) cord clamping', 'Delayed (\u2264180 seconds) cord clamping']", - "drugs_list": [ - "Early (\u226430 seconds) cord clamping", - "Delayed (\u2264180 seconds) cord clamping" - ], - "diseases": "['Anemia', 'Iron Deficiency', 'Neonatal Jaundice']", - "diseases_list": [ - "Anemia", - "Iron Deficiency", - "Neonatal Jaundice" - ], - "enrollment": "540.0", - "inclusion_criteria": "inclusion criteria: \n\n Late preterm or term pregnancy (gestational age 34 to 41 weeks) \n\n Vaginal delivery \n\n ", - "exclusion_criteria": ": \n\n Serious congenital malformation, syndrome or other congenital disease that can affect the outcome measures", - "brief_summary": "The investigators plan a study to randomize 540 children in Nepal to early (\u226430 seconds) or late (\u2265180 seconds) clamping of the umbilical cord at birth. The children will be followed with blood tests (hemoglobin and ferritin) at 8 and 12 months of age, and their development is evaluated by questionnaire (Ages & Stages Questionnaire ) at 12 months of age, and by testing (Bayley -III) at 18-24 months of age. By implementing the project in a country with a high proportion of anemia at one year of age (about 75%), we can reduce the number of children in the study and still achieve significant results.~Iron deficiency is a global health problem and causes anemia and impaired neurodevelopment in children. Anemia is estimated by WHO to occur among 25% of all children before school age, and the corresponding figure in Europe is 3-9 %.~By waiting 3 minutes to clamp the cord after birth, a large part of the child's blood volume remaining in the placenta is transfused over to the child's body. Research shows that the neonate's blood volume can increase by about 40% and this blood contains 3 to 4 months' supply of iron. In Sweden, we have shown that late clamping of the umbilical cord could reduce iron deficiency in children at four months of age by 90%. Globally, most countries practice early cord clamping and the child is deprived of the placental blood transfusion. The hypothesis of the study is that by delaying the clamping of the umbilical cord, anemia at 8 and 12 months will be reduced an this in turn will be beneficial for the childrens development.~The project will be implemented at Paropakar Maternity and Women 's Hospital, Kathmandu. It hosts approximately 23,000 births annually.", - "NCTID": "NCT02222805" - }, - { - "brief_title": "Assessment of Anaemia Attributable to Schistosomiasis in School Children in Kenya: Mechanisms and Effect of Treatment", - "phase": "", - "drugs": "['praziquantl, iron, ACT']", - "drugs_list": [ - "praziquantl", - "iron", - "ACT" - ], - "diseases": "['Anaemia', 'Schistosomiasis Infection', 'Malaria', 'Iron Deficiency']", - "diseases_list": [ - "Anaemia", - "Schistosomiasis Infection", - "Malaria", - "Iron Deficiency" - ], - "enrollment": "1500.0", - "inclusion_criteria": "inclusion criteria: \n\n school children between 9 to 12 year", - "exclusion_criteria": "", - "brief_summary": "The purpose of this study is to determine the extend and the nature of anemia in school children and the correlation between anemia and schistosomiasis infections, malaria infections and/or malnutrition (iron deficiency).", - "NCTID": "NCT00414479" - }, - { - "brief_title": "Pharmacokinetic Study of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin", - "phase": "Phase 4", - "drugs": "['iron sucrose injection USP']", - "drugs_list": [ - "iron sucrose injection USP" - ], - "diseases": "['Anemia']", - "diseases_list": [ - "Anemia" - ], - "enrollment": "8.0", - "inclusion_criteria": "inclusion criteria: \n\n Age between 12 and 18 \n\n History of Chronic Renal Failure requiring HD or PD \n\n Hgb 30 km from the recruitment site. \n\n Lack of consent.", - "brief_summary": "Severe anaemia is a frequent cause of admission to hospitals in tropical Africa and about 10% of such children die. In endemic countries, anaemia has multiple causes such as nutritional deficiencies, infections and haemoglobinopathies. However, Plasmodium falciparum infection is believed to be the major contributory factor to the aetiology of severe anaemia. Severe anaemia is usually treated by blood transfusion although transfusion carries the attendant risk of transmission of HIV and other blood-borne infections. Thus, there is a need to explore novel strategies to reduce the incidence of severe anaemia in high-risk groups such as children with suboptimal haemoglobin levels because these children are at increased risk of developing severe anaemia if they develop a malaria infection before their haemoglobin level has normalized. Therefore, it is proposed to study whether monthly chemoprophylaxis with sulphadoxine/pyrimethamine (S/P) given during malaria transmission season can protect Gambian children from developing severe anaemia. After receiving treatment from the hospital, 1200 children admitted to the hospital with a haematocrit of less than 21% were randomised to receive either monthly S/P or placebo during the rest of the malaria transmission season. Morbidity was monitored throughout the rainy season. Study subjects were seen at the end of the dry season to document morbidity and mortality.", - "NCTID": "NCT00131716" - }, - { - "brief_title": "Demographic, Clinical and Laboratory Characteristics of Children With Alpha Thalassemia in Northern Israel", - "phase": "", - "drugs": "['Medical records summary']", - "drugs_list": [ - "Medical records summary" - ], - "diseases": "['Thalassemia Alpha', 'Hemolytic Anemia']", - "diseases_list": [ - "Thalassemia Alpha", - "Hemolytic Anemia" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n All the patients that were studied at the pediatric hematology unit ant the Ha'Emek Medical Center \n\n ", - "exclusion_criteria": ": \n\n None", - "brief_summary": "The study intends to summarize the clinical and laboratory characteristics of children with hemolytic anemia diagnosed as having alpha thalassemia mutations.", - "NCTID": "NCT00971984" - }, - { - "brief_title": "Impact of Maternal Iron Status on Neonatal Iron Status and Auditory Brainstem Response in the Newborn", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Anemia']", - "diseases_list": [ - "Anemia" - ], - "enrollment": "144.0", - "inclusion_criteria": "inclusion criteria: \n\n Adolescents (ages 11-18 y) and their newborns will be eligible to participate if the adolescent is carrying a singleton pregnancy, does not have any preexisting medical complications (such as HIV-infection, eating disorders, hemoglobinopathies, malabsorption diseases, steroid use, substance abuse history, or taking medications known to influence iron homeostasis). \n\n ", - "exclusion_criteria": ": \n\n Individuals with pregnancy induced hypertension or elevated diastolic blood pressure (>110) will not be eligible to participate in the study. In addition, adolescents who have been previously treated for lead exposure, or those that have been identified as having elevated blood lead concentrations during childhood, will be excluded from the study. \n\n Data from infants that experience perinatal asphyxia, pathologic neonatal hyperbilirubinemia, respiratory disease, antibiotic therapy (aminoglycosides), CNS infection, sepsis, congenital or middle or external ear lesions, craniofacial anomalies, chromosomal disorders, TORCH (toxoplasmosis, other infections, rubella, cytomegalovirus infection and herpes simplex infection) or those that were clinically unstable with the first 48 h post-delivery will be excluded from ABR studies. Infants born to mothers with positive drug abuse screens at delivery will also be excluded from further study (these screens are automatically run among this age group). Infants that are identified with hearing deficits at birth using the OAE screening will be excluded from the ABR measures.", - "brief_summary": "This study aims to determine how maternal Fe status influences placental and neonatal Fe status in pregnant adolescents and to assess the impact of the Fe endowment of birth on functional outcomes as assessed by auditory brainstem responses within 48 h of delivery in neonates born to these adolescents.", - "NCTID": "NCT01019902" - }, - { - "brief_title": "Immunopathology of Autoimmune Hemolytic Anemia", - "phase": "", - "drugs": "['blood samples']", - "drugs_list": [ - "blood samples" - ], - "diseases": "['Autoimmune Hemolytic Anemia']", - "diseases_list": [ - "Autoimmune Hemolytic Anemia" - ], - "enrollment": "27.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients diagnosed with primary warm Autoimmune Hemolytic Anemia (wAIHA) \n\n Secondary AHAI (infections, hematological diseases, systemic diseases) \n\n Naive of treatment for hemolytic anemia or in relapse \n\n Older than 16 \n\n Able to understand written and spoken French \n\n who have provided written informed consent \n\n inclusion criteria for CONTROLS \n\n Persons without auto-immune disease, cancer or active infection. \n\n Older than 16 \n\n Able to understand written and spoken French \n\n who have provided written informed consent \n\n ", - "exclusion_criteria": ": \n\n Cold agglutinin disease \n\n Pregnancy \n\n Persons without national health insurance \n\n ", - "brief_summary": "Autoimmune hemolytic anemia (AIHA) is an auto-immune disease mediated by specific antibodies targeting red blood cells. Its pathogenesis is not completely understood, and the role of T cells have been rarely studied.~The aim of this study is to compare the frequency of circulating T cells, T cell polarization and functions, notably regulatory T cells, during warm AIHA by comparison to healthy controls.~The role of treatments, such as steroids, will also be determined in patients with warm AIHA.", - "NCTID": "NCT02158195" - }, - { - "brief_title": "Chloroquine and Post Malaria Anaemia Study", - "phase": "", - "drugs": "['Chloroquine', 'Placebo']", - "drugs_list": [ - "Chloroquine", - "Placebo" - ], - "diseases": "['Malaria Anaemia']", - "diseases_list": [ - "Malaria Anaemia" - ], - "enrollment": "96.0", - "inclusion_criteria": "inclusion criteria: \n\n All children aged 12 months to 6 years in the 13 study villages will be enrolled in the study and followed up for the duration of the study. The inclusion criteria for randomization will be: \n\n Children aged 12 months to 6 years; and \n\n History of fever in the preceding 48 hours or a measured temperature > 37.5oC plus asexual forms of P. falciparum in the peripheral blood film of 500/\u03bcl or above; and \n\n Hb <110g/l and >69g/l (Our choice of the upper limit of moderate anaemia (70 - 79g/l) is to enable us assess the response to our interventions of severer forms of anaemia while at the same time reducing the risk of adverse events which might occur with lower levels of Hb). \n\n ", - "exclusion_criteria": ": \n\n Refusal of parent or guardian to give consent to the child's participation in the study \n\n Inability of the subjects to take oral medications \n\n Presence of features of severe malaria as defined by WHO50, with the exception of anaemia and parasite density \n\n Children who have urgent need for blood transfusion as indicated by the presence of tachypnoea, tachycardia & gallop rhythm, tender hepatomegaly \n\n Children with known haemoglobinopathy \n\n Children with a weight for height Z score below -3SD of WHO/NCHS standard \n\n Enrolment in another research project", - "brief_summary": "The pathogenesis of post-malaria anaemia is multifactorial. Iron supplementation remains the mainstay of management of moderate and severe anaemia; however the management of mild anaemia (Hb 80-110g/l) is problematic as population supplementation studies of children in malaria endemic areas demonstrate adverse effects in children with mild anaemia. We hypothesize that the anti-inflammatory, anti-malarial and anti-macrophageal iron loading effects of chloroquine could make it a useful drug in the management of mild post malaria anaemia. To test this hypothesis, we plan to randomize children (aged 12 months to 6 years) with post malaria anaemia (Hb 70-110g/l) to receive a standard anti-malarial treatment, co-artemether . All children with parasitologic cure after three days on treatment will be randomised to receive either weekly chloroquine or weekly placebo starting from day 10 till day 90. By comparing the curve of haemoglobin change between day 3 and day 30 in the placebo arms of the two groups, we will test the effect of chloroquine vs. ACT treatment on macrophageal iron loading and release in acute clinical malaria. By comparing the haemoglobin change between day 3 and day 90 between the weekly chloroquine arms and the weekly placebo arms we will test the longer-term anti-inflammatory and anti- malarial effects of weekly chloroquine prophylaxis. In addition to the primary endpoint, we plan to assess potential mechanisms of action by determining parasite clearance, peripheral cytokine production and iron flux", - "NCTID": "NCT00473837" - }, - { - "brief_title": "Study to Evaluate Darbepoetin Alfa in Pediatric Subjects With Anemia Due to Chronic Kidney Disease", - "phase": "Phase 1", - "drugs": "['Darbepoetin alfa']", - "drugs_list": [ - "Darbepoetin alfa" - ], - "diseases": "['Anemia', 'Chronic Kidney Disease']", - "diseases_list": [ - "Anemia", - "Chronic Kidney Disease" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Girls and boys between birth and < 1 year of age at the time of enrollment \n\n Body weight \u2265 3 kg at screening and enrollment \n\n Diagnosis of chronic kidney disease stage 3 to 5 with an estimated Glomerular Filtration Rate < 60 mL/min/1.73m2 without dialysis using the updated Schwartz Equation at screening; OR on dialysis at screening \n\n Hemoglobin \u2264 9.0 g/dL within 7 days prior to enrollment \n\n Transferrin saturation \u2265 20% at screening \n\n ", - "exclusion_criteria": ": \n\n Premature girls and boys (< 37 weeks of gestation, counting from the first day of the mother's last menstrual period) \n\n Peritoneal dialysis subjects with an episode of peritonitis within 30 days prior to enrollment \n\n History of cardiovascular events or thromboembolism \n\n History of upper or lower gastrointestinal bleeding \n\n History of seizures \n\n Active liver disease or history of liver disease \n\n Uncontrolled hypertension defined as stage 2 hypertension or greater. This is defined as a systolic or diastolic blood pressure value greater than the 99th percentile + 5 mmHg for a subject's age \n\n Major surgery 12 weeks prior to enrollment \n\n Red blood cell transfusions 12 weeks prior to enrollment \n\n Use of any erythropoiesis-stimulating agent within 12 weeks prior to enrollment \n\n Currently receiving antibiotic therapy for systemic infection within 4 weeks prior to enrollment \n\n Current or prior use of immunosuppressants (excluding low-dose corticosteroids, defined as \u2264 0.5 mg/kg per day prednisone or equivalent for \u2264 5 days) \n\n Subject is receiving a dose higher than 0.5 mg/kg per day of prednisone (or equivalent dose of another corticosteroid) for > 5 days within 4 weeks prior to enrollment \n\n Receiving or has received any investigational drug (or is currently using an investigational device) within the 30 days or 5 half-lives (whichever is longer) prior to enrollment \n\n Subject has known hypersensitivity to darbepoetin alfa, r-HuEPO, or to any of the excipients", - "brief_summary": "The purpose of this study is to find out more about darbepoetin alfa in children less than 1 year of age with anemia (a decrease in red blood cells) due to kidney failure. This study will see if darbepoetin alfa is safe and well tolerated and whether it causes any side effects by taking blood samples and checking vital signs (heart rate, body temperature, and blood pressure tests) at specific times throughout the study. In addition, the study will evaluate the amount of darbepoetin alfa in the blood over time and look at special markers in the blood to evaluate how darbepoetin alfa works on anemia.~Darbepoetin alfa is approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) for use in adults, but not for all ages of pediatric subjects. Therefore, studies need to be conducted in pediatric subjects (children) to determine the appropriate dose to use in younger children.", - "NCTID": "NCT01428154" - }, - { - "brief_title": "Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment", - "phase": "Phase 1; Phase 2", - "drugs": "['Interleukine-2']", - "drugs_list": [ - "Interleukine-2" - ], - "diseases": "['Autoimmune Hemolytic Anemia']", - "diseases_list": [ - "Autoimmune Hemolytic Anemia" - ], - "enrollment": "2.0", - "inclusion_criteria": "inclusion criteria: \n\n Adults (18 years old) \n\n wAHAI defined by the presence of hemolysis and positive coombs test (IgG +/-C3) \n\n Absence of infection or other hematologic disease \n\n wAHAI not responding to conventional steroids despite a dose over 10 mg \n\n No treatment with rituximab for a minimum of 6 months \n\n Signed informed consent form \n\n ", - "exclusion_criteria": ": \n\n Less than 18 years old \n\n Cold AHAI \n\n IL2 allergy \n\n Chemiotherapy or immunosuppressive treatment \n\n Treatment with rituximab for less than 6 months \n\n Neoplasia or hematologic malignancy \n\n Aplastic anemia \n\n Neutropenia \u2264 1000 mm3 \n\n Infection \n\n Hepatitis B or C \n\n wAHAI associated with systemic lupus erythematosus depending on ACR criteria \n\n Cardiac insufficiency \n\n Hypertension \n\n Pulmonary insufficiency \n\n Liver cirrhosis \n\n Thrombopenia below 50000/mm3 \n\n Drug addiction, alcohol abuse \n\n Psychiatric disorder \n\n Absence of signed informed consent", - "brief_summary": "The investigators have demonstrated that the mean percentage of circulating CD8+ regulatory T (CD8 Tregs) cells is significantly higher in patients with warm hemolytic anemia (wAHAI) in remission than in controls and is correlated to hemoglobin levels. In vitro, low dose of interleukine-2 (IL2) induce the expansion of CD8 Tregs. The objective is to demonstrate that, over a 9 week treatment period; low doses of IL2 can induce the expansion of CD8Tregs in patients with active wAHAI.", - "NCTID": "NCT02389231" - }, - { - "brief_title": "Rituximab in Auto-Immune Hemolytic Anemia", - "phase": "Phase 3", - "drugs": "['rituximab (Mabthera\u00ae)', 'Placebo']", - "drugs_list": [ - "rituximab (Mabthera\u00ae)", - "Placebo" - ], - "diseases": "['Warm Autoimmune Hemolytic Anemia']", - "diseases_list": [ - "Warm Autoimmune Hemolytic Anemia" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n Age > 18 years \n\n AIHA defined at time of diagnosis by a Hgb level \u00a3 10 g/dL, with a reticulocytes count > 120 109/L, signs of hemolysis (at least a haptoglobin level < 4 mg/L), and a positive direct antiglobulin test (DAT) ( IgG or IgG + complement pattern). \n\n Disease duration equal or less than 6 weeks at time of inclusion --> removed by amendment n\u00b04 and substituted by :First episode of AIHA to hot antibody previously untreated or treated corticosteroids for less than 6 weeks. \n\n Patients with an associated autoimmune thrombocytopenia (Evans' syndrome) will be eligible for the study if the platelet count is over 30 x 109/L at inclusion. \n\n Normal level gammaglobulins in the serum (i.e. >5g/L) at inclusion. \n\n Absence of detectable lymph nodes on a total body CT-scan (to be performed before inclusion if not performed at diagnosis). \n\n Effective means of contraception during treatment and for six months after completion of treatment for all women of child bearing age \n\n Negative serum pregnancy test within 14 days prior to study entry. \n\n Written informed consent \n\n ", - "exclusion_criteria": ": \n\n Previous treatment with rituximab \n\n AIHA diagnosed and treated more than 6 weeks prior to inclusion removed by amendment n\u00b04 and substituted by AIHA relapsed or newly diagnosed but treated with corticosteroids for more than 6 weeks \n\n Ongoing immunosuppressive therapy (other than corticosteroids) or previous treatment administered within 2 weeks prior to the beginning of the study treatment \n\n Non-Hodgkin Lymphoma (NHL) other than stage A chronic lymphoid leukemia \n\n Previous or concomitant malignancy other than basal cell or squamous cell carcinoma of the skin, carcinoma-in-situ of the cervix, or other malignancy for which the patient had not been disease-free for at least 5 years. \n\n Autoimmune disorder such as SLE with at least one extra-hematological manifestation requiring a treatment with steroids and/or immunosuppressive drugs. \n\n Any other associated cause congenital or acquired hemolytic anemia (except thalassemia trait or heterozygous sickle cell anemia). \n\n Negative DAT or DAT positive with isolated anti-C3d pattern related to the presence of a monoclonal IgM with cold agglutinin properties. \n\n Positive HIV test and/or hepatitis virus C infection and/or positive hepatitis B virus surface antigen (HbsAg). \n\n Neutrophils count < 1,000/mm 3 at inclusion. \n\n Impaired renal function as indicated by a serum creatinine level > 2 mg/d \n\n Inadequate liver function as indicated by a total bilirubin level > 2.0 mg/dL and/or an AST or ALT level > 2x upper limit of normal. \n\n New York Heart Classification III or IV heart disease. \n\n Previous history of severe psychiatric disorder or are unable to comply with study and follow-up procedures \n\n Pregnant or lactating women, or woman planning to become pregnant within 12 months of receiving study drug \n\n Absence of written informed consent.", - "brief_summary": "The hypothesis based on retrospective data is that, the rate of overall response-rate (PR + CR) at 1 year will be much higher in the rituximab arm (80%) than in the placebo arm (20%).Thirty four patients (17 in each arm) will be include (amendment n\u00b06 - 15/10/2013) over a 3 year period (amendment n\u00b03 - 11/12/2012).", - "NCTID": "NCT01181154" - }, - { - "brief_title": "Long Term Effects of Erythrocyte Lysis", - "phase": "", - "drugs": "['Clinical Evaluations', 'Laboratory Studies']", - "drugs_list": [ - "Clinical Evaluations", - "Laboratory Studies" - ], - "diseases": "['Sickle Cell Disease', 'Hemolytic Anemia']", - "diseases_list": [ - "Sickle Cell Disease", - "Hemolytic Anemia" - ], - "enrollment": "390.0", - "inclusion_criteria": "inclusion criteria: \n\n Established Diagnosis of Hemolysis \n\n Sickle Cell Disease (e.g., HbSS, HbS/\u03b2-thalassemia, HbSC) \n\n Other conditions with hemolysis (e.g., RBC membranopathies, enzymopathies, unstable hemoglobinopathies, PNH) \n\n Age \n\n SCD participants: 5 years of age up to 19th birthday \n\n All other participants: 5 years of age and up (no age limit) \n\n ", - "exclusion_criteria": ": \n\n Previous cardiac surgery \n\n Known left ventricle dysfunction (i.e. shortening fraction < 28%) \n\n Known right sided congenital heart defect such as atrial septal defect or pulmonary valve stenosis", - "brief_summary": "In this prospective observational trial, participants with chronic hemolysis will be assessed with echocardiogram for elevated tricuspid jet velocity and other evidence of pulmonary hypertension. Participants will have laboratory studies evaluating: severity of hemolysis, splenic function, inflammation, endothelial dysfunction, and hypercoagulability. There will be 3 main categories of participants enrolled in this study: (1) pediatric participants with severe sickle cell disease (SCD) (HbSS, HbS/\u03b2\u00b0 thalassemia ) who are not receiving treatment (e.g., hydroxyurea or chronic transfusions); (2) pediatric participants with other forms of SCD or severe SCD (HbSS, HbS/\u03b2\u00b0 thalassemia) patients being treated with hydroxyurea or chronic transfusions; and (3) pediatric and adult participants with other non-sickling hematological disorders.", - "NCTID": "NCT00842621" - }, - { - "brief_title": "Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention in Children With Sickle Cell Anemia", - "phase": "Phase 3", - "drugs": "['sulfadoxine pyrimethamine']", - "drugs_list": [ - "sulfadoxine pyrimethamine" - ], - "diseases": "['Sickle Cell Anemia', 'Malaria']", - "diseases_list": [ - "Sickle Cell Anemia", - "Malaria" - ], - "enrollment": "220.0", - "inclusion_criteria": "inclusion criteria: \n\n Children aged 6 months to 12 years attending sickle cell clinic in Mulago Hospital during the study period with a negative peripheral smear for parasites, adherence to appointment visits, consent by care takers to participate in the study. \n\n ", - "exclusion_criteria": ": \n\n Patients with known allergy to sulfonamides, Patients with severe illnesses requiring urgent admission, Patients with documented treatment for malaria in the past one month with Sulfadoxine- Pyrimethamine. Patients on cotrimoxazole prophylaxis", - "brief_summary": "Malaria is fatal and increases the risk of death among children with sickle cell anemia. Chemoprophylaxis significantly improves quality of life in these children. In Uganda Chloroquine is the drug of choice for prophylaxis and yet it's effectiveness is limited due to high levels of resistance throughout the country. Intermittent presumptive treatment with sulfadoxine - Pyrimethamine a new approach to malaria prevention, has shown great potential in reducing incidence of malaria and anaemia among high risk groups such as pregnant women and infants. However no studies have been done in Uganda to determine if presumptive treatment with sulfadoxine- pyrimethamine reduces the incidence of malaria in children with sickle cell anaemia.~Hypothesis : Presumptive treatment with sulfadoxine- Pyrimethamine is better than weekly chloroquine in reducing incidence of malaria in children with sickle cell anaemia.", - "NCTID": "NCT00399074" - }, - { - "brief_title": "Phase 2 Study of Montelukast for the Treatment of Sickle Cell Anemia", - "phase": "Phase 2", - "drugs": "['Montelukast added to Hydroxyurea', 'Placebo added to Hydroxyurea']", - "drugs_list": [ - "Montelukast added to Hydroxyurea", - "Placebo added to Hydroxyurea" - ], - "diseases": "['Sickle Cell Anemia (HbSS, or HbS\u03b2-thalassemia0)']", - "diseases_list": [ - "Sickle Cell Anemia (HbSS", - "or HbS\u03b2-thalassemia0)" - ], - "enrollment": "46.0", - "inclusion_criteria": "inclusion criteria: \n\n 1)Diagnosis of HbSS, or HbS\u03b2-thalassemia0, confirmed by hemoglobin analysis \n\n 2)Males and females age 16 years to 70 years old \n\n 3)Greater than 2 episodes of pain in the last 12 months \n\n 4)On a stable dose of hydroxyurea for at least 2 months and a stable hemoglobin \n\n ", - "exclusion_criteria": ": \n\n Judged not likely to be study compliant by his/her hematologist \n\n History of adverse reaction to montelukast or any of the components of montelukast \n\n Have used medications known to interact with montelukast such as rifampin, phenobarbital, and gemfibrozil within 4 weeks of enrollment \n\n Currently being treated with a leukotriene antagonist (montelukast or zileuton) or have used montelukast/zileuton within the last 60 days \n\n Chronic blood transfusion therapy defined as regularly scheduled transfusions. \n\n Hemoglobin A greater than15% on hemoglobin analysis \n\n Individuals with a current physician diagnosis of asthma (within last 12 months) or requires continuous supplemental oxygen, or predicted or current use of asthma medications (inhaled corticosteroids, but participants taking bronchodilators will be allowed to participate). \n\n Current participation in another therapeutic trial for SCD \n\n Known current pregnancy \n\n Known history of HIV \n\n Serum creatinine greater than 3 times the site's upper limit of normal", - "brief_summary": "In this feasibility trial, the investigators will compare participants treated with montelukast and hydroxyurea to those treated with placebo and hydroxyurea for a total of 8 weeks.", - "NCTID": "NCT01960413" - }, - { - "brief_title": "Zambia Micronutrient Powder Trial Effectiveness Study", - "phase": "", - "drugs": "['Micronutrient Powders']", - "drugs_list": [ - "Micronutrient Powders" - ], - "diseases": "['Iron Deficiency Anaemia', 'Stunting']", - "diseases_list": [ - "Iron Deficiency Anaemia", - "Stunting" - ], - "enrollment": "631.0", - "inclusion_criteria": "inclusion criteria: \n\n Aged 6-11 \n\n Residing within the project catchment area, and plan on remaining in the same household for the 12 month study duration \n\n Parent/guardian willingness to give consent for the child's participation in the study \n\n ", - "exclusion_criteria": ": \n\n Weight-for-height Z score <3 SD \n\n Mid-upper arm circumference < 11.5 cm \n\n Presence of bilateral oedema \n\n Severe anaemia (Hb < 7.0 g/dl) \n\n HIV positive", - "brief_summary": "Addressing micronutrient deficiencies in Zambia is recognized as a national priority by the government due to its major contribution to morbidity and mortality among children, especially infants in their formative years. One of the most successful, cost-effective, and recommended strategy to address micronutrient malnutrition is 'in-home fortification' with micronutrient powders (Sprinkles being the most widely recognized) along with nutrition education. While this intervention has proven to be safe, effective, and efficacious in numerous other countries, a specific national protocol must be developed to maximize its effect on reducing anaemia in Zambian children. The proposed research aims to inform such protocol.", - "NCTID": "NCT01878734" - }, - { - "brief_title": "Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia", - "phase": "Phase 3", - "drugs": "['prednisolone + mabthera', 'Prednisolone']", - "drugs_list": [ - "prednisolone + mabthera", - "Prednisolone" - ], - "diseases": "['Anemia, Hemolytic, Autoimmune']", - "diseases_list": [ - "Anemia", - "Hemolytic", - "Autoimmune" - ], - "enrollment": "65.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 18 years or over \n\n Clinical and biochemical signs of haemolytic anaemia \n\n Positive Coombs test with anti-IgG on its own or with anti-CD3d \n\n Adequate contraceptive measures (intrauterine device, contraceptive pill or gestagen deposit) for women of childbearing potential \n\n ", - "exclusion_criteria": ": \n\n Performance status > 2 \n\n Previous treatment with Rituximab \n\n Other immune suppressive or anti neoplastic treatment including prednisolone within 3 months \n\n Auto immune haemolytic anaemia within 6 months \n\n Other serious disease \n\n Pregnant women and nursing mothers. Adequate contraceptive measures must be taken for the duration of the study. \n\n Contraindication for treatment with Rituximab, i.e. patients that develop hypersensitivity/allergy to the contents of the drug or have antibodies against murine proteins. \n\n Active infection which requires antibiotic treatment", - "brief_summary": "The conventional treatment in warm-antibody dependent autoimmune haemolytic anaemia (AIHA) is high-dose glucocorticoid, but in more than half of the patients, haemolytic activity will recur after end of treatment or during the gradual reduction in dose of the drug. As a result, many patients will finally be splenectomized or be treated with long-term glucocorticoids or other immunosuppressive drugs as azathioprine or cyclophosphamide. Recent studies have shown however, that some patients will respond to treatment with the chimeric anti-CD 20 antibody Rituximab and is some cases, the response is permanent. In most of the studies, Rituximab has been used in refractory disease or at least as second line treatment. In this study, patients with AIHA are randomized to receive either high-dose prednisolone with gradual reduction in dose over 2-3 months alone or in combination with Rituximab 375 mg/m2 once a week for 4 weeks. The efficacy of Rituximab will be evaluated by a comparison of the patients in the two treatment arms. The primary treatment goal is a reduction in the number of patients who obtain long-term complete or partial remission. The secondary treatment goal is a reduction in patients who will be splenectomised or receive other immunosuppressive drugs. Finally a comparison of side effects of the treatments will take place.", - "NCTID": "NCT01134432" - }, - { - "brief_title": "High Dose Ribavirin in the Treatment of Chronic Hepatitis C", - "phase": "Phase 2", - "drugs": "['High ribavirin dose', 'Standard ribavirin dose']", - "drugs_list": [ - "High ribavirin dose", - "Standard ribavirin dose" - ], - "diseases": "['Chronic Hepatitis C']", - "diseases_list": [ - "Chronic Hepatitis C" - ], - "enrollment": "32.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female patients aged 18-65 years \n\n Elevated liver enzymes levels \n\n Compensated liver disease \n\n Available liver histology confirming METAVIR F2 fibrosis \n\n Written consent to participation \n\n ", - "exclusion_criteria": " \n\n Age <18, >65 \n\n Prior ribavirin treatment \n\n Intolerance towards ribavirin, PegIFN or erythropoetin \n\n Pregnancy or breast feeding \n\n Relevant cardiovascular or pulmonary disease \n\n Kidney insufficiency (creatinine clearance <50ml/min) \n\n Coinfection with HIV or hepatitis B virus \n\n Hepatic comorbidities (hemochromatosis, Wilson's disease, autoimmune disorders) \n\n Alcohol consumption > 40g/day \n\n Psychiatric disorders \n\n Malignancy (except for basalioma) \n\n Active consumption of illicit drugs \n\n Participation in another trial shorter than 3 months prior to inclusion \n\n Lack of consent", - "brief_summary": "Treatment of patients with chronic hepatitis C infected with genotype 1 hepatitis C virus (HCV) consists of combined peginterferon/ribavirin for 48 weeks. Approximately 50% of patients experience sustained virological response which equals cure. All other patients either do not respond or experience recurrence of HCV virus and chronic hepatitis. Important predictors of successful treatment are sustained dosing of both peginterferon and ribavirin. With regard to the latter, clinical evidence indicates that higher ribavirin doses may in fact even improve treatment outcome. However, high ribavirin doses cause hemolytic anemia which require dose reductions. Recent clinical experience show that erythropoetic growth factors, including erythropoetin, can counteract hemolytic anemia caused by antiviral treatment in chronic hepatitis C patients. Therefore, the current trial aims to test whether higher ribavirin doses adapted to a target plasma concentrations instead of a weight-based dosing result in better healing rates, and whether ribavirin-associated hemolytic anemia can be compensated by concommitant erythropoetin treatment.~Using a randomized, controlled, open-label design, the investigators hypothesize that patients with high ribavirin doses adapted to plasma levels experience better viral clearance than patients treated with standard weight-based ribavirin doses. In addition, the investigators hypothesize that erythropoetin treatment will counteract hemolytic anemia induced by ribavirin thereby allowing maintenance of target plasma concentrations without ribavirin dose reductions.", - "NCTID": "NCT00944684" - }, - { - "brief_title": "A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia", - "phase": "Phase 2", - "drugs": "['prednisone, low dose rituximab']", - "drugs_list": [ - "prednisone", - "low dose rituximab" - ], - "diseases": "['Autoimmune Hemolytic Disease (Cold Type) (Warm Type)']", - "diseases_list": [ - "Autoimmune Hemolytic Disease (Cold Type) (Warm Type)" - ], - "enrollment": "23.0", - "inclusion_criteria": "inclusion criteria: \n\n Newly diagnosed warm or cold AIHA, defined by symptomatic anemia and positive DAT, in the absence of underlying lymphoproliferative, infectious or neoplastic disease (according to the single Center diagnostic criteria). \n\n Idiopathic warm or cold AIHA relapsed after first line treatment with oral prednisone. \n\n Aged >18 years \n\n ECOG performance status grade 0, 1 or 2 \n\n No psychiatric illness that precludes understanding concepts of the trial or signing informed consent \n\n Patients who have provided written informed consent prior to study participation, with the understanding that the consent may be withdrawn by the patient at any time without prejudice. \n\n ", - "exclusion_criteria": ": \n\n Cell or humoral immunologic deficit (congenital or acquired) \n\n Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent \n\n Active bacterial, viral, or fungal infection requiring systemic therapy HIV or HbsAg positive (with HBV-DNA+) or HCV-Ab positive (with HCV-RNA+) patients \n\n History of malignancies within 3 years prior to study entry \n\n Concomitant immunosuppressive or cytotoxic treatment \n\n Positive pregnancy test. Lactation. \n\n The presence of associated organ-specific autoimmune diseases do not constitute ", - "brief_summary": "The aim of this prospective study was to evaluate the activity, safety and the duration of the response of low dose rituximab associated with standard oral prednisone as first line therapy in newly diagnosed warm autoimmune hemolytic anemia and cold hemagglutinin disease, and as second line therapy in warm autoimmune hemolytic anemia relapsed after standard oral prednisone. Further aim was to correlate the clinical response to biological parameters (cytokine and anti-erythrocyte antibody production in cultures).", - "NCTID": "NCT01345708" - }, - { - "brief_title": "Patients With High-risk Acute Coronary Syndrome Without ST-segment Elevation", - "phase": "Phase 3", - "drugs": "['Enoxaparin']", - "drugs_list": [ - "Enoxaparin" - ], - "diseases": "['Non ST Segment Elevation Myocardial Infarction', 'Unstable Angina']", - "diseases_list": [ - "Non ST Segment Elevation Myocardial Infarction", - "Unstable Angina" - ], - "enrollment": "62.0", - "inclusion_criteria": "inclusion criteria: \n\n ICF signature; \n\n The research subject must agree about following all instructions and perform the procedures and study visits; \n\n Men and women over the age of 18 and below the age of 75; \n\n History of angina of rest with a minimum duration of 20 minutes in the last 24 hours at the beginning and at least for 10 days. \n\n Patient Randomization up to 6 hours after the arrival at the emergency sector. \n\n Evidence of NSTEMI or unstable angina due to one or more of the following criteria: \n\n 1. Dynamic alterations on the T-wave (ST-segment depression or elevation > 1 mm, and/or T-wave inversions which are solved at least partially when the symptoms are relieved) or 2. Unevenly ST-segment (depression or elevation) in a transitional way under continuous derivations (V1+V2 or V3+V4 or V5+V6 or D1+AVL or D2+D3+AVF) or 3. Biochemical alteration on the myocardial necrosis markers (CKMB mass, troponin T or I and CPK), with the appearance of enzymatic curve, characterizing myocardial injury or 5. Pulmonary Edema; or 6. Angina associated to murmur of mitral regurgitation; or 7. Angina with heart sound to cardiac auscultation or throes; or 8. Angina with hypotension; \n\n ", - "exclusion_criteria": ": \n\n 12-derivation-ECG with persistent ST-segment elevation; \n\n Diagnosis of angina by secondary cause (e.g., anemia, fever, hypovolemia, dehydration, use of cocaine); \n\n Use of non-fractionated heparin or low-molecular weight heparin in the prior 48 to the randomization; \n\n Concomitant diseases, such as severe renal failure (creatinine clearance lower than 30ml/min.) and hepatic, or other significant comorbidities under investigator judgment; \n\n Recent hemorrhagic cerebrovascular accident (last 12 months); \n\n Patient scheduled for cardiac surgery of myocardial revascularization; \n\n Use of drugs, alcohol abuse; \n\n Pregnancy or lactation; \n\n Recent neurosurgery or ophthalmic surgery (last 3 months); \n\n History or diagnosis of coagulopathy; \n\n Medical record containing allergy, hypersensibility or intolerance to any of the drug components to be used on this study, which is judged as clinically significant in the main investigator's opinion; \n\n Recent participation (last 12 months) in a clinical study.", - "brief_summary": "This non-inferiority study aims at comparing Versa\u00ae to the reference enoxaparin (Clexane\u00ae, Sanofi-Aventis) in patients with high-risk unstable angina and NSTEMI. The main justification is the search for scientific evidence to prove the Versa\u00ae effectiveness for this new therapeutic indication, since it is a product with potential for reducing costs, with effectiveness and safety comparable to the reference drug.", - "NCTID": "NCT01356992" - }, - { - "brief_title": "Hematopoietic Stem Cell Transplant for Sickle Cell Disease", - "phase": "Phase 1; Phase 2", - "drugs": "['Fludarabine', 'Hematopoietic Stem Cell Transplant (HSCT)']", - "drugs_list": [ - "Fludarabine", - "Hematopoietic Stem Cell Transplant (HSCT)" - ], - "diseases": "['Sickle Cell Disease', 'Sickle Cell Anemia', 'SCD']", - "diseases_list": [ - "Sickle Cell Disease", - "Sickle Cell Anemia", - "SCD" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients must have one of the following inherited hemoglobin gene disorders: \n\n a. Hemoglobin SS \n\n b. Hemoglobin SC \n\n c. Hemoglobin S-Beta-zero-Thalassemia or \n\n d. Hemoglobin S-Beta-plus Thalassemia with an episode of multi-organ failure within 5 years of eligibility \n\n Patients must meet one of the following risk criteria: \n\n Low Risk (Red Light. Stop and consider therapy closely): Must have matched sibling donor grafts, failed conventional therapy as determined by the PI, and evidence for morbid disease (one of the following): \n\n a. 2 or more painful episode/year (requiring Emergency Department or inpatient care) x 2 years or \n\n b. 1 or more diagnoses of Acute Chest Syndrome within 5 years, or \n\n c. 2-year mortality 5-10% or \n\n d. Baseline LDH>600 IU or \n\n e. History of sepsis, with or without a WBC>13.5, or \n\n f. On chronic transfusions \n\n Moderate Risk (Yellow Light. Reasonable to proceed, but with caution): May have alternate donor grafts (haploidentical or matched unrelated donor), if MSD is not available. Must have history of high-level vasculopathy, as defined by at least one of the criteria below: \n\n a. Urine Albumin to Creatinine Ratio of >300mg/g or eGFR 50-90 ml/min x 2 evaluations within 3 months or \n\n b. History of overt clinical stroke, or progressive cerebral vasculopathy radiographically or \n\n c. 1 or more diagnoses of Acute Chest Syndrome, multi-organ failure, or sickle hepatopathy within 7 years, or \n\n d. Excessively morbid disease manifest as VOCs at a rate of 2 or more per year x 2-years or uncontolled retinal disease attributed to SCD. These patients can be considered for moderate-risk alternate donor transplants. The palliative nature of the transplant will be explicit in the consent. \n\n e. 2-year mortality >10-15% \n\n i. Baseline WBC>13.5 and on chronic transfusions or baseline LDH>600 or age >35 years old, \n\n ii. Baseline TRV \u22653 m/s, \n\n iii. Chronic transfusion therapy and age >35 years old or male gender, \n\n iv. Baseline LDH>600 and age >35 years old or history of sepsis \n\n v. History of sepsis and age >35 years old or male gender. \n\n f. History of multi-organ failure \n\n High Risk (Green light, proceed if possible): All donor types are eligible. Must have high risk disease and a >15% risk of 2-year mortality as defined by at least one of the criteria below. \n\n a. Baseline TRV \u22653 m/s and baseline WBC >13.5 or on chronic transfusions or history of sepsis or age >35 years old, \n\n b. Baseline WBC>13.5 and chronic transfusions or baseline LDH>600 or age >35 years old \n\n c. Age >35 years old and chronic transfusions \n\n To determine eligibility as a bone marrow transplant patient: \n\n Available suitable donor \n\n a. 6/6 HLA-matched sibling donor (HLA A, B, and DRB1), bone marrow only \n\n b. 8/8 HLA-matched unrelated donor (HLA A, B, C, DRB1), bone marrow only \n\n c. 4/8, 5/8, 6/8, 7/8 Haploidentical donor, bone marrow only \n\n Patients must have adequate hematologic, hepatic, and renal function as defined below: \n\n Direct bilirubin within 3 X normal institutional limits \n\n ALT (SGPT) < 3 X institutional upper limit of normal \n\n Creatinine clearance >21 mL/min/1.73 m^2 for subjects with creatinine clearance values below 50 mL/min/1.73 m^2, the principal investigator may use discretion for appropriate fludarabine dose adjustment as noted. \n\n Patients must have adequate pulmonary function as defined by Pulmonary function: DLCO r40% (adjusted for hemoglobin) and FEV1r50%. \n\n Contraception/Child Bearing The effects of Fludarabine, cytoxan, ATG, tacrolimus/sirolimus and MTX are cumulatively known to be deleterious to the health of the developing human fetus. For this reason, and because of teratogenic potential, all women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) for the duration of study participation and for 12 months after completing treatment. \n\n Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status \u2264 2 \n\n Subjects must have the ability to understand and the willingness to sign a written informed consent document. \n\n ", - "exclusion_criteria": ": \n\n Red cell alloimmunization to a degree that precludes extended transfusion \n\n Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements \n\n Subjects must not have evidence of impaired liver function due to iron overload, +/- hepatitis. Patients will be evaluated by liver consult if ferritin >1500, history of hepatitis,or ALTis \u22653 X Upper limit of normal (ULN). Recommended evaluations could include liver biopsy if there is evidence for significant hepatic iron deposition or fibrosis/cirrhosis on T2* MRI of the liver. \n\n eGFR <21 ml/min \n\n \u22652.0 liter-per-minute pm home oxygen requirement \n\n An estimated Left Ventricular Ejection Fraction \u226440% (echo or MUGA) \n\n Hepatic cirrhosis (Biopsy Proven) \n\n HIV positive, ineligible because of the increased risk of lethal infections when treated with marrow suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated \n\n Pregnant or breastfeeding women are excluded from this study because the immunomodulatory treatment, preparative regimen, and anti-GVHD therapy contain agents with the potential for teratogenic or abortifacient effects. \n\n Evidence of uncontrolled bacterial, viral, or fungal infections (currently taking medication and progression of clinical symptoms) within 1 month prior to starting the conditioning regimen. Patients with fever or suspected minor infection should await resolution of symptoms before starting the conditioning regimen. \n\n Prior allogeneic marrow or stem cell transplantation.", - "brief_summary": "This is a phase I/II study of patients with sickle cell disease. It aims to find out if people with sickle cell disease can be cured by changing their immune system before they have blood stem cell transplants. Doctors will give patients a new drug (fludarabine) to see if this drug changes patients immune system and reduces the patient's cells (host) from rejecting donor cells (graft) after the patient gets a Hematopoietic (blood) stem cell transplant.", - "NCTID": "NCT02065596" - }, - { - "brief_title": "Building Capacity for Sustainable Livelihoods and Health", - "phase": "", - "drugs": "['Nutrition and agriculture', 'Iron-rich food & business literacy']", - "drugs_list": [ - "Nutrition and agriculture", - "Iron-rich food & business literacy" - ], - "diseases": "['Malnutrition', 'Anemia']", - "diseases_list": [ - "Malnutrition", - "Anemia" - ], - "enrollment": "3390.0", - "inclusion_criteria": "inclusion criteria: \n\n household with infant < 12 mo or adolescent 10-15 y \n\n Living in selected communities of Upper Manya Krobo District (Ghana) \n\n ", - "exclusion_criteria": ": \n\n infant or adolescent has medical condition that limits dietary intakes or growth", - "brief_summary": "Despite recent economic growth in Ghana, the prevalence of childhood malnutrition remains high. Wasting prevalence affected 29% among 6- to 8-months-old infants in 2008. Poor nutrition contributes to about one-third of child mortality, diminishes cognitive development, and is a major determinant of maternal mortality. The specific objectives of the 5-year project are to: (1) enhance human capacity of government, civil, and private institutions through improvement of knowledge and skills of personnel in agriculture, nutrition and health, entrepreneurship, and pedagogy; (2) identify information needs of local institutions that are not presently met and develop a representative and sustainable longitudinal data system to support evidence-based decision-making in programs; (3) increase vulnerable households' access to quality services in agriculture/fisheries, nutrition and health, and finance; (4) implement integrated intervention activities to improve infant and young child and adolescent nutrition outcomes; and (5) examine differential benefits of the interventions for diverse vulnerable populations. The project comprises two major activities: part I - the creation of a longitudinal data system to support evidence-based decision-making in programs, and part II - the implementation of intervention activities to improve nutrition outcomes.~The survey will include demographic, socioeconomic, health, diet, and nutritional status information collected annually from a representative same of 1500 households with infants (0-12 mo) and 1500 households with adolescents (9-12 y). The data will be analyzed and presented rapidly each year to district program and policy leaders to assist them in developing their activity plans for the following year.", - "NCTID": "NCT01985243" - }, - { - "brief_title": "Echocardiography Management for Patients Requiring Care for Non-Cardiac Surgery", - "phase": "Phase 3", - "drugs": "['Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE)']", - "drugs_list": [ - "Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE)" - ], - "diseases": "['Cardiovascular Risk Factors']", - "diseases_list": [ - "Cardiovascular Risk Factors" - ], - "enrollment": "35.0", - "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 65 years \n\n Hypertension (HTN) \n\n Diabetes \n\n Obesity (body mass index [BMI] >35) \n\n Renal insufficiency \n\n Tobacco usage \n\n Hypercholesterolemia \n\n Sleep apnea/heavy snoring at night \n\n Clinical diagnosis of CHF as defined by: \n\n Dyspnea on exertion \n\n Paroxysmal nocturnal dyspnea \n\n Orthopnea \n\n Elevated jugular venous pressure \n\n Pulmonary rales \n\n Third heart sound \n\n Cardiomegaly or pulmonary edema on chest x-ray \n\n Peripheral edema \n\n Hepatomegaly \n\n Pleural effusion \n\n Palpitations/irregular heart beats \n\n Chest pain at rest and or exercise \n\n Murmur on examination \n\n Known coronary artery disease (CAD)/stents/coronary artery bypass graft (CABG) \n\n Known valvular disease \n\n Known stroke or transient ischemic attacks (TIA) \n\n ", - "exclusion_criteria": ": \n\n Patients expected to say in the hospital for less than 24 hours. \n\n Inability of undergo TEE and TTE \n\n Clinical evidence or suspicion of elevated intracranial pressure. \n\n Preoperative shock or systemic sepsis \n\n Emergency Operation \n\n ASA Class V \n\n Inability of give informed consent \n\n Participation in another clinical trial \n\n Prisoner", - "brief_summary": "The growing population of University of Nebraska Medical Center patients with heart failure combined with the increasing number of surgical procedures performed each year supports the need for a critical analysis of how to most appropriately manage these patients during the perioperative period, especially for non-cardiac surgery. Echo-guided hemodynamic management (EGHEM) is the use of echocardiography data to normalize and/or optimize in real-time, cardiac output and ventricular filling pressures in the perioperative period for non-cardiac surgical cases. The purpose of this study is to test the hypothesis that EGHEM compared to standard management practices will result in a reduced length of hospital stay in the noncardiac surgery population. The primary goal of health care providers for patients requiring anesthetic care, perioperative care, or critical care is ensuring the adequacy of the patient's circulatory function by optimizing cardiac output and ventricular filling pressure. Currently, the use of the ECG monitor and systemic blood pressure are the standard of care for assessing circulatory function. However, those data cannot provide accurate information on cardiac output and ventricular filling pressure for patients with cardiovascular risk factors and/or comorbidities. As a result, managing the hemodynamic parameters of these patients, as well as their intravenous fluid needs and resuscitation strategy, we hypothesize that using traditional approaches may lead to significant volume overload and post-operative cardiovascular complications and morbidity. In this study we propose an EGHEM strategy that incorporates standard echocardiography generated data points in addition to the systemic blood pressure and ECG signal to assess, manage, modify and optimize patient cardiac preload, afterload, heart rate and contractility in the perioperative period. Based on our initial observations and preliminary data using the EGHEM approach, we hypothesize that we can demonstrate a significant decrease in hospital length of stay and an overall decrease in perioperative morbidity at 30 days in the non-cardiac surgery population using EGHEM compared to standard practices. In this proposal we have designed a single center, prospective, randomized clinical trial to test our hypothesis.", - "NCTID": "NCT01050361" - }, - { - "brief_title": "Efficacy of Artesunate-amodiaquine (AS-AQ) in Children With Malaria and Severe Acute Malnutrition, Madaoua, Niger 2010", - "phase": "Phase 4", - "drugs": "['Artesunate-amodiaquine fixed-dose combination']", - "drugs_list": [ - "Artesunate-amodiaquine fixed-dose combination" - ], - "diseases": "['Malaria, Falciparum', 'Malnutrition', 'Child']", - "diseases_list": [ - "Malaria", - "Falciparum", - "Malnutrition", - "Child" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Age between 6 and 59 months \n\n Weight \u22655kg \n\n P. falciparum monoinfection confirmed on a thick blood film \n\n Parasitic density between 1,000 and 200,000 asexual forms/uL of blood \n\n Measured axillary temperature \u226537.5\u00b0C or history of fever during the previous 24 hours \n\n Severe malnutrition (defined as a weight/height ratio less than -3 z-scores) \n\n High probability of compliance with follow-up visits (home is within two hours of walk from the outpatient department, no near-term travel plans, etc..) \n\n Consent of a parent or guardian who is at least 18 years of age. \n\n ", - "exclusion_criteria": ": \n\n Signs of a critical illness as defined by the WHO (WHO (2000) Severe falciparum malaria; Clinical features of severe falciparum malaria in children. Royal Society of Tropical Medicine and Hygiene, 94 (supplement 1), 5-11). \n\n Signs of severe or complicated malaria as defined by the WHO (WHO (2000) Severe falciparum malaria; Clinical features of severe falciparum malaria in children. Royal Society of Tropical Medicine and Hygiene, 94 (supplement 1), 5-11). \n\n Severe anaemia (haemoglobin <5 g/dL) \n\n Known history of hypersensitivity to any of the study medications, \n\n Symmetric oedema in the feet, \n\n Concomitant febrile illness not originating from malaria, which could alter the outcome of the study (measles, acute lower respiratory tract infection, otitis media, tonsillitis, abscesses, severe diarrhea with dehydration, etc.), \n\n History of a full treatment course with the study drug in the past 28 days.", - "brief_summary": "The purpose of the study is to determine whether the artesunate-amodiaquine combination is effective in treating uncomplicated Plasmodium falciparum malaria in children with severe acute malnutrition.~Infection with Plasmodium falciparum malaria remains a significant cause of morbidity and mortality in malnourished children. Malnutrition is known to have a modulating effect on the incidence of malaria infections, its severity and effectiveness of treatments. However, little data exists on antimalarial drug efficacy in malnourished children. Artesunate-amodiaquine combination is the first line treatment used in M\u00e9decins Sans Fronti\u00e8res programmes in Niger. The assumption of current efficacy of artesunate-amodiaquine is based on non malnourished children. The aim of this study is to measure the clinical and parasitological efficacy in severely malnourished children.~The study is consistent with the standard WHO protocol for monitoring antimalarial drug efficacy (WHO: Methods for surveillance of antimalarial drug efficacy. Geneva; 2009), except for one inclusion criterion. Severe acute malnutrition is an inclusion criteria, instead of being an exclusion criteria. The study will encompass a pharmacokinetic part that will provide important information on the absorption of the drug.", - "NCTID": "NCT01204411" - }, - { - "brief_title": "Automated Algorithm Based Analysis of Phonocardiograms of Newborns", - "phase": "", - "drugs": "['Computer aided auscultation (CAA)']", - "drugs_list": [ - "Computer aided auscultation (CAA)" - ], - "diseases": "['Heart Murmurs', 'Mitral Valve Prolapse', 'Systolic Murmurs']", - "diseases_list": [ - "Heart Murmurs", - "Mitral Valve Prolapse", - "Systolic Murmurs" - ], - "enrollment": "220.0", - "inclusion_criteria": "inclusion criteria: \n\n any premature baby or newborn \n\n parental approval for study participation \n\n ", - "exclusion_criteria": ": \n\n none", - "brief_summary": "The purpose of this double-blind pivotal clinical utility study is to determine on a large patient population whether heart murmurs can be reliably detected with high sensitivity and specificity using a locked, automated algorithm-based phonocardiogram analysis (also referred to as computer aided auscultation (CAA)).~Each patient is auscultated and diagnosed independently by a medical specialist. Additionally, for each patient, an echocardiogram is performed as the gold-standard for determining heart pathologies. The CAA results are compared to the findings of the medical professionals as well as to the echocardiogram findings.~Hypothesis: The specific (locked) CAA algorithms used in this study are able to automatically diagnose pathological heart murmurs in premature babies and newborns with at least the same accuracy as experienced medical specialists.", - "NCTID": "NCT02105480" - }, - { - "brief_title": "Comparison of Digital Electronic Stethoscope to Computed Tomography (CT) Angiography in Detection of Coronary Artery Disease", - "phase": "", - "drugs": "['CardioSond Cardiac Sonospectrographic Analyzer']", - "drugs_list": [ - "CardioSond Cardiac Sonospectrographic Analyzer" - ], - "diseases": "['Coronary Artery Disease']", - "diseases_list": [ - "Coronary Artery Disease" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects who are undergoing routine screening coronary CT angiography \n\n Willingness to sign informed consent form \n\n ", - "exclusion_criteria": ": \n\n Inability to provide informed consent form \n\n Age less than 21 years \n\n Any contraindications to coronary CT angiography \n\n Known atherosclerotic heart disease, including a history of prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery or an established diagnosis of CAD by prior X-ray or CT angiography \n\n Supraventricular or ventricular arrhythmias that would be expected to affect CT-angiography image quality (e.g., atrial fibrillation, atrial flutter, ventricular tachycardia, bigeminy, and trigeminy). Patients with isolated premature atrial contractions and premature ventricular contractions may enroll. \n\n Use of intravenous vasodilators \n\n Any pulmonary conditions that would create abnormal physical findings that would interfere with the fidelity of the cardiac sound recording (e.g., obstructive pulmonary disease, such as asthma or COPD, with audible wheezing). \n\n Presence of audible aortic or pulmonic diastolic murmurs, tricuspid or mitral flow diastolic murmurs, or continuous murmurs", - "brief_summary": "The study is designed to evaluate the predictive diagnostic accuracy of SonoMedica's CardioSond digital electronic stethoscope in the detection of coronary artery disease (CAD) in patients without known disease who are referred to cardiac computed tomography angiography (CT scans).", - "NCTID": "NCT01040923" - }, - { - "brief_title": "Effect of Acne Vulgaris on Quality of Life of Teenagers Compared to Parent Perceived Effect on Quality of Life", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Acne', 'Quality of Life']", - "diseases_list": [ - "Acne", - "Quality of Life" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n Between 12 and 17 years of age \n\n diagnosis of acne by a pediatric dermatologist \n\n ability to read and understand English \n\n age appropriate development \n\n ", - "exclusion_criteria": ": \n\n \u2022 developmental delay", - "brief_summary": "Acne vulgaris is a common problem in the adolescent community. Past research has shown that acne affects teenager's self-esteem and mood. However, no research has evaluated the parent perception of their teenager's acne in comparison to the severity of acne and the patient's own reported quality of life. It is hypothesized that parents of teenagers underestimate how much acne vulgaris affects their teenager's skin disease-related quality of life. Also that teenager's perception of the severity of their acne is greater versus their parent's perception. We believe that increased acne severity based on clinician assessment will correlate with worse quality of life. Teenagers between 12 and 17 years old with a diagnosis of acne by a pediatric dermatologist will be enrolled in this study. The study consists of 1 visit, questions regarding demographics, assessment of the teen's acne, the Skindex-Teen quality of life survey (modified for parents), and 2 Likert scales will be completed. In addition, the clinician will score the teen's acne using the standardized Investigator Global Assessment tool. Statistical analysis will compare teen subject answers to the Skindex-Teen with their parent's answers. Also analyzed will be the severity of acne and differences between the clinician IGA score and Skindex-Teen responses", - "NCTID": "NCT01835210" - } - ], - "1": [ - { - "brief_title": "Nutrition Study of Effect of High Iron Beans on Iron Status", - "phase": "", - "drugs": "['Biofortified beans', 'BEAN']", - "drugs_list": [ - "Biofortified beans", - "BEAN" - ], - "diseases": "['Iron Deficiency']", - "diseases_list": [ - "Iron Deficiency" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n Non-pregnant adolescent subjects of reproductive age with low iron stores with or without mild anemia, who are otherwise healthy, will be enrolled in the study \n\n ", - "exclusion_criteria": ": \n\n Pregnant, lactating, severe anemia, low BMI would be excluded", - "brief_summary": "The purpose of this study is to determine whether beans bred to have a high iron content are effective in improving the iron status of young women.", - "NCTID": "NCT01594359" - }, - { - "brief_title": "A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)", - "phase": "Phase 2", - "drugs": "['Fostamatinib 150 mg bid']", - "drugs_list": [ - "Fostamatinib 150 mg bid" - ], - "diseases": "['Warm Antibody Autoimmune Hemolytic Anemia']", - "diseases_list": [ - "Warm Antibody Autoimmune Hemolytic Anemia" - ], - "enrollment": "26.0", - "inclusion_criteria": "inclusion criteria: \n\n Subject must have had a diagnosis of primary or secondary warm antibody AIHA. \n\n - Must have failed at least 1 prior treatment regimen for AIHA. \n\n ", - "exclusion_criteria": ": \n\n Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria. \n\n Subject with a platelet count of < 30,000/\u03bcL. \n\n Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable or is not well-controlled on current therapy. \n\n Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure \u2265 130 mmHg, or diastolic blood pressure \u2265 80 mmHg.", - "brief_summary": "The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).", - "NCTID": "NCT02612558" - }, - { - "brief_title": "A Trial of 2 'Point of Care' Diagnostic Methods to Improve Detection and Treatment of Anaemia in African Children", - "phase": "", - "drugs": "['Hemocue 210 meter', 'Copack HBCS']", - "drugs_list": [ - "Hemocue 210 meter", - "Copack HBCS" - ], - "diseases": "['Anaemia']", - "diseases_list": [ - "Anaemia" - ], - "enrollment": "450.0", - "inclusion_criteria": "inclusion criteria: \n\n Age under 5 years \n\n Pregnancy \n\n Suspected anaemia", - "exclusion_criteria": "", - "brief_summary": "A high proportion of children under the age of 5 years and pregnant women in Tanzania is anaemic, particularly in areas of high malaria transmission. The symptoms of anaemia are often non-specific or absent and clinical judgement is generally insensitive in estimating Hb levels, especially in infants who are assessed by basic grade health staff. Thus while treatment for the common causes of anaemia is available, many cases are not treated due to difficulties in recognising anaemia.~New diagnostic tools can increase the sensitivity of anaemia detection compared to clinical diagnosis but no studies have demonstrated their effectiveness in increasing case-detection and treatment of anaemic patients at the first level of healthcare. In addition, the costs of their use in relation to any increase in numbers of cases treated are not known and this knowledge is needed to guide public health decisions.~Two methods of measuring anaemia are currently suitable for use at the first level of care; Copack Haemoglobin colour scale (HBCS) and Hemocue portable photometry. We propose to compare the effectiveness in basic health facilities of these 2 simple diagnostic tools compared to control dispensaries (current practice) in increasing rates of detection and treatment of anaemia in children under the age of 5 years and pregnant women over the course of 1 year in a cluster-randomised trial in 30 dispensaries in a malaria-endemic area of NE Tanzania.", - "NCTID": "NCT00439595" - }, - { - "brief_title": "The Role of Microparticles as a Biomarker", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Atypical Hemolytic Uremic Syndrome', 'Thrombotic Thrombocytopenic Purpura', 'Microparticles', 'Microangiopathic Hemolytic Anemia']", - "diseases_list": [ - "Atypical Hemolytic Uremic Syndrome", - "Thrombotic Thrombocytopenic Purpura", - "Microparticles", - "Microangiopathic Hemolytic Anemia" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients with MAHA, TTP, and/or aHUS \n\n ", - "exclusion_criteria": ": \n\n Prisoners", - "brief_summary": "The investigators propose to characterize MPs in aHUS and TTP both at the onset and throughout treatment. The investigators believe that the number, size, and cell origin of MPs will differ between these two diseases. The hypothesis is that endothelial derived MPs will be higher in number and comprise a larger portion of the MP population in aHUS and that platelet MPs will comprise a larger number and greater proportion of MPs in TTP. The investigators believe that MP identity and number can be used to reliably differentiate between aHUS and TTP at disease onset.", - "NCTID": "NCT02626663" - }, - { - "brief_title": "Efficacy of Web-based Cognitive Behavioural Treatment for Adolescents With Chronic Fatigue Syndrome", - "phase": "", - "drugs": "['FitNet treatment', 'Usual care']", - "drugs_list": [ - "FitNet treatment", - "Usual care" - ], - "diseases": "['Chronic Fatigue Syndrome']", - "diseases_list": [ - "Chronic Fatigue Syndrome" - ], - "enrollment": "135.0", - "inclusion_criteria": "inclusion criteria: \n\n Adolescents (12 - 18 years) with Chronic Fatigue Syndrome \n\n ", - "exclusion_criteria": ": \n\n Score greater than or equal to 44 on the Stait-Trait Anxiety Inventory for Children \n\n Score greater than or equal to 20 on the Children's Depression Inventory \n\n No availability of computer and/or internet \n\n Risk of suicide \n\n Mental retardation", - "brief_summary": "The aim of this study is to determine the efficacy of FITNET (web-based cognitive behavioural treatment) for adolescents with Chronic Fatigue Syndrome (CFS) in The Netherlands. The second goal of the study is to establish predictors of outcome. It is very important to know the characteristics of patients who will benefit from Cognitive Behavioural Treatment (CBT) and who will not. Possible predictors of outcome are: age, depression, anxiety, fatigue of the mother, parental bonding, self-efficacy, body consciousness of child and mother, physical activity (Actometer).", - "NCTID": "NCT00893438" - }, - { - "brief_title": "Biliary Atresia, Hepatic Buffer Response and Sevoflurane", - "phase": "", - "drugs": "['Sevoflurane']", - "drugs_list": [ - "Sevoflurane" - ], - "diseases": "['Biliary Atresia']", - "diseases_list": [ - "Biliary Atresia" - ], - "enrollment": "25.0", - "inclusion_criteria": "inclusion criteria: \n\n persistent yellow skin or sclera, pale stool (in severe cases, clay-like), and hepatomegaly; \n\n increased serum bilirubin (progressively or no decline after increase), increased total bilirubin (TBil) dominated by increased direct bilirubin (DBil) (>60%); \n\n elevated liver enzymes; \n\n ultrasound confirmation of poor gallbladder filling and signs of liver fibrosis; \n\n with radionuclide imaging confirmation of obstructed biliary excretion \n\n ", - "exclusion_criteria": ": \n\n concomitant cardiovascular or abdominal organ malformations", - "brief_summary": "To evaluate the effects of sevoflurane on hepatic blood flow (HBF) and hepatic arterial buffer response (HABR) in infants with obstructive jaundice by Doppler ultrasound.Twenty-five infants with biliary atresia (1-3 months-of-age) scheduled for a Kasai procedure were enrolled. portal vein blood flow (PBF), hepatic arterial blood flow (HABF) and hepatic blood flow (HBF) were measured by Doppler ultrasound before induction, and after inhalation of 2 and 3% sevoflurane.", - "NCTID": "NCT02471209" - }, - { - "brief_title": "Safety and Efficacy Study of Ibuprofen l-Lysine Solution in Premature Infants for Treatment of PDA", - "phase": "Phase 3", - "drugs": "['ibuprofen l-lysine iv solution (NeoProfen (R) )']", - "drugs_list": [ - "ibuprofen l-lysine iv solution (NeoProfen (R) )" - ], - "diseases": "['Patent Ductus Arteriosus']", - "diseases_list": [ - "Patent Ductus Arteriosus" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Premature newborn infant of either gender with a birth weight of 500 to 1000 grams, appropriate for gestational age; \n\n Non-symptomatic PDA with evidence of ductal shunting documented by an echocardiogram (ECHO); \n\n Less than 72 hours of age at the time of randomization; \n\n If infant is one of a multiple birth, he/she is one of the two (2) oldest infants who meet the eligibility criteria; \n\n Consent form signed by parent. \n\n ", - "exclusion_criteria": ": \n\n Either major congenital malformations and/or chromosomal anomalies; \n\n Proven, severe congenital bacterial infection; \n\n Maternal antenatal nonsteroidal anti-inflammatory drug (NSAID) exposure < 72 hours prior to delivery; \n\n Treatment with pharmacological replacement steroid therapy at anytime since birth; \n\n Unremitting shock requiring very high doses of vasopressors (i.e. inability to maintain mean arterial blood pressure appropriate for gestational age \u00b1 2 SD using volume and maximal vasopressor therapy as defined by the individual institution); \n\n Renal failure or oliguria defined as urine flow rate < 0.5 mL/kg/hr in the 8 hours prior to randomization (Anuria is acceptable if infant is in first 24 hours of life); \n\n Platelet count < 75,000/mm 3; \n\n Clinical bleeding tendency (i.e. oozing from puncture sites); \n\n Expected survival less than 48 hours in the opinion of the attending neonatologist; \n\n Participation in other clinical intervention trials. Exceptions may be made if approved by Medical Director or designee, RPD Pharmaceutical Department; \n\n Symptomatic PDA as documented by 3 of the following 5 criteria \n\n Bounding pulse \n\n Hyperdynamic precordium \n\n Pulmonary edema \n\n Increased cardiac silhouette \n\n Systolic murmur Or, in view of the neonatologist is deemed to have a hemodynamically significant ductus. \n\n Exposure to NSAIDs at any time since birth.", - "brief_summary": "The purpose of this study is to determine the safety and effectiveness of ibuprofen l-lysine iv in premature infants in the early treatment of Patent Ductus Arteriosus.", - "NCTID": "NCT00440804" - } - ], - "2": [ - { - "brief_title": "Automatic Differentiation of Innocent and Pathologic Murmurs in Pediatrics", - "phase": "", - "drugs": "['Computer Aided Auscultation (CAA)']", - "drugs_list": [ - "Computer Aided Auscultation (CAA)" - ], - "diseases": "['Heart Murmurs', 'Mitral Valve Prolapse', 'Systolic Murmurs']", - "diseases_list": [ - "Heart Murmurs", - "Mitral Valve Prolapse", - "Systolic Murmurs" - ], - "enrollment": "106.0", - "inclusion_criteria": "inclusion criteria: \n\n outpatient \n\n parental approval for study participation \n\n ", - "exclusion_criteria": ": \n\n none", - "brief_summary": "The purpose of this preliminary clinical study is to assess the quality of a computational algorithm that automatically classifies murmurs of phonocardiograms (PCGs) as either pathologic (AHA class I) or as no- or innocent (AHA class III) in the pediatric population.~Each patient is auscultated and diagnosed independently by a medical specialist by means of a standard mechanical stethoscope. Additionally, for each patient, a PCG is recorded using a Littmann 3200 electronic stethoscope and later analyzed using the computational algorithm. An echocardiogram is performed as the gold-standard for determining heart pathologies. The results of the computer aided auscultation (CAA) are compared to the findings of the medical professionals as well as to the echocardiogram findings.~Hypothesis: The specific CAA algorithms used in this study are able to differentiate pathologic (AHA class I) from no- or innocent murmurs (AHA class III) in a pediatric population.", - "NCTID": "NCT02512341" - }, - { - "brief_title": "Understanding Pediatric Chest Pain and Other Symptoms", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Chest Pain']", - "diseases_list": [ - "Chest Pain" - ], - "enrollment": "156.0", - "inclusion_criteria": "inclusion criteria: \n\n 8-18 years of age \n\n Pediatric patients with referrals for innocent heart murmurs \n\n Pediatric patients experiencing chest pain \n\n English speaking \n\n ", - "exclusion_criteria": ": \n\n Non English speaking patients", - "brief_summary": "The causes of pediatric pain are often not the same for every child. Most children who visit a cardiology specialist with complaints of chest or other somatic pain have no known medical diagnosis to explain their symptoms. These children and their families often leave with no explanation for the child's distress.~This early study will ask parents and children specific questions related to the stress in their lives, their emotional well-being and the children's physical functioning. The investigators want children who experience chest and other somatic pain, and those who do not, to be in their study so that they can look at both groups.~The investigators hope to use these answers to better inform cardiologists who often work with children with non-cardiac pain and, in turn, help them to better serve their patients. Ultimately, the investigators hope that the answers they get will provide answers to these families. They also hope to use the results of this study to put together a short screener for the cardiologist to give to pediatric patients with complaints of chest or other somatic pain to help the cardiologists better understand their patients' symptoms.", - "NCTID": "NCT00166231" - } - ] - }, - { - "patient_id": "sigir-201528", - "patient": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", - "0": [ - { - "brief_title": "Lyme Disease Prevention Program", - "phase": "Phase 3", - "drugs": "['Education about disease prevention']", - "drugs_list": [ - "Education about disease prevention" - ], - "diseases": "['Lyme Disease', 'Tick-Borne Diseases']", - "diseases_list": [ - "Lyme Disease", - "Tick-Borne Diseases" - ], - "enrollment": "20000.0", - "inclusion_criteria": "inclusion criteria: \n\n Ferry passengers traveling to Nantucket Island \n\n ", - "exclusion_criteria": ": \n\n Foreign (non-U.S.) residence", - "brief_summary": "This is a large study of an educational program on Lyme disease prevention for passengers on ferry boats going to Nantucket Island during the period from Memorial Day until Labor Day. Some boats provide passengers with the experimental program and the other boats provide a control program that the researchers can compare to the experimental program. The experimental program uses live performances by entertainers to teach people about Lyme disease prevention, and also uses additional printed materials. People on the control boats receive education on injury prevention and road safety while bicycling, rollerblading, and using mopeds. The main result we will look for is Lyme disease identified by a followup survey and confirmed by reviewing medical records. We will also ask some people to take part in a smaller study of behavior change. In this study, we will ask people to complete forms on self-efficacy (a person's belief in his or her ability to reach a certain goal), their plans to take preventive steps, and actual prevention behaviors. We also ask participants who report doctor visits or illness to provide confirmation of their use of health services.", - "NCTID": "NCT00000432" - }, - { - "brief_title": "A School-Based Intervention to Reduce Lyme Disease", - "phase": "", - "drugs": "['Education', 'Control (pre and post surveys)']", - "drugs_list": [ - "Education", - "Control (pre and post surveys)" - ], - "diseases": "['Lyme Disease']", - "diseases_list": [ - "Lyme Disease" - ], - "enrollment": "3570.0", - "inclusion_criteria": "Inclusion: \n\n Child age 7-12 and their parents living in the selected endemic areas \n\n Exclusion: \n\n No exclusions", - "exclusion_criteria": "", - "brief_summary": "Our overall purpose of this study is evaluate whether a short in-class Lyme Disease education program based on social learning theory and the Health Belief Model can impact a child's knowledge, attitude, and preventive behavior.~1. Deliver an educational program in schools to promote personal protective practices, encourage early disease detection and modify residential habitats to reduce tick density.~3. Evaluate the program's efficacy by comparing the acceptability and practice of precautionary behavior, tick density in residential areas and rates of Lyme disease between groups using primary and surveillance data sources Evaluate the contribution of knowledge, attitudes, and parental involvement to children's adoption of prevention strategies.~Hypothesis~The community intervention will reduce the incidence of Lyme disease among children and families living in endemic areas by increasing the practice of precautionary behavior and reducing tick density in residential areas. Specifically, we hypothesize that:~The educational intervention will reduce the incidence of Lyme disease among children and families living in an endemic area.~The educational intervention will improve the childrens' self-confidence (behavioral self-efficacy), intention to perform, and actual practice of Lyme disease prevention behaviors.", - "NCTID": "NCT00594997" - }, - { - "brief_title": "A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Lyme Disease']", - "diseases_list": [ - "Lyme Disease" - ], - "enrollment": "700.0", - "inclusion_criteria": "inclusion criteria: \n\n SCREENING FOR SUSPECTED PTLDS \n\n Age >= 13 years old, suspect of suffering from Lyme disease \n\n POST-TREATMENT LYME DISEASE SYNDROME (PTLDS) \n\n For the purposes of this study, PTLDS is defined as (1) occurring in male or female patients aged 13 and above (2) who have been diagnosed with confirmed or probable Lyme disease per CDC definition (https://wwwn.cdc.gov/nndss/conditions/lyme-disease/case-definition/2017/). Study physician will review history to confirm probable cases. (3) They have received recommended antibiotic therapy (4) and have persistent or relapsing symptoms and/or signs for at least six months after therapy [4, 5]. (5) They also should have no other documented explanation for their signs and symptoms. \n\n LYME ARTHRITIS CONTROLS \n\n For the purposes of this study, Lyme arthritis is defined as occurring in an otherwise healthy male or female aged 18 and above who have intermittent episodes of arthritis involving one or few joints, without any other cause being documented, and have positive serum antibodies to B. burgdorferi confirmed by IgG Western blot according to the CDC criteria. \n\n RECOVERED CONTROLS \n\n For the purposes of this study, a recovered control is defined as an otherwise healthy male or female aged 18 and above who has had confirmed or probable Lyme disease, fulfilling the CDC Lyme Disease National Surveillance Case Definition (appendix 5), and who had received accepted antibiotic treatment for Lyme disease [5] (at least 3 months since the end of antibiotic therapy before protocol evaluation) and who are currently asymptomatic. \n\n SEROPOSITIVE CONTROLS \n\n For the purposes of this study, a seropositive control is defined as an otherwise healthy male or female aged 18 and above who has positive serum IgG antibody response to B. burgdorferi by Western blot according to the CDC criteria and are asymptomatic and who recall no episodes of disease compatible with Lyme infection and have not received antibiotic therapy for Lyme \n\n disease. \n\n OSPA VACCINATED CONTROL \n\n For the purposes of this study, an OspA vaccinated control is defined as an otherwise healthy male or female age 18 and above who has received at least two doses of the OspA vaccine for Lyme disease (Lymerix ). These controls may have a positive ELISA for B. burgdorferi but a negative (or unreadable) IgG western blot. \n\n MULTIPLE SCLEROSIS CONTROLS \n\n For the purposes of this study, a multiple sclerosis control is defined as an otherwise healthy male or female aged 18 and above with relapsing-remitting or progressive multiple sclerosis as defined by the Clinical Trial Committee of the National Multiple Sclerosis Society and no evidence of prior exposure to B. burgdorferi as indicate by negative history for Lyme disease and negative western blot for B. burgdorferi in the serum by the CDC criteria. Patients should have a Kurtzke or Expanded Disability Status Scale (EDSS) between 1 and 5. \n\n HEALTHY VOLUNTEERS \n\n For the purpose of this study, a healthy volunteer is defined as healthy male or female, age 18 and above, with no history compatible with Lyme disease and negative serological testing to B. burgdorferi by the CDC criteria. \n\n GENERAL ", - "exclusion_criteria": " \n\n Age less than 18 (less than 13 for patients with PTLDS) \n\n Weight less than 70 Lb. (35 kg) \n\n Pregnancy or lactation \n\n Women with childbearing potential who are sexually active with a male partner and unwilling to use effective contraception during the evaluation and treatment phases of the protocol. \n\n Clinically significant laboratory abnormalities including positive test for syphilis (RPR), HBsAg, anti-HCV, anti-HIV. \n\n Chronic medication use will be evaluated in a case-by-case basis. \n\n Not able to understand all of the requirements of the study or unable to give informed consent and/or comply with all aspects of the evaluation. \n\n All study participants must agree to allow their samples to be used for future research. \n\n ", - "brief_summary": "This study will determine whether patients who have been infected with the Lyme bacteria, Borrelia burgdorferi, and treated with antibiotics still have the bacteria alive inside them and whether it is causing their symptoms. The information from this study may serve as a basis for developing stringent diagnostic criteria for Lyme disease and the establishment of future treatment trials.~Individuals in the following categories may be eligible for this study: chronic Lyme disease; chronic Lyme arthritis; seropositive control (are infected with the bacteria that causes Lyme disease but do not have disease symptoms); recovered control (have been sick with Lyme disease but were treated successfully and are currently well); control with multiple sclerosis (patients with multiple sclerosis); and healthy volunteers. Patients in the chronic Lyme disease category must be age 13 and above; all others must be age18 and above. Candidates will be screened with blood and urine tests.~Participants will have a physical examination and the following tests:~Blood tests Includes HLA-typing, a genetic test of immune system markers;~Leukapheresis Collection of large numbers of white blood cells Whole blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components. The white cells are removed and the rest of the blood is returned to the body, either through the same needle used to draw the blood or through another needle in the other arm. (Alternatively, patients will 100 cc (about 7 tablespoons) of blood drawn.);~Lumbar puncture (spinal tap) Collection of cerebrospinal fluid (CSF, fluid that bathes the brain and spinal cord). A local anesthetic is administered and a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle;~Magnetic resonance imaging (MRI) of the brain Imaging of the brain using a strong magnetic field and radio waves instead of X-rays. During the scan, the patient lies on a table in a narrow cylinder containing a magnetic field. He or she can speak with a staff member via an intercom at all times during the procedure;~Neuropsychologic testing;~Some participants may also have a hearing test and urine collection.~Participants whose test results are positive for Borrelia burgdorferi will be followed at NIH at intervals of 3 to 6 months until it is determined whether there is infection. Those who are infected will be offered treatment with the antibiotic ceftriaxone. Following treatment, patients will return to the NIH Clinical Center for follow-up visits 1 week after treatment and again at 3, 6 and 12 months. The lumbar puncture, hearing examination, blood and urine tests will be repeated at these visits to evaluate the response to treatment, and the leukapheresis will be repeated for research purposes. Patients whose MRI was abnormal during therapy will have a repeat MRI at the 3-month, 6-month and 1-year visits.~All participants with chronic Lyme disease, chronic Lyme arthritis, seropositive controls and recovered controls may be reevaluated at intervals of 6 to 12 months.", - "NCTID": "NCT00001539" - }, - { - "brief_title": "A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seronegative Chronic Lyme Disease", - "phase": "Phase 3", - "drugs": "['ceftriaxone', 'doxycycline']", - "drugs_list": [ - "ceftriaxone", - "doxycycline" - ], - "diseases": "['Lyme Disease']", - "diseases_list": [ - "Lyme Disease" - ], - "enrollment": "66.0", - "inclusion_criteria": "inclusion criteria: \n\n You may be eligible for this study if you: \n\n Are at least 18 years of age. \n\n Are seronegative for antibodies against B. burgdorferi antigens by Western Blot at enrollment. \n\n Have documented history of acute Lyme disease. \n\n Have had a rash (erythema migrans) that resembles a bullseye. This skin aberration usually occurs after a tick bite in late spring, summer, or early fall and is sometimes accompanied by fatigue, fever, headache, mild stiff neck, arthralgia or myalgia. \n\n Have had one or more clinical features typical of Lyme disease acquired in the United States (see technical summary) \n\n Have had one or more of the following symptoms and conditions that have persisted for at least 6 months (but less than 12 years) and are not attributable to another cause or condition: a) widespread musculoskeletal pain and fatigue that began coincident with or within 6 months following initial infection with B. burgdorferi. b) certain neurologic symptoms including memory impairment and nerve pain, beginning within 6 months following initial infection with B. burgdorferi. \n\n Have had a physician-documented history of prior antibiotic treatment with a currently recommended antibiotic regimen. \n\n ", - "exclusion_criteria": ": \n\n You will not be eligible for this study if you: \n\n Have previously enrolled in this study. \n\n Are pregnant, lactating, or unable to use birth control measures during the treatment period of this study. \n\n Are taking chronic medication that could interfere with evaluation of symptoms. \n\n Are taking or have taken various medications that could interfere with the evaluation of symptoms (see technical summary). \n\n Are hypersensitive to ceftriaxone or doxycycline. \n\n Have active inflammatory synovitis. \n\n Have another disease that could account for symptoms of acute Lyme disease. \n\n Have another serious or active infection. \n\n Are unable to tolerate an IV. \n\n Have tested positive for Borrelia DNA in plasma or cerebrospinal fluid at the time of initial evaluation for study. \n\n Have tested seropositive by Western Blot (these patients may be offered enrollment in seropositive study).", - "brief_summary": "Lyme disease is the most common tick-borne disease in the United States. It is caused by the spirochete Borrelia burgdorferi. It may exist in a chronic form and be the result of: 1) persistent infection by B. burgdorferi; 2) damage caused by the original infectious process; or 3) the presence of coinfection with another organism transmitted by Ixodes ticks. The purpose of this study is to determine the safety and effectiveness, in seronegative patients, of intensive antibiotic treatment in eliminating symptoms of Chronic Lyme Disease (CLD).", - "NCTID": "NCT00000938" - }, - { - "brief_title": "Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis", - "phase": "Phase 3", - "drugs": "['Ceftriaxone', 'Doxycycline']", - "drugs_list": [ - "Ceftriaxone", - "Doxycycline" - ], - "diseases": "['Lyme Neuroborreliosis']", - "diseases_list": [ - "Lyme Neuroborreliosis" - ], - "enrollment": "", - "inclusion_criteria": "inclusion criteria: \n\n Neurological symptoms and/or findings consistent with neuroborreliosis and at least one of the following fulfilled: \n\n Intrathecal production of borrelia antibodies; \n\n White cell count in cerebrospinal fluid (CSF) > 5/mm3; \n\n Significant rise in borrelia antibodies in two serum samples collected from a patient with at least 3 weeks interval; \n\n Verified acrodermatitis chronica atrophicans. \n\n ", - "exclusion_criteria": ": \n\n Allergy to the contents in the medication, or earlier type I reaction to penicillin. \n\n Treatment with cephalosporins, penicillin or tetracyclins during the last 14 days \n\n Pregnancy or breastfeeding \n\n Age < 18 years", - "brief_summary": "The aim of this study is to compare parenteral ceftriaxone and oral doxycycline in the treatment of neuroborreliosis in a randomized controlled trial.", - "NCTID": "NCT00138801" - }, - { - "brief_title": "Human Anaplasmosis in Eastern France", - "phase": "", - "drugs": "['Blood sampling']", - "drugs_list": [ - "Blood sampling" - ], - "diseases": "['Anaplasmosis', 'Tick-borne Disease', 'Ehrlichia']", - "diseases_list": [ - "Anaplasmosis", - "Tick-borne Disease", - "Ehrlichia" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: \n\n patient with at least one of following symptoms : fever or muscular pain or articular pain or respiratory signs or neurological signs or meningitis or erythema occurring during the three weeks after a tick bite- \n\n Or \n\n patient with fever with at least one of following criteria : thrombocytopenia, leucopenia, hepatitis, without any other cause that can explain these abnormalities. \n\n Or \n\n patient with tick-borne encephalitis, or primary stage Lyme borreliosis \n\n ", - "exclusion_criteria": ": \n\n children less that 10 years \n\n pregnancy \n\n patients with an other diagnosis that can explain clinical symptoms or biological abnormalities \n\n antibiotherapy with cyclins during the days before inclusion", - "brief_summary": "Anaplasmosis is a tick-borne transmitted infection. Its clinical expression include fever, cytopenia and hepatitis.This infection was initially described in United States. In Europe, its epidemiology is not well known. Some isolated cases have been diagnosed in several country, were the tick Ixodes ricinus is known to transmitted another infection :the Lyme borreliosis.The purpose of our study is to look systematically for Anaplasmosis, in patient living in Eastern France, and presenting with compatible clinical symptoms using a new diagnosis tool : PCR in blood samples. So we will have new data about epidemiology in our country and the clinical symptoms that are associated with Anaplasmosis.", - "NCTID": "NCT01013636" - }, - { - "brief_title": "Analysis of Lyme Disease Lesions", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Erythema Migrans Lesions', 'Erythema Migrans']", - "diseases_list": [ - "Erythema Migrans Lesions", - "Erythema Migrans" - ], - "enrollment": "27.0", - "inclusion_criteria": "inclusion criteria: \n\n Patients: \n\n Age greater than or equal to 18 years \n\n Diagnosis of EM - an expanding annular lesion, at least 5 cm in diameter on a person with a history of exposure to the disease. \n\n Exposure is defined as having been (less than or equal to 30 days before onset of EM) in wooded, brushy, or grassy areas (i.e., potential tick habitats) in an area in which Lyme disease is endemic. \n\n A history of tick bite is not required. \n\n The area of the erythema migrans lesion is suitable for biopsy. This excludes biopsies on the face, neck, scalp, and over the tibia. \n\n Not know to be positive for RPR, HIV, HBsAg or HCV \n\n Able to give consent \n\n Healthy Volunteers: \n\n Age greater than or equal to 18 years \n\n Not positive for RPR, HIV, HBsAg or HCV. \n\n Able to give consent \n\n ", - "exclusion_criteria": ": \n\n Patients: \n\n Antibiotic therapy for the current episode of Lyme disease \n\n Oral corticosteroids within the past 2 weeks \n\n History of severe skin disease (such as psoriasis, atopic dermatitis) in the last year. \n\n Diagnosis of diabetes, active cancer, or autoimmune diseases. \n\n Investigational drugs in the past month \n\n History of forming large thick scars after skin injuries or surgery \n\n History of excessive bleeding after cuts or procedures or on anticoagulation. \n\n Use of steroid cream/ointment at the rash. \n\n Healthy Volunteers: \n\n History of Lyme disease, or serological evidence for Lyme disease \n\n No oral corticosteroids within the past 2 weeks \n\n History of severe skin disease (such as psoriasis, atopic dermatitis) in the last year. \n\n Diagnosis of diabetes, cancer, autoimmune diseases. \n\n Investigational drugs in the past month \n\n History of forming large thick scars after skin injuries or surgery \n\n No history of excessive bleeding after cuts or procedures or on anticoagulation.", - "brief_summary": "This study will analyze cells from erythema migrans lesions, the bull's eye rash of Lyme disease. Little is known about what happens in the skin when it is infected with Borrelia burgdorferi, the bacteria that cause Lyme disease. This study will examine and compare laboratory findings in skin biopsies from people with Lyme disease and from healthy normal volunteers to try to better understand the infection.~Healthy volunteers and people with untreated erythema migrans rash who are 18 years of age or older may be eligible for this study.~All participants undergo a clinical examination, blood tests, between two to four skin biopsies (removal of a small piece of tissue for laboratory examination), and complete two health questionnaires. The biopsies are taken from the erythema migrans lesion in patients with Lyme disease and from skin on the legs, forearms, buttocks, or side from healthy volunteers. To collect the tissue, the skin at the biopsy site is numbed with injection of a local anesthetic and a sharp instrument is then used to remove a round plug of skin about the size of a pencil eraser. The wound may be closed with one or two sutures, or allowed to heal without sutures. The sutures are removed after a week to 10 days.~Patients with Lyme disease receive treatment for their condition. In addition, at the time the sutures are removed and at 4 weeks, 6 months, and 12 months after their first visit they fill out a questionnaire and have additional blood tests.", - "NCTID": "NCT00132327" - }, - { - "brief_title": "Study and Treatment of Post Lyme Disease (STOP-LD)", - "phase": "Phase 3", - "drugs": "['Antibiotics']", - "drugs_list": [ - "Antibiotics" - ], - "diseases": "['Lyme Disease']", - "diseases_list": [ - "Lyme Disease" - ], - "enrollment": "55.0", - "inclusion_criteria": "inclusion criteria: \n\n You may be eligible for this study if you: \n\n Are between 18 and 65 years of age. \n\n Are a resident of Long Island or greater NY metropolitan area. \n\n Are fluent in English. \n\n Have a history of Lyme Disease. \n\n Have completed antibiotic treatment for Lyme Disease 6 or more months before starting the study. \n\n Have severe fatigue. \n\n Are not pregnant or planning to be pregnant. \n\n ", - "exclusion_criteria": ": \n\n You will not be eligible for this study if you: \n\n Have or have had major medical, neurologic, or psychiatric disorder. \n\n Have had prior chronic pain, fatigue, or recurrent severe headaches before the onset of Lyme Disease. \n\n Have had Fibromyalgia Syndrome. \n\n Have a history of sleep apnea, narcolepsy, or other serious sleep disorder. \n\n Have a learning disability. \n\n Have had head trauma requiring hospitalization. \n\n Have symptomatic gallbladder disease. \n\n Are anemic. \n\n Abuse alcohol or illicit drugs. \n\n Have been treated with another antimicrobial agent for Lyme Disease within 6 months of study. \n\n Need to be receiving systemic steroid therapy during drug administration and follow-up. \n\n Have used benzodiazepines within 1 month of study entry. \n\n Are allergic to Beta lactams (a class of antibiotics).", - "brief_summary": "The purpose of this study is to see how well antibiotics work in reducing chronic fatigue symptoms, such as tiredness, in patients that were treated for Lyme Disease. Fatigue is a common symptom of Lyme Disease. When fatigue does not improve after treatment, patients are considered to have Post Lyme Syndrome (PLS). The chronic fatigue seen in these patients appears to be related to the initial infection which causes Lyme Disease. It is believed, but not proven, that treatment with antibiotics may be effective in relieving chronic fatigue in PLS patients.", - "NCTID": "NCT00000937" - }, - { - "brief_title": "Study on Early Lyme Neuroborreliosis", - "phase": "", - "drugs": "['ceftriaxone']", - "drugs_list": [ - "ceftriaxone" - ], - "diseases": "['Nervous System Lyme Borreliosis']", - "diseases_list": [ - "Nervous System Lyme Borreliosis" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n erythema migrans within 4 months before neurologic involvement and pleocytosis in patients >15 years old \n\n ", - "exclusion_criteria": ": \n\n pregnancy \n\n lactation \n\n history of adverse reaction to a beta-lactam antibiotic", - "brief_summary": "The purpose of this study is to determine clinical course and the sequelae of early Lyme neuroborreliosis after treatment with ceftriaxone.", - "NCTID": "NCT00910533" - }, - { - "brief_title": "Tick-borne Encephalitis and Positive Borrelial Antibodies", - "phase": "", - "drugs": "['Doxycycline', 'Symptomatic therapy', 'Questionnaire']", - "drugs_list": [ - "Doxycycline", - "Symptomatic therapy", - "Questionnaire" - ], - "diseases": "['Tick-borne Encephalitis']", - "diseases_list": [ - "Tick-borne Encephalitis" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n 18 years or older \n\n clinical picture compatible with tick-borne encephalitis, \n\n clear cerebrospinal fluid, \n\n cerebrospinal pleocytosis (leucocytes in cerebrospinal fluid >5 x 106/)L, \n\n positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against tick-borne encephalitis virus, \n\n positive serum IgG antibodies against Lyme borreliae. \n\n ", - "exclusion_criteria": ": \n\n isolation of B.burgdorferi sensu lato from cerebrospinal fluid, \n\n positive intrathecal borrelial antibody production index, \n\n seroconversion of borrelial IgG antibodies, \n\n presence of erythema migrans and/or borrelial lymphocytoma in the last month, \n\n Bannwarth syndrome.", - "brief_summary": "In Slovenia, tick-borne encephalitis and Lyme borreliosis are both endemic diseases with high incidence rates and they are both transmitted by a bite of infected Ixodes ricinus tick. In clinical practice, tick-borne encephalitis is confirmed by demonstration of tick-borne encephalitis antibodies in serum of a patient with compatible clinical presentation and cerebrospinal pleocytosis. Patients with Lyme meningitis or meningoradiculitis also have cerebrospinal pleocytosis, however the presence of borrelial antibodies in serum does not attest Lyme neuroborreliosis.~Patients with tick-borne encephalitis and positive borrelial antibodies in serum, but not fulfilling criteria for Lyme neuroborreliosis, are often being treated with antibiotics in several European countries due to the possibility of double infection. The investigators hypothesise that such patients do not benefit from antibiotics. Such an approach may appear safe regarding the possibility of borrelial infection, however it can also be associated with detrimental consequences such as antibiotic related adverse reactions, negative epidemiological impact on bacterial resistance, and intravenous catheter related complications.", - "NCTID": "NCT02463942" - }, - { - "brief_title": "Tick-borne Illness and Clothing Study of Rhode Island", - "phase": "", - "drugs": "['Permethrin Impregnated Clothing']", - "drugs_list": [ - "Permethrin Impregnated Clothing" - ], - "diseases": "['Tick Bites', 'Tick-borne Diseases']", - "diseases_list": [ - "Tick Bites", - "Tick-borne Diseases" - ], - "enrollment": "135.0", - "inclusion_criteria": "inclusion criteria: \n\n over 18 years of age, \n\n spending an average of 10 or more hours of outdoor work per week during peak tick season, and \n\n completion of written informed consent. \n\n ", - "exclusion_criteria": ": \n\n pregnancy or a planned pregnancy during the follow-up period (since exposure to an insecticide is involved), \n\n non-English speakers, or \n\n having a known allergy or sensitivity to insecticides", - "brief_summary": "Lyme and other tick-borne diseases pose a significant health threat to outdoor workers. This study is a double-blind randomized controlled trial of outdoor workers in Rhode Island and the surrounding area that will address the following study aims: 1) Evaluate the effectiveness of LLPI clothing in preventing tick bites among outdoor workers in Lyme endemic areas; 2) Measure the urine levels of permethrin metabolites in study subjects; and 3) Measure the loss over time of knockdown activity against ticks and of permethrin in LLPI clothing.", - "NCTID": "NCT02613585" - }, - { - "brief_title": "Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis", - "phase": "", - "drugs": "['doxycycline', 'ceftriaxone']", - "drugs_list": [ - "doxycycline", - "ceftriaxone" - ], - "diseases": "['Suspected Early Lyme Neuroborreliosis']", - "diseases_list": [ - "Suspected Early Lyme Neuroborreliosis" - ], - "enrollment": "200.0", - "inclusion_criteria": "inclusion criteria: \n\n age >15 years \n\n erythema migrans in 4 months period before neurologic symptoms \n\n normal CSF cell count \n\n absence of more defined clinical symptoms or signs for CNS involvement (radicular pain, meningeal signs, peripheral facial palsy). \n\n ", - "exclusion_criteria": ": \n\n pregnancy \n\n lactation \n\n allergy on doxycycline and ceftriaxone \n\n immune deficiency.", - "brief_summary": "The investigators will compare doxycycline and ceftriaxone in treatment of patients with suspected early Lyme neuroborreliosis and normal CSF cell count. The study hypothesis is that the efficacy and adverse effects of both antibiotics are comparable.", - "NCTID": "NCT00942006" - }, - { - "brief_title": "Duration of Antibiotic Treatment of Erythema Migrans", - "phase": "", - "drugs": "['doxycycline', 'doxycycline', 'placebo']", - "drugs_list": [ - "doxycycline", - "doxycycline", - "placebo" - ], - "diseases": "['Erythema Chronicum Migrans']", - "diseases_list": [ - "Erythema Chronicum Migrans" - ], - "enrollment": "306.0", - "inclusion_criteria": "inclusion criteria: \n\n solitary erythema migrans in patients > 15 years \n\n ", - "exclusion_criteria": ": \n\n a history of Lyme borreliosis in the past \n\n pregnancy or lactation \n\n immunocompromised status \n\n serious adverse event to doxycycline \n\n taking antibiotic with antiborrelial activity within 10 days \n\n multiple erythema migrans or extracutaneous manifestations of Lyme borreliosis", - "brief_summary": "The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.", - "NCTID": "NCT00910715" - }, - { - "brief_title": "TORPEDO Study: A Study on Rapid Effect of Tocilizumab in Patients With Rheumatoid Arthritis With an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) or Anti-TNF", - "phase": "Phase 3", - "drugs": "['tocilizumab [RoActemra/Actemra]', 'placebo', 'tocilizumab [RoActemra/Actemra]']", - "drugs_list": [ - "tocilizumab [RoActemra/Actemra]", - "placebo", - "tocilizumab [RoActemra/Actemra]" - ], - "diseases": "['Rheumatoid Arthritis']", - "diseases_list": [ - "Rheumatoid Arthritis" - ], - "enrollment": "103.0", - "inclusion_criteria": "inclusion criteria: \n\n adult patients >/= 18 years of age \n\n active moderate or severe rheumatoid arthritis of <10 years duration with inadequate response to methotrexate or anti-TNF \n\n on methotrexate treatment for at least 10 weeks, at least 8 weeks on stable dose \n\n patients receiving oral corticosteroids and/or NSAIDs should be at stable dose for 4 weeks \n\n ", - "exclusion_criteria": ": \n\n rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA \n\n functional class IV by ACR classification \n\n history of inflammatory joint disease other than RA \n\n previous treatment with cell-depleting therapies, abatacept or rituximab \n\n active current or history of recurrent infection, or any major episode of infection requiring hospitalization or treatment with iv antibiotics <4 weeks or oral antibiotics <2 weeks prior to screening", - "brief_summary": "This study will assess the onset and maintenance of effect of tocilizumab on relief in patients with active moderate or severe rheumatoid arthritis who have had an inadequate response to DMARDs or anti-TNF. For the first, double-blind, part of the study patients will be randomized to receive an iv infusion of either 8mg/kg tocilizumab or placebo. After 4 weeks this will be followed by 11 months treatment with tocilizumab 8mg/kg iv infusion every 4 weeks. Methotrexate or DMARD therapy will be continued throughout study treatment. Target sample size is >100.", - "NCTID": "NCT00977106" - }, - { - "brief_title": "TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223)", - "phase": "Phase 4", - "drugs": "['Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)']", - "drugs_list": [ - "Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)" - ], - "diseases": "['Encephalitis, Tick-Borne']", - "diseases_list": [ - "Encephalitis", - "Tick-Borne" - ], - "enrollment": "314.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects who participated in Study 223 will be eligible for participation in this study if: \n\n they understand the nature of the study, agree to its provisions and provide written informed consent \n\n they received the first booster vaccination with FSME-IMMUN 0.5ml during the course of study 223 \n\n blood was drawn after their first booster vaccination in Study 223. \n\n ", - "exclusion_criteria": ": \n\n Subjects will be excluded from participation in this study if they: \n\n received any TBE vaccination since their first booster vaccination with FSME-IMMUN 0.5ml \n\n have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis) since their first booster vaccination with FSME-IMMUN 0.5ml \n\n are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their first booster vaccination with FSME-IMMUN 0.5ml \n\n have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages). \n\n Subjects will not be eligible for booster vaccination if they: \n\n are not clinically healthy, (i. e. the physician would have reservations vaccinating with FSME-IMMUN 0.5ml outside the scope of a clinical trial) \n\n suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions \n\n are females of childbearing potential and are pregnant or breastfeeding before the booster vaccination (positive pregnancy test result at the medical examination before the booster vaccination) \n\n have shown an allergic reaction to one of the components of the vaccine since their first booster vaccination in Study 223 \n\n are simultaneously participating in another clinical trial including administration of an investigational product within six weeks prior to the booster vaccination until the end of the study \n\n do not agree to keep a Subject Diary. \n\n Subjects who meet the eligibility criteria, but have a febrile illness (body temperature >= 38.0\u00b0C, measured orally) at the scheduled time of vaccination, will not be vaccinated until their body temperature returns to normal. \n\n Subjects who have been administered any vaccination within 2 weeks prior to the booster vaccination will not be vaccinated until an interval of two weeks has passed. \n\n If subjects have received antipyretics within 4 hours prior to the scheduled time of vaccination, the vaccination should be performed at a later time. \n\n If a subject had a tick-bite within 4 weeks of the scheduled booster vaccination, the vaccination shall be delayed such that an interval of 4 weeks has passed since the tick-bite in order to avoid any interference with diagnostic assays in the event of a TBE infection. \n\n If a subject has donated blood or plasma or has received a blood transfusion or immunoglobulins within 4 weeks of the scheduled booster vaccination, the vaccination shall be delayed until an interval of 4 weeks has passed.", - "brief_summary": "The purpose of this study is to assess:~TBE antibody persistence 24, 34, 46 and 58 months (as applicable) after the first booster TBE vaccination with FSME-IMMUN 0.5ml given in Study 223, by means of ELISA (IMMUNOZYM FSME IgG) and Neutralization test (NT),~TBE antibody response to a second booster vaccination with FSME-IMMUN 0.5ml in the present study, by means of ELISA and NT,~Safety of FSME-IMMUN 0.5ml after the second booster vaccination.", - "NCTID": "NCT00503529" - }, - { - "brief_title": "Vaccine Study for Tick-Borne Encephalitis Virus (TBEV)", - "phase": "Phase 2", - "drugs": "['FSME-IMMUN 0.5ml Baxter']", - "drugs_list": [ - "FSME-IMMUN 0.5ml Baxter" - ], - "diseases": "['Tick-Borne Encephalitis', 'Encephalitis, Tick-Borne', 'Tick-Borne Disease', 'Glycoprotein E, Flavivirus', 'NSI Protein, Flavivirus']", - "diseases_list": [ - "Tick-Borne Encephalitis", - "Encephalitis", - "Tick-Borne", - "Tick-Borne Disease", - "Glycoprotein E", - "Flavivirus", - "NSI Protein", - "Flavivirus" - ], - "enrollment": "69.0", - "inclusion_criteria": "inclusion criteria: \n\n All subjects must meet the following criteria at study entry: \n\n Be engaged in activities that place them at potential risk of occupational exposure to TBEV in its viable form at one of the participating intramural laboratories of NIAID \n\n Be 18 years of age or older at the time of the first immunization. \n\n Comprehend the study requirements. \n\n Provide written informed consent to participate in this study. \n\n Be in good health as determined by the Investigator, based upon medical history and a targeted physical examination. \n\n Have a stable health status as determined by the Investigator. \n\n Have access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device (i.e., a common use phone serving multiple rooms or apartments). \n\n Express availability for the required study period, and ability to attend scheduled visits. \n\n ", - "exclusion_criteria": ": \n\n The following criteria should be checked at the time of the study entry. If any apply, the subject will not be included in the study: \n\n The subject must not be participating in any other trial of an investigational drug or vaccine for 1 month prior to the first injection through until 21 days after the third injection. (Given the nature of the work these study subjects engage in, exemptions to this proscription may be granted on a case by case basis after discussion between the Investigator and the IRB.) \n\n The presence on the day of immunization of an oral temperature of >101.2 degrees F or acute symptoms other than mild severity. \n\n Active systemic infectious process as determined by review of systems and physical examination. The subject may be enrolled at a later date once the illness has resolved. \n\n Known immune suppression, such as that associated with human immunodeficiency virus infection, or other condition, to the extent that, in the opinion of the Investigator, the subject is likely to have a poor response to the vaccine. This information will be obtained by history only. Serologic screening for these diseases will not be performed. \n\n Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the Investigator to render the potential subject unable/unlikely to report promptly any adverse reactions to the vaccine. \n\n Current diagnosis of leukemia, Hodgkin s disease, non-Hodgkin s lymphoma, or any other cancer, autoimmune disease such as lupus, which is in and of itself a cause of immunosuppression to the point that, in the opinion of the Investigator, the subject is likely to have a poor response to the vaccine. \n\n Currently receiving systemic immunosuppressive chemotherapy or immunotherapy (including glucocorticoids) resulting in immune suppression to the point that, in the opinion of the Investigator, the subject is likely to have a poor response to the vaccine. \n\n Any neurological condition in which (in the opinion of the Investigator) the integrity of the blood brain barrier may have been compromised. \n\n Licensed vaccines are not exclusionary but should be given at least 14 days before or after immunization (applies to each of the 3 scheduled TBEV injections) for inactivated vaccines and 30 days before or after immunization with any live vaccines. This is in order to avoid potential confusion of adverse reactions. (Given the nature of the work these study subjects engage in, exemptions to this proscription may be granted on a case-by-case basis after discussion between the Investigator and the IRB.). \n\n Previous anaphylactic reaction to any TBE vaccine. \n\n Known or suspected anaphylactic reaction to any constituent of FSME IMMUN, to include formaldehyde, protamine sulfate, gentamicin and neomycin, or current egg allergy. \n\n Known pregnancy, or anticipating becoming pregnant in the first 8 months of the study or a positive urine beta-human chorionic gonadotropin (beta hCG) test result prior to immunization. If subjects become pregnant at some point in time after the 1st injection, no further injections will be given until after the pregnancy is completed, they are no longer nursing or have a negative beta-hCG result. \n\n Lactating or nursing. \n\n Women of child bearing potential (defined as pre-menopausal who have not undergone either hysterectomy or tubal ligation) who lack a history of reliable contraceptive practices. Reliable contraceptive practices (for the first 8 months of the study and within 21 days prior to or 42 days after booster immunizations) include: \n\n Consistent abstinence from heterosexual activity \n\n Consistent use of combined or progestogen oral contraceptives \n\n Injectable progestogen \n\n Implants of levonorgestrel \n\n Estrogen or estrogen/progestogen vaginal ring \n\n Percutaneous contraceptive patches \n\n Intrauterine device (IUD) or intrauterine system (IUS) \n\n Successful vasectomy of the sole male partner, or \n\n Double barrier method (condom or occlusive cap plus spermicidal agent) \n\n A history of a prior infection with TBEV or previously receiving a TBE vaccine will not be considered as an exclusionary criterion for immunization through this protocol. However, these subjects antibody titer data will not be included in the statistical analysis. \n\n Any other conditions, which in the Investigator s judgment, might result in an increased risk to the subject, or would affect their participation in the study. Additionally the Investigator has the ability to exclude a subject if for any reason he/she feels the subject is not a good candidate for the study or will not be able to follow study procedures.", - "brief_summary": "This was an open label trial of a non-US licensed vaccine for tick-borne encephalitis. The vaccine was licensed by Baxter, and now following an acquisition by Pfizer Inc in Vienna, Austria since 2001, and has an extensive safety record in multiple European countries. Field effectiveness studies suggest > 99 percent protection against disease transmitted by the natural routes of either tick bite or ingestion of contaminated, unpasteurized milk. The vaccine is also considered to be effective against laboratory exposures and is used routinely for this purpose in European laboratories. The US Centers for Disease Control and Prevention and the National Institutes of Health acknowledge the effectiveness of the vaccine by allowing those who have received it to study tick-borne encephalitis virus (TBEV) in isolation facilities rated at BSL-3 rather than the more stringent BSL-4, with the exception of the Russian Spring-Summer Encephalitis strain. Subjects were recruited from personnel at 2 intramural campuses of the National Institute of Allergy and Infectious Diseases who may be exposed accidentally to any strain or serotype of viable TBEV. Approximately 160 individuals were eligible to participate. The rapid immunization schedule (injections on Days 0, 14, and 161) was used and subjects had labs drawn 21 days after the 2nd, 3rd and 4th vaccine injections to determine seroconversion. Subjects that seroconverted to TBEV were offered a booster dose of the vaccine 3 years from the date of receipt of the third dose of the vaccine. Subjects that were seropositive at entry into the study were offered a booster dose of the vaccine every 3 years from Day 0.", - "NCTID": "NCT01031537" - }, - { - "brief_title": "Treatment of Viral Hemorrhagic Fevers With Intravenous Ribavirin in Military Treatment Facilities", - "phase": "Phase 2", - "drugs": "['Ribavirin (Virazole) Injection']", - "drugs_list": [ - "Ribavirin (Virazole) Injection" - ], - "diseases": "['Lassa Fever', 'Crimean-Congo Hemorrhagic Fever']", - "diseases_list": [ - "Lassa Fever", - "Crimean-Congo Hemorrhagic Fever" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n An individual will be enrolled in this study if the patient: \n\n Meets the case definition for a probable or a suspected case of CCHF or LF (see below). \n\n Has read and signed the Informed Consent. \n\n Is at least 18 years of age (17, if active military) and not greater than 65 years of age. \n\n Has a blood sample drawn and a type and cross-match ordered for transfusion. \n\n Agrees to collection of required specimens. \n\n Agrees to report any Adverse Events, Serious and Unexpected Adverse Events for the duration of the study. \n\n Agrees to a follow-up visit and to donate blood and urine specimens at day 14 (\u00b12 days) and once between days 28 and 60 after the first dose of IV Ribavirin and to all follow-up visits for anemia or other medical conditions as required by the attending physician. \n\n Woman of childbearing age must have a pregnancy test performed. If negative, she must agree not to become pregnant during treatment and for 7 months after receiving Ribavirin. She also must agree to not breast feed during treatment and for 7 months after receiving Ribavirin. Two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period. She will be counseled concerning the risks of IV Ribavirin versus no treatment if the pregnancy test is positive. \n\n Man agrees not to have intercourse with pregnant woman during treatment and for 7 months after receiving Ribavirin, and take precautions to avoid producing pregnancies during treatment and for 7 months after receiving Ribavirin. At least two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period to avoid a pregnancy. \n\n Has a hemoglobin greater than or equal to10 g/dL before starting IV Ribavirin \n\n Note: Malaria should be excluded as a possibility for illness in patients suspected to have VHF. \n\n Probable Case of Crimean-Congo Hemorrhagic Fever: \n\n All subjects will have a history of possible exposure to CCHF, either having: \n\n Worked or slept outdoors in the CCHF endemic area within 2 weeks of illness onset, with or without a history of tick-bite or tick exposure, (Endemic area includes, but not necessarily limited to: Saudi Arabia, Kuwait, Oman, United Arab Emirates, Iran, Iraq, Turkey, Greece, Bulgaria, Albania, Montenegro, the Kosovo region of Serbia, Bosnia-Herzegovina, Macedonia, the whole of Africa, India, Pakistan, Afghanistan, Kazakhstan, Uzbekistan, Kyrgyzstan, Tajikistan, Turkmenistan, Azerbaijan, Georgia, the Crimean region of the Ukraine, Rostov-Don and Astrakhan regions of Russia, and the Xinjiang [northwestern] region of the People's Republic of China), OR \n\n Handled blood or freshly butchered meat of domestic livestock in CCHF endemic area during 2 weeks before the onset of illness, OR \n\n Had direct contact with blood, tissues, secretions, or excretions of a CCHF patient (suspected or confirmed), including laboratory specimens, OR \n\n Worked with the virus in the laboratory setting and have a clinical syndrome consistent with CCHF as defined by: \n\n Acute illness with fever and at least two of these symptoms: myalgia, low back pain, and headache, \n\n And the appearance of three or more of the following five groups of signs/symptoms: \n\n Hemorrhage (one or more petechiae, ecchymoses, purpura, gingival bleeding, epistaxis, gastrointestinal tract bleeding), \n\n Elevated AST levels (above the upper limits of normal for the laboratory), \n\n Thrombocytopenia (below the lower limits of normal), \n\n Hypotension (systolic pressure < 90 mm Hg), or \n\n Azotemia, renal failure (serum creatinine above the upper limits of normal). \n\n Prognostic indicators exist for subjects at increased risk of severe CCHF. Any of these indicators occurring in the first 5 days of illness, predict a mortality greater than 90% (Swanepoel et al., 1989). Patients with these prognostic indicators may benefit most from drug therapy, if resources become limiting: \n\n WBC > 10,000/mm3 \n\n Platelet count < 20 x 103/mm3 \n\n AST > 200 U/L \n\n ALT > 150 U/L \n\n APTT > 60 seconds \n\n Fibrinogen < 110 mg/dL \n\n Probable Case of Lassa Fever: \n\n All subjects will have a history of possible exposure to Lassa fever, either having: \n\n By residence or travel in an endemic area where contact with rodents was possible within 3 weeks of onset of illness, (Endemic area includes, but not necessarily limited to: Sierra Leone, Liberia, Nigeria, Mali, Central African Republic, and Guinea.) or \n\n Contact with a suspect patient or their body fluids (including laboratory specimens) within 3 weeks of symptom onset, or \n\n Worked with the virus in the laboratory setting. And have \n\n A negative malaria smear. And have \n\n Signs and symptoms compatible with Lassa fever, either: \n\n Fever plus pharyngitis plus retrosternal pain plus proteinuria (positive predictive value of 81% when these three criteria are met, McCormick et al., 1987a,b),OR \n\n Fever plus unexplained mucosal bleeding, OR \n\n Fever plus unexplained edema of the face and neck, OR \n\n Suspected Case of CCHF or LF \n\n Have a clinical syndrome consistent with CCHF or LF, meeting most of the above criteria of a probable case and the patient has an epidemiological history of potential exposure to the bunyavirus or arenavirus (i.e., recent field duty and/or other individuals in his troop have CCHF or LF). \n\n ", - "exclusion_criteria": ": \n\n Has known intolerance to Ribavirin. \n\n Is irreversibly ill on presentation, as defined by presence of profound shock (shock which does not respond to supportive therapy within 3 hours after admission). \n\n Has hemoglobin less than 10 g/dL that cannot be corrected to 10 g/dL before initiation of IV Ribavirin \n\n Has history of hemoglobinopathies (i.e., sickle-cell anemia or thalassemia major). \n\n Has history of autoimmune hepatitis. \n\n Has a calculated serum creatinine clearance of < 30 mL/min. \n\n History of such as second or third degree heart block or sick sinus syndrome and without a pacemaker and no capability of a pacemaker placement or Wolfe-Parkinson-White Syndrome. \n\n A sinus bradycardia of less than 40 beats per minute. \n\n Is currently being treated with Didanosine (ddI). ddI must be discontinued before starting IV Ribavirin. \n\n Relative ", - "brief_summary": "This is a Phase 2 study of the safety and efficacy of Intravenous (IV) Ribavirin in treating patients presenting with a probable or suspected case of viral hemorrhagic fever (either Crimean Congo or Lassa Fever) at a military medical treatment hospital. All patients will be treated with a 10 day course of IV Ribavirin if they meet all the inclusion and none of the exclusion criteria.", - "NCTID": "NCT00992693" - }, - { - "brief_title": "Position of Children During Urine Collection: Evaluation Study", - "phase": "", - "drugs": "['upright position']", - "drugs_list": [ - "upright position" - ], - "diseases": "['Urinary Infection']", - "diseases_list": [ - "Urinary Infection" - ], - "enrollment": "803.0", - "inclusion_criteria": "inclusion criteria: \n\n Children aged 2 - 36 months \n\n Non-toilet-trained children \n\n Indication to bag urine collection with the following criteria : \n\n fever \u2265 38.5 \u00b0C \n\n unexplained fever \n\n and at least 1 of the following criteria for girls and uncircumcised boys, at least 2 criteria for circumcised boys : \n\n age \u2264 12 months \n\n fever \u2265 48 hours \n\n poorly tolerated fever (chills \u00b1 cyanosis \u00b1 pronounced weakness\u2026) \n\n preceding episode of tract urine infection \n\n ", - "exclusion_criteria": ": \n\n Parents opposed to the participation of their children in the study \n\n Diarrhea \n\n Current antibiotic treatment or during the 8 preceding days of the urine collection \n\n Genitals / perineal anomaly", - "brief_summary": "Urinary tract infection (UTI) is a frequently suspected cause of fever in young children, justifying urine cultures. Sampling procedures are decisive for the reliability of UTI diagnosis. Even though official guidelines recommend clean catch method, catheterization or suprapubic aspiration, urine bag collection remains widely used. In our experience, the rate of contaminated bag-obtained cultures reaches 30.2 %. In a recent study, the investigators have noticed that the rate of contaminated urine cultures was lower when children were kept in an upright position at the time of urine collection. The upright position could explain this decrease, perineum being less in contact with urine. These results are borderline significant, the investigators would like to confirm them with a specific study.", - "NCTID": "NCT01862822" - } - ], - "1": [ - { - "brief_title": "Study of Lyme Neuroborreliosis", - "phase": "Phase 4", - "drugs": "['Doxycycline', 'Ceftriaxone']", - "drugs_list": [ - "Doxycycline", - "Ceftriaxone" - ], - "diseases": "['Lyme Neuroborreliosis']", - "diseases_list": [ - "Lyme Neuroborreliosis" - ], - "enrollment": "210.0", - "inclusion_criteria": "inclusion criteria for definite Lyme neuroborreliosis (Criteria 1-3 or 1 and 4 fulfilled): \n\n Neurological symptoms suggestive of LNB without other obvious reasons \n\n CSF pleocytosis (>4 leukocytes per mikrol) \n\n Intrathecal production of B. burgdorferi specific antibodies \n\n Detection of B. burgdorferi DNA in central spinal fluid \n\n Inclusion Cirteria for possible LNB (criteria 1 and 2 or 3 fullfilled): \n\n Neurological symptoms suggestive of LNB wihtout other obvious reasons \n\n Production of B. burgdorferi spesific antibodies in serum \n\n Erythema migrans during the previous three months \n\n ", - "exclusion_criteria": ": \n\n pregnancy and breastfeeding \n\n women planning to get pregnant in two months \n\n age under 18 \n\n handicapped persons \n\n prisoners \n\n use of any antibiotics two weeks before study treatments begins \n\n allergy for tetracyclines or cephalosporins", - "brief_summary": "The main purpose of this study is to determine whether four weeks treatment with oral doxycycline is as equally effective as three weeks treatment with intravenous ceftriaxone in patients with Lyme neuroborreliosis. The other purpose is to improve laboratory diagnostics of Lyme neuroborreliosis and further define the manifestations and epidemiology of the disease in Finland.", - "NCTID": "NCT01635530" - } - ], - "2": [] - }, - { - "patient_id": "sigir-201529", - "patient": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", - "0": [ - { - "brief_title": "Trial of Atorvastatin on the Persistent Coronary Aneurysm in Children With Kawasaki Disease", - "phase": "Phase 2", - "drugs": "['Atorvastatin']", - "drugs_list": [ - "Atorvastatin" - ], - "diseases": "['Kawasaki Disease', 'Aneurysm, Coronary']", - "diseases_list": [ - "Kawasaki Disease", - "Aneurysm", - "Coronary" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of Kawasaki Disease with giant aneurysm \n\n Must be older than 10 years old \n\n ", - "exclusion_criteria": ": \n\n Subjects ever received coronary artery bypass graft (CABG) surgery. \n\n Subjects have active hepatitis or persistent abnormal liver function such as elevated GOT and GPT. \n\n Subjects have the past history of rhabdomyolysis. \n\n Female subjects are pregnant or plan for child-bearing during study periods.", - "brief_summary": "Background Kawasaki disease (KD) is characterized by fever, bilateral nonexudative conjunctivitis, erythema of the lips and oral mucosa, changes in the extremities, rash, and cervical lymphadenopathy. Incidence of late coronary artery aneurysms or ectasia, which may lead to myocardial infarction (MI), sudden death, or ischemic heart disease, decreased after the introduction of intravenous immunoglobulin therapy. However, significant persistent coronary arterial lesions or aneurysms may still occur in about 1-3 % of the patients.~Atorvastatin (Lipitor\u00ae), a kind of statin, is a selective competitive inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This drug had been safely and widely used for treatment of adult hyperlipidemia, prevention of coronary heart disease and familial hypercholesterolemia in childhood. In addition to the cholesterol-lowering effects, statins exerts diverse cellular, cholesterol-independent effects, including improvement in endothelial function, inhibition of neurohormonal activation, and reduction in levels of proinflammatory cytokines. Based on the above concepts, some patients with infrarenal abdominal aortic aneurysms received statin therapies and then the growth rate of aneurysms slowed down.~Therefore, the investigators may hypothesize that Atorvastatin is helpful in the regression of persistent coronary lesions in KD patients due to its effect of anti-inflammation. In NTUH, there are about 20 KD patients with coronary lesions persistent for many years. And the investigators plan to conduct the clinical trial with atorvastatin to evaluate the effects of Atorvastatin on the persistent coronary arterial lesions/aneurysms in children with Kawasaki disease including safety and efficacy.~Methods~There are around 20 KD patients eligible for this study. After they sign the IRB-approved ICF, they will be enrolled for this study. Briefly, this study is divided into three stages: screening & enrollment stage (I), treatment & follow-up stage (II) for 1 year and final data analysis stage (III). Measurements include basic vital sign, electrocardiography, liver function, muscle enzyme, inflammatory markers and echocardiography.~Predicted results~1.Oral atorvastatin therapy can effectively prevent the progression of coronary lesions in KD patients.", - "NCTID": "NCT02114099" - }, - { - "brief_title": "APC-231 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) in Pediatric Patients With Strep Throat", - "phase": "Phase 3", - "drugs": "['Amoxicillin Pulsatile Release Multiparticluate Sprinkle']", - "drugs_list": [ - "Amoxicillin Pulsatile Release Multiparticluate Sprinkle" - ], - "diseases": "['Pharyngitis']", - "diseases_list": [ - "Pharyngitis" - ], - "enrollment": "500.0", - "inclusion_criteria": "inclusion criteria: \n\n Give informed consent, assent, and documentation of patient authorization for disclosure of study results. \n\n Since all patients are below the legal age of consent, assent from the patient must be obtained (as applicable following state regulations) and written informed consent obtained from the parent or legal guardian. \n\n Age > = 6 months -12 years. \n\n A clinical diagnosis of acute tonsillitis and/or pharyngitis defined as having the clinical signs and symptoms compatible with tonsillitis and/or pharyngitis, including sore throat or difficulty feeding or swallowing or irritability that suggests the presence of a sore throat with at least one of the following: \n\n Tonsillar or pharyngeal exudate \n\n Tender cervical lymph nodes \n\n Fever or history of fever treated with antipyretics \n\n Odynophagia \n\n Uvular edema \n\n Pharyngeal Erythema of moderate or greater intensity \n\n Elevated white blood cell (WBC) >12,000/mm3 or \uf0b310% bands \n\n Red tongue and prominent papillae (Strawberry tongue) \n\n A positive rapid screening test for S. pyogenes (enzyme immunoassay; SiGNIFY\u2122 Strep A Test). \n\n Patient is an appropriate candidate for oral antibiotic therapy and can swallow the study dosage forms. \n\n Females must be non-lactating and: \n\n If of childbearing potential and sexually active, the patient must have a negative prestudy urine pregnancy test and be utilizing acceptable birth control methods throughout the study. \n\n ", - "exclusion_criteria": ": \n\n Chronic or recurrent (two weeks duration two times per year) odynophagia or enlarged tonsils secondary to viral or proven bacterial etiology. \n\n The need for hospitalization or I.V. antimicrobial therapy. \n\n Pharyngitis known or suspected to be due to a pathogen resistant to beta-lactam antimicrobials. \n\n Patients who are known carriers of S. pyogenes. \n\n Previous allergy, serious adverse reaction to, or intolerance to, penicillin or any other member of the beta-lactam class of antimicrobials. \n\n Any serious illness or concomitant condition that the investigator judges would preclude the study evaluations or make it unlikely that the course of study therapy and follow-up could be completed. This would also include: \n\n Any rapidly progressive underlying disease with a shortened life expectancy. \n\n The inability to swallow the study dosage form. \n\n Unable to understand the requirements of the study. \n\n Neutropenia (<1000 PMNs/mm3) or other known immunocompromised state. \n\n Hard chills or rigors. \n\n Seizure disorder or lowered seizure threshold. This does not exclude children with previous febrile seizures. \n\n Psychiatric condition requiring use of major tranquilizers. \n\n Pregnancy or nursing. \n\n Expectation that additional effective systemic antibacterials would be required for any condition during the duration of the study. \n\n Current drug or alcohol abuse. \n\n Receipt of any experimental drug or medical device within the previous 30 days (or are scheduled to receive any other experimental procedures during the study period). \n\n Previous treatment under this protocol. \n\n Systemic antimicrobial therapy with benzathine penicillin within 30 days or azithromycin within 14 days. \n\n Hospitalization within the month prior to study admission, during which antibacterial therapy was administered. \n\n The presence of clinically significant hematologic conditions or cardiac valvular disease. \n\n History of cardiovascular disease, renal disease, or neurological disease secondary to previous infection with S. pyogenes. \n\n Probenecid treatment or systemic steroids during the duration of the study.", - "brief_summary": "The purpose of this study is to evaluate the efficacy and safety of APC-231 QD for 7 days in the bacteriological outcome at the Test of Cure Visit.", - "NCTID": "NCT00100126" - }, - { - "brief_title": "A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease", - "phase": "", - "drugs": "['Western therapy', 'TCM Syndrome Differentiation and Treatment', 'Western therapy plus TCM treatment']", - "drugs_list": [ - "Western therapy", - "TCM Syndrome Differentiation and Treatment", - "Western therapy plus TCM treatment" - ], - "diseases": "['Hand, Foot and Mouth Disease']", - "diseases_list": [ - "Hand", - "Foot and Mouth Disease" - ], - "enrollment": "3000.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of severe hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health; More than 1/3 patients should be diagnosed by etiological examination. \n\n Less than 48 hours of occurrence of fever and/or occurrence of tetter or herpes. \n\n Age of 1-14 years. \n\n Patients or their guardians agree to participate in this study and signed the informed consent form. \n\n ", - "exclusion_criteria": ": \n\n Complicated with other serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, etc. \n\n With history of allergies on traditional Chinese medicine. \n\n Patients or their guardians suffering from Psychiatric diseases. \n\n Attending other clinical studies on HFMD after diagnosed.", - "brief_summary": "The study is aimed to evaluate the effectiveness and safety of traditional Chinese medicine (TCM) for treatment of hand, foot, and mouth disease (HFMD).", - "NCTID": "NCT01182532" - }, - { - "brief_title": "Intravenous Immunoglobulin for PANDAS", - "phase": "Phase 3", - "drugs": "['Gamunex Intravenous Immunoglobulin', 'Placebo']", - "drugs_list": [ - "Gamunex Intravenous Immunoglobulin", - "Placebo" - ], - "diseases": "['Obsessive-Compulsive Disorder', 'Children', 'Anxiety Disorder', 'Autoimmune Disease', 'PANDAS']", - "diseases_list": [ - "Obsessive-Compulsive Disorder", - "Children", - "Anxiety Disorder", - "Autoimmune Disease", - "PANDAS" - ], - "enrollment": "48.0", - "inclusion_criteria": "inclusion criteria: \n\n Male and female children 4-13 years of age. \n\n Presence of (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision) DSM-IV TR OCD with or without a tic disorder. \n\n Moderate or greater severity of symptoms, with a score of greater than or equal to 20 on the Children s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) and greater than or equal to 4 on the Clinical Global Impression Severity scale (CGI-S). \n\n The acute onset within the previous six months of symptoms in a child previously well, or the first acute recurrence within the previous six months, after a period of relatively complete remission of symptoms. The acuity of symptom onset/exacerbation is key and must be severe, dramatic in onset, and proceed from no/minimal symptoms to maximum severity within 24-48 hours. \n\n Symptom onset or first exacerbation preceded within four months by a GAS infection, as documented by positive throat culture, exposure to documented GAS infection (in a close contact, such as a sibling sharing a bedroom), and/or documented two-fold rise in one or more anti-GAS antibody titers such as anti-streptolysin O, anti-streptococcal DNAaseB, anti-carbohydrate antibodies and others. \n\n Onset/exacerbation of OCD is accompanied by at least three of the following 7 clinical signs and symptoms. The acuity of the comorbid symptoms must be similar to the OCD symptoms and occur in the same time interval. \n\n Markedly increased level of anxiety, particularly new onset of separation anxiety. \n\n Emotional lability, irritability, aggressive behavior and/or personality change. \n\n Sudden difficulties with concentration or learning. \n\n Developmental regression (baby-talk, temper tantrums; behaviors atypical for actual chronological age). \n\n Sleep disorder (insomnia, night terrors, refusal to sleep alone). \n\n Handwriting deterioration or other sign of motoric dysfunction (including new onset of motor hyperactivity, or presence of choreiform finger movements). \n\n Urinary frequency or increased urge to urinate; daytime or night-time secondary enuresis. \n\n ", - "exclusion_criteria": ": \n\n History of rheumatic fever, including Sydenham chorea (the neurologic manifestation). \n\n Presence of symptoms consistent with autism, schizophrenia, or other psychotic disorder (unless psychotic symptoms have onset coincident with the possible PANDAS and are attributed to OCD). \n\n Presence of a neurological disorder other than a tic disorder. \n\n IQ <70. Child subjects need to be able to contribute meaningfully to baseline and follow-up ratings, to report adverse effects, and to assent to participation. \n\n Presence of serious or unstable medical illness or psychiatric or behavioral symptoms that would make participation unsafe or study procedures too difficult to tolerate. \n\n IgA deficiency (<20mg/dL). Intravenous immunoglobulin may contain trace IgA, which may very rarely lead to life-threatening anaphylaxis in IgA-deficient participants with anti-IgA antibodies (Misbah 1993). \n\n Hyperviscosity syndromes, which can increase risks associated with IVIG administration. \n\n Need for live virus vaccine within six months after receiving IVIG (which may be 7.5 months from randomization) since IVIG can interfere with effectiveness of such vaccines. IVIG should not be administered sooner than two weeks after administration of a live virus vaccine, for the same reason. \n\n Taking nephrotoxic drugs. Every concomitant medication will be subject to scrutiny and possible consultation with pediatric safety monitors before randomization to study drug. See below as well. \n\n Recent (less than eight weeks) initiation of cognitive-behavior therapy (CBT). \n\n Recent (less than eight weeks) initiation or change in dosage of psychotropic medication for OCD or tic disorder (e.g., serotonin reuptake inhibitors for OCD, alpha-2 agonists or antipsychotics for tic disorders).", - "brief_summary": "Background:~- Some children experience a sudden onset of symptoms similar to those found in obsessive-compulsive disorder that may be caused by the body s reaction to an infection with streptococcal bacteria, most commonly seen as strep throat or scarlet fever. When the body s immune system reacts against brain cells following a streptococcal infection, the condition is known as PANDAS (pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections). The immune system response can be inactivated by treatment with a drug known as intravenous immunoglobulin (IVIG). Because there is insufficient research on IVIG s effects on the immune system of children with PANDAS, including whether IVIG is helpful in treating obsessive-compulsive symptoms related to PANDAS, researchers are interested in examining whether IVIG is an appropriate treatment for PANDAS and its associated symptoms.~Objectives:~- To test the safety and effectiveness of intravenous immunoglobulin for the treatment of obsessive-compulsive disorder in children with PANDAS (pediatric autoimmune neuropsychiatric disorder associated with streptococcal infection).~Eligibility:~- Children between 4 and 12 years of age who have obsessive-compulsive disorder (with or without a tic disorder) with sudden onset of symptoms following Group A streptococcal bacterial infections.~Design:~Participants will be screened by telephone to obtain medical history and other information, followed by in-person screening at the National Institutes of Health Clinical Center.~Participants will be admitted to the hospital to receive 2 days of infusions of either IVIG or a placebo. Frequent blood samples, imaging studies, and other tests will be performed during this visit.~Six weeks after the inpatient stay, participants will return for further blood samples and other tests. Participants who did not receive the study drug, or who received the drug but did not respond to the initial IVIG infusion, will have the option to receive IVIG at this time.~Followup visits will take place 3 months and 6 months after the first evaluation, followed by yearly follow-ups for 5 additional years.", - "NCTID": "NCT01281969" - }, - { - "brief_title": "TELI TON - Telithromycin in Tonsillitis", - "phase": "Phase 3", - "drugs": "['Telithromycin (HMR3647)', 'Penicillin']", - "drugs_list": [ - "Telithromycin (HMR3647)", - "Penicillin" - ], - "diseases": "['Tonsillitis', 'Pharyngitis']", - "diseases_list": [ - "Tonsillitis", - "Pharyngitis" - ], - "enrollment": "314.0", - "inclusion_criteria": "inclusion criteria: \n\n Age 6 months to less than 13 years of age (<13); \n\n Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on: \n\n A positive result from a rapid detection throat swab test for Group A streptococcal antigen and submission of a throat swab specimen for bacterial culture, identification, and antibiotic-susceptibility testing; and \n\n A sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs: \n\n Tonsil and/or pharyngeal erythema and/or exudate; \n\n Cervical adenopathy; \n\n Uvular edema; \n\n Fever \n\n ", - "exclusion_criteria": ": \n\n Symptoms that collectively suggest nonstreptococcal T/P (eg, laryngitis, coryza, conjunctivitis, diarrhea, cough); \n\n History of positive throat culture for Streptococcus pyogenes in the absence of clinical signs and symptoms of T/P; \n\n Infection of the deep tissues of the upper respiratory tract (eg, epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (eg, sinusitis, otitis media, or orbital/periorbital cellulitis); \n\n History of rheumatic heart disease; \n\n Females of childbearing potential (ie, have reached menarche); \n\n Known congenital prolonged QT syndrome; \n\n Known or suspected uncorrected hypokalemia (\u22643 mmol/L [mEq/L]), or hypomagnesemia or bradycardia (<50 bpm); \n\n Myasthenia gravis; \n\n Known impaired renal function, as shown by creatinine clearance \u226425 mL/min \n\n The subject: \n\n Is being treated with drugs not permitted by the study protocol ie, cisapride, pimozide, astemizole, terfenadine, ergotamine, dihydroergotamine, Class IA (eg, quinidine and procainamide) or Class III (eg, dofetilide) antiarrhythmic agents, simvastatin, lovastatin and atorvastatin; \n\n Is currently being treated with systemic antibacterials or has been treated with systemic antibacterials within 14 days prior to enrollment;- Has been treated with any investigational medication within the last 30 days; \n\n Has been treated with rifampicin, phenytoin, carbamazepine, or St. John's wort within the last 2 weeks. \n\n History of hypersensitivity or intolerance to macrolides, penicillins, or cephalosporins; \n\n Previous enrollment in this study or previous treatment with telithromycin; \n\n Children of the investigator or subinvestigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the protocol.", - "brief_summary": "This is a multinational, randomized (1:1), double blind, double dummy, comparator-controlled, 2 parallel treatment group study in subjects from 6 months to < 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P).Each subject will receive either telithromycin 25 mg/kg once daily for 5 days or penicillin V, 13.3 mg/kg three times daily for 10 days. Matching placebo for telithromycin and penicillin V will also be dispensed for 5 and 10 days respectively, to provide blinding to the different treatment regimens. A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.", - "NCTID": "NCT00315042" - }, - { - "brief_title": "An Assessment of Rapid Streptococcal Tests in Community Clinics in Israel", - "phase": "", - "drugs": "['rapid streptococcal testing']", - "drugs_list": [ - "rapid streptococcal testing" - ], - "diseases": "['Pharyngitis', 'Streptococcus Pyogenes Infection', 'Streptococcus Pyogenes Identification']", - "diseases_list": [ - "Pharyngitis", - "Streptococcus Pyogenes Infection", - "Streptococcus Pyogenes Identification" - ], - "enrollment": "7000.0", - "inclusion_criteria": "inclusion criteria: \n\n sore throat \n\n at least two Centor criteria: \n\n fever > 38 deg C or history of fever \n\n enlarged cervical lymph nodes \n\n tonsillar exudate \n\n lack of cough \n\n age 3-14 years \n\n ", - "exclusion_criteria": ": \n\n antibiotic treatment in preceding 7 days \n\n no informed consent", - "brief_summary": "There is a large over-use of antibiotics in family medicine, especially in upper respiratory tract infections.~This study is designed to determine if the use of rapid Streptococcal tests in primary care clinics can lower the rate of antibiotic use while not missing bacterial infections.", - "NCTID": "NCT00535093" - }, - { - "brief_title": "APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat", - "phase": "Phase 3", - "drugs": "['APC-111 MP Tablet, 775 mg']", - "drugs_list": [ - "APC-111 MP Tablet", - "775 mg" - ], - "diseases": "['Sore Throat', 'Pharyngitis', 'Tonsillitis']", - "diseases_list": [ - "Sore Throat", - "Pharyngitis", - "Tonsillitis" - ], - "enrollment": "600.0", - "inclusion_criteria": "inclusion criteria: \n\n Informed consent/assent \n\n Age 12 and older \n\n A clinical diagnosis of acute tonsillitis and/or pharyngitis defined as having the clinical signs and symptoms compatible with tonsillitis and/or pharyngitis, including sore throat and pharyngeal erythema with at least one of the following: \n\n Odynophagia \n\n Tonsillar or pharyngeal exudates \n\n Tender cervical lymph nodes \n\n Fever or history of fever treated with antipyretics \n\n Chills \n\n Uvular edema \n\n Elevated white blood cell count \n\n Red tongue and prominent papillae \n\n A positive rapid screening test for S. pyogenes \n\n Subject is an appropriate candidate for oral antibiotic therapy and can swallow the study dosage forms \n\n Females must be non-lactating and: \n\n At no risk of pregnancy for one of the following reasons: post-menopausal for at least one year, hysterectomy, tubal ligation, or abstinent from sexual activity that could result in pregnancy, OR \n\n If of child-bearing potential and sexually active, the patient must have a negative baseline urine pregnancy test and be utilizing acceptable contraceptives throughout the study. \n\n If of child bearing potential and not currently sexually active, the patient must have a negative baseline urine pregnancy test and must agree to remain abstinent for the duration of the study. If they decide to become sexually active during the period of the study, they must agree to use acceptable contraception. \n\n Are able to comply with the requirements of the protocol \n\n ", - "exclusion_criteria": ": \n\n Chronic or recurrent odynophagia or enlarged tonsils of obscure etiology \n\n More than one episode of acute tonsillitis and/or pharyngitis in the 6 months prior to baseline visit \n\n Pharyngitis known or suspected to be due to a pathogen resistant to \u03b2-lactam antimicrobials \n\n Subjects who are known carriers of S. pyogenes \n\n Previous allergies, serious adverse reaction to, or intolerance to penicillin or any other member of the \u03b2-lactam class of antimicrobials, including cephalosporins \n\n Any serious illness or concomitant condition that the Investigator judges would preclude the study evaluations or make it unlikely that the course of study therapy and follow-up could be completed. This would also include: \n\n Any rapidly progressive underlying disease with a shortened life expectancy \n\n The inability to swallow the study dosage form \n\n Unable to understand the requirements of the study \n\n Neutropenia (<1000 PMNs/mm3) or other immunocompromised state. \n\n Concurrent condition of upper/lower respiratory tract infections \n\n Concurrent symptoms of viral etiology including: \n\n conjunctivitis, coryza, and cough \n\n diffuse adenopathy or rash suggestive of mononucleosis \n\n rash or arthropathy suggestive of scarlet fever \n\n Seizure disorder, lowered seizure threshold, or psychiatric condition requiring use of major tranquilizers \n\n Pregnancy or nursing \n\n Expectation that additional effective systemic antibacterials would be required for any condition during the duration of the study \n\n Current drug or alcohol abuse \n\n Receipt of any experimental drug or medical device within the previous 30 days \n\n Previous treatment under this protocol \n\n The need for hospitalization or I.V. antimicrobial therapy \n\n Previous systemic antimicrobial therapy within 30 days \n\n The presence of clinically significant hematologic conditions \n\n History of cardiovascular disease, renal disease, or neurological disease secondary to previous infection with S. pyogenes or previous rheumatic fever \n\n Probenecid treatment or systemic steroids for 7 days prior to baseline visit and throughout the duration of the study", - "brief_summary": "The primary objective of this study is to evaluate the efficacy of APC 111 MP Tablet, 775 mg tablet, given orally (PO)once daily (QD) for 10 days compared to that of Penicillin VK, 250 mg PO four times daily (QID) for 10 days in terms of bacteriological outcome at the Test-of-Cure (TOC) Visit (Day 14-18) in the eligible Per-Protocol bacteriological (PPb) population.", - "NCTID": "NCT00242281" - }, - { - "brief_title": "Study of ChimeriVax\u2122 Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years", - "phase": "Phase 2", - "drugs": "['CYD Dengue Vaccine Serotypes 1, 2, 3, and 4', 'Pneumococcal polysaccharide vaccine']", - "drugs_list": [ - "CYD Dengue Vaccine Serotypes 1", - "2", - "3", - "and 4", - "Pneumococcal polysaccharide vaccine" - ], - "diseases": "['Dengue Virus', 'Dengue Fever', 'Dengue Hemorrhagic Fever', 'Dengue Diseases']", - "diseases_list": [ - "Dengue Virus", - "Dengue Fever", - "Dengue Hemorrhagic Fever", - "Dengue Diseases" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria : \n\n Aged 2 to 11 years on the day of inclusion. \n\n Participant in good health, based on medical history, physical examination and laboratory parameters. \n\n Provision of Assent Form signed by the participants (for participants >=8 years old) and Informed Consent Form signed by the parents or another legally acceptable representative (and by an independent witness for illiterate parent[s]). \n\n Participant and parents/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures. \n\n For a female participant of child-bearing potential (girls post-menarche), avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination, until at least 4 weeks after the last vaccination. \n\n Documented receipt of yellow fever vaccine since at least one month before the first vaccination. \n\n ", - "exclusion_criteria": " : \n\n Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia. \n\n For a female participant of child-bearing potential (girls post-menarche), known pregnancy. \n\n For a female participant of child-bearing potential (girls post-menarche), known pregnancy or positive pregnancy test in blood sample taken at Screening. \n\n Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination. \n\n Planned participation in another clinical trial during the trial. \n\n Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy. \n\n Known systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances. \n\n Systemic hypersensitivity to YF vaccine or history of a life-threatening reaction to YF vaccine. \n\n Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator. \n\n Current or past alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures. \n\n Receipt of any blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response. \n\n Receipt of any vaccine in the 4 weeks preceding the first trial vaccination. \n\n Planned receipt of any vaccine in the 4 weeks following the first trial vaccination. \n\n Human Immunodeficiency Virus, hepatitis B antigen, or hepatitis C seropositivity in blood sample taken at Screening. \n\n Clinically significant laboratory abnormalities (as determined by the Investigator) in blood sample taken at Screening. \n\n Known previous vaccination with pneumococcal polysaccharide vaccine.", - "brief_summary": "The aim of the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine, against dengue disease.~Primary Objectives:~To describe the humoral immune response to dengue before and after each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years) previously vaccinated with yellow fever (YF) vaccine.~To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years).~To describe viremia after the first and second vaccinations with dengue vaccine in a subgroup of 130 randomized participants (100 participants in Dengue Vaccine Group and 30 participants in Control Group) in two age cohorts of children (6 to 11 years and 2 to 5 years).", - "NCTID": "NCT00788151" - }, - { - "brief_title": "Characterization of Childhood-Onset Obsessive-Compulsive Disorder", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Obsessive-Compulsive Disorder']", - "diseases_list": [ - "Obsessive-Compulsive Disorder" - ], - "enrollment": "49.0", - "inclusion_criteria": "inclusion criteria: \n\n OCD Participants (N = 72) \n\n Aged 4-12 years and living within a four-hour commute from NIH \n\n Currently meet DSM-IV criteria for OCD. \n\n Recent onset of symptoms (less than 6 months.) \n\n Healthy Controls (N = 60-72) \n\n Age and sex matched to ODC participants. \n\n Must be free of current or past psychopathology. \n\n ", - "exclusion_criteria": ": \n\n OCD Participants: \n\n Diagnosis of schizophrenia, schizoaffective, bipolar, delusional, or psychotic disorder; autistic spectrum disorder or pervasive developmental disorder; neurologic disorder other than tics; or rheumatic fever. \n\n Significant or unstable medical illness. \n\n Full scale IQ less than 80. \n\n Healthy Controls: \n\n Full scale IQ less than 80. \n\n Significant or unstable medical illness.", - "brief_summary": "The purpose of this study is to learn more about Obsessive-compulsive Disorder (OCD) in children. OCD usually has a slow onset, and symptoms that may remain at a stable level over time. A subset of children with OCD has a sudden onset and symptoms that fluctuate in severity over time. This study will also compare healthy children to those with OCD. This is an observational study; children who participate will not receive any new or experimental therapies.~OCD affects nearly 1% of the pediatric population. The symptoms of this illness can interrupt development, causing significant psychological distress and producing life-long impairments in social, academic, and occupational functioning. A subgroup of pediatric OCD has been designated by the acronym PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections). This type of OCD is characterized by sudden symptom onset and a relapsing-remitting course of illness; exacerbation of symptoms occurs with scarlet fever or strep. throat infections. This study will identify factors that distinguish children with PANDAS OCD from children with non-PANDAS OCD, and will compare both groups to healthy children.~Children with OCD and their parents are screened with interviews and a review of the child's medical records. Participants have an initial evaluation that includes a psychiatric, physical and neuromotor exam, neuropsychological testing, psychological interviews, and a blood test. Structural magnetic resonance imaging (MRS) scans of the brain are also obtained. The MRS scan does not use radiation.~After the initial evaluation, children with OCD have follow-up visits every 6 weeks for 12 to 24 months. They are seen yearly for 8 years after the study. If they have a significant improvement or worsening of their symptoms, they are asked to make a maximum of two extra visits. Parents of OCD patients are called four times a year to discuss any changes in the child's condition between yearly visits. All participants have a 1-year follow-up visit upon study completion.", - "NCTID": "NCT00044239" - }, - { - "brief_title": "The Use of Functional Confections in Promoting Oral Health", - "phase": "Phase 1", - "drugs": "['Strawberry gummy', 'Placebo control gummy']", - "drugs_list": [ - "Strawberry gummy", - "Placebo control gummy" - ], - "diseases": "['Oral Health', 'Oral Cancer', 'Gum Disease']", - "diseases_list": [ - "Oral Health", - "Oral Cancer", - "Gum Disease" - ], - "enrollment": "36.0", - "inclusion_criteria": "inclusion criteria: \n\n Submit to a 24 hour urine cotinine test which will be used to determine smoking status. \n\n Meet one of the following smoking criteria \n\n Non-smoker \n\n Does not currently smoke or has no history of smoking or using tobacco related products (cigarettes, cigars, pipe, snuff, or chewing tobacco) or smoking any non-tobacco related products and urine cotinine (less than 100 ng/mL \n\n Does not currently smoke but has quit smoking for more than 10 years and smoked less than 1 pack/day of cigarettes when they were actively smoking and has a urine cotinine (less than 100 ng/mL). \n\n Smoker \n\n Smokes habitually at least 10 cigarettes/day and a urine cotinine level of >1000 ng/mL. Cigar and pipe smokers who smoke at least 10 grams of tobacco daily are also eligible. \n\n Agree to consume a standardized vitamin and mineral supplement and avoid other nutritional, dietary, or alternative medications/supplements for the duration of the study. \n\n No history of malabsorptive, gastrointestinal or other metabolic disorders requiring special diet recommendations. \n\n Body mass index (BMI) between 20 and 35 kg/m2 \n\n Abstain from purple and red colored foods and beverages which contain significant anthocyanins and polyphenols \n\n Abstain from the use of ANY mouth washes (commercial or home remedies)during 6 week study period \n\n ", - "exclusion_criteria": " \n\n Have a known allergy to strawberries, corn, and wheat products or those who have never consumed any of these products. \n\n Have active metabolic or digestive illnesses such as malabsorptive disorders (Crohn's, ileus, IBS), renal insufficiency, hepatic insufficiency, hyper- or hypothyroidism, cachexia, morbid obesity, or short bowel syndrome. \n\n Have a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, ACTH, growth hormone, insulin) or other endocrine disorders requiring hormone administration. \n\n Have significant loss of gastrointestinal organs due to surgery, except for appendix. \n\n Have altered immunity such as chronic inflammatory disease, autoimmune disorders, cancer, anemia, hemophilia, and blood dyscrasias. \n\n Heavy alcohol consumers defined as >15 glasses/week (one glass = 1.5 oz. liquor, 5 oz. wine, or 12 oz. beer). \n\n Antibiotic use in the last 6 months or on medications that will accelerate or decrease bowel motility. \n\n Are receiving or in need of dental treatment during the study period. \n\n Have noticeable open lesions, sores that have not healed for more than 3 months, have had any active oral lesions or maladies within the last month, or have a history of leukoplakia, tumors of the buccal cavity, throat, and lips. \n\n Have difficulty swallowing (dysphagia), pain with swallowing (odynophagia), salivary gland dysfunction, or xerostomia (dry mouth). \n\n A non-smoker who is currently or has a history (less than 10 years of smoking abstinence) of either tobacco or non-tobacco related smoking. \n\n Women, who are planning to conceive in the next 6 months, suspect they are pregnant, pregnant, or nursing. \n\n Are taking medications that inhibit clotting (warfarin sodium) or using prescribed oral rinses (Peridex).", - "brief_summary": "In areas of the world where populations are undernourished poor oral health is prevalent. Diets rich in fruit and vegetables are thought to have many health benefits including reducing the risk of oral cancer or gum disease. In particular fruits such as strawberries contain many different compounds which may be responsible for these proposed health benefits.~From this study, the researchers hope to gain information about how the tissues in the mouth absorb strawberry gummies in a population of habitually smoking and never smoking men and women. The researchers will measure inflammation hormones in your saliva and urine and the genes in your mouth and blood. Two different strawberry gummies will be tested in this study. The strawberry gummies were developed at OSU in the Department of Food Science and Technology. One type of strawberry gummy will contain freeze-dried whole strawberries while the other type will have no fruit. In total the eight pieces of strawberry gummies that you will consume in one day will be at most equal to 1 cup of whole strawberries. The research team believes the two strawberry gummies may be digested and absorbed differently and that components in the strawberry gummies may be helpful for oral health.", - "NCTID": "NCT01514552" - }, - { - "brief_title": "TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults", - "phase": "Phase 3", - "drugs": "['Telithromycin', 'Penicillin']", - "drugs_list": [ - "Telithromycin", - "Penicillin" - ], - "diseases": "['Tonsillitis', 'Pharyngitis']", - "diseases_list": [ - "Tonsillitis", - "Pharyngitis" - ], - "enrollment": "233.0", - "inclusion_criteria": "inclusion criteria: \n\n Age equal to or over 13 years; \n\n For female subjects, the following conditions are to be met: \n\n Subject is premenarchal or surgically incapable of bearing children, \n\n Subject is of childbearing potential and all of the following conditions are met: \n\n Have normal menstrual flow within 1 month before study entry, \n\n Have negative pregnancy test (urine pregnancy test sensitive to at least 50 mU/mL, and \n\n Must agree to use an accepted method of contraception throughout the study (if sexually active); \n\n Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on: \n\n A positive result from a rapid detection test for Group A streptococcal antigen and submission of a throat swab specimen for bacterial culture, identification, and antibiotic-susceptibility testing; and \n\n A sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs: \n\n Tonsil and/or pharyngeal erythema and/or exudate; \n\n Cervical adenopathy; \n\n Uvular edema; \n\n Fever \n\n ", - "exclusion_criteria": ": \n\n Symptoms that collectively suggest nonstreptococcal T/P (eg, laryngitis, coryza, conjunctivitis, diarrhea, cough); \n\n History of positive throat culture for Streptococcus pyogenes in the absence of clinical signs and symptoms of T/P; \n\n Infection of the deep tissues of the upper respiratory tract (eg, epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (eg, sinusitis, otitis media, or orbital/periorbital cellulitis); \n\n History of rheumatic heart disease; \n\n Known congenital prolonged QT syndrome; \n\n Known or suspected uncorrected hypokalemia (\u22643 mmol/L [mEq/L) or hypomagnesemia or bradycardia (<50 bpm); \n\n Known impaired renal function, as shown by creatinine clearance \u226425 mL/min \n\n Myasthenia gravis; \n\n History of hypersensitivity or intolerance to macrolides, penicillins, or cephalosporins; \n\n Previous enrollment in this study or previous treatment with telithromycin; \n\n Children of the investigator or subinvestigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the protocol. \n\n Is currently being treated with systemic antibacterials or has been treated with systemic antibacterials within 14 days prior to enrollment; \n\n Has been treated with any investigational medication within the last 30 days; \n\n Has been treated with rifampicin, phenytoin, carbamazepine, or St. John's wort within the last 2 weeks.", - "brief_summary": "This is a multinational, randomized (1:1), double blind, comparator-controlled, 2 parallel treatment group study in subjects equal to or over 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P). Each subject will receive either telithromycin, 400 mg over-encapsulated tablets, 800 mg once daily for 5 days or penicillin V 250 mg over-encapsulated tablets, 500 mg three times daily for 10days. Matching placebo capsules will be dispensed to maintain the blind between the treatment groups.A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.", - "NCTID": "NCT00315549" - } - ], - "1": [], - "2": [ - { - "brief_title": "Multi-center Prospective Randomized Control Trail of High Dose Aspirin in Acute Stage of Kawasaki Disease", - "phase": "", - "drugs": "['Aspirin']", - "drugs_list": [ - "Aspirin" - ], - "diseases": "['Kawasaki Disease']", - "diseases_list": [ - "Kawasaki Disease" - ], - "enrollment": "300.0", - "inclusion_criteria": "inclusion criteria: (both 1 and 2) \n\n 1. All subjects are children who fulfilled the criteria for Kawasaki Disease (American Heart Association criteria). \n\n Fever > 5 days, and 4 of the 5 following symptoms \n\n Diffuse mucosal inflammation (strawberry tongue, dry and fissured lips) \n\n Bilateral non-purulent conjunctivitis, \n\n Dysmorphous skin rashes, \n\n Indurative angioedema over the hands and feet \n\n Cervical lymphadenopathy. (One or more nodule at lease 1.5 cm in diameter) 2. KD patients are treated with IVIG at each hospital after informed contents are obtained. \n\n ", - "exclusion_criteria": ": \n\n Patients whose symptoms did not full fit the Kawasaki Disease criteria. \n\n Had an acute fever for < 5 days and >10 days \n\n Incomplete collection of each followed-up data (CBC/DC, GOT/GPT, BUN/Cr, Albumin, ESR, C-Reactive Protein, 2D echocardiography) \n\n IVIG treatment at other hospital before refers to study centers. \n\n Treatment with corticosteroids, other than inhaled forms, in the previous 2 weeks before enrollment; \n\n The presence of a disease known to mimic Kawasaki disease. \n\n Previous diagnosis of Kawasaki disease \n\n Inability to take aspirin", - "brief_summary": "Kawasaki disease (KD) is an acute multi-system vasculitis syndrome of unknown etiology occurring mostly in infants and children younger than 5 years of age. In developed countries, it is the leading cause of acquired heart disease in children. However, KD remains a mysterious disease.~Single high dose intravenous immunoglobulin (IVIG, 2gm/kg) and aspirin are standard treatment for KD. Aspirin have been prescribed in treatment of KD for decade even earlier than usage of IVIG. High dose aspirin mainly act as anti-inflammation, while low dose aspirin as anti-platelet. IVIG may play most of the role of anti-inflammation in acute stage of KD. Hsieh et al. reported that KD without high dose aspirin had the same treatment response after IVIG. Therefore it is still unclear about the necessarily of high dose aspirin in acute stage of KD.~This study was conduct to investigate the role of high dose aspirin in acute stage of KD via a multi-center randomized control trail, and we plan to achieve the followings till year 2017:~Enroll 300 KD patients from multiple medical centers . Randomize group patients as group 1: with high dose aspirin (more than 30/mg/kd/day) until fever subsided and shift to low dose aspirin (3-5mg/kg/day, N=150); and group 2: without high dose aspirin during acute febrile stage, only use low dose aspirin (N=150).~Compare data including fever days, admission duration, laboratory data (CBC/DC, GOT/GPT, BUN/Cr, Alb, ESR, CRP, 2D echo), IVIG treatment response and CAL formation rate (followed at least 1 year).", - "NCTID": "NCT02359643" - }, - { - "brief_title": "Prevention of Coronary Aneurysms in Kawasaki Syndrome", - "phase": "Phase 2", - "drugs": "['immunoglobulins, intravenous', 'aspirin']", - "drugs_list": [ - "immunoglobulins", - "intravenous", - "aspirin" - ], - "diseases": "['Cardiovascular Diseases', 'Coronary Aneurysm', 'Heart Diseases', 'Mucocutaneous Lymph Node Syndrome']", - "diseases_list": [ - "Cardiovascular Diseases", - "Coronary Aneurysm", - "Heart Diseases", - "Mucocutaneous Lymph Node Syndrome" - ], - "enrollment": "", - "inclusion_criteria": "Boys and girls who met the CDC criteria for Kawasaki Syndrome. Subjects were excluded if they presented themselves to the participating centers after the tenth day of illness.", - "exclusion_criteria": "", - "brief_summary": "To test the efficacy of intravenous gamma globulin (IVGG) in preventing coronary artery aneurysms in children with Kawasaki Syndrome.", - "NCTID": "NCT00000520" - } - ] - }, - { - "patient_id": "sigir-201530", - "patient": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", - "0": [ - { - "brief_title": "A Clinical Trial of Pronation Versus Supination Maneuvers for the Reduction of the Pulled Elbow", - "phase": "", - "drugs": "['Pronation', 'Supination']", - "drugs_list": [ - "Pronation", - "Supination" - ], - "diseases": "['Nursemaid Elbow', 'Pulled Elbow']", - "diseases_list": [ - "Nursemaid Elbow", - "Pulled Elbow" - ], - "enrollment": "90.0", - "inclusion_criteria": "inclusion criteria: \n\n Pulled elbow suspected in any child presenting one of the following: \n\n History of an adult or bigger person that had pulled the child's elbow non-intentionally \n\n Presence of intense pain at the arrival at the emergency department and unwilling to move the arm. \n\n ", - "exclusion_criteria": ": \n\n Any suspect of injury that could be intentional (child abuse) \n\n Any suspicion child of suffering a possible fracture (the mechanism of the injury was not from pulling the child's arm, the arm presents obvious deformity, ecchymoses, edema, etc.) \n\n The mechanism was from multiple trauma \n\n Any chronic disease affecting the adequate bone mineralization (vitamin D deficiency, osteogenesis, etc.)", - "brief_summary": "Nursemaid elbow or pulled elbow is a condition commonly seen in the emergency department. It is the sudden pull of the radial head (a bone in the elbow) in toddlers. Usually occur when a parent tries to pull the child by the arm and a clic or clunk is felt with immediate pain and unwilling to move the arm. It is not a dangerous condition although it is distressing for kids and their parents/caretakers.", - "NCTID": "NCT01562535" - }, - { - "brief_title": "Immobilization in External Rotation After First Time Anterior Shoulder Dislocation", - "phase": "", - "drugs": "['External rotation shoulder sling', 'Internal rotation shoulder sling']", - "drugs_list": [ - "External rotation shoulder sling", - "Internal rotation shoulder sling" - ], - "diseases": "['Shoulder Dislocation']", - "diseases_list": [ - "Shoulder Dislocation" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n 14 to 30 years of age \n\n Willing to participate in follow-up for at least two years \n\n Acute, first-time, traumatic, isolated anterior dislocation of the shoulder \n\n ", - "exclusion_criteria": ": \n\n Previous instability of the affected shoulder \n\n A history of significant ligamentous laxity or demonstrated multi-directional instability of the opposite shoulder \n\n Inability or unwillingness to comply with sling immobilization, rehabilitative protocol, or required follow-up assessments \n\n Incompetent or unwilling to consent \n\n A medical condition making the patient unable to wear a sling \n\n Significant associated fracture (Exception Hill Sachs of >20% or bony Bankart lesions>10%) \n\n Neurovascular compromise of the affected limb \n\n Concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program.", - "brief_summary": "Comparison of immobilization in internal versus external rotation after first time anterior shoulder dislocation.", - "NCTID": "NCT00707018" - }, - { - "brief_title": "Acromio-clavicular Dislocation Type III - Conservative Treatment Versus Surgical Hook Plate Treatment", - "phase": "", - "drugs": "['Conservative treatment - brace', 'Hook plate by Synthes']", - "drugs_list": [ - "Conservative treatment - brace", - "Hook plate by Synthes" - ], - "diseases": "['Acromio-clavicular Joint Dislocation (Type III)']", - "diseases_list": [ - "Acromio-clavicular Joint Dislocation (Type III)" - ], - "enrollment": "56.0", - "inclusion_criteria": "inclusion criteria: \n\n men or women \u2265 18 years-old; \n\n AC joint dislocation type III with Zanca X-ray view demonstrating CC distance of 200%; \n\n trauma-surgery delay of less than 14 days; \n\n consent form signed. \n\n ", - "exclusion_criteria": ": \n\n AC joint dislocation type I, II, IV, V or VI; \n\n associated neuro-vascular damage; \n\n men or women > 60 years-old; \n\n open dislocation; \n\n local skin damage; \n\n dislocation in a polytrauma patient; \n\n floating shoulder; \n\n fracture of the ipsilateral or controlateral arm or shoulder girdle; \n\n fracture of the coracoid process of the scapula; \n\n history of previous surgery to the shoulder; \n\n medical condition preventing surgery; \n\n men or women unfit to consent; \n\n any other condition that make the examinator thinks that the follow up would be problematic.", - "brief_summary": "Acromio-clavicular (AC) joint dislocation corresponds to 8.6% of all joint dislocations and represents a major injury to the shoulder girdle. The nature of the treatment is decided according to the severity of the lesion.~The purpose of this study is to determine whether the surgical treatment is required or not for type III AC joint dislocations.", - "NCTID": "NCT01110304" - }, - { - "brief_title": "Naproxen for the Prevention of HO After Complex Elbow Trauma", - "phase": "Phase 4", - "drugs": "['Naproxen']", - "drugs_list": [ - "Naproxen" - ], - "diseases": "['Heterotopic Ossification']", - "diseases_list": [ - "Heterotopic Ossification" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Subjects aged 18 years or greater \n\n Operative treatment of one of the following injuries \n\n An elbow dislocation with or without associated fractures \n\n An olecranon fracture-dislocation, but not simple olecranon fractures \n\n A distal humerus fracture \n\n ", - "exclusion_criteria": ": \n\n An existing diagnosis of one of the following conditions \n\n Injury to the central nervous system, thorax, or abdomen precluding the immediate use of non-steroidal anti-inflammatory medications \n\n Fracture of any long bone since non-steroidal anti-inflammatory medications may increase the risk of nonunion \n\n History of gastritis, peptic ulcer disease, or upper gastrointestinal bleeding \n\n Impaired renal function (creatinine > 2.0), hypovolemia, heart failure, high blood pressure ( > 160/90), fluid retention, asthma, liver dysfunction (bilirubin > 2.0), or a coagulation disorder \n\n Allergy to non-steroidal anti-inflammatory medications \n\n Asthma, nasal polyps, urticaria, and hypotension associated with the use of NSAIDs \n\n Considerable dehydration \n\n Pregnant or breast-feeding women \n\n Concomitant use of one of the following drugs: \n\n Aspirin \n\n Other naproxen products (ec-naprosyn, anaprox, anaprox ds, naprosyn suspension, aleve) \n\n Methotrexate \n\n Diuretics (thiazides / furosemide) \n\n ACE-inhibitors (captopril, enalapril, ramipril etc.) \n\n Beta-blockers (propanolol etc.) \n\n Probenecid (for gout or hyperuricemia) \n\n H2-blockers, sucralfate and intensive antacid therapy \n\n Lithium \n\n Anticoagulants / Warfarin (coumadin, waran, jantoven etc.) \n\n Sulfonamides \n\n Anticonvulsant medication (peganone, mesantoin, cerebyx, dilantin, etc.)", - "brief_summary": "Complex elbow fractures can lead to formation of new bone (called Heterotopic ossification). This new bone is unwanted and it can restrict motion. This research study is being done to learn more about the effect of the drug naproxen, on unwanted formation of new bone around the elbow as it heals after a fracture. Naproxen belongs to a class of drugs called NSAIDs which stands for non-steroidal anti-inflammatory drugs.~Several research studies suggest that NSAIDs such as Naproxen can prevent the unwanted formation of new bone around the hip. The effect of NSAIDS on the formation of bone around the elbow has not been studied as well as it has been studied for their effect on the hip.~The drug, Naproxen is approved by the US food and drug administration (FDA) for sale but ot specifically for the treatment of heterotopic ossification.", - "NCTID": "NCT00586365" - }, - { - "brief_title": "A Prospective, Randomized Study of Operative and Nonoperative Treatment for Primary Traumatic Patellar Dislocation", - "phase": "", - "drugs": "['proximal patellar surgery', 'Nonoperative']", - "drugs_list": [ - "proximal patellar surgery", - "Nonoperative" - ], - "diseases": "['Patellar Dislocation']", - "diseases_list": [ - "Patellar Dislocation" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n An acute primary traumatic patellar dislocation \n\n ", - "exclusion_criteria": ": \n\n Previous dislocation or subluxation of the patella \n\n Pre-existing ipsilateral or contralateral knee pathology \n\n Previous knee trauma or patellar fracture.", - "brief_summary": "The objective of this prospective, randomized cohort study was to evaluate the clinical results between operative and nonoperative treatment of primary patellar dislocation.", - "NCTID": "NCT00551668" - }, - { - "brief_title": "Wrist Extension Dynasplint (WED) Distal Radius Fracture", - "phase": "", - "drugs": "['Wrist Extension Dynasplint']", - "drugs_list": [ - "Wrist Extension Dynasplint" - ], - "diseases": "['Distal Radius Fracture', 'Wrist Contracture']", - "diseases_list": [ - "Distal Radius Fracture", - "Wrist Contracture" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Distal radius fracture treated with surgical management and wrist flexion contracture upon follow up \n\n ", - "exclusion_criteria": ": \n\n Carpal Fractures (Scaphoid, Lunate, Hamate, and Trapezium) \n\n Radial nerve entrapment \n\n Arthrodesis \n\n Traumatic dislocation of the distal ulna", - "brief_summary": "The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for wrist extension contracture following a distal radius fracture.", - "NCTID": "NCT01589627" - }, - { - "brief_title": "Dynasplint for Distal Radius Fracture", - "phase": "", - "drugs": "['Wrist Extension Dynasplint']", - "drugs_list": [ - "Wrist Extension Dynasplint" - ], - "diseases": "['Distal Radius Fracture']", - "diseases_list": [ - "Distal Radius Fracture" - ], - "enrollment": "50.0", - "inclusion_criteria": "inclusion criteria: \n\n Distal radius fracture treated with surgical management and wrist flexion contracture upon follow up \n\n ", - "exclusion_criteria": ": \n\n Carpal Fractures (Scaphoid, Lunate, Hamate, and Trapezium) \n\n Radial nerve entrapment \n\n Arthrodesis \n\n Traumatic dislocation of the distal ulna", - "brief_summary": "The purpose of this study was to examine the efficacy of dynamic splinting as a therapeutic modality in reducing contracture following surgical treatment of distal radius fractures.", - "NCTID": "NCT01032356" - }, - { - "brief_title": "Late Compared to Early Physiotherapy Following Knee Dislocation", - "phase": "", - "drugs": "['Early Physiotherapy start']", - "drugs_list": [ - "Early Physiotherapy start" - ], - "diseases": "['Traumatic Knee Dislocation']", - "diseases_list": [ - "Traumatic Knee Dislocation" - ], - "enrollment": "38.0", - "inclusion_criteria": "inclusion criteria: \n\n Ambulation without aids in pre-morbid condition \n\n Multi-ligament knee injury with or without associated peri-articular fracture \n\n Operative management within three weeks of the injury \n\n ", - "exclusion_criteria": ": \n\n Poly-trauma with life-threatening injuries preventing rehabilitation \n\n Patients unable to comply with intensive rehabilitation \n\n Patients unable or unlikely to maintain follow-up", - "brief_summary": "A knee dislocation is an unusual and extremely serious injury and is defined as complete displacement of the tibia with respect to the femur, usually with disruption of 3 or more of the stabilizing ligaments. When the knee dislocates, there is often significant damage to the soft-tissues envelope surrounding the joint, including adjacent neurovascular structures. Not surprisingly, this injury is a profoundly debilitating, life-altering event, with the potential to necessitate career change in athletes and laborers alike. Current evidence indicates that operative management for these injuries is more effective at returning patients to pre-morbid range of motion (ROM) and activity than conservative management. Post operative rehabilitation programs for these patients must balance the need for stability of their surgical repair and knee ROM and functionality. Experimental data suggests that post-operative immobilization offers greater protection of the surgical reconstruction, whereas immediate, aggressive physiotherapy may be more effective at preventing arthrofibrosis stiffness. The investigators are proposing a randomized clinical trial comparing early physiotherapy (day one post op) versus immobilization for three weeks then initiation of physiotherapy. The physiotherapy progams will be identicalbe in all aspects except for progam initiation.", - "NCTID": "NCT01296750" - }, - { - "brief_title": "Arthroscopic Versus Open Stabilization for Traumatic Shoulder Instability", - "phase": "", - "drugs": "['Open stabilization', 'Arthroscopic stabilization']", - "drugs_list": [ - "Open stabilization", - "Arthroscopic stabilization" - ], - "diseases": "['Joint Instability', 'Shoulder Dislocation']", - "diseases_list": [ - "Joint Instability", - "Shoulder Dislocation" - ], - "enrollment": "194.0", - "inclusion_criteria": "inclusion criteria: \n\n Clinical: \n\n Age 14 years or greater \n\n Diagnosis of traumatic anterior shoulder instability, made by meeting all of the following: \n\n Radiographic evidence or documented physician assisted reduction of anterior shoulder dislocation following a traumatic injury. \n\n Ability to elicit unwanted glenohumeral translation which reproduce symptoms with one of the following tests: anterior apprehension, relocation test, or anterior load and shift test \n\n Radiological: \n\n Closed growth plate on a standardized series of x-rays consisting of a minimum of an anteroposterior view, lateral in the scapular plane and an axillary view. \n\n ", - "exclusion_criteria": ": \n\n Clinical: \n\n Diagnosis of multidirectional instability (MDI) or multidirectional laxity with anteroinferior instability (MDL-AII), made by two or more of: \n\n Symptomatic (pain or discomfort) in inferior or posterior direction \n\n Ability to elicit unwanted posterior glenohumeral translation that reproduces symptoms with posterior apprehension tests, or posterior load and shift test \n\n Positive sulcus sign of 1cm or greater that reproduces patient's clinical symptoms \n\n Previous surgery on the affected shoulder other than diagnostic arthroscopy \n\n Cases involving litigation \n\n Significant tenderness of acromioclavicular/sternoclavicular joints on affected side \n\n Confirmed connective tissue disorder (ie: Ehlers-Danlos, Marfan)", - "brief_summary": "The purpose of this study is to compare arthroscopic and open shoulder stabilization procedures by measuring the disease-specific quality of life outcome in patients with traumatic unidirectional anterior instability of the shoulder at 2 and 5 years.~Hypothesis: There is no difference in disease-specific quality of life outcomes in patients with traumatic unidirectional anterior shoulder instability, undergoing an arthroscopic versus an open stabilization procedure.", - "NCTID": "NCT00251264" - }, - { - "brief_title": "Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster", - "phase": "", - "drugs": "['Volar plate', 'Synthes TCP volar plate']", - "drugs_list": [ - "Volar plate", - "Synthes TCP volar plate" - ], - "diseases": "['Distal Radius Fracture']", - "diseases_list": [ - "Distal Radius Fracture" - ], - "enrollment": "130.0", - "inclusion_criteria": "inclusion criteria: \n\n Dorsally displaced, 20 degrees or from a plane perpendicular do the diaphyseal axis, fracture. \n\n Low energy injury \n\n Patient 70 years old or older \n\n 72 hours or less since injury at time of diagnosis \n\n Patient registered in the Stockholm region \n\n Patient understands spoken and written swedish \n\n ", - "exclusion_criteria": ": \n\n Intraarticular displacement in radiocarpal joint of more than 1 mm \n\n Ulna fractured proximal to the base of the styloid process of ulna \n\n Earlier unilateral functional impairment of hand/wrist \n\n Injury to tendon, nerve or skin besides the fracture \n\n Rheumatoid arthritis or other severe systemic joint disease \n\n Severe psychiatric disorder, ongoing drug abuse or dementia (Pfeiffer score 5 points or less) \n\n Besides the wrist fracture also other big injuries, for example fracture of hip, shoulder or ankle \n\n Medical illness that makes general anesthesia impossible", - "brief_summary": "Distal radius fractures with dorsal dislocation among patients 70 years or older are randomized to conservative treatment with plaster or internal fixation with a volar plate. Thereafter they are followed at 2 weeks, 5 weeks, 3 months and 12 months with x-ray, functional scores and clinical examination.~An additional follow up at three years with X-ray, functional scores and clinical outcome will be conducted after a new written consent of continued participation in the study.~A health economy analysis will be preformed at 1, and 3 years for the participants with complete EQ5D.", - "NCTID": "NCT02154620" - }, - { - "brief_title": "Freehand Ultrasound to Evaluate Scapular Kinematics in People With Paraplegia", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Spinal Cord Injuries', 'Shoulder Impingement Syndrome']", - "diseases_list": [ - "Spinal Cord Injuries", - "Shoulder Impingement Syndrome" - ], - "enrollment": "40.0", - "inclusion_criteria": "inclusion criteria: \n\n Above 18 years old \n\n Have paraplegia as a result of a spinal cord injury morn than one year; \n\n Able to perform push-ups independently and raise the arm above the head; \n\n Self-propel a manual wheelchair as the primary means of mobility \n\n ", - "exclusion_criteria": ": \n\n Have history of fractures or dislocations in the shoulder, elbow, or wrist from which you have not fully recovered; \n\n Have upper limb pain as a result of a complex regional pain syndrome; \n\n Have a implant or pacemaker within the torso or upper arm; \n\n Pregnant female.", - "brief_summary": "Shoulder pain is very common in people with spinal cord injury (SCI). Persons with high-level paraplegia have higher chances to suffer shoulder pain and injury than those with lower-level paraplegia due to the shoulder muscle imbalance. As people with SCI overuse the shoulder during routine daily activities, the onset of pain or injury lead to increased healthcare expenses, limitation in activity, depression, decreased participation, and reduced quality of life. One of the main reasons of shoulder pain is believed to have a altered scapular movement. To clarify the mechanism of the shoulder pain and injury, comprehensive understanding of three-dimensional scapular kinematics is required. Ultrasound is a low-cost and non-invasive imaging system and has been used to diagnose the shoulder pain and injury in individuals with SCI. A freehand ultrasound (FUS) combining ultrasound with motion capture system to evaluate scapular movement was developed and presented favorable results in able-bodied population. The purpose of this study is to compare the FUS and widely used skin-based method against a radiographic based gold standard in people with paraplegia, and to elucidate the relationship among scapular movement and shoulder pain, pathology. This study will also allow us to gain more understanding of how level of injury influences the scapular behavior during functional activities. The investigators believe more severe shoulder pain and pathology will be associated with greater abnormal scapular movement. The investigators also believe that people with high-level paraplegia will have greater scapular abnormality than people with low-level paraplegia during arm elevation and weight relief raise tasks. By completing this study, the investigators will expect to deliver a reliable and valid tool to evaluate scapular movement and gain a better understanding how the altered scapular movement is related to shoulder pain and pathology. The investigators will also learn how the level of injury affects the scapular behavior during functional activities. The results of this study may help the shoulder pain management leading to the improvement in the quality of life of individuals with SCI.", - "NCTID": "NCT02357914" - }, - { - "brief_title": "Posterior Compression Distraction Reduction \uff08CDR\uff09Technique in the Treatment of BI-AAD", - "phase": "Phase 3", - "drugs": "['Posterior Approach Compression Distraction Reduction']", - "drugs_list": [ - "Posterior Approach Compression Distraction Reduction" - ], - "diseases": "['Basilar Invagination Associated With Atlantoaxial Dislocation']", - "diseases_list": [ - "Basilar Invagination Associated With Atlantoaxial Dislocation" - ], - "enrollment": "22.0", - "inclusion_criteria": "inclusion criteria: \n\n Age between 18-70 \n\n Patients with cervical CT display that atlanto occipital fusion or partial fusion, Atlantoodontoid interval(ADI)>>3mm, odontoid tip over Qian line(CL)>>3mm. \n\n Agreed to the surgical operation treatment \n\n The patient can carry out clinical follow-up and agree to long-term clinical follow-up \n\n Signed informed consent \n\n ", - "exclusion_criteria": ": \n\n Patients with traumatic atlanto-axial dislocation \n\n Patients with rheumatoid atlantoaxial dislocation \n\n Patients with a history of occipital cervical junction operation \n\n Patients with severe cerebellar tonsillar hernia (reach the C2 margin), needed to remove tonsil of cerebellum \n\n Patients during pregnancy and the postpartum period within 3 months \n\n The life expectancy of < 1 years \n\n Severe dementia(MMSE<18) \n\n Severe renal failure (CR > 2.5mg/dl) \n\n Serious cardiovascular disease (such as unstable angina, heart failure) \n\n Atrial fibrillation and other severe arrhythmia \n\n Without the ability to sign the informed consent", - "brief_summary": "Posterior compression - distraction reduction technique \uff08CDR\uff09 in the treatment of Basilar invagination associated with atlantoaxial dislocation", - "NCTID": "NCT02463630" - }, - { - "brief_title": "ExploR\u00ae Modular Radial Head Data Collection", - "phase": "", - "drugs": "['ExploR\u00ae Modular Radial Head']", - "drugs_list": [ - "ExploR\u00ae Modular Radial Head" - ], - "diseases": "['Degenerative Conditions of the Radial Head/Neck', 'Post-traumatic Conditions of the Radial Head/Neck']", - "diseases_list": [ - "Degenerative Conditions of the Radial Head/Neck", - "Post-traumatic Conditions of the Radial Head/Neck" - ], - "enrollment": "4.0", - "inclusion_criteria": "inclusion criteria: \n\n The inclusion criteria will be the same as the indications stated in the FDA cleared (510(k) K040611) and (510(k) K051385) labeling for the device. \n\n Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: \n\n Joint destruction and/or subluxation visible on x-ray \n\n Resistance to conservative treatment \n\n Primary replacement after fracture of the radial head \n\n Symptomatic sequelae after radial head resection \n\n Revision following failed radial head arthroplasty \n\n The device is intended for single use with or without bone cement. \n\n Modular Radial Head replacement prostheses have received FDA clearance for cemented and non-cemented application. \n\n Patient selection factors to be considered include: 1) need to obtain pain relief and improve function, 2) ability and willingness of the patient to follow instructions, including control of weight and activity levels, 3) a good nutritional state of the patient, and 4) the patient must have reached full skeletal maturity. \n\n ", - "exclusion_criteria": ": \n\n The ", - "brief_summary": "The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the ExploR\u00ae Modular Radial Head. This data collection effort will document the clinical outcomes of the radial head.", - "NCTID": "NCT00533234" - }, - { - "brief_title": "Circumferential Lesions of the Glenoid Labrum", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Shoulder Instability']", - "diseases_list": [ - "Shoulder Instability" - ], - "enrollment": "39.0", - "inclusion_criteria": "inclusion criteria: \n\n Surgical documentation of Pan Labral Lesion of shoulder \n\n Pre-operative documentation of outcomes scores \n\n ", - "exclusion_criteria": ": \n\n lacking a Pan labral lesion \n\n other confounding pathology such as nerve deficit, chondral damage, rotator cuff tear", - "brief_summary": "Objective: Symptomatic pan-labral or circumferential (360 degree) tears of the glenohumeral labrum are an uncommon injury. The purpose of this study is to report the prospective surgical results of circumferential lesions of the glenoid labrum using validated outcome instruments.~Methods: From July 2003 to May 2006, 41 shoulders in 39 patients with mean age of 25.1 years (range, 17 to 38) were prospectively enrolled in a multi-center study (3 surgeons) and treated for a circumferential (360-degree) lesion of the glenoid labrum. There were 34 men and 5 women, all with a primary diagnosis of pain and recurrent shoulder instability. All patients underwent arthroscopic repair of the circumferential labral tear with a mean of 7.1 suture anchors (range, 6 to 9). The outcomes in 39 of 41 shoulders (92.7% follow-up) were assessed at a mean final follow-up of 31.8 months (range, 24 to 53 months) with VAS pain and instability scales (0 to 10), a physical examination, the Single Assessment Numeric Evaluation Score (SANE), the American Shoulder and Elbow Surgeons Score (ASES), and the SF-12 score.", - "NCTID": "NCT00849927" - }, - { - "brief_title": "Treatment of Distal Radius Buckle Fractures", - "phase": "", - "drugs": "['Supportive Care', 'Cast']", - "drugs_list": [ - "Supportive Care", - "Cast" - ], - "diseases": "['Fracture Treatment']", - "diseases_list": [ - "Fracture Treatment" - ], - "enrollment": "11.0", - "inclusion_criteria": "inclusion criteria: \n\n Children age 1-17 with buckle fractures of the distal radius and/or ulna. - \n\n ", - "exclusion_criteria": ": \n\n Patients are excluded if there is any other injury to the upper limb or serious bodily trauma that might complicate pain scores. Children with suspected or proven metabolic bone disease, or pathologic fractures are excluded due to resultant abnormal bone healing.", - "brief_summary": "This study determines if patients with buckle fractures of the distal radius and/or ulna treated with supportive care only demonstrate non-inferior outcomes in regard to pain control during healing, functional outcome at the wrist joint, and parental satisfaction, when compared with patients treated with the standard treatment regimen of 3-4 weeks in a short arm cast.", - "NCTID": "NCT01762605" - }, - { - "brief_title": "Clinical and Ultrasonographic Results of Intratissue Percutaneous Electrolysis in Lateral Epicondylitis", - "phase": "", - "drugs": "['Intratissue percutaneous electrolysis, associated with eccentric exercise and stretching']", - "drugs_list": [ - "Intratissue percutaneous electrolysis", - "associated with eccentric exercise and stretching" - ], - "diseases": "['Lateral Epicondylitis']", - "diseases_list": [ - "Lateral Epicondylitis" - ], - "enrollment": "36.0", - "inclusion_criteria": "Individuals who meet all of the following criteria are eligible for enrollment into the study: \n\n inclusion criteria: \n\n Adult between 18-45 years of age \n\n Pain over the lateral humeral epicondyle provoked by at least two of the following: gripping, palpation, stretching of forearm extensor muscles and resisted wrist or middle finger extension \n\n Persistent pain for at least 3 months despite conservative treatments including medication (oral nonsteroidal antiinflammatory drugs (NSAIDs) and analgesics), brace application, or physiotherapy \n\n Patients with structural tendon changes at the origin of the extensors, demonstrated during musculoskeletal ultrasound \n\n Individuals who meet any of the following criteria are disqualified from enrollment of the study: \n\n ", - "exclusion_criteria": ": \n\n Patients with a history of advanced cervical arthrosis in the C4-C6 segments. \n\n Bilateral LE with central sensitization \n\n Symptoms compatible with posterior interosseous nerve entrapment. \n\n Previous surgery, fractures, trauma or previous history of rheumatic disorders in the area of the lateral epicondyle \n\n History of corticosteroid injection at the lateral epicondyle within the last 3 months \n\n Two experienced professionals performed recruitment and examination of subjects in order to assess for eligibility criteria. All eligible patients provided written informed consent.", - "brief_summary": "Lateral epicondylitis (LE) is the most common cause of lateral elbow pain. Intratissue percutaneous electrolysis (EPI technique) is a novel minimally invasive approach which consists in the application of a galvanic current through a puncture needle which produces a local inflammatory process in the soft tissue and the reparation of the affected tissue.~The purpose of this study is to evaluate the clinical and ultrasonographic effectiveness of a multimodal program using the intratissue percutaneous electrolysis technique and exercises in the short term for patients with chronic lateral epicondylitis, and to determine whether the clinical outcomes achieved decline over time.~This study is an observational one-way repeated measures design. 36 patients in a clinical setting presenting with lateral epicondylitis (mean age = 38, mean time since injury = 12.6 months) received one session of EPI per week over 4-6 weeks, associated with a home program of eccentric exercise and stretching. The main outcome measures were severity of pain (VAS, digital algometer, Cozen and Thompson tests), disability (DASH questionnaire), structural tendon changes (ultrasound), hypervascularity (power doppler) and patient's perceptions of overall outcome (4-point scale). Measurements at 6, 26 and 52 weeks follow-up included recurrence rates (increase of severity of pain or disability compared to discharge), the perception of overall outcome and success rates. Paired Student t-tests and Chi squared tests were applied to data. Enrollment into this study ended in September 2012.~All outcome measures registered significant improvements between pre-intervention and discharge. Most patients (30, i.e. 83.3%) rated overall outcome as 'successful' at 6 weeks. The ultrasonographic finding revealed that the hypoechoic regions and hypervascularity of the extensor carpi radialis brevis change significantly. At 26 and 52 weeks, all participants (32) perceived a 'successful' outcome. Recurrence rates were null after discharge, and at the 6, 26 and 52 week follow-ups.", - "NCTID": "NCT02085928" - }, - { - "brief_title": "Cerebral Palsy Hip Health Related Quality of Life", - "phase": "", - "drugs": "['Cerebral palsy, post hip surgery']", - "drugs_list": [ - "Cerebral palsy", - "post hip surgery" - ], - "diseases": "['Cerebral Palsy', 'Patient Undergoing Hip Surgery', 'Quality of Life']", - "diseases_list": [ - "Cerebral Palsy", - "Patient Undergoing Hip Surgery", - "Quality of Life" - ], - "enrollment": "31.0", - "inclusion_criteria": "inclusion criteria: \n\n Ages 4-18 \n\n Undergoing surgical treatment for hip subluxation or dislocation \n\n Diagnosis of cerebral palsy or similar condition causing motor impairment \n\n Consent to participate \n\n ", - "exclusion_criteria": ": \n\n Diagnosis of neuromuscular disorders other than cerebral palsy \n\n younger than 4, older than 18 \n\n Reimer's migration percentage <40%", - "brief_summary": "Children with cerebral palsy are at an increased risk of having their hips move partially or completely out of joint. This can cause pain and restrict movement at the hip, making sitting in a wheelchair uncomfortable and make personal care difficult. This condition may be treated with surgery. Surgeons use x-rays taken before and after the surgery to determine whether or not the surgery has been successful. However, it is also important to know whether the surgery has improved life from the child or the caregiver's point of view. The investigators will also evaluate if waiting for surgery affects the child. This information will be added to results from a physical exam and an evaluation of the child's x-rays for a more complete picture of how this surgery impacts the lives of our patients. It is predicted that that the health-related quality of life of children with cerebral palsy will improve following surgery.", - "NCTID": "NCT01773161" - }, - { - "brief_title": "Fracture of Distal Radius and Ulna Healed With Shortening of One Bone. Clinical Significance at Skeletal Maturity", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Forearm Injuries']", - "diseases_list": [ - "Forearm Injuries" - ], - "enrollment": "20.0", - "inclusion_criteria": "inclusion criteria: \n\n Children that had had Ulna or Radius X-rays \n\n Signing Informed consent. \n\n ", - "exclusion_criteria": ": \n\n - Unwillingness to sign informed consent.", - "brief_summary": "The fractures of distal forearm are the most common trauma in children. Sometimes one of the bones becomes shortened as a result of fracture fragments overlap. When some amount of shortening exists, concern regarding relationship of distal radio-ulnar joint (DRUJ) arises. The common opinion is expressed in one of the textbooks and is represented by one sentence, which usually one bone shortening is well tolerated, probably does not cause a problem, and does not have clinical significance. However, pathology of ulna plus or minus variants is well described and may cause ulno-carpal abutting syndrome or radiocarpal pain. This concern may lead to more aggressive approach in treatment of a fracture, with attempts to make an equal bone length. We did not find in the literature study that investigates this problem. We postulate that obvious shortening of one bone may cause an inequality of DRUJ and can be clinically significant.", - "NCTID": "NCT00492154" - }, - { - "brief_title": "Duration of Immobilization After Rotator Cuff Repair: Its Clinical Impact", - "phase": "", - "drugs": "['Immobilization']", - "drugs_list": [ - "Immobilization" - ], - "diseases": "['Rotator Cuff Tear']", - "diseases_list": [ - "Rotator Cuff Tear" - ], - "enrollment": "100.0", - "inclusion_criteria": "inclusion criteria: \n\n Medium to large sized cuff tear (2-4 cm) \n\n Yes subscapular partial fraying or longitudinal split side to side \n\n Yes acromioplasty \n\n Yes AC arthritis with mumford procedure \n\n Yes biceps tenotomy or tenodesis \n\n ", - "exclusion_criteria": ": \n\n No arthritic changes of glenohumeral joint \n\n No combined infection \n\n No mini-open procedures \n\n No complete subscapularis tear \n\n No incomplete repair \n\n No small tears or side to side repairs without anchors \n\n No pregnancy", - "brief_summary": "The purpose of this study is to determine whether the immobilization period is helpful for the better healing of repaired rotator cuff.~The investigators hypothesis is that the longer immobilization after rotator cuff repair will help the healing of rotator cuff.", - "NCTID": "NCT00891566" - }, - { - "brief_title": "Sexual Function Questionnaire Total Hip Replacement", - "phase": "", - "drugs": "['Prospective - Factors affecting sexual function pre-THR', 'Retrospective- Factors affecting sexual function post-THR']", - "drugs_list": [ - "Prospective - Factors affecting sexual function pre-THR", - "Retrospective- Factors affecting sexual function post-THR" - ], - "diseases": "['Arthritis']", - "diseases_list": [ - "Arthritis" - ], - "enrollment": "0.0", - "inclusion_criteria": "inclusion criteria: \n\n Female \n\n Sexually active \n\n Heterosexual \n\n 18- 65 years undergoing THR (prospective) or having undergone THR surgery within the last year \n\n ", - "exclusion_criteria": ": \n\n Sexually inactive pre-operatively and wishing to remain sexually inactive post-operatively \n\n Unable to comprehend English and with capacity to consent and follow instruction \n\n Unable to sign and date the ethics committee approved consent documentation", - "brief_summary": "Non-commercial trial~2 Centres involved: University Hospital Southampton and Spire Southampton~Expected number of eligible participants available per year: 100, (95% expected to agree to participation)~The study will recruit prospectively female patients aged 18 - 65 years undergoing THR. A retrospective series of similar patients who have had a hip replacement will also be recruited.~This is a research project that will run over 2 years. Data from 200 patients will be collected and analysed:~Retrospective 30 question questionnaire: 'Arthroplasty & Sexual Function Questionnaire (ASFQ) - Post-operative' Version 1.3 11/07/14~Prospective 23 question questionnaire: 'Arthroplasty & Sexual Function Questionnaire (ASFQ) - Pre-operative' Version 1.3 11/07/14~This project is significant in exploring an area of Orthopaedic medicine that has been little discussed in the literature. Preliminary results of our questionnaires have already revealed patients have a great desire to know how hip replacement will affect sexual function. Components of the questionnaire look at details such as: reasonable time frames for returning to sexual activity, positions that may be undesirable following replacement and which may lead to dislocation, concurrent use of analgesia and psychosexual aspects of total hip replacement surgery. The ultimate objective is to provide patients with detailed information about what to expect after hip replacement surgery.", - "NCTID": "NCT02290652" - }, - { - "brief_title": "Effectiveness of Minimally Invasive Total Knee Replacement in Improving Rehabilitation and Function", - "phase": "Phase 2", - "drugs": "['Minimally Invasive Total Knee Arthroplasty [TKA Min]', 'Total Knee Arthroplasty (TKA) Traditional']", - "drugs_list": [ - "Minimally Invasive Total Knee Arthroplasty [TKA Min]", - "Total Knee Arthroplasty (TKA) Traditional" - ], - "diseases": "['Osteoarthritis']", - "diseases_list": [ - "Osteoarthritis" - ], - "enrollment": "44.0", - "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of osteoarthritis \n\n Eligible for a unilateral or bilateral primary TKA to be performed by Dr. Michael Dayton (University of Colorado Hospital) \n\n Minimum of 110 degrees of active knee flexion \n\n No greater than 10 degrees of anatomic knee varus, 15 degrees anatomic valgus, and 10 degrees flexion contracture \n\n Body mass index less \u2264 40 kg/m2 \n\n ", - "exclusion_criteria": ": \n\n Any brain, circulation, or heart problems that limit function \n\n Severe osteoarthritis or other orthopedic conditions that limit function in the lower extremity that is not undergoing the TKA", - "brief_summary": "Osteoarthritis (OA) is a long-term degenerative joint disease that disables about 10% of people over the age of 60 and compromises the quality of life of more than 20 million Americans. A procedure called total knee arthroplasty (TKA), in which the affected surface of the knee joint is replaced by plastic or metal, has been successful in restoring comfort and mobility to formerly arthritic joints. This study will compare quadriceps muscle strength, knee range of motion, and pain in people who have had a traditional TKA with those who have had a minimally invasive TKA.", - "NCTID": "NCT00710840" - }, - { - "brief_title": "Unrestricted Rehabilitation Following Primary THA", - "phase": "", - "drugs": "['Unrestricted rehabilitation', 'Standard rehabilitation']", - "drugs_list": [ - "Unrestricted rehabilitation", - "Standard rehabilitation" - ], - "diseases": "['Osteoarthritis, Hip']", - "diseases_list": [ - "Osteoarthritis", - "Hip" - ], - "enrollment": "10.0", - "inclusion_criteria": "inclusion criteria: \n\n Age greater than 50 years \n\n Undergoing primary total hip arthroplasty at Holland Orthopaedic and Arthritic Centre \n\n ", - "exclusion_criteria": ": \n\n Any previous surgery about the ipsilateral hip \n\n Patients being considered for simultaneous bilateral total hip arthroplasty \n\n Patients with a neuromuscular disorder or recognized hypermobility syndrome \n\n Patients without sufficient language skills to communicate in spoken and written English", - "brief_summary": "The purpose of this study is to determine whether the form of rehabilitation following primary total hip arthroplasty has an influence on patient satisfaction or functional performance in the eighteen weeks following surgery.", - "NCTID": "NCT02079467" - }, - { - "brief_title": "Investigation of Southern Tick-Associated Rash Illness (STARI)", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Southern Tick-Associated Rash Illness']", - "diseases_list": [ - "Southern Tick-Associated Rash Illness" - ], - "enrollment": "3.0", - "inclusion_criteria": "inclusion criteria: \n\n Enrolled in protocol 02-I-0055. \n\n A person who is at least 14 years old. \n\n Acute onset (within 14 days of visit to NIH) of an annular, erythematous, expanding erythema migrans (EM)-like rash that attains a size of at least 5 cm in diameter, when no alternative explanation for the rash can be found, and thought by the study physician to have a high likelihood to be due to STARI (due to exposure history, tick identification). \n\n History of tick bite at the rash site, or potential exposure to ticks in the southeastern and south central United States within 14 days prior to rash onset (including Maryland and Virginia). \n\n Consent to storage of biologic samples for later testing. \n\n ", - "exclusion_criteria": ": \n\n A person who, in the judgment of the investigator, would be at increased risk from the skin biopsy procedure and unlikely to be able to mount a serological response to the agent (for example, bone marrow transplant, B cell deficiency). \n\n EXCLUSION FROM SKIN BIOPSY PORTION OF STUDY: \n\n A person who meets the case definition but whose EM-like rash occurs on the face, neck, scalp, or over the tibia will not be enrolled for purposes of obtaining a skin biopsy specimen. Such a person may enroll for purposes of providing a clinical history and blood samples only. This exclusion also applies to patients with a history of forming large thick scars after skin injuries or surgery, or who have a history of excessive bleeding after cuts or procedures or are taking anticoagulants, or have severe skin disease. Also, patients who have received more than 24 hours of antibiotic treatment for the rash will be excluded from the biopsy. Patient with a history of allergy to lidocaine will also be excluded from the biopsy portion of the study.", - "brief_summary": "This study will evaluate blood and tissue samples for a condition called Southern Tick-Associated Rash Illness (STARI). This is a skin rash resembling erythema migrans, the rash found in people infected with Lyme disease. In the south and southeastern United States, STARI is associated with the bite of the lone star tick. Researchers seek a better understanding of the cause of STARI. Through researchers' knowledge, diagnostic tests could be developed. NIH is conducting this study along with the Centers for Disease Control and Prevention (CDC).~Patients ages 14 years and older who have recently been diagnosed with possible STARI, who have not taken antibiotics for it longer than 1 day, and whose skin does not form large scars may be eligible for this study. About 20 participants will be enrolled over a 5-year period. Patients will visit the NIH Clinical Center for two or three visits. The first visit may last 2 hours. Photographs will be taken of the rash, and a blood sample of about 1-1/2 tablespoons will be collected for tests. Patients will undergo a punch biopsy of three small pieces of skin, from the rash. The area of the skin will be cleaned, and patients will receive a local anesthetic at the biopsy site. A sharp instrument will remove a round plug of skin, about the size of half a pencil eraser. Patients may feel a pushing sensation, but there should not be pain. The site usually heals without sutures, though the doctors may close it with special adhesive bandages or one or two sutures. Patients will receive instructions about how to take care of the biopsy site. If sutures are used, patients will return in 7 to 10 days to have them removed-or a patient's own doctor may remove the sutures. Patients will return to NIH at 4 to 6 weeks following their first visit. At that time, they will answer questions about how they are doing and donate about 2 tablespoons of blood. Blood and skin samples will be used for research at NIH and CDC.~...", - "NCTID": "NCT00358761" - } - ], - "1": [ - { - "brief_title": "Treatment of Stable Both-Bone Midshaft Forearm Fractures in Children", - "phase": "", - "drugs": "['above or below elbow cast for the last 3 weeks of treatment']", - "drugs_list": [ - "above or below elbow cast for the last 3 weeks of treatment" - ], - "diseases": "['Fracture', 'Forearm', 'Midshaft', 'Child', 'Treatment']", - "diseases_list": [ - "Fracture", - "Forearm", - "Midshaft", - "Child", - "Treatment" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n both-bone forearm fracture \n\n age < 16 years \n\n dislocation \n\n stable \n\n ", - "exclusion_criteria": ": \n\n fracture older than 1 week \n\n no informed consent \n\n refracture \n\n open fracture (Gustillo 2 and 3)", - "brief_summary": "We create a randomized clinical trial between the treatment with above elbow armcast alone and the treatment of above elbow in combination with a short arm cast for stable midshaft both-bone forearm fractures.", - "NCTID": "NCT00398242" - }, - { - "brief_title": "Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma", - "phase": "", - "drugs": "['Indomethacin and Pantoprazole', 'microcrystalline cellulose powder tablets']", - "drugs_list": [ - "Indomethacin and Pantoprazole", - "microcrystalline cellulose powder tablets" - ], - "diseases": "['Elbow Trauma Requiring Operative Management']", - "diseases_list": [ - "Elbow Trauma Requiring Operative Management" - ], - "enrollment": "150.0", - "inclusion_criteria": "inclusion criteria: \n\n Terrible Triad \n\n Radial head fracture surgical treatment \n\n Monteggia and Trans-olecranon Fracture Dislocations \n\n Distal Biceps Tendon Injuries \n\n Distal Humerus Fractures \n\n Coronoid Fractures \n\n Capitellar-Trochlear fractures \n\n Olecranon Fractures \n\n ", - "exclusion_criteria": ": \n\n Associated Traumatic Brain Injury \n\n Burn Injuries associated with elbow trauma \n\n History of Gastric Ulcers \n\n Documented allergies to any Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) \n\n Severe Asthma \n\n Previous operative fixation to affected elbow \n\n Participation in other research study \n\n Inability to speak / understand English", - "brief_summary": "Patients who present to our institution with a traumatic injury to their elbow who need operative management will be randomized to one of two groups; a treatment arm and a control arm. The treatment arm will receive a three-week postoperative course of indomethacin while the control group will not. We will follow both groups to assess whether or not indomethacin prophylaxis affects the rate of heterotopic ossification.", - "NCTID": "NCT01744314" - }, - { - "brief_title": "Electrothermal Arthroscopic Capsulorrhaphy (ETAC) and Open Inferior Capsular Shift in Patients With Shoulder Instability", - "phase": "", - "drugs": "['Electrothermal arthroscopic capsulorrhaphy (ETAC)', 'Open inferior capsular shift (ICS)']", - "drugs_list": [ - "Electrothermal arthroscopic capsulorrhaphy (ETAC)", - "Open inferior capsular shift (ICS)" - ], - "diseases": "['Shoulder Dislocation']", - "diseases_list": [ - "Shoulder Dislocation" - ], - "enrollment": "58.0", - "inclusion_criteria": "inclusion criteria: \n\n Ages 14 years or greater \n\n Diagnosis of MDI or MDL-AII. Diagnosis will require two or more of the following: \n\n Symptomatic translation (pain or discomfort) in one or more directions: anterior, inferior and/or posterior; \n\n Ability to elicit unwanted glenohumeral translations that reliably produce symptoms with one of the following tests: the anterior and posterior apprehension tests, the anterior and posterior load and shift tests, the fulcrum test, the relocation test, the Fukuda test, and/or the push-pull or stress test with the patient supine; \n\n Presence of a positive sulcus sign of 1 centimetre or greater gap that reproduces the patient's clinical symptoms of instability and should be both palpable and visible; \n\n Symptoms of instability: subluxation or dislocation. \n\n Written informed consent \n\n Failed at least 6 months of non-operative treatment \n\n Confirmed capsular-ligamentous redundancy as determined by diagnostic arthroscopy examination. \n\n ", - "exclusion_criteria": ": \n\n Neurologic disorder (ie: axillary nerve injury; syringomyelia) \n\n Cases involving third party compensation \n\n Patients with primary posterior instability \n\n A bony abnormality (Hill Sachs/bony Bankart) on standard series of x-rays consisting of a minimum of an anteroposterior view, lateral in the scapular plane and an axillary view \n\n Presence of a Bankart lesion on arthroscopic exam of the joint \n\n Presence of an unstable biceps anchor (ie: superior labral anterior and posterior [SLAP] lesion) on arthroscopic exam of the joint \n\n Presence of a full-thickness rotator cuff tear.", - "brief_summary": "This trial will compare the effectiveness of electrothermal arthroscopic capsulorrhaphy (ETAC) to the current reference standard procedure, open inferior capsular shift (ICS), for the treatment of shoulder instability caused by ligamentous capsular redundancy. Multi-directional instability (MDI) and multi-directional laxity with anteroinferior instability (MDL-AII) are the two types of shoulder instabilities included in this trial.~Hypothesis: There is no difference in disease-specific quality of life between patients undergoing an ETAC versus an open ICS for the treatment of shoulder instability caused by capsular ligamentous redundancy.", - "NCTID": "NCT00251160" - }, - { - "brief_title": "Dislocated Unstable Distal Both-Bone Forearm Fractures in Children", - "phase": "", - "drugs": "['Kirschner-wire fixation']", - "drugs_list": [ - "Kirschner-wire fixation" - ], - "diseases": "['Fracture', 'Forearm', 'Distal', 'Child', 'Treatment']", - "diseases_list": [ - "Fracture", - "Forearm", - "Distal", - "Child", - "Treatment" - ], - "enrollment": "60.0", - "inclusion_criteria": "inclusion criteria: \n\n both-bone forearm fracture \n\n distal \n\n dislocated \n\n unstable after reposition \n\n age < 16 years \n\n ", - "exclusion_criteria": ": \n\n fracture older than 1 week \n\n no informed consent \n\n refracture \n\n open fracture (Gustillo 2 and 3) \n\n both fractures of type torus", - "brief_summary": "We create a follow-up study of Kirschner wire fixation of a unstable dislocated distal both-bone forearm fracture.", - "NCTID": "NCT00398268" - }, - { - "brief_title": "Volar Locked Plating Versus Bridging External Fixation", - "phase": "", - "drugs": "", - "drugs_list": [], - "diseases": "['Distal Radius Fracture']", - "diseases_list": [ - "Distal Radius Fracture" - ], - "enrollment": "166.0", - "inclusion_criteria": "inclusion criteria: \n\n All patients admitted to Ahus and Lillestrom legevakt with a distal radius fracture are to be classified according to the system of the Orthopaedic Trauma Association (AO/OTA). \n\n All patients between the age of 18 and 70 diagnosed with a C2- or C3-type fracture, or a dislocated C1-fracture, are eligible for inclusion. \n\n ", - "exclusion_criteria": ": \n\n Gustillo-Anderson type III open fractures \n\n Previous distal radius/ulna-fracture and/or disabling hand injury of the same extremity \n\n Dementia \n\n Congenital anomaly \n\n Bilateral radius fracture \n\n Pathological fracture other than osteoporotic fracture \n\n Congenital bone disease (for example osteogenesis imperfecta) \n\n Age below 18 and above 70 \n\n Disabling nury to other parts og the movement apparatus at the same time as the current injury", - "brief_summary": "A randomized, prospective comparison of volar locked plating versus Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 & C3.~Hypothesis:~There is no significant difference in using volar plates compared to Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 & C3 as evaluated by a Quick-DASH score at 24 months follow-up.", - "NCTID": "NCT01062997" - } - ], - "2": [] - } -] \ No newline at end of file diff --git a/results/aggregation_results_sigir_gpt-4o.json b/results/aggregation_results_sigir_gpt-4o.json new file mode 100644 index 0000000..d747500 --- /dev/null +++ b/results/aggregation_results_sigir_gpt-4o.json @@ -0,0 +1,724 @@ +{ + "sigir-20141": { + "NCT01397994": { + "relevance_explanation": "The patient presents with episodic chest pain, which is a symptom related to angina, but there is no evidence of chronic stable angina or an abnormal Exercise Myocardial Perfusion Spect Scan, which are key requirements for the trial. The patient is within the age range and is female, which are relevant to the trial's inclusion criteria. However, the lack of a confirmed diagnosis of chronic stable angina significantly reduces the relevance.", + "relevance_score_R": 40.0, + "eligibility_explanation": "The patient meets several inclusion criteria such as age, gender, and willingness to comply with the study protocol. However, the patient does not have a confirmed diagnosis of chronic stable angina, which is a critical inclusion criterion. Additionally, there is insufficient information to confirm or exclude the patient based on some exclusion criteria, such as blood pressure specifics and eligibility for Tc 99m SPECT. Therefore, the patient is not eligible for the trial.", + "eligibility_score_E": -40.0 + }, + "NCT00149227": { + "relevance_explanation": "The patient is relevant to the clinical trial as she has a clinical diagnosis of hypertension, which is a target condition of the trial. Additionally, she has obesity and ECG abnormalities, which are considered risk factors for the trial. These factors align with the trial's focus on high-risk patients with hypertension.", + "relevance_score_R": 90.0, + "eligibility_explanation": "The patient meets the inclusion criteria due to her hypertension and additional risk factors such as obesity and ECG abnormalities. She is not excluded by any of the exclusion criteria, as there is no evidence of ARB use, recent PCI or CABG, severe hypertension, pregnancy, arrhythmia, or severe renal or hepatic impairment. However, there is insufficient information regarding some exclusion criteria, such as renal and hepatic function, which slightly reduces the eligibility score.", + "eligibility_score_E": 80.0 + } + }, + "sigir-20142": { + "NCT00711399": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as he presents with respiratory sounds, specifically cough and shortness of breath, which are the target conditions of the trial. Additionally, the patient and his guardians are willing to provide informed consent, which is a key inclusion criterion.", + "relevance_score_R": 90.0, + "eligibility_explanation": "While the patient meets the inclusion criteria of having cough and shortness of breath and providing informed consent, he is excluded due to being in respiratory distress, which is an exclusion criterion. Therefore, despite being relevant, he is ineligible for the trial.", + "eligibility_score_E": -90.0 + }, + "NCT02618655": { + "relevance_explanation": "The patient presents with an acute fever and respiratory symptoms, which could potentially be related to a tick-borne disease, making the trial relevant. However, the fever duration is only 2 days, which does not fully align with the trial's focus on fever of unknown origin lasting more than one week. The trial aims to diagnose tick-borne diseases, and the patient's recent travel history and symptoms could be relevant, but the short duration of fever limits the relevance.", + "relevance_score_R": 60.0, + "eligibility_explanation": "The patient meets the inclusion criterion of having a temperature higher than 38\u00b0C. However, he does not meet the criterion of having a fever for more than one week, and there is insufficient information regarding the completion of physical and laboratory examinations after one week. The patient is not excluded based on the available exclusion criteria, as there is no indication of a non-infectious cause or automatic discharge. Overall, the patient partially meets the eligibility criteria but lacks key information for full eligibility.", + "eligibility_score_E": 20.0 + } + }, + "sigir-20143": { + "NCT02490059": { + "relevance_explanation": "The patient is relevant to the clinical trial as she has a left lung mass, which could potentially be a solitary pulmonary nodule (SPN), a target condition for the trial. However, the relevance is limited by the lack of confirmation via a CT scan, which is necessary to confirm the presence of a pulmonary nodule. Additionally, there is no information on whether the nodule is non-visible on standard-size bronchoscopy, which is a key aspect of the trial. The patient's willingness to provide informed consent and comply with the trial protocol supports her relevance.", + "relevance_score_R": 60.0, + "eligibility_explanation": "The eligibility of the patient is uncertain due to the lack of specific information confirming the presence of a pulmonary nodule on a CT scan and the visibility status of the nodule on standard-size bronchoscopy. While the patient is not excluded based on the informed consent criterion, the absence of critical inclusion information limits her eligibility. Therefore, the eligibility score reflects this uncertainty.", + "eligibility_score_E": 0.0 + }, + "NCT01452971": { + "relevance_explanation": "The patient is potentially relevant to the clinical trial as she has a left lung mass, which suggests the possibility of lung cancer. The trial is focused on lung cancer patients, specifically studying the GNMT gene in relation to lung cancer. However, there is no confirmed diagnosis of lung cancer in the patient note, which limits the relevance. The patient's age and ability to comply with the trial protocol are not barriers to participation.", + "relevance_score_R": 70.0, + "eligibility_explanation": "The patient is not confirmed to have lung cancer, which is a key inclusion criterion for the trial. While she is not excluded based on age or the absence of lung cancer, the lack of a confirmed diagnosis means she does not fully meet the inclusion criteria. Therefore, her eligibility is limited by the absence of a definitive lung cancer diagnosis.", + "eligibility_score_E": 0.0 + } + }, + "sigir-20144": { + "NCT02390596": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as he presents with Kawasaki Disease, which is the target condition of the trial. The patient exhibits the necessary clinical signs and symptoms, including fever for 5 days and 4 out of 5 main clinical signs, as well as coronary artery abnormalities, which align with the trial's inclusion criteria for Kawasaki Disease.", + "relevance_score_R": 95.0, + "eligibility_explanation": "The patient meets several inclusion criteria: he is above the age and weight threshold, has Kawasaki Disease with the required clinical signs, and informed consent is available. However, there is insufficient information regarding the patient's response to standard therapy, health insurance status, and several exclusion criteria such as previous biotherapy treatment, immunodeficiency, and TB risk factors. These unknowns prevent a full eligibility determination.", + "eligibility_score_E": 50.0 + }, + "NCT00841789": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as he is a 2-year-old male presenting with symptoms consistent with Kawasaki Disease, which is the target condition of the trial. The trial aims to study the effects of Etanercept in conjunction with IVIG and aspirin in patients with Kawasaki Disease, directly aligning with the patient's condition.", + "relevance_score_R": 95.0, + "eligibility_explanation": "The patient meets all inclusion criteria: he is within the age range, parental consent is provided, and he presents with Kawasaki Disease. However, he is excluded due to laboratory toxicities, specifically elevated alanine aminotransferase and low albumin levels, which may preclude participation. Additionally, the enlarged liver and elevated liver enzymes suggest potential liver issues, further supporting exclusion under criterion 16. These factors significantly impact his eligibility.", + "eligibility_score_E": -50.0 + } + }, + "sigir-20145": { + "NCT00163709": { + "relevance_explanation": "The patient is relevant to the clinical trial as she presents to the emergency department with shortness of breath, which is a primary condition of interest for the trial. Additionally, she is over 40 years old, which aligns with the inclusion criteria. However, there is no information about her triage category, which is necessary to fully assess relevance.", + "relevance_score_R": 80.0, + "eligibility_explanation": "The patient meets the age and symptom criteria for inclusion, as she is over 40 and presents with shortness of breath. There is no evidence of exclusion criteria such as traumatic dyspnea, severe renal disease, cardiogenic shock, or early transfer to another hospital. However, the lack of information about the triage category prevents full confirmation of eligibility.", + "eligibility_score_E": 60.0 + }, + "NCT01935141": { + "relevance_explanation": "The patient presents with symptoms suggestive of a pulmonary embolism, such as shortness of breath and an elevated D-dimer, which are relevant to the trial's focus on detecting emboli using CT pulmonary angiography. However, there is no explicit mention of a referral for a CT pulmonary angiogram, which is a key inclusion criterion for the trial.", + "relevance_score_R": 70.0, + "eligibility_explanation": "The patient does not have any exclusion criteria such as congestive heart failure, supraventricular tachycardia, or a history of contrast allergy. The patient is also able to provide informed consent. However, there is insufficient information regarding a referral for a CT pulmonary angiogram and serum creatinine levels, which are necessary to fully determine eligibility.", + "eligibility_score_E": 30.0 + } + }, + "sigir-20146": { + "NCT00015626": { + "relevance_explanation": "The patient is relevant to the clinical trial as she is obese and has diabetes mellitus, which are target conditions of the trial. The trial aims to address insulin resistance and its complications, which are related to the patient's condition.", + "relevance_score_R": 75.0, + "eligibility_explanation": "The patient meets the inclusion criterion for obesity, but there is insufficient information regarding other inclusion criteria such as specific complications of insulin resistance or family history of type II diabetes. The patient is excluded due to a history of poor compliance with physician's recommendations, which is a significant exclusion criterion.", + "eligibility_score_E": -75.0 + }, + "NCT02512159": { + "relevance_explanation": "The patient is relevant to the clinical trial as she has a skin lesion on the lower leg, which could potentially be a type of ulcer targeted by the trial. Additionally, she has diabetes mellitus, a comorbidity associated with the trial's target conditions. However, there is no direct evidence that the lesion is due to diabetes mellitus, venous stasis, or arterial insufficiency, which slightly reduces the relevance.", + "relevance_score_R": 70.0, + "eligibility_explanation": "The patient meets several inclusion criteria: she is over 18 years old and has diabetes mellitus. She is not excluded by any of the exclusion criteria, as there is no evidence of hemodynamic instability, septic shock, deep ulcers with exposed organs, or other specified conditions. However, there is insufficient information to confirm the presence of basic laboratory tests at admission, and the nature of the skin lesion is not fully clarified to confirm it as an ulcer due to the specified conditions. Therefore, while she is likely eligible, the lack of specific information about the lesion's etiology and laboratory tests slightly reduces the eligibility score.", + "eligibility_score_E": 50.0 + } + }, + "sigir-20147": { + "NCT01863628": { + "relevance_explanation": "The patient is relevant to the clinical trial as she has a diagnosis of bipolar disorder, which is the target condition of the trial. However, the trial specifically targets offspring of parents with bipolar disorder, and there is no information provided about the patient's parental history of bipolar disorder. Additionally, the trial focuses on the prodromal stage of bipolar disorder, and while the patient exhibits symptoms such as depressive mood, anxiety, and agitation, there is no information on whether these symptoms are part of a prodromal phase or the duration of these symptoms.", + "relevance_score_R": 50.0, + "eligibility_explanation": "The patient is ineligible for the trial due to the exclusion criterion of having a DSM-IV defined Axis I disorder, which includes her diagnosis of bipolar disorder. While she exhibits symptoms that could be relevant to the trial's focus on prodromal symptoms, the lack of information about her parental history of bipolar disorder and the exclusion due to her current diagnosis significantly impact her eligibility.", + "eligibility_score_E": -50.0 + }, + "NCT00845988": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as she has a history of bipolar disorder, which is the primary condition being studied. Additionally, she is within the age range specified by the trial. The trial aims to study metabolic complications, and the patient is obese, which may indicate metabolic issues. However, there is no specific information about weight gain after starting her current medication, which slightly reduces relevance.", + "relevance_score_R": 85.0, + "eligibility_explanation": "The patient meets the inclusion criteria for having bipolar disorder and being within the age range. She is willing to provide informed consent, but there is no information about her syndromal remission state, which is necessary for full eligibility. Additionally, while she is obese, there is no specific evidence of weight gain after starting her current medication, which is a key inclusion criterion. She does not meet any exclusion criteria, as there is no mention of eating disorders, substance abuse, psychotic disorders, or other medical illnesses. Overall, the lack of information on weight gain and syndromal remission state limits her eligibility.", + "eligibility_score_E": 40.0 + } + }, + "sigir-20148": { + "NCT01519271": { + "relevance_explanation": "The patient is experiencing severe cognitive deficits and memory dysfunction, which are more advanced than the mild cognitive impairment targeted by the trial. The trial is specifically for patients with mild cognitive impairment in the context of Parkinson's Disease, and there is no mention of Parkinson's Disease in the patient's note. Therefore, the relevance of this patient to the trial is low.", + "relevance_score_R": 20.0, + "eligibility_explanation": "The patient is excluded from the trial due to a likely diagnosis of dementia, as indicated by severe cognitive deficits and memory dysfunction. This directly conflicts with exclusion criterion 3. While the patient can provide informed consent, which meets one inclusion criterion, the presence of dementia makes the patient ineligible for the trial.", + "eligibility_score_E": -20.0 + }, + "NCT01628315": { + "relevance_explanation": "The patient is not relevant to the clinical trial as the trial is focused on patients with relapsing-remitting multiple sclerosis (RRMS), while the patient exhibits symptoms consistent with a neurodegenerative condition, possibly Creutzfeldt-Jakob disease, given the EEG findings and biopsy results. There is no mention of multiple sclerosis or related symptoms in the patient note.", + "relevance_score_R": 0.0, + "eligibility_explanation": "The patient is not eligible for the trial as they do not meet the primary condition of having relapsing-remitting multiple sclerosis, nor is there any indication of prior enrollment in the ASA study or MRI data as required by the trial criteria.", + "eligibility_score_E": 0.0 + } + }, + "sigir-20149": { + "NCT01950026": { + "relevance_explanation": "The patient is potentially relevant to the clinical trial as she is visiting a dermatologist for skin lesions, which may involve skin sensitivity or conditions that could be relevant to a study on skin temperature changes after cryotherapy. However, the trial specifically targets body temperature changes in different ethnic groups, and there is no information about the patient's ethnic background in the note.", + "relevance_score_R": 50.0, + "eligibility_explanation": "The patient note does not provide information about the patient's ethnic group, which is necessary for inclusion. However, there is no indication of any exclusion criteria being met, such as changes in skin sensitivity or infectious diseases. Therefore, the patient is not excluded but also not confirmed eligible due to lack of information on the inclusion criterion.", + "eligibility_score_E": 0.0 + }, + "NCT02615912": { + "relevance_explanation": "The patient is relevant to the clinical trial as she is visiting a dermatologist for skin lesions, which could be related to skin conditions like dermatitis. The trial aims to study skin microflora dynamics in response to surfactants, which could be relevant to understanding skin conditions. However, the trial specifically targets dermatitis, and the patient note does not explicitly mention dermatitis, which slightly reduces relevance.", + "relevance_score_R": 60.0, + "eligibility_explanation": "The patient is ineligible for the trial due to the exclusion criterion that disqualifies subjects with visible skin conditions. The patient has multiple lesions on her neck, which are considered a visible skin condition, thus excluding her from participation.", + "eligibility_score_E": -60.0 + } + }, + "sigir-201410": { + "NCT02264964": { + "relevance_explanation": "The patient underwent cardiac catheterization via the right femoral artery, which is not directly related to the trial's focus on central venous catheterization for hemodialysis. The trial targets patients with chronic renal failure requiring hemodialysis, a condition not mentioned in the patient note. However, the patient is willing to provide informed consent, which is relevant to the trial's requirements.", + "relevance_score_R": 20.0, + "eligibility_explanation": "The patient meets the criterion of providing informed consent. However, there is no information indicating that the patient has chronic renal failure requiring hemodialysis, which is a primary inclusion criterion. Additionally, there is no evidence of the patient having undergone central venous catheterization, which is relevant for both inclusion and exclusion criteria. Therefore, the eligibility is limited due to the lack of information on key criteria.", + "eligibility_score_E": 5.0 + }, + "NCT02097186": { + "relevance_explanation": "The patient underwent cardiac catheterization, which is a vascular procedure, but there is no indication that she is undergoing any of the specific surgeries targeted by the trial, such as carotid endarterectomy, abdominal aortic aneurysm repair, or lower limb revascularization. Therefore, the relevance to the trial is limited.", + "relevance_score_R": 30.0, + "eligibility_explanation": "The patient meets the basic inclusion criteria of age and willingness to provide informed consent. However, there is no information indicating that she is undergoing any of the specific surgeries required for inclusion in the trial. Additionally, there is insufficient information to determine if any exclusion criteria apply. Thus, the eligibility is low.", + "eligibility_score_E": 5.0 + } + }, + "sigir-201411": { + "NCT01723137": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as she presents with acute pain, which is the target condition of the study. The trial aims to measure changes in acute pain using patient-reported scales, and the patient reports excruciating pain, which is likely to be greater than 3 out of 10 on the pain scale. Additionally, the patient is alert, over 18 years of age, and able to provide informed consent, aligning with the trial's inclusion criteria.", + "relevance_score_R": 95.0, + "eligibility_explanation": "The patient meets the inclusion criterion of reporting pain greater than or equal to 3 out of 10, as she presents with excruciating pain. She is 40 years old, which satisfies the age requirement of being at least 18 years old. The patient is alert and able to provide informed consent, which means she does not meet the exclusion criteria of decreased level of consciousness or inability to answer questions. There is no information suggesting she is a prisoner, so she is not excluded on that basis. Therefore, the patient is fully eligible for the trial.", + "eligibility_score_E": 95.0 + }, + "NCT01526382": { + "relevance_explanation": "The patient presents with symptoms that may suggest shock, such as hypotension and tachycardia, which are relevant to the trial's focus on septic shock. However, there is no direct diagnosis of shock or ARDS, which are the primary conditions targeted by the trial. The patient's symptoms align with some of the inclusion criteria, such as tachycardia and tachypnea, but the lack of a confirmed diagnosis of shock or ARDS limits the relevance.", + "relevance_score_R": 60.0, + "eligibility_explanation": "The patient meets some inclusion criteria, such as having a heart rate over 90/min and a respiratory rate over 20/min, which are indicative of potential shock. However, there is insufficient information to confirm other critical criteria, such as the use of vasopressors, signs of hypoperfusion, or a confirmed diagnosis of ARDS. The patient is not excluded based on the available exclusion criteria, but the lack of comprehensive data on key inclusion criteria limits eligibility.", + "eligibility_score_E": 20.0 + } + }, + "sigir-201412": { + "NCT01551498": { + "relevance_explanation": "The patient presents with symptoms suggestive of thyroid dysfunction, such as fatigue, hair loss, voice change, weight gain, and cold intolerance, along with a cervical mass, which could indicate thyroiditis. These symptoms align with the target condition of autoimmune thyroiditis being studied in the trial. However, there is no direct evidence of autoimmune thyroiditis, such as positive thyroid peroxidase antibodies or sonographic evidence, which are key inclusion criteria.", + "relevance_score_R": 70.0, + "eligibility_explanation": "The patient meets the age criterion and does not have any known exclusions such as end-stage thyroiditis or use of prohibited medications. However, there is insufficient information regarding the presence of thyroid peroxidase antibodies and sonographic evidence of Hashimoto's thyroiditis, which are necessary for inclusion. Without this information, the patient's eligibility remains uncertain.", + "eligibility_score_E": 0.0 + }, + "NCT00271427": { + "relevance_explanation": "The patient presents with symptoms that are consistent with thyroid issues, such as fatigue, hair loss, weight gain, and a cervical mass, which could suggest a thyroid disorder like autoimmune thyroiditis. However, there is no direct evidence in the patient note of a clinical diagnosis of autoimmune thyroiditis or Hashimoto's Thyroiditis, nor is there mention of the patient using LT4, which is a key inclusion criterion for the trial. Therefore, while the symptoms suggest potential relevance, the lack of a confirmed diagnosis and LT4 use limits the relevance to the trial.", + "relevance_score_R": 50.0, + "eligibility_explanation": "The patient does not meet the inclusion criterion as there is no confirmed diagnosis of autoimmune thyroiditis or use of LT4 mentioned in the patient note. Additionally, there is no information provided that would exclude the patient based on the exclusion criteria, such as the use of other medications or known pathologies affecting GIS absorption. However, the lack of a confirmed diagnosis and LT4 use makes the patient ineligible for the trial.", + "eligibility_score_E": -50.0 + } + }, + "sigir-201413": { + "NCT02264769": { + "relevance_explanation": "The patient is a postpartum woman, which is relevant to the trial's focus on postpartum hemorrhage. However, the trial specifically targets women undergoing elective cesarean delivery, and this patient had a natural birth. Therefore, while she is somewhat relevant due to the postpartum context, she does not meet the primary inclusion criterion of having an elective cesarean delivery.", + "relevance_score_R": 40.0, + "eligibility_explanation": "The patient meets the inclusion criteria for providing informed consent and having a term pregnancy. However, she does not meet the primary inclusion criterion of having undergone an elective cesarean delivery, which is crucial for this trial. There are no exclusion criteria that apply to her, but the lack of meeting the primary inclusion criterion significantly impacts her eligibility.", + "eligibility_score_E": 10.0 + }, + "NCT00163709": { + "relevance_explanation": "The patient presented to the Emergency Department with shortness of breath, which is the primary condition of interest for the trial. However, the trial specifically targets patients over 40 years old, and the patient is only 30 years old. This significantly reduces the relevance of the trial to the patient.", + "relevance_score_R": 30.0, + "eligibility_explanation": "The patient does not meet the inclusion criterion of being over 40 years old, which makes her ineligible for the trial. There are no exclusion criteria that apply to her, but the failure to meet the age requirement is sufficient to determine ineligibility.", + "eligibility_score_E": -30.0 + } + }, + "sigir-201414": { + "NCT01624545": { + "relevance_explanation": "The patient is relevant to the clinical trial as he is 85 years old, which meets the age criterion of being 18 years or older. Additionally, he is willing to provide informed consent and comply with the trial protocol, which is another inclusion criterion. However, the patient does not have a newly diagnosed chronic subdural hematoma operated within the last 48 hours, which is a critical inclusion criterion for the trial. This significantly reduces the relevance of the patient to the trial, as the primary focus is on patients who have undergone recent surgery for chronic subdural hematoma.", + "relevance_score_R": 40.0, + "eligibility_explanation": "The patient meets the age criterion and is willing to provide informed consent, which are positive indicators for eligibility. He is not excluded by any of the exclusion criteria provided, such as being in a moribund state, having geographic follow-up difficulties, or having a CSH due to specific conditions. However, the patient does not meet the critical inclusion criterion of having a newly diagnosed chronic subdural hematoma operated within the last 48 hours, which is essential for participation in the trial. This makes the patient ineligible for the trial despite meeting other criteria.", + "eligibility_score_E": -40.0 + }, + "NCT01869855": { + "relevance_explanation": "The patient is an 85-year-old male, which satisfies the age requirement for the trial. However, there is no mention of the patient having a chronic subdural hematoma, which is the primary condition being studied in the trial. Without evidence of this condition, the relevance to the trial is significantly reduced.", + "relevance_score_R": 20.0, + "eligibility_explanation": "The patient does not meet the inclusion criteria as there is no indication of a chronic subdural hematoma verified on cranial CT or MRI. While the patient is willing to provide informed consent, this alone does not make him eligible for the trial. There is no information suggesting exclusion based on the criteria provided, but the lack of inclusion criteria fulfillment results in ineligibility.", + "eligibility_score_E": -20.0 + } + }, + "sigir-201415": { + "NCT00180739": { + "relevance_explanation": "The patient is a 36-year-old woman with a differential diagnosis that includes uterine fibroids, which aligns with the target condition of the clinical trial. The trial is focused on women with uterine fibroids who wish to pursue pregnancy, and the patient is within the age range specified in the inclusion criteria. Additionally, the patient is willing to provide informed consent and comply with the trial protocol, which is relevant to the trial's requirements.", + "relevance_score_R": 80.0, + "eligibility_explanation": "The patient meets the age requirement and has a differential diagnosis that includes fibroids, making her potentially eligible. She is not pregnant, as confirmed by a negative pregnancy test, and her uterine size is within the acceptable range. However, there is insufficient information regarding her fertility history, ovarian function, use of non-steroidal treatments, MRI visibility of fibroids, and other specific trial requirements. Therefore, while she is not excluded by any criteria, the lack of detailed information on several inclusion criteria limits her eligibility.", + "eligibility_score_E": 40.0 + }, + "NCT00277680": { + "relevance_explanation": "The patient presents with symptoms that could be associated with uterine fibroids, such as an enlarged uterus and abdominal tenderness. The differential diagnosis includes fibroid degeneration, which aligns with the target condition of the trial. However, there is no explicit mention of menorrhagia or bulk symptoms, which are key inclusion criteria for the trial. Despite this, the potential presence of fibroids makes the trial relevant to the patient.", + "relevance_score_R": 70.0, + "eligibility_explanation": "The patient is not excluded by most of the exclusion criteria, such as malignancy, current pregnancy, or being postmenopausal. However, the exclusion criterion regarding uterus size exceeding the umbilical level is likely met, as the physical exam notes an 18-week sized uterus, which typically exceeds the umbilical level. This makes the patient ineligible for the trial despite the relevance of her condition.", + "eligibility_score_E": -70.0 + } + }, + "sigir-201416": { + "NCT02238756": { + "relevance_explanation": "The patient is relevant to the clinical trial as she is experiencing symptoms consistent with rabies, which is the target condition of the trial. The trial aims to investigate the safety and tolerability of a rabies vaccine, which is pertinent given the patient's symptoms of hydrophobia and other neurological signs suggestive of rabies.", + "relevance_score_R": 90.0, + "eligibility_explanation": "The patient is excluded from the trial due to the presence of acute disease symptoms such as spastic arm movements, sweating, agitation, anxiety, malaise, difficulty swallowing, and hydrophobia, which are likely to interfere with the safety assessment of the investigational products. Although she meets some inclusion criteria, the acute nature of her symptoms makes her ineligible.", + "eligibility_score_E": -90.0 + }, + "NCT02374814": { + "relevance_explanation": "The patient is relevant to the clinical trial as she is a 28-year-old female, which fits the age and gender criteria for the trial. Additionally, she is able to provide informed consent and comply with the trial protocol, as indicated in the patient note. The trial is focused on rabies pre-exposure prophylaxis, and the patient's symptoms and recent history suggest a potential rabies exposure, making the trial relevant to her current medical situation.", + "relevance_score_R": 90.0, + "eligibility_explanation": "The patient meets the inclusion criteria regarding age, gender, and ability to provide informed consent. However, there is insufficient information regarding exclusion criteria such as pregnancy status, participation in other clinical trials, previous rabies vaccination, or rabies immune globulin administration. Additionally, while the patient exhibits anxiety and agitation, it is unclear if these symptoms constitute a major psychiatric disorder that would exclude her from the trial. Therefore, while she is likely eligible, the lack of information on these exclusion criteria prevents a full eligibility confirmation.", + "eligibility_score_E": 45.0 + } + }, + "sigir-201417": { + "NCT01745731": { + "relevance_explanation": "The patient is relevant to the clinical trial as he meets several key inclusion criteria. He is 48 years old, which satisfies the age requirement. He has a ruptured liver abscess, which qualifies as a liver space-occupying lesion and a liver injury threatening the viability of the remaining liver tissue, both of which are relevant to the trial's focus on liver conditions requiring extended hepatic resection. Additionally, the patient is willing to provide informed consent and comply with the trial protocol, which is a necessary condition for participation.", + "relevance_score_R": 80.0, + "eligibility_explanation": "The patient meets several inclusion criteria: he is of the appropriate age, has a liver space-occupying lesion, and is willing to provide informed consent. He does not meet any exclusion criteria based on the available information. However, there is insufficient information regarding several other inclusion criteria, such as standard analytical parameters, leukocyte, neutrophil, and platelet counts, as well as AST/ALT and creatinine levels. Despite this, the absence of exclusion criteria and the fulfillment of key inclusion criteria suggest a moderate level of eligibility.", + "eligibility_score_E": 40.0 + }, + "NCT02556359": { + "relevance_explanation": "The patient is relevant to the clinical trial because he has a history of Common Variable Immunodeficiency (CVID), which is one of the primary conditions being studied in the trial. However, the trial also targets immune deficiency and early bone marrow failure (BMF) in childhood, which does not apply to this patient as he is 48 years old. Therefore, while the patient is relevant due to his CVID, he does not meet the age-related aspect of the trial's target conditions.", + "relevance_score_R": 60.0, + "eligibility_explanation": "The patient is eligible based on the inclusion criterion for Common Variable Immunodeficiency (CVID), as he has a history of this condition. He is not excluded based on the criterion of refusal to consent, as he is willing to provide informed consent. However, there is no information indicating that the patient is a genetic patient, which is another inclusion criterion, and he does not meet the age-related criterion for early BMF in childhood. Therefore, while he meets some criteria, he does not fully meet all the inclusion criteria, particularly the age-related one.", + "eligibility_score_E": 30.0 + } + }, + "sigir-201418": { + "NCT00557219": { + "relevance_explanation": "The patient is relevant to the clinical trial as he is experiencing oliguria and has risk factors for acute renal failure, which are key conditions being studied in the trial. However, it is not confirmed that the surgery was cardiac, which is a specific requirement of the trial.", + "relevance_score_R": 70.0, + "eligibility_explanation": "The patient meets several inclusion criteria: he has oliguria with urine output < 0.2 mL/kg/hr and risk factors for acute renal failure such as generalized edema and elevated serum creatinine. He is not excluded based on the available exclusion criteria, as he does not have chronic renal failure or a serum creatinine level > 2 mg/dL. However, there is insufficient information regarding the type of surgery (cardiac) and the administration of furosemide, which are critical for full eligibility.", + "eligibility_score_E": 40.0 + }, + "NCT01260883": { + "relevance_explanation": "The patient is a 6-month-old infant who has undergone major surgery, which aligns with the trial's focus on postoperative infants aged 2 to 18 months. This makes the patient highly relevant to the trial.", + "relevance_score_R": 90.0, + "eligibility_explanation": "While the patient meets the inclusion criteria of being a postoperative infant within the specified age range, he is excluded due to potential renal issues indicated by elevated blood urea nitrogen and serum creatinine levels. This exclusion is based on the trial's criterion regarding renal disease.", + "eligibility_score_E": -90.0 + } + }, + "sigir-201419": { + "NCT00256529": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as he is a 52-year-old man presenting with progressive dysphagia, which aligns with the trial's focus on patients with dysphagia to determine the presence of eosinophilic esophagitis. The patient's symptoms and age fit the inclusion criteria for the study.", + "relevance_score_R": 90.0, + "eligibility_explanation": "The patient meets the age and symptom criteria for inclusion. There is no information suggesting he has significant cardiopulmonary disease or contraindications to EGD, nor is there evidence of esophageal varices, which are exclusion criteria. He is willing to provide informed consent and comply with the trial protocol. However, there is insufficient information regarding his ability to undergo EGD and biopsies, which slightly affects the eligibility score.", + "eligibility_score_E": 80.0 + }, + "NCT02509286": { + "relevance_explanation": "The patient presents with progressive dysphagia and significant weight loss, which are symptoms consistent with esophageal adenocarcinoma, a target condition of the trial. However, there is no histological confirmation of adenocarcinoma, which is crucial for relevance. The patient's age is appropriate for the trial, and he is willing to provide informed consent, which aligns with the trial's requirements.", + "relevance_score_R": 60.0, + "eligibility_explanation": "The patient meets the age criterion and is willing to provide informed consent, which are two inclusion criteria. However, there is insufficient information regarding the histological confirmation of adenocarcinoma, cancer staging, and other health parameters such as cardiac, bone marrow, respiratory, renal, and liver functions. Additionally, there is no information on exclusion criteria such as tumor histology, operability, or prior treatments. Therefore, the eligibility is limited by the lack of comprehensive clinical data.", + "eligibility_score_E": 10.0 + } + }, + "sigir-201420": { + "NCT01594385": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as she is a trauma patient with abdominal issues, likely undergoing damage control/open abdomen management, which aligns with the trial's focus on trauma patients with open abdomen conditions. Additionally, she is 32 years old, meeting the age criterion for the trial.", + "relevance_score_R": 90.0, + "eligibility_explanation": "The patient meets the inclusion criteria of being a trauma patient undergoing potential damage control/open abdomen management and is over 18 years old. There is no information suggesting she is a prisoner or pregnant, thus not excluded by those criteria. However, there is insufficient information regarding her life expectancy, which is a necessary inclusion criterion. This lack of information slightly reduces her eligibility score.", + "eligibility_score_E": 70.0 + }, + "NCT02255487": { + "relevance_explanation": "The patient is relevant to the clinical trial as she is a 32-year-old woman who has sustained abdominal trauma, which aligns with the trial's focus on patients undergoing open abdominal laparotomy for abdominal trauma or acute surgical abdomen. However, it is not explicitly stated whether she requires an open abdominal laparotomy, which is a key aspect of the trial's inclusion criteria.", + "relevance_score_R": 70.0, + "eligibility_explanation": "The patient meets the basic inclusion criteria of age and consent. However, there is insufficient information to confirm if she requires an open abdominal laparotomy, which is crucial for eligibility. There are no indications that she meets any exclusion criteria, but the lack of information on the necessity of surgery limits her eligibility.", + "eligibility_score_E": 20.0 + } + }, + "sigir-201421": { + "NCT01520155": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as she has systemic Lupus erythematosus (SLE), which is the target condition of the study. The patient's symptoms, such as arthralgias, rash, alopecia, and laboratory findings including positive ANA and anti-dsDNA, normocytic anemia, thrombocytopenia, and renal involvement (proteinuria and RBC casts), strongly indicate SLE. This aligns with the trial's focus on assessing cardiovascular risk in SLE patients.", + "relevance_score_R": 95.0, + "eligibility_explanation": "The patient is fully eligible for the trial as she meets the inclusion criterion of having systemic Lupus erythematosus and is not excluded by any criteria. The trial aims to study cardiovascular risk in SLE patients, and the patient's renal involvement is also relevant to the study's objectives. There are no exclusion criteria that apply to her, making her a suitable candidate for the trial.", + "eligibility_score_E": 95.0 + }, + "NCT00997100": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as she has been diagnosed with Systemic Lupus Erythematosus (SLE), which is the target condition of the trial. She presents with symptoms such as arthritis, rash, and renal involvement, which align with the trial's focus on mild active SLE with symptoms from skin, mouth, and/or joints.", + "relevance_score_R": 90.0, + "eligibility_explanation": "The patient meets several inclusion criteria, such as being over 18 years old, fulfilling at least 4 ACR criteria for SLE, and presenting with active SLE symptoms including arthritis and skin rash. However, she is excluded due to active renal lupus, as indicated by protein and RBC casts in her urine, which is a disqualifying factor according to the exclusion criteria.", + "eligibility_score_E": -90.0 + } + }, + "sigir-201422": { + "NCT00723788": { + "relevance_explanation": "The patient is a 15-year-old girl presenting to the ER with symptoms consistent with appendicitis, including right lower quadrant pain and a markedly edematous appendix on ultrasound. This aligns perfectly with the trial's target condition of appendicitis in children and the inclusion criterion of being aged 8-18 years, referred from the emergency department for suspected appendicitis, and having received an ultrasound. Therefore, the patient is highly relevant to the trial.", + "relevance_score_R": 100.0, + "eligibility_explanation": "The patient meets the inclusion criterion as she is within the age range of 8-18 years, presents with suspected appendicitis, and has undergone an abdominal ultrasound. There are no indications of exclusion criteria such as issues with MRI metal screening, claustrophobia, or the need for sedation. Thus, the patient is fully eligible for the trial.", + "eligibility_score_E": 100.0 + }, + "NCT00236912": { + "relevance_explanation": "The patient is relevant to the clinical trial as she presents with symptoms of appendicitis, which is the target condition of the study. However, the trial specifically targets complicated appendicitis, which involves a ruptured appendix, and there is no evidence in the patient note that her appendicitis is complicated. Therefore, while she is relevant to the general condition being studied, she does not fully match the specific condition of interest.", + "relevance_score_R": 60.0, + "eligibility_explanation": "The patient does not meet the inclusion criterion of having complicated appendicitis, as there is no evidence of a ruptured appendix. Additionally, there is insufficient information regarding her ability to take oral medication post-surgery and her use of birth control. On the exclusion side, there is no information suggesting she meets any exclusion criteria, but the lack of evidence for complicated appendicitis significantly impacts her eligibility.", + "eligibility_score_E": -30.0 + } + }, + "sigir-201423": { + "NCT02219360": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as he presents with symptoms consistent with an acute exacerbation of chronic obstructive pulmonary disease (COPD), which is the target condition of the trial. The patient is 63 years old, meeting the age criterion of being over 40. Although the note does not explicitly state that the patient is hospitalized, the severity of symptoms and the use of home oxygen suggest a potential hospitalization, which aligns with the trial's focus on hospitalized patients.", + "relevance_score_R": 90.0, + "eligibility_explanation": "The patient meets the inclusion criterion of being over 40 years old and is likely experiencing an acute exacerbation of COPD, which is the primary condition for inclusion. He is not excluded based on the available exclusion criteria, as there is no evidence of congestive heart failure on the chest x-ray, and no mention of serious cardiac, renal, or hepatic issues. However, there is insufficient information regarding a chest CT to rule out other exclusionary conditions such as lung cancer or interstitial lung diseases. The lack of explicit confirmation of hospitalization slightly reduces the eligibility certainty.", + "eligibility_score_E": 70.0 + }, + "NCT00170222": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as he presents with symptoms consistent with an acute exacerbation of COPD, which is the primary focus of the trial. The trial aims to evaluate the efficacy of antibiotics in such cases, and the patient's symptoms, including cough, shortness of breath, and the need for home oxygen, align with the trial's target condition.", + "relevance_score_R": 90.0, + "eligibility_explanation": "The patient meets the key inclusion criteria of having an acute exacerbation of COPD and the ability to take oral medication. There is no information suggesting he is excluded based on the exclusion criteria provided. However, there is insufficient information regarding his ability to perform lung function tests and whether he has received any pretreatment with antibiotics or corticosteroids, which are critical for full eligibility assessment. Therefore, while he is likely eligible, the lack of complete information on some criteria slightly reduces the eligibility score.", + "eligibility_score_E": 70.0 + } + }, + "sigir-201424": { + "NCT02229695": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as he is a 33-year-old male who is likely undergoing an emergency laparotomy due to a spleen rupture, which aligns with the trial's focus on patients undergoing temporary abdominal closure following trauma. The trial aims to study the effects of different temporary abdominal closure techniques, which is applicable to this patient's situation.", + "relevance_score_R": 90.0, + "eligibility_explanation": "The patient meets the inclusion criterion as he is an adult male undergoing emergency laparotomy with a likely temporary abdominal closure due to trauma. However, there is a potential concern regarding the exclusion criterion related to survival estimates, as the patient's vital signs are critical (BP: 60/30 mmHg, HR: 140/min). Despite this, there is no direct mention of the surgeon's estimate of survival, so the patient cannot be definitively excluded based on this criterion. Therefore, the patient is likely eligible for the trial.", + "eligibility_score_E": 70.0 + }, + "NCT01771861": { + "relevance_explanation": "The patient is relevant to the clinical trial as he presented to the ER with trauma-related symptoms, specifically a spleen rupture and extended intraperitoneal hemorrhage, which are consistent with the target conditions of trauma and injuries. However, there is no direct evidence that the trauma team was activated, which slightly reduces the relevance.", + "relevance_score_R": 75.0, + "eligibility_explanation": "The patient meets the inclusion criterion of having an Injury Severity Score likely greater than 15 due to the spleen rupture and extended intraperitoneal hemorrhage. However, he is excluded because he was admitted more than 24 hours post-injury, which is a disqualifying factor according to the exclusion criteria.", + "eligibility_score_E": -75.0 + } + }, + "sigir-201425": { + "NCT00282269": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as he has a severe traumatic brain injury, indicated by a GCS of 6/15, which aligns with the trial's target condition. Additionally, the patient is within the specified age range of 1 to 16 years. However, there is no information on whether the patient is mechanically ventilated, which is a requirement for inclusion.", + "relevance_score_R": 80.0, + "eligibility_explanation": "The patient meets the age criterion and has a severe traumatic brain injury with a GCS of 6/15, which suggests potential eligibility. However, the lack of information on mechanical ventilation status and CT scan results limits the ability to fully assess eligibility. The patient does not meet any exclusion criteria based on the available information.", + "eligibility_score_E": 40.0 + }, + "NCT02378311": { + "relevance_explanation": "The patient is an 8-year-old boy who sustained an injury from a bicycle fall, which aligns with the target conditions of the trial focusing on injuries in children related to cycling. The trial aims to investigate injuries associated with handlebar impacts, and the patient's incident involved a bicycle, making him relevant to the study.", + "relevance_score_R": 90.0, + "eligibility_explanation": "The patient meets all inclusion criteria: he is within the age range (0-15 years), presented to a hospital for treatment, sustained an injury, and the incident involved a non-motorized bicycle. He is not excluded by any exclusion criteria, as there is no indication of involvement in a motor vehicle collision, injury by another rider, or the presence of 'bull bars' on the bicycle. Additionally, the patient can provide informed consent, and he was not dead on arrival or during admission.", + "eligibility_score_E": 90.0 + } + }, + "sigir-201427": { + "NCT01187901": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as he is 21 years old and has a family history of multiple colonic polyps, which suggests a clinical diagnosis of familial adenomatous polyposis (FAP). This aligns with the trial's target condition of adenomatous polyposis coli. Additionally, the patient is willing to provide informed consent, which is a requirement for participation.", + "relevance_score_R": 90.0, + "eligibility_explanation": "The patient meets the key inclusion criterion of being 18 years or older with a clinical diagnosis of FAP. He is also willing to provide informed consent. However, there is insufficient information regarding other inclusion criteria such as the presence of duodenal polyps, recent surgeries, WHO performance status, bone marrow function, liver function, and NSAID use. Similarly, there is no information on exclusion criteria such as prior investigational drug use, recent malignancies, severe medical conditions, cardiac issues, lung function, infections, liver disease, and laboratory values. Therefore, while the patient is likely eligible based on the available information, the lack of data on several criteria prevents a full eligibility determination.", + "eligibility_score_E": 45.0 + }, + "NCT01713881": { + "relevance_explanation": "The patient is relevant to the clinical trial as he has been found to have colonic adenomas, which aligns with the trial's focus on colon adenoma surveillance. The trial is a retrospective chart review of patients with tubular adenomas found during colonoscopy, and while the patient had adenomas found during sigmoidoscopy, this is closely related and relevant. Additionally, the patient is over 18 years old, meeting the age criterion for relevance.", + "relevance_score_R": 80.0, + "eligibility_explanation": "The patient meets the inclusion criteria as he is over 18 years old and has adenomas found on sigmoidoscopy, which is similar to colonoscopy. There are no exclusion criteria that apply to him, as there is no mention of a diagnosis of IBD, and he is not under 18. Therefore, the patient is fully eligible for the trial.", + "eligibility_score_E": 80.0 + } + }, + "sigir-201429": { + "NCT00703417": { + "relevance_explanation": "The patient is a postmenopausal woman with a history of diabetes, which aligns with the trial's focus on postmenopausal women with type II diabetes. However, she is only 51 years old, which is below the required age range of 55-75 years. Additionally, her diabetes is diet-controlled, and there is no evidence of it being treated with insulin or oral therapies, which is a requirement for the trial. These factors significantly reduce her relevance to the trial.", + "relevance_score_R": 30.0, + "eligibility_explanation": "The patient does not meet the age criterion as she is 51 years old, below the required 55-75 years. Her diabetes is diet-controlled, not treated with insulin or oral therapies, which is necessary for inclusion. There is no information on her BMI, and she has no history of fractures, which are important for the trial. She does not meet any exclusion criteria, but the lack of inclusion criteria fulfillment makes her ineligible.", + "eligibility_score_E": -30.0 + }, + "NCT01978834": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as she is a 51-year-old female, which fits the target demographic of the study focusing on women aged 50 to 89 years. Additionally, she is concerned about osteoporosis, which is the condition being studied in the trial.", + "relevance_score_R": 95.0, + "eligibility_explanation": "The patient meets all the inclusion criteria: she is female and within the age range of 50 to 89 years. She does not meet any of the exclusion criteria: there is no indication that she has opted out of research contact, she can provide informed consent, there is no mention of infeasibility of hip BMD measurement, and there are no open wounds that would preclude ultrasound measurements. Therefore, she is fully eligible for the trial.", + "eligibility_score_E": 95.0 + } + }, + "sigir-201430": { + "NCT00721006": { + "relevance_explanation": "The patient is relevant to the clinical trial as he is a 72-year-old male with symptoms of claudication, which aligns with the trial's focus on severe leg ischemia and peripheral artery disease. The trial targets patients with double-sided claudication and poor circulation, which is consistent with the patient's symptoms of calf pain when walking uphill and diminished pulses in the lower extremities. However, there is no specific mention of an ABI measurement or resting ischemic pain, which are part of the inclusion criteria.", + "relevance_score_R": 75.0, + "eligibility_explanation": "The patient meets the age criterion and has claudication, which are part of the inclusion criteria. He is not excluded based on the ability to provide informed consent or recent myocardial infarction. However, there is insufficient information regarding ABI measurements, resting ischemic pain, or candidacy for surgical procedures, which are crucial for full eligibility. Additionally, there is no information on previous angiogenic therapy, sensitivity to certain medications, or WBC count, which could affect eligibility. Therefore, while the patient is not explicitly excluded, the lack of information on key inclusion criteria limits the eligibility score.", + "eligibility_score_E": 30.0 + }, + "NCT02273232": { + "relevance_explanation": "The patient exhibits symptoms consistent with peripheral arterial disease (PVD), such as calf pain when walking and diminished pulses in the lower extremities. These symptoms align with the target condition of the trial, which is focused on patients with peripheral arterial diseases. However, there is no explicit diagnosis of moderate PVD or staging information (Rutherford or Fontaine) provided in the patient note, which limits the relevance. The trial aims to study the effects of remote ischemic preconditioning on PVD, and the patient's symptoms suggest potential relevance to the trial's objectives.", + "relevance_score_R": 70.0, + "eligibility_explanation": "The patient shows symptoms indicative of PVD, which is relevant for the trial. However, there is insufficient information to confirm eligibility based on the inclusion criteria, as there is no explicit diagnosis of moderate PVD or staging information. The patient does not meet any exclusion criteria, such as severe cardiac or respiratory conditions, upper limb PVD, or contraindications for MRA. Therefore, while the patient is not explicitly excluded, the lack of detailed inclusion criteria fulfillment results in a neutral eligibility status.", + "eligibility_score_E": 0.0 + } + }, + "sigir-20151": { + "NCT01142245": { + "relevance_explanation": "The patient is relevant to the clinical trial as he presents with symptoms consistent with upper gastrointestinal bleeding, which could be due to a peptic ulcer. The trial is focused on preventing recurrent bleeding from peptic ulcers, which aligns with the patient's condition. However, there is no confirmation of ulcer bleeding with Forrest classification, which is a key inclusion criterion.", + "relevance_score_R": 70.0, + "eligibility_explanation": "The patient meets the age criterion and is willing to provide informed consent, which satisfies two inclusion criteria. However, there is no confirmation of ulcer bleeding with Forrest classification, and no information about endoscopic hemostasis being achieved, which are critical for inclusion. The patient does not meet any exclusion criteria based on the available information, but the lack of confirmation of ulcer bleeding and endoscopic hemostasis limits eligibility.", + "eligibility_score_E": 20.0 + }, + "NCT00843063": { + "relevance_explanation": "The patient presents with upper gastrointestinal bleeding, which is relevant to the trial's focus on peptic ulcers/erosions. However, there is no information about the use of low-dose aspirin, which is a key aspect of the trial. The patient's age is appropriate for the trial, but the lack of information on aspirin use and endoscopic findings limits the relevance.", + "relevance_score_R": 40.0, + "eligibility_explanation": "The patient meets the age criterion but lacks information on several key inclusion criteria, such as the use of low-dose aspirin and endoscopic findings of ulcers or erosions. There is also insufficient information to assess most exclusion criteria. Therefore, the eligibility is limited due to missing critical information.", + "eligibility_score_E": 0.0 + } + }, + "sigir-20152": { + "NCT02532452": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as he is immunocompromised and has evidence of a viral infection, which aligns with the trial's target conditions. The trial aims to treat viral infections in immunocompromised hosts, and the patient fits this profile. Additionally, the patient is willing to provide informed consent, which is a requirement for participation.", + "relevance_score_R": 90.0, + "eligibility_explanation": "The patient meets several inclusion criteria: he is immunocompromised with a viral infection, is over 1 day old, and is willing to provide informed consent. However, there is insufficient information regarding the tapering of steroids, the ability to receive treatment in Cincinnati, and whether he has had a stem cell transplant. The patient does not meet any exclusion criteria, as there is no mention of GVHD, bacterial or fungal infections, malignancy relapse, or recent infusion of ATG or alemtuzumab. Overall, the patient is likely eligible but requires further information on certain criteria.", + "eligibility_score_E": 60.0 + }, + "NCT00034437": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as he is within the specified age range (18-65 years) and has evidence of a cytomegalovirus (CMV) infection, indicated by the presence of owl's eye inclusion bodies. Additionally, the patient is willing to provide informed consent, which is a requirement for participation in the trial.", + "relevance_score_R": 90.0, + "eligibility_explanation": "While the patient meets the inclusion criteria of age, CMV seropositivity, and willingness to provide informed consent, he is excluded due to being on immunosuppressive medications, which indicates an immunodeficiency state. This is a disqualifying factor according to the trial's exclusion criteria.", + "eligibility_score_E": -90.0 + } + }, + "sigir-20153": { + "NCT01326507": { + "relevance_explanation": "The patient presents with symptoms suggestive of a pulmonary embolism, such as acute onset of shortness of breath, tachypnea, and chest pain, which are relevant to the trial's focus on acute pulmonary embolism. However, there is no confirmed diagnosis of pulmonary embolism in the emergency department, which is a key inclusion criterion for the trial. Therefore, while the symptoms align with the trial's target condition, the lack of a confirmed diagnosis reduces the relevance.", + "relevance_score_R": 70.0, + "eligibility_explanation": "The patient shows symptoms that suggest a pulmonary embolism, but there is no confirmed diagnosis, which is necessary for inclusion. The patient is not excluded by any of the exclusion criteria, such as being under guardianship, lacking social insurance, being pregnant, refusing consent, or having a recent myocardial infarction. However, without a confirmed diagnosis of pulmonary embolism, the patient cannot be considered eligible for the trial.", + "eligibility_score_E": 0.0 + }, + "NCT01139632": { + "relevance_explanation": "The patient is relevant to the clinical trial as he presents with chest pain, which may indicate an intermediate risk for coronary artery disease (CAD), a key focus of the trial. Additionally, he is 65 years old, which meets the age criterion, and he is able to provide informed consent. However, there is no mention of nonalcoholic fatty liver disease (NAFLD), which is a primary target condition of the trial, slightly reducing the relevance.", + "relevance_score_R": 70.0, + "eligibility_explanation": "The patient meets several inclusion criteria: he is over 18 years old, can provide informed consent, and presents with chest pain, which may indicate an intermediate risk for CAD. However, there is insufficient information regarding stress tests, which are necessary to fully assess eligibility for some criteria. Additionally, there is no information on the presence of NAFLD, which is a key condition for the trial. The patient is not excluded based on the available exclusion criteria, but the lack of information on NAFLD and stress tests limits full eligibility.", + "eligibility_score_E": 30.0 + } + }, + "sigir-20154": { + "NCT00844987": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as she presents with an acute coronary syndrome (ACS), evidenced by typical chest pain, ST-segment elevation on ECG, and elevated cardiac biomarkers (CK-MB and Troponin T). These are key inclusion criteria for the trial, which aims to study growth factors in patients with ACS. Additionally, the patient underwent coronary angiography, which aligns with the trial's protocol for assessing myocardial injury.", + "relevance_score_R": 95.0, + "eligibility_explanation": "The patient meets all the inclusion criteria: she experienced typical chest pain, has ST-segment elevation on ECG, underwent coronary angiography, and will provide informed consent. She does not have a known past history of myocardial infarction, which is an exclusion criterion, and she will sign informed consent, fulfilling all necessary conditions for participation. Therefore, she is fully eligible for the trial.", + "eligibility_score_E": 95.0 + }, + "NCT01243255": { + "relevance_explanation": "The patient is relevant to the clinical trial because she has hypercholesterolemia, which is the target condition of the trial. However, there is no information provided about whether she is currently on lipid-lowering drug treatment, which is a key inclusion criterion for the trial. This lack of information reduces the relevance score.", + "relevance_score_R": 50.0, + "eligibility_explanation": "The eligibility of the patient is uncertain due to the lack of information regarding her current treatment for hypercholesterolemia. There is no evidence that she is on lipid-lowering therapy, which is required for inclusion. Additionally, there is no information about the duration of any such treatment or changes in medication, which are also important criteria. The patient is not excluded based on the available exclusion criteria, as she will provide informed consent. However, the absence of information about a recent blood sample for lipid profile and glucose further complicates the eligibility assessment.", + "eligibility_score_E": 0.0 + } + }, + "sigir-20155": { + "NCT02407106": { + "relevance_explanation": "The clinical trial is focused on children with a history of rheumatic fever, specifically targeting the prevention of streptococcal throat infections in this population. The patient is a 31-year-old woman with no previous medical problems and no history of rheumatic fever or rheumatic heart disease. Therefore, the trial is not relevant to her condition as it is designed for a pediatric population with a specific medical history that she does not have.", + "relevance_score_R": 10.0, + "eligibility_explanation": "The patient does not meet the inclusion criteria as she does not have rheumatic heart disease or a history of rheumatic fever, which are necessary for participation in the trial. Additionally, the trial is aimed at children, and the patient is an adult. While she is willing to comply with the trial protocol, this does not affect her eligibility given the lack of relevant medical history and age mismatch.", + "eligibility_score_E": -10.0 + }, + "NCT02118818": { + "relevance_explanation": "The patient presents with symptoms such as joint pain, fever, and chest pain, which could be indicative of rheumatic fever, a precursor to rheumatic heart disease (RHD). However, there is no direct mention of rheumatic heart disease or any echocardiographic evidence of RHD in the patient note. The trial is focused on the genetics of RHD, and without confirmed RHD, the relevance is limited.", + "relevance_score_R": 30.0, + "eligibility_explanation": "The patient does not meet the inclusion criterion of having clinical and echocardiographic signs of RHD, as there is no mention of such signs in the patient note. Additionally, the patient is not excluded based on the absence of congenital heart disease. However, the lack of confirmed RHD makes the patient ineligible for the trial.", + "eligibility_score_E": -30.0 + } + }, + "sigir-20156": { + "NCT02375451": { + "relevance_explanation": "The patient presents with symptoms consistent with hyperthyroidism, which is one of the target conditions of the clinical trial. However, the trial is specifically focused on the effects of radioiodine therapy on salivary function in children, and the patient is an adult. Additionally, there is no mention of the patient having received radioiodine therapy, which is a key aspect of the trial. Therefore, while the patient's condition is relevant, the specific focus of the trial on pediatric patients and radioiodine therapy limits the relevance.", + "relevance_score_R": 30.0, + "eligibility_explanation": "The patient does not meet the inclusion criteria as there is no evidence of having received radioiodine therapy, nor is there information to suggest she is part of a negative control group. She is not excluded based on language, as she can provide informed consent. However, the trial's focus on pediatric patients further limits her eligibility.", + "eligibility_score_E": -30.0 + }, + "NCT01717352": { + "relevance_explanation": "The patient is relevant to the clinical trial as she is within the age range of 21 to 65 years, which is one of the inclusion criteria. Additionally, her symptoms of insomnia suggest she may sleep 7 hours or less most nights, aligning with another inclusion criterion. However, there is no information about her BMI, which is crucial for determining relevance to a weight loss study targeting overweight or obese individuals.", + "relevance_score_R": 60.0, + "eligibility_explanation": "The patient meets the age criterion and likely meets the sleep criterion due to her insomnia. However, there is insufficient information about her BMI, which is necessary to confirm her eligibility for a study focused on overweight or obese individuals. Additionally, there is no information on exclusion criteria such as the use of medications affecting sleep, sleep apnea, or shift work, which could impact her eligibility.", + "eligibility_score_E": 20.0 + } + }, + "sigir-20157": { + "NCT02633449": { + "relevance_explanation": "The patient presents with symptoms consistent with depression, such as fatigue, increased sleep and appetite, difficulty concentrating, anhedonia, and feelings of guilt. These symptoms align with the target condition of major depression for the clinical trial. However, there is no explicit diagnosis of unipolar major depressive disorder, which is a key inclusion criterion. Despite this, the symptoms suggest a high likelihood of relevance to the trial's focus on depression treatment.", + "relevance_score_R": 75.0, + "eligibility_explanation": "The patient does not have any exclusionary conditions such as neurological diseases, manic episodes, psychotic symptoms, recent psychotherapy, or electroconvulsive therapy. However, the lack of a confirmed diagnosis of unipolar major depressive disorder limits full eligibility. Additionally, there is no information on current medication, which could potentially affect eligibility if the patient is on medications other than SSRIs or Mirtazapine. Therefore, while the patient is not excluded by any criteria, the absence of a confirmed diagnosis and medication information results in partial eligibility.", + "eligibility_score_E": 50.0 + }, + "NCT01632319": { + "relevance_explanation": "The patient is a 20-year-old undergraduate college student, which aligns with the trial's target demographic of undergraduate students aged 18-24. She exhibits symptoms of depression, which is one of the target conditions of the trial. However, there is no information provided about her binge drinking behavior, which is a key component of the trial's focus. This lack of information on binge drinking reduces the relevance slightly, but her depressive symptoms and student status still make her a relevant candidate for the trial.", + "relevance_score_R": 70.0, + "eligibility_explanation": "The patient meets the inclusion criteria for age and student status. She shows symptoms of depression, but there is no BDI-II score provided to confirm the severity of her depression, which is necessary for full inclusion. Additionally, there is no information on her binge drinking behavior, which is a critical inclusion criterion. She does not meet any exclusion criteria, as there is no evidence of substance dependence, bulimia, psychosis, bipolar disorder, recent psychosocial treatment, or recent changes in antidepressant medication. Due to the lack of information on binge drinking and BDI-II score, her eligibility is limited.", + "eligibility_score_E": 20.0 + } + }, + "sigir-20158": { + "NCT00393913": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as he exhibits symptoms consistent with obstructive sleep apnea (OSA), such as nighttime snoring, pauses in breathing, and daytime sleepiness, which are key focus areas of the trial. The trial aims to evaluate the relationship between sleep-disordered breathing and daytime alertness, which aligns with the patient's symptoms.", + "relevance_score_R": 95.0, + "eligibility_explanation": "The patient meets the primary inclusion criterion by exhibiting symptoms of OSA, including snoring and daytime sleepiness. There is no information suggesting the presence of other sleep disorders, unstable medical conditions, or use of psychotropic medications, which are exclusion criteria. The patient is a 10-year-old boy, so pregnancy is not applicable, and he can provide informed consent, indicating no communication impairments. However, there is insufficient information regarding the patient's stable medical history and medication changes, which slightly affects the eligibility score.", + "eligibility_score_E": 85.0 + }, + "NCT02562040": { + "relevance_explanation": "The patient is relevant to the clinical trial as he exhibits symptoms of sleep-disordered breathing, such as nighttime snoring, pauses in breathing, and restlessness, which align with the trial's focus on evaluating adenotonsillectomy for children with sleep-disordered breathing. However, there is no direct evidence of a diagnosis of mild sleep-disordered breathing, and the frequency and duration of snoring are not specified, which limits the relevance.", + "relevance_score_R": 70.0, + "eligibility_explanation": "The patient shows potential eligibility as he is not excluded by any of the exclusion criteria provided. However, there is insufficient information to confirm eligibility for the inclusion criteria, such as the lack of a polysomnogram, tonsillar hypertrophy assessment, and ENT evaluation. Therefore, while the patient is not disqualified, there is not enough information to confirm full eligibility.", + "eligibility_score_E": 0.0 + } + }, + "sigir-20159": { + "NCT01766830": { + "relevance_explanation": "The patient is relevant to the clinical trial as they present with a persistent fever lasting more than one week, which aligns with the trial's focus on patients with persistent fevers in tropical regions. Additionally, the patient is within the age range specified by the trial's inclusion criteria.", + "relevance_score_R": 80.0, + "eligibility_explanation": "While the patient meets the inclusion criteria of having a fever for more than one week and being of eligible age, they are excluded due to the need for immediate intensive care as indicated by signs of respiratory distress. This exclusion criterion significantly impacts their eligibility for the trial.", + "eligibility_score_E": -80.0 + } + }, + "sigir-201510": { + "NCT02340533": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as she presents with symptoms that align with the target condition of adenomyosis, such as severe premenstrual and menstrual pelvic pain, heavy and irregular periods, and occasional spotting. These symptoms match the inclusion criteria of dysmenorrhea, chronic pelvic pain, menorrhagia, and metrorrhagia. Additionally, the patient is willing to provide informed consent and comply with the trial protocol, which is necessary for participation.", + "relevance_score_R": 95.0, + "eligibility_explanation": "The patient meets the inclusion criteria as she exhibits symptoms of dysmenorrhea, chronic pelvic pain, menorrhagia, and metrorrhagia, which are indicative of pelvic congestion and relevant to the study of adenomyosis. There are no exclusion criteria that apply to her, as she is willing to provide informed consent and comply with the trial protocol. Therefore, she is fully eligible for the trial.", + "eligibility_score_E": 95.0 + }, + "NCT01377519": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as she is a premenopausal woman experiencing symptoms that could be associated with uterine fibroids, such as severe pelvic pain and heavy, irregular periods. These symptoms align with the target condition of the trial, which is uterine fibroids.", + "relevance_score_R": 90.0, + "eligibility_explanation": "The patient meets several inclusion criteria: she is over 18, premenopausal, and has symptoms suggestive of fibroids. However, there is insufficient information regarding the accessibility of fibroids for treatment and her hematocrit level. Importantly, she is excluded due to unexplained menstrual irregularity, which is a specific exclusion criterion. This significantly impacts her eligibility.", + "eligibility_score_E": -45.0 + } + }, + "sigir-201511": { + "NCT01862510": { + "relevance_explanation": "The patient exhibits symptoms consistent with hypothyroidism, such as cold sensitivity, fatigue, hyporeflexia, and dry skin, which are relevant to the trial's focus on hypothyroid patients. However, there is no explicit mention of a formal diagnosis of hypothyroidism or the use of thyroid replacement therapy, which are key inclusion criteria for the trial. This limits the relevance but does not eliminate it entirely, as the symptoms strongly suggest the possibility of hypothyroidism.", + "relevance_score_R": 60.0, + "eligibility_explanation": "The patient shows symptoms indicative of hypothyroidism, which aligns with the trial's inclusion criteria. However, there is no confirmation of a hypothyroidism diagnosis or the use of thyroid replacement therapy, which are necessary for inclusion. On the exclusion side, there is no evidence of any disqualifying treatments or procedures, such as thyroid surgery or specific medications. Therefore, while the patient is not explicitly excluded, the lack of confirmed inclusion criteria limits eligibility.", + "eligibility_score_E": 20.0 + }, + "NCT01197183": { + "relevance_explanation": "The patient exhibits symptoms consistent with hypothyroidism, such as cold sensitivity, fatigue, constipation, hyporeflexia, and dry skin, which aligns with the target condition of the trial. However, there is no direct evidence of a recent diagnosis of hypothyroidism, which is a key inclusion criterion. The patient is willing to provide informed consent and comply with the trial protocol, which is relevant for participation. Overall, the patient is relevant to the trial due to the symptomatic presentation, but the lack of a confirmed recent diagnosis reduces the relevance.", + "relevance_score_R": 70.0, + "eligibility_explanation": "The patient meets the inclusion criterion of providing informed consent and does not meet any exclusion criteria, such as recent participation in another clinical trial or inability to follow up. However, the lack of information regarding a recent diagnosis of hypothyroidism and contraindications to L\u00e9vothyrox limits the eligibility. Therefore, while the patient is not excluded, the eligibility is not fully confirmed due to missing diagnostic information.", + "eligibility_score_E": 30.0 + } + }, + "sigir-201512": { + "NCT02418169": { + "relevance_explanation": "The patient is relevant to the clinical trial as he has sustained a skull fracture, which is one of the target conditions of the study. The trial aims to evaluate the association between traumatic brain injuries and skull fractures, and the patient fits this profile. However, there is no information about a craniofacial fracture or the Glasgow Coma Scale (GCS) score, which limits the relevance slightly.", + "relevance_score_R": 80.0, + "eligibility_explanation": "The patient meets the inclusion criterion of having a skull fracture, which is relevant to the study's focus on craniofacial and skull fractures. There is no exclusion criterion that applies to the patient, as he was admitted to the hospital and did not die before admission. However, the lack of information on the GCS score means we cannot fully confirm eligibility based on the severe traumatic brain injury criterion.", + "eligibility_score_E": 60.0 + }, + "NCT02467309": { + "relevance_explanation": "The patient presents with symptoms consistent with bacterial meningitis, such as fever and nuchal rigidity, which are relevant to the trial's focus on bacterial meningitis. However, the trial is specifically targeting children, and the patient is an adult, which significantly reduces the relevance.", + "relevance_score_R": 20.0, + "eligibility_explanation": "The patient shows clinical signs of probable bacterial meningitis but lacks cerebrospinal fluid examination results to confirm the diagnosis. Additionally, the trial is for children, and the patient is an adult, making him ineligible.", + "eligibility_score_E": 0.0 + } + }, + "sigir-201513": { + "NCT00315042": { + "relevance_explanation": "The patient is a 5-year-old boy presenting with symptoms such as dysphagia, drooling, fever, and vocal changes, which are consistent with pharyngitis. The trial targets children aged 6 months to less than 13 years with Streptococcus pyogenes tonsillitis/pharyngitis. However, there is no specific mention of Streptococcus pyogenes infection in the patient note, which is a key requirement for the trial. Despite this, the age and some symptoms align with the trial's focus, making the patient somewhat relevant.", + "relevance_score_R": 60.0, + "eligibility_explanation": "The patient meets the age criterion and presents with symptoms like fever and pain on swallowing, which are part of the inclusion criteria. However, there is no confirmation of a Streptococcus pyogenes infection through a rapid detection test, which is crucial for eligibility. Additionally, the patient's symptoms suggest possible epiglottitis, an exclusion criterion, which disqualifies him from the trial. Therefore, despite meeting some inclusion criteria, the exclusion criterion related to deep tissue infection makes the patient ineligible.", + "eligibility_score_E": -60.0 + }, + "NCT01255670": { + "relevance_explanation": "The clinical trial is focused on the treatment of peritonsillar abscess in adults, while the patient is a 5-year-old boy with symptoms that could suggest a peritonsillar abscess but without a confirmed diagnosis. Additionally, the trial is specifically for adult patients, which makes the patient less relevant to this trial.", + "relevance_score_R": 20.0, + "eligibility_explanation": "The patient does not meet the age requirement as the trial is for adults. There is no confirmed diagnosis of peritonsillar abscess, which is a key inclusion criterion. While the patient is voluntary, other criteria such as language skills, email access, and confirmed diagnosis are not met. The patient is not excluded by any criteria, but the lack of inclusion criteria fulfillment makes him ineligible.", + "eligibility_score_E": -20.0 + } + }, + "sigir-201514": { + "NCT00827463": { + "relevance_explanation": "The patient is a pregnant woman at 11 weeks gestation, which aligns with the trial's focus on early detection of anemia during the first trimester of pregnancy. Her condition of anemia is directly relevant to the trial's target condition.", + "relevance_score_R": 90.0, + "eligibility_explanation": "The patient meets the inclusion criterion as she is at the beginning of her pregnancy. However, she is excluded due to receiving iron supplementation, which could be considered a periconceptional treatment against anemia. There is no information on whether she speaks French, but this does not affect the current eligibility assessment.", + "eligibility_score_E": -90.0 + }, + "NCT01308112": { + "relevance_explanation": "The patient is a 27-year-old pregnant woman at 11 weeks gestation, which fits the inclusion criteria for age and gestational period. The trial focuses on prenatal iron supplementation, and the patient is already receiving iron supplements due to mild iron deficiency. This makes her relevant to the study, which aims to compare iron supplementation methods in pregnant women.", + "relevance_score_R": 90.0, + "eligibility_explanation": "The patient meets the inclusion criteria of being a woman aged 15-45 and being pregnant with a gestational age of less than 23 weeks. She is not excluded by the criteria of failing to provide a blood sample, having an initial hemoglobin concentration below 90 g/L, or carrying multiples. She will provide informed consent, which is required. There is no evidence of sickle cell anemia, epilepsy, diabetes, eclampsia, pre-eclampsia, mental retardation, or a metabolic disorder. However, there is insufficient information regarding her plans to deliver outside the research clinic or leave the homestead, which could potentially affect her eligibility. Despite these uncertainties, the available information suggests she is likely eligible.", + "eligibility_score_E": 70.0 + } + }, + "sigir-201515": { + "NCT00932425": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as she has experienced a cryptogenic stroke, which is the target condition of the trial. Additionally, she is over 18 years old and had the stroke within the last 60 days, both of which are inclusion criteria for the trial. However, there is no information indicating that she was seen at UCSF Medical Center, which is a specific requirement for the trial.", + "relevance_score_R": 80.0, + "eligibility_explanation": "The patient meets the age and recent stroke onset inclusion criteria and does not meet any of the exclusion criteria based on the available information. However, there is a lack of information regarding whether she was seen at UCSF Medical Center, which is a critical inclusion criterion. This missing information affects her eligibility status.", + "eligibility_score_E": 40.0 + }, + "NCT01550588": { + "relevance_explanation": "The patient is relevant to the clinical trial as she has experienced a cryptogenic stroke within the last three months, which is a key inclusion criterion. However, the trial specifically targets patients with a high-risk Patent Foramen Ovale (PFO), which has not been diagnosed in this patient. This lack of a PFO diagnosis reduces the relevance of the trial to the patient, as the primary objective of the trial is to assess treatment strategies for cryptogenic stroke patients with high-risk PFO.", + "relevance_score_R": 50.0, + "eligibility_explanation": "The patient meets several inclusion criteria: she had a cryptogenic stroke within the last three months, is willing to participate in follow-up visits, and there are no other potential causes of stroke identified. She also does not meet any exclusion criteria. However, the patient does not meet the critical inclusion criterion of having a high-risk PFO, which is essential for trial eligibility. This significantly impacts her eligibility for the trial.", + "eligibility_score_E": 0.0 + } + }, + "sigir-201516": { + "NCT00839124": { + "relevance_explanation": "The clinical trial is focused on individuals with allergic asthma or normal volunteers. The patient is a 4-year-old boy with a history of allergic rhinitis and a recent episode of wheezing, which could suggest a potential for asthma. However, the trial specifically requires a history of episodic wheezing or asthma diagnosis after the age of 6, which the patient does not meet. Additionally, the trial involves an inhalational challenge, which may not be suitable for a child of this age. Therefore, the relevance is low as the patient does not fit the primary target group of the study.", + "relevance_score_R": 20.0, + "eligibility_explanation": "The patient does not meet the inclusion criteria for a history of wheezing or asthma diagnosis after age 6. There is no information on lung function tests, methacholine challenge, or allergy skin tests, which are critical for eligibility. The patient does not meet any exclusion criteria, but the lack of meeting key inclusion criteria makes him ineligible for the trial.", + "eligibility_score_E": -20.0 + }, + "NCT00930826": { + "relevance_explanation": "The clinical trial is focused on bronchial asthma, a condition the patient does not have a clinical diagnosis for. The patient presented with wheezing for the first time and has no history of asthma, which makes the trial less relevant to him. The trial requires participants to have a clinical diagnosis of bronchial asthma, which the patient does not meet.", + "relevance_score_R": 20.0, + "eligibility_explanation": "The patient does not meet the primary inclusion criterion of having a clinical diagnosis of bronchial asthma. There is also insufficient information regarding the patient's ability to swallow tablets, which is another inclusion criterion. However, the patient is not excluded based on the exclusion criterion related to steroid use, as there is no mention of steroid inhalation or ingestion in the patient note.", + "eligibility_score_E": -20.0 + } + }, + "sigir-201517": { + "NCT01446198": { + "relevance_explanation": "The patient is relevant to the clinical trial because she has tested positive for HPV, which is the target condition of the trial. However, the patient note does not provide specific information about the APTIMA HPV Assay or the PANTHER System, which are central to the trial's objectives.", + "relevance_score_R": 60.0, + "eligibility_explanation": "The eligibility of the patient cannot be fully determined due to lack of specific information. The patient note does not confirm if the sample had an APTIMA HPV Assay TIGRIS System result, if an aliquot is available and suitable for testing, or if the sample was randomly selected. Additionally, there is no information on the integrity of the sample. Therefore, while the patient is relevant, her eligibility remains uncertain.", + "eligibility_score_E": 0.0 + }, + "NCT01231945": { + "relevance_explanation": "The patient is relevant to the clinical trial as she is a 32-year-old female, which fits the age and gender criteria for the study. She has tested positive for HPV, which is a key focus of the trial. The trial aims to evaluate HPV testing methods, and the patient has a recent HPV positive result, making her a suitable candidate for the study.", + "relevance_score_R": 90.0, + "eligibility_explanation": "The patient meets several inclusion criteria: she has not been previously diagnosed with cervical cancer, is female and likely has a cervix, and is physically able to undergo routine cervical cancer screening. She can provide informed consent. There is no information about her pregnancy status, which is a potential exclusion criterion, but not enough to disqualify her without further information. The lack of information on her pregnancy status slightly reduces her eligibility score.", + "eligibility_score_E": 70.0 + } + }, + "sigir-201518": { + "NCT00344513": { + "relevance_explanation": "The patient exhibits significant symptoms of heart failure, such as shortness of breath on exertion, orthopnea, bibasilar lung crackles, pitting edema, and jugular venous distension, which are relevant to the trial's focus on heart failure. However, there is no information about the patient being hospitalized, which is a key component of the trial's inclusion criteria.", + "relevance_score_R": 70.0, + "eligibility_explanation": "While the patient shows symptoms consistent with heart failure, there is no information confirming hospitalization for heart failure, which is necessary for inclusion. Additionally, there is no data on systolic or diastolic dysfunction, which is required to meet the inclusion criteria. The absence of exclusion criteria does not impact eligibility negatively.", + "eligibility_score_E": 0.0 + }, + "NCT00534066": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as he presents with symptoms consistent with congestive heart failure (CHF), which is the target condition of the trial. The trial aims to study patients with CHF in the Emergency Department, and the patient's symptoms such as shortness of breath, difficulty breathing when lying flat, lung crackles, and edema are indicative of CHF. However, there is no explicit mention of a primary diagnosis of CHF in the Emergency Department, which slightly reduces the relevance.", + "relevance_score_R": 80.0, + "eligibility_explanation": "The patient meets the age criterion and is able to provide informed consent, which are positive indicators for eligibility. However, there is insufficient information to confirm a primary diagnosis of CHF in the Emergency Department, which is a crucial inclusion criterion. Additionally, there is no information on hospital admission or transfer to the Observation Unit, which is another inclusion criterion. The patient does not meet any exclusion criteria based on the available information, but the lack of confirmation on key inclusion criteria limits the eligibility.", + "eligibility_score_E": 20.0 + } + }, + "sigir-201519": { + "NCT00806091": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as she has a significant smoking history and presents with symptoms consistent with COPD, which is the target condition of the trial. The trial aims to study the effects of smoking on COPD, making her a suitable candidate for the research focus.", + "relevance_score_R": 95.0, + "eligibility_explanation": "The patient meets the inclusion criterion of being a smoker with COPD, as evidenced by her significant smoking history and symptoms indicative of COPD. She does not meet the criterion for non-smokers, but this does not affect her eligibility since she qualifies under the smoker category. There are no exclusion criteria mentioned that would disqualify her.", + "eligibility_score_E": 95.0 + }, + "NCT02213809": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as she presents with symptoms and a history consistent with COPD, which is the target condition of the trial. Her significant smoking history and chronic respiratory symptoms strongly suggest COPD, which aligns with the trial's focus on patients with this condition. However, there is no explicit confirmation of a COPD diagnosis or spirometry results indicating GOLD grade 2-3, which are necessary for full relevance.", + "relevance_score_R": 75.0, + "eligibility_explanation": "The patient likely has COPD due to her smoking history and symptoms, but there is no direct evidence of a COPD diagnosis or spirometry results indicating GOLD grade 2-3, which are required for eligibility. Without this information, we cannot confirm her eligibility for the trial.", + "eligibility_score_E": 0.0 + } + }, + "sigir-201520": { + "NCT00880347": { + "relevance_explanation": "The patient is relevant to the clinical trial as he is an 89-year-old male with significant cognitive impairment, which aligns with the trial's focus on Alzheimer's Disease and other types of dementia. The trial aims to study blood-based signatures in patients with probable Alzheimer's Disease or other dementias, and the patient's symptoms and age make him a suitable candidate for this research.", + "relevance_score_R": 80.0, + "eligibility_explanation": "The patient meets several inclusion criteria, such as being over 40 years old, providing informed consent, and being compliant with study procedures. However, there is no direct evidence of a clinical diagnosis of probable Alzheimer's Disease according to the specified criteria, and there is no evidence of brain imaging to confirm the diagnosis. Additionally, the presence of paratonic rigidity and myoclonic jerks may suggest other conditions, which could exclude him from the AD group. The patient is excluded from the non-AD demented group due to symptoms that may lead to reconsider the initial diagnosis of dementia. These factors significantly impact his eligibility.", + "eligibility_score_E": -40.0 + }, + "NCT00182832": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as he is an older adult with cognitive impairment, which is the target condition of the study. The trial aims to improve care for hospitalized older adults with memory problems, and the patient exhibits significant cognitive impairment symptoms. However, there is no explicit mention of the patient being hospitalized in a medical ward, which is a key inclusion criterion.", + "relevance_score_R": 80.0, + "eligibility_explanation": "The patient meets several inclusion criteria: he is over 65 years old, can speak English, and has cognitive impairment. There is no information suggesting he is excluded based on the exclusion criteria. However, the lack of explicit information about his hospitalization status in a medical ward limits his eligibility. Therefore, while he is relevant, his eligibility is uncertain due to this missing information.", + "eligibility_score_E": 40.0 + } + }, + "sigir-201521": { + "NCT02105714": { + "relevance_explanation": "The patient is relevant to the clinical trial as he presents with symptoms consistent with persistent digestive disorders, specifically diarrhea and abdominal cramping, which are target conditions of the trial. Additionally, the presence of ellipsoidal cysts in the stool suggests a parasitic infection, potentially giardiasis, which is one of the target conditions of the trial. However, the duration of the diarrhea is not specified, which is a critical factor for full relevance.", + "relevance_score_R": 70.0, + "eligibility_explanation": "The patient meets the inclusion criterion of providing informed consent and does not meet any exclusion criteria, such as needing immediate intensive care or having clinical jaundice. However, the lack of information on the duration of diarrhea prevents full eligibility, as persistent diarrhea is defined as lasting for at least 2 weeks. Therefore, while the patient is not excluded, he cannot be fully confirmed as eligible without additional information on the duration of symptoms.", + "eligibility_score_E": 35.0 + }, + "NCT01959048": { + "relevance_explanation": "The patient is not relevant to the clinical trial as there is no indication of Clostridium difficile infection. The symptoms and stool analysis suggest a Giardia infection, which is unrelated to the trial's focus on severe CDAD. The trial is specifically targeting patients with confirmed severe CDAD, which the patient does not have.", + "relevance_score_R": 10.0, + "eligibility_explanation": "The patient is ineligible for the trial because he does not have a confirmed diagnosis of severe CDAD, which is a primary inclusion criterion. Additionally, the presence of an alternative etiology for diarrhea (likely Giardia) excludes him from participation. While the patient meets some general inclusion criteria such as age and ability to consent, these are insufficient without the primary condition of interest.", + "eligibility_score_E": -10.0 + } + }, + "sigir-201522": { + "NCT02534727": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as he has a history of tuberculosis and ongoing symptoms of pulmonary TB, which are key target conditions of the trial. The trial aims to study the pharmacokinetics of TB drugs, and the patient is likely to be Mycobacterium culture positive, which aligns with the trial's objectives.", + "relevance_score_R": 90.0, + "eligibility_explanation": "The patient meets most of the inclusion criteria: he is over 18, has a history of TB, shows ongoing symptoms, is likely Mycobacterium culture positive, and is willing to comply with the trial protocol. However, there is no information on whether he is taking anti-tuberculosis medicines or if there is suspected drug resistance, which are important criteria for full eligibility. There are no exclusion criteria that apply to him.", + "eligibility_score_E": 60.0 + }, + "NCT01207128": { + "relevance_explanation": "The patient is relevant to the clinical trial as he has a diagnosis of aspergillosis, which is the target condition of the trial. The presence of septated, low-angle branching hyphae in the sputum culture is indicative of Aspergillus species, aligning with the trial's focus on invasive aspergillosis. Additionally, the patient is willing to provide informed consent and is over 18 years of age, meeting some of the basic inclusion criteria.", + "relevance_score_R": 80.0, + "eligibility_explanation": "The patient meets the inclusion criteria of providing informed consent and being over 18 years old. However, there is insufficient information regarding the Aspergillus GM index, which is crucial for confirming the diagnosis of invasive aspergillosis as per the trial's requirements. Additionally, there is no information on prior antifungal treatment duration, liver function tests, creatinine levels, or any other exclusion criteria that might disqualify the patient. Therefore, while the patient is not explicitly excluded, the lack of information on key eligibility criteria limits the ability to confirm full eligibility.", + "eligibility_score_E": 20.0 + } + }, + "sigir-201523": { + "NCT00084240": { + "relevance_explanation": "The patient presents with symptoms consistent with uncomplicated, symptomatic malaria, such as high fever and joint pain, which aligns with the trial's target condition of uncomplicated, symptomatic falciparum malaria. However, there is no confirmation of a positive blood smear or rapid diagnostic test for Plasmodium falciparum, which are critical for confirming relevance to the trial.", + "relevance_score_R": 60.0, + "eligibility_explanation": "The patient is excluded due to the presence of leukopenia and thrombocytopenia, which are considered blood dyscrasias and are listed as exclusion criteria. Additionally, there is insufficient information to confirm the inclusion criteria, such as a positive blood smear or rapid diagnostic test for P. falciparum, and serum glucose levels.", + "eligibility_score_E": -60.0 + }, + "NCT02334514": { + "relevance_explanation": "The patient presents with symptoms such as sudden onset of high fever, headache, and joint pain, which are suggestive of influenza virus infection. These symptoms align with the clinical presentation required for the trial, making the patient relevant to the study. However, there is no confirmation of influenza via a PCR test, which is crucial for full relevance.", + "relevance_score_R": 70.0, + "eligibility_explanation": "The patient meets the symptom-based inclusion criterion, suggesting potential influenza infection. However, there is no information on a positive PCR test for influenza or whether antiviral treatment was indicated, which are necessary for full eligibility. The patient does not meet any exclusion criteria, as he is not immune compromised, not pregnant, and there is no information on prior oseltamivir treatment. Therefore, the eligibility is limited by the lack of PCR confirmation and treatment indication.", + "eligibility_score_E": 20.0 + } + }, + "sigir-201524": { + "NCT00540072": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as he presents with symptoms consistent with community-acquired bacterial pneumonia, which is the target condition of the trial. The patient exhibits a productive cough, fever, and chest pain, which align with the clinical symptoms required for the trial. Additionally, he is willing to provide informed consent and comply with the trial protocol.", + "relevance_score_R": 90.0, + "eligibility_explanation": "The patient meets several inclusion criteria, such as being an adult male, having a productive cough, and exhibiting fever. However, there is insufficient information regarding a chest radiograph showing a new pulmonary infiltrate, which is a critical inclusion criterion. Additionally, there is no information on the patient's white blood cell count or hypoxemia status, which are also important for eligibility. The patient does not meet any exclusion criteria based on the available information.", + "eligibility_score_E": 45.0 + }, + "NCT00711399": { + "relevance_explanation": "The patient is highly relevant to the clinical trial as he presents with respiratory symptoms, specifically a productive cough and wheezing, which are key conditions being studied in the trial. The trial aims to assess respiratory sounds, and the patient's symptoms align well with the trial's focus. Additionally, the patient is willing to provide informed consent and comply with the trial protocol, further supporting his relevance.", + "relevance_score_R": 95.0, + "eligibility_explanation": "The patient meets all the inclusion criteria: he has a productive cough and is willing to provide informed consent. He does not meet any of the exclusion criteria: he does not have chest tubes, there are no skin lesions mentioned that would preclude sensor attachment, he is not in respiratory distress, and as a male, pregnancy is not applicable. Therefore, the patient is fully eligible for the trial.", + "eligibility_score_E": 95.0 + } + } +} \ No newline at end of file diff --git a/results/matching_results_sigir_gpt-4o.json b/results/matching_results_sigir_gpt-4o.json new file mode 100644 index 0000000..b8aea3c --- /dev/null +++ b/results/matching_results_sigir_gpt-4o.json @@ -0,0 +1,7108 @@ +{ + "sigir-20141": { + "0": { + "NCT01397994": { + "inclusion": { + "0": [ + "The patient has episodic chest pain but no evidence of chronic stable angina or abnormal Exercise Myocardial Perfusion Spect Scan.", + [ + 0, + 1 + ], + "not included" + ], + "1": [ + "The patient is female.", + [ + 0 + ], + "included" + ], + "2": [ + "The patient is 58 years old, which is within the age range.", + [ + 0 + ], + "included" + ], + "3": [ + "The patient is willing and able to comply with study procedures.", + [ + 8 + ], + "included" + ], + "4": [ + "The patient will provide informed consent.", + [ + 8 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient has hypertension, but no specific blood pressure values are provided.", + [ + 3 + ], + "not enough information" + ], + "1": [ + "There is no mention of valvular heart disease or cardiomyopathy.", + [], + "not excluded" + ], + "2": [ + "There is no mention of a myocardial infarction in the past 6 months.", + [], + "not excluded" + ], + "3": [ + "The patient presents with episodic chest pain, but it is not specified as unstable angina.", + [ + 0, + 1 + ], + "not enough information" + ], + "4": [ + "There is no mention of congestive cardiac failure.", + [], + "not excluded" + ], + "5": [ + "There is no mention of severe anemia or hemoglobin levels.", + [], + "not enough information" + ], + "6": [ + "There is no mention of cardiac arrhythmias or AV block.", + [], + "not excluded" + ], + "7": [ + "There is no mention of liver or renal dysfunction.", + [], + "not excluded" + ], + "8": [ + "The patient denies having diabetes.", + [ + 4 + ], + "not excluded" + ], + "9": [ + "There is no mention of systolic blood pressure being less than 100 mm Hg.", + [], + "not excluded" + ], + "10": [ + "The patient is not pregnant or nursing.", + [ + 0 + ], + "not excluded" + ], + "11": [ + "There is no mention of hypersensitivity to nicorandil.", + [], + "not excluded" + ], + "12": [ + "The patient is not on calcium channel blockers.", + [ + 5 + ], + "not excluded" + ], + "13": [ + "There is no mention of eligibility for Tc 99m SPECT.", + [], + "not enough information" + ], + "14": [ + "There is no mention of contraindications to beta blockers.", + [], + "not excluded" + ], + "15": [ + "The patient has no geographical inaccessibility for treatment or follow-up.", + [ + 8 + ], + "not excluded" + ] + } + }, + "NCT00149227": { + "inclusion": { + "0": [ + "The patient has a clinical diagnosis of hypertension.", + [ + 3 + ], + "included" + ], + "1": [ + "The patient has obesity and ECG abnormality, which are risk factors.", + [ + 3, + 7 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient is not currently taking any medications, including ARBs.", + [ + 5 + ], + "not excluded" + ], + "1": [ + "There is no mention of the patient having undergone PCI or CABG.", + [], + "not enough information" + ], + "2": [ + "The patient has hypertension but there is no indication it is severe/malignant/secondary.", + [ + 3 + ], + "not excluded" + ], + "3": [ + "The patient is a 58-year-old woman, but there is no mention of pregnancy or childbearing potential.", + [ + 0 + ], + "not enough information" + ], + "4": [ + "There is no history of heart failure, unstable angina, myocardial infarction, PTCA, or CABG within the preceding 6 months mentioned.", + [], + "not excluded" + ], + "5": [ + "There is no mention of arrhythmia or AV block.", + [], + "not enough information" + ], + "6": [ + "There is no information on renal impairment or serum creatinine levels.", + [], + "not enough information" + ], + "7": [ + "There is no information on hepatic impairment.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-20142": { + "0": { + "NCT00711399": { + "inclusion": { + "0": [ + "The patient will provide informed consent.", + [ + 6 + ], + "included" + ], + "1": [ + "The patient has cough and shortness of breath.", + [ + 0 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "No mention of chest tubes in the patient note.", + [], + "not excluded" + ], + "1": [ + "No mention of skin lesions in the patient note.", + [], + "not excluded" + ], + "2": [ + "The patient is in respiratory distress.", + [ + 4 + ], + "excluded" + ], + "3": [ + "The patient is an 8-year-old male, not applicable to pregnancy.", + [], + "not applicable" + ] + } + }, + "NCT02618655": { + "inclusion": { + "0": [ + "The patient has had a fever for 2 days, not more than one week.", + [ + 0 + ], + "not included" + ], + "1": [ + "The patient's temperature is higher than 38\u2103.", + [ + 0 + ], + "included" + ], + "2": [ + "There is no information about examinations after one week.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient has an infectious disease, not a non-infectious disease like rheumatic autoimmune disease or tumor.", + [ + 0, + 5 + ], + "not excluded" + ], + "1": [ + "The patient note does not provide information about the observation period or selection criteria.", + [], + "not enough information" + ], + "2": [ + "There is no indication that the patient left with automatic discharge.", + [], + "not excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-20143": { + "0": { + "NCT02490059": { + "inclusion": { + "0": [ + "The patient has a left lung mass on chest x-ray, but no mention of a CT scan confirming a pulmonary nodule.", + [ + 0 + ], + "not enough information" + ], + "1": [ + "There is no information about the visibility of the nodule on standard-size bronchoscopy.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient will provide informed consent.", + [ + 3 + ], + "not excluded" + ] + } + }, + "NCT01452971": { + "inclusion": { + "0": [ + "The patient has a left lung mass, but there is no confirmation of lung cancer diagnosis.", + [ + 0 + ], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient is 58 years old.", + [ + 0 + ], + "not excluded" + ], + "1": [ + "The patient has a left lung mass, suggesting lung cancer.", + [ + 0 + ], + "not excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-20144": { + "0": { + "NCT02390596": { + "inclusion": { + "0": [ + "The patient meets the criteria for Kawasaki Disease with fever for 5 days and 4 of 5 main clinical signs.", + [ + 0, + 1, + 4 + ], + "included" + ], + "1": [ + "There is no information about the patient's response to standard therapy.", + [], + "not enough information" + ], + "2": [ + "The patient is 2 years old, which is likely above 5 kg.", + [ + 0 + ], + "included" + ], + "3": [ + "The patient will provide informed consent.", + [ + 5 + ], + "included" + ], + "4": [ + "There is no information about the patient's health insurance.", + [], + "not enough information" + ], + "5": [ + "There is no information about contraception agreement.", + [], + "not applicable" + ] + }, + "exclusion": { + "0": [ + "The patient is a 2-year-old boy, not a preterm, neonate, or pregnant.", + [ + 0 + ], + "not excluded" + ], + "1": [ + "The patient has symptoms consistent with Kawasaki disease, no other diagnosis is suspected.", + [ + 0, + 1 + ], + "not excluded" + ], + "2": [ + "No evidence of overt concomitant bacterial infection is present.", + [ + 3 + ], + "not excluded" + ], + "3": [ + "No mention of previous treatment with another biotherapy.", + [], + "not enough information" + ], + "4": [ + "No evidence of immunodeficiency or cancer.", + [], + "not enough information" + ], + "5": [ + "No mention of increased risk of TB infection.", + [], + "not enough information" + ], + "6": [ + "No evidence of recent or active TB infection.", + [], + "not enough information" + ], + "7": [ + "No mention of close contact with a TB patient.", + [], + "not enough information" + ], + "8": [ + "No mention of recent arrival from a high TB prevalence country.", + [], + "not enough information" + ], + "9": [ + "No chest radiograph results suggestive of TB are mentioned.", + [], + "not enough information" + ], + "10": [ + "The patient has elevated liver enzymes but no mention of end stage renal disease, diabetes, or neutropenia.", + [ + 2, + 3 + ], + "not enough information" + ], + "11": [ + "No mention of hypersensitivity to the active substance or excipients.", + [], + "not enough information" + ], + "12": [ + "No mention of participation in another biomedical research.", + [], + "not enough information" + ] + } + }, + "NCT00841789": { + "inclusion": { + "0": [ + "The patient is a 2-year-old male.", + [ + 0 + ], + "included" + ], + "1": [ + "The patient will provide informed consent.", + [ + 5 + ], + "included" + ], + "2": [ + "The patient presents with symptoms consistent with Kawasaki Disease.", + [ + 0, + 1, + 4 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient has elevated alanine aminotransferase and low albumin, which may be considered laboratory toxicities.", + [ + 3 + ], + "excluded" + ], + "1": [ + "The patient does not have a platelet count < 100,000/mm3 mentioned.", + [], + "not excluded" + ], + "2": [ + "The patient has a WBC count of 17,580/mm3, which is not < 3,000 cells/mm3.", + [ + 3 + ], + "not excluded" + ], + "3": [ + "The patient has mild normochromic, normocytic anemia, but no specific values for hemoglobin, hematocrit, or RBC count are provided.", + [ + 3 + ], + "not enough information" + ], + "4": [ + "There is no mention of the patient being enrolled in another investigational trial.", + [], + "not excluded" + ], + "5": [ + "The patient is a 2-year-old boy, not a female subject 12 years or older.", + [ + 0 + ], + "not applicable" + ], + "6": [ + "There is no mention of hypersensitivity to Enbrel or antibodies to etanercept.", + [], + "not enough information" + ], + "7": [ + "There is no mention of prior or concurrent cyclophosphamide therapy.", + [], + "not enough information" + ], + "8": [ + "There is no mention of prior treatment with TNF alpha antagonist or steroid within 48 hours prior to IVIG.", + [], + "not enough information" + ], + "9": [ + "There is no mention of concurrent sulfasalazine therapy.", + [], + "not enough information" + ], + "10": [ + "There is no mention of active severe infections within 4 weeks before screening.", + [], + "not enough information" + ], + "11": [ + "There is no mention of SLE, multiple sclerosis, transverse myelitis, optic neuritis, or chronic seizure disorder.", + [], + "not enough information" + ], + "12": [ + "There is no mention of known HIV-positive status or other immuno-suppressing diseases.", + [], + "not enough information" + ], + "13": [ + "There is no mention of mycobacterial disease or high risk factors for tuberculosis.", + [], + "not enough information" + ], + "14": [ + "There is no mention of untreated Lyme disease.", + [], + "not enough information" + ], + "15": [ + "There is no mention of severe comorbidities such as diabetes, CHF, MI, CVA, TIA, angina, hypertension, pulmonary disease, or cancer.", + [], + "not enough information" + ], + "16": [ + "The patient has an enlarged liver and elevated liver enzymes, which may suggest jaundice or liver issues.", + [ + 2, + 3 + ], + "excluded" + ], + "17": [ + "There is no mention of use of a live vaccine 30 days prior to or during the study.", + [], + "not enough information" + ], + "18": [ + "There is no mention of any condition judged by the physician to be detrimental.", + [], + "not enough information" + ], + "19": [ + "There is no mention of a history of non-compliance with other therapies.", + [], + "not enough information" + ], + "20": [ + "There is no mention of receiving immunosuppressive agents in the past three months.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-20145": { + "0": { + "NCT00163709": { + "inclusion": { + "0": [ + "The patient is over 40 years old, presents to the ED with shortness of breath, but there is no information about the triage category.", + [ + 0 + ], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient does not present with a traumatic cause of dyspnea, severe renal disease, cardiogenic shock, or early transfer to another hospital.", + [], + "not excluded" + ] + } + }, + "NCT01935141": { + "inclusion": { + "0": [ + "The patient presents with symptoms that could suggest a pulmonary embolism, such as shortness of breath and elevated D-dimer, but there is no direct mention of a referral for a CT pulmonary angiogram.", + [ + 0, + 5 + ], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "No mention of congestive heart failure in the patient note.", + [], + "not excluded" + ], + "1": [ + "No mention of supraventricular tachycardia in the patient note.", + [], + "not excluded" + ], + "2": [ + "No mention of contrast allergy in the patient note.", + [], + "not excluded" + ], + "3": [ + "The patient will provide informed consent.", + [ + 6 + ], + "not excluded" + ], + "4": [ + "No information about serum creatinine levels in the patient note.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-20146": { + "0": { + "NCT00015626": { + "inclusion": { + "0": [ + "The patient is obese with a BMI likely greater than 27.", + [ + 0 + ], + "included" + ], + "1": [ + "The patient note does not mention specific complications of insulin resistance.", + [], + "not enough information" + ], + "2": [ + "The patient note does not mention siblings or parents with insulin resistance.", + [], + "not enough information" + ], + "3": [ + "The patient note does not mention a family history of type II diabetes.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient is not critically ill and there is no mention of congestive heart failure, renal or liver insufficiency.", + [], + "not excluded" + ], + "1": [ + "The patient is willing to provide informed consent.", + [ + 4 + ], + "not excluded" + ], + "2": [ + "The patient is not compliant with her diabetes medication or exercise.", + [ + 1 + ], + "excluded" + ] + } + }, + "NCT02512159": { + "inclusion": { + "0": [ + "The patient has a painful skin lesion on the left lower leg, but there is no direct evidence it is due to diabetes mellitus, venous stasis, or arterial insufficiency.", + [ + 2, + 3 + ], + "not enough information" + ], + "1": [ + "The criterion is not relevant as it specifies both sexes are eligible.", + [], + "not applicable" + ], + "2": [ + "The patient is 64 years old, which is over 18.", + [ + 0 + ], + "included" + ], + "3": [ + "There is no information about the patient having basic laboratory tests at admission.", + [], + "not enough information" + ], + "4": [ + "The patient has diabetes mellitus, which is a comorbidity associated with the trial.", + [ + 0 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient is not described as hemodynamically unstable.", + [], + "not excluded" + ], + "1": [ + "There is no mention of septic shock in the patient note.", + [], + "not excluded" + ], + "2": [ + "The patient has a skin lesion but no mention of deep skin ulcers with exposed organs.", + [ + 2, + 3 + ], + "not excluded" + ], + "3": [ + "There is no mention of secondary cutaneous ulcer enteral fistula.", + [], + "not excluded" + ], + "4": [ + "The patient has a skin lesion but no mention of cancer tumors.", + [ + 2, + 3 + ], + "not excluded" + ], + "5": [ + "The lesion is oozing but no mention of active bleeding.", + [ + 3 + ], + "not excluded" + ], + "6": [ + "There is no mention of necrosis in the skin lesion.", + [], + "not excluded" + ], + "7": [ + "There is no mention of leishmania or insect bite.", + [], + "not excluded" + ], + "8": [ + "There is no mention of burns.", + [], + "not excluded" + ], + "9": [ + "The patient will provide informed consent.", + [ + 4 + ], + "not excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-20147": { + "0": { + "NCT01863628": { + "inclusion": { + "0": [ + "The patient note does not mention if the patient has a biological parent diagnosed with bipolar disorder.", + [], + "not enough information" + ], + "1": [ + "The patient exhibits depressive symptoms and hypomania/mania symptoms, but there is no information on the duration or the presence of a biological parent with bipolar disorder.", + [ + 0, + 1, + 2, + 3, + 4 + ], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient has a DSM-IV defined Axis I disorder, bipolar disorder.", + [ + 0 + ], + "excluded" + ], + "1": [ + "There is no mention of a serious general medical illness in the patient note.", + [], + "not excluded" + ], + "2": [ + "There is no mention of mental retardation in the patient note.", + [], + "not excluded" + ], + "3": [ + "The patient is not being treated with antipsychotic drugs.", + [ + 5 + ], + "not excluded" + ], + "4": [ + "There is no indication that the patient is unable to complete neuropsychological tests due to physical conditions.", + [], + "not excluded" + ], + "5": [ + "There is no mention of the patient being pregnant or lactating.", + [], + "not excluded" + ], + "6": [ + "The patient is not taking thyroxine or hormone therapy.", + [ + 5 + ], + "not excluded" + ] + } + }, + "NCT00845988": { + "inclusion": { + "0": [ + "The patient has a history of bipolar disorder.", + [ + 0 + ], + "included" + ], + "1": [ + "The patient's age is 26, which is within the required range.", + [ + 0 + ], + "included" + ], + "2": [ + "The patient will provide informed consent, but there is no information about syndromal remission state.", + [ + 6 + ], + "not enough information" + ], + "3": [ + "The patient is obese, but there is no information about weight gain after starting current antipsychotic.", + [ + 0 + ], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient does not have a diagnosis of eating disorder, substance abuse, or psychotic disorder mentioned.", + [], + "not excluded" + ], + "1": [ + "There is no mention of a history of neurological or medical illness other than bipolar disorder.", + [], + "not excluded" + ], + "2": [ + "The patient is not mentioned to be pregnant or breastfeeding.", + [], + "not excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-20148": { + "0": { + "NCT01519271": { + "inclusion": { + "0": [ + "The patient has severe cognitive deficits and memory dysfunction, not mild cognitive impairment.", + [ + 1 + ], + "not included" + ], + "1": [ + "There is no information about the patient's medication regimen.", + [], + "not enough information" + ], + "2": [ + "The patient is capable of giving informed consent.", + [ + 5 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "No mention of active suicide ideation in the patient note.", + [], + "not excluded" + ], + "1": [ + "No mention of the patient's weight in the note.", + [], + "not enough information" + ], + "2": [ + "No mention of Deep Brain Stimulation surgery in the patient note.", + [], + "not excluded" + ], + "3": [ + "The patient has severe cognitive deficits and memory dysfunction, indicating a diagnosis of dementia.", + [ + 1 + ], + "excluded" + ], + "4": [ + "No mention of medications in the patient note.", + [], + "not enough information" + ] + } + }, + "NCT01628315": { + "inclusion": { + "0": [ + "The patient note does not mention enrollment in the ASA study or the 3-year extension study.", + [], + "not included" + ], + "1": [ + "The patient note does not mention an MRI performed with a 1.5 T magnet.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "There is no information about MRI image processing issues.", + [], + "not enough information" + ], + "1": [ + "There is no information about MRI time points collection.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-20149": { + "0": { + "NCT01950026": { + "inclusion": { + "0": [ + "The patient note does not mention the patient's ethnic group.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient note does not mention any change in skin sensitivity, illness of an infectious nature, or previously diagnosed diseases that respond negatively to the use of cold.", + [], + "not excluded" + ] + } + }, + "NCT02615912": { + "inclusion": { + "0": [ + "The patient note does not provide information about the patient's Fitzpatrick Skin Type.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient has multiple lesions on her neck, which may be considered a visible skin condition.", + [ + 0, + 1, + 2, + 3, + 4 + ], + "excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201410": { + "0": { + "NCT02264964": { + "inclusion": { + "0": [ + "The patient note does not mention chronic renal failure or the need for hemodialysis.", + [], + "not enough information" + ], + "1": [ + "The patient note does not provide information about the patient's history of central vena catheterization.", + [], + "not enough information" + ], + "2": [ + "The patient note does not mention maintenance hemodialysis after central vena catheterization.", + [], + "not enough information" + ], + "3": [ + "The patient will provide informed consent and comply with the trial protocol.", + [ + 3 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient underwent cardiac catheterization via the right femoral artery, not central venous catheterization.", + [ + 0 + ], + "not excluded" + ], + "1": [ + "There is no information about the patient's ability to use heparin.", + [], + "not enough information" + ], + "2": [ + "The patient will provide informed consent.", + [ + 3 + ], + "not excluded" + ], + "3": [ + "There is no information about the patient having advanced cancer.", + [], + "not enough information" + ], + "4": [ + "There is no information about the patient having or planning arteriovenous fistula surgery in the right arm.", + [], + "not enough information" + ], + "5": [ + "There is no information about any other inappropriate situation.", + [], + "not enough information" + ] + } + }, + "NCT02097186": { + "inclusion": { + "0": [ + "The patient is 67 years old, which is greater than 18 years.", + [ + 0 + ], + "included" + ], + "1": [ + "The patient is willing to provide informed consent.", + [ + 3 + ], + "included" + ], + "2": [ + "There is no information about the patient undergoing elective carotid endarterectomy.", + [], + "not enough information" + ], + "3": [ + "There is no information about the patient undergoing open abdominal aortic aneurysm repair.", + [], + "not enough information" + ], + "4": [ + "There is no information about the patient undergoing endovascular abdominal aneurysm repair.", + [], + "not enough information" + ], + "5": [ + "There is no information about the patient undergoing surgical lower limb revascularisation.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient is a 67-year-old woman, and there is no mention of pregnancy.", + [], + "not excluded" + ], + "1": [ + "There is no mention of significant upper limb peripheral arterial disease.", + [], + "not enough information" + ], + "2": [ + "There is no mention of a previous history of upper limb deep vein thrombosis.", + [], + "not enough information" + ], + "3": [ + "There is no mention of the patient being on glibenclamide or nicorandil.", + [], + "not enough information" + ], + "4": [ + "There is no mention of a known history of myocarditis, pericarditis, or amyloidosis.", + [], + "not enough information" + ], + "5": [ + "There is no mention of the patient's estimated pre-operative glomerular filtration rate.", + [], + "not enough information" + ], + "6": [ + "There is no mention of severe hepatic disease or INR levels.", + [], + "not enough information" + ], + "7": [ + "There is no mention of severe respiratory disease or home oxygen therapy.", + [], + "not enough information" + ], + "8": [ + "There is no mention of the patient being previously enrolled in the trial.", + [], + "not enough information" + ], + "9": [ + "There is no mention of previous axillary surgery.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201411": { + "0": { + "NCT01723137": { + "inclusion": { + "0": [ + "The patient presents with excruciating pain, which is likely greater than or equal to 3 out of 10.", + [ + 0 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient is 40 years old.", + [ + 0 + ], + "not excluded" + ], + "1": [ + "The patient is alert and able to provide informed consent.", + [ + 5 + ], + "not excluded" + ], + "2": [ + "The patient is able to provide informed consent and comply with the trial protocol.", + [ + 5 + ], + "not excluded" + ], + "3": [ + "There is no information indicating the patient is a prisoner.", + [], + "not enough information" + ] + } + }, + "NCT01526382": { + "inclusion": { + "0": [ + "The patient has hypotension and tachycardia, which may suggest shock, but no direct diagnosis of shock or ARDS is mentioned.", + [ + 2, + 3 + ], + "not enough information" + ], + "1": [ + "The patient has hypotension and tachycardia, which may suggest shock, but no direct diagnosis of shock is mentioned.", + [ + 2, + 3 + ], + "not enough information" + ], + "2": [ + "The patient is tachycardic with a heart rate likely over 90/min.", + [ + 2 + ], + "included" + ], + "3": [ + "The patient is tachypneic with a respiratory rate likely over 20/min.", + [ + 2 + ], + "included" + ], + "4": [ + "There is no information about the use of vasopressors or fluid resuscitation.", + [], + "not enough information" + ], + "5": [ + "There is no information about hypoperfusion signs such as urine output, neurologic dysfunction, or plasma lactate levels.", + [], + "not enough information" + ], + "6": [ + "There is no information about ARDS or related criteria.", + [], + "not enough information" + ], + "7": [ + "There is no information about PaO2/FIO2 levels.", + [], + "not enough information" + ], + "8": [ + "There is no information about pulmonary infiltrates or chest radiograph findings.", + [], + "not enough information" + ], + "9": [ + "There is no information about left atrial hypertension or positive pressure ventilation.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient is not moribund as she is conscious and able to provide informed consent.", + [ + 0, + 5 + ], + "not excluded" + ], + "1": [ + "There is no information about a signed do-not-resuscitate order.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201412": { + "0": { + "NCT01551498": { + "inclusion": { + "0": [ + "The patient is 25 years old, which is within the 18-70 age range.", + [ + 0 + ], + "included" + ], + "1": [ + "There is no information about antibodies against thyroid peroxidase.", + [], + "not enough information" + ], + "2": [ + "The patient has a prominent, soft, uniform anterior cervical mass, but no sonographic evidence is mentioned.", + [ + 4 + ], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "There is no evidence in the patient note indicating end-stage thyroiditis.", + [], + "not excluded" + ], + "1": [ + "There is no information about the patient being a smoker or using smokeless tobacco.", + [], + "not enough information" + ], + "2": [ + "There is no information about the patient taking systemic glucocorticoids, interferon-alpha, anti-CD20 antibody, or anti-CTLA-4 antibody.", + [], + "not enough information" + ], + "3": [ + "There is no information about the patient taking medication for autoimmune thyroiditis other than L-thyroxine.", + [], + "not enough information" + ] + } + }, + "NCT00271427": { + "inclusion": { + "0": [ + "The patient has symptoms consistent with thyroid issues, but there is no direct evidence of a clinical diagnosis of AIT or use of LT4.", + [ + 0, + 2, + 4 + ], + "not included" + ] + }, + "exclusion": { + "0": [ + "The patient note does not mention any drug use other than LT4 or any known pathology affecting GIS absorption.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201413": { + "0": { + "NCT02264769": { + "inclusion": { + "0": [ + "The patient recently gave birth naturally, not via elective cesarean delivery.", + [ + 2 + ], + "not included" + ], + "1": [ + "The patient will provide informed consent.", + [ + 6 + ], + "included" + ], + "2": [ + "The patient recently gave birth, indicating a term pregnancy.", + [ + 2 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient will provide informed consent.", + [ + 6 + ], + "not excluded" + ], + "1": [ + "No information about allergy or hypersensitivity to carbetocin or oxytocin.", + [], + "not enough information" + ], + "2": [ + "No conditions that predispose to uterine atony and postpartum hemorrhage are mentioned.", + [], + "not excluded" + ], + "3": [ + "No mention of hepatic, renal, or vascular disease.", + [], + "not excluded" + ] + } + }, + "NCT00163709": { + "inclusion": { + "0": [ + "The patient is 30 years old, which does not meet the age requirement of over 40 years old.", + [ + 0 + ], + "not included" + ] + }, + "exclusion": { + "0": [ + "The patient note does not mention a traumatic cause of dyspnea, severe renal disease, cardiogenic shock, or early transfer to another hospital.", + [], + "not excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201414": { + "0": { + "NCT01624545": { + "inclusion": { + "0": [ + "The patient does not have a newly diagnosed chronic subdural hematoma operated within the last 48 hours.", + [], + "not included" + ], + "1": [ + "The patient is 85 years old, which is older than 18 years.", + [ + 0 + ], + "included" + ], + "2": [ + "The patient will provide informed consent and comply with the trial protocol.", + [ + 4 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient is not in a moribund state prohibiting surgery.", + [], + "not excluded" + ], + "1": [ + "The patient has no foreseeable difficulties in follow-up due to geographic reasons.", + [], + "not excluded" + ], + "2": [ + "There is no information about a recurrent hematoma with the first surgery before study start.", + [], + "not enough information" + ], + "3": [ + "There is no indication of CSH due to spontaneous spinal CSF fistula or meningeosis carcinomatosa.", + [], + "not excluded" + ], + "4": [ + "The patient is male and cannot be pregnant.", + [], + "not applicable" + ], + "5": [ + "There is no mention of metastatic disease or a high possibility to pass away in the next 6 months.", + [], + "not excluded" + ] + } + }, + "NCT01869855": { + "inclusion": { + "0": [ + "The patient is 85 years old, but there is no mention of chronic subdural hematoma.", + [ + 0 + ], + "not included" + ], + "1": [ + "There is no mention of chronic subdural hematoma verified on cranial CT or MRI.", + [], + "not included" + ] + }, + "exclusion": { + "0": [ + "There is no information about the surgeon's decision to perform a craniotomy.", + [], + "not enough information" + ], + "1": [ + "There is no mention of chronic subdural hematoma caused by another underlying illness.", + [], + "not enough information" + ], + "2": [ + "The patient will provide informed consent.", + [ + 4 + ], + "not excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201415": { + "0": { + "NCT00180739": { + "inclusion": { + "0": [ + "The patient is 36 years old and has a differential diagnosis that includes fibroids.", + [ + 0, + 5 + ], + "included" + ], + "1": [ + "There is no information about the couple's fertility history or ovarian function tests.", + [], + "not enough information" + ], + "2": [ + "There is no information about fertility treatment or sperm donation plans.", + [], + "not enough information" + ], + "3": [ + "There is no information about the use or non-use of non-steroidal treatments for excessive vaginal bleeding.", + [], + "not enough information" + ], + "4": [ + "The patient is willing to provide informed consent and comply with the trial protocol.", + [ + 6 + ], + "included" + ], + "5": [ + "There is no information about the patient's ability to communicate sensations during the procedure.", + [], + "not enough information" + ], + "6": [ + "The patient has a differential diagnosis that includes fibroids, but no information on device accessibility.", + [ + 5 + ], + "not enough information" + ], + "7": [ + "There is no information about MRI visibility of tumors.", + [], + "not enough information" + ], + "8": [ + "The ultrasound reports an enlarged uterus, but no specific fibroid size is mentioned.", + [ + 4 + ], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient is not pregnant as confirmed by a negative pregnancy test.", + [ + 3 + ], + "not excluded" + ], + "1": [ + "The uterine size is 18 weeks, which is less than 20 weeks.", + [ + 1 + ], + "not excluded" + ], + "2": [ + "There is no mention of high-risk pregnancy due to uterine factors other than fibroids.", + [], + "not enough information" + ], + "3": [ + "There is no information about the fibroid being more than 50% sub-mucosal or hysteroscopically resectable.", + [], + "not enough information" + ], + "4": [ + "There is no mention of adenomyosis in the patient note.", + [], + "not enough information" + ], + "5": [ + "The patient is not on dialysis.", + [], + "not excluded" + ], + "6": [ + "Hematocrit level is not mentioned, but the complete blood count is normal.", + [ + 2 + ], + "not excluded" + ], + "7": [ + "There is no mention of hemolytic anemia, and the complete blood count is normal.", + [ + 2 + ], + "not excluded" + ], + "8": [ + "There is no mention of unstable cardiac status.", + [], + "not enough information" + ], + "9": [ + "There is no mention of an ASA score.", + [], + "not enough information" + ], + "10": [ + "There is no mention of severe cerebrovascular disease.", + [], + "not enough information" + ], + "11": [ + "There is no mention of anti-coagulation therapy or bleeding disorder.", + [], + "not enough information" + ], + "12": [ + "There is no evidence of uterine pathology other than leiomyoma.", + [], + "not enough information" + ], + "13": [ + "There is no mention of an active pelvic infection or history of pelvic inflammatory disease.", + [], + "not enough information" + ], + "14": [ + "There is no mention of an undiagnosed pelvic mass outside the uterus.", + [], + "not enough information" + ], + "15": [ + "There is no mention of the patient's weight.", + [], + "not enough information" + ], + "16": [ + "There is no mention of extensive abdominal scarring.", + [], + "not enough information" + ], + "17": [ + "There is no mention of contraindications for MR imaging.", + [], + "not enough information" + ], + "18": [ + "There is no mention of intolerance to MRI contrast agents.", + [], + "not enough information" + ], + "19": [ + "The patient is willing to comply with the trial protocol, suggesting she can tolerate the required position.", + [ + 6 + ], + "not excluded" + ], + "20": [ + "There is no mention of an intrauterine contraceptive device.", + [], + "not enough information" + ], + "21": [ + "There is no mention of the patient breastfeeding.", + [], + "not enough information" + ], + "22": [ + "There is no mention of the number or size of fibroids.", + [], + "not enough information" + ] + } + }, + "NCT00277680": { + "inclusion": { + "0": [ + "The patient has symptoms that could be associated with uterine fibroids, but there is no mention of menorrhagia or bulk symptoms.", + [ + 0, + 4, + 5 + ], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "There is no evidence of malignancy in the patient note.", + [], + "not excluded" + ], + "1": [ + "The patient has a negative pregnancy test, indicating she is not currently pregnant.", + [ + 3 + ], + "not excluded" + ], + "2": [ + "There is no mention of small submucous fibroids suitable for hysteroscopic resection.", + [], + "not enough information" + ], + "3": [ + "The patient is 36 years old and not postmenopausal.", + [ + 0 + ], + "not excluded" + ], + "4": [ + "There is no mention of suspected or known adenomyosis.", + [], + "not enough information" + ], + "5": [ + "The physical exam reveals an 18-week sized uterus, which may exceed the umbilical level.", + [ + 1 + ], + "excluded" + ], + "6": [ + "There is no mention of contraindications against laparoscopic surgery.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201416": { + "0": { + "NCT02238756": { + "inclusion": { + "0": [ + "The patient will comply with the trial protocol without any practical issues.", + [ + 4 + ], + "included" + ], + "1": [ + "The patient had an unremarkable physical exam except for slight tremors and almost imperceptible spasticity.", + [ + 1 + ], + "not included" + ], + "2": [ + "There is no information about the patient's BMI in the note.", + [], + "not enough information" + ], + "3": [ + "The criterion is not applicable as the patient is female.", + [], + "not applicable" + ] + }, + "exclusion": { + "0": [ + "The patient was prescribed NSAIDS and a topical muscle relaxant, which are not investigational or non-registered products.", + [ + 2 + ], + "not excluded" + ], + "1": [ + "There is no information about the patient receiving any vaccines within the last 4 weeks.", + [], + "not enough information" + ], + "2": [ + "The patient was prescribed NSAIDS and a topical muscle relaxant, which are not immunosuppressants or immune-modifying drugs.", + [ + 2 + ], + "not excluded" + ], + "3": [ + "There is no mention of an immune deficient condition in the patient note.", + [], + "not enough information" + ], + "4": [ + "There is no mention of a history of autoimmune disease in the patient note.", + [], + "not enough information" + ], + "5": [ + "There is no mention of administration of immunoglobulins or blood products in the patient note.", + [], + "not enough information" + ], + "6": [ + "The patient has acute symptoms such as spastic arm movements, sweating, agitation, anxiety, malaise, difficulty swallowing, and hydrophobia.", + [ + 3 + ], + "excluded" + ], + "7": [ + "The patient has acute symptoms but no mention of significant chronic disease.", + [], + "not enough information" + ], + "8": [ + "There is no mention of major congenital defects in the patient note.", + [], + "not enough information" + ], + "9": [ + "There is no mention of an allergy to rabies vaccine components.", + [], + "not enough information" + ], + "10": [ + "There is no mention of a type I allergy to beta-lactam antibiotics.", + [], + "not enough information" + ], + "11": [ + "There is no mention of current alcohol or drug abuse.", + [], + "not enough information" + ], + "12": [ + "There is no mention of a history of neurological disorders or seizures.", + [], + "not enough information" + ], + "13": [ + "There is no mention of seropositivity for HIV, HBV, or HCV.", + [], + "not enough information" + ], + "14": [ + "The patient is expected to comply with the trial protocol.", + [ + 4 + ], + "not excluded" + ], + "15": [ + "There is no mention of a history of life-threatening anaphylactic reactions.", + [], + "not enough information" + ], + "16": [ + "There is no mention of impaired coagulation.", + [], + "not enough information" + ] + } + }, + "NCT02374814": { + "inclusion": { + "0": [ + "The patient is a 28-year-old female, which fits the age and gender criteria, and she can provide informed consent and comply with the trial protocol.", + [ + 0, + 4 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient is a 28-year-old female, but there is no information about pregnancy, lactation, or contraception.", + [ + 0 + ], + "not enough information" + ], + "1": [ + "There is no information about participation in another clinical trial.", + [], + "not enough information" + ], + "2": [ + "There is no information about previous rabies vaccination.", + [], + "not enough information" + ], + "3": [ + "There is no information about previous rabies immune globulin.", + [], + "not enough information" + ], + "4": [ + "The patient exhibits anxiety and agitation, but it is not clear if this is a major psychiatric disorder.", + [ + 3 + ], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201417": { + "0": { + "NCT01745731": { + "inclusion": { + "0": [ + "The patient is 48 years old, which meets the age criterion.", + [ + 0 + ], + "included" + ], + "1": [ + "No information on standard analytical parameters is provided.", + [], + "not enough information" + ], + "2": [ + "No information on leukocyte count is provided.", + [], + "not enough information" + ], + "3": [ + "No information on neutrophil count is provided.", + [], + "not enough information" + ], + "4": [ + "No information on platelet count is provided.", + [], + "not enough information" + ], + "5": [ + "No information on AST/ALT levels is provided.", + [], + "not enough information" + ], + "6": [ + "No information on creatinine levels is provided.", + [], + "not enough information" + ], + "7": [ + "The patient has a ruptured liver abscess, which is a liver space-occupying lesion.", + [ + 3 + ], + "included" + ], + "8": [ + "No specific type of liver damage is mentioned that matches the five types listed.", + [], + "not enough information" + ], + "9": [ + "No information on metastatic disease or right hepatectomy is provided.", + [], + "not enough information" + ], + "10": [ + "No information on metastatic disease or neoadjuvant chemotherapy is provided.", + [], + "not enough information" + ], + "11": [ + "No information on bilobar liver metastases is provided.", + [], + "not enough information" + ], + "12": [ + "No information on hepatocarcinoma is provided.", + [], + "not enough information" + ], + "13": [ + "The patient has a ruptured liver abscess, which is a liver injury that threatens the viability of the remaining liver tissue.", + [ + 3 + ], + "included" + ], + "14": [ + "The patient will provide informed consent and comply with the trial protocol.", + [ + 5 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient has common variable immunodeficiency, which is not a tumor or hematologic disease.", + [ + 0 + ], + "not excluded" + ], + "1": [ + "The patient has a blood pressure of 80/40, indicating hypotension, not hypertension.", + [ + 0 + ], + "not excluded" + ], + "2": [ + "There is no mention of severe heart failure in the patient note.", + [], + "not enough information" + ], + "3": [ + "There is no mention of malignant ventricular arrhythmias or unstable angina.", + [], + "not enough information" + ], + "4": [ + "There is no mention of deep vein thrombosis in the last 3 months.", + [], + "not enough information" + ], + "5": [ + "There is no mention of adjunctive therapy including hyperbaric oxygen, vasoactive substances, agents or angiogenesis inhibitors against Cox-II.", + [], + "not enough information" + ], + "6": [ + "There is no mention of the patient's BMI.", + [], + "not enough information" + ], + "7": [ + "There is no mention of alcoholism.", + [], + "not enough information" + ], + "8": [ + "There is no mention of proliferative retinopathy.", + [], + "not enough information" + ], + "9": [ + "There is no mention of a concomitant disease that reduces life expectancy to less than a year.", + [], + "not enough information" + ], + "10": [ + "The patient will comply with the trial protocol without any practical issues.", + [ + 5 + ], + "not excluded" + ], + "11": [ + "There is no mention of heart failure or ejection fraction (EF) <30%.", + [], + "not enough information" + ], + "12": [ + "There is no mention of stroke or myocardial infarction within the last 3 months.", + [], + "not enough information" + ], + "13": [ + "The patient is a male, so this criterion is not applicable.", + [], + "not applicable" + ] + } + }, + "NCT02556359": { + "inclusion": { + "0": [ + "The patient is 48 years old, not a child.", + [ + 0 + ], + "not included" + ], + "1": [ + "The patient has a history of Common Variable Immunodeficiency (CVID).", + [ + 0 + ], + "included" + ], + "2": [ + "There is no information about the patient being a genetic patient.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient will provide informed consent.", + [ + 5 + ], + "not excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201418": { + "0": { + "NCT00557219": { + "inclusion": { + "0": [ + "The patient underwent major surgery, but it is not specified as cardiac surgery.", + [], + "not enough information" + ], + "1": [ + "The patient has generalized edema and elevated serum creatinine, which are risk factors for acute renal failure.", + [ + 1, + 3 + ], + "included" + ], + "2": [ + "The patient has oliguria with urine output < 0.2 mL/kg/hr.", + [ + 0 + ], + "included" + ], + "3": [ + "There is no information about furosemide administration.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient will provide informed consent.", + [ + 7 + ], + "not excluded" + ], + "1": [ + "The patient does not have chronic renal failure with chronic renal replacement therapy.", + [], + "not excluded" + ], + "2": [ + "The patient's serum creatinine is 1.3 mg/dL, which is not greater than 2 mg/dL.", + [ + 3 + ], + "not excluded" + ] + } + }, + "NCT01260883": { + "inclusion": { + "0": [ + "The patient is a 6-month-old infant admitted to the hospital following surgery.", + [ + 0 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "No mention of bleeding history in the patient or family.", + [], + "not excluded" + ], + "1": [ + "No mention of coagulopathy.", + [], + "not excluded" + ], + "2": [ + "No mention of gastrointestinal bleeding history.", + [], + "not excluded" + ], + "3": [ + "The patient has elevated blood urea nitrogen and serum creatinine, indicating possible renal issues.", + [ + 3 + ], + "excluded" + ], + "4": [ + "No mention of premature birth or gestational age.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201419": { + "0": { + "NCT00256529": { + "inclusion": { + "0": [ + "The patient is 52 years old and presents with dysphagia.", + [ + 0, + 2 + ], + "included" + ], + "1": [ + "The patient is likely able to undergo EGD and biopsies as there are no contraindications mentioned.", + [], + "not enough information" + ], + "2": [ + "There is no mention of significant cardiopulmonary disease or contraindications to EGD.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "No evidence of contradiction to EGD and/or biopsies such as Boerhaave's syndrome, bleeding disorder, or elevated INR.", + [], + "not excluded" + ], + "1": [ + "The patient will provide informed consent and comply with the trial protocol.", + [ + 5 + ], + "not excluded" + ], + "2": [ + "No mention of esophageal varices in the patient note.", + [], + "not enough information" + ] + } + }, + "NCT02509286": { + "inclusion": { + "0": [ + "The patient has progressive dysphagia, but there is no direct evidence of histologically verified adenocarcinoma.", + [], + "not enough information" + ], + "1": [ + "There is no information about the pre-treatment stage of the cancer.", + [], + "not enough information" + ], + "2": [ + "The patient is 52 years old, which is \u226518 years.", + [ + 0 + ], + "included" + ], + "3": [ + "There is no information about prior abdominal or thoracic radiotherapy.", + [], + "not enough information" + ], + "4": [ + "There is no information about the patient's ECOG Performance status.", + [], + "not enough information" + ], + "5": [ + "There is no information about the patient's cardiac function.", + [], + "not enough information" + ], + "6": [ + "There is no information about the patient's bone marrow function.", + [], + "not enough information" + ], + "7": [ + "There is no information about the patient's respiratory function.", + [], + "not enough information" + ], + "8": [ + "There is no information about the patient's renal function.", + [], + "not enough information" + ], + "9": [ + "There is no information about the patient's liver function.", + [], + "not enough information" + ], + "10": [ + "The patient will provide informed consent.", + [ + 5 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient has a history of dysphagia, but there is no mention of tumor histology.", + [], + "not enough information" + ], + "1": [ + "There is no information about the operability or metastatic status of the esophageal adenocarcinoma.", + [], + "not enough information" + ], + "2": [ + "There is no information about the staging of the cancer.", + [], + "not enough information" + ], + "3": [ + "The patient has dysphagia, but there is no mention of gastric carcinoma.", + [], + "not enough information" + ], + "4": [ + "There is no mention of prior chemotherapy for cancer.", + [], + "not enough information" + ], + "5": [ + "There is no mention of cardiac disease.", + [], + "not enough information" + ], + "6": [ + "There is no mention of lung disease or FEV1 values.", + [], + "not enough information" + ], + "7": [ + "There is no mention of peripheral neuropathy.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201420": { + "0": { + "NCT01594385": { + "inclusion": { + "0": [ + "The patient is a trauma patient with abdominal issues, likely undergoing damage control/open abdomen management.", + [ + 0, + 1, + 4 + ], + "included" + ], + "1": [ + "The patient is 32 years old.", + [ + 0 + ], + "included" + ], + "2": [ + "There is no information about the patient's life expectancy.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient is not a prisoner.", + [], + "not applicable" + ], + "1": [ + "The patient is a 32-year-old woman, and there is no mention of pregnancy.", + [ + 0 + ], + "not excluded" + ], + "2": [ + "The patient is 32 years old.", + [ + 0 + ], + "not excluded" + ] + } + }, + "NCT02255487": { + "inclusion": { + "0": [ + "The patient is a 32-year-old woman, which meets the age and gender requirement.", + [ + 0 + ], + "included" + ], + "1": [ + "The patient will provide informed consent.", + [ + 6 + ], + "included" + ], + "2": [ + "The patient has abdominal trauma with tenderness, guarding, and rebound, but it is not specified if an open abdominal laparotomy is required.", + [ + 4 + ], + "not enough information" + ], + "3": [ + "The patient has a tender abdomen with guarding and rebound, but it is not specified if an open abdominal laparotomy is required.", + [ + 4 + ], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "No mention of allergy to Chlorhexidine Gluconate (CHG) in the patient note.", + [], + "not excluded" + ], + "1": [ + "No information about the Estimated Abbreviated Injury Scale (AIS) score.", + [], + "not enough information" + ], + "2": [ + "No information about the ASA score or the patient's stability for surgery.", + [], + "not enough information" + ], + "3": [ + "The patient is a 32-year-old woman, but there is no mention of pregnancy or breastfeeding.", + [ + 0 + ], + "not excluded" + ], + "4": [ + "No mention of damage control laparotomy in the patient note.", + [], + "not excluded" + ], + "5": [ + "No mention of an abdominal incision created prior to the operating room.", + [], + "not excluded" + ], + "6": [ + "No mention of the patient being enrolled in another clinical trial.", + [], + "not excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201421": { + "0": { + "NCT01520155": { + "inclusion": { + "0": [ + "The patient has systemic Lupus erythematosus as indicated by symptoms and lab results.", + [ + 0, + 1, + 2 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient has systemic Lupus erythematosus as indicated by symptoms and lab results.", + [ + 0, + 1, + 2 + ], + "not excluded" + ] + } + }, + "NCT00997100": { + "inclusion": { + "0": [ + "The patient is 21 years old, which is greater than 18.", + [ + 0 + ], + "included" + ], + "1": [ + "The patient fulfills at least 4 criteria for SLE: arthritis, rash, positive ANA, and renal disorder.", + [ + 0, + 1, + 2, + 3 + ], + "included" + ], + "2": [ + "The patient presents with active SLE disease with arthritis and inflammatory-type skin rash.", + [ + 1 + ], + "included" + ], + "3": [ + "The patient has arthritis with swelling and tenderness in more than 2 joints.", + [ + 1 + ], + "included" + ], + "4": [ + "The patient has an inflammatory-type skin rash.", + [ + 1 + ], + "included" + ], + "5": [ + "There is no information about oral ulcers.", + [], + "not enough information" + ], + "6": [ + "The patient's hemoglobin level is not provided.", + [], + "not enough information" + ], + "7": [ + "The patient's absolute neutrophil count is not provided.", + [], + "not enough information" + ], + "8": [ + "The patient's total bilirubin level is not provided.", + [], + "not enough information" + ], + "9": [ + "The patient's AST/ALT levels are not provided.", + [], + "not enough information" + ], + "10": [ + "The patient can take and retain oral medication.", + [], + "not enough information" + ], + "11": [ + "The patient is willing and able to sign informed consent.", + [ + 4 + ], + "included" + ], + "12": [ + "The patient is willing and able to comply with the protocol.", + [ + 4 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient has active renal lupus as indicated by protein and RBC casts in urine.", + [ + 3 + ], + "excluded" + ], + "1": [ + "There is no information about the patient's renal function or GFR.", + [], + "not enough information" + ], + "2": [ + "There is no information about the patient's corticosteroid use.", + [], + "not enough information" + ], + "3": [ + "There is no information about the patient receiving intravenous corticosteroids.", + [], + "not enough information" + ], + "4": [ + "There is no information about the patient receiving intravenous cyclophosphamide.", + [], + "not enough information" + ], + "5": [ + "There is no information about the patient receiving anti-rheumatic/immunosuppressive drugs.", + [], + "not enough information" + ], + "6": [ + "There is no information about the patient receiving B-cell depletion therapy.", + [], + "not enough information" + ], + "7": [ + "There is no information about the patient using potent inhibitors or inducers of CYP3A4.", + [], + "not enough information" + ], + "8": [ + "There is no information about the patient's cardiac history.", + [], + "not enough information" + ], + "9": [ + "There is no information about the patient's QT/QTc interval.", + [], + "not enough information" + ], + "10": [ + "There is no information about the patient's risk factors for torsade de pointes.", + [], + "not enough information" + ], + "11": [ + "There is no information about the patient using medications that prolong the QT interval.", + [], + "not enough information" + ], + "12": [ + "There is no information about the patient's history of ischemic CNS disease.", + [], + "not enough information" + ], + "13": [ + "There is no information about the patient having a current malignancy.", + [], + "not enough information" + ], + "14": [ + "There is no information about the patient having a current severe infection.", + [], + "not enough information" + ], + "15": [ + "There is no information about the patient's screening for hepatitis B, C, or HIV.", + [], + "not enough information" + ], + "16": [ + "There is no information about the patient having a history of drug abuse.", + [], + "not enough information" + ], + "17": [ + "There is no information about the patient having major surgery recently.", + [], + "not enough information" + ], + "18": [ + "There is no information about the patient's hypersensitivity to ABR-215757.", + [], + "not enough information" + ], + "19": [ + "The patient is a female of child-bearing potential, but there is no information about her contraception use.", + [], + "not enough information" + ], + "20": [ + "There is no information about the patient being pregnant or lactating.", + [], + "not enough information" + ], + "21": [ + "There is no information about the patient's participation in other studies.", + [], + "not enough information" + ], + "22": [ + "There is no information about other significant, unstable medical diseases.", + [], + "not enough information" + ], + "23": [ + "There is no information about the patient likely receiving steroids or immunosuppressants for non-SLE conditions.", + [], + "not enough information" + ], + "24": [ + "There is no information about the patient receiving a vaccination recently.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201422": { + "0": { + "NCT00723788": { + "inclusion": { + "0": [ + "The patient is 15 years old, presents to the ER with suspected appendicitis, and has received an ultrasound of the abdomen.", + [ + 0, + 5 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient note does not mention any issues with MRI metal screening, claustrophobia, or need for sedation.", + [], + "not excluded" + ] + } + }, + "NCT00236912": { + "inclusion": { + "0": [ + "The patient has symptoms of acute appendicitis and radiologic evidence of appendicitis, but no evidence of complicated appendicitis.", + [ + 0, + 1, + 5 + ], + "not included" + ], + "1": [ + "There is no information about the patient's ability to take medicine orally after surgery.", + [], + "not enough information" + ], + "2": [ + "The patient is female but there is no information about birth control use.", + [ + 3 + ], + "not included" + ] + }, + "exclusion": { + "0": [ + "No mention of allergy to study medications.", + [], + "not excluded" + ], + "1": [ + "No indication of life expectancy less than 72 hours.", + [], + "not excluded" + ], + "2": [ + "No information on APACHE II score.", + [], + "not enough information" + ], + "3": [ + "No information on neutropenia or white blood cell count.", + [], + "not enough information" + ], + "4": [ + "No information on HIV status or CD4 count.", + [], + "not enough information" + ], + "5": [ + "No information on platelet count.", + [], + "not enough information" + ], + "6": [ + "No information on malnutrition or albumin levels.", + [], + "not enough information" + ], + "7": [ + "No mention of condition requiring major tranquilizers.", + [], + "not excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201423": { + "0": { + "NCT02219360": { + "inclusion": { + "0": [ + "The patient shows symptoms consistent with acute exacerbation of COPD but is not explicitly stated to be hospitalized.", + [ + 0, + 3, + 5 + ], + "not enough information" + ], + "1": [ + "The patient is 63 years old, which is greater than 40.", + [ + 0 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient's symptoms and history suggest acute exacerbation of COPD as the cause of hospitalization.", + [ + 0, + 3, + 5 + ], + "not excluded" + ], + "1": [ + "Chest x-ray shows hyperinflation but no signs of congestive heart failure.", + [ + 6 + ], + "not excluded" + ], + "2": [ + "No information about chest CT findings is provided.", + [], + "not enough information" + ], + "3": [ + "No evidence of serious cardiac failure, renal insufficiency, or hepatic dysfunction is mentioned.", + [], + "not enough information" + ] + } + }, + "NCT00170222": { + "inclusion": { + "0": [ + "The patient has symptoms consistent with an acute exacerbation of COPD.", + [ + 0, + 3, + 5 + ], + "included" + ], + "1": [ + "There is no information about the patient's ability to perform lung function tests.", + [], + "not enough information" + ], + "2": [ + "The patient can take oral medication.", + [ + 7 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The criterion is not applicable as the patient is male.", + [], + "not applicable" + ], + "1": [ + "There is no mention of antibiotic pretreatment for the current exacerbation.", + [], + "not enough information" + ], + "2": [ + "There is no mention of corticosteroid pretreatment for the current exacerbation.", + [], + "not enough information" + ], + "3": [ + "The chest X-ray shows hyperinflation with no consolidation, indicating no progression or new abnormalities.", + [ + 6 + ], + "not excluded" + ], + "4": [ + "There is no mention of mechanical ventilation being required.", + [], + "not enough information" + ], + "5": [ + "There is no mention of a history of bronchiectasis.", + [], + "not enough information" + ], + "6": [ + "There is no mention of lung malignancy.", + [], + "not enough information" + ], + "7": [ + "There is no mention of other diseases likely to require antibiotic therapy.", + [], + "not enough information" + ], + "8": [ + "There is no mention of significant gastrointestinal or other conditions affecting drug absorption.", + [], + "not enough information" + ], + "9": [ + "There is no mention of congestive heart failure or stroke.", + [], + "not enough information" + ], + "10": [ + "There is no mention of immunodeficiency disorders or use of immunosuppressive drugs.", + [], + "not enough information" + ], + "11": [ + "There is no mention of cystic fibrosis.", + [], + "not enough information" + ], + "12": [ + "There is no mention of tuberculosis.", + [], + "not enough information" + ], + "13": [ + "There is no mention of impaired renal function.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201424": { + "0": { + "NCT02229695": { + "inclusion": { + "0": [ + "The patient is a 33-year-old male who is likely undergoing emergency laparotomy due to spleen rupture and will have temporary abdominal closure.", + [ + 0, + 5 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient's vital signs are critical, but there is no direct mention of the surgeon's estimate of survival.", + [ + 3 + ], + "not enough information" + ] + } + }, + "NCT01771861": { + "inclusion": { + "0": [ + "The patient presented to the ER with trauma-related symptoms, but there is no direct evidence of trauma team activation.", + [], + "not enough information" + ], + "1": [ + "The patient has a spleen rupture and extended intraperitoneal hemorrhage, which likely results in an Injury Severity Score >15.", + [ + 0, + 1, + 5 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient presented to the ER with acute abdominal pain a week after the injury, indicating secondary admittance more than 24 hours post-injury.", + [ + 0, + 1 + ], + "excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201425": { + "0": { + "NCT00282269": { + "inclusion": { + "0": [ + "The patient has a GCS of 6/15, indicating severe traumatic brain injury, but CT scan results are not available.", + [ + 5 + ], + "not enough information" + ], + "1": [ + "The patient is 8 years old, which is within the required age range.", + [ + 0 + ], + "included" + ], + "2": [ + "There is no information about the patient being mechanically ventilated.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient was transferred to the emergency department, but there is no information on the timing of randomization.", + [ + 3 + ], + "not enough information" + ], + "1": [ + "The patient fell and struck his head, but there is no mention of a penetrating brain injury.", + [ + 0 + ], + "not excluded" + ], + "2": [ + "The patient has a GCS of 6/15 and asymmetrical pupils, not fixed dilated pupils and GCS = 3.", + [ + 5 + ], + "not excluded" + ], + "3": [ + "There is no mention of a cervical spinal cord injury.", + [], + "not excluded" + ], + "4": [ + "There is no mention of any neurodevelopmental disability prior to injury.", + [], + "not excluded" + ], + "5": [ + "There is no mention of an acute isolated epidural hematoma.", + [], + "not excluded" + ], + "6": [ + "There is no mention of a post-traumatic seizure or CT scan results.", + [], + "not excluded" + ], + "7": [ + "The patient's blood pressure is high, not low, and there is no mention of refractory shock.", + [ + 4 + ], + "not excluded" + ] + } + }, + "NCT02378311": { + "inclusion": { + "0": [ + "The patient is 8 years old, which falls within the 0-15 years inclusive range.", + [ + 0 + ], + "included" + ], + "1": [ + "The patient was transferred to the emergency department, which implies presentation to a hospital.", + [ + 3 + ], + "included" + ], + "2": [ + "The patient sustained an injury as indicated by symptoms like drowsiness, vomiting, and impaired movement.", + [ + 2, + 5 + ], + "included" + ], + "3": [ + "The injury was due to a fall from a bicycle, which is a non-motorized bicycle.", + [ + 0 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient was not involved in a motor vehicle collision.", + [], + "not excluded" + ], + "1": [ + "The patient was not injured by another rider.", + [], + "not excluded" + ], + "2": [ + "There is no mention of the bicycle being fitted with 'bull bars'.", + [], + "not enough information" + ], + "3": [ + "The patient will provide informed consent and comply with the trial protocol.", + [ + 7 + ], + "not excluded" + ], + "4": [ + "The patient was not dead on arrival.", + [], + "not excluded" + ], + "5": [ + "The patient is alive during admission.", + [], + "not excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201427": { + "0": { + "NCT01187901": { + "inclusion": { + "0": [ + "The patient is 21 years old and has a family history of multiple polyps, which suggests a clinical diagnosis of FAP.", + [ + 0, + 3 + ], + "included" + ], + "1": [ + "There is no mention of duodenal polyps in the patient note.", + [], + "not included" + ], + "2": [ + "There is no information about recent surgeries in the patient note.", + [], + "not enough information" + ], + "3": [ + "There is no information about the patient's WHO performance status.", + [], + "not enough information" + ], + "4": [ + "There is no information about the patient's bone marrow function.", + [], + "not enough information" + ], + "5": [ + "There is no information about the patient's liver function.", + [], + "not enough information" + ], + "6": [ + "There is no information about the patient's use of NSAIDs.", + [], + "not enough information" + ], + "7": [ + "The patient will provide informed consent and comply with the trial protocol.", + [ + 5 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "No mention of prior treatment with investigational 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], + "11": [ + "No clinical laboratory values provided.", + [], + "not enough information" + ], + "12": [ + "No clinical laboratory values provided.", + [], + "not enough information" + ], + "13": [ + "No clinical laboratory values provided.", + [], + "not enough information" + ], + "14": [ + "No clinical laboratory values provided.", + [], + "not enough information" + ], + "15": [ + "No clinical laboratory values provided.", + [], + "not enough information" + ], + "16": [ + "No mention of gastrointestinal bleeding.", + [], + "not enough information" + ], + "17": [ + "No mention of anti-coagulation medication.", + [], + "not enough information" + ], + "18": [ + "Not applicable as the patient is male.", + [], + "not applicable" + ], + "19": [ + "No mention of hypersensitivity to sulindac or erlotinib.", + [], + "not enough information" + ] + } + }, + "NCT01713881": { + "inclusion": { + "0": [ + "The patient had adenomas found on sigmoidoscopy, which is similar to colonoscopy.", + [ + 3, 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], + "4": [ + "There is no mention of any fractures in the patient note.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "No mention of severe neuropathic disease such as neurogenic osteoarthropathies.", + [], + "not excluded" + ], + "1": [ + "No mention of steroid use or conditions like idiopathic osteoporosis, immobilization, hyperparathyroidism, or hyperthyroidism.", + [], + "not excluded" + ], + "2": [ + "No mention of diseases affecting bone metabolism such as alcoholism, chronic drug use, chronic gastrointestinal disease, renal or hepatic impairment.", + [], + "not excluded" + ], + "3": [ + "No mention of chronic treatment with antacids, estrogen, adrenal or anabolic steroids, anticonvulsants, anticoagulants, or pharmacologic doses of Vitamin A supplements.", + [], + "not excluded" + ], + "4": [ + "No mention of the patient being on rosiglitazone or pioglitazone medications.", + [], + "not excluded" + ], + "5": [ + "No mention of high energy trauma.", + [], + "not excluded" + ], + "6": [ + "No mention of pathological fractures of other origin.", + [], + "not excluded" + ], + "7": [ + "No mention of history of fluoride, bisphosphonate, calcitonin or tamoxifen use.", + [], + "not excluded" + ], + "8": [ + "The patient has significant hypertension, but it is not stated as uncontrolled.", + [ + 1 + ], + "not enough information" + ], + "9": [ + "No mention of MRI contraindications.", + [], + "not excluded" + ], + "10": [ + "No mention of body mass index, but no evidence suggests it is greater than 35.", + [], + "not excluded" + ] + } + }, + "NCT01978834": { + "inclusion": { + "0": [ + "The patient is female.", + [ + 0 + ], + "included" + ], + "1": [ + "The patient is 51 years old, which is within the age range of 50 to 89 years.", + [ + 0 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient note does not mention opting out of research contact.", + [], + "not excluded" + ], + "1": [ + "The patient is able to provide informed consent and comply with the trial protocol.", + [ + 5 + ], + "not excluded" + ], + "2": [ + "There is no mention of hip BMD measurement being infeasible.", + [], + "not excluded" + ], + "3": [ + "There is no mention of open leg or arm wounds.", + [], + "not excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201430": { + "0": { + "NCT00721006": { + "inclusion": { + "0": [ + "The patient is a 72-year-old man, which is older than 18 years.", + [ + 0 + ], + "included" + ], + "1": [ + "There is no information about ABI measurements in the patient note.", + [], + "not enough information" + ], + "2": [ + "The patient experiences calf pain when walking uphill, but no mention of resting ischemic pain, claudication at 100 meters, or non-healing ulcers.", + [ + 0 + ], + "not enough information" + ], + "3": [ + "The patient has claudication symptoms.", + [ + 0 + ], + "included" + ], + "4": [ + "There is no information about the patient's candidacy for surgical or percutaneous 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+ [], + "not enough information" + ], + "9": [ + "No serum creatinine level is provided.", + [], + "not enough information" + ], + "10": [ + "The patient is male, so pregnancy criteria do not apply.", + [], + "not applicable" + ], + "11": [ + "The patient had a myocardial infarction 2 years ago, which is not recent.", + [ + 2 + ], + "not excluded" + ] + } + }, + "NCT02273232": { + "inclusion": { + "0": [ + "The patient has symptoms consistent with peripheral arterial disease, such as calf pain when walking and diminished pulses, but there is no direct mention of a diagnosis of moderate PVD.", + [ + 0, + 7 + ], + "not enough information" + ], + "1": [ + "The patient has new claudication symptoms, but there is no information about Rutherford or Fontaine staging.", + [ + 0, + 1 + ], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "No mention of upper limb PVD in the patient note.", + [], + "not excluded" + ], + "1": [ + "The patient had a myocardial infarction 2 years ago and a transient ischemic attack 6 months ago, but no severe cardiac condition is mentioned.", + [ + 2 + ], + "not enough information" + ], + "2": [ + "No information about risk classification for exercise training.", + [], + "not enough information" + ], + "3": [ + "No mention of a severe respiratory condition in the patient note.", + [], + "not excluded" + ], + "4": [ + "No mention of previous upper limb deep vein thrombosis.", + [], + "not excluded" + ], + "5": [ + "The patient is not on glibenclamide or nicorandil.", + [ + 4 + ], + "not excluded" + ], + "6": [ + "No mention of Raynaud's Disease in the patient note.", + [], + "not excluded" + ], + "7": [ + "No mention of contraindications for MRA.", + [], + "not excluded" + ], + "8": [ + "The patient is male, so pregnancy is not applicable.", + [], + "not applicable" + ], + "9": [ + "No mention of previous major limb amputation.", + [], + "not excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-20151": { + "0": { + "NCT01142245": { + "inclusion": { + "0": [ + "The patient is 44 years old, which is greater than 18.", + [ + 0 + ], + "included" + ], + "1": [ + "The patient has symptoms of bleeding, but there is no confirmation of ulcer bleeding with Forrest classification.", + [ + 0 + ], + "not enough information" + ], + "2": [ + "There is no information about endoscopic hemostasis being achieved.", + [], + "not enough information" + ], + "3": [ + "The patient will provide informed consent.", + [ + 4 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient will provide informed consent.", + [ + 4 + ], + "not excluded" + ], + "1": [ + "No information about Forrest classification is provided.", + [], + "not enough information" + ], + "2": [ + "No mention of unsuccessful endoscopic treatment or need for immediate surgery.", + [], + "not enough information" + ], + "3": [ + "The patient is receiving active treatment in the ICU.", + [ + 3 + ], + "not excluded" + ], + "4": [ + "No mention of polytrauma, severe injury, unconsciousness, burns, or need for continuous artificial ventilation.", + [], + "not excluded" + ], + "5": [ + "No mention of upper GI malignancy or disseminated malignant disease.", + [], + "not excluded" + ], + "6": [ + "No mention of esophageal varices.", + [], + "not excluded" + ], + "7": [ + "No mention of a Mallory-Weiss lesion.", + [], + "not excluded" + ], + "8": [ + "No mention of phenytoin or theophylline treatment.", + [], + "not excluded" + ], + "9": [ + "No mention of PPI or H2RAs use within 3 days of admission.", + [], + "not excluded" + ] + } + }, + "NCT00843063": { + "inclusion": { + "0": [ + "The patient has upper gastrointestinal bleeding, but there is no information about low-dose aspirin use.", + [ + 0 + ], + "not enough information" + ], + "1": [ + "There is no information about endoscopy findings in the patient note.", + [], + "not enough information" + ], + "2": [ + "There is no information about the requirement for continuous low-dose aspirin for secondary prevention.", + [], + "not enough information" + ], + "3": [ + "The patient is 44 years old, which is older than 18.", + [ + 0 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "No mention of concurrent erosive or ulcerative esophagitis.", + [], + "not enough information" + ], + "1": [ + "No mention of pyloric stenosis.", + [], + "not enough information" + ], + "2": [ + "No mention of previous gastric or duodenal surgery.", + [], + "not enough information" + ], + "3": [ + "No mention of thrombocytopenia.", + [], + "not enough information" + ], + "4": [ + "No mention of renal failure.", + [], + "not enough information" + ], + "5": [ + "No mention of active cancer.", + [], + "not enough information" + ], + "6": [ + "No mention of allergy to aspirin, famotidine, or pantoprazole.", + [], + "not enough information" + ], + "7": [ + "The patient is male, so pregnancy-related criteria are not applicable.", + [], + "not applicable" + ], + "8": [ + "No mention of psychosomatic disorder.", + [], + "not enough information" + ], + "9": [ + "No mention of planned co-prescription of NSAIDs, corticosteroids, or anticoagulants.", + [], + "not enough information" + ], + "10": [ + "No mention of disorders affecting drug absorption.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-20152": { + "0": { + "NCT02532452": { + "inclusion": { + "0": [ + "The patient is immunocompromised and has evidence of viral infection.", + [ + 1, + 3 + ], + "included" + ], + "1": [ + "The patient is 62 years old.", + [ + 0 + ], + "included" + ], + "2": [ + "No information about stem cell transplant.", + [], + "not applicable" + ], + "3": [ + "The patient is on immunosuppressive medications including prednisone.", + [ + 1 + ], + "not enough information" + ], + "4": [ + "No information about the patient's ability to receive CTL infusion in Cincinnati.", + [], + "not enough information" + ], + "5": [ + "The patient will provide informed consent.", + [ + 4 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "No mention of GVHD in the patient note.", + [], + "not excluded" + ], + "1": [ + "No mention of bacterial or fungal infection in the patient note.", + [], + "not excluded" + ], + "2": [ + "No mention of malignancy relapse in the patient note.", + [], + "not excluded" + ], + "3": [ + "No mention of ATG or alemtuzumab infusion in the patient note.", + [], + "not excluded" + ] + } + }, + "NCT00034437": { + "inclusion": { + "0": [ + "The patient is 62 years old, which is within the age range of 18-65.", + [ + 0 + ], + "included" + ], + "1": [ + "The presence of owl's eye inclusion bodies suggests CMV infection.", + [ + 3 + ], + "included" + ], + "2": [ + "The patient will provide informed consent.", + [ + 4 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient has owl's eye inclusion bodies, indicating CMV infection, not seronegative.", + [ + 3 + ], + "not excluded" + ], + "1": [ + "No information on blood counts is provided.", + [], + "not enough information" + ], + "2": [ + "No known history of heart, lung, kidney, liver, or bleeding disorder is mentioned.", + [], + "not enough information" + ], + "3": [ + "No diagnosis of HIV infection is mentioned.", + [], + "not enough information" + ], + "4": [ + "The patient is on immunosuppressive medications, indicating an immunodeficiency state.", + [ + 1 + ], + "excluded" + ], + "5": [ + "No history of intravenous drug use is mentioned.", + [], + "not enough information" + ], + "6": [ + "The patient is male, so not applicable for pregnancy.", + [], + "not applicable" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-20153": { + "0": { + "NCT01326507": { + "inclusion": { + "0": [ + "The patient presents with symptoms suggestive of pulmonary embolism, but there is no direct diagnosis mentioned.", + [ + 0 + ], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient is not under guardianship.", + [], + "not excluded" + ], + "1": [ + "There is no information about the patient's social insurance status.", + [], + "not enough information" + ], + "2": [ + "The patient is male, so this criterion is not applicable.", + [], + "not applicable" + ], + "3": [ + "The patient will provide informed consent.", + [ + 3 + ], + "not excluded" + ], + "4": [ + "There is no mention of a myocardial infarction in the last 10 days.", + [], + "not excluded" + ] + } + }, + "NCT01139632": { + "inclusion": { + "0": [ + "The patient presented with chest pain, which may indicate intermediate risk for CAD.", + [ + 0 + ], + "included" + ], + "1": [ + "The patient is 65 years old, which is older than 18.", + [ + 0 + ], + "included" + ], + "2": [ + "The patient will provide informed consent.", + [ + 3 + ], + "included" + ], + "3": [ + "The patient has chest pain, which may indicate intermediate risk for CAD.", + [ + 0 + ], + "included" + ], + "4": [ + "The patient has chest pain, but no information on stress tests.", + [ + 0 + ], + "not enough information" + ], + "5": [ + "There is no information about stress tests.", + [], + "not enough information" + ], + "6": [ + "There is no information about stress tests or arrhythmias.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient presents with acute onset of chest pain, but there is no mention of acute coronary syndrome.", + [ + 0 + ], + "not excluded" + ], + "1": [ + "There is no mention of ST segment deviation on ECG.", + [], + "not enough information" + ], + "2": [ + "There is no mention of cardiac troponin elevation.", + [], + "not enough information" + ], + "3": [ + "The patient has chest pain, but no mention of positive tests for myocardial ischemia.", + [ + 0 + ], + "not enough information" + ], + "4": [ + "There is no mention of hemodynamic instability.", + [], + "not enough information" + ], + "5": [ + "The patient will provide informed consent.", + [ + 3 + ], + "not excluded" + ], + "6": [ + "The patient is 65 years old.", + [ + 0 + ], + "not excluded" + ], + "7": [ + "There is no mention of participation in an investigational study within the previous 30 days.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-20154": { + "0": { + "NCT00844987": { + "inclusion": { + "0": [ + "The patient experienced typical chest pain with substernal location and radiation to the left shoulder and jaw.", + [ + 0 + ], + "included" + ], + "1": [ + "The patient has ST-segment elevations in the ECG.", + [ + 5 + ], + "included" + ], + "2": [ + "The patient underwent coronary angiography.", + [ + 7 + ], + "included" + ], + "3": [ + "The patient will provide informed consent and comply with the trial protocol.", + [ + 11 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient has no known past history of a myocardial infarction.", + [], + "not excluded" + ], + "1": [ + "The patient will provide informed consent and comply with the trial protocol.", + [ + 11 + ], + "not excluded" + ] + } + }, + "NCT01243255": { + "inclusion": { + "0": [ + "The patient has hypercholesterolemia, but there is no mention of lipid lowering drug treatment.", + [ + 1 + ], + "not enough information" + ], + "1": [ + "There is no information about the duration of lipid lowering drug treatment.", + [], + "not enough information" + ], + "2": [ + "There is no information about changes in lipid lowering drug/dose.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient will provide informed consent.", + [ + 11 + ], + "not excluded" + ], + "1": [ + "There is no information about a blood sample taken for lipid profile and glucose.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-20155": { + "0": { + "NCT02407106": { + "inclusion": { + "0": [ + "The patient does not have a history of rheumatic heart disease.", + [], + "not included" + ] + }, + "exclusion": { + "0": [ + "The patient is not diagnosed with rheumatic fever, so the criterion is not applicable.", + [], + "not applicable" + ], + "1": [ + "The patient will comply with the trial protocol and take the tablets.", + [ + 4 + ], + "not excluded" + ] + } + }, + "NCT02118818": { + "inclusion": { + "0": [ + "The patient note does not mention any clinical or echocardiographic signs of RHD.", + [], + "not included" + ] + }, + "exclusion": { + "0": [ + "The patient note does not mention congenital heart disease.", + [], + "not excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-20156": { + "0": { + "NCT02375451": { + "inclusion": { + "0": [ + "The patient note does not mention any history of radioiodine therapy.", + [], + "not included" + ], + "1": [ + "The patient note does not mention any history of radioiodine therapy.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient is likely English-speaking as she will provide informed consent and comply with the trial protocol.", + [ + 3 + ], + "not excluded" + ] + } + }, + "NCT01717352": { + "inclusion": { + "0": [ + "The patient is 46 years old, which is within the age range of 21 to 65.", + [ + 0 + ], + "included" + ], + "1": [ + "The patient note does not provide information about the patient's BMI.", + [], + "not enough information" + ], + "2": [ + "The patient reports insomnia, which suggests she may sleep 7 hours or less most nights.", + [ + 0 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "There is no mention of the patient using medications affecting sleep.", + [], + "not enough information" + ], + "1": [ + "There is no mention of the patient having sleep apnea.", + [], + "not enough information" + ], + "2": [ + "There is no mention of the patient doing shift work.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-20157": { + "0": { + "NCT02633449": { + "inclusion": { + "0": [ + "The patient shows symptoms of depression but there is no direct diagnosis of unipolar major depressive disorder.", + [], + 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is 20 years old.", + [ + 0 + ], + "included" + ], + "2": [ + "No information about binge drinking episodes is provided.", + [], + "not enough information" + ], + "3": [ + "The patient shows symptoms of depression but no BDI-II score is provided.", + [ + 0, + 1, + 2 + ], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient does not meet criteria for substance dependence or abuse in the past six months.", + [], + "not excluded" + ], + "1": [ + "The patient does not have a diagnosis of bulimia, psychosis, or bipolar disorder.", + [], + "not excluded" + ], + "2": [ + "The patient has not received any psychosocial treatment for depression or substance abuse in the past month.", + [], + "not excluded" + ], + "3": [ + "The patient has not received CBT for depression and/or alcohol use in the previous 6 months.", + [], + "not excluded" + ], + "4": [ + "The patient is not receiving pharmacological treatment for depression or substance abuse.", + [], + "not excluded" + ], + "5": [ + "The patient has not discontinued an antidepressant medication less than 1 month ago.", + [], + "not excluded" + ], + "6": [ + "The patient does not meet criteria for severe depression or pose a serious suicide or homicide risk.", + [], + "not excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-20158": { + "0": { + "NCT00393913": { + "inclusion": { + "0": [ + "The patient experiences symptoms of OSA, including snoring and sleepiness.", + [ + 0, + 2 + ], + "included" + ], + "1": [ + "There is no information about the patient's medical history or medication changes.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient has symptoms consistent with OSA and no mention of other sleep disorders.", + [ + 0 + ], + "not excluded" + ], + "1": [ + "There is no mention of medically unstable health conditions.", + [], + "not enough information" + ], + "2": [ + "There is no mention of psychotropic medication use.", + [], + "not enough information" + ], + "3": [ + "There is no mention of drug or alcohol use.", + [], + "not enough information" + ], + "4": [ + "The patient is a 10-year-old boy, so pregnancy is not applicable.", + [ + 0 + ], + "not applicable" + ], + "5": [ + "The patient can provide informed consent and comply with the trial protocol.", + [ + 3 + ], + "not excluded" + ], + "6": [ + "There is no mention of visual, hearing, or cognitive impairment.", + [], + "not enough information" + ] + } + }, + "NCT02562040": { + "inclusion": { + "0": [ + "The patient has symptoms of sleep-disordered breathing but no direct evidence of a diagnosis of mild sleep-disordered breathing.", + [ + 0 + ], + "not enough information" + ], + "1": [ + "The patient has nighttime snoring and pauses in breathing, but no information on frequency or duration.", + [ + 0 + ], + "not enough information" + ], + "2": [ + "No information on polysomnogram results is provided.", + [], + "not enough information" + ], + "3": [ + "No information on tonsillar hypertrophy is provided.", + [], + "not enough information" + ], + "4": [ + "No information on ENT evaluation or candidacy for AT is provided.", + [], + "not enough information" + ], + "5": [ + "The primary indication for AT is not specified.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "No mention of previous tonsillectomy.", + [], + "not excluded" + ], + "1": [ + "No mention of recurrent tonsillitis.", + [], + "not excluded" + ], + "2": [ + "No information on BMI or obesity.", + [], + "not enough information" + ], + "3": [ + "No mention of failure to thrive.", + [], + "not excluded" + ], + "4": [ + "No mention of severe chronic health conditions.", + [], + "not excluded" + ], + "5": [ + "No mention of severe cardiopulmonary disorders.", + [], + "not excluded" + ], + "6": [ + "No mention of bleeding disorders.", + [], + "not excluded" + ], + "7": [ + "No mention of Sickle Cell Disease.", + [], + "not excluded" + ], + "8": [ + "No mention of epilepsy requiring medication.", + [], + "not excluded" + ], + "9": [ + "No mention of significant cardiac arrhythmia.", + [], + "not excluded" + ], + "10": [ + "No mention of other severe chronic health problems.", + [], + "not excluded" + ], + "11": [ + "No mention of genetic, craniofacial, neurological or psychiatric conditions.", + [], + "not excluded" + ], + "12": [ + "No mention of current use of psychotropic medication.", + [], + "not excluded" + ], + "13": [ + "No mention of autism spectrum disorder.", + [], + "not excluded" + ], + "14": [ + "No mention of intellectual deficit or self-contained classroom.", + [], + "not excluded" + ], + "15": [ + "No mention of severe developmental disability or ABAS-3 score.", + [], + "not excluded" + ], + "16": [ + "No mention of plans to move out of the area.", + [], + "not excluded" + ], + "17": [ + "No mention of being in foster care.", + [], + "not excluded" + ], + "18": [ + "No mention of language barriers.", + [], + "not excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-20159": { + "0": { + "NCT01766830": { + "inclusion": { + "0": [ + "The patient has had a fever for at least 1 week.", + [ + 1 + ], + "included" + ], + "1": [ + "The patient is 10 years old.", + [ + 0 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient will provide informed consent.", + [ + 6 + ], + "not excluded" + ], + "1": [ + "The patient will comply with the trial protocol.", + [ + 6 + ], + "not excluded" + ], + "2": [ + "There is no mention of an existing laboratory confirmed diagnosis.", + [], + "not excluded" + ], + "3": [ + "The patient shows signs of respiratory distress.", + [ + 0, + 3 + ], + "excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201510": { + "0": { + "NCT02340533": { + "inclusion": { + "0": [ + "The patient is a female with symptoms of dysmenorrhea, chronic pelvic pain, menorrhagia, and metrorrhagia.", + [ + 0 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient will provide informed consent and comply with the trial protocol.", + [ + 2 + ], + "not excluded" + ] + } + }, + "NCT01377519": { + "inclusion": { + "0": [ + "The patient is 38 years old, which is greater than 18 years.", + [ + 0 + ], + "included" + ], + "1": [ + "The patient is a premenopausal woman.", + [ + 0 + ], + "included" + ], + "2": [ + "The patient has symptoms that could be associated with fibroids, such as pelvic pain and heavy periods.", + [ + 0 + ], + "included" + ], + "3": [ + "There is no information about the accessibility of fibroids for focused ultrasound treatment.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient has a history of infertility treatment, but there is no mention of a desire for future fertility.", + [ + 1 + ], + "not excluded" + ], + "1": [ + "There is no mention of current pregnancy in the patient note.", + [], + "not excluded" + ], + "2": [ + "There is no information about the patient's hematocrit level.", + [], + "not enough information" + ], + "3": [ + "There is no mention of an emergency room visit for fibroid symptoms in the last 3 months.", + [], + "not excluded" + ], + "4": [ + "There is no mention of a history of venous thromboembolism.", + [], + "not excluded" + ], + "5": [ + "There is no information about the size or characteristics of the fibroids.", + [], + "not enough information" + ], + "6": [ + "There is no mention of adenomyosis in the patient note.", + [], + "not excluded" + ], + "7": [ + "There is no mention of contraindications to undergoing MRI.", + [], + "not excluded" + ], + "8": [ + "The patient has heavy, irregular periods and occasional spotting, which could indicate unexplained menstrual irregularity.", + [ + 0 + ], + "excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201511": { + "0": { + "NCT01862510": { + "inclusion": { + "0": [ + "The patient shows symptoms consistent with hypothyroidism but there is no direct evidence of a diagnosis or requirement for thyroid replacement therapy.", + [ + 0, + 1, + 2, + 3 + ], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "There is no mention of surgical resection of thyroid tissue, neck irradiation, radioactive iodine therapy, or prior medical treatment with the specified drugs in the patient note.", + [], + "not excluded" + ] + } + }, + "NCT01197183": { + "inclusion": { + "0": [ + "The patient shows symptoms consistent with hypothyroidism but there is no direct evidence of a recent diagnosis.", + [ + 0, + 1, + 2, + 3 + ], + "not enough information" + ], + "1": [ + "The patient will provide informed consent.", + [ + 4 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient will provide informed consent and comply with the trial protocol, indicating no recent clinical trial participation.", + [ + 4 + ], + "not excluded" + ], + "1": [ + "The patient will comply with the trial protocol without any practical issues, indicating no major risk of not being able to follow-up.", + [ + 4 + ], + "not excluded" + ], + "2": [ + "There is no information about contraindications to L\u00e9vothyrox in the patient note.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201512": { + "0": { + "NCT02418169": { + "inclusion": { + "0": [ + "The patient has a skull fracture but there is no information about GCS or craniofacial fracture.", + [ + 0 + ], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient was admitted to the hospital after the accident.", + [], + "not excluded" + ] + } + }, + "NCT02467309": { + "inclusion": { + "0": [ + "The patient has sudden onset of fever and neck stiffness, which are clinical manifestations of probable bacterial meningitis, but there is no information on cerebrospinal fluid examination.", + [ + 2, + 3 + ], + "not enough information" + ], + "1": [ + "The patient is not a child, so this criterion is not applicable.", + [], + "not applicable" + ] + }, + "exclusion": { + "0": [ + "The criterion is not relevant as the patient is not mentioned to have congenital immunodeficiency.", + [], + "not applicable" + ], + "1": [ + "The criterion is not relevant as the patient is not mentioned to have HIV.", + [], + "not applicable" + ], + "2": [ + "There is no information about long-term corticosteroid treatment in the patient note.", + [], + "not enough information" + ], + "3": [ + "There is no information about disorders in adrenal gland, pituitary gland, or hypothalamus in the patient note.", + [], + "not enough information" + ], + "4": [ + "There is no information about tuberculosis in the patient note.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201513": { + "0": { + "NCT00315042": { + "inclusion": { + "0": [ + "The patient is 5 years old, which is within the required age range.", + [ + 0 + ], + "included" + ], + "1": [ + "The patient presents with symptoms consistent with pharyngitis, but no specific mention of Streptococcus pyogenes.", + [ + 0, + 2 + ], + "not enough information" + ], + "2": [ + "There is no information about a rapid detection throat swab test for Group A streptococcal antigen.", + [], + "not enough information" + ], + "3": [ + "The patient has pain on swallowing and fever, which are consistent with the required symptoms.", + [ + 0 + ], + "included" + ], + "4": [ + "There is no mention of tonsil or pharyngeal erythema or exudate.", + [], + "not enough information" + ], + "5": [ + "There is no mention of cervical adenopathy.", + [], + "not enough information" + ], + "6": [ + "There is no mention of uvular edema.", + [], + "not enough information" + ], + "7": [ + "The patient has a fever.", + [ + 0 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient has symptoms like dysphagia, drooling, fever, and vocal changes, which do not suggest nonstreptococcal T/P.", + [ + 0, + 1, + 2 + ], + "not excluded" + ], + "1": [ + "There is no mention of a history of positive throat culture for Streptococcus pyogenes without clinical signs and symptoms.", + [], + "not enough information" + ], + "2": [ + "The patient presents with symptoms that could suggest epiglottitis, which is an infection of the deep tissues of the upper respiratory tract.", + [ + 0, + 1 + ], + "excluded" + ], + "3": [ + "There is no mention of a history of rheumatic heart disease.", + [], + "not enough information" + ], + "4": [ + "The patient is a 5-year-old boy, not a female of childbearing potential.", + [ + 0 + ], + "not applicable" + ], + "5": [ + "There is no mention of known congenital prolonged QT syndrome.", + [], + "not enough information" + ], + "6": [ + "There is no mention of known or suspected uncorrected hypokalemia, hypomagnesemia, or bradycardia.", + [], + "not enough information" + ], + "7": [ + "There is no mention of myasthenia gravis.", + [], + "not enough information" + ], + "8": [ + "There is no mention of known impaired renal function.", + [], + "not enough information" + ], + "9": [ + "There is no mention of the patient being treated with drugs not permitted by the study protocol.", + [], + "not enough information" + ], + "10": [ + "There is no mention of the patient being treated with systemic antibacterials or investigational medication recently.", + [], + "not enough information" + ], + "11": [ + "There is no mention of treatment with rifampicin, phenytoin, carbamazepine, or St. John's wort.", + [], + "not enough information" + ], + "12": [ + "There is no mention of hypersensitivity or intolerance to macrolides, penicillins, or cephalosporins.", + [], + "not enough information" + ], + "13": [ + "There is no mention of previous enrollment in this study or previous treatment with telithromycin.", + [], + "not enough information" + ], + "14": [ + "There is no mention of the patient being a child of the investigator or related to study staff.", + [], + "not enough information" + ] + } + }, + "NCT01255670": { + "inclusion": { + "0": [ + "The patient presents with symptoms that could suggest a peritonsillar abscess, but there is no mention of a doctor's suspicion.", + [ + 0 + ], + "not enough information" + ], + "1": [ + "The patient will provide informed consent and comply with the trial protocol.", + [ + 4 + ], + "included" + ], + "2": [ + "There is no information about the patient's access to email.", + [], + "not enough information" + ], + "3": [ + "There is no information about the patient's language skills.", + [], + "not enough information" + ], + "4": [ + "The patient is a 5-year-old boy, so this criterion is not applicable.", + [], + "not applicable" + ], + "5": [ + "There is no direct mention of a peritonsillar abscess diagnosis.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "No mention of penicillin allergy.", + [], + "not enough information" + ], + "1": [ + "No mention of metronidazole allergy.", + [], + "not enough information" + ], + "2": [ + "No mention of recent metronidazole use.", + [], + "not enough information" + ], + "3": [ + "The patient is a 5-year-old boy, not applicable.", + [ + 0 + ], + "not applicable" + ], + "4": [ + "The patient is a 5-year-old boy, not applicable.", + [ + 0 + ], + "not applicable" + ], + "5": [ + "No mention of renal insufficiency.", + [], + "not enough information" + ], + "6": [ + "No mention of liver insufficiency.", + [], + "not enough information" + ], + "7": [ + "The patient is a 5-year-old boy, not applicable.", + [ + 0 + ], + "not applicable" + ], + "8": [ + "No mention of participation in another clinical trial.", + [], + "not enough information" + ], + "9": [ + "No mention of in-patient care requirement.", + [], + "not enough information" + ], + "10": [ + "No mention of planned tonsillectomy.", + [], + "not enough information" + ], + "11": [ + "The patient is a 5-year-old boy, not applicable.", + [ + 0 + ], + "not applicable" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201514": { + "0": { + "NCT00827463": { + "inclusion": { + "0": [ + "The patient is at 11 weeks gestation in her second pregnancy, which is the beginning of pregnancy.", + [ + 0 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient note does not mention the language spoken by the patient.", + [], + "not enough information" + ], + "1": [ + "There is no mention of beta thalassemia in the patient note.", + [], + "not excluded" + ], + "2": [ + "The patient is receiving iron supplementation, which could be considered a periconceptional treatment against anemia.", + [ + 2 + ], + "excluded" + ] + } + }, + "NCT01308112": { + "inclusion": { + "0": [ + "The patient is a 27-year-old woman, which falls within the age range of 15-45 years.", + [ + 0 + ], + "included" + ], + "1": [ + "The patient is 11 weeks gestation in her second pregnancy, which is less than 23 weeks.", + [ + 0 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient note does not mention failure to provide a blood sample.", + [], + "not excluded" + ], + "1": [ + "The patient's initial haemoglobin concentration is 90 g/L.", + [ + 0 + ], + "not excluded" + ], + "2": [ + "There is no mention of sickle cell anaemia, epilepsy, or diabetes in the patient's medical history.", + [], + "not enough information" + ], + "3": [ + "There is no mention of eclampsia or pre-eclampsia in the obstetric history.", + [], + "not enough information" + ], + "4": [ + "There is no mention of mental retardation or metabolic disorder.", + [], + "not enough information" + ], + "5": [ + "The patient will provide informed consent.", + [ + 9 + ], + "not excluded" + ], + "6": [ + "The patient is in her second pregnancy, not carrying multiples.", + [ + 0 + ], + "not excluded" + ], + "7": [ + "There is no mention of the patient planning to leave the homestead or be absent for prolonged periods.", + [], + "not enough information" + ], + "8": [ + "There is no mention of the patient planning to deliver outside the research clinic.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201515": { + "0": { + "NCT00932425": { + "inclusion": { + "0": [ + "The patient is 72 years old, which is greater than 18.", + [ + 0 + ], + "included" + ], + "1": [ + "There is no information indicating the patient was seen at UCSF Medical Center.", + [], + "not enough information" + ], + "2": [ + "The patient had a cryptogenic stroke two weeks ago, which is within the previous 60 days.", + [ + 0 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "No evidence of small-vessel etiology by history or imaging.", + [ + 2 + ], + "not excluded" + ], + "1": [ + "No source found on vascular imaging of possible culprit vessels.", + [ + 2 + ], + "not excluded" + ], + "2": [ + "No source found by echocardiography.", + [ + 2 + ], + "not excluded" + ], + "3": [ + "No history of atrial fibrillation mentioned.", + [], + "not enough information" + ], + "4": [ + "No atrial fibrillation on admission ECG.", + [ + 3 + ], + "not excluded" + ], + "5": [ + "No atrial fibrillation detected by inpatient cardiac telemetry.", + [], + "not enough information" + ], + "6": [ + "No obvious culpable systemic illness such as endocarditis mentioned.", + [], + "not enough information" + ], + "7": [ + "Patient is able to provide informed consent.", + [ + 5 + ], + "not excluded" + ] + } + }, + "NCT01550588": { + "inclusion": { + "0": [ + "The patient had a cryptogenic stroke two weeks ago, radiologically verified.", + [ + 0, + 1 + ], + "included" + ], + "1": [ + "There is no mention of a high-risk PFO diagnosis in the patient note.", + [], + "not included" + ], + "2": [ + "The patient is willing to provide informed consent and comply with the trial protocol.", + [ + 5 + ], + "included" + ], + "3": [ + "No other potential causes of stroke are mentioned in the patient note.", + [ + 2 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "No identifiable cause of thromboembolic cause other than PFO is mentioned.", + [], + "not excluded" + ], + "1": [ + "No evidence of intracardiac thrombus, tumor, dilated cardiomyopathy, prosthetic heart valve, mitral stenosis, or endocarditis is mentioned.", + [], + "not excluded" + ], + "2": [ + "No evidence of significant atherosclerosis, dissection of the aorta, collagen vascular disease, arteritis, vasculitis, or coagulopathy is mentioned.", + [], + "not excluded" + ], + "3": [ + "No history of acute or recent myocardial infarction or unstable angina is mentioned.", + [], + "not excluded" + ], + "4": [ + "CT scan was negative for brain hemorrhage, suggesting no non-vascular origin of neurological symptoms.", + [ + 1 + ], + "not excluded" + ], + "5": [ + "No history of intracranial bleeding, confirmed arterio-venous malformation, aneurysm, or uncontrolled coagulopathy is mentioned.", + [], + "not excluded" + ], + "6": [ + "No pre-existing neurological disorders or intracranial disease are mentioned.", + [], + "not excluded" + ], + "7": [ + "No evidence of left ventricular aneurysm or akinesis is mentioned.", + [], + "not excluded" + ], + "8": [ + "Patient has normal sinus rhythm and no mention of atrial fibrillation or atrial flutter.", + [ + 3 + ], + "not excluded" + ], + "9": [ + "No other source of right to left shunt identified at baseline is mentioned.", + [], + "not excluded" + ], + "10": [ + "Patient underwent TEE examination.", + [ + 2 + ], + "not excluded" + ], + "11": [ + "No contraindication to aspirin or Clopidogrel therapy is mentioned.", + [], + "not excluded" + ], + "12": [ + "Patient is a 72-year-old woman, unlikely to be pregnant or desire pregnancy.", + [ + 0 + ], + "not excluded" + ], + "13": [ + "No underlying malignancy is mentioned.", + [], + "not excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201516": { + "0": { + "NCT00839124": { + "inclusion": { + "0": [ + "No information on lung function tests is provided.", + [], + "not enough information" + ], + "1": [ + "The patient's oxygen saturation is 100%, but no information on blood pressure is provided.", + [ + 7 + ], + "not enough information" + ], + "2": [ + "No information on symptom score is provided.", + [], + "not enough information" + ], + "3": [ + "No information on methacholine inhalation challenge is provided.", + [], + "not enough information" + ], + "4": [ + "The patient is male, so a pregnancy test is not applicable.", + [], + "not applicable" + ], + "5": [ + "No information on allergy skin test is provided.", + [], + "not enough information" + ], + "6": [ + "The patient has a history of wheezing at age 4, which is before age 6.", + [ + 0, + 1, + 3 + ], + "not included" + ], + "7": [ + "No information on a positive methacholine test is provided.", + [], + "not enough information" + ], + "8": [ + "No information on FEV1 or FEV1/FVC ratio is provided.", + [], + "not enough information" + ], + "9": [ + "No information on allergic sensitization to specific allergens is provided.", + [], + "not enough information" + ], + "10": [ + "No information on allergy skin test is provided.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient does not have any chronic medical conditions mentioned.", + [], + "not excluded" + ], + "1": [ + "The patient has not had physician directed emergency treatment for asthma in the past 12 months.", + [ + 1 + ], + "not excluded" + ], + "2": [ + "There is no mention of systemic steroid therapy use in the past 12 months.", + [], + "not excluded" + ], + "3": [ + "There is no mention of the use of inhaled steroids, cromolyn, or leukotriene inhibitors.", + [], + "not excluded" + ], + "4": [ + "There is no mention of the use of daily theophylline.", + [], + "not excluded" + ], + "5": [ + "There is no mention of the use of tricyclics and MAO inhibitors.", + [], + "not excluded" + ], + "6": [ + "The patient is a 4-year-old boy, so pregnancy or nursing is not applicable.", + [], + "not applicable" + ], + "7": [ + "There is no mention of cigarette smoking.", + [], + "not excluded" + ], + "8": [ + "There is no mention of nighttime symptoms of cough or wheeze greater than 1x/week.", + [], + "not excluded" + ], + "9": [ + "There is no mention of asthma exacerbations more than 2x/week.", + [], + "not excluded" + ], + "10": [ + "There is no mention of a daily requirement for albuterol.", + [], + "not excluded" + ], + "11": [ + "There is no mention of a viral upper respiratory tract infection within 2 weeks.", + [], + "not excluded" + ], + "12": [ + "There is no mention of any acute infection requiring antibiotics within 2 weeks.", + [], + "not excluded" + ], + "13": [ + "There is no mention of receipt of LAIV within the prior 14 days.", + [], + "not excluded" + ] + } + }, + "NCT00930826": { + "inclusion": { + "0": [ + "The patient has no history of wheezing and no clinical diagnosis of bronchial asthma.", + [ + 1 + ], + "not included" + ], + "1": [ + "There is no information about the patient's ability to swallow tablets.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "There is no mention of steroid inhalation or ingestion in the patient note.", + [], + "not excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201517": { + "0": { + "NCT01446198": { + "inclusion": { + "0": [ + "The patient note does not mention an APTIMA HPV Assay TIGRIS System result.", + [], + "not enough information" + ], + "1": [ + "The patient note does not mention if an aliquot is available and suitable for testing.", + [], + "not enough information" + ], + "2": [ + "The patient note does not mention if the sample was randomly selected for inclusion.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "There is no information about sample integrity in the patient note.", + [], + "not enough information" + ] + } + }, + "NCT01231945": { + "inclusion": { + "0": [ + "The patient has not been previously diagnosed with cervical cancer.", + [ + 0 + ], + "included" + ], + "1": [ + "The patient is female and likely has a cervix.", + [ + 0 + ], + "included" + ], + "2": [ + "There is no information about the patient's pregnancy status.", + [], + "not enough information" + ], + "3": [ + "The patient is physically able to undergo routine cervical cancer screening.", + [ + 1 + ], + "included" + ], + "4": [ + "The patient is able to provide informed consent.", + [ + 3 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient is married or has had sexual intercourse and has not had a total hysterectomy.", + [], + "not excluded" + ], + "1": [ + "The patient has no history of cervical cancer.", + [ + 0 + ], + "not excluded" + ], + "2": [ + "The patient is able to provide informed consent and undergo routine cervical cancer screening.", + [ + 3 + ], + "not excluded" + ], + "3": [ + "There is no information about the patient's pregnancy status.", + [], + "not enough information" + ], + "4": [ + "There is no information about the patient's menstruation status.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201518": { + "0": { + "NCT00344513": { + "inclusion": { + "0": [ + "The patient has significant heart failure symptoms but there is no information about hospitalization.", + [ + 0, + 1, + 2 + ], + "not enough information" + ], + "1": [ + "The patient has heart failure symptoms but there is no information about systolic or diastolic dysfunction.", + [ + 0, + 1, + 2 + ], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "There are no exclusion criteria for this study.", + [], + "not applicable" + ] + } + }, + "NCT00534066": { + "inclusion": { + "0": [ + "The patient is 65 years old.", + [ + 0 + ], + "included" + ], + "1": [ + "The patient shows symptoms consistent with CHF but no direct evidence of a primary diagnosis in the ED.", + [], + "not enough information" + ], + "2": [ + "There is no information about hospital admission or transfer to the Observation Unit.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient is able to provide informed consent.", + [ + 3 + ], + "not excluded" + ], + "1": [ + "There is no mention of unstable angina or acute myocardial infarction in the ED.", + [], + "not enough information" + ], + "2": [ + "There is no mention of the patient being dialysis dependent.", + [], + "not enough information" + ], + "3": [ + "There is no mention of the use of nesiritide as a therapy in the ED.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201519": { + "0": { + "NCT00806091": { + "inclusion": { + "0": [ + "The patient has a significant smoking history and symptoms consistent with COPD.", + [ + 0, + 3 + ], + "included" + ], + "1": [ + "The patient is a smoker, not a non-smoker.", + [ + 3 + ], + "not included" + ] + }, + "exclusion": {} + }, + "NCT02213809": { + "inclusion": { + "0": [ + "The criterion is not applicable to the patient as it pertains to the characteristics of the health care centers, not individual patients.", + [], + "not applicable" + ], + "1": [ + "The patient likely has COPD due to smoking history and symptoms, but there is no direct evidence of a COPD diagnosis or spirometry results indicating GOLD grade 2-3.", + [ + 0, + 2, + 3 + ], + "not enough information" + ] + }, + "exclusion": {} + } + }, + "1": {}, + "2": {} + }, + "sigir-201520": { + "0": { + "NCT00880347": { + "inclusion": { + "0": [ + "The patient is male and aged 89 years old.", + [ + 0 + ], + "included" + ], + "1": [ + "There is no direct evidence of a clinical diagnosis of probable AD according to DSM-IV TR and NINCDS-ADRDA criteria.", + [], + "not enough information" + ], + "2": [ + "The patient will provide informed consent.", + [ + 13 + ], + "included" + ], + "3": [ + "No evidence of brain imaging performed to settle AD diagnosis.", + [], + "not enough information" + ], + "4": [ + "Neurological exam shows paratonic rigidity and myoclonic jerks, which are specific focal signs.", + [ + 10, + 11 + ], + "not included" + ], + "5": [ + "The patient will comply with the trial protocol.", + [ + 13 + ], + "included" + ], + "8": [ + "The patient is male and aged 89 years old.", + [ + 0 + ], + "included" + ], + "9": [ + "There is no direct evidence of a clinical diagnosis of dementia according to specified criteria.", + [], + "not enough information" + ], + "15": [ + "The patient will provide informed consent.", + [ + 13 + ], + "included" + ], + "16": [ + "No evidence of brain imaging performed to settle dementia diagnosis.", + [], + "not enough information" + ], + "17": [ + "Neurological exam shows paratonic rigidity and myoclonic jerks, which may relate to other conditions.", + [ + 10, + 11 + ], + "not included" + ], + "18": [ + "The patient will comply with the trial protocol.", + [ + 13 + ], + "included" + ], + "20": [ + "The patient is aged 89 years old.", + [ + 0 + ], + "included" + ], + "21": [ + "The patient will provide informed consent.", + [ + 13 + ], + "included" + ], + "22": [ + "The patient has significant cognitive complaints.", + [ + 0, + 1 + ], + "not included" + ], + "23": [ + "No MMSE score provided.", + [], + "not enough information" + ], + "24": [ + "The patient has impairment in daily living activities.", + [ + 2 + ], + "not included" + ], + "25": [ + "The patient will comply with the trial protocol.", + [ + 13 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient has symptoms that may lead to reconsider the initial diagnosis of probable AD.", + [ + 0, + 1, + 2, + 4, + 7 + ], + "excluded" + ], + "1": [ + "No evidence of drug or alcohol abuse or dependence.", + [], + "not excluded" + ], + "2": [ + "The patient has significant cognitive impairment affecting daily living activities.", + [ + 0, + 1, + 2 + ], + "not excluded" + ], + "3": [ + "No evidence of a current diagnosis of brain tumour.", + [], + "not excluded" + ], + "4": [ + "No evidence of a condition making blood sampling risky.", + [], + "not excluded" + ], + "5": [ + "The patient is male, so pregnancy is not applicable.", + [], + "not applicable" + ], + "6": [ + "No information about registration at S\u00e9curit\u00e9 Sociale.", + [], + "not enough information" + ], + "7": [ + "No information about participation in another study.", + [], + "not enough information" + ], + "9": [ + "The patient has symptoms that may lead to reconsider the initial diagnosis of dementia.", + [ + 0, + 1, + 2, + 4, + 7 + ], + "excluded" + ], + "10": [ + "The patient has significant cognitive impairment affecting daily living activities.", + [ + 0, + 1, + 2 + ], + "not excluded" + ], + "11": [ + "No evidence of a current diagnosis of brain tumour.", + [], + "not excluded" + ], + "12": [ + "No evidence of a condition making blood sampling risky.", + [], + "not excluded" + ], + "13": [ + "No evidence of drug or alcohol abuse or dependence.", + [], + "not excluded" + ], + "14": [ + "The patient is male, so pregnancy is not applicable.", + [], + "not applicable" + ], + "15": [ + "No information about registration at S\u00e9curit\u00e9 Sociale.", + [], + "not enough information" + ], + "16": [ + "No information about participation in another study.", + [], + "not enough information" + ], + "18": [ + "The patient has significant cognitive impairment.", + [ + 0, + 1, + 2 + ], + "excluded" + ], + "19": [ + "No information about family history of dementia.", + [], + "not enough information" + ], + "20": [ + "The patient has a diagnosis of dementia.", + [ + 0, + 1, + 2 + ], + "excluded" + ], + "21": [ + "No evidence of clinically significant psychiatric pathology.", + [], + "not excluded" + ], + "22": [ + "No evidence of major depressive disorder.", + [], + "not excluded" + ], + "23": [ + "No evidence of a condition making blood sampling risky.", + [], + "not excluded" + ], + "24": [ + "No evidence of recent clinically significant pathology.", + [], + "not excluded" + ], + "25": [ + "No evidence of drug or alcohol abuse or dependence.", + [], + "not excluded" + ], + "26": [ + "No information about registration at S\u00e9curit\u00e9 Sociale.", + [], + "not enough information" + ], + "27": [ + "No information about participation in another study.", + [], + "not enough information" + ] + } + }, + "NCT00182832": { + "inclusion": { + "0": [ + "The patient is 89 years old.", + [ + 0 + ], + "included" + ], + "1": [ + "The patient note does not mention hospitalization in a medical ward.", + [], + "not enough information" + ], + "2": [ + "The patient is able to speak and express himself, indicating he can speak English.", + [ + 1, + 8 + ], + "included" + ], + "3": [ + "The patient shows signs of cognitive impairment.", + [ + 0, + 1, + 4, + 7, + 9 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "There is no information indicating the patient was previously enrolled in the study.", + [], + "not excluded" + ], + "1": [ + "There is no information indicating the patient is enrolled in another clinical trial.", + [], + "not excluded" + ], + "2": [ + "The patient has cognitive impairment as evidenced by memory issues and inability to perform daily activities.", + [ + 0, + 1, + 2, + 7 + ], + "not excluded" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201521": { + "0": { + "NCT02105714": { + "inclusion": { + "0": [ + "The patient has diarrhea but there is no information on the duration.", + [ + 0 + ], + "not enough information" + ], + "1": [ + "The patient will provide informed consent.", + [ + 5 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "No evidence of need for immediate intensive or surgical care.", + [], + "not excluded" + ], + "1": [ + "The patient will provide informed consent.", + [ + 5 + ], + "not excluded" + ], + "2": [ + "No evidence of clinical jaundice.", + [], + "not excluded" + ], + "3": [ + "The patient will comply with the trial protocol.", + [ + 5 + ], + "not excluded" + ], + "4": [ + "No evidence of participation in other ongoing studies.", + [], + "not excluded" + ] + } + }, + "NCT01959048": { + "inclusion": { + "0": [ + "The patient is male, and both genders are eligible.", + [ + 0 + ], + "included" + ], + "1": [ + "The patient is 32 years old, which is 18 years or older.", + [ + 0 + ], + "included" + ], + "2": [ + "The patient will provide informed consent.", + [ + 5 + ], + "included" + ], + "3": [ + "There is no confirmed diagnosis of severe CDAD in the patient note.", + [], + "not included" + ] + }, + "exclusion": { + "0": [ + "The patient is not pregnant or lactating as he is male.", + [ + 0 + ], + "not applicable" + ], + "1": [ + "There is no mention of the need for prolonged antibiotics for other causes.", + [], + "not enough information" + ], + "2": [ + "The patient has an etiology for diarrhea due to drinking water from natural sources, likely Giardia.", + [ + 3, + 4 + ], + "excluded" + ], + "3": [ + "There is no mention of active, chronic conditions such as IBD, Crohn's, etc.", + [], + "not enough information" + ], + "4": [ + "There is no mention of laxative or motility-altering drug use.", + [], + "not enough information" + ], + "5": [ + "There is no mention of clinical instability or hemodynamic instability.", + [], + "not enough information" + ], + "6": [ + "There is no mention of any condition precluding safe participation.", + [], + "not enough information" + ], + "7": [ + "There is no mention of immune suppression, HIV, or recent chemotherapy.", + [], + "not enough information" + ], + "8": [ + "There is no mention of prior colon surgery.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201522": { + "0": { + "NCT02534727": { + "inclusion": { + "0": [ + "The patient is 65 years old.", + [ + 0 + ], + "included" + ], + "1": [ + "The patient has a history of tuberculosis.", + [ + 0 + ], + "included" + ], + "2": [ + "The patient has ongoing symptoms of pulmonary TB, such as a productive cough with tinges of blood.", + [ + 0 + ], + "included" + ], + "3": [ + "There is no information about suspected drug resistance.", + [], + "not enough information" + ], + "4": [ + "The patient is likely able to provide sputum samples as he has a productive cough.", + [ + 0 + ], + "included" + ], + "5": [ + "There is no information about the patient taking anti-tuberculosis medicines.", + [], + "not enough information" + ], + "6": [ + "The patient is likely Mycobacterium culture positive as the sputum culture revealed an organism with septated, low-angle branching hyphae.", + [ + 3 + ], + "included" + ], + "7": [ + "This criterion is not applicable as it is specific to China subjects.", + [], + "not applicable" + ], + "8": [ + "The patient is likely able to produce sputum samples as he has a productive cough.", + [ + 0 + ], + "included" + ], + "9": [ + "The patient is willing to provide blood samples as he will comply with the trial protocol.", + [ + 4 + ], + "included" + ], + "10": [ + "The patient is willing to have samples stored as he will comply with the trial protocol.", + [ + 4 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "No mention of acute liver or kidney disease in the patient note.", + [], + "not excluded" + ], + "1": [ + "No evidence of conditions compromising the ability to take or absorb oral drugs.", + [], + "not excluded" + ] + } + }, + "NCT01207128": { + "inclusion": { + "0": [ + "The patient will provide informed consent.", + [ + 4 + ], + "included" + ], + "1": [ + "Assent requirement is not applicable to this adult patient.", + [], + "not applicable" + ], + "2": [ + "The patient has a diagnosis of aspergillosis but no information on GM index or antibiotic use.", + [ + 3 + ], + "not enough information" + ], + "3": [ + "The patient is 65 years old.", + [ + 0 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "No evidence the patient is being treated with an unlicensed investigational drug for aspergillosis.", + [], + "not excluded" + ], + "1": [ + "No information on prior antifungal treatment duration.", + [], + "not enough information" + ], + "2": [ + "No information on Aspergillus GM index.", + [], + "not enough information" + ], + "3": [ + "The patient is male, so pregnancy-related criteria are not applicable.", + [], + "not applicable" + ], + "4": [ + "No information on liver function tests.", + [], + "not enough information" + ], + "5": [ + "No information on hepatic cirrhosis.", + [], + "not enough information" + ], + "6": [ + "No information on creatinine levels or ability to receive oral voriconazole.", + [], + "not enough information" + ], + "7": [ + "No information on artificial ventilation.", + [], + "not enough information" + ], + "8": [ + "No information on allergy or hypersensitivity to antifungal agents.", + [], + "not enough information" + ], + "9": [ + "No information on previous enrollment in the study.", + [], + "not enough information" + ], + "10": [ + "No information on concomitant medical conditions creating additional risk.", + [], + "not enough information" + ], + "11": [ + "No evidence of a non-Aspergillus mold infection.", + [], + "not excluded" + ], + "12": [ + "No information on life expectancy.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201523": { + "0": { + "NCT00084240": { + "inclusion": { + "0": [ + "The patient is 18 years old and has symptoms like high fever, but there is no evidence of a positive blood smear for Plasmodium falciparum.", + [ + 0 + ], + "not enough information" + ], + "1": [ + "There is no information about the patient's serum glucose level.", + [], + "not enough information" + ], + "2": [ + "There is no information about a positive rapid diagnostic test for P. falciparum.", + [], + "not enough information" + ], + "3": [ + "The criterion is not applicable as the patient is male.", + [], + "not applicable" + ] + }, + "exclusion": { + "0": [ + "The patient does not show signs of severe or complicated malaria as per the criteria listed.", + [], + "not excluded" + ], + "1": [ + "The patient is male, so this criterion is not applicable.", + [], + "not applicable" + ], + "2": [ + "There is no mention of any allergy or hypersensitivity to the drugs listed.", + [], + "not enough information" + ], + "3": [ + "The patient has leukopenia and thrombocytopenia.", + [ + 1 + ], + "excluded" + ], + "4": [ + "There is no mention of epilepsy or psoriasis.", + [], + "not enough information" + ], + "5": [ + "There is no mention of recent antimalarial or antibacterial treatment.", + [], + "not enough information" + ], + "6": [ + "There is no mention of cardiovascular, hepatic, or renal abnormalities.", + [], + "not enough information" + ], + "7": [ + "There is no mention of inability to swallow oral medication.", + [], + "not enough information" + ], + "8": [ + "There is no mention of treatment with investigational drugs.", + [], + "not enough information" + ], + "9": [ + "There is no mention of alcohol or drug abuse.", + [], + "not enough information" + ], + "10": [ + "There is no mention of requirement to use interfering medication.", + [], + "not enough information" + ], + "11": [ + "There is no mention of specific systemic diseases or conditions.", + [], + "not enough information" + ], + "12": [ + "The patient will comply with the trial protocol.", + [ + 2 + ], + "not excluded" + ], + "13": [ + "There is no mention of intentions to leave the vicinity.", + [], + "not enough information" + ], + "14": [ + "There is no mention of prior participation in this study.", + [], + "not enough information" + ] + } + }, + "NCT02334514": { + "inclusion": { + "0": [ + "The patient has symptoms such as sudden onset of high fever, headache, and joint pain, which suggest influenza virus infection.", + [ + 0 + ], + "included" + ], + "1": [ + "There is no information about a positive PCR test for influenza virus.", + [], + "not enough information" + ], + "2": [ + "There is no information about whether antiviral treatment was indicated.", + [], + "not enough information" + ] + }, + "exclusion": { + "0": [ + "The patient is not immune compromised as there is no mention of solid organ transplant, bone marrow transplantation, immune deficiency, or chronic immunosuppressive drug use.", + [], + "not excluded" + ], + "1": [ + "The patient is male, so this criterion is not applicable.", + [ + 0 + ], + "not applicable" + ], + "2": [ + "There is no information about prior treatment with oseltamivir in the patient note.", + [], + "not enough information" + ] + } + } + }, + "1": {}, + "2": {} + }, + "sigir-201524": { + "0": { + "NCT00540072": { + "inclusion": { + "0": [ + "The patient will provide informed consent.", + [ + 6 + ], + "included" + ], + "1": [ + "The patient is an adult male, 31 years old.", + [ + 0 + ], + "included" + ], + "2": [ + "No information about a chest radiograph is provided.", + [], + "not enough information" + ], + "3": [ + "The patient exhibits cough.", + [ + 0, + 1 + ], + "included" + ], + "4": [ + "The patient has a productive cough.", + [ + 0 + ], + "included" + ], + "5": [ + "The patient has egophany in the left lower lung field.", + [ + 5 + ], + "included" + ], + "6": [ + "No information about dyspnea or tachypnea is provided.", + [], + "not enough information" + ], + "7": [ + "The patient has a documented fever with a temperature of 103.4.", + [ + 4 + ], + "included" + ], + "8": [ + "No information about white blood cell count is provided.", + [], + "not enough information" + ], + "9": [ + "No information about hypoxemia is provided.", + [], + "not enough information" + ], + "10": [ + "No information about hospitalization or intravenous therapy is provided.", + [], + "not enough information" + ], + "11": [ + "The patient is willing to participate in the study.", + [ + 6 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "No information on Fine Score or Grade V pneumonia.", + [], + "not enough information" + ], + "1": [ + "No evidence of respiratory failure or need for mechanical ventilation.", + [], + "not excluded" + ], + "2": [ + "No specific pulmonary conditions mentioned.", + [], + "not enough information" + ], + "3": [ + "No mention of cystic fibrosis.", + [], + "not excluded" + ], + "4": [ + "No mention of primary lung cancer or metastasis.", + [], + "not excluded" + ], + "5": [ + "No known bronchial obstruction or history of post-obstructive pneumonia mentioned.", + [], + "not excluded" + ], + "6": [ + "No mention of active tuberculosis.", + [], + "not excluded" + ], + "7": [ + "Blood pressure is normal, no severe shock.", + [ + 4 + ], + "not excluded" + ], + "8": [ + "No mention of bacterial meningitis or lumbar puncture results.", + [], + "not excluded" + ], + "9": [ + "No information on renal impairment or creatinine clearance.", + [], + "not enough information" + ], + "10": [ + "No indication of moribund condition or high likelihood of death.", + [], + "not excluded" + ], + "11": [ + "No mention of HIV status or CD4 counts.", + [], + "not enough information" + ], + "12": [ + "No mention of allergy to beta-lactam antibiotics.", + [], + "not excluded" + ], + "13": [ + "No information on prior treatment with anti-infective agents or investigational drugs.", + [], + "not enough information" + ], + "14": [ + "No mention of HMG-CoA reductase inhibitor therapy.", + [], + "not excluded" + ], + "15": [ + "No anticipation of needing a second non-protocol antibiotic mentioned.", + [], + "not excluded" + ], + "16": [ + "No mention of induction chemotherapy or severe neutropenia.", + [], + "not excluded" + ], + "17": [ + "Patient is considered reliable to comply with study procedures.", + [ + 6 + ], + "not excluded" + ], + "18": [ + "No mention of progressive neoplastic disease.", + [], + "not excluded" + ], + "19": [ + "Patient is male, not applicable.", + [], + "not applicable" + ], + "20": [ + "No mention of nosocomial pneumonia or recent discharge from a facility.", + [], + "not excluded" + ], + "21": [ + "No clinical suspicion of Legionella pneumonia mentioned.", + [], + "not excluded" + ] + } + }, + "NCT00711399": { + "inclusion": { + "0": [ + "The patient will provide informed consent.", + [ + 6 + ], + "included" + ], + "1": [ + "The patient has a productive cough.", + [ + 0 + ], + "included" + ] + }, + "exclusion": { + "0": [ + "The patient does not have chest tubes.", + [], + "not excluded" + ], + "1": [ + "There is no mention of skin lesions precluding attachment of sensors.", + [], + "not excluded" + ], + "2": [ + "The patient does not show signs of respiratory distress.", + [ + 4, + 5 + ], + "not excluded" + ], + "3": [ + "The patient is male, so pregnancy is not applicable.", + [ + 0 + ], + "not applicable" + ] + } + } + }, + "1": {}, + "2": {} + } +} \ No newline at end of file diff --git a/results/retrieval_keywords_gpt-4o_sigir.json b/results/retrieval_keywords_gpt-4o_sigir.json new file mode 100644 index 0000000..4124bcb --- /dev/null +++ b/results/retrieval_keywords_gpt-4o_sigir.json @@ -0,0 +1,634 @@ +{ + "sigir-20141": { + "summary": "A 58-year-old African-American woman presents with episodic anterior chest pain radiating to the back, accompanied by nausea, diaphoresis, and mild dyspnea. She has a history of hypertension and obesity but denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. The EKG shows nonspecific changes.", + "conditions": [ + "Chest Pain", + "Hypertension", + "Obesity", + "Nausea", + "Diaphoresis", + "Dyspnea", + "African-American Ethnicity" + ] + }, + "sigir-20142": { + "summary": "An 8-year-old male presents with fever, dyspnea, and cough after returning from a vacation in Colorado. He is in respiratory distress with bronchial sounds on the left and bilateral lung infiltrates on chest x-ray. Prior to respiratory symptoms, he experienced loose stools.", + "conditions": [ + "Fever", + "Dyspnea", + "Cough", + "Respiratory Distress", + "Bronchial Breath Sounds", + "Bilateral Lung Infiltrates", + "Diarrhea" + ] + }, + "sigir-20143": { + "summary": "A 58-year-old nonsmoking white female presents with mild exertional dyspnea and occasional cough. Imaging reveals a left lung mass and a solitary mass in the right frontal lobe. She is otherwise asymptomatic and has an unremarkable neurologic examination.", + "conditions": [ + "Left Lung Mass", + "Solitary Brain Mass", + "Exertional Dyspnea", + "Cough" + ] + }, + "sigir-20144": { + "summary": "A 2-year-old boy presents with 5 days of high fever, irritability, conjunctivitis, strawberry tongue, inflammation and desquamation of the hands and feet, and cervical lymphadenopathy. He has abdominal tenderness, an enlarged liver, and laboratory findings of elevated alanine aminotransferase, leukocytosis, hypoalbuminemia, elevated C-reactive protein, elevated erythrocyte sedimentation rate, mild anemia, and sterile pyuria. Echocardiogram reveals moderate dilation of the coronary arteries with possible aneurysm.", + "conditions": [ + "Kawasaki Disease", + "Coronary Artery Aneurysm", + "Conjunctivitis", + "Strawberry Tongue", + "Cervical Lymphadenopathy", + "Hepatomegaly", + "Leukocytosis", + "Hypoalbuminemia", + "Elevated C-reactive Protein", + "Elevated Erythrocyte Sedimentation Rate", + "Normochromic Normocytic Anemia", + "Sterile Pyuria", + "Desquamation of Skin", + "Fever", + "Irritability" + ] + }, + "sigir-20145": { + "summary": "A 56-year-old female, 20 days post-left mastectomy, presents with shortness of breath and malaise. She has been bedridden for two weeks. Physical examination shows tenderness on the left upper thoracic wall and right calf, with decreased breath sounds bilaterally, especially at the right base. Elevated D-dimer is noted.", + "conditions": [ + "Post-mastectomy", + "Shortness of breath", + "Malaise", + "Prolonged bed rest", + "Tenderness of thoracic wall", + "Calf tenderness", + "Decreased breath sounds", + "Elevated D-dimer", + "Risk of deep vein thrombosis", + "Risk of pulmonary embolism" + ] + }, + "sigir-20146": { + "summary": "The patient is a 64-year-old obese female with Type 2 Diabetes and persistently elevated HbA1c levels. She is non-compliant with her diabetes management, including medication and exercise, and is reluctant to seek nutritional advice. She has a painful, enlarging, and oozing skin lesion on her left lower leg that has not responded to topical treatments.", + "conditions": [ + "Type 2 Diabetes", + "Obesity", + "Non-compliance with medication", + "Non-compliance with exercise", + "Chronic skin ulcer", + "Elevated HbA1c" + ] + }, + "sigir-20147": { + "summary": "The patient is a 26-year-old obese woman with a history of bipolar disorder, experiencing depression, anxiety, and agitation. She reports difficulty sleeping, suicidal thoughts, and increased irritability. Her current medications include lithium carbonate and zolpidem.", + "conditions": [ + "Bipolar Disorder", + "Obesity", + "Depression", + "Anxiety", + "Insomnia", + "Suicidal Ideation", + "Agitation", + "Irritability" + ] + }, + "sigir-20148": { + "summary": "The patient is a 62-year-old man experiencing progressive memory loss and jerking movements of the lower extremities. Neurologic examination reveals severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves, and neuroimaging indicates moderately advanced cerebral atrophy. A cortical biopsy reveals diffuse vacuolar changes of the gray matter with reactive astrocytosis.", + "conditions": [ + "Progressive Memory Loss", + "Myoclonus", + "Severe Cognitive Deficits", + "Memory Dysfunction", + "Generalized Periodic Sharp Waves on EEG", + "Cerebral Atrophy", + "Diffuse Vacuolar Changes of the Gray Matter", + "Reactive Astrocytosis" + ] + }, + "sigir-20149": { + "summary": "The patient is a 43-year-old woman presenting with multiple lesions on her neck. The lesions are small, soft, and pedunculated, with the largest being 4 mm in diameter. The color of the lesions ranges from flesh-colored to slightly hyperpigmented.", + "conditions": [ + "Skin Lesions", + "Acrochordon" + ] + }, + "sigir-201410": { + "summary": "The patient is a 67-year-old woman who underwent cardiac catheterization via the right femoral artery. She is experiencing a cool right foot, a pulsatile mass in the right groin, and loss of distal pulses. A bruit is heard over the entry point of the right femoral artery.", + "conditions": [ + "Post-Cardiac Catheterization Complication", + "Femoral Artery Pseudoaneurysm", + "Peripheral Arterial Occlusion", + "Vascular Bruit", + "Ischemic Limb" + ] + }, + "sigir-201411": { + "summary": "A 40-year-old woman with no past medical history presents with severe right arm pain, tachypnea, tachycardia, and hypotension. She denies any trauma, and her right arm shows no discoloration or movement limitation. She is pale and in moderate discomfort.", + "conditions": [ + "Acute Pain", + "Tachycardia", + "Tachypnea", + "Hypotension", + "Pallor" + ] + }, + "sigir-201412": { + "summary": "A 25-year-old woman presents with prolonged fatigue, hair loss, voice changes, weight gain, and cold intolerance over the past 6 months. She has a prominent, soft, uniform anterior cervical mass at the midline. She denies difficulty sleeping and sleeps an average of 8 hours a night.", + "conditions": [ + "Hypothyroidism", + "Goiter", + "Fatigue", + "Alopecia", + "Weight Gain", + "Cold Intolerance" + ] + }, + "sigir-201413": { + "summary": "A 30-year-old woman with a recent childbirth presents with acute shortness of breath, tachypnea, and tachycardia. She has a history of two natural abortions but no other significant past health issues. Her vital signs show mild hypoxemia with an oxygen saturation of 92%, but her chest x-ray and CBC are normal.", + "conditions": [ + "Postpartum Dyspnea", + "Tachypnea", + "Tachycardia", + "Hypoxemia", + "Recent Childbirth" + ] + }, + "sigir-201414": { + "summary": "An 85-year-old man presents with a gradual decrease in consciousness over the past few days, accompanied by a loss of ability to walk and eat independently. He has no fever, cough, rash, or diarrhea. He was involved in a car accident three weeks ago, but a head CT at that time was normal.", + "conditions": [ + "Decreased Consciousness", + "Loss of Mobility", + "Anorexia", + "History of Recent Trauma" + ] + }, + "sigir-201415": { + "summary": "A 36-year-old woman presents with 12 weeks of amenorrhea, increased vaginal spotting, lower abdominal tenderness, and nausea. Physical examination shows an 18-week sized uterus and cervical dilation. A negative pregnancy test and ultrasound findings suggest a differential diagnosis of vesicular mole versus fibroid degeneration.", + "conditions": [ + "Amenorrhea", + "Vaginal Spotting", + "Lower Abdominal Tenderness", + "Nausea", + "Vomiting", + "Cervical Dilation", + "Enlarged Uterus", + "Vesicular Mole", + "Fibroid Degeneration" + ] + }, + "sigir-201416": { + "summary": "The patient is a 28-year-old female experiencing neck and shoulder pain, left hand and arm paresthesias, and slight tremors. She developed spastic arm movements, sweating, agitation, anxiety, malaise, difficulty swallowing, and marked hydrophobia after returning from a trip. She was hospitalized with these symptoms.", + "conditions": [ + "Paresthesia", + "Tremor", + "Spasticity", + "Agitation", + "Anxiety", + "Malaise", + "Dysphagia", + "Hydrophobia", + "Rabies" + ] + }, + "sigir-201417": { + "summary": "The patient is a 48-year-old white male with a history of common variable immunodeficiency (CVID) presenting with acute abdominal pain, fever, and signs of shock. Physical examination and imaging revealed hepatomegaly and free intraperitoneal fluid, leading to the discovery of a ruptured liver abscess during exploratory laparotomy. The abscess was surgically drained, and the patient was admitted to the ICU post-surgery.", + "conditions": [ + "Common Variable Immunodeficiency", + "Ruptured Liver Abscess", + "Hepatomegaly", + "Acute Abdominal Pain", + "Fever", + "Hypotension", + "Tachycardia", + "Dehydration", + "Positive Murphy Sign", + "Free Intraperitoneal Fluid" + ] + }, + "sigir-201418": { + "summary": "The 6-month-old male infant is experiencing oliguria with urine output less than 0.2 mL/kg/hr following major surgery. He presents with generalized edema, elevated blood pressure, and abnormal laboratory findings including elevated blood urea nitrogen and serum creatinine levels. Urinalysis reveals hematuria, granular casts, and a high fractional excretion of sodium, suggesting acute kidney injury.", + "conditions": [ + "Oliguria", + "Generalized Edema", + "Hypertension", + "Tachycardia", + "Acute Kidney Injury", + "Hematuria", + "Granular Casts in Urine", + "Elevated Blood Urea Nitrogen", + "Elevated Serum Creatinine", + "High Fractional Excretion of Sodium", + "Postoperative Complications" + ] + }, + "sigir-201419": { + "summary": "The patient is a 52-year-old African American man with a history of heavy smoking and drinking, experiencing progressive dysphagia over several months. Initially, he had difficulty swallowing meat, which progressed to other solids, soft foods, and liquids. He reports a sensation of obstruction at the lower end of his sternum and has lost 25 pounds.", + "conditions": [ + "Dysphagia", + "Esophageal Obstruction", + "Weight Loss", + "History of Heavy Smoking", + "History of Heavy Alcohol Use" + ] + }, + "sigir-201420": { + "summary": "A 32-year-old woman involved in a car accident has sustained multiple fractures in her upper and lower extremities. She is alert but presents with a tender abdomen, guarding, rebound tenderness, and absent bowel sounds, indicating potential internal injuries. Her vital signs are stable with a blood pressure of 134/74 mm Hg and a pulse of 87/min.", + "conditions": [ + "Multiple fractures", + "Abdominal tenderness", + "Guarding", + "Rebound tenderness", + "Absent bowel sounds", + "Potential internal injuries" + ] + }, + "sigir-201421": { + "summary": "The patient is a 21-year-old female presenting with progressive joint pain, fatigue, hair loss, and a facial rash. She exhibits a non-palpable purpura on her calves and swelling in her wrists and ankles. Laboratory findings reveal normocytic anemia, thrombocytopenia, positive ANA and anti-dsDNA, and urine abnormalities including proteinuria and RBC casts.", + "conditions": [ + "Systemic Lupus Erythematosus", + "Arthralgia", + "Alopecia", + "Malar Rash", + "Purpura", + "Anemia", + "Thrombocytopenia", + "Proteinuria", + "Hematuria", + "Nephritis" + ] + }, + "sigir-201422": { + "summary": "A 15-year-old girl presents with abdominal pain that started periumbilically and localized to the right lower quadrant. She has had no appetite since yesterday and exhibits localized rebound tenderness in the right lower quadrant. An abdominal ultrasound shows a markedly edematous appendix.", + "conditions": [ + "Appendicitis", + "Abdominal Pain", + "Rebound Tenderness", + "Anorexia" + ] + }, + "sigir-201423": { + "summary": "The patient is a 63-year-old man with a history of heavy smoking, presenting with cough, shortness of breath, and cyanosis. He has a past medical history of spinal stenosis, Type 2 Diabetes, hypothyroidism, and mild psoriasis. His symptoms include productive cough and difficulty breathing, with a chest x-ray showing hyperinflation, suggesting possible chronic obstructive pulmonary disease (COPD).", + "conditions": [ + "Chronic Obstructive Pulmonary Disease", + "Heavy Smoking", + "Type 2 Diabetes", + "Hypothyroidism", + "Spinal Stenosis", + "Psoriasis", + "Cyanosis", + "Tachypnea", + "Barrel Chest", + "Diffuse Rales", + "Family History of Early Onset Dementia" + ] + }, + "sigir-201424": { + "summary": "A 33-year-old male athlete presented with acute abdominal pain following a bike accident a week ago, resulting in blunt trauma to the left hemi-abdomen. He has been experiencing mild abdominal pain since the incident. The patient is in hypovolemic shock with low blood pressure and high heart rate. Imaging revealed a spleen rupture with extended intraperitoneal hemorrhage.", + "conditions": [ + "Spleen Rupture", + "Intraperitoneal Hemorrhage", + "Blunt Abdominal Trauma", + "Hypovolemic Shock", + "Acute Abdominal Pain" + ] + }, + "sigir-201425": { + "summary": "An 8-year-old boy experienced a head injury after falling from a bike, initially showing no loss of consciousness. He later developed symptoms of drowsiness, vomiting, bradycardia, hypertension, and impaired movement on the right side. The Glasgow Coma Scale was 6/15, and pupils were asymmetrical, indicating potential intracranial injury.", + "conditions": [ + "Traumatic Brain Injury", + "Epidural Hematoma", + "Intracranial Hemorrhage", + "Increased Intracranial Pressure", + "Bradycardia", + "Hypertension", + "Pupil Asymmetry", + "Hemiparesis", + "Vomiting", + "Altered Mental Status" + ] + }, + "sigir-201427": { + "summary": "The patient is a 21-year-old with a family history of multiple colonic polyps, as both siblings underwent total proctocolectomy due to hundreds of colonic adenomas. The patient has dozens of small colonic polyps in the rectosigmoid area, which are benign adenomas. The family history and current findings suggest a hereditary predisposition to colonic polyps.", + "conditions": [ + "Colonic Polyps", + "Adenomatous Polyps", + "Familial Adenomatous Polyposis", + "Hereditary Colorectal Cancer Syndrome" + ] + }, + "sigir-201429": { + "summary": "The patient is a 51-year-old woman seeking advice on osteoporosis prevention. She has a history of significant hypertension and diet-controlled Type 2 Diabetes. She is a current smoker and has recently entered menopause. Her primary concern is the risk of hip fractures as she ages.", + "conditions": [ + "Osteoporosis", + "Hypertension", + "Type 2 Diabetes", + "Smoking", + "Menopause" + ] + }, + "sigir-201430": { + "summary": "The patient is a 72-year-old man experiencing increasing calf pain when walking uphill, suggestive of peripheral artery disease. He has a history of myocardial infarction and transient ischemic attack. His blood pressure has worsened recently despite medication, and he presents with a right carotid bruit and diminished pulses in the lower extremities.", + "conditions": [ + "Peripheral Artery Disease", + "Hypertension", + "Myocardial Infarction", + "Transient Ischemic Attack", + "Carotid Artery Stenosis", + "Intermittent Claudication", + "Atherosclerosis" + ] + }, + "sigir-20151": { + "summary": "The patient is a 44-year-old male presenting with multiple episodes of vomiting with a 'coffee ground' appearance, indicating possible upper gastrointestinal bleeding. He is in a state of hypovolemic shock, evidenced by tachycardia, hypotension, decreased mental status, and cool extremities. He received fluid resuscitation and blood transfusion and was admitted to the ICU for further management.", + "conditions": [ + "Upper Gastrointestinal Bleeding", + "Hypovolemic Shock", + "Tachycardia", + "Hypotension", + "Decreased Mental Status" + ] + }, + "sigir-20152": { + "summary": "The patient is a 62-year-old male with a non-productive cough and fever, who is on immunosuppressive medications including prednisone. He was admitted to the hospital and underwent bronchoscopy with bronchoalveolar lavage. The BAL fluid examination revealed owl's eye inclusion bodies, indicating a possible viral infection.", + "conditions": [ + "Immunosuppression", + "Cytomegalovirus Infection", + "Non-productive Cough", + "Fever", + "Prednisone Use" + ] + }, + "sigir-20153": { + "summary": "A 65-year-old male with no significant cardiovascular history presents with acute shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. He recently had a right total hip replacement and experienced delayed rehabilitation due to poor pain management. Physical exam reveals a high respiratory rate and right calf pain.", + "conditions": [ + "Pulmonary Embolism", + "Postoperative Complications", + "Deep Vein Thrombosis", + "Acute Chest Pain", + "Tachypnea", + "Recent Surgery" + ] + }, + "sigir-20154": { + "summary": "An 82-year-old woman presented with chest pain and shortness of breath, with EKG showing ST-segment elevations and elevated cardiac enzymes, suggesting a myocardial event. Despite these findings, coronary angiography showed no significant stenosis, but left ventriculography and echocardiogram revealed severe segmental left ventricular dysfunction. The patient has a history of hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis, and dementia.", + "conditions": [ + "Acute Myocardial Infarction", + "Hypertension", + "Renal-Artery Stenosis", + "Chronic Renal Insufficiency", + "Hypercholesterolemia", + "Osteoporosis", + "Dementia", + "Left Ventricular Dysfunction", + "Mitral Regurgitation", + "Sinus Tachycardia", + "ST-Segment Elevation", + "Atelectasis" + ] + }, + "sigir-20155": { + "summary": "A 31-year-old woman presents with a 2-week history of joint pain and fatigue, initially experiencing right ankle swelling and difficulty walking, which resolved. She now has pain, swelling, and stiffness in her knees, hips, and right elbow, along with intermittent fevers and chest pain.", + "conditions": [ + "Polyarthritis", + "Fatigue", + "Intermittent Fever", + "Chest Pain", + "Ankle Swelling", + "Knee Pain", + "Hip Pain", + "Elbow Pain", + "Joint Stiffness" + ] + }, + "sigir-20156": { + "summary": "The patient is a 46-year-old woman experiencing significant weight loss, sweating, insomnia, and diarrhea over the past 9 months. She reports increased appetite and episodes of heart palpitations. Physical examination reveals warm, sweaty hands, an irregular pulse at 110 bpm, hyperreflexia, and mild exophthalmia.", + "conditions": [ + "Hyperthyroidism", + "Graves' Disease", + "Tachycardia", + "Insomnia", + "Diarrhea", + "Weight Loss", + "Increased Appetite", + "Palpitations", + "Hyperreflexia", + "Exophthalmos" + ] + }, + "sigir-20157": { + "summary": "The patient is a 20-year-old female college student experiencing fatigue, increased sleep and appetite, difficulty concentrating, anhedonia, and feelings of guilt. Her physical exam and laboratory tests, including hemoglobin, hematocrit, and thyroid stimulating hormone, are normal.", + "conditions": [ + "Major Depressive Disorder", + "Fatigue", + "Anhedonia", + "Increased Appetite", + "Difficulty Concentrating" + ] + }, + "sigir-20158": { + "summary": "The patient is a 10-year-old boy experiencing nighttime snoring, pauses in breathing, and restlessness with awakenings. He shows signs of excessive daytime sleepiness, lack of attention, and declining academic performance. There is no history of headaches or night terrors.", + "conditions": [ + "Obstructive Sleep Apnea", + "Excessive Daytime Sleepiness", + "Attention Deficit Disorder", + "Sleep Disturbance" + ] + }, + "sigir-20159": { + "summary": "The patient is a 10-year-old child presenting with myalgia, cough, and shortness of breath, following a recent viral illness with low-grade fever, abdominal pain, and diarrhea. The child has a history of exposure to a farm with domestic pigs. Current symptoms include cyanosis, neck stiffness, and periorbital edema. Lab results show leukocytosis with significant eosinophilia.", + "conditions": [ + "Myalgia", + "Cough", + "Shortness of Breath", + "Viral Illness", + "Fever", + "Abdominal Pain", + "Diarrhea", + "Cyanosis", + "Neck Stiffness", + "Periorbital Edema", + "Leukocytosis", + "Eosinophilia", + "Possible Trichinellosis", + "Possible Swine Influenza" + ] + }, + "sigir-201510": { + "summary": "The patient is a 38-year-old woman experiencing severe premenstrual and menstrual pelvic pain, heavy and irregular periods, and occasional spotting between periods. She has a history of infertility treatment over two years and an ectopic pregnancy at age 26.", + "conditions": [ + "Dysmenorrhea", + "Menorrhagia", + "Irregular Menstrual Cycles", + "Intermenstrual Bleeding", + "Infertility", + "Ectopic Pregnancy" + ] + }, + "sigir-201511": { + "summary": "The patient is a 56-year-old Caucasian female experiencing increased sensitivity to cold, fatigue, decreased appetite, constipation, hyporeflexia, dry skin, and slow movement and speech. These symptoms suggest a possible underlying endocrine disorder.", + "conditions": [ + "Hypothyroidism", + "Cold Intolerance", + "Fatigue", + "Constipation", + "Hyporeflexia", + "Dry Skin", + "Bradykinesia", + "Decreased Appetite" + ] + }, + "sigir-201512": { + "summary": "The patient is a 44-year-old man who sustained a skull fracture in an automobile accident. He presented with clear fluid dripping from his nose, severe headache, fever, and nuchal rigidity. These symptoms suggest a possible cerebrospinal fluid leak and meningitis.", + "conditions": [ + "Skull Fracture", + "Cerebrospinal Fluid Leak", + "Meningitis", + "Headache", + "Fever", + "Nuchal Rigidity" + ] + }, + "sigir-201513": { + "summary": "A 5-year-old boy presents with progressively worsening dysphagia, drooling, fever, and vocal changes. He appears toxic and leans forward while sitting, with a muffled 'hot potato' voice. The parents report delaying some of his vaccines and deny foreign body ingestion or trauma.", + "conditions": [ + "Dysphagia", + "Drooling", + "Fever", + "Vocal Cord Dysfunction", + "Toxic Appearance", + "Delayed Vaccination", + "Epiglottitis" + ] + }, + "sigir-201514": { + "summary": "A 27-year-old pregnant woman at 11 weeks gestation presents with anemia, thrombocytopenia, and macrocytosis. Despite iron supplementation, her hemoglobin levels remain low, and she has difficulty swallowing. Laboratory findings suggest hemolytic anemia with elevated LDH, anisocytosis, poikilocytosis, and hemosiderinuria.", + "conditions": [ + "Anemia", + "Thrombocytopenia", + "Macrocytosis", + "Hemolytic Anemia", + "Iron Deficiency", + "Dysphagia", + "Elevated Lactate Dehydrogenase", + "Anisocytosis", + "Poikilocytosis", + "Polychromasia", + "Hemosiderinuria", + "Pregnancy" + ] + }, + "sigir-201515": { + "summary": "Karen is a 72-year-old woman with a history of hypertension and type 2 diabetes who recently experienced a cryptogenic stroke. She was treated with thrombolytic therapy and her symptoms resolved. Current evaluations show normal blood pressure, glucose levels, and sinus rhythm, but she reports occasional palpitations, shortness of breath, and chest pain.", + "conditions": [ + "Cryptogenic Stroke", + "Hypertension", + "Type 2 Diabetes", + "Palpitations", + "Shortness of Breath", + "Chest Pain", + "Normal Sinus Rhythm" + ] + }, + "sigir-201516": { + "summary": "A 4-year-old boy presents with wheezing after playing in a sandbox. He has a history of allergic rhinitis but no prior wheezing episodes. The wheezing started suddenly after a brief coughing episode. He is otherwise well-appearing with normal oxygen saturation levels.", + "conditions": [ + "Wheezing", + "Allergic Rhinitis", + "Acute Respiratory Distress", + "Possible Foreign Body Aspiration" + ] + }, + "sigir-201517": { + "summary": "A 32-year-old female with no previous medical history is in good health but has tested HPV positive on her recent pap smear, despite having cytology negative results. She has no current complaints.", + "conditions": [ + "HPV Positive" + ] + }, + "sigir-201518": { + "summary": "The patient is a 65-year-old African-American male experiencing worsening shortness of breath on exertion over the past three weeks. He has orthopnea, requiring two to three extra pillows at night. Physical examination reveals bibasilar lung crackles, pitting ankle edema, and jugular venous distension.", + "conditions": [ + "Heart Failure", + "Orthopnea", + "Dyspnea on Exertion", + "Pulmonary Edema", + "Jugular Venous Distension", + "Pitting Edema" + ] + }, + "sigir-201519": { + "summary": "The patient is a 66-year-old female with a significant smoking history and chronic cough, experiencing progressive shortness of breath and moderate respiratory distress. Physical examination shows distended neck veins, a barrel-shaped chest, and wheezing. She has a long history of heavy smoking, which suggests possible chronic obstructive pulmonary disease (COPD).", + "conditions": [ + "Chronic Obstructive Pulmonary Disease", + "Chronic Cough", + "Dyspnea", + "Tobacco Use Disorder", + "Respiratory Distress", + "Wheezing", + "Barrel Chest" + ] + }, + "sigir-201520": { + "summary": "The patient is an 89-year-old man experiencing progressive cognitive and personality changes over six months, including memory loss, language difficulties, and unusual behaviors. He exhibits paratonic rigidity, myoclonic jerks, and brisk reflexes, with significant impairment in daily activities. The patient shows signs of disorientation, apraxia, and possible aphasia.", + "conditions": [ + "Dementia", + "Cognitive Impairment", + "Aphasia", + "Apraxia", + "Myoclonus", + "Paratonia", + "Bradycardia", + "Irregular Heart Rhythm", + "Disorientation", + "Personality Changes", + "Memory Loss", + "Language Disorder", + "Behavioral Symptoms" + ] + }, + "sigir-201521": { + "summary": "The patient is a 32-year-old male experiencing diarrhea, abdominal cramping, flatulence, greasy and foul-smelling stools, loss of appetite, and malaise. These symptoms began after a hiking trip where he consumed untreated water. A stool smear test revealed the presence of ellipsoidal cysts with smooth walls and 2+ nuclei, suggesting a parasitic infection.", + "conditions": [ + "Giardiasis", + "Diarrhea", + "Abdominal Cramping", + "Flatulence", + "Steatorrhea", + "Loss of Appetite", + "Malaise", + "Parasitic Infection" + ] + }, + "sigir-201522": { + "summary": "The patient is a 65-year-old male with a history of tuberculosis, presenting with a productive cough containing blood. Imaging shows a round opaque mass in a cavity in the left upper lobe, which moves with position changes. Sputum culture indicates the presence of a fungal organism with septated, low-angle branching hyphae.", + "conditions": [ + "Pulmonary Aspergilloma", + "Tuberculosis", + "Hemoptysis", + "Lung Cavity" + ] + }, + "sigir-201523": { + "summary": "An 18-year-old male presents with high fever, chills, facial flushing, epistaxis, severe headache, and joint pain after returning from Asia. Laboratory findings show leukopenia, increased hematocrit, and thrombocytopenia.", + "conditions": [ + "Dengue Fever", + "Viral Hemorrhagic Fever", + "Leukopenia", + "Thrombocytopenia", + "Increased Hematocrit", + "Epistaxis", + "Fever", + "Headache", + "Arthralgia" + ] + }, + "sigir-201524": { + "summary": "A 31-year-old male with no significant past medical history presents with a productive cough, chest pain, fever, and chills. Symptoms began with a cold one week ago, improved, then worsened with new fever and right-sided chest pain aggravated by coughing. Lung exam shows expiratory wheezing, decreased breath sounds, and egophony in the left lower lung field.", + "conditions": [ + "Pneumonia", + "Acute Respiratory Infection", + "Fever", + "Cough", + "Chest Pain", + "Wheezing" + ] + } +} \ No newline at end of file diff --git a/results/retrieved_trials.json b/results/retrieved_trials.json new file mode 100644 index 0000000..43bab08 --- /dev/null +++ b/results/retrieved_trials.json @@ -0,0 +1,2699 @@ +[ + { + "patient_id": "sigir-20141", + "patient": "<0.> A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. <1.> The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. <2.> The latest episode of pain ended half an hour prior to her arrival. <3.> She is known to have hypertension and obesity. <4.> She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. <5.> She currently takes no medications. <6.> Physical examination is normal. <7.> The EKG shows nonspecific changes. <8.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT01397994", + "brief_title": "Study to Assess Efficacy of Nicorandil+Atenolol vs Atenolol in Treatment of Chronic Stable Angina.", + "phase": "Phase 4", + "drugs": "['Nicorandil', 'Atenolol']", + "drugs_list": [ + "Nicorandil", + "Atenolol" + ], + "diseases": "['Chronic Stable Angina']", + "diseases_list": [ + "Chronic Stable Angina" + ], + "enrollment": "40.0", + "inclusion_criteria": "inclusion criteria: \n\n Patients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes. \n\n Male and female \n\n Age 25 to 65 years \n\n Patient must understand and be willing, able and likely to comply with all study procedures and restrictions and comprehends the diary cards. \n\n Patient must be able to give voluntary written informed consent. \n\n ", + "exclusion_criteria": ": \n\n Hypertension of > 170/100 mm of Hg \n\n Valvular heart disease and cardiomyopathy \n\n Myocardial infarction in < 6 months \n\n Unstable angina \n\n Congestive cardiac failure \n\n Severe anemia (Hb 7G/dl) \n\n Cardiac arrhythmias or II or III degree AV block \n\n Significant liver or renal dysfunction \n\n IDDM (Type-1 diabetes mellitus) \n\n Systolic blood pressure < 100 mm Hg \n\n Pregnant and nursing women \n\n Known hypersensitivity to nicorandil \n\n On calcium channel blockers \n\n Patients not eligible for Tc 99m SPECT \n\n Patients in whom beta blockers are contraindicated \n\n Geographical inaccessibility for treatment or follow-up evaluations", + "brief_summary": "This study is to determine the anti-anginal and anti-ischemic effect of k-channel opener, nicorandil in patients of chronic stable angina.", + "NCTID": "NCT01397994", + "total_score": 0.15117683686995748, + "bm25_score": 0.06112374557238058, + "medcpt_score": 0.0900530912975769 + }, + { + "nct_id": "NCT00149227", + "brief_title": "Add-on Effects of Valsartan on Morbi- Mortality (KYOTO HEART Study)", + "phase": "Phase 4", + "drugs": "['Valsartan', 'Non-ARB']", + "drugs_list": [ + "Valsartan", + "Non-ARB" + ], + "diseases": "['Hypertension', 'Ischemic Heart Disease', 'Congestive Heart Failure', 'Stroke']", + "diseases_list": [ + "Hypertension", + "Ischemic Heart Disease", + "Congestive Heart Failure", + "Stroke" + ], + "enrollment": "3031.0", + "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of hypertension \n\n Clinical diagnosis of one or more risk factors, such as diabetes, smoking habit, lipid metabolism abnormality, history of ischemic heart disease (IHD) or cerebrovascular disease, obesity (BMI>25), chronic heart failure (NYHA II-III), and electrocardiogram (ECG) abnormality (LVH) \n\n ", + "exclusion_criteria": ": \n\n Patients who have already been administered ARB \n\n Patients with IHD within 6 months after percutaneous coronary intervention(PCI), and who are stable but are going to implement PCI or coronary artery bypass grafting(CABG) \n\n Severe/malignant/secondary hypertensive patients \n\n Pregnant women and women of childbearing potential \n\n History of heart failure, unstable angina, myocardial infarction, PTCA, or CABG within the preceding 6 months \n\n Arrhythmia needed to be treated or accompanied with symptoms, second or third degree AV block \n\n Severe renal impairment (Serum creatinine >3.0 mg/dl) \n\n Severe hepatic impairment (Hepatic failure, Cirrhosis, etc.)", + "brief_summary": "The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients in Japan with hypertension in terms of the morbidity and mortality.", + "NCTID": "NCT00149227", + "total_score": 0.14600868204993006, + "bm25_score": 0.0748999888999889, + "medcpt_score": 0.07110869314994117 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-20142", + "patient": "<0.> An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. <1.> He has just returned from a 5 day vacation in Colorado. <2.> Parents report that prior to the onset of fever and cough, he had loose stools. <3.> He denies upper respiratory tract symptoms. <4.> On examination he is in respiratory distress and has bronchial respiratory sounds on the left. <5.> A chest x-ray shows bilateral lung infiltrates. <6.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT00711399", + "brief_title": "Assessment of Cough and Wheeze With Breath Sound Documenting Device", + "phase": "", + "drugs": "['PulmoTrack\u00ae 2010 with WIM-PC\u2122 and WIM-CC\u2122 Technologies']", + "drugs_list": [ + "PulmoTrack\u00ae 2010 with WIM-PC\u2122 and WIM-CC\u2122 Technologies" + ], + "diseases": "['Respiratory Sounds']", + "diseases_list": [ + "Respiratory Sounds" + ], + "enrollment": "55.0", + "inclusion_criteria": "inclusion criteria: \n\n Patient and/or parents/guardian signed informed consent \n\n Patients with cough or shortness of breath \n\n ", + "exclusion_criteria": ": \n\n Chest tubes \n\n Skin lesions precluding attachment of sensors \n\n Respiratory distress \n\n Pregnant women", + "brief_summary": "The study goal is to create a database of respiratory sounds recordings, to evaluate and validate the WIM technology and to evaluate the efficacy of a specific treatment by comparing the severity of the respiratory symptoms before and after the administration of the treatment.", + "NCTID": "NCT00711399", + "total_score": 0.1727606964264646, + "bm25_score": 0.07168411427845392, + "medcpt_score": 0.10107658214801071 + }, + { + "nct_id": "NCT02618655", + "brief_title": "Clinical Research for the Diagnosis of Tick-borne Diseases in Patients With Unexplained Acute Fever", + "phase": "", + "drugs": "['diagnostic methods']", + "drugs_list": [ + "diagnostic methods" + ], + "diseases": "['Fever of Unknown Origin', 'Tick-borne Diseases']", + "diseases_list": [ + "Fever of Unknown Origin", + "Tick-borne Diseases" + ], + "enrollment": "200.0", + "inclusion_criteria": "inclusion criteria: \n\n patients have fever more than one week \n\n temperature is higher than 38\u2103 Celsius degree \n\n full of physical examination and laboratory examination have been carried out after one week\uff0cbut still cannot make a definite diagnosis \n\n ", + "exclusion_criteria": ": \n\n fever for non-infectious diseases such as rheumatic autoimmune disease or with tumor \n\n we find that the patient selected does not meet the selection criteria within the observation period \n\n patients leave with automatic discharge", + "brief_summary": "The study will use several laboratory diagnoses in the diagnosis of patients with fever\uff0cto find out which will be more helpful for making an accurate diagnosis in the early period of Tickborne Diseases.", + "NCTID": "NCT02618655", + "total_score": 0.1415819174264138, + "bm25_score": 0.06793223961006935, + "medcpt_score": 0.07364967781634449 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-20143", + "patient": "<0.> A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. <1.> She is otherwise asymptomatic. <2.> A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe. <3.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT02490059", + "brief_title": "Ultrathin Bronchoscopy for Solitary Pulmonary Nodules", + "phase": "Phase 4", + "drugs": "['bronchoscopy']", + "drugs_list": [ + "bronchoscopy" + ], + "diseases": "['Lung Cancer']", + "diseases_list": [ + "Lung Cancer" + ], + "enrollment": "40.0", + "inclusion_criteria": "inclusion criteria: \n\n Pulmonary nodule on a recent CT \n\n non-visible on standard-size bronchoscopy \n\n ", + "exclusion_criteria": ": \n\n missing informed consent", + "brief_summary": "The evaluation of solitary pulmonary nodules (SPN) requires a balance between procedure-related morbidity and diagnostic yield, particularly in areas where tuberculosis is endemic. Data on ultrathin bronchoscopy (UB) for this purpose is limited. In this prospective randomised trial we compared diagnostic yield and adverse events of UB with standard-size bronchoscopy (SB) in a cohort of patients with SPN located beyond the visible range of SB.", + "NCTID": "NCT02490059", + "total_score": 0.14319217819217822, + "bm25_score": 0.07632154882154883, + "medcpt_score": 0.06687062937062938 + }, + { + "nct_id": "NCT01452971", + "brief_title": "A Study of the Interaction Between Tumor Susceptibility Gene Glycine N-methyltransferase (GNMT) and Lung Cancer", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Lung Cancer']", + "diseases_list": [ + "Lung Cancer" + ], + "enrollment": "200.0", + "inclusion_criteria": "inclusion criteria: \n\n Participant is a lung cancer patient. \n\n ", + "exclusion_criteria": ": \n\n Participant is under 18 years old. \n\n Participant is not a lung cancer patient.", + "brief_summary": "Environmental carcinogens such as polycyclic aromatic hydrocarbons (PAHs) were reviewed as the major risk factors for lung cancer development. In this proposal, the investigators collected fifteen kinds of major PAHs and the investigators would like to perform the following studies:~Study the gene expression and subcellular localization of GNMT in the normal-tumor tissue pairs of lung cancer patients.~Study the associations of the polymorphisms of GNMT in lung cancer patients and the susceptibility to lung cancer;~To assess the allelic loss at GNMT and determined the LOH rate of GNMT in the normal-tumor tissue pairs of lung cancer patients.~Study the associations of the copy number variation (CNV) of GNMT and the susceptibility to lung cancer;~Study the interaction between GNMT and polycyclic aromatic hydrocarbons (PAHs) in lung cancer cell lines.", + "NCTID": "NCT01452971", + "total_score": 0.10671430092981266, + "bm25_score": 0.0624350845410628, + "medcpt_score": 0.04427921638874986 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-20144", + "patient": "<0.> A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. <1.> The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. <2.> The abdominal exam demonstrates tenderness and enlarged liver. <3.> Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. <4.> The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. <5.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT02390596", + "brief_title": "Anakinra and Kawasaki Disease", + "phase": "Phase 2", + "drugs": "['Anakinra']", + "drugs_list": [ + "Anakinra" + ], + "diseases": "['Kawasaki Disease', 'Children']", + "diseases_list": [ + "Kawasaki Disease", + "Children" + ], + "enrollment": "16.0", + "inclusion_criteria": "inclusion criteria: \n\n Patients, male and female, at any age \u2265 3 months (5 kg) of life, with KD according to the American Heart Association definition for complete or incomplete KD. fever \u2265 5 days and \u2265 4 of 5 main clinical signs: modification of the extremities, polymorphic exanthema, bilateral bulbar not exudative conjunctivitis, erythema of the lips or oral cavity, and cervical lymph nodes usually unilateral > 1.5 cm in diameter. In the presence of less than 4 clinical criteria and 5 days of fever, the diagnosis of disease KD is proposed in case of coronary abnormalities (at least one dilated coronary artery with internal diameter \u2265 2,5 SD from the mean normalized for body surface area (Z score) as determined by echocardiography. For indicative purpose, in case of incomplete KD, other biological supportive criteria for incomplete KD can help to ensure the diagnosis: leucocytosis, elevated CRP, elevated ESR, anaemia, hyponatremia, elevated ASAT, ALAT and gGT, hyperlipidaemia. \n\n Patients who failed to respond to standard therapy of KD:, e.g. Persistence or recrudescence of fever \u2265 38\u00b0C, 48 hours after the infusion of 2g/kg of IV Ig, \n\n Weight \u22655Kg \n\n Patient, parent or legal guardian's written informed consent is required \n\n Patient with health insurance \n\n Patient agrees to have effective contraception for the duration of participation in the research \n\n ", + "exclusion_criteria": ": \n\n Preterm and neonates, pregnancy \n\n Patients suspected with another diagnosis \n\n Patients with overt concomitant bacterial infection \n\n Patients previously treated with another biotherapy \n\n Patients with any type of immunodeficiency or cancer \n\n Patients with increased risk of TB infection \n\n Recent tuberculosis infection or with active TB \n\n Close contact with a patient with TB \n\n Patients recently arrived less than 3 months from a country with high prevalence of TB \n\n A chest radiograph suggestive of TB \n\n Patients with end stage renal disease: NKF stages \u22654; eGFR\u226429mL/min/1.73 m2 or diabetes mellitus or neutropenia <1500/mm3 or liver failure \n\n Hypersensitivity to the active substance or to any of the excipients (citric acid and anhydrous; sodium chloride disodium edetate dehydrate polysorbate 80; sodium hydroxide; water for injections) \n\n Patient already included in a biomedical research other than observational (e.g.; cohort, registry)", + "brief_summary": "The study is designed to assess the efficacy and safety of anakinra, an interleukin 1 receptor antagonist, in patients with Kawasaki disease who failed to respond to standard treatment:e.g. one infusion of 2g/kg of intravenous immunoglobulins.", + "NCTID": "NCT02390596", + "total_score": 0.2764160011906148, + "bm25_score": 0.1219122046549403, + "medcpt_score": 0.15450379653567448 + }, + { + "nct_id": "NCT00841789", + "brief_title": "Etanercept in Kawasaki Disease", + "phase": "Phase 2", + "drugs": "['Etanercept', 'Placebo']", + "drugs_list": [ + "Etanercept", + "Placebo" + ], + "diseases": "['Mucocutaneous Lymph Node Syndrome', 'Kawasaki Disease']", + "diseases_list": [ + "Mucocutaneous Lymph Node Syndrome", + "Kawasaki Disease" + ], + "enrollment": "196.0", + "inclusion_criteria": "inclusion criteria: \n\n Male Age 2 months to 20 years of age Female Age 2 months to 11 years of age \n\n Provision of Parental Consent \n\n Kawasaki Disease Presentation \n\n ", + "exclusion_criteria": ": \n\n Laboratory Criteria: Any laboratory toxicity, at the time of the screening visit or at any time during the study that in the opinion of the Investigator would preclude participation in the study or: \n\n Platelet count < 100,000/mm3 \n\n WBC count < 3,000 cells/mm3 \n\n Hemoglobin, hematocrit, or red blood cell count outside 30% of the upper or lower limits of normal for the Lab \n\n Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit. \n\n Female subjects diagnosed with KD 12 years of age and older. \n\n Subjects who have known hypersensitivity to Enbrel or any of its components or who is known to have antibodies to etanercept \n\n Prior or concurrent cyclophosphamide therapy \n\n Prior treatment with any TNF alpha antagonist or steroid within 48 hours prior to initiation of IVIG \n\n Concurrent sulfasalazine therapy \n\n Active severe infections within 4 weeks before screening visit, or between the screening and baseline visits. \n\n SLE, history of multiple sclerosis, transverse myelitis, optic neuritis, or chronic seizure disorder \n\n Known HIV-positive status or known history of any other immuno-suppressing disease. \n\n Any mycobacterial disease or high risk factors for tuberculosis, such as family member with TB or taking INH \n\n Untreated Lyme disease \n\n Severe comorbidities (diabetes mellitus requiring insulin, CHF of any severity, MI, CVA or TIA within 3 months of screening visit, unstable angina pectoris, uncontrolled hypertension (sitting systolic BP > 160 or diastolic BP > 100 mm Hg), oxygen-dependent severe pulmonary disease, history of cancer within 5 years [other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer]) \n\n Exposure to hepatitis B or hepatitis C or high risk factors such as intravenous drug abuse in patient's mother, or history of jaundice (other than neonatal jaundice). SLE, history of multiple sclerosis, transverse myelitis, optic neuritis or chronic seizure disorder. \n\n Use of a live vaccine (Measles Mumps Rubella or Varicella) 30 days prior to or during this study. \n\n Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient \n\n History of non-compliance with other therapies \n\n Must not have received immunosuppressive agents for at least three months prior to enrollment.", + "brief_summary": "The purpose of this study is to determine whether Etanercept (Enbrel) when used in conjunction with IVIG and aspirin, improves treatment response to IVIG in patients with Kawasaki Disease. Funding Source- FDA/OOPD", + "NCTID": "NCT00841789", + "total_score": 0.21840722774057333, + "bm25_score": 0.08568449538574596, + "medcpt_score": 0.13272273235482737 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-20145", + "patient": "<0.> A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. <1.> The patient says that she has remained in bed for the last two weeks. <2.> The physical examination reveals tenderness on the left upper thoracic wall and right calf. <3.> The surgical incision shows no bleeding or signs of infection. <4.> Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. <5.> Laboratory tests reveal an elevated D-dimer. <6.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT00163709", + "brief_title": "BNP Testing in Patients With SOB on Presentation to ED", + "phase": "Phase 1", + "drugs": "['BNP test']", + "drugs_list": [ + "BNP test" + ], + "diseases": "['Heart Failure, Congestive']", + "diseases_list": [ + "Heart Failure", + "Congestive" + ], + "enrollment": "600.0", + "inclusion_criteria": "inclusion criteria: \n\n We plan to include all patients presenting to the ED with shortness of breath that are over 40 years old and present with an emergency department triage category of 3 or higher. \n\n ", + "exclusion_criteria": ": \n\n Patients presenting with a traumatic cause of dyspnea, patients with severe renal disease (serum creatinine level of more than 250 micro mmol/L, patients with cardiogenic shock, and patients who have an early transfer to another hospital (within 24 hrs) will be excluded.", + "brief_summary": "A trial to examine whether a new heart failure blood test can improve the outcome of patients presenting to the Emergency Department with shortness of breath.~We hypothesise that a BNP test performed in real-time in patients presenting to the Emergency Department with shortness of breath will help identify additional patients with CHF and consequently to change practice and allow more patients to recieve correct treatment earlier.", + "NCTID": "NCT00163709", + "total_score": 0.1293754878309331, + "bm25_score": 0.058863827925000785, + "medcpt_score": 0.07051165990593229 + }, + { + "nct_id": "NCT01935141", + "brief_title": "Efficacy of Low (30ml) Versus Full Dose (100ml) Contrast CT Pulmonary Angiography in Detecting Emboli", + "phase": "", + "drugs": "['Low-Dose IV Contrast', 'Siemens Sensation 64-MDCT scanner.', 'Visipaque 320 non-ionic isoosmolar contrast agent']", + "drugs_list": [ + "Low-Dose IV Contrast", + "Siemens Sensation 64-MDCT scanner.", + "Visipaque 320 non-ionic isoosmolar contrast agent" + ], + "diseases": "['Multiple Pulmonary Emboli']", + "diseases_list": [ + "Multiple Pulmonary Emboli" + ], + "enrollment": "0.0", + "inclusion_criteria": "inclusion criteria: \n\n Patients referred for CT pulmonary angiogram to exclude pulmonary embolus \n\n ", + "exclusion_criteria": ": \n\n Class 3 or 4 Congestive Heart Failure \n\n Supraventricular tachycardia \n\n History of contrast allergy \n\n Unable to give informed consent \n\n Patients with serum creatinine >1.28 mg/dl without referring physician approval", + "brief_summary": "With the improvement in CT scanners and injectors, diagnostic chest CT can now be performed in less than 10 seconds. It was hypothesized that diagnostic CT pulmonary angiograms could be done with less than the usual 80-120 ml of contrast used. We have developed a method of performing diagnostic CT pulmonary angiograms with 30 ml of intravenous contrast in most patients. The long-term objective of this study is to show that there is no difference in the diagnostic efficacy of this low dose 30 ml technique when compared to the more traditional full-dose technique.", + "NCTID": "NCT01935141", + "total_score": 0.1067859410942698, + "bm25_score": 0.0545015856903584, + "medcpt_score": 0.05228435540391141 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-20146", + "patient": "<0.> 64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. <1.> She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. <2.> She complains of a painful skin lesion on the left lower leg. <3.> She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. <4.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT00015626", + "brief_title": "A Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)", + "phase": "Phase 2", + "drugs": "['Metformin', 'skin biopsy', 'diet and exercise', 'pioglitazone', 'rosiglitazone']", + "drugs_list": [ + "Metformin", + "skin biopsy", + "diet and exercise", + "pioglitazone", + "rosiglitazone" + ], + "diseases": "['Insulin Resistance', 'Diabetes Mellitus']", + "diseases_list": [ + "Insulin Resistance", + "Diabetes Mellitus" + ], + "enrollment": "300.0", + "inclusion_criteria": "inclusion criteria: \n\n Obese patients (wt > 95th percentile for age, for adults increased BMI > 27) greater than 5 years of age \n\n And/or presence of complications of insulin resistance such as acanthosis nigricans, dyslipidemia, elevated blood pressure, hyperandrogenism \n\n Siblings and parents of patients with insulin resistance. Siblings and parents will be included only in the case of documented insulin resistance in the index subject. Insulin resistance will be documented by OGTT and/or IVGTT. \n\n Family history of type II diabetes. \n\n ", + "exclusion_criteria": ": \n\n Critically ill patients, patients will congestive heart failure, renal or liver insufficiency \n\n Inability to give consent. \n\n History of poor compliance with physician's recommendations", + "brief_summary": "The goal of this study is to aggressively treat insulin resistance and its clinical manifestations when they first appear in childhood, and to prevent the subsequent progression towards impaired glucose tolerance and type-2 diabetes. In the process of this clinical trial, we will learn more about the early manifestations of insulin resistance, its treatment, and its relationship to obesity and type-2 diabetes through parallel in-vivo and in-vitro studies.", + "NCTID": "NCT00015626", + "total_score": 0.1926724353273589, + "bm25_score": 0.08671237388342652, + "medcpt_score": 0.10596006144393241 + }, + { + "nct_id": "NCT02512159", + "brief_title": "Skin Ulcers Treatment With an Handicraft Topical Device", + "phase": "Phase 4", + "drugs": "['drenovac handcrafted', 'Healing']", + "drugs_list": [ + "drenovac handcrafted", + "Healing" + ], + "diseases": "['Foot Ulcer', 'Varicose Ulcer']", + "diseases_list": [ + "Foot Ulcer", + "Varicose Ulcer" + ], + "enrollment": "144.0", + "inclusion_criteria": "inclusion criteria: \n\n Patients with cutaneous leg ulcers due to diabetes mellitus, venous stasis and arterial insufficiency requiring healing or tissue debrided sent to managing their disease to regional general hospital No. 17, Instituto Mexicano del Seguro Social, Benito Ju\u00e1rez, Quintana Roo. \n\n Patients of both sexes. \n\n Patients over 18 years. \n\n Patients that have basic laboratory at admission (complete blood count with differential). \n\n Patients with comorbidities associated as Diabetes Mellitus , Hypertension, stroke, heart disease, nephropathy, venous insufficiency and arterial insufficiency, etc. \n\n ", + "exclusion_criteria": ": \n\n Hemodynamically unstable patients. \n\n Patients with septic shock from any source. \n\n Patients with deep skin ulcers with exposed some organ, data osteomyelitis, vascular-nervous exposure. \n\n Patients with secondary cutaneous ulcer enteral fistula. \n\n Patients with cutaneous ulcer or cancer tumors. \n\n Patients with cutaneous ulcer with active bleeding. \n\n Patients with cutaneous ulcer necrosis. \n\n Patients with cutaneous ulcer leishmania, insect bite. \n\n Patients with cutaneous ulcer burns. \n\n Patients who do not accept their participation in the study through informed consent.", + "brief_summary": "The aim of this study was to evaluate the efficacy of a handicraft topical device of negative pressure versus traditional healing treatment for skin ulcers in lower limbs; in patients with diabetes mellitus, venous stasis and arterial insufficiency.", + "NCTID": "NCT02512159", + "total_score": 0.15588473132541703, + "bm25_score": 0.08469548456786122, + "medcpt_score": 0.07118924675755584 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-20147", + "patient": "<0.> A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. <1.> She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. <2.> She also states that she has had thoughts of suicide. <3.> She often finds herself fidgety and unable to sit still for extended periods of time. <4.> Her family tells her that she is increasingly irritable. <5.> Her current medications include lithium carbonate and zolpidem. <6.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT01863628", + "brief_title": "Recognition and Early Intervention on Prodrome in Bipolar Disorders", + "phase": "", + "drugs": "['aerobic exercise', 'psychoeducation']", + "drugs_list": [ + "aerobic exercise", + "psychoeducation" + ], + "diseases": "['Bipolar Disorder']", + "diseases_list": [ + "Bipolar Disorder" + ], + "enrollment": "120.0", + "inclusion_criteria": "inclusion criteria: \n\n have at least one biological parent diagnosed as bipolar disorder (bipolar I or II) \n\n have at least one of the following syndromes i) two or more DSM-IV defined hypomania/mania symptoms, lasting for at least 4 days; ii) two or more DSM defined major depressive symptoms, lasting for 1 week; iii) at least one of the psychotic symptoms, lasting at least 10 min for each manifestation, and 2-7 manifestations a week for at least 3 months, including: ideas of reference; odd ideas, odd belief, unusual perceptual experiences, bizarre thought or speech, Grandiosity, suspicious ideas, paranoid idea, odd mannerisms, hallucination, disorganized/catatonic behavior; iv)two or more of the DSM-IV defined Attention deficit hyperactivity disorder (ADHD)symptoms; and there must be clear evidence of clinically significant impairment in social, academic, or occupational functioning due to ADHD symptoms \n\n ", + "exclusion_criteria": ": \n\n DSM-IV defined Axis I disorders; \n\n Serious general medical illness; \n\n mental retardation; \n\n was/is treated with antipsychotic drugs; \n\n unable to complete neuropsychological tests due to physical conditions; \n\n in pregnancy and lactation; \n\n was taking thyroxine therapy in the last three months or is taking hormone therapy", + "brief_summary": "Background and study hypothesis:~Many studies including prospective studies have been demonstrated that a long symptomatic prodromal phase exists prior to the onset of full-brown bipolar disorder, lasting for 9-12 years (Egeland et al., 2000). During the prodromal stage, there are three main clusters of syndromes, including hypomania/mania symptoms, depressive symptoms, and signs of attention deficit hyperactivity disorders (Correll et al., 2007; Tillman et al., 2003; Mantere et al., 2008). Of the hypomania/mania symptoms, decreased sleep, elevated mood, irritability, mood lability, increased energy, and psychomotor agitation are present most frequently. The prodromal depressive symptoms are reported to be depressed mood, anhedonia, insomnia, feelings of worthlessness. Among patients with bipolar disorders, 22.5% reported to comorbid with pediatric ADHD. In addition, some symptoms are considered as non-specific such as decreased functioning, anger outburst, social isolation, and anxiety (Egeland et al., 2000).~Offspring of parents with bipolar disorders are much likely to present prodromal symptoms compared to offspring of healthy parents. In a 10-year longitudinal study using 55 prodromal symptoms checklist, , Egeland et al.(2002) found that 38% offspring of parents with bipolar disorder were considered as at risk compared to 17% in children of healthy parents. In a 15-year follow-up study, Duffy et al.,(2009) found that 32.7% offspring (aged 8-25 years old) of parents with bipolar disorder met the criteria of major mood episode.~Objectives:~One primary objective of this study is to prospectively identify the prodromal stage of bipolar disorder.~Another primary objective is to conduct a randomized, place-controlled trial of aerobic exercise on people who suffering from prodromal symptoms to the extent of significantly impaired function, with attempt at delaying or preventing the onset of a full-blown bipolar disorder.~Design of study and the procedures:~The study will consist of two phases: one-week screening period and a randomized, placebo-controlled, 3-month trial. During the screening period, offspring of parents with bipolar disorder will undergo systematically clinical evaluations. The offspring will be evaluated with clinical symptoms assessing scales, neuropsychological tests, magnetic resonance imaging. During the 3-month trial period, the offspring who meet the inclusion criteria will be randomly assigned to receive treatment of aerobic exercise, placebo, or wait-list group. Psychiatrists are scheduled to assess mood, treatment outcome during the 3-month trial.~Subjects and treatment It is expected that 120 offspring of parents with bipolar disorder aged between 10-25 years, meeting the inclusion of prodromal stage, will be included in the study. All of the offspring will undertake the Kiddie Sads Present and Lifetime Version (K-SADS-PL), and a 70 checklist items of potential prodromal symptoms suggest by us as well as by Dr. Correll et al. (2007). The parents of these offspring are to have a DSM-IV (Diagnostic and Statistical Manual of Mental Disorders)-defined bipolar disorder (bipolar I or II), confirmed by the Chinese version of Structured Clinical interview for DSM-IV-TR Axis I Disorders patient edition (SCID-I/P) [First et al., 2002]. The offspring are to be recruited through the referrals by their parents who will receive psychiatric services in the Guangzhou psychiatric Hospital.~The offspring will be randomly assigned to aerobic exercise and placebo controlled groups. The aerobic exercise would include cycling, jogging,table tennis, and playing badminton for 40 mins at least 3 times a week for 3 months. In each exercise, participants are supposed to exercise to the extent of getting sweaty. In the placebo group, participants will receive general psychoeducation, including delivering knowledge on symptoms, discussion of the suffering mental difficulties, and general coping techniques.~Significance:~Bipolar disorder is a common, chronic, and recurrent mental disorder. The recognition of prodromal stage of bipolar disorder and the early intervention on it may help delay or prevent the onset of bipolar disorder.", + "NCTID": "NCT01863628", + "total_score": 0.21028265088235104, + "bm25_score": 0.09290099268547546, + "medcpt_score": 0.11738165819687561 + }, + { + "nct_id": "NCT00845988", + "brief_title": "Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders", + "phase": "Phase 4", + "drugs": "['aripiprazole']", + "drugs_list": [ + "aripiprazole" + ], + "diseases": "['Bipolar Disorders', 'Metabolic Complication']", + "diseases_list": [ + "Bipolar Disorders", + "Metabolic Complication" + ], + "enrollment": "28.0", + "inclusion_criteria": "inclusion criteria: \n\n patients with bipolar disorders (I, II, NOS) diagnosed with DSM-IV criteria \n\n age between 18 and 65 \n\n Decisional capacity is adequate to provide informed consent or has an authorized appropriate surrogate decision maker. in a syndromal remission state at least for 2 months : CGI - BP \u2264 3 \n\n patients who have exhibited a clinically significant increase in body weight after starting the administration of their current antipsychotic (ie >7% weight gain) \n\n ", + "exclusion_criteria": ": \n\n diagnosis of eating disorder, substance abuse, and psychotic disorder \n\n history of neurological and medical illness \n\n pregnant or breast feeding women", + "brief_summary": "The primary goal of this study is to investigate metabolic changes and maintaining efficacy in stabilized patients with bipolar disorders who have pharmacologically induced weight gain.", + "NCTID": "NCT00845988", + "total_score": 0.18367496998799518, + "bm25_score": 0.06797168867547018, + "medcpt_score": 0.115703281312525 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-20148", + "patient": "<0.> A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. <1.> Neurologic examination confirms severe cognitive deficits and memory dysfunction. <2.> An electroencephalogram shows generalized periodic sharp waves. <3.> Neuroimaging studies show moderately advanced cerebral atrophy. <4.> A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration. <5.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT01519271", + "brief_title": "Mild Cognitive Impairment in Parkinson's Disease", + "phase": "Phase 4", + "drugs": "['Exelon Patch (rivastigmine transdermal system)', 'Placebo Patches']", + "drugs_list": [ + "Exelon Patch (rivastigmine transdermal system)", + "Placebo Patches" + ], + "diseases": "[\"Parkinson's Disease\", 'Mild Cognitive Impairment']", + "diseases_list": [ + "Parkinson's Disease", + "Mild Cognitive Impairment" + ], + "enrollment": "28.0", + "inclusion_criteria": "inclusion criteria: \n\n Participants must be experiencing symptoms of mild cognitive impairment; this will be determined by study personnel. \n\n Participants must be on a sable medication regimen for 2 months prior to starting the study (necessary dose adjustments during the study are acceptable). \n\n Participants are capable of giving informed consent supported by not meeting Parkinson's disease Dementia criteria; this will be determined by study personnel. \n\n ", + "exclusion_criteria": ": \n\n Active suicide ideation. \n\n Weighing less than 100 lbs (45 kgs). \n\n History of Deep Brain Stimulation surgery. \n\n Diagnosis of Dementia \n\n Taking certain types of medications may be an ", + "brief_summary": "Mild cognitive impairment, including difficulty with solving problems, planning, attention, or recalling information, can be a significant problem for individuals with Parkinson's disease. Even mild cognitive difficulties can lead to worse functioning, quality of life, depression, and difficulty for caregivers. Thus, ideally treatment at this stage would improve both cognitive symptoms and some of the other problems associated with these symptoms.~Despite the fact that mild cognitive impairment is a serious problem for Parkinson's disease patients little is known about how best to treat it. This study is a 24-week clinical trial to see if a Food and Drug Administration (FDA)-approved drug, the Exelon (rivastigmine) Patch, is useful in treating mild cognitive impairment in patients with Parkinson's disease. Currently, the Exelon (rivastigmine) Patch is FDA-approved for the treatment of mild to moderate dementia in Alzheimer and Parkinson's disease patients.", + "NCTID": "NCT01519271", + "total_score": 0.16173429520608676, + "bm25_score": 0.04289236449440817, + "medcpt_score": 0.11884193071167862 + }, + { + "nct_id": "NCT01628315", + "brief_title": "Assessment of Lesion Activity Analysis in the Avonex- Steroid Azathioprine (ASA) Study", + "phase": "", + "drugs": "['MRI']", + "drugs_list": [ + "MRI" + ], + "diseases": "['Multiple Sclerosis, Relapsing-remitting']", + "diseases_list": [ + "Multiple Sclerosis", + "Relapsing-remitting" + ], + "enrollment": "159.0", + "inclusion_criteria": "inclusion criteria: \n\n Enrolled into the 2-year, double-blind, placebo-controlled ASA study and entered 3 year extension study \n\n MRI was performed on all patients using a 1.5 T magnet \n\n ", + "exclusion_criteria": ": \n\n MRI images unable to be processed \n\n All 5 MRI time points not collected", + "brief_summary": "To examine short- and long-term value of appearance of new active lesions in predicting extent of cortical and subcortical deep gray matter (SDGM) atrophy over 5 years in ASA (Avonex- Steroid-Azathioprine)study.~To explore how accumulation of cortical and SDGM atrophy over 5 years differs with respect to the number of new active lesions or amount of disease activity, in early relapsing-remitting multiple sclerosis (RRMS) patients who did or did not develop sustained disability progression.~To examine the relationship between development of cortical and SDGM atrophy and regional likelihood of development of new active lesions over 5 years.", + "NCTID": "NCT01628315", + "total_score": 0.15069432604388813, + "bm25_score": 0.04411255411255411, + "medcpt_score": 0.10658177193133397 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-20149", + "patient": "<0.> A 43-year-old woman visits her dermatologist for lesions on her neck. <1.> On examination, multiple lesions are seen. <2.> Each lesion is small soft, and pedunculated. <3.> The largest lesion is about 4 mm in diameter. <4.> The color of different lesions varies from flesh colored to slightly hyperpigmented. <5.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT01950026", + "brief_title": "Temperature Skin Check After Cryotherapy Application", + "phase": "Phase 3", + "drugs": "['cryotherapy application']", + "drugs_list": [ + "cryotherapy application" + ], + "diseases": "['Body Temperature Changes']", + "diseases_list": [ + "Body Temperature Changes" + ], + "enrollment": "24.0", + "inclusion_criteria": "inclusion criteria: \n\n belong to ethnic groups requested \n\n ", + "exclusion_criteria": ": \n\n suffering any change in skin sensitivity, illness of an infectious nature or previously diagnosed diseases that respond negatively to the use of cold", + "brief_summary": "The aim of this study was to reheat the skin in different ethnic groups after application of cryotherapy.", + "NCTID": "NCT01950026", + "total_score": 0.12529644268774703, + "bm25_score": 0.05862977602108037, + "medcpt_score": 0.06666666666666667 + }, + { + "nct_id": "NCT02615912", + "brief_title": "A Single-Center, Exploratory Study to Analyze the Dynamics of Skin Microflora Following Exposure to Surfactants", + "phase": "", + "drugs": "['PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5%', 'Lauryl glucoside (Plantacare\u00ae 1200UP, BASF) 1.5%', 'Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5%', 'Silwet* DA-63 (Momentive) 1.5%', 'Sodium lauryl sulfate (Sigma Aldrich) 1.0%', 'Water (control)']", + "drugs_list": [ + "PEG-40 Hydrogenated Castor Oil (Tagat CH40", + "Evonik) 1.5%", + "Lauryl glucoside (Plantacare\u00ae 1200UP", + "BASF) 1.5%", + "Sorbitan palmitate (SPANTM 40 (powder)", + "Croda) 1.5%", + "Silwet* DA-63 (Momentive) 1.5%", + "Sodium lauryl sulfate (Sigma Aldrich) 1.0%", + "Water (control)" + ], + "diseases": "['Dermatitis']", + "diseases_list": [ + "Dermatitis" + ], + "enrollment": "24.0", + "inclusion_criteria": "inclusion criteria: \n\n Healthy Subjects with Fitzpatrick Skin Types I, II or III \n\n ", + "exclusion_criteria": ": \n\n Subjects with visible skin disease, tattoos, skin condition, or abnormal skin color", + "brief_summary": "The purpose of this study is to understand the changes in skin microflora, skin barrier function, and skin biochemical constituents in response to direct contact with model surfactants used in personal care articles. The results from this study will provide insights into the complex interaction between the skin microbiome and the epidermis after exposure to surfactants.", + "NCTID": "NCT02615912", + "total_score": 0.12304724261246, + "bm25_score": 0.05486542443064182, + "medcpt_score": 0.06818181818181818 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201410", + "patient": "<0.> A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. <1.> She is now complaining of a cool right foot. <2.> Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. <3.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT02264964", + "brief_title": "Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis", + "phase": "", + "drugs": "['GamCath\u00ae', 'Arteriovenous fistula creation', 'GamCath\u00ae', 'Arteriovenous fistula creation']", + "drugs_list": [ + "GamCath\u00ae", + "Arteriovenous fistula creation", + "GamCath\u00ae", + "Arteriovenous fistula creation" + ], + "diseases": "['Renal Failure Chronic Requiring Hemodialysis', 'Central Venous Catheterization', 'Inadequate Hemodialysis Blood Flow', 'Venous Stenosis', 'Venous Thrombosis', 'Infection Due to Central Venous Catheter', 'Central Venous Catheter Thrombosis']", + "diseases_list": [ + "Renal Failure Chronic Requiring Hemodialysis", + "Central Venous Catheterization", + "Inadequate Hemodialysis Blood Flow", + "Venous Stenosis", + "Venous Thrombosis", + "Infection Due to Central Venous Catheter", + "Central Venous Catheter Thrombosis" + ], + "enrollment": "1400.0", + "inclusion_criteria": "inclusion criteria: \n\n Chronic renal failure requiring hemodialysis. \n\n No medical history of central vena catheterization. \n\n Maintenance hemodialysis after central vena catheterization. \n\n Signed informed consent. \n\n ", + "exclusion_criteria": ": \n\n Had been performed central venous puncture or catheterization before. \n\n Can not use heparin. \n\n Refused to sign the informed consent. \n\n Advanced cancer patients. \n\n With or will take arteriovenous fistula surgery in right arm. \n\n Other inappropriate situation", + "brief_summary": "The duration and adverse events of non-cuffed catheter in patients with hemodialysis will be investigated by multicenter prospective cohort. Totally, 1,400 patients with chronic renal failure requiring hemodialysis will be enrolled. 900 patients will be given right internal jugular catheterization, and the other 500 patients unsuitable for right internal jugular catheterization will receive femoral catheterizations. Every patient will be followed-up for six months. During following-up period, the duration time and adverse events of non-cuffed catheter will be recorded in details, including inadequate hemodialysis blood flow, venous stenosis, venous thrombosis, infection, catheter thrombosis and so on. The central vein will be evaluated by CT Angiography to identify its stenosis at last visit after 6 months. This multicentre trial will provide evidence to develop guideline for duration time of using non-cuffed catheter.", + "NCTID": "NCT02264964", + "total_score": 0.18726930069948128, + "bm25_score": 0.08832503974013407, + "medcpt_score": 0.09894426095934718 + }, + { + "nct_id": "NCT02097186", + "brief_title": "Preconditioning Shields Against Vascular Events in Surgery", + "phase": "", + "drugs": "['Remote ischaemic preconditioning']", + "drugs_list": [ + "Remote ischaemic preconditioning" + ], + "diseases": "['Abdominal Aortic Aneurysm', 'Carotid Atherosclerosis', 'Critical Lower Limb Ischaemia']", + "diseases_list": [ + "Abdominal Aortic Aneurysm", + "Carotid Atherosclerosis", + "Critical Lower Limb Ischaemia" + ], + "enrollment": "400.0", + "inclusion_criteria": "inclusion criteria: \n\n Age greater than 18 years \n\n Patient willing to give full informed consent for participation \n\n Patients undergoing elective carotid endarterectomy or \n\n Patients undergoing open abdominal aortic aneurysm repair or \n\n Patients undergoing endovascular abdominal aneurysm repair or \n\n Patients undergoing surgical lower limb revascularisation (suprainguinal or infrainguinal) \n\n ", + "exclusion_criteria": ": \n\n Pregnancy \n\n Significant upper limb peripheral arterial disease \n\n Previous history of upper limb deep vein thrombosis \n\n Patients on glibenclamide or nicorandil (these medications may interfere with RIPC) Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2 \n\n Patients with a known history of myocarditis, pericarditis or amyloidosis \n\n Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2. \n\n Patients with severe hepatic disease defined as an international normalised ratio >2 in the absence of systemic anticoagulation \n\n Patients with severe respiratory disease (for the trial, defined as patients requiring home oxygen therapy) \n\n Patients previously enrolled in the trial representing for a further procedure \n\n Patients with previous axillary surgery", + "brief_summary": "Major vascular surgery involves operations to repair swollen blood vessels, clear debris from blocked arteries or bypass blocked blood vessels. Patients with these problems are a high-risk surgical group as they have generalized blood vessel disease. These puts them at risk of major complications around the time of surgery such as heart attacks , strokes and death. The mortality following repair of a swollen main artery in the abdomen is about 1 in 20. This contrasts poorly with the 1 per 100 risk of death following a heart bypass. Simple and cost-effective methods are needed to reduce the risks of major vascular surgery. Remote ischaemic preconditioning (RIPC) may be such a technique. To induce RIPC, the blood supply to muscle in the patient's arm is interrupted for about 5 minutes. It is then restored for a further five minutes. This cycle is repeated three more times. The blood supply is interrupted simply by inflating a blood pressure cuff to maximum pressure. This repeated brief interruption of the muscular blood supply sends signals to critical organs such as the brain and heart, which are rendered temporarily resistant to damage from reduced blood supply. Several small randomized clinical trials in patients undergoing different types of major vascular surgery have demonstrated a potential benefit. This large, multi-centre trial aims to determine whether RIPC can reduce complications in routine practice.", + "NCTID": "NCT02097186", + "total_score": 0.17500862663906142, + "bm25_score": 0.06386144049187527, + "medcpt_score": 0.11114718614718616 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201411", + "patient": "<0.> A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. <1.> She denies trauma. <2.> On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. <3.> Her body temperature is normal and her blood pressure is 80/60. <4.> Her right arm has no discoloration or movement limitation. <5.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT01723137", + "brief_title": "Measuring Changes in Acute Pain in the Emergency Department Using Patient Reported Scales", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Acute Pain']", + "diseases_list": [ + "Acute Pain" + ], + "enrollment": "3630.0", + "inclusion_criteria": "inclusion criteria: \n\n Reported pain greater than or equal to 3 out of 10 \n\n ", + "exclusion_criteria": ": \n\n Less than 18 years of age \n\n Decreased level of consciousness \n\n Inability to answer questions \n\n Prisoner", + "brief_summary": "Patient reported pain, stress, and anxiety measures have been found to be inter-related, but it is not known if they are all associated with receiving opiate medications. The objective of this study is to determine if patients' degree of reported pain, stress, or anxiety is associated with receiving opiate pain medications in the emergency department or at discharge. Alert patients at least 18 years of age and who report pain greater than 3/10 are eligible to participate in the study. Consenting patients complete Visual Analog Scales describing their perceived pain, stress, and anxiety from enrollment until discharge. Demographic data and administration of pain medication is also recorded. Visual Analog Scale scores among patients who received an opioid pain medicine in the emergency department and at discharge will be compared to those who did not.", + "NCTID": "NCT01723137", + "total_score": 0.12774765811178848, + "bm25_score": 0.06347520585242203, + "medcpt_score": 0.06427245225936644 + }, + { + "nct_id": "NCT01526382", + "brief_title": "Use of PiCCO System in Critically Ill Patients With Septic Shock and Acute Respiratory Distress Syndrome", + "phase": "Phase 1; Phase 2", + "drugs": "['PiCCO monitoring (PULSION)', 'central venous catheter']", + "drugs_list": [ + "PiCCO monitoring (PULSION)", + "central venous catheter" + ], + "diseases": "['Septic Shock', 'Acute Respiratory Distress Syndrome']", + "diseases_list": [ + "Septic Shock", + "Acute Respiratory Distress Syndrome" + ], + "enrollment": "350.0", + "inclusion_criteria": "inclusion criteria: \n\n Patients were included if they were diagnosed with Shock, Acute respiratory distress syndrome (ARDS), or both. \n\n Shock was defined by the presence 4 criteria: \n\n Heart rate of at least 90/min; \n\n A respiratory rate of at least 20/min or a PaCO2 of 32mmHg or lower or the use of mechanical ventilation; \n\n The use of vasopressors to maintain a systolic blood pressure of at least 90mmHg despite fluid resuscitation, low dose of dopamine (\u2264 5 \u03bcg/kg per minute), or dobutamine; \n\n at least 1 of 3 signs of hypoperfusion (urine output < 0.5mL/kg of body weight per hour for 1 hour or more; neurologic dysfunction defined by confusion, psychosis, or a Glasgow coma scale score of \u2264 6; plasma lactate higher than the upper limit of the normal value). \n\n Acute respiratory distress syndrome\uff1a \n\n the presence of acute decrease in PaO2/FIO2 to 200mmHg or lower, \n\n bilateral pulmonary infiltrates or a chest radiograph consistent with edema; \n\n no clinical evidence of left atrial hypertension; and requirement for positive pressure ventilation. \n\n ", + "exclusion_criteria": ": \n\n Patients were moribund. \n\n signed do-not-resuscitation odor.", + "brief_summary": "PiCCO has been widely used in critical care settings for several decades. Together with pulmonary artery catheter, it is regarded as the important tool for guiding fluid management in patients with shock or acute respiratory distress syndrome. However, its effects on patients' outcome remain untested. The investigators study is a pilot study that is designed to test whether the use of PiCCO will improve patients' outcome, as compared to those without PiCCO monitoring.", + "NCTID": "NCT01526382", + "total_score": 0.12627462362249298, + "bm25_score": 0.045028271209473884, + "medcpt_score": 0.08124635241301909 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201412", + "patient": "<0.> A 25-year-old woman presents to the clinic complaining of prolonged fatigue. <1.> She denies difficulty sleeping and sleeps an average of 8 hours a night. <2.> She also notes hair loss, a change in her voice and weight gain during the previous 6 months. <3.> She complains of cold intolerance. <4.> On examination she has a prominent, soft, uniform anterior cervical mass at the midline. <5.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT01551498", + "brief_title": "Evaluating the Dietary Supplement Anatabloc in Thyroid Health-ASAP (Antabloc Supplementation Autoimmune Prevention)", + "phase": "Phase 2", + "drugs": "['Anatabloc Supplement', 'Placebo']", + "drugs_list": [ + "Anatabloc Supplement", + "Placebo" + ], + "diseases": "['Thyroiditis, Autoimmune']", + "diseases_list": [ + "Thyroiditis", + "Autoimmune" + ], + "enrollment": "165.0", + "inclusion_criteria": "inclusion criteria: \n\n adults 18-70 years of age \n\n having positive antibodies against thyroid peroxidase \n\n having sonographic evidence consistent with a diagnosis of Hashimoto's thyroiditis \n\n ", + "exclusion_criteria": ": \n\n having evidence of end-stage thyroiditis \n\n being a current smoker or smokeless tobacco user \n\n be taking systemic glucocorticoids, interferon-alpha, anti-CD20 antibody, or anti-CTLA-4 antibody \n\n be taking any medication for treatment of autoimmune thyroiditis other than L-thyroxine or equivalent", + "brief_summary": "This is a study to evaluate the safety, tolerability, and potential effects of Anatabloc dietary supplementation on antithyroid autoantibodies, thyroid structure, and thyroid function in subjects with autoimmune thyroiditis.", + "NCTID": "NCT01551498", + "total_score": 0.11910684915393695, + "bm25_score": 0.028639182945905634, + "medcpt_score": 0.09046766620803132 + }, + { + "nct_id": "NCT00271427", + "brief_title": "Selenium Treatment in Autoimmune Thyroiditis (AIT)", + "phase": "", + "drugs": "['L-Selenomethionine']", + "drugs_list": [ + "L-Selenomethionine" + ], + "diseases": "['Autoimmune Thyroiditis', 'Hashimotos Thyroiditis']", + "diseases_list": [ + "Autoimmune Thyroiditis", + "Hashimotos Thyroiditis" + ], + "enrollment": "100.0", + "inclusion_criteria": "inclusion criteria: \n\n Clinically approved AIT patients who do not use any medication other than LT4 to keep TSH in the lower half of normal range. \n\n ", + "exclusion_criteria": ": \n\n Any kind of drug use other than LT4 or any kind of known pathology which may effect GIS absorption.", + "brief_summary": "Selenium suppresses autoimmune destruction of thyrocytes and decreases titers of serum TPOAb in AIT patients. Older 4 clinical trials approved the efficacy of the daily dose of 200micg. It's believed that Se saturates the deficient stores of GPX so GPX saves the thyrocytes against to oxidative stresses. Although less than 70 micg/d is sufficient to maximize GPX activity, none of the authors tested the doses less than 200 micg/d. Our hypothesis was that If 100 micg/d can not suppress the TPOAb titers,it means autoimmune destruction can not be blocked by saturation of deficient stores of GPX solely and the mechanism of action requires more than repletion of deficient stores. It's important not only to estimate the optimal dose but to understand the mechanism of action. High dose therapy may also suppress TPOAb levels in Se-non-deficient AIT patients, if it is so, Se therapy may becomes the solely treatment modality which can suppress the autoimmunity in more than 400 million AIT patients. Because there've been no way to suppress autoimmune war and replacement of LT4 had been the only treatment modality for palliation. An other independent part of the study is to test the effect of Se in adolescent AIT patients.", + "NCTID": "NCT00271427", + "total_score": 0.11242589953653903, + "bm25_score": 0.028665952586936917, + "medcpt_score": 0.08375994694960211 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201413", + "patient": "<0.> A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. <1.> She has had no health problems in the past besides 2 natural abortions. <2.> She had given birth to a healthy child 3 weeks before. <3.> On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. <4.> Otherwise, physical examination is unremarkable. <5.> Her chest x-ray and CBC are normal. <6.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT02264769", + "brief_title": "Carbetocin at Elective Cesarean Delivery Part 4", + "phase": "", + "drugs": "['Carbetocin']", + "drugs_list": [ + "Carbetocin" + ], + "diseases": "['Postpartum Hemorrhage']", + "diseases_list": [ + "Postpartum Hemorrhage" + ], + "enrollment": "110.0", + "inclusion_criteria": "inclusion criteria: \n\n Elective cesarean delivery under spinal anesthesia. \n\n Written informed consent to participate in this study. \n\n Term pregnancy \n\n ", + "exclusion_criteria": ": \n\n Refusal to give written informed consent. \n\n Allergy or hypersensitivity to carbetocin or oxytocin. \n\n Conditions that predispose to uterine atony and postpartum hemorrhage, such as placenta previa, multiple gestation, preeclampsia, eclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis. \n\n Hepatic, renal, and vascular disease.", + "brief_summary": "PostPartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly used uterotonic drug to prevent and treat PPH in North America. However oxytocin has a very short duration of action, requiring a continuous infusion to achieve sustained uterotonic activity. Moreover large doses are associated with adverse effects like hypotension, nausea, vomiting, dysrhythmias and ST changes. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recommended a single dose of 100 mcg of carbetocin at elective cesarean delivery to promote uterine contraction. In three studies recently performed at Mount Sinai Hospital, the investigators have found no difference in uterine contractility between the doses of 20- 120 mcg carbetocin and that the ED90 is 14.8 mcg. Thus a larger trial comparing the minimum effective dose determined in the previous three trials with the standard 100 mcg dose is necessary to confirm these findings.", + "NCTID": "NCT02264769", + "total_score": 0.1337657435611493, + "bm25_score": 0.06016189145119963, + "medcpt_score": 0.07360385210994969 + }, + { + "nct_id": "NCT00163709", + "brief_title": "BNP Testing in Patients With SOB on Presentation to ED", + "phase": "Phase 1", + "drugs": "['BNP test']", + "drugs_list": [ + "BNP test" + ], + "diseases": "['Heart Failure, Congestive']", + "diseases_list": [ + "Heart Failure", + "Congestive" + ], + "enrollment": "600.0", + "inclusion_criteria": "inclusion criteria: \n\n We plan to include all patients presenting to the ED with shortness of breath that are over 40 years old and present with an emergency department triage category of 3 or higher. \n\n ", + "exclusion_criteria": ": \n\n Patients presenting with a traumatic cause of dyspnea, patients with severe renal disease (serum creatinine level of more than 250 micro mmol/L, patients with cardiogenic shock, and patients who have an early transfer to another hospital (within 24 hrs) will be excluded.", + "brief_summary": "A trial to examine whether a new heart failure blood test can improve the outcome of patients presenting to the Emergency Department with shortness of breath.~We hypothesise that a BNP test performed in real-time in patients presenting to the Emergency Department with shortness of breath will help identify additional patients with CHF and consequently to change practice and allow more patients to recieve correct treatment earlier.", + "NCTID": "NCT00163709", + "total_score": 0.1331789595646063, + "bm25_score": 0.06808375018052437, + "medcpt_score": 0.06509520938408189 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201414", + "patient": "<0.> An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. <1.> In the last 3 days he stopped walking and eating by himself. <2.> He has had no fever, cough, rash or diarrhea. <3.> His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time. <4.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT01624545", + "brief_title": "To Scan or Not to Scan: The Role of Follow-up CT Scanning for Management of Chronic Subdural Hematoma After Neurosurgical Evacuation", + "phase": "", + "drugs": "['cranial CT scan']", + "drugs_list": [ + "cranial CT scan" + ], + "diseases": "['Chronic Subdural Hematoma']", + "diseases_list": [ + "Chronic Subdural Hematoma" + ], + "enrollment": "368.0", + "inclusion_criteria": "inclusion criteria: \n\n Newly diagnosed chronic subdural hematoma by CT scan or MRI, operated within the last 48 hours \n\n Age 18 years or older \n\n Written informed consent from the patient to participate in the study \n\n ", + "exclusion_criteria": " \n\n Moribund state of health prohibiting surgery \n\n Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad) \n\n Recurrent hematoma if the first surgery was performed before study start \n\n CSH due to spontaneous spinal CSF fistula or meningeosis carcinomatosa \n\n Pregnancy \n\n Patient with Metastatic Disease and a high possibility to pass away in the next 6 month", + "brief_summary": "Chronic subdural hematoma (CSH) is one of the most common bleedings of the head. These hematomas develop after minor head trauma and increase in size over weeks. Patients usually present with headaches, gait disturbances, language problems or confusion. The state of the art treatment of a symptomatic chronic subdural hematoma is to remove the hematoma by burr hole trepanation.~The optimal follow-up for operated patients remains controversial. Due to the known high rate of a second hematoma at the same place (usually within weeks), one strategy is to perform serial computer tomography scans in order to identify recurrent hematomas early. The radiologic evidence of a second hematoma often leads to reoperation, even if the patient has no, or just slight symptoms. Another strategy after surgical hematoma evacuation is to closely follow the patient with neurological examinations and perform neuroimaging only in case of new symptoms. Advocators of this strategy argue that a follow-up with routine CT scans may be harmful due to additional and maybe unnecessary surgeries and hospital days in a patient population marked by advanced age and fragility.~The aim of the current study is to evaluate the role of computer tomography scanning in the postoperative follow-up after removal of a chronic subdural hematoma. Participants of this study will be allocated by chance to one of two study groups: Patients allocated to group A will receive a computer tomography scan on day 2 and again on day 30 after surgery in addition to a clinical examination. Patients allocated to group B will be examined clinically on day 2 and day 30 without computer tomography. All patients will undergo a final clinical examination after 6 months. The study will recruit 400 patients.", + "NCTID": "NCT01624545", + "total_score": 0.11066547809258392, + "bm25_score": 0.038913341340447175, + "medcpt_score": 0.07175213675213676 + }, + { + "nct_id": "NCT01869855", + "brief_title": "A Prospective Randomized Study Evaluating the Recurrence Rate of Chronic Subdural Hematoma After Placing a Subperiosteal Drainage Compared to a Subdural Drainage", + "phase": "", + "drugs": "['Subdural Drainage', 'Subperiosteal Drainage']", + "drugs_list": [ + "Subdural Drainage", + "Subperiosteal Drainage" + ], + "diseases": "['Chronic Subdural Hematoma']", + "diseases_list": [ + "Chronic Subdural Hematoma" + ], + "enrollment": "220.0", + "inclusion_criteria": "inclusion criteria: \n\n Patient at least 18 years of age presenting with a symptomatic chronic subdural hematoma \n\n Chronic subdural hematoma verified on cranial CT or MRI \n\n ", + "exclusion_criteria": ": \n\n The surgeon decides based on intraoperative conditions to perform a craniotomy (e.g. acute hematoma indicating a craniotomy) \n\n Chronic subdural hematoma caused by another underlying illness (e.g. caused by over-drainage of a vp-shunt) \n\n no informed consent", + "brief_summary": "The aim of our study is to investigate in randomized controlled fashion whether the recurrence and complication rate, after insertion of subperiosteal drainage in the treatment of chronic subdural haematoma, is higher compared to insertion of subdural drainage.~We hypothesize that patients treated with a subperiosteal drainage do not show higher recurrence rates than those treated with a subdural drainage, and suffer less complications.", + "NCTID": "NCT01869855", + "total_score": 0.08203583684804341, + "bm25_score": 0.03813405961293285, + "medcpt_score": 0.043901777235110566 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201415", + "patient": "<0.> A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. <1.> The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. <2.> The complete blood count and biochemical profile are normal. <3.> Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. <4.> The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. <5.> The differential diagnosis includes vesicular mole vs fibroid degeneration. <6.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT00180739", + "brief_title": "Safety Trial of Magnetic Resonance (MR) Guided Focused Ultrasound Surgery (FUS) in Women With Uterine Fibroids Wishing to Pursue Pregnancy in the Future", + "phase": "Phase 4", + "drugs": "['Magnetic Resonance Guided Focused Ultrasound']", + "drugs_list": [ + "Magnetic Resonance Guided Focused Ultrasound" + ], + "diseases": "['Uterine Fibroids', 'Pregnancy']", + "diseases_list": [ + "Uterine Fibroids", + "Pregnancy" + ], + "enrollment": "60.0", + "inclusion_criteria": "inclusion criteria: \n\n 1. Subject with uterine fibroids, who desire pregnancy within 12 months and has the one of the following criteria: Women 20-40 age. Women age < 46 years old who plan to have egg donation. Women above 38 should test for normal ovarian function as judged by endocrinological evaluation. \n\n If the couple has failed to conceive for more that 1 year, the woman should test for normal ovarian function as judged by endocrinological evaluation, and the male must have adequate sperm test. \n\n Women undergoing fertility treatment or plan to have sperm donation. \n\n 2. Use or non use of non-steroidal treatments for excessive vaginal bleeding such as antifibrinolytic agents (e.g. Tranexamic acid) or non-steroidal anti-inflammatory drugs (e.g. Mefanamic Acid) has been maintained for the three months prior to the planned date of the study procedure and the patient has agreed to maintain this use or non-use through the 6-month follow-up period. \n\n 3. Clinically normal PAP smear within timing of National Guidelines in the country of the clinical site. \n\n 4. Able and willing to give consent and able to attend all study visits \n\n 5. Able to communicate sensations during the MRgFUS procedure \n\n 6. Having uterine fibroids that are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone). \n\n 7. Tumor(s) are clearly visible on non-contrast MRI. \n\n 8. Largest fibroid 8 cm in diameter or 12 cm if receiving GnRH \n\n ", + "exclusion_criteria": ": \n\n 1. Patient is pregnant as confirmed by pregnancy test at time of screening \n\n 2. Uterine size >20 weeks as evaluated by US or MR. \n\n 3. Patients who are considered high risk pregnancy due to uterine factors (e.g. abnormal uterus, uterine scars, cerclage) except fibroids. \n\n 4. Patients with fibroid that is more than 50% sub-mucosal or with hysteroscopically resectable \n\n 5. Patients with adenomyosis \n\n 6. Patient is on dialysis \n\n 7. Hematocrit is < 25 \n\n 8. Patient has hemolytic anemia \n\n 9. Patient has unstable cardiac status including: \u00a7 Unstable angina pectoris on medication\u00a7 Documented myocardial infarction within 6 months of protocol entry\u00a7 Congestive heart failure requiring medication (other than diuretic)\u00a7 Currently taking anti-arrhythmic drugs\u00a7 Severe hypertension (diastolic BP>100 on medication)\u00a7 Presence of cardiac pacemaker \n\n 10. Patient has an ASA score of >2 \n\n 11. Patient has severe cerebrovascular disease (multiple CVA or CVA within 6 months) \n\n 12. Patient is on anti-coagulation therapy or has an underlying bleeding disorder \n\n 13. Evidence of uterine pathology other than leiomyoma \n\n 14. Patient has an active pelvic infection or history of pelvic inflammatory disease \n\n 15. Patient has an undiagnosed pelvic mass outside the uterus. \n\n 16. Patient weight >110 kg \n\n 17. Subject with extensive abdominal scarring in an area of the abdomen directly anterior to the treatment area. \n\n 18. Subject with standard contraindications for MR imaging such as non-MRI compatable implanted metallic devices. \n\n 19. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist). \n\n 20. Individuals who are not able or willing to tolerate the required prolonged stationary prone position during treatment (approximately 3 hours.) \n\n 21. Patient with an intrauterine contraceptive device anywhere in the treatment beam path. \n\n 22. Women who are breast feeding. \n\n 23. Five or more fibroids, bigger then 3cm diameter, each", + "brief_summary": "The study objective is to develop data for the safety of pregnancies after thermal ablation of uterine fibroids by MR guided Focused Ultrasound using the Ex Ablate 2000 system.", + "NCTID": "NCT00180739", + "total_score": 0.1984213075046053, + "bm25_score": 0.0872234699154634, + "medcpt_score": 0.11119783758914194 + }, + { + "nct_id": "NCT00277680", + "brief_title": "Laparoscopic Occlusion of Uterine Vessels Compared to Uterine Fibroid Embolization for Treatment of Uterine Fibroids", + "phase": "", + "drugs": "['Laparoscopic bilateral occlusion of uterine artery', 'Radiological embolization (UFE)']", + "drugs_list": [ + "Laparoscopic bilateral occlusion of uterine artery", + "Radiological embolization (UFE)" + ], + "diseases": "['Uterine Fibroids']", + "diseases_list": [ + "Uterine Fibroids" + ], + "enrollment": "60.0", + "inclusion_criteria": "inclusion criteria: \n\n Menorrhagia and/or bulk symptoms associated with uterine fibroids \n\n ", + "exclusion_criteria": ": \n\n Malignancy \n\n Current or planned pregnancy \n\n Small submucous fibroids suitable for hysteroscopic resection \n\n Postmenopausal women \n\n Suspected or known adenomyosis \n\n Uterus size exceeding the umbilical level \n\n Contraindications against laparoscopic surgery", + "brief_summary": "Women with symptomatic uterine fibroids are treated either by Uterine Fibroid Embolization (UFE) or laparoscopic occlusion. The study hypothesis is that laparoscopic occlusion of uterine vessels and UFE have equal effect on bleeding symptoms. Menstrual bleeding reduction six months after treatment is the main endpoint. Secondary endpoints include participants assessment of symptom relief, and volume reduction of fibroids measured by MRI. We will also investigate possible differences in postoperative course, symptom reduction, complication, and recurrence. Patients are controlled with regular intervals up to five years after treatment.", + "NCTID": "NCT00277680", + "total_score": 0.1416364467602417, + "bm25_score": 0.04523592868475598, + "medcpt_score": 0.0964005180754857 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201416", + "patient": "<0.> A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. <1.> Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. <2.> She was prescribed NSAIDS and a topical muscle relaxant. <3.> She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. <4.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT02238756", + "brief_title": "Safety and Tolerability of CV8102 Alone and in Combination With a Rabies Virus Vaccine in Healthy Adults", + "phase": "Phase 1", + "drugs": "['CV8102', 'Rabipur', 'CV8102 + Rabipur']", + "drugs_list": [ + "CV8102", + "Rabipur", + "CV8102 + Rabipur" + ], + "diseases": "['Rabies']", + "diseases_list": [ + "Rabies" + ], + "enrollment": "72.0", + "inclusion_criteria": "inclusion criteria: \n\n Compliant with protocol procedures and available for clinical F/U until the protocol-defined end of the trial \n\n Physical examination and laboratory results without clinically significant findings \n\n Body Mass Index (BMI) \u2265 18.0 and \u2264 32.0 kg/m2 \n\n Subjects must use reliable forms of contraception (barrier method with spermicidal agent or true abstinence) and must refrain from sperm donation during treatment and the 4-week F/U period after the last treatment. \n\n ", + "exclusion_criteria": ": \n\n Use of any investigational or non-registered product (adjuvant, drug) other than CV8102 within 4 weeks preceding the administration of the CV8102, or planned use of any such agent during the trial period \n\n Subject has received any licensed or non-licensed vaccines within 4 weeks prior to the administration of CV8102 alone or in combination with the licensed rabies vaccine or planned vaccinations during the trial period \n\n Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of CV8102 alone or in combination with the licensed rabies vaccine. The use of inhaled and nasal steroids, as well as topical steroids outside the vaccination area, will be permitted \n\n Any medically diagnosed or suspected immune deficient condition based on medical history and physical examination \n\n History of autoimmune disease or suspected autoimmune disease based on medical history and physical examination that cannot be ruled out based on further examinations \n\n Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of CV8102 or licensed rabies vaccine \n\n Acute disease at the time of enrolment. Acute disease is defined as the presence of any acute condition including but not limited to non-febrile or febrile common colds, urinary tract infections, inflammatory, allergic or traumatic conditions that may interfere with safety assessment of the investigational products \n\n Presence or evidence of significant acute or chronic disease, in particular heart disease including coronary artery disease and chronic pulmonary diseases (e.g., chronic obstructive pulmonary disease [COPD]); uncontrolled medical or psychiatric illness (subjects with uncomplicated chronic diagnoses stable and treated for \u2265 3 months e.g., mild hypertension well-controlled with medication, may be enrolled - provided the condition and its therapy are known not to be associated with an immunocompromised state or an autoimmune disease) \n\n Major congenital defects \n\n Known allergy to any component (or closely related substance) of the licensed rabies vaccine product \n\n Known type I allergy to beta-lactam antibiotics \n\n Evidence of current alcohol or drug abuse \n\n History of any neurological disorders or seizures \n\n Known seropositivity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) (except in subjects previously vaccinated against HBV) or hepatitis C virus (HCV) \n\n Foreseeable non-compliance with protocol as judged by the Investigator \n\n History of any life-threatening anaphylactic reactions \n\n Subjects with impaired coagulation in whom an IM injection is contraindicated. \n\n Additional ", + "brief_summary": "The purpose of this clinical trial is to investigate the safety and tolerability of IM administered CV8102 and an IM administered combination of CV8102 and rabies vaccine in humans.", + "NCTID": "NCT02238756", + "total_score": 0.15448293667083082, + "bm25_score": 0.08771854152288934, + "medcpt_score": 0.06676439514794145 + }, + { + "nct_id": "NCT02374814", + "brief_title": "Immunogenicity of Rabies Vaccine for Pre Exposure Prophylaxis", + "phase": "Phase 4", + "drugs": "['Rabies vaccine', 'Placebo']", + "drugs_list": [ + "Rabies vaccine", + "Placebo" + ], + "diseases": "['Rabies']", + "diseases_list": [ + "Rabies" + ], + "enrollment": "60.0", + "inclusion_criteria": "inclusion criteria: \n\n Male and non-pregnant females aged \u2265 18 to \u2264 60 years on the day of inclusion Able to comprehend and give informed consent Able to attend all scheduled visits and to comply with all trial procedures Subject in good health, based on medical history and physical examination \n\n ", + "exclusion_criteria": ": \n\n Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post- menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination). \n\n Participation in the 4 weeks preceding the first trial vaccination, or planned participation during the present trial period, in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. \n\n Previous history of receiving the rabies vaccine. \n\n Previous history of receiving rabies immune globulin. \n\n Any major psychiatric disorder, such as severe depression, severe anxiety disorder, psychosis, schizophrenia, other major psychiatric disorders, or seizures. History of mild depression or anxiety disorder that is well controlled is not an ", + "brief_summary": "The purpose of this study is to compare the effectiveness of a two dose versus a three dose schedule and intramuscular versus intradermal injection for pre-exposure prophylaxis.", + "NCTID": "NCT02374814", + "total_score": 0.11968674860759448, + "bm25_score": 0.05494196831849271, + "medcpt_score": 0.06474478028910179 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201417", + "patient": "<0.> A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. <1.> The physical examination is remarkable for tenderness and positive Murphy sign. <2.> Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. <3.> Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. <4.> After surgery, the patient is taken to the ICU. <5.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT01745731", + "brief_title": "Cell Infusion Intraportal Autologous Bone Marrow Mononuclear as Enhancer of Liver Regeneration", + "phase": "Phase 2", + "drugs": "['Cell infusion intraportal mononuclear bone marrow autologous and portal embolization of the affected segments.']", + "drugs_list": [ + "Cell infusion intraportal mononuclear bone marrow autologous and portal embolization of the affected segments." + ], + "diseases": "['Liver Transplant Rejection']", + "diseases_list": [ + "Liver Transplant Rejection" + ], + "enrollment": "13.0", + "inclusion_criteria": "inclusion criteria: \n\n - Patients of both sexes aged \u2265 18 years. \n\n - Standard analytical parameters, defined by: \n\n Leukocytes \u2265 3000 \n\n Neutrophils \u2265 1500 \n\n Platelets \u2265 100,000 \n\n Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) \u2264 1.5 standard range institution \n\n creatinine \u2264 1.5 mg / dl \n\n - Patients with liver space occupying lesion (LOE) that require extended hepatic resection. \n\n Patient selection should be cautious, covering basically 5 types of liver damage which must be submitted prior to liver volumetry: \n\n Metastatic Disease subsidiary right hepatectomy extended to segment IV \n\n Metastatic Disease subsidiary right hepatectomy with suspected diseased liver (neoadjuvant chemotherapy) (in cases of doubt may be used liver function test indocyanine green) \n\n Bilobar liver metastases with multiple nodules in the right lobe and more than 3 nodules greater than 30 mm in the left hepatic lobe (LHI) will perform lumpectomies the LHI + right portal branch ligation (or postoperative percutaneous embolization) in order to make right hepatectomy 4-6 weeks (two stage surgery) \n\n Subsidiary Hepatocarcinoma extended right hepatectomy \n\n Liver Injury benign / malignant (Hemangiomas, hydatid cysts or liver tumors / primary bile hepatoblastoma), which by extension threatens the viability of the remaining liver tissue. \n\n 4 - Patients give their written informed consent for participation in the study and provide sufficient guarantees adherence to protocol according to the opinion of the investigator in charge of the patient care. \n\n ", + "exclusion_criteria": ": \n\n Different tumor records current disease or any disease hematologic. \n\n Patients with uncontrolled hypertension. \n\n Severe heart failure (NYHA IV). \n\n Patients with malignant ventricular arrhythmias or unstable angina. \n\n Diagnosis of deep vein thrombosis in the previous 3 months. \n\n Adjunctive therapy including hyperbaric oxygen, vasoactive substances, agents or angiogenesis inhibitors against Cox-II. \n\n BMI> 40 kg/m2. \n\n Patients with alcoholic with active alcoholism. \n\n Proliferative retinopathy. \n\n Concomitant disease that reduces life expectancy to less than a year. \n\n Difficulty in monitoring. \n\n Heart failure or ejection fraction (EF) <30%. \n\n Stroke or myocardial infarction within the last 3 months. \n\n Pregnant women or women of childbearing age who do not have adequate contraception.", + "brief_summary": "This is a randomized controlled trial in which the safety and feasibility of cell therapy medicinal product shall be measured by comparing the variables of the response after treatment compared to baseline prior to implementation. Secondarily the results obtained are compared with each of the study groups.~Patients will receive concomitant basic pharmacological treatment for maintaining liver function.~All patients will be equally medically treated. The hypothetic test is to propose mononuclear cells from the bone marrow infused in the territory hepatic portal remaining segments (II and III) to be performed while contralateral portal embolization provides progenitor cells hepatic regenerative capacity that would shorten the time of liver regeneration and increase residual volume, facilitating the realization of an extended hepatectomy with greater assurance of maintaining proper residual function and adequate surgical margins.", + "NCTID": "NCT01745731", + "total_score": 0.15022430137422693, + "bm25_score": 0.06348216820475965, + "medcpt_score": 0.0867421331694673 + }, + { + "nct_id": "NCT02556359", + "brief_title": "Consequences of DNA Repair and Telomere Defects on the Function of the Immune System: Application to CVID and Immune Deficiencies With Dysmorphic Syndromes", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Immune Deficiency and Early BMF in Childhood']", + "diseases_list": [ + "Immune Deficiency and Early BMF in Childhood" + ], + "enrollment": "100.0", + "inclusion_criteria": "inclusion criteria: \n\n Immune Deficiency and early BMF in childhood \n\n Common Variable Immunodeficiency (CVID) \n\n Genetic patients \n\n ", + "exclusion_criteria": ": \n\n Refusal to consent.", + "brief_summary": "The molecular mechanisms participating in the various aspects of the DNA Damage Response (DDR) are absolutely essential to maintain the genome dynamics essential to all living organisms. The most commonly studied consequence of faulty DDR is genome instability participating in cancer onset. In the present proposal, we wish to explore another aspect of DDR, not relevant to cancer, which is its absolute requirement at several key steps of the development, maturation, and function of the immune system.~The most spectacular consequences of faulty DNA repair processes with respect to the immuno-hematopoietic tissue are the complete block of B and T lymphocytes maturation owing to defective DNA joining phase during V(D)J recombination resulting in patients with Severe Combined Immune Deficiency (SCID).~The objectives of this study are to increase our knowledge on the role of the various DNA repair processes in the development, the maintenance, and the function of the immune system and thus, to better understand why and how dysfunctions of these DNA repair processes result in human severe conditions such as CVID, LOCID or other manifestations of immune disorders such as autoimmunity.~The explorations of DNA repair mechanisms in the patients will allow us to establish the genetic diagnosis in some patients with until now undefined molecular diagnosis. This is of immediate importance for the patients and their families, as it not only contributes to a better understanding of the patients' condition, but also allows providing genetic counseling for the families.", + "NCTID": "NCT02556359", + "total_score": 0.14828005942564287, + "bm25_score": 0.07657259090939351, + "medcpt_score": 0.07170746851624939 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201418", + "patient": "<0.> A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. <1.> On examination, he has generalized edema. <2.> His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. <3.> His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. <4.> Initial urinalysis shows specific gravity of 1.017. <5.> Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. <6.> His fractional excretion of sodium is 3.3%. <7.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT00557219", + "brief_title": "Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery", + "phase": "Phase 3", + "drugs": "['fenoldopam (Corlopam)', 'placebo', 'ketanserin (Sufrexal)']", + "drugs_list": [ + "fenoldopam (Corlopam)", + "placebo", + "ketanserin (Sufrexal)" + ], + "diseases": "['Acute Renal Failure']", + "diseases_list": [ + "Acute Renal Failure" + ], + "enrollment": "60.0", + "inclusion_criteria": "inclusion criteria: \n\n cardiac surgery \n\n at least one risk factor for acute renal failure: \n\n oliguria < 0.5 ml/kg/hour for over 3 hours despite adequate blood volume and furosemide intravenously \n\n at least 60 mg furosemide/12 hours iv to maintain diuresis > 1 ml/kg/hour \n\n ", + "exclusion_criteria": ": \n\n refused or none consent \n\n chronic renal failure with chronic renal replacement therapy \n\n chronic increase of serum creatinine > 2 mg/dl", + "brief_summary": "The purpose of the study is to compare the effect of fenoldopam and ketanserin on kidney function preservation in patients at high risk for renal failure after cardiac surgery. Acute, oliguric renal failure develops in up to 2% of patients undergoing cardiac surgery. Some of them require renal replacement therapy and despite that mortality in this group exceeds 30-60%. The investigators await that the use of fenoldopam and/or ketanserin may decrease the rate of severe renal failure.", + "NCTID": "NCT00557219", + "total_score": 0.1870771268807063, + "bm25_score": 0.08568261995225733, + "medcpt_score": 0.10139450692844892 + }, + { + "nct_id": "NCT01260883", + "brief_title": "Ketorolac in Postoperative Infants: Pharmacokinetics and Safety", + "phase": "Phase 3", + "drugs": "['Ketorolac Tromethamine 1 mg/kg', 'Ketorolac Tromethamine 0.5 mg/kg', 'Placebo']", + "drugs_list": [ + "Ketorolac Tromethamine 1 mg/kg", + "Ketorolac Tromethamine 0.5 mg/kg", + "Placebo" + ], + "diseases": "['Postoperative Pain in Infants']", + "diseases_list": [ + "Postoperative Pain in Infants" + ], + "enrollment": "77.0", + "inclusion_criteria": "inclusion criteria: \n\n Non-prematurely-born infants admitted to hospital following surgery ages 2-18 months, studied by age group 12-18 months, 6-12 months, < 6 months \n\n ", + "exclusion_criteria": ": \n\n Bleeding history in infant or family \n\n Coagulopathy \n\n Gastrointestinal bleeding history \n\n Renal or hepatic disease assessed by history and by pre-drug blood tests \n\n Premature birth (<36 weeks gestation)", + "brief_summary": "Infants handle ketorolac differently than adults. Study of handling of this pain medication given to infants following surgery. Detailed analysis of how the drug is eliminated from age 2 months to 18 months. Compared morphine use in infants who received the drug to the group getting placebo. Safety testing for kidney and liver function, breathing measured by continuous oximetry, and any bleeding issues.", + "NCTID": "NCT01260883", + "total_score": 0.15730835157666476, + "bm25_score": 0.0891154921534805, + "medcpt_score": 0.06819285942318425 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201419", + "patient": "<0.> A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. <1.> He first noticed difficulty swallowing meat. <2.> His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. <3.> He is able to locate the point where food is obstructed at the lower end of his sternum. <4.> He has lost a total of 25 pounds. <5.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT00256529", + "brief_title": "Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia", + "phase": "", + "drugs": "['EGD with biopsies']", + "drugs_list": [ + "EGD with biopsies" + ], + "diseases": "['Esophagitis']", + "diseases_list": [ + "Esophagitis" + ], + "enrollment": "483.0", + "inclusion_criteria": "inclusion criteria: \n\n Patients aged 18-90 presenting with dysphagia or food impaction \n\n Ability to undergo esophagogastroduodenoscopy and biopsies \n\n No significant cardiopulmonary disease, or other contraindication to EGD \n\n ", + "exclusion_criteria": ": \n\n Contradiction to EGD and/or biopsies such as Boerhaave's syndrome, or history or bleeding disorder or elevated INR \n\n Inability to provide informed consent \n\n Esophageal varices", + "brief_summary": "This is a prospective descriptive cross sectional study to determine the percentage of patients presenting with dysphagia who are found to have eosinophilic esophagitis (EoE) and to establish which presenting factors warrant esophageal biopsies. We hypothesize that a greater than expected percentage of patients who are biopsies will have histologic changes consistent with EE.", + "NCTID": "NCT00256529", + "total_score": 0.1842308908608885, + "bm25_score": 0.09480692772724797, + "medcpt_score": 0.08942396313364055 + }, + { + "nct_id": "NCT02509286", + "brief_title": "Perioperative Chemotherapy Compared To Neoadjuvant Chemoradiation in Patients With Adenocarcinoma of the Esophagus", + "phase": "Phase 3", + "drugs": "['5-Fluorouracil', 'Leucovorin', 'Oxaliplatin', 'Docetaxel', 'Carboplatin', 'Paclitaxel', 'Neoadjuvant radiation']", + "drugs_list": [ + "5-Fluorouracil", + "Leucovorin", + "Oxaliplatin", + "Docetaxel", + "Carboplatin", + "Paclitaxel", + "Neoadjuvant radiation" + ], + "diseases": "['Esophageal Adenocarcinoma (UICC TNM7)', 'Adenocarcinoma of the Esophagogastric Junction']", + "diseases_list": [ + "Esophageal Adenocarcinoma (UICC TNM7)", + "Adenocarcinoma of the Esophagogastric Junction" + ], + "enrollment": "438.0", + "inclusion_criteria": "inclusion criteria: \n\n Histologically verified adenocarcinoma of the esophagus according to the UICC definition (TNM7) \n\n Pre-treatment stage cT1N+, M0 or cT2-4a, N0/+, M0 \n\n Age \u226518 years \n\n No prior abdominal or thoracic radiotherapy \n\n ECOG Performance status 0-2 \n\n Adequate cardiac function ( Patients with a cardiac history (e.g. myocardial infarction, heart failure, coronary artery disease) should have a cardiology review) \n\n Adequate bone marrow function (WBC>3x10^9/l; Hb>9g/dl; platelets >100x10^9/l) \n\n Adequate respiratory function. Symptomatic Patients should have pulmonary function tests with FEV1 >65% of predicted) \n\n Adequate renal function (GFR >60ml/min) \n\n Adequate liver function (serum bilirubin <1.5x Upper level of Normal (ULN); AST <2.5x ULN and ALT <3x ULN (ULN as per institutional standard) \n\n written informed consent \n\n ", + "exclusion_criteria": ": \n\n Tumors of squamous or other non-adenocarcinoma histology \n\n Patients with advanced inoperable or metastatic esophageal adenocarcinoma \n\n Stage cT1N0 and cT4b \n\n Gastric carcinoma \n\n Prior chemotherapy for cancer, \n\n Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 months) \n\n Clinical significant lung disease (FEV1 <65% of predicted) \n\n Peripheral neuropathy Grade >1", + "brief_summary": "The trial is designed to investigate differences in outcome of patients with esophageal adenocarcinoma and junctional adenocarcinoma treated with perioperative (neoadjuvant + adjuvant) chemotherapy (FLOT) plus surgical resection versus neoadjuvant chemoradiation (CROSS) plus surgical resection.", + "NCTID": "NCT02509286", + "total_score": 0.1283047944318338, + "bm25_score": 0.055746966750023164, + "medcpt_score": 0.07255782768181063 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201420", + "patient": "<0.> A 32-year-old woman is admitted to the ER following a car accident. <1.> She has sustained multiple injuries including upper and lower extremity fractures. <2.> She is fully awake and alert, and she reports that she was not wearing a seat belt. <3.> Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. <4.> Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. <5.> She has no bowel sounds. <6.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT01594385", + "brief_title": "Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients", + "phase": "", + "drugs": "['Seprafilm']", + "drugs_list": [ + "Seprafilm" + ], + "diseases": "['Open Abdomen', 'Abdominal Adhesions', 'Trauma', 'Wounds and Injury']", + "diseases_list": [ + "Open Abdomen", + "Abdominal Adhesions", + "Trauma", + "Wounds and Injury" + ], + "enrollment": "30.0", + "inclusion_criteria": "inclusion criteria: \n\n Trauma patients undergoing DC/OA management for traumatic injury \n\n Age 18+ \n\n Life expectancy longer than 48 hours \n\n ", + "exclusion_criteria": ": \n\n Prisoners \n\n Pregnant patients \n\n Younger than 18 years of age", + "brief_summary": "The goal of this study is to test the effects of Seprafilm adhesion barrier on patients who are undergoing open abdomen damage control management for traumatic injuries when compared to no adhesion barrier use. Specifically, the researchers wish to study the effects of Seprafilm adhesion barrier on:~the number and intensity of adhesions,~whether there is any difference between treatment groups (Seprafilm vs. no Seprafilm) who go on to successful definitive abdominal closure,~rate of occurrence of secondary complications (such as abscesses) associated with short- and long-term beneficial effects of reducing adhesion formation,and~whether there is any difference between treatment groups regarding patient functional recovery.", + "NCTID": "NCT01594385", + "total_score": 0.16095574114675068, + "bm25_score": 0.07454477135342792, + "medcpt_score": 0.08641096979332273 + }, + { + "nct_id": "NCT02255487", + "brief_title": "Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections", + "phase": "", + "drugs": "['IrriSept System', 'No Intervention - Standard of Care (SoC) only']", + "drugs_list": [ + "IrriSept System", + "No Intervention - Standard of Care (SoC) only" + ], + "diseases": "['Surgical Site Infection']", + "diseases_list": [ + "Surgical Site Infection" + ], + "enrollment": "627.0", + "inclusion_criteria": "inclusion criteria: \n\n Is male or female, 18 years of age or older \n\n Has provided written informed consent or has surrogate consent provided by a Legally Authorized Representative (LAR) \n\n Has experienced abdominal trauma, blunt or penetrating, requiring open abdominal laparotomy with primary closure or \n\n Has experienced acute surgical abdomen requiring open abdominal laparotomy with primary closure \n\n ", + "exclusion_criteria": ": \n\n Known allergy to Chlorhexidine Gluconate (CHG) \n\n Estimated Abbreviated Injury Scale (AIS) score of six (6) at the time of surgery, for all trauma patients \n\n American Society of Anesthesiologists Physical Status Classification (ASA) score of five (5) or greater (As ASA scoring is a subjective measure, if the PI finds the patient stable enough for study participation despite a score of 5, enrollment may continue.) \n\n Female volunteers who are pregnant and/or breast feeding \n\n Damage control laparotomy \n\n Abdominal incision created prior to operating room (i.e. incision made in trauma bay to cross clamp the aorta) \n\n Currently enrolled in an ongoing, interventional, randomized clinical trial", + "brief_summary": "The purpose of this study was to compare the rate of surgical site infections in patients randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen.", + "NCTID": "NCT02255487", + "total_score": 0.13884935342569849, + "bm25_score": 0.05509460646762676, + "medcpt_score": 0.08375474695807175 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201421", + "patient": "<0.> A 21-year-old female is evaluated for progressive arthralgias and malaise. <1.> On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. <2.> Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. <3.> Her urine is positive for protein and RBC casts. <4.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT01520155", + "brief_title": "CArdiovascular Risk Assessment STudy in Lupus Erythemathodes (CASTLE)", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Systemic Lupus Erythematosus']", + "diseases_list": [ + "Systemic Lupus Erythematosus" + ], + "enrollment": "90.0", + "inclusion_criteria": "inclusion criteria: \n\n Patients with systemic Lupus erythematosus \n\n ", + "exclusion_criteria": ": \n\n Patients without systemic Lupus erythematosus", + "brief_summary": "The key of this prospective study is to identify a potentially increased cardiovascular risk in patients with systemic Lupus erythematodes, with and without renal affection. Three groups of patients will be compared.", + "NCTID": "NCT01520155", + "total_score": 0.2293077115223514, + "bm25_score": 0.12029984785937167, + "medcpt_score": 0.10900786366297974 + }, + { + "nct_id": "NCT00997100", + "brief_title": "Exploratory Study of Changes in Disease Activity and Biomarkers With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus (SLE)", + "phase": "Phase 2", + "drugs": "['paquinimod (ABR-215757)']", + "drugs_list": [ + "paquinimod (ABR-215757)" + ], + "diseases": "['Systemic Lupus Erythematosus']", + "diseases_list": [ + "Systemic Lupus Erythematosus" + ], + "enrollment": "13.0", + "inclusion_criteria": "inclusion criteria: \n\n Age > 18 years at the time of signing the informed consent form \n\n Fulfil at least 4 criteria for SLE as defined by the American College of Rheumatology (ACR) \n\n Present with active SLE disease with at least one of the following symptoms: \n\n i) Arthritis - > 2 joints with pain and signs of inflammation (i.e. tenderness, swelling, or effusion) ii) Inflammatory-type skin rash iii) Oral ulcers \n\n Laboratory values as follows \n\n Hemoglobin \u2265 100 g/L \n\n Absolute neutrophil count \u2265 1.0 x 109/L \n\n Total bilirubin \u2264 1.5 x upper limit of normal (ULN) \n\n AST (SGOT) / ALT (SGPT) \u2264 2.5 x ULN \n\n Ability to take and retain oral medication \n\n Ability to sign and date a written informed consent prior to entering the study \n\n Willingness and ability to comply with the protocol for the duration of the study \n\n ", + "exclusion_criteria": ": \n\n Active severe SLE flare with central nervous system (CNS) manifestations, active renal lupus, systemic vasculitis, active pericarditis, active pleuritis, active peritonitis or other SLE manifestations requiring treatment not allowed by the study protocol. \n\n Severe renal impairment (estimated or measured GFR <50%) \n\n Oral treatment with corticosteroids (>15 mg/day prednisolone or equivalent) or changes in corticosteroid dosing within 30 days prior to the first dose of study medication. This also includes intraarticular steroid injections or topical treatment for SLE symptoms. Inhaled or topical steroids may be given for reasons other than SLE disease activity (such as asthma, contact dermatitis) as clinically indicated. \n\n Intravenous corticosteroids within 3 months prior to the first dose of study medication. \n\n Intravenous cyclophosphamide within 6 months prior to the first dose of study medication. \n\n Treatment with anti-rheumatic/immunosuppressive drugs within 3 months prior to first dose of study medication, other than the following medications at stable doses: methotrexate (\u226425 mg/week), azathioprine (\u22642.5 mg/kg/day), hydroxychloroquine and mycophenolate mofetil (\u22643000 mg/day). \n\n B-cell depletion therapy (such as treatment with Rituximab) within 12 months prior to the first dose of study medication. \n\n Potent inhibitors or inducers of CYP3A4 intravenously or orally within 14 days prior to first dose of study medication. \n\n History of myocardial infarction or current uncontrolled angina, severe uncontrolled ventricular arrhythmias, symptomatic congestive heart failure, unstable angina pectoris, or electrocardiographic evidence of acute ischemia. \n\n Marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval >450 milliseconds \n\n History of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome) \n\n Treatment with concomitant medications that prolong the QT interval. \n\n History of, or current, ischemic CNS disease. \n\n Current malignancy. A 5-year cancer-free period is required with the exception of skin basal or squamous cell carcinoma or cervical cancer in situ that has been excised. \n\n Current severe infection \n\n Positive result on screening for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV) antibodies. \n\n Drug abuse. \n\n Major surgery within 3 weeks prior to study entry. \n\n Known or suspected hypersensitivity to ABR-215757 or excipients. \n\n Female subject of child-bearing potential who is not using a medically accepted safe method of contraception. All female subjects of child-bearing potential must have a negative urine pregnancy test at the Screening and Baseline Visits. As interaction studies between ABR-215757 and oral contraceptives have not yet been performed, women using the contraceptive pill must also use a complementary contraceptive device, i.e. barrier method, during the treatment period and for at least 1 month thereafter. \n\n Female subject of child-bearing potential who is pregnant or lactating. \n\n Simultaneous participation or participation within 4 months or 5 half lives (whichever is longer) prior to study entry in any other study involving investigational drugs or other experimental therapy. \n\n Other significant, unstable medical disease not related to SLE that in the investigator's opinion would confound the study result or put the patient at risk. \n\n Patients likely to receive oral or intravenous steroids or immunosuppressant for other non-SLE condition during the study duration, as this will confound the study result. \n\n Vaccination within 4 weeks prior to the first dose of study medication.", + "brief_summary": "This is an exploratory open label single arm study to evaluate changes in disease activity and biomarkers in patients with mild active SLE, during treatment with ABR-215757 given as add-on to standard therapy. To be eligible for the study SLE patients should present with symptoms from skin, mouth and/or joints. After a screening period of one week patients will be treated with ABR-215757 for 12 weeks. The initial dose of ABR-215757 will be 1.5 mg/day. There will be an option to increase the dose to 3.0 mg/day following 28 days of treatment. Follow-up visits will take place 4 weeks and 8 weeks after last day of treatment. Disease activity during treatment will be studied using the Systemic Lupus Erythematosus disease Activity Index (SLEDAI-2K) as well as organ system specific disease activity indexes (CLASI for skin involvement and number of swollen/tender joints using 28- and 66/68-joint counts). At specified time points during the study, blood samples and biopsies will be collected for analysis of established and exploratory biomarkers of SLE. Concomitant SLE treatment allowed include: prednisolone or equivalent at a dose of \u226415 mg/day, hydroxychloroquine, azathioprine, methotrexate and mycophenolate mofetil, all at stable doses from specified timepoints prior to the study and throughout the study.", + "NCTID": "NCT00997100", + "total_score": 0.20809568401604625, + "bm25_score": 0.07963206366741442, + "medcpt_score": 0.1284636203486318 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201422", + "patient": "<0.> A 15-year-old girl presents to the ER with abdominal pain. <1.> The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. <2.> She has had no appetite since yesterday but denies diarrhea. <3.> She has had no sexual partners and her menses are regular. <4.> On examination, she has localized rebound tenderness over the right lower quadrant. <5.> On an abdominal ultrasound, a markedly edematous appendix is seen. <6.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT00723788", + "brief_title": "Magnetic Resonance Imaging (MRI) of Appendicitis in Children", + "phase": "", + "drugs": "['MRI of the abdomen']", + "drugs_list": [ + "MRI of the abdomen" + ], + "diseases": "['Appendicitis']", + "diseases_list": [ + "Appendicitis" + ], + "enrollment": "21.0", + "inclusion_criteria": "inclusion criteria: \n\n Age 8-18 years, referred from emergency department for suspected appendicitis and receiving either CT scan or ultrasound of the abdomen for diagnosis \n\n ", + "exclusion_criteria": ": \n\n Failure to pass MRI metal screening. Claustrophobia or need for sedation due to inability to hold still.", + "brief_summary": "Study to find out if MRI can diagnose appendicitis in children as well as or better than CT scan and/or ultrasound scan performed at the same time. No additional contrast material or sedation will be used to perform the MRI.", + "NCTID": "NCT00723788", + "total_score": 0.14953081283469066, + "bm25_score": 0.06402777777777777, + "medcpt_score": 0.0855030350569129 + }, + { + "nct_id": "NCT00236912", + "brief_title": "A Study Comparing Safety and Efficacy of Levofloxacin and Metronidazole Versus Piperacillin/Tazobactam in Treating Complicated Appendicitis", + "phase": "Phase 4", + "drugs": "['levofloxacin; metronidazole']", + "drugs_list": [ + "levofloxacin; metronidazole" + ], + "diseases": "['Appendicitis']", + "diseases_list": [ + "Appendicitis" + ], + "enrollment": "139.0", + "inclusion_criteria": "inclusion criteria: \n\n Two or more symptoms of acute appendicitis for at least 24 hours or radiologic evidence of complicated appendicitis \n\n Able to take medicine orally after recovering from surgery \n\n If female, using birth control \n\n ", + "exclusion_criteria": ": \n\n History of allergy to any study medication \n\n Life expectancy < 72 hours \n\n APACHE II (health) score > 25 \n\n Neutropenic (low white blood cell count) \n\n HIV positive with current or past CD4 count < 200/mm^3 \n\n Low platelet count (bleeds easily) \n\n Malnourished with low albumin \n\n Condition requiring use of major tranquilizers", + "brief_summary": "The purpose of this study is to compare the efficacy and safety of two treatment regimens in treating patients with complicated appendicitis. Appendicitis requires antibiotic treatment when the appendix ruptures (complicated appendicitis). This is a study comparing intravenous (IV) antibiotic therapy of levofloxacin/metronidazole versus piperacillin/tazobactam for 4 to 14 days. Patients may be switched to oral therapy after 48 hours, at the doctor's discretion.", + "NCTID": "NCT00236912", + "total_score": 0.14740368587351343, + "bm25_score": 0.06271152618135377, + "medcpt_score": 0.0846921596921597 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201423", + "patient": "<0.> A 63-year-old man presents with cough and shortness of breath. <1.> His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. <2.> He also has a family history of early onset dementia. <3.> His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. <4.> He denies fever. <5.> On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. <6.> A chest x-ray is notable for hyperinflation with no consolidation. <7.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT02219360", + "brief_title": "Treatment in Patients Hospitalized With Acute Exacerbation of Chronic Obstructive Pulmonary Disease", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Chronic Obstructive Pulmonary Disease']", + "diseases_list": [ + "Chronic Obstructive Pulmonary Disease" + ], + "enrollment": "400.0", + "inclusion_criteria": "inclusion criteria: \n\n Hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease \n\n Age\u2265 40years old \n\n ", + "exclusion_criteria": ": \n\n The first diagnosis which caused hospitalization is not acute exacerbation of chronic obstructive pulmonary disease \n\n Chest radiography shows congestive heart failure \n\n Chest CT shows lung cancer, active pulmonary tuberculosis, pulmonary thromboembolism or interstitial lung diseases \n\n Serious cardiac failure, renal insufficiency or hepatic dysfunction", + "brief_summary": "Chronic obstructive pulmonary disease has become a serious global health care and public health problems due to its high prevalence, high morbidity and heavy economic burden. Acute exacerbation of chronic obstructive pulmonary disease is one of the most important causes of death in patients with COPD. Systemic corticosteroids therapy is recommended in COPD exacerbations. In clinical practice for the treatment of acute exacerbation of COPD\uff0c antibiotic application is still controversial. Evidence from current guideline is based on strict criteria from randomized controlled trials, thus the given condition is simplified. Patients meet the criteria account for the minority in the real world. Therefore, it is still not clear whether most patients benefit from the recommended treatment. In our design, hospitalized patients with acute exacerbation of COPD will be enrolled, with their treatment, arterial hypoxemia, recovery time and length of hospitalization being observed. The main purpose is to evaluate the benefit effect of current recommended treatment of acute exacerbation of COPD in the real world.", + "NCTID": "NCT02219360", + "total_score": 0.1942801031656795, + "bm25_score": 0.0956666506665224, + "medcpt_score": 0.09861345249915712 + }, + { + "nct_id": "NCT00170222", + "brief_title": "Placebo Versus Antibiotics in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)", + "phase": "Phase 4", + "drugs": "['doxycycline']", + "drugs_list": [ + "doxycycline" + ], + "diseases": "['Chronic Obstructive Pulmonary Disease']", + "diseases_list": [ + "Chronic Obstructive Pulmonary Disease" + ], + "enrollment": "258.0", + "inclusion_criteria": "inclusion criteria: \n\n Acute exacerbation of COPD type I or II according to GOLD \n\n Ability to perform lung function tests \n\n Ability to take oral medication \n\n ", + "exclusion_criteria": ": \n\n Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception. \n\n Pretreatment ( > 24 hours) with an antibiotic for the present exacerbation. \n\n Pretreatment with corticosteroids (>30 mg for more than 4 days) for the present exacerbation. \n\n Progression or new radiographic abnormalities on the chest X-ray. \n\n Severe exacerbation that required mechanical ventilation. \n\n History of bronchiectasis \n\n Recent or unresolved lung malignancy. \n\n Other disease likely to require antibiotic therapy. \n\n Significant gastrointestinal or other conditions that may affect study drug absorption. \n\n Class III or IV congestive heart failure or stroke. \n\n Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc. and the use of immunosuppressive drugs (>30 mg prednisolone maintenance dose or equivalent for more than 4 weeks). \n\n Cystic fibrosis \n\n Tuberculosis. \n\n Impaired renal function (creatinine clearance < 20 ml/min).", + "brief_summary": "The role of antibiotic therapy in patients with COPD remains controversial. While the outcome of several clinical trials is in favour of antibiotics, the quality of these studies in insufficient. In this study the efficacy of doxycycline is compared to placebo. All concommitant treatment (steroids, bronchodilator therapy, physiotherapy) is standardized.~The investigators hypothesize that patients with an acute exacerbations will have a better outcome when treated with antibiotics.", + "NCTID": "NCT00170222", + "total_score": 0.17570986731349184, + "bm25_score": 0.08697876544513511, + "medcpt_score": 0.08873110186835678 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201424", + "patient": "<0.> A 33-year-old male athlete presented to the ER with acute abdominal pain. <1.> Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. <2.> The patient's history is negative for smoking, drugs, and alcohol. <3.> BP: 60/30 mmHg, HR: 140/min. <4.> The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. <5.> Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture. <6.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT02229695", + "brief_title": "The Effect of Different Types of Temporary Abdominal Closure on Intra Abdominal Hypertension.", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Intra Abdominal Hypertension', 'Abdominal Compartment Syndrome']", + "diseases_list": [ + "Intra Abdominal Hypertension", + "Abdominal Compartment Syndrome" + ], + "enrollment": "42.0", + "inclusion_criteria": "inclusion criteria: \n\n Adults male or female over 18 year old undergoing emergency laparotomy. Patients that have their abdominal wall closed at the end of surgery by a temporary closure technique. \n\n ", + "exclusion_criteria": ": \n\n Patients that according to the surgeon estimates will not survive 24 hours.", + "brief_summary": "This is a prospective comparison trial. Patients that will be included in the trial are those that will have operations in which their abdominal closure is temporary, i.e. patients sustaining trauma or septic abdomen.~Patients will be grouped according to the method of temporarily abdominal closure (TAC) procedure:~Vacuum-assisted closure (VAC)~Bogota bag (BB), a sterile intravenous bag silo closure. The two methods are currently accepted with no clear cut evidence to prefer one on another. At Soroka Medical Center the decision to choose either of the methods is at the surgeon's discretion.~Intra-abdominal pressure will be measured in all patients by the urinary bladder pressure technique at 6 12 24 ant 48 hours post operation. The measurement is a routine procedure done as part of the monitoring processes of critically ill patients in the General Intensive Care Unit (GICU).~Patients will be evaluated for the development of acute intra abdominal hypertension with or without abdominal compartment syndrome.", + "NCTID": "NCT02229695", + "total_score": 0.13723351809582762, + "bm25_score": 0.05078323278552112, + "medcpt_score": 0.08645028531030652 + }, + { + "nct_id": "NCT01771861", + "brief_title": "Evaluation of Trauma Team Activation Criteria", + "phase": "", + "drugs": "['Trauma team activation']", + "drugs_list": [ + "Trauma team activation" + ], + "diseases": "['Trauma', 'Injuries']", + "diseases_list": [ + "Trauma", + "Injuries" + ], + "enrollment": "324.0", + "inclusion_criteria": "inclusion criteria: \n\n all patients admitted with the trauma team \n\n all patients admitted with Injury Severity Score >15 \n\n ", + "exclusion_criteria": ": \n\n secondary admittance(transfers)>24 post injury", + "brief_summary": "The aim of the study is to establish the predictive properties of our trauma team activation protocol, and its individual criteria, and if possible to suggest changes that reduce over- and undertriage.~The study will also give an overview of the frequency and type of emergency procedures at a university hospital trauma center, which can contribute to optimal resource use and indicate which type of surgical skills are necessary in our trauma emergency procedures.", + "NCTID": "NCT01771861", + "total_score": 0.0926762683834085, + "bm25_score": 0.04104865140769396, + "medcpt_score": 0.05162761697571456 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201425", + "patient": "<0.> An 8-year-old boy fell from his bike striking his left temple on the pavement. <1.> There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. <2.> Half an hour after the fall the child became drowsy, pale, and vomited. <3.> He was transferred to the emergency department. <4.> Upon arrival the heart rate was 52/min, blood pressure of 155/98. <5.> The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. <6.> The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment. <7.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT00282269", + "brief_title": "Hypothermia in Traumatic Brain Injury in Children (HiTBIC)", + "phase": "Phase 2; Phase 3", + "drugs": "['Induced Hypothermia']", + "drugs_list": [ + "Induced Hypothermia" + ], + "diseases": "['Traumatic Brain Injury']", + "diseases_list": [ + "Traumatic Brain Injury" + ], + "enrollment": "50.0", + "inclusion_criteria": "inclusion criteria: \n\n have a severe traumatic brain injury as defined by either a GCS \u2264 8 and an abnormal CT scan (intracranial hemorrhage, cerebral edema or diffuse axonal injury) or a motor score \u2264 3 and normal CT scan \n\n are aged between 1 and 16 years \n\n are mechanically ventilated \n\n ", + "exclusion_criteria": ": \n\n are not randomized by 6 hours after injury \n\n have penetrating brain injuries \n\n have fixed dilated pupils and GCS = 3 \n\n have proven cervical spinal cord injury \n\n have more than mild neurodevelopmental disability prior to injury \n\n have an acute isolated epidural hematoma and are expected to recover rapidly after surgical removal \n\n have had a post-traumatic seizure with a normal CT scan \n\n have refractory shock, defined as systolic blood pressure more than 2 standard deviations (SD) below the mean for age despite 80ml/kg intravenous fluid resuscitation", + "brief_summary": "The purpose of this study is:~To determine the safety and feasibility of performing an international multi-centre randomized control trial of early and prolonged hypothermia to improve outcome in children with severe traumatic brain injury (TBI).~To determine whether in children with severe traumatic brain injury, prolonged initial hypothermia (minimum 72 hours at 32-33 degrees) improves the proportion of good outcomes 12 months after injury when compared to initial normothermia (36-37 degrees).", + "NCTID": "NCT00282269", + "total_score": 0.24187937726332398, + "bm25_score": 0.11316824712362236, + "medcpt_score": 0.12871113013970156 + }, + { + "nct_id": "NCT02378311", + "brief_title": "Handlebar Grip Related Injury Prevention (GRIP) Study: Are Exposed Metal Handlebar Ends a Risk Factor for Injury?", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Injuries', 'Trauma', 'Wounds and Injuries', 'Children', 'Child']", + "diseases_list": [ + "Injuries", + "Trauma", + "Wounds and Injuries", + "Children", + "Child" + ], + "enrollment": "50.0", + "inclusion_criteria": "inclusion criteria: \n\n Children 0-15 years inclusive \n\n Presenting to either of the study hospitals for assessment or treatment \n\n Sustained an injury or suspected to have sustained an injury (i.e. AIS >=0) \n\n Due to an incident involving any non-motorized bicycle, tricycle or kick scooter \n\n ", + "exclusion_criteria": ": \n\n Incidents where the injured child was involved in a motor vehicle collision \n\n Incidents where the injured child was injured by another rider (e.g. injured child run over by a cyclist) \n\n Incidents involving a bicycle fitted with 'bull bars' \n\n Patients for whom neither parent / guardian is fluent in English (if the history is clear from a parent, the patient will be eligible for inclusion) \n\n If an eligible patient is dead on arrival the family will not be invited to participate, and they will not subsequently be contacted \n\n If an eligible patient dies during their admission, they will be withdrawn from further involvement in the study and the family will not be contacted", + "brief_summary": "Cycling injuries are the 3rd most common mechanism of injury in 7-13 year olds[1]. Bicycle injuries have remained one of the commonest causes of paediatric abdominal trauma for over 60 years[2,3]. 15% of child cyclist injuries involve impact with a handlebar; two-thirds of those are abdominal injuries[4]. Handlebar impact is now the commonest mechanism of major paediatric abdominal injury[3]. Serious handlebar injuries often occur after apparently minor falls; they are not unique to riders performing stunts[5].~One small study found that the metal handlebar ends were often exposed on bikes of children sustaining severe abdominal injuries[6]. Most European safety standards do not test grip durability[7-10]. Day-to-day use can damage rubber grips, exposing the underlying metal handlebar tube.~This feasibility study aims to test the research methods that will be used in a subsequent nationwide multicentre study. The main study will investigate the association between injuries and handlebar grip condition.~Children attending study hospitals with any bicycle or kick scooter injury will be invited to participate. Parents of injured children will be invited to complete questionnaires regarding circumstances surrounding the injury and condition of the handlebar ends on the bike or scooter involved. Clinical information regarding the injury will also be collected. The handlebar end condition will be compared between children sustaining a handlebar end injury [Cases] and riders whose injury did not involve the handlebar [Controls].~If exposed handlebar ends are more prevalent amongst riders with handlebar end injuries, injury prevention strategies can focus on methods to prevent damage occurring to grips through day-to-day use. If no such association is found, prevention strategies can be focused elsewhere, such as on design of effective protective clothing.~Data collection for this feasibility study will occur between March 2015 and September 2015.~The Chief Investigator, Mr. Andrew Neilson, funds the feasibility study.", + "NCTID": "NCT02378311", + "total_score": 0.12209198879859422, + "bm25_score": 0.06086651077468431, + "medcpt_score": 0.06122547802390992 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201427", + "patient": "<0.> A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. <1.> His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. <2.> Both siblings are currently well without any findings of neoplasms. <3.> The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. <4.> Several of these are biopsied and are all benign adenomas. <5.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT01187901", + "brief_title": "A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients", + "phase": "Phase 2", + "drugs": "['Erlotinib', 'Sulindac', 'Placebo A', 'Placebo B']", + "drugs_list": [ + "Erlotinib", + "Sulindac", + "Placebo A", + "Placebo B" + ], + "diseases": "['Adenomatous Polyposis Coli']", + "diseases_list": [ + "Adenomatous Polyposis Coli" + ], + "enrollment": "92.0", + "inclusion_criteria": "inclusion criteria: \n\n Patients who are 18 years or older with a clinical or genetic diagnosis of FAP or attenuated FAP. \n\n Presence of duodenal polyps with a sum of diameters \u2265 5mm. \n\n Minimum of two weeks since any major surgery \n\n WHO performance status \u22641 \n\n Adequate bone marrow function as show by: normal leukocyte count, platelet count \u2265 120 x 109/L, Hgb > 12 g/dL \n\n Adequate liver function as shown by: normal serum bilirubin(\u2264 1.5 Upper Limit Normal {ULN}) and serum transaminases (\u2264 2.0 ULN) \n\n Patient must discontinue taking any Nonsteroidal anti-inflammatory drugs (NSAIDS) within one month of treatment initiation. \n\n Patients must be able to provide written informed consent. \n\n ", + "exclusion_criteria": ": \n\n Prior treatment with any investigational drug within the preceding 4 weeks. \n\n Malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skins. \n\n Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study as determined by the Principal Investigator such as: \n\n Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction \u2264 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia \n\n Severely impaired lung function \n\n Any active (acute or chronic) or uncontrolled infection/ disorders. \n\n Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy \n\n Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis \n\n Screening clinical laboratory values that indicate any of the following: \n\n anemia \n\n thrombocytopenia \n\n leucopenia \n\n elevations of transaminases greater than 2X ULN \n\n elevation of bilirubin > 1.5 X ULN \n\n alkaline phosphatase elevation > 1.5 X ULN \n\n increased creatinine, urinary protein, or urinary casts outside the clinically normal range. \n\n Gastrointestinal bleeding (symptoms including dyspnea, fatigue, angina, weakness, malaise, melena, hematochezia, hematemesis, anemia or abdominal pain will require clinical assessment to rule out gastrointestinal bleeding). \n\n Patient who is currently taking any anti-coagulation medication. \n\n Women who are pregnant or breast feeding. \n\n Patients with a known hypersensitivity to sulindac or erlotinib or to their excipients", + "brief_summary": "The purpose of this study is to determine in a randomized, placebo-controlled, phase II trial if the combination of sulindac and erlotinib causes a significant regression of duodenal and colorectal adenomas in familial adenomatous polyposis (FAP) and attenuated FAP (AFAP) patients.", + "NCTID": "NCT01187901", + "total_score": 0.1992857142857143, + "bm25_score": 0.09928571428571427, + "medcpt_score": 0.09999999999999999 + }, + { + "nct_id": "NCT01713881", + "brief_title": "Effect of a Tracking Program on Colon Adenoma Surveillance and Adherence to Guideline Recommendations", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Colon Polyp Surveillance']", + "diseases_list": [ + "Colon Polyp Surveillance" + ], + "enrollment": "500.0", + "inclusion_criteria": "inclusion criteria: \n\n Any adenoma found on screening/surveillance colonoscopy (ICD9-211.3, Procedure code 45385 or 45380) \n\n Greater than 18 years old \n\n ", + "exclusion_criteria": ": \n\n Less than 18 years old \n\n Diagnosis of IBD", + "brief_summary": "This will be a retrospective chart review of 880-1000 patients who had a colonoscopy and were found to have a tubular adenoma between the years of 2004-2008. We will compare the rate and timing of completion of repeat colonoscopies pre and post establishment of a polyp registry (tracking system) in 2006. Each group will be composed of up to 500 subjects consecutively identified from all the patients who underwent colonoscopy and were found to have a tubular adenoma (Group 1-2004 to 2006, Group 2 2007-2008).", + "NCTID": "NCT01713881", + "total_score": 0.12656481416862464, + "bm25_score": 0.023191798295608752, + "medcpt_score": 0.10337301587301588 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201429", + "patient": "<0.> A 51-year-old woman is seen in clinic for advice on osteoporosis. <1.> She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. <2.> She currently smokes 1 pack of cigarettes per day. <3.> She was documented by previous LH and FSH levels to be in menopause within the last year. <4.> She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention. <5.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT00703417", + "brief_title": "Does Bone Structure Explain the Increased Fracture Risk in Type II Diabetes Patients? A Pilot Study", + "phase": "", + "drugs": "['magnetic Resonance Imaging', 'Computed Tomography', 'High resolution peripheral quantitative computed tomography']", + "drugs_list": [ + "magnetic Resonance Imaging", + "Computed Tomography", + "High resolution peripheral quantitative computed tomography" + ], + "diseases": "['Osteoporosis']", + "diseases_list": [ + "Osteoporosis" + ], + "enrollment": "40.0", + "inclusion_criteria": "inclusion criteria: \n\n Postmenopausal female, 55-75 years old \n\n History of Type II diabetes, as defined by the American Diabetes Association for more than 5 years that is either insulin requiring or treated with oral therapies such as sulfonylureas and metformin \n\n Body mass index (BMI) of 19-35 \n\n Able to move without walkers and without a history of long periods (>3 months) of inactivity \n\n Additional inclusion criteria for fracture participants: \n\n Fractures of the proximal humerus and femur as well as the ankle and foot should have occurred after the onset of diabetes and should have been caused by a low energy trauma such as falling from standing height. All fractures will be verified by radiographs. \n\n ", + "exclusion_criteria": ": \n\n Severe neuropathic disease such as neurogenic osteoarthropathies (i.e., Charcot joints) of the foot \n\n Steroid users or have disease conditions that could play a significant role in the development of osteoporosis such as idiopathic osteoporosis, immobilization, hyperparathyroidism, or hyperthyroidism \n\n Diseases that may affect bone metabolism: alcoholism, chronic drug use, chronic gastrointestinal disease, renal or hepatic impairment \n\n Chronic treatment with antacids, estrogen, adrenal or anabolic steroids, anticonvulsants, anticoagulants, or pharmacologic doses of Vitamin A supplements 6 months prior \n\n Diabetic patients on rosiglitazone or pioglitazone medications \n\n high energy trauma, e.g., due to motor vehicle accidents \n\n Pathological fractures of other origin, i.e., tumor, tumor-like lesions as well as focal demineralization visualized on radiographs \n\n History of fluoride, bisphosphonate, calcitonin or tamoxifen use \n\n History of unstable cardiovascular disease or uncontrolled hypertension \n\n MRI contraindications \n\n Body mass index greater than 35", + "brief_summary": "For this cross-sectional case control pilot study 30 women, 55-75 years old with type II diabetes will be recruited. Diabetes will be defined as self-report of diabetes previously diagnosed by a physician, use of hypoglycemic medications, or fasting glucose > 126 mg/dl (7.0mM) in accordance with the American Diabetes Association criteria. The diabetic patient population will be divided into 2 groups: patients with status post low energy fractures of the proximal humerus, the proximal femur, the ankle and the foot (n=10) versus diabetic patients with no fractures or low energy trauma fracture history (n=10). An additional group of 10 diabetic postmenopausal women will be recruited and will have magnetic resonance imaging (MRI) of the lower back only. Caucasian, Asian and Hispanic women will be combined since a previous study suggested that BMD is very similar in these 3 population and that ethnic differences are minimal. In addition a population of 10 age-matched, BMI-matched, race-matched healthy women, without osteoporotic fractures will be examined. In all of these volunteers a medical history will be obtained to ensure good health status and rule out chronic diseases that would have an impact on bone metabolism. Patients will undergo MRI, QCT and high-resolution peripheral quantitative computed tomography (HR-pQCT) examinations to determine bone mineral density and bone structure/quality.~The hypothesis of this pilot project is that type II diabetic patients with and without low-energy fractures have a different trabecular bone architecture and composition, which is also different when compared to normal age-matched healthy patients. Architectural differences in these three patient groups may be visualized with high resolution MRI and high-resolution peripheral quantitative computed tomography (HR-pQCT) and will be most pronounced at the calcaneus and the distal tibia. Analyzing structure parameters obtained from high resolution MRI and spectroscopy may improve our understanding of the pathophysiology of diabetic bone disease and the prediction of fracture risk in an elderly diabetic population.", + "NCTID": "NCT00703417", + "total_score": 0.16478862783277062, + "bm25_score": 0.0859723823498585, + "medcpt_score": 0.07881624548291215 + }, + { + "nct_id": "NCT01978834", + "brief_title": "Age Dependend Diagnostic Thresholds for Osteoporosis Bindex Ultrasonometer", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Osteoporosis']", + "diseases_list": [ + "Osteoporosis" + ], + "enrollment": "560.0", + "inclusion_criteria": "inclusion criteria: \n\n Female sex \n\n Age 50 to 89 years \n\n ", + "exclusion_criteria": ": \n\n Those who have opted out of being contacted for research on their general Park Nicollet clinic consent will not be recruited by mail \n\n Inability to sign consent form due to cognitive impairment. Those with dementia (ICD-9 diagnosis codes 331.0, 294.1, 294.10, 294.11, or 294.8) will excluded from mailed recruitment \n\n Measurement of hip BMD is not feasible (for example, those who have had bilateral hip replacement surgeries or who cannot have central DXA because of their body weight) \n\n Open leg or arm wounds at sites where ultrasound measurements are supposed to be taken, precluding such measurements", + "brief_summary": "This study is designed for clinical validation of the novel ultrasound device (Bindex\u00ae, Bone Index Finland Ltd.). In a preliminary study technique has been validated in Finnish elderly woman population with 285 healthy and 56 osteoporotic subjects (n = 341 in total). Significant and good correlation was observed between Density Index (DI) determined with Bindex and femoral bone mineral density determined with DXA (r = 0.65 - 0.70). In addition, with determination of 90% sensitivity and specificity thresholds, significant number (65-75%) of patients could be diagnosed without additional verification with DXA.~First, the thresholds for DI will be determined by measuring 70 osteoporotic and 70 healthy patients (n = 140) with Bindex and DXA within four decades of age; age 50 to 59 years, age 60 to 69 years, age 70 to 79 years, and age 80 to 89 years. The feasibility of DI for diagnostics of osteoporosis and evaluation of bone mineral density (BMD) will be assessed. The thresholds for the BMD estimate obtained with DI will be determined for osteoporotic and non-osteoporotic patients. For fracture risk assessment, DI measurements are used to predict the outcome of currently available fracture risk assessment tools.~To investigate optimal configuration of ultrasound parameters and patient characteristics for prediction of proximal femur and lumbar spine BMD for women in each four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.~To develop national diagnostic thresholds for DI in prediction of osteoporosis status with a reference female population (American-Caucasian) in each four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.", + "NCTID": "NCT01978834", + "total_score": 0.14502826492916007, + "bm25_score": 0.07337962962962963, + "medcpt_score": 0.07164863529953044 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201430", + "patient": "<0.> A 72-year-old man complains of increasing calf pain when walking uphill. <1.> The symptoms have gradually increased over the past 3 months. <2.> The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. <3.> Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. <4.> His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. <5.> On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. <6.> There is a right carotid bruit. <7.> His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. <8.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT00721006", + "brief_title": "Phase II Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia", + "phase": "Phase 2", + "drugs": "['MESENDO', 'Placebo']", + "drugs_list": [ + "MESENDO", + "Placebo" + ], + "diseases": "['Critical Limb Ischemia', 'Severe Leg Ischemia', 'Peripheral Artery Disease', 'Peripheral Vascular Disease']", + "diseases_list": [ + "Critical Limb Ischemia", + "Severe Leg Ischemia", + "Peripheral Artery Disease", + "Peripheral Vascular Disease" + ], + "enrollment": "35.0", + "inclusion_criteria": "inclusion criteria: \n\n Males or females older than 18 years of age. \n\n Limb ischemia with ABI of < 0.7 in the index lower extremity in two consecutive examinations done at least 1 week apart. \n\n Limb ischemia with resting ischemic pain and/or claudication at 100 meters and/or non-healing ulcers. \n\n Claudication \n\n Patients not considered candidates for surgical or percutaneous revascularization, due to poor target vessels, inability to cross total occlusions, or a morbidity which precludes general anesthesia. \n\n ", + "exclusion_criteria": ": \n\n Inability to provide informed consent. \n\n Previous angiogenic therapy. \n\n Known sensitivity to gentamycin and/or amphotericin B. \n\n Use or expected use of antineoplastic drugs. \n\n Any illness, which might affect the patient's survival after enrollment in the protocol. \n\n Any illness or significant laboratory abnormality, which in the investigator's judgment will interfere with the patient's ability to comply with the protocol, compromise the patient's safety, or interfere with the interpretation of the study results. \n\n No evidence of acute infection \n\n WBC > 15000. \n\n WBC < 4000. \n\n Serum Creatinine > 3.0 mg/dL in patients who are not in hemodialysis. \n\n Pregnant women or women planning to become pregnant or unwilling to use appropriate birth control methods before and 2 months after cell infusion. \n\n Recent myocardial infarction within 3 months prior to screening.", + "brief_summary": "The purpose of this research study is to compare in patients with double-sided claudication if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in one of the severly diseased ischemic limbs(legs)versus the control limb that receives a placebo product.~Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decrease blood flow to the extremities (mainly feet and legs) and has progressed to the point of severe pain and even skin ulcers or sores.~LI needs comprehensive treatment since the condition will not improve on its own. The overall goal of treatment is to reduce pain and increase blood flow to improve symptoms or save the leg and feet. In many cases, current options for treatment including medications, surgery or endovascular procedures have not been successful.~In the last few years, investigators have explored therapies aimed to increase blood flow to the ischemic vessel by transplanting cells that will promote the development of new vessels in the diseased leg.~The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriated blood supply to the leg.~Patients eligible to participate in the this study are those suffering from double-sided claudication with poor circulation or severe leg blockages, which are not candidates for surgical procedures.~Once the mixture of stem cells is prepared and the patient's bone marrow is ready, cells will be transplanted into the calf muscle of one the the diseased legs while the other diseased leg will receive the placebo. Clinical study to evaluate and compare the efficacy of the stem cell transplant will be performed for six months post cell transplant.", + "NCTID": "NCT00721006", + "total_score": 0.189473072387681, + "bm25_score": 0.09463937710014814, + "medcpt_score": 0.09483369528753288 + }, + { + "nct_id": "NCT02273232", + "brief_title": "Effects of Remote Ischemic Preconditioning on Moderate PVD Patients A Pilot Randomized Control Trial", + "phase": "Phase 1", + "drugs": "['Remote Ischemic Preconditioning', 'Supervised Exercise', 'Standard Care']", + "drugs_list": [ + "Remote Ischemic Preconditioning", + "Supervised Exercise", + "Standard Care" + ], + "diseases": "['Peripheral Arterial Diseases']", + "diseases_list": [ + "Peripheral Arterial Diseases" + ], + "enrollment": "40.0", + "inclusion_criteria": "inclusion criteria: \n\n Known moderate PVD \n\n New claudication patient with Rutherford stage 2 and Fontaine stage 2a symptoms \n\n ", + "exclusion_criteria": ": \n\n Known upper limb PVD \n\n Severe cardiac condition \n\n Risk classification for exercise training: class C and above \n\n Severe respiratory condition \n\n Previous history of upper limb deep vein thrombosis \n\n Patients on glibenclamide or nicorandil- May affect RIPC \n\n Raynaud's Disease \n\n Contra indications for MRA \n\n Pregnancy \n\n Previous major limb amputation affect ability to exercise", + "brief_summary": "Remote ischemic Preconditioning (RIPC) is a phenomena first observed in cardio-thoracic patients in which exposing the limbs for periods of short intermittent ischemia produces protective effect on heart muscle. The concept was applied to many other parts of the body and the results are positive so far.~No human trials on this concept has been conducted in patients with peripheral vascular disease so far but applying the concept for healthy individuals shows vessels dilatation and animal trials shows degree of new vessels formation in addition to reports of symptoms improvement.~The trial candidates will be allocated blindly in 4 groups. All groups will have advice about exercise which is the standard practice now. The first group will have supervised exercise. The second group will in addition to the supervised exercise get the ischemic preconditioning with the blood pressure cuff. The third group will get the ischemic preconditioning and the fourth group will get the standard exercise advice. All candidates will have Magnetic Resonance Image Scan (MRA) for their blood vessels in the beginning of the trial and again at the end.~The effect of the RIPC (Remote ischemic Preconditioning) and exercises on patient symptoms, new vessel formation and other parameters will be recorded", + "NCTID": "NCT02273232", + "total_score": 0.18323620871498716, + "bm25_score": 0.07585046126712791, + "medcpt_score": 0.10738574744785925 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-20151", + "patient": "<0.> A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. <1.> His heart rate is 135 bpm and blood pressure is 70/40 mmHg. <2.> Physical exam findings include decreased mental status and cool extremities. <3.> He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. <4.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT01142245", + "brief_title": "Effect of IV and Oral Esomeprazole in Prevention of Recurrent Bleeding From Peptic Ulcers After Endoscopic Therapy", + "phase": "Phase 3", + "drugs": "['Oral esomeprazole', 'Intravenous Esomeprazole']", + "drugs_list": [ + "Oral esomeprazole", + "Intravenous Esomeprazole" + ], + "diseases": "['Bleeding', 'Peptic Ulcer']", + "diseases_list": [ + "Bleeding", + "Peptic Ulcer" + ], + "enrollment": "263.0", + "inclusion_criteria": "inclusion criteria: \n\n Age \u2265 18 \n\n Confirmed ulcer bleeding with Forrest Ia, Ib, IIa, IIb \n\n Endoscopic hemostasis achieved \n\n Informed consent obtained \n\n ", + "exclusion_criteria": ": \n\n No consent \n\n Forrest II c, III (clear ulcer base/flat spot and no active bleeding, i.e., minimal risk for rebleeding) \n\n Unsuccessful endoscopic treatment (i.e., injection and/or thermal coagulation for the initial bleeding) or severe bleeding that immediate surgery is indicated \n\n Moribund patients in whom active treatment of any form is not considered. \n\n Polytrauma, severe injury, unconsciousness, burns, or need for continuous artificial ventilation \n\n Upper GI malignancy or disseminated malignant disease \n\n Esophageal varices \n\n A Mallory-Weiss lesion \n\n Phenytoin or theophylline treatment \n\n Uses of PPI or H2RAs within 3 days of admission, including uses at Emergency Department N.B. Usage of aspirin or NSAID is not an ", + "brief_summary": "The investigators previously showed that the use of a high-dose intravenous PPI regimen after endoscopic control of bleeding from peptic ulcers reduced rate of recurrent bleeding, decreased the need for endoscopic and surgical interventions and in general improved patients' outcomes. A trend towards reduced mortality associated with the use of high-dose intravenous PPI was also observed. Recent clinical trials from Asia have provided evidence that high-dose oral PPIs are associated with a reduction in rebleeding. Current meta-analysis suggests that both high dose (intravenous) and low dose (oral) PPIs effectively reduce rebleeding vs placebo. However, there has been no clinical study to compare IV infusion to oral PPI in this patient population.~The purpose of this clinical study is to compare the efficacy and safety of intravenous and oral Esomeprazole in patients with peptic ulcer hemorrhage who are at risk for recurrent bleeding. The investigators hypothesize that using IV infusion is superior to oral PPI.", + "NCTID": "NCT01142245", + "total_score": 0.17390822784721488, + "bm25_score": 0.09699087024087025, + "medcpt_score": 0.07691735760634463 + }, + { + "nct_id": "NCT00843063", + "brief_title": "Famotidine Compared With Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion", + "phase": "Phase 4", + "drugs": "['pantoprazole vs famotidine']", + "drugs_list": [ + "pantoprazole vs famotidine" + ], + "diseases": "['Peptic Ulcer/Erosions']", + "diseases_list": [ + "Peptic Ulcer/Erosions" + ], + "enrollment": "161.0", + "inclusion_criteria": "inclusion criteria: \n\n upper GIB or dyspepsia due to peptic ulcers / erosions while receiving low-dose aspirin with a daily dose ranging from 80 mg to 320 mg \n\n endoscopy revealed a gastric or duodenal ulcers of 3 mm or more in diameter with unequivocal depth, or more than 5 erosions in the stomach or duodenum \n\n they required continuous low-dose aspirin for the secondary prevention of coronary heart disease, peripheral vascular disease and ischemic stroke or transient ischemic attacks \n\n 18 years old or older. \n\n ", + "exclusion_criteria": ": \n\n concurrent erosive or ulcerative esophagitis \n\n pyloric stenosis \n\n previous gastric or duodenal surgery other than oversewing of a perforation \n\n thrombocytopenia \n\n renal failure with estimated creatinine clearance less than 10 ml / min \n\n active cancer \n\n known allergic to aspirin, famotidine or pantoprazole \n\n pregnancy, lactation, child-bearing potential in the absence of contraception \n\n psychosomatic disorder \n\n planned co-prescription of nonsteriodal anti-inflammatory drugs corticosteriod, or anticoagulant \n\n disorders that might modify the absorption of study drugs", + "brief_summary": "Low-dose aspirin can prevent cerebral and cardiovascular accidents in individuals with symptomatic atherothrombotic disease, but its use is frequently limited by gastrointestinal side effects.~The position of H2-receptor antagonists as a step-down therapy after healing of peptic ulcer or erosions by proton pump inhibitor is unclear.~The objective of this randomized, double blinded control study was to compare the efficacy of high-dose famotidine with pantoprazole in the prevention of recurrent dyspeptic or complicated ulcer/ erosions in patients taking low-dose aspirin", + "NCTID": "NCT00843063", + "total_score": 0.12718593302961648, + "bm25_score": 0.060291126366641246, + "medcpt_score": 0.06689480666297526 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-20152", + "patient": "<0.> A 62 yo male presents with four days of non-productive cough and one day of fever. <1.> He is on immunosuppressive medications, including prednisone. <2.> He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). <3.> BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells. <4.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT02532452", + "brief_title": "Third Party Viral Specific T-cells (VSTs)", + "phase": "Phase 2", + "drugs": "['Viral Specific VST Infusion']", + "drugs_list": [ + "Viral Specific VST Infusion" + ], + "diseases": "['Viral Infection', 'Viral Reactivation', 'Infection in an Immunocompromised Host']", + "diseases_list": [ + "Viral Infection", + "Viral Reactivation", + "Infection in an Immunocompromised Host" + ], + "enrollment": "450.0", + "inclusion_criteria": "inclusion criteria: \n\n Immunocompromised patient with evidence of viral infection or reactivation \n\n Age >1 day \n\n Recipients who have had a stem cell transplant must be at least 21 days after stem cell infusion \n\n Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other steroid equivalent \n\n Must be able to receive CTL infusion in Cincinnati \n\n Informed consent obtained by PI or sub-investigator either in person or by phone \n\n ", + "exclusion_criteria": ": \n\n Active acute GVHD grades II-IV \n\n Uncontrolled bacterial or fungal infection \n\n Uncontrolled relapse of malignancy \n\n Infusion of ATG or alemtuzumab within 2 weeks of VST infusion", + "brief_summary": "The purpose of this study is to demonstrate that viral specific T-cells (a type of white blood cell) can be generated from an unrelated donor and given safely to patients with viral infections.", + "NCTID": "NCT02532452", + "total_score": 0.15449678116860782, + "bm25_score": 0.06181704260651629, + "medcpt_score": 0.0926797385620915 + }, + { + "nct_id": "NCT00034437", + "brief_title": "Immune Response to Cytomegalovirus", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Cytomegalovirus Infections']", + "diseases_list": [ + "Cytomegalovirus Infections" + ], + "enrollment": "20.0", + "inclusion_criteria": "inclusion criteria: \n\n Age 18-65 \n\n CMV seropositive \n\n Informed consent given \n\n ", + "exclusion_criteria": ": \n\n CMV seronegative \n\n Abnormal blood counts (hemoglobin less than 12 g/dl, platelets less than 150,000/ul, absolute neutrophil count less than 1,500/ul, absolute lymphocyte count less than 1,000/ul) \n\n Known history of heart, lung, kidney, liver, or bleeding disorder \n\n Diagnosis of HIV infection \n\n Diagnosis or suspicion of immunodeficiency state \n\n History of intravenous drug use \n\n Currently pregnant", + "brief_summary": "This study will evaluate immune responses against cytomegalovirus (CMV). About 80 percent of adults have been exposed to this virus. CMV typically remains dormant (inactive) in the body, causing no problems. In people with immune suppression, however, the virus can become reactivated and cause life-threatening pneumonia. The knowledge gained from this study may be useful in developing ways to improve immune responses to CMV in stem cell transplant recipients.~Healthy normal volunteers between 18 and 65 years of age who have been exposed to cytomegalovirus are eligible for this study. Candidates will be screened with a medical history and blood tests. Those enrolled will provide a 30-milliliter (6-tablespoon) blood sample once a week for 4 weeks and a final sample 2 months later. The blood will be used to design a test to detect immune responses against CMV and determine the differences in these responses among healthy individuals.", + "NCTID": "NCT00034437", + "total_score": 0.14547441787847099, + "bm25_score": 0.05678102385419459, + "medcpt_score": 0.08869339402427637 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-20153", + "patient": "<0.> A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. <1.> Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. <2.> Relevant physical exam findings include a respiratory rate of 35 and right calf pain. <3.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT01326507", + "brief_title": "Prognostic Value of Heart-type Fatty Acid-Binding Protein (h-FABP) in Acute Pulmonary Embolism", + "phase": "", + "drugs": "[\"Dosage de l'h-FABP\"]", + "drugs_list": [ + "Dosage de l'h-FABP" + ], + "diseases": "['Pulmonary Embolism']", + "diseases_list": [ + "Pulmonary Embolism" + ], + "enrollment": "165.0", + "inclusion_criteria": "inclusion criteria: \n\n patients with acute pulmonary embolism diagnosed in the emergency departement \n\n ", + "exclusion_criteria": ": \n\n patient under guardianship \n\n patient without social insurance \n\n pregnant women \n\n refusal to sign the consent \n\n myocardial infarction in the 10 days before pulmonary embolism", + "brief_summary": "The patients presenting with acute pulmonary embolism and right ventricular dysfunction are at high risk for life-threatening events and must be identified in the emergency department for adequate care and hospital admission. Echocardiography can identify right ventricular dysfunction, but this test is not always available, and echocardiographic criteria of right ventricular dysfunction vary among published studies. The primary purpose of this protocol is to study the prognostic value of a cardiac biomarker, h-FABP (heart-type Fatty Acid-Binding Protein) , to identify in the emergency department the patients presenting with high risk pulmonary embolism. As secondary outcomes, H-FABP results will be compared to other cardiac biomarkers (BNP, troponin) and clinical score performances that have been previously studied to stratify the prognosis of patients with pulmonary embolism in the emergency department.", + "NCTID": "NCT01326507", + "total_score": 0.15029783288222626, + "bm25_score": 0.07130705380086745, + "medcpt_score": 0.07899077908135879 + }, + { + "nct_id": "NCT01139632", + "brief_title": "The Contribution of Lp-PLA2 Level to the Presence of Coronary Plaques in Patients With Non Alcoholic Fatty Liver Disease", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Nonalcoholic Fatty Liver Disease', 'Coronary Artery Disease']", + "diseases_list": [ + "Nonalcoholic Fatty Liver Disease", + "Coronary Artery Disease" + ], + "enrollment": "60.0", + "inclusion_criteria": "inclusion criteria: \n\n Patients at intermediate risk for significant CAD was admitted to the hospital with the diagnosis of chest pain or undergoing elective CT coronarography due to suspection of coronary artery disease. \n\n Male and female 18years or older. \n\n Able to provide written informed consent. \n\n Intermediate Risk patients for having significant CAD is de\ufb01ned as: \n\n chest pain or dyspnea in the presence of negative stress tests; \n\n the absence of chest pain but positive stress tests; \n\n the absence of chest pain and of positive stress tests but intermittent arrhythmias \n\n ", + "exclusion_criteria": ": \n\n Acute coronary syndrome presentation: \n\n ST segment deviation on ECG and/or \n\n Cardiac troponin elevation. \n\n Chest pain in combination with positive tests for myocardial ischemia \n\n Hemodynamic instability on presentation. \n\n Inability to write inform consent. \n\n Age <18 years. \n\n Participation in an investigational study within the previous 30days.", + "brief_summary": "The most common cause of death in patients with NAFLD(Nonalcoholic Fatty Liver Disease) is CAD(Coronary Artery Disease). NAFLD patients have 65% more mortality than general population. The aim of the investigators study is to diagnose early coronary artery disease in NAFLD patient by measuring of PLA2. The investigators expect that PLA2 will higher in patients with patients with combination of CAD, unstable plaque and NAFLD.", + "NCTID": "NCT01139632", + "total_score": 0.08290416728421351, + "bm25_score": 0.03777679958470377, + "medcpt_score": 0.045127367699509764 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-20154", + "patient": "<0.> An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. <1.> The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. <2.> Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. <3.> The heart sounds were rapid and with no murmurs. <4.> CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. <5.> An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. <6.> A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. <7.> Coronary angiography showed no stenosis or clinically significant disease. <8.> Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. <9.> A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. <10.> The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation. <11.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT00844987", + "brief_title": "Vascular Endothelial Growth Factor (VEGF), Platelet Derived Growth Factor (PDGF), Hepatocyte Growth Factor (HGF) in Patients With Acute Coronary Syndrome (ACS)", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Acute Coronary Syndrome']", + "diseases_list": [ + "Acute Coronary Syndrome" + ], + "enrollment": "120.0", + "inclusion_criteria": "inclusion criteria: \n\n typical chest pain; \n\n ST segment elevation or depression in ECG; \n\n indication for coronary angiography; if necessary with PCI and 4) signed inform consent. \n\n ", + "exclusion_criteria": ": \n\n known past history of a myocardial infarction; \n\n not signed informed consent.", + "brief_summary": "The main aim of the study is a comparison of serum and plasma concentration of VEGF (Vascular Endothelial Growth Factor), HGF (Hepatocyte Growth Factor) and PDGF (Platelet Derived Growth Factor) with markers of myocardial injury as troponin I, hsCRP, CK-MB and NT-proBNP assessed in patients with first episode of acute coronary syndrome (ACS) in their lives and the estimation of assumed value of VEGF, HGF and PDGF in prognosis of cardiovascular complications at 3 months follow up especially with respect to myocardial infarction (MI), exacerbation of angina, reintervention (PTCA,CABG), symptoms of heart failure, stroke, rehospitalization due to cardiovascular reasons and death. The dynamics of changes in serum and plasma concentration of growth factors in comparison with values of myocardial injury markers will be checked. For the realization of the purpose of the study biochemical measurements will be performed twice i.e. just after admission to hospital and 24h later. Area of a myocardial injury will be estimated by echocardiography examination.", + "NCTID": "NCT00844987", + "total_score": 0.18072755978853955, + "bm25_score": 0.09583946817366276, + "medcpt_score": 0.08488809161487684 + }, + { + "nct_id": "NCT01243255", + "brief_title": "Polish Survey on the Efficacy of the Hypercholesterolemia Treatment", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Hypercholesterolemia']", + "diseases_list": [ + "Hypercholesterolemia" + ], + "enrollment": "1500.0", + "inclusion_criteria": "inclusion criteria: \n\n Patients on lipid lowering drug treatment \n\n Lipid lowering drug treatment lasting at least 3 months \n\n No lipid lowering drug/dose change for a minimum 6 weeks prior to enrolment to the study \n\n ", + "exclusion_criteria": ": \n\n Lack of patient's signed informed consent form \n\n Lack of the blood sample taken for lipid profile and glucose within 10 days before or after assessment of the patient", + "brief_summary": "The purpose of the survey is to evaluate the efficacy of treatment of hypercholesterolemia in Polish patients who are currently on lipid- lowering pharmacological therapy . Efficient treatment is defined as achievement of the LDL cholesterol level goals according to the European Society of Cardiology 2007 guidlines.", + "NCTID": "NCT01243255", + "total_score": 0.1054315043406969, + "bm25_score": 0.03973073883107824, + "medcpt_score": 0.0657007655096186 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-20155", + "patient": "<0.> A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. <1.> Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. <2.> For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. <3.> She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain. <4.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT02407106", + "brief_title": "Efficacy of BLIS K12 as Preventive Measure for Rheumatic Children", + "phase": "", + "drugs": "['Streptococcus Salivarius BLIS K12']", + "drugs_list": [ + "Streptococcus Salivarius BLIS K12" + ], + "diseases": "['Rheumatic Fever']", + "diseases_list": [ + "Rheumatic Fever" + ], + "enrollment": "30.0", + "inclusion_criteria": "inclusion criteria: \n\n Rheumatic heart disease with recommended strep prophylaxis \n\n ", + "exclusion_criteria": ": \n\n less than one year from first diagnosis \n\n refusal to take the tablets", + "brief_summary": "The purpose of this study is to determine whether daily treatment with Streptococcus Salivarius BLIS K-12 prevents streptococcal throat infection in children that have had an episode of rheumatic fever.", + "NCTID": "NCT02407106", + "total_score": 0.15276127795538624, + "bm25_score": 0.07505939275015122, + "medcpt_score": 0.07770188520523504 + }, + { + "nct_id": "NCT02118818", + "brief_title": "RhEumatiC Heart diseAse Genetics", + "phase": "", + "drugs": "['Next generation sequencing']", + "drugs_list": [ + "Next generation sequencing" + ], + "diseases": "['Rheumatic Heart Disease']", + "diseases_list": [ + "Rheumatic Heart Disease" + ], + "enrollment": "1000.0", + "inclusion_criteria": "inclusion criteria: \n\n Clinical and echocardiographic signs of RHD using WHF criteria \n\n ", + "exclusion_criteria": ": \n\n Congenital heart disease", + "brief_summary": "Rheumatic fever (RF) is an autoimmune disease that is mediated by the cellular and humoral immune response that follows an untreated pharyngeal Streptococcus pyogenes infection. The most serious complication is rheumatic heart disease (RHD), one of the most common problems facing children and young adults worldwide, which leads to chronic valvular lesions. It is estimated that 60% of all acute rheumatic fever cases will develop RHD.~The pathogenesis of RHD is complex with both environmental and genetic factors contributing to its etiology. The investigators know little about the genetic etiology, cellular events and modifiers of progression of RHD, and there exists a wide range of disease severity and progression to severe valve pathology.~Thus, the investigators will study the genetics of RHD in Rwanda, a country with a very high incidence of RHD, using a combination of next-generation targeted exome capture, transcriptomics, and expressed quantitative trait loci (eQTL) analysis.", + "NCTID": "NCT02118818", + "total_score": 0.15083728524147494, + "bm25_score": 0.06500633586768041, + "medcpt_score": 0.08583094937379455 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-20156", + "patient": "<0.> A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. <1.> She reports to have been eating more than normal and that her heart sometimes races for no reason. <2.> On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia. <3.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT02375451", + "brief_title": "Effect of Childhood Radioiodine Therapy on Salivary Function", + "phase": "", + "drugs": "['Radioiodine']", + "drugs_list": [ + "Radioiodine" + ], + "diseases": "['Xerostomia', 'Hyperthyroidism', 'Thyroid Cancer']", + "diseases_list": [ + "Xerostomia", + "Hyperthyroidism", + "Thyroid Cancer" + ], + "enrollment": "70.0", + "inclusion_criteria": "inclusion criteria: \n\n Patients who have been treated with radioiodine therapy \n\n Patients who have never received radioiodine therapy (negative control group) \n\n ", + "exclusion_criteria": ": \n\n Non-English speaking subjects will be excluded due to our lack of translation support resources at this time. Of note, participation in our study cannot benefit participants in any way.", + "brief_summary": "Radioiodine (I-131) therapy for thyroid disease is known to decrease salivary function in adult patients. The impact of pediatric I-131 exposure on salivary function is unknown. The investigators goals are to answer this question by measuring salivary gland function before and after I-131 administration in children who receive radioiodine therapy at our hospital for thyroid disease.", + "NCTID": "NCT02375451", + "total_score": 0.1761541322721183, + "bm25_score": 0.09315429996422733, + "medcpt_score": 0.08299983230789094 + }, + { + "nct_id": "NCT01717352", + "brief_title": "Sleep Plus Eating Routines for Weight Loss", + "phase": "Phase 2", + "drugs": "['Weight Loss Education', 'Sleep and Eating Routine']", + "drugs_list": [ + "Weight Loss Education", + "Sleep and Eating Routine" + ], + "diseases": "['Overweight and Obesity']", + "diseases_list": [ + "Overweight and Obesity" + ], + "enrollment": "90.0", + "inclusion_criteria": "inclusion criteria: \n\n age 21 to 65 \n\n BMI 25 to 45 \n\n sleep 7 hours or less most nights \n\n ", + "exclusion_criteria": ": \n\n use of medications affecting sleep \n\n sleep apnea \n\n shift work", + "brief_summary": "The present study will test the effectiveness of two different approaches for preparing overweight/obese individuals for weight loss: 1)providing important information about weight control, including dispelling common myths; or 2) developing a consistent sleep and eating routine to prepare for the challenges of a weight control intervention.", + "NCTID": "NCT01717352", + "total_score": 0.152918543531172, + "bm25_score": 0.09255061671728339, + "medcpt_score": 0.06036792681388861 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-20157", + "patient": "<0.> A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. <1.> She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. <2.> She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. <3.> Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits. <4.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT02633449", + "brief_title": "Psychotherapy Plus: Combining Cognitive Behavioral Therapy With tDCS", + "phase": "", + "drugs": "['cognitive behavioral therapy', 'tDCS', 'sham-tDCS']", + "drugs_list": [ + "cognitive behavioral therapy", + "tDCS", + "sham-tDCS" + ], + "diseases": "['Major Depression']", + "diseases_list": [ + "Major Depression" + ], + "enrollment": "209.0", + "inclusion_criteria": "inclusion criteria: \n\n - unipolar major depressive disorder \n\n ", + "exclusion_criteria": ": \n\n neurological diseases or relevant psychiatric diseases other than major depressive disorder \n\n current medication other than SSRI or Mirtazapine \n\n manic episodes (lifetime) \n\n psychotic symptoms (lifetime) \n\n treatment with psychotherapy within the past 2 years \n\n treatment with electroconvulsive therapy (lifetime)", + "brief_summary": "The study will investigate whether cognitive behavioral psychotherapy (CBT) combined with prefrontal transcranial direct current stimulation (tDCS) is more efficacious with regard to symptom reduction in depressed patients than CBT combined with sham-tDCS or CBT alone.", + "NCTID": "NCT02633449", + "total_score": 0.15060591135267198, + "bm25_score": 0.0728896103896104, + "medcpt_score": 0.07771630096306159 + }, + { + "nct_id": "NCT01632319", + "brief_title": "Therapy for Undergraduate College Students Who Binge Drink and Are Depressed", + "phase": "", + "drugs": "['Combined Motivational Interviewing and Cognitive Behavioral Therapy', 'Cognitive Behavioral Therapy']", + "drugs_list": [ + "Combined Motivational Interviewing and Cognitive Behavioral Therapy", + "Cognitive Behavioral Therapy" + ], + "diseases": "['Depression', 'Alcohol Abuse']", + "diseases_list": [ + "Depression", + "Alcohol Abuse" + ], + "enrollment": "96.0", + "inclusion_criteria": "inclusion criteria: \n\n Currently enrolled in college as an undergraduate student. \n\n Ages 18-24 years (inclusive). \n\n Presence of two binge drinking episodes in the past month (defined as consumption of 5 or more drinks in 2 hours for males and 4 for females; NIAAA, 2004). \n\n BDI-II 12 (12 is often used to indicate the presence of at least mild depressive symptoms) and <30 (indicating severe depression). \n\n ", + "exclusion_criteria": ": \n\n Meeting criteria for substance dependence or abuse (any substance) in the past six months (students with alcohol abuse will not be excluded). \n\n Diagnosis of bulimia, psychosis, or bipolar disorder. \n\n Having received any psychosocial treatment for depression or substance abuse in the past month. \n\n Having received CBT for depression and/or alcohol use in the previous 6 months. \n\n If receiving pharmacological treatment for depression or substance abuse, has not been on a stable dose for at least 4 weeks. \n\n Discontinued an antidepressant medication less than 1 month ago. \n\n Meeting criteria for severe depression or posing a serious suicide or homicide risk.", + "brief_summary": "The purpose of this study is to investigate the effectiveness of 2 different therapy courses for undergraduate college students who binge drink and experience depressive symptoms.", + "NCTID": "NCT01632319", + "total_score": 0.14102260184592777, + "bm25_score": 0.06919186442608694, + "medcpt_score": 0.07183073741984082 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-20158", + "patient": "<0.> A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. <1.> No history of headache or night terrors. <2.> The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. <3.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT00393913", + "brief_title": "Evaluating the Relationship Between Sleep-Disordered Breathing and Daytime Alertness", + "phase": "", + "drugs": "['Continuous Positive Airway Pressure (CPAP)']", + "drugs_list": [ + "Continuous Positive Airway Pressure (CPAP)" + ], + "diseases": "['Sleep Apnea, Obstructive']", + "diseases_list": [ + "Sleep Apnea", + "Obstructive" + ], + "enrollment": "144.0", + "inclusion_criteria": "inclusion criteria: \n\n Experiences symptoms of OSA, including snoring and sleepiness \n\n Stable medical history with no change in medications that could affect sleepiness \n\n ", + "exclusion_criteria": ": \n\n Suspected diagnosis of a sleep disorder other than OSA (i.e., periodic leg movements, narcolepsy, insomnia, central sleep apnea, sleep hypoventilation syndrome) \n\n Medically unstable health conditions (e.g., heart attack, congestive heart failure) \n\n Use of psychotropic medications that cause sedation in the 3 months prior to study entry \n\n Recent or confirmed history of recreational drug use or alcohol abuse \n\n Pregnant \n\n Inability to communicate verbally, write, or read \n\n Visual, hearing, or cognitive impairment", + "brief_summary": "Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person repeatedly stops breathing, or experiences shallow breathing for short periods of time during sleep. Daytime sleepiness is a common symptom of OSA and may affect an individual's level of alertness throughout the day. The primary purpose of this study is to evaluate the relationship between the severity of sleep-disordered breathing and levels of daytime alertness at baseline (untreated state) in a group of subjects with and without sleep apnea. In addition the change in daytime sleepiness in subjects with sleep apnea being treated with a continuous positive airway pressure (CPAP) machine, a common treatment for OSA will also be assessed.", + "NCTID": "NCT00393913", + "total_score": 0.20004578754578756, + "bm25_score": 0.09972527472527473, + "medcpt_score": 0.10032051282051282 + }, + { + "nct_id": "NCT02562040", + "brief_title": "Pediatric Adenotonsillectomy Trial for Snoring", + "phase": "", + "drugs": "['Early Adenotonsillectomy (eAT)', 'Watchful Waiting with Supportive Care (WWSC)']", + "drugs_list": [ + "Early Adenotonsillectomy (eAT)", + "Watchful Waiting with Supportive Care (WWSC)" + ], + "diseases": "['Sleep-Disordered Breathing']", + "diseases_list": [ + "Sleep-Disordered Breathing" + ], + "enrollment": "459.0", + "inclusion_criteria": "inclusion criteria: \n\n Diagnosis of mild sleep-disordered breathing (MSDB) defined as meeting all of the following criteria: \n\n Caregiver report of habitual snoring that occurs most of the night on at least three nights per week, and has been present for at least three months (on average occurring > 3 nights per week or more half of sleep time) and \n\n Centrally-scored polysomnogram (PSG) confirming an obstructive apnea index (OAI) <1/hour and apnea-hypopnea index (AHI) \u22643/hour and no oxygen saturation (SpO2) desaturation < 90% in conjunction with obstructive events, confirmed on PSG. \n\n Tonsillar hypertrophy \u22652 based on a standardized scale of 0-4. \n\n Deemed to be a candidate for AT by otolaryngologist (ENT) evaluation (i.e., no technical issues that would be a contraindication for surgery such as submucous cleft palate.) \n\n Primary indication for AT is nocturnal obstructive symptoms (i.e., not recurrent infections or other indications). \n\n ", + "exclusion_criteria": ": \n\n Previous tonsillectomy, including partial tonsillectomy \n\n Recurrent tonsillitis that merits prompt adenotonsillectomy (AT) per the American Academy of Otolaryngology-Head and Neck Surgery Clinical Practice Guidelines (i.e., \u22657 episodes/yr in the past year; \u22655 episodes/year over the past 2 years or \u22653 episodes/yr over the past 3 years.) \n\n Severe obesity (body mass index (BMI) z-score \u22653). \n\n Failure to thrive, defined as either height or weight being below the 5th percentile for age and gender. \n\n Severe chronic health conditions that might hamper participation or confound key variables under study, including but not limited to: \n\n Severe cardiopulmonary disorders such as cystic fibrosis, and congenital heart disease. \n\n Bleeding disorders \n\n Sickle Cell Disease \n\n Epilepsy requiring medication \n\n Significant cardiac arrhythmia noted on PSG including: non-sustained ventricular tachycardia, atrial fibrillation, second degree atrioventricular block, sustained bradycardia, or sustained tachycardia. \n\n Other severe chronic health problems such as diabetes, narcolepsy, and poorly controlled asthma. \n\n Known genetic, craniofacial, neurological or psychiatric conditions likely to affect the airway, cognition or behavior; \n\n Current use of psychotropic medication (other than medications for attention deficit hyperactivity disorder, hypnotics, antihypertensives, hypoglycemic agents including insulin, anticonvulsants, anticoagulants, or growth hormone. \n\n Diagnosis of autism spectrum disorder. \n\n Intellectual deficit or assigned to a self-contained classroom for all academic subjects. \n\n History of severe developmental disability or Adaptive Behavior Assessment System (ABAS-3) score \u226460. \n\n Children/caregivers planning to move out of the area within the year. \n\n Children in foster care. \n\n Children/caregivers who do not speak English or Spanish well enough to complete the neurobehavioral measures.", + "brief_summary": "The purpose of this study is to evaluate the effects of early adenotonsillectomy (eAT) on the behavior, sleep-disordered breathing symptoms and quality of life for children who snore, but do not have obstructive sleep apnea, as well as identify factors that moderate responses to the surgery. Half of participants will receive eAT, while the other half will be observed with watchful waiting and supportive care.", + "NCTID": "NCT02562040", + "total_score": 0.1732027037290195, + "bm25_score": 0.0770771626034784, + "medcpt_score": 0.09612554112554113 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-20159", + "patient": "<0.> A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. <1.> Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. <2.> Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. <3.> Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. <4.> Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. <5.> Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. <6.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT01766830", + "brief_title": "Rapid Diagnostic Tests and Clinical/Laboratory Predictors of Tropical Diseases In Patients With Persistent Fever in Cambodia, Nepal, Democratic Republic of the Congo and Sudan (NIDIAG-Fever)", + "phase": "", + "drugs": "['rk28 ICT', 'IT LEISH (rK39)', 'Immunochromatographic HAT test', 'HAT Serostrip', 'Card Agglutination Trypanosoma Test (CATT)-10', 'Typhidot M', 'S. typhi IgM/IgG', 'Test-it Typhoid IgM', 'Test-it Leptospirosis IgM', 'Leptospira IgG/IgM']", + "drugs_list": [ + "rk28 ICT", + "IT LEISH (rK39)", + "Immunochromatographic HAT test", + "HAT Serostrip", + "Card Agglutination Trypanosoma Test (CATT)-10", + "Typhidot M", + "S. typhi IgM/IgG", + "Test-it Typhoid IgM", + "Test-it Leptospirosis IgM", + "Leptospira IgG/IgM" + ], + "diseases": "['Visceral Leishmaniasis', 'Human African Trypanosomiasis', 'Enteric Fever', 'Melioidosis', 'Brucellosis', 'Leptospirosis', 'Relapsing Fever', 'Rickettsial Diseases', 'HIV', 'Tuberculosis', 'Malaria', 'Amoebic Liver Abscess']", + "diseases_list": [ + "Visceral Leishmaniasis", + "Human African Trypanosomiasis", + "Enteric Fever", + "Melioidosis", + "Brucellosis", + "Leptospirosis", + "Relapsing Fever", + "Rickettsial Diseases", + "HIV", + "Tuberculosis", + "Malaria", + "Amoebic Liver Abscess" + ], + "enrollment": "1927.0", + "inclusion_criteria": "inclusion criteria: \n\n fever for \u2265 1 week \n\n \u2265 5 years old (18 years onward in Cambodia) \n\n ", + "exclusion_criteria": ": \n\n unwilling or unable to give written informed consent \n\n unable in the study physician's opinion to comply with the study requirements \n\n existing laboratory confirmed diagnosis \n\n need of immediate intensive care due to shock or respiratory distress", + "brief_summary": "Tropical fevers have been a diagnostic challenge from the antiquity. Nowadays, despite the availability of good diagnostic capacities, undifferentiated febrile illnesses continue to be a thorny problem for travel physicians. In developing countries, the scarcity of skilled personnel and adequate laboratory facilities makes the differential diagnosis of fevers even more complex. Health care workers must often rely on syndrome-oriented empirical approaches to treatment and might overestimate or underestimate the likelihood of certain diseases. For instance Neglected Tropical Diseases (NTD) contribute substantially to the burden of persistent (more than 1 week) fevers in the Tropics, causing considerable mortality and major disability. These diseases are however rarely diagnosed at primary health care (PHC) level. The difficulty in establishing the cause of febrile illnesses has resulted in omission or delays in treatment, irrational prescriptions with polytherapy, increasing cost and development of drug resistance.~In resource-limited settings, clinical algorithms constitute a valuable aid to health workers, as they facilitate the therapeutic decision in the absence of good laboratory capacities. There is a critical lack of appropriate diagnostic tools to guide treatment of NTDs. While clinical algorithms have been developed for some NTDs, in most cases they remain empirical. Besides, they rarely take into account local prevalence data, do not adequately represent the spectrum of patients and differential diagnosis at the primary care level and often have not been properly validated. The purpose of the study is to develop evidence-based Rapid Diagnostic Test (RDT)-supported diagnostic guidelines for patients with persistent fever (\u2265 1 week) in the Democratic Republic of the Congo (DRC), Sudan, Cambodia and Nepal.", + "NCTID": "NCT01766830", + "total_score": 0.14128208861297248, + "bm25_score": 0.05252478548336023, + "medcpt_score": 0.08875730312961225 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201510", + "patient": "<0.> A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. <1.> Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26. <2.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT02340533", + "brief_title": "Histopathological Diagnosis of Adenomyosis", + "phase": "", + "drugs": "['hysteroscopic endo-myometrial biopsy', 'ultrasound']", + "drugs_list": [ + "hysteroscopic endo-myometrial biopsy", + "ultrasound" + ], + "diseases": "['Adenomyosis']", + "diseases_list": [ + "Adenomyosis" + ], + "enrollment": "200.0", + "inclusion_criteria": "inclusion criteria: \n\n females complaining of pelvic congestion: dysmenorrhea, dyspareunia, chronic pelvic pain, menorrhagia, metrorrhagia \n\n ", + "exclusion_criteria": ": \n\n refusal of the patient to get enrolled in the study", + "brief_summary": "The purpose of this study is to develop and evaluate a hysteroscopic endo-myometrial biopsy for diagnosing adenomyosis.", + "NCTID": "NCT02340533", + "total_score": 0.20338168660863695, + "bm25_score": 0.08578428401123439, + "medcpt_score": 0.1175974025974026 + }, + { + "nct_id": "NCT01377519", + "brief_title": "Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids", + "phase": "", + "drugs": "['MR Guided Focused Ultrasound', 'Placebo MR Guided Focused Ultrasound']", + "drugs_list": [ + "MR Guided Focused Ultrasound", + "Placebo MR Guided Focused Ultrasound" + ], + "diseases": "['Uterine Fibroids']", + "diseases_list": [ + "Uterine Fibroids" + ], + "enrollment": "20.0", + "inclusion_criteria": "inclusion criteria: \n\n Age>18 years \n\n Premenopausal \n\n Symptomatic fibroids \n\n Fibroids accessible for focused ultrasound treatment \n\n ", + "exclusion_criteria": ": \n\n Desires future fertility \n\n Current pregnancy \n\n Hematocrit <30% \n\n Emergency room visit in last 3 months for fibroid symptoms \n\n History of venous thromboembolism \n\n Fibroids that are: >10cm, non-enhancing with contrast \n\n Adenomyosis \n\n Contraindications to undergoing MRI \n\n Unexplained menstrual irregularity", + "brief_summary": "This is a pilot randomized, blinded, placebo-controlled trial of a noninvasive, FDA approved treatment for uterine fibroids called MR Guided Focused Ultrasound (MRgFUS). Our hypothesis is that MRgFUS provides superior relief of fibroid symptoms compared with the placebo, a sham MRgFUS treatment. The investigators will recruit 20 premenopausal women with symptomatic uterine fibroids to participate in the trial. Participants will be randomly assigned in a 2:1 ratio to the active treatment arm (MRgFUS) versus the sham MRgFUS treatment. Participants will remain blinded to their group assignment for 3 months. After 3 months, participants will be told their treatment group and those assigned to the sham group will be offered complimentary MRgFUS if they desire it. Women will be excluded if they are inappropriate candidates for a 3 month delay in fibroid treatment, such as those with significant anemia. The investigators will assess the change from baseline to 1 and 3 months after treatment in fibroid symptoms, quality of life, fibroid volume measured by MRI, and hematocrit.", + "NCTID": "NCT01377519", + "total_score": 0.174095688274258, + "bm25_score": 0.05878167861242222, + "medcpt_score": 0.11531400966183575 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201511", + "patient": "<0.> A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. <1.> She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. <2.> Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. <3.> She moves and talks slowly. <4.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT01862510", + "brief_title": "Detection of Celiac Disease in Patients With Hypothyroidism", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Celiac Disease', 'Hypothyroidism', 'Celiac Sprue', 'Malabsorption']", + "diseases_list": [ + "Celiac Disease", + "Hypothyroidism", + "Celiac Sprue", + "Malabsorption" + ], + "enrollment": "500.0", + "inclusion_criteria": "inclusion criteria: \n\n Patients with the diagnosis of hypothyroidism that require thyroid replacement therapy. \n\n ", + "exclusion_criteria": ": \n\n Surgical resection of thyroid tissue, neck irradiation, radioactive iodine therapy, prior medical treatment with lithium, methimazole, propylthiouracil, ethionamide, amiodarone, or sunitinib, prior serologic testing for celiac disease.", + "brief_summary": "The study evaluates whether hypothyroid patients requiring elevated doses of levothyroxine to maintain a euthyroid state are at increased risk of having celiac disease. It also attempts to determine if there is a threshold level of levothyroxine needed to maintain a euthyroid state in patients with hypothyroidism that should prompt serologic testing for celiac disease.", + "NCTID": "NCT01862510", + "total_score": 0.15977304880412593, + "bm25_score": 0.07980764149242411, + "medcpt_score": 0.07996540731170182 + }, + { + "nct_id": "NCT01197183", + "brief_title": "Observational Study With Prospective and/or Retrospective Follow-up, Without Modifying Patient Treatment and Follow-up Practices for the Initial Treatment of Hypothyroidism in France", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Hypothyroidism']", + "diseases_list": [ + "Hypothyroidism" + ], + "enrollment": "1285.0", + "inclusion_criteria": "inclusion criteria: \n\n Recently diagnosed hypothyroid subject (either during the inclusion period, or within the 6 previous months) for whom, data related to the diagnosis is available if the diagnosis was not carried out initially by the investigating doctor \n\n Subject, who has given his/her oral consent for participation \n\n ", + "exclusion_criteria": ": \n\n Subject included in clinical trial or having participated in a clinical trial during the last 3 months \n\n Subject presenting a major and objectifiable risk of not being able to follow-up until the next TSH level (moving, problems encountered during another study, pathology affecting the vital prognosis in the short-term) \n\n All contraindications to L\u00e9vothyrox", + "brief_summary": "This observational survey with prospective and/or retrospective follow-up is designed to study practices for the initial treatment of hypothyroidism in France without modifying subject treatment.", + "NCTID": "NCT01197183", + "total_score": 0.1564566511207446, + "bm25_score": 0.07490690435718449, + "medcpt_score": 0.08154974676356022 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201512", + "patient": "<0.> A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. <1.> In the emergency room, he noted clear fluid dripping from his nose. <2.> The following day he started complaining of severe headache and fever. <3.> Nuchal rigidity was found on physical examination. <4.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT02418169", + "brief_title": "Association Between Craniofacial Fractures and Brain Injuries: Diagnostic and Therapeutic Considerations", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Brain Injuries', 'Skull Fractures']", + "diseases_list": [ + "Brain Injuries", + "Skull Fractures" + ], + "enrollment": "1000.0", + "inclusion_criteria": "inclusion criteria: \n\n Severe traumatic brain injury, GCS 8 or less and/or Craniofacial fracture \n\n ", + "exclusion_criteria": ": \n\n Died before admitted to hospital", + "brief_summary": "This study evaluates the association between traumatic brain injuries and craniofacial or/and skull fractures. Purpose is to find out the amount of missed diagnoses and improve primary diagnostics of trauma patients.", + "NCTID": "NCT02418169", + "total_score": 0.19336994521475245, + "bm25_score": 0.09546068235723408, + "medcpt_score": 0.09790926285751832 + }, + { + "nct_id": "NCT02467309", + "brief_title": "Vitamin d Levels in Children With Bacterial Meningitis", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Bacterial Meningitis']", + "diseases_list": [ + "Bacterial Meningitis" + ], + "enrollment": "50.0", + "inclusion_criteria": "inclusion criteria: \n\n Probable bacterial meningitis patients: Clinical manifestation (Any person with sudden onset of fever (> 38.5 \u00b0C rectal or 38.0 \u00b0C axillary) and one of the following signs: neck stiffness, altered consciousness or other meningeal sign) with cerebrospinal fluid examination showing at least one of the following: \n\n A. turbid appearance; B.leukocytosis (> 100 cells/mm3); C.leukocytosis (10-100 cells/ mm3) AND either an elevated protein (> 100 mg/dl) or decreased glucose (< 40 mg/dl) \n\n Confirmed bacterial meningitis patients: A case that is laboratory-confirmed by growing (i.e. culturing) or identifying (i.e. by Gram stain or antigen detection methods) a bacterial pathogen (Hib, pneumococcus or meningococcus) in the cerebrospinal fluid or from the blood in a child with a clinical syndrome consistent with bacterial meningitis \n\n ", + "exclusion_criteria": ": \n\n Congenital immunodeficiency patients \n\n HIV patients \n\n Patients with corticosteroid treatment for long time \n\n Patients with disorders in adrenal gland and pituitary gland and hypothalamus \n\n Patients with tuberculosis", + "brief_summary": "The purpose of this study is to determine whether deficiency of Vitamin D has association with outcomes of children with bacterial meningitis.", + "NCTID": "NCT02467309", + "total_score": 0.16560098073045643, + "bm25_score": 0.06919253812636164, + "medcpt_score": 0.09640844260409477 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201513", + "patient": "<0.> A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. <1.> He is toxic-appearing, and leans forward while sitting on his mother's lap. <2.> He is drooling and speaks with a muffled \"hot potato\" voice. <3.> The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. <4.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT00315042", + "brief_title": "TELI TON - Telithromycin in Tonsillitis", + "phase": "Phase 3", + "drugs": "['Telithromycin (HMR3647)', 'Penicillin']", + "drugs_list": [ + "Telithromycin (HMR3647)", + "Penicillin" + ], + "diseases": "['Tonsillitis', 'Pharyngitis']", + "diseases_list": [ + "Tonsillitis", + "Pharyngitis" + ], + "enrollment": "314.0", + "inclusion_criteria": "inclusion criteria: \n\n Age 6 months to less than 13 years of age (<13); \n\n Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on: \n\n A positive result from a rapid detection throat swab test for Group A streptococcal antigen and submission of a throat swab specimen for bacterial culture, identification, and antibiotic-susceptibility testing; and \n\n A sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs: \n\n Tonsil and/or pharyngeal erythema and/or exudate; \n\n Cervical adenopathy; \n\n Uvular edema; \n\n Fever \n\n ", + "exclusion_criteria": ": \n\n Symptoms that collectively suggest nonstreptococcal T/P (eg, laryngitis, coryza, conjunctivitis, diarrhea, cough); \n\n History of positive throat culture for Streptococcus pyogenes in the absence of clinical signs and symptoms of T/P; \n\n Infection of the deep tissues of the upper respiratory tract (eg, epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (eg, sinusitis, otitis media, or orbital/periorbital cellulitis); \n\n History of rheumatic heart disease; \n\n Females of childbearing potential (ie, have reached menarche); \n\n Known congenital prolonged QT syndrome; \n\n Known or suspected uncorrected hypokalemia (\u22643 mmol/L [mEq/L]), or hypomagnesemia or bradycardia (<50 bpm); \n\n Myasthenia gravis; \n\n Known impaired renal function, as shown by creatinine clearance \u226425 mL/min \n\n The subject: \n\n Is being treated with drugs not permitted by the study protocol ie, cisapride, pimozide, astemizole, terfenadine, ergotamine, dihydroergotamine, Class IA (eg, quinidine and procainamide) or Class III (eg, dofetilide) antiarrhythmic agents, simvastatin, lovastatin and atorvastatin; \n\n Is currently being treated with systemic antibacterials or has been treated with systemic antibacterials within 14 days prior to enrollment;- Has been treated with any investigational medication within the last 30 days; \n\n Has been treated with rifampicin, phenytoin, carbamazepine, or St. John's wort within the last 2 weeks. \n\n History of hypersensitivity or intolerance to macrolides, penicillins, or cephalosporins; \n\n Previous enrollment in this study or previous treatment with telithromycin; \n\n Children of the investigator or subinvestigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the protocol.", + "brief_summary": "This is a multinational, randomized (1:1), double blind, double dummy, comparator-controlled, 2 parallel treatment group study in subjects from 6 months to < 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P).Each subject will receive either telithromycin 25 mg/kg once daily for 5 days or penicillin V, 13.3 mg/kg three times daily for 10 days. Matching placebo for telithromycin and penicillin V will also be dispensed for 5 and 10 days respectively, to provide blinding to the different treatment regimens. A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.", + "NCTID": "NCT00315042", + "total_score": 0.18008786941991714, + "bm25_score": 0.06781540531540532, + "medcpt_score": 0.11227246410451179 + }, + { + "nct_id": "NCT01255670", + "brief_title": "Penicillin and Metronidazole in Treatment of Peritonsillar Abscess", + "phase": "", + "drugs": "['penicillin and metronidazole in peritonsillar abscess']", + "drugs_list": [ + "penicillin and metronidazole in peritonsillar abscess" + ], + "diseases": "['Peritonsillar Abscess']", + "diseases_list": [ + "Peritonsillar Abscess" + ], + "enrollment": "200.0", + "inclusion_criteria": "inclusion criteria: \n\n referring doctor suspects peritonsillar abscess \n\n patient is voluntary \n\n patient has daily access to his/her e-mail \n\n patient speaks and understands Finnish of Swedish \n\n female patients have adequate birth-control method \n\n patient has peritonsillar abscess \n\n ", + "exclusion_criteria": ": \n\n allergy to penicillin \n\n allergy to metronidazole \n\n use of metronidazole in preceding one month \n\n pregnancy \n\n breast-feeding \n\n renal insufficiency \n\n liver insufficiency \n\n alcoholism (drunk at least once a week) \n\n participant in another clinical trial at the moment \n\n treatment of peritonsillar abscess requires in-patient care \n\n tonsillectomy during the next 30 days \n\n army recruit", + "brief_summary": "Treatment of peritonsillar abscess varies. To study whether broad spectrum antibiotics are required in addition to abscess drainage, a prospective, double blind, placebo-controlled, randomized study on 200 adult patients with peritonsillar abscess is performed. 100 patients are given penicillin and metronidazole and 100 patients get penicillin and placebo. Recovery and recurrence are analyzed.", + "NCTID": "NCT01255670", + "total_score": 0.10502374656346337, + "bm25_score": 0.028240336229632866, + "medcpt_score": 0.0767834103338305 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201514", + "patient": "<0.> A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. <1.> Further investigations reveal mild iron deficiency. <2.> She already receives iron supplementation. <3.> The obstetrician repeats the complete blood cell count 2 weeks later. <4.> The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. <5.> She describes difficulty swallowing. <6.> A reticulocyte count is performed and found elevated at 180 x 109/L. <7.> The obstetrician requests a hematology consult. <8.> The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. <9.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT00827463", + "brief_title": "Early Detection of Anaemia During the Maternity", + "phase": "Phase 3", + "drugs": "['dosage of the NFS and iron']", + "drugs_list": [ + "dosage of the NFS and iron" + ], + "diseases": "['Anemia']", + "diseases_list": [ + "Anemia" + ], + "enrollment": "80.0", + "inclusion_criteria": "inclusion criteria: \n\n Every patient followed at the HME at the beginnig of the pregnancy \n\n ", + "exclusion_criteria": ": \n\n pregnency women who don't speak french \n\n pregnancy women affected by b\u00e9ta thalassemia \n\n pregnancy woman having had a p\u00e9riconceptionnel treatment against the anaemia", + "brief_summary": "Estimate the efficiency of a strategy of premature screening of the maternal anaemia during the first quarter of pregnancy versus the usual strategy of screening of the anaemia during the sixth month.", + "NCTID": "NCT00827463", + "total_score": 0.2265617533590957, + "bm25_score": 0.09804204504185211, + "medcpt_score": 0.12851970831724352 + }, + { + "nct_id": "NCT01308112", + "brief_title": "Prenatal Iron and Malaria Study", + "phase": "Phase 4", + "drugs": "['iron']", + "drugs_list": [ + "iron" + ], + "diseases": "['Malaria']", + "diseases_list": [ + "Malaria" + ], + "enrollment": "470.0", + "inclusion_criteria": "inclusion criteria: \n\n Women aged 15-45 years resident in the predefined study area \n\n Pregnant, with gestational age <23 weeks \n\n ", + "exclusion_criteria": ": \n\n Failure to provide a blood sample \n\n Initial haemoglobin concentration <90 g/L \n\n Reported medical history suggestive of sickle cell anaemia, epilepsy, diabetes \n\n Obstetric history suggestive of eclampsia or pre-eclampsia \n\n Obvious mental retardation or metabolic disorder; \n\n No written consent \n\n Carrying multiples \n\n Woman planning to leave the homestead or to be absent for prolonged periods in the course of the pregnancy or within a 1-month period thereafter \n\n Woman planning to deliver outside the research clinic.", + "brief_summary": "The purpose of this study is to compare the presence of Plasmodium infection in parturient women who antenatally received a combination of iron-fortified foods with iron supplements versus iron-fortified foods only.", + "NCTID": "NCT01308112", + "total_score": 0.17360400064060233, + "bm25_score": 0.059697482110556366, + "medcpt_score": 0.11390651853004598 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201515", + "patient": "<0.> Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. <1.> At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. <2.> Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. <3.> She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. <4.> She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. <5.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT00932425", + "brief_title": "Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS)", + "phase": "", + "drugs": "['Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)']", + "drugs_list": [ + "Cardionet Mobile Cardiac Outpatient Telemetry (MCOT)" + ], + "diseases": "['Stroke']", + "diseases_list": [ + "Stroke" + ], + "enrollment": "40.0", + "inclusion_criteria": "inclusion criteria: \n\n Age > 18 years \n\n Seen at UCSF Medical Center for cryptogenic stroke or high-risk TIA \n\n Onset of stroke or TIA symptoms within the previous 60 days \n\n ", + "exclusion_criteria": ": \n\n Definite small-vessel etiology by history or imaging \n\n Source found on vascular imaging of possible culprit vessels \n\n Source found by echocardiography (TEE not required) \n\n History of atrial fibrillation \n\n Atrial fibrillation on admission ECG \n\n Atrial fibrillation detected by inpatient cardiac telemetry (at least 24 hours required) \n\n Obvious culpable systemic illness such as endocarditis \n\n Patient unable to provide written, informed consent", + "brief_summary": "Atrial fibrillation (AF) is a common and treatable cause of ischemic stroke, but it can be paroxysmal and asymptomatic, and therefore difficult to detect. Patients with stroke routinely undergo 24 hours of continuous cardiac telemetry during hospitalization for stroke as a means of excluding AF. Small studies indicate that extending the duration of monitoring with portable outpatient telemetry devices detects more cases of AF. However, these studies are small and lack control groups, and cannot demonstrate that prolonged cardiac monitoring detects more cases of AF than routine clinical follow-up. The investigators therefore propose a pilot study to determine the feasibility of randomizing patients to prolonged cardiac monitoring or routine clinical follow-up. The investigators will enroll 40 consecutive adult patients seen at the University of California at San Francisco (UCSF) Neurovascular service with cryptogenic stroke or high-risk TIA (ABCD2 score 4 or greater). Enrolled patients will be randomized in a 1:1 fashion. Group A will be assigned to wear an ambulatory cardiac event monitor for 21 days. Group B will be discharged home without a monitor and will serve as controls during routine clinical follow-up. The investigators' primary outcome will be feasibility, defined as more than 80% of randomized patients completing full clinical follow-up and more than 70% of cardiac monitoring if applicable. The investigators' secondary outcomes will be diagnoses of AF at 90 days and 1 year and diagnoses of recurrent stroke at 1 year.", + "NCTID": "NCT00932425", + "total_score": 0.16285627980547196, + "bm25_score": 0.07205141670628094, + "medcpt_score": 0.090804863099191 + }, + { + "nct_id": "NCT01550588", + "brief_title": "Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale (DEFENSE-PFO)", + "phase": "Phase 4", + "drugs": "['Device closure', 'Standard medical treatment']", + "drugs_list": [ + "Device closure", + "Standard medical treatment" + ], + "diseases": "['Patent Foramen Ovale']", + "diseases_list": [ + "Patent Foramen Ovale" + ], + "enrollment": "210.0", + "inclusion_criteria": "inclusion criteria: \n\n Subjects who have had a cryptogenic stroke within the previous 3 months, radiologically verified \n\n Subjects who have been diagnosed with a high-risk* Patent Foramen Ovale (PFO), echocardiographically verified (*PFO size \u2265 2 mm or atrial septal aneurysm or hypermobility by TEE) \n\n Subjects willing to participate in follow-up visits \n\n Absence of other potential causes of stroke \n\n ", + "exclusion_criteria": ": \n\n Any identifiable cause of thromboembolic cause other than PFO \n\n Subjects with intracardiac thrombus or tumor, dilated cardiomyopathy, prosthetic heart valve or mitral stenosis, endocarditis \n\n Subjects with significant atherosclerosis or dissection of the aorta, collagen vascular disease, arteritis, vasculitis and coagulopathy \n\n Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina \n\n Subjects who have a non-vascular origin of the neurological symptoms after brain imaging (CT scan or MRI) \n\n History of intracranial bleeding, confirmed arterio-venous malformation,aneurysm or uncontrolled coagulopathy \n\n Pre-existing neurological disorders or intracranial disease, e.g. multiple sclerosis \n\n Subjects with left ventricular aneurysm or akinesis \n\n Subjects with atrial fibrillation/atrial flutter (chronic or intermittent) \n\n Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum \n\n Subjects who could not undergo the TEE examination \n\n Subjects with contraindication to aspirin or Clopidogrel therapy \n\n Pregnant or desire to become pregnant within the next year \n\n Subjects who have a underlying malignancy", + "brief_summary": "Background and hypothesis:~The appropriate treatment strategy for secondary stroke prevention in patients with cryptogenic stroke and patent foramen ovale (PFO) remains challenging. Clinical and anatomical variables reported to be risk factors associated with stroke recurrence include older age, large PFO, large right-to-left shunting, and combined atrial septal aneurysm (ASA), which, however, were not confirmed by other studies. The investigators hypothesized that percutaneous closure of PFO could be an effective option for secondary prevention in cryptogenic stroke patients with high-risk PFO.~Trial Objective:~The primary objective of this study is to assess whether percutaneous device closure of PFO is superior to conventional antithrombotic treatment in preventing stroke recurrence in the cryptogenic stroke patients with high-risk PFO.", + "NCTID": "NCT01550588", + "total_score": 0.15251754589819427, + "bm25_score": 0.07007163145388356, + "medcpt_score": 0.08244591444431075 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201516", + "patient": "<0.> A 4 year old boy presents to the emergency room with wheezing. <1.> He has had a history of allergic rhinitis, but no history of wheezing. <2.> His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. <3.> The coughing lasted only moments, but he has been audibly wheezing since. <4.> Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. <5.> On exam, the child is playful and well appearing. <6.> Wheezing is heard in the mid-right chest area. <7.> O2 sats are 100% on room air. <8.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT00839124", + "brief_title": "A Study of Inhalation of 20,000 EU CCRE in Normal Volunteers Compared to Allergic Asthmatic Individuals", + "phase": "Phase 1", + "drugs": "['Clinical Center Reference Endotoxin (CCRE)', 'Clinical Center Reference Endotoxin (CCRE)']", + "drugs_list": [ + "Clinical Center Reference Endotoxin (CCRE)", + "Clinical Center Reference Endotoxin (CCRE)" + ], + "diseases": "['Asthma', 'Hypersensitivity']", + "diseases_list": [ + "Asthma", + "Hypersensitivity" + ], + "enrollment": "32.0", + "inclusion_criteria": "inclusion criteria for healthy controls: \n\n Normal lung function, defined as (Knudson 1976/1984 predicted set): \n\n FVC of > 80 % of that predicted for gender, ethnicity, age and height FEV1 of > 80 % of that predicted for gender, ethnicity, age and height FEV1/FVC ratio of > .75 \n\n Oxygen saturation of > 94 % and normal blood pressure (Systolic between 150 - 90, Diastolic between 90-60 mm Hg) \n\n Symptom Score no greater than 6 (out of a possible 24) for total symptom score with a value no greater than 2 for any one score. \n\n Negative methacholine inhalation challenge as performed in the screening protocol. (Less than a 20% decrease in FEV1 at a maximum methacholine concentration of 10 mg/ml) \n\n --Negative pregnancy test for females \n\n Negative allergy skin test (AST) \n\n inclusion criteria for allergic asthmatics also include: \n\n History of episodic wheezing, chest tightness, or shortness of breath after age of 6 years consistent with asthma, or physician diagnosed asthma after age of 6 years. \n\n Positive methacholine test. \n\n FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70 (without use of bronchodilating medications for 12 hours) \n\n Allergic sensitization to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive AST. \n\n Negative allergy skin test as performed in the screening protocol. \n\n ", + "exclusion_criteria": ": \n\n Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, or chronic thyroid disease. \n\n Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months. \n\n Use of systemic steroid therapy within the preceding 12 months for an asthma exacerbation. All use of systemic steroids in the last year will be reviewed by a study physician. \n\n Use of inhaled steroids, cromolyn or leukotriene inhibitors (montelukast or zafirlukast) except for use of cromolyn exclusively prior to exercise. \n\n Use of daily theophylline within the past month. \n\n Use of tricyclics and MAO inhibitors \n\n Pregnancy or nursing a baby. \n\n Cigarette smoking > 1 pack per month. \n\n Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. \n\n Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. \n\n Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to include prophylactic use of albuterol prior to exercise). \n\n Viral upper respiratory tract infection within 2 weeks of challenge. \n\n Any acute infection requiring antibiotics within 2 weeks of challenge \n\n Receipt of LAIV (Live Attenuated Influenza Vaccine), also know as FluMist\u00ae, within the prior 14 days", + "brief_summary": "This will be a single center, open label study comparing baseline characteristics of recovered sputum cells (collected on screening day) to those of cells recovered 6 hours after inhalational challenge with 20,000 EU Clinical Center Reference Endotoxin (CCRE, a component of air pollution)) within each group as well as cross group comparisons between individuals with allergic asthma (AA's)and normal volunteers (NV's). The primary objective of this study is to test the hypothesis that persons with allergic asthma will have an increased neutrophil response to challenge with 20,000 EU CCRE compared to normal volunteers. Secondary objectives include post CCRE comparison between AA's and NV's with regard to changes in airway cells and blood as well as changes in mucociliary clearance (MCC) in response to inhalation of 20,000 EU CCRE.", + "NCTID": "NCT00839124", + "total_score": 0.18137173124978004, + "bm25_score": 0.09267676767676769, + "medcpt_score": 0.08869496357301236 + }, + { + "nct_id": "NCT00930826", + "brief_title": "Childhood Asthma and Schooling: The Truth Unveiled", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Bronchial Asthma']", + "diseases_list": [ + "Bronchial Asthma" + ], + "enrollment": "450.0", + "inclusion_criteria": "inclusion criteria: \n\n Clinical diagnosis of bronchial asthma \n\n Must be able to swallow tablets \n\n ", + "exclusion_criteria": ": \n\n Steroid inhalation or ingestion", + "brief_summary": "Childhood Asthma and Schooling: The Truth Unveiled.", + "NCTID": "NCT00930826", + "total_score": 0.14992529612094832, + "bm25_score": 0.06833166833166833, + "medcpt_score": 0.08159362778927996 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201517", + "patient": "<0.> A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. <1.> She reports no complaints and is in general good health. <2.> The results of her PAP were cytology negative, HPV positive. <3.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT01446198", + "brief_title": "Clinical Evaluation of the APTIMA\u00ae HPV Assay Using the PANTHER\u2122 System", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Human Papilloma Virus Infection']", + "diseases_list": [ + "Human Papilloma Virus Infection" + ], + "enrollment": "11816.0", + "inclusion_criteria": "inclusion criteria: \n\n the sample had an aliquot with a valid positive or negative APTIMA HPV Assay TIGRIS System result (from testing under protocol 2007HPVASCUS30) \n\n an aliquot is available and suitable for testing, and \n\n the sample was randomly selected for inclusion. \n\n ", + "exclusion_criteria": ": \n\n sample integrity was compromised (eg, stored under unacceptable conditions)", + "brief_summary": "The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.", + "NCTID": "NCT01446198", + "total_score": 0.09761904761904762, + "bm25_score": 0.05, + "medcpt_score": 0.047619047619047616 + }, + { + "nct_id": "NCT01231945", + "brief_title": "Low-Cost Molecular Cervical Cancer Screening Study", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['DNA Probes', 'E6 Protein', 'Uterine Cervical Neoplasms', 'HPV']", + "diseases_list": [ + "DNA Probes", + "E6 Protein", + "Uterine Cervical Neoplasms", + "HPV" + ], + "enrollment": "7500.0", + "inclusion_criteria": "inclusion criteria: \n\n have not been previously diagnosed with cervical cancer \n\n have a cervix \n\n are not pregnant \n\n are physically able to undergo routine cervical cancer screening 5) are able to provide informed consent \n\n We will not exclude women if they have had previous cervical cancer screening because we assume that even if a few women have been screened for cervical cancer, the quality of cytology screening was very poor. \n\n ", + "exclusion_criteria": ": \n\n 1) are not married AND report never having had sexual intercourse 2) have had a total hysterectomy \n\n 3) have a history of cervical cancer \n\n 4) are physically or mentally unable to undergo routine cervical cancer screening or unable to provide informed consent. \n\n 5) are pregnant or have been pregnant in the last month \n\n -Women who are currently menstruating at the time of enrollment will be deferred from participating, and will become eligible to participate 7-14 days after menstruation has ended. The menstruating women will be advised to return for the screening 7 to 14 days after their menstrual period has concluded.", + "brief_summary": "Background:~- Low-cost molecular human papillomavirus (HPV) testing may offer a more robust alternative to Pap smears and visual inspection for cervical cancer screening of underserved women. Two low-cost molecular tests for human HPV, the HPV E6 Test and the careHPV test, have been developed to detect cervical cancer by testing for HPV DNA. These tests take between 2 and 3 hours to run and may provide point-of-care (diagnostic testing at or near the site of patient care) testing for HPV. Researchers are interested in evaluating both tests to determine the best strategy for HPV testing of women who live in rural or underserved areas that have a high prevalence of cervical cancer diagnoses.~Objectives:~To evaluate the clinical performance of the HPV E6 Test and careHPV in detecting cervical cancer and precancerous lesions.~To evaluate the best low-cost test or combination of tests for women who have been referred for cervical cancer screening or treatment.~To compare the clinical performance of self-collected specimens versus clinician-collected specimens in detecting cervical cancer and precancerous lesions.~Eligibility:~- Women between 25 and 65 years of age who live in rural China.~Design:~This study involves an initial testing visit and a 1-year followup visit for a high-risk subgroup.~Participants will have the HPV E6 test, careHPV, and a visual inspection test for cervical cancer. For comparison, participants will also have the standard HPV test approved by the U.S. Food and Drug Administration.~Participants who test positive for HPV on any of the above tests will also have colposcopy to collect samples of cervical tissue for further study.~A random sample of women who test negative for HPV will also have colposcopy. Participants may also have biopsies if there is visual evidence of cervical abnormalities.~At the 1-year followup visit, participants in the high-risk subgroup will have the same tests as in the previous visit..", + "NCTID": "NCT01231945", + "total_score": 0.09761904761904762, + "bm25_score": 0.047619047619047616, + "medcpt_score": 0.05 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201518", + "patient": "<0.> A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. <1.> He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. <2.> Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. <3.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT00344513", + "brief_title": "Organized Program To Initiate Lifesaving Treatment In Hospitalized Patients With Heart Failure (OPTIMIZE-HF)", + "phase": "Phase 4", + "drugs": "['Beta-blockers including Carvedilol', 'ACE inhibitors']", + "drugs_list": [ + "Beta-blockers including Carvedilol", + "ACE inhibitors" + ], + "diseases": "['Heart Failure, Congestive']", + "diseases_list": [ + "Heart Failure", + "Congestive" + ], + "enrollment": "50000.0", + "inclusion_criteria": "inclusion criteria: \n\n Hospitalized for episode of worsening heart failure as primary cause of admission or significant heart failure symptoms that develop during the hospitalization when the initial reason for admission was not heart failure. \n\n Systolic dysfunction (LVEF < 40%) or heart failure symptoms in the setting of preserved systolic function (diastolic dysfunction). \n\n ", + "exclusion_criteria": ": \n\n This study has no ", + "brief_summary": "This program is designed to improve medical care and education of hospitalized patients with heart failure and accelerate the initiation of evidence-based heart failure guideline recommended therapies by administering them before hospital discharge. A registry component focusing on admission to discharge and 60- to 90-day follow-up is designed to evaluate the demographic, pathophysiologic, clinical, treatment, and outcome characteristics of patients hospitalized with heart failure.", + "NCTID": "NCT00344513", + "total_score": 0.1545227580586624, + "bm25_score": 0.07095112403935934, + "medcpt_score": 0.08357163401930306 + }, + { + "nct_id": "NCT00534066", + "brief_title": "Utility of Serial BNP Levels in Emergency Department CHF", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Congestive Heart Failure']", + "diseases_list": [ + "Congestive Heart Failure" + ], + "enrollment": "52.0", + "inclusion_criteria": "inclusion criteria: \n\n age18 or older \n\n primary diagnosis of CHF in the Emergency Department \n\n admission to the hospital or transfer to the Observation Unit \n\n ", + "exclusion_criteria": ": \n\n minors, prisoners,pregnant women,unable to provide consent \n\n unstable angina or acute myocardial infarction in the ED \n\n dialysis dependent patients \n\n use of nesiritide as a therapy in the ED", + "brief_summary": "The purpose of the study is to determine if a series of BNP blood tests performed on patients who present to the Emergency Department with congestive heart failure (CHF) can predict which patients may have adverse outcomes. If the BNP is shown to be predictive of bad outcomes in certain patients, those patients might receive more intensive therapy early to prevent such outcomes. This was a prospective trial enrolling patients who presented to the ED and were diagnosed with heart failure. Subjects had a blood test for BNP, which is elevated in the presence of heart failure, collected twelve hours after their initial clinical BNP was obtained in the ED. Demographics, history, length of hospital stay, and other approved data were collected. At 30 days and 6 months after discharge, a follow up call was made to determine if the subject had required additional emergency care, had been admitted to a hospital, or had died during that period of time.", + "NCTID": "NCT00534066", + "total_score": 0.13380482152801634, + "bm25_score": 0.057679071878886864, + "medcpt_score": 0.07612574964912945 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201519", + "patient": "<0.> A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. <1.> She is in moderate respiratory distress after walking from the waiting room to the examination room. <2.> Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. <3.> She has smoked 1 to 2 packs per days for the past 47 years. <4.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT00806091", + "brief_title": "Functional Proteomics of Alveolar Macrophages", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['COPD']", + "diseases_list": [ + "COPD" + ], + "enrollment": "72.0", + "inclusion_criteria": "inclusion criteria: \n\n COPD, smoker \n\n COPD, non smoker \n\n ", + "exclusion_criteria": ": \n\n none", + "brief_summary": "The purpose of this study is to obtain young white blood cells (monocytes) from the investigators donated blood for research into how these cells change into large, mature white blood cells (macrophages) and how smoking causes Chronic Obstructive Pulmonary Disease (COPD).", + "NCTID": "NCT00806091", + "total_score": 0.18096202307010922, + "bm25_score": 0.09432652369446824, + "medcpt_score": 0.08663549937564093 + }, + { + "nct_id": "NCT02213809", + "brief_title": "Case Method Education on COPD to General Practitioners", + "phase": "", + "drugs": "['Case method education in COPD', 'Traditional education in COPD']", + "drugs_list": [ + "Case method education in COPD", + "Traditional education in COPD" + ], + "diseases": "['COPD']", + "diseases_list": [ + "COPD" + ], + "enrollment": "822.0", + "inclusion_criteria": "inclusion criteria: \n\n Primary Health Care Centers (PHCC): >10.000 patients listed. >70% permanent employed general practitioners \n\n Patients: Diagnosis of COPD registered at the COPD. Grade of COPD 2-3 (GOLD) at the latest spirometry completed since 2008. \n\n ", + "exclusion_criteria": ": \n\n None", + "brief_summary": "Background:~COPD is an inflammatory and chronic obstructive lung disease, mainly caused by smoking. Most patients with COPD are discovered and treated in primary health care. Co-morbidity with heart disease, hypertension, diabetes, osteoporosis and underweight is common. It is important to diagnose COPD at an early stage, primarily to motivate smoking cessation, which is the most important factor for decelerating the progress of COPD. In addition, medication and rehabilitation to reduce symptoms of COPD can be given. Previous studies in Sweden have shown poor quality of primary health care provided to patients with COPD.~As general practitioners often deal with multiple medical problems and patients' motivation when diagnosing and treating COPD we hypothesize that case method education (see description under intervention) in COPD has better effect than traditional education (see description under intervention).This study aims to examine the effect of case method education on (1) learning in COPD among general practitioners and on (2) health in their patients with COPD.~Method:~Primary health care centers (PHCC) in Stockholm will be recruited. The PHCCs will be randomized to either case method education (n=9 PHCCs) or traditional education (n=9 PHCCs) in COPD for their general practitioners. The educations will be held during two times (two hours each) within a time range of three months, covering examination and treatment of patients with COPD. At least 10.000 patients should be listed at PHCCs included. Random sampling of 45 patients with COPD at stage 2-3 will be done from each PHCC. The patients will fill in a self-assessment questionnaire including CCQ, CAT and LINQ (see outcome measures) as well as questions about medication, exacerbations and other chronic diseases. The questionnaire will be sent to the patients 1-2 months before the education and 18 months after the education. Differences in assessments in the questionnaire before and after the education will be compared between the patients listed at the PHCCs that have received case method education vs. traditional education. In addition, general practitioners (approximately, n=180) at the PHCCs will fill in a questionnaire, immediately before and 12 months after the education, covering the learning outcomes in order to study differences in learning between the two intervention groups.", + "NCTID": "NCT02213809", + "total_score": 0.16792192123223978, + "bm25_score": 0.06594124490373734, + "medcpt_score": 0.10198067632850241 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201520", + "patient": "<0.> An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. <1.> He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. <2.> He is unable to dress, bathe, use the toilet, or walk independently. <3.> On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. <4.> The patient was alert and oriented to self and city but not year. <5.> He frequently interrupted the examiner. <6.> He repeatedly reached out to grab things in front of him, including the examiner's tie and face. <7.> He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. <8.> His speech was fluent, but he often used similar-sounding word substitutions. <9.> He could immediately recall three out of three words but recalled none of them after 5 minutes. <10.> Examination of the cranial nerves revealed clinically significant paratonic rigidity. <11.> Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. <12.> The reflexes in the legs were normal. <13.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT00880347", + "brief_title": "Blood Gene Expression Signature in Patients Diagnosed With Probable Alzheimer's Disease Compared to Patients Suffering From Other Types of Dementia", + "phase": "", + "drugs": "['Blood sampling']", + "drugs_list": [ + "Blood sampling" + ], + "diseases": "[\"Alzheimer's Disease\", 'Dementia']", + "diseases_list": [ + "Alzheimer's Disease", + "Dementia" + ], + "enrollment": "550.0", + "inclusion_criteria": "inclusion criteria: \n\n AD group : \n\n Male or female patient, aged \u2265 40 years old included at entry. \n\n Patients having a clinical diagnosis of probable AD according to DSM-IV TR [F00.xx] and National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria. \n\n Written informed consent obtained from the patient or, if appropriate, from legal representative according to local laws and regulations. \n\n Evidence that brain imaging (either cerebral CT-scan or cerebral MRI) was performed to settle the AD diagnosis, and that the results are compatible with AD diagnosis. \n\n Neurological exam without any particularities or without any specific focal signs likely to be related to other conditions than AD. \n\n Patient compliant with study procedures. \n\n Non AD demented group : \n\n Male or female patient, aged \u2265 40 years old included at entry. \n\n Patients having a clinical diagnosis of dementia which can be one of the following : \n\n VaD according to NINDS-AIREN criteria or, \n\n LBD according to McKeith's criteria, or, \n\n FTD according to Neary's or Lund & Manchester criteria or, \n\n PDD according to DSM-IV TR criteria [F02.x] or, \n\n Mixed dementia which is defined in this study as patients fulfilling DSM-IV TR criteria [F02.8] for dementia with multiple aetiologies focussing on dementia of Alzheimer type with secondary occurrence of vascular dementia. \n\n Written informed consent obtained from the patient or, if appropriate, from legal representative according to local laws and regulations. \n\n Evidence that brain imaging (either cerebral CT-scan or cerebral MRI) was performed to settle the diagnosis of dementia, and that the results are compatible with the diagnosis of dementia. \n\n Absence of other signs or symptoms that may be better related to another type of dementia than the current dementia diagnosis. \n\n Patient compliant with study procedures. \n\n Cognitive impairment-free control group : \n\n Male or female subject, aged \u2265 60 years old included at entry. \n\n Written informed consent obtained from the subject. \n\n Absence of spontaneously reported significant cognitive complaints from the subject at entry. \n\n MMSE \u2265 27 at entry. \n\n Subject with no impairment in daily living activities. \n\n Subject compliant with study procedures. \n\n ", + "exclusion_criteria": ": \n\n AD group : \n\n Any pathology, medical condition or symptoms that may lead to reconsider the initial diagnosis of probable AD, or that may rend the initial diagnosis of probable AD doubtful at entry, according to the opinion of the investigator. \n\n Current or recent history of drug or alcohol abuse or dependence. \n\n Diagnostic of Mild Cognitive Impairment defined by subjective complaints from the patient regarding memory and/or cognitive symptoms, objective memory and/or cognitive impairment at testing but not meeting AD diagnostic criteria, and not affecting daily living activities. \n\n Current diagnosis of brain tumour. \n\n Any current pathology or medical condition, for which blood sampling may involve a risk for the patient's health, according to the opinion of the investigator. \n\n Pregnancy. \n\n Patient who is not registered at S\u00e9curit\u00e9 Sociale. \n\n Current participation in another study using an investigational non-marketed product. \n\n Non-AD demented group : \n\n Any pathology, medical condition or symptoms that may lead to reconsider the initial diagnosis of dementia the patient is suffering from, or that may rend the initial diagnosis of dementia doubtful at entry, according to the opinion of the investigator. \n\n Diagnostic of Mild Cognitive Impairment defined by subjective complaints from the patient regarding memory and/or cognitive symptoms, objective memory and/or cognitive impairment at testing but not meeting the diagnostic criteria for dementia, and not affecting daily living activities. \n\n Current diagnosis of brain tumour. \n\n Any current pathology or medical condition for which blood sampling may involve a risk for the patient's health, according to the opinion of the investigator. \n\n Current or recent history of drug or alcohol abuse or dependence. \n\n Pregnancy. \n\n Patient who is not registered at S\u00e9curit\u00e9 Sociale. \n\n Current participation in another study using an investigational non-marketed product. \n\n Cognitive impairment-free control group : \n\n Subject spontaneously complaining from significant cognitive impairment. \n\n Known family history of dementia. \n\n Diagnosis of any type of dementia (either AD or non-AD dementia), Mild Cognitive Impairment, or any current or past history of CNS pathology (including but not limited to brain injury, brain tumour, stroke, normal pressure hydrocephalus, Parkinson's disease, epilepsy, multiple sclerosis,\u2026) that may be responsible for the occurrence of dementia. \n\n History or current clinically significant psychiatric pathology (including but not limited to psychotic disorders, bipolar disorder, personality disorders). \n\n Current major depressive disorder, either treated or not, associated with clinically significant symptoms. \n\n Any current pathology or medical condition for which blood sampling may involve a risk for the subject's health, according to the opinion of the investigator. \n\n Current or recent history (within one month) of clinically significant pathology, medical condition (including hospitalization) or symptoms. However, chronic diseases or medical conditions which are considered stable are accepted, provided that they are compatible with other study selection criteria. \n\n Current or recent history of drug or alcohol abuse or dependence. \n\n Subject who is not registered at S\u00e9curit\u00e9 Sociale. \n\n Current participation in another study using an investigational non-marketed product.", + "brief_summary": "The objective of the study is to define the performance of blood-based signatures for Alzheimer's Disease (AD) in different patients populations including AD, non-AD dementia, and non-demented controls.", + "NCTID": "NCT00880347", + "total_score": 0.2387311692573737, + "bm25_score": 0.10748943768310577, + "medcpt_score": 0.1312417315742679 + }, + { + "nct_id": "NCT00182832", + "brief_title": "e-CHAMP: Enhancing Care for Hospitalized Older Adults With Memory Problems", + "phase": "", + "drugs": "['e-CHAMP (Enhancing Care for Hospitalized Older Adults with Cognitive Impairment)', 'Standard Care']", + "drugs_list": [ + "e-CHAMP (Enhancing Care for Hospitalized Older Adults with Cognitive Impairment)", + "Standard Care" + ], + "diseases": "['Cognitive Impairment', 'Delirium']", + "diseases_list": [ + "Cognitive Impairment", + "Delirium" + ], + "enrollment": "424.0", + "inclusion_criteria": "inclusion criteria: \n\n 65 years of age or older \n\n Hospitalized in a medical ward \n\n Able to speak English \n\n Cognitive impairment based on screening at time of hospital admission \n\n ", + "exclusion_criteria": ": \n\n Previously enrolled in the study during prior hospitalization (for multiple admissions; only data from the first admission will be used) \n\n Enrolled in another clinical trial \n\n Does not have cognitive impairment based on screening at time of hospital admission", + "brief_summary": "The purpose of this study is to evaluate the effectiveness of a cognitive screening program coupled with a computerized decision support system in improving the quality of care for hospitalized older adults with cognitive impairment.", + "NCTID": "NCT00182832", + "total_score": 0.20408913004309812, + "bm25_score": 0.08021714149929206, + "medcpt_score": 0.1238719885438061 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201521", + "patient": "<0.> A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. <1.> Stools are greasy and foul-smelling. <2.> He also has loss of appetite and malaise. <3.> He recently returned home from a hiking trip in the mountains where he drank water from natural sources. <4.> An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. <5.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT02105714", + "brief_title": "Diagnosis of Neglected Tropical Diseases Among Patients With Persistent Digestive Disorders", + "phase": "", + "drugs": "['Stool culturing for pathogenic bacteria', 'Kato-Katz technique', 'Baermann technique', 'Mini-FLOTAC', 'Crypto/Giardia Duo Strip', 'Formalin-ether concentration technique', 'CCA RDT', 'Koga agar plate culture', 'Kinyoun staining', 'Multiplex PCR', 'Metagenomics analysis']", + "drugs_list": [ + "Stool culturing for pathogenic bacteria", + "Kato-Katz technique", + "Baermann technique", + "Mini-FLOTAC", + "Crypto/Giardia Duo Strip", + "Formalin-ether concentration technique", + "CCA RDT", + "Koga agar plate culture", + "Kinyoun staining", + "Multiplex PCR", + "Metagenomics analysis" + ], + "diseases": "['Soil-transmitted Helminthiasis', 'Schistosomiasis', 'Strongyloidiasis', 'Shigellosis', 'Intestinal Salmonellosis', 'Campylobacteriosis', 'Aeromonas Spp. Infections', 'Giardiasis', 'Amoebiasis', 'Dientamoebiasis', 'Cryptosporidium Spp. Infections']", + "diseases_list": [ + "Soil-transmitted Helminthiasis", + "Schistosomiasis", + "Strongyloidiasis", + "Shigellosis", + "Intestinal Salmonellosis", + "Campylobacteriosis", + "Aeromonas Spp. Infections", + "Giardiasis", + "Amoebiasis", + "Dientamoebiasis", + "Cryptosporidium Spp. Infections" + ], + "enrollment": "2800.0", + "inclusion_criteria": "inclusion criteria: \n\n Individuals aged \u22651 year presenting with persistent diarrhoea (\u22653 loose stools per days for \u22652 weeks; symptomatic group) and/or children (aged 1-18 years) with persistent abdominal pain (localized or diffuse abdominal pain lasting for \u22652 weeks, with possible intermittence/recurrence). \n\n Individuals with written informed consent provided. \n\n ", + "exclusion_criteria": ": \n\n Individuals in need of immediate intensive or surgical care. \n\n Individuals who are unable or unwilling to give written informed consent. \n\n Individuals who do not meet the inclusion criteria for being a case or control (e.g. people with acute diarrhoea). \n\n Individuals with clinical jaundice (assessed by direct observation of the conjunctivae). \n\n Individuals who are unable, in the study physician's opinion, to comply with the study requirements. \n\n Individuals who are already participating in other ongoing diagnostic studies and/or clinical trials.", + "brief_summary": "NIDIAG is an international collaboration on integrated diagnosis-treatment platforms, funded by the European Commission (EC). NIDIAG aims to develop an improved, patient-centred system for delivering primary health care in resource-constrained settings. NIDIAG will investigate three clinical syndromes, namely (i) persistent digestive disorders, (ii) persistent fever and (iii) neurological disorders, due to neglected tropical diseases (NTDs). The current study focuses on persistent digestive disorders, which are defined as diarrhoea or abdominal pain that last for at least 2 weeks.~While acute diarrhoea has been studied globally, few research activities have focused on the epidemiology, diagnosis and treatment of long-lasting diarrhoeal episodes (2 weeks and longer) in the tropics. The spectrum of possibly involved pathogens includes more than 30 bacterial, parasitic and viral infectious agents. This lack of data may be explained by the fact that people suffering from NTDs might only seek care at a late stage of the disease. Furthermore, health systems in affected regions are often weak and their primary health-care centres are often under-staffed and lack essential diagnostic equipment.~The hypothesis of this study is that development of an evidence-based syndromic approach can lead to better diagnosis and management of NTDs in patients with persistent digestive disorders. The study will be carried out in two West African countries (C\u00f4te d'Ivoire and Mali) and in two Asian countries (Indonesia and Nepal). The study will follow a case-control design and patients and controls will be prospectively enrolled. In order to address the knowledge gaps, three specific objectives will be pursued. First, the contribution of NTDs to the 'persistent digestive disorders syndrome' will be assessed. Second, the value of clinical features and rapid diagnostic tests (RDTs) for the diagnosis of target NTDs that give rise to persistent digestive disorders will be determined. Third, the clinical response to standard empiric and targeted treatment of several NTDs in patients with persistent digestive disorders will be evaluated. These objectives will provide a long-term benefit for the communities by improving the clinical decision-making process for the target NTDs and thus, better diagnostic work-up and patient management can be achieved in the study countries and other similar resource-constrained countries", + "NCTID": "NCT02105714", + "total_score": 0.22239937693885065, + "bm25_score": 0.09112440191387561, + "medcpt_score": 0.13127497502497504 + }, + { + "nct_id": "NCT01959048", + "brief_title": "Efficacy and Safety of Fecal Microbiota Transplantation for Severe Clostridium Difficile Associated Colitis", + "phase": "", + "drugs": "['fecal microbiota transplantation']", + "drugs_list": [ + "fecal microbiota transplantation" + ], + "diseases": "['Clostridium Difficile']", + "diseases_list": [ + "Clostridium Difficile" + ], + "enrollment": "3.0", + "inclusion_criteria": "inclusion criteria: \n\n Both genders are eligible for study \n\n Age 18 years and older \n\n Able to provide written, informed consent \n\n Confirmed diagnosis of severe CDAD as defined above \n\n ", + "exclusion_criteria": ": \n\n (If any of the following apply, the subject MUST NOT enter the study): \n\n Pregnant or lactating women \n\n Need for prolonged antibiotics for other cause \n\n Other known etiology for diarrhea, or clinical infection with other known enteric pathogens \n\n Active, chronic conditions such as: Inflammatory bowel disease, Crohn's disease, Short bowel syndrome, Ulcerative or ischemic colitis \n\n Laxatives or motility-altering drugs within 12 hours of enrolment \n\n Clinically unstable. Hemodynamic instability defined as hypotension (mean arterial pressure < 60) not responsive to fluids. \n\n Any condition that, in the opinion of the investigator, would preclude safe participation in the trial or compromise the quality of the data obtained. \n\n Immune suppression, HIV, hematological or solid malignancy (chemotherapy in the past 3 months). \n\n Prior colon surgery", + "brief_summary": "Clostridium difficile has become one of the leading causes of hospital acquired infections, and is associated with increased mortality. Patients with C. difficile associated disease (CDAD) possess deficiencies in 'normal' fecal microbial composition, most likely as a result of earlier antibiotic usage. The current standard of care treatment for severe C. difficile, which consists of antibiotics, does not restore the microbiota. Restoration of the normal colonic microbiota by fecal microbiota transplantation (FMT) may enable reversion colonic microbial population to a more 'normal'state and lead to cure.~A few patients develop severe CDAD which may be complicated by adynamic ileus, or toxic megacolon. The management in this context is based on limited data, and for some the only available option is sub-total colectomy.~Although FMT is by no means a new therapeutic modality, there is limited information on its use for the treatment of acute CDAD, including severe CDAD. Because of the high morbidity and mortality associated with treatment of patients with severe CDAD, and because the evidence supporting the current recommendations is weak and based upon the demonstration that FMT is an effective strategy to re-establish a balanced intestinal microbiota with resultant cure of recurrent CDAD, we propose to study the efficacy and safety of FMT for severe CDAD.~Patients with severe CDAD can be divided into two operational groups; those that have diarrhea and those that suffer from adynamic ileus. We propose to apply FMT through colonoscopy for all patients because current data suggest that the overall success rate of FMT for recurrent CDAD with lower gastrointestinal tract FMT was higher than FMT through the upper gastrointestinal tract. In addition, for patients with adynamic ileus and toxic megacolon (i.e., the population with the highest CDAD-associated morbidity and mortality), intra-colonic FMT administration is the preferred alternative.", + "NCTID": "NCT01959048", + "total_score": 0.15972547618873592, + "bm25_score": 0.06282379044984086, + "medcpt_score": 0.09690168573889503 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201522", + "patient": "<0.> A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. <1.> Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. <2.> The spherical mass moved in the cavity during supine and prone CT imaging. <3.> Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. <4.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT02534727", + "brief_title": "Sputum Pharmacokinetics of TB Drugs and Bacterial Drug Resistance", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Tuberculosis', 'Non-Tuberculosis Mycobacteria']", + "diseases_list": [ + "Tuberculosis", + "Non-Tuberculosis Mycobacteria" + ], + "enrollment": "215.0", + "inclusion_criteria": "inclusion criteria: \n\n At least 18 years of age \n\n Diagnosis of TB (and/or NTM for NIH clinical center subjects) \n\n Ongoing signs and/or symptoms of pulmonary TB (and/or NTM at the NIH CC) \n\n Suspected drug resistance (drug susceptible allowed at the NIH CC) \n\n Available to provide at least 3 sputa over 2 or more days \n\n Taking anti-tuberculosis medicines (or NTM meds at NIH CC) during the time sputa are provided \n\n Thought likely to be Mycobacterium culture positive (including NTM infected for the NIH CC) by enrolling physician \n\n GeneXpert MTB/RIF sputum TBpositive (China subjects only) \n\n Likely able to produce sputum samples while on study \n\n Willing to provide blood samples \n\n Willing to have samples stored \n\n ", + "exclusion_criteria": ": \n\n Acute liver or kidney disease \n\n Conditions which compromise the subject s ability to take or absorb oral drugs", + "brief_summary": "Background:~Many people around the world get tuberculosis (TB) and non-tuberculous mycobacteria (NTM) infections. Sometimes medicine that treats these infections does not get to where the bacteria are in the lungs. Researchers want to find a way to tell if enough medicine is getting to where it is needed in the lungs. They will look at how much medicine is in your sputum (what you cough up) compared to how much is in your blood. They will also investigate a new test to quickly figure out what medicines are likely to treat TB effectively.~Objective:~To determine the relationship between the concentration of TB drugs in plasma and sputum over time.~Eligibility:~People ages 18 and older who have TB or NTM infection that is suspected to be drug resistant. They must be taking TB or NTM medicines.~Design:~Participants will be screened with medical history.~Participants will be in the study for 2 8 days.~Participants will give 3 or more sputum samples over at least 2 different days. They will cough sputum into a cup.~Participants will have blood drawn 4 times a day on 2 different days.", + "NCTID": "NCT02534727", + "total_score": 0.14195173018702428, + "bm25_score": 0.06800993124522538, + "medcpt_score": 0.07394179894179893 + }, + { + "nct_id": "NCT01207128", + "brief_title": "Trial of Combination Antifungal Therapy (Vori+Mica vs. Vori+Placebo) in Invasive Aspergillosis", + "phase": "Phase 2", + "drugs": "['Voriconazole, micafungin']", + "drugs_list": [ + "Voriconazole", + "micafungin" + ], + "diseases": "['Aspergillosis']", + "diseases_list": [ + "Aspergillosis" + ], + "enrollment": "0.0", + "inclusion_criteria": "inclusion criteria: \n\n The patient or legally authorized representative has signed an informed consent/assent. \n\n Assent will be obtained as required by the UAMS IRB. \n\n The patient has a diagnosis of proven or probable invasive aspergillosis and with positive Aspergillus GM index (\u22650.5 ng/ml) provide the patient is not receiving antibiotics, such as piperacillin-tazobactam, that are known to cause false positive GMI \n\n The patient is 18 years of age or older. \n\n ", + "exclusion_criteria": ": \n\n The patient is being treated with an unlicensed investigational drug for aspergillosis. \n\n The patient has been administered an antifungal agent (voriconazole, itraconazole, posaconazole, caspofungin, micafungin, anidulafungin, amphotericin B, or lipid formulation of amphotericin B) for > 7 days immediately prior to randomization for treatment of the Probable, or Proven invasive aspergillosis for which the patient is being enrolled. \n\n Patient has invasive aspergillosis but with negative Aspergillus GM index. \n\n The patient is pregnant or lactating. If the patient is female and of childbearing potential, the patient must have a negative pregnancy test and avoid becoming pregnant while receiving study drug. A pregnancy test should be performed within 14 days prior to the first dose of study drug. \n\n The patient has alkaline phosphatase, ALT, AST or total bilirubin greater than five times the upper limit of normal. \n\n The patient has hepatic cirrhosis. \n\n Patients with creatinine > 3 will be enrolled only if able to receive oral voriconazole (specify oral loading dose is 6 mg/kg PO Q 12 hours for 24 hours) then oral maintenance 200 mg PO q 12 hours). \n\n The patient is on artificial ventilation, and unlikely to be extubated within 24 hours of study entry. \n\n The patient has a history of allergy, hypersensitivity, or any serious reaction to the azole or echinocandin class of antifungal agents. \n\n The patient has previously enrolled into this study. \n\n The patient has a concomitant medical condition, which in the opinion of the Investigator may create an unacceptable additional risk. \n\n The patient has an active microbiologically-documented deep infection due to a non-Aspergillus mold. \n\n The patient has a life expectancy of less than seven days.", + "brief_summary": "The purpose of this study is to evaluate the therapeutic effectiveness of combination antifungal therapy (CAT) of voriconazole plus micafungin versus voriconazole plus placebo equivalent as primary therapy for invasive aspergillosis (IA) in patients with hematological cancer.", + "NCTID": "NCT01207128", + "total_score": 0.13471758719436738, + "bm25_score": 0.051102019755270525, + "medcpt_score": 0.08361556743909686 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201523", + "patient": "<0.> An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. <1.> His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia. <2.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT00084240", + "brief_title": "Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine For The Treatment Of Uncomplicated, Symptomatic Falciparum Malaria In Southeast Asia", + "phase": "Phase 2; Phase 3", + "drugs": "['Azithromycin/Chloroquine', 'Sulfadoxine-Pyrimethamine/Chloroquine']", + "drugs_list": [ + "Azithromycin/Chloroquine", + "Sulfadoxine-Pyrimethamine/Chloroquine" + ], + "diseases": "['Malaria, Falciparum']", + "diseases_list": [ + "Malaria", + "Falciparum" + ], + "enrollment": "32.0", + "inclusion_criteria": "inclusion criteria: \n\n Females and males >=18 years of age with uncomplicated, symptomatic malaria as indicated by the presence of both of the following: a.) Blood smears positive for Plasmodium falciparum asexual parasitemia between 1000 -100,000 parasites/mL b.) Fever or history of fever (>= 38.5 C/101.2 F rectal or tympanic; >= 37.5 C/99.5 F axillary or >= 38 C/100.4 F oral) within the prior 24 hours \n\n Serum glucose >= 60 mg/dL (by fingerstick or peripheral blood collection) \n\n Positive rapid diagnostic test (Binax NOW ICT) for P. falciparum \n\n Women of childbearing potential must have a negative urine gonadotropin prior to entry into the study and must agree to use adequate contraception during the entire study \n\n ", + "exclusion_criteria": ": \n\n Severe or complicated malaria including subjects with any of the following: a.) Impaired consciousness, seizures or abnormal neurologic exam b.) Jaundice c.) Respiratory distress d.) Persistent vomiting e.) Hematuria, as reported by the patient f.) Parasite density > 100,000 parasites/mL g.) Presence of non-falciparum species on microscopy \n\n Pregnant or breast-feeding women \n\n History of allergy to or hypersensitivity to azithromycin or any macrolide, sulfonamides, pyrimethamine, or chloroquine \n\n Known history of blood dyscrasias (e.g., megaloblastic anemia, agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia) \n\n History of epilepsy or psoriasis \n\n History of treatment with any antimalarial drug (chloroquine, quinine, mefloquine, Malarone, SP, artemisinin compounds) or antibacterial with known antimalarial activity (macrolides, doxycycline, clindamycin) within 2 weeks prior to enrollment into the study \n\n Known or suspected cardiovascular, hepatic or renal abnormality that in the opinion of the Investigator would place the subject at increased risk to participate in the study. The following findings are specific exclusions: a.) serum creatinine > 2.0 x ULN b.) ALT and/or AST > 3 x ULN \n\n Inability to swallow oral medication in tablet form \n\n Treatment with other investigational drugs within 30 Days prior to enrollment into the study \n\n Alcohol and/or any other drug abuse \n\n Requirement to use medication during the study that might interfere with the evaluation of the study drug (nelfinavir, digoxin, ergot alkaloids, terfenadine, cyclosporine, hexobarbital and phenytoin) \n\n Specific systemic diseases or other medical conditions that would interfere with the evaluation of the therapeutic response or safety of the study drug \n\n Inability to comprehend and/or unwillingness follow the study protocol \n\n Intentions to leave the vicinity of the trial site in the next 42 days \n\n Prior participation in this study", + "brief_summary": "The primary objective is to confirm the hypothesis that azithromycin (optimal dose once daily for three days) plus chloroquine is non-inferior to sulfadoxine-pyrimethamine plus chloroquine for the treatment of uncomplicated, symptomatic malaria due to P. falciparum.", + "NCTID": "NCT00084240", + "total_score": 0.2105367450965194, + "bm25_score": 0.11137471703743257, + "medcpt_score": 0.09916202805908687 + }, + { + "nct_id": "NCT02334514", + "brief_title": "The Effect of Oseltamivir Treatment on the Yield of Polymerase Chain Reaction Test for Confirmed Influenza Infection", + "phase": "", + "drugs": "", + "drugs_list": [], + "diseases": "['Influenza']", + "diseases_list": [ + "Influenza" + ], + "enrollment": "215.0", + "inclusion_criteria": "inclusion criteria: \n\n clinical presentation that suggest influenza virus infection, including sudden onset of high fever, cough, headache, muscle and joint pain, severe malaise, sore throat and runny nose, \n\n positive to influenza virus by PCR test \n\n anti viral treatment was indicated \n\n ", + "exclusion_criteria": ": \n\n Immune compromised patients: patients after solid organ transplant, post bone marrow transplantation, with inherited or acquired immune deficiency, or patients treated chronically with immunosuppressive drugs. \n\n Pregnant women. \n\n Patients who were treated with oseltamivir in the previous 6 months", + "brief_summary": "The purpose of this study is to determine the duration of viral shedding in hospitalized patients with influenza virus, treated with oseltamivir.", + "NCTID": "NCT02334514", + "total_score": 0.18660347009047074, + "bm25_score": 0.08898179773179775, + "medcpt_score": 0.097621672358673 + } + ], + "1": [], + "2": [] + }, + { + "patient_id": "sigir-201524", + "patient": "<0.> A 31 yo male with no significant past medical history presents with productive cough and chest pain. <1.> He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. <2.> He has right-sided chest pain that is aggravated by coughing. <3.> His wife also had cold symptoms a week ago but is now feeling well. <4.> Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. <5.> Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. <6.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues.", + "0": [ + { + "nct_id": "NCT00540072", + "brief_title": "Study of Cidecin\u2122 (Daptomycin) to Rocephin\u00ae (Ceftriaxone) in the Treatment of Moderate to Severe Community-Acquired Acute Bacterial Pneumonia Due to S. Pneumoniae", + "phase": "Phase 3", + "drugs": "['daptomycin']", + "drugs_list": [ + "daptomycin" + ], + "diseases": "['Pneumonia, Bacterial']", + "diseases_list": [ + "Pneumonia", + "Bacterial" + ], + "enrollment": "", + "inclusion_criteria": "inclusion criteria: \n\n Provide signed and dated informed consent. \n\n Adults, 18 years of age or older of either gender and of any race weighing up to 150 kg. Female patients of childbearing potential MUST be nonpregnant (confirmed by negative serum pregnancy test), nonlactating, and must be willing to practice reliable birth control measures during and for at least 30 days after treatment with study drug(s). \n\n Have a new pulmonary infiltrate on chest radiograph. \n\n Exhibit at least two of the following clinical symptoms of pneumonia on history or physical: \n\n Cough \n\n Production of purulent sputum or change in character of sputum \n\n Auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation (dullness to percussion, bronchial breath sounds, or egophony) \n\n Dyspnea or tachypnea \n\n Documented fever, defined as body temperature >38.0 \u00baC (100.4 \u00baF) taken orally; >38.5 \u00baC (101.2 \u00baF) tympanically; or >39.0 \u00baC (102.2 \u00baF) rectally or hypothermia, defined as core body temperature of <35.0 \u00baC (95.0 \u00baF) \n\n An elevated total peripheral white blood cell count (WBC >10,000/mm3); or >15% immature neutrophils (bands), regardless of total peripheral white count; or leukopenia with total WBC <4500/mm3. \n\n Hypoxemia with a PO2 < 60 mmHg (on room air) or O2 saturation <90% on room air \n\n Pneumonia which requires hospitalization and intravenous therapy for at least 5 days. \n\n Willingness to participate in this study and to complete all follow-up assessments. \n\n ", + "exclusion_criteria": ": \n\n Patients with Grade V pneumonia (based on Fine Score; Attachment 8). \n\n Patients in respiratory failure or incipient respiratory failure if the patient is not a candidate for mechanical ventilation (for any reason). \n\n Any of the following pulmonary conditions that may preclude interpretation of study results: \n\n Cystic fibrosis \n\n Primary lung cancer or another malignancy metastatic to the lungs \n\n Known bronchial obstruction or a history of post-obstructive pneumonia \n\n Known or suspected active tuberculosis. \n\n Severe shock (systolic blood pressure <90 mm Hg for >30 minutes not corrected by fluid bolus). \n\n Clinical evidence of bacterial meningitis (based on lumbar puncture results). \n\n Severe renal impairment (calculated creatinine clearance <30 mL/min). \n\n Moribund clinical condition: high likelihood of death during the first 48 hours. \n\n If HIV positive, known CD4 counts <200/mm3 or evidence of Pneumocystis carinii pneumonia. \n\n Inability to tolerate ceftriaxone or history of allergy to beta-lactam antibiotics (history of rash alone will not exclude a patient). \n\n Any individual previously treated with a potentially effective anti-infective agent for > 24 hours (or one dosing day) within 72 hours of enrollment, or prior treatment with any investigational drug (including experimental biologic agents) in previous 30 days or prior therapy with daptomycin. \n\n Patients who must continue HMG-CoA reductase inhibitor therapy (e.g., simvastatin, lovastatin, etc.) during the study treatment period. \n\n Anticipation that a second non-protocol systemic antibiotic will be required. \n\n Induction chemotherapy within 2 weeks prior to enrollment (or exogenous therapies which are anticipated to result in PMN counts of <200 mm3 during Treatment Phase), or patients with severe neutropenia (<200 PMN cells/mm3). \n\n Patients considered unreliable to return for visits or to comply with study procedures. \n\n Progressive neoplastic disease (Note: patients with malignancies in remission are eligible). \n\n Women who are pregnant or nursing/lactating. \n\n Patients presenting with nosocomial pneumonia (i.e., <14 days after discharge from a skilled nursing facility or hospital with an initial hospitalization of >=3 days duration). \n\n Clinical suspicion of Legionella pneumonia.", + "brief_summary": "A COMPARASON OF CIDECIN\u2122 (DAPTOMYCIN) TO ROCEPHIN\u00ae (CEFTRIAXONE) IN THE TREATMENT OF MODERATE TO SEVERE COMMUNITY-ACQUIRED ACUTE BACTERIAL PNEUMONIA DUE TO S. PNEUMONIAE", + "NCTID": "NCT00540072", + "total_score": 0.2125265808858042, + "bm25_score": 0.0981346394938628, + "medcpt_score": 0.1143919413919414 + }, + { + "nct_id": "NCT00711399", + "brief_title": "Assessment of Cough and Wheeze With Breath Sound Documenting Device", + "phase": "", + "drugs": "['PulmoTrack\u00ae 2010 with WIM-PC\u2122 and WIM-CC\u2122 Technologies']", + "drugs_list": [ + "PulmoTrack\u00ae 2010 with WIM-PC\u2122 and WIM-CC\u2122 Technologies" + ], + "diseases": "['Respiratory Sounds']", + "diseases_list": [ + "Respiratory Sounds" + ], + "enrollment": "55.0", + "inclusion_criteria": "inclusion criteria: \n\n Patient and/or parents/guardian signed informed consent \n\n Patients with cough or shortness of breath \n\n ", + "exclusion_criteria": ": \n\n Chest tubes \n\n Skin lesions precluding attachment of sensors \n\n Respiratory distress \n\n Pregnant women", + "brief_summary": "The study goal is to create a database of respiratory sounds recordings, to evaluate and validate the WIM technology and to evaluate the efficacy of a specific treatment by comparing the severity of the respiratory symptoms before and after the administration of the treatment.", + "NCTID": "NCT00711399", + "total_score": 0.16522829022829022, + "bm25_score": 0.072498334998335, + "medcpt_score": 0.09272995522995522 + } + ], + "1": [], + "2": [] + } +] \ No newline at end of file diff --git a/results/trial_rankings/all_rankings.json b/results/trial_rankings/all_rankings.json new file mode 100644 index 0000000..ffcc56a --- /dev/null +++ b/results/trial_rankings/all_rankings.json @@ -0,0 +1,1189 @@ +{ + "sigir-20141": { + "patient_summary": "A 58-year-old African-American woman presents with episodic anterior chest pain radiating to the back, accompanied by nausea, diaphoresis, and mild dyspnea. She has a history of hypertension and obesity but denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. The EKG shows nonspecific changes.", + "trials": { + "NCT00149227": { + "matching_score": 1.0, + "agg_score": 0.8, + "trial_score": 1.8, + "qrels_score": 2, + "brief_summary": "The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients in Japan with hypertension in terms of the morbidity and mortality.", + "relevance_explanation": "The patient is relevant to the clinical trial as she has a clinical diagnosis of hypertension, which is a target condition of the trial. Additionally, she has obesity and ECG abnormalities, which are considered risk factors for the trial. These factors align with the trial's focus on high-risk patients with hypertension.", + "eligibility_explanation": "The patient meets the inclusion criteria due to her hypertension and additional risk factors such as obesity and ECG abnormalities. She is not excluded by any of the exclusion criteria, as there is no evidence of ARB use, recent PCI or CABG, severe hypertension, pregnancy, arrhythmia, or severe renal or hepatic impairment. However, there is insufficient information regarding some exclusion criteria, such as renal and hepatic function, which slightly reduces the eligibility score." + }, + "NCT01397994": { + "matching_score": -0.2, + "agg_score": -0.4, + "trial_score": -0.6, + "qrels_score": 1, + "brief_summary": "This study is to determine the anti-anginal and anti-ischemic effect of k-channel opener, nicorandil in patients of chronic stable angina.", + "relevance_explanation": "The patient presents with episodic chest pain, which is a symptom related to angina, but there is no evidence of chronic stable angina or an abnormal Exercise Myocardial Perfusion Spect Scan, which are key requirements for the trial. The patient is within the age range and is female, which are relevant to the trial's inclusion criteria. However, the lack of a confirmed diagnosis of chronic stable angina significantly reduces the relevance.", + "eligibility_explanation": "The patient meets several inclusion criteria such as age, gender, and willingness to comply with the study protocol. However, the patient does not have a confirmed diagnosis of chronic stable angina, which is a critical inclusion criterion. Additionally, there is insufficient information to confirm or exclude the patient based on some exclusion criteria, such as blood pressure specifics and eligibility for Tc 99m SPECT. Therefore, the patient is not eligible for the trial." + } + } + }, + "sigir-20142": { + "patient_summary": "An 8-year-old male presents with fever, dyspnea, and cough after returning from a vacation in Colorado. He is in respiratory distress with bronchial sounds on the left and bilateral lung infiltrates on chest x-ray. Prior to respiratory symptoms, he experienced loose stools.", + "trials": { + "NCT02618655": { + "matching_score": -0.66667, + "agg_score": 0.2, + "trial_score": -0.46667, + "qrels_score": 0, + "brief_summary": "The study will use several laboratory diagnoses in the diagnosis of patients with fever\uff0cto find out which will be more helpful for making an accurate diagnosis in the early period of Tickborne Diseases.", + "relevance_explanation": "The patient presents with an acute fever and respiratory symptoms, which could potentially be related to a tick-borne disease, making the trial relevant. However, the fever duration is only 2 days, which does not fully align with the trial's focus on fever of unknown origin lasting more than one week. The trial aims to diagnose tick-borne diseases, and the patient's recent travel history and symptoms could be relevant, but the short duration of fever limits the relevance.", + "eligibility_explanation": "The patient meets the inclusion criterion of having a temperature higher than 38\u00b0C. However, he does not meet the criterion of having a fever for more than one week, and there is insufficient information regarding the completion of physical and laboratory examinations after one week. The patient is not excluded based on the available exclusion criteria, as there is no indication of a non-infectious cause or automatic discharge. Overall, the patient partially meets the eligibility criteria but lacks key information for full eligibility." + }, + "NCT00711399": { + "matching_score": -0.0, + "agg_score": -0.9, + "trial_score": -0.9, + "qrels_score": 1, + "brief_summary": "The study goal is to create a database of respiratory sounds recordings, to evaluate and validate the WIM technology and to evaluate the efficacy of a specific treatment by comparing the severity of the respiratory symptoms before and after the administration of the treatment.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as he presents with respiratory sounds, specifically cough and shortness of breath, which are the target conditions of the trial. Additionally, the patient and his guardians are willing to provide informed consent, which is a key inclusion criterion.", + "eligibility_explanation": "While the patient meets the inclusion criteria of having cough and shortness of breath and providing informed consent, he is excluded due to being in respiratory distress, which is an exclusion criterion. Therefore, despite being relevant, he is ineligible for the trial." + } + } + }, + "sigir-20143": { + "patient_summary": "A 58-year-old nonsmoking white female presents with mild exertional dyspnea and occasional cough. Imaging reveals a left lung mass and a solitary mass in the right frontal lobe. She is otherwise asymptomatic and has an unremarkable neurologic examination.", + "trials": { + "NCT02490059": { + "matching_score": 0.0, + "agg_score": 0.0, + "trial_score": 0.0, + "qrels_score": 0, + "brief_summary": "The evaluation of solitary pulmonary nodules (SPN) requires a balance between procedure-related morbidity and diagnostic yield, particularly in areas where tuberculosis is endemic. Data on ultrathin bronchoscopy (UB) for this purpose is limited. In this prospective randomised trial we compared diagnostic yield and adverse events of UB with standard-size bronchoscopy (SB) in a cohort of patients with SPN located beyond the visible range of SB.", + "relevance_explanation": "The patient is relevant to the clinical trial as she has a left lung mass, which could potentially be a solitary pulmonary nodule (SPN), a target condition for the trial. However, the relevance is limited by the lack of confirmation via a CT scan, which is necessary to confirm the presence of a pulmonary nodule. Additionally, there is no information on whether the nodule is non-visible on standard-size bronchoscopy, which is a key aspect of the trial. The patient's willingness to provide informed consent and comply with the trial protocol supports her relevance.", + "eligibility_explanation": "The eligibility of the patient is uncertain due to the lack of specific information confirming the presence of a pulmonary nodule on a CT scan and the visibility status of the nodule on standard-size bronchoscopy. While the patient is not excluded based on the informed consent criterion, the absence of critical inclusion information limits her eligibility. Therefore, the eligibility score reflects this uncertainty." + }, + "NCT01452971": { + "matching_score": 0.0, + "agg_score": 0.0, + "trial_score": 0.0, + "qrels_score": 0, + "brief_summary": "Environmental carcinogens such as polycyclic aromatic hydrocarbons (PAHs) were reviewed as the major risk factors for lung cancer development. In this proposal, the investigators collected fifteen kinds of major PAHs and the investigators would like to perform the following studies:~Study the gene expression and subcellular localization of GNMT in the normal-tumor tissue pairs of lung cancer patients.~Study the associations of the polymorphisms of GNMT in lung cancer patients and the susceptibility to lung cancer;~To assess the allelic loss at GNMT and determined the LOH rate of GNMT in the normal-tumor tissue pairs of lung cancer patients.~Study the associations of the copy number variation (CNV) of GNMT and the susceptibility to lung cancer;~Study the interaction between GNMT and polycyclic aromatic hydrocarbons (PAHs) in lung cancer cell lines.", + "relevance_explanation": "The patient is potentially relevant to the clinical trial as she has a left lung mass, which suggests the possibility of lung cancer. The trial is focused on lung cancer patients, specifically studying the GNMT gene in relation to lung cancer. However, there is no confirmed diagnosis of lung cancer in the patient note, which limits the relevance. The patient's age and ability to comply with the trial protocol are not barriers to participation.", + "eligibility_explanation": "The patient is not confirmed to have lung cancer, which is a key inclusion criterion for the trial. While she is not excluded based on age or the absence of lung cancer, the lack of a confirmed diagnosis means she does not fully meet the inclusion criteria. Therefore, her eligibility is limited by the absence of a definitive lung cancer diagnosis." + } + } + }, + "sigir-20144": { + "patient_summary": "A 2-year-old boy presents with 5 days of high fever, irritability, conjunctivitis, strawberry tongue, inflammation and desquamation of the hands and feet, and cervical lymphadenopathy. He has abdominal tenderness, an enlarged liver, and laboratory findings of elevated alanine aminotransferase, leukocytosis, hypoalbuminemia, elevated C-reactive protein, elevated erythrocyte sedimentation rate, mild anemia, and sterile pyuria. Echocardiogram reveals moderate dilation of the coronary arteries with possible aneurysm.", + "trials": { + "NCT02390596": { + "matching_score": 0.6, + "agg_score": 0.5, + "trial_score": 1.1, + "qrels_score": 2, + "brief_summary": "The study is designed to assess the efficacy and safety of anakinra, an interleukin 1 receptor antagonist, in patients with Kawasaki disease who failed to respond to standard treatment:e.g. one infusion of 2g/kg of intravenous immunoglobulins.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as he presents with Kawasaki Disease, which is the target condition of the trial. The patient exhibits the necessary clinical signs and symptoms, including fever for 5 days and 4 out of 5 main clinical signs, as well as coronary artery abnormalities, which align with the trial's inclusion criteria for Kawasaki Disease.", + "eligibility_explanation": "The patient meets several inclusion criteria: he is above the age and weight threshold, has Kawasaki Disease with the required clinical signs, and informed consent is available. However, there is insufficient information regarding the patient's response to standard therapy, health insurance status, and several exclusion criteria such as previous biotherapy treatment, immunodeficiency, and TB risk factors. These unknowns prevent a full eligibility determination." + }, + "NCT00841789": { + "matching_score": -0.0, + "agg_score": -0.5, + "trial_score": -0.5, + "qrels_score": 1, + "brief_summary": "The purpose of this study is to determine whether Etanercept (Enbrel) when used in conjunction with IVIG and aspirin, improves treatment response to IVIG in patients with Kawasaki Disease. Funding Source- FDA/OOPD", + "relevance_explanation": "The patient is highly relevant to the clinical trial as he is a 2-year-old male presenting with symptoms consistent with Kawasaki Disease, which is the target condition of the trial. The trial aims to study the effects of Etanercept in conjunction with IVIG and aspirin in patients with Kawasaki Disease, directly aligning with the patient's condition.", + "eligibility_explanation": "The patient meets all inclusion criteria: he is within the age range, parental consent is provided, and he presents with Kawasaki Disease. However, he is excluded due to laboratory toxicities, specifically elevated alanine aminotransferase and low albumin levels, which may preclude participation. Additionally, the enlarged liver and elevated liver enzymes suggest potential liver issues, further supporting exclusion under criterion 16. These factors significantly impact his eligibility." + } + } + }, + "sigir-20145": { + "patient_summary": "A 56-year-old female, 20 days post-left mastectomy, presents with shortness of breath and malaise. She has been bedridden for two weeks. Physical examination shows tenderness on the left upper thoracic wall and right calf, with decreased breath sounds bilaterally, especially at the right base. Elevated D-dimer is noted.", + "trials": { + "NCT00163709": { + "matching_score": 0.0, + "agg_score": 0.6, + "trial_score": 0.6, + "qrels_score": 2, + "brief_summary": "A trial to examine whether a new heart failure blood test can improve the outcome of patients presenting to the Emergency Department with shortness of breath.~We hypothesise that a BNP test performed in real-time in patients presenting to the Emergency Department with shortness of breath will help identify additional patients with CHF and consequently to change practice and allow more patients to recieve correct treatment earlier.", + "relevance_explanation": "The patient is relevant to the clinical trial as she presents to the emergency department with shortness of breath, which is a primary condition of interest for the trial. Additionally, she is over 40 years old, which aligns with the inclusion criteria. However, there is no information about her triage category, which is necessary to fully assess relevance.", + "eligibility_explanation": "The patient meets the age and symptom criteria for inclusion, as she is over 40 and presents with shortness of breath. There is no evidence of exclusion criteria such as traumatic dyspnea, severe renal disease, cardiogenic shock, or early transfer to another hospital. However, the lack of information about the triage category prevents full confirmation of eligibility." + }, + "NCT01935141": { + "matching_score": 0.0, + "agg_score": 0.3, + "trial_score": 0.3, + "qrels_score": 0, + "brief_summary": "With the improvement in CT scanners and injectors, diagnostic chest CT can now be performed in less than 10 seconds. It was hypothesized that diagnostic CT pulmonary angiograms could be done with less than the usual 80-120 ml of contrast used. We have developed a method of performing diagnostic CT pulmonary angiograms with 30 ml of intravenous contrast in most patients. The long-term objective of this study is to show that there is no difference in the diagnostic efficacy of this low dose 30 ml technique when compared to the more traditional full-dose technique.", + "relevance_explanation": "The patient presents with symptoms suggestive of a pulmonary embolism, such as shortness of breath and an elevated D-dimer, which are relevant to the trial's focus on detecting emboli using CT pulmonary angiography. However, there is no explicit mention of a referral for a CT pulmonary angiogram, which is a key inclusion criterion for the trial.", + "eligibility_explanation": "The patient does not have any exclusion criteria such as congestive heart failure, supraventricular tachycardia, or a history of contrast allergy. The patient is also able to provide informed consent. However, there is insufficient information regarding a referral for a CT pulmonary angiogram and serum creatinine levels, which are necessary to fully determine eligibility." + } + } + }, + "sigir-20146": { + "patient_summary": "The patient is a 64-year-old obese female with Type 2 Diabetes and persistently elevated HbA1c levels. She is non-compliant with her diabetes management, including medication and exercise, and is reluctant to seek nutritional advice. She has a painful, enlarging, and oozing skin lesion on her left lower leg that has not responded to topical treatments.", + "trials": { + "NCT02512159": { + "matching_score": 0.5, + "agg_score": 0.5, + "trial_score": 1.0, + "qrels_score": 2, + "brief_summary": "The aim of this study was to evaluate the efficacy of a handicraft topical device of negative pressure versus traditional healing treatment for skin ulcers in lower limbs; in patients with diabetes mellitus, venous stasis and arterial insufficiency.", + "relevance_explanation": "The patient is relevant to the clinical trial as she has a skin lesion on the lower leg, which could potentially be a type of ulcer targeted by the trial. Additionally, she has diabetes mellitus, a comorbidity associated with the trial's target conditions. However, there is no direct evidence that the lesion is due to diabetes mellitus, venous stasis, or arterial insufficiency, which slightly reduces the relevance.", + "eligibility_explanation": "The patient meets several inclusion criteria: she is over 18 years old and has diabetes mellitus. She is not excluded by any of the exclusion criteria, as there is no evidence of hemodynamic instability, septic shock, deep ulcers with exposed organs, or other specified conditions. However, there is insufficient information to confirm the presence of basic laboratory tests at admission, and the nature of the skin lesion is not fully clarified to confirm it as an ulcer due to the specified conditions. Therefore, while she is likely eligible, the lack of specific information about the lesion's etiology and laboratory tests slightly reduces the eligibility score." + }, + "NCT00015626": { + "matching_score": -0.75, + "agg_score": -0.75, + "trial_score": -1.5, + "qrels_score": 1, + "brief_summary": "The goal of this study is to aggressively treat insulin resistance and its clinical manifestations when they first appear in childhood, and to prevent the subsequent progression towards impaired glucose tolerance and type-2 diabetes. In the process of this clinical trial, we will learn more about the early manifestations of insulin resistance, its treatment, and its relationship to obesity and type-2 diabetes through parallel in-vivo and in-vitro studies.", + "relevance_explanation": "The patient is relevant to the clinical trial as she is obese and has diabetes mellitus, which are target conditions of the trial. The trial aims to address insulin resistance and its complications, which are related to the patient's condition.", + "eligibility_explanation": "The patient meets the inclusion criterion for obesity, but there is insufficient information regarding other inclusion criteria such as specific complications of insulin resistance or family history of type II diabetes. The patient is excluded due to a history of poor compliance with physician's recommendations, which is a significant exclusion criterion." + } + } + }, + "sigir-20147": { + "patient_summary": "The patient is a 26-year-old obese woman with a history of bipolar disorder, experiencing depression, anxiety, and agitation. She reports difficulty sleeping, suicidal thoughts, and increased irritability. Her current medications include lithium carbonate and zolpidem.", + "trials": { + "NCT00845988": { + "matching_score": 0.5, + "agg_score": 0.4, + "trial_score": 0.9, + "qrels_score": 2, + "brief_summary": "The primary goal of this study is to investigate metabolic changes and maintaining efficacy in stabilized patients with bipolar disorders who have pharmacologically induced weight gain.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as she has a history of bipolar disorder, which is the primary condition being studied. Additionally, she is within the age range specified by the trial. The trial aims to study metabolic complications, and the patient is obese, which may indicate metabolic issues. However, there is no specific information about weight gain after starting her current medication, which slightly reduces relevance.", + "eligibility_explanation": "The patient meets the inclusion criteria for having bipolar disorder and being within the age range. She is willing to provide informed consent, but there is no information about her syndromal remission state, which is necessary for full eligibility. Additionally, while she is obese, there is no specific evidence of weight gain after starting her current medication, which is a key inclusion criterion. She does not meet any exclusion criteria, as there is no mention of eating disorders, substance abuse, psychotic disorders, or other medical illnesses. Overall, the lack of information on weight gain and syndromal remission state limits her eligibility." + }, + "NCT01863628": { + "matching_score": -1.0, + "agg_score": -0.5, + "trial_score": -1.5, + "qrels_score": 1, + "brief_summary": "Background and study hypothesis:~Many studies including prospective studies have been demonstrated that a long symptomatic prodromal phase exists prior to the onset of full-brown bipolar disorder, lasting for 9-12 years (Egeland et al., 2000). During the prodromal stage, there are three main clusters of syndromes, including hypomania/mania symptoms, depressive symptoms, and signs of attention deficit hyperactivity disorders (Correll et al., 2007; Tillman et al., 2003; Mantere et al., 2008). Of the hypomania/mania symptoms, decreased sleep, elevated mood, irritability, mood lability, increased energy, and psychomotor agitation are present most frequently. The prodromal depressive symptoms are reported to be depressed mood, anhedonia, insomnia, feelings of worthlessness. Among patients with bipolar disorders, 22.5% reported to comorbid with pediatric ADHD. In addition, some symptoms are considered as non-specific such as decreased functioning, anger outburst, social isolation, and anxiety (Egeland et al., 2000).~Offspring of parents with bipolar disorders are much likely to present prodromal symptoms compared to offspring of healthy parents. In a 10-year longitudinal study using 55 prodromal symptoms checklist, , Egeland et al.(2002) found that 38% offspring of parents with bipolar disorder were considered as at risk compared to 17% in children of healthy parents. In a 15-year follow-up study, Duffy et al.,(2009) found that 32.7% offspring (aged 8-25 years old) of parents with bipolar disorder met the criteria of major mood episode.~Objectives:~One primary objective of this study is to prospectively identify the prodromal stage of bipolar disorder.~Another primary objective is to conduct a randomized, place-controlled trial of aerobic exercise on people who suffering from prodromal symptoms to the extent of significantly impaired function, with attempt at delaying or preventing the onset of a full-blown bipolar disorder.~Design of study and the procedures:~The study will consist of two phases: one-week screening period and a randomized, placebo-controlled, 3-month trial. During the screening period, offspring of parents with bipolar disorder will undergo systematically clinical evaluations. The offspring will be evaluated with clinical symptoms assessing scales, neuropsychological tests, magnetic resonance imaging. During the 3-month trial period, the offspring who meet the inclusion criteria will be randomly assigned to receive treatment of aerobic exercise, placebo, or wait-list group. Psychiatrists are scheduled to assess mood, treatment outcome during the 3-month trial.~Subjects and treatment It is expected that 120 offspring of parents with bipolar disorder aged between 10-25 years, meeting the inclusion of prodromal stage, will be included in the study. All of the offspring will undertake the Kiddie Sads Present and Lifetime Version (K-SADS-PL), and a 70 checklist items of potential prodromal symptoms suggest by us as well as by Dr. Correll et al. (2007). The parents of these offspring are to have a DSM-IV (Diagnostic and Statistical Manual of Mental Disorders)-defined bipolar disorder (bipolar I or II), confirmed by the Chinese version of Structured Clinical interview for DSM-IV-TR Axis I Disorders patient edition (SCID-I/P) [First et al., 2002]. The offspring are to be recruited through the referrals by their parents who will receive psychiatric services in the Guangzhou psychiatric Hospital.~The offspring will be randomly assigned to aerobic exercise and placebo controlled groups. The aerobic exercise would include cycling, jogging,table tennis, and playing badminton for 40 mins at least 3 times a week for 3 months. In each exercise, participants are supposed to exercise to the extent of getting sweaty. In the placebo group, participants will receive general psychoeducation, including delivering knowledge on symptoms, discussion of the suffering mental difficulties, and general coping techniques.~Significance:~Bipolar disorder is a common, chronic, and recurrent mental disorder. The recognition of prodromal stage of bipolar disorder and the early intervention on it may help delay or prevent the onset of bipolar disorder.", + "relevance_explanation": "The patient is relevant to the clinical trial as she has a diagnosis of bipolar disorder, which is the target condition of the trial. However, the trial specifically targets offspring of parents with bipolar disorder, and there is no information provided about the patient's parental history of bipolar disorder. Additionally, the trial focuses on the prodromal stage of bipolar disorder, and while the patient exhibits symptoms such as depressive mood, anxiety, and agitation, there is no information on whether these symptoms are part of a prodromal phase or the duration of these symptoms.", + "eligibility_explanation": "The patient is ineligible for the trial due to the exclusion criterion of having a DSM-IV defined Axis I disorder, which includes her diagnosis of bipolar disorder. While she exhibits symptoms that could be relevant to the trial's focus on prodromal symptoms, the lack of information about her parental history of bipolar disorder and the exclusion due to her current diagnosis significantly impact her eligibility." + } + } + }, + "sigir-20148": { + "patient_summary": "The patient is a 62-year-old man experiencing progressive memory loss and jerking movements of the lower extremities. Neurologic examination reveals severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves, and neuroimaging indicates moderately advanced cerebral atrophy. A cortical biopsy reveals diffuse vacuolar changes of the gray matter with reactive astrocytosis.", + "trials": { + "NCT01519271": { + "matching_score": -0.66667, + "agg_score": -0.2, + "trial_score": -0.86667, + "qrels_score": 1, + "brief_summary": "Mild cognitive impairment, including difficulty with solving problems, planning, attention, or recalling information, can be a significant problem for individuals with Parkinson's disease. Even mild cognitive difficulties can lead to worse functioning, quality of life, depression, and difficulty for caregivers. Thus, ideally treatment at this stage would improve both cognitive symptoms and some of the other problems associated with these symptoms.~Despite the fact that mild cognitive impairment is a serious problem for Parkinson's disease patients little is known about how best to treat it. This study is a 24-week clinical trial to see if a Food and Drug Administration (FDA)-approved drug, the Exelon (rivastigmine) Patch, is useful in treating mild cognitive impairment in patients with Parkinson's disease. Currently, the Exelon (rivastigmine) Patch is FDA-approved for the treatment of mild to moderate dementia in Alzheimer and Parkinson's disease patients.", + "relevance_explanation": "The patient is experiencing severe cognitive deficits and memory dysfunction, which are more advanced than the mild cognitive impairment targeted by the trial. The trial is specifically for patients with mild cognitive impairment in the context of Parkinson's Disease, and there is no mention of Parkinson's Disease in the patient's note. Therefore, the relevance of this patient to the trial is low.", + "eligibility_explanation": "The patient is excluded from the trial due to a likely diagnosis of dementia, as indicated by severe cognitive deficits and memory dysfunction. This directly conflicts with exclusion criterion 3. While the patient can provide informed consent, which meets one inclusion criterion, the presence of dementia makes the patient ineligible for the trial." + }, + "NCT01628315": { + "matching_score": -1.0, + "agg_score": 0.0, + "trial_score": -1.0, + "qrels_score": 1, + "brief_summary": "To examine short- and long-term value of appearance of new active lesions in predicting extent of cortical and subcortical deep gray matter (SDGM) atrophy over 5 years in ASA (Avonex- Steroid-Azathioprine)study.~To explore how accumulation of cortical and SDGM atrophy over 5 years differs with respect to the number of new active lesions or amount of disease activity, in early relapsing-remitting multiple sclerosis (RRMS) patients who did or did not develop sustained disability progression.~To examine the relationship between development of cortical and SDGM atrophy and regional likelihood of development of new active lesions over 5 years.", + "relevance_explanation": "The patient is not relevant to the clinical trial as the trial is focused on patients with relapsing-remitting multiple sclerosis (RRMS), while the patient exhibits symptoms consistent with a neurodegenerative condition, possibly Creutzfeldt-Jakob disease, given the EEG findings and biopsy results. There is no mention of multiple sclerosis or related symptoms in the patient note.", + "eligibility_explanation": "The patient is not eligible for the trial as they do not meet the primary condition of having relapsing-remitting multiple sclerosis, nor is there any indication of prior enrollment in the ASA study or MRI data as required by the trial criteria." + } + } + }, + "sigir-20149": { + "patient_summary": "The patient is a 43-year-old woman presenting with multiple lesions on her neck. The lesions are small, soft, and pedunculated, with the largest being 4 mm in diameter. The color of the lesions ranges from flesh-colored to slightly hyperpigmented.", + "trials": { + "NCT01950026": { + "matching_score": 0.0, + "agg_score": 0.0, + "trial_score": 0.0, + "qrels_score": 0, + "brief_summary": "The aim of this study was to reheat the skin in different ethnic groups after application of cryotherapy.", + "relevance_explanation": "The patient is potentially relevant to the clinical trial as she is visiting a dermatologist for skin lesions, which may involve skin sensitivity or conditions that could be relevant to a study on skin temperature changes after cryotherapy. However, the trial specifically targets body temperature changes in different ethnic groups, and there is no information about the patient's ethnic background in the note.", + "eligibility_explanation": "The patient note does not provide information about the patient's ethnic group, which is necessary for inclusion. However, there is no indication of any exclusion criteria being met, such as changes in skin sensitivity or infectious diseases. Therefore, the patient is not excluded but also not confirmed eligible due to lack of information on the inclusion criterion." + }, + "NCT02615912": { + "matching_score": -1.0, + "agg_score": -0.6, + "trial_score": -1.6, + "qrels_score": 1, + "brief_summary": "The purpose of this study is to understand the changes in skin microflora, skin barrier function, and skin biochemical constituents in response to direct contact with model surfactants used in personal care articles. The results from this study will provide insights into the complex interaction between the skin microbiome and the epidermis after exposure to surfactants.", + "relevance_explanation": "The patient is relevant to the clinical trial as she is visiting a dermatologist for skin lesions, which could be related to skin conditions like dermatitis. The trial aims to study skin microflora dynamics in response to surfactants, which could be relevant to understanding skin conditions. However, the trial specifically targets dermatitis, and the patient note does not explicitly mention dermatitis, which slightly reduces relevance.", + "eligibility_explanation": "The patient is ineligible for the trial due to the exclusion criterion that disqualifies subjects with visible skin conditions. The patient has multiple lesions on her neck, which are considered a visible skin condition, thus excluding her from participation." + } + } + }, + "sigir-201410": { + "patient_summary": "The patient is a 67-year-old woman who underwent cardiac catheterization via the right femoral artery. She is experiencing a cool right foot, a pulsatile mass in the right groin, and loss of distal pulses. A bruit is heard over the entry point of the right femoral artery.", + "trials": { + "NCT02097186": { + "matching_score": 0.33333, + "agg_score": 0.05, + "trial_score": 0.38333, + "qrels_score": 0, + "brief_summary": "Major vascular surgery involves operations to repair swollen blood vessels, clear debris from blocked arteries or bypass blocked blood vessels. Patients with these problems are a high-risk surgical group as they have generalized blood vessel disease. These puts them at risk of major complications around the time of surgery such as heart attacks , strokes and death. The mortality following repair of a swollen main artery in the abdomen is about 1 in 20. This contrasts poorly with the 1 per 100 risk of death following a heart bypass. Simple and cost-effective methods are needed to reduce the risks of major vascular surgery. Remote ischaemic preconditioning (RIPC) may be such a technique. To induce RIPC, the blood supply to muscle in the patient's arm is interrupted for about 5 minutes. It is then restored for a further five minutes. This cycle is repeated three more times. The blood supply is interrupted simply by inflating a blood pressure cuff to maximum pressure. This repeated brief interruption of the muscular blood supply sends signals to critical organs such as the brain and heart, which are rendered temporarily resistant to damage from reduced blood supply. Several small randomized clinical trials in patients undergoing different types of major vascular surgery have demonstrated a potential benefit. This large, multi-centre trial aims to determine whether RIPC can reduce complications in routine practice.", + "relevance_explanation": "The patient underwent cardiac catheterization, which is a vascular procedure, but there is no indication that she is undergoing any of the specific surgeries targeted by the trial, such as carotid endarterectomy, abdominal aortic aneurysm repair, or lower limb revascularization. Therefore, the relevance to the trial is limited.", + "eligibility_explanation": "The patient meets the basic inclusion criteria of age and willingness to provide informed consent. However, there is no information indicating that she is undergoing any of the specific surgeries required for inclusion in the trial. Additionally, there is insufficient information to determine if any exclusion criteria apply. Thus, the eligibility is low." + }, + "NCT02264964": { + "matching_score": 0.25, + "agg_score": 0.05, + "trial_score": 0.3, + "qrels_score": 0, + "brief_summary": "The duration and adverse events of non-cuffed catheter in patients with hemodialysis will be investigated by multicenter prospective cohort. Totally, 1,400 patients with chronic renal failure requiring hemodialysis will be enrolled. 900 patients will be given right internal jugular catheterization, and the other 500 patients unsuitable for right internal jugular catheterization will receive femoral catheterizations. Every patient will be followed-up for six months. During following-up period, the duration time and adverse events of non-cuffed catheter will be recorded in details, including inadequate hemodialysis blood flow, venous stenosis, venous thrombosis, infection, catheter thrombosis and so on. The central vein will be evaluated by CT Angiography to identify its stenosis at last visit after 6 months. This multicentre trial will provide evidence to develop guideline for duration time of using non-cuffed catheter.", + "relevance_explanation": "The patient underwent cardiac catheterization via the right femoral artery, which is not directly related to the trial's focus on central venous catheterization for hemodialysis. The trial targets patients with chronic renal failure requiring hemodialysis, a condition not mentioned in the patient note. However, the patient is willing to provide informed consent, which is relevant to the trial's requirements.", + "eligibility_explanation": "The patient meets the criterion of providing informed consent. However, there is no information indicating that the patient has chronic renal failure requiring hemodialysis, which is a primary inclusion criterion. Additionally, there is no evidence of the patient having undergone central venous catheterization, which is relevant for both inclusion and exclusion criteria. Therefore, the eligibility is limited due to the lack of information on key criteria." + } + } + }, + "sigir-201411": { + "patient_summary": "A 40-year-old woman with no past medical history presents with severe right arm pain, tachypnea, tachycardia, and hypotension. She denies any trauma, and her right arm shows no discoloration or movement limitation. She is pale and in moderate discomfort.", + "trials": { + "NCT01723137": { + "matching_score": 1.0, + "agg_score": 0.95, + "trial_score": 1.95, + "qrels_score": 2, + "brief_summary": "Patient reported pain, stress, and anxiety measures have been found to be inter-related, but it is not known if they are all associated with receiving opiate medications. The objective of this study is to determine if patients' degree of reported pain, stress, or anxiety is associated with receiving opiate pain medications in the emergency department or at discharge. Alert patients at least 18 years of age and who report pain greater than 3/10 are eligible to participate in the study. Consenting patients complete Visual Analog Scales describing their perceived pain, stress, and anxiety from enrollment until discharge. Demographic data and administration of pain medication is also recorded. Visual Analog Scale scores among patients who received an opioid pain medicine in the emergency department and at discharge will be compared to those who did not.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as she presents with acute pain, which is the target condition of the study. The trial aims to measure changes in acute pain using patient-reported scales, and the patient reports excruciating pain, which is likely to be greater than 3 out of 10 on the pain scale. Additionally, the patient is alert, over 18 years of age, and able to provide informed consent, aligning with the trial's inclusion criteria.", + "eligibility_explanation": "The patient meets the inclusion criterion of reporting pain greater than or equal to 3 out of 10, as she presents with excruciating pain. She is 40 years old, which satisfies the age requirement of being at least 18 years old. The patient is alert and able to provide informed consent, which means she does not meet the exclusion criteria of decreased level of consciousness or inability to answer questions. There is no information suggesting she is a prisoner, so she is not excluded on that basis. Therefore, the patient is fully eligible for the trial." + }, + "NCT01526382": { + "matching_score": 0.2, + "agg_score": 0.2, + "trial_score": 0.4, + "qrels_score": 0, + "brief_summary": "PiCCO has been widely used in critical care settings for several decades. Together with pulmonary artery catheter, it is regarded as the important tool for guiding fluid management in patients with shock or acute respiratory distress syndrome. However, its effects on patients' outcome remain untested. The investigators study is a pilot study that is designed to test whether the use of PiCCO will improve patients' outcome, as compared to those without PiCCO monitoring.", + "relevance_explanation": "The patient presents with symptoms that may suggest shock, such as hypotension and tachycardia, which are relevant to the trial's focus on septic shock. However, there is no direct diagnosis of shock or ARDS, which are the primary conditions targeted by the trial. The patient's symptoms align with some of the inclusion criteria, such as tachycardia and tachypnea, but the lack of a confirmed diagnosis of shock or ARDS limits the relevance.", + "eligibility_explanation": "The patient meets some inclusion criteria, such as having a heart rate over 90/min and a respiratory rate over 20/min, which are indicative of potential shock. However, there is insufficient information to confirm other critical criteria, such as the use of vasopressors, signs of hypoperfusion, or a confirmed diagnosis of ARDS. The patient is not excluded based on the available exclusion criteria, but the lack of comprehensive data on key inclusion criteria limits eligibility." + } + } + }, + "sigir-201412": { + "patient_summary": "A 25-year-old woman presents with prolonged fatigue, hair loss, voice changes, weight gain, and cold intolerance over the past 6 months. She has a prominent, soft, uniform anterior cervical mass at the midline. She denies difficulty sleeping and sleeps an average of 8 hours a night.", + "trials": { + "NCT01551498": { + "matching_score": 0.33333, + "agg_score": 0.0, + "trial_score": 0.33333, + "qrels_score": 0, + "brief_summary": "This is a study to evaluate the safety, tolerability, and potential effects of Anatabloc dietary supplementation on antithyroid autoantibodies, thyroid structure, and thyroid function in subjects with autoimmune thyroiditis.", + "relevance_explanation": "The patient presents with symptoms suggestive of thyroid dysfunction, such as fatigue, hair loss, voice change, weight gain, and cold intolerance, along with a cervical mass, which could indicate thyroiditis. These symptoms align with the target condition of autoimmune thyroiditis being studied in the trial. However, there is no direct evidence of autoimmune thyroiditis, such as positive thyroid peroxidase antibodies or sonographic evidence, which are key inclusion criteria.", + "eligibility_explanation": "The patient meets the age criterion and does not have any known exclusions such as end-stage thyroiditis or use of prohibited medications. However, there is insufficient information regarding the presence of thyroid peroxidase antibodies and sonographic evidence of Hashimoto's thyroiditis, which are necessary for inclusion. Without this information, the patient's eligibility remains uncertain." + }, + "NCT00271427": { + "matching_score": -1.0, + "agg_score": -0.5, + "trial_score": -1.5, + "qrels_score": 1, + "brief_summary": "Selenium suppresses autoimmune destruction of thyrocytes and decreases titers of serum TPOAb in AIT patients. Older 4 clinical trials approved the efficacy of the daily dose of 200micg. It's believed that Se saturates the deficient stores of GPX so GPX saves the thyrocytes against to oxidative stresses. Although less than 70 micg/d is sufficient to maximize GPX activity, none of the authors tested the doses less than 200 micg/d. Our hypothesis was that If 100 micg/d can not suppress the TPOAb titers,it means autoimmune destruction can not be blocked by saturation of deficient stores of GPX solely and the mechanism of action requires more than repletion of deficient stores. It's important not only to estimate the optimal dose but to understand the mechanism of action. High dose therapy may also suppress TPOAb levels in Se-non-deficient AIT patients, if it is so, Se therapy may becomes the solely treatment modality which can suppress the autoimmunity in more than 400 million AIT patients. Because there've been no way to suppress autoimmune war and replacement of LT4 had been the only treatment modality for palliation. An other independent part of the study is to test the effect of Se in adolescent AIT patients.", + "relevance_explanation": "The patient presents with symptoms that are consistent with thyroid issues, such as fatigue, hair loss, weight gain, and a cervical mass, which could suggest a thyroid disorder like autoimmune thyroiditis. However, there is no direct evidence in the patient note of a clinical diagnosis of autoimmune thyroiditis or Hashimoto's Thyroiditis, nor is there mention of the patient using LT4, which is a key inclusion criterion for the trial. Therefore, while the symptoms suggest potential relevance, the lack of a confirmed diagnosis and LT4 use limits the relevance to the trial.", + "eligibility_explanation": "The patient does not meet the inclusion criterion as there is no confirmed diagnosis of autoimmune thyroiditis or use of LT4 mentioned in the patient note. Additionally, there is no information provided that would exclude the patient based on the exclusion criteria, such as the use of other medications or known pathologies affecting GIS absorption. However, the lack of a confirmed diagnosis and LT4 use makes the patient ineligible for the trial." + } + } + }, + "sigir-201413": { + "patient_summary": "A 30-year-old woman with a recent childbirth presents with acute shortness of breath, tachypnea, and tachycardia. She has a history of two natural abortions but no other significant past health issues. Her vital signs show mild hypoxemia with an oxygen saturation of 92%, but her chest x-ray and CBC are normal.", + "trials": { + "NCT02264769": { + "matching_score": -0.33333, + "agg_score": 0.1, + "trial_score": -0.23333, + "qrels_score": 0, + "brief_summary": "PostPartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly used uterotonic drug to prevent and treat PPH in North America. However oxytocin has a very short duration of action, requiring a continuous infusion to achieve sustained uterotonic activity. Moreover large doses are associated with adverse effects like hypotension, nausea, vomiting, dysrhythmias and ST changes. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recommended a single dose of 100 mcg of carbetocin at elective cesarean delivery to promote uterine contraction. In three studies recently performed at Mount Sinai Hospital, the investigators have found no difference in uterine contractility between the doses of 20- 120 mcg carbetocin and that the ED90 is 14.8 mcg. Thus a larger trial comparing the minimum effective dose determined in the previous three trials with the standard 100 mcg dose is necessary to confirm these findings.", + "relevance_explanation": "The patient is a postpartum woman, which is relevant to the trial's focus on postpartum hemorrhage. However, the trial specifically targets women undergoing elective cesarean delivery, and this patient had a natural birth. Therefore, while she is somewhat relevant due to the postpartum context, she does not meet the primary inclusion criterion of having an elective cesarean delivery.", + "eligibility_explanation": "The patient meets the inclusion criteria for providing informed consent and having a term pregnancy. However, she does not meet the primary inclusion criterion of having undergone an elective cesarean delivery, which is crucial for this trial. There are no exclusion criteria that apply to her, but the lack of meeting the primary inclusion criterion significantly impacts her eligibility." + }, + "NCT00163709": { + "matching_score": -1.0, + "agg_score": -0.3, + "trial_score": -1.3, + "qrels_score": 1, + "brief_summary": "A trial to examine whether a new heart failure blood test can improve the outcome of patients presenting to the Emergency Department with shortness of breath.~We hypothesise that a BNP test performed in real-time in patients presenting to the Emergency Department with shortness of breath will help identify additional patients with CHF and consequently to change practice and allow more patients to recieve correct treatment earlier.", + "relevance_explanation": "The patient presented to the Emergency Department with shortness of breath, which is the primary condition of interest for the trial. However, the trial specifically targets patients over 40 years old, and the patient is only 30 years old. This significantly reduces the relevance of the trial to the patient.", + "eligibility_explanation": "The patient does not meet the inclusion criterion of being over 40 years old, which makes her ineligible for the trial. There are no exclusion criteria that apply to her, but the failure to meet the age requirement is sufficient to determine ineligibility." + } + } + }, + "sigir-201414": { + "patient_summary": "An 85-year-old man presents with a gradual decrease in consciousness over the past few days, accompanied by a loss of ability to walk and eat independently. He has no fever, cough, rash, or diarrhea. He was involved in a car accident three weeks ago, but a head CT at that time was normal.", + "trials": { + "NCT01624545": { + "matching_score": -0.33333, + "agg_score": -0.4, + "trial_score": -0.73333, + "qrels_score": 1, + "brief_summary": "Chronic subdural hematoma (CSH) is one of the most common bleedings of the head. These hematomas develop after minor head trauma and increase in size over weeks. Patients usually present with headaches, gait disturbances, language problems or confusion. The state of the art treatment of a symptomatic chronic subdural hematoma is to remove the hematoma by burr hole trepanation.~The optimal follow-up for operated patients remains controversial. Due to the known high rate of a second hematoma at the same place (usually within weeks), one strategy is to perform serial computer tomography scans in order to identify recurrent hematomas early. The radiologic evidence of a second hematoma often leads to reoperation, even if the patient has no, or just slight symptoms. Another strategy after surgical hematoma evacuation is to closely follow the patient with neurological examinations and perform neuroimaging only in case of new symptoms. Advocators of this strategy argue that a follow-up with routine CT scans may be harmful due to additional and maybe unnecessary surgeries and hospital days in a patient population marked by advanced age and fragility.~The aim of the current study is to evaluate the role of computer tomography scanning in the postoperative follow-up after removal of a chronic subdural hematoma. Participants of this study will be allocated by chance to one of two study groups: Patients allocated to group A will receive a computer tomography scan on day 2 and again on day 30 after surgery in addition to a clinical examination. Patients allocated to group B will be examined clinically on day 2 and day 30 without computer tomography. All patients will undergo a final clinical examination after 6 months. The study will recruit 400 patients.", + "relevance_explanation": "The patient is relevant to the clinical trial as he is 85 years old, which meets the age criterion of being 18 years or older. Additionally, he is willing to provide informed consent and comply with the trial protocol, which is another inclusion criterion. However, the patient does not have a newly diagnosed chronic subdural hematoma operated within the last 48 hours, which is a critical inclusion criterion for the trial. This significantly reduces the relevance of the patient to the trial, as the primary focus is on patients who have undergone recent surgery for chronic subdural hematoma.", + "eligibility_explanation": "The patient meets the age criterion and is willing to provide informed consent, which are positive indicators for eligibility. He is not excluded by any of the exclusion criteria provided, such as being in a moribund state, having geographic follow-up difficulties, or having a CSH due to specific conditions. However, the patient does not meet the critical inclusion criterion of having a newly diagnosed chronic subdural hematoma operated within the last 48 hours, which is essential for participation in the trial. This makes the patient ineligible for the trial despite meeting other criteria." + }, + "NCT01869855": { + "matching_score": -1.0, + "agg_score": -0.2, + "trial_score": -1.2, + "qrels_score": 1, + "brief_summary": "The aim of our study is to investigate in randomized controlled fashion whether the recurrence and complication rate, after insertion of subperiosteal drainage in the treatment of chronic subdural haematoma, is higher compared to insertion of subdural drainage.~We hypothesize that patients treated with a subperiosteal drainage do not show higher recurrence rates than those treated with a subdural drainage, and suffer less complications.", + "relevance_explanation": "The patient is an 85-year-old male, which satisfies the age requirement for the trial. However, there is no mention of the patient having a chronic subdural hematoma, which is the primary condition being studied in the trial. Without evidence of this condition, the relevance to the trial is significantly reduced.", + "eligibility_explanation": "The patient does not meet the inclusion criteria as there is no indication of a chronic subdural hematoma verified on cranial CT or MRI. While the patient is willing to provide informed consent, this alone does not make him eligible for the trial. There is no information suggesting exclusion based on the criteria provided, but the lack of inclusion criteria fulfillment results in ineligibility." + } + } + }, + "sigir-201415": { + "patient_summary": "A 36-year-old woman presents with 12 weeks of amenorrhea, increased vaginal spotting, lower abdominal tenderness, and nausea. Physical examination shows an 18-week sized uterus and cervical dilation. A negative pregnancy test and ultrasound findings suggest a differential diagnosis of vesicular mole versus fibroid degeneration.", + "trials": { + "NCT00180739": { + "matching_score": 0.22222, + "agg_score": 0.4, + "trial_score": 0.62222, + "qrels_score": 2, + "brief_summary": "The study objective is to develop data for the safety of pregnancies after thermal ablation of uterine fibroids by MR guided Focused Ultrasound using the Ex Ablate 2000 system.", + "relevance_explanation": "The patient is a 36-year-old woman with a differential diagnosis that includes uterine fibroids, which aligns with the target condition of the clinical trial. The trial is focused on women with uterine fibroids who wish to pursue pregnancy, and the patient is within the age range specified in the inclusion criteria. Additionally, the patient is willing to provide informed consent and comply with the trial protocol, which is relevant to the trial's requirements.", + "eligibility_explanation": "The patient meets the age requirement and has a differential diagnosis that includes fibroids, making her potentially eligible. She is not pregnant, as confirmed by a negative pregnancy test, and her uterine size is within the acceptable range. However, there is insufficient information regarding her fertility history, ovarian function, use of non-steroidal treatments, MRI visibility of fibroids, and other specific trial requirements. Therefore, while she is not excluded by any criteria, the lack of detailed information on several inclusion criteria limits her eligibility." + }, + "NCT00277680": { + "matching_score": -1.0, + "agg_score": -0.7, + "trial_score": -1.7, + "qrels_score": 1, + "brief_summary": "Women with symptomatic uterine fibroids are treated either by Uterine Fibroid Embolization (UFE) or laparoscopic occlusion. The study hypothesis is that laparoscopic occlusion of uterine vessels and UFE have equal effect on bleeding symptoms. Menstrual bleeding reduction six months after treatment is the main endpoint. Secondary endpoints include participants assessment of symptom relief, and volume reduction of fibroids measured by MRI. We will also investigate possible differences in postoperative course, symptom reduction, complication, and recurrence. Patients are controlled with regular intervals up to five years after treatment.", + "relevance_explanation": "The patient presents with symptoms that could be associated with uterine fibroids, such as an enlarged uterus and abdominal tenderness. The differential diagnosis includes fibroid degeneration, which aligns with the target condition of the trial. However, there is no explicit mention of menorrhagia or bulk symptoms, which are key inclusion criteria for the trial. Despite this, the potential presence of fibroids makes the trial relevant to the patient.", + "eligibility_explanation": "The patient is not excluded by most of the exclusion criteria, such as malignancy, current pregnancy, or being postmenopausal. However, the exclusion criterion regarding uterus size exceeding the umbilical level is likely met, as the physical exam notes an 18-week sized uterus, which typically exceeds the umbilical level. This makes the patient ineligible for the trial despite the relevance of her condition." + } + } + }, + "sigir-201416": { + "patient_summary": "The patient is a 28-year-old female experiencing neck and shoulder pain, left hand and arm paresthesias, and slight tremors. She developed spastic arm movements, sweating, agitation, anxiety, malaise, difficulty swallowing, and marked hydrophobia after returning from a trip. She was hospitalized with these symptoms.", + "trials": { + "NCT02374814": { + "matching_score": 1.0, + "agg_score": 0.45, + "trial_score": 1.45, + "qrels_score": 2, + "brief_summary": "The purpose of this study is to compare the effectiveness of a two dose versus a three dose schedule and intramuscular versus intradermal injection for pre-exposure prophylaxis.", + "relevance_explanation": "The patient is relevant to the clinical trial as she is a 28-year-old female, which fits the age and gender criteria for the trial. Additionally, she is able to provide informed consent and comply with the trial protocol, as indicated in the patient note. The trial is focused on rabies pre-exposure prophylaxis, and the patient's symptoms and recent history suggest a potential rabies exposure, making the trial relevant to her current medical situation.", + "eligibility_explanation": "The patient meets the inclusion criteria regarding age, gender, and ability to provide informed consent. However, there is insufficient information regarding exclusion criteria such as pregnancy status, participation in other clinical trials, previous rabies vaccination, or rabies immune globulin administration. Additionally, while the patient exhibits anxiety and agitation, it is unclear if these symptoms constitute a major psychiatric disorder that would exclude her from the trial. Therefore, while she is likely eligible, the lack of information on these exclusion criteria prevents a full eligibility confirmation." + }, + "NCT02238756": { + "matching_score": -0.66667, + "agg_score": -0.9, + "trial_score": -1.56667, + "qrels_score": 1, + "brief_summary": "The purpose of this clinical trial is to investigate the safety and tolerability of IM administered CV8102 and an IM administered combination of CV8102 and rabies vaccine in humans.", + "relevance_explanation": "The patient is relevant to the clinical trial as she is experiencing symptoms consistent with rabies, which is the target condition of the trial. The trial aims to investigate the safety and tolerability of a rabies vaccine, which is pertinent given the patient's symptoms of hydrophobia and other neurological signs suggestive of rabies.", + "eligibility_explanation": "The patient is excluded from the trial due to the presence of acute disease symptoms such as spastic arm movements, sweating, agitation, anxiety, malaise, difficulty swallowing, and hydrophobia, which are likely to interfere with the safety assessment of the investigational products. Although she meets some inclusion criteria, the acute nature of her symptoms makes her ineligible." + } + } + }, + "sigir-201417": { + "patient_summary": "The patient is a 48-year-old white male with a history of common variable immunodeficiency (CVID) presenting with acute abdominal pain, fever, and signs of shock. Physical examination and imaging revealed hepatomegaly and free intraperitoneal fluid, leading to the discovery of a ruptured liver abscess during exploratory laparotomy. The abscess was surgically drained, and the patient was admitted to the ICU post-surgery.", + "trials": { + "NCT01745731": { + "matching_score": 0.26667, + "agg_score": 0.4, + "trial_score": 0.66667, + "qrels_score": 2, + "brief_summary": "This is a randomized controlled trial in which the safety and feasibility of cell therapy medicinal product shall be measured by comparing the variables of the response after treatment compared to baseline prior to implementation. Secondarily the results obtained are compared with each of the study groups.~Patients will receive concomitant basic pharmacological treatment for maintaining liver function.~All patients will be equally medically treated. The hypothetic test is to propose mononuclear cells from the bone marrow infused in the territory hepatic portal remaining segments (II and III) to be performed while contralateral portal embolization provides progenitor cells hepatic regenerative capacity that would shorten the time of liver regeneration and increase residual volume, facilitating the realization of an extended hepatectomy with greater assurance of maintaining proper residual function and adequate surgical margins.", + "relevance_explanation": "The patient is relevant to the clinical trial as he meets several key inclusion criteria. He is 48 years old, which satisfies the age requirement. He has a ruptured liver abscess, which qualifies as a liver space-occupying lesion and a liver injury threatening the viability of the remaining liver tissue, both of which are relevant to the trial's focus on liver conditions requiring extended hepatic resection. Additionally, the patient is willing to provide informed consent and comply with the trial protocol, which is a necessary condition for participation.", + "eligibility_explanation": "The patient meets several inclusion criteria: he is of the appropriate age, has a liver space-occupying lesion, and is willing to provide informed consent. He does not meet any exclusion criteria based on the available information. However, there is insufficient information regarding several other inclusion criteria, such as standard analytical parameters, leukocyte, neutrophil, and platelet counts, as well as AST/ALT and creatinine levels. Despite this, the absence of exclusion criteria and the fulfillment of key inclusion criteria suggest a moderate level of eligibility." + }, + "NCT02556359": { + "matching_score": -0.66667, + "agg_score": 0.3, + "trial_score": -0.36667, + "qrels_score": 0, + "brief_summary": "The molecular mechanisms participating in the various aspects of the DNA Damage Response (DDR) are absolutely essential to maintain the genome dynamics essential to all living organisms. The most commonly studied consequence of faulty DDR is genome instability participating in cancer onset. In the present proposal, we wish to explore another aspect of DDR, not relevant to cancer, which is its absolute requirement at several key steps of the development, maturation, and function of the immune system.~The most spectacular consequences of faulty DNA repair processes with respect to the immuno-hematopoietic tissue are the complete block of B and T lymphocytes maturation owing to defective DNA joining phase during V(D)J recombination resulting in patients with Severe Combined Immune Deficiency (SCID).~The objectives of this study are to increase our knowledge on the role of the various DNA repair processes in the development, the maintenance, and the function of the immune system and thus, to better understand why and how dysfunctions of these DNA repair processes result in human severe conditions such as CVID, LOCID or other manifestations of immune disorders such as autoimmunity.~The explorations of DNA repair mechanisms in the patients will allow us to establish the genetic diagnosis in some patients with until now undefined molecular diagnosis. This is of immediate importance for the patients and their families, as it not only contributes to a better understanding of the patients' condition, but also allows providing genetic counseling for the families.", + "relevance_explanation": "The patient is relevant to the clinical trial because he has a history of Common Variable Immunodeficiency (CVID), which is one of the primary conditions being studied in the trial. However, the trial also targets immune deficiency and early bone marrow failure (BMF) in childhood, which does not apply to this patient as he is 48 years old. Therefore, while the patient is relevant due to his CVID, he does not meet the age-related aspect of the trial's target conditions.", + "eligibility_explanation": "The patient is eligible based on the inclusion criterion for Common Variable Immunodeficiency (CVID), as he has a history of this condition. He is not excluded based on the criterion of refusal to consent, as he is willing to provide informed consent. However, there is no information indicating that the patient is a genetic patient, which is another inclusion criterion, and he does not meet the age-related criterion for early BMF in childhood. Therefore, while he meets some criteria, he does not fully meet all the inclusion criteria, particularly the age-related one." + } + } + }, + "sigir-201418": { + "patient_summary": "The 6-month-old male infant is experiencing oliguria with urine output less than 0.2 mL/kg/hr following major surgery. He presents with generalized edema, elevated blood pressure, and abnormal laboratory findings including elevated blood urea nitrogen and serum creatinine levels. Urinalysis reveals hematuria, granular casts, and a high fractional excretion of sodium, suggesting acute kidney injury.", + "trials": { + "NCT00557219": { + "matching_score": 0.5, + "agg_score": 0.4, + "trial_score": 0.9, + "qrels_score": 2, + "brief_summary": "The purpose of the study is to compare the effect of fenoldopam and ketanserin on kidney function preservation in patients at high risk for renal failure after cardiac surgery. Acute, oliguric renal failure develops in up to 2% of patients undergoing cardiac surgery. Some of them require renal replacement therapy and despite that mortality in this group exceeds 30-60%. The investigators await that the use of fenoldopam and/or ketanserin may decrease the rate of severe renal failure.", + "relevance_explanation": "The patient is relevant to the clinical trial as he is experiencing oliguria and has risk factors for acute renal failure, which are key conditions being studied in the trial. However, it is not confirmed that the surgery was cardiac, which is a specific requirement of the trial.", + "eligibility_explanation": "The patient meets several inclusion criteria: he has oliguria with urine output < 0.2 mL/kg/hr and risk factors for acute renal failure such as generalized edema and elevated serum creatinine. He is not excluded based on the available exclusion criteria, as he does not have chronic renal failure or a serum creatinine level > 2 mg/dL. However, there is insufficient information regarding the type of surgery (cardiac) and the administration of furosemide, which are critical for full eligibility." + }, + "NCT01260883": { + "matching_score": -0.0, + "agg_score": -0.9, + "trial_score": -0.9, + "qrels_score": 1, + "brief_summary": "Infants handle ketorolac differently than adults. Study of handling of this pain medication given to infants following surgery. Detailed analysis of how the drug is eliminated from age 2 months to 18 months. Compared morphine use in infants who received the drug to the group getting placebo. Safety testing for kidney and liver function, breathing measured by continuous oximetry, and any bleeding issues.", + "relevance_explanation": "The patient is a 6-month-old infant who has undergone major surgery, which aligns with the trial's focus on postoperative infants aged 2 to 18 months. This makes the patient highly relevant to the trial.", + "eligibility_explanation": "While the patient meets the inclusion criteria of being a postoperative infant within the specified age range, he is excluded due to potential renal issues indicated by elevated blood urea nitrogen and serum creatinine levels. This exclusion is based on the trial's criterion regarding renal disease." + } + } + }, + "sigir-201419": { + "patient_summary": "The patient is a 52-year-old African American man with a history of heavy smoking and drinking, experiencing progressive dysphagia over several months. Initially, he had difficulty swallowing meat, which progressed to other solids, soft foods, and liquids. He reports a sensation of obstruction at the lower end of his sternum and has lost 25 pounds.", + "trials": { + "NCT00256529": { + "matching_score": 0.33333, + "agg_score": 0.8, + "trial_score": 1.13333, + "qrels_score": 2, + "brief_summary": "This is a prospective descriptive cross sectional study to determine the percentage of patients presenting with dysphagia who are found to have eosinophilic esophagitis (EoE) and to establish which presenting factors warrant esophageal biopsies. We hypothesize that a greater than expected percentage of patients who are biopsies will have histologic changes consistent with EE.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as he is a 52-year-old man presenting with progressive dysphagia, which aligns with the trial's focus on patients with dysphagia to determine the presence of eosinophilic esophagitis. The patient's symptoms and age fit the inclusion criteria for the study.", + "eligibility_explanation": "The patient meets the age and symptom criteria for inclusion. There is no information suggesting he has significant cardiopulmonary disease or contraindications to EGD, nor is there evidence of esophageal varices, which are exclusion criteria. He is willing to provide informed consent and comply with the trial protocol. However, there is insufficient information regarding his ability to undergo EGD and biopsies, which slightly affects the eligibility score." + }, + "NCT02509286": { + "matching_score": 0.18182, + "agg_score": 0.1, + "trial_score": 0.28182, + "qrels_score": 0, + "brief_summary": "The trial is designed to investigate differences in outcome of patients with esophageal adenocarcinoma and junctional adenocarcinoma treated with perioperative (neoadjuvant + adjuvant) chemotherapy (FLOT) plus surgical resection versus neoadjuvant chemoradiation (CROSS) plus surgical resection.", + "relevance_explanation": "The patient presents with progressive dysphagia and significant weight loss, which are symptoms consistent with esophageal adenocarcinoma, a target condition of the trial. However, there is no histological confirmation of adenocarcinoma, which is crucial for relevance. The patient's age is appropriate for the trial, and he is willing to provide informed consent, which aligns with the trial's requirements.", + "eligibility_explanation": "The patient meets the age criterion and is willing to provide informed consent, which are two inclusion criteria. However, there is insufficient information regarding the histological confirmation of adenocarcinoma, cancer staging, and other health parameters such as cardiac, bone marrow, respiratory, renal, and liver functions. Additionally, there is no information on exclusion criteria such as tumor histology, operability, or prior treatments. Therefore, the eligibility is limited by the lack of comprehensive clinical data." + } + } + }, + "sigir-201420": { + "patient_summary": "A 32-year-old woman involved in a car accident has sustained multiple fractures in her upper and lower extremities. She is alert but presents with a tender abdomen, guarding, rebound tenderness, and absent bowel sounds, indicating potential internal injuries. Her vital signs are stable with a blood pressure of 134/74 mm Hg and a pulse of 87/min.", + "trials": { + "NCT01594385": { + "matching_score": 0.66667, + "agg_score": 0.7, + "trial_score": 1.36667, + "qrels_score": 2, + "brief_summary": "The goal of this study is to test the effects of Seprafilm adhesion barrier on patients who are undergoing open abdomen damage control management for traumatic injuries when compared to no adhesion barrier use. Specifically, the researchers wish to study the effects of Seprafilm adhesion barrier on:~the number and intensity of adhesions,~whether there is any difference between treatment groups (Seprafilm vs. no Seprafilm) who go on to successful definitive abdominal closure,~rate of occurrence of secondary complications (such as abscesses) associated with short- and long-term beneficial effects of reducing adhesion formation,and~whether there is any difference between treatment groups regarding patient functional recovery.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as she is a trauma patient with abdominal issues, likely undergoing damage control/open abdomen management, which aligns with the trial's focus on trauma patients with open abdomen conditions. Additionally, she is 32 years old, meeting the age criterion for the trial.", + "eligibility_explanation": "The patient meets the inclusion criteria of being a trauma patient undergoing potential damage control/open abdomen management and is over 18 years old. There is no information suggesting she is a prisoner or pregnant, thus not excluded by those criteria. However, there is insufficient information regarding her life expectancy, which is a necessary inclusion criterion. This lack of information slightly reduces her eligibility score." + }, + "NCT02255487": { + "matching_score": 0.5, + "agg_score": 0.2, + "trial_score": 0.7, + "qrels_score": 2, + "brief_summary": "The purpose of this study was to compare the rate of surgical site infections in patients randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen.", + "relevance_explanation": "The patient is relevant to the clinical trial as she is a 32-year-old woman who has sustained abdominal trauma, which aligns with the trial's focus on patients undergoing open abdominal laparotomy for abdominal trauma or acute surgical abdomen. However, it is not explicitly stated whether she requires an open abdominal laparotomy, which is a key aspect of the trial's inclusion criteria.", + "eligibility_explanation": "The patient meets the basic inclusion criteria of age and consent. However, there is insufficient information to confirm if she requires an open abdominal laparotomy, which is crucial for eligibility. There are no indications that she meets any exclusion criteria, but the lack of information on the necessity of surgery limits her eligibility." + } + } + }, + "sigir-201421": { + "patient_summary": "The patient is a 21-year-old female presenting with progressive joint pain, fatigue, hair loss, and a facial rash. She exhibits a non-palpable purpura on her calves and swelling in her wrists and ankles. Laboratory findings reveal normocytic anemia, thrombocytopenia, positive ANA and anti-dsDNA, and urine abnormalities including proteinuria and RBC casts.", + "trials": { + "NCT01520155": { + "matching_score": 1.0, + "agg_score": 0.95, + "trial_score": 1.95, + "qrels_score": 2, + "brief_summary": "The key of this prospective study is to identify a potentially increased cardiovascular risk in patients with systemic Lupus erythematodes, with and without renal affection. Three groups of patients will be compared.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as she has systemic Lupus erythematosus (SLE), which is the target condition of the study. The patient's symptoms, such as arthralgias, rash, alopecia, and laboratory findings including positive ANA and anti-dsDNA, normocytic anemia, thrombocytopenia, and renal involvement (proteinuria and RBC casts), strongly indicate SLE. This aligns with the trial's focus on assessing cardiovascular risk in SLE patients.", + "eligibility_explanation": "The patient is fully eligible for the trial as she meets the inclusion criterion of having systemic Lupus erythematosus and is not excluded by any criteria. The trial aims to study cardiovascular risk in SLE patients, and the patient's renal involvement is also relevant to the study's objectives. There are no exclusion criteria that apply to her, making her a suitable candidate for the trial." + }, + "NCT00997100": { + "matching_score": -0.46154, + "agg_score": -0.9, + "trial_score": -1.36154, + "qrels_score": 1, + "brief_summary": "This is an exploratory open label single arm study to evaluate changes in disease activity and biomarkers in patients with mild active SLE, during treatment with ABR-215757 given as add-on to standard therapy. To be eligible for the study SLE patients should present with symptoms from skin, mouth and/or joints. After a screening period of one week patients will be treated with ABR-215757 for 12 weeks. The initial dose of ABR-215757 will be 1.5 mg/day. There will be an option to increase the dose to 3.0 mg/day following 28 days of treatment. Follow-up visits will take place 4 weeks and 8 weeks after last day of treatment. Disease activity during treatment will be studied using the Systemic Lupus Erythematosus disease Activity Index (SLEDAI-2K) as well as organ system specific disease activity indexes (CLASI for skin involvement and number of swollen/tender joints using 28- and 66/68-joint counts). At specified time points during the study, blood samples and biopsies will be collected for analysis of established and exploratory biomarkers of SLE. Concomitant SLE treatment allowed include: prednisolone or equivalent at a dose of \u226415 mg/day, hydroxychloroquine, azathioprine, methotrexate and mycophenolate mofetil, all at stable doses from specified timepoints prior to the study and throughout the study.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as she has been diagnosed with Systemic Lupus Erythematosus (SLE), which is the target condition of the trial. She presents with symptoms such as arthritis, rash, and renal involvement, which align with the trial's focus on mild active SLE with symptoms from skin, mouth, and/or joints.", + "eligibility_explanation": "The patient meets several inclusion criteria, such as being over 18 years old, fulfilling at least 4 ACR criteria for SLE, and presenting with active SLE symptoms including arthritis and skin rash. However, she is excluded due to active renal lupus, as indicated by protein and RBC casts in her urine, which is a disqualifying factor according to the exclusion criteria." + } + } + }, + "sigir-201422": { + "patient_summary": "A 15-year-old girl presents with abdominal pain that started periumbilically and localized to the right lower quadrant. She has had no appetite since yesterday and exhibits localized rebound tenderness in the right lower quadrant. An abdominal ultrasound shows a markedly edematous appendix.", + "trials": { + "NCT00723788": { + "matching_score": 1.0, + "agg_score": 1.0, + "trial_score": 2.0, + "qrels_score": 2, + "brief_summary": "Study to find out if MRI can diagnose appendicitis in children as well as or better than CT scan and/or ultrasound scan performed at the same time. No additional contrast material or sedation will be used to perform the MRI.", + "relevance_explanation": "The patient is a 15-year-old girl presenting to the ER with symptoms consistent with appendicitis, including right lower quadrant pain and a markedly edematous appendix on ultrasound. This aligns perfectly with the trial's target condition of appendicitis in children and the inclusion criterion of being aged 8-18 years, referred from the emergency department for suspected appendicitis, and having received an ultrasound. Therefore, the patient is highly relevant to the trial.", + "eligibility_explanation": "The patient meets the inclusion criterion as she is within the age range of 8-18 years, presents with suspected appendicitis, and has undergone an abdominal ultrasound. There are no indications of exclusion criteria such as issues with MRI metal screening, claustrophobia, or the need for sedation. Thus, the patient is fully eligible for the trial." + }, + "NCT00236912": { + "matching_score": -1.0, + "agg_score": -0.3, + "trial_score": -1.3, + "qrels_score": 1, + "brief_summary": "The purpose of this study is to compare the efficacy and safety of two treatment regimens in treating patients with complicated appendicitis. Appendicitis requires antibiotic treatment when the appendix ruptures (complicated appendicitis). This is a study comparing intravenous (IV) antibiotic therapy of levofloxacin/metronidazole versus piperacillin/tazobactam for 4 to 14 days. Patients may be switched to oral therapy after 48 hours, at the doctor's discretion.", + "relevance_explanation": "The patient is relevant to the clinical trial as she presents with symptoms of appendicitis, which is the target condition of the study. However, the trial specifically targets complicated appendicitis, which involves a ruptured appendix, and there is no evidence in the patient note that her appendicitis is complicated. Therefore, while she is relevant to the general condition being studied, she does not fully match the specific condition of interest.", + "eligibility_explanation": "The patient does not meet the inclusion criterion of having complicated appendicitis, as there is no evidence of a ruptured appendix. Additionally, there is insufficient information regarding her ability to take oral medication post-surgery and her use of birth control. On the exclusion side, there is no information suggesting she meets any exclusion criteria, but the lack of evidence for complicated appendicitis significantly impacts her eligibility." + } + } + }, + "sigir-201423": { + "patient_summary": "The patient is a 63-year-old man with a history of heavy smoking, presenting with cough, shortness of breath, and cyanosis. He has a past medical history of spinal stenosis, Type 2 Diabetes, hypothyroidism, and mild psoriasis. His symptoms include productive cough and difficulty breathing, with a chest x-ray showing hyperinflation, suggesting possible chronic obstructive pulmonary disease (COPD).", + "trials": { + "NCT00170222": { + "matching_score": 0.66667, + "agg_score": 0.7, + "trial_score": 1.36667, + "qrels_score": 2, + "brief_summary": "The role of antibiotic therapy in patients with COPD remains controversial. While the outcome of several clinical trials is in favour of antibiotics, the quality of these studies in insufficient. In this study the efficacy of doxycycline is compared to placebo. All concommitant treatment (steroids, bronchodilator therapy, physiotherapy) is standardized.~The investigators hypothesize that patients with an acute exacerbations will have a better outcome when treated with antibiotics.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as he presents with symptoms consistent with an acute exacerbation of COPD, which is the primary focus of the trial. The trial aims to evaluate the efficacy of antibiotics in such cases, and the patient's symptoms, including cough, shortness of breath, and the need for home oxygen, align with the trial's target condition.", + "eligibility_explanation": "The patient meets the key inclusion criteria of having an acute exacerbation of COPD and the ability to take oral medication. There is no information suggesting he is excluded based on the exclusion criteria provided. However, there is insufficient information regarding his ability to perform lung function tests and whether he has received any pretreatment with antibiotics or corticosteroids, which are critical for full eligibility assessment. Therefore, while he is likely eligible, the lack of complete information on some criteria slightly reduces the eligibility score." + }, + "NCT02219360": { + "matching_score": 0.5, + "agg_score": 0.7, + "trial_score": 1.2, + "qrels_score": 2, + "brief_summary": "Chronic obstructive pulmonary disease has become a serious global health care and public health problems due to its high prevalence, high morbidity and heavy economic burden. Acute exacerbation of chronic obstructive pulmonary disease is one of the most important causes of death in patients with COPD. Systemic corticosteroids therapy is recommended in COPD exacerbations. In clinical practice for the treatment of acute exacerbation of COPD\uff0c antibiotic application is still controversial. Evidence from current guideline is based on strict criteria from randomized controlled trials, thus the given condition is simplified. Patients meet the criteria account for the minority in the real world. Therefore, it is still not clear whether most patients benefit from the recommended treatment. In our design, hospitalized patients with acute exacerbation of COPD will be enrolled, with their treatment, arterial hypoxemia, recovery time and length of hospitalization being observed. The main purpose is to evaluate the benefit effect of current recommended treatment of acute exacerbation of COPD in the real world.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as he presents with symptoms consistent with an acute exacerbation of chronic obstructive pulmonary disease (COPD), which is the target condition of the trial. The patient is 63 years old, meeting the age criterion of being over 40. Although the note does not explicitly state that the patient is hospitalized, the severity of symptoms and the use of home oxygen suggest a potential hospitalization, which aligns with the trial's focus on hospitalized patients.", + "eligibility_explanation": "The patient meets the inclusion criterion of being over 40 years old and is likely experiencing an acute exacerbation of COPD, which is the primary condition for inclusion. He is not excluded based on the available exclusion criteria, as there is no evidence of congestive heart failure on the chest x-ray, and no mention of serious cardiac, renal, or hepatic issues. However, there is insufficient information regarding a chest CT to rule out other exclusionary conditions such as lung cancer or interstitial lung diseases. The lack of explicit confirmation of hospitalization slightly reduces the eligibility certainty." + } + } + }, + "sigir-201424": { + "patient_summary": "A 33-year-old male athlete presented with acute abdominal pain following a bike accident a week ago, resulting in blunt trauma to the left hemi-abdomen. He has been experiencing mild abdominal pain since the incident. The patient is in hypovolemic shock with low blood pressure and high heart rate. Imaging revealed a spleen rupture with extended intraperitoneal hemorrhage.", + "trials": { + "NCT02229695": { + "matching_score": 1.0, + "agg_score": 0.7, + "trial_score": 1.7, + "qrels_score": 2, + "brief_summary": "This is a prospective comparison trial. Patients that will be included in the trial are those that will have operations in which their abdominal closure is temporary, i.e. patients sustaining trauma or septic abdomen.~Patients will be grouped according to the method of temporarily abdominal closure (TAC) procedure:~Vacuum-assisted closure (VAC)~Bogota bag (BB), a sterile intravenous bag silo closure. The two methods are currently accepted with no clear cut evidence to prefer one on another. At Soroka Medical Center the decision to choose either of the methods is at the surgeon's discretion.~Intra-abdominal pressure will be measured in all patients by the urinary bladder pressure technique at 6 12 24 ant 48 hours post operation. The measurement is a routine procedure done as part of the monitoring processes of critically ill patients in the General Intensive Care Unit (GICU).~Patients will be evaluated for the development of acute intra abdominal hypertension with or without abdominal compartment syndrome.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as he is a 33-year-old male who is likely undergoing an emergency laparotomy due to a spleen rupture, which aligns with the trial's focus on patients undergoing temporary abdominal closure following trauma. The trial aims to study the effects of different temporary abdominal closure techniques, which is applicable to this patient's situation.", + "eligibility_explanation": "The patient meets the inclusion criterion as he is an adult male undergoing emergency laparotomy with a likely temporary abdominal closure due to trauma. However, there is a potential concern regarding the exclusion criterion related to survival estimates, as the patient's vital signs are critical (BP: 60/30 mmHg, HR: 140/min). Despite this, there is no direct mention of the surgeon's estimate of survival, so the patient cannot be definitively excluded based on this criterion. Therefore, the patient is likely eligible for the trial." + }, + "NCT01771861": { + "matching_score": -0.5, + "agg_score": -0.75, + "trial_score": -1.25, + "qrels_score": 1, + "brief_summary": "The aim of the study is to establish the predictive properties of our trauma team activation protocol, and its individual criteria, and if possible to suggest changes that reduce over- and undertriage.~The study will also give an overview of the frequency and type of emergency procedures at a university hospital trauma center, which can contribute to optimal resource use and indicate which type of surgical skills are necessary in our trauma emergency procedures.", + "relevance_explanation": "The patient is relevant to the clinical trial as he presented to the ER with trauma-related symptoms, specifically a spleen rupture and extended intraperitoneal hemorrhage, which are consistent with the target conditions of trauma and injuries. However, there is no direct evidence that the trauma team was activated, which slightly reduces the relevance.", + "eligibility_explanation": "The patient meets the inclusion criterion of having an Injury Severity Score likely greater than 15 due to the spleen rupture and extended intraperitoneal hemorrhage. However, he is excluded because he was admitted more than 24 hours post-injury, which is a disqualifying factor according to the exclusion criteria." + } + } + }, + "sigir-201425": { + "patient_summary": "An 8-year-old boy experienced a head injury after falling from a bike, initially showing no loss of consciousness. He later developed symptoms of drowsiness, vomiting, bradycardia, hypertension, and impaired movement on the right side. The Glasgow Coma Scale was 6/15, and pupils were asymmetrical, indicating potential intracranial injury.", + "trials": { + "NCT02378311": { + "matching_score": 1.0, + "agg_score": 0.9, + "trial_score": 1.9, + "qrels_score": 2, + "brief_summary": "Cycling injuries are the 3rd most common mechanism of injury in 7-13 year olds[1]. Bicycle injuries have remained one of the commonest causes of paediatric abdominal trauma for over 60 years[2,3]. 15% of child cyclist injuries involve impact with a handlebar; two-thirds of those are abdominal injuries[4]. Handlebar impact is now the commonest mechanism of major paediatric abdominal injury[3]. Serious handlebar injuries often occur after apparently minor falls; they are not unique to riders performing stunts[5].~One small study found that the metal handlebar ends were often exposed on bikes of children sustaining severe abdominal injuries[6]. Most European safety standards do not test grip durability[7-10]. Day-to-day use can damage rubber grips, exposing the underlying metal handlebar tube.~This feasibility study aims to test the research methods that will be used in a subsequent nationwide multicentre study. The main study will investigate the association between injuries and handlebar grip condition.~Children attending study hospitals with any bicycle or kick scooter injury will be invited to participate. Parents of injured children will be invited to complete questionnaires regarding circumstances surrounding the injury and condition of the handlebar ends on the bike or scooter involved. Clinical information regarding the injury will also be collected. The handlebar end condition will be compared between children sustaining a handlebar end injury [Cases] and riders whose injury did not involve the handlebar [Controls].~If exposed handlebar ends are more prevalent amongst riders with handlebar end injuries, injury prevention strategies can focus on methods to prevent damage occurring to grips through day-to-day use. If no such association is found, prevention strategies can be focused elsewhere, such as on design of effective protective clothing.~Data collection for this feasibility study will occur between March 2015 and September 2015.~The Chief Investigator, Mr. Andrew Neilson, funds the feasibility study.", + "relevance_explanation": "The patient is an 8-year-old boy who sustained an injury from a bicycle fall, which aligns with the target conditions of the trial focusing on injuries in children related to cycling. The trial aims to investigate injuries associated with handlebar impacts, and the patient's incident involved a bicycle, making him relevant to the study.", + "eligibility_explanation": "The patient meets all inclusion criteria: he is within the age range (0-15 years), presented to a hospital for treatment, sustained an injury, and the incident involved a non-motorized bicycle. He is not excluded by any exclusion criteria, as there is no indication of involvement in a motor vehicle collision, injury by another rider, or the presence of 'bull bars' on the bicycle. Additionally, the patient can provide informed consent, and he was not dead on arrival or during admission." + }, + "NCT00282269": { + "matching_score": 0.33333, + "agg_score": 0.4, + "trial_score": 0.73333, + "qrels_score": 2, + "brief_summary": "The purpose of this study is:~To determine the safety and feasibility of performing an international multi-centre randomized control trial of early and prolonged hypothermia to improve outcome in children with severe traumatic brain injury (TBI).~To determine whether in children with severe traumatic brain injury, prolonged initial hypothermia (minimum 72 hours at 32-33 degrees) improves the proportion of good outcomes 12 months after injury when compared to initial normothermia (36-37 degrees).", + "relevance_explanation": "The patient is highly relevant to the clinical trial as he has a severe traumatic brain injury, indicated by a GCS of 6/15, which aligns with the trial's target condition. Additionally, the patient is within the specified age range of 1 to 16 years. However, there is no information on whether the patient is mechanically ventilated, which is a requirement for inclusion.", + "eligibility_explanation": "The patient meets the age criterion and has a severe traumatic brain injury with a GCS of 6/15, which suggests potential eligibility. However, the lack of information on mechanical ventilation status and CT scan results limits the ability to fully assess eligibility. The patient does not meet any exclusion criteria based on the available information." + } + } + }, + "sigir-201427": { + "patient_summary": "The patient is a 21-year-old with a family history of multiple colonic polyps, as both siblings underwent total proctocolectomy due to hundreds of colonic adenomas. The patient has dozens of small colonic polyps in the rectosigmoid area, which are benign adenomas. The family history and current findings suggest a hereditary predisposition to colonic polyps.", + "trials": { + "NCT01713881": { + "matching_score": 1.0, + "agg_score": 0.8, + "trial_score": 1.8, + "qrels_score": 2, + "brief_summary": "This will be a retrospective chart review of 880-1000 patients who had a colonoscopy and were found to have a tubular adenoma between the years of 2004-2008. We will compare the rate and timing of completion of repeat colonoscopies pre and post establishment of a polyp registry (tracking system) in 2006. Each group will be composed of up to 500 subjects consecutively identified from all the patients who underwent colonoscopy and were found to have a tubular adenoma (Group 1-2004 to 2006, Group 2 2007-2008).", + "relevance_explanation": "The patient is relevant to the clinical trial as he has been found to have colonic adenomas, which aligns with the trial's focus on colon adenoma surveillance. The trial is a retrospective chart review of patients with tubular adenomas found during colonoscopy, and while the patient had adenomas found during sigmoidoscopy, this is closely related and relevant. Additionally, the patient is over 18 years old, meeting the age criterion for relevance.", + "eligibility_explanation": "The patient meets the inclusion criteria as he is over 18 years old and has adenomas found on sigmoidoscopy, which is similar to colonoscopy. There are no exclusion criteria that apply to him, as there is no mention of a diagnosis of IBD, and he is not under 18. Therefore, the patient is fully eligible for the trial." + }, + "NCT01187901": { + "matching_score": -0.75, + "agg_score": 0.45, + "trial_score": -0.3, + "qrels_score": 0, + "brief_summary": "The purpose of this study is to determine in a randomized, placebo-controlled, phase II trial if the combination of sulindac and erlotinib causes a significant regression of duodenal and colorectal adenomas in familial adenomatous polyposis (FAP) and attenuated FAP (AFAP) patients.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as he is 21 years old and has a family history of multiple colonic polyps, which suggests a clinical diagnosis of familial adenomatous polyposis (FAP). This aligns with the trial's target condition of adenomatous polyposis coli. Additionally, the patient is willing to provide informed consent, which is a requirement for participation.", + "eligibility_explanation": "The patient meets the key inclusion criterion of being 18 years or older with a clinical diagnosis of FAP. He is also willing to provide informed consent. However, there is insufficient information regarding other inclusion criteria such as the presence of duodenal polyps, recent surgeries, WHO performance status, bone marrow function, liver function, and NSAID use. Similarly, there is no information on exclusion criteria such as prior investigational drug use, recent malignancies, severe medical conditions, cardiac issues, lung function, infections, liver disease, and laboratory values. Therefore, while the patient is likely eligible based on the available information, the lack of data on several criteria prevents a full eligibility determination." + } + } + }, + "sigir-201429": { + "patient_summary": "The patient is a 51-year-old woman seeking advice on osteoporosis prevention. She has a history of significant hypertension and diet-controlled Type 2 Diabetes. She is a current smoker and has recently entered menopause. Her primary concern is the risk of hip fractures as she ages.", + "trials": { + "NCT01978834": { + "matching_score": 1.0, + "agg_score": 0.95, + "trial_score": 1.95, + "qrels_score": 2, + "brief_summary": "This study is designed for clinical validation of the novel ultrasound device (Bindex\u00ae, Bone Index Finland Ltd.). In a preliminary study technique has been validated in Finnish elderly woman population with 285 healthy and 56 osteoporotic subjects (n = 341 in total). Significant and good correlation was observed between Density Index (DI) determined with Bindex and femoral bone mineral density determined with DXA (r = 0.65 - 0.70). In addition, with determination of 90% sensitivity and specificity thresholds, significant number (65-75%) of patients could be diagnosed without additional verification with DXA.~First, the thresholds for DI will be determined by measuring 70 osteoporotic and 70 healthy patients (n = 140) with Bindex and DXA within four decades of age; age 50 to 59 years, age 60 to 69 years, age 70 to 79 years, and age 80 to 89 years. The feasibility of DI for diagnostics of osteoporosis and evaluation of bone mineral density (BMD) will be assessed. The thresholds for the BMD estimate obtained with DI will be determined for osteoporotic and non-osteoporotic patients. For fracture risk assessment, DI measurements are used to predict the outcome of currently available fracture risk assessment tools.~To investigate optimal configuration of ultrasound parameters and patient characteristics for prediction of proximal femur and lumbar spine BMD for women in each four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.~To develop national diagnostic thresholds for DI in prediction of osteoporosis status with a reference female population (American-Caucasian) in each four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as she is a 51-year-old female, which fits the target demographic of the study focusing on women aged 50 to 89 years. Additionally, she is concerned about osteoporosis, which is the condition being studied in the trial.", + "eligibility_explanation": "The patient meets all the inclusion criteria: she is female and within the age range of 50 to 89 years. She does not meet any of the exclusion criteria: there is no indication that she has opted out of research contact, she can provide informed consent, there is no mention of infeasibility of hip BMD measurement, and there are no open wounds that would preclude ultrasound measurements. Therefore, she is fully eligible for the trial." + }, + "NCT00703417": { + "matching_score": -0.8, + "agg_score": -0.3, + "trial_score": -1.1, + "qrels_score": 1, + "brief_summary": "For this cross-sectional case control pilot study 30 women, 55-75 years old with type II diabetes will be recruited. Diabetes will be defined as self-report of diabetes previously diagnosed by a physician, use of hypoglycemic medications, or fasting glucose > 126 mg/dl (7.0mM) in accordance with the American Diabetes Association criteria. The diabetic patient population will be divided into 2 groups: patients with status post low energy fractures of the proximal humerus, the proximal femur, the ankle and the foot (n=10) versus diabetic patients with no fractures or low energy trauma fracture history (n=10). An additional group of 10 diabetic postmenopausal women will be recruited and will have magnetic resonance imaging (MRI) of the lower back only. Caucasian, Asian and Hispanic women will be combined since a previous study suggested that BMD is very similar in these 3 population and that ethnic differences are minimal. In addition a population of 10 age-matched, BMI-matched, race-matched healthy women, without osteoporotic fractures will be examined. In all of these volunteers a medical history will be obtained to ensure good health status and rule out chronic diseases that would have an impact on bone metabolism. Patients will undergo MRI, QCT and high-resolution peripheral quantitative computed tomography (HR-pQCT) examinations to determine bone mineral density and bone structure/quality.~The hypothesis of this pilot project is that type II diabetic patients with and without low-energy fractures have a different trabecular bone architecture and composition, which is also different when compared to normal age-matched healthy patients. Architectural differences in these three patient groups may be visualized with high resolution MRI and high-resolution peripheral quantitative computed tomography (HR-pQCT) and will be most pronounced at the calcaneus and the distal tibia. Analyzing structure parameters obtained from high resolution MRI and spectroscopy may improve our understanding of the pathophysiology of diabetic bone disease and the prediction of fracture risk in an elderly diabetic population.", + "relevance_explanation": "The patient is a postmenopausal woman with a history of diabetes, which aligns with the trial's focus on postmenopausal women with type II diabetes. However, she is only 51 years old, which is below the required age range of 55-75 years. Additionally, her diabetes is diet-controlled, and there is no evidence of it being treated with insulin or oral therapies, which is a requirement for the trial. These factors significantly reduce her relevance to the trial.", + "eligibility_explanation": "The patient does not meet the age criterion as she is 51 years old, below the required 55-75 years. Her diabetes is diet-controlled, not treated with insulin or oral therapies, which is necessary for inclusion. There is no information on her BMI, and she has no history of fractures, which are important for the trial. She does not meet any exclusion criteria, but the lack of inclusion criteria fulfillment makes her ineligible." + } + } + }, + "sigir-201430": { + "patient_summary": "The patient is a 72-year-old man experiencing increasing calf pain when walking uphill, suggestive of peripheral artery disease. He has a history of myocardial infarction and transient ischemic attack. His blood pressure has worsened recently despite medication, and he presents with a right carotid bruit and diminished pulses in the lower extremities.", + "trials": { + "NCT00721006": { + "matching_score": 0.4, + "agg_score": 0.3, + "trial_score": 0.7, + "qrels_score": 2, + "brief_summary": "The purpose of this research study is to compare in patients with double-sided claudication if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in one of the severly diseased ischemic limbs(legs)versus the control limb that receives a placebo product.~Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decrease blood flow to the extremities (mainly feet and legs) and has progressed to the point of severe pain and even skin ulcers or sores.~LI needs comprehensive treatment since the condition will not improve on its own. The overall goal of treatment is to reduce pain and increase blood flow to improve symptoms or save the leg and feet. In many cases, current options for treatment including medications, surgery or endovascular procedures have not been successful.~In the last few years, investigators have explored therapies aimed to increase blood flow to the ischemic vessel by transplanting cells that will promote the development of new vessels in the diseased leg.~The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriated blood supply to the leg.~Patients eligible to participate in the this study are those suffering from double-sided claudication with poor circulation or severe leg blockages, which are not candidates for surgical procedures.~Once the mixture of stem cells is prepared and the patient's bone marrow is ready, cells will be transplanted into the calf muscle of one the the diseased legs while the other diseased leg will receive the placebo. Clinical study to evaluate and compare the efficacy of the stem cell transplant will be performed for six months post cell transplant.", + "relevance_explanation": "The patient is relevant to the clinical trial as he is a 72-year-old male with symptoms of claudication, which aligns with the trial's focus on severe leg ischemia and peripheral artery disease. The trial targets patients with double-sided claudication and poor circulation, which is consistent with the patient's symptoms of calf pain when walking uphill and diminished pulses in the lower extremities. However, there is no specific mention of an ABI measurement or resting ischemic pain, which are part of the inclusion criteria.", + "eligibility_explanation": "The patient meets the age criterion and has claudication, which are part of the inclusion criteria. He is not excluded based on the ability to provide informed consent or recent myocardial infarction. However, there is insufficient information regarding ABI measurements, resting ischemic pain, or candidacy for surgical procedures, which are crucial for full eligibility. Additionally, there is no information on previous angiogenic therapy, sensitivity to certain medications, or WBC count, which could affect eligibility. Therefore, while the patient is not explicitly excluded, the lack of information on key inclusion criteria limits the eligibility score." + }, + "NCT02273232": { + "matching_score": 0.0, + "agg_score": 0.0, + "trial_score": 0.0, + "qrels_score": 0, + "brief_summary": "Remote ischemic Preconditioning (RIPC) is a phenomena first observed in cardio-thoracic patients in which exposing the limbs for periods of short intermittent ischemia produces protective effect on heart muscle. The concept was applied to many other parts of the body and the results are positive so far.~No human trials on this concept has been conducted in patients with peripheral vascular disease so far but applying the concept for healthy individuals shows vessels dilatation and animal trials shows degree of new vessels formation in addition to reports of symptoms improvement.~The trial candidates will be allocated blindly in 4 groups. All groups will have advice about exercise which is the standard practice now. The first group will have supervised exercise. The second group will in addition to the supervised exercise get the ischemic preconditioning with the blood pressure cuff. The third group will get the ischemic preconditioning and the fourth group will get the standard exercise advice. All candidates will have Magnetic Resonance Image Scan (MRA) for their blood vessels in the beginning of the trial and again at the end.~The effect of the RIPC (Remote ischemic Preconditioning) and exercises on patient symptoms, new vessel formation and other parameters will be recorded", + "relevance_explanation": "The patient exhibits symptoms consistent with peripheral arterial disease (PVD), such as calf pain when walking and diminished pulses in the lower extremities. These symptoms align with the target condition of the trial, which is focused on patients with peripheral arterial diseases. However, there is no explicit diagnosis of moderate PVD or staging information (Rutherford or Fontaine) provided in the patient note, which limits the relevance. The trial aims to study the effects of remote ischemic preconditioning on PVD, and the patient's symptoms suggest potential relevance to the trial's objectives.", + "eligibility_explanation": "The patient shows symptoms indicative of PVD, which is relevant for the trial. However, there is insufficient information to confirm eligibility based on the inclusion criteria, as there is no explicit diagnosis of moderate PVD or staging information. The patient does not meet any exclusion criteria, such as severe cardiac or respiratory conditions, upper limb PVD, or contraindications for MRA. Therefore, while the patient is not explicitly excluded, the lack of detailed inclusion criteria fulfillment results in a neutral eligibility status." + } + } + }, + "sigir-20151": { + "patient_summary": "The patient is a 44-year-old male presenting with multiple episodes of vomiting with a 'coffee ground' appearance, indicating possible upper gastrointestinal bleeding. He is in a state of hypovolemic shock, evidenced by tachycardia, hypotension, decreased mental status, and cool extremities. He received fluid resuscitation and blood transfusion and was admitted to the ICU for further management.", + "trials": { + "NCT01142245": { + "matching_score": 0.5, + "agg_score": 0.2, + "trial_score": 0.7, + "qrels_score": 2, + "brief_summary": "The investigators previously showed that the use of a high-dose intravenous PPI regimen after endoscopic control of bleeding from peptic ulcers reduced rate of recurrent bleeding, decreased the need for endoscopic and surgical interventions and in general improved patients' outcomes. A trend towards reduced mortality associated with the use of high-dose intravenous PPI was also observed. Recent clinical trials from Asia have provided evidence that high-dose oral PPIs are associated with a reduction in rebleeding. Current meta-analysis suggests that both high dose (intravenous) and low dose (oral) PPIs effectively reduce rebleeding vs placebo. However, there has been no clinical study to compare IV infusion to oral PPI in this patient population.~The purpose of this clinical study is to compare the efficacy and safety of intravenous and oral Esomeprazole in patients with peptic ulcer hemorrhage who are at risk for recurrent bleeding. The investigators hypothesize that using IV infusion is superior to oral PPI.", + "relevance_explanation": "The patient is relevant to the clinical trial as he presents with symptoms consistent with upper gastrointestinal bleeding, which could be due to a peptic ulcer. The trial is focused on preventing recurrent bleeding from peptic ulcers, which aligns with the patient's condition. However, there is no confirmation of ulcer bleeding with Forrest classification, which is a key inclusion criterion.", + "eligibility_explanation": "The patient meets the age criterion and is willing to provide informed consent, which satisfies two inclusion criteria. However, there is no confirmation of ulcer bleeding with Forrest classification, and no information about endoscopic hemostasis being achieved, which are critical for inclusion. The patient does not meet any exclusion criteria based on the available information, but the lack of confirmation of ulcer bleeding and endoscopic hemostasis limits eligibility." + }, + "NCT00843063": { + "matching_score": 0.25, + "agg_score": 0.0, + "trial_score": 0.25, + "qrels_score": 0, + "brief_summary": "Low-dose aspirin can prevent cerebral and cardiovascular accidents in individuals with symptomatic atherothrombotic disease, but its use is frequently limited by gastrointestinal side effects.~The position of H2-receptor antagonists as a step-down therapy after healing of peptic ulcer or erosions by proton pump inhibitor is unclear.~The objective of this randomized, double blinded control study was to compare the efficacy of high-dose famotidine with pantoprazole in the prevention of recurrent dyspeptic or complicated ulcer/ erosions in patients taking low-dose aspirin", + "relevance_explanation": "The patient presents with upper gastrointestinal bleeding, which is relevant to the trial's focus on peptic ulcers/erosions. However, there is no information about the use of low-dose aspirin, which is a key aspect of the trial. The patient's age is appropriate for the trial, but the lack of information on aspirin use and endoscopic findings limits the relevance.", + "eligibility_explanation": "The patient meets the age criterion but lacks information on several key inclusion criteria, such as the use of low-dose aspirin and endoscopic findings of ulcers or erosions. There is also insufficient information to assess most exclusion criteria. Therefore, the eligibility is limited due to missing critical information." + } + } + }, + "sigir-20152": { + "patient_summary": "The patient is a 62-year-old male with a non-productive cough and fever, who is on immunosuppressive medications including prednisone. He was admitted to the hospital and underwent bronchoscopy with bronchoalveolar lavage. The BAL fluid examination revealed owl's eye inclusion bodies, indicating a possible viral infection.", + "trials": { + "NCT02532452": { + "matching_score": 0.6, + "agg_score": 0.6, + "trial_score": 1.2, + "qrels_score": 2, + "brief_summary": "The purpose of this study is to demonstrate that viral specific T-cells (a type of white blood cell) can be generated from an unrelated donor and given safely to patients with viral infections.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as he is immunocompromised and has evidence of a viral infection, which aligns with the trial's target conditions. The trial aims to treat viral infections in immunocompromised hosts, and the patient fits this profile. Additionally, the patient is willing to provide informed consent, which is a requirement for participation.", + "eligibility_explanation": "The patient meets several inclusion criteria: he is immunocompromised with a viral infection, is over 1 day old, and is willing to provide informed consent. However, there is insufficient information regarding the tapering of steroids, the ability to receive treatment in Cincinnati, and whether he has had a stem cell transplant. The patient does not meet any exclusion criteria, as there is no mention of GVHD, bacterial or fungal infections, malignancy relapse, or recent infusion of ATG or alemtuzumab. Overall, the patient is likely eligible but requires further information on certain criteria." + }, + "NCT00034437": { + "matching_score": -0.0, + "agg_score": -0.9, + "trial_score": -0.9, + "qrels_score": 1, + "brief_summary": "This study will evaluate immune responses against cytomegalovirus (CMV). About 80 percent of adults have been exposed to this virus. CMV typically remains dormant (inactive) in the body, causing no problems. In people with immune suppression, however, the virus can become reactivated and cause life-threatening pneumonia. The knowledge gained from this study may be useful in developing ways to improve immune responses to CMV in stem cell transplant recipients.~Healthy normal volunteers between 18 and 65 years of age who have been exposed to cytomegalovirus are eligible for this study. Candidates will be screened with a medical history and blood tests. Those enrolled will provide a 30-milliliter (6-tablespoon) blood sample once a week for 4 weeks and a final sample 2 months later. The blood will be used to design a test to detect immune responses against CMV and determine the differences in these responses among healthy individuals.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as he is within the specified age range (18-65 years) and has evidence of a cytomegalovirus (CMV) infection, indicated by the presence of owl's eye inclusion bodies. Additionally, the patient is willing to provide informed consent, which is a requirement for participation in the trial.", + "eligibility_explanation": "While the patient meets the inclusion criteria of age, CMV seropositivity, and willingness to provide informed consent, he is excluded due to being on immunosuppressive medications, which indicates an immunodeficiency state. This is a disqualifying factor according to the trial's exclusion criteria." + } + } + }, + "sigir-20153": { + "patient_summary": "A 65-year-old male with no significant cardiovascular history presents with acute shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. He recently had a right total hip replacement and experienced delayed rehabilitation due to poor pain management. Physical exam reveals a high respiratory rate and right calf pain.", + "trials": { + "NCT01139632": { + "matching_score": 0.57143, + "agg_score": 0.3, + "trial_score": 0.87143, + "qrels_score": 2, + "brief_summary": "The most common cause of death in patients with NAFLD(Nonalcoholic Fatty Liver Disease) is CAD(Coronary Artery Disease). NAFLD patients have 65% more mortality than general population. The aim of the investigators study is to diagnose early coronary artery disease in NAFLD patient by measuring of PLA2. The investigators expect that PLA2 will higher in patients with patients with combination of CAD, unstable plaque and NAFLD.", + "relevance_explanation": "The patient is relevant to the clinical trial as he presents with chest pain, which may indicate an intermediate risk for coronary artery disease (CAD), a key focus of the trial. Additionally, he is 65 years old, which meets the age criterion, and he is able to provide informed consent. However, there is no mention of nonalcoholic fatty liver disease (NAFLD), which is a primary target condition of the trial, slightly reducing the relevance.", + "eligibility_explanation": "The patient meets several inclusion criteria: he is over 18 years old, can provide informed consent, and presents with chest pain, which may indicate an intermediate risk for CAD. However, there is insufficient information regarding stress tests, which are necessary to fully assess eligibility for some criteria. Additionally, there is no information on the presence of NAFLD, which is a key condition for the trial. The patient is not excluded based on the available exclusion criteria, but the lack of information on NAFLD and stress tests limits full eligibility." + }, + "NCT01326507": { + "matching_score": 0.0, + "agg_score": 0.0, + "trial_score": 0.0, + "qrels_score": 0, + "brief_summary": "The patients presenting with acute pulmonary embolism and right ventricular dysfunction are at high risk for life-threatening events and must be identified in the emergency department for adequate care and hospital admission. Echocardiography can identify right ventricular dysfunction, but this test is not always available, and echocardiographic criteria of right ventricular dysfunction vary among published studies. The primary purpose of this protocol is to study the prognostic value of a cardiac biomarker, h-FABP (heart-type Fatty Acid-Binding Protein) , to identify in the emergency department the patients presenting with high risk pulmonary embolism. As secondary outcomes, H-FABP results will be compared to other cardiac biomarkers (BNP, troponin) and clinical score performances that have been previously studied to stratify the prognosis of patients with pulmonary embolism in the emergency department.", + "relevance_explanation": "The patient presents with symptoms suggestive of a pulmonary embolism, such as acute onset of shortness of breath, tachypnea, and chest pain, which are relevant to the trial's focus on acute pulmonary embolism. However, there is no confirmed diagnosis of pulmonary embolism in the emergency department, which is a key inclusion criterion for the trial. Therefore, while the symptoms align with the trial's target condition, the lack of a confirmed diagnosis reduces the relevance.", + "eligibility_explanation": "The patient shows symptoms that suggest a pulmonary embolism, but there is no confirmed diagnosis, which is necessary for inclusion. The patient is not excluded by any of the exclusion criteria, such as being under guardianship, lacking social insurance, being pregnant, refusing consent, or having a recent myocardial infarction. However, without a confirmed diagnosis of pulmonary embolism, the patient cannot be considered eligible for the trial." + } + } + }, + "sigir-20154": { + "patient_summary": "An 82-year-old woman presented with chest pain and shortness of breath, with EKG showing ST-segment elevations and elevated cardiac enzymes, suggesting a myocardial event. Despite these findings, coronary angiography showed no significant stenosis, but left ventriculography and echocardiogram revealed severe segmental left ventricular dysfunction. The patient has a history of hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis, and dementia.", + "trials": { + "NCT00844987": { + "matching_score": 1.0, + "agg_score": 0.95, + "trial_score": 1.95, + "qrels_score": 2, + "brief_summary": "The main aim of the study is a comparison of serum and plasma concentration of VEGF (Vascular Endothelial Growth Factor), HGF (Hepatocyte Growth Factor) and PDGF (Platelet Derived Growth Factor) with markers of myocardial injury as troponin I, hsCRP, CK-MB and NT-proBNP assessed in patients with first episode of acute coronary syndrome (ACS) in their lives and the estimation of assumed value of VEGF, HGF and PDGF in prognosis of cardiovascular complications at 3 months follow up especially with respect to myocardial infarction (MI), exacerbation of angina, reintervention (PTCA,CABG), symptoms of heart failure, stroke, rehospitalization due to cardiovascular reasons and death. The dynamics of changes in serum and plasma concentration of growth factors in comparison with values of myocardial injury markers will be checked. For the realization of the purpose of the study biochemical measurements will be performed twice i.e. just after admission to hospital and 24h later. Area of a myocardial injury will be estimated by echocardiography examination.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as she presents with an acute coronary syndrome (ACS), evidenced by typical chest pain, ST-segment elevation on ECG, and elevated cardiac biomarkers (CK-MB and Troponin T). These are key inclusion criteria for the trial, which aims to study growth factors in patients with ACS. Additionally, the patient underwent coronary angiography, which aligns with the trial's protocol for assessing myocardial injury.", + "eligibility_explanation": "The patient meets all the inclusion criteria: she experienced typical chest pain, has ST-segment elevation on ECG, underwent coronary angiography, and will provide informed consent. She does not have a known past history of myocardial infarction, which is an exclusion criterion, and she will sign informed consent, fulfilling all necessary conditions for participation. Therefore, she is fully eligible for the trial." + }, + "NCT01243255": { + "matching_score": 0.0, + "agg_score": 0.0, + "trial_score": 0.0, + "qrels_score": 0, + "brief_summary": "The purpose of the survey is to evaluate the efficacy of treatment of hypercholesterolemia in Polish patients who are currently on lipid- lowering pharmacological therapy . Efficient treatment is defined as achievement of the LDL cholesterol level goals according to the European Society of Cardiology 2007 guidlines.", + "relevance_explanation": "The patient is relevant to the clinical trial because she has hypercholesterolemia, which is the target condition of the trial. However, there is no information provided about whether she is currently on lipid-lowering drug treatment, which is a key inclusion criterion for the trial. This lack of information reduces the relevance score.", + "eligibility_explanation": "The eligibility of the patient is uncertain due to the lack of information regarding her current treatment for hypercholesterolemia. There is no evidence that she is on lipid-lowering therapy, which is required for inclusion. Additionally, there is no information about the duration of any such treatment or changes in medication, which are also important criteria. The patient is not excluded based on the available exclusion criteria, as she will provide informed consent. However, the absence of information about a recent blood sample for lipid profile and glucose further complicates the eligibility assessment." + } + } + }, + "sigir-20155": { + "patient_summary": "A 31-year-old woman presents with a 2-week history of joint pain and fatigue, initially experiencing right ankle swelling and difficulty walking, which resolved. She now has pain, swelling, and stiffness in her knees, hips, and right elbow, along with intermittent fevers and chest pain.", + "trials": { + "NCT02407106": { + "matching_score": -1.0, + "agg_score": -0.1, + "trial_score": -1.1, + "qrels_score": 1, + "brief_summary": "The purpose of this study is to determine whether daily treatment with Streptococcus Salivarius BLIS K-12 prevents streptococcal throat infection in children that have had an episode of rheumatic fever.", + "relevance_explanation": "The clinical trial is focused on children with a history of rheumatic fever, specifically targeting the prevention of streptococcal throat infections in this population. The patient is a 31-year-old woman with no previous medical problems and no history of rheumatic fever or rheumatic heart disease. Therefore, the trial is not relevant to her condition as it is designed for a pediatric population with a specific medical history that she does not have.", + "eligibility_explanation": "The patient does not meet the inclusion criteria as she does not have rheumatic heart disease or a history of rheumatic fever, which are necessary for participation in the trial. Additionally, the trial is aimed at children, and the patient is an adult. While she is willing to comply with the trial protocol, this does not affect her eligibility given the lack of relevant medical history and age mismatch." + }, + "NCT02118818": { + "matching_score": -1.0, + "agg_score": -0.3, + "trial_score": -1.3, + "qrels_score": 1, + "brief_summary": "Rheumatic fever (RF) is an autoimmune disease that is mediated by the cellular and humoral immune response that follows an untreated pharyngeal Streptococcus pyogenes infection. The most serious complication is rheumatic heart disease (RHD), one of the most common problems facing children and young adults worldwide, which leads to chronic valvular lesions. It is estimated that 60% of all acute rheumatic fever cases will develop RHD.~The pathogenesis of RHD is complex with both environmental and genetic factors contributing to its etiology. The investigators know little about the genetic etiology, cellular events and modifiers of progression of RHD, and there exists a wide range of disease severity and progression to severe valve pathology.~Thus, the investigators will study the genetics of RHD in Rwanda, a country with a very high incidence of RHD, using a combination of next-generation targeted exome capture, transcriptomics, and expressed quantitative trait loci (eQTL) analysis.", + "relevance_explanation": "The patient presents with symptoms such as joint pain, fever, and chest pain, which could be indicative of rheumatic fever, a precursor to rheumatic heart disease (RHD). However, there is no direct mention of rheumatic heart disease or any echocardiographic evidence of RHD in the patient note. The trial is focused on the genetics of RHD, and without confirmed RHD, the relevance is limited.", + "eligibility_explanation": "The patient does not meet the inclusion criterion of having clinical and echocardiographic signs of RHD, as there is no mention of such signs in the patient note. Additionally, the patient is not excluded based on the absence of congenital heart disease. However, the lack of confirmed RHD makes the patient ineligible for the trial." + } + } + }, + "sigir-20156": { + "patient_summary": "The patient is a 46-year-old woman experiencing significant weight loss, sweating, insomnia, and diarrhea over the past 9 months. She reports increased appetite and episodes of heart palpitations. Physical examination reveals warm, sweaty hands, an irregular pulse at 110 bpm, hyperreflexia, and mild exophthalmia.", + "trials": { + "NCT01717352": { + "matching_score": 0.66667, + "agg_score": 0.2, + "trial_score": 0.86667, + "qrels_score": 2, + "brief_summary": "The present study will test the effectiveness of two different approaches for preparing overweight/obese individuals for weight loss: 1)providing important information about weight control, including dispelling common myths; or 2) developing a consistent sleep and eating routine to prepare for the challenges of a weight control intervention.", + "relevance_explanation": "The patient is relevant to the clinical trial as she is within the age range of 21 to 65 years, which is one of the inclusion criteria. Additionally, her symptoms of insomnia suggest she may sleep 7 hours or less most nights, aligning with another inclusion criterion. However, there is no information about her BMI, which is crucial for determining relevance to a weight loss study targeting overweight or obese individuals.", + "eligibility_explanation": "The patient meets the age criterion and likely meets the sleep criterion due to her insomnia. However, there is insufficient information about her BMI, which is necessary to confirm her eligibility for a study focused on overweight or obese individuals. Additionally, there is no information on exclusion criteria such as the use of medications affecting sleep, sleep apnea, or shift work, which could impact her eligibility." + }, + "NCT02375451": { + "matching_score": -1.0, + "agg_score": -0.3, + "trial_score": -1.3, + "qrels_score": 1, + "brief_summary": "Radioiodine (I-131) therapy for thyroid disease is known to decrease salivary function in adult patients. The impact of pediatric I-131 exposure on salivary function is unknown. The investigators goals are to answer this question by measuring salivary gland function before and after I-131 administration in children who receive radioiodine therapy at our hospital for thyroid disease.", + "relevance_explanation": "The patient presents with symptoms consistent with hyperthyroidism, which is one of the target conditions of the clinical trial. However, the trial is specifically focused on the effects of radioiodine therapy on salivary function in children, and the patient is an adult. Additionally, there is no mention of the patient having received radioiodine therapy, which is a key aspect of the trial. Therefore, while the patient's condition is relevant, the specific focus of the trial on pediatric patients and radioiodine therapy limits the relevance.", + "eligibility_explanation": "The patient does not meet the inclusion criteria as there is no evidence of having received radioiodine therapy, nor is there information to suggest she is part of a negative control group. She is not excluded based on language, as she can provide informed consent. However, the trial's focus on pediatric patients further limits her eligibility." + } + } + }, + "sigir-20157": { + "patient_summary": "The patient is a 20-year-old female college student experiencing fatigue, increased sleep and appetite, difficulty concentrating, anhedonia, and feelings of guilt. Her physical exam and laboratory tests, including hemoglobin, hematocrit, and thyroid stimulating hormone, are normal.", + "trials": { + "NCT01632319": { + "matching_score": 0.5, + "agg_score": 0.2, + "trial_score": 0.7, + "qrels_score": 2, + "brief_summary": "The purpose of this study is to investigate the effectiveness of 2 different therapy courses for undergraduate college students who binge drink and experience depressive symptoms.", + "relevance_explanation": "The patient is a 20-year-old undergraduate college student, which aligns with the trial's target demographic of undergraduate students aged 18-24. She exhibits symptoms of depression, which is one of the target conditions of the trial. However, there is no information provided about her binge drinking behavior, which is a key component of the trial's focus. This lack of information on binge drinking reduces the relevance slightly, but her depressive symptoms and student status still make her a relevant candidate for the trial.", + "eligibility_explanation": "The patient meets the inclusion criteria for age and student status. She shows symptoms of depression, but there is no BDI-II score provided to confirm the severity of her depression, which is necessary for full inclusion. Additionally, there is no information on her binge drinking behavior, which is a critical inclusion criterion. She does not meet any exclusion criteria, as there is no evidence of substance dependence, bulimia, psychosis, bipolar disorder, recent psychosocial treatment, or recent changes in antidepressant medication. Due to the lack of information on binge drinking and BDI-II score, her eligibility is limited." + }, + "NCT02633449": { + "matching_score": 0.0, + "agg_score": 0.5, + "trial_score": 0.5, + "qrels_score": 0, + "brief_summary": "The study will investigate whether cognitive behavioral psychotherapy (CBT) combined with prefrontal transcranial direct current stimulation (tDCS) is more efficacious with regard to symptom reduction in depressed patients than CBT combined with sham-tDCS or CBT alone.", + "relevance_explanation": "The patient presents with symptoms consistent with depression, such as fatigue, increased sleep and appetite, difficulty concentrating, anhedonia, and feelings of guilt. These symptoms align with the target condition of major depression for the clinical trial. However, there is no explicit diagnosis of unipolar major depressive disorder, which is a key inclusion criterion. Despite this, the symptoms suggest a high likelihood of relevance to the trial's focus on depression treatment.", + "eligibility_explanation": "The patient does not have any exclusionary conditions such as neurological diseases, manic episodes, psychotic symptoms, recent psychotherapy, or electroconvulsive therapy. However, the lack of a confirmed diagnosis of unipolar major depressive disorder limits full eligibility. Additionally, there is no information on current medication, which could potentially affect eligibility if the patient is on medications other than SSRIs or Mirtazapine. Therefore, while the patient is not excluded by any criteria, the absence of a confirmed diagnosis and medication information results in partial eligibility." + } + } + }, + "sigir-20158": { + "patient_summary": "The patient is a 10-year-old boy experiencing nighttime snoring, pauses in breathing, and restlessness with awakenings. He shows signs of excessive daytime sleepiness, lack of attention, and declining academic performance. There is no history of headaches or night terrors.", + "trials": { + "NCT00393913": { + "matching_score": 0.5, + "agg_score": 0.85, + "trial_score": 1.35, + "qrels_score": 2, + "brief_summary": "Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person repeatedly stops breathing, or experiences shallow breathing for short periods of time during sleep. Daytime sleepiness is a common symptom of OSA and may affect an individual's level of alertness throughout the day. The primary purpose of this study is to evaluate the relationship between the severity of sleep-disordered breathing and levels of daytime alertness at baseline (untreated state) in a group of subjects with and without sleep apnea. In addition the change in daytime sleepiness in subjects with sleep apnea being treated with a continuous positive airway pressure (CPAP) machine, a common treatment for OSA will also be assessed.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as he exhibits symptoms consistent with obstructive sleep apnea (OSA), such as nighttime snoring, pauses in breathing, and daytime sleepiness, which are key focus areas of the trial. The trial aims to evaluate the relationship between sleep-disordered breathing and daytime alertness, which aligns with the patient's symptoms.", + "eligibility_explanation": "The patient meets the primary inclusion criterion by exhibiting symptoms of OSA, including snoring and daytime sleepiness. There is no information suggesting the presence of other sleep disorders, unstable medical conditions, or use of psychotropic medications, which are exclusion criteria. The patient is a 10-year-old boy, so pregnancy is not applicable, and he can provide informed consent, indicating no communication impairments. However, there is insufficient information regarding the patient's stable medical history and medication changes, which slightly affects the eligibility score." + }, + "NCT02562040": { + "matching_score": 0.0, + "agg_score": 0.0, + "trial_score": 0.0, + "qrels_score": 0, + "brief_summary": "The purpose of this study is to evaluate the effects of early adenotonsillectomy (eAT) on the behavior, sleep-disordered breathing symptoms and quality of life for children who snore, but do not have obstructive sleep apnea, as well as identify factors that moderate responses to the surgery. Half of participants will receive eAT, while the other half will be observed with watchful waiting and supportive care.", + "relevance_explanation": "The patient is relevant to the clinical trial as he exhibits symptoms of sleep-disordered breathing, such as nighttime snoring, pauses in breathing, and restlessness, which align with the trial's focus on evaluating adenotonsillectomy for children with sleep-disordered breathing. However, there is no direct evidence of a diagnosis of mild sleep-disordered breathing, and the frequency and duration of snoring are not specified, which limits the relevance.", + "eligibility_explanation": "The patient shows potential eligibility as he is not excluded by any of the exclusion criteria provided. However, there is insufficient information to confirm eligibility for the inclusion criteria, such as the lack of a polysomnogram, tonsillar hypertrophy assessment, and ENT evaluation. Therefore, while the patient is not disqualified, there is not enough information to confirm full eligibility." + } + } + }, + "sigir-20159": { + "patient_summary": "The patient is a 10-year-old child presenting with myalgia, cough, and shortness of breath, following a recent viral illness with low-grade fever, abdominal pain, and diarrhea. The child has a history of exposure to a farm with domestic pigs. Current symptoms include cyanosis, neck stiffness, and periorbital edema. Lab results show leukocytosis with significant eosinophilia.", + "trials": { + "NCT01766830": { + "matching_score": -0.0, + "agg_score": -0.8, + "trial_score": -0.8, + "qrels_score": 1, + "brief_summary": "Tropical fevers have been a diagnostic challenge from the antiquity. Nowadays, despite the availability of good diagnostic capacities, undifferentiated febrile illnesses continue to be a thorny problem for travel physicians. In developing countries, the scarcity of skilled personnel and adequate laboratory facilities makes the differential diagnosis of fevers even more complex. Health care workers must often rely on syndrome-oriented empirical approaches to treatment and might overestimate or underestimate the likelihood of certain diseases. For instance Neglected Tropical Diseases (NTD) contribute substantially to the burden of persistent (more than 1 week) fevers in the Tropics, causing considerable mortality and major disability. These diseases are however rarely diagnosed at primary health care (PHC) level. The difficulty in establishing the cause of febrile illnesses has resulted in omission or delays in treatment, irrational prescriptions with polytherapy, increasing cost and development of drug resistance.~In resource-limited settings, clinical algorithms constitute a valuable aid to health workers, as they facilitate the therapeutic decision in the absence of good laboratory capacities. There is a critical lack of appropriate diagnostic tools to guide treatment of NTDs. While clinical algorithms have been developed for some NTDs, in most cases they remain empirical. Besides, they rarely take into account local prevalence data, do not adequately represent the spectrum of patients and differential diagnosis at the primary care level and often have not been properly validated. The purpose of the study is to develop evidence-based Rapid Diagnostic Test (RDT)-supported diagnostic guidelines for patients with persistent fever (\u2265 1 week) in the Democratic Republic of the Congo (DRC), Sudan, Cambodia and Nepal.", + "relevance_explanation": "The patient is relevant to the clinical trial as they present with a persistent fever lasting more than one week, which aligns with the trial's focus on patients with persistent fevers in tropical regions. Additionally, the patient is within the age range specified by the trial's inclusion criteria.", + "eligibility_explanation": "While the patient meets the inclusion criteria of having a fever for more than one week and being of eligible age, they are excluded due to the need for immediate intensive care as indicated by signs of respiratory distress. This exclusion criterion significantly impacts their eligibility for the trial." + } + } + }, + "sigir-201510": { + "patient_summary": "The patient is a 38-year-old woman experiencing severe premenstrual and menstrual pelvic pain, heavy and irregular periods, and occasional spotting between periods. She has a history of infertility treatment over two years and an ectopic pregnancy at age 26.", + "trials": { + "NCT02340533": { + "matching_score": 1.0, + "agg_score": 0.95, + "trial_score": 1.95, + "qrels_score": 2, + "brief_summary": "The purpose of this study is to develop and evaluate a hysteroscopic endo-myometrial biopsy for diagnosing adenomyosis.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as she presents with symptoms that align with the target condition of adenomyosis, such as severe premenstrual and menstrual pelvic pain, heavy and irregular periods, and occasional spotting. These symptoms match the inclusion criteria of dysmenorrhea, chronic pelvic pain, menorrhagia, and metrorrhagia. Additionally, the patient is willing to provide informed consent and comply with the trial protocol, which is necessary for participation.", + "eligibility_explanation": "The patient meets the inclusion criteria as she exhibits symptoms of dysmenorrhea, chronic pelvic pain, menorrhagia, and metrorrhagia, which are indicative of pelvic congestion and relevant to the study of adenomyosis. There are no exclusion criteria that apply to her, as she is willing to provide informed consent and comply with the trial protocol. Therefore, she is fully eligible for the trial." + }, + "NCT01377519": { + "matching_score": -0.25, + "agg_score": -0.45, + "trial_score": -0.7, + "qrels_score": 1, + "brief_summary": "This is a pilot randomized, blinded, placebo-controlled trial of a noninvasive, FDA approved treatment for uterine fibroids called MR Guided Focused Ultrasound (MRgFUS). Our hypothesis is that MRgFUS provides superior relief of fibroid symptoms compared with the placebo, a sham MRgFUS treatment. The investigators will recruit 20 premenopausal women with symptomatic uterine fibroids to participate in the trial. Participants will be randomly assigned in a 2:1 ratio to the active treatment arm (MRgFUS) versus the sham MRgFUS treatment. Participants will remain blinded to their group assignment for 3 months. After 3 months, participants will be told their treatment group and those assigned to the sham group will be offered complimentary MRgFUS if they desire it. Women will be excluded if they are inappropriate candidates for a 3 month delay in fibroid treatment, such as those with significant anemia. The investigators will assess the change from baseline to 1 and 3 months after treatment in fibroid symptoms, quality of life, fibroid volume measured by MRI, and hematocrit.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as she is a premenopausal woman experiencing symptoms that could be associated with uterine fibroids, such as severe pelvic pain and heavy, irregular periods. These symptoms align with the target condition of the trial, which is uterine fibroids.", + "eligibility_explanation": "The patient meets several inclusion criteria: she is over 18, premenopausal, and has symptoms suggestive of fibroids. However, there is insufficient information regarding the accessibility of fibroids for treatment and her hematocrit level. Importantly, she is excluded due to unexplained menstrual irregularity, which is a specific exclusion criterion. This significantly impacts her eligibility." + } + } + }, + "sigir-201511": { + "patient_summary": "The patient is a 56-year-old Caucasian female experiencing increased sensitivity to cold, fatigue, decreased appetite, constipation, hyporeflexia, dry skin, and slow movement and speech. These symptoms suggest a possible underlying endocrine disorder.", + "trials": { + "NCT01197183": { + "matching_score": 0.5, + "agg_score": 0.3, + "trial_score": 0.8, + "qrels_score": 2, + "brief_summary": "This observational survey with prospective and/or retrospective follow-up is designed to study practices for the initial treatment of hypothyroidism in France without modifying subject treatment.", + "relevance_explanation": "The patient exhibits symptoms consistent with hypothyroidism, such as cold sensitivity, fatigue, constipation, hyporeflexia, and dry skin, which aligns with the target condition of the trial. However, there is no direct evidence of a recent diagnosis of hypothyroidism, which is a key inclusion criterion. The patient is willing to provide informed consent and comply with the trial protocol, which is relevant for participation. Overall, the patient is relevant to the trial due to the symptomatic presentation, but the lack of a confirmed recent diagnosis reduces the relevance.", + "eligibility_explanation": "The patient meets the inclusion criterion of providing informed consent and does not meet any exclusion criteria, such as recent participation in another clinical trial or inability to follow up. However, the lack of information regarding a recent diagnosis of hypothyroidism and contraindications to L\u00e9vothyrox limits the eligibility. Therefore, while the patient is not excluded, the eligibility is not fully confirmed due to missing diagnostic information." + }, + "NCT01862510": { + "matching_score": 0.0, + "agg_score": 0.2, + "trial_score": 0.2, + "qrels_score": 0, + "brief_summary": "The study evaluates whether hypothyroid patients requiring elevated doses of levothyroxine to maintain a euthyroid state are at increased risk of having celiac disease. It also attempts to determine if there is a threshold level of levothyroxine needed to maintain a euthyroid state in patients with hypothyroidism that should prompt serologic testing for celiac disease.", + "relevance_explanation": "The patient exhibits symptoms consistent with hypothyroidism, such as cold sensitivity, fatigue, hyporeflexia, and dry skin, which are relevant to the trial's focus on hypothyroid patients. However, there is no explicit mention of a formal diagnosis of hypothyroidism or the use of thyroid replacement therapy, which are key inclusion criteria for the trial. This limits the relevance but does not eliminate it entirely, as the symptoms strongly suggest the possibility of hypothyroidism.", + "eligibility_explanation": "The patient shows symptoms indicative of hypothyroidism, which aligns with the trial's inclusion criteria. However, there is no confirmation of a hypothyroidism diagnosis or the use of thyroid replacement therapy, which are necessary for inclusion. On the exclusion side, there is no evidence of any disqualifying treatments or procedures, such as thyroid surgery or specific medications. Therefore, while the patient is not explicitly excluded, the lack of confirmed inclusion criteria limits eligibility." + } + } + }, + "sigir-201512": { + "patient_summary": "The patient is a 44-year-old man who sustained a skull fracture in an automobile accident. He presented with clear fluid dripping from his nose, severe headache, fever, and nuchal rigidity. These symptoms suggest a possible cerebrospinal fluid leak and meningitis.", + "trials": { + "NCT02418169": { + "matching_score": 0.0, + "agg_score": 0.6, + "trial_score": 0.6, + "qrels_score": 2, + "brief_summary": "This study evaluates the association between traumatic brain injuries and craniofacial or/and skull fractures. Purpose is to find out the amount of missed diagnoses and improve primary diagnostics of trauma patients.", + "relevance_explanation": "The patient is relevant to the clinical trial as he has sustained a skull fracture, which is one of the target conditions of the study. The trial aims to evaluate the association between traumatic brain injuries and skull fractures, and the patient fits this profile. However, there is no information about a craniofacial fracture or the Glasgow Coma Scale (GCS) score, which limits the relevance slightly.", + "eligibility_explanation": "The patient meets the inclusion criterion of having a skull fracture, which is relevant to the study's focus on craniofacial and skull fractures. There is no exclusion criterion that applies to the patient, as he was admitted to the hospital and did not die before admission. However, the lack of information on the GCS score means we cannot fully confirm eligibility based on the severe traumatic brain injury criterion." + }, + "NCT02467309": { + "matching_score": 0.0, + "agg_score": 0.0, + "trial_score": 0.0, + "qrels_score": 0, + "brief_summary": "The purpose of this study is to determine whether deficiency of Vitamin D has association with outcomes of children with bacterial meningitis.", + "relevance_explanation": "The patient presents with symptoms consistent with bacterial meningitis, such as fever and nuchal rigidity, which are relevant to the trial's focus on bacterial meningitis. However, the trial is specifically targeting children, and the patient is an adult, which significantly reduces the relevance.", + "eligibility_explanation": "The patient shows clinical signs of probable bacterial meningitis but lacks cerebrospinal fluid examination results to confirm the diagnosis. Additionally, the trial is for children, and the patient is an adult, making him ineligible." + } + } + }, + "sigir-201513": { + "patient_summary": "A 5-year-old boy presents with progressively worsening dysphagia, drooling, fever, and vocal changes. He appears toxic and leans forward while sitting, with a muffled 'hot potato' voice. The parents report delaying some of his vaccines and deny foreign body ingestion or trauma.", + "trials": { + "NCT01255670": { + "matching_score": 0.2, + "agg_score": -0.2, + "trial_score": -0.0, + "qrels_score": 0, + "brief_summary": "Treatment of peritonsillar abscess varies. To study whether broad spectrum antibiotics are required in addition to abscess drainage, a prospective, double blind, placebo-controlled, randomized study on 200 adult patients with peritonsillar abscess is performed. 100 patients are given penicillin and metronidazole and 100 patients get penicillin and placebo. Recovery and recurrence are analyzed.", + "relevance_explanation": "The clinical trial is focused on the treatment of peritonsillar abscess in adults, while the patient is a 5-year-old boy with symptoms that could suggest a peritonsillar abscess but without a confirmed diagnosis. Additionally, the trial is specifically for adult patients, which makes the patient less relevant to this trial.", + "eligibility_explanation": "The patient does not meet the age requirement as the trial is for adults. There is no confirmed diagnosis of peritonsillar abscess, which is a key inclusion criterion. While the patient is voluntary, other criteria such as language skills, email access, and confirmed diagnosis are not met. The patient is not excluded by any criteria, but the lack of inclusion criteria fulfillment makes him ineligible." + }, + "NCT00315042": { + "matching_score": -0.625, + "agg_score": -0.6, + "trial_score": -1.225, + "qrels_score": 1, + "brief_summary": "This is a multinational, randomized (1:1), double blind, double dummy, comparator-controlled, 2 parallel treatment group study in subjects from 6 months to < 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P).Each subject will receive either telithromycin 25 mg/kg once daily for 5 days or penicillin V, 13.3 mg/kg three times daily for 10 days. Matching placebo for telithromycin and penicillin V will also be dispensed for 5 and 10 days respectively, to provide blinding to the different treatment regimens. A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.", + "relevance_explanation": "The patient is a 5-year-old boy presenting with symptoms such as dysphagia, drooling, fever, and vocal changes, which are consistent with pharyngitis. The trial targets children aged 6 months to less than 13 years with Streptococcus pyogenes tonsillitis/pharyngitis. However, there is no specific mention of Streptococcus pyogenes infection in the patient note, which is a key requirement for the trial. Despite this, the age and some symptoms align with the trial's focus, making the patient somewhat relevant.", + "eligibility_explanation": "The patient meets the age criterion and presents with symptoms like fever and pain on swallowing, which are part of the inclusion criteria. However, there is no confirmation of a Streptococcus pyogenes infection through a rapid detection test, which is crucial for eligibility. Additionally, the patient's symptoms suggest possible epiglottitis, an exclusion criterion, which disqualifies him from the trial. Therefore, despite meeting some inclusion criteria, the exclusion criterion related to deep tissue infection makes the patient ineligible." + } + } + }, + "sigir-201514": { + "patient_summary": "A 27-year-old pregnant woman at 11 weeks gestation presents with anemia, thrombocytopenia, and macrocytosis. Despite iron supplementation, her hemoglobin levels remain low, and she has difficulty swallowing. Laboratory findings suggest hemolytic anemia with elevated LDH, anisocytosis, poikilocytosis, and hemosiderinuria.", + "trials": { + "NCT01308112": { + "matching_score": 1.0, + "agg_score": 0.7, + "trial_score": 1.7, + "qrels_score": 2, + "brief_summary": "The purpose of this study is to compare the presence of Plasmodium infection in parturient women who antenatally received a combination of iron-fortified foods with iron supplements versus iron-fortified foods only.", + "relevance_explanation": "The patient is a 27-year-old pregnant woman at 11 weeks gestation, which fits the inclusion criteria for age and gestational period. The trial focuses on prenatal iron supplementation, and the patient is already receiving iron supplements due to mild iron deficiency. This makes her relevant to the study, which aims to compare iron supplementation methods in pregnant women.", + "eligibility_explanation": "The patient meets the inclusion criteria of being a woman aged 15-45 and being pregnant with a gestational age of less than 23 weeks. She is not excluded by the criteria of failing to provide a blood sample, having an initial hemoglobin concentration below 90 g/L, or carrying multiples. She will provide informed consent, which is required. There is no evidence of sickle cell anemia, epilepsy, diabetes, eclampsia, pre-eclampsia, mental retardation, or a metabolic disorder. However, there is insufficient information regarding her plans to deliver outside the research clinic or leave the homestead, which could potentially affect her eligibility. Despite these uncertainties, the available information suggests she is likely eligible." + }, + "NCT00827463": { + "matching_score": -0.0, + "agg_score": -0.9, + "trial_score": -0.9, + "qrels_score": 1, + "brief_summary": "Estimate the efficiency of a strategy of premature screening of the maternal anaemia during the first quarter of pregnancy versus the usual strategy of screening of the anaemia during the sixth month.", + "relevance_explanation": "The patient is a pregnant woman at 11 weeks gestation, which aligns with the trial's focus on early detection of anemia during the first trimester of pregnancy. Her condition of anemia is directly relevant to the trial's target condition.", + "eligibility_explanation": "The patient meets the inclusion criterion as she is at the beginning of her pregnancy. However, she is excluded due to receiving iron supplementation, which could be considered a periconceptional treatment against anemia. There is no information on whether she speaks French, but this does not affect the current eligibility assessment." + } + } + }, + "sigir-201515": { + "patient_summary": "Karen is a 72-year-old woman with a history of hypertension and type 2 diabetes who recently experienced a cryptogenic stroke. She was treated with thrombolytic therapy and her symptoms resolved. Current evaluations show normal blood pressure, glucose levels, and sinus rhythm, but she reports occasional palpitations, shortness of breath, and chest pain.", + "trials": { + "NCT00932425": { + "matching_score": 0.66667, + "agg_score": 0.4, + "trial_score": 1.06667, + "qrels_score": 2, + "brief_summary": "Atrial fibrillation (AF) is a common and treatable cause of ischemic stroke, but it can be paroxysmal and asymptomatic, and therefore difficult to detect. Patients with stroke routinely undergo 24 hours of continuous cardiac telemetry during hospitalization for stroke as a means of excluding AF. Small studies indicate that extending the duration of monitoring with portable outpatient telemetry devices detects more cases of AF. However, these studies are small and lack control groups, and cannot demonstrate that prolonged cardiac monitoring detects more cases of AF than routine clinical follow-up. The investigators therefore propose a pilot study to determine the feasibility of randomizing patients to prolonged cardiac monitoring or routine clinical follow-up. The investigators will enroll 40 consecutive adult patients seen at the University of California at San Francisco (UCSF) Neurovascular service with cryptogenic stroke or high-risk TIA (ABCD2 score 4 or greater). Enrolled patients will be randomized in a 1:1 fashion. Group A will be assigned to wear an ambulatory cardiac event monitor for 21 days. Group B will be discharged home without a monitor and will serve as controls during routine clinical follow-up. The investigators' primary outcome will be feasibility, defined as more than 80% of randomized patients completing full clinical follow-up and more than 70% of cardiac monitoring if applicable. The investigators' secondary outcomes will be diagnoses of AF at 90 days and 1 year and diagnoses of recurrent stroke at 1 year.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as she has experienced a cryptogenic stroke, which is the target condition of the trial. Additionally, she is over 18 years old and had the stroke within the last 60 days, both of which are inclusion criteria for the trial. However, there is no information indicating that she was seen at UCSF Medical Center, which is a specific requirement for the trial.", + "eligibility_explanation": "The patient meets the age and recent stroke onset inclusion criteria and does not meet any of the exclusion criteria based on the available information. However, there is a lack of information regarding whether she was seen at UCSF Medical Center, which is a critical inclusion criterion. This missing information affects her eligibility status." + }, + "NCT01550588": { + "matching_score": -0.25, + "agg_score": 0.0, + "trial_score": -0.25, + "qrels_score": 0, + "brief_summary": "Background and hypothesis:~The appropriate treatment strategy for secondary stroke prevention in patients with cryptogenic stroke and patent foramen ovale (PFO) remains challenging. Clinical and anatomical variables reported to be risk factors associated with stroke recurrence include older age, large PFO, large right-to-left shunting, and combined atrial septal aneurysm (ASA), which, however, were not confirmed by other studies. The investigators hypothesized that percutaneous closure of PFO could be an effective option for secondary prevention in cryptogenic stroke patients with high-risk PFO.~Trial Objective:~The primary objective of this study is to assess whether percutaneous device closure of PFO is superior to conventional antithrombotic treatment in preventing stroke recurrence in the cryptogenic stroke patients with high-risk PFO.", + "relevance_explanation": "The patient is relevant to the clinical trial as she has experienced a cryptogenic stroke within the last three months, which is a key inclusion criterion. However, the trial specifically targets patients with a high-risk Patent Foramen Ovale (PFO), which has not been diagnosed in this patient. This lack of a PFO diagnosis reduces the relevance of the trial to the patient, as the primary objective of the trial is to assess treatment strategies for cryptogenic stroke patients with high-risk PFO.", + "eligibility_explanation": "The patient meets several inclusion criteria: she had a cryptogenic stroke within the last three months, is willing to participate in follow-up visits, and there are no other potential causes of stroke identified. She also does not meet any exclusion criteria. However, the patient does not meet the critical inclusion criterion of having a high-risk PFO, which is essential for trial eligibility. This significantly impacts her eligibility for the trial." + } + } + }, + "sigir-201516": { + "patient_summary": "A 4-year-old boy presents with wheezing after playing in a sandbox. He has a history of allergic rhinitis but no prior wheezing episodes. The wheezing started suddenly after a brief coughing episode. He is otherwise well-appearing with normal oxygen saturation levels.", + "trials": { + "NCT00839124": { + "matching_score": -1.0, + "agg_score": -0.2, + "trial_score": -1.2, + "qrels_score": 1, + "brief_summary": "This will be a single center, open label study comparing baseline characteristics of recovered sputum cells (collected on screening day) to those of cells recovered 6 hours after inhalational challenge with 20,000 EU Clinical Center Reference Endotoxin (CCRE, a component of air pollution)) within each group as well as cross group comparisons between individuals with allergic asthma (AA's)and normal volunteers (NV's). The primary objective of this study is to test the hypothesis that persons with allergic asthma will have an increased neutrophil response to challenge with 20,000 EU CCRE compared to normal volunteers. Secondary objectives include post CCRE comparison between AA's and NV's with regard to changes in airway cells and blood as well as changes in mucociliary clearance (MCC) in response to inhalation of 20,000 EU CCRE.", + "relevance_explanation": "The clinical trial is focused on individuals with allergic asthma or normal volunteers. The patient is a 4-year-old boy with a history of allergic rhinitis and a recent episode of wheezing, which could suggest a potential for asthma. However, the trial specifically requires a history of episodic wheezing or asthma diagnosis after the age of 6, which the patient does not meet. Additionally, the trial involves an inhalational challenge, which may not be suitable for a child of this age. Therefore, the relevance is low as the patient does not fit the primary target group of the study.", + "eligibility_explanation": "The patient does not meet the inclusion criteria for a history of wheezing or asthma diagnosis after age 6. There is no information on lung function tests, methacholine challenge, or allergy skin tests, which are critical for eligibility. The patient does not meet any exclusion criteria, but the lack of meeting key inclusion criteria makes him ineligible for the trial." + }, + "NCT00930826": { + "matching_score": -1.0, + "agg_score": -0.2, + "trial_score": -1.2, + "qrels_score": 1, + "brief_summary": "Childhood Asthma and Schooling: The Truth Unveiled.", + "relevance_explanation": "The clinical trial is focused on bronchial asthma, a condition the patient does not have a clinical diagnosis for. The patient presented with wheezing for the first time and has no history of asthma, which makes the trial less relevant to him. The trial requires participants to have a clinical diagnosis of bronchial asthma, which the patient does not meet.", + "eligibility_explanation": "The patient does not meet the primary inclusion criterion of having a clinical diagnosis of bronchial asthma. There is also insufficient information regarding the patient's ability to swallow tablets, which is another inclusion criterion. However, the patient is not excluded based on the exclusion criterion related to steroid use, as there is no mention of steroid inhalation or ingestion in the patient note." + } + } + }, + "sigir-201517": { + "patient_summary": "A 32-year-old female with no previous medical history is in good health but has tested HPV positive on her recent pap smear, despite having cytology negative results. She has no current complaints.", + "trials": { + "NCT01231945": { + "matching_score": 0.8, + "agg_score": 0.7, + "trial_score": 1.5, + "qrels_score": 2, + "brief_summary": "Background:~- Low-cost molecular human papillomavirus (HPV) testing may offer a more robust alternative to Pap smears and visual inspection for cervical cancer screening of underserved women. Two low-cost molecular tests for human HPV, the HPV E6 Test and the careHPV test, have been developed to detect cervical cancer by testing for HPV DNA. These tests take between 2 and 3 hours to run and may provide point-of-care (diagnostic testing at or near the site of patient care) testing for HPV. Researchers are interested in evaluating both tests to determine the best strategy for HPV testing of women who live in rural or underserved areas that have a high prevalence of cervical cancer diagnoses.~Objectives:~To evaluate the clinical performance of the HPV E6 Test and careHPV in detecting cervical cancer and precancerous lesions.~To evaluate the best low-cost test or combination of tests for women who have been referred for cervical cancer screening or treatment.~To compare the clinical performance of self-collected specimens versus clinician-collected specimens in detecting cervical cancer and precancerous lesions.~Eligibility:~- Women between 25 and 65 years of age who live in rural China.~Design:~This study involves an initial testing visit and a 1-year followup visit for a high-risk subgroup.~Participants will have the HPV E6 test, careHPV, and a visual inspection test for cervical cancer. For comparison, participants will also have the standard HPV test approved by the U.S. Food and Drug Administration.~Participants who test positive for HPV on any of the above tests will also have colposcopy to collect samples of cervical tissue for further study.~A random sample of women who test negative for HPV will also have colposcopy. Participants may also have biopsies if there is visual evidence of cervical abnormalities.~At the 1-year followup visit, participants in the high-risk subgroup will have the same tests as in the previous visit..", + "relevance_explanation": "The patient is relevant to the clinical trial as she is a 32-year-old female, which fits the age and gender criteria for the study. She has tested positive for HPV, which is a key focus of the trial. The trial aims to evaluate HPV testing methods, and the patient has a recent HPV positive result, making her a suitable candidate for the study.", + "eligibility_explanation": "The patient meets several inclusion criteria: she has not been previously diagnosed with cervical cancer, is female and likely has a cervix, and is physically able to undergo routine cervical cancer screening. She can provide informed consent. There is no information about her pregnancy status, which is a potential exclusion criterion, but not enough to disqualify her without further information. The lack of information on her pregnancy status slightly reduces her eligibility score." + }, + "NCT01446198": { + "matching_score": 0.0, + "agg_score": 0.0, + "trial_score": 0.0, + "qrels_score": 0, + "brief_summary": "The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.", + "relevance_explanation": "The patient is relevant to the clinical trial because she has tested positive for HPV, which is the target condition of the trial. However, the patient note does not provide specific information about the APTIMA HPV Assay or the PANTHER System, which are central to the trial's objectives.", + "eligibility_explanation": "The eligibility of the patient cannot be fully determined due to lack of specific information. The patient note does not confirm if the sample had an APTIMA HPV Assay TIGRIS System result, if an aliquot is available and suitable for testing, or if the sample was randomly selected. Additionally, there is no information on the integrity of the sample. Therefore, while the patient is relevant, her eligibility remains uncertain." + } + } + }, + "sigir-201518": { + "patient_summary": "The patient is a 65-year-old African-American male experiencing worsening shortness of breath on exertion over the past three weeks. He has orthopnea, requiring two to three extra pillows at night. Physical examination reveals bibasilar lung crackles, pitting ankle edema, and jugular venous distension.", + "trials": { + "NCT00534066": { + "matching_score": 0.33333, + "agg_score": 0.2, + "trial_score": 0.53333, + "qrels_score": 2, + "brief_summary": "The purpose of the study is to determine if a series of BNP blood tests performed on patients who present to the Emergency Department with congestive heart failure (CHF) can predict which patients may have adverse outcomes. If the BNP is shown to be predictive of bad outcomes in certain patients, those patients might receive more intensive therapy early to prevent such outcomes. This was a prospective trial enrolling patients who presented to the ED and were diagnosed with heart failure. Subjects had a blood test for BNP, which is elevated in the presence of heart failure, collected twelve hours after their initial clinical BNP was obtained in the ED. Demographics, history, length of hospital stay, and other approved data were collected. At 30 days and 6 months after discharge, a follow up call was made to determine if the subject had required additional emergency care, had been admitted to a hospital, or had died during that period of time.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as he presents with symptoms consistent with congestive heart failure (CHF), which is the target condition of the trial. The trial aims to study patients with CHF in the Emergency Department, and the patient's symptoms such as shortness of breath, difficulty breathing when lying flat, lung crackles, and edema are indicative of CHF. However, there is no explicit mention of a primary diagnosis of CHF in the Emergency Department, which slightly reduces the relevance.", + "eligibility_explanation": "The patient meets the age criterion and is able to provide informed consent, which are positive indicators for eligibility. However, there is insufficient information to confirm a primary diagnosis of CHF in the Emergency Department, which is a crucial inclusion criterion. Additionally, there is no information on hospital admission or transfer to the Observation Unit, which is another inclusion criterion. The patient does not meet any exclusion criteria based on the available information, but the lack of confirmation on key inclusion criteria limits the eligibility." + }, + "NCT00344513": { + "matching_score": 0.0, + "agg_score": 0.0, + "trial_score": 0.0, + "qrels_score": 0, + "brief_summary": "This program is designed to improve medical care and education of hospitalized patients with heart failure and accelerate the initiation of evidence-based heart failure guideline recommended therapies by administering them before hospital discharge. A registry component focusing on admission to discharge and 60- to 90-day follow-up is designed to evaluate the demographic, pathophysiologic, clinical, treatment, and outcome characteristics of patients hospitalized with heart failure.", + "relevance_explanation": "The patient exhibits significant symptoms of heart failure, such as shortness of breath on exertion, orthopnea, bibasilar lung crackles, pitting edema, and jugular venous distension, which are relevant to the trial's focus on heart failure. However, there is no information about the patient being hospitalized, which is a key component of the trial's inclusion criteria.", + "eligibility_explanation": "While the patient shows symptoms consistent with heart failure, there is no information confirming hospitalization for heart failure, which is necessary for inclusion. Additionally, there is no data on systolic or diastolic dysfunction, which is required to meet the inclusion criteria. The absence of exclusion criteria does not impact eligibility negatively." + } + } + }, + "sigir-201519": { + "patient_summary": "The patient is a 66-year-old female with a significant smoking history and chronic cough, experiencing progressive shortness of breath and moderate respiratory distress. Physical examination shows distended neck veins, a barrel-shaped chest, and wheezing. She has a long history of heavy smoking, which suggests possible chronic obstructive pulmonary disease (COPD).", + "trials": { + "NCT00806091": { + "matching_score": -0.5, + "agg_score": 0.95, + "trial_score": 0.45, + "qrels_score": 0, + "brief_summary": "The purpose of this study is to obtain young white blood cells (monocytes) from the investigators donated blood for research into how these cells change into large, mature white blood cells (macrophages) and how smoking causes Chronic Obstructive Pulmonary Disease (COPD).", + "relevance_explanation": "The patient is highly relevant to the clinical trial as she has a significant smoking history and presents with symptoms consistent with COPD, which is the target condition of the trial. The trial aims to study the effects of smoking on COPD, making her a suitable candidate for the research focus.", + "eligibility_explanation": "The patient meets the inclusion criterion of being a smoker with COPD, as evidenced by her significant smoking history and symptoms indicative of COPD. She does not meet the criterion for non-smokers, but this does not affect her eligibility since she qualifies under the smoker category. There are no exclusion criteria mentioned that would disqualify her." + }, + "NCT02213809": { + "matching_score": 0.0, + "agg_score": 0.0, + "trial_score": 0.0, + "qrels_score": 0, + "brief_summary": "Background:~COPD is an inflammatory and chronic obstructive lung disease, mainly caused by smoking. Most patients with COPD are discovered and treated in primary health care. Co-morbidity with heart disease, hypertension, diabetes, osteoporosis and underweight is common. It is important to diagnose COPD at an early stage, primarily to motivate smoking cessation, which is the most important factor for decelerating the progress of COPD. In addition, medication and rehabilitation to reduce symptoms of COPD can be given. Previous studies in Sweden have shown poor quality of primary health care provided to patients with COPD.~As general practitioners often deal with multiple medical problems and patients' motivation when diagnosing and treating COPD we hypothesize that case method education (see description under intervention) in COPD has better effect than traditional education (see description under intervention).This study aims to examine the effect of case method education on (1) learning in COPD among general practitioners and on (2) health in their patients with COPD.~Method:~Primary health care centers (PHCC) in Stockholm will be recruited. The PHCCs will be randomized to either case method education (n=9 PHCCs) or traditional education (n=9 PHCCs) in COPD for their general practitioners. The educations will be held during two times (two hours each) within a time range of three months, covering examination and treatment of patients with COPD. At least 10.000 patients should be listed at PHCCs included. Random sampling of 45 patients with COPD at stage 2-3 will be done from each PHCC. The patients will fill in a self-assessment questionnaire including CCQ, CAT and LINQ (see outcome measures) as well as questions about medication, exacerbations and other chronic diseases. The questionnaire will be sent to the patients 1-2 months before the education and 18 months after the education. Differences in assessments in the questionnaire before and after the education will be compared between the patients listed at the PHCCs that have received case method education vs. traditional education. In addition, general practitioners (approximately, n=180) at the PHCCs will fill in a questionnaire, immediately before and 12 months after the education, covering the learning outcomes in order to study differences in learning between the two intervention groups.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as she presents with symptoms and a history consistent with COPD, which is the target condition of the trial. Her significant smoking history and chronic respiratory symptoms strongly suggest COPD, which aligns with the trial's focus on patients with this condition. However, there is no explicit confirmation of a COPD diagnosis or spirometry results indicating GOLD grade 2-3, which are necessary for full relevance.", + "eligibility_explanation": "The patient likely has COPD due to her smoking history and symptoms, but there is no direct evidence of a COPD diagnosis or spirometry results indicating GOLD grade 2-3, which are required for eligibility. Without this information, we cannot confirm her eligibility for the trial." + } + } + }, + "sigir-201520": { + "patient_summary": "The patient is an 89-year-old man experiencing progressive cognitive and personality changes over six months, including memory loss, language difficulties, and unusual behaviors. He exhibits paratonic rigidity, myoclonic jerks, and brisk reflexes, with significant impairment in daily activities. The patient shows signs of disorientation, apraxia, and possible aphasia.", + "trials": { + "NCT00182832": { + "matching_score": 0.75, + "agg_score": 0.4, + "trial_score": 1.15, + "qrels_score": 2, + "brief_summary": "The purpose of this study is to evaluate the effectiveness of a cognitive screening program coupled with a computerized decision support system in improving the quality of care for hospitalized older adults with cognitive impairment.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as he is an older adult with cognitive impairment, which is the target condition of the study. The trial aims to improve care for hospitalized older adults with memory problems, and the patient exhibits significant cognitive impairment symptoms. However, there is no explicit mention of the patient being hospitalized in a medical ward, which is a key inclusion criterion.", + "eligibility_explanation": "The patient meets several inclusion criteria: he is over 65 years old, can speak English, and has cognitive impairment. There is no information suggesting he is excluded based on the exclusion criteria. However, the lack of explicit information about his hospitalization status in a medical ward limits his eligibility. Therefore, while he is relevant, his eligibility is uncertain due to this missing information." + }, + "NCT00880347": { + "matching_score": -0.5, + "agg_score": -0.4, + "trial_score": -0.9, + "qrels_score": 1, + "brief_summary": "The objective of the study is to define the performance of blood-based signatures for Alzheimer's Disease (AD) in different patients populations including AD, non-AD dementia, and non-demented controls.", + "relevance_explanation": "The patient is relevant to the clinical trial as he is an 89-year-old male with significant cognitive impairment, which aligns with the trial's focus on Alzheimer's Disease and other types of dementia. The trial aims to study blood-based signatures in patients with probable Alzheimer's Disease or other dementias, and the patient's symptoms and age make him a suitable candidate for this research.", + "eligibility_explanation": "The patient meets several inclusion criteria, such as being over 40 years old, providing informed consent, and being compliant with study procedures. However, there is no direct evidence of a clinical diagnosis of probable Alzheimer's Disease according to the specified criteria, and there is no evidence of brain imaging to confirm the diagnosis. Additionally, the presence of paratonic rigidity and myoclonic jerks may suggest other conditions, which could exclude him from the AD group. The patient is excluded from the non-AD demented group due to symptoms that may lead to reconsider the initial diagnosis of dementia. These factors significantly impact his eligibility." + } + } + }, + "sigir-201521": { + "patient_summary": "The patient is a 32-year-old male experiencing diarrhea, abdominal cramping, flatulence, greasy and foul-smelling stools, loss of appetite, and malaise. These symptoms began after a hiking trip where he consumed untreated water. A stool smear test revealed the presence of ellipsoidal cysts with smooth walls and 2+ nuclei, suggesting a parasitic infection.", + "trials": { + "NCT02105714": { + "matching_score": 0.5, + "agg_score": 0.35, + "trial_score": 0.85, + "qrels_score": 2, + "brief_summary": "NIDIAG is an international collaboration on integrated diagnosis-treatment platforms, funded by the European Commission (EC). NIDIAG aims to develop an improved, patient-centred system for delivering primary health care in resource-constrained settings. NIDIAG will investigate three clinical syndromes, namely (i) persistent digestive disorders, (ii) persistent fever and (iii) neurological disorders, due to neglected tropical diseases (NTDs). The current study focuses on persistent digestive disorders, which are defined as diarrhoea or abdominal pain that last for at least 2 weeks.~While acute diarrhoea has been studied globally, few research activities have focused on the epidemiology, diagnosis and treatment of long-lasting diarrhoeal episodes (2 weeks and longer) in the tropics. The spectrum of possibly involved pathogens includes more than 30 bacterial, parasitic and viral infectious agents. This lack of data may be explained by the fact that people suffering from NTDs might only seek care at a late stage of the disease. Furthermore, health systems in affected regions are often weak and their primary health-care centres are often under-staffed and lack essential diagnostic equipment.~The hypothesis of this study is that development of an evidence-based syndromic approach can lead to better diagnosis and management of NTDs in patients with persistent digestive disorders. The study will be carried out in two West African countries (C\u00f4te d'Ivoire and Mali) and in two Asian countries (Indonesia and Nepal). The study will follow a case-control design and patients and controls will be prospectively enrolled. In order to address the knowledge gaps, three specific objectives will be pursued. First, the contribution of NTDs to the 'persistent digestive disorders syndrome' will be assessed. Second, the value of clinical features and rapid diagnostic tests (RDTs) for the diagnosis of target NTDs that give rise to persistent digestive disorders will be determined. Third, the clinical response to standard empiric and targeted treatment of several NTDs in patients with persistent digestive disorders will be evaluated. These objectives will provide a long-term benefit for the communities by improving the clinical decision-making process for the target NTDs and thus, better diagnostic work-up and patient management can be achieved in the study countries and other similar resource-constrained countries", + "relevance_explanation": "The patient is relevant to the clinical trial as he presents with symptoms consistent with persistent digestive disorders, specifically diarrhea and abdominal cramping, which are target conditions of the trial. Additionally, the presence of ellipsoidal cysts in the stool suggests a parasitic infection, potentially giardiasis, which is one of the target conditions of the trial. However, the duration of the diarrhea is not specified, which is a critical factor for full relevance.", + "eligibility_explanation": "The patient meets the inclusion criterion of providing informed consent and does not meet any exclusion criteria, such as needing immediate intensive care or having clinical jaundice. However, the lack of information on the duration of diarrhea prevents full eligibility, as persistent diarrhea is defined as lasting for at least 2 weeks. Therefore, while the patient is not excluded, he cannot be fully confirmed as eligible without additional information on the duration of symptoms." + }, + "NCT01959048": { + "matching_score": -0.25, + "agg_score": -0.1, + "trial_score": -0.35, + "qrels_score": 0, + "brief_summary": "Clostridium difficile has become one of the leading causes of hospital acquired infections, and is associated with increased mortality. Patients with C. difficile associated disease (CDAD) possess deficiencies in 'normal' fecal microbial composition, most likely as a result of earlier antibiotic usage. The current standard of care treatment for severe C. difficile, which consists of antibiotics, does not restore the microbiota. Restoration of the normal colonic microbiota by fecal microbiota transplantation (FMT) may enable reversion colonic microbial population to a more 'normal'state and lead to cure.~A few patients develop severe CDAD which may be complicated by adynamic ileus, or toxic megacolon. The management in this context is based on limited data, and for some the only available option is sub-total colectomy.~Although FMT is by no means a new therapeutic modality, there is limited information on its use for the treatment of acute CDAD, including severe CDAD. Because of the high morbidity and mortality associated with treatment of patients with severe CDAD, and because the evidence supporting the current recommendations is weak and based upon the demonstration that FMT is an effective strategy to re-establish a balanced intestinal microbiota with resultant cure of recurrent CDAD, we propose to study the efficacy and safety of FMT for severe CDAD.~Patients with severe CDAD can be divided into two operational groups; those that have diarrhea and those that suffer from adynamic ileus. We propose to apply FMT through colonoscopy for all patients because current data suggest that the overall success rate of FMT for recurrent CDAD with lower gastrointestinal tract FMT was higher than FMT through the upper gastrointestinal tract. In addition, for patients with adynamic ileus and toxic megacolon (i.e., the population with the highest CDAD-associated morbidity and mortality), intra-colonic FMT administration is the preferred alternative.", + "relevance_explanation": "The patient is not relevant to the clinical trial as there is no indication of Clostridium difficile infection. The symptoms and stool analysis suggest a Giardia infection, which is unrelated to the trial's focus on severe CDAD. The trial is specifically targeting patients with confirmed severe CDAD, which the patient does not have.", + "eligibility_explanation": "The patient is ineligible for the trial because he does not have a confirmed diagnosis of severe CDAD, which is a primary inclusion criterion. Additionally, the presence of an alternative etiology for diarrhea (likely Giardia) excludes him from participation. While the patient meets some general inclusion criteria such as age and ability to consent, these are insufficient without the primary condition of interest." + } + } + }, + "sigir-201522": { + "patient_summary": "The patient is a 65-year-old male with a history of tuberculosis, presenting with a productive cough containing blood. Imaging shows a round opaque mass in a cavity in the left upper lobe, which moves with position changes. Sputum culture indicates the presence of a fungal organism with septated, low-angle branching hyphae.", + "trials": { + "NCT02534727": { + "matching_score": 0.8, + "agg_score": 0.6, + "trial_score": 1.4, + "qrels_score": 2, + "brief_summary": "Background:~Many people around the world get tuberculosis (TB) and non-tuberculous mycobacteria (NTM) infections. Sometimes medicine that treats these infections does not get to where the bacteria are in the lungs. Researchers want to find a way to tell if enough medicine is getting to where it is needed in the lungs. They will look at how much medicine is in your sputum (what you cough up) compared to how much is in your blood. They will also investigate a new test to quickly figure out what medicines are likely to treat TB effectively.~Objective:~To determine the relationship between the concentration of TB drugs in plasma and sputum over time.~Eligibility:~People ages 18 and older who have TB or NTM infection that is suspected to be drug resistant. They must be taking TB or NTM medicines.~Design:~Participants will be screened with medical history.~Participants will be in the study for 2 8 days.~Participants will give 3 or more sputum samples over at least 2 different days. They will cough sputum into a cup.~Participants will have blood drawn 4 times a day on 2 different days.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as he has a history of tuberculosis and ongoing symptoms of pulmonary TB, which are key target conditions of the trial. The trial aims to study the pharmacokinetics of TB drugs, and the patient is likely to be Mycobacterium culture positive, which aligns with the trial's objectives.", + "eligibility_explanation": "The patient meets most of the inclusion criteria: he is over 18, has a history of TB, shows ongoing symptoms, is likely Mycobacterium culture positive, and is willing to comply with the trial protocol. However, there is no information on whether he is taking anti-tuberculosis medicines or if there is suspected drug resistance, which are important criteria for full eligibility. There are no exclusion criteria that apply to him." + }, + "NCT01207128": { + "matching_score": 0.66667, + "agg_score": 0.2, + "trial_score": 0.86667, + "qrels_score": 2, + "brief_summary": "The purpose of this study is to evaluate the therapeutic effectiveness of combination antifungal therapy (CAT) of voriconazole plus micafungin versus voriconazole plus placebo equivalent as primary therapy for invasive aspergillosis (IA) in patients with hematological cancer.", + "relevance_explanation": "The patient is relevant to the clinical trial as he has a diagnosis of aspergillosis, which is the target condition of the trial. The presence of septated, low-angle branching hyphae in the sputum culture is indicative of Aspergillus species, aligning with the trial's focus on invasive aspergillosis. Additionally, the patient is willing to provide informed consent and is over 18 years of age, meeting some of the basic inclusion criteria.", + "eligibility_explanation": "The patient meets the inclusion criteria of providing informed consent and being over 18 years old. However, there is insufficient information regarding the Aspergillus GM index, which is crucial for confirming the diagnosis of invasive aspergillosis as per the trial's requirements. Additionally, there is no information on prior antifungal treatment duration, liver function tests, creatinine levels, or any other exclusion criteria that might disqualify the patient. Therefore, while the patient is not explicitly excluded, the lack of information on key eligibility criteria limits the ability to confirm full eligibility." + } + } + }, + "sigir-201523": { + "patient_summary": "An 18-year-old male presents with high fever, chills, facial flushing, epistaxis, severe headache, and joint pain after returning from Asia. Laboratory findings show leukopenia, increased hematocrit, and thrombocytopenia.", + "trials": { + "NCT02334514": { + "matching_score": 0.33333, + "agg_score": 0.2, + "trial_score": 0.53333, + "qrels_score": 2, + "brief_summary": "The purpose of this study is to determine the duration of viral shedding in hospitalized patients with influenza virus, treated with oseltamivir.", + "relevance_explanation": "The patient presents with symptoms such as sudden onset of high fever, headache, and joint pain, which are suggestive of influenza virus infection. These symptoms align with the clinical presentation required for the trial, making the patient relevant to the study. However, there is no confirmation of influenza via a PCR test, which is crucial for full relevance.", + "eligibility_explanation": "The patient meets the symptom-based inclusion criterion, suggesting potential influenza infection. However, there is no information on a positive PCR test for influenza or whether antiviral treatment was indicated, which are necessary for full eligibility. The patient does not meet any exclusion criteria, as he is not immune compromised, not pregnant, and there is no information on prior oseltamivir treatment. Therefore, the eligibility is limited by the lack of PCR confirmation and treatment indication." + }, + "NCT00084240": { + "matching_score": -1.0, + "agg_score": -0.6, + "trial_score": -1.6, + "qrels_score": 1, + "brief_summary": "The primary objective is to confirm the hypothesis that azithromycin (optimal dose once daily for three days) plus chloroquine is non-inferior to sulfadoxine-pyrimethamine plus chloroquine for the treatment of uncomplicated, symptomatic malaria due to P. falciparum.", + "relevance_explanation": "The patient presents with symptoms consistent with uncomplicated, symptomatic malaria, such as high fever and joint pain, which aligns with the trial's target condition of uncomplicated, symptomatic falciparum malaria. However, there is no confirmation of a positive blood smear or rapid diagnostic test for Plasmodium falciparum, which are critical for confirming relevance to the trial.", + "eligibility_explanation": "The patient is excluded due to the presence of leukopenia and thrombocytopenia, which are considered blood dyscrasias and are listed as exclusion criteria. Additionally, there is insufficient information to confirm the inclusion criteria, such as a positive blood smear or rapid diagnostic test for P. falciparum, and serum glucose levels." + } + } + }, + "sigir-201524": { + "patient_summary": "A 31-year-old male with no significant past medical history presents with a productive cough, chest pain, fever, and chills. Symptoms began with a cold one week ago, improved, then worsened with new fever and right-sided chest pain aggravated by coughing. Lung exam shows expiratory wheezing, decreased breath sounds, and egophony in the left lower lung field.", + "trials": { + "NCT00711399": { + "matching_score": 1.0, + "agg_score": 0.95, + "trial_score": 1.95, + "qrels_score": 2, + "brief_summary": "The study goal is to create a database of respiratory sounds recordings, to evaluate and validate the WIM technology and to evaluate the efficacy of a specific treatment by comparing the severity of the respiratory symptoms before and after the administration of the treatment.", + "relevance_explanation": "The patient is highly relevant to the clinical trial as he presents with respiratory symptoms, specifically a productive cough and wheezing, which are key conditions being studied in the trial. The trial aims to assess respiratory sounds, and the patient's symptoms align well with the trial's focus. Additionally, the patient is willing to provide informed consent and comply with the trial protocol, further supporting his relevance.", + "eligibility_explanation": "The patient meets all the inclusion criteria: he has a productive cough and is willing to provide informed consent. He does not meet any of the exclusion criteria: he does not have chest tubes, there are no skin lesions mentioned that would preclude sensor attachment, he is not in respiratory distress, and as a male, pregnancy is not applicable. Therefore, the patient is fully eligible for the trial." + }, + "NCT00540072": { + "matching_score": 0.58333, + "agg_score": 0.45, + "trial_score": 1.03333, + "qrels_score": 2, + "brief_summary": "A COMPARASON OF CIDECIN\u2122 (DAPTOMYCIN) TO ROCEPHIN\u00ae (CEFTRIAXONE) IN THE TREATMENT OF MODERATE TO SEVERE COMMUNITY-ACQUIRED ACUTE BACTERIAL PNEUMONIA DUE TO S. PNEUMONIAE", + "relevance_explanation": "The patient is highly relevant to the clinical trial as he presents with symptoms consistent with community-acquired bacterial pneumonia, which is the target condition of the trial. The patient exhibits a productive cough, fever, and chest pain, which align with the clinical symptoms required for the trial. Additionally, he is willing to provide informed consent and comply with the trial protocol.", + "eligibility_explanation": "The patient meets several inclusion criteria, such as being an adult male, having a productive cough, and exhibiting fever. However, there is insufficient information regarding a chest radiograph showing a new pulmonary infiltrate, which is a critical inclusion criterion. Additionally, there is no information on the patient's white blood cell count or hypoxemia status, which are also important for eligibility. The patient does not meet any exclusion criteria based on the available information." + } + } + } +} \ No newline at end of file diff --git a/results/trialgpt_checkpoint.txt b/results/trialgpt_checkpoint.txt new file mode 100644 index 0000000..0e2022e --- /dev/null +++ b/results/trialgpt_checkpoint.txt @@ -0,0 +1,5 @@ +Step 1 completed at 2025-01-28 16:54:47 (Duration: 176s) +Step 2 completed at 2025-01-28 16:54:53 (Duration: 6s) +Step 3 completed at 2025-01-28 17:05:57 (Duration: 106s) +Step 4 completed at 2025-01-28 17:13:06 (Duration: 173s) +Step 5 completed at 2025-01-28 17:13:09 (Duration: 3s) diff --git a/run_trialgpt_pipeline.sh b/run_trialgpt_pipeline.sh new file mode 100755 index 0000000..84d9853 --- /dev/null +++ b/run_trialgpt_pipeline.sh @@ -0,0 +1,190 @@ +#!/bin/bash + +: ' +TrialGPT Pipeline Overview: + +This script orchestrates the TrialGPT pipeline, a comprehensive system for matching patients to clinical trials using advanced AI techniques. + +Components and Workflow: + +1. TrialGPT-Retrieval: + a) Keyword Generation (trialgpt_retrieval/keyword_generation.py): + Generates search keywords for each patient description. + b) Hybrid Fusion Retrieval (trialgpt_retrieval/hybrid_fusion_retrieval.py): + Combines BM25 and MedCPT-based retrieval to find relevant clinical trials. + +2. TrialGPT-Matching (trialgpt_matching/run_matching.py): + Performs detailed matching between patients and retrieved trials. + +3. TrialGPT-Ranking: + a) Aggregation (trialgpt_ranking/run_aggregation.py): + Aggregates matching results to produce overall scores. + b) Final Ranking (trialgpt_ranking/rank_results.py): + Produces the final ranking of trials for each patient. + +Key Features: + +1. Modular Design: Each major component is separated, allowing for easier maintenance and future improvements. +2. AI Model Utilization: Leverages advanced language models (e.g., GPT-4) and specialized models like MedCPT. +3. Hybrid Approach: Combines traditional (BM25) and AI-based (MedCPT) methods for improved retrieval. +4. Checkpoint System: Tracks progress and allows for resumption of interrupted runs. +5. Configurability: Various parameters can be adjusted for experimentation and optimization. + +Technical Highlights: + +- Extensive use of NLP techniques for tokenization, embedding, and semantic matching. +- Integration with OpenAI API for leveraging large language models. +- Sophisticated data processing pipeline handling various formats and transformations. +- Performance optimization through batching in encoding and retrieval. +- Consideration of ethical aspects, including patient consent in descriptions. + +This pipeline represents a state-of-the-art approach to clinical trial matching, demonstrating the potential of AI to enhance efficiency and accuracy in this critical healthcare domain. +' +#TODO update above with "It be compatible with both GPT and Llama models" + +# Exit immediately if a command exits with a non-zero status +# set -e + +export PYTHONPATH="${PYTHONPATH}:$(pwd)" + +# Checkpoint file +CHECKPOINT_FILE="results/trialgpt_checkpoint.txt" + +# Function to measure execution time +measure_time() { + start_time=$(date +%s) + "$@" + end_time=$(date +%s) + duration=$((end_time - start_time)) + echo "Time taken: $duration seconds" + return $duration +} + +# Function to update checkpoint +update_checkpoint() { + local step=$1 + local duration=$2 + local timestamp=$(date "+%Y-%m-%d %H:%M:%S") + echo "Step $step completed at $timestamp (Duration: ${duration}s)" >> "$CHECKPOINT_FILE" +} + +# Function to get last completed step +get_last_step() { + if [ -f "$CHECKPOINT_FILE" ]; then + tail -n 1 "$CHECKPOINT_FILE" | cut -d' ' -f2 + else + echo "0" + fi +} + +# Set variables +CORPUS="sigir" #"sigir_small" "sigir_mini" +MODEL="gpt-4o" #"gpt-4o-mini" "gpt-4o" "Llama-3.2-3B-Instruct" "Llama-3.3-70B-Instruct" +QUANTIZE=true + +K=20 +BM25_WEIGHT=1 +MEDCPT_WEIGHT=1 + +#overwrites data for the sage, else resumes in the stage +OVER_WRITE=false #true #'true' + +# critical number, determines how many trials from retrieval to run on per patient +TOP_K=10 + +# batch size for the bert like retrieval model +BATCH_SIZE=512 + +# these two numbers below don't matter to the final score +#TODO: move them to TrialGPT/trialgpt_ranking/rank_results.py +ELIGIBILITY=0.0563 #0.0804 #0.0872 #0.1216 +EXCLUSION=0.0432 #0.05 #0.0530 #0.0931 + +# Set the number of GPUs based on the model +case $MODEL in + "gpt-4o-mini"|"gpt-4o") + NGPUS=0 # OpenAI models don't use local GPUs + QUANTIZE_ARG="" + CHECKPOINT_DIR="none" + ;; + "Llama-3.2-3B-Instruct") + NGPUS=1 + CHECKPOINT_DIR="../../models/Llama-3.2-3B-Instruct/" + QUANTIZE_ARG=$([ "$QUANTIZE" = true ] && echo "-q" || echo "") + #ls "$CHECKPOINT_DIR" + #echo "QUANTIZE_ARG $QUANTIZE_ARG" + ;; + "Llama-3.3-70B-Instruct") + NGPUS=4 + CHECKPOINT_DIR="../../models/Llama-3.3-70B-Instruct/" + QUANTIZE_ARG=$([ "$QUANTIZE" = true ] && echo "-q" || echo "") + #ls "$CHECKPOINT_DIR" + #echo "QUANTIZE_ARG $QUANTIZE_ARG" + ;; + *) + echo "Invalid model name. Exiting." + exit 1 + ;; +esac + +echo "Starting TrialGPT pipeline..." + +# Get the last completed step +LAST_STEP=$(get_last_step) + +# Step 1: TrialGPT-Retrieval - Keyword Generation +if [ "$LAST_STEP" -lt 1 ]; then + echo "Step 1: Keyword Generation" + measure_time python trialgpt_retrieval/keyword_generation.py -c $CORPUS -m $MODEL -g $NGPUS -d $CHECKPOINT_DIR $QUANTIZE_ARG + duration=$? + update_checkpoint "1" $duration +else + echo "Skipping Step 1: Keyword Generation Already completed" +fi + +# Step 2: TrialGPT-Retrieval - Hybrid Fusion Retrieval and Generate Retrieved Trials +if [ "$LAST_STEP" -lt 2 ]; then + echo "Step 2: Hybrid Fusion Retrieval and Generate Retrieved Trials" + measure_time python trialgpt_retrieval/hybrid_fusion_retrieval.py $CORPUS $MODEL $K $BM25_WEIGHT $MEDCPT_WEIGHT $OVER_WRITE $TOP_K $BATCH_SIZE $ELIGIBILITY $EXCLUSION + duration=$? + update_checkpoint "2" $duration +else + echo "Skipping Step 2: Hybrid Fusion Already completed" +fi + +# Step 3: TrialGPT-Matching +if [ "$LAST_STEP" -lt 3 ]; then + echo "Step 3: TrialGPT-Matching" + measure_time python trialgpt_matching/run_matching.py $CORPUS $MODEL $OVER_WRITE -g $NGPUS -d $CHECKPOINT_DIR $QUANTIZE_ARG + duration=$? + update_checkpoint "3" $duration +else + echo "Skipping Step 3: TrialGPT-Matching Already completed" +fi + +# Step 4: TrialGPT-Ranking - Aggregation +if [ "$LAST_STEP" -lt 4 ]; then + echo "Step 4: TrialGPT-Ranking Aggregation" + MATCHING_RESULTS="results/matching_results_${CORPUS}_${MODEL}.json" + measure_time python trialgpt_ranking/run_aggregation.py $CORPUS $MODEL $MATCHING_RESULTS $OVER_WRITE -g $NGPUS -d $CHECKPOINT_DIR $QUANTIZE_ARG + duration=$? + update_checkpoint "4" $duration +else + echo "Skipping Step 4: Aggregation Already completed" +fi + +# Step 5: TrialGPT-Ranking - Final Ranking +if [ "$LAST_STEP" -lt 5 ]; then + echo "Step 5: TrialGPT-Ranking Final Ranking" + MATCHING_RESULTS="results/matching_results_${CORPUS}_${MODEL}.json" + AGGREGATION_RESULTS="results/aggregation_results_${CORPUS}_${MODEL}.json" + measure_time python trialgpt_ranking/rank_results.py $MATCHING_RESULTS $AGGREGATION_RESULTS $OVER_WRITE $CORPUS $MODEL + duration=$? + update_checkpoint "5" $duration +else + echo "Skipping Step 5: Final Ranking Already completed" +fi + +echo "TrialGPT pipeline completed successfully!" +echo "Checkpoint file contents:" +cat "$CHECKPOINT_FILE" diff --git a/setup_trialgpt_env.sh b/setup_trialgpt_env.sh new file mode 100644 index 0000000..9cf8481 --- /dev/null +++ b/setup_trialgpt_env.sh @@ -0,0 +1,69 @@ +#!/bin/bash + +# Exit immediately if a command exits with a non-zero status +# set -e +# how to run with log file below command +# clear && source setup_trialgpt_env.sh |& tee log_build_trialgpt_env.txt + +# Name of the new Conda environment +ENV_NAME="trialgpt_env" + +# Check if the environment exists and remove it +if conda env list | grep -q "^$ENV_NAME "; then + echo "Environment $ENV_NAME exists. Removing it..." + conda deactivate + conda env remove -n $ENV_NAME -y +fi + +# Create a new Conda environment with Python 3.12 +echo "Creating new environment: $ENV_NAME" +conda create -n $ENV_NAME python=3.12 -y + +# Activate the new environment +echo "Activating environment: $ENV_NAME" +source activate $ENV_NAME + +# Function to clone repository if it doesn't exist +clone_if_not_exists() { + if [ ! -d "$1" ]; then + echo "Cloning repository: $1" + git clone "https://github.com/$1.git" + else + echo "Repository $1 already exists. Skipping clone." + echo "If you want to update the repository, consider running 'git pull' in the $1 directory." + fi +} + +# Clone TrialGPT repository if it doesn't exist +#clone_if_not_exists "ncbi-nlp/TrialGPT" + +# Install build essentials and common data science packages +echo "Installing build essentials and common packages..." +conda install -y gcc_linux-64 gxx_linux-64 numpy==1.26.4 pandas==2.2.2 pyspark==3.5.3 scikit-learn==1.5.2 jupyterlab matplotlib scipy seaborn plotly ipywidgets nbconvert pyarrow + +# Install PyTorch with CUDA support, torchvision, torchaudio, and faiss-gpu +echo "Installing PyTorch ecosystem..." +conda install pytorch==2.4.1 torchvision==0.19.1 torchaudio==2.4.1 pytorch-cuda=12.4 -c pytorch -c nvidia -y +conda install -c pytorch -c nvidia faiss-gpu=1.9.0 -y +echo "PyTorch installation complete" + +# Install additional required packages +echo "Installing additional packages..." +pip install transformers==4.48.1 nltk==3.8.1 openai==1.59.7 rank_bm25==0.2.2 accelerate bitsandbytes tqdm==4.67.1 + +echo "" +echo "Environment $ENV_NAME has been created and packages have been installed." +echo "To activate the environment, use: conda activate $ENV_NAME" +echo "Remember to set up your OpenAI API environment variables:" +echo 'export OPENAI_API_KEY="sk-proj-"' +echo "" +echo "To start JupyterLab, activate the environment and run:" +echo "jupyter lab" + +# The following block is commented out as the conda installs above cover all current requirements including PyTorch GPU support +: <<'END_COMMENT' +# TrialGPT specific setup (not needed with current conda installs) +# TRIALGPT_DIR="./TrialGPT" +# cd $TRIALGPT_DIR || { echo "Failed to change to TrialGPT directory"; exit 1; } +# pip install -r requirements.txt +END_COMMENT \ No newline at end of file diff --git a/testllama.py b/testllama.py new file mode 100644 index 0000000..b3ac3bf --- /dev/null +++ b/testllama.py @@ -0,0 +1,121 @@ +import torch +import transformers +from transformers import AutoModelForCausalLM, AutoTokenizer, BitsAndBytesConfig + +model_id = "../../models/Llama-3.3-70B-Instruct/" + +def create_llama_device_map(num_gpus, first_weight=1.0, last_weight=1.0): + if num_gpus < 2: + raise ValueError("Number of GPUs must be at least 2") + + # Calculate the number of layers to distribute + distributable_layers = 77 # 79 total layers minus the first and last layers + + # Calculate weights for middle GPUs + middle_gpus = num_gpus - 2 + middle_weight = (num_gpus - first_weight - last_weight) / middle_gpus if middle_gpus > 0 else 0 + + # Calculate layers per GPU + layers_per_gpu = [ + max(1, round(first_weight * distributable_layers / num_gpus)), # First GPU + *[max(1, round(middle_weight * distributable_layers / num_gpus)) for _ in range(middle_gpus)], # Middle GPUs + max(1, round(last_weight * distributable_layers / num_gpus)) # Last GPU + ] + + # Adjust to ensure total is correct + while sum(layers_per_gpu) < distributable_layers: + layers_per_gpu[layers_per_gpu.index(min(layers_per_gpu))] += 1 + while sum(layers_per_gpu) > distributable_layers: + layers_per_gpu[layers_per_gpu.index(max(layers_per_gpu))] -= 1 + + # Create the device map + device_map = { + "model.embed_tokens": 0, + "model.layers.0": 0, + "model.layers.1": 0, + } + + current_gpu = 0 + current_layer = 2 + for gpu, layer_count in enumerate(layers_per_gpu): + for _ in range(layer_count): + if current_layer < 78: + device_map[f"model.layers.{current_layer}"] = gpu + current_layer += 1 + + # Assign the last layers and components to the last GPU + last_gpu = num_gpus - 1 + device_map.update({ + "model.layers.78": last_gpu, + "model.layers.79": last_gpu, + "model.norm": last_gpu, + "model.rotary_emb": last_gpu, + "lm_head": last_gpu + }) + + return device_map + +# Example usage: +num_gpus = 4 +first_weight = .85 #0.79 #0.8 # Slightly less weight to the first GPU due to embed_tokens +last_weight = .93 #0.85 #0.6 # less weight to the last GPU due to norm, rotary_emb, lm_head + +device_map = create_llama_device_map(num_gpus, first_weight, last_weight) + +# Print the device map +# for key, value in device_map.items(): +# print(f"{key}: GPU {value}") + +# Set up BitsAndBytes configuration +quantization_config = BitsAndBytesConfig(load_in_8bit=True) + +# Load the model with quantization +model = AutoModelForCausalLM.from_pretrained( + model_id, + device_map=device_map, + torch_dtype=torch.bfloat16, + quantization_config=quantization_config +) + +# Print the model's structure +print(model) + +# Print layer names +# print("\nLayer names:") +# for name, _ in model.named_modules(): +# print(name) + +# Load the tokenizer +tokenizer = AutoTokenizer.from_pretrained(model_id) + +# Create the pipeline with the quantized model +pipeline = transformers.pipeline( + "text-generation", + model=model, + tokenizer=tokenizer, + device_map=device_map, + return_full_text=False +) + +# Your messages +messages = [ + {"role": "system", "content": "You are a pirate chatbot who always responds in pirate speak!"}, + {"role": "user", "content": "Who are you?"}, + {"role": "assistant", "content": """Yer lookin' fer a swashbucklin' chatbot, eh? Well, matey, I be Captain Chatbeard, the scurviest pirate to ever sail the seven seas... er, internets! Yer can call me Cap'n Chatbeard fer short. I be here to help ye navigate through the choppy waters o' knowledge, and mayhap even share a tale or two o' me own adventures on the high seas! So hoist the colors, me hearty, and let's set sail fer a treasure trove o' conversation!"""}, + {"role": "user", "content": """project has undergone a comprehensive overhaul, resulting in a sophisticated clinical trial matching system that leverages cutting-edge AI and NLP techniques. This extensive update refines and optimizes core components including hybrid fusion retrieval, keyword generation, patient-trial matching, and score aggregation, while ensuring seamless compatibility with both GPT and Llama models. The developers tackled significant challenges in prompt engineering, error handling, and performance optimization, striking a delicate balance between efficiency and accuracy. New features include detailed progress tracking, comprehensive error logging, and flexible model selection, all implemented with a keen awareness of medical data sensitivity. The system now boasts advanced ranking algorithms, multi-model AI integration, and a modular, maintainable codebase adaptable to evolving AI technologies. Optimizations span from low-level system enhancements, such as custom device mapping for large language models, to high-level improvements in user interface and output formatting. Extensive documentation, restructured code, and new utility functions enhance long-term viability and collaboration potential. Iterative development has yielded substantial improvements in token efficiency, prompt clarity, and complex medical terminology handling. The final development phase focused on refining AI prompts, crucial for interfacing between models and medical data. This project showcases AI's potential in healthcare, particularly for accelerating clinical trial recruitment and improving patient outcomes. Throughout development, the team maintained a real-world applicability in medical research. The TrialGPT system now stands as a testament to interdisciplinary collaboration between AI technology and medical expertise, representing a significant leap forward in clinical trial matching capabilities?"""}, + {"role": "assistant", "content": """Arrr, ye be wantin' to know about the TrialGPT project, eh? Alright then, matey, let me break it down fer ye. It seems they've given the whole system a right proper overhaul, addin' in all sorts o' fancy AI and NLP tricks. They've tweaked and polished all the important bits, like how it finds and matches trials, and how it scores and ranks 'em. And they've made sure it works smooth as silk with them GPT and Llama models, savvy?They've had to navigate through some treacherous waters, like gettin' the prompts just right, and dealin' with errors, but they've managed to find a good balance between bein' fast and bein' accurate. Now they've added all sorts o' new features, like trackin' progress, loggin' errors, and bein' able to choose which model to use. And they've made sure the whole thing is modular, so it can grow and change with the AI tech.They've worked on all sorts o' optimizations, from the nitty-gritty details like custom device mappings, to the big picture stuff like the user interface. And they've written it all down in nice, neat documentation, so others can use it and build on it. The team's been workin' hard to make sure it's all ethical and private, especially when it comes to medical data.So hoist the colors, me hearty, and take a gander at the TrialGPT system! It be a mighty fine example o' what can happen when AI and medical expertise come together, and it's a big step forward in helpin' get patients into clinical trials and gettin' 'em the help they need. Fair winds and following seas to the whole team, I says!"""}, + {"role": "user", "content": """ye'please write this in the voice of an commite'r for the pull request about what this merge request is's, was's, and is be's?"""}, + {"role": "assistant", "content": """**Merge Request: TrialGPT System Overhaul**Ahoy, matey! I be reviewin' the merge request fer the TrialGPT system overhaul, and I be here to give ye the lowdown.**What it was:**The ol' TrialGPT system be a clinical trial matchin' system that be needin' a good swabbin' to keep up with the latest AI and NLP tech. It be strugglin' to keep pace with the demandin' clinical trial landscape, and it be showin' its age.**What it's:**The new and improved TrialGPT system be a sophistocated clinical trial matchin' system that be leveragin' the latest AI and NLP techniques. It be boastin' a hybrid fusion retrieval system, keyword generation, patient-trial matchin', and score aggregation, all workin' together like a well-oiled machine. It be compatible with both GPT and Llama models, and it be showin' a keen awareness o' medical data sensitivity.**What it be:**The future o' the TrialGPT system be bright, me hearty! With its advanced rankin' algorithms, multi-model AI integration, and modular codebase, it be poised to take on the challenges o' clinical trial recruitment and patient outcomes. The team be committed to ethical considerations, data privacy, and real-world applicability, so ye can trust that the system be designed with the best interests o' patients and medical research in mind.**Key Changes:*** Comprehensive overhaul o' the system, includin' a new hybrid fusion retrieval system and keyword generation* Advanced rankin' algorithms and multi-model AI integration* Modular codebase and custom device mappings fer large language models* Improved user interface and output formatting* Enhanced error loggin' and progress trackin'* Flexible model selection and seamless compatibility with GPT and Llama models**Why it be important:**This merge request be important because it represents a significant leap forward in clinical trial matchin' capabilities. The TrialGPT system be designed to accelerate clinical trial recruitment and improve patient outcomes, and it be a testament to the power o' interdisciplinary collaboration between AI tech and medical expertise.So hoist the colors, me hearty, and let's set sail fer a review o' the code! I be lookin' forward to seein' the impact o' this merge request on the clinical trial landscape. Fair winds and followin' seas to the whole team!"""}, + {"role": "user", "content": """What do you think of Given the consistent pattern we've seen and the details of the dataset GPT-4 predictions were likely used to assist in the creation of the expert labels in the TrialGPT-Criterion-Annotations dataset. Initial GPT-4 Labeling: probably ran GPT-4 on the entire dataset first to generate initial eligibility predictions. Expert Review Process: Human experts then reviewed these GPT-4 predictions, but instead of labeling from scratch, they likely used the GPT-4 predictions as a starting point. In this review process, experts might have been more likely to agree with GPT-4's predictions unless they saw a clear reason to disagree. This could be due to anchoring bias or simply to save time. Experts probably focused more on correcting obvious errors, while potentially overlooking more subtle cases where they might have labeled differently if starting from scratch. In cases of uncertainty, experts might have been inclined to document their reasoning in a way that aligns with GPT-4's explanation, inadvertently reinforcing its decisions. This process would result in a dataset where the "expert" labels are highly correlated with GPT-4-turbo predictions, not necessarily because GPT-4-turbo is that accurate, but because the expert labels were influenced by GPT-4-turbo from the start. The 89% F1 score then reflects not just model performance, but the degree of alignment between GPT-4 and the expert review process that it helped shape. hypothesis independent models (GPT-4o and llama70b) show significantly lower performance when tested against these labels – they're essentially being compared against a GPT-4-turbo-influenced gold standard"""}, +] + +response = pipeline(messages, + max_new_tokens=2856, + do_sample=False, + temperature=None, + top_p=None) +result = response[0]['generated_text'] + +print(result) + + diff --git a/testoai.py b/testoai.py new file mode 100644 index 0000000..304a65c --- /dev/null +++ b/testoai.py @@ -0,0 +1,18 @@ +from openai import OpenAI +client = OpenAI() + +import nltk +nltk.download('punkt') + +completion = client.chat.completions.create( + model="gpt-4o-mini", + messages=[ + {"role": "system", "content": "You are a helpful assistant."}, + { + "role": "user", + "content": "Write a haiku about recursion in programming." + } + ] +) + +print(completion.choices[0].message) \ No newline at end of file diff --git a/trialgpt_matching/TrialGPT.py b/trialgpt_matching/TrialGPT.py index fe2ecbc..f99bbca 100644 --- a/trialgpt_matching/TrialGPT.py +++ b/trialgpt_matching/TrialGPT.py @@ -5,114 +5,269 @@ """ import json -from nltk.tokenize import sent_tokenize -import time import os +import sys -from openai import AzureOpenAI +# Add the project root directory to the Python path +sys.path.append(os.path.dirname(os.path.dirname(os.path.abspath(__file__)))) -client = AzureOpenAI( - api_version="2023-09-01-preview", - azure_endpoint=os.getenv("OPENAI_ENDPOINT"), - api_key=os.getenv("OPENAI_API_KEY"), -) +from common.utils import generate_response -def parse_criteria(criteria): - output = "" - criteria = criteria.split("\n\n") - - idx = 0 - for criterion in criteria: - criterion = criterion.strip() - if "inclusion criteria" in criterion.lower() or "exclusion criteria" in criterion.lower(): - continue +def parse_criteria(criteria: str) -> str: + """ + Parse and format a specific set of clinical trial criteria (either inclusion or exclusion). - if len(criterion) < 5: - continue - - output += f"{idx}. {criterion}\n" - idx += 1 - - return output + This function takes a string containing either inclusion or exclusion criteria + for a clinical trial and formats it into a numbered list. It removes any header + mentioning "inclusion criteria" or "exclusion criteria" and skips empty or very short lines. + + Args: + criteria (str): A string containing either inclusion or exclusion criteria. + + Returns: + str: A formatted string with numbered criteria, excluding headers and empty lines. + + Example: + Input: + ''' + Inclusion Criteria: + + - Age 18 or older + - Diagnosed with Type 2 Diabetes + ''' + + Output: + ''' + 0. Age 18 or older + 1. Diagnosed with Type 2 Diabetes + ''' + """ + output = "" + + # Split the criteria into separate lines + criteria_lines = criteria.split("\n\n") + + idx = 0 + for line in criteria_lines: + # Remove leading/trailing whitespace from each line + line = line.strip() + + # Skip the header line + if "inclusion criteria" in line.lower() or "exclusion criteria" in line.lower(): + continue + + # Skip lines that are too short (likely empty or irrelevant) + if len(line) < 5: + continue + + # Add the formatted criterion to the output + output += f"{idx}. {line}\n" + idx += 1 + + return output def print_trial( - trial_info: dict, - inc_exc: str, + trial_info: dict, + inc_exc: str, ) -> str: - """Given a dict of trial information, returns a string of trial.""" - - trial = f"Title: {trial_info['brief_title']}\n" - trial += f"Target diseases: {', '.join(trial_info['diseases_list'])}\n" - trial += f"Interventions: {', '.join(trial_info['drugs_list'])}\n" - trial += f"Summary: {trial_info['brief_summary']}\n" - - if inc_exc == "inclusion": - trial += "Inclusion criteria:\n %s\n" % parse_criteria(trial_info['inclusion_criteria']) - elif inc_exc == "exclusion": - trial += "Exclusion criteria:\n %s\n" % parse_criteria(trial_info['exclusion_criteria']) + """Given a dict of trial information, returns a string of trial.""" + + trial = f"Title: {trial_info['brief_title']}\n" + trial += f"Target diseases: {', '.join(trial_info['diseases_list'])}\n" + trial += f"Interventions: {', '.join(trial_info['drugs_list'])}\n" + trial += f"Summary: {trial_info['brief_summary']}\n" + + if inc_exc == "inclusion": + trial += "Inclusion criteria:\n %s\n" % parse_criteria(trial_info['inclusion_criteria']) + elif inc_exc == "exclusion": + trial += "Exclusion criteria:\n %s\n" % parse_criteria(trial_info['exclusion_criteria']) - return trial + return trial def get_matching_prompt( - trial_info: dict, - inc_exc: str, - patient: str, -) -> str: - """Output the prompt.""" - prompt = f"You are a helpful assistant for clinical trial recruitment. Your task is to compare a given patient note and the {inc_exc} criteria of a clinical trial to determine the patient's eligibility at the criterion level.\n" - - if inc_exc == "inclusion": - prompt += "The factors that allow someone to participate in a clinical study are called inclusion criteria. They are based on characteristics such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.\n" - - elif inc_exc == "exclusion": - prompt += "The factors that disqualify someone from participating are called exclusion criteria. They are based on characteristics such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.\n" - - prompt += f"You should check the {inc_exc} criteria one-by-one, and output the following three elements for each criterion:\n" - prompt += f"\tElement 1. For each {inc_exc} criterion, briefly generate your reasoning process: First, judge whether the criterion is not applicable (not very common), where the patient does not meet the premise of the criterion. Then, check if the patient note contains direct evidence. If so, judge whether the patient meets or does not meet the criterion. If there is no direct evidence, try to infer from existing evidence, and answer one question: If the criterion is true, is it possible that a good patient note will miss such information? If impossible, then you can assume that the criterion is not true. Otherwise, there is not enough information.\n" - prompt += f"\tElement 2. If there is relevant information, you must generate a list of relevant sentence IDs in the patient note. If there is no relevant information, you must annotate an empty list.\n" - prompt += f"\tElement 3. Classify the patient eligibility for this specific {inc_exc} criterion: " - - if inc_exc == "inclusion": - prompt += 'the label must be chosen from {"not applicable", "not enough information", "included", "not included"}. "not applicable" should only be used for criteria that are not applicable to the patient. "not enough information" should be used where the patient note does not contain sufficient information for making the classification. Try to use as less "not enough information" as possible because if the note does not mention a medically important fact, you can assume that the fact is not true for the patient. "included" denotes that the patient meets the inclusion criterion, while "not included" means the reverse.\n' - elif inc_exc == "exclusion": - prompt += 'the label must be chosen from {"not applicable", "not enough information", "excluded", "not excluded"}. "not applicable" should only be used for criteria that are not applicable to the patient. "not enough information" should be used where the patient note does not contain sufficient information for making the classification. Try to use as less "not enough information" as possible because if the note does not mention a medically important fact, you can assume that the fact is not true for the patient. "excluded" denotes that the patient meets the exclusion criterion and should be excluded in the trial, while "not excluded" means the reverse.\n' - - prompt += "You should output only a JSON dict exactly formatted as: dict{str(criterion_number): list[str(element_1_brief_reasoning), list[int(element_2_sentence_id)], str(element_3_eligibility_label)]}." - - user_prompt = f"Here is the patient note, each sentence is led by a sentence_id:\n{patient}\n\n" - user_prompt += f"Here is the clinical trial:\n{print_trial(trial_info, inc_exc)}\n\n" - user_prompt += f"Plain JSON output:" - - return prompt, user_prompt - - -def trialgpt_matching(trial: dict, patient: str, model: str): - results = {} - - # doing inclusions and exclusions in separate prompts - for inc_exc in ["inclusion", "exclusion"]: - system_prompt, user_prompt = get_matching_prompt(trial, inc_exc, patient) - - messages = [ - {"role": "system", "content": system_prompt}, - {"role": "user", "content": user_prompt}, - ] - - response = client.chat.completions.create( - model=model, - messages=messages, - temperature=0, - ) - - message = response.choices[0].message.content.strip() - message = message.strip("`").strip("json") - - try: - results[inc_exc] = json.loads(message) - except: - results[inc_exc] = message - - return results + trial_info: dict, + inc_exc: str, + patient: str, +) -> tuple[str, str]: + """Generate the system and user prompts for clinical trial matching.""" + + # System prompt: Define the assistant's role and task + system_prompt = f""" +You are a helpful assistant for clinical trial recruitment. Your task is to compare a given patient note +and the {inc_exc} criteria of a clinical trial to determine the patient's eligibility at the criterion level. +Prioritize accuracy and relevance in your analysis. +""" + + # Add inclusion/exclusion-specific context + if inc_exc == "inclusion": + system_prompt += """ +Inclusion criteria are the factors that allow someone to participate in a clinical study. +They are based on characteristics such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. +""" + elif inc_exc == "exclusion": + system_prompt += """ +Exclusion criteria are the factors that disqualify someone from participating in a clinical study. +They are based on characteristics such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. +""" + + # Add task-specific instructions + system_prompt += f""" +For each {inc_exc} criterion, you should perform the following steps: +1. **Reasoning**: Determine if the criterion is applicable to the patient. If applicable, check if the patient note contains direct evidence. + If no direct evidence is found, infer from existing evidence and decide if the criterion is likely true or false. + If the criterion is not mentioned and is medically important, assume it is not true for the patient. +2. **Relevant Sentences**: Identify the sentence IDs (example:<2.> or <13.>)in the patient note that are relevant to the criterion. If no relevant information is found, return an empty list. +3. **Eligibility Label**: Classify the patient's eligibility for the {inc_exc} criterion using one of the following labels: +""" + + # Add inclusion/exclusion-specific labels + if inc_exc == "inclusion": + system_prompt += """ + - "not applicable": The criterion is not relevant to the patient. + - "not enough information": The patient note lacks sufficient information to make a determination. + - "included": The patient meets the inclusion criterion. + - "not included": The patient does not meet the inclusion criterion. +""" + elif inc_exc == "exclusion": + system_prompt += """ + - "not applicable": The criterion is not relevant to the patient. + - "not enough information": The patient note lacks sufficient information to make a determination. + - "excluded": The patient meets the exclusion criterion and should be excluded from the trial. + - "not excluded": The patient does not meet the exclusion criterion. +""" + + # Add JSON output instructions with an emphasized "notes" field + system_prompt += """ +### Output Instructions: +- **Provide ONLY a valid JSON object** with the following structure: +```json +{ + "criterion_number": [ + "brief_reasoning", + [sentence_id_1, sentence_id_2, ...], + "eligibility_label" + ], + "criterion_number": [ + ... + ] +} +``` +- **Do NOT include any text outside of the JSON object.** This means no explanations, headers, or footers outside the JSON. + +### Example Output: +```json +{ + "0": [ + "The patient is...", + [2], + "included" + ], + "1": [ + "The patient has...", + [3, 5], + "excluded" + ] +} +``` +""" + + # User prompt: Provide the patient note and trial criteria + user_prompt = f""" +Here is the patient note, with each sentence labeled by a sentence ID: +{patient} + +Here is the clinical trial {inc_exc} criteria: +{print_trial(trial_info, inc_exc)} + +Please analyze the information and provide the JSON output as described above. +""" + + return system_prompt, user_prompt + +def trialgpt_match(trial: dict[str, any], patient: str, model: str, model_type: str, model_instance: any) -> dict[ + str, any]: + """ + Match a patient to a clinical trial using GPT-based analysis. + + This function evaluates a patient's eligibility for a clinical trial by analyzing + both inclusion and exclusion criteria against the patient's information. It uses + a specified language model to perform the analysis and generates detailed results. + + Args: + trial (dict[str, any]): A dictionary containing clinical trial information. + patient (str): A string containing the patient's medical information. + model (str): The specific GPT model name (for OpenAI models). + model_type (str): Either 'gpt' or 'llama'. + model_instance: Either an OpenAI client or a Llama pipeline. + + + Returns: + dict[str, any]: A dictionary containing the matching results for both + inclusion and exclusion criteria. + + Side Effects: + - Writes debug information to a JSON file named "results/messages_TrialGPT.json". + - Creates the file if it doesn't exist, or appends to it if it does. + + Note: + This function relies on external utility functions like `get_matching_prompt` + and `generate_response`, which should be imported or defined elsewhere in the script. + """ + # Initialize the results dictionary + results = {} + + # Define the debug file path + debug_filename = f"results/messages_TrialGPT.json" + + # Read existing debug data or create an empty list + if os.path.exists(debug_filename): + with open(debug_filename, 'r') as f: + try: + debug_data = json.load(f) + except json.JSONDecodeError: + debug_data = [] + else: + debug_data = [] + + # Iterate over inclusion and exclusion criteria + for inc_exc in ["inclusion", "exclusion"]: + # Generate prompts for the current criteria type + system_prompt, user_prompt = get_matching_prompt(trial, inc_exc, patient) + + # Prepare messages for the model + messages = [ + {"role": "system", "content": system_prompt}, + {"role": "user", "content": user_prompt}, + ] + + # Generate a response using the specified model + message = generate_response(model_type, model_instance, messages, model) + + # Clean up the response by removing potential markdown code block syntax + message = message.strip("`").strip("json") + + # Prepare the debug entry for this iteration + debug_entry = { + "type": inc_exc, + "system_prompt": system_prompt, + "user_prompt": user_prompt, + "response": message + } + debug_data.append(debug_entry) + + # Parse the model's response and store it in the results + try: + results[inc_exc] = json.loads(message) + except json.JSONDecodeError: + # If JSON parsing fails, store the raw message + results[inc_exc] = message + + #TODO: make debug optional, would be slow for production datasets + # Write the updated debug data back to the file + with open(debug_filename, 'w') as f: + json.dump(debug_data, f, indent=4) + + return results \ No newline at end of file diff --git a/trialgpt_matching/__init__.py b/trialgpt_matching/__init__.py new file mode 100644 index 0000000..70c622e --- /dev/null +++ b/trialgpt_matching/__init__.py @@ -0,0 +1,27 @@ +# trialgpt_matching/__init__.py +import os +import sys + +# Add the project root directory to the Python path +sys.path.append(os.path.dirname(os.path.dirname(os.path.abspath(__file__)))) + +from .TrialGPT import ( + parse_criteria, + print_trial, + get_matching_prompt, + trialgpt_match +) + +from .run_matching import ( + parse_arguments, + main +) + +__all__ = [ + 'parse_criteria', + 'print_trial', + 'get_matching_prompt', + 'trialgpt_match', + 'parse_arguments', + 'main' +] \ No newline at end of file diff --git a/trialgpt_matching/run_matching.py b/trialgpt_matching/run_matching.py index f4391d4..40463ea 100644 --- a/trialgpt_matching/run_matching.py +++ b/trialgpt_matching/run_matching.py @@ -1,61 +1,128 @@ +# TrialGPT/trialgpt_matching/run_matching.py + __author__ = "qiao" """ Running the TrialGPT matching for three cohorts (sigir, TREC 2021, TREC 2022). """ +import argparse import json -from nltk.tokenize import sent_tokenize import os import sys -from TrialGPT import trialgpt_matching +from nltk.tokenize import sent_tokenize +from tqdm import tqdm + +from TrialGPT import trialgpt_match + +# Add the project root directory to the Python path +sys.path.append(os.path.dirname(os.path.dirname(os.path.abspath(__file__)))) + +from common.utils import setup_model + +def parse_arguments(): + """Parse and validate command-line arguments.""" + parser = argparse.ArgumentParser(description="Run TrialGPT matching for specified corpus and model.") + parser.add_argument("corpus", help="Corpus name") + parser.add_argument("model", help="Model to use for matching") + parser.add_argument("overwrite", help="Overwrite existing results (true/false)") + parser.add_argument("-g", "--num_gpus", help="The number of GPUs to use for model distribution") + parser.add_argument("-d", "--checkpoint_dir", help="Checkpoint directory for Llama models") + parser.add_argument("-q", "--quantize", action="store_true", help="Use 8-bit quantization for Llama models") + return parser.parse_args() + + +def main(args): + dataset = json.load(open(f"results/retrieved_trials.json")) + output_path = f"results/matching_results_{args.corpus}_{args.model}.json" + failed_output_path = f"results/failed_matching_results_{args.corpus}_{args.model}.json" + + # Set up the model once before the main processing loop + model_type, model_instance = setup_model(args.model, args.num_gpus, args.checkpoint_dir, args.quantize) + + # Dict{Str(patient_id): Dict{Str(label): Dict{Str(trial_id): Str(output)}}} + if args.overwrite.lower() == 'true' or not os.path.exists(output_path): + print(f"Creating new matching results for {args.corpus} with {args.model}") + output = {} + else: + print(f"Loading existing matching results for {args.corpus} with {args.model}") + output = json.load(open(output_path)) + + failed_outputs = {} + + # Outer progress bar for patients + for instance in tqdm(dataset, desc="Processing patients", unit="patient"): + patient_id = instance["patient_id"] + patient = instance["patient"] + # already done in the data set from load_and_format_patient_descriptions(corpus) + # sents = sent_tokenize(patient) + # sents.append( + # "The patient will provide informed consent, and will comply with the trial protocol without any practical issues.") + # sents = [f"<{idx}.> {sent}" for idx, sent in enumerate(sents)] + # patient = "\n".join(sents) + + + if patient_id not in output: + output[patient_id] = {"0": {}, "1": {}, "2": {}} + + # Middle progress bar for labels + #TODO: remove the 2 1 0 loop its irrelevant at this stage, but must be removed throughout at the same time. + for label in tqdm(["2", "1", "0"], desc=f"Labels for patient {patient_id}", leave=False): + if label not in instance: continue + + # Inner progress bar for trials + for trial in tqdm(instance[label], desc=f"Trials for label {label}", leave=False): + trial_id = trial["NCTID"] + + if args.overwrite.lower() != 'true' and trial_id in output[patient_id][label]: + continue + + try: + results = trialgpt_match( + trial, + patient, + args.model, + model_type, + model_instance + ) + output[patient_id][label][trial_id] = results + + # Save after each trial to ensure progress is not lost + with open(output_path, "w") as f: + json.dump(output, f, indent=4) + + except Exception as e: + error_message = f"Error processing trial {trial_id} for patient {patient_id}: {str(e)}" + print(error_message) + if patient_id not in failed_outputs: + failed_outputs[patient_id] = {} + if label not in failed_outputs[patient_id]: + failed_outputs[patient_id][label] = {} + failed_outputs[patient_id][label][trial_id] = { + "error": str(e), + "patient": patient, + "trial": trial + } + + # Save failed outputs after each error + with open(failed_output_path, "w") as f: + json.dump(failed_outputs, f, indent=4) + + continue + + print(f"Matching results saved to {output_path}") + print(f"Failed matching results saved to {failed_output_path}") + + # Print summary + total_processed = sum( + sum(len(label_data) for label_data in patient_data.values()) for patient_data in output.values()) + total_failed = sum( + sum(len(label_data) for label_data in patient_data.values()) for patient_data in failed_outputs.values()) + print(f"Total trials processed: {total_processed + total_failed}") + print(f"Successful trials: {total_processed}") + print(f"Failed trials: {total_failed}") if __name__ == "__main__": - corpus = sys.argv[1] - model = sys.argv[2] - - dataset = json.load(open(f"dataset/{corpus}/retrieved_trials.json")) - - output_path = f"results/matching_results_{corpus}_{model}.json" - - # Dict{Str(patient_id): Dict{Str(label): Dict{Str(trial_id): Str(output)}}} - if os.path.exists(output_path): - output = json.load(open(output_path)) - else: - output = {} - - for instance in dataset: - # Dict{'patient': Str(patient), '0': Str(NCTID), ...} - patient_id = instance["patient_id"] - patient = instance["patient"] - sents = sent_tokenize(patient) - sents.append("The patient will provide informed consent, and will comply with the trial protocol without any practical issues.") - sents = [f"{idx}. {sent}" for idx, sent in enumerate(sents)] - patient = "\n".join(sents) - - # initialize the patient id in the output - if patient_id not in output: - output[patient_id] = {"0": {}, "1": {}, "2": {}} - - for label in ["2", "1", "0"]: - if label not in instance: continue - - for trial in instance[label]: - trial_id = trial["NCTID"] - - # already calculated and cached - if trial_id in output[patient_id][label]: - continue - - # in case anything goes wrong (e.g., API calling errors) - try: - results = trialgpt_matching(trial, patient, model) - output[patient_id][label][trial_id] = results - - with open(output_path, "w") as f: - json.dump(output, f, indent=4) - - except Exception as e: - print(e) - continue + args = parse_arguments() + main(args) \ No newline at end of file diff --git a/trialgpt_ranking/TrialGPT.py b/trialgpt_ranking/TrialGPT.py deleted file mode 100644 index 0bd19e9..0000000 --- a/trialgpt_ranking/TrialGPT.py +++ /dev/null @@ -1,120 +0,0 @@ -__author__ = "qiao" - -""" -TrialGPT-Ranking main functions. -""" - -import json -from nltk.tokenize import sent_tokenize -import time -import os - -from openai import AzureOpenAI - -client = AzureOpenAI( - api_version="2023-09-01-preview", - azure_endpoint=os.getenv("OPENAI_ENDPOINT"), - api_key=os.getenv("OPENAI_API_KEY"), -) - -def convert_criteria_pred_to_string( - prediction: dict, - trial_info: dict, -) -> str: - """Given the TrialGPT prediction, output the linear string of the criteria.""" - output = "" - - for inc_exc in ["inclusion", "exclusion"]: - - # first get the idx2criterion dict - idx2criterion = {} - criteria = trial_info[inc_exc + "_criteria"].split("\n\n") - - idx = 0 - for criterion in criteria: - criterion = criterion.strip() - - if "inclusion criteria" in criterion.lower() or "exclusion criteria" in criterion.lower(): - continue - - if len(criterion) < 5: - continue - - idx2criterion[str(idx)] = criterion - idx += 1 - - for idx, info in enumerate(prediction[inc_exc].items()): - criterion_idx, preds = info - - if criterion_idx not in idx2criterion: - continue - - criterion = idx2criterion[criterion_idx] - - if len(preds) != 3: - continue - - output += f"{inc_exc} criterion {idx}: {criterion}\n" - output += f"\tPatient relevance: {preds[0]}\n" - if len(preds[1]) > 0: - output += f"\tEvident sentences: {preds[1]}\n" - output += f"\tPatient eligibility: {preds[2]}\n" - - return output - - -def convert_pred_to_prompt( - patient: str, - pred: dict, - trial_info: dict, -) -> str: - """Convert the prediction to a prompt string.""" - # get the trial string - trial = f"Title: {trial_info['brief_title']}\n" - trial += f"Target conditions: {', '.join(trial_info['diseases_list'])}\n" - trial += f"Summary: {trial_info['brief_summary']}" - - # then get the prediction strings - pred = convert_criteria_pred_to_string(pred, trial_info) - - # construct the prompt - prompt = "You are a helpful assistant for clinical trial recruitment. You will be given a patient note, a clinical trial, and the patient eligibility predictions for each criterion.\n" - prompt += "Your task is to output two scores, a relevance score (R) and an eligibility score (E), between the patient and the clinical trial.\n" - prompt += "First explain the consideration for determining patient-trial relevance. Predict the relevance score R (0~100), which represents the overall relevance between the patient and the clinical trial. R=0 denotes the patient is totally irrelevant to the clinical trial, and R=100 denotes the patient is exactly relevant to the clinical trial.\n" - prompt += "Then explain the consideration for determining patient-trial eligibility. Predict the eligibility score E (-R~R), which represents the patient's eligibility to the clinical trial. Note that -R <= E <= R (the absolute value of eligibility cannot be higher than the relevance), where E=-R denotes that the patient is ineligible (not included by any inclusion criteria, or excluded by all exclusion criteria), E=R denotes that the patient is eligible (included by all inclusion criteria, and not excluded by any exclusion criteria), E=0 denotes the patient is neutral (i.e., no relevant information for all inclusion and exclusion criteria).\n" - prompt += 'Please output a JSON dict formatted as Dict{"relevance_explanation": Str, "relevance_score_R": Float, "eligibility_explanation": Str, "eligibility_score_E": Float}.' - - - user_prompt = "Here is the patient note:\n" - user_prompt += patient + "\n\n" - user_prompt += "Here is the clinical trial description:\n" - user_prompt += trial + "\n\n" - user_prompt += "Here are the criterion-level eligibility prediction:\n" - user_prompt += pred + "\n\n" - user_prompt += "Plain JSON output:" - - return prompt, user_prompt - - -def trialgpt_aggregation(patient: str, trial_results: dict, trial_info: dict, model: str): - system_prompt, user_prompt = convert_pred_to_prompt( - patient, - trial_results, - trial_info - ) - - messages = [ - {"role": "system", "content": system_prompt}, - {"role": "user", "content": user_prompt} - ] - - response = client.chat.completions.create( - model=model, - messages=messages, - temperature=0, - ) - result = response.choices[0].message.content.strip() - result = result.strip("`").strip("json") - result = json.loads(result) - - return result diff --git a/trialgpt_ranking/__init__.py b/trialgpt_ranking/__init__.py new file mode 100644 index 0000000..138606b --- /dev/null +++ b/trialgpt_ranking/__init__.py @@ -0,0 +1,38 @@ +# trialgpt_ranking/__init__.py +import os +import sys + +# Add the project root directory to the Python path +sys.path.append(os.path.dirname(os.path.dirname(os.path.abspath(__file__)))) + +from .rank_results import ( + parse_arguments as rank_parse_arguments, + get_matching_score, + get_agg_score, + main as rank_main +) + +from .run_aggregation import ( + parse_arguments as agg_parse_arguments, + load_data, + main as agg_main +) + +from .trialgpt_aggregation import ( + convert_criteria_pred_to_string, + convert_pred_to_prompt, + trialgpt_aggregation +) + +__all__ = [ + 'rank_parse_arguments', + 'get_matching_score', + 'get_agg_score', + 'rank_main', + 'agg_parse_arguments', + 'load_data', + 'agg_main', + 'convert_criteria_pred_to_string', + 'convert_pred_to_prompt', + 'trialgpt_aggregation' +] \ No newline at end of file diff --git a/trialgpt_ranking/rank_results.py b/trialgpt_ranking/rank_results.py index 93866e0..d73f619 100644 --- a/trialgpt_ranking/rank_results.py +++ b/trialgpt_ranking/rank_results.py @@ -4,117 +4,263 @@ Rank the trials given the matching and aggregation results """ +import argparse import json +import math +import os import sys +import traceback +import numpy as np +from tqdm import tqdm + +# Add the project root directory to the Python path +sys.path.append(os.path.dirname(os.path.dirname(os.path.abspath(__file__)))) +from common.utils import load_corpus_details eps = 1e-9 +def parse_arguments(): + """Parse and validate command-line arguments.""" + parser = argparse.ArgumentParser(description="Rank trials based on matching and aggregation results.") + parser.add_argument("matching_results_path", help="Path to the matching results JSON file") + parser.add_argument("agg_results_path", help="Path to the aggregation results JSON file") + parser.add_argument("overwrite", help="Overwrite existing results (true/false)") + parser.add_argument("corpus", help="Corpus name") + parser.add_argument("model", help="Model name") + return parser.parse_args() + def get_matching_score(matching): - # count only the valid ones - included = 0 - not_inc = 0 - na_inc = 0 - no_info_inc = 0 - - excluded = 0 - not_exc = 0 - na_exc = 0 - no_info_exc = 0 - - # first count inclusions - for criteria, info in matching["inclusion"].items(): - - if len(info) != 3: - continue - - if info[2] == "included": - included += 1 - elif info[2] == "not included": - not_inc += 1 - elif info[2] == "not applicable": - na_inc += 1 - elif info[2] == "not enough information": - no_info_inc += 1 - - # then count exclusions - for criteria, info in matching["exclusion"].items(): - - if len(info) != 3: - continue - - if info[2] == "excluded": - excluded += 1 - elif info[2] == "not excluded": - not_exc += 1 - elif info[2] == "not applicable": - na_exc += 1 - elif info[2] == "not enough information": - no_info_exc += 1 - - # get the matching score - score = 0 - - score += included / (included + not_inc + no_info_inc + eps) - - if not_inc > 0: - score -= 1 - - if excluded > 0: - score -= 1 - - return score + """ + Calculate the matching score based on inclusion and exclusion criteria. + + Args: + matching (dict): Dictionary containing matching results for inclusion and exclusion criteria. + + Returns: + float: The calculated matching score. + """ + + # count only the valid ones + included = 0 + not_inc = 0 + na_inc = 0 + no_info_inc = 0 + + excluded = 0 + not_exc = 0 + na_exc = 0 + no_info_exc = 0 + + # first count inclusions + for criteria, info in matching["inclusion"].items(): + + if len(info) != 3: + continue + + if info[2] == "included": + included += 1 + elif info[2] == "not included": + not_inc += 1 + elif info[2] == "not applicable": + na_inc += 1 + elif info[2] == "not enough information": + no_info_inc += 1 + + # then count exclusions + for criteria, info in matching["exclusion"].items(): + + if len(info) != 3: + continue + + if info[2] == "excluded": + excluded += 1 + elif info[2] == "not excluded": + not_exc += 1 + elif info[2] == "not applicable": + na_exc += 1 + elif info[2] == "not enough information": + no_info_exc += 1 + # get the matching score + score = 0 + + score += included / (included + not_inc + no_info_inc + eps) + + # if not_inc > 0: + # score -= 1 + # + # if excluded > 0: + # score -= 1 #note max score is 1 min score is ~-2 + + if not_inc > 0 or excluded > 0: + score -= 1 + + return score #note max score is 1 min score is -1 def get_agg_score(assessment): - try: - rel_score = float(assessment["relevance_score_R"]) - eli_score = float(assessment["eligibility_score_E"]) - except: - rel_score = 0 - eli_score = 0 - - score = (rel_score + eli_score) / 100 + """ + Calculate the aggregation score based on relevance and eligibility scores. + + Args: + assessment (dict): Dictionary containing relevance and eligibility scores. + + Returns: + + """ + try: + rel_score = float(assessment["relevance_score_R"]) + eli_score = float(assessment["eligibility_score_E"]) + rel_explanation = assessment.get("relevance_explanation", "No explanation provided") + eli_explanation = assessment.get("eligibility_explanation", "No explanation provided") + except: + rel_score = 0 + eli_score = 0 + rel_explanation = "No explanation provided" + eli_explanation = "No explanation provided" + + # score = (rel_score + eli_score) / 100 # original equation (2>a>0) + score = (eli_score) / 100 # I think the model can give -1Excluded, 0Not Relevant, 1Eligible (1>a>-1) + + return score, rel_explanation, eli_explanation + + +def main(args): + """ + Main function to rank trials based on matching and aggregation results. + + Args: + args (argparse.Namespace): Parsed command-line arguments. + """ + # Loading the results + with open(args.matching_results_path, 'r') as f: + matching_results = json.load(f) + with open(args.agg_results_path, 'r') as f: + agg_results = json.load(f) + + # Load corpus details using the common utility function + corpus_details = load_corpus_details(f"dataset/{args.corpus}/corpus.jsonl") + + # Load patient summaries + with open(f"results/retrieval_keywords_{args.model}_{args.corpus}.json", 'r') as f: + patient_summaries = json.load(f) + + # Set output directory + output_dir = "results/trial_rankings" + os.makedirs(output_dir, exist_ok=True) + + # Check if all_rankings.json exists and if we should overwrite + all_rankings_file = os.path.join(output_dir, "all_rankings.json") + if os.path.exists(all_rankings_file) and args.overwrite.lower() != 'true': + print(f"Loading existing rankings from {all_rankings_file}") + with open(all_rankings_file, 'r') as f: + all_rankings = json.load(f) + else: + all_rankings = {} + + # For qrels-like output + qrels_output = [] + + # Loop over the patients + for patient_id, label2trial2results in tqdm(matching_results.items(), desc="Processing patients"): + # Skip if patient already processed and not overwriting + if patient_id in all_rankings and args.overwrite.lower() != 'true': + continue + + patient_summary = patient_summaries.get(patient_id, {}).get('summary', 'No summary available') + trial2scores = {} + try: + for _, trial2results in label2trial2results.items(): + for trial_id, results in trial2results.items(): + matching_score = get_matching_score(results) + + if patient_id not in agg_results or trial_id not in agg_results[patient_id]: + print(f"Patient {patient_id} Trial {trial_id} not in the aggregation results.") + agg_score = 0 + rel_explanation = "No explanation provided" + eli_explanation = "No explanation provided" + else: + agg_score, rel_explanation, eli_explanation = get_agg_score(agg_results[patient_id][trial_id]) + + trial_score = matching_score + agg_score # (1>m>-2) + (1>a>-1) + + matching_score = np.round(matching_score, decimals=5) + agg_score = np.round(agg_score, decimals=5) + trial_score = np.round(trial_score, decimals=5) + + # Generate qrels-like output using the combined score + # Map the combined score to the TREC scoring system + # TODO expose the 0.5 and -0.5 to argparse as ELIGIBILITY/EXCLUSION + if trial_score > 0.5: + qrels_score = 2 # Eligible + elif trial_score > -0.5: + qrels_score = 0 # Not Relevant + else: + qrels_score = 1 # Excluded + + qrels_output.append(f"{patient_id}\t{trial_id}\t{qrels_score}") + + trial2scores[trial_id] = { + "matching_score": matching_score, + "agg_score": agg_score, + "trial_score": trial_score, + "qrels_score": qrels_score, + "brief_summary": corpus_details.get(trial_id, {}).get("brief_summary", "No summary available"), + "relevance_explanation": rel_explanation, + "eligibility_explanation": eli_explanation + } + + sorted_trial2scores = sorted(trial2scores.items(), key=lambda x: -x[1]["trial_score"]) + + # Save to individual text file + # Update the individual text file writing section + output_file = os.path.join(output_dir, f"trialranking_{patient_id}.txt") + with open(output_file, 'w') as f: + f.write(f"Patient ID: {patient_id}\n") + f.write(f"Patient Summary: {patient_summary}\n\n") + f.write("Clinical trial ranking:\n") + for trial, scores in sorted_trial2scores: + f.write(f"{trial}: matching_score={scores['matching_score']}, " + f"agg_score={scores['agg_score']}, " + f"trial_score={scores['trial_score']}, " + f"qrels_score={scores['qrels_score']}\n") + f.write(f"Brief Summary: {scores['brief_summary']}\n") + f.write(f"Relevance Explanation: {scores['relevance_explanation']}\n") + f.write(f"Eligibility Explanation: {scores['eligibility_explanation']}\n\n") + + print(f"Ranking saved to {output_file}") + + all_rankings[patient_id] = { + "patient_summary": patient_summary, + "trials": {trial_id: { + "matching_score": scores["matching_score"], + "agg_score": scores["agg_score"], + "trial_score": scores["trial_score"], + "qrels_score": scores["qrels_score"], + "brief_summary": scores["brief_summary"], + "relevance_explanation": scores["relevance_explanation"], + "eligibility_explanation": scores["eligibility_explanation"] + } for trial_id, scores in sorted_trial2scores} + } + + except Exception as e: + print(f"An error occurred while processing patient {patient_id}:") + print(traceback.format_exc()) + print("Continuing with the next patient...") + + # Save all rankings to a single JSON file + with open(all_rankings_file, 'w') as f: + json.dump(all_rankings, f, indent=2) + + print(f"All rankings saved to {all_rankings_file}") + + # Save qrels-like output + qrels_path = f"results/qrels_{args.corpus}_{args.model}.txt" + with open(qrels_path, 'w') as f: + f.write('\n'.join(qrels_output)) - return score + print(f"Qrels-like output saved to {qrels_path}") if __name__ == "__main__": - # args are the results paths - matching_results_path = sys.argv[1] - agg_results_path = sys.argv[2] - - # loading the results - matching_results = json.load(open(matching_results_path)) - agg_results = json.load(open(agg_results_path)) - - # loop over the patients - for patient_id, label2trial2results in matching_results.items(): - - trial2score = {} - - for _, trial2results in label2trial2results.items(): - for trial_id, results in trial2results.items(): - - matching_score = get_matching_score(results) - - if patient_id not in agg_results or trial_id not in agg_results[patient_id]: - print(f"Patient {patient_id} Trial {trial_id} not in the aggregation results.") - agg_score = 0 - else: - agg_score = get_agg_score(agg_results[patient_id][trial_id]) - - trial_score = matching_score + agg_score - - trial2score[trial_id] = trial_score - - sorted_trial2score = sorted(trial2score.items(), key=lambda x: -x[1]) - - print() - print(f"Patient ID: {patient_id}") - print("Clinical trial ranking:") - - for trial, score in sorted_trial2score: - print(trial, score) - - print("===") - print() + args = parse_arguments() + main(args) \ No newline at end of file diff --git a/trialgpt_ranking/run_aggregation.py b/trialgpt_ranking/run_aggregation.py index 00b3307..10c5715 100644 --- a/trialgpt_ranking/run_aggregation.py +++ b/trialgpt_ranking/run_aggregation.py @@ -1,78 +1,157 @@ __author__ = "qiao" """ -Using GPT to aggregate the scores by itself. +Using GPT or Llama to aggregate the scores by itself. """ -from beir.datasets.data_loader import GenericDataLoader +import argparse import json -from nltk.tokenize import sent_tokenize import os import sys -import time -from TrialGPT import trialgpt_aggregation +from nltk.tokenize import sent_tokenize +from tqdm import tqdm + +from trialgpt_aggregation import trialgpt_aggregation + +# Add the project root directory to the Python path +sys.path.append(os.path.dirname(os.path.dirname(os.path.abspath(__file__)))) + +from common.utils import load_corpus_details, setup_model, generate_response + + +def parse_arguments(): + """Parse and validate command-line arguments.""" + parser = argparse.ArgumentParser(description="Run TrialGPT aggregation for specified corpus and model.") + parser.add_argument("corpus", help="Corpus name") + parser.add_argument("model", help="Model to use for aggregation") + parser.add_argument("matching_results_path", help="Path to the matching results file") + parser.add_argument("overwrite", help="Overwrite existing results (true/false)") + parser.add_argument("-g", "--num_gpus", help="The number of GPUs to use for model distribution") + parser.add_argument("-d", "--checkpoint_dir", help="Checkpoint directory for Llama models") + parser.add_argument("-q", "--quantize", action="store_true", help="Use 8-bit quantization for Llama models") + return parser.parse_args() + +def load_data(retrieved_trials_path, corpus_path): + """ + Load necessary data from files. + + Args: + retrieved_trials_path (str): Path to the retrieved trials JSON file. + corpus_path (str): Path to the corpus JSONL file. + + Returns: + tuple: Contains retrieved trials data and trial info dictionary. + """ + with open(retrieved_trials_path, 'r') as f: + retrieved_trials = json.load(f) + + trial2info = load_corpus_details(corpus_path) + + return retrieved_trials, trial2info + + +def main(args): + """ + Main function to run the TrialGPT aggregation. + + Args: + args (argparse.Namespace): Parsed command-line arguments. + """ + retrieved_trials, trial2info = load_data( + f"results/retrieved_trials.json", + f"dataset/{args.corpus}/corpus.jsonl" + ) + + output_path = f"results/aggregation_results_{args.corpus}_{args.model}.json" + failed_output_path = f"results/failed_aggregation_results_{args.corpus}_{args.model}.json" + + if args.overwrite.lower() == 'true' or not os.path.exists(output_path): + print(f"Creating new aggregation results for {args.corpus} with {args.model}") + output = {} + failed_outputs = {} + else: + print(f"Loading existing aggregation results for {args.corpus} with {args.model}") + with open(output_path, 'r') as f: + output = json.load(f) + if os.path.exists(failed_output_path): + with open(failed_output_path, 'r') as f: + failed_outputs = json.load(f) + else: + failed_outputs = {} + + results = json.load(open(args.matching_results_path)) + + # Set up the model + model_type, model_instance = setup_model(args.model, args.num_gpus, args.checkpoint_dir, args.quantize) + + for patient_entry in tqdm(retrieved_trials, desc="Processing patients"): + patient_id = patient_entry["patient_id"] + patient = patient_entry["patient"] + # already done in the data set from load_and_format_patient_descriptions(corpus) + # sents = sent_tokenize(patient) + # sents.append( + # "The patient will provide informed consent, and will comply with the trial protocol without any practical issues.") + # sents = [f"<{idx}.> {sent}" for idx, sent in enumerate(sents)] + # patient = "\n".join(sents) + + if patient_id not in output: + output[patient_id] = {} + if patient_id not in failed_outputs: + failed_outputs[patient_id] = {} + + # TODO: remove the 2 1 0 loop its irrelevant at this stage, but must be removed throughout at the same time. + # Middle progress bar for labels + for label in tqdm(["2", "1", "0"], desc=f"Labels for patient {patient_id}", leave=False): + if label not in patient_entry: + continue + + # Inner progress bar for trials + for trial in tqdm(patient_entry[label], desc=f"Trials for label {label}", leave=False): + trial_id = trial["NCTID"] + + # Skip if already processed and not overwriting + if args.overwrite.lower() != 'true' and trial_id in output[patient_id]: + continue + + trial_results = results.get(patient_id, {}).get(label, {}).get(trial_id) + + if not isinstance(trial_results, dict): + failed_outputs[patient_id][trial_id] = "matching result error" + continue + + trial_info = trial2info.get(trial_id, {}) + + if not trial_info: + print(f"Warning: No trial info found for trial {trial_id}") + failed_outputs[patient_id][trial_id] = "no trial info" + continue + + try: + result = trialgpt_aggregation(patient, trial_results, trial_info, args.model, model_type, model_instance) + output[patient_id][trial_id] = result + except Exception as e: + print(f"Error processing trial {trial_id} for patient {patient_id}: {e}") + failed_outputs[patient_id][trial_id] = str(e) + continue + + # Save after each patient to ensure progress is not lost + with open(output_path, "w") as f: + json.dump(output, f, indent=4) + with open(failed_output_path, "w") as f: + json.dump(failed_outputs, f, indent=4) + + print(f"Aggregation results saved to {output_path}") + print(f"Failed aggregation results saved to {failed_output_path}") + + # Print summary + total_processed = sum(len(patient_data) for patient_data in output.values()) + total_failed = sum(len(patient_data) for patient_data in failed_outputs.values()) + print(f"Total trials processed: {total_processed + total_failed}") + print(f"Successful trials: {total_processed}") + print(f"Failed trials: {total_failed}") + if __name__ == "__main__": - corpus = sys.argv[1] - model = sys.argv[2] - - # the path of the matching results - matching_results_path = sys.argv[3] - results = json.load(open(matching_results_path)) - - # loading the trial2info dict - trial2info = json.load(open("dataset/trial_info.json")) - - # loading the patient info - _, queries, _ = GenericDataLoader(data_folder=f"dataset/{corpus}/").load(split="test") - - # output file path - output_path = f"results/aggregation_results_{corpus}_{model}.json" - - if os.path.exists(output_path): - output = json.load(open(output_path)) - else: - output = {} - - # patient-level - for patient_id, info in results.items(): - # get the patient note - patient = queries[patient_id] - sents = sent_tokenize(patient) - sents.append("The patient will provide informed consent, and will comply with the trial protocol without any practical issues.") - sents = [f"{idx}. {sent}" for idx, sent in enumerate(sents)] - patient = "\n".join(sents) - - if patient_id not in output: - output[patient_id] = {} - - # label-level, 3 label / patient - for label, trials in info.items(): - - # trial-level - for trial_id, trial_results in trials.items(): - # already cached results - if trial_id in output[patient_id]: - continue - - if type(trial_results) is not dict: - output[patient_id][trial_id] = "matching result error" - - with open(output_path, "w") as f: - json.dump(output, f, indent=4) - - continue - - # specific trial information - trial_info = trial2info[trial_id] - - try: - result = trialgpt_aggregation(patient, trial_results, trial_info, model) - output[patient_id][trial_id] = result - - with open(output_path, "w") as f: - json.dump(output, f, indent=4) - - except: - continue + args = parse_arguments() + main(args) \ No newline at end of file diff --git a/trialgpt_ranking/trialgpt_aggregation.py b/trialgpt_ranking/trialgpt_aggregation.py new file mode 100644 index 0000000..866c6c2 --- /dev/null +++ b/trialgpt_ranking/trialgpt_aggregation.py @@ -0,0 +1,217 @@ +__author__ = "qiao" + +""" +TrialGPT-Ranking main functions. +""" + +import json +import os + +from common.utils import generate_response + + +def convert_criteria_pred_to_string( + prediction: dict, + trial_info: dict, +) -> str: + """ + Convert TrialGPT prediction to a linear string of criteria. + + This function takes the structured prediction data and trial information, + and converts it into a more readable, linear string format. It organizes + the information by inclusion and exclusion criteria, and for each criterion, + it provides the full text along with the relevance, evident sentences (if any), + and eligibility predictions. + + Args: + prediction (dict): A dictionary containing the TrialGPT predictions. + trial_info (dict): A dictionary containing information about the clinical trial. + + Returns: + str: A formatted string containing the criteria and their predictions. + """ + output = "" + + # Process both inclusion and exclusion criteria + for inc_exc in ["inclusion", "exclusion"]: + # Create a dictionary to map indices to criteria + idx2criterion = {} + # Split the criteria text by double newlines + criteria = trial_info[inc_exc + "_criteria"].split("\n\n") + + idx = 0 + for criterion in criteria: + criterion = criterion.strip() + + # Skip headers or invalid criteria + if "inclusion criteria" in criterion.lower() or "exclusion criteria" in criterion.lower(): + continue + if len(criterion) < 5: + continue + + # Add valid criterion to the dictionary + idx2criterion[str(idx)] = criterion + idx += 1 + + # Process predictions for each criterion + for idx, info in enumerate(prediction[inc_exc].items()): + criterion_idx, preds = info + + # Skip criteria not in our dictionary + if criterion_idx not in idx2criterion: + continue + + criterion = idx2criterion[criterion_idx] + + # Skip predictions without exactly 3 elements + if len(preds) != 3: + continue + + # Build the output string for this criterion + output += f"{inc_exc} criterion {idx}: {criterion}\n" + output += f"\tPatient relevance: {preds[0]}\n" + # Add evident sentences if they exist + if len(preds[1]) > 0: + output += f"\tEvident sentences: {preds[1]}\n" + output += f"\tPatient eligibility: {preds[2]}\n" + + return output + + +def convert_pred_to_prompt(patient: str, pred: dict, trial_info: dict) -> tuple[str, str]: + """Generate improved system and user prompts for clinical trial relevance and eligibility scoring.""" + + # Construct trial information string + trial = ( + f"Title: {trial_info['brief_title']}\n" + f"Target conditions: {', '.join(trial_info['diseases_list'])}\n" + f"Summary: {trial_info['brief_summary']}" + ) + + # Convert prediction to string + pred_string = convert_criteria_pred_to_string(pred, trial_info) + + # System prompt + system_prompt = """You are a clinical trial recruitment specialist. Your task is to assess patient-trial relevance and eligibility based on a patient note, clinical trial description, and criterion-level eligibility predictions. + +### Instructions: + +1. **Relevance Score (R)**: + - Provide a detailed explanation of why the patient is relevant (or irrelevant) to the clinical trial. + - Predict a relevance score (R) between `0` and `100`: + - `R=0`: The patient is completely irrelevant to the clinical trial. + - `R=100`: The patient is perfectly relevant to the clinical trial. + +2. **Eligibility Score (E)**: + - Provide a detailed explanation of the patient’s eligibility for the clinical trial. + - Predict an eligibility score (E) between `-R` and `R`: + - `E=-R`: The patient is ineligible (meets no inclusion criteria or is excluded by all exclusion criteria). + - `E=0`: Neutral (no relevant information for any criteria is found). + - `E=R`: The patient is fully eligible (meets all inclusion criteria and no exclusion criteria). + +Prioritize accuracy, use standardized medical terminology in your analysis, and ensure that your scores are within the specified ranges (`0 ≤ R ≤ 100` and `-R ≤ E ≤ R`).""" + + # User prompt + user_prompt = f"""Analyze the following information: + +### Patient Note: +{patient} + +### Clinical Trial: +{trial} + +### Criterion-level Eligibility Predictions: +{pred_string} + +### Output Instructions: +- **Provide ONLY a valid JSON object** with the exact structure below: +```json +{{ + "relevance_explanation": "Your detailed reasoning for the relevance score", + "relevance_score_R": float_value_between_0_and_100, + "eligibility_explanation": "Your detailed reasoning for the eligibility score", + "eligibility_score_E": float_value_between_negative_R_and_positive_R +}} +``` + +- **Critical Rules:** + 1. **Do NOT include any text outside of the JSON object.** + 2. All reasoning and additional context **MUST** be included in the `relevance_explanation` and `eligibility_explanation` fields. + 3. Ensure that all values are valid: + - The `relevance_score_R` must be a float between `0` and `100`. + - The `eligibility_score_E` must be a float in the range of `[-relevance_score_R, +relevance_score_R]`. + +### Example Output: +```json +{{ + "relevance_explanation": "The patient has a condition explicitly mentioned in the trial criteria, making this trial highly relevant.", + "relevance_score_R": 85.0, + "eligibility_explanation": "The patient meets most inclusion criteria but is disqualified by one exclusion criterion (hypertension).", + "eligibility_score_E": -20.0 +}} +``` + +- **Additional Notes**: + - Populate all fields, even if explanations are brief. + - If there’s no additional information to provide, use an empty string `""` for the explanation fields. + - **Any text outside the JSON structure will be considered invalid output.** +""" + + return system_prompt, user_prompt + + +def trialgpt_aggregation(patient: str, trial_results: dict, trial_info: dict, model: str, model_type: str, + model_instance: any): + debug_data = [] + debug_filename = f"results/messages_trialgpt_aggregation.json" + system_prompt, user_prompt = convert_pred_to_prompt( + patient, + trial_results, + trial_info + ) + + messages = [ + {"role": "system", "content": system_prompt}, + {"role": "user", "content": user_prompt} + ] + + result = generate_response(model_type, model_instance, messages, model) + result = result.strip("`").strip("json") + + # Prepare the new debug entry + debug_entry = { + "system_prompt": system_prompt, + "user_prompt": user_prompt, + "response": result + } + + # Read existing debug data or create an empty list + if os.path.exists(debug_filename): + with open(debug_filename, 'r') as f: + try: + debug_data = json.load(f) + except json.JSONDecodeError: + debug_data = [] + else: + debug_data = [] + + # Append the new entry + debug_data.append(debug_entry) + + #TODO: make debug optional, would be slow for production datasets + # Write the updated debug data back to the file + with open(debug_filename, 'w') as f: + json.dump(debug_data, f, indent=4) + + try: + result = json.loads(result) + except json.JSONDecodeError: + print(f"Error parsing JSON: {result}") + result = { + "relevance_explanation": "Error parsing JSON", + "relevance_score_R": 0, + "eligibility_explanation": "Error parsing JSON", + "eligibility_score_E": 0 + } + + return result \ No newline at end of file diff --git a/trialgpt_retrieval/__init__.py b/trialgpt_retrieval/__init__.py new file mode 100644 index 0000000..be0ca7b --- /dev/null +++ b/trialgpt_retrieval/__init__.py @@ -0,0 +1,48 @@ +# trialgpt_retrieval/__init__.py + +import os +import sys + +# Add the project root directory to the Python path +sys.path.append(os.path.dirname(os.path.dirname(os.path.abspath(__file__)))) + +from common.utils import load_corpus_details + +from .corpus_index import ( + load_and_format_patient_descriptions, + get_bm25_corpus_index, + batch_encode_corpus, + get_medcpt_corpus_index +) + +from .hybrid_fusion_retrieval import ( + parse_arguments, + load_queries, + load_medcpt_model, + perform_bm25_search, + perform_medcpt_search, + calculate_scores, + assign_relevance_labels +) + +from .keyword_generation import ( + parse_arguments_kg, + get_keyword_generation_messages, +) + +__all__ = [ + 'load_corpus_details', + 'load_and_format_patient_descriptions', + 'get_bm25_corpus_index', + 'batch_encode_corpus', + 'get_medcpt_corpus_index', + 'parse_arguments', + 'load_queries', + 'load_medcpt_model', + 'perform_bm25_search', + 'perform_medcpt_search', + 'calculate_scores', + 'assign_relevance_labels', + 'parse_arguments_kg', + 'get_keyword_generation_messages' +] \ No newline at end of file diff --git a/trialgpt_retrieval/corpus_index.py b/trialgpt_retrieval/corpus_index.py new file mode 100644 index 0000000..01250ac --- /dev/null +++ b/trialgpt_retrieval/corpus_index.py @@ -0,0 +1,239 @@ +# corpus_index.py + +import json +import os + +import faiss +import numpy as np +import torch +import tqdm +from nltk.tokenize import word_tokenize, sent_tokenize +from rank_bm25 import BM25Okapi +from tqdm import tqdm +from transformers import AutoModel, AutoTokenizer + + +def load_and_format_patient_descriptions(corpus): + """ + Load and format patient descriptions from a specified corpus. + + This function reads patient descriptions from a JSONL file, formats each description + by numbering its sentences, and adds a standard closing statement about patient + compliance and consent. + + Args: + corpus (str): The name of the corpus (e.g., 'trec_2021', 'trec_2022', 'sigir'). + + Returns: + dict: A dictionary where keys are patient IDs and values are formatted patient descriptions. + + The formatted description includes: + - Numbered sentences from the original description. + - An additional sentence about patient consent and compliance. + """ + query_file = f"dataset/{corpus}/queries.jsonl" + patients = {} + with open(query_file, 'r') as f: + for line in f: + query = json.loads(line) + text = query['text'] + sentences = sent_tokenize(text) + formatted_text = " ".join([f"<{i}.> {sent}" for i, sent in enumerate(sentences)]) + formatted_text += f" <{len(sentences)}.> The patient will provide informed consent, and will comply with the trial protocol without any practical issues." + patients[query['_id']] = formatted_text + return patients + + +def get_bm25_corpus_index(corpus: str, overwrite: bool) -> tuple[BM25Okapi, list[str]]: + """ + Create or load a BM25 index for a given corpus. + + This function either creates a new BM25 index for the specified corpus or loads + an existing one, depending on the 'overwrite' flag and whether a cached index exists. + + Args: + corpus (str): The name of the corpus to index. + overwrite (bool): If True, always create a new index. If False, use cached index if available. + + Returns: + tuple: A tuple containing: + - BM25Okapi: The BM25 index object. + - list[str]: A list of corpus NCT IDs. + + The function performs the following steps: + 1. Determine the path for the cached corpus index. + 2. If overwrite is True or no cached index exists, create a new index: + - Tokenize the corpus entries, with weighted emphasis on title and condition. + - Save the tokenized corpus and NCT IDs to a JSON file. + 3. If a cached index exists and overwrite is False, load the existing index. + 4. Create and return a BM25Okapi object along with the corpus NCT IDs. + """ + # Define the path for the cached corpus index + corpus_path = os.path.join(f"results/bm25_corpus_{corpus}.json") + + # Always build the index if overwrite is True or if the cache doesn't exist + if overwrite or not os.path.exists(corpus_path): + print("Creating new BM25 index") + tokenized_corpus = [] + corpus_nctids = [] + + # Open and process the corpus file + with open(f"dataset/{corpus}/corpus.jsonl", "r") as f: + for line in f.readlines(): + entry = json.loads(line) + corpus_nctids.append(entry["_id"]) + + # Tokenize with weighting: 3 * title, 2 * condition, 1 * text + tokens = word_tokenize(entry["title"].lower()) * 3 + for disease in entry["metadata"]["diseases_list"]: + tokens += word_tokenize(disease.lower()) * 2 + tokens += word_tokenize(entry["text"].lower()) + + tokenized_corpus.append(tokens) + + # Prepare data for caching + corpus_data = { + "tokenized_corpus": tokenized_corpus, + "corpus_nctids": corpus_nctids, + } + + # Cache the processed corpus data + with open(corpus_path, "w") as f: + json.dump(corpus_data, f, indent=4) + else: + print("Loading existing BM25 index") + # Load the cached corpus data + corpus_data = json.load(open(corpus_path)) + tokenized_corpus = corpus_data["tokenized_corpus"] + corpus_nctids = corpus_data["corpus_nctids"] + + # Create the BM25 index + bm25 = BM25Okapi(tokenized_corpus) + + return bm25, corpus_nctids + +def batch_encode_corpus(corpus: str, batch_size: int = 32) -> tuple[np.ndarray, list[str]]: + """ + Encode a corpus of documents using the MedCPT-Article-Encoder model in batches. + + This function reads a corpus from a JSONL file, encodes the title and text of each document + using the MedCPT-Article-Encoder, and returns the embeddings along with the corresponding NCT IDs. + + Args: + corpus (str): The name of the corpus to encode. This should correspond to a JSONL file + located at f"dataset/{corpus}/corpus.jsonl". + batch_size (int, optional): The number of documents to process in each batch. + Defaults to 32. Adjust based on available GPU memory. + + Returns: + Tuple[np.ndarray, List[str]]: A tuple containing: + - np.ndarray: An array of shape (n_documents, embedding_dim) containing the document embeddings. + - List[str]: A list of NCT IDs corresponding to each embedding. + + Raises: + FileNotFoundError: If the corpus file cannot be found. + RuntimeError: If there's an error during the encoding process. + + Note: + This function requires a CUDA-capable GPU and will move the model and inputs to the GPU. + Ensure you have sufficient GPU memory for the specified batch size. + + """ + corpus_nctids = [] + titles = [] + texts = [] + embeds = [] + + model = AutoModel.from_pretrained("ncbi/MedCPT-Article-Encoder").to("cuda") + tokenizer = AutoTokenizer.from_pretrained("ncbi/MedCPT-Article-Encoder") + + with open(f"dataset/{corpus}/corpus.jsonl", "r") as f: + print("Reading corpus") + for line in tqdm(f, desc="Reading entries"): + entry = json.loads(line) + corpus_nctids.append(entry["_id"]) + titles.append(entry["title"]) + texts.append(entry["text"]) + + print("Encoding the corpus") + for i in tqdm(range(0, len(titles), batch_size), desc="Encoding batches"): + batch_titles = titles[i:i+batch_size] + batch_texts = texts[i:i+batch_size] + + with torch.no_grad(): + # Tokenize the articles + encoded = tokenizer( + list(zip(batch_titles, batch_texts)), + truncation=True, + padding=True, + return_tensors='pt', + max_length=512, + ).to("cuda") + + # Generate embeddings + batch_embeds = model(**encoded).last_hidden_state[:, 0, :] + embeds.append(batch_embeds.cpu().numpy()) + + embeds = np.concatenate(embeds, axis=0) + + return embeds, corpus_nctids + +def get_medcpt_corpus_index(corpus: str, overwrite: bool, batch_size: int = 32) -> tuple[faiss.IndexFlatIP, list[str]]: + """ + Create or load a MedCPT-based corpus index for efficient similarity search. + + This function either generates new embeddings for the corpus using the MedCPT model + or loads pre-computed embeddings, depending on the 'overwrite' flag and cache existence. + It then creates a FAISS index for fast similarity search. + + Args: + corpus (str): The name of the corpus to index. This should correspond to a directory + in the 'dataset' folder containing a 'corpus.jsonl' file. + overwrite (bool): If True, always create new embeddings. If False, use cached embeddings if available. + batch_size (int, optional): Number of documents to process in each batch when creating new embeddings. + Defaults to 32. Adjust based on available GPU memory. + + Returns: + tuple[faiss.IndexFlatIP, list[str]]: A tuple containing: + - faiss.IndexFlatIP: A FAISS index for efficient similarity search. + - list[str]: A list of corpus NCT IDs corresponding to the indexed documents. + + Raises: + FileNotFoundError: If the corpus file or cached embeddings cannot be found. + ValueError: If the loaded embeddings do not match the expected shape or format. + + The function performs the following steps: + 1. Check if cached embeddings exist and whether to overwrite them. + 2. If creating new embeddings: + - Call batch_encode_corpus to generate embeddings for the corpus documents. + - Save the embeddings and NCT IDs to disk for future use. + 3. If using cached embeddings, load them from disk. + 4. Create a FAISS index using the embeddings. + 5. Return the FAISS index and the list of NCT IDs. + + Note: + - This function requires the FAISS library for creating the similarity search index. + - When creating new embeddings, a CUDA-capable GPU is required. + - The cached embeddings are stored as '{corpus}_embeds.npy' and '{corpus}_nctids.json' in the 'results' directory. + + """ + corpus_path = f"results/{corpus}_embeds.npy" + nctids_path = f"results/{corpus}_nctids.json" + + if overwrite or not os.path.exists(corpus_path): + print("Creating new MedCPT index") + embeds, corpus_nctids = batch_encode_corpus(corpus, batch_size) + + np.save(corpus_path, embeds) + with open(nctids_path, "w") as f: + json.dump(corpus_nctids, f, indent=4) + else: + print("Loading existing MedCPT index") + embeds = np.load(corpus_path) + with open(nctids_path, "r") as f: + corpus_nctids = json.load(f) + + index = faiss.IndexFlatIP(embeds.shape[1]) + index.add(embeds) + + return index, corpus_nctids \ No newline at end of file diff --git a/trialgpt_retrieval/hybrid_fusion_retrieval.py b/trialgpt_retrieval/hybrid_fusion_retrieval.py index d6c7dd1..d75dc80 100644 --- a/trialgpt_retrieval/hybrid_fusion_retrieval.py +++ b/trialgpt_retrieval/hybrid_fusion_retrieval.py @@ -3,223 +3,309 @@ """ Conduct the first stage retrieval by the hybrid retriever """ +#nltk.download('punkt') -from beir.datasets.data_loader import GenericDataLoader -import faiss +import argparse import json -from nltk import word_tokenize -import numpy as np import os -from rank_bm25 import BM25Okapi import sys -import tqdm +from collections import defaultdict + +import numpy as np import torch -from transformers import AutoTokenizer, AutoModel - -def get_bm25_corpus_index(corpus): - corpus_path = os.path.join(f"trialgpt_retrieval/bm25_corpus_{corpus}.json") - - # if already cached then load, otherwise build - if os.path.exists(corpus_path): - corpus_data = json.load(open(corpus_path)) - tokenized_corpus = corpus_data["tokenized_corpus"] - corpus_nctids = corpus_data["corpus_nctids"] - - else: - tokenized_corpus = [] - corpus_nctids = [] - - with open(f"dataset/{corpus}/corpus.jsonl", "r") as f: - for line in f.readlines(): - entry = json.loads(line) - corpus_nctids.append(entry["_id"]) - - # weighting: 3 * title, 2 * condition, 1 * text - tokens = word_tokenize(entry["title"].lower()) * 3 - for disease in entry["metadata"]["diseases_list"]: - tokens += word_tokenize(disease.lower()) * 2 - tokens += word_tokenize(entry["text"].lower()) - - tokenized_corpus.append(tokens) - - corpus_data = { - "tokenized_corpus": tokenized_corpus, - "corpus_nctids": corpus_nctids, - } - - with open(corpus_path, "w") as f: - json.dump(corpus_data, f, indent=4) - - bm25 = BM25Okapi(tokenized_corpus) - - return bm25, corpus_nctids - - -def get_medcpt_corpus_index(corpus): - corpus_path = f"trialgpt_retrieval/{corpus}_embeds.npy" - nctids_path = f"trialgpt_retrieval/{corpus}_nctids.json" - - # if already cached then load, otherwise build - if os.path.exists(corpus_path): - embeds = np.load(corpus_path) - corpus_nctids = json.load(open(nctids_path)) - - else: - embeds = [] - corpus_nctids = [] - - model = AutoModel.from_pretrained("ncbi/MedCPT-Article-Encoder").to("cuda") - tokenizer = AutoTokenizer.from_pretrained("ncbi/MedCPT-Article-Encoder") - - with open(f"dataset/{corpus}/corpus.jsonl", "r") as f: - print("Encoding the corpus") - for line in tqdm.tqdm(f.readlines()): - entry = json.loads(line) - corpus_nctids.append(entry["_id"]) - - title = entry["title"] - text = entry["text"] - - with torch.no_grad(): - # tokenize the articles - encoded = tokenizer( - [[title, text]], - truncation=True, - padding=True, - return_tensors='pt', - max_length=512, - ).to("cuda") - - embed = model(**encoded).last_hidden_state[:, 0, :] - - embeds.append(embed[0].cpu().numpy()) - - embeds = np.array(embeds) - - np.save(corpus_path, embeds) - with open(nctids_path, "w") as f: - json.dump(corpus_nctids, f, indent=4) - - index = faiss.IndexFlatIP(768) - index.add(embeds) - - return index, corpus_nctids - +from nltk.tokenize import word_tokenize +from transformers import AutoModel, AutoTokenizer + +# Add the project root directory to the Python path +sys.path.append(os.path.dirname(os.path.dirname(os.path.abspath(__file__)))) + +from common.utils import load_corpus_details +from corpus_index import get_bm25_corpus_index, get_medcpt_corpus_index, load_and_format_patient_descriptions + + +def parse_arguments(): + """ + Parse command-line arguments for the keyword generation script. + + This function sets up the argument parser and defines the required and optional + arguments for the script. + + Returns: + argparse.Namespace: An object containing the parsed arguments. + """ + parser = argparse.ArgumentParser(description="Hybrid Fusion Retrieval for Clinical Trials") + parser.add_argument("corpus", help="Path to the corpus") + parser.add_argument("q_type", help="Model type (e.g., gpt-4o-mini)") + parser.add_argument("k", type=int, help="Parameter for score calculation") + parser.add_argument("bm25_wt", type=float, help="Weight for BM25 scores") + parser.add_argument("medcpt_wt", type=float, help="Weight for MedCPT scores") + parser.add_argument("overwrite", type=str, help="Overwrite existing index (true/false)") + parser.add_argument("top_k", type=int, help="Top K documents to consider (default: 1000)") + parser.add_argument("batch_size", type=int, help="Batch size for processing (default: 32)") + parser.add_argument("eligibility_threshold", type=float, help="Score threshold for eligibility (0-1)") + parser.add_argument("exclusion_threshold", type=float, help="Score threshold for exclusion (0-1)") + return parser.parse_args() + + +def load_queries(corpus, q_type): + """ + Load queries from the specified file. + + Args: + corpus (str): The name of the corpus. + q_type (str): The type of queries. + + Returns: + dict: A dictionary containing the loaded queries. + """ + return json.load(open(f"results/retrieval_keywords_{q_type}_{corpus}.json")) + + +def load_medcpt_model(): + """Load and return the MedCPT query encoder model and tokenizer.""" + model = AutoModel.from_pretrained("ncbi/MedCPT-Query-Encoder").to("cuda") + tokenizer = AutoTokenizer.from_pretrained("ncbi/MedCPT-Query-Encoder") + return model, tokenizer + + +def perform_bm25_search(bm25, bm25_nctids, conditions, N): + """ + Perform BM25 search for each condition. + + Args: + bm25: The BM25 index. + bm25_nctids (list): List of NCT IDs corresponding to the BM25 index. + conditions (list): List of condition strings to search for. + N (int): Number of top results to return for each condition. + + Returns: + list: A list of lists, where each inner list contains the top N NCT IDs for a condition. + """ + return [ + bm25.get_top_n(word_tokenize(condition.lower()), bm25_nctids, n=N) + for condition in conditions + ] + + +def perform_medcpt_search(model, tokenizer, medcpt, medcpt_nctids, conditions, N): + """ + Perform MedCPT search for each condition. + + Args: + model: The MedCPT model. + tokenizer: The MedCPT tokenizer. + medcpt: The MedCPT index. + medcpt_nctids (list): List of NCT IDs corresponding to the MedCPT index. + conditions (list): List of condition strings to search for. + N (int): Number of top results to return for each condition. + + Returns: + list: A list of lists, where each inner list contains the top N NCT IDs for a condition. + """ + with torch.no_grad(): + encoded = tokenizer( + conditions, + truncation=True, + padding=True, + return_tensors='pt', + max_length=512, + ).to("cuda") + # encode the queries (use the [CLS] last hidden states as the representations) + embeds = model(**encoded).last_hidden_state[:, 0, :].cpu().numpy() + # search the Faiss index + scores, inds = medcpt.search(embeds, k=N) + + return [[medcpt_nctids[ind] for ind in ind_list] for ind_list in inds] + + +def calculate_scores(bm25_results, medcpt_results, k, bm25_wt, medcpt_wt): + """ + Calculate combined scores for BM25 and MedCPT results. + + Args: + bm25_results (list): Results from BM25 search. + medcpt_results (list): Results from MedCPT search. + k (int): Parameter for score calculation. + bm25_wt (float): Weight for BM25 scores. + medcpt_wt (float): Weight for MedCPT scores. + + Returns: + tuple: A tuple containing two dictionaries: + - nctid2score: Maps NCT IDs to their total scores. + - nctid2details: Maps NCT IDs to dictionaries containing separate BM25 and MedCPT scores. + """ + nctid2score = {} + nctid2details = {} + for condition_idx, (bm25_top_nctids, medcpt_top_nctids) in enumerate(zip(bm25_results, medcpt_results)): + condition_weight = 1 / (condition_idx + 1) + + if bm25_wt > 0: + for rank, nctid in enumerate(bm25_top_nctids): + bm25_score = (1 / (rank + k)) * condition_weight * bm25_wt + if nctid not in nctid2score: + nctid2score[nctid] = 0 + nctid2details[nctid] = {"bm25_score": 0, "medcpt_score": 0} + nctid2score[nctid] += bm25_score + nctid2details[nctid]["bm25_score"] += bm25_score + + if medcpt_wt > 0: + for rank, nctid in enumerate(medcpt_top_nctids): + medcpt_score = (1 / (rank + k)) * condition_weight * medcpt_wt + if nctid not in nctid2score: + nctid2score[nctid] = 0 + nctid2details[nctid] = {"bm25_score": 0, "medcpt_score": 0} + nctid2score[nctid] += medcpt_score + nctid2details[nctid]["medcpt_score"] += medcpt_score + + return nctid2score, nctid2details + + +def assign_relevance_labels(retrieved_trials, eligibility_threshold, exclusion_threshold): + # TODO: remove this as it's irrelevant at this stage, but must be removed throughout at the same time. + """ + Assign relevance labels to retrieved trials based on the TREC Clinical Trials track criteria. + + Args: + retrieved_trials (dict): Dictionary of retrieved trials with their scores. + eligibility_threshold (float): Score threshold for eligibility (0-1). + exclusion_threshold (float): Score threshold for exclusion (0-1). + + Returns: + defaultdict: A nested defaultdict where the outer key is the query ID, + the inner key is the relevance label (0, 1, or 2), + and the value is a list of trials with that label. + + Note: + The function assigns labels as follows: + - 2: Eligible - The patient is eligible to enroll in the trial. + - 1: Excluded - The patient has the condition that the trial is targeting, + but the exclusion criteria make the patient ineligible. + - 0: Not Relevant - The patient is not relevant for the trial in any way. + """ + # labeled_trials = defaultdict(lambda: defaultdict(list)) + # for qid, trials in retrieved_trials.items(): + # for trial in trials: + # score = trial['total_score'] + # if score >= eligibility_threshold: + # labeled_trials[qid]['2'].append(trial) + # elif score >= exclusion_threshold: + # labeled_trials[qid]['1'].append(trial) + # else: + # labeled_trials[qid]['0'].append(trial) + # + # return labeled_trials + + labeled_trials = defaultdict(lambda: defaultdict(list)) + for qid, trials in retrieved_trials.items(): + labeled_trials[qid]['0'] = trials + + return labeled_trials + + +def main(args): + """ + Main function to perform hybrid fusion retrieval and generate retrieved trials. + + Args: + args (argparse.Namespace): Parsed command-line arguments. + + This function: + 1. Loads necessary data and models + 2. Performs hybrid fusion retrieval using BM25 and MedCPT + 3. Calculates combined scores for retrieved trials + 4. Assigns relevance labels to the retrieved trials + 5. Saves the final output as a JSON file + """ + corpus_details = load_corpus_details(f"dataset/{args.corpus}/corpus.jsonl") + bm25, bm25_nctids = get_bm25_corpus_index(args.corpus, args.overwrite) + medcpt, medcpt_nctids = get_medcpt_corpus_index(args.corpus, args.overwrite, args.batch_size) + patient_descriptions = load_and_format_patient_descriptions(args.corpus) + id2queries = load_queries(args.corpus, args.q_type) + model, tokenizer = load_medcpt_model() + + # Perform hybrid fusion retrieval + retrieved_trials = {} + for qid, patient_desc in patient_descriptions.items(): + conditions = id2queries[qid]["conditions"] + if not conditions: + retrieved_trials[qid] = [] + continue + + bm25_results = perform_bm25_search(bm25, bm25_nctids, conditions, args.top_k) + medcpt_results = perform_medcpt_search(model, tokenizer, medcpt, medcpt_nctids, conditions, args.top_k) + nctid2score, nctid2details = calculate_scores(bm25_results, medcpt_results, args.k, args.bm25_wt, + args.medcpt_wt) + top_nctids = sorted(nctid2score.items(), key=lambda x: -x[1])[:args.top_k] + retrieved_trials[qid] = [ + { + "nct_id": nctid, + **corpus_details[nctid], + "total_score": score, + "bm25_score": nctid2details[nctid]["bm25_score"], + "medcpt_score": nctid2details[nctid]["medcpt_score"] + } + for nctid, score in top_nctids + ] + + # Generate retrieved trials with relevance labels + labeled_trials = assign_relevance_labels(retrieved_trials, args.eligibility_threshold, args.exclusion_threshold) + + final_output = [] + # TODO: remove the 2 1 0 loop its irrelevant at this stage, but must be removed throughout at the same time. + for qid, trials_by_label in labeled_trials.items(): + patient_entry = { + "patient_id": qid, + "patient": patient_descriptions[qid], + "0": trials_by_label['0'], + "1": trials_by_label['1'], + "2": trials_by_label['2'] + } + final_output.append(patient_entry) + + # Save retrieved trials with relevance labels + output_path = f"results/retrieved_trials.json" + with open(output_path, 'w') as f: + json.dump(final_output, f, indent=4) + + print(f"Retrieved trials saved to {output_path}") + + # Calculate and print the requested statistics + total_trials = sum(len(patient['0'] + patient['1'] + patient['2']) for patient in final_output) + eligible_count = sum(len(patient['2']) for patient in final_output) + excluded_count = sum(len(patient['1']) for patient in final_output) + not_relevant_count = sum(len(patient['0']) for patient in final_output) + + print(f"Total trials processed: {total_trials}") + print(f"Eligible trials: {eligible_count} ({eligible_count / total_trials:.2%})") + print(f"Excluded trials: {excluded_count} ({excluded_count / total_trials:.2%})") + print(f"Not relevant trials: {not_relevant_count} ({not_relevant_count / total_trials:.2%})") + + # Calculate total_score distribution + all_scores = [trial['total_score'] for patient in final_output for trials in patient.values() if + isinstance(trials, list) for trial in trials] + all_scores.sort() + + percentiles = [0, 10, 25, 33, 50, 66, 70, 80, 90, 100] + percentile_values = [np.percentile(all_scores, p) for p in percentiles] + + print("\nTotal Score Distribution:") + print(f"Min: {min(all_scores):.4f}") + print(f"Max: {max(all_scores):.4f}") + print(f"Average: {np.mean(all_scores):.4f}") + + # Calculate mode manually + from collections import Counter + mode_value = Counter(all_scores).most_common(1)[0][0] + print(f"Mode: {mode_value:.4f}") + + print("Percentiles:") + for p, v in zip(percentiles, percentile_values): + print(f"{p}th: {v:.4f}") if __name__ == "__main__": - # different corpora, "trec_2021", "trec_2022", "sigir" - corpus = sys.argv[1] - - # query type - q_type = sys.argv[2] - - # different k for fusion - k = int(sys.argv[3]) - - # bm25 weight - bm25_wt = int(sys.argv[4]) - - # medcpt weight - medcpt_wt = int(sys.argv[5]) - - # how many to rank - N = 2000 - - # loading the qrels - _, _, qrels = GenericDataLoader(data_folder=f"dataset/{corpus}/").load(split="test") - - # loading all types of queries - id2queries = json.load(open(f"dataset/{corpus}/id2queries.json")) - - # loading the indices - bm25, bm25_nctids = get_bm25_corpus_index(corpus) - medcpt, medcpt_nctids = get_medcpt_corpus_index(corpus) - - # loading the query encoder for MedCPT - model = AutoModel.from_pretrained("ncbi/MedCPT-Query-Encoder").to("cuda") - tokenizer = AutoTokenizer.from_pretrained("ncbi/MedCPT-Query-Encoder") - - # then conduct the searches, saving top 1k - output_path = f"results/qid2nctids_results_{q_type}_{corpus}_k{k}_bm25wt{bm25_wt}_medcptwt{medcpt_wt}_N{N}.json" - - qid2nctids = {} - recalls = [] - - with open(f"dataset/{corpus}/queries.jsonl", "r") as f: - for line in tqdm.tqdm(f.readlines()): - entry = json.loads(line) - query = entry["text"] - qid = entry["_id"] - - if qid not in qrels: - continue - - truth_sum = sum(qrels[qid].values()) - - # get the keyword list - if q_type in ["raw", "human_summary"]: - conditions = [id2queries[qid][q_type]] - elif "turbo" in q_type: - conditions = id2queries[qid][q_type]["conditions"] - elif "Clinician" in q_type: - conditions = id2queries[qid].get(q_type, []) - - if len(conditions) == 0: - nctid2score = {} - else: - # a list of nctid lists for the bm25 retriever - bm25_condition_top_nctids = [] - - for condition in conditions: - tokens = word_tokenize(condition.lower()) - top_nctids = bm25.get_top_n(tokens, bm25_nctids, n=N) - bm25_condition_top_nctids.append(top_nctids) - - # doing MedCPT retrieval - with torch.no_grad(): - encoded = tokenizer( - conditions, - truncation=True, - padding=True, - return_tensors='pt', - max_length=256, - ).to("cuda") - - # encode the queries (use the [CLS] last hidden states as the representations) - embeds = model(**encoded).last_hidden_state[:, 0, :].cpu().numpy() - - # search the Faiss index - scores, inds = medcpt.search(embeds, k=N) - - medcpt_condition_top_nctids = [] - for ind_list in inds: - top_nctids = [medcpt_nctids[ind] for ind in ind_list] - medcpt_condition_top_nctids.append(top_nctids) - - nctid2score = {} - - for condition_idx, (bm25_top_nctids, medcpt_top_nctids) in enumerate(zip(bm25_condition_top_nctids, medcpt_condition_top_nctids)): - - if bm25_wt > 0: - for rank, nctid in enumerate(bm25_top_nctids): - if nctid not in nctid2score: - nctid2score[nctid] = 0 - - nctid2score[nctid] += (1 / (rank + k)) * (1 / (condition_idx + 1)) - - if medcpt_wt > 0: - for rank, nctid in enumerate(medcpt_top_nctids): - if nctid not in nctid2score: - nctid2score[nctid] = 0 - - nctid2score[nctid] += (1 / (rank + k)) * (1 / (condition_idx + 1)) - - nctid2score = sorted(nctid2score.items(), key=lambda x: -x[1]) - top_nctids = [nctid for nctid, _ in nctid2score[:N]] - qid2nctids[qid] = top_nctids - - actual_sum = sum([qrels[qid].get(nctid, 0) for nctid in top_nctids]) - recalls.append(actual_sum / truth_sum) - - with open(output_path, "w") as f: - json.dump(qid2nctids, f, indent=4) + args = parse_arguments() + + # Convert overwrite string to boolean + args.overwrite = args.overwrite.lower() == 'true' + + main(args) diff --git a/trialgpt_retrieval/keyword_generation.py b/trialgpt_retrieval/keyword_generation.py index e8a43fa..a9b64a3 100644 --- a/trialgpt_retrieval/keyword_generation.py +++ b/trialgpt_retrieval/keyword_generation.py @@ -1,59 +1,144 @@ -__author__ = "qiao" +#!/usr/bin/env python3 """ -generate the search keywords for each patient +Generate search keywords for patient descriptions using specified model and corpus. """ +import argparse import json import os -from openai import AzureOpenAI - import sys -client = AzureOpenAI( - api_version="2023-09-01-preview", - azure_endpoint=os.getenv("OPENAI_ENDPOINT"), - api_key=os.getenv("OPENAI_API_KEY"), -) +from tqdm import tqdm + +# Add the project root directory to the Python path +sys.path.append(os.path.dirname(os.path.dirname(os.path.abspath(__file__)))) + +from common.utils import setup_model, generate_response + + +def parse_arguments_kg(): + """ + Parse command-line arguments for the keyword generation script. + + This function sets up the argument parser and defines the required and optional + arguments for the script. + + Returns: + argparse.Namespace: An object containing the parsed arguments. + """ + parser = argparse.ArgumentParser(description="Generate search keywords for patient descriptions.") + + # Required arguments + parser.add_argument("-c", "--corpus", required=True, help="The corpus to process: trec_2021, trec_2022, or sigir") + parser.add_argument("-m", "--model", required=True, help="The model to use for generating keywords") + parser.add_argument("-g", "--num_gpus", help="The number of GPUs to use for model distribution") + # Optional arguments + parser.add_argument("-d", "--checkpoint_dir", help="Checkpoint directory for Llama models") + parser.add_argument("-q", "--quantize", action="store_true", help="Use 8-bit quantization for Llama models") + + return parser.parse_args() def get_keyword_generation_messages(note): - system = 'You are a helpful assistant and your task is to help search relevant clinical trials for a given patient description. Please first summarize the main medical problems of the patient. Then generate up to 32 key conditions for searching relevant clinical trials for this patient. The key condition list should be ranked by priority. Please output only a JSON dict formatted as Dict{{"summary": Str(summary), "conditions": List[Str(condition)]}}.' + """ + Prepare the messages for keyword generation based on a patient note. + + Args: + note (str): The patient description. + + Returns: + list: A list of message dictionaries for the AI model. + """ + system = """You are a medical research assistant specializing in clinical trial matching. Your task is to analyze patient descriptions to identify key medical conditions and assist in finding suitable clinical trials. Prioritize accuracy and relevance in your analysis.""" + + prompt = f"""Please analyze the following patient description for clinical trial matching: + + ## {note} + + ### Instructions: + 1. Summarize the patient's main medical issues in 3-5 sentences. + 2. List up to 20 key medical conditions, ranked by relevance for clinical trial matching. + 3. Use standardized medical terminology (e.g., "Type 2 Diabetes" instead of "high blood sugar"). + 4. Include conditions only if explicitly mentioned or strongly implied in the description. + + ### Output a JSON object in this format: + **Provide ONLY a valid JSON object** with the following structure: + {{ + "summary": "Brief patient summary", + "conditions": ["Condition 1", "Condition 2", ...] + }} + + ### Important Notes: + - If you are unsure about a condition, include it only if it is explicitly mentioned or strongly implied in the description. + - **Do NOT include any text outside of the JSON object.** This means no notes, explanations, headers, or footers outside the JSON. + + Now, please process the patient description and respond with the JSON object. + """ + + return [ + {"role": "system", "content": system}, + {"role": "user", "content": prompt} + ] + + +def main(args): + """ + Generate search keywords for patient descriptions using specified model and corpus. + + This function processes patient descriptions from a given corpus using either GPT or Llama models + to generate relevant medical keywords. It saves the results to a JSON file. + """ + outputs = {} + failed_outputs = {} + + model_type, model_instance = setup_model(args.model, args.num_gpus, args.checkpoint_dir, args.quantize) + + # Count total lines in the input file for progress tracking + with open(f"dataset/{args.corpus}/queries.jsonl", "r") as f: + total_lines = sum(1 for _ in f) + + # Process each query in the input file + with open(f"dataset/{args.corpus}/queries.jsonl", "r") as f: + for line in tqdm(f, total=total_lines, desc=f"Processing {args.corpus} queries"): + try: + entry = json.loads(line) + messages = get_keyword_generation_messages(entry["text"]) + output = generate_response(model_type, model_instance, messages, args.model) + + try: + outputs[entry["_id"]] = json.loads(output) + except json.JSONDecodeError: + print(f"Failed to parse JSON for entry {entry['_id']}. Output: {output}") + failed_outputs[entry["_id"]] = { + "error": "Failed to parse JSON", + "raw_output": output + } + except Exception as e: + print(f"Error processing entry {entry['_id']}: {str(e)}") + failed_outputs[entry["_id"]] = { + "error": str(e), + "raw_entry": line + } + + # Save successful outputs + output_file = f"results/retrieval_keywords_{args.model}_{args.corpus}.json" + with open(output_file, "w") as f: + json.dump(outputs, f, indent=4) + print(f"Results saved to {output_file}") - prompt = f"Here is the patient description: \n{note}\n\nJSON output:" + # Save failed outputs + failed_output_file = f"results/failed_retrieval_keywords_{args.model}_{args.corpus}.json" + with open(failed_output_file, "w") as f: + json.dump(failed_outputs, f, indent=4) + print(f"Failed results saved to {failed_output_file}") - messages = [ - {"role": "system", "content": system}, - {"role": "user", "content": prompt} - ] - - return messages + # Print summary + print(f"Total entries processed: {len(outputs) + len(failed_outputs)}") + print(f"Successful entries: {len(outputs)}") + print(f"Failed entries: {len(failed_outputs)}") if __name__ == "__main__": - # the corpus: trec_2021, trec_2022, or sigir - corpus = sys.argv[1] - - # the model index to use - model = sys.argv[2] - - outputs = {} - - with open(f"dataset/{corpus}/queries.jsonl", "r") as f: - for line in f.readlines(): - entry = json.loads(line) - messages = get_keyword_generation_messages(entry["text"]) - - response = client.chat.completions.create( - model=model, - messages=messages, - temperature=0, - ) - - output = response.choices[0].message.content - output = output.strip("`").strip("json") - - outputs[entry["_id"]] = json.loads(output) - - with open(f"results/retrieval_keywords_{model}_{corpus}.json", "w") as f: - json.dump(outputs, f, indent=4) + args = parse_arguments_kg() + main(args)